0000|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0000|002|Z|does NOT have all possible information about this product. This||
0000|003|Z|information does not assure that this product is safe, effective,||
0000|004|Z|or appropriate for you. This information is not individual||
0000|005|Z|medical advice and does not substitute for the advice of your||
0000|006|Z|health care professional. Always ask your health care||
0000|007|Z|professional for complete information about this product and your||
0000|008|Z|specific health needs.||
0000|009|B|||
0000|010|T|NO MONOGRAPH AVAILABLE AT THIS TIME||
0000|011|B|||
0000|012|U|USES:  Consult your pharmacist.||
0000|013|B|||
0000|014|H|HOW TO USE:  Consult your pharmacist.||
0000|015|B|||
0000|016|S|SIDE EFFECTS:  Consult your pharmacist.||
0000|017|S|   In the US -||
0000|018|S|   Call your doctor for medical advice about side effects. You||
0000|019|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0000|020|S|www.fda.gov/medwatch.||
0000|021|S|   In Canada - Call your doctor for medical advice about side||
0000|022|S|effects. You may report side effects to Health Canada at||
0000|023|S|1-866-234-2345.||
0000|024|B|||
0000|025|P|PRECAUTIONS:  Consult your pharmacist.||
0000|026|B|||
0000|027|I|DRUG INTERACTIONS:  Consult your pharmacist.||
0000|028|I|   Keep a list of all your medications with you, and share the||
0000|029|I|list with your doctor and pharmacist.||
0000|030|B|||
0000|031|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0000|032|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0000|033|O|poison control center right away. US residents can call||
0000|034|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0000|035|B|||
0000|036|N|NOTES:  No monograph available at this time.||
0000|037|B|||
0000|038|D|MISSED DOSE:  Consult your pharmacist.||
0000|039|B|||
0000|040|R|STORAGE:  Consult your pharmacist.||
0000|041|R|   Do not flush medications down the toilet or pour them into a||
0000|042|R|drain unless instructed to do so. Properly discard this product||
0000|043|R|when it is expired or no longer needed. Consult your pharmacist||
0000|044|R|or local waste disposal company for more details about how to||
0000|045|R|safely discard your product.||
0000|046|B|||
0000|047|A|Information last revised May 2024.||
0000|048|A|Copyright(c) 2025 First Databank, Inc.||
0000|049|B|||
0001|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0001|002|Z|does NOT have all possible information about this product. This||
0001|003|Z|information does not assure that this product is safe, effective,||
0001|004|Z|or appropriate for you. This information is not individual||
0001|005|Z|medical advice and does not substitute for the advice of your||
0001|006|Z|health care professional. Always ask your health care||
0001|007|Z|professional for complete information about this product and your||
0001|008|Z|specific health needs.||
0001|009|B|||
0001|010|T|ALLOPURINOL - ORAL||
0001|011|F|(AL-oh-PURE-i-nol)||
0001|012|B|||
0001|013|C|COMMON BRAND NAME(S): Zyloprim||
0001|014|B|||
0001|015|U|USES:  Allopurinol is used to treat gout and certain types of||
0001|016|U|kidney stones. It is also used to prevent increased uric acid||
0001|017|U|levels in patients receiving cancer chemotherapy. These patients||
0001|018|U|can have increased uric acid levels due to release of uric acid||
0001|019|U|from the dying cancer cells. Allopurinol works by reducing the||
0001|020|U|amount of uric acid made by the body. Increased uric acid levels||
0001|021|U|can cause gout and kidney problems.||
0001|022|B|||
0001|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
0001|024|H|doctor, usually once daily. Take this medication after a meal to||
0001|025|H|reduce stomach upset. If your dose is more than 300 milligrams a||
0001|026|H|day, you will need to take several smaller doses during the day||
0001|027|H|to get this amount (ask your doctor for directions).||
0001|028|H|   It is best to drink a full glass of water with each dose and||
0001|029|H|at least 8 more glasses (8 ounces each) of fluid a day. If your||
0001|030|H|doctor has directed you to drink less fluid for other medical||
0001|031|H|reasons, consult your doctor for further instructions. Your||
0001|032|H|doctor may also instruct you on how to decrease acid in your||
0001|033|H|urine (such as avoiding large amounts of ascorbic acid/vitamin||
0001|034|H|C).||
0001|035|H|   The dosage is based on your medical condition and response to||
0001|036|H|treatment. Use this medication regularly to get the most benefit||
0001|037|H|from it. To help you remember, take it at the same time(s) each||
0001|038|H|day.||
0001|039|H|   For the treatment of gout, it may take up to several weeks for||
0001|040|H|this medicine to have an effect. You may have more gout attacks||
0001|041|H|for several months after starting this medicine while the body||
0001|042|H|removes extra uric acid. Allopurinol is not a pain reliever. To||
0001|043|H|relieve pain from gout, continue to take your prescribed||
0001|044|H|medicines for gout attacks (such as colchicine, ibuprofen,||
0001|045|H|indomethacin) as directed by your doctor.||
0001|046|H|   Tell your doctor if your condition lasts or gets worse.||
0001|047|B|||
0001|048|S|SIDE EFFECTS:  Stomach upset, nausea, diarrhea, or drowsiness may||
0001|049|S|occur. If any of these effects last or get worse, tell your||
0001|050|S|doctor or pharmacist promptly.||
0001|051|S|   Remember that this medication has been prescribed because your||
0001|052|S|doctor has judged that the benefit to you is greater than the||
0001|053|S|risk of side effects. Many people using this medication do not||
0001|054|S|have serious side effects.||
0001|055|S|   Tell your doctor right away if you have any serious side||
0001|056|S|effects, including: numbness/tingling of arms/legs, easy||
0001|057|S|bleeding/bruising, unusual tiredness, signs of kidney problems||
0001|058|S|(such as change in the amount of urine, painful/bloody||
0001|059|S|urination), signs of liver disease (such as nausea/vomiting that||
0001|060|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
0001|061|S|eyes/skin, dark urine), unusual weight loss, eye pain, vision||
0001|062|S|changes.||
0001|063|S|   Allopurinol may rarely cause very serious (possibly fatal)||
0001|064|S|skin reactions. Some people in certain ethnic groups (such as||
0001|065|S|people of African, Asian, or Native Hawaiian/Pacific Islander||
0001|066|S|descent) are at greater risk. Your doctor may order a blood test||
0001|067|S|to measure your risk before you start this medication. If the||
0001|068|S|blood test shows you are at greater risk, your doctor should||
0001|069|S|discuss the risks and benefits of allopurinol and other treatment||
0001|070|S|choices with you. Get medical help right away if you develop any||
0001|071|S|symptoms of a serious skin reaction, including: skin||
0001|072|S|rash/blisters/peeling, itching, or swelling. Ask your doctor or||
0001|073|S|pharmacist for more details.||
0001|074|S|   A very serious allergic reaction to this drug is rare.||
0001|075|S|However, get medical help right away if you notice any symptoms||
0001|076|S|of a serious allergic reaction, including: fever, swollen lymph||
0001|077|S|nodes, rash, itching/swelling (especially of the||
0001|078|S|face/tongue/throat), severe dizziness, trouble breathing.||
0001|079|S|   This is not a complete list of possible side effects. If you||
0001|080|S|notice other effects not listed above, contact your doctor or||
0001|081|S|pharmacist.||
0001|082|S|   In the US -||
0001|083|S|   Call your doctor for medical advice about side effects. You||
0001|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0001|085|S|www.fda.gov/medwatch.||
0001|086|S|   In Canada - Call your doctor for medical advice about side||
0001|087|S|effects. You may report side effects to Health Canada at||
0001|088|S|1-866-234-2345.||
0001|089|B|||
0001|090|P|PRECAUTIONS:  Before taking allopurinol, tell your doctor or||
0001|091|P|pharmacist if you are allergic to it; or if you have had a severe||
0001|092|P|reaction to it; or if you have any other allergies. This product||
0001|093|P|may contain inactive ingredients, which can cause allergic||
0001|094|P|reactions or other problems. Talk to your pharmacist for more||
0001|095|P|details.||
0001|096|P|   Before using this medication, tell your doctor or pharmacist||
0001|097|P|your medical history, especially of: liver disease, kidney||
0001|098|P|disease, diabetes, high blood pressure (hypertension), unusual||
0001|099|P|diets (such as fasting).||
0001|100|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
0001|101|P|can make you more drowsy. Do not drive, use machinery, or do||
0001|102|P|anything that needs alertness until you can do it safely. Alcohol||
0001|103|P|may also decrease the effectiveness of this drug. Limit alcoholic||
0001|104|P|beverages. Talk to your doctor if you are using marijuana||
0001|105|P|(cannabis).||
0001|106|P|   Before having surgery, tell your doctor or dentist about all||
0001|107|P|the products you use (including prescription drugs,||
0001|108|P|nonprescription drugs, and herbal products).||
0001|109|P|   During pregnancy, this medication should be used only when||
0001|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
0001|111|P|   Allopurinol passes into breast milk and may have undesirable||
0001|112|P|effects on a nursing infant. Consult your doctor before||
0001|113|P|breastfeeding.||
0001|114|B|||
0001|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0001|116|I|medications work or increase your risk for serious side effects.||
0001|117|I|This document does not contain all possible drug interactions.||
0001|118|I|Keep a list of all the products you use (such as||
0001|119|I|prescription/nonprescription drugs and herbal products) and share||
0001|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
0001|121|I|the dosage of any medicines without your doctor's approval.||
0001|122|I|   Some products that may interact with this drug are: "blood||
0001|123|I|thinners" (such as warfarin), capecitabine, didanosine,||
0001|124|I|fezolinetant.||
0001|125|B|||
0001|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0001|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0001|128|O|poison control center right away. US residents can call||
0001|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0001|130|B|||
0001|131|N|NOTES:  Do not share this medication with others.||
0001|132|N|   Lab and/or medical tests (such as uric acid blood levels,||
0001|133|N|liver/kidney function, complete blood count) may be done while||
0001|134|N|you are taking this medication. Keep all medical and lab||
0001|135|N|appointments. Consult your doctor for more details.||
0001|136|N|   If you are taking allopurinol to treat kidney stones, you may||
0001|137|N|benefit from a special diet. Consult your doctor for more||
0001|138|N|details.||
0001|139|B|||
0001|140|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0001|141|D|remember. If it is near the time of the next dose, skip the||
0001|142|D|missed dose. Take your next dose at the regular time. Do not||
0001|143|D|double the dose to catch up.||
0001|144|B|||
0001|145|R|STORAGE:  Store at room temperature away from light and moisture.||
0001|146|R|Do not store in the bathroom. Keep all medications away from||
0001|147|R|children and pets.||
0001|148|R|   Do not flush medications down the toilet or pour them into a||
0001|149|R|drain unless instructed to do so. Properly discard this product||
0001|150|R|when it is expired or no longer needed. Consult your pharmacist||
0001|151|R|or local waste disposal company.||
0001|152|B|||
0001|153|A|Information last revised November 2025.||
0001|154|A|Copyright(c) 2025 First Databank, Inc.||
0001|155|B|||
0002|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0002|002|Z|does NOT have all possible information about this product. This||
0002|003|Z|information does not assure that this product is safe, effective,||
0002|004|Z|or appropriate for you. This information is not individual||
0002|005|Z|medical advice and does not substitute for the advice of your||
0002|006|Z|health care professional. Always ask your health care||
0002|007|Z|professional for complete information about this product and your||
0002|008|Z|specific health needs.||
0002|009|B|||
0002|010|T|AMILORIDE/HYDROCHLOROTHIAZIDE - ORAL||
0002|011|F|(a-MIL-oh-ride/HYE-droe-KLOR-oh-THYE-a-zide)||
0002|012|B|||
0002|013|C|COMMON BRAND NAME(S): Moduretic||
0002|014|B|||
0002|015|W|WARNING:  This product can rarely cause high potassium levels||
0002|016|W|(hyperkalemia). This effect is more likely to occur in older||
0002|017|W|adults and in patients with kidney disease, diabetes, or a||
0002|018|W|serious illness. Potassium levels must be closely monitored on a||
0002|019|W|regular basis while taking this medication. If not treated, very||
0002|020|W|high potassium levels can sometimes be fatal. Tell your doctor||
0002|021|W|right away if you develop any symptoms of high potassium levels,||
0002|022|W|including muscle weakness, slow/irregular heartbeat,||
0002|023|W|numb/tingling skin.||
0002|024|B|||
0002|025|U|USES:  This product is used to treat high blood pressure||
0002|026|U|(hypertension), heart failure, or extra fluid in the body||
0002|027|U|(edema). Lowering high blood pressure helps prevent strokes,||
0002|028|U|heart attacks, and kidney problems.||
0002|029|U|   This product contains two medications: amiloride and||
0002|030|U|hydrochlorothiazide. Both medications are "water pills"||
0002|031|U|(diuretics) and cause your body to get rid of extra salt and||
0002|032|U|water. This effect may increase the amount of urine you make when||
0002|033|U|you first start the product. Amiloride also helps to treat or||
0002|034|U|prevent low blood potassium levels.||
0002|035|B|||
0002|036|H|HOW TO USE:  Take this medication by mouth with food as directed||
0002|037|H|by your doctor, usually once or twice daily. The dosage is based||
0002|038|H|on your medical condition and response to treatment.||
0002|039|H|   If you take this drug too close to bedtime, you may need to||
0002|040|H|wake up to urinate. It is best to take this medication at least 4||
0002|041|H|hours before your bedtime. If you have any questions about how||
0002|042|H|and when to take this medication, ask your doctor or pharmacist.||
0002|043|H|   Use this medication regularly in order to get the most benefit||
0002|044|H|from it. To help you remember, take it at the same time(s) each||
0002|045|H|day. Keep taking this medication even if you feel well. Most||
0002|046|H|people with high blood pressure do not feel sick.||
0002|047|H|   If you also take certain drugs to lower your cholesterol (bile||
0002|048|H|acid-binding resins such as cholestyramine or colestipol), take||
0002|049|H|this product at least 4 hours before or at least 4 to 6 hours||
0002|050|H|after these medications.||
0002|051|H|   Tell your doctor if your condition does not get better or if||
0002|052|H|it gets worse (for example, your blood pressure readings remain||
0002|053|H|high or increase).||
0002|054|B|||
0002|055|S|SIDE EFFECTS:  See also Warning section.||
0002|056|S|   Headache, dizziness, nausea, vomiting, loss of appetite,||
0002|057|S|stomach/abdominal pain, gas, or diarrhea may occur. If any of||
0002|058|S|these effects last or get worse, tell your doctor or pharmacist||
0002|059|S|promptly.||
0002|060|S|   To reduce the risk of dizziness and lightheadedness, get up||
0002|061|S|slowly when rising from a sitting or lying position.||
0002|062|S|   Remember that this medication has been prescribed because your||
0002|063|S|doctor has judged that the benefit to you is greater than the||
0002|064|S|risk of side effects. Many people using this medication do not||
0002|065|S|have serious side effects.||
0002|066|S|   This medication may cause dehydration and electrolyte||
0002|067|S|imbalance. Tell your doctor right away if you have any symptoms||
0002|068|S|of dehydration or electrolyte imbalance, including unusual dry||
0002|069|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0002|070|S|heartbeat, or confusion.||
0002|071|S|   Tell your doctor right away if you have any serious side||
0002|072|S|effects, including: fainting, signs of liver problems (such as||
0002|073|S|nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
0002|074|S|urine), joint pain, signs of kidney problems (such as change in||
0002|075|S|the amount of urine), decrease in vision, eye pain.||
0002|076|S|   A very serious allergic reaction to this drug is rare.||
0002|077|S|However, get medical help right away if you notice any symptoms||
0002|078|S|of a serious allergic reaction, including: rash, itching/swelling||
0002|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0002|080|S|breathing.||
0002|081|S|   This is not a complete list of possible side effects. If you||
0002|082|S|notice other effects not listed above, contact your doctor or||
0002|083|S|pharmacist.||
0002|084|S|   In the US -||
0002|085|S|   Call your doctor for medical advice about side effects. You||
0002|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0002|087|S|www.fda.gov/medwatch.||
0002|088|S|   In Canada - Call your doctor for medical advice about side||
0002|089|S|effects. You may report side effects to Health Canada at||
0002|090|S|1-866-234-2345.||
0002|091|B|||
0002|092|P|PRECAUTIONS:  See also Warning section.||
0002|093|P|   Before taking this product, tell your doctor or pharmacist if||
0002|094|P|you are allergic to amiloride or hydrochlorothiazide; or if you||
0002|095|P|have any other allergies. This product may contain inactive||
0002|096|P|ingredients, which can cause allergic reactions or other||
0002|097|P|problems. Talk to your pharmacist for more details.||
0002|098|P|   Before using this medication, tell your doctor or pharmacist||
0002|099|P|your medical history, especially of: electrolyte imbalance (such||
0002|100|P|as high potassium, low sodium level), kidney disease, liver||
0002|101|P|disease, diabetes, dehydration, lupus, gout, skin cancer.||
0002|102|P|   Before having surgery, tell your doctor or dentist about all||
0002|103|P|the products you use (including prescription drugs,||
0002|104|P|nonprescription drugs, and herbal products).||
0002|105|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0002|106|P|can make you more dizzy. Do not drive, use machinery, or do||
0002|107|P|anything that needs alertness until you can do it safely. Limit||
0002|108|P|alcoholic beverages. Talk to your doctor if you are using||
0002|109|P|marijuana (cannabis).||
0002|110|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0002|111|P|and cause you to feel lightheaded. Tell your doctor if you have||
0002|112|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0002|113|P|of fluids unless your doctor tells you not to.||
0002|114|P|   This medication may make you more sensitive to the sun. It may||
0002|115|P|also increase your risk for skin cancer, especially if you take||
0002|116|P|it for a long time. Limit your time in the sun. Avoid tanning||
0002|117|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0002|118|P|when outdoors. Tell your doctor right away if you get sunburned,||
0002|119|P|have skin blisters/redness, or notice new or changed moles/skin||
0002|120|P|lesions.||
0002|121|P|   If you have diabetes, this product may affect your blood||
0002|122|P|sugar. Check your blood sugar regularly as directed and share the||
0002|123|P|results with your doctor. Tell your doctor right away if you have||
0002|124|P|symptoms of high blood sugar such as increased thirst/urination.||
0002|125|P|Your doctor may need to adjust your diabetes medication, exercise||
0002|126|P|program, or diet.||
0002|127|P|   This product may affect the potassium levels in your blood.||
0002|128|P|Before using potassium supplements or salt substitutes that||
0002|129|P|contain potassium, consult your doctor or pharmacist.||
0002|130|P|   During pregnancy, this medication should be used only when||
0002|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
0002|132|P|   Hydrochlorothiazide passes into breast milk. It is unknown if||
0002|133|P|amiloride passes into breast milk. Consult your doctor before||
0002|134|P|breastfeeding.||
0002|135|B|||
0002|136|I|DRUG INTERACTIONS:  See also How To Use and Precautions section.||
0002|137|I|   Drug interactions may change how your medications work or||
0002|138|I|increase your risk for serious side effects. This document does||
0002|139|I|not contain all possible drug interactions. Keep a list of all||
0002|140|I|the products you use (including prescription/nonprescription||
0002|141|I|drugs and herbal products) and share it with your doctor and||
0002|142|I|pharmacist. Do not start, stop, or change the dosage of any||
0002|143|I|medicines without your doctor's approval.||
0002|144|I|   Some products that may interact with this drug are:||
0002|145|I|dofetilide, lithium, sodium phosphate products, other products||
0002|146|I|that may affect potassium levels (such as eplerenone, tacrolimus,||
0002|147|I|cyclosporine, birth control pills containing drospirenone, other||
0002|148|I|diuretics like spironolactone/triamterene, ACE inhibitors like||
0002|149|I|benazepril/captopril, angiotensin receptor antagonists like||
0002|150|I|losartan/valsartan).||
0002|151|I|   Some products have ingredients that could raise your blood||
0002|152|I|pressure or worsen your heart failure. Tell your pharmacist what||
0002|153|I|products you are using, and ask how to use them safely||
0002|154|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0002|155|I|ibuprofen/naproxen).||
0002|156|I|   This medication may interfere with certain lab tests (such as||
0002|157|I|glucose tolerance testing, parathyroid test, protein-bound iodide||
0002|158|I|test), possibly causing false test results. Make sure lab||
0002|159|I|personnel and all your doctors know you use this drug.||
0002|160|B|||
0002|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0002|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0002|163|O|poison control center right away. US residents can call||
0002|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0002|165|O|Symptoms of overdose may include: severe dizziness, fainting,||
0002|166|O|slow/irregular heartbeat.||
0002|167|B|||
0002|168|N|NOTES:  Do not share this medication with others.||
0002|169|N|   Lifestyle changes such as stress reduction programs, exercise,||
0002|170|N|and dietary changes may increase the effectiveness of this||
0002|171|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0002|172|N|changes that might benefit you.||
0002|173|N|   Lab and/or medical tests (including kidney function, blood||
0002|174|N|mineral levels such as potassium, skin exams, cholesterol levels)||
0002|175|N|should be done while you are taking this medication. Keep all||
0002|176|N|medical and lab appointments. Consult your doctor for more||
0002|177|N|details.||
0002|178|N|   Check your blood pressure regularly while taking this||
0002|179|N|medication, especially when you first start this drug or when||
0002|180|N|your dose is changed. Learn how to monitor your own blood||
0002|181|N|pressure at home, and share the results with your doctor.||
0002|182|B|||
0002|183|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0002|184|D|remember. If it is near the time of the next dose, skip the||
0002|185|D|missed dose. Take your next dose at the regular time. Do not||
0002|186|D|double the dose to catch up.||
0002|187|B|||
0002|188|R|STORAGE:  Store at room temperature away from light and moisture.||
0002|189|R|Do not store in the bathroom. Keep all medications away from||
0002|190|R|children and pets.||
0002|191|R|   Do not flush medications down the toilet or pour them into a||
0002|192|R|drain unless instructed to do so. Properly discard this product||
0002|193|R|when it is expired or no longer needed. Consult your pharmacist||
0002|194|R|or local waste disposal company.||
0002|195|B|||
0002|196|A|Information last revised March 2025.||
0002|197|A|Copyright(c) 2025 First Databank, Inc.||
0002|198|B|||
0003|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0003|002|Z|does NOT have all possible information about this product. This||
0003|003|Z|information does not assure that this product is safe, effective,||
0003|004|Z|or appropriate for you. This information is not individual||
0003|005|Z|medical advice and does not substitute for the advice of your||
0003|006|Z|health care professional. Always ask your health care||
0003|007|Z|professional for complete information about this product and your||
0003|008|Z|specific health needs.||
0003|009|B|||
0003|010|T|ASPIRIN - ORAL||
0003|011|F|(AS-pir-in)||
0003|012|B|||
0003|013|C|COMMON BRAND NAME(S): Bayer Aspirin, Easprin, Ecotrin||
0003|014|B|||
0003|015|U|USES:  Aspirin is used to reduce fever and relieve mild to||
0003|016|U|moderate pain from conditions such as muscle aches, toothaches,||
0003|017|U|common cold, and headaches. It may also be used to reduce pain||
0003|018|U|and swelling in conditions such as arthritis. Aspirin is known as||
0003|019|U|a salicylate and a nonsteroidal anti-inflammatory drug (NSAID).||
0003|020|U|It works by blocking a certain natural substance in your body to||
0003|021|U|reduce pain and swelling. Consult your doctor before treating a||
0003|022|U|child younger than 12 years.||
0003|023|U|   Your doctor may direct you to take a low dose of aspirin to||
0003|024|U|prevent blood clots. This effect reduces the risk of stroke and||
0003|025|U|heart attack. If you have recently had surgery on clogged||
0003|026|U|arteries (such as bypass surgery, carotid endarterectomy,||
0003|027|U|coronary stent), your doctor may direct you to use aspirin in low||
0003|028|U|doses as a "blood thinner" to prevent blood clots.||
0003|029|B|||
0003|030|H|HOW TO USE:  If you are taking this medication for||
0003|031|H|self-treatment, follow all directions on the product package. If||
0003|032|H|you have any questions, ask your doctor or pharmacist. If your||
0003|033|H|doctor has directed you to take this medication, take it exactly||
0003|034|H|as prescribed.||
0003|035|H|   Take this medication by mouth. Drink a full glass of water (8||
0003|036|H|ounces/240 milliliters) with it unless your doctor tells you||
0003|037|H|otherwise. Do not lie down for at least 10 minutes after you have||
0003|038|H|taken this drug. If stomach upset occurs while you are taking||
0003|039|H|this medication, you may take it with food or milk.||
0003|040|H|   Swallow enteric-coated tablets whole. Do not crush or chew||
0003|041|H|enteric-coated tablets. Doing so can increase stomach upset.||
0003|042|H|   Do not crush or chew extended-release tablets or capsules.||
0003|043|H|Doing so can release all of the drug at once, increasing the risk||
0003|044|H|of side effects. Also, do not split extended-release tablets||
0003|045|H|unless they have a score line and your doctor or pharmacist tells||
0003|046|H|you to do so. Swallow the whole or split tablet without crushing||
0003|047|H|or chewing.||
0003|048|H|   The dosage and length of treatment are based on your medical||
0003|049|H|condition and response to treatment. Read the product label to||
0003|050|H|find recommendations on how many tablets you can take in a||
0003|051|H|24-hour period and how long you may self-treat before seeking||
0003|052|H|medical advice. Do not take more medication or take it for longer||
0003|053|H|than recommended unless directed by your doctor. Use the smallest||
0003|054|H|effective dose. Consult your doctor or pharmacist if you have any||
0003|055|H|questions.||
0003|056|H|   If you are taking this medication for self-treatment of||
0003|057|H|headache, get medical help right away if you also have trouble||
0003|058|H|speaking, weakness on one side of the body, or sudden vision||
0003|059|H|changes. Before using this drug, consult a doctor or pharmacist||
0003|060|H|if you have headaches caused by head injury, coughing, or||
0003|061|H|bending, or if you have a headache with vomiting that is severe||
0003|062|H|or doesn't stop, fever, and stiff neck.||
0003|063|H|   If you are taking this medication as needed (not on a regular||
0003|064|H|schedule), remember that pain medications work best if they are||
0003|065|H|used as the first signs of pain occur. If you wait until the pain||
0003|066|H|has worsened, the medicine may not work as well. Aspirin with a||
0003|067|H|special coating (enteric coating) or slow release may take longer||
0003|068|H|to stop pain because it is absorbed more slowly. Ask your doctor||
0003|069|H|or pharmacist to help select the best type of aspirin for you.||
0003|070|H|   You should not take this medication for self-treatment of pain||
0003|071|H|for longer than 10 days. You should not use this drug to||
0003|072|H|self-treat a fever that lasts longer than 3 days. In these cases,||
0003|073|H|consult a doctor because you may have a more serious condition.||
0003|074|H|Tell your doctor promptly if you develop ringing in the ears or||
0003|075|H|difficulty hearing.||
0003|076|H|   If your condition lasts or gets worse (such as new or unusual||
0003|077|H|symptoms, redness/swelling of the painful area, pain/fever that||
0003|078|H|does not go away or gets worse) or if you think you may have a||
0003|079|H|serious medical problem, tell your doctor promptly.||
0003|080|B|||
0003|081|S|SIDE EFFECTS:  Upset stomach and heartburn may occur. If either||
0003|082|S|of these effects last or get worse, tell your doctor or||
0003|083|S|pharmacist promptly.||
0003|084|S|   If your doctor has directed you to use this medication,||
0003|085|S|remember that your doctor has judged that the benefit to you is||
0003|086|S|greater than the risk of side effects. Many people using this||
0003|087|S|medication do not have serious side effects.||
0003|088|S|   Tell your doctor right away if you have any serious side||
0003|089|S|effects, including: nausea/vomiting that is severe or doesn't||
0003|090|S|stop, easy bruising/bleeding, difficulty hearing, ringing in the||
0003|091|S|ears, signs of kidney problems (such as change in the amount of||
0003|092|S|urine), unexplained tiredness, dizziness, dark urine, yellowing||
0003|093|S|eyes/skin.||
0003|094|S|   This drug may rarely cause serious bleeding from the||
0003|095|S|stomach/intestine or other areas of the body. If you notice any||
0003|096|S|of the following very serious side effects, get medical help||
0003|097|S|right away: stomach/abdominal pain that is severe or doesn't go||
0003|098|S|away, black/tarry stools, vomit that looks like coffee grounds,||
0003|099|S|trouble speaking, weakness on one side of the body, sudden vision||
0003|100|S|changes or severe headache.||
0003|101|S|   A very serious allergic reaction to this drug is rare.||
0003|102|S|However, get medical help right away if you notice any symptoms||
0003|103|S|of a serious allergic reaction, including: fever, swollen lymph||
0003|104|S|nodes, rash, itching/swelling (especially of the||
0003|105|S|face/tongue/throat), severe dizziness, trouble breathing.||
0003|106|S|   This is not a complete list of possible side effects. If you||
0003|107|S|notice other effects not listed above, contact your doctor or||
0003|108|S|pharmacist.||
0003|109|S|   In the US -||
0003|110|S|   Call your doctor for medical advice about side effects. You||
0003|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0003|112|S|www.fda.gov/medwatch.||
0003|113|S|   In Canada - Call your doctor for medical advice about side||
0003|114|S|effects. You may report side effects to Health Canada at||
0003|115|S|1-866-234-2345.||
0003|116|B|||
0003|117|P|PRECAUTIONS:  Before taking aspirin, tell your doctor or||
0003|118|P|pharmacist if you are allergic to it; or to other salicylates||
0003|119|P|(such as choline salicylate); or to other pain relievers or fever||
0003|120|P|reducers (NSAIDs such as ibuprofen, naproxen); or if you have any||
0003|121|P|other allergies. This product may contain inactive ingredients,||
0003|122|P|which can cause allergic reactions or other problems. Talk to||
0003|123|P|your pharmacist for more details.||
0003|124|P|   If you have any of the following health problems, consult your||
0003|125|P|doctor or pharmacist before using this medication:||
0003|126|P|bleeding/blood-clotting disorders (such as hemophilia, vitamin K||
0003|127|P|deficiency, low platelet count), kidney disease, liver disease,||
0003|128|P|stomach problems (such as ulcers, heartburn, stomach pain),||
0003|129|P|asthma (including a history of worsening breathing after taking||
0003|130|P|aspirin or other NSAIDs), growths in the nose (nasal polyps),||
0003|131|P|gout, certain enzyme deficiencies (pyruvate kinase or G6PD||
0003|132|P|deficiency).||
0003|133|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0003|134|P|and tobacco, especially when combined with this product, may||
0003|135|P|increase your risk for this side effect. Limit alcoholic||
0003|136|P|beverages, and stop smoking. Check with your doctor or pharmacist||
0003|137|P|for more information.||
0003|138|P|   Before having surgery, tell your doctor or dentist about all||
0003|139|P|the products you use (including prescription drugs,||
0003|140|P|nonprescription drugs, and herbal products).||
0003|141|P|   Children and teenagers less than 18 years old should not take||
0003|142|P|aspirin if they have chickenpox, flu, or any undiagnosed illness||
0003|143|P|or if they have recently received a vaccine. In these cases,||
0003|144|P|taking aspirin increases the risk of Reye's syndrome, a rare but||
0003|145|P|serious illness. Tell your doctor promptly if you see changes in||
0003|146|P|behavior with nausea and vomiting. This may be an early sign of||
0003|147|P|Reye's syndrome.||
0003|148|P|   Older adults may be more sensitive to the side effects of this||
0003|149|P|drug, especially stomach/intestinal bleeding and ulcers.||
0003|150|P|   Aspirin is not recommended for use to treat pain or fever||
0003|151|P|during pregnancy. Before using this medication, women of||
0003|152|P|childbearing age should talk with their doctor(s) about the||
0003|153|P|benefits and risks. Tell your doctor if you are pregnant or if||
0003|154|P|you plan to become pregnant. This medication may harm an unborn||
0003|155|P|baby and cause problems with normal labor/delivery. It is not||
0003|156|P|recommended for use in pregnancy from 20 weeks until delivery. If||
0003|157|P|your doctor decides that you need to use this medication between||
0003|158|P|20 and 30 weeks of pregnancy, you should use the lowest effective||
0003|159|P|dose for the shortest possible time. In some cases, low-dose||
0003|160|P|aspirin (usually 81-162 milligrams a day) may be used safely||
0003|161|P|during pregnancy to prevent certain conditions. Talk to your||
0003|162|P|doctor for more details.||
0003|163|P|   Aspirin passes into breast milk. When used in large amounts||
0003|164|P|(such as to treat pain or fever), it may harm a nursing infant||
0003|165|P|and breastfeeding is not recommended while using this medication.||
0003|166|P|However, low-dose aspirin for heart attack or stroke prevention||
0003|167|P|may be used if directed by your doctor. Consult your doctor||
0003|168|P|before breastfeeding.||
0003|169|B|||
0003|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0003|171|I|medications work or increase your risk for serious side effects.||
0003|172|I|This document does not contain all possible drug interactions.||
0003|173|I|Keep a list of all the products you use (including||
0003|174|I|prescription/nonprescription drugs and herbal products) and share||
0003|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
0003|176|I|the dosage of any medicines without your doctor's approval.||
0003|177|I|   Some products that may interact with this drug include:||
0003|178|I|mifepristone, acetazolamide, "blood thinners" (such as warfarin,||
0003|179|I|heparin), corticosteroids (such as prednisone), dichlorphenamide,||
0003|180|I|methotrexate, valproic acid, herbal medications (such as ginkgo||
0003|181|I|biloba).||
0003|182|I|   Before using this product, consult your doctor if you have||
0003|183|I|recently received certain live vaccines (such as varicella||
0003|184|I|vaccine, live flu vaccine).||
0003|185|I|   Check all prescription and nonprescription medicine labels||
0003|186|I|carefully since many medications contain pain relievers/fever||
0003|187|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
0003|188|I|naproxen). These drugs are similar to this medication and may||
0003|189|I|increase your risk of side effects if taken together.||
0003|190|I|   Daily use of NSAIDs (such as ibuprofen) may decrease aspirin's||
0003|191|I|ability to prevent heart attack/stroke. If you are taking||
0003|192|I|low-dose aspirin for prevention of heart attack/stroke, consult||
0003|193|I|your doctor or pharmacist for more details and to discuss other||
0003|194|I|possible treatments (such as acetaminophen) for your pain/fever.||
0003|195|I|   This medication may interfere with certain lab tests (such as||
0003|196|I|certain urine sugar tests), possibly causing false test results.||
0003|197|I|Make sure lab personnel and all your doctors know you use this||
0003|198|I|drug.||
0003|199|B|||
0003|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0003|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0003|202|O|poison control center right away. US residents can call||
0003|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0003|204|O|Symptoms of overdose may include: burning pain in the||
0003|205|O|throat/stomach, confusion, mental/mood changes, fainting,||
0003|206|O|weakness, ringing in the ears, fever, rapid breathing, change in||
0003|207|O|the amount of urine, seizures, loss of consciousness.||
0003|208|B|||
0003|209|N|NOTES:  If you use this medication regularly or at high doses,||
0003|210|N|lab and/or medical tests (such as liver/kidney function, blood||
0003|211|N|count, salicylate level) may be done while you are taking this||
0003|212|N|medication. Keep all medical and lab appointments. Consult your||
0003|213|N|doctor for more details.||
0003|214|N|   There are many different aspirin products. Some have special||
0003|215|N|coatings and some are long-acting. Ask your doctor or pharmacist||
0003|216|N|to recommend the best product for you.||
0003|217|B|||
0003|218|D|MISSED DOSE:  If your doctor directs you to take this drug on a||
0003|219|D|regular schedule (not just "as needed") and you miss a dose, take||
0003|220|D|it as soon as you remember. If it is near the time of the next||
0003|221|D|dose, skip the missed dose. Take your next dose at the regular||
0003|222|D|time. Do not double the dose to catch up.||
0003|223|B|||
0003|224|R|STORAGE:  Store at room temperature away from moisture and light.||
0003|225|R|Different brands of this medication may have different storage||
0003|226|R|needs. Check the product package for instructions on how to store||
0003|227|R|your brand, or ask your pharmacist. Do not store in the bathroom.||
0003|228|R|Do not use any aspirin product that has a strong vinegar-like||
0003|229|R|smell. Keep all medications away from children and pets.||
0003|230|R|   Do not flush medications down the toilet or pour them into a||
0003|231|R|drain unless instructed to do so. Properly discard this product||
0003|232|R|when it is expired or no longer needed. Consult your pharmacist||
0003|233|R|or local waste disposal company.||
0003|234|B|||
0003|235|A|Information last revised November 2025.||
0003|236|A|Copyright(c) 2025 First Databank, Inc.||
0003|237|B|||
0005|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0005|002|Z|does NOT have all possible information about this product. This||
0005|003|Z|information does not assure that this product is safe, effective,||
0005|004|Z|or appropriate for you. This information is not individual||
0005|005|Z|medical advice and does not substitute for the advice of your||
0005|006|Z|health care professional. Always ask your health care||
0005|007|Z|professional for complete information about this product and your||
0005|008|Z|specific health needs.||
0005|009|B|||
0005|010|T|CARBAMAZEPINE - ORAL||
0005|011|F|(KAR-ba-MAZ-e-peen)||
0005|012|B|||
0005|013|C|COMMON BRAND NAME(S): Tegretol||
0005|014|B|||
0005|015|W|WARNING:  Carbamazepine may rarely cause very serious (possibly||
0005|016|W|fatal) skin reactions. Some people in certain ethnic groups (such||
0005|017|W|as people of Asian/South Asian descent) are at greater risk. Your||
0005|018|W|doctor may order a blood test to measure your risk before you||
0005|019|W|start this medication. If the blood test shows you are at greater||
0005|020|W|risk, your doctor should discuss the risks and benefits of||
0005|021|W|carbamazepine and other treatment choices with you. Such skin||
0005|022|W|reactions have developed mostly within the first few months of||
0005|023|W|treatment. Get medical help right away if you develop any of the||
0005|024|W|following symptoms: skin rash/blisters/peeling, itching, or||
0005|025|W|swelling. Ask your doctor or pharmacist for more details.||
0005|026|W|   This drug has rarely caused very serious blood disorders||
0005|027|W|(aplastic anemia, agranulocytosis). Your doctor will monitor your||
0005|028|W|blood counts to minimize the chance of these side effects. Keep||
0005|029|W|all medical and lab appointments. Get medical help right away if||
0005|030|W|any of these rare but very serious side effects occur: signs of||
0005|031|W|infection (such as sore throat that doesn't go away, fever,||
0005|032|W|chills, swollen lymph nodes), unusual weakness/tiredness,||
0005|033|W|shortness of breath, or easy bleeding/bruising.||
0005|034|B|||
0005|035|U|USES:  Carbamazepine is used to prevent and control seizures.||
0005|036|U|This medication is known as an anticonvulsant or anti-epileptic||
0005|037|U|drug. It is also used to relieve certain types of nerve pain||
0005|038|U|(such as trigeminal neuralgia). This medication works by reducing||
0005|039|U|the spread of seizure activity in the brain and restoring the||
0005|040|U|normal balance of nerve activity.||
0005|041|B|||
0005|042|V|OTHER USES:  This section contains uses of this drug that are not||
0005|043|V|listed in the approved professional labeling for the drug but||
0005|044|V|that may be prescribed by your health care professional. Use this||
0005|045|V|drug for a condition that is listed in this section only if it||
0005|046|V|has been so prescribed by your health care professional.||
0005|047|V|   This drug may also be used for certain mental/mood conditions||
0005|048|V|(such as bipolar disorder) and other types of nerve pain.||
0005|049|B|||
0005|050|H|HOW TO USE:  Read the Medication Guide provided by your||
0005|051|H|pharmacist before you start using carbamazepine and each time you||
0005|052|H|get a refill. If you have any questions, ask your doctor or||
0005|053|H|pharmacist.||
0005|054|H|   Take this medication by mouth with food as directed by your||
0005|055|H|doctor. If you are using the chewable tablets, chew the tablets||
0005|056|H|thoroughly before swallowing.||
0005|057|H|   If you are using the suspension form of this medication, shake||
0005|058|H|the bottle well before each dose. Carefully measure the dose||
0005|059|H|using a special measuring device/spoon. Do not use a household||
0005|060|H|spoon because you may not get the correct dose. Separate doses of||
0005|061|H|the suspension from other liquid medicines by at least 2 hours.||
0005|062|H|   The dosage is based on your medical condition and response to||
0005|063|H|treatment. Children's dosage is also based on weight. To reduce||
0005|064|H|your risk of side effects, your doctor may direct you to start||
0005|065|H|this medication at a low dose and gradually increase your dose.||
0005|066|H|Follow your doctor's instructions carefully.||
0005|067|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0005|068|H|using this medication unless your doctor or pharmacist says you||
0005|069|H|may do so safely. Grapefruit can increase the chance of side||
0005|070|H|effects with this medicine. Ask your doctor or pharmacist for||
0005|071|H|more details.||
0005|072|H|   Take this medication regularly to get the most benefit from||
0005|073|H|it. To help you remember, take it at the same times each day.||
0005|074|H|Keep taking this medication even if you feel well.||
0005|075|H|   Do not stop taking this medication without consulting your||
0005|076|H|doctor. Some conditions (such as seizures) may become worse when||
0005|077|H|this drug is suddenly stopped. Your dose may need to be gradually||
0005|078|H|decreased.||
0005|079|H|   Tell your doctor if your condition does not get better or if||
0005|080|H|it gets worse.||
0005|081|B|||
0005|082|S|SIDE EFFECTS:  See also Warning section.||
0005|083|S|   Nausea, vomiting, dizziness, drowsiness, constipation, dry||
0005|084|S|mouth, or unsteadiness may occur. If any of these effects last or||
0005|085|S|get worse, tell your doctor or pharmacist promptly.||
0005|086|S|   Remember that this medication has been prescribed because your||
0005|087|S|doctor has judged that the benefit to you is greater than the||
0005|088|S|risk of side effects. Many people using this medication do not||
0005|089|S|have serious side effects.||
0005|090|S|   Tell your doctor right away if you have any serious side||
0005|091|S|effects, including: headaches that are severe or don't go away,||
0005|092|S|signs of liver problems (such as nausea/vomiting that doesn't||
0005|093|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
0005|094|S|eyes/skin, dark urine), signs of kidney problems (such as change||
0005|095|S|in the amount of urine), mouth sores, fainting,||
0005|096|S|fast/slow/irregular heartbeat, unusual eye movements (nystagmus),||
0005|097|S|vision changes (such as blurred vision), joint pain, swelling of||
0005|098|S|the ankles/feet, pain/redness/swelling of the arms or legs,||
0005|099|S|numbness/tingling of the hands/feet, signs of low levels of||
0005|100|S|sodium in the blood (such as extreme drowsiness, mental/mood||
0005|101|S|changes including confusion, seizures).||
0005|102|S|   A small number of people who take anticonvulsants for any||
0005|103|S|condition (such as seizure, bipolar disorder, pain) may||
0005|104|S|experience depression, suicidal thoughts/attempts, or other||
0005|105|S|mental/mood problems. Tell your doctor right away if you or your||
0005|106|S|family/caregiver notice any unusual/sudden changes in your mood,||
0005|107|S|thoughts, or behavior including signs of depression, suicidal||
0005|108|S|thoughts/attempts, thoughts about harming yourself.||
0005|109|S|   A very serious allergic reaction to this drug is rare.||
0005|110|S|However, get medical help right away if you notice any symptoms||
0005|111|S|of a serious allergic reaction, including: rash, itching/swelling||
0005|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0005|113|S|breathing.||
0005|114|S|   This is not a complete list of possible side effects. If you||
0005|115|S|notice other effects not listed above, contact your doctor or||
0005|116|S|pharmacist.||
0005|117|S|   In the US -||
0005|118|S|   Call your doctor for medical advice about side effects. You||
0005|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0005|120|S|www.fda.gov/medwatch.||
0005|121|S|   In Canada - Call your doctor for medical advice about side||
0005|122|S|effects. You may report side effects to Health Canada at||
0005|123|S|1-866-234-2345.||
0005|124|B|||
0005|125|P|PRECAUTIONS:  Before taking carbamazepine, tell your doctor or||
0005|126|P|pharmacist if you are allergic to it; or to other anti-seizure||
0005|127|P|medications (such as fosphenytoin, oxcarbazepine, phenobarbital,||
0005|128|P|phenytoin, primidone) or tricyclic antidepressants (such as||
0005|129|P|amitriptyline, desipramine); or if you have any other allergies.||
0005|130|P|This product may contain inactive ingredients (such as propylene||
0005|131|P|glycol in the suspension), which can cause allergic reactions or||
0005|132|P|other problems. Talk to your pharmacist for more details.||
0005|133|P|   Before using this medication, tell your doctor or pharmacist||
0005|134|P|your medical history, especially of: decreased bone marrow||
0005|135|P|function (bone marrow depression), blood disorders (such as||
0005|136|P|porphyria, anemia), glaucoma, heart disease (such as coronary||
0005|137|P|artery disease, heart failure, irregular heartbeat), kidney||
0005|138|P|disease, liver disease, mental/mood disorders (such as||
0005|139|P|depression), mineral imbalances (such as low levels of sodium or||
0005|140|P|calcium in the blood ).||
0005|141|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0005|142|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0005|143|P|machinery, or do anything that needs alertness until you can do||
0005|144|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0005|145|P|are using marijuana (cannabis).||
0005|146|P|   This medication may make you more sensitive to the sun. Limit||
0005|147|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0005|148|P|sunscreen and wear protective clothing when outdoors. Get medical||
0005|149|P|help right away if you get sunburned or have skin||
0005|150|P|blisters/redness.||
0005|151|P|   The chewable tablets or suspension may contain sugar. Caution||
0005|152|P|is advised if you have diabetes or any other condition that||
0005|153|P|requires you to limit/avoid sugar in your diet. Ask your doctor||
0005|154|P|or pharmacist about using this product safely.||
0005|155|P|   Before having surgery, tell your doctor or dentist about all||
0005|156|P|the products you use (including prescription drugs,||
0005|157|P|nonprescription drugs, and herbal products).||
0005|158|P|   Older adults may be more sensitive to the side effects of this||
0005|159|P|drug, especially, confusion, unsteadiness, or irregular||
0005|160|P|heartbeat. Confusion and unsteadiness can increase the risk of||
0005|161|P|falling. Older adults may also be at greater risk of developing a||
0005|162|P|type of mineral imbalance (low levels of sodium in the blood),||
0005|163|P|especially if they are also taking "water pills" (diuretics).||
0005|164|P|   During pregnancy, this medication should be used only when||
0005|165|P|clearly needed. It may harm an unborn baby. However, since||
0005|166|P|untreated seizures are a serious condition that can harm both a||
0005|167|P|pregnant woman and her unborn baby, do not stop taking this||
0005|168|P|medication unless directed by your doctor. If you are planning||
0005|169|P|pregnancy, become pregnant, or think you may be pregnant, discuss||
0005|170|P|with your doctor right away the benefits and risks of using this||
0005|171|P|medication during pregnancy. If you are pregnant, prenatal care||
0005|172|P|that includes tests for birth defects is recommended. Since birth||
0005|173|P|control pills, patches, implants, and injections may not work if||
0005|174|P|used with this medication (see also Drug Interactions section),||
0005|175|P|discuss reliable forms of birth control with your doctor.||
0005|176|P|   This medication passes into breast milk. Consult your doctor||
0005|177|P|before breastfeeding.||
0005|178|B|||
0005|179|I|DRUG INTERACTIONS:  See also How to Use section.||
0005|180|I|   Drug interactions may change how your medications work or||
0005|181|I|increase your risk for serious side effects. This document does||
0005|182|I|not contain all possible drug interactions. Keep a list of all||
0005|183|I|the products you use (including prescription/nonprescription||
0005|184|I|drugs and herbal products) and share it with your doctor and||
0005|185|I|pharmacist. Do not start, stop, or change the dosage of any||
0005|186|I|medicines without your doctor's approval.||
0005|187|I|   Some products that may interact with this drug include:||
0005|188|I|certain azole antifungals (isavuconazonium, voriconazole),||
0005|189|I|orlistat.||
0005|190|I|   Taking MAO inhibitors with this medication may cause a serious||
0005|191|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0005|192|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0005|193|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0005|194|I|selegiline, tranylcypromine) during treatment with this||
0005|195|I|medication. Most MAO inhibitors should also not be taken for two||
0005|196|I|weeks before treatment with this medication. Ask your doctor when||
0005|197|I|to start or stop taking this medication.||
0005|198|I|   Other medications can affect the removal of carbamazepine from||
0005|199|I|your body, which may affect how carbamazepine works. Examples||
0005|200|I|include macrolide antibiotics (such as erythromycin), rifamycins||
0005|201|I|(such as rifabutin), St. John's wort, among others.||
0005|202|I|   Carbamazepine can speed up the removal of other drugs from||
0005|203|I|your body, which may affect how they work. Examples of affected||
0005|204|I|drugs include artemether/lumefantrine, certain drugs used to||
0005|205|I|prevent blood clots (anticoagulants such as apixaban,||
0005|206|I|rivaroxaban), certain calcium channel blockers (such as||
0005|207|I|nifedipine, nimodipine), nefazodone, nirmatrelvir, HIV NNRTIs||
0005|208|I|(such as efavirenz, etravirine, rilpivirine), praziquantel,||
0005|209|I|ranolazine, among others.||
0005|210|I|   This medication may decrease the effectiveness of hormonal||
0005|211|I|birth control such as pills, patch, or ring. This could cause||
0005|212|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0005|213|I|use reliable backup birth control methods while taking this||
0005|214|I|medication. Also tell your doctor if you have any new spotting or||
0005|215|I|breakthrough bleeding, because these may be signs that your birth||
0005|216|I|control is not working well.||
0005|217|I|   Tell your doctor or pharmacist if you are taking other||
0005|218|I|products that cause drowsiness including alcohol, marijuana||
0005|219|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0005|220|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0005|221|I|zolpidem), muscle relaxants (such as carisoprodol,||
0005|222|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
0005|223|I|hydrocodone).||
0005|224|I|   Check the labels on all your medicines (such as allergy or||
0005|225|I|cough-and-cold products) because they may contain ingredients||
0005|226|I|that cause drowsiness. Ask your pharmacist about using those||
0005|227|I|products safely.||
0005|228|I|   This medication may interfere with certain lab tests (such as||
0005|229|I|thyroid function, some pregnancy tests), possibly causing false||
0005|230|I|test results. Make sure lab personnel and all your doctors know||
0005|231|I|you use this drug.||
0005|232|B|||
0005|233|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0005|234|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0005|235|O|poison control center right away. US residents can call||
0005|236|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0005|237|O|Symptoms of overdose may include: slowed breathing, loss of||
0005|238|O|consciousness, muscle twitching, uncontrolled movements, very||
0005|239|O|fast heartbeat.||
0005|240|B|||
0005|241|N|NOTES:  Do not share this medication with others.||
0005|242|N|   Lab and/or medical tests (such as complete blood count, blood||
0005|243|N|mineral levels, kidney/liver function, eye exams, carbamazepine||
0005|244|N|blood levels) should be done before you start taking this||
0005|245|N|medication and while you are taking it. Keep all medical and lab||
0005|246|N|appointments. Consult your doctor for more details.||
0005|247|B|||
0005|248|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0005|249|D|remember. If it is near the time of the next dose, skip the||
0005|250|D|missed dose. Take your next dose at the regular time. Do not||
0005|251|D|double the dose to catch up.||
0005|252|B|||
0005|253|R|STORAGE:  Store at room temperature away from light and moisture.||
0005|254|R|Do not store in the bathroom. Keep all medications away from||
0005|255|R|children and pets.||
0005|256|R|   Do not flush medications down the toilet or pour them into a||
0005|257|R|drain unless instructed to do so. Properly discard this product||
0005|258|R|when it is expired or no longer needed. Consult your pharmacist||
0005|259|R|or local waste disposal company.||
0005|260|B|||
0005|261|M|MEDICAL ALERT:  Your condition can cause complications in a||
0005|262|M|medical emergency. For information about enrolling in MedicAlert,||
0005|263|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0005|264|B|||
0005|265|A|Information last revised October 2025.||
0005|266|A|Copyright(c) 2025 First Databank, Inc.||
0005|267|B|||
0007|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0007|002|Z|does NOT have all possible information about this product. This||
0007|003|Z|information does not assure that this product is safe, effective,||
0007|004|Z|or appropriate for you. This information is not individual||
0007|005|Z|medical advice and does not substitute for the advice of your||
0007|006|Z|health care professional. Always ask your health care||
0007|007|Z|professional for complete information about this product and your||
0007|008|Z|specific health needs.||
0007|009|B|||
0007|010|T|BROMOCRIPTINE - ORAL||
0007|011|F|(BROE-moe-KRIP-teen)||
0007|012|B|||
0007|013|C|COMMON BRAND NAME(S): Parlodel||
0007|014|B|||
0007|015|U|USES:  Bromocriptine is used alone or with other medications||
0007|016|U|(such as levodopa) to treat Parkinson's disease. It can improve||
0007|017|U|your ability to move and can decrease shakiness (tremor),||
0007|018|U|stiffness, slowed movement, and unsteadiness. It may also||
0007|019|U|decrease the number of episodes of not being able to move||
0007|020|U|("on-off syndrome").||
0007|021|U|   Bromocriptine is also used to treat high levels of a certain||
0007|022|U|hormone made by the body (prolactin). High levels of prolactin||
0007|023|U|may cause problems such as unwanted breast milk, missed/stopped||
0007|024|U|periods, difficulty becoming pregnant, decreased sperm||
0007|025|U|production, and decreased sexual ability. Bromocriptine may be||
0007|026|U|used to treat a type of tumor which causes the high levels of||
0007|027|U|prolactin (prolactin-secreting adenomas). It can help to reduce||
0007|028|U|the tumor size. Bromocriptine is not recommended for stopping||
0007|029|U|unwanted breast milk after pregnancy, miscarriage, or abortion||
0007|030|U|because of possible serious side effects (such as high blood||
0007|031|U|pressure, seizure, heart attack, stroke).||
0007|032|U|   Bromocriptine is also used to treat high levels of growth||
0007|033|U|hormone (acromegaly).||
0007|034|U|   Bromocriptine is an ergot medication that works by acting like||
0007|035|U|a certain natural substance (dopamine) in the brain. It also||
0007|036|U|prevents the release of certain hormones (growth hormone,||
0007|037|U|prolactin). Bromocriptine can lower these hormone levels, but it||
0007|038|U|does not cure the causes of the increased levels.||
0007|039|B|||
0007|040|H|HOW TO USE:  Take this medication by mouth with food as directed||
0007|041|H|by your doctor, usually 1 or 2 times daily. The dosage is based||
0007|042|H|on your medical condition and response to treatment. For the||
0007|043|H|treatment of acromegaly, the dosage is also based on the growth||
0007|044|H|hormone levels. To reduce your risk of side effects, your doctor||
0007|045|H|may direct you to start this medication at a low dose and||
0007|046|H|gradually increase your dose. Follow your doctor's instructions||
0007|047|H|carefully.||
0007|048|H|   Take this medication regularly to get the most benefit from||
0007|049|H|it. To help you remember, take it at the same time(s) each day.||
0007|050|H|   Do not stop taking this medication without consulting your||
0007|051|H|doctor. Some conditions may become worse when this medication is||
0007|052|H|suddenly stopped. Also, if you suddenly stop using this||
0007|053|H|medication, you may have withdrawal symptoms (such as anxiety,||
0007|054|H|depression, confusion, fever, muscle stiffness). To help prevent||
0007|055|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0007|056|H|more likely if you have used bromocriptine for a long time or in||
0007|057|H|high doses. Tell your doctor or pharmacist right away if you have||
0007|058|H|withdrawal.||
0007|059|H|   Tell your doctor if your condition does not get better or if||
0007|060|H|it gets worse.||
0007|061|B|||
0007|062|S|SIDE EFFECTS:  Nausea, vomiting, dizziness, drowsiness,||
0007|063|S|lightheadedness, tiredness, constipation, or headache may occur.||
0007|064|S|If any of these effects last or get worse, tell your doctor or||
0007|065|S|pharmacist promptly.||
0007|066|S|   Remember that this medication has been prescribed because your||
0007|067|S|doctor has judged that the benefit to you is greater than the||
0007|068|S|risk of side effects. Many people using this medication do not||
0007|069|S|have serious side effects.||
0007|070|S|   Some people taking bromocriptine have fallen asleep suddenly||
0007|071|S|during their usual daily activities (such as talking on the||
0007|072|S|phone, driving). In some cases, sleep occurred without any||
0007|073|S|feelings of drowsiness beforehand. This sleep effect may occur||
0007|074|S|anytime during treatment with bromocriptine even if you have used||
0007|075|S|this medication for a long time. If you experience increased||
0007|076|S|sleepiness or fall asleep during the day, do not drive or take||
0007|077|S|part in other possibly dangerous activities until you have||
0007|078|S|discussed this effect with your doctor. Your risk of this sleep||
0007|079|S|effect is increased by using alcohol or other medications that||
0007|080|S|can make you drowsy. See also Precautions section.||
0007|081|S|   This medication may increase or decrease your blood pressure.||
0007|082|S|Monitor your blood pressure as directed by your doctor. A||
0007|083|S|decrease in blood pressure usually occurs when you are first||
0007|084|S|starting the medication, when your dose is increased, or when you||
0007|085|S|get up suddenly. This effect can cause dizziness,||
0007|086|S|lightheadedness, and fainting. To reduce the risk of dizziness||
0007|087|S|and lightheadedness, get up slowly when rising from a sitting or||
0007|088|S|lying position.||
0007|089|S|   Tell your doctor right away if you have any serious side||
0007|090|S|effects, including: runny nose that doesn't go away, back pain,||
0007|091|S|swelling of the legs/ankles/feet, signs of kidney problems (such||
0007|092|S|as change in the amount of urine), severe stomach/abdominal pain,||
0007|093|S|black/bloody stools, vomit that looks like coffee grounds, cold||
0007|094|S|or slightly blue fingers/toes, tingling/numbness of hands/feet,||
0007|095|S|mental/mood changes (such as confusion, agitation,||
0007|096|S|hallucinations), unusual strong urges (such as increased||
0007|097|S|gambling, increased sexual urges), slow/fast/irregular heartbeat.||
0007|098|S|   Get medical help right away if you have any very serious side||
0007|099|S|effects, including: headache that is severe or doesn't go away,||
0007|100|S|seizure, trouble speaking, weakness on one side of the body,||
0007|101|S|vision changes (such as decreased/blurred vision), chest/jaw/left||
0007|102|S|arm pain, trouble breathing.||
0007|103|S|   A very serious allergic reaction to this drug is rare.||
0007|104|S|However, get medical help right away if you notice any symptoms||
0007|105|S|of a serious allergic reaction, including: rash, itching/swelling||
0007|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0007|107|S|breathing.||
0007|108|S|   This is not a complete list of possible side effects. If you||
0007|109|S|notice other effects not listed above, contact your doctor or||
0007|110|S|pharmacist.||
0007|111|S|   In the US -||
0007|112|S|   Call your doctor for medical advice about side effects. You||
0007|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0007|114|S|www.fda.gov/medwatch.||
0007|115|S|   In Canada - Call your doctor for medical advice about side||
0007|116|S|effects. You may report side effects to Health Canada at||
0007|117|S|1-866-234-2345.||
0007|118|B|||
0007|119|P|PRECAUTIONS:  Before taking bromocriptine, tell your doctor or||
0007|120|P|pharmacist if you are allergic to it; or to other ergot||
0007|121|P|medications (such as ergotamine, pergolide); or if you have any||
0007|122|P|other allergies. This product may contain inactive ingredients,||
0007|123|P|which can cause allergic reactions or other problems. Talk to||
0007|124|P|your pharmacist for more details.||
0007|125|P|   Before using this medication, tell your doctor or pharmacist||
0007|126|P|your medical history, especially of: certain genetic enzyme||
0007|127|P|problems (galactose intolerance, lactase deficiency,||
0007|128|P|glucose-galactose malabsorption), high or low blood pressure,||
0007|129|P|liver disease, heart problems (such as coronary artery disease,||
0007|130|P|heart attack, irregular heartbeat), mental/mood disorders (such||
0007|131|P|as psychosis, depression, schizophrenia), stomach/intestinal||
0007|132|P|problems (such as bleeding, ulcer), blood flow problems (such as||
0007|133|P|peripheral vascular disease, Raynaud's disease), recent pregnancy||
0007|134|P|(especially with high blood pressure).||
0007|135|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0007|136|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0007|137|P|machinery, or do anything that needs alertness until you can do||
0007|138|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0007|139|P|are using marijuana (cannabis). See also Side Effects section.||
0007|140|P|   Bromocriptine can reduce blood flow in the fingers and toes,||
0007|141|P|especially during exposure to cold, increasing the risk of damage||
0007|142|P|(such as frostbite). Keep hands and feet warm during cold||
0007|143|P|weather.||
0007|144|P|   Before having surgery, tell your doctor or dentist about all||
0007|145|P|the products you use (including prescription drugs,||
0007|146|P|nonprescription drugs, and herbal products).||
0007|147|P|   During pregnancy, this medication should be used only when||
0007|148|P|clearly needed. Discuss the risks and benefits with your doctor.||
0007|149|P|This medication should not be used in women who have recently||
0007|150|P|given birth due to risk of serious side effects.||
0007|151|P|   Since this medication may restore fertility in women with high||
0007|152|P|prolactin or growth hormone levels, women who do not want to||
0007|153|P|become pregnant should discuss with their doctor the use of||
0007|154|P|non-hormonal birth control methods (such as condoms, diaphragm)||
0007|155|P|while taking this medication. Talk to your doctor for more||
0007|156|P|details.||
0007|157|P|   It is unknown if this medication passes into breast milk.||
0007|158|P|Breastfeeding is not recommended while using this drug. Consult||
0007|159|P|your doctor before breastfeeding.||
0007|160|B|||
0007|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0007|162|I|medications work or increase your risk for serious side effects.||
0007|163|I|This document does not contain all possible drug interactions.||
0007|164|I|Keep a list of all the products you use (including||
0007|165|I|prescription/nonprescription drugs and herbal products) and share||
0007|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
0007|167|I|the dosage of any medicines without your doctor's approval.||
0007|168|I|   Some products that may interact with this drug include: other||
0007|169|I|ergot medications (such as ergotamine).||
0007|170|I|   Other medications can affect the removal of bromocriptine from||
0007|171|I|your body, which may affect how bromocriptine works. Examples||
0007|172|I|include azole antifungals (such as itraconazole, ketoconazole),||
0007|173|I|cobicistat, macrolide antibiotics (such as clarithromycin,||
0007|174|I|erythromycin), nefazodone, HIV protease inhibitors (such as||
0007|175|I|lopinavir), ritonavir, telithromycin, among others.||
0007|176|I|   Tell your doctor or pharmacist if you are taking other||
0007|177|I|products that cause drowsiness including alcohol, marijuana||
0007|178|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0007|179|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0007|180|I|zolpidem), muscle relaxants (such as carisoprodol,||
0007|181|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
0007|182|I|hydrocodone).||
0007|183|I|   Check the labels on all your medicines (such as allergy or||
0007|184|I|cough-and-cold products) because they may contain ingredients||
0007|185|I|that cause drowsiness. Ask your pharmacist about using those||
0007|186|I|products safely.||
0007|187|B|||
0007|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0007|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0007|190|O|poison control center right away. US residents can call||
0007|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0007|192|O|Symptoms of overdose may include: mental/mood changes (such as||
0007|193|O|hallucinations, agitation, confusion), severe dizziness,||
0007|194|O|fainting.||
0007|195|B|||
0007|196|N|NOTES:  Do not share this medication with others.||
0007|197|N|   Lab and/or medical tests (such as blood pressure, kidney/liver||
0007|198|N|function, eye exams, complete blood count) should be done while||
0007|199|N|you are taking this medication. Keep all medical and lab||
0007|200|N|appointments. Consult your doctor for more details.||
0007|201|B|||
0007|202|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0007|203|D|remember. If it is near the time of the next dose, skip the||
0007|204|D|missed dose. Take your next dose at the regular time. Do not||
0007|205|D|double the dose to catch up.||
0007|206|B|||
0007|207|R|STORAGE:  Store at room temperature away from light and moisture.||
0007|208|R|Do not store in the bathroom. Keep all medications away from||
0007|209|R|children and pets.||
0007|210|R|   Do not flush medications down the toilet or pour them into a||
0007|211|R|drain unless instructed to do so. Properly discard this product||
0007|212|R|when it is expired or no longer needed. Consult your pharmacist||
0007|213|R|or local waste disposal company.||
0007|214|B|||
0007|215|A|Information last revised November 2025.||
0007|216|A|Copyright(c) 2025 First Databank, Inc.||
0007|217|B|||
0009|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0009|002|Z|does NOT have all possible information about this product. This||
0009|003|Z|information does not assure that this product is safe, effective,||
0009|004|Z|or appropriate for you. This information is not individual||
0009|005|Z|medical advice and does not substitute for the advice of your||
0009|006|Z|health care professional. Always ask your health care||
0009|007|Z|professional for complete information about this product and your||
0009|008|Z|specific health needs.||
0009|009|B|||
0009|010|T|ACETAMINOPHEN - ORAL||
0009|011|F|(a-SEET-a-MIN-oh-fen)||
0009|012|B|||
0009|013|C|COMMON BRAND NAME(S): Panadol, Tylenol||
0009|014|B|||
0009|015|W|WARNING:  Taking too much acetaminophen may cause serious||
0009|016|W|(possibly fatal) liver disease. Adults should not take more than||
0009|017|W|4000 milligrams (4 grams) of acetaminophen a day. People with||
0009|018|W|liver problems and children should take less acetaminophen. Ask||
0009|019|W|your doctor or pharmacist how much acetaminophen is safe to take.||
0009|020|W|   Do not use with any other drug containing acetaminophen||
0009|021|W|without asking your doctor or pharmacist first. Acetaminophen is||
0009|022|W|in many nonprescription and prescription medications (such as||
0009|023|W|pain/fever drugs or cough-and-cold products). Check the labels on||
0009|024|W|all your medicines to see if they contain acetaminophen, and ask||
0009|025|W|your pharmacist if you are unsure.||
0009|026|W|   Get medical help right away if you take too much acetaminophen||
0009|027|W|(overdose), even if you feel well. Overdose symptoms may include||
0009|028|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
0009|029|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
0009|030|W|   Daily alcohol use, especially when combined with||
0009|031|W|acetaminophen, may damage your liver. Avoid alcohol.||
0009|032|B|||
0009|033|U|USES:  This drug is used to treat mild to moderate pain (from||
0009|034|U|headaches, menstrual periods, toothaches, backaches,||
0009|035|U|osteoarthritis, or cold/flu aches and pains) and to reduce fever.||
0009|036|B|||
0009|037|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
0009|038|H|directions on the product package. If you have any questions, ask||
0009|039|H|your doctor or pharmacist.||
0009|040|H|   There are many brands and forms of acetaminophen available.||
0009|041|H|Read the dosing instructions carefully for each product because||
0009|042|H|the amount of acetaminophen may be different between products. Do||
0009|043|H|not take more acetaminophen than recommended. (See also Warning||
0009|044|H|section.)||
0009|045|H|   If you are giving acetaminophen to a child, be sure you use a||
0009|046|H|product that is meant for children. Use your child's weight to||
0009|047|H|find the right dose on the product package. If you don't know||
0009|048|H|your child's weight, you can use their age.||
0009|049|H|   For suspensions, shake the medication well before each dose.||
0009|050|H|Some liquids do not need to be shaken before use. Follow all||
0009|051|H|directions on the product package. Measure the liquid medication||
0009|052|H|with the provided dose-measuring spoon/dropper/syringe to make||
0009|053|H|sure you have the correct dose. Do not use a household spoon.||
0009|054|H|   For rapidly-dissolving tablets, chew or allow to dissolve on||
0009|055|H|the tongue, then swallow with or without water. For chewable||
0009|056|H|tablets, chew thoroughly before swallowing.||
0009|057|H|   Do not crush or chew extended-release tablets. Doing so can||
0009|058|H|release all of the drug at once, increasing the risk of side||
0009|059|H|effects. Swallow the tablets whole.||
0009|060|H|   For effervescent tablets, dissolve the dose in the recommended||
0009|061|H|amount of water, then drink.||
0009|062|H|   Pain medications work best if they are used as the first signs||
0009|063|H|of pain occur. If you wait until the symptoms have worsened, the||
0009|064|H|medication may not work as well.||
0009|065|H|   Do not take this medication for fever for more than 3 days||
0009|066|H|unless directed by your doctor. For adults, do not take this||
0009|067|H|product for pain for more than 10 days (5 days in children)||
0009|068|H|unless directed by your doctor. If the child has a sore throat||
0009|069|H|(especially with high fever, headache, or nausea/vomiting),||
0009|070|H|consult the doctor promptly.||
0009|071|H|   Tell your doctor if your condition lasts or gets worse or if||
0009|072|H|you develop new symptoms. If you think you may have a serious||
0009|073|H|medical problem, get medical help right away.||
0009|074|B|||
0009|075|S|SIDE EFFECTS:  See also Warning section.||
0009|076|S|   This drug usually has no side effects. If you have any unusual||
0009|077|S|effects, contact your doctor or pharmacist promptly.||
0009|078|S|   If your doctor has directed you to use this medication,||
0009|079|S|remember that your doctor has judged that the benefit to you is||
0009|080|S|greater than the risk of side effects. Many people using this||
0009|081|S|medication do not have serious side effects.||
0009|082|S|   A very serious allergic reaction to this drug is rare.||
0009|083|S|However, get medical help right away if you notice any symptoms||
0009|084|S|of a serious allergic reaction, including: rash, itching/swelling||
0009|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0009|086|S|breathing.||
0009|087|S|   This is not a complete list of possible side effects. If you||
0009|088|S|notice other effects not listed above, contact your doctor or||
0009|089|S|pharmacist.||
0009|090|S|   In the US -||
0009|091|S|   Call your doctor for medical advice about side effects. You||
0009|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0009|093|S|www.fda.gov/medwatch.||
0009|094|S|   In Canada - Call your doctor for medical advice about side||
0009|095|S|effects. You may report side effects to Health Canada at||
0009|096|S|1-866-234-2345.||
0009|097|B|||
0009|098|P|PRECAUTIONS:  See also Warning section.||
0009|099|P|   Before taking acetaminophen, tell your doctor or pharmacist if||
0009|100|P|you are allergic to it; or if you have any other allergies. This||
0009|101|P|product may contain inactive ingredients, which can cause||
0009|102|P|allergic reactions or other problems. Talk to your pharmacist for||
0009|103|P|more details.||
0009|104|P|   Before using this product, tell your doctor or pharmacist your||
0009|105|P|medical history, especially of: liver disease, regular use/abuse||
0009|106|P|of alcohol.||
0009|107|P|   Liquid products, chewable tablets, or dissolving/effervescent||
0009|108|P|tablets and powders may contain sugar or aspartame. Caution is||
0009|109|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
0009|110|P|condition that requires you to limit/avoid these substances in||
0009|111|P|your diet. If you have any of these conditions, ask your doctor||
0009|112|P|or pharmacist about using these products safely.||
0009|113|P|   Tell your doctor if you are pregnant before using this||
0009|114|P|medication.||
0009|115|P|   Acetaminophen passes into breast milk. Consult your doctor||
0009|116|P|before breastfeeding.||
0009|117|B|||
0009|118|I|DRUG INTERACTIONS:  See also Warning section.||
0009|119|I|   Drug interactions may change how your medications work or||
0009|120|I|increase your risk for serious side effects. This document does||
0009|121|I|not contain all possible drug interactions. Keep a list of all||
0009|122|I|the products you use (including prescription/nonprescription||
0009|123|I|drugs and herbal products) and share it with your doctor and||
0009|124|I|pharmacist. Do not start, stop, or change the dosage of any||
0009|125|I|medicines without your doctor's approval.||
0009|126|I|   Some products that may interact with this drug are:||
0009|127|I|ketoconazole, levoketoconazole.||
0009|128|I|   This medication may interfere with certain lab tests, possibly||
0009|129|I|causing false test results. Make sure lab personnel and all your||
0009|130|I|doctors know you use this drug.||
0009|131|B|||
0009|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0009|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0009|134|O|poison control center right away. US residents can call||
0009|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0009|136|O|Symptoms of overdose may include: nausea, vomiting, loss of||
0009|137|O|appetite, sweating, stomach/abdominal pain, extreme tiredness,||
0009|138|O|yellowing eyes/skin, dark urine.||
0009|139|B|||
0009|140|N|NOTES:  Acetaminophen does not cause the stomach and intestinal||
0009|141|N|ulcers that NSAIDs such as aspirin, ibuprofen, and naproxen may||
0009|142|N|cause. However, acetaminophen does not reduce swelling||
0009|143|N|(inflammation) like the NSAIDs do. Consult your doctor for more||
0009|144|N|details and to see which medication might be right for you.||
0009|145|B|||
0009|146|D|MISSED DOSE:  If you are taking this medication on a regular||
0009|147|D|schedule and miss a dose, take it as soon as you remember. If it||
0009|148|D|is near the time of the next dose, skip the missed dose. Take||
0009|149|D|your next dose at the regular time. Do not double the dose to||
0009|150|D|catch up.||
0009|151|B|||
0009|152|R|STORAGE:  Store at room temperature away from light and moisture.||
0009|153|R|Do not store in the bathroom. Keep all medications away from||
0009|154|R|children and pets.||
0009|155|R|   Do not flush medications down the toilet or pour them into a||
0009|156|R|drain unless instructed to do so. Properly discard this product||
0009|157|R|when it is expired or no longer needed. Consult your pharmacist||
0009|158|R|or local waste disposal company.||
0009|159|B|||
0009|160|A|Information last revised May 2024.||
0009|161|A|Copyright(c) 2025 First Databank, Inc.||
0009|162|B|||
0010|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0010|002|Z|does NOT have all possible information about this product. This||
0010|003|Z|information does not assure that this product is safe, effective,||
0010|004|Z|or appropriate for you. This information is not individual||
0010|005|Z|medical advice and does not substitute for the advice of your||
0010|006|Z|health care professional. Always ask your health care||
0010|007|Z|professional for complete information about this product and your||
0010|008|Z|specific health needs.||
0010|009|B|||
0010|010|T|NIFEDIPINE - ORAL||
0010|011|F|(nye-FED-i-peen)||
0010|012|B|||
0010|013|C|COMMON BRAND NAME(S): Procardia||
0010|014|B|||
0010|015|U|USES:  This medication is used to prevent certain types of chest||
0010|016|U|pain (angina). It may allow you to exercise more and decrease the||
0010|017|U|frequency of angina attacks. Nifedipine belongs to a class of||
0010|018|U|medications known as calcium channel blockers. It works by||
0010|019|U|relaxing blood vessels so blood can flow more easily. This||
0010|020|U|medication must be taken regularly to be effective. It should not||
0010|021|U|be used to treat attacks of chest pain when they occur. Use other||
0010|022|U|medications (such as sublingual nitroglycerin) to relieve attacks||
0010|023|U|of chest pain as directed by your doctor. Consult your doctor or||
0010|024|U|pharmacist for details.||
0010|025|U|   Older adults should discuss the risks and benefits of this||
0010|026|U|medication with their doctor or pharmacist, as well as other||
0010|027|U|possibly safer forms of nifedipine (such as the long-acting||
0010|028|U|tablets).||
0010|029|B|||
0010|030|V|OTHER USES:  This section contains uses of this drug that are not||
0010|031|V|listed in the approved professional labeling for the drug but||
0010|032|V|that may be prescribed by your health care professional. Use this||
0010|033|V|drug for a condition that is listed in this section only if it||
0010|034|V|has been so prescribed by your health care professional.||
0010|035|V|   This drug may also be used for a certain blood circulation||
0010|036|V|disorder (Raynaud's syndrome).||
0010|037|B|||
0010|038|H|HOW TO USE:  Take this medication by mouth with or without food||
0010|039|H|as directed by your doctor, usually 3 times daily. Swallow this||
0010|040|H|medication whole. Do not crush, chew, or break the capsule.||
0010|041|H|   The dosage is based on your medical condition and response to||
0010|042|H|treatment. Your doctor may gradually increase your dose. Follow||
0010|043|H|your doctor's instructions carefully.||
0010|044|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0010|045|H|using this medication unless your doctor or pharmacist says you||
0010|046|H|may do so safely. Grapefruit can increase the chance of side||
0010|047|H|effects with this medicine. Ask your doctor or pharmacist for||
0010|048|H|more details.||
0010|049|H|   Use this medication regularly to get the most benefit from it.||
0010|050|H|To help you remember, take it at the same times each day.||
0010|051|H|   Tell your doctor if your condition gets worse (for example,||
0010|052|H|your chest pain worsens or is more frequent).||
0010|053|B|||
0010|054|S|SIDE EFFECTS:  Dizziness, flushing, weakness, swelling||
0010|055|S|ankles/feet, constipation, and headache may occur. If any of||
0010|056|S|these effects last or get worse, tell your doctor or pharmacist||
0010|057|S|promptly.||
0010|058|S|   To reduce the risk of dizziness and lightheadedness, get up||
0010|059|S|slowly when rising from a sitting or lying position.||
0010|060|S|   Remember that this medication has been prescribed because your||
0010|061|S|doctor has judged that the benefit to you is greater than the||
0010|062|S|risk of side effects. Many people using this medication do not||
0010|063|S|have serious side effects.||
0010|064|S|   Tell your doctor right away if you have any serious side||
0010|065|S|effects, including: fast/irregular/pounding heartbeat, fainting,||
0010|066|S|vision changes.||
0010|067|S|   Although this medication is effective in preventing chest pain||
0010|068|S|(angina), some people who already have severe heart disease may||
0010|069|S|rarely develop worsening chest pain or a heart attack after||
0010|070|S|starting this medication or increasing the dose. Get medical help||
0010|071|S|right away if you experience: worsening chest pain, symptoms of a||
0010|072|S|heart attack (such as chest/jaw/left arm pain, shortness of||
0010|073|S|breath, unusual sweating).||
0010|074|S|   A very serious allergic reaction to this drug is rare.||
0010|075|S|However, get medical help right away if you notice any symptoms||
0010|076|S|of a serious allergic reaction, including: rash, itching/swelling||
0010|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0010|078|S|breathing.||
0010|079|S|   This is not a complete list of possible side effects. If you||
0010|080|S|notice other effects not listed above, contact your doctor or||
0010|081|S|pharmacist.||
0010|082|S|   In the US -||
0010|083|S|   Call your doctor for medical advice about side effects. You||
0010|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0010|085|S|www.fda.gov/medwatch.||
0010|086|S|   In Canada - Call your doctor for medical advice about side||
0010|087|S|effects. You may report side effects to Health Canada at||
0010|088|S|1-866-234-2345.||
0010|089|B|||
0010|090|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0010|091|P|pharmacist if you are allergic to it; or if you have any other||
0010|092|P|allergies. This product may contain inactive ingredients, which||
0010|093|P|can cause allergic reactions or other problems. Talk to your||
0010|094|P|pharmacist for more details.||
0010|095|P|   Before using this medication, tell your doctor or pharmacist||
0010|096|P|your medical history, especially of: certain heart problems (such||
0010|097|P|as heart failure, aortic stenosis), liver problems, kidney||
0010|098|P|problems.||
0010|099|P|   Before having surgery, tell your doctor or dentist about all||
0010|100|P|the products you use (including prescription drugs,||
0010|101|P|nonprescription drugs, and herbal products).||
0010|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0010|103|P|can make you more dizzy. Do not drive, use machinery, or do||
0010|104|P|anything that needs alertness until you can do it safely. Limit||
0010|105|P|alcoholic beverages. Talk to your doctor if you are using||
0010|106|P|marijuana (cannabis).||
0010|107|P|   Older adults may be more sensitive to the side effects of this||
0010|108|P|drug, especially dizziness, constipation, or swelling||
0010|109|P|ankles/feet.||
0010|110|P|   During pregnancy, this medication should be used only when||
0010|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
0010|112|P|   This medication passes into breast milk. Consult your doctor||
0010|113|P|before breastfeeding.||
0010|114|B|||
0010|115|I|DRUG INTERACTIONS:  See also the How to Use section.||
0010|116|I|   Drug interactions may change how your medications work or||
0010|117|I|increase your risk for serious side effects. This document does||
0010|118|I|not contain all possible drug interactions. Keep a list of all||
0010|119|I|the products you use (including prescription/nonprescription||
0010|120|I|drugs and herbal products) and share it with your doctor and||
0010|121|I|pharmacist. Do not start, stop, or change the dosage of any||
0010|122|I|medicines without your doctor's approval.||
0010|123|I|   Other medications can affect the removal of nifedipine from||
0010|124|I|your body, which may affect how nifedipine works. Examples||
0010|125|I|include apalutamide, enzalutamide, mitotane, St. John's wort,||
0010|126|I|rifamycins (such as rifabutin, rifampin), drugs used to treat||
0010|127|I|seizures (such as carbamazepine, phenobarbital, phenytoin), among||
0010|128|I|others.||
0010|129|I|   Some products have ingredients that could raise your heart||
0010|130|I|rate or worsen your chest pain. Tell your pharmacist what||
0010|131|I|products you are using, and ask how to use them safely||
0010|132|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0010|133|I|ibuprofen/naproxen).||
0010|134|B|||
0010|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0010|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0010|137|O|poison control center right away. US residents can call||
0010|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0010|139|B|||
0010|140|N|NOTES:  Do not share this medication with others.||
0010|141|N|   Lab and/or medical tests (such as blood pressure, liver/kidney||
0010|142|N|function, electrocardiogram) may be done while you are taking||
0010|143|N|this medication. Keep all medical and lab appointments. Consult||
0010|144|N|your doctor for more details.||
0010|145|B|||
0010|146|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0010|147|D|remember. If it is near the time of the next dose, skip the||
0010|148|D|missed dose. Take your next dose at the regular time. Do not||
0010|149|D|double the dose to catch up.||
0010|150|B|||
0010|151|R|STORAGE:  Store at room temperature away from light and moisture.||
0010|152|R|Do not store in the bathroom. Keep all medications away from||
0010|153|R|children and pets.||
0010|154|R|   Do not flush medications down the toilet or pour them into a||
0010|155|R|drain unless instructed to do so. Properly discard this product||
0010|156|R|when it is expired or no longer needed. Consult your pharmacist||
0010|157|R|or local waste disposal company.||
0010|158|B|||
0010|159|M|MEDICAL ALERT:  Your condition can cause complications in a||
0010|160|M|medical emergency. For information about enrolling in MedicAlert,||
0010|161|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0010|162|B|||
0010|163|A|Information last revised February 2025.||
0010|164|A|Copyright(c) 2025 First Databank, Inc.||
0010|165|B|||
0011|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0011|002|Z|does NOT have all possible information about this product. This||
0011|003|Z|information does not assure that this product is safe, effective,||
0011|004|Z|or appropriate for you. This information is not individual||
0011|005|Z|medical advice and does not substitute for the advice of your||
0011|006|Z|health care professional. Always ask your health care||
0011|007|Z|professional for complete information about this product and your||
0011|008|Z|specific health needs.||
0011|009|B|||
0011|010|T|CEPHALEXIN - ORAL||
0011|011|F|(SEF-a-LEX-in)||
0011|012|B|||
0011|013|C|COMMON BRAND NAME(S): Keflex||
0011|014|B|||
0011|015|U|USES:  This medication is used to treat a wide variety of||
0011|016|U|bacterial infections. This medication is known as a cephalosporin||
0011|017|U|antibiotic. It works by stopping the growth of bacteria.||
0011|018|U|   This medication will not work for viral infections (such as||
0011|019|U|common cold, flu). Unnecessary use or misuse of any antibiotic||
0011|020|U|can lead to its decreased effectiveness.||
0011|021|B|||
0011|022|V|OTHER USES:  This section contains uses of this drug that are not||
0011|023|V|listed in the approved professional labeling for the drug but||
0011|024|V|that may be prescribed by your health care professional. Use this||
0011|025|V|drug for a condition that is listed in this section only if it||
0011|026|V|has been so prescribed by your health care professional.||
0011|027|V|   This drug may also be used before dental procedures in people||
0011|028|V|with certain heart conditions (such as artificial heart valves)||
0011|029|V|to reduce the risk of a serious infection of the heart (bacterial||
0011|030|V|endocarditis).||
0011|031|B|||
0011|032|H|HOW TO USE:  Take this medication by mouth as directed by your||
0011|033|H|doctor, usually every 6 to 12 hours with or without food.||
0011|034|H|   If you are using the suspension, shake the bottle well before||
0011|035|H|each dose. Measure the dose carefully using a special measuring||
0011|036|H|device/spoon. Do not use a household spoon because you may not||
0011|037|H|get the correct dose.||
0011|038|H|   The dosage is based on your medical condition and response to||
0011|039|H|treatment. Children's dosage is also based on weight.||
0011|040|H|   For the best effect, take this antibiotic at evenly spaced||
0011|041|H|times. To help you remember, take this medication at the same||
0011|042|H|time(s) every day.||
0011|043|H|   Continue to take this medication until the full prescribed||
0011|044|H|amount is finished, even if symptoms disappear after a few days.||
0011|045|H|Stopping the medication too early may result in a return of the||
0011|046|H|infection.||
0011|047|H|   Tell your doctor if your condition lasts or gets worse.||
0011|048|B|||
0011|049|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, or upset stomach may||
0011|050|S|occur. If any of these effects last or get worse, tell your||
0011|051|S|doctor or pharmacist promptly.||
0011|052|S|   Remember that this medication has been prescribed because your||
0011|053|S|doctor has judged that the benefit to you is greater than the||
0011|054|S|risk of side effects. Many people using this medication do not||
0011|055|S|have serious side effects.||
0011|056|S|   Use of this medication for prolonged or repeated periods may||
0011|057|S|result in oral thrush or a new yeast infection. Contact your||
0011|058|S|doctor if you notice white patches in your mouth, a change in||
0011|059|S|vaginal discharge, or other new symptoms.||
0011|060|S|   This medication may rarely cause a severe intestinal condition||
0011|061|S|due to a bacteria called C. difficile. This condition may occur||
0011|062|S|during treatment or weeks to months after treatment has stopped.||
0011|063|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0011|064|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0011|065|S|stool.||
0011|066|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0011|067|S|products because they may make symptoms worse.||
0011|068|S|   A very serious allergic reaction to this drug is rare.||
0011|069|S|However, get medical help right away if you notice any symptoms||
0011|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0011|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0011|072|S|breathing.||
0011|073|S|   This is not a complete list of possible side effects. If you||
0011|074|S|notice other effects not listed above, contact your doctor or||
0011|075|S|pharmacist.||
0011|076|S|   In the US -||
0011|077|S|   Call your doctor for medical advice about side effects. You||
0011|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0011|079|S|www.fda.gov/medwatch.||
0011|080|S|   In Canada - Call your doctor for medical advice about side||
0011|081|S|effects. You may report side effects to Health Canada at||
0011|082|S|1-866-234-2345.||
0011|083|B|||
0011|084|P|PRECAUTIONS:  Before taking cephalexin, tell your doctor or||
0011|085|P|pharmacist if you are allergic to it; or to penicillins or other||
0011|086|P|cephalosporins (such as cefpodoxime); or if you have any other||
0011|087|P|allergies. This product may contain inactive ingredients, which||
0011|088|P|can cause allergic reactions or other problems. Talk to your||
0011|089|P|pharmacist for more details.||
0011|090|P|   Before using this medication, tell your doctor or pharmacist||
0011|091|P|your medical history, especially of: kidney disease,||
0011|092|P|stomach/intestinal disease (such as colitis).||
0011|093|P|   The liquid form of this product may contain sugar. Caution is||
0011|094|P|advised if you have diabetes. Ask your doctor or pharmacist about||
0011|095|P|using this product safely.||
0011|096|P|   Cephalexin may cause live bacterial vaccines (such as typhoid||
0011|097|P|vaccine) to not work well. Tell your health care professional||
0011|098|P|that you are using cephalexin before having any||
0011|099|P|immunizations/vaccinations.||
0011|100|P|   Before having surgery, tell your doctor or dentist about all||
0011|101|P|the products you use (including prescription drugs,||
0011|102|P|nonprescription drugs, and herbal products).||
0011|103|P|   During pregnancy, this medication should be used only when||
0011|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
0011|105|P|   This medication passes into breast milk. Consult your doctor||
0011|106|P|before breastfeeding.||
0011|107|B|||
0011|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0011|109|I|medications work or increase your risk for serious side effects.||
0011|110|I|This document does not contain all possible drug interactions.||
0011|111|I|Keep a list of all the products you use (including||
0011|112|I|prescription/nonprescription drugs and herbal products) and share||
0011|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
0011|114|I|the dosage of any medicines without your doctor's approval.||
0011|115|I|   A product that may interact with this drug is: dofetilide.||
0011|116|I|   This medication may interfere with certain lab tests||
0011|117|I|(including Coombs' test, certain urine glucose tests), possibly||
0011|118|I|causing false test results. Make sure lab personnel and all your||
0011|119|I|doctors know you use this drug.||
0011|120|B|||
0011|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0011|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0011|123|O|poison control center right away. US residents can call||
0011|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0011|125|O|Symptoms of overdose may include: vomiting that is severe or||
0011|126|O|doesn't stop, blood in the urine, seizures.||
0011|127|B|||
0011|128|N|NOTES:  Do not share this medication with others.||
0011|129|N|   This medication has been prescribed for your current condition||
0011|130|N|only. Do not use it later for another infection unless your||
0011|131|N|doctor tells you to.||
0011|132|N|   Lab and/or medical tests (such as kidney function, cultures)||
0011|133|N|may be done while you are taking this medication. Keep all||
0011|134|N|medical and lab appointments. Consult your doctor for more||
0011|135|N|details.||
0011|136|B|||
0011|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0011|138|D|remember. If it is near the time of the next dose, skip the||
0011|139|D|missed dose. Take your next dose at the regular time. Do not||
0011|140|D|double the dose to catch up.||
0011|141|B|||
0011|142|R|STORAGE:  Store the capsules and tablets at room temperature away||
0011|143|R|from light and moisture. Do not store in the bathroom. Store the||
0011|144|R|suspension in the refrigerator. Do not freeze. Discard any unused||
0011|145|R|suspension after 14 days. Keep all medications away from children||
0011|146|R|and pets.||
0011|147|R|   Do not flush medications down the toilet or pour them into a||
0011|148|R|drain unless instructed to do so. Properly discard this product||
0011|149|R|when it is expired or no longer needed. Consult your pharmacist||
0011|150|R|or local waste disposal company.||
0011|151|B|||
0011|152|A|Information last revised September 2024.||
0011|153|A|Copyright(c) 2025 First Databank, Inc.||
0011|154|B|||
0012|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0012|002|Z|does NOT have all possible information about this product. This||
0012|003|Z|information does not assure that this product is safe, effective,||
0012|004|Z|or appropriate for you. This information is not individual||
0012|005|Z|medical advice and does not substitute for the advice of your||
0012|006|Z|health care professional. Always ask your health care||
0012|007|Z|professional for complete information about this product and your||
0012|008|Z|specific health needs.||
0012|009|B|||
0012|010|T|TRIMEPRAZINE - ORAL||
0012|011|F|(trye-MEP-ra-zeen)||
0012|012|B|||
0012|013|U|USES:  Trimeprazine is an antihistamine used to reduce itching||
0012|014|U|from allergies, hives, eczema, and other causes (such as insect||
0012|015|U|bites, chickenpox, reactions to certain drugs). It may also be||
0012|016|U|used to treat cough from various causes (such as throat||
0012|017|U|irritation, asthma, allergy, hay fever). This medication works by||
0012|018|U|blocking certain natural substances (histamine, acetylcholine)||
0012|019|U|that your body makes. To reduce itching and cough, it may also||
0012|020|U|act directly on certain parts of the brain.||
0012|021|U|   This medication should not be used by children younger than 2||
0012|022|U|years due to an increased risk of side effects.||
0012|023|B|||
0012|024|H|HOW TO USE:  Take this medication by mouth as directed by your||
0012|025|H|doctor, usually twice a day after meals and at bedtime. This||
0012|026|H|medication may also sometimes be taken only at bedtime.||
0012|027|H|   The dosage is based on your age, medical condition, and||
0012|028|H|response to treatment. Do not increase your dose or take this||
0012|029|H|medication more often without your doctor's approval. Take this||
0012|030|H|medication regularly in order to get the most benefit from it. To||
0012|031|H|help you remember, take it at the same time(s) each day.||
0012|032|H|   Tell your doctor if your condition lasts or gets worse.||
0012|033|B|||
0012|034|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, stomach upset,||
0012|035|S|blurred vision, decreased coordination, or dry mouth/nose/throat||
0012|036|S|may occur. These effects may decrease as your body adjusts to the||
0012|037|S|medication. If any of these effects last or get worse, contact||
0012|038|S|your doctor or pharmacist promptly.||
0012|039|S|   To reduce the risk of dizziness and lightheadedness, get up||
0012|040|S|slowly when rising from a sitting or lying position.||
0012|041|S|   Remember that this medication has been prescribed because your||
0012|042|S|doctor has judged that the benefit to you is greater than the||
0012|043|S|risk of side effects. Many people using this medication do not||
0012|044|S|have serious side effects.||
0012|045|S|   Tell your doctor right away if you have any serious side||
0012|046|S|effects, including: face/muscle twitching, mental/mood changes||
0012|047|S|(such as hallucinations, depression, nervousness), shaking||
0012|048|S|(tremors), trouble urinating, uncontrolled movements, easy||
0012|049|S|bruising/bleeding, fast/irregular heartbeat, seizure.||
0012|050|S|   A very serious allergic reaction to this drug is rare.||
0012|051|S|However, get medical help right away if you notice any symptoms||
0012|052|S|of a serious allergic reaction, including: rash, itching/swelling||
0012|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0012|054|S|breathing.||
0012|055|S|   This is not a complete list of possible side effects. If you||
0012|056|S|notice other effects not listed above, contact your doctor or||
0012|057|S|pharmacist.||
0012|058|S|   In the US -||
0012|059|S|   Call your doctor for medical advice about side effects. You||
0012|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0012|061|S|www.fda.gov/medwatch.||
0012|062|S|   In Canada - Call your doctor for medical advice about side||
0012|063|S|effects. You may report side effects to Health Canada at||
0012|064|S|1-866-234-2345.||
0012|065|B|||
0012|066|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0012|067|P|pharmacist if you are allergic to it; or to phenothiazines (such||
0012|068|P|as chlorpromazine); or if you have any other allergies. This||
0012|069|P|product may contain inactive ingredients, which can cause||
0012|070|P|allergic reactions or other problems. Talk to your pharmacist for||
0012|071|P|more details.||
0012|072|P|   Before using this medication, tell your doctor or pharmacist||
0012|073|P|your medical history, especially of: blood disorders (such as||
0012|074|P|bone marrow depression), breathing problems (such as asthma,||
0012|075|P|emphysema), a certain eye problem (glaucoma), heart problems,||
0012|076|P|high blood pressure, liver disease, seizures, stomach/intestinal||
0012|077|P|problems (such as ulcers, blockage), overactive thyroid||
0012|078|P|(hyperthyroidism), urination problems (such as trouble urinating||
0012|079|P|due to enlarged prostate, urinary retention).||
0012|080|P|   This drug may make you dizzy or drowsy or blur your vision.||
0012|081|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0012|082|P|drowsy. Do not drive, use machinery, or do anything that needs||
0012|083|P|alertness or clear vision until you can do it safely. Limit||
0012|084|P|alcoholic beverages. Talk to your doctor if you are using||
0012|085|P|marijuana (cannabis).||
0012|086|P|   Before having surgery, tell your doctor or dentist about all||
0012|087|P|the products you use (including prescription drugs,||
0012|088|P|nonprescription drugs, and herbal products).||
0012|089|P|   Children may be more sensitive to the side effects of this||
0012|090|P|drug. This drug can often cause excitement in young children||
0012|091|P|instead of drowsiness.||
0012|092|P|   Older adults may be more sensitive to the side effects of this||
0012|093|P|drug, especially dizziness, drowsiness, and low blood pressure.||
0012|094|P|   During pregnancy, this drug should be used only when clearly||
0012|095|P|needed. Discuss the risks and benefits with your doctor.||
0012|096|P|   This medication passes into breast milk. Consult your doctor||
0012|097|P|before breastfeeding.||
0012|098|B|||
0012|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0012|100|I|medications work or increase your risk for serious side effects.||
0012|101|I|This document does not contain all possible drug interactions.||
0012|102|I|Keep a list of all the products you use (including||
0012|103|I|prescription/nonprescription drugs and herbal products) and share||
0012|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
0012|105|I|the dosage of any medicines without your doctor's approval.||
0012|106|I|   Tell your doctor or pharmacist if you are taking other||
0012|107|I|products that cause drowsiness such as opioid pain or cough||
0012|108|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0012|109|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0012|110|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0012|111|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0012|112|I|diphenhydramine).||
0012|113|I|   Check the labels on all your medicines (such as allergy or||
0012|114|I|cough-and-cold products) because they may contain ingredients||
0012|115|I|that cause drowsiness. Ask your pharmacist about using those||
0012|116|I|products safely.||
0012|117|I|   This medication may interfere with certain lab tests (such as||
0012|118|I|allergy skin test), possibly causing false test results. Make||
0012|119|I|sure lab personnel and all your doctors know you use this drug.||
0012|120|B|||
0012|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0012|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0012|123|O|poison control center right away. US residents can call||
0012|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0012|125|O|Symptoms of overdose may include: large pupils, flushing, fever,||
0012|126|O|hallucinations, weakness, shaking (tremors), muscle twitching,||
0012|127|O|loss of consciousness, seizures. In children, excitement may||
0012|128|O|occur first, and may be followed by loss of coordination,||
0012|129|O|drowsiness, loss of consciousness, seizures.||
0012|130|B|||
0012|131|N|NOTES:  Do not share this medication with others.||
0012|132|B|||
0012|133|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0012|134|D|remember. If it is near the time of your next dose, skip the||
0012|135|D|missed dose. Take your next dose at the regular time. Do not||
0012|136|D|double the dose to catch up.||
0012|137|B|||
0012|138|R|STORAGE:  Store at room temperature away from light and moisture.||
0012|139|R|Do not store in the bathroom. Keep all medications away from||
0012|140|R|children and pets.||
0012|141|R|   Do not flush medications down the toilet or pour them into a||
0012|142|R|drain unless instructed to do so. Properly discard this product||
0012|143|R|when it is expired or no longer needed. Consult your pharmacist||
0012|144|R|or local waste disposal company.||
0012|145|B|||
0012|146|A|Information last revised May 2024.||
0012|147|A|Copyright(c) 2025 First Databank, Inc.||
0012|148|B|||
0013|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0013|002|Z|does NOT have all possible information about this product. This||
0013|003|Z|information does not assure that this product is safe, effective,||
0013|004|Z|or appropriate for you. This information is not individual||
0013|005|Z|medical advice and does not substitute for the advice of your||
0013|006|Z|health care professional. Always ask your health care||
0013|007|Z|professional for complete information about this product and your||
0013|008|Z|specific health needs.||
0013|009|B|||
0013|010|T|BETAXOLOL - ORAL||
0013|011|F|(be-TAX-oh-lol)||
0013|012|B|||
0013|013|C|COMMON BRAND NAME(S): Kerlone||
0013|014|B|||
0013|015|W|WARNING:  If you have chest pain (angina) or have heart disease||
0013|016|W|(such as coronary artery disease, ischemic heart disease, high||
0013|017|W|blood pressure), do not stop using this drug without first||
0013|018|W|consulting your doctor. Your condition may become worse when the||
0013|019|W|drug is suddenly stopped. If your doctor decides you should no||
0013|020|W|longer use this drug, you must gradually decrease your dose||
0013|021|W|according to your doctor's instructions.||
0013|022|W|   When gradually stopping this medication, it is recommended||
0013|023|W|that you temporarily limit physical activity to decrease the work||
0013|024|W|on the heart. Get medical help right away if you develop:||
0013|025|W|worsening chest pain, tightness/pressure in the chest, chest pain||
0013|026|W|spreading to the jaw/neck/arm, sweating, trouble breathing, or||
0013|027|W|fast/irregular heartbeat.||
0013|028|B|||
0013|029|U|USES:  This medication is used to treat high blood pressure.||
0013|030|U|Lowering high blood pressure helps prevent strokes, heart||
0013|031|U|attacks, and kidney problems. Betaxolol belongs to a class of||
0013|032|U|drugs known as beta blockers. It works by blocking the action of||
0013|033|U|certain natural chemicals in your body such as epinephrine that||
0013|034|U|affect the heart and blood vessels. This results in a lowering of||
0013|035|U|the heart rate and blood pressure.||
0013|036|B|||
0013|037|H|HOW TO USE:  Take this medication by mouth with or without food||
0013|038|H|as directed by your doctor, usually once daily. The dosage is||
0013|039|H|based on your medical condition and response to treatment.||
0013|040|H|   Use this medication regularly in order to get the most benefit||
0013|041|H|from it. To help you remember, take it at the same time each day.||
0013|042|H|   Keep taking this medication even if you feel well. Most people||
0013|043|H|with high blood pressure do not feel sick.||
0013|044|H|   For the treatment of high blood pressure, it may take several||
0013|045|H|months before the full benefit of this drug takes effect.||
0013|046|H|   Tell your doctor if your condition does not get better or if||
0013|047|H|it gets worse (your blood pressure readings remain high or||
0013|048|H|increase).||
0013|049|B|||
0013|050|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, and||
0013|051|S|headache may occur as your body adjusts to the medication.||
0013|052|S|Trouble sleeping, decreased sexual ability, stomach upset,||
0013|053|S|nausea, diarrhea, dry eyes, and weakness may also occur. If any||
0013|054|S|of these effects last or get worse, tell your doctor or||
0013|055|S|pharmacist promptly.||
0013|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
0013|057|S|slowly when rising from a sitting or lying position.||
0013|058|S|   This drug may reduce blood flow to your hands and feet,||
0013|059|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0013|060|S|warmly and avoid tobacco use.||
0013|061|S|   Remember that this medication has been prescribed because your||
0013|062|S|doctor has judged that the benefit to you is greater than the||
0013|063|S|risk of side effects. Many people using this medication do not||
0013|064|S|have serious side effects.||
0013|065|S|   Tell your doctor right away if you have any serious side||
0013|066|S|effects, including: new or worsening symptoms of heart failure||
0013|067|S|(such as shortness of breath, swelling ankles/feet, unusual||
0013|068|S|tiredness, unusual/sudden weight gain), very slow heartbeat,||
0013|069|S|numb/tingling skin, mental/mood changes (such as depression,||
0013|070|S|hallucinations, confusion), joint pain, vision changes, fainting,||
0013|071|S|stomach/abdominal pain, blue fingers/toes/nails, finger/toe/leg||
0013|072|S|cramps.||
0013|073|S|   A very serious allergic reaction to this drug is rare.||
0013|074|S|However, get medical help right away if you notice any symptoms||
0013|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0013|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0013|077|S|breathing.||
0013|078|S|   This is not a complete list of possible side effects. If you||
0013|079|S|notice other effects not listed above, contact your doctor or||
0013|080|S|pharmacist.||
0013|081|S|   In the US -||
0013|082|S|   Call your doctor for medical advice about side effects. You||
0013|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0013|084|S|www.fda.gov/medwatch.||
0013|085|S|   In Canada - Call your doctor for medical advice about side||
0013|086|S|effects. You may report side effects to Health Canada at||
0013|087|S|1-866-234-2345.||
0013|088|B|||
0013|089|P|PRECAUTIONS:  See also Warning section.||
0013|090|P|   Before taking betaxolol, tell your doctor or pharmacist if you||
0013|091|P|are allergic to it; or to other beta blockers (such as atenolol,||
0013|092|P|metoprolol); or if you have any other allergies. This product may||
0013|093|P|contain inactive ingredients, which can cause allergic reactions||
0013|094|P|or other problems. Talk to your pharmacist for more details.||
0013|095|P|   Before using this medication, tell your doctor or pharmacist||
0013|096|P|your medical history, especially of: certain types of heart||
0013|097|P|rhythm problems (such as a slow heartbeat, second- or||
0013|098|P|third-degree atrioventricular block), blood circulation problems||
0013|099|P|(such as Raynaud's disease, peripheral vascular disease),||
0013|100|P|breathing problems (such as asthma, chronic bronchitis,||
0013|101|P|emphysema), glaucoma, heart failure, kidney disease, liver||
0013|102|P|disease, mental/mood disorders (such as depression), a certain||
0013|103|P|muscle disease (myasthenia gravis), skin conditions (such as||
0013|104|P|psoriasis), overactive thyroid disease (hyperthyroidism), a||
0013|105|P|certain adrenal gland tumor (pheochromocytoma), serious allergic||
0013|106|P|reactions (including those needing treatment with epinephrine).||
0013|107|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0013|108|P|can make you more dizzy. Do not drive, use machinery, or do||
0013|109|P|anything that needs alertness until you can do it safely. Limit||
0013|110|P|alcoholic beverages. Talk to your doctor if you are using||
0013|111|P|marijuana (cannabis).||
0013|112|P|   Before having surgery, tell your doctor or dentist about all||
0013|113|P|the products you use (including prescription drugs,||
0013|114|P|nonprescription drugs, and herbal products).||
0013|115|P|   This product may prevent the fast/pounding heartbeat you would||
0013|116|P|usually feel when your blood sugar level falls too low||
0013|117|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0013|118|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0013|119|P|blood sugar level, such as dizziness and sweating, are not||
0013|120|P|affected by this drug.||
0013|121|P|   If you have diabetes, this product may make it harder to||
0013|122|P|control your blood sugar levels. Check your blood sugar levels||
0013|123|P|regularly as directed by your doctor. Tell your doctor right away||
0013|124|P|if you have symptoms of high blood sugar such as increased||
0013|125|P|thirst/urination. Your doctor may need to adjust your diabetes||
0013|126|P|medication, exercise program, or diet.||
0013|127|P|   Children may be at greater risk for low blood sugar||
0013|128|P|(hypoglycemia) while using this drug, especially if they are||
0013|129|P|vomiting or not eating regularly. To help prevent low blood||
0013|130|P|sugar, make sure children eat regularly. If your child cannot eat||
0013|131|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
0013|132|P|as sweating, shaking), tell the doctor right away.||
0013|133|P|   Older adults may be at greater risk for slow heartbeat while||
0013|134|P|using this drug.||
0013|135|P|   This drug should be used only if clearly needed during||
0013|136|P|pregnancy. Newborns whose mothers have taken this drug near the||
0013|137|P|date of delivery may have problems such as low blood pressure,||
0013|138|P|low heart rate and low birth weight, and may require special||
0013|139|P|medical monitoring. Discuss the risks and benefits of taking this||
0013|140|P|medication during pregnancy with your doctor.||
0013|141|P|   This medication passes into breast milk and may have||
0013|142|P|undesirable effects on a nursing infant. Consult your doctor||
0013|143|P|before breastfeeding.||
0013|144|B|||
0013|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0013|146|I|medications work or increase your risk for serious side effects.||
0013|147|I|This document does not contain all possible drug interactions.||
0013|148|I|Keep a list of all the products you use (such as||
0013|149|I|prescription/nonprescription drugs and herbal products) and share||
0013|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
0013|151|I|the dosage of any medicines without your doctor's approval.||
0013|152|I|   Some products that may interact with this drug are:||
0013|153|I|epinephrine, fingolimod.||
0013|154|I|   Some products have ingredients that could raise your blood||
0013|155|I|pressure. Tell your pharmacist what products you are using, and||
0013|156|I|ask how to use them safely (especially cough-and-cold products,||
0013|157|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0013|158|I|   This medication may interfere with glaucoma screening tests,||
0013|159|I|possibly causing false test results. Make sure your eye doctor||
0013|160|I|knows you use this drug.||
0013|161|B|||
0013|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0013|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0013|164|O|poison control center right away. US residents can call||
0013|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0013|166|O|Symptoms of overdose may include: fainting, severe weakness, very||
0013|167|O|slow heartbeat, irregular heartbeat, sudden weight gain, sudden||
0013|168|O|swelling, trouble breathing.||
0013|169|B|||
0013|170|N|NOTES:  Do not share this medication with others.||
0013|171|N|   Lifestyle changes such as starting a stress reduction program,||
0013|172|N|stopping smoking, limiting alcohol, exercising, and making diet||
0013|173|N|changes, may increase the effectiveness of this medication. Talk||
0013|174|N|to your doctor or pharmacist about lifestyle changes that might||
0013|175|N|benefit you.||
0013|176|N|   Have your blood pressure and pulse checked regularly while||
0013|177|N|taking this medication. It may be best to learn how to monitor||
0013|178|N|your own blood pressure and pulse. Discuss this with your doctor.||
0013|179|B|||
0013|180|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0013|181|D|remember. If it is near the time of the next dose, skip the||
0013|182|D|missed dose. Take your next dose at the regular time. Do not||
0013|183|D|double the dose to catch up.||
0013|184|B|||
0013|185|R|STORAGE:  Store at room temperature away from moisture and||
0013|186|R|sunlight. Do not store in the bathroom. Keep all medications away||
0013|187|R|from children and pets.||
0013|188|R|   Do not flush medications down the toilet or pour them into a||
0013|189|R|drain unless instructed to do so. Properly discard this product||
0013|190|R|when it is expired or no longer needed. Consult your pharmacist||
0013|191|R|or local waste disposal company.||
0013|192|B|||
0013|193|A|Information last revised August 2024.||
0013|194|A|Copyright(c) 2025 First Databank, Inc.||
0013|195|B|||
0015|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0015|002|Z|does NOT have all possible information about this product. This||
0015|003|Z|information does not assure that this product is safe, effective,||
0015|004|Z|or appropriate for you. This information is not individual||
0015|005|Z|medical advice and does not substitute for the advice of your||
0015|006|Z|health care professional. Always ask your health care||
0015|007|Z|professional for complete information about this product and your||
0015|008|Z|specific health needs.||
0015|009|B|||
0015|010|T|ERYTHROMYCIN - ORAL||
0015|011|F|(e-RITH-roe-MYE-sin base, e-RITH-roe-MYE-sin STEER-ate)||
0015|012|B|||
0015|013|C|COMMON BRAND NAME(S): Erythrocin||
0015|014|B|||
0015|015|U|USES:  Erythromycin is used to treat a wide variety of bacterial||
0015|016|U|infections. It may also be used to prevent certain bacterial||
0015|017|U|infections. Erythromycin is known as a macrolide antibiotic. It||
0015|018|U|works by stopping the growth of bacteria.||
0015|019|U|   This antibiotic treats or prevents only bacterial infections.||
0015|020|U|It will not work for viral infections (such as common cold, flu).||
0015|021|U|Using any antibiotic when it is not needed can cause it to not||
0015|022|U|work for future infections.||
0015|023|B|||
0015|024|V|OTHER USES:  This section contains uses of this drug that are not||
0015|025|V|listed in the approved professional labeling for the drug but||
0015|026|V|that may be prescribed by your health care professional. Use this||
0015|027|V|drug for a condition that is listed in this section only if it||
0015|028|V|has been so prescribed by your health care professional.||
0015|029|V|   This drug may also be used for a certain type of stomach||
0015|030|V|condition involving slowed digestion (gastroparesis).||
0015|031|B|||
0015|032|H|HOW TO USE:  Take this medication by mouth as directed by your||
0015|033|H|doctor, usually before a meal. This medication is best absorbed||
0015|034|H|when taken on an empty stomach. If nausea occurs, you may take it||
0015|035|H|with food or milk.||
0015|036|H|   This medication has a bitter taste if crushed. Swallow the||
0015|037|H|medication whole. Do not chew or crush.||
0015|038|H|   The dosage and length of treatment are based on your medical||
0015|039|H|condition and response to treatment. Children's dosage is also||
0015|040|H|based on age and weight.||
0015|041|H|   For the best effect, take this antibiotic at evenly spaced||
0015|042|H|times. To help you remember, take this medication at the same||
0015|043|H|time(s) every day.||
0015|044|H|   If you are using this medication to treat an infection,||
0015|045|H|continue to take this medication until the full prescribed amount||
0015|046|H|is finished, even if symptoms disappear after a few days.||
0015|047|H|Stopping the medication too early may result in a return of the||
0015|048|H|infection. Tell your doctor if your condition lasts or gets||
0015|049|H|worse.||
0015|050|H|   If you are taking this medication to prevent certain bacterial||
0015|051|H|infections, take it exactly as directed by your doctor. Do not||
0015|052|H|stop taking the medication without your doctor's approval.||
0015|053|B|||
0015|054|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach pain/cramping,||
0015|055|S|and loss of appetite may occur. Taking this medication with food||
0015|056|S|may lessen these symptoms. If any of these effects last or get||
0015|057|S|worse, tell your doctor or pharmacist promptly.||
0015|058|S|   Remember that this medication has been prescribed because your||
0015|059|S|doctor has judged that the benefit to you is greater than the||
0015|060|S|risk of side effects. Many people using this medication do not||
0015|061|S|have serious side effects.||
0015|062|S|   Tell your doctor right away if you have any serious side||
0015|063|S|effects, including: signs of liver disease (such as||
0015|064|S|nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
0015|065|S|urine, severe stomach/abdominal pain), unusual tiredness, muscle||
0015|066|S|weakness, trouble speaking, blurred vision, drooping eyelids,||
0015|067|S|hearing loss.||
0015|068|S|   Get medical help right away if you have any very serious side||
0015|069|S|effects, including: severe dizziness, fainting, fast/irregular||
0015|070|S|heartbeat.||
0015|071|S|   This medication may rarely cause a severe intestinal condition||
0015|072|S|due to a bacteria called C. difficile. This condition may occur||
0015|073|S|during treatment or weeks to months after treatment has stopped.||
0015|074|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0015|075|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0015|076|S|stool.||
0015|077|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0015|078|S|products because they may make symptoms worse.||
0015|079|S|   Use of this medication for prolonged or repeated periods may||
0015|080|S|result in oral thrush or a new yeast infection. Contact your||
0015|081|S|doctor if you notice white patches in your mouth, a change in||
0015|082|S|vaginal discharge or other new symptoms.||
0015|083|S|   A very serious allergic reaction to this drug is rare.||
0015|084|S|However, get medical help right away if you notice any symptoms||
0015|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0015|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0015|087|S|breathing.||
0015|088|S|   This is not a complete list of possible side effects. If you||
0015|089|S|notice other effects not listed above, contact your doctor or||
0015|090|S|pharmacist.||
0015|091|S|   In the US -||
0015|092|S|   Call your doctor for medical advice about side effects. You||
0015|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0015|094|S|www.fda.gov/medwatch.||
0015|095|S|   In Canada - Call your doctor for medical advice about side||
0015|096|S|effects. You may report side effects to Health Canada at||
0015|097|S|1-866-234-2345.||
0015|098|B|||
0015|099|P|PRECAUTIONS:  Before taking erythromycin, tell your doctor or||
0015|100|P|pharmacist if you are allergic to it; or to other macrolide||
0015|101|P|antibiotics (such as azithromycin, clarithromycin); or if you||
0015|102|P|have any other allergies. This product may contain inactive||
0015|103|P|ingredients, which can cause allergic reactions or other||
0015|104|P|problems. Talk to your pharmacist for more details.||
0015|105|P|   Before using this medication, tell your doctor or pharmacist||
0015|106|P|your medical history, especially of: kidney disease, liver||
0015|107|P|disease, a certain type of muscle disease (myasthenia gravis).||
0015|108|P|   Erythromycin may cause a condition that affects the heart||
0015|109|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0015|110|P|serious (rarely fatal) fast/irregular heartbeat and other||
0015|111|P|symptoms (such as severe dizziness, fainting) that need medical||
0015|112|P|attention right away.||
0015|113|P|   The risk of QT prolongation may be increased if you have||
0015|114|P|certain medical conditions or are taking other drugs that may||
0015|115|P|cause QT prolongation. Before using erythromycin, tell your||
0015|116|P|doctor or pharmacist of all the drugs you take and if you have||
0015|117|P|any of the following conditions: certain heart problems (heart||
0015|118|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0015|119|P|history of certain heart problems (QT prolongation in the EKG,||
0015|120|P|sudden cardiac death).||
0015|121|P|   Low levels of potassium or magnesium in the blood may also||
0015|122|P|increase your risk of QT prolongation. This risk may increase if||
0015|123|P|you use certain drugs (such as diuretics/"water pills") or if you||
0015|124|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0015|125|P|Talk to your doctor about using erythromycin safely.||
0015|126|P|   Erythromycin may cause live bacterial vaccines (such as||
0015|127|P|typhoid vaccine) to not work well. Tell your health care||
0015|128|P|professional that you are using erythromycin before having any||
0015|129|P|immunizations/vaccinations.||
0015|130|P|   Before having surgery, tell your doctor or dentist about all||
0015|131|P|the products you use (including prescription drugs,||
0015|132|P|nonprescription drugs, and herbal products).||
0015|133|P|   Some erythromycin products may contain sodium. Ask your doctor||
0015|134|P|or pharmacist for more information if you are on a||
0015|135|P|salt-restricted diet or if you have a condition that could be||
0015|136|P|worsened by an increase in salt intake (such as heart failure).||
0015|137|P|   Older adults may be more sensitive to the side effects of this||
0015|138|P|drug, especially hearing loss and QT prolongation (see above).||
0015|139|P|   Tell your doctor if you are pregnant before using this||
0015|140|P|medication.||
0015|141|P|   This medication passes into breast milk. Consult your doctor||
0015|142|P|before breastfeeding.||
0015|143|B|||
0015|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0015|145|I|medications work or increase your risk for serious side effects.||
0015|146|I|This document does not contain all possible drug interactions.||
0015|147|I|Keep a list of all the products you use (including||
0015|148|I|prescription/nonprescription drugs and herbal products) and share||
0015|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
0015|150|I|the dosage of any medicines without your doctor's approval.||
0015|151|I|   A product that may interact with this drug is: digoxin.||
0015|152|I|   Many drugs besides erythromycin may affect the heart rhythm||
0015|153|I|(QT prolongation), including amiodarone, dofetilide, pimozide,||
0015|154|I|procainamide, propafenone, quinidine, sotalol, among others.||
0015|155|I|   Other medications can affect the removal of erythromycin from||
0015|156|I|your body, which may affect how erythromycin works. Examples||
0015|157|I|include azole antifungals (such as itraconazole, ketoconazole),||
0015|158|I|certain calcium channel blockers (such as diltiazem, verapamil),||
0015|159|I|certain anti-seizure medications (such as carbamazepine,||
0015|160|I|phenytoin), among others.||
0015|161|I|   Erythromycin can slow down the removal of other drugs from||
0015|162|I|your body, which may affect how they work. Examples of affected||
0015|163|I|drugs include bromocriptine, colchicine, certain benzodiazepines||
0015|164|I|(such as midazolam, triazolam), eletriptan, ergot alkaloids (such||
0015|165|I|as ergotamine, dihydroergotamine), certain drugs to treat||
0015|166|I|erectile dysfunction-ED or pulmonary hypertension (such as||
0015|167|I|sildenafil, tadalafil), certain "statin" drugs (such as||
0015|168|I|lovastatin, simvastatin), vinblastine, among others.||
0015|169|I|   This medication may interfere with certain lab tests (such as||
0015|170|I|urine tests), possibly causing false test results. Make sure lab||
0015|171|I|personnel and all your doctors know you use this drug.||
0015|172|B|||
0015|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0015|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0015|175|O|poison control center right away. US residents can call||
0015|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0015|177|B|||
0015|178|N|NOTES:  Do not share this medication with others.||
0015|179|N|   This medication has been prescribed for your current condition||
0015|180|N|only. Do not use it later for another infection unless your||
0015|181|N|doctor tells you to.||
0015|182|B|||
0015|183|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0015|184|D|remember. If it is near the time of the next dose, skip the||
0015|185|D|missed dose. Take your next dose at the regular time. Do not||
0015|186|D|double the dose to catch up.||
0015|187|B|||
0015|188|R|STORAGE:  Store at room temperature away from light and moisture.||
0015|189|R|Do not store in the bathroom. Keep all medications away from||
0015|190|R|children and pets.||
0015|191|R|   Do not flush medications down the toilet or pour them into a||
0015|192|R|drain unless instructed to do so. Properly discard this product||
0015|193|R|when it is expired or no longer needed. Consult your pharmacist||
0015|194|R|or local waste disposal company.||
0015|195|B|||
0015|196|A|Information last revised July 2025.||
0015|197|A|Copyright(c) 2025 First Databank, Inc.||
0015|198|B|||
0016|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0016|002|Z|does NOT have all possible information about this product. This||
0016|003|Z|information does not assure that this product is safe, effective,||
0016|004|Z|or appropriate for you. This information is not individual||
0016|005|Z|medical advice and does not substitute for the advice of your||
0016|006|Z|health care professional. Always ask your health care||
0016|007|Z|professional for complete information about this product and your||
0016|008|Z|specific health needs.||
0016|009|B|||
0016|010|T|CLINDAMYCIN - ORAL||
0016|011|F|(KLIN-da-MYE-sin)||
0016|012|B|||
0016|013|C|COMMON BRAND NAME(S): Cleocin||
0016|014|B|||
0016|015|W|WARNING:  This medication may rarely cause a severe intestinal||
0016|016|W|condition due to a bacteria called C. difficile. This condition||
0016|017|W|may occur during treatment or weeks to months after treatment has||
0016|018|W|stopped. Tell your doctor right away if you develop diarrhea that||
0016|019|W|doesn't stop, abdominal or stomach pain/cramping, or blood/mucus||
0016|020|W|in your stool. If you have these symptoms, do not use||
0016|021|W|anti-diarrhea or opioid products because they may make symptoms||
0016|022|W|worse.||
0016|023|B|||
0016|024|U|USES:  Clindamycin is used to treat a wide variety of bacterial||
0016|025|U|infections. It is an antibiotic that works by stopping the growth||
0016|026|U|of bacteria.||
0016|027|U|   This antibiotic treats only bacterial infections. It will not||
0016|028|U|work for virus infections (such as common cold, flu). Using any||
0016|029|U|antibiotic when it is not needed can cause it to not work for||
0016|030|U|future infections.||
0016|031|B|||
0016|032|H|HOW TO USE:  Take this medication by mouth with or without food||
0016|033|H|as directed by your doctor, usually 4 times a day (every 6||
0016|034|H|hours). Take it with a full glass of water (8 ounces or 240||
0016|035|H|milliliters) unless your doctor directs you otherwise. Do not lie||
0016|036|H|down for at least 30 minutes after taking this medication.||
0016|037|H|   The dosage is based on your medical condition and response to||
0016|038|H|treatment. Children's dosage is also based on weight.||
0016|039|H|   For the best effect, take this antibiotic at evenly spaced||
0016|040|H|times. To help you remember, take this medication at the same||
0016|041|H|time(s) every day.||
0016|042|H|   Continue to take this medication until the full prescribed||
0016|043|H|amount is finished, even if symptoms disappear after a few days.||
0016|044|H|Stopping the medication too early may result in a return of the||
0016|045|H|infection.||
0016|046|H|   Tell your doctor if your condition lasts or gets worse.||
0016|047|B|||
0016|048|S|SIDE EFFECTS:  See also Warning section.||
0016|049|S|   Nausea, vomiting, or diarrhea may occur. If any of these||
0016|050|S|effects last or get worse, tell your doctor or pharmacist||
0016|051|S|promptly.||
0016|052|S|   Remember that this medication has been prescribed because your||
0016|053|S|doctor has judged that the benefit to you is greater than the||
0016|054|S|risk of side effects. Many people using this medication do not||
0016|055|S|have serious side effects.||
0016|056|S|   Tell your doctor right away if you have any serious side||
0016|057|S|effects, including: painful/difficult swallowing, heartburn,||
0016|058|S|joint pain/swelling, yellowing eyes/skin, dark urine, signs of||
0016|059|S|kidney problems (such as change in the amount of urine).||
0016|060|S|   Use of this medication for prolonged or repeated periods may||
0016|061|S|result in oral thrush or a new vaginal yeast infection. Contact||
0016|062|S|your doctor if you notice white patches in your mouth, a change||
0016|063|S|in vaginal discharge, or other new symptoms.||
0016|064|S|   A very serious allergic reaction to this drug is rare.||
0016|065|S|However, get medical help right away if you notice any symptoms||
0016|066|S|of a serious allergic reaction, including: fever that doesn't go||
0016|067|S|away, new or worsening lymph node swelling, rash,||
0016|068|S|itching/swelling (especially of the face/tongue/throat), severe||
0016|069|S|dizziness, trouble breathing.||
0016|070|S|   This is not a complete list of possible side effects. If you||
0016|071|S|notice other effects not listed above, contact your doctor or||
0016|072|S|pharmacist.||
0016|073|S|   In the US -||
0016|074|S|   Call your doctor for medical advice about side effects. You||
0016|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0016|076|S|www.fda.gov/medwatch.||
0016|077|S|   In Canada - Call your doctor for medical advice about side||
0016|078|S|effects. You may report side effects to Health Canada at||
0016|079|S|1-866-234-2345.||
0016|080|B|||
0016|081|P|PRECAUTIONS:  Before taking clindamycin, tell your doctor or||
0016|082|P|pharmacist if you are allergic to it; or to lincomycin; or if you||
0016|083|P|have any other allergies. This product may contain inactive||
0016|084|P|ingredients, which can cause allergic reactions or other||
0016|085|P|problems. Talk to your pharmacist for more details.||
0016|086|P|   Before using this medication, tell your doctor or pharmacist||
0016|087|P|your medical history, especially of: liver disease, kidney||
0016|088|P|disease, stomach/intestinal diseases (such as colitis, C.||
0016|089|P|difficile-associated diarrhea), allergic conditions (such as||
0016|090|P|asthma, hay fever, eczema).||
0016|091|P|   Clindamycin may cause live bacterial vaccines (such as typhoid||
0016|092|P|vaccine) to not work well. Tell your health care professional||
0016|093|P|that you are using clindamycin before having any||
0016|094|P|immunizations/vaccinations.||
0016|095|P|   Before having surgery, tell your doctor or dentist about all||
0016|096|P|the products you use (including prescription drugs,||
0016|097|P|nonprescription drugs, and herbal products).||
0016|098|P|   Older adults may be more sensitive to the effects of this||
0016|099|P|drug, especially diarrhea.||
0016|100|P|   Tell your doctor if you are pregnant before using this||
0016|101|P|medication.||
0016|102|P|   This medication passes into breast milk. Consult your doctor||
0016|103|P|before breastfeeding.||
0016|104|B|||
0016|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0016|106|I|medications work or increase your risk for serious side effects.||
0016|107|I|This document does not contain all possible drug interactions.||
0016|108|I|Keep a list of all the products you use (including||
0016|109|I|prescription/nonprescription drugs and herbal products) and share||
0016|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0016|111|I|the dosage of any medicines without your doctor's approval.||
0016|112|I|   A product that may interact with this drug is: kaolin-pectin.||
0016|113|B|||
0016|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0016|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0016|116|O|poison control center right away. US residents can call||
0016|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0016|118|B|||
0016|119|N|NOTES:  Do not share this medication with others.||
0016|120|N|   This medication has been prescribed for your current condition||
0016|121|N|only. Do not use it later for another infection unless your||
0016|122|N|doctor tells you to.||
0016|123|N|   If you are using this medication for a longer time, lab and/or||
0016|124|N|medical tests (such as kidney/liver function, blood counts)||
0016|125|N|should be done while you are taking this medication. Consult your||
0016|126|N|doctor for more details.||
0016|127|B|||
0016|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0016|129|D|remember. If it is near the time of the next dose, skip the||
0016|130|D|missed dose. Take your next dose at the regular time. Do not||
0016|131|D|double the dose to catch up.||
0016|132|B|||
0016|133|R|STORAGE:  Store at room temperature away from light and moisture.||
0016|134|R|Do not store in the bathroom. Keep all medications away from||
0016|135|R|children and pets.||
0016|136|R|   Do not flush medications down the toilet or pour them into a||
0016|137|R|drain unless instructed to do so. Properly discard this product||
0016|138|R|when it is expired or no longer needed. Consult your pharmacist||
0016|139|R|or local waste disposal company.||
0016|140|B|||
0016|141|A|Information last revised August 2024.||
0016|142|A|Copyright(c) 2025 First Databank, Inc.||
0016|143|B|||
0017|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0017|002|Z|does NOT have all possible information about this product. This||
0017|003|Z|information does not assure that this product is safe, effective,||
0017|004|Z|or appropriate for you. This information is not individual||
0017|005|Z|medical advice and does not substitute for the advice of your||
0017|006|Z|health care professional. Always ask your health care||
0017|007|Z|professional for complete information about this product and your||
0017|008|Z|specific health needs.||
0017|009|B|||
0017|010|T|CLOMIPHENE - ORAL||
0017|011|F|(KLOE-mi-feen)||
0017|012|B|||
0017|013|C|COMMON BRAND NAME(S): Clomid, Serophene||
0017|014|B|||
0017|015|U|USES:  This medication is used to treat infertility in women. It||
0017|016|U|works by stimulating an increase in the amount of hormones that||
0017|017|U|support the growth and release of a mature egg (ovulation). This||
0017|018|U|medication is not recommended for women whose ovaries no longer||
0017|019|U|make eggs properly (primary pituitary or ovarian failure).||
0017|020|B|||
0017|021|V|OTHER USES:  This section contains uses of this drug that are not||
0017|022|V|listed in the approved professional labeling for the drug but||
0017|023|V|that may be prescribed by your health care professional. Use this||
0017|024|V|drug for a condition that is listed in this section only if it||
0017|025|V|has been so prescribed by your health care professional.||
0017|026|V|   This drug may also be used in men who are not able to produce||
0017|027|V|enough testosterone (hypogonadism).||
0017|028|B|||
0017|029|H|HOW TO USE:  Clomiphene must be taken by mouth exactly as||
0017|030|H|directed by your doctor in order to be most effective. It is||
0017|031|H|important to follow your dosing schedule carefully.||
0017|032|H|   The dosage is based on your medical condition and response to||
0017|033|H|treatment. Do not take it more often or for a longer time than||
0017|034|H|prescribed by your doctor. Long-term treatment with this||
0017|035|H|medication is not recommended and should not be more than 6||
0017|036|H|cycles.||
0017|037|H|   You may be directed to record your body temperature, perform||
0017|038|H|ovulation tests, and properly time sexual intercourse for best||
0017|039|H|results. Ask your doctor if you have any questions.||
0017|040|B|||
0017|041|S|SIDE EFFECTS:  Stomach upset, bloating, abdominal/pelvic||
0017|042|S|fullness, flushing ("hot flashes"), breast tenderness, headache,||
0017|043|S|or dizziness may occur. If any of these effects last or get||
0017|044|S|worse, tell your doctor or pharmacist promptly.||
0017|045|S|   Remember that this medication has been prescribed because your||
0017|046|S|doctor has judged that the benefit to you is greater than the||
0017|047|S|risk of side effects. Many people using this medication do not||
0017|048|S|have serious side effects.||
0017|049|S|   Tell your doctor right away if you have any serious side||
0017|050|S|effects, including: abnormal vaginal bleeding, mental/mood||
0017|051|S|changes.||
0017|052|S|   Vision changes (such as blurred vision, seeing spots or||
0017|053|S|flashes) may sometimes occur during clomiphene treatment,||
0017|054|S|especially if you are exposed to bright light. These side effects||
0017|055|S|usually go away a few days or weeks after treatment is stopped.||
0017|056|S|However, in rare cases, vision changes may be permanent. Get||
0017|057|S|medical help right away if any of the following occur: vision||
0017|058|S|problems/changes, eye pain.||
0017|059|S|   This medication may cause a condition known as ovarian||
0017|060|S|hyperstimulation syndrome (OHSS). Rarely, serious OHSS causes||
0017|061|S|fluid to suddenly build up in the stomach, chest, and heart area.||
0017|062|S|This may occur during therapy or after treatment has been||
0017|063|S|stopped. Get medical help right away if you develop any of the||
0017|064|S|following side effects: severe pain/swelling in the lower abdomen||
0017|065|S|(pelvic) area, sudden/rapid weight gain, nausea/vomiting,||
0017|066|S|diarrhea, shortness of breath, decreased urination,||
0017|067|S|pain/redness/swelling of the legs, chest pain, fast/irregular||
0017|068|S|heartbeat.||
0017|069|S|   A very serious allergic reaction to this drug is rare.||
0017|070|S|However, get medical help right away if you notice any symptoms||
0017|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0017|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0017|073|S|breathing.||
0017|074|S|   This is not a complete list of possible side effects. If you||
0017|075|S|notice other effects not listed above, contact your doctor or||
0017|076|S|pharmacist.||
0017|077|S|   In the US -||
0017|078|S|   Call your doctor for medical advice about side effects. You||
0017|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0017|080|S|www.fda.gov/medwatch.||
0017|081|S|   In Canada - Call your doctor for medical advice about side||
0017|082|S|effects. You may report side effects to Health Canada at||
0017|083|S|1-866-234-2345.||
0017|084|B|||
0017|085|P|PRECAUTIONS:  Before taking clomiphene, tell your doctor or||
0017|086|P|pharmacist if you are allergic to it; or if you have any other||
0017|087|P|allergies. This product may contain inactive ingredients, which||
0017|088|P|can cause allergic reactions or other problems. Talk to your||
0017|089|P|pharmacist for more details.||
0017|090|P|   Before using this medication, tell your doctor or pharmacist||
0017|091|P|your medical history, especially of: ovarian cysts or enlarged||
0017|092|P|ovaries (not due to polycystic ovary syndrome), abnormal vaginal||
0017|093|P|bleeding, liver disease, uterus problems (such as uterine||
0017|094|P|fibroids, endometriosis), thyroid/adrenal gland problems, tumor||
0017|095|P|in the brain (pituitary tumor), high levels of fats/triglycerides||
0017|096|P|in the blood.||
0017|097|P|   Use of clomiphene may result in multiple births (such as||
0017|098|P|twins, triplets). Consult your doctor for more details.||
0017|099|P|   This drug may make you dizzy or cause vision changes. Alcohol||
0017|100|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
0017|101|P|use machinery, or do anything that needs alertness or clear||
0017|102|P|vision until you can do it safely. Limit alcoholic beverages.||
0017|103|P|Talk to your doctor if you are using marijuana (cannabis).||
0017|104|P|   Stop using this medication when you become pregnant. This||
0017|105|P|medication must not be used during pregnancy. If you think you||
0017|106|P|may be pregnant, tell your doctor right away.||
0017|107|P|   It is unknown if this drug passes into breast milk. Consult||
0017|108|P|your doctor before breastfeeding.||
0017|109|B|||
0017|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0017|111|I|medications work or increase your risk for serious side effects.||
0017|112|I|This document does not contain all possible drug interactions.||
0017|113|I|Keep a list of all the products you use (including||
0017|114|I|prescription/nonprescription drugs and herbal products) and share||
0017|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
0017|116|I|the dosage of any medicines without your doctor's approval.||
0017|117|I|   Some products that may interact with this drug include:||
0017|118|I|gonadorelin.||
0017|119|B|||
0017|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0017|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0017|122|O|poison control center right away. US residents can call||
0017|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0017|124|O|Symptoms of overdose may include: vomiting, abdominal/pelvic||
0017|125|O|pain, vision problems.||
0017|126|B|||
0017|127|N|NOTES:  Do not share this medication with others.||
0017|128|N|   Lab and/or medical tests (such as hormone levels, pelvic||
0017|129|N|examination/ultrasound) should be done while you are taking this||
0017|130|N|medication. Keep all medical and lab appointments. Consult your||
0017|131|N|doctor for more details.||
0017|132|B|||
0017|133|D|MISSED DOSE:  If you miss a dose, contact your doctor promptly||
0017|134|D|for further instructions. Do not double the dose to catch up||
0017|135|D|unless your doctor directs you to do so.||
0017|136|B|||
0017|137|R|STORAGE:  Store at room temperature away from light and moisture.||
0017|138|R|Do not store in the bathroom. Keep all medications away from||
0017|139|R|children and pets.||
0017|140|R|   Do not flush medications down the toilet or pour them into a||
0017|141|R|drain unless instructed to do so. Properly discard this product||
0017|142|R|when it is expired or no longer needed. Consult your pharmacist||
0017|143|R|or local waste disposal company.||
0017|144|B|||
0017|145|A|Information last revised October 2024.||
0017|146|A|Copyright(c) 2025 First Databank, Inc.||
0017|147|B|||
0019|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0019|002|Z|does NOT have all possible information about this product. This||
0019|003|Z|information does not assure that this product is safe, effective,||
0019|004|Z|or appropriate for you. This information is not individual||
0019|005|Z|medical advice and does not substitute for the advice of your||
0019|006|Z|health care professional. Always ask your health care||
0019|007|Z|professional for complete information about this product and your||
0019|008|Z|specific health needs.||
0019|009|B|||
0019|010|T|VALPROIC ACID - ORAL||
0019|011|F|(val-PROE-ik As-id)||
0019|012|B|||
0019|013|C|COMMON BRAND NAME(S): Depakene||
0019|014|B|||
0019|015|W|WARNING:  Rarely, this medication has caused serious (sometimes||
0019|016|W|fatal) liver problems, usually within the first 6 months of||
0019|017|W|starting treatment. Lab tests should be performed before you||
0019|018|W|start treatment and periodically during treatment, especially||
0019|019|W|within the first 6 months, to monitor this side effect.||
0019|020|W|   The risk of serious liver problems is increased in children||
0019|021|W|younger than 2 years, especially if they have an inherited||
0019|022|W|metabolic disorder, severe seizure disorder with mental||
0019|023|W|retardation, organic brain disease, or if they take more than one||
0019|024|W|seizure medication. Talk with the doctor about the risks and||
0019|025|W|benefits of using this medication in children younger than 2||
0019|026|W|years.||
0019|027|W|   Due to an increased risk for liver problems, people with||
0019|028|W|certain inherited metabolic disorders (such as||
0019|029|W|Alpers-Huttenlocher syndrome) should not use this medication.||
0019|030|W|Children younger than 2 years who might have these disorders||
0019|031|W|should not use this medication. Children older than 2 years who||
0019|032|W|might have these disorders should be closely monitored during||
0019|033|W|treatment with valproic acid. Talk to your doctor for details.||
0019|034|W|   This medication has rarely caused severe (sometimes fatal)||
0019|035|W|disease of the pancreas (pancreatitis). This may occur at any||
0019|036|W|time during treatment and can quickly worsen.||
0019|037|W|   Tell your doctor right away if you develop symptoms of liver||
0019|038|W|problems or pancreatitis such as nausea/vomiting that doesn't||
0019|039|W|stop, unusual tiredness, weakness, swelling of the face,||
0019|040|W|stomach/abdominal pain, loss of appetite, dark urine, or||
0019|041|W|yellowing eyes/skin.||
0019|042|W|   Taking this medication during pregnancy can cause birth||
0019|043|W|defects, may lower your child's IQ, and may increase the risk of||
0019|044|W|your child having certain brain/mental disorders (such as autism,||
0019|045|W|attention deficit/hyperactivity disorder). Men and women using||
0019|046|W|this medication should discuss the risks and benefits of this||
0019|047|W|medication, other treatment options, and use of reliable forms of||
0019|048|W|birth control with their doctor. If you are planning pregnancy,||
0019|049|W|or if you or your partner becomes pregnant or may be pregnant,||
0019|050|W|immediately talk to your doctor. If you are taking valproic acid||
0019|051|W|only to prevent migraine headaches, this medication must not be||
0019|052|W|used during pregnancy. If you are taking valproic acid to treat||
0019|053|W|seizures or mental/mood problems (such as bipolar disorder), do||
0019|054|W|not stop taking this medication unless directed by your doctor.||
0019|055|W|Untreated seizures and mental/mood problems (such as bipolar||
0019|056|W|disorder) are serious conditions that can harm both a pregnant||
0019|057|W|woman and her unborn baby.||
0019|058|B|||
0019|059|U|USES:  This medication is used to treat seizure disorders,||
0019|060|U|mental/mood conditions (such as manic phase of bipolar disorder),||
0019|061|U|and to prevent migraine headaches. It works by restoring the||
0019|062|U|balance of certain natural substances (neurotransmitters) in the||
0019|063|U|brain.||
0019|064|B|||
0019|065|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0019|066|H|Patient Information Leaflet provided by your pharmacist before||
0019|067|H|you start taking valproic acid and each time you get a refill. If||
0019|068|H|you have any questions, ask your doctor or pharmacist.||
0019|069|H|   Take this medication by mouth as directed by your doctor. You||
0019|070|H|may take it with food if stomach upset occurs. Swallow the||
0019|071|H|capsule whole. Do not crush or chew the capsule, which can||
0019|072|H|irritate the mouth or throat.||
0019|073|H|   The dosage is based on your age, weight, medical condition,||
0019|074|H|response to treatment, and other medications you may be taking.||
0019|075|H|Be sure to tell your doctor and pharmacist about all the products||
0019|076|H|you use (including prescription drugs, nonprescription drugs, and||
0019|077|H|herbal products). Use this medication regularly in order to get||
0019|078|H|the most benefit from it. Remember to use it at the same time||
0019|079|H|each day to keep the amount of medication in your blood constant.||
0019|080|H|   If this medication is used for seizures, do not stop taking it||
0019|081|H|without consulting your doctor. Your condition may become worse||
0019|082|H|if the drug is suddenly stopped. Your dose may need to be||
0019|083|H|gradually decreased.||
0019|084|H|   This medication does not relieve acute migraine headaches.||
0019|085|H|Take other medications as directed by your doctor for acute||
0019|086|H|attacks.||
0019|087|H|   Tell your doctor if your condition does not get better.||
0019|088|B|||
0019|089|S|SIDE EFFECTS:  See also Warning section.||
0019|090|S|   Diarrhea, dizziness, drowsiness, hair loss, blurred/double||
0019|091|S|vision, change in menstrual periods, ringing in the ears,||
0019|092|S|shakiness (tremor), unsteadiness, weight changes may occur. If||
0019|093|S|any of these effects last or get worse, tell your doctor or||
0019|094|S|pharmacist promptly.||
0019|095|S|   Remember that this medication has been prescribed because your||
0019|096|S|doctor has judged that the benefit to you is greater than the||
0019|097|S|risk of side effects. Many people using this medication do not||
0019|098|S|have serious side effects.||
0019|099|S|   Parts of a capsule may appear in your stool. Tell your doctor||
0019|100|S|right away if this occurs.||
0019|101|S|   A small number of people who take anticonvulsants for any||
0019|102|S|condition (such as seizure, bipolar disorder, pain) may||
0019|103|S|experience depression, suicidal thoughts/attempts, or other||
0019|104|S|mental/mood problems. Tell your doctor right away if you or your||
0019|105|S|family/caregiver notice any unusual/sudden changes in your mood,||
0019|106|S|thoughts, or behavior including signs of depression, suicidal||
0019|107|S|thoughts/attempts, thoughts about harming yourself.||
0019|108|S|   Severe (sometimes fatal) brain disorder (encephalopathy) has||
0019|109|S|rarely occurred, particularly in patients with certain metabolic||
0019|110|S|disorders (urea cycle disorders). Tell your doctor right away if||
0019|111|S|you develop unexplained weakness, vomiting, or sudden mental/mood||
0019|112|S|changes (such as confusion).||
0019|113|S|   Get medical help right away if you have any very serious side||
0019|114|S|effects, including: chest pain, easy bruising/unexplained||
0019|115|S|bleeding, fast/slow/irregular heartbeat, swelling of hands/feet,||
0019|116|S|uncontrolled eye movement (nystagmus), feeling cold/shivering,||
0019|117|S|rapid breathing, loss of consciousness.||
0019|118|S|   A very serious allergic reaction to this drug is rare.||
0019|119|S|However, get medical help right away if you notice any symptoms||
0019|120|S|of a serious allergic reaction, including: fever, swollen lymph||
0019|121|S|nodes, rash, itching/swelling (especially of the||
0019|122|S|face/tongue/throat), severe dizziness, trouble breathing.||
0019|123|S|   This is not a complete list of possible side effects. If you||
0019|124|S|notice other effects not listed above, contact your doctor or||
0019|125|S|pharmacist.||
0019|126|S|   In the US -||
0019|127|S|   Call your doctor for medical advice about side effects. You||
0019|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0019|129|S|www.fda.gov/medwatch.||
0019|130|S|   In Canada - Call your doctor for medical advice about side||
0019|131|S|effects. You may report side effects to Health Canada at||
0019|132|S|1-866-234-2345.||
0019|133|B|||
0019|134|P|PRECAUTIONS:  See also Warning section.||
0019|135|P|   Before taking valproic acid, tell your doctor or pharmacist if||
0019|136|P|you are allergic to it; or to divalproex or valproate sodium; or||
0019|137|P|if you have any other allergies. This product may contain||
0019|138|P|inactive ingredients (such as peanut oil), which can cause||
0019|139|P|allergic reactions or other problems. Talk to your pharmacist for||
0019|140|P|more details.||
0019|141|P|   Before using this medication, tell your doctor or pharmacist||
0019|142|P|your medical history, especially of: liver disease, pancreatitis,||
0019|143|P|certain metabolic disorders (such as urea cycle disorders,||
0019|144|P|Alpers-Huttenlocher syndrome), alcohol abuse, bleeding problems,||
0019|145|P|brain disease (dementia), kidney disease, dehydration, poor||
0019|146|P|nutrition.||
0019|147|P|   To lower the chance of getting cut, bruised, or injured, use||
0019|148|P|caution with sharp objects like razors and nail cutters, and||
0019|149|P|avoid activities such as contact sports.||
0019|150|P|   Before having surgery, tell your doctor or dentist about all||
0019|151|P|the products you use (including prescription drugs,||
0019|152|P|nonprescription drugs, and herbal products).||
0019|153|P|   This drug may make you dizzy or drowsy or blur your vision.||
0019|154|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0019|155|P|drowsy. Do not drive, use machinery, or do anything that needs||
0019|156|P|alertness or clear vision until you can do it safely. Avoid||
0019|157|P|alcoholic beverages. Talk to your doctor if you are using||
0019|158|P|marijuana (cannabis).||
0019|159|P|   Children younger than 6 years may be at greater risk for liver||
0019|160|P|problems and pancreatitis.||
0019|161|P|   Older adults may be more sensitive to the side effects of this||
0019|162|P|drug, especially drowsiness, dizziness, unsteadiness, or tremor.||
0019|163|P|Drowsiness, dizziness, unsteadiness can increase the risk of||
0019|164|P|falling.||
0019|165|P|   Tell your doctor if you are pregnant or plan to become||
0019|166|P|pregnant. You should not become pregnant while using valproic||
0019|167|P|acid. Valproic acid may harm an unborn baby. If you become||
0019|168|P|pregnant, talk to your doctor right away about the risks and||
0019|169|P|benefits of this medication. See also Warning section.||
0019|170|P|   This medication passes into breast milk. Consult your doctor||
0019|171|P|before breastfeeding.||
0019|172|B|||
0019|173|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0019|174|I|medications work or increase your risk for serious side effects.||
0019|175|I|This document does not contain all possible drug interactions.||
0019|176|I|Keep a list of all the products you use (including||
0019|177|I|prescription/nonprescription drugs and herbal products) and share||
0019|178|I|it with your doctor and pharmacist. Do not start, stop, or change||
0019|179|I|the dosage of any medicines without your doctor's approval.||
0019|180|I|   Some products that may interact with this drug include:||
0019|181|I|certain antidepressants (such as amitriptyline, nortriptyline,||
0019|182|I|phenelzine), certain antibiotics (carbapenems such as imipenem),||
0019|183|I|mefloquine, orlistat, other medications for seizure (such as||
0019|184|I|ethosuximide, lamotrigine, rufinamide, topiramate), vorinostat,||
0019|185|I|warfarin, zidovudine.||
0019|186|I|   Tell your doctor or pharmacist if you are taking other||
0019|187|I|products that cause drowsiness including alcohol, marijuana||
0019|188|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0019|189|I|drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle||
0019|190|I|relaxants (such as carisoprodol, cyclobenzaprine), and opioid||
0019|191|I|pain relievers (such as codeine, hydrocodone).||
0019|192|I|   Check the labels on all your medicines (such as allergy or||
0019|193|I|cough-and-cold products) because they may contain ingredients||
0019|194|I|that cause drowsiness. Ask your pharmacist about using those||
0019|195|I|products safely.||
0019|196|I|   This drug may interfere with certain lab tests (such as urine||
0019|197|I|ketones). Make sure lab personnel and your doctors know you use||
0019|198|I|this medication.||
0019|199|B|||
0019|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0019|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0019|202|O|poison control center right away. US residents can call||
0019|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0019|204|O|Symptoms of overdose may include: excessive drowsiness, coma,||
0019|205|O|irregular/slow heartbeat.||
0019|206|B|||
0019|207|N|NOTES:  Do not share this medication with others.||
0019|208|N|   Lab and/or medical tests (such as drug levels, liver function,||
0019|209|N|complete blood counts, clotting tests) should be done before you||
0019|210|N|start taking this medication and while you are taking it. Keep||
0019|211|N|all medical and lab appointments. Consult your doctor for more||
0019|212|N|details.||
0019|213|B|||
0019|214|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0019|215|D|If it is near the time of the next dose, skip the missed dose.||
0019|216|D|Use your next dose at the regular time. Do not double the dose to||
0019|217|D|catch up.||
0019|218|B|||
0019|219|R|STORAGE:  Store at room temperature away from light and moisture.||
0019|220|R|Do not store in the bathroom. Keep all medications away from||
0019|221|R|children and pets.||
0019|222|R|   Do not flush medications down the toilet or pour them into a||
0019|223|R|drain unless instructed to do so. Properly discard this product||
0019|224|R|when it is expired or no longer needed. Consult your pharmacist||
0019|225|R|or local waste disposal company.||
0019|226|B|||
0019|227|M|MEDICAL ALERT:  Your condition can cause complications in a||
0019|228|M|medical emergency. For information about enrolling in MedicAlert,||
0019|229|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0019|230|B|||
0019|231|A|Information last revised January 2025.||
0019|232|A|Copyright(c) 2025 First Databank, Inc.||
0019|233|B|||
0020|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0020|002|Z|does NOT have all possible information about this product. This||
0020|003|Z|information does not assure that this product is safe, effective,||
0020|004|Z|or appropriate for you. This information is not individual||
0020|005|Z|medical advice and does not substitute for the advice of your||
0020|006|Z|health care professional. Always ask your health care||
0020|007|Z|professional for complete information about this product and your||
0020|008|Z|specific health needs.||
0020|009|B|||
0020|010|T|COLCHICINE - ORAL||
0020|011|F|(KOL-chi-seen)||
0020|012|B|||
0020|013|C|COMMON BRAND NAME(S): Colcrys||
0020|014|B|||
0020|015|U|USES:  This medication is used to prevent or treat gout attacks||
0020|016|U|(flares). Usually gout symptoms develop suddenly and involve only||
0020|017|U|one or a few joints. The big toe, knee, or ankle joints are most||
0020|018|U|often affected. Gout is caused by too much uric acid in the||
0020|019|U|blood. When uric acid levels in the blood are too high, the uric||
0020|020|U|acid may form hard crystals in your joints. Colchicine works by||
0020|021|U|decreasing swelling and lessening the build up of uric acid||
0020|022|U|crystals that cause pain in the affected joint(s).||
0020|023|U|   This medication is also used to prevent attacks of pain in the||
0020|024|U|abdomen, chest, or joints caused by a certain inherited disease||
0020|025|U|(familial Mediterranean fever). It is thought to work by||
0020|026|U|decreasing your body's production of a certain protein (amyloid||
0020|027|U|A) that builds up in people with familial Mediterranean fever.||
0020|028|U|   Colchicine is not a pain medication and should not be used to||
0020|029|U|relieve other causes of pain.||
0020|030|B|||
0020|031|V|OTHER USES:  This section contains uses of this drug that are not||
0020|032|V|listed in the approved professional labeling for the drug but||
0020|033|V|that may be prescribed by your health care professional. Use this||
0020|034|V|drug for a condition that is listed in this section only if it||
0020|035|V|has been so prescribed by your health care professional.||
0020|036|V|   This medication may also be used to reduce swelling and||
0020|037|V|inflammation of the sac that covers the outside of the heart, a||
0020|038|V|condition called pericarditis.||
0020|039|V|   Colchicine is also available in other brands and strengths to||
0020|040|V|reduce the risk of serious heart disease and lower the risk of||
0020|041|V|death from heart disease. Do not take this medication with any||
0020|042|V|other product that contains colchicine.||
0020|043|B|||
0020|044|H|HOW TO USE:  Read the Medication Guide provided by your||
0020|045|H|pharmacist before you start taking colchicine and each time you||
0020|046|H|get a refill. If you have any questions, ask your doctor or||
0020|047|H|pharmacist.||
0020|048|H|   Take this medication by mouth with or without food, exactly as||
0020|049|H|directed by your doctor. Dosing recommendations vary widely and||
0020|050|H|may be different from the following recommendations. Taking more||
0020|051|H|than the recommended dose may not increase this drug's||
0020|052|H|effectiveness and may increase your risk for side effects. Ask||
0020|053|H|your doctor or pharmacist for more details.||
0020|054|H|   If you are taking this medication to treat a gout attack,||
0020|055|H|carefully follow the directions given by your doctor. This||
0020|056|H|medication works best if you take it at the first sign of an||
0020|057|H|attack. The recommended dose is 1.2 milligrams at the first sign||
0020|058|H|of an attack, followed by 0.6 milligrams one hour later. The||
0020|059|H|maximum recommended dose is 1.8 milligrams taken over a 1-hour||
0020|060|H|period. Ask your doctor ahead of time about how soon you can||
0020|061|H|repeat treatment with this medication if you have another gout||
0020|062|H|attack.||
0020|063|H|   If you are taking this medication to prevent gout attacks or||
0020|064|H|for pericarditis, ask your doctor about the dose and schedule you||
0020|065|H|should follow. Carefully follow your doctor's directions.||
0020|066|H|   If you are taking this medication to prevent attacks of pain||
0020|067|H|caused by familial Mediterranean fever, the usual dose is 1.2 to||
0020|068|H|2.4 milligrams daily. The total dose may be taken once daily or||
0020|069|H|divided into two doses a day. Your doctor may need to adjust your||
0020|070|H|dose to control your symptoms or if you have side effects.||
0020|071|H|   The dosage is based on your medical condition, other||
0020|072|H|medications you may be taking, and response to treatment. Be sure||
0020|073|H|to tell your doctor and pharmacist about all the products you use||
0020|074|H|(including prescription drugs, nonprescription drugs, and herbal||
0020|075|H|products).||
0020|076|H|   Do not increase your dose or use this drug more often or for||
0020|077|H|longer than prescribed. Your condition will not improve any||
0020|078|H|faster, and your risk of side effects will increase. Serious side||
0020|079|H|effects may occur even at usual prescribed doses.||
0020|080|H|   If your doctor directs you to take colchicine regularly, use||
0020|081|H|it regularly to get the most benefit from it. To help you||
0020|082|H|remember, take it at the same time(s) each day.||
0020|083|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0020|084|H|using this medication unless your doctor or pharmacist says you||
0020|085|H|may do so safely. Grapefruit can increase the chance of side||
0020|086|H|effects with this medicine. Ask your doctor or pharmacist for||
0020|087|H|more details.||
0020|088|H|   If you are taking this medication to treat symptoms due to||
0020|089|H|familial Mediterranean fever, tell your doctor if your condition||
0020|090|H|does not get better or if it gets worse.||
0020|091|B|||
0020|092|S|SIDE EFFECTS:  Diarrhea, nausea, cramping, abdominal pain, and||
0020|093|S|vomiting may occur. If any of these effects last or get worse,||
0020|094|S|tell your doctor or pharmacist promptly.||
0020|095|S|   Remember that this medication has been prescribed because your||
0020|096|S|doctor has judged that the benefit to you is greater than the||
0020|097|S|risk of side effects. Many people using this medication do not||
0020|098|S|have serious side effects.||
0020|099|S|   Stop taking this medication and get medical help right away if||
0020|100|S|you have any very serious side effects, including: unusual||
0020|101|S|bleeding/bruising, severe diarrhea or vomiting, muscle weakness||
0020|102|S|or pain, numbness/tingling in your fingers or toes, pale or gray||
0020|103|S|color of the lips/tongue/palms of hands, signs of infection (such||
0020|104|S|as sore throat that doesn't go away, fever, chills), unusual||
0020|105|S|weakness/tiredness, fast heartbeat, shortness of breath, signs of||
0020|106|S|kidney problems (such as change in the amount of urine).||
0020|107|S|   A very serious allergic reaction to this drug is rare.||
0020|108|S|However, get medical help right away if you notice any symptoms||
0020|109|S|of a serious allergic reaction, including: rash, itching/swelling||
0020|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0020|111|S|breathing.||
0020|112|S|   This is not a complete list of possible side effects. If you||
0020|113|S|notice other effects not listed above, contact your doctor or||
0020|114|S|pharmacist.||
0020|115|S|   In the US -||
0020|116|S|   Call your doctor for medical advice about side effects. You||
0020|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0020|118|S|www.fda.gov/medwatch.||
0020|119|S|   In Canada - Call your doctor for medical advice about side||
0020|120|S|effects. You may report side effects to Health Canada at||
0020|121|S|1-866-234-2345.||
0020|122|B|||
0020|123|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0020|124|P|pharmacist if you are allergic to it; or if you have any other||
0020|125|P|allergies. This product may contain inactive ingredients, which||
0020|126|P|can cause allergic reactions or other problems. Talk to your||
0020|127|P|pharmacist for more details.||
0020|128|P|   Before using this medication, tell your doctor or pharmacist||
0020|129|P|your medical history, especially of: kidney problems, liver||
0020|130|P|problems (such as cirrhosis).||
0020|131|P|   Alcohol can decrease this drug's effectiveness. Limit alcohol||
0020|132|P|while taking this drug.||
0020|133|P|   This medication can affect how well your body absorbs some||
0020|134|P|foods and nutrients (such as vitamin B12). Consult your doctor or||
0020|135|P|pharmacist for more details.||
0020|136|P|   Before having surgery, tell your doctor or dentist about all||
0020|137|P|the products you use (including prescription drugs,||
0020|138|P|nonprescription drugs, and herbal products).||
0020|139|P|   Older adults may be more sensitive to the side effects of this||
0020|140|P|drug, especially muscle weakness/pain and numbness/tingling in||
0020|141|P|their fingers or toes.||
0020|142|P|   Colchicine can decrease sperm production, which may affect the||
0020|143|P|ability of a male to father a child. Consult your doctor for more||
0020|144|P|information.||
0020|145|P|   During pregnancy, this medication should be used only when||
0020|146|P|clearly needed. Discuss the risks and benefits with your doctor.||
0020|147|P|   This medication passes into breast milk. Consult your doctor||
0020|148|P|before breastfeeding.||
0020|149|B|||
0020|150|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
0020|151|I|   Drug interactions may change how your medications work or||
0020|152|I|increase your risk for serious side effects. This document does||
0020|153|I|not contain all possible drug interactions. Keep a list of all||
0020|154|I|the products you use (including prescription/nonprescription||
0020|155|I|drugs and herbal products) and share it with your doctor and||
0020|156|I|pharmacist. Do not start, stop, or change the dosage of any||
0020|157|I|medicines without your doctor's approval.||
0020|158|I|   Other medications can affect the removal of colchicine from||
0020|159|I|your body, which may affect how colchicine works or increase the||
0020|160|I|risk of serious side effects. Examples include atazanavir,||
0020|161|I|certain azole antifungals (such as itraconazole, ketoconazole),||
0020|162|I|diltiazem, macrolide antibiotics (such as clarithromycin,||
0020|163|I|erythromycin), ritonavir, telithromycin, verapamil, among others.||
0020|164|I|   Colchicine may rarely cause a certain serious (even fatal)||
0020|165|I|muscle damage (rhabdomyolysis). This muscle damage releases||
0020|166|I|substances that can lead to serious kidney problems. The risk may||
0020|167|I|be increased if other drugs that may also cause rhabdomyolysis||
0020|168|I|are taken along with colchicine. Some affected drugs include:||
0020|169|I|digoxin, gemfibrozil, pravastatin, simvastatin, among others.||
0020|170|I|   This medication may interfere with certain lab tests, possibly||
0020|171|I|causing false test results. Make sure lab personnel and all your||
0020|172|I|doctors know you use this drug.||
0020|173|I|   Do not take this medication with any other product that||
0020|174|I|contains colchicine.||
0020|175|B|||
0020|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0020|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0020|178|O|poison control center right away. US residents can call||
0020|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0020|180|O|Symptoms of overdose may include: severe||
0020|181|O|nausea/vomiting/diarrhea, abdominal pain, trouble breathing,||
0020|182|O|weakness.||
0020|183|B|||
0020|184|N|NOTES:  Do not share this medication with others.||
0020|185|N|   Being overweight, drinking too much alcohol, and eating||
0020|186|N|certain foods may worsen gout symptoms. Limit alcohol and ask||
0020|187|N|your doctor, pharmacist, or dietitian about avoiding foods high||
0020|188|N|in purines that may worsen gout (such as anchovies, bacon, beer,||
0020|189|N|sardines, organ meats including liver/kidneys).||
0020|190|N|   Lab and/or medical tests (such as blood tests, liver/kidney||
0020|191|N|function) may be done while you are taking this medication. Keep||
0020|192|N|all medical and lab appointments. Consult your doctor for more||
0020|193|N|details.||
0020|194|B|||
0020|195|D|MISSED DOSE:  If you are taking colchicine regularly and miss a||
0020|196|D|dose, take it as soon as you remember. If it is near the time of||
0020|197|D|the next dose, skip the missed dose. Take your next dose at the||
0020|198|D|regular time. Do not double the dose to catch up.||
0020|199|B|||
0020|200|R|STORAGE:  Store at room temperature away from light and moisture.||
0020|201|R|Do not store in the bathroom. Keep all medications away from||
0020|202|R|children and pets.||
0020|203|R|   Do not flush medications down the toilet or pour them into a||
0020|204|R|drain unless instructed to do so. Properly discard this product||
0020|205|R|when it is expired or no longer needed. Consult your pharmacist||
0020|206|R|or local waste disposal company.||
0020|207|B|||
0020|208|A|Information last revised April 2025.||
0020|209|A|Copyright(c) 2025 First Databank, Inc.||
0020|210|B|||
0024|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0024|002|Z|does NOT have all possible information about this product. This||
0024|003|Z|information does not assure that this product is safe, effective,||
0024|004|Z|or appropriate for you. This information is not individual||
0024|005|Z|medical advice and does not substitute for the advice of your||
0024|006|Z|health care professional. Always ask your health care||
0024|007|Z|professional for complete information about this product and your||
0024|008|Z|specific health needs.||
0024|009|B|||
0024|010|T|CLONIDINE - ORAL||
0024|011|F|(KLON-i-deen)||
0024|012|B|||
0024|013|C|COMMON BRAND NAME(S): Catapres, Javadin||
0024|014|B|||
0024|015|U|USES:  This medication is used alone or with other medications to||
0024|016|U|treat high blood pressure (hypertension). Lowering high blood||
0024|017|U|pressure helps prevent strokes, heart attacks, and kidney||
0024|018|U|problems. Clonidine belongs to a class of drugs (central alpha||
0024|019|U|agonists) that act in the brain to lower blood pressure. It works||
0024|020|U|by relaxing blood vessels so blood can flow more easily.||
0024|021|B|||
0024|022|V|OTHER USES:  This section contains uses of this drug that are not||
0024|023|V|listed in the approved professional labeling for the drug but||
0024|024|V|that may be prescribed by your health care professional. Use this||
0024|025|V|drug for a condition that is listed in this section only if it||
0024|026|V|has been so prescribed by your health care professional.||
0024|027|V|   This drug may also be used for attention deficit hyperactivity||
0024|028|V|disorder (ADHD), for hot flashes that occur with menopause, for||
0024|029|V|withdrawal symptoms from opioid drugs, and to help people quit||
0024|030|V|smoking.||
0024|031|B|||
0024|032|H|HOW TO USE:  Take this medication by mouth with or without food||
0024|033|H|as directed by your doctor, usually twice daily (in the morning||
0024|034|H|and at bedtime). If the doses are not equal, take the larger dose||
0024|035|H|at bedtime to decrease the risk of side effects.||
0024|036|H|   If you are using the liquid form of this medication, carefully||
0024|037|H|measure the dose using a special measuring device/spoon. Do not||
0024|038|H|use a household spoon because you may not get the correct dose.||
0024|039|H|   The dosage is based on your medical condition and response to||
0024|040|H|treatment.||
0024|041|H|   Use this medication regularly to get the most benefit from it.||
0024|042|H|To help you remember, take it at the same times each day. Keep||
0024|043|H|taking this medication even if you feel well. Most people with||
0024|044|H|high blood pressure do not feel sick.||
0024|045|H|   Do not stop taking this medication without consulting your||
0024|046|H|doctor. You may experience symptoms such as nervousness,||
0024|047|H|agitation, shaking, and headache. A rapid rise in blood pressure||
0024|048|H|may also occur if the drug is suddenly stopped. The risk is||
0024|049|H|greater if you have used this drug for a long time or in high||
0024|050|H|doses, or if you are also taking a beta blocker (such as||
0024|051|H|atenolol). There have also been rare reports of severe, possibly||
0024|052|H|fatal reactions (such as stroke) from stopping this drug too||
0024|053|H|quickly. It is important that you do not run out of clonidine or||
0024|054|H|miss any doses. Tell your doctor or pharmacist right away if you||
0024|055|H|are unable to take the medication (for example, due to vomiting).||
0024|056|H|To prevent any reactions while you are stopping treatment with||
0024|057|H|this drug, your doctor may reduce your dose gradually. Consult||
0024|058|H|your doctor or pharmacist for more details. Report any new or||
0024|059|H|worsening symptoms right away.||
0024|060|H|   When used for a long time, this medication may not work as||
0024|061|H|well and may require different dosing or an additional||
0024|062|H|medication. Talk with your doctor if this medication stops||
0024|063|H|working well (such as your blood pressure readings remain high or||
0024|064|H|increase).||
0024|065|B|||
0024|066|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, dry mouth,||
0024|067|S|or constipation may occur. If any of these effects last or get||
0024|068|S|worse, tell your doctor or pharmacist promptly.||
0024|069|S|   To reduce the risk of dizziness and lightheadedness, get up||
0024|070|S|slowly when rising from a sitting or lying position.||
0024|071|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0024|072|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0024|073|S|substitute.||
0024|074|S|   Remember that this medication has been prescribed because your||
0024|075|S|doctor has judged that the benefit to you is greater than the||
0024|076|S|risk of side effects. Many people using this medication do not||
0024|077|S|have serious side effects.||
0024|078|S|   Tell your doctor right away if you have any serious side||
0024|079|S|effects, including: fainting, slow/irregular heartbeat,||
0024|080|S|mental/mood changes (such as irritability, depression).||
0024|081|S|   A very serious allergic reaction to this drug is rare.||
0024|082|S|However, get medical help right away if you notice any symptoms||
0024|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0024|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0024|085|S|breathing.||
0024|086|S|   This is not a complete list of possible side effects. If you||
0024|087|S|notice other effects not listed above, contact your doctor or||
0024|088|S|pharmacist.||
0024|089|S|   In the US -||
0024|090|S|   Call your doctor for medical advice about side effects. You||
0024|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0024|092|S|www.fda.gov/medwatch.||
0024|093|S|   In Canada - Call your doctor for medical advice about side||
0024|094|S|effects. You may report side effects to Health Canada at||
0024|095|S|1-866-234-2345.||
0024|096|B|||
0024|097|P|PRECAUTIONS:  Before taking clonidine, tell your doctor or||
0024|098|P|pharmacist if you are allergic to it (including having a rash||
0024|099|P|while using clonidine patches); or if you have any other||
0024|100|P|allergies. This product may contain inactive ingredients, which||
0024|101|P|can cause allergic reactions or other problems. Talk to your||
0024|102|P|pharmacist for more details.||
0024|103|P|   Before using this medication, tell your doctor or pharmacist||
0024|104|P|your medical history, especially of: kidney disease, heart rhythm||
0024|105|P|problems (such as slow/irregular heartbeat, second- or||
0024|106|P|third-degree atrioventricular block).||
0024|107|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0024|108|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0024|109|P|machinery, or do anything that needs alertness until you can do||
0024|110|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0024|111|P|are using marijuana (cannabis).||
0024|112|P|   Before having surgery, tell your doctor or dentist about all||
0024|113|P|the products you use (including prescription drugs,||
0024|114|P|nonprescription drugs, and herbal products).||
0024|115|P|   Contact lens wearers may need to use wetting eye drops since||
0024|116|P|this medication can cause dry eyes.||
0024|117|P|   Older adults may be more sensitive to the side effects of this||
0024|118|P|product, especially dizziness, or drowsiness. These side effects||
0024|119|P|may increase the risk of falling.||
0024|120|P|   During pregnancy, this medication should be used only when||
0024|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
0024|122|P|   This drug passes into breast milk and may have undesirable||
0024|123|P|effects on a nursing infant. Consult your doctor before||
0024|124|P|breastfeeding.||
0024|125|B|||
0024|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0024|127|I|medications work or increase your risk for serious side effects.||
0024|128|I|This document does not contain all possible drug interactions.||
0024|129|I|Keep a list of all the products you use (including||
0024|130|I|prescription/nonprescription drugs and herbal products) and share||
0024|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
0024|132|I|the dosage of any medicines without your doctor's approval.||
0024|133|I|   Tell your doctor or pharmacist if you are taking other||
0024|134|I|products that cause drowsiness including alcohol, marijuana||
0024|135|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0024|136|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0024|137|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0024|138|I|codeine).||
0024|139|I|   Check the labels on all your medicines (such as allergy or||
0024|140|I|cough-and-cold products) because they may contain ingredients||
0024|141|I|that cause drowsiness. Ask your pharmacist about using those||
0024|142|I|products safely.||
0024|143|I|   Some products have ingredients that could raise your blood||
0024|144|I|pressure. Tell your pharmacist what products you are using, and||
0024|145|I|ask how to use them safely (especially cough-and-cold products,||
0024|146|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0024|147|B|||
0024|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0024|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0024|150|O|poison control center right away. US residents can call||
0024|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0024|152|O|Symptoms of overdose may include: severe dizziness/drowsiness,||
0024|153|O|fainting, slow/irregular heartbeat, slow/shallow breathing,||
0024|154|O|seizures.||
0024|155|B|||
0024|156|N|NOTES:  Do not share this medication with others.||
0024|157|N|   Lifestyle changes such as stress reduction programs, exercise,||
0024|158|N|and dietary changes may increase the effectiveness of this||
0024|159|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0024|160|N|changes that might benefit you.||
0024|161|N|   Check your blood pressure and pulse (heart rate) regularly||
0024|162|N|while taking this medication. Learn how to monitor your own blood||
0024|163|N|pressure and pulse at home, and share the results with your||
0024|164|N|doctor.||
0024|165|B|||
0024|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0024|167|D|remember. If it is near the time of the next dose, skip the||
0024|168|D|missed dose. Take your next dose at the regular time. Do not||
0024|169|D|double the dose to catch up. If you miss 2 or more doses in a||
0024|170|D|row, contact your doctor right away.||
0024|171|B|||
0024|172|R|STORAGE:  Store at room temperature away from light and moisture.||
0024|173|R|Do not store in the bathroom. Once the bottle is opened, the||
0024|174|R|liquid form expires after 60 days. Keep all medications away from||
0024|175|R|children and pets.||
0024|176|R|   Do not flush medications down the toilet or pour them into a||
0024|177|R|drain unless instructed to do so. Properly discard this product||
0024|178|R|when it is expired or no longer needed. Consult your pharmacist||
0024|179|R|or local waste disposal company.||
0024|180|B|||
0024|181|A|Information last revised November 2025.||
0024|182|A|Copyright(c) 2025 First Databank, Inc.||
0024|183|B|||
0025|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0025|002|Z|does NOT have all possible information about this product. This||
0025|003|Z|information does not assure that this product is safe, effective,||
0025|004|Z|or appropriate for you. This information is not individual||
0025|005|Z|medical advice and does not substitute for the advice of your||
0025|006|Z|health care professional. Always ask your health care||
0025|007|Z|professional for complete information about this product and your||
0025|008|Z|specific health needs.||
0025|009|B|||
0025|010|T|DIPHENOXYLATE/ATROPINE - ORAL||
0025|011|F|(DYE-fen-OX-i-late/AT-roe-peen)||
0025|012|B|||
0025|013|C|COMMON BRAND NAME(S): Lomotil||
0025|014|B|||
0025|015|U|USES:  This medication is used to treat diarrhea. It helps to||
0025|016|U|decrease the number and frequency of bowel movements. It works by||
0025|017|U|slowing the movement of the intestines. Diphenoxylate is similar||
0025|018|U|to opioid pain relievers, but it acts mainly to slow the gut.||
0025|019|U|Atropine belongs to a class of drugs known as anticholinergics,||
0025|020|U|which help to dry up body fluids and also slow gut movement.||
0025|021|U|   This medication should not be used to treat diarrhea caused by||
0025|022|U|certain types of infection (such as C. difficile-associated||
0025|023|U|diarrhea following antibiotic therapy). Talk to your doctor for||
0025|024|U|more details.||
0025|025|U|   This medication is not recommended for use in children younger||
0025|026|U|than 6 years due to an increased risk of serious side effects||
0025|027|U|(such as breathing problems).||
0025|028|B|||
0025|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
0025|030|H|doctor, usually 4 times a day. The dosage is based on your||
0025|031|H|medical condition and response to treatment. Children's dosage is||
0025|032|H|also based on weight. If you need to continue treatment once your||
0025|033|H|diarrhea is controlled, your doctor may direct you to lower your||
0025|034|H|dosage. Do not increase your dose, take it more often, or use it||
0025|035|H|for longer than prescribed.||
0025|036|H|   If you are using the liquid form of this medication, carefully||
0025|037|H|measure the dose using a special measuring device/spoon. Do not||
0025|038|H|use a household spoon because you may not get the correct dose.||
0025|039|H|   It is important that you drink the proper amount of fluids and||
0025|040|H|electrolytes to prevent dehydration. Tell your doctor right away||
0025|041|H|if you develop signs of dehydration (such as extreme thirst,||
0025|042|H|decreased urination, muscle cramps, weakness, fainting). You may||
0025|043|H|also need to change to a bland diet during this time to reduce||
0025|044|H|irritation to your stomach/intestines. Consult your doctor or||
0025|045|H|pharmacist for more information.||
0025|046|H|   If you suddenly stop using this medication, you may have||
0025|047|H|withdrawal symptoms (such as stomach cramps, nausea, vomiting).||
0025|048|H|To help prevent withdrawal, your doctor may lower your dose||
0025|049|H|slowly. Withdrawal is more likely if you have used this||
0025|050|H|medication for a long time or in high doses. Tell your doctor or||
0025|051|H|pharmacist right away if you have withdrawal.||
0025|052|H|   Tell your doctor if your condition does not get better after 2||
0025|053|H|days.||
0025|054|B|||
0025|055|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, tiredness,||
0025|056|S|blurred vision, dry mouth, and loss of appetite may occur. If any||
0025|057|S|of these effects last or get worse, tell your doctor or||
0025|058|S|pharmacist promptly.||
0025|059|S|   Remember that this medication has been prescribed because your||
0025|060|S|doctor has judged that the benefit to you is greater than the||
0025|061|S|risk of side effects. Many people using this medication do not||
0025|062|S|have serious side effects.||
0025|063|S|   Tell your doctor right away if you have any serious side||
0025|064|S|effects, including: stomach/abdominal pain or swelling, severe||
0025|065|S|nausea, vomiting, mental/mood changes (such as confusion,||
0025|066|S|depression, restlessness), numbness/tingling of arms/legs.||
0025|067|S|   Get medical help right away if you have any very serious side||
0025|068|S|effects, including: eye pain/swelling/redness, vision changes||
0025|069|S|(such as seeing rainbows around lights at night).||
0025|070|S|   A very serious allergic reaction to this drug is rare.||
0025|071|S|However, get medical help right away if you notice any symptoms||
0025|072|S|of a serious allergic reaction, including: rash, itching/swelling||
0025|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0025|074|S|breathing.||
0025|075|S|   This is not a complete list of possible side effects. If you||
0025|076|S|notice other effects not listed above, contact your doctor or||
0025|077|S|pharmacist.||
0025|078|S|   In the US -||
0025|079|S|   Call your doctor for medical advice about side effects. You||
0025|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0025|081|S|www.fda.gov/medwatch.||
0025|082|S|   In Canada - Call your doctor for medical advice about side||
0025|083|S|effects. You may report side effects to Health Canada at||
0025|084|S|1-866-234-2345.||
0025|085|B|||
0025|086|P|PRECAUTIONS:  Before taking diphenoxylate with atropine, tell||
0025|087|P|your doctor or pharmacist if you are allergic to either drug; or||
0025|088|P|to hyoscyamine; or if you have any other allergies. This product||
0025|089|P|may contain inactive ingredients, which can cause allergic||
0025|090|P|reactions or other problems. Talk to your pharmacist for more||
0025|091|P|details.||
0025|092|P|   Before using this medication, tell your doctor or pharmacist||
0025|093|P|your medical history, especially of: liver disease (such as||
0025|094|P|obstructive jaundice, cirrhosis), dehydration, mineral imbalance,||
0025|095|P|a certain type of bowel disease (acute ulcerative colitis),||
0025|096|P|personal or family history of glaucoma (angle-closure type).||
0025|097|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0025|098|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0025|099|P|machinery, or do anything that needs alertness until you can do||
0025|100|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0025|101|P|are using marijuana (cannabis).||
0025|102|P|   Liquid forms of this product may contain alcohol. Caution is||
0025|103|P|advised if you have alcohol dependence or liver disease. Ask your||
0025|104|P|doctor or pharmacist about using this product safely.||
0025|105|P|   Before having surgery, tell your doctor or dentist about all||
0025|106|P|the products you use (including prescription drugs,||
0025|107|P|nonprescription drugs, and herbal products).||
0025|108|P|   Children, particularly those with Down's syndrome, may be more||
0025|109|P|sensitive to the side effects of this drug. Very serious||
0025|110|P|(possibly fatal) effects may occur if too much of this medication||
0025|111|P|is taken by children.||
0025|112|P|   During pregnancy, this medication should be used only when||
0025|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
0025|114|P|   This medication passes into breast milk. Consult your doctor||
0025|115|P|before breastfeeding.||
0025|116|B|||
0025|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0025|118|I|medications work or increase your risk for serious side effects.||
0025|119|I|This document does not contain all possible drug interactions.||
0025|120|I|Keep a list of all the products you use (including||
0025|121|I|prescription/nonprescription drugs and herbal products) and share||
0025|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
0025|123|I|the dosage of any medicines without your doctor's approval.||
0025|124|I|   Some products that may interact with this drug are:||
0025|125|I|pramlintide, MAO inhibitors (isocarboxazid, linezolid,||
0025|126|I|metaxalone, methylene blue, moclobemide, phenelzine,||
0025|127|I|procarbazine, rasagiline, safinamide, selegiline,||
0025|128|I|tranylcypromine), naltrexone, potassium tablets/capsules.||
0025|129|I|   Tell your doctor or pharmacist if you are taking other||
0025|130|I|products that cause drowsiness such as opioid pain or cough||
0025|131|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0025|132|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0025|133|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0025|134|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0025|135|I|diphenhydramine).||
0025|136|I|   Check the labels on all your medicines (such as allergy or||
0025|137|I|cough-and-cold products) because they may contain ingredients||
0025|138|I|that cause drowsiness. Ask your pharmacist about using those||
0025|139|I|products safely.||
0025|140|B|||
0025|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0025|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0025|143|O|poison control center right away. US residents can call||
0025|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0025|145|O|Symptoms of overdose may include: severe drowsiness, muscle||
0025|146|O|weakness, fast heartbeat, high fever, unusually||
0025|147|O|fast/slow/irregular breathing, seizures, loss of consciousness.||
0025|148|B|||
0025|149|N|NOTES:  Do not share this medication with others. Sharing it is||
0025|150|N|against the law.||
0025|151|B|||
0025|152|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0025|153|D|remember. If it is near the time of the next dose, skip the||
0025|154|D|missed dose. Take your next dose at the regular time. Do not||
0025|155|D|double the dose to catch up.||
0025|156|B|||
0025|157|R|STORAGE:  Store at room temperature away from light and moisture.||
0025|158|R|Do not store in the bathroom. Do not freeze the liquid. Keep all||
0025|159|R|medications away from children and pets.||
0025|160|R|   Do not flush medications down the toilet or pour them into a||
0025|161|R|drain unless instructed to do so. Properly discard this product||
0025|162|R|when it is expired or no longer needed. Consult your pharmacist||
0025|163|R|or local waste disposal company.||
0025|164|B|||
0025|165|A|Information last revised October 2024.||
0025|166|A|Copyright(c) 2025 First Databank, Inc.||
0025|167|B|||
0026|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0026|002|Z|does NOT have all possible information about this product. This||
0026|003|Z|information does not assure that this product is safe, effective,||
0026|004|Z|or appropriate for you. This information is not individual||
0026|005|Z|medical advice and does not substitute for the advice of your||
0026|006|Z|health care professional. Always ask your health care||
0026|007|Z|professional for complete information about this product and your||
0026|008|Z|specific health needs.||
0026|009|B|||
0026|010|T|ERGOTAMINE - SUBLINGUAL||
0026|011|F|(er-GOT-a-meen)||
0026|012|B|||
0026|013|C|COMMON BRAND NAME(S): Ergomar||
0026|014|B|||
0026|015|W|WARNING:  This medication has rarely caused a very serious lack||
0026|016|W|of blood flow to the hands and feet (peripheral ischemia) or to||
0026|017|W|the brain, which could cause a stroke. The risk is increased when||
0026|018|W|this medication is taken with other drugs that can affect the||
0026|019|W|removal of ergotamine from your body. Examples include azole||
0026|020|W|antifungals (such as ketoconazole, itraconazole), cobicistat,||
0026|021|W|mifepristone, certain antidepressants (such as nefazodone),||
0026|022|W|macrolide antibiotics (such as clarithromycin, erythromycin,||
0026|023|W|troleandomycin), HIV protease inhibitors (such as nelfinavir,||
0026|024|W|indinavir), ritonavir, SSRIs (such as fluoxetine, paroxetine,||
0026|025|W|fluvoxamine), among others.||
0026|026|B|||
0026|027|U|USES:  This medication is used to treat or prevent a certain type||
0026|028|U|of headache (vascular headaches such as migraine headaches and||
0026|029|U|cluster headaches). Ergotamine helps narrow widened blood vessels||
0026|030|U|in the head, which reduces the throbbing effects of vascular||
0026|031|U|headaches.||
0026|032|B|||
0026|033|H|HOW TO USE:  Place one tablet under the tongue, allowing it to||
0026|034|H|dissolve as directed by your doctor. Do not chew or swallow the||
0026|035|H|tablet. Do not eat or drink while the tablet is dissolving in||
0026|036|H|your mouth.||
0026|037|H|   The dosage is based on your medical condition and response to||
0026|038|H|treatment. This medication works best if it is taken as the first||
0026|039|H|signs of the headache occur. If you wait until the headache has||
0026|040|H|worsened, the medication may not work as well.||
0026|041|H|   This medication usually should be taken only as needed. It is||
0026|042|H|not meant for long-term daily use. The maximum dose is 3 tablets||
0026|043|H|in any 24-hour period and 5 tablets in any 7-day period.||
0026|044|H|   If you suddenly stop using this medication, you may have||
0026|045|H|withdrawal symptoms (such as rebound headaches). This headache||
0026|046|H|may be different from your original headache and may last a few||
0026|047|H|days. To help prevent withdrawal, your doctor may lower your dose||
0026|048|H|slowly. Withdrawal is more likely if you have used ergotamine for||
0026|049|H|a long time (more than a few weeks) or in high doses. Tell your||
0026|050|H|doctor or pharmacist right away if you have withdrawal.||
0026|051|H|   If you are using drugs for migraine attacks on 10 or more days||
0026|052|H|each month, the drugs may actually make your headaches worse||
0026|053|H|(medication overuse headache). Do not use medications more often||
0026|054|H|or for longer than directed. Tell your doctor if you need to use||
0026|055|H|this medication more often, or if the medication is not working||
0026|056|H|as well, or if your headaches get worse.||
0026|057|B|||
0026|058|S|SIDE EFFECTS:  Nausea, vomiting, and dizziness may occur. If any||
0026|059|S|of these effects last or get worse, tell your doctor or||
0026|060|S|pharmacist promptly.||
0026|061|S|   Remember that this medication has been prescribed because your||
0026|062|S|doctor has judged that the benefit to you is greater than the||
0026|063|S|risk of side effects. Many people using this medication do not||
0026|064|S|have serious side effects.||
0026|065|S|   This medication may raise your blood pressure. Check your||
0026|066|S|blood pressure regularly and tell your doctor if the results are||
0026|067|S|high.||
0026|068|S|   Tell your doctor right away if you have any serious side||
0026|069|S|effects, including: slow/fast/irregular heartbeat,||
0026|070|S|tingling/pain/coldness in the fingers/toes, whitish||
0026|071|S|fingers/toes/nails, loss of feeling in the fingers/toes, bluish||
0026|072|S|hands/feet, muscle pain/weakness, severe stomach/abdominal pain,||
0026|073|S|lower back pain, signs of kidney problems (such as change in the||
0026|074|S|amount of urine).||
0026|075|S|   Get medical help right away if you have any very serious side||
0026|076|S|effects, including: chest pain, vision changes, confusion,||
0026|077|S|trouble speaking.||
0026|078|S|   A very serious allergic reaction to this drug is rare.||
0026|079|S|However, get medical help right away if you notice any symptoms||
0026|080|S|of a serious allergic reaction, including: rash, itching/swelling||
0026|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0026|082|S|breathing.||
0026|083|S|   This is not a complete list of possible side effects. If you||
0026|084|S|notice other effects not listed above, contact your doctor or||
0026|085|S|pharmacist.||
0026|086|S|   In the US -||
0026|087|S|   Call your doctor for medical advice about side effects. You||
0026|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0026|089|S|www.fda.gov/medwatch.||
0026|090|S|   In Canada - Call your doctor for medical advice about side||
0026|091|S|effects. You may report side effects to Health Canada at||
0026|092|S|1-866-234-2345.||
0026|093|B|||
0026|094|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0026|095|P|pharmacist if you are allergic to ergotamine; or to other ergot||
0026|096|P|alkaloids (such as dihydroergotamine); or if you have any other||
0026|097|P|allergies. This product may contain inactive ingredients, which||
0026|098|P|can cause allergic reactions or other problems. Talk to your||
0026|099|P|pharmacist for more details.||
0026|100|P|   Before using this medication, tell your doctor or pharmacist||
0026|101|P|your medical history, especially of: blood circulation disease||
0026|102|P|(such as peripheral vascular disease such as arteriosclerosis,||
0026|103|P|thrombophlebitis, Raynaud's disease), high blood pressure,||
0026|104|P|nutrient deficiency (malnutrition), heart/blood vessel disease||
0026|105|P|(such as coronary artery disease, stroke, recent heart attack),||
0026|106|P|liver disease, kidney disease, severe infection, severe itching,||
0026|107|P|smoking/tobacco use, diabetes.||
0026|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0026|109|P|can make you more dizzy. Do not drive, use machinery, or do||
0026|110|P|anything that needs alertness until you can do it safely. Limit||
0026|111|P|alcoholic beverages. Talk to your doctor if you are using||
0026|112|P|marijuana (cannabis). Remember that alcohol may be a cause of||
0026|113|P|headaches.||
0026|114|P|   Using tobacco/nicotine products while using this medication||
0026|115|P|can increase the risk of serious side effects such as heart||
0026|116|P|problems (including chest pain, fast/slow/irregular heartbeat)||
0026|117|P|and decreased blood flow to the brain/hands/feet. Do not use||
0026|118|P|tobacco while taking this medication. If you smoke, talk to your||
0026|119|P|doctor about how to stop smoking.||
0026|120|P|   Before having surgery, tell your doctor or dentist about all||
0026|121|P|the products you use (including prescription drugs,||
0026|122|P|nonprescription drugs, and herbal products).||
0026|123|P|   This medication must not be used during pregnancy. It may harm||
0026|124|P|an unborn baby. Discuss the use of reliable forms of birth||
0026|125|P|control (such as condoms, birth control pills) with your doctor.||
0026|126|P|If you become pregnant or think you may be pregnant, tell your||
0026|127|P|doctor right away.||
0026|128|P|   This drug may pass into breast milk and could have undesirable||
0026|129|P|effects on a nursing infant. Breastfeeding is not recommended||
0026|130|P|while using this drug. Consult your doctor before breastfeeding.||
0026|131|B|||
0026|132|I|DRUG INTERACTIONS:  See also Warning section.||
0026|133|I|   Drug interactions may change how your medications work or||
0026|134|I|increase your risk for serious side effects. This document does||
0026|135|I|not contain all possible drug interactions. Keep a list of all||
0026|136|I|the products you use (including prescription/nonprescription||
0026|137|I|drugs and herbal products) and share it with your doctor and||
0026|138|I|pharmacist. Do not start, stop, or change the dosage of any||
0026|139|I|medicines without your doctor's approval.||
0026|140|I|   If you also take "triptan" migraine drugs (such as||
0026|141|I|sumatriptan, rizatriptan), you will need to separate your||
0026|142|I|"triptan" dose from your dose of this medication to reduce the||
0026|143|I|risk of serious side effects. Ask your doctor how long you should||
0026|144|I|wait between your doses of these drugs.||
0026|145|I|   Some products have ingredients that could raise your heart||
0026|146|I|rate or blood pressure. Tell your pharmacist what products you||
0026|147|I|are using, and ask how to use them safely (especially||
0026|148|I|cough-and-cold products, bronchodilators, stimulants, diet aids,||
0026|149|I|or other migraine medications).||
0026|150|B|||
0026|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0026|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0026|153|O|poison control center right away. US residents can call||
0026|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0026|155|O|Symptoms of overdose may include: severe dizziness/drowsiness,||
0026|156|O|loss of feeling in the fingers/toes, rapid/weak heartbeat, bluish||
0026|157|O|hands/feet, seizures.||
0026|158|B|||
0026|159|N|NOTES:  Do not share this medication with others.||
0026|160|N|   Certain foods/beverages or food additives (such as red wine,||
0026|161|N|cheese, chocolate, monosodium glutamate, alcohol) as well as some||
0026|162|N|lifestyle patterns (such as irregular eating/sleeping habits,||
0026|163|N|stress) may bring about a migraine headache. Avoiding these||
0026|164|N|"triggers" may help decrease the frequency of migraine headaches.||
0026|165|N|Consult your doctor for more details.||
0026|166|B|||
0026|167|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0026|168|D|remember. If it is near the time of the next dose, skip the||
0026|169|D|missed dose. Take your next dose at the regular time. Do not||
0026|170|D|double the dose to catch up.||
0026|171|B|||
0026|172|R|STORAGE:  Store at room temperature away from light and heat. Do||
0026|173|R|not store in the bathroom. Keep all medications away from||
0026|174|R|children and pets.||
0026|175|R|   Do not flush medications down the toilet or pour them into a||
0026|176|R|drain unless instructed to do so. Properly discard this product||
0026|177|R|when it is expired or no longer needed. Consult your pharmacist||
0026|178|R|or local waste disposal company.||
0026|179|B|||
0026|180|A|Information last revised May 2025.||
0026|181|A|Copyright(c) 2025 First Databank, Inc.||
0026|182|B|||
0027|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0027|002|Z|does NOT have all possible information about this product. This||
0027|003|Z|information does not assure that this product is safe, effective,||
0027|004|Z|or appropriate for you. This information is not individual||
0027|005|Z|medical advice and does not substitute for the advice of your||
0027|006|Z|health care professional. Always ask your health care||
0027|007|Z|professional for complete information about this product and your||
0027|008|Z|specific health needs.||
0027|009|B|||
0027|010|T|ESTROGENS - ORAL||
0027|011|F|(ES-troe-jenz)||
0027|012|B|||
0027|013|W|WARNING:  Estrogens, either used alone or with another hormone||
0027|014|W|(progestin), have rarely caused very serious side effects.||
0027|015|W|Discuss the risks and benefits of hormone treatment with your||
0027|016|W|doctor. Estrogens should not be used to prevent heart disease or||
0027|017|W|dementia.||
0027|018|W|   Estrogens can increase the risk of cancer of the uterus||
0027|019|W|(endometrial cancer). Taking a progestin as directed by your||
0027|020|W|doctor can help decrease this risk. Tell your doctor right away||
0027|021|W|if you have any unusual vaginal bleeding.||
0027|022|W|   In postmenopausal women, estrogens, taken with or without a||
0027|023|W|progestin, increase the risk of cancer of the breast/ovaries,||
0027|024|W|stroke, dementia, and serious blood clots. When used along with a||
0027|025|W|progestin, estrogens also increase the risk of heart disease||
0027|026|W|(such as heart attacks).||
0027|027|W|   The risk for serious side effects may depend on the dose of||
0027|028|W|estrogen and the length of time it is used. This medication||
0027|029|W|should be used at the lowest effective dose and for the shortest||
0027|030|W|amount of time. Discuss the use of this medication with your||
0027|031|W|doctor and check with him/her regularly (for example, every 3 to||
0027|032|W|6 months) to see if you still need to take this medication. If||
0027|033|W|you will be taking this medication long-term, you should have||
0027|034|W|regular complete physical exams (for example, once a year) as||
0027|035|W|directed by your doctor. See also Notes section.||
0027|036|B|||
0027|037|U|USES:  This medication is a hormone (estrogen). It is used by||
0027|038|U|women to help reduce symptoms of menopause (such as hot flashes,||
0027|039|U|vaginal dryness). These symptoms are caused by the body making||
0027|040|U|less estrogen. If you are using this medication to treat symptoms||
0027|041|U|only in and around the vagina, products applied directly inside||
0027|042|U|the vagina should be considered before medications that are taken||
0027|043|U|by mouth, absorbed through the skin, or injected.||
0027|044|U|   Certain estrogen products may also be used by women after||
0027|045|U|menopause to prevent bone loss (osteoporosis). However, there are||
0027|046|U|other medications (such as raloxifene, bisphosphonates including||
0027|047|U|alendronate) that are also effective in preventing bone loss and||
0027|048|U|may be safer. These medications should be considered for use||
0027|049|U|before estrogen treatment.||
0027|050|U|   Certain estrogen products may also be used by men and women to||
0027|051|U|treat cancers (certain types of prostate cancer, breast cancer||
0027|052|U|that has spread to other parts of the body) and by women who are||
0027|053|U|not able to produce enough estrogen (for example, due to||
0027|054|U|hypogonadism, primary ovarian failure).||
0027|055|B|||
0027|056|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0027|057|H|from your pharmacist before you start using this medication and||
0027|058|H|each time you get a refill. If you have any questions, ask your||
0027|059|H|doctor or pharmacist.||
0027|060|H|   Take this medication by mouth with or without food as directed||
0027|061|H|by your doctor. You may take it with food or right after a meal||
0027|062|H|to prevent stomach upset.||
0027|063|H|   If you are taking the extended-release tablets, do not crush,||
0027|064|H|chew, or dissolve them. Doing so can release all of the drug at||
0027|065|H|once, increasing the risk of side effects. Swallow the tablets||
0027|066|H|whole.||
0027|067|H|   The dosage is based on your medical condition and response to||
0027|068|H|treatment.||
0027|069|H|   Take this medication regularly to get the most benefit from||
0027|070|H|it. To help you remember, take it at the same time(s) each day as||
0027|071|H|directed. Follow your dosing schedule carefully. Do not increase||
0027|072|H|your dose or take this medication more often or for a longer time||
0027|073|H|than directed.||
0027|074|H|   Tell your doctor if your condition does not get better or if||
0027|075|H|it gets worse.||
0027|076|B|||
0027|077|S|SIDE EFFECTS:  See also Warning section.||
0027|078|S|   Stomach upset, nausea/vomiting, bloating, breast tenderness,||
0027|079|S|headache, or weight changes may occur. If any of these effects||
0027|080|S|last or get worse, tell your doctor or pharmacist promptly.||
0027|081|S|   Tell your doctor promptly if you see the tablet in your stool.||
0027|082|S|   Remember that this medication has been prescribed because your||
0027|083|S|doctor has judged that the benefit to you is greater than the||
0027|084|S|risk of side effects. Many people using this medication do not||
0027|085|S|have serious side effects.||
0027|086|S|   Tell your doctor right away if you have any serious side||
0027|087|S|effects, including: nausea/vomiting that doesn't stop,||
0027|088|S|mental/mood changes (such as depression, memory loss), breast||
0027|089|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
0027|090|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
0027|091|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
0027|092|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
0027|093|S|increased thirst/urination.||
0027|094|S|   This medication may rarely cause serious (sometimes fatal)||
0027|095|S|problems from blood clots (such as heart attack, stroke, blood||
0027|096|S|clots in the lungs or legs). Get medical help right away if you||
0027|097|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
0027|098|S|headaches, weakness on one side of the body, confusion, trouble||
0027|099|S|speaking, sudden vision changes, pain/swelling/warmth in the||
0027|100|S|groin/calf, shortness of breath/rapid breathing, sudden||
0027|101|S|dizziness/fainting.||
0027|102|S|   A very serious allergic reaction to this product is rare.||
0027|103|S|However, get medical help right away if you notice any symptoms||
0027|104|S|of a serious allergic reaction, including: rash, itching/swelling||
0027|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0027|106|S|breathing.||
0027|107|S|   This is not a complete list of possible side effects. If you||
0027|108|S|notice other effects not listed above, contact your doctor or||
0027|109|S|pharmacist.||
0027|110|S|   In the US -||
0027|111|S|   Call your doctor for medical advice about side effects. You||
0027|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0027|113|S|www.fda.gov/medwatch.||
0027|114|S|   In Canada - Call your doctor for medical advice about side||
0027|115|S|effects. You may report side effects to Health Canada at||
0027|116|S|1-866-234-2345.||
0027|117|B|||
0027|118|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0027|119|P|pharmacist if you are allergic to it; or if you have any other||
0027|120|P|allergies. This product may contain inactive ingredients, which||
0027|121|P|can cause allergic reactions or other problems. Talk to your||
0027|122|P|pharmacist for more details.||
0027|123|P|   Before using this medication, tell your doctor or pharmacist||
0027|124|P|your medical history, especially of: vaginal bleeding of unknown||
0027|125|P|cause, certain cancers (such as breast cancer, cancer of the||
0027|126|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
0027|127|P|heart attack), liver disease, kidney disease, family medical||
0027|128|P|history (especially breast lumps, cancer, blood clots), family or||
0027|129|P|personal history of a certain swelling disorder (angioedema),||
0027|130|P|blood clotting disorders (such as protein C or protein S||
0027|131|P|deficiency), high blood pressure, diabetes, high||
0027|132|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
0027|133|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
0027|134|P|calcium in the blood), a certain hormone problem||
0027|135|P|(hypoparathyroidism), uterus problems (such as fibroids,||
0027|136|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
0027|137|P|headaches, a certain blood disorder (porphyria), mental/mood||
0027|138|P|disorders (such as dementia, depression).||
0027|139|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
0027|140|P|further increases your risk of stroke, blood clots, high blood||
0027|141|P|pressure, and heart attack, especially in women older than 35.||
0027|142|P|   Tell your doctor if you just had or will be having surgery, or||
0027|143|P|if you will be confined to a chair or bed for a long time (such||
0027|144|P|as a long plane flight). These conditions increase your risk of||
0027|145|P|getting blood clots, especially if you are taking an estrogen||
0027|146|P|product. You may need to stop this medication for a time or take||
0027|147|P|special precautions.||
0027|148|P|   This medication may cause blotchy, dark areas on your face and||
0027|149|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0027|150|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0027|151|P|wear protective clothing when outdoors.||
0027|152|P|   If you are nearsighted or wear contact lenses, you may develop||
0027|153|P|vision problems or trouble wearing your contact lenses. Contact||
0027|154|P|your eye doctor if these problems occur.||
0027|155|P|   Children may be more sensitive to the side effects of this||
0027|156|P|drug. It may affect their growth/development. Discuss the||
0027|157|P|possible effects of this medication with the doctor, and monitor||
0027|158|P|your child's growth periodically.||
0027|159|P|   This medication should not be used during pregnancy. If you||
0027|160|P|become pregnant or think you may be pregnant, tell your doctor||
0027|161|P|right away.||
0027|162|P|   This medication passes into breast milk. Consult your doctor||
0027|163|P|before breastfeeding.||
0027|164|B|||
0027|165|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0027|166|I|medications work or increase your risk for serious side effects.||
0027|167|I|This document does not contain all possible drug interactions.||
0027|168|I|Keep a list of all the products you use (including||
0027|169|I|prescription/nonprescription drugs and herbal products) and share||
0027|170|I|it with your doctor and pharmacist. Do not start, stop, or change||
0027|171|I|the dosage of any medicines without your doctor's approval.||
0027|172|I|   Some products that may interact with this drug include:||
0027|173|I|aromatase inhibitors (such as anastrozole, exemestane,||
0027|174|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
0027|175|I|tamoxifen, toremifene, tranexamic acid.||
0027|176|I|   This medication may interfere with certain lab tests (such as||
0027|177|I|metyrapone test), possibly causing false test results. Make sure||
0027|178|I|lab personnel and all your doctors know you use this drug.||
0027|179|B|||
0027|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0027|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0027|182|O|poison control center right away. US residents can call||
0027|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0027|184|O|Symptoms of overdose may include: severe nausea/vomiting, unusual||
0027|185|O|vaginal bleeding.||
0027|186|B|||
0027|187|N|NOTES:  Do not share this medication with others.||
0027|188|N|   Regular complete physical exams which include lab and/or||
0027|189|N|medical tests (such as blood pressure, breast exam/mammogram,||
0027|190|N|pelvic exam, Pap smear) should be done while you are taking this||
0027|191|N|medication. Follow your doctor's instructions for examining your||
0027|192|N|breasts, and report any lumps right away. Keep all medical and||
0027|193|N|lab appointments. Consult your doctor for more details.||
0027|194|N|   Preventing or controlling high blood pressure, high||
0027|195|N|cholesterol, and diabetes can help to reduce your chances of||
0027|196|N|heart disease and stroke. Lifestyle changes that can help to||
0027|197|N|control or prevent these diseases include reducing stress, eating||
0027|198|N|a low fat/salt diet, losing weight if overweight, exercising||
0027|199|N|regularly, and stopping smoking. Keep your mind active with||
0027|200|N|mental exercises (such as reading, solving crossword puzzles) to||
0027|201|N|help prevent dementia. Talk to your doctor about lifestyle||
0027|202|N|changes that might benefit you.||
0027|203|N|   Lifestyle changes that may help reduce hot flashes include||
0027|204|N|stopping smoking, dressing lightly or in layers,||
0027|205|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
0027|206|N|reducing stress, and exercising regularly.||
0027|207|N|   Lifestyle changes that help promote healthy bones include||
0027|208|N|increasing weight-bearing exercise, stopping smoking, limiting||
0027|209|N|alcohol, and eating well-balanced meals that contain adequate||
0027|210|N|calcium and vitamin D. Since you may also need to take calcium||
0027|211|N|and vitamin D supplements and make lifestyle changes, consult||
0027|212|N|your doctor for specific advice.||
0027|213|B|||
0027|214|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0027|215|D|remember. If it is near the time of the next dose, skip the||
0027|216|D|missed dose. Take your next dose at the regular time. Do not||
0027|217|D|double the dose to catch up.||
0027|218|B|||
0027|219|R|STORAGE:  Store at room temperature away from light and moisture.||
0027|220|R|Do not store in the bathroom. Keep all medications away from||
0027|221|R|children and pets.||
0027|222|R|   Do not flush medications down the toilet or pour them into a||
0027|223|R|drain unless instructed to do so. Properly discard this product||
0027|224|R|when it is expired or no longer needed. Consult your pharmacist||
0027|225|R|or local waste disposal company.||
0027|226|B|||
0027|227|A|Information last revised October 2024.||
0027|228|A|Copyright(c) 2025 First Databank, Inc.||
0027|229|B|||
0028|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0028|002|Z|does NOT have all possible information about this product. This||
0028|003|Z|information does not assure that this product is safe, effective,||
0028|004|Z|or appropriate for you. This information is not individual||
0028|005|Z|medical advice and does not substitute for the advice of your||
0028|006|Z|health care professional. Always ask your health care||
0028|007|Z|professional for complete information about this product and your||
0028|008|Z|specific health needs.||
0028|009|B|||
0028|010|T|ETHAMBUTOL - ORAL||
0028|011|F|(eth-AM-bue-tol)||
0028|012|B|||
0028|013|C|COMMON BRAND NAME(S): Myambutol||
0028|014|B|||
0028|015|U|USES:  Ethambutol is used with other medications to treat||
0028|016|U|tuberculosis (TB). Ethambutol is an antibiotic and works by||
0028|017|U|stopping the growth of bacteria.||
0028|018|U|   This antibiotic treats only bacterial infections. It will not||
0028|019|U|work for viral infections (such as common cold, flu). Using any||
0028|020|U|antibiotic when it is not needed can cause it to not work for||
0028|021|U|future infections.||
0028|022|B|||
0028|023|V|OTHER USES:  This section contains uses of this drug that are not||
0028|024|V|listed in the approved professional labeling for the drug but||
0028|025|V|that may be prescribed by your health care professional. Use this||
0028|026|V|drug for a condition that is listed in this section only if it||
0028|027|V|has been so prescribed by your health care professional.||
0028|028|V|   This drug may also be used for a certain serious infection||
0028|029|V|(Mycobacterium avium complex-MAC). It may also be used to reduce||
0028|030|V|the risk of MAC infection from occurring again in people with||
0028|031|V|advanced HIV disease.||
0028|032|B|||
0028|033|H|HOW TO USE:  Take this medication by mouth with or without food||
0028|034|H|as directed by your doctor, usually once daily. This medication||
0028|035|H|may sometimes be taken twice weekly. Take this medication exactly||
0028|036|H|as directed by your doctor. The dosage is based on your age,||
0028|037|H|weight, medical condition, and response to treatment.||
0028|038|H|   If you also take antacids that contain aluminum, take this||
0028|039|H|medication at least 4 hours before the antacid.||
0028|040|H|   For the best effect, take this antibiotic at evenly spaced||
0028|041|H|times. To help you remember, take this medication at the same||
0028|042|H|time(s) every day.||
0028|043|H|   Continue to take this medication (and other TB medications)||
0028|044|H|until the full prescribed amount is finished, even if symptoms||
0028|045|H|disappear. Stopping the medication too early or skipping doses||
0028|046|H|may result in a return of the infection and cause the infection||
0028|047|H|to be more difficult to treat (resistant).||
0028|048|H|   Tell your doctor if your condition lasts or gets worse.||
0028|049|B|||
0028|050|S|SIDE EFFECTS:  Headache, loss of appetite, upset stomach, or||
0028|051|S|nausea/vomiting may occur. If any of these effects last or get||
0028|052|S|worse, tell your doctor or pharmacist promptly.||
0028|053|S|   Remember that this medication has been prescribed because your||
0028|054|S|doctor has judged that the benefit to you is greater than the||
0028|055|S|risk of side effects. Many people using this medication do not||
0028|056|S|have serious side effects.||
0028|057|S|   Tell your doctor right away if you have any serious side||
0028|058|S|effects, including: vision changes (such as blurred/decreased||
0028|059|S|vision, color blindness), symptoms of liver disease (such as||
0028|060|S|nausea/vomiting that doesn't stop, unusual tiredness/weakness,||
0028|061|S|severe stomach/abdominal pain, yellowing eyes/skin, dark urine),||
0028|062|S|numbness/tingling of arms/legs, toe/joint pain, mental/mood||
0028|063|S|disorders (such as confusion, hallucinations), signs of a new||
0028|064|S|infection (such as sore throat that doesn't go away, fever), easy||
0028|065|S|bleeding/bruising.||
0028|066|S|   A very serious allergic reaction to this drug is rare.||
0028|067|S|However, get medical help right away if you notice any symptoms||
0028|068|S|of a serious allergic reaction, including: rash, itching/swelling||
0028|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0028|070|S|breathing.||
0028|071|S|   This is not a complete list of possible side effects. If you||
0028|072|S|notice other effects not listed above, contact your doctor or||
0028|073|S|pharmacist.||
0028|074|S|   In the US -||
0028|075|S|   Call your doctor for medical advice about side effects. You||
0028|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0028|077|S|www.fda.gov/medwatch.||
0028|078|S|   In Canada - Call your doctor for medical advice about side||
0028|079|S|effects. You may report side effects to Health Canada at||
0028|080|S|1-866-234-2345.||
0028|081|B|||
0028|082|P|PRECAUTIONS:  Before taking ethambutol, tell your doctor or||
0028|083|P|pharmacist if you are allergic to it; or if you have any other||
0028|084|P|allergies. This product may contain inactive ingredients, which||
0028|085|P|can cause allergic reactions or other problems. Talk to your||
0028|086|P|pharmacist for more details.||
0028|087|P|   Before using this medication, tell your doctor or pharmacist||
0028|088|P|your medical history, especially of: eye problems (such as optic||
0028|089|P|neuritis, cataracts, diabetic retinopathy), liver disease, kidney||
0028|090|P|disease, alcohol use.||
0028|091|P|   Ethambutol may cause live bacterial vaccines (such as typhoid||
0028|092|P|vaccine) to not work well. Tell your health care professional||
0028|093|P|that you are using ethambutol before having any||
0028|094|P|immunizations/vaccinations.||
0028|095|P|   Before having surgery, tell your doctor or dentist about all||
0028|096|P|the products you use (including prescription drugs,||
0028|097|P|nonprescription drugs, and herbal products).||
0028|098|P|   Alcohol may increase the risk of liver disease. Avoid||
0028|099|P|alcoholic beverages while using this medication.||
0028|100|P|   During pregnancy, this medication should be used only when||
0028|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
0028|102|P|   This medication passes into breast milk but is unlikely to||
0028|103|P|harm a nursing infant. If you have HIV, breast milk may transmit||
0028|104|P|HIV. Consult your doctor before breastfeeding.||
0028|105|B|||
0028|106|I|DRUG INTERACTIONS:  See also How to Use section.||
0028|107|I|   Drug interactions may change how your medications work or||
0028|108|I|increase your risk for serious side effects. This document does||
0028|109|I|not contain all possible drug interactions. Keep a list of all||
0028|110|I|the products you use (including prescription/nonprescription||
0028|111|I|drugs and herbal products) and share it with your doctor and||
0028|112|I|pharmacist. Do not start, stop, or change the dosage of any||
0028|113|I|medicines without your doctor's approval.||
0028|114|B|||
0028|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0028|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0028|117|O|poison control center right away. US residents can call||
0028|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0028|119|B|||
0028|120|N|NOTES:  Do not share this medication with others.||
0028|121|N|   Lab and/or medical tests (such as sputum test, eye/vision||
0028|122|N|exams, kidney/liver function, complete blood count) should be||
0028|123|N|done while you are taking this medication. Keep all medical and||
0028|124|N|lab appointments. Consult your doctor for more details.||
0028|125|B|||
0028|126|D|MISSED DOSE:  It is important to take each dose of this||
0028|127|D|medication as scheduled. If you miss a dose, take it as soon as||
0028|128|D|you remember. If it is near the time of the next dose, skip the||
0028|129|D|missed dose. Take your next dose at the regular time. Do not||
0028|130|D|double the dose to catch up.||
0028|131|B|||
0028|132|R|STORAGE:  Store at room temperature away from light and moisture.||
0028|133|R|Do not store in the bathroom. Keep all medications away from||
0028|134|R|children and pets.||
0028|135|R|   Do not flush medications down the toilet or pour them into a||
0028|136|R|drain unless instructed to do so. Properly discard this product||
0028|137|R|when it is expired or no longer needed. Consult your pharmacist||
0028|138|R|or local waste disposal company.||
0028|139|B|||
0028|140|A|Information last revised May 2024.||
0028|141|A|Copyright(c) 2025 First Databank, Inc.||
0028|142|B|||
0029|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0029|002|Z|does NOT have all possible information about this product. This||
0029|003|Z|information does not assure that this product is safe, effective,||
0029|004|Z|or appropriate for you. This information is not individual||
0029|005|Z|medical advice and does not substitute for the advice of your||
0029|006|Z|health care professional. Always ask your health care||
0029|007|Z|professional for complete information about this product and your||
0029|008|Z|specific health needs.||
0029|009|B|||
0029|010|T|ETHOSUXIMIDE - ORAL||
0029|011|F|(ETH-oh-SUX-i-mide)||
0029|012|B|||
0029|013|C|COMMON BRAND NAME(S): Zarontin||
0029|014|B|||
0029|015|U|USES:  This medication is used alone or with other medications to||
0029|016|U|prevent and control a certain type of seizure (absence or petit||
0029|017|U|mal seizure). It works by controlling the abnormal electrical||
0029|018|U|activity in the brain that occurs during a seizure.||
0029|019|B|||
0029|020|H|HOW TO USE:  Read the Medication Guide provided by your||
0029|021|H|pharmacist before you start taking this medication and each time||
0029|022|H|you get a refill. If you have any questions, ask your doctor or||
0029|023|H|pharmacist.||
0029|024|H|   Take this medication by mouth with or without food as directed||
0029|025|H|by your doctor, usually once or twice daily.||
0029|026|H|   If you are using the liquid form of this medication, carefully||
0029|027|H|measure the dose using a special measuring device/spoon. Do not||
0029|028|H|use a household spoon because you may not get the correct dose.||
0029|029|H|   The dosage is based on your age, medical condition, blood||
0029|030|H|levels of ethosuximide, and response to treatment. Children's||
0029|031|H|dosage may also be based on weight.||
0029|032|H|   It is very important to follow your doctor's dosing||
0029|033|H|instructions exactly. Your doctor will start you on a low dose||
0029|034|H|and slowly increase your dose. It may take several weeks or||
0029|035|H|months to reach the best dose for you and to get the full benefit||
0029|036|H|from this medication. Use this medication regularly in order to||
0029|037|H|get the most benefit from it. To help you remember, use it at the||
0029|038|H|same time(s) each day.||
0029|039|H|   Do not stop taking this medication without consulting your||
0029|040|H|doctor. Some conditions may become worse when the drug is||
0029|041|H|suddenly stopped. Your dose may need to be gradually decreased.||
0029|042|H|   Tell your doctor if your condition does not get better or if||
0029|043|H|it gets worse.||
0029|044|B|||
0029|045|S|SIDE EFFECTS:  Drowsiness, dizziness, tiredness, headache,||
0029|046|S|stomach upset, loss of appetite, nausea, vomiting, weight loss,||
0029|047|S|diarrhea, or loss of coordination may occur. If any of these||
0029|048|S|effects last or get worse, tell your doctor or pharmacist||
0029|049|S|promptly.||
0029|050|S|   Remember that this medication has been prescribed because your||
0029|051|S|doctor has judged that the benefit to you is greater than the||
0029|052|S|risk of side effects. Many people using this medication do not||
0029|053|S|have serious side effects.||
0029|054|S|   A small number of people who take anticonvulsants for any||
0029|055|S|condition (such as seizure, bipolar disorder, pain) may||
0029|056|S|experience depression, suicidal thoughts/attempts, or other||
0029|057|S|mental/mood problems. Tell your doctor right away if you or your||
0029|058|S|family/caregiver notice any unusual/sudden changes in your mood,||
0029|059|S|thoughts, or behavior including signs of depression, suicidal||
0029|060|S|thoughts/attempts, thoughts about harming yourself.||
0029|061|S|   Tell your doctor right away if you have any serious side||
0029|062|S|effects, including: fainting, aching swollen joints, severe||
0029|063|S|tiredness, easy bruising/bleeding, pink/bloody urine, rapid||
0029|064|S|breathing.||
0029|065|S|   A very serious allergic reaction to this drug is rare.||
0029|066|S|However, get medical help right away if you notice any symptoms||
0029|067|S|of a serious allergic reaction, including: fever, swollen lymph||
0029|068|S|nodes, rash, itching/swelling (especially of the||
0029|069|S|face/tongue/throat), severe dizziness, trouble breathing.||
0029|070|S|   This is not a complete list of possible side effects. If you||
0029|071|S|notice other effects not listed above, contact your doctor or||
0029|072|S|pharmacist.||
0029|073|S|   In the US -||
0029|074|S|   Call your doctor for medical advice about side effects. You||
0029|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0029|076|S|www.fda.gov/medwatch.||
0029|077|S|   In Canada - Call your doctor for medical advice about side||
0029|078|S|effects. You may report side effects to Health Canada at||
0029|079|S|1-866-234-2345.||
0029|080|B|||
0029|081|P|PRECAUTIONS:  Before taking ethosuximide, tell your doctor or||
0029|082|P|pharmacist if you are allergic to it; or to methsuximide; or if||
0029|083|P|you have any other allergies. This product may contain inactive||
0029|084|P|ingredients, which can cause allergic reactions or other||
0029|085|P|problems. Talk to your pharmacist for more details.||
0029|086|P|   Before using this medication, tell your doctor or pharmacist||
0029|087|P|your medical history, especially of: liver disease, kidney||
0029|088|P|disease, mental/mood disorder (such as depression, psychosis).||
0029|089|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0029|090|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0029|091|P|machinery, or do anything that needs alertness until you can do||
0029|092|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0029|093|P|are using marijuana (cannabis).||
0029|094|P|   Liquid products may contain sugar and/or alcohol. Caution is||
0029|095|P|advised if you have diabetes, alcohol dependence, liver disease,||
0029|096|P|or any other condition that requires you to limit/avoid these||
0029|097|P|substances in your diet. Ask your doctor or pharmacist about||
0029|098|P|using this product safely.||
0029|099|P|   Older adults may be more sensitive to the side effects of this||
0029|100|P|drug, especially dizziness, loss of coordination, or fainting.||
0029|101|P|These side effects can increase the risk of falling.||
0029|102|P|   During pregnancy, this medication should be used only when||
0029|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
0029|104|P|   This medication passes into breast milk, but is unlikely to||
0029|105|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0029|106|B|||
0029|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0029|108|I|medications work or increase your risk for serious side effects.||
0029|109|I|This document does not contain all possible drug interactions.||
0029|110|I|Keep a list of all the products you use (including||
0029|111|I|prescription/nonprescription drugs and herbal products) and share||
0029|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
0029|113|I|the dosage of any medicines without your doctor's approval.||
0029|114|I|   A product that may interact with this drug is: orlistat.||
0029|115|I|   Tell your doctor or pharmacist if you are taking other||
0029|116|I|products that cause drowsiness, including alcohol, marijuana||
0029|117|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0029|118|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0029|119|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0029|120|I|codeine).||
0029|121|I|   Check the labels on all your medicines (such as allergy or||
0029|122|I|cough-and-cold products) because they may contain ingredients||
0029|123|I|that cause drowsiness. Ask your pharmacist about using those||
0029|124|I|products safely.||
0029|125|B|||
0029|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0029|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0029|128|O|poison control center right away. US residents can call||
0029|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0029|130|O|Symptoms of overdose may include: slow/shallow breathing, severe||
0029|131|O|drowsiness, loss of consciousness.||
0029|132|B|||
0029|133|N|NOTES:  Do not share this medication with others.||
0029|134|N|   Lab and/or medical tests (such as ethosuximide blood levels,||
0029|135|N|complete blood count, kidney/liver function) should be done while||
0029|136|N|you are taking this medication. Keep all medical and lab||
0029|137|N|appointments. Consult your doctor for more details.||
0029|138|B|||
0029|139|D|MISSED DOSE:  It is important to take each dose at the scheduled||
0029|140|D|time. If you miss a dose, take it as soon as you remember. If it||
0029|141|D|is near the time of the next dose, skip the missed dose. Take||
0029|142|D|your next dose at the regular time. Do not double the dose to||
0029|143|D|catch up.||
0029|144|B|||
0029|145|R|STORAGE:  Store at room temperature away from light and moisture.||
0029|146|R|Do not freeze the liquid form of this medication. Do not store in||
0029|147|R|the bathroom. Keep all medications away from children and pets.||
0029|148|R|   Do not flush medications down the toilet or pour them into a||
0029|149|R|drain unless instructed to do so. Properly discard this product||
0029|150|R|when it is expired or no longer needed. Consult your pharmacist||
0029|151|R|or local waste disposal company.||
0029|152|B|||
0029|153|M|MEDICAL ALERT:  Your condition can cause complications in a||
0029|154|M|medical emergency. For information about enrolling in MedicAlert,||
0029|155|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0029|156|B|||
0029|157|A|Information last revised October 2024.||
0029|158|A|Copyright(c) 2025 First Databank, Inc.||
0029|159|B|||
0031|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0031|002|Z|does NOT have all possible information about this product. This||
0031|003|Z|information does not assure that this product is safe, effective,||
0031|004|Z|or appropriate for you. This information is not individual||
0031|005|Z|medical advice and does not substitute for the advice of your||
0031|006|Z|health care professional. Always ask your health care||
0031|007|Z|professional for complete information about this product and your||
0031|008|Z|specific health needs.||
0031|009|B|||
0031|010|T|EZETIMIBE/SIMVASTATIN - ORAL||
0031|011|F|(e-ZET-i-mibe/SIM-va-STAT-in)||
0031|012|B|||
0031|013|C|COMMON BRAND NAME(S): Vytorin||
0031|014|B|||
0031|015|U|USES:  This combination medication is used along with a proper||
0031|016|U|diet to help lower "bad" cholesterol and fats (such as LDL,||
0031|017|U|triglycerides) and raise "good" cholesterol (HDL) in the blood.||
0031|018|U|Ezetimibe works by reducing the amount of cholesterol your body||
0031|019|U|absorbs from your diet. Simvastatin belongs to a group of drugs||
0031|020|U|known as "statins." It works by reducing the amount of||
0031|021|U|cholesterol made by the liver.||
0031|022|U|   In addition to eating a proper diet (such as a||
0031|023|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
0031|024|U|help this medication work better include exercising, losing||
0031|025|U|weight if overweight, and stopping smoking. Consult your doctor||
0031|026|U|for more details.||
0031|027|U|   Lowering "bad" cholesterol and triglycerides and raising||
0031|028|U|"good" cholesterol decreases the risk of heart disease and helps||
0031|029|U|prevent strokes and heart attacks.||
0031|030|B|||
0031|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0031|032|H|from your pharmacist before you start taking this product and||
0031|033|H|each time you get a refill. If you have any questions, ask your||
0031|034|H|doctor or pharmacist.||
0031|035|H|   Take this medication by mouth with or without food as directed||
0031|036|H|by your doctor, usually once daily in the evening.||
0031|037|H|   The dosage is based on your medical condition, response to||
0031|038|H|treatment, age, and other medications you may be taking. Be sure||
0031|039|H|to tell your doctor and pharmacist about all the products you use||
0031|040|H|(including prescription drugs, nonprescription drugs, and herbal||
0031|041|H|products).||
0031|042|H|   The usual maximum dose for the simvastatin in this medication||
0031|043|H|is 40 milligrams a day. If you have been instructed by your||
0031|044|H|doctor to take more than 40 milligrams of simvastatin, continue||
0031|045|H|on that same dose. However, promptly talk with him or her about||
0031|046|H|the risks and benefits of your higher dose.||
0031|047|H|   Do not increase your dose or take this medication more often||
0031|048|H|than prescribed. Your condition will not improve any faster, and||
0031|049|H|the risk of serious side effects may be increased.||
0031|050|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0031|051|H|using this medication unless your doctor or pharmacist says you||
0031|052|H|may do so safely. Grapefruit can increase the chance of side||
0031|053|H|effects with this medicine. Ask your doctor or pharmacist for||
0031|054|H|more details.||
0031|055|H|   If you also take certain other drugs to lower your cholesterol||
0031|056|H|(bile acid-binding resins such as cholestyramine or colestipol),||
0031|057|H|take this product at least 2 hours before or at least 4 hours||
0031|058|H|after taking these medications. These medications can react with||
0031|059|H|this product, preventing its full absorption.||
0031|060|H|   Take this medication regularly in order to get the most||
0031|061|H|benefit from it. Remember to take it at the same time each day.||
0031|062|H|Keep taking this medication even if you feel well. Most people||
0031|063|H|with high cholesterol or triglycerides do not feel sick.||
0031|064|H|   It is very important to continue to follow your doctor's||
0031|065|H|advice about diet and exercise. It may take up to 4 weeks before||
0031|066|H|you get the full benefit of this drug.||
0031|067|B|||
0031|068|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0031|069|S|because your doctor has judged that the benefit to you is greater||
0031|070|S|than the risk of side effects. Many people using this medication||
0031|071|S|do not have serious side effects.||
0031|072|S|   A very small number of people taking simvastatin may have mild||
0031|073|S|memory problems or confusion. If these rare effects occur, talk||
0031|074|S|to your doctor.||
0031|075|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
0031|076|S|doctor about the benefits and risks.||
0031|077|S|   This drug may rarely cause muscle problems (which can rarely||
0031|078|S|lead to very serious conditions called rhabdomyolysis and||
0031|079|S|autoimmune myopathy). Older adults and Chinese people may be at||
0031|080|S|higher risk. Tell your doctor right away if you develop any of||
0031|081|S|these symptoms during treatment and if these symptoms last after||
0031|082|S|your doctor stops this drug: muscle pain/tenderness/weakness||
0031|083|S|(especially with fever or unusual tiredness), signs of kidney||
0031|084|S|problems (such as change in the amount of urine).||
0031|085|S|   This medication may rarely cause liver problems. Tell your||
0031|086|S|doctor right away if you develop symptoms of liver problems,||
0031|087|S|including: nausea/vomiting that doesn't stop, yellowing||
0031|088|S|eyes/skin, dark urine, stomach/abdominal pain.||
0031|089|S|   A very serious allergic reaction to this drug is rare.||
0031|090|S|However, get medical help right away if you notice any symptoms||
0031|091|S|of a serious allergic reaction, including: rash, itching/swelling||
0031|092|S|(especially of the face/tongue/throat), dizziness, trouble||
0031|093|S|breathing.||
0031|094|S|   This is not a complete list of possible side effects. If you||
0031|095|S|notice other effects not listed above, contact your doctor or||
0031|096|S|pharmacist.||
0031|097|S|   In the US -||
0031|098|S|   Call your doctor for medical advice about side effects. You||
0031|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0031|100|S|www.fda.gov/medwatch.||
0031|101|S|   In Canada - Call your doctor for medical advice about side||
0031|102|S|effects. You may report side effects to Health Canada at||
0031|103|S|1-866-234-2345.||
0031|104|B|||
0031|105|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0031|106|P|pharmacist if you are allergic to ezetimibe or simvastatin; or if||
0031|107|P|you have any other allergies. This product may contain inactive||
0031|108|P|ingredients, which can cause allergic reactions or other||
0031|109|P|problems. Talk to your pharmacist for more details.||
0031|110|P|   Before using this medication, tell your doctor or pharmacist||
0031|111|P|your medical history, especially of: liver disease, kidney||
0031|112|P|disease, alcohol use.||
0031|113|P|   Before having surgery, tell your doctor or dentist about all||
0031|114|P|the products you use (including prescription drugs,||
0031|115|P|nonprescription drugs, and herbal products).||
0031|116|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
0031|117|P|your risk for liver problems, especially when combined with this||
0031|118|P|product. Ask your doctor or pharmacist for more information.||
0031|119|P|   Older adults may be more sensitive to the side effects of this||
0031|120|P|medication, especially muscle problems.||
0031|121|P|   During pregnancy, this medication should be used only when||
0031|122|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0031|123|P|benefits with your doctor.||
0031|124|P|   Ezetimibe passes into breast milk. It is unknown if||
0031|125|P|simvastatin passes into breast milk. However, similar drugs pass||
0031|126|P|into breast milk. Breastfeeding is not recommended while using||
0031|127|P|this medication. Consult your doctor before breastfeeding.||
0031|128|B|||
0031|129|I|DRUG INTERACTIONS:  See also How To Use section.||
0031|130|I|   Drug interactions may change how your medications work or||
0031|131|I|increase your risk for serious side effects. This document does||
0031|132|I|not contain all possible drug interactions. Keep a list of all||
0031|133|I|the products you use (including prescription/nonprescription||
0031|134|I|drugs and herbal products) and share it with your doctor and||
0031|135|I|pharmacist. Do not start, stop, or change the dosage of any||
0031|136|I|medicines without your doctor's approval.||
0031|137|I|   Some products that may interact with this drug include: "blood||
0031|138|I|thinners" (such as warfarin), cyclosporine, danazol, daptomycin,||
0031|139|I|gemfibrozil.||
0031|140|I|   Other medications can affect the removal of simvastatin from||
0031|141|I|your body, which may affect how simvastatin works. Examples||
0031|142|I|include certain azole antifungals (such as itraconazole,||
0031|143|I|ketoconazole, posaconazole, voriconazole), cobicistat,||
0031|144|I|colchicine, macrolide antibiotics (such as clarithromycin,||
0031|145|I|erythromycin), nefazodone, HIV protease inhibitors (such as||
0031|146|I|nelfinavir), ritonavir, telithromycin, among others.||
0031|147|I|   Chinese people should not take niacin at doses used to lower||
0031|148|I|cholesterol (1 gram or more) when taking this medication. Doing||
0031|149|I|so may increase the risk of side effects (especially muscle||
0031|150|I|problems). Talk with your doctor for details.||
0031|151|I|   Do not take any red yeast rice products while you are taking||
0031|152|I|ezetimibe/simvastatin because some red yeast rice products may||
0031|153|I|also contain a statin called lovastatin. Taking||
0031|154|I|ezetimibe/simvastatin and red yeast rice products together can||
0031|155|I|increase your risk of serious muscle and liver problems.||
0031|156|B|||
0031|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0031|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0031|159|O|poison control center right away. US residents can call||
0031|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0031|161|B|||
0031|162|N|NOTES:  Do not share this medication with others.||
0031|163|N|   Lab and/or medical tests (such as blood||
0031|164|N|cholesterol/triglyceride levels, liver function) should be done||
0031|165|N|while you are taking this medication. Keep all medical and lab||
0031|166|N|appointments. Consult your doctor for more details.||
0031|167|B|||
0031|168|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0031|169|D|remember. If it is near the time of the next dose, skip the||
0031|170|D|missed dose. Take your next dose at the regular time. Do not||
0031|171|D|double the dose to catch up.||
0031|172|B|||
0031|173|R|STORAGE:  Store at room temperature away from light and moisture.||
0031|174|R|Do not store in the bathroom. Keep all medications away from||
0031|175|R|children and pets.||
0031|176|R|   Do not flush medications down the toilet or pour them into a||
0031|177|R|drain unless instructed to do so. Properly discard this product||
0031|178|R|when it is expired or no longer needed. Consult your pharmacist||
0031|179|R|or local waste disposal company.||
0031|180|B|||
0031|181|A|Information last revised July 2025.||
0031|182|A|Copyright(c) 2025 First Databank, Inc.||
0031|183|B|||
0032|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0032|002|Z|does NOT have all possible information about this product. This||
0032|003|Z|information does not assure that this product is safe, effective,||
0032|004|Z|or appropriate for you. This information is not individual||
0032|005|Z|medical advice and does not substitute for the advice of your||
0032|006|Z|health care professional. Always ask your health care||
0032|007|Z|professional for complete information about this product and your||
0032|008|Z|specific health needs.||
0032|009|B|||
0032|010|T|RIFAXIMIN - ORAL||
0032|011|F|(rif-AX-i-min)||
0032|012|B|||
0032|013|C|COMMON BRAND NAME(S): Xifaxan||
0032|014|B|||
0032|015|U|USES:  This medication is used to treat diarrhea caused by the||
0032|016|U|common bacteria known as E. coli ("traveler's diarrhea").||
0032|017|U|Rifaximin should not be used if you have a fever or bloody||
0032|018|U|diarrhea. It works by stopping the growth of bacteria.||
0032|019|U|   This antibiotic treats only bacterial infections. It will not||
0032|020|U|work for viral infections (such as common cold, flu). Using any||
0032|021|U|antibiotic when it is not needed can cause it to not work for||
0032|022|U|future infections.||
0032|023|U|   Rifaximin is also used to treat irritable bowel syndrome with||
0032|024|U|diarrhea. It is also used to prevent a brain problem caused by||
0032|025|U|liver disease (hepatic encephalopathy).||
0032|026|B|||
0032|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0032|028|H|from your pharmacist before you start taking rifaximin and each||
0032|029|H|time you get a refill. If you have any questions, ask your doctor||
0032|030|H|or pharmacist.||
0032|031|H|   The dosage is based on your medical condition and response to||
0032|032|H|treatment.||
0032|033|H|   To treat traveler's diarrhea, take this medication by mouth||
0032|034|H|with or without food as directed by your doctor, usually 3 times||
0032|035|H|a day (every 8 hours) for 3 days.||
0032|036|H|   To treat irritable bowel syndrome with diarrhea, take this||
0032|037|H|medication by mouth with or without food as directed by your||
0032|038|H|doctor, usually 3 times a day (every 8 hours) for 14 days.||
0032|039|H|   To prevent hepatic encephalopathy, take this medication by||
0032|040|H|mouth with or without food as directed by your doctor, usually 2||
0032|041|H|times a day (every 12 hours).||
0032|042|H|   For the best effect, take this antibiotic at evenly spaced||
0032|043|H|times. To help you remember, take this medication at the same||
0032|044|H|time(s) every day.||
0032|045|H|   For traveler's diarrhea, continue to take this medication||
0032|046|H|until the full prescribed amount is finished, even if symptoms||
0032|047|H|disappear after a few days. Stopping the medication too early may||
0032|048|H|result in a return of the infection.||
0032|049|H|   Tell your doctor if you are still having diarrhea after 1 to 2||
0032|050|H|days, if you have bloody diarrhea, or if you have a fever along||
0032|051|H|with the diarrhea. Tell your doctor if your condition does not||
0032|052|H|get better or if it gets worse.||
0032|053|B|||
0032|054|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0032|055|S|because your doctor has judged that the benefit to you is greater||
0032|056|S|than the risk of side effects. Many people using this medication||
0032|057|S|do not have serious side effects.||
0032|058|S|   This medication may rarely cause a severe intestinal condition||
0032|059|S|due to a bacteria called C. difficile. This condition may occur||
0032|060|S|during treatment or weeks to months after treatment has stopped.||
0032|061|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0032|062|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0032|063|S|stool.||
0032|064|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0032|065|S|products because they may make symptoms worse.||
0032|066|S|   A very serious allergic reaction to this drug is rare.||
0032|067|S|However, get medical help right away if you notice any symptoms||
0032|068|S|of a serious allergic reaction, including: rash, itching/swelling||
0032|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0032|070|S|breathing.||
0032|071|S|   This is not a complete list of possible side effects. If you||
0032|072|S|notice other effects not listed above, contact your doctor or||
0032|073|S|pharmacist.||
0032|074|S|   In the US -||
0032|075|S|   Call your doctor for medical advice about side effects. You||
0032|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0032|077|S|www.fda.gov/medwatch.||
0032|078|S|   In Canada - Call your doctor for medical advice about side||
0032|079|S|effects. You may report side effects to Health Canada at||
0032|080|S|1-866-234-2345.||
0032|081|B|||
0032|082|P|PRECAUTIONS:  Before taking rifaximin, tell your doctor or||
0032|083|P|pharmacist if you are allergic to it; or to other rifamycins||
0032|084|P|(rifampin, rifabutin); or if you have any other allergies. This||
0032|085|P|product may contain inactive ingredients, which can cause||
0032|086|P|allergic reactions or other problems. Talk to your pharmacist for||
0032|087|P|more details.||
0032|088|P|   Before using this medication, tell your doctor or pharmacist||
0032|089|P|your medical history.||
0032|090|P|   Rifaximin may cause live bacterial vaccines (such as typhoid||
0032|091|P|vaccine) to not work well. Tell your health care professional||
0032|092|P|that you are using rifaximin before having any||
0032|093|P|immunizations/vaccinations.||
0032|094|P|   Before having surgery, tell your doctor or dentist about all||
0032|095|P|the products you use (including prescription drugs,||
0032|096|P|nonprescription drugs, and herbal products).||
0032|097|P|   During pregnancy, this medication should be used only when||
0032|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
0032|099|P|   It is unknown if this drug passes into breast milk. Consult||
0032|100|P|your doctor before breastfeeding.||
0032|101|B|||
0032|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0032|103|I|medications work or increase your risk for serious side effects.||
0032|104|I|This document does not contain all possible drug interactions.||
0032|105|I|Keep a list of all the products you use (including||
0032|106|I|prescription/nonprescription drugs and herbal products) and share||
0032|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
0032|108|I|the dosage of any medicines without your doctor's approval.||
0032|109|B|||
0032|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0032|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0032|112|O|poison control center right away. US residents can call||
0032|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0032|114|B|||
0032|115|N|NOTES:  Do not share this medication with others.||
0032|116|N|   This medication has been prescribed for your current condition||
0032|117|N|only. Do not use it later for another infection unless your||
0032|118|N|doctor tells you to.||
0032|119|B|||
0032|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0032|121|D|remember. If it is near the time of the next dose, skip the||
0032|122|D|missed dose. Take your next dose at the regular time. Do not||
0032|123|D|double the dose to catch up.||
0032|124|B|||
0032|125|R|STORAGE:  Store at room temperature away from light and moisture.||
0032|126|R|Do not store in the bathroom. Keep all medications away from||
0032|127|R|children and pets.||
0032|128|R|   Do not flush medications down the toilet or pour them into a||
0032|129|R|drain unless instructed to do so. Properly discard this product||
0032|130|R|when it is expired or no longer needed. Consult your pharmacist||
0032|131|R|or local waste disposal company.||
0032|132|B|||
0032|133|A|Information last revised October 2024.||
0032|134|A|Copyright(c) 2025 First Databank, Inc.||
0032|135|B|||
0033|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0033|002|Z|does NOT have all possible information about this product. This||
0033|003|Z|information does not assure that this product is safe, effective,||
0033|004|Z|or appropriate for you. This information is not individual||
0033|005|Z|medical advice and does not substitute for the advice of your||
0033|006|Z|health care professional. Always ask your health care||
0033|007|Z|professional for complete information about this product and your||
0033|008|Z|specific health needs.||
0033|009|B|||
0033|010|T|NIZATIDINE - ORAL||
0033|011|F|(nye-ZA-ti-deen)||
0033|012|B|||
0033|013|C|COMMON BRAND NAME(S): Axid||
0033|014|B|||
0033|015|U|USES:  Nizatidine is used to treat ulcers of the stomach and||
0033|016|U|intestines and prevent them from coming back after they have||
0033|017|U|healed. This medication is also used to treat certain stomach and||
0033|018|U|throat (esophagus) problems (such as erosive esophagitis,||
0033|019|U|gastroesophageal reflux disease-GERD). It works by decreasing the||
0033|020|U|amount of acid your stomach makes. It relieves symptoms such as||
0033|021|U|cough that doesn't go away, stomach pain, heartburn, and||
0033|022|U|difficulty swallowing. Nizatidine belongs to a class of drugs||
0033|023|U|known as H2 blockers.||
0033|024|B|||
0033|025|V|OTHER USES:  This section contains uses of this drug that are not||
0033|026|V|listed in the approved professional labeling for the drug but||
0033|027|V|that may be prescribed by your health care professional. Use this||
0033|028|V|drug for a condition that is listed in this section only if it||
0033|029|V|has been so prescribed by your health care professional.||
0033|030|V|   This drug may also be used for other stomach/intestinal||
0033|031|V|problems caused by too much stomach acid.||
0033|032|B|||
0033|033|H|HOW TO USE:  Take this medication by mouth with or without food||
0033|034|H|as directed by your doctor, usually once or twice a day. If you||
0033|035|H|are taking this medication once daily, it is usually taken right||
0033|036|H|before bedtime. If you are using the liquid form of this||
0033|037|H|medication, carefully measure the dose using a special measuring||
0033|038|H|device/spoon. Do not use a household spoon because you may not||
0033|039|H|get the correct dose.||
0033|040|H|   The dosage and length of treatment are based on your medical||
0033|041|H|condition and response to treatment. Follow your doctor's||
0033|042|H|instructions carefully.||
0033|043|H|   If needed, antacids may be taken along with this medication.||
0033|044|H|   Use this medication regularly to get the most benefit from it.||
0033|045|H|To help you remember, take it at the same time(s) each day. Do||
0033|046|H|not increase your dose or use this drug more often or for longer||
0033|047|H|than prescribed. Your condition will not improve any faster, and||
0033|048|H|your risk of side effects will increase. Continue to take this||
0033|049|H|medication for the prescribed length of treatment even if you are||
0033|050|H|feeling better.||
0033|051|H|   Tell your doctor if your condition does not get better or if||
0033|052|H|it gets worse.||
0033|053|B|||
0033|054|S|SIDE EFFECTS:  Headache or diarrhea may occur. If either of these||
0033|055|S|effects lasts or gets worse, tell your doctor or pharmacist||
0033|056|S|promptly.||
0033|057|S|   Remember that this medication has been prescribed because your||
0033|058|S|doctor has judged that the benefit to you is greater than the||
0033|059|S|risk of side effects. Many people using this medication do not||
0033|060|S|have serious side effects.||
0033|061|S|   Tell your doctor right away if you have any serious side||
0033|062|S|effects, including: nausea/vomiting that doesn't stop, loss of||
0033|063|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0033|064|S|urine, confusion, breast swelling/soreness in males, easy||
0033|065|S|bruising/bleeding, signs of infection (such as sore throat that||
0033|066|S|doesn't go away, fever, chills), fast/pounding heartbeat, unusual||
0033|067|S|tiredness.||
0033|068|S|   A very serious allergic reaction to this drug is rare.||
0033|069|S|However, get medical help right away if you notice any symptoms||
0033|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0033|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0033|072|S|breathing.||
0033|073|S|   This is not a complete list of possible side effects. If you||
0033|074|S|notice other effects not listed above, contact your doctor or||
0033|075|S|pharmacist.||
0033|076|S|   In the US -||
0033|077|S|   Call your doctor for medical advice about side effects. You||
0033|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0033|079|S|www.fda.gov/medwatch.||
0033|080|S|   In Canada - Call your doctor for medical advice about side||
0033|081|S|effects. You may report side effects to Health Canada at||
0033|082|S|1-866-234-2345.||
0033|083|B|||
0033|084|P|PRECAUTIONS:  Before taking nizatidine, tell your doctor or||
0033|085|P|pharmacist if you are allergic to it; or to other H2 blockers||
0033|086|P|(cimetidine, famotidine, ranitidine); or if you have any other||
0033|087|P|allergies. This product may contain inactive ingredients, which||
0033|088|P|can cause allergic reactions or other problems. Talk to your||
0033|089|P|pharmacist for more details.||
0033|090|P|   Before using this medication, tell your doctor or pharmacist||
0033|091|P|your medical history, especially of: immune system problems,||
0033|092|P|kidney problems, liver problems, certain lung diseases (such as||
0033|093|P|chronic obstructive pulmonary disease-COPD), other stomach||
0033|094|P|problems (such as tumors).||
0033|095|P|   Some symptoms may actually be signs of a more serious||
0033|096|P|condition. Get medical help right away if you have: heartburn||
0033|097|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
0033|098|P|pain (especially with shortness of breath, unusual sweating),||
0033|099|P|unexplained weight loss.||
0033|100|P|   Before having surgery, tell your doctor or dentist about all||
0033|101|P|the products you use (including prescription drugs,||
0033|102|P|nonprescription drugs, and herbal products).||
0033|103|P|   During pregnancy, this medication should be used only when||
0033|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
0033|105|P|   This medication passes into breast milk. Consult your doctor||
0033|106|P|before breastfeeding.||
0033|107|B|||
0033|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0033|109|I|medications work or increase your risk for serious side effects.||
0033|110|I|This document does not contain all possible drug interactions.||
0033|111|I|Keep a list of all the products you use (including||
0033|112|I|prescription/nonprescription drugs and herbal products) and share||
0033|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
0033|114|I|the dosage of any medicines without your doctor's approval.||
0033|115|I|   Some products need stomach acid so that the body can absorb||
0033|116|I|them properly. Nizatidine decreases stomach acid, so it may||
0033|117|I|change how well these products work. Some affected products||
0033|118|I|include atazanavir, dasatinib, certain azole antifungals (such as||
0033|119|I|itraconazole, ketoconazole), levoketoconazole, pazopanib,||
0033|120|I|sparsentan, among others.||
0033|121|I|   Do not take this medication with other products that contain||
0033|122|I|nizatidine or other H2 blockers (cimetidine, famotidine,||
0033|123|I|ranitidine).||
0033|124|I|   This medication may interfere with certain lab tests (such as||
0033|125|I|urine protein tests), possibly causing false test results. Make||
0033|126|I|sure lab personnel and all your doctors know you use this drug.||
0033|127|B|||
0033|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0033|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0033|130|O|poison control center right away. US residents can call||
0033|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0033|132|B|||
0033|133|N|NOTES:  Do not share this medication with others.||
0033|134|N|   Lifestyle changes such as stress reduction programs, stopping||
0033|135|N|smoking, limiting alcohol, and diet changes (such as avoiding||
0033|136|N|caffeine and certain spices) may help this medication work||
0033|137|N|better. Talk to your doctor or pharmacist about lifestyle changes||
0033|138|N|that might benefit you.||
0033|139|N|   Lab and/or medical tests (such as endoscopy, kidney function)||
0033|140|N|may be done while you are taking this medication. Keep all||
0033|141|N|medical and lab appointments. Consult your doctor for more||
0033|142|N|details.||
0033|143|B|||
0033|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0033|145|D|remember. If it is near the time of the next dose, skip the||
0033|146|D|missed dose. Take your next dose at the regular time. Do not||
0033|147|D|double the dose to catch up.||
0033|148|B|||
0033|149|R|STORAGE:  Store at room temperature away from light and moisture.||
0033|150|R|Do not store in the bathroom. Keep all medications away from||
0033|151|R|children and pets.||
0033|152|R|   Do not flush medications down the toilet or pour them into a||
0033|153|R|drain unless instructed to do so. Properly discard this product||
0033|154|R|when it is expired or no longer needed. Consult your pharmacist||
0033|155|R|or local waste disposal company.||
0033|156|B|||
0033|157|A|Information last revised October 2024.||
0033|158|A|Copyright(c) 2025 First Databank, Inc.||
0033|159|B|||
0034|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0034|002|Z|does NOT have all possible information about this product. This||
0034|003|Z|information does not assure that this product is safe, effective,||
0034|004|Z|or appropriate for you. This information is not individual||
0034|005|Z|medical advice and does not substitute for the advice of your||
0034|006|Z|health care professional. Always ask your health care||
0034|007|Z|professional for complete information about this product and your||
0034|008|Z|specific health needs.||
0034|009|B|||
0034|010|T|HALOPERIDOL - ORAL||
0034|011|F|(HAL-oh-PER-i-dol)||
0034|012|B|||
0034|013|C|COMMON BRAND NAME(S): Haldol||
0034|014|B|||
0034|015|W|WARNING:  There may be a slightly increased risk of serious,||
0034|016|W|possibly fatal side effects (such as heart failure,||
0034|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
0034|018|W|by older adults with dementia. This medication is not approved||
0034|019|W|for the treatment of dementia-related behavior problems. Discuss||
0034|020|W|the risks and benefits of this medication, as well as other||
0034|021|W|effective and possibly safer treatments for dementia-related||
0034|022|W|behavior problems, with the doctor.||
0034|023|B|||
0034|024|U|USES:  This medication is used to treat certain mental/mood||
0034|025|U|disorders (such as schizophrenia, schizoaffective disorders).||
0034|026|U|Haloperidol is also used to treat uncontrolled movements and||
0034|027|U|outbursts of words/sounds related to Tourette's syndrome. It is||
0034|028|U|also used by hyperactive children for severe behavior problems||
0034|029|U|when other treatments or medication have not worked. Haloperidol||
0034|030|U|belongs to a class of drugs known as antipsychotics. It works by||
0034|031|U|helping to restore the balance of certain natural substances in||
0034|032|U|the brain.||
0034|033|B|||
0034|034|V|OTHER USES:  This section contains uses of this drug that are not||
0034|035|V|listed in the approved professional labeling for the drug but||
0034|036|V|that may be prescribed by your health care professional. Use this||
0034|037|V|drug for a condition that is listed in this section only if it||
0034|038|V|has been so prescribed by your health care professional.||
0034|039|V|   Sometimes, this drug may be used for short periods of time by||
0034|040|V|hospitalized patients who have severe behavior problems or||
0034|041|V|confusion. This drug may also be used for nausea and vomiting due||
0034|042|V|to cancer treatment.||
0034|043|B|||
0034|044|H|HOW TO USE:  Take this medication by mouth with or without food||
0034|045|H|as directed by your doctor. If you are using the liquid form of||
0034|046|H|the medication, use the measuring dropper provided in the package||
0034|047|H|to measure your dose. If you do not have the dropper, ask your||
0034|048|H|pharmacist for a measured oral syringe so that your dose will be||
0034|049|H|correct.||
0034|050|H|   The dosage is based on your medical condition and response to||
0034|051|H|treatment. Use this medication regularly in order to get the most||
0034|052|H|benefit from it. To help you remember, use it at the same time(s)||
0034|053|H|each day.||
0034|054|H|   Do not stop taking this medication without consulting your||
0034|055|H|doctor. Some conditions may become worse when the drug is||
0034|056|H|suddenly stopped. Your dose may need to be gradually reduced.||
0034|057|H|   Tell your doctor if your symptoms do not get better or if they||
0034|058|H|get worse.||
0034|059|B|||
0034|060|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, difficulty||
0034|061|S|urinating, sleep disturbances, headache, or anxiety may occur. If||
0034|062|S|any of these effects last or get worse, tell your doctor or||
0034|063|S|pharmacist promptly.||
0034|064|S|   Dizziness and lightheadedness can increase the risk of||
0034|065|S|falling. Get up slowly when rising from a sitting or lying||
0034|066|S|position.||
0034|067|S|   Tell your doctor right away if any of these side effects||
0034|068|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
0034|069|S|mask-like expression of the face, drooling/trouble swallowing, or||
0034|070|S|shuffling walk. Your doctor may prescribe another medication to||
0034|071|S|decrease these side effects.||
0034|072|S|   Remember that this medication has been prescribed because your||
0034|073|S|doctor has judged that the benefit to you is greater than the||
0034|074|S|risk of side effects. Many people using this medication do not||
0034|075|S|have serious side effects.||
0034|076|S|   This medication may rarely cause a condition known as tardive||
0034|077|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0034|078|S|your doctor right away if you develop any facial/muscle twitching||
0034|079|S|such as tongue thrusting, chewing movements, puffing or puckering||
0034|080|S|of your mouth, or uncontrollable shaking.||
0034|081|S|   Tell your doctor right away if you have any serious side||
0034|082|S|effects, including: nausea/vomiting that doesn't stop,||
0034|083|S|stomach/abdominal pain, yellowing of eyes/skin, seizures, signs||
0034|084|S|of infection (such as sore throat that doesn't go away, fever,||
0034|085|S|chills).||
0034|086|S|   Get medical help right away if you have any very serious side||
0034|087|S|effects, including: slow heartbeat, severe dizziness, chest pain,||
0034|088|S|fainting.||
0034|089|S|   This medication may rarely cause a very serious condition||
0034|090|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0034|091|S|right away if you have any of the following symptoms: fever,||
0034|092|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
0034|093|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
0034|094|S|signs of kidney problems (such as change in the amount of urine).||
0034|095|S|   In rare cases, haloperidol may increase your level of a||
0034|096|S|certain chemical made by the body (prolactin). For females, this||
0034|097|S|increase in prolactin may result in unwanted breast milk,||
0034|098|S|missed/stopped periods, or difficulty becoming pregnant. For||
0034|099|S|males, it may result in decreased sexual ability, inability to||
0034|100|S|produce sperm, or enlarged breasts. If you develop any of these||
0034|101|S|symptoms, tell your doctor right away.||
0034|102|S|   Rarely, males may have a painful or prolonged erection lasting||
0034|103|S|4 or more hours. If this occurs, stop using this drug and get||
0034|104|S|medical help right away, or permanent problems could occur.||
0034|105|S|   A very serious allergic reaction to this drug is rare.||
0034|106|S|However, get medical help right away if you notice any symptoms||
0034|107|S|of a serious allergic reaction, including: rash, itching/swelling||
0034|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0034|109|S|breathing.||
0034|110|S|   This is not a complete list of possible side effects. If you||
0034|111|S|notice other effects not listed above, contact your doctor or||
0034|112|S|pharmacist.||
0034|113|S|   In the US -||
0034|114|S|   Call your doctor for medical advice about side effects. You||
0034|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0034|116|S|www.fda.gov/medwatch.||
0034|117|S|   In Canada - Call your doctor for medical advice about side||
0034|118|S|effects. You may report side effects to Health Canada at||
0034|119|S|1-866-234-2345.||
0034|120|B|||
0034|121|P|PRECAUTIONS:  Before taking haloperidol, tell your doctor or||
0034|122|P|pharmacist if you are allergic to it; or if you have any other||
0034|123|P|allergies. This product may contain inactive ingredients, which||
0034|124|P|can cause allergic reactions or other problems. Talk to your||
0034|125|P|pharmacist for more details.||
0034|126|P|   Before using this medication, tell your doctor or pharmacist||
0034|127|P|your medical history, especially of: a certain severe nervous||
0034|128|P|system problem (severe CNS depression), Parkinson's disease,||
0034|129|P|bipolar disorder, difficulty urinating (for example, due to||
0034|130|P|prostate problems), glaucoma, heart problems (such as angina),||
0034|131|P|overactive thyroid (hyperthyroidism), seizures, low white blood||
0034|132|P|cell count.||
0034|133|P|   Haloperidol may cause a condition that affects the heart||
0034|134|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0034|135|P|serious (rarely fatal) fast/irregular heartbeat and other||
0034|136|P|symptoms (such as severe dizziness, fainting) that need medical||
0034|137|P|attention right away.||
0034|138|P|   The risk of QT prolongation may be increased if you have||
0034|139|P|certain medical conditions or are taking other drugs that may||
0034|140|P|cause QT prolongation. Before using haloperidol, tell your doctor||
0034|141|P|or pharmacist of all the drugs you take and if you have any of||
0034|142|P|the following conditions: certain heart problems (heart failure,||
0034|143|P|slow heartbeat, QT prolongation in the EKG), family history of||
0034|144|P|certain heart problems (QT prolongation in the EKG, sudden||
0034|145|P|cardiac death).||
0034|146|P|   Low levels of potassium or magnesium in the blood may also||
0034|147|P|increase your risk of QT prolongation. This risk may increase if||
0034|148|P|you use certain drugs (such as diuretics/"water pills") or if you||
0034|149|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0034|150|P|Talk to your doctor about using haloperidol safely.||
0034|151|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0034|152|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0034|153|P|machinery, or do anything that needs alertness until you can do||
0034|154|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0034|155|P|are using marijuana (cannabis).||
0034|156|P|   Before having surgery, tell your doctor or dentist about all||
0034|157|P|the products you use (including prescription drugs,||
0034|158|P|nonprescription drugs, and herbal products).||
0034|159|P|   This medication may make you sweat less, making you more||
0034|160|P|likely to get heat stroke. Avoid doing things that may cause you||
0034|161|P|to overheat, such as hard work or exercise in hot weather, or||
0034|162|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0034|163|P|and dress lightly. If you overheat, quickly look for a place to||
0034|164|P|cool down and rest. Get medical help right away if you have a||
0034|165|P|fever that does not go away, mental/mood changes, headache, or||
0034|166|P|dizziness.||
0034|167|P|   Children may be more sensitive to the side effects of this||
0034|168|P|drug, especially uncontrolled movements.||
0034|169|P|   Older adults may be more sensitive to the side effects of this||
0034|170|P|drug, especially drowsiness, dizziness, lightheadedness,||
0034|171|P|difficulty urinating, and heart effects such as QT prolongation||
0034|172|P|(see above). Drowsiness, dizziness, and lightheadedness can||
0034|173|P|increase the risk of falling.||
0034|174|P|   During pregnancy, this medication should be used only when||
0034|175|P|clearly needed. Babies born to mothers who have used this drug||
0034|176|P|during the last 3 months of pregnancy may rarely develop symptoms||
0034|177|P|including muscle stiffness or shakiness, drowsiness,||
0034|178|P|feeding/breathing difficulties, or constant crying. If you notice||
0034|179|P|any of these symptoms in your newborn especially during their||
0034|180|P|first month, tell the doctor right away.||
0034|181|P|   Since untreated mental/mood problems (such as schizophrenia,||
0034|182|P|schizoaffective disorders) can be a serious condition, do not||
0034|183|P|stop taking this medication unless directed by your doctor. If||
0034|184|P|you are planning pregnancy, become pregnant, or think you may be||
0034|185|P|pregnant, immediately discuss with your doctor the benefits and||
0034|186|P|risks of using this medication during pregnancy.||
0034|187|P|   This drug passes into breast milk and could have undesirable||
0034|188|P|effects on a nursing infant. Consult your doctor before||
0034|189|P|breastfeeding.||
0034|190|B|||
0034|191|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0034|192|I|medications work or increase your risk for serious side effects.||
0034|193|I|This document does not contain all possible drug interactions.||
0034|194|I|Keep a list of all the products you use (including||
0034|195|I|prescription/nonprescription drugs and herbal products) and share||
0034|196|I|it with your doctor and pharmacist. Do not start, stop, or change||
0034|197|I|the dosage of any medicines without your doctor's approval.||
0034|198|I|   Some products that may interact with this drug include:||
0034|199|I|cabergoline, ketoconazole, lithium, methyldopa, paroxetine,||
0034|200|I|pergolide.||
0034|201|I|   Many drugs besides haloperidol may affect the heart rhythm (QT||
0034|202|I|prolongation), including amiodarone, dofetilide, pimozide,||
0034|203|I|quinidine, sotalol, procainamide, macrolide antibiotics (such as||
0034|204|I|erythromycin), among others. Before using haloperidol, report all||
0034|205|I|medications you are currently using to your doctor or pharmacist.||
0034|206|I|   Tell your doctor or pharmacist if you are taking other||
0034|207|I|products that cause drowsiness such as opioid pain or cough||
0034|208|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0034|209|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0034|210|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0034|211|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0034|212|I|diphenhydramine).||
0034|213|I|   Check the labels on all your medicines (such as allergy or||
0034|214|I|cough-and-cold products) because they may contain ingredients||
0034|215|I|that cause drowsiness. Ask your pharmacist about using those||
0034|216|I|products safely.||
0034|217|B|||
0034|218|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0034|219|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0034|220|O|poison control center right away. US residents can call||
0034|221|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0034|222|B|||
0034|223|N|NOTES:  Do not share this medication with others.||
0034|224|B|||
0034|225|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0034|226|D|remember. If it is near the time of the next dose, skip the||
0034|227|D|missed dose. Take your next dose at the regular time. Do not||
0034|228|D|double the dose to catch up.||
0034|229|B|||
0034|230|R|STORAGE:  Store at room temperature away from light and moisture.||
0034|231|R|Do not store in the bathroom. Keep all medications away from||
0034|232|R|children and pets.||
0034|233|R|   Do not flush medications down the toilet or pour them into a||
0034|234|R|drain unless instructed to do so. Properly discard this product||
0034|235|R|when it is expired or no longer needed. Consult your pharmacist||
0034|236|R|or local waste disposal company.||
0034|237|B|||
0034|238|A|Information last revised April 2025.||
0034|239|A|Copyright(c) 2025 First Databank, Inc.||
0034|240|B|||
0035|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0035|002|Z|does NOT have all possible information about this product. This||
0035|003|Z|information does not assure that this product is safe, effective,||
0035|004|Z|or appropriate for you. This information is not individual||
0035|005|Z|medical advice and does not substitute for the advice of your||
0035|006|Z|health care professional. Always ask your health care||
0035|007|Z|professional for complete information about this product and your||
0035|008|Z|specific health needs.||
0035|009|B|||
0035|010|T|HYDRALAZINE - ORAL||
0035|011|F|(hye-DRAL-a-zeen)||
0035|012|B|||
0035|013|C|COMMON BRAND NAME(S): Apresoline||
0035|014|B|||
0035|015|U|USES:  Hydralazine is used with or without other medications to||
0035|016|U|treat high blood pressure. Lowering high blood pressure helps||
0035|017|U|prevent strokes, heart attacks, and kidney problems. Hydralazine||
0035|018|U|is called a vasodilator. It works by relaxing blood vessels so||
0035|019|U|blood can flow through the body more easily.||
0035|020|B|||
0035|021|V|OTHER USES:  This section contains uses of this drug that are not||
0035|022|V|listed in the approved professional labeling for the drug but||
0035|023|V|that may be prescribed by your health care professional. Use this||
0035|024|V|drug for a condition that is listed in this section only if it||
0035|025|V|has been so prescribed by your health care professional.||
0035|026|V|   This drug may also be used for heart failure.||
0035|027|B|||
0035|028|H|HOW TO USE:  Take this medication by mouth with or without food||
0035|029|H|as directed by your doctor, usually 2 to 4 times daily. The||
0035|030|H|dosage is based on your medical condition and response to||
0035|031|H|treatment. Your doctor may start you at a low dose and gradually||
0035|032|H|increase your dose. Follow your doctor's instructions carefully.||
0035|033|H|   Use this medication regularly to get the most benefit from it.||
0035|034|H|To help you remember, take it at the same times each day. Keep||
0035|035|H|taking this medication even if you feel well. Most people with||
0035|036|H|high blood pressure do not feel sick. It may take up to several||
0035|037|H|weeks before you get the full benefit of this drug.||
0035|038|H|   Do not stop taking this medication without consulting your||
0035|039|H|doctor. Some conditions may become worse when the drug is||
0035|040|H|suddenly stopped. Your dose may need to be gradually decreased.||
0035|041|H|   Tell your doctor if your condition does not get better or if||
0035|042|H|it gets worse (your blood pressure readings remain high or||
0035|043|H|increase).||
0035|044|B|||
0035|045|S|SIDE EFFECTS:  Headache, pounding/fast heartbeat, loss of||
0035|046|S|appetite, nausea, vomiting, diarrhea, or dizziness may occur as||
0035|047|S|your body adjusts to the medication. If any of these effects last||
0035|048|S|or get worse, tell your doctor or pharmacist promptly.||
0035|049|S|   To reduce the risk of dizziness, get up slowly when rising||
0035|050|S|from a sitting or lying position.||
0035|051|S|   Remember that this medication has been prescribed because your||
0035|052|S|doctor has judged that the benefit to you is greater than the||
0035|053|S|risk of side effects. Many people using this medication do not||
0035|054|S|have serious side effects.||
0035|055|S|   This medication may rarely cause nerve problems. Tell your||
0035|056|S|doctor promptly if you experience numbness or tingling. Your||
0035|057|S|doctor may recommend a vitamin B6 supplement (pyridoxine).||
0035|058|S|   Tell your doctor right away if you have any serious side||
0035|059|S|effects, including: severe tiredness, aching/swollen joints, rash||
0035|060|S|on nose and cheeks, swollen lymph nodes, signs of kidney problems||
0035|061|S|(such as change in the amount of urine, bloody/pink urine), signs||
0035|062|S|of infection (such as sore throat that doesn't go away, fever,||
0035|063|S|chills), easy bruising/bleeding.||
0035|064|S|   Get medical help right away if you have any very serious side||
0035|065|S|effects, including: chest/jaw/left arm pain.||
0035|066|S|   A very serious allergic reaction to this drug is rare.||
0035|067|S|However, get medical help right away if you notice any symptoms||
0035|068|S|of a serious allergic reaction, including: rash, itching/swelling||
0035|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0035|070|S|breathing.||
0035|071|S|   This is not a complete list of possible side effects. If you||
0035|072|S|notice other effects not listed above, contact your doctor or||
0035|073|S|pharmacist.||
0035|074|S|   In the US -||
0035|075|S|   Call your doctor for medical advice about side effects. You||
0035|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0035|077|S|www.fda.gov/medwatch.||
0035|078|S|   In Canada - Call your doctor for medical advice about side||
0035|079|S|effects. You may report side effects to Health Canada at||
0035|080|S|1-866-234-2345.||
0035|081|B|||
0035|082|P|PRECAUTIONS:  Before taking hydralazine, tell your doctor or||
0035|083|P|pharmacist if you are allergic to it; or if you have any other||
0035|084|P|allergies. This product may contain inactive ingredients, which||
0035|085|P|can cause allergic reactions or other problems. Talk to your||
0035|086|P|pharmacist for more details.||
0035|087|P|   Before using this medication, tell your doctor or pharmacist||
0035|088|P|your medical history, especially of: heart problems (such as||
0035|089|P|coronary artery disease, recent heart attack, rheumatic heart||
0035|090|P|disease of the mitral valve), blood vessel problems, previous||
0035|091|P|stroke, kidney problems.||
0035|092|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0035|093|P|can make you more dizzy. Do not drive, use machinery, or do||
0035|094|P|anything that needs alertness until you can do it safely. Limit||
0035|095|P|alcoholic beverages. Talk to your doctor if you are using||
0035|096|P|marijuana (cannabis).||
0035|097|P|   Before having surgery, tell your doctor or dentist about all||
0035|098|P|the products you use (including prescription drugs,||
0035|099|P|nonprescription drugs, and herbal products).||
0035|100|P|   Older adults may be more sensitive to the side effects of this||
0035|101|P|medication, especially dizziness, which can increase the risk of||
0035|102|P|falls.||
0035|103|P|   During pregnancy, this medication should be used only when||
0035|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
0035|105|P|   This medication passes into breast milk, but is unlikely to||
0035|106|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0035|107|B|||
0035|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0035|109|I|medications work or increase your risk for serious side effects.||
0035|110|I|This document does not contain all possible drug interactions.||
0035|111|I|Keep a list of all the products you use (including||
0035|112|I|prescription/nonprescription drugs and herbal products) and share||
0035|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
0035|114|I|the dosage of any medicines without your doctor's approval.||
0035|115|I|   Some products that may interact with this drug are: MAO||
0035|116|I|inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue,||
0035|117|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0035|118|I|selegiline, tranylcypromine).||
0035|119|I|   Some products have ingredients that could raise your heart||
0035|120|I|rate or blood pressure or worsen your heart failure. Tell your||
0035|121|I|pharmacist what products you are using, and ask how to use them||
0035|122|I|safely (especially cough-and-cold products, diet aids, or NSAIDs||
0035|123|I|such as ibuprofen/naproxen).||
0035|124|B|||
0035|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0035|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0035|127|O|poison control center right away. US residents can call||
0035|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0035|129|O|Symptoms of overdose may include: severe dizziness, fainting,||
0035|130|O|flushing, chest/jaw/left arm pain, irregular heartbeat.||
0035|131|B|||
0035|132|N|NOTES:  Do not share this medication with others.||
0035|133|N|   Lifestyle changes such as stress reduction programs, exercise,||
0035|134|N|and dietary changes may help this medication work better. Talk to||
0035|135|N|your doctor or pharmacist about lifestyle changes that might||
0035|136|N|benefit you.||
0035|137|N|   Lab and/or medical tests (such as complete blood count) may be||
0035|138|N|done while you are taking this medication. Keep all medical and||
0035|139|N|lab appointments. Consult your doctor for more details.||
0035|140|N|   Have your blood pressure checked regularly while taking this||
0035|141|N|medication. Learn how to monitor your own blood pressure, and||
0035|142|N|share the readings with your doctor.||
0035|143|B|||
0035|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0035|145|D|remember. If it is near the time of the next dose, skip the||
0035|146|D|missed dose. Take your next dose at the regular time. Do not||
0035|147|D|double the dose to catch up.||
0035|148|B|||
0035|149|R|STORAGE:  Store at room temperature away from light and moisture.||
0035|150|R|Do not store in the bathroom. Keep all medications away from||
0035|151|R|children and pets.||
0035|152|R|   Do not flush medications down the toilet or pour them into a||
0035|153|R|drain unless instructed to do so. Properly discard this product||
0035|154|R|when it is expired or no longer needed. Consult your pharmacist||
0035|155|R|or local waste disposal company.||
0035|156|B|||
0035|157|A|Information last revised April 2025.||
0035|158|A|Copyright(c) 2025 First Databank, Inc.||
0035|159|B|||
0037|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0037|002|Z|does NOT have all possible information about this product. This||
0037|003|Z|information does not assure that this product is safe, effective,||
0037|004|Z|or appropriate for you. This information is not individual||
0037|005|Z|medical advice and does not substitute for the advice of your||
0037|006|Z|health care professional. Always ask your health care||
0037|007|Z|professional for complete information about this product and your||
0037|008|Z|specific health needs.||
0037|009|B|||
0037|010|T|INSULIN ISOPHANE SUSPENSION (PORK) - INJECTION||
0037|011|F|(IN-su-lin EYE-soe-fane)||
0037|012|B|||
0037|013|U|USES:  Insulin isophane is used with a proper diet and exercise||
0037|014|U|program to control high blood sugar in people with diabetes.||
0037|015|U|Controlling high blood sugar helps prevent kidney damage,||
0037|016|U|blindness, nerve problems, loss of limbs, and sexual function||
0037|017|U|problems. Proper control of diabetes may also lessen your risk of||
0037|018|U|a heart attack or stroke.||
0037|019|U|   This insulin is obtained from pigs and is similar to human||
0037|020|U|insulin. It replaces the insulin that your body would normally||
0037|021|U|make. It is an intermediate-acting insulin (isophane). It starts||
0037|022|U|to work more slowly but lasts longer than regular insulin.||
0037|023|U|Insulin isophane works by helping blood sugar (glucose) get into||
0037|024|U|cells so your body can use it for energy. Insulin isophane is||
0037|025|U|often used in combination with a shorter-acting insulin. It may||
0037|026|U|be used alone or with other oral diabetes drugs (such as||
0037|027|U|metformin).||
0037|028|B|||
0037|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0037|030|H|from your pharmacist before you start using this medication and||
0037|031|H|each time you get a refill. Ask your health care professional how||
0037|032|H|to prepare and use this medication. If you have any questions,||
0037|033|H|ask your doctor or pharmacist.||
0037|034|H|   Inject this medication under the skin as directed by your||
0037|035|H|doctor, usually once or twice a day. The injection is given in||
0037|036|H|the stomach area, the thigh, the buttocks, or the back of the||
0037|037|H|upper arm. Do not inject into a vein because very low blood sugar||
0037|038|H|(hypoglycemia) may occur.||
0037|039|H|   The dosage is based on your medical condition and response to||
0037|040|H|treatment. Measure each dose very carefully because even small||
0037|041|H|changes in the amount of insulin may have a large effect on your||
0037|042|H|blood sugar.||
0037|043|H|   Before using, gently roll the vial or cartridge, turning it||
0037|044|H|upside down and right side up several times to mix the||
0037|045|H|medication. Do not shake the container. Check this product for||
0037|046|H|particles or discoloration. If either is present, do not use the||
0037|047|H|insulin. Insulin isophane should look evenly cloudy/milky after||
0037|048|H|mixing. Do not use if you see clumps of white material, a||
0037|049|H|"frosty" appearance, or particles stuck to the sides of the vial||
0037|050|H|or cartridge.||
0037|051|H|   Before injecting each dose, clean the skin you are going to||
0037|052|H|inject into (the injection site) with rubbing alcohol. Change the||
0037|053|H|injection site each time to lessen injury under the skin (for||
0037|054|H|example, pits/lumps or thickened skin). Do not inject into skin||
0037|055|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
0037|056|H|not rub the injection site after a shot. Do not inject cold||
0037|057|H|insulin because this can be painful. The insulin container you||
0037|058|H|are currently using can be kept at room temperature. Learn how to||
0037|059|H|store and discard medical supplies safely.||
0037|060|H|   This product may be mixed only with certain other insulin||
0037|061|H|products such as insulin regular (pork). Always draw the insulin||
0037|062|H|regular into the syringe first, then follow with the||
0037|063|H|longer-acting insulin. Never inject a mixture of different||
0037|064|H|insulins into a vein. Consult your health care professional about||
0037|065|H|which products may be mixed, the proper method for mixing||
0037|066|H|insulin, and the proper way to inject mixtures of insulin. Do not||
0037|067|H|mix insulins if you are using an insulin pump.||
0037|068|H|   Do not change brands or types of insulin without directions on||
0037|069|H|how to do so from your doctor.||
0037|070|H|   Use this medication regularly to get the most benefit from it.||
0037|071|H|To help you remember, use it at the same time(s) each day.||
0037|072|H|   Tell your doctor if your condition does not get better or if||
0037|073|H|it gets worse (your blood sugar is too high or too low).||
0037|074|B|||
0037|075|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
0037|076|S|irritation) or weight gain may occur. If any of these effects||
0037|077|S|last or get worse, tell your doctor or pharmacist promptly.||
0037|078|S|   Remember that this medication has been prescribed because your||
0037|079|S|doctor has judged that the benefit to you is greater than the||
0037|080|S|risk of side effects. Many people using this medication do not||
0037|081|S|have serious side effects.||
0037|082|S|   Tell your doctor right away if you have any serious side||
0037|083|S|effects, including: signs of low potassium level in the blood||
0037|084|S|(such as muscle cramps, weakness, irregular heartbeat).||
0037|085|S|   This medication can cause low blood sugar (hypoglycemia). This||
0037|086|S|may occur if you do not get enough calories from food or if you||
0037|087|S|do unusually heavy exercise. Symptoms of low blood sugar include||
0037|088|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
0037|089|S|dizziness, or tingling hands/feet. It is a good habit to carry||
0037|090|S|glucose tablets or gel to treat low blood sugar. If you don't||
0037|091|S|have these reliable forms of glucose, rapidly raise your blood||
0037|092|S|sugar by eating a quick source of sugar such as table sugar,||
0037|093|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
0037|094|S|doctor right away about the reaction and the use of this product.||
0037|095|S|To help prevent low blood sugar, eat meals on a regular schedule,||
0037|096|S|and do not skip meals. Check with your doctor or pharmacist to||
0037|097|S|find out what you should do if you miss a meal.||
0037|098|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0037|099|S|thirst/urination. If these symptoms occur, tell your doctor right||
0037|100|S|away. Your doctor may need to adjust your diabetes medication,||
0037|101|S|exercise program, or diet.||
0037|102|S|   A very serious allergic reaction to this drug is rare.||
0037|103|S|However, get medical help right away if you notice any symptoms||
0037|104|S|of a serious allergic reaction, including: rash, itching/swelling||
0037|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0037|106|S|breathing.||
0037|107|S|   This is not a complete list of possible side effects. If you||
0037|108|S|notice other effects not listed above, contact your doctor or||
0037|109|S|pharmacist.||
0037|110|S|   In the US -||
0037|111|S|   Call your doctor for medical advice about side effects. You||
0037|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0037|113|S|www.fda.gov/medwatch.||
0037|114|S|   In Canada - Call your doctor for medical advice about side||
0037|115|S|effects. You may report side effects to Health Canada at||
0037|116|S|1-866-234-2345.||
0037|117|B|||
0037|118|P|PRECAUTIONS:  Before using insulin isophane, tell your doctor or||
0037|119|P|pharmacist if you are allergic to it; or to pork; or to other||
0037|120|P|insulins; or if you have any other allergies. This product may||
0037|121|P|contain inactive ingredients, which can cause allergic reactions||
0037|122|P|or other problems. Talk to your pharmacist for more details.||
0037|123|P|   Do not use this medication when you have low blood sugar||
0037|124|P|(hypoglycemia).||
0037|125|P|   Before using this medication, tell your doctor or pharmacist||
0037|126|P|your medical history, especially of: adrenal/pituitary gland||
0037|127|P|problems, kidney disease, liver disease, thyroid problems.||
0037|128|P|   You may experience blurred vision, dizziness, or drowsiness||
0037|129|P|due to extremely low or high blood sugar. Do not drive, use||
0037|130|P|machinery, or do anything that needs alertness or clear vision||
0037|131|P|until you can do it safely.||
0037|132|P|   Limit alcohol while using this medication because it can||
0037|133|P|increase your risk of developing low blood sugar.||
0037|134|P|   It may be harder to control your blood sugar when your body is||
0037|135|P|stressed (such as due to fever, infection, injury, or surgery).||
0037|136|P|Consult your doctor because this may require a change in your||
0037|137|P|treatment plan, medications, or blood sugar testing.||
0037|138|P|   Before having surgery, tell your doctor or dentist about all||
0037|139|P|the products you use (including prescription drugs,||
0037|140|P|nonprescription drugs, and herbal products).||
0037|141|P|   Check your blood sugar before and after exercise. You may need||
0037|142|P|a snack before exercising.||
0037|143|P|   If traveling across time zones, ask your doctor about how to||
0037|144|P|adjust your insulin schedule. Take extra insulin and supplies||
0037|145|P|with you.||
0037|146|P|   Older adults may be more sensitive to the side effects of this||
0037|147|P|drug, especially low blood sugar.||
0037|148|P|   Children may be more sensitive to the side effects of this||
0037|149|P|drug, especially low blood sugar.||
0037|150|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
0037|151|P|cause or worsen diabetes. Discuss a plan with your doctor for||
0037|152|P|managing your blood sugar while pregnant. Your doctor may change||
0037|153|P|your diabetes treatment during your pregnancy (such as diet and||
0037|154|P|medications including insulin).||
0037|155|P|   This medication passes into breast milk, but is unlikely to||
0037|156|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0037|157|P|Your insulin needs may change while breastfeeding.||
0037|158|B|||
0037|159|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0037|160|I|medications work or increase your risk for serious side effects.||
0037|161|I|This document does not contain all possible drug interactions.||
0037|162|I|Keep a list of all the products you use (including||
0037|163|I|prescription/nonprescription drugs and herbal products) and share||
0037|164|I|it with your doctor and pharmacist. Do not start, stop, or change||
0037|165|I|the dosage of any medicines without your doctor's approval.||
0037|166|I|   A product that may interact with this drug is: repaglinide.||
0037|167|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0037|168|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0037|169|I|heartbeat you would usually feel when your blood sugar falls too||
0037|170|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0037|171|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0037|172|I|   Many drugs can affect your blood sugar levels, making it more||
0037|173|I|difficult to control your blood sugar. Before you start, stop, or||
0037|174|I|change any medication, talk with your doctor or pharmacist about||
0037|175|I|how the medication may affect your blood sugar. Check your blood||
0037|176|I|sugar regularly as directed by your doctor. Tell your doctor||
0037|177|I|about the results and of any symptoms of high or low blood sugar.||
0037|178|I|(See also Side Effects section.) Your doctor may need to adjust||
0037|179|I|your diabetes medication, exercise program, or diet.||
0037|180|B|||
0037|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0037|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0037|183|O|poison control center right away. US residents can call||
0037|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0037|185|O|Symptoms of overdose may include: signs of low blood sugar such||
0037|186|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
0037|187|B|||
0037|188|N|NOTES:  Do not share this medication, needles, or syringes with||
0037|189|N|others.||
0037|190|N|   Attend a diabetes education program to learn more about how to||
0037|191|N|manage your diabetes with medications, diet, exercise, and||
0037|192|N|regular medical exams.||
0037|193|N|   Learn the symptoms of high and low blood sugar and how to||
0037|194|N|treat low blood sugar. Check your blood sugar regularly as||
0037|195|N|directed and share the results with your doctor.||
0037|196|N|   Lab and/or medical tests (such as liver/kidney function,||
0037|197|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
0037|198|N|should be done while you are taking this medication. Keep all||
0037|199|N|medical and lab appointments.||
0037|200|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
0037|201|B|||
0037|202|D|MISSED DOSE:  It is very important to follow your insulin regimen||
0037|203|D|exactly. Ask your doctor ahead of time what you should do if you||
0037|204|D|miss a dose of insulin.||
0037|205|B|||
0037|206|R|STORAGE:  Different brands of this medication have different||
0037|207|R|storage needs. Check the product package for instructions on how||
0037|208|R|to store your brand, or ask your pharmacist. Protect insulin from||
0037|209|R|light and heat. Do not store in the bathroom. Do not freeze, and||
0037|210|R|do not use insulin that has been frozen. Throw away all insulin||
0037|211|R|products after the expiration date on the package, or after the||
0037|212|R|specified number of days after it has been opened or kept at room||
0037|213|R|temperature, whichever date is earlier. Keep all medications away||
0037|214|R|from children and pets.||
0037|215|R|   Do not flush medications down the toilet or pour them into a||
0037|216|R|drain unless instructed to do so. Properly discard this product||
0037|217|R|when it is expired or no longer needed. Consult your pharmacist||
0037|218|R|or local waste disposal company.||
0037|219|B|||
0037|220|M|MEDICAL ALERT:  Your condition can cause complications in a||
0037|221|M|medical emergency. For information about enrolling in MedicAlert,||
0037|222|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0037|223|B|||
0037|224|A|Information last revised April 2025.||
0037|225|A|Copyright(c) 2025 First Databank, Inc.||
0037|226|B|||
0038|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0038|002|Z|does NOT have all possible information about this product. This||
0038|003|Z|information does not assure that this product is safe, effective,||
0038|004|Z|or appropriate for you. This information is not individual||
0038|005|Z|medical advice and does not substitute for the advice of your||
0038|006|Z|health care professional. Always ask your health care||
0038|007|Z|professional for complete information about this product and your||
0038|008|Z|specific health needs.||
0038|009|B|||
0038|010|T|IRON SUPPLEMENTS - ORAL||
0038|011|B|||
0038|012|W|WARNING:  Accidental overdose of iron-containing products is a||
0038|013|W|leading cause of fatal poisoning in children younger than 6||
0038|014|W|years. Keep this product out of reach of children. If overdose||
0038|015|W|does occur, get medical help right away or call a poison control||
0038|016|W|center.||
0038|017|B|||
0038|018|U|USES:  This medication is an iron supplement used to treat or||
0038|019|U|prevent low blood levels of iron (such as those caused by anemia||
0038|020|U|or pregnancy). Iron is an important mineral that the body needs||
0038|021|U|to produce red blood cells and keep you in good health.||
0038|022|B|||
0038|023|H|HOW TO USE:  Follow all directions on the product package, or||
0038|024|H|take as directed by your doctor. Do not take more than the||
0038|025|H|recommended dosage. If you have any questions, ask your doctor or||
0038|026|H|pharmacist.||
0038|027|H|   Iron is best absorbed on an empty stomach (usually if taken 1||
0038|028|H|hour before or 2 hours after meals). If stomach upset occurs, you||
0038|029|H|may take this medication with food. See the instructions below||
0038|030|H|for the liquid drops for infants/children. Avoid taking antacids,||
0038|031|H|dairy products, tea, or coffee within 2 hours before or after||
0038|032|H|this medication because they will decrease its effectiveness.||
0038|033|H|   Take tablets or capsules with a full glass of water (8 ounces||
0038|034|H|or 240 milliliters) unless otherwise directed by your doctor. Do||
0038|035|H|not lie down for at least 10 minutes after taking your tablet or||
0038|036|H|capsule dose.||
0038|037|H|   Swallow extended-release capsules whole. Do not crush or chew||
0038|038|H|extended-release capsules or tablets. Doing so can release all of||
0038|039|H|the drug at once, increasing the risk of side effects. Also, do||
0038|040|H|not split extended-release tablets unless they have a score line||
0038|041|H|and your doctor or pharmacist tells you to do so. Swallow the||
0038|042|H|whole or split tablet without crushing or chewing.||
0038|043|H|   If you are taking chewable tablets, chew the medication||
0038|044|H|thoroughly, then swallow.||
0038|045|H|   If you are taking a liquid suspension form of this medication,||
0038|046|H|shake the bottle well before each dose.||
0038|047|H|   If you are taking the liquid form for adults, carefully||
0038|048|H|measure the dose using a special measuring device/spoon. Do not||
0038|049|H|use a household spoon because you may not get the correct dose.||
0038|050|H|Mix the dose in a glass of water or juice, and drink the mixture||
0038|051|H|through a straw to prevent staining the teeth.||
0038|052|H|   If you are giving the liquid drops to an infant or child, use||
0038|053|H|the dropper provided to carefully measure the dose. The dose may||
0038|054|H|be placed directly into the mouth (towards the back of the||
0038|055|H|tongue) or it may be mixed in formula (not milk), fruit juice,||
0038|056|H|cereal, or other food as directed to increase your child's||
0038|057|H|acceptance. It is best to give this medication right after a||
0038|058|H|meal. Follow the directions on the product package for the brand||
0038|059|H|that you use.||
0038|060|H|   Take this medication regularly in order to get the most||
0038|061|H|benefit from it. To help you remember, take it at the same||
0038|062|H|time(s) each day.||
0038|063|B|||
0038|064|S|SIDE EFFECTS:  Constipation, diarrhea, stomach cramps, or upset||
0038|065|S|stomach may occur. These effects are usually temporary and may||
0038|066|S|disappear as your body adjusts to this medication. If any of||
0038|067|S|these effects last or get worse, contact your doctor or||
0038|068|S|pharmacist promptly.||
0038|069|S|   Iron may cause your stools to turn black, an effect that is||
0038|070|S|not harmful.||
0038|071|S|   If your doctor has prescribed this medication, remember that||
0038|072|S|your doctor has judged that the benefit to you is greater than||
0038|073|S|the risk of side effects. Many people using this medication do||
0038|074|S|not have serious side effects.||
0038|075|S|   A very serious allergic reaction to this drug is rare.||
0038|076|S|However, get medical help right away if you notice any symptoms||
0038|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0038|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0038|079|S|breathing.||
0038|080|S|   This is not a complete list of possible side effects. If you||
0038|081|S|notice other effects not listed above, contact your doctor or||
0038|082|S|pharmacist.||
0038|083|S|   In the US -||
0038|084|S|   Call your doctor for medical advice about side effects. You||
0038|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0038|086|S|www.fda.gov/medwatch.||
0038|087|S|   In Canada - Call your doctor for medical advice about side||
0038|088|S|effects. You may report side effects to Health Canada at||
0038|089|S|1-866-234-2345.||
0038|090|B|||
0038|091|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0038|092|P|pharmacist if you are allergic to it; or if you have any other||
0038|093|P|allergies. This product may contain inactive ingredients, which||
0038|094|P|can cause allergic reactions or other problems. Talk to your||
0038|095|P|pharmacist for more details.||
0038|096|P|   Before taking this medication, tell your doctor or pharmacist||
0038|097|P|your medical history, especially of: iron overload disorder (such||
0038|098|P|as hemochromatosis, hemosiderosis), use/abuse of alcohol, liver||
0038|099|P|problems, stomach/intestinal problems (such as ulcer, colitis).||
0038|100|P|   If your brand of iron supplement also contains folic acid, be||
0038|101|P|sure to tell your doctor or pharmacist if you have vitamin B12||
0038|102|P|deficiency (pernicious anemia) before taking it. Folic acid may||
0038|103|P|falsely improve certain lab tests for vitamin B12 deficiency||
0038|104|P|without actually treating this anemia. Untreated vitamin B12||
0038|105|P|deficiency may result in serious nerve problems (for example,||
0038|106|P|peripheral neuropathy symptoms such as numbness/pain/tingling||
0038|107|P|sensations). Consult your doctor or pharmacist for details.||
0038|108|P|   Chewable tablets of this medicine may contain aspartame. If||
0038|109|P|you have phenylketonuria (PKU) or any other condition that||
0038|110|P|requires you to restrict your intake of aspartame (or||
0038|111|P|phenylalanine), consult your doctor or pharmacist about using||
0038|112|P|this drug safely.||
0038|113|P|   Liquid preparations of this product may contain sugar and/or||
0038|114|P|alcohol. Caution is advised if you have diabetes, alcohol||
0038|115|P|dependence, or liver disease. Ask your doctor or pharmacist about||
0038|116|P|using this product safely.||
0038|117|P|   During pregnancy, this medication should be used only when||
0038|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
0038|119|P|   This medication passes into breast milk. Consult your doctor||
0038|120|P|before breastfeeding.||
0038|121|B|||
0038|122|I|DRUG INTERACTIONS:  See also How to Use section.||
0038|123|I|   Drug interactions may change how your medications work or||
0038|124|I|increase your risk for serious side effects. This document does||
0038|125|I|not contain all possible drug interactions. Keep a list of all||
0038|126|I|the products you use (including prescription/nonprescription||
0038|127|I|drugs and herbal products) and share it with your doctor and||
0038|128|I|pharmacist. Do not start, stop, or change the dosage of any||
0038|129|I|medicines without your doctor's approval.||
0038|130|I|   This product can decrease the absorption of certain drugs,||
0038|131|I|especially if you take them around the same time. These drugs||
0038|132|I|include bisphosphonates (such as alendronate), levodopa,||
0038|133|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
0038|134|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
0038|135|I|minocycline), thyroid medications (such as levothyroxine), among||
0038|136|I|others. Ask your doctor or pharmacist how long you should wait||
0038|137|I|between doses of this product and your other medications and to||
0038|138|I|find a dosing schedule that works for all your medications.||
0038|139|I|   This medication may interfere with certain lab tests (such as||
0038|140|I|fecal occult blood tests), possibly causing false test results.||
0038|141|I|Make sure lab personnel and all your doctors know you use this||
0038|142|I|drug.||
0038|143|B|||
0038|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0038|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0038|146|O|poison control center right away. US residents can call||
0038|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0038|148|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
0038|149|O|diarrhea.||
0038|150|B|||
0038|151|N|NOTES:  If your doctor has prescribed this medication, do not||
0038|152|N|share it with others.||
0038|153|N|   Lab and/or medical tests (such as complete blood count) may be||
0038|154|N|done while you are taking this product. Keep all medical and lab||
0038|155|N|appointments. Consult your doctor for more details.||
0038|156|N|   This medication is not a substitute for a proper diet. It is||
0038|157|N|important to maintain a well-balanced diet. Foods rich in iron||
0038|158|N|include red meats (especially liver), fish, beans, dried fruit,||
0038|159|N|and iron-fortified/enriched cereals and bread.||
0038|160|B|||
0038|161|D|MISSED DOSE:  If you are taking this product on a prescribed||
0038|162|D|schedule and miss a dose, take it as soon as you remember. If it||
0038|163|D|is near the time for the next dose, skip the missed dose. Take||
0038|164|D|your next dose at the regular time. Do not double the dose to||
0038|165|D|catch up.||
0038|166|B|||
0038|167|R|STORAGE:  Store at room temperature away from light and moisture.||
0038|168|R|Do not freeze liquid forms of this medication. Do not store in||
0038|169|R|the bathroom. Keep all medications away from children and pets.||
0038|170|R|   Do not flush medications down the toilet or pour them into a||
0038|171|R|drain unless instructed to do so. Properly discard this product||
0038|172|R|when it is expired or no longer needed. Consult your pharmacist||
0038|173|R|or local waste disposal company.||
0038|174|B|||
0038|175|A|Information last revised October 2025.||
0038|176|A|Copyright(c) 2025 First Databank, Inc.||
0038|177|B|||
0039|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0039|002|Z|does NOT have all possible information about this product. This||
0039|003|Z|information does not assure that this product is safe, effective,||
0039|004|Z|or appropriate for you. This information is not individual||
0039|005|Z|medical advice and does not substitute for the advice of your||
0039|006|Z|health care professional. Always ask your health care||
0039|007|Z|professional for complete information about this product and your||
0039|008|Z|specific health needs.||
0039|009|B|||
0039|010|T|ISOTRETINOIN - ORAL||
0039|011|F|(EYE-soe-TRET-i-noyn)||
0039|012|B|||
0039|013|C|COMMON BRAND NAME(S): Absorica, Absorica LD, Accutane, Amnesteem,||
0039|014|C|Claravis, Sotret||
0039|015|B|||
0039|016|W|WARNING:  Women who are pregnant must not use isotretinoin. Women||
0039|017|W|must avoid becoming pregnant while taking this medication.||
0039|018|W|Serious (sometimes fatal) birth defects, miscarriages, and||
0039|019|W|premature births have occurred when this drug has been used||
0039|020|W|during pregnancy.||
0039|021|W|   For female patients, two effective forms of birth control (or||
0039|022|W|complete avoidance of sexual intercourse) must be used for 1||
0039|023|W|month before starting isotretinoin, during use, and for 1 month||
0039|024|W|after stopping this drug. You must also have monthly||
0039|025|W|pregnancy-avoidance counseling from your doctor. Do not use||
0039|026|W|"minipills" for birth control (non-estrogen-containing pills)||
0039|027|W|since they may not work as well with isotretinoin. If you are||
0039|028|W|late in having your period, or if you have sexual intercourse at||
0039|029|W|any time without using two effective forms of birth control, stop||
0039|030|W|taking this medication and contact your doctor right away. (See||
0039|031|W|also the Precautions section.)||
0039|032|W|   To receive isotretinoin in the United States, you must||
0039|033|W|understand, agree to, and carefully follow the requirements of||
0039|034|W|the REMS Program for this medication. If you live in Canada or||
0039|035|W|any other country, consult your doctor and pharmacist for your||
0039|036|W|country's regulations.||
0039|037|W|   Talk with your doctor about the risks and benefits of using||
0039|038|W|this medication.||
0039|039|B|||
0039|040|U|USES:  This medication is used to treat severe cystic acne (also||
0039|041|U|known as nodular acne) that has not responded to other treatment||
0039|042|U|(such as benzoyl peroxide or clindamycin applied to the skin or||
0039|043|U|tetracycline or minocycline taken by mouth). It belongs to a||
0039|044|U|class of drugs known as retinoids. It works by decreasing facial||
0039|045|U|oil (sebum) production. High amounts of sebum can lead to severe||
0039|046|U|acne. If left untreated, severe acne may cause permanent||
0039|047|U|scarring.||
0039|048|B|||
0039|049|V|OTHER USES:  This section contains uses of this drug that are not||
0039|050|V|listed in the approved professional labeling for the drug but||
0039|051|V|that may be prescribed by your health care professional. Use this||
0039|052|V|drug for a condition that is listed in this section only if it||
0039|053|V|has been so prescribed by your health care professional.||
0039|054|V|   This drug may also be used for a certain type of cancer||
0039|055|V|(neuroblastoma).||
0039|056|B|||
0039|057|H|HOW TO USE:  Read the Medication Guide provided by your||
0039|058|H|pharmacist before you start using isotretinoin and each time you||
0039|059|H|get a refill. Read and sign a Patient Information/Informed||
0039|060|H|Consent form before you start taking this medication. If you have||
0039|061|H|any questions about isotretinoin, consult your doctor or||
0039|062|H|pharmacist before taking the medication.||
0039|063|H|   Take this medication by mouth as directed by your doctor,||
0039|064|H|usually twice daily for 15 to 20 weeks. Swallow the capsules||
0039|065|H|whole. Do not crush or chew them. Some brands of this drug say to||
0039|066|H|take this medication with meals while other brands say that it||
0039|067|H|may be taken with or without food. Food helps increase absorption||
0039|068|H|of this drug into your bloodstream. Ask your doctor or pharmacist||
0039|069|H|for more information.||
0039|070|H|   Take this medication with a full glass of water (8 ounces/240||
0039|071|H|milliliters) unless your doctor directs you otherwise. Do not lie||
0039|072|H|down for at least 10 minutes after taking this medication.||
0039|073|H|   The dosage is based on your medical condition, weight, and||
0039|074|H|response to treatment.||
0039|075|H|   Your acne may worsen during the first few days of taking this||
0039|076|H|drug, and it may take up to 1-2 months before you notice the full||
0039|077|H|benefit of this medication. If severe acne returns, a second||
0039|078|H|course of treatment may be started after you have stopped taking||
0039|079|H|the drug for 2 months. The manufacturer does not recommend||
0039|080|H|long-term use of isotretinoin. Do not take more than the||
0039|081|H|recommended dose.||
0039|082|H|   Since this drug can be absorbed through the skin and lungs and||
0039|083|H|may harm an unborn baby, women who are pregnant or who may become||
0039|084|H|pregnant should not handle this medication or breathe the dust||
0039|085|H|from the capsules.||
0039|086|B|||
0039|087|S|SIDE EFFECTS:  Dry lips and mouth, minor swelling of the eyelids||
0039|088|S|or lips, crusty skin, nosebleeds, upset stomach, or thinning of||
0039|089|S|hair may occur. If any of these effects last or get worse, tell||
0039|090|S|your doctor or pharmacist promptly.||
0039|091|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0039|092|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0039|093|S|substitute.||
0039|094|S|   Remember that this medication has been prescribed because your||
0039|095|S|doctor has judged that the benefit to you is greater than the||
0039|096|S|risk of side effects. Many people using this medication do not||
0039|097|S|have serious side effects.||
0039|098|S|   Tell your doctor right away if you have any serious side||
0039|099|S|effects, including: mental/mood changes (such as depression,||
0039|100|S|anxiety, thoughts of suicide), tingling feeling in the skin,||
0039|101|S|back/joint/muscle pain, signs of infection (such as sore throat||
0039|102|S|that doesn't go away, fever, chills), painful swallowing, peeling||
0039|103|S|skin on palms/soles.||
0039|104|S|   Isotretinoin may rarely cause disease of the pancreas||
0039|105|S|(pancreatitis) that may rarely be fatal. Stop taking this||
0039|106|S|medication and tell your doctor right away if you develop: severe||
0039|107|S|stomach pain, nausea/vomiting that is severe or doesn't stop.||
0039|108|S|   Stop taking this medication and tell your doctor right away if||
0039|109|S|you have any very serious side effects, including: severe||
0039|110|S|headache, vision changes, ringing in the ears, hearing loss,||
0039|111|S|chest pain, yellowing eyes/skin, dark urine, severe diarrhea,||
0039|112|S|rectal bleeding.||
0039|113|S|   A very serious allergic reaction to this drug is rare.||
0039|114|S|However, get medical help right away if you notice any symptoms||
0039|115|S|of a serious allergic reaction, including: rash, itching/swelling||
0039|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0039|117|S|breathing.||
0039|118|S|   This is not a complete list of possible side effects. If you||
0039|119|S|notice other effects not listed above, contact your doctor or||
0039|120|S|pharmacist.||
0039|121|S|   In the US -||
0039|122|S|   Call your doctor for medical advice about side effects. You||
0039|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0039|124|S|www.fda.gov/medwatch.||
0039|125|S|   In Canada - Call your doctor for medical advice about side||
0039|126|S|effects. You may report side effects to Health Canada at||
0039|127|S|1-866-234-2345.||
0039|128|B|||
0039|129|P|PRECAUTIONS:  Before taking isotretinoin, tell your doctor or||
0039|130|P|pharmacist if you are allergic to it; or to vitamin A-related||
0039|131|P|drugs (other retinoids such as tretinoin); or if you have any||
0039|132|P|other allergies. This product may contain inactive ingredients||
0039|133|P|(such as soybean, parabens), which can cause allergic reactions||
0039|134|P|or other problems. Some people who are allergic to peanuts may||
0039|135|P|also be allergic to soy. Talk to your pharmacist for more||
0039|136|P|details.||
0039|137|P|   Before using this medication, tell your doctor or pharmacist||
0039|138|P|your medical history, especially of: diabetes, family or personal||
0039|139|P|history of high blood fats (triglycerides), mental/mood problems||
0039|140|P|(such as depression), liver disease, obesity, eating disorders||
0039|141|P|(such as anorexia nervosa), alcohol abuse, pancreatitis, bone||
0039|142|P|loss conditions (such as osteoporosis/osteomalacia, decreased||
0039|143|P|bone density).||
0039|144|P|   Do not donate blood while you are taking isotretinoin and for||
0039|145|P|at least 1 month after you stop taking it.||
0039|146|P|   This medication may make you more sensitive to the sun. Limit||
0039|147|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0039|148|P|sunscreen and wear protective clothing when outdoors. Tell your||
0039|149|P|doctor right away if you get sunburned or have skin||
0039|150|P|blisters/redness.||
0039|151|P|   Isotretinoin can affect your night vision. Do not drive, use||
0039|152|P|machinery, or do anything that needs clear vision (especially at||
0039|153|P|night) until you can do it safely.||
0039|154|P|   If you wear contact lenses, you may not tolerate them as well||
0039|155|P|as usual while using this medication. Contact your doctor for||
0039|156|P|more information.||
0039|157|P|   Do not have cosmetic procedures to smooth your skin (such as||
0039|158|P|waxing, laser, dermabrasion) during and for 6 months after||
0039|159|P|isotretinoin therapy. Skin scarring may occur.||
0039|160|P|   Avoid the use of alcohol while taking this medication because||
0039|161|P|it may increase the risk of certain side effects (such as||
0039|162|P|pancreatitis).||
0039|163|P|   Limited information suggests isotretinoin may cause some bone||
0039|164|P|loss effects. Playing contact or repetitive impact sports (such||
0039|165|P|as football, basketball, soccer, tennis) may result in bone||
0039|166|P|problems, including an increased risk of broken bones. Limited||
0039|167|P|information also suggests isotretinoin may stop normal growth in||
0039|168|P|some children (epiphyseal plate closure). Consult your doctor for||
0039|169|P|more details.||
0039|170|P|   Older adults may be more sensitive to the side effects of this||
0039|171|P|drug, especially the effects on bones.||
0039|172|P|   Children may be more sensitive to the side effects of this||
0039|173|P|drug, especially back/joint/muscle pain.||
0039|174|P|   This drug must not be used during pregnancy or by those who||
0039|175|P|may become pregnant during treatment. If you become pregnant or||
0039|176|P|think you may be pregnant, inform your doctor right away. See||
0039|177|P|also Warning section.||
0039|178|P|   Since this drug can be absorbed through the skin and lungs and||
0039|179|P|may harm an unborn baby, women who are pregnant or who may become||
0039|180|P|pregnant should not handle this medication or breathe the dust||
0039|181|P|from the capsules.||
0039|182|P|   You must have two negative pregnancy tests before starting||
0039|183|P|this medication. You must have a monthly pregnancy test during||
0039|184|P|treatment with isotretinoin. If the test is positive, you must||
0039|185|P|stop taking this medication and consult your doctor right away.||
0039|186|P|   It is unknown if this medication passes into breast milk.||
0039|187|P|However, similar drugs pass into breast milk. Breastfeeding is||
0039|188|P|not recommended while using this medication. Ask your doctor when||
0039|189|P|you can breastfeed after stopping treatment. Consult your doctor||
0039|190|P|before breastfeeding.||
0039|191|B|||
0039|192|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0039|193|I|medications work or increase your risk for serious side effects.||
0039|194|I|This document does not contain all possible drug interactions.||
0039|195|I|Keep a list of all the products you use (including||
0039|196|I|prescription/nonprescription drugs and herbal products) and share||
0039|197|I|it with your doctor and pharmacist. Do not start, stop, or change||
0039|198|I|the dosage of any medicines without your doctor's approval.||
0039|199|I|   Some products that may interact with this drug are:||
0039|200|I|tetracyclines (such as minocycline, tetracycline), vitamin A-type||
0039|201|I|drugs (such as acitretin, bexarotene), vitamin A, drugs that||
0039|202|I|cause bone loss (for example, anti-seizure drugs such as||
0039|203|I|phenytoin, corticosteroids such as prednisone).||
0039|204|I|   Tell your doctor when you start any new drug, and discuss if||
0039|205|I|you should use reliable backup birth control. Also tell your||
0039|206|I|doctor if you have any new spotting or breakthrough bleeding,||
0039|207|I|because these may be signs that your birth control is not working||
0039|208|I|well. (See also Warning section.)||
0039|209|B|||
0039|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0039|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0039|212|O|poison control center right away. US residents can call||
0039|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0039|214|O|Symptoms of overdose may include: vomiting, stomach pain, facial||
0039|215|O|flushing, headache, loss of balance.||
0039|216|B|||
0039|217|N|NOTES:  Do not allow anyone else to take this medication. It can||
0039|218|N|cause birth defects and other serious health problems.||
0039|219|N|   Lab and/or medical tests (such as pregnancy test, blood||
0039|220|N|cholesterol/triglyceride levels, liver function, white blood||
0039|221|N|count, eye exams) should be done while you are taking this||
0039|222|N|medication. Keep all medical and lab appointments. Consult your||
0039|223|N|doctor for more details.||
0039|224|B|||
0039|225|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
0039|226|D|next dose at the regular time. Do not double the dose to catch||
0039|227|D|up.||
0039|228|B|||
0039|229|R|STORAGE:  Store at room temperature away from light and moisture.||
0039|230|R|Do not store in the bathroom. Keep all medications out of reach||
0039|231|R|of children and pets.||
0039|232|R|   Do not flush medications down the toilet or pour them into a||
0039|233|R|drain unless instructed to do so. Properly discard this product||
0039|234|R|when it is expired or no longer needed. Consult your pharmacist||
0039|235|R|or local waste disposal company.||
0039|236|B|||
0039|237|A|Information last revised April 2025.||
0039|238|A|Copyright(c) 2025 First Databank, Inc.||
0039|239|B|||
0040|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0040|002|Z|does NOT have all possible information about this product. This||
0040|003|Z|information does not assure that this product is safe, effective,||
0040|004|Z|or appropriate for you. This information is not individual||
0040|005|Z|medical advice and does not substitute for the advice of your||
0040|006|Z|health care professional. Always ask your health care||
0040|007|Z|professional for complete information about this product and your||
0040|008|Z|specific health needs.||
0040|009|B|||
0040|010|T|ISONIAZID - ORAL||
0040|011|F|(EYE-soe-NYE-a-zid)||
0040|012|B|||
0040|013|C|COMMON BRAND NAME(S): Niazid||
0040|014|B|||
0040|015|W|WARNING:  Isoniazid has rarely caused very serious (possibly||
0040|016|W|fatal) liver disease. The risk of liver disease is increased in||
0040|017|W|people who are 35 years and older, who use alcohol or illegal||
0040|018|W|injection drugs, or who currently have long-term liver problems.||
0040|019|W|Tell your doctor right away if you develop symptoms of liver||
0040|020|W|disease, including nausea/vomiting that doesn't stop, severe||
0040|021|W|stomach/abdominal pain, unusual weakness/tiredness, dark urine,||
0040|022|W|yellowing eyes/skin.||
0040|023|W|   Your doctor should order liver function tests while you are||
0040|024|W|taking this medication. Keep all medical and lab appointments.||
0040|025|B|||
0040|026|U|USES:  Isoniazid is used with other medications to treat active||
0040|027|U|tuberculosis (TB) infections. It is also used alone to prevent||
0040|028|U|active TB infections in people who may be infected with the||
0040|029|U|bacteria (people with positive TB skin test). Isoniazid is an||
0040|030|U|antibiotic and works by stopping the growth of bacteria.||
0040|031|U|   This antibiotic treats only bacterial infections. It will not||
0040|032|U|work for viral infections (such as common cold, flu). Using any||
0040|033|U|antibiotic when it is not needed can cause it to not work for||
0040|034|U|future infections.||
0040|035|B|||
0040|036|H|HOW TO USE:  Take this medication by mouth on an empty stomach (1||
0040|037|H|hour before or 2 hours after meals) as directed by your doctor.||
0040|038|H|If you are using the liquid form of this medication, carefully||
0040|039|H|measure the dose using a special measuring device/spoon. Do not||
0040|040|H|use a household spoon because you may not get the correct dose.||
0040|041|H|   If you also take antacids that contain aluminum, take this||
0040|042|H|medication at least 1 hour before the antacid.||
0040|043|H|   The dosage is based on your age, weight, medical condition,||
0040|044|H|and response to treatment.||
0040|045|H|   For the best effect, take this drug at evenly spaced times. If||
0040|046|H|you are taking this medication daily, take it at the same time||
0040|047|H|each day. If you are taking this medication on a weekly schedule,||
0040|048|H|take it on the same day(s) and time each week. To help you||
0040|049|H|remember, mark your calendar with a reminder.||
0040|050|H|   Continue to take this medication (and other TB medications)||
0040|051|H|until the full prescribed amount is finished, even if symptoms||
0040|052|H|disappear. Stopping the medication too early or skipping doses||
0040|053|H|may result in a return of the infection and cause the infection||
0040|054|H|to be more difficult to treat (resistant).||
0040|055|H|   Your doctor may also direct you to take vitamin B6||
0040|056|H|(pyridoxine) to help prevent certain side effects (such as nerve||
0040|057|H|problems) from isoniazid. Follow your doctor's instructions||
0040|058|H|carefully.||
0040|059|H|   Isoniazid may interact with foods containing||
0040|060|H|tyramine/histamine (such as cheese, red wine, certain types of||
0040|061|H|fish). This interaction may cause increased blood pressure,||
0040|062|H|flushing of the skin, headache, dizziness, or fast/pounding||
0040|063|H|heartbeat. Tell your doctor right away if any of these symptoms||
0040|064|H|occur. Your doctor may recommend that you follow a special diet||
0040|065|H|while taking this medication. Consult your doctor for more||
0040|066|H|details.||
0040|067|H|   Tell your doctor if your condition lasts or gets worse.||
0040|068|B|||
0040|069|S|SIDE EFFECTS:  See also Warning section.||
0040|070|S|   Nausea/vomiting or stomach upset may occur. If any of these||
0040|071|S|effects last or get worse, tell your doctor or pharmacist||
0040|072|S|promptly.||
0040|073|S|   Remember that this medication has been prescribed because your||
0040|074|S|doctor has judged that the benefit to you is greater than the||
0040|075|S|risk of side effects. Many people using this medication do not||
0040|076|S|have serious side effects.||
0040|077|S|   Tell your doctor right away if you have any serious side||
0040|078|S|effects, including: numbness/tingling of arms/legs, loss of||
0040|079|S|coordination, painful/swollen joints, increased thirst/urination,||
0040|080|S|vision changes, easy bruising/bleeding, mental/mood changes (such||
0040|081|S|as confusion, psychosis), trouble speaking, seizures.||
0040|082|S|   A very serious allergic reaction to this drug is rare.||
0040|083|S|However, get medical help right away if you notice any symptoms||
0040|084|S|of a serious allergic reaction, including: fever that doesn't go||
0040|085|S|away, new or worsening lymph node swelling, rash,||
0040|086|S|itching/swelling (especially of the face/tongue/throat), severe||
0040|087|S|dizziness, trouble breathing.||
0040|088|S|   This is not a complete list of possible side effects. If you||
0040|089|S|notice other effects not listed above, contact your doctor or||
0040|090|S|pharmacist.||
0040|091|S|   In the US -||
0040|092|S|   Call your doctor for medical advice about side effects. You||
0040|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0040|094|S|www.fda.gov/medwatch.||
0040|095|S|   In Canada - Call your doctor for medical advice about side||
0040|096|S|effects. You may report side effects to Health Canada at||
0040|097|S|1-866-234-2345.||
0040|098|B|||
0040|099|P|PRECAUTIONS:  See also Warning section.||
0040|100|P|   Before taking isoniazid, tell your doctor or pharmacist if you||
0040|101|P|are allergic to it; or if you have any other allergies. This||
0040|102|P|product may contain inactive ingredients, which can cause||
0040|103|P|allergic reactions or other problems. Talk to your pharmacist for||
0040|104|P|more details.||
0040|105|P|   Before using this medication, tell your doctor or pharmacist||
0040|106|P|your medical history, especially of: previous severe reaction||
0040|107|P|from isoniazid (such as liver disease), liver disease, alcohol||
0040|108|P|use, HIV infection, kidney disease, diabetes, numbness/tingling||
0040|109|P|of arms/legs (peripheral neuropathy), recent childbirth.||
0040|110|P|   Before having surgery, tell your doctor or dentist about all||
0040|111|P|the products you use (including prescription drugs,||
0040|112|P|nonprescription drugs, and herbal products).||
0040|113|P|   Alcohol may increase the risk of liver disease. Avoid||
0040|114|P|alcoholic beverages while using this medication.||
0040|115|P|   This product may cause live bacterial vaccines (such as BCG||
0040|116|P|vaccine) to not work well. Tell your health care professional||
0040|117|P|that you are using this medication before having any||
0040|118|P|immunizations/vaccinations.||
0040|119|P|   Liquid forms of this medication may contain sugar. Caution is||
0040|120|P|advised if you have diabetes or any other condition that requires||
0040|121|P|you to limit/avoid sugar. Ask your doctor or pharmacist about||
0040|122|P|using this product safely.||
0040|123|P|   During pregnancy, this medication should be used only when||
0040|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
0040|125|P|   This product passes into breast milk but is unlikely to harm a||
0040|126|P|nursing infant. Consult your doctor before breastfeeding.||
0040|127|B|||
0040|128|I|DRUG INTERACTIONS:  See also How to Use section.||
0040|129|I|   Drug interactions may change how your medications work or||
0040|130|I|increase your risk for serious side effects. This document does||
0040|131|I|not contain all possible drug interactions. Keep a list of all||
0040|132|I|the products you use (including prescription/nonprescription||
0040|133|I|drugs and herbal products) and share it with your doctor and||
0040|134|I|pharmacist. Do not start, stop, or change the dosage of any||
0040|135|I|medicines without your doctor's approval.||
0040|136|I|   Some products that may interact with this drug include:||
0040|137|I|acetaminophen, certain azole antifungals (itraconazole,||
0040|138|I|ketoconazole), disulfiram, MAO inhibitors (isocarboxazid,||
0040|139|I|linezolid, metaxalone, methylene blue, moclobemide, phenelzine,||
0040|140|I|procarbazine, rasagiline, safinamide, selegiline,||
0040|141|I|tranylcypromine), phenytoin, SSRI antidepressants (such as||
0040|142|I|fluoxetine, sertraline), valproic acid.||
0040|143|I|   This medication may interfere with certain lab tests (such as||
0040|144|I|urine glucose tests), possibly causing false test results. Make||
0040|145|I|sure lab personnel and all your doctors know you use this drug.||
0040|146|B|||
0040|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0040|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0040|149|O|poison control center right away. US residents can call||
0040|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0040|151|O|Symptoms of overdose may include: vision changes, slow/shallow||
0040|152|O|breathing, severe drowsiness.||
0040|153|B|||
0040|154|N|NOTES:  Do not share this medication with others.||
0040|155|N|   Lab and/or medical tests (such as sputum test, kidney/liver||
0040|156|N|function, complete blood count) should be done while you are||
0040|157|N|taking this medication. Keep all medical and lab appointments.||
0040|158|N|Consult your doctor for more details.||
0040|159|B|||
0040|160|D|MISSED DOSE:  It is important to take each dose of this||
0040|161|D|medication as scheduled. If you are taking this medication daily||
0040|162|D|and miss a dose, take it as soon as you remember. If it is near||
0040|163|D|the time of the next dose, skip the missed dose. Take your next||
0040|164|D|dose at the regular time. Do not double the dose to catch up.||
0040|165|D|   If you are taking this drug on a weekly schedule and miss a||
0040|166|D|dose, take it as soon as you remember. If you don't remember||
0040|167|D|until the next day or later, ask your doctor or pharmacist right||
0040|168|D|away for a new dosing schedule. Do not double the dose to catch||
0040|169|D|up.||
0040|170|B|||
0040|171|R|STORAGE:  Store at room temperature away from light and moisture.||
0040|172|R|Do not store in the bathroom. Keep all medications away from||
0040|173|R|children and pets.||
0040|174|R|   Do not flush medications down the toilet or pour them into a||
0040|175|R|drain unless instructed to do so. Properly discard this product||
0040|176|R|when it is expired or no longer needed. Consult your pharmacist||
0040|177|R|or local waste disposal company.||
0040|178|B|||
0040|179|A|Information last revised February 2025.||
0040|180|A|Copyright(c) 2025 First Databank, Inc.||
0040|181|B|||
0041|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0041|002|Z|does NOT have all possible information about this product. This||
0041|003|Z|information does not assure that this product is safe, effective,||
0041|004|Z|or appropriate for you. This information is not individual||
0041|005|Z|medical advice and does not substitute for the advice of your||
0041|006|Z|health care professional. Always ask your health care||
0041|007|Z|professional for complete information about this product and your||
0041|008|Z|specific health needs.||
0041|009|B|||
0041|010|T|CARBIDOPA/LEVODOPA - ORAL||
0041|011|F|(KAR-bi-DOE-pa/LEE-voe-DOE-pa)||
0041|012|B|||
0041|013|C|COMMON BRAND NAME(S): Sinemet||
0041|014|B|||
0041|015|U|USES:  This combination medication is used to treat symptoms of||
0041|016|U|Parkinson's disease or Parkinson-like symptoms (such as||
0041|017|U|shakiness, stiffness, difficulty moving). Parkinson's disease is||
0041|018|U|thought to be caused by too little of a naturally occurring||
0041|019|U|substance (dopamine) in the brain. Levodopa changes into dopamine||
0041|020|U|in the brain, helping to control movement. Carbidopa prevents the||
0041|021|U|breakdown of levodopa in the bloodstream so more levodopa can||
0041|022|U|enter the brain. Carbidopa can also reduce some of levodopa's||
0041|023|U|side effects such as nausea and vomiting.||
0041|024|B|||
0041|025|H|HOW TO USE:  Read the Instructions for Use if available from your||
0041|026|H|pharmacist before you start taking carbidopa/levodopa and each||
0041|027|H|time you get a refill. If you have any questions, ask your doctor||
0041|028|H|or pharmacist.||
0041|029|H|   Take this medication by mouth with or without food as directed||
0041|030|H|by your doctor, usually 3 to 4 times a day.||
0041|031|H|   Taking this medication with food may help to decrease nausea.||
0041|032|H|It is best to avoid a high-protein diet (it decreases the amount||
0041|033|H|of levodopa that your body takes in) during treatment, unless||
0041|034|H|directed otherwise by your doctor. Separate your dose of this||
0041|035|H|medication by as many hours as possible from any iron supplements||
0041|036|H|or products containing iron (such as multivitamins with minerals)||
0041|037|H|you may take. Iron can reduce the amount of this medication||
0041|038|H|absorbed by the body. Consult your doctor or pharmacist for more||
0041|039|H|details.||
0041|040|H|   The dosage is based on your medical condition and response to||
0041|041|H|treatment. To reduce your risk of side effects, your doctor may||
0041|042|H|direct you to start this medication at a low dose and gradually||
0041|043|H|increase your dose. Follow your doctor's instructions carefully.||
0041|044|H|This combination medication comes in different strengths with||
0041|045|H|different amounts of carbidopa and levodopa in each tablet. Be||
0041|046|H|sure you have the correct strength of both drugs. Your doctor may||
0041|047|H|also prescribe carbidopa alone to be taken with this combination.||
0041|048|H|   Use this medication regularly to get the most benefit from it.||
0041|049|H|To help you remember, take it at the same times each day.||
0041|050|H|   Some patients may experience a "wearing-off" (worsening of||
0041|051|H|symptoms) before the next dose is due. An "on-off" effect might||
0041|052|H|also occur, in which sudden short periods of stiffness occur. If||
0041|053|H|these effects occur, contact your doctor for possible dose||
0041|054|H|adjustments that may help to lessen this effect.||
0041|055|H|   Do not stop taking this medication without consulting your||
0041|056|H|doctor. Some conditions may become worse when this medication is||
0041|057|H|suddenly stopped. Also, if you suddenly stop using this||
0041|058|H|medication, you may have withdrawal symptoms (such as anxiety,||
0041|059|H|depression, confusion, fever, muscle stiffness). To help prevent||
0041|060|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0041|061|H|more likely if you have used this medication for a long time or||
0041|062|H|in high doses. Tell your doctor or pharmacist right away if you||
0041|063|H|have withdrawal.||
0041|064|H|   Tell your doctor if your condition does not get better or if||
0041|065|H|it gets worse.||
0041|066|B|||
0041|067|S|SIDE EFFECTS:  Dizziness, lightheadedness, nausea, vomiting, loss||
0041|068|S|of appetite, trouble sleeping, unusual dreams, or headache may||
0041|069|S|occur. If any of these effects last or get worse, tell your||
0041|070|S|doctor or pharmacist promptly.||
0041|071|S|   This medication may cause saliva, urine, or sweat to turn a||
0041|072|S|dark color. This effect is harmless, but your clothes may be||
0041|073|S|stained.||
0041|074|S|   To reduce the risk of dizziness and lightheadedness, get up||
0041|075|S|slowly when rising from a sitting or lying position.||
0041|076|S|   Remember that this medication has been prescribed because your||
0041|077|S|doctor has judged that the benefit to you is greater than the||
0041|078|S|risk of side effects. Many people using this medication do not||
0041|079|S|have serious side effects.||
0041|080|S|   Some people taking this medication have fallen asleep suddenly||
0041|081|S|during their usual daily activities (such as talking on the||
0041|082|S|phone, driving). In some cases, sleep occurred without any||
0041|083|S|feelings of drowsiness beforehand. This sleep effect may occur||
0041|084|S|anytime during treatment with carbidopa/levodopa even if you have||
0041|085|S|used this medication for a long time. If you experience increased||
0041|086|S|sleepiness or fall asleep during the day, do not drive or do||
0041|087|S|other possibly dangerous activities until you have discussed this||
0041|088|S|effect with your doctor. Your risk of this sleep effect is||
0041|089|S|increased by using alcohol or other medications that can make you||
0041|090|S|drowsy. See also Precautions section.||
0041|091|S|   Tell your doctor right away if you have any serious side||
0041|092|S|effects, including: new/worsening movements you can't||
0041|093|S|control/spasms, greatly increased eye blinking/twitching, vision||
0041|094|S|changes (such as blurred vision, double vision), eye pain, severe||
0041|095|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
0041|096|S|coffee grounds, mental/mood changes (such as confusion,||
0041|097|S|agitation, hallucinations), signs of infection (such as sore||
0041|098|S|throat that doesn't go away, fever, chills), easy||
0041|099|S|bleeding/bruising, unusual tiredness, tingling of the hands/feet,||
0041|100|S|unusual strong urges (such as increased gambling, increased||
0041|101|S|sexual urges).||
0041|102|S|   Get medical help right away if you have any very serious side||
0041|103|S|effects, including: chest pain, fainting.||
0041|104|S|   Abruptly stopping or reducing the dose of this medication may||
0041|105|S|rarely cause a very serious condition called neuroleptic||
0041|106|S|malignant syndrome (NMS). Get medical help right away if you have||
0041|107|S|any of the following symptoms: fever, unusual muscle stiffness,||
0041|108|S|severe confusion, sweating, fast/irregular heartbeat.||
0041|109|S|   A very serious allergic reaction to this drug is rare.||
0041|110|S|However, get medical help right away if you notice any symptoms||
0041|111|S|of a serious allergic reaction, including: rash, itching/swelling||
0041|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0041|113|S|breathing.||
0041|114|S|   This is not a complete list of possible side effects. If you||
0041|115|S|notice other effects not listed above, contact your doctor or||
0041|116|S|pharmacist.||
0041|117|S|   In the US -||
0041|118|S|   Call your doctor for medical advice about side effects. You||
0041|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0041|120|S|www.fda.gov/medwatch.||
0041|121|S|   In Canada - Call your doctor for medical advice about side||
0041|122|S|effects. You may report side effects to Health Canada at||
0041|123|S|1-866-234-2345.||
0041|124|B|||
0041|125|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0041|126|P|pharmacist if you are allergic to carbidopa or levodopa; or to||
0041|127|P|foscarbidopa or foslevodopa; or if you have any other allergies.||
0041|128|P|This product may contain inactive ingredients, which can cause||
0041|129|P|allergic reactions or other problems. Talk to your pharmacist for||
0041|130|P|more details.||
0041|131|P|   Before using this medication, tell your doctor or pharmacist||
0041|132|P|your medical history, especially of: liver disease, glaucoma,||
0041|133|P|breathing problems (such as asthma), heart disease (such as heart||
0041|134|P|attack, irregular heartbeat), kidney disease, stomach/intestinal||
0041|135|P|ulcer, mental/mood disorders (such as depression, schizophrenia),||
0041|136|P|blood disorders, seizures, sleep disorders.||
0041|137|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0041|138|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0041|139|P|machinery, or do anything that needs alertness until you can do||
0041|140|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0041|141|P|are using marijuana (cannabis). See also Side Effects section.||
0041|142|P|   Before having surgery, tell your doctor or dentist about all||
0041|143|P|the products you use (including prescription drugs,||
0041|144|P|nonprescription drugs, and herbal products).||
0041|145|P|   During pregnancy, this medication should be used only when||
0041|146|P|clearly needed. Discuss the risks and benefits with your doctor.||
0041|147|P|   Levodopa passes into breast milk. It is unknown if carbidopa||
0041|148|P|passes into breast milk. Consult your doctor before||
0041|149|P|breastfeeding.||
0041|150|B|||
0041|151|I|DRUG INTERACTIONS:  See also How to Use section.||
0041|152|I|   Drug interactions may change how your medications work or||
0041|153|I|increase your risk for serious side effects. This document does||
0041|154|I|not contain all possible drug interactions. Keep a list of all||
0041|155|I|the products you use (including prescription/nonprescription||
0041|156|I|drugs and herbal products) and share it with your doctor and||
0041|157|I|pharmacist. Do not start, stop, or change the dosage of any||
0041|158|I|medicines without your doctor's approval.||
0041|159|I|   Taking MAO inhibitors with this medication may cause a serious||
0041|160|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0041|161|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0041|162|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
0041|163|I|treatment with this medication. Most MAO inhibitors should also||
0041|164|I|not be taken for two weeks before treatment with this medication.||
0041|165|I|However, certain MAO inhibitors (rasagiline, safinamide,||
0041|166|I|selegiline) may be used with careful monitoring by your doctor.||
0041|167|I|Ask your doctor when to start or stop taking this medication.||
0041|168|I|   This medication may interfere with certain lab tests (such as||
0041|169|I|urine catecholamine/glucose/ketone tests), possibly causing false||
0041|170|I|test results. Make sure lab personnel and all your doctors know||
0041|171|I|you use this drug.||
0041|172|B|||
0041|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0041|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0041|175|O|poison control center right away. US residents can call||
0041|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0041|177|O|Symptoms of overdose may include: severe dizziness, irregular||
0041|178|O|heartbeat, mental/mood changes (such as agitation).||
0041|179|B|||
0041|180|N|NOTES:  Do not share this medication with others.||
0041|181|N|   Lab and/or medical tests (such as complete blood count,||
0041|182|N|heart/kidney/liver function, blood pressure) should be done while||
0041|183|N|you are taking this medication. Keep all medical and lab||
0041|184|N|appointments. Consult your doctor for more details.||
0041|185|B|||
0041|186|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0041|187|D|remember. If it is near the time of the next dose, skip the||
0041|188|D|missed dose. Take your next dose at the regular time. Do not||
0041|189|D|double the dose to catch up.||
0041|190|B|||
0041|191|R|STORAGE:  Store at room temperature away from light and moisture.||
0041|192|R|Do not store in the bathroom. Keep all medications away from||
0041|193|R|children and pets.||
0041|194|R|   Do not flush medications down the toilet or pour them into a||
0041|195|R|drain unless instructed to do so. Properly discard this product||
0041|196|R|when it is expired or no longer needed. Consult your pharmacist||
0041|197|R|or local waste disposal company.||
0041|198|B|||
0041|199|A|Information last revised April 2025.||
0041|200|A|Copyright(c) 2025 First Databank, Inc.||
0041|201|B|||
0042|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0042|002|Z|does NOT have all possible information about this product. This||
0042|003|Z|information does not assure that this product is safe, effective,||
0042|004|Z|or appropriate for you. This information is not individual||
0042|005|Z|medical advice and does not substitute for the advice of your||
0042|006|Z|health care professional. Always ask your health care||
0042|007|Z|professional for complete information about this product and your||
0042|008|Z|specific health needs.||
0042|009|B|||
0042|010|T|LITHIUM - ORAL||
0042|011|F|(LITH-ee-um)||
0042|012|B|||
0042|013|C|COMMON BRAND NAME(S): Eskalith||
0042|014|B|||
0042|015|W|WARNING:  It is very important to have the right amount of||
0042|016|W|lithium in your body. Too much lithium may lead to unwanted||
0042|017|W|effects such as nausea, diarrhea, shaking of the hands,||
0042|018|W|dizziness, twitching, seizures, trouble speaking, confusion, or||
0042|019|W|increase in the amount of urine. Tell your doctor right away if||
0042|020|W|these effects occur.||
0042|021|W|   There is only a small difference between the correct amount of||
0042|022|W|lithium and too much lithium. It is important that your doctor||
0042|023|W|monitor you closely during treatment. Keep all medical and lab||
0042|024|W|appointments while you are taking lithium.||
0042|025|B|||
0042|026|U|USES:  This medication is used to treat manic-depressive disorder||
0042|027|U|(bipolar disorder). It works to stabilize the mood and reduce||
0042|028|U|extremes in behavior by restoring the balance of certain natural||
0042|029|U|substances (neurotransmitters) in the brain.||
0042|030|U|   Some of the benefits of continued use of this medication||
0042|031|U|include decreasing how often manic episodes occur and decreasing||
0042|032|U|the symptoms of manic episodes, such as exaggerated feelings of||
0042|033|U|well-being, feelings that others wish to harm you, irritability,||
0042|034|U|anxiousness, rapid/loud speech, and aggressive/hostile behaviors.||
0042|035|B|||
0042|036|V|OTHER USES:  This section contains uses of this drug that are not||
0042|037|V|listed in the approved professional labeling for the drug but||
0042|038|V|that may be prescribed by your health care professional. Use this||
0042|039|V|drug for a condition that is listed in this section only if it||
0042|040|V|has been so prescribed by your health care professional.||
0042|041|V|   This drug may also be used to reduce the risk of a certain||
0042|042|V|type of headache (cluster headache).||
0042|043|B|||
0042|044|H|HOW TO USE:  Read the Medication Guide provided by your||
0042|045|H|pharmacist before you start taking lithium and each time you get||
0042|046|H|a refill. If you have any questions, ask your doctor or||
0042|047|H|pharmacist.||
0042|048|H|   There are different brands and forms of this medication||
0042|049|H|available. They may not have the same effects. Do not change||
0042|050|H|brands or forms without asking your doctor or pharmacist.||
0042|051|H|   Take this medication by mouth as directed by your doctor,||
0042|052|H|usually 3 to 4 times daily for adults and 2 to 3 times daily for||
0042|053|H|children. Take lithium with or right after meals to lessen||
0042|054|H|stomach upset. Drink 8 to 12 glasses (8 ounces/240 milliliters||
0042|055|H|each) of water or other fluid each day, and eat a healthy diet||
0042|056|H|with normal amounts of salt (sodium) as directed by your doctor||
0042|057|H|or dietician while taking this medication. Large changes in the||
0042|058|H|amount of salt in your diet may change your lithium blood levels.||
0042|059|H|Do not change the amount of salt in your diet unless your doctor||
0042|060|H|tells you to do so.||
0042|061|H|   The dosage is based on your medical condition, lithium blood||
0042|062|H|levels, and response to treatment. Children's dosage is also||
0042|063|H|based on weight. For the best effect, take this medication||
0042|064|H|regularly at evenly spaced times. To help you remember, take this||
0042|065|H|medication at the same times every day.||
0042|066|H|   If you are taking the liquid form of this medication,||
0042|067|H|carefully measure the dose using a special measuring||
0042|068|H|device/spoon. Do not use a household spoon because you may not||
0042|069|H|get the correct dose.||
0042|070|H|   This medication must be taken exactly as prescribed. Keep||
0042|071|H|taking this medication even if you feel well. Do not stop taking||
0042|072|H|this drug without consulting your doctor. Some conditions may||
0042|073|H|become worse when this drug is suddenly stopped. Consult your||
0042|074|H|doctor or pharmacist for more details.||
0042|075|H|   Tell your doctor if your condition does not get better or if||
0042|076|H|it gets worse. It may take 1 to 3 weeks to notice improvement in||
0042|077|H|your condition.||
0042|078|B|||
0042|079|S|SIDE EFFECTS:  See also Warning section.||
0042|080|S|   Drowsiness, dizziness, tiredness, increased thirst, increased||
0042|081|S|frequency of urination, weight gain, and mildly shaking hands||
0042|082|S|(fine tremor) may occur. These should go away as your body||
0042|083|S|adjusts to the medication. If any of these effects last or get||
0042|084|S|worse, tell your doctor or pharmacist promptly.||
0042|085|S|   Remember that this medication has been prescribed because your||
0042|086|S|doctor has judged that the benefit to you is greater than the||
0042|087|S|risk of side effects. Many people using this medication do not||
0042|088|S|have serious side effects.||
0042|089|S|   Tell your doctor right away if you have any serious side||
0042|090|S|effects, including: diarrhea, vomiting, unsteady walk, confusion,||
0042|091|S|trouble speaking, blurred vision, severe hand trembling (coarse||
0042|092|S|tremor), vision changes (such as growing blind spot, vision||
0042|093|S|loss), joint swelling/pain, muscle weakness, pain/discoloration||
0042|094|S|of finger/toes, cold hands/feet.||
0042|095|S|   Get medical help right away if you have any very serious side||
0042|096|S|effects, including: severe dizziness, fainting,||
0042|097|S|slow/fast/irregular heartbeat, shortness of breath, seizures.||
0042|098|S|   This medication may increase serotonin and rarely cause a very||
0042|099|S|serious condition called serotonin syndrome/toxicity. The risk||
0042|100|S|increases if you are also taking other drugs that increase||
0042|101|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0042|102|S|take (see Drug Interactions section). Get medical help right away||
0042|103|S|if you develop some of the following symptoms: fast heartbeat,||
0042|104|S|hallucinations, loss of coordination, severe dizziness, severe||
0042|105|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0042|106|S|unusual agitation/restlessness.||
0042|107|S|   A very serious allergic reaction to this drug is rare.||
0042|108|S|However, get medical help right away if you notice any symptoms||
0042|109|S|of a serious allergic reaction, including: swollen lymph nodes,||
0042|110|S|rash, itching/swelling (especially of the face/tongue/throat),||
0042|111|S|severe dizziness, trouble breathing.||
0042|112|S|   This is not a complete list of possible side effects. If you||
0042|113|S|notice other effects not listed above, contact your doctor or||
0042|114|S|pharmacist.||
0042|115|S|   In the US -||
0042|116|S|   Call your doctor for medical advice about side effects. You||
0042|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0042|118|S|www.fda.gov/medwatch.||
0042|119|S|   In Canada - Call your doctor for medical advice about side||
0042|120|S|effects. You may report side effects to Health Canada at||
0042|121|S|1-866-234-2345.||
0042|122|B|||
0042|123|P|PRECAUTIONS:  Before taking lithium, tell your doctor or||
0042|124|P|pharmacist if you are allergic to it; or if you have any other||
0042|125|P|allergies. This product may contain inactive ingredients (such as||
0042|126|P|propylene glycol), which can cause allergic reactions or other||
0042|127|P|problems. Talk to your pharmacist for more details.||
0042|128|P|   Before using this medication, tell your doctor or pharmacist||
0042|129|P|your medical history, especially of: heart disease, kidney||
0042|130|P|disease, urinary problems (such as difficulty urinating),||
0042|131|P|underactive thyroid (hypothyroidism), seizures, Parkinson's||
0042|132|P|disease, leukemia, dehydration, any infection with high fever, a||
0042|133|P|certain skin disorder (such as psoriasis).||
0042|134|P|   Lithium treatment may rarely reveal an existing condition that||
0042|135|P|affects the heart rhythm (Brugada syndrome). Brugada syndrome is||
0042|136|P|an inherited, life-threatening heart problem that some people may||
0042|137|P|have without knowing it. It can cause a serious (possibly fatal)||
0042|138|P|abnormal heartbeat and other symptoms (such as severe dizziness,||
0042|139|P|fainting, shortness of breath) that need medical attention right||
0042|140|P|away. Brugada syndrome may cause death suddenly. Before starting||
0042|141|P|lithium treatment, tell your doctor if you have any of the||
0042|142|P|following risk factors: Brugada syndrome, unexplained fainting,||
0042|143|P|family history of certain heart problems (Brugada syndrome,||
0042|144|P|sudden unexplained death before 45 years old).||
0042|145|P|   This drug may make you dizzy or drowsy or blur your vision.||
0042|146|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0042|147|P|drowsy. Do not drive, use machinery, or do anything that needs||
0042|148|P|alertness or clear vision until you can do it safely. Limit||
0042|149|P|alcoholic beverages. Talk to your doctor if you are using||
0042|150|P|marijuana (cannabis).||
0042|151|P|   If heavy sweating or severe diarrhea occurs, check with your||
0042|152|P|doctor right away how to best keep taking lithium. Take care in||
0042|153|P|hot weather or during activities that cause you to sweat heavily,||
0042|154|P|such as during hot baths, saunas, or exercise.||
0042|155|P|   Before having surgery, tell your doctor or dentist about all||
0042|156|P|the products you use (including prescription drugs,||
0042|157|P|nonprescription drugs, and herbal products).||
0042|158|P|   Tell your doctor if you are pregnant or plan to become||
0042|159|P|pregnant. You should not become pregnant while using lithium.||
0042|160|P|Lithium may harm an unborn baby. However, since untreated||
0042|161|P|mental/mood problems (such as bipolar disorder) can harm a||
0042|162|P|pregnant woman and her unborn baby, do not stop taking this||
0042|163|P|medication unless directed by your doctor. Instead, ask your||
0042|164|P|doctor if a different medication would be right for you. If you||
0042|165|P|are planning pregnancy, become pregnant, or think you may be||
0042|166|P|pregnant, talk to your doctor right away about the risks and||
0042|167|P|benefits of this medication.||
0042|168|P|   Lithium passes into breast milk and may have undesirable||
0042|169|P|effects on a nursing infant. Breastfeeding is not recommended||
0042|170|P|while using this medication. Consult your doctor before||
0042|171|P|breastfeeding.||
0042|172|B|||
0042|173|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0042|174|I|medications work or increase your risk for serious side effects.||
0042|175|I|This document does not contain all possible drug interactions.||
0042|176|I|Keep a list of all the products you use (including||
0042|177|I|prescription/nonprescription drugs and herbal products) and share||
0042|178|I|it with your doctor and pharmacist. Do not start, stop, or change||
0042|179|I|the dosage of any medicines without your doctor's approval.||
0042|180|I|   Other medications can affect the removal of lithium from your||
0042|181|I|body, which may affect how lithium works. Examples include ACE||
0042|182|I|inhibitors (such as captopril, enalapril), ARBs (such as||
0042|183|I|losartan, valsartan), NSAIDs (such as celecoxib, ibuprofen),||
0042|184|I|"water pills" (diuretics such as hydrochlorothiazide,||
0042|185|I|furosemide), other drugs for mental/mood conditions (such as||
0042|186|I|chlorpromazine, haloperidol, thiothixene), among others. Your||
0042|187|I|doctor may need to adjust your dose of lithium if you are on||
0042|188|I|these medications.||
0042|189|I|   The risk of serotonin syndrome/toxicity increases if you are||
0042|190|I|also taking other drugs that increase serotonin. Some examples||
0042|191|I|are street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0042|192|I|antidepressants (such as SSRIs like fluoxetine/paroxetine, SNRIs||
0042|193|I|like duloxetine/venlafaxine), among others. The risk of serotonin||
0042|194|I|syndrome/toxicity may be more likely when you start or increase||
0042|195|I|the dose of these drugs.||
0042|196|I|   Eat a normal diet with an average amount of sodium. Ask your||
0042|197|I|doctor or dietician for more details.||
0042|198|B|||
0042|199|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0042|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0042|201|O|poison control center right away. US residents can call||
0042|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0042|203|O|Symptoms of overdose may include: diarrhea, vomiting, ringing in||
0042|204|O|the ears, blurred vision, trouble walking, unusual drowsiness,||
0042|205|O|seizures, shaking, loss of consciousness.||
0042|206|B|||
0042|207|N|NOTES:  Do not share this medication with others.||
0042|208|N|   Lab and/or medical tests (such as kidney/thyroid function,||
0042|209|N|lithium and calcium blood levels) should be done before you start||
0042|210|N|taking this medication and while you are taking it. Keep all||
0042|211|N|medical and lab appointments. Consult your doctor for more||
0042|212|N|details.||
0042|213|B|||
0042|214|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0042|215|D|remember. If it is within 4 hours of the next dose, skip the||
0042|216|D|missed dose. Take your next dose at the regular time. Do not||
0042|217|D|double the dose to catch up.||
0042|218|B|||
0042|219|R|STORAGE:  Store at room temperature away from light and moisture.||
0042|220|R|Different forms of this medication have different storage||
0042|221|R|temperatures. Consult your pharmacist or the product labeling for||
0042|222|R|more information. Do not freeze liquid forms. Do not store in the||
0042|223|R|bathroom. Keep all medications away from children and pets.||
0042|224|R|   Do not flush medications down the toilet or pour them into a||
0042|225|R|drain unless instructed to do so. Properly discard this product||
0042|226|R|when it is expired or no longer needed. Consult your pharmacist||
0042|227|R|or local waste disposal company.||
0042|228|B|||
0042|229|A|Information last revised May 2024.||
0042|230|A|Copyright(c) 2025 First Databank, Inc.||
0042|231|B|||
0043|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0043|002|Z|does NOT have all possible information about this product. This||
0043|003|Z|information does not assure that this product is safe, effective,||
0043|004|Z|or appropriate for you. This information is not individual||
0043|005|Z|medical advice and does not substitute for the advice of your||
0043|006|Z|health care professional. Always ask your health care||
0043|007|Z|professional for complete information about this product and your||
0043|008|Z|specific health needs.||
0043|009|B|||
0043|010|T|ETHACRYNIC ACID - ORAL||
0043|011|F|(ETH-a-KRIN-ik AS-id)||
0043|012|B|||
0043|013|C|COMMON BRAND NAME(S): Edecrin||
0043|014|B|||
0043|015|U|USES:  Ethacrynic acid is a "water pill" (diuretic) that works in||
0043|016|U|your kidneys to increase the amount of urine you make. This helps||
0043|017|U|your body get rid of extra water. This medication is used to||
0043|018|U|decrease swelling (edema) caused by conditions such as cancer,||
0043|019|U|heart failure, liver disease, and kidney disease. This effect can||
0043|020|U|help your kidneys work better and lessen symptoms such as trouble||
0043|021|U|breathing and swelling in your ankles, feet, hands, or belly.||
0043|022|U|   This medication should not be used for infants.||
0043|023|B|||
0043|024|V|OTHER USES:  This section contains uses of this drug that are not||
0043|025|V|listed in the approved professional labeling for the drug but||
0043|026|V|that may be prescribed by your health care professional. Use this||
0043|027|V|drug for a condition that is listed in this section only if it||
0043|028|V|has been so prescribed by your health care professional.||
0043|029|V|   This drug may also be used for high blood pressure.||
0043|030|B|||
0043|031|H|HOW TO USE:  Take this medication by mouth after a meal as||
0043|032|H|directed by your doctor, usually once or twice a day. If you take||
0043|033|H|this drug too close to bedtime, you may need to wake up to||
0043|034|H|urinate. It is best to take this medication at least 4 hours||
0043|035|H|before your bedtime. Consult your doctor or pharmacist if you||
0043|036|H|have questions about your dosing schedule.||
0043|037|H|   The dosage is based on your medical condition, lab tests, and||
0043|038|H|response to treatment. To reduce your risk of side effects, your||
0043|039|H|doctor may direct you to start this medication at a low dose and||
0043|040|H|gradually increase your dose. Some people may be directed to take||
0043|041|H|this medication every other day or only when needed. Follow your||
0043|042|H|doctor's directions carefully.||
0043|043|H|   If your doctor has directed you to take this medication on a||
0043|044|H|regular schedule, take it regularly to get the most benefit from||
0043|045|H|it. To help you remember, take it at the same time(s) each day.||
0043|046|H|   Tell your doctor if you do not get better or if you get worse.||
0043|047|B|||
0043|048|S|SIDE EFFECTS:  Dizziness, lightheadedness, weakness, muscle||
0043|049|S|cramps, upset stomach, or diarrhea may occur. If any of these||
0043|050|S|effects last or get worse, tell your doctor or pharmacist||
0043|051|S|promptly.||
0043|052|S|   To reduce the risk of dizziness and lightheadedness, get up||
0043|053|S|slowly when rising from a sitting or lying position.||
0043|054|S|   Remember that this medication has been prescribed because your||
0043|055|S|doctor has judged that the benefit to you is greater than the||
0043|056|S|risk of side effects. Many people using this medication do not||
0043|057|S|have serious side effects.||
0043|058|S|   This medication may cause dehydration and electrolyte||
0043|059|S|imbalance. Tell your doctor right away if you notice any symptoms||
0043|060|S|of dehydration or electrolyte imbalance, including unusual dry||
0043|061|S|mouth/thirst, unusual decreased urination, muscle||
0043|062|S|cramps/weakness, slow/fast/irregular heartbeat, or confusion.||
0043|063|S|   Tell your doctor right away if you have any serious side||
0043|064|S|effects, including: easy bleeding/bruising, fainting, feeling of||
0043|065|S|spinning (vertigo), hearing changes (such as ringing or fullness||
0043|066|S|in the ears, decreased hearing/deafness), black/bloody stools,||
0043|067|S|stomach/abdominal pain, vomit that looks like coffee grounds,||
0043|068|S|signs of liver problems (such as nausea/vomiting that doesn't||
0043|069|S|stop, loss of appetite, yellowing eyes/skin, dark urine).||
0043|070|S|   A very serious allergic reaction to this drug is rare.||
0043|071|S|However, get medical help right away if you notice any symptoms||
0043|072|S|of a serious allergic reaction, including: rash, itching/swelling||
0043|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0043|074|S|breathing.||
0043|075|S|   This is not a complete list of possible side effects. If you||
0043|076|S|notice other effects not listed above, contact your doctor or||
0043|077|S|pharmacist.||
0043|078|S|   In the US -||
0043|079|S|   Call your doctor for medical advice about side effects. You||
0043|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0043|081|S|www.fda.gov/medwatch.||
0043|082|S|   In Canada - Call your doctor for medical advice about side||
0043|083|S|effects. You may report side effects to Health Canada at||
0043|084|S|1-866-234-2345.||
0043|085|B|||
0043|086|P|PRECAUTIONS:  Before taking ethacrynic acid, tell your doctor or||
0043|087|P|pharmacist if you are allergic to it; or if you have any other||
0043|088|P|allergies. This product may contain inactive ingredients, which||
0043|089|P|can cause allergic reactions or other problems. Talk to your||
0043|090|P|pharmacist for more details.||
0043|091|P|   Before using this medication, tell your doctor or pharmacist||
0043|092|P|your medical history, especially of: gout, kidney disease, liver||
0043|093|P|disease.||
0043|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0043|095|P|can make you more dizzy. Do not drive, use machinery, or do||
0043|096|P|anything that needs alertness until you can do it safely. Avoid||
0043|097|P|alcoholic beverages. Talk to your doctor if you are using||
0043|098|P|marijuana (cannabis).||
0043|099|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0043|100|P|and cause you to feel lightheaded. Tell your doctor if you have||
0043|101|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0043|102|P|of fluids unless your doctor tells you not to.||
0043|103|P|   This drug can lower certain salt/mineral levels (such as||
0043|104|P|sodium, potassium) in your blood. Your doctor may tell you to use||
0043|105|P|more salt, eat potassium-rich foods (such as bananas, orange||
0043|106|P|juice), or take a potassium supplement. Ask your doctor for more||
0043|107|P|details.||
0043|108|P|   This medication may affect your blood sugar. If you have||
0043|109|P|diabetes, check your blood sugar regularly as directed and share||
0043|110|P|the results with your doctor. Your doctor may need to adjust your||
0043|111|P|diabetes medication, exercise program, or diet.||
0043|112|P|   Before having surgery, tell your doctor or dentist about all||
0043|113|P|the products you use (including prescription drugs,||
0043|114|P|nonprescription drugs, and herbal products).||
0043|115|P|   Older adults may be more sensitive to the side effects of this||
0043|116|P|drug, especially dizziness and water/mineral loss.||
0043|117|P|   During pregnancy, this medication should be used only when||
0043|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
0043|119|P|   It is unknown if this drug passes into breast milk. Consult||
0043|120|P|your doctor before breastfeeding.||
0043|121|B|||
0043|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0043|123|I|medications work or increase your risk for serious side effects.||
0043|124|I|This document does not contain all possible drug interactions.||
0043|125|I|Keep a list of all the products you use (including||
0043|126|I|prescription/nonprescription drugs and herbal products) and share||
0043|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
0043|128|I|the dosage of any medicines without your doctor's approval.||
0043|129|I|   Some products that may interact with this drug include:||
0043|130|I|desmopressin, furosemide, lithium.||
0043|131|I|   Some products have ingredients that could raise your blood||
0043|132|I|pressure or worsen your swelling. Tell your pharmacist what||
0043|133|I|products you are using, and ask how to use them safely||
0043|134|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0043|135|I|ibuprofen/naproxen).||
0043|136|B|||
0043|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0043|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0043|139|O|poison control center right away. US residents can call||
0043|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0043|141|B|||
0043|142|N|NOTES:  Do not share this medication with others.||
0043|143|N|   Lab and/or medical tests (such as kidney function, blood||
0043|144|N|mineral levels such as potassium) should be done while you are||
0043|145|N|taking this medication. Keep all medical and lab appointments.||
0043|146|B|||
0043|147|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
0043|148|D|and miss a dose, take it as soon as you remember. If it is near||
0043|149|D|the time of the next dose, skip the missed dose. Take your next||
0043|150|D|dose at the regular time. Do not double the dose to catch up.||
0043|151|B|||
0043|152|R|STORAGE:  Store at room temperature away from light and moisture.||
0043|153|R|Do not store in the bathroom. Keep all medications away from||
0043|154|R|children and pets.||
0043|155|R|   Do not flush medications down the toilet or pour them into a||
0043|156|R|drain unless instructed to do so. Properly discard this product||
0043|157|R|when it is expired or no longer needed. Consult your pharmacist||
0043|158|R|or local waste disposal company.||
0043|159|B|||
0043|160|A|Information last revised May 2024.||
0043|161|A|Copyright(c) 2025 First Databank, Inc.||
0043|162|B|||
0044|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0044|002|Z|does NOT have all possible information about this product. This||
0044|003|Z|information does not assure that this product is safe, effective,||
0044|004|Z|or appropriate for you. This information is not individual||
0044|005|Z|medical advice and does not substitute for the advice of your||
0044|006|Z|health care professional. Always ask your health care||
0044|007|Z|professional for complete information about this product and your||
0044|008|Z|specific health needs.||
0044|009|B|||
0044|010|T|TRIMETHOPRIM - ORAL||
0044|011|F|(try-METH-oh-prim)||
0044|012|B|||
0044|013|C|COMMON BRAND NAME(S): Primsol, Proloprim, Trimpex||
0044|014|B|||
0044|015|U|USES:  Trimethoprim is an antibiotic used to treat bacterial||
0044|016|U|infections. It works by stopping the growth of bacteria.||
0044|017|U|   This antibiotic treats only bacterial infections. It will not||
0044|018|U|work for viral infections (such as common cold, flu). Using any||
0044|019|U|antibiotic when it is not needed can cause it to not work for||
0044|020|U|future infections.||
0044|021|B|||
0044|022|H|HOW TO USE:  Take this medication by mouth with or without food||
0044|023|H|as directed by your doctor, usually once or twice daily. The||
0044|024|H|dosage is based on your medical condition and response to||
0044|025|H|treatment. Children's dosage is also based on weight.||
0044|026|H|   If you are using the liquid form of this medication, carefully||
0044|027|H|measure the dose using a special measuring device/spoon. Do not||
0044|028|H|use a household spoon because you may not get the correct dose.||
0044|029|H|   For the best effect, take this antibiotic at evenly spaced||
0044|030|H|times. To help you remember, take this medication at the same||
0044|031|H|time(s) every day.||
0044|032|H|   Continue to take this medication until the full prescribed||
0044|033|H|amount is finished, even if symptoms disappear after a few days.||
0044|034|H|Stopping the medication too early may result in a return of the||
0044|035|H|infection.||
0044|036|H|   Tell your doctor if your condition lasts or gets worse after||
0044|037|H|several days.||
0044|038|B|||
0044|039|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, stomach upset, loss of||
0044|040|S|appetite, changes in taste, and headache may occur. If any of||
0044|041|S|these effects last or get worse, tell your doctor or pharmacist||
0044|042|S|promptly.||
0044|043|S|   Remember that this medication has been prescribed because your||
0044|044|S|doctor has judged that the benefit to you is greater than the||
0044|045|S|risk of side effects. Many people using this medication do not||
0044|046|S|have serious side effects.||
0044|047|S|   Tell your doctor right away if you have any serious side||
0044|048|S|effects, including: new signs of infection (such as sore throat||
0044|049|S|that doesn't go away, fever, chills), easy bruising/bleeding,||
0044|050|S|pale skin, unusual tiredness, fast/irregular heartbeat,||
0044|051|S|mental/mood changes, signs of liver disease (such as||
0044|052|S|nausea/vomiting that doesn't stop, dark urine, stomach/abdominal||
0044|053|S|pain, yellowing eyes/skin), stiff neck, headache that doesn't go||
0044|054|S|away, muscle weakness, extreme drowsiness, signs of low blood||
0044|055|S|sugar (such as sudden sweating, shaking, fast heartbeat, hunger,||
0044|056|S|blurred vision, dizziness, or tingling hands/feet).||
0044|057|S|   This medication may rarely cause a severe intestinal condition||
0044|058|S|due to a bacteria called C. difficile. This condition may occur||
0044|059|S|during treatment or weeks to months after treatment has stopped.||
0044|060|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0044|061|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0044|062|S|stool.||
0044|063|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0044|064|S|products because they may make symptoms worse.||
0044|065|S|   Use of this medication for prolonged or repeated periods may||
0044|066|S|result in oral thrush or a new yeast infection. Contact your||
0044|067|S|doctor if you notice white patches in your mouth, a change in||
0044|068|S|vaginal discharge, or other new symptoms.||
0044|069|S|   Get medical help right away if you have any very serious side||
0044|070|S|effects, including: seizures.||
0044|071|S|   A very serious allergic reaction to this drug is rare.||
0044|072|S|However, get medical help right away if you notice any symptoms||
0044|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0044|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0044|075|S|breathing.||
0044|076|S|   This is not a complete list of possible side effects. If you||
0044|077|S|notice other effects not listed above, contact your doctor or||
0044|078|S|pharmacist.||
0044|079|S|   In the US -||
0044|080|S|   Call your doctor for medical advice about side effects. You||
0044|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0044|082|S|www.fda.gov/medwatch.||
0044|083|S|   In Canada - Call your doctor for medical advice about side||
0044|084|S|effects. You may report side effects to Health Canada at||
0044|085|S|1-866-234-2345.||
0044|086|B|||
0044|087|P|PRECAUTIONS:  Before taking trimethoprim, tell your doctor or||
0044|088|P|pharmacist if you are allergic to it; or if you have any other||
0044|089|P|allergies. This product may contain inactive ingredients, which||
0044|090|P|can cause allergic reactions or other problems. Talk to your||
0044|091|P|pharmacist for more details.||
0044|092|P|   Before using this medication, tell your doctor or pharmacist||
0044|093|P|your medical history, especially of: a certain type of anemia||
0044|094|P|(due to folate deficiency), kidney disease, liver disease,||
0044|095|P|vitamin deficiency (folate or folic acid), blood disorders (such||
0044|096|P|as bone marrow suppression, G6PD deficiency), mineral imbalances||
0044|097|P|(such as high level of potassium or low level of sodium in the||
0044|098|P|blood).||
0044|099|P|   This medication may make you more sensitive to the sun. Limit||
0044|100|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0044|101|P|sunscreen and wear protective clothing when outdoors. Tell your||
0044|102|P|doctor right away if you get sunburned or have skin||
0044|103|P|blisters/redness.||
0044|104|P|   If you have diabetes, this product may affect your blood||
0044|105|P|sugar. Check your blood sugar regularly as directed and share the||
0044|106|P|results with your doctor. Tell your doctor right away if you have||
0044|107|P|symptoms of low blood sugar (see Side Effects section). Your||
0044|108|P|doctor may need to adjust your diabetes medication, exercise||
0044|109|P|program, or diet.||
0044|110|P|   Trimethoprim may cause live bacterial vaccines (such as||
0044|111|P|typhoid vaccine) to not work well. Tell your health care||
0044|112|P|professional that you are using trimethoprim before having any||
0044|113|P|immunizations/vaccinations.||
0044|114|P|   Before having surgery, tell your doctor or dentist about all||
0044|115|P|the products you use (including prescription drugs,||
0044|116|P|nonprescription drugs, and herbal products).||
0044|117|P|   Older adults may be more sensitive to the side effects of this||
0044|118|P|drug, especially mineral imbalance (high potassium blood level)||
0044|119|P|and allergic reactions.||
0044|120|P|   Tell your doctor if you are pregnant or plan to become||
0044|121|P|pregnant. You should not become pregnant while using||
0044|122|P|trimethoprim. Trimethoprim may harm an unborn baby. It may lower||
0044|123|P|your folic acid levels, increasing the risk of spinal cord||
0044|124|P|defects. Check with your doctor to make sure you are taking||
0044|125|P|enough folic acid. If you become pregnant, talk to your doctor||
0044|126|P|right away about the risks and benefits of this medication.||
0044|127|P|   Trimethoprim passes into breast milk, but is unlikely to harm||
0044|128|P|a nursing infant. Consult your doctor before breastfeeding.||
0044|129|B|||
0044|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0044|131|I|medications work or increase your risk for serious side effects.||
0044|132|I|This document does not contain all possible drug interactions.||
0044|133|I|Keep a list of all the products you use (including||
0044|134|I|prescription/nonprescription drugs and herbal products) and share||
0044|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
0044|136|I|the dosage of any medicines without your doctor's approval.||
0044|137|I|   A product that may interact with this drug is: dofetilide.||
0044|138|I|   This medication may interfere with certain lab tests||
0044|139|I|(including kidney function and methotrexate blood levels),||
0044|140|I|possibly causing false test results. Make sure lab personnel and||
0044|141|I|all your doctors know you use this drug.||
0044|142|B|||
0044|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0044|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0044|145|O|poison control center right away. US residents can call||
0044|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0044|147|O|Symptoms of overdose may include: mental/mood changes (such as||
0044|148|O|confusion), easy bruising/bleeding.||
0044|149|B|||
0044|150|N|NOTES:  Do not share this medication with others.||
0044|151|N|   This medication has been prescribed for your current condition||
0044|152|N|only. Do not use it later for another infection unless your||
0044|153|N|doctor tells you to.||
0044|154|N|   Lab and/or medical tests (such as complete blood counts,||
0044|155|N|kidney function, potassium blood level, cultures) should be done||
0044|156|N|while you are using this medication. Keep all medical and lab||
0044|157|N|appointments. Consult your doctor for more details.||
0044|158|B|||
0044|159|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0044|160|D|remember. If it is near the time of the next dose, skip the||
0044|161|D|missed dose. Take your next dose at the regular time. Do not||
0044|162|D|double the dose to catch up.||
0044|163|B|||
0044|164|R|STORAGE:  Store at room temperature away from light and moisture.||
0044|165|R|Do not store in the bathroom. Keep all medications away from||
0044|166|R|children and pets.||
0044|167|R|   Do not flush medications down the toilet or pour them into a||
0044|168|R|drain unless instructed to do so. Properly discard this product||
0044|169|R|when it is expired or no longer needed. Consult your pharmacist||
0044|170|R|or local waste disposal company.||
0044|171|B|||
0044|172|A|Information last revised April 2025.||
0044|173|A|Copyright(c) 2025 First Databank, Inc.||
0044|174|B|||
0045|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0045|002|Z|does NOT have all possible information about this product. This||
0045|003|Z|information does not assure that this product is safe, effective,||
0045|004|Z|or appropriate for you. This information is not individual||
0045|005|Z|medical advice and does not substitute for the advice of your||
0045|006|Z|health care professional. Always ask your health care||
0045|007|Z|professional for complete information about this product and your||
0045|008|Z|specific health needs.||
0045|009|B|||
0045|010|T|ISOCARBOXAZID - ORAL||
0045|011|F|(EYE-soe-kar-BOX-a-zid)||
0045|012|B|||
0045|013|C|COMMON BRAND NAME(S): Marplan||
0045|014|B|||
0045|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0045|016|W|of conditions, including depression and other mental/mood||
0045|017|W|disorders. These medications can help prevent suicidal||
0045|018|W|thoughts/attempts and provide other important benefits. However,||
0045|019|W|studies have shown that a small number of people (especially||
0045|020|W|people younger than 25) who take antidepressants for any||
0045|021|W|condition may experience worsening depression, other mental/mood||
0045|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0045|023|W|talk with the doctor about the risks and benefits of||
0045|024|W|antidepressant medication (especially for people younger than||
0045|025|W|25), even if treatment is not for a mental/mood condition.||
0045|026|W|   Tell the doctor right away if you notice worsening||
0045|027|W|depression/other psychiatric conditions, unusual behavior changes||
0045|028|W|(including possible suicidal thoughts/attempts), or other||
0045|029|W|mental/mood changes (including new/worsening anxiety, panic||
0045|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0045|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0045|032|W|especially watchful for these symptoms when a new antidepressant||
0045|033|W|is started or when the dose is changed.||
0045|034|B|||
0045|035|U|USES:  This medication is used to treat depression. Isocarboxazid||
0045|036|U|belongs to a class of drugs known as monoamine oxidase inhibitors||
0045|037|U|(MAO inhibitors). It works by helping to restore the balance of||
0045|038|U|certain natural substances in the brain.||
0045|039|B|||
0045|040|H|HOW TO USE:  Read the Medication Guide provided by your||
0045|041|H|pharmacist before you start using isocarboxazid and each time you||
0045|042|H|get a refill. If you have any questions, ask your doctor or||
0045|043|H|pharmacist.||
0045|044|H|   Take this medication by mouth with or without food as directed||
0045|045|H|by your doctor, usually 2 to 4 times a day. The dosage is based||
0045|046|H|on your medical condition and response to treatment.||
0045|047|H|   To reduce your risk of side effects, your doctor may start you||
0045|048|H|at a low dose and then gradually increase your dose. Once your||
0045|049|H|condition improves and you are better for a while, your doctor||
0045|050|H|may work with you to reduce your regular dose. Follow your||
0045|051|H|doctor's instructions carefully. Do not take more or less||
0045|052|H|medication or take it more often than prescribed. Your condition||
0045|053|H|will not improve any faster and your risk of side effects will||
0045|054|H|increase.||
0045|055|H|   Use this medication regularly in order to get the most benefit||
0045|056|H|from it. To help you remember, use it at the same time(s) each||
0045|057|H|day. It may take several weeks for the full benefits of this||
0045|058|H|medication to be noticed. Do not stop taking this medication||
0045|059|H|without consulting your doctor.||
0045|060|H|   Caffeine can increase the side effects of this medication.||
0045|061|H|Avoid drinking large amounts of beverages containing caffeine||
0045|062|H|(coffee, tea, colas), eating large amounts of chocolate, or||
0045|063|H|taking nonprescription products that contain caffeine.||
0045|064|H|   To prevent a very serious high blood pressure reaction, it is||
0045|065|H|very important that you follow a special diet recommended by your||
0045|066|H|doctor or dietician to limit your intake of tyramine while you||
0045|067|H|are taking this medicine and for at least 2 weeks after the last||
0045|068|H|dose. Avoid foods and beverages that are high in tyramine,||
0045|069|H|including aged cheeses, dried/aged meats and sausages (such as||
0045|070|H|salami, liverwurst), preserved fish (such as pickled herring),||
0045|071|H|products that contain large amounts of yeast (such as bouillon||
0045|072|H|cubes, powdered soup/gravy, homemade or sourdough bread),||
0045|073|H|fermented foods (such as sauerkraut, kim chee), most soybean||
0045|074|H|products (such as soy sauce, tofu), broad/fava beans, red wine,||
0045|075|H|sherry, tap beers, and vermouth. Consult your doctor or dietician||
0045|076|H|for more details and a complete list of other foods that contain||
0045|077|H|tyramine which you should limit or avoid.||
0045|078|H|   If you suddenly stop using this medication, you may have||
0045|079|H|withdrawal symptoms (such as restlessness, confusion,||
0045|080|H|hallucinations, headache, weakness, and diarrhea). To help||
0045|081|H|prevent withdrawal, your doctor may lower your dose slowly.||
0045|082|H|Withdrawal is more likely if you have used isocarboxazid for a||
0045|083|H|long time or in high doses. Tell your doctor or pharmacist right||
0045|084|H|away if you have withdrawal.||
0045|085|H|   Tell your doctor if your condition lasts or gets worse.||
0045|086|B|||
0045|087|S|SIDE EFFECTS:  See also Warning section.||
0045|088|S|   Dizziness, drowsiness, tiredness, weakness, problems sleeping,||
0045|089|S|constipation, and dry mouth may occur. If any of these effects||
0045|090|S|last or get worse, tell your doctor or pharmacist promptly.||
0045|091|S|   To reduce the risk of dizziness and lightheadedness, get up||
0045|092|S|slowly when rising from a sitting or lying position.||
0045|093|S|   Remember that this medication has been prescribed because your||
0045|094|S|doctor has judged that the benefit to you is greater than the||
0045|095|S|risk of side effects. Many people using this medication do not||
0045|096|S|have serious side effects.||
0045|097|S|   Tell your doctor right away if you have any serious side||
0045|098|S|effects, including: fainting, mental/mood changes (such as||
0045|099|S|agitation, confusion), muscle stiffness, changes in sexual||
0045|100|S|ability/interest, shaking (tremor), shivering, swollen||
0045|101|S|ankles/legs, unusual weight gain, eye pain/swelling/redness,||
0045|102|S|vision changes (such as double/blurred vision), signs of liver||
0045|103|S|problems (such as nausea/vomiting that doesn't stop,||
0045|104|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
0045|105|S|seizures.||
0045|106|S|   This drug may rarely cause an attack of extremely high blood||
0045|107|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
0045|108|S|food interactions can increase this risk (See also How to Use and||
0045|109|S|Drug Interaction sections). Stop taking isocarboxazid and get||
0045|110|S|medical help right away if any of these serious side effects||
0045|111|S|occur: frequent/severe headache, fast/slow/irregular/pounding||
0045|112|S|heartbeat, chest pain, neck stiffness/soreness, severe||
0045|113|S|nausea/vomiting, sweating/clammy skin (sometimes with fever),||
0045|114|S|widened pupils, sudden sensitivity to light (photophobia).||
0045|115|S|   This medication may increase serotonin and rarely cause a very||
0045|116|S|serious condition called serotonin syndrome/toxicity. The risk||
0045|117|S|increases if you are also taking other drugs that increase||
0045|118|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0045|119|S|take (see Drug Interactions section). Get medical help right away||
0045|120|S|if you develop some of the following symptoms: fast heartbeat,||
0045|121|S|hallucinations, loss of coordination, severe dizziness, severe||
0045|122|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0045|123|S|unusual agitation/restlessness.||
0045|124|S|   A very serious allergic reaction to this drug is rare.||
0045|125|S|However, get medical help right away if you notice any symptoms||
0045|126|S|of a serious allergic reaction, including: rash, itching/swelling||
0045|127|S|(especially of the face/tongue/throat), dizziness, trouble||
0045|128|S|breathing.||
0045|129|S|   This is not a complete list of possible side effects. If you||
0045|130|S|notice other effects not listed above, contact your doctor or||
0045|131|S|pharmacist.||
0045|132|S|   In the US -||
0045|133|S|   Call your doctor for medical advice about side effects. You||
0045|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0045|135|S|www.fda.gov/medwatch.||
0045|136|S|   In Canada - Call your doctor for medical advice about side||
0045|137|S|effects. You may report side effects to Health Canada at||
0045|138|S|1-866-234-2345.||
0045|139|B|||
0045|140|P|PRECAUTIONS:  Before taking isocarboxazid, tell your doctor or||
0045|141|P|pharmacist if you are allergic to it; or if you have any other||
0045|142|P|allergies. This product may contain inactive ingredients, which||
0045|143|P|can cause allergic reactions or other problems. Talk to your||
0045|144|P|pharmacist for more details.||
0045|145|P|   Before using this medication, tell your doctor or pharmacist||
0045|146|P|your medical history, especially of: a certain adrenal gland||
0045|147|P|tumor (pheochromocytoma), cerebrovascular disease (such as||
0045|148|P|stroke), high blood pressure, history of severe/frequent||
0045|149|P|headaches, liver problems, personal/family history of mental/mood||
0045|150|P|disorders (such as schizophrenia, bipolar disorder), heart||
0045|151|P|disease (such as heart failure, heart attack, coronary artery||
0045|152|P|disease), kidney disease, certain nervous system diseases||
0045|153|P|(Parkinson's syndrome, seizures), overactive thyroid||
0045|154|P|(hyperthyroidism), personal/family history of glaucoma||
0045|155|P|(angle-closure type).||
0045|156|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0045|157|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0045|158|P|machinery, or do anything that needs alertness until you can do||
0045|159|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0045|160|P|are using marijuana (cannabis).||
0045|161|P|   Before having surgery or any procedures requiring use of||
0045|162|P|contrast dye (such as myelography), tell your doctor or dentist||
0045|163|P|about all the products you use (including prescription drugs,||
0045|164|P|nonprescription drugs, and herbal products). You may need to stop||
0045|165|P|taking this drug beforehand. Follow your doctor's instructions||
0045|166|P|carefully.||
0045|167|P|   If you have heart disease, this medication may mask chest||
0045|168|P|pain. Avoid strenuous exercise while taking this medication.||
0045|169|P|   If you have diabetes, isocarboxazid may lower your blood||
0045|170|P|sugar. Check your blood sugar regularly as directed and share the||
0045|171|P|results with your doctor. Tell your doctor right away if you have||
0045|172|P|symptoms of low blood sugar such as sudden sweating, shaking,||
0045|173|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
0045|174|P|hands/feet. Your doctor may need to adjust your diabetes||
0045|175|P|medication, exercise program, or diet.||
0045|176|P|   Older adults may be more sensitive to the side effects of this||
0045|177|P|drug, especially the effects on blood pressure.||
0045|178|P|   During pregnancy, this medication should be used only when||
0045|179|P|clearly needed. Discuss the risks and benefits with your doctor.||
0045|180|P|   Since untreated mental/mood problems (such as depression) can||
0045|181|P|be a serious condition, do not stop taking this medication unless||
0045|182|P|directed by your doctor. If you are planning pregnancy, become||
0045|183|P|pregnant, or think you may be pregnant, immediately discuss with||
0045|184|P|your doctor the benefits and risks of using this medication||
0045|185|P|during pregnancy.||
0045|186|P|   It is unknown if this drug passes into breast milk. Consult||
0045|187|P|your doctor before breastfeeding.||
0045|188|B|||
0045|189|I|DRUG INTERACTIONS:  See also How to Use section.||
0045|190|I|   Drug interactions may change how your medications work or||
0045|191|I|increase your risk for serious side effects. This document does||
0045|192|I|not contain all possible drug interactions. Keep a list of all||
0045|193|I|the products you use (including prescription/nonprescription||
0045|194|I|drugs and herbal products) and share it with your doctor and||
0045|195|I|pharmacist. Do not start, stop, or change the dosage of any||
0045|196|I|medicines without your doctor's approval.||
0045|197|I|   Some products that may interact with this drug include: other||
0045|198|I|antidepressants (including maprotiline, mirtazapine, nefazodone,||
0045|199|I|TCAs such as amitriptyline/nortriptyline), appetite suppressants||
0045|200|I|(such as diethylpropion), drugs for attention deficit disorder||
0045|201|I|(such as atomoxetine, methylphenidate), apraclonidine, bupropion,||
0045|202|I|buspirone, carbamazepine, cyclobenzaprine, deutetrabenazine,||
0045|203|I|dextromethorphan, certain drugs for high blood pressure (such as||
0045|204|I|guanethidine, methyldopa, beta blockers such as atenolol,||
0045|205|I|clonidine, rauwolfia alkaloids), other MAO inhibitors (linezolid,||
0045|206|I|metaxalone, methylene blue, moclobemide, phenelzine,||
0045|207|I|procarbazine, rasagiline, safinamide, selegiline,||
0045|208|I|tranylcypromine), metoclopramide, certain opioid medications||
0045|209|I|(such as fentanyl, methadone, tapentadol), certain drugs for||
0045|210|I|Parkinson's (such as entacapone, levodopa, tolcapone), street||
0045|211|I|drugs (such as LSD, mescaline), tetrabenazine, "triptan" migraine||
0045|212|I|drugs (such as sumatriptan, rizatriptan), tramadol, tyrosine,||
0045|213|I|tryptophan, valbenazine.||
0045|214|I|   The risk of serotonin syndrome/toxicity increases if you are||
0045|215|I|also taking other drugs that increase serotonin. Examples include||
0045|216|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
0045|217|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0045|218|I|SNRIs such as duloxetine/venlafaxine), meperidine, among others.||
0045|219|I|The risk of serotonin syndrome/toxicity may be more likely when||
0045|220|I|you start or increase the dose of these drugs.||
0045|221|I|   Tell your doctor or pharmacist if you are using any of these||
0045|222|I|medications before, during, or within 2 weeks after treatment||
0045|223|I|with isocarboxazid. Tell your doctor or pharmacist if you have||
0045|224|I|taken fluoxetine during at least 5 weeks before starting||
0045|225|I|isocarboxazid. Discuss with your doctor how much time to wait||
0045|226|I|between starting or stopping any of these drugs and taking||
0045|227|I|isocarboxazid.||
0045|228|I|   Before using isocarboxazid, report the use of drugs that may||
0045|229|I|increase the risk of extremely high blood pressure (hypertensive||
0045|230|I|crisis) when combined with isocarboxazid, including herbal||
0045|231|I|products (such as ephedra/ma huang), nasal decongestants (such as||
0045|232|I|phenylephrine, pseudoephedrine), and stimulants (such as||
0045|233|I|amphetamines, ephedrine, epinephrine, phenylalanine).||
0045|234|I|Isocarboxazid should not be used with any of these medications.||
0045|235|I|Talk to your doctor or pharmacist for more details.||
0045|236|I|   Tell your doctor or pharmacist if you are taking other||
0045|237|I|products that cause drowsiness such as opioid pain or cough||
0045|238|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0045|239|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0045|240|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0045|241|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0045|242|I|diphenhydramine).||
0045|243|I|   Check the labels on all your medicines (such as allergy,||
0045|244|I|cough-and-cold products, diet pills) because they may contain||
0045|245|I|dextromethorphan, decongestants, stimulants, or ingredients that||
0045|246|I|cause drowsiness. Ask your pharmacist about the safe use of those||
0045|247|I|products.||
0045|248|B|||
0045|249|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0045|250|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0045|251|O|poison control center right away. US residents can call||
0045|252|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0045|253|B|||
0045|254|N|NOTES:  Do not share this medication with others.||
0045|255|N|   Lab and/or medical tests (such as blood pressure, liver||
0045|256|N|function) should be done while you are taking this medication.||
0045|257|N|Keep all medical and lab appointments. Consult your doctor for||
0045|258|N|more details.||
0045|259|B|||
0045|260|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0045|261|D|remember. If it is within 2 hours of the next dose, skip the||
0045|262|D|missed dose. Take your next dose at the regular time. Do not||
0045|263|D|double the dose to catch up.||
0045|264|B|||
0045|265|R|STORAGE:  Store at room temperature away from light and moisture.||
0045|266|R|Do not store in the bathroom. Keep all medications away from||
0045|267|R|children and pets.||
0045|268|R|   Do not flush medications down the toilet or pour them into a||
0045|269|R|drain unless instructed to do so. Properly discard this product||
0045|270|R|when it is expired or no longer needed. Consult your pharmacist||
0045|271|R|or local waste disposal company.||
0045|272|B|||
0045|273|M|MEDICAL ALERT:  Your condition can cause complications in a||
0045|274|M|medical emergency. For information about enrolling in MedicAlert,||
0045|275|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0045|276|B|||
0045|277|A|Information last revised November 2025.||
0045|278|A|Copyright(c) 2025 First Databank, Inc.||
0045|279|B|||
0046|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0046|002|Z|does NOT have all possible information about this product. This||
0046|003|Z|information does not assure that this product is safe, effective,||
0046|004|Z|or appropriate for you. This information is not individual||
0046|005|Z|medical advice and does not substitute for the advice of your||
0046|006|Z|health care professional. Always ask your health care||
0046|007|Z|professional for complete information about this product and your||
0046|008|Z|specific health needs.||
0046|009|B|||
0046|010|T|METHOTREXATE - ORAL||
0046|011|F|(METH-oh-TREX-ate)||
0046|012|B|||
0046|013|C|COMMON BRAND NAME(S):  Rheumatrex, Jylamvo, Trexall, Xatmep||
0046|014|B|||
0046|015|W|WARNING:  Methotrexate has rarely caused serious (sometimes||
0046|016|W|fatal) side effects. This medication should be used only to treat||
0046|017|W|cancer or severe diseases caused by an overactive immune system||
0046|018|W|(such as psoriasis, rheumatoid arthritis).||
0046|019|W|   Methotrexate has caused birth defects and death in unborn||
0046|020|W|babies. Women must avoid becoming pregnant while taking this||
0046|021|W|medication. Pregnant women who have psoriasis or rheumatoid||
0046|022|W|arthritis must not use methotrexate. (See also Precautions||
0046|023|W|section.)||
0046|024|W|   If you have kidney problems or excess body water (ascites,||
0046|025|W|pleural effusion), you must be closely monitored and your dose||
0046|026|W|may be adjusted or stopped by your doctor.||
0046|027|W|   Methotrexate (usually at high dosages) has rarely caused||
0046|028|W|severe (sometimes fatal) blood/bone marrow problems (decreasing||
0046|029|W|your body's ability to fight infections) and stomach/intestinal||
0046|030|W|disease (such as bleeding) when used at the same time as||
0046|031|W|non-steroidal anti-inflammatory drugs (NSAIDs such as||
0046|032|W|indomethacin, ketoprofen). NSAIDs should not be used with||
0046|033|W|high-dose methotrexate. Caution is advised if you also take||
0046|034|W|aspirin. NSAIDs/aspirin may be used with low-dose methotrexate||
0046|035|W|such as for the treatment of rheumatoid arthritis if directed by||
0046|036|W|your doctor. If your doctor has told you to take low-dose aspirin||
0046|037|W|to prevent heart attack or stroke (usually 81-162 milligrams a||
0046|038|W|day), you should keep taking the aspirin unless your doctor tells||
0046|039|W|you not to. Ask your doctor or pharmacist for more details on the||
0046|040|W|safe use of these drugs (such as close monitoring by your doctor,||
0046|041|W|keeping the same doses of NSAIDs).||
0046|042|W|   In rare instances, this drug may also cause liver problems||
0046|043|W|when it is used for long periods of time. If you are using||
0046|044|W|methotrexate long term, a liver biopsy is usually recommended.||
0046|045|W|   Methotrexate use has rarely caused serious (sometimes fatal)||
0046|046|W|side effects, such as lung problems, lung infections||
0046|047|W|(Pneumocystis jiroveci pneumonia), skin reactions, diarrhea, and||
0046|048|W|mouth sores (ulcerative stomatitis). (See also Side Effects||
0046|049|W|section.)||
0046|050|W|   Lumps (tumors/abnormal growths) may very rarely appear during||
0046|051|W|methotrexate use. The drug must be stopped and treatment may be||
0046|052|W|needed. Tell your doctor right away if new lumps/growths occur.||
0046|053|W|   When used to treat tumors, methotrexate sometimes causes side||
0046|054|W|effects due to the rapid destruction of cancer cells (tumor lysis||
0046|055|W|syndrome). To lower your risk, drink plenty of fluids unless your||
0046|056|W|doctor directs you otherwise. Also, your doctor may prescribe an||
0046|057|W|additional medication. Tell your doctor right away if you have||
0046|058|W|symptoms such as irregular heartbeat, low back/side pain, signs||
0046|059|W|of kidney problems (such as pink/bloody urine, change in the||
0046|060|W|amount of urine, painful urination), or muscle spasms/weakness.||
0046|061|W|   When this medication is used with radiation treatment, it may||
0046|062|W|rarely increase the risk of tissue and bone damage. Discuss the||
0046|063|W|risks and benefits of your treatment with your doctor.||
0046|064|B|||
0046|065|U|USES:  Methotrexate is used to treat certain types of cancer||
0046|066|U|(such as acute lymphoblastic leukemia, non-Hodgkin's lymphoma),||
0046|067|U|severe psoriasis that has not responded to other treatments, or||
0046|068|U|rheumatoid arthritis. It may also be used to treat a certain type||
0046|069|U|of arthritis in children (polyarticular juvenile idiopathic||
0046|070|U|arthritis - pJIA). Methotrexate belongs to a class of drugs known||
0046|071|U|as antimetabolites. It works by slowing or stopping the growth of||
0046|072|U|cancer cells and blocking the immune system from attacking||
0046|073|U|healthy tissue.||
0046|074|U|   Early treatment of rheumatoid arthritis with methotrexate||
0046|075|U|helps to reduce further joint damage and to preserve joint||
0046|076|U|function.||
0046|077|B|||
0046|078|V|OTHER USES:  This section contains uses of this drug that are not||
0046|079|V|listed in the approved professional labeling for the drug but||
0046|080|V|that may be prescribed by your health care professional. Use this||
0046|081|V|drug for a condition that is listed in this section only if it||
0046|082|V|has been so prescribed by your health care professional.||
0046|083|V|   This medication may also be used for lupus and psoriatic||
0046|084|V|arthritis.||
0046|085|B|||
0046|086|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0046|087|H|from your pharmacist before you start taking methotrexate and||
0046|088|H|each time you get a refill. If you have any questions, ask your||
0046|089|H|doctor or pharmacist.||
0046|090|H|   Methotrexate is a strong medication. The dosage and how often||
0046|091|H|you take this medication are based on your medical condition and||
0046|092|H|response to treatment. There are many different dosing schedules||
0046|093|H|for this medication (especially for cancer treatment). Taking||
0046|094|H|this medication the wrong way may cause serious side effects,||
0046|095|H|including death. It is very important that you follow your||
0046|096|H|doctor's instructions carefully. Take this medication by mouth as||
0046|097|H|directed by your doctor.||
0046|098|H|   For the treatment of psoriasis or rheumatoid arthritis, take||
0046|099|H|this medication by mouth as directed by your doctor, usually once||
0046|100|H|a week. It may take up to several months before you get the full||
0046|101|H|benefit of this drug.||
0046|102|H|   If you are using the liquid form of this medication, carefully||
0046|103|H|measure the dose using a special measuring device/spoon. Do not||
0046|104|H|use a household spoon because you may not get the correct dose.||
0046|105|H|   Do not increase your dose or use this drug more often or for||
0046|106|H|longer than prescribed. Your condition will not improve any||
0046|107|H|faster, and your risk of side effects will increase.||
0046|108|H|   Since this drug can be absorbed through the skin and lungs and||
0046|109|H|may harm an unborn baby, women who are pregnant or who may become||
0046|110|H|pregnant should not handle this medication or breathe the dust||
0046|111|H|from the tablets.||
0046|112|H|   Drink plenty of fluids while taking this medication unless||
0046|113|H|your doctor tells you otherwise. Doing so helps your kidneys to||
0046|114|H|remove the drug from your body and avoid some of the side||
0046|115|H|effects.||
0046|116|B|||
0046|117|S|SIDE EFFECTS:  See also Warning section.||
0046|118|S|   Nausea, vomiting, stomach pain, drowsiness, or dizziness may||
0046|119|S|occur. If any of these effects last or get worse, tell your||
0046|120|S|doctor or pharmacist promptly.||
0046|121|S|   Temporary hair loss may occur. Normal hair growth should||
0046|122|S|return after treatment has ended.||
0046|123|S|   Remember that this medication has been prescribed because your||
0046|124|S|doctor has judged that the benefit to you is greater than the||
0046|125|S|risk of side effects. Many people using this medication do not||
0046|126|S|have serious side effects.||
0046|127|S|   Tell your doctor right away if you have any serious side||
0046|128|S|effects, including: mouth sores, diarrhea, signs of anemia (such||
0046|129|S|as unusual tiredness, pale skin), signs of liver problems (such||
0046|130|S|as nausea/vomiting that doesn't stop, dark urine,||
0046|131|S|stomach/abdominal pain, yellowing eyes/skin), easy||
0046|132|S|bruising/bleeding, black stools, swollen lymph nodes, bone pain,||
0046|133|S|unusual pain and discoloration of the skin, signs of kidney||
0046|134|S|problems (such as change in the amount of urine), dry cough,||
0046|135|S|muscle weakness.||
0046|136|S|   Get medical help right away if you have any very serious side||
0046|137|S|effects, including: weakness on one side of the body, neck||
0046|138|S|stiffness, severe headache, vision changes, irregular heartbeat,||
0046|139|S|mental/mood changes, seizures.||
0046|140|S|   This medication may lower your ability to fight infections.||
0046|141|S|This may make you more likely to get a serious (rarely fatal)||
0046|142|S|infection or make any infection you have worse. Tell your doctor||
0046|143|S|right away if you have any signs of infection (such as sore||
0046|144|S|throat that doesn't go away, fever, chills).||
0046|145|S|   A very serious allergic reaction to this drug is rare.||
0046|146|S|However, get medical help right away if you notice any symptoms||
0046|147|S|of a serious allergic reaction, including: rash, itching/swelling||
0046|148|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0046|149|S|breathing.||
0046|150|S|   This is not a complete list of possible side effects. If you||
0046|151|S|notice other effects not listed above, contact your doctor or||
0046|152|S|pharmacist.||
0046|153|S|   In the US -||
0046|154|S|   Call your doctor for medical advice about side effects. You||
0046|155|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0046|156|S|www.fda.gov/medwatch.||
0046|157|S|   In Canada - Call your doctor for medical advice about side||
0046|158|S|effects. You may report side effects to Health Canada at||
0046|159|S|1-866-234-2345.||
0046|160|B|||
0046|161|P|PRECAUTIONS:  See also Warning section.||
0046|162|P|   Before taking methotrexate, tell your doctor or pharmacist if||
0046|163|P|you are allergic to it; or if you have any other allergies. This||
0046|164|P|product may contain inactive ingredients, which can cause||
0046|165|P|allergic reactions or other problems. Talk to your pharmacist for||
0046|166|P|more details.||
0046|167|P|   Before using this medication, tell your doctor or pharmacist||
0046|168|P|your medical history, especially of: liver disease, kidney||
0046|169|P|disease, lung disease (such as pulmonary fibrosis), alcohol use,||
0046|170|P|suppressed immune system, blood cell/bone marrow disorders,||
0046|171|P|stomach/intestinal diseases (such as peptic ulcer, ulcerative||
0046|172|P|colitis), any active infection (including chickenpox or recent||
0046|173|P|exposure to it), folic acid deficiency.||
0046|174|P|   Methotrexate can make you more likely to get infections or may||
0046|175|P|make current infections worse. Stay away from anyone who has an||
0046|176|P|infection that may easily spread (such as chickenpox, COVID-19,||
0046|177|P|measles, flu). Talk to your doctor if you have been exposed to an||
0046|178|P|infection or for more details.||
0046|179|P|   Tell your health care professional that you are using||
0046|180|P|methotrexate before having any immunizations/vaccinations. Avoid||
0046|181|P|contact with people who have recently received live vaccines||
0046|182|P|(such as flu vaccine inhaled through the nose).||
0046|183|P|   To lower the chance of getting cut, bruised, or injured, use||
0046|184|P|caution with sharp objects like razors and nail cutters, and||
0046|185|P|avoid activities such as contact sports.||
0046|186|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0046|187|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0046|188|P|machinery, or do anything that needs alertness until you can do||
0046|189|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0046|190|P|are using marijuana (cannabis).||
0046|191|P|   Before having surgery, tell your doctor or dentist about all||
0046|192|P|the products you use (including prescription drugs,||
0046|193|P|nonprescription drugs, and herbal products).||
0046|194|P|   This medication may make you more sensitive to the sun. Limit||
0046|195|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0046|196|P|sunscreen and wear protective clothing when outdoors. Tell your||
0046|197|P|doctor right away if you get sunburned or have skin||
0046|198|P|blisters/redness.||
0046|199|P|   This medication can affect fertility in both males and||
0046|200|P|females. Ask your doctor for more details.||
0046|201|P|   Methotrexate must not be used during pregnancy. It may harm an||
0046|202|P|unborn baby. Your doctor should order a pregnancy test before you||
0046|203|P|start this medication. You should not become pregnant while using||
0046|204|P|methotrexate. Women using this medication should ask about||
0046|205|P|reliable forms of birth control during treatment and for 6 months||
0046|206|P|after the last dose. Men using this medication should ask about||
0046|207|P|reliable forms of birth control during treatment and for 3 months||
0046|208|P|after the last dose. If you or your partner become pregnant, or||
0046|209|P|think you are pregnant, talk to your doctor right away about the||
0046|210|P|risks and benefits of this medication.||
0046|211|P|   Since this drug can be absorbed through the skin and lungs and||
0046|212|P|may harm an unborn baby, women who are pregnant or who may become||
0046|213|P|pregnant should not handle this medication or breathe the dust||
0046|214|P|from the tablets.||
0046|215|P|   Methotrexate passes into breast milk and may harm a nursing||
0046|216|P|infant. Breastfeeding is not recommended while using this||
0046|217|P|medication and for at least 1 week after the last dose. Consult||
0046|218|P|your doctor before breastfeeding.||
0046|219|B|||
0046|220|I|DRUG INTERACTIONS:  See also Warning section.||
0046|221|I|   Drug interactions may change how your medications work or||
0046|222|I|increase your risk for serious side effects. This document does||
0046|223|I|not contain all possible drug interactions. Keep a list of all||
0046|224|I|the products you use (including prescription/nonprescription||
0046|225|I|drugs and herbal products) and share it with your doctor and||
0046|226|I|pharmacist. Do not start, stop, or change the dosage of any||
0046|227|I|medicines without your doctor's approval.||
0046|228|I|   Some products that may interact with this drug include:||
0046|229|I|acitretin, asparaginase, leflunomide.||
0046|230|I|   Other medications can affect the removal of methotrexate from||
0046|231|I|your body, which may affect how methotrexate works. Examples||
0046|232|I|include penicillins, probenecid, proton pump inhibitors-PPIs||
0046|233|I|(such as esomeprazole, omeprazole, pantoprazole), sulfa||
0046|234|I|medications, among others.||
0046|235|B|||
0046|236|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0046|237|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0046|238|O|poison control center right away. US residents can call||
0046|239|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0046|240|O|Symptoms of overdose may include severe nausea and vomiting, and||
0046|241|O|bloody stools.||
0046|242|B|||
0046|243|N|NOTES:  Do not share this medication with others.||
0046|244|N|   Lab and/or medical tests (such as complete blood cell counts,||
0046|245|N|liver/kidney function, pregnancy test, chest X-ray) should be||
0046|246|N|done before you start taking this medication and while you are||
0046|247|N|taking it. Keep all medical and lab appointments. Consult your||
0046|248|N|doctor for more details.||
0046|249|B|||
0046|250|D|MISSED DOSE:  It is important to take each dose of this||
0046|251|D|medication as scheduled. If you miss a dose, ask your doctor or||
0046|252|D|pharmacist right away for a new dosing schedule. Do not double||
0046|253|D|the dose to catch up.||
0046|254|B|||
0046|255|R|STORAGE:  Store tablets at room temperature away from light and||
0046|256|R|moisture. Do not store in the bathroom. For the liquid form,||
0046|257|R|check the product package for instructions on how to store your||
0046|258|R|brand, or ask your pharmacist. Keep all medications away from||
0046|259|R|children and pets.||
0046|260|R|   Do not flush medications down the toilet or pour them into a||
0046|261|R|drain unless instructed to do so. Properly discard this product||
0046|262|R|when it is expired or no longer needed. Consult your pharmacist||
0046|263|R|or local waste disposal company.||
0046|264|B|||
0046|265|M|MEDICAL ALERT:  Your condition can cause complications in a||
0046|266|M|medical emergency. For information about enrolling in MedicAlert,||
0046|267|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0046|268|B|||
0046|269|A|Information last revised August 2025.||
0046|270|A|Copyright(c) 2025 First Databank, Inc.||
0046|271|B|||
0047|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0047|002|Z|does NOT have all possible information about this product. This||
0047|003|Z|information does not assure that this product is safe, effective,||
0047|004|Z|or appropriate for you. This information is not individual||
0047|005|Z|medical advice and does not substitute for the advice of your||
0047|006|Z|health care professional. Always ask your health care||
0047|007|Z|professional for complete information about this product and your||
0047|008|Z|specific health needs.||
0047|009|B|||
0047|010|T|DOXEPIN LIQUID - ORAL||
0047|011|F|(DOX-e-pin)||
0047|012|B|||
0047|013|C|COMMON BRAND NAME(S): Sinequan||
0047|014|B|||
0047|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0047|016|W|of conditions, including depression and other mental/mood||
0047|017|W|disorders. These medications can help prevent suicidal||
0047|018|W|thoughts/attempts and provide other important benefits. However,||
0047|019|W|studies have shown that a small number of people (especially||
0047|020|W|people younger than 25) who take antidepressants for any||
0047|021|W|condition may experience worsening depression, other mental/mood||
0047|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0047|023|W|talk with the doctor about the risks and benefits of||
0047|024|W|antidepressant medication (especially for people younger than||
0047|025|W|25), even if treatment is not for a mental/mood condition. Tell||
0047|026|W|the doctor right away if you notice worsening depression/other||
0047|027|W|psychiatric conditions, unusual behavior changes (including||
0047|028|W|possible suicidal thoughts/attempts), or other mental/mood||
0047|029|W|changes (including new/worsening anxiety, panic attacks, trouble||
0047|030|W|sleeping, irritability, hostile/angry feelings, impulsive||
0047|031|W|actions, severe restlessness, very rapid speech). Be especially||
0047|032|W|watchful for these symptoms when a new antidepressant is started||
0047|033|W|or when the dose is changed.||
0047|034|B|||
0047|035|U|USES:  This medication is used to treat certain mental/mood||
0047|036|U|disorders (such as depression, anxiety). Doxepin belongs to a||
0047|037|U|class of drugs known as tricyclic antidepressants. It works by||
0047|038|U|helping to restore the balance of certain natural substances in||
0047|039|U|the brain.||
0047|040|B|||
0047|041|H|HOW TO USE:  Read the Medication Guide provided by your||
0047|042|H|pharmacist before you start taking doxepin and each time you get||
0047|043|H|a refill. If you have any questions, consult your doctor or||
0047|044|H|pharmacist.||
0047|045|H|   Take this medication by mouth as directed by your doctor,||
0047|046|H|usually 1 to 3 times daily. If you take it only once a day, take||
0047|047|H|it at bedtime to reduce daytime sleepiness. The dosage is based||
0047|048|H|on your medical condition and response to treatment.||
0047|049|H|   To reduce your risk of side effects (such as drowsiness, dry||
0047|050|H|mouth, dizziness), your doctor may direct you to start this||
0047|051|H|medication at a low dose and gradually increase your dose. Follow||
0047|052|H|your doctor's instructions carefully.||
0047|053|H|   Use the dropper that comes with the medication to measure out||
0047|054|H|the prescribed amount. Then mix with half a glass (4 ounces or||
0047|055|H|120 milliliters) of water or milk, or orange, grapefruit, tomato,||
0047|056|H|prune, or pineapple juice, and drink all of the mixture right||
0047|057|H|away. Do not mix with any other liquids. Do not prepare a supply||
0047|058|H|in advance.||
0047|059|H|   Take this medication regularly in order to get the most||
0047|060|H|benefit from it. To help you remember, take it at the same||
0047|061|H|time(s) each day. Do not increase your dose or use this drug more||
0047|062|H|often or for longer than prescribed. Your condition will not||
0047|063|H|improve any faster, and your risk of side effects will increase.||
0047|064|H|   Keep taking this medication even if you feel well. Do not stop||
0047|065|H|taking this medication without consulting your doctor. Some||
0047|066|H|conditions may become worse when this drug is suddenly stopped.||
0047|067|H|Also, you may experience symptoms such as mood swings, headache,||
0047|068|H|and tiredness. To prevent these symptoms while you are stopping||
0047|069|H|treatment with this drug, your doctor may reduce your dose||
0047|070|H|gradually. Consult your doctor or pharmacist for more details.||
0047|071|H|Report any new or worsening symptoms right away.||
0047|072|H|   This medication may not work right away. You may see some||
0047|073|H|benefit within a week. However, it may take up to 3 weeks before||
0047|074|H|you feel the full effect.||
0047|075|H|   Tell your doctor if your condition lasts or gets worse (such||
0047|076|H|as your feelings of sadness get worse, or you have thoughts of||
0047|077|H|suicide).||
0047|078|B|||
0047|079|S|SIDE EFFECTS:  See also Warning section.||
0047|080|S|   Drowsiness, dizziness, dry mouth, blurred vision,||
0047|081|S|constipation, or trouble urinating may occur. If any of these||
0047|082|S|effects last or get worse, notify your doctor or pharmacist||
0047|083|S|promptly.||
0047|084|S|   To reduce the risk of dizziness and lightheadedness, get up||
0047|085|S|slowly when rising from a sitting or lying position.||
0047|086|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0047|087|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0047|088|S|substitute.||
0047|089|S|   To prevent constipation, eat dietary fiber, drink enough||
0047|090|S|water, and exercise. You may also need to take a laxative. Ask||
0047|091|S|your pharmacist which type of laxative is right for you.||
0047|092|S|   Remember that this medication has been prescribed because your||
0047|093|S|doctor has judged that the benefit to you is greater than the||
0047|094|S|risk of side effects. Many people using this medication do not||
0047|095|S|have serious side effects.||
0047|096|S|   Tell your doctor right away if you have any serious side||
0047|097|S|effects, including: heartburn that doesn't go away, mental/mood||
0047|098|S|changes (such as anxiety, confusion), shaking, severe||
0047|099|S|stomach/abdominal pain.||
0047|100|S|   Get medical help right away if you have any very serious side||
0047|101|S|effects, including: irregular heartbeat, fainting, seizures, eye||
0047|102|S|pain/swelling/redness, widened pupils, vision changes (such as||
0047|103|S|seeing rainbows around lights at night).||
0047|104|S|   This medication may increase serotonin and rarely cause a very||
0047|105|S|serious condition called serotonin syndrome/toxicity. The risk||
0047|106|S|increases if you are also taking other drugs that increase||
0047|107|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0047|108|S|take (see Drug Interactions section). Get medical help right away||
0047|109|S|if you develop some of the following symptoms: fast heartbeat,||
0047|110|S|hallucinations, loss of coordination, severe dizziness, severe||
0047|111|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0047|112|S|unusual agitation/restlessness.||
0047|113|S|   A very serious allergic reaction to this drug is rare.||
0047|114|S|However, get medical help right away if you notice any symptoms||
0047|115|S|of a serious allergic reaction, including: rash, itching/swelling||
0047|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0047|117|S|breathing.||
0047|118|S|   This is not a complete list of possible side effects. If you||
0047|119|S|notice other effects not listed above, contact your doctor or||
0047|120|S|pharmacist.||
0047|121|S|   In the US -||
0047|122|S|   Call your doctor for medical advice about side effects. You||
0047|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0047|124|S|www.fda.gov/medwatch.||
0047|125|S|   In Canada - Call your doctor for medical advice about side||
0047|126|S|effects. You may report side effects to Health Canada at||
0047|127|S|1-866-234-2345.||
0047|128|B|||
0047|129|P|PRECAUTIONS:  See also Warning section.||
0047|130|P|   Before taking doxepin, tell your doctor or pharmacist if you||
0047|131|P|are allergic to it; or to other tricyclic antidepressants (such||
0047|132|P|as nortriptyline); or if you have any other allergies. This||
0047|133|P|product may contain inactive ingredients, which can cause||
0047|134|P|allergic reactions or other problems. Talk to your pharmacist for||
0047|135|P|more details.||
0047|136|P|   Before using this medication, tell your doctor or pharmacist||
0047|137|P|your medical history, especially of: bleeding problems, breathing||
0047|138|P|problems, liver problems, recent heart attack, problems urinating||
0047|139|P|(such as due to enlarged prostate), overactive thyroid||
0047|140|P|(hyperthyroidism), personal or family history of glaucoma||
0047|141|P|(angle-closure type), personal or family history of mental/mood||
0047|142|P|conditions (such as bipolar disorder, psychosis), family history||
0047|143|P|of suicide, seizures, conditions that may increase your risk of||
0047|144|P|seizures (such as other brain disease, alcohol/sedative||
0047|145|P|withdrawal).||
0047|146|P|   Doxepin may cause a condition that affects the heart rhythm||
0047|147|P|(QT prolongation). QT prolongation can rarely cause serious||
0047|148|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0047|149|P|as severe dizziness, fainting) that need medical attention right||
0047|150|P|away.||
0047|151|P|   The risk of QT prolongation may be increased if you have||
0047|152|P|certain medical conditions or are taking other drugs that may||
0047|153|P|cause QT prolongation. Before using doxepin, tell your doctor or||
0047|154|P|pharmacist of all the drugs you take and if you have any of the||
0047|155|P|following conditions: certain heart problems (heart failure, slow||
0047|156|P|heartbeat, QT prolongation in the EKG), family history of certain||
0047|157|P|heart problems (QT prolongation in the EKG, sudden cardiac||
0047|158|P|death).||
0047|159|P|   Low levels of potassium or magnesium in the blood may also||
0047|160|P|increase your risk of QT prolongation. This risk may increase if||
0047|161|P|you use certain drugs (such as diuretics/"water pills") or if you||
0047|162|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0047|163|P|Talk to your doctor about using doxepin safely.||
0047|164|P|   This drug may make you dizzy or drowsy or blur your vision.||
0047|165|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0047|166|P|drowsy. Do not drive, use machinery, or do anything that needs||
0047|167|P|alertness or clear vision until you can do it safely. Limit||
0047|168|P|alcoholic beverages. Talk to your doctor if you are using||
0047|169|P|marijuana (cannabis).||
0047|170|P|   Before having surgery, tell your doctor or dentist about all||
0047|171|P|the products you use (including prescription drugs,||
0047|172|P|nonprescription drugs, and herbal products).||
0047|173|P|   This medication may make you more sensitive to the sun. Limit||
0047|174|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0047|175|P|sunscreen and wear protective clothing when outdoors. Tell your||
0047|176|P|doctor right away if you get sunburned or have skin||
0047|177|P|blisters/redness.||
0047|178|P|   If you have diabetes, this drug may make it harder to control||
0047|179|P|your blood sugar levels. Monitor your blood sugar levels||
0047|180|P|regularly and tell your doctor of the results. Your doctor may||
0047|181|P|need to adjust your diabetes medication, exercise program, or||
0047|182|P|diet.||
0047|183|P|   Older adults may be more sensitive to the side effects of this||
0047|184|P|drug, especially dry mouth, dizziness, drowsiness, confusion,||
0047|185|P|difficulty urinating and QT prolongation (see above).||
0047|186|P|   During pregnancy, this medication should be used only when||
0047|187|P|clearly needed. Babies born to mothers who have used this drug||
0047|188|P|during the last 3 months of pregnancy may rarely develop||
0047|189|P|withdrawal symptoms such as feeding/breathing difficulties,||
0047|190|P|seizures, muscle stiffness, or constant crying. If you notice any||
0047|191|P|of these symptoms in your newborn, tell the doctor promptly.||
0047|192|P|   Since untreated mental/mood problems (such as depression,||
0047|193|P|anxiety) can be a serious condition, do not stop using this||
0047|194|P|medication unless directed by your doctor. If you are planning||
0047|195|P|pregnancy, become pregnant, or think you may be pregnant,||
0047|196|P|immediately discuss with your doctor the benefits and risks of||
0047|197|P|using this medication during pregnancy.||
0047|198|P|   This medication passes into breast milk and may have||
0047|199|P|undesirable effects on a nursing infant. Breastfeeding is not||
0047|200|P|recommended while using this medication. Consult your doctor||
0047|201|P|before breastfeeding.||
0047|202|B|||
0047|203|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0047|204|I|medications work or increase your risk for serious side effects.||
0047|205|I|This document does not contain all possible drug interactions.||
0047|206|I|Keep a list of all the products you use (including||
0047|207|I|prescription/nonprescription drugs and herbal products) and share||
0047|208|I|it with your doctor and pharmacist. Do not start, stop, or change||
0047|209|I|the dosage of any medicines without your doctor's approval.||
0047|210|I|   Some products that may interact with this drug include:||
0047|211|I|thyroid supplements, central-acting drugs to treat high blood||
0047|212|I|pressure (such as clonidine, guanabenz).||
0047|213|I|   Taking MAO inhibitors with this medication may cause a serious||
0047|214|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0047|215|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0047|216|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0047|217|I|selegiline, tranylcypromine) during treatment with this||
0047|218|I|medication. Most MAO inhibitors should also not be taken for two||
0047|219|I|weeks before and after treatment with this medication. Ask your||
0047|220|I|doctor when to start or stop taking this medication.||
0047|221|I|   The risk of serotonin syndrome/toxicity increases if you are||
0047|222|I|also taking other drugs that increase serotonin. Examples include||
0047|223|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
0047|224|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0047|225|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0047|226|I|serotonin syndrome/toxicity may be more likely when you start or||
0047|227|I|increase the dose of these drugs.||
0047|228|I|   Other medications can affect the removal of doxepin from your||
0047|229|I|body, thereby affecting how doxepin works. These drugs include||
0047|230|I|cimetidine, drugs to treat irregular heart rate (such as||
0047|231|I|quinidine/propafenone/flecainide), among others.||
0047|232|I|   Many drugs besides doxepin may affect the heart rhythm (QT||
0047|233|I|prolongation in the EKG), including amiodarone, dofetilide,||
0047|234|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
0047|235|I|(such as erythromycin), among others. Before using doxepin,||
0047|236|I|report all medications you are currently using to your doctor or||
0047|237|I|pharmacist.||
0047|238|I|   Tell your doctor or pharmacist if you are taking other||
0047|239|I|products that cause drowsiness such as opioid pain or cough||
0047|240|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0047|241|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0047|242|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0047|243|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0047|244|I|diphenhydramine).||
0047|245|I|   Check the labels on all your medicines (such as allergy or||
0047|246|I|cough-and-cold products) because they may contain ingredients||
0047|247|I|that cause drowsiness. Ask your pharmacist about using those||
0047|248|I|products safely.||
0047|249|B|||
0047|250|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0047|251|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0047|252|O|poison control center right away. US residents can call||
0047|253|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0047|254|O|Symptoms of overdose may include: extreme drowsiness,||
0047|255|O|hallucinations, fast/irregular heartbeat, fainting, slow/shallow||
0047|256|O|breathing, seizures.||
0047|257|B|||
0047|258|N|NOTES:  Do not share this medication with others.||
0047|259|N|   Lab and/or medical tests (such as blood counts, blood||
0047|260|N|pressure, EKG, liver tests) may be done while you are taking this||
0047|261|N|medication. Keep all medical and lab appointments. Consult your||
0047|262|N|doctor for more details.||
0047|263|B|||
0047|264|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0047|265|D|remember. If it is near the time of the next dose, skip the||
0047|266|D|missed dose. Take your next dose at the regular time. Do not||
0047|267|D|double the dose to catch up.||
0047|268|B|||
0047|269|R|STORAGE:  Store at room temperature. Keep all medications away||
0047|270|R|from children and pets.||
0047|271|R|   Do not flush medications down the toilet or pour them into a||
0047|272|R|drain unless instructed to do so. Properly discard this product||
0047|273|R|when it is expired or no longer needed. Consult your pharmacist||
0047|274|R|or local waste disposal company.||
0047|275|B|||
0047|276|A|Information last revised July 2025.||
0047|277|A|Copyright(c) 2025 First Databank, Inc.||
0047|278|B|||
0048|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0048|002|Z|does NOT have all possible information about this product. This||
0048|003|Z|information does not assure that this product is safe, effective,||
0048|004|Z|or appropriate for you. This information is not individual||
0048|005|Z|medical advice and does not substitute for the advice of your||
0048|006|Z|health care professional. Always ask your health care||
0048|007|Z|professional for complete information about this product and your||
0048|008|Z|specific health needs.||
0048|009|B|||
0048|010|T|NITROGLYCERIN - SUBLINGUAL||
0048|011|F|(NYE-troe-GLIS-er-in)||
0048|012|B|||
0048|013|C|COMMON BRAND NAME(S): Nitrostat||
0048|014|B|||
0048|015|U|USES:  This medication is used to relieve chest pain (angina) in||
0048|016|U|people that have a certain heart condition (coronary artery||
0048|017|U|disease). It may also be used before physical activities (such as||
0048|018|U|exercise, sexual activity) to help prevent chest pain.||
0048|019|U|   Nitroglycerin belongs to a class of drugs known as nitrates.||
0048|020|U|Angina occurs when the heart muscle is not getting enough blood.||
0048|021|U|This drug works by relaxing and widening blood vessels so blood||
0048|022|U|can flow more easily to the heart.||
0048|023|B|||
0048|024|H|HOW TO USE:  Ask your doctor now for exact instructions on how to||
0048|025|H|use your nitroglycerin and when to call for emergency medical||
0048|026|H|help (911).||
0048|027|H|   Read the Patient Information Leaflet if available from your||
0048|028|H|pharmacist before you start using nitroglycerin and each time you||
0048|029|H|get a refill. If you have any questions, ask your doctor or||
0048|030|H|pharmacist.||
0048|031|H|   Sit down before using this medication. Place 1 tablet under||
0048|032|H|the tongue and allow it to dissolve as directed by your doctor.||
0048|033|H|Do not chew or swallow the tablet. The dosage is based on your||
0048|034|H|medical condition and response to treatment.||
0048|035|H|   If you are using this medication to prevent chest pain before||
0048|036|H|physical activities, use it 5 to 10 minutes before the activity.||
0048|037|H|   If you are using this medication to relieve chest pain once it||
0048|038|H|occurs, use it as soon as possible. If your chest pain has not||
0048|039|H|improved or if it has worsened 5 minutes after you use this drug,||
0048|040|H|call emergency medical help (911). After calling the emergency||
0048|041|H|number, use another dose. Five minutes after the second dose, if||
0048|042|H|you still have chest pain and the ambulance has not arrived, use||
0048|043|H|a third dose. If your chest pain is not gone after 15 minutes and||
0048|044|H|3 doses of nitroglycerin, call emergency medical help (911) if||
0048|045|H|you have not called already. Do not use more than 3 doses during||
0048|046|H|an attack unless directed by your doctor.||
0048|047|B|||
0048|048|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, nausea,||
0048|049|S|flushing, and burning/tingling under the tongue may occur. If any||
0048|050|S|of these effects last or get worse, tell your doctor or||
0048|051|S|pharmacist promptly.||
0048|052|S|   Headache is often a sign that this medication is working. Your||
0048|053|S|doctor may recommend treating headaches with an over-the-counter||
0048|054|S|pain reliever (such as acetaminophen, aspirin). If the headaches||
0048|055|S|continue or become severe, tell your doctor promptly.||
0048|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
0048|057|S|slowly when rising from a sitting or lying position.||
0048|058|S|   Remember that this medication has been prescribed because your||
0048|059|S|doctor has judged that the benefit to you is greater than the||
0048|060|S|risk of side effects. Many people using this medication do not||
0048|061|S|have serious side effects.||
0048|062|S|   Tell your doctor right away if you have any serious side||
0048|063|S|effects, including: fainting, fast/irregular/pounding heartbeat.||
0048|064|S|   A very serious allergic reaction to this drug is rare.||
0048|065|S|However, get medical help right away if you notice any symptoms||
0048|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0048|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0048|068|S|breathing.||
0048|069|S|   This is not a complete list of possible side effects. If you||
0048|070|S|notice other effects not listed above, contact your doctor or||
0048|071|S|pharmacist.||
0048|072|S|   In the US -||
0048|073|S|   Call your doctor for medical advice about side effects. You||
0048|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0048|075|S|www.fda.gov/medwatch.||
0048|076|S|   In Canada - Call your doctor for medical advice about side||
0048|077|S|effects. You may report side effects to Health Canada at||
0048|078|S|1-866-234-2345.||
0048|079|B|||
0048|080|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0048|081|P|pharmacist if you are allergic to it; or to similar drugs (such||
0048|082|P|as isosorbide mononitrate); or to nitrites; or if you have any||
0048|083|P|other allergies. This product may contain inactive ingredients,||
0048|084|P|which can cause allergic reactions or other problems. Talk to||
0048|085|P|your pharmacist for more details.||
0048|086|P|   Before using this medication, tell your doctor or pharmacist||
0048|087|P|your medical history, especially of: recent head injury, anemia,||
0048|088|P|low blood pressure, dehydration, other heart problems (such as||
0048|089|P|recent heart attack).||
0048|090|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0048|091|P|can make you more dizzy. Do not drive, use machinery, or do||
0048|092|P|anything that needs alertness until you can do it safely. Limit||
0048|093|P|alcoholic beverages. Talk to your doctor if you are using||
0048|094|P|marijuana (cannabis).||
0048|095|P|   Before having surgery, tell your doctor or dentist about all||
0048|096|P|the products you use (including prescription drugs,||
0048|097|P|nonprescription drugs, and herbal products).||
0048|098|P|   Older adults may be more sensitive to the side effects of this||
0048|099|P|medication, especially dizziness and lightheadedness which could||
0048|100|P|increase the risk of falls.||
0048|101|P|   During pregnancy, this medication should be used only when||
0048|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0048|103|P|   It is unknown if this medication passes into breast milk or if||
0048|104|P|it may harm a nursing infant. Consult your doctor before||
0048|105|P|breastfeeding.||
0048|106|B|||
0048|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0048|108|I|medications work or increase your risk for serious side effects.||
0048|109|I|This document does not contain all possible drug interactions.||
0048|110|I|Keep a list of all the products you use (including||
0048|111|I|prescription/nonprescription drugs and herbal products) and share||
0048|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
0048|113|I|the dosage of any medicines without your doctor's approval.||
0048|114|I|   Some products that may interact with this drug include: drugs||
0048|115|I|used to treat erectile dysfunction-ED or pulmonary hypertension||
0048|116|I|(such as sildenafil, tadalafil), certain drugs to treat migraine||
0048|117|I|headaches (ergot alkaloids such as ergotamine), riociguat,||
0048|118|I|vericiguat.||
0048|119|I|   This medication may interfere with certain lab tests (such as||
0048|120|I|blood cholesterol levels), possibly causing false test results.||
0048|121|I|Make sure lab personnel and all your doctors know you use this||
0048|122|I|drug.||
0048|123|B|||
0048|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0048|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0048|126|O|poison control center right away. US residents can call||
0048|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0048|128|O|Symptoms of overdose may include: slow heartbeat, vision changes,||
0048|129|O|severe nausea/vomiting, sweating, cold/clammy skin, bluish||
0048|130|O|fingers/toes/lips.||
0048|131|B|||
0048|132|N|NOTES:  Do not share this medication with others.||
0048|133|B|||
0048|134|D|MISSED DOSE:  Not applicable.||
0048|135|B|||
0048|136|R|STORAGE:  Store in the original glass bottle at room temperature||
0048|137|R|away from light, heat, and moisture. Do not store in the||
0048|138|R|bathroom. Tightly close the bottle when not in use. Keep all||
0048|139|R|medications away from children and pets.||
0048|140|R|   Do not flush medications down the toilet or pour them into a||
0048|141|R|drain unless instructed to do so. Properly discard this product||
0048|142|R|when it is expired or no longer needed. Consult your pharmacist||
0048|143|R|or local waste disposal company.||
0048|144|B|||
0048|145|M|MEDICAL ALERT:  Your condition can cause complications in a||
0048|146|M|medical emergency. For information about enrolling in MedicAlert,||
0048|147|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0048|148|B|||
0048|149|A|Information last revised July 2024.||
0048|150|A|Copyright(c) 2025 First Databank, Inc.||
0048|151|B|||
0055|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0055|002|Z|does NOT have all possible information about this product. This||
0055|003|Z|information does not assure that this product is safe, effective,||
0055|004|Z|or appropriate for you. This information is not individual||
0055|005|Z|medical advice and does not substitute for the advice of your||
0055|006|Z|health care professional. Always ask your health care||
0055|007|Z|professional for complete information about this product and your||
0055|008|Z|specific health needs.||
0055|009|B|||
0055|010|T|METRONIDAZOLE - ORAL||
0055|011|F|(MET-roe-NID-a-zole)||
0055|012|B|||
0055|013|C|COMMON BRAND NAME(S): Flagyl, Likmez||
0055|014|B|||
0055|015|U|USES:  Metronidazole is an antibiotic that is used to treat a||
0055|016|U|wide variety of infections. It works by stopping the growth of||
0055|017|U|certain bacteria and parasites.||
0055|018|U|   This antibiotic treats only certain bacterial and parasitic||
0055|019|U|infections. It will not work for viral infections (such as common||
0055|020|U|cold, flu). Using any antibiotic when it is not needed can cause||
0055|021|U|it to not work for future infections.||
0055|022|U|   Metronidazole may also be used with other medications to treat||
0055|023|U|certain stomach/intestinal ulcers caused by a bacteria (H.||
0055|024|U|pylori).||
0055|025|B|||
0055|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0055|027|H|from your pharmacist before you start taking metronidazole and||
0055|028|H|each time you get a refill. If you have any questions, ask your||
0055|029|H|doctor or pharmacist.||
0055|030|H|   Take this medication by mouth as directed by your doctor. To||
0055|031|H|prevent stomach upset, take this medication with food or a full||
0055|032|H|glass of water or milk.||
0055|033|H|   If you are using the suspension form of this medication, shake||
0055|034|H|the bottle well before each dose. Carefully measure the dose||
0055|035|H|using a special measuring device/spoon. Do not use a household||
0055|036|H|spoon because you may not get the correct dose.||
0055|037|H|   The dosage is based on your medical condition and response to||
0055|038|H|treatment. Children's dosage is also based on weight.||
0055|039|H|   For the best effect, take this antibiotic at evenly spaced||
0055|040|H|times. To help you remember, take this medication at the same||
0055|041|H|time(s) every day.||
0055|042|H|   Continue to take this medication until the full prescribed||
0055|043|H|amount is finished, even if symptoms disappear after a few days.||
0055|044|H|Stopping the medication too early may result in a return of the||
0055|045|H|infection.||
0055|046|H|   Tell your doctor if your condition lasts or gets worse.||
0055|047|B|||
0055|048|S|SIDE EFFECTS:  Dizziness, headache, stomach upset, nausea,||
0055|049|S|vomiting, loss of appetite, diarrhea, constipation, or metallic||
0055|050|S|taste in your mouth may occur. If any of these effects last or||
0055|051|S|get worse, tell your doctor or pharmacist promptly.||
0055|052|S|   This medication may cause your urine to turn darker in color.||
0055|053|S|This effect is harmless and will disappear when the medication is||
0055|054|S|stopped.||
0055|055|S|   Remember that this medication has been prescribed because your||
0055|056|S|doctor has judged that the benefit to you is greater than the||
0055|057|S|risk of side effects. Many people using this medication do not||
0055|058|S|have serious side effects.||
0055|059|S|   Tell your doctor right away if you have any serious side||
0055|060|S|effects, including: easy bruising/bleeding, stomach/abdominal||
0055|061|S|pain, painful urination.||
0055|062|S|   Get medical help right away if you have any very serious side||
0055|063|S|effects, including: unsteadiness, seizures, mental/mood changes||
0055|064|S|(such as confusion), trouble speaking, numbness/tingling of||
0055|065|S|arms/legs, eye pain, sudden vision changes, headache that is||
0055|066|S|severe or doesn't go away, stiff/painful neck.||
0055|067|S|   Use of this medication for prolonged or repeated periods may||
0055|068|S|result in oral thrush or a new yeast infection. Contact your||
0055|069|S|doctor if you notice white patches in your mouth, a change in||
0055|070|S|vaginal discharge, or other new symptoms.||
0055|071|S|   A very serious allergic reaction to this drug is rare.||
0055|072|S|However, get medical help right away if you notice any symptoms||
0055|073|S|of a serious allergic reaction, including: fever that doesn't go||
0055|074|S|away, new or worsening lymph node swelling, rash,||
0055|075|S|itching/swelling (especially of the face/tongue/throat), severe||
0055|076|S|dizziness, trouble breathing.||
0055|077|S|   This is not a complete list of possible side effects. If you||
0055|078|S|notice other effects not listed above, contact your doctor or||
0055|079|S|pharmacist.||
0055|080|S|   In the US -||
0055|081|S|   Call your doctor for medical advice about side effects. You||
0055|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0055|083|S|www.fda.gov/medwatch.||
0055|084|S|   In Canada - Call your doctor for medical advice about side||
0055|085|S|effects. You may report side effects to Health Canada at||
0055|086|S|1-866-234-2345.||
0055|087|B|||
0055|088|P|PRECAUTIONS:  Before taking metronidazole, tell your doctor or||
0055|089|P|pharmacist if you are allergic to it; or to other antibiotics||
0055|090|P|(such as tinidazole); or if you have any other allergies. This||
0055|091|P|product may contain inactive ingredients, which can cause||
0055|092|P|allergic reactions or other problems. Talk to your pharmacist for||
0055|093|P|more details.||
0055|094|P|   Before using this medication, tell your doctor or pharmacist||
0055|095|P|your medical history, especially of: liver disease, kidney||
0055|096|P|disease, certain blood disorders (low blood cell counts), a||
0055|097|P|certain rare genetic disorder (Cockayne syndrome).||
0055|098|P|   Avoid alcoholic beverages and products containing propylene||
0055|099|P|glycol while taking this medication and for at least 3 days after||
0055|100|P|finishing this medicine because severe stomach upset/cramps,||
0055|101|P|nausea, vomiting, headache, and flushing may occur.||
0055|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0055|103|P|can make you more dizzy. Do not drive, use machinery, or do||
0055|104|P|anything that needs alertness until you can do it safely. Talk to||
0055|105|P|your doctor if you are using marijuana (cannabis).||
0055|106|P|   Metronidazole may cause live bacterial vaccines (such as||
0055|107|P|typhoid vaccine) to not work well. Tell your health care||
0055|108|P|professional that you are using metronidazole before having any||
0055|109|P|immunizations/vaccinations.||
0055|110|P|   Before having surgery, tell your doctor or dentist about all||
0055|111|P|the products you use (including prescription drugs,||
0055|112|P|nonprescription drugs, and herbal products).||
0055|113|P|   During pregnancy, this medication should be used only when||
0055|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
0055|115|P|   This medication passes into breast milk. If you are prescribed||
0055|116|P|the single-dose treatment, your doctor may direct you to stop||
0055|117|P|breastfeeding for a short time after the dose. Consult your||
0055|118|P|doctor before breastfeeding.||
0055|119|B|||
0055|120|I|DRUG INTERACTIONS:  See also Precautions section.||
0055|121|I|   Drug interactions may change how your medications work or||
0055|122|I|increase your risk for serious side effects. This document does||
0055|123|I|not contain all possible drug interactions. Keep a list of all||
0055|124|I|the products you use (including prescription/nonprescription||
0055|125|I|drugs and herbal products) and share it with your doctor and||
0055|126|I|pharmacist. Do not start, stop, or change the dosage of any||
0055|127|I|medicines without your doctor's approval.||
0055|128|I|   Some products that may interact with this drug include:||
0055|129|I|alcohol-containing products (such as cough and cold syrups,||
0055|130|I|aftershave), products containing propylene glycol,||
0055|131|I|lopinavir/ritonavir solution, lithium.||
0055|132|I|   Do not take metronidazole if you are also taking disulfiram or||
0055|133|I|if you have taken disulfiram within the last 2 weeks.||
0055|134|I|   This medication may interfere with certain lab tests, possibly||
0055|135|I|causing false test results. Make sure lab personnel and all your||
0055|136|I|doctors know you use this drug.||
0055|137|B|||
0055|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0055|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0055|140|O|poison control center right away. US residents can call||
0055|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0055|142|O|Symptoms of overdose may include: nausea, vomiting, unsteadiness.||
0055|143|B|||
0055|144|N|NOTES:  Do not share this medication with others.||
0055|145|N|   If you are being treated for a certain infection||
0055|146|N|(trichomoniasis), all sexual partners may also need to be treated||
0055|147|N|to avoid re-infection. During treatment, avoid sexual||
0055|148|N|intercourse, or always use a latex or polyurethane condom.||
0055|149|N|   This medication has been prescribed for your current condition||
0055|150|N|only. Do not use it later for another infection unless your||
0055|151|N|doctor tells you to.||
0055|152|N|   If you are taking this medication for a longer time, lab tests||
0055|153|N|(such as blood cell counts) may be done while you are taking this||
0055|154|N|medication. Keep all medical and lab appointments. Consult your||
0055|155|N|doctor for more details.||
0055|156|B|||
0055|157|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0055|158|D|remember. If it is near the time of the next dose, skip the||
0055|159|D|missed dose. Take your next dose at the regular time. Do not||
0055|160|D|double the dose to catch up.||
0055|161|B|||
0055|162|R|STORAGE:  Store at room temperature away from light and moisture.||
0055|163|R|Do not store in the bathroom. Do not freeze the suspension form||
0055|164|R|of this medication. Once the bottle for the suspension is opened,||
0055|165|R|the medication expires after 60 days. Keep all medications away||
0055|166|R|from children and pets.||
0055|167|R|   Do not flush medications down the toilet or pour them into a||
0055|168|R|drain unless instructed to do so. Properly discard this product||
0055|169|R|when it is expired or no longer needed. Consult your pharmacist||
0055|170|R|or local waste disposal company.||
0055|171|B|||
0055|172|A|Information last revised September 2024.||
0055|173|A|Copyright(c) 2025 First Databank, Inc.||
0055|174|B|||
0056|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0056|002|Z|does NOT have all possible information about this product. This||
0056|003|Z|information does not assure that this product is safe, effective,||
0056|004|Z|or appropriate for you. This information is not individual||
0056|005|Z|medical advice and does not substitute for the advice of your||
0056|006|Z|health care professional. Always ask your health care||
0056|007|Z|professional for complete information about this product and your||
0056|008|Z|specific health needs.||
0056|009|B|||
0056|010|T|METHYLDOPA - ORAL||
0056|011|F|(METH-il-DOE-pa)||
0056|012|B|||
0056|013|C|COMMON BRAND NAME(S): Aldomet||
0056|014|B|||
0056|015|U|USES:  This medication is used alone or with other medications to||
0056|016|U|treat high blood pressure (hypertension). Lowering high blood||
0056|017|U|pressure helps prevent strokes, heart attacks, and kidney||
0056|018|U|problems. Methyldopa works by relaxing blood vessels so blood can||
0056|019|U|flow more easily.||
0056|020|B|||
0056|021|H|HOW TO USE:  Take this medication by mouth with or without food||
0056|022|H|as directed by your doctor, usually 2 to 4 times daily. Start||
0056|023|H|this medication or any new dose increase in the evening to||
0056|024|H|decrease the risk of side effects. Also, if the doses of this||
0056|025|H|medication are not equal, take the larger dose at bedtime.||
0056|026|H|   The dosage is based on your medical condition and response to||
0056|027|H|treatment.||
0056|028|H|   Use this medication regularly to get the most benefit from it.||
0056|029|H|To help you remember, take it at the same times each day. Keep||
0056|030|H|taking this medication even if you feel well. Most people with||
0056|031|H|high blood pressure do not feel sick.||
0056|032|H|   When used for a long time, this medication may not work as||
0056|033|H|well and may require different dosing or an additional||
0056|034|H|medication. Tell your doctor if your condition does not get||
0056|035|H|better or if it gets worse (your blood pressure readings remain||
0056|036|H|high or increase).||
0056|037|B|||
0056|038|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, headache,||
0056|039|S|stuffy nose, and weakness may occur as your body adjusts to the||
0056|040|S|medication. If any of these effects last or get worse, tell your||
0056|041|S|doctor or pharmacist promptly.||
0056|042|S|   To reduce the risk of dizziness and lightheadedness, get up||
0056|043|S|slowly when rising from a sitting or lying position.||
0056|044|S|   Remember that this medication has been prescribed because your||
0056|045|S|doctor has judged that the benefit to you is greater than the||
0056|046|S|risk of side effects. Many people using this medication do not||
0056|047|S|have serious side effects.||
0056|048|S|   Tell your doctor right away if you have any serious side||
0056|049|S|effects, including: fainting, muscle spasms/uncontrolled muscle||
0056|050|S|movements, missed/stopped periods, decreased sexual||
0056|051|S|desire/ability, increased breast size (in men), mental/mood||
0056|052|S|changes (such as depression), symptoms of heart failure (such as||
0056|053|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
0056|054|S|unusual/sudden weight gain).||
0056|055|S|   Methyldopa has rarely caused very serious (rarely fatal) liver||
0056|056|S|disease or low red blood cell count (anemia). Tell your doctor||
0056|057|S|right away if you develop any symptoms of liver disease or||
0056|058|S|anemia, including: nausea/vomiting that doesn't stop, unusual||
0056|059|S|tiredness, fast heartbeat, unexplained fever, dark urine, severe||
0056|060|S|stomach/abdominal pain, yellowing eyes/skin.||
0056|061|S|   A very serious allergic reaction to this drug is rare.||
0056|062|S|However, get medical help right away if you notice any symptoms||
0056|063|S|of a serious allergic reaction, including: rash, itching/swelling||
0056|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0056|065|S|breathing.||
0056|066|S|   This is not a complete list of possible side effects. If you||
0056|067|S|notice other effects not listed above, contact your doctor or||
0056|068|S|pharmacist.||
0056|069|S|   In the US -||
0056|070|S|   Call your doctor for medical advice about side effects. You||
0056|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0056|072|S|www.fda.gov/medwatch.||
0056|073|S|   In Canada - Call your doctor for medical advice about side||
0056|074|S|effects. You may report side effects to Health Canada at||
0056|075|S|1-866-234-2345.||
0056|076|B|||
0056|077|P|PRECAUTIONS:  Before taking methyldopa, tell your doctor or||
0056|078|P|pharmacist if you are allergic to it; or if you have any other||
0056|079|P|allergies. This product may contain inactive ingredients, which||
0056|080|P|can cause allergic reactions or other problems. Talk to your||
0056|081|P|pharmacist for more details.||
0056|082|P|   Before using this medication, tell your doctor or pharmacist||
0056|083|P|your medical history, especially of: liver disease (such as||
0056|084|P|hepatitis, cirrhosis), low red blood cell count (anemia), heart||
0056|085|P|failure, a certain adrenal gland tumor (pheochromocytoma), a||
0056|086|P|certain genetic condition (glucose-6-phosphate dehydrogenase||
0056|087|P|deficiency).||
0056|088|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0056|089|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0056|090|P|machinery, or do anything that needs alertness until you can do||
0056|091|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0056|092|P|are using marijuana (cannabis).||
0056|093|P|   Before having surgery, tell your doctor or dentist about all||
0056|094|P|the products you use (including prescription drugs,||
0056|095|P|nonprescription drugs, and herbal products).||
0056|096|P|   Older adults may be more sensitive to the side effects of this||
0056|097|P|medication, especially dizziness (more likely when standing up),||
0056|098|P|fainting, or depression. Dizziness and fainting can increase the||
0056|099|P|risk of falling.||
0056|100|P|   Tell your doctor if you are pregnant before using this||
0056|101|P|medication.||
0056|102|P|   This medication passes into breast milk but is unlikely to||
0056|103|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0056|104|B|||
0056|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0056|106|I|medications work or increase your risk for serious side effects.||
0056|107|I|This document does not contain all possible drug interactions.||
0056|108|I|Keep a list of all the products you use (including||
0056|109|I|prescription/nonprescription drugs and herbal products) and share||
0056|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0056|111|I|the dosage of any medicines without your doctor's approval.||
0056|112|I|   Some products that may interact with this drug include: iron||
0056|113|I|products (such as ferrous sulfate, ferrous gluconate), lithium.||
0056|114|I|   Taking MAO inhibitors with this medication may cause a serious||
0056|115|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0056|116|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0056|117|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0056|118|I|selegiline, tranylcypromine) during treatment with this||
0056|119|I|medication. Most MAO inhibitors should also not be taken for two||
0056|120|I|weeks before treatment with this medication. Ask your doctor when||
0056|121|I|to start or stop taking this medication.||
0056|122|I|   Tell your doctor or pharmacist if you are taking other||
0056|123|I|products that cause drowsiness including alcohol, marijuana||
0056|124|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0056|125|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0056|126|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0056|127|I|codeine).||
0056|128|I|   Check the labels on all your medicines (such as allergy or||
0056|129|I|cough-and-cold products) because they may contain ingredients||
0056|130|I|that cause drowsiness. Ask your pharmacist about using those||
0056|131|I|products safely.||
0056|132|I|   Some products have ingredients that could raise your blood||
0056|133|I|pressure. Tell your pharmacist what products you are using, and||
0056|134|I|ask how to use them safely (especially cough-and-cold products,||
0056|135|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0056|136|I|   This medication may interfere with certain lab tests (such as||
0056|137|I|urine catecholamine test), possibly causing false test results.||
0056|138|I|Make sure lab personnel and all your doctors know you use this||
0056|139|I|drug.||
0056|140|B|||
0056|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0056|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0056|143|O|poison control center right away. US residents can call||
0056|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0056|145|O|Symptoms of overdose may include: severe drowsiness/dizziness.||
0056|146|B|||
0056|147|N|NOTES:  Do not share this medication with others.||
0056|148|N|   Lab and/or medical tests (such as hematocrit/hemoglobin,||
0056|149|N|complete blood count, Coombs test, liver function) should be done||
0056|150|N|while you are taking this medication. Keep all medical and lab||
0056|151|N|appointments. Consult your doctor for more details.||
0056|152|N|   Lifestyle changes such as stress reduction programs, exercise,||
0056|153|N|and dietary changes may increase the effectiveness of this||
0056|154|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0056|155|N|changes that might benefit you.||
0056|156|N|   Check your blood pressure regularly while taking this||
0056|157|N|medication. Learn how to monitor your own blood pressure at home,||
0056|158|N|and share the results with your doctor.||
0056|159|B|||
0056|160|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0056|161|D|remember. If it is near the time of the next dose, skip the||
0056|162|D|missed dose. Take your next dose at the regular time. Do not||
0056|163|D|double the dose to catch up.||
0056|164|B|||
0056|165|R|STORAGE:  Store at room temperature away from light and moisture.||
0056|166|R|Do not store in the bathroom. Keep all medications away from||
0056|167|R|children and pets.||
0056|168|R|   Do not flush medications down the toilet or pour them into a||
0056|169|R|drain unless instructed to do so. Properly discard this product||
0056|170|R|when it is expired or no longer needed. Consult your pharmacist||
0056|171|R|or local waste disposal company.||
0056|172|B|||
0056|173|A|Information last revised August 2024.||
0056|174|A|Copyright(c) 2025 First Databank, Inc.||
0056|175|B|||
0057|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0057|002|Z|does NOT have all possible information about this product. This||
0057|003|Z|information does not assure that this product is safe, effective,||
0057|004|Z|or appropriate for you. This information is not individual||
0057|005|Z|medical advice and does not substitute for the advice of your||
0057|006|Z|health care professional. Always ask your health care||
0057|007|Z|professional for complete information about this product and your||
0057|008|Z|specific health needs.||
0057|009|B|||
0057|010|T|PHENYTOIN EXTENDED CAPSULE - ORAL||
0057|011|F|(FEN-i-toyn)||
0057|012|B|||
0057|013|C|COMMON BRAND NAME(S): Dilantin||
0057|014|B|||
0057|015|U|USES:  Phenytoin is used to prevent and control seizures (also||
0057|016|U|called an anticonvulsant or antiepileptic drug). It works by||
0057|017|U|reducing the spread of seizure activity in the brain.||
0057|018|B|||
0057|019|V|OTHER USES:  This section contains uses of this drug that are not||
0057|020|V|listed in the approved professional labeling for the drug but||
0057|021|V|that may be prescribed by your health care professional. Use this||
0057|022|V|drug for a condition that is listed in this section only if it||
0057|023|V|has been so prescribed by your health care professional.||
0057|024|V|   This drug may also be used for certain types of irregular||
0057|025|V|heartbeats.||
0057|026|B|||
0057|027|H|HOW TO USE:  Read the Medication Guide provided by your||
0057|028|H|pharmacist before you start taking phenytoin and each time you||
0057|029|H|get a refill. If you have any questions, ask your doctor or||
0057|030|H|pharmacist.||
0057|031|H|   Take this medication by mouth as directed by your doctor,||
0057|032|H|usually once a day or in divided doses. You may take it with food||
0057|033|H|if stomach upset occurs. Take this medication with a full glass||
0057|034|H|(8 ounces or 240 milliliters) of water unless your doctor directs||
0057|035|H|you otherwise.||
0057|036|H|   Swallow the capsules whole. Do not use the capsules if||
0057|037|H|discolored.||
0057|038|H|   Use this medication regularly in order to get the most benefit||
0057|039|H|from it. It is important to take all doses on time to keep the||
0057|040|H|amount of medicine in your body at a constant level. Remember to||
0057|041|H|use it at the same time(s) each day. The dosage is based on your||
0057|042|H|medical condition, lab tests, and response to treatment.||
0057|043|H|Children's dosage is also based on weight.||
0057|044|H|   Antacids and nutritional tube-feeding (enteral) products may||
0057|045|H|decrease the absorption of phenytoin. Do not take these products||
0057|046|H|at the same time as your phenytoin dose. Separate liquid||
0057|047|H|nutritional products at least 1 hour before and 1 hour after your||
0057|048|H|phenytoin dose, or as directed by your doctor.||
0057|049|H|   Do not stop taking this medication without consulting your||
0057|050|H|doctor. Seizures may become worse when the drug is suddenly||
0057|051|H|stopped. Your dose may need to be gradually decreased.||
0057|052|H|   Tell your doctor if your condition does not get better or if||
0057|053|H|it gets worse.||
0057|054|B|||
0057|055|S|SIDE EFFECTS:  Headache, nausea, vomiting, constipation,||
0057|056|S|dizziness, feeling of spinning, drowsiness, trouble sleeping, or||
0057|057|S|nervousness may occur. If any of these effects last or get worse,||
0057|058|S|tell your doctor or pharmacist promptly.||
0057|059|S|   Phenytoin may cause swelling and bleeding of the gums. Massage||
0057|060|S|your gums and brush and floss your teeth regularly to minimize||
0057|061|S|this problem. See your dentist regularly.||
0057|062|S|   Remember that this medication has been prescribed because your||
0057|063|S|doctor has judged that the benefit to you is greater than the||
0057|064|S|risk of side effects. Many people using this medication do not||
0057|065|S|have serious side effects.||
0057|066|S|   Tell your doctor right away if you have any serious side||
0057|067|S|effects, including: slow heartbeat, unusual eye movements, loss||
0057|068|S|of coordination, trouble speaking, confusion, muscle twitching,||
0057|069|S|double/blurred vision, tingling of the hands/feet, facial changes||
0057|070|S|(such as swollen lips, butterfly-shaped rash around the||
0057|071|S|nose/cheeks), excessive hair growth, increased thirst/urination,||
0057|072|S|unusual tiredness, bone/joint pain, easily broken bones.||
0057|073|S|   A small number of people who take anticonvulsants for any||
0057|074|S|condition (such as seizure, bipolar disorder, pain) may||
0057|075|S|experience depression, suicidal thoughts/attempts, or other||
0057|076|S|mental/mood problems. Tell your doctor right away if you or your||
0057|077|S|family/caregiver notice any unusual/sudden changes in your mood,||
0057|078|S|thoughts, or behavior including signs of depression, suicidal||
0057|079|S|thoughts/attempts, thoughts about harming yourself.||
0057|080|S|   Rarely, males may have a painful or prolonged erection lasting||
0057|081|S|4 or more hours. If this occurs, stop using this drug and get||
0057|082|S|medical help right away, or permanent problems could occur.||
0057|083|S|   Get medical help right away if you have any very serious side||
0057|084|S|effects, including: uncontrolled muscle movements, signs of liver||
0057|085|S|problems (such as nausea/vomiting that doesn't stop,||
0057|086|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
0057|087|S|bruising/bleeding.||
0057|088|S|   A very serious allergic reaction to this drug is rare.||
0057|089|S|However, get medical help right away if you notice any symptoms||
0057|090|S|of a serious allergic reaction, including: fever, swollen lymph||
0057|091|S|nodes, rash, itching/swelling (especially of the||
0057|092|S|face/tongue/throat), severe dizziness, trouble breathing.||
0057|093|S|   This is not a complete list of possible side effects. If you||
0057|094|S|notice other effects not listed above, contact your doctor or||
0057|095|S|pharmacist.||
0057|096|S|   In the US -||
0057|097|S|   Call your doctor for medical advice about side effects. You||
0057|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0057|099|S|www.fda.gov/medwatch.||
0057|100|S|   In Canada - Call your doctor for medical advice about side||
0057|101|S|effects. You may report side effects to Health Canada at||
0057|102|S|1-866-234-2345.||
0057|103|B|||
0057|104|P|PRECAUTIONS:  Before taking phenytoin, tell your doctor or||
0057|105|P|pharmacist if you are allergic to it; or to other anti-seizure||
0057|106|P|medications (such as carbamazepine, ethosuximide, ethotoin,||
0057|107|P|fosphenytoin, oxcarbazepine, phenobarbital, primidone,||
0057|108|P|trimethadione); or if you have any other allergies. This product||
0057|109|P|may contain inactive ingredients, which can cause allergic||
0057|110|P|reactions or other problems. Talk to your pharmacist for more||
0057|111|P|details.||
0057|112|P|   Before using this medication, tell your doctor or pharmacist||
0057|113|P|your medical history, especially of: alcohol use, certain blood||
0057|114|P|conditions (porphyria), diabetes, liver disease (including liver||
0057|115|P|disease caused by past phenytoin use), lupus, folate or vitamin||
0057|116|P|B-12 deficiency (megaloblastic anemia).||
0057|117|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0057|118|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0057|119|P|machinery, or do anything that needs alertness until you can do||
0057|120|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0057|121|P|are using marijuana (cannabis). Alcohol may also affect your||
0057|122|P|blood levels of this drug.||
0057|123|P|   Before having surgery, tell your doctor or dentist about all||
0057|124|P|the products you use (including prescription drugs,||
0057|125|P|nonprescription drugs, and herbal products).||
0057|126|P|   If you have diabetes, this product may make it harder to||
0057|127|P|control your blood sugar. Check your blood sugar regularly as||
0057|128|P|directed and share the results with your doctor. Your doctor may||
0057|129|P|need to adjust your diabetes medication, exercise program, or||
0057|130|P|diet.||
0057|131|P|   Vitamin D supplements may be necessary to prevent weakening of||
0057|132|P|the bones (osteomalacia). Discuss this with your doctor.||
0057|133|P|   During pregnancy, this medication should be used only when||
0057|134|P|clearly needed. It may harm an unborn baby. However, since||
0057|135|P|untreated seizures are a serious condition that can harm both a||
0057|136|P|pregnant woman and her unborn baby, do not stop taking this||
0057|137|P|medication unless directed by your doctor. If you are planning||
0057|138|P|pregnancy, become pregnant, or think you may be pregnant,||
0057|139|P|immediately talk to your doctor about the benefits and risks of||
0057|140|P|using this medication during pregnancy. Since birth control||
0057|141|P|pills, patches, implants, and injections may not work if taken||
0057|142|P|with this medication (see also Drug Interactions section),||
0057|143|P|discuss reliable forms of birth control with your doctor.||
0057|144|P|   Phenytoin passes into breast milk. Consult your doctor before||
0057|145|P|breastfeeding.||
0057|146|B|||
0057|147|I|DRUG INTERACTIONS:  See also How to Use section.||
0057|148|I|   Drug interactions may change how your medications work or||
0057|149|I|increase your risk for serious side effects. This document does||
0057|150|I|not contain all possible drug interactions. Keep a list of all||
0057|151|I|the products you use (including prescription/nonprescription||
0057|152|I|drugs and herbal products) and share it with your doctor and||
0057|153|I|pharmacist. Do not start, stop, or change the dosage of any||
0057|154|I|medicines without your doctor's approval.||
0057|155|I|   Some products that may interact with this drug include:||
0057|156|I|colesevelam, orlistat, sucralfate.||
0057|157|I|   Other medications can affect the removal of phenytoin from||
0057|158|I|your body, which may affect how phenytoin works. Examples include||
0057|159|I|amiodarone, azapropazone, azole antifungals (such as||
0057|160|I|itraconazole), macrolide antibiotics (such as erythromycin),||
0057|161|I|estrogens, isoniazid, rifamycins (such as rifabutin), St. John's||
0057|162|I|wort, among others.||
0057|163|I|   Phenytoin can speed up the removal of other medications from||
0057|164|I|your body, which may affect how they work. Examples of affected||
0057|165|I|drugs include atazanavir, some drugs to treat cancer (such as||
0057|166|I|imatinib, irinotecan), cobicistat, corticosteroids (such as||
0057|167|I|prednisone), doravirine, etravirine, felodipine, nisoldipine,||
0057|168|I|rilpivirine, quetiapine, quinidine, suvorexant, telithromycin,||
0057|169|I|theophylline, vitamin D, among others.||
0057|170|I|   This medication may decrease the effectiveness of hormonal||
0057|171|I|birth control such as pills, patch, or ring. This could cause||
0057|172|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0057|173|I|use reliable backup birth control methods while using this||
0057|174|I|medication. Also tell your doctor if you have any new spotting or||
0057|175|I|breakthrough bleeding, because these may be signs that your birth||
0057|176|I|control is not working well.||
0057|177|I|   This medication may interfere with certain lab tests, possibly||
0057|178|I|causing false test results. Make sure lab personnel and all your||
0057|179|I|doctors know you use this drug.||
0057|180|B|||
0057|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0057|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0057|183|O|poison control center right away. US residents can call||
0057|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0057|185|O|Symptoms of overdose may include: severe mental/mood changes,||
0057|186|O|severe drowsiness, loss of consciousness, slowed breathing.||
0057|187|B|||
0057|188|N|NOTES:  Do not share this medication with others.||
0057|189|N|   Lab and/or medical tests (such as phenytoin blood levels,||
0057|190|N|liver function, complete blood count) should be done while you||
0057|191|N|are taking this medication. Keep all medical and lab||
0057|192|N|appointments. Consult your doctor for more details.||
0057|193|N|   Do not change from one brand of this product to another, or to||
0057|194|N|another dose form of this drug (such as immediate release||
0057|195|N|capsule, liquid suspension, or chewable tablet) without||
0057|196|N|consulting your doctor or pharmacist. Your dosage may have to be||
0057|197|N|adjusted.||
0057|198|B|||
0057|199|D|MISSED DOSE:  If you miss your once daily dose, take it as soon||
0057|200|D|as you remember. If you don't remember until the next day, skip||
0057|201|D|the missed dose. Take your next dose at the regular time. Do not||
0057|202|D|double the dose to catch up.||
0057|203|D|   If you take several doses daily and miss a dose, take it as||
0057|204|D|soon as you remember. If it is within 4 hours of the next dose,||
0057|205|D|skip the missed dose. Take your next dose at the regular time. Do||
0057|206|D|not double the dose to catch up. Check with your doctor if you||
0057|207|D|miss doses for more than 2 days in a row.||
0057|208|B|||
0057|209|R|STORAGE:  Store at room temperature away from light and moisture.||
0057|210|R|Do not store in the bathroom. Keep all medications away from||
0057|211|R|children and pets.||
0057|212|R|   Do not flush medications down the toilet or pour them into a||
0057|213|R|drain unless instructed to do so. Properly discard this product||
0057|214|R|when it is expired or no longer needed. Consult your pharmacist||
0057|215|R|or local waste disposal company.||
0057|216|B|||
0057|217|M|MEDICAL ALERT:  Your condition can cause complications in a||
0057|218|M|medical emergency. For information about enrolling in MedicAlert,||
0057|219|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0057|220|B|||
0057|221|A|Information last revised October 2024.||
0057|222|A|Copyright(c) 2025 First Databank, Inc.||
0057|223|B|||
0058|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0058|002|Z|does NOT have all possible information about this product. This||
0058|003|Z|information does not assure that this product is safe, effective,||
0058|004|Z|or appropriate for you. This information is not individual||
0058|005|Z|medical advice and does not substitute for the advice of your||
0058|006|Z|health care professional. Always ask your health care||
0058|007|Z|professional for complete information about this product and your||
0058|008|Z|specific health needs.||
0058|009|B|||
0058|010|T|POTASSIUM SUPPLEMENT - ORAL||
0058|011|F|(poe-TAS-ee-um)||
0058|012|B|||
0058|013|U|USES:  This medication is a mineral supplement used to treat or||
0058|014|U|prevent low amounts of potassium in the blood. A normal level of||
0058|015|U|potassium in the blood is important. Potassium helps your cells,||
0058|016|U|kidneys, heart, muscles, and nerves work properly. Most people||
0058|017|U|get enough potassium by eating a well-balanced diet. Some||
0058|018|U|conditions that can lower your body's potassium level include||
0058|019|U|severe prolonged diarrhea and vomiting, hormone problems such as||
0058|020|U|hyperaldosteronism, or treatment with "water pills"/diuretics.||
0058|021|B|||
0058|022|H|HOW TO USE:  If you are taking the over-the-counter product to||
0058|023|H|self-treat, read all directions on the product package before||
0058|024|H|taking this medication. If you have any questions, consult your||
0058|025|H|pharmacist. If your doctor has prescribed this medication, take||
0058|026|H|it as directed. To prevent stomach upset, take each dose with a||
0058|027|H|meal and a full glass of water (8 ounces/240 milliliters) unless||
0058|028|H|your doctor directs you otherwise. Do not lie down for at least||
0058|029|H|10 minutes after taking this medication.||
0058|030|H|   Do not crush, chew, or suck extended-release capsules or||
0058|031|H|tablets. Doing so can release all of the drug at once, increasing||
0058|032|H|the risk of side effects. Also, do not split extended-release||
0058|033|H|tablets unless they have a score line and your doctor or||
0058|034|H|pharmacist tells you to do so. Swallow the whole or split tablet||
0058|035|H|without crushing or chewing.||
0058|036|H|   Take this medication by mouth as directed by your doctor or||
0058|037|H|the product package, usually once daily. Take this medication||
0058|038|H|regularly to get the most benefit from it. To help you remember,||
0058|039|H|take it at the same time each day. The dosage is based on your||
0058|040|H|medical condition and response to treatment. Do not increase your||
0058|041|H|dose or take it more often than directed.||
0058|042|H|   Tell your doctor if you think you may have a serious medical||
0058|043|H|problem or if you have symptoms of low potassium in the blood||
0058|044|H|(such as irregular heartbeat, muscle weakness/cramps).||
0058|045|B|||
0058|046|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, gas, or diarrhea||
0058|047|S|may occur. If any of these effects last or get worse, tell your||
0058|048|S|doctor or pharmacist promptly.||
0058|049|S|   If your doctor has directed you to use this medication,||
0058|050|S|remember that your doctor has judged that the benefit to you is||
0058|051|S|greater than the risk of side effects. Many people using this||
0058|052|S|medication do not have serious side effects.||
0058|053|S|   Tell your doctor right away if you have any serious side||
0058|054|S|effects, including: difficult/painful swallowing, feeling as if||
0058|055|S|the capsule/tablet is stuck in your throat.||
0058|056|S|   Get medical help right away if you have any very serious side||
0058|057|S|effects, including: vomit that looks like coffee grounds,||
0058|058|S|stomach/abdominal pain, black/tarry stools.||
0058|059|S|   A very serious allergic reaction to this drug is rare.||
0058|060|S|However, get medical help right away if you notice any symptoms||
0058|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0058|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0058|063|S|breathing.||
0058|064|S|   This is not a complete list of possible side effects. If you||
0058|065|S|notice other effects not listed above, contact your doctor or||
0058|066|S|pharmacist.||
0058|067|S|   In the US -||
0058|068|S|   Call your doctor for medical advice about side effects. You||
0058|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0058|070|S|www.fda.gov/medwatch.||
0058|071|S|   In Canada - Call your doctor for medical advice about side||
0058|072|S|effects. You may report side effects to Health Canada at||
0058|073|S|1-866-234-2345.||
0058|074|B|||
0058|075|P|PRECAUTIONS:  Before taking potassium, tell your doctor or||
0058|076|P|pharmacist if you have any allergies. This product may contain||
0058|077|P|inactive ingredients, which can cause allergic reactions or other||
0058|078|P|problems. Talk to your pharmacist for more details.||
0058|079|P|   Before using this medication, tell your doctor or pharmacist||
0058|080|P|your medical history, especially of: heart problems, kidney||
0058|081|P|problems, high levels of potassium in the blood.||
0058|082|P|   Due to rare reports of stomach/intestinal ulcers and bleeding||
0058|083|P|with sustained-release potassium products, taking a liquid form||
0058|084|P|of potassium is preferred. Tell your doctor or pharmacist if you||
0058|085|P|have throat/stomach/intestinal problems such as blockage,||
0058|086|P|narrowing, or ulcers.||
0058|087|P|   Before having surgery, tell your doctor or dentist about all||
0058|088|P|the products you use (including prescription drugs,||
0058|089|P|nonprescription drugs, and herbal products).||
0058|090|P|   Before using other potassium supplements or salt substitutes||
0058|091|P|that contain potassium, consult your doctor or pharmacist. Too||
0058|092|P|much potassium may cause serious side effects. (See also Overdose||
0058|093|P|section.)||
0058|094|P|   During pregnancy, this medication should be used only when||
0058|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
0058|096|P|   Potassium passes into breast milk. Consult your doctor before||
0058|097|P|breastfeeding.||
0058|098|B|||
0058|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0058|100|I|medications work or increase your risk for serious side effects.||
0058|101|I|This document does not contain all possible drug interactions.||
0058|102|I|Keep a list of all the products you use (including||
0058|103|I|prescription/nonprescription drugs and herbal products) and share||
0058|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
0058|105|I|the dosage of any medicines without your doctor's approval.||
0058|106|I|   Tell your doctor or pharmacist if you are regularly taking||
0058|107|I|other medications that can also raise your potassium level.||
0058|108|I|Examples include drospirenone, eplerenone, ACE inhibitors (such||
0058|109|I|as enalapril, lisinopril), angiotensin receptor blockers (such as||
0058|110|I|losartan, valsartan), potassium-sparing "water pills"/diuretics||
0058|111|I|(such as spironolactone, triamterene), among others.||
0058|112|I|   Also, tell your doctor or pharmacist if you take medications||
0058|113|I|that can slow down the movement of potassium in your stomach or||
0058|114|I|intestines, possibly increasing the risk of side effects (such as||
0058|115|I|ulcers). Examples include atropine, scopolamine, some||
0058|116|I|antihistamines such as diphenhydramine, antispasmodic drugs such||
0058|117|I|as dicyclomine/hyoscyamine, bladder control drugs such as||
0058|118|I|oxybutynin/tolterodine, certain drugs for Parkinson's disease||
0058|119|I|such as benztropine/trihexyphenidyl, among others.||
0058|120|B|||
0058|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0058|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0058|123|O|poison control center right away. US residents can call||
0058|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0058|125|O|Symptoms of overdose may include irregular heartbeat, muscle||
0058|126|O|weakness, confusion.||
0058|127|B|||
0058|128|N|NOTES:  Keep all medical and lab appointments.||
0058|129|N|   Eat a well-balanced diet. Foods high in potassium include||
0058|130|N|bananas, oranges, cantaloupe, raisins, dates, prunes, avocados,||
0058|131|N|apricots, beans, broccoli, spinach, potatoes, lentils, chicken,||
0058|132|N|turkey, beef, and yogurt. Consult your doctor or dietician for||
0058|133|N|recommended foods.||
0058|134|B|||
0058|135|D|MISSED DOSE:  If you are taking this product on a regular||
0058|136|D|schedule and miss a dose, take it as soon as you remember. If it||
0058|137|D|is near the time of the next dose, skip the missed dose. Take||
0058|138|D|your next dose at the regular time. Do not double the dose to||
0058|139|D|catch up.||
0058|140|B|||
0058|141|R|STORAGE:  Store at room temperature away from light and moisture.||
0058|142|R|Do not store in the bathroom. Keep all medications away from||
0058|143|R|children and pets.||
0058|144|R|   Do not flush medications down the toilet or pour them into a||
0058|145|R|drain unless instructed to do so. Properly discard this product||
0058|146|R|when it is expired or no longer needed. Consult your pharmacist||
0058|147|R|or local waste disposal company.||
0058|148|B|||
0058|149|A|Information last revised May 2024.||
0058|150|A|Copyright(c) 2025 First Databank, Inc.||
0058|151|B|||
0059|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0059|002|Z|does NOT have all possible information about this product. This||
0059|003|Z|information does not assure that this product is safe, effective,||
0059|004|Z|or appropriate for you. This information is not individual||
0059|005|Z|medical advice and does not substitute for the advice of your||
0059|006|Z|health care professional. Always ask your health care||
0059|007|Z|professional for complete information about this product and your||
0059|008|Z|specific health needs.||
0059|009|B|||
0059|010|T|NITROFURANTOIN - ORAL||
0059|011|F|(NYE-troe-fure-AN-toyn)||
0059|012|B|||
0059|013|C|COMMON BRAND NAME(S): Macrodantin||
0059|014|B|||
0059|015|U|USES:  This medication is used to treat or prevent certain||
0059|016|U|urinary tract infections.||
0059|017|U|   This medication is an antibiotic that works by stopping the||
0059|018|U|growth of bacteria. It will not work for viral infections (such||
0059|019|U|as common cold, flu). Unnecessary use or overuse of any||
0059|020|U|antibiotic can lead to its decreased effectiveness.||
0059|021|U|   Nitrofurantoin should not be used by children less than one||
0059|022|U|month of age due to the risk of a certain blood problem||
0059|023|U|(hemolytic anemia).||
0059|024|B|||
0059|025|H|HOW TO USE:  Take this medication by mouth with food or milk as||
0059|026|H|directed by your doctor. This medication is usually taken four||
0059|027|H|times daily to treat an infection or once daily at bedtime to||
0059|028|H|prevent infections. Swallow the medication whole. Avoid using||
0059|029|H|magnesium trisilicate-containing antacids while taking this||
0059|030|H|medication. Magnesium trisilicate-containing antacids bind with||
0059|031|H|nitrofurantoin, preventing its full absorption.||
0059|032|H|   The dosage and duration is based on your medical condition and||
0059|033|H|response to treatment. Children's dosage is also based on weight.||
0059|034|H|   For the best effect, take this antibiotic at evenly spaced||
0059|035|H|times. To help you remember, take this medication at the same||
0059|036|H|time(s) every day.||
0059|037|H|   When taking this medication to prevent infection, take it||
0059|038|H|exactly as directed by your doctor. Do not skip doses or stop||
0059|039|H|taking it without your doctor's approval. Inform your doctor if||
0059|040|H|you notice signs of a new urinary tract infection (such as pain||
0059|041|H|while you are urinating).||
0059|042|H|   If you are taking this medication to treat an infection,||
0059|043|H|continue to take this medication until the full prescribed amount||
0059|044|H|is finished, even if symptoms disappear after a few days.||
0059|045|H|Stopping the medication too early may result in a return of the||
0059|046|H|infection.||
0059|047|H|   Tell your doctor if your condition lasts or gets worse.||
0059|048|B|||
0059|049|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, headache, or||
0059|050|S|diarrhea may occur. Take this medication with food to help||
0059|051|S|minimize nausea. If any of these effects last or get worse,||
0059|052|S|notify your doctor or pharmacist promptly.||
0059|053|S|   This medication may cause your urine to turn dark yellow or||
0059|054|S|brown in color. This effect is harmless and will disappear when||
0059|055|S|the medication is stopped.||
0059|056|S|   Remember that this medication has been prescribed because your||
0059|057|S|doctor has judged that the benefit to you is greater than the||
0059|058|S|risk of side effects. Many people using this medication do not||
0059|059|S|have serious side effects.||
0059|060|S|   This medication may rarely cause very serious (possibly fatal)||
0059|061|S|lung problems. Lung problems may occur within the first month of||
0059|062|S|treatment or after long-term use of nitrofurantoin (generally for||
0059|063|S|6 months or longer). Get medical help right away if you develop||
0059|064|S|symptoms of lung problems, including: cough that doesn't go away,||
0059|065|S|chest pain, shortness of breath/trouble breathing, joint/muscle||
0059|066|S|pain, bluish/purplish skin.||
0059|067|S|   Tell your doctor right away if you have any serious side||
0059|068|S|effects, including: headache that is severe or doesn't go away,||
0059|069|S|new signs of infection (such as sore throat that doesn't go away,||
0059|070|S|fever, chills), easy bruising/bleeding, mental/mood changes,||
0059|071|S|vision changes.||
0059|072|S|   This drug may rarely cause serious (possibly fatal) liver||
0059|073|S|disease, blood or nerve problems. Tell your doctor right away if||
0059|074|S|you notice any of the following serious side effects:||
0059|075|S|nausea/vomiting that doesn't stop, unusual tiredness, dark urine,||
0059|076|S|yellowing of eyes/skin, fast/pounding heartbeat,||
0059|077|S|numbness/tingling of the arms/legs, muscle weakness.||
0059|078|S|   This medication may rarely cause a severe intestinal condition||
0059|079|S|due to a bacteria called C. difficile. This condition may occur||
0059|080|S|during treatment or weeks to months after treatment has stopped.||
0059|081|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0059|082|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0059|083|S|stool.||
0059|084|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0059|085|S|products because they may make symptoms worse.||
0059|086|S|   Use of this medication for prolonged or repeated periods may||
0059|087|S|result in oral thrush or a new vaginal yeast infection (such as||
0059|088|S|oral or vaginal fungal infection). Contact your doctor if you||
0059|089|S|notice white patches in your mouth, a change in vaginal||
0059|090|S|discharge, or other new symptoms.||
0059|091|S|   A very serious allergic reaction to this drug is rare.||
0059|092|S|However, get medical help right away if you notice any symptoms||
0059|093|S|of a serious allergic reaction, including: rash, itching/swelling||
0059|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0059|095|S|breathing.||
0059|096|S|   This is not a complete list of possible side effects. If you||
0059|097|S|notice other effects not listed above, contact your doctor or||
0059|098|S|pharmacist.||
0059|099|S|   In the US -||
0059|100|S|   Call your doctor for medical advice about side effects. You||
0059|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0059|102|S|www.fda.gov/medwatch.||
0059|103|S|   In Canada - Call your doctor for medical advice about side||
0059|104|S|effects. You may report side effects to Health Canada at||
0059|105|S|1-866-234-2345.||
0059|106|B|||
0059|107|P|PRECAUTIONS:  Before taking nitrofurantoin, tell your doctor or||
0059|108|P|pharmacist if you are allergic to it; or if you have any other||
0059|109|P|allergies. This product may contain inactive ingredients, which||
0059|110|P|can cause allergic reactions or other problems. Talk to your||
0059|111|P|pharmacist for more details.||
0059|112|P|   Before using this medication, tell your doctor or pharmacist||
0059|113|P|your medical history, especially of: kidney disease, liver||
0059|114|P|disease (including liver problems caused by nitrofurantoin in the||
0059|115|P|past), a certain genetic condition (G-6-PD deficiency), certain||
0059|116|P|blood disorders (such as anemia), lung diseases, certain nerve||
0059|117|P|problems (peripheral neuropathy), certain eye diseases (optic||
0059|118|P|neuritis), diabetes, untreated mineral imbalance, vitamin B||
0059|119|P|deficiency.||
0059|120|P|   Nitrofurantoin may cause live bacterial vaccines (such as||
0059|121|P|typhoid vaccine) to not work well. Tell your health care||
0059|122|P|professional that you are using nitrofurantoin before having any||
0059|123|P|immunizations/vaccinations.||
0059|124|P|   Older adults may be at a greater risk for side effects while||
0059|125|P|using this drug, especially nerve, liver or lung problems.||
0059|126|P|   During pregnancy, this medication should be used only when||
0059|127|P|clearly needed. This medication should not be used if you are||
0059|128|P|near or at the time of delivery (weeks 38-42 of pregnancy) due to||
0059|129|P|possible harm to the newborn, such as a certain blood problem||
0059|130|P|(hemolytic anemia). Discuss the risks and benefits with your||
0059|131|P|doctor.||
0059|132|P|   This medication passes into breast milk and may have||
0059|133|P|undesirable effects on nursing infants less than one month old||
0059|134|P|and infants with a certain genetic condition (G-6-PD deficiency).||
0059|135|P|Consult your doctor before breastfeeding.||
0059|136|B|||
0059|137|I|DRUG INTERACTIONS:  See also the How to Use section.||
0059|138|I|   Drug interactions may change how your medications work or||
0059|139|I|increase your risk for serious side effects. This document does||
0059|140|I|not contain all possible drug interactions. Keep a list of all||
0059|141|I|the products you use (including prescription/nonprescription||
0059|142|I|drugs and herbal products) and share it with your doctor and||
0059|143|I|pharmacist. Do not start, stop, or change the dosage of any||
0059|144|I|medicines without your doctor's approval.||
0059|145|I|   This medication may interfere with certain lab tests (such as||
0059|146|I|certain urine glucose tests), possibly causing false test||
0059|147|I|results. Make sure lab personnel and all your doctors know you||
0059|148|I|use this drug.||
0059|149|B|||
0059|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0059|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0059|152|O|poison control center right away. US residents can call||
0059|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0059|154|B|||
0059|155|N|NOTES:  Do not share this medication with others.||
0059|156|N|   This medication has been prescribed for your current condition||
0059|157|N|only. Do not use it later for another infection unless your||
0059|158|N|doctor tells you to.||
0059|159|N|   Lab and/or medical tests (such as complete blood counts, tests||
0059|160|N|for kidney and liver function, urine cultures) should be done||
0059|161|N|while you are taking this medication. Keep all medical and lab||
0059|162|N|appointments. Consult your doctor for more details.||
0059|163|B|||
0059|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0059|165|D|remember. If it is near the time of the next dose, skip the||
0059|166|D|missed dose. Take your next dose at the regular time. Do not||
0059|167|D|double the dose to catch up.||
0059|168|B|||
0059|169|R|STORAGE:  Store at room temperature away from light and moisture.||
0059|170|R|Do not store in the bathroom. Keep all medications away from||
0059|171|R|children and pets.||
0059|172|R|   Do not flush medications down the toilet or pour them into a||
0059|173|R|drain unless instructed to do so. Properly discard this product||
0059|174|R|when it is expired or no longer needed. Consult your pharmacist||
0059|175|R|or local waste disposal company.||
0059|176|B|||
0059|177|A|Information last revised April 2025.||
0059|178|A|Copyright(c) 2025 First Databank, Inc.||
0059|179|B|||
0060|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0060|002|Z|does NOT have all possible information about this product. This||
0060|003|Z|information does not assure that this product is safe, effective,||
0060|004|Z|or appropriate for you. This information is not individual||
0060|005|Z|medical advice and does not substitute for the advice of your||
0060|006|Z|health care professional. Always ask your health care||
0060|007|Z|professional for complete information about this product and your||
0060|008|Z|specific health needs.||
0060|009|B|||
0060|010|T|PRAZOSIN - ORAL||
0060|011|F|(PRAY-zoe-sin)||
0060|012|B|||
0060|013|C|COMMON BRAND NAME(S): Minipress||
0060|014|B|||
0060|015|U|USES:  Prazosin is used with or without other medications to||
0060|016|U|treat high blood pressure. Lowering high blood pressure helps||
0060|017|U|prevent strokes, heart attacks, and kidney problems.||
0060|018|U|   Prazosin belongs to a class of medications called alpha||
0060|019|U|blockers. It works by relaxing and widening blood vessels so||
0060|020|U|blood can flow more easily.||
0060|021|B|||
0060|022|V|OTHER USES:  This section contains uses of this drug that are not||
0060|023|V|listed in the approved professional labeling for the drug but||
0060|024|V|that may be prescribed by your health care professional. Use this||
0060|025|V|drug for a condition that is listed in this section only if it||
0060|026|V|has been so prescribed by your health care professional.||
0060|027|V|   This drug may also be used for certain blood circulation||
0060|028|V|disorders (Raynaud's phenomenon). It may also be used for||
0060|029|V|problems urinating due to an enlarged prostate (benign prostatic||
0060|030|V|hyperplasia) or to help your body "pass," or get rid of, kidney||
0060|031|V|stones through urination.||
0060|032|B|||
0060|033|H|HOW TO USE:  Take this medication by mouth with or without food||
0060|034|H|as directed by your doctor, usually two or three times daily. If||
0060|035|H|stomach upset occurs, take with food or milk. The dosage is based||
0060|036|H|on your age, medical condition and response to treatment.||
0060|037|H|   Prazosin can occasionally cause sudden fainting after the||
0060|038|H|first dose and anytime that your dose is increased. To reduce||
0060|039|H|your risk of fainting, the first dose prescribed by your doctor||
0060|040|H|will be the smallest dose available. You should take this first||
0060|041|H|dose as you are going to bed. This will decrease the possibility||
0060|042|H|of fainting. Your dose may be gradually increased. Take your||
0060|043|H|first new dose at bedtime when your dose is increased unless||
0060|044|H|directed otherwise by your doctor.||
0060|045|H|   Use this medication regularly in order to get the most benefit||
0060|046|H|from it. To help you remember, take it at the same time(s) each||
0060|047|H|day. If you are taking this medication for high blood pressure,||
0060|048|H|keep taking it even if you feel well. Most people with high blood||
0060|049|H|pressure do not feel sick. It may take up to several weeks before||
0060|050|H|the full benefit of this drug takes effect.||
0060|051|H|   Do not stop taking this medication without first consulting||
0060|052|H|your doctor. Some conditions may become worse when the drug is||
0060|053|H|abruptly stopped. Your dose may need to be gradually decreased.||
0060|054|H|   Tell your doctor if your condition does not get better or if||
0060|055|H|it gets worse (your blood pressure readings remain high or||
0060|056|H|increase).||
0060|057|B|||
0060|058|S|SIDE EFFECTS:  Headache, drowsiness, tiredness, weakness, blurred||
0060|059|S|vision, nausea, vomiting, diarrhea, or constipation may occur as||
0060|060|S|your body adjusts to the medication. If any of these effects last||
0060|061|S|or get worse, tell your doctor or pharmacist promptly.||
0060|062|S|   Lightheadedness or dizziness upon standing may also occur,||
0060|063|S|especially after the first dose and shortly after taking a dose||
0060|064|S|of the drug during the first week of treatment. To reduce the||
0060|065|S|risk of dizziness and fainting, get up slowly when rising from a||
0060|066|S|seated or lying position. If dizziness occurs, sit or lie down||
0060|067|S|right away. Your dose may need to be adjusted.||
0060|068|S|   Remember that this medication has been prescribed because your||
0060|069|S|doctor has judged that the benefit to you is greater than the||
0060|070|S|risk of side effects. Many people using this medication do not||
0060|071|S|have serious side effects.||
0060|072|S|   Tell your doctor right away if you have any serious side||
0060|073|S|effects, including: pounding heartbeat, fainting, frequent||
0060|074|S|urination, mental/mood changes (such as depression), swelling of||
0060|075|S|the feet/ankles.||
0060|076|S|   Rarely, males may have a painful or prolonged erection lasting||
0060|077|S|4 or more hours. If this occurs, stop using this drug and get||
0060|078|S|medical help right away, or permanent problems could occur.||
0060|079|S|   A very serious allergic reaction to this drug is rare.||
0060|080|S|However, get medical help right away if you notice any symptoms||
0060|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0060|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0060|083|S|breathing.||
0060|084|S|   This is not a complete list of possible side effects. If you||
0060|085|S|notice other effects not listed above, contact your doctor or||
0060|086|S|pharmacist.||
0060|087|S|   In the US -||
0060|088|S|   Call your doctor for medical advice about side effects. You||
0060|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0060|090|S|www.fda.gov/medwatch.||
0060|091|S|   In Canada - Call your doctor for medical advice about side||
0060|092|S|effects. You may report side effects to Health Canada at||
0060|093|S|1-866-234-2345.||
0060|094|B|||
0060|095|P|PRECAUTIONS:  Before taking prazosin, tell your doctor or||
0060|096|P|pharmacist if you are allergic to it; or to other alpha blockers||
0060|097|P|(such as doxazosin, terazosin); or if you have any other||
0060|098|P|allergies. This product may contain inactive ingredients, which||
0060|099|P|can cause allergic reactions or other problems. Talk to your||
0060|100|P|pharmacist for more details.||
0060|101|P|   Before using this medication, tell your doctor or pharmacist||
0060|102|P|your medical history, especially of: heart problems (such as low||
0060|103|P|blood pressure), kidney disease, uncontrolled attacks of deep||
0060|104|P|sleep (narcolepsy), prostate cancer, certain eye problems||
0060|105|P|(cataracts, glaucoma).||
0060|106|P|   This drug may make you dizzy or drowsy or blur your vision.||
0060|107|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0060|108|P|drowsy. Do not drive, use machinery, or do anything that needs||
0060|109|P|alertness or clear vision until you can do it safely. Do not||
0060|110|P|drive or participate in hazardous activities for 24 hours after||
0060|111|P|your first dose, any increase in your dosage, or restarting||
0060|112|P|treatment. If your doctor prescribes any additional blood||
0060|113|P|pressure drugs, avoid driving and hazardous activities for 24||
0060|114|P|hours after your first dose of the new medication. Limit||
0060|115|P|alcoholic beverages. Talk to your doctor if you are using||
0060|116|P|marijuana (cannabis).||
0060|117|P|   To reduce the risk of dizziness and fainting, be careful when||
0060|118|P|standing for long periods. Avoid getting overheated during||
0060|119|P|exercise and hot weather. When first starting this drug, avoid||
0060|120|P|situations where you may be injured if you faint.||
0060|121|P|   Before having surgery (including cataract/glaucoma eye||
0060|122|P|surgery), tell your doctor or dentist if you are taking or have||
0060|123|P|ever taken this medication, and about all the other products you||
0060|124|P|use (including prescription drugs, nonprescription drugs, and||
0060|125|P|herbal products).||
0060|126|P|   Older adults may be more sensitive to the side effects of this||
0060|127|P|drug, especially dizziness and fainting. These side effects can||
0060|128|P|increase the risk of falling.||
0060|129|P|   During pregnancy, this medication should be used only when||
0060|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
0060|131|P|   Prazosin passes into breast milk. Consult your doctor before||
0060|132|P|breastfeeding.||
0060|133|B|||
0060|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0060|135|I|medications work or increase your risk for serious side effects.||
0060|136|I|This document does not contain all possible drug interactions.||
0060|137|I|Keep a list of all the products you use (including||
0060|138|I|prescription/nonprescription drugs and herbal products) and share||
0060|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
0060|140|I|the dosage of any medicines without your doctor's approval.||
0060|141|I|   Some products that may interact with this drug include: other||
0060|142|I|alpha blocker drugs (such as doxazosin, terazosin), drugs to||
0060|143|I|treat erectile dysfunction-ED or pulmonary hypertension (such as||
0060|144|I|sildenafil, tadalafil).||
0060|145|I|   Tell your doctor or pharmacist if you are taking other||
0060|146|I|products that cause drowsiness such as opioid pain or cough||
0060|147|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0060|148|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0060|149|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0060|150|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0060|151|I|diphenhydramine).||
0060|152|I|   Check the labels on all your medicines (such as allergy or||
0060|153|I|cough-and-cold products) because they may contain ingredients||
0060|154|I|that cause drowsiness. Ask your pharmacist about using those||
0060|155|I|products safely.||
0060|156|I|   Some products have ingredients that could raise your heart||
0060|157|I|rate or blood pressure. Tell your pharmacist what products you||
0060|158|I|are using, and ask how to use them safely (especially||
0060|159|I|cough-and-cold products, diet aids, or NSAIDs such as||
0060|160|I|ibuprofen/naproxen).||
0060|161|I|   This medication may interfere with certain lab tests (such as||
0060|162|I|pheochromocytoma screening test), possibly causing false test||
0060|163|I|results. Make sure lab personnel and all your doctors know you||
0060|164|I|use this drug.||
0060|165|B|||
0060|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0060|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0060|168|O|poison control center right away. US residents can call||
0060|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0060|170|O|Symptoms of overdose may include: severe drowsiness, slow||
0060|171|O|reactions.||
0060|172|B|||
0060|173|N|NOTES:  Do not share this medication with others.||
0060|174|N|   Lifestyle changes such as stress reduction programs, exercise,||
0060|175|N|and dietary changes may increase the effectiveness of this||
0060|176|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0060|177|N|changes that might benefit you.||
0060|178|N|   Have your blood pressure and heart rate checked regularly||
0060|179|N|while taking this medication. Learn how to monitor your own blood||
0060|180|N|pressure, and share the results with your doctor.||
0060|181|B|||
0060|182|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0060|183|D|remember. If it is near the time of the next dose, skip the||
0060|184|D|missed dose. Take your next dose at the regular time. Do not||
0060|185|D|double the dose to catch up.||
0060|186|B|||
0060|187|R|STORAGE:  Store at room temperature away from light and moisture.||
0060|188|R|Do not store in the bathroom. Keep all medications away from||
0060|189|R|children and pets.||
0060|190|R|   Do not flush medications down the toilet or pour them into a||
0060|191|R|drain unless instructed to do so. Properly discard this product||
0060|192|R|when it is expired or no longer needed. Consult your pharmacist||
0060|193|R|or local waste disposal company.||
0060|194|B|||
0060|195|A|Information last revised May 2024.||
0060|196|A|Copyright(c) 2025 First Databank, Inc.||
0060|197|B|||
0062|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0062|002|Z|does NOT have all possible information about this product. This||
0062|003|Z|information does not assure that this product is safe, effective,||
0062|004|Z|or appropriate for you. This information is not individual||
0062|005|Z|medical advice and does not substitute for the advice of your||
0062|006|Z|health care professional. Always ask your health care||
0062|007|Z|professional for complete information about this product and your||
0062|008|Z|specific health needs.||
0062|009|B|||
0062|010|T|PROBENECID - ORAL||
0062|011|F|(proe-BEN-e-sid)||
0062|012|B|||
0062|013|C|COMMON BRAND NAME(S): Benemid||
0062|014|B|||
0062|015|U|USES:  This medication is used to prevent gout and gouty||
0062|016|U|arthritis. It will not treat a sudden/severe attack of gout and||
0062|017|U|may make it worse. Probenecid belongs to a class of drugs known||
0062|018|U|as uricosurics. It lowers high levels of uric acid in your body||
0062|019|U|by helping the kidneys to get rid of uric acid. When uric acid||
0062|020|U|levels get too high, crystals can form in the joints, causing||
0062|021|U|gout. Lowering uric acid levels may also help your kidneys.||
0062|022|U|   Probenecid may be prescribed in combination with certain||
0062|023|U|antibiotics (such as penicillins). It increases the levels of||
0062|024|U|antibiotic in the blood, which helps the antibiotic work better.||
0062|025|U|   Probenecid should not be used by children younger than 2||
0062|026|U|years.||
0062|027|B|||
0062|028|H|HOW TO USE:  To prevent gout, take this medication by mouth as||
0062|029|H|directed by your doctor, usually twice daily with food or||
0062|030|H|antacids to reduce stomach upset. It is best to drink a full||
0062|031|H|glass of water with each dose and at least another 8 glasses (8||
0062|032|H|ounces each) a day while taking this drug in order to prevent||
0062|033|H|kidney stones. If you are on restricted fluid intake, consult||
0062|034|H|your doctor for further instructions. Your doctor may also||
0062|035|H|instruct you on how to decrease acidity in your urine (such as by||
0062|036|H|avoiding large amounts of ascorbic acid/vitamin C) to prevent||
0062|037|H|kidney stones. Your doctor may order other medications (such as||
0062|038|H|sodium bicarbonate, citrate) to make your urine less acidic.||
0062|039|H|   The dosage is based on your condition and response to||
0062|040|H|treatment. Your doctor may direct you to take a low dose at||
0062|041|H|first, then adjust your dose based on uric acid levels and your||
0062|042|H|gout symptoms. After you have been symptom-free for several||
0062|043|H|months and your uric acid levels are normal, your doctor may||
0062|044|H|lower your probenecid dose to the lowest effective dose. Follow||
0062|045|H|your doctor's directions carefully.||
0062|046|H|   Probenecid should not be started during a sudden/severe gout||
0062|047|H|attack. Wait until your current attack is over before starting||
0062|048|H|this medication. You may experience an increase in the number of||
0062|049|H|gout attacks for several months after starting this medicine||
0062|050|H|while the body removes extra uric acid. If you have a gout attack||
0062|051|H|while taking probenecid, keep taking it along with your||
0062|052|H|medications for gout pain.||
0062|053|H|   Probenecid is not a pain reliever. To relieve pain from gout,||
0062|054|H|continue to take your medicines prescribed for pain from gout||
0062|055|H|attacks (such as colchicine, ibuprofen, indomethacin) as directed||
0062|056|H|by your doctor.||
0062|057|H|   If you are taking this medication to raise the level of||
0062|058|H|antibiotics in your body, follow your doctor's directions for||
0062|059|H|when to take the antibiotic and when to take the probenecid.||
0062|060|H|   Use this medication regularly to get the most benefit from it.||
0062|061|H|To help you remember, take it at the same times each day.||
0062|062|H|   Tell your doctor if your condition lasts or gets worse.||
0062|063|B|||
0062|064|S|SIDE EFFECTS:  Nausea, loss of appetite, dizziness, vomiting,||
0062|065|S|headache, sore gums, or frequent urination may occur as your body||
0062|066|S|adjusts to the medicine. If any of these effects last or get||
0062|067|S|worse, tell your doctor or pharmacist promptly.||
0062|068|S|   Remember that this medication has been prescribed because your||
0062|069|S|doctor has judged that the benefit to you is greater than the||
0062|070|S|risk of side effects. Many people using this medication do not||
0062|071|S|have serious side effects.||
0062|072|S|   Tell your doctor right away if you have any serious side||
0062|073|S|effects, including: lower back pain, difficult/painful urination,||
0062|074|S|change in amount/color of urine, easy bruising/bleeding, signs of||
0062|075|S|infection (such as sore throat that doesn't go away, fever,||
0062|076|S|chills), severe abdominal pain, pale stools, unusual tiredness,||
0062|077|S|dark urine, yellowing eyes/skin.||
0062|078|S|   A very serious allergic reaction to this drug is rare.||
0062|079|S|However, get medical help right away if you notice any symptoms||
0062|080|S|of a serious allergic reaction, including: rash, itching/swelling||
0062|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0062|082|S|breathing.||
0062|083|S|   This is not a complete list of possible side effects. If you||
0062|084|S|notice other effects not listed above, contact your doctor or||
0062|085|S|pharmacist.||
0062|086|S|   In the US -||
0062|087|S|   Call your doctor for medical advice about side effects. You||
0062|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0062|089|S|www.fda.gov/medwatch.||
0062|090|S|   In Canada - Call your doctor for medical advice about side||
0062|091|S|effects. You may report side effects to Health Canada at||
0062|092|S|1-866-234-2345.||
0062|093|B|||
0062|094|P|PRECAUTIONS:  Before taking probenecid, tell your doctor or||
0062|095|P|pharmacist if you are allergic to it; or if you have any other||
0062|096|P|allergies. This product may contain inactive ingredients, which||
0062|097|P|can cause allergic reactions or other problems. Talk to your||
0062|098|P|pharmacist for more details.||
0062|099|P|   Before using this medication, tell your doctor or pharmacist||
0062|100|P|your medical history, especially of: low blood counts (such as||
0062|101|P|aplastic anemia, bone marrow depression), cancer treatment, a||
0062|102|P|certain enzyme deficiency (G6PD), kidney problems (such as kidney||
0062|103|P|stones, obstruction), peptic ulcer disease.||
0062|104|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0062|105|P|can make you more dizzy. Do not drive, use machinery, or do||
0062|106|P|anything that needs alertness until you can do it safely. Limit||
0062|107|P|alcoholic beverages. Talk to your doctor if you are using||
0062|108|P|marijuana (cannabis). Alcohol may also decrease this drug's||
0062|109|P|effectiveness.||
0062|110|P|   Before having surgery, tell your doctor or dentist about all||
0062|111|P|the products you use (including prescription drugs,||
0062|112|P|nonprescription drugs, and herbal products).||
0062|113|P|   Older adults may be more sensitive to the side effects of this||
0062|114|P|drug, especially stomach problems.||
0062|115|P|   During pregnancy, this medication should be used only when||
0062|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
0062|117|P|   This medication passes into breast milk. Consult your doctor||
0062|118|P|before breastfeeding.||
0062|119|B|||
0062|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0062|121|I|medications work or increase your risk for serious side effects.||
0062|122|I|This document does not contain all possible drug interactions.||
0062|123|I|Keep a list of all the products you use (including||
0062|124|I|prescription/nonprescription drugs and herbal products) and share||
0062|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
0062|126|I|the dosage of any medicines without your doctor's approval.||
0062|127|I|   This medication can slow down the removal of other medications||
0062|128|I|from your body, which may affect how they work. Examples of||
0062|129|I|affected drugs include irinotecan, ketoprofen, ketorolac,||
0062|130|I|methotrexate, pralatrexate among others.||
0062|131|I|   This medication may interfere with certain lab tests (such as||
0062|132|I|urine glucose tests), possibly causing false test results. Make||
0062|133|I|sure lab personnel and all your doctors know you use this drug.||
0062|134|B|||
0062|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0062|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0062|137|O|poison control center right away. US residents can call||
0062|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0062|139|O|Symptoms of overdose may include: severe vomiting, loss of||
0062|140|O|consciousness, seizures.||
0062|141|B|||
0062|142|N|NOTES:  Do not share this medication with others.||
0062|143|N|   Lab and/or medical tests (such as uric acid blood levels,||
0062|144|N|liver/kidney function, complete blood count) may be done while||
0062|145|N|you are taking this medication. Keep all medical and lab||
0062|146|N|appointments. Consult your doctor for more details.||
0062|147|N|   If you are using this medication to treat gout, your doctor||
0062|148|N|may recommend a low-purine diet. Follow your doctor's||
0062|149|N|instructions carefully.||
0062|150|B|||
0062|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0062|152|D|remember. If it is near the time of the next dose, skip the||
0062|153|D|missed dose. Take your next dose at the regular time. Do not||
0062|154|D|double the dose to catch up.||
0062|155|B|||
0062|156|R|STORAGE:  Store at room temperature away from light and moisture.||
0062|157|R|Do not store in the bathroom. Keep all medications away from||
0062|158|R|children and pets.||
0062|159|R|   Do not flush medications down the toilet or pour them into a||
0062|160|R|drain unless instructed to do so. Properly discard this product||
0062|161|R|when it is expired or no longer needed. Consult your pharmacist||
0062|162|R|or local waste disposal company.||
0062|163|B|||
0062|164|A|Information last revised August 2025.||
0062|165|A|Copyright(c) 2025 First Databank, Inc.||
0062|166|B|||
0065|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0065|002|Z|does NOT have all possible information about this product. This||
0065|003|Z|information does not assure that this product is safe, effective,||
0065|004|Z|or appropriate for you. This information is not individual||
0065|005|Z|medical advice and does not substitute for the advice of your||
0065|006|Z|health care professional. Always ask your health care||
0065|007|Z|professional for complete information about this product and your||
0065|008|Z|specific health needs.||
0065|009|B|||
0065|010|T|RIFAMPIN - ORAL||
0065|011|F|(rif-AM-pin)||
0065|012|B|||
0065|013|C|COMMON BRAND NAME(S): Rifadin, Rimactane||
0065|014|B|||
0065|015|U|USES:  This medication is used to prevent and treat tuberculosis||
0065|016|U|and other bacterial infections. Rifampin belongs to a class of||
0065|017|U|drugs known as rifamycin antibiotics. It works by stopping the||
0065|018|U|growth of bacteria.||
0065|019|U|   This antibiotic treats only bacterial infections. It will not||
0065|020|U|work for viral infections (such as common cold, flu). Using any||
0065|021|U|antibiotic when it is not needed can cause it to not work for||
0065|022|U|future infections.||
0065|023|B|||
0065|024|H|HOW TO USE:  Take this medication by mouth at least 1 hour before||
0065|025|H|or 2 hours after a meal as directed by your doctor, usually 1 or||
0065|026|H|2 times daily. Take this medication with a full glass of water (8||
0065|027|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
0065|028|H|If you need to take antacids, wait at least 1 hour after taking||
0065|029|H|rifampin.||
0065|030|H|   If you are unable to swallow the capsules, you may open the||
0065|031|H|capsule and sprinkle the contents onto applesauce or jelly. Eat||
0065|032|H|the entire mixture right away. Do not prepare a supply for future||
0065|033|H|use.||
0065|034|H|   If you are using the liquid form of this medication, shake the||
0065|035|H|bottle well before each use. Carefully measure the dose using a||
0065|036|H|special measuring device/spoon. Do not use a household spoon||
0065|037|H|because you may not get the correct dose.||
0065|038|H|   The dosage and length of treatment are based on your medical||
0065|039|H|condition, weight, and response to treatment.||
0065|040|H|   It is very important to keep using this medication (and other||
0065|041|H|medications used to treat tuberculosis) exactly as prescribed by||
0065|042|H|your doctor. Do not skip any doses.||
0065|043|H|   For the best effect, use this antibiotic at evenly spaced||
0065|044|H|times. To help you remember, use this medication at the same||
0065|045|H|time(s) every day.||
0065|046|H|   Continue to use this medication until the full prescribed||
0065|047|H|amount is finished, even if symptoms disappear after a few days.||
0065|048|H|Stopping the medication too early may result in a return of the||
0065|049|H|infection.||
0065|050|H|   Tell your doctor if your condition lasts or gets worse.||
0065|051|B|||
0065|052|S|SIDE EFFECTS:  Upset stomach, heartburn, nausea, or headache may||
0065|053|S|occur. If any of these effects last or get worse, tell your||
0065|054|S|doctor or pharmacist promptly.||
0065|055|S|   This medication may cause urine, sweat, saliva, or tears to||
0065|056|S|change color (yellow, orange, red, or brown). This effect is||
0065|057|S|harmless and will disappear when the medication is stopped.||
0065|058|S|However, teeth and contact lens staining may be permanent.||
0065|059|S|   Remember that this medication has been prescribed because your||
0065|060|S|doctor has judged that the benefit to you is greater than the||
0065|061|S|risk of side effects. Many people using this medication do not||
0065|062|S|have serious side effects.||
0065|063|S|   Tell your doctor right away if you have any serious side||
0065|064|S|effects, including: signs of kidney problems (such as change in||
0065|065|S|the amount of urine), mental/mood changes (such as confusion,||
0065|066|S|unusual behavior), unusual tiredness, easy bruising/bleeding,||
0065|067|S|small red spots on the skin, joint pain/swelling, new or||
0065|068|S|worsening shortness of breath.||
0065|069|S|   Get medical help right away if you have any very serious side||
0065|070|S|effects, including: chest pain.||
0065|071|S|   Rifampin may rarely cause serious (possibly fatal) liver||
0065|072|S|disease. Get medical help right away if you have any symptoms of||
0065|073|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
0065|074|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0065|075|S|urine.||
0065|076|S|   This medication may rarely cause a severe intestinal condition||
0065|077|S|due to a bacteria called C. difficile. This condition may occur||
0065|078|S|during treatment or weeks to months after treatment has stopped.||
0065|079|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0065|080|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0065|081|S|stool.||
0065|082|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0065|083|S|products because they may make symptoms worse.||
0065|084|S|   This medication may sometimes cause oral thrush or a new yeast||
0065|085|S|infection. Contact your doctor if you notice white patches in||
0065|086|S|your mouth, a change in vaginal discharge, or other new symptoms.||
0065|087|S|   A very serious allergic reaction to this drug is rare.||
0065|088|S|However, get medical help right away if you notice any symptoms||
0065|089|S|of a serious allergic reaction, including: fever that doesn't go||
0065|090|S|away, new or worsening lymph node swelling, rash,||
0065|091|S|itching/swelling (especially of the face/tongue/throat), severe||
0065|092|S|dizziness, trouble breathing.||
0065|093|S|   This is not a complete list of possible side effects. If you||
0065|094|S|notice other effects not listed above, contact your doctor or||
0065|095|S|pharmacist.||
0065|096|S|   In the US -||
0065|097|S|   Call your doctor for medical advice about side effects. You||
0065|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0065|099|S|www.fda.gov/medwatch.||
0065|100|S|   In Canada - Call your doctor for medical advice about side||
0065|101|S|effects. You may report side effects to Health Canada at||
0065|102|S|1-866-234-2345.||
0065|103|B|||
0065|104|P|PRECAUTIONS:  Before using rifampin, tell your doctor or||
0065|105|P|pharmacist if you are allergic to it; or other rifamycins (such||
0065|106|P|as rifabutin); or if you have any other allergies. This product||
0065|107|P|may contain inactive ingredients, which can cause allergic||
0065|108|P|reactions or other problems. Talk to your pharmacist for more||
0065|109|P|details.||
0065|110|P|   Before using this medication, tell your doctor or pharmacist||
0065|111|P|your medical history, especially of: diabetes, liver problems||
0065|112|P|(such as hepatitis), HIV infection, history of alcohol use/abuse.||
0065|113|P|   Alcohol may increase the risk of liver disease. Avoid||
0065|114|P|alcoholic beverages while using this medication.||
0065|115|P|   Rifampin may cause live bacterial vaccines (such as typhoid||
0065|116|P|vaccine) to not work well. Tell your health care professional||
0065|117|P|that you are using rifampin before having any||
0065|118|P|immunizations/vaccinations.||
0065|119|P|   Before having surgery, tell your doctor or dentist about all||
0065|120|P|the products you use (including prescription drugs,||
0065|121|P|nonprescription drugs, and herbal products).||
0065|122|P|   During pregnancy, this medication should be used only when||
0065|123|P|clearly needed. When this drug is used during the last few weeks||
0065|124|P|of pregnancy, the risk of bleeding in both mother and infant may||
0065|125|P|be increased. Tell your doctor right away if you notice any||
0065|126|P|bleeding in your newborn. Discuss the risks and benefits with||
0065|127|P|your doctor.||
0065|128|P|   Rifampin passes into breast milk but is unlikely to harm a||
0065|129|P|nursing infant. Consult your doctor before breastfeeding.||
0065|130|B|||
0065|131|I|DRUG INTERACTIONS:  See also How to Use section.||
0065|132|I|   Drug interactions may change how your medications work or||
0065|133|I|increase your risk for serious side effects. This document does||
0065|134|I|not contain all possible drug interactions. Keep a list of all||
0065|135|I|the products you use (including prescription/nonprescription||
0065|136|I|drugs and herbal products) and share it with your doctor and||
0065|137|I|pharmacist. Do not start, stop, or change the dosage of any||
0065|138|I|medicines without your doctor's approval.||
0065|139|I|   Rifampin interacts with many medications. While you are using||
0065|140|I|rifampin, it is very important to tell your doctor or pharmacist||
0065|141|I|of any changes in medications that you are taking.||
0065|142|I|   Rifampin can speed up the removal of other medications from||
0065|143|I|your body, which may affect how they work. Examples of affected||
0065|144|I|drugs include atovaquone, certain anti-cancer drugs (such as||
0065|145|I|irinotecan), certain azole antifungals (such as itraconazole),||
0065|146|I|certain calcium channel blockers (such as nifedipine), certain||
0065|147|I|products used to treat chronic hepatitis C (such as sofosbuvir),||
0065|148|I|cobicistat, lurasidone, HIV NNRTIs (such as etravirine,||
0065|149|I|nevirapine), praziquantel, HIV protease inhibitors (such as||
0065|150|I|atazanavir, darunavir), among others.||
0065|151|I|   This medication may decrease the effectiveness of hormonal||
0065|152|I|birth control such as pills, patch, or ring. This could cause||
0065|153|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0065|154|I|use reliable backup birth control methods while using this||
0065|155|I|medication. Also tell your doctor if you have any new spotting or||
0065|156|I|breakthrough bleeding, because these may be signs that your birth||
0065|157|I|control is not working well.||
0065|158|I|   This medication may interfere with certain lab tests (such as||
0065|159|I|urine screening for opiates, blood serum folate/vitamin B12),||
0065|160|I|possibly causing false test results. Rifampin may also make it||
0065|161|I|harder for your body to get rid of certain chemicals used in||
0065|162|I|gallbladder tests. Make sure lab personnel and all your doctors||
0065|163|I|know you use this drug.||
0065|164|B|||
0065|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0065|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0065|167|O|poison control center right away. US residents can call||
0065|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0065|169|B|||
0065|170|N|NOTES:  Do not share this medication with others.||
0065|171|N|   Lab and/or medical tests (such as liver/kidney function,||
0065|172|N|bilirubin, complete blood count) may be done before you start||
0065|173|N|using this medication and while you are using it. Keep all||
0065|174|N|medical and lab appointments. Consult your doctor for more||
0065|175|N|details.||
0065|176|N|   This medication has been prescribed for your current condition||
0065|177|N|only. Do not use it later for another infection unless your||
0065|178|N|doctor tells you to.||
0065|179|B|||
0065|180|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0065|181|D|remember. If it is near the time of the next dose, skip the||
0065|182|D|missed dose. Take your next dose at the regular time. Do not||
0065|183|D|double the dose to catch up.||
0065|184|D|   If you are taking this drug on a longer schedule (such as||
0065|185|D|twice weekly) and miss a dose, ask your doctor or pharmacist||
0065|186|D|right away for a new dosing schedule.||
0065|187|B|||
0065|188|R|STORAGE:  Store the capsules at room temperature away from light||
0065|189|R|and moisture. Do not store in the bathroom. Store the liquid form||
0065|190|R|in the refrigerator or at room temperature. Do not freeze. The||
0065|191|R|liquid form expires 4 weeks after it was prepared by the||
0065|192|R|pharmacy. Keep all medications away from children and pets.||
0065|193|R|   Do not flush medications down the toilet or pour them into a||
0065|194|R|drain unless instructed to do so. Properly discard this product||
0065|195|R|when it is expired or no longer needed. Consult your pharmacist||
0065|196|R|or local waste disposal company.||
0065|197|B|||
0065|198|A|Information last revised August 2024.||
0065|199|A|Copyright(c) 2025 First Databank, Inc.||
0065|200|B|||
0067|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0067|002|Z|does NOT have all possible information about this product. This||
0067|003|Z|information does not assure that this product is safe, effective,||
0067|004|Z|or appropriate for you. This information is not individual||
0067|005|Z|medical advice and does not substitute for the advice of your||
0067|006|Z|health care professional. Always ask your health care||
0067|007|Z|professional for complete information about this product and your||
0067|008|Z|specific health needs.||
0067|009|B|||
0067|010|T|SPIRONOLACTONE - ORAL||
0067|011|F|(spir-ON-oh-LAK-tone)||
0067|012|B|||
0067|013|C|COMMON BRAND NAME(S): Aldactone||
0067|014|B|||
0067|015|U|USES:  Spironolactone is used to treat high blood pressure and||
0067|016|U|heart failure. Lowering high blood pressure helps prevent||
0067|017|U|strokes, heart attacks, and kidney problems. It is also used to||
0067|018|U|treat swelling (edema) caused by certain conditions (such as||
0067|019|U|heart failure, liver disease) by removing excess fluid and||
0067|020|U|improving symptoms such as breathing problems.||
0067|021|U|   This medication is also used to treat conditions in which the||
0067|022|U|body is making too much of a natural substance (aldosterone).||
0067|023|U|   Spironolactone is known as a "water pill" (potassium-sparing||
0067|024|U|diuretic).||
0067|025|B|||
0067|026|V|OTHER USES:  This section contains uses of this drug that are not||
0067|027|V|listed in the approved professional labeling for the drug but||
0067|028|V|that may be prescribed by your health care professional. Use this||
0067|029|V|drug for a condition that is listed in this section only if it||
0067|030|V|has been so prescribed by your health care professional.||
0067|031|V|   This drug may also be used for excessive hair growth||
0067|032|V|(hirsutism) in women with polycystic ovary disease.||
0067|033|B|||
0067|034|H|HOW TO USE:  Take this medication by mouth as directed by your||
0067|035|H|doctor. If stomach upset occurs, take it with food or milk. It is||
0067|036|H|best to take your dose early in the day (before 6 p.m.) to||
0067|037|H|prevent having to get up during the night to urinate. Consult||
0067|038|H|your doctor or pharmacist if you have any questions.||
0067|039|H|   If you are using the liquid form of this medication, shake the||
0067|040|H|bottle well before each dose. Carefully measure the dose using a||
0067|041|H|special measuring device/spoon. Do not use a household spoon||
0067|042|H|because you may not get the correct dose. You may take the liquid||
0067|043|H|form of this medication with or without food, but it is important||
0067|044|H|to choose one way and take it the same way with every dose.||
0067|045|H|   The dosage is based on your medical condition and response to||
0067|046|H|treatment. Children's dosage is also based on weight.||
0067|047|H|   Take this medication regularly in order to get the most||
0067|048|H|benefit from it. Remember to use it at the same time(s) each day||
0067|049|H|as directed. Keep taking this medication even if you feel well.||
0067|050|H|Most people with high blood pressure do not feel sick.||
0067|051|H|   Take this medication exactly as prescribed. Do not increase||
0067|052|H|your dose, take it more often than prescribed, or stop using this||
0067|053|H|medicine without first consulting your doctor. Your condition may||
0067|054|H|become worse when the drug is suddenly stopped.||
0067|055|H|   Tell your doctor if your condition does not get better or if||
0067|056|H|it gets worse (for example, your blood pressure readings remain||
0067|057|H|high or increase).||
0067|058|B|||
0067|059|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, stomach||
0067|060|S|upset, diarrhea, nausea, vomiting, or headache may occur. If any||
0067|061|S|of these effects last or get worse, tell your doctor or||
0067|062|S|pharmacist promptly.||
0067|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
0067|064|S|slowly when rising from a sitting or lying position.||
0067|065|S|   Remember that this medication has been prescribed because your||
0067|066|S|doctor has judged that the benefit to you is greater than the||
0067|067|S|risk of side effects. Many people using this medication do not||
0067|068|S|have serious side effects.||
0067|069|S|   Spironolactone may cause dehydration and electrolyte||
0067|070|S|imbalance. Tell your doctor right away if you have any symptoms||
0067|071|S|of dehydration or electrolyte imbalance, including unusual dry||
0067|072|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0067|073|S|heartbeat, or confusion.||
0067|074|S|   Tell your doctor right away if you have any serious side||
0067|075|S|effects, including: signs of kidney problems (such as change in||
0067|076|S|the amount of urine), fainting, menstrual period changes, breast||
0067|077|S|pain, breast enlargement (gynecomastia) in men, sexual function||
0067|078|S|problems, vomit that looks like coffee grounds, signs of liver||
0067|079|S|problems (such as nausea/vomiting that doesn't stop, dark urine,||
0067|080|S|stomach/abdominal pain, yellowing eyes/skin), easy||
0067|081|S|bruising/bleeding.||
0067|082|S|   A very serious allergic reaction to this drug is rare.||
0067|083|S|However, get medical help right away if you notice any symptoms||
0067|084|S|of a serious allergic reaction, including: rash, itching/swelling||
0067|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0067|086|S|breathing.||
0067|087|S|   This is not a complete list of possible side effects. If you||
0067|088|S|notice other effects not listed above, contact your doctor or||
0067|089|S|pharmacist.||
0067|090|S|   In the US -||
0067|091|S|   Call your doctor for medical advice about side effects. You||
0067|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0067|093|S|www.fda.gov/medwatch.||
0067|094|S|   In Canada - Call your doctor for medical advice about side||
0067|095|S|effects. You may report side effects to Health Canada at||
0067|096|S|1-866-234-2345.||
0067|097|B|||
0067|098|P|PRECAUTIONS:  Before taking spironolactone, tell your doctor or||
0067|099|P|pharmacist if you are allergic to it; or if you have any other||
0067|100|P|allergies. This product may contain inactive ingredients, which||
0067|101|P|can cause allergic reactions or other problems. Talk to your||
0067|102|P|pharmacist for more details.||
0067|103|P|   Before using this medication, tell your doctor or pharmacist||
0067|104|P|your medical history, especially of: kidney problems, liver||
0067|105|P|problems, untreated mineral imbalance (such as high potassium,||
0067|106|P|low sodium), decreased adrenal gland function (Addison's||
0067|107|P|disease).||
0067|108|P|   Before having surgery, tell your doctor or dentist about all||
0067|109|P|the products you use (including prescription drugs,||
0067|110|P|nonprescription drugs, and herbal products).||
0067|111|P|   This medication may increase your potassium levels. Before||
0067|112|P|using potassium supplements or salt substitutes that contain||
0067|113|P|potassium, consult your doctor or pharmacist.||
0067|114|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0067|115|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0067|116|P|machinery, or do anything that needs alertness until you can do||
0067|117|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0067|118|P|are using marijuana (cannabis).||
0067|119|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0067|120|P|and cause you to feel lightheaded. Tell your doctor if you have||
0067|121|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0067|122|P|of fluids unless your doctor tells you not to.||
0067|123|P|   Older adults may be more sensitive to the side effects of this||
0067|124|P|drug, especially high potassium blood levels.||
0067|125|P|   During pregnancy, this medication should be used only when||
0067|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
0067|127|P|   This medication passes into breast milk but is unlikely to||
0067|128|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0067|129|B|||
0067|130|I|DRUG INTERACTIONS:  See also Precautions section.||
0067|131|I|   Drug interactions may change how your medications work or||
0067|132|I|increase your risk for serious side effects. This document does||
0067|133|I|not contain all possible drug interactions. Keep a list of all||
0067|134|I|the products you use (including prescription/nonprescription||
0067|135|I|drugs and herbal products) and share it with your doctor and||
0067|136|I|pharmacist. Do not start, stop, or change the dosage of any||
0067|137|I|medicines without your doctor's approval.||
0067|138|I|   Some products that may interact with this drug include:||
0067|139|I|lithium, drugs that may increase the level of potassium in the||
0067|140|I|blood (such as amiloride, cyclosporine, eplerenone, tacrolimus,||
0067|141|I|triamterene, birth control pills containing drospirenone).||
0067|142|I|   Some products have ingredients that could raise your blood||
0067|143|I|pressure or worsen your swelling. Tell your pharmacist what||
0067|144|I|products you are using, and ask how to use them safely||
0067|145|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0067|146|I|ibuprofen/naproxen).||
0067|147|I|   This medication may interfere with certain lab tests (such as||
0067|148|I|digoxin or cortisol levels), possibly causing false test results.||
0067|149|I|Make sure lab personnel and all your doctors know you use this||
0067|150|I|drug.||
0067|151|B|||
0067|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0067|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0067|154|O|poison control center right away. US residents can call||
0067|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0067|156|B|||
0067|157|N|NOTES:  Do not share this medication with others.||
0067|158|N|   Lab and/or medical tests (such as kidney/liver function, blood||
0067|159|N|mineral levels such as potassium) should be done while you are||
0067|160|N|taking this medication. Keep all medical and lab appointments.||
0067|161|N|Consult your doctor for more details.||
0067|162|N|   If you are taking this medication for high blood pressure,||
0067|163|N|lifestyle changes such as stress reduction programs, exercise,||
0067|164|N|and dietary changes may increase the effectiveness of this||
0067|165|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0067|166|N|changes that might benefit you.||
0067|167|N|   Have your blood pressure checked regularly while taking this||
0067|168|N|medication. Discuss with your doctor and learn how to monitor||
0067|169|N|your own blood pressure. Inform your doctor of your blood||
0067|170|N|pressure readings.||
0067|171|B|||
0067|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0067|173|D|remember. If it is near the time of the next dose, skip the||
0067|174|D|missed dose. Take your next dose at the regular time. Do not||
0067|175|D|double the dose to catch up.||
0067|176|B|||
0067|177|R|STORAGE:  Store at room temperature away from light and moisture.||
0067|178|R|Do not store in the bathroom. Keep all medications away from||
0067|179|R|children and pets.||
0067|180|R|   Do not flush medications down the toilet or pour them into a||
0067|181|R|drain unless instructed to do so. Properly discard this product||
0067|182|R|when it is expired or no longer needed. Consult your pharmacist||
0067|183|R|or local waste disposal company.||
0067|184|B|||
0067|185|A|Information last revised April 2025.||
0067|186|A|Copyright(c) 2025 First Databank, Inc.||
0067|187|B|||
0068|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0068|002|Z|does NOT have all possible information about this product. This||
0068|003|Z|information does not assure that this product is safe, effective,||
0068|004|Z|or appropriate for you. This information is not individual||
0068|005|Z|medical advice and does not substitute for the advice of your||
0068|006|Z|health care professional. Always ask your health care||
0068|007|Z|professional for complete information about this product and your||
0068|008|Z|specific health needs.||
0068|009|B|||
0068|010|T|SUCRALFATE - ORAL||
0068|011|F|(soo-KRAL-fate)||
0068|012|B|||
0068|013|C|COMMON BRAND NAME(S): Carafate||
0068|014|B|||
0068|015|U|USES:  This medication is used to treat and prevent ulcers in the||
0068|016|U|intestines. Sucralfate forms a coating over ulcers, protecting||
0068|017|U|the area from further injury. This helps ulcers heal more||
0068|018|U|quickly.||
0068|019|B|||
0068|020|V|OTHER USES:  This section contains uses of this drug that are not||
0068|021|V|listed in the approved professional labeling for the drug but||
0068|022|V|that may be prescribed by your health care professional. Use this||
0068|023|V|drug for a condition that is listed in this section only if it||
0068|024|V|has been so prescribed by your health care professional.||
0068|025|V|   This drug may also be used for ulcers in the stomach. It may||
0068|026|V|also be used to lessen the risk of ulcers caused by aspirin or||
0068|027|V|other anti-inflammatory drugs (such as ibuprofen, naproxen).||
0068|028|B|||
0068|029|H|HOW TO USE:  Take this medicine by mouth on an empty stomach (at||
0068|030|H|least 1 hour before a meal) as directed by your doctor, usually 2||
0068|031|H|to 4 times daily. The dosage is based on your medical condition||
0068|032|H|and response to treatment.||
0068|033|H|   Use this medication regularly in order to get the most benefit||
0068|034|H|from it. To help you remember, use it at the same times each day.||
0068|035|H|Keep taking this medication even if you do not feel ulcer pain.||
0068|036|H|Do not stop taking this medication without consulting your||
0068|037|H|doctor. It may take 4 to 8 weeks for your ulcer to heal||
0068|038|H|completely.||
0068|039|H|   Some medications may not work as well if you take them at the||
0068|040|H|same time as sucralfate. They may need to be taken at a different||
0068|041|H|time of the day than the time you take sucralfate. Ask your||
0068|042|H|doctor or pharmacist for help making a dosing schedule that will||
0068|043|H|work with all your medications.||
0068|044|H|   Antacids can be used with this medicine, but they should be||
0068|045|H|taken at least 30 minutes before or after sucralfate.||
0068|046|H|   Tell your doctor if your condition lasts or gets worse after||
0068|047|H|you have been taking sucralfate for 4 weeks.||
0068|048|B|||
0068|049|S|SIDE EFFECTS:  Constipation, dry mouth, upset stomach, gas, and||
0068|050|S|nausea may occur. If any of these effects last or get worse,||
0068|051|S|notify your doctor or pharmacist promptly.||
0068|052|S|   Remember that this medication has been prescribed because your||
0068|053|S|doctor has judged that the benefit to you is greater than the||
0068|054|S|risk of side effects. Many people using this medication do not||
0068|055|S|have serious side effects.||
0068|056|S|   Tell your doctor right away if you have any serious side||
0068|057|S|effects, including: an unusual feeling of fullness in the stomach||
0068|058|S|that doesn't go away, nausea/vomiting/stomach pain especially||
0068|059|S|after meals, difficulty swallowing.||
0068|060|S|   A very serious allergic reaction to this drug is rare.||
0068|061|S|However, get medical help right away if you notice any symptoms||
0068|062|S|of a serious allergic reaction, including: rash, itching/swelling||
0068|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0068|064|S|breathing.||
0068|065|S|   This is not a complete list of possible side effects. If you||
0068|066|S|notice other effects not listed above, contact your doctor or||
0068|067|S|pharmacist.||
0068|068|S|   In the US -||
0068|069|S|   Call your doctor for medical advice about side effects. You||
0068|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0068|071|S|www.fda.gov/medwatch.||
0068|072|S|   In Canada - Call your doctor for medical advice about side||
0068|073|S|effects. You may report side effects to Health Canada at||
0068|074|S|1-866-234-2345.||
0068|075|B|||
0068|076|P|PRECAUTIONS:  Before taking sucralfate, tell your doctor or||
0068|077|P|pharmacist if you are allergic to it; or if you have any other||
0068|078|P|allergies. This product may contain inactive ingredients, which||
0068|079|P|can cause allergic reactions or other problems. Talk to your||
0068|080|P|pharmacist for more details.||
0068|081|P|   Before using this medication, tell your doctor or pharmacist||
0068|082|P|your medical history, especially of: kidney problems, swallowing||
0068|083|P|problems (such as difficulty swallowing, history of aspiration),||
0068|084|P|stomach/intestine problems (such as delayed gastric emptying),||
0068|085|P|tube feeding, use of a breathing tube (tracheotomy).||
0068|086|P|   Before having surgery, tell your doctor or dentist about all||
0068|087|P|the products you use (including prescription drugs,||
0068|088|P|nonprescription drugs, and herbal products).||
0068|089|P|   Older adults may be at greater risk for developing high||
0068|090|P|aluminum levels while using this drug with other products that||
0068|091|P|contain aluminum (such as antacids).||
0068|092|P|   If you are pregnant, tell your doctor before using sucralfate.||
0068|093|P|   It is unknown if this medication passes into breast milk.||
0068|094|P|Consult your doctor before breastfeeding.||
0068|095|B|||
0068|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0068|097|I|medications work or increase your risk for serious side effects.||
0068|098|I|This document does not contain all possible drug interactions.||
0068|099|I|Keep a list of all the products you use (including||
0068|100|I|prescription/nonprescription drugs and herbal products) and share||
0068|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0068|102|I|the dosage of any medicines without your doctor's approval.||
0068|103|I|   Some products that may interact with this drug include:||
0068|104|I|antacids that contain aluminum, certain antibiotics (for example,||
0068|105|I|quinolones such as ciprofloxacin/levofloxacin/ofloxacin,||
0068|106|I|tetracyclines), digoxin, ketoconazole, levoketoconazole,||
0068|107|I|penicillamine, phenytoin, quinidine, thyroid medications (such as||
0068|108|I|levothyroxine, liothyronine).||
0068|109|B|||
0068|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0068|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0068|112|O|poison control center right away. US residents can call||
0068|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0068|114|B|||
0068|115|N|NOTES:  Your doctor may recommend some lifestyle changes such as||
0068|116|N|stress-reducing programs, diet changes and exercise to assist in||
0068|117|N|treatment and prevention of ulcers.||
0068|118|N|   Do not share this medication with others.||
0068|119|B|||
0068|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0068|121|D|remember. If it is near the time of the next dose, skip the||
0068|122|D|missed dose. Take your next dose at the regular time. Do not||
0068|123|D|double the dose to catch up.||
0068|124|B|||
0068|125|R|STORAGE:  Store at room temperature away from light and moisture.||
0068|126|R|Do not store in the bathroom. Keep all medications away from||
0068|127|R|children and pets.||
0068|128|R|   Do not flush medications down the toilet or pour them into a||
0068|129|R|drain unless instructed to do so. Properly discard this product||
0068|130|R|when it is expired or no longer needed. Consult your pharmacist||
0068|131|R|or local waste disposal company.||
0068|132|B|||
0068|133|A|Information last revised October 2024.||
0068|134|A|Copyright(c) 2025 First Databank, Inc.||
0068|135|B|||
0069|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0069|002|Z|does NOT have all possible information about this product. This||
0069|003|Z|information does not assure that this product is safe, effective,||
0069|004|Z|or appropriate for you. This information is not individual||
0069|005|Z|medical advice and does not substitute for the advice of your||
0069|006|Z|health care professional. Always ask your health care||
0069|007|Z|professional for complete information about this product and your||
0069|008|Z|specific health needs.||
0069|009|B|||
0069|010|T|ACYCLOVIR OINTMENT - TOPICAL||
0069|011|F|(ay-SYE-kloe-vir)||
0069|012|B|||
0069|013|C|COMMON BRAND NAME(S): Zovirax||
0069|014|B|||
0069|015|U|USES:  This medication is used to treat the first outbreak of||
0069|016|U|genital herpes infection. It is also used to treat||
0069|017|U|non-life-threatening herpes infections of the skin and around the||
0069|018|U|mouth (cold sores) in people with a weakened immune system. This||
0069|019|U|medication may decrease the length of time you have pain and help||
0069|020|U|the sores heal faster. Acyclovir is an antiviral drug. It stops||
0069|021|U|the growth of certain viruses.||
0069|022|U|   This medication does not cure herpes or prevent the infection||
0069|023|U|from coming back. Also, it does not prevent the spread of herpes||
0069|024|U|to others.||
0069|025|U|   Other antiviral medications taken by mouth may be more||
0069|026|U|effective in treating these conditions. Discuss your treatment||
0069|027|U|options with your doctor.||
0069|028|B|||
0069|029|H|HOW TO USE:  Apply this medication to skin only. Avoid getting||
0069|030|H|this medication in your eyes. If this happens, wash right away||
0069|031|H|with plenty of water.||
0069|032|H|   Begin using acyclovir as soon as symptoms of a herpes||
0069|033|H|infection appear. Wash your hands with soap and water before and||
0069|034|H|after using this medication. Clean and dry the affected areas||
0069|035|H|before applying the medication. Use a finger cot or rubber glove||
0069|036|H|when applying acyclovir to prevent spreading the infection to||
0069|037|H|other parts of your body and to other people. Apply enough||
0069|038|H|ointment to cover all sores as directed by your doctor, usually||
0069|039|H|every 3 hours, 6 times a day. Continue to use this medication for||
0069|040|H|the full time prescribed.||
0069|041|H|   Tell your doctor if your condition does not get better after 7||
0069|042|H|days of treatment or if it gets worse.||
0069|043|B|||
0069|044|S|SIDE EFFECTS:  This medication may cause mild, temporary burning||
0069|045|S|or stinging when you apply it. If either of these effects lasts||
0069|046|S|or gets worse, tell your doctor or pharmacist promptly.||
0069|047|S|   Remember that this medication has been prescribed because your||
0069|048|S|doctor has judged that the benefit to you is greater than the||
0069|049|S|risk of side effects. Many people using this medication do not||
0069|050|S|have serious side effects.||
0069|051|S|   A very serious allergic reaction to this drug is rare.||
0069|052|S|However, get medical help right away if you notice any symptoms||
0069|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0069|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0069|055|S|breathing.||
0069|056|S|   This is not a complete list of possible side effects. If you||
0069|057|S|notice other effects not listed above, contact your doctor or||
0069|058|S|pharmacist.||
0069|059|S|   In the US -||
0069|060|S|   Call your doctor for medical advice about side effects. You||
0069|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0069|062|S|www.fda.gov/medwatch.||
0069|063|S|   In Canada - Call your doctor for medical advice about side||
0069|064|S|effects. You may report side effects to Health Canada at||
0069|065|S|1-866-234-2345.||
0069|066|B|||
0069|067|P|PRECAUTIONS:  Before using acyclovir, tell your doctor or||
0069|068|P|pharmacist if you are allergic to it; or to valacyclovir; or if||
0069|069|P|you have any other allergies. This product may contain inactive||
0069|070|P|ingredients (such as polyethylene glycol), which can cause||
0069|071|P|allergic reactions or other problems. Talk to your pharmacist for||
0069|072|P|more details.||
0069|073|P|   Before using this medication, tell your doctor or pharmacist||
0069|074|P|your medical history.||
0069|075|P|   Before having surgery, tell your doctor or dentist about all||
0069|076|P|the products you use (including prescription drugs,||
0069|077|P|nonprescription drugs, and herbal products).||
0069|078|P|   Cold sores can spread easily. Avoid close physical contact||
0069|079|P|with others (such as kissing) during an outbreak until the cold||
0069|080|P|sores have completely healed. Try not to touch the cold sore. If||
0069|081|P|you do, wash your hands afterward.||
0069|082|P|   To lower the chance of giving genital herpes to your partner,||
0069|083|P|do not have sexual contact during an outbreak or if you have||
0069|084|P|symptoms. You can spread genital herpes even if you do not have||
0069|085|P|symptoms. Always use an effective barrier method (latex or||
0069|086|P|polyurethane condoms/dental dams) during all sexual activity.||
0069|087|P|Consult your doctor or pharmacist for more details.||
0069|088|P|   Tell your doctor if you are pregnant before using this||
0069|089|P|medication. Discuss the risks and benefits with your doctor.||
0069|090|P|   It is unknown if this medication passes into breast milk.||
0069|091|P|Consult your doctor before breastfeeding. Avoid breastfeeding if||
0069|092|P|you have herpes sores on or near your breast.||
0069|093|B|||
0069|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0069|095|I|medications work or increase your risk for serious side effects.||
0069|096|I|This document does not contain all possible drug interactions.||
0069|097|I|Keep a list of all the products you use (including||
0069|098|I|prescription/nonprescription drugs and herbal products) and share||
0069|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
0069|100|I|the dosage of any medicines without your doctor's approval.||
0069|101|B|||
0069|102|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0069|103|O|has overdosed and has serious symptoms such as passing out or||
0069|104|O|trouble breathing, call 911. Otherwise, call a poison control||
0069|105|O|center right away. US residents can call 1-800-222-1222. Canada||
0069|106|O|residents can call 1-844-764-7669.||
0069|107|B|||
0069|108|N|NOTES:  Do not share this medication with others.||
0069|109|N|   Wear loose-fitting clothing over your herpes sores to keep||
0069|110|N|from irritating them.||
0069|111|N|   Cold sore outbreaks can be caused by many factors such as||
0069|112|N|stress, hormonal changes (such as pregnancy, menstrual period),||
0069|113|N|injury/surgery on the mouth (such as dental work), tiredness,||
0069|114|N|sunlight, cold weather, or fever/cold/flu. Talk to your doctor||
0069|115|N|about identifying and managing these triggers.||
0069|116|B|||
0069|117|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0069|118|D|If it is near the time of the next dose, skip the missed dose.||
0069|119|D|Use your next dose at the regular time. Do not double the dose to||
0069|120|D|catch up.||
0069|121|B|||
0069|122|R|STORAGE:  Store at room temperature. Keep all medications away||
0069|123|R|from children and pets.||
0069|124|R|   Do not flush medications down the toilet or pour them into a||
0069|125|R|drain unless instructed to do so. Properly discard this product||
0069|126|R|when it is expired or no longer needed. Consult your pharmacist||
0069|127|R|or local waste disposal company.||
0069|128|B|||
0069|129|A|Information last revised October 2024.||
0069|130|A|Copyright(c) 2025 First Databank, Inc.||
0069|131|B|||
0070|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0070|002|Z|does NOT have all possible information about this product. This||
0070|003|Z|information does not assure that this product is safe, effective,||
0070|004|Z|or appropriate for you. This information is not individual||
0070|005|Z|medical advice and does not substitute for the advice of your||
0070|006|Z|health care professional. Always ask your health care||
0070|007|Z|professional for complete information about this product and your||
0070|008|Z|specific health needs.||
0070|009|B|||
0070|010|T|QUINIDINE - ORAL||
0070|011|F|(KWIN-i-deen)||
0070|012|B|||
0070|013|C|COMMON BRAND NAME(S): Quinidex||
0070|014|B|||
0070|015|W|WARNING:  Before taking this drug for treatment of an irregular||
0070|016|W|heartbeat, you should discuss your risks and benefits of||
0070|017|W|treatment with your doctor or pharmacist. This drug should be||
0070|018|W|used only in carefully selected patients. Many heart drugs like||
0070|019|W|quinidine (antiarrhythmics) are very effective, but they can||
0070|020|W|rarely cause new serious (possibly fatal) irregular heartbeats.||
0070|021|B|||
0070|022|U|USES:  This medication is used to treat or prevent many types of||
0070|023|U|irregular heartbeats (heart arrhythmias such as atrial||
0070|024|U|fibrillation). Quinidine can greatly improve your ability to||
0070|025|U|perform normal activities by decreasing the number of irregular||
0070|026|U|heartbeats you have. However, it may not stop all your irregular||
0070|027|U|heartbeats completely. It works by blocking abnormal heartbeat||
0070|028|U|signals.||
0070|029|U|   Before and while you are using quinidine, your doctor may||
0070|030|U|prescribe other medications (such as "blood||
0070|031|U|thinners"/anticoagulants such as warfarin, beta blockers such as||
0070|032|U|metoprolol) to shrink any blood clots in the heart and to slow||
0070|033|U|your pulse.||
0070|034|B|||
0070|035|V|OTHER USES:  This section contains uses of this drug that are not||
0070|036|V|listed in the approved professional labeling for the drug but||
0070|037|V|that may be prescribed by your health care professional. Use this||
0070|038|V|drug for a condition that is listed in this section only if it||
0070|039|V|has been so prescribed by your health care professional.||
0070|040|V|   This drug may also be used for malaria.||
0070|041|B|||
0070|042|H|HOW TO USE:  Before starting this drug, the manufacturer||
0070|043|H|recommends that you take a test dose (usually a smaller amount||
0070|044|H|than your regular dose) to determine whether you are allergic to||
0070|045|H|it. Consult your doctor or pharmacist for details.||
0070|046|H|   Take this medication by mouth with or without food with a full||
0070|047|H|glass of liquid (8 ounces/240 milliliters) as directed by your||
0070|048|H|doctor. This medication is best taken on an empty stomach, but||
0070|049|H|taking it with food may help decrease stomach upset. Do not lie||
0070|050|H|down for at least 10 minutes after taking this medication.||
0070|051|H|   Do not crush or chew extended-release tablets. Doing so can||
0070|052|H|release all of the drug at once, increasing the risk of side||
0070|053|H|effects. Swallow the tablets whole.||
0070|054|H|   There are different brands and forms of this medication||
0070|055|H|available. Not all have identical effects. Do not change||
0070|056|H|quinidine products without talking to your doctor or pharmacist.||
0070|057|H|   The dosage is based on your medical condition and response to||
0070|058|H|treatment.||
0070|059|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0070|060|H|using this medication unless your doctor or pharmacist says you||
0070|061|H|may do so safely. Grapefruit can increase the chance of side||
0070|062|H|effects with this medicine. Ask your doctor or pharmacist for||
0070|063|H|more details.||
0070|064|H|   Avoid large changes in your dietary salt intake while being||
0070|065|H|treated with this medication unless your doctor instructs you||
0070|066|H|otherwise. The amount of salt in your diet may affect the amount||
0070|067|H|of quinidine absorbed by your system. Consult your doctor or||
0070|068|H|pharmacist for more details.||
0070|069|H|   Use this medication regularly to get the most benefit from it.||
0070|070|H|To help you remember, take it at the same time(s) each day.||
0070|071|H|   Tell your doctor if your condition does not get better or if||
0070|072|H|it gets worse.||
0070|073|B|||
0070|074|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, loss of appetite,||
0070|075|S|stomach pain/cramps, or a burning feeling in throat or chest||
0070|076|S|(such as heartburn) may occur. If any of these effects last or||
0070|077|S|get worse, tell your doctor or pharmacist promptly.||
0070|078|S|   Remember that this medication has been prescribed because your||
0070|079|S|doctor has judged that the benefit to you is greater than the||
0070|080|S|risk of side effects. Many people using this medication do not||
0070|081|S|have serious side effects.||
0070|082|S|   Tell your doctor right away if you have any serious side||
0070|083|S|effects, including: vision changes, eye pain, muscle pain, signs||
0070|084|S|of low blood sugar (such as unusual sweating, shakiness), signs||
0070|085|S|of infection (such as sore throat that doesn't go away, fever,||
0070|086|S|chills), easy bruising/bleeding, extreme tiredness, signs of||
0070|087|S|liver problems (such as nausea/vomiting that doesn't stop, dark||
0070|088|S|urine, yellowing eyes/skin), aching/swollen joints.||
0070|089|S|   Get medical help right away if you have any very serious side||
0070|090|S|effects, including: severe dizziness, fainting, sudden change in||
0070|091|S|heartbeat (faster/slower/more irregular).||
0070|092|S|   A very serious allergic reaction to this drug is rare.||
0070|093|S|However, get medical help right away if you notice any symptoms||
0070|094|S|of a serious allergic reaction, including: rash, itching/swelling||
0070|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0070|096|S|breathing.||
0070|097|S|   One type of reaction (cinchonism) can occur after even a||
0070|098|S|single dose of this drug. Contact your doctor of pharmacist||
0070|099|S|promptly if you notice symptoms such as ringing in the ears,||
0070|100|S|sudden hearing problems, headache, blurred vision, confusion.||
0070|101|S|Your dosage may need to be adjusted.||
0070|102|S|   Certain long-acting brands of quinidine may appear as a whole||
0070|103|S|tablet in the stool. This is the empty shell left after the||
0070|104|S|medicine has been absorbed by the body. It is harmless.||
0070|105|S|   This is not a complete list of possible side effects. If you||
0070|106|S|notice other effects not listed above, contact your doctor or||
0070|107|S|pharmacist.||
0070|108|S|   In the US -||
0070|109|S|   Call your doctor for medical advice about side effects. You||
0070|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0070|111|S|www.fda.gov/medwatch.||
0070|112|S|   In Canada - Call your doctor for medical advice about side||
0070|113|S|effects. You may report side effects to Health Canada at||
0070|114|S|1-866-234-2345.||
0070|115|B|||
0070|116|P|PRECAUTIONS:  Before taking quinidine, tell your doctor or||
0070|117|P|pharmacist if you are allergic to it; or to quinine; or if you||
0070|118|P|have any other allergies. This product may contain inactive||
0070|119|P|ingredients, which can cause allergic reactions or other||
0070|120|P|problems. Talk to your pharmacist for more details.||
0070|121|P|   Before using this medication, tell your doctor or pharmacist||
0070|122|P|your medical history, especially of: certain types of heart||
0070|123|P|disease (such as incomplete or complete heart block without an||
0070|124|P|artificial pacemaker, torsades-type irregular heartbeats,||
0070|125|P|digitalis toxicity), very low blood pressure, history of easy||
0070|126|P|bruising/bleeding (thrombocytopenic purpura) with use of quinine||
0070|127|P|or quinidine, severe muscle weakness (myasthenia gravis), kidney||
0070|128|P|disease, liver disease, a certain blood disorder (G6PD||
0070|129|P|deficiency), asthma, current infection with fever.||
0070|130|P|   Quinidine may cause a condition that affects the heart rhythm||
0070|131|P|(QT prolongation). QT prolongation can rarely cause serious||
0070|132|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0070|133|P|as severe dizziness, fainting) that require immediate medical||
0070|134|P|attention right away.||
0070|135|P|   The risk of QT prolongation may be increased if you have||
0070|136|P|certain medical conditions or are taking other drugs that may||
0070|137|P|cause QT prolongation. Before using quinidine, tell your doctor||
0070|138|P|or pharmacist of all the drugs you take and if you have any of||
0070|139|P|the following conditions: certain heart problems (heart failure,||
0070|140|P|slow heartbeat, QT prolongation in the EKG), family history of||
0070|141|P|certain heart problems (QT prolongation in the EKG, sudden||
0070|142|P|cardiac death).||
0070|143|P|   Low levels of potassium or magnesium in the blood may also||
0070|144|P|increase your risk of QT prolongation. This risk may increase if||
0070|145|P|you use certain drugs (such as diuretics/"water pills") or if you||
0070|146|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0070|147|P|Talk to your doctor about using quinidine safely.||
0070|148|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0070|149|P|can make you more dizzy. Do not drive, use machinery, or do||
0070|150|P|anything that needs alertness until you can do it safely. Limit||
0070|151|P|alcoholic beverages. Talk to your doctor if you are using||
0070|152|P|marijuana (cannabis).||
0070|153|P|   Before having surgery, tell your doctor or dentist about all||
0070|154|P|the products you use (including prescription drugs,||
0070|155|P|nonprescription drugs, and herbal products).||
0070|156|P|   Older adults may be more sensitive to the side effects of this||
0070|157|P|drug, especially dizziness and QT prolongation (see above).||
0070|158|P|   During pregnancy, this medication should be used only when||
0070|159|P|clearly needed. Discuss the risks and benefits with your doctor.||
0070|160|P|   This medication passes into breast milk. Consult your doctor||
0070|161|P|before breastfeeding.||
0070|162|B|||
0070|163|I|DRUG INTERACTIONS:  See also the How to Use section.||
0070|164|I|   Drug interactions may change how your medications work or||
0070|165|I|increase your risk for serious side effects. This document does||
0070|166|I|not contain all possible drug interactions. Keep a list of all||
0070|167|I|the products you use (including prescription/nonprescription||
0070|168|I|drugs and herbal products) and share it with your doctor and||
0070|169|I|pharmacist. Do not start, stop, or change the dosage of any||
0070|170|I|medicines without your doctor's approval.||
0070|171|I|   Some products that may interact with this drug include:||
0070|172|I|fingolimod, propafenone.||
0070|173|I|   Other medications can affect the removal of quinidine from||
0070|174|I|your body, which may affect how quinidine works. Examples include||
0070|175|I|cobicistat, mifepristone, ritonavir, certain azole antifungals||
0070|176|I|(including fluconazole, itraconazole, ketoconazole, posaconazole,||
0070|177|I|voriconazole), certain protease inhibitors (such as nelfinavir,||
0070|178|I|tipranavir), among others.||
0070|179|I|   This medication can slow down the removal of other medications||
0070|180|I|from your body, which may affect how they work. Examples of||
0070|181|I|affected drugs include aliskiren, codeine, digoxin, mefloquine,||
0070|182|I|tricyclic antidepressants (such as desipramine, imipramine),||
0070|183|I|among others.||
0070|184|I|   Many drugs besides quinidine may affect the heart rhythm (QT||
0070|185|I|prolongation), including artemether/lumefantrine, ranolazine,||
0070|186|I|toremifene, antiarrhythmic drugs (such as amiodarone,||
0070|187|I|disopyramide, dofetilide, dronedarone, ibutilide, procainamide,||
0070|188|I|sotalol), antipsychotics (such as pimozide, thioridazine,||
0070|189|I|ziprasidone), among others.||
0070|190|I|   Quinidine is very similar to quinine. Do not use medications||
0070|191|I|containing quinine while using quinidine.||
0070|192|B|||
0070|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0070|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0070|195|O|poison control center right away. US residents can call||
0070|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0070|197|O|Symptoms of overdose may include: severe dizziness/fainting,||
0070|198|O|hallucinations, seizures.||
0070|199|B|||
0070|200|N|NOTES:  Do not share this medication with others.||
0070|201|N|   Lab and/or medical tests (such as complete blood count,||
0070|202|N|liver/kidney function, quinidine blood levels, EKG) should be||
0070|203|N|done while you are taking this medication. Keep all medical and||
0070|204|N|lab appointments. Consult your doctor for more details.||
0070|205|B|||
0070|206|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0070|207|D|remember. If it is near the time of the next dose, skip the||
0070|208|D|missed dose. Take your next dose at the regular time. Do not||
0070|209|D|double the dose to catch up.||
0070|210|B|||
0070|211|R|STORAGE:  Store at room temperature away from light and moisture.||
0070|212|R|Do not store in the bathroom. Keep all medications away from||
0070|213|R|children and pets.||
0070|214|R|   Do not flush medications down the toilet or pour them into a||
0070|215|R|drain unless instructed to do so. Properly discard this product||
0070|216|R|when it is expired or no longer needed. Consult your pharmacist||
0070|217|R|or local waste disposal company.||
0070|218|B|||
0070|219|M|MEDICAL ALERT:  Your condition can cause complications in a||
0070|220|M|medical emergency. For information about enrolling in MedicAlert,||
0070|221|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0070|222|B|||
0070|223|A|Information last revised May 2025.||
0070|224|A|Copyright(c) 2025 First Databank, Inc.||
0070|225|B|||
0073|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0073|002|Z|does NOT have all possible information about this product. This||
0073|003|Z|information does not assure that this product is safe, effective,||
0073|004|Z|or appropriate for you. This information is not individual||
0073|005|Z|medical advice and does not substitute for the advice of your||
0073|006|Z|health care professional. Always ask your health care||
0073|007|Z|professional for complete information about this product and your||
0073|008|Z|specific health needs.||
0073|009|B|||
0073|010|T|TETRACYCLINE - ORAL||
0073|011|F|(TET-ra-SYE-kleen)||
0073|012|B|||
0073|013|C|COMMON BRAND NAME(S): Sumycin||
0073|014|B|||
0073|015|U|USES:  Tetracycline is used to treat a wide variety of||
0073|016|U|infections, including acne. It is an antibiotic that works by||
0073|017|U|stopping the growth of bacteria.||
0073|018|U|   This antibiotic treats only bacterial infections. It will not||
0073|019|U|work for viral infections (such as common cold, flu). Using any||
0073|020|U|antibiotic when it is not needed can cause it to not work for||
0073|021|U|future infections.||
0073|022|U|   Tetracycline can also be used in combination with anti-ulcer||
0073|023|U|medications to treat certain types of stomach ulcers.||
0073|024|B|||
0073|025|H|HOW TO USE:  Take this medication by mouth on an empty stomach||
0073|026|H|(at least 1 hour before or 2 hours after meals) as directed by||
0073|027|H|your doctor, usually 2 or 4 times daily. If stomach upset occurs,||
0073|028|H|ask your doctor if you can take this medication with food. Take||
0073|029|H|each dose with a full glass of water (8 ounces or 240||
0073|030|H|milliliters) unless your doctor directs you otherwise. Do not lie||
0073|031|H|down for at least 10 minutes after taking this medication. For||
0073|032|H|this reason, do not take it right before bedtime.||
0073|033|H|   Take this medication 2 to 3 hours before or after taking any||
0073|034|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
0073|035|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
0073|036|H|sucralfate, vitamins/minerals, dairy products (such as milk,||
0073|037|H|yogurt), and juice with added calcium. These products bind with||
0073|038|H|tetracycline, preventing your body from fully absorbing the drug.||
0073|039|H|   The dosage is based on your medical condition and response to||
0073|040|H|treatment. Children's dosage is also based on weight.||
0073|041|H|   For the best effect, take this antibiotic at evenly spaced||
0073|042|H|times. To help you remember, take this medication at the same||
0073|043|H|time(s) every day.||
0073|044|H|   Continue to take this medication until the full prescribed||
0073|045|H|amount is finished even if symptoms disappear after a few days.||
0073|046|H|Stopping the medication too early may result in a return of the||
0073|047|H|infection.||
0073|048|H|   Tell your doctor if your condition lasts or gets worse.||
0073|049|B|||
0073|050|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, loss of appetite,||
0073|051|S|mouth sores, black hairy tongue, sore throat, dizziness,||
0073|052|S|headache, or rectal discomfort may occur. If any of these effects||
0073|053|S|last or get worse, tell your doctor or pharmacist promptly.||
0073|054|S|   Remember that this medication has been prescribed because your||
0073|055|S|doctor has judged that the benefit to you is greater than the||
0073|056|S|risk of side effects. Many people using this medication do not||
0073|057|S|have serious side effects.||
0073|058|S|   Tell your doctor right away if you have any serious side||
0073|059|S|effects, including: nail discoloration, muscle pain, difficult or||
0073|060|S|painful swallowing, signs of kidney problems (such as change in||
0073|061|S|the amount of urine), brown/gray tooth discoloration,||
0073|062|S|numbness/tingling of the hands/feet, unusual tiredness, new signs||
0073|063|S|of infection (such as sore throat that doesn't go away, fever,||
0073|064|S|chills), hearing changes (such as ringing in the ears, decreased||
0073|065|S|hearing), easy bruising/bleeding, signs of liver disease (such as||
0073|066|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0073|067|S|   Tetracycline may rarely cause increased pressure around the||
0073|068|S|brain (intracranial hypertension-IH). The risk of this side||
0073|069|S|effect is greater for women of childbearing age who are||
0073|070|S|overweight or who have had IH in the past. If IH develops, it||
0073|071|S|usually goes away after tetracycline is stopped; however, there||
0073|072|S|is a chance of permanent vision loss or blindness. Get medical||
0073|073|S|help right away if you have: nausea/vomiting that doesn't stop,||
0073|074|S|headache that is severe or doesn't go away, vision changes (such||
0073|075|S|as blurred/double vision, decreased vision, sudden blindness).||
0073|076|S|   This medication may rarely cause a severe intestinal condition||
0073|077|S|due to a bacteria called C. difficile. This condition may occur||
0073|078|S|during treatment or weeks to months after treatment has stopped.||
0073|079|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0073|080|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0073|081|S|stool.||
0073|082|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0073|083|S|products because they may make symptoms worse.||
0073|084|S|   Use of this medication for prolonged or repeated periods may||
0073|085|S|result in oral thrush or a new yeast infection (oral or vaginal||
0073|086|S|fungal infection). Contact your doctor if you notice white||
0073|087|S|patches in your mouth, a change in vaginal discharge or other new||
0073|088|S|symptoms.||
0073|089|S|   A very serious allergic reaction to this drug is rare.||
0073|090|S|However, get medical help right away if you notice any symptoms||
0073|091|S|of a serious allergic reaction, including: rash, skin||
0073|092|S|lesions/sores, itching/swelling (especially of the||
0073|093|S|face/tongue/throat), severe dizziness, trouble breathing, new or||
0073|094|S|worsening swelling/pain in the joints, chest pain, fast/irregular||
0073|095|S|heartbeat.||
0073|096|S|   This is not a complete list of possible side effects. If you||
0073|097|S|notice other effects not listed above, contact your doctor or||
0073|098|S|pharmacist.||
0073|099|S|   In the US -||
0073|100|S|   Call your doctor for medical advice about side effects. You||
0073|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0073|102|S|www.fda.gov/medwatch.||
0073|103|S|   In Canada - Call your doctor for medical advice about side||
0073|104|S|effects. You may report side effects to Health Canada at||
0073|105|S|1-866-234-2345.||
0073|106|B|||
0073|107|P|PRECAUTIONS:  See also Side Effects section.||
0073|108|P|   Before taking tetracycline, tell your doctor or pharmacist if||
0073|109|P|you are allergic to it; or to other tetracyclines (such as||
0073|110|P|doxycycline, minocycline), or if you have any other allergies.||
0073|111|P|This product may contain inactive ingredients, which can cause||
0073|112|P|allergic reactions or other problems. Talk to your pharmacist for||
0073|113|P|more details.||
0073|114|P|   Before using this medication, tell your doctor or pharmacist||
0073|115|P|your medical history, especially of: kidney disease, liver||
0073|116|P|disease, problems swallowing, esophagus problems (such as hiatal||
0073|117|P|hernia, reflux disease-GERD).||
0073|118|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0073|119|P|can make you more dizzy. Do not drive, use machinery, or do||
0073|120|P|anything that needs alertness until you can do it safely. Limit||
0073|121|P|alcoholic beverages. Talk to your doctor if you are using||
0073|122|P|marijuana (cannabis).||
0073|123|P|   Tetracycline may cause live bacterial vaccines (such as||
0073|124|P|typhoid vaccine) to not work well. Tell your health care||
0073|125|P|professional that you are using tetracycline before having any||
0073|126|P|immunizations/vaccinations.||
0073|127|P|   This medication may make you more sensitive to the sun. Limit||
0073|128|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0073|129|P|sunscreen and wear protective clothing when outdoors. Tell your||
0073|130|P|doctor right away if you get sunburned or have skin||
0073|131|P|blisters/redness.||
0073|132|P|   Before having surgery, tell your doctor or dentist about all||
0073|133|P|the products you use (including prescription drugs,||
0073|134|P|nonprescription drugs, and herbal products).||
0073|135|P|   Older adults may be more sensitive to the side effects of this||
0073|136|P|drug.||
0073|137|P|   This medication should not be used by children younger than 8||
0073|138|P|years of age because it may cause permanent tooth discoloration||
0073|139|P|and other problems. Tooth discoloration has also occurred in||
0073|140|P|older children and young adults. Consult your doctor for more||
0073|141|P|information.||
0073|142|P|   Tell your doctor if you are pregnant or plan to become||
0073|143|P|pregnant. You should not become pregnant while using||
0073|144|P|tetracycline. Tetracycline may harm an unborn baby. If you become||
0073|145|P|pregnant, talk to your doctor right away about the risks and||
0073|146|P|benefits of this medication.||
0073|147|P|   This medication passes into breast milk. Consult your doctor||
0073|148|P|before breastfeeding.||
0073|149|B|||
0073|150|I|DRUG INTERACTIONS:  See also How to Use.||
0073|151|I|   Drug interactions may change how your medications work or||
0073|152|I|increase your risk for serious side effects. This document does||
0073|153|I|not contain all possible drug interactions. Keep a list of all||
0073|154|I|the products you use (including prescription/nonprescription||
0073|155|I|drugs and herbal products) and share it with your doctor and||
0073|156|I|pharmacist. Do not start, stop, or change the dosage of any||
0073|157|I|medicines without your doctor's approval.||
0073|158|I|   Some products that may interact with this drug include:||
0073|159|I|atovaquone, retinoid medications taken by mouth (such as||
0073|160|I|acitretin, isotretinoin), strontium, digoxin, kaolin pectin,||
0073|161|I|warfarin.||
0073|162|I|   This medication may interfere with certain lab tests, possibly||
0073|163|I|causing false test results. Make sure lab personnel and all your||
0073|164|I|doctors know you use this drug.||
0073|165|B|||
0073|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0073|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0073|168|O|poison control center right away. US residents can call||
0073|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0073|170|B|||
0073|171|N|NOTES:  Do not share this medication with others.||
0073|172|N|   This medication has been prescribed for your current condition||
0073|173|N|only. Do not use it later for another infection unless your||
0073|174|N|doctor tells you to.||
0073|175|N|   Lab and/or medical tests may be done while you are taking this||
0073|176|N|medication. Keep all medical and lab appointments. Consult your||
0073|177|N|doctor for more details.||
0073|178|B|||
0073|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0073|180|D|remember. If it is near the time of the next dose, skip the||
0073|181|D|missed dose. Take your next dose at the regular time. Do not||
0073|182|D|double the dose to catch up.||
0073|183|B|||
0073|184|R|STORAGE:  Store at room temperature away from light and moisture.||
0073|185|R|Do not store in the bathroom. Keep all medications away from||
0073|186|R|children and pets.||
0073|187|R|   Do not flush medications down the toilet or pour them into a||
0073|188|R|drain unless instructed to do so. Properly discard this product||
0073|189|R|when it is expired or no longer needed. Taking outdated||
0073|190|R|tetracycline can result in serious illness. Consult your||
0073|191|R|pharmacist or local waste disposal company.||
0073|192|B|||
0073|193|A|Information last revised September 2025.||
0073|194|A|Copyright(c) 2025 First Databank, Inc.||
0073|195|B|||
0074|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0074|002|Z|does NOT have all possible information about this product. This||
0074|003|Z|information does not assure that this product is safe, effective,||
0074|004|Z|or appropriate for you. This information is not individual||
0074|005|Z|medical advice and does not substitute for the advice of your||
0074|006|Z|health care professional. Always ask your health care||
0074|007|Z|professional for complete information about this product and your||
0074|008|Z|specific health needs.||
0074|009|B|||
0074|010|T|THYROID - ORAL||
0074|011|F|(THYE-royd)||
0074|012|B|||
0074|013|C|COMMON BRAND NAME(S): Adthyza, Armour Thyroid||
0074|014|B|||
0074|015|W|WARNING:  This medication should not be used for weight loss.||
0074|016|W|Normal doses of this medication will not work for weight loss,||
0074|017|W|and large doses of this medication may cause serious, possibly||
0074|018|W|fatal side effects, especially when taken with diet pills.||
0074|019|B|||
0074|020|U|USES:  Thyroid hormone is used to treat underactive thyroid||
0074|021|U|(hypothyroidism). It is a natural product made from animal||
0074|022|U|thyroid glands (usually a pig's). It replaces or provides more||
0074|023|U|thyroid hormone, which is normally produced by the thyroid gland.||
0074|024|U|Low thyroid hormone levels can occur naturally or when the||
0074|025|U|thyroid gland is injured by radiation/medications or removed by||
0074|026|U|surgery. Having enough thyroid hormone is important for||
0074|027|U|maintaining normal mental and physical activity. In children,||
0074|028|U|having enough thyroid hormone is important for normal mental and||
0074|029|U|physical development.||
0074|030|U|   This medication is also used to treat other types of thyroid||
0074|031|U|disorders (such as certain types of goiters, thyroid cancer) and||
0074|032|U|also to test for thyroid function.||
0074|033|U|   This medication should not be used to treat infertility unless||
0074|034|U|it is caused by low thyroid hormone levels.||
0074|035|U|   Older adults should discuss the risks and benefits of this||
0074|036|U|medication with their doctor or pharmacist.||
0074|037|B|||
0074|038|H|HOW TO USE:  Take this medication by mouth as directed by your||
0074|039|H|doctor, usually once daily on an empty stomach, 30 minutes to 1||
0074|040|H|hour before breakfast.||
0074|041|H|   The dosage is based on your medical condition, lab tests, and||
0074|042|H|response to treatment. Children's dosage is also based on age and||
0074|043|H|weight.||
0074|044|H|   Use this medication regularly in order to get the most benefit||
0074|045|H|from it. To help you remember, take it at the same time each day.||
0074|046|H|   Do not stop taking this medication without first consulting||
0074|047|H|with your doctor. Thyroid replacement treatment is usually taken||
0074|048|H|for life.||
0074|049|H|   Certain medications (cholestyramine, colestipol, colesevelam,||
0074|050|H|antacids, sucralfate, simethicone, iron, sodium polystyrene||
0074|051|H|sulfonate, calcium carbonate, orlistat) can decrease the amount||
0074|052|H|of thyroid hormone that is absorbed by your body. If you are||
0074|053|H|taking any of these drugs, separate them from this medication by||
0074|054|H|at least 4 hours.||
0074|055|H|   There are different brands of thyroid hormone available. Do||
0074|056|H|not change brands without first consulting your doctor or||
0074|057|H|pharmacist.||
0074|058|H|   Symptoms of low thyroid hormone levels include tiredness,||
0074|059|H|muscle aches, constipation, dry skin, weight gain, slow||
0074|060|H|heartbeat, or sensitivity to cold. Tell your doctor if your||
0074|061|H|condition gets worse or lasts after several weeks of taking this||
0074|062|H|medication.||
0074|063|B|||
0074|064|S|SIDE EFFECTS:  Hair loss may occur during the first few months of||
0074|065|S|treatment. This effect is usually temporary as your body adjusts||
0074|066|S|to this medication. If this effect lasts or gets worse, tell your||
0074|067|S|doctor or pharmacist promptly.||
0074|068|S|   Remember that this medication has been prescribed because your||
0074|069|S|doctor has judged that the benefit to you is greater than the||
0074|070|S|risk of side effects. Many people using this medication do not||
0074|071|S|have serious side effects.||
0074|072|S|   Tell your doctor right away if you have any serious side||
0074|073|S|effects of high thyroid hormone levels, including: increased||
0074|074|S|sweating, sensitivity to heat, mental/mood changes (such as||
0074|075|S|nervousness, mood swings), tiredness, diarrhea, shaking (tremor),||
0074|076|S|headache, shortness of breath.||
0074|077|S|   Get medical help right away if you have any very serious||
0074|078|S|effects of high thyroid hormone levels, including: chest pain,||
0074|079|S|fast/pounding/irregular heartbeat, swelling hands/ankles/feet,||
0074|080|S|seizures.||
0074|081|S|   A very serious allergic reaction to this drug is rare.||
0074|082|S|However, get medical help right away if you notice any symptoms||
0074|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0074|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0074|085|S|breathing.||
0074|086|S|   This is not a complete list of possible side effects. If you||
0074|087|S|notice other effects not listed above, contact your doctor or||
0074|088|S|pharmacist.||
0074|089|S|   In the US -||
0074|090|S|   Call your doctor for medical advice about side effects. You||
0074|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0074|092|S|www.fda.gov/medwatch.||
0074|093|S|   In Canada - Call your doctor for medical advice about side||
0074|094|S|effects. You may report side effects to Health Canada at||
0074|095|S|1-866-234-2345.||
0074|096|B|||
0074|097|P|PRECAUTIONS:  Before taking thyroid hormone, tell your doctor or||
0074|098|P|pharmacist if you are allergic to it; or to pork products; or if||
0074|099|P|you have any other allergies. This product may contain inactive||
0074|100|P|ingredients, which can cause allergic reactions or other||
0074|101|P|problems. Talk to your pharmacist for more details.||
0074|102|P|   Before using this medication, tell your doctor or pharmacist||
0074|103|P|your medical history, especially of: increased thyroid hormones||
0074|104|P|(thyrotoxicosis), decreased adrenal gland function, heart disease||
0074|105|P|(such as coronary artery disease, irregular heartbeat), high||
0074|106|P|blood pressure, diabetes.||
0074|107|P|   Before having surgery, tell your doctor or dentist about all||
0074|108|P|the products you use (including prescription drugs,||
0074|109|P|nonprescription drugs, and herbal products).||
0074|110|P|   Older adults may be more sensitive to the side effects of this||
0074|111|P|drug, especially chest pain, fast/pounding/irregular heartbeat.||
0074|112|P|   Current information shows that this drug may be used during||
0074|113|P|pregnancy. Tell your doctor if you are pregnant because your dose||
0074|114|P|may need to be adjusted.||
0074|115|P|   Thyroid hormone passes into breast milk but is unlikely to||
0074|116|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0074|117|B|||
0074|118|I|DRUG INTERACTIONS:  See also How to Use Section.||
0074|119|I|   Drug interactions may change how your medications work or||
0074|120|I|increase your risk for serious side effects. This document does||
0074|121|I|not contain all possible drug interactions. Keep a list of all||
0074|122|I|the products you use (including prescription/nonprescription||
0074|123|I|drugs and herbal products) and share it with your doctor and||
0074|124|I|pharmacist. Do not start, stop, or change the dosage of any||
0074|125|I|medicines without your doctor's approval.||
0074|126|B|||
0074|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0074|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0074|129|O|poison control center right away. US residents can call||
0074|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0074|131|O|Symptoms of overdose may include: fast/pounding/irregular||
0074|132|O|heartbeat, loss of consciousness, confusion, seizures.||
0074|133|B|||
0074|134|N|NOTES:  Do not share this medication with others.||
0074|135|N|   Lab and/or medical tests (such as thyroid function) should be||
0074|136|N|done while you are taking this medication. Keep all medical and||
0074|137|N|lab appointments. Consult your doctor for more details.||
0074|138|B|||
0074|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0074|140|D|remember. If it is near the time of the next dose, skip the||
0074|141|D|missed dose. Take your next dose at the regular time. Do not||
0074|142|D|double the dose to catch up unless your doctor tells you to do||
0074|143|D|so. Call your doctor if you miss 2 or more doses in a row. Ask||
0074|144|D|your doctor ahead of time what to do about a missed dose and||
0074|145|D|follow your doctor's specific directions.||
0074|146|B|||
0074|147|R|STORAGE:  Store at room temperature away from light and moisture.||
0074|148|R|Do not store in the bathroom. Keep all medications away from||
0074|149|R|children and pets.||
0074|150|R|   Do not flush medications down the toilet or pour them into a||
0074|151|R|drain unless instructed to do so. Properly discard this product||
0074|152|R|when it is expired or no longer needed. Consult your pharmacist||
0074|153|R|or local waste disposal company.||
0074|154|B|||
0074|155|A|Information last revised August 2024.||
0074|156|A|Copyright(c) 2025 First Databank, Inc.||
0074|157|B|||
0075|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0075|002|Z|does NOT have all possible information about this product. This||
0075|003|Z|information does not assure that this product is safe, effective,||
0075|004|Z|or appropriate for you. This information is not individual||
0075|005|Z|medical advice and does not substitute for the advice of your||
0075|006|Z|health care professional. Always ask your health care||
0075|007|Z|professional for complete information about this product and your||
0075|008|Z|specific health needs.||
0075|009|B|||
0075|010|T|CILAZAPRIL - ORAL||
0075|011|F|(sye-LAZ-a-pril)||
0075|012|B|||
0075|013|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
0075|014|W|unborn baby if used during pregnancy. It is important to prevent||
0075|015|W|pregnancy while taking this medication. Consult your doctor for||
0075|016|W|more details and to discuss the use of reliable forms of birth||
0075|017|W|control while taking this medication. If you are planning||
0075|018|W|pregnancy, become pregnant, or think you may be pregnant, contact||
0075|019|W|your doctor right away.||
0075|020|B|||
0075|021|U|USES:  This medication is used alone or with other medications to||
0075|022|U|treat high blood pressure. Lowering high blood pressure helps||
0075|023|U|prevent strokes, heart attacks, and kidney problems. It is also||
0075|024|U|used with other drugs to treat heart failure.||
0075|025|U|   Cilazapril belongs to a group of drugs called ACE inhibitors.||
0075|026|U|It works by relaxing the blood vessels so that blood can flow||
0075|027|U|through the body more easily.||
0075|028|B|||
0075|029|V|OTHER USES:  This section contains uses of this drug that are not||
0075|030|V|listed in the approved professional labeling for the drug but||
0075|031|V|that may be prescribed by your health care professional. Use this||
0075|032|V|drug for a condition that is listed in this section only if it||
0075|033|V|has been so prescribed by your health care professional.||
0075|034|V|   This medication may also be used for kidney disease and to||
0075|035|V|help protect the kidneys from harm due to diabetes.||
0075|036|B|||
0075|037|H|HOW TO USE:  Take this medication by mouth with or without food||
0075|038|H|as directed by your doctor, usually once or twice daily.||
0075|039|H|   The dosage is based on your medical condition and response to||
0075|040|H|treatment.||
0075|041|H|   Use this medication regularly in order to get the most benefit||
0075|042|H|from it. To help you remember, take it at the same time(s) each||
0075|043|H|day.||
0075|044|H|   Keep taking this medication even if you feel well. Most people||
0075|045|H|with high blood pressure do not feel sick.||
0075|046|H|   For the treatment of high blood pressure, it may take 2 weeks||
0075|047|H|before the full benefit of this drug takes effect.||
0075|048|H|   Tell your doctor if your condition does not get better or if||
0075|049|H|it gets worse (for example, your blood pressure readings remain||
0075|050|H|high or increase).||
0075|051|B|||
0075|052|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
0075|053|S|body adjusts to the medication. Nausea or dry cough may also||
0075|054|S|occur. If any of these effects last or get worse, notify your||
0075|055|S|doctor or pharmacist promptly.||
0075|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
0075|057|S|slowly when rising from a sitting or lying position.||
0075|058|S|   Remember that this medication has been prescribed because your||
0075|059|S|doctor has judged that the benefit to you is greater than the||
0075|060|S|risk of side effects. Many people using this medication do not||
0075|061|S|have serious side effects.||
0075|062|S|   Tell your doctor right away if you have any serious side||
0075|063|S|effects, including: fast/irregular heartbeat, swelling of the||
0075|064|S|hands/feet, mental/mood changes, numbness/tingling of the||
0075|065|S|hands/feet, muscle/joint aches, fainting, decreased sexual||
0075|066|S|ability/interest, easy bruising/bleeding, symptoms of a high||
0075|067|S|potassium blood level (such as muscle weakness, slow/irregular||
0075|068|S|heartbeat).||
0075|069|S|   Although cilazapril may be used to prevent kidney problems or||
0075|070|S|treat people who have kidney problems, it may also rarely cause||
0075|071|S|serious kidney problems or make them worse. Your doctor will||
0075|072|S|check your kidney function while you are taking cilazapril. Tell||
0075|073|S|your doctor right away if you have any signs of kidney problems||
0075|074|S|such as a change in the amount of urine.||
0075|075|S|   This drug may rarely cause serious (possibly fatal) liver||
0075|076|S|problems. Get medical help right away if you have any symptoms of||
0075|077|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0075|078|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0075|079|S|urine.||
0075|080|S|   A very serious allergic reaction to this drug is rare.||
0075|081|S|However, get medical help right away if you notice any symptoms||
0075|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0075|083|S|(especially of the face/tongue/throat/neck), severe dizziness,||
0075|084|S|trouble breathing.||
0075|085|S|   This is not a complete list of possible side effects. If you||
0075|086|S|notice other effects not listed above, contact your doctor or||
0075|087|S|pharmacist.||
0075|088|S|   In the US -||
0075|089|S|   Call your doctor for medical advice about side effects. You||
0075|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0075|091|S|www.fda.gov/medwatch.||
0075|092|S|   In Canada - Call your doctor for medical advice about side||
0075|093|S|effects. You may report side effects to Health Canada at||
0075|094|S|1-866-234-2345.||
0075|095|B|||
0075|096|P|PRECAUTIONS:  Before taking cilazapril, tell your doctor or||
0075|097|P|pharmacist if you are allergic it; or to other ACE inhibitors||
0075|098|P|(such as captopril, lisinopril); or if you have any other||
0075|099|P|allergies. This product may contain inactive ingredients, which||
0075|100|P|can cause allergic reactions or other problems. Talk to your||
0075|101|P|pharmacist for more details.||
0075|102|P|   Before using this medication, tell your doctor or pharmacist||
0075|103|P|your medical history, especially of: a history of an allergic||
0075|104|P|reaction that included swelling of the face/lips/tongue/throat||
0075|105|P|(angioedema), fluid/swelling of the stomach/abdomen (ascites),||
0075|106|P|blood exchange procedures (such as apheresis, dialysis),||
0075|107|P|dehydration, untreated salt imbalances (such as high potassium,||
0075|108|P|low sodium), liver disease.||
0075|109|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0075|110|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0075|111|P|machinery, or do anything that needs alertness until you can do||
0075|112|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0075|113|P|are using marijuana (cannabis).||
0075|114|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0075|115|P|and cause you to feel lightheaded. Tell your doctor if you have||
0075|116|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0075|117|P|of fluids unless your doctor tells you not to.||
0075|118|P|   Before having surgery, tell your doctor or dentist about all||
0075|119|P|the products you use (including prescription drugs,||
0075|120|P|nonprescription drugs, and herbal products).||
0075|121|P|   This drug may increase your potassium levels. Before using||
0075|122|P|potassium supplements or salt substitutes containing potassium,||
0075|123|P|consult your doctor or pharmacist.||
0075|124|P|   Older adults may be more sensitive to the side effects of this||
0075|125|P|drug, including dizziness and increases in potassium level.||
0075|126|P|   Tell your doctor if you are pregnant or plan to become||
0075|127|P|pregnant. You should not become pregnant while using cilazapril .||
0075|128|P|Cilazapril may harm an unborn baby. If you become pregnant, talk||
0075|129|P|to your doctor right away about the risks and benefits of this||
0075|130|P|medication. (See also Warning section.)||
0075|131|P|   This drug may pass into breast milk and could have undesirable||
0075|132|P|effects on a nursing infant. Breastfeeding is not recommended||
0075|133|P|while using this drug. Consult your doctor before breastfeeding.||
0075|134|B|||
0075|135|I|DRUG INTERACTIONS:  See also Precautions section.||
0075|136|I|   Drug interactions may change how your medications work or||
0075|137|I|increase your risk for serious side effects. This document does||
0075|138|I|not contain all possible drug interactions. Keep a list of all||
0075|139|I|the products you use (including prescription/nonprescription||
0075|140|I|drugs and herbal products) and share it with your doctor and||
0075|141|I|pharmacist. Do not start, stop, or change the dosage of any||
0075|142|I|medicines without your doctor's approval.||
0075|143|I|   Some products that may interact with this drug are: aliskiren,||
0075|144|I|alpha blockers (such as prazosin, terazosin), drugs that may||
0075|145|I|increase the level of potassium in the blood (such as ARBs||
0075|146|I|including losartan/valsartan, birth control pills containing||
0075|147|I|drospirenone), certain drugs that weaken the immune||
0075|148|I|system/increase the risk of infection (such as everolimus,||
0075|149|I|sirolimus), lithium, gold injections, sacubitril.||
0075|150|I|   A very serious reaction may occur if you are getting||
0075|151|I|injections for bee/wasp sting allergy (desensitization) and are||
0075|152|I|also taking cilazapril. Make sure all your doctors know which||
0075|153|I|medicines you are using.||
0075|154|I|   Some products have ingredients that could raise your blood||
0075|155|I|pressure. Tell your pharmacist what products you are using, and||
0075|156|I|ask how to use them safely (especially cough-and-cold products,||
0075|157|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0075|158|B|||
0075|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0075|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0075|161|O|poison control center right away. US residents can call||
0075|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0075|163|O|Symptoms of overdose may include: severe dizziness.||
0075|164|B|||
0075|165|N|NOTES:  Do not share this medication with others. Lifestyle||
0075|166|N|changes such as stress reduction programs, exercise, and dietary||
0075|167|N|changes may increase the effectiveness of this medicine. Talk to||
0075|168|N|your doctor or pharmacist about lifestyle changes that might||
0075|169|N|benefit you.||
0075|170|N|   Lab and/or medical tests (such as complete blood count, blood||
0075|171|N|sodium and potassium levels, kidney/liver function) should be||
0075|172|N|done while you are taking this medication. Keep all medical and||
0075|173|N|lab appointments. Consult your doctor for more details.||
0075|174|N|   Check your blood pressure regularly while taking this||
0075|175|N|medication, especially when you first start this drug or when||
0075|176|N|your dose is changed. Learn how to monitor your own blood||
0075|177|N|pressure at home, and share the results with your doctor.||
0075|178|B|||
0075|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0075|180|D|remember. If it is near the time of the next dose, skip the||
0075|181|D|missed dose. Take your next dose at the regular time. Do not||
0075|182|D|double the dose to catch up.||
0075|183|B|||
0075|184|R|STORAGE:  Store at room temperature away from light and moisture.||
0075|185|R|Do not store in the bathroom. Keep all medications away from||
0075|186|R|children and pets.||
0075|187|R|   Do not flush medications down the toilet or pour them into a||
0075|188|R|drain unless instructed to do so. Properly discard this product||
0075|189|R|when it is expired or no longer needed. Consult your pharmacist||
0075|190|R|or local waste disposal company.||
0075|191|B|||
0075|192|A|Information last revised May 2024.||
0075|193|A|Copyright(c) 2025 First Databank, Inc.||
0075|194|B|||
0077|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0077|002|Z|does NOT have all possible information about this product. This||
0077|003|Z|information does not assure that this product is safe, effective,||
0077|004|Z|or appropriate for you. This information is not individual||
0077|005|Z|medical advice and does not substitute for the advice of your||
0077|006|Z|health care professional. Always ask your health care||
0077|007|Z|professional for complete information about this product and your||
0077|008|Z|specific health needs.||
0077|009|B|||
0077|010|T|NICOTINE GUM - BUCCAL||
0077|011|F|(NIK-oh-teen)||
0077|012|B|||
0077|013|C|COMMON BRAND NAME(S): Nicorette||
0077|014|B|||
0077|015|U|USES:  This medication can help you quit smoking by replacing the||
0077|016|U|nicotine in cigarettes. The nicotine in tobacco is an important||
0077|017|U|part of cigarette addiction. When you stop smoking, your nicotine||
0077|018|U|levels drop quickly. This drop can cause withdrawal symptoms such||
0077|019|U|as craving tobacco, nervousness, irritability, headache, weight||
0077|020|U|gain, and difficulty concentrating.||
0077|021|U|   Stopping smoking is hard and your chance of success is best||
0077|022|U|when you are ready and have made a commitment to quit. Nicotine||
0077|023|U|replacement products are part of a total stop-smoking program||
0077|024|U|that includes behavior change, counseling, and support. Smoking||
0077|025|U|causes lung disease, cancer, and heart disease. Stopping smoking||
0077|026|U|is one of the most important things you can do to improve your||
0077|027|U|health and live longer.||
0077|028|B|||
0077|029|H|HOW TO USE:  If you are using the over-the-counter product, read||
0077|030|H|all directions on the product package before using this||
0077|031|H|medication. If your doctor has prescribed this medication, read||
0077|032|H|the Patient Information Leaflet if available from your pharmacist||
0077|033|H|before you start using this product and each time you get a||
0077|034|H|refill. If you have any questions, ask your doctor or pharmacist.||
0077|035|H|   Do not eat or drink anything for 15 minutes before or during||
0077|036|H|use of the gum. Do not use if the individual wrapper is open or||
0077|037|H|damaged.||
0077|038|H|   Start this medication on your quit (smoking) day. Chew a piece||
0077|039|H|of gum when you feel the urge to smoke. Chew the gum very slowly||
0077|040|H|until it tingles, then move it to the space between your cheek||
0077|041|H|and gum. Keep it there until it stops tingling. When the tingle||
0077|042|H|is gone, begin chewing again until the tingle returns. Most of||
0077|043|H|the nicotine will be gone after 30 minutes. Do not use more than||
0077|044|H|1 piece of gum at a time. You may also use this product on a||
0077|045|H|regular schedule as well as at times when you have the urge to||
0077|046|H|smoke. The best dose for you is the dose that decreases the urge||
0077|047|H|to smoke without side effects from too much nicotine. Your dose||
0077|048|H|will need to be adjusted to your needs, including your smoking||
0077|049|H|history and medical condition.||
0077|050|H|   For the first 6 weeks, use at least 9 pieces each day. If you||
0077|051|H|still have a strong urge to smoke, you can use a second piece of||
0077|052|H|gum within 1 hour. Do not continuously use 1 piece right after||
0077|053|H|another. Doing so will increase side effects such as hiccups,||
0077|054|H|nausea, or heartburn. Most people use about 9 to 12 pieces of gum||
0077|055|H|per day during the first month of treatment. Do not chew more||
0077|056|H|than 24 pieces of gum a day.||
0077|057|H|   After you have stopped smoking and you have reached the best||
0077|058|H|dose and schedule for you, continue at that dose. Start to lower||
0077|059|H|your dose after 6 weeks or as directed by your doctor until you||
0077|060|H|are no longer smoking and no longer need nicotine replacement. It||
0077|061|H|is important to complete the treatment with this medication (12||
0077|062|H|weeks). If after the treatment period, you still feel the need to||
0077|063|H|use this medication to prevent you from smoking, talk to your||
0077|064|H|doctor.||
0077|065|H|   If you suddenly stop using this medication, you may have||
0077|066|H|withdrawal symptoms (such as tobacco cravings, nervousness,||
0077|067|H|irritability, headache). To help prevent withdrawal, your doctor||
0077|068|H|may lower your dose slowly. Withdrawal is more likely if you have||
0077|069|H|used nicotine for a long time or in high doses. Tell your doctor||
0077|070|H|or pharmacist right away if you have withdrawal.||
0077|071|H|   Some smokers are unsuccessful the first time they try to quit.||
0077|072|H|You may need to stop using this product and try again later. Many||
0077|073|H|people who cannot quit the first time are successful the next||
0077|074|H|time.||
0077|075|B|||
0077|076|S|SIDE EFFECTS:  Mouth/teeth/jaw problems, headache, heartburn,||
0077|077|S|sweating, or diarrhea may occur. If any of these side effects||
0077|078|S|last or get worse, stop using this medication and tell your||
0077|079|S|doctor or pharmacist promptly.||
0077|080|S|   Common nicotine withdrawal symptoms can occur when you stop||
0077|081|S|smoking and include dizziness, anxiety, depression, or trouble||
0077|082|S|sleeping, among others.||
0077|083|S|   Chewing the gum too fast can cause lightheadedness, dizziness,||
0077|084|S|hiccups, nausea, vomiting, or trouble sleeping. If these effects||
0077|085|S|occur, chew the gum more slowly.||
0077|086|S|   If your doctor has directed you to use this medication,||
0077|087|S|remember that your doctor has judged that the benefit to you is||
0077|088|S|greater than the risk of side effects. Many people using this||
0077|089|S|medication do not have serious side effects.||
0077|090|S|   Serious side effects are more likely if you continue to smoke||
0077|091|S|while using this product.||
0077|092|S|   Stop using this medication and tell your doctor right away if||
0077|093|S|you have any serious side effects, including: severe dizziness,||
0077|094|S|mental/mood changes (such as irritability, trouble sleeping,||
0077|095|S|vivid dreams), numbness/tingling in hands/feet, swelling||
0077|096|S|hands/ankles/feet.||
0077|097|S|   Stop using this medication and get medical help right away if||
0077|098|S|you have any very serious side effects, including: chest pain,||
0077|099|S|confusion, severe headache, fast/irregular/pounding heartbeat,||
0077|100|S|trouble speaking, weakness on one side of the body.||
0077|101|S|   A very serious allergic reaction to this drug is rare.||
0077|102|S|However, get medical help right away if you notice any symptoms||
0077|103|S|of a serious allergic reaction, including: rash, itching/swelling||
0077|104|S|(especially of the face/tongue/throat), trouble breathing.||
0077|105|S|   This is not a complete list of possible side effects. If you||
0077|106|S|notice other effects not listed above, contact your doctor or||
0077|107|S|pharmacist.||
0077|108|S|   In the US -||
0077|109|S|   Call your doctor for medical advice about side effects. You||
0077|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0077|111|S|www.fda.gov/medwatch.||
0077|112|S|   In Canada - Call your doctor for medical advice about side||
0077|113|S|effects. You may report side effects to Health Canada at||
0077|114|S|1-866-234-2345.||
0077|115|B|||
0077|116|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0077|117|P|pharmacist if you are allergic to nicotine; or if you have any||
0077|118|P|other allergies. This product may contain inactive ingredients,||
0077|119|P|which can cause allergic reactions or other problems. Talk to||
0077|120|P|your pharmacist for more details.||
0077|121|P|   Before using this medication, tell your doctor or pharmacist||
0077|122|P|your medical history, especially of: blood vessel disease (such||
0077|123|P|as Raynaud's disease, stroke), dental/jaw problems (such as||
0077|124|P|bridges, temporal mandibular joint disease-TMJ), diabetes, heart||
0077|125|P|disease (such as chest pain, heart attack, irregular heartbeat),||
0077|126|P|high blood pressure, liver disease, kidney disease, esophagus||
0077|127|P|problems (such as esophagitis), stomach/intestinal sores (peptic||
0077|128|P|ulcers), a certain adrenal gland tumor (pheochromocytoma),||
0077|129|P|overactive thyroid (hyperthyroidism), seizures.||
0077|130|P|   Before having surgery, tell your doctor or dentist about all||
0077|131|P|the products you use (including prescription drugs,||
0077|132|P|nonprescription drugs, and herbal products).||
0077|133|P|   Nicotine and smoking may harm an unborn baby. If you are||
0077|134|P|pregnant, try to stop smoking without using a nicotine||
0077|135|P|replacement product if possible. During pregnancy, this||
0077|136|P|medication should be used only when clearly needed. Discuss the||
0077|137|P|risks and benefits with your doctor.||
0077|138|P|   Nicotine from smoking and from this medication passes into||
0077|139|P|breast milk and could have undesirable effects on a nursing||
0077|140|P|infant. Smoking near an infant can also harm the infant. Consult||
0077|141|P|your doctor before breastfeeding.||
0077|142|B|||
0077|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0077|144|I|medications work or increase your risk for serious side effects.||
0077|145|I|This document does not contain all possible drug interactions.||
0077|146|I|Keep a list of all the products you use (including||
0077|147|I|prescription/nonprescription drugs and herbal products) and share||
0077|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
0077|149|I|the dosage of any medicines without your doctor's approval.||
0077|150|I|   Stopping smoking can change the way the liver removes certain||
0077|151|I|drugs from the body (such as acetaminophen, caffeine, insulin,||
0077|152|I|oxazepam, pentazocine, propoxyphene, propranolol, theophylline,||
0077|153|I|tricyclic antidepressants such as amitriptyline/imipramine,||
0077|154|I|"water pills"/diuretics such as furosemide). Tell all your||
0077|155|I|doctors and pharmacists that you are quitting smoking.||
0077|156|B|||
0077|157|O|OVERDOSE:  This product may be harmful if swallowed. If someone||
0077|158|O|has overdosed and has serious symptoms such as passing out or||
0077|159|O|trouble breathing, call 911. Otherwise, call a poison control||
0077|160|O|center right away. US residents can call 1-800-222-1222. Canada||
0077|161|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0077|162|O|include: confusion, drooling, seizure, slow/shallow breathing,||
0077|163|O|hearing problems.||
0077|164|B|||
0077|165|N|NOTES:  Do not share this medication with others.||
0077|166|B|||
0077|167|D|MISSED DOSE:  If you are using this on a regular schedule and you||
0077|168|D|miss a dose, use it as soon as you remember. If it is near the||
0077|169|D|time of the next dose, skip the missed dose. Use your next dose||
0077|170|D|at the regular time. Do not double the dose to catch up.||
0077|171|B|||
0077|172|R|STORAGE:  Store at room temperature away from light and moisture.||
0077|173|R|Do not store in the bathroom. Wrap the used piece of gum in a||
0077|174|R|piece of paper and discard in the trash away from children and||
0077|175|R|pets. Keep all medications away from children and pets.||
0077|176|R|   Do not flush medications down the toilet or pour them into a||
0077|177|R|drain unless instructed to do so. Properly discard this product||
0077|178|R|when it is expired or no longer needed. Consult your pharmacist||
0077|179|R|or local waste disposal company.||
0077|180|B|||
0077|181|A|Information last revised August 2024.||
0077|182|A|Copyright(c) 2025 First Databank, Inc.||
0077|183|B|||
0078|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0078|002|Z|does NOT have all possible information about this product. This||
0078|003|Z|information does not assure that this product is safe, effective,||
0078|004|Z|or appropriate for you. This information is not individual||
0078|005|Z|medical advice and does not substitute for the advice of your||
0078|006|Z|health care professional. Always ask your health care||
0078|007|Z|professional for complete information about this product and your||
0078|008|Z|specific health needs.||
0078|009|B|||
0078|010|T|TRIAMTERENE - ORAL||
0078|011|F|(trye-AM-ter-een)||
0078|012|B|||
0078|013|C|COMMON BRAND NAME(S): Dyrenium||
0078|014|B|||
0078|015|W|WARNING:  This medication can increase your potassium levels,||
0078|016|W|especially if you have kidney disease or diabetes, or are||
0078|017|W|severely ill. Potassium levels must be done while you are taking||
0078|018|W|this medication. If not treated, very high potassium levels can||
0078|019|W|sometimes be fatal. If you notice any of the following serious||
0078|020|W|side effects, tell your doctor right away: muscle weakness,||
0078|021|W|slow/irregular heartbeat.||
0078|022|B|||
0078|023|U|USES:  Triamterene is a "water pill" (diuretic) that works in||
0078|024|U|your kidneys to increase the amount of urine you make. This helps||
0078|025|U|your body get rid of extra water. This medication is used to||
0078|026|U|decrease swelling (edema) caused by conditions such as cancer,||
0078|027|U|heart failure, liver disease, and kidney disease. This effect can||
0078|028|U|help your kidneys work better and lessen symptoms such as trouble||
0078|029|U|breathing and swelling in your ankles, feet, hands, or belly.||
0078|030|B|||
0078|031|V|OTHER USES:  This section contains uses of this drug that are not||
0078|032|V|listed in the approved professional labeling for the drug but||
0078|033|V|that may be prescribed by your health care professional. Use this||
0078|034|V|drug for a condition that is listed in this section only if it||
0078|035|V|has been so prescribed by your health care professional.||
0078|036|V|   This drug may also be used for high blood pressure.||
0078|037|B|||
0078|038|H|HOW TO USE:  Take this medication by mouth as directed by your||
0078|039|H|doctor, usually once or twice a day after a meal. If you take||
0078|040|H|this drug too close to bedtime, you may need to wake up to||
0078|041|H|urinate. It is best to take this medication at least 4 hours||
0078|042|H|before your bedtime.||
0078|043|H|   To reduce your risk of side effects, your doctor may direct||
0078|044|H|you to start this medication at a low dose and gradually increase||
0078|045|H|your dose. Follow your doctor's instructions carefully.||
0078|046|H|   The dosage is based on your medical condition and response to||
0078|047|H|treatment.||
0078|048|H|   Use this medication regularly to get the most benefit from it.||
0078|049|H|To help you remember, take it at the same time(s) each day.||
0078|050|H|   Do not increase your dose or use this drug more often or for||
0078|051|H|longer than prescribed. Your condition will not improve any||
0078|052|H|faster, and your risk of side effects will increase.||
0078|053|H|   Do not stop taking this medication without consulting your||
0078|054|H|doctor. Some conditions may become worse when this drug is||
0078|055|H|suddenly stopped. Your dose may need to be gradually decreased.||
0078|056|H|   Tell your doctor if you do not get better or if you get worse.||
0078|057|B|||
0078|058|S|SIDE EFFECTS:  See also Warning section.||
0078|059|S|   Dizziness, lightheadedness, tiredness, headache, stomach||
0078|060|S|upset, or diarrhea may occur. If any of these effects last or get||
0078|061|S|worse, tell your doctor or pharmacist promptly.||
0078|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
0078|063|S|slowly when rising from a sitting or lying position.||
0078|064|S|   Remember that this medication has been prescribed because your||
0078|065|S|doctor has judged that the benefit to you is greater than the||
0078|066|S|risk of side effects. Many people using this medication do not||
0078|067|S|have serious side effects.||
0078|068|S|   This medication may cause dehydration and electrolyte||
0078|069|S|imbalance. Tell your doctor right away if you have any symptoms||
0078|070|S|of dehydration or electrolyte imbalance, including unusual dry||
0078|071|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0078|072|S|heartbeat, or confusion.||
0078|073|S|   Tell your doctor right away if you have any serious side||
0078|074|S|effects, including: signs of kidney problems (such as pain in the||
0078|075|S|side/back/abdomen, painful urination, blood in the urine, change||
0078|076|S|in the amount of urine), joint pain (such as big toe pain),||
0078|077|S|fainting.||
0078|078|S|   A very serious allergic reaction to this drug is rare.||
0078|079|S|However, get medical help right away if you notice any symptoms||
0078|080|S|of a serious allergic reaction, including: rash, itching/swelling||
0078|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0078|082|S|breathing.||
0078|083|S|   This is not a complete list of possible side effects. If you||
0078|084|S|notice other effects not listed above, contact your doctor or||
0078|085|S|pharmacist.||
0078|086|S|   In the US -||
0078|087|S|   Call your doctor for medical advice about side effects. You||
0078|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0078|089|S|www.fda.gov/medwatch.||
0078|090|S|   In Canada - Call your doctor for medical advice about side||
0078|091|S|effects. You may report side effects to Health Canada at||
0078|092|S|1-866-234-2345.||
0078|093|B|||
0078|094|P|PRECAUTIONS:  See also Warning section.||
0078|095|P|   Before using this medication, tell your doctor or pharmacist||
0078|096|P|your medical history, especially of: kidney problems (such as||
0078|097|P|kidney stones), liver disease, mineral imbalance (such as high||
0078|098|P|potassium blood level, low sodium blood level), dehydration,||
0078|099|P|gout, conditions causing low folic acid blood levels (such as||
0078|100|P|alcoholic cirrhosis, pregnancy).||
0078|101|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0078|102|P|can make you more dizzy. Do not drive, use machinery, or do||
0078|103|P|anything that needs alertness until you can do it safely. Limit||
0078|104|P|alcoholic beverages. Talk to your doctor if you are using||
0078|105|P|marijuana (cannabis).||
0078|106|P|   If you have diabetes, triamterene may affect your blood sugar.||
0078|107|P|Check your blood sugar regularly as directed and share the||
0078|108|P|results with your doctor. Tell your doctor right away if you have||
0078|109|P|symptoms of high blood sugar such as increased thirst/urination.||
0078|110|P|Your doctor may need to adjust your diabetes medication, exercise||
0078|111|P|program, or diet.||
0078|112|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0078|113|P|and cause you to feel lightheaded. Tell your doctor if you have||
0078|114|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0078|115|P|of fluids unless your doctor tells you not to.||
0078|116|P|   This medication may increase your potassium levels. Before||
0078|117|P|using potassium supplements or salt substitutes that contain||
0078|118|P|potassium, consult your doctor or pharmacist.||
0078|119|P|   This medication may make you more sensitive to the sun. Limit||
0078|120|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0078|121|P|sunscreen and wear protective clothing when outdoors. Tell your||
0078|122|P|doctor right away if you get sunburned or have skin||
0078|123|P|blisters/redness.||
0078|124|P|   Before having surgery, tell your doctor or dentist about all||
0078|125|P|the products you use (including prescription drugs,||
0078|126|P|nonprescription drugs, and herbal products).||
0078|127|P|   Older adults may be more sensitive to the side effects of this||
0078|128|P|drug, especially high potassium blood levels.||
0078|129|P|   During pregnancy, this medication should be used only when||
0078|130|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0078|131|P|benefits with your doctor.||
0078|132|P|   This drug may pass into breast milk. Consult your doctor||
0078|133|P|before breastfeeding.||
0078|134|B|||
0078|135|I|DRUG INTERACTIONS:  See also Precautions section.||
0078|136|I|   Drug interactions may change how your medications work or||
0078|137|I|increase your risk for serious side effects. This document does||
0078|138|I|not contain all possible drug interactions. Keep a list of all||
0078|139|I|the products you use (including prescription/nonprescription||
0078|140|I|drugs and herbal products) and share it with your doctor and||
0078|141|I|pharmacist. Do not start, stop, or change the dosage of any||
0078|142|I|medicines without your doctor's approval.||
0078|143|I|   Some products that may interact with this drug include: drugs||
0078|144|I|that may increase the level of potassium in the blood (such as||
0078|145|I|amiloride, cyclosporine, eplerenone, tacrolimus, birth control||
0078|146|I|pills containing drospirenone), lithium.||
0078|147|I|   Some products have ingredients that could raise your blood||
0078|148|I|pressure or worsen your swelling. Tell your pharmacist what||
0078|149|I|products you are using, and ask how to use them safely||
0078|150|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0078|151|I|ibuprofen/naproxen).||
0078|152|I|   This medication may interfere with certain lab tests, possibly||
0078|153|I|causing false test results. Make sure lab personnel and all your||
0078|154|I|doctors know you use this drug.||
0078|155|B|||
0078|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0078|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0078|158|O|poison control center right away. US residents can call||
0078|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0078|160|O|Symptoms of overdose may include: severe dizziness, muscle||
0078|161|O|weakness, slow/irregular heartbeat.||
0078|162|B|||
0078|163|N|NOTES:  Do not share this medication with others.||
0078|164|N|   Lab and/or medical tests (such as potassium levels,||
0078|165|N|kidney/liver function) should be done while you are taking this||
0078|166|N|medication. Keep all medical and lab appointments.||
0078|167|B|||
0078|168|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0078|169|D|remember. If it is near the time of the next dose, skip the||
0078|170|D|missed dose. Take your next dose at the regular time. Do not||
0078|171|D|double the dose to catch up.||
0078|172|B|||
0078|173|R|STORAGE:  Store at room temperature away from light and moisture.||
0078|174|R|Do not store in the bathroom. Keep all medications away from||
0078|175|R|children and pets.||
0078|176|R|   Do not flush medications down the toilet or pour them into a||
0078|177|R|drain unless instructed to do so. Properly discard this product||
0078|178|R|when it is expired or no longer needed. Consult your pharmacist||
0078|179|R|or local waste disposal company.||
0078|180|B|||
0078|181|A|Information last revised May 2024.||
0078|182|A|Copyright(c) 2025 First Databank, Inc.||
0078|183|B|||
0080|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0080|002|Z|does NOT have all possible information about this product. This||
0080|003|Z|information does not assure that this product is safe, effective,||
0080|004|Z|or appropriate for you. This information is not individual||
0080|005|Z|medical advice and does not substitute for the advice of your||
0080|006|Z|health care professional. Always ask your health care||
0080|007|Z|professional for complete information about this product and your||
0080|008|Z|specific health needs.||
0080|009|B|||
0080|010|T|DIETHYLPROPION - ORAL||
0080|011|F|(dye-ETH-il-PROE-pee-on)||
0080|012|B|||
0080|013|C|COMMON BRAND NAME(S): Tenuate||
0080|014|B|||
0080|015|U|USES:  Diethylpropion is used along with a doctor-approved,||
0080|016|U|reduced-calorie diet, exercise, and behavior change program to||
0080|017|U|help you lose weight. It is used in people who are significantly||
0080|018|U|overweight (obese) and have not been able to lose enough weight||
0080|019|U|with diet and exercise alone. Losing weight and keeping it off||
0080|020|U|can reduce the many health risks that come with obesity,||
0080|021|U|including heart disease, diabetes, high blood pressure, and a||
0080|022|U|shorter life.||
0080|023|U|   It is not known how this medication helps people to lose||
0080|024|U|weight. It may work by decreasing your appetite, increasing the||
0080|025|U|amount of energy used by your body, or by affecting certain parts||
0080|026|U|of the brain. This medication is an appetite suppressant and||
0080|027|U|belongs to a class of drugs called sympathomimetic amines.||
0080|028|B|||
0080|029|H|HOW TO USE:  Take the immediate-release form of this medication||
0080|030|H|by mouth as directed by your doctor, usually 3 times a day (1||
0080|031|H|hour before meals). If late-night eating is a problem, your||
0080|032|H|doctor may direct you to take another dose in the evening. Taking||
0080|033|H|this medication late in the day may cause trouble sleeping||
0080|034|H|(insomnia).||
0080|035|H|   The extended-release form of diethylpropion is usually taken||
0080|036|H|once a day in the mid-morning. Do not crush or chew||
0080|037|H|extended-release tablets. Doing so can release all of the drug at||
0080|038|H|once, increasing the risk of side effects. Swallow the tablets||
0080|039|H|whole.||
0080|040|H|   The dosage is based on your medical condition and response to||
0080|041|H|treatment. Your doctor will adjust the dose to find the best dose||
0080|042|H|for you. Use this medication regularly and exactly as prescribed||
0080|043|H|in order to get the most benefit from it. To help you remember,||
0080|044|H|take it at the same time(s) each day.||
0080|045|H|   Diethylpropion is usually taken for only a few weeks at a||
0080|046|H|time. It should not be taken with other appetite suppressants||
0080|047|H|(see also Drug Interaction section). The possibility of serious||
0080|048|H|side effects increases with longer use of this medication and use||
0080|049|H|of this drug along with certain other diet drugs.||
0080|050|H|   Caffeine can increase the side effects of this medication.||
0080|051|H|Avoid drinking large amounts of beverages containing caffeine||
0080|052|H|(coffee, tea, colas), eating large amounts of chocolate, or||
0080|053|H|taking nonprescription products that contain caffeine.||
0080|054|H|   If you suddenly stop using this medication, you may have||
0080|055|H|withdrawal symptoms (such as depression, severe tiredness). To||
0080|056|H|help prevent withdrawal, your doctor may lower your dose slowly.||
0080|057|H|Withdrawal is more likely if you have used diethylpropion for a||
0080|058|H|long time or in high doses. Tell your doctor or pharmacist right||
0080|059|H|away if you have withdrawal.||
0080|060|H|   Though it helps many people, this medication may sometimes||
0080|061|H|cause addiction. This risk may be higher if you have a substance||
0080|062|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0080|063|H|Do not increase your dose, take it more often, or use it for a||
0080|064|H|longer time than prescribed. Properly stop the medication when so||
0080|065|H|directed.||
0080|066|H|   You should see some weight loss soon after you start this||
0080|067|H|medication. Tell your doctor if you do not see at least 4 pounds||
0080|068|H|of weight loss within 4 weeks of starting this medication. This||
0080|069|H|medication may stop working well after you have been taking it||
0080|070|H|for a while. Talk with your doctor if this medication stops||
0080|071|H|working well. Do not increase the dose unless directed by your||
0080|072|H|doctor. Your doctor may direct you to stop taking this||
0080|073|H|medication.||
0080|074|B|||
0080|075|S|SIDE EFFECTS:  Dizziness, dry mouth, difficulty sleeping,||
0080|076|S|irritability, nausea, vomiting, diarrhea, or constipation may||
0080|077|S|occur. If these effects last or get worse, tell your doctor or||
0080|078|S|pharmacist promptly.||
0080|079|S|   Remember that this medication has been prescribed because your||
0080|080|S|doctor has judged that the benefit to you is greater than the||
0080|081|S|risk of side effects. Many people using this medication do not||
0080|082|S|have serious side effects.||
0080|083|S|   This medication may raise your blood pressure. Check your||
0080|084|S|blood pressure regularly and tell your doctor if the results are||
0080|085|S|high.||
0080|086|S|   Tell your doctor right away if you have any serious side||
0080|087|S|effects, including: fast/irregular/pounding heartbeat,||
0080|088|S|mental/mood changes (such as agitation, uncontrolled anger,||
0080|089|S|hallucinations, nervousness), uncontrolled muscle movements,||
0080|090|S|change in sexual ability/interest.||
0080|091|S|   Get medical help right away if you have any very serious side||
0080|092|S|effects, including: severe headache, trouble speaking, seizure,||
0080|093|S|weakness on one side of the body, vision changes (such as blurred||
0080|094|S|vision).||
0080|095|S|   This drug may rarely cause serious (sometimes fatal) lung or||
0080|096|S|heart problems (pulmonary hypertension, heart valve problems).||
0080|097|S|The risk increases with longer use of this medication and use of||
0080|098|S|this drug along with other appetite-suppressant drugs/herbal||
0080|099|S|products. If you notice any of the following serious side||
0080|100|S|effects, stop taking this medication and consult your doctor or||
0080|101|S|pharmacist right away: chest pain, difficulty breathing with||
0080|102|S|exercise, decreased ability to exercise, fainting, swelling of||
0080|103|S|the legs/ankles/feet.||
0080|104|S|   A very serious allergic reaction to this drug is rare.||
0080|105|S|However, get medical help right away if you notice any symptoms||
0080|106|S|of a serious allergic reaction, including: rash, itching/swelling||
0080|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0080|108|S|breathing.||
0080|109|S|   This is not a complete list of possible side effects. If you||
0080|110|S|notice other effects not listed above, contact your doctor or||
0080|111|S|pharmacist.||
0080|112|S|   In the US -||
0080|113|S|   Call your doctor for medical advice about side effects. You||
0080|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0080|115|S|www.fda.gov/medwatch.||
0080|116|S|   In Canada - Call your doctor for medical advice about side||
0080|117|S|effects. You may report side effects to Health Canada at||
0080|118|S|1-866-234-2345.||
0080|119|B|||
0080|120|P|PRECAUTIONS:  Before taking diethylpropion, tell your doctor or||
0080|121|P|pharmacist if you are allergic to it; or to any other||
0080|122|P|sympathomimetic amines (for example, decongestants such as||
0080|123|P|pseudoephedrine, stimulants such as amphetamine, appetite||
0080|124|P|suppressants such as phentermine); or if you have any other||
0080|125|P|allergies. This product may contain inactive ingredients, which||
0080|126|P|can cause allergic reactions or other problems. Talk to your||
0080|127|P|pharmacist for more details.||
0080|128|P|   Before using this medication, tell your doctor or pharmacist||
0080|129|P|your medical history, especially of: diabetes, glaucoma, high||
0080|130|P|blood pressure, high blood pressure in the lungs (pulmonary||
0080|131|P|hypertension), heart problems (such as fast/irregular heartbeat,||
0080|132|P|heart valve problems, previous heart attack), kidney disease,||
0080|133|P|mental/mood problems (such as anxiety, bipolar disorder,||
0080|134|P|psychosis, schizophrenia), seizure, stroke, overactive thyroid||
0080|135|P|(hyperthyroidism), personal or family history of a substance use||
0080|136|P|disorder (such as overuse of or addiction to drugs/alcohol).||
0080|137|P|   This drug may make you dizzy or blur your vision. It may also||
0080|138|P|rarely make you drowsy. Alcohol or marijuana (cannabis) can make||
0080|139|P|you more dizzy or drowsy. Do not drive, use machinery, or do||
0080|140|P|anything that needs alertness or clear vision until you can do it||
0080|141|P|safely. Avoid alcoholic beverages. Talk to your doctor if you are||
0080|142|P|using marijuana (cannabis).||
0080|143|P|   If you have diabetes, check your blood sugar regularly as||
0080|144|P|directed and share the results with your doctor. Your doctor may||
0080|145|P|need to adjust your diabetes medication during treatment with||
0080|146|P|this drug.||
0080|147|P|   Before having surgery, tell your doctor or dentist about all||
0080|148|P|the products you use (including prescription drugs,||
0080|149|P|nonprescription drugs, and herbal products).||
0080|150|P|   Older adults may be at greater risk for dizziness and high||
0080|151|P|blood pressure while using this drug.||
0080|152|P|   During pregnancy, this medication should be used only when||
0080|153|P|clearly needed. It is not recommended for use for long periods or||
0080|154|P|in high doses near the expected delivery date because of possible||
0080|155|P|harm to the unborn baby. Discuss the risks and benefits with your||
0080|156|P|doctor. Infants born to mothers who have been using this||
0080|157|P|medication for a long time or in high doses may have withdrawal||
0080|158|P|symptoms such as irritability or extreme tiredness. Tell your||
0080|159|P|doctor right away if you notice any of these symptoms in your||
0080|160|P|newborn.||
0080|161|P|   This drug may pass into breast milk and could have undesirable||
0080|162|P|effects on a nursing infant. Breastfeeding is not recommended||
0080|163|P|while using this drug. Consult your doctor before breastfeeding.||
0080|164|B|||
0080|165|I|DRUG INTERACTIONS:  See also How to Use section.||
0080|166|I|   Drug interactions may change how your medications work or||
0080|167|I|increase your risk for serious side effects. This document does||
0080|168|I|not contain all possible drug interactions. Keep a list of all||
0080|169|I|the products you use (including prescription/nonprescription||
0080|170|I|drugs and herbal products) and share it with your doctor and||
0080|171|I|pharmacist. Do not start, stop, or change the dosage of any||
0080|172|I|medicines without your doctor's approval.||
0080|173|I|   Some products that may interact with this drug are: stimulants||
0080|174|I|(for example, amphetamines, methylphenidate, street drugs such as||
0080|175|I|cocaine or MDMA/"ecstasy").||
0080|176|I|   This drug should not be used with certain medications because||
0080|177|I|very serious interactions may occur. If you are taking or have||
0080|178|I|taken other appetite-suppressant drugs in the past year (such as||
0080|179|I|phentermine, ephedra/ma huang), tell your doctor or pharmacist||
0080|180|I|before starting this medication.||
0080|181|I|   Taking MAO inhibitors with this medication may cause a serious||
0080|182|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0080|183|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0080|184|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0080|185|I|selegiline, tranylcypromine) during treatment with this||
0080|186|I|medication. Most MAO inhibitors should also not be taken for two||
0080|187|I|weeks before treatment with this medication. Ask your doctor when||
0080|188|I|to start or stop taking this medication.||
0080|189|I|   Tell your doctor or pharmacist if you are taking other||
0080|190|I|products that cause drowsiness such as opioid pain or cough||
0080|191|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0080|192|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0080|193|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0080|194|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0080|195|I|diphenhydramine).||
0080|196|I|   Check the labels on all your medicines (such as allergy or||
0080|197|I|cough-and-cold products) because they may contain ingredients||
0080|198|I|that cause drowsiness. Ask your pharmacist about using those||
0080|199|I|products safely.||
0080|200|I|   Some products have ingredients that could raise your heart||
0080|201|I|rate or blood pressure. Tell your pharmacist what products you||
0080|202|I|are using, and ask how to use them safely (especially||
0080|203|I|cough-and-cold products or diet aids).||
0080|204|B|||
0080|205|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0080|206|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0080|207|O|poison control center right away. US residents can call||
0080|208|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0080|209|O|Symptoms of overdose may include: rapid breathing, unusual||
0080|210|O|restlessness, fast/slow/irregular heartbeat, chest pain,||
0080|211|O|hallucinations, seizures, loss of consciousness.||
0080|212|B|||
0080|213|N|NOTES:  Appetite suppressants should not be used in place of||
0080|214|N|proper diet. For best results, this drug must be used along with||
0080|215|N|a doctor-approved diet and exercise program.||
0080|216|N|   Do not share this medication with others. Sharing it is||
0080|217|N|against the law.||
0080|218|N|   Lab and/or medical tests (such as blood pressure, heart/kidney||
0080|219|N|function) may be done while you are taking this medication. Keep||
0080|220|N|all medical and lab appointments. Consult your doctor for more||
0080|221|N|details.||
0080|222|B|||
0080|223|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0080|224|D|remember. If it is near the time of the next dose or late in the||
0080|225|D|evening, skip the missed dose. Take your next dose at the regular||
0080|226|D|time. Do not double the dose to catch up.||
0080|227|B|||
0080|228|R|STORAGE:  Store at room temperature away from light and moisture.||
0080|229|R|Do not store in the bathroom. Keep all medications away from||
0080|230|R|children and pets.||
0080|231|R|   Do not flush medications down the toilet or pour them into a||
0080|232|R|drain unless instructed to do so. Properly discard this product||
0080|233|R|when it is expired or no longer needed. Consult your pharmacist||
0080|234|R|or local waste disposal company.||
0080|235|B|||
0080|236|A|Information last revised July 2025.||
0080|237|A|Copyright(c) 2025 First Databank, Inc.||
0080|238|B|||
0082|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0082|002|Z|does NOT have all possible information about this product. This||
0082|003|Z|information does not assure that this product is safe, effective,||
0082|004|Z|or appropriate for you. This information is not individual||
0082|005|Z|medical advice and does not substitute for the advice of your||
0082|006|Z|health care professional. Always ask your health care||
0082|007|Z|professional for complete information about this product and your||
0082|008|Z|specific health needs.||
0082|009|B|||
0082|010|T|PRIMIDONE - ORAL||
0082|011|F|(PRIM-i-done)||
0082|012|B|||
0082|013|C|COMMON BRAND NAME(S): Mysoline||
0082|014|B|||
0082|015|U|USES:  This medication is used alone or with other medications to||
0082|016|U|control seizures. Controlling and reducing seizures lets you do||
0082|017|U|more of your normal daily activities, reduces your risk of harm||
0082|018|U|when you lose consciousness, and lessens your risk for a possibly||
0082|019|U|life-threatening condition of frequent, repeated seizures.||
0082|020|U|Primidone belongs to a class of drugs known as barbiturate||
0082|021|U|anticonvulsants. It works by controlling the abnormal electrical||
0082|022|U|activity in the brain that occurs during a seizure.||
0082|023|B|||
0082|024|H|HOW TO USE:  Read the Medication Guide provided by your||
0082|025|H|pharmacist before you start using primidone and each time you get||
0082|026|H|a refill. If you have any questions, ask your doctor or||
0082|027|H|pharmacist.||
0082|028|H|   Take this medication by mouth with or without food as directed||
0082|029|H|by your doctor, usually 3 to 4 times daily. Take with food or||
0082|030|H|milk if stomach upset occurs. Your doctor may direct you to start||
0082|031|H|this medication at a low dose at bedtime and gradually increase||
0082|032|H|your dose to prevent side effects such as drowsiness and||
0082|033|H|dizziness. If you are changing from a different anticonvulsant to||
0082|034|H|primidone, your doctor may direct you to continue your old||
0082|035|H|medication and slowly lower the dose as you begin taking||
0082|036|H|primidone. Follow your doctor's instructions carefully.||
0082|037|H|   The dosage is based on your medical condition, age, weight,||
0082|038|H|lab tests, and response to treatment. It may take several weeks||
0082|039|H|to reach the best dose for you.||
0082|040|H|   This medication works best when the amount of drug in your||
0082|041|H|body is kept at a constant level. Take this drug at evenly spaced||
0082|042|H|intervals. To help you remember, take it at the same times each||
0082|043|H|day.||
0082|044|H|   Do not stop taking this medication (and other anticonvulsant||
0082|045|H|medications) without consulting your doctor. Your seizures may||
0082|046|H|worsen or cause a very severe seizure that is difficult to treat||
0082|047|H|(status epilepticus) when this drug is suddenly stopped.||
0082|048|H|   If you suddenly stop using this medication, you may have||
0082|049|H|withdrawal symptoms (such as anxiety, hallucinations, twitching,||
0082|050|H|trouble sleeping). Withdrawal from primidone can be severe and||
0082|051|H|include seizures and (rarely) death. To help prevent withdrawal,||
0082|052|H|your doctor may lower your dose slowly. Withdrawal is more likely||
0082|053|H|if you have used primidone for a long time or in high doses. Tell||
0082|054|H|your doctor or pharmacist right away if you have withdrawal.||
0082|055|H|   Though it helps many people, this medication may sometimes||
0082|056|H|cause addiction. This risk may be higher if you have a substance||
0082|057|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0082|058|H|Take this medication exactly as prescribed to lower the risk of||
0082|059|H|addiction. Ask your doctor or pharmacist for more details.||
0082|060|H|   Tell your doctor if your seizure control gets worse (such as||
0082|061|H|the number of seizures increases).||
0082|062|B|||
0082|063|S|SIDE EFFECTS:  Dizziness, drowsiness, excitation, tiredness,||
0082|064|S|headache, loss of appetite, nausea, or vomiting may occur as your||
0082|065|S|body adjusts to the medication. If any of these effects last or||
0082|066|S|get worse, notify your doctor or pharmacist promptly.||
0082|067|S|   Remember that this medication has been prescribed because your||
0082|068|S|doctor has judged that the benefit to you is greater than the||
0082|069|S|risk of side effects. Many people using this medication do not||
0082|070|S|have serious side effects.||
0082|071|S|   Tell your doctor right away if you have any serious side||
0082|072|S|effects, including: staggering walk/clumsiness, decreased sexual||
0082|073|S|ability/interest, double vision, easy bruising/bleeding,||
0082|074|S|fainting, slow heartbeat, severe tiredness/weakness, pale skin,||
0082|075|S|fast/slow/shallow breathing.||
0082|076|S|   A small number of people who take anticonvulsants for any||
0082|077|S|condition (such as seizure, bipolar disorder, pain) may||
0082|078|S|experience depression, suicidal thoughts/attempts, or other||
0082|079|S|mental/mood problems. Tell your doctor right away if you or your||
0082|080|S|family/caregiver notice any unusual/sudden changes in your mood,||
0082|081|S|thoughts, or behavior including signs of depression, suicidal||
0082|082|S|thoughts/attempts, thoughts about harming yourself.||
0082|083|S|   A very serious allergic reaction to this drug is rare.||
0082|084|S|However, get medical help right away if you notice any symptoms||
0082|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0082|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0082|087|S|breathing.||
0082|088|S|   This is not a complete list of possible side effects. If you||
0082|089|S|notice other effects not listed above, contact your doctor or||
0082|090|S|pharmacist.||
0082|091|S|   In the US -||
0082|092|S|   Call your doctor for medical advice about side effects. You||
0082|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0082|094|S|www.fda.gov/medwatch.||
0082|095|S|   In Canada - Call your doctor for medical advice about side||
0082|096|S|effects. You may report side effects to Health Canada at||
0082|097|S|1-866-234-2345.||
0082|098|B|||
0082|099|P|PRECAUTIONS:  Before taking primidone, tell your doctor or||
0082|100|P|pharmacist if you are allergic to it; or to other barbiturates||
0082|101|P|(such as phenobarbital); or to other anti-seizure medications||
0082|102|P|(such as carbamazepine, fosphenytoin, oxcarbazepine, phenytoin);||
0082|103|P|or if you have any other allergies. This product may contain||
0082|104|P|inactive ingredients, which can cause allergic reactions or other||
0082|105|P|problems. Talk to your pharmacist for more details.||
0082|106|P|   Before using this medication, tell your doctor or pharmacist||
0082|107|P|your medical history, especially of: certain hormone problems||
0082|108|P|(adrenal disease such as Addison's disease), kidney problems,||
0082|109|P|liver problems, lung disease (such as sleep apnea, chronic||
0082|110|P|obstructive pulmonary disease-COPD), mental/mood disorders (such||
0082|111|P|as depression, thoughts of suicide), personal or family history||
0082|112|P|of a substance use disorder (such as overuse of or addiction to||
0082|113|P|drugs/alcohol), personal/family history of a certain blood||
0082|114|P|disorder (porphyria), certain vitamin deficiencies (folic acid,||
0082|115|P|vitamin K).||
0082|116|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0082|117|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0082|118|P|machinery, or do anything that needs alertness until you can do||
0082|119|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0082|120|P|are using marijuana (cannabis).||
0082|121|P|   Before having surgery, tell your doctor or dentist about all||
0082|122|P|the products you use (including prescription drugs,||
0082|123|P|nonprescription drugs, and herbal products).||
0082|124|P|   Older adults may be more sensitive to the effects of this||
0082|125|P|drug, especially drowsiness and dizziness. However, this drug can||
0082|126|P|often cause excitement or confusion instead of drowsiness in||
0082|127|P|older adults.||
0082|128|P|   Children may be more sensitive to the side effects of the||
0082|129|P|drug. This drug can often cause excitement instead of drowsiness||
0082|130|P|in young children.||
0082|131|P|   During pregnancy, this medication should be used only when||
0082|132|P|clearly needed. It may harm an unborn baby. Newborn babies of||
0082|133|P|mothers who use this medication late in pregnancy may have||
0082|134|P|symptoms such as slow/shallow breathing, nonstop crying, shaking,||
0082|135|P|or trouble feeding. However, since untreated seizures are a||
0082|136|P|serious condition that can harm both a pregnant woman and her||
0082|137|P|unborn baby, do not stop taking this medication unless directed||
0082|138|P|by your doctor. If you are planning pregnancy, become pregnant,||
0082|139|P|or think you may be pregnant, discuss with your doctor right away||
0082|140|P|the benefits and risks of using this medication during pregnancy.||
0082|141|P|Since birth control pills, patches, implants, and injections may||
0082|142|P|not work if taken with this medication (see also Drug||
0082|143|P|Interactions section), discuss reliable forms of birth control||
0082|144|P|with your doctor.||
0082|145|P|   This medication passes into breast milk and may cause||
0082|146|P|excessive sleepiness or feeding problems in the nursing infant.||
0082|147|P|Consult your doctor before breastfeeding.||
0082|148|B|||
0082|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0082|150|I|medications work or increase your risk for serious side effects.||
0082|151|I|This document does not contain all possible drug interactions.||
0082|152|I|Keep a list of all the products you use (including||
0082|153|I|prescription/nonprescription drugs and herbal products) and share||
0082|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
0082|155|I|the dosage of any medicines without your doctor's approval.||
0082|156|I|   Some products that may interact with this drug include:||
0082|157|I|darunavir, orlistat.||
0082|158|I|   Other medications can affect the removal of primidone from||
0082|159|I|your body, which may affect how primidone works. Examples include||
0082|160|I|St. John's wort, among others.||
0082|161|I|   This medication can speed up the removal of other medications||
0082|162|I|from your body, which may affect how they work. Examples of||
0082|163|I|affected drugs include artemether/lumefantrine, atazanavir,||
0082|164|I|cobicistat, etravirine, lurasidone, ranolazine, rilpivirine,||
0082|165|I|sofosbuvir, sorafenib, voriconazole, certain calcium channel||
0082|166|I|blockers (such as felodipine/nimodipine), among others.||
0082|167|I|   This medication may decrease the effectiveness of hormonal||
0082|168|I|birth control such as pills, patch, or ring. This could cause||
0082|169|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0082|170|I|use reliable backup birth control methods while using this||
0082|171|I|medication. Also tell your doctor if you have any new spotting or||
0082|172|I|breakthrough bleeding, because these may be signs that your birth||
0082|173|I|control is not working well.||
0082|174|I|   The risk of serious side effects (such as slow/shallow||
0082|175|I|breathing, severe drowsiness/dizziness) may be increased if this||
0082|176|I|medication is taken with other products that may also cause||
0082|177|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0082|178|I|if you are taking other products such as opioid pain or cough||
0082|179|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0082|180|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0082|181|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0082|182|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0082|183|I|diphenhydramine).||
0082|184|I|   Check the labels on all your medicines (such as allergy or||
0082|185|I|cough-and-cold products) because they may contain ingredients||
0082|186|I|that cause drowsiness. Ask your pharmacist about using those||
0082|187|I|products safely.||
0082|188|I|   Primidone is very similar to phenobarbital. Do not use||
0082|189|I|medications containing phenobarbital while using primidone.||
0082|190|B|||
0082|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0082|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0082|193|O|poison control center right away. US residents can call||
0082|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0082|195|O|Symptoms of overdose may include: severe tiredness/dizziness,||
0082|196|O|inability to wake up, very slow breathing rate.||
0082|197|B|||
0082|198|N|NOTES:  Do not share this medication with others.||
0082|199|N|   Lab and/or medical tests (such as primidone blood levels,||
0082|200|N|blood counts, liver/kidney function) should be done while you are||
0082|201|N|taking this medication. Keep all medical and lab appointments.||
0082|202|N|Consult your doctor for more details.||
0082|203|B|||
0082|204|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0082|205|D|remember. If it is near the time of the next dose, skip the||
0082|206|D|missed dose. Take your next dose at the regular time. Do not||
0082|207|D|double the dose to catch up.||
0082|208|B|||
0082|209|R|STORAGE:  Store at room temperature away from light and moisture.||
0082|210|R|Do not store in the bathroom. Keep all medications away from||
0082|211|R|children and pets.||
0082|212|R|   Do not flush medications down the toilet or pour them into a||
0082|213|R|drain unless instructed to do so. Properly discard this product||
0082|214|R|when it is expired or no longer needed. Consult your pharmacist||
0082|215|R|or local waste disposal company.||
0082|216|B|||
0082|217|M|MEDICAL ALERT:  Your condition can cause complications in a||
0082|218|M|medical emergency. For information about enrolling in MedicAlert,||
0082|219|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0082|220|B|||
0082|221|A|Information last revised March 2025.||
0082|222|A|Copyright(c) 2025 First Databank, Inc.||
0082|223|B|||
0084|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0084|002|Z|does NOT have all possible information about this product. This||
0084|003|Z|information does not assure that this product is safe, effective,||
0084|004|Z|or appropriate for you. This information is not individual||
0084|005|Z|medical advice and does not substitute for the advice of your||
0084|006|Z|health care professional. Always ask your health care||
0084|007|Z|professional for complete information about this product and your||
0084|008|Z|specific health needs.||
0084|009|B|||
0084|010|T|DIPYRIDAMOLE - ORAL||
0084|011|F|(DYE-pir-ID-a-mole)||
0084|012|B|||
0084|013|C|COMMON BRAND NAME(S): Persantine||
0084|014|B|||
0084|015|U|USES:  This medication is used in combination with "blood||
0084|016|U|thinners" such as warfarin to keep clots from forming after heart||
0084|017|U|valve replacements. Clots are a serious complication that can||
0084|018|U|cause strokes, heart attacks, or blocked blood vessels in the||
0084|019|U|lungs (pulmonary embolisms). Dipyridamole is an antiplatelet||
0084|020|U|drug. It helps to keep blood flowing by stopping platelets from||
0084|021|U|clumping together and by keeping heart blood vessels open.||
0084|022|B|||
0084|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
0084|024|H|doctor, usually 4 times daily.||
0084|025|H|   The dosage is based on your medical condition and response to||
0084|026|H|treatment.||
0084|027|H|   Use this medication regularly to get the most benefit from it.||
0084|028|H|To help you remember, take it at the same times each day.||
0084|029|H|   Do not stop taking this medication without consulting your||
0084|030|H|doctor.||
0084|031|B|||
0084|032|S|SIDE EFFECTS:  Dizziness, stomach upset, diarrhea, vomiting,||
0084|033|S|headache, and flushing may occur as your body adjusts to the||
0084|034|S|medication. If any of these effects last or get worse, tell your||
0084|035|S|doctor or pharmacist promptly.||
0084|036|S|   To reduce the risk of dizziness and lightheadedness, get up||
0084|037|S|slowly when rising from a sitting or lying position.||
0084|038|S|   Remember that this medication has been prescribed because your||
0084|039|S|doctor has judged that the benefit to you is greater than the||
0084|040|S|risk of side effects. Many people using this medication do not||
0084|041|S|have serious side effects.||
0084|042|S|   Tell your doctor right away if you have any serious side||
0084|043|S|effects, including: fainting, stomach pain, yellowing eyes/skin,||
0084|044|S|dark urine, unusual bleeding/bruising.||
0084|045|S|   Get medical help right away if you have any very serious side||
0084|046|S|effects, including: chest pain, severe headache, weakness on one||
0084|047|S|side of the body, vision changes, trouble speaking, confusion.||
0084|048|S|   A very serious allergic reaction to this drug is rare.||
0084|049|S|However, get medical help right away if you notice any symptoms||
0084|050|S|of a serious allergic reaction, including: rash, itching/swelling||
0084|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0084|052|S|breathing.||
0084|053|S|   This is not a complete list of possible side effects. If you||
0084|054|S|notice other effects not listed above, contact your doctor or||
0084|055|S|pharmacist.||
0084|056|S|   In the US -||
0084|057|S|   Call your doctor for medical advice about side effects. You||
0084|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0084|059|S|www.fda.gov/medwatch.||
0084|060|S|   In Canada - Call your doctor for medical advice about side||
0084|061|S|effects. You may report side effects to Health Canada at||
0084|062|S|1-866-234-2345.||
0084|063|B|||
0084|064|P|PRECAUTIONS:  Before taking dipyridamole, tell your doctor or||
0084|065|P|pharmacist if you are allergic to it; or if you have any other||
0084|066|P|allergies. This product may contain inactive ingredients, which||
0084|067|P|can cause allergic reactions or other problems. Talk to your||
0084|068|P|pharmacist for more details.||
0084|069|P|   Before using this medication, tell your doctor or pharmacist||
0084|070|P|your medical history, especially of: other heart problems (such||
0084|071|P|as severe coronary artery disease, recent heart attack), low||
0084|072|P|blood pressure (hypotension), liver disease, a certain muscle||
0084|073|P|problem (myasthenia gravis).||
0084|074|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0084|075|P|can make you more dizzy. Do not drive, use machinery, or do||
0084|076|P|anything that needs alertness until you can do it safely. Limit||
0084|077|P|alcoholic beverages. Talk to your doctor if you are using||
0084|078|P|marijuana (cannabis).||
0084|079|P|   Before having surgery, tell your doctor or dentist about all||
0084|080|P|the products you use (including prescription drugs,||
0084|081|P|nonprescription drugs, and herbal products).||
0084|082|P|   Older adults may be more sensitive to the side effects of this||
0084|083|P|drug, especially dizziness and bleeding.||
0084|084|P|   During pregnancy, this medication should be used only when||
0084|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
0084|086|P|   This medication passes into breast milk. Consult your doctor||
0084|087|P|before breastfeeding.||
0084|088|B|||
0084|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0084|090|I|medications work or increase your risk for serious side effects.||
0084|091|I|This document does not contain all possible drug interactions.||
0084|092|I|Keep a list of all the products you use (including||
0084|093|I|prescription/nonprescription drugs and herbal products) and share||
0084|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
0084|095|I|the dosage of any medicines without your doctor's approval.||
0084|096|I|   A product that may interact with this drug is: riociguat.||
0084|097|I|   If you are currently taking aspirin, talk to your doctor right||
0084|098|I|away and ask if you should keep taking it with this medication.||
0084|099|I|If you are not currently taking aspirin, talk to your doctor||
0084|100|I|before starting it for any medical condition.||
0084|101|I|   This medication is sometimes used together with other drugs||
0084|102|I|that may increase your risk of bleeding. Examples are certain||
0084|103|I|"blood thinners" (such as heparin, warfarin). Follow your||
0084|104|I|doctor's instructions carefully and continue your medications as||
0084|105|I|directed. Tell your doctor if you notice unusual bleeding.||
0084|106|I|Consult your doctor or pharmacist for more details.||
0084|107|I|   This medication may interfere with certain medical/lab tests||
0084|108|I|(such as chemical stress tests using adenosine/dipyridamole),||
0084|109|I|possibly causing false test results. Make sure lab personnel and||
0084|110|I|all your doctors know you use this drug.||
0084|111|B|||
0084|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0084|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0084|114|O|poison control center right away. US residents can call||
0084|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0084|116|O|Symptoms of overdose may include: flushing, sweating,||
0084|117|O|restlessness, weakness, dizziness, fast heartbeat.||
0084|118|B|||
0084|119|N|NOTES:  Do not share this medication with others.||
0084|120|B|||
0084|121|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0084|122|D|remember. If it is near the time of the next dose, skip the||
0084|123|D|missed dose. Take your next dose at the regular time. Do not||
0084|124|D|double the dose to catch up.||
0084|125|B|||
0084|126|R|STORAGE:  Store at room temperature away from light and moisture.||
0084|127|R|Do not store in the bathroom. Keep all medications away from||
0084|128|R|children and pets.||
0084|129|R|   Do not flush medications down the toilet or pour them into a||
0084|130|R|drain unless instructed to do so. Properly discard this product||
0084|131|R|when it is expired or no longer needed. Consult your pharmacist||
0084|132|R|or local waste disposal company.||
0084|133|B|||
0084|134|M|MEDICAL ALERT:  Your condition can cause complications in a||
0084|135|M|medical emergency. For information about enrolling in MedicAlert,||
0084|136|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0084|137|B|||
0084|138|A|Information last revised April 2025.||
0084|139|A|Copyright(c) 2025 First Databank, Inc.||
0084|140|B|||
0085|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0085|002|Z|does NOT have all possible information about this product. This||
0085|003|Z|information does not assure that this product is safe, effective,||
0085|004|Z|or appropriate for you. This information is not individual||
0085|005|Z|medical advice and does not substitute for the advice of your||
0085|006|Z|health care professional. Always ask your health care||
0085|007|Z|professional for complete information about this product and your||
0085|008|Z|specific health needs.||
0085|009|B|||
0085|010|T|DISOPYRAMIDE - ORAL||
0085|011|F|(DYE-soe-PIR-a-mide)||
0085|012|B|||
0085|013|C|COMMON BRAND NAME(S): Norpace||
0085|014|B|||
0085|015|W|WARNING:  Though this medication often gives great benefits to||
0085|016|W|people with irregular heartbeat, it may rarely cause a serious||
0085|017|W|new irregular heartbeat. When starting treatment with this drug,||
0085|018|W|your doctor may recommend that you stay in the hospital for||
0085|019|W|proper monitoring and emergency medical treatment if needed. Talk||
0085|020|W|with your doctor about the benefits and risks of taking this||
0085|021|W|medication.||
0085|022|B|||
0085|023|U|USES:  This medication is used to treat certain types of serious||
0085|024|U|(possibly fatal) irregular heartbeat (such as sustained||
0085|025|U|ventricular tachycardia). It is used to restore normal heart||
0085|026|U|rhythm and maintain a regular, steady heartbeat. Disopyramide is||
0085|027|U|known as an anti-arrhythmic drug. It works by blocking certain||
0085|028|U|electrical signals in the heart that can cause an irregular||
0085|029|U|heartbeat. Treating an irregular heartbeat can decrease the risk||
0085|030|U|for blood clots, and this effect can reduce your risk of heart||
0085|031|U|attack or stroke.||
0085|032|B|||
0085|033|H|HOW TO USE:  Take this medication by mouth with or without food||
0085|034|H|exactly as prescribed by your doctor. If you are taking the||
0085|035|H|immediate-release form, take it as directed by your doctor,||
0085|036|H|usually 4 times daily.||
0085|037|H|   If you are taking the extended-release form, take it as||
0085|038|H|directed by your doctor, usually twice a day. Swallow||
0085|039|H|extended-release capsules whole. Do not crush or chew||
0085|040|H|extended-release capsules or tablets. Doing so can release all of||
0085|041|H|the drug at once, increasing the risk of side effects. Swallow||
0085|042|H|the whole tablet without crushing or chewing.||
0085|043|H|   The dosage is based on your age, medical condition, and||
0085|044|H|response to treatment.||
0085|045|H|   Use this medication regularly to get the most benefit from it.||
0085|046|H|To help you remember, take it at the same times each day.||
0085|047|H|   Tell your doctor if your condition does not get better or if||
0085|048|H|it gets worse.||
0085|049|B|||
0085|050|S|SIDE EFFECTS:  See also Warning section.||
0085|051|S|   Dry mouth, constipation, nausea, abdominal pain/gas/bloating,||
0085|052|S|blurred vision, dizziness, dry nose/eyes/throat, and urination||
0085|053|S|problems (such as difficulty urinating or unusual frequent urge||
0085|054|S|to urinate) may occur. If any of these effects last or get worse,||
0085|055|S|tell your doctor or pharmacist promptly.||
0085|056|S|   Remember that this medication has been prescribed because your||
0085|057|S|doctor has judged that the benefit to you is greater than the||
0085|058|S|risk of side effects. Many people using this medication do not||
0085|059|S|have serious side effects.||
0085|060|S|   Tell your doctor right away if you have any serious side||
0085|061|S|effects, including: symptoms of low blood sugar (such as||
0085|062|S|shakiness with unusual hunger/headache/sweating), signs of liver||
0085|063|S|problems (such as nausea/vomiting that doesn't stop,||
0085|064|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), muscle||
0085|065|S|weakness, worsening symptoms of heart failure (such as shortness||
0085|066|S|of breath, swelling ankles/feet, unusual tiredness,||
0085|067|S|unusual/sudden weight gain).||
0085|068|S|   Get medical help right away if you have any very serious side||
0085|069|S|effects, including: fainting, faster/more irregular heartbeat,||
0085|070|S|severe dizziness.||
0085|071|S|   A very serious allergic reaction to this drug is rare.||
0085|072|S|However, get medical help right away if you notice any symptoms||
0085|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0085|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0085|075|S|breathing.||
0085|076|S|   This is not a complete list of possible side effects. If you||
0085|077|S|notice other effects not listed above, contact your doctor or||
0085|078|S|pharmacist.||
0085|079|S|   In the US -||
0085|080|S|   Call your doctor for medical advice about side effects. You||
0085|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0085|082|S|www.fda.gov/medwatch.||
0085|083|S|   In Canada - Call your doctor for medical advice about side||
0085|084|S|effects. You may report side effects to Health Canada at||
0085|085|S|1-866-234-2345.||
0085|086|B|||
0085|087|P|PRECAUTIONS:  Before taking disopyramide, tell your doctor or||
0085|088|P|pharmacist if you are allergic to it; or if you have any other||
0085|089|P|allergies. This product may contain inactive ingredients, which||
0085|090|P|can cause allergic reactions or other problems. Talk to your||
0085|091|P|pharmacist for more details.||
0085|092|P|   Before using this medication, tell your doctor or pharmacist||
0085|093|P|your medical history, especially of: diabetes, glaucoma, kidney||
0085|094|P|disease, liver problems, myasthenia gravis, urinary problems||
0085|095|P|(such as due to enlarged prostate, urinary retention).||
0085|096|P|   This drug may rarely make you dizzy. Alcohol or marijuana||
0085|097|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
0085|098|P|or do anything that needs alertness until you can do it safely.||
0085|099|P|Limit alcoholic beverages. Talk to your doctor if you are using||
0085|100|P|marijuana (cannabis).||
0085|101|P|   Before having surgery, tell your doctor or dentist about all||
0085|102|P|the products you use (including prescription drugs,||
0085|103|P|nonprescription drugs, and herbal products).||
0085|104|P|   Disopyramide may cause a condition that affects the heart||
0085|105|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0085|106|P|serious (rarely fatal) fast/irregular heartbeat and other||
0085|107|P|symptoms (such as severe dizziness, fainting) that need medical||
0085|108|P|attention right away.||
0085|109|P|   The risk of QT prolongation may be increased if you have||
0085|110|P|certain medical conditions or are taking other drugs that may||
0085|111|P|cause QT prolongation. Before using disopyramide, tell your||
0085|112|P|doctor or pharmacist of all the drugs you take and if you have||
0085|113|P|any of the following conditions: certain heart problems (heart||
0085|114|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0085|115|P|history of certain heart problems (QT prolongation in the EKG,||
0085|116|P|sudden cardiac death).||
0085|117|P|   Low levels of potassium or magnesium in the blood may also||
0085|118|P|increase your risk of QT prolongation. This risk may increase if||
0085|119|P|you use certain drugs (such as diuretics/"water pills") or if you||
0085|120|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0085|121|P|Talk to your doctor about using disopyramide safely.||
0085|122|P|   This drug may cause low blood sugar (hypoglycemia), especially||
0085|123|P|if you have diabetes, heart failure, decreased kidney/liver||
0085|124|P|function, or nutrition problems. Tell your doctor right away if||
0085|125|P|you have symptoms of low blood sugar including sudden sweating,||
0085|126|P|shaking, fast heartbeat, hunger, blurred vision, dizziness, or||
0085|127|P|tingling hands/feet. If you have diabetes, your diabetes||
0085|128|P|medication, exercise program, or diet may need to be adjusted.||
0085|129|P|   Older adults may be more sensitive to the side effects of this||
0085|130|P|drug, especially urination problems and QT prolongation (see||
0085|131|P|above).||
0085|132|P|   During pregnancy, this medication should be used only when||
0085|133|P|clearly needed. Rarely, disopyramide may cause early labor during||
0085|134|P|pregnancy. Discuss the risks and benefits with your doctor.||
0085|135|P|   This medication passes into breast milk, and the effect on a||
0085|136|P|nursing infant is unknown. Consult your doctor before||
0085|137|P|breastfeeding.||
0085|138|B|||
0085|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0085|140|I|medications work or increase your risk for serious side effects.||
0085|141|I|This document does not contain all possible drug interactions.||
0085|142|I|Keep a list of all the products you use (including||
0085|143|I|prescription/nonprescription drugs and herbal products) and share||
0085|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
0085|145|I|the dosage of any medicines without your doctor's approval.||
0085|146|I|   Some products that may interact with this drug include:||
0085|147|I|fingolimod, certain calcium channel blockers (diltiazem and||
0085|148|I|verapamil).||
0085|149|I|   Many drugs besides disopyramide may affect the heart rhythm||
0085|150|I|(QT prolongation), including amiodarone, dofetilide, flecainide,||
0085|151|I|ketoconazole, pimozide, procainamide, quinidine, sotalol,||
0085|152|I|macrolide antibiotics (such as clarithromycin, erythromycin),||
0085|153|I|among others. (See also Precautions section.)||
0085|154|I|   Other medications can affect the removal of disopyramide from||
0085|155|I|your body, which may affect how disopyramide works. Examples||
0085|156|I|include phenytoin, among others.||
0085|157|B|||
0085|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0085|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0085|160|O|poison control center right away. US residents can call||
0085|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0085|162|O|Symptoms of overdose may include: fainting, new irregular||
0085|163|O|heartbeat, slowed breathing.||
0085|164|B|||
0085|165|N|NOTES:  Do not share this medication with others.||
0085|166|N|   Lab and/or medical tests (such as EKG) should be done while||
0085|167|N|you are taking this medication. Keep all medical and lab||
0085|168|N|appointments. Consult your doctor for more details.||
0085|169|B|||
0085|170|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0085|171|D|remember. If it is near the time of the next dose, skip the||
0085|172|D|missed dose. Take your next dose at the regular time. Do not||
0085|173|D|double the dose to catch up.||
0085|174|B|||
0085|175|R|STORAGE:  Store at room temperature away from light and moisture.||
0085|176|R|Do not store in the bathroom. Keep all medications away from||
0085|177|R|children and pets.||
0085|178|R|   Do not flush medications down the toilet or pour them into a||
0085|179|R|drain unless instructed to do so. Properly discard this product||
0085|180|R|when it is expired or no longer needed. Consult your pharmacist||
0085|181|R|or local waste disposal company.||
0085|182|B|||
0085|183|M|MEDICAL ALERT:  Your condition can cause complications in a||
0085|184|M|medical emergency. For information about enrolling in MedicAlert,||
0085|185|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0085|186|B|||
0085|187|A|Information last revised May 2025.||
0085|188|A|Copyright(c) 2025 First Databank, Inc.||
0085|189|B|||
0086|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0086|002|Z|does NOT have all possible information about this product. This||
0086|003|Z|information does not assure that this product is safe, effective,||
0086|004|Z|or appropriate for you. This information is not individual||
0086|005|Z|medical advice and does not substitute for the advice of your||
0086|006|Z|health care professional. Always ask your health care||
0086|007|Z|professional for complete information about this product and your||
0086|008|Z|specific health needs.||
0086|009|B|||
0086|010|T|PHENAZOPYRIDINE - ORAL||
0086|011|F|(fen-AY-zoe-PIR-i-deen)||
0086|012|B|||
0086|013|C|COMMON BRAND NAME(S): Pyridium||
0086|014|B|||
0086|015|U|USES:  This medication is used to relieve symptoms caused by||
0086|016|U|irritation of the urinary tract such as pain, burning, and the||
0086|017|U|feeling of needing to urinate urgently or often. This drug does||
0086|018|U|not treat the cause of the urinary irritation, but it can help||
0086|019|U|relieve the symptoms while other treatments take effect.||
0086|020|U|Phenazopyridine is a dye that works as a painkiller to soothe the||
0086|021|U|lining of the urinary tract.||
0086|022|B|||
0086|023|H|HOW TO USE:  Take this medication by mouth after meals, usually 3||
0086|024|H|times daily or as directed by your doctor. If you are taking this||
0086|025|H|medication along with antibiotics for symptoms related to a||
0086|026|H|urinary tract infection, or are self-treating, do not take it for||
0086|027|H|more than 2 days without talking to your doctor.||
0086|028|H|   The dosage is based on your medical condition and response to||
0086|029|H|treatment.||
0086|030|H|   Tell your doctor if your condition lasts or gets worse.||
0086|031|B|||
0086|032|S|SIDE EFFECTS:  Headache, dizziness, or stomach upset may occur.||
0086|033|S|If any of these effects last or get worse, notify your doctor or||
0086|034|S|pharmacist promptly.||
0086|035|S|   If your doctor has directed you to use this medication,||
0086|036|S|remember that your doctor has judged that the benefit to you is||
0086|037|S|greater than the risk of side effects. Many people using this||
0086|038|S|medication do not have serious side effects.||
0086|039|S|   Tell your doctor right away if you have any serious side||
0086|040|S|effects, including: yellowing skin/eyes, dark urine, signs of||
0086|041|S|kidney problems (such as change in the amount of urine, bloody||
0086|042|S|urine), stomach/abdominal pain, vomiting, fever, chills, easy||
0086|043|S|bruising/bleeding, unusual tiredness, shortness of breath, fast||
0086|044|S|heartbeat, seizures.||
0086|045|S|   A very serious allergic reaction to this drug is rare.||
0086|046|S|However, get medical help right away if you notice any symptoms||
0086|047|S|of a serious allergic reaction, including: rash, itching/swelling||
0086|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0086|049|S|breathing.||
0086|050|S|   This is not a complete list of possible side effects. If you||
0086|051|S|notice other effects not listed above, contact your doctor or||
0086|052|S|pharmacist.||
0086|053|S|   In the US -||
0086|054|S|   Call your doctor for medical advice about side effects. You||
0086|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0086|056|S|www.fda.gov/medwatch.||
0086|057|S|   In Canada - Call your doctor for medical advice about side||
0086|058|S|effects. You may report side effects to Health Canada at||
0086|059|S|1-866-234-2345.||
0086|060|B|||
0086|061|P|PRECAUTIONS:  Before taking phenazopyridine, tell your doctor or||
0086|062|P|pharmacist if you are allergic to it; or if you have any other||
0086|063|P|allergies. This product may contain inactive ingredients, which||
0086|064|P|can cause allergic reactions or other problems. Talk to your||
0086|065|P|pharmacist for more details.||
0086|066|P|   Before using this medication, tell your doctor or pharmacist||
0086|067|P|your medical history, especially of: kidney disease, liver||
0086|068|P|disease, blood disorders (such as G6PD deficiency, hemolytic||
0086|069|P|anemia).||
0086|070|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0086|071|P|can make you more dizzy. Do not drive, use machinery, or do||
0086|072|P|anything that needs alertness until you can do it safely. Limit||
0086|073|P|alcoholic beverages. Talk to your doctor if you are using||
0086|074|P|marijuana (cannabis).||
0086|075|P|   Before having surgery, tell your doctor or dentist about all||
0086|076|P|the products you use (including prescription drugs,||
0086|077|P|nonprescription drugs, and herbal products).||
0086|078|P|   Phenazopyridine can dye your urine and tears orange-red. This||
0086|079|P|may stain clothing and contact lenses. Do not wear contact lenses||
0086|080|P|while using this medication. Urine and tears will return to||
0086|081|P|normal color after the medication is stopped.||
0086|082|P|   Tell your doctor if you are pregnant before using this||
0086|083|P|medication.||
0086|084|P|   It is unknown if this drug passes into breast milk. Consult||
0086|085|P|your doctor before breastfeeding.||
0086|086|B|||
0086|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0086|088|I|medications work or increase your risk for serious side effects.||
0086|089|I|This document does not contain all possible drug interactions.||
0086|090|I|Keep a list of all the products you use (including||
0086|091|I|prescription/nonprescription drugs and herbal products) and share||
0086|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
0086|093|I|the dosage of any medicines without your doctor's approval.||
0086|094|I|   This medication may interfere with certain lab tests (such as||
0086|095|I|urine tests for kidney function, bilirubin, and sugar levels),||
0086|096|I|possibly causing false test results. Make sure lab personnel and||
0086|097|I|all your doctors know you use this drug.||
0086|098|B|||
0086|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0086|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0086|101|O|poison control center right away. US residents can call||
0086|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0086|103|O|Symptoms of overdose may include unusual tiredness, skin color||
0086|104|O|changes, change in the amount of urine, shortness of breath, fast||
0086|105|O|heartbeat, yellowing skin/eyes, easy bleeding/bruising, or||
0086|106|O|seizures.||
0086|107|B|||
0086|108|N|NOTES:  Do not share this medication with others.||
0086|109|N|   This medication has been prescribed for your current condition||
0086|110|N|only. Do not take it later for another pain-related condition of||
0086|111|N|the urinary tract unless told to do so by your doctor. A||
0086|112|N|different medication may be necessary in those cases.||
0086|113|B|||
0086|114|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0086|115|D|remember. If it is near the time of the next dose, skip the||
0086|116|D|missed dose. Take your next dose at the regular time. Do not||
0086|117|D|double the dose to catch up.||
0086|118|B|||
0086|119|R|STORAGE:  Store at room temperature away from light and moisture.||
0086|120|R|Do not store in the bathroom. Keep all medications away from||
0086|121|R|children and pets.||
0086|122|R|   Do not flush medications down the toilet or pour them into a||
0086|123|R|drain unless instructed to do so. Properly discard this product||
0086|124|R|when it is expired or no longer needed. Consult your pharmacist||
0086|125|R|or local waste disposal company.||
0086|126|B|||
0086|127|A|Information last revised May 2024.||
0086|128|A|Copyright(c) 2025 First Databank, Inc.||
0086|129|B|||
0087|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0087|002|Z|does NOT have all possible information about this product. This||
0087|003|Z|information does not assure that this product is safe, effective,||
0087|004|Z|or appropriate for you. This information is not individual||
0087|005|Z|medical advice and does not substitute for the advice of your||
0087|006|Z|health care professional. Always ask your health care||
0087|007|Z|professional for complete information about this product and your||
0087|008|Z|specific health needs.||
0087|009|B|||
0087|010|T|METAXALONE - ORAL||
0087|011|F|(me-TAX-a-lone)||
0087|012|B|||
0087|013|C|COMMON BRAND NAME(S): Skelaxin||
0087|014|B|||
0087|015|U|USES:  Metaxalone is used to treat muscle spasms/pain. It is||
0087|016|U|usually used along with rest, physical therapy, and other||
0087|017|U|treatment.||
0087|018|B|||
0087|019|H|HOW TO USE:  Take this medication by mouth with or without food||
0087|020|H|as directed by your doctor. Do not increase your dose or use this||
0087|021|H|drug more often or for longer than prescribed. Your condition||
0087|022|H|will not improve any faster, and your risk of side effects will||
0087|023|H|increase. If you take this medication after a high-fat meal and||
0087|024|H|experience side effects, it may be best to take this drug on an||
0087|025|H|empty stomach or after a light meal.||
0087|026|H|   The dosage is based on your medical condition and response to||
0087|027|H|treatment.||
0087|028|H|   Metaxalone comes in different brands which provide different||
0087|029|H|amounts of the medication. Do not switch between brands of this||
0087|030|H|medication unless directed by your doctor.||
0087|031|H|   To prevent a very serious high blood pressure reaction, it is||
0087|032|H|very important that you follow a special diet recommended by your||
0087|033|H|doctor or dietician to limit your intake of tyramine while you||
0087|034|H|are taking this medicine. Avoid foods and beverages that are high||
0087|035|H|in tyramine, including aged cheeses, dried/aged meats and||
0087|036|H|sausages (such as salami, liverwurst), preserved fish (such as||
0087|037|H|pickled herring), products that contain large amounts of yeast||
0087|038|H|(such as bouillon cubes, powdered soup/gravy, homemade or||
0087|039|H|sourdough bread), fermented foods (such as sauerkraut, kim chee),||
0087|040|H|most soybean products (such as soy sauce, tofu), broad/fava||
0087|041|H|beans, red wine, sherry, tap beers, and vermouth. Consult your||
0087|042|H|doctor or dietician for more details and a complete list of other||
0087|043|H|foods that contain tyramine which you should limit or avoid.||
0087|044|H|   Tell your doctor if your condition does not get better or if||
0087|045|H|it gets worse.||
0087|046|B|||
0087|047|S|SIDE EFFECTS:  Drowsiness, dizziness, nausea, vomiting, and upset||
0087|048|S|stomach may occur. If any of these effects last or get worse,||
0087|049|S|tell your doctor or pharmacist promptly.||
0087|050|S|   Remember that this medication has been prescribed because your||
0087|051|S|doctor has judged that the benefit to you is greater than the||
0087|052|S|risk of side effects. Many people using this medication do not||
0087|053|S|have serious side effects.||
0087|054|S|   Tell your doctor right away if you have any serious side||
0087|055|S|effects, including: mental/mood changes (such as nervousness,||
0087|056|S|irritability, confusion), signs of infection (such as sore throat||
0087|057|S|that doesn't go away, fever, chills), yellowing eyes/skin,||
0087|058|S|unusual tiredness, dark urine.||
0087|059|S|   This medication may increase serotonin and rarely cause a very||
0087|060|S|serious condition called serotonin syndrome/toxicity. The risk||
0087|061|S|increases if you are also taking other drugs that increase||
0087|062|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0087|063|S|take (see Drug Interactions section). Get medical help right away||
0087|064|S|if you develop some of the following symptoms: fast heartbeat,||
0087|065|S|hallucinations, loss of coordination, severe dizziness, severe||
0087|066|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0087|067|S|unusual agitation/restlessness.||
0087|068|S|   This drug may rarely cause an attack of extremely high blood||
0087|069|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
0087|070|S|food interactions can increase this risk (see How to Use and Drug||
0087|071|S|Interactions sections). Get medical help right away if any of||
0087|072|S|these serious side effects occur: severe headache,||
0087|073|S|fast/slow/irregular/pounding heartbeat, chest pain, neck||
0087|074|S|stiffness/soreness, severe nausea/vomiting, sweating/clammy skin||
0087|075|S|(sometimes with fever), widened pupils, vision changes (such as||
0087|076|S|double/blurred vision), sudden sensitivity to light||
0087|077|S|(photophobia).||
0087|078|S|   A very serious allergic reaction to this drug is rare.||
0087|079|S|However, get medical help right away if you notice any symptoms||
0087|080|S|of a serious allergic reaction, including: rash, itching/swelling||
0087|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0087|082|S|breathing.||
0087|083|S|   This is not a complete list of possible side effects. If you||
0087|084|S|notice other effects not listed above, contact your doctor or||
0087|085|S|pharmacist.||
0087|086|S|   In the US -||
0087|087|S|   Call your doctor for medical advice about side effects. You||
0087|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0087|089|S|www.fda.gov/medwatch.||
0087|090|S|   In Canada - Call your doctor for medical advice about side||
0087|091|S|effects. You may report side effects to Health Canada at||
0087|092|S|1-866-234-2345.||
0087|093|B|||
0087|094|P|PRECAUTIONS:  Before taking metaxalone, tell your doctor or||
0087|095|P|pharmacist if you are allergic to it; or if you have any other||
0087|096|P|allergies. This product may contain inactive ingredients, which||
0087|097|P|can cause allergic reactions or other problems. Talk to your||
0087|098|P|pharmacist for more details.||
0087|099|P|   Before using this medication, tell your doctor or pharmacist||
0087|100|P|your medical history, especially of: liver disease, kidney||
0087|101|P|disease, anemia, seizures.||
0087|102|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0087|103|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0087|104|P|machinery, or do anything that needs alertness until you can do||
0087|105|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0087|106|P|are using marijuana (cannabis).||
0087|107|P|   Before having surgery, tell your doctor or dentist about all||
0087|108|P|the products you use (including prescription drugs,||
0087|109|P|nonprescription drugs, and herbal products).||
0087|110|P|   Older adults may be more sensitive to the side effects of this||
0087|111|P|drug, especially dizziness, drowsiness, or confusion. These side||
0087|112|P|effects can increase the risk of falling.||
0087|113|P|   During pregnancy, this medication should be used only when||
0087|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
0087|115|P|   It is unknown if this drug passes into breast milk. Consult||
0087|116|P|your doctor before breastfeeding.||
0087|117|B|||
0087|118|I|DRUG INTERACTIONS:  See also How to Use section.||
0087|119|I|   Drug interactions may change how your medications work or||
0087|120|I|increase your risk for serious side effects. This document does||
0087|121|I|not contain all possible drug interactions. Keep a list of all||
0087|122|I|the products you use (including prescription/nonprescription||
0087|123|I|drugs and herbal products) and share it with your doctor and||
0087|124|I|pharmacist. Do not start, stop, or change the dosage of any||
0087|125|I|medicines without your doctor's approval.||
0087|126|I|   Some products that may interact with this drug include: diet||
0087|127|I|pills/appetite suppressants (such as diethylpropion), drugs for||
0087|128|I|attention deficit disorder (such as atomoxetine,||
0087|129|I|methylphenidate), apraclonidine, bupropion, buspirone,||
0087|130|I|carbamazepine, cyclobenzaprine, deutetrabenazine, a certain||
0087|131|I|combination product (dextromethorphan/quinidine), maprotiline,||
0087|132|I|methyldopa, metoclopramide, certain opioid pain relievers (such||
0087|133|I|as fentanyl, meperidine, methadone, tapentadol), certain drugs||
0087|134|I|for Parkinson's disease (such as entacapone, levodopa,||
0087|135|I|tolcapone), certain supplements (such as tryptophan, tyramine),||
0087|136|I|tetrabenazine, tricyclic antidepressants (such as amitriptyline,||
0087|137|I|doxepin), valbenazine.||
0087|138|I|   The risk of serotonin syndrome/toxicity increases if you are||
0087|139|I|also taking other drugs that increase serotonin. Examples include||
0087|140|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0087|141|I|antidepressants (including mirtazapine, SSRIs such as||
0087|142|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
0087|143|I|tramadol, certain "triptans" used to treat migraine headaches||
0087|144|I|(such as rizatriptan, sumatriptan, zolmitriptan), among others.||
0087|145|I|The risk of serotonin syndrome/toxicity may be more likely when||
0087|146|I|you start or increase the dose of these drugs.||
0087|147|I|   Some products can interact with metaxalone if you take them||
0087|148|I|together, or even if you take them weeks before or after taking||
0087|149|I|metaxalone. Tell your doctor or pharmacist if you take anything||
0087|150|I|in the list of products that may interact with this drug, or any||
0087|151|I|of the products that increase serotonin, within 2 weeks before or||
0087|152|I|after taking metaxalone. Also tell them if you have taken||
0087|153|I|fluoxetine within 5 weeks before starting metaxalone. Ask your||
0087|154|I|doctor how much time to wait between starting or stopping any of||
0087|155|I|these drugs and starting metaxalone.||
0087|156|I|   Taking other MAO inhibitors with this medication may cause a||
0087|157|I|serious (possibly fatal) drug interaction. Do not take any other||
0087|158|I|MAO inhibitors (isocarboxazid, linezolid, methylene blue,||
0087|159|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0087|160|I|selegiline, tranylcypromine) during treatment with this||
0087|161|I|medication. Most MAO inhibitors should also not be taken for two||
0087|162|I|weeks before and after treatment with this medication. Ask your||
0087|163|I|doctor when to start or stop taking this medication.||
0087|164|I|   Before using metaxalone, report the use of drugs that may||
0087|165|I|increase the risk of extremely high blood pressure (hypertensive||
0087|166|I|crisis) when combined with metaxalone, including herbal products||
0087|167|I|(such as ephedra/ma huang), nasal decongestants (such as||
0087|168|I|phenylephrine, pseudoephedrine), and stimulants (such as||
0087|169|I|amphetamines, ephedrine, epinephrine, phenylalanine). Metaxalone||
0087|170|I|should not be used with any of these medications. Talk to your||
0087|171|I|doctor or pharmacist for more details.||
0087|172|I|   Tell your doctor or pharmacist if you are taking other||
0087|173|I|products that cause drowsiness such as opioid pain or cough||
0087|174|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0087|175|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0087|176|I|lorazepam, zolpidem), other muscle relaxants (such as||
0087|177|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0087|178|I|cetirizine, diphenhydramine).||
0087|179|I|   Check the labels on all your medicines (such as allergy or||
0087|180|I|cough-and-cold products) because they may contain ingredients||
0087|181|I|that cause drowsiness. Ask your pharmacist about using those||
0087|182|I|products safely.||
0087|183|I|   This medication may interfere with certain lab tests (such as||
0087|184|I|certain urine glucose tests), possibly causing false test||
0087|185|I|results. Make sure lab personnel and all your doctors know you||
0087|186|I|use this drug.||
0087|187|B|||
0087|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0087|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0087|190|O|poison control center right away. US residents can call||
0087|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0087|192|O|Symptoms of overdose may include: severe drowsiness.||
0087|193|B|||
0087|194|N|NOTES:  Do not share this medication with others.||
0087|195|N|   This medication has been prescribed for your current condition||
0087|196|N|only. Do not use it later for another condition unless your||
0087|197|N|doctor directs you to do so. A different medication may be||
0087|198|N|necessary in that case.||
0087|199|B|||
0087|200|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0087|201|D|remember. If it is near the time of the next dose, skip the||
0087|202|D|missed dose. Take your next dose at the regular time. Do not||
0087|203|D|double the dose to catch up.||
0087|204|B|||
0087|205|R|STORAGE:  Store at room temperature away from light and moisture.||
0087|206|R|Do not store in the bathroom. Keep all medications away from||
0087|207|R|children and pets.||
0087|208|R|   Do not flush medications down the toilet or pour them into a||
0087|209|R|drain unless instructed to do so. Properly discard this product||
0087|210|R|when it is expired or no longer needed. Consult your pharmacist||
0087|211|R|or local waste disposal company.||
0087|212|B|||
0087|213|A|Information last revised April 2025.||
0087|214|A|Copyright(c) 2025 First Databank, Inc.||
0087|215|B|||
0089|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0089|002|Z|does NOT have all possible information about this product. This||
0089|003|Z|information does not assure that this product is safe, effective,||
0089|004|Z|or appropriate for you. This information is not individual||
0089|005|Z|medical advice and does not substitute for the advice of your||
0089|006|Z|health care professional. Always ask your health care||
0089|007|Z|professional for complete information about this product and your||
0089|008|Z|specific health needs.||
0089|009|B|||
0089|010|T|TRAZODONE - ORAL||
0089|011|F|(TRAZ-oh-done)||
0089|012|B|||
0089|013|C|COMMON BRAND NAME(S): Desyrel, Raldesy||
0089|014|B|||
0089|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0089|016|W|of conditions, including depression and other mental/mood||
0089|017|W|disorders. These medications can help prevent suicidal||
0089|018|W|thoughts/attempts and provide other important benefits. However,||
0089|019|W|studies have shown that a small number of people (especially||
0089|020|W|people younger than 25) who take antidepressants for any||
0089|021|W|condition may experience worsening depression, other mental/mood||
0089|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0089|023|W|talk with the doctor about the risks and benefits of||
0089|024|W|antidepressant medication (especially for people younger than||
0089|025|W|25), even if treatment is not for a mental/mood condition.||
0089|026|W|   Tell the doctor right away if you notice worsening||
0089|027|W|depression/other psychiatric conditions, unusual behavior changes||
0089|028|W|(including possible suicidal thoughts/attempts), or other||
0089|029|W|mental/mood changes (including new/worsening anxiety, panic||
0089|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0089|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0089|032|W|especially watchful for these symptoms when a new antidepressant||
0089|033|W|is started or when the dose is changed.||
0089|034|B|||
0089|035|U|USES:  This medication is used to treat depression. Trazodone||
0089|036|U|works by helping to restore the balance of a certain natural||
0089|037|U|substance (serotonin) in the brain.||
0089|038|B|||
0089|039|H|HOW TO USE:  Read the Medication Guide provided by your||
0089|040|H|pharmacist before you start using trazodone and each time you get||
0089|041|H|a refill. If you have any questions, consult your doctor or||
0089|042|H|pharmacist.||
0089|043|H|   Take this medication by mouth after a meal or snack as||
0089|044|H|directed by your doctor, usually once or twice daily. If||
0089|045|H|drowsiness is a problem and you are taking 1 dose daily, take it||
0089|046|H|at bedtime. If you are taking 2 doses each day, it may help to||
0089|047|H|take 1 of the doses at bedtime. Follow your doctor's directions||
0089|048|H|carefully.||
0089|049|H|   If you are using the liquid form of this medication, read the||
0089|050|H|Instructions for Use if available from your pharmacist before you||
0089|051|H|start using trazodone and each time you get a refill. Carefully||
0089|052|H|measure the dose using the special measuring device that is||
0089|053|H|provided. Do not use a household spoon because you may not get||
0089|054|H|the correct dose. Rinse the syringe with water after each use.||
0089|055|H|Consult your doctor or pharmacist if you have any questions.||
0089|056|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0089|057|H|using this medication unless your doctor or pharmacist says you||
0089|058|H|may do so safely. Grapefruit can increase the chance of side||
0089|059|H|effects with this medicine. Ask your doctor or pharmacist for||
0089|060|H|more details.||
0089|061|H|   Dosage is based on your medical condition and response to||
0089|062|H|treatment. To reduce your risk of side effects, your doctor may||
0089|063|H|start you at a low dose and gradually increase your dose.||
0089|064|H|   Take this medication exactly as prescribed. Do not increase||
0089|065|H|your dose or take this medication more often than prescribed.||
0089|066|H|Your condition will not improve any faster, and the risk of||
0089|067|H|serious side effects may be increased.||
0089|068|H|   Keep taking this medication as prescribed even if you feel||
0089|069|H|well. To help you remember, take it at the same time(s) each day.||
0089|070|H|Do not stop taking this medication without consulting your||
0089|071|H|doctor. Anxiety, agitation, and trouble sleeping can occur if the||
0089|072|H|drug is suddenly stopped.||
0089|073|H|   It may take 2 to 4 weeks before you notice the full effects of||
0089|074|H|this medication. Tell your doctor if your condition lasts or gets||
0089|075|H|worse.||
0089|076|B|||
0089|077|S|SIDE EFFECTS:  See also the Warning section.||
0089|078|S|   Nausea, vomiting, diarrhea, drowsiness, dizziness, tiredness,||
0089|079|S|blurred vision, changes in weight, headache, muscle ache/pain,||
0089|080|S|dry mouth, bad taste in the mouth, stuffy nose, constipation, or||
0089|081|S|change in sexual interest/ability may occur. If any of these||
0089|082|S|effects last or get worse, tell your doctor or pharmacist||
0089|083|S|promptly.||
0089|084|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0089|085|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0089|086|S|substitute.||
0089|087|S|   To reduce the risk of dizziness and lightheadedness, get up||
0089|088|S|slowly when rising from a sitting or lying position.||
0089|089|S|   Remember that this medication has been prescribed because your||
0089|090|S|doctor has judged that the benefit to you is greater than the||
0089|091|S|risk of side effects. Many people using this medication do not||
0089|092|S|have serious side effects.||
0089|093|S|   Tell your doctor right away if you have any serious side||
0089|094|S|effects, including: shaking (tremors), nightmares, ringing in the||
0089|095|S|ears, problems urinating, blood in urine, signs of infection||
0089|096|S|(such as such as sore throat that doesn't go away, fever,||
0089|097|S|chills), shortness of breath, stomach/abdominal pain.||
0089|098|S|   Get medical help right away if you have any very serious side||
0089|099|S|effects, including: chest/jaw/left arm pain, fainting,||
0089|100|S|fast/irregular heartbeat, seizures, eye pain/swelling/redness,||
0089|101|S|widened pupils, vision changes (such as seeing rainbows around||
0089|102|S|lights at night).||
0089|103|S|   This medication may increase serotonin and rarely cause a very||
0089|104|S|serious condition called serotonin syndrome/toxicity. The risk||
0089|105|S|increases if you are also taking other drugs that increase||
0089|106|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0089|107|S|take (see Drug Interactions section). Get medical help right away||
0089|108|S|if you develop some of the following symptoms: fast heartbeat,||
0089|109|S|hallucinations, loss of coordination, severe dizziness, severe||
0089|110|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0089|111|S|unusual agitation/restlessness.||
0089|112|S|   Rarely, males may have a painful or prolonged erection lasting||
0089|113|S|4 or more hours. If this occurs, stop using this drug and get||
0089|114|S|medical help right away, or permanent problems could occur.||
0089|115|S|   A very serious allergic reaction to this drug is rare.||
0089|116|S|However, get medical help right away if you notice any symptoms||
0089|117|S|of a serious allergic reaction, including: rash, itching/swelling||
0089|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0089|119|S|breathing.||
0089|120|S|   This is not a complete list of possible side effects. If you||
0089|121|S|notice other effects not listed above, contact your doctor or||
0089|122|S|pharmacist.||
0089|123|S|   In the US -||
0089|124|S|   Call your doctor for medical advice about side effects. You||
0089|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0089|126|S|www.fda.gov/medwatch.||
0089|127|S|   In Canada - Call your doctor for medical advice about side||
0089|128|S|effects. You may report side effects to Health Canada at||
0089|129|S|1-866-234-2345.||
0089|130|B|||
0089|131|P|PRECAUTIONS:  Before taking trazodone, tell your doctor or||
0089|132|P|pharmacist if you are allergic to it; or to nefazodone; or if you||
0089|133|P|have any other allergies. This product may contain inactive||
0089|134|P|ingredients, which can cause allergic reactions or other||
0089|135|P|problems. Talk to your pharmacist for more details.||
0089|136|P|   Before using this medication, tell your doctor or pharmacist||
0089|137|P|your medical history, especially of: personal or family history||
0089|138|P|of bipolar disorder, personal or family history of suicide||
0089|139|P|attempts, heart disease (such as irregular heartbeat, heart||
0089|140|P|attack), liver disease, kidney disease, blood pressure problems,||
0089|141|P|personal or family history of glaucoma (angle-closure type).||
0089|142|P|   This drug may make you dizzy or drowsy or blur your vision.||
0089|143|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0089|144|P|drowsy. Do not drive, use machinery, or do anything that needs||
0089|145|P|alertness or clear vision until you can do it safely. Limit||
0089|146|P|alcoholic beverages. Talk to your doctor if you are using||
0089|147|P|marijuana (cannabis).||
0089|148|P|   Trazodone may cause a condition that affects the heart rhythm||
0089|149|P|(QT prolongation). QT prolongation can rarely cause serious||
0089|150|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0089|151|P|as severe dizziness, fainting) that need medical attention right||
0089|152|P|away.||
0089|153|P|   The risk of QT prolongation may be increased if you have||
0089|154|P|certain medical conditions or are taking other drugs that may||
0089|155|P|cause QT prolongation. Before using trazodone, tell your doctor||
0089|156|P|or pharmacist of all the drugs you take and if you have any of||
0089|157|P|the following conditions: certain heart problems (heart failure,||
0089|158|P|slow heartbeat, QT prolongation in the EKG), family history of||
0089|159|P|certain heart problems (QT prolongation in the EKG, sudden||
0089|160|P|cardiac death).||
0089|161|P|   Low levels of potassium or magnesium in the blood may also||
0089|162|P|increase your risk of QT prolongation. This risk may increase if||
0089|163|P|you use certain drugs (such as diuretics/"water pills") or if you||
0089|164|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0089|165|P|Talk to your doctor about using trazodone safely.||
0089|166|P|   Before having surgery, tell your doctor or dentist about all||
0089|167|P|the products you use (including prescription drugs,||
0089|168|P|nonprescription drugs, and herbal products).||
0089|169|P|   Older adults may be more sensitive to the side effects of this||
0089|170|P|drug, especially drowsiness, dizziness, and QT prolongation (see||
0089|171|P|above).||
0089|172|P|   During pregnancy, this medication should be used only when||
0089|173|P|clearly needed. Discuss the risks and benefits with your doctor.||
0089|174|P|   Since untreated mental/mood problems (such as depression) can||
0089|175|P|be a serious condition, do not stop taking this medication unless||
0089|176|P|directed by your doctor. If you are planning pregnancy, become||
0089|177|P|pregnant, or think you may be pregnant, immediately discuss with||
0089|178|P|your doctor the benefits and risks of using this medication||
0089|179|P|during pregnancy.||
0089|180|P|   This medication passes into breast milk. Consult your doctor||
0089|181|P|before breastfeeding.||
0089|182|B|||
0089|183|I|DRUG INTERACTIONS:  See also How to Use section.||
0089|184|I|   Drug interactions may change how your medications work or||
0089|185|I|increase your risk for serious side effects. This document does||
0089|186|I|not contain all possible drug interactions. Keep a list of all||
0089|187|I|the products you use (including prescription/nonprescription||
0089|188|I|drugs and herbal products) and share it with your doctor and||
0089|189|I|pharmacist. Do not start, stop, or change the dosage of any||
0089|190|I|medicines without your doctor's approval.||
0089|191|I|   A product that may interact with this drug is: digoxin.||
0089|192|I|   Taking MAO inhibitors with this medication may cause a serious||
0089|193|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0089|194|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0089|195|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0089|196|I|selegiline, tranylcypromine) during treatment with this||
0089|197|I|medication. Most MAO inhibitors should also not be taken for two||
0089|198|I|weeks before and after treatment with this medication. Ask your||
0089|199|I|doctor when to start or stop taking this medication.||
0089|200|I|   Other medications can affect the removal of trazodone from||
0089|201|I|your body, which may affect how trazodone works. Examples include||
0089|202|I|azole antifungals (such as itraconazole, ketoconazole), macrolide||
0089|203|I|antibiotics (such as erythromycin), ritonavir, drugs used to||
0089|204|I|treat seizures (such as phenytoin), among others.||
0089|205|I|   The risk of serotonin syndrome/toxicity increases if you are||
0089|206|I|also taking other drugs that increase serotonin. Examples include||
0089|207|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0089|208|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0089|209|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0089|210|I|serotonin syndrome/toxicity may be more likely when you start or||
0089|211|I|increase the dose of these drugs.||
0089|212|I|   Tell your doctor or pharmacist if you are taking other||
0089|213|I|products that cause drowsiness including alcohol, marijuana||
0089|214|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0089|215|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0089|216|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0089|217|I|codeine).||
0089|218|I|   Check the labels on all your medicines (such as allergy or||
0089|219|I|cough-and-cold products) because they may contain ingredients||
0089|220|I|that cause drowsiness. Ask your pharmacist about using those||
0089|221|I|products safely.||
0089|222|B|||
0089|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0089|224|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0089|225|O|poison control center right away. US residents can call||
0089|226|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0089|227|O|Symptoms of overdose may include: painful/prolonged erection,||
0089|228|O|slow/rapid/irregular heartbeat, unusual drowsiness, unusual||
0089|229|O|dizziness, vomiting, trouble breathing, seizures.||
0089|230|B|||
0089|231|N|NOTES:  Do not share this medication with others.||
0089|232|N|   Lab and/or medical tests should be done while you are taking||
0089|233|N|this medication. Keep all medical and lab appointments. Consult||
0089|234|N|your doctor for more details.||
0089|235|B|||
0089|236|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0089|237|D|remember. If it is near the time of the next dose, skip the||
0089|238|D|missed dose. Take your next dose at the regular time. Do not||
0089|239|D|double the dose to catch up.||
0089|240|B|||
0089|241|R|STORAGE:  Store at room temperature away from light and moisture.||
0089|242|R|Do not store in the bathroom. For the liquid form, once the||
0089|243|R|bottle is opened, this medication expires after 30 days. Keep all||
0089|244|R|medications away from children and pets.||
0089|245|R|   Do not flush medications down the toilet or pour them into a||
0089|246|R|drain unless instructed to do so. Properly discard this product||
0089|247|R|when it is expired or no longer needed. Consult your pharmacist||
0089|248|R|or local waste disposal company.||
0089|249|B|||
0089|250|A|Information last revised April 2025.||
0089|251|A|Copyright(c) 2025 First Databank, Inc.||
0089|252|B|||
0090|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0090|002|Z|does NOT have all possible information about this product. This||
0090|003|Z|information does not assure that this product is safe, effective,||
0090|004|Z|or appropriate for you. This information is not individual||
0090|005|Z|medical advice and does not substitute for the advice of your||
0090|006|Z|health care professional. Always ask your health care||
0090|007|Z|professional for complete information about this product and your||
0090|008|Z|specific health needs.||
0090|009|B|||
0090|010|T|METOCLOPRAMIDE - ORAL||
0090|011|F|(MET-oh-KLOE-pra-mide)||
0090|012|B|||
0090|013|C|COMMON BRAND NAME(S): Reglan||
0090|014|B|||
0090|015|W|WARNING:  This medication may cause a serious movement disorder||
0090|016|W|called tardive dyskinesia. In some cases, this condition may be||
0090|017|W|permanent. The risk of tardive dyskinesia is increased with the||
0090|018|W|longer use of the medication and the more medication that you||
0090|019|W|take. The risk is also increased in older adults (especially||
0090|020|W|women) and in people with diabetes. Metoclopramide comes in||
0090|021|W|different forms (such as tablets, solution, injection). Do not||
0090|022|W|use metoclopramide products for longer than 12 weeks. Talk to||
0090|023|W|your doctor about the risks and benefits of this medication.||
0090|024|W|   Tell your doctor right away if you develop any unusual||
0090|025|W|uncontrolled movements (especially of the face, mouth, tongue,||
0090|026|W|arms or legs). There is no treatment for tardive dyskinesia, but||
0090|027|W|in some cases the symptoms may lessen or stop once metoclopramide||
0090|028|W|is stopped.||
0090|029|B|||
0090|030|U|USES:  This medication is used to treat certain conditions of the||
0090|031|U|stomach and intestines. Metoclopramide is used as a short-term||
0090|032|U|treatment (4 to 12 weeks) for ongoing heartburn when the usual||
0090|033|U|medicines do not work well enough. It is used mostly for||
0090|034|U|heartburn that occurs after a meal or during the daytime.||
0090|035|U|Treating ongoing heartburn can decrease the damage done by||
0090|036|U|stomach acid to the swallowing tube (esophagus) and help healing.||
0090|037|U|   Metoclopramide is also used in diabetic patients who have poor||
0090|038|U|emptying of their stomachs (gastroparesis). Treating||
0090|039|U|gastroparesis can decrease symptoms of nausea, vomiting, and||
0090|040|U|stomach/abdominal fullness. Metoclopramide works by blocking a||
0090|041|U|natural substance (dopamine). It speeds up stomach emptying and||
0090|042|U|movement of the upper intestines.||
0090|043|U|   This drug is not recommended for use in children due to an||
0090|044|U|increased risk of serious side effects (such as muscle||
0090|045|U|spasms/uncontrolled muscle movements). Ask the doctor or||
0090|046|U|pharmacist for details.||
0090|047|B|||
0090|048|V|OTHER USES:  This section contains uses of this drug that are not||
0090|049|V|listed in the approved professional labeling for the drug but||
0090|050|V|that may be prescribed by your health care professional. Use this||
0090|051|V|drug for a condition that is listed in this section only if it||
0090|052|V|has been so prescribed by your health care professional.||
0090|053|V|   This drug may also be used to reduce the risk of||
0090|054|V|nausea/vomiting from chemotherapy or radiation treatments for||
0090|055|V|cancer.||
0090|056|B|||
0090|057|H|HOW TO USE:  See also Warning section.||
0090|058|H|   Read the Medication Guide provided by your pharmacist before||
0090|059|H|you start taking metoclopramide and each time you get a refill.||
0090|060|H|If you have any questions, consult your doctor or pharmacist.||
0090|061|H|   Take this medication by mouth as directed by your doctor,||
0090|062|H|usually up to 4 times daily (30 minutes before meals and at||
0090|063|H|bedtime). If you are using the liquid form of this medication,||
0090|064|H|carefully measure the dose using a special measuring||
0090|065|H|device/spoon. Do not use a household spoon because you may not||
0090|066|H|get the correct dose.||
0090|067|H|   The dosage is based on your medical condition, response to||
0090|068|H|treatment, age, and other medications you may be taking. Be sure||
0090|069|H|to tell your doctor and pharmacist about all the products you use||
0090|070|H|(including prescription drugs, nonprescription drugs, and herbal||
0090|071|H|products).||
0090|072|H|   Because of the risk of tardive dyskinesia, do not take this||
0090|073|H|more often, in larger doses, or for longer than directed by your||
0090|074|H|doctor.||
0090|075|H|   If heartburn only occurs at certain times (such as after the||
0090|076|H|evening meal), your doctor may direct you to take a single dose||
0090|077|H|before those times instead of taking it throughout the day. This||
0090|078|H|will reduce your risk of side effects.||
0090|079|H|   To treat diabetic gastroparesis, this medication is usually||
0090|080|H|taken for 2 to 8 weeks until your gut is working well. This||
0090|081|H|condition may recur from time to time. Your doctor may direct you||
0090|082|H|to start taking this medication as soon as your symptoms reappear||
0090|083|H|and stop when you feel better. Ask your doctor for directions for||
0090|084|H|starting and stopping this medication.||
0090|085|H|   Take this medication regularly as directed to get the most||
0090|086|H|benefit from it. To help you remember, take it at the same times||
0090|087|H|before a meal each day.||
0090|088|H|   If you suddenly stop using this medication, you may have||
0090|089|H|withdrawal symptoms (such as dizziness, nervousness, headaches).||
0090|090|H|To help prevent withdrawal, your doctor may lower your dose||
0090|091|H|slowly. Withdrawal is more likely if you have used metoclopramide||
0090|092|H|for a long time or in high doses. Tell your doctor or pharmacist||
0090|093|H|right away if you have withdrawal.||
0090|094|H|   Tell your doctor if your condition lasts or gets worse.||
0090|095|B|||
0090|096|S|SIDE EFFECTS:  See also Warning section.||
0090|097|S|   Drowsiness, dizziness, tiredness, trouble sleeping, agitation,||
0090|098|S|headache, and diarrhea may occur. If any of these effects last or||
0090|099|S|get worse, tell your doctor or pharmacist promptly.||
0090|100|S|   Remember that this medication has been prescribed because your||
0090|101|S|doctor has judged that the benefit to you is greater than the||
0090|102|S|risk of side effects. Many people using this medication do not||
0090|103|S|have serious side effects.||
0090|104|S|   This medication may raise your blood pressure. Check your||
0090|105|S|blood pressure regularly and tell your doctor if the results are||
0090|106|S|high.||
0090|107|S|   Tell your doctor right away if you have any serious side||
0090|108|S|effects, including: mental/mood changes (such as anxiety,||
0090|109|S|confusion, depression, thoughts of suicide), decreased sexual||
0090|110|S|ability, inability to keep still/need to pace, muscle||
0090|111|S|spasms/uncontrolled muscle movements (such as twisting neck,||
0090|112|S|arching back), Parkinson-like symptoms (such as shaking,||
0090|113|S|slowed/difficult movement, mask-like facial expression), abnormal||
0090|114|S|breast-milk production, enlarged/tender breasts, swelling of the||
0090|115|S|hands/feet, changes in menstruation in women.||
0090|116|S|   This medication may rarely cause a very serious condition||
0090|117|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0090|118|S|right away if you have any of the following symptoms: fever,||
0090|119|S|muscle stiffness, severe confusion, sweating, fast/irregular||
0090|120|S|heartbeat.||
0090|121|S|   A very serious allergic reaction to this drug is rare.||
0090|122|S|However, get medical help right away if you notice any symptoms||
0090|123|S|of a serious allergic reaction, including: rash, itching/swelling||
0090|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0090|125|S|breathing.||
0090|126|S|   This is not a complete list of possible side effects. If you||
0090|127|S|notice other effects not listed above, contact your doctor or||
0090|128|S|pharmacist.||
0090|129|S|   In the US -||
0090|130|S|   Call your doctor for medical advice about side effects. You||
0090|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0090|132|S|www.fda.gov/medwatch.||
0090|133|S|   In Canada - Call your doctor for medical advice about side||
0090|134|S|effects. You may report side effects to Health Canada at||
0090|135|S|1-866-234-2345.||
0090|136|B|||
0090|137|P|PRECAUTIONS:  Before taking metoclopramide, tell your doctor or||
0090|138|P|pharmacist if you are allergic to it; or if you have any other||
0090|139|P|allergies. This product may contain inactive ingredients, which||
0090|140|P|can cause allergic reactions or other problems. Talk to your||
0090|141|P|pharmacist for more details.||
0090|142|P|   Before taking this medication, tell your doctor or pharmacist||
0090|143|P|your medical history, especially of: history of movement/muscle||
0090|144|P|disorders (such as tardive dyskinesia, dystonia) caused by a||
0090|145|P|medication, bleeding/blockage/hole in the intestines/stomach,||
0090|146|P|breast cancer, high blood pressure, kidney problems, heart||
0090|147|P|failure, mental/mood problems (such as depression, thoughts of||
0090|148|P|suicide), Parkinson's disease, liver problems (such as cirrhosis,||
0090|149|P|porphyria), a certain adrenal gland tumor (pheochromocytoma),||
0090|150|P|seizures, a certain blood enzyme problem (NADH-cytochrome b5||
0090|151|P|reductase deficiency).||
0090|152|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0090|153|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0090|154|P|machinery, or do anything that needs alertness until you can do||
0090|155|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0090|156|P|are using marijuana (cannabis).||
0090|157|P|   Liquid products may contain alcohol. Caution is advised if you||
0090|158|P|have diabetes, alcohol dependence, liver disease, or any other||
0090|159|P|condition that requires you to limit alcohol. Ask your doctor or||
0090|160|P|pharmacist about using this product safely.||
0090|161|P|   Before having surgery, tell your doctor or dentist about all||
0090|162|P|the products you use (including prescription drugs,||
0090|163|P|nonprescription drugs, and herbal products).||
0090|164|P|   If you have diabetes, this product may make it harder to||
0090|165|P|control your blood sugar. Check your blood sugar regularly as||
0090|166|P|directed and share the results with your doctor. Tell your doctor||
0090|167|P|right away if you have high or low blood sugar. Your doctor may||
0090|168|P|need to adjust your diabetes medication, exercise program, or||
0090|169|P|diet.||
0090|170|P|   Children may be more sensitive to the side effects of this||
0090|171|P|drug, especially muscle spasms/uncontrolled muscle movements. See||
0090|172|P|also Uses section.||
0090|173|P|   Older adults may be more sensitive to the effects of this||
0090|174|P|drug, especially drowsiness, tardive dyskinesia, and Parkinson's||
0090|175|P|type muscle problems. Drowsiness can increase the risk of||
0090|176|P|falling.||
0090|177|P|   During pregnancy, this medication should be used only when||
0090|178|P|clearly needed. Discuss the risks and benefits with your doctor.||
0090|179|P|   This drug passes into breast milk and may have undesirable||
0090|180|P|effects on a nursing infant. Consult your doctor before||
0090|181|P|breastfeeding.||
0090|182|B|||
0090|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0090|184|I|medications work or increase your risk for serious side effects.||
0090|185|I|This document does not contain all possible drug interactions.||
0090|186|I|Keep a list of all the products you use (including||
0090|187|I|prescription/nonprescription drugs and herbal products) and share||
0090|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
0090|189|I|the dosage of any medicines without your doctor's approval.||
0090|190|I|   Some products that may interact with this drug include:||
0090|191|I|antipsychotic drugs (such as aripiprazole, haloperidol),||
0090|192|I|atovaquone, dopamine agonists (such as cabergoline, pergolide,||
0090|193|I|ropinirole), fosfomycin, MAO inhibitors (isocarboxazid,||
0090|194|I|linezolid, metaxalone, methylene blue, moclobemide, phenelzine,||
0090|195|I|procarbazine, rasagiline, safinamide, selegiline,||
0090|196|I|tranylcypromine), pramlintide, phenothiazines (such as||
0090|197|I|promethazine, prochlorperazine), rivastigmine.||
0090|198|I|   Metoclopramide causes food and medication to move through your||
0090|199|I|stomach more quickly, which may affect the absorption of some||
0090|200|I|drugs. Talk to your doctor or pharmacist to see if any of the||
0090|201|I|drugs that you are taking may be affected.||
0090|202|I|   Tell your doctor or pharmacist if you are taking other||
0090|203|I|products that cause drowsiness, including alcohol, marijuana||
0090|204|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0090|205|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0090|206|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0090|207|I|codeine).||
0090|208|I|   Check the labels on all your medicines (such as allergy or||
0090|209|I|cough-and-cold products) because they may contain ingredients||
0090|210|I|that cause drowsiness. Ask your pharmacist about using those||
0090|211|I|products safely.||
0090|212|B|||
0090|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0090|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0090|215|O|poison control center right away. US residents can call||
0090|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0090|217|B|||
0090|218|N|NOTES:  Do not share this medication with others.||
0090|219|N|   Lab and/or medical tests (such as endoscopy for ulcer) may be||
0090|220|N|done while you are taking this medication. Keep all medical and||
0090|221|N|lab appointments. Consult your doctor for more details.||
0090|222|B|||
0090|223|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0090|224|D|remember. If it is near the time of the next dose, skip the||
0090|225|D|missed dose. Take your next dose at the regular time. Do not||
0090|226|D|double the dose to catch up.||
0090|227|B|||
0090|228|R|STORAGE:  Store at room temperature away from light and moisture.||
0090|229|R|Do not store in the bathroom. Keep all medications away from||
0090|230|R|children and pets.||
0090|231|R|   Do not flush medications down the toilet or pour them into a||
0090|232|R|drain unless instructed to do so. Properly discard this product||
0090|233|R|when it is expired or no longer needed. Consult your pharmacist||
0090|234|R|or local waste disposal company.||
0090|235|B|||
0090|236|A|Information last revised August 2024.||
0090|237|A|Copyright(c) 2025 First Databank, Inc.||
0090|238|B|||
0091|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0091|002|Z|does NOT have all possible information about this product. This||
0091|003|Z|information does not assure that this product is safe, effective,||
0091|004|Z|or appropriate for you. This information is not individual||
0091|005|Z|medical advice and does not substitute for the advice of your||
0091|006|Z|health care professional. Always ask your health care||
0091|007|Z|professional for complete information about this product and your||
0091|008|Z|specific health needs.||
0091|009|B|||
0091|010|T|MUPIROCIN OINTMENT - TOPICAL||
0091|011|F|(mue-PIR-oh-sin)||
0091|012|B|||
0091|013|C|COMMON BRAND NAME(S): Bactroban||
0091|014|B|||
0091|015|U|USES:  Mupirocin is used to treat certain skin infections (such||
0091|016|U|as impetigo). It is an antibiotic. It works by stopping the||
0091|017|U|growth of certain bacteria.||
0091|018|B|||
0091|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0091|020|H|from your pharmacist before you start using mupirocin and each||
0091|021|H|time you get a refill. If you have any questions, ask your doctor||
0091|022|H|or pharmacist.||
0091|023|H|   Use this medication only on the skin. Clean and dry the||
0091|024|H|affected area first. Then apply a small amount of ointment to the||
0091|025|H|area as directed by your doctor, usually 3 times a day. You may||
0091|026|H|cover the treated area with a bandage.||
0091|027|H|   Use this medication regularly to get the most benefit from it.||
0091|028|H|Continue to use it for the full time prescribed, even if symptoms||
0091|029|H|disappear after a few days. Stopping the medication too early may||
0091|030|H|result in a return of the infection.||
0091|031|H|   Avoid using this medication around your eyes, nose, mouth, or||
0091|032|H|on large areas of damaged or broken skin unless otherwise||
0091|033|H|directed by your doctor. If you accidentally get it in your eyes,||
0091|034|H|nose, or mouth, rinse well with plenty of water.||
0091|035|H|   Tell your doctor if your condition does not get better in 3 to||
0091|036|H|5 days.||
0091|037|B|||
0091|038|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0091|039|S|because your doctor has judged that the benefit to you is greater||
0091|040|S|than the risk of side effects. Many people using this medication||
0091|041|S|do not have serious side effects.||
0091|042|S|   Although uncommon, mild burning or stinging after using this||
0091|043|S|medication may occur. If you have severe burning, stinging, or||
0091|044|S|irritation, stop using this medication and tell your doctor right||
0091|045|S|away.||
0091|046|S|   This medication may rarely cause a severe intestinal condition||
0091|047|S|due to a bacteria called C. difficile. This condition may occur||
0091|048|S|during treatment or weeks to months after treatment has stopped.||
0091|049|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0091|050|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0091|051|S|stool.||
0091|052|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0091|053|S|products because they may make symptoms worse.||
0091|054|S|   Use of this medication for prolonged or repeated periods may||
0091|055|S|result in a new skin infection caused by fungus or yeast. Tell||
0091|056|S|your doctor right away if you notice signs of a new infection, or||
0091|057|S|if your current infection does not get better or if it gets||
0091|058|S|worse.||
0091|059|S|   A very serious allergic reaction to this drug is rare.||
0091|060|S|However, get medical help right away if you notice any symptoms||
0091|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0091|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0091|063|S|breathing.||
0091|064|S|   This is not a complete list of possible side effects. If you||
0091|065|S|notice other effects not listed above, contact your doctor or||
0091|066|S|pharmacist.||
0091|067|S|   In the US -||
0091|068|S|   Call your doctor for medical advice about side effects. You||
0091|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0091|070|S|www.fda.gov/medwatch.||
0091|071|S|   In Canada - Call your doctor for medical advice about side||
0091|072|S|effects. You may report side effects to Health Canada at||
0091|073|S|1-866-234-2345.||
0091|074|B|||
0091|075|P|PRECAUTIONS:  Before using mupirocin, tell your doctor or||
0091|076|P|pharmacist if you are allergic to it; or if you have any other||
0091|077|P|allergies. This product may contain inactive ingredients (such as||
0091|078|P|polyethylene glycol found in some brands), which can cause||
0091|079|P|allergic reactions or other problems. Talk to your pharmacist for||
0091|080|P|more details.||
0091|081|P|   Before using this medication, tell your doctor or pharmacist||
0091|082|P|your medical history, especially of: kidney disease (if you are||
0091|083|P|using a brand of mupirocin that contains polyethylene glycol).||
0091|084|P|   Before having surgery, tell your doctor or dentist about all||
0091|085|P|the products you use (including prescription drugs,||
0091|086|P|nonprescription drugs, and herbal products).||
0091|087|P|   During pregnancy, this medication should be used only when||
0091|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
0091|089|P|   It is unknown if this drug passes into breast milk. Consult||
0091|090|P|your doctor before breastfeeding.||
0091|091|B|||
0091|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0091|093|I|medications work or increase your risk for serious side effects.||
0091|094|I|This document does not contain all possible drug interactions.||
0091|095|I|Keep a list of all the products you use (including||
0091|096|I|prescription/nonprescription drugs and herbal products) and share||
0091|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
0091|098|I|the dosage of any medicines without your doctor's approval.||
0091|099|B|||
0091|100|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0091|101|O|has overdosed and has serious symptoms such as passing out or||
0091|102|O|trouble breathing, call 911. Otherwise, call a poison control||
0091|103|O|center right away. US residents can call 1-800-222-1222. Canada||
0091|104|O|residents can call 1-844-764-7669.||
0091|105|B|||
0091|106|N|NOTES:  Do not share this medication with others.||
0091|107|N|   This medication has been prescribed for your current condition||
0091|108|N|only. Do not use it later for another infection unless your||
0091|109|N|doctor tells you to.||
0091|110|B|||
0091|111|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0091|112|D|If it is near the time of the next dose, skip the missed dose.||
0091|113|D|Use your next dose at the regular time. Do not double the dose to||
0091|114|D|catch up.||
0091|115|B|||
0091|116|R|STORAGE:  Store at room temperature. Keep all medications away||
0091|117|R|from children and pets.||
0091|118|R|   Do not flush medications down the toilet or pour them into a||
0091|119|R|drain unless instructed to do so. Properly discard this product||
0091|120|R|when it is expired or no longer needed. Consult your pharmacist||
0091|121|R|or local waste disposal company.||
0091|122|B|||
0091|123|A|Information last revised May 2024.||
0091|124|A|Copyright(c) 2025 First Databank, Inc.||
0091|125|B|||
0092|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0092|002|Z|does NOT have all possible information about this product. This||
0092|003|Z|information does not assure that this product is safe, effective,||
0092|004|Z|or appropriate for you. This information is not individual||
0092|005|Z|medical advice and does not substitute for the advice of your||
0092|006|Z|health care professional. Always ask your health care||
0092|007|Z|professional for complete information about this product and your||
0092|008|Z|specific health needs.||
0092|009|B|||
0092|010|T|LOVASTATIN - ORAL||
0092|011|F|(LOE-va-STAT-in)||
0092|012|B|||
0092|013|C|COMMON BRAND NAME(S): Mevacor||
0092|014|B|||
0092|015|U|USES:  Lovastatin is used along with a proper diet to help lower||
0092|016|U|"bad" cholesterol and fats (such as LDL, triglycerides) and raise||
0092|017|U|"good" cholesterol (HDL) in the blood. It belongs to a group of||
0092|018|U|drugs known as "statins." It works by reducing the amount of||
0092|019|U|cholesterol made by the liver. Lowering "bad" cholesterol and||
0092|020|U|triglycerides and raising "good" cholesterol decreases the risk||
0092|021|U|of heart disease and helps prevent strokes and heart attacks.||
0092|022|U|   In addition to eating a proper diet (such as a||
0092|023|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
0092|024|U|help this medication work better include exercising, losing||
0092|025|U|weight if overweight, and stopping smoking. Consult your doctor||
0092|026|U|for more details.||
0092|027|B|||
0092|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
0092|029|H|doctor, usually once daily with your evening meal. Some patients||
0092|030|H|may be directed to take this medication twice daily.||
0092|031|H|   Dosage is based on your medical condition, response to||
0092|032|H|treatment, age, and other medications you may be taking. Be sure||
0092|033|H|to tell your doctor and pharmacist about all the products you use||
0092|034|H|(including prescription drugs, nonprescription drugs, and herbal||
0092|035|H|products).||
0092|036|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0092|037|H|using this medication unless your doctor or pharmacist says you||
0092|038|H|may do so safely. Grapefruit can increase the chance of side||
0092|039|H|effects with this medicine. Ask your doctor or pharmacist for||
0092|040|H|more details.||
0092|041|H|   If you also take certain other drugs to lower your cholesterol||
0092|042|H|(bile acid-binding resins such as cholestyramine or colestipol),||
0092|043|H|take lovastatin at least 1 hour before or at least 4 hours after||
0092|044|H|taking these medications. These products can react with||
0092|045|H|lovastatin, preventing its full absorption.||
0092|046|H|   Take this medication regularly in order to get the most||
0092|047|H|benefit from it. Remember to take it at the same time(s) each||
0092|048|H|day. Keep taking this medication even if you feel well. Most||
0092|049|H|people with high cholesterol or triglycerides do not feel sick.||
0092|050|H|   It is very important to continue to follow your doctor's||
0092|051|H|advice about diet and exercise. It may take up to 4 weeks before||
0092|052|H|you get the full benefit of this drug.||
0092|053|B|||
0092|054|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0092|055|S|because your doctor has judged that the benefit to you is greater||
0092|056|S|than the risk of side effects. Many people using this medication||
0092|057|S|do not have serious side effects.||
0092|058|S|   A very small number of people taking lovastatin may have mild||
0092|059|S|memory problems or confusion. If these rare effects occur, talk||
0092|060|S|to your doctor.||
0092|061|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
0092|062|S|doctor about the benefits and risks.||
0092|063|S|   This drug may rarely cause muscle problems (which can rarely||
0092|064|S|lead to very serious conditions called rhabdomyolysis and||
0092|065|S|autoimmune myopathy). Tell your doctor right away if you develop||
0092|066|S|any of these symptoms during treatment and if these symptoms last||
0092|067|S|after your doctor stops this drug: muscle||
0092|068|S|pain/tenderness/weakness (especially with fever or unusual||
0092|069|S|tiredness), signs of kidney problems (such as change in the||
0092|070|S|amount of urine).||
0092|071|S|   This medication may rarely cause liver problems. Tell your||
0092|072|S|doctor right away if you develop symptoms of liver problems,||
0092|073|S|including: nausea/vomiting that doesn't stop, yellowing||
0092|074|S|eyes/skin, dark urine, stomach/abdominal pain.||
0092|075|S|   A very serious allergic reaction to this drug is rare.||
0092|076|S|However, get medical help right away if you notice any symptoms||
0092|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0092|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0092|079|S|breathing.||
0092|080|S|   This is not a complete list of possible side effects. If you||
0092|081|S|notice other effects not listed above, contact your doctor or||
0092|082|S|pharmacist.||
0092|083|S|   In the US -||
0092|084|S|   Call your doctor for medical advice about side effects. You||
0092|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0092|086|S|www.fda.gov/medwatch.||
0092|087|S|   In Canada - Call your doctor for medical advice about side||
0092|088|S|effects. You may report side effects to Health Canada at||
0092|089|S|1-866-234-2345.||
0092|090|B|||
0092|091|P|PRECAUTIONS:  Before taking lovastatin, tell your doctor or||
0092|092|P|pharmacist if you are allergic to it; or if you have any other||
0092|093|P|allergies. This product may contain inactive ingredients, which||
0092|094|P|can cause allergic reactions or other problems. Talk to your||
0092|095|P|pharmacist for more details.||
0092|096|P|   Before using this medication, tell your doctor or pharmacist||
0092|097|P|your medical history, especially of: liver disease, kidney||
0092|098|P|disease, alcohol use.||
0092|099|P|   Before having surgery, tell your doctor or dentist about all||
0092|100|P|the products you use (including prescription drugs,||
0092|101|P|nonprescription drugs, and herbal products).||
0092|102|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
0092|103|P|your risk for liver problems, especially when combined with||
0092|104|P|lovastatin. Ask your doctor or pharmacist for more information.||
0092|105|P|   Older adults may be more sensitive to the side effects of this||
0092|106|P|drug, especially muscle problems.||
0092|107|P|   During pregnancy, this medication should be used only when||
0092|108|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0092|109|P|benefits with your doctor.||
0092|110|P|   It is unknown if this medication passes into breast milk.||
0092|111|P|Because of the possible risk to the infant, breastfeeding is not||
0092|112|P|recommended while using this medication. Consult your doctor||
0092|113|P|before breastfeeding.||
0092|114|B|||
0092|115|I|DRUG INTERACTIONS:  See also How to Use section.||
0092|116|I|   Drug interactions may change how your medications work or||
0092|117|I|increase your risk for serious side effects. This document does||
0092|118|I|not contain all possible drug interactions. Keep a list of all||
0092|119|I|the products you use (including prescription/nonprescription||
0092|120|I|drugs and herbal products) and share it with your doctor and||
0092|121|I|pharmacist. Do not start, stop, or change the dosage of any||
0092|122|I|medicines without your doctor's approval.||
0092|123|I|   Some products that may interact with this drug include: "blood||
0092|124|I|thinners" (such as warfarin), daptomycin, gemfibrozil.||
0092|125|I|   Other medications can affect the removal of lovastatin from||
0092|126|I|your body, which may affect how lovastatin works. Examples||
0092|127|I|include certain azole antifungals (such as itraconazole,||
0092|128|I|ketoconazole, posaconazole, voriconazole), cobicistat,||
0092|129|I|colchicine, cyclosporine, macrolide antibiotics (such as||
0092|130|I|clarithromycin, erythromycin), nefazodone, HIV protease||
0092|131|I|inhibitors (such as lopinavir), ritonavir, telithromycin, among||
0092|132|I|others.||
0092|133|I|   Do not take any red yeast rice products while you are taking||
0092|134|I|lovastatin since those products may also contain lovastatin.||
0092|135|I|Taking lovastatin and red yeast rice products together can||
0092|136|I|increase your risk of serious muscle and liver problems.||
0092|137|B|||
0092|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0092|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0092|140|O|poison control center right away. US residents can call||
0092|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0092|142|B|||
0092|143|N|NOTES:  Do not share this medication with others.||
0092|144|N|   Lab and/or medical tests (such as blood||
0092|145|N|cholesterol/triglyceride levels, liver function) should be done||
0092|146|N|while you are taking this medication. Keep all medical and lab||
0092|147|N|appointments. Consult your doctor for more details.||
0092|148|B|||
0092|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0092|150|D|remember. If it is near the time of the next dose, skip the||
0092|151|D|missed dose. Take your next dose at the regular time. Do not||
0092|152|D|double the dose to catch up.||
0092|153|B|||
0092|154|R|STORAGE:  Store at room temperature away from light and moisture.||
0092|155|R|Do not store in the bathroom. Keep all medications away from||
0092|156|R|children and pets.||
0092|157|R|   Do not flush medications down the toilet or pour them into a||
0092|158|R|drain unless instructed to do so. Properly discard this product||
0092|159|R|when it is expired or no longer needed. Consult your pharmacist||
0092|160|R|or local waste disposal company.||
0092|161|B|||
0092|162|A|Information last revised May 2024.||
0092|163|A|Copyright(c) 2025 First Databank, Inc.||
0092|164|B|||
0093|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0093|002|Z|does NOT have all possible information about this product. This||
0093|003|Z|information does not assure that this product is safe, effective,||
0093|004|Z|or appropriate for you. This information is not individual||
0093|005|Z|medical advice and does not substitute for the advice of your||
0093|006|Z|health care professional. Always ask your health care||
0093|007|Z|professional for complete information about this product and your||
0093|008|Z|specific health needs.||
0093|009|B|||
0093|010|T|CIPROFLOXACIN - ORAL||
0093|011|F|(SIP-roe-FLOX-a-sin)||
0093|012|B|||
0093|013|C|COMMON BRAND NAME(S): Cipro||
0093|014|B|||
0093|015|W|WARNING:  Quinolone antibiotics (including ciprofloxacin) may||
0093|016|W|cause serious and possibly permanent tendon damage (such as||
0093|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
0093|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
0093|019|W|help right away if you have any of the following symptoms:||
0093|020|W|pain/numbness/burning/tingling/weakness in your||
0093|021|W|arms/hands/legs/feet, changes in how you sense||
0093|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
0093|023|W|headache, vision changes, shaking (tremors), seizures,||
0093|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
0093|025|W|hallucinations, depression, rare thoughts of suicide).||
0093|026|W|   Tendon damage may occur during or after treatment with this||
0093|027|W|medication. Stop exercising, rest, and get medical help right||
0093|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
0093|029|W|risk for tendon problems is greater if you are over 60 years of||
0093|030|W|age, if you are taking corticosteroids (such as prednisone), or||
0093|031|W|if you have a kidney, heart, or lung transplant.||
0093|032|W|   This medication may make a certain muscle condition||
0093|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
0093|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
0093|035|W|unsteady walk) or trouble breathing.||
0093|036|W|   Discuss the risks and benefits with your doctor before using||
0093|037|W|this medication.||
0093|038|B|||
0093|039|U|USES:  This medication is used to treat a variety of bacterial||
0093|040|U|infections. Ciprofloxacin belongs to a class of drugs called||
0093|041|U|quinolone antibiotics. It works by stopping the growth of||
0093|042|U|bacteria.||
0093|043|U|   This antibiotic treats only bacterial infections. It will not||
0093|044|U|work for virus infections (such as common cold, flu). Using any||
0093|045|U|antibiotic when it is not needed can cause it to not work for||
0093|046|U|future infections.||
0093|047|B|||
0093|048|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0093|049|H|Patient Information Leaflet provided by your pharmacist before||
0093|050|H|you start taking ciprofloxacin and each time you get a refill. If||
0093|051|H|you have any questions, ask your doctor or pharmacist.||
0093|052|H|   Take this medication by mouth with or without food as directed||
0093|053|H|by your doctor, usually twice a day (every 12 hours).||
0093|054|H|   The tablet may have a bitter taste if you chew or crush it||
0093|055|H|before taking it. Do not split the tablets unless they have a||
0093|056|H|score line and your doctor or pharmacist tells you to do so. The||
0093|057|H|manufacturer recommends swallowing the whole or split tablet||
0093|058|H|without crushing or chewing.||
0093|059|H|   The dosage and length of treatment is based on your medical||
0093|060|H|condition and response to treatment. Drink plenty of fluids while||
0093|061|H|taking this medication unless your doctor tells you otherwise.||
0093|062|H|   Take this medication at least 2 hours before or 6 hours after||
0093|063|H|taking other products that may bind to it, decreasing its||
0093|064|H|effectiveness. Ask your pharmacist about the other products you||
0093|065|H|take. Some examples include: quinapril, sevelamer, sucralfate,||
0093|066|H|vitamins/minerals (including iron and zinc supplements), and||
0093|067|H|products containing magnesium, aluminum, or calcium (such as||
0093|068|H|antacids, calcium supplements).||
0093|069|H|   Calcium-rich foods, including dairy products (such as milk,||
0093|070|H|yogurt) or juice with added calcium, can also decrease the effect||
0093|071|H|of this medication. Take this medication at least 2 hours before||
0093|072|H|or 6 hours after eating calcium-rich foods, unless you are eating||
0093|073|H|these foods as part of a larger meal that contains other||
0093|074|H|(non-calcium-rich) foods. These other foods decrease the calcium||
0093|075|H|binding effect.||
0093|076|H|   Ciprofloxacin may increase and/or prolong the effects of||
0093|077|H|caffeine. Avoid drinking large amounts of beverages containing||
0093|078|H|caffeine (coffee, tea, colas), eating large amounts of chocolate,||
0093|079|H|or taking nonprescription products that contain caffeine.||
0093|080|H|   Ask your doctor or pharmacist about safely using nutritional||
0093|081|H|supplements/replacements with this medication.||
0093|082|H|   For the best effect, take this antibiotic at evenly spaced||
0093|083|H|times. To help you remember, take this medication at the same||
0093|084|H|time(s) every day.||
0093|085|H|   Continue to take this medication until the full prescribed||
0093|086|H|amount is finished, even if symptoms disappear after a few days.||
0093|087|H|Stopping the medication too early may result in a return of the||
0093|088|H|infection.||
0093|089|H|   Tell your doctor if your condition lasts or gets worse.||
0093|090|B|||
0093|091|S|SIDE EFFECTS:  See also Warning section.||
0093|092|S|   Nausea, diarrhea, dizziness, lightheadedness, headache, and||
0093|093|S|trouble sleeping may occur. If any of these effects last or get||
0093|094|S|worse, tell your doctor or pharmacist promptly.||
0093|095|S|   Remember that this medication has been prescribed because your||
0093|096|S|doctor has judged that the benefit to you is greater than the||
0093|097|S|risk of side effects. Many people using this medication do not||
0093|098|S|have serious side effects.||
0093|099|S|   Tell your doctor right away if you have any serious side||
0093|100|S|effects, including: unusual bruising/bleeding, signs of a new||
0093|101|S|infection (such as sore throat that doesn't go away, fever),||
0093|102|S|signs of kidney problems (such as change in the amount of urine,||
0093|103|S|red/pink urine), signs of liver problems (such as nausea/vomiting||
0093|104|S|that doesn't stop, unusual tiredness, stomach/abdominal pain,||
0093|105|S|yellowing eyes/skin, dark urine).||
0093|106|S|   Get medical help right away if you have any very serious side||
0093|107|S|effects, including: severe dizziness, fainting, fast/irregular||
0093|108|S|heartbeat, signs of a tear/break in the main blood vessel called||
0093|109|S|the aorta (such as sudden/severe pain in the stomach/chest/back,||
0093|110|S|shortness of breath).||
0093|111|S|   This medication may rarely cause a severe intestinal condition||
0093|112|S|due to a bacteria called C. difficile. This condition may occur||
0093|113|S|during treatment or weeks to months after treatment has stopped.||
0093|114|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0093|115|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0093|116|S|stool.||
0093|117|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0093|118|S|products because they may make symptoms worse.||
0093|119|S|   Use of this medication for prolonged or repeated periods may||
0093|120|S|result in oral thrush or a new yeast infection. Contact your||
0093|121|S|doctor if you notice white patches in your mouth, a change in||
0093|122|S|vaginal discharge, or other new symptoms.||
0093|123|S|   A very serious allergic reaction to this drug is rare.||
0093|124|S|However, get medical help right away if you notice any symptoms||
0093|125|S|of a serious allergic reaction, including: rash, itching/swelling||
0093|126|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0093|127|S|breathing.||
0093|128|S|   This is not a complete list of possible side effects. If you||
0093|129|S|notice other effects not listed above, contact your doctor or||
0093|130|S|pharmacist.||
0093|131|S|   In the US -||
0093|132|S|   Call your doctor for medical advice about side effects. You||
0093|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0093|134|S|www.fda.gov/medwatch.||
0093|135|S|   In Canada - Call your doctor for medical advice about side||
0093|136|S|effects. You may report side effects to Health Canada at||
0093|137|S|1-866-234-2345.||
0093|138|B|||
0093|139|P|PRECAUTIONS:  Before taking ciprofloxacin, tell your doctor or||
0093|140|P|pharmacist if you are allergic to it; or to other quinolone||
0093|141|P|antibiotics such as norfloxacin, gemifloxacin, levofloxacin,||
0093|142|P|moxifloxacin, or ofloxacin; or if you have any other allergies.||
0093|143|P|This product may contain inactive ingredients, which can cause||
0093|144|P|allergic reactions or other problems. Talk to your pharmacist for||
0093|145|P|more details.||
0093|146|P|   Before using this medication, tell your doctor or pharmacist||
0093|147|P|your medical history, especially of: diabetes, heart problems||
0093|148|P|(such as recent heart attack), joint/tendon problems (such as||
0093|149|P|tendonitis, bursitis), kidney disease, liver disease, mental/mood||
0093|150|P|disorders (such as depression), myasthenia gravis, nerve problems||
0093|151|P|(such as peripheral neuropathy), seizures, conditions that||
0093|152|P|increase your risk of seizures (such as brain/head injury, brain||
0093|153|P|tumors, cerebral atherosclerosis), blood vessel problems (such as||
0093|154|P|aneurysm or blockage of the aorta or other blood vessels,||
0093|155|P|hardening of the arteries), high blood pressure, certain genetic||
0093|156|P|conditions (Marfan syndrome, Ehlers-Danlos syndrome).||
0093|157|P|   Ciprofloxacin may cause a condition that affects the heart||
0093|158|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0093|159|P|serious (rarely fatal) fast/irregular heartbeat and other||
0093|160|P|symptoms (such as severe dizziness, fainting) that need medical||
0093|161|P|attention right away.||
0093|162|P|   The risk of QT prolongation may be increased if you have||
0093|163|P|certain medical conditions or are taking other drugs that may||
0093|164|P|cause QT prolongation. Before using ciprofloxacin, tell your||
0093|165|P|doctor or pharmacist of all the drugs you take and if you have||
0093|166|P|any of the following conditions: certain heart problems (heart||
0093|167|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0093|168|P|history of certain heart problems (QT prolongation in the EKG,||
0093|169|P|sudden cardiac death).||
0093|170|P|   Low levels of potassium or magnesium in the blood may also||
0093|171|P|increase your risk of QT prolongation. This risk may increase if||
0093|172|P|you use certain drugs (such as diuretics/"water pills") or if you||
0093|173|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0093|174|P|Talk to your doctor about using ciprofloxacin safely.||
0093|175|P|   This medication may rarely cause serious changes in blood||
0093|176|P|sugar, especially if you have diabetes. Check your blood sugar||
0093|177|P|regularly as directed and share the results with your doctor.||
0093|178|P|Watch for symptoms of high blood sugar such as increased||
0093|179|P|thirst/urination. Ciprofloxacin may increase the||
0093|180|P|blood-sugar-lowering effects of the medication glyburide. Also||
0093|181|P|watch for symptoms of low blood sugar such as sudden sweating,||
0093|182|P|shaking, fast heartbeat, hunger, blurred vision, dizziness, or||
0093|183|P|tingling hands/feet. It is a good habit to carry glucose tablets||
0093|184|P|or gel to treat low blood sugar. If you don't have these reliable||
0093|185|P|forms of glucose, rapidly raise your blood sugar by eating a||
0093|186|P|quick source of sugar such as table sugar, honey, or candy, or by||
0093|187|P|drinking fruit juice or non- diet soda. Tell your doctor right||
0093|188|P|away about the reaction and the use of this product. To help||
0093|189|P|prevent low blood sugar, eat meals on a regular schedule, and do||
0093|190|P|not skip meals. Your doctor may need to switch you to another||
0093|191|P|antibiotic or adjust your diabetes medications if any reaction||
0093|192|P|occurs.||
0093|193|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0093|194|P|can make you more dizzy. Do not drive, use machinery, or do||
0093|195|P|anything that needs alertness until you can do it safely. Limit||
0093|196|P|alcoholic beverages. Talk to your doctor if you are using||
0093|197|P|marijuana (cannabis).||
0093|198|P|   This medication may make you more sensitive to the sun. Limit||
0093|199|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0093|200|P|sunscreen and wear protective clothing when outdoors. Tell your||
0093|201|P|doctor right away if you get sunburned or have skin||
0093|202|P|blisters/redness.||
0093|203|P|   Ciprofloxacin may cause live bacterial vaccines (such as||
0093|204|P|typhoid vaccine) to not work well. Tell your health care||
0093|205|P|professional that you are using ciprofloxacin before having any||
0093|206|P|immunizations/vaccinations.||
0093|207|P|   Before having surgery, tell your doctor or dentist about all||
0093|208|P|the products you use (including prescription drugs,||
0093|209|P|nonprescription drugs, and herbal products).||
0093|210|P|   Children may be more sensitive to the side effects of this||
0093|211|P|drug, especially joint/tendon problems.||
0093|212|P|   Older adults may be at greater risk for tendon problems||
0093|213|P|(especially if they are also taking corticosteroids such as||
0093|214|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
0093|215|P|tear/break in the main blood vessel (aorta).||
0093|216|P|   During pregnancy, this medication should be used only when||
0093|217|P|clearly needed. Discuss the risks and benefits with your doctor.||
0093|218|P|   This medication passes into breast milk and may have||
0093|219|P|undesirable effects on a nursing infant. Consult your doctor||
0093|220|P|before breastfeeding.||
0093|221|B|||
0093|222|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
0093|223|I|   Drug interactions may change how your medications work or||
0093|224|I|increase your risk for serious side effects. This document does||
0093|225|I|not contain all possible drug interactions. Keep a list of all||
0093|226|I|the products you use (including prescription/nonprescription||
0093|227|I|drugs and herbal products) and share it with your doctor and||
0093|228|I|pharmacist. Do not start, stop, or change the dosage of any||
0093|229|I|medicines without your doctor's approval.||
0093|230|I|   Some products that may interact with this drug include: "blood||
0093|231|I|thinners" (such as acenocoumarol, warfarin), strontium.||
0093|232|I|   Many drugs besides ciprofloxacin may affect the heart rhythm||
0093|233|I|(QT prolongation), including amiodarone, dofetilide, quinidine,||
0093|234|I|procainamide, sotalol, among others.||
0093|235|I|   This medication can slow down the removal of other medications||
0093|236|I|from your body, which may affect how they work. Examples of||
0093|237|I|affected drugs include duloxetine, fezolinetant, pirfenidone,||
0093|238|I|tasimelteon, tizanidine, vorasidenib, among others.||
0093|239|B|||
0093|240|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0093|241|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0093|242|O|poison control center right away. US residents can call||
0093|243|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0093|244|B|||
0093|245|N|NOTES:  Do not share this medication with others.||
0093|246|N|   This medication has been prescribed for your current condition||
0093|247|N|only. Do not use it later for another infection unless your||
0093|248|N|doctor tells you to.||
0093|249|N|   Lab and/or medical tests (such as kidney function, blood||
0093|250|N|counts, cultures) should be done while you are taking this||
0093|251|N|medication. Keep all medical and lab appointments. Consult your||
0093|252|N|doctor for more details.||
0093|253|N|   Do not change brands of this medication without checking with||
0093|254|N|your doctor or pharmacist. Not all brands have the same effects.||
0093|255|B|||
0093|256|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0093|257|D|remember. If it is less than 6 hours before the next dose, skip||
0093|258|D|the missed dose. Take your next dose at the regular time. Do not||
0093|259|D|double the dose to catch up.||
0093|260|B|||
0093|261|R|STORAGE:  Store at room temperature away from light and moisture.||
0093|262|R|Do not store in the bathroom. Keep all medications away from||
0093|263|R|children and pets.||
0093|264|R|   Do not flush medications down the toilet or pour them into a||
0093|265|R|drain unless instructed to do so. Properly discard this product||
0093|266|R|when it is expired or no longer needed. Consult your pharmacist||
0093|267|R|or local waste disposal company.||
0093|268|B|||
0093|269|A|Information last revised September 2025.||
0093|270|A|Copyright(c) 2025 First Databank, Inc.||
0093|271|B|||
0094|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0094|002|Z|does NOT have all possible information about this product. This||
0094|003|Z|information does not assure that this product is safe, effective,||
0094|004|Z|or appropriate for you. This information is not individual||
0094|005|Z|medical advice and does not substitute for the advice of your||
0094|006|Z|health care professional. Always ask your health care||
0094|007|Z|professional for complete information about this product and your||
0094|008|Z|specific health needs.||
0094|009|B|||
0094|010|T|METHYLPHENIDATE - ORAL||
0094|011|F|(METH-il-FEN-i-date)||
0094|012|B|||
0094|013|C|COMMON BRAND NAME(S): Ritalin||
0094|014|B|||
0094|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
0094|016|W|serious (possibly fatal) heart and blood pressure problems.||
0094|017|W|   This medication can be habit-forming and should be used||
0094|018|W|cautiously by people who have mental/mood disorders or a||
0094|019|W|substance use disorder (such as overuse of or addiction to||
0094|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
0094|021|W|you have a personal or family history of a substance use||
0094|022|W|disorder. Do not increase your dose, use it more often, or use it||
0094|023|W|for a longer time or in a different way than prescribed. Doing so||
0094|024|W|may result in a decrease in the effect of this drug, drug||
0094|025|W|dependence, or abnormal thoughts/behavior.||
0094|026|W|   Your doctor may monitor you for a while after the medication||
0094|027|W|is stopped, especially if you have taken this drug for a long||
0094|028|W|time or in high doses. (See also How to Use section.)||
0094|029|B|||
0094|030|U|USES:  This medication is used to treat attention deficit||
0094|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
0094|032|U|of certain natural substances in the brain. Methylphenidate||
0094|033|U|belongs to a class of drugs known as stimulants. It can help||
0094|034|U|increase your ability to pay attention, stay focused on an||
0094|035|U|activity, and control behavior problems. It may also help you to||
0094|036|U|organize your tasks and improve listening skills.||
0094|037|U|   This medication is also used to treat a certain sleep disorder||
0094|038|U|(narcolepsy).||
0094|039|B|||
0094|040|H|HOW TO USE:  Read the Medication Guide provided by your||
0094|041|H|pharmacist before you start taking methylphenidate and each time||
0094|042|H|you get a refill. If you have any questions, ask your doctor or||
0094|043|H|pharmacist.||
0094|044|H|   Take this medication by mouth as directed by your doctor,||
0094|045|H|usually 2 or 3 times a day. This medication is best taken 30 to||
0094|046|H|45 minutes before a meal. However, if you have stomach upset, you||
0094|047|H|may take this medication with or after a meal or snack. Taking||
0094|048|H|this medication late in the day may cause trouble sleeping||
0094|049|H|(insomnia).||
0094|050|H|   Take this medication regularly to get the most benefit from||
0094|051|H|it. To help you remember, take it at the same times each day.||
0094|052|H|   The dosage is based on your medical condition and response to||
0094|053|H|treatment. Your doctor may direct you to gradually increase or||
0094|054|H|decrease your dose. Also, if you have used it for a long time, do||
0094|055|H|not suddenly stop using this drug without consulting your doctor.||
0094|056|H|   If you suddenly stop using this medication, you may have||
0094|057|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
0094|058|H|other mental/mood changes). To help prevent withdrawal, your||
0094|059|H|doctor may lower your dose slowly. Withdrawal is more likely if||
0094|060|H|you have used methylphenidate for a long time or in high doses.||
0094|061|H|Tell your doctor or pharmacist right away if you have withdrawal.||
0094|062|H|   When used for a long time, this medication may not work as||
0094|063|H|well. Talk with your doctor if this medication stops working||
0094|064|H|well.||
0094|065|H|   Though it helps many people, this medication may sometimes||
0094|066|H|cause addiction. This risk may be higher if you have a substance||
0094|067|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0094|068|H|Take this medication exactly as prescribed to lower the risk of||
0094|069|H|addiction. Ask your doctor or pharmacist for more details.||
0094|070|H|   Tell your doctor if your condition does not get better or if||
0094|071|H|it gets worse.||
0094|072|B|||
0094|073|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
0094|074|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
0094|075|S|If any of these effects last or get worse, tell your doctor or||
0094|076|S|pharmacist promptly.||
0094|077|S|   Remember that this medication has been prescribed because your||
0094|078|S|doctor has judged that the benefit to you is greater than the||
0094|079|S|risk of side effects. Many people using this medication do not||
0094|080|S|have serious side effects.||
0094|081|S|   This medication may raise your blood pressure. Check your||
0094|082|S|blood pressure regularly and tell your doctor if the results are||
0094|083|S|high.||
0094|084|S|   Tell your doctor right away if you have any serious side||
0094|085|S|effects, including: signs of blood flow problems in the fingers||
0094|086|S|or toes (such as coldness, numbness, pain, or skin color||
0094|087|S|changes), unusual wounds on the fingers or toes,||
0094|088|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
0094|089|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
0094|090|S|thoughts of suicide), uncontrolled muscle movements (such as||
0094|091|S|twitching, shaking), sudden outbursts of words/sounds that are||
0094|092|S|hard to control, vision changes (such as blurred vision).||
0094|093|S|   Get medical help right away if you have any very serious side||
0094|094|S|effects, including: fainting, seizure, symptoms of a heart attack||
0094|095|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
0094|096|S|sweating), symptoms of a stroke (such as weakness on one side of||
0094|097|S|the body, trouble speaking, sudden vision changes, confusion).||
0094|098|S|   Rarely, males (including young boys and teens) may have a||
0094|099|S|painful or prolonged erection lasting 4 or more hours while using||
0094|100|S|this medication. Caregivers/parents should also be watchful for||
0094|101|S|this serious side effect in boys. If a painful or prolonged||
0094|102|S|erection occurs, stop using this drug and get medical help right||
0094|103|S|away, or permanent problems could occur. Ask your doctor or||
0094|104|S|pharmacist for more details.||
0094|105|S|   A very serious allergic reaction to this drug is rare.||
0094|106|S|However, get medical help right away if you notice any symptoms||
0094|107|S|of a serious allergic reaction, including: rash, itching/swelling||
0094|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0094|109|S|breathing.||
0094|110|S|   This is not a complete list of possible side effects. If you||
0094|111|S|notice other effects not listed above, contact your doctor or||
0094|112|S|pharmacist.||
0094|113|S|   In the US -||
0094|114|S|   Call your doctor for medical advice about side effects. You||
0094|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0094|116|S|www.fda.gov/medwatch.||
0094|117|S|   In Canada - Call your doctor for medical advice about side||
0094|118|S|effects. You may report side effects to Health Canada at||
0094|119|S|1-866-234-2345.||
0094|120|B|||
0094|121|P|PRECAUTIONS:  See also Warning section.||
0094|122|P|   Before taking methylphenidate, tell your doctor or pharmacist||
0094|123|P|if you are allergic to it; or to dexmethylphenidate; or if you||
0094|124|P|have any other allergies. This product may contain inactive||
0094|125|P|ingredients, which can cause allergic reactions or other||
0094|126|P|problems. Talk to your pharmacist for more details.||
0094|127|P|   Before using this medication, tell your doctor or pharmacist||
0094|128|P|your medical history, especially of: high blood pressure, blood||
0094|129|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
0094|130|P|problems (such as irregular heartbeat, heart failure, previous||
0094|131|P|heart attack, problems with heart structure), family history of||
0094|132|P|heart problems (such as sudden cardiac death, irregular||
0094|133|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
0094|134|P|agitation), personal/family history of mental/mood disorders||
0094|135|P|(such as bipolar disorder, depression, psychosis, suicidal||
0094|136|P|thoughts), personal/family history of uncontrolled muscle||
0094|137|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
0094|138|P|(hyperthyroidism), seizure disorder.||
0094|139|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0094|140|P|can make you more dizzy. Do not drive, use machinery, or do||
0094|141|P|anything that needs alertness until you can do it safely. Limit||
0094|142|P|alcoholic beverages. Talk to your doctor if you are using||
0094|143|P|marijuana (cannabis).||
0094|144|P|   Before having surgery, tell your doctor or dentist about all||
0094|145|P|the products you use (including prescription drugs,||
0094|146|P|nonprescription drugs, and herbal products).||
0094|147|P|   If used for a long time, this drug may affect a child's growth||
0094|148|P|rate, weight, and final adult height. To reduce the risk, the||
0094|149|P|doctor may recommend briefly stopping the medication from time to||
0094|150|P|time. Check the child's weight and height regularly, and consult||
0094|151|P|your doctor or pharmacist for more details.||
0094|152|P|   Older adults may be more sensitive to the side effects of this||
0094|153|P|drug, especially trouble sleeping, weight loss, or chest pain.||
0094|154|P|   During pregnancy, methylphenidate should be used only when||
0094|155|P|clearly needed. Discuss the risks and benefits with your doctor.||
0094|156|P|   This medication passes into breast milk. Consult your doctor||
0094|157|P|before breastfeeding.||
0094|158|B|||
0094|159|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0094|160|I|medications work or increase your risk for serious side effects.||
0094|161|I|This document does not contain all possible drug interactions.||
0094|162|I|Keep a list of all the products you use (including||
0094|163|I|prescription/nonprescription drugs and herbal products) and share||
0094|164|I|it with your doctor and pharmacist. Do not start, stop, or change||
0094|165|I|the dosage of any medicines without your doctor's approval.||
0094|166|I|   Taking MAO inhibitors with this medication may cause a serious||
0094|167|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0094|168|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0094|169|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0094|170|I|selegiline, tranylcypromine) during treatment with this||
0094|171|I|medication. Most MAO inhibitors should also not be taken for two||
0094|172|I|weeks before treatment with this medication. Ask your doctor when||
0094|173|I|to start or stop taking this medication.||
0094|174|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
0094|175|I|use medications containing dexmethylphenidate while using||
0094|176|I|methylphenidate.||
0094|177|I|   This medication may interfere with certain medical/lab tests||
0094|178|I|(such as brain scan for Parkinson's disease), possibly causing||
0094|179|I|false test results. Make sure lab personnel and all your doctors||
0094|180|I|know you use this drug.||
0094|181|B|||
0094|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0094|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0094|184|O|poison control center right away. US residents can call||
0094|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0094|186|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
0094|187|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
0094|188|O|loss of consciousness.||
0094|189|B|||
0094|190|N|NOTES:  Do not share this medication with others. Sharing it is||
0094|191|N|against the law.||
0094|192|N|   Lab and/or medical tests (such as blood pressure, complete||
0094|193|N|blood count, height/weight monitoring in children) may be done||
0094|194|N|while you are taking this medication. Keep all medical and lab||
0094|195|N|appointments. Consult your doctor for more details.||
0094|196|N|   There are different brands and forms of this medication||
0094|197|N|available. Not all have the same effects. Do not change brands or||
0094|198|N|forms without consulting your doctor or pharmacist.||
0094|199|B|||
0094|200|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0094|201|D|remember. If it is near bedtime or near the time of the next||
0094|202|D|dose, skip the missed dose. Take your next dose at the regular||
0094|203|D|time. Do not double the dose to catch up.||
0094|204|B|||
0094|205|R|STORAGE:  Different brands of this medication have different||
0094|206|R|storage needs. Check the product package for instructions on how||
0094|207|R|to store your brand, or ask your pharmacist. Do not store in the||
0094|208|R|bathroom. Keep all medications away from children and pets.||
0094|209|R|   Do not flush medications down the toilet or pour them into a||
0094|210|R|drain unless instructed to do so. Properly discard this product||
0094|211|R|when it is expired or no longer needed. Consult your pharmacist||
0094|212|R|or local waste disposal company.||
0094|213|B|||
0094|214|A|Information last revised October 2024.||
0094|215|A|Copyright(c) 2025 First Databank, Inc.||
0094|216|B|||
0095|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0095|002|Z|does NOT have all possible information about this product. This||
0095|003|Z|information does not assure that this product is safe, effective,||
0095|004|Z|or appropriate for you. This information is not individual||
0095|005|Z|medical advice and does not substitute for the advice of your||
0095|006|Z|health care professional. Always ask your health care||
0095|007|Z|professional for complete information about this product and your||
0095|008|Z|specific health needs.||
0095|009|B|||
0095|010|T|FLUOXETINE - ORAL||
0095|011|F|(floo-OX-e-teen)||
0095|012|B|||
0095|013|C|COMMON BRAND NAME(S): Prozac, Sarafem||
0095|014|B|||
0095|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0095|016|W|of conditions, including depression and other mental/mood||
0095|017|W|disorders. These medications can help prevent suicidal||
0095|018|W|thoughts/attempts and provide other important benefits. However,||
0095|019|W|studies have shown that a small number of people (especially||
0095|020|W|people younger than 25) who take antidepressants for any||
0095|021|W|condition may experience worsening depression, other mental/mood||
0095|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0095|023|W|talk with the doctor about the risks and benefits of||
0095|024|W|antidepressant medication (especially for people younger than||
0095|025|W|25), even if treatment is not for a mental/mood condition.||
0095|026|W|   Tell the doctor right away if you notice worsening||
0095|027|W|depression/other psychiatric conditions, unusual behavior changes||
0095|028|W|(including possible suicidal thoughts/attempts), or other||
0095|029|W|mental/mood changes (including new/worsening anxiety, panic||
0095|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0095|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0095|032|W|especially watchful for these symptoms when a new antidepressant||
0095|033|W|is started or when the dose is changed.||
0095|034|B|||
0095|035|U|USES:  This medication is used to treat certain mental/mood||
0095|036|U|disorders (such as depression, panic attacks, obsessive||
0095|037|U|compulsive disorder). It is also used to treat a certain eating||
0095|038|U|disorder (bulimia) and a severe form of premenstrual syndrome||
0095|039|U|(premenstrual dysphoric disorder). Fluoxetine belongs to a class||
0095|040|U|of drugs known as selective serotonin reuptake inhibitors||
0095|041|U|(SSRIs). It works by helping to restore the balance of a certain||
0095|042|U|natural substance (serotonin) in the brain.||
0095|043|B|||
0095|044|V|OTHER USES:  This section contains uses of this drug that are not||
0095|045|V|listed in the approved professional labeling for the drug but||
0095|046|V|that may be prescribed by your health care professional. Use this||
0095|047|V|drug for a condition that is listed in this section only if it||
0095|048|V|has been so prescribed by your health care professional.||
0095|049|V|   This drug may also be used for other eating disorders||
0095|050|V|(anorexia nervosa, binge eating disorder-BED), post traumatic||
0095|051|V|stress disorder (PTSD), certain nervous system/sleep disorders||
0095|052|V|(cataplexy, narcolepsy), or hot flashes that occur with||
0095|053|V|menopause.||
0095|054|B|||
0095|055|H|HOW TO USE:  Read the Medication Guide provided by your||
0095|056|H|pharmacist before you start using fluoxetine and each time you||
0095|057|H|get a refill. If you have any questions, ask your doctor or||
0095|058|H|pharmacist.||
0095|059|H|   Take this medication by mouth with or without food as directed||
0095|060|H|by your doctor, usually once daily in the morning. If you are||
0095|061|H|taking this medication twice a day, your doctor may direct you to||
0095|062|H|take it in the morning and at noon.||
0095|063|H|   If you are taking fluoxetine for premenstrual problems, your||
0095|064|H|doctor may direct you to take it every day of the month or just||
0095|065|H|for the 2 weeks before your period through the first full day of||
0095|066|H|your period. To help you remember, mark your calendar with a||
0095|067|H|reminder.||
0095|068|H|   If you are using the liquid form of this medication, measure||
0095|069|H|the dose carefully using a special measuring device/spoon. Do not||
0095|070|H|use a household spoon because you may not get the correct dose.||
0095|071|H|   The dosage is based on your medical condition and response to||
0095|072|H|treatment. To reduce your risk of side effects, your doctor may||
0095|073|H|direct you to start this medication at a low dose and gradually||
0095|074|H|increase your dose. Follow your doctor's instructions carefully.||
0095|075|H|Take this medication regularly to get the most benefit from it.||
0095|076|H|To help you remember, take it at the same time each day.||
0095|077|H|   Keep taking this medication even if you feel well. Do not stop||
0095|078|H|taking this medication without first consulting your doctor. Some||
0095|079|H|conditions may become worse when the drug is abruptly stopped.||
0095|080|H|Your dose may need to be gradually decreased.||
0095|081|H|   You should see some improvement in 1 to 2 weeks. It may take 4||
0095|082|H|to 5 weeks before you feel the full benefit.||
0095|083|H|   Tell your doctor if your condition does not get better or if||
0095|084|H|it gets worse.||
0095|085|B|||
0095|086|S|SIDE EFFECTS:  See also Warning section.||
0095|087|S|   Nausea, drowsiness, dizziness, anxiety, trouble sleeping, loss||
0095|088|S|of appetite, tiredness, sweating, or yawning may occur. If any of||
0095|089|S|these effects last or get worse, tell your doctor promptly.||
0095|090|S|   Remember that this medication has been prescribed because your||
0095|091|S|doctor has judged that the benefit to you is greater than the||
0095|092|S|risk of side effects. Many people using this medication do not||
0095|093|S|have serious side effects.||
0095|094|S|   Tell your doctor right away if you have any serious side||
0095|095|S|effects, including: unusual or severe mental/mood changes (such||
0095|096|S|as agitation, unusual high energy/excitement, thoughts of||
0095|097|S|suicide), easy bleeding/bruising, muscle weakness/spasm,||
0095|098|S|shakiness (tremor), decreased interest in sex, changes in sexual||
0095|099|S|ability, unusual weight loss.||
0095|100|S|   Get medical help right away if you have any very serious side||
0095|101|S|effects, including: black stools, vomit that looks like coffee||
0095|102|S|grounds, seizures, signs of kidney problems (such as change in||
0095|103|S|the amount of urine), eye pain/swelling/redness, widened pupils,||
0095|104|S|vision changes (such as seeing rainbows around lights at night,||
0095|105|S|blurred vision).||
0095|106|S|   If you have diabetes, fluoxetine may affect your blood sugar||
0095|107|S|levels. Monitor your blood sugar regularly and share the results||
0095|108|S|with your doctor. Your doctor may need to adjust your medication,||
0095|109|S|diet, and exercise when you start or stop fluoxetine.||
0095|110|S|   This medication may increase serotonin and rarely cause a very||
0095|111|S|serious condition called serotonin syndrome/toxicity. The risk||
0095|112|S|increases if you are also taking other drugs that increase||
0095|113|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0095|114|S|take (see Drug Interactions section). Get medical help right away||
0095|115|S|if you develop some of the following symptoms: fast heartbeat,||
0095|116|S|hallucinations, loss of coordination, severe dizziness, severe||
0095|117|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0095|118|S|unusual agitation/restlessness.||
0095|119|S|   Rarely, males may have a painful or prolonged erection lasting||
0095|120|S|4 or more hours. If this occurs, stop using this drug and get||
0095|121|S|medical help right away, or permanent problems could occur.||
0095|122|S|   A very serious allergic reaction to this drug is rare.||
0095|123|S|However, get medical help right away if you notice any symptoms||
0095|124|S|of a serious allergic reaction, including: rash, itching/swelling||
0095|125|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0095|126|S|breathing.||
0095|127|S|   This is not a complete list of possible side effects. If you||
0095|128|S|notice other effects not listed above, contact your doctor or||
0095|129|S|pharmacist.||
0095|130|S|   In the US -||
0095|131|S|   Call your doctor for medical advice about side effects. You||
0095|132|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0095|133|S|www.fda.gov/medwatch.||
0095|134|S|   In Canada - Call your doctor for medical advice about side||
0095|135|S|effects. You may report side effects to Health Canada at||
0095|136|S|1-866-234-2345.||
0095|137|B|||
0095|138|P|PRECAUTIONS:  Before taking fluoxetine, tell your doctor or||
0095|139|P|pharmacist if you are allergic to it; or if you have any other||
0095|140|P|allergies. This product may contain inactive ingredients, which||
0095|141|P|can cause allergic reactions or other problems. Talk to your||
0095|142|P|pharmacist for more details.||
0095|143|P|   Before using this medication, tell your doctor or pharmacist||
0095|144|P|your medical history, especially of: personal or family history||
0095|145|P|of bipolar/manic-depressive disorder, personal or family history||
0095|146|P|of suicide attempts, liver problems, diabetes, low sodium in the||
0095|147|P|blood (such as may occur while taking "water pills" - diuretics),||
0095|148|P|severe dehydration, seizures, intestinal ulcers/bleeding (peptic||
0095|149|P|ulcer disease), personal or family history of glaucoma||
0095|150|P|(angle-closure type).||
0095|151|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0095|152|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0095|153|P|machinery, or do anything that needs alertness until you can do||
0095|154|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0095|155|P|are using marijuana (cannabis).||
0095|156|P|   The liquid form of this medication contains alcohol. Caution||
0095|157|P|is advised if you have diabetes, alcohol dependence, or liver||
0095|158|P|disease. Some medications (such as metronidazole, disulfiram) can||
0095|159|P|cause a serious reaction when combined with alcohol. Ask your||
0095|160|P|doctor or pharmacist about using this product safely.||
0095|161|P|   Before having surgery, tell your doctor or dentist about all||
0095|162|P|the products you use (including prescription drugs,||
0095|163|P|nonprescription drugs, and herbal products).||
0095|164|P|   Children may be more sensitive to the side effects of this||
0095|165|P|drug, especially weight loss. Monitor weight and height in||
0095|166|P|children who are taking this drug.||
0095|167|P|   Older adults may be more sensitive to the side effects of this||
0095|168|P|drug, especially bleeding and loss of coordination. Loss of||
0095|169|P|coordination can increase the risk of falling. Older adults may||
0095|170|P|also be more likely to develop low sodium in the blood,||
0095|171|P|especially if they are taking "water pills" (diuretics).||
0095|172|P|   During pregnancy, this medication should be used only when||
0095|173|P|clearly needed. It may harm an unborn baby. Also, babies born to||
0095|174|P|mothers who have used this drug during the last 3 months of||
0095|175|P|pregnancy may rarely develop withdrawal symptoms such as||
0095|176|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
0095|177|P|constant crying. If you notice any of these symptoms in your||
0095|178|P|newborn, tell the doctor promptly.||
0095|179|P|   Since untreated mental/mood problems (such as depression,||
0095|180|P|panic attacks, obsessive compulsive disorder) can be a serious||
0095|181|P|condition, do not stop taking this medication unless directed by||
0095|182|P|your doctor. If you are planning pregnancy, become pregnant, or||
0095|183|P|think you may be pregnant, immediately discuss the benefits and||
0095|184|P|risks of using this medication during pregnancy with your doctor.||
0095|185|P|   This medication passes into breast milk and may have||
0095|186|P|undesirable effects on a nursing infant. Consult your doctor||
0095|187|P|before breastfeeding.||
0095|188|B|||
0095|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0095|190|I|medications work or increase your risk for serious side effects.||
0095|191|I|This document does not contain all possible drug interactions.||
0095|192|I|Keep a list of all the products you use (including||
0095|193|I|prescription/nonprescription drugs and herbal products) and share||
0095|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
0095|195|I|the dosage of any medicines without your doctor's approval.||
0095|196|I|   Fluoxetine can stay in your body for many weeks after your||
0095|197|I|last dose and may interact with many other medications. Before||
0095|198|I|using any medication, tell your doctor or pharmacist if you have||
0095|199|I|taken fluoxetine in the previous 5 weeks.||
0095|200|I|   Some products that may interact with this drug are: other||
0095|201|I|drugs that can cause bleeding/bruising (including antiplatelet||
0095|202|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
0095|203|I|"blood thinners" such as dabigatran/warfarin).||
0095|204|I|   Taking MAO inhibitors with his medication may cause a serious||
0095|205|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0095|206|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0095|207|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0095|208|I|selegiline, tranylcypromine) during treatment with this||
0095|209|I|medication. Most MAO inhibitors should also not be taken for 2||
0095|210|I|weeks before and at least 5 weeks after treatment with this||
0095|211|I|medication. Ask your doctor when to start or stop taking this||
0095|212|I|medication.||
0095|213|I|   This medication can slow down the removal of other medications||
0095|214|I|from your body, which may affect how they work. Examples of||
0095|215|I|affected drugs include pimozide, thioridazine, vinblastine,||
0095|216|I|antiarrhythmics (such as propafenone, flecainide), tricyclic||
0095|217|I|antidepressants (such as desipramine, imipramine), among others.||
0095|218|I|   Aspirin can increase the risk of bleeding when used with this||
0095|219|I|medication. However, if your doctor has told you to take low-dose||
0095|220|I|aspirin to prevent heart attack or stroke (usually 81-162||
0095|221|I|milligrams a day), you should keep taking the aspirin unless your||
0095|222|I|doctor tells you not to.||
0095|223|I|   The risk of serotonin syndrome/toxicity increases if you are||
0095|224|I|also taking other drugs that increase serotonin. Examples include||
0095|225|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0095|226|I|antidepressants (including other SSRIs such as||
0095|227|I|citalopram/paroxetine, SNRIs such as duloxetine/venlafaxine),||
0095|228|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
0095|229|I|may be more likely when you start or increase the dose of these||
0095|230|I|drugs.||
0095|231|I|   Tell your doctor or pharmacist if you are taking other||
0095|232|I|products that cause drowsiness including alcohol, marijuana||
0095|233|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0095|234|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0095|235|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0095|236|I|codeine). Check the labels on all your medicines (such as allergy||
0095|237|I|or cough-and-cold products) because they may contain ingredients||
0095|238|I|that cause drowsiness. Ask your pharmacist about using those||
0095|239|I|products safely.||
0095|240|I|   This medication may interfere with certain medical/lab tests||
0095|241|I|(such as brain scan for Parkinson's disease), possibly causing||
0095|242|I|false test results. Make sure lab personnel and all your doctors||
0095|243|I|know you use this drug.||
0095|244|B|||
0095|245|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0095|246|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0095|247|O|poison control center right away. US residents can call||
0095|248|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0095|249|O|Symptoms of overdose may include: fast/irregular heartbeat,||
0095|250|O|severe dizziness, fainting.||
0095|251|B|||
0095|252|N|NOTES:  Do not share this medication with others.||
0095|253|N|   Keep all medical and lab appointments.||
0095|254|B|||
0095|255|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0095|256|D|remember. If it is near the time of the next dose, skip the||
0095|257|D|missed dose. Take your next dose at the regular time. Do not||
0095|258|D|double the dose to catch up.||
0095|259|B|||
0095|260|R|STORAGE:  Store at room temperature away from light and moisture.||
0095|261|R|Do not store in the bathroom. Keep all medications away from||
0095|262|R|children and pets.||
0095|263|R|   Do not flush medications down the toilet or pour them into a||
0095|264|R|drain unless instructed to do so. Properly discard this product||
0095|265|R|when it is expired or no longer needed. Consult your pharmacist||
0095|266|R|or local waste disposal company.||
0095|267|B|||
0095|268|A|Information last revised February 2025.||
0095|269|A|Copyright(c) 2025 First Databank, Inc.||
0095|270|B|||
0096|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0096|002|Z|does NOT have all possible information about this product. This||
0096|003|Z|information does not assure that this product is safe, effective,||
0096|004|Z|or appropriate for you. This information is not individual||
0096|005|Z|medical advice and does not substitute for the advice of your||
0096|006|Z|health care professional. Always ask your health care||
0096|007|Z|professional for complete information about this product and your||
0096|008|Z|specific health needs.||
0096|009|B|||
0096|010|T|GUAIFENESIN/DEXTROMETHORPHAN/DECONGESTANT - ORAL||
0096|011|B|||
0096|012|U|USES:  This combination medication is used to temporarily treat||
0096|013|U|cough, chest congestion, and stuffy nose symptoms caused by the||
0096|014|U|common cold, flu, allergies, hay fever, or other breathing||
0096|015|U|illnesses (such as sinusitis, bronchitis). Guaifenesin is an||
0096|016|U|expectorant that helps to thin and loosen mucus in the lungs,||
0096|017|U|making it easier to cough up the mucus. Dextromethorphan is a||
0096|018|U|cough suppressant that affects a certain part of the brain (cough||
0096|019|U|center), reducing the urge to cough. This product also contains a||
0096|020|U|decongestant, which helps relieve stuffy nose symptoms.||
0096|021|U|   This medication is usually not used for ongoing coughs from||
0096|022|U|smoking, asthma, other long-term breathing problems (such as||
0096|023|U|emphysema), or coughs with a lot of mucus, unless directed by||
0096|024|U|your doctor.||
0096|025|U|   Cough-and-cold products have not been shown to be safe or||
0096|026|U|effective in children younger than 6 years. Do not use this||
0096|027|U|product to treat cold symptoms in children younger than 6 years||
0096|028|U|unless specifically directed by the doctor. Some products (such||
0096|029|U|as long-acting tablets/capsules) are not recommended for use in||
0096|030|U|children younger than 12 years. Ask your doctor or pharmacist for||
0096|031|U|more details about using your product safely.||
0096|032|U|   These products do not cure or shorten the length of the common||
0096|033|U|cold and may cause serious side effects. To decrease the risk for||
0096|034|U|serious side effects, carefully follow all dosage directions. Do||
0096|035|U|not use this product to make a child sleepy. Do not give other||
0096|036|U|cough-and-cold medication that might contain the same or similar||
0096|037|U|ingredients (see also Drug Interactions section). Ask the doctor||
0096|038|U|or pharmacist about other ways to relieve cough and cold symptoms||
0096|039|U|(such as drinking enough fluids, using a humidifier or saline||
0096|040|U|nose drops/spray).||
0096|041|B|||
0096|042|H|HOW TO USE:  If you are taking the over-the-counter product, read||
0096|043|H|all directions on the product package before taking this||
0096|044|H|medication. If you have any questions, consult your pharmacist.||
0096|045|H|If your doctor has prescribed this medication, take it as||
0096|046|H|directed.||
0096|047|H|   Take the tablet, capsule, or liquid form by mouth with or||
0096|048|H|without food. Follow the directions for dosing on the label, or||
0096|049|H|take as directed by your doctor. Drink plenty of fluids when you||
0096|050|H|use this medication unless otherwise directed by your doctor. The||
0096|051|H|fluid will help loosen the mucus in your lungs. This medication||
0096|052|H|can be taken with food if stomach upset occurs.||
0096|053|H|   If you are using the liquid form, use a medication measuring||
0096|054|H|device to carefully measure the prescribed dose. Do not use a||
0096|055|H|household spoon. If your liquid form is a suspension, shake the||
0096|056|H|bottle well before each dose.||
0096|057|H|   If you are using sustained-release tablets or capsules,||
0096|058|H|swallow the medication whole. Do not crush or chew the tablets or||
0096|059|H|capsules. Doing so can destroy the long action of the drug and||
0096|060|H|may increase side effects.||
0096|061|H|   The dosage is based on your age, medical condition, and||
0096|062|H|response to treatment.||
0096|063|H|   Improper use of this medication (abuse) may result in serious||
0096|064|H|harm (such as brain damage, seizure, death). Do not increase your||
0096|065|H|dose or take this medication more often than recommended by your||
0096|066|H|doctor or the package instructions without your doctor's||
0096|067|H|approval.||
0096|068|H|   Tell your doctor if your condition lasts for more than 1 week,||
0096|069|H|if it gets worse, or if it occurs with a headache that doesn't go||
0096|070|H|away, a fever, or a rash. These may be symptoms of a serious||
0096|071|H|medical problem and should be checked by a doctor.||
0096|072|B|||
0096|073|S|SIDE EFFECTS:  Dizziness, headache, nausea, nervousness, or||
0096|074|S|trouble sleeping may occur. If any of these effects last or get||
0096|075|S|worse, contact your doctor or pharmacist promptly.||
0096|076|S|   If your doctor has prescribed this medication, remember that||
0096|077|S|your doctor has judged that the benefit to you is greater than||
0096|078|S|the risk of side effects. Many people using this medication do||
0096|079|S|not have serious side effects.||
0096|080|S|   This medication may raise your blood pressure. Check your||
0096|081|S|blood pressure regularly and tell your doctor if the results are||
0096|082|S|high.||
0096|083|S|   Tell your doctor right away if you have any serious side||
0096|084|S|effects, including: mental/mood changes (such as confusion,||
0096|085|S|hallucinations), shaking (tremors), weakness, fast/slow/irregular||
0096|086|S|heartbeat.||
0096|087|S|   A very serious allergic reaction to this drug is rare.||
0096|088|S|However, get medical help right away if you notice any symptoms||
0096|089|S|of a serious allergic reaction, including: rash, itching/swelling||
0096|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0096|091|S|breathing.||
0096|092|S|   This is not a complete list of possible side effects. If you||
0096|093|S|notice other effects not listed above, contact your doctor or||
0096|094|S|pharmacist.||
0096|095|S|   In the US -||
0096|096|S|   Call your doctor for medical advice about side effects. You||
0096|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0096|098|S|www.fda.gov/medwatch.||
0096|099|S|   In Canada - Call your doctor for medical advice about side||
0096|100|S|effects. You may report side effects to Health Canada at||
0096|101|S|1-866-234-2345.||
0096|102|B|||
0096|103|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0096|104|P|pharmacist if you are allergic to it; or if you have any other||
0096|105|P|allergies. This product may contain inactive ingredients, which||
0096|106|P|can cause allergic reactions or other problems. Talk to your||
0096|107|P|pharmacist for more details.||
0096|108|P|   Before using this medication, tell your doctor or pharmacist||
0096|109|P|your medical history, especially of: breathing problems (such as||
0096|110|P|asthma, emphysema), diabetes, a certain eye problem (glaucoma),||
0096|111|P|heart problems, high blood pressure, kidney problems, overactive||
0096|112|P|thyroid (hyperthyroidism), trouble urinating (for example, due to||
0096|113|P|enlarged prostate).||
0096|114|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0096|115|P|can make you more dizzy. Do not drive, use machinery, or do||
0096|116|P|anything that needs alertness until you can do it safely. Limit||
0096|117|P|alcoholic beverages. Talk to your doctor if you are using||
0096|118|P|marijuana (cannabis).||
0096|119|P|   Liquid preparations of this product may contain sugar,||
0096|120|P|aspartame, and/or alcohol. Caution is advised if you have||
0096|121|P|diabetes, alcohol dependence, liver disease, phenylketonuria||
0096|122|P|(PKU), or any other condition that requires you to limit/avoid||
0096|123|P|these substances in your diet. Ask your doctor or pharmacist||
0096|124|P|about using this product safely.||
0096|125|P|   Older adults may be more sensitive to the side effects of this||
0096|126|P|drug, especially dizziness, difficulty urinating, fast/irregular||
0096|127|P|heartbeat, trouble sleeping, confusion, or mental/mood changes.||
0096|128|P|   During pregnancy, this medication should be used only if||
0096|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
0096|130|P|   This medication may pass into breast milk. Consult your doctor||
0096|131|P|before breastfeeding.||
0096|132|B|||
0096|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0096|134|I|medications work or increase your risk for serious side effects.||
0096|135|I|This document does not contain all possible drug interactions.||
0096|136|I|Keep a list of all the products you use (including||
0096|137|I|prescription/nonprescription drugs and herbal products) and share||
0096|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
0096|139|I|the dosage of any medicines without your doctor's approval.||
0096|140|I|   Taking certain MAO inhibitors with this medication may cause a||
0096|141|I|serious (possibly fatal) drug interaction. Avoid taking||
0096|142|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
0096|143|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
0096|144|I|tranylcypromine during treatment with this medication. Most MAO||
0096|145|I|inhibitors should also not be taken for two weeks before||
0096|146|I|treatment with this medication. Ask your doctor when to start or||
0096|147|I|stop taking this medication.||
0096|148|I|   A product that may interact with this drug is: rolapitant.||
0096|149|I|   The ingredients in this product are available in many||
0096|150|I|prescription and nonprescription products. Check the labels on||
0096|151|I|all your medications carefully to make sure you are not taking||
0096|152|I|more than one product with the same ingredient(s). Consult your||
0096|153|I|pharmacist if you are unsure of the ingredients in any of your||
0096|154|I|medications.||
0096|155|I|   This medication may interfere with certain medical/lab tests||
0096|156|I|(including urine 5-HIAA/VMA levels, brain scan for Parkinson's||
0096|157|I|disease), possibly causing false test results. Make sure lab||
0096|158|I|personnel and all your doctors know you use this drug.||
0096|159|B|||
0096|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0096|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0096|162|O|poison control center right away. US residents can call||
0096|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0096|164|O|Symptoms of overdose may include: agitation, confusion,||
0096|165|O|hallucinations, seizures.||
0096|166|B|||
0096|167|N|NOTES:  If your doctor has prescribed this medication, do not||
0096|168|N|share it with others.||
0096|169|N|   Keep all medical and lab appointments.||
0096|170|B|||
0096|171|D|MISSED DOSE:  If you are prescribed this medication on a regular||
0096|172|D|schedule and miss a dose, take it as soon as you remember. If it||
0096|173|D|is near the time of the next dose, skip the missed dose. Take||
0096|174|D|your next dose at the regular time. Do not double the dose to||
0096|175|D|catch up.||
0096|176|B|||
0096|177|R|STORAGE:  Store at room temperature away from light and moisture.||
0096|178|R|Do not store in the bathroom. Do not freeze liquid forms of this||
0096|179|R|medication. Keep all medications away from children and pets.||
0096|180|R|   Do not flush medications down the toilet or pour them into a||
0096|181|R|drain unless instructed to do so. Properly discard this product||
0096|182|R|when it is expired or no longer needed. Consult your pharmacist||
0096|183|R|or local waste disposal company.||
0096|184|B|||
0096|185|A|Information last revised July 2025.||
0096|186|A|Copyright(c) 2025 First Databank, Inc.||
0096|187|B|||
0098|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0098|002|Z|does NOT have all possible information about this product. This||
0098|003|Z|information does not assure that this product is safe, effective,||
0098|004|Z|or appropriate for you. This information is not individual||
0098|005|Z|medical advice and does not substitute for the advice of your||
0098|006|Z|health care professional. Always ask your health care||
0098|007|Z|professional for complete information about this product and your||
0098|008|Z|specific health needs.||
0098|009|B|||
0098|010|T|RIMANTADINE - ORAL||
0098|011|F|(ri-MAN-ta-deen)||
0098|012|B|||
0098|013|C|COMMON BRAND NAME(S): Flumadine||
0098|014|B|||
0098|015|U|USES:  Rimantadine is used to prevent or treat a certain type of||
0098|016|U|flu virus (influenza A). If you have been infected with the flu,||
0098|017|U|this medication may help make your symptoms less severe and||
0098|018|U|shorten the time it will take you to get better. Taking||
0098|019|U|rimantadine if you have been or will be exposed to the flu may||
0098|020|U|help to prevent you from getting the flu. This medication is an||
0098|021|U|antiviral that is believed to work by stopping the growth of the||
0098|022|U|flu virus. This medication is not a vaccine. To increase the||
0098|023|U|chance that you will not get the flu, it is important to get a||
0098|024|U|flu shot once a year at the beginning of every flu season, if||
0098|025|U|possible.||
0098|026|U|   The Centers for Disease Control (CDC) recommends that||
0098|027|U|rimantadine should not be used for the treatment or prevention of||
0098|028|U|influenza A because the current influenza A virus in the United||
0098|029|U|States is resistant to this medication. For more details, talk to||
0098|030|U|your doctor or pharmacist.||
0098|031|B|||
0098|032|H|HOW TO USE:  Take this medication by mouth with or without food||
0098|033|H|as directed by your doctor. When this medication is taken to||
0098|034|H|prevent flu, children younger than 10 should usually take it once||
0098|035|H|a day, and children older than 10 and adults should take it twice||
0098|036|H|a day. When used to treat flu in adults, the medication is taken||
0098|037|H|twice a day. Do not increase your dose or take rimantadine more||
0098|038|H|often than prescribed.||
0098|039|H|   The dosage is based on your medical condition and response to||
0098|040|H|treatment. Children's dosage is also based on weight.||
0098|041|H|   Begin taking rimantadine as soon as possible after being||
0098|042|H|exposed to the flu or developing flu symptoms. Continue to take||
0098|043|H|this medication for the full time prescribed, even if symptoms||
0098|044|H|disappear after a few days. Stopping the medication too early may||
0098|045|H|result in a severe flu infection.||
0098|046|H|   If you are taking the syrup, measure the dose carefully with a||
0098|047|H|medication spoon/cup.||
0098|048|H|   Tell your doctor if your condition lasts or gets worse.||
0098|049|B|||
0098|050|S|SIDE EFFECTS:  Trouble sleeping, nausea, vomiting, loss of||
0098|051|S|appetite, dry mouth, weakness, dizziness, drowsiness, or||
0098|052|S|nervousness may occur. If any of these effects last or get worse,||
0098|053|S|notify your doctor or pharmacist promptly.||
0098|054|S|   Remember that this medication has been prescribed because your||
0098|055|S|doctor has judged that the benefit to you is greater than the||
0098|056|S|risk of side effects. Many people using this medication do not||
0098|057|S|have serious side effects.||
0098|058|S|   Tell your doctor right away if you have any serious side||
0098|059|S|effects, including: mental/mood changes (such as depression),||
0098|060|S|seizures.||
0098|061|S|   A very serious allergic reaction to this drug is rare.||
0098|062|S|However, get medical help right away if you notice any symptoms||
0098|063|S|of a serious allergic reaction, including: rash, itching/swelling||
0098|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0098|065|S|breathing.||
0098|066|S|   This is not a complete list of possible side effects. If you||
0098|067|S|notice other effects not listed above, contact your doctor or||
0098|068|S|pharmacist.||
0098|069|S|   In the US -||
0098|070|S|   Call your doctor for medical advice about side effects. You||
0098|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0098|072|S|www.fda.gov/medwatch.||
0098|073|S|   In Canada - Call your doctor for medical advice about side||
0098|074|S|effects. You may report side effects to Health Canada at||
0098|075|S|1-866-234-2345.||
0098|076|B|||
0098|077|P|PRECAUTIONS:  Before taking rimantadine, tell your doctor or||
0098|078|P|pharmacist if you are allergic to it; or to amantadine; or if you||
0098|079|P|have any other allergies. This product may contain inactive||
0098|080|P|ingredients, which can cause allergic reactions or other||
0098|081|P|problems. Talk to your pharmacist for more details.||
0098|082|P|   Before using this medication, tell your doctor or pharmacist||
0098|083|P|your medical history, especially of: liver disease, kidney||
0098|084|P|disease, seizures.||
0098|085|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0098|086|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0098|087|P|machinery, or do anything that needs alertness until you can do||
0098|088|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0098|089|P|are using marijuana (cannabis).||
0098|090|P|   Older adults may be at a greater risk for dizziness, headache,||
0098|091|P|or weakness while using this drug.||
0098|092|P|   During pregnancy, this medication should be used only when||
0098|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
0098|094|P|   It is unknown if this medication passes into breast milk.||
0098|095|P|However, similar drugs pass into breast milk and may have||
0098|096|P|undesirable effects on a nursing infant. Consult your doctor||
0098|097|P|before breastfeeding.||
0098|098|B|||
0098|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0098|100|I|medications work or increase your risk for serious side effects.||
0098|101|I|This document does not contain all possible drug interactions.||
0098|102|I|Keep a list of all the products you use (including||
0098|103|I|prescription/nonprescription drugs and herbal products) and share||
0098|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
0098|105|I|the dosage of any medicines without your doctor's approval.||
0098|106|I|   A product that may interact with this drug is: flu vaccine||
0098|107|I|inhaled through the nose.||
0098|108|B|||
0098|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0098|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0098|111|O|poison control center right away. US residents can call||
0098|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0098|113|O|Symptoms of overdose may include mental/mood changes (such as||
0098|114|O|agitation, hallucinations), irregular heartbeat, trouble||
0098|115|O|breathing, change in amount of urine, unconscious, fever, or||
0098|116|O|seizures.||
0098|117|B|||
0098|118|N|NOTES:  Do not share this product with others.||
0098|119|N|   This medication works best at reducing the length and severity||
0098|120|N|of the flu when taken within 24 to 48 hours of the first||
0098|121|N|appearance of flu symptoms.||
0098|122|B|||
0098|123|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0098|124|D|remember. If it is near the time of the next dose, skip the||
0098|125|D|missed dose. Take your next dose at the regular time. Do not||
0098|126|D|double the dose to catch up.||
0098|127|B|||
0098|128|R|STORAGE:  Store at room temperature away from light and moisture.||
0098|129|R|Do not store in the bathroom. Keep all medications away from||
0098|130|R|children and pets.||
0098|131|R|   Do not flush medications down the toilet or pour them into a||
0098|132|R|drain unless instructed to do so. Properly discard this product||
0098|133|R|when it is expired or no longer needed. Consult your pharmacist||
0098|134|R|or local waste disposal company.||
0098|135|B|||
0098|136|A|Information last revised October 2024.||
0098|137|A|Copyright(c) 2025 First Databank, Inc.||
0098|138|B|||
0099|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0099|002|Z|does NOT have all possible information about this product. This||
0099|003|Z|information does not assure that this product is safe, effective,||
0099|004|Z|or appropriate for you. This information is not individual||
0099|005|Z|medical advice and does not substitute for the advice of your||
0099|006|Z|health care professional. Always ask your health care||
0099|007|Z|professional for complete information about this product and your||
0099|008|Z|specific health needs.||
0099|009|B|||
0099|010|T|ATROPINE SULFATE - OPHTHALMIC||
0099|011|F|(AT-roe-peen SUL-fate)||
0099|012|B|||
0099|013|C|COMMON BRAND NAME(S): Isopto Atropine||
0099|014|B|||
0099|015|U|USES:  This medication is used before eye examinations (such as||
0099|016|U|refraction) and to treat certain eye conditions (such as||
0099|017|U|uveitis). It belongs to a class of drugs known as||
0099|018|U|anticholinergics. Atropine works by widening (dilating) the pupil||
0099|019|U|of the eye.||
0099|020|B|||
0099|021|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0099|022|H|directed by your doctor, usually 2 to 4 times daily.||
0099|023|H|   To apply eye drops, wash your hands first. To avoid||
0099|024|H|contamination, do not touch the dropper tip or let it touch your||
0099|025|H|eye or any other surface.||
0099|026|H|   If you are wearing contact lenses, remove them before using||
0099|027|H|eye drops. Wait at least 15 minutes before replacing your contact||
0099|028|H|lenses.||
0099|029|H|   Tilt your head back, look upward, and pull down the lower||
0099|030|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0099|031|H|and place one drop into the pouch. Look downward and gently close||
0099|032|H|your eyes for 1-2 minutes. Place one finger at the corner of your||
0099|033|H|eye (near the nose) and apply gentle pressure for 2 to 3 minutes.||
0099|034|H|This will prevent the medication from draining out. Try not to||
0099|035|H|blink and do not rub your eye. Repeat these steps for your other||
0099|036|H|eye if so directed or if your dose is for more than 1 drop.||
0099|037|H|   Do not rinse the dropper. Replace the dropper cap after each||
0099|038|H|use. Do not use the solution if it turns brown or cloudy or if it||
0099|039|H|contains particles.||
0099|040|H|   If you are using another kind of eye medication (such as drops||
0099|041|H|or ointments), wait at least 5-10 minutes before applying other||
0099|042|H|medications. Use eye drops before eye ointments to allow the||
0099|043|H|drops to enter the eye.||
0099|044|H|   Wait several minutes for your vision to clear before driving||
0099|045|H|or operating machinery.||
0099|046|H|   If you are using this medication on a regular schedule, you||
0099|047|H|can get the most benefit from it by not missing any doses. To||
0099|048|H|help you remember, use it at the same times each day. Keep using||
0099|049|H|it for the full time prescribed.||
0099|050|H|   Tell your doctor if your condition does not get better or if||
0099|051|H|it gets worse.||
0099|052|B|||
0099|053|S|SIDE EFFECTS:  Burning/stinging/redness of the eye, eye||
0099|054|S|irritation, or temporary blurred vision may occur. If any of||
0099|055|S|these effects last or get worse, tell your doctor or pharmacist||
0099|056|S|promptly.||
0099|057|S|   Remember that this medication has been prescribed because your||
0099|058|S|doctor has judged that the benefit to you is greater than the||
0099|059|S|risk of side effects. Many people using this medication do not||
0099|060|S|have serious side effects.||
0099|061|S|   Tell your doctor right away if you have any serious side||
0099|062|S|effects, including: dizziness, fainting, new or increased eye||
0099|063|S|pressure/pain/swelling/discharge, slow/shallow breathing,||
0099|064|S|mental/mood changes (such as confusion, agitation),||
0099|065|S|fast/irregular heartbeat.||
0099|066|S|   A very serious allergic reaction to this product is rare.||
0099|067|S|However, get medical help right away if you notice any symptoms||
0099|068|S|of a serious allergic reaction, including: rash, itching/swelling||
0099|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0099|070|S|breathing.||
0099|071|S|   This is not a complete list of possible side effects. If you||
0099|072|S|notice other effects not listed above, contact your doctor or||
0099|073|S|pharmacist.||
0099|074|S|   In the US -||
0099|075|S|   Call your doctor for medical advice about side effects. You||
0099|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0099|077|S|www.fda.gov/medwatch.||
0099|078|S|   In Canada - Call your doctor for medical advice about side||
0099|079|S|effects. You may report side effects to Health Canada at||
0099|080|S|1-866-234-2345.||
0099|081|B|||
0099|082|P|PRECAUTIONS:  Before using atropine, tell your doctor or||
0099|083|P|pharmacist if you are allergic to it; or to belladonna alkaloids||
0099|084|P|(such as hyoscyamine, scopolamine); or if you have any other||
0099|085|P|allergies. This product may contain inactive ingredients, which||
0099|086|P|can cause allergic reactions or other problems. Talk to your||
0099|087|P|pharmacist for more details.||
0099|088|P|   Before using this medication, tell your doctor or pharmacist||
0099|089|P|your medical history, especially of: personal or family history||
0099|090|P|of glaucoma (angle-closure type), Down's syndrome, brain damage||
0099|091|P|or spastic paralysis (in children).||
0099|092|P|   After you apply this drug, your vision may become temporarily||
0099|093|P|blurred. Do not drive, use machinery, or do anything that needs||
0099|094|P|clear vision until you can do it safely.||
0099|095|P|   This medication may make your eyes more sensitive to light.||
0099|096|P|Protect your eyes in bright light. Use dark sunglasses when||
0099|097|P|outdoors.||
0099|098|P|   Infants or small children may be more sensitive to the side||
0099|099|P|effects of this drug. Do not allow this medication to get into||
0099|100|P|the child's mouth. Remember to wash your hands after each use.||
0099|101|P|   During pregnancy, this medication should be used only when||
0099|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0099|103|P|   It is unknown if this drug passes into breast milk. Consult||
0099|104|P|your doctor before breastfeeding.||
0099|105|B|||
0099|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0099|107|I|medications work or increase your risk for serious side effects.||
0099|108|I|This document does not contain all possible drug interactions.||
0099|109|I|Keep a list of all the products you use (including||
0099|110|I|prescription/nonprescription drugs and herbal products) and share||
0099|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0099|112|I|the dosage of any medicines without your doctor's approval.||
0099|113|B|||
0099|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0099|115|O|has overdosed and has serious symptoms such as passing out or||
0099|116|O|trouble breathing, call 911. Otherwise, call a poison control||
0099|117|O|center right away. US residents can call 1-800-222-1222. Canada||
0099|118|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0099|119|O|include: flushed/dry skin, fast/irregular heartbeat, fever,||
0099|120|O|mental/mood changes (such as hallucinations), loss of||
0099|121|O|coordination.||
0099|122|B|||
0099|123|N|NOTES:  Do not share this medication with others.||
0099|124|B|||
0099|125|D|MISSED DOSE:  If you are using this drug on a regular schedule||
0099|126|D|and miss a dose, use it as soon as you remember. If it is near||
0099|127|D|the time of the next dose, skip the missed dose. Use your next||
0099|128|D|dose at the regular time. Do not double the dose to catch up.||
0099|129|B|||
0099|130|R|STORAGE:  Different brands of this medication have different||
0099|131|R|storage needs. Check the product package for instructions on how||
0099|132|R|to store your brand, or ask your pharmacist. Keep all medications||
0099|133|R|away from children and pets.||
0099|134|R|   If you are using the single-use containers, discard any unused||
0099|135|R|medication immediately after use.||
0099|136|R|   Do not flush medications down the toilet or pour them into a||
0099|137|R|drain unless instructed to do so. Properly discard this product||
0099|138|R|when it is expired or no longer needed. Consult your pharmacist||
0099|139|R|or local waste disposal company.||
0099|140|B|||
0099|141|A|Information last revised October 2024.||
0099|142|A|Copyright(c) 2025 First Databank, Inc.||
0099|143|B|||
0100|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0100|002|Z|does NOT have all possible information about this product. This||
0100|003|Z|information does not assure that this product is safe, effective,||
0100|004|Z|or appropriate for you. This information is not individual||
0100|005|Z|medical advice and does not substitute for the advice of your||
0100|006|Z|health care professional. Always ask your health care||
0100|007|Z|professional for complete information about this product and your||
0100|008|Z|specific health needs.||
0100|009|B|||
0100|010|T|BETHANECHOL - ORAL||
0100|011|F|(be-THAN-e-kol)||
0100|012|B|||
0100|013|C|COMMON BRAND NAME(S): Urecholine||
0100|014|B|||
0100|015|U|USES:  This medication is used to treat certain bladder problems||
0100|016|U|such as the inability to urinate or empty the bladder completely||
0100|017|U|due to certain causes (such as surgery, bladder muscle problems).||
0100|018|U|It works by helping the bladder muscle to squeeze better, thereby||
0100|019|U|improving your ability to urinate.||
0100|020|B|||
0100|021|V|OTHER USES:  This section contains uses of this drug that are not||
0100|022|V|listed in the approved professional labeling for the drug but||
0100|023|V|that may be prescribed by your health care professional. Use this||
0100|024|V|drug for a condition that is listed in this section only if it||
0100|025|V|has been so prescribed by your health care professional.||
0100|026|V|   This drug may also be used for heartburn. It works by helping||
0100|027|V|the stomach muscles move food down out of the stomach faster and||
0100|028|V|by increasing the strength of the muscle between the esophagus||
0100|029|V|and stomach (lower esophageal sphincter). This helps keep||
0100|030|V|food/acid in the stomach from rising back into the esophagus.||
0100|031|B|||
0100|032|H|HOW TO USE:  Take this medication by mouth on an empty stomach (1||
0100|033|H|hour before or 2 hours after meals) as directed by your doctor,||
0100|034|H|usually 3 to 4 times daily. Taking this medication on an empty||
0100|035|H|stomach will help reduce nausea/vomiting.||
0100|036|H|   Dosage is based on your medical condition and response to||
0100|037|H|treatment.||
0100|038|H|   Use this medication regularly to get the most benefit from it.||
0100|039|H|To help you remember, take it at the same times each day.||
0100|040|H|   Tell your doctor if your condition lasts or gets worse.||
0100|041|B|||
0100|042|S|SIDE EFFECTS:  Dizziness, lightheadedness, nausea, vomiting,||
0100|043|S|abdominal cramps/pain, diarrhea, increased saliva/urination,||
0100|044|S|sweating, flushing, watery eyes, or headache may occur. If any of||
0100|045|S|these effects last or get worse, tell your doctor or pharmacist||
0100|046|S|promptly.||
0100|047|S|   To reduce dizziness and lightheadedness, get up slowly when||
0100|048|S|rising from a sitting or lying position.||
0100|049|S|   Remember that this medication has been prescribed because your||
0100|050|S|doctor has judged that the benefit to you is greater than the||
0100|051|S|risk of side effects. Many people using this medication do not||
0100|052|S|have serious side effects.||
0100|053|S|   Tell your doctor right away if you have any serious side||
0100|054|S|effects, including: fainting, fast heartbeat, severe abdominal||
0100|055|S|pain.||
0100|056|S|   A very serious allergic reaction to this drug is rare.||
0100|057|S|However, get medical help right away if you notice any symptoms||
0100|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0100|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0100|060|S|breathing.||
0100|061|S|   This is not a complete list of possible side effects. If you||
0100|062|S|notice other effects not listed above, contact your doctor or||
0100|063|S|pharmacist.||
0100|064|S|   In the US -||
0100|065|S|   Call your doctor for medical advice about side effects. You||
0100|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0100|067|S|www.fda.gov/medwatch.||
0100|068|S|   In Canada - Call your doctor for medical advice about side||
0100|069|S|effects. You may report side effects to Health Canada at||
0100|070|S|1-866-234-2345.||
0100|071|B|||
0100|072|P|PRECAUTIONS:  Before taking bethanechol, tell your doctor or||
0100|073|P|pharmacist if you are allergic to it; or if you have any other||
0100|074|P|allergies. This product may contain inactive ingredients, which||
0100|075|P|can cause allergic reactions or other problems. Talk to your||
0100|076|P|pharmacist for more details.||
0100|077|P|   Before using this medication, tell your doctor or pharmacist||
0100|078|P|your medical history, especially of: recent||
0100|079|P|stomach/intestinal/bladder surgery, stomach/intestinal problems||
0100|080|P|(such as ulcers, blockage, spasms), peritonitis, blockage of the||
0100|081|P|bladder, a certain nerve problem (vagotonia), overactive thyroid||
0100|082|P|(hyperthyroidism), lung disease (such as asthma, chronic||
0100|083|P|obstructive pulmonary disease-COPD), heart problems (such as||
0100|084|P|coronary artery disease, slow heartbeat), seizures, Parkinson's||
0100|085|P|disease, blood pressure problems.||
0100|086|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0100|087|P|can make you more dizzy. Do not drive, use machinery, or do||
0100|088|P|anything that needs alertness until you can do it safely. Limit||
0100|089|P|alcoholic beverages. Talk to your doctor if you are using||
0100|090|P|marijuana (cannabis).||
0100|091|P|   During pregnancy, this medication should be used only when||
0100|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
0100|093|P|   It is unknown if this drug passes into breast milk. Consult||
0100|094|P|your doctor before breastfeeding.||
0100|095|B|||
0100|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0100|097|I|medications work or increase your risk for serious side effects.||
0100|098|I|This document does not contain all possible drug interactions.||
0100|099|I|Keep a list of all the products you use (including||
0100|100|I|prescription/nonprescription drugs and herbal products) and share||
0100|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0100|102|I|the dosage of any medicines without your doctor's approval.||
0100|103|I|   This medication may interfere with certain lab tests (such as||
0100|104|I|amylase/lipase levels), possibly causing false test results. Make||
0100|105|I|sure lab personnel and all your doctors know you use this drug.||
0100|106|B|||
0100|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0100|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0100|109|O|poison control center right away. US residents can call||
0100|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0100|111|O|Symptoms of overdose may include: stomach/abdominal pain,||
0100|112|O|flushing, increased saliva, sweating, nausea, vomiting.||
0100|113|B|||
0100|114|N|NOTES:  Do not share this medication with others.||
0100|115|B|||
0100|116|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0100|117|D|remember. If it is near the time of the next dose, skip the||
0100|118|D|missed dose. Take your next dose at the regular time. Do not||
0100|119|D|double the dose to catch up.||
0100|120|B|||
0100|121|R|STORAGE:  Store at room temperature away from light and moisture.||
0100|122|R|Do not store in the bathroom. Keep all medications away from||
0100|123|R|children and pets.||
0100|124|R|   Do not flush medications down the toilet or pour them into a||
0100|125|R|drain unless instructed to do so. Properly discard this product||
0100|126|R|when it is expired or no longer needed. Consult your pharmacist||
0100|127|R|or local waste disposal company.||
0100|128|B|||
0100|129|A|Information last revised May 2024.||
0100|130|A|Copyright(c) 2025 First Databank, Inc.||
0100|131|B|||
0104|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0104|002|Z|does NOT have all possible information about this product. This||
0104|003|Z|information does not assure that this product is safe, effective,||
0104|004|Z|or appropriate for you. This information is not individual||
0104|005|Z|medical advice and does not substitute for the advice of your||
0104|006|Z|health care professional. Always ask your health care||
0104|007|Z|professional for complete information about this product and your||
0104|008|Z|specific health needs.||
0104|009|B|||
0104|010|T|ACETAZOLAMIDE - ORAL||
0104|011|F|(a-SEET-a-ZOE-la-mide)||
0104|012|B|||
0104|013|C|COMMON BRAND NAME(S): Diamox||
0104|014|B|||
0104|015|U|USES:  Acetazolamide is used to prevent and reduce the symptoms||
0104|016|U|of altitude sickness. This medication can decrease headache,||
0104|017|U|tiredness, nausea, dizziness, and shortness of breath that can||
0104|018|U|occur when you climb quickly to high altitudes (generally above||
0104|019|U|10,000 feet/3,048 meters). It is particularly useful in||
0104|020|U|situations when you cannot make a slow ascent. The best ways to||
0104|021|U|prevent altitude sickness are climbing slowly, stopping for 24||
0104|022|U|hours during the climb to allow the body to adjust to the new||
0104|023|U|height, and taking it easy the first 1 to 2 days.||
0104|024|U|   This medication is also used with other medications to treat||
0104|025|U|high pressure inside the eye due to certain types of glaucoma.||
0104|026|U|Acetazolamide belongs to a class of drugs known as carbonic||
0104|027|U|anhydrase inhibitors. It works by decreasing the production of||
0104|028|U|fluid inside the eye. It is also used to decrease a buildup of||
0104|029|U|body fluids (edema) caused by heart failure or certain||
0104|030|U|medications. Acetazolamide can work less well over time, so it is||
0104|031|U|usually used only for a short period.||
0104|032|U|   It has also been used with other medications to treat certain||
0104|033|U|types of seizures (petit mal and unlocalized seizures).||
0104|034|B|||
0104|035|V|OTHER USES:  This section contains uses of this drug that are not||
0104|036|V|listed in the approved professional labeling for the drug but||
0104|037|V|that may be prescribed by your health care professional. Use this||
0104|038|V|drug for a condition that is listed in this section only if it||
0104|039|V|has been so prescribed by your health care professional.||
0104|040|V|   This drug may also be used for a certain condition causing a||
0104|041|V|serious increase in pressure inside the skull (intracranial||
0104|042|V|hypertension).||
0104|043|B|||
0104|044|H|HOW TO USE:  If you are taking the tablets, take this medication||
0104|045|H|by mouth as directed by your doctor, usually 1 to 4 times daily.||
0104|046|H|If you are taking the long-acting capsules, take this medication||
0104|047|H|by mouth as directed by your doctor, usually 1 or 2 times daily.||
0104|048|H|Swallow the long-acting capsules whole. Do not open, break, or||
0104|049|H|chew the capsules. Doing so can destroy the long action of the||
0104|050|H|drug and may increase side effects.||
0104|051|H|   Acetazolamide may be taken with or without food. Drink plenty||
0104|052|H|of fluids unless otherwise directed by your doctor. The dosage is||
0104|053|H|based on your medical condition and response to treatment.||
0104|054|H|   Do not change brands or dosage forms of this medication||
0104|055|H|without talking to your doctor or pharmacist. Not all forms of||
0104|056|H|this medication work the same way.||
0104|057|H|   To prevent altitude sickness, start taking acetazolamide 1 to||
0104|058|H|2 days before you start to climb. Keep taking it while you are||
0104|059|H|climbing and for at least 48 hours after you have reached your||
0104|060|H|final altitude. You may need to keep taking this medication while||
0104|061|H|staying at the high altitude to control your symptoms. If you||
0104|062|H|develop severe altitude sickness, it is important that you climb||
0104|063|H|down as quickly as possible. Acetazolamide will not protect you||
0104|064|H|from the serious effects of severe altitude sickness. (See also||
0104|065|H|Precautions.)||
0104|066|H|   If you are taking this drug for another condition (such as||
0104|067|H|glaucoma, seizures), use this medication regularly as directed to||
0104|068|H|get the most benefit from it. To help you remember, take it at||
0104|069|H|the same time(s) each day. Taking your last dose in the early||
0104|070|H|evening will help prevent you from having to get up in the middle||
0104|071|H|of the night to urinate. Consult your doctor or pharmacist if you||
0104|072|H|have questions about your dosing schedule.||
0104|073|H|   Do not increase your dose or use this drug more often or for||
0104|074|H|longer than prescribed. Your condition will not improve any||
0104|075|H|faster, and your risk of side effects will increase.||
0104|076|H|   When this medication is used for a long time, it may not work||
0104|077|H|as well. Talk with your doctor if this medication stops working||
0104|078|H|well.||
0104|079|H|   Tell your doctor if your condition lasts or gets worse.||
0104|080|B|||
0104|081|S|SIDE EFFECTS:  Dizziness, lightheadedness, or increased urination||
0104|082|S|may occur, especially during the first few days as your body||
0104|083|S|adjusts to the medication. Blurred vision, dry mouth, drowsiness,||
0104|084|S|loss of appetite, nausea, vomiting, diarrhea, or changes in taste||
0104|085|S|may also occur. If any of these effects last or get worse, tell||
0104|086|S|your doctor or pharmacist promptly.||
0104|087|S|   To reduce the risk of dizziness and lightheadedness, get up||
0104|088|S|slowly when rising from a sitting or lying position.||
0104|089|S|   Remember that this medication has been prescribed because your||
0104|090|S|doctor has judged that the benefit to you is greater than the||
0104|091|S|risk of side effects. Many people using this medication do not||
0104|092|S|have serious side effects.||
0104|093|S|   Tell your doctor right away if you have any serious side||
0104|094|S|effects, including: tingling of the hands/feet, hearing loss,||
0104|095|S|ringing in the ears, unusual tiredness, easy bleeding/bruising,||
0104|096|S|fast/irregular heartbeat, muscle cramps/pain, new or worsening||
0104|097|S|eye pain, decrease in vision, mental/mood changes (such as||
0104|098|S|confusion, difficulty concentrating), signs of liver disease||
0104|099|S|(such as nausea/vomiting that doesn't stop, stomach/abdominal||
0104|100|S|pain, yellowing eyes/skin, dark urine), signs of kidney problems||
0104|101|S|(such as painful urination, pink/bloody urine, change in the||
0104|102|S|amount of urine), signs of infection (such as sore throat that||
0104|103|S|doesn't go away, fever, chills).||
0104|104|S|   A very serious allergic reaction to this drug is rare.||
0104|105|S|However, get medical help right away if you notice any symptoms||
0104|106|S|of a serious allergic reaction, including: rash, itching/swelling||
0104|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0104|108|S|breathing.||
0104|109|S|   This is not a complete list of possible side effects. If you||
0104|110|S|notice other effects not listed above, contact your doctor or||
0104|111|S|pharmacist.||
0104|112|S|   In the US -||
0104|113|S|   Call your doctor for medical advice about side effects. You||
0104|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0104|115|S|www.fda.gov/medwatch.||
0104|116|S|   In Canada - Call your doctor for medical advice about side||
0104|117|S|effects. You may report side effects to Health Canada at||
0104|118|S|1-866-234-2345.||
0104|119|B|||
0104|120|P|PRECAUTIONS:  Before taking acetazolamide, tell your doctor or||
0104|121|P|pharmacist if you are allergic to it; or if you have any other||
0104|122|P|allergies. This product may contain inactive ingredients, which||
0104|123|P|can cause allergic reactions or other problems. Talk to your||
0104|124|P|pharmacist for more details.||
0104|125|P|   Before using this medication, tell your doctor or pharmacist||
0104|126|P|your medical history, especially of: adrenal gland problems (such||
0104|127|P|as Addison's disease), untreated mineral imbalance (such as low||
0104|128|P|sodium/potassium, hyperchloremic acidosis), dehydration, kidney||
0104|129|P|disease, liver disease, breathing problems (such as chronic||
0104|130|P|obstructive pulmonary disease-COPD, emphysema, lung infection),||
0104|131|P|diabetes, gout, narrow-angle glaucoma, overactive thyroid||
0104|132|P|(hyperthyroidism).||
0104|133|P|   While this medication can help you get used to high altitudes||
0104|134|P|and help you tolerate quick climbs, it cannot completely prevent||
0104|135|P|serious altitude sickness. Symptoms of serious altitude sickness||
0104|136|P|may include shortness of breath, mental/mood changes (such as||
0104|137|P|confusion, difficulty concentrating), lack of||
0104|138|P|coordination/staggering walk, severe tiredness, or severe||
0104|139|P|headache. If you develop any of these symptoms, it is very||
0104|140|P|important that you descend to a lower altitude as quickly as||
0104|141|P|possible to prevent serious, possibly fatal problems.||
0104|142|P|   This drug may make you dizzy or drowsy or blur your vision.||
0104|143|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0104|144|P|drowsy. Do not drive, use machinery, or do anything that needs||
0104|145|P|alertness or clear vision until you can do it safely. Limit||
0104|146|P|alcoholic beverages. Talk to your doctor if you are using||
0104|147|P|marijuana (cannabis).||
0104|148|P|   This drug may reduce the potassium levels in your blood. Your||
0104|149|P|doctor may instruct you to add potassium-rich foods to your diet||
0104|150|P|(such as bananas, orange juice) or prescribe potassium||
0104|151|P|supplements to prevent potassium loss. Ask your doctor for more||
0104|152|P|details.||
0104|153|P|   This drug may rarely make your blood sugar rise, which can||
0104|154|P|cause or worsen diabetes. Tell your doctor right away if you have||
0104|155|P|symptoms of high blood sugar such as increased thirst/urination.||
0104|156|P|   If you already have diabetes, check your blood sugar regularly||
0104|157|P|as directed and share the results with your doctor. This||
0104|158|P|medication may also lower your blood sugar. Symptoms of low blood||
0104|159|P|sugar include sudden sweating, shaking, fast heartbeat, hunger,||
0104|160|P|blurred vision, dizziness or tingling hands/feet. It is a good||
0104|161|P|habit to carry glucose tablets or gel to treat low blood sugar.||
0104|162|P|If you don't have these reliable forms of glucose, rapidly raise||
0104|163|P|your blood sugar by eating a quick source of sugar such as table||
0104|164|P|sugar, honey, or candy, or by drinking a glass of orange juice or||
0104|165|P|non-diet soda. Tell your doctor right away about the reaction and||
0104|166|P|the use of this product. To help prevent low blood sugar, eat||
0104|167|P|meals on a regular schedule, and do not skip meals.||
0104|168|P|   This medication may make you more sensitive to the sun. Limit||
0104|169|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0104|170|P|sunscreen and wear protective clothing when outdoors. Tell your||
0104|171|P|doctor right away if you get sunburned or have skin||
0104|172|P|blisters/redness.||
0104|173|P|   Before having surgery, tell your doctor or dentist about all||
0104|174|P|the products you use (including prescription drugs,||
0104|175|P|nonprescription drugs, and herbal products).||
0104|176|P|   Older adults may be more sensitive to the side effects of this||
0104|177|P|drug, especially dizziness and lightheadedness.||
0104|178|P|   During pregnancy, this medication should be used only when||
0104|179|P|clearly needed. Discuss the risks and benefits with your doctor.||
0104|180|P|   This medication passes into breast milk but is unlikely to||
0104|181|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0104|182|B|||
0104|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0104|184|I|medications work or increase your risk for serious side effects.||
0104|185|I|This document does not contain all possible drug interactions.||
0104|186|I|Keep a list of all the products you use (including||
0104|187|I|prescription/nonprescription drugs and herbal products) and share||
0104|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
0104|189|I|the dosage of any medicines without your doctor's approval.||
0104|190|I|   Some products that may interact with this drug include:||
0104|191|I|lithium, memantine, methenamine, orlistat, certain drugs used to||
0104|192|I|treat seizures (topiramate, zonisamide).||
0104|193|I|   Check the labels on all your medicines because they may||
0104|194|I|contain aspirin or aspirin-like drugs (salicylates), which can||
0104|195|I|cause serious side effects if taken in large doses with this||
0104|196|I|medication. However, if your doctor has told you to take low-dose||
0104|197|I|aspirin to prevent heart attack or stroke (usually 81-162||
0104|198|I|milligrams a day), you should keep taking the aspirin unless your||
0104|199|I|doctor tells you not to. Ask your doctor or pharmacist for more||
0104|200|I|details.||
0104|201|I|   Some products have ingredients that could worsen your||
0104|202|I|swelling. Tell your pharmacist what products you are using, and||
0104|203|I|ask how to use them safely (especially NSAIDs such as||
0104|204|I|ibuprofen/naproxen).||
0104|205|I|   This medication may interfere with certain lab tests, possibly||
0104|206|I|causing false test results. Make sure lab personnel and all your||
0104|207|I|doctors know you use this drug.||
0104|208|B|||
0104|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0104|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0104|211|O|poison control center right away. US residents can call||
0104|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0104|213|B|||
0104|214|N|NOTES:  Do not share this medication with others.||
0104|215|N|   Lab and/or medical tests (such as complete blood count,||
0104|216|N|potassium and sodium levels in the blood, liver function) may be||
0104|217|N|done while you are using this medication. Keep all medical and||
0104|218|N|lab appointments. Consult your doctor for more details.||
0104|219|B|||
0104|220|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0104|221|D|remember. If it is near the time for your next dose, skip the||
0104|222|D|missed dose. Take your next dose at the regular time. Do not||
0104|223|D|double the dose to catch up.||
0104|224|B|||
0104|225|R|STORAGE:  Store at room temperature away from light and moisture.||
0104|226|R|Do not store in the bathroom. Keep all medications away from||
0104|227|R|children and pets.||
0104|228|R|   Do not flush medications down the toilet or pour them into a||
0104|229|R|drain unless instructed to do so. Properly discard this product||
0104|230|R|when it is expired or no longer needed. Consult your pharmacist||
0104|231|R|or local waste disposal company.||
0104|232|B|||
0104|233|A|Information last revised September 2025.||
0104|234|A|Copyright(c) 2025 First Databank, Inc.||
0104|235|B|||
0105|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0105|002|Z|does NOT have all possible information about this product. This||
0105|003|Z|information does not assure that this product is safe, effective,||
0105|004|Z|or appropriate for you. This information is not individual||
0105|005|Z|medical advice and does not substitute for the advice of your||
0105|006|Z|health care professional. Always ask your health care||
0105|007|Z|professional for complete information about this product and your||
0105|008|Z|specific health needs.||
0105|009|B|||
0105|010|T|METHOCARBAMOL/ASPIRIN - ORAL||
0105|011|F|(METH-oh-KAR-ba-mol/AS-pir-in)||
0105|012|B|||
0105|013|C|COMMON BRAND NAME(S): Robaxisal||
0105|014|B|||
0105|015|U|USES:  This product is used to treat muscle spasm/pain.||
0105|016|U|Methocarbamol helps to relax the muscles. Aspirin helps to||
0105|017|U|decrease the pain.||
0105|018|B|||
0105|019|H|HOW TO USE:  Take this medication by mouth with or without food||
0105|020|H|as directed by your doctor. Do not increase your dose or use this||
0105|021|H|drug more often or for longer than prescribed. Your condition||
0105|022|H|will not improve any faster, and your risk of side effects will||
0105|023|H|increase. Take this medication with a full glass of water (8||
0105|024|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
0105|025|H|Do not lie down for at least 10 minutes after taking this||
0105|026|H|medication. If you have stomach upset while taking this||
0105|027|H|medication, take it with food or milk.||
0105|028|H|   The dosage is based on your medical condition and response to||
0105|029|H|treatment. Use the smallest effective dose.||
0105|030|H|   Pain medications work best if they are used as the first signs||
0105|031|H|of pain occur. If you wait until the symptoms have worsened, the||
0105|032|H|medication may not work as well.||
0105|033|H|   Tell your doctor if your condition lasts or gets worse.||
0105|034|B|||
0105|035|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, stomach||
0105|036|S|upset, nausea/vomiting, heartburn, or blurred vision may occur.||
0105|037|S|If any of these effects last or get worse, tell your doctor or||
0105|038|S|pharmacist promptly.||
0105|039|S|   Remember that this medication has been prescribed because your||
0105|040|S|doctor has judged that the benefit to you is greater than the||
0105|041|S|risk of side effects. Many people using this medication do not||
0105|042|S|have serious side effects.||
0105|043|S|   Tell your doctor right away if you have any serious side||
0105|044|S|effects, including: nausea/vomiting that doesn't stop, easy||
0105|045|S|bruising/bleeding, dark urine, yellowing eyes/skin, hearing||
0105|046|S|problems (such as ringing in the ears, hearing loss), signs of||
0105|047|S|kidney problems (such as change in the amount of urine),||
0105|048|S|fast/pounding heartbeat, unusual tiredness, fainting, mental/mood||
0105|049|S|changes (such as confusion, forgetfulness).||
0105|050|S|   This drug may rarely cause serious (rarely fatal) bleeding||
0105|051|S|from the stomach or intestines. If you notice any of the||
0105|052|S|following unlikely but serious side effects, stop taking this||
0105|053|S|medication and consult your doctor or pharmacist right away:||
0105|054|S|stomach/abdominal pain that doesn't go away, black stool, vomit||
0105|055|S|that looks like coffee grounds.||
0105|056|S|   A very serious allergic reaction to this drug is rare.||
0105|057|S|However, get medical help right away if you notice any symptoms||
0105|058|S|of a serious allergic reaction, including: fever, swollen lymph||
0105|059|S|nodes, rash, itching/swelling (especially of the||
0105|060|S|face/tongue/throat), severe dizziness, trouble breathing.||
0105|061|S|   This is not a complete list of possible side effects. If you||
0105|062|S|notice other effects not listed above, contact your doctor or||
0105|063|S|pharmacist.||
0105|064|S|   In the US -||
0105|065|S|   Call your doctor for medical advice about side effects. You||
0105|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0105|067|S|www.fda.gov/medwatch.||
0105|068|S|   In Canada - Call your doctor for medical advice about side||
0105|069|S|effects. You may report side effects to Health Canada at||
0105|070|S|1-866-234-2345.||
0105|071|B|||
0105|072|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0105|073|P|pharmacist if you are allergic to methocarbamol or aspirin; or to||
0105|074|P|nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen);||
0105|075|P|or to other salicylates (such as choline salicylate); or if you||
0105|076|P|have any other allergies. This product may contain inactive||
0105|077|P|ingredients, which can cause allergic reactions or other||
0105|078|P|problems. Talk to your pharmacist for more details.||
0105|079|P|   Before using this medication, tell your doctor or pharmacist||
0105|080|P|your medical history, especially of: asthma (including a history||
0105|081|P|of worsening breathing with runny/stuffy nose after taking||
0105|082|P|aspirin or other NSAIDs), growths in the nose (nasal polyps),||
0105|083|P|stomach/intestine/esophagus problems (such as ulcers, heartburn),||
0105|084|P|kidney disease, liver disease, bleeding/blood clotting disorders||
0105|085|P|(such as hemophilia, von Willebrand disease, thrombocytopenia),||
0105|086|P|certain enzyme deficiencies (such as pyruvate kinase, G6PD||
0105|087|P|deficiency), gout.||
0105|088|P|   Before having surgery, tell your doctor or dentist about all||
0105|089|P|the products you use (including prescription drugs,||
0105|090|P|nonprescription drugs, and herbal products).||
0105|091|P|   This drug may make you dizzy or drowsy or blur your vision.||
0105|092|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0105|093|P|drowsy. Do not drive, use machinery, or do anything that needs||
0105|094|P|alertness or clear vision until you can do it safely. Avoid||
0105|095|P|alcoholic beverages. Talk to your doctor if you are using||
0105|096|P|marijuana (cannabis).||
0105|097|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0105|098|P|and tobacco, especially when combined with this medicine, may||
0105|099|P|increase your risk for stomach bleeding. Avoid alcohol and stop||
0105|100|P|smoking. Consult your doctor or pharmacist for more information.||
0105|101|P|   This drug contains aspirin. Children and teenagers less than||
0105|102|P|18 years old should not take aspirin if they have chickenpox,||
0105|103|P|flu, or any undiagnosed illness or if they have recently received||
0105|104|P|a vaccine. In these cases, taking aspirin increases the risk of||
0105|105|P|Reye's syndrome, a rare but serious illness.||
0105|106|P|   Older adults may be more sensitive to the side effects of this||
0105|107|P|drug, especially stomach/intestinal bleeding and ulcers,||
0105|108|P|drowsiness, and confusion. Drowsiness and confusion can increase||
0105|109|P|the risk of falling.||
0105|110|P|   Before using this medication, women of childbearing age should||
0105|111|P|talk with their doctor(s) about the benefits and risks. Tell your||
0105|112|P|doctor if you are pregnant or if you plan to become pregnant.||
0105|113|P|This medication may harm an unborn baby and cause problems with||
0105|114|P|normal labor/delivery. It is not recommended for use in pregnancy||
0105|115|P|from 20 weeks until delivery. If your doctor decides that you||
0105|116|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0105|117|P|you should use the lowest effective dose for the shortest||
0105|118|P|possible time. You should not use this medication after 30 weeks||
0105|119|P|of pregnancy.||
0105|120|P|   It is unknown if methocarbamol passes into breast milk.||
0105|121|P|Aspirin passes into breast milk and may have undesirable effects||
0105|122|P|on a nursing infant. Breastfeeding is not recommended while using||
0105|123|P|this medication. Consult your doctor before breastfeeding.||
0105|124|B|||
0105|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0105|126|I|medications work or increase your risk for serious side effects.||
0105|127|I|This document does not contain all possible drug interactions.||
0105|128|I|Keep a list of all the products you use (including||
0105|129|I|prescription/nonprescription drugs and herbal products) and share||
0105|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
0105|131|I|the dosage of any medicines without your doctor's approval.||
0105|132|I|   Some products that may interact with this drug include:||
0105|133|I|dichlorphenamide, mifepristone, corticosteroids (such as||
0105|134|I|prednisone).||
0105|135|I|   This medication may increase the risk of bleeding when taken||
0105|136|I|with other drugs that also may cause bleeding. Examples include||
0105|137|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0105|138|I|dabigatran/enoxaparin/warfarin, among others.||
0105|139|I|   Check all prescription and nonprescription medicine labels||
0105|140|I|carefully since many medications contain pain relievers/fever||
0105|141|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
0105|142|I|naproxen). These drugs are similar to this medication and may||
0105|143|I|increase your risk of side effects if taken together. Ask your||
0105|144|I|doctor or pharmacist for more details.||
0105|145|I|   Tell your doctor or pharmacist if you are taking other||
0105|146|I|products that cause drowsiness such as opioid pain or cough||
0105|147|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0105|148|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0105|149|I|lorazepam, zolpidem), other muscle relaxants (such as||
0105|150|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0105|151|I|cetirizine, diphenhydramine).||
0105|152|I|   Check the labels on all your medicines (such as allergy or||
0105|153|I|cough-and-cold products) because they may contain ingredients||
0105|154|I|that cause drowsiness. Ask your pharmacist about using those||
0105|155|I|products safely.||
0105|156|I|   This medication may interfere with certain lab tests (such as||
0105|157|I|5-HIAA/VMA urine screening tests), possibly causing false test||
0105|158|I|results. Make sure lab personnel and all your doctors know you||
0105|159|I|use this drug.||
0105|160|B|||
0105|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0105|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0105|163|O|poison control center right away. US residents can call||
0105|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0105|165|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
0105|166|O|ringing in the ears, seizures.||
0105|167|B|||
0105|168|N|NOTES:  Do not share this medication with others.||
0105|169|N|   This medication has been prescribed for your current condition||
0105|170|N|only. Do not use it later for another condition unless your||
0105|171|N|doctor directs you to do so. A different medication may be||
0105|172|N|necessary in that case.||
0105|173|B|||
0105|174|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0105|175|D|remember. If it is near the time of the next dose, skip the||
0105|176|D|missed dose. Take your next dose at the regular time. Do not||
0105|177|D|double the dose to catch up.||
0105|178|B|||
0105|179|R|STORAGE:  Store at room temperature away from light and moisture.||
0105|180|R|Do not store in the bathroom. Keep all medications away from||
0105|181|R|children and pets.||
0105|182|R|   Do not flush medications down the toilet or pour them into a||
0105|183|R|drain unless instructed to do so. Properly discard this product||
0105|184|R|when it is expired or no longer needed. Consult your pharmacist||
0105|185|R|or local waste disposal company.||
0105|186|B|||
0105|187|A|Information last revised May 2024.||
0105|188|A|Copyright(c) 2025 First Databank, Inc.||
0105|189|B|||
0106|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0106|002|Z|does NOT have all possible information about this product. This||
0106|003|Z|information does not assure that this product is safe, effective,||
0106|004|Z|or appropriate for you. This information is not individual||
0106|005|Z|medical advice and does not substitute for the advice of your||
0106|006|Z|health care professional. Always ask your health care||
0106|007|Z|professional for complete information about this product and your||
0106|008|Z|specific health needs.||
0106|009|B|||
0106|010|T|ASCORBIC ACID - ORAL||
0106|011|F|(as-KORE-bik AS-id)||
0106|012|B|||
0106|013|C|COMMON BRAND NAME(S): Cecon, Vitamin C||
0106|014|B|||
0106|015|U|USES:  Ascorbic acid (vitamin C) is used to prevent or treat low||
0106|016|U|levels of vitamin C in people who do not get enough of the||
0106|017|U|vitamin from their diets. Most people who eat a normal diet do||
0106|018|U|not need extra ascorbic acid. Low levels of vitamin C can result||
0106|019|U|in a condition called scurvy. Scurvy may cause symptoms such as||
0106|020|U|rash, muscle weakness, joint pain, tiredness, or tooth loss.||
0106|021|U|   Vitamin C plays an important role in the body. It is needed to||
0106|022|U|maintain the health of skin, cartilage, teeth, bone, and blood||
0106|023|U|vessels. It is also used to protect your body's cells from||
0106|024|U|damage. It is known as an antioxidant.||
0106|025|B|||
0106|026|V|OTHER USES:  This section contains uses of this drug that are not||
0106|027|V|listed in the approved professional labeling for the drug but||
0106|028|V|that may be prescribed by your health care professional. Use this||
0106|029|V|drug for a condition that is listed in this section only if it||
0106|030|V|has been so prescribed by your health care professional.||
0106|031|V|   This vitamin may also be used with other vitamins for a||
0106|032|V|certain eye condition (macular degeneration).||
0106|033|B|||
0106|034|H|HOW TO USE:  Take this vitamin by mouth with or without food,||
0106|035|H|usually 1 to 2 times daily. Follow all directions on the product||
0106|036|H|package, or take as directed by your doctor. Take this product||
0106|037|H|with a full glass of water (8 ounces/240 milliliters) unless your||
0106|038|H|doctor directs you otherwise.||
0106|039|H|   If you are taking the extended-release capsules or||
0106|040|H|delayed-release tablets, swallow them whole. Do not crush or chew||
0106|041|H|the extended-release capsules or tablets or delayed-release||
0106|042|H|tablets. Doing so can release all of the drug at once, increasing||
0106|043|H|the risk of side effects.||
0106|044|H|   If you are taking the wafers or chewable tablets, chew them||
0106|045|H|thoroughly and then swallow. If you are taking the lozenges,||
0106|046|H|place the lozenge in your mouth and allow it to slowly dissolve.||
0106|047|H|   If you are taking the powder, mix it thoroughly in the proper||
0106|048|H|amount of liquid or soft food and stir well. Take all of the||
0106|049|H|mixture right away. Do not prepare a supply for future use. If||
0106|050|H|you are using the liquid form of this vitamin, carefully measure||
0106|051|H|the dose using a special measuring device/spoon. Do not use a||
0106|052|H|household spoon because you may not get the correct dose.||
0106|053|H|   Dosage is based on your medical condition and response to||
0106|054|H|treatment.||
0106|055|H|   Use this vitamin regularly to get the most benefit from it. To||
0106|056|H|help you remember, take it at the same time(s) each day.||
0106|057|H|   If you think you may have a serious medical problem, get||
0106|058|H|medical help right away.||
0106|059|B|||
0106|060|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, abdominal cramps/pain,||
0106|061|S|or heartburn may occur. If any of these effects last or get||
0106|062|S|worse, tell your doctor or pharmacist promptly.||
0106|063|S|   If your doctor has directed you to use this medication,||
0106|064|S|remember that your doctor has judged that the benefit to you is||
0106|065|S|greater than the risk of side effects. Many people using this||
0106|066|S|medication do not have serious side effects.||
0106|067|S|   Tell your doctor right away if you have any serious side||
0106|068|S|effects, including: painful urination, pink/bloody urine.||
0106|069|S|   A very serious allergic reaction to this drug is rare.||
0106|070|S|However, get medical help right away if you notice any symptoms||
0106|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0106|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0106|073|S|breathing.||
0106|074|S|   This is not a complete list of possible side effects. If you||
0106|075|S|notice other effects not listed above, contact your doctor or||
0106|076|S|pharmacist.||
0106|077|S|   In the US -||
0106|078|S|   Call your doctor for medical advice about side effects. You||
0106|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0106|080|S|www.fda.gov/medwatch.||
0106|081|S|   In Canada - Call your doctor for medical advice about side||
0106|082|S|effects. You may report side effects to Health Canada at||
0106|083|S|1-866-234-2345.||
0106|084|B|||
0106|085|P|PRECAUTIONS:  Before taking ascorbic acid, tell your doctor or||
0106|086|P|pharmacist if you have any allergies. This product may contain||
0106|087|P|inactive ingredients (such as peanut/soy), which can cause||
0106|088|P|allergic reactions or other problems. Talk to your pharmacist for||
0106|089|P|more details.||
0106|090|P|   Before using this vitamin, tell your doctor or pharmacist your||
0106|091|P|medical history, especially of: kidney disease (such as kidney||
0106|092|P|stones), a certain enzyme deficiency (G6PD deficiency).||
0106|093|P|   Before having surgery, tell your doctor or dentist about all||
0106|094|P|the products you use (including prescription drugs,||
0106|095|P|nonprescription drugs, and herbal products).||
0106|096|P|   During pregnancy, this vitamin has been found to be safe when||
0106|097|P|used in recommended doses. Higher doses should be used during||
0106|098|P|pregnancy only if clearly needed. Discuss the risks and benefits||
0106|099|P|with your doctor.||
0106|100|P|   This vitamin passes into breast milk and is considered to be||
0106|101|P|safe during breastfeeding when used in recommended doses. Consult||
0106|102|P|your doctor for more information.||
0106|103|B|||
0106|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0106|105|I|medications work or increase your risk for serious side effects.||
0106|106|I|This document does not contain all possible drug interactions.||
0106|107|I|Keep a list of all the products you use (including||
0106|108|I|prescription/nonprescription drugs and herbal products) and share||
0106|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
0106|110|I|the dosage of any medicines without your doctor's approval.||
0106|111|I|   This vitamin may interfere with certain lab tests (including||
0106|112|I|certain urine glucose tests), possibly causing false test||
0106|113|I|results. Make sure lab personnel and all your doctors know you||
0106|114|I|use this drug.||
0106|115|B|||
0106|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0106|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0106|118|O|poison control center right away. US residents can call||
0106|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0106|120|B|||
0106|121|N|NOTES:  Keep all medical and lab appointments.||
0106|122|N|   This product is not a substitute for a proper diet. It is best||
0106|123|N|to get your vitamins from healthy foods. Ascorbic acid is||
0106|124|N|commonly found in citrus fruit (such as oranges), tomatoes,||
0106|125|N|brussels sprouts, cauliflower, and broccoli, among others.||
0106|126|N|Consult your doctor, pharmacist, or nutritionist for more||
0106|127|N|details.||
0106|128|B|||
0106|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0106|130|D|remember. If it is near the time of the next dose, skip the||
0106|131|D|missed dose. Take your next dose at the regular time. Do not||
0106|132|D|double the dose to catch up.||
0106|133|B|||
0106|134|R|STORAGE:  Different brands of this vitamin have different storage||
0106|135|R|needs. Check the product package for instructions on how to store||
0106|136|R|your brand, or ask your pharmacist. Keep all medications away||
0106|137|R|from children and pets.||
0106|138|R|   Do not flush medications down the toilet or pour them into a||
0106|139|R|drain unless instructed to do so. Properly discard this product||
0106|140|R|when it is expired or no longer needed. Consult your pharmacist||
0106|141|R|or local waste disposal company.||
0106|142|B|||
0106|143|A|Information last revised September 2025.||
0106|144|A|Copyright(c) 2025 First Databank, Inc.||
0106|145|B|||
0107|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0107|002|Z|does NOT have all possible information about this product. This||
0107|003|Z|information does not assure that this product is safe, effective,||
0107|004|Z|or appropriate for you. This information is not individual||
0107|005|Z|medical advice and does not substitute for the advice of your||
0107|006|Z|health care professional. Always ask your health care||
0107|007|Z|professional for complete information about this product and your||
0107|008|Z|specific health needs.||
0107|009|B|||
0107|010|T|AURANOFIN - ORAL||
0107|011|F|(aw-RAN-o-fin)||
0107|012|B|||
0107|013|C|COMMON BRAND NAME(S): Ridaura||
0107|014|B|||
0107|015|W|WARNING:  This medication can cause serious (sometimes fatal)||
0107|016|W|side effects, including diarrhea that doesn't go away, blood cell||
0107|017|W|problems (such as anemia, low white blood cells/platelets),||
0107|018|W|kidney problems, rash, itching, or mouth sores/irritation||
0107|019|W|(stomatitis). Low white blood cells can increase your risk of||
0107|020|W|infection. See Side Effects section for more details. Tell your||
0107|021|W|doctor right away if you develop any of these side effects.||
0107|022|W|   Your doctor will be closely monitoring certain lab tests (such||
0107|023|W|as white blood cells, platelets) before you start taking this||
0107|024|W|medication and while you are taking it. It is important that you||
0107|025|W|keep all medical/lab appointments.||
0107|026|B|||
0107|027|U|USES:  This medication is used as part of a complete treatment||
0107|028|U|program including non-drug therapies (such as rest, physical||
0107|029|U|therapy) to treat active rheumatoid arthritis. It is used to||
0107|030|U|treat patients with severe rheumatoid arthritis who have not||
0107|031|U|responded to or cannot take other medications. Auranofin is a||
0107|032|U|gold compound.||
0107|033|U|   Auranofin is not a true pain reliever (such as like aspirin)||
0107|034|U|but it is thought to decrease pain that occurs with arthritis by||
0107|035|U|decreasing inflammation. It is known as a disease-modifying||
0107|036|U|antirheumatic drug (DMARD). It decreases morning stiffness and||
0107|037|U|pain/swelling in joints and can increase grip strength.||
0107|038|B|||
0107|039|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0107|040|H|from your pharmacist before you start taking auranofin and each||
0107|041|H|time you get a refill. If you have any questions, ask your doctor||
0107|042|H|or pharmacist.||
0107|043|H|   Take this medication by mouth with or without food as directed||
0107|044|H|by your doctor, usually once or twice a day. The dosage is based||
0107|045|H|on your medical condition and response to treatment. To decrease||
0107|046|H|side effects such as upset stomach, your doctor may start you at||
0107|047|H|a low dose (once a day) and slowly increase to twice a day. Do||
0107|048|H|not increase your dose or take this medication more often without||
0107|049|H|your doctor's approval. Your condition will not improve any||
0107|050|H|faster, and the risk of serious side effects may be increased.||
0107|051|H|   Take this medication regularly in order to get the most||
0107|052|H|benefit from it. To help you remember, take it at the same||
0107|053|H|time(s) each day.||
0107|054|H|   If you have been receiving gold injections, you can usually||
0107|055|H|start taking gold by mouth as soon as you stop the injections. If||
0107|056|H|you are changing over from penicillamine, you will usually need||
0107|057|H|to wait 1 month after stopping the penicillamine before starting||
0107|058|H|auranofin. Ask your doctor for more details.||
0107|059|H|   It may take 3 to 4 months of treatment before you see the full||
0107|060|H|benefits of this medication.||
0107|061|H|   Tell your doctor if your condition lasts or gets worse.||
0107|062|B|||
0107|063|S|SIDE EFFECTS:  Diarrhea, frequent/loose stools, stomach/abdominal||
0107|064|S|cramping, nausea, loss of appetite, heartburn, and headache may||
0107|065|S|occur. If any of these effects last or get worse, tell your||
0107|066|S|doctor or pharmacist promptly.||
0107|067|S|   Remember that this medication has been prescribed because your||
0107|068|S|doctor has judged that the benefit to you is greater than the||
0107|069|S|risk of side effects. Many people using this medication do not||
0107|070|S|have serious side effects.||
0107|071|S|   Tell your doctor right away if you have any serious side||
0107|072|S|effects, including: eye redness/pain, hair loss,||
0107|073|S|numbness/tingling of arms/legs, signs of low blood count (such as||
0107|074|S|fast/pounding heartbeat, pale skin, unusual tiredness), easy||
0107|075|S|bleeding/bruising, black/bloody stools, cough that doesn't go||
0107|076|S|away, mucus/pus/blood in watery diarrhea, dizziness, signs of||
0107|077|S|infection (such as sore throat that doesn't go away, fever,||
0107|078|S|chills), severe stomach/abdominal pain, change in the||
0107|079|S|amount/color of urine, vomit that looks like coffee grounds,||
0107|080|S|yellowing eyes/skin.||
0107|081|S|   This medication may cause mouth/lip/throat sores (stomatitis).||
0107|082|S|Tell your doctor if you notice a metallic taste in your mouth.||
0107|083|S|This could be the first sign of stomatitis. Rinsing your mouth||
0107|084|S|with a mild salt solution may provide some relief. Discuss with||
0107|085|S|your doctor.||
0107|086|S|   A very serious allergic reaction to this drug is rare.||
0107|087|S|However, get medical help right away if you notice any symptoms||
0107|088|S|of a serious allergic reaction, including: itching/swelling||
0107|089|S|(especially of the face/tongue/throat), rash, severe dizziness,||
0107|090|S|trouble breathing.||
0107|091|S|   Auranofin can commonly cause a rash that is usually not||
0107|092|S|serious. However, you may not be able to tell it apart from a||
0107|093|S|rare rash that could be a sign of a severe reaction. Get medical||
0107|094|S|help right away if you develop any rash.||
0107|095|S|   This is not a complete list of possible side effects. If you||
0107|096|S|notice other effects not listed above, contact your doctor or||
0107|097|S|pharmacist.||
0107|098|S|   In the US -||
0107|099|S|   Call your doctor for medical advice about side effects. You||
0107|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0107|101|S|www.fda.gov/medwatch.||
0107|102|S|   In Canada - Call your doctor for medical advice about side||
0107|103|S|effects. You may report side effects to Health Canada at||
0107|104|S|1-866-234-2345.||
0107|105|B|||
0107|106|P|PRECAUTIONS:  Before taking auranofin, tell your doctor or||
0107|107|P|pharmacist if you are allergic to it; or to any other gold or||
0107|108|P|heavy metal compound; or if you have any other allergies. This||
0107|109|P|product may contain inactive ingredients, which can cause||
0107|110|P|allergic reactions or other problems. Talk to your pharmacist for||
0107|111|P|more details.||
0107|112|P|   Before using this medication, tell your doctor or pharmacist||
0107|113|P|your medical history, especially of: reaction to gold compound||
0107|114|P|(such as blood disorders, kidney problems, lung problems,||
0107|115|P|stomach/intestinal problems), bleeding problems, blood disorders||
0107|116|P|(such as bone marrow depression), colitis/inflammatory bowel||
0107|117|P|disease, eczema, certain lung problem (fibrosis), kidney disease,||
0107|118|P|liver disease, SLE (systemic lupus erythematosus), recent||
0107|119|P|radiation therapy.||
0107|120|P|   This medication may make you more sensitive to the sun. Limit||
0107|121|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0107|122|P|sunscreen and wear protective clothing when outdoors. Tell your||
0107|123|P|doctor right away if you get sunburned or have skin||
0107|124|P|blisters/redness.||
0107|125|P|   Before having surgery, tell your doctor or dentist about all||
0107|126|P|the products you use (including prescription drugs,||
0107|127|P|nonprescription drugs, and herbal products).||
0107|128|P|   Tell your doctor if you are pregnant or plan to become||
0107|129|P|pregnant. You should not become pregnant while using auranofin.||
0107|130|P|Auranofin may harm an unborn baby. If you become pregnant, talk||
0107|131|P|to your doctor right away about the risks and benefits of this||
0107|132|P|medication.||
0107|133|P|   This medication passes into breast milk and may have||
0107|134|P|undesirable effects on a nursing infant. Consult your doctor||
0107|135|P|before breastfeeding.||
0107|136|B|||
0107|137|I|DRUG INTERACTIONS:  See also How to Use section.||
0107|138|I|   Drug interactions may change how your medications work or||
0107|139|I|increase your risk for serious side effects. This document does||
0107|140|I|not contain all possible drug interactions. Keep a list of all||
0107|141|I|the products you use (including prescription/nonprescription||
0107|142|I|drugs and herbal products) and share it with your doctor and||
0107|143|I|pharmacist. Do not start, stop, or change the dosage of any||
0107|144|I|medicines without your doctor's approval.||
0107|145|I|   This medication may interfere with certain lab tests (such as||
0107|146|I|tuberculin skin test), possibly causing false test results. Make||
0107|147|I|sure lab personnel and all your doctors know you use this drug.||
0107|148|B|||
0107|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0107|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0107|151|O|poison control center right away. US residents can call||
0107|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0107|153|B|||
0107|154|N|NOTES:  Do not share this medication with others.||
0107|155|N|   Lab and/or medical tests (such as complete blood count,||
0107|156|N|liver/kidney function, urine tests) should be done while you are||
0107|157|N|taking this medication. Keep all medical and lab appointments.||
0107|158|N|Consult your doctor for more details.||
0107|159|B|||
0107|160|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0107|161|D|remember. If it is near the time of the next dose, skip the||
0107|162|D|missed dose. Take your next dose at the regular time. Do not||
0107|163|D|double the dose to catch up.||
0107|164|B|||
0107|165|R|STORAGE:  Store at room temperature away from light and moisture.||
0107|166|R|Do not store in the bathroom. Keep all medications away from||
0107|167|R|children and pets.||
0107|168|R|   Do not flush medications down the toilet or pour them into a||
0107|169|R|drain unless instructed to do so. Properly discard this product||
0107|170|R|when it is expired or no longer needed. Consult your pharmacist||
0107|171|R|or local waste disposal company.||
0107|172|B|||
0107|173|A|Information last revised April 2025.||
0107|174|A|Copyright(c) 2025 First Databank, Inc.||
0107|175|B|||
0108|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0108|002|Z|does NOT have all possible information about this product. This||
0108|003|Z|information does not assure that this product is safe, effective,||
0108|004|Z|or appropriate for you. This information is not individual||
0108|005|Z|medical advice and does not substitute for the advice of your||
0108|006|Z|health care professional. Always ask your health care||
0108|007|Z|professional for complete information about this product and your||
0108|008|Z|specific health needs.||
0108|009|B|||
0108|010|T|AZATHIOPRINE - ORAL||
0108|011|F|(AY-za-THYE-oh-preen)||
0108|012|B|||
0108|013|C|COMMON BRAND NAME(S): Imuran||
0108|014|B|||
0108|015|W|WARNING:  Azathioprine may rarely increase your risk of||
0108|016|W|developing certain types of cancer (such as lymphoma, skin||
0108|017|W|cancer). This risk is higher in people using azathioprine after||
0108|018|W|an organ transplant and in children/young adults being treated||
0108|019|W|for certain bowel diseases (such as Crohn's disease, ulcerative||
0108|020|W|colitis). Keep all medical and lab appointments. Tell your doctor||
0108|021|W|right away if you develop any of the following symptoms: unusual||
0108|022|W|skin changes, change in the appearance/size of moles, unusual||
0108|023|W|growths/lumps, swollen lymph nodes, swollen abdomen, unexplained||
0108|024|W|weight loss, night sweats.||
0108|025|W|   This medication may decrease bone marrow function, an effect||
0108|026|W|that may lead to a low number of blood cells such as red cells,||
0108|027|W|white cells, and platelets. This effect can cause anemia,||
0108|028|W|decrease your body's ability to fight an infection, or cause easy||
0108|029|W|bruising/bleeding. Tell your doctor right away if you develop any||
0108|030|W|of the following symptoms: unusual tiredness, pale skin, signs of||
0108|031|W|infection (such as sore throat that doesn't go away, fever,||
0108|032|W|chills), easy bruising/bleeding.||
0108|033|B|||
0108|034|U|USES:  Azathioprine is used to prevent organ rejection in people||
0108|035|U|who have received a kidney transplant. It is usually taken along||
0108|036|U|with other medications to allow your new kidney to function||
0108|037|U|normally. Azathioprine is also used to treat rheumatoid||
0108|038|U|arthritis. In this condition, the body's defense system (immune||
0108|039|U|system) attacks healthy joints. Azathioprine belongs to a class||
0108|040|U|of drugs known as immunosuppressants. It works by weakening the||
0108|041|U|immune system to help your body accept the new kidney as if it||
0108|042|U|were your own (in the case of an organ transplant) or to prevent||
0108|043|U|further damage to your joints (in the case of rheumatoid||
0108|044|U|arthritis).||
0108|045|U|   Talk to your doctor about the risks and benefits of||
0108|046|U|azathioprine, especially when used by children and young adults.||
0108|047|B|||
0108|048|V|OTHER USES:  This section contains uses of this drug that are not||
0108|049|V|listed in the approved professional labeling for the drug but||
0108|050|V|that may be prescribed by your health care professional. Use this||
0108|051|V|drug for a condition that is listed in this section only if it||
0108|052|V|has been so prescribed by your health care professional.||
0108|053|V|   This drug may also be used to reduce the risk of rejection of||
0108|054|V|other transplanted organs. It may also be used for certain types||
0108|055|V|of bowel conditions (Crohn's disease, ulcerative colitis), and||
0108|056|V|other immune system problems.||
0108|057|B|||
0108|058|H|HOW TO USE:  Take this medication by mouth as directed by your||
0108|059|H|doctor, usually once or twice daily. Take this medication with||
0108|060|H|food to reduce stomach upset.||
0108|061|H|   The dosage is based on your medical condition, weight, and||
0108|062|H|response to treatment. Do not increase your dose or use this drug||
0108|063|H|more often or for longer than prescribed. Your condition will not||
0108|064|H|improve any faster, and your risk of serious side effects will||
0108|065|H|increase.||
0108|066|H|   Use this medication regularly to get the most benefit from it.||
0108|067|H|To help you remember, take it at the same time(s) each day.||
0108|068|H|   For the treatment of arthritis, it may take up to 2 months||
0108|069|H|before your symptoms get better. Tell your doctor if your||
0108|070|H|condition does not get better after 3 months of treatment.||
0108|071|H|   Since this drug can be absorbed through the skin and lungs and||
0108|072|H|may harm an unborn baby, women who are pregnant or who may become||
0108|073|H|pregnant should not handle this medication or breathe the dust||
0108|074|H|from the tablets.||
0108|075|B|||
0108|076|S|SIDE EFFECTS:  See also Warning section.||
0108|077|S|   Nausea or vomiting may occur. Taking this medication after||
0108|078|S|meals may help lessen these effects. Temporary hair loss may also||
0108|079|S|occur. If any of these effects last or get worse, tell your||
0108|080|S|doctor or pharmacist promptly.||
0108|081|S|   People using this medication may have serious side effects.||
0108|082|S|However, you have been prescribed this drug because your doctor||
0108|083|S|has judged that the benefit to you is greater than the risk of||
0108|084|S|side effects. Careful monitoring by your doctor may decrease your||
0108|085|S|risk.||
0108|086|S|   Tell your doctor right away if you have any serious side||
0108|087|S|effects, including: diarrhea, new or worsening joint/muscle pain.||
0108|088|S|   Get medical help right away if you have any very serious side||
0108|089|S|effects, including: symptoms of liver disease (such as||
0108|090|S|nausea/vomiting that doesn't stop, stomach/abdominal pain, dark||
0108|091|S|urine, yellowing eyes/skin).||
0108|092|S|   This medication may increase your risk of getting a rare but||
0108|093|S|very serious (possibly fatal) brain infection (progressive||
0108|094|S|multifocal leukoencephalopathy-PML). Get medical help right away||
0108|095|S|if you have any of these side effects: clumsiness, loss of||
0108|096|S|coordination/balance, weakness, sudden change in your thinking||
0108|097|S|(such as confusion, difficulty concentrating, memory loss),||
0108|098|S|difficulty talking/walking, seizure, vision changes.||
0108|099|S|   A very serious allergic reaction to this drug is rare.||
0108|100|S|However, get medical help right away if you notice any symptoms||
0108|101|S|of a serious allergic reaction, including: rash, itching/swelling||
0108|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0108|103|S|breathing.||
0108|104|S|   This is not a complete list of possible side effects. If you||
0108|105|S|notice other effects not listed above, contact your doctor or||
0108|106|S|pharmacist.||
0108|107|S|   In the US -||
0108|108|S|   Call your doctor for medical advice about side effects. You||
0108|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0108|110|S|www.fda.gov/medwatch.||
0108|111|S|   In Canada - Call your doctor for medical advice about side||
0108|112|S|effects. You may report side effects to Health Canada at||
0108|113|S|1-866-234-2345.||
0108|114|B|||
0108|115|P|PRECAUTIONS:  Before taking azathioprine, tell your doctor or||
0108|116|P|pharmacist if you are allergic to it, or to mercaptopurine; or if||
0108|117|P|you have any other allergies. This product may contain inactive||
0108|118|P|ingredients, which can cause allergic reactions or other||
0108|119|P|problems. Talk to your pharmacist for more details.||
0108|120|P|   Before using this medication, tell your doctor or pharmacist||
0108|121|P|your medical history, especially of: kidney disease, liver||
0108|122|P|disease, cancer, certain enzyme disorders (TPMT deficiency,||
0108|123|P|NUDT15 deficiency).||
0108|124|P|   This medication may increase your risk of developing skin||
0108|125|P|cancer. Limit your time in the sun. Avoid tanning booths and||
0108|126|P|sunlamps. Use sunscreen and wear protective clothing when||
0108|127|P|outdoors. Your doctor may direct you to avoid phototherapy while||
0108|128|P|you use this product. Ask your doctor for details.||
0108|129|P|   Azathioprine can make you more likely to get infections or may||
0108|130|P|make current infections worse. Stay away from anyone who has an||
0108|131|P|infection that may easily spread (such as chickenpox, COVID-19,||
0108|132|P|measles, flu). Talk to your doctor if you have been exposed to an||
0108|133|P|infection or for more details.||
0108|134|P|   Before having surgery, tell your doctor or dentist about all||
0108|135|P|the products you use (including prescription drugs,||
0108|136|P|nonprescription drugs, and herbal products).||
0108|137|P|   Tell your health care professional that you are using||
0108|138|P|azathioprine before having any immunizations/vaccinations. Avoid||
0108|139|P|contact with people who have recently received live vaccines||
0108|140|P|(such as flu vaccine inhaled through the nose).||
0108|141|P|   To lower the chance of getting cut, bruised, or injured, use||
0108|142|P|caution with sharp objects like razors and nail cutters, and||
0108|143|P|avoid activities such as contact sports.||
0108|144|P|   Since this drug can be absorbed through the skin and lungs and||
0108|145|P|may harm an unborn baby, women who are pregnant or who may become||
0108|146|P|pregnant should not handle this medication or breathe the dust||
0108|147|P|from the tablets.||
0108|148|P|   Tell your doctor if you are pregnant or plan to become||
0108|149|P|pregnant. You should not become pregnant while using||
0108|150|P|azathioprine. Azathioprine may harm an unborn baby. Ask about||
0108|151|P|reliable forms of birth control while using this medication. If||
0108|152|P|you become pregnant, talk to your doctor right away about the||
0108|153|P|risks and benefits of this medication.||
0108|154|P|   This medication passes into breast milk and may have||
0108|155|P|undesirable effects on a nursing infant. Consult your doctor||
0108|156|P|before breastfeeding.||
0108|157|B|||
0108|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0108|159|I|medications work or increase your risk for serious side effects.||
0108|160|I|This document does not contain all possible drug interactions.||
0108|161|I|Keep a list of all the products you use (including||
0108|162|I|prescription/nonprescription drugs and herbal products) and share||
0108|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
0108|164|I|the dosage of any medicines without your doctor's approval.||
0108|165|I|   Some products that may interact with this drug are:||
0108|166|I|febuxostat, past or present use of certain cancer drugs (such as||
0108|167|I|cyclophosphamide, melphalan), other drugs that weaken the immune||
0108|168|I|system/increase the risk of infection (such as rituximab,||
0108|169|I|tofacitinib).||
0108|170|I|   Azathioprine is very similar to mercaptopurine. Do not use||
0108|171|I|medications containing mercaptopurine while using azathioprine.||
0108|172|B|||
0108|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0108|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0108|175|O|poison control center right away. US residents can call||
0108|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0108|177|B|||
0108|178|N|NOTES:  Do not share this medication with others.||
0108|179|N|   Lab and/or medical tests (such as complete blood count,||
0108|180|N|liver/kidney function) should be done while you are taking this||
0108|181|N|medication. Keep all medical and lab appointments. Consult your||
0108|182|N|doctor for more details.||
0108|183|N|   If you have had an organ transplant, attend a transplant||
0108|184|N|education class or support group. Learn the symptoms of organ||
0108|185|N|rejection such as a feeling of being ill, fever, pain around the||
0108|186|N|transplanted organ, and the signs of a failing transplanted organ||
0108|187|N|(a decrease in the amount of urine with kidney transplant). Get||
0108|188|N|medical help right away if these symptoms occur.||
0108|189|B|||
0108|190|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0108|191|D|remember. If it is near the time of the next dose, skip the||
0108|192|D|missed dose. Take your next dose at the regular time. Do not||
0108|193|D|double the dose to catch up.||
0108|194|B|||
0108|195|R|STORAGE:  Store at room temperature away from light and moisture.||
0108|196|R|Do not store in the bathroom. Keep all medications away from||
0108|197|R|children and pets.||
0108|198|R|   Do not flush medications down the toilet or pour them into a||
0108|199|R|drain unless instructed to do so. Properly discard this product||
0108|200|R|when it is expired or no longer needed. Consult your pharmacist||
0108|201|R|or local waste disposal company.||
0108|202|B|||
0108|203|M|MEDICAL ALERT:  Your condition can cause complications in a||
0108|204|M|medical emergency. For information about enrolling in MedicAlert,||
0108|205|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0108|206|B|||
0108|207|A|Information last revised May 2024.||
0108|208|A|Copyright(c) 2025 First Databank, Inc.||
0108|209|B|||
0109|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0109|002|Z|does NOT have all possible information about this product. This||
0109|003|Z|information does not assure that this product is safe, effective,||
0109|004|Z|or appropriate for you. This information is not individual||
0109|005|Z|medical advice and does not substitute for the advice of your||
0109|006|Z|health care professional. Always ask your health care||
0109|007|Z|professional for complete information about this product and your||
0109|008|Z|specific health needs.||
0109|009|B|||
0109|010|T|BISACODYL - ORAL||
0109|011|F|(bis-AK-oh-dil)||
0109|012|B|||
0109|013|C|COMMON BRAND NAME(S): Dulcolax||
0109|014|B|||
0109|015|U|USES:  Bisacodyl is used to treat constipation. It may also be||
0109|016|U|used to clean out the intestines before a bowel||
0109|017|U|examination/surgery. Bisacodyl is known as a stimulant laxative.||
0109|018|U|It works by increasing the movement of the intestines, helping||
0109|019|U|the stool to come out.||
0109|020|B|||
0109|021|H|HOW TO USE:  Take this medication by mouth as directed by your||
0109|022|H|doctor. If you are self-treating, follow all directions on the||
0109|023|H|product package. If you have any questions, ask your doctor or||
0109|024|H|pharmacist.||
0109|025|H|   Swallow this medication whole. Do not crush, chew, or break||
0109|026|H|the tablet or take it within 1 hour of antacids, milk, or milk||
0109|027|H|products. Doing so can destroy the coating on the tablet and may||
0109|028|H|increase the risk of stomach upset and nausea.||
0109|029|H|   Dosage is based on your age, medical condition, and response||
0109|030|H|to treatment. Do not increase your dose or take this drug more||
0109|031|H|often than directed. Do not take this medication for more than 7||
0109|032|H|days unless directed by your doctor. Serious side effects may||
0109|033|H|occur with overuse of this medication (see also Side Effects||
0109|034|H|section).||
0109|035|H|   It may take 6 to 12 hours before this medication causes a||
0109|036|H|bowel movement. Tell your doctor if your condition lasts or gets||
0109|037|H|worse, or if bleeding from the rectum occurs. If you think you||
0109|038|H|may have a serious medical problem, get medical help right away.||
0109|039|B|||
0109|040|S|SIDE EFFECTS:  Stomach/abdominal pain or cramping, nausea,||
0109|041|S|diarrhea, or weakness may occur. If any of these effects last or||
0109|042|S|get worse, tell your doctor or pharmacist promptly.||
0109|043|S|   If your doctor has directed you to use this medication,||
0109|044|S|remember that your doctor has judged that the benefit to you is||
0109|045|S|greater than the risk of side effects. Many people using this||
0109|046|S|medication do not have serious side effects.||
0109|047|S|   Tell your doctor right away if you have any serious side||
0109|048|S|effects, including: nausea/vomiting/diarrhea that doesn't stop,||
0109|049|S|muscle cramps/weakness, irregular heartbeat, dizziness, fainting,||
0109|050|S|decreased urination, mental/mood changes (such as confusion).||
0109|051|S|   A very serious allergic reaction to this drug is rare.||
0109|052|S|However, get medical help right away if you notice any symptoms||
0109|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0109|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0109|055|S|breathing.||
0109|056|S|   This is not a complete list of possible side effects. If you||
0109|057|S|notice other effects not listed above, contact your doctor or||
0109|058|S|pharmacist.||
0109|059|S|   In the US -||
0109|060|S|   Call your doctor for medical advice about side effects. You||
0109|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0109|062|S|www.fda.gov/medwatch.||
0109|063|S|   In Canada - Call your doctor for medical advice about side||
0109|064|S|effects. You may report side effects to Health Canada at||
0109|065|S|1-866-234-2345.||
0109|066|B|||
0109|067|P|PRECAUTIONS:  Before taking bisacodyl, tell your doctor or||
0109|068|P|pharmacist if you are allergic to it; or if you have any other||
0109|069|P|allergies. This product may contain inactive ingredients, which||
0109|070|P|can cause allergic reactions or other problems. Talk to your||
0109|071|P|pharmacist for more details.||
0109|072|P|   Before using this medication, tell your doctor or pharmacist||
0109|073|P|your medical history, especially of: appendicitis or symptoms of||
0109|074|P|appendicitis (such as nausea/vomiting, sudden or unexplained||
0109|075|P|stomach/abdominal pain), a sudden change in bowel habits that||
0109|076|P|lasts for longer than 2 weeks, bleeding from the rectum,||
0109|077|P|intestinal blockage.||
0109|078|P|   Before having surgery, tell your doctor or dentist about all||
0109|079|P|the products you use (including prescription drugs,||
0109|080|P|nonprescription drugs, and herbal products).||
0109|081|P|   Tell your doctor if you are pregnant before using this||
0109|082|P|medication. Using it for long periods during pregnancy is not||
0109|083|P|recommended. Consult your doctor for more details.||
0109|084|P|   It is unknown if this medication passes into breast milk.||
0109|085|P|Consult your doctor before breastfeeding.||
0109|086|B|||
0109|087|I|DRUG INTERACTIONS:  See also How To Use section.||
0109|088|I|   Drug interactions may change how your medications work or||
0109|089|I|increase your risk for serious side effects. This document does||
0109|090|I|not contain all possible drug interactions. Keep a list of all||
0109|091|I|the products you use (including prescription/nonprescription||
0109|092|I|drugs and herbal products) and share it with your doctor and||
0109|093|I|pharmacist. Do not start, stop, or change the dosage of any||
0109|094|I|medicines without your doctor's approval.||
0109|095|I|   Some products that may interact with this drug are:||
0109|096|I|medications that decrease stomach acid (such as H2 blockers like||
0109|097|I|ranitidine, proton pump inhibitors like omeprazole).||
0109|098|B|||
0109|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0109|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0109|101|O|poison control center right away. US residents can call||
0109|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0109|103|O|Symptoms of overdose may include: nausea/vomiting/diarrhea that||
0109|104|O|doesn't stop, severe stomach/abdominal pain or cramping.||
0109|105|B|||
0109|106|N|NOTES:  Keep all medical and lab appointments.||
0109|107|N|   Lifestyle changes that may prevent or relieve constipation||
0109|108|N|include exercising, drinking enough water, and eating a proper||
0109|109|N|diet with fiber-rich foods such as bran, fresh fruits/vegetables.||
0109|110|N|Talk to your doctor or pharmacist about lifestyle changes that||
0109|111|N|might benefit you.||
0109|112|B|||
0109|113|D|MISSED DOSE:  If your doctor has directed you to take this||
0109|114|D|medication on a regular schedule and you miss a dose, take it as||
0109|115|D|soon as you remember. If it is near the time of the next dose,||
0109|116|D|skip the missed dose. Take your next dose at the regular time. Do||
0109|117|D|not double the dose to catch up.||
0109|118|B|||
0109|119|R|STORAGE:  Different brands of this medication have different||
0109|120|R|storage needs. Check the product package for instructions on how||
0109|121|R|to store your brand, or ask your pharmacist. Keep all medications||
0109|122|R|away from children and pets.||
0109|123|R|   Do not flush medications down the toilet or pour them into a||
0109|124|R|drain unless instructed to do so. Properly discard this product||
0109|125|R|when it is expired or no longer needed. Consult your pharmacist||
0109|126|R|or local waste disposal company.||
0109|127|B|||
0109|128|A|Information last revised May 2024.||
0109|129|A|Copyright(c) 2025 First Databank, Inc.||
0109|130|B|||
0110|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0110|002|Z|does NOT have all possible information about this product. This||
0110|003|Z|information does not assure that this product is safe, effective,||
0110|004|Z|or appropriate for you. This information is not individual||
0110|005|Z|medical advice and does not substitute for the advice of your||
0110|006|Z|health care professional. Always ask your health care||
0110|007|Z|professional for complete information about this product and your||
0110|008|Z|specific health needs.||
0110|009|B|||
0110|010|T|CHLORAL HYDRATE - ORAL||
0110|011|F|(KLOR-al HYE-drate)||
0110|012|B|||
0110|013|C|COMMON BRAND NAME(S): Noctec||
0110|014|B|||
0110|015|U|USES:  This medication is used to calm you just before surgery or||
0110|016|U|other procedures. It belongs to a class of drugs known as||
0110|017|U|hypnotics. It works by affecting certain parts of the brain to||
0110|018|U|cause calmness.||
0110|019|B|||
0110|020|H|HOW TO USE:  Take this medication by mouth with or without food||
0110|021|H|as directed by your doctor, usually 30 minutes before your||
0110|022|H|surgery/procedure. Follow your doctor's directions for how much||
0110|023|H|liquid or food you can have before your procedure.||
0110|024|H|   If you are using the liquid form of this medication, carefully||
0110|025|H|measure the dose using a special measuring device/spoon. Do not||
0110|026|H|use a household spoon because you may not get the correct dose.||
0110|027|H|Mix your dose with a full glass of water or other liquid (such as||
0110|028|H|fruit juice, ginger ale) before taking it.||
0110|029|H|   The dosage is based on your medical condition and response to||
0110|030|H|treatment. Children's dosage is also based on weight.||
0110|031|H|   Though it helps many people, this medication may sometimes||
0110|032|H|cause addiction. This risk may be higher if you have a substance||
0110|033|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0110|034|H|Do not increase your dose, take it more often, or use it for a||
0110|035|H|longer time than prescribed. Properly stop the medication when so||
0110|036|H|directed.||
0110|037|H|   If you suddenly stop using this medication, you may have||
0110|038|H|withdrawal symptoms (such as sweating, trembling, anxiety,||
0110|039|H|confusion, seizures, and hallucinations). Withdrawal from chloral||
0110|040|H|hydrate can be severe (rarely fatal). To help prevent withdrawal,||
0110|041|H|your doctor may lower your dose slowly. Withdrawal is more likely||
0110|042|H|if you have used chloral hydrate for a long time or in high||
0110|043|H|doses. Tell your doctor or pharmacist right away if you have||
0110|044|H|withdrawal.||
0110|045|H|   When this medication is used for a long time, it may not work||
0110|046|H|as well. Talk with your doctor if this medication stops working||
0110|047|H|well.||
0110|048|B|||
0110|049|S|SIDE EFFECTS:  Drowsiness and trouble waking up in the morning,||
0110|050|S|nausea, vomiting, stomach pain, diarrhea, and headache may occur.||
0110|051|S|Stomach problems can be reduced by taking chloral hydrate with a||
0110|052|S|full glass of water. If any of these effects last or get worse,||
0110|053|S|tell your doctor or pharmacist promptly.||
0110|054|S|   Remember that this medication has been prescribed because your||
0110|055|S|doctor has judged that the benefit to you is greater than the||
0110|056|S|risk of side effects. Many people using this medication do not||
0110|057|S|have serious side effects.||
0110|058|S|   Tell your doctor right away if you have any serious side||
0110|059|S|effects, including: mental/mood changes (such as confusion,||
0110|060|S|thinking that others wish to harm you), sleep-walking, staggering||
0110|061|S|walk/loss of balance, severe dizziness, fainting.||
0110|062|S|   Long-term use may cause serious stomach problems (gastritis)||
0110|063|S|or kidney problems. Tell your doctor right away if any of these||
0110|064|S|serious side effects occur: vomit that looks like coffee grounds,||
0110|065|S|difficult/painful swallowing, black/tarry stools, severe||
0110|066|S|stomach/abdominal pain, change in the amount of urine.||
0110|067|S|   Get medical help right away if you have any very serious side||
0110|068|S|effects, including: slow/shallow breathing.||
0110|069|S|   A very serious allergic reaction to this drug is rare.||
0110|070|S|However, get medical help right away if you notice any symptoms||
0110|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0110|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0110|073|S|breathing.||
0110|074|S|   This is not a complete list of possible side effects. If you||
0110|075|S|notice other effects not listed above, contact your doctor or||
0110|076|S|pharmacist.||
0110|077|S|   In the US -||
0110|078|S|   Call your doctor for medical advice about side effects. You||
0110|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0110|080|S|www.fda.gov/medwatch.||
0110|081|S|   In Canada - Call your doctor for medical advice about side||
0110|082|S|effects. You may report side effects to Health Canada at||
0110|083|S|1-866-234-2345.||
0110|084|B|||
0110|085|P|PRECAUTIONS:  Before taking chloral hydrate, tell your doctor or||
0110|086|P|pharmacist if you are allergic to it; or if you have any other||
0110|087|P|allergies. This product may contain inactive ingredients, which||
0110|088|P|can cause allergic reactions or other problems. Talk to your||
0110|089|P|pharmacist for more details.||
0110|090|P|   Before using this medication, tell your doctor or pharmacist||
0110|091|P|your medical history, especially of: personal or family history||
0110|092|P|of a substance use disorder (such as overuse of or addiction to||
0110|093|P|drugs/alcohol), heart problems, kidney problems, liver problems,||
0110|094|P|mental/mood conditions (such as depression, thoughts of suicide),||
0110|095|P|irritation of the swallowing tube (esophagus), stomach problems||
0110|096|P|(such as ulcer, gastritis), a certain blood/liver disease||
0110|097|P|(porphyria), breathing problems (such as sleep apnea).||
0110|098|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
0110|099|P|can make you more drowsy. Do not drive, use machinery, or do||
0110|100|P|anything that needs alertness until you can do it safely. Avoid||
0110|101|P|alcoholic beverages. Very severe side effects from use with||
0110|102|P|alcohol may include inability to wake up and slowed breathing.||
0110|103|P|Drinking alcohol may also result in severe stomach upset/cramps,||
0110|104|P|nausea, vomiting, headache, or flushing. Talk to your doctor if||
0110|105|P|you are using marijuana (cannabis).||
0110|106|P|   Before having surgery, tell your doctor or dentist about all||
0110|107|P|the products you use (including prescription drugs,||
0110|108|P|nonprescription drugs, and herbal products).||
0110|109|P|   Older adults may be more sensitive to the side effects of this||
0110|110|P|drug, especially drowsiness and confusion. These side effects can||
0110|111|P|increase the risk of falling.||
0110|112|P|   During pregnancy, this medication should be used only when||
0110|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
0110|114|P|   This drug passes into breast milk and may have undesirable||
0110|115|P|effects on a nursing infant. Consult your doctor before||
0110|116|P|breastfeeding.||
0110|117|B|||
0110|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0110|119|I|medications work or increase your risk for serious side effects.||
0110|120|I|This document does not contain all possible drug interactions.||
0110|121|I|Keep a list of all the products you use (such as||
0110|122|I|prescription/nonprescription drugs and herbal products) and share||
0110|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
0110|124|I|the dosage of any medicines without your doctor's approval.||
0110|125|I|   Some products that may interact with this drug include: "blood||
0110|126|I|thinners" (such as warfarin).||
0110|127|I|   The risk of serious side effects (such as slow/shallow||
0110|128|I|breathing, severe drowsiness/dizziness) may be increased if this||
0110|129|I|medication is taken with other products that may also cause||
0110|130|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0110|131|I|if you are taking other products such as opioid pain or cough||
0110|132|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0110|133|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0110|134|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0110|135|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0110|136|I|diphenhydramine).||
0110|137|I|   Check the labels on all your medicines (such as allergy or||
0110|138|I|cough-and-cold products) because they may contain ingredients||
0110|139|I|that cause drowsiness. Ask your pharmacist about using those||
0110|140|I|products safely.||
0110|141|I|   This medication may interfere with certain lab tests (such as||
0110|142|I|certain urine tests for sugar, catecholamines,||
0110|143|I|17-hydroxycorticosteroids), possibly causing false test results.||
0110|144|I|Make sure lab personnel and all your doctors know you use this||
0110|145|I|drug.||
0110|146|B|||
0110|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0110|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0110|149|O|poison control center right away. US residents can call||
0110|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0110|151|O|Symptoms of overdose may include: irregular heartbeat, fainting,||
0110|152|O|inability to wake up, slowed breathing, bluish/cold skin.||
0110|153|B|||
0110|154|N|NOTES:  Do not share this medication with others. Sharing it is||
0110|155|N|against the law.||
0110|156|B|||
0110|157|D|MISSED DOSE:  Not applicable.||
0110|158|B|||
0110|159|R|STORAGE:  Store at room temperature away from light and moisture.||
0110|160|R|Do not store in the bathroom. Keep all medications away from||
0110|161|R|children and pets.||
0110|162|R|   Do not flush medications down the toilet or pour them into a||
0110|163|R|drain unless instructed to do so. Properly discard this product||
0110|164|R|when it is expired or no longer needed. Consult your pharmacist||
0110|165|R|or local waste disposal company.||
0110|166|B|||
0110|167|A|Information last revised September 2024.||
0110|168|A|Copyright(c) 2025 First Databank, Inc.||
0110|169|B|||
0111|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0111|002|Z|does NOT have all possible information about this product. This||
0111|003|Z|information does not assure that this product is safe, effective,||
0111|004|Z|or appropriate for you. This information is not individual||
0111|005|Z|medical advice and does not substitute for the advice of your||
0111|006|Z|health care professional. Always ask your health care||
0111|007|Z|professional for complete information about this product and your||
0111|008|Z|specific health needs.||
0111|009|B|||
0111|010|T|COLESTIPOL GRANULES - ORAL||
0111|011|F|(koe-LES-ti-pol)||
0111|012|B|||
0111|013|C|COMMON BRAND NAME(S): Colestid||
0111|014|B|||
0111|015|U|USES:  Colestipol is used along with a proper diet to lower||
0111|016|U|cholesterol in the blood. Lowering cholesterol helps decrease the||
0111|017|U|risk for strokes and heart attacks.||
0111|018|U|   In addition to a proper diet (such as a||
0111|019|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
0111|020|U|help this medication work better include exercising, losing||
0111|021|U|weight if overweight, and stopping smoking. Consult your doctor||
0111|022|U|for more details.||
0111|023|U|   This medication is known as a bile acid-binding resin. It||
0111|024|U|works by removing bile acid from the body. In people with high||
0111|025|U|cholesterol, this causes the liver to make more bile acid by||
0111|026|U|using cholesterol in the blood. This helps to lower the||
0111|027|U|cholesterol levels.||
0111|028|B|||
0111|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
0111|030|H|doctor, usually 1 to 2 times a day. This medication comes as||
0111|031|H|granules with doses measured by the scoopful (using the provided||
0111|032|H|scoop) or in individual dose packets. Do not take your dose in||
0111|033|H|the dry powder form. Mix the medication in at least 3 ounces (90||
0111|034|H|milliliters) of liquid (such as water, milk, fruit juice), stir||
0111|035|H|completely, and drink right away. Rinse your glass with more||
0111|036|H|liquid and drink the rinse liquid to be sure that you have taken||
0111|037|H|the entire dose. You may also mix this medication with watery||
0111|038|H|soups, applesauce, or a pulpy fruit which has a lot of juice||
0111|039|H|(such as crushed pineapple, peaches).||
0111|040|H|   The dosage is based on your medical condition and response to||
0111|041|H|treatment. To reduce your risk of side effects, your doctor may||
0111|042|H|direct you to start this medication at a low dose and gradually||
0111|043|H|increase your dose. Follow your doctor's instructions carefully.||
0111|044|H|It may take several weeks before you get the full benefit of this||
0111|045|H|drug.||
0111|046|H|   Colestipol may decrease your absorption of other medications.||
0111|047|H|Take your other medications as directed by your doctor, usually||
0111|048|H|at least 1 hour before or 4 to 6 hours after colestipol. Ask your||
0111|049|H|doctor or pharmacist for more information or if you have any||
0111|050|H|questions.||
0111|051|H|   Take this medication regularly in order to get the most||
0111|052|H|benefit from it. To help you remember, take it at the same||
0111|053|H|time(s) each day. Keep taking this medication even if you feel||
0111|054|H|well. Most people with high cholesterol do not feel sick.||
0111|055|B|||
0111|056|S|SIDE EFFECTS:  Constipation, stomach/abdominal pain, gas, nausea,||
0111|057|S|and vomiting may occur. If any of these effects last or get||
0111|058|S|worse, tell your doctor or pharmacist promptly.||
0111|059|S|   To prevent constipation, eat dietary fiber, drink enough||
0111|060|S|water, and exercise. You may also need to take a laxative. Ask||
0111|061|S|your pharmacist which type of laxative is right for you.||
0111|062|S|   Remember that this medication has been prescribed because your||
0111|063|S|doctor has judged that the benefit to you is greater than the||
0111|064|S|risk of side effects. Many people using this medication do not||
0111|065|S|have serious side effects.||
0111|066|S|   Tell your doctor right away if you have any serious side||
0111|067|S|effects, including: severe stomach/abdominal pain, unusual||
0111|068|S|bleeding/bruising, rapid breathing, confusion.||
0111|069|S|   A very serious allergic reaction to this drug is rare.||
0111|070|S|However, get medical help right away if you notice any symptoms||
0111|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0111|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0111|073|S|breathing.||
0111|074|S|   This is not a complete list of possible side effects. If you||
0111|075|S|notice other effects not listed above, contact your doctor or||
0111|076|S|pharmacist.||
0111|077|S|   In the US -||
0111|078|S|   Call your doctor for medical advice about side effects. You||
0111|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0111|080|S|www.fda.gov/medwatch.||
0111|081|S|   In Canada - Call your doctor for medical advice about side||
0111|082|S|effects. You may report side effects to Health Canada at||
0111|083|S|1-866-234-2345.||
0111|084|B|||
0111|085|P|PRECAUTIONS:  Before taking colestipol, tell your doctor or||
0111|086|P|pharmacist if you are allergic to it; or if you have any other||
0111|087|P|allergies. This product may contain inactive ingredients, which||
0111|088|P|can cause allergic reactions or other problems. Talk to your||
0111|089|P|pharmacist for more details.||
0111|090|P|   Before using this medication, tell your doctor or pharmacist||
0111|091|P|your medical history, especially of: constipation, hemorrhoids,||
0111|092|P|kidney disease.||
0111|093|P|   The flavored colestipol granules contain aspartame. If you||
0111|094|P|have phenylketonuria (PKU) or any other condition that requires||
0111|095|P|you to restrict your intake of aspartame (or phenylalanine),||
0111|096|P|consult your doctor or pharmacist about using the flavored||
0111|097|P|granules safely.||
0111|098|P|   Because this drug can interfere with the absorption of certain||
0111|099|P|nutrients (such as folic acid, fat-soluble vitamins including A,||
0111|100|P|D, E, K), your doctor may direct you to take a multivitamin||
0111|101|P|supplement. Consult your doctor for more information.||
0111|102|P|   Before having surgery, tell your doctor or dentist about all||
0111|103|P|the products you use (including prescription drugs,||
0111|104|P|nonprescription drugs, and herbal products).||
0111|105|P|   Older adults may be more sensitive to the side effects of this||
0111|106|P|drug, especially constipation.||
0111|107|P|   During pregnancy, this medication should be used only when||
0111|108|P|clearly needed. It may affect the absorption of certain||
0111|109|P|nutrients. Discuss the risks and benefits with your doctor.||
0111|110|P|   This medication is unlikely to pass into breast milk. However,||
0111|111|P|it may affect the absorption of certain nutrients. Consult your||
0111|112|P|doctor before breastfeeding.||
0111|113|B|||
0111|114|I|DRUG INTERACTIONS:  See also How to Use section.||
0111|115|I|   Drug interactions may change how your medications work or||
0111|116|I|increase your risk for serious side effects. This document does||
0111|117|I|not contain all possible drug interactions. Keep a list of all||
0111|118|I|the products you use (including prescription/nonprescription||
0111|119|I|drugs and herbal products) and share it with your doctor and||
0111|120|I|pharmacist. Do not start, stop, or change the dosage of any||
0111|121|I|medicines without your doctor's approval.||
0111|122|I|   Some products that may interact with this drug include: "blood||
0111|123|I|thinners" (such as warfarin), mycophenolate, raloxifene.||
0111|124|B|||
0111|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0111|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0111|127|O|poison control center right away. US residents can call||
0111|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0111|129|O|Symptoms of overdose may include: severe stomach/abdominal pain.||
0111|130|B|||
0111|131|N|NOTES:  Do not share this medication with others.||
0111|132|N|   Lab and/or medical tests (such as blood||
0111|133|N|cholesterol/triglyceride levels, vitamin levels) should be done||
0111|134|N|while you are taking this medication. Keep all medical and lab||
0111|135|N|appointments. Consult your doctor for more details.||
0111|136|B|||
0111|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0111|138|D|remember. If it is near the time of the next dose, skip the||
0111|139|D|missed dose. Take your next dose at the regular time. Do not||
0111|140|D|double the dose to catch up.||
0111|141|B|||
0111|142|R|STORAGE:  Store at room temperature away from light and moisture.||
0111|143|R|Do not store in the bathroom. Keep all medications away from||
0111|144|R|children and pets.||
0111|145|R|   Do not flush medications down the toilet or pour them into a||
0111|146|R|drain unless instructed to do so. Properly discard this product||
0111|147|R|when it is expired or no longer needed. Consult your pharmacist||
0111|148|R|or local waste disposal company.||
0111|149|B|||
0111|150|A|Information last revised May 2024.||
0111|151|A|Copyright(c) 2025 First Databank, Inc.||
0111|152|B|||
0113|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0113|002|Z|does NOT have all possible information about this product. This||
0113|003|Z|information does not assure that this product is safe, effective,||
0113|004|Z|or appropriate for you. This information is not individual||
0113|005|Z|medical advice and does not substitute for the advice of your||
0113|006|Z|health care professional. Always ask your health care||
0113|007|Z|professional for complete information about this product and your||
0113|008|Z|specific health needs.||
0113|009|B|||
0113|010|T|DICYCLOMINE - ORAL||
0113|011|F|(dye-SYE-kloe-meen)||
0113|012|B|||
0113|013|C|COMMON BRAND NAME(S): Bentyl||
0113|014|B|||
0113|015|U|USES:  Dicyclomine is used to treat a certain type of intestinal||
0113|016|U|problem called irritable bowel syndrome. It helps to reduce the||
0113|017|U|symptoms of stomach and intestinal cramping. This medication||
0113|018|U|works by slowing the natural movements of the gut and by relaxing||
0113|019|U|the muscles in the stomach and intestines. Dicyclomine belongs to||
0113|020|U|a class of drugs known as anticholinergics/antispasmodics.||
0113|021|U|   This medication must not be used by children younger than 6||
0113|022|U|months because of the risk of serious side effects.||
0113|023|B|||
0113|024|H|HOW TO USE:  Take this medication by mouth with or without food||
0113|025|H|as directed by your doctor, usually 4 times a day. To reduce your||
0113|026|H|risk of side effects, your doctor may direct you to start this||
0113|027|H|medication at a low dose and gradually increase your dose. Follow||
0113|028|H|your doctor's instructions carefully.||
0113|029|H|   If you are using the liquid form of this medication, carefully||
0113|030|H|measure the dose using a special measuring device/spoon. Do not||
0113|031|H|use a household spoon because you may not get the correct dose.||
0113|032|H|Mix the dose of liquid with an equal amount of water before||
0113|033|H|taking it.||
0113|034|H|   Antacids lower the absorption of dicyclomine. Do not take this||
0113|035|H|medication at the same time as antacids. If you are taking an||
0113|036|H|antacid, take it after meals and take dicyclomine before meals.||
0113|037|H|   The dosage is based on your age, medical condition, and||
0113|038|H|response to treatment.||
0113|039|H|   Do not increase your dose or take this drug more often without||
0113|040|H|your doctor's approval. Your condition will not improve any||
0113|041|H|faster and the risk of serious side effects may increase.||
0113|042|H|   Tell your doctor if your condition lasts or gets worse.||
0113|043|B|||
0113|044|S|SIDE EFFECTS:  Dizziness, drowsiness, lightheadedness, weakness,||
0113|045|S|blurred vision, dry eyes, dry mouth, nausea, constipation, and||
0113|046|S|abdominal bloating may occur. If any of these effects last or get||
0113|047|S|worse, tell your doctor or pharmacist promptly.||
0113|048|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0113|049|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0113|050|S|substitute. To relieve dry eyes, consult your pharmacist for||
0113|051|S|artificial tears or other eye lubricants.||
0113|052|S|   To prevent constipation, eat dietary fiber, drink enough||
0113|053|S|water, and exercise. You may also need to take a laxative. Ask||
0113|054|S|your pharmacist which type of laxative is right for you.||
0113|055|S|   Remember that this medication has been prescribed because your||
0113|056|S|doctor has judged that the benefit to you is greater than the||
0113|057|S|risk of side effects. Many people using this medication do not||
0113|058|S|have serious side effects.||
0113|059|S|   Tell your doctor right away if you have any serious side||
0113|060|S|effects, including: decreased sweating, dry/hot/flushed skin,||
0113|061|S|fast/irregular heartbeat, loss of coordination, trouble speaking,||
0113|062|S|mental/mood changes (such as confusion, hallucinations,||
0113|063|S|agitation, nervousness, unusual excitement), difficulty||
0113|064|S|urinating, decreased sexual ability.||
0113|065|S|   Get medical help right away if you have any very serious side||
0113|066|S|effects, including: eye pain/swelling/redness, vision changes||
0113|067|S|(such as seeing rainbows around lights at night).||
0113|068|S|   A very serious allergic reaction to this drug is rare.||
0113|069|S|However, get medical help right away if you notice any symptoms||
0113|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0113|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0113|072|S|breathing.||
0113|073|S|   This is not a complete list of possible side effects. If you||
0113|074|S|notice other effects not listed above, contact your doctor or||
0113|075|S|pharmacist.||
0113|076|S|   In the US -||
0113|077|S|   Call your doctor for medical advice about side effects. You||
0113|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0113|079|S|www.fda.gov/medwatch.||
0113|080|S|   In Canada - Call your doctor for medical advice about side||
0113|081|S|effects. You may report side effects to Health Canada at||
0113|082|S|1-866-234-2345.||
0113|083|B|||
0113|084|P|PRECAUTIONS:  Before taking dicyclomine, tell your doctor or||
0113|085|P|pharmacist if you are allergic to it; or if you have any other||
0113|086|P|allergies. This product may contain inactive ingredients, which||
0113|087|P|can cause allergic reactions or other problems. Talk to your||
0113|088|P|pharmacist for more details.||
0113|089|P|   Before using this medication, tell your doctor or pharmacist||
0113|090|P|your medical history, especially of: personal or family history||
0113|091|P|of glaucoma (angle-closure type), difficulty urinating (such as||
0113|092|P|due to an enlarged prostate), other stomach/intestinal problems||
0113|093|P|(such as slow gut, blockage, ulcerative colitis, infection,||
0113|094|P|little/no stomach acid, ileostomy/colostomy patients with||
0113|095|P|diarrhea), overactive thyroid, heart problems (such as coronary||
0113|096|P|artery disease, angina, heart failure, fast/irregular heartbeat,||
0113|097|P|heart problems due to severe bleeding), high blood pressure,||
0113|098|P|heartburn problems (such as acid reflux, hiatal hernia, esophagus||
0113|099|P|problems), certain nervous system problem (autonomic neuropathy),||
0113|100|P|personal or family history of a substance use disorder (such as||
0113|101|P|overuse of or addiction to drugs/alcohol), myasthenia gravis,||
0113|102|P|liver problems, kidney problems.||
0113|103|P|   This drug may make you dizzy or drowsy or blur your vision.||
0113|104|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0113|105|P|drowsy. Do not drive, use machinery, or do anything that needs||
0113|106|P|alertness or clear vision until you can do it safely. Limit||
0113|107|P|alcoholic beverages. Talk to your doctor if you are using||
0113|108|P|marijuana (cannabis).||
0113|109|P|   This medication may make you sweat less, making you more||
0113|110|P|likely to get heat stroke. Avoid doing things that may cause you||
0113|111|P|to overheat, such as hard work or exercise in hot weather, or||
0113|112|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0113|113|P|and dress lightly. If you overheat, quickly look for a place to||
0113|114|P|cool down and rest. Get medical help right away if you have a||
0113|115|P|fever that does not go away, mental/mood changes, headache, or||
0113|116|P|dizziness.||
0113|117|P|   Before having surgery, tell your doctor or dentist about all||
0113|118|P|the products you use (including prescription drugs,||
0113|119|P|nonprescription drugs, and herbal products).||
0113|120|P|   Older adults may be more sensitive to the side effects of this||
0113|121|P|drug, especially drowsiness, confusion, unusual excitement,||
0113|122|P|constipation, fast heartbeat, and urination problems. Drowsiness||
0113|123|P|and confusion can increase the risk of falling.||
0113|124|P|   During pregnancy, this medication should be used only when||
0113|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
0113|126|P|   This medication passes into breast milk and may have||
0113|127|P|undesirable effects on a nursing infant. Breastfeeding is not||
0113|128|P|recommended while using this medication. Consult your doctor for||
0113|129|P|more details.||
0113|130|B|||
0113|131|I|DRUG INTERACTIONS:  See also the How to Use section.||
0113|132|I|   Drug interactions may change how your medications work or||
0113|133|I|increase your risk for serious side effects. This document does||
0113|134|I|not contain all possible drug interactions. Keep a list of all||
0113|135|I|the products you use (including prescription/nonprescription||
0113|136|I|drugs and herbal products) and share it with your doctor and||
0113|137|I|pharmacist. Do not start, stop, or change the dosage of any||
0113|138|I|medicines without your doctor's approval.||
0113|139|I|   Some products that may interact with this drug include:||
0113|140|I|potassium tablets/capsules, drugs that are affected by slowed gut||
0113|141|I|movement (such as pramlintide).||
0113|142|I|   Dicyclomine may affect the absorption of other products such||
0113|143|I|as levodopa, certain azole anti-fungal drugs (ketoconazole,||
0113|144|I|itraconazole), slowly-dissolving forms of digoxin, among others.||
0113|145|I|If you are taking either ketoconazole or itraconazole, take it at||
0113|146|I|least 2 hours before dicyclomine.||
0113|147|I|   Tell your doctor or pharmacist if you are taking other||
0113|148|I|products that cause drowsiness including alcohol, marijuana||
0113|149|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0113|150|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0113|151|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0113|152|I|codeine).||
0113|153|I|   Check the labels on all your medicines (such as allergy or||
0113|154|I|cough-and-cold products, diet aids) because they may contain||
0113|155|I|ingredients that cause drowsiness or a fast heartbeat. Ask your||
0113|156|I|pharmacist about using those products safely.||
0113|157|I|   This medication may interfere with certain lab tests (such as||
0113|158|I|gastric secretion tests), possibly causing false test results.||
0113|159|I|Make sure lab personnel and all your doctors know you use this||
0113|160|I|drug.||
0113|161|B|||
0113|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0113|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0113|164|O|poison control center right away. US residents can call||
0113|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0113|166|O|Symptoms of overdose may include: large pupils, hot/dry skin,||
0113|167|O|fever, severe dizziness, severe thirst, difficulty swallowing,||
0113|168|O|mental/mood changes (such as confusion, unusual excitement),||
0113|169|O|fast/irregular heartbeat, muscle weakness, inability to move||
0113|170|O|(paralysis), slowed breathing, fainting, seizures.||
0113|171|B|||
0113|172|N|NOTES:  Do not share this medication with others.||
0113|173|N|   Management of digestive disorders may include lifestyle||
0113|174|N|changes such as stress reduction programs, exercise, stopping||
0113|175|N|smoking, and dietary changes, in addition to medication. Talk to||
0113|176|N|your doctor or pharmacist about lifestyle changes that might||
0113|177|N|benefit you.||
0113|178|B|||
0113|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0113|180|D|remember. If it is near the time of the next dose, skip the||
0113|181|D|missed dose. Take your next dose at the regular time. Do not||
0113|182|D|double the dose to catch up.||
0113|183|B|||
0113|184|R|STORAGE:  Store at room temperature away from light and moisture.||
0113|185|R|Do not store in the bathroom. Keep all medications away from||
0113|186|R|children and pets.||
0113|187|R|   Do not flush medications down the toilet or pour them into a||
0113|188|R|drain unless instructed to do so. Properly discard this product||
0113|189|R|when it is expired or no longer needed. Consult your pharmacist||
0113|190|R|or local waste disposal company.||
0113|191|B|||
0113|192|A|Information last revised May 2024.||
0113|193|A|Copyright(c) 2025 First Databank, Inc.||
0113|194|B|||
0114|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0114|002|Z|does NOT have all possible information about this product. This||
0114|003|Z|information does not assure that this product is safe, effective,||
0114|004|Z|or appropriate for you. This information is not individual||
0114|005|Z|medical advice and does not substitute for the advice of your||
0114|006|Z|health care professional. Always ask your health care||
0114|007|Z|professional for complete information about this product and your||
0114|008|Z|specific health needs.||
0114|009|B|||
0114|010|T|DISULFIRAM - ORAL||
0114|011|F|(dye-SUL-fi-ram)||
0114|012|B|||
0114|013|C|COMMON BRAND NAME(S): Antabuse||
0114|014|B|||
0114|015|W|WARNING:  This medication should not be given to a patient||
0114|016|W|without their knowledge. Do not take this medication if you are||
0114|017|W|under the influence of alcohol or have drunk alcohol in the last||
0114|018|W|12 hours.||
0114|019|B|||
0114|020|U|USES:  This medication is used along with counseling and support||
0114|021|U|to treat alcoholism. Disulfiram works by blocking the processing||
0114|022|U|of alcohol in the body. This causes you to have a bad reaction||
0114|023|U|when you drink alcohol.||
0114|024|B|||
0114|025|H|HOW TO USE:  See also Precautions section.||
0114|026|H|   Take this medication by mouth with or without food as directed||
0114|027|H|by your doctor, usually once daily in the morning. If this||
0114|028|H|medication causes drowsiness, take it at bedtime. The dosage is||
0114|029|H|based on your medical condition and response to treatment.||
0114|030|H|   Use this medication regularly to get the most benefit from it.||
0114|031|H|To help you remember, take it at the same time each day.||
0114|032|H|   This medication may increase and/or prolong the effects of||
0114|033|H|caffeine. Avoid drinking large amounts of beverages containing||
0114|034|H|caffeine (coffee, tea, colas), eating large amounts of chocolate,||
0114|035|H|or taking nonprescription products that contain caffeine.||
0114|036|B|||
0114|037|S|SIDE EFFECTS:  Drowsiness, tiredness, headache, acne, and||
0114|038|S|metallic/garlic-like taste in the mouth may occur as your body||
0114|039|S|gets used to the medication. If any of these effects last or get||
0114|040|S|worse, tell your doctor or pharmacist promptly.||
0114|041|S|   Remember that this medication has been prescribed because your||
0114|042|S|doctor has judged that the benefit to you is greater than the||
0114|043|S|risk of side effects. Many people using this medication do not||
0114|044|S|have serious side effects.||
0114|045|S|   Tell your doctor right away if you have any serious side||
0114|046|S|effects, including: decreased sexual ability, vision changes,||
0114|047|S|numbness/tingling of arms/legs, muscle weakness, mental/mood||
0114|048|S|changes (such as agitation, confusion), seizures.||
0114|049|S|   This drug may rarely cause serious (rarely fatal) liver||
0114|050|S|disease. If you notice any of the following serious side effects,||
0114|051|S|tell your doctor right away: nausea/vomiting that doesn't stop,||
0114|052|S|stomach/abdominal pain, dark urine, yellowing eyes/skin.||
0114|053|S|   A very serious allergic reaction to this drug is rare.||
0114|054|S|However, get medical help right away if you notice any symptoms||
0114|055|S|of a serious allergic reaction, including: rash, itching/swelling||
0114|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0114|057|S|breathing.||
0114|058|S|   This is not a complete list of possible side effects. If you||
0114|059|S|notice other effects not listed above, contact your doctor or||
0114|060|S|pharmacist.||
0114|061|S|   In the US -||
0114|062|S|   Call your doctor for medical advice about side effects. You||
0114|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0114|064|S|www.fda.gov/medwatch.||
0114|065|S|   In Canada - Call your doctor for medical advice about side||
0114|066|S|effects. You may report side effects to Health Canada at||
0114|067|S|1-866-234-2345.||
0114|068|B|||
0114|069|P|PRECAUTIONS:  Before taking disulfiram, tell your doctor or||
0114|070|P|pharmacist if you are allergic to it; or to thiuram or||
0114|071|P|thiuram-related chemicals (found in pesticides and rubber); or if||
0114|072|P|you have any other allergies. This product may contain inactive||
0114|073|P|ingredients, which can cause allergic reactions or other||
0114|074|P|problems. Talk to your pharmacist for more details.||
0114|075|P|   Before using this medication, tell your doctor or pharmacist||
0114|076|P|your medical history, especially of: heart/blood vessel disease||
0114|077|P|(such as coronary artery disease), mental/mood disorders,||
0114|078|P|diabetes, underactive thyroid (hypothyroidism), brain disorders||
0114|079|P|(such as seizures, brain damage), kidney disease, liver disease,||
0114|080|P|personal or family history of regular use/abuse of drugs.||
0114|081|P|   Avoid all alcoholic beverages or alcohol-containing||
0114|082|P|products/foods (such as cough and cold syrups, mouthwash,||
0114|083|P|aftershave, sauces, vinegars) while taking this medication and||
0114|084|P|for 2 weeks after stopping the medication. Check all product||
0114|085|P|labels carefully to make sure that there is no alcohol in the||
0114|086|P|product. Using alcohol, even a small amount, while taking this||
0114|087|P|medication can lead to a reaction that may include flushing,||
0114|088|P|throbbing headache, breathing problems (such as shortness of||
0114|089|P|breath, fast breathing), nausea, vomiting, dizziness, extreme||
0114|090|P|tiredness, fainting, fast/irregular heartbeat, or blurred vision.||
0114|091|P|These symptoms can last from 30 minutes to several hours. Tell||
0114|092|P|your doctor right away if these symptoms occur, especially if||
0114|093|P|they last or get worse.||
0114|094|P|   A more serious reaction with this medication and alcohol may||
0114|095|P|include trouble breathing, seizures, loss of consciousness,||
0114|096|P|chest/jaw/left arm pain. Get medical help right away if you have||
0114|097|P|these symptoms.||
0114|098|P|   During pregnancy, this medication should be used only when||
0114|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
0114|100|P|   It is unknown if this drug passes into breast milk. Consult||
0114|101|P|your doctor before breastfeeding.||
0114|102|B|||
0114|103|I|DRUG INTERACTIONS:  See also How to Use section.||
0114|104|I|   Drug interactions may change how your medications work or||
0114|105|I|increase your risk for serious side effects. This document does||
0114|106|I|not contain all possible drug interactions. Keep a list of all||
0114|107|I|the products you use (including prescription/nonprescription||
0114|108|I|drugs and herbal products) and share it with your doctor and||
0114|109|I|pharmacist. Do not start, stop, or change the dosage of any||
0114|110|I|medicines without your doctor's approval.||
0114|111|I|   Some products that may interact with this drug are:||
0114|112|I|alcohol-containing products (such as cough and cold syrups,||
0114|113|I|aftershave), amitriptyline, benznidazole, "blood thinners" (such||
0114|114|I|as warfarin), certain medications for seizures (including||
0114|115|I|hydantoins such as phenytoin/fosphenytoin), fezolinetant,||
0114|116|I|isoniazid, metronidazole, theophylline, tinidazole.||
0114|117|I|   This medication may interfere with certain lab tests (such as||
0114|118|I|urine VMA/HVA tests), possibly causing false test results. Make||
0114|119|I|sure lab personnel and all your doctors know you use this drug.||
0114|120|B|||
0114|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0114|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0114|123|O|poison control center right away. US residents can call||
0114|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0114|125|O|Symptoms of overdose may include: vomiting, drowsiness, loss of||
0114|126|O|coordination, loss of consciousness.||
0114|127|B|||
0114|128|N|NOTES:  Do not share this medication with others.||
0114|129|N|   Lab and/or medical tests (such as liver function, complete||
0114|130|N|blood count) should be done while you are taking this medication.||
0114|131|N|Keep all medical and lab appointments. Consult your doctor for||
0114|132|N|more details.||
0114|133|N|   It is recommended that you carry an identification card||
0114|134|N|stating that you are taking this medication and describing the||
0114|135|N|possible reaction that may occur if you consume alcohol.||
0114|136|B|||
0114|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0114|138|D|remember. If it is near the time of the next dose, skip the||
0114|139|D|missed dose. Take your next dose at the regular time. Do not||
0114|140|D|double the dose to catch up.||
0114|141|B|||
0114|142|R|STORAGE:  Store at room temperature away from light and moisture.||
0114|143|R|Do not store in the bathroom. Keep all medications away from||
0114|144|R|children and pets.||
0114|145|R|   Do not flush medications down the toilet or pour them into a||
0114|146|R|drain unless instructed to do so. Properly discard this product||
0114|147|R|when it is expired or no longer needed. Consult your pharmacist||
0114|148|R|or local waste disposal company.||
0114|149|B|||
0114|150|A|Information last revised July 2025.||
0114|151|A|Copyright(c) 2025 First Databank, Inc.||
0114|152|B|||
0115|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0115|002|Z|does NOT have all possible information about this product. This||
0115|003|Z|information does not assure that this product is safe, effective,||
0115|004|Z|or appropriate for you. This information is not individual||
0115|005|Z|medical advice and does not substitute for the advice of your||
0115|006|Z|health care professional. Always ask your health care||
0115|007|Z|professional for complete information about this product and your||
0115|008|Z|specific health needs.||
0115|009|B|||
0115|010|T|PROGESTIN/ESTROGEN CONTRACEPTIVE - ORAL||
0115|011|F|(proe-JES-tin/ES-troe-jen)||
0115|012|B|||
0115|013|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
0115|014|W|tobacco and are over 35 years old. Smoking raises your risk of||
0115|015|W|stroke, heart attack, blood clots, and high blood pressure from||
0115|016|W|hormonal birth control (such as the pill, patch, ring). The risk||
0115|017|W|of these serious problems increases with age and with the number||
0115|018|W|of cigarettes you smoke. Do not smoke or use tobacco.||
0115|019|B|||
0115|020|U|USES:  This combination hormone medication is used to prevent||
0115|021|U|pregnancy. It contains 2 hormones: a progestin and an estrogen.||
0115|022|U|   Besides preventing pregnancy, birth control pills may make||
0115|023|U|your periods more regular, decrease blood loss and painful||
0115|024|U|periods, decrease your risk of ovarian cysts, and also treat||
0115|025|U|acne.||
0115|026|U|   This medication does not protect against sexually transmitted||
0115|027|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
0115|028|U|an effective barrier method (latex or polyurethane condom/dental||
0115|029|U|dams) during sexual activity will help to decrease your risk of||
0115|030|U|infection.||
0115|031|B|||
0115|032|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0115|033|H|your pharmacist before you start using this product and each time||
0115|034|H|you get a refill. The leaflet contains very important information||
0115|035|H|on when to take your pills and what to do if you miss a dose. If||
0115|036|H|you have any questions, ask your doctor or pharmacist.||
0115|037|H|   Take this medication by mouth as directed by your doctor,||
0115|038|H|usually once daily. Pick a time of day that is easy for you to||
0115|039|H|remember, and take your pill at the same time each day.||
0115|040|H|   If you are taking the chewable tablet, you may either swallow||
0115|041|H|it whole or chew it thoroughly and swallow. If you are taking the||
0115|042|H|rapidly-dissolving tablet, you may either dissolve it on your||
0115|043|H|tongue and then swallow with a full glass of water (8 ounces/240||
0115|044|H|milliliters), or swallow the tablet whole with a full glass of||
0115|045|H|water (8 ounces/240 milliliters). Carefully follow the||
0115|046|H|manufacturer's directions for your brand.||
0115|047|H|   It is very important to keep taking this medication exactly as||
0115|048|H|prescribed by your doctor. With certain brands of birth control||
0115|049|H|pills, the amount of estrogen and progestin in each active tablet||
0115|050|H|will vary at different times in the cycle. It is very important||
0115|051|H|that you follow the package instructions to find the first||
0115|052|H|tablet, start with the first tablet in the pack, and take them in||
0115|053|H|the correct order. Do not skip any doses. Pregnancy is more||
0115|054|H|likely if you miss pills, start a new pack late, or take your||
0115|055|H|pill at a different time of the day than usual.||
0115|056|H|   Vomiting or diarrhea can prevent your birth control pills from||
0115|057|H|working well. If you have vomiting or diarrhea, you may need to||
0115|058|H|use a backup birth control method (such as condoms, spermicide).||
0115|059|H|Follow the directions in the Patient Information Leaflet and||
0115|060|H|check with your doctor or pharmacist for more details.||
0115|061|H|   Taking this medication after your evening meal or at bedtime||
0115|062|H|may help if you have stomach upset or nausea with the medication.||
0115|063|H|You may choose to take this medication at another time of day||
0115|064|H|that is easier for you to remember. No matter what dosing||
0115|065|H|schedule you use, it is very important that you take this||
0115|066|H|medication at the same time each day, 24 hours apart. Ask your||
0115|067|H|doctor or pharmacist if you have any questions.||
0115|068|H|   Your pill pack contains 21 pills with active medication. It||
0115|069|H|may also contain 7 reminder pills with no medication. Take one||
0115|070|H|active pill (with hormones) once daily for 21 days in a row. If||
0115|071|H|you are using a product with 28 tablets, take an inactive pill||
0115|072|H|once daily for 7 days in a row after you have taken the last||
0115|073|H|active pill unless otherwise directed by your doctor. If you are||
0115|074|H|using a product with 21 tablets, do not take any tablets for 7||
0115|075|H|days unless otherwise directed by your doctor. You should have||
0115|076|H|your period during the fourth week of the cycle. After you have||
0115|077|H|taken the last inactive tablet in the pack or gone 7 days without||
0115|078|H|taking an active tablet, start a new pack the next day whether or||
0115|079|H|not you have your period. If you do not get your period, consult||
0115|080|H|your doctor.||
0115|081|H|   If this is the first time you are using this medication and||
0115|082|H|you are not switching from another form of hormonal birth control||
0115|083|H|(such as patch, other birth control pills), take the first tablet||
0115|084|H|in the pack on the first Sunday following the beginning of your||
0115|085|H|menstrual period or on the first day of your period. If your||
0115|086|H|period begins on a Sunday, begin taking this medication on that||
0115|087|H|day. For the first cycle of use only, use a backup form of||
0115|088|H|non-hormonal birth control (such as condoms, spermicide) for the||
0115|089|H|first 7 days to prevent pregnancy until the medication has enough||
0115|090|H|time to work. If you start on the first day of your period, you||
0115|091|H|do not need to use backup birth control the first week.||
0115|092|H|   Ask your doctor or pharmacist about how to switch from other||
0115|093|H|forms of hormonal birth control (such as patch, other birth||
0115|094|H|control pills) to this product. If any information is unclear,||
0115|095|H|consult the Patient Information Leaflet or your doctor or||
0115|096|H|pharmacist.||
0115|097|B|||
0115|098|S|SIDE EFFECTS:  Nausea, vomiting, headache, bloating, breast||
0115|099|S|tenderness, swelling of the ankles/feet (fluid retention), or||
0115|100|S|weight change may occur. Vaginal bleeding between periods||
0115|101|S|(spotting) or missed/irregular periods may occur, especially||
0115|102|S|during the first few months of use. If any of these effects last||
0115|103|S|or get worse, tell your doctor or pharmacist promptly. If you||
0115|104|S|miss 2 periods in a row (or 1 period if the pill has not been||
0115|105|S|used properly), contact your doctor for a pregnancy test.||
0115|106|S|   Remember that this medication has been prescribed because your||
0115|107|S|doctor has judged that the benefit to you is greater than the||
0115|108|S|risk of side effects. Many people using this medication do not||
0115|109|S|have serious side effects.||
0115|110|S|   This medication may raise your blood pressure. Check your||
0115|111|S|blood pressure regularly and tell your doctor if the results are||
0115|112|S|high.||
0115|113|S|   Tell your doctor right away if you have any serious side||
0115|114|S|effects, including: lumps in the breast, mental/mood changes||
0115|115|S|(such as new/worsening depression), severe stomach/abdominal||
0115|116|S|pain, unusual changes in vaginal bleeding (such as continuous||
0115|117|S|spotting, sudden heavy bleeding, missed periods), dark urine,||
0115|118|S|yellowing eyes/skin.||
0115|119|S|   This medication may rarely cause serious (sometimes fatal)||
0115|120|S|problems from blood clots (such as heart attack, stroke, blood||
0115|121|S|clots in the lungs or legs). Get medical help right away if you||
0115|122|S|have: chest/jaw/left arm pain, confusion, sudden||
0115|123|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0115|124|S|trouble speaking, shortness of breath/rapid breathing,||
0115|125|S|sudden/severe headaches, unusual sweating, weakness on one side||
0115|126|S|of the body, sudden vision changes.||
0115|127|S|   A very serious allergic reaction to this drug is rare.||
0115|128|S|However, get medical help right away if you notice any symptoms||
0115|129|S|of a serious allergic reaction, including: rash, itching/swelling||
0115|130|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0115|131|S|breathing.||
0115|132|S|   This is not a complete list of possible side effects. If you||
0115|133|S|notice other effects not listed above, contact your doctor or||
0115|134|S|pharmacist.||
0115|135|S|   In the US -||
0115|136|S|   Call your doctor for medical advice about side effects. You||
0115|137|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0115|138|S|www.fda.gov/medwatch.||
0115|139|S|   In Canada - Call your doctor for medical advice about side||
0115|140|S|effects. You may report side effects to Health Canada at||
0115|141|S|1-866-234-2345.||
0115|142|B|||
0115|143|P|PRECAUTIONS:  See also Warning section.||
0115|144|P|   Before using this medication, tell your doctor or pharmacist||
0115|145|P|if you are allergic to any estrogens (such as ethinyl estradiol,||
0115|146|P|mestranol) or any progestins (such as norethindrone,||
0115|147|P|desogestrel); or if you have any other allergies. This product||
0115|148|P|may contain inactive ingredients, which can cause allergic||
0115|149|P|reactions or other problems. Talk to your pharmacist for more||
0115|150|P|details.||
0115|151|P|   Before using this medication, tell your doctor or pharmacist||
0115|152|P|your medical history, especially of: blood clots (for example, in||
0115|153|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
0115|154|P|C or protein S deficiency), high blood pressure, abnormal breast||
0115|155|P|exam, cancer (especially endometrial or breast cancer), high||
0115|156|P|cholesterol or triglyceride (blood fat) levels, depression,||
0115|157|P|diabetes, family or personal history of a certain swelling||
0115|158|P|disorder (angioedema), gallbladder problems, severe||
0115|159|P|headaches/migraines, heart problems (such as heart valve disease,||
0115|160|P|irregular heartbeat, previous heart attack), history of yellowing||
0115|161|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
0115|162|P|birth control (such as pills, patch), kidney disease, liver||
0115|163|P|disease (including tumors), obesity, stroke, swelling (edema),||
0115|164|P|thyroid problems, unexplained vaginal bleeding.||
0115|165|P|   If you have diabetes, this medication may affect your blood||
0115|166|P|sugar. Check your blood sugar regularly as directed and share the||
0115|167|P|results with your doctor. Tell your doctor right away if you have||
0115|168|P|symptoms of high blood sugar such as increased thirst/urination.||
0115|169|P|Your doctor may need to adjust your diabetes medication, exercise||
0115|170|P|program, or diet.||
0115|171|P|   Chewable tablets may contain sugar and/or aspartame. Caution||
0115|172|P|is advised if you have diabetes, phenylketonuria (PKU), or any||
0115|173|P|other condition that requires you to limit/avoid these substances||
0115|174|P|in your diet.||
0115|175|P|   Tell your doctor if you just had or will be having surgery or||
0115|176|P|if you will be confined to a bed or chair for a long time (such||
0115|177|P|as a long plane flight). These conditions increase your risk of||
0115|178|P|getting blood clots, especially if you are using hormonal birth||
0115|179|P|control. You may need to stop this medication for a time or take||
0115|180|P|special precautions.||
0115|181|P|   Before having surgery, tell your doctor or dentist about all||
0115|182|P|the products you use (including prescription drugs,||
0115|183|P|nonprescription drugs, and herbal products).||
0115|184|P|   This medication may cause blotchy, dark areas on your face and||
0115|185|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0115|186|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0115|187|P|wear protective clothing when outdoors.||
0115|188|P|   If you are nearsighted or wear contact lenses, you may develop||
0115|189|P|vision problems or trouble wearing your contact lenses. Contact||
0115|190|P|your eye doctor if these problems occur.||
0115|191|P|   It may take longer for you to become pregnant after you stop||
0115|192|P|taking birth control pills. Consult your doctor.||
0115|193|P|   This medication should not be used during pregnancy. If you||
0115|194|P|become pregnant or think you may be pregnant, tell your doctor||
0115|195|P|right away. If you have just given birth or had a pregnancy||
0115|196|P|loss/abortion after the first 3 months, talk with your doctor||
0115|197|P|about reliable forms of birth control, and find out when it is||
0115|198|P|safe to start using birth control that contains a form of||
0115|199|P|estrogen, such as this medication.||
0115|200|P|   A small amount of this medication passes into breast milk and||
0115|201|P|may have undesirable effects on a nursing infant. Consult your||
0115|202|P|doctor before breastfeeding.||
0115|203|B|||
0115|204|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0115|205|I|medications work or increase your risk for serious side effects.||
0115|206|I|This document does not contain all possible drug interactions.||
0115|207|I|Keep a list of all the products you use (including||
0115|208|I|prescription/nonprescription drugs and herbal products) and share||
0115|209|I|it with your doctor and pharmacist. Do not start, stop, or change||
0115|210|I|the dosage of any medicines without your doctor's approval.||
0115|211|I|   Some products that may interact with this drug include:||
0115|212|I|aromatase inhibitors (such as anastrozole, exemestane),||
0115|213|I|fezolinetant, ospemifene, tamoxifen, tizanidine, tranexamic acid.||
0115|214|I|   Some drugs may cause hormonal birth control to work less well||
0115|215|I|by decreasing the amount of birth control hormones in your body.||
0115|216|I|This effect can result in pregnancy. Examples include||
0115|217|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
0115|218|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
0115|219|I|seizures (such as barbiturates, carbamazepine, felbamate,||
0115|220|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
0115|221|I|nevirapine), among others.||
0115|222|I|   Tell your doctor when you start any new drug, and discuss if||
0115|223|I|you should use reliable backup birth control. Also tell your||
0115|224|I|doctor if you have any new spotting or breakthrough bleeding,||
0115|225|I|because these may be signs that your birth control is not working||
0115|226|I|well.||
0115|227|I|   This medication may interfere with certain lab tests (such as||
0115|228|I|blood clotting factors, thyroid), possibly causing false test||
0115|229|I|results. Make sure lab personnel and all your doctors know you||
0115|230|I|use this drug.||
0115|231|B|||
0115|232|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0115|233|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0115|234|O|poison control center right away. US residents can call||
0115|235|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0115|236|O|Symptoms of overdose may include severe nausea and vomiting,||
0115|237|O|sudden/unusual vaginal bleeding.||
0115|238|B|||
0115|239|N|NOTES:  Do not share this medication with others.||
0115|240|N|   Regular complete physical exams which include lab and/or||
0115|241|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
0115|242|N|Pap smear) should be done while you are taking this medication.||
0115|243|N|Follow your doctor's instructions for examining your breasts, and||
0115|244|N|report any lumps right away. Keep all medical and lab||
0115|245|N|appointments. Consult your doctor for more details.||
0115|246|B|||
0115|247|D|MISSED DOSE:  Refer to the product package information for advice||
0115|248|D|on missed doses. You may need to use backup birth control (such||
0115|249|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
0115|250|D|pharmacist if you have any questions.||
0115|251|D|   If you often forget to take your pills as directed, contact||
0115|252|D|your doctor to discuss switching to another form of birth||
0115|253|D|control.||
0115|254|B|||
0115|255|R|STORAGE:  Store at room temperature away from light and moisture.||
0115|256|R|Do not store in the bathroom. Keep all medications away from||
0115|257|R|children and pets.||
0115|258|R|   Do not flush medications down the toilet or pour them into a||
0115|259|R|drain unless instructed to do so. Properly discard this product||
0115|260|R|when it is expired or no longer needed. Consult your pharmacist||
0115|261|R|or local waste disposal company.||
0115|262|B|||
0115|263|A|Information last revised October 2025.||
0115|264|A|Copyright(c) 2025 First Databank, Inc.||
0115|265|B|||
0117|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0117|002|Z|does NOT have all possible information about this product. This||
0117|003|Z|information does not assure that this product is safe, effective,||
0117|004|Z|or appropriate for you. This information is not individual||
0117|005|Z|medical advice and does not substitute for the advice of your||
0117|006|Z|health care professional. Always ask your health care||
0117|007|Z|professional for complete information about this product and your||
0117|008|Z|specific health needs.||
0117|009|B|||
0117|010|T|FOLIC ACID - ORAL||
0117|011|F|(FOE-lik AS-id)||
0117|012|B|||
0117|013|U|USES:  Folic acid is the man-made form of folate. Folate is a||
0117|014|U|B-vitamin naturally found in some foods. It is needed to form||
0117|015|U|healthy cells, especially red blood cells.||
0117|016|U|   Folic acid supplements may come in different forms (such as||
0117|017|U|L-methylfolate, levomefolate, methyltetrahydrofolate). They are||
0117|018|U|used to treat or prevent low folate levels. Low folate levels can||
0117|019|U|lead to certain types of anemia. Conditions that can cause low||
0117|020|U|folate levels include poor diet, pregnancy, alcoholism, liver||
0117|021|U|disease, certain stomach/intestinal problems, kidney dialysis,||
0117|022|U|among others. Women of childbearing age should receive adequate||
0117|023|U|amounts of folic acid either through their diet or supplements to||
0117|024|U|prevent infant spinal cord birth defects.||
0117|025|B|||
0117|026|H|HOW TO USE:  Take this product by mouth with or without food as||
0117|027|H|directed by your doctor, usually once daily. If you are taking||
0117|028|H|the over-the-counter product, follow all directions on the||
0117|029|H|product package. If you have any questions, ask your doctor or||
0117|030|H|pharmacist.||
0117|031|H|   Dosage is based on your medical condition and response to||
0117|032|H|treatment. Do not increase your dose or take this product more||
0117|033|H|often than directed.||
0117|034|H|   Take this product regularly to get the most benefit from it.||
0117|035|H|To help you remember, take it at the same time each day. Follow||
0117|036|H|the diet plan recommended by your doctor or dietician. See also||
0117|037|H|Notes section.||
0117|038|H|   If your condition lasts or gets worse, or if you think you may||
0117|039|H|have a serious medical problem, get medical help right away.||
0117|040|B|||
0117|041|S|SIDE EFFECTS:  Folic acid usually has very few side effects. If||
0117|042|S|you have any unusual effects from taking this product, tell your||
0117|043|S|doctor or pharmacist promptly.||
0117|044|S|   If your doctor has directed you to use this product, remember||
0117|045|S|that your doctor has judged that the benefit to you is greater||
0117|046|S|than the risk of side effects. Many people using this product do||
0117|047|S|not have serious side effects.||
0117|048|S|   A very serious allergic reaction to this drug is rare.||
0117|049|S|However, get medical help right away if you notice any symptoms||
0117|050|S|of a serious allergic reaction, including: rash, itching/swelling||
0117|051|S|(especially of the face/tongue/throat), dizziness, trouble||
0117|052|S|breathing.||
0117|053|S|   This is not a complete list of possible side effects. If you||
0117|054|S|notice other effects not listed above, contact your doctor or||
0117|055|S|pharmacist.||
0117|056|S|   In the US -||
0117|057|S|   Call your doctor for medical advice about side effects. You||
0117|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0117|059|S|www.fda.gov/medwatch.||
0117|060|S|   In Canada - Call your doctor for medical advice about side||
0117|061|S|effects. You may report side effects to Health Canada at||
0117|062|S|1-866-234-2345.||
0117|063|B|||
0117|064|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0117|065|P|pharmacist if you are allergic to it; or if you have any other||
0117|066|P|allergies. This product may contain inactive ingredients, which||
0117|067|P|can cause allergic reactions or other problems. Talk to your||
0117|068|P|pharmacist for more details.||
0117|069|P|   Before using this product, tell your doctor or pharmacist your||
0117|070|P|medical history, especially of: vitamin B-12 deficiency||
0117|071|P|(pernicious anemia).||
0117|072|P|   Before having surgery, tell your doctor or dentist about all||
0117|073|P|the products you use (including prescription drugs,||
0117|074|P|nonprescription drugs, and herbal products).||
0117|075|P|   Folic acid is safe to take during pregnancy when used as||
0117|076|P|directed. It is included in prenatal vitamin products. Certain||
0117|077|P|spinal cord birth defects may be prevented by taking adequate||
0117|078|P|amounts of folic acid during pregnancy. Consult your doctor for||
0117|079|P|more details.||
0117|080|P|   Folic acid passes into breast milk but is unlikely to harm a||
0117|081|P|nursing infant. Consult your doctor before breastfeeding.||
0117|082|B|||
0117|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0117|084|I|medications work or increase your risk for serious side effects.||
0117|085|I|This document does not contain all possible drug interactions.||
0117|086|I|Keep a list of all the products you use (including||
0117|087|I|prescription/nonprescription drugs and herbal products) and share||
0117|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
0117|089|I|the dosage of any medicines without your doctor's approval.||
0117|090|B|||
0117|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0117|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0117|093|O|poison control center right away. US residents can call||
0117|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0117|095|O|Symptoms of overdose may include: mental/mood changes.||
0117|096|B|||
0117|097|N|NOTES:  Do not share this medication with others.||
0117|098|N|   Lab and/or medical tests (such as complete blood count, folate||
0117|099|N|blood level, vitamin B-12 blood level) should be done while you||
0117|100|N|are taking this product. Keep all medical and lab appointments.||
0117|101|N|Consult your doctor for more details.||
0117|102|N|   Folate is naturally found in leafy green vegetables, organ||
0117|103|N|meats (liver, kidney), citrus fruits, and other foods. Folic acid||
0117|104|N|is added to enriched grain products such as bread, pasta, and||
0117|105|N|cereal. Consult your doctor or dietician for a diet plan rich in||
0117|106|N|folate/folic acid.||
0117|107|B|||
0117|108|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0117|109|D|remember. If it is near the time of the next dose, skip the||
0117|110|D|missed dose. Take your next dose at the regular time. Do not||
0117|111|D|double the dose to catch up.||
0117|112|B|||
0117|113|R|STORAGE:  Store at room temperature away from light and moisture.||
0117|114|R|Do not store in the bathroom. Keep all medications away from||
0117|115|R|children and pets.||
0117|116|R|   Do not flush medications down the toilet or pour them into a||
0117|117|R|drain unless instructed to do so. Properly discard this product||
0117|118|R|when it is expired or no longer needed. Consult your pharmacist||
0117|119|R|or local waste disposal company.||
0117|120|B|||
0117|121|A|Information last revised May 2024.||
0117|122|A|Copyright(c) 2025 First Databank, Inc.||
0117|123|B|||
0118|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0118|002|Z|does NOT have all possible information about this product. This||
0118|003|Z|information does not assure that this product is safe, effective,||
0118|004|Z|or appropriate for you. This information is not individual||
0118|005|Z|medical advice and does not substitute for the advice of your||
0118|006|Z|health care professional. Always ask your health care||
0118|007|Z|professional for complete information about this product and your||
0118|008|Z|specific health needs.||
0118|009|B|||
0118|010|T|GUAIFENESIN - ORAL||
0118|011|F|(gwye-FEN-e-sin)||
0118|012|B|||
0118|013|C|COMMON BRAND NAME(S): Guiatuss, Robitussin||
0118|014|B|||
0118|015|U|USES:  Guaifenesin is used to treat coughs and congestion caused||
0118|016|U|by the common cold, bronchitis, and other breathing illnesses.||
0118|017|U|This product is usually not used for ongoing cough from smoking||
0118|018|U|or long-term breathing problems (such as chronic bronchitis,||
0118|019|U|emphysema) unless directed by your doctor. Guaifenesin is an||
0118|020|U|expectorant. It works by thinning and loosening mucus in the||
0118|021|U|airways, clearing congestion, and making breathing easier.||
0118|022|U|   If you are self-treating with this medication, it is important||
0118|023|U|to read the package instructions carefully before you start using||
0118|024|U|this product to be sure it is right for you. (See also||
0118|025|U|Precautions section.)||
0118|026|U|   Cough-and-cold products have not been shown to be safe or||
0118|027|U|effective in children younger than 6 years. Do not use this||
0118|028|U|product to treat cold symptoms in children younger than 6 years||
0118|029|U|unless specifically directed by the doctor. Some products (such||
0118|030|U|as long-acting tablets/capsules) are not recommended for use in||
0118|031|U|children younger than 12 years. Ask your doctor or pharmacist for||
0118|032|U|more details about using your product safely.||
0118|033|U|   These products do not cure or shorten the length of the common||
0118|034|U|cold. To decrease the risk for side effects, carefully follow all||
0118|035|U|dosage directions. Do not give other cough-and-cold medication||
0118|036|U|that might contain the same or similar ingredients (see also Drug||
0118|037|U|Interactions section). Ask the doctor or pharmacist about other||
0118|038|U|ways to relieve cough and cold symptoms (such as drinking enough||
0118|039|U|fluids, using a humidifier or saline nose drops/spray).||
0118|040|B|||
0118|041|H|HOW TO USE:  Take this medication by mouth with or without food,||
0118|042|H|as directed by your doctor, usually every 4 hours. If you are||
0118|043|H|self-treating, follow all directions on the product package. If||
0118|044|H|you have any questions, ask your doctor or pharmacist.||
0118|045|H|   Guaifenesin may have a bitter taste. Do not split the tablets||
0118|046|H|unless they have a score line and your doctor or pharmacist tells||
0118|047|H|you to do so. Swallow the whole or split tablet without crushing||
0118|048|H|or chewing.||
0118|049|H|   If you are using the liquid form of this medication, carefully||
0118|050|H|measure the dose using a special measuring device/spoon. Do not||
0118|051|H|use a household spoon because you may not get the correct dose.||
0118|052|H|   For powder packets, empty the entire contents of the packet||
0118|053|H|onto the tongue and swallow. To prevent a bitter taste, do not||
0118|054|H|chew.||
0118|055|H|   Dosage is based on your age, medical condition, and response||
0118|056|H|to treatment. Do not take more than 6 doses in a day. Do not||
0118|057|H|increase your dose or take this drug more often than directed.||
0118|058|H|   Drink plenty of fluids while taking this medication. Fluids||
0118|059|H|will help to break up mucus and clear congestion.||
0118|060|H|   Tell your doctor if your cough is accompanied by a headache||
0118|061|H|that doesn't go away, fever, severe sore throat, rash, or if it||
0118|062|H|lasts, returns, or gets worse after 7 days. These may be signs of||
0118|063|H|a serious medical problem. Get medical help right away if you||
0118|064|H|think you may have a serious medical problem.||
0118|065|B|||
0118|066|S|SIDE EFFECTS:  Nausea or vomiting may occur. If either of these||
0118|067|S|effects last or get worse, tell your doctor or pharmacist||
0118|068|S|promptly.||
0118|069|S|   If your doctor has directed you to use this medication,||
0118|070|S|remember that your doctor has judged that the benefit to you is||
0118|071|S|greater than the risk of side effects. Many people using this||
0118|072|S|medication do not have serious side effects.||
0118|073|S|   A very serious allergic reaction to this drug is rare.||
0118|074|S|However, get medical help right away if you notice any symptoms||
0118|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0118|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0118|077|S|breathing.||
0118|078|S|   This is not a complete list of possible side effects. If you||
0118|079|S|notice other effects not listed above, contact your doctor or||
0118|080|S|pharmacist.||
0118|081|S|   In the US -||
0118|082|S|   Call your doctor for medical advice about side effects. You||
0118|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0118|084|S|www.fda.gov/medwatch.||
0118|085|S|   In Canada - Call your doctor for medical advice about side||
0118|086|S|effects. You may report side effects to Health Canada at||
0118|087|S|1-866-234-2345.||
0118|088|B|||
0118|089|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0118|090|P|pharmacist if you are allergic to it; or if you have any other||
0118|091|P|allergies. This product may contain inactive ingredients, which||
0118|092|P|can cause allergic reactions or other problems. Talk to your||
0118|093|P|pharmacist for more details.||
0118|094|P|   Before using this medication, tell your doctor or pharmacist||
0118|095|P|your medical history, especially of: breathing problems (such as||
0118|096|P|emphysema, chronic bronchitis, asthma, smoker's cough), cough||
0118|097|P|with blood or large amounts of mucus.||
0118|098|P|   Liquid forms of this product may contain sugar and/or alcohol.||
0118|099|P|Caution is advised if you have diabetes, liver disease, or any||
0118|100|P|other condition that requires you to limit/avoid these substances||
0118|101|P|in your diet. Ask your doctor or pharmacist about using this||
0118|102|P|product safely||
0118|103|P|   The liquid forms and powder packets of this medication may||
0118|104|P|contain aspartame. If you have phenylketonuria (PKU) or any other||
0118|105|P|condition that requires you to restrict your intake of aspartame||
0118|106|P|(or phenylalanine), consult your doctor or pharmacist about using||
0118|107|P|this product safely.||
0118|108|P|   Before having surgery, tell your doctor or dentist about all||
0118|109|P|the products you use (including prescription drugs,||
0118|110|P|nonprescription drugs, and herbal products).||
0118|111|P|   During pregnancy, this medication should be used only when||
0118|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
0118|113|P|   It is unknown if guaifenesin passes into breast milk. Consult||
0118|114|P|your doctor before breastfeeding.||
0118|115|B|||
0118|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0118|117|I|medications work or increase your risk for serious side effects.||
0118|118|I|This document does not contain all possible drug interactions.||
0118|119|I|Keep a list of all the products you use (including||
0118|120|I|prescription/nonprescription drugs and herbal products) and share||
0118|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
0118|122|I|the dosage of any medicines without your doctor's approval.||
0118|123|I|   Guaifenesin is available in both prescription and||
0118|124|I|nonprescription products. Check the labels of all your||
0118|125|I|medications to make sure you are not taking more than one product||
0118|126|I|containing guaifenesin.||
0118|127|I|   This medication may interfere with certain lab tests (such as||
0118|128|I|urine levels of certain acids), possibly causing false test||
0118|129|I|results. Make sure lab personnel and all your doctors know you||
0118|130|I|use this drug.||
0118|131|B|||
0118|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0118|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0118|134|O|poison control center right away. US residents can call||
0118|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0118|136|B|||
0118|137|N|NOTES:  If your doctor prescribed this medication, do not share||
0118|138|N|this medication with others.||
0118|139|N|   Keep all medical and lab appointments.||
0118|140|N|   This medication is for temporary use only. Do not take this||
0118|141|N|medication for more than 7 days unless your doctor tells you to||
0118|142|N|do so. Tell your doctor if your condition lasts longer than 7||
0118|143|N|days.||
0118|144|B|||
0118|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0118|146|D|remember. If it is near the time of the next dose, skip the||
0118|147|D|missed dose. Take your next dose at the regular time. Do not||
0118|148|D|double the dose to catch up.||
0118|149|B|||
0118|150|R|STORAGE:  Store at room temperature away from light and moisture.||
0118|151|R|Do not store in the bathroom. Do not freeze liquid forms of this||
0118|152|R|medication. Different brands of this medication have different||
0118|153|R|storage needs. Check the product package for instructions on how||
0118|154|R|to store your brand, or ask your pharmacist. Keep all medications||
0118|155|R|away from children and pets.||
0118|156|R|   Do not flush medications down the toilet or pour them into a||
0118|157|R|drain unless instructed to do so. Properly discard this product||
0118|158|R|when it is expired or no longer needed. Consult your pharmacist||
0118|159|R|or local waste disposal company.||
0118|160|B|||
0118|161|A|Information last revised May 2024.||
0118|162|A|Copyright(c) 2025 First Databank, Inc.||
0118|163|B|||
0119|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0119|002|Z|does NOT have all possible information about this product. This||
0119|003|Z|information does not assure that this product is safe, effective,||
0119|004|Z|or appropriate for you. This information is not individual||
0119|005|Z|medical advice and does not substitute for the advice of your||
0119|006|Z|health care professional. Always ask your health care||
0119|007|Z|professional for complete information about this product and your||
0119|008|Z|specific health needs.||
0119|009|B|||
0119|010|T|PYRANTEL - ORAL||
0119|011|F|(pye-RAN-tel)||
0119|012|B|||
0119|013|U|USES:  This medication is used to treat intestinal worm||
0119|014|U|infections such as pinworm, roundworm, and hookworm. Pyrantel||
0119|015|U|belongs to a class of drugs known as anthelmintics. It works by||
0119|016|U|making the worms unable to move (paralyzed) so that the body can||
0119|017|U|remove them naturally in the stool.||
0119|018|U|   This medication may be used to self-treat pinworm infections.||
0119|019|U|For other types of worm infections (such as roundworm, hookworm),||
0119|020|U|use this product only as directed by your doctor. Do not use this||
0119|021|U|medication in children younger than 2 years unless directed by||
0119|022|U|the doctor.||
0119|023|B|||
0119|024|H|HOW TO USE:  If you are taking the over-the-counter product, read||
0119|025|H|all directions on the product package before taking this||
0119|026|H|medication. This medicine comes with a Patient Information||
0119|027|H|Leaflet. Read it carefully. Be sure you understand how to||
0119|028|H|identify pinworms, understand the symptoms of pinworm infections,||
0119|029|H|and how to prevent becoming infected again. If you have any||
0119|030|H|questions, consult your doctor or pharmacist.||
0119|031|H|   Take this medication by mouth with or without food, usually||
0119|032|H|once as a single dose or as directed by your doctor. This||
0119|033|H|medication may be taken with milk or fruit juice. It is not||
0119|034|H|necessary to take a laxative with this medication.||
0119|035|H|   If you are using the chewable tablets, chew each tablet well||
0119|036|H|and swallow. If you are using the liquid form of this medication,||
0119|037|H|shake the bottle well before each dose. Carefully measure the||
0119|038|H|dose using a special measuring device/spoon. Do not use a||
0119|039|H|household spoon because you may not get the correct dose.||
0119|040|H|   The dosage is based on your weight, type of infection, and||
0119|041|H|response to treatment. Do not take more than a total of 1 gram in||
0119|042|H|a single dose. If you are self-treating for pinworms, take the||
0119|043|H|medication once only. Do not repeat the dose without talking with||
0119|044|H|your doctor first. Depending on the type of worm infection you||
0119|045|H|have, your doctor may direct you to take the medication only once||
0119|046|H|or for several days. Your doctor may also direct you to repeat||
0119|047|H|the dose in 2 weeks.||
0119|048|H|   If you continue to see worms in your stool or if symptoms last||
0119|049|H|or get worse, or if you think you may have a different type of||
0119|050|H|worm infection or a serious medical problem, get medical help||
0119|051|H|right away.||
0119|052|B|||
0119|053|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach/abdominal||
0119|054|S|cramps, headache, drowsiness, dizziness, trouble sleeping, or||
0119|055|S|loss of appetite may occur. If any of these effects last or get||
0119|056|S|worse, tell your doctor or pharmacist promptly.||
0119|057|S|   If your doctor has directed you to use this medication,||
0119|058|S|remember that your doctor has judged that the benefit to you is||
0119|059|S|greater than the risk of side effects. Many people using this||
0119|060|S|medication do not have serious side effects.||
0119|061|S|   A very serious allergic reaction to this drug is rare.||
0119|062|S|However, get medical help right away if you notice any symptoms||
0119|063|S|of a serious allergic reaction, including: rash, itching/swelling||
0119|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0119|065|S|breathing.||
0119|066|S|   This is not a complete list of possible side effects. If you||
0119|067|S|notice other effects not listed above, contact your doctor or||
0119|068|S|pharmacist.||
0119|069|S|   In the US -||
0119|070|S|   Call your doctor for medical advice about side effects. You||
0119|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0119|072|S|www.fda.gov/medwatch.||
0119|073|S|   In Canada - Call your doctor for medical advice about side||
0119|074|S|effects. You may report side effects to Health Canada at||
0119|075|S|1-866-234-2345.||
0119|076|B|||
0119|077|P|PRECAUTIONS:  Before taking pyrantel, tell your doctor or||
0119|078|P|pharmacist if you are allergic to it; or if you have any other||
0119|079|P|allergies. This product may contain inactive ingredients, which||
0119|080|P|can cause allergic reactions or other problems. Talk to your||
0119|081|P|pharmacist for more details.||
0119|082|P|   Before using this medication, tell your doctor or pharmacist||
0119|083|P|your medical history, especially of: liver disease, severe lack||
0119|084|P|of nutrition (malnutrition), anemia.||
0119|085|P|   This drug may rarely make you drowsy or dizzy. Alcohol or||
0119|086|P|marijuana (cannabis) can make you more dizzy or drowsy. Do not||
0119|087|P|drive, use machinery, or do anything that needs alertness until||
0119|088|P|you can do it safely. Limit alcoholic beverages. Talk to your||
0119|089|P|doctor if you are using marijuana (cannabis).||
0119|090|P|   Chewable tablets may contain aspartame. If you are taking the||
0119|091|P|chewable tablets and have phenylketonuria (PKU) or any other||
0119|092|P|condition that requires you to restrict your intake of aspartame||
0119|093|P|(or phenylalanine), consult your doctor or pharmacist about using||
0119|094|P|the chewable tablets safely.||
0119|095|P|   Before having surgery, tell your doctor or dentist about all||
0119|096|P|the products you use (including prescription drugs,||
0119|097|P|nonprescription drugs, and herbal products).||
0119|098|P|   During pregnancy, this medication should be used only when||
0119|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
0119|100|P|   It is unknown if this drug passes into breast milk. Consult||
0119|101|P|your doctor before breastfeeding.||
0119|102|B|||
0119|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0119|104|I|medications work or increase your risk for serious side effects.||
0119|105|I|This document does not contain all possible drug interactions.||
0119|106|I|Keep a list of all the products you use (including||
0119|107|I|prescription/nonprescription drugs and herbal products) and share||
0119|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
0119|109|I|the dosage of any medicines without your doctor's approval.||
0119|110|B|||
0119|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0119|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0119|113|O|poison control center right away. US residents can call||
0119|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0119|115|O|Symptoms of overdose may include: muscle||
0119|116|O|spasms/twitching/weakness, trouble breathing.||
0119|117|B|||
0119|118|N|NOTES:  Some types of worm infections can be easily spread among||
0119|119|N|family members or people living within the same household. It is||
0119|120|N|important for family members to be checked even if they do not||
0119|121|N|have symptoms. To keep from being infected again, everyone in the||
0119|122|N|household may need to be treated. Also, thoroughly clean the home||
0119|123|N|and all clothing, and be very careful with personal hygiene. Wash||
0119|124|N|hands often and keep fingernails trimmed. Consult your doctor or||
0119|125|N|pharmacist for details.||
0119|126|N|   If your doctor has directed you to use this medication, use it||
0119|127|N|for your current condition only. Do not use it later for another||
0119|128|N|infection unless your doctor tells you to.||
0119|129|B|||
0119|130|D|MISSED DOSE:  If your doctor has directed you to use more than||
0119|131|D|one dose and you miss a dose, ask your doctor or pharmacist right||
0119|132|D|away for a new dosing schedule.||
0119|133|B|||
0119|134|R|STORAGE:  Store at room temperature away from light and moisture.||
0119|135|R|Do not store in the bathroom. Keep all medications away from||
0119|136|R|children and pets.||
0119|137|R|   Do not flush medications down the toilet or pour them into a||
0119|138|R|drain unless instructed to do so. Properly discard this product||
0119|139|R|when it is expired or no longer needed. Consult your pharmacist||
0119|140|R|or local waste disposal company.||
0119|141|B|||
0119|142|A|Information last revised May 2024.||
0119|143|A|Copyright(c) 2025 First Databank, Inc.||
0119|144|B|||
0120|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0120|002|Z|does NOT have all possible information about this product. This||
0120|003|Z|information does not assure that this product is safe, effective,||
0120|004|Z|or appropriate for you. This information is not individual||
0120|005|Z|medical advice and does not substitute for the advice of your||
0120|006|Z|health care professional. Always ask your health care||
0120|007|Z|professional for complete information about this product and your||
0120|008|Z|specific health needs.||
0120|009|B|||
0120|010|T|MEDROXYPROGESTERONE - ORAL||
0120|011|F|(med-ROX-ee-proe-JES-ter-one)||
0120|012|B|||
0120|013|C|COMMON BRAND NAME(S): Provera||
0120|014|B|||
0120|015|W|WARNING:  Medroxyprogesterone is sometimes used with another||
0120|016|W|medication (a type of estrogen) as combination hormone||
0120|017|W|replacement therapy (HRT) in women after menopause. Combination||
0120|018|W|HRT can rarely cause very serious side effects such as heart||
0120|019|W|disease (for example, heart attacks), stroke, serious blood clots||
0120|020|W|(possibly in the lungs and legs), dementia, and breast cancer.||
0120|021|W|Some of these risks appear to depend on the length of treatment||
0120|022|W|and other factors. Combination HRT should be used for the||
0120|023|W|shortest possible length of time at the lowest effective dose so||
0120|024|W|you can obtain the benefits and minimize the chance of serious||
0120|025|W|side effects from long-term treatment. Combination HRT should not||
0120|026|W|be used to prevent heart disease or dementia. Discuss the risks||
0120|027|W|and benefits of treatment and your personal health history with||
0120|028|W|your doctor. If you take combination HRT, check with your doctor||
0120|029|W|regularly (for example, every 3-6 months) to see if you still||
0120|030|W|need to take it.||
0120|031|W|   If you use this medication for an extended period, you should||
0120|032|W|have a complete physical exam at regular intervals (for example,||
0120|033|W|once a year) or as directed by your doctor. See also Notes||
0120|034|W|section.||
0120|035|B|||
0120|036|U|USES:  Medroxyprogesterone is a type of hormone (progestin). This||
0120|037|U|medication is similar to the progesterone that your body||
0120|038|U|naturally makes and is given to replace the hormone when your||
0120|039|U|body is not making enough of it. This medication has several||
0120|040|U|uses. In women who are not pregnant and not going through||
0120|041|U|menopause, this medication is used to treat abnormal bleeding||
0120|042|U|from the uterus and to restore normal menstrual periods in women||
0120|043|U|who have stopped having them for several months (amenorrhea).||
0120|044|U|   Medroxyprogesterone is also used as part of combination||
0120|045|U|hormone replacement therapy with estrogens to reduce menopause||
0120|046|U|symptoms (such as hot flashes). Medroxyprogesterone is added to||
0120|047|U|estrogen replacement therapy to reduce the risk of cancer of the||
0120|048|U|uterus.||
0120|049|U|   Some brands of this medication may also be used to treat||
0120|050|U|certain types of cancers (breast cancer, endometrial cancer).||
0120|051|U|   This medication must not be used to test for pregnancy.||
0120|052|B|||
0120|053|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0120|054|H|from your pharmacist before you start using this drug and each||
0120|055|H|time you get a refill. If you have any questions, ask your doctor||
0120|056|H|or pharmacist.||
0120|057|H|   Take this medication by mouth as directed by your doctor.||
0120|058|H|Follow the dosing schedule carefully. Ask your doctor if you have||
0120|059|H|any questions. The dosage is based on your medical condition and||
0120|060|H|response to treatment.||
0120|061|H|   For use in combination hormone replacement therapy with||
0120|062|H|estrogens, take this medication usually once daily for the||
0120|063|H|prescribed number of days each month as directed.||
0120|064|H|   For the treatment of stopped menstrual periods (amenorrhea)||
0120|065|H|and abnormal bleeding from the uterus, take this drug usually||
0120|066|H|once daily for 5 to 10 days during the second half of the planned||
0120|067|H|menstrual cycle or as directed by your doctor. Withdrawal||
0120|068|H|bleeding usually occurs within 3 to 7 days after you stop taking||
0120|069|H|the medication.||
0120|070|H|   Tell your doctor if your condition does not get better or if||
0120|071|H|it gets worse.||
0120|072|B|||
0120|073|S|SIDE EFFECTS:  See also Warning section.||
0120|074|S|   Nausea, bloating, breast tenderness, headache, change in||
0120|075|S|vaginal discharge, mood swings, blurred vision, dizziness,||
0120|076|S|drowsiness, or weight gain/loss may occur. If any of these||
0120|077|S|effects last or get worse, notify your doctor or pharmacist||
0120|078|S|promptly.||
0120|079|S|   Remember that this medication has been prescribed because your||
0120|080|S|doctor has judged that the benefit to you is greater than the||
0120|081|S|risk of side effects. Many people using this medication do not||
0120|082|S|have serious side effects.||
0120|083|S|   Tell your doctor right away if you have any serious side||
0120|084|S|effects, including: unusual vaginal bleeding (such as spotting,||
0120|085|S|breakthrough bleeding), mental/mood changes (such as depression,||
0120|086|S|memory loss), swelling of the hands/feet,||
0120|087|S|frequent/burning/painful urination, breast lumps, dark patches on||
0120|088|S|the skin or face (melasma), yellowing eyes/skin, unusual||
0120|089|S|tiredness.||
0120|090|S|   This medication, especially if used along with an estrogen||
0120|091|S|product, may rarely cause very serious (possibly fatal) problems||
0120|092|S|from blood clots (such as heart attack, stroke, blood clots in||
0120|093|S|the lungs, legs, or eyes). Get medical help right away if you||
0120|094|S|have: chest/jaw/left arm pain, weakness on one side of the body,||
0120|095|S|trouble speaking, sudden vision changes, confusion, sudden/severe||
0120|096|S|headaches, sudden dizziness/fainting, shortness of breath/rapid||
0120|097|S|breathing, pain/swelling/warmth in the groin/calf, unusual||
0120|098|S|sweating.||
0120|099|S|   A very serious allergic reaction to this drug is rare.||
0120|100|S|However, get medical help right away if you notice any symptoms||
0120|101|S|of a serious allergic reaction, including: rash, itching/swelling||
0120|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0120|103|S|breathing.||
0120|104|S|   This is not a complete list of possible side effects. If you||
0120|105|S|notice other effects not listed above, contact your doctor or||
0120|106|S|pharmacist.||
0120|107|S|   In the US -||
0120|108|S|   Call your doctor for medical advice about side effects. You||
0120|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0120|110|S|www.fda.gov/medwatch.||
0120|111|S|   In Canada - Call your doctor for medical advice about side||
0120|112|S|effects. You may report side effects to Health Canada at||
0120|113|S|1-866-234-2345.||
0120|114|B|||
0120|115|P|PRECAUTIONS:  See also Warning section.||
0120|116|P|   Before taking medroxyprogesterone, tell your doctor or||
0120|117|P|pharmacist if you are allergic to it; or if you have any other||
0120|118|P|allergies. Some Canadian brands of this product may contain||
0120|119|P|inactive ingredients (such as soybean), which can cause allergic||
0120|120|P|reactions or other problems. Some people who are allergic to||
0120|121|P|peanuts may also be allergic to soy. Talk to your pharmacist for||
0120|122|P|more details.||
0120|123|P|   Before using this medication, tell your doctor or pharmacist||
0120|124|P|your medical history, especially of: blood clots, bleeding in the||
0120|125|P|brain, liver disease, cancer of the breast or other female||
0120|126|P|organs, vaginal bleeding of unknown cause, a loss of pregnancy||
0120|127|P|with some tissue remaining in the uterus ("missed abortion"),||
0120|128|P|family medical history (especially breast lumps and cancer),||
0120|129|P|kidney disease, obesity, heart disease (such as past heart||
0120|130|P|attacks, coronary artery disease, heart failure), high blood||
0120|131|P|pressure, seizures, migraine headaches, asthma, high blood levels||
0120|132|P|of cholesterol/fats, depression, diabetes, strokes, smoking.||
0120|133|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0120|134|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0120|135|P|machinery, or do anything that needs alertness until you can do||
0120|136|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0120|137|P|are using marijuana (cannabis).||
0120|138|P|   Before having surgery, tell your doctor or dentist about all||
0120|139|P|the products you use (including prescription drugs,||
0120|140|P|nonprescription drugs, and herbal products).||
0120|141|P|   This medication may cause blotchy, dark areas on your face and||
0120|142|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0120|143|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0120|144|P|wear protective clothing when outdoors.||
0120|145|P|   This medication should not be used during pregnancy. If you||
0120|146|P|become pregnant or think you may be pregnant, tell your doctor||
0120|147|P|right away.||
0120|148|P|   This drug passes into breast milk. Consult your doctor before||
0120|149|P|breastfeeding.||
0120|150|B|||
0120|151|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0120|152|I|medications work or increase your risk for serious side effects.||
0120|153|I|This document does not contain all possible drug interactions.||
0120|154|I|Keep a list of all the products you use (including||
0120|155|I|prescription/nonprescription drugs and herbal products) and share||
0120|156|I|it with your doctor and pharmacist. Do not start, stop, or change||
0120|157|I|the dosage of any medicines without your doctor's approval.||
0120|158|I|   A product that may interact with this drug is:||
0120|159|I|aminoglutethimide.||
0120|160|I|   Other medications can affect the removal of||
0120|161|I|medroxyprogesterone from your body, which may affect how||
0120|162|I|medroxyprogesterone works. Examples include rifamycins (such as||
0120|163|I|rifampin), St. John's wort, drugs used to treat seizures (such as||
0120|164|I|carbamazepine, phenobarbital, phenytoin).||
0120|165|I|   This medication may interfere with certain lab tests, possibly||
0120|166|I|causing false test results. Make sure lab personnel and all your||
0120|167|I|doctors know you use this drug.||
0120|168|B|||
0120|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0120|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0120|171|O|poison control center right away. US residents can call||
0120|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0120|173|O|Symptoms of overdose may include severe nausea and vomiting.||
0120|174|B|||
0120|175|N|NOTES:  Do not share this medication with others.||
0120|176|N|   Regular complete physical exams which include lab and/or||
0120|177|N|medical tests (such as blood pressure, breast exam/mammogram,||
0120|178|N|pelvic exam, Pap smear) should be done while you are taking this||
0120|179|N|medication. Follow your doctor's instructions for examining your||
0120|180|N|breasts, and report any lumps right away. Keep all medical and||
0120|181|N|lab appointments. Consult your doctor for more details.||
0120|182|B|||
0120|183|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0120|184|D|remember. If it is near the time of the next dose, skip the||
0120|185|D|missed dose. Take your next dose at the regular time. Do not||
0120|186|D|double the dose to catch up.||
0120|187|B|||
0120|188|R|STORAGE:  Store at room temperature away from light and moisture.||
0120|189|R|Do not store in the bathroom. Keep all medications away from||
0120|190|R|children and pets.||
0120|191|R|   Do not flush medications down the toilet or pour them into a||
0120|192|R|drain unless instructed to do so. Properly discard this product||
0120|193|R|when it is expired or no longer needed. Consult your pharmacist||
0120|194|R|or local waste disposal company.||
0120|195|B|||
0120|196|A|Information last revised October 2024.||
0120|197|A|Copyright(c) 2025 First Databank, Inc.||
0120|198|B|||
0121|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0121|002|Z|does NOT have all possible information about this product. This||
0121|003|Z|information does not assure that this product is safe, effective,||
0121|004|Z|or appropriate for you. This information is not individual||
0121|005|Z|medical advice and does not substitute for the advice of your||
0121|006|Z|health care professional. Always ask your health care||
0121|007|Z|professional for complete information about this product and your||
0121|008|Z|specific health needs.||
0121|009|B|||
0121|010|T|METHENAMINE - ORAL||
0121|011|F|(meth-EN-a-meen)||
0121|012|B|||
0121|013|C|COMMON BRAND NAME(S): Hiprex, Mandelamine, Urex||
0121|014|B|||
0121|015|U|USES:  Methenamine is used to prevent or control returning||
0121|016|U|urinary tract infections caused by certain bacteria. It is not||
0121|017|U|used to treat an active infection. Antibiotics must be used first||
0121|018|U|to treat and cure the infection. Methenamine is a drug that stops||
0121|019|U|the growth of bacteria in urine. This medication also contains an||
0121|020|U|ingredient that helps to make the urine acidic. When the urine is||
0121|021|U|acidic, methenamine turns into formaldehyde to kill the bacteria.||
0121|022|U|   This drug is effective only against bacterial infections in||
0121|023|U|the urinary tract. It will not work for other types of bacterial||
0121|024|U|infections (such as in the blood) or for viral infections (such||
0121|025|U|as the common cold or flu). Unnecessary use or misuse of any||
0121|026|U|antibacterial drug can lead to its decreased effectiveness.||
0121|027|B|||
0121|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
0121|029|H|doctor. The dosage is based on the brand of methenamine you are||
0121|030|H|prescribed, your medical condition, and your response to||
0121|031|H|treatment. Children's dosage is also based on age and weight.||
0121|032|H|   Methenamine works better if your urine is more acidic. Your||
0121|033|H|doctor may test the acidity of your urine (urine pH). If||
0121|034|H|necessary, your doctor may recommend ways to increase urine||
0121|035|H|acidity (such as by taking vitamin C/drinking cranberry juice,||
0121|036|H|limiting foods that decrease acidity/increase alkalinity such as||
0121|037|H|milk products/most fruits, adjusting alkalinizing medications).||
0121|038|H|See also Drug Interactions section. Follow your doctor's||
0121|039|H|instructions.||
0121|040|H|   For the best effect, take this drug at evenly spaced times. To||
0121|041|H|help you remember, take this medication at the same time(s) every||
0121|042|H|day.||
0121|043|H|   Tell your doctor if symptoms of a urinary tract infection||
0121|044|H|return (such as burning/painful/frequent urination).||
0121|045|B|||
0121|046|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, abdominal cramps, and||
0121|047|S|loss of appetite may occur. If any of these effects last or get||
0121|048|S|worse, tell your doctor or pharmacist promptly.||
0121|049|S|   Painful or difficult urination may occur with methenamine,||
0121|050|S|although less often. Report these side effects to your doctor,||
0121|051|S|who may need to lower your dose of methenamine or change your||
0121|052|S|treatment to make your urine less acidic.||
0121|053|S|   Remember that this medication has been prescribed because your||
0121|054|S|doctor has judged that the benefit to you is greater than the||
0121|055|S|risk of side effects. Many people using this medication do not||
0121|056|S|have serious side effects.||
0121|057|S|   Taking higher than recommended doses of methenamine may cause||
0121|058|S|bladder irritation, painful/frequent urination, and bloody/pink||
0121|059|S|urine. Tell your doctor right away if you have any of these||
0121|060|S|symptoms.||
0121|061|S|   Tell your doctor right away if you have any serious side||
0121|062|S|effects, including: mouth sores, unusual headache, ringing in the||
0121|063|S|ears, muscle cramps, swelling of the arms/legs.||
0121|064|S|   A very serious allergic reaction to this drug is rare.||
0121|065|S|However, get medical help right away if you notice any symptoms||
0121|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0121|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0121|068|S|breathing.||
0121|069|S|   This is not a complete list of possible side effects. If you||
0121|070|S|notice other effects not listed above, contact your doctor or||
0121|071|S|pharmacist.||
0121|072|S|   In the US -||
0121|073|S|   Call your doctor for medical advice about side effects. You||
0121|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0121|075|S|www.fda.gov/medwatch.||
0121|076|S|   In Canada - Call your doctor for medical advice about side||
0121|077|S|effects. You may report side effects to Health Canada at||
0121|078|S|1-866-234-2345.||
0121|079|B|||
0121|080|P|PRECAUTIONS:  Before taking methenamine, tell your doctor or||
0121|081|P|pharmacist if you are allergic to it; or to formaldehyde; or if||
0121|082|P|you have any other allergies. This product may contain inactive||
0121|083|P|ingredients, which can cause allergic reactions or other||
0121|084|P|problems. Talk to your pharmacist for more details.||
0121|085|P|   Before using this medication, tell your doctor or pharmacist||
0121|086|P|your medical history, especially of: kidney problems, liver||
0121|087|P|problems, dehydration.||
0121|088|P|   Before having surgery, tell your doctor or dentist about all||
0121|089|P|the products you use (including prescription drugs,||
0121|090|P|nonprescription drugs, and herbal products).||
0121|091|P|   During pregnancy, this medication should be used only when||
0121|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
0121|093|P|   This drug passes into breast milk and the effect on a nursing||
0121|094|P|infant is unknown. Consult your doctor before breastfeeding.||
0121|095|B|||
0121|096|I|DRUG INTERACTIONS:  See also How to Use section.||
0121|097|I|   Drug interactions may change how your medications work or||
0121|098|I|increase your risk for serious side effects. This document does||
0121|099|I|not contain all possible drug interactions. Keep a list of all||
0121|100|I|the products you use (including prescription/nonprescription||
0121|101|I|drugs and herbal products) and share it with your doctor and||
0121|102|I|pharmacist. Do not start, stop, or change the dosage of any||
0121|103|I|medicines without your doctor's approval.||
0121|104|I|   Some products that may interact with this drug include:||
0121|105|I|sulfonamide drugs (including sulfa antibiotics such as||
0121|106|I|sulfamethizole), products that decrease the amount of acid in the||
0121|107|I|urine (urinary alkalinizers such as antacids, sodium bicarbonate,||
0121|108|I|potassium or sodium citrate, carbonic anhydrase inhibitors such||
0121|109|I|as acetazolamide).||
0121|110|I|   This medication may interfere with certain lab tests, possibly||
0121|111|I|causing false test results. Make sure lab personnel and all your||
0121|112|I|doctors know you use this drug.||
0121|113|B|||
0121|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0121|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0121|116|O|poison control center right away. US residents can call||
0121|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0121|118|B|||
0121|119|N|NOTES:  Do not share this medication with others.||
0121|120|N|   Lab and/or medical tests (such as urine tests, liver function)||
0121|121|N|should be done while you are taking this medication. Keep all||
0121|122|N|medical and lab appointments. Consult your doctor for more||
0121|123|N|details.||
0121|124|N|   This medication has been prescribed for your current condition||
0121|125|N|only. Do not use it later for another infection unless your||
0121|126|N|doctor tells you to.||
0121|127|B|||
0121|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0121|129|D|remember. If it is near the time of the next dose, skip the||
0121|130|D|missed dose. Take your next dose at the regular time. Do not||
0121|131|D|double the dose to catch up.||
0121|132|B|||
0121|133|R|STORAGE:  Store at room temperature away from light and moisture.||
0121|134|R|Do not store in the bathroom. Keep all medications away from||
0121|135|R|children and pets.||
0121|136|R|   Do not flush medications down the toilet or pour them into a||
0121|137|R|drain unless instructed to do so. Properly discard this product||
0121|138|R|when it is expired or no longer needed. Consult your pharmacist||
0121|139|R|or local waste disposal company.||
0121|140|B|||
0121|141|A|Information last revised September 2024.||
0121|142|A|Copyright(c) 2025 First Databank, Inc.||
0121|143|B|||
0122|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0122|002|Z|does NOT have all possible information about this product. This||
0122|003|Z|information does not assure that this product is safe, effective,||
0122|004|Z|or appropriate for you. This information is not individual||
0122|005|Z|medical advice and does not substitute for the advice of your||
0122|006|Z|health care professional. Always ask your health care||
0122|007|Z|professional for complete information about this product and your||
0122|008|Z|specific health needs.||
0122|009|B|||
0122|010|T|PROPYLTHIOURACIL - ORAL||
0122|011|F|(PROE-pil-THYE-oh-URE-a-sil)||
0122|012|B|||
0122|013|C|COMMON BRAND NAME(S): Propacil||
0122|014|B|||
0122|015|W|WARNING:  Propylthiouracil has rarely caused very serious||
0122|016|W|(possibly fatal) liver disease, especially during the first 6||
0122|017|W|months of treatment. Stop taking propylthiouracil and tell your||
0122|018|W|doctor right away if you develop symptoms of liver disease,||
0122|019|W|including nausea/vomiting that doesn't stop, severe||
0122|020|W|stomach/abdominal pain, dark urine, yellowing eyes/skin.||
0122|021|B|||
0122|022|U|USES:  Propylthiouracil is used to treat overactive thyroid||
0122|023|U|(hyperthyroidism). It works by stopping the thyroid gland from||
0122|024|U|making too much thyroid hormone.||
0122|025|U|   This medication is not recommended for use in children.||
0122|026|B|||
0122|027|H|HOW TO USE:  Read the Medication Guide provided by your||
0122|028|H|pharmacist before you start taking propylthiouracil and each time||
0122|029|H|you get a refill. If you have any questions, ask your doctor or||
0122|030|H|pharmacist.||
0122|031|H|   Take this medication by mouth with or without food as directed||
0122|032|H|by your doctor, usually 3 times a day (every 8 hours).||
0122|033|H|   Dosage is based on your medical condition and response to||
0122|034|H|treatment.||
0122|035|H|   Take this medication exactly as directed. Do not increase your||
0122|036|H|dose or take it more often than prescribed. Your condition will||
0122|037|H|not improve faster, and your risk of side effects will increase.||
0122|038|H|   Use this medication regularly to get the most benefit from it.||
0122|039|H|To help you remember, take it at the same times each day. Do not||
0122|040|H|stop taking this medication without consulting your doctor.||
0122|041|H|   Tell your doctor if your condition does not get better or if||
0122|042|H|it gets worse.||
0122|043|B|||
0122|044|S|SIDE EFFECTS:  Stomach upset, nausea, vomiting, mild||
0122|045|S|rash/itching, or headache may occur. If any of these effects last||
0122|046|S|or get worse, tell your doctor or pharmacist promptly.||
0122|047|S|   Remember that this medication has been prescribed because your||
0122|048|S|doctor has judged that the benefit to you is greater than the||
0122|049|S|risk of side effects. Many people using this medication do not||
0122|050|S|have serious side effects.||
0122|051|S|   Tell your doctor right away if you have any serious side||
0122|052|S|effects, including: muscle/joint pain, signs of kidney problems||
0122|053|S|(such as change in the amount of urine, bloody/dark urine),||
0122|054|S|coughing up blood, shortness of breath.||
0122|055|S|   This medication may rarely cause very serious blood disorders||
0122|056|S|(such as a low number of red cells, white cells, and platelets),||
0122|057|S|especially during the first few months of treatment. Tell your||
0122|058|S|doctor right away if you develop any of the following symptoms:||
0122|059|S|signs of infection (such as sore throat that doesn't go away,||
0122|060|S|fever, chills), easy bruising/bleeding, unusual tiredness.||
0122|061|S|   A very serious allergic reaction to this drug is rare.||
0122|062|S|However, get medical help right away if you notice any symptoms||
0122|063|S|of a serious allergic reaction, including: rash, itching/swelling||
0122|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0122|065|S|breathing.||
0122|066|S|   This is not a complete list of possible side effects. If you||
0122|067|S|notice other effects not listed above, contact your doctor or||
0122|068|S|pharmacist.||
0122|069|S|   In the US -||
0122|070|S|   Call your doctor for medical advice about side effects. You||
0122|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0122|072|S|www.fda.gov/medwatch.||
0122|073|S|   In Canada - Call your doctor for medical advice about side||
0122|074|S|effects. You may report side effects to Health Canada at||
0122|075|S|1-866-234-2345.||
0122|076|B|||
0122|077|P|PRECAUTIONS:  Before taking propylthiouracil, tell your doctor or||
0122|078|P|pharmacist if you are allergic to it; or if you have any other||
0122|079|P|allergies. This product may contain inactive ingredients, which||
0122|080|P|can cause allergic reactions or other problems. Talk to your||
0122|081|P|pharmacist for more details.||
0122|082|P|   Before using this medication, tell your doctor or pharmacist||
0122|083|P|your medical history, especially of: blood disorders (such as||
0122|084|P|agranulocytosis, thrombocytopenia), liver disease.||
0122|085|P|   Before having surgery, tell your doctor or dentist about all||
0122|086|P|the products you use (including prescription drugs,||
0122|087|P|nonprescription drugs, and herbal products).||
0122|088|P|   This medication should be used only when clearly needed during||
0122|089|P|the first 3 months of pregnancy. It is not recommended for use||
0122|090|P|during the last 6 months of pregnancy. Your doctor may direct you||
0122|091|P|to use another medication during that time. Discuss the risks and||
0122|092|P|benefits with your doctor. If you are planning pregnancy, become||
0122|093|P|pregnant, or think you may be pregnant, contact your doctor right||
0122|094|P|away.||
0122|095|P|   This medication passes into breast milk. Consult your doctor||
0122|096|P|before breastfeeding.||
0122|097|B|||
0122|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0122|099|I|medications work or increase your risk for serious side effects.||
0122|100|I|This document does not contain all possible drug interactions.||
0122|101|I|Keep a list of all the products you use (including||
0122|102|I|prescription/nonprescription drugs and herbal products) and share||
0122|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
0122|104|I|the dosage of any medicines without your doctor's approval.||
0122|105|I|   Some products that may interact with this drug include: "blood||
0122|106|I|thinners" (such as warfarin), digoxin.||
0122|107|B|||
0122|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0122|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0122|110|O|poison control center right away. US residents can call||
0122|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0122|112|B|||
0122|113|N|NOTES:  Do not share this medication with others.||
0122|114|N|   Lab and/or medical tests (such as complete blood counts,||
0122|115|N|liver/thyroid function, prothrombin time) should be done while||
0122|116|N|you are taking this medication. Keep all medical and lab||
0122|117|N|appointments. Consult your doctor for more details.||
0122|118|B|||
0122|119|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0122|120|D|remember. If it is near the time of the next dose, skip the||
0122|121|D|missed dose. Take your next dose at the regular time. Do not||
0122|122|D|double the dose to catch up.||
0122|123|B|||
0122|124|R|STORAGE:  Store at room temperature away from light and moisture.||
0122|125|R|Do not store in the bathroom. Keep all medications away from||
0122|126|R|children and pets.||
0122|127|R|   Do not flush medications down the toilet or pour them into a||
0122|128|R|drain unless instructed to do so. Properly discard this product||
0122|129|R|when it is expired or no longer needed. Consult your pharmacist||
0122|130|R|or local waste disposal company.||
0122|131|B|||
0122|132|A|Information last revised April 2025.||
0122|133|A|Copyright(c) 2025 First Databank, Inc.||
0122|134|B|||
0123|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0123|002|Z|does NOT have all possible information about this product. This||
0123|003|Z|information does not assure that this product is safe, effective,||
0123|004|Z|or appropriate for you. This information is not individual||
0123|005|Z|medical advice and does not substitute for the advice of your||
0123|006|Z|health care professional. Always ask your health care||
0123|007|Z|professional for complete information about this product and your||
0123|008|Z|specific health needs.||
0123|009|B|||
0123|010|T|MAGNESIUM HYDROXIDE - ORAL||
0123|011|F|(mag-NEE-zee-um hye-DROX-ide)||
0123|012|B|||
0123|013|U|USES:  This medication is used for a short time to treat||
0123|014|U|occasional constipation. It is also used to treat symptoms caused||
0123|015|U|by too much stomach acid (such as heartburn, upset stomach, or||
0123|016|U|indigestion). This medication is both a laxative (osmotic-type)||
0123|017|U|and antacid. It works by drawing water into the intestines, an||
0123|018|U|effect that helps to cause movement of the intestines. It also||
0123|019|U|works by lowering the amount of acid in the stomach.||
0123|020|B|||
0123|021|H|HOW TO USE:  Take this product by mouth as directed. For the||
0123|022|H|chewable form, chew thoroughly before swallowing. For the liquid||
0123|023|H|form, shake the bottle well before each dose. Carefully measure||
0123|024|H|the dose using a special measuring device/spoon. Do not use a||
0123|025|H|household spoon because you may not get the correct dose. If you||
0123|026|H|are taking this medication for constipation, drink a full glass||
0123|027|H|of water (8 ounces or 240 milliliters) with each dose. Follow all||
0123|028|H|directions on the product package, or use as directed by your||
0123|029|H|doctor. If you have any questions, ask your doctor or pharmacist.||
0123|030|H|   The dosage is based on your medical condition and response to||
0123|031|H|treatment.||
0123|032|H|   Extended use or overuse of this medication for constipation||
0123|033|H|may result in dependence on laxatives and ongoing constipation.||
0123|034|H|Overuse may also cause diarrhea that doesn't stop, dehydration,||
0123|035|H|and mineral imbalances (such as high magnesium).||
0123|036|H|   Tell your doctor if your condition lasts or gets worse. For||
0123|037|H|constipation problems, it may take 30 minutes to 6 hours to||
0123|038|H|produce a bowel movement. Tell your doctor if this product does||
0123|039|H|not produce a bowel movement, if you need to use this medication||
0123|040|H|or other laxative products regularly for more than 1 week, or if||
0123|041|H|you have rectal bleeding. For stomach acid problems, do not take||
0123|042|H|the maximum dose of this medication for more than 2 weeks unless||
0123|043|H|directed by your doctor. If you think you may have a serious||
0123|044|H|medical problem, get medical help right away.||
0123|045|B|||
0123|046|S|SIDE EFFECTS:  Diarrhea may occur. If this effect lasts or gets||
0123|047|S|worse, tell your doctor or pharmacist promptly.||
0123|048|S|   If your doctor has directed you to use this medication,||
0123|049|S|remember that your doctor has judged that the benefit to you is||
0123|050|S|greater than the risk of side effects. Many people using this||
0123|051|S|medication do not have serious side effects.||
0123|052|S|   Tell your doctor right away if you have any serious side||
0123|053|S|effects, including: symptoms of high magnesium levels (such as||
0123|054|S|muscle weakness, slow/irregular heartbeat, slow/shallow||
0123|055|S|breathing, mental/mood changes such as confusion), symptoms of||
0123|056|S|dehydration (such as decreased urination, dizziness, extreme||
0123|057|S|thirst, very dry mouth), stomach/abdominal pain, bloody stools,||
0123|058|S|rectal bleeding.||
0123|059|S|   A very serious allergic reaction to this drug is rare.||
0123|060|S|However, get medical help right away if you notice any symptoms||
0123|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0123|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0123|063|S|breathing.||
0123|064|S|   This is not a complete list of possible side effects. If you||
0123|065|S|notice other effects not listed above, contact your doctor or||
0123|066|S|pharmacist.||
0123|067|S|   In the US -||
0123|068|S|   Call your doctor for medical advice about side effects. You||
0123|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0123|070|S|www.fda.gov/medwatch.||
0123|071|S|   In Canada - Call your doctor for medical advice about side||
0123|072|S|effects. You may report side effects to Health Canada at||
0123|073|S|1-866-234-2345.||
0123|074|B|||
0123|075|P|PRECAUTIONS:  Before taking magnesium hydroxide, tell your doctor||
0123|076|P|or pharmacist if you are allergic to it; or if you have any other||
0123|077|P|allergies. This product may contain inactive ingredients, which||
0123|078|P|can cause allergic reactions or other problems. Talk to your||
0123|079|P|pharmacist for more details.||
0123|080|P|   Before using this medication, tell your doctor or pharmacist||
0123|081|P|your medical history, especially of: kidney disease, appendicitis||
0123|082|P|or symptoms of appendicitis (such as stomach/abdominal pain,||
0123|083|P|nausea/vomiting), magnesium-restricted diet, sudden change in||
0123|084|P|bowel habits that lasts for longer than 2 weeks.||
0123|085|P|   Before having surgery, tell your doctor or dentist about all||
0123|086|P|the products you use (including prescription drugs,||
0123|087|P|nonprescription drugs, and herbal products).||
0123|088|P|   During pregnancy, this medication should be used only when||
0123|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
0123|090|P|   It is unknown if this drug passes into breast milk. Consult||
0123|091|P|your doctor before breastfeeding.||
0123|092|B|||
0123|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0123|094|I|medications work or increase your risk for serious side effects.||
0123|095|I|This document does not contain all possible drug interactions.||
0123|096|I|Keep a list of all the products you use (including||
0123|097|I|prescription/nonprescription drugs and herbal products) and share||
0123|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
0123|099|I|the dosage of any medicines without your doctor's approval.||
0123|100|I|   Antacids can interfere with the absorption of many other||
0123|101|I|drugs. Be sure to check with your pharmacist before taking||
0123|102|I|antacids with any other medication.||
0123|103|B|||
0123|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0123|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0123|106|O|poison control center right away. US residents can call||
0123|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0123|108|O|Symptoms of overdose may include: diarrhea that is severe or||
0123|109|O|doesn't stop, muscle weakness, mental/mood changes (such as||
0123|110|O|confusion), slow/irregular heartbeat, decreased urination,||
0123|111|O|dizziness.||
0123|112|B|||
0123|113|N|NOTES:  Keep all medical and lab appointments.||
0123|114|N|   Lifestyle changes such as regular exercise and diet changes||
0123|115|N|(including drinking enough water, eating a proper diet with||
0123|116|N|fiber-rich foods such as bran, fresh fruits/vegetables) may||
0123|117|N|prevent or relieve constipation. Lifestyle changes such as stress||
0123|118|N|reduction programs, stopping smoking, limiting alcohol, and diet||
0123|119|N|changes (such as avoiding caffeine/certain spices) may help to||
0123|120|N|reduce heartburn and other stomach acid problems. Talk to your||
0123|121|N|doctor or pharmacist about lifestyle changes that might benefit||
0123|122|N|you.||
0123|123|B|||
0123|124|D|MISSED DOSE:  Not applicable.||
0123|125|B|||
0123|126|R|STORAGE:  Store at room temperature away from light and moisture.||
0123|127|R|Do not store in the bathroom. Keep all medications away from||
0123|128|R|children and pets.||
0123|129|R|   Do not flush medications down the toilet or pour them into a||
0123|130|R|drain unless instructed to do so. Properly discard this product||
0123|131|R|when it is expired or no longer needed. Consult your pharmacist||
0123|132|R|or local waste disposal company.||
0123|133|B|||
0123|134|A|Information last revised October 2025.||
0123|135|A|Copyright(c) 2025 First Databank, Inc.||
0123|136|B|||
0124|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0124|002|Z|does NOT have all possible information about this product. This||
0124|003|Z|information does not assure that this product is safe, effective,||
0124|004|Z|or appropriate for you. This information is not individual||
0124|005|Z|medical advice and does not substitute for the advice of your||
0124|006|Z|health care professional. Always ask your health care||
0124|007|Z|professional for complete information about this product and your||
0124|008|Z|specific health needs.||
0124|009|B|||
0124|010|T|MINOXIDIL - ORAL||
0124|011|F|(mi-NOX-i-dil)||
0124|012|B|||
0124|013|C|COMMON BRAND NAME(S): Loniten||
0124|014|B|||
0124|015|W|WARNING:  Minoxidil may cause serious heart problems or worsen||
0124|016|W|chest pain (angina). This medication is only used when other||
0124|017|W|treatments have not worked well or cannot be taken.||
0124|018|W|   Your doctor should direct you to also take other medications||
0124|019|W|to reduce the side effects of minoxidil. These medications||
0124|020|W|include a "water pill" (diuretic) to prevent the body from||
0124|021|W|holding on to too much water and salt and a heart medication||
0124|022|W|(such as a beta blocker including propranolol) to prevent the||
0124|023|W|heart from working too hard or beating too fast.||
0124|024|W|   Your doctor will follow you closely while you are taking this||
0124|025|W|medication. Keep all regular medical and lab appointments.||
0124|026|B|||
0124|027|U|USES:  Minoxidil is used with other medications to treat high||
0124|028|U|blood pressure (hypertension). Lowering high blood pressure helps||
0124|029|U|prevent strokes, heart attacks, and kidney problems. Minoxidil||
0124|030|U|works by relaxing blood vessels so blood can flow more easily.||
0124|031|B|||
0124|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0124|033|H|from your pharmacist before you start taking this medication and||
0124|034|H|each time you get a refill. If you have any questions, ask your||
0124|035|H|doctor or pharmacist.||
0124|036|H|   Take this medication by mouth with or without food as directed||
0124|037|H|by your doctor, usually once or twice a day.||
0124|038|H|   The dosage is based on your medical condition and response to||
0124|039|H|treatment. Children's dosage is also based on weight. Your doctor||
0124|040|H|may direct you to start this medication at a low dose and||
0124|041|H|gradually increase your dose. Follow your doctor's instructions||
0124|042|H|carefully.||
0124|043|H|   Take this medication and your other blood pressure medications||
0124|044|H|regularly in order to get the most benefit from them. To help you||
0124|045|H|remember, take them at the same time(s) each day. Keep taking||
0124|046|H|your medications even if you feel well. Most people with high||
0124|047|H|blood pressure do not feel sick.||
0124|048|H|   Do not stop taking this medication without consulting your||
0124|049|H|doctor. Some conditions may become worse when this drug is||
0124|050|H|suddenly stopped. Your dose may need to be gradually decreased.||
0124|051|H|   It may take several days to a couple of weeks before you get||
0124|052|H|the full benefit of this drug. Tell your doctor if your condition||
0124|053|H|does not get better or if it gets worse (your blood pressure||
0124|054|H|readings remain high or increase).||
0124|055|B|||
0124|056|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
0124|057|S|body adjusts to the medication. If either of these effects lasts||
0124|058|S|or gets worse, tell your doctor or pharmacist promptly.||
0124|059|S|   Minoxidil may cause increased growth or darkening of fine body||
0124|060|S|hairs. If this bothers you, consult your doctor. When you stop||
0124|061|S|taking the medication, the hair will usually return to normal||
0124|062|S|within 1 to 6 months.||
0124|063|S|   Remember that this medication has been prescribed because your||
0124|064|S|doctor has judged that the benefit to you is greater than the||
0124|065|S|risk of side effects. Many people using this medication do not||
0124|066|S|have serious side effects.||
0124|067|S|   Tell your doctor right away if you have any serious side||
0124|068|S|effects, including: fast heartbeat, symptoms of heart failure||
0124|069|S|(such as shortness of breath, swelling ankles/feet, unusual||
0124|070|S|tiredness, unusual/sudden weight gain), fainting.||
0124|071|S|   Get medical help right away if you have any very serious side||
0124|072|S|effects, including: chest/jaw/left arm pain.||
0124|073|S|   A very serious allergic reaction to this drug is rare.||
0124|074|S|However, get medical help right away if you notice any symptoms||
0124|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0124|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0124|077|S|breathing.||
0124|078|S|   This is not a complete list of possible side effects. If you||
0124|079|S|notice other effects not listed above, contact your doctor or||
0124|080|S|pharmacist.||
0124|081|S|   In the US -||
0124|082|S|   Call your doctor for medical advice about side effects. You||
0124|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0124|084|S|www.fda.gov/medwatch.||
0124|085|S|   In Canada - Call your doctor for medical advice about side||
0124|086|S|effects. You may report side effects to Health Canada at||
0124|087|S|1-866-234-2345.||
0124|088|B|||
0124|089|P|PRECAUTIONS:  Before taking minoxidil, tell your doctor or||
0124|090|P|pharmacist if you are allergic to it; or if you have any other||
0124|091|P|allergies. This product may contain inactive ingredients, which||
0124|092|P|can cause allergic reactions or other problems. Talk to your||
0124|093|P|pharmacist for more details.||
0124|094|P|   Before using this medication, tell your doctor or pharmacist||
0124|095|P|your medical history, especially of: a certain adrenal gland||
0124|096|P|tumor (pheochromocytoma), heart problems (such as heart failure,||
0124|097|P|chest pain, recent heart attack), kidney disease, a certain lung||
0124|098|P|disease (pulmonary hypertension).||
0124|099|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0124|100|P|can make you more dizzy. Do not drive, use machinery, or do||
0124|101|P|anything that needs alertness until you can do it safely. Limit||
0124|102|P|alcoholic beverages. Talk to your doctor if you are using||
0124|103|P|marijuana (cannabis).||
0124|104|P|   Before having surgery, tell your doctor or dentist about all||
0124|105|P|the products you use (including prescription drugs,||
0124|106|P|nonprescription drugs, and herbal products).||
0124|107|P|   During pregnancy, this medication should be used only when||
0124|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
0124|109|P|   This drug passes into breast milk, but is unlikely to harm a||
0124|110|P|nursing infant. Consult your doctor before breastfeeding.||
0124|111|B|||
0124|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0124|113|I|medications work or increase your risk for serious side effects.||
0124|114|I|This document does not contain all possible drug interactions.||
0124|115|I|Keep a list of all the products you use (including||
0124|116|I|prescription/nonprescription drugs and herbal products) and share||
0124|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
0124|118|I|the dosage of any medicines without your doctor's approval.||
0124|119|I|   Some products that may interact with this drug include:||
0124|120|I|guanethidine.||
0124|121|I|   Some products have ingredients that could raise your blood||
0124|122|I|pressure. Tell your pharmacist what products you are using, and||
0124|123|I|ask how to use them safely (especially cough-and-cold products,||
0124|124|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0124|125|B|||
0124|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0124|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0124|128|O|poison control center right away. US residents can call||
0124|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0124|130|O|Symptoms of overdose may include: severe dizziness.||
0124|131|B|||
0124|132|N|NOTES:  Do not share this medication with others.||
0124|133|N|   Lifestyle changes that may help this medication work better||
0124|134|N|include stress reduction programs, exercise, and dietary changes.||
0124|135|N|Talk to your doctor or pharmacist about lifestyle changes that||
0124|136|N|might benefit you.||
0124|137|N|   Lab and/or medical tests (such as blood minerals levels,||
0124|138|N|kidney function, weight) should be done while you are taking this||
0124|139|N|medication. Keep all medical and lab appointments. Consult your||
0124|140|N|doctor for more details.||
0124|141|N|   Have your blood pressure and pulse (heart rate) checked||
0124|142|N|regularly while taking this medication. Learn how to monitor your||
0124|143|N|own blood pressure and pulse at home, and share the results with||
0124|144|N|your doctor.||
0124|145|B|||
0124|146|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0124|147|D|remember. If it is near the time of the next dose, skip the||
0124|148|D|missed dose. Take your next dose at the regular time. Do not||
0124|149|D|double the dose to catch up.||
0124|150|B|||
0124|151|R|STORAGE:  Store at room temperature away from light and moisture.||
0124|152|R|Do not store in the bathroom. Keep all medications away from||
0124|153|R|children and pets.||
0124|154|R|   Do not flush medications down the toilet or pour them into a||
0124|155|R|drain unless instructed to do so. Properly discard this product||
0124|156|R|when it is expired or no longer needed. Consult your pharmacist||
0124|157|R|or local waste disposal company.||
0124|158|B|||
0124|159|A|Information last revised August 2024.||
0124|160|A|Copyright(c) 2025 First Databank, Inc.||
0124|161|B|||
0126|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0126|002|Z|does NOT have all possible information about this product. This||
0126|003|Z|information does not assure that this product is safe, effective,||
0126|004|Z|or appropriate for you. This information is not individual||
0126|005|Z|medical advice and does not substitute for the advice of your||
0126|006|Z|health care professional. Always ask your health care||
0126|007|Z|professional for complete information about this product and your||
0126|008|Z|specific health needs.||
0126|009|B|||
0126|010|T|NIACIN (SUPPLEMENT) - ORAL||
0126|011|F|(NYE-a-sin)||
0126|012|B|||
0126|013|C|COMMON BRAND NAME(S): Slo-Niacin||
0126|014|B|||
0126|015|U|USES:  Niacin (nicotinic acid) is used to prevent and treat||
0126|016|U|niacin deficiency (pellagra). Niacin deficiency may result from||
0126|017|U|certain medical conditions (such as alcohol abuse, malabsorption||
0126|018|U|syndrome, Hartnup disease), poor diet, or long-term use of||
0126|019|U|certain medications (such as isoniazid).||
0126|020|U|   Niacin deficiency can cause diarrhea, confusion (dementia),||
0126|021|U|tongue redness/swelling, and peeling red skin. Niacin is also||
0126|022|U|known as vitamin B3, one of the B-complex vitamins. Vitamins help||
0126|023|U|to support the body's ability to make and break down natural||
0126|024|U|compounds (metabolism) needed for good health. Niacinamide||
0126|025|U|(nicotinamide) is a different form of vitamin B3 and does not||
0126|026|U|work the same as niacin. Do not substitute unless directed by||
0126|027|U|your doctor.||
0126|028|U|   Check the ingredients on the label even if you have used the||
0126|029|U|product before. The manufacturer may have changed the||
0126|030|U|ingredients. Also, products with similar names may contain||
0126|031|U|different ingredients meant for different purposes. Taking the||
0126|032|U|wrong product could harm you.||
0126|033|B|||
0126|034|V|OTHER USES:  This section contains uses of this drug that are not||
0126|035|V|listed in the approved professional labeling for the drug, but||
0126|036|V|may be prescribed by your health care professional. Use this drug||
0126|037|V|for a condition that is listed in this section only if it has||
0126|038|V|been so prescribed by your health care professional.||
0126|039|V|   This product may also be used to improve cholesterol and lower||
0126|040|V|fat levels (triglycerides) in the blood under the care of your||
0126|041|V|doctor. It is generally used after non-drug treatments have not||
0126|042|V|been fully successful at lowering cholesterol. Doses used for||
0126|043|V|these blood fat problems are usually much higher than for dietary||
0126|044|V|problems.||
0126|045|B|||
0126|046|H|HOW TO USE:  Take this medication by mouth with a low-fat meal or||
0126|047|H|snack as directed by your doctor, usually 1-3 times daily. Taking||
0126|048|H|niacin on an empty stomach increases side effects (such as||
0126|049|H|flushing, upset stomach). Follow all directions on the product||
0126|050|H|package. If your doctor has prescribed this medication, take it||
0126|051|H|as directed. If you have any questions, ask your doctor or||
0126|052|H|pharmacist.||
0126|053|H|   Niacin is available in different formulations (such as||
0126|054|H|immediate and sustained release). Do not switch between||
0126|055|H|strengths, brands, or forms of niacin. Severe liver problems may||
0126|056|H|occur.||
0126|057|H|   Swallow extended-release capsules whole. Do not crush or chew||
0126|058|H|extended-release capsules or tablets. Doing so can release all of||
0126|059|H|the drug at once, increasing the risk of side effects. Also, do||
0126|060|H|not split extended-release tablets unless they have a score line||
0126|061|H|and your doctor or pharmacist tells you to do so. Swallow the||
0126|062|H|whole or split tablet without crushing or chewing.||
0126|063|H|   To lessen the chance of side effects such as flushing, avoid||
0126|064|H|alcohol, hot beverages, and eating spicy foods near the time you||
0126|065|H|take niacin. Taking a plain (non-enteric coated, 325 milligram)||
0126|066|H|aspirin or a nonsteroidal anti-inflammatory drug (such as||
0126|067|H|ibuprofen, 200 milligrams) 30 minutes before taking niacin may||
0126|068|H|help prevent flushing. Ask your doctor if this treatment is right||
0126|069|H|for you.||
0126|070|H|   If you also take certain other drugs to lower cholesterol||
0126|071|H|(bile acid-binding resins such as cholestyramine or colestipol),||
0126|072|H|take niacin at least 4 to 6 hours before or after taking these||
0126|073|H|medications. These products interact with niacin, preventing its||
0126|074|H|full absorption. Continue to take other medications to lower your||
0126|075|H|cholesterol as directed by your doctor.||
0126|076|H|   The dosage is based on your medical condition and response to||
0126|077|H|treatment. If you are taking this for lipid problems, your doctor||
0126|078|H|may direct you to start this medication at a low dose and||
0126|079|H|gradually increase your dose to reduce your risk of side effects.||
0126|080|H|Your dose will need to be increased slowly even if you are||
0126|081|H|already taking niacin and are being switched from another niacin||
0126|082|H|product to this product. Follow your doctor's instructions||
0126|083|H|carefully.||
0126|084|H|   Do not stop taking this medicine unless instructed by your||
0126|085|H|doctor. If you stop taking niacin, you may need to return to your||
0126|086|H|original dose and gradually increase it again. Ask your doctor or||
0126|087|H|pharmacist for instructions on restarting your dose if you have||
0126|088|H|not taken your medication for several days.||
0126|089|H|   Use this medication regularly to get the most benefit from it.||
0126|090|H|To help you remember, take it at the same time(s) each day.||
0126|091|H|   It is very important to continue to follow your doctor's||
0126|092|H|advice about diet and exercise.||
0126|093|H|   If your condition lasts or gets worse, or if you think you may||
0126|094|H|have a serious medical problem, get medical help right away.||
0126|095|B|||
0126|096|S|SIDE EFFECTS:  Flushing/warmth in the face and neck, headache,||
0126|097|S|itching, burning, sweating, chills, or tingling may occur within||
0126|098|S|20 minutes to 4 hours of taking this medication. Flushing may||
0126|099|S|last for a few hours. These effects should improve or go away as||
0126|100|S|your body adjusts to the medication. Stomach upset, heartburn,||
0126|101|S|nausea, vomiting, and diarrhea may also occur. If any of these||
0126|102|S|effects last or get worse, tell your doctor or pharmacist||
0126|103|S|promptly.||
0126|104|S|   To reduce the risk of dizziness and lightheadedness, get up||
0126|105|S|slowly when rising from a sitting or lying position. This is very||
0126|106|S|important if you are also taking medication to lower your blood||
0126|107|S|pressure.||
0126|108|S|   Remember that this medication has been prescribed because your||
0126|109|S|doctor has judged that the benefit to you is greater than the||
0126|110|S|risk of side effects. Many people using this medication do not||
0126|111|S|have serious side effects.||
0126|112|S|   Tell your doctor right away if you have any serious side||
0126|113|S|effects, including: nausea/vomiting that doesn't stop,||
0126|114|S|fast/irregular heartbeat, severe headache (migraine), unusual||
0126|115|S|joint pain, swelling of legs/arms, vision problems, severe||
0126|116|S|stomach/abdominal pain, black stools, easy bruising/bleeding,||
0126|117|S|unexplained muscle pain/tenderness/weakness, signs of kidney||
0126|118|S|problems (such as change in the amount of urine), dark urine,||
0126|119|S|vomit that looks like coffee grounds, yellowing eyes/skin.||
0126|120|S|   A very serious allergic reaction to this drug is rare.||
0126|121|S|However, get medical help right away if you notice any symptoms||
0126|122|S|of a serious allergic reaction, including: rash, itching/swelling||
0126|123|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0126|124|S|breathing.||
0126|125|S|   This is not a complete list of possible side effects. If you||
0126|126|S|notice other effects not listed above, contact your doctor or||
0126|127|S|pharmacist.||
0126|128|S|   In the US -||
0126|129|S|   Call your doctor for medical advice about side effects. You||
0126|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0126|131|S|www.fda.gov/medwatch.||
0126|132|S|   In Canada - Call your doctor for medical advice about side||
0126|133|S|effects. You may report side effects to Health Canada at||
0126|134|S|1-866-234-2345.||
0126|135|B|||
0126|136|P|PRECAUTIONS:  Before taking niacin, tell your doctor or||
0126|137|P|pharmacist if you are allergic to it; or if you have any other||
0126|138|P|allergies. This product may contain inactive ingredients, which||
0126|139|P|can cause allergic reactions or other problems. Talk to your||
0126|140|P|pharmacist for more details.||
0126|141|P|   If you have any of the following health problems, consult your||
0126|142|P|doctor or pharmacist before using this medication: very low blood||
0126|143|P|pressure, alcohol use, history of bleeding problems (such as low||
0126|144|P|platelets), diabetes, gallbladder disease, glaucoma, gout, heart||
0126|145|P|disease (such as recent heart attack, unstable angina), kidney||
0126|146|P|disease, liver disease/increase in liver enzymes, untreated||
0126|147|P|mineral imbalance (low phosphate levels), stomach/intestinal||
0126|148|P|ulcers, underactive thyroid (hypothyroidism).||
0126|149|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0126|150|P|can make you more dizzy. Do not drive, use machinery, or do||
0126|151|P|anything that needs alertness until you can do it safely. Limit||
0126|152|P|alcoholic beverages. Talk to your doctor if you are using||
0126|153|P|marijuana (cannabis).||
0126|154|P|   Before having surgery, tell your doctor or dentist about all||
0126|155|P|the products you use (including prescription drugs,||
0126|156|P|nonprescription drugs, and herbal products).||
0126|157|P|   This medication may rarely make your blood sugar rise, which||
0126|158|P|can cause or worsen diabetes. If you already have diabetes, check||
0126|159|P|your blood sugar regularly as directed and share the results with||
0126|160|P|your doctor. Tell your doctor right away if you have symptoms of||
0126|161|P|high blood sugar such as increased thirst/urination. Your doctor||
0126|162|P|may need to adjust your diabetes medication, exercise program, or||
0126|163|P|diet.||
0126|164|P|   During pregnancy, this medication should be used only when||
0126|165|P|clearly needed. Discuss the risks and benefits with your doctor.||
0126|166|P|   This medication passes into breast milk. Consult your doctor||
0126|167|P|before breastfeeding.||
0126|168|B|||
0126|169|I|DRUG INTERACTIONS:  See also How to Use section.||
0126|170|I|   Drug interactions may change how your medications work or||
0126|171|I|increase your risk for serious side effects. This document does||
0126|172|I|not contain all possible drug interactions. Keep a list of all||
0126|173|I|the products you use (including prescription/nonprescription||
0126|174|I|drugs and herbal products) and share it with your doctor and||
0126|175|I|pharmacist. Do not start, stop, or change the dosage of any||
0126|176|I|medicines without your doctor's approval.||
0126|177|I|   Check all prescription and nonprescription medicine labels||
0126|178|I|carefully since vitamins/dietary supplements may also contain||
0126|179|I|niacin or niacinamide (nicotinamide). These may increase your||
0126|180|I|risk of side effects if taken together. Ask your doctor or||
0126|181|I|pharmacist for more details.||
0126|182|I|   This medication may interfere with certain lab tests (such as||
0126|183|I|urine or blood catecholamines, copper-based urine glucose tests),||
0126|184|I|possibly causing false test results. Make sure lab personnel and||
0126|185|I|all your doctors know you use this drug.||
0126|186|B|||
0126|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0126|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0126|189|O|poison control center right away. US residents can call||
0126|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0126|191|B|||
0126|192|N|NOTES:  If you are taking this for high cholesterol, in addition||
0126|193|N|to eating a proper diet (such as a low-cholesterol/low-fat diet),||
0126|194|N|other lifestyle changes that may help this medication work better||
0126|195|N|include exercising, losing weight if overweight, and stopping||
0126|196|N|smoking. Consult your doctor for more details.||
0126|197|N|   Remember that it is best to get your vitamins and minerals||
0126|198|N|from food whenever possible. Maintain a well-balanced diet, and||
0126|199|N|follow any dietary guidelines as directed by your doctor. B||
0126|200|N|vitamins (including niacin) are found in meat, fish, poultry,||
0126|201|N|enriched/whole grain bread products, and fortified cereals. Eat||
0126|202|N|more of these foods to increase the amount of niacin in your diet||
0126|203|N|if you have a niacin deficiency.||
0126|204|N|   There are many niacin products available. Some can be||
0126|205|N|purchased without a prescription. Consult your doctor or||
0126|206|N|pharmacist about the best product for you.||
0126|207|N|   Lab tests (such as blood lipids, blood sugar, liver function,||
0126|208|N|uric acid levels) may be done (especially if prescribed for||
0126|209|N|cholesterol/triglyceride control) while you are taking this||
0126|210|N|product. Keep all medical and lab appointments. Consult your||
0126|211|N|doctor for more details.||
0126|212|N|   Do not share this medication with others.||
0126|213|B|||
0126|214|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0126|215|D|remember. If it is near the time of the next dose, skip the||
0126|216|D|missed dose. Take your next dose at the regular time. Do not||
0126|217|D|double the dose to catch up.||
0126|218|B|||
0126|219|R|STORAGE:  Store at room temperature away from moisture and light.||
0126|220|R|Do not store in the bathroom. Refer to storage information||
0126|221|R|printed on the package. If you have any questions about storage,||
0126|222|R|ask your pharmacist. Keep all medications away from children and||
0126|223|R|pets.||
0126|224|R|   Do not flush medications down the toilet or pour them into a||
0126|225|R|drain unless instructed to do so. Properly discard this product||
0126|226|R|when it is expired or no longer needed. Consult your pharmacist||
0126|227|R|or local waste disposal company.||
0126|228|B|||
0126|229|A|Information last revised May 2024.||
0126|230|A|Copyright(c) 2025 First Databank, Inc.||
0126|231|B|||
0127|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0127|002|Z|does NOT have all possible information about this product. This||
0127|003|Z|information does not assure that this product is safe, effective,||
0127|004|Z|or appropriate for you. This information is not individual||
0127|005|Z|medical advice and does not substitute for the advice of your||
0127|006|Z|health care professional. Always ask your health care||
0127|007|Z|professional for complete information about this product and your||
0127|008|Z|specific health needs.||
0127|009|B|||
0127|010|T|PYRIDOXINE - ORAL||
0127|011|F|(PIR-i-DOX-een)||
0127|012|B|||
0127|013|C|COMMON BRAND NAME(S): Neuro-K, Vitamin B-6||
0127|014|B|||
0127|015|U|USES:  Pyridoxine (vitamin B6) is used to prevent or treat low||
0127|016|U|levels of vitamin B6 in people who do not get enough of the||
0127|017|U|vitamin from their diets. Most people who eat a normal diet do||
0127|018|U|not need extra vitamin B6. However, some conditions (such as||
0127|019|U|alcoholism, liver disease, overactive thyroid, heart failure) or||
0127|020|U|medications (such as isoniazid, cycloserine, hydralazine,||
0127|021|U|penicillamine) can cause low levels of vitamin B6. Vitamin B6||
0127|022|U|plays an important role in the body. It is needed to maintain the||
0127|023|U|health of nerves, skin, and red blood cells.||
0127|024|U|   Pyridoxine has been used to prevent or treat a certain nerve||
0127|025|U|disorder (peripheral neuropathy) caused by certain medications||
0127|026|U|(such as isoniazid). It has also been used to treat certain||
0127|027|U|hereditary disorders (such as xanthurenic aciduria,||
0127|028|U|hyperoxaluria, homocystinuria).||
0127|029|B|||
0127|030|H|HOW TO USE:  Take this vitamin by mouth with or without food,||
0127|031|H|usually once daily. Follow all directions on the product package,||
0127|032|H|or take as directed by your doctor. If you have any questions,||
0127|033|H|ask your doctor or pharmacist.||
0127|034|H|   If you are taking the extended-release capsules, swallow them||
0127|035|H|whole. Do not crush or chew extended-release capsules or tablets.||
0127|036|H|Doing so can release all of the drug at once, increasing the risk||
0127|037|H|of side effects. Swallow the whole tablet without crushing or||
0127|038|H|chewing.||
0127|039|H|   If you are using the liquid form of this product, carefully||
0127|040|H|measure the dose using a special measuring device/spoon. Do not||
0127|041|H|use a household spoon because you may not get the correct dose.||
0127|042|H|If your liquid form is a suspension, shake the container well||
0127|043|H|before each use.||
0127|044|H|   If you are taking the powder, mix it thoroughly in the proper||
0127|045|H|amount of liquid and stir well. Drink all of the liquid right||
0127|046|H|away. Do not prepare a supply for future use.||
0127|047|H|   Dosage is based on your medical condition and response to||
0127|048|H|treatment.||
0127|049|H|   Use this vitamin regularly to get the most benefit from it. To||
0127|050|H|help you remember, take it at the same time each day.||
0127|051|H|   Tell your doctor if your condition lasts or gets worse. If you||
0127|052|H|think you may have a serious medical problem, get medical help||
0127|053|H|right away.||
0127|054|B|||
0127|055|S|SIDE EFFECTS:  Pyridoxine usually has no side effects when used||
0127|056|S|in recommended doses.||
0127|057|S|   If your doctor has prescribed this medication, remember that||
0127|058|S|your doctor has judged that the benefit to you is greater than||
0127|059|S|the risk of side effects. Many people using this medication do||
0127|060|S|not have serious side effects.||
0127|061|S|   Pyridoxine can cause side effects when taken in large doses||
0127|062|S|for a long time. Tell your doctor right away if you have any||
0127|063|S|serious side effects, including: headache, nausea, drowsiness,||
0127|064|S|numbness/tingling of arms/legs.||
0127|065|S|   A very serious allergic reaction to this drug is rare.||
0127|066|S|However, get medical help right away if you notice any symptoms||
0127|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0127|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0127|069|S|breathing.||
0127|070|S|   This is not a complete list of possible side effects. If you||
0127|071|S|notice other effects not listed above, contact your doctor or||
0127|072|S|pharmacist.||
0127|073|S|   In the US -||
0127|074|S|   Call your doctor for medical advice about side effects. You||
0127|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0127|076|S|www.fda.gov/medwatch.||
0127|077|S|   In Canada - Call your doctor for medical advice about side||
0127|078|S|effects. You may report side effects to Health Canada at||
0127|079|S|1-866-234-2345.||
0127|080|B|||
0127|081|P|PRECAUTIONS:  Before taking pyridoxine, tell your doctor or||
0127|082|P|pharmacist if you are allergic to it; or if you have any other||
0127|083|P|allergies. This product may contain inactive ingredients, which||
0127|084|P|can cause allergic reactions or other problems. Talk to your||
0127|085|P|pharmacist for more details.||
0127|086|P|   Before using this vitamin, tell your doctor or pharmacist your||
0127|087|P|medical history.||
0127|088|P|   During pregnancy, this vitamin has been found to be safe when||
0127|089|P|used in recommended doses.||
0127|090|P|   This vitamin passes into breast milk and is considered to be||
0127|091|P|safe during breastfeeding when used in recommended doses. Consult||
0127|092|P|your doctor for more information.||
0127|093|B|||
0127|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0127|095|I|medications work or increase your risk for serious side effects.||
0127|096|I|This document does not contain all possible drug interactions.||
0127|097|I|Keep a list of all the products you use (including||
0127|098|I|prescription/nonprescription drugs and herbal products) and share||
0127|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
0127|100|I|the dosage of any medicines without your doctor's approval.||
0127|101|I|   A product that may interact with this vitamin is: altretamine.||
0127|102|I|   This vitamin may interfere with certain lab tests (including||
0127|103|I|urine test for urobilinogen), possibly causing false test||
0127|104|I|results. Make sure lab personnel and all your doctors know you||
0127|105|I|use this vitamin.||
0127|106|B|||
0127|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0127|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0127|109|O|poison control center right away. US residents can call||
0127|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0127|111|O|Symptoms of overdose may include: numbness/tingling of arms/legs.||
0127|112|B|||
0127|113|N|NOTES:  Keep all medical and lab appointments.||
0127|114|N|   This product is not a substitute for a proper diet. It is best||
0127|115|N|to get your vitamins from healthy foods. Vitamin B6 is commonly||
0127|116|N|found in pork, fish, chicken, whole wheat products, and beans,||
0127|117|N|among others. Consult your doctor, pharmacist, or nutritionist||
0127|118|N|for more details.||
0127|119|B|||
0127|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0127|121|D|remember. If it is near the time of the next dose, skip the||
0127|122|D|missed dose. Take your next dose at the regular time. Do not||
0127|123|D|double the dose to catch up.||
0127|124|B|||
0127|125|R|STORAGE:  Different brands of this vitamin have different storage||
0127|126|R|needs. Check the product package for instructions on how to store||
0127|127|R|your brand, or ask your pharmacist. Do not store in the bathroom.||
0127|128|R|Keep all medications away from children and pets.||
0127|129|R|   Do not flush medications down the toilet or pour them into a||
0127|130|R|drain unless instructed to do so. Properly discard this product||
0127|131|R|when it is expired or no longer needed. Consult your pharmacist||
0127|132|R|or local waste disposal company.||
0127|133|B|||
0127|134|A|Information last revised May 2024.||
0127|135|A|Copyright(c) 2025 First Databank, Inc.||
0127|136|B|||
0128|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0128|002|Z|does NOT have all possible information about this product. This||
0128|003|Z|information does not assure that this product is safe, effective,||
0128|004|Z|or appropriate for you. This information is not individual||
0128|005|Z|medical advice and does not substitute for the advice of your||
0128|006|Z|health care professional. Always ask your health care||
0128|007|Z|professional for complete information about this product and your||
0128|008|Z|specific health needs.||
0128|009|B|||
0128|010|T|ATOVAQUONE/PROGUANIL - ORAL||
0128|011|F|(a-TOE-va-kwone/proe-GWAHN-il)||
0128|012|B|||
0128|013|C|COMMON BRAND NAME(S): Malarone||
0128|014|B|||
0128|015|U|USES:  This medication contains 2 medicines: atovaquone and||
0128|016|U|proguanil. It is used to prevent and treat malaria caused by||
0128|017|U|mosquito bites in countries where malaria is common. Malaria||
0128|018|U|parasites can enter the body through these mosquito bites, and||
0128|019|U|then live in body tissues such as red blood cells or the liver.||
0128|020|U|This medication is used to kill the malaria parasites living||
0128|021|U|inside red blood cells and other tissues. In some cases, you may||
0128|022|U|need to take a different medication (such as primaquine) to||
0128|023|U|complete your treatment. Both medications may be needed for a||
0128|024|U|complete cure and to prevent the return of infection (relapse).||
0128|025|U|Atovaquone/proguanil belongs to a class of drugs known as||
0128|026|U|antimalarials.||
0128|027|U|   The United States Centers for Disease Control provide updated||
0128|028|U|guidelines and travel recommendations for the prevention and||
0128|029|U|treatment of malaria in different parts of the world. Discuss the||
0128|030|U|most recent information with your doctor before traveling to||
0128|031|U|areas where malaria occurs.||
0128|032|B|||
0128|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0128|034|H|from your pharmacist before you start taking this medication, and||
0128|035|H|each time you get a refill. If you have any questions, ask your||
0128|036|H|doctor or pharmacist.||
0128|037|H|   Take this medication by mouth with food or a milky drink (such||
0128|038|H|as whole milk, milkshake) that contains fat. If you vomit within||
0128|039|H|1 hour of taking a dose, repeat the dose. If you have vomiting||
0128|040|H|that doesn't stop after taking atovaquone/proguanil, contact a||
0128|041|H|doctor right away. You may need another medication to prevent||
0128|042|H|vomiting or a different malaria medication.||
0128|043|H|   Swallow the tablet whole because of its bitter taste. Do not||
0128|044|H|chew. If you have trouble swallowing tablets, this medication may||
0128|045|H|be crushed and mixed with condensed milk. Take the entire mixture||
0128|046|H|right away. Do not save for future use.||
0128|047|H|   The dosage is based on your medical condition and your||
0128|048|H|response to treatment. Children's dosage is also based on weight.||
0128|049|H|   To prevent illness, take atovaquone/proguanil as directed by||
0128|050|H|your doctor, usually once daily. Start this medication 1 to 2||
0128|051|H|days before you enter the malarious area and keep taking the||
0128|052|H|medication while in the area and for 7 days after leaving.||
0128|053|H|   If needed, primaquine can be taken for 14 days starting during||
0128|054|H|the last week of treatment with atovaquone/proguanil or starting||
0128|055|H|immediately after you have finished treatment.||
0128|056|H|   To treat malaria, take this medication as directed by your||
0128|057|H|doctor, usually once daily for 3 days.||
0128|058|H|   It is very important to keep taking this medication exactly as||
0128|059|H|prescribed by your doctor. To help you remember, take it at the||
0128|060|H|same time each day for the entire prescribed time.||
0128|061|H|   Do not take more or less of this drug than prescribed. Do not||
0128|062|H|stop taking this drug before completing the full treatment unless||
0128|063|H|directed to do so by your doctor, even if you feel better or do||
0128|064|H|not feel sick. Skipping or changing your dose without approval||
0128|065|H|from your doctor may cause prevention/treatment to be||
0128|066|H|ineffective, cause the amount of parasite to increase, make the||
0128|067|H|infection more difficult to treat (resistant), or worsen side||
0128|068|H|effects.||
0128|069|H|   It is important to prevent mosquito bites (such as by using||
0128|070|H|appropriate insect repellents, wearing clothes that cover most of||
0128|071|H|the body, remaining in air-conditioned or well-screened areas,||
0128|072|H|using mosquito nets and insect-killing sprays). Buy insect||
0128|073|H|repellent before traveling. The most effective insect repellents||
0128|074|H|contain diethyltoluamide (DEET). Ask your doctor or pharmacist to||
0128|075|H|recommend the appropriate strengths of mosquito repellent for||
0128|076|H|you/your children.||
0128|077|H|   No drug treatment is completely effective in preventing||
0128|078|H|malaria. Get medical help right away if you develop symptoms of||
0128|079|H|malaria (such as fever, chills, headache, other flu-like||
0128|080|H|symptoms). Malaria can return, even months after completing this||
0128|081|H|prescription. Quick treatment of malaria infection is needed to||
0128|082|H|prevent serious, possibly fatal, outcomes.||
0128|083|H|   When using atovaquone/proguanil for treatment, tell your||
0128|084|H|doctor if your condition lasts or gets worse.||
0128|085|B|||
0128|086|S|SIDE EFFECTS:  See also How to Use section.||
0128|087|S|   Nausea, vomiting, abdominal pain, headache, diarrhea,||
0128|088|S|weakness, loss of appetite, or dizziness may occur. If any of||
0128|089|S|these effects last or get worse, tell your doctor or pharmacist||
0128|090|S|promptly.||
0128|091|S|   Remember that this medication has been prescribed because your||
0128|092|S|doctor has judged that the benefit to you is greater than the||
0128|093|S|risk of side effects. Many people using this medication do not||
0128|094|S|have serious side effects.||
0128|095|S|   Tell your doctor right away if you have any serious side||
0128|096|S|effects, including: signs of serious liver problems (such as||
0128|097|S|nausea and vomiting that are severe or don't stop, abdominal||
0128|098|S|pain, unexplained tiredness, dark urine, yellowing eyes/skin),||
0128|099|S|signs of anemia (such as worsening tiredness, rapid breathing,||
0128|100|S|pale skin/lips/nails, fast heartbeat while resting), signs of||
0128|101|S|severe infection (such as high fever, severe chills, body aches,||
0128|102|S|sore throat).||
0128|103|S|   A very serious allergic reaction to this drug is rare.||
0128|104|S|However, get medical help right away if you notice any symptoms||
0128|105|S|of a serious allergic reaction, including: rash, itching/swelling||
0128|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0128|107|S|breathing.||
0128|108|S|   This is not a complete list of possible side effects. If you||
0128|109|S|notice other effects not listed above, contact your doctor or||
0128|110|S|pharmacist.||
0128|111|S|   In the US -||
0128|112|S|   Call your doctor for medical advice about side effects. You||
0128|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0128|114|S|www.fda.gov/medwatch.||
0128|115|S|   In Canada - Call your doctor for medical advice about side||
0128|116|S|effects. You may report side effects to Health Canada at||
0128|117|S|1-866-234-2345.||
0128|118|B|||
0128|119|P|PRECAUTIONS:  Before taking atovaquone/proguanil, tell your||
0128|120|P|doctor or pharmacist if you are allergic to either atovaquone or||
0128|121|P|proguanil; or if you have any other allergies. This product may||
0128|122|P|contain inactive ingredients, which can cause allergic reactions||
0128|123|P|or other problems. Talk to your pharmacist for more details.||
0128|124|P|   Before using this medication, tell your doctor or pharmacist||
0128|125|P|your medical history, especially of: current diarrhea, current||
0128|126|P|vomiting, kidney problems, liver problems, mental/mood problems,||
0128|127|P|seizures.||
0128|128|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0128|129|P|can make you more dizzy. Do not drive, use machinery, or do||
0128|130|P|anything that needs alertness until you can do it safely. Limit||
0128|131|P|alcoholic beverages. Talk to your doctor if you are using||
0128|132|P|marijuana (cannabis).||
0128|133|P|   Before having surgery, tell your doctor or dentist about all||
0128|134|P|the products you use (including prescription drugs,||
0128|135|P|nonprescription drugs, and herbal products).||
0128|136|P|   During pregnancy, this medication should be used only when||
0128|137|P|clearly needed. While you are pregnant, traveling to an area with||
0128|138|P|malaria places you and your infant at a much higher risk for||
0128|139|P|death and other problems. Discuss the risks and benefits of||
0128|140|P|malaria prevention with your doctor.||
0128|141|P|   It is unknown if atovaquone passes into breast milk. The||
0128|142|P|proguanil in this medication passes into breast milk and the||
0128|143|P|effects of this medication on a nursing infant are not known. The||
0128|144|P|CDC recommends against using this product for malaria prevention||
0128|145|P|if you are breastfeeding an infant weighing less than 11 pounds||
0128|146|P|(5 kilograms). Consult your doctor before breastfeeding.||
0128|147|B|||
0128|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0128|149|I|medications work or increase your risk for serious side effects.||
0128|150|I|This document does not contain all possible drug interactions.||
0128|151|I|Keep a list of all the products you use (including||
0128|152|I|prescription/nonprescription drugs and herbal products) and share||
0128|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
0128|154|I|the dosage of any medicines without your doctor's approval.||
0128|155|I|   Some products that may interact with this drug include:||
0128|156|I|penicillamine, "blood thinners" (such as warfarin),||
0128|157|I|metoclopramide.||
0128|158|I|   Other medications can affect the removal of||
0128|159|I|atovaquone/proguanil from your body, which may affect how||
0128|160|I|atovaquone/proguanil works. Examples include efavirenz, rifampin,||
0128|161|I|rifabutin, tetracycline, among others.||
0128|162|B|||
0128|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0128|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0128|165|O|poison control center right away. US residents can call||
0128|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0128|167|B|||
0128|168|N|NOTES:  Do not share this medication with others.||
0128|169|N|   Lab and/or medical tests (such as blood cell counts, liver||
0128|170|N|function) may be done while you are taking this medication. Keep||
0128|171|N|all medical and lab appointments. Consult your doctor for more||
0128|172|N|details.||
0128|173|B|||
0128|174|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0128|175|D|remember. If it is near the time of the next dose, skip the||
0128|176|D|missed dose. Take your next dose at the regular time. Do not||
0128|177|D|double the dose to catch up.||
0128|178|B|||
0128|179|R|STORAGE:  Store at room temperature away from light and moisture.||
0128|180|R|Do not store in the bathroom. Keep all medications away from||
0128|181|R|children and pets.||
0128|182|R|   Do not flush medications down the toilet or pour them into a||
0128|183|R|drain unless instructed to do so. Properly discard this product||
0128|184|R|when it is expired or no longer needed. Consult your pharmacist||
0128|185|R|or local waste disposal company.||
0128|186|B|||
0128|187|A|Information last revised September 2024.||
0128|188|A|Copyright(c) 2025 First Databank, Inc.||
0128|189|B|||
0129|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0129|002|Z|does NOT have all possible information about this product. This||
0129|003|Z|information does not assure that this product is safe, effective,||
0129|004|Z|or appropriate for you. This information is not individual||
0129|005|Z|medical advice and does not substitute for the advice of your||
0129|006|Z|health care professional. Always ask your health care||
0129|007|Z|professional for complete information about this product and your||
0129|008|Z|specific health needs.||
0129|009|B|||
0129|010|T|SELENIUM SULFIDE - TOPICAL||
0129|011|F|(se-LEE-nee-um SUL-fide)||
0129|012|B|||
0129|013|C|COMMON BRAND NAME(S): Selsun Blue||
0129|014|B|||
0129|015|U|USES:  This medication is used to treat dandruff and a certain||
0129|016|U|scalp infection (seborrheic dermatitis). It reduces itching,||
0129|017|U|flaking, irritation, and redness of the scalp. Selenium sulfide||
0129|018|U|is also used for a condition that causes discoloration of the||
0129|019|U|skin (tinea versicolor). This medication belongs to a class of||
0129|020|U|medications called anti-infectives. It works by slowing the||
0129|021|U|growth of the yeast that causes the infection.||
0129|022|U|   This medication is not recommended for children younger than 2||
0129|023|U|years. Consult your doctor before using this medication.||
0129|024|B|||
0129|025|H|HOW TO USE:  This medication is for use on the skin only. Some||
0129|026|H|brands require shaking before use. Check your product package to||
0129|027|H|see if your brand needs to be shaken. Before using this||
0129|028|H|medication, remove any jewelry to avoid damage to it. Avoid||
0129|029|H|getting this medication into your eyes, inside your nose or||
0129|030|H|mouth, or on any areas of broken/inflamed skin since it may cause||
0129|031|H|irritation. If this occurs, flush the area with plenty of water.||
0129|032|H|Consult your doctor or pharmacist if you have any questions about||
0129|033|H|how to use this medication properly.||
0129|034|H|   For the treatment of dandruff or scalp dermatitis, follow the||
0129|035|H|manufacturer's instructions, or use as directed by your doctor.||
0129|036|H|Wet the scalp and massage the medication onto the wet scalp.||
0129|037|H|Leave it on your scalp for 2-3 minutes and rinse thoroughly. Some||
0129|038|H|brands may require a second application. Check your product||
0129|039|H|package to see if your brand requires a repeat application. Be||
0129|040|H|sure to rinse your hair and scalp well with water after each||
0129|041|H|application, especially on bleached, tinted, or permed hair. This||
0129|042|H|medication is usually used 1 or 2 times per week to treat||
0129|043|H|dandruff or seborrheic dermatitis, or less often to maintain||
0129|044|H|control of dandruff.||
0129|045|H|   For the treatment of tinea versicolor, apply selenium sulfide||
0129|046|H|to the affected skin. Lather with a small amount of water. Allow||
0129|047|H|it to remain on your skin for 10 minutes. Rinse your skin||
0129|048|H|thoroughly with water after each use. If the medication touches||
0129|049|H|the genital areas or skin folds, rinse the area well with water||
0129|050|H|for a few minutes to prevent irritation. This medication is||
0129|051|H|applied usually once daily for 7 days to treat tinea versicolor,||
0129|052|H|or use as directed by your doctor.||
0129|053|H|   Wash your hands after using selenium sulfide. Do not leave||
0129|054|H|this medication on your hair, scalp, or skin for a longer period||
0129|055|H|or use it more often than directed. Your condition will not clear||
0129|056|H|faster, but side effects may be increased.||
0129|057|H|   Tell your doctor if your condition does not get better or if||
0129|058|H|it gets worse.||
0129|059|B|||
0129|060|S|SIDE EFFECTS:  Skin irritation, dry skin, oily or dry hair/scalp,||
0129|061|S|or temporary hair loss may occur. If any of these effects last or||
0129|062|S|get worse, discontinue use and consult your doctor or pharmacist||
0129|063|S|promptly. Hair discoloration may occur and can be reduced by||
0129|064|S|carefully rinsing the hair thoroughly after each treatment.||
0129|065|S|   If your doctor has prescribed this medication, remember that||
0129|066|S|your doctor has judged that the benefit to you is greater than||
0129|067|S|the risk of side effects. Many people using this medication do||
0129|068|S|not have serious side effects.||
0129|069|S|   A very serious allergic reaction to this drug is rare.||
0129|070|S|However, get medical help right away if you notice any symptoms||
0129|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0129|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0129|073|S|breathing.||
0129|074|S|   This is not a complete list of possible side effects. If you||
0129|075|S|notice other effects not listed above, contact your doctor or||
0129|076|S|pharmacist.||
0129|077|S|   In the US -||
0129|078|S|   Call your doctor for medical advice about side effects. You||
0129|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0129|080|S|www.fda.gov/medwatch.||
0129|081|S|   In Canada - Call your doctor for medical advice about side||
0129|082|S|effects. You may report side effects to Health Canada at||
0129|083|S|1-866-234-2345.||
0129|084|B|||
0129|085|P|PRECAUTIONS:  Before using selenium sulfide, tell your doctor or||
0129|086|P|pharmacist if you are allergic to it; or if you have any other||
0129|087|P|allergies. This product may contain inactive ingredients, which||
0129|088|P|can cause allergic reactions or other problems. Talk to your||
0129|089|P|pharmacist for more details.||
0129|090|P|   Before using this medication, tell your doctor or pharmacist||
0129|091|P|your medical history, especially of: red/irritated/broken skin.||
0129|092|P|   Before having surgery, tell your doctor or dentist about all||
0129|093|P|the products you use (including prescription drugs,||
0129|094|P|nonprescription drugs, and herbal products).||
0129|095|P|   If you are using selenium sulfide on the body for tinea||
0129|096|P|versicolor, this medication should be used during pregnancy only||
0129|097|P|when clearly needed. Discuss the risks and benefits with your||
0129|098|P|doctor.||
0129|099|P|   It is unknown if this drug passes into breast milk. Consult||
0129|100|P|your doctor before breastfeeding.||
0129|101|B|||
0129|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0129|103|I|medications work or increase your risk for serious side effects.||
0129|104|I|This document does not contain all possible drug interactions.||
0129|105|I|Keep a list of all the products you use (including||
0129|106|I|prescription/nonprescription drugs and herbal products) and share||
0129|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
0129|108|I|the dosage of any medicines without your doctor's approval.||
0129|109|B|||
0129|110|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0129|111|O|has overdosed and has serious symptoms such as passing out or||
0129|112|O|trouble breathing, call 911. Otherwise, call a poison control||
0129|113|O|center right away. US residents can call 1-800-222-1222. Canada||
0129|114|O|residents can call 1-844-764-7669.||
0129|115|B|||
0129|116|N|NOTES:  Keep all medical and lab appointments.||
0129|117|B|||
0129|118|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0129|119|D|If it is near the time of the next dose, skip the missed dose.||
0129|120|D|Use your next dose at the regular time. Do not double the dose to||
0129|121|D|catch up.||
0129|122|B|||
0129|123|R|STORAGE:  Store at room temperature. Avoid freezing. Keep all||
0129|124|R|medications away from children and pets.||
0129|125|R|   Do not flush medications down the toilet or pour them into a||
0129|126|R|drain unless instructed to do so. Properly discard this product||
0129|127|R|when it is expired or no longer needed. Consult your pharmacist||
0129|128|R|or local waste disposal company.||
0129|129|B|||
0129|130|A|Information last revised January 2025.||
0129|131|A|Copyright(c) 2025 First Databank, Inc.||
0129|132|B|||
0130|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0130|002|Z|does NOT have all possible information about this product. This||
0130|003|Z|information does not assure that this product is safe, effective,||
0130|004|Z|or appropriate for you. This information is not individual||
0130|005|Z|medical advice and does not substitute for the advice of your||
0130|006|Z|health care professional. Always ask your health care||
0130|007|Z|professional for complete information about this product and your||
0130|008|Z|specific health needs.||
0130|009|B|||
0130|010|T|SILVER SULFADIAZINE - TOPICAL||
0130|011|F|(SIL-ver SIL-fa-DYE-a-zeen)||
0130|012|B|||
0130|013|C|COMMON BRAND NAME(S): Silvadene||
0130|014|B|||
0130|015|U|USES:  This medication is used with other treatments to help||
0130|016|U|prevent and treat wound infections in patients with serious||
0130|017|U|burns. Silver sulfadiazine works by stopping the growth of||
0130|018|U|bacteria that may infect an open wound. This helps to decrease||
0130|019|U|the risk of the bacteria spreading to surrounding skin, or to the||
0130|020|U|blood where it can cause a serious blood infection (sepsis).||
0130|021|U|Silver sulfadiazine belongs to a class of drugs known as sulfa||
0130|022|U|antibiotics.||
0130|023|U|   Silver sulfadiazine must not be used on premature babies or on||
0130|024|U|newborns during the first 2 months of life because of the risk of||
0130|025|U|serious side effects.||
0130|026|B|||
0130|027|V|OTHER USES:  This section contains uses of this drug that are not||
0130|028|V|listed in the approved professional labeling for the drug but||
0130|029|V|that may be prescribed by your health care professional. Use this||
0130|030|V|drug for a condition that is listed in this section only if it||
0130|031|V|has been so prescribed by your health care professional.||
0130|032|V|   This drug may also be used for other skin and wound infections||
0130|033|V|(such as skin ulcers).||
0130|034|B|||
0130|035|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0130|036|H|from your pharmacist before you start using silver sulfadiazine||
0130|037|H|and each time you get a refill. If you have any questions, ask||
0130|038|H|your doctor or pharmacist.||
0130|039|H|   This medication is for use on the skin only. Avoid using this||
0130|040|H|medication around your eyes unless directed to do so by your||
0130|041|H|doctor.||
0130|042|H|   Your health care professional will clean and remove the dead||
0130|043|H|tissue from the wound to help the healing process.||
0130|044|H|   Apply this medication to the wound using sterile technique||
0130|045|H|(such as wearing sterile gloves and using sterile application||
0130|046|H|tools), as directed by your doctor, usually 1 to 2 times daily.||
0130|047|H|The layer of medication should be about one-sixteenth of an inch||
0130|048|H|(1-2 millimeters) thick or as directed. The wound should be||
0130|049|H|covered with the cream at all times. Dressings may be applied||
0130|050|H|over the cream, but only if needed. If some of the cream rubs off||
0130|051|H|the wound, reapply it immediately. The cream should also be||
0130|052|H|reapplied immediately after hydrotherapy.||
0130|053|H|   Treatment usually continues until the wound is completely||
0130|054|H|healed or until the site is ready for skin grafting.||
0130|055|H|   Use this medication regularly to get the most benefit from it.||
0130|056|H|To help you remember, use it at the same time(s) each day.||
0130|057|H|   Tell your doctor if your condition lasts or if it gets worse.||
0130|058|B|||
0130|059|S|SIDE EFFECTS:  Pain, burning, or itching of the treated skin may||
0130|060|S|occur. Skin and mucous membranes (such as the gums) may become||
0130|061|S|blue/gray in color. If any of these effects last or get worse,||
0130|062|S|tell your doctor or pharmacist promptly.||
0130|063|S|   Remember that this medication has been prescribed because your||
0130|064|S|doctor has judged that the benefit to you is greater than the||
0130|065|S|risk of side effects. Many people using this medication do not||
0130|066|S|have serious side effects.||
0130|067|S|   Tell your doctor right away if you have any serious side||
0130|068|S|effects, including: signs of infection (such as sore throat that||
0130|069|S|doesn't go away, fever, chills), easy bruising/bleeding, signs of||
0130|070|S|anemia (such as unusual tiredness/weakness, rapid breathing, fast||
0130|071|S|heartbeat), signs of kidney problems (such as change in the||
0130|072|S|amount of urine, pink/bloody urine), signs of liver problems||
0130|073|S|(such as nausea that doesn't stop, stomach/abdominal pain,||
0130|074|S|vomiting, dark urine, yellowing eyes/skin), mental/mood changes.||
0130|075|S|   A very serious allergic reaction to this drug is rare.||
0130|076|S|However, get medical help right away if you notice any symptoms||
0130|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0130|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0130|079|S|breathing.||
0130|080|S|   This is not a complete list of possible side effects. If you||
0130|081|S|notice other effects not listed above, contact your doctor or||
0130|082|S|pharmacist.||
0130|083|S|   In the US -||
0130|084|S|   Call your doctor for medical advice about side effects. You||
0130|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0130|086|S|www.fda.gov/medwatch.||
0130|087|S|   In Canada - Call your doctor for medical advice about side||
0130|088|S|effects. You may report side effects to Health Canada at||
0130|089|S|1-866-234-2345.||
0130|090|B|||
0130|091|P|PRECAUTIONS:  Before using silver sulfadiazine, tell your doctor||
0130|092|P|or pharmacist if you are allergic to it; or to other sulfa||
0130|093|P|antibiotics (such as sulfamethoxazole); or if you have any other||
0130|094|P|allergies. This product may contain inactive ingredients, which||
0130|095|P|can cause allergic reactions or other problems. Talk to your||
0130|096|P|pharmacist for more details.||
0130|097|P|   Before using this medication, tell your doctor or pharmacist||
0130|098|P|your medical history, especially of: a certain enzyme deficiency||
0130|099|P|(G6PD or glucose-6-phosphate dehydrogenase deficiency), kidney||
0130|100|P|problems, liver problems, low white blood cell count.||
0130|101|P|   Before having surgery, tell your doctor or dentist about all||
0130|102|P|the products you use (including prescription drugs,||
0130|103|P|nonprescription drugs, and herbal products).||
0130|104|P|   During pregnancy, this medication should be used only when||
0130|105|P|clearly needed. This medication must not be used near the||
0130|106|P|expected delivery date because of possible harm to the unborn||
0130|107|P|baby. Discuss the risks and benefits with your doctor.||
0130|108|P|   It is unknown if this medication passes into breast milk.||
0130|109|P|However, similar drugs pass into breast milk and may harm nursing||
0130|110|P|infants who are ill, premature, less than 2 months old, or who||
0130|111|P|have certain disorders (such as jaundice, high blood levels of||
0130|112|P|bilirubin, G6PD deficiency). Breastfeeding is not recommended||
0130|113|P|while using this medication in infants with these conditions.||
0130|114|P|Consult your doctor before breastfeeding.||
0130|115|B|||
0130|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0130|117|I|medications work or increase your risk for serious side effects.||
0130|118|I|This document does not contain all possible drug interactions.||
0130|119|I|Keep a list of all the products you use (including||
0130|120|I|prescription/nonprescription drugs and herbal products) and share||
0130|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
0130|122|I|the dosage of any medicines without your doctor's approval.||
0130|123|I|   Some products that may interact with this drug include: skin||
0130|124|I|products containing sodium sulfacetamide, enzyme products used to||
0130|125|I|break down and remove dead skin/tissue from burns and wounds||
0130|126|I|(such as collagenase, papain, trypsin).||
0130|127|I|   An inactive ingredient in some brands of this medication||
0130|128|I|(propylene glycol) may be absorbed and may interfere with certain||
0130|129|I|lab tests, possibly causing false test results. Make sure lab||
0130|130|I|personnel and all your doctors know you use this drug.||
0130|131|B|||
0130|132|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0130|133|O|has overdosed and has serious symptoms such as passing out or||
0130|134|O|trouble breathing, call 911. Otherwise, call a poison control||
0130|135|O|center right away. US residents can call 1-800-222-1222. Canada||
0130|136|O|residents can call 1-844-764-7669.||
0130|137|B|||
0130|138|N|NOTES:  Do not share this medication with others.||
0130|139|N|   Do not smoke or go near open flames while using this||
0130|140|N|medication. Doing so may increase the risk of severe burns.||
0130|141|N|Fabric (such as clothing, bedding, dressings) that has been in||
0130|142|N|contact with this medication burns more easily and may be a fire||
0130|143|N|hazard. Washing clothing and bedding may reduce the build-up of||
0130|144|N|product but will not remove all of it.||
0130|145|N|   Lab and/or medical tests (such as white blood cell count,||
0130|146|N|kidney function, blood tests) should be done while you are using||
0130|147|N|this medication. Keep all medical and lab appointments. Consult||
0130|148|N|your doctor for more details.||
0130|149|B|||
0130|150|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0130|151|D|This medicine should be on the wounds at all times as directed by||
0130|152|D|your doctor.||
0130|153|B|||
0130|154|R|STORAGE:  Different brands of this medication have different||
0130|155|R|storage needs. Check the product package for instructions on how||
0130|156|R|to store your brand, or ask your pharmacist. Keep all medications||
0130|157|R|away from children and pets.||
0130|158|R|   Do not flush medications down the toilet or pour them into a||
0130|159|R|drain unless instructed to do so. Properly discard this product||
0130|160|R|when it is expired or no longer needed. Consult your pharmacist||
0130|161|R|or local waste disposal company.||
0130|162|B|||
0130|163|A|Information last revised September 2024.||
0130|164|A|Copyright(c) 2025 First Databank, Inc.||
0130|165|B|||
0131|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0131|002|Z|does NOT have all possible information about this product. This||
0131|003|Z|information does not assure that this product is safe, effective,||
0131|004|Z|or appropriate for you. This information is not individual||
0131|005|Z|medical advice and does not substitute for the advice of your||
0131|006|Z|health care professional. Always ask your health care||
0131|007|Z|professional for complete information about this product and your||
0131|008|Z|specific health needs.||
0131|009|B|||
0131|010|T|THIAMINE - ORAL||
0131|011|F|(THYE-a-min)||
0131|012|B|||
0131|013|C|COMMON BRAND NAME(S): Thiamilate||
0131|014|B|||
0131|015|U|USES:  Thiamine (vitamin B1) is used to prevent or treat low||
0131|016|U|levels of vitamin B1 in people who do not get enough of the||
0131|017|U|vitamin from their diets. Most people who eat a normal diet do||
0131|018|U|not need extra vitamin B1. However, some conditions (such as||
0131|019|U|alcoholism, cirrhosis, stomach/intestinal problems) can cause low||
0131|020|U|levels of vitamin B1. Vitamin B1 plays an important role in the||
0131|021|U|body. It is needed to maintain the health of the nerves and the||
0131|022|U|heart. Low levels of vitamin B1 may cause heart failure and||
0131|023|U|mental/nerve problems.||
0131|024|B|||
0131|025|H|HOW TO USE:  Take this vitamin by mouth with or without food,||
0131|026|H|usually 1 to 3 times daily. Follow all directions on the product||
0131|027|H|package, or take as directed by your doctor. If you have any||
0131|028|H|questions, ask your doctor or pharmacist.||
0131|029|H|   If you are using the liquid form of this medication, shake the||
0131|030|H|bottle well before each dose. Carefully measure the dose using a||
0131|031|H|special measuring device/spoon. Do not use a household spoon||
0131|032|H|because you may not get the correct dose.||
0131|033|H|   The dosage is based on your medical condition and response to||
0131|034|H|treatment.||
0131|035|H|   Use this vitamin regularly to get the most benefit from it. To||
0131|036|H|help you remember, take it at the same time(s) each day.||
0131|037|H|   Tell your doctor if your condition lasts or gets worse. If you||
0131|038|H|think you may have a serious medical problem, get medical help||
0131|039|H|right away.||
0131|040|B|||
0131|041|S|SIDE EFFECTS:  This vitamin usually has no side effects. If you||
0131|042|S|have any unusual effects, contact your doctor or pharmacist||
0131|043|S|promptly.||
0131|044|S|   A very serious allergic reaction to this drug is rare.||
0131|045|S|However, get medical help right away if you notice any symptoms||
0131|046|S|of a serious allergic reaction, including: rash, itching/swelling||
0131|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0131|048|S|breathing.||
0131|049|S|   This is not a complete list of possible side effects. If you||
0131|050|S|notice other effects not listed above, contact your doctor or||
0131|051|S|pharmacist.||
0131|052|S|   In the US -||
0131|053|S|   Call your doctor for medical advice about side effects. You||
0131|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0131|055|S|www.fda.gov/medwatch.||
0131|056|S|   In Canada - Call your doctor for medical advice about side||
0131|057|S|effects. You may report side effects to Health Canada at||
0131|058|S|1-866-234-2345.||
0131|059|B|||
0131|060|P|PRECAUTIONS:  Before taking thiamine, tell your doctor or||
0131|061|P|pharmacist if you are allergic to it; or if you have any other||
0131|062|P|allergies. This product may contain inactive ingredients, which||
0131|063|P|can cause allergic reactions or other problems. Talk to your||
0131|064|P|pharmacist for more details.||
0131|065|P|   Before having surgery, tell your doctor or dentist about all||
0131|066|P|the products you use (including prescription drugs,||
0131|067|P|nonprescription drugs, and herbal products).||
0131|068|P|   During pregnancy, this vitamin has been found to be safe when||
0131|069|P|used in recommended doses. Higher doses during pregnancy should||
0131|070|P|be used only when clearly needed. Discuss the risks and benefits||
0131|071|P|with your doctor.||
0131|072|P|   This vitamin passes into breast milk and is considered to be||
0131|073|P|safe during breastfeeding when used in recommended doses. Consult||
0131|074|P|your doctor for more information.||
0131|075|B|||
0131|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0131|077|I|medications work or increase your risk for serious side effects.||
0131|078|I|This document does not contain all possible drug interactions.||
0131|079|I|Keep a list of all the products you use (including||
0131|080|I|prescription/nonprescription drugs and herbal products) and share||
0131|081|I|it with your doctor and pharmacist. Do not start, stop, or change||
0131|082|I|the dosage of any medicines without your doctor's approval.||
0131|083|I|   This vitamin may interfere with certain lab tests (such as||
0131|084|I|uric acid levels, urobilinogen urine test), possibly causing||
0131|085|I|false test results. Make sure lab personnel and all your doctors||
0131|086|I|know you use this vitamin.||
0131|087|B|||
0131|088|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0131|089|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0131|090|O|poison control center right away. US residents can call||
0131|091|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0131|092|B|||
0131|093|N|NOTES:  Lab and/or medical tests (such as thiamine levels) may be||
0131|094|N|done while you are using this medication. Keep all medical and||
0131|095|N|lab appointments. Consult your doctor for more details.||
0131|096|N|   This product is not a substitute for a proper diet. It is best||
0131|097|N|to get your vitamins from healthy foods. Thiamine is commonly||
0131|098|N|found in cereal grains, bread, pork, and beans, among others.||
0131|099|N|Consult your doctor, pharmacist, or nutritionist for more||
0131|100|N|details.||
0131|101|B|||
0131|102|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0131|103|D|remember. If it is near the time of the next dose, skip the||
0131|104|D|missed dose. Take your next dose at the regular time. Do not||
0131|105|D|double the dose to catch up.||
0131|106|B|||
0131|107|R|STORAGE:  Different brands of this vitamin have different storage||
0131|108|R|needs. Check the product package for instructions on how to store||
0131|109|R|your brand, or ask your pharmacist. Do not store in the bathroom.||
0131|110|R|Keep all medications away from children and pets.||
0131|111|R|   Do not flush medications down the toilet or pour them into a||
0131|112|R|drain unless instructed to do so. Properly discard this product||
0131|113|R|when it is expired or no longer needed. Consult your pharmacist||
0131|114|R|or local waste disposal company.||
0131|115|B|||
0131|116|A|Information last revised April 2025.||
0131|117|A|Copyright(c) 2025 First Databank, Inc.||
0131|118|B|||
0132|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0132|002|Z|does NOT have all possible information about this product. This||
0132|003|Z|information does not assure that this product is safe, effective,||
0132|004|Z|or appropriate for you. This information is not individual||
0132|005|Z|medical advice and does not substitute for the advice of your||
0132|006|Z|health care professional. Always ask your health care||
0132|007|Z|professional for complete information about this product and your||
0132|008|Z|specific health needs.||
0132|009|B|||
0132|010|T|TRIMETHOBENZAMIDE - ORAL||
0132|011|F|(trye-METH-oh-BEN-za-mide)||
0132|012|B|||
0132|013|C|COMMON BRAND NAME(S): Tigan||
0132|014|B|||
0132|015|U|USES:  Trimethobenzamide is used to treat nausea and vomiting||
0132|016|U|that may occur after surgery or with a certain stomach/intestinal||
0132|017|U|problem (gastroenteritis). Treating vomiting quickly can prevent||
0132|018|U|dehydration.||
0132|019|U|   This medication is not recommended for use in children due to||
0132|020|U|risk of serious side effects.||
0132|021|B|||
0132|022|H|HOW TO USE:  Take this medication by mouth as directed by your||
0132|023|H|doctor, usually 3 to 4 times a day.||
0132|024|H|   The dosage is based on your medical condition, age, and||
0132|025|H|response to treatment. Do not increase your dose or use this drug||
0132|026|H|more often or for longer than prescribed. Your condition will not||
0132|027|H|improve any faster, and your risk of side effects will increase.||
0132|028|H|   Tell your doctor if your condition lasts or gets worse.||
0132|029|B|||
0132|030|S|SIDE EFFECTS:  Diarrhea, headache, dizziness, drowsiness, or||
0132|031|S|blurred vision may occur. If any of these effects last or get||
0132|032|S|worse, tell your doctor or pharmacist promptly.||
0132|033|S|   Remember that this medication has been prescribed because your||
0132|034|S|doctor has judged that the benefit to you is greater than the||
0132|035|S|risk of side effects. Many people using this medication do not||
0132|036|S|have serious side effects.||
0132|037|S|   Tell your doctor right away if you have any serious side||
0132|038|S|effects, including: mental/mood changes (such as depression,||
0132|039|S|confusion, restlessness), yellowing eyes/skin, dark urine, muscle||
0132|040|S|spasms, unusual uncontrolled movements (especially of the face,||
0132|041|S|mouth, tongue, arms, or legs), severe arching of the back,||
0132|042|S|shaking (tremor).||
0132|043|S|   Get medical help right away if you have any very serious side||
0132|044|S|effects, including: seizures.||
0132|045|S|   A very serious allergic reaction to this drug is rare.||
0132|046|S|However, get medical help right away if you notice any symptoms||
0132|047|S|of a serious allergic reaction, including: rash, itching/swelling||
0132|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0132|049|S|breathing.||
0132|050|S|   This is not a complete list of possible side effects. If you||
0132|051|S|notice other effects not listed above, contact your doctor or||
0132|052|S|pharmacist.||
0132|053|S|   In the US -||
0132|054|S|   Call your doctor for medical advice about side effects. You||
0132|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0132|056|S|www.fda.gov/medwatch.||
0132|057|S|   In Canada - Call your doctor for medical advice about side||
0132|058|S|effects. You may report side effects to Health Canada at||
0132|059|S|1-866-234-2345.||
0132|060|B|||
0132|061|P|PRECAUTIONS:  Before taking trimethobenzamide, tell your doctor||
0132|062|P|or pharmacist if you are allergic to it; or if you have any other||
0132|063|P|allergies. This product may contain inactive ingredients, which||
0132|064|P|can cause allergic reactions or other problems. Talk to your||
0132|065|P|pharmacist for more details.||
0132|066|P|   Before using this medication, tell your doctor or pharmacist||
0132|067|P|your medical history, especially of: liver disease, kidney||
0132|068|P|problems, stomach/intestinal problems (such as appendicitis),||
0132|069|P|swelling/disease of the brain (encephalitis/encephalopathy),||
0132|070|P|dehydration, electrolytes imbalance.||
0132|071|P|   This drug may make you dizzy or drowsy or blur your vision.||
0132|072|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0132|073|P|drowsy. Do not drive, use machinery, or do anything that needs||
0132|074|P|alertness or clear vision until you can do it safely. Avoid||
0132|075|P|alcoholic beverages. Talk to your doctor if you are using||
0132|076|P|marijuana (cannabis).||
0132|077|P|   Before having surgery, tell your doctor or dentist about all||
0132|078|P|the products you use (including prescription drugs,||
0132|079|P|nonprescription drugs, and herbal products).||
0132|080|P|   Older adults may be more sensitive to the side effects of this||
0132|081|P|drug, especially unusual uncontrolled movements and shaking.||
0132|082|P|   During pregnancy, this medication should be used only when||
0132|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
0132|084|P|   It is unknown if this drug passes into breast milk. Consult||
0132|085|P|your doctor before breastfeeding.||
0132|086|B|||
0132|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0132|088|I|medications work or increase your risk for serious side effects.||
0132|089|I|This document does not contain all possible drug interactions.||
0132|090|I|Keep a list of all the products you use (including||
0132|091|I|prescription/nonprescription drugs and herbal products) and share||
0132|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
0132|093|I|the dosage of any medicines without your doctor's approval.||
0132|094|I|   Tell your doctor or pharmacist if you are taking other||
0132|095|I|products that cause drowsiness such as opioid pain or cough||
0132|096|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0132|097|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0132|098|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0132|099|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0132|100|I|diphenhydramine).||
0132|101|I|   Check the labels on all your medicines (such as allergy or||
0132|102|I|cough-and-cold products) because they may contain ingredients||
0132|103|I|that cause drowsiness. Ask your pharmacist about using those||
0132|104|I|products safely.||
0132|105|B|||
0132|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0132|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0132|108|O|poison control center right away. US residents can call||
0132|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0132|110|B|||
0132|111|N|NOTES:  Do not share this medication with others.||
0132|112|B|||
0132|113|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0132|114|D|remember. If it is near the time of the next dose, skip the||
0132|115|D|missed dose. Take your next dose at the regular time. Do not||
0132|116|D|double the dose to catch up.||
0132|117|B|||
0132|118|R|STORAGE:  Store at room temperature away from light and moisture.||
0132|119|R|Do not store in the bathroom. Keep all medications away from||
0132|120|R|children and pets.||
0132|121|R|   Do not flush medications down the toilet or pour them into a||
0132|122|R|drain unless instructed to do so. Properly discard this product||
0132|123|R|when it is expired or no longer needed. Consult your pharmacist||
0132|124|R|or local waste disposal company.||
0132|125|B|||
0132|126|A|Information last revised May 2024.||
0132|127|A|Copyright(c) 2025 First Databank, Inc.||
0132|128|B|||
0133|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0133|002|Z|does NOT have all possible information about this product. This||
0133|003|Z|information does not assure that this product is safe, effective,||
0133|004|Z|or appropriate for you. This information is not individual||
0133|005|Z|medical advice and does not substitute for the advice of your||
0133|006|Z|health care professional. Always ask your health care||
0133|007|Z|professional for complete information about this product and your||
0133|008|Z|specific health needs.||
0133|009|B|||
0133|010|T|ETOPOSIDE - ORAL||
0133|011|F|(e-TOE-poe-side)||
0133|012|B|||
0133|013|C|COMMON BRAND NAME(S): Vepesid||
0133|014|B|||
0133|015|W|WARNING:  This medication may cause certain severe blood and bone||
0133|016|W|marrow problems (low red blood cells/white blood||
0133|017|W|cells/platelets). This can affect your body's ability to stop||
0133|018|W|bleeding or fight infection. Tell your doctor right away if you||
0133|019|W|develop unusual tiredness, signs of infection (such as sore||
0133|020|W|throat that doesn't go away, fever, chills), or easy||
0133|021|W|bruising/bleeding (such as black stools, bloody vomit).||
0133|022|B|||
0133|023|U|USES:  Etoposide is used to treat certain forms of lung cancer||
0133|024|U|(such as small cell lung cancer). Etoposide works by slowing the||
0133|025|U|growth of cancer cells.||
0133|026|B|||
0133|027|V|OTHER USES:  This section contains uses of this drug that are not||
0133|028|V|listed in the approved professional labeling for the drug but||
0133|029|V|that may be prescribed by your health care professional. Use this||
0133|030|V|drug for a condition that is listed in this section only if it||
0133|031|V|has been so prescribed by your health care professional.||
0133|032|V|   This medication may also be used for certain types of||
0133|033|V|leukemias and lymphomas, ovarian cancer, testicular cancer, and a||
0133|034|V|certain type of prostate cancer.||
0133|035|B|||
0133|036|H|HOW TO USE:  Take this medication by mouth with or without food||
0133|037|H|as directed by your doctor. The dosage is based on your medical||
0133|038|H|condition and response to treatment.||
0133|039|H|   Do not increase your dose or use this drug more often or for||
0133|040|H|longer than prescribed. Your condition will not improve any||
0133|041|H|faster, and your risk of side effects will increase.||
0133|042|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0133|043|H|using this medication unless your doctor or pharmacist says you||
0133|044|H|may do so safely. Grapefruit can affect the removal of etoposide||
0133|045|H|from your body, which may affect how etoposide works. Ask your||
0133|046|H|doctor or pharmacist for more details.||
0133|047|H|   Since this drug can be absorbed through the skin and lungs and||
0133|048|H|may harm an unborn baby, women who are pregnant or who may become||
0133|049|H|pregnant should not handle this medication or breathe the dust||
0133|050|H|from the capsules.||
0133|051|B|||
0133|052|S|SIDE EFFECTS:  See also Warning section.||
0133|053|S|   Nausea, vomiting, loss of appetite, or diarrhea may occur.||
0133|054|S|Nausea and vomiting can be severe. In some cases, your doctor may||
0133|055|S|prescribe medication to prevent or relieve nausea and vomiting.||
0133|056|S|Eating several small meals, not eating before treatment, or||
0133|057|S|limiting activity may help lessen some of these effects. If any||
0133|058|S|of these effects last or get worse, tell your doctor or||
0133|059|S|pharmacist promptly.||
0133|060|S|   Temporary hair loss may occur. Normal hair growth should||
0133|061|S|return after treatment has ended.||
0133|062|S|   Pain or sores in the mouth and throat may occur. Brush your||
0133|063|S|teeth carefully/gently, avoid using mouthwash that contains||
0133|064|S|alcohol, and rinse your mouth often with cool water mixed with||
0133|065|S|baking soda or salt. It may also be best to eat soft, moist||
0133|066|S|foods.||
0133|067|S|   People using this medication may have serious side effects.||
0133|068|S|However, you have been prescribed this drug because your doctor||
0133|069|S|has judged that the benefit to you is greater than the risk of||
0133|070|S|side effects. Careful monitoring by your doctor may decrease your||
0133|071|S|risk.||
0133|072|S|   This medication may lower your ability to fight infections.||
0133|073|S|This may make you more likely to get a serious (rarely fatal)||
0133|074|S|infection or make any infection you have worse. Tell your doctor||
0133|075|S|right away if you have any signs of infection (such as sore||
0133|076|S|throat that doesn't go away, fever, chills).||
0133|077|S|   Tell your doctor right away if you have any serious side||
0133|078|S|effects, including: numbness/tingling of arms/legs, sudden vision||
0133|079|S|changes, eye pain, stomach/abdominal pain, yellowing eyes/skin,||
0133|080|S|dark urine, painful/difficult swallowing.||
0133|081|S|   Although etoposide may be used to treat certain leukemias, it||
0133|082|S|may rarely cause acute leukemia. Ask your doctor for more||
0133|083|S|details.||
0133|084|S|   A very serious allergic reaction to this drug is rare.||
0133|085|S|However, get medical help right away if you notice any symptoms||
0133|086|S|of a serious allergic reaction, including: rash, itching/swelling||
0133|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0133|088|S|breathing, fast heartbeat, seizures.||
0133|089|S|   This is not a complete list of possible side effects. If you||
0133|090|S|notice other effects not listed above, contact your doctor or||
0133|091|S|pharmacist.||
0133|092|S|   In the US -||
0133|093|S|   Call your doctor for medical advice about side effects. You||
0133|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0133|095|S|www.fda.gov/medwatch.||
0133|096|S|   In Canada - Call your doctor for medical advice about side||
0133|097|S|effects. You may report side effects to Health Canada at||
0133|098|S|1-866-234-2345.||
0133|099|B|||
0133|100|P|PRECAUTIONS:  Before taking etoposide, tell your doctor or||
0133|101|P|pharmacist if you are allergic to it; or if you have any other||
0133|102|P|allergies. This product may contain inactive ingredients, which||
0133|103|P|can cause allergic reactions or other problems. Talk to your||
0133|104|P|pharmacist for more details.||
0133|105|P|   Before using this medication, tell your doctor or pharmacist||
0133|106|P|your medical history, especially of: kidney disease, liver||
0133|107|P|disease, blood problems (such as low red blood cells/white blood||
0133|108|P|cells/platelets), previous radiation/chemotherapy treatment.||
0133|109|P|   Etoposide can make you more likely to get infections or may||
0133|110|P|make current infections worse. Stay away from anyone who has an||
0133|111|P|infection that may easily spread (such as chickenpox, COVID-19,||
0133|112|P|measles, flu). Talk to your doctor if you have been exposed to an||
0133|113|P|infection or for more details.||
0133|114|P|   Tell your health care professional that you are using||
0133|115|P|etoposide before having any immunizations/vaccinations. Avoid||
0133|116|P|contact with people who have recently received live vaccines||
0133|117|P|(such as flu vaccine inhaled through the nose).||
0133|118|P|   To lower the chance of getting cut, bruised, or injured, use||
0133|119|P|caution with sharp objects like razors and nail cutters, and||
0133|120|P|avoid activities such as contact sports.||
0133|121|P|   Daily use of alcohol while using this medicine may increase||
0133|122|P|your risk for stomach bleeding. Limit alcoholic beverages.||
0133|123|P|Consult your doctor or pharmacist for more information.||
0133|124|P|   Before having surgery, tell your doctor or dentist about all||
0133|125|P|the products you use (including prescription drugs,||
0133|126|P|nonprescription drugs, and herbal products).||
0133|127|P|   Older adults may be more sensitive to the side effects of this||
0133|128|P|drug, especially drowsiness, weakness, mouth/throat sores, loss||
0133|129|P|of appetite, low white blood cells, and dehydration.||
0133|130|P|   This medication can affect fertility in both males and||
0133|131|P|females. Ask your doctor for more details.||
0133|132|P|   Tell your doctor if you are pregnant or plan to become||
0133|133|P|pregnant. You should not become pregnant while using etoposide.||
0133|134|P|Etoposide may harm an unborn baby. Women using this medication||
0133|135|P|should ask about reliable forms of birth control during treatment||
0133|136|P|and for 6 months after the last dose. Men using this medication||
0133|137|P|should ask about reliable forms of birth control during treatment||
0133|138|P|and for 4 months after the last dose. If you or your partner||
0133|139|P|becomes pregnant, talk to your doctor right away about the risks||
0133|140|P|and benefits of this medication.||
0133|141|P|   Since this drug can be absorbed through the skin and lungs and||
0133|142|P|may harm an unborn baby, women who are pregnant or who may become||
0133|143|P|pregnant should not handle this medication or breathe the dust||
0133|144|P|from the capsules.||
0133|145|P|   Etoposide passes into breast milk. Because of the possible||
0133|146|P|risk to the infant, breastfeeding is not recommended while using||
0133|147|P|this medication. Consult your doctor before breastfeeding.||
0133|148|B|||
0133|149|I|DRUG INTERACTIONS:  See also How to Use section.||
0133|150|I|   Drug interactions may change how your medications work or||
0133|151|I|increase your risk for serious side effects. This document does||
0133|152|I|not contain all possible drug interactions. Keep a list of all||
0133|153|I|the products you use (including prescription/nonprescription||
0133|154|I|drugs and herbal products) and share it with your doctor and||
0133|155|I|pharmacist. Do not start, stop, or change the dosage of any||
0133|156|I|medicines without your doctor's approval.||
0133|157|B|||
0133|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0133|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0133|160|O|poison control center right away. US residents can call||
0133|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0133|162|B|||
0133|163|N|NOTES:  Do not share this medication with others.||
0133|164|N|   Lab and/or medical tests (such as complete blood cell counts,||
0133|165|N|kidney/liver function) should be done while you are taking this||
0133|166|N|medication. Keep all medical and lab appointments. Consult your||
0133|167|N|doctor for more details.||
0133|168|B|||
0133|169|D|MISSED DOSE:  It is important to take each dose of etoposide as||
0133|170|D|scheduled. If you miss a dose, ask your doctor or pharmacist||
0133|171|D|right away for a new dosing schedule. Do not double the dose to||
0133|172|D|catch up.||
0133|173|B|||
0133|174|R|STORAGE:  Different brands of this medication have different||
0133|175|R|storage needs. Check the product package for instructions on how||
0133|176|R|to store your brand, or ask your pharmacist. Keep all medications||
0133|177|R|away from children and pets.||
0133|178|R|   Do not flush medications down the toilet or pour them into a||
0133|179|R|drain unless instructed to do so. Properly discard this product||
0133|180|R|when it is expired or no longer needed. Consult your pharmacist||
0133|181|R|or local waste disposal company.||
0133|182|B|||
0133|183|M|MEDICAL ALERT:  Your condition can cause complications in a||
0133|184|M|medical emergency. For information about enrolling in MedicAlert,||
0133|185|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0133|186|B|||
0133|187|A|Information last revised April 2025.||
0133|188|A|Copyright(c) 2025 First Databank, Inc.||
0133|189|B|||
0134|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0134|002|Z|does NOT have all possible information about this product. This||
0134|003|Z|information does not assure that this product is safe, effective,||
0134|004|Z|or appropriate for you. This information is not individual||
0134|005|Z|medical advice and does not substitute for the advice of your||
0134|006|Z|health care professional. Always ask your health care||
0134|007|Z|professional for complete information about this product and your||
0134|008|Z|specific health needs.||
0134|009|B|||
0134|010|T|BLEOMYCIN - INJECTION||
0134|011|F|(BLEE-oh-MYE-sin)||
0134|012|B|||
0134|013|C|COMMON BRAND NAME(S): Blenoxane||
0134|014|B|||
0134|015|W|WARNING:  Rarely, bleomycin can cause a serious, allergic-like||
0134|016|W|reaction. It is most common in lymphoma patients. Before your||
0134|017|W|main treatment with this drug begins, your doctor may direct you||
0134|018|W|to receive a smaller test dose to check for signs of this serious||
0134|019|W|reaction. Tell your doctor right away if any of the following||
0134|020|W|serious side effects occur: dizziness/fainting, confusion, fever,||
0134|021|W|chills, trouble breathing.||
0134|022|W|   Severe (sometimes fatal) lung problems (lung scarring) have||
0134|023|W|rarely occurred in patients using this drug. This reaction is||
0134|024|W|more likely in patients older than 70 years. The risk of this||
0134|025|W|reaction increases as you receive more doses of this drug. This||
0134|026|W|problem may occur anytime during treatment. Tell your doctor||
0134|027|W|right away if you experience any of these serious side effects:||
0134|028|W|cough, fever, chills, chest pain, or difficult/painful breathing.||
0134|029|B|||
0134|030|U|USES:  Bleomycin is used to treat cancer. It works by slowing or||
0134|031|U|stopping the growth of cancer cells.||
0134|032|U|   This medication may also be used to control the build-up of||
0134|033|U|fluid around the lungs (pleural effusion) caused by tumors that||
0134|034|U|have spread to the lungs. For this condition, bleomycin is placed||
0134|035|U|in the space around the lungs through a chest tube.||
0134|036|B|||
0134|037|H|HOW TO USE:  This medication is given by injection into a vein,||
0134|038|H|into a muscle, or under the skin by a health care professional.||
0134|039|H|It is given as directed by your doctor, usually once or twice a||
0134|040|H|week. When giving this medication into a vein, it is injected||
0134|041|H|slowly over 10 minutes. Tell your health care professional right||
0134|042|H|away if you experience any chest pain. The medication may need to||
0134|043|H|be stopped or injected more slowly. The dosage is based on your||
0134|044|H|medical condition, body size, and response to treatment.||
0134|045|H|   If you are receiving this medication through a chest tube into||
0134|046|H|the space around the lungs, the solution is usually left in place||
0134|047|H|for 4 hours and then drained out through the chest tube. Your||
0134|048|H|doctor may direct you to change positions during the 4 hours to||
0134|049|H|make sure the solution treats all parts of your lungs.||
0134|050|B|||
0134|051|S|SIDE EFFECTS:  See also Warning section.||
0134|052|S|   Pain/redness at the injection site, fever, chills, vomiting,||
0134|053|S|loss of appetite, weight loss, darkening of the skin, or changes||
0134|054|S|in fingernails/toenails may occur. Changes in diet such as eating||
0134|055|S|several small meals or limiting activity may help lessen some of||
0134|056|S|these effects. In some cases, drug treatment may be necessary to||
0134|057|S|prevent or relieve nausea and vomiting. If any of these effects||
0134|058|S|last or get worse, tell your doctor or pharmacist promptly.||
0134|059|S|   Temporary hair loss may occur. Normal hair growth should||
0134|060|S|return after treatment has ended.||
0134|061|S|   People using this medication may have serious side effects.||
0134|062|S|However, you have been prescribed this drug because your doctor||
0134|063|S|has judged that the benefit to you is greater than the risk of||
0134|064|S|side effects. Careful monitoring by your doctor may decrease your||
0134|065|S|risk.||
0134|066|S|   Painful sores on the lips, mouth, and throat may occur. To||
0134|067|S|decrease the risk, limit hot foods and drinks, brush your teeth||
0134|068|S|carefully, avoid using mouthwash that contains alcohol, and rinse||
0134|069|S|your mouth often with cool water.||
0134|070|S|   Bleomycin can commonly cause skin reactions (such as redness,||
0134|071|S|itching, blisters, rash, swelling), usually in the second or||
0134|072|S|third week of treatment. These reactions are not always serious.||
0134|073|S|However, you may not be able to tell them apart from signs of a||
0134|074|S|severe reaction. Tell your doctor right away if you develop any||
0134|075|S|skin reaction.||
0134|076|S|   Tell your doctor right away if you have any serious side||
0134|077|S|effects, including: nausea that doesn't stop, dizziness/fainting,||
0134|078|S|fast/pounding heartbeat, numbness/tingling, feeling of coldness||
0134|079|S|in hands/feet, easy bruising/bleeding, pale/bluish skin, coughing||
0134|080|S|up blood, vomit that looks bloody or like coffee grounds, signs||
0134|081|S|of infection (such as sore throat that doesn't go away, fever,||
0134|082|S|chills), signs of kidney problems (such as change in the amount||
0134|083|S|of urine, pink urine), mental/mood changes (such as confusion,||
0134|084|S|aggression), stomach/abdominal pain, dark urine, yellowing||
0134|085|S|eyes/skin.||
0134|086|S|   Get medical help right away if you have any very serious side||
0134|087|S|effects, including: weakness on one side of the body, vision||
0134|088|S|changes, trouble speaking, chest pain.||
0134|089|S|   A very serious allergic reaction to this drug is rare.||
0134|090|S|However, get medical help right away if you notice any symptoms||
0134|091|S|of a serious allergic reaction, including: confusion, rash,||
0134|092|S|itching/swelling (especially of the face/tongue/throat), severe||
0134|093|S|dizziness, trouble breathing.||
0134|094|S|   This is not a complete list of possible side effects. If you||
0134|095|S|notice other effects not listed above, contact your doctor or||
0134|096|S|pharmacist.||
0134|097|S|   In the US -||
0134|098|S|   Call your doctor for medical advice about side effects. You||
0134|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0134|100|S|www.fda.gov/medwatch.||
0134|101|S|   In Canada - Call your doctor for medical advice about side||
0134|102|S|effects. You may report side effects to Health Canada at||
0134|103|S|1-866-234-2345.||
0134|104|B|||
0134|105|P|PRECAUTIONS:  Before using bleomycin, tell your doctor or||
0134|106|P|pharmacist if you are allergic to it; or if you have any other||
0134|107|P|allergies. This product may contain inactive ingredients, which||
0134|108|P|can cause allergic reactions or other problems. Talk to your||
0134|109|P|pharmacist for more details.||
0134|110|P|   Before using this medication, tell your doctor or pharmacist||
0134|111|P|your medical history, especially: immune system problems (such as||
0134|112|P|chemotherapy, bone marrow problems), kidney disease, liver||
0134|113|P|disease, lung problems.||
0134|114|P|   This medication may make your lungs more sensitive to oxygen||
0134|115|P|treatment. Tell your doctor or dentist that you have used this||
0134|116|P|medication before having surgery or any treatment where oxygen||
0134|117|P|may be used.||
0134|118|P|   Older adults may be at greater risk for side effects (such as||
0134|119|P|lung problems) while using this drug.||
0134|120|P|   Tell your doctor if you are pregnant or plan to become||
0134|121|P|pregnant. You should not become pregnant while using bleomycin.||
0134|122|P|Bleomycin may harm an unborn baby. If you become pregnant, talk||
0134|123|P|to your doctor right away about the risks and benefits of this||
0134|124|P|medication.||
0134|125|P|   It is unknown if this drug passes into breast milk. Because of||
0134|126|P|the possible risk to the infant, breastfeeding is not recommended||
0134|127|P|while using this drug. Consult your doctor before breastfeeding.||
0134|128|B|||
0134|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0134|130|I|medications work or increase your risk for serious side effects.||
0134|131|I|This document does not contain all possible drug interactions.||
0134|132|I|Keep a list of all the products you use (including||
0134|133|I|prescription/nonprescription drugs and herbal products) and share||
0134|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
0134|135|I|the dosage of any medicines without your doctor's approval.||
0134|136|I|   Some products that may interact with this drug include:||
0134|137|I|brentuximab, digoxin, drugs that may harm the kidneys (for||
0134|138|I|example, aminoglycosides such as gentamicin, cisplatin),||
0134|139|I|phenytoin.||
0134|140|B|||
0134|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0134|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0134|143|O|poison control center right away. US residents can call||
0134|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0134|145|B|||
0134|146|N|NOTES:  Lab and/or medical tests (such as chest X-rays, complete||
0134|147|N|blood counts, kidney/liver function) should be done while you are||
0134|148|N|using this medication. Keep all medical and lab appointments.||
0134|149|N|Consult your doctor for more details.||
0134|150|B|||
0134|151|D|MISSED DOSE:  It is important to get each dose of this medication||
0134|152|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0134|153|D|right away for a new dosing schedule.||
0134|154|B|||
0134|155|R|STORAGE:  Not applicable. This medication is given in a hospital||
0134|156|R|or clinic and will not be stored at home.||
0134|157|B|||
0134|158|A|Information last revised April 2025.||
0134|159|A|Copyright(c) 2025 First Databank, Inc.||
0134|160|B|||
0135|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0135|002|Z|does NOT have all possible information about this product. This||
0135|003|Z|information does not assure that this product is safe, effective,||
0135|004|Z|or appropriate for you. This information is not individual||
0135|005|Z|medical advice and does not substitute for the advice of your||
0135|006|Z|health care professional. Always ask your health care||
0135|007|Z|professional for complete information about this product and your||
0135|008|Z|specific health needs.||
0135|009|B|||
0135|010|T|BUSULFAN - ORAL||
0135|011|F|(bue-SUL-fan)||
0135|012|B|||
0135|013|C|COMMON BRAND NAME(S): Myleran||
0135|014|B|||
0135|015|W|WARNING:  This medication decreases bone marrow function, an||
0135|016|W|effect that may lead to a low number of blood cells such as red||
0135|017|W|cells, white cells, and platelets. This effect can cause anemia,||
0135|018|W|decrease your body's ability to fight an infection, or cause you||
0135|019|W|to bruise or bleed more easily. Tell your doctor right away if||
0135|020|W|you develop any of the following symptoms: signs of an infection||
0135|021|W|(such as sore throat that doesn't go away, fever, chills), easy||
0135|022|W|bruising/bleeding, pale skin, unusual tiredness.||
0135|023|W|   Your doctor will monitor you closely while you are taking this||
0135|024|W|medication. Keep all medical and lab appointments.||
0135|025|B|||
0135|026|U|USES:  Busulfan is used to treat chronic myelogenous leukemia||
0135|027|U|(CML). It does not cure the disease but helps to control it so||
0135|028|U|that your quality of life is improved.||
0135|029|B|||
0135|030|V|OTHER USES:  This section contains uses of this drug that are not||
0135|031|V|listed in the approved professional labeling for the drug but||
0135|032|V|that may be prescribed by your health care professional. Use this||
0135|033|V|drug for a condition that is listed in this section only if it||
0135|034|V|has been so prescribed by your health care professional.||
0135|035|V|   This drug may also be used as a pretreatment for patients who||
0135|036|V|are undergoing stem cell transplant.||
0135|037|B|||
0135|038|H|HOW TO USE:  Take this medication by mouth with or without food||
0135|039|H|as directed by your doctor, usually once daily.||
0135|040|H|   The dosage is based on your weight, medical condition, lab||
0135|041|H|tests, and response to treatment. Your treatment may be stopped||
0135|042|H|for a short time if your blood counts are too low. Keep all||
0135|043|H|medical and lab appointments.||
0135|044|H|   Do not increase your dose or take this medication more often||
0135|045|H|than prescribed. Your condition will not improve any faster, and||
0135|046|H|the risk of serious side effects may be increased.||
0135|047|H|   Since this drug can be absorbed through the skin and lungs,||
0135|048|H|women who are pregnant or who may become pregnant should not||
0135|049|H|handle this medication or breathe the dust from the tablets.||
0135|050|H|   Tell your doctor if your condition does not get better or if||
0135|051|H|it gets worse.||
0135|052|B|||
0135|053|S|SIDE EFFECTS:  See also Warning section.||
0135|054|S|   Darkening skin or dry mouth may occur. If any of these effects||
0135|055|S|last or get worse, tell your doctor or pharmacist promptly.||
0135|056|S|   Many people using this medication may have serious side||
0135|057|S|effects. However, you have been prescribed this drug because your||
0135|058|S|doctor has judged that the benefit to you is greater than the||
0135|059|S|risk of side effects. Careful monitoring by your doctor may||
0135|060|S|decrease your risk.||
0135|061|S|   Tell your doctor right away if you have any serious side||
0135|062|S|effects, including: signs of liver disease (such as||
0135|063|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain,||
0135|064|S|yellowing skin/eyes, dark urine), seizures, unusual/extreme||
0135|065|S|tiredness, painful urination, toe/joint pain, fainting,||
0135|066|S|fast/pounding heartbeat, cloudy/blurred vision.||
0135|067|S|   Busulfan has rarely caused very serious (possibly fatal) lung||
0135|068|S|disease. This may occur after months to years of using busulfan.||
0135|069|S|Tell your doctor right away if you develop symptoms of lung||
0135|070|S|disease, including cough that doesn't go away, chest pain,||
0135|071|S|shortness of breath.||
0135|072|S|   Busulfan may cause other cancers (such as acute leukemia,||
0135|073|S|tumors). Consult your doctor for more details. Tell your doctor||
0135|074|S|right away if you notice any symptoms of cancer, including||
0135|075|S|unusual lumps, sudden weight loss.||
0135|076|S|   A very serious allergic reaction to this drug is rare.||
0135|077|S|However, get medical help right away if you notice any symptoms||
0135|078|S|of a serious allergic reaction, including: rash, itching/swelling||
0135|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0135|080|S|breathing.||
0135|081|S|   This is not a complete list of possible side effects. If you||
0135|082|S|notice other effects not listed above, contact your doctor or||
0135|083|S|pharmacist.||
0135|084|S|   In the US -||
0135|085|S|   Call your doctor for medical advice about side effects. You||
0135|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0135|087|S|www.fda.gov/medwatch.||
0135|088|S|   In Canada - Call your doctor for medical advice about side||
0135|089|S|effects. You may report side effects to Health Canada at||
0135|090|S|1-866-234-2345.||
0135|091|B|||
0135|092|P|PRECAUTIONS:  Before taking busulfan, tell your doctor or||
0135|093|P|pharmacist if you are allergic to it; or if you have any other||
0135|094|P|allergies. This product may contain inactive ingredients, which||
0135|095|P|can cause allergic reactions or other problems. Talk to your||
0135|096|P|pharmacist for more details.||
0135|097|P|   Before using this medication, tell your doctor or pharmacist||
0135|098|P|your medical history, especially of: blood/bone marrow disorders||
0135|099|P|(such as bone marrow suppression, neutropenia, thrombocytopenia,||
0135|100|P|anemia), brain disorders (such as seizures, head injury).||
0135|101|P|   Busulfan can make you more likely to get infections or may||
0135|102|P|make current infections worse. Stay away from anyone who has an||
0135|103|P|infection that may easily spread (such as chickenpox, COVID-19,||
0135|104|P|measles, flu). Talk to your doctor if you have been exposed to an||
0135|105|P|infection or for more details.||
0135|106|P|   Tell your health care professional that you are using busulfan||
0135|107|P|before having any immunizations/vaccinations. Avoid contact with||
0135|108|P|people who have recently received live vaccines (such as flu||
0135|109|P|vaccine inhaled through the nose).||
0135|110|P|   To lower the chance of getting cut, bruised, or injured, use||
0135|111|P|caution with sharp objects like razors and nail cutters, and||
0135|112|P|avoid activities such as contact sports.||
0135|113|P|   Before having surgery, tell your doctor or dentist about all||
0135|114|P|the products you use (including prescription drugs,||
0135|115|P|nonprescription drugs, and herbal products).||
0135|116|P|   In female children, this medication may prevent puberty.||
0135|117|P|Contact the doctor for more information.||
0135|118|P|   This medication can affect fertility in both males and||
0135|119|P|females. Ask your doctor for more details.||
0135|120|P|   Tell your doctor if you are pregnant or plan to become||
0135|121|P|pregnant. You should not become pregnant while using busulfan.||
0135|122|P|Busulfan may harm an unborn baby. Women using this medication||
0135|123|P|should ask about reliable forms of birth control during treatment||
0135|124|P|and for at least 6 months after the last dose. Men using this||
0135|125|P|medication should ask about reliable forms of birth control||
0135|126|P|during treatment and for at least 3 months after the last dose.||
0135|127|P|If you or your partner becomes pregnant, talk to your doctor||
0135|128|P|right away about the risks and benefits of this medication.||
0135|129|P|   It is unknown if this drug passes into breast milk. Because of||
0135|130|P|the possible risk to the infant, breastfeeding is not recommended||
0135|131|P|while using this drug. Consult your doctor before breastfeeding.||
0135|132|B|||
0135|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0135|134|I|medications work or increase your risk for serious side effects.||
0135|135|I|This document does not contain all possible drug interactions.||
0135|136|I|Keep a list of all the products you use (including||
0135|137|I|prescription/nonprescription drugs and herbal products) and share||
0135|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
0135|139|I|the dosage of any medicines without your doctor's approval.||
0135|140|B|||
0135|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0135|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0135|143|O|poison control center right away. US residents can call||
0135|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0135|145|O|Symptoms of overdose include: easy bruising/bleeding, pale skin,||
0135|146|O|unusual tiredness.||
0135|147|B|||
0135|148|N|NOTES:  Do not share this medication with others.||
0135|149|N|   Lab and/or medical tests (such as complete blood count,||
0135|150|N|hematocrit/hemoglobin, liver function) must be done while you are||
0135|151|N|taking this medication. Keep all medical and lab appointments.||
0135|152|N|Consult your doctor for more details.||
0135|153|B|||
0135|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0135|155|D|remember. If it is near the time of the next dose, skip the||
0135|156|D|missed dose. Take your next dose at the regular time. Do not||
0135|157|D|double the dose to catch up.||
0135|158|B|||
0135|159|R|STORAGE:  Store at room temperature away from light and moisture.||
0135|160|R|Do not store in the bathroom. Keep all medications away from||
0135|161|R|children and pets.||
0135|162|R|   Do not flush medications down the toilet or pour them into a||
0135|163|R|drain unless instructed to do so. Properly discard this product||
0135|164|R|when it is expired or no longer needed. Consult your pharmacist||
0135|165|R|or local waste disposal company.||
0135|166|B|||
0135|167|M|MEDICAL ALERT:  Your condition can cause complications in a||
0135|168|M|medical emergency. For information about enrolling in MedicAlert,||
0135|169|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0135|170|B|||
0135|171|A|Information last revised October 2024.||
0135|172|A|Copyright(c) 2025 First Databank, Inc.||
0135|173|B|||
0136|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0136|002|Z|does NOT have all possible information about this product. This||
0136|003|Z|information does not assure that this product is safe, effective,||
0136|004|Z|or appropriate for you. This information is not individual||
0136|005|Z|medical advice and does not substitute for the advice of your||
0136|006|Z|health care professional. Always ask your health care||
0136|007|Z|professional for complete information about this product and your||
0136|008|Z|specific health needs.||
0136|009|B|||
0136|010|T|MEGESTROL - ORAL||
0136|011|F|(me-JES-trol)||
0136|012|B|||
0136|013|C|COMMON BRAND NAME(S): Megace||
0136|014|B|||
0136|015|U|USES:  This medication is used to treat cancer of the breast or||
0136|016|U|uterus. Megestrol is similar to a natural substance made by your||
0136|017|U|body called progesterone.||
0136|018|B|||
0136|019|V|OTHER USES:  This section contains uses of this drug that are not||
0136|020|V|listed in the approved professional labeling for the drug but||
0136|021|V|that may be prescribed by your health care professional. Use this||
0136|022|V|drug for a condition that is listed in this section only if it||
0136|023|V|has been so prescribed by your health care professional.||
0136|024|V|   This drug may also be used for cancer of the ovaries or||
0136|025|V|prostate. It may also be used to counter unhealthy weight loss in||
0136|026|V|people with certain conditions (such as cancer, AIDS) by||
0136|027|V|improving their appetite.||
0136|028|B|||
0136|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
0136|030|H|doctor. The dosage and how often you take this medication are||
0136|031|H|based on your medical condition and response to treatment. Follow||
0136|032|H|your doctor's instructions carefully.||
0136|033|H|   Use this medication regularly to get the most benefit from it.||
0136|034|H|To help you remember, take it at the same time(s) each day.||
0136|035|H|   Do not increase your dose or use this drug more often or for||
0136|036|H|longer than prescribed. Your condition will not improve any||
0136|037|H|faster, and your risk of side effects will increase.||
0136|038|H|   Since this drug can be absorbed through the skin and lungs and||
0136|039|H|may harm an unborn baby, women who are pregnant or who may become||
0136|040|H|pregnant should not handle this medication or breathe the dust||
0136|041|H|from the tablets.||
0136|042|B|||
0136|043|S|SIDE EFFECTS:  Trouble sleeping, fever, gas, decreased sexual||
0136|044|S|ability/desire, weight gain, changes in appetite, or upset||
0136|045|S|stomach may occur. Women may have changes in their menstrual||
0136|046|S|periods, including unpredictable bleeding. If any of these||
0136|047|S|effects last or get worse, tell your doctor or pharmacist||
0136|048|S|promptly.||
0136|049|S|   Remember that this medication has been prescribed because your||
0136|050|S|doctor has judged that the benefit to you is greater than the||
0136|051|S|risk of side effects. Many people using this medication do not||
0136|052|S|have serious side effects.||
0136|053|S|   Tell your doctor right away if you have any serious side||
0136|054|S|effects, including: fast/pounding heartbeat, tiredness, headache,||
0136|055|S|swelling of the hands/feet.||
0136|056|S|   This medication may rarely make your blood sugar rise, which||
0136|057|S|can cause or worsen diabetes. Tell your doctor right away if you||
0136|058|S|have symptoms of high blood sugar such as increased||
0136|059|S|thirst/urination. If you already have diabetes, check your blood||
0136|060|S|sugar regularly as directed and share the results with your||
0136|061|S|doctor. Your doctor may need to adjust your diabetes medication,||
0136|062|S|exercise program, or diet.||
0136|063|S|   Get medical help right away if you have any very serious side||
0136|064|S|effects, including: symptoms of a blood clot (such as chest pain,||
0136|065|S|trouble breathing, pain/redness/swelling of arms or legs),||
0136|066|S|confusion, mental/mood changes, weakness/numbness on one side of||
0136|067|S|the body, trouble speaking, vision changes.||
0136|068|S|   A very serious allergic reaction to this drug is rare.||
0136|069|S|However, get medical help right away if you notice any symptoms||
0136|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0136|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0136|072|S|breathing.||
0136|073|S|   This is not a complete list of possible side effects. If you||
0136|074|S|notice other effects not listed above, contact your doctor or||
0136|075|S|pharmacist.||
0136|076|S|   In the US -||
0136|077|S|   Call your doctor for medical advice about side effects. You||
0136|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0136|079|S|www.fda.gov/medwatch.||
0136|080|S|   In Canada - Call your doctor for medical advice about side||
0136|081|S|effects. You may report side effects to Health Canada at||
0136|082|S|1-866-234-2345.||
0136|083|B|||
0136|084|P|PRECAUTIONS:  Before taking megestrol, tell your doctor or||
0136|085|P|pharmacist if you are allergic to it; or if you have any other||
0136|086|P|allergies. This product may contain inactive ingredients, which||
0136|087|P|can cause allergic reactions or other problems. Talk to your||
0136|088|P|pharmacist for more details.||
0136|089|P|   Before using this medication, tell your doctor or pharmacist||
0136|090|P|your medical history, especially of: adrenal gland problems (such||
0136|091|P|as Cushing's syndrome), blood clots, diabetes, heart disease||
0136|092|P|(such as heart failure), high blood pressure, kidney disease,||
0136|093|P|stomach or abdominal problems, unusual vaginal bleeding.||
0136|094|P|   If you have diabetes, this product may affect your blood||
0136|095|P|sugar. Check your blood sugar regularly as directed and share the||
0136|096|P|results with your doctor. Tell your doctor right away if you have||
0136|097|P|symptoms of high blood sugar (see Side Effects section). Your||
0136|098|P|doctor may need to adjust your diabetes medication, exercise||
0136|099|P|program, or diet.||
0136|100|P|   Using megestrol for a long time may make it more difficult for||
0136|101|P|your body to respond to physical stress. Before having surgery or||
0136|102|P|emergency treatment, or if you get a serious illness/injury, tell||
0136|103|P|your doctor or dentist that you are using this medication or have||
0136|104|P|recently stopped taking it. Tell your doctor right away if you||
0136|105|P|develop unusual/extreme tiredness, dizziness, nausea, or||
0136|106|P|vomiting.||
0136|107|P|   Older adults may be more sensitive to the side effects of this||
0136|108|P|drug, especially the risk for blood clots.||
0136|109|P|   Tell your doctor if you are pregnant or plan to become||
0136|110|P|pregnant. You should not become pregnant while using megestrol.||
0136|111|P|Megestrol may harm an unborn baby. Your doctor should order a||
0136|112|P|pregnancy test before starting this medication. Ask about||
0136|113|P|reliable forms of birth control while using this medication. If||
0136|114|P|you become pregnant, talk to your doctor right away about the||
0136|115|P|risks and benefits of this medication.||
0136|116|P|   Since this drug can be absorbed through the skin and lungs and||
0136|117|P|may harm an unborn baby, women who are pregnant or who may become||
0136|118|P|pregnant should not handle this medication or breathe the dust||
0136|119|P|from the tablets.||
0136|120|P|   This medication passes into breast milk. Because of the||
0136|121|P|possible risk to the infant, breastfeeding is not recommended||
0136|122|P|while using this medication. Consult your doctor before||
0136|123|P|breastfeeding.||
0136|124|B|||
0136|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0136|126|I|medications work or increase your risk for serious side effects.||
0136|127|I|This document does not contain all possible drug interactions.||
0136|128|I|Keep a list of all the products you use (including||
0136|129|I|prescription/nonprescription drugs and herbal products) and share||
0136|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
0136|131|I|the dosage of any medicines without your doctor's approval.||
0136|132|I|   A product that may interact with this drug is: dofetilide.||
0136|133|B|||
0136|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0136|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0136|136|O|poison control center right away. US residents can call||
0136|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0136|138|B|||
0136|139|N|NOTES:  Do not share this medication with others.||
0136|140|N|   Lab and/or medical tests (such as blood pressure, blood sugar)||
0136|141|N|may be done while you are taking this medication. Keep all||
0136|142|N|medical and lab appointments. Consult your doctor for more||
0136|143|N|details.||
0136|144|B|||
0136|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0136|146|D|remember. If it is near the time of the next dose, skip the||
0136|147|D|missed dose. Take your next dose at the regular time. Do not||
0136|148|D|double the dose to catch up.||
0136|149|B|||
0136|150|R|STORAGE:  Store at room temperature away from light and moisture.||
0136|151|R|Do not store in the bathroom. Keep all medications away from||
0136|152|R|children and pets.||
0136|153|R|   Do not flush medications down the toilet or pour them into a||
0136|154|R|drain unless instructed to do so. Properly discard this product||
0136|155|R|when it is expired or no longer needed. Consult your pharmacist||
0136|156|R|or local waste disposal company.||
0136|157|B|||
0136|158|A|Information last revised May 2024.||
0136|159|A|Copyright(c) 2025 First Databank, Inc.||
0136|160|B|||
0137|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0137|002|Z|does NOT have all possible information about this product. This||
0137|003|Z|information does not assure that this product is safe, effective,||
0137|004|Z|or appropriate for you. This information is not individual||
0137|005|Z|medical advice and does not substitute for the advice of your||
0137|006|Z|health care professional. Always ask your health care||
0137|007|Z|professional for complete information about this product and your||
0137|008|Z|specific health needs.||
0137|009|B|||
0137|010|T|VINBLASTINE - INJECTION||
0137|011|F|(vin-BLAS-teen)||
0137|012|B|||
0137|013|C|COMMON BRAND NAME(S): Velban||
0137|014|B|||
0137|015|W|WARNING:  If vinblastine accidentally leaks into tissue around||
0137|016|W|the injection site, the skin and/or muscle may be severely||
0137|017|W|damaged. Tell your doctor right away if you feel pain or||
0137|018|W|irritation at the injection site. This drug is injected into a||
0137|019|W|vein only. This medication must not be injected under the skin,||
0137|020|W|into a muscle, or into the spine.||
0137|021|W|   Deaths have occurred when vinblastine was injected into the||
0137|022|W|spine. This medication should be clearly labeled for injection||
0137|023|W|into a vein only. To prevent accidental injection into the spine,||
0137|024|W|do not remove the syringe from its labeled outside cover until||
0137|025|W|immediately before use.||
0137|026|B|||
0137|027|U|USES:  Vinblastine is used to treat cancer. It works by slowing||
0137|028|U|or stopping the growth of cancer cells.||
0137|029|B|||
0137|030|H|HOW TO USE:  This medication is given by injection into a vein by||
0137|031|H|a health care professional. It is given as directed by your||
0137|032|H|doctor, usually once a week. To prevent leakage of the medication||
0137|033|H|into tissue around the vein, vinblastine should be injected over||
0137|034|H|1 minute. Tell your health care professional right away if you||
0137|035|H|experience pain, burning, or redness at the injection site. This||
0137|036|H|medication should not be mixed in a large amount of solution||
0137|037|H|and/or injected over a long time (such as 30 to 60 minutes)||
0137|038|H|unless directed by your doctor. Doing so may increase the risk of||
0137|039|H|leakage. If the medication starts to leak into tissue, the||
0137|040|H|injection should be stopped and the remaining solution should be||
0137|041|H|given into a different vein.||
0137|042|H|   The dosage is based on your medical condition, body size, and||
0137|043|H|response to treatment. Your doctor will do blood tests (complete||
0137|044|H|blood count) to find the right dose for you. Your next dose may||
0137|045|H|need to be rescheduled if your white blood cell count is too low.||
0137|046|H|   Avoid getting this medication in your eye. If this occurs,||
0137|047|H|wash the affected eye(s) well and contact your doctor.||
0137|048|H|   Unless your doctor instructs you otherwise, drink plenty of||
0137|049|H|fluids while taking this medication. Doing so helps your kidneys||
0137|050|H|to remove the drug from your body and avoid some of the side||
0137|051|H|effects.||
0137|052|B|||
0137|053|S|SIDE EFFECTS:  See also Warning section.||
0137|054|S|   Pain/redness at the injection site, nausea, vomiting,||
0137|055|S|constipation, tiredness, and loss of appetite may occur. Nausea||
0137|056|S|and vomiting can be severe. In some cases, your doctor may||
0137|057|S|prescribe medication to prevent or relieve nausea and vomiting.||
0137|058|S|Eating several small meals, not eating before treatment, or||
0137|059|S|limiting activity may help lessen some of these effects. If these||
0137|060|S|effects last or get worse, tell your doctor or pharmacist||
0137|061|S|promptly.||
0137|062|S|   To prevent constipation, eat dietary fiber, drink enough||
0137|063|S|water, and exercise. You may also need to take a laxative. Ask||
0137|064|S|your pharmacist which type of laxative is right for you.||
0137|065|S|   Temporary hair loss is another common side effect. Normal hair||
0137|066|S|growth should return after treatment has ended.||
0137|067|S|   Many people using this medication may have serious side||
0137|068|S|effects. However, you have been prescribed this drug because your||
0137|069|S|doctor has judged that the benefit to you is greater than the||
0137|070|S|risk of side effects. Careful monitoring by your doctor may||
0137|071|S|decrease your risk.||
0137|072|S|   Painful sores on the lips, mouth, and throat may occur. To||
0137|073|S|decrease the risk, limit hot foods and drinks, brush your teeth||
0137|074|S|carefully, avoid using mouthwash that contains alcohol, and rinse||
0137|075|S|your mouth often with cool water.||
0137|076|S|   Tell your doctor right away if you have any serious side||
0137|077|S|effects, including: easy bleeding/bruising, fast/pounding||
0137|078|S|heartbeat, abdominal/stomach pain, bone/jaw pain, severe||
0137|079|S|headache, hearing problems, unusual lumps/skin changes,||
0137|080|S|dizziness/feeling of spinning, mental/mood changes (such as||
0137|081|S|depression), pale/bluish fingers/toes, pain/coldness in||
0137|082|S|fingers/toes, numbness/tingling, difficult/painful urination,||
0137|083|S|pink/bloody urine.||
0137|084|S|   Get medical help right away if you have any very serious side||
0137|085|S|effects, including: sudden shortness of breath/wheezing,||
0137|086|S|black/tarry stools, chest/left arm pain, confusion, seizures,||
0137|087|S|trouble speaking, weakness on one side of the body, vision||
0137|088|S|changes, vomit that looks like coffee grounds.||
0137|089|S|   This medication can lower the body's ability to fight an||
0137|090|S|infection. Tell your doctor right away if you develop any signs||
0137|091|S|of an infection (such as sore throat that doesn't go away, fever,||
0137|092|S|chills).||
0137|093|S|   A very serious allergic reaction to this drug is rare.||
0137|094|S|However, get medical help right away if you notice any symptoms||
0137|095|S|of a serious allergic reaction, including: rash, itching/swelling||
0137|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0137|097|S|breathing.||
0137|098|S|   This is not a complete list of possible side effects. If you||
0137|099|S|notice other effects not listed above, contact your doctor or||
0137|100|S|pharmacist.||
0137|101|S|   In the US -||
0137|102|S|   Call your doctor for medical advice about side effects. You||
0137|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0137|104|S|www.fda.gov/medwatch.||
0137|105|S|   In Canada - Call your doctor for medical advice about side||
0137|106|S|effects. You may report side effects to Health Canada at||
0137|107|S|1-866-234-2345.||
0137|108|B|||
0137|109|P|PRECAUTIONS:  Before using vinblastine, tell your doctor or||
0137|110|P|pharmacist if you are allergic to it; or if you have any other||
0137|111|P|allergies. This product may contain inactive ingredients, which||
0137|112|P|can cause allergic reactions or other problems. Talk to your||
0137|113|P|pharmacist for more details.||
0137|114|P|   Before using this medication, tell your doctor or pharmacist||
0137|115|P|your medical history, especially: bone marrow problems (such as||
0137|116|P|low white count/platelets from previous chemotherapy/radiation||
0137|117|P|treatment, tumor in the bone marrow), untreated bacterial||
0137|118|P|infections, blood vessel problems (such as blood clots, stroke,||
0137|119|P|Raynaud's disease, varicose veins), heart disease (such as||
0137|120|P|angina, heart attack), poor nutrition, liver disease, lung||
0137|121|P|problems, stomach/intestinal sores (such as peptic ulcer), skin||
0137|122|P|sores (ulcers).||
0137|123|P|   Before having surgery, tell your doctor or dentist about all||
0137|124|P|the products you use (including prescription drugs,||
0137|125|P|nonprescription drugs, and herbal products).||
0137|126|P|   Tell your health care professional that you are using||
0137|127|P|vinblastine before having any immunizations/vaccinations. Avoid||
0137|128|P|contact with people who have recently received live vaccines||
0137|129|P|(such as flu vaccine inhaled through the nose).||
0137|130|P|   To lower your risk of getting cut, bruised, or injured, use||
0137|131|P|caution with sharp objects like razors and nail cutters, and||
0137|132|P|avoid activities such as contact sports.||
0137|133|P|   This medication may make you more sensitive to the sun. Limit||
0137|134|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0137|135|P|sunscreen and wear protective clothing when outdoors. Tell your||
0137|136|P|doctor right away if you get sunburned or have skin||
0137|137|P|blisters/redness.||
0137|138|P|   Older adults (especially if they have poor nutrition or skin||
0137|139|P|sores) may be at greater risk for infections while using this||
0137|140|P|drug.||
0137|141|P|   Tell your doctor if you are pregnant or plan to become||
0137|142|P|pregnant. You should not become pregnant while using vinblastine.||
0137|143|P|Vinblastine may harm an unborn baby. If you become pregnant, talk||
0137|144|P|to your doctor right away about the risks and benefits of this||
0137|145|P|medication.||
0137|146|P|   It is unknown if this drug passes into breast milk. Because of||
0137|147|P|the possible risk to the infant, breastfeeding is not recommended||
0137|148|P|while using this drug. Consult your doctor before breastfeeding.||
0137|149|B|||
0137|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0137|151|I|medications work or increase your risk for serious side effects.||
0137|152|I|This document does not contain all possible drug interactions.||
0137|153|I|Keep a list of all the products you use (including||
0137|154|I|prescription/nonprescription drugs and herbal products) and share||
0137|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
0137|156|I|the dosage of any medicines without your doctor's approval.||
0137|157|I|   Some products that may interact with this drug include:||
0137|158|I|aspirin and other NSAIDs (such as ibuprofen), hydantoins (such as||
0137|159|I|phenytoin), tolterodine, drugs that may harm the ears (for||
0137|160|I|example, cisplatin, carboplatin, aminoglycosides such as||
0137|161|I|gentamicin).||
0137|162|I|   Other medications can affect the removal of vinblastine from||
0137|163|I|your body, which may affect how vinblastine works. Examples||
0137|164|I|include azole antifungals (such as itraconazole, voriconazole),||
0137|165|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
0137|166|I|rifabutin), among others.||
0137|167|I|   Check all prescription and nonprescription medicine labels||
0137|168|I|carefully since many contain pain relievers/fever reducers||
0137|169|I|(NSAIDs such as ibuprofen, naproxen, or aspirin) that may||
0137|170|I|increase your risk of bleeding. However, if your doctor has told||
0137|171|I|you to take low-dose aspirin to prevent heart attack or stroke||
0137|172|I|(usually 81-162 milligrams a day), you should keep taking the||
0137|173|I|aspirin unless your doctor tells you not to. Ask your doctor or||
0137|174|I|pharmacist for more details.||
0137|175|I|   Your doctor may direct you to limit citrus (and other||
0137|176|I|foods/products that increase the acid level of urine) during||
0137|177|I|treatment. Consult your doctor.||
0137|178|B|||
0137|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0137|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0137|181|O|poison control center right away. US residents can call||
0137|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0137|183|O|Symptoms of overdose may include: seizures.||
0137|184|B|||
0137|185|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
0137|186|N|should be done while you are using this medication. Keep all||
0137|187|N|medical and lab appointments. Consult your doctor for more||
0137|188|N|details.||
0137|189|B|||
0137|190|D|MISSED DOSE:  It is important to get each dose of this medication||
0137|191|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0137|192|D|right away for a new dosing schedule.||
0137|193|B|||
0137|194|R|STORAGE:  Consult the product instructions and your pharmacist||
0137|195|R|for storage details. Keep all medications away from children and||
0137|196|R|pets.||
0137|197|R|   Do not flush medications down the toilet or pour them into a||
0137|198|R|drain unless instructed to do so. Properly discard this product||
0137|199|R|when it is expired or no longer needed. Consult your pharmacist||
0137|200|R|or local waste disposal company.||
0137|201|B|||
0137|202|M|MEDICAL ALERT:  Your condition can cause complications in a||
0137|203|M|medical emergency. For information about enrolling in MedicAlert,||
0137|204|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0137|205|B|||
0137|206|A|Information last revised April 2025.||
0137|207|A|Copyright(c) 2025 First Databank, Inc.||
0137|208|B|||
0138|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0138|002|Z|does NOT have all possible information about this product. This||
0138|003|Z|information does not assure that this product is safe, effective,||
0138|004|Z|or appropriate for you. This information is not individual||
0138|005|Z|medical advice and does not substitute for the advice of your||
0138|006|Z|health care professional. Always ask your health care||
0138|007|Z|professional for complete information about this product and your||
0138|008|Z|specific health needs.||
0138|009|B|||
0138|010|T|ZIDOVUDINE (AZT) - ORAL||
0138|011|F|(zye-DOE-vue-deen)||
0138|012|B|||
0138|013|C|COMMON BRAND NAME(S): Retrovir||
0138|014|B|||
0138|015|W|WARNING:  Zidovudine can decrease bone marrow function, which may||
0138|016|W|lead to low numbers of red and white blood cells. A low number of||
0138|017|W|red blood cells can lead to anemia. A low number of white blood||
0138|018|W|cells can decrease your body's ability to fight serious,||
0138|019|W|life-threatening infections. These serious side effects occur||
0138|020|W|more often in people with advanced HIV disease (AIDS). Tell your||
0138|021|W|doctor right away if you develop any signs of anemia (such as||
0138|022|W|unusual tiredness, fast breathing, pale skin, fast heartbeat) or||
0138|023|W|signs of infection (such as sore throat that doesn't go away,||
0138|024|W|fever, chills). Your doctor will check your blood cell counts||
0138|025|W|while you are taking this medication to decrease the risk of||
0138|026|W|these side effects.||
0138|027|W|   This medication may also cause muscle problems (myopathy).||
0138|028|W|Tell your doctor right away if you develop symptoms of myopathy||
0138|029|W|(such as wasting or decrease in muscle size, muscle||
0138|030|W|weakness/pain/tenderness, weight loss).||
0138|031|W|   Rarely, zidovudine has caused severe (sometimes fatal) liver||
0138|032|W|problems and a certain metabolic problem (lactic acidosis). Get||
0138|033|W|medical help right away if you develop symptoms of liver problems||
0138|034|W|(such as nausea that doesn't go away, stomach/abdominal pain,||
0138|035|W|dark urine, yellowing eyes/skin) or lactic acidosis (such as||
0138|036|W|rapid breathing, drowsiness, muscle aches). These serious side||
0138|037|W|effects may occur more often in women and obese patients.||
0138|038|B|||
0138|039|U|USES:  This drug is used with other HIV medications to help||
0138|040|U|control HIV infection. It helps to decrease the amount of HIV in||
0138|041|U|your body so your immune system can work better. This lowers your||
0138|042|U|chance of getting HIV complications (such as new infections,||
0138|043|U|cancer) and improves your quality of life. Zidovudine belongs to||
0138|044|U|a class of drugs known as nucleoside reverse transcriptase||
0138|045|U|inhibitors-NRTIs.||
0138|046|U|   Zidovudine is used in pregnant women to prevent passing the||
0138|047|U|HIV virus to the unborn baby. This medication is also used in||
0138|048|U|newborns born to mothers infected with HIV to prevent infection||
0138|049|U|in the newborns.||
0138|050|U|   Zidovudine is not a cure for HIV infection. To decrease your||
0138|051|U|risk of spreading HIV disease to others, continue to take all HIV||
0138|052|U|medications exactly as prescribed by your doctor. Use an||
0138|053|U|effective barrier method (latex or polyurethane condoms/dental||
0138|054|U|dams) during sexual activity as directed by your doctor. Do not||
0138|055|U|share personal items (such as needles/syringes, toothbrushes, and||
0138|056|U|razors) that may have contacted blood or other body fluids.||
0138|057|U|Consult your doctor or pharmacist for more details.||
0138|058|B|||
0138|059|V|OTHER USES:  This section contains uses of this drug that are not||
0138|060|V|listed in the approved professional labeling for the drug but||
0138|061|V|that may be prescribed by your health care professional. Use this||
0138|062|V|drug for a condition that is listed in this section only if it||
0138|063|V|has been so prescribed by your health care professional.||
0138|064|V|   This product may also be used to lessen the risk of HIV||
0138|065|V|infection after contact with the virus (for example, due to a||
0138|066|V|needle stick). Ask your doctor for more details.||
0138|067|B|||
0138|068|H|HOW TO USE:  Take this medication by mouth with or without food||
0138|069|H|as directed by your doctor, usually 2 to 3 times daily. Take this||
0138|070|H|medication with a full glass of water (8 ounces/240 milliliters)||
0138|071|H|unless your doctor directs you otherwise. If you are using the||
0138|072|H|liquid form of this medication, carefully measure the dose using||
0138|073|H|a special measuring device/spoon. Do not use a household spoon||
0138|074|H|because you may not get the correct dose.||
0138|075|H|   The dosage is based on your medical condition and response to||
0138|076|H|treatment. Children's dosage is also based on weight. Pregnant||
0138|077|H|women may need to take this medication 5 times a day. Newborns||
0138|078|H|are usually given the liquid form every 6 hours for 6 weeks after||
0138|079|H|birth to prevent infection.||
0138|080|H|   Take this medication 2 hours before or after taking||
0138|081|H|clarithromycin. Clarithromycin may prevent your body from fully||
0138|082|H|absorbing zidovudine.||
0138|083|H|   For the best effect, take this medication at evenly spaced||
0138|084|H|times. To help you remember, take this medication at the same||
0138|085|H|times every day.||
0138|086|H|   It is very important to keep taking this medication (and other||
0138|087|H|HIV medications) exactly as prescribed by your doctor. Do not||
0138|088|H|skip any doses. Refill your medication before you run out.||
0138|089|H|   Do not take more or less of this drug than prescribed or stop||
0138|090|H|taking it (or other HIV medicines) even for a short time unless||
0138|091|H|directed to do so by your doctor. Skipping or changing your dose||
0138|092|H|without approval from your doctor may cause the amount of virus||
0138|093|H|to increase, make the infection more difficult to treat||
0138|094|H|(resistant), or worsen side effects.||
0138|095|B|||
0138|096|S|SIDE EFFECTS:  See also Warning section.||
0138|097|S|   Headache, nausea, vomiting, trouble sleeping, or loss of||
0138|098|S|appetite may occur. If any of these effects last or get worse,||
0138|099|S|notify your doctor or pharmacist promptly.||
0138|100|S|   Remember that this medication has been prescribed because your||
0138|101|S|doctor has judged that the benefit to you is greater than the||
0138|102|S|risk of side effects. Many people using this medication do not||
0138|103|S|have serious side effects.||
0138|104|S|   As your immune system gets stronger, it can begin to fight off||
0138|105|S|infections you already had, possibly causing disease symptoms to||
0138|106|S|come back. You could also have symptoms if your immune system||
0138|107|S|becomes overactive. This reaction may happen at any time (soon||
0138|108|S|after starting HIV treatment or many months later). Tell your||
0138|109|S|doctor right away if you have any serious symptoms, including:||
0138|110|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
0138|111|S|that doesn't go away, headaches that are severe or don't go away,||
0138|112|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
0138|113|S|changes, signs of infection (such as sore throat that doesn't go||
0138|114|S|away, fever, chills, swollen lymph nodes, non-healing skin||
0138|115|S|sores), signs of an overactive thyroid (such as irritability,||
0138|116|S|nervousness, heat intolerance, fast/pounding/irregular||
0138|117|S|heartbeat).||
0138|118|S|   Tell your doctor right away if you have any serious side||
0138|119|S|effects, including: mental/mood changes (such as depression,||
0138|120|S|anxiety, confusion), easy bruising/bleeding, skin/fingernail||
0138|121|S|color changes.||
0138|122|S|   Get medical help right away if you have any very serious side||
0138|123|S|effects, including: seizures.||
0138|124|S|   Loss of body fat (such as in the face, arms, legs, and||
0138|125|S|buttocks) may occur while you are taking this medication. This||
0138|126|S|effect may be permanent. Tell your doctor right away if you||
0138|127|S|notice any changes in body fat.||
0138|128|S|   A very serious allergic reaction to this drug is rare.||
0138|129|S|However, get medical help right away if you notice any symptoms||
0138|130|S|of a serious allergic reaction, including: rash, itching/swelling||
0138|131|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0138|132|S|breathing.||
0138|133|S|   This is not a complete list of possible side effects. If you||
0138|134|S|notice other effects not listed above, contact your doctor or||
0138|135|S|pharmacist.||
0138|136|S|   In the US -||
0138|137|S|   Call your doctor for medical advice about side effects. You||
0138|138|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0138|139|S|www.fda.gov/medwatch.||
0138|140|S|   In Canada - Call your doctor for medical advice about side||
0138|141|S|effects. You may report side effects to Health Canada at||
0138|142|S|1-866-234-2345.||
0138|143|B|||
0138|144|P|PRECAUTIONS:  Before taking zidovudine, tell your doctor or||
0138|145|P|pharmacist if you are allergic to it; or if you have any other||
0138|146|P|allergies. This product may contain inactive ingredients, which||
0138|147|P|can cause allergic reactions or other problems. Talk to your||
0138|148|P|pharmacist for more details.||
0138|149|P|   Before using this medication, tell your doctor or pharmacist||
0138|150|P|your medical history, especially of: kidney problems, liver||
0138|151|P|problems (such as hepatitis B or C, cirrhosis), alcohol use, low||
0138|152|P|red/white blood cells.||
0138|153|P|   Liquid products may contain sugar. Caution is advised if you||
0138|154|P|have diabetes or any other condition that requires you to limit||
0138|155|P|sugar in your diet. Ask your doctor or pharmacist about using||
0138|156|P|this product safely.||
0138|157|P|   Before having surgery, tell your doctors or dentist about all||
0138|158|P|the products you use (including prescription drugs,||
0138|159|P|nonprescription drugs, and herbal products).||
0138|160|P|   Tell your doctor if you are pregnant before using this||
0138|161|P|medication. Treatment can lower the risk of passing HIV infection||
0138|162|P|to your baby. Discuss the risks and benefits with your doctor.||
0138|163|P|   This medication passes into breast milk. Because breast milk||
0138|164|P|may transmit HIV, consult your doctor before breastfeeding.||
0138|165|B|||
0138|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0138|167|I|medications work or increase your risk for serious side effects.||
0138|168|I|This document does not contain all possible drug interactions.||
0138|169|I|Keep a list of all the products you use (including||
0138|170|I|prescription/nonprescription drugs and herbal products) and share||
0138|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
0138|172|I|the dosage of any medicines without your doctor's approval.||
0138|173|I|   Some products that may interact with this drug include:||
0138|174|I|orlistat, ribavirin, stavudine, drugs that may suppress bone||
0138|175|I|marrow function (such as ganciclovir, dapsone, trimethoprim,||
0138|176|I|chemotherapy including doxorubicin, vincristine).||
0138|177|I|   Other medications can affect the removal of zidovudine from||
0138|178|I|your body, which may affect how zidovudine works. Examples||
0138|179|I|include methadone, rifampin, drugs used to treat seizures (such||
0138|180|I|as phenytoin, valproic acid), among others.||
0138|181|I|   This medication must not be taken with other medications that||
0138|182|I|contain zidovudine. Check the labels on all your other||
0138|183|I|prescription medications to make sure they do not contain||
0138|184|I|zidovudine. If you have any questions, consult your doctor or||
0138|185|I|pharmacist.||
0138|186|B|||
0138|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0138|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0138|189|O|poison control center right away. US residents can call||
0138|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0138|191|O|Symptoms of overdose may include extreme drowsiness/tiredness,||
0138|192|O|confusion, seizures.||
0138|193|B|||
0138|194|N|NOTES:  Do not share this medication with others.||
0138|195|N|   Lab and/or medical tests (such as blood counts, liver tests,||
0138|196|N|viral load, T-cell counts) should be done while you are taking||
0138|197|N|this medication. Keep all medical and lab appointments. Consult||
0138|198|N|your doctor for more details.||
0138|199|B|||
0138|200|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0138|201|D|remember. If it is near the time of the next dose, skip the||
0138|202|D|missed dose. Take your next dose at the regular time. Do not||
0138|203|D|double the dose to catch up.||
0138|204|B|||
0138|205|R|STORAGE:  Store at room temperature away from light and moisture.||
0138|206|R|Do not store in the bathroom. Keep all medications away from||
0138|207|R|children and pets.||
0138|208|R|   Do not flush medications down the toilet or pour them into a||
0138|209|R|drain unless instructed to do so. Properly discard this product||
0138|210|R|when it is expired or no longer needed. Consult your pharmacist||
0138|211|R|or local waste disposal company.||
0138|212|B|||
0138|213|A|Information last revised August 2025.||
0138|214|A|Copyright(c) 2025 First Databank, Inc.||
0138|215|B|||
0139|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0139|002|Z|does NOT have all possible information about this product. This||
0139|003|Z|information does not assure that this product is safe, effective,||
0139|004|Z|or appropriate for you. This information is not individual||
0139|005|Z|medical advice and does not substitute for the advice of your||
0139|006|Z|health care professional. Always ask your health care||
0139|007|Z|professional for complete information about this product and your||
0139|008|Z|specific health needs.||
0139|009|B|||
0139|010|T|CALCIUM SUPPLEMENTS - ORAL||
0139|011|B|||
0139|012|U|USES:  This medication is used to prevent or treat low blood||
0139|013|U|calcium levels in people who do not get enough calcium from their||
0139|014|U|diets. It may be used to treat conditions caused by low calcium||
0139|015|U|levels such as bone loss (osteoporosis), weak bones||
0139|016|U|(osteomalacia/rickets), decreased activity of the parathyroid||
0139|017|U|gland (hypoparathyroidism), and a certain muscle disease (latent||
0139|018|U|tetany). It may also be used in certain patients to make sure||
0139|019|U|they are getting enough calcium (such as women who are pregnant,||
0139|020|U|nursing, or postmenopausal, people taking certain medications||
0139|021|U|such as phenytoin, phenobarbital, or prednisone).||
0139|022|U|   Calcium plays a very important role in the body. It is||
0139|023|U|necessary for normal functioning of nerves, cells, muscle, and||
0139|024|U|bone. If there is not enough calcium in the blood, then the body||
0139|025|U|will take calcium from bones, thereby weakening bones. Having the||
0139|026|U|right amount of calcium is important for building and keeping||
0139|027|U|strong bones.||
0139|028|B|||
0139|029|H|HOW TO USE:  Take this medication by mouth with food. If your||
0139|030|H|product contains calcium citrate, then it may be taken with or||
0139|031|H|without food. Follow all directions on the product package, or||
0139|032|H|take as directed by your doctor. For best absorption, if your||
0139|033|H|daily dose is more than 600 milligrams, then divide your dose and||
0139|034|H|space it throughout the day. If you have any questions, ask your||
0139|035|H|doctor or pharmacist.||
0139|036|H|   If you are using the chewable product, chew it well before||
0139|037|H|swallowing.||
0139|038|H|   If you are using the effervescent tablet, allow the tablet to||
0139|039|H|fully dissolve in a glass of water before drinking it. Do not||
0139|040|H|chew or swallow the tablet whole.||
0139|041|H|   If you are using the liquid product or powder, measure the||
0139|042|H|medication with a dose-measuring spoon or device to make sure you||
0139|043|H|get the correct dose. Do not use a household spoon. If the liquid||
0139|044|H|product is a suspension, shake the bottle well before each dose.||
0139|045|H|   Use this medication regularly to get the most benefit from it.||
0139|046|H|To help you remember, take it at the same time(s) each day.||
0139|047|H|   If your doctor has recommended that you follow a special diet,||
0139|048|H|it is very important to follow the diet to get the most benefit||
0139|049|H|from this medication and to prevent serious side effects. Do not||
0139|050|H|take other supplements/vitamins unless ordered by your doctor.||
0139|051|H|   If you think you may have a serious medical problem, get||
0139|052|H|medical help right away.||
0139|053|B|||
0139|054|S|SIDE EFFECTS:  Constipation and upset stomach may occur. If any||
0139|055|S|of these effects last or get worse, tell your doctor or||
0139|056|S|pharmacist promptly.||
0139|057|S|   If your doctor has directed you to use this medication,||
0139|058|S|remember that your doctor has judged that the benefit to you is||
0139|059|S|greater than the risk of side effects. Many people using this||
0139|060|S|medication do not have serious side effects.||
0139|061|S|   Tell your doctor right away if you have any serious side||
0139|062|S|effects, including: nausea/vomiting, loss of appetite, unusual||
0139|063|S|weight loss, mental/mood changes, bone/muscle pain, headache,||
0139|064|S|increased thirst/urination, weakness, unusual tiredness.||
0139|065|S|   A very serious allergic reaction to this drug is rare.||
0139|066|S|However, get medical help right away if you notice any symptoms||
0139|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0139|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0139|069|S|breathing.||
0139|070|S|   This is not a complete list of possible side effects. If you||
0139|071|S|notice other effects not listed above, contact your doctor or||
0139|072|S|pharmacist.||
0139|073|S|   In the US -||
0139|074|S|   Call your doctor for medical advice about side effects. You||
0139|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0139|076|S|www.fda.gov/medwatch.||
0139|077|S|   In Canada - Call your doctor for medical advice about side||
0139|078|S|effects. You may report side effects to Health Canada at||
0139|079|S|1-866-234-2345.||
0139|080|B|||
0139|081|P|PRECAUTIONS:  Before taking calcium, tell your doctor or||
0139|082|P|pharmacist if you have any allergies. This product may contain||
0139|083|P|inactive ingredients, which can cause allergic reactions or other||
0139|084|P|problems. Talk to your pharmacist for more details.||
0139|085|P|   If you have any of the following health problems, consult your||
0139|086|P|doctor or pharmacist before using this product: high calcium||
0139|087|P|levels (hypercalcemia), kidney disease (including kidney stones),||
0139|088|P|little or no stomach acid (achlorhydria), heart disease, disease||
0139|089|P|of the pancreas, a certain lung disease (sarcoidosis), difficulty||
0139|090|P|absorbing nutrition from food (malabsorption syndrome).||
0139|091|P|   Some sugar-free formulations of calcium may contain aspartame.||
0139|092|P|If you have phenylketonuria (PKU) or any other condition that||
0139|093|P|requires you to restrict your intake of aspartame (or||
0139|094|P|phenylalanine), consult your doctor or pharmacist about using||
0139|095|P|this drug safely.||
0139|096|P|   Before having surgery, tell your doctor or dentist about all||
0139|097|P|the products you use (including prescription drugs,||
0139|098|P|nonprescription drugs, and herbal products).||
0139|099|P|   Tell your doctor if you are pregnant before using this||
0139|100|P|medication.||
0139|101|P|   This medication passes into breast milk. Consult your doctor||
0139|102|P|before breastfeeding.||
0139|103|B|||
0139|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0139|105|I|medications work or increase your risk for serious side effects.||
0139|106|I|This document does not contain all possible drug interactions.||
0139|107|I|Keep a list of all the products you use (including||
0139|108|I|prescription/nonprescription drugs and herbal products) and share||
0139|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
0139|110|I|the dosage of any medicines without your doctor's approval.||
0139|111|I|   This product can decrease the absorption of certain drugs,||
0139|112|I|especially if you take them around the same time. These drugs||
0139|113|I|include bisphosphonates (such as alendronate), penicillamine,||
0139|114|I|quinolone antibiotics (such as ciprofloxacin, levofloxacin),||
0139|115|I|tetracycline antibiotics (such as doxycycline, minocycline),||
0139|116|I|thyroid medications (such as levothyroxine), among others. Ask||
0139|117|I|your doctor or pharmacist how long you should wait between doses||
0139|118|I|of this product and your other medications and to find a dosing||
0139|119|I|schedule that works for all your medications.||
0139|120|I|   Check the labels on all your prescription and||
0139|121|I|nonprescription/herbal products (such as antacids, vitamins)||
0139|122|I|because they may contain calcium. Ask your pharmacist about using||
0139|123|I|those products safely.||
0139|124|B|||
0139|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0139|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0139|127|O|poison control center right away. US residents can call||
0139|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0139|129|O|Symptoms of overdose may include: nausea/vomiting, loss of||
0139|130|O|appetite, mental/mood changes, headache, weakness, tiredness.||
0139|131|B|||
0139|132|N|NOTES:  Foods rich in calcium include: dairy products (such as||
0139|133|N|milk, yogurt, cheese, ice cream), dark-green leafy vegetables||
0139|134|N|(such as broccoli, spinach, bok choy), and calcium-fortified||
0139|135|N|foods (such as orange juice).||
0139|136|N|   Vitamin D helps with the absorption of calcium. Foods rich in||
0139|137|N|vitamin D include: fortified dairy products, eggs, sardines, cod||
0139|138|N|liver oil, chicken livers, and fatty fish. Vitamin D is also made||
0139|139|N|by the body as a result of exposure to the sun.||
0139|140|N|   Lab and/or medical tests (such as calcium levels) may be done||
0139|141|N|while you are taking this medication. Keep all medical and lab||
0139|142|N|appointments. Consult your doctor for more details.||
0139|143|B|||
0139|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0139|145|D|remember. If it is near the time of the next dose, skip the||
0139|146|D|missed dose. Take your next dose at the regular time. Do not||
0139|147|D|double the dose to catch up.||
0139|148|B|||
0139|149|R|STORAGE:  Store at room temperature away from light and moisture.||
0139|150|R|Do not store in the bathroom. Keep all medications away from||
0139|151|R|children and pets.||
0139|152|R|   Do not flush medications down the toilet or pour them into a||
0139|153|R|drain unless instructed to do so. Properly discard this product||
0139|154|R|when it is expired or no longer needed. Consult your pharmacist||
0139|155|R|or local waste disposal company.||
0139|156|B|||
0139|157|A|Information last revised October 2025.||
0139|158|A|Copyright(c) 2025 First Databank, Inc.||
0139|159|B|||
0140|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0140|002|Z|does NOT have all possible information about this product. This||
0140|003|Z|information does not assure that this product is safe, effective,||
0140|004|Z|or appropriate for you. This information is not individual||
0140|005|Z|medical advice and does not substitute for the advice of your||
0140|006|Z|health care professional. Always ask your health care||
0140|007|Z|professional for complete information about this product and your||
0140|008|Z|specific health needs.||
0140|009|B|||
0140|010|T|BUSPIRONE - ORAL||
0140|011|F|(bue-SPYE-rone)||
0140|012|B|||
0140|013|C|COMMON BRAND NAME(S): Bucapsol, Buspar||
0140|014|B|||
0140|015|U|USES:  This medication is used to treat anxiety. It works by||
0140|016|U|helping to restore the balance of certain natural substances in||
0140|017|U|the brain.||
0140|018|B|||
0140|019|H|HOW TO USE:  Take this medication by mouth as directed by your||
0140|020|H|doctor, usually 2 or 3 times a day. You may take this medication||
0140|021|H|with or without food, but it is important to choose one way and||
0140|022|H|always take it the same way so that the amount of drug absorbed||
0140|023|H|will always be the same.||
0140|024|H|   If you are using the tablet form, buspirone may come in a||
0140|025|H|tablet that can be split to get the correct dose for you. Follow||
0140|026|H|the manufacturer's Patient Instruction Sheet or ask your||
0140|027|H|pharmacist how to split the tablet to get your dose.||
0140|028|H|   If you are using the capsule form and have trouble swallowing||
0140|029|H|the capsules, the capsule may be opened and the contents||
0140|030|H|sprinkled on about 1 to 2 tablespoons (15 to 30 milliliters) of||
0140|031|H|applesauce and swallowed right away.||
0140|032|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0140|033|H|using this medication unless your doctor or pharmacist says you||
0140|034|H|may do so safely. Grapefruit can increase the chance of side||
0140|035|H|effects with this medicine. Ask your doctor or pharmacist for||
0140|036|H|more details.||
0140|037|H|   The dosage is based on your medical condition and response to||
0140|038|H|treatment. Use this medication regularly in order to get the most||
0140|039|H|benefit from it. To help you remember, use it at the same times||
0140|040|H|each day. When this medication is started, symptoms of anxiety||
0140|041|H|(such as restlessness) may sometimes get worse before they get||
0140|042|H|better. It may take up to a month or more to get the full effect||
0140|043|H|of this medication.||
0140|044|H|   Tell your doctor if your symptoms last or get worse.||
0140|045|B|||
0140|046|S|SIDE EFFECTS:  Dizziness, drowsiness, headache, nausea,||
0140|047|S|nervousness, lightheadedness, restlessness, blurred vision,||
0140|048|S|tiredness, and trouble sleeping may occur. If any of these||
0140|049|S|effects last or get worse, tell your doctor or pharmacist||
0140|050|S|promptly.||
0140|051|S|   Remember that this medication has been prescribed because your||
0140|052|S|doctor has judged that the benefit to you is greater than the||
0140|053|S|risk of side effects. Many people using this medication do not||
0140|054|S|have serious side effects.||
0140|055|S|   Rarely, patients taking buspirone may develop movement||
0140|056|S|disorders such as shakiness (tremors), muscle stiffness,||
0140|057|S|mask-like facial expression, jerky walking movements, or a||
0140|058|S|condition known as tardive dyskinesia. In some cases, these||
0140|059|S|conditions may be permanent. Tell your doctor right away if you||
0140|060|S|develop any unusual/uncontrolled movements (especially of the||
0140|061|S|face, mouth, tongue, arms, or legs).||
0140|062|S|   Get medical help right away if you have any very serious side||
0140|063|S|effects, including: easy bleeding/bruising, shortness of breath,||
0140|064|S|chest pain, fast/irregular heartbeat.||
0140|065|S|   A very serious allergic reaction to this drug is rare.||
0140|066|S|However, get medical help right away if you notice any symptoms||
0140|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0140|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0140|069|S|breathing.||
0140|070|S|   This is not a complete list of possible side effects. If you||
0140|071|S|notice other effects not listed above, contact your doctor or||
0140|072|S|pharmacist .||
0140|073|S|   In the US -||
0140|074|S|   Call your doctor for medical advice about side effects. You||
0140|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0140|076|S|www.fda.gov/medwatch.||
0140|077|S|   In Canada - Call your doctor for medical advice about side||
0140|078|S|effects. You may report side effects to Health Canada at||
0140|079|S|1-866-234-2345.||
0140|080|B|||
0140|081|P|PRECAUTIONS:  Before taking buspirone, tell your doctor or||
0140|082|P|pharmacist if you are allergic to it; or if you have any other||
0140|083|P|allergies. This product may contain inactive ingredients, which||
0140|084|P|can cause allergic reactions or other problems. Talk to your||
0140|085|P|pharmacist for more details.||
0140|086|P|   Before using this medication, tell your doctor or pharmacist||
0140|087|P|your medical history, especially of: kidney problems, liver||
0140|088|P|problems, bipolar disorder (manic-depression), Parkinson's||
0140|089|P|disease.||
0140|090|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0140|091|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0140|092|P|machinery, or do anything that needs alertness until you can do||
0140|093|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0140|094|P|are using marijuana (cannabis).||
0140|095|P|   Before having surgery, tell your doctor or dentist about all||
0140|096|P|the products you use (including prescription drugs,||
0140|097|P|nonprescription drugs, and herbal products).||
0140|098|P|   During pregnancy, this medication should only be used when||
0140|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
0140|100|P|   This medication passes into breast milk. Consult your doctor||
0140|101|P|before breastfeeding.||
0140|102|B|||
0140|103|I|DRUG INTERACTIONS:  See also How to Use section.||
0140|104|I|   Drug interactions may change how your medications work or||
0140|105|I|increase your risk for serious side effects. This document does||
0140|106|I|not contain all possible drug interactions. Keep a list of all||
0140|107|I|the products you use (including prescription/nonprescription||
0140|108|I|drugs and herbal products) and share it with your doctor and||
0140|109|I|pharmacist. Do not start, stop, or change the dosage of any||
0140|110|I|medicines without your doctor's approval.||
0140|111|I|   Some products that may interact with this drug are:||
0140|112|I|antidepressants (including SSRIs such as fluoxetine, tricyclic||
0140|113|I|antidepressants such as amitriptyline/nortriptyline, trazodone),||
0140|114|I|haloperidol.||
0140|115|I|   Taking MAO inhibitors with this medication may cause a serious||
0140|116|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0140|117|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0140|118|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0140|119|I|selegiline, tranylcypromine) during treatment with this||
0140|120|I|medication. Most MAO inhibitors should also not be taken for two||
0140|121|I|weeks before and after treatment with this medication. Ask your||
0140|122|I|doctor when to start or stop taking this medication.||
0140|123|I|   Other medications can affect the removal of buspirone from||
0140|124|I|your body, which may affect how buspirone works. Examples include||
0140|125|I|azole antifungals (such as itraconazole), corticosteroids (such||
0140|126|I|as dexamethasone), diltiazem, nefazodone, rifamycins (such as||
0140|127|I|rifabutin), ritonavir, drugs used to treat seizures (such as||
0140|128|I|phenytoin, phenobarbital), among others.||
0140|129|I|   Tell your doctor or pharmacist if you are taking other||
0140|130|I|products that cause drowsiness such as opioid pain or cough||
0140|131|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0140|132|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0140|133|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0140|134|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0140|135|I|diphenhydramine).||
0140|136|I|   Check the labels on all your medicines (such as allergy or||
0140|137|I|cough-and-cold products) because they may contain ingredients||
0140|138|I|that cause drowsiness. Ask your pharmacist about using those||
0140|139|I|products safely.||
0140|140|I|   This medication may interfere with certain medical/lab tests||
0140|141|I|(such as brain scan for Parkinson's disease), possibly causing||
0140|142|I|false test results. Make sure lab personnel and all your doctors||
0140|143|I|know you use this drug.||
0140|144|B|||
0140|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0140|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0140|147|O|poison control center right away. US residents can call||
0140|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0140|149|B|||
0140|150|N|NOTES:  Do not share this medication with others.||
0140|151|N|   Keep all medical and lab appointments.||
0140|152|B|||
0140|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0140|154|D|remember. If it is near the time of the next dose, skip the||
0140|155|D|missed dose. Take your next dose at the regular time. Do not||
0140|156|D|double the dose to catch up.||
0140|157|B|||
0140|158|R|STORAGE:  Store at room temperature away from light and moisture.||
0140|159|R|Do not store in the bathroom. Keep all medications away from||
0140|160|R|children and pets.||
0140|161|R|   Do not flush medications down the toilet or pour them into a||
0140|162|R|drain unless instructed to do so. Properly discard this product||
0140|163|R|when it is expired or no longer needed. Consult your pharmacist||
0140|164|R|or local waste disposal company.||
0140|165|B|||
0140|166|A|Information last revised May 2025.||
0140|167|A|Copyright(c) 2025 First Databank, Inc.||
0140|168|B|||
0141|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0141|002|Z|does NOT have all possible information about this product. This||
0141|003|Z|information does not assure that this product is safe, effective,||
0141|004|Z|or appropriate for you. This information is not individual||
0141|005|Z|medical advice and does not substitute for the advice of your||
0141|006|Z|health care professional. Always ask your health care||
0141|007|Z|professional for complete information about this product and your||
0141|008|Z|specific health needs.||
0141|009|B|||
0141|010|T|GENTAMICIN - INJECTION||
0141|011|F|(JEN-ta-MYE-sin)||
0141|012|B|||
0141|013|C|COMMON BRAND NAME(S): Garamycin||
0141|014|B|||
0141|015|W|WARNING:  This medication can cause serious kidney problems and||
0141|016|W|nerve damage, resulting in permanent hearing loss (including||
0141|017|W|deafness or decreased hearing) and balance problems. The risk is||
0141|018|W|increased if you are older, already have kidney disease, or if||
0141|019|W|you have a severe loss of body water (dehydration). Your risk is||
0141|020|W|also increased if you receive high doses, or with longer use of||
0141|021|W|this medication.||
0141|022|W|   Tell your doctor right away if you notice ringing/roaring||
0141|023|W|sounds in the ears, hearing loss, dizziness, or an unusual||
0141|024|W|decrease in the amount of your urine.||
0141|025|W|   Careful monitoring by your doctor will reduce the risk of||
0141|026|W|these side effects. Monitoring may include hearing, kidney,||
0141|027|W|urine, and drug blood level tests.||
0141|028|W|   Avoid other medications that may increase your risk for these||
0141|029|W|serious side effects if taken together with gentamicin. See also||
0141|030|W|Drug Interactions section.||
0141|031|B|||
0141|032|U|USES:  This medication is used to prevent or treat a wide variety||
0141|033|U|of bacterial infections. Gentamicin belongs to a class of drugs||
0141|034|U|known as aminoglycoside antibiotics. It works by stopping the||
0141|035|U|growth of bacteria.||
0141|036|B|||
0141|037|H|HOW TO USE:  This medication is given by injection into a vein or||
0141|038|H|muscle as directed by your doctor, usually every 8 hours. The||
0141|039|H|dosage is based on your medical condition, weight, lab tests, and||
0141|040|H|response to treatment.||
0141|041|H|   If you are giving this medication to yourself at home, learn||
0141|042|H|all preparation and usage instructions from your health care||
0141|043|H|professional. Before using, check this product for particles or||
0141|044|H|discoloration. If either is present, do not use the liquid. Learn||
0141|045|H|how to store and discard medical supplies safely.||
0141|046|H|   For the best effect, use this antibiotic at evenly spaced||
0141|047|H|times. To help you remember, use this medication at the same||
0141|048|H|time(s) every day.||
0141|049|H|   Continue to use this medication until the full prescribed||
0141|050|H|amount is finished, even if symptoms disappear after a few days.||
0141|051|H|Stopping the medication too early may result in a return of the||
0141|052|H|infection.||
0141|053|H|   Tell your doctor if your condition lasts or gets worse.||
0141|054|B|||
0141|055|S|SIDE EFFECTS:  See also Warning section.||
0141|056|S|   Nausea, vomiting, stomach upset, or loss of appetite may||
0141|057|S|occur. Pain/irritation/redness at the injection site may rarely||
0141|058|S|occur. If any of these effects last or get worse, tell your||
0141|059|S|doctor or pharmacist promptly.||
0141|060|S|   Remember that this medication has been prescribed because your||
0141|061|S|doctor has judged that the benefit to you is greater than the||
0141|062|S|risk of side effects. Many people using this medication do not||
0141|063|S|have serious side effects.||
0141|064|S|   Tell your doctor right away if you have any serious side||
0141|065|S|effects, including: numbness/tingling, muscle twitching or||
0141|066|S|weakness, seizure.||
0141|067|S|   This medication may rarely cause a severe intestinal condition||
0141|068|S|due to a bacteria called C. difficile. This condition may occur||
0141|069|S|during treatment or weeks to months after treatment has stopped.||
0141|070|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0141|071|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0141|072|S|stool.||
0141|073|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0141|074|S|products because they may make symptoms worse.||
0141|075|S|   Use of this medication for prolonged or repeated periods may||
0141|076|S|result in oral thrush or a new yeast infection. Contact your||
0141|077|S|doctor if you notice white patches in your mouth, a change in||
0141|078|S|vaginal discharge, or other new symptoms.||
0141|079|S|   A very serious allergic reaction to this drug is rare.||
0141|080|S|However, get medical help right away if you notice any symptoms||
0141|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0141|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0141|083|S|breathing.||
0141|084|S|   This is not a complete list of possible side effects. If you||
0141|085|S|notice other effects not listed above, contact your doctor or||
0141|086|S|pharmacist.||
0141|087|S|   In the US -||
0141|088|S|   Call your doctor for medical advice about side effects. You||
0141|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0141|090|S|www.fda.gov/medwatch.||
0141|091|S|   In Canada - Call your doctor for medical advice about side||
0141|092|S|effects. You may report side effects to Health Canada at||
0141|093|S|1-866-234-2345.||
0141|094|B|||
0141|095|P|PRECAUTIONS:  Before using gentamicin, tell your doctor or||
0141|096|P|pharmacist if you are allergic to it; or to other aminoglycoside||
0141|097|P|antibiotics (such as tobramycin, amikacin); or if you have any||
0141|098|P|other allergies. This product may contain inactive ingredients||
0141|099|P|(such as sulfites), which can cause allergic reactions or other||
0141|100|P|problems. Talk to your pharmacist for more details.||
0141|101|P|   Before using this medication, tell your doctor or pharmacist||
0141|102|P|your medical history, especially of: cystic fibrosis, hearing||
0141|103|P|problems (including deafness, decreased hearing), kidney||
0141|104|P|problems, low blood minerals (including potassium, magnesium,||
0141|105|P|calcium), myasthenia gravis, Parkinson's disease.||
0141|106|P|   Gentamicin may cause live bacterial vaccines (such as typhoid||
0141|107|P|vaccine) to not work well. Tell your health care professional||
0141|108|P|that you are using gentamicin before having any||
0141|109|P|immunizations/vaccinations.||
0141|110|P|   Before having surgery, tell your doctor or dentist about all||
0141|111|P|the products you use (including prescription drugs,||
0141|112|P|nonprescription drugs, and herbal products).||
0141|113|P|   Older adults may be more sensitive to the effects of this||
0141|114|P|drug, especially kidney damage.||
0141|115|P|   This medication is not recommended for use during pregnancy.||
0141|116|P|Although there have been reports of harm in babies born to women||
0141|117|P|using similar drugs, the risk for harm may not be the same with||
0141|118|P|this drug. Discuss the risks and benefits with your doctor.||
0141|119|P|   This drug passes into breast milk in small amounts. However,||
0141|120|P|many doctors consider breastfeeding safe while using this||
0141|121|P|medication. Consult your doctor before breastfeeding.||
0141|122|B|||
0141|123|I|DRUG INTERACTIONS:  See also Warning section.||
0141|124|I|   Drug interactions may change how your medications work or||
0141|125|I|increase your risk for serious side effects. This document does||
0141|126|I|not contain all possible drug interactions. Keep a list of all||
0141|127|I|the products you use (including prescription/nonprescription||
0141|128|I|drugs and herbal products) and share it with your doctor and||
0141|129|I|pharmacist. Do not start, stop, or change the dosage of any||
0141|130|I|medicines without your doctor's approval.||
0141|131|I|   Other medications that may affect the kidneys or hearing may||
0141|132|I|increase the risk of kidney damage or hearing loss if taken with||
0141|133|I|gentamicin. Some affected drugs include: amikacin, tobramycin,||
0141|134|I|amphotericin B, cidofovir, cisplatin, polymyxin B, cephalosporins||
0141|135|I|such as cephaloridine, nonsteroidal anti-inflammatory drugs||
0141|136|I|(NSAIDs) such as ibuprofen, among others.||
0141|137|B|||
0141|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0141|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0141|140|O|poison control center right away. US residents can call||
0141|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0141|142|B|||
0141|143|N|NOTES:  Lab and/or medical tests (such as kidney function, levels||
0141|144|N|of drug in your blood) may be done while you are using this||
0141|145|N|medication. Keep all medical and lab appointments. Consult your||
0141|146|N|doctor for more details.||
0141|147|B|||
0141|148|D|MISSED DOSE:  It is important to get each dose of this medication||
0141|149|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0141|150|D|right away for a new dosing schedule. Do not double the dose to||
0141|151|D|catch up.||
0141|152|B|||
0141|153|R|STORAGE:  Consult the product instructions and your pharmacist||
0141|154|R|for storage details. Keep all medications away from children and||
0141|155|R|pets.||
0141|156|R|   Do not flush medications down the toilet or pour them into a||
0141|157|R|drain unless instructed to do so. Properly discard this product||
0141|158|R|when it is expired or no longer needed. Consult your pharmacist||
0141|159|R|or local waste disposal company.||
0141|160|B|||
0141|161|A|Information last revised November 2024.||
0141|162|A|Copyright(c) 2025 First Databank, Inc.||
0141|163|B|||
0142|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0142|002|Z|does NOT have all possible information about this product. This||
0142|003|Z|information does not assure that this product is safe, effective,||
0142|004|Z|or appropriate for you. This information is not individual||
0142|005|Z|medical advice and does not substitute for the advice of your||
0142|006|Z|health care professional. Always ask your health care||
0142|007|Z|professional for complete information about this product and your||
0142|008|Z|specific health needs.||
0142|009|B|||
0142|010|T|DIGESTIVE ENZYMES - ORAL||
0142|011|B|||
0142|012|U|USES:  This medication contains digestive enzymes, which are||
0142|013|U|natural substances needed by the body to help break down and||
0142|014|U|digest food. It is used when the pancreas cannot make or does not||
0142|015|U|release enough digestive enzymes into the gut to digest the food.||
0142|016|U|Depending on the amount of enzymes in your product, it may be||
0142|017|U|used for indigestion, as a supplement, or as replacement therapy||
0142|018|U|(such as in chronic pancreatitis, cystic fibrosis, cancer of the||
0142|019|U|pancreas, after surgery on the pancreas or gut).||
0142|020|U|   Some supplement products have been found to contain possibly||
0142|021|U|harmful impurities/additives. Check with your pharmacist for more||
0142|022|U|details about the brand you use.||
0142|023|U|   The FDA has not reviewed this product for safety or||
0142|024|U|effectiveness. Consult your doctor or pharmacist for more||
0142|025|U|details.||
0142|026|B|||
0142|027|H|HOW TO USE:  Take this medication by mouth with meals and snacks||
0142|028|H|as directed by your doctor.||
0142|029|H|   The dosage is based on your medical condition, diet, and||
0142|030|H|response to treatment.||
0142|031|H|   If you are using the tablet form of the medication, make sure||
0142|032|H|not to keep it in the mouth because doing so can cause irritation||
0142|033|H|to the gums and cheeks. Swallow the medication with water. For||
0142|034|H|the chewable tablets, chew thoroughly before swallowing.||
0142|035|H|   If you are using the capsule form of the medication and||
0142|036|H|swallowing is difficult, the capsule may be opened and the powder||
0142|037|H|mixed with food or liquid.||
0142|038|H|   Be careful not to inhale any of the powder because doing so||
0142|039|H|can irritate the inside of the nose or cause an asthma attack.||
0142|040|H|   Use this medication regularly to get the most benefit from it.||
0142|041|H|   If your doctor has recommended that you follow a special diet,||
0142|042|H|it is very important to follow the diet to get the most benefit||
0142|043|H|from this medication.||
0142|044|H|   Do not change brands or dosage forms of this product without||
0142|045|H|consulting your doctor or pharmacist. Different products may||
0142|046|H|contain different amounts of the digestive enzymes.||
0142|047|H|   Tell your doctor if your condition lasts or gets worse.||
0142|048|B|||
0142|049|S|SIDE EFFECTS:  Diarrhea, abdominal pain/cramps, or nausea may||
0142|050|S|occur. If any of these effects last or get worse, tell your||
0142|051|S|doctor or pharmacist promptly.||
0142|052|S|   If your doctor has directed you to use this medication,||
0142|053|S|remember that your doctor has judged that the benefit to you is||
0142|054|S|greater than the risk of side effects. Many people using this||
0142|055|S|medication do not have serious side effects.||
0142|056|S|   Tell your doctor right away if you have any serious side||
0142|057|S|effects, including: severe abdominal discomfort, frequent/painful||
0142|058|S|urination, joint pain.||
0142|059|S|   A very serious allergic reaction to this drug is rare.||
0142|060|S|However, get medical help right away if you notice any symptoms||
0142|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0142|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0142|063|S|breathing.||
0142|064|S|   This is not a complete list of possible side effects. If you||
0142|065|S|notice other effects not listed above, contact your doctor or||
0142|066|S|pharmacist.||
0142|067|S|   In the US -||
0142|068|S|   Call your doctor for medical advice about side effects. You||
0142|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0142|070|S|www.fda.gov/medwatch.||
0142|071|S|   In Canada - Call your doctor for medical advice about side||
0142|072|S|effects. You may report side effects to Health Canada at||
0142|073|S|1-866-234-2345.||
0142|074|B|||
0142|075|P|PRECAUTIONS:  Before taking this digestive enzyme, tell your||
0142|076|P|doctor or pharmacist if you are allergic to it; or to pork||
0142|077|P|protein; or if you have any other allergies. This product may||
0142|078|P|contain inactive ingredients, which can cause allergic reactions||
0142|079|P|or other problems. Talk to your pharmacist for more details.||
0142|080|P|   Before using this medication, tell your doctor or pharmacist||
0142|081|P|your medical history, especially of: sudden/severe swelling of||
0142|082|P|the pancreas (acute pancreatitis), sudden worsening of long-term||
0142|083|P|disease of the pancreas.||
0142|084|P|   Before having surgery, tell your doctor or dentist about all||
0142|085|P|the products you use (including prescription drugs,||
0142|086|P|nonprescription drugs, and herbal products).||
0142|087|P|   During pregnancy, this medication should be used only when||
0142|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
0142|089|P|   It is unknown if this drug passes into breast milk. Consult||
0142|090|P|your doctor before breastfeeding.||
0142|091|B|||
0142|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0142|093|I|medications work or increase your risk for serious side effects.||
0142|094|I|This document does not contain all possible drug interactions.||
0142|095|I|Keep a list of all the products you use (including||
0142|096|I|prescription/nonprescription drugs and herbal products) and share||
0142|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
0142|098|I|the dosage of any medicines without your doctor's approval.||
0142|099|I|   Some products that may interact with this drug include:||
0142|100|I|acarbose, miglitol.||
0142|101|B|||
0142|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0142|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0142|104|O|poison control center right away. US residents can call||
0142|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0142|106|B|||
0142|107|N|NOTES:  Do not share this product with others.||
0142|108|B|||
0142|109|D|MISSED DOSE:  If you miss a dose, take the next dose with your||
0142|110|D|next meal or snack as directed. Do not double the dose to catch||
0142|111|D|up.||
0142|112|B|||
0142|113|R|STORAGE:  Store at room temperature away from light and moisture.||
0142|114|R|Do not store in the bathroom. Keep all medications away from||
0142|115|R|children and pets.||
0142|116|R|   Do not flush medications down the toilet or pour them into a||
0142|117|R|drain unless instructed to do so. Properly discard this product||
0142|118|R|when it is expired or no longer needed. Consult your pharmacist||
0142|119|R|or local waste disposal company.||
0142|120|B|||
0142|121|A|Information last revised May 2024.||
0142|122|A|Copyright(c) 2025 First Databank, Inc.||
0142|123|B|||
0143|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0143|002|Z|does NOT have all possible information about this product. This||
0143|003|Z|information does not assure that this product is safe, effective,||
0143|004|Z|or appropriate for you. This information is not individual||
0143|005|Z|medical advice and does not substitute for the advice of your||
0143|006|Z|health care professional. Always ask your health care||
0143|007|Z|professional for complete information about this product and your||
0143|008|Z|specific health needs.||
0143|009|B|||
0143|010|T|OMEPRAZOLE DELAYED-RELEASE CAPSULE - ORAL||
0143|011|F|(oh-MEP-ra-zole)||
0143|012|B|||
0143|013|C|COMMON BRAND NAME(S): Prilosec||
0143|014|B|||
0143|015|U|USES:  Omeprazole is used to treat certain stomach and esophagus||
0143|016|U|problems (such as acid reflux, ulcers). It works by decreasing||
0143|017|U|the amount of acid your stomach makes. It relieves symptoms such||
0143|018|U|as heartburn, difficulty swallowing, and cough. This medication||
0143|019|U|helps heal acid damage to the stomach and esophagus, helps||
0143|020|U|prevent ulcers, and may help prevent cancer of the esophagus.||
0143|021|U|Omeprazole belongs to a class of drugs known as proton pump||
0143|022|U|inhibitors (PPIs).||
0143|023|U|   If you are self-treating with this medication,||
0143|024|U|over-the-counter omeprazole products are used to treat frequent||
0143|025|U|heartburn (occurring 2 or more days a week). Since it may take 1||
0143|026|U|to 4 days to have full effect, these products do not relieve||
0143|027|U|heartburn right away.||
0143|028|U|   For over-the-counter products, carefully read the package||
0143|029|U|instructions to make sure the product is right for you. Check the||
0143|030|U|ingredients on the label even if you have used the product||
0143|031|U|before. The manufacturer may have changed the ingredients. Also,||
0143|032|U|products with similar brand names may contain different||
0143|033|U|ingredients meant for different purposes. Taking the wrong||
0143|034|U|product could harm you.||
0143|035|B|||
0143|036|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0143|037|H|Patient Information Leaflet provided by your pharmacist before||
0143|038|H|you start taking omeprazole and each time you get a refill. If||
0143|039|H|you have any questions, ask your doctor or pharmacist.||
0143|040|H|   Take this medication by mouth before a meal as directed by||
0143|041|H|your doctor, usually once daily. If you are self-treating, follow||
0143|042|H|all directions on the product package. The dosage and length of||
0143|043|H|treatment are based on your medical condition and response to||
0143|044|H|treatment. Children's dosage is also based on weight. Do not||
0143|045|H|increase your dose or take this drug more often than directed. If||
0143|046|H|you have any questions, ask your doctor or pharmacist.||
0143|047|H|   Do not crush, break, or chew this medication. Swallow the||
0143|048|H|capsules whole. If you have trouble swallowing the capsule, you||
0143|049|H|may open the capsule if it is not sealed and carefully sprinkle||
0143|050|H|its contents on a spoonful of soft, cool applesauce. Swallow all||
0143|051|H|of the mixture right away without chewing it. Then drink a glass||
0143|052|H|of cool water to make sure you have swallowed all of the dose. Do||
0143|053|H|not prepare the mixture ahead of time for later use. Doing so may||
0143|054|H|destroy the drug.||
0143|055|H|   If needed, antacids may be taken along with this medication.||
0143|056|H|If you are also taking sucralfate, take omeprazole at least 30||
0143|057|H|minutes before sucralfate.||
0143|058|H|   Use this medication regularly to get the most benefit from it.||
0143|059|H|To help you remember, take it at the same time each day. Continue||
0143|060|H|to take this medication for the prescribed length of treatment||
0143|061|H|even if you are feeling better. If you are self-treating with the||
0143|062|H|over-the-counter product, do not take it for more than 14 days||
0143|063|H|unless directed by your doctor.||
0143|064|H|   Tell your doctor if your condition lasts or gets worse. If you||
0143|065|H|are self-treating, tell your doctor if your heartburn lasts after||
0143|066|H|14 days or if you need to use this medication more than once||
0143|067|H|every 4 months. The risk of side effects goes up over time. Ask||
0143|068|H|your doctor how long you should take this medication. If you||
0143|069|H|think you may have a serious medical problem, get medical help||
0143|070|H|right away.||
0143|071|B|||
0143|072|S|SIDE EFFECTS:  See also Precautions section.||
0143|073|S|   Headache or abdominal pain may occur. If any of these effects||
0143|074|S|last or get worse, tell your doctor or pharmacist promptly.||
0143|075|S|   If your doctor has directed you to use this product, remember||
0143|076|S|that your doctor has judged that the benefit to you is greater||
0143|077|S|than the risk of side effects. Many people using this medication||
0143|078|S|do not have serious side effects.||
0143|079|S|   Tell your doctor right away if you have any serious side||
0143|080|S|effects, including: symptoms of a low magnesium blood level (such||
0143|081|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
0143|082|S|(such as rash on nose and cheeks, new or worsening joint pain),||
0143|083|S|signs of kidney problems (such as change in the amount of urine,||
0143|084|S|pink/bloody urine).||
0143|085|S|   This medication may rarely cause a severe intestinal condition||
0143|086|S|due to a bacteria called C. difficile. This condition may occur||
0143|087|S|during treatment or weeks to months after treatment has stopped.||
0143|088|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0143|089|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0143|090|S|stool.||
0143|091|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0143|092|S|products because they may make symptoms worse.||
0143|093|S|   Rarely, proton pump inhibitors (such as omeprazole) have||
0143|094|S|caused vitamin B-12 deficiency. The risk is increased if they are||
0143|095|S|taken every day for a long time (3 years or longer). Tell your||
0143|096|S|doctor right away if you develop symptoms of vitamin B-12||
0143|097|S|deficiency (such as unusual weakness, sore tongue, or||
0143|098|S|numbness/tingling of the hands/feet).||
0143|099|S|   A very serious allergic reaction to this drug is rare.||
0143|100|S|However, get medical help right away if you notice any symptoms||
0143|101|S|of a serious allergic reaction, including: fever, swollen lymph||
0143|102|S|nodes, rash, itching/swelling (especially of the||
0143|103|S|face/tongue/throat), severe dizziness, trouble breathing.||
0143|104|S|   This is not a complete list of possible side effects. If you||
0143|105|S|notice other effects not listed above, contact your doctor or||
0143|106|S|pharmacist.||
0143|107|S|   In the US -||
0143|108|S|   Call your doctor for medical advice about side effects. You||
0143|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0143|110|S|www.fda.gov/medwatch.||
0143|111|S|   In Canada - Call your doctor for medical advice about side||
0143|112|S|effects. You may report side effects to Health Canada at||
0143|113|S|1-866-234-2345.||
0143|114|B|||
0143|115|P|PRECAUTIONS:  Before taking omeprazole, tell your doctor or||
0143|116|P|pharmacist if you are allergic to it; or to similar drugs (such||
0143|117|P|as esomeprazole, lansoprazole, pantoprazole); or if you have any||
0143|118|P|other allergies. This product may contain inactive ingredients,||
0143|119|P|which can cause allergic reactions or other problems. Talk to||
0143|120|P|your pharmacist for more details.||
0143|121|P|   Before using this medication, tell your doctor or pharmacist||
0143|122|P|your medical history, especially of: liver disease, lupus.||
0143|123|P|   Some symptoms may actually be signs of a more serious||
0143|124|P|condition. Get medical help right away if you have: heartburn||
0143|125|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
0143|126|P|pain (especially with shortness of breath, unusual sweating),||
0143|127|P|unexplained weight loss.||
0143|128|P|   In addition, before you self-treat with this medication, get||
0143|129|P|medical help right away if you have any of these signs of a||
0143|130|P|serious condition: trouble/pain swallowing food, bloody vomit,||
0143|131|P|vomit that looks like coffee grounds, bloody/black stools,||
0143|132|P|heartburn for over 3 months, frequent chest pain, frequent||
0143|133|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
0143|134|P|pain.||
0143|135|P|   Before having surgery, tell your doctor or dentist about all||
0143|136|P|the products you use (including prescription drugs,||
0143|137|P|nonprescription drugs, and herbal products).||
0143|138|P|   Proton pump inhibitors (such as omeprazole) may increase your||
0143|139|P|risk for bone fractures, especially with longer use, higher||
0143|140|P|doses, and in older adults. Talk with your doctor or pharmacist||
0143|141|P|about ways to prevent bone loss/fracture, such as by taking||
0143|142|P|calcium (such as calcium citrate) and vitamin D supplements.||
0143|143|P|   Older adults may be more sensitive to the side effects of this||
0143|144|P|drug, especially bone loss and fractures (see above), and C.||
0143|145|P|difficile infection (see Side Effects section).||
0143|146|P|   Children may be more sensitive to the side effects of this||
0143|147|P|drug, especially fever, cough, and infections of the||
0143|148|P|nose/throat/airways.||
0143|149|P|   During pregnancy, this medication should be used only when||
0143|150|P|clearly needed. Discuss the risks and benefits with your doctor.||
0143|151|P|   This medication passes into breast milk. The effects on a||
0143|152|P|nursing infant are unknown. Consult your doctor before||
0143|153|P|breastfeeding.||
0143|154|B|||
0143|155|I|DRUG INTERACTIONS:  See also How to Use section.||
0143|156|I|   Drug interactions may change how your medications work or||
0143|157|I|increase your risk for serious side effects. This document does||
0143|158|I|not contain all possible drug interactions. Keep a list of all||
0143|159|I|the products you use (including prescription/nonprescription||
0143|160|I|drugs and herbal products) and share it with your doctor and||
0143|161|I|pharmacist. Do not start, stop, or change the dosage of any||
0143|162|I|medicines without your doctor's approval.||
0143|163|I|   Some products that may interact with this drug include:||
0143|164|I|clopidogrel, methotrexate (especially high-dose treatment),||
0143|165|I|rifampin, St John's wort.||
0143|166|I|   Some products need stomach acid so that the body can absorb||
0143|167|I|them properly. Omeprazole decreases stomach acid, so it may||
0143|168|I|change how well these products work. Some affected products||
0143|169|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
0143|170|I|pazopanib, rilpivirine, sparsentan, certain azole antifungals||
0143|171|I|(itraconazole, ketoconazole, posaconazole), among others.||
0143|172|I|   Omeprazole is very similar to esomeprazole. Do not use any||
0143|173|I|medications containing esomeprazole while using omeprazole.||
0143|174|I|   This medication may interfere with certain lab tests, possibly||
0143|175|I|causing false test results. Make sure lab personnel and all your||
0143|176|I|doctors know you use this drug.||
0143|177|B|||
0143|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0143|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0143|180|O|poison control center right away. US residents can call||
0143|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0143|182|O|Symptoms of overdose may include: confusion, unusual sweating,||
0143|183|O|blurred vision, unusually fast heartbeat.||
0143|184|B|||
0143|185|N|NOTES:  If your doctor has prescribed this medication for you, do||
0143|186|N|not share it with others.||
0143|187|N|   If your doctor instructs you to use this medication regularly||
0143|188|N|for a long time, lab and/or medical tests (such as a magnesium||
0143|189|N|blood test, vitamin B-12 levels) may be done while you are taking||
0143|190|N|this medication. Keep all medical and lab appointments. Consult||
0143|191|N|your doctor for more details.||
0143|192|B|||
0143|193|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0143|194|D|remember. If it is near the time of the next dose, skip the||
0143|195|D|missed dose. Take your next dose at the regular time. Do not||
0143|196|D|double the dose to catch up.||
0143|197|B|||
0143|198|R|STORAGE:  Store at room temperature away from light and moisture.||
0143|199|R|Do not store in the bathroom. Keep all medications away from||
0143|200|R|children and pets.||
0143|201|R|   Do not flush medications down the toilet or pour them into a||
0143|202|R|drain unless instructed to do so. Properly discard this product||
0143|203|R|when it is expired or no longer needed. Consult your pharmacist||
0143|204|R|or local waste disposal company.||
0143|205|B|||
0143|206|A|Information last revised April 2025.||
0143|207|A|Copyright(c) 2025 First Databank, Inc.||
0143|208|B|||
0144|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0144|002|Z|does NOT have all possible information about this product. This||
0144|003|Z|information does not assure that this product is safe, effective,||
0144|004|Z|or appropriate for you. This information is not individual||
0144|005|Z|medical advice and does not substitute for the advice of your||
0144|006|Z|health care professional. Always ask your health care||
0144|007|Z|professional for complete information about this product and your||
0144|008|Z|specific health needs.||
0144|009|B|||
0144|010|T|INDAPAMIDE - ORAL||
0144|011|F|(in-DAP-a-mide)||
0144|012|B|||
0144|013|C|COMMON BRAND NAME(S): Lozol||
0144|014|B|||
0144|015|U|USES:  This medication is used to treat high blood pressure.||
0144|016|U|Indapamide is also used to reduce extra fluid in the body (edema)||
0144|017|U|caused by heart failure. Lowering high blood pressure helps||
0144|018|U|prevent strokes, heart attacks, and kidney problems. Indapamide||
0144|019|U|belongs to a class of drugs known as diuretics/"water pills." It||
0144|020|U|works by causing you to make more urine. This helps your body get||
0144|021|U|rid of extra salt and water. This can lessen symptoms such as||
0144|022|U|shortness of breath or swelling in your ankles or feet.||
0144|023|B|||
0144|024|H|HOW TO USE:  Take this medication by mouth with or without food||
0144|025|H|as directed by your doctor, usually once daily in the morning. If||
0144|026|H|you take this drug too close to bedtime, you may need to wake up||
0144|027|H|to urinate. It is best to take this medication at least 4 hours||
0144|028|H|before your bedtime.||
0144|029|H|   The dosage is based on your medical condition and response to||
0144|030|H|treatment.||
0144|031|H|   Take this medication regularly in order to get the most||
0144|032|H|benefit from it. To help you remember, take it at the same time||
0144|033|H|each day. Keep taking this medication even if you feel well. Most||
0144|034|H|people with high blood pressure do not feel sick. It may take up||
0144|035|H|to several weeks before you get the full benefit of this drug.||
0144|036|H|   If you also take certain drugs to lower your cholesterol (bile||
0144|037|H|acid-binding resins such as cholestyramine or colestipol), take||
0144|038|H|indapamide at least 4 hours before or at least 4 hours after||
0144|039|H|these medications.||
0144|040|H|   Tell your doctor if your condition does not get better or if||
0144|041|H|it gets worse (for example, your blood pressure readings remain||
0144|042|H|high or increase).||
0144|043|B|||
0144|044|S|SIDE EFFECTS:  Dizziness or headache may occur. If any of these||
0144|045|S|effects last or get worse, tell your doctor or pharmacist||
0144|046|S|promptly.||
0144|047|S|   Remember that this medication has been prescribed because your||
0144|048|S|doctor has judged that the benefit to you is greater than the||
0144|049|S|risk of side effects. Many people using this medication do not||
0144|050|S|have serious side effects.||
0144|051|S|   This medication may cause dehydration and electrolyte||
0144|052|S|imbalance. Tell your doctor right away if you have any symptoms||
0144|053|S|of dehydration or electrolyte imbalance, including unusual dry||
0144|054|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0144|055|S|heartbeat, unusual decreased urination, or confusion.||
0144|056|S|   Tell your doctor right away if you have any serious side||
0144|057|S|effects, including: fainting, decrease in vision, eye pain.||
0144|058|S|   A very serious allergic reaction to this drug is rare.||
0144|059|S|However, get medical help right away if you notice any symptoms||
0144|060|S|of a serious allergic reaction, including: rash, itching/swelling||
0144|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0144|062|S|breathing.||
0144|063|S|   This is not a complete list of possible side effects. If you||
0144|064|S|notice other effects not listed above, contact your doctor or||
0144|065|S|pharmacist.||
0144|066|S|   In the US -||
0144|067|S|   Call your doctor for medical advice about side effects. You||
0144|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0144|069|S|www.fda.gov/medwatch.||
0144|070|S|   In Canada - Call your doctor for medical advice about side||
0144|071|S|effects. You may report side effects to Health Canada at||
0144|072|S|1-866-234-2345.||
0144|073|B|||
0144|074|P|PRECAUTIONS:  Before taking indapamide, tell your doctor or||
0144|075|P|pharmacist if you are allergic to it; or if you have any other||
0144|076|P|allergies. This product may contain inactive ingredients, which||
0144|077|P|can cause allergic reactions or other problems. Talk to your||
0144|078|P|pharmacist for more details.||
0144|079|P|   Before using this medication, tell your doctor or pharmacist||
0144|080|P|your medical history, especially of: diabetes, gout, kidney||
0144|081|P|problems, liver disease, lupus.||
0144|082|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0144|083|P|can make you more dizzy. Do not drive, use machinery, or do||
0144|084|P|anything that needs alertness until you can do it safely. Limit||
0144|085|P|alcoholic beverages. Talk to your doctor if you are using||
0144|086|P|marijuana (cannabis).||
0144|087|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0144|088|P|and cause you to feel lightheaded. Tell your doctor if you have||
0144|089|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0144|090|P|of fluids unless your doctor tells you not to.||
0144|091|P|   If you have diabetes, this product may increase your blood||
0144|092|P|sugar. Check your blood sugar regularly as directed and share the||
0144|093|P|results with your doctor. Tell your doctor right away if you have||
0144|094|P|symptoms of high blood sugar such as increased thirst/urination.||
0144|095|P|Your doctor may need to adjust your diabetes medication, exercise||
0144|096|P|program, or diet.||
0144|097|P|   This medication may decrease your level of potassium in the||
0144|098|P|blood. Before using potassium supplements or salt substitutes||
0144|099|P|containing potassium, consult your doctor or pharmacist.||
0144|100|P|   This medication may make you more sensitive to the sun. Limit||
0144|101|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0144|102|P|sunscreen and wear protective clothing when outdoors. Tell your||
0144|103|P|doctor right away if you get sunburned or have skin||
0144|104|P|blisters/redness.||
0144|105|P|   Before having surgery, tell your doctor or dentist about all||
0144|106|P|the products you use (including prescription drugs,||
0144|107|P|nonprescription drugs, and herbal products).||
0144|108|P|   During pregnancy, this medication should be used only when||
0144|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
0144|110|P|   It is unknown if this medication passes into breast milk.||
0144|111|P|Consult your doctor before breastfeeding.||
0144|112|B|||
0144|113|I|DRUG INTERACTIONS:  See also How to Use section.||
0144|114|I|   Drug interactions may change how your medications work or||
0144|115|I|increase your risk for serious side effects. This document does||
0144|116|I|not contain all possible drug interactions. Keep a list of all||
0144|117|I|the products you use (including prescription/nonprescription||
0144|118|I|drugs and herbal products) and share it with your doctor and||
0144|119|I|pharmacist. Do not start, stop, or change the dosage of any||
0144|120|I|medicines without your doctor's approval.||
0144|121|I|   Some products that may interact with this drug include:||
0144|122|I|dofetilide, lithium.||
0144|123|I|   Some products have ingredients that could raise your blood||
0144|124|I|pressure or worsen your heart failure. Tell your pharmacist what||
0144|125|I|products you are using, and ask how to use them safely||
0144|126|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0144|127|I|ibuprofen/naproxen).||
0144|128|I|   This medication may interfere with certain lab tests||
0144|129|I|(including parathyroid function), possibly causing false test||
0144|130|I|results. Make sure lab personnel and all your doctors know you||
0144|131|I|use this drug.||
0144|132|B|||
0144|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0144|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0144|135|O|poison control center right away. US residents can call||
0144|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0144|137|B|||
0144|138|N|NOTES:  Do not share this medication with others.||
0144|139|N|   Lab and/or medical tests (such as potassium levels, kidney||
0144|140|N|function) should be done while you are taking this medication.||
0144|141|N|Keep all medical and lab appointments. Consult your doctor for||
0144|142|N|more details.||
0144|143|N|   Lifestyle changes that may help this medication work better||
0144|144|N|include exercising, stopping smoking, and eating a||
0144|145|N|low-cholesterol/low-fat diet. Consult your doctor for more||
0144|146|N|details.||
0144|147|N|   Check your blood pressure and pulse (heart rate) regularly||
0144|148|N|while taking this medication. Learn how to check your own blood||
0144|149|N|pressure and pulse at home, and share the results with your||
0144|150|N|doctor.||
0144|151|B|||
0144|152|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0144|153|D|remember. If it is near the time of the next dose, skip the||
0144|154|D|missed dose. Take your next dose at the regular time. Do not||
0144|155|D|double the dose to catch up.||
0144|156|B|||
0144|157|R|STORAGE:  Store at room temperature away from light and moisture.||
0144|158|R|Do not store in the bathroom. Keep all medications away from||
0144|159|R|children and pets.||
0144|160|R|   Do not flush medications down the toilet or pour them into a||
0144|161|R|drain unless instructed to do so. Properly discard this product||
0144|162|R|when it is expired or no longer needed. Consult your pharmacist||
0144|163|R|or local waste disposal company.||
0144|164|B|||
0144|165|A|Information last revised May 2024.||
0144|166|A|Copyright(c) 2025 First Databank, Inc.||
0144|167|B|||
0145|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0145|002|Z|does NOT have all possible information about this product. This||
0145|003|Z|information does not assure that this product is safe, effective,||
0145|004|Z|or appropriate for you. This information is not individual||
0145|005|Z|medical advice and does not substitute for the advice of your||
0145|006|Z|health care professional. Always ask your health care||
0145|007|Z|professional for complete information about this product and your||
0145|008|Z|specific health needs.||
0145|009|B|||
0145|010|T|MEXILETINE - ORAL||
0145|011|F|(mex-IL-e-teen)||
0145|012|B|||
0145|013|C|COMMON BRAND NAME(S): Mexitil||
0145|014|B|||
0145|015|W|WARNING:  Though this medication often gives great benefits to||
0145|016|W|people with irregular heartbeat, it may rarely cause a serious||
0145|017|W|new irregular heartbeat. When starting treatment with this drug,||
0145|018|W|your doctor may recommend that you stay in the hospital for||
0145|019|W|proper monitoring. Talk with your doctor about the benefits and||
0145|020|W|risks of taking this medication for your condition.||
0145|021|B|||
0145|022|U|USES:  This medication is used to treat certain types of serious||
0145|023|U|(possibly fatal) irregular heartbeat (such as sustained||
0145|024|U|ventricular tachycardia). It is used to restore normal heart||
0145|025|U|rhythm and maintain a regular, steady heartbeat. Mexiletine is||
0145|026|U|known as an anti-arrhythmic drug. It works by blocking certain||
0145|027|U|electrical signals in the heart that can cause an irregular||
0145|028|U|heartbeat. Treating an irregular heartbeat can decrease the risk||
0145|029|U|for blood clots, and this effect can reduce your risk of heart||
0145|030|U|attack or stroke.||
0145|031|B|||
0145|032|V|OTHER USES:  This section contains uses of this drug that are not||
0145|033|V|listed in the approved professional labeling for the drug but||
0145|034|V|that may be prescribed by your health care professional. Use this||
0145|035|V|drug for a condition that is listed in this section only if it||
0145|036|V|has been so prescribed by your health care professional.||
0145|037|V|   This drug may also be used for pain, numbness, and tingling||
0145|038|V|from a certain nerve problem (peripheral neuropathy) which may||
0145|039|V|occur in people with diabetes.||
0145|040|B|||
0145|041|H|HOW TO USE:  Take this medication by mouth with food or an||
0145|042|H|antacid as directed by your doctor, usually 2 to 3 times daily.||
0145|043|H|Taking this medication with food or an antacid helps to decrease||
0145|044|H|certain side effects (nausea, heartburn). Ask your pharmacist if||
0145|045|H|you have questions about which antacids to use with this||
0145|046|H|medication. Take this medication with a full glass of water (8||
0145|047|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
0145|048|H|   The dosage is based on your age, medical condition, and||
0145|049|H|response to treatment.||
0145|050|H|   Use this medication regularly to get the most benefit from it.||
0145|051|H|To help you remember, take it at the same times each day.||
0145|052|H|   Tell your doctor if your condition does not get better or if||
0145|053|H|it gets worse.||
0145|054|B|||
0145|055|S|SIDE EFFECTS:  See also Warning section.||
0145|056|S|   Nausea, vomiting, heartburn, dizziness, lightheadedness,||
0145|057|S|vision problems (such as blurred vision), headache, shaking,||
0145|058|S|nervousness, or problems with muscle control (coordination||
0145|059|S|difficulties) may occur. If any of these effects last or get||
0145|060|S|worse, tell your doctor or pharmacist promptly.||
0145|061|S|   Remember that this medication has been prescribed because your||
0145|062|S|doctor has judged that the benefit to you is greater than the||
0145|063|S|risk of side effects. Many people using this medication do not||
0145|064|S|have serious side effects.||
0145|065|S|   Tell your doctor right away if you have any serious side||
0145|066|S|effects, including: worsening symptoms of heart failure (such as||
0145|067|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
0145|068|S|unusual/sudden weight gain), signs of liver problems (such as||
0145|069|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
0145|070|S|yellowing eyes/skin, dark urine).||
0145|071|S|   Get medical help right away if you have any very serious side||
0145|072|S|effects, including: chest pain, seizure.||
0145|073|S|   A very serious allergic reaction to this drug is rare.||
0145|074|S|However, get medical help right away if you notice any symptoms||
0145|075|S|of a serious allergic reaction, including: fever, swollen lymph||
0145|076|S|nodes, rash, itching/swelling (especially of the||
0145|077|S|face/tongue/throat), severe dizziness, trouble breathing.||
0145|078|S|   This is not a complete list of possible side effects. If you||
0145|079|S|notice other effects not listed above, contact your doctor or||
0145|080|S|pharmacist.||
0145|081|S|   In the US -||
0145|082|S|   Call your doctor for medical advice about side effects. You||
0145|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0145|084|S|www.fda.gov/medwatch.||
0145|085|S|   In Canada - Call your doctor for medical advice about side||
0145|086|S|effects. You may report side effects to Health Canada at||
0145|087|S|1-866-234-2345.||
0145|088|B|||
0145|089|P|PRECAUTIONS:  Before taking mexiletine, tell your doctor or||
0145|090|P|pharmacist if you are allergic to it; or if you have any other||
0145|091|P|allergies. This product may contain inactive ingredients, which||
0145|092|P|can cause allergic reactions or other problems. Talk to your||
0145|093|P|pharmacist for more details.||
0145|094|P|   Before using this medication, tell your doctor or pharmacist||
0145|095|P|your medical history, especially of: other heart problems (such||
0145|096|P|as heart failure, slow heartbeat, previous heart attack), liver||
0145|097|P|problems, seizure disorder.||
0145|098|P|   This drug may make you dizzy or blur your vision. Alcohol or||
0145|099|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
0145|100|P|machinery, or do anything that needs alertness or clear vision||
0145|101|P|until you can do it safely. Limit alcoholic beverages. Talk to||
0145|102|P|your doctor if you are using marijuana (cannabis).||
0145|103|P|   Before having surgery, tell your doctor or dentist about all||
0145|104|P|the products you use (including prescription drugs,||
0145|105|P|nonprescription drugs, and herbal products).||
0145|106|P|   During pregnancy, this medication should be used only when||
0145|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
0145|108|P|   This medication passes into breast milk. However, this drug is||
0145|109|P|unlikely to harm a nursing infant. Consult your doctor before||
0145|110|P|breastfeeding.||
0145|111|B|||
0145|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0145|113|I|medications work or increase your risk for serious side effects.||
0145|114|I|This document does not contain all possible drug interactions.||
0145|115|I|Keep a list of all the products you use (including||
0145|116|I|prescription/nonprescription drugs and herbal products) and share||
0145|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
0145|118|I|the dosage of any medicines without your doctor's approval.||
0145|119|I|   Some products that may interact with this drug are: caffeine,||
0145|120|I|fezolinetant, theophylline, drugs that may affect the acid level||
0145|121|I|of urine (such as sodium bicarbonate, large doses of vitamin C).||
0145|122|I|   Other medications can affect the removal of mexiletine from||
0145|123|I|your body, which may affect how mexiletine works. Examples||
0145|124|I|include cimetidine, fluvoxamine, propafenone, anti-seizure drugs||
0145|125|I|(such as phenytoin, phenobarbital), among others.||
0145|126|B|||
0145|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0145|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0145|129|O|poison control center right away. US residents can call||
0145|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0145|131|O|Symptoms of overdose may include: drowsiness, confusion,||
0145|132|O|fainting, seizures.||
0145|133|B|||
0145|134|N|NOTES:  Do not share this medication with others.||
0145|135|N|   Lab and/or medical tests (such as EKG, blood pressure, liver||
0145|136|N|function) should be done while you are taking this medication.||
0145|137|N|Keep all medical and lab appointments. Consult your doctor for||
0145|138|N|more details.||
0145|139|B|||
0145|140|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0145|141|D|remember. If it is near the time of the next dose, skip the||
0145|142|D|missed dose. Take your next dose at the regular time. Do not||
0145|143|D|double the dose to catch up.||
0145|144|B|||
0145|145|R|STORAGE:  Store at room temperature away from light and moisture.||
0145|146|R|Do not store in the bathroom. Keep all medications away from||
0145|147|R|children and pets.||
0145|148|R|   Do not flush medications down the toilet or pour them into a||
0145|149|R|drain unless instructed to do so. Properly discard this product||
0145|150|R|when it is expired or no longer needed. Consult your pharmacist||
0145|151|R|or local waste disposal company.||
0145|152|B|||
0145|153|M|MEDICAL ALERT:  Your condition can cause complications in a||
0145|154|M|medical emergency. For information about enrolling in MedicAlert,||
0145|155|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0145|156|B|||
0145|157|A|Information last revised October 2024.||
0145|158|A|Copyright(c) 2025 First Databank, Inc.||
0145|159|B|||
0146|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0146|002|Z|does NOT have all possible information about this product. This||
0146|003|Z|information does not assure that this product is safe, effective,||
0146|004|Z|or appropriate for you. This information is not individual||
0146|005|Z|medical advice and does not substitute for the advice of your||
0146|006|Z|health care professional. Always ask your health care||
0146|007|Z|professional for complete information about this product and your||
0146|008|Z|specific health needs.||
0146|009|B|||
0146|010|T|TRIAMCINOLONE - INJECTION||
0146|011|F|(TRYE-am-SIN-oh-lone)||
0146|012|B|||
0146|013|C|COMMON BRAND NAME(S): Aristospan, Kenalog||
0146|014|B|||
0146|015|U|USES:  This medication is used in a variety of conditions such as||
0146|016|U|allergic disorders, arthritis, gout, blood diseases, breathing||
0146|017|U|problems, certain cancers, eye diseases, intestinal disorders,||
0146|018|U|collagen and skin diseases. Talk to your doctor about the risks||
0146|019|U|and benefits of triamcinolone, especially if it is to be injected||
0146|020|U|near your spine (epidural). Rare but serious side effects may||
0146|021|U|occur with epidural use.||
0146|022|U|   Triamcinolone is known as a corticosteroid hormone||
0146|023|U|(glucocorticoid). It works by decreasing your body's immune||
0146|024|U|response to these diseases and reduces symptoms such as swelling.||
0146|025|B|||
0146|026|H|HOW TO USE:  Depending on your product, this medication may be||
0146|027|H|given by injecting into different locations such as a muscle, a||
0146|028|H|skin lesion, or a joint. Injections are usually given by a||
0146|029|H|trained healthcare professional. If you are giving the injection||
0146|030|H|yourself into a muscle, you will be taught by your healthcare||
0146|031|H|professional on how to properly use this medication. If any of||
0146|032|H|the information is unclear, consult your healthcare professional.||
0146|033|H|   The injection site, schedule, dosage, and length of treatment||
0146|034|H|are based on your medical condition and response to treatment. Do||
0146|035|H|not inject this medication into a vein or into the area around||
0146|036|H|the spinal cord (epidural). This medication is not recommended||
0146|037|H|for injection around/into the eye or certain parts of the nose||
0146|038|H|due to the risk for blindness or damage to the eye(s). Consult||
0146|039|H|your doctor for more details.||
0146|040|H|   Use this medication and follow the dosing schedule exactly as||
0146|041|H|directed by your doctor in order to get the most benefit from it.||
0146|042|H|Do not change your dose or use this medication for a longer time||
0146|043|H|than prescribed. Be sure to ask your doctor or pharmacist if you||
0146|044|H|have any questions about your treatment.||
0146|045|H|   Wash hands with soap and water before using this medication.||
0146|046|H|Before using, check this product for particles or discoloration.||
0146|047|H|If either is present, do not use the liquid.||
0146|048|H|   Before injecting each dose into a muscle, clean the injection||
0146|049|H|site with rubbing alcohol. It is important to change the location||
0146|050|H|of the injection site to avoid discomfort or problem areas. Your||
0146|051|H|dose may need to be gradually decreased to reduce symptoms such||
0146|052|H|as weakness, weight loss, nausea, and extreme tiredness.||
0146|053|H|   Shake vial before use to evenly disperse the suspension.||
0146|054|H|Inject the prescribed dose immediately after withdrawing it into||
0146|055|H|the syringe to avoid settling of the medication in the syringe.||
0146|056|H|   Learn how to store and discard syringes, needles, and medical||
0146|057|H|supplies safely. Consult your pharmacist for more information.||
0146|058|H|   If you have been using this medication for a long time, do not||
0146|059|H|suddenly stop it without your doctor's approval. Some conditions||
0146|060|H|may become worse when this drug is suddenly stopped.||
0146|061|H|   This medication may be injected into a joint to treat||
0146|062|H|conditions such as arthritis and bursitis. If you have received||
0146|063|H|an injection into a joint, be careful how much stress you put on||
0146|064|H|that joint, even if it is feeling better. Ask your doctor how||
0146|065|H|much you can move the joint while it is healing.||
0146|066|H|   Tell your doctor if your condition gets worse or if you have||
0146|067|H|new symptoms.||
0146|068|B|||
0146|069|S|SIDE EFFECTS:  Redness or pain at the injection site, stomach||
0146|070|S|upset, headache, dizziness, trouble sleeping, or weight gain may||
0146|071|S|occur. If any of these effects last or get worse, tell your||
0146|072|S|doctor or pharmacist promptly.||
0146|073|S|   Remember that this medication has been prescribed because your||
0146|074|S|doctor has judged that the benefit to you is greater than the||
0146|075|S|risk of side effects. Many people using this medication do not||
0146|076|S|have serious side effects.||
0146|077|S|   This medication may raise your blood pressure. Check your||
0146|078|S|blood pressure regularly and tell your doctor if the results are||
0146|079|S|high.||
0146|080|S|   This medication may make your blood sugar rise, which can||
0146|081|S|cause or worsen diabetes. Tell your doctor right away if you have||
0146|082|S|symptoms of high blood sugar such as increased thirst/urination.||
0146|083|S|If you already have diabetes, check your blood sugar regularly as||
0146|084|S|directed and share the results with your doctor. Your doctor may||
0146|085|S|need to adjust your diabetes medication, exercise program, or||
0146|086|S|diet.||
0146|087|S|   This medication may lower your ability to fight infections.||
0146|088|S|This may make you more likely to get a serious (rarely fatal)||
0146|089|S|infection or make any infection you have worse. Tell your doctor||
0146|090|S|right away if you have any signs of infection (such as sore||
0146|091|S|throat that doesn't go away, fever, chills).||
0146|092|S|   Tell your doctor right away if you have any serious side||
0146|093|S|effects, including: weakness, puffy face, unusual weight gain,||
0146|094|S|thinning skin, bone pain, menstrual period changes, mental/mood||
0146|095|S|changes (such as depression, mood swings, agitation), easy||
0146|096|S|bruising/bleeding, vision problems, swelling ankles/feet/hands,||
0146|097|S|fast/slow/irregular heartbeat, red/purple spots on the skin.||
0146|098|S|   If you have received injection of this medication into the||
0146|099|S|joint, temporary discomfort of the joint may occur. Tell your||
0146|100|S|doctor right away if you have fever, increased/severe pain with||
0146|101|S|swelling of the joint, weakness in the joint, or decreased range||
0146|102|S|of motion in the joint.||
0146|103|S|   Get medical help right away if you have any very serious side||
0146|104|S|effects, including: symptoms of stomach/intestinal bleeding (such||
0146|105|S|as stomach/abdominal pain, black/tarry stools, vomit that looks||
0146|106|S|like coffee grounds).||
0146|107|S|   A very serious allergic reaction to this drug is rare.||
0146|108|S|However, get medical help right away if you notice any symptoms||
0146|109|S|of a serious allergic reaction, including: rash, itching/swelling||
0146|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0146|111|S|breathing.||
0146|112|S|   This is not a complete list of possible side effects. If you||
0146|113|S|notice other effects not listed above, contact your doctor or||
0146|114|S|pharmacist.||
0146|115|S|   In the US -||
0146|116|S|   Call your doctor for medical advice about side effects. You||
0146|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0146|118|S|www.fda.gov/medwatch.||
0146|119|S|   In Canada - Call your doctor for medical advice about side||
0146|120|S|effects. You may report side effects to Health Canada at||
0146|121|S|1-866-234-2345.||
0146|122|B|||
0146|123|P|PRECAUTIONS:  Before using triamcinolone, tell your doctor or||
0146|124|P|pharmacist if you are allergic to it; or to other corticosteroids||
0146|125|P|(such as methylprednisolone); or if you have any other allergies.||
0146|126|P|This product may contain inactive ingredients, which can cause||
0146|127|P|allergic reactions or other problems. Talk to your pharmacist for||
0146|128|P|more details.||
0146|129|P|   Before using this medication, tell your doctor or pharmacist||
0146|130|P|your medical history, especially of: bleeding problems, blood||
0146|131|P|clots, bone loss (osteoporosis), diabetes, certain eye diseases||
0146|132|P|(such as cataracts, glaucoma, herpes infection of the eye), heart||
0146|133|P|problems (such as heart failure, recent heart attack), high blood||
0146|134|P|pressure, current/past infections (such as joint infections and||
0146|135|P|infections caused by fungus, herpes, tuberculosis, threadworm),||
0146|136|P|kidney disease, liver disease (such as hepatitis B), mental/mood||
0146|137|P|conditions (such as psychosis, anxiety, depression),||
0146|138|P|stomach/intestinal problems (such as diverticulitis, ulcer,||
0146|139|P|ulcerative colitis), seizures, thyroid problems, mineral||
0146|140|P|imbalance, a certain adrenal gland tumor (pheochromocytoma).||
0146|141|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0146|142|P|can make you more dizzy. Do not drive, use machinery, or do||
0146|143|P|anything that needs alertness until you can do it safely. Limit||
0146|144|P|alcoholic beverages. Talk to your doctor if you are using||
0146|145|P|marijuana (cannabis).||
0146|146|P|   Using corticosteroid medications for a long time can make it||
0146|147|P|more difficult for your body to respond to physical stress.||
0146|148|P|Before having surgery or emergency treatment, or if you get a||
0146|149|P|serious illness/injury, tell your doctor or dentist that you are||
0146|150|P|using this medication or have used this medication within the||
0146|151|P|past 12 months. Tell your doctor right away if you develop||
0146|152|P|unusual/extreme tiredness or weight loss. If you will be using||
0146|153|P|this medication for a long time, carry a warning card or medical||
0146|154|P|ID bracelet that identifies your use of this medication.||
0146|155|P|   This medication may mask signs of infection. It can make you||
0146|156|P|more likely to get infections or may make current infections||
0146|157|P|worse. Stay away from anyone who has an infection that may easily||
0146|158|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0146|159|P|doctor if you have been exposed to an infection or for more||
0146|160|P|details.||
0146|161|P|   Tell your health care professional that you are using||
0146|162|P|triamcinolone before having any immunizations, vaccinations, or||
0146|163|P|skin tests. Avoid contact with people who have recently received||
0146|164|P|live vaccines (such as flu vaccine inhaled through the nose).||
0146|165|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0146|166|P|while using this medicine may increase your risk for stomach||
0146|167|P|bleeding. Limit alcoholic beverages.||
0146|168|P|   Older adults may be more sensitive to the side effects of this||
0146|169|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
0146|170|P|mental/mood changes (such as confusion).||
0146|171|P|   This medication may slow down a child's growth if used for a||
0146|172|P|long time. Consult the doctor or pharmacist for more details. See||
0146|173|P|the doctor regularly so your child's height and growth can be||
0146|174|P|checked.||
0146|175|P|   Injecting this medication into a muscle is not recommended for||
0146|176|P|children younger than six years. Consult your doctor for more||
0146|177|P|details.||
0146|178|P|   During pregnancy, this medication should be used only when||
0146|179|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
0146|180|P|risks and benefits with your doctor. Infants born to mothers who||
0146|181|P|use corticosteroid medications for a long time may have hormone||
0146|182|P|problems. Tell your doctor right away if you notice symptoms such||
0146|183|P|as nausea/vomiting that doesn't stop, severe diarrhea, or||
0146|184|P|weakness in your newborn.||
0146|185|P|   It is unknown if this medication passes into breast milk.||
0146|186|P|Consult your doctor before breastfeeding.||
0146|187|B|||
0146|188|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0146|189|I|medications work or increase your risk for serious side effects.||
0146|190|I|This document does not contain all possible drug interactions.||
0146|191|I|Keep a list of all the products you use (including||
0146|192|I|prescription/nonprescription drugs and herbal products) and share||
0146|193|I|it with your doctor and pharmacist. Do not start, stop, or change||
0146|194|I|the dosage of any medicines without your doctor's approval.||
0146|195|I|   Some products that may interact with this drug are:||
0146|196|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
0146|197|I|cause bleeding/bruising (including antiplatelet drugs such as||
0146|198|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
0146|199|I|such as warfarin/dabigatran).||
0146|200|I|   Aspirin can increase the risk of bleeding when used with this||
0146|201|I|medication. However, if your doctor has told you to take low-dose||
0146|202|I|aspirin to prevent heart attack or stroke (usually 81-162||
0146|203|I|milligrams a day), you should keep taking the aspirin unless your||
0146|204|I|doctor tells you not to. Ask your doctor or pharmacist for more||
0146|205|I|details.||
0146|206|I|   This medication may interfere with certain lab tests (such as||
0146|207|I|skin tests), possibly causing false test results. Make sure lab||
0146|208|I|personnel and all your doctors know you use this drug.||
0146|209|B|||
0146|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0146|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0146|212|O|poison control center right away. US residents can call||
0146|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0146|214|B|||
0146|215|N|NOTES:  Do not share this medication with others.||
0146|216|N|   Lab and/or medical tests (such as blood counts, blood||
0146|217|N|glucose/mineral levels, blood pressure, bone density tests,||
0146|218|N|height/weight measurements, eye exams, x-rays) should be done||
0146|219|N|while you are using this medication. Keep all medical and lab||
0146|220|N|appointments. Consult your doctor for more details.||
0146|221|N|   This medication may cause bone loss (osteoporosis) when used||
0146|222|N|for a long time. Lifestyle changes that may help reduce the risk||
0146|223|N|of bone problems include doing weight-bearing exercise, stopping||
0146|224|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
0146|225|N|D. Talk to your doctor for more details.||
0146|226|N|   If you use this medication for prolonged periods, you should||
0146|227|N|wear or carry identification stating that you are using it.||
0146|228|B|||
0146|229|D|MISSED DOSE:  This medication should be used as scheduled. If you||
0146|230|D|miss a dose, contact your doctor or pharmacist for instructions.||
0146|231|D|Do not double the dose to catch up.||
0146|232|B|||
0146|233|R|STORAGE:  Different brands of this medication have different||
0146|234|R|storage needs. Check the product package for instructions on how||
0146|235|R|to store your brand, or ask your pharmacist. Keep all medications||
0146|236|R|away from children and pets.||
0146|237|R|   Do not flush medications down the toilet or pour them into a||
0146|238|R|drain unless instructed to do so. Properly discard this product||
0146|239|R|when it is expired or no longer needed. Consult your pharmacist||
0146|240|R|or local waste disposal company.||
0146|241|B|||
0146|242|A|Information last revised September 2025.||
0146|243|A|Copyright(c) 2025 First Databank, Inc.||
0146|244|B|||
0147|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0147|002|Z|does NOT have all possible information about this product. This||
0147|003|Z|information does not assure that this product is safe, effective,||
0147|004|Z|or appropriate for you. This information is not individual||
0147|005|Z|medical advice and does not substitute for the advice of your||
0147|006|Z|health care professional. Always ask your health care||
0147|007|Z|professional for complete information about this product and your||
0147|008|Z|specific health needs.||
0147|009|B|||
0147|010|T|MISOPROSTOL - ORAL||
0147|011|F|(MYE-soe-PROS-tol)||
0147|012|B|||
0147|013|C|COMMON BRAND NAME(S): Cytotec||
0147|014|B|||
0147|015|W|WARNING:  Do not take this medication if you think that you may||
0147|016|W|be pregnant. It may cause a pregnancy to end, premature birth, or||
0147|017|W|birth defects. In rare cases, serious complications (such as||
0147|018|W|uterine rupture) have occurred when misoprostol was used to start||
0147|019|W|labor or end a pregnancy. These complications have resulted in||
0147|020|W|harm to the unborn baby and mother. The risk for uterine rupture||
0147|021|W|increases as your pregnancy advances and if you had prior uterine||
0147|022|W|surgery (including Cesarean delivery) or if you had five or more||
0147|023|W|previous pregnancies.||
0147|024|W|   Avoid pregnancy while taking misoprostol and for at least one||
0147|025|W|month or one completed menstrual cycle after you have stopped||
0147|026|W|treatment. If you become pregnant while taking misoprostol,||
0147|027|W|contact your doctor right away.||
0147|028|W|   If you are pregnant, do not take this medication to reduce the||
0147|029|W|risk of stomach ulcers due to aspirin or other related drugs||
0147|030|W|(non-steroidal anti-inflammatory drugs-NSAIDs such as ibuprofen).||
0147|031|W|Also, if you are of childbearing age, do not use this drug to||
0147|032|W|reduce the risk of ulcers from NSAIDs unless you are at high risk||
0147|033|W|of having an ulcer or ulcer complications.||
0147|034|W|   Female patients must meet the following four requirements in||
0147|035|W|order to use this drug: 1) test negative for pregnancy within two||
0147|036|W|weeks before starting treatment; 2) use effective birth control||
0147|037|W|to prevent pregnancy; 3) receive oral and written warnings on the||
0147|038|W|dangers of using misoprostol while of childbearing age and the||
0147|039|W|risks of possible birth control failure; 4) start taking||
0147|040|W|misoprostol only on the second or third day of the next normal||
0147|041|W|menstrual period.||
0147|042|W|   This medication must not be shared with others.||
0147|043|B|||
0147|044|U|USES:  This medication is used to prevent stomach ulcers while||
0147|045|U|you take NSAIDs (such as aspirin, ibuprofen, naproxen),||
0147|046|U|especially if you are at risk for developing ulcers or have a||
0147|047|U|history of ulcers. Misoprostol helps to decrease your risk of||
0147|048|U|serious ulcer complications such as bleeding. This medication||
0147|049|U|protects your stomach lining by lowering the amount of acid that||
0147|050|U|comes in contact with it.||
0147|051|U|   This medication is also used in combination with another drug||
0147|052|U|(mifepristone) to end a pregnancy.||
0147|053|B|||
0147|054|V|OTHER USES:  This section contains uses of this drug that are not||
0147|055|V|listed in the approved professional labeling for the drug but||
0147|056|V|that may be prescribed by your health care professional. Use this||
0147|057|V|drug for a condition that is listed in this section only if it||
0147|058|V|has been so prescribed by your health care professional.||
0147|059|V|   This drug may also be used in the hospital to assist with||
0147|060|V|childbirth, only at the time of delivery (such as cervical||
0147|061|V|ripening, induction of labor) and for severe bleeding after||
0147|062|V|delivery. Discuss the risks and benefits with your doctor. When||
0147|063|V|misoprostol is used vaginally for these purposes, it works by||
0147|064|V|causing the womb muscles to contract.||
0147|065|B|||
0147|066|H|HOW TO USE:  This medicine comes with a patient information||
0147|067|H|leaflet. Read it carefully. If you have any questions about this||
0147|068|H|drug, ask your doctor, nurse, or pharmacist.||
0147|069|H|   The dosage is based on your medical condition and response to||
0147|070|H|treatment.||
0147|071|H|   If you are taking this drug to prevent stomach ulcers, take it||
0147|072|H|by mouth as directed by your doctor, usually four times a day.||
0147|073|H|Take it after meals and at bedtime to minimize diarrhea.||
0147|074|H|   If you are taking this medication to end a pregnancy, take it||
0147|075|H|by mouth exactly as directed by your doctor.||
0147|076|H|   If you are using this medication to start labor, your||
0147|077|H|healthcare professional will insert it into your vagina.||
0147|078|H|   Avoid taking antacids that contain magnesium while using||
0147|079|H|misoprostol because they may make the diarrhea it causes worse.||
0147|080|H|If you need an antacid, consult your doctor or pharmacist to help||
0147|081|H|you choose a product.||
0147|082|H|   For ulcer prevention, continue to take this drug for as long||
0147|083|H|as you take NSAIDs. Use this medication regularly in order to get||
0147|084|H|the most benefit from it. Remember to use it at the same times||
0147|085|H|each day.||
0147|086|H|   Tell your doctor if your condition lasts or gets worse.||
0147|087|B|||
0147|088|S|SIDE EFFECTS:  Nausea or stomach cramps may occur. If any of||
0147|089|S|these effects last or get worse, tell your doctor or pharmacist||
0147|090|S|promptly.||
0147|091|S|   Remember that this medication has been prescribed because your||
0147|092|S|doctor has judged that the benefit to you is greater than the||
0147|093|S|risk of side effects. Many people using this medication do not||
0147|094|S|have serious side effects.||
0147|095|S|   Diarrhea is common with misoprostol and usually occurs about||
0147|096|S|two weeks after you start taking it, and lasts for about a week.||
0147|097|S|Be sure to keep up your intake of fluids and||
0147|098|S|minerals/electrolytes to prevent dehydration. Diarrhea that||
0147|099|S|doesn't stop may sometimes lead to a large loss of your body's||
0147|100|S|water and minerals. Tell your doctor right away if you develop||
0147|101|S|any of these serious signs of dehydration and mineral imbalance:||
0147|102|S|dizziness, decreased urination, mental/mood changes, muscle||
0147|103|S|weakness, slow/irregular heartbeat.||
0147|104|S|   Tell your doctor right away if you have any serious side||
0147|105|S|effects, including: menstrual problems or irregularities,||
0147|106|S|unusual/heavy vaginal bleeding.||
0147|107|S|   A very serious allergic reaction to this drug is rare.||
0147|108|S|However, get medical help right away if you notice any symptoms||
0147|109|S|of a serious allergic reaction, including: rash, itching/swelling||
0147|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0147|111|S|breathing.||
0147|112|S|   This is not a complete list of possible side effects. If you||
0147|113|S|notice other effects not listed above, contact your doctor or||
0147|114|S|pharmacist.||
0147|115|S|   In the US -||
0147|116|S|   Call your doctor for medical advice about side effects. You||
0147|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0147|118|S|www.fda.gov/medwatch.||
0147|119|S|   In Canada - Call your doctor for medical advice about side||
0147|120|S|effects. You may report side effects to Health Canada at||
0147|121|S|1-866-234-2345.||
0147|122|B|||
0147|123|P|PRECAUTIONS:  Before taking misoprostol, tell your doctor or||
0147|124|P|pharmacist if you are allergic to it; or if you have any other||
0147|125|P|allergies. This product may contain inactive ingredients, which||
0147|126|P|can cause allergic reactions or other problems. Talk to your||
0147|127|P|pharmacist for more details.||
0147|128|P|   Before using this medication, tell your doctor or pharmacist||
0147|129|P|your medical history, especially of: stomach/intestinal disease||
0147|130|P|(such as inflammatory bowel disease).||
0147|131|P|   Daily use of alcohol and tobacco may increase your risk for||
0147|132|P|stomach bleeding. Limit alcohol beverages and stop smoking.||
0147|133|P|Consult your doctor or pharmacist for more information.||
0147|134|P|   If you are taking this medication in combination with||
0147|135|P|mifepristone to end a pregnancy, rarely the pregnancy may not||
0147|136|P|end. It is very important for you to be closely monitored by your||
0147|137|P|doctor and to keep your scheduled appointments to follow your||
0147|138|P|progress. Be sure to have clear instructions from your doctor||
0147|139|P|about who to call and what to do in case of an emergency. Expect||
0147|140|P|vaginal bleeding after you take the combined medicine, however||
0147|141|P|tell your doctor right away if you develop any unlikely symptoms||
0147|142|P|such as severe/prolonged vaginal bleeding, signs of infection||
0147|143|P|(including fever, chills), or fainting.||
0147|144|P|   This drug must not be used during pregnancy to prevent stomach||
0147|145|P|ulcers because of possible harm to an unborn baby (see also||
0147|146|P|Warnings). If you are of childbearing age, use effective birth||
0147|147|P|control methods while taking misoprostol and for at least one||
0147|148|P|month or one completed menstrual cycle after you stop taking it.||
0147|149|P|If you become pregnant or think you may be pregnant, inform your||
0147|150|P|doctor right away.||
0147|151|P|   This medication passes into breast milk. However, this drug is||
0147|152|P|unlikely to harm a nursing infant. Consult your doctor before||
0147|153|P|breastfeeding.||
0147|154|B|||
0147|155|I|DRUG INTERACTIONS:  See also the How to Use section.||
0147|156|I|   Drug interactions may change how your medications work or||
0147|157|I|increase your risk for serious side effects. This document does||
0147|158|I|not contain all possible drug interactions. Keep a list of all||
0147|159|I|the products you use (including prescription/nonprescription||
0147|160|I|drugs and herbal products) and share it with your doctor and||
0147|161|I|pharmacist. Do not start, stop, or change the dosage of any||
0147|162|I|medicines without your doctor's approval.||
0147|163|B|||
0147|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0147|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0147|166|O|poison control center right away. US residents can call||
0147|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0147|168|O|Symptoms of overdose may include: severe drowsiness, seizures,||
0147|169|O|severe dizziness, slow/irregular heartbeats.||
0147|170|B|||
0147|171|N|NOTES:  Do not share this medication with others.||
0147|172|B|||
0147|173|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0147|174|D|If it is near the time of the next dose, skip the missed dose.||
0147|175|D|Use your next dose at the regular time. Do not double the dose to||
0147|176|D|catch up.||
0147|177|B|||
0147|178|R|STORAGE:  Store at room temperature away from light and moisture.||
0147|179|R|Do not store in the bathroom. Keep all medications away from||
0147|180|R|children and pets.||
0147|181|R|   Do not flush medications down the toilet or pour them into a||
0147|182|R|drain unless instructed to do so. Properly discard this product||
0147|183|R|when it is expired or no longer needed. Consult your pharmacist||
0147|184|R|or local waste disposal company.||
0147|185|B|||
0147|186|A|Information last revised April 2025.||
0147|187|A|Copyright(c) 2025 First Databank, Inc.||
0147|188|B|||
0150|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0150|002|Z|does NOT have all possible information about this product. This||
0150|003|Z|information does not assure that this product is safe, effective,||
0150|004|Z|or appropriate for you. This information is not individual||
0150|005|Z|medical advice and does not substitute for the advice of your||
0150|006|Z|health care professional. Always ask your health care||
0150|007|Z|professional for complete information about this product and your||
0150|008|Z|specific health needs.||
0150|009|B|||
0150|010|T|AZTREONAM - INJECTION||
0150|011|F|(az-TREE-oh-nam)||
0150|012|B|||
0150|013|C|COMMON BRAND NAME(S): Azactam||
0150|014|B|||
0150|015|U|USES:  Aztreonam is used to treat a wide variety of bacterial||
0150|016|U|infections. This medication is an antibiotic that works by||
0150|017|U|stopping the growth of bacteria.||
0150|018|B|||
0150|019|H|HOW TO USE:  This medication is usually given by injection into a||
0150|020|H|vein or a muscle as directed by your doctor. The dosage is based||
0150|021|H|on your medical condition and response to treatment.||
0150|022|H|   If you are giving this medication to yourself at home, learn||
0150|023|H|all preparation and usage instructions from your health care||
0150|024|H|professional. Before using, check this product for particles or||
0150|025|H|discoloration. If either is present, do not use the liquid. Learn||
0150|026|H|how to store and discard medical supplies safely.||
0150|027|H|   For the best effect, use this antibiotic at evenly spaced||
0150|028|H|times. To help you remember, use this medication at the same||
0150|029|H|time(s) every day.||
0150|030|H|   Continue to use this medication until the full prescribed||
0150|031|H|amount is finished, even if symptoms disappear after a few days.||
0150|032|H|Stopping the medication too early may result in a return of the||
0150|033|H|infection.||
0150|034|H|   Tell your doctor if your condition lasts or gets worse.||
0150|035|B|||
0150|036|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, dizziness, headache,||
0150|037|S|blurred vision, or redness/discomfort/pain/swelling at the||
0150|038|S|injection site may occur. If any of these effects last or get||
0150|039|S|worse, notify your doctor or pharmacist promptly.||
0150|040|S|   Remember that this medication has been prescribed because your||
0150|041|S|doctor has judged that the benefit to you is greater than the||
0150|042|S|risk of side effects. Many people using this medication do not||
0150|043|S|have serious side effects.||
0150|044|S|   Tell your doctor right away if you have any serious side||
0150|045|S|effects, including: fast/irregular heartbeat, confusion, easy||
0150|046|S|bruising/bleeding, ringing in the ears, seizures, chest pain,||
0150|047|S|signs of liver disease (such as nausea/vomiting that doesn't||
0150|048|S|stop, stomach/abdominal pain, yellowing eyes/skin, dark urine),||
0150|049|S|unusual tiredness, signs of ongoing infection (such as fever,||
0150|050|S|sore throat).||
0150|051|S|   This medication may rarely cause a severe intestinal condition||
0150|052|S|due to a bacteria called C. difficile. This condition may occur||
0150|053|S|during treatment or weeks to months after treatment has stopped.||
0150|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0150|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0150|056|S|stool..||
0150|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0150|058|S|products because they may make symptoms worse.||
0150|059|S|   Use of this medication for prolonged or repeated periods may||
0150|060|S|result in oral thrush or a new vaginal yeast infection (oral or||
0150|061|S|vaginal fungal infection), or a new type of bacterial infection.||
0150|062|S|Contact your doctor if you notice white patches in your mouth, a||
0150|063|S|change in vaginal discharge, or other new symptoms.||
0150|064|S|   A very serious allergic reaction to this drug is rare.||
0150|065|S|However, get medical help right away if you notice any symptoms||
0150|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0150|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0150|068|S|breathing.||
0150|069|S|   This is not a complete list of possible side effects. If you||
0150|070|S|notice other effects not listed above, contact your doctor or||
0150|071|S|pharmacist.||
0150|072|S|   In the US -||
0150|073|S|   Call your doctor for medical advice about side effects. You||
0150|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0150|075|S|www.fda.gov/medwatch.||
0150|076|S|   In Canada - Call your doctor for medical advice about side||
0150|077|S|effects. You may report side effects to Health Canada at||
0150|078|S|1-866-234-2345.||
0150|079|B|||
0150|080|P|PRECAUTIONS:  Before using aztreonam, tell your doctor or||
0150|081|P|pharmacist if you are allergic to it; or to penicillins,||
0150|082|P|cephalosporins, or certain other antibiotics (such as imipenem,||
0150|083|P|meropenem); or if you have any other allergies. This product may||
0150|084|P|contain inactive ingredients, which can cause allergic reactions||
0150|085|P|or other problems. Talk to your pharmacist for more details.||
0150|086|P|   Before using this medication, tell your doctor or pharmacist||
0150|087|P|your medical history, especially of: kidney disease, liver||
0150|088|P|disease.||
0150|089|P|   This drug may rarely make you dizzy. Alcohol or marijuana||
0150|090|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
0150|091|P|or do anything that needs alertness until you can do it safely.||
0150|092|P|Limit alcoholic beverages. Talk to your doctor if you are using||
0150|093|P|marijuana (cannabis).||
0150|094|P|   Aztreonam may cause live bacterial vaccines (such as typhoid||
0150|095|P|vaccine) to not work well. Tell your health care professional||
0150|096|P|that you are using aztreonam before having any||
0150|097|P|immunizations/vaccinations.||
0150|098|P|   Before having surgery, tell your doctor or dentist about all||
0150|099|P|the products you use (including prescription drugs,||
0150|100|P|nonprescription drugs, and herbal products).||
0150|101|P|   During pregnancy, this medication should be used only when||
0150|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0150|103|P|   This medication passes into breast milk, but is unlikely to||
0150|104|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0150|105|B|||
0150|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0150|107|I|medications work or increase your risk for serious side effects.||
0150|108|I|This document does not contain all possible drug interactions.||
0150|109|I|Keep a list of all the products you use (including||
0150|110|I|prescription/nonprescription drugs and herbal products) and share||
0150|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0150|112|I|the dosage of any medicines without your doctor's approval.||
0150|113|I|   Some products that may interact with this drug include:||
0150|114|I|cefoxitin, imipenem.||
0150|115|I|   This medication may interfere with certain lab tests (such as||
0150|116|I|certain diabetic urine tests), possibly causing false test||
0150|117|I|results. Make sure lab personnel and all your doctors know you||
0150|118|I|use this drug.||
0150|119|B|||
0150|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0150|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0150|122|O|poison control center right away. US residents can call||
0150|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0150|124|B|||
0150|125|N|NOTES:  Lab and/or medical tests may be done while you are using||
0150|126|N|this medication. Keep all medical and lab appointments. Consult||
0150|127|N|your doctor for more details.||
0150|128|B|||
0150|129|D|MISSED DOSE:  It is important to get each dose of this medication||
0150|130|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0150|131|D|right away for a new dosing schedule. Do not double the dose to||
0150|132|D|catch up.||
0150|133|B|||
0150|134|R|STORAGE:  Consult the product instructions and your pharmacist||
0150|135|R|for storage details. Keep all medications away from children and||
0150|136|R|pets.||
0150|137|R|   Do not flush medications down the toilet or pour them into a||
0150|138|R|drain unless instructed to do so. Properly discard this product||
0150|139|R|when it is expired or no longer needed. Consult your pharmacist||
0150|140|R|or local waste disposal company.||
0150|141|B|||
0150|142|A|Information last revised November 2024.||
0150|143|A|Copyright(c) 2025 First Databank, Inc.||
0150|144|B|||
0151|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0151|002|Z|does NOT have all possible information about this product. This||
0151|003|Z|information does not assure that this product is safe, effective,||
0151|004|Z|or appropriate for you. This information is not individual||
0151|005|Z|medical advice and does not substitute for the advice of your||
0151|006|Z|health care professional. Always ask your health care||
0151|007|Z|professional for complete information about this product and your||
0151|008|Z|specific health needs.||
0151|009|B|||
0151|010|T|IMIPENEM/CILASTATIN - INJECTION||
0151|011|F|(IM-i-PEN-em/SYE-la-STAT-in)||
0151|012|B|||
0151|013|C|COMMON BRAND NAME(S): Primaxin||
0151|014|B|||
0151|015|U|USES:  This medication is used to treat a wide variety of||
0151|016|U|bacterial infections. This medication is known as a||
0151|017|U|carbapenem-type antibiotic. It works by stopping the growth of||
0151|018|U|bacteria.||
0151|019|B|||
0151|020|H|HOW TO USE:  This medication is given by injection into a muscle||
0151|021|H|or vein as directed by your doctor, usually every 6 to 8 hours.||
0151|022|H|The dosage is based on your medical condition and response to||
0151|023|H|treatment.||
0151|024|H|   If you are giving this medication to yourself at home, learn||
0151|025|H|all preparation and usage instructions from your health care||
0151|026|H|professional. Before using, check this product for particles or||
0151|027|H|discoloration. If either is present, do not use the liquid. Learn||
0151|028|H|how to store and discard medical supplies safely.||
0151|029|H|   For the best effect, use this antibiotic at evenly spaced||
0151|030|H|times. To help you remember, use this medication at the same||
0151|031|H|time(s) every day.||
0151|032|H|   Continue to use this medication until the full prescribed||
0151|033|H|treatment period is finished, even if symptoms disappear after a||
0151|034|H|few days. Stopping the medication too early may result in a||
0151|035|H|return of the infection.||
0151|036|H|   Tell your doctor if your condition lasts or gets worse.||
0151|037|B|||
0151|038|S|SIDE EFFECTS:  Swelling, redness, pain, or soreness at the||
0151|039|S|injection site may occur. This medication may also rarely cause||
0151|040|S|upset stomach, nausea, vomiting, or diarrhea. If any of these||
0151|041|S|effects last or get worse, tell your doctor or pharmacist||
0151|042|S|promptly.||
0151|043|S|   Remember that this medication has been prescribed because your||
0151|044|S|doctor has judged that the benefit to you is greater than the||
0151|045|S|risk of side effects. Many people using this medication do not||
0151|046|S|have serious side effects.||
0151|047|S|   Tell your doctor right away if you have any serious side||
0151|048|S|effects, including: sore throat/fever that doesn't go away, dark||
0151|049|S|urine, easy bruising/bleeding, hearing changes (such as decreased||
0151|050|S|hearing, ringing in the ears), mental/mood changes (such as||
0151|051|S|confusion, hallucinations), tingling hands/feet, yellowing||
0151|052|S|eyes/skin, muscle twitching/spasms.||
0151|053|S|   Get medical help right away if you have any very serious side||
0151|054|S|effects, including: seizures, unusual weakness.||
0151|055|S|   This medication may rarely cause a severe intestinal condition||
0151|056|S|due to a bacteria called C. difficile. This condition may occur||
0151|057|S|during treatment or weeks to months after treatment has stopped.||
0151|058|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0151|059|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0151|060|S|stool.||
0151|061|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0151|062|S|products because they may make symptoms worse.||
0151|063|S|   Use of this medication for prolonged or repeated periods may||
0151|064|S|result in oral thrush or a new vaginal yeast infection. Contact||
0151|065|S|your doctor if you notice white patches in your mouth, a change||
0151|066|S|in vaginal discharge, or other new symptoms.||
0151|067|S|   A very serious allergic reaction to this drug is rare.||
0151|068|S|However, get medical help right away if you notice any symptoms||
0151|069|S|of a serious allergic reaction, including: rash, itching/swelling||
0151|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0151|071|S|breathing.||
0151|072|S|   This is not a complete list of possible side effects. If you||
0151|073|S|notice other effects not listed above, contact your doctor or||
0151|074|S|pharmacist.||
0151|075|S|   In the US -||
0151|076|S|   Call your doctor for medical advice about side effects. You||
0151|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0151|078|S|www.fda.gov/medwatch.||
0151|079|S|   In Canada - Call your doctor for medical advice about side||
0151|080|S|effects. You may report side effects to Health Canada at||
0151|081|S|1-866-234-2345.||
0151|082|B|||
0151|083|P|PRECAUTIONS:  Before using imipenem with cilastatin, tell your||
0151|084|P|doctor or pharmacist if you are allergic to either of its||
0151|085|P|ingredients; or to other carbapenems (such as meropenem); or to||
0151|086|P|penicillins or cephalosporins; or if you have any other||
0151|087|P|allergies. This product may contain inactive ingredients, which||
0151|088|P|can cause allergic reactions or other problems. Talk to your||
0151|089|P|pharmacist for more details.||
0151|090|P|   Before using this medication, tell your doctor or pharmacist||
0151|091|P|your medical history, especially of: brain disorders (such as||
0151|092|P|seizures, head injury, tumor), kidney disease, liver disease,||
0151|093|P|stomach/intestinal diseases (such as colitis).||
0151|094|P|   This medication may cause live bacterial vaccines (such as||
0151|095|P|typhoid vaccine) to not work well. Tell your health care||
0151|096|P|professional that you are using this medication before having any||
0151|097|P|immunizations/vaccinations.||
0151|098|P|   Before having surgery, tell your doctor or dentist about all||
0151|099|P|the products you use (including prescription drugs,||
0151|100|P|nonprescription drugs, and herbal products).||
0151|101|P|   Older adults may be at greater risk for side effects while||
0151|102|P|using this drug.||
0151|103|P|   During pregnancy, this medication should be used only when||
0151|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
0151|105|P|   This medication passes into breast milk. Consult your doctor||
0151|106|P|before breastfeeding.||
0151|107|B|||
0151|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0151|109|I|medications work or increase your risk for serious side effects.||
0151|110|I|This document does not contain all possible drug interactions.||
0151|111|I|Keep a list of all the products you use (including||
0151|112|I|prescription/nonprescription drugs and herbal products) and share||
0151|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
0151|114|I|the dosage of any medicines without your doctor's approval.||
0151|115|I|   Some products that may interact with this drug include:||
0151|116|I|ganciclovir, valproic acid and related drugs (such as divalproex||
0151|117|I|sodium, sodium valproate).||
0151|118|I|   This medication may interfere with certain lab tests (such as||
0151|119|I|urine glucose), possibly causing false test results. Make sure||
0151|120|I|lab personnel and all your doctors know you use this drug.||
0151|121|B|||
0151|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0151|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0151|124|O|poison control center right away. US residents can call||
0151|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0151|126|O|Symptoms of overdose may include: seizures.||
0151|127|B|||
0151|128|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0151|129|N|kidney/liver function) may be done while you are using this||
0151|130|N|medication. Keep all medical and lab appointments. Consult your||
0151|131|N|doctor for more details.||
0151|132|B|||
0151|133|D|MISSED DOSE:  It is important to get each dose of this medication||
0151|134|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0151|135|D|right away for a new dosing schedule. Do not double the dose to||
0151|136|D|catch up.||
0151|137|B|||
0151|138|R|STORAGE:  Consult the product instructions and your pharmacist||
0151|139|R|for storage details. Keep all medications away from children and||
0151|140|R|pets.||
0151|141|R|   Do not flush medications down the toilet or pour them into a||
0151|142|R|drain unless instructed to do so. Properly discard this product||
0151|143|R|when it is expired or no longer needed. Consult your pharmacist||
0151|144|R|or local waste disposal company.||
0151|145|B|||
0151|146|A|Information last revised January 2025.||
0151|147|A|Copyright(c) 2025 First Databank, Inc.||
0151|148|B|||
0152|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0152|002|Z|does NOT have all possible information about this product. This||
0152|003|Z|information does not assure that this product is safe, effective,||
0152|004|Z|or appropriate for you. This information is not individual||
0152|005|Z|medical advice and does not substitute for the advice of your||
0152|006|Z|health care professional. Always ask your health care||
0152|007|Z|professional for complete information about this product and your||
0152|008|Z|specific health needs.||
0152|009|B|||
0152|010|T|OXYBUTYNIN - ORAL||
0152|011|F|(OX-i-BUE-ti-nin)||
0152|012|B|||
0152|013|C|COMMON BRAND NAME(S): Ditropan||
0152|014|B|||
0152|015|U|USES:  Oxybutynin is used to treat certain bladder and urinary||
0152|016|U|conditions (such as overactive bladder). It relaxes the muscles||
0152|017|U|in the bladder to help decrease problems of urgency and frequent||
0152|018|U|urination. Oxybutynin belongs to a class of drugs known as||
0152|019|U|antispasmodics.||
0152|020|B|||
0152|021|H|HOW TO USE:  Take this medication by mouth with or without food||
0152|022|H|as directed by your doctor, usually 2 to 3 times a day. The||
0152|023|H|dosage and length of treatment is based on your medical condition||
0152|024|H|and response to treatment.||
0152|025|H|   If you are using the liquid form of this medication, carefully||
0152|026|H|measure the dose using a special measuring device/spoon. Do not||
0152|027|H|use a household spoon because you may not get the correct dose.||
0152|028|H|   Use this medication regularly in order to get the most benefit||
0152|029|H|from it. Remember to use it at the same times each day.||
0152|030|H|   Tell your doctor if your condition lasts or gets worse.||
0152|031|B|||
0152|032|S|SIDE EFFECTS:  Dry mouth, dizziness, drowsiness, blurred vision,||
0152|033|S|dry eyes, nausea, vomiting, upset stomach, stomach pain,||
0152|034|S|constipation, diarrhea, headache, unusual taste in mouth,||
0152|035|S|dry/flushed skin, and weakness may occur. If any of these effects||
0152|036|S|last or get worse, tell your doctor or pharmacist promptly.||
0152|037|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0152|038|S|chips, chew (sugarless) gum, drink water or use a saliva||
0152|039|S|substitute. To relieve dry eyes, use artificial tears or other||
0152|040|S|eye lubricants. Consult your pharmacist for further advice.||
0152|041|S|   To prevent constipation, eat dietary fiber, drink enough||
0152|042|S|water, and exercise. You may also need to take a laxative. Ask||
0152|043|S|your pharmacist which type of laxative is right for you.||
0152|044|S|   Remember that this medication has been prescribed because your||
0152|045|S|doctor has judged that the benefit to you is greater than the||
0152|046|S|risk of side effects. Many people using this medication do not||
0152|047|S|have serious side effects.||
0152|048|S|   Tell your doctor right away if you have any serious side||
0152|049|S|effects, including: decreased sexual activity, difficulty||
0152|050|S|urinating, fast/pounding heartbeat, signs of kidney infection||
0152|051|S|(such as burning/painful/frequent urination, lower back pain,||
0152|052|S|fever), mental/mood changes (such as confusion, hallucinations),||
0152|053|S|swelling of arms/legs/ankles/feet, vision problems (including eye||
0152|054|S|pain), seizures, stomach/intestinal blockage (such as||
0152|055|S|nausea/vomiting that doesn't stop, prolonged constipation).||
0152|056|S|   A very serious allergic reaction to this drug is rare.||
0152|057|S|However, get medical help right away if you notice any symptoms||
0152|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0152|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0152|060|S|breathing.||
0152|061|S|   This is not a complete list of possible side effects. If you||
0152|062|S|notice other effects not listed above, contact your doctor or||
0152|063|S|pharmacist.||
0152|064|S|   In the US -||
0152|065|S|   Call your doctor for medical advice about side effects. You||
0152|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0152|067|S|www.fda.gov/medwatch.||
0152|068|S|   In Canada - Call your doctor for medical advice about side||
0152|069|S|effects. You may report side effects to Health Canada at||
0152|070|S|1-866-234-2345.||
0152|071|B|||
0152|072|P|PRECAUTIONS:  Before taking oxybutynin, tell your doctor or||
0152|073|P|pharmacist if you are allergic to it; or if you have any other||
0152|074|P|allergies. This product may contain inactive ingredients, which||
0152|075|P|can cause allergic reactions or other problems. Talk to your||
0152|076|P|pharmacist for more details.||
0152|077|P|   Before using this medication, tell your doctor or pharmacist||
0152|078|P|your medical history, especially of: glaucoma, bladder disease||
0152|079|P|(such as bladder outflow blockage, urinary retention), certain||
0152|080|P|muscle disease (myasthenia gravis), heart disease (such as heart||
0152|081|P|failure, coronary artery disease, arrhythmias), high blood||
0152|082|P|pressure, liver disease, kidney disease, loss of mental abilities||
0152|083|P|(dementia), certain nervous system disorder (autonomic||
0152|084|P|neuropathy), enlarged prostate gland (benign prostatic||
0152|085|P|hypertrophy-BPH), stomach/intestinal disease (such as blockage,||
0152|086|P|paralytic ileus, acid reflux disease, hiatal hernia, ulcerative||
0152|087|P|colitis), overactive thyroid (hyperthyroidism), Parkinson's||
0152|088|P|disease.||
0152|089|P|   This drug may make you dizzy or drowsy or blur your vision.||
0152|090|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0152|091|P|drowsy. Do not drive, use machinery, or do anything that needs||
0152|092|P|alertness or clear vision until you can do it safely. Limit||
0152|093|P|alcoholic beverages. Talk to your doctor if you are using||
0152|094|P|marijuana (cannabis).||
0152|095|P|   Before having surgery, tell your doctor or dentist about all||
0152|096|P|the products you use (including prescription drugs,||
0152|097|P|nonprescription drugs, and herbal products).||
0152|098|P|   This drug may make you sweat less, making you more likely to||
0152|099|P|get heat stroke. Avoid doing things that may cause you to||
0152|100|P|overheat, such as hard work or exercise in hot weather, or using||
0152|101|P|hot tubs. When the weather is hot, drink a lot of fluids and||
0152|102|P|dress lightly. If you overheat, quickly look for a place to cool||
0152|103|P|down and rest. Get medical help right away if you have a fever||
0152|104|P|that does not go away, mental/mood changes, headache, or||
0152|105|P|dizziness.||
0152|106|P|   Older adults may be more sensitive to the side effects of this||
0152|107|P|drug, especially drowsiness, confusion, constipation, trouble||
0152|108|P|urinating. Drowsiness and confusion can increase the risk of||
0152|109|P|falling.||
0152|110|P|   During pregnancy, this medication should be used only when||
0152|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
0152|112|P|   It is unknown if this medication passes into breast milk.||
0152|113|P|Consult your doctor before breastfeeding.||
0152|114|B|||
0152|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0152|116|I|medications work or increase your risk for serious side effects.||
0152|117|I|This document does not contain all possible drug interactions.||
0152|118|I|Keep a list of all the products you use (including||
0152|119|I|prescription/nonprescription drugs and herbal products) and share||
0152|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
0152|121|I|the dosage of any medicines without your doctor's approval.||
0152|122|I|   Some products that may interact with this drug include:||
0152|123|I|pramlintide, drugs that can irritate the esophagus/stomach (such||
0152|124|I|as potassium tablets/capsules, oral bisphosphonates including||
0152|125|I|alendronate).||
0152|126|I|   Tell your doctor or pharmacist if you are taking other||
0152|127|I|products that cause drowsiness such as opioid pain or cough||
0152|128|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0152|129|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0152|130|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0152|131|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0152|132|I|diphenhydramine).||
0152|133|I|   Check the labels on all your medicines (such as allergy or||
0152|134|I|cough-and-cold products) because they may contain ingredients||
0152|135|I|that can cause drowsiness, constipation or blurred vision. Ask||
0152|136|I|your pharmacist about using those products safely.||
0152|137|B|||
0152|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0152|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0152|140|O|poison control center right away. US residents can call||
0152|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0152|142|O|Symptoms of overdose may include: delirium and paralysis.||
0152|143|B|||
0152|144|N|NOTES:  Do not share this medication with others.||
0152|145|B|||
0152|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0152|147|D|If it is near the time of the next dose, skip the missed dose.||
0152|148|D|Use your next dose at the regular time. Do not double the dose to||
0152|149|D|catch up.||
0152|150|B|||
0152|151|R|STORAGE:  Store at room temperature away from light and moisture.||
0152|152|R|Do not store in the bathroom. Keep all medications away from||
0152|153|R|children and pets.||
0152|154|R|   Do not flush medications down the toilet or pour them into a||
0152|155|R|drain unless instructed to do so. Properly discard this product||
0152|156|R|when it is expired or no longer needed. Consult your pharmacist||
0152|157|R|or local waste disposal company.||
0152|158|B|||
0152|159|A|Information last revised October 2025.||
0152|160|A|Copyright(c) 2025 First Databank, Inc.||
0152|161|B|||
0153|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0153|002|Z|does NOT have all possible information about this product. This||
0153|003|Z|information does not assure that this product is safe, effective,||
0153|004|Z|or appropriate for you. This information is not individual||
0153|005|Z|medical advice and does not substitute for the advice of your||
0153|006|Z|health care professional. Always ask your health care||
0153|007|Z|professional for complete information about this product and your||
0153|008|Z|specific health needs.||
0153|009|B|||
0153|010|T|PENTAMIDINE ISETHIONATE - INHALATION||
0153|011|F|(pen-TAM-i-deen EYE-se-THYE-oh-nate)||
0153|012|B|||
0153|013|C|COMMON BRAND NAME(S): Nebupent||
0153|014|B|||
0153|015|U|USES:  Pentamidine given by inhalation is used to prevent a||
0153|016|U|serious lung infection (Pneumocystis pneumonia-PCP) in people||
0153|017|U|with acquired immunodeficiency syndrome (AIDS). Pentamidine||
0153|018|U|belongs to a class of drugs known as antiprotozoals. It works by||
0153|019|U|killing the organism that causes the infection.||
0153|020|B|||
0153|021|H|HOW TO USE:  This medication is given by a health care||
0153|022|H|professional as directed by your doctor, usually once every 4||
0153|023|H|weeks. It is given using a special machine called a nebulizer||
0153|024|H|that changes the solution to a fine mist that you inhale. Each||
0153|025|H|treatment usually takes 30 to 45 minutes. You may also be given||
0153|026|H|another inhaled medication (such as albuterol) to help open your||
0153|027|H|airways before each treatment with pentamidine. Learn and follow||
0153|028|H|all instructions for the use of this medication and the||
0153|029|H|nebulizer. If you have any questions, ask your doctor,||
0153|030|H|pharmacist, or respiratory therapist.||
0153|031|H|   The dosage is based on your medical condition and response to||
0153|032|H|treatment.||
0153|033|H|   Use this medication regularly to get the most benefit from it.||
0153|034|H|To help you remember, mark your calendar with a reminder.||
0153|035|H|   Tell your doctor right away if you develop symptoms of||
0153|036|H|infection such as breathing problems, cough, or fever between||
0153|037|H|treatments.||
0153|038|B|||
0153|039|S|SIDE EFFECTS:  Cough, upset stomach, loss of appetite, nausea,||
0153|040|S|vomiting, diarrhea, dizziness, headache, burning feeling in the||
0153|041|S|throat, or unusual taste/dryness in the mouth may occur. If any||
0153|042|S|of these effects last or get worse, tell your doctor or||
0153|043|S|pharmacist promptly.||
0153|044|S|   Remember that this medication has been prescribed because your||
0153|045|S|doctor has judged that the benefit to you is greater than the||
0153|046|S|risk of side effects. Many people using this medication do not||
0153|047|S|have serious side effects.||
0153|048|S|   Tell your doctor or respiratory therapist right away if you||
0153|049|S|have any serious side effects, including: chest tightness,||
0153|050|S|breathing problems.||
0153|051|S|   Though very unlikely, inhaled pentamidine might be absorbed||
0153|052|S|into your body. Tell your doctor right away if any of these||
0153|053|S|serious side effects occur: abdominal pain, easy||
0153|054|S|bruising/bleeding, fast/irregular heartbeat, mental/mood changes||
0153|055|S|(such as confusion, hallucinations), signs of kidney problems||
0153|056|S|(such as change in the amount of urine), signs of anemia (such as||
0153|057|S|severe tiredness, bluish skin/nails), signs of low blood pressure||
0153|058|S|(such as severe dizziness, pale skin, fainting), signs of low||
0153|059|S|blood sugar (such as sudden sweating, shaking, fast heartbeat,||
0153|060|S|hunger), signs of high blood sugar (such as unusual increase in||
0153|061|S|thirst or urination), signs of infection (such as sore throat||
0153|062|S|that doesn't go away, fever, chills).||
0153|063|S|   A very serious allergic reaction to this drug is rare.||
0153|064|S|However, get medical help right away if you notice any symptoms||
0153|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0153|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0153|067|S|breathing.||
0153|068|S|   This is not a complete list of possible side effects. If you||
0153|069|S|notice other effects not listed above, contact your doctor or||
0153|070|S|pharmacist.||
0153|071|S|   In the US -||
0153|072|S|   Call your doctor for medical advice about side effects. You||
0153|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0153|074|S|www.fda.gov/medwatch.||
0153|075|S|   In Canada - Call your doctor for medical advice about side||
0153|076|S|effects. You may report side effects to Health Canada at||
0153|077|S|1-866-234-2345.||
0153|078|B|||
0153|079|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0153|080|P|pharmacist if you are allergic to it; or if you have any other||
0153|081|P|allergies. This product may contain inactive ingredients, which||
0153|082|P|can cause allergic reactions or other problems. Talk to your||
0153|083|P|pharmacist for more details.||
0153|084|P|   Before using this medication, tell your doctor, respiratory||
0153|085|P|therapist, or pharmacist your medical history, especially of:||
0153|086|P|bleeding/blood disorders, breathing problems (such as asthma),||
0153|087|P|diabetes, kidney disease, liver problems, smoking.||
0153|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0153|089|P|can make you more dizzy. Do not drive, use machinery, or do||
0153|090|P|anything that needs alertness until you can do it safely. Limit||
0153|091|P|alcoholic beverages. Talk to your doctor if you are using||
0153|092|P|marijuana (cannabis).||
0153|093|P|   Before having surgery, tell your doctor or dentist about all||
0153|094|P|the products you use (including prescription drugs,||
0153|095|P|nonprescription drugs, and herbal products).||
0153|096|P|   During pregnancy, this medication should be used only when||
0153|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
0153|098|P|   It is unknown if this medication passes into breast milk.||
0153|099|P|Consult your doctor before breastfeeding.||
0153|100|B|||
0153|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0153|102|I|medications work or increase your risk for serious side effects.||
0153|103|I|This document does not contain all possible drug interactions.||
0153|104|I|Keep a list of all the products you use (including||
0153|105|I|prescription/nonprescription drugs and herbal products) and share||
0153|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
0153|107|I|the dosage of any medicines without your doctor's approval.||
0153|108|B|||
0153|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0153|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0153|111|O|poison control center right away. US residents can call||
0153|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0153|113|B|||
0153|114|N|NOTES:  Do not share this medication with others.||
0153|115|N|   Keep all medical and lab appointments.||
0153|116|B|||
0153|117|D|MISSED DOSE:  It is important to get each dose of this medication||
0153|118|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0153|119|D|right away for a new dosing schedule.||
0153|120|B|||
0153|121|R|STORAGE:  Store at room temperature away from light. Use/discard||
0153|122|R|the mixed solution within 48 hours. Keep all medications away||
0153|123|R|from children and pets.||
0153|124|R|   Do not flush medications down the toilet or pour them into a||
0153|125|R|drain unless instructed to do so. Properly discard this product||
0153|126|R|when it is expired or no longer needed. Consult your pharmacist||
0153|127|R|or local waste disposal company.||
0153|128|B|||
0153|129|A|Information last revised October 2024.||
0153|130|A|Copyright(c) 2025 First Databank, Inc.||
0153|131|B|||
0154|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0154|002|Z|does NOT have all possible information about this product. This||
0154|003|Z|information does not assure that this product is safe, effective,||
0154|004|Z|or appropriate for you. This information is not individual||
0154|005|Z|medical advice and does not substitute for the advice of your||
0154|006|Z|health care professional. Always ask your health care||
0154|007|Z|professional for complete information about this product and your||
0154|008|Z|specific health needs.||
0154|009|B|||
0154|010|T|VANCOMYCIN - INJECTION||
0154|011|F|(VAN-koe-MYE-sin)||
0154|012|B|||
0154|013|C|COMMON BRAND NAME(S): Tyzavan, Vancocin||
0154|014|B|||
0154|015|U|USES:  Vancomycin is used to treat serious bacterial infections.||
0154|016|U|It is an antibiotic that works by stopping the growth of||
0154|017|U|bacteria.||
0154|018|B|||
0154|019|H|HOW TO USE:  This medication is usually given by injection into a||
0154|020|H|vein as directed by your doctor. Each dose should be injected||
0154|021|H|slowly over at least 1 hour. The dosage and length of treatment||
0154|022|H|are based on your medical condition, labs, weight, and response||
0154|023|H|to treatment.||
0154|024|H|   If you are using this medication at home, learn all||
0154|025|H|preparation and usage instructions from your health care||
0154|026|H|professional. Before using, check this product for particles or||
0154|027|H|discoloration. If either is present, do not use the liquid. Learn||
0154|028|H|how to store and discard medical supplies safely.||
0154|029|H|   If you are using the frozen mixed liquid, thaw the medication||
0154|030|H|at room temperature or in the refrigerator before using. Do not||
0154|031|H|thaw by putting in a water bath or microwave. After thawing,||
0154|032|H|shake well and squeeze the container to check for leaks. Discard||
0154|033|H|the solution if the container leaks. Do not freeze it again after||
0154|034|H|thawing.||
0154|035|H|   Infusion reactions may happen during the infusion of this drug||
0154|036|H|if this drug is injected too fast. Tell your doctor right away if||
0154|037|H|you have any symptoms of infusion reactions such as flushing of||
0154|038|H|the upper body, dizziness, or muscle pain/spasms of the chest and||
0154|039|H|back. Your doctor may slow down or stop your treatment for some||
0154|040|H|time.||
0154|041|H|   For the best effect, use this antibiotic at evenly spaced||
0154|042|H|times. To help you remember, use this medication at the same||
0154|043|H|times every day.||
0154|044|H|   Continue to use this medication until the full prescribed||
0154|045|H|amount is finished, even if symptoms disappear after a few days.||
0154|046|H|Stopping the medication too early may result in a return of the||
0154|047|H|infection.||
0154|048|H|   Tell your doctor if your condition lasts or gets worse.||
0154|049|B|||
0154|050|S|SIDE EFFECTS:  See also How to Use section.||
0154|051|S|   Pain, redness, and tenderness at the injection site may occur.||
0154|052|S|If any of these effects last or get worse, tell your doctor or||
0154|053|S|pharmacist promptly.||
0154|054|S|   Remember that this medication has been prescribed because your||
0154|055|S|doctor has judged that the benefit to you is greater than the||
0154|056|S|risk of side effects. Many people using this medication do not||
0154|057|S|have serious side effects.||
0154|058|S|   Tell your doctor right away if you have any serious side||
0154|059|S|effects, including: hearing problems (such as ringing in the||
0154|060|S|ears, hearing loss), signs of kidney problems (such as change in||
0154|061|S|the amount of urine), easy bleeding/bruising, vision changes||
0154|062|S|(such as blurred vision, decreased vision).||
0154|063|S|   This medication may rarely cause a severe intestinal condition||
0154|064|S|due to a bacteria called C. difficile. This condition may occur||
0154|065|S|during treatment or weeks to months after treatment has stopped.||
0154|066|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0154|067|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0154|068|S|stool.||
0154|069|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0154|070|S|products because they may make symptoms worse.||
0154|071|S|   Use of this medication for prolonged or repeated periods may||
0154|072|S|result in oral thrush or a new yeast infection. Contact your||
0154|073|S|doctor if you notice white patches in your mouth, a change in||
0154|074|S|vaginal discharge, or other new symptoms.||
0154|075|S|   A very serious allergic reaction to this drug is rare.||
0154|076|S|However, get medical help right away if you notice any symptoms||
0154|077|S|of a serious allergic reaction, including: fever that doesn't go||
0154|078|S|away, new or worsening lymph node swelling, rash,||
0154|079|S|itching/swelling (especially of the face/tongue/throat), severe||
0154|080|S|dizziness, trouble breathing.||
0154|081|S|   This is not a complete list of possible side effects. If you||
0154|082|S|notice other effects not listed above, contact your doctor or||
0154|083|S|pharmacist.||
0154|084|S|   In the US -||
0154|085|S|   Call your doctor for medical advice about side effects. You||
0154|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0154|087|S|www.fda.gov/medwatch.||
0154|088|S|   In Canada - Call your doctor for medical advice about side||
0154|089|S|effects. You may report side effects to Health Canada at||
0154|090|S|1-866-234-2345.||
0154|091|B|||
0154|092|P|PRECAUTIONS:  Before using vancomycin, tell your doctor or||
0154|093|P|pharmacist if you are allergic to it; or if you have any other||
0154|094|P|allergies. This product may contain inactive ingredients, which||
0154|095|P|can cause allergic reactions or other problems. Talk to your||
0154|096|P|pharmacist for more details.||
0154|097|P|   Before using this medication, tell your doctor or pharmacist||
0154|098|P|your medical history, especially of: kidney problems, hearing||
0154|099|P|problems, stomach/intestinal problems.||
0154|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0154|101|P|can make you more dizzy. Do not drive, use machinery, or do||
0154|102|P|anything that needs alertness until you can do it safely. Limit||
0154|103|P|alcoholic beverages. Talk to your doctor if you are using||
0154|104|P|marijuana (cannabis).||
0154|105|P|   Some brands of this medication contain sodium. Consult your||
0154|106|P|doctor or pharmacist if you are on a salt-restricted diet or if||
0154|107|P|you have a condition that could be worsened by an increase in||
0154|108|P|salt intake (such as heart failure).||
0154|109|P|   Vancomycin may cause live bacterial vaccines (such as typhoid||
0154|110|P|vaccine) to not work well. Tell your health care professional||
0154|111|P|that you are using vancomycin before having any||
0154|112|P|immunizations/vaccinations.||
0154|113|P|   Before having surgery, tell your doctor or dentist about all||
0154|114|P|the products you use (including prescription drugs,||
0154|115|P|nonprescription drugs, and herbal products).||
0154|116|P|   Children may be at greater risk for infusion reactions,||
0154|117|P|especially when this medication is injected too fast.||
0154|118|P|   Older adults may be at greater risk for kidney and hearing||
0154|119|P|problems while using this drug.||
0154|120|P|   During pregnancy, this medication should be used only when||
0154|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
0154|122|P|   This medication passes into breast milk. Consult your doctor||
0154|123|P|before breastfeeding.||
0154|124|B|||
0154|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0154|126|I|medications work or increase your risk for serious side effects.||
0154|127|I|This document does not contain all possible drug interactions.||
0154|128|I|Keep a list of all the products you use (including||
0154|129|I|prescription/nonprescription drugs and herbal products) and share||
0154|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
0154|131|I|the dosage of any medicines without your doctor's approval.||
0154|132|I|   A product that may interact with this drug is: cidofovir.||
0154|133|B|||
0154|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0154|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0154|136|O|poison control center right away. US residents can call||
0154|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0154|138|B|||
0154|139|N|NOTES:  Lab and/or medical tests (such as kidney function,||
0154|140|N|vancomycin blood levels, blood cultures, complete blood counts,||
0154|141|N|hearing tests) should be done while you are using this||
0154|142|N|medication. Keep all medical and lab appointments.||
0154|143|B|||
0154|144|D|MISSED DOSE:  It is important to get each dose of this medication||
0154|145|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0154|146|D|right away for a new dosing schedule. Do not double the dose to||
0154|147|D|catch up.||
0154|148|B|||
0154|149|R|STORAGE:  Consult the product instructions or your pharmacist for||
0154|150|R|storage details. Keep all medications away from children and||
0154|151|R|pets.||
0154|152|R|   Do not flush medications down the toilet or pour them into a||
0154|153|R|drain unless instructed to do so. Properly discard this product||
0154|154|R|when it is expired or no longer needed. Consult your pharmacist||
0154|155|R|or local waste disposal company.||
0154|156|B|||
0154|157|A|Information last revised December 2024.||
0154|158|A|Copyright(c) 2025 First Databank, Inc.||
0154|159|B|||
0155|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0155|002|Z|does NOT have all possible information about this product. This||
0155|003|Z|information does not assure that this product is safe, effective,||
0155|004|Z|or appropriate for you. This information is not individual||
0155|005|Z|medical advice and does not substitute for the advice of your||
0155|006|Z|health care professional. Always ask your health care||
0155|007|Z|professional for complete information about this product and your||
0155|008|Z|specific health needs.||
0155|009|B|||
0155|010|T|BUPROPION - ORAL||
0155|011|F|(bue-PROE-pee-on)||
0155|012|B|||
0155|013|C|COMMON BRAND NAME(S): Wellbutrin||
0155|014|B|||
0155|015|W|WARNING:  Bupropion is an antidepressant used to treat a variety||
0155|016|W|of conditions, including depression, other mental/mood disorders,||
0155|017|W|and smoking cessation. Antidepressants can help prevent suicidal||
0155|018|W|thoughts/attempts and provide other important benefits. However,||
0155|019|W|studies have shown that a small number of people (especially||
0155|020|W|people younger than 25) who take antidepressants for any||
0155|021|W|condition may experience new or worsening depression, other||
0155|022|W|mental/mood symptoms, or suicidal thoughts/attempts. It is very||
0155|023|W|important to talk with the doctor about the risks and benefits of||
0155|024|W|antidepressant medication, even if treatment is not for a||
0155|025|W|mental/mood condition.||
0155|026|W|   Tell the doctor right away if you notice new or worsening||
0155|027|W|depression/other psychiatric conditions, unusual behavior changes||
0155|028|W|(including possible suicidal thoughts/attempts), or other||
0155|029|W|mental/mood changes (including new/worsening anxiety, panic||
0155|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0155|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0155|032|W|especially watchful for these symptoms when a new antidepressant||
0155|033|W|is started or when the dose is changed.||
0155|034|W|   If you are using bupropion to quit smoking, stop taking||
0155|035|W|bupropion and contact your doctor right away if you experience||
0155|036|W|any of the symptoms listed above. Tell your doctor right away if||
0155|037|W|you have any of these symptoms after stopping treatment.||
0155|038|B|||
0155|039|U|USES:  This medication is used to treat depression. Bupropion||
0155|040|U|works by helping to restore the balance of certain natural||
0155|041|U|substances (dopamine, norepinephrine) in the brain.||
0155|042|B|||
0155|043|V|OTHER USES:  This section contains uses of this drug that are not||
0155|044|V|listed in the approved professional labeling for the drug but||
0155|045|V|that may be prescribed by your health care professional. Use this||
0155|046|V|drug for a condition that is listed in this section only if it||
0155|047|V|has been so prescribed by your health care professional.||
0155|048|V|   This drug may also be used for other mental/mood disorders||
0155|049|V|(such as attention deficit hyperactivity disorder-ADHD, seasonal||
0155|050|V|affective disorder, depressive phase of bipolar disorder). It may||
0155|051|V|be used to help people quit smoking by lessening cravings and||
0155|052|V|nicotine withdrawal. It may also be used to for binge eating||
0155|053|V|disorder (BED).||
0155|054|B|||
0155|055|H|HOW TO USE:  Read the Patient Information Leaflet and Medication||
0155|056|H|Guide available from your pharmacist before you start using||
0155|057|H|bupropion and each time you get a refill. Consult your doctor or||
0155|058|H|pharmacist if you have any questions.||
0155|059|H|   Take this medication by mouth with or without food as directed||
0155|060|H|by your doctor, usually three times daily. If stomach upset||
0155|061|H|occurs, you may take this drug with food. It is important to take||
0155|062|H|your doses at least 6 hours apart or as directed by your doctor||
0155|063|H|to decrease your risk of having a seizure.||
0155|064|H|   The manufacturer directs not to crush, cut, or chew the tablet||
0155|065|H|before taking it. However, many similar drugs (immediate-release||
0155|066|H|tablets) can be crushed, cut, or chewed. Follow your doctor's||
0155|067|H|directions on how to take this medication.||
0155|068|H|   Do not take more or less medication or take it more often than||
0155|069|H|prescribed. Taking more than the recommended dose of bupropion||
0155|070|H|may increase your risk of having a seizure.||
0155|071|H|   The dosage is based on your medical condition and response to||
0155|072|H|treatment. Your dose may be slowly increased to limit side||
0155|073|H|effects such as sleeplessness, and to decrease the risk of||
0155|074|H|seizures. To avoid trouble sleeping, do not take this medication||
0155|075|H|too close to bedtime. Let your doctor know if sleeplessness||
0155|076|H|becomes a problem.||
0155|077|H|   Use this medication regularly in order to get the most benefit||
0155|078|H|from it. To help you remember, use it at the same times each day.||
0155|079|H|   Do not stop taking this medication without consulting your||
0155|080|H|doctor. Some conditions may become worse when the drug is||
0155|081|H|suddenly stopped. Your dose may need to be gradually decreased.||
0155|082|H|   It may take 4 or more weeks before you notice the full benefit||
0155|083|H|of this drug. Continue to take this medication as directed by||
0155|084|H|your doctor even after you feel better. Tell your doctor if your||
0155|085|H|condition does not get better or if it gets worse.||
0155|086|B|||
0155|087|S|SIDE EFFECTS:  See also Warning section.||
0155|088|S|   Nausea, vomiting, dry mouth, headache, constipation, increased||
0155|089|S|sweating, joint aches, sore throat, blurred vision, strange taste||
0155|090|S|in the mouth, diarrhea, or dizziness may occur. If any of these||
0155|091|S|effects last or get worse, notify your doctor or pharmacist||
0155|092|S|promptly.||
0155|093|S|   Remember that this medication has been prescribed because your||
0155|094|S|doctor has judged that the benefit to you is greater than the||
0155|095|S|risk of side effects. Many people using this medication do not||
0155|096|S|have serious side effects.||
0155|097|S|   This medication may raise your blood pressure. Check your||
0155|098|S|blood pressure regularly and tell your doctor if the results are||
0155|099|S|high.||
0155|100|S|   Tell your doctor right away if you have any serious side||
0155|101|S|effects, including: chest pain, fainting, fast/pounding/irregular||
0155|102|S|heartbeat, hearing problems, ringing in the ears, severe||
0155|103|S|headache, mental/mood changes (such as agitation, anxiety,||
0155|104|S|confusion, hallucinations, memory loss), uncontrolled movements||
0155|105|S|(tremor), unusual weight loss or gain, muscle||
0155|106|S|pain/tenderness/weakness.||
0155|107|S|   Get medical help right away if you have any very serious side||
0155|108|S|effects, including: eye pain/swelling/redness, widened pupils,||
0155|109|S|vision changes (such as seeing rainbows around lights at night),||
0155|110|S|seizure.||
0155|111|S|   A very serious allergic reaction to this drug is rare.||
0155|112|S|However, get medical help right away if you notice any symptoms||
0155|113|S|of a serious allergic reaction, including: rash, itching/swelling||
0155|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0155|115|S|breathing.||
0155|116|S|   This is not a complete list of possible side effects. If you||
0155|117|S|notice other effects not listed above, contact your doctor or||
0155|118|S|pharmacist.||
0155|119|S|   In the US -||
0155|120|S|   Call your doctor for medical advice about side effects. You||
0155|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0155|122|S|www.fda.gov/medwatch.||
0155|123|S|   In Canada - Call your doctor for medical advice about side||
0155|124|S|effects. You may report side effects to Health Canada at||
0155|125|S|1-866-234-2345.||
0155|126|B|||
0155|127|P|PRECAUTIONS:  Before taking bupropion, tell your doctor or||
0155|128|P|pharmacist if you are allergic to it; or if you have any other||
0155|129|P|allergies. This product may contain inactive ingredients, which||
0155|130|P|can cause allergic reactions or other problems. Talk to your||
0155|131|P|pharmacist for more details.||
0155|132|P|   Before using this medication, tell your doctor or pharmacist||
0155|133|P|your medical history, especially of: seizures or conditions that||
0155|134|P|increase your risk of seizures (including brain/head injury,||
0155|135|P|brain tumors, arteriovenous malformation, eating disorders such||
0155|136|P|as bulimia/anorexia nervosa), alcohol/drug dependence (including||
0155|137|P|benzodiazepines, opioid pain medicines, cocaine and stimulants),||
0155|138|P|diabetes, heart disease (such as heart failure, high blood||
0155|139|P|pressure, recent heart attack), kidney problems, liver problems||
0155|140|P|(such as cirrhosis), personal or family history of psychiatric||
0155|141|P|disorder (such as bipolar/manic-depressive disorder), personal or||
0155|142|P|family history of suicide thoughts/attempts, personal or family||
0155|143|P|history of glaucoma (angle-closure type).||
0155|144|P|   This medication should not be used if you are suddenly||
0155|145|P|stopping regular use of sedatives (including benzodiazepines such||
0155|146|P|as lorazepam), drugs used to treat seizures, or alcohol. Doing so||
0155|147|P|may increase your risk of seizures.||
0155|148|P|   This drug may make you dizzy or affect your coordination.||
0155|149|P|Alcohol or marijuana (cannabis) can make you more dizzy or affect||
0155|150|P|your coordination. Do not drive, use machinery, or do anything||
0155|151|P|that needs alertness until you can do it safely. Avoid alcoholic||
0155|152|P|beverages. Alcohol can also increase your risk of seizures. Talk||
0155|153|P|to your doctor if you are using marijuana (cannabis).||
0155|154|P|   Older adults may be more sensitive to the side effects of this||
0155|155|P|drug, especially dizziness and memory loss. Dizziness can||
0155|156|P|increase the risk of falling.||
0155|157|P|   During pregnancy, this medication should be used only when||
0155|158|P|clearly needed. Since untreated mental/mood problems (such as||
0155|159|P|depression, seasonal affective disorder, bipolar disorder) can be||
0155|160|P|a serious condition, do not stop taking this medication unless||
0155|161|P|directed by your doctor. If you are planning pregnancy, become||
0155|162|P|pregnant, or think you may be pregnant, immediately discuss with||
0155|163|P|your doctor the benefits and risks of using this medication||
0155|164|P|during pregnancy.||
0155|165|P|   This drug passes into breast milk and may have undesirable||
0155|166|P|effects on a nursing infant. Consult your doctor before||
0155|167|P|breastfeeding.||
0155|168|B|||
0155|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0155|170|I|medications work or increase your risk for serious side effects.||
0155|171|I|This document does not contain all possible drug interactions.||
0155|172|I|Keep a list of all the products you use (including||
0155|173|I|prescription/nonprescription drugs and herbal products) and share||
0155|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
0155|175|I|the dosage of any medicines without your doctor's approval.||
0155|176|I|   Some products that may interact with this drug include:||
0155|177|I|codeine, pimozide, tamoxifen, thioridazine.||
0155|178|I|   Taking MAO inhibitors with this medication may cause a serious||
0155|179|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0155|180|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0155|181|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0155|182|I|selegiline, tranylcypromine) during treatment with this||
0155|183|I|medication. Most MAO inhibitors should also not be taken for two||
0155|184|I|weeks before and after treatment with this medication. Ask your||
0155|185|I|doctor when to start or stop taking this medication.||
0155|186|I|   This medication may interfere with certain medical/lab tests||
0155|187|I|(such as brain scan for Parkinson's disease, urine screening for||
0155|188|I|amphetamines), possibly causing false test results. Make sure lab||
0155|189|I|personnel and all your doctors know you use this drug.||
0155|190|B|||
0155|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0155|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0155|193|O|poison control center right away. US residents can call||
0155|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0155|195|O|Symptoms of overdose may include: seizures, hallucinations, fast||
0155|196|O|or slow heart rate, loss of consciousness.||
0155|197|B|||
0155|198|N|NOTES:  Do not share this medication with others.||
0155|199|N|   Lab and/or medical tests (such as blood pressure, liver||
0155|200|N|function) may be done while you are taking this medication. Keep||
0155|201|N|all medical and lab appointments. Consult your doctor for more||
0155|202|N|details.||
0155|203|B|||
0155|204|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
0155|205|D|next dose at the regular time. Do not double the dose to catch||
0155|206|D|up.||
0155|207|B|||
0155|208|R|STORAGE:  Store at room temperature away from light and moisture.||
0155|209|R|Bupropion tablets may have a strange odor. This is normal and the||
0155|210|R|medication is still okay to use. Do not store in the bathroom.||
0155|211|R|Keep all medications away from children and pets.||
0155|212|R|   Do not flush medications down the toilet or pour them into a||
0155|213|R|drain unless instructed to do so. Properly discard this product||
0155|214|R|when it is expired or no longer needed. Consult your pharmacist||
0155|215|R|or local waste disposal company.||
0155|216|B|||
0155|217|A|Information last revised February 2025.||
0155|218|A|Copyright(c) 2025 First Databank, Inc.||
0155|219|B|||
0156|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0156|002|Z|does NOT have all possible information about this product. This||
0156|003|Z|information does not assure that this product is safe, effective,||
0156|004|Z|or appropriate for you. This information is not individual||
0156|005|Z|medical advice and does not substitute for the advice of your||
0156|006|Z|health care professional. Always ask your health care||
0156|007|Z|professional for complete information about this product and your||
0156|008|Z|specific health needs.||
0156|009|B|||
0156|010|T|CHLORHEXIDINE GLUCONATE RINSE - ORAL||
0156|011|F|(khlor-HEX-i-deen GLOO-koe-nate)||
0156|012|B|||
0156|013|C|COMMON BRAND NAME(S): Peridex, Periogard||
0156|014|B|||
0156|015|U|USES:  This medication is used along with regular tooth||
0156|016|U|brushing/flossing to treat gingivitis, a gum disease that causes||
0156|017|U|red, swollen, and easily bleeding gums. Chlorhexidine belongs to||
0156|018|U|a class of drugs known as antimicrobials. It works by decreasing||
0156|019|U|the amount of bacteria in the mouth, helping to reduce swelling||
0156|020|U|and redness of the gums and bleeding when you brush.||
0156|021|B|||
0156|022|V|OTHER USES:  This section contains uses of this drug that are not||
0156|023|V|listed in the approved professional labeling for the drug but||
0156|024|V|that may be prescribed by your health care professional. Use this||
0156|025|V|drug for a condition that is listed in this section only if it||
0156|026|V|has been so prescribed by your health care professional.||
0156|027|V|   This drug may also be used by people with weakened immune||
0156|028|V|systems to decrease mouth sores (mucositis). It may also be used||
0156|029|V|to help hospitalized patients breathing through a ventilator not||
0156|030|V|get pneumonia.||
0156|031|B|||
0156|032|H|HOW TO USE:  Rinse your mouth with the solution after brushing||
0156|033|H|your teeth as directed by your doctor, usually twice daily (after||
0156|034|H|breakfast and at bedtime).||
0156|035|H|   Measure 1/2 ounce (15 milliliters) of the solution using the||
0156|036|H|supplied measuring cup. Swish the solution in your mouth for 30||
0156|037|H|seconds, and then spit it out.||
0156|038|H|   Do not swallow the solution or mix it with any other||
0156|039|H|substance. After using chlorhexidine, wait at least 30 minutes||
0156|040|H|before rinsing your mouth with water or mouthwash, brushing your||
0156|041|H|teeth, eating, or drinking.||
0156|042|H|   Dosage is based on your medical condition and response to||
0156|043|H|treatment.||
0156|044|H|   Use this medication regularly to get the most benefit from it.||
0156|045|H|To help you remember, use it at the same times each day. It may||
0156|046|H|take up to 6 weeks to see the full benefits of using this||
0156|047|H|medication.||
0156|048|H|   Tell your doctor if your condition lasts or gets worse.||
0156|049|B|||
0156|050|S|SIDE EFFECTS:  Tooth/tongue staining, increased tartar,||
0156|051|S|mouth/throat irritation, dry mouth, and change in taste of||
0156|052|S|food/drinks may occur. If any of these effects last or get worse,||
0156|053|S|tell your doctor or pharmacist promptly.||
0156|054|S|   To decrease staining of teeth and mouth surfaces, brush with||
0156|055|S|toothpaste 3 times daily, brushing more on the stained areas. Use||
0156|056|S|of a "tartar control" toothpaste and electric toothbrush may be||
0156|057|S|more effective. See your dentist at least every 6 months for||
0156|058|S|tooth cleaning/tartar removal. Staining from this medication that||
0156|059|S|may occur on dental work (such as crowns or veneers) usually can||
0156|060|S|only be removed by a dentist/hygienist. To decrease the effect on||
0156|061|S|how food tastes, eat first, followed by tooth brushing and then||
0156|062|S|chlorhexidine rinse.||
0156|063|S|   Remember that this medication has been prescribed because your||
0156|064|S|doctor or dentist has judged that the benefit to you is greater||
0156|065|S|than the risk of side effects. Many people using this medication||
0156|066|S|do not have serious side effects.||
0156|067|S|   A very serious allergic reaction to this drug is rare.||
0156|068|S|However, get medical help right away if you notice any symptoms||
0156|069|S|of a serious allergic reaction, including: mouth or skin rash,||
0156|070|S|itching/swelling (especially of the face/tongue/throat), severe||
0156|071|S|dizziness, trouble breathing.||
0156|072|S|   This is not a complete list of possible side effects. If you||
0156|073|S|notice other effects not listed above, contact your doctor or||
0156|074|S|pharmacist.||
0156|075|S|   In the US -||
0156|076|S|   Call your doctor for medical advice about side effects. You||
0156|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0156|078|S|www.fda.gov/medwatch.||
0156|079|S|   In Canada - Call your doctor for medical advice about side||
0156|080|S|effects. You may report side effects to Health Canada at||
0156|081|S|1-866-234-2345.||
0156|082|B|||
0156|083|P|PRECAUTIONS:  Before using chlorhexidine, tell your doctor or||
0156|084|P|pharmacist if you are allergic to it; or if you have any other||
0156|085|P|allergies. This product may contain inactive ingredients, which||
0156|086|P|can cause allergic reactions or other problems. Talk to your||
0156|087|P|pharmacist for more details.||
0156|088|P|   Before using this medication, tell your doctor or pharmacist||
0156|089|P|your medical history, especially of: dental crowns, veneers, or||
0156|090|P|fillings (especially if on the front teeth and if made of||
0156|091|P|porcelain).||
0156|092|P|   Tell your doctor if you are pregnant before using this||
0156|093|P|medication.||
0156|094|P|   It is unknown if this drug passes into breast milk. Consult||
0156|095|P|your doctor before breastfeeding.||
0156|096|B|||
0156|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0156|098|I|medications work or increase your risk for serious side effects.||
0156|099|I|This document does not contain all possible drug interactions.||
0156|100|I|Keep a list of all the products you use (including||
0156|101|I|prescription/nonprescription drugs and herbal products) and share||
0156|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
0156|103|I|the dosage of any medicines without your doctor's approval.||
0156|104|B|||
0156|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0156|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0156|107|O|poison control center right away. US residents can call||
0156|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0156|109|B|||
0156|110|N|NOTES:  Do not share this medication with others.||
0156|111|N|   Keep all medical/dental appointments so that your progress can||
0156|112|N|be followed. Consult your doctor/dentist for more details.||
0156|113|B|||
0156|114|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
0156|115|D|unless it is close to a mealtime or near the time for the next||
0156|116|D|dose. In those cases, skip the missed dose. Use your next dose at||
0156|117|D|the regular time. Do not double the dose to catch up.||
0156|118|B|||
0156|119|R|STORAGE:  Store at room temperature. Keep all medications away||
0156|120|R|from children and pets.||
0156|121|R|   Do not flush medications down the toilet or pour them into a||
0156|122|R|drain unless instructed to do so. Properly discard this product||
0156|123|R|when it is expired or no longer needed. Consult your pharmacist||
0156|124|R|or local waste disposal company.||
0156|125|B|||
0156|126|A|Information last revised May 2024.||
0156|127|A|Copyright(c) 2025 First Databank, Inc.||
0156|128|B|||
0157|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0157|002|Z|does NOT have all possible information about this product. This||
0157|003|Z|information does not assure that this product is safe, effective,||
0157|004|Z|or appropriate for you. This information is not individual||
0157|005|Z|medical advice and does not substitute for the advice of your||
0157|006|Z|health care professional. Always ask your health care||
0157|007|Z|professional for complete information about this product and your||
0157|008|Z|specific health needs.||
0157|009|B|||
0157|010|T|BCG VACCINE - INJECTION||
0157|011|B|||
0157|012|U|USES:  This vaccine is used to help prevent tuberculosis (TB). It||
0157|013|U|is recommended for people who have not been infected with the||
0157|014|U|disease but are at an increased risk of getting it. Those at||
0157|015|U|increased risk include certain health care personnel and children||
0157|016|U|who live with or spend much time with people with tuberculosis.||
0157|017|U|   This vaccine contains live bacteria that have been weakened.||
0157|018|U|It works by increasing the body's natural defense (immunity)||
0157|019|U|against the bacteria.||
0157|020|U|   Vaccines may not fully protect everyone who receives them.||
0157|021|U|   This form of the vaccine is not used to treat or prevent||
0157|022|U|bladder cancer.||
0157|023|B|||
0157|024|H|HOW TO USE:  This vaccine is given by injection into the skin by||
0157|025|H|a health care professional. It is given in the upper arm area.||
0157|026|H|After injection, the injection site should be loosely covered and||
0157|027|H|kept dry for 24 hours.||
0157|028|H|   This vaccine may be given at the same time as other vaccines.||
0157|029|B|||
0157|030|S|SIDE EFFECTS:  Pain at the injection site, muscle aches, fever,||
0157|031|S|or swollen lymph nodes may occur. If any of these effects last or||
0157|032|S|get worse, tell your health care professional promptly.||
0157|033|S|   Small red bumps may occur at the injection site. These bumps||
0157|034|S|will later crust and fall off 6 to 10 weeks later. A small, flat||
0157|035|S|scar may remain.||
0157|036|S|   Rarely, some people have symptoms such as fainting, dizziness,||
0157|037|S|vision changes, or ringing in the ears just after getting a||
0157|038|S|vaccine injection. Tell your health care professional right away||
0157|039|S|if you have any of these symptoms. Sitting or lying down may||
0157|040|S|help, since these symptoms usually don't last long.||
0157|041|S|   Remember that this vaccine has been prescribed because your||
0157|042|S|health care professional has judged that the benefit to you is||
0157|043|S|greater than the risk of side effects. Many people using this||
0157|044|S|vaccine do not have serious side effects.||
0157|045|S|   Tell your health care professional right away if you have any||
0157|046|S|serious side effects, including: sores/pus at the injection site,||
0157|047|S|bone pain, high fever (103 degrees F/39 degrees C or higher).||
0157|048|S|   A very serious allergic reaction to this vaccine is rare.||
0157|049|S|However, get medical help right away if you notice any symptoms||
0157|050|S|of a serious allergic reaction, including: rash, itching/swelling||
0157|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0157|052|S|breathing.||
0157|053|S|   This is not a complete list of possible side effects. If you||
0157|054|S|notice other effects not listed above, contact your health care||
0157|055|S|professional.||
0157|056|S|   Contact the health care professional for medical advice about||
0157|057|S|side effects. The following numbers do not provide medical||
0157|058|S|advice, but in the US you may report side effects to the Vaccine||
0157|059|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
0157|060|S|Canada, you may call the Vaccine Safety Section at Public Health||
0157|061|S|Agency of Canada at 1-866-844-0018.||
0157|062|B|||
0157|063|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
0157|064|P|care professional if you are allergic to it; or if you have any||
0157|065|P|other allergies. This product may contain inactive ingredients||
0157|066|P|(such as monosodium glutamate, polysorbate 80, latex), which can||
0157|067|P|cause allergic reactions or other problems. Talk to your health||
0157|068|P|care professional for more details.||
0157|069|P|   Before receiving this vaccine, tell your health care||
0157|070|P|professional your medical history, especially of: current||
0157|071|P|fever/illness, positive tuberculin skin test, immune system||
0157|072|P|disorders (such as due to HIV infection, certain cancers such as||
0157|073|P|leukemia/lymphoma, cancer or radiation treatment), burns or skin||
0157|074|P|disease over large area of skin, vaccination history (including||
0157|075|P|previous reactions to any vaccines).||
0157|076|P|   This vaccine is not recommended for use during pregnancy.||
0157|077|P|Consult your health care professional for more details.||
0157|078|P|   It is unknown if this vaccine passes into breast milk. Consult||
0157|079|P|your health care professional before breastfeeding.||
0157|080|B|||
0157|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0157|082|I|medications work or increase your risk for serious side effects.||
0157|083|I|This document does not contain all possible drug interactions.||
0157|084|I|Keep a list of all the products you use (including||
0157|085|I|prescription/nonprescription drugs and herbal products) and share||
0157|086|I|it with your health care professional. Do not start, stop, or||
0157|087|I|change the dosage of any medicines without your doctor's||
0157|088|I|approval.||
0157|089|I|   Some products that may interact with this vaccine are:||
0157|090|I|antibiotics (such as drugs to treat tuberculosis including||
0157|091|I|isoniazid, rifampin, ethambutol, pyrazinamide), drugs that weaken||
0157|092|I|the immune system (such as cyclosporine, tacrolimus, cancer||
0157|093|I|chemotherapy, corticosteroids such as prednisone), mefloquine.||
0157|094|I|   This vaccine may interfere with certain lab tests (such as TB||
0157|095|I|skin test), possibly causing false test results. Make sure lab||
0157|096|I|personnel and all your doctors know you recently received this||
0157|097|I|vaccine.||
0157|098|B|||
0157|099|O|OVERDOSE:  Not applicable.||
0157|100|B|||
0157|101|N|NOTES:  Keep all medical and lab appointments.||
0157|102|N|   Keep vaccine records for yourself and your children and||
0157|103|N|provide them to the health care professionals to prevent||
0157|104|N|unnecessary re-vaccinations.||
0157|105|B|||
0157|106|D|MISSED DOSE:  Not applicable.||
0157|107|B|||
0157|108|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
0157|109|R|light. Keep all medications away from children and pets.||
0157|110|R|   Do not flush medications down the toilet or pour them into a||
0157|111|R|drain unless instructed to do so. Properly discard this product||
0157|112|R|when it is expired or no longer needed. Consult your pharmacist||
0157|113|R|or local waste disposal company.||
0157|114|B|||
0157|115|A|Information last revised February 2025.||
0157|116|A|Copyright(c) 2025 First Databank, Inc.||
0157|117|B|||
0158|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0158|002|Z|does NOT have all possible information about this product. This||
0158|003|Z|information does not assure that this product is safe, effective,||
0158|004|Z|or appropriate for you. This information is not individual||
0158|005|Z|medical advice and does not substitute for the advice of your||
0158|006|Z|health care professional. Always ask your health care||
0158|007|Z|professional for complete information about this product and your||
0158|008|Z|specific health needs.||
0158|009|B|||
0158|010|T|FLUDROCORTISONE - ORAL||
0158|011|F|(FLOO-droe-KOR-ti-sone)||
0158|012|B|||
0158|013|C|COMMON BRAND NAME(S): Florinef||
0158|014|B|||
0158|015|U|USES:  Fludrocortisone is a man-made form of a natural substance||
0158|016|U|(glucocorticoid) made by the body. It is used along with other||
0158|017|U|medications (such as hydrocortisone) to treat low glucocorticoid||
0158|018|U|levels caused by disease of the adrenal gland (such as Addison's||
0158|019|U|disease, adrenocortical insufficiency, salt-losing adrenogenital||
0158|020|U|syndrome). Glucocorticoids are needed in many ways for the body||
0158|021|U|to function well. They are important for salt and water balance||
0158|022|U|and keeping blood pressure normal. They are also needed to break||
0158|023|U|down carbohydrates in your diet.||
0158|024|B|||
0158|025|V|OTHER USES:  This section contains uses of this drug that are not||
0158|026|V|listed in the approved professional labeling for the drug but||
0158|027|V|that may be prescribed by your health care professional. Use this||
0158|028|V|drug for a condition that is listed in this section only if it||
0158|029|V|has been so prescribed by your health care professional.||
0158|030|V|   This drug may also be used for a certain type of low blood||
0158|031|V|pressure (chronic postural hypotension).||
0158|032|B|||
0158|033|H|HOW TO USE:  Take this medication by mouth with or without food||
0158|034|H|as directed by your doctor, usually once daily. Your doctor will||
0158|035|H|adjust your dose to the one that is best for you. The dosage is||
0158|036|H|based on your medical condition and response to treatment.||
0158|037|H|   In order to get the most benefit from this medication, follow||
0158|038|H|the dosing schedule carefully, and take this medication exactly||
0158|039|H|as prescribed. To help you remember, take it at the same time||
0158|040|H|each day. If you are taking this medication on another schedule||
0158|041|H|besides every day (such as 3 days a week), mark your calendar||
0158|042|H|with a reminder. Do not increase or decrease your dose, take this||
0158|043|H|drug more often, or stop taking this medication without your||
0158|044|H|doctor's approval. Some conditions may become worse when the drug||
0158|045|H|is suddenly stopped. Your dose may need to be gradually||
0158|046|H|decreased.||
0158|047|H|   Tell your doctor if your condition lasts or gets worse.||
0158|048|B|||
0158|049|S|SIDE EFFECTS:  Stomach upset, headache, and menstrual changes||
0158|050|S|(such as delayed/irregular/absent periods) may occur. If any of||
0158|051|S|these effects last or get worse, contact your doctor or||
0158|052|S|pharmacist promptly.||
0158|053|S|   Remember that this medication has been prescribed because your||
0158|054|S|doctor has judged that the benefit to you is greater than the||
0158|055|S|risk of side effects. Many people using this medication do not||
0158|056|S|have serious side effects.||
0158|057|S|   Tell your doctor right away if you have any serious side||
0158|058|S|effects, including: change in skin appearance (such as color||
0158|059|S|changes, thinning, fatty areas), easy bleeding/bruising,||
0158|060|S|dizziness, slow wound healing, signs of infection (such as sore||
0158|061|S|throat that doesn't go away, fever, chills, skin sores),||
0158|062|S|bone/joint/muscle pain, puffy face, swelling of the hands/feet,||
0158|063|S|severe tiredness, increased thirst/urination, unusual weight||
0158|064|S|gain, muscle weakness, eye problems (such as pain, redness,||
0158|065|S|vision changes), severe/continuous headaches,||
0158|066|S|fast/pounding/irregular heartbeat, mental/mood changes (such as||
0158|067|S|agitation, depression, mood swings), seizure, symptoms of||
0158|068|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
0158|069|S|black/tarry stools, vomit that looks like coffee grounds),||
0158|070|S|red/purple spots on the skin.||
0158|071|S|   A very serious allergic reaction to this drug is rare.||
0158|072|S|However, get medical help right away if you notice any symptoms||
0158|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0158|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0158|075|S|breathing.||
0158|076|S|   This is not a complete list of possible side effects. If you||
0158|077|S|notice other effects not listed above, contact your doctor or||
0158|078|S|pharmacist.||
0158|079|S|   In the US -||
0158|080|S|   Call your doctor for medical advice about side effects. You||
0158|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0158|082|S|www.fda.gov/medwatch.||
0158|083|S|   In Canada - Call your doctor for medical advice about side||
0158|084|S|effects. You may report side effects to Health Canada at||
0158|085|S|1-866-234-2345.||
0158|086|B|||
0158|087|P|PRECAUTIONS:  Before taking fludrocortisone, tell your doctor or||
0158|088|P|pharmacist if you are allergic to it; or if you have any other||
0158|089|P|allergies. This product may contain inactive ingredients, which||
0158|090|P|can cause allergic reactions or other problems. Talk to your||
0158|091|P|pharmacist for more details.||
0158|092|P|   Before using this medication, tell your doctor or pharmacist||
0158|093|P|your medical history, especially of: bleeding problems, blood||
0158|094|P|clots, brittle bones (osteoporosis), diabetes, eye problems (such||
0158|095|P|as cataracts, glaucoma, infection of the eye), heart problems||
0158|096|P|(such as heart failure), high blood pressure, infections (such as||
0158|097|P|candidiasis, valley fever, herpes, tuberculosis), kidney disease,||
0158|098|P|liver disease (such as cirrhosis, hepatitis B), mental/mood||
0158|099|P|disorders (such as anxiety, depression, psychosis), low blood||
0158|100|P|minerals (such as calcium, potassium), stomach/intestinal||
0158|101|P|problems (such as diverticulitis, peptic ulcer disease,||
0158|102|P|ulcerative colitis), seizures, thyroid problems, a certain||
0158|103|P|adrenal gland tumor (pheochromocytoma).||
0158|104|P|   Fludrocortisone makes your body hold on to salt (sodium) and||
0158|105|P|get rid of other salts (such as calcium, potassium). Follow your||
0158|106|P|doctor's advice on how much salt, potassium, and calcium should||
0158|107|P|be in your diet.||
0158|108|P|   This medication may mask signs of infection. It can make you||
0158|109|P|more likely to get infections or may make current infections||
0158|110|P|worse. Stay away from anyone who has an infection that may easily||
0158|111|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0158|112|P|doctor if you have been exposed to an infection or for more||
0158|113|P|details.||
0158|114|P|   Do not have immunizations/vaccinations without the consent of||
0158|115|P|your doctor, and avoid contact with people who have recently||
0158|116|P|received oral polio vaccine or flu vaccine inhaled through the||
0158|117|P|nose.||
0158|118|P|   Using corticosteroid medications for a long time can make it||
0158|119|P|more difficult for your body to respond to physical stress.||
0158|120|P|Before having surgery or emergency treatment, or if you get a||
0158|121|P|serious illness/injury, tell your doctor or dentist that you are||
0158|122|P|using this medication or have used this medication within the||
0158|123|P|past 12 months. Tell your doctor right away if you develop||
0158|124|P|unusual/extreme tiredness or weight loss. If you will be using||
0158|125|P|this medication for a long time, carry a warning card or medical||
0158|126|P|ID bracelet that identifies your use of this medication.||
0158|127|P|   If you have a history of ulcers or take large doses of aspirin||
0158|128|P|or other arthritis medicine, limit alcoholic beverages while||
0158|129|P|taking this medication to lower the risk of stomach/intestinal||
0158|130|P|bleeding.||
0158|131|P|   If you have diabetes, this drug may make it harder to control||
0158|132|P|your blood sugar levels. Monitor your blood sugar levels||
0158|133|P|regularly and inform your doctor of the results. Your diabetic||
0158|134|P|medication or diet may need to be adjusted.||
0158|135|P|   This medication may slow down a child's growth if used for a||
0158|136|P|long time. Consult the doctor or pharmacist for more details. See||
0158|137|P|the doctor regularly so your child's height and growth can be||
0158|138|P|checked.||
0158|139|P|   Older adults may be more sensitive to the side effects of this||
0158|140|P|drug, especially water retention, bone loss/pain,||
0158|141|P|stomach/intestinal bleeding, and mental/mood changes (such as||
0158|142|P|confusion).||
0158|143|P|   During pregnancy, this medication should be used only when||
0158|144|P|clearly needed. Discuss the risks and benefits with your doctor.||
0158|145|P|Infants born to mothers who have been using this medication for||
0158|146|P|an extended time may have low levels of corticosteroid hormone.||
0158|147|P|Tell your doctor right away if you notice symptoms such as||
0158|148|P|nausea/vomiting that doesn't stop, severe diarrhea, or weakness||
0158|149|P|in your newborn.||
0158|150|P|   This medication passes into breast milk and may have||
0158|151|P|undesirable effects on a nursing infant. Consult your doctor||
0158|152|P|before breastfeeding.||
0158|153|B|||
0158|154|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0158|155|I|medications work or increase your risk for serious side effects.||
0158|156|I|This document does not contain all possible drug interactions.||
0158|157|I|Keep a list of all the products you use (including||
0158|158|I|prescription/nonprescription drugs and herbal products) and share||
0158|159|I|it with your doctor and pharmacist. Do not start, stop, or change||
0158|160|I|the dosage of any medicines without your doctor's approval.||
0158|161|I|   Some products that may interact with this drug are:||
0158|162|I|aldesleukin, desmopressin, digoxin, drugs that can cause||
0158|163|I|bleeding/bruising (including antiplatelet drugs such as||
0158|164|I|clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs||
0158|165|I|such as aspirin/celecoxib/ibuprofen), hormones (such as||
0158|166|I|androgens, birth control pills, estrogens), immunosuppressants||
0158|167|I|(such as cyclosporine), mifepristone.||
0158|168|I|   If your doctor has told you to take low-dose aspirin to||
0158|169|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0158|170|I|you should keep taking the aspirin unless your doctor tells you||
0158|171|I|not to. Ask your doctor or pharmacist for more details.||
0158|172|I|   This medication may interfere with certain lab tests, possibly||
0158|173|I|causing false test results. Make sure lab personnel and all your||
0158|174|I|doctors know you use this drug.||
0158|175|B|||
0158|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0158|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0158|178|O|poison control center right away. US residents can call||
0158|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0158|180|O|Symptoms of overdose may include high blood pressure, water||
0158|181|O|retention, extreme weight gain, and muscle weakness.||
0158|182|B|||
0158|183|N|NOTES:  Do not share this medication with others.||
0158|184|N|   Lab and/or medical tests (such as blood pressure, eye exams,||
0158|185|N|sodium/potassium levels) should be done while you are taking this||
0158|186|N|medication. Keep all medical and lab appointments. Consult your||
0158|187|N|doctor for more details.||
0158|188|B|||
0158|189|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0158|190|D|remember. If it is near the time of the next dose, skip the||
0158|191|D|missed dose. Take your next dose at the regular time. Do not||
0158|192|D|double the dose to catch up.||
0158|193|B|||
0158|194|R|STORAGE:  Different brands of this product have different storage||
0158|195|R|needs. Check the product package for instructions on how to store||
0158|196|R|your brand or ask the pharmacist. Do not store in the bathroom.||
0158|197|R|Keep all medications away from children and pets.||
0158|198|R|   Do not flush medications down the toilet or pour them into a||
0158|199|R|drain unless instructed to do so. Properly discard this product||
0158|200|R|when it is expired or no longer needed. Consult your pharmacist||
0158|201|R|or local waste disposal company.||
0158|202|B|||
0158|203|M|MEDICAL ALERT:  Your condition can cause complications in a||
0158|204|M|medical emergency. For information about enrolling in MedicAlert,||
0158|205|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0158|206|B|||
0158|207|A|Information last revised October 2025.||
0158|208|A|Copyright(c) 2025 First Databank, Inc.||
0158|209|B|||
0159|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0159|002|Z|does NOT have all possible information about this product. This||
0159|003|Z|information does not assure that this product is safe, effective,||
0159|004|Z|or appropriate for you. This information is not individual||
0159|005|Z|medical advice and does not substitute for the advice of your||
0159|006|Z|health care professional. Always ask your health care||
0159|007|Z|professional for complete information about this product and your||
0159|008|Z|specific health needs.||
0159|009|B|||
0159|010|T|EPOETIN ALFA - INJECTION||
0159|011|F|(e-POE-tin AL-fa)||
0159|012|B|||
0159|013|C|COMMON BRAND NAME(S): Epogen, Procrit, Retacrit||
0159|014|B|||
0159|015|W|WARNING:  Discuss the risks and benefits of epoetin alfa with||
0159|016|W|your doctor, as this medication may rarely cause very serious||
0159|017|W|(possibly fatal) side effects, including blood clots, heart||
0159|018|W|attack, stroke, or heart failure. It is very important to keep||
0159|019|W|all lab appointments since your doctor will need to carefully||
0159|020|W|check your red blood cell count and hemoglobin level. The lowest||
0159|021|W|effective dose of this medication should be used.||
0159|022|W|   When used to treat anemia related to cancer, this medication||
0159|023|W|may also increase the risk of death and/or cause your tumor to||
0159|024|W|grow faster. This medication should be stopped after completing a||
0159|025|W|treatment course of chemotherapy as directed by your doctor.||
0159|026|B|||
0159|027|U|USES:  This medication is used to treat anemia (low red blood||
0159|028|U|cell count) in people with long-term serious kidney disease||
0159|029|U|(chronic kidney failure), people receiving zidovudine to treat||
0159|030|U|HIV, and people receiving chemotherapy for some types of cancer||
0159|031|U|(cancer that does not involve the bone marrow or blood cells). It||
0159|032|U|may also be used in anemic patients to reduce the need for blood||
0159|033|U|transfusions before certain planned surgeries that have a high||
0159|034|U|risk of blood loss (usually given with an anticoagulant/"blood||
0159|035|U|thinner" medication such as warfarin to lower the risk of serious||
0159|036|U|blood clots). Epoetin alfa works by signaling the bone marrow to||
0159|037|U|make more red blood cells. This medication is very similar to the||
0159|038|U|natural substance in your body (erythropoietin) that prevents||
0159|039|U|anemia.||
0159|040|U|   This monograph is about the following epoetin alfa products:||
0159|041|U|epoetin alfa and epoetin alfa-epbx.||
0159|042|B|||
0159|043|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0159|044|H|Instructions for Use provided by your pharmacist before you start||
0159|045|H|using this medication and each time you get a refill. If you have||
0159|046|H|any questions, ask your doctor or pharmacist.||
0159|047|H|   This medication is given as an injection under the skin or||
0159|048|H|into a vein as directed by your doctor, usually 1 to 3 times a||
0159|049|H|week. Patients getting this medication before surgery may have a||
0159|050|H|special dosing schedule. Hemodialysis patients should receive||
0159|051|H|this medication by injection into a vein. If injecting this||
0159|052|H|medication under the skin, the injection is given in the upper||
0159|053|H|arms, abdomen, front of the middle thighs, or upper outer area of||
0159|054|H|the buttocks. The dosage is based on your medical condition,||
0159|055|H|weight, labs, and response to treatment.||
0159|056|H|   If you are using this medication at home, learn all||
0159|057|H|preparation and usage instructions from your health care||
0159|058|H|professional. Do not shake this medication. Before using, check||
0159|059|H|this product for particles or discoloration. If either is||
0159|060|H|present, do not use the liquid. If you are injecting this||
0159|061|H|medication under the skin, before each dose, clean the skin you||
0159|062|H|are going to inject into (the injection site) with rubbing||
0159|063|H|alcohol. Change the injection site each time to lessen injury||
0159|064|H|under the skin. Do not inject into skin that is tender, red,||
0159|065|H|bruised, hard, or has scars or stretch marks. To lessen bruising,||
0159|066|H|do not rub the injection site after a shot. Learn how to store||
0159|067|H|and discard medical supplies safely.||
0159|068|H|   Use this medication regularly to get the most benefit from it.||
0159|069|H|To help you remember, use it on the same day(s) of the week as||
0159|070|H|directed.||
0159|071|H|   Do not increase your dose or use this drug more often or for||
0159|072|H|longer than prescribed. Your condition will not improve any||
0159|073|H|faster, and your risk of side effects will increase.||
0159|074|H|   It may take 2 to 6 weeks before your red blood cell count||
0159|075|H|increases. Tell your doctor if your symptoms do not get better or||
0159|076|H|if they get worse.||
0159|077|B|||
0159|078|S|SIDE EFFECTS:  Headache, body aches, cough, or injection site||
0159|079|S|irritation/pain may occur. If any of these effects last or get||
0159|080|S|worse, tell your doctor or pharmacist promptly.||
0159|081|S|   Remember that this medication has been prescribed because your||
0159|082|S|doctor has judged that the benefit to you is greater than the||
0159|083|S|risk of side effects. Many people using this medication do not||
0159|084|S|have serious side effects.||
0159|085|S|   Epoetin alfa may sometimes cause or worsen high blood||
0159|086|S|pressure, especially in patients with long-term kidney failure.||
0159|087|S|This effect may be caused by the number of red blood cells||
0159|088|S|increasing too quickly, usually within the first 3 months of||
0159|089|S|starting treatment. If you have high blood pressure, it should be||
0159|090|S|well controlled before beginning treatment with this medication.||
0159|091|S|Your blood pressure should be checked often. Ask your doctor if||
0159|092|S|you should learn how to check your own blood pressure. If high||
0159|093|S|blood pressure develops or worsens, follow your doctor's||
0159|094|S|instructions about diet changes and starting or adjusting your||
0159|095|S|high blood pressure medication. Lowering high blood pressure||
0159|096|S|helps prevent strokes, heart attacks, and further kidney||
0159|097|S|problems. Keep all lab appointments to have your red blood cell||
0159|098|S|count/hemoglobin level tested regularly to reduce the chance of||
0159|099|S|this side effect.||
0159|100|S|   Rarely, this medication may suddenly stop working well after a||
0159|101|S|period of time because your body may make antibodies to it. A||
0159|102|S|very serious anemia can result. Tell your doctor right away if||
0159|103|S|symptoms of anemia return (such as increased tiredness, low||
0159|104|S|energy, pale skin color, shortness of breath).||
0159|105|S|   Tell your doctor right away if you have any serious side||
0159|106|S|effects, including: symptoms of heart failure (such as shortness||
0159|107|S|of breath, swelling ankles/feet, unusual tiredness,||
0159|108|S|unusual/sudden weight gain).||
0159|109|S|   Get medical help right away if you have any very serious side||
0159|110|S|effects, including: seizures.||
0159|111|S|   This medication may rarely cause serious (sometimes fatal)||
0159|112|S|problems from blood clots (such as heart attack, stroke, blood||
0159|113|S|clots in the lungs or legs). You may be at increased risk for||
0159|114|S|blood clots if you are severely dehydrated, or have a history of||
0159|115|S|blood clots, heart/blood vessel disease, heart failure, stroke,||
0159|116|S|pregnant, or if you are immobile (such as on very long plane||
0159|117|S|flights or being bedridden). If you use estrogen-containing||
0159|118|S|products, these may also increase your risk. Before using this||
0159|119|S|medication, if you have any of these conditions report them to||
0159|120|S|your doctor or pharmacist. Get medical help right away if any of||
0159|121|S|these side effects occur: shortness of breath/rapid breathing,||
0159|122|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
0159|123|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0159|124|S|sudden/severe headaches, trouble speaking, weakness on one side||
0159|125|S|of the body, sudden vision changes, blood clots in your||
0159|126|S|hemodialysis vascular access site.||
0159|127|S|   A very serious allergic reaction to this drug is rare.||
0159|128|S|However, get medical help right away if you notice any symptoms||
0159|129|S|of a serious allergic reaction, including: rash, itching/swelling||
0159|130|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0159|131|S|breathing.||
0159|132|S|   This is not a complete list of possible side effects. If you||
0159|133|S|notice other effects not listed above, contact your doctor or||
0159|134|S|pharmacist.||
0159|135|S|   In the US -||
0159|136|S|   Call your doctor for medical advice about side effects. You||
0159|137|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0159|138|S|www.fda.gov/medwatch.||
0159|139|S|   In Canada - Call your doctor for medical advice about side||
0159|140|S|effects. You may report side effects to Health Canada at||
0159|141|S|1-866-234-2345.||
0159|142|B|||
0159|143|P|PRECAUTIONS:  Before using epoetin alfa, tell your doctor or||
0159|144|P|pharmacist if you are allergic to it; or to any epoetin alfa||
0159|145|P|products; or to other drugs that cause more red blood cells to be||
0159|146|P|made (such as darbepoetin alfa); or if you have any other||
0159|147|P|allergies. This product may contain inactive ingredients (such as||
0159|148|P|benzyl alcohol), which can cause allergic reactions or other||
0159|149|P|problems. Talk to your pharmacist for more details.||
0159|150|P|   Before using this medication, tell your doctor or pharmacist||
0159|151|P|your medical history, especially of: high blood pressure, heart||
0159|152|P|disease (such as heart failure, past heart attack/stroke),||
0159|153|P|seizure disorder, severe anemia caused by antibodies to past||
0159|154|P|erythropoietin-type treatment (pure red cell aplasia).||
0159|155|P|   Some forms of this medication are made from human blood. Even||
0159|156|P|though the blood is carefully tested, and this medication goes||
0159|157|P|through a special manufacturing process, there is an extremely||
0159|158|P|small chance that you may get infections from the medication (for||
0159|159|P|example, viruses such as hepatitis). Consult your doctor or||
0159|160|P|pharmacist for more information.||
0159|161|P|   This medication may contain phenylalanine. If you have||
0159|162|P|phenylketonuria (PKU) or any other condition that requires you to||
0159|163|P|limit/avoid phenylalanine (or aspartame) in your diet, ask your||
0159|164|P|doctor or pharmacist about using this medication safely.||
0159|165|P|   Before having surgery, tell your doctor or dentist about all||
0159|166|P|the products you use (including prescription drugs,||
0159|167|P|nonprescription drugs, and herbal products).||
0159|168|P|   During pregnancy, this medication should be used only when||
0159|169|P|clearly needed. Discuss the risks and benefits with your doctor.||
0159|170|P|   It is unknown if this medication passes into breast milk.||
0159|171|P|Consult your doctor before breastfeeding.||
0159|172|B|||
0159|173|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0159|174|I|medications work or increase your risk for serious side effects.||
0159|175|I|This document does not contain all possible drug interactions.||
0159|176|I|Keep a list of all the products you use (including||
0159|177|I|prescription/nonprescription drugs and herbal products) and share||
0159|178|I|it with your doctor and pharmacist. Do not start, stop, or change||
0159|179|I|the dosage of any medicines without your doctor's approval.||
0159|180|B|||
0159|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0159|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0159|183|O|poison control center right away. US residents can call||
0159|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0159|185|B|||
0159|186|N|NOTES:  Do not share this medication with others.||
0159|187|N|   Lab and/or medical tests (such as blood pressure, complete||
0159|188|N|blood count that includes hemoglobin level) should be done while||
0159|189|N|you are using this medication. Keep all medical and lab||
0159|190|N|appointments. Consult your doctor for more details.||
0159|191|N|   Blood tests for your iron levels will also be done and you may||
0159|192|N|be prescribed iron supplements to take. Your doctor may recommend||
0159|193|N|that you eat a well-balanced diet rich in iron (such as raisins,||
0159|194|N|figs, meat, eggs, vegetables, iron-fortified cereals). Follow||
0159|195|N|your doctor's instructions and dietary recommendations.||
0159|196|B|||
0159|197|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
0159|198|D|right away for a new dosing schedule. Do not double the dose to||
0159|199|D|catch up.||
0159|200|B|||
0159|201|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
0159|202|R|medication in the original carton to protect from light. For the||
0159|203|R|single-use vials, discard any unused medication right away. For||
0159|204|R|the multi-use vials, store opened vials in the refrigerator and||
0159|205|R|discard any unused medication after 3 weeks. Keep all medications||
0159|206|R|away from children and pets.||
0159|207|R|   Do not flush medications down the toilet or pour them into a||
0159|208|R|drain unless instructed to do so. Properly discard this product||
0159|209|R|when it is expired or no longer needed. Consult your pharmacist||
0159|210|R|or local waste disposal company.||
0159|211|B|||
0159|212|A|Information last revised October 2024.||
0159|213|A|Copyright(c) 2025 First Databank, Inc.||
0159|214|B|||
0162|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0162|002|Z|does NOT have all possible information about this product. This||
0162|003|Z|information does not assure that this product is safe, effective,||
0162|004|Z|or appropriate for you. This information is not individual||
0162|005|Z|medical advice and does not substitute for the advice of your||
0162|006|Z|health care professional. Always ask your health care||
0162|007|Z|professional for complete information about this product and your||
0162|008|Z|specific health needs.||
0162|009|B|||
0162|010|T|GOSERELIN - IMPLANT||
0162|011|F|(GOE-se-REL-in)||
0162|012|B|||
0162|013|C|COMMON BRAND NAME(S): Zoladex||
0162|014|B|||
0162|015|U|USES:  Goserelin is used to treat certain types of cancer||
0162|016|U|(prostate and breast). It is also used to thin the lining of the||
0162|017|U|uterus (endometrium) in preparation for a procedure to treat||
0162|018|U|abnormal uterine bleeding. Goserelin is also used to treat a||
0162|019|U|condition in which the tissue that normally lines the inside of||
0162|020|U|the uterus also grows outside the uterus (endometriosis). Talk to||
0162|021|U|your doctor about the risks and benefits of treatment.||
0162|022|U|   Goserelin is similar to a natural hormone made by the body||
0162|023|U|(luteinizing hormone releasing hormone-LHRH). It works by||
0162|024|U|decreasing testosterone hormones and estrogen hormones. This||
0162|025|U|effect helps to slow or stop the growth of certain cancer cells||
0162|026|U|and uterine tissue that need these hormones to grow and spread.||
0162|027|B|||
0162|028|V|OTHER USES:  This section contains uses of this drug that are not||
0162|029|V|listed in the approved professional labeling for the drug but||
0162|030|V|that may be prescribed by your health care professional. Use this||
0162|031|V|drug for a condition that is listed in this section only if it||
0162|032|V|has been so prescribed by your health care professional.||
0162|033|V|   This medication may also be used to stop early puberty in||
0162|034|V|children.||
0162|035|B|||
0162|036|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0162|037|H|from your pharmacist before you start using goserelin and each||
0162|038|H|time you get a refill. If you have any questions, ask your doctor||
0162|039|H|or pharmacist.||
0162|040|H|   This medication is an implant that slowly releases hormone||
0162|041|H|into your body. It is placed by a health care professional by||
0162|042|H|injection under the skin of the lower abdomen below the navel.||
0162|043|H|The implant itself will be completely absorbed into the body over||
0162|044|H|weeks or months.||
0162|045|H|   Receive this medication as directed by your doctor. The||
0162|046|H|3.6-milligram syringe is usually injected every 4 weeks. The||
0162|047|H|10.8-milligram syringe is usually injected every 12 to 13 weeks.||
0162|048|H|Follow the dosing schedule carefully to get the most benefit from||
0162|049|H|it. To help you remember, mark your calendar with a reminder. Do||
0162|050|H|not stop this medication without your doctor's approval.||
0162|051|H|   The dosage is based on your medical condition and response to||
0162|052|H|treatment.||
0162|053|H|   During the first few weeks of treatment, your hormone levels||
0162|054|H|will actually increase before they decrease. This is a normal||
0162|055|H|response by your body to this drug. This may cause new or||
0162|056|H|worsening symptoms (such as increased pain, increased difficulty||
0162|057|H|urinating in men) for the first few weeks. Tell your doctor right||
0162|058|H|away about these symptoms. See also Side Effects section.||
0162|059|H|   In women, menstrual periods should stop when this medication||
0162|060|H|is used regularly. Tell your doctor promptly if regular periods||
0162|061|H|continue after 2 months of treatment with goserelin.||
0162|062|H|   Usually, this medication will not need to be removed because||
0162|063|H|the implant will be slowly and completely absorbed by your body.||
0162|064|H|However, in the unlikely event that you have serious side effects||
0162|065|H|or other problems, your doctor may remove this medication.||
0162|066|H|   Tell your doctor if your condition gets worse.||
0162|067|B|||
0162|068|S|SIDE EFFECTS:  Hot flashes (flushing), dizziness, headache,||
0162|069|S|increased sweating, decreased sexual interest/ability, trouble||
0162|070|S|sleeping, nausea, change in breast size, vaginal dryness, or hair||
0162|071|S|loss may occur. Pain, bruising, bleeding, redness, or swelling at||
0162|072|S|the injection site may also occur. If any of these effects last||
0162|073|S|or get worse, tell your doctor or pharmacist promptly.||
0162|074|S|   Remember that this medication has been prescribed because your||
0162|075|S|doctor has judged that the benefit to you is greater than the||
0162|076|S|risk of side effects. Many people using this medication do not||
0162|077|S|have serious side effects.||
0162|078|S|   Tell your doctor right away if you have any serious side||
0162|079|S|effects, including: vaginal burning/pain, pain during sex (in||
0162|080|S|women), breast pain/tenderness, new/worsening bone pain, new||
0162|081|S|broken bone, burning feeling in feet/toes, swelling of the||
0162|082|S|ankles/feet, unusual tiredness, signs of kidney problems (such as||
0162|083|S|change in the amount of urine), mental/mood changes (such as||
0162|084|S|depression, mood swings, hallucinations), signs of liver disease||
0162|085|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
0162|086|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0162|087|S|   This medication may rarely make your blood sugar rise, which||
0162|088|S|can cause or worsen diabetes. Tell your doctor right away if you||
0162|089|S|have symptoms of high blood sugar such as increased||
0162|090|S|thirst/urination. If you already have diabetes, check your blood||
0162|091|S|sugar regularly as directed and share the results with your||
0162|092|S|doctor. Your doctor may need to adjust your diabetes medication,||
0162|093|S|exercise program, or diet.||
0162|094|S|   Get medical help right away if you have any very serious side||
0162|095|S|effects, including: symptoms of a heart attack (such as||
0162|096|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
0162|097|S|signs of a stroke (such as weakness on one side of the body,||
0162|098|S|trouble speaking, sudden vision changes, confusion),||
0162|099|S|fast/irregular heartbeat, severe dizziness, fainting.||
0162|100|S|   In men using this medication for prostate cancer, a rare but||
0162|101|S|very serious urinary blockage problem or spinal cord problem||
0162|102|S|(compression) can occur, especially during the first month of||
0162|103|S|treatment. Tell your doctor right away if you have any of the||
0162|104|S|following serious side effects: severe back pain,||
0162|105|S|numbness/tingling/weakness of the arms/legs, inability to move,||
0162|106|S|painful/difficult urination, blood in the urine.||
0162|107|S|   A very serious allergic reaction to this drug is rare.||
0162|108|S|However, get medical help right away if you notice any symptoms||
0162|109|S|of a serious allergic reaction, including: fever, swollen lymph||
0162|110|S|nodes, rash, itching/swelling (especially of the||
0162|111|S|face/tongue/throat), severe dizziness, trouble breathing.||
0162|112|S|   This is not a complete list of possible side effects. If you||
0162|113|S|notice other effects not listed above, contact your doctor or||
0162|114|S|pharmacist.||
0162|115|S|   In the US -||
0162|116|S|   Call your doctor for medical advice about side effects. You||
0162|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0162|118|S|www.fda.gov/medwatch.||
0162|119|S|   In Canada - Call your doctor for medical advice about side||
0162|120|S|effects. You may report side effects to Health Canada at||
0162|121|S|1-866-234-2345.||
0162|122|B|||
0162|123|P|PRECAUTIONS:  Before using goserelin, tell your doctor or||
0162|124|P|pharmacist if you are allergic to it; or to LHRH or LHRH-like||
0162|125|P|hormones (such as triptorelin); or if you have any other||
0162|126|P|allergies. This product may contain inactive ingredients, which||
0162|127|P|can cause allergic reactions or other problems. Talk to your||
0162|128|P|pharmacist for more details.||
0162|129|P|   Before using this medication, tell your doctor or pharmacist||
0162|130|P|your medical history, especially of: unexplained abnormal vaginal||
0162|131|P|bleeding, diabetes, long-term alcohol use, smoking, personal or||
0162|132|P|family history of bone loss (osteoporosis), heart disease (such||
0162|133|P|as heart attack), high cholesterol/triglyceride levels, stroke,||
0162|134|P|urinary blockage problem (in men), spinal cord problem (in men),||
0162|135|P|mental/mood problems (such as depression).||
0162|136|P|   If you have diabetes, this drug may make it harder to control||
0162|137|P|your blood sugar. Check your blood sugar regularly as directed||
0162|138|P|and share the results with your doctor. Tell your doctor right||
0162|139|P|away if you have symptoms of high blood sugar (see Side Effects||
0162|140|P|section). Your doctor may need to adjust your diabetes||
0162|141|P|medication, exercise program, or diet.||
0162|142|P|   Goserelin may cause a condition that affects the heart rhythm||
0162|143|P|(QT prolongation). QT prolongation can rarely cause serious||
0162|144|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0162|145|P|as severe dizziness, fainting) that need medical attention right||
0162|146|P|away.||
0162|147|P|   The risk of QT prolongation may be increased if you have||
0162|148|P|certain medical conditions or are taking other drugs that may||
0162|149|P|cause QT prolongation. Before using goserelin, tell your doctor||
0162|150|P|or pharmacist of all the drugs you take and if you have any of||
0162|151|P|the following conditions: certain heart problems (heart failure,||
0162|152|P|slow heartbeat, QT prolongation in the EKG), family history of||
0162|153|P|certain heart problems (QT prolongation in the EKG, sudden||
0162|154|P|cardiac death).||
0162|155|P|   Low levels of potassium or magnesium in the blood may also||
0162|156|P|increase your risk of QT prolongation. This risk may increase if||
0162|157|P|you use certain drugs (such as diuretics/"water pills") or if you||
0162|158|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0162|159|P|Talk to your doctor about using goserelin safely.||
0162|160|P|   Older adults may be more sensitive to the side effects of this||
0162|161|P|drug, especially QT prolongation (see above).||
0162|162|P|   Tell your doctor if you are pregnant or plan to become||
0162|163|P|pregnant. You should not become pregnant while using goserelin.||
0162|164|P|Goserelin may harm an unborn baby. Ask about reliable||
0162|165|P|non-hormonal forms of birth control (such as condoms, diaphragm||
0162|166|P|with spermicide) while using this medication and for 12 weeks||
0162|167|P|after the last dose or until the return of your period. If you||
0162|168|P|become pregnant, talk to your doctor right away about the risks||
0162|169|P|and benefits of this medication.||
0162|170|P|   It is unknown if this medication passes into breast milk.||
0162|171|P|Because of the possible risk to the infant, breastfeeding is not||
0162|172|P|recommended while using this medication. Consult your doctor||
0162|173|P|before breastfeeding.||
0162|174|B|||
0162|175|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0162|176|I|medications work or increase your risk for serious side effects.||
0162|177|I|This document does not contain all possible drug interactions.||
0162|178|I|Keep a list of all the products you use (including||
0162|179|I|prescription/nonprescription drugs and herbal products) and share||
0162|180|I|it with your doctor and pharmacist. Do not start, stop, or change||
0162|181|I|the dosage of any medicines without your doctor's approval.||
0162|182|B|||
0162|183|O|OVERDOSE:  This implant may be harmful if swallowed. If someone||
0162|184|O|has swallowed it and has serious symptoms such as passing out or||
0162|185|O|trouble breathing, call 911. Otherwise, call a poison control||
0162|186|O|center right away. US residents can call 1-800-222-1222. Canada||
0162|187|O|residents can call 1-844-764-7669.||
0162|188|B|||
0162|189|N|NOTES:  Lab and/or medical tests (such as blood sugar, hormone||
0162|190|N|levels, cholesterol/triglyceride levels) should be done while you||
0162|191|N|are using this medication. Keep all medical and lab appointments.||
0162|192|N|Consult your doctor for more details.||
0162|193|B|||
0162|194|D|MISSED DOSE:  It is important to get each dose of this medication||
0162|195|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0162|196|D|right away for a new dosing schedule.||
0162|197|D|   Sudden/unusual vaginal bleeding (breakthrough bleeding) may||
0162|198|D|occur if a dose is missed.||
0162|199|B|||
0162|200|R|STORAGE:  Different brands of this medication have different||
0162|201|R|storage needs. Check the product package for instructions on how||
0162|202|R|to store your brand, or ask your pharmacist. Keep all medications||
0162|203|R|away from children and pets.||
0162|204|R|   Do not flush medications down the toilet or pour them into a||
0162|205|R|drain unless instructed to do so. Properly discard this product||
0162|206|R|when it is expired or no longer needed. Consult your pharmacist||
0162|207|R|or local waste disposal company.||
0162|208|B|||
0162|209|A|Information last revised September 2025.||
0162|210|A|Copyright(c) 2025 First Databank, Inc.||
0162|211|B|||
0164|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0164|002|Z|does NOT have all possible information about this product. This||
0164|003|Z|information does not assure that this product is safe, effective,||
0164|004|Z|or appropriate for you. This information is not individual||
0164|005|Z|medical advice and does not substitute for the advice of your||
0164|006|Z|health care professional. Always ask your health care||
0164|007|Z|professional for complete information about this product and your||
0164|008|Z|specific health needs.||
0164|009|B|||
0164|010|T|EMOLLIENTS - TOPICAL||
0164|011|B|||
0164|012|U|USES:  This medication is used as a moisturizer to treat or||
0164|013|U|prevent dry, rough, scaly, itchy skin and minor skin irritations||
0164|014|U|(such as diaper rash, skin burns from radiation therapy).||
0164|015|U|Emollients are substances that soften and moisturize the skin and||
0164|016|U|decrease itching and flaking. Some products (such as zinc oxide,||
0164|017|U|white petrolatum) are used mostly to protect the skin against||
0164|018|U|irritation (such as from wetness).||
0164|019|U|   Dry skin is caused by a loss of water in the upper layer of||
0164|020|U|the skin. Emollients/moisturizers work by forming an oily layer||
0164|021|U|on the top of the skin that traps water in the skin. Petrolatum,||
0164|022|U|lanolin, mineral oil and dimethicone are common emollients.||
0164|023|U|Humectants, including glycerin, lecithin, and propylene glycol,||
0164|024|U|draw water into the outer layer of skin. Many products also have||
0164|025|U|ingredients that soften the horny substance (keratin) that holds||
0164|026|U|the top layer of skin cells together (including urea, alpha||
0164|027|U|hydroxy acids such as lactic/citric/glycolic acid, and||
0164|028|U|allantoin). This helps the dead skin cells fall off, helps the||
0164|029|U|skin keep in more water, and leaves the skin feeling smoother and||
0164|030|U|softer.||
0164|031|B|||
0164|032|H|HOW TO USE:  Use this product as directed. Some products require||
0164|033|H|priming before use. Follow all directions on the product package.||
0164|034|H|If you have any questions, ask your doctor or pharmacist.||
0164|035|H|   Some products need to be shaken before use. Check the label to||
0164|036|H|see if you should shake the bottle well before using. Apply to||
0164|037|H|the affected areas of the skin as needed or as directed on the||
0164|038|H|label or by your doctor. How often you apply the medication will||
0164|039|H|depend on the product and your skin condition. To treat dry||
0164|040|H|hands, you may need to use the product every time you wash your||
0164|041|H|hands, applying it throughout the day.||
0164|042|H|   If you are using this product to help treat diaper rash, clean||
0164|043|H|the diaper area well before use and allow the area to dry before||
0164|044|H|applying the product.||
0164|045|H|   If you are using this product to help treat radiation skin||
0164|046|H|burns, check with radiation personnel to see if your brand can be||
0164|047|H|applied before radiation treatment.||
0164|048|H|   Follow all the directions on the label for proper use. Apply||
0164|049|H|to the skin only. Avoid sensitive areas such as your eyes, inside||
0164|050|H|your mouth/nose, and the vaginal/groin area, unless the label or||
0164|051|H|your doctor directs you otherwise. Check the label for directions||
0164|052|H|about any areas or types of skin where you should not apply the||
0164|053|H|product (such as on the face, any areas of||
0164|054|H|broken/chapped/cut/irritated/scraped skin, or on a recently||
0164|055|H|shaved area of the skin). Consult your doctor or pharmacist for||
0164|056|H|more details.||
0164|057|H|   Use this medication regularly to get the most benefit from it.||
0164|058|H|Most moisturizers need water to work well. Apply the product||
0164|059|H|after bathing/showering while the skin is still damp. For very||
0164|060|H|dry skin, your doctor may instruct you to soak the area before||
0164|061|H|using the product. Long, hot, or frequent bathing/washing can||
0164|062|H|worsen dry skin.||
0164|063|H|   If your condition lasts or gets worse, or if you think you may||
0164|064|H|have a serious medical problem, get medical help right away.||
0164|065|B|||
0164|066|S|SIDE EFFECTS:  Most emollients can be used safely and effectively||
0164|067|S|with no side effects. However, burning, stinging, redness, or||
0164|068|S|irritation may occur. If any of these effects last or get worse,||
0164|069|S|tell your doctor or pharmacist promptly.||
0164|070|S|   If your doctor has prescribed this medication, remember that||
0164|071|S|your doctor has judged that the benefit to you is greater than||
0164|072|S|the risk of side effects. Many people using this medication do||
0164|073|S|not have serious side effects.||
0164|074|S|   Tell your doctor right away if you have any serious side||
0164|075|S|effects, including: unusual changes in the skin (such as turning||
0164|076|S|white/soft/soggy from too much wetness), signs of skin infection.||
0164|077|S|   A very serious allergic reaction to this drug is rare.||
0164|078|S|However, get medical help right away if you notice any symptoms||
0164|079|S|of a serious allergic reaction, including: rash, itching/swelling||
0164|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0164|081|S|breathing.||
0164|082|S|   This is not a complete list of possible side effects. If you||
0164|083|S|notice other effects not listed above, contact your doctor or||
0164|084|S|pharmacist.||
0164|085|S|   In the US -||
0164|086|S|   Call your doctor for medical advice about side effects. You||
0164|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0164|088|S|www.fda.gov/medwatch.||
0164|089|S|   In Canada - Call your doctor for medical advice about side||
0164|090|S|effects. You may report side effects to Health Canada at||
0164|091|S|1-866-234-2345.||
0164|092|B|||
0164|093|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0164|094|P|pharmacist if you are allergic to any of the ingredients in the||
0164|095|P|product; or if you have any other allergies. This product may||
0164|096|P|contain inactive ingredients, which can cause allergic reactions||
0164|097|P|or other problems. Talk to your pharmacist for more details.||
0164|098|P|   If you have any of the following health problems, consult your||
0164|099|P|doctor or pharmacist before using this product: skin||
0164|100|P|cuts/infections/sores.||
0164|101|P|   Some ingredients (such as preservatives, fragrance) may make||
0164|102|P|you more sensitive to the sun. Check the label for any warnings||
0164|103|P|or ask your doctor or pharmacist if you need to take any special||
0164|104|P|precautions when in the sun. Your doctor/pharmacist may suggest||
0164|105|P|that you limit your time in the sun, avoid tanning booths and||
0164|106|P|sunlamps, and use sunscreen and wear protective clothing when||
0164|107|P|outdoors. Tell your doctor right away if you get sunburned or||
0164|108|P|have skin blisters/redness.||
0164|109|P|   Some products may worsen acne. If your skin is prone to acne||
0164|110|P|breakouts, look for the word "non-comedogenic" (will not clog||
0164|111|P|pores) on the label. Some products may stain/discolor clothing.||
0164|112|P|Ask your doctor or pharmacist for more details.||
0164|113|P|   Before having surgery, tell your doctor or dentist about all||
0164|114|P|the products you use (including prescription drugs,||
0164|115|P|nonprescription drugs, and herbal products).||
0164|116|P|   Tell your doctor if you are pregnant before using this||
0164|117|P|product.||
0164|118|P|   It is unknown if this product passes into breast milk. Consult||
0164|119|P|your doctor before breastfeeding.||
0164|120|B|||
0164|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0164|122|I|medications work or increase your risk for serious side effects.||
0164|123|I|This document does not contain all possible drug interactions.||
0164|124|I|Keep a list of all the products you use (including||
0164|125|I|prescription/nonprescription drugs and herbal products) and share||
0164|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
0164|127|I|the dosage of any medicines without your doctor's approval.||
0164|128|B|||
0164|129|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0164|130|O|has overdosed and has serious symptoms such as passing out or||
0164|131|O|trouble breathing, call 911. Otherwise, call a poison control||
0164|132|O|center right away. US residents can call 1-800-222-1222. Canada||
0164|133|O|residents can call 1-844-764-7669.||
0164|134|B|||
0164|135|N|NOTES:  Some ways to help prevent dry skin include using lukewarm||
0164|136|N|(not hot) water when bathing, taking baths/showers less often||
0164|137|N|(such as every 1-2 days), keeping baths/showers short, and using||
0164|138|N|a humidifier when the air is very dry.||
0164|139|N|   There are many types of emollient products available. Some||
0164|140|N|contain fragrance or other ingredients that some people may be||
0164|141|N|sensitive to. Emollients are available in different forms such as||
0164|142|N|oils, creams, lotions, or sprays. Consult with your doctor or||
0164|143|N|pharmacist on the product that may be best for you.||
0164|144|B|||
0164|145|D|MISSED DOSE:  If you are using this product on a regular schedule||
0164|146|D|and miss a dose, use it as soon as you remember. Do not use more||
0164|147|D|product or use it more often than directed to catch up.||
0164|148|B|||
0164|149|R|STORAGE:  Refer to storage information printed on the package. If||
0164|150|R|you have any questions about storage, ask your pharmacist. Keep||
0164|151|R|all medications away from children and pets.||
0164|152|R|   Do not flush medications down the toilet or pour them into a||
0164|153|R|drain unless instructed to do so. Properly discard this product||
0164|154|R|when it is expired or no longer needed. Consult your pharmacist||
0164|155|R|or local waste disposal company.||
0164|156|B|||
0164|157|A|Information last revised October 2024.||
0164|158|A|Copyright(c) 2025 First Databank, Inc.||
0164|159|B|||
0165|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0165|002|Z|does NOT have all possible information about this product. This||
0165|003|Z|information does not assure that this product is safe, effective,||
0165|004|Z|or appropriate for you. This information is not individual||
0165|005|Z|medical advice and does not substitute for the advice of your||
0165|006|Z|health care professional. Always ask your health care||
0165|007|Z|professional for complete information about this product and your||
0165|008|Z|specific health needs.||
0165|009|B|||
0165|010|T|PYRIDOSTIGMINE - ORAL||
0165|011|F|(pir-ID-oh-STIG-meen)||
0165|012|B|||
0165|013|C|COMMON BRAND NAME(S): Mestinon||
0165|014|B|||
0165|015|U|USES:  Pyridostigmine is used to improve muscle strength in||
0165|016|U|patients with a certain muscle disease (myasthenia gravis). It||
0165|017|U|works by preventing the breakdown of a certain natural substance||
0165|018|U|(acetylcholine) in your body. Acetylcholine is needed for normal||
0165|019|U|muscle function.||
0165|020|B|||
0165|021|H|HOW TO USE:  Take this medication by mouth with or without food||
0165|022|H|as directed by your doctor. If you are using the liquid form of||
0165|023|H|this medication, carefully measure the dose using a special||
0165|024|H|measuring device/spoon. Do not use a household spoon because you||
0165|025|H|may not get the correct dose.||
0165|026|H|   If you are using the extended-release tablets, take as||
0165|027|H|directed by your doctor, usually 1 to 2 times daily (at least 6||
0165|028|H|hours apart). Do not crush or chew extended-release tablets.||
0165|029|H|Doing so can release all of the drug at once, increasing the risk||
0165|030|H|of side effects. Also, do not split the tablets unless they have||
0165|031|H|a score line and your doctor or pharmacist tells you to do so.||
0165|032|H|Swallow the whole or split tablet without crushing or chewing.||
0165|033|H|   The dosage is based on your medical condition and response to||
0165|034|H|treatment. Use this medication regularly to get the most benefit||
0165|035|H|from it. To help you remember, take it at the same time(s) each||
0165|036|H|day.||
0165|037|H|   Do not increase your dose or use this drug more often or for||
0165|038|H|longer than prescribed. Your condition will not improve any||
0165|039|H|faster, and your risk of side effects will increase.||
0165|040|H|   The tablet forms of this medication may become discolored due||
0165|041|H|to moisture. This does not affect how well the medication works.||
0165|042|H|   Tell your doctor if your condition does not get better or if||
0165|043|H|it gets worse.||
0165|044|B|||
0165|045|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, abdominal cramps,||
0165|046|S|increased saliva/sweating, runny nose, decreased pupil size, or||
0165|047|S|increased urination may occur. If any of these effects last or||
0165|048|S|get worse, tell your doctor or pharmacist promptly.||
0165|049|S|   Remember that this medication has been prescribed because your||
0165|050|S|doctor has judged that the benefit to you is greater than the||
0165|051|S|risk of side effects. Many people using this medication do not||
0165|052|S|have serious side effects.||
0165|053|S|   Tell your doctor right away if you have any serious side||
0165|054|S|effects, including: new or increased muscle||
0165|055|S|cramps/weakness/twitching, slow heartbeat, dizziness.||
0165|056|S|   A very serious allergic reaction to this drug is rare.||
0165|057|S|However, get medical help right away if you notice any symptoms||
0165|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0165|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0165|060|S|breathing.||
0165|061|S|   This is not a complete list of possible side effects. If you||
0165|062|S|notice other effects not listed above, contact your doctor or||
0165|063|S|pharmacist.||
0165|064|S|   In the US -||
0165|065|S|   Call your doctor for medical advice about side effects. You||
0165|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0165|067|S|www.fda.gov/medwatch.||
0165|068|S|   In Canada - Call your doctor for medical advice about side||
0165|069|S|effects. You may report side effects to Health Canada at||
0165|070|S|1-866-234-2345.||
0165|071|B|||
0165|072|P|PRECAUTIONS:  Before taking pyridostigmine, tell your doctor or||
0165|073|P|pharmacist if you are allergic to it; or to bromides; or if you||
0165|074|P|have any other allergies. This product may contain inactive||
0165|075|P|ingredients, which can cause allergic reactions or other||
0165|076|P|problems. Talk to your pharmacist for more details.||
0165|077|P|   Before using this medication, tell your doctor or pharmacist||
0165|078|P|your medical history, especially of: stomach/intestinal blockage,||
0165|079|P|urinary blockage, lung disease (such as asthma, chronic||
0165|080|P|obstructive pulmonary disease-COPD), kidney disease,||
0165|081|P|slow/irregular heartbeat.||
0165|082|P|   Before having surgery, tell your doctor or dentist about all||
0165|083|P|the products you use (including prescription drugs,||
0165|084|P|nonprescription drugs, and herbal products).||
0165|085|P|   Liquid products may contain sugar and/or alcohol. Caution is||
0165|086|P|advised if you have diabetes, liver disease, or any other||
0165|087|P|condition that requires you to limit/avoid these substances in||
0165|088|P|your diet. Ask your doctor or pharmacist about using this product||
0165|089|P|safely.||
0165|090|P|   During pregnancy, this medication should be used only when||
0165|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
0165|092|P|   This medication passes into breast milk but is unlikely to||
0165|093|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0165|094|B|||
0165|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0165|096|I|medications work or increase your risk for serious side effects.||
0165|097|I|This document does not contain all possible drug interactions.||
0165|098|I|Keep a list of all the products you use (including||
0165|099|I|prescription/nonprescription drugs and herbal products) and share||
0165|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
0165|101|I|the dosage of any medicines without your doctor's approval.||
0165|102|B|||
0165|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0165|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0165|105|O|poison control center right away. US residents can call||
0165|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0165|107|O|Symptoms of overdose may include: mental/mood changes (such as||
0165|108|O|agitation, restlessness, confusion, hallucinations), fast/slow||
0165|109|O|heartbeat, muscle cramps/weakness, inability to move, trouble||
0165|110|O|breathing.||
0165|111|B|||
0165|112|N|NOTES:  Do not share this medication with others.||
0165|113|B|||
0165|114|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0165|115|D|remember. If it is near the time of the next dose, skip the||
0165|116|D|missed dose. Take your next dose at the regular time. Do not||
0165|117|D|double the dose to catch up.||
0165|118|B|||
0165|119|R|STORAGE:  Store at room temperature away from light and moisture.||
0165|120|R|Do not store in the bathroom. Keep all medications away from||
0165|121|R|children and pets.||
0165|122|R|   Do not flush medications down the toilet or pour them into a||
0165|123|R|drain unless instructed to do so. Properly discard this product||
0165|124|R|when it is expired or no longer needed. Consult your pharmacist||
0165|125|R|or local waste disposal company.||
0165|126|B|||
0165|127|A|Information last revised May 2024.||
0165|128|A|Copyright(c) 2025 First Databank, Inc.||
0165|129|B|||
0166|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0166|002|Z|does NOT have all possible information about this product. This||
0166|003|Z|information does not assure that this product is safe, effective,||
0166|004|Z|or appropriate for you. This information is not individual||
0166|005|Z|medical advice and does not substitute for the advice of your||
0166|006|Z|health care professional. Always ask your health care||
0166|007|Z|professional for complete information about this product and your||
0166|008|Z|specific health needs.||
0166|009|B|||
0166|010|T|URSODIOL - ORAL||
0166|011|F|(UR-soe-DYE-ol)||
0166|012|B|||
0166|013|C|COMMON BRAND NAME(S): Actigall, Urso||
0166|014|B|||
0166|015|U|USES:  Ursodiol is used to dissolve certain types of gallstones,||
0166|016|U|to prevent gallstones from forming in obese patients who are||
0166|017|U|losing weight rapidly, and to treat a certain type of liver||
0166|018|U|disease (primary biliary cholangitis). Ursodiol is a bile acid.||
0166|019|B|||
0166|020|H|HOW TO USE:  Take this medication exactly as directed by your||
0166|021|H|doctor.||
0166|022|H|   The dosage is based on your medical condition and response to||
0166|023|H|treatment.||
0166|024|H|   Do not increase your dose or take this medication more often||
0166|025|H|without your doctor's approval. Your condition will not improve||
0166|026|H|any faster, and the risk of serious side effects may be||
0166|027|H|increased.||
0166|028|H|   Use this medication regularly to get the most benefit from it.||
0166|029|H|To help you remember, take it at the same times each day.||
0166|030|B|||
0166|031|S|SIDE EFFECTS:  Stomach upset, nausea, diarrhea, dizziness, back||
0166|032|S|pain, hair loss, or cough may occur. If any of these effects last||
0166|033|S|or get worse, tell your doctor or pharmacist promptly.||
0166|034|S|   Remember that this medication has been prescribed because your||
0166|035|S|doctor has judged that the benefit to you is greater than the||
0166|036|S|risk of side effects. Many people using this medication do not||
0166|037|S|have serious side effects.||
0166|038|S|   Tell your doctor right away if you have any serious side||
0166|039|S|effects, including: weakness, swelling of the ankles/feet,||
0166|040|S|increased thirst/urination, signs of infection (such as sore||
0166|041|S|throat that doesn't go away, fever, chills), easy||
0166|042|S|bleeding/bruising, symptoms of stomach/intestinal blockage (such||
0166|043|S|as abdominal pain, loss of appetite, cramping, vomiting).||
0166|044|S|   A very serious allergic reaction to this drug is rare.||
0166|045|S|However, get medical help right away if you notice any symptoms||
0166|046|S|of a serious allergic reaction, including: rash, itching/swelling||
0166|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0166|048|S|breathing.||
0166|049|S|   This is not a complete list of possible side effects. If you||
0166|050|S|notice other effects not listed above, contact your doctor or||
0166|051|S|pharmacist.||
0166|052|S|   In the US -||
0166|053|S|   Call your doctor for medical advice about side effects. You||
0166|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0166|055|S|www.fda.gov/medwatch.||
0166|056|S|   In Canada - Call your doctor for medical advice about side||
0166|057|S|effects. You may report side effects to Health Canada at||
0166|058|S|1-866-234-2345.||
0166|059|B|||
0166|060|P|PRECAUTIONS:  Before taking ursodiol, tell your doctor or||
0166|061|P|pharmacist if you are allergic to it; or to other bile acids; or||
0166|062|P|if you have any other allergies. This product may contain||
0166|063|P|inactive ingredients, which can cause allergic reactions or other||
0166|064|P|problems. Talk to your pharmacist for more details.||
0166|065|P|   Before using this medication, tell your doctor or pharmacist||
0166|066|P|your medical history, especially of: certain gallbladder/bile||
0166|067|P|duct problems (such as acute cholecystitis, cholangitis, biliary||
0166|068|P|obstruction, gallstone pancreatitis, biliary-gastrointestinal||
0166|069|P|fistula), liver disease (such as ascites, variceal bleeding,||
0166|070|P|hepatic encephalopathy).||
0166|071|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0166|072|P|can make you more dizzy. Do not drive, use machinery, or do||
0166|073|P|anything that needs alertness until you can do it safely. Limit||
0166|074|P|alcoholic beverages. Talk to your doctor if you are using||
0166|075|P|marijuana (cannabis).||
0166|076|P|   During pregnancy, this medication should be used only when||
0166|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
0166|078|P|   This medication passes into breast milk. Consult your doctor||
0166|079|P|before breastfeeding.||
0166|080|B|||
0166|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0166|082|I|medications work or increase your risk for serious side effects.||
0166|083|I|This document does not contain all possible drug interactions.||
0166|084|I|Keep a list of all the products you use (including||
0166|085|I|prescription/nonprescription drugs and herbal products) and share||
0166|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
0166|087|I|the dosage of any medicines without your doctor's approval.||
0166|088|B|||
0166|089|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0166|090|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0166|091|O|poison control center right away. US residents can call||
0166|092|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0166|093|O|Symptoms of overdose may include: severe diarrhea.||
0166|094|B|||
0166|095|N|NOTES:  Do not share this medication with others.||
0166|096|N|   Lab and/or medical tests (such as liver function, bilirubin||
0166|097|N|level) should be done while you are taking this medication. Keep||
0166|098|N|all medical and lab appointments. Consult your doctor for more||
0166|099|N|details.||
0166|100|B|||
0166|101|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0166|102|D|remember. If it is near the time of the next dose, skip the||
0166|103|D|missed dose. Take your next dose at the regular time. Do not||
0166|104|D|double the dose to catch up.||
0166|105|B|||
0166|106|R|STORAGE:  Store at room temperature away from light and moisture.||
0166|107|R|Different brands/strengths of this medication may have different||
0166|108|R|storage requirements. Read the package labeling or ask your||
0166|109|R|pharmacist for the storage requirements for the product you are||
0166|110|R|using. Do not store in the bathroom. Keep all medications away||
0166|111|R|from children and pets.||
0166|112|R|   Do not flush medications down the toilet or pour them into a||
0166|113|R|drain unless instructed to do so. Properly discard this product||
0166|114|R|when it is expired or no longer needed. Consult your pharmacist||
0166|115|R|or local waste disposal company.||
0166|116|B|||
0166|117|A|Information last revised April 2025.||
0166|118|A|Copyright(c) 2025 First Databank, Inc.||
0166|119|B|||
0167|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0167|002|Z|does NOT have all possible information about this product. This||
0167|003|Z|information does not assure that this product is safe, effective,||
0167|004|Z|or appropriate for you. This information is not individual||
0167|005|Z|medical advice and does not substitute for the advice of your||
0167|006|Z|health care professional. Always ask your health care||
0167|007|Z|professional for complete information about this product and your||
0167|008|Z|specific health needs.||
0167|009|B|||
0167|010|T|FINASTERIDE - ORAL||
0167|011|F|(fin-AS-ter-ide)||
0167|012|B|||
0167|013|C|COMMON BRAND NAME(S): Proscar||
0167|014|B|||
0167|015|U|USES:  Finasteride is used to shrink an enlarged prostate (benign||
0167|016|U|prostatic hyperplasia or BPH) in adult men. It may be used alone||
0167|017|U|or taken in combination with other medications to reduce symptoms||
0167|018|U|of BPH and may also reduce the need for surgery.||
0167|019|U|   Finasteride may improve symptoms of BPH and provide benefits||
0167|020|U|such as decreased urge to urinate, better urine flow with less||
0167|021|U|straining, less of a feeling that the bladder is not completely||
0167|022|U|emptied, and decreased nighttime urination. This medication works||
0167|023|U|by decreasing the amount of a natural body hormone (DHT) that||
0167|024|U|causes growth of the prostate.||
0167|025|U|   Women and children should not use this medication.||
0167|026|B|||
0167|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0167|028|H|from your pharmacist before you start taking finasteride and each||
0167|029|H|time you get a refill. If you have any questions, ask your doctor||
0167|030|H|or pharmacist.||
0167|031|H|   Take this medication by mouth with or without food as directed||
0167|032|H|by your doctor, usually once a day.||
0167|033|H|   Since this drug can be absorbed through the skin and lungs and||
0167|034|H|may harm an unborn baby, women who are pregnant or who may become||
0167|035|H|pregnant should not handle this medication or breathe the dust||
0167|036|H|from the tablets. It may cause abnormal sex organ development in||
0167|037|H|an unborn male infant.||
0167|038|H|   Use this medication regularly to get the most benefit from it.||
0167|039|H|Remember to use it at the same time each day. Do not stop taking||
0167|040|H|this medication without consulting your doctor. It may take 6 to||
0167|041|H|12 months to notice a benefit.||
0167|042|H|   Tell your doctor if your condition does not get better or if||
0167|043|H|it gets worse.||
0167|044|B|||
0167|045|S|SIDE EFFECTS:  Decreased sexual ability/desire may occur. In some||
0167|046|S|men, this medication can decrease the amount of semen released||
0167|047|S|during sex. This is harmless, but has continued in some men even||
0167|048|S|after stopping treatment. Finasteride may also increase hair||
0167|049|S|growth. If any of these effects last or get worse, notify your||
0167|050|S|doctor or pharmacist promptly.||
0167|051|S|   Remember that this medication has been prescribed because your||
0167|052|S|doctor has judged that the benefit to you is greater than the||
0167|053|S|risk of side effects. Many people using this medication do not||
0167|054|S|have serious side effects.||
0167|055|S|   Tell your doctor right away if you have any serious side||
0167|056|S|effects, including: lump in the breast, nipple discharge, breast||
0167|057|S|enlargement/tenderness/pain, pain in the testicles, inability to||
0167|058|S|urinate.||
0167|059|S|   A very serious allergic reaction to this drug is rare.||
0167|060|S|However, get medical help right away if you notice any symptoms||
0167|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0167|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0167|063|S|breathing.||
0167|064|S|   This is not a complete list of possible side effects. If you||
0167|065|S|notice other effects not listed above, contact your doctor or||
0167|066|S|pharmacist.||
0167|067|S|   In the US -||
0167|068|S|   Call your doctor for medical advice about side effects. You||
0167|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0167|070|S|www.fda.gov/medwatch.||
0167|071|S|   In Canada - Call your doctor for medical advice about side||
0167|072|S|effects. You may report side effects to Health Canada at||
0167|073|S|1-866-234-2345.||
0167|074|B|||
0167|075|P|PRECAUTIONS:  Before taking finasteride, tell your doctor or||
0167|076|P|pharmacist if you are allergic to it; or if you have any other||
0167|077|P|allergies. This product may contain inactive ingredients, which||
0167|078|P|can cause allergic reactions or other problems. Talk to your||
0167|079|P|pharmacist for more details.||
0167|080|P|   Before using this medication, tell your doctor or pharmacist||
0167|081|P|your medical history, especially of: liver disease, prostate||
0167|082|P|cancer, infections, urinary problems.||
0167|083|P|   Before having surgery, tell your doctor or dentist about all||
0167|084|P|the products you use (including prescription drugs,||
0167|085|P|nonprescription drugs, and herbal products).||
0167|086|P|   Finasteride should not be used in women, especially during||
0167|087|P|pregnancy or breastfeeding. It may harm an unborn or||
0167|088|P|breastfeeding baby. Consult your doctor if you have any questions||
0167|089|P|about this medication.||
0167|090|B|||
0167|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0167|092|I|medications work or increase your risk for serious side effects.||
0167|093|I|This document does not contain all possible drug interactions.||
0167|094|I|Keep a list of all the products you use (including||
0167|095|I|prescription/nonprescription drugs and herbal products) and share||
0167|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
0167|097|I|the dosage of any medicines without your doctor's approval.||
0167|098|I|   This medication may interfere with certain lab tests (such as||
0167|099|I|PSA levels), possibly causing false test results. Make sure lab||
0167|100|I|personnel and all your doctors know you use this drug.||
0167|101|B|||
0167|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0167|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0167|104|O|poison control center right away. US residents can call||
0167|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0167|106|B|||
0167|107|N|NOTES:  Do not share this medication with others.||
0167|108|N|   Lab and/or medical tests (such as prostate exams, PSA levels)||
0167|109|N|should be done while you are taking this medication. Keep all||
0167|110|N|medical and lab appointments. Follow your doctor's instructions||
0167|111|N|for examining your breasts and testicles, and report any lumps||
0167|112|N|right away. Consult your doctor for more details.||
0167|113|B|||
0167|114|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0167|115|D|remember. If it is near the time of the next dose, skip the||
0167|116|D|missed dose. Take your next dose at the regular time. Do not||
0167|117|D|double the dose to catch up.||
0167|118|B|||
0167|119|R|STORAGE:  Store at room temperature away from light and moisture.||
0167|120|R|Do not store in the bathroom. Keep all medications away from||
0167|121|R|children and pets.||
0167|122|R|   Do not flush medications down the toilet or pour them into a||
0167|123|R|drain unless instructed to do so. Properly discard this product||
0167|124|R|when it is expired or no longer needed. Consult your pharmacist||
0167|125|R|or local waste disposal company.||
0167|126|B|||
0167|127|A|Information last revised August 2025.||
0167|128|A|Copyright(c) 2025 First Databank, Inc.||
0167|129|B|||
0168|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0168|002|Z|does NOT have all possible information about this product. This||
0168|003|Z|information does not assure that this product is safe, effective,||
0168|004|Z|or appropriate for you. This information is not individual||
0168|005|Z|medical advice and does not substitute for the advice of your||
0168|006|Z|health care professional. Always ask your health care||
0168|007|Z|professional for complete information about this product and your||
0168|008|Z|specific health needs.||
0168|009|B|||
0168|010|T|BETAXOLOL SUSPENSION - OPHTHALMIC||
0168|011|F|(be-TAX-oh-lol)||
0168|012|B|||
0168|013|C|COMMON BRAND NAME(S): Betoptic S||
0168|014|B|||
0168|015|U|USES:  This medication is used alone or with other medications to||
0168|016|U|treat high pressure inside the eye due to glaucoma (open-angle||
0168|017|U|type) or other eye diseases (such as ocular hypertension).||
0168|018|U|Lowering high pressure inside the eye helps to prevent blindness.||
0168|019|U|Betaxolol belongs to a class of drugs known as beta blockers and||
0168|020|U|works by decreasing the amount of fluid that is made within the||
0168|021|U|eye.||
0168|022|B|||
0168|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0168|024|H|directed by your doctor, usually twice daily.||
0168|025|H|   To apply eye drops, wash your hands first. To avoid||
0168|026|H|contamination, do not touch the dropper tip or let it touch your||
0168|027|H|eye or any other surface.||
0168|028|H|   If you are wearing contact lenses, remove them before using||
0168|029|H|eye drops. Wait at least 15 minutes before replacing your contact||
0168|030|H|lenses.||
0168|031|H|   Shake the bottle well before using. Tilt your head back, look||
0168|032|H|upward, and pull down the lower eyelid to make a pouch. Hold the||
0168|033|H|dropper directly over your eye and place one drop into the pouch.||
0168|034|H|Look downward and gently close your eyes for 1 to 2 minutes.||
0168|035|H|Place one finger at the corner of your eye (near the nose) and||
0168|036|H|apply gentle pressure. This will prevent the medication from||
0168|037|H|draining out. Try not to blink and do not rub your eye. Repeat||
0168|038|H|these steps for your other eye if so directed or if your dose is||
0168|039|H|for more than 1 drop.||
0168|040|H|   Do not rinse the dropper. Replace the dropper cap after each||
0168|041|H|use.||
0168|042|H|   If you are using another kind of eye medication (such as drops||
0168|043|H|or ointments), wait at least 10 minutes before using the other||
0168|044|H|medications. Use eye drops before eye ointments to allow the eye||
0168|045|H|drops to enter the eye.||
0168|046|H|   Wait several minutes for your vision to clear before driving||
0168|047|H|or operating machinery.||
0168|048|H|   Use this medication regularly in order to get the most benefit||
0168|049|H|from it. To help you remember, use it at the same times each day.||
0168|050|H|Keep using this medication even if you feel well. Most people||
0168|051|H|with glaucoma or high pressure in the eyes do not feel sick.||
0168|052|B|||
0168|053|S|SIDE EFFECTS:  Temporary stinging/discomfort of the eye,||
0168|054|S|watery/dry/itchy/red eyes, blurred vision, feeling as if||
0168|055|S|something is in the eye, crusting of eyelashes, headache, trouble||
0168|056|S|sleeping, or dizziness may occur. If any of these effects last or||
0168|057|S|get worse, tell your doctor or pharmacist promptly.||
0168|058|S|   Remember that this medication has been prescribed because your||
0168|059|S|doctor has judged that the benefit to you is greater than the||
0168|060|S|risk of side effects. Many people using this medication do not||
0168|061|S|have serious side effects.||
0168|062|S|   Tell your doctor right away if you have any serious side||
0168|063|S|effects, including: eye pain/swelling/discharge, vision changes,||
0168|064|S|increased eye sensitivity to light, swelling of the ankles/feet,||
0168|065|S|tiredness, slow/irregular heartbeat, muscle weakness, mental/mood||
0168|066|S|changes, hair loss, blue fingers/toes, cold hands/feet.||
0168|067|S|   Get medical help right away if you have any very serious side||
0168|068|S|effects, including: dizziness that doesn't stop, trouble||
0168|069|S|breathing, sudden unexplained weight gain, chest pain, weakness||
0168|070|S|on one side of the body, trouble speaking, confusion, fainting.||
0168|071|S|   A very serious allergic reaction to this drug is rare.||
0168|072|S|However, get medical help right away if you notice any symptoms||
0168|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0168|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0168|075|S|breathing.||
0168|076|S|   This is not a complete list of possible side effects. If you||
0168|077|S|notice other effects not listed above, contact your doctor or||
0168|078|S|pharmacist.||
0168|079|S|   In the US -||
0168|080|S|   Call your doctor for medical advice about side effects. You||
0168|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0168|082|S|www.fda.gov/medwatch.||
0168|083|S|   In Canada - Call your doctor for medical advice about side||
0168|084|S|effects. You may report side effects to Health Canada at||
0168|085|S|1-866-234-2345.||
0168|086|B|||
0168|087|P|PRECAUTIONS:  Before using betaxolol, tell your doctor or||
0168|088|P|pharmacist if you are allergic to it; or to other beta blockers||
0168|089|P|(such as timolol, metipranolol); or if you have any other||
0168|090|P|allergies. This product may contain inactive ingredients (such as||
0168|091|P|preservatives like benzalkonium chloride), which can cause||
0168|092|P|allergic reactions or other problems. Talk to your pharmacist for||
0168|093|P|more details.||
0168|094|P|   Before using this medication, tell your doctor or pharmacist||
0168|095|P|your medical history, especially of: diabetes, low blood sugar||
0168|096|P|levels (hypoglycemia), overactive thyroid (hyperthyroidism),||
0168|097|P|muscle weakness disorders (such as myasthenia gravis), breathing||
0168|098|P|problems (such as asthma, chronic obstructive pulmonary||
0168|099|P|disease-COPD), heart problems (such as heart failure, slow||
0168|100|P|heartbeat, second- or third-degree atrioventricular block), low||
0168|101|P|blood flow to the brain (cerebrovascular insufficiency), poor||
0168|102|P|blood flow to the hands/feet (Raynaud's phenomenon), severe||
0168|103|P|allergies.||
0168|104|P|   If you develop an eye infection or injury, or have eye||
0168|105|P|surgery, check with your doctor about whether you should continue||
0168|106|P|to use your current bottle of betaxolol. You may be advised to||
0168|107|P|start using a new bottle.||
0168|108|P|   Before having surgery, tell your doctor or dentist about all||
0168|109|P|the products you use (including prescription drugs,||
0168|110|P|nonprescription drugs, and herbal products).||
0168|111|P|   This drug may make you dizzy or temporarily blur your vision.||
0168|112|P|Do not drive, use machinery, or do anything that needs alertness||
0168|113|P|or clear vision until you can do it safely. Limit alcoholic||
0168|114|P|beverages. Talk to your doctor if you are using marijuana||
0168|115|P|(cannabis).||
0168|116|P|   This product may prevent the fast/pounding heartbeat you would||
0168|117|P|usually feel when your blood sugar level falls too low||
0168|118|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0168|119|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0168|120|P|blood sugar level, such as dizziness and sweating, are not||
0168|121|P|affected by this drug.||
0168|122|P|   If you have diabetes, this product may make it harder to||
0168|123|P|control your blood sugar levels. Check your blood sugar levels||
0168|124|P|regularly as directed by your doctor. Tell your doctor right away||
0168|125|P|if you have symptoms of high blood sugar such as increased||
0168|126|P|thirst/urination. Your doctor may need to adjust your diabetes||
0168|127|P|medication, exercise program, or diet.||
0168|128|P|   During pregnancy, this medication should be used only when||
0168|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
0168|130|P|   It is unknown if this medication passes into breast milk.||
0168|131|P|Consult your doctor before breastfeeding.||
0168|132|B|||
0168|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0168|134|I|medications work or increase your risk for serious side effects.||
0168|135|I|This document does not contain all possible drug interactions.||
0168|136|I|Keep a list of all the products you use (including||
0168|137|I|prescription/nonprescription drugs and herbal products) and share||
0168|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
0168|139|I|the dosage of any medicines without your doctor's approval.||
0168|140|I|   Some products that may interact with this drug are: drugs for||
0168|141|I|high blood pressure (including clonidine, oral beta blockers such||
0168|142|I|as propranolol, calcium channel blockers such as diltiazem),||
0168|143|I|epinephrine.||
0168|144|B|||
0168|145|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0168|146|O|has overdosed and has serious symptoms such as passing out or||
0168|147|O|trouble breathing, call 911. Otherwise, call a poison control||
0168|148|O|center right away. US residents can call 1-800-222-1222. Canada||
0168|149|O|residents can call 1-844-764-7669. If this product is||
0168|150|O|accidentally swallowed, you may experience symptoms such as||
0168|151|O|trouble breathing, slow/irregular heartbeat.||
0168|152|B|||
0168|153|N|NOTES:  Do not share this medication with others.||
0168|154|N|   Lab and/or medical tests (such as eye exams) should be done||
0168|155|N|while you are using this medication. Keep all medical and lab||
0168|156|N|appointments. Consult your doctor for more details.||
0168|157|B|||
0168|158|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0168|159|D|If it is near the time of the next dose, skip the missed dose.||
0168|160|D|Use your next dose at the regular time. Do not double the dose to||
0168|161|D|catch up.||
0168|162|B|||
0168|163|R|STORAGE:  Store upright in the refrigerator or at room||
0168|164|R|temperature. Keep all medications away from children and pets.||
0168|165|R|   Do not flush medications down the toilet or pour them into a||
0168|166|R|drain unless instructed to do so. Properly discard this product||
0168|167|R|when it is expired or no longer needed. Consult your pharmacist||
0168|168|R|or local waste disposal company.||
0168|169|B|||
0168|170|A|Information last revised May 2024.||
0168|171|A|Copyright(c) 2025 First Databank, Inc.||
0168|172|B|||
0169|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0169|002|Z|does NOT have all possible information about this product. This||
0169|003|Z|information does not assure that this product is safe, effective,||
0169|004|Z|or appropriate for you. This information is not individual||
0169|005|Z|medical advice and does not substitute for the advice of your||
0169|006|Z|health care professional. Always ask your health care||
0169|007|Z|professional for complete information about this product and your||
0169|008|Z|specific health needs.||
0169|009|B|||
0169|010|T|TYPHOID VACCINE ENTERIC-COATED CAPSULE - ORAL||
0169|011|F|(tye-FOYD vak-SEEN)||
0169|012|B|||
0169|013|C|COMMON BRAND NAME(S): Vivotif Berna||
0169|014|B|||
0169|015|U|USES:  This vaccine is used to help prevent typhoid fever.||
0169|016|U|Typhoid fever is an infection that can be spread by eating||
0169|017|U|contaminated food or drinking contaminated water.||
0169|018|U|   This vaccine is recommended for people who are traveling to||
0169|019|U|areas where the infection is common (such as Africa, Asia,||
0169|020|U|Central/South America), those who are in close contact to someone||
0169|021|U|with an ongoing typhoid infection, and those who work with the||
0169|022|U|bacteria (Salmonella typhi) in a lab.||
0169|023|U|   This vaccine contains live bacteria that have been weakened.||
0169|024|U|It works by increasing the body's natural defense (immunity)||
0169|025|U|against the bacteria.||
0169|026|U|   Vaccines may not fully protect everyone who receives them.||
0169|027|B|||
0169|028|H|HOW TO USE:  Read all vaccine information available from your||
0169|029|H|health care professional before taking the vaccine. If you have||
0169|030|H|any questions, ask your health care professional.||
0169|031|H|   Before taking each dose, inspect the foil blister pack to make||
0169|032|H|sure it is completely sealed. Carefully open the blister pack and||
0169|033|H|inspect the capsule to make sure it is not damaged. Consult your||
0169|034|H|health care professional if the foil blister pack or capsule is||
0169|035|H|damaged.||
0169|036|H|   Take this medication by mouth without food as directed by your||
0169|037|H|health care professional, usually every other day for 4 doses.||
0169|038|H|Swallow the capsule whole with cold or barely warm liquid about 1||
0169|039|H|hour before a meal. Place the capsule in your mouth and swallow||
0169|040|H|with the liquid right away. Do not chew, crush, or hold the||
0169|041|H|capsule in your mouth.||
0169|042|H|   Follow the dosing schedule closely for the vaccine to get the||
0169|043|H|most benefit from it. To help you remember, mark your calendar||
0169|044|H|with a reminder. You should complete your course of the vaccine||
0169|045|H|at least 1 week before possible exposure to typhoid fever. The||
0169|046|H|vaccine can be taken every 5 years thereafter if needed.||
0169|047|H|   This vaccine should not be taken at the same time as other||
0169|048|H|vaccines taken by mouth (such as cholera vaccine).||
0169|049|B|||
0169|050|S|SIDE EFFECTS:  Nausea may occur. If this effect lasts or gets||
0169|051|S|worse, tell your health care professional promptly.||
0169|052|S|   Remember that this vaccine has been prescribed because your||
0169|053|S|health care professional has judged that the benefit to you is||
0169|054|S|greater than the risk of side effects. Many people using this||
0169|055|S|vaccine do not have serious side effects.||
0169|056|S|   A very serious allergic reaction to this vaccine is rare.||
0169|057|S|However, get medical help right away if you notice any symptoms||
0169|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0169|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0169|060|S|breathing.||
0169|061|S|   This is not a complete list of possible side effects. If you||
0169|062|S|notice other effects not listed above, contact health care||
0169|063|S|professional.||
0169|064|S|   Contact the health care professional for medical advice about||
0169|065|S|side effects. The following numbers do not provide medical||
0169|066|S|advice, but in the US you may report side effects to the Vaccine||
0169|067|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
0169|068|S|Canada, you may call the Vaccine Safety Section at Public Health||
0169|069|S|Agency of Canada at 1-866-844-0018.||
0169|070|B|||
0169|071|P|PRECAUTIONS:  Before taking the typhoid vaccine, tell the health||
0169|072|P|care professional if you are allergic to it; or if you have any||
0169|073|P|other allergies. This product may contain inactive ingredients,||
0169|074|P|which can cause allergic reactions or other problems. Talk to||
0169|075|P|your health care professional for more details.||
0169|076|P|   Before taking this vaccine, tell your health care professional||
0169|077|P|your medical history, especially of: current fever/illness,||
0169|078|P|current stomach problems (such as vomiting/diarrhea that doesn't||
0169|079|P|stop), immune system disorders (such as due to HIV infection,||
0169|080|P|certain cancers such as leukemia/lymphoma, cancer or radiation||
0169|081|P|treatment), vaccination history (including previous reactions to||
0169|082|P|any vaccines).||
0169|083|P|   This vaccine is not recommended for use during pregnancy.||
0169|084|P|Discuss the risks and benefits with your health care||
0169|085|P|professional.||
0169|086|P|   It is unknown if this vaccine passes into breast milk. Consult||
0169|087|P|your health care professional before breastfeeding.||
0169|088|B|||
0169|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0169|090|I|medications work or increase your risk for serious side effects.||
0169|091|I|This document does not contain all possible drug interactions.||
0169|092|I|Keep a list of all the products you use (including||
0169|093|I|prescription/nonprescription drugs and herbal products) and share||
0169|094|I|it with your health care professional. Do not start, stop, or||
0169|095|I|change the dosage of any medicines without your doctor's||
0169|096|I|approval.||
0169|097|I|   Some products that may interact with this vaccine are:||
0169|098|I|antibiotics (such as sulfamethoxazole), drugs that weaken the||
0169|099|I|immune system (such as cyclosporine, tacrolimus, cancer||
0169|100|I|chemotherapy, corticosteroids such as prednisone).||
0169|101|B|||
0169|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0169|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0169|104|O|poison control center right away. US residents can call||
0169|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0169|106|B|||
0169|107|N|NOTES:  Do not share this vaccine with others.||
0169|108|N|   Keep vaccine records for yourself and your children and||
0169|109|N|provide them to the health care professionals to prevent||
0169|110|N|unnecessary re-vaccinations.||
0169|111|B|||
0169|112|D|MISSED DOSE:  It is important to take each dose of this vaccine||
0169|113|D|as scheduled. If you miss a dose, ask your health care||
0169|114|D|professional right away for a new dosing schedule. Do not double||
0169|115|D|the dose to catch up.||
0169|116|B|||
0169|117|R|STORAGE:  Store in the refrigerator away from light and moisture.||
0169|118|R|Do not freeze. Keep all medications away from children and pets.||
0169|119|R|   Do not flush medications down the toilet or pour them into a||
0169|120|R|drain unless instructed to do so. Properly discard this product||
0169|121|R|when it is expired or no longer needed. Consult your pharmacist||
0169|122|R|or local waste disposal company.||
0169|123|B|||
0169|124|A|Information last revised February 2025.||
0169|125|A|Copyright(c) 2025 First Databank, Inc.||
0169|126|B|||
0170|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0170|002|Z|does NOT have all possible information about this product. This||
0170|003|Z|information does not assure that this product is safe, effective,||
0170|004|Z|or appropriate for you. This information is not individual||
0170|005|Z|medical advice and does not substitute for the advice of your||
0170|006|Z|health care professional. Always ask your health care||
0170|007|Z|professional for complete information about this product and your||
0170|008|Z|specific health needs.||
0170|009|B|||
0170|010|T|LIDOCAINE VISCOUS - ORAL||
0170|011|F|(LYE-doe-kane)||
0170|012|B|||
0170|013|C|COMMON BRAND NAME(S): Xylocaine Viscous||
0170|014|B|||
0170|015|W|WARNING:  Use of this medication by children younger than 3 years||
0170|016|W|has caused serious (sometimes fatal) side effects, including||
0170|017|W|seizure and slowed/stopped heart. If this medication is||
0170|018|W|prescribed for use by a child younger than 3 years, carefully||
0170|019|W|follow the doctor's directions. Do not increase the dose or give||
0170|020|W|this medication more often than directed. Do not use this||
0170|021|W|medication to treat teething pain in infants and young children||
0170|022|W|unless directed by the doctor. Talk with the doctor about other||
0170|023|W|ways to treat teething pain. Keep this product in a safe place||
0170|024|W|away from children.||
0170|025|B|||
0170|026|U|USES:  See also Warning section.||
0170|027|U|   Viscous lidocaine is used to relieve pain and discomfort from||
0170|028|U|a sore throat/mouth. It is also used to numb the lining of the||
0170|029|U|mouth and throat before certain medical/dental procedures (such||
0170|030|U|as dental impressions). This numbing helps prevent the urge to||
0170|031|U|close the throat (gag reflex), which might make the procedure||
0170|032|U|more difficult. Lidocaine belongs to a class of drugs known as||
0170|033|U|local anesthetics.||
0170|034|B|||
0170|035|V|OTHER USES:  This section contains uses of this drug that are not||
0170|036|V|listed in the approved professional labeling for the drug but||
0170|037|V|that may be prescribed by your health care professional. Use this||
0170|038|V|drug for a condition that is listed in this section only if it||
0170|039|V|has been so prescribed by your health care professional.||
0170|040|V|   This medication may also be used to relieve pain and||
0170|041|V|discomfort from irritation of the esophagus (esophagitis).||
0170|042|B|||
0170|043|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0170|044|H|from your pharmacist before you start using lidocaine and each||
0170|045|H|time you get a refill. If you have any questions, ask your doctor||
0170|046|H|or pharmacist.||
0170|047|H|   Shake the bottle well before each dose. Carefully measure the||
0170|048|H|dose using a special measuring device/spoon. Do not use a||
0170|049|H|household spoon because you may not get the correct dose. Do not||
0170|050|H|mix with other liquid or food unless directed by your doctor.||
0170|051|H|   Use this medication as directed by your doctor, usually as||
0170|052|H|needed for pain or soreness. For mouth pain, swish the dose in||
0170|053|H|your mouth, then spit out. To treat a sore throat, gargle with||
0170|054|H|the medication, then swallow or spit out, as directed by your||
0170|055|H|doctor. To treat irritation of the esophagus, swallow the dose as||
0170|056|H|directed by your doctor. Children should not swallow this||
0170|057|H|medication unless directed by their doctor.||
0170|058|H|   The dosage is based on your medical condition and response to||
0170|059|H|treatment. Children's dosage is also based on age and weight. Do||
0170|060|H|not increase your dose or use this drug more often or for longer||
0170|061|H|than prescribed, because your risk of side effects will increase.||
0170|062|H|Overdose has occurred in children accidentally given the wrong||
0170|063|H|dose. Follow the doctor's instructions carefully.||
0170|064|H|   For infants and children younger than 3 years, carefully||
0170|065|H|measure the prescribed dose and apply to the affected area with a||
0170|066|H|cotton swab. Wait at least 3 hours before giving the next dose.||
0170|067|H|See also Warning section.||
0170|068|H|   This medication numbs the mouth and throat. Numbness may make||
0170|069|H|swallowing difficult and increase your risk of swallowing the||
0170|070|H|wrong way or choking. Do not chew gum or eat for 1 hour after||
0170|071|H|using this product and while your mouth or throat is numb. It is||
0170|072|H|especially important for children to not eat or chew gum for at||
0170|073|H|least 1 hour after using this product. Be careful not to||
0170|074|H|accidentally bite your tongue or mouth.||
0170|075|H|   Lidocaine starts to numb the affected area within 5 minutes||
0170|076|H|after use. If you are using this product before certain||
0170|077|H|procedures, tell your doctor if the area does not feel numb or||
0170|078|H|the numbness does not go away. If you are using this product to||
0170|079|H|relieve pain/discomfort, tell your doctor if your condition lasts||
0170|080|H|or gets worse.||
0170|081|B|||
0170|082|S|SIDE EFFECTS:  Mild nausea, stinging, or burning may occur. If||
0170|083|S|any of these effects last or get worse, tell your doctor or||
0170|084|S|pharmacist promptly.||
0170|085|S|   Remember that this medication has been prescribed because your||
0170|086|S|doctor has judged that the benefit to you is greater than the||
0170|087|S|risk of side effects. Many people using this medication do not||
0170|088|S|have serious side effects.||
0170|089|S|   This medication may cause very serious side effects if you are||
0170|090|S|using too much of it or are very sensitive to its effects. Stop||
0170|091|S|using this medication and get medical help right away if you have||
0170|092|S|any very serious side effects, including: dizziness, drowsiness,||
0170|093|S|slow/shallow breathing, mental/mood changes (such as confusion,||
0170|094|S|nervousness), shaking, seizures, vision changes (such as||
0170|095|S|double/blurred vision), ringing in the ears, fainting,||
0170|096|S|pale/bluish/gray skin, unusual tiredness, shortness of breath,||
0170|097|S|fast/slow/irregular heartbeat.||
0170|098|S|   A very serious allergic reaction to this drug is rare.||
0170|099|S|However, get medical help right away if you notice any symptoms||
0170|100|S|of a serious allergic reaction, including: rash, itching/swelling||
0170|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0170|102|S|breathing.||
0170|103|S|   This is not a complete list of possible side effects. If you||
0170|104|S|notice other effects not listed above, contact your doctor or||
0170|105|S|pharmacist.||
0170|106|S|   In the US -||
0170|107|S|   Call your doctor for medical advice about side effects. You||
0170|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0170|109|S|www.fda.gov/medwatch.||
0170|110|S|   In Canada - Call your doctor for medical advice about side||
0170|111|S|effects. You may report side effects to Health Canada at||
0170|112|S|1-866-234-2345.||
0170|113|B|||
0170|114|P|PRECAUTIONS:  Before using lidocaine, tell your doctor or||
0170|115|P|pharmacist if you are allergic to it; or to other anesthetics||
0170|116|P|(such as bupivacaine, prilocaine); or to PABA; or if you have any||
0170|117|P|other allergies. This product may contain inactive ingredients,||
0170|118|P|which can cause allergic reactions or other problems. Talk to||
0170|119|P|your pharmacist for more details.||
0170|120|P|   Before using this medication, tell your doctor or pharmacist||
0170|121|P|your medical history, especially of: cuts/sores/bleeding in the||
0170|122|P|mouth or throat, heart problems (such as slow/irregular||
0170|123|P|heartbeat, heart block), kidney disease, liver disease, a certain||
0170|124|P|blood disorder (methemoglobinemia).||
0170|125|P|   This drug may make you dizzy or drowsy or cause vision||
0170|126|P|problems if you are using too much of it or are very sensitive to||
0170|127|P|its effects. See Side Effects section. Alcohol or marijuana||
0170|128|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0170|129|P|machinery, or do anything that needs alertness or clear vision||
0170|130|P|until you can do it safely. Limit alcoholic beverages. Talk to||
0170|131|P|your doctor if you are using marijuana (cannabis).||
0170|132|P|   Before having surgery, tell your doctor or dentist about all||
0170|133|P|the products you use (including prescription drugs,||
0170|134|P|nonprescription drugs, and herbal products).||
0170|135|P|   Children may be more sensitive to the side effects of this||
0170|136|P|drug, especially dizziness and drowsiness.||
0170|137|P|   During pregnancy, this medication should be used only when||
0170|138|P|clearly needed. Discuss the risks and benefits with your doctor.||
0170|139|P|   This medication passes into breast milk, but is unlikely to||
0170|140|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0170|141|B|||
0170|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0170|143|I|medications work or increase your risk for serious side effects.||
0170|144|I|This document does not contain all possible drug interactions.||
0170|145|I|Keep a list of all the products you use (including||
0170|146|I|prescription/nonprescription drugs and herbal products) and share||
0170|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
0170|148|I|the dosage of any medicines without your doctor's approval.||
0170|149|I|   Tell your doctor or pharmacist if you are using other||
0170|150|I|lidocaine products at the same time as this medication because||
0170|151|I|your risk of serious side effects may increase.||
0170|152|B|||
0170|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0170|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0170|155|O|poison control center right away. US residents can call||
0170|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0170|157|O|Symptoms of overdose may include: vision/hearing changes, severe||
0170|158|O|dizziness/drowsiness, fainting, loss of consciousness, shaking,||
0170|159|O|seizures, slow/irregular heartbeat, slow/shallow breathing.||
0170|160|B|||
0170|161|N|NOTES:  Do not share this medication with others.||
0170|162|N|   This medication has been prescribed for your current condition||
0170|163|N|only. Do not use it later for another condition unless your||
0170|164|N|doctor directs you to do so. A different medication may be||
0170|165|N|necessary in that case.||
0170|166|B|||
0170|167|D|MISSED DOSE:  Not applicable.||
0170|168|B|||
0170|169|R|STORAGE:  Store at room temperature away from light and moisture.||
0170|170|R|Do not freeze. Do not store in the bathroom. Keep all medications||
0170|171|R|away from children and pets.||
0170|172|R|   Do not flush medications down the toilet or pour them into a||
0170|173|R|drain unless instructed to do so. Properly discard this product||
0170|174|R|when it is expired or no longer needed. Consult your pharmacist||
0170|175|R|or local waste disposal company.||
0170|176|B|||
0170|177|A|Information last revised August 2024.||
0170|178|A|Copyright(c) 2025 First Databank, Inc.||
0170|179|B|||
0172|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0172|002|Z|does NOT have all possible information about this product. This||
0172|003|Z|information does not assure that this product is safe, effective,||
0172|004|Z|or appropriate for you. This information is not individual||
0172|005|Z|medical advice and does not substitute for the advice of your||
0172|006|Z|health care professional. Always ask your health care||
0172|007|Z|professional for complete information about this product and your||
0172|008|Z|specific health needs.||
0172|009|B|||
0172|010|T|CODEINE/PROMETHAZINE SYRUP- ORAL||
0172|011|F|(KOE-deen/proe-METH-a-zeen)||
0172|012|B|||
0172|013|C|COMMON BRAND NAME(S): Phenergan w/ codeine||
0172|014|B|||
0172|015|W|WARNING:  This medication has a risk for abuse and addiction,||
0172|016|W|which can lead to overdose and death. This medication may also||
0172|017|W|cause severe, possibly fatal, breathing problems. To lower your||
0172|018|W|risk, your doctor should have you take the smallest dose that||
0172|019|W|works, and take it for the shortest possible time. See also How||
0172|020|W|to Use section for more information about addiction.||
0172|021|W|   The risk for severe breathing problems is higher when you||
0172|022|W|start this medication, or if you take the wrong dose or take more||
0172|023|W|of this medication than prescribed. Taking this medication with||
0172|024|W|alcohol or other drugs that can cause drowsiness or breathing||
0172|025|W|problems may cause very serious side effects, including death.||
0172|026|W|Also, other medications can affect the removal of this product||
0172|027|W|from your body, which may affect how it works. Be sure you know||
0172|028|W|how to take this product and what other drugs you should avoid||
0172|029|W|taking with it. See also Drug Interactions section. Get medical||
0172|030|W|help right away if any of these very serious side effects occur:||
0172|031|W|slow/shallow breathing, unusual lightheadedness, severe||
0172|032|W|drowsiness/dizziness, difficulty waking up.||
0172|033|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0172|034|W|or abuse. If someone accidentally swallows this drug, get medical||
0172|035|W|help right away.||
0172|036|W|   Before using this medication, women of childbearing age should||
0172|037|W|talk with their doctor(s) about the risks and benefits. Tell your||
0172|038|W|doctor if you are pregnant or think you may be pregnant. During||
0172|039|W|pregnancy, this medication is not recommended. It may slightly||
0172|040|W|increase the risk of birth defects if used during the first two||
0172|041|W|months of pregnancy. Also, using it for a long time or in high||
0172|042|W|doses near the expected delivery date may harm the unborn baby.||
0172|043|W|To lessen the risk, take the smallest effective dose for the||
0172|044|W|shortest possible time. Babies born to mothers who use this drug||
0172|045|W|for a long time may develop severe (possibly fatal) withdrawal||
0172|046|W|symptoms. Tell the doctor right away if you notice any symptoms||
0172|047|W|in your newborn baby such as crying that doesn't stop,||
0172|048|W|slow/shallow breathing, irritability, shaking, vomiting,||
0172|049|W|diarrhea, poor feeding, or difficulty gaining weight.||
0172|050|B|||
0172|051|U|USES:  This combination medication is used to treat symptoms||
0172|052|U|caused by the common cold, flu, allergies, or other breathing||
0172|053|U|illnesses (such as sinusitis, bronchitis). Promethazine is an||
0172|054|U|antihistamine that relieves watery eyes, itchy eyes/nose/throat,||
0172|055|U|runny nose, and sneezing. Codeine is an opioid cough suppressant||
0172|056|U|(antitussive) that affects a certain part of the brain, reducing||
0172|057|U|the urge to cough.||
0172|058|U|   Opioid cough suppressants should not be used by children||
0172|059|U|younger than 18 years. Children are at higher risk for serious||
0172|060|U|(even fatal) side effects, especially breathing problems. Talk||
0172|061|U|with the doctor about the risks and benefits of this medication.||
0172|062|U|   Cough-and-cold products do not cure colds. Cough due to a||
0172|063|U|common cold often does not need to be treated with medicine. Ask||
0172|064|U|your doctor or pharmacist about other ways to relieve cough and||
0172|065|U|cold symptoms, such as drinking enough fluids, using a||
0172|066|U|humidifier, or saline nose drops/spray.||
0172|067|B|||
0172|068|H|HOW TO USE:  Read the Medication Guide provided by your||
0172|069|H|pharmacist before you start taking codeine/promethazine and each||
0172|070|H|time you get a refill. If you have any questions, ask your doctor||
0172|071|H|or pharmacist.||
0172|072|H|   Take this medication by mouth with or without food as directed||
0172|073|H|by your doctor, usually every 4 to 6 hours as needed. This||
0172|074|H|medication can be taken with food if stomach upset occurs. Drink||
0172|075|H|plenty of fluids when you use this medication unless otherwise||
0172|076|H|directed by your doctor.||
0172|077|H|   Carefully measure the dose using a special measuring||
0172|078|H|device/spoon. Do not use a household spoon because you may not||
0172|079|H|get the correct dose.||
0172|080|H|   Do not increase your dose or use this product more often or||
0172|081|H|for longer than prescribed. Your condition will not improve any||
0172|082|H|faster, and your risk of side effects will increase.||
0172|083|H|   If you suddenly stop using this medication, you may have||
0172|084|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
0172|085|H|nose, nausea, sweating, muscle aches). To help prevent||
0172|086|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0172|087|H|more likely if you have used this medication for a long time||
0172|088|H|(more than a few weeks) or in high doses. Tell your doctor or||
0172|089|H|pharmacist right away if you have withdrawal.||
0172|090|H|   Though it helps many people, this medication may sometimes||
0172|091|H|cause addiction. This risk may be higher if you have a||
0172|092|H|mental/mood disorder or a substance use disorder (such as overuse||
0172|093|H|of or addiction to drugs/alcohol). Take this medication exactly||
0172|094|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0172|095|H|pharmacist for more details.||
0172|096|H|   When used for an extended time, this medication may not work||
0172|097|H|as well and may require different dosing. Talk with your doctor||
0172|098|H|if this medication stops working well.||
0172|099|H|   Tell your doctor if your cough does not get better in 5 days.||
0172|100|H|Also, tell your doctor if your condition gets worse, or if you||
0172|101|H|have a headache that doesn't go away, fever, or rash. These may||
0172|102|H|be symptoms of a serious medical problem and should be checked by||
0172|103|H|a doctor.||
0172|104|B|||
0172|105|S|SIDE EFFECTS:  See also Warning section.||
0172|106|S|   Drowsiness, dizziness, headache, lightheadedness, blurred||
0172|107|S|vision, upset stomach, nausea, constipation, or dry mouth may||
0172|108|S|occur. If any of these effects last or get worse, tell your||
0172|109|S|doctor or pharmacist promptly.||
0172|110|S|   To reduce the risk of dizziness and lightheadedness, get up||
0172|111|S|slowly when rising from a sitting or lying position.||
0172|112|S|   This medication can dry up and thicken mucus in your lungs,||
0172|113|S|making it more difficult to breathe and clear your lungs. To help||
0172|114|S|prevent this effect, drink plenty of fluids unless otherwise||
0172|115|S|directed by your doctor.||
0172|116|S|   Remember that this medication has been prescribed because your||
0172|117|S|doctor has judged that the benefit to you is greater than the||
0172|118|S|risk of side effects. Many people using this medication do not||
0172|119|S|have serious side effects.||
0172|120|S|   Tell your doctor right away if you have any serious side||
0172|121|S|effects, including: interrupted breathing during sleep (sleep||
0172|122|S|apnea), involuntary behaviors/movements (such as fixed upward||
0172|123|S|stare, neck twisting, tongue movements), mental/mood changes||
0172|124|S|(such as hallucinations, confusion), ringing in the ears, shaking||
0172|125|S|(tremors), trouble urinating, weakness, trouble swallowing.||
0172|126|S|   Get medical help right away if you have any very serious side||
0172|127|S|effects, including: nausea/vomiting that doesn't stop, easy||
0172|128|S|bruising/bleeding, slow heartbeat, severe abdominal pain,||
0172|129|S|yellowing eyes/skin, seizure.||
0172|130|S|   Codeine is changed into a strong opioid drug (morphine) in||
0172|131|S|your body. In some people, this change happens faster and more||
0172|132|S|completely than usual, which increases the risk of very serious||
0172|133|S|side effects. Get medical help right away if you notice any of||
0172|134|S|the following: slow/shallow breathing, severe||
0172|135|S|drowsiness/difficulty waking up, confusion.||
0172|136|S|   This medication may rarely cause a very serious condition||
0172|137|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0172|138|S|right away if you have any of the following symptoms: fever,||
0172|139|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
0172|140|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
0172|141|S|signs of kidney problems (such as change in the amount of urine).||
0172|142|S|   A very serious allergic reaction to this drug is rare.||
0172|143|S|However, get medical help right away if you notice any symptoms||
0172|144|S|of a serious allergic reaction, including: rash, itching/swelling||
0172|145|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0172|146|S|breathing.||
0172|147|S|   This is not a complete list of possible side effects. If you||
0172|148|S|notice other side effects not listed above, contact your doctor||
0172|149|S|or pharmacist.||
0172|150|S|   In the US -||
0172|151|S|   Call your doctor for medical advice about side effects. You||
0172|152|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0172|153|S|www.fda.gov/medwatch.||
0172|154|S|   In Canada - Call your doctor for medical advice about side||
0172|155|S|effects. You may report side effects to Health Canada at||
0172|156|S|1-866-234-2345.||
0172|157|B|||
0172|158|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0172|159|P|pharmacist if you are allergic to any of its ingredients; or to||
0172|160|P|opioid pain relievers (such as morphine); or if you have any||
0172|161|P|other allergies. This product may contain inactive ingredients,||
0172|162|P|which can cause allergic reactions or other problems. Talk to||
0172|163|P|your pharmacist for more details.||
0172|164|P|   Before using this medication, tell your doctor or pharmacist||
0172|165|P|your medical history, especially of: abdominal problems (such as||
0172|166|P|chronic constipation, ileus, pancreatitis), gallbladder disease,||
0172|167|P|adrenal gland problem (such as Addison's disease), blood/immune||
0172|168|P|system problems (such as bone marrow depression), brain disorders||
0172|169|P|(such as seizures, head injury, tumor, increased intracranial||
0172|170|P|pressure), breathing problems (such as asthma, emphysema, sleep||
0172|171|P|apnea), diabetes, glaucoma, heart problems (such as angina,||
0172|172|P|irregular heartbeat), high blood pressure, kidney disease, liver||
0172|173|P|disease, mental/mood problems (such as depression, psychosis),||
0172|174|P|obesity, a certain spinal problem (kyphoscoliosis),||
0172|175|P|stomach/intestinal problems (such as ulcers, blockage), thyroid||
0172|176|P|disease, trouble urinating (such as due to enlarged prostate or||
0172|177|P|urethral stricture), personal or family history of a substance||
0172|178|P|use disorder (such as overuse of or addiction to drugs/alcohol).||
0172|179|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0172|180|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0172|181|P|machinery, or do anything that needs alertness until you can do||
0172|182|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0172|183|P|are using marijuana (cannabis).||
0172|184|P|   This medication may make you more sensitive to the sun. Limit||
0172|185|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0172|186|P|sunscreen and wear protective clothing when outdoors. Tell your||
0172|187|P|doctor right away if you get sunburned or have skin||
0172|188|P|blisters/redness.||
0172|189|P|   This medication may contain sugar and/or alcohol. Caution is||
0172|190|P|advised if you have diabetes, alcohol dependence, or liver||
0172|191|P|disease. Ask your doctor or pharmacist about using this product||
0172|192|P|safely.||
0172|193|P|   Older adults may be more sensitive to the side effects of this||
0172|194|P|drug, especially confusion, dizziness, drowsiness, constipation,||
0172|195|P|trouble urinating, and slow/shallow breathing. Confusion,||
0172|196|P|dizziness, and drowsiness can increase the risk of falling.||
0172|197|P|   Tell your doctor if you are pregnant or think you may be||
0172|198|P|pregnant. During pregnancy, this product is not recommended. It||
0172|199|P|may harm an unborn baby. Talk to your doctor about the risks and||
0172|200|P|benefits of this medication. See also Warning section.||
0172|201|P|   This product passes into breast milk and may have undesirable||
0172|202|P|effects on a nursing infant (such as unusual sleepiness,||
0172|203|P|difficulty feeding, trouble breathing, or unusual limpness).||
0172|204|P|Consult your doctor before breastfeeding.||
0172|205|B|||
0172|206|I|DRUG INTERACTIONS:  See also Warning section.||
0172|207|I|   Drug interactions may change how your medications work or||
0172|208|I|increase your risk for serious side effects. This document does||
0172|209|I|not contain all possible drug interactions. Keep a list of all||
0172|210|I|the products you use (including prescription/nonprescription||
0172|211|I|drugs and herbal products) and share it with your doctor and||
0172|212|I|pharmacist. Do not start, stop, or change the dosage of any||
0172|213|I|medicines without your doctor's approval.||
0172|214|I|   Some products that may interact with this drug include:||
0172|215|I|antihistamines applied to the skin (such as diphenhydramine||
0172|216|I|cream, ointment, spray), cimetidine, metoclopramide, naltrexone,||
0172|217|I|samidorphan.||
0172|218|I|   The risk of serious side effects (such as slow/shallow||
0172|219|I|breathing, severe drowsiness/dizziness) may be increased if this||
0172|220|I|medication is taken with other products that may also cause||
0172|221|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0172|222|I|if you are taking other products such as other opioid pain or||
0172|223|I|cough relievers (such as morphine, hydrocodone), alcohol,||
0172|224|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0172|225|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0172|226|I|carisoprodol, cyclobenzaprine), or other antihistamines (such as||
0172|227|I|cetirizine, diphenhydramine).||
0172|228|I|   Check the labels on all your medicines (such as allergy or||
0172|229|I|cough-and-cold products) because they may contain ingredients||
0172|230|I|that cause drowsiness. Ask your pharmacist about using those||
0172|231|I|products safely.||
0172|232|I|   Other medications can affect the removal of||
0172|233|I|codeine/promethazine from your body, which may affect how||
0172|234|I|codeine/promethazine works. Examples include azole antifungals||
0172|235|I|(such as ketoconazole), bupropion, fluoxetine, macrolide||
0172|236|I|antibiotics (such as erythromycin), paroxetine, quinidine,||
0172|237|I|rifamycins (such as rifabutin, rifampin), ritonavir, certain||
0172|238|I|drugs used to treat seizures (such as carbamazepine, phenytoin),||
0172|239|I|among others.||
0172|240|I|   This medication may interfere with certain lab tests (such as||
0172|241|I|some pregnancy tests, blood sugar tests, amylase/lipase levels),||
0172|242|I|possibly causing false test results. Make sure lab personnel and||
0172|243|I|all your doctors know you use this drug.||
0172|244|B|||
0172|245|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0172|246|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0172|247|O|poison control center right away. US residents can call||
0172|248|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0172|249|O|Symptoms of overdose may include: confusion, cold/clammy skin,||
0172|250|O|fast/slow/irregular heartbeat, slow/shallow breathing, seizures,||
0172|251|O|fainting, coma.||
0172|252|B|||
0172|253|N|NOTES:  Do not share this medication with others. Sharing it is||
0172|254|N|against the law.||
0172|255|N|   Do not take this medication for several days before allergy||
0172|256|N|testing because test results can be affected.||
0172|257|B|||
0172|258|D|MISSED DOSE:  If you are prescribed this medication on a regular||
0172|259|D|schedule and miss a dose, take it as soon as you remember. If it||
0172|260|D|is near the time of the next dose, skip the missed dose. Take||
0172|261|D|your next dose at the regular time. Do not double the dose to||
0172|262|D|catch up.||
0172|263|B|||
0172|264|R|STORAGE:  Store at room temperature away from light and moisture.||
0172|265|R|Do not store in the bathroom. Do not freeze. Keep all medications||
0172|266|R|away from children and pets.||
0172|267|R|   Do not flush medications down the toilet or pour them into a||
0172|268|R|drain unless instructed to do so. Properly discard this product||
0172|269|R|when it is expired or no longer needed. Consult your pharmacist||
0172|270|R|or local waste disposal company.||
0172|271|B|||
0172|272|A|Information last revised August 2025.||
0172|273|A|Copyright(c) 2025 First Databank, Inc.||
0172|274|B|||
0173|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0173|002|Z|does NOT have all possible information about this product. This||
0173|003|Z|information does not assure that this product is safe, effective,||
0173|004|Z|or appropriate for you. This information is not individual||
0173|005|Z|medical advice and does not substitute for the advice of your||
0173|006|Z|health care professional. Always ask your health care||
0173|007|Z|professional for complete information about this product and your||
0173|008|Z|specific health needs.||
0173|009|B|||
0173|010|T|NAPHAZOLINE/PHENIRAMINE - OPHTHALMIC||
0173|011|F|(naf-AZ-oh-leen/fen-IR-a-meen)||
0173|012|B|||
0173|013|C|COMMON BRAND NAME(S): Naphcon-A, Opcon-A||
0173|014|B|||
0173|015|U|USES:  This medication is used to temporarily relieve eye||
0173|016|U|redness, puffiness, itching, and watering that commonly occur||
0173|017|U|with allergies. Naphazoline is a decongestant. It belongs to a||
0173|018|U|class of drugs known as sympathomimetic amines. It works by||
0173|019|U|temporarily narrowing the blood vessels in the eye. Pheniramine||
0173|020|U|is an antihistamine. It works by blocking certain natural||
0173|021|U|substances (histamines) that cause allergic symptoms.||
0173|022|U|   Do not use this medication to treat redness and irritation||
0173|023|U|from wearing contact lenses.||
0173|024|B|||
0173|025|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0173|026|H|directed by your doctor, usually up to 4 times a day as needed.||
0173|027|H|   To apply eye drops, wash your hands first. To avoid||
0173|028|H|contamination, do not touch the dropper tip or let it touch your||
0173|029|H|eye or any other surface.||
0173|030|H|   Remove contact lenses before applying the eye drops. Wait at||
0173|031|H|least 10 minutes after using this medication before inserting||
0173|032|H|contact lenses. If your eyes are red, ask your doctor whether you||
0173|033|H|should wear your contact lenses.||
0173|034|H|   Before using, check this product for cloudiness or||
0173|035|H|discoloration. If either is present, do not use the liquid.||
0173|036|H|   Tilt your head back, look upward, and pull down the lower||
0173|037|H|eyelid to make a pouch. Hold the dropper directly over the eye||
0173|038|H|and place 1 drop into the pouch. Look downward and gently close||
0173|039|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0173|040|H|the eye near the nose and apply gentle pressure. This will||
0173|041|H|prevent the medication from draining away from the eye. Try not||
0173|042|H|to blink and do not rub the eye. Repeat these steps if your dose||
0173|043|H|is for more than 1 drop and for the other eye if so directed.||
0173|044|H|   Do not rinse the dropper. Replace the dropper cap tightly||
0173|045|H|after each use.||
0173|046|H|   If you are using another kind of eye medication (such as drops||
0173|047|H|or ointments), wait at least 5 minutes before applying other||
0173|048|H|medications. Use eye drops before eye ointments to allow the||
0173|049|H|drops to enter the eye.||
0173|050|H|   Wait several minutes for your vision to clear before driving||
0173|051|H|or operating machinery.||
0173|052|H|   Overuse of this type of medication may result in increased eye||
0173|053|H|redness (rebound effect when drug wears off). If this occurs,||
0173|054|H|tell your doctor. Do not use this medication for longer than 3 to||
0173|055|H|4 days at a time. If your condition lasts or gets worse after 72||
0173|056|H|hours, or if you think you may have a serious medical problem,||
0173|057|H|stop using this medication and get medical help right away.||
0173|058|B|||
0173|059|S|SIDE EFFECTS:  Stinging/redness in the eye, widened pupils, or||
0173|060|S|blurred vision may occur. If any of these effects last or get||
0173|061|S|worse, tell your doctor or pharmacist promptly.||
0173|062|S|   If your doctor has directed you to use this medication,||
0173|063|S|remember that your doctor has judged that the benefit to you is||
0173|064|S|greater than the risk of side effects. Many people using this||
0173|065|S|medication do not have serious side effects.||
0173|066|S|   Tell your doctor right away if you have any serious side||
0173|067|S|effects, including: eye pain, worsening redness/itching/swelling||
0173|068|S|in or around the eyes, vision problems, shakiness (tremor),||
0173|069|S|fast/pounding/ irregular heartbeat, headache, sweating, weakness,||
0173|070|S|nervousness.||
0173|071|S|   A very serious allergic reaction to this drug is rare.||
0173|072|S|However, get medical help right away if you notice any symptoms||
0173|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0173|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0173|075|S|breathing.||
0173|076|S|   This is not a complete list of possible side effects. If you||
0173|077|S|notice other effects not listed above, contact your doctor or||
0173|078|S|pharmacist.||
0173|079|S|   In the US -||
0173|080|S|   Call your doctor for medical advice about side effects. You||
0173|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0173|082|S|www.fda.gov/medwatch.||
0173|083|S|   In Canada - Call your doctor for medical advice about side||
0173|084|S|effects. You may report side effects to Health Canada at||
0173|085|S|1-866-234-2345.||
0173|086|B|||
0173|087|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0173|088|P|pharmacist if you are allergic to naphazoline or to pheniramine;||
0173|089|P|or if you have any other allergies. This product may contain||
0173|090|P|inactive ingredients (such as preservatives like benzalkonium||
0173|091|P|chloride), which can cause allergic reactions or other problems.||
0173|092|P|Talk to your pharmacist for more details.||
0173|093|P|   If you have any of the following health problems, consult your||
0173|094|P|doctor or pharmacist before using this product: diabetes,||
0173|095|P|glaucoma, heart problems (such as heart attack, chest pain), high||
0173|096|P|blood pressure, eye infection/injury, overactive thyroid||
0173|097|P|(hyperthyroidism), difficulty urinating.||
0173|098|P|   After you apply this drug, your vision may become temporarily||
0173|099|P|blurred. Do not drive, use machinery, or do anything that needs||
0173|100|P|clear vision until you can do it safely.||
0173|101|P|   During pregnancy, this medication should be used only when||
0173|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0173|103|P|   It is unknown if this drug passes into breast milk. Consult||
0173|104|P|your doctor before breastfeeding.||
0173|105|B|||
0173|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0173|107|I|medications work or increase your risk for serious side effects.||
0173|108|I|This document does not contain all possible drug interactions.||
0173|109|I|Keep a list of all the products you use (including||
0173|110|I|prescription/nonprescription drugs and herbal products) and share||
0173|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0173|112|I|the dosage of any medicines without your doctor's approval.||
0173|113|B|||
0173|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0173|115|O|has overdosed and has serious symptoms such as passing out or||
0173|116|O|trouble breathing, call 911. Otherwise, call a poison control||
0173|117|O|center right away. US residents can call 1-800-222-1222. Canada||
0173|118|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0173|119|O|include: drowsiness, decreased body temperature, slow/shallow||
0173|120|O|breathing.||
0173|121|B|||
0173|122|N|NOTES:  Avoid allergens that may be the cause of your symptoms.||
0173|123|N|Some common causes of allergies include pollen, grasses, weeds,||
0173|124|N|dust mites, and pet dander.||
0173|125|B|||
0173|126|D|MISSED DOSE:  If your doctor has directed you to use this||
0173|127|D|medication on a regular schedule and you miss a dose, use it as||
0173|128|D|soon as you remember. If it is near the time of the next dose,||
0173|129|D|skip the missed dose. Use your next dose at the regular time. Do||
0173|130|D|not double the dose to catch up.||
0173|131|B|||
0173|132|R|STORAGE:  Store at room temperature away from light. Keep all||
0173|133|R|medications away from children and pets.||
0173|134|R|   Do not flush medications down the toilet or pour them into a||
0173|135|R|drain unless instructed to do so. Properly discard this product||
0173|136|R|when it is expired or no longer needed. Consult your pharmacist||
0173|137|R|or local waste disposal company.||
0173|138|B|||
0173|139|A|Information last revised November 2024.||
0173|140|A|Copyright(c) 2025 First Databank, Inc.||
0173|141|B|||
0175|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0175|002|Z|does NOT have all possible information about this product. This||
0175|003|Z|information does not assure that this product is safe, effective,||
0175|004|Z|or appropriate for you. This information is not individual||
0175|005|Z|medical advice and does not substitute for the advice of your||
0175|006|Z|health care professional. Always ask your health care||
0175|007|Z|professional for complete information about this product and your||
0175|008|Z|specific health needs.||
0175|009|B|||
0175|010|T|METYRAPONE - ORAL||
0175|011|F|(me-TIR-a-pone)||
0175|012|B|||
0175|013|C|COMMON BRAND NAME(S): Metopirone||
0175|014|B|||
0175|015|U|USES:  Metyrapone is used to test if your pituitary gland is||
0175|016|U|sending the proper signals to your adrenal glands. Normally the||
0175|017|U|pituitary gland in your brain sends signals to your adrenal||
0175|018|U|glands to make a natural substance called cortisol. Cortisol is||
0175|019|U|important for keeping your body functioning well and for good||
0175|020|U|health.||
0175|021|B|||
0175|022|H|HOW TO USE:  Take this medication by mouth with milk or a snack||
0175|023|H|as directed by your doctor. The dosage is based on your weight.||
0175|024|H|   If you are directed to use the single-dose test, take your||
0175|025|H|dose of metyrapone at midnight. Early the next morning, your||
0175|026|H|doctor will take a blood sample from you.||
0175|027|H|   If you are directed to use the multiple-dose test, take this||
0175|028|H|medication exactly at the times recommended by your doctor. For||
0175|029|H|one day, several days before taking this medication, you will||
0175|030|H|need to collect all your urine for a 24-hour period for testing,||
0175|031|H|and then again on the day after you take this medication.||
0175|032|H|   It is important to take this medication as directed to assure||
0175|033|H|proper test results.||
0175|034|B|||
0175|035|S|SIDE EFFECTS:  Nausea, upset stomach, headache, dizziness, or||
0175|036|S|drowsiness may occur. If any of these effects last or get worse,||
0175|037|S|tell your doctor promptly.||
0175|038|S|   Remember that your doctor has prescribed this medication||
0175|039|S|because the benefit to you is greater than the risk of side||
0175|040|S|effects. Many people using this medication do not have serious||
0175|041|S|side effects.||
0175|042|S|   A very serious allergic reaction to this drug is rare.||
0175|043|S|However, get medical help right away if you notice any symptoms||
0175|044|S|of a serious allergic reaction, including: rash, itching/swelling||
0175|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0175|046|S|breathing.||
0175|047|S|   This is not a complete list of possible side effects. If you||
0175|048|S|notice other effects not listed above, contact your doctor or||
0175|049|S|pharmacist.||
0175|050|S|   In the US -||
0175|051|S|   Call your doctor for medical advice about side effects. You||
0175|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0175|053|S|www.fda.gov/medwatch.||
0175|054|S|   In Canada - Call your doctor for medical advice about side||
0175|055|S|effects. You may report side effects to Health Canada at||
0175|056|S|1-866-234-2345.||
0175|057|B|||
0175|058|P|PRECAUTIONS:  Before taking metyrapone, tell your doctor or||
0175|059|P|pharmacist if you are allergic to it; or if you have any other||
0175|060|P|allergies. This product may contain inactive ingredients, which||
0175|061|P|can cause allergic reactions or other problems. Talk to your||
0175|062|P|pharmacist for more details.||
0175|063|P|   Before using this medication, tell your doctor or pharmacist||
0175|064|P|your medical history, especially of: decreased adrenal gland||
0175|065|P|function (primary adrenal insufficiency), thyroid problems.||
0175|066|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0175|067|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0175|068|P|machinery, or do anything that needs alertness until you can do||
0175|069|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0175|070|P|are using marijuana (cannabis).||
0175|071|P|   During pregnancy, this medication should be used only when||
0175|072|P|clearly needed. Discuss the risks and benefits with your doctor.||
0175|073|P|A below-normal response to this medication may occur in pregnant||
0175|074|P|women.||
0175|075|P|   It is unknown if this medication passes into breast milk.||
0175|076|P|Consult your doctor before breastfeeding.||
0175|077|B|||
0175|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0175|079|I|medications work or increase your risk for serious side effects.||
0175|080|I|This document does not contain all possible drug interactions.||
0175|081|I|Keep a list of all the products you use (including||
0175|082|I|prescription/nonprescription drugs and herbal products) and share||
0175|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
0175|084|I|the dosage of any medicines without your doctor's approval.||
0175|085|I|   Some products that may interact with this drug include:||
0175|086|I|acetaminophen, cyproheptadine, estrogens, hydantoins (such as||
0175|087|I|phenytoin).||
0175|088|I|   If you are taking corticosteroids (such as hydrocortisone,||
0175|089|I|prednisone), these medications must be stopped before and during||
0175|090|I|metyrapone testing. Consult your doctor for more details about||
0175|091|I|how to do so safely.||
0175|092|B|||
0175|093|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0175|094|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0175|095|O|poison control center right away. US residents can call||
0175|096|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0175|097|O|Symptoms of overdose may include: fast/irregular heartbeat,||
0175|098|O|severe dizziness, anxiety, confusion, weakness, vomiting, stomach||
0175|099|O|pain.||
0175|100|B|||
0175|101|N|NOTES:  Do not share this medication with others.||
0175|102|N|   Blood or urine tests will be done to test your response to||
0175|103|N|this medication. Consult your doctor for more details.||
0175|104|B|||
0175|105|D|MISSED DOSE:  If you miss a dose, contact your doctor right away||
0175|106|D|for advice and instructions.||
0175|107|B|||
0175|108|R|STORAGE:  Store at room temperature away from moisture, light,||
0175|109|R|and heat. Do not store in the bathroom. Keep all medications away||
0175|110|R|from children and pets.||
0175|111|R|   Do not flush medications down the toilet or pour them into a||
0175|112|R|drain unless instructed to do so. Properly discard this product||
0175|113|R|when it is expired or no longer needed. Consult your pharmacist||
0175|114|R|or local waste disposal company.||
0175|115|B|||
0175|116|A|Information last revised May 2024.||
0175|117|A|Copyright(c) 2025 First Databank, Inc.||
0175|118|B|||
0178|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0178|002|Z|does NOT have all possible information about this product. This||
0178|003|Z|information does not assure that this product is safe, effective,||
0178|004|Z|or appropriate for you. This information is not individual||
0178|005|Z|medical advice and does not substitute for the advice of your||
0178|006|Z|health care professional. Always ask your health care||
0178|007|Z|professional for complete information about this product and your||
0178|008|Z|specific health needs.||
0178|009|B|||
0178|010|T|FAT EMULSION - INJECTION||
0178|011|B|||
0178|012|C|COMMON BRAND NAME(S): Clinolipid, Intralipid, Liposyn||
0178|013|B|||
0178|014|U|USES:  This product is used to provide calories to patients who||
0178|015|U|are getting their nutrition through an injection into the vein.||
0178|016|U|Calories are needed to provide the body with energy so that the||
0178|017|U|body can work properly. This product is also used to provide a||
0178|018|U|certain nutrient (essential fatty acids) to people who do not||
0178|019|U|have enough of it. This product helps to prevent or reverse the||
0178|020|U|signs of this deficiency (such as scaly skin, poor growth, poor||
0178|021|U|wound healing).||
0178|022|B|||
0178|023|H|HOW TO USE:  This product is given by injection into a vein as||
0178|024|H|directed by your doctor. Before using, check this product for||
0178|025|H|particles, oil, or discoloration. If you see any of these things,||
0178|026|H|do not use the liquid. Learn all preparation and usage||
0178|027|H|instructions in the product package. If any of the information is||
0178|028|H|unclear, consult your doctor or pharmacist.||
0178|029|H|   Except for heparin, do not add any medication/minerals to the||
0178|030|H|product container.||
0178|031|H|   The dosage is based on your medical condition, age, weight,||
0178|032|H|and response to treatment.||
0178|033|B|||
0178|034|S|SIDE EFFECTS:  Headache, flushing, nausea, vomiting, or sweating||
0178|035|S|may occur. If any of these effects last or get worse, tell your||
0178|036|S|doctor or pharmacist promptly.||
0178|037|S|   Remember that this medication has been prescribed because your||
0178|038|S|doctor has judged that the benefit to you is greater than the||
0178|039|S|risk of side effects. Many people using this medication do not||
0178|040|S|have serious side effects.||
0178|041|S|   Tell your doctor right away if you have any serious side||
0178|042|S|effects, including: signs of infection (such as sore throat that||
0178|043|S|doesn't go away, fever, chills), pain/swelling/redness at||
0178|044|S|injection site, pain/swelling/redness of arms/legs, bluish skin,||
0178|045|S|sudden weight gain, shortness of breath, back/chest pain,||
0178|046|S|mental/mood changes, bone pain, muscle weakness, easy||
0178|047|S|bruising/bleeding, signs of liver disease (such as||
0178|048|S|nausea/vomiting that doesn't stop, loss of appetite,||
0178|049|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0178|050|S|   This product has rarely caused serious (rarely fatal)||
0178|051|S|breathing problems in newborns and infants when it is given too||
0178|052|S|rapidly. The risk may be higher in premature or low-birth-weight||
0178|053|S|infants. Infants/newborns must be monitored closely while||
0178|054|S|receiving this product. If you notice the following unlikely but||
0178|055|S|serious side effect in infants/newborns, get medical help right||
0178|056|S|away: rapid/shallow breathing.||
0178|057|S|   A very serious allergic reaction to this drug is rare.||
0178|058|S|However, get medical help right away if you notice any symptoms||
0178|059|S|of a serious allergic reaction, including: rash, itching/swelling||
0178|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0178|061|S|breathing.||
0178|062|S|   This is not a complete list of possible side effects. If you||
0178|063|S|notice other effects not listed above, contact your doctor or||
0178|064|S|pharmacist.||
0178|065|S|   In the US -||
0178|066|S|   Call your doctor for medical advice about side effects. You||
0178|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0178|068|S|www.fda.gov/medwatch.||
0178|069|S|   In Canada - Call your doctor for medical advice about side||
0178|070|S|effects. You may report side effects to Health Canada at||
0178|071|S|1-866-234-2345.||
0178|072|B|||
0178|073|P|PRECAUTIONS:  Before receiving the fat emulsion, tell your doctor||
0178|074|P|or pharmacist if you are allergic to it; or to eggs, safflower||
0178|075|P|oil, or soy/peanut found in some brands; or if you have any other||
0178|076|P|allergies. This product may contain inactive ingredients, which||
0178|077|P|can cause allergic reactions or other problems. Talk to your||
0178|078|P|pharmacist for more details.||
0178|079|P|   Before using this medication, tell your doctor or pharmacist||
0178|080|P|your medical history, especially of: high fat (lipid) levels in||
0178|081|P|the blood, liver disease, kidney disease, lung disease, anemia,||
0178|082|P|blood clotting disorder.||
0178|083|P|   Before having surgery, tell your doctor or dentist about all||
0178|084|P|the products you use (including prescription drugs,||
0178|085|P|nonprescription drugs, and herbal products).||
0178|086|P|   Older adults may be at greater risk for bone pain and||
0178|087|P|mental/mood changes while using this drug.||
0178|088|P|   Children may be at greater risk for liver disease while using||
0178|089|P|this drug. Newborns and infants may also be at greater risk for||
0178|090|P|bone pain and mental/mood changes while using this drug.||
0178|091|P|   During pregnancy, this medication should be used only when||
0178|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
0178|093|P|   It is unknown if this drug passes into breast milk. Consult||
0178|094|P|your doctor before breastfeeding.||
0178|095|B|||
0178|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0178|097|I|medications work or increase your risk for serious side effects.||
0178|098|I|This document does not contain all possible drug interactions.||
0178|099|I|Keep a list of all the products you use (including||
0178|100|I|prescription/nonprescription drugs and herbal products) and share||
0178|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0178|102|I|the dosage of any medicines without your doctor's approval.||
0178|103|I|   This medication may interfere with certain lab tests possibly||
0178|104|I|causing false test results. Make sure lab personnel and all your||
0178|105|I|doctors know you use this drug.||
0178|106|B|||
0178|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0178|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0178|109|O|poison control center right away. US residents can call||
0178|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0178|111|B|||
0178|112|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0178|113|N|liver/kidney function, lipid panel) should be done before you||
0178|114|N|start using this medication and while you are using it. Keep all||
0178|115|N|medical and lab appointments. Consult your doctor for more||
0178|116|N|details.||
0178|117|B|||
0178|118|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0178|119|D|If it is near the time of the next dose, skip the missed dose.||
0178|120|D|Use your next dose at the regular time. Do not double the dose to||
0178|121|D|catch up.||
0178|122|B|||
0178|123|R|STORAGE:  Store the unopened product at room temperature away||
0178|124|R|from light. Do not freeze. Keep the medication in the original||
0178|125|R|pouch until ready to use. Keep all medications away from children||
0178|126|R|and pets.||
0178|127|R|   Do not flush medications down the toilet or pour them into a||
0178|128|R|drain unless instructed to do so. Properly discard this product||
0178|129|R|when it is expired or no longer needed. Consult your pharmacist||
0178|130|R|or local waste disposal company.||
0178|131|B|||
0178|132|A|Information last revised June 2025.||
0178|133|A|Copyright(c) 2025 First Databank, Inc.||
0178|134|B|||
0179|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0179|002|Z|does NOT have all possible information about this product. This||
0179|003|Z|information does not assure that this product is safe, effective,||
0179|004|Z|or appropriate for you. This information is not individual||
0179|005|Z|medical advice and does not substitute for the advice of your||
0179|006|Z|health care professional. Always ask your health care||
0179|007|Z|professional for complete information about this product and your||
0179|008|Z|specific health needs.||
0179|009|B|||
0179|010|T|KETOCONAZOLE SHAMPOO - TOPICAL||
0179|011|F|(KEE-toe-KON-a-zole)||
0179|012|B|||
0179|013|C|COMMON BRAND NAME(S): Nizoral||
0179|014|B|||
0179|015|U|USES:  This medication is used to control dandruff. Use of this||
0179|016|U|medication may help to relieve the flaking, scaling and itching||
0179|017|U|associated with dandruff. Ketoconazole is an azole antifungal||
0179|018|U|that works by preventing the growth of fungus.||
0179|019|U|   Ketoconazole 2% shampoo is also used to treat a skin condition||
0179|020|U|known as pityriasis (tinea versicolor), a fungal infection that||
0179|021|U|causes a lightening or darkening of the skin of the neck, chest,||
0179|022|U|arms, or legs.||
0179|023|B|||
0179|024|H|HOW TO USE:  Wet hair and scalp completely with water. Apply||
0179|025|H|enough shampoo to produce enough lather to clean hair and scalp.||
0179|026|H|Massage gently over entire scalp. Rinse hair with warm water.||
0179|027|H|Repeat this process if directed to do so by your doctor. Dry hair||
0179|028|H|thoroughly after the final rinse.||
0179|029|H|   If using the over-the-counter strength of the shampoo (1%),||
0179|030|H|apply the shampoo, lather, and rinse thoroughly. Repeat this||
0179|031|H|process. Dry hair thoroughly after the second rinse.||
0179|032|H|   If treating skin other than the scalp, wet the skin and apply||
0179|033|H|the shampoo to affected area and the surrounding healthy skin.||
0179|034|H|Lather and leave in place for 5 minutes, then rinse off with||
0179|035|H|water.||
0179|036|H|   The dosage, number of applications, and the length of||
0179|037|H|treatment depends on the strength of the shampoo (2% or 1%) and||
0179|038|H|the condition being treated. Carefully follow your doctor's||
0179|039|H|instructions or the package directions.||
0179|040|H|   Avoid contact with the eyes. If the shampoo gets into the||
0179|041|H|eyes, rinse thoroughly with water.||
0179|042|H|   Do not begin using the shampoo if your scalp/skin is broken or||
0179|043|H|swollen.||
0179|044|H|   Tell your doctor if your condition lasts after 2 to 4 weeks of||
0179|045|H|treatment or gets worse at any time.||
0179|046|B|||
0179|047|S|SIDE EFFECTS:  Abnormal hair texture, oiliness/dryness of the||
0179|048|S|hair and scalp, or discoloration, irritation, or pimple-like||
0179|049|S|bumps on the scalp may occur. If any of these effects last or get||
0179|050|S|worse, tell your doctor or pharmacist promptly.||
0179|051|S|   If your doctor has directed you to use this medication,||
0179|052|S|remember that your doctor has judged that the benefit to you is||
0179|053|S|greater than the risk of side effects. Many people using this||
0179|054|S|medication do not have serious side effects.||
0179|055|S|   Tell your doctor right away if you have any serious side||
0179|056|S|effects, including: hair loss.||
0179|057|S|   A very serious allergic reaction to this drug is rare.||
0179|058|S|However, get medical help right away if you notice any symptoms||
0179|059|S|of a serious allergic reaction, including: rash, itching/swelling||
0179|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0179|061|S|breathing.||
0179|062|S|   This is not a complete list of possible side effects. If you||
0179|063|S|notice other effects not listed above, contact your doctor or||
0179|064|S|pharmacist.||
0179|065|S|   In the US -||
0179|066|S|   Call your doctor for medical advice about side effects. You||
0179|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0179|068|S|www.fda.gov/medwatch.||
0179|069|S|   In Canada - Call your doctor for medical advice about side||
0179|070|S|effects. You may report side effects to Health Canada at||
0179|071|S|1-866-234-2345.||
0179|072|B|||
0179|073|P|PRECAUTIONS:  Before using ketoconazole, tell your doctor or||
0179|074|P|pharmacist if you are allergic to it; or to other azole||
0179|075|P|antifungals such as clotrimazole, econazole, or miconazole; or if||
0179|076|P|you have any other allergies. This product may contain inactive||
0179|077|P|ingredients, which can cause allergic reactions or other||
0179|078|P|problems. Talk to your pharmacist for more details.||
0179|079|P|   Before using this medication, tell your doctor or pharmacist||
0179|080|P|your medical history.||
0179|081|P|   This medication should be used only if clearly needed during||
0179|082|P|pregnancy. Discuss the risks and benefits with your doctor.||
0179|083|P|   It is unknown if this drug passes into breast milk. Consult||
0179|084|P|your doctor before breastfeeding.||
0179|085|B|||
0179|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0179|087|I|medications work or increase your risk for serious side effects.||
0179|088|I|This document does not contain all possible drug interactions.||
0179|089|I|Keep a list of all the products you use (including||
0179|090|I|prescription/nonprescription drugs and herbal products) and share||
0179|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
0179|092|I|the dosage of any medicines without your doctor's approval.||
0179|093|B|||
0179|094|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0179|095|O|has overdosed and has serious symptoms such as passing out or||
0179|096|O|trouble breathing, call 911. Otherwise, call a poison control||
0179|097|O|center right away. US residents can call 1-800-222-1222. Canada||
0179|098|O|residents can call 1-844-764-7669.||
0179|099|B|||
0179|100|N|NOTES:  This shampoo may remove the curl from a permanent wave in||
0179|101|N|the hair.||
0179|102|N|   When treating pityriasis, this medication may not cause an||
0179|103|N|immediate return to normal skin color. It may take several months||
0179|104|N|after treatment is completed for your natural skin color to||
0179|105|N|return.||
0179|106|B|||
0179|107|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0179|108|D|If it is near the time of the next dose, skip the missed dose.||
0179|109|D|Use your next dose at the regular time. Do not double the dose to||
0179|110|D|catch up.||
0179|111|B|||
0179|112|R|STORAGE:  Different brands/strengths of this medication may have||
0179|113|R|different storage requirements. Read the package labeling or ask||
0179|114|R|your pharmacist for the storage requirements for the product you||
0179|115|R|are using. Keep all medications away from children and pets.||
0179|116|R|   Do not flush medications down the toilet or pour them into a||
0179|117|R|drain unless instructed to do so. Properly discard this product||
0179|118|R|when it is expired or no longer needed. Consult your pharmacist||
0179|119|R|or local waste disposal company.||
0179|120|B|||
0179|121|A|Information last revised May 2024.||
0179|122|A|Copyright(c) 2025 First Databank, Inc.||
0179|123|B|||
0181|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0181|002|Z|does NOT have all possible information about this product. This||
0181|003|Z|information does not assure that this product is safe, effective,||
0181|004|Z|or appropriate for you. This information is not individual||
0181|005|Z|medical advice and does not substitute for the advice of your||
0181|006|Z|health care professional. Always ask your health care||
0181|007|Z|professional for complete information about this product and your||
0181|008|Z|specific health needs.||
0181|009|B|||
0181|010|T|BENZOYL PEROXIDE - TOPICAL||
0181|011|F|(BEN-zoe-il per-OX-ide)||
0181|012|B|||
0181|013|C|COMMON BRAND NAME(S): Benoxyl, Benzac AC, Benzac W, Benzagel,||
0181|014|C|Brevoxyl, Desquam, Epsolay, Fostex, Lavoclen-4, Lavoclen-8,||
0181|015|C|Neobenz Micro, Persa-Gel, Triaz, Vanoxide, Zoderm||
0181|016|B|||
0181|017|U|USES:  Benzoyl peroxide products are usually used to treat mild||
0181|018|U|to moderate acne. When used to treat acne, benzoyl peroxide works||
0181|019|U|by reducing the amount of acne-causing bacteria and by causing||
0181|020|U|the skin to dry and peel. Some brands are used to treat a certain||
0181|021|U|skin condition called rosacea. Benzoyl peroxide may help to||
0181|022|U|decrease symptoms caused by rosacea, such as pimples and bumps on||
0181|023|U|the face.||
0181|024|U|   Check the ingredients on the label even if you have used the||
0181|025|U|product before. The manufacturer may have changed the||
0181|026|U|ingredients. Also, products with similar names may contain||
0181|027|U|different ingredients meant for different purposes. Taking the||
0181|028|U|wrong product could harm you.||
0181|029|B|||
0181|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0181|031|H|from your pharmacist before you start using this product and each||
0181|032|H|time you get a refill. If you have any questions, ask your doctor||
0181|033|H|or pharmacist.||
0181|034|H|   Before using this product to treat acne for the first time,||
0181|035|H|check if you are allergic to it. To check, put a small amount on||
0181|036|H|one or two small areas of acne for three days. If you have an||
0181|037|H|allergic reaction, stop using this product and get medical help||
0181|038|H|right away (see the symptoms of an allergic reaction in the Side||
0181|039|H|Effects section). If you don't have an allergic reaction, you can||
0181|040|H|use the product.||
0181|041|H|   There are many benzoyl peroxide products available. Many can||
0181|042|H|be purchased without a prescription. Some products (such as||
0181|043|H|creams, cleansers, foam, or lotions) may require a prescription.||
0181|044|H|Consult your doctor or pharmacist on the choice of the product||
0181|045|H|that is best for you. If you are using the over-the-counter||
0181|046|H|product to self-treat, read and follow all directions on the||
0181|047|H|product package before using this medication. If you have any||
0181|048|H|questions, consult your pharmacist. If your doctor has prescribed||
0181|049|H|this medication, use it as directed.||
0181|050|H|   Some products require shaking before use. Check your product||
0181|051|H|package to see if your form of this medication needs to be||
0181|052|H|shaken.||
0181|053|H|   If you are using this medication to treat acne, apply benzoyl||
0181|054|H|peroxide to the areas of your skin affected by acne. If you are||
0181|055|H|using this medication to treat rosacea, apply benzoyl peroxide to||
0181|056|H|your face. Avoid getting this medication into your eyes, inside||
0181|057|H|your nose or mouth, on the lips, or on any areas of broken skin||
0181|058|H|since it may cause irritation. If this occurs, flush the area||
0181|059|H|with plenty of water. Wash your hands after applying this||
0181|060|H|product. Benzoyl peroxide may bleach hair or fabrics. Use||
0181|061|H|carefully, and avoid contact with hair, clothing, and||
0181|062|H|furnishings.||
0181|063|H|   If using cleansers containing benzoyl peroxide, wet the||
0181|064|H|affected area. Gently rub the cleanser into the skin for 10-20||
0181|065|H|seconds. Work into a full lather and rinse thoroughly and then||
0181|066|H|pat dry. If too much drying occurs, you may need to rinse the||
0181|067|H|cleanser off sooner or use it less often. Consult your doctor or||
0181|068|H|pharmacist for further details.||
0181|069|H|   If you are using the liquid wash, cleansing pad, or cleanser||
0181|070|H|bar, use it instead of soap once or twice a day. Wet the skin||
0181|071|H|before applying, gently work up a lather for 10 to 20 seconds,||
0181|072|H|and rinse thoroughly. Do not scrub the skin.||
0181|073|H|   If using the shaving cream, first wet the area to be shaved.||
0181|074|H|Apply a small amount of the medication, gently rub into the area,||
0181|075|H|and then shave.||
0181|076|H|   If you are using a cream, foam, lotion, or gel, apply it to||
0181|077|H|the affected area as directed, usually once or twice a day.||
0181|078|H|Before applying each dose, gently wash the affected area with a||
0181|079|H|mild cleanser, then pat dry. Apply a small amount of medicine to||
0181|080|H|the affected area and rub in gently. Some products may require||
0181|081|H|rinsing off after application for a certain amount of time. Check||
0181|082|H|your product package to see if your form of this medication needs||
0181|083|H|to be rinsed off.||
0181|084|H|   If you are using the medicated pads or sponges, wash the||
0181|085|H|affected skin with a mild cleanser, then pat dry. Wipe the pad or||
0181|086|H|sponge gently onto the skin to apply the medication, usually once||
0181|087|H|or twice a day to the skin as directed.||
0181|088|H|   The dosage is based on your medical condition and response to||
0181|089|H|treatment. Improvement in acne or rosacea is usually seen after 3||
0181|090|H|to 4 weeks of use, and maximum benefit after 8 to 12 weeks of||
0181|091|H|use. Do not increase your dose or use this drug more often or for||
0181|092|H|longer than directed. Your condition will not improve any faster,||
0181|093|H|and your risk of side effects will increase.||
0181|094|H|   If your condition lasts or gets worse, or if you think you may||
0181|095|H|have a serious medical problem, get medical help right away.||
0181|096|B|||
0181|097|S|SIDE EFFECTS:  Skin reactions such as peeling, itching,||
0181|098|S|irritation, and reddened skin may occur, especially at the start||
0181|099|S|of treatment. If any of these effects last or get worse, tell||
0181|100|S|your doctor or pharmacist promptly. You may need to apply smaller||
0181|101|S|amounts of the drug or use it less often. Consult your doctor or||
0181|102|S|pharmacist for more details.||
0181|103|S|   If your doctor has directed you to use this medication,||
0181|104|S|remember that your doctor has judged that the benefit to you is||
0181|105|S|greater than the risk of side effects. Many people using this||
0181|106|S|medication do not have serious side effects.||
0181|107|S|   A very serious allergic reaction to this drug is rare.||
0181|108|S|However, get medical help right away if you notice any symptoms||
0181|109|S|of a serious allergic reaction, including: rash, itching/swelling||
0181|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0181|111|S|breathing.||
0181|112|S|   This is not a complete list of possible side effects. If you||
0181|113|S|notice other effects not listed above, contact your doctor or||
0181|114|S|pharmacist.||
0181|115|S|   In the US -||
0181|116|S|   Call your doctor for medical advice about side effects. You||
0181|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0181|118|S|www.fda.gov/medwatch.||
0181|119|S|   In Canada - Call your doctor for medical advice about side||
0181|120|S|effects. You may report side effects to Health Canada at||
0181|121|S|1-866-234-2345.||
0181|122|B|||
0181|123|P|PRECAUTIONS:  Before using benzoyl peroxide, tell your doctor or||
0181|124|P|pharmacist if you are allergic to it; or if you have any other||
0181|125|P|allergies. This product may contain inactive ingredients (such as||
0181|126|P|perfumes), which can cause allergic reactions or other problems.||
0181|127|P|Talk to your pharmacist for more details.||
0181|128|P|   Before using this medication, tell your doctor or pharmacist||
0181|129|P|your medical history.||
0181|130|P|   Before having surgery, tell your doctor or dentist about all||
0181|131|P|the products you use (including prescription drugs,||
0181|132|P|nonprescription drugs, and herbal products).||
0181|133|P|   This medication may make you more sensitive to the sun. Limit||
0181|134|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0181|135|P|sunscreen and wear protective clothing when outdoors. Tell your||
0181|136|P|doctor right away if you get sunburned or have skin||
0181|137|P|blisters/redness.||
0181|138|P|   During pregnancy, this medication should be used only when||
0181|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
0181|140|P|   It is unknown if this drug passes into breast milk. Consult||
0181|141|P|your doctor before breastfeeding.||
0181|142|B|||
0181|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0181|144|I|medications work or increase your risk for serious side effects.||
0181|145|I|This document does not contain all possible drug interactions.||
0181|146|I|Keep a list of all the products you use (including||
0181|147|I|prescription/nonprescription drugs and herbal products) and share||
0181|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
0181|149|I|the dosage of any medicines without your doctor's approval.||
0181|150|I|   A product that may interact with this drug is: dapsone used on||
0181|151|I|the skin.||
0181|152|B|||
0181|153|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0181|154|O|has overdosed and has serious symptoms such as passing out or||
0181|155|O|trouble breathing, call 911. Otherwise, call a poison control||
0181|156|O|center right away. US residents can call 1-800-222-1222. Canada||
0181|157|O|residents can call 1-844-764-7669.||
0181|158|B|||
0181|159|N|NOTES:  Keep all medical and lab appointments.||
0181|160|B|||
0181|161|D|MISSED DOSE:  If you are using this product on a regular schedule||
0181|162|D|and miss a dose, use it as soon as you remember. If it is near||
0181|163|D|the time of the next dose, skip the missed dose. Use your next||
0181|164|D|dose at the regular time. Do not double the dose to catch up.||
0181|165|B|||
0181|166|R|STORAGE:  Store at room temperature. Different brands of this||
0181|167|R|medication have different storage needs. Check the product||
0181|168|R|package for instructions on how to store your brand, or ask your||
0181|169|R|pharmacist. Keep all medications away from children and pets.||
0181|170|R|   Do not flush medications down the toilet or pour them into a||
0181|171|R|drain unless instructed to do so. Properly discard this product||
0181|172|R|when it is expired or no longer needed. Consult your pharmacist||
0181|173|R|or local waste disposal company.||
0181|174|B|||
0181|175|A|Information last revised February 2025.||
0181|176|A|Copyright(c) 2025 First Databank, Inc.||
0181|177|B|||
0182|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0182|002|Z|does NOT have all possible information about this product. This||
0182|003|Z|information does not assure that this product is safe, effective,||
0182|004|Z|or appropriate for you. This information is not individual||
0182|005|Z|medical advice and does not substitute for the advice of your||
0182|006|Z|health care professional. Always ask your health care||
0182|007|Z|professional for complete information about this product and your||
0182|008|Z|specific health needs.||
0182|009|B|||
0182|010|T|MILRINONE - INJECTION||
0182|011|F|(MIL-ri-none)||
0182|012|B|||
0182|013|C|COMMON BRAND NAME(S): Primacor||
0182|014|B|||
0182|015|U|USES:  This medication is used for the short-term treatment of||
0182|016|U|heart failure. It works by making your heart beat stronger and by||
0182|017|U|relaxing certain blood vessels so that the amount of blood that||
0182|018|U|is pumped from the heart is increased. This effect may help with||
0182|019|U|symptoms of heart failure (such as shortness of breath,||
0182|020|U|tiredness).||
0182|021|B|||
0182|022|H|HOW TO USE:  This medication is given by injection into a vein as||
0182|023|H|directed by your doctor. It is usually first given as a slow||
0182|024|H|injection (over 10 minutes) and then given as a continuous||
0182|025|H|infusion thereafter.||
0182|026|H|   If you are giving this medication to yourself at home, learn||
0182|027|H|all preparation and usage instructions from your health care||
0182|028|H|professional. Before using, check this product for particles or||
0182|029|H|discoloration. If either is present, do not use the liquid. Learn||
0182|030|H|how to store and discard medical supplies safely.||
0182|031|H|   Dosage is based on your medical condition, weight, and||
0182|032|H|response to treatment.||
0182|033|B|||
0182|034|S|SIDE EFFECTS:  Headaches may occur. If this effect lasts or gets||
0182|035|S|worse, tell your doctor promptly.||
0182|036|S|   Remember that this medication has been prescribed because your||
0182|037|S|doctor has judged that the benefit to you is greater than the||
0182|038|S|risk of side effects. Many people using this medication do not||
0182|039|S|have serious side effects.||
0182|040|S|   Tell your doctor right away if you have any serious side||
0182|041|S|effects, including: pain/redness/swelling at the injection site,||
0182|042|S|fast/irregular heartbeat, dizziness, fainting, chest pain.||
0182|043|S|   A very serious allergic reaction to this drug is rare.||
0182|044|S|However, get medical help right away if you notice any symptoms||
0182|045|S|of a serious allergic reaction, including: rash, itching/swelling||
0182|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0182|047|S|breathing.||
0182|048|S|   This is not a complete list of possible side effects. If you||
0182|049|S|notice other effects not listed above, contact your doctor or||
0182|050|S|pharmacist.||
0182|051|S|   In the US -||
0182|052|S|   Call your doctor for medical advice about side effects. You||
0182|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0182|054|S|www.fda.gov/medwatch.||
0182|055|S|   In Canada - Call your doctor for medical advice about side||
0182|056|S|effects. You may report side effects to Health Canada at||
0182|057|S|1-866-234-2345.||
0182|058|B|||
0182|059|P|PRECAUTIONS:  Before using milrinone, tell your doctor or||
0182|060|P|pharmacist if you are allergic to it, or if you have any other||
0182|061|P|allergies. This product may contain inactive ingredients, which||
0182|062|P|can cause allergic reactions or other problems. Talk to your||
0182|063|P|pharmacist for more details.||
0182|064|P|   Before using this medication, tell your doctor or pharmacist||
0182|065|P|your medical history, especially of: heart valve disease, kidney||
0182|066|P|disease, mineral imbalance (low level of potassium in the blood),||
0182|067|P|irregular heartbeat (such as atrial fibrillation).||
0182|068|P|   During pregnancy, this medication should be used only when||
0182|069|P|clearly needed. Discuss the risks and benefits with your doctor.||
0182|070|P|   It is unknown if this medication passes into breast milk.||
0182|071|P|Consult your doctor before breastfeeding.||
0182|072|B|||
0182|073|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0182|074|I|medications work or increase your risk for serious side effects.||
0182|075|I|This document does not contain all possible drug interactions.||
0182|076|I|Keep a list of all the products you use (including||
0182|077|I|prescription/nonprescription drugs and herbal products) and share||
0182|078|I|it with your doctor and pharmacist. Do not start, stop, or change||
0182|079|I|the dosage of any medicines without your doctor's approval.||
0182|080|I|   Some products have ingredients that could worsen your heart||
0182|081|I|failure. Tell your pharmacist what products you are using, and||
0182|082|I|ask how to use them safely (especially cough-and-cold products,||
0182|083|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0182|084|B|||
0182|085|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0182|086|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0182|087|O|poison control center right away. US residents can call||
0182|088|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0182|089|O|Symptoms of overdose may include: severe dizziness, fainting.||
0182|090|B|||
0182|091|N|NOTES:  Lab and/or medical tests (such as blood pressure, heart||
0182|092|N|rate/rhythm, kidney function, blood mineral levels) should be||
0182|093|N|done while you are using this medication. Keep all medical and||
0182|094|N|lab appointments. Consult your doctor for more details.||
0182|095|B|||
0182|096|D|MISSED DOSE:  This drug is to be given continuously as an||
0182|097|D|infusion. If your infusion is interrupted, contact your doctor or||
0182|098|D|pharmacist right away.||
0182|099|B|||
0182|100|R|STORAGE:  Consult the product instructions and your pharmacist||
0182|101|R|for storage details. Keep all medications away from children and||
0182|102|R|pets.||
0182|103|R|   Do not flush medications down the toilet or pour them into a||
0182|104|R|drain unless instructed to do so. Properly discard this product||
0182|105|R|when it is expired or no longer needed. Consult your pharmacist||
0182|106|R|or local waste disposal company.||
0182|107|B|||
0182|108|A|Information last revised November 2024.||
0182|109|A|Copyright(c) 2025 First Databank, Inc.||
0182|110|B|||
0183|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0183|002|Z|does NOT have all possible information about this product. This||
0183|003|Z|information does not assure that this product is safe, effective,||
0183|004|Z|or appropriate for you. This information is not individual||
0183|005|Z|medical advice and does not substitute for the advice of your||
0183|006|Z|health care professional. Always ask your health care||
0183|007|Z|professional for complete information about this product and your||
0183|008|Z|specific health needs.||
0183|009|B|||
0183|010|T|DAPSONE - ORAL||
0183|011|F|(DAP-sone)||
0183|012|B|||
0183|013|C|COMMON BRAND NAME(S): Avlosulfon||
0183|014|B|||
0183|015|U|USES:  This medication is used to treat a certain type of skin||
0183|016|U|disorder (dermatitis herpetiformis). It is also used with other||
0183|017|U|drugs to treat Hansen's disease. Dapsone belongs to a class of||
0183|018|U|drugs known as sulfones. It works by decreasing swelling||
0183|019|U|(inflammation) and stopping the growth of bacteria.||
0183|020|U|   This medication will not work for viral infections (such as||
0183|021|U|common cold, flu). Unnecessary use or misuse of any antibiotic||
0183|022|U|can lead to its decreased effectiveness.||
0183|023|B|||
0183|024|V|OTHER USES:  This section contains uses of this drug that are not||
0183|025|V|listed in the approved professional labeling for the drug but||
0183|026|V|that may be prescribed by your health care professional. Use this||
0183|027|V|drug for a condition that is listed in this section only if it||
0183|028|V|has been so prescribed by your health care professional.||
0183|029|V|   This drug may also be used for skin conditions in certain||
0183|030|V|immune system disorders (such as systemic lupus||
0183|031|V|erythematosus-SLE) or for a certain lung infection due to HIV||
0183|032|V|(pneumocystis pneumonia). It may also be used to reduce the risk||
0183|033|V|of a certain brain infection due to HIV (toxoplasmosis).||
0183|034|B|||
0183|035|H|HOW TO USE:  Take this medication by mouth with or without food||
0183|036|H|as directed by your doctor, usually once daily.||
0183|037|H|   If you are taking dapsone for a skin disorder, your doctor may||
0183|038|H|start you on a low dose of dapsone and gradually adjust your dose||
0183|039|H|to control your disease. If you are taking this medication to||
0183|040|H|treat Hansen's disease or to prevent infections due to HIV, the||
0183|041|H|drug is usually taken for years or for life.||
0183|042|H|   The dosage is based on your medical condition and response to||
0183|043|H|treatment. Children's dosage is also based on age and weight.||
0183|044|H|   For the best effect, take this antibiotic at evenly spaced||
0183|045|H|times. To help you remember, take this medication at the same||
0183|046|H|time(s) every day.||
0183|047|H|   Tell your doctor if your condition gets worse.||
0183|048|B|||
0183|049|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, dizziness, or||
0183|050|S|blurred vision may occur. If any of these effects last or get||
0183|051|S|worse, tell your doctor or pharmacist promptly.||
0183|052|S|   Remember that this medication has been prescribed because your||
0183|053|S|doctor has judged that the benefit to you is greater than the||
0183|054|S|risk of side effects. Many people using this medication do not||
0183|055|S|have serious side effects.||
0183|056|S|   Tell your doctor right away if you have any serious side||
0183|057|S|effects, including: unusually fast heartbeat, unusually fast||
0183|058|S|breathing, bluish lips/skin, chest pain, mental/mood changes,||
0183|059|S|muscle weakness, difficulty urinating.||
0183|060|S|   This drug may rarely cause very serious low blood counts (bone||
0183|061|S|marrow suppression) or liver disease. Get medical help right away||
0183|062|S|if you develop signs of an infection (such as sore throat that||
0183|063|S|doesn't go away, fever, chills), easy bruising/bleeding, unusual||
0183|064|S|tiredness, pale skin, yellowing eyes/skin, dark urine,||
0183|065|S|stomach/abdominal pain.||
0183|066|S|   Dapsone can commonly cause a rash that is usually not serious.||
0183|067|S|However, you may not be able to tell it apart from a rare rash||
0183|068|S|that could be a sign of a severe reaction. Get medical help right||
0183|069|S|away if you develop any rash.||
0183|070|S|   A very serious allergic reaction to this drug is rare.||
0183|071|S|However, get medical help right away if you notice any symptoms||
0183|072|S|of a serious allergic reaction, including: rash, itching/swelling||
0183|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0183|074|S|breathing.||
0183|075|S|   This is not a complete list of possible side effects. If you||
0183|076|S|notice other effects not listed above, contact your doctor or||
0183|077|S|pharmacist.||
0183|078|S|   In the US -||
0183|079|S|   Call your doctor for medical advice about side effects. You||
0183|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0183|081|S|www.fda.gov/medwatch.||
0183|082|S|   In Canada - Call your doctor for medical advice about side||
0183|083|S|effects. You may report side effects to Health Canada at||
0183|084|S|1-866-234-2345.||
0183|085|B|||
0183|086|P|PRECAUTIONS:  Before taking dapsone, tell your doctor or||
0183|087|P|pharmacist if you are allergic to it; or to similar drugs such as||
0183|088|P|sulfoxone; or if you have any other allergies. This product may||
0183|089|P|contain inactive ingredients, which can cause allergic reactions||
0183|090|P|or other problems. Talk to your pharmacist for more details.||
0183|091|P|   Before using this medication, tell your doctor or pharmacist||
0183|092|P|your medical history, especially of: certain blood disorders||
0183|093|P|(such as anemia, G6PD deficiency, methemoglobin reductase||
0183|094|P|deficiency), liver disease, heart disease, lung disease, serious||
0183|095|P|infection, very high blood sugar (diabetic ketosis).||
0183|096|P|   If using this drug to treat Hansen's disease, note that as||
0183|097|P|your immune system helps fight the infection, you may notice skin||
0183|098|P|sores worsening, and numbness/pain/tingling or muscle weakness.||
0183|099|P|This may require special treatment, so tell your doctor right||
0183|100|P|away if these symptoms occur.||
0183|101|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0183|102|P|can make you more dizzy. Do not drive, use machinery, or do||
0183|103|P|anything that needs alertness until you can do it safely. Limit||
0183|104|P|alcoholic beverages. Talk to your doctor if you are using||
0183|105|P|marijuana (cannabis).||
0183|106|P|   Before having surgery, tell your doctor or dentist about all||
0183|107|P|the products you use (including prescription drugs,||
0183|108|P|nonprescription drugs, and herbal products).||
0183|109|P|   During pregnancy, this medication should be used only when||
0183|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
0183|111|P|   This medication passes into breast milk and may have||
0183|112|P|undesirable effects on a nursing infant. Consult your doctor||
0183|113|P|before breastfeeding.||
0183|114|B|||
0183|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0183|116|I|medications work or increase your risk for serious side effects.||
0183|117|I|This document does not contain all possible drug interactions.||
0183|118|I|Keep a list of all the products you use (including||
0183|119|I|prescription/nonprescription drugs and herbal products) and share||
0183|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
0183|121|I|the dosage of any medicines without your doctor's approval.||
0183|122|I|   Some products that may interact with this drug are: folic acid||
0183|123|I|antagonists (such as pyrimethamine), nitrofurantoin, primaquine.||
0183|124|B|||
0183|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0183|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0183|127|O|poison control center right away. US residents can call||
0183|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0183|129|O|Symptoms of overdose may include: seizures, bluish skin||
0183|130|O|(cyanosis), sudden vision changes, sudden loss of vision.||
0183|131|B|||
0183|132|N|NOTES:  Do not share this medication with others.||
0183|133|N|   Lab and/or medical tests (such as complete blood||
0183|134|N|counts/platelets, liver function) should be done while you are||
0183|135|N|taking this medication. Keep all medical and lab appointments.||
0183|136|N|Consult your doctor for more details.||
0183|137|N|   Iron, folic acid, and vitamin C might reduce the risk of||
0183|138|N|developing a certain serious side effect (anemia). Ask your||
0183|139|N|doctor for more details.||
0183|140|N|   If you are using dapsone for dermatitis herpetiformis, a||
0183|141|N|gluten-free diet may improve the condition. Consult your doctor||
0183|142|N|for more information.||
0183|143|B|||
0183|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0183|145|D|remember. If it is near the time of the next dose, skip the||
0183|146|D|missed dose. Take your next dose at the regular time. Do not||
0183|147|D|double the dose to catch up.||
0183|148|B|||
0183|149|R|STORAGE:  Store at room temperature away from light and moisture.||
0183|150|R|Do not store in the bathroom. Keep all medications away from||
0183|151|R|children and pets.||
0183|152|R|   Do not flush medications down the toilet or pour them into a||
0183|153|R|drain unless instructed to do so. Properly discard this product||
0183|154|R|when it is expired or no longer needed. Consult your pharmacist||
0183|155|R|or local waste disposal company.||
0183|156|B|||
0183|157|A|Information last revised May 2025.||
0183|158|A|Copyright(c) 2025 First Databank, Inc.||
0183|159|B|||
0184|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0184|002|Z|does NOT have all possible information about this product. This||
0184|003|Z|information does not assure that this product is safe, effective,||
0184|004|Z|or appropriate for you. This information is not individual||
0184|005|Z|medical advice and does not substitute for the advice of your||
0184|006|Z|health care professional. Always ask your health care||
0184|007|Z|professional for complete information about this product and your||
0184|008|Z|specific health needs.||
0184|009|B|||
0184|010|T|ALPHA-1-PROTEINASE INHIBITOR - INJECTION||
0184|011|B|||
0184|012|C|COMMON BRAND NAME(S): Glassia, Prolastin, Zemaira||
0184|013|B|||
0184|014|U|USES:  This medication is used to treat lung problems (emphysema)||
0184|015|U|caused by a certain inherited disease (alpha-1-proteinase||
0184|016|U|inhibitor deficiency). In people with this condition, lung damage||
0184|017|U|is caused by elastase, a natural substance that the body needs to||
0184|018|U|kill bacteria in the lungs. Normally, a protein||
0184|019|U|(alpha-1-proteinase inhibitor) stops elastase from working when||
0184|020|U|it is no longer needed. However, in people who do not make enough||
0184|021|U|of this protein, elastase does not stop working and damages the||
0184|022|U|lungs. This medication replaces the missing alpha-1-proteinase||
0184|023|U|inhibitor and helps to prevent further lung damage.||
0184|024|B|||
0184|025|H|HOW TO USE:  This medication is given by injection into a vein as||
0184|026|H|directed by your doctor, usually once a week.||
0184|027|H|   If you are giving this medication at home, learn all||
0184|028|H|preparation and usage instructions in the product package and||
0184|029|H|from your health care professional. If any of the information is||
0184|030|H|unclear, consult your doctor or pharmacist. If your brand of||
0184|031|H|medication is stored in the refrigerator, allow the medication||
0184|032|H|and mixing solution to warm to room temperature before mixing. Do||
0184|033|H|not shake the mixed drug. Doing so may decrease the effectiveness||
0184|034|H|of this medication.||
0184|035|H|   Before using, check this product for particles or||
0184|036|H|discoloration. Occasionally, a few small particles may remain in||
0184|037|H|the vial. These particles will be removed by the filter provided||
0184|038|H|with the medication. If the product is discolored, do not use the||
0184|039|H|liquid.||
0184|040|H|   Learn how to store and discard needles and medical supplies||
0184|041|H|safely. Consult your pharmacist for details.||
0184|042|H|   Dosage is based on your weight, medical condition and response||
0184|043|H|to treatment.||
0184|044|H|   Use this medication regularly to get the most benefit from it.||
0184|045|H|To help you remember, use it on the same day each week. Mark your||
0184|046|H|calendar with a reminder.||
0184|047|H|   Tell your doctor if your condition gets worse after several||
0184|048|H|weeks.||
0184|049|B|||
0184|050|S|SIDE EFFECTS:  Pain at the injection site, fever, dizziness,||
0184|051|S|headache, drowsiness, numb/tingling skin, and muscle aches may||
0184|052|S|occur. If any of these effects last or get worse, tell your||
0184|053|S|doctor or pharmacist promptly.||
0184|054|S|   Remember that this medication has been prescribed because your||
0184|055|S|doctor has judged that the benefit to you is greater than the||
0184|056|S|risk of side effects. Many people using this medication do not||
0184|057|S|have serious side effects.||
0184|058|S|   A very serious allergic reaction to this drug is rare.||
0184|059|S|However, get medical help right away if you notice any symptoms||
0184|060|S|of a serious allergic reaction, including: rash, itching/swelling||
0184|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0184|062|S|breathing.||
0184|063|S|   This is not a complete list of possible side effects. If you||
0184|064|S|notice other effects not listed above, contact your doctor or||
0184|065|S|pharmacist.||
0184|066|S|   In the US -||
0184|067|S|   Call your doctor for medical advice about side effects. You||
0184|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0184|069|S|www.fda.gov/medwatch.||
0184|070|S|   In Canada - Call your doctor for medical advice about side||
0184|071|S|effects. You may report side effects to Health Canada at||
0184|072|S|1-866-234-2345.||
0184|073|B|||
0184|074|P|PRECAUTIONS:  Before using alpha-1-proteinase inhibitor, tell||
0184|075|P|your doctor or pharmacist if you are allergic to it; or if you||
0184|076|P|have any other allergies. This product may contain inactive||
0184|077|P|ingredients, which can cause allergic reactions or other||
0184|078|P|problems. Talk to your pharmacist for more details.||
0184|079|P|   Before using this medication, tell your doctor or pharmacist||
0184|080|P|your medical history, especially of: selective IgA deficiency||
0184|081|P|with antibodies to IgA, liver disease, heart problems (such as||
0184|082|P|heart failure).||
0184|083|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0184|084|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0184|085|P|machinery, or do anything that needs alertness until you can do||
0184|086|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0184|087|P|are using marijuana (cannabis).||
0184|088|P|   This medication is made from human blood. Even though the||
0184|089|P|blood is carefully tested, and this medication goes through a||
0184|090|P|special manufacturing process, there is an extremely small chance||
0184|091|P|that you may get infections from the medication (for example,||
0184|092|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
0184|093|P|more information.||
0184|094|P|   During pregnancy, this medication should be used only when||
0184|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
0184|096|P|   It is unknown if this drug passes into breast milk. Consult||
0184|097|P|your doctor before breastfeeding.||
0184|098|B|||
0184|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0184|100|I|medications work or increase your risk for serious side effects.||
0184|101|I|This document does not contain all possible drug interactions.||
0184|102|I|Keep a list of all the products you use (including||
0184|103|I|prescription/nonprescription drugs and herbal products) and share||
0184|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
0184|105|I|the dosage of any medicines without your doctor's approval.||
0184|106|B|||
0184|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0184|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0184|109|O|poison control center right away. US residents can call||
0184|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0184|111|B|||
0184|112|N|NOTES:  Do not share this medication with others.||
0184|113|N|   Lab and/or medical tests (such as lung function) should be||
0184|114|N|done while you are using this medication. Keep all medical and||
0184|115|N|lab appointments. Consult your doctor for more details.||
0184|116|B|||
0184|117|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
0184|118|D|right away for a new dosing schedule.||
0184|119|B|||
0184|120|R|STORAGE:  Different brands of this medication have different||
0184|121|R|storage requirements. Ask your pharmacist how to store your||
0184|122|R|brand. Do not freeze. After mixing this drug, do not refrigerate.||
0184|123|R|Use the mixed drug within 3 hours. Discard any unused portion.||
0184|124|R|Keep all medications away from children and pets.||
0184|125|R|   Do not flush medications down the toilet or pour them into a||
0184|126|R|drain unless instructed to do so. Properly discard this product||
0184|127|R|when it is expired or no longer needed. Consult your pharmacist||
0184|128|R|or local waste disposal company.||
0184|129|B|||
0184|130|A|Information last revised January 2025.||
0184|131|A|Copyright(c) 2025 First Databank, Inc.||
0184|132|B|||
0185|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0185|002|Z|does NOT have all possible information about this product. This||
0185|003|Z|information does not assure that this product is safe, effective,||
0185|004|Z|or appropriate for you. This information is not individual||
0185|005|Z|medical advice and does not substitute for the advice of your||
0185|006|Z|health care professional. Always ask your health care||
0185|007|Z|professional for complete information about this product and your||
0185|008|Z|specific health needs.||
0185|009|B|||
0185|010|T|FLUOROMETHOLONE SUSPENSION - OPHTHALMIC||
0185|011|F|(FLOOR-oh-METH-oh-lone)||
0185|012|B|||
0185|013|C|COMMON BRAND NAME(S): FML, FML Forte||
0185|014|B|||
0185|015|U|USES:  This medication is used to treat certain eye conditions||
0185|016|U|due to inflammation or injury. Fluorometholone works by relieving||
0185|017|U|symptoms such as swelling, redness, and itching. It belongs to a||
0185|018|U|class of drugs known as corticosteroids.||
0185|019|B|||
0185|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0185|021|H|directed by your doctor, usually 2 to 4 times a day.||
0185|022|H|   Unless otherwise directed by your doctor, do not wear contact||
0185|023|H|lenses while you are using this medicine. Sterilize contact||
0185|024|H|lenses according to the manufacturer's directions, and check with||
0185|025|H|your doctor before you begin using them again.||
0185|026|H|   If your doctor does approve the wearing of contact lenses||
0185|027|H|during treatment with this medication, remove the lenses before||
0185|028|H|using the eye drops. The preservative in this product may be||
0185|029|H|absorbed by contact lenses. Wait at least 15 minutes after each||
0185|030|H|dose of the eye drop before wearing the lenses again.||
0185|031|H|   To apply eye drops, wash your hands first. Shake the bottle||
0185|032|H|well before using. To avoid contamination, do not touch the||
0185|033|H|dropper tip or let it touch your eye or any other surface.||
0185|034|H|   Tilt your head back, look upward, and pull down the lower||
0185|035|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0185|036|H|and place 1 drop into the pouch. Look downward and gently close||
0185|037|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0185|038|H|your eye (near the nose) and apply gentle pressure. This will||
0185|039|H|prevent the medication from draining out. Try not to blink and do||
0185|040|H|not rub your eye. Repeat these steps for your other eye if so||
0185|041|H|directed and if your dose is for more than 1 drop.||
0185|042|H|   Do not rinse the dropper. Replace the dropper cap after each||
0185|043|H|use.||
0185|044|H|   If you are using another kind of eye medication (for example,||
0185|045|H|other drops or ointments), wait at least 5 to 10 minutes before||
0185|046|H|applying other medications. Use eye drops before eye ointments to||
0185|047|H|allow the drops to enter the eye.||
0185|048|H|   Wait several minutes for your vision to clear before driving||
0185|049|H|or operating machinery.||
0185|050|H|   Use this medication regularly in order to get the most benefit||
0185|051|H|from it. To help you remember, use it at the same time(s) each||
0185|052|H|day.||
0185|053|H|   The dosage and length of treatment are based on your medical||
0185|054|H|condition and response to treatment. Do not use this medication||
0185|055|H|more often or for longer than prescribed because doing so may||
0185|056|H|increase your risk of side effects.||
0185|057|H|   Continue to use this medication for the full time prescribed.||
0185|058|H|Do not stop using this medication without consulting your doctor.||
0185|059|H|Some conditions may become worse when the drug is suddenly||
0185|060|H|stopped. Your dose may need to be gradually decreased.||
0185|061|H|   Do not use this product if it becomes contaminated (for||
0185|062|H|example, drops turn a dark color). Use of contaminated eye||
0185|063|H|medication can cause infection, serious damage to the eye, and||
0185|064|H|loss of vision. Contact your doctor or pharmacist for more||
0185|065|H|information.||
0185|066|H|   Tell your doctor if your condition does not get better after 2||
0185|067|H|days or if it gets worse.||
0185|068|B|||
0185|069|S|SIDE EFFECTS:  Stinging/burning of the eyes for 1 to 2 minutes||
0185|070|S|and temporary blurred vision may occur when you apply this||
0185|071|S|medication. If any of these effects last or get worse, tell your||
0185|072|S|doctor or pharmacist promptly.||
0185|073|S|   Remember that this medication has been prescribed because your||
0185|074|S|doctor has judged that the benefit to you is greater than the||
0185|075|S|risk of side effects. Many people using this medication do not||
0185|076|S|have serious side effects.||
0185|077|S|   Use of this medication for prolonged periods or in high doses||
0185|078|S|may cause serious eye problems (such as high pressure inside the||
0185|079|S|eyes and cataracts). Tell your doctor right away if any of these||
0185|080|S|serious side effects occur: vision problems, eye pain.||
0185|081|S|   This medication may mask the signs of an eye infection. It may||
0185|082|S|also put you at greater risk of developing an eye infection,||
0185|083|S|especially with prolonged use. Report any new or worsening||
0185|084|S|symptoms such as eye discharge/swelling/redness, vision problems,||
0185|085|S|or no improvement of your current eye condition. Your doctor will||
0185|086|S|need to adjust your treatment.||
0185|087|S|   Tell your doctor right away if you have any serious side||
0185|088|S|effects, including: headache, dizziness.||
0185|089|S|   A very serious allergic reaction to this drug is rare.||
0185|090|S|However, get medical help right away if you notice any symptoms||
0185|091|S|of a serious allergic reaction, including: rash, itching/swelling||
0185|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0185|093|S|breathing.||
0185|094|S|   This is not a complete list of possible side effects. If you||
0185|095|S|notice other effects not listed above, contact your doctor or||
0185|096|S|pharmacist.||
0185|097|S|   In the US -||
0185|098|S|   Call your doctor for medical advice about side effects. You||
0185|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0185|100|S|www.fda.gov/medwatch.||
0185|101|S|   In Canada - Call your doctor for medical advice about side||
0185|102|S|effects. You may report side effects to Health Canada at||
0185|103|S|1-866-234-2345.||
0185|104|B|||
0185|105|P|PRECAUTIONS:  Before using fluorometholone, tell your doctor or||
0185|106|P|pharmacist if you are allergic to it; or if you have any other||
0185|107|P|allergies. This product may contain inactive ingredients, which||
0185|108|P|can cause allergic reactions or other problems. Talk to your||
0185|109|P|pharmacist for more details.||
0185|110|P|   Before using this medication, tell your doctor or pharmacist||
0185|111|P|your medical history, especially of: eye infections, recent eye||
0185|112|P|surgery, cataracts, glaucoma (open-angle type), severe||
0185|113|P|nearsightedness (myopia), diabetes.||
0185|114|P|   After you apply this drug, your vision may become temporarily||
0185|115|P|blurred. Do not drive, use machinery, or do anything that needs||
0185|116|P|clear vision until you can do it safely.||
0185|117|P|   Before having surgery, tell your doctor or dentist about all||
0185|118|P|the products you use (including prescription drugs,||
0185|119|P|nonprescription drugs, and herbal products).||
0185|120|P|   If you develop a new eye infection or injury, or require eye||
0185|121|P|surgery, ask your doctor if you should continue to use your||
0185|122|P|current bottle of fluorometholone eye drops or start a new||
0185|123|P|bottle.||
0185|124|P|   During pregnancy, this medication should be used only when||
0185|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
0185|126|P|   It is unknown if this medication passes into breast milk.||
0185|127|P|Consult your doctor before breastfeeding.||
0185|128|B|||
0185|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0185|130|I|medications work or increase your risk for serious side effects.||
0185|131|I|This document does not contain all possible drug interactions.||
0185|132|I|Keep a list of all the products you use (including||
0185|133|I|prescription/nonprescription drugs and herbal products) and share||
0185|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
0185|135|I|the dosage of any medicines without your doctor's approval.||
0185|136|B|||
0185|137|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0185|138|O|has overdosed and has serious symptoms such as passing out or||
0185|139|O|trouble breathing, call 911. Otherwise, call a poison control||
0185|140|O|center right away. US residents can call 1-800-222-1222. Canada||
0185|141|O|residents can call 1-844-764-7669.||
0185|142|B|||
0185|143|N|NOTES:  Do not share this medication with others.||
0185|144|N|   This medication has been prescribed for your current condition||
0185|145|N|only. Do not use it later for another eye condition unless told||
0185|146|N|to do so by your doctor. A different medication may be necessary||
0185|147|N|in that case.||
0185|148|N|   Lab and/or medical tests (such as eye exams, measurement of||
0185|149|N|the pressure inside the eyes) may be done while you are using||
0185|150|N|this medication. Keep all medical and lab appointments. Consult||
0185|151|N|your doctor for more details.||
0185|152|B|||
0185|153|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0185|154|D|If it is near the time of the next dose, skip the missed dose.||
0185|155|D|Use your next dose at the regular time. Do not double the dose to||
0185|156|D|catch up.||
0185|157|B|||
0185|158|R|STORAGE:  Different brands of this medication have different||
0185|159|R|storage needs. Check the product package for instructions on how||
0185|160|R|to store your brand, or ask your pharmacist. Do not freeze. Keep||
0185|161|R|the bottle upright. Keep all medications away from children and||
0185|162|R|pets.||
0185|163|R|   Do not flush medications down the toilet or pour them into a||
0185|164|R|drain unless instructed to do so. Properly discard this product||
0185|165|R|when it is expired or no longer needed. Consult your pharmacist||
0185|166|R|or local waste disposal company.||
0185|167|B|||
0185|168|A|Information last revised October 2024.||
0185|169|A|Copyright(c) 2025 First Databank, Inc.||
0185|170|B|||
0186|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0186|002|Z|does NOT have all possible information about this product. This||
0186|003|Z|information does not assure that this product is safe, effective,||
0186|004|Z|or appropriate for you. This information is not individual||
0186|005|Z|medical advice and does not substitute for the advice of your||
0186|006|Z|health care professional. Always ask your health care||
0186|007|Z|professional for complete information about this product and your||
0186|008|Z|specific health needs.||
0186|009|B|||
0186|010|T|DICLOFENAC - OPHTHALMIC||
0186|011|F|(dye-KLOE-fen-ak)||
0186|012|B|||
0186|013|C|COMMON BRAND NAME(S): Voltaren||
0186|014|B|||
0186|015|U|USES:  This medication is used to treat swelling (inflammation)||
0186|016|U|of the eye after cataract surgery. It is also used after another||
0186|017|U|type of eye surgery (corneal refractive surgery) to temporarily||
0186|018|U|relieve pain and sensitivity of the eye to light. Diclofenac||
0186|019|U|belongs to a class of drugs known as nonsteroidal||
0186|020|U|anti-inflammatory drugs (NSAIDs).||
0186|021|B|||
0186|022|V|OTHER USES:  This section contains uses of this drug that are not||
0186|023|V|listed in the approved professional labeling for the drug but||
0186|024|V|that may be prescribed by your health care professional. Use this||
0186|025|V|drug for a condition that is listed in this section only if it||
0186|026|V|has been so prescribed by your health care professional.||
0186|027|V|   This drug may also be used for swelling from other eye||
0186|028|V|conditions due to inflammation or injury.||
0186|029|B|||
0186|030|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0186|031|H|directed by your doctor, usually 4 to 5 times a day. The dosage||
0186|032|H|and duration of treatment is based on your medical condition and||
0186|033|H|response to treatment.||
0186|034|H|   Do not wear contact lenses while you are using this medicine||
0186|035|H|unless your doctor approves of it. Sterilize contact lenses||
0186|036|H|according to the manufacturer's directions, and check with your||
0186|037|H|doctor before you begin using them again.||
0186|038|H|   To apply eye drops, wash your hands first. To avoid||
0186|039|H|contamination, do not touch the dropper tip or let it touch your||
0186|040|H|eye or any other surface.||
0186|041|H|   Tilt your head back, look upward, and pull down the lower||
0186|042|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0186|043|H|and place 1 drop into the pouch. Look downward and gently close||
0186|044|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0186|045|H|your eye (near the nose) and apply gentle pressure. This will||
0186|046|H|prevent the medication from draining out. Try not to blink and do||
0186|047|H|not rub your eye. Repeat these steps if your dose is for more||
0186|048|H|than 1 drop.||
0186|049|H|   Do not rinse the dropper. Replace the dropper cap after each||
0186|050|H|use. If you are using the single dose units, discard the unit and||
0186|051|H|any remaining solution after one use.||
0186|052|H|   If you are using another kind of eye medication (for example,||
0186|053|H|other drops or ointments), wait at least 5 to 10 minutes before||
0186|054|H|applying other medications. Use eye drops before eye ointments to||
0186|055|H|allow the drops to enter the eye.||
0186|056|H|   Wait several minutes for your vision to clear before driving||
0186|057|H|or operating machinery.||
0186|058|H|   This medication is intended for short-term use only. Do not||
0186|059|H|use this medication more often or for longer than prescribed||
0186|060|H|because doing so may increase your risk of serious side effects.||
0186|061|H|   Do not use this product if it becomes contaminated (for||
0186|062|H|example, drops turn cloudy or a dark color). Use of contaminated||
0186|063|H|eye medication can cause infection, serious damage to the eye,||
0186|064|H|and loss of vision. Contact your doctor or pharmacist for more||
0186|065|H|information.||
0186|066|H|   Tell your doctor if your symptoms last or if they get worse.||
0186|067|B|||
0186|068|S|SIDE EFFECTS:  Stinging/burning of the eyes for 1 to 2 minutes||
0186|069|S|and temporary blurred vision may occur when you apply this||
0186|070|S|medication. Watery eyes may also occur. If any of these effects||
0186|071|S|last or get worse, tell your doctor or pharmacist promptly.||
0186|072|S|   Remember that this medication has been prescribed because your||
0186|073|S|doctor has judged that the benefit to you is greater than the||
0186|074|S|risk of side effects. Many people using this medication do not||
0186|075|S|have serious side effects.||
0186|076|S|   Tell your doctor right away if you have any serious side||
0186|077|S|effects, including: eye pain, decreased vision, bleeding in the||
0186|078|S|eye (increased redness in the eye).||
0186|079|S|   A very serious allergic reaction to this drug is rare.||
0186|080|S|However, get medical help right away if you notice any symptoms||
0186|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0186|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0186|083|S|breathing.||
0186|084|S|   This is not a complete list of possible side effects. If you||
0186|085|S|notice other effects not listed above, contact your doctor or||
0186|086|S|pharmacist.||
0186|087|S|   In the US -||
0186|088|S|   Call your doctor for medical advice about side effects. You||
0186|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0186|090|S|www.fda.gov/medwatch.||
0186|091|S|   In Canada - Call your doctor for medical advice about side||
0186|092|S|effects. You may report side effects to Health Canada at||
0186|093|S|1-866-234-2345.||
0186|094|B|||
0186|095|P|PRECAUTIONS:  Before using diclofenac, tell your doctor or||
0186|096|P|pharmacist if you are allergic to it; or to aspirin or other||
0186|097|P|NSAIDs (such as ibuprofen, celecoxib); or if you have any other||
0186|098|P|allergies. This product may contain inactive ingredients (such as||
0186|099|P|polyoxyethylated castor oil found in some brands), which can||
0186|100|P|cause allergic reactions or other problems. Talk to your||
0186|101|P|pharmacist for more details.||
0186|102|P|   Before using this medication, tell your doctor or pharmacist||
0186|103|P|your medical history, especially of: asthma (including a history||
0186|104|P|of worsening breathing after taking aspirin or other NSAIDs),||
0186|105|P|growths in the nose (nasal polyps), bleeding or clotting||
0186|106|P|problems, other eye problems (such as cornea problems, dry eye||
0186|107|P|syndrome, past eye surgeries), diabetes, rheumatoid arthritis.||
0186|108|P|   After you apply this drug, your vision may become temporarily||
0186|109|P|blurred. Do not drive, use machinery, or do anything that needs||
0186|110|P|clear vision until you can do it safely.||
0186|111|P|   Before having surgery, tell your doctor or dentist about all||
0186|112|P|the products you use (including prescription drugs,||
0186|113|P|nonprescription drugs, and herbal products).||
0186|114|P|   During pregnancy, this medication should be used only when||
0186|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
0186|116|P|   This medication passes into breast milk, but is unlikely to||
0186|117|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0186|118|B|||
0186|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0186|120|I|medications work or increase your risk for serious side effects.||
0186|121|I|This document does not contain all possible drug interactions.||
0186|122|I|Keep a list of all the products you use (including||
0186|123|I|prescription/nonprescription drugs and herbal products) and share||
0186|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
0186|125|I|the dosage of any medicines without your doctor's approval.||
0186|126|I|   Some products that may interact with this drug include:||
0186|127|I|corticosteroids (such as prednisone).||
0186|128|I|   This medication may increase the risk of bleeding when used||
0186|129|I|with other drugs that also may cause bleeding. Examples include||
0186|130|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0186|131|I|dabigatran/enoxaparin/warfarin, among others.||
0186|132|I|   Check all prescription and nonprescription medicine labels||
0186|133|I|carefully since many medications contain pain relievers/fever||
0186|134|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These||
0186|135|I|drugs are similar to diclofenac and may increase your risk of||
0186|136|I|side effects if taken together. However, if your doctor has told||
0186|137|I|you to take low-dose aspirin to prevent heart attack or stroke||
0186|138|I|(usually 81-162 milligrams a day), you should keep taking the||
0186|139|I|aspirin unless your doctor tells you not to. Ask your doctor or||
0186|140|I|pharmacist for more details.||
0186|141|B|||
0186|142|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0186|143|O|has overdosed and has serious symptoms such as passing out or||
0186|144|O|trouble breathing, call 911. Otherwise, call a poison control||
0186|145|O|center right away. US residents can call 1-800-222-1222. Canada||
0186|146|O|residents can call 1-844-764-7669.||
0186|147|B|||
0186|148|N|NOTES:  Do not share this medication with others.||
0186|149|N|   This medication has been prescribed for your current condition||
0186|150|N|only. Do not use it later for another eye condition unless told||
0186|151|N|to do so by your doctor. A different medication may be necessary||
0186|152|N|in that case.||
0186|153|B|||
0186|154|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0186|155|D|If it is near the time of the next dose, skip the missed dose.||
0186|156|D|Use your next dose at the regular time. Do not double the dose to||
0186|157|D|catch up.||
0186|158|B|||
0186|159|R|STORAGE:  Store at room temperature according to the product||
0186|160|R|package instructions for your brand, or ask your pharmacist. Keep||
0186|161|R|all medications away from children and pets.||
0186|162|R|   Do not flush medications down the toilet or pour them into a||
0186|163|R|drain unless instructed to do so. Properly discard this product||
0186|164|R|when it is expired or no longer needed. Consult your pharmacist||
0186|165|R|or local waste disposal company.||
0186|166|B|||
0186|167|A|Information last revised September 2024.||
0186|168|A|Copyright(c) 2025 First Databank, Inc.||
0186|169|B|||
0187|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0187|002|Z|does NOT have all possible information about this product. This||
0187|003|Z|information does not assure that this product is safe, effective,||
0187|004|Z|or appropriate for you. This information is not individual||
0187|005|Z|medical advice and does not substitute for the advice of your||
0187|006|Z|health care professional. Always ask your health care||
0187|007|Z|professional for complete information about this product and your||
0187|008|Z|specific health needs.||
0187|009|B|||
0187|010|T|PENICILLAMINE - ORAL||
0187|011|F|(PEN-i-SIL-a-meen)||
0187|012|B|||
0187|013|C|COMMON BRAND NAME(S): Cuprimine, Depen||
0187|014|B|||
0187|015|U|USES:  This medication is used to treat rheumatoid arthritis,||
0187|016|U|Wilson's disease (a condition in which high levels of copper in||
0187|017|U|the body cause damage to the liver, brain, and other organs), and||
0187|018|U|a certain disorder which causes kidney stones (cystinuria). For||
0187|019|U|the treatment of rheumatoid arthritis, penicillamine is known as||
0187|020|U|a disease-modifying antirheumatic drug (DMARD). It helps to||
0187|021|U|decrease pain/tenderness/swelling in the joints. For the||
0187|022|U|treatment of Wilson's disease, penicillamine binds to copper and||
0187|023|U|helps it to be removed from the body. Decreasing copper levels||
0187|024|U|helps to improve liver function and the mental/mood/nerve||
0187|025|U|problems (such as confusion, difficulty speaking/walking) caused||
0187|026|U|by the disease. For the treatment of cystinuria, penicillamine||
0187|027|U|helps to decrease the amount of a certain substance (cystine) in||
0187|028|U|the urine which can cause kidney stones.||
0187|029|B|||
0187|030|V|OTHER USES:  This section contains uses of this drug that are not||
0187|031|V|listed in the approved professional labeling for the drug but||
0187|032|V|that may be prescribed by your health care professional. Use this||
0187|033|V|drug for a condition that is listed in this section only if it||
0187|034|V|has been so prescribed by your health care professional.||
0187|035|V|   This drug may also be used for lead poisoning.||
0187|036|B|||
0187|037|H|HOW TO USE:  Take this medication by mouth on an empty stomach (1||
0187|038|H|hour before or 2 hours after meals) as directed by your doctor.||
0187|039|H|Take this medication at least 1 hour apart from any other drug,||
0187|040|H|food, milk, antacid, zinc, or products containing iron. These||
0187|041|H|products may bind with penicillamine, preventing your body from||
0187|042|H|fully absorbing the drug.||
0187|043|H|   The dosage is based on your medical condition and response to||
0187|044|H|treatment.||
0187|045|H|   Use this medication regularly to get the most benefit from it.||
0187|046|H|To help you remember, take it at the same time(s) each day.||
0187|047|H|   For the treatment of rheumatoid arthritis, it may take 2 to 3||
0187|048|H|months before you see any improvement in your condition.||
0187|049|H|   For the treatment of Wilson's disease, follow the diet||
0187|050|H|recommended by your doctor to get the most benefit from this||
0187|051|H|medication. Your condition may not get better for 1 to 3 months||
0187|052|H|and may actually get worse when you start this medication. Tell||
0187|053|H|your doctor if your condition continues to get worse after a||
0187|054|H|month of treatment.||
0187|055|H|   For the treatment of cystinuria, follow the diet recommended||
0187|056|H|by your doctor to get the most benefit from this medication.||
0187|057|H|Drink plenty of water unless your doctor directs you otherwise.||
0187|058|H|   Tell your doctor if your condition does not get better or if||
0187|059|H|it gets worse.||
0187|060|B|||
0187|061|S|SIDE EFFECTS:  Stomach/abdominal pain, nausea/vomiting, loss of||
0187|062|S|appetite, diarrhea, and decreased sense of taste may occur. If||
0187|063|S|any of these effects last or get worse, tell your doctor or||
0187|064|S|pharmacist promptly.||
0187|065|S|   Remember that this medication has been prescribed because your||
0187|066|S|doctor has judged that the benefit to you is greater than the||
0187|067|S|risk of side effects. Many people using this medication do not||
0187|068|S|have serious side effects.||
0187|069|S|   Tell your doctor right away if you have any serious side||
0187|070|S|effects, including: signs of infection (such as sore throat that||
0187|071|S|doesn't go away, fever, chills, swollen lymph nodes), easy||
0187|072|S|bruising/bleeding, coughing up blood, shortness of breath,||
0187|073|S|unusual tiredness, rapid breathing, skin blisters, mouth sores,||
0187|074|S|new or worsening joint pain, thinning/wrinkling skin, signs of||
0187|075|S|kidney problems (such as change in the amount of urine, bloody||
0187|076|S|urine), muscle weakness, eye problems (such as drooping eyelids,||
0187|077|S|blurred vision), signs of liver problems (such as nausea/vomiting||
0187|078|S|that doesn't stop, severe stomach/abdominal pain, dark urine,||
0187|079|S|yellowing eyes/skin).||
0187|080|S|   A very serious allergic reaction to this drug is rare.||
0187|081|S|However, get medical help right away if you notice any symptoms||
0187|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0187|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0187|084|S|breathing.||
0187|085|S|   This is not a complete list of possible side effects. If you||
0187|086|S|notice other effects not listed above, contact your doctor or||
0187|087|S|pharmacist.||
0187|088|S|   In the US -||
0187|089|S|   Call your doctor for medical advice about side effects. You||
0187|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0187|091|S|www.fda.gov/medwatch.||
0187|092|S|   In Canada - Call your doctor for medical advice about side||
0187|093|S|effects. You may report side effects to Health Canada at||
0187|094|S|1-866-234-2345.||
0187|095|B|||
0187|096|P|PRECAUTIONS:  Before taking penicillamine, tell your doctor or||
0187|097|P|pharmacist if you are allergic to it; or to penicillins; or if||
0187|098|P|you have any other allergies. This product may contain inactive||
0187|099|P|ingredients, which can cause allergic reactions or other||
0187|100|P|problems. Talk to your pharmacist for more details.||
0187|101|P|   Before using this medication, tell your doctor or pharmacist||
0187|102|P|your medical history, especially of: a previous severe reaction||
0187|103|P|to penicillamine (such as aplastic anemia, agranulocytosis),||
0187|104|P|kidney disease, blood/bone marrow disorders (such as||
0187|105|P|thrombocytopenia).||
0187|106|P|   Before having surgery, tell your doctor or dentist about all||
0187|107|P|the products you use (including prescription drugs,||
0187|108|P|nonprescription drugs, and herbal products).||
0187|109|P|   Tell your doctor if you are pregnant or plan to become||
0187|110|P|pregnant. You should not become pregnant while using||
0187|111|P|penicillamine. Penicillamine may harm an unborn baby. However, it||
0187|112|P|may sometimes be used during pregnancy in certain situations||
0187|113|P|(such as treating Wilson's disease). If you become pregnant, talk||
0187|114|P|to your doctor right away about the risks and benefits of this||
0187|115|P|medication.||
0187|116|P|   It is unknown if this medication passes into breast milk.||
0187|117|P|Because of the possible risk to the infant, breastfeeding is not||
0187|118|P|recommended while using this medication. Consult your doctor||
0187|119|P|before breastfeeding.||
0187|120|B|||
0187|121|I|DRUG INTERACTIONS:  See also How to Use section.||
0187|122|I|   Drug interactions may change how your medications work or||
0187|123|I|increase your risk for serious side effects. This document does||
0187|124|I|not contain all possible drug interactions. Keep a list of all||
0187|125|I|the products you use (including prescription/nonprescription||
0187|126|I|drugs and herbal products) and share it with your doctor and||
0187|127|I|pharmacist. Do not start, stop, or change the dosage of any||
0187|128|I|medicines without your doctor's approval.||
0187|129|I|   Some products that may interact with this drug include:||
0187|130|I|digoxin, gold salts (such as auranofin), drugs to treat malaria||
0187|131|I|(such as chloroquine), phenylbutazone, other drugs that decrease||
0187|132|I|bone marrow function (such as azathioprine, cancer chemotherapy,||
0187|133|I|trimethoprim/sulfamethoxazole).||
0187|134|B|||
0187|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0187|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0187|137|O|poison control center right away. US residents can call||
0187|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0187|139|B|||
0187|140|N|NOTES:  Do not share this medication with others.||
0187|141|N|   Lab and/or medical tests (such as complete blood count,||
0187|142|N|hematocrit/hemoglobin, liver function, urine test, physical exam)||
0187|143|N|should be done while you are taking this medication. Keep all||
0187|144|N|medical and lab appointments. Consult your doctor for more||
0187|145|N|details.||
0187|146|B|||
0187|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0187|148|D|remember. If it is near the time of the next dose, skip the||
0187|149|D|missed dose. Take your next dose at the regular time. Do not||
0187|150|D|double the dose to catch up.||
0187|151|B|||
0187|152|R|STORAGE:  Store at room temperature away from light and moisture.||
0187|153|R|Do not store in the bathroom. Keep all medications away from||
0187|154|R|children and pets.||
0187|155|R|   Do not flush medications down the toilet or pour them into a||
0187|156|R|drain unless instructed to do so. Properly discard this product||
0187|157|R|when it is expired or no longer needed. Consult your pharmacist||
0187|158|R|or local waste disposal company.||
0187|159|B|||
0187|160|A|Information last revised April 2025.||
0187|161|A|Copyright(c) 2025 First Databank, Inc.||
0187|162|B|||
0189|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0189|002|Z|does NOT have all possible information about this product. This||
0189|003|Z|information does not assure that this product is safe, effective,||
0189|004|Z|or appropriate for you. This information is not individual||
0189|005|Z|medical advice and does not substitute for the advice of your||
0189|006|Z|health care professional. Always ask your health care||
0189|007|Z|professional for complete information about this product and your||
0189|008|Z|specific health needs.||
0189|009|B|||
0189|010|T|CAPSAICIN - TOPICAL||
0189|011|F|(kap-SAY-i-sin)||
0189|012|B|||
0189|013|C|COMMON BRAND NAME(S): Capsagel, Salonpas-Hot, Zostrix||
0189|014|B|||
0189|015|U|USES:  This medication is used to treat minor aches and pains of||
0189|016|U|the muscles/joints (such as arthritis, backache, sprains).||
0189|017|U|Capsaicin works by decreasing a certain natural substance in your||
0189|018|U|body (substance P) that helps pass pain signals to the brain.||
0189|019|B|||
0189|020|V|OTHER USES:  This section contains uses of this drug that are not||
0189|021|V|listed in the approved professional labeling for the drug but||
0189|022|V|that may be prescribed by your health care professional. Use this||
0189|023|V|drug for a condition that is listed in this section only if it||
0189|024|V|has been so prescribed by your health care professional.||
0189|025|V|   This drug may also be used for nerve pain.||
0189|026|B|||
0189|027|H|HOW TO USE:  Use this medication on the skin only. Follow all||
0189|028|H|directions on the product package. If you have any questions, ask||
0189|029|H|your doctor or pharmacist.||
0189|030|H|   For the cream, gel, and lotion forms, apply a thin layer of||
0189|031|H|medication to the affected area and rub in gently and thoroughly.||
0189|032|H|You may want to use a cotton ball/swab or latex glove to apply||
0189|033|H|the medication to avoid touching the medication with your hands.||
0189|034|H|   If you are using the patch, peel off the protective covering||
0189|035|H|and place the patch to cover the painful area. The patch is||
0189|036|H|usually changed every 8 hours. Carefully follow the directions on||
0189|037|H|your product package. Fold the used patch in half with the sticky||
0189|038|H|sides together and discard out of reach of children and pets.||
0189|039|H|   Do not apply the medication in the eyes, mouth, nostrils, or||
0189|040|H|genitals. If you do get the medication in those areas, flush with||
0189|041|H|plenty of water. Also, do not apply this medication to skin that||
0189|042|H|is injured or irritated (for example, cut, scraped, sunburned).||
0189|043|H|   Do not apply this medication immediately before or after||
0189|044|H|activities such as bathing, swimming, sun bathing, or heavy||
0189|045|H|exercise. Do not bandage or wrap the affected area or use a||
0189|046|H|heating pad on that area. Doing so may increase the risk of side||
0189|047|H|effects.||
0189|048|H|   After applying the medication, wash your hands unless you are||
0189|049|H|using this medication to treat the hands. If treating the hands,||
0189|050|H|wait at least 30 minutes after applying the medication to wash||
0189|051|H|your hands.||
0189|052|H|   Use this medication regularly to get the most benefit from it.||
0189|053|H|To help you remember, use it at the same times each day.||
0189|054|H|   This medication may sometimes take up to 2 months to work.||
0189|055|H|Tell your doctor if your condition lasts for more than 7 days, if||
0189|056|H|it gets worse, or if it keeps returning. If you think you may||
0189|057|H|have a serious medical problem, get medical help right away.||
0189|058|B|||
0189|059|S|SIDE EFFECTS:  Warmth, stinging, or burning on the application||
0189|060|S|site may occur. If any of these effects last or get worse,||
0189|061|S|contact your doctor or pharmacist promptly.||
0189|062|S|   Coughing, sneezing, watery eyes, or throat irritation may||
0189|063|S|occur if you breathe in the dried residue from the medication.||
0189|064|S|Use caution to avoid inhaling the residue.||
0189|065|S|   If your doctor has directed you to use this medication,||
0189|066|S|remember that your doctor has judged that the benefit to you is||
0189|067|S|greater than the risk of side effects. Many people using this||
0189|068|S|medication do not have serious side effects.||
0189|069|S|   Stop using this medication and tell your doctor right away if||
0189|070|S|you have any serious side effects, including: blistering/swelling||
0189|071|S|at the application site, increased/unusual pain at the||
0189|072|S|application site.||
0189|073|S|   A very serious allergic reaction to this drug is rare.||
0189|074|S|However, get medical help right away if you notice any symptoms||
0189|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0189|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0189|077|S|breathing.||
0189|078|S|   This is not a complete list of possible side effects. If you||
0189|079|S|notice other effects not listed above, contact your doctor or||
0189|080|S|pharmacist.||
0189|081|S|   In the US -||
0189|082|S|   Call your doctor for medical advice about side effects. You||
0189|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0189|084|S|www.fda.gov/medwatch.||
0189|085|S|   In Canada - Call your doctor for medical advice about side||
0189|086|S|effects. You may report side effects to Health Canada at||
0189|087|S|1-866-234-2345.||
0189|088|B|||
0189|089|P|PRECAUTIONS:  Before using capsaicin, tell your doctor or||
0189|090|P|pharmacist if you are allergic to it; or to zucapsaicin; or to||
0189|091|P|hot peppers (from the Capsicum family); or to lidocaine or other||
0189|092|P|local anesthetics that may be in your brand; or if you have any||
0189|093|P|other allergies. This product may contain inactive ingredients,||
0189|094|P|which can cause allergic reactions or other problems. Talk to||
0189|095|P|your pharmacist for more details.||
0189|096|P|   If you have any health problems, consult your doctor or||
0189|097|P|pharmacist before using this medication.||
0189|098|P|   Before having surgery, tell your doctor or dentist about all||
0189|099|P|the products you use (including prescription drugs,||
0189|100|P|nonprescription drugs, and herbal products).||
0189|101|P|   If you are going to have an MRI test, tell testing personnel||
0189|102|P|if you are using the patch. Some patches may contain metals that||
0189|103|P|can cause serious burns during an MRI. Ask your doctor whether||
0189|104|P|you will need to remove your patch before the test and apply a||
0189|105|P|new patch afterward, and how to do so properly.||
0189|106|P|   During pregnancy, this medication should be used only when||
0189|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
0189|108|P|   It is unknown if this medication passes into breast milk.||
0189|109|P|Consult your doctor before breastfeeding.||
0189|110|B|||
0189|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0189|112|I|medications work or increase your risk for serious side effects.||
0189|113|I|This document does not contain all possible drug interactions.||
0189|114|I|Keep a list of all the products you use (including||
0189|115|I|prescription/nonprescription drugs and herbal products) and share||
0189|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
0189|117|I|the dosage of any medicines without your doctor's approval.||
0189|118|I|   Capsaicin is very similar to zucapsaicin. Do not use||
0189|119|I|medications containing zucapsaicin while using capsaicin.||
0189|120|B|||
0189|121|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0189|122|O|has overdosed and has serious symptoms such as passing out or||
0189|123|O|trouble breathing, call 911. Otherwise, call a poison control||
0189|124|O|center right away. US residents can call 1-800-222-1222. Canada||
0189|125|O|residents can call 1-844-764-7669.||
0189|126|B|||
0189|127|N|NOTES:  Keep all medical and lab appointments.||
0189|128|B|||
0189|129|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0189|130|D|If it is near the time of the next dose, skip the missed dose.||
0189|131|D|Use your next dose at the regular time. Do not double the dose to||
0189|132|D|catch up.||
0189|133|B|||
0189|134|R|STORAGE:  Refer to storage information printed on the package. If||
0189|135|R|you have any questions about storage, ask your pharmacist. Keep||
0189|136|R|all medications away from children and pets.||
0189|137|R|   Do not flush medications down the toilet or pour them into a||
0189|138|R|drain unless instructed to do so. Properly discard this product||
0189|139|R|when it is expired or no longer needed. Consult your pharmacist||
0189|140|R|or local waste disposal company.||
0189|141|B|||
0189|142|A|Information last revised February 2025.||
0189|143|A|Copyright(c) 2025 First Databank, Inc.||
0189|144|B|||
0190|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0190|002|Z|does NOT have all possible information about this product. This||
0190|003|Z|information does not assure that this product is safe, effective,||
0190|004|Z|or appropriate for you. This information is not individual||
0190|005|Z|medical advice and does not substitute for the advice of your||
0190|006|Z|health care professional. Always ask your health care||
0190|007|Z|professional for complete information about this product and your||
0190|008|Z|specific health needs.||
0190|009|B|||
0190|010|T|NALTREXONE - ORAL||
0190|011|F|(nal-TREX-one)||
0190|012|B|||
0190|013|C|COMMON BRAND NAME(S): Revia||
0190|014|B|||
0190|015|U|USES:  This medication is used to prevent people who have been||
0190|016|U|addicted to certain drugs (opiates) from taking them again. It is||
0190|017|U|used as part of a complete treatment program for drug abuse (such||
0190|018|U|as compliance monitoring, counseling, behavioral contract,||
0190|019|U|lifestyle changes). This medication must not be used in people||
0190|020|U|currently taking opiates, including methadone. Doing so can cause||
0190|021|U|sudden withdrawal symptoms.||
0190|022|U|   Naltrexone belongs to a class of drugs known as opiate||
0190|023|U|antagonists. It works in the brain to prevent opiate effects||
0190|024|U|(such as feelings of well-being, pain relief). It also decreases||
0190|025|U|the desire to take opiates.||
0190|026|U|   Ask your doctor or pharmacist if you should have medication||
0190|027|U|available to treat opioid overdose (such as naloxone, nalmefene).||
0190|028|U|Teach your family or household members about the signs of an||
0190|029|U|opioid overdose and how to treat it.||
0190|030|U|   This medication is also used to treat alcohol abuse. It can||
0190|031|U|help people drink less alcohol or stop drinking altogether. It||
0190|032|U|also decreases the desire to drink alcohol when used with a||
0190|033|U|treatment program that includes counseling, support, and||
0190|034|U|lifestyle changes.||
0190|035|B|||
0190|036|H|HOW TO USE:  Take this medication by mouth with or without food||
0190|037|H|as directed by your doctor, usually once daily. This medication||
0190|038|H|may be given as part of a program where a health care||
0190|039|H|professional will watch you take the medication. In this case,||
0190|040|H|this medication may be taken every 2 to 3 days to make it easier||
0190|041|H|to schedule clinic visits. Naltrexone may be taken with food or||
0190|042|H|antacids if stomach upset occurs.||
0190|043|H|   A urine test should be done to check for recent opiate drug||
0190|044|H|use. Your doctor may give you another medication (naloxone||
0190|045|H|challenge test) to check for opiate use. Do not use any opiates||
0190|046|H|for at least 7 days before starting naltrexone. You may need to||
0190|047|H|stop certain opiate drugs (such as methadone) 10 to 14 days||
0190|048|H|before starting naltrexone.||
0190|049|H|   The dosage is based on your medical condition and response to||
0190|050|H|treatment. Your doctor may start you at a lower dose and monitor||
0190|051|H|you for any side effects or withdrawal symptoms before increasing||
0190|052|H|your dose. Take this medication as directed. Do not increase your||
0190|053|H|dose, take it more often, or stop taking it without your doctor's||
0190|054|H|approval.||
0190|055|H|   Use this medication regularly to get the most benefit from it.||
0190|056|H|To help you remember, take it at the same time each day.||
0190|057|H|   Tell your doctor if you start using drugs (opiates) or alcohol||
0190|058|H|again.||
0190|059|B|||
0190|060|S|SIDE EFFECTS:  Nausea, headache, dizziness, anxiety, tiredness,||
0190|061|S|and trouble sleeping may occur. In a small number of people, mild||
0190|062|S|opiate withdrawal symptoms may occur, including abdominal cramps,||
0190|063|S|restlessness, bone/joint pain, muscle aches, and runny nose. If||
0190|064|S|any of these effects last or get worse, tell your doctor or||
0190|065|S|pharmacist promptly.||
0190|066|S|   Remember that this medication has been prescribed because your||
0190|067|S|doctor has judged that the benefit to you is greater than the||
0190|068|S|risk of side effects. Many people using this medication do not||
0190|069|S|have serious side effects.||
0190|070|S|   Sudden opiate withdrawal symptoms can occur within minutes||
0190|071|S|after taking naltrexone. Tell your doctor right away if any||
0190|072|S|withdrawal symptoms occur, including: abdominal cramps,||
0190|073|S|nausea/vomiting, diarrhea, joint/bone/muscle aches, mental/mood||
0190|074|S|changes (such as anxiety, confusion, extreme sleepiness, visual||
0190|075|S|hallucinations), runny nose.||
0190|076|S|   Naltrexone has rarely caused serious liver disease. The risk||
0190|077|S|is increased when larger doses are used. Discuss the risks and||
0190|078|S|benefits with your doctor. Tell your doctor right away if you||
0190|079|S|develop symptoms of liver disease, including: nausea/vomiting||
0190|080|S|that doesn't stop, severe stomach/abdominal pain, dark urine,||
0190|081|S|yellowing eyes/skin.||
0190|082|S|   A very serious allergic reaction to this drug is rare.||
0190|083|S|However, get medical help right away if you notice any symptoms||
0190|084|S|of a serious allergic reaction, including: rash, itching/swelling||
0190|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0190|086|S|breathing.||
0190|087|S|   This is not a complete list of possible side effects. If you||
0190|088|S|notice other effects not listed above, contact your doctor or||
0190|089|S|pharmacist.||
0190|090|S|   In the US -||
0190|091|S|   Call your doctor for medical advice about side effects. You||
0190|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0190|093|S|www.fda.gov/medwatch.||
0190|094|S|   In Canada - Call your doctor for medical advice about side||
0190|095|S|effects. You may report side effects to Health Canada at||
0190|096|S|1-866-234-2345.||
0190|097|B|||
0190|098|P|PRECAUTIONS:  Before taking naltrexone, tell your doctor or||
0190|099|P|pharmacist if you are allergic to it; or if you have any other||
0190|100|P|allergies. This product may contain inactive ingredients, which||
0190|101|P|can cause allergic reactions or other problems. Talk to your||
0190|102|P|pharmacist for more details.||
0190|103|P|   Before using this medication, tell your doctor or pharmacist||
0190|104|P|your medical history, especially of: current or recent use (in||
0190|105|P|the last 7 to 14 days) of any type of opioid drug (such as||
0190|106|P|morphine, methadone, buprenorphine), kidney disease, liver||
0190|107|P|disease.||
0190|108|P|   You should carry or wear medical identification stating that||
0190|109|P|you are taking this drug so that appropriate treatment can be||
0190|110|P|given in a medical emergency.||
0190|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0190|112|P|can make you more dizzy. Do not drive, use machinery, or do||
0190|113|P|anything that needs alertness until you can do it safely. Avoid||
0190|114|P|alcoholic beverages. Talk to your doctor if you are using||
0190|115|P|marijuana (cannabis).||
0190|116|P|   After stopping naltrexone treatment, you may be more sensitive||
0190|117|P|to lower doses of opioids, increasing your risk of possibly||
0190|118|P|life-threatening side effects from the opioid (such as decreased||
0190|119|P|breathing, loss of consciousness).||
0190|120|P|   This medication blocks the effects of opiate drugs (including||
0190|121|P|heroin) and similar drugs (opioids). However, large doses of||
0190|122|P|heroin or opioids can overcome this block. Trying to overcome||
0190|123|P|this block is very dangerous and may cause serious injury, loss||
0190|124|P|of consciousness, and death. Make sure you completely understand||
0190|125|P|and accept the risks and benefits of using this medication.||
0190|126|P|Follow your doctor's instructions closely.||
0190|127|P|   Before having surgery, tell your doctor or dentist about all||
0190|128|P|the products you use (including prescription drugs,||
0190|129|P|nonprescription drugs, and herbal products).||
0190|130|P|   During pregnancy, this medication should be used only when||
0190|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
0190|132|P|   This drug passes into breast milk. Consult your doctor before||
0190|133|P|breastfeeding.||
0190|134|B|||
0190|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0190|136|I|medications work or increase your risk for serious side effects.||
0190|137|I|This document does not contain all possible drug interactions.||
0190|138|I|Keep a list of all the products you use (including||
0190|139|I|prescription/nonprescription drugs and herbal products) and share||
0190|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
0190|141|I|the dosage of any medicines without your doctor's approval.||
0190|142|I|   Some products that may interact with this drug include:||
0190|143|I|dextromethorphan, diarrhea medication (such as diphenoxylate),||
0190|144|I|disulfiram, opioid pain or cough relievers (such as codeine,||
0190|145|I|hydrocodone), thioridazine.||
0190|146|I|   This medication may interfere with certain lab tests (such as||
0190|147|I|drug tests), possibly causing false test results. Make sure lab||
0190|148|I|personnel and all your doctors know you use this drug.||
0190|149|B|||
0190|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0190|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0190|152|O|poison control center right away. US residents can call||
0190|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0190|154|B|||
0190|155|N|NOTES:  Do not share this medication with others.||
0190|156|N|   Lab and/or medical tests (such as liver function) should be||
0190|157|N|done while you are taking this medication. Keep all medical and||
0190|158|N|lab appointments. Consult your doctor for more details.||
0190|159|B|||
0190|160|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0190|161|D|remember. If it is near the time of the next dose, skip the||
0190|162|D|missed dose. Take your next dose at the regular time. Do not||
0190|163|D|double the dose to catch up.||
0190|164|B|||
0190|165|R|STORAGE:  Store at room temperature away from light and moisture.||
0190|166|R|Do not store in the bathroom. Keep all medications away from||
0190|167|R|children and pets.||
0190|168|R|   Do not flush medications down the toilet or pour them into a||
0190|169|R|drain unless instructed to do so. Properly discard this product||
0190|170|R|when it is expired or no longer needed. Consult your pharmacist||
0190|171|R|or local waste disposal company.||
0190|172|B|||
0190|173|A|Information last revised August 2025.||
0190|174|A|Copyright(c) 2025 First Databank, Inc.||
0190|175|B|||
0191|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0191|002|Z|does NOT have all possible information about this product. This||
0191|003|Z|information does not assure that this product is safe, effective,||
0191|004|Z|or appropriate for you. This information is not individual||
0191|005|Z|medical advice and does not substitute for the advice of your||
0191|006|Z|health care professional. Always ask your health care||
0191|007|Z|professional for complete information about this product and your||
0191|008|Z|specific health needs.||
0191|009|B|||
0191|010|T|PENTOXIFYLLINE SUSTAINED-ACTION - ORAL||
0191|011|F|(PEN-tox-IF-i-lin)||
0191|012|B|||
0191|013|C|COMMON BRAND NAME(S): Trental||
0191|014|B|||
0191|015|U|USES:  This medication is used to improve the symptoms of a||
0191|016|U|certain blood flow problem in the legs/arms (intermittent||
0191|017|U|claudication due to occlusive artery disease). Pentoxifylline can||
0191|018|U|decrease the muscle aching/pain/cramps during exercise, including||
0191|019|U|walking, that occur with intermittent claudication.||
0191|020|U|Pentoxifylline belongs to a class of drugs known as||
0191|021|U|hemorrheologic agents. It works by helping blood flow more easily||
0191|022|U|through narrowed arteries. This increases the amount of oxygen||
0191|023|U|that can be delivered by the blood when the muscles need more||
0191|024|U|(such as during exercise) thereby increasing walking distance and||
0191|025|U|duration.||
0191|026|B|||
0191|027|H|HOW TO USE:  Take this medication by mouth with food as directed||
0191|028|H|by your doctor, usually 3 times daily.||
0191|029|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
0191|030|H|Doing so can release all of the drug at once, increasing the risk||
0191|031|H|of side effects.||
0191|032|H|   Dosage is based on your medical condition and response to||
0191|033|H|treatment.||
0191|034|H|   Use this medication regularly in order to get the most benefit||
0191|035|H|from it. To help you remember, take it at the same times each||
0191|036|H|day. Keep taking this medication even if you feel well. Do not||
0191|037|H|stop this medication without consulting your doctor. Improvement||
0191|038|H|in symptoms can occur in 2-4 weeks, but it may take up to 8 weeks||
0191|039|H|to get the full benefit.||
0191|040|H|   Tell your doctor if your condition lasts or gets worse.||
0191|041|B|||
0191|042|S|SIDE EFFECTS:  Nausea, vomiting, gas, belching, and dizziness may||
0191|043|S|occur. If any of these effects last or get worse, tell your||
0191|044|S|doctor or pharmacist promptly.||
0191|045|S|   Remember that this medication has been prescribed because your||
0191|046|S|doctor has judged that the benefit to you is greater than the||
0191|047|S|risk of side effects. Many people using this medication do not||
0191|048|S|have serious side effects.||
0191|049|S|   Tell your doctor right away if you have any serious side||
0191|050|S|effects, including: fast/irregular heartbeat, easy||
0191|051|S|bruising/bleeding.||
0191|052|S|   Get medical help right away if you have any very serious side||
0191|053|S|effects, including: chest pain.||
0191|054|S|   A very serious allergic reaction to this drug is rare.||
0191|055|S|However, get medical help right away if you notice any symptoms||
0191|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0191|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0191|058|S|breathing.||
0191|059|S|   This is not a complete list of possible side effects. If you||
0191|060|S|notice other effects not listed above, contact your doctor or||
0191|061|S|pharmacist.||
0191|062|S|   In the US -||
0191|063|S|   Call your doctor for medical advice about side effects. You||
0191|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0191|065|S|www.fda.gov/medwatch.||
0191|066|S|   In Canada - Call your doctor for medical advice about side||
0191|067|S|effects. You may report side effects to Health Canada at||
0191|068|S|1-866-234-2345.||
0191|069|B|||
0191|070|P|PRECAUTIONS:  Before taking pentoxifylline, tell your doctor or||
0191|071|P|pharmacist if you are allergic to it; or to caffeine, or||
0191|072|P|theophylline; or if you have any other allergies. This product||
0191|073|P|may contain inactive ingredients, which can cause allergic||
0191|074|P|reactions or other problems. Talk to your pharmacist for more||
0191|075|P|details.||
0191|076|P|   Before using this medication, tell your doctor or pharmacist||
0191|077|P|your medical history, especially of: recent stroke, recent||
0191|078|P|bleeding in the eye, kidney problems, liver problems, recent||
0191|079|P|major surgery, stomach ulcer.||
0191|080|P|   This drug may rarely make you dizzy. Alcohol or marijuana||
0191|081|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
0191|082|P|or do anything that needs alertness until you can do it safely.||
0191|083|P|Limit alcoholic beverages. Talk to your doctor if you are using||
0191|084|P|marijuana (cannabis).||
0191|085|P|   Before having surgery, tell your doctor or dentist about all||
0191|086|P|the products you use (including prescription drugs,||
0191|087|P|nonprescription drugs, and herbal products).||
0191|088|P|   During pregnancy, this medication should be used only when||
0191|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
0191|090|P|   This medication passes into breast milk. Consult your doctor||
0191|091|P|before breastfeeding.||
0191|092|B|||
0191|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0191|094|I|medications work or increase your risk for serious side effects.||
0191|095|I|This document does not contain all possible drug interactions.||
0191|096|I|Keep a list of all the products you use (including||
0191|097|I|prescription/nonprescription drugs and herbal products) and share||
0191|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
0191|099|I|the dosage of any medicines without your doctor's approval.||
0191|100|I|   Some products that may interact with this drug include: other||
0191|101|I|drugs that can cause bleeding/bruising (including antiplatelet||
0191|102|I|drugs such as clopidogrel, NSAIDs such as||
0191|103|I|ibuprofen/ketorolac/naproxen, "blood thinners" such as||
0191|104|I|warfarin/dabigatran).||
0191|105|I|   Aspirin can increase the risk of bleeding when used with this||
0191|106|I|medication. However, if your doctor has told you to take low-dose||
0191|107|I|aspirin to prevent heart attack or stroke (usually 81-162||
0191|108|I|milligrams a day), you should keep taking the aspirin unless your||
0191|109|I|doctor tells you not to.||
0191|110|B|||
0191|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0191|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0191|113|O|poison control center right away. US residents can call||
0191|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0191|115|O|Symptoms of overdose may include: flushing, severe dizziness,||
0191|116|O|seizures, drowsiness, loss of consciousness, fever, agitation.||
0191|117|B|||
0191|118|N|NOTES:  Do not share this medication with others.||
0191|119|N|   Lab and/or medical tests (such as blood counts, blood||
0191|120|N|pressure) should be done while you are taking this medication.||
0191|121|N|Keep all medical and lab appointments. Consult your doctor for||
0191|122|N|more details.||
0191|123|N|   Lifestyle changes that may help reduce the symptoms of||
0191|124|N|intermittent claudication include stopping smoking, exercising||
0191|125|N|regularly, and losing weight. Ask your doctor about lifestyle||
0191|126|N|changes that may benefit you.||
0191|127|B|||
0191|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0191|129|D|remember. If it is near the time of the next dose, skip the||
0191|130|D|missed dose. Take your next dose at the regular time. Do not||
0191|131|D|double the dose to catch up.||
0191|132|B|||
0191|133|R|STORAGE:  Store at room temperature away from light and moisture.||
0191|134|R|Do not store in the bathroom. Keep all medications away from||
0191|135|R|children and pets.||
0191|136|R|   Do not flush medications down the toilet or pour them into a||
0191|137|R|drain unless instructed to do so. Properly discard this product||
0191|138|R|when it is expired or no longer needed. Consult your pharmacist||
0191|139|R|or local waste disposal company.||
0191|140|B|||
0191|141|A|Information last revised May 2024.||
0191|142|A|Copyright(c) 2025 First Databank, Inc.||
0191|143|B|||
0193|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0193|002|Z|does NOT have all possible information about this product. This||
0193|003|Z|information does not assure that this product is safe, effective,||
0193|004|Z|or appropriate for you. This information is not individual||
0193|005|Z|medical advice and does not substitute for the advice of your||
0193|006|Z|health care professional. Always ask your health care||
0193|007|Z|professional for complete information about this product and your||
0193|008|Z|specific health needs.||
0193|009|B|||
0193|010|T|SALICYLIC ACID (FOR ACNE) - TOPICAL||
0193|011|F|(SAL-i-SIL-ik AS-id)||
0193|012|B|||
0193|013|U|USES:  This product is used to treat mild to moderate acne. It||
0193|014|U|may be used in combination with other acne treatments. Check with||
0193|015|U|your doctor or pharmacist first before combining acne treatments.||
0193|016|U|Salicylic acid belongs to a class of drugs known as salicylates.||
0193|017|U|When applied to the skin, salicylic acid may work by helping the||
0193|018|U|skin to shed dead cells from the top layer and by decreasing||
0193|019|U|redness and swelling (inflammation). This decreases the number of||
0193|020|U|pimples that form and speeds healing.||
0193|021|B|||
0193|022|H|HOW TO USE:  Follow all directions on the product package. If you||
0193|023|H|have any questions, ask your doctor or pharmacist.||
0193|024|H|   Before using this product for the first time, check if you are||
0193|025|H|allergic to it. To check, put a small amount on one or two small||
0193|026|H|areas of acne for three days. If you have an allergic reaction,||
0193|027|H|stop using this product and get medical help right away (see the||
0193|028|H|symptoms of an allergic reaction in the Side Effects section). If||
0193|029|H|you don't have an allergic reaction, you can use the product.||
0193|030|H|   This medication is for use on the skin only. To avoid||
0193|031|H|irritation, do not let this medication come into contact with||
0193|032|H|your eyes, nose, mouth, groin, or any broken skin (such as cuts,||
0193|033|H|scrapes, rashes). If you do get the medication in those areas,||
0193|034|H|flush the area with cool water for 15 minutes.||
0193|035|H|   Before applying each dose, gently wash the affected area with||
0193|036|H|a mild cleanser, then pat dry. Apply a thin layer of medication||
0193|037|H|to the skin affected by acne and rub in gently. Wash hands after||
0193|038|H|use. If tolerated, reapply the medication several times a day as||
0193|039|H|directed on the product packaging, or as directed by your doctor.||
0193|040|H|   If using cleansers containing salicylic acid, wet the affected||
0193|041|H|area. Gently rub the cleanser into the skin for 10 to 20 seconds,||
0193|042|H|or as directed. Do not scrub the skin. Work into a full lather||
0193|043|H|and rinse thoroughly, and then pat dry. If too much drying||
0193|044|H|occurs, you may need to rinse the cleanser off sooner or use it||
0193|045|H|less often. Consult your doctor or pharmacist for further||
0193|046|H|details.||
0193|047|H|   Dosage is based on your medical condition and response to||
0193|048|H|treatment. Do not use large amounts, apply this drug more often,||
0193|049|H|or use it for a longer period than directed. Your condition will||
0193|050|H|not clear faster, but the chance for side effects may be||
0193|051|H|increased.||
0193|052|H|   If your condition lasts or gets worse, or if you think you may||
0193|053|H|have a serious medical problem, get medical help right away.||
0193|054|B|||
0193|055|S|SIDE EFFECTS:  Skin reactions such as||
0193|056|S|peeling/burning/dry/reddened skin may occur, especially at the||
0193|057|S|start of treatment. If any of these effects last or get worse,||
0193|058|S|tell your doctor or pharmacist promptly. You may need to apply||
0193|059|S|smaller amounts of the drug or use it less often. Consult your||
0193|060|S|doctor or pharmacist for more details.||
0193|061|S|   If your doctor has directed you to use this medication,||
0193|062|S|remember that your doctor has judged that the benefit to you is||
0193|063|S|greater than the risk of side effects. Many people using this||
0193|064|S|medication do not have serious side effects.||
0193|065|S|   A very serious allergic reaction to this drug is rare.||
0193|066|S|However, get medical help right away if you notice any symptoms||
0193|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0193|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0193|069|S|breathing.||
0193|070|S|   This is not a complete list of possible side effects. If you||
0193|071|S|notice other effects not listed above, contact your doctor or||
0193|072|S|pharmacist.||
0193|073|S|   In the US -||
0193|074|S|   Call your doctor for medical advice about side effects. You||
0193|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0193|076|S|www.fda.gov/medwatch.||
0193|077|S|   In Canada - Call your doctor for medical advice about side||
0193|078|S|effects. You may report side effects to Health Canada at||
0193|079|S|1-866-234-2345.||
0193|080|B|||
0193|081|P|PRECAUTIONS:  Before using salicylic acid, tell your doctor or||
0193|082|P|pharmacist if you are allergic to it; or to nonsteroidal||
0193|083|P|anti-inflammatory drugs-NSAIDs (such as aspirin, ibuprofen,||
0193|084|P|naproxen); or if you have any other allergies. This product may||
0193|085|P|contain inactive ingredients, which can cause allergic reactions||
0193|086|P|or other problems. Talk to your pharmacist for more details.||
0193|087|P|   If you have any of the following health problems, consult your||
0193|088|P|doctor or pharmacist before using this product: diabetes, poor||
0193|089|P|circulation, skin problems (such as infection, wounds, atopic||
0193|090|P|dermatitis).||
0193|091|P|   During pregnancy, this product should be used only when||
0193|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
0193|093|P|   It is unknown if this medication passes into breast milk.||
0193|094|P|Consult your doctor before breastfeeding.||
0193|095|B|||
0193|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0193|097|I|medications work or increase your risk for serious side effects.||
0193|098|I|This document does not contain all possible drug interactions.||
0193|099|I|Keep a list of all the products you use (including||
0193|100|I|prescription/nonprescription drugs and herbal products) and share||
0193|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0193|102|I|the dosage of any medicines without your doctor's approval.||
0193|103|B|||
0193|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0193|105|O|has overdosed and has serious symptoms such as passing out or||
0193|106|O|trouble breathing, call 911. Otherwise, call a poison control||
0193|107|O|center right away. US residents can call 1-800-222-1222. Canada||
0193|108|O|residents can call 1-844-764-7669.||
0193|109|B|||
0193|110|N|NOTES:  If this medication has been prescribed by your doctor, do||
0193|111|N|not share this medication with others.||
0193|112|B|||
0193|113|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0193|114|D|If it is near the time of the next dose, skip the missed dose.||
0193|115|D|Use your next dose at the regular time. Do not double the dose to||
0193|116|D|catch up.||
0193|117|B|||
0193|118|R|STORAGE:  Store at room temperature. Different brands of this||
0193|119|R|medication have different storage needs. Check the product||
0193|120|R|package for instructions on how to store your brand, or ask your||
0193|121|R|pharmacist. Keep all medications away from children and pets.||
0193|122|R|   Do not flush medications down the toilet or pour them into a||
0193|123|R|drain unless instructed to do so. Properly discard this product||
0193|124|R|when it is expired or no longer needed. Consult your pharmacist||
0193|125|R|or local waste disposal company.||
0193|126|B|||
0193|127|A|Information last revised April 2025.||
0193|128|A|Copyright(c) 2025 First Databank, Inc.||
0193|129|B|||
0196|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0196|002|Z|does NOT have all possible information about this product. This||
0196|003|Z|information does not assure that this product is safe, effective,||
0196|004|Z|or appropriate for you. This information is not individual||
0196|005|Z|medical advice and does not substitute for the advice of your||
0196|006|Z|health care professional. Always ask your health care||
0196|007|Z|professional for complete information about this product and your||
0196|008|Z|specific health needs.||
0196|009|B|||
0196|010|T|NEOMYCIN/POLYMYXIN/HYDROCORTISONE SOLUTION - OTIC||
0196|011|F|(NEE-oh-MYE-sin/POL-ee-MIX-in/HYE-droe-KOR-ti-sone)||
0196|012|B|||
0196|013|C|COMMON BRAND NAME(S): Cortisporin||
0196|014|B|||
0196|015|U|USES:  This ear drop is used to treat outer ear infections caused||
0196|016|U|by bacteria (also known as swimmer's ear). This medication||
0196|017|U|contains neomycin and polymyxin, which are antibiotics that work||
0196|018|U|by stopping the growth of bacteria. It also contains||
0196|019|U|hydrocortisone, which is an anti-inflammatory corticosteroid that||
0196|020|U|works by reducing ear swelling and discomfort.||
0196|021|U|   This medication treats only bacterial ear infections. It will||
0196|022|U|not work for other types of ear infections. Unnecessary use or||
0196|023|U|overuse of any antibiotic can lead to its decreased||
0196|024|U|effectiveness.||
0196|025|B|||
0196|026|H|HOW TO USE:  Use this medication in the infected ear as directed||
0196|027|H|by your doctor, usually 3 or 4 times a day. The ear canal should||
0196|028|H|be clean and dry before using this medication. Use in the ear||
0196|029|H|only. Do not use in the eyes.||
0196|030|H|   To make sure that the right amount of medication is given, and||
0196|031|H|to avoid touching the ear with the dropper, have another person||
0196|032|H|give the drops if possible. To lower the risk of dizziness, hold||
0196|033|H|the container in your hand for a few minutes in order to warm it.||
0196|034|H|   To apply ear drops, wash your hands first. To avoid||
0196|035|H|contamination, do not touch the dropper tip or let it touch your||
0196|036|H|ear or any other surface.||
0196|037|H|   Lie on your side with the affected ear upward. Hold the||
0196|038|H|dropper directly over the ear and place the prescribed number of||
0196|039|H|drops into the ear canal. To help the drops roll into the ear of||
0196|040|H|an adult, hold the earlobe up and back. For children, hold the||
0196|041|H|earlobe down and back. Keep the head tilted with the treated ear||
0196|042|H|upward for 5 minutes, or insert a soft cotton plug if so||
0196|043|H|directed. Another way to give this medication is to place a||
0196|044|H|cotton wick in the ear canal and moisten it with the prescribed||
0196|045|H|number of drops as often as directed. The wick should be replaced||
0196|046|H|at least once a day.||
0196|047|H|   Repeat the above steps for the other ear if so directed. Do||
0196|048|H|not rinse the dropper. Replace the cap after use.||
0196|049|H|   Use this medication regularly in order to get the most benefit||
0196|050|H|from it. To help you remember, use it at the same times each day.||
0196|051|H|Continue to use this medication for the full time prescribed,||
0196|052|H|even if symptoms disappear after a few days. Stopping the||
0196|053|H|medication too early may result in a return of the infection.||
0196|054|H|   Do not use this medication more often than prescribed or||
0196|055|H|continue to use it for longer than 10 days.||
0196|056|H|   Tell your doctor if your condition lasts or gets worse.||
0196|057|B|||
0196|058|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
0196|059|S|ear for a minute or two when applied. If these effects last or||
0196|060|S|get worse, tell your doctor or pharmacist promptly.||
0196|061|S|   Remember that this medication has been prescribed because your||
0196|062|S|doctor has judged that the benefit to you is greater than the||
0196|063|S|risk of side effects. Many people using this medication do not||
0196|064|S|have serious side effects.||
0196|065|S|   Tell your doctor right away if you have any serious side||
0196|066|S|effects, including: hearing problems (such as hearing loss).||
0196|067|S|   Use of this medication for prolonged or repeated periods may||
0196|068|S|result in a new fungal ear infection. Do not use it for longer||
0196|069|S|than prescribed. Contact your doctor if you notice new or||
0196|070|S|worsening symptoms.||
0196|071|S|   A very serious allergic reaction to this drug is rare.||
0196|072|S|However, get medical help right away if you notice any symptoms||
0196|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0196|074|S|(especially of the face/tongue/throat), redness of the ears,||
0196|075|S|severe dizziness, trouble breathing.||
0196|076|S|   This is not a complete list of possible side effects. If you||
0196|077|S|notice other effects not listed above, contact your doctor or||
0196|078|S|pharmacist.||
0196|079|S|   In the US -||
0196|080|S|   Call your doctor for medical advice about side effects. You||
0196|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0196|082|S|www.fda.gov/medwatch.||
0196|083|S|   In Canada - Call your doctor for medical advice about side||
0196|084|S|effects. You may report side effects to Health Canada at||
0196|085|S|1-866-234-2345.||
0196|086|B|||
0196|087|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0196|088|P|pharmacist if you are allergic to neomycin, polymyxin, or||
0196|089|P|hydrocortisone; or to aminoglycoside antibiotics (such as||
0196|090|P|gentamicin, tobramycin); or to corticosteroids (such as||
0196|091|P|dexamethasone, prednisone); or if you have any other allergies.||
0196|092|P|This product may contain inactive ingredients (such as sulfites),||
0196|093|P|which can cause allergic reactions or other problems. Talk to||
0196|094|P|your pharmacist for more details.||
0196|095|P|   Before using this medication, tell your doctor or pharmacist||
0196|096|P|your medical history, especially of: other ear problems (such as||
0196|097|P|a hole in your eardrum, middle ear infection), an ear infection||
0196|098|P|caused by a virus (such as herpes simplex, varicella).||
0196|099|P|   This medication should be used only if clearly needed during||
0196|100|P|pregnancy. Discuss the risks and benefits with your doctor.||
0196|101|P|   It is unknown if this medication passes into breast milk.||
0196|102|P|Consult your doctor before breastfeeding.||
0196|103|B|||
0196|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0196|105|I|medications work or increase your risk for serious side effects.||
0196|106|I|This document does not contain all possible drug interactions.||
0196|107|I|Keep a list of all the products you use (including||
0196|108|I|prescription/nonprescription drugs and herbal products) and share||
0196|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
0196|110|I|the dosage of any medicines without your doctor's approval.||
0196|111|B|||
0196|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0196|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0196|114|O|poison control center right away. US residents can call||
0196|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0196|116|O|medicine may be harmful if swallowed.||
0196|117|B|||
0196|118|N|NOTES:  Do not share this medication with others.||
0196|119|N|   This medication has been prescribed for your current condition||
0196|120|N|only. Do not use it later for another infection unless your||
0196|121|N|doctor tells you to.||
0196|122|N|   It is important to keep the infected ear(s) clean and dry. Try||
0196|123|N|not to get the infected ear(s) wet when bathing. Avoid swimming||
0196|124|N|unless your doctor tells you otherwise.||
0196|125|B|||
0196|126|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0196|127|D|If it is near the time of the next dose, skip the missed dose.||
0196|128|D|Use your next dose at the regular time. Do not double the dose to||
0196|129|D|catch up.||
0196|130|B|||
0196|131|R|STORAGE:  Store at room temperature away from light and moisture.||
0196|132|R|Keep all medications away from children and pets.||
0196|133|R|   Do not flush medications down the toilet or pour them into a||
0196|134|R|drain unless instructed to do so. Properly discard this product||
0196|135|R|when it is expired or no longer needed. Consult your pharmacist||
0196|136|R|or local waste disposal company.||
0196|137|B|||
0196|138|A|Information last revised October 2024.||
0196|139|A|Copyright(c) 2025 First Databank, Inc.||
0196|140|B|||
0199|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0199|002|Z|does NOT have all possible information about this product. This||
0199|003|Z|information does not assure that this product is safe, effective,||
0199|004|Z|or appropriate for you. This information is not individual||
0199|005|Z|medical advice and does not substitute for the advice of your||
0199|006|Z|health care professional. Always ask your health care||
0199|007|Z|professional for complete information about this product and your||
0199|008|Z|specific health needs.||
0199|009|B|||
0199|010|T|AMINOCAPROIC ACID - ORAL||
0199|011|F|(a-MEE-noe-ka-PROE-ik AS-id)||
0199|012|B|||
0199|013|C|COMMON BRAND NAME(S): Amicar||
0199|014|B|||
0199|015|U|USES:  This medication is used to help control bleeding due to a||
0199|016|U|condition where your blood does not clot the way it normally||
0199|017|U|should (fibrinolysis). This may cause serious bleeding after||
0199|018|U|certain surgeries or in certain conditions (such as bleeding||
0199|019|U|disorders, liver disease, cancer). Aminocaproic acid works by||
0199|020|U|helping your blood clot normally. It belongs to a class of drugs||
0199|021|U|known as antifibrinolytics.||
0199|022|B|||
0199|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
0199|024|H|doctor. Follow your doctor's instructions carefully. The dosage||
0199|025|H|and how often you take this medication are based on your medical||
0199|026|H|condition and response to treatment.||
0199|027|H|   Your doctor should closely monitor you until your bleeding is||
0199|028|H|controlled. See also Notes section.||
0199|029|H|   It is very important to take this medication as prescribed by||
0199|030|H|your doctor to get the most benefit from it. Do not skip any||
0199|031|H|doses. Do not increase your dose or use this drug more often or||
0199|032|H|for longer than prescribed. Your condition will not improve any||
0199|033|H|faster, and your risk of side effects will increase.||
0199|034|H|   If you are using the liquid form of this medication, carefully||
0199|035|H|measure the dose using a special measuring device/spoon. Do not||
0199|036|H|use a household spoon because you may not get the correct dose.||
0199|037|H|   Tell your doctor if your condition lasts or gets worse.||
0199|038|B|||
0199|039|S|SIDE EFFECTS:  Headache, stomach pain, loss of appetite, nausea,||
0199|040|S|vomiting, diarrhea, unusual tiredness, dizziness, stuffy nose, or||
0199|041|S|watery eyes may occur. If any of these effects last or get worse,||
0199|042|S|tell your doctor or pharmacist promptly.||
0199|043|S|   Remember that this medication has been prescribed because your||
0199|044|S|doctor has judged that the benefit to you is greater than the||
0199|045|S|risk of side effects. Many people using this medication do not||
0199|046|S|have serious side effects.||
0199|047|S|   Tell your doctor right away if you have any serious side||
0199|048|S|effects, including: sore throat that doesn't go away, ringing in||
0199|049|S|the ears, vision changes, muscle pain/weakness, signs of kidney||
0199|050|S|problems (such as change in the amount of urine), confusion, slow||
0199|051|S|heartbeat, unusual bleeding or bruising.||
0199|052|S|   Get medical help right away if you have any very serious side||
0199|053|S|effects, including: chest pain, shortness of breath, seizures.||
0199|054|S|   A very serious allergic reaction to this drug is rare.||
0199|055|S|However, get medical help right away if you notice any symptoms||
0199|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0199|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0199|058|S|breathing.||
0199|059|S|   This is not a complete list of possible side effects. If you||
0199|060|S|notice other effects not listed above, contact your doctor or||
0199|061|S|pharmacist.||
0199|062|S|   In the US -||
0199|063|S|   Call your doctor for medical advice about side effects. You||
0199|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0199|065|S|www.fda.gov/medwatch.||
0199|066|S|   In Canada - Call your doctor for medical advice about side||
0199|067|S|effects. You may report side effects to Health Canada at||
0199|068|S|1-866-234-2345.||
0199|069|B|||
0199|070|P|PRECAUTIONS:  Before taking aminocaproic acid, tell your doctor||
0199|071|P|or pharmacist if you are allergic to it; or if you have any other||
0199|072|P|allergies. This product may contain inactive ingredients, which||
0199|073|P|can cause allergic reactions or other problems. Talk to your||
0199|074|P|pharmacist for more details.||
0199|075|P|   Before using this medication, tell your doctor or pharmacist||
0199|076|P|your medical history, especially of: heart disease, liver||
0199|077|P|disease, kidney disease, other blood/bleeding disorders (such as||
0199|078|P|hemophilia).||
0199|079|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0199|080|P|can make you more dizzy. Do not drive, use machinery, or do||
0199|081|P|anything that needs alertness until you can do it safely. Limit||
0199|082|P|alcoholic beverages. Talk to your doctor if you are using||
0199|083|P|marijuana (cannabis).||
0199|084|P|   Before having surgery, tell your doctor or dentist about all||
0199|085|P|the products you use (including prescription drugs,||
0199|086|P|nonprescription drugs, and herbal products).||
0199|087|P|   During pregnancy, this medication should be used only when||
0199|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
0199|089|P|   It is unknown if this drug passes into breast milk. Consult||
0199|090|P|your doctor before breastfeeding.||
0199|091|B|||
0199|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0199|093|I|medications work or increase your risk for serious side effects.||
0199|094|I|This document does not contain all possible drug interactions.||
0199|095|I|Keep a list of all the products you use (including||
0199|096|I|prescription/nonprescription drugs and herbal products) and share||
0199|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
0199|098|I|the dosage of any medicines without your doctor's approval.||
0199|099|I|   Some products that may interact with this drug include: blood||
0199|100|I|clotting factors (such as Factor IX complex, anti-inhibitor||
0199|101|I|coagulant complex), tretinoin.||
0199|102|I|   This medication may interfere with certain lab tests, possibly||
0199|103|I|causing false test results. Make sure lab personnel and all your||
0199|104|I|doctors know you use this drug.||
0199|105|B|||
0199|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0199|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0199|108|O|poison control center right away. US residents can call||
0199|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0199|110|B|||
0199|111|N|NOTES:  Do not share this medication with others.||
0199|112|N|   Lab and/or medical tests (such as platelet counts, blood||
0199|113|N|clotting tests, CPK levels) should be done while you are taking||
0199|114|N|this medication. Consult your doctor for more details.||
0199|115|B|||
0199|116|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
0199|117|D|right away for a new dosing schedule. Do not double the dose to||
0199|118|D|catch up.||
0199|119|B|||
0199|120|R|STORAGE:  Store at room temperature away from light and moisture.||
0199|121|R|Do not freeze. Do not store in the bathroom. Keep all medications||
0199|122|R|away from children and pets.||
0199|123|R|   Do not flush medications down the toilet or pour them into a||
0199|124|R|drain unless instructed to do so. Properly discard this product||
0199|125|R|when it is expired or no longer needed. Consult your pharmacist||
0199|126|R|or local waste disposal company.||
0199|127|B|||
0199|128|M|MEDICAL ALERT:  Your condition can cause complications in a||
0199|129|M|medical emergency. For information about enrolling in MedicAlert,||
0199|130|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0199|131|B|||
0199|132|A|Information last revised September 2024.||
0199|133|A|Copyright(c) 2025 First Databank, Inc.||
0199|134|B|||
0202|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0202|002|Z|does NOT have all possible information about this product. This||
0202|003|Z|information does not assure that this product is safe, effective,||
0202|004|Z|or appropriate for you. This information is not individual||
0202|005|Z|medical advice and does not substitute for the advice of your||
0202|006|Z|health care professional. Always ask your health care||
0202|007|Z|professional for complete information about this product and your||
0202|008|Z|specific health needs.||
0202|009|B|||
0202|010|T|POLYCARBOPHIL - ORAL||
0202|011|F|(POL-ee-KAR-boe-fil)||
0202|012|B|||
0202|013|C|COMMON BRAND NAME(S): Equalactin, Konsyl Fiber||
0202|014|B|||
0202|015|U|USES:  Polycarbophil is used to treat constipation. It is known||
0202|016|U|as a bulk-forming laxative. It increases the bulk in your stool,||
0202|017|U|an effect that helps to cause movement of the intestines. It also||
0202|018|U|works by increasing the amount of water in the stool, making the||
0202|019|U|stool softer and easier to pass.||
0202|020|B|||
0202|021|V|OTHER USES:  This section contains uses of this drug that are not||
0202|022|V|listed in the approved professional labeling for the drug but||
0202|023|V|that may be prescribed by your health care professional. Use this||
0202|024|V|drug for a condition that is listed in this section only if it||
0202|025|V|has been so prescribed by your health care professional.||
0202|026|V|   This drug may also be used to help relieve the symptoms of||
0202|027|V|irritable bowel syndrome or diarrhea.||
0202|028|B|||
0202|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
0202|030|H|doctor. If you are self-treating, follow all directions on the||
0202|031|H|product package. If you have any questions, ask your doctor or||
0202|032|H|pharmacist. To prevent choking from this medication, take it with||
0202|033|H|a full glass of water or other liquid (8 ounces/240 milliliters).||
0202|034|H|If you are taking the chewable tablets, chew the tablet||
0202|035|H|thoroughly before swallowing.||
0202|036|H|   Dosage is based on your age, medical condition, and response||
0202|037|H|to treatment. Do not increase your dose or take this drug more||
0202|038|H|often than directed.||
0202|039|H|   This product may decrease the absorption of other medications||
0202|040|H|you may be taking. Ask your doctor or pharmacist how long to wait||
0202|041|H|between doses and when you should take your medications.||
0202|042|H|   It may take 1 to 3 days before this medication starts working.||
0202|043|H|Use this medication regularly to get the most benefit from it. To||
0202|044|H|help you remember, take it at the same time(s) each day. Do not||
0202|045|H|take this medication for more than 7 days unless directed by your||
0202|046|H|doctor.||
0202|047|H|   Tell your doctor if your condition lasts or gets worse, or if||
0202|048|H|bleeding from the rectum occurs. If you think you may have a||
0202|049|H|serious medical problem, get medical help right away.||
0202|050|B|||
0202|051|S|SIDE EFFECTS:  Gas or stomach cramping may occur. If any of these||
0202|052|S|effects last or get worse, tell your doctor or pharmacist||
0202|053|S|promptly.||
0202|054|S|   If your doctor has directed you to use this product, remember||
0202|055|S|that your doctor has judged that the benefit to you is greater||
0202|056|S|than the risk of side effects. Many people using this medication||
0202|057|S|do not have serious side effects.||
0202|058|S|   This product must be taken with at least a full glass of water||
0202|059|S|or other liquid (8 ounces/240 milliliters) so that it will not||
0202|060|S|swell in the throat, causing choking. Get medical help right away||
0202|061|S|if after taking this product you have symptoms of choking such||
0202|062|S|as: chest pain, vomiting, difficulty swallowing/breathing.||
0202|063|S|   A very serious allergic reaction to this drug is rare.||
0202|064|S|However, get medical help right away if you notice any symptoms||
0202|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0202|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0202|067|S|breathing.||
0202|068|S|   This is not a complete list of possible side effects. If you||
0202|069|S|notice other effects not listed above, contact your doctor or||
0202|070|S|pharmacist.||
0202|071|S|   In the US -||
0202|072|S|   Call your doctor for medical advice about side effects. You||
0202|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0202|074|S|www.fda.gov/medwatch.||
0202|075|S|   In Canada - Call your doctor for medical advice about side||
0202|076|S|effects. You may report side effects to Health Canada at||
0202|077|S|1-866-234-2345.||
0202|078|B|||
0202|079|P|PRECAUTIONS:  Before taking polycarbophil, tell your doctor or||
0202|080|P|pharmacist if you are allergic to it; or if you have any other||
0202|081|P|allergies. This product may contain inactive ingredients, which||
0202|082|P|can cause allergic reactions or other problems. Talk to your||
0202|083|P|pharmacist for more details.||
0202|084|P|   Before using this medication, tell your doctor or pharmacist||
0202|085|P|your medical history, especially of: stomach/intestinal blockage,||
0202|086|P|difficulty swallowing, appendicitis or symptoms of appendicitis||
0202|087|P|(such as nausea/vomiting, sudden or unexplained stomach/abdominal||
0202|088|P|pain), a sudden change in bowel habits that lasts for longer than||
0202|089|P|2 weeks, bleeding from the rectum, high calcium levels||
0202|090|P|(hypercalcemia), kidney disease.||
0202|091|P|   Before having surgery, tell your doctor or dentist about all||
0202|092|P|the products you use (including prescription drugs,||
0202|093|P|nonprescription drugs, and herbal products).||
0202|094|P|   Tell your doctor if you are pregnant before using this||
0202|095|P|medication.||
0202|096|P|   It is unknown if this medication passes into breast milk.||
0202|097|P|Consult your doctor before breastfeeding.||
0202|098|B|||
0202|099|I|DRUG INTERACTIONS:  See also How To Use section.||
0202|100|I|   Drug interactions may change how your medications work or||
0202|101|I|increase your risk for serious side effects. This document does||
0202|102|I|not contain all possible drug interactions. Keep a list of all||
0202|103|I|the products you use (including prescription/nonprescription||
0202|104|I|drugs and herbal products) and share it with your doctor and||
0202|105|I|pharmacist. Do not start, stop, or change the dosage of any||
0202|106|I|medicines without your doctor's approval.||
0202|107|B|||
0202|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0202|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0202|110|O|poison control center right away. US residents can call||
0202|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0202|112|B|||
0202|113|N|NOTES:  Keep all medical and lab appointments.||
0202|114|N|   Lifestyle changes that may prevent or relieve constipation||
0202|115|N|include exercising, drinking enough water, and eating a proper||
0202|116|N|diet with fiber-rich foods such as bran, fresh fruits/vegetables.||
0202|117|N|Talk to your doctor or pharmacist about lifestyle changes that||
0202|118|N|might benefit you.||
0202|119|B|||
0202|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0202|121|D|remember. If it is near the time of the next dose, skip the||
0202|122|D|missed dose. Take your next dose at the regular time. Do not||
0202|123|D|double the dose to catch up.||
0202|124|B|||
0202|125|R|STORAGE:  Store at room temperature away from light and moisture.||
0202|126|R|Do not store in the bathroom. Keep all medications away from||
0202|127|R|children and pets.||
0202|128|R|   Do not flush medications down the toilet or pour them into a||
0202|129|R|drain unless instructed to do so. Properly discard this product||
0202|130|R|when it is expired or no longer needed. Consult your pharmacist||
0202|131|R|or local waste disposal company.||
0202|132|B|||
0202|133|A|Information last revised May 2024.||
0202|134|A|Copyright(c) 2025 First Databank, Inc.||
0202|135|B|||
0203|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0203|002|Z|does NOT have all possible information about this product. This||
0203|003|Z|information does not assure that this product is safe, effective,||
0203|004|Z|or appropriate for you. This information is not individual||
0203|005|Z|medical advice and does not substitute for the advice of your||
0203|006|Z|health care professional. Always ask your health care||
0203|007|Z|professional for complete information about this product and your||
0203|008|Z|specific health needs.||
0203|009|B|||
0203|010|T|ORPHENADRINE - INJECTION||
0203|011|F|(or-FEN-a-dreen)||
0203|012|B|||
0203|013|C|COMMON BRAND NAME(S): Norflex||
0203|014|B|||
0203|015|U|USES:  Orphenadrine is used to treat muscle spasms/pain. It is||
0203|016|U|usually used along with rest, physical therapy, and other||
0203|017|U|treatment.||
0203|018|B|||
0203|019|H|HOW TO USE:  This medication is given by injection into a vein or||
0203|020|H|muscle by a health care professional. It is given as directed by||
0203|021|H|your doctor, usually twice a day (every 12 hours). If this||
0203|022|H|medication is injected into a vein, it should be given over 5||
0203|023|H|minutes while you are lying down. Continue to lie down for 5 to||
0203|024|H|10 minutes after the injection to reduce dizziness and||
0203|025|H|lightheadedness.||
0203|026|H|   To continue to control your symptoms, your doctor may switch||
0203|027|H|you to a form of orphenadrine that is taken by mouth.||
0203|028|H|   Tell your doctor if your condition does not get better or if||
0203|029|H|it gets worse.||
0203|030|B|||
0203|031|S|SIDE EFFECTS:  Dry mouth, dizziness, drowsiness, lightheadedness,||
0203|032|S|blurred vision, nausea, vomiting, and constipation may occur. If||
0203|033|S|any of these effects last or get worse, tell your doctor or||
0203|034|S|pharmacist promptly.||
0203|035|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0203|036|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0203|037|S|substitute.||
0203|038|S|   Remember that this medication has been prescribed because your||
0203|039|S|doctor has judged that the benefit to you is greater than the||
0203|040|S|risk of side effects. Many people using this medication do not||
0203|041|S|have serious side effects.||
0203|042|S|   Tell your doctor right away if you have any serious side||
0203|043|S|effects, including: mental/mood changes (such as confusion,||
0203|044|S|anxiety, hallucinations), shaking (tremor), fast/pounding||
0203|045|S|heartbeat, fainting, difficulty urinating, eye pain.||
0203|046|S|   A very serious allergic reaction to this drug is rare.||
0203|047|S|However, get medical help right away if you notice any symptoms||
0203|048|S|of a serious allergic reaction, including: rash, itching/swelling||
0203|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0203|050|S|breathing.||
0203|051|S|   This is not a complete list of possible side effects. If you||
0203|052|S|notice other effects not listed above, contact your doctor or||
0203|053|S|pharmacist.||
0203|054|S|   In the US -||
0203|055|S|   Call your doctor for medical advice about side effects. You||
0203|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0203|057|S|www.fda.gov/medwatch.||
0203|058|S|   In Canada - Call your doctor for medical advice about side||
0203|059|S|effects. You may report side effects to Health Canada at||
0203|060|S|1-866-234-2345.||
0203|061|B|||
0203|062|P|PRECAUTIONS:  Before using orphenadrine, tell your doctor or||
0203|063|P|pharmacist if you are allergic to it; or if you have any other||
0203|064|P|allergies. This product may contain inactive ingredients (such as||
0203|065|P|sulfites), which can cause allergic reactions or other problems.||
0203|066|P|Talk to your pharmacist for more details.||
0203|067|P|   Before using this medication, tell your doctor or pharmacist||
0203|068|P|your medical history, especially of: high pressure in the eye||
0203|069|P|(glaucoma), stomach/intestinal/esophagus problems (such as||
0203|070|P|ulcers, blockage), difficulty urinating (such as due to enlarged||
0203|071|P|prostate), a certain type of muscle/nerve disease (myasthenia||
0203|072|P|gravis), heart problems (such as fast/irregular heartbeat, heart||
0203|073|P|failure).||
0203|074|P|   This drug may make you dizzy or drowsy or blur your vision.||
0203|075|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0203|076|P|drowsy. Do not drive, use machinery, or do anything that needs||
0203|077|P|alertness or clear vision until you can do it safely. Limit||
0203|078|P|alcoholic beverages. Talk to your doctor if you are using||
0203|079|P|marijuana (cannabis).||
0203|080|P|   Before having surgery, tell your doctor or dentist about all||
0203|081|P|the products you use (including prescription drugs,||
0203|082|P|nonprescription drugs, and herbal products).||
0203|083|P|   Older adults may be more sensitive to the side effects of this||
0203|084|P|drug, especially confusion, drowsiness, constipation, or trouble||
0203|085|P|urinating. Confusion and drowsiness can increase the risk of||
0203|086|P|falling.||
0203|087|P|   During pregnancy, this medication should be used only when||
0203|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
0203|089|P|   It is unknown if this drug passes into breast milk. Consult||
0203|090|P|your doctor before breastfeeding.||
0203|091|B|||
0203|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0203|093|I|medications work or increase your risk for serious side effects.||
0203|094|I|This document does not contain all possible drug interactions.||
0203|095|I|Keep a list of all the products you use (including||
0203|096|I|prescription/nonprescription drugs and herbal products) and share||
0203|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
0203|098|I|the dosage of any medicines without your doctor's approval.||
0203|099|I|   Tell your doctor or pharmacist if you are taking other||
0203|100|I|products that cause drowsiness such as opioid pain or cough||
0203|101|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0203|102|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0203|103|I|lorazepam, zolpidem), other muscle relaxants (such as||
0203|104|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0203|105|I|cetirizine, diphenhydramine).||
0203|106|I|   Check the labels on all your medicines (such as allergy or||
0203|107|I|cough-and-cold products) because they may contain ingredients||
0203|108|I|that cause drowsiness. Ask your pharmacist about using those||
0203|109|I|products safely.||
0203|110|B|||
0203|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0203|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0203|113|O|poison control center right away. US residents can call||
0203|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0203|115|O|Symptoms of overdose may include: unusual excitement,||
0203|116|O|fast/irregular heartbeat, seizures.||
0203|117|B|||
0203|118|N|NOTES:  If you are using this medication for a long time, lab||
0203|119|N|and/or medical tests may be done while you are using this||
0203|120|N|medication. Keep all medical and lab appointments. Consult your||
0203|121|N|doctor for more details.||
0203|122|B|||
0203|123|D|MISSED DOSE:  Not applicable.||
0203|124|B|||
0203|125|R|STORAGE:  Not applicable. This medication is given in a hospital||
0203|126|R|or clinic and will not be stored at home.||
0203|127|B|||
0203|128|A|Information last revised October 2024.||
0203|129|A|Copyright(c) 2025 First Databank, Inc.||
0203|130|B|||
0204|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0204|002|Z|does NOT have all possible information about this product. This||
0204|003|Z|information does not assure that this product is safe, effective,||
0204|004|Z|or appropriate for you. This information is not individual||
0204|005|Z|medical advice and does not substitute for the advice of your||
0204|006|Z|health care professional. Always ask your health care||
0204|007|Z|professional for complete information about this product and your||
0204|008|Z|specific health needs.||
0204|009|B|||
0204|010|T|LORATADINE - ORAL||
0204|011|F|(lor-AT-a-deen)||
0204|012|B|||
0204|013|C|COMMON BRAND NAME(S): Claritin||
0204|014|B|||
0204|015|U|USES:  This medication is an antihistamine that treats symptoms||
0204|016|U|such as itching, runny nose, watery eyes, and sneezing from "hay||
0204|017|U|fever" and other allergies. It is also used to relieve itching||
0204|018|U|from hives.||
0204|019|U|   Loratadine does not prevent hives or prevent/treat a serious||
0204|020|U|allergic reaction (anaphylaxis). If your doctor has prescribed||
0204|021|U|epinephrine to treat allergic reactions, always carry your||
0204|022|U|epinephrine injector with you. Do not use loratadine in place of||
0204|023|U|your epinephrine.||
0204|024|U|   If you are self-treating with this medication, it is important||
0204|025|U|to read the manufacturer's package instructions carefully so you||
0204|026|U|know when to consult your doctor or pharmacist. (See also||
0204|027|U|Precautions section.)||
0204|028|U|   If you are using the tablets or capsules, do not use in||
0204|029|U|children younger than 6 years unless directed by the doctor. If||
0204|030|U|you are using the liquid or chewable tablets, do not use in||
0204|031|U|children younger than 2 years unless directed by the doctor.||
0204|032|B|||
0204|033|H|HOW TO USE:  If you are using the over-the-counter product to||
0204|034|H|self-treat, read all the directions on the product package before||
0204|035|H|taking this medication. If your doctor has prescribed this||
0204|036|H|medication, follow your doctor's directions and the instructions||
0204|037|H|on your prescription label. If you have any questions, consult||
0204|038|H|your doctor or pharmacist.||
0204|039|H|   Take this medication by mouth with or without food, usually||
0204|040|H|once a day or as directed by your doctor or the product package.||
0204|041|H|If you are using the chewable tablets, chew each tablet well and||
0204|042|H|swallow.||
0204|043|H|   If you are using the liquid form of this medication, carefully||
0204|044|H|measure the dose using a special measuring device/spoon. Do not||
0204|045|H|use a household spoon because you may not get the correct dose.||
0204|046|H|   The dosage is based on your age, condition, and response to||
0204|047|H|treatment. Do not increase your dose or take this drug more often||
0204|048|H|than directed. Do not take more of this medication than||
0204|049|H|recommended for your age.||
0204|050|H|   Tell your doctor if your allergy symptoms do not get better||
0204|051|H|after 3 days of treatment or if your hives last more than 6||
0204|052|H|weeks. Get medical help right away if your condition gets worse||
0204|053|H|or you think you have a serious medical problem (such as a very||
0204|054|H|serious allergic reaction/anaphylaxis).||
0204|055|B|||
0204|056|S|SIDE EFFECTS:  This drug usually has no side effects. If you have||
0204|057|S|any unusual effects, contact your doctor or pharmacist promptly.||
0204|058|S|   A very serious allergic reaction to this drug is rare.||
0204|059|S|However, get medical help right away if you notice any symptoms||
0204|060|S|of a serious allergic reaction, including: rash, itching/swelling||
0204|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0204|062|S|breathing.||
0204|063|S|   This is not a complete list of possible side effects. If you||
0204|064|S|notice other effects not listed above, contact your doctor or||
0204|065|S|pharmacist.||
0204|066|S|   In the US -||
0204|067|S|   Call your doctor for medical advice about side effects. You||
0204|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0204|069|S|www.fda.gov/medwatch.||
0204|070|S|   In Canada - Call your doctor for medical advice about side||
0204|071|S|effects. You may report side effects to Health Canada at||
0204|072|S|1-866-234-2345.||
0204|073|B|||
0204|074|P|PRECAUTIONS:  Before taking loratadine, tell your doctor or||
0204|075|P|pharmacist if you are allergic to it; or to desloratadine; or if||
0204|076|P|you have any other allergies. This product may contain inactive||
0204|077|P|ingredients, which can cause allergic reactions or other||
0204|078|P|problems. Talk to your pharmacist for more details.||
0204|079|P|   Before using this medication, tell your doctor or pharmacist||
0204|080|P|your medical history. Do not self-treat with this medication||
0204|081|P|without consulting your doctor first if you have certain medical||
0204|082|P|conditions such as: kidney disease, liver disease.||
0204|083|P|   Loratadine does not usually cause drowsiness when used at||
0204|084|P|recommended doses. However, do not drive, use machinery, or do||
0204|085|P|anything that needs alertness until you can do it safely.||
0204|086|P|   If you have hives and your doctor has prescribed loratadine,||
0204|087|P|or if you are considering using this drug to treat your own||
0204|088|P|hives, tell your doctor right away if you have any of these other||
0204|089|P|symptoms because they may be signs of a more serious condition:||
0204|090|P|hives that are an unusual color, hives that look bruised or||
0204|091|P|blistered, hives that do not itch.||
0204|092|P|   Liquid products or chewable tablets may contain sugar and/or||
0204|093|P|aspartame. Caution is advised if you have diabetes,||
0204|094|P|phenylketonuria (PKU), or any other condition that requires you||
0204|095|P|to limit/avoid these substances in your diet. Ask your doctor or||
0204|096|P|pharmacist about using this product safely.||
0204|097|P|   Before having surgery, tell your doctor or dentist about all||
0204|098|P|the products you use (including prescription drugs,||
0204|099|P|nonprescription drugs, and herbal products).||
0204|100|P|   Older adults may be more sensitive to the side effects of this||
0204|101|P|drug, especially drowsiness, or confusion. These side effects can||
0204|102|P|increase the risk of falling.||
0204|103|P|   During pregnancy, this medication should be used only when||
0204|104|P|clearly needed. Discuss the risks and benefits with your doctor||
0204|105|P|before taking this drug.||
0204|106|P|   This medication passes into breast milk. However, it is||
0204|107|P|unlikely to harm a nursing infant. Consult your doctor before||
0204|108|P|breastfeeding.||
0204|109|B|||
0204|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0204|111|I|medications work or increase your risk for serious side effects.||
0204|112|I|This document does not contain all possible drug interactions.||
0204|113|I|Keep a list of all the products you use (including||
0204|114|I|prescription/nonprescription drugs and herbal products) and share||
0204|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
0204|116|I|the dosage of any medicines without your doctor's approval.||
0204|117|I|   Loratadine is very similar to desloratadine. Do not use||
0204|118|I|medications containing desloratadine while using loratadine.||
0204|119|I|   This medication may interfere with certain lab tests (such as||
0204|120|I|allergy skin testing), possibly causing false test results. Make||
0204|121|I|sure lab personnel and all your doctors know you use this drug.||
0204|122|B|||
0204|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0204|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0204|125|O|poison control center right away. US residents can call||
0204|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0204|127|O|Symptoms of overdose may include: severe drowsiness.||
0204|128|B|||
0204|129|N|NOTES:  If your doctor has prescribed this medication for you, do||
0204|130|N|not share it with others.||
0204|131|B|||
0204|132|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0204|133|D|remember. If it is near the time of the next dose, skip the||
0204|134|D|missed dose. Take your next dose at the regular time. Do not||
0204|135|D|double the dose to catch up.||
0204|136|B|||
0204|137|R|STORAGE:  Different brands/strengths of this medication may have||
0204|138|R|different storage requirements. Read the package labeling or ask||
0204|139|R|your pharmacist for the storage requirements for the product you||
0204|140|R|are using. Protect from light. Do not store in the bathroom. Keep||
0204|141|R|all medications away from children and pets.||
0204|142|R|   Do not flush medications down the toilet or pour them into a||
0204|143|R|drain unless instructed to do so. Properly discard this product||
0204|144|R|when it is expired or no longer needed. Consult your pharmacist||
0204|145|R|or local waste disposal company.||
0204|146|B|||
0204|147|A|Information last revised November 2025.||
0204|148|A|Copyright(c) 2025 First Databank, Inc.||
0204|149|B|||
0208|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0208|002|Z|does NOT have all possible information about this product. This||
0208|003|Z|information does not assure that this product is safe, effective,||
0208|004|Z|or appropriate for you. This information is not individual||
0208|005|Z|medical advice and does not substitute for the advice of your||
0208|006|Z|health care professional. Always ask your health care||
0208|007|Z|professional for complete information about this product and your||
0208|008|Z|specific health needs.||
0208|009|B|||
0208|010|T|ELECTROLYTE REPLACEMENT - ORAL||
0208|011|F|(ee-LECK-troe-lyte)||
0208|012|B|||
0208|013|U|USES:  This product is used to replace fluids and minerals (such||
0208|014|U|as sodium, potassium) lost due to diarrhea and vomiting. It helps||
0208|015|U|prevent or treat the dehydration. Having the right amount of||
0208|016|U|fluids and minerals is important for the normal functioning of||
0208|017|U|the body.||
0208|018|B|||
0208|019|H|HOW TO USE:  Take this product by mouth as directed by your||
0208|020|H|doctor, or follow all directions on the product package. If you||
0208|021|H|have any questions, ask your doctor or pharmacist.||
0208|022|H|   Some brands of the liquid form should be mixed before using,||
0208|023|H|while others should not be mixed. Ask your doctor or pharmacist||
0208|024|H|if you have questions about your specific brand. If your liquid||
0208|025|H|form is a suspension, shake the bottle well before each dose.||
0208|026|H|   If you are using the powdered form, mix the contents of the||
0208|027|H|packet in water as directed on the product package. Stir until||
0208|028|H|completely dissolved.||
0208|029|H|   Do not heat this product unless the product package states||
0208|030|H|that it is okay to do so.||
0208|031|H|   Dosage is based on your medical condition and response to||
0208|032|H|treatment.||
0208|033|H|   Do not drink fruit juices or eat foods with added salt while||
0208|034|H|taking this product unless directed by your doctor.||
0208|035|H|   Tell your doctor if your condition gets worse, if it lasts for||
0208|036|H|more than 24 hours, or if you also have severe stomach/abdominal||
0208|037|H|pain, blood in the stool/vomit, a fever, or signs of dehydration||
0208|038|H|(such as dizziness, decreased urination, severe thirst, very dry||
0208|039|H|mouth, seizures). If you think you may have a serious medical||
0208|040|H|problem, get medical help right away.||
0208|041|B|||
0208|042|S|SIDE EFFECTS:  Mild nausea and vomiting may occur. These effects||
0208|043|S|can be decreased by taking this product slowly in small amounts||
0208|044|S|with a spoon. If any of these effects last or get worse, contact||
0208|045|S|your doctor or pharmacist promptly.||
0208|046|S|   If your doctor has directed you to use this medication,||
0208|047|S|remember that your doctor has judged that the benefit to you is||
0208|048|S|greater than the risk of side effects. Many people using this||
0208|049|S|medication do not have serious side effects.||
0208|050|S|   Tell your doctor right away if you have any serious side||
0208|051|S|effects, including: dizziness, unusual weakness, swelling of||
0208|052|S|ankles/feet, mental/mood changes (such as irritability,||
0208|053|S|restlessness), seizures.||
0208|054|S|   A very serious allergic reaction to this product is rare.||
0208|055|S|However, get medical help right away if you notice any symptoms||
0208|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0208|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0208|058|S|breathing.||
0208|059|S|   This is not a complete list of possible side effects. If you||
0208|060|S|notice other effects not listed above, contact your doctor or||
0208|061|S|pharmacist.||
0208|062|S|   In the US -||
0208|063|S|   Call your doctor for medical advice about side effects. You||
0208|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0208|065|S|www.fda.gov/medwatch.||
0208|066|S|   In Canada - Call your doctor for medical advice about side||
0208|067|S|effects. You may report side effects to Health Canada at||
0208|068|S|1-866-234-2345.||
0208|069|B|||
0208|070|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0208|071|P|pharmacist if you are allergic to it; or if you have any other||
0208|072|P|allergies. This product may contain inactive ingredients, which||
0208|073|P|can cause allergic reactions or other problems. Talk to your||
0208|074|P|pharmacist for more details.||
0208|075|P|   If you have any of the following health problems, consult your||
0208|076|P|doctor or pharmacist before using this product: inability to keep||
0208|077|P|fluids in the stomach (for example, due to vomiting that is||
0208|078|P|severe or doesn't stop), difficulty urinating, intestinal||
0208|079|P|blockage.||
0208|080|P|   Before having surgery, tell your doctor or dentist about all||
0208|081|P|the products you use (including prescription drugs,||
0208|082|P|nonprescription drugs, and herbal products).||
0208|083|P|   Tell your doctor if you are pregnant before using this||
0208|084|P|medication.||
0208|085|P|   It is unknown if this product passes into breast milk. Consult||
0208|086|P|your doctor before breastfeeding.||
0208|087|B|||
0208|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0208|089|I|medications work or increase your risk for serious side effects.||
0208|090|I|This document does not contain all possible drug interactions.||
0208|091|I|Keep a list of all the products you use (including||
0208|092|I|prescription/nonprescription drugs and herbal products) and share||
0208|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
0208|094|I|the dosage of any medicines without your doctor's approval.||
0208|095|I|   Some products that may interact with this drug include:||
0208|096|I|mineral supplements (such as potassium).||
0208|097|B|||
0208|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0208|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0208|100|O|poison control center right away. US residents can call||
0208|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0208|102|B|||
0208|103|N|NOTES:  Keep all medical and lab appointments.||
0208|104|N|   As your condition improves, you can start eating soft, bland||
0208|105|N|foods such as rice, bananas, toast, boiled potatoes, or other||
0208|106|N|foods recommended by your doctor.||
0208|107|B|||
0208|108|D|MISSED DOSE:  Not applicable.||
0208|109|B|||
0208|110|R|STORAGE:  Refer to storage information printed on the package. If||
0208|111|R|you have any questions about storage, ask your pharmacist. Keep||
0208|112|R|all medications away from children and pets.||
0208|113|R|   Do not flush medications down the toilet or pour them into a||
0208|114|R|drain unless instructed to do so. Properly discard this product||
0208|115|R|when it is expired or no longer needed. Consult your pharmacist||
0208|116|R|or local waste disposal company.||
0208|117|B|||
0208|118|A|Information last revised May 2024.||
0208|119|A|Copyright(c) 2025 First Databank, Inc.||
0208|120|B|||
0209|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0209|002|Z|does NOT have all possible information about this product. This||
0209|003|Z|information does not assure that this product is safe, effective,||
0209|004|Z|or appropriate for you. This information is not individual||
0209|005|Z|medical advice and does not substitute for the advice of your||
0209|006|Z|health care professional. Always ask your health care||
0209|007|Z|professional for complete information about this product and your||
0209|008|Z|specific health needs.||
0209|009|B|||
0209|010|T|ACETYLCYSTEINE - ORAL INHALATION/ORAL||
0209|011|F|(a-SEET-il-SIS-teen)||
0209|012|B|||
0209|013|C|COMMON BRAND NAME(S): Mucomyst||
0209|014|B|||
0209|015|U|USES:  When inhaled by mouth, acetylcysteine is used to help thin||
0209|016|U|and loosen mucus in the airways due to certain lung diseases||
0209|017|U|(such as emphysema, bronchitis, cystic fibrosis, pneumonia). This||
0209|018|U|effect helps you to clear the mucus from your lungs so that you||
0209|019|U|can breathe easier.||
0209|020|U|   When taken by mouth, acetylcysteine is used to prevent liver||
0209|021|U|damage from acetaminophen overdose.||
0209|022|B|||
0209|023|V|OTHER USES:  This section contains uses of this drug that are not||
0209|024|V|listed in the approved professional labeling for the drug but||
0209|025|V|that may be prescribed by your health care professional. Use this||
0209|026|V|drug for a condition that is listed in this section only if it||
0209|027|V|has been so prescribed by your health care professional.||
0209|028|V|   .This drug may also be taken by mouth to reduce the risk of||
0209|029|V|kidney damage due to dyes from certain X-ray procedures (such as||
0209|030|V|CT scan).||
0209|031|B|||
0209|032|H|HOW TO USE:  If you are using this medication to treat lung||
0209|033|H|disease, inhale this medication by mouth as directed by your||
0209|034|H|doctor. A health care professional will show you the proper way||
0209|035|H|to use this medication. Learn all preparation and usage||
0209|036|H|instructions.||
0209|037|H|   You may notice a slight odor when you first breathe in the||
0209|038|H|medication. This odor will quickly go away. If you are using a||
0209|039|H|face mask to breathe in the medication, there may be some||
0209|040|H|stickiness on your face after use. Wash your face with water to||
0209|041|H|remove the stickiness.||
0209|042|H|   Do not mix acetylcysteine with other inhaled medications||
0209|043|H|unless directed by the doctor or pharmacist.||
0209|044|H|   If you are taking this medication by mouth, take it as||
0209|045|H|directed by your doctor. The solution is usually mixed with||
0209|046|H|another liquid (such as cola) to decrease nausea and vomiting.||
0209|047|H|Drink the medication within 1 hour of mixing.||
0209|048|H|   Tell your doctor if you vomit within 1 hour after taking your||
0209|049|H|medication. You may need to take another dose.||
0209|050|H|   The dosage is based on your medical condition and response to||
0209|051|H|treatment. For acetaminophen overdose, the dosage is also be||
0209|052|H|based on your weight.||
0209|053|H|   Tell your doctor if your condition does not get better or if||
0209|054|H|it gets worse.||
0209|055|B|||
0209|056|S|SIDE EFFECTS:  Nausea and vomiting may occur. Mouth sores and||
0209|057|S|runny nose may also occur if you are inhaling this medication by||
0209|058|S|mouth. If any of these effects last or get worse, tell your||
0209|059|S|doctor or pharmacist promptly.||
0209|060|S|   Remember that this medication has been prescribed because your||
0209|061|S|doctor has judged that the benefit to you is greater than the||
0209|062|S|risk of side effects. Many people using this medication do not||
0209|063|S|have serious side effects.||
0209|064|S|   If you are taking this medication by mouth, tell your doctor||
0209|065|S|right away if you have any serious side effects, including:||
0209|066|S|severe stomach/abdominal pain, black stools, vomit that looks||
0209|067|S|like coffee grounds.||
0209|068|S|   If you are inhaling this medication by mouth, get medical help||
0209|069|S|right away if you have any very serious side effects, including:||
0209|070|S|chest pain/tightness, trouble breathing.||
0209|071|S|   A very serious allergic reaction to this drug is rare.||
0209|072|S|However, get medical help right away if you notice any symptoms||
0209|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0209|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0209|075|S|breathing.||
0209|076|S|   This is not a complete list of possible side effects. If you||
0209|077|S|notice other effects not listed above, contact your doctor or||
0209|078|S|pharmacist.||
0209|079|S|   In the US -||
0209|080|S|   Call your doctor for medical advice about side effects. You||
0209|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0209|082|S|www.fda.gov/medwatch.||
0209|083|S|   In Canada - Call your doctor for medical advice about side||
0209|084|S|effects. You may report side effects to Health Canada at||
0209|085|S|1-866-234-2345.||
0209|086|B|||
0209|087|P|PRECAUTIONS:  Before using acetylcysteine, tell your doctor or||
0209|088|P|pharmacist if you are allergic to it; or if you have any other||
0209|089|P|allergies. This product may contain inactive ingredients, which||
0209|090|P|can cause allergic reactions or other problems. Talk to your||
0209|091|P|pharmacist for more details.||
0209|092|P|   Before using this medication, tell your doctor or pharmacist||
0209|093|P|your medical history, especially of: asthma, stomach/intestinal||
0209|094|P|ulcer.||
0209|095|P|   During pregnancy, this medication should be used only when||
0209|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
0209|097|P|   It is unknown if this drug passes into breast milk. Consult||
0209|098|P|your doctor before breastfeeding.||
0209|099|B|||
0209|100|I|DRUG INTERACTIONS:  See also How to Use section.||
0209|101|I|   Drug interactions may change how your medications work or||
0209|102|I|increase your risk for serious side effects. This document does||
0209|103|I|not contain all possible drug interactions. Keep a list of all||
0209|104|I|the products you use (including prescription/nonprescription||
0209|105|I|drugs and herbal products) and share it with your doctor and||
0209|106|I|pharmacist. Do not start, stop, or change the dosage of any||
0209|107|I|medicines without your doctor's approval.||
0209|108|I|   This medication may interfere with certain lab tests (such as||
0209|109|I|urine ketone test), possibly causing false test results. Make||
0209|110|I|sure lab personnel and all your doctors know you use this drug.||
0209|111|B|||
0209|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0209|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0209|114|O|poison control center right away. US residents can call||
0209|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0209|116|B|||
0209|117|N|NOTES:  Do not share this medication with others.||
0209|118|N|   For acetaminophen overdose, lab and/or medical tests (such as||
0209|119|N|liver/kidney function, acetaminophen drug levels, blood mineral||
0209|120|N|levels) should be done while you are using this medication. Keep||
0209|121|N|all medical and lab appointments. Consult your doctor for more||
0209|122|N|details.||
0209|123|B|||
0209|124|D|MISSED DOSE:  If you are using this medication to treat lung||
0209|125|D|disease and miss a dose, use it as soon as you remember. If it is||
0209|126|D|near the time of the next dose, skip the missed dose. Use your||
0209|127|D|next dose at the regular time. Do not double the dose to catch||
0209|128|D|up.||
0209|129|D|   If you are using this medication to treat acetaminophen||
0209|130|D|overdose, it is important to take each dose as scheduled. If you||
0209|131|D|miss a dose, ask your doctor or pharmacist right away for a new||
0209|132|D|dosing schedule.||
0209|133|B|||
0209|134|R|STORAGE:  Store at room temperature away from light. Do not store||
0209|135|R|in the bathroom. After opening the vial, store this medication in||
0209|136|R|the refrigerator. Opened vials expire after 4 days. The solution||
0209|137|R|may change to a light purple color. This is normal and will not||
0209|138|R|affect how the drug works. Keep all medications away from||
0209|139|R|children and pets.||
0209|140|R|   Do not flush medications down the toilet or pour them into a||
0209|141|R|drain unless instructed to do so. Properly discard this product||
0209|142|R|when it is expired or no longer needed. Consult your pharmacist||
0209|143|R|or local waste disposal company.||
0209|144|B|||
0209|145|A|Information last revised October 2024.||
0209|146|A|Copyright(c) 2025 First Databank, Inc.||
0209|147|B|||
0211|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0211|002|Z|does NOT have all possible information about this product. This||
0211|003|Z|information does not assure that this product is safe, effective,||
0211|004|Z|or appropriate for you. This information is not individual||
0211|005|Z|medical advice and does not substitute for the advice of your||
0211|006|Z|health care professional. Always ask your health care||
0211|007|Z|professional for complete information about this product and your||
0211|008|Z|specific health needs.||
0211|009|B|||
0211|010|T|FILGRASTIM - INJECTION||
0211|011|F|(fil-GRA-stim)||
0211|012|B|||
0211|013|C|COMMON BRAND NAME(S): Granix, Neupogen, Nivestym, Nypozi,||
0211|014|C|Releuko, Zarxio||
0211|015|B|||
0211|016|U|USES:  Filgrastim is a man-made version of a certain natural||
0211|017|U|substance made by your body. It is used to help your body make||
0211|018|U|more white blood cells. White blood cells are important to help||
0211|019|U|you fight off infections. Filgrastim is given to people whose||
0211|020|U|ability to make white blood cells is reduced (for instance, due||
0211|021|U|to chemotherapy, chronic neutropenia, or exposure to large||
0211|022|U|amounts of radiation). It is also used in certain treatment||
0211|023|U|procedures (such as bone marrow/stem cell transplant).||
0211|024|U|   This monograph is about the following filgrastim products:||
0211|025|U|filgrastim, filgrastim-aafi, filgrastim-ayow, filgrastim-sndz,||
0211|026|U|filgrastim-txid, and tbo-filgrastim.||
0211|027|B|||
0211|028|H|HOW TO USE:  Read the Patient Information Leaflet and||
0211|029|H|Instructions for Use if available from your pharmacist before you||
0211|030|H|start using filgrastim and each time you get a refill. If you||
0211|031|H|have any questions, ask your doctor or pharmacist.||
0211|032|H|   Depending on your filgrastim product, this medication is||
0211|033|H|injected under the skin or into a vein. Use as directed by your||
0211|034|H|doctor, usually once a day. The dosage and length of treatment||
0211|035|H|are based on your medical condition, weight, lab tests, and||
0211|036|H|response to treatment.||
0211|037|H|   If you are using this medication at home, learn all||
0211|038|H|preparation and usage instructions from your health care||
0211|039|H|professional and the product package. Take the medication out of||
0211|040|H|the refrigerator at least 30 minutes before you inject it to||
0211|041|H|allow it to reach room temperature. Do not shake the medication.||
0211|042|H|Before using, check this product for particles or discoloration.||
0211|043|H|If either is present, do not use the liquid. If you are injecting||
0211|044|H|this drug under the skin, first clean the skin you are going to||
0211|045|H|inject into (the injection site) with rubbing alcohol. Change the||
0211|046|H|injection site each time to lessen injury under the skin. Do not||
0211|047|H|inject into skin that is bruised, tender, red, hard, or that has||
0211|048|H|scars or stretch marks. To lessen bruising, do not rub the||
0211|049|H|injection site after a shot. Learn how to store and discard||
0211|050|H|medical supplies safely.||
0211|051|H|   Use this medication regularly to get the most benefit from it.||
0211|052|H|To help you remember, use it at the same time each day.||
0211|053|H|   Do not increase your dose or use this drug more often or for||
0211|054|H|longer than prescribed. Your condition will not improve any||
0211|055|H|faster, and your risk of side effects will increase.||
0211|056|H|   If you are receiving cancer chemotherapy, you should not use||
0211|057|H|this medication within 24 hours before or 24 hours after||
0211|058|H|chemotherapy. Ask your doctor for specific directions about when||
0211|059|H|to use this medication.||
0211|060|B|||
0211|061|S|SIDE EFFECTS:  Dizziness, headache, and aching or pain in the||
0211|062|S|bones, joints, and muscles may occur. Taking a non-aspirin pain||
0211|063|S|reliever such as acetaminophen may help relieve pain. Ask your||
0211|064|S|doctor or pharmacist for more details. Redness, swelling,||
0211|065|S|itching, or bruising at the injection site may also occur. If any||
0211|066|S|of these effects last or get worse, tell your doctor or||
0211|067|S|pharmacist promptly.||
0211|068|S|   Remember that this medication has been prescribed because your||
0211|069|S|doctor has judged that the benefit to you is greater than the||
0211|070|S|risk of side effects. Many people using this medication do not||
0211|071|S|have serious side effects.||
0211|072|S|   Tell your doctor right away if you have any serious side||
0211|073|S|effects, including: easy bleeding/bruising, pink/bloody urine,||
0211|074|S|bloody vomit, coughing up blood, fast heartbeat, fever,||
0211|075|S|purple/red spots on your skin, back pain.||
0211|076|S|   Get medical help right away if you have any very serious side||
0211|077|S|effects, including: breathing problems (such as fast breathing,||
0211|078|S|shortness of breath), unusual decrease in urination, unusual||
0211|079|S|tiredness, swelling/puffiness of the body.||
0211|080|S|   Rarely, serious (possibly fatal) damage to the spleen may||
0211|081|S|occur. Get medical help right away if you develop||
0211|082|S|stomach/abdominal pain or shoulder pain.||
0211|083|S|   Rarely, this medication may increase the risk of developing a||
0211|084|S|certain bone marrow disorder (myelodysplastic syndrome-MDS) or||
0211|085|S|blood cancer (acute myeloid leukemia-AML) in people with||
0211|086|S|congenital neutropenia or in people with breast or lung cancer||
0211|087|S|who are receiving chemotherapy/radiation. Ask your doctor for||
0211|088|S|more details.||
0211|089|S|   Filgrastim can commonly cause a rash that is usually not||
0211|090|S|serious. However, you may not be able to tell it apart from a||
0211|091|S|rare rash that could be a sign of a severe reaction. Get medical||
0211|092|S|help right away if you develop any rash.||
0211|093|S|   A very serious allergic reaction to this drug is rare.||
0211|094|S|However, get medical help right away if you notice any symptoms||
0211|095|S|of a serious allergic reaction, including: rash, itching/swelling||
0211|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0211|097|S|breathing.||
0211|098|S|   This is not a complete list of possible side effects. If you||
0211|099|S|notice other effects not listed above, contact your doctor or||
0211|100|S|pharmacist.||
0211|101|S|   In the US -||
0211|102|S|   Call your doctor for medical advice about side effects. You||
0211|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0211|104|S|www.fda.gov/medwatch.||
0211|105|S|   In Canada - Call your doctor for medical advice about side||
0211|106|S|effects. You may report side effects to Health Canada at||
0211|107|S|1-866-234-2345.||
0211|108|B|||
0211|109|P|PRECAUTIONS:  Before using filgrastim, tell your doctor or||
0211|110|P|pharmacist if you are allergic to it; or to any filgrastim or||
0211|111|P|pegfilgrastim products; or to eflapegrastim; or if you have any||
0211|112|P|other allergies. This product may contain inactive ingredients||
0211|113|P|(such as dry natural rubber/latex in the needle cover on the||
0211|114|P|prefilled syringe of some brands), which can cause allergic||
0211|115|P|reactions or other problems. Talk to your pharmacist for more||
0211|116|P|details.||
0211|117|P|   Before using this medication, tell your doctor or pharmacist||
0211|118|P|your medical history, especially of: kidney disease, sickle cell||
0211|119|P|disease, spleen problems, radiation treatment.||
0211|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0211|121|P|can make you more dizzy. Do not drive, use machinery, or do||
0211|122|P|anything that needs alertness until you can do it safely. Limit||
0211|123|P|alcoholic beverages. Talk to your doctor if you are using||
0211|124|P|marijuana (cannabis).||
0211|125|P|   Before having surgery, tell your doctor or dentist about all||
0211|126|P|the products you use (including prescription drugs,||
0211|127|P|nonprescription drugs, and herbal products).||
0211|128|P|   During pregnancy, this medication should be used only when||
0211|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
0211|130|P|   This medication passes into breast milk. Consult your doctor||
0211|131|P|before breastfeeding.||
0211|132|B|||
0211|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0211|134|I|medications work or increase your risk for serious side effects.||
0211|135|I|This document does not contain all possible drug interactions.||
0211|136|I|Keep a list of all the products you use (including||
0211|137|I|prescription/nonprescription drugs and herbal products) and share||
0211|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
0211|139|I|the dosage of any medicines without your doctor's approval.||
0211|140|I|   Filgrastim is very similar to pegfilgrastim. Do not use a||
0211|141|I|pegfilgrastim product while using a filgrastim product.||
0211|142|I|   This medication may interfere with certain lab tests (such as||
0211|143|I|bone imaging tests), possibly causing false test results. Make||
0211|144|I|sure lab personnel and all your doctors know you use this drug.||
0211|145|B|||
0211|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0211|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0211|148|O|poison control center right away. US residents can call||
0211|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0211|150|B|||
0211|151|N|NOTES:  Do not share this medication with others.||
0211|152|N|   Lab and/or medical tests (such as complete blood count, kidney||
0211|153|N|function) should be done while you are using this medication.||
0211|154|N|Keep all medical and lab appointments. Consult your doctor for||
0211|155|N|more details.||
0211|156|B|||
0211|157|D|MISSED DOSE:  It is important to get each dose of this medication||
0211|158|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0211|159|D|right away for a new dosing schedule. Do not double the dose to||
0211|160|D|catch up.||
0211|161|B|||
0211|162|R|STORAGE:  Store in the refrigerator. Do not freeze or shake. Keep||
0211|163|R|the medication in the original packaging to protect from light.||
0211|164|R|This medication may also be stored at room temperature if needed.||
0211|165|R|If the medication is stored at room temperature, discard it||
0211|166|R|within the time directed in your product package. Keep all||
0211|167|R|medications away from children and pets.||
0211|168|R|   Do not flush medications down the toilet or pour them into a||
0211|169|R|drain unless instructed to do so. Properly discard this product||
0211|170|R|when it is expired or no longer needed. Consult your pharmacist||
0211|171|R|or local waste disposal company.||
0211|172|B|||
0211|173|A|Information last revised November 2024.||
0211|174|A|Copyright(c) 2025 First Databank, Inc.||
0211|175|B|||
0213|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0213|002|Z|does NOT have all possible information about this product. This||
0213|003|Z|information does not assure that this product is safe, effective,||
0213|004|Z|or appropriate for you. This information is not individual||
0213|005|Z|medical advice and does not substitute for the advice of your||
0213|006|Z|health care professional. Always ask your health care||
0213|007|Z|professional for complete information about this product and your||
0213|008|Z|specific health needs.||
0213|009|B|||
0213|010|T|HYDROXYPROPYL CELLULOSE INSERT - OPHTHALMIC||
0213|011|F|(hye-DROX-ee-PROE-pil SEL-ue-lose)||
0213|012|B|||
0213|013|C|COMMON BRAND NAME(S): Lacrisert||
0213|014|B|||
0213|015|U|USES:  This medication is an insert that is placed in your eye to||
0213|016|U|treat dry eyes. It is usually used when an artificial tears||
0213|017|U|solution is not successful. This medication may also be used to||
0213|018|U|treat certain other eye disorders (keratitis, decreased corneal||
0213|019|U|sensitivity). It works by keeping the eye moist, helping to||
0213|020|U|protect the eye from injury and infection and to decrease||
0213|021|U|symptoms of dry eyes such as burning, itching, and feeling as if||
0213|022|U|something is in the eye.||
0213|023|B|||
0213|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0213|025|H|from your pharmacist before you start using this medication and||
0213|026|H|each time you get a refill. Learn all preparation and usage||
0213|027|H|instructions. If you have any questions, ask your doctor or||
0213|028|H|pharmacist.||
0213|029|H|   Use this medication in the affected eye(s) as directed by your||
0213|030|H|doctor, usually 1 to 2 times daily.||
0213|031|H|   If you wear contact lenses, remove them before using this||
0213|032|H|medication. Ask your doctor when you may replace your contact||
0213|033|H|lenses.||
0213|034|H|   To apply this medication, wash your hands first. To avoid||
0213|035|H|contamination, do not touch the insert or let it touch any other||
0213|036|H|surface besides the applicator. Use the supplied applicator to||
0213|037|H|place 1 insert into the eye.||
0213|038|H|   Rinse the applicator with hot running water after use. Shake||
0213|039|H|off any visible water droplets, and then replace the applicator||
0213|040|H|in the storage container.||
0213|041|H|   Avoid rubbing your eyes when using this medication. If the||
0213|042|H|insert comes out, you may replace it with another one. Your||
0213|043|H|doctor may direct you to also use an artificial tears solution or||
0213|044|H|saline drops with this medication. Use those medications exactly||
0213|045|H|as prescribed.||
0213|046|H|   Wait several minutes for your vision to clear before driving||
0213|047|H|or operating machinery.||
0213|048|H|   Use this medication regularly in order to get the most benefit||
0213|049|H|from it. To help you remember, use it at the same time(s) each||
0213|050|H|day.||
0213|051|H|   It may take several weeks to see the full benefit of this||
0213|052|H|medication. Tell your doctor if your condition does not get||
0213|053|H|better or if it gets worse.||
0213|054|B|||
0213|055|S|SIDE EFFECTS:  Eye discomfort/irritation/redness, tearing, eye||
0213|056|S|sensitivity to light, sticky eyelashes, or temporary blurred||
0213|057|S|vision may occur. If any of these effects last or get worse, tell||
0213|058|S|your doctor or pharmacist promptly.||
0213|059|S|   Remember that this medication has been prescribed because your||
0213|060|S|doctor has judged that the benefit to you is greater than the||
0213|061|S|risk of side effects. Many people using this medication do not||
0213|062|S|have serious side effects.||
0213|063|S|   Remove the insert and tell your doctor right away if you have||
0213|064|S|any serious side effects, including: eye redness/irritation that||
0213|065|S|doesn't go away, eye pain, swelling in or around the eyes, vision||
0213|066|S|changes.||
0213|067|S|   A very serious allergic reaction to this drug is rare.||
0213|068|S|However, get medical help right away if you notice any symptoms||
0213|069|S|of a serious allergic reaction, including: rash, itching/swelling||
0213|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0213|071|S|breathing.||
0213|072|S|   This is not a complete list of possible side effects. If you||
0213|073|S|notice other effects not listed above, contact your doctor or||
0213|074|S|pharmacist.||
0213|075|S|   In the US -||
0213|076|S|   Call your doctor for medical advice about side effects. You||
0213|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0213|078|S|www.fda.gov/medwatch.||
0213|079|S|   In Canada - Call your doctor for medical advice about side||
0213|080|S|effects. You may report side effects to Health Canada at||
0213|081|S|1-866-234-2345.||
0213|082|B|||
0213|083|P|PRECAUTIONS:  Before using hydroxypropyl cellulose, tell your||
0213|084|P|doctor or pharmacist if you are allergic to it; or if you have||
0213|085|P|any other allergies. This product may contain inactive||
0213|086|P|ingredients, which can cause allergic reactions or other||
0213|087|P|problems. Talk to your pharmacist for more details.||
0213|088|P|   Before using this medication, tell your doctor or pharmacist||
0213|089|P|your medical history, especially of: eye||
0213|090|P|surgery/injury/infection/disease.||
0213|091|P|   After you apply this drug, your vision may become temporarily||
0213|092|P|blurred. Do not drive, use machinery, or do anything that needs||
0213|093|P|clear vision until you can do it safely.||
0213|094|P|   During pregnancy, this medication should be used only when||
0213|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
0213|096|P|   It is unknown if this drug passes into breast milk. Consult||
0213|097|P|your doctor before breastfeeding.||
0213|098|B|||
0213|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0213|100|I|medications work or increase your risk for serious side effects.||
0213|101|I|This document does not contain all possible drug interactions.||
0213|102|I|Keep a list of all the products you use (including||
0213|103|I|prescription/nonprescription drugs and herbal products) and share||
0213|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
0213|105|I|the dosage of any medicines without your doctor's approval.||
0213|106|B|||
0213|107|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0213|108|O|has overdosed and has serious symptoms such as passing out or||
0213|109|O|trouble breathing, call 911. Otherwise, call a poison control||
0213|110|O|center right away. US residents can call 1-800-222-1222. Canada||
0213|111|O|residents can call 1-844-764-7669.||
0213|112|B|||
0213|113|N|NOTES:  Do not share this medication with others.||
0213|114|B|||
0213|115|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0213|116|D|If it is near the time of the next dose, skip the missed dose.||
0213|117|D|Use your next dose at the regular time. Do not double the dose to||
0213|118|D|catch up.||
0213|119|B|||
0213|120|R|STORAGE:  Store at room temperature away from heat. Keep all||
0213|121|R|medications away from children and pets.||
0213|122|R|   Do not flush medications down the toilet or pour them into a||
0213|123|R|drain unless instructed to do so. Properly discard this product||
0213|124|R|when it is expired or no longer needed. Consult your pharmacist||
0213|125|R|or local waste disposal company.||
0213|126|B|||
0213|127|A|Information last revised October 2024.||
0213|128|A|Copyright(c) 2025 First Databank, Inc.||
0213|129|B|||
0214|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0214|002|Z|does NOT have all possible information about this product. This||
0214|003|Z|information does not assure that this product is safe, effective,||
0214|004|Z|or appropriate for you. This information is not individual||
0214|005|Z|medical advice and does not substitute for the advice of your||
0214|006|Z|health care professional. Always ask your health care||
0214|007|Z|professional for complete information about this product and your||
0214|008|Z|specific health needs.||
0214|009|B|||
0214|010|T|DECONGESTANT DROPS - NASAL||
0214|011|B|||
0214|012|U|USES:  This medication is used for temporary relief of congestion||
0214|013|U|in the nose caused by various conditions including the common||
0214|014|U|cold, sinusitis, hay fever, and allergies. It works by narrowing||
0214|015|U|the blood vessels in the nose area, reducing swelling and||
0214|016|U|congestion.||
0214|017|B|||
0214|018|V|OTHER USES:  This section contains uses of this drug that are not||
0214|019|V|listed in the approved professional labeling for the drug but||
0214|020|V|that may be prescribed by your health care professional. Use this||
0214|021|V|drug for a condition that is listed in this section only if it||
0214|022|V|has been so prescribed by your health care professional.||
0214|023|V|   This drug may also be used to relieve "plugged ears" and to||
0214|024|V|reduce swelling in the nose before certain surgeries or||
0214|025|V|procedures.||
0214|026|B|||
0214|027|H|HOW TO USE:  Use this medication in the nose as directed. Follow||
0214|028|H|all directions on the product package, or use as directed by your||
0214|029|H|doctor. If you have any questions, ask your doctor or pharmacist.||
0214|030|H|   To apply nasal drops, wash your hands first. To avoid||
0214|031|H|contamination, do not touch the dropper tip or let it touch your||
0214|032|H|nose or any other surface. If needed, have another person place||
0214|033|H|the drops in your nose.||
0214|034|H|   Gently blow your nose before using this drug. Tilt your head||
0214|035|H|back while sitting on a chair or lying down. Hold the dropper||
0214|036|H|over the affected nostril and apply the directed number of drops.||
0214|037|H|Keep your head tilted for a few minutes. Repeat these steps with||
0214|038|H|the other nostril if needed. Do not swallow the medication if it||
0214|039|H|drips into the throat.||
0214|040|H|   This medication provides only temporary relief. Do not use||
0214|041|H|more medication or use it more often or for longer than directed||
0214|042|H|because doing so may increase the risk of side effects. Also, do||
0214|043|H|not use this medication for more than 3 days because doing so may||
0214|044|H|cause a condition called rebound congestion. Symptoms of rebound||
0214|045|H|congestion include long-term redness and swelling inside the nose||
0214|046|H|and increased runny nose. If this occurs, stop using this||
0214|047|H|medication and consult your doctor or pharmacist.||
0214|048|H|   Tell your doctor if your condition gets worse or lasts after 3||
0214|049|H|days.||
0214|050|B|||
0214|051|S|SIDE EFFECTS:  Temporary burning, stinging, dryness in the nose,||
0214|052|S|runny nose, and sneezing may occur. If any of these effects last||
0214|053|S|or get worse, tell your doctor or pharmacist promptly.||
0214|054|S|   If your doctor has directed you to use this medication,||
0214|055|S|remember that your doctor has judged that the benefit to you is||
0214|056|S|greater than the risk of side effects. Many people using this||
0214|057|S|medication do not have serious side effects.||
0214|058|S|   This medication may raise your blood pressure. Check your||
0214|059|S|blood pressure regularly and tell your doctor if the results are||
0214|060|S|high.||
0214|061|S|   Tell your doctor right away if you have any serious side||
0214|062|S|effects, including: slow/fast/pounding heartbeat, dizziness,||
0214|063|S|nausea, headache, mental/mood changes, trouble sleeping, shaking||
0214|064|S|(tremors), unusual sweating, unusual weakness.||
0214|065|S|   A very serious allergic reaction to this drug is rare.||
0214|066|S|However, get medical help right away if you notice any symptoms||
0214|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0214|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0214|069|S|breathing.||
0214|070|S|   This is not a complete list of possible side effects. If you||
0214|071|S|notice other effects not listed above, contact your doctor or||
0214|072|S|pharmacist.||
0214|073|S|   In the US -||
0214|074|S|   Call your doctor for medical advice about side effects. You||
0214|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0214|076|S|www.fda.gov/medwatch.||
0214|077|S|   In Canada - Call your doctor for medical advice about side||
0214|078|S|effects. You may report side effects to Health Canada at||
0214|079|S|1-866-234-2345.||
0214|080|B|||
0214|081|P|PRECAUTIONS:  Before using this nasal decongestant, tell your||
0214|082|P|doctor or pharmacist if you are allergic to it; or to other||
0214|083|P|sympathomimetics (such as pseudoephedrine); or if you have any||
0214|084|P|other allergies. This product may contain inactive ingredients,||
0214|085|P|which can cause allergic reactions or other problems. Talk to||
0214|086|P|your pharmacist for more details.||
0214|087|P|   If you have any of the following health problems, consult your||
0214|088|P|doctor or pharmacist before using this product: heart/blood||
0214|089|P|vessel disease (such as coronary artery disease), overactive||
0214|090|P|thyroid (hyperthyroidism), diabetes, high blood pressure,||
0214|091|P|difficulty urinating (due to enlarged prostate).||
0214|092|P|   Before having surgery, tell your doctor or dentist about all||
0214|093|P|the products you use (including prescription drugs,||
0214|094|P|nonprescription drugs, and herbal products).||
0214|095|P|   Children may be more sensitive to the side effects of this||
0214|096|P|drug. Check the product package or consult with your doctor or||
0214|097|P|pharmacist about whether these nasal drops can be used by||
0214|098|P|children.||
0214|099|P|   During pregnancy, this medication should be used only when||
0214|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0214|101|P|   It is unknown if this drug passes into breast milk. Consult||
0214|102|P|your doctor before breastfeeding.||
0214|103|B|||
0214|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0214|105|I|medications work or increase your risk for serious side effects.||
0214|106|I|This document does not contain all possible drug interactions.||
0214|107|I|Keep a list of all the products you use (including||
0214|108|I|prescription/nonprescription drugs and herbal products) and share||
0214|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
0214|110|I|the dosage of any medicines without your doctor's approval.||
0214|111|I|   Taking MAO inhibitors with this medication may cause a serious||
0214|112|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0214|113|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0214|114|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0214|115|I|selegiline, tranylcypromine) during treatment with this||
0214|116|I|medication. Most MAO inhibitors should also not be taken for two||
0214|117|I|weeks before treatment with this medication. Ask your doctor when||
0214|118|I|to start or stop taking this medication.||
0214|119|B|||
0214|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0214|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0214|122|O|poison control center right away. US residents can call||
0214|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0214|124|O|Symptoms of overdose may include: drowsiness, slow heartbeat,||
0214|125|O|dizziness, fainting.||
0214|126|B|||
0214|127|N|NOTES:  Do not share this medication with others. Use of this||
0214|128|N|container by more than one person may spread infection.||
0214|129|N|   There are many nasal decongestants available, many without a||
0214|130|N|prescription. Talk with your doctor or pharmacist about which||
0214|131|N|product is best for you.||
0214|132|B|||
0214|133|D|MISSED DOSE:  Not applicable.||
0214|134|B|||
0214|135|R|STORAGE:  Refer to storage information printed on the package.||
0214|136|R|Protect from heat and light. Keep all medications away from||
0214|137|R|children and pets.||
0214|138|R|   Do not flush medications down the toilet or pour them into a||
0214|139|R|drain unless instructed to do so. Properly discard this product||
0214|140|R|when it is expired or no longer needed. Consult your pharmacist||
0214|141|R|or local waste disposal company.||
0214|142|B|||
0214|143|A|Information last revised July 2025.||
0214|144|A|Copyright(c) 2025 First Databank, Inc.||
0214|145|B|||
0215|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0215|002|Z|does NOT have all possible information about this product. This||
0215|003|Z|information does not assure that this product is safe, effective,||
0215|004|Z|or appropriate for you. This information is not individual||
0215|005|Z|medical advice and does not substitute for the advice of your||
0215|006|Z|health care professional. Always ask your health care||
0215|007|Z|professional for complete information about this product and your||
0215|008|Z|specific health needs.||
0215|009|B|||
0215|010|T|SODIUM CHLORIDE SOLUTION - OPHTHALMIC||
0215|011|F|(SOE-dee-um KLOR-ide)||
0215|012|B|||
0215|013|C|COMMON BRAND NAME(S): Muro-128||
0215|014|B|||
0215|015|U|USES:  This product is used to reduce swelling of the surface of||
0215|016|U|the eye (cornea) in certain eye conditions. Decreasing swelling||
0215|017|U|of the cornea may lessen eye discomfort or irritation caused by||
0215|018|U|the swelling. This product works by drawing fluid out of the||
0215|019|U|cornea to reduce swelling.||
0215|020|B|||
0215|021|H|HOW TO USE:  Follow all directions on the product package. If||
0215|022|H|your doctor has prescribed this medication, use this medication||
0215|023|H|in the affected eye(s) as directed by your doctor. If you have||
0215|024|H|any questions, ask your doctor or pharmacist.||
0215|025|H|   If you are wearing contact lenses, remove them before using||
0215|026|H|eye drops. Wait at least 15 minutes before replacing your contact||
0215|027|H|lenses.||
0215|028|H|   To apply eye drops, wash your hands first. To avoid||
0215|029|H|contamination, do not touch the dropper tip or let it touch your||
0215|030|H|eye or any other surface.||
0215|031|H|   Tilt your head back, look up, and pull down the lower eyelid||
0215|032|H|to make a pouch. Hold the dropper directly over your eye and||
0215|033|H|place 1 drop into the pouch. Release the eyelid and gently close||
0215|034|H|your eyes. Place one finger at the corner of your eye (near the||
0215|035|H|nose) and apply gentle pressure for 1 to 2 minutes. This will||
0215|036|H|prevent the medication from draining out. Try not to blink and do||
0215|037|H|not rub your eye. Repeat these steps if your dose is for more||
0215|038|H|than 1 drop and for your other eye if so directed. Do not rinse||
0215|039|H|the dropper. Replace the dropper cap after each use.||
0215|040|H|   Remove extra solution around the eye with a tissue, and wash||
0215|041|H|your hands to remove any medicine that may be on them.||
0215|042|H|   If you are using another kind of eye medication (such as drops||
0215|043|H|or ointments), wait at least 5 minutes before using the other||
0215|044|H|medication. Use eye drops before ointments to allow the eye drops||
0215|045|H|to enter the eye.||
0215|046|H|   Wait several minutes for your vision to clear before driving||
0215|047|H|or operating machinery.||
0215|048|H|   This product is recommended for use under a doctor's||
0215|049|H|direction. If your condition gets worse, if it lasts for more||
0215|050|H|than 3 days, or if you think you may have a serious medical||
0215|051|H|problem, get medical help right away.||
0215|052|B|||
0215|053|S|SIDE EFFECTS:  Eye discomfort, burning, redness, or temporary||
0215|054|S|blurred vision may occur. If any of these effects last or get||
0215|055|S|worse, tell your doctor or pharmacist promptly.||
0215|056|S|   If your doctor has directed you to use this medication,||
0215|057|S|remember that your doctor has judged that the benefit to you is||
0215|058|S|greater than the risk of side effects. Many people using this||
0215|059|S|medication do not have serious side effects.||
0215|060|S|   Tell your doctor right away if you have any serious side||
0215|061|S|effects, including: eye pain, vision changes.||
0215|062|S|   A very serious allergic reaction to this drug is rare.||
0215|063|S|However, get medical help right away if you notice any symptoms||
0215|064|S|of a serious allergic reaction, including: rash, itching/swelling||
0215|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0215|066|S|breathing.||
0215|067|S|   This is not a complete list of possible side effects. If you||
0215|068|S|notice other effects not listed above, contact your doctor or||
0215|069|S|pharmacist.||
0215|070|S|   In the US -||
0215|071|S|   Call your doctor for medical advice about side effects. You||
0215|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0215|073|S|www.fda.gov/medwatch.||
0215|074|S|   In Canada - Call your doctor for medical advice about side||
0215|075|S|effects. You may report side effects to Health Canada at||
0215|076|S|1-866-234-2345.||
0215|077|B|||
0215|078|P|PRECAUTIONS:  Before using sodium chloride eye solution, tell||
0215|079|P|your doctor or pharmacist if you are allergic to it; or if you||
0215|080|P|have any other allergies. This product may contain inactive||
0215|081|P|ingredients, which can cause allergic reactions or other||
0215|082|P|problems. Talk to your pharmacist for more details.||
0215|083|P|   Before using this product, tell your doctor or pharmacist your||
0215|084|P|medical history, especially of: other eye problems.||
0215|085|P|   Before having surgery, tell your doctor or dentist about all||
0215|086|P|the products you use (including prescription drugs,||
0215|087|P|nonprescription drugs, and herbal products).||
0215|088|P|   This product is safe to use during pregnancy.||
0215|089|P|   It is unknown if this drug passes into breast milk. Consult||
0215|090|P|your doctor before breastfeeding.||
0215|091|B|||
0215|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0215|093|I|medications work or increase your risk for serious side effects.||
0215|094|I|This document does not contain all possible drug interactions.||
0215|095|I|Keep a list of all the products you use (including||
0215|096|I|prescription/nonprescription drugs and herbal products) and share||
0215|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
0215|098|I|the dosage of any medicines without your doctor's approval.||
0215|099|B|||
0215|100|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0215|101|O|has overdosed and has serious symptoms such as passing out or||
0215|102|O|trouble breathing, call 911. Otherwise, call a poison control||
0215|103|O|center right away. US residents can call 1-800-222-1222. Canada||
0215|104|O|residents can call 1-844-764-7669.||
0215|105|B|||
0215|106|N|NOTES:  Keep all medical and lab appointments.||
0215|107|B|||
0215|108|D|MISSED DOSE:  If you are using this product on a regular schedule||
0215|109|D|and miss a dose, use it as soon as you remember. If it is near||
0215|110|D|the time of the next dose, skip the missed dose. Use your next||
0215|111|D|dose at the regular time. Do not double the dose to catch up.||
0215|112|B|||
0215|113|R|STORAGE:  Refer to storage information printed on the package. Do||
0215|114|R|not freeze. If you have any questions about storage, ask your||
0215|115|R|pharmacist. Keep all medications away from children and pets.||
0215|116|R|   Do not flush medications down the toilet or pour them into a||
0215|117|R|drain unless instructed to do so. Properly discard this product||
0215|118|R|when it is expired or no longer needed. Consult your pharmacist||
0215|119|R|or local waste disposal company.||
0215|120|B|||
0215|121|A|Information last revised May 2024.||
0215|122|A|Copyright(c) 2025 First Databank, Inc.||
0215|123|B|||
0216|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0216|002|Z|does NOT have all possible information about this product. This||
0216|003|Z|information does not assure that this product is safe, effective,||
0216|004|Z|or appropriate for you. This information is not individual||
0216|005|Z|medical advice and does not substitute for the advice of your||
0216|006|Z|health care professional. Always ask your health care||
0216|007|Z|professional for complete information about this product and your||
0216|008|Z|specific health needs.||
0216|009|B|||
0216|010|T|INTERFERON BETA-1B - INJECTION||
0216|011|F|(IN-ter-FEER-on BAY-ta-wun-bee)||
0216|012|B|||
0216|013|C|COMMON BRAND NAME(S): Betaseron, Extavia||
0216|014|B|||
0216|015|U|USES:  This medication is used to treat multiple sclerosis (MS).||
0216|016|U|Interferon is not a cure for MS, but it may help to slow disease||
0216|017|U|worsening and decrease flare-ups of symptoms (such as balance||
0216|018|U|problems, numbness, or weakness).||
0216|019|B|||
0216|020|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
0216|021|H|provided by your pharmacist before you start using this||
0216|022|H|medication and each time you get a refill. Ask your health care||
0216|023|H|professional how to prepare and use this medication. If you have||
0216|024|H|any questions, ask your doctor or pharmacist.||
0216|025|H|   Inject this medication under the skin as directed by your||
0216|026|H|doctor, usually every other day. The injection is given in the||
0216|027|H|thigh, abdomen, buttock, or the back of the upper arm. It is best||
0216|028|H|to use this medication near bedtime to reduce side effects. The||
0216|029|H|dosage is based on your medical condition and response to||
0216|030|H|treatment. To reduce your risk of side effects, your doctor may||
0216|031|H|direct you to start this medication at a low dose and gradually||
0216|032|H|increase your dose. Follow your doctor's instructions carefully.||
0216|033|H|   Before using, check this product for particles or||
0216|034|H|discoloration. If either is present, do not use the liquid.||
0216|035|H|Before injecting each dose, clean the skin you are going to||
0216|036|H|inject into (the injection site) with rubbing alcohol. Change the||
0216|037|H|injection site each time to lessen injury under the skin. Do not||
0216|038|H|inject into skin that is red, sore, scarred, or infected. Tell||
0216|039|H|your doctor of any skin reactions that do not go away after a few||
0216|040|H|days. To lessen bruising, do not rub the injection site after a||
0216|041|H|shot. Learn how to store and discard medical supplies safely.||
0216|042|H|   Use this medication regularly to get the most benefit from it.||
0216|043|H|To help you remember, use it at the same time for each scheduled||
0216|044|H|dose.||
0216|045|H|   Tell your doctor if your condition gets worse.||
0216|046|B|||
0216|047|S|SIDE EFFECTS:  Injection site reactions (such as||
0216|048|S|pain/swelling/redness), abdominal pain, constipation, diarrhea,||
0216|049|S|upset stomach, and nausea may occur. If any of these effects last||
0216|050|S|or get worse, tell your doctor or pharmacist promptly.||
0216|051|S|   Most people have flu-like symptoms such as headache,||
0216|052|S|tiredness, fever, chills, and muscle aches when they first start||
0216|053|S|this medication. These symptoms usually last about 1 day after||
0216|054|S|the injection and improve or go away after a few months of||
0216|055|S|continued use. You can lessen these side effects by injecting||
0216|056|S|this medicine at bedtime and by using fever reducers/pain||
0216|057|S|relievers such as acetaminophen or ibuprofen before each dose.||
0216|058|S|Ask your doctor or pharmacist for more information.||
0216|059|S|   Remember that this medication has been prescribed because your||
0216|060|S|doctor has judged that the benefit to you is greater than the||
0216|061|S|risk of side effects. Many people using this medication do not||
0216|062|S|have serious side effects.||
0216|063|S|   Tell your doctor right away if you have any serious side||
0216|064|S|effects, including: mental/mood changes (such as new or worsening||
0216|065|S|depression, thoughts of suicide, psychosis), feeling too hot or||
0216|066|S|cold (more than others around you), blue fingers/toes, easy||
0216|067|S|bleeding/bruising, pus or change in skin color at the injection||
0216|068|S|site, joint pain/swelling, signs of kidney problems (such as a||
0216|069|S|change in the amount of urine), signs of liver problems (such as||
0216|070|S|nausea/vomiting that doesn't stop, loss of appetite,||
0216|071|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
0216|072|S|butterfly-shaped rash on the nose and cheeks, new or worsening||
0216|073|S|symptoms of heart failure (such as shortness of breath, swelling||
0216|074|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
0216|075|S|   Get medical help right away if you have any very serious side||
0216|076|S|effects, including: seizures.||
0216|077|S|   This medication may lower your ability to fight infections.||
0216|078|S|This may make you more likely to get a serious (rarely fatal)||
0216|079|S|infection or make any infection you have worse. Tell your doctor||
0216|080|S|right away if you have any signs of infections (such as sore||
0216|081|S|throat that doesn't go away, fever, chills).||
0216|082|S|   A very serious allergic reaction to this drug is rare.||
0216|083|S|However, get medical help right away if you notice any symptoms||
0216|084|S|of a serious allergic reaction, including: rash, itching/swelling||
0216|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0216|086|S|breathing.||
0216|087|S|   This is not a complete list of possible side effects. If you||
0216|088|S|notice other effects not listed above, contact your doctor or||
0216|089|S|pharmacist.||
0216|090|S|   In the US -||
0216|091|S|   Call your doctor for medical advice about side effects. You||
0216|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0216|093|S|www.fda.gov/medwatch.||
0216|094|S|   In Canada - Call your doctor for medical advice about side||
0216|095|S|effects. You may report side effects to Health Canada at||
0216|096|S|1-866-234-2345.||
0216|097|B|||
0216|098|P|PRECAUTIONS:  Before using interferon, tell your doctor or||
0216|099|P|pharmacist if you are allergic to it; or to products containing||
0216|100|P|human albumin; or if you have any other allergies. This product||
0216|101|P|may contain inactive ingredients (such as latex found in some||
0216|102|P|brands), which can cause allergic reactions or other problems.||
0216|103|P|Talk to your pharmacist for more details.||
0216|104|P|   Before using this medication, tell your doctor or pharmacist||
0216|105|P|your medical history, especially of: bleeding/blood problems,||
0216|106|P|heart problems (such as heart failure, angina, fast/irregular||
0216|107|P|heartbeat), liver disease, mental/mood disorders (such as||
0216|108|P|depression, psychosis, suicidal thoughts), seizure disorder,||
0216|109|P|thyroid disease.||
0216|110|P|   Interferon can make you more likely to get infections or may||
0216|111|P|make current infections worse. Stay away from anyone who has an||
0216|112|P|infection that may easily spread (such as chickenpox, COVID-19,||
0216|113|P|measles, flu). Talk to your doctor if you have been exposed to an||
0216|114|P|infection or for more details.||
0216|115|P|   Tell your health care professional that you are using||
0216|116|P|interferon before having any immunizations/vaccinations. Avoid||
0216|117|P|contact with people who have recently received live vaccines||
0216|118|P|(such as flu vaccine inhaled through the nose).||
0216|119|P|   Before having surgery, tell your doctor or dentist about all||
0216|120|P|the products you use (including prescription drugs,||
0216|121|P|nonprescription drugs, and herbal products).||
0216|122|P|   During pregnancy, this medication should be used only when||
0216|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
0216|124|P|   It is unknown if this drug passes into breast milk. Consult||
0216|125|P|your doctor before breastfeeding.||
0216|126|B|||
0216|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0216|128|I|medications work or increase your risk for serious side effects.||
0216|129|I|This document does not contain all possible drug interactions.||
0216|130|I|Keep a list of all the products you use (including||
0216|131|I|prescription/nonprescription drugs and herbal products) and share||
0216|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
0216|133|I|the dosage of any medicines without your doctor's approval.||
0216|134|B|||
0216|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0216|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0216|137|O|poison control center right away. US residents can call||
0216|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0216|139|B|||
0216|140|N|NOTES:  Do not share this medication with others.||
0216|141|N|   Lab and/or medical tests (such as complete blood count,||
0216|142|N|liver/thyroid function) should be done while you are using this||
0216|143|N|medication. Keep all medical and lab appointments.||
0216|144|B|||
0216|145|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember,||
0216|146|D|and ask your doctor or pharmacist right away for a new dosing||
0216|147|D|schedule. Your next injection should be used about 48 hours (2||
0216|148|D|days) after you actually receive the missed dose. Do not use this||
0216|149|D|medication 2 days in a row. Do not double the dose to catch up.||
0216|150|B|||
0216|151|R|STORAGE:  Store the unmixed medication at room temperature. Store||
0216|152|R|the mixed medication in the refrigerator. Do not freeze. Discard||
0216|153|R|any unused portion after 3 hours. Keep all medications away from||
0216|154|R|children and pets.||
0216|155|R|   Do not flush medications down the toilet or pour them into a||
0216|156|R|drain unless instructed to do so. Properly discard this product||
0216|157|R|when it is expired or no longer needed. Consult your pharmacist||
0216|158|R|or local waste disposal company.||
0216|159|B|||
0216|160|A|Information last revised April 2025.||
0216|161|A|Copyright(c) 2025 First Databank, Inc.||
0216|162|B|||
0217|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0217|002|Z|does NOT have all possible information about this product. This||
0217|003|Z|information does not assure that this product is safe, effective,||
0217|004|Z|or appropriate for you. This information is not individual||
0217|005|Z|medical advice and does not substitute for the advice of your||
0217|006|Z|health care professional. Always ask your health care||
0217|007|Z|professional for complete information about this product and your||
0217|008|Z|specific health needs.||
0217|009|B|||
0217|010|T|FELBAMATE - ORAL||
0217|011|F|(fel-BAM-ate)||
0217|012|B|||
0217|013|C|COMMON BRAND NAME(S): Felbatol||
0217|014|B|||
0217|015|W|WARNING:  Severe (sometimes fatal) blood/bone marrow problems||
0217|016|W|(such as low red/white blood cells and platelets) and liver||
0217|017|W|problems have occurred with felbamate. Felbamate should be used||
0217|018|W|only by people with severe seizures (epilepsy) that cannot be||
0217|019|W|controlled with other medications. Do not use this drug if you||
0217|020|W|have liver problems. Discuss the risks and benefits with your||
0217|021|W|doctor before starting felbamate.||
0217|022|W|   Tell your doctor right away if you have signs of infection||
0217|023|W|(such as sore throat that doesn't go away, fever, chills), signs||
0217|024|W|of anemia (such as unusual tiredness), easy bruising/bleeding, or||
0217|025|W|signs of liver problems (such as nausea/vomiting that doesn't||
0217|026|W|stop, stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0217|027|W|Usually, people who have liver problems while taking this drug||
0217|028|W|should not start taking it again.||
0217|029|W|   Your doctor will check certain blood tests (liver function,||
0217|030|W|complete blood count) and may have you see a doctor who treats||
0217|031|W|blood/bone marrow problems before you start felbamate and while||
0217|032|W|you use this drug. Blood/bone marrow problems may also occur||
0217|033|W|after you stop taking the drug. Blood tests may be needed for||
0217|034|W|some time after you stop taking felbamate. Keep all medical and||
0217|035|W|lab appointments.||
0217|036|B|||
0217|037|U|USES:  Felbamate is used to treat severe seizures. This||
0217|038|U|medication should be used only when you cannot take other||
0217|039|U|medications or when other medications have not been able to||
0217|040|U|control your seizures. Felbamate is known as an anticonvulsant or||
0217|041|U|anti-epileptic drug.||
0217|042|B|||
0217|043|H|HOW TO USE:  Read and sign the Informed Consent form provided by||
0217|044|H|your doctor. Read the Medication Guide provided by your||
0217|045|H|pharmacist before you start taking felbamate and each time you||
0217|046|H|get a refill. If you have any questions, ask your doctor or||
0217|047|H|pharmacist before starting felbamate.||
0217|048|H|   Take this medication by mouth with or without food as directed||
0217|049|H|by your doctor, usually 3 to 4 times a day. Take with food or||
0217|050|H|milk if stomach upset occurs.||
0217|051|H|   If you are using the liquid form of this medication, shake the||
0217|052|H|bottle well before each dose. Carefully measure the dose using a||
0217|053|H|special measuring device/spoon. Do not use a household spoon||
0217|054|H|because you may not get the correct dose.||
0217|055|H|   The dosage is based on your medical condition and response to||
0217|056|H|treatment. Children's dosage is also based on weight. To reduce||
0217|057|H|your risk of side effects, your doctor may direct you to start||
0217|058|H|this medication at a low dose and gradually increase your dose.||
0217|059|H|   Take this medication regularly to get the most benefit from||
0217|060|H|it. To help you remember, take it at the same times each day.||
0217|061|H|   Do not stop taking this medication without consulting your||
0217|062|H|doctor. Seizures may become worse when this drug is suddenly||
0217|063|H|stopped. Your dose may need to be gradually decreased.||
0217|064|H|   If you are already taking other anti-seizure medications,||
0217|065|H|carefully follow your doctor's directions for adjusting the dose||
0217|066|H|of these other medications when you start taking felbamate.||
0217|067|H|   Tell your doctor if your seizures get worse.||
0217|068|B|||
0217|069|S|SIDE EFFECTS:  See also Warning section.||
0217|070|S|   Drowsiness, dizziness, nausea, vomiting, diarrhea,||
0217|071|S|constipation, trouble sleeping, loss of coordination, headache,||
0217|072|S|blurred/double vision, hiccups, or loss of appetite may occur. If||
0217|073|S|any of these effects last or get worse, tell your doctor or||
0217|074|S|pharmacist promptly.||
0217|075|S|   Remember that this medication has been prescribed because your||
0217|076|S|doctor has judged that the benefit to you is greater than the||
0217|077|S|risk of side effects. Many people using this medication do not||
0217|078|S|have serious side effects.||
0217|079|S|   Tell your doctor right away if you have any serious side||
0217|080|S|effects, including: fainting.||
0217|081|S|   A small number of people who take anticonvulsants for any||
0217|082|S|condition (such as seizure, bipolar disorder, pain) may||
0217|083|S|experience depression, suicidal thoughts/attempts, or other||
0217|084|S|mental/mood problems. Tell your doctor right away if you or your||
0217|085|S|family/caregiver notice any unusual/sudden changes in your mood,||
0217|086|S|thoughts, or behavior such as signs of depression, suicidal||
0217|087|S|thoughts/attempts, thoughts about harming yourself.||
0217|088|S|   A very serious allergic reaction to this drug is rare.||
0217|089|S|However, get medical help right away if you notice any symptoms||
0217|090|S|of a serious allergic reaction, including: rash, itching/swelling||
0217|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0217|092|S|breathing.||
0217|093|S|   This is not a complete list of possible side effects. If you||
0217|094|S|notice other effects not listed above, contact your doctor or||
0217|095|S|pharmacist.||
0217|096|S|   In the US -||
0217|097|S|   Call your doctor for medical advice about side effects. You||
0217|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0217|099|S|www.fda.gov/medwatch.||
0217|100|S|   In Canada - Call your doctor for medical advice about side||
0217|101|S|effects. You may report side effects to Health Canada at||
0217|102|S|1-866-234-2345.||
0217|103|B|||
0217|104|P|PRECAUTIONS:  Before taking felbamate, tell your doctor or||
0217|105|P|pharmacist if you are allergic to it; or to meprobamate; or if||
0217|106|P|you have any other allergies. This product may contain inactive||
0217|107|P|ingredients, which can cause allergic reactions or other||
0217|108|P|problems. Talk to your pharmacist for more details.||
0217|109|P|   Before using this medication, tell your doctor or pharmacist||
0217|110|P|your medical history, especially of: blood/bone marrow disorders||
0217|111|P|(such as anemia, bleeding problems, low white blood cell count),||
0217|112|P|liver disease, kidney disease, mental/mood disorders (such as||
0217|113|P|depression, suicidal thoughts).||
0217|114|P|   This drug may make you dizzy or drowsy or blur your vision. It||
0217|115|P|may also cause double vision. Alcohol or marijuana (cannabis) can||
0217|116|P|make you more dizzy or drowsy. Do not drive, use machinery, or do||
0217|117|P|anything that needs alertness or clear vision until you can do it||
0217|118|P|safely. Limit alcoholic beverages. Talk to your doctor if you are||
0217|119|P|using marijuana (cannabis).||
0217|120|P|   Before having surgery, tell your doctor or dentist about all||
0217|121|P|the products you use (including prescription drugs,||
0217|122|P|nonprescription drugs, and herbal products).||
0217|123|P|   Older adults may be more sensitive to the side effects of this||
0217|124|P|drug, especially dizziness, loss of coordination, or fainting.||
0217|125|P|These side effects can increase the risk of falling.||
0217|126|P|   During pregnancy, this medication should be used only when||
0217|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
0217|128|P|   This medication passes into breast milk. Because of the||
0217|129|P|possible risk to the infant, breastfeeding is not recommended||
0217|130|P|while using this medication. Consult your doctor before||
0217|131|P|breastfeeding.||
0217|132|B|||
0217|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0217|134|I|medications work or increase your risk for serious side effects.||
0217|135|I|This document does not contain all possible drug interactions.||
0217|136|I|Keep a list of all the products you use (including||
0217|137|I|prescription/nonprescription drugs and herbal products) and share||
0217|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
0217|139|I|the dosage of any medicines without your doctor's approval.||
0217|140|I|   Some products that may interact with this drug include:||
0217|141|I|clopidogrel, orlistat.||
0217|142|I|   This medication may decrease the effectiveness of hormonal||
0217|143|I|birth control such as pills, patch, or ring. This could cause||
0217|144|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0217|145|I|use reliable backup birth control methods while using this||
0217|146|I|medication. Also tell your doctor if you have any new spotting or||
0217|147|I|breakthrough bleeding, because these may be signs that your birth||
0217|148|I|control is not working well.||
0217|149|I|   Tell your doctor or pharmacist if you are taking other||
0217|150|I|products that cause drowsiness including alcohol, marijuana||
0217|151|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0217|152|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0217|153|I|zolpidem), muscle relaxants (such as carisoprodol,||
0217|154|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
0217|155|I|hydrocodone).||
0217|156|I|   Check the labels on all your medicines (such as allergy or||
0217|157|I|cough-and-cold products) because they may contain ingredients||
0217|158|I|that cause drowsiness. Ask your pharmacist about using those||
0217|159|I|products safely.||
0217|160|B|||
0217|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0217|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0217|163|O|poison control center right away. US residents can call||
0217|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0217|165|B|||
0217|166|N|NOTES:  Do not share this medication with others.||
0217|167|N|   Lab and/or medical tests (such as complete blood count,||
0217|168|N|kidney/liver tests) should be done before, during, and after||
0217|169|N|treatment with this medication. See also Warning section.||
0217|170|B|||
0217|171|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0217|172|D|remember. If it is near the time of the next dose, skip the||
0217|173|D|missed dose. Take your next dose at the regular time. Do not||
0217|174|D|double the dose to catch up.||
0217|175|B|||
0217|176|R|STORAGE:  Store at room temperature away from light and moisture.||
0217|177|R|Do not store in the bathroom. Keep all medications away from||
0217|178|R|children and pets.||
0217|179|R|   Do not flush medications down the toilet or pour them into a||
0217|180|R|drain unless instructed to do so. Properly discard this product||
0217|181|R|when it is expired or no longer needed. Consult your pharmacist||
0217|182|R|or local waste disposal company.||
0217|183|B|||
0217|184|M|MEDICAL ALERT:  Your condition can cause complications in a||
0217|185|M|medical emergency. For information about enrolling in MedicAlert,||
0217|186|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0217|187|B|||
0217|188|A|Information last revised August 2024.||
0217|189|A|Copyright(c) 2025 First Databank, Inc.||
0217|190|B|||
0225|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0225|002|Z|does NOT have all possible information about this product. This||
0225|003|Z|information does not assure that this product is safe, effective,||
0225|004|Z|or appropriate for you. This information is not individual||
0225|005|Z|medical advice and does not substitute for the advice of your||
0225|006|Z|health care professional. Always ask your health care||
0225|007|Z|professional for complete information about this product and your||
0225|008|Z|specific health needs.||
0225|009|B|||
0225|010|T|VERAPAMIL EXTENDED-RELEASE CAPSULE - ORAL||
0225|011|F|(ver-AP-a-mil)||
0225|012|B|||
0225|013|C|COMMON BRAND NAME(S): Verelan||
0225|014|B|||
0225|015|U|USES:  Verapamil is used to treat high blood pressure. Lowering||
0225|016|U|high blood pressure helps prevent strokes, heart attacks, and||
0225|017|U|kidney problems. Verapamil belongs to a class of drugs known as||
0225|018|U|calcium channel blockers. It works by relaxing blood vessels so||
0225|019|U|blood can flow more easily. Verapamil may also lower your heart||
0225|020|U|rate.||
0225|021|B|||
0225|022|V|OTHER USES:  This section contains uses of this drug that are not||
0225|023|V|listed in the approved professional labeling for the drug but||
0225|024|V|that may be prescribed by your health care professional. Use this||
0225|025|V|drug for a condition that is listed in this section only if it||
0225|026|V|has been so prescribed by your health care professional.||
0225|027|V|   This drug may also be used for other heart diseases (such as||
0225|028|V|hypertrophic cardiomyopathy, fast/irregular heartbeats). It may||
0225|029|V|also be used to reduce the risk of chest pain (angina).||
0225|030|B|||
0225|031|H|HOW TO USE:  Take this medication by mouth with or without food||
0225|032|H|as directed by your doctor, usually once daily. Depending on your||
0225|033|H|specific brand, take this medication either in the morning or at||
0225|034|H|bedtime as directed. Consult your pharmacist if you have any||
0225|035|H|questions about when to take the medication.||
0225|036|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
0225|037|H|Doing so can release all of the drug at once and may increase||
0225|038|H|your risk of side effects.||
0225|039|H|   If you have trouble swallowing the capsule, you may open the||
0225|040|H|capsule and carefully sprinkle its contents on a spoonful of||
0225|041|H|soft, cool applesauce just before you take it. Swallow all of the||
0225|042|H|drug/food mixture right away without chewing. Then rinse your||
0225|043|H|mouth and swallow the rinse liquid to make sure that you have||
0225|044|H|swallowed all of the medicine. Do not chew the mixture or prepare||
0225|045|H|a supply in advance.||
0225|046|H|   The dosage is based on your medical condition and response to||
0225|047|H|treatment.||
0225|048|H|   Use this medication regularly to get the most benefit from it.||
0225|049|H|To help you remember, take it at the same time each day.||
0225|050|H|   For the treatment of high blood pressure, it may take a week||
0225|051|H|before you get the full benefit of this drug. Keep taking this||
0225|052|H|medication even if you feel well. Most people with high blood||
0225|053|H|pressure do not feel sick.||
0225|054|H|   Do not stop taking this medication without consulting your||
0225|055|H|doctor. Some conditions may become worse when this drug is||
0225|056|H|suddenly stopped. Your dose may need to be gradually decreased.||
0225|057|H|   Tell your doctor if your condition does not get better or if||
0225|058|H|it gets worse (your blood pressure readings remain high or||
0225|059|H|increase).||
0225|060|B|||
0225|061|S|SIDE EFFECTS:  Dizziness, slow heartbeat, constipation, stomach||
0225|062|S|upset, nausea, headache, or tiredness may occur. If any of these||
0225|063|S|effects last or get worse, tell your doctor or pharmacist||
0225|064|S|promptly.||
0225|065|S|   To reduce the risk of dizziness and lightheadedness, get up||
0225|066|S|slowly when rising from a sitting or lying position.||
0225|067|S|   Remember that this medication has been prescribed because your||
0225|068|S|doctor has judged that the benefit to you is greater than the||
0225|069|S|risk of side effects. Many people using this medication do not||
0225|070|S|have serious side effects.||
0225|071|S|   Tell your doctor right away if you have any serious side||
0225|072|S|effects, including: severe dizziness, fainting, new or worsening||
0225|073|S|symptoms of heart failure (such as shortness of breath, swelling||
0225|074|S|ankles/feet, unusual tiredness, unusual/sudden weight gain), very||
0225|075|S|slow heartbeat.||
0225|076|S|   This drug may rarely cause serious (possibly fatal) liver||
0225|077|S|disease. Get medical help right away if you have any symptoms of||
0225|078|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
0225|079|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0225|080|S|urine.||
0225|081|S|   A very serious allergic reaction to this drug is rare.||
0225|082|S|However, get medical help right away if you notice any symptoms||
0225|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0225|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0225|085|S|breathing.||
0225|086|S|   This is not a complete list of possible side effects. If you||
0225|087|S|notice other effects not listed above, contact your doctor or||
0225|088|S|pharmacist.||
0225|089|S|   In the US -||
0225|090|S|   Call your doctor for medical advice about side effects. You||
0225|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0225|092|S|www.fda.gov/medwatch.||
0225|093|S|   In Canada - Call your doctor for medical advice about side||
0225|094|S|effects. You may report side effects to Health Canada at||
0225|095|S|1-866-234-2345.||
0225|096|B|||
0225|097|P|PRECAUTIONS:  Before taking verapamil, tell your doctor or||
0225|098|P|pharmacist if you are allergic to it; or if you have any other||
0225|099|P|allergies. This product may contain inactive ingredients, which||
0225|100|P|can cause allergic reactions or other problems. Talk to your||
0225|101|P|pharmacist for more details.||
0225|102|P|   Before using this medication, tell your doctor or pharmacist||
0225|103|P|your medical history, especially of: certain types of heart||
0225|104|P|rhythm problems (such as second- or third-degree atrioventricular||
0225|105|P|block, sick sinus syndrome unless you have a pacemaker,||
0225|106|P|Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome),||
0225|107|P|heart failure, certain muscle/nerve disorders (muscular||
0225|108|P|dystrophy, myasthenia gravis), liver disease, kidney disease.||
0225|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0225|110|P|can make you more dizzy. Do not drive, use machinery, or do||
0225|111|P|anything that needs alertness until you can do it safely. Limit||
0225|112|P|alcoholic beverages. Talk to your doctor if you are using||
0225|113|P|marijuana (cannabis).||
0225|114|P|   Before having surgery, tell your doctor or dentist about all||
0225|115|P|the products you use (including prescription drugs,||
0225|116|P|nonprescription drugs, and herbal products).||
0225|117|P|   Older adults may be more sensitive to the side effects of this||
0225|118|P|drug, especially constipation, or swelling ankles/feet.||
0225|119|P|   During pregnancy, this medication should be used only when||
0225|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
0225|121|P|   This medication passes into breast milk, but is unlikely to||
0225|122|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0225|123|B|||
0225|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0225|125|I|medications work or increase your risk for serious side effects.||
0225|126|I|This document does not contain all possible drug interactions.||
0225|127|I|Keep a list of all the products you use (including||
0225|128|I|prescription/nonprescription drugs and herbal products) and share||
0225|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
0225|130|I|the dosage of any medicines without your doctor's approval.||
0225|131|I|   Some products that may interact with this drug include:||
0225|132|I|aliskiren, clonidine, disopyramide, dofetilide, fingolimod,||
0225|133|I|labetalol, lithium.||
0225|134|I|   Other medications can affect the removal of verapamil from||
0225|135|I|your body, which may affect how verapamil works. Examples include||
0225|136|I|erythromycin, rifamycins (such as rifampin), ritonavir, St.||
0225|137|I|John's wort, among others.||
0225|138|I|   Verapamil can slow down the removal of other medications from||
0225|139|I|your body, which may affect how they work. Examples of affected||
0225|140|I|drugs include colchicine, elacestrant, fezolinetant, flibanserin,||
0225|141|I|ivabradine, lomitapide, midazolam, rilzabrutinib, taletrectinib,||
0225|142|I|triazolam, among others.||
0225|143|I|   Some products have ingredients that could raise your heart||
0225|144|I|rate or blood pressure. Tell your pharmacist what products you||
0225|145|I|are using, and ask how to use them safely (especially||
0225|146|I|cough-and-cold products, diet aids, or NSAIDs such as||
0225|147|I|ibuprofen/naproxen).||
0225|148|B|||
0225|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0225|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0225|151|O|poison control center right away. US residents can call||
0225|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0225|153|O|Symptoms of overdose may include: very slow heartbeat, severe||
0225|154|O|dizziness, fainting.||
0225|155|B|||
0225|156|N|NOTES:  Do not share this medication with others.||
0225|157|N|   Lifestyle changes that may help this medication work better||
0225|158|N|include exercising, stopping smoking, and eating a||
0225|159|N|low-cholesterol/low-fat diet. Consult your doctor for more||
0225|160|N|details.||
0225|161|N|   Lab and/or medical tests (such as liver function) should be||
0225|162|N|done while you are taking this medication. Keep all medical and||
0225|163|N|lab appointments. Consult your doctor for more details.||
0225|164|N|   Check your blood pressure and pulse (heart rate) regularly||
0225|165|N|while taking this medication. Learn how to check your own blood||
0225|166|N|pressure and pulse at home, and share the results with your||
0225|167|N|doctor.||
0225|168|N|   There are different brands and types of this medication||
0225|169|N|available. Some do not have the same effects. Do not change||
0225|170|N|brands or types without consulting your doctor or pharmacist.||
0225|171|B|||
0225|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0225|173|D|remember. If it is near the time of the next dose, skip the||
0225|174|D|missed dose. Take your next dose at the regular time. Do not||
0225|175|D|double the dose to catch up.||
0225|176|B|||
0225|177|R|STORAGE:  Store at room temperature away from light and moisture.||
0225|178|R|Do not store in the bathroom. Keep all medications away from||
0225|179|R|children and pets.||
0225|180|R|   Do not flush medications down the toilet or pour them into a||
0225|181|R|drain unless instructed to do so. Properly discard this product||
0225|182|R|when it is expired or no longer needed. Consult your pharmacist||
0225|183|R|or local waste disposal company.||
0225|184|B|||
0225|185|M|MEDICAL ALERT:  Your condition can cause complications in a||
0225|186|M|medical emergency. For information about enrolling in MedicAlert,||
0225|187|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0225|188|B|||
0225|189|A|Information last revised September 2025.||
0225|190|A|Copyright(c) 2025 First Databank, Inc.||
0225|191|B|||
0226|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0226|002|Z|does NOT have all possible information about this product. This||
0226|003|Z|information does not assure that this product is safe, effective,||
0226|004|Z|or appropriate for you. This information is not individual||
0226|005|Z|medical advice and does not substitute for the advice of your||
0226|006|Z|health care professional. Always ask your health care||
0226|007|Z|professional for complete information about this product and your||
0226|008|Z|specific health needs.||
0226|009|B|||
0226|010|T|ANTHRALIN - TOPICAL||
0226|011|F|(AN-thra-lin)||
0226|012|B|||
0226|013|C|COMMON BRAND NAME(S): Drithocreme||
0226|014|B|||
0226|015|U|USES:  This medication is used for the treatment of long-term||
0226|016|U|psoriasis. Anthralin is a man-made version of a natural substance||
0226|017|U|found in goa powder, which is from the araroba tree. It works by||
0226|018|U|slowing down the growth of skin cells. This product does not||
0226|019|U|contain a corticosteroid or coal tar. It is not meant to be used||
0226|020|U|for a severe outbreak of psoriasis. Do not use this drug if the||
0226|021|U|skin is inflamed or irritated.||
0226|022|B|||
0226|023|H|HOW TO USE:  Exactly follow all directions from your doctor and||
0226|024|H|pharmacist. Learn how to apply the medicine, how long to leave it||
0226|025|H|on the scalp or skin, and how to avoid staining.||
0226|026|H|   This medication is for use on the skin and/or scalp.||
0226|027|H|   To prevent discoloration of fingernails, apply this medication||
0226|028|H|using plastic gloves.||
0226|029|H|   Apply a thin layer to the area with psoriasis, usually once||
0226|030|H|daily. Avoid the normal skin/scalp. Rub in well. If normal skin||
0226|031|H|surrounding the treated areas becomes too irritated, you may||
0226|032|H|cover the normal skin with petroleum jelly to protect it.||
0226|033|H|   To treat the scalp, wash hair first with a shampoo to remove||
0226|034|H|loose scales. Rinse off the shampoo, then apply this medication||
0226|035|H|as directed, only on the psoriasis area.||
0226|036|H|   Follow your doctor's directions for how long to leave the drug||
0226|037|H|on the skin/scalp (usually starting at 10-30 minutes per||
0226|038|H|treatment), then remove the drug. First, rinse with||
0226|039|H|cool-to-lukewarm water (less than 80 degrees F/27 degrees C).||
0226|040|H|Then, if you are treating the scalp, shampoo the scalp, and if||
0226|041|H|you are treating the skin, wash the treated skin by taking a bath||
0226|042|H|or shower using soap and hot water.||
0226|043|H|   After using this medicine, rinse hands right away with||
0226|044|H|lukewarm water, then wash with soap and warm water.||
0226|045|H|   Do not allow the drug to come in contact with eyes, mucous||
0226|046|H|membranes (such as lips, mouth, nose), or genital area. If this||
0226|047|H|occurs, flush with plenty of cool-to-lukewarm water. If||
0226|048|H|irritation occurs, contact your doctor right away.||
0226|049|H|   Caution is advised when applying on the areas between toes and||
0226|050|H|fingers, on the face, or in skin folds. If too much irritation||
0226|051|H|occurs after using this medication, stop using this medication||
0226|052|H|and tell your doctor.||
0226|053|H|   Treatment is usually continued until the affected area is||
0226|054|H|entirely clear.||
0226|055|H|   Tell your doctor if your condition lasts or gets worse.||
0226|056|B|||
0226|057|S|SIDE EFFECTS:  Temporary redness or irritation of the treated||
0226|058|S|skin may occur. If any of these effects last or get worse, tell||
0226|059|S|your doctor or pharmacist promptly.||
0226|060|S|   Remember that this medication has been prescribed because your||
0226|061|S|doctor has judged that the benefit to you is greater than the||
0226|062|S|risk of side effects. Many people using this medication do not||
0226|063|S|have serious side effects.||
0226|064|S|   Tell your doctor right away if you have any serious side||
0226|065|S|effects, including: increased soreness of skin, spread of||
0226|066|S|psoriasis.||
0226|067|S|   This medication may temporarily discolor fingernails or||
0226|068|S|discolor gray/white hair. It will also stain skin and fabrics||
0226|069|S|(see also Precautions section).||
0226|070|S|   A very serious allergic reaction to this drug is rare.||
0226|071|S|However, get medical help right away if you notice any symptoms||
0226|072|S|of a serious allergic reaction, including: rash, itching/swelling||
0226|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0226|074|S|breathing.||
0226|075|S|   This is not a complete list of possible side effects. If you||
0226|076|S|notice other effects not listed above, contact your doctor or||
0226|077|S|pharmacist.||
0226|078|S|   In the US -||
0226|079|S|   Call your doctor for medical advice about side effects. You||
0226|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0226|081|S|www.fda.gov/medwatch.||
0226|082|S|   In Canada - Call your doctor for medical advice about side||
0226|083|S|effects. You may report side effects to Health Canada at||
0226|084|S|1-866-234-2345.||
0226|085|B|||
0226|086|P|PRECAUTIONS:  Before using anthralin, tell your doctor or||
0226|087|P|pharmacist if you are allergic to it; or if you have any other||
0226|088|P|allergies. This product may contain inactive ingredients, which||
0226|089|P|can cause allergic reactions or other problems. Talk to your||
0226|090|P|pharmacist for more details.||
0226|091|P|   Before using this medication, tell your doctor or pharmacist||
0226|092|P|your medical history, especially of: kidney disease.||
0226|093|P|   To prevent staining of clothing or bed linen, a protective||
0226|094|P|dressing may be useful. To prevent staining of the tub or shower||
0226|095|P|(after washing off the medicine), rinse tub/shower with lukewarm||
0226|096|P|water. Then use a cleanser to remove any deposits left on the||
0226|097|P|surface.||
0226|098|P|   During pregnancy, this medication should be used only when||
0226|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
0226|100|P|   It is unknown if this drug passes into breast milk. Consult||
0226|101|P|your doctor before breastfeeding.||
0226|102|B|||
0226|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0226|104|I|medications work or increase your risk for serious side effects.||
0226|105|I|This document does not contain all possible drug interactions.||
0226|106|I|Keep a list of all the products you use (including||
0226|107|I|prescription/nonprescription drugs and herbal products) and share||
0226|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
0226|109|I|the dosage of any medicines without your doctor's approval.||
0226|110|B|||
0226|111|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0226|112|O|has overdosed and has serious symptoms such as passing out or||
0226|113|O|trouble breathing, call 911. Otherwise, call a poison control||
0226|114|O|center right away. US residents can call 1-800-222-1222. Canada||
0226|115|O|residents can call 1-844-764-7669.||
0226|116|B|||
0226|117|N|NOTES:  Do not share this medication with others.||
0226|118|N|   This medication has been prescribed for your current condition||
0226|119|N|only. Do not use it later for another skin condition unless told||
0226|120|N|to do so by your doctor. A different medication may be necessary||
0226|121|N|in that case.||
0226|122|N|   Before rinsing, it might be helpful to use a wet wipe to||
0226|123|N|remove extra medication.||
0226|124|B|||
0226|125|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0226|126|D|If it is near the time of the next dose, skip the missed dose.||
0226|127|D|Use your next dose at the regular time. Do not double the dose to||
0226|128|D|catch up.||
0226|129|B|||
0226|130|R|STORAGE:  Store at room temperature away from light. Keep all||
0226|131|R|medications away from children and pets.||
0226|132|R|   Do not flush medications down the toilet or pour them into a||
0226|133|R|drain unless instructed to do so. Properly discard this product||
0226|134|R|when it is expired or no longer needed. Consult your pharmacist||
0226|135|R|or local waste disposal company.||
0226|136|B|||
0226|137|A|Information last revised September 2024.||
0226|138|A|Copyright(c) 2025 First Databank, Inc.||
0226|139|B|||
0227|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0227|002|Z|does NOT have all possible information about this product. This||
0227|003|Z|information does not assure that this product is safe, effective,||
0227|004|Z|or appropriate for you. This information is not individual||
0227|005|Z|medical advice and does not substitute for the advice of your||
0227|006|Z|health care professional. Always ask your health care||
0227|007|Z|professional for complete information about this product and your||
0227|008|Z|specific health needs.||
0227|009|B|||
0227|010|T|POTASSIUM CITRATE/CITRIC ACID - ORAL||
0227|011|F|(poe-TAS-ee-um SI-trate/SIT-rik AS-id)||
0227|012|B|||
0227|013|C|COMMON BRAND NAME(S): Polycitra-K||
0227|014|B|||
0227|015|U|USES:  This medication is used to make the urine less acidic.||
0227|016|U|This effect helps the kidneys get rid of uric acid, thereby||
0227|017|U|helping to prevent gout and kidney stones. This medication can||
0227|018|U|also prevent and treat certain metabolic problems (acidosis)||
0227|019|U|caused by kidney disease.||
0227|020|U|   Citric acid and citrate salts (which contain potassium and||
0227|021|U|sodium) belong to a class of drugs known as urinary alkalinizers.||
0227|022|U|If you have a condition that requires you to limit your intake of||
0227|023|U|potassium and sodium, your doctor may direct you to take a||
0227|024|U|product that is lower in potassium and sodium.||
0227|025|B|||
0227|026|H|HOW TO USE:  Take this medication by mouth as directed by your||
0227|027|H|doctor, usually 4 times a day after meals and at bedtime. To help||
0227|028|H|prevent diarrhea, take each dose after a meal. To prevent stomach||
0227|029|H|upset/injury, mix your prescribed dose of medication in cold||
0227|030|H|water or juice as directed. Drink the entire mixture slowly. If||
0227|031|H|you still have stomach upset, mixing your dose in a larger amount||
0227|032|H|of liquid may help unless your doctor directs you otherwise. Ask||
0227|033|H|your doctor or pharmacist for further instructions.||
0227|034|H|   The liquid form of this medication must be mixed with at least||
0227|035|H|4 - 8 ounces (120 - 240 milliliters) of water before taking.||
0227|036|H|Shake the bottle well before each dose and carefully measure the||
0227|037|H|dose using a special measuring device/spoon. Do not use a||
0227|038|H|household spoon because you may not get the correct dose. If you||
0227|039|H|are using the powdered/crystal form of this medication, mix the||
0227|040|H|contents of the packet in at least 3/4 cup (6 ounces or 180||
0227|041|H|milliliters) of cool water or juice before taking.||
0227|042|H|   Refrigerating the mixture before drinking may improve the||
0227|043|H|taste. Drink more water or juice after taking this medication||
0227|044|H|unless otherwise directed by your doctor.||
0227|045|H|   Dosage is based on your medical condition and response to||
0227|046|H|treatment.||
0227|047|H|   Take this medication exactly as prescribed. Do not increase||
0227|048|H|your dose or take this more often without your doctor's approval.||
0227|049|H|Use this medication regularly to get the most benefit from it. To||
0227|050|H|help you remember, take it at the same times each day.||
0227|051|H|   While taking this medication, you may need to test the pH||
0227|052|H|(acidity) of your urine using special paper. The pH will help||
0227|053|H|determine the proper dose. Consult your doctor or pharmacist for||
0227|054|H|more information.||
0227|055|B|||
0227|056|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, and stomach pain may||
0227|057|S|occur. Mixing the medication with water or juice, taking it after||
0227|058|S|meals, and drinking more fluids will help prevent these side||
0227|059|S|effects. If any of these effects last or get worse, tell your||
0227|060|S|doctor or pharmacist promptly.||
0227|061|S|   Remember that this medication has been prescribed because your||
0227|062|S|doctor has judged that the benefit to you is greater than the||
0227|063|S|risk of side effects. Many people using this medication do not||
0227|064|S|have serious side effects.||
0227|065|S|   Tell your doctor right away if you have any serious side||
0227|066|S|effects, including: severe stomach/abdominal pain,||
0227|067|S|tingling/numbness of the hands/feet, weakness,||
0227|068|S|fast/slow/irregular heartbeat, mental/mood changes (such as||
0227|069|S|confusion, restlessness), muscle spasms, seizures,||
0227|070|S|bloody/black/tarry stools, vomit that looks like coffee grounds.||
0227|071|S|   A very serious allergic reaction to this drug is rare.||
0227|072|S|However, get medical help right away if you notice any symptoms||
0227|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0227|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0227|075|S|breathing.||
0227|076|S|   This is not a complete list of possible side effects. If you||
0227|077|S|notice other effects not listed above, contact your doctor or||
0227|078|S|pharmacist.||
0227|079|S|   In the US -||
0227|080|S|   Call your doctor for medical advice about side effects. You||
0227|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0227|082|S|www.fda.gov/medwatch.||
0227|083|S|   In Canada - Call your doctor for medical advice about side||
0227|084|S|effects. You may report side effects to Health Canada at||
0227|085|S|1-866-234-2345.||
0227|086|B|||
0227|087|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0227|088|P|pharmacist if you are allergic to it; or if you have any other||
0227|089|P|allergies. This product may contain inactive ingredients, which||
0227|090|P|can cause allergic reactions or other problems. Talk to your||
0227|091|P|pharmacist for more details.||
0227|092|P|   Before using this medication, tell your doctor or pharmacist||
0227|093|P|your medical history, especially of: underactive adrenal gland||
0227|094|P|(Addison's disease), heart disease (such as recent heart attack,||
0227|095|P|irregular heartbeat, heart failure), kidney disease,||
0227|096|P|potassium-restricted diet, high potassium levels, dehydration,||
0227|097|P|low calcium levels, stomach/gut problems (such as peptic ulcers,||
0227|098|P|irritable bowel).||
0227|099|P|   Liquid forms of this product may contain sugar. Caution is||
0227|100|P|advised if you have diabetes. Ask your doctor or pharmacist about||
0227|101|P|using this product safely.||
0227|102|P|   During pregnancy, this medication should be used only when||
0227|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
0227|104|P|   It is unknown if this drug passes into breast milk. Consult||
0227|105|P|your doctor before breastfeeding.||
0227|106|B|||
0227|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0227|108|I|medications work or increase your risk for serious side effects.||
0227|109|I|This document does not contain all possible drug interactions.||
0227|110|I|Keep a list of all the products you use (including||
0227|111|I|prescription/nonprescription drugs and herbal products) and share||
0227|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
0227|113|I|the dosage of any medicines without your doctor's approval.||
0227|114|I|   Some products that may interact with this drug are: antacids||
0227|115|I|that contain aluminum, aspirin and other salicylates (such as||
0227|116|I|salsalate), certain blood pressure medications (including ACE||
0227|117|I|inhibitors such as lisinopril, angiotensin blockers such as||
0227|118|I|losartan), drospirenone, eplerenone, certain heart medications||
0227|119|I|(such as quinidine, digoxin), lithium, potassium supplements,||
0227|120|I|certain "water pills" (potassium-sparing diuretics such as||
0227|121|I|amiloride, spironolactone, triamterene).||
0227|122|I|   If your doctor has told you to take low-dose aspirin to||
0227|123|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0227|124|I|you should keep taking the aspirin unless your doctor tells you||
0227|125|I|not to. Ask your doctor or pharmacist for more details.||
0227|126|B|||
0227|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0227|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0227|129|O|poison control center right away. US residents can call||
0227|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0227|131|O|Symptoms of overdose may include: slow heartbeat, muscle spasms,||
0227|132|O|seizures.||
0227|133|B|||
0227|134|N|NOTES:  Do not share this medication with others.||
0227|135|N|   Lab and/or medical tests (such as potassium levels) should be||
0227|136|N|done while you are taking this medication. Keep all medical and||
0227|137|N|lab appointments. Consult your doctor for more details.||
0227|138|B|||
0227|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0227|140|D|remember. If it is near the time of the next dose, skip the||
0227|141|D|missed dose. Take your next dose at the regular time. Do not||
0227|142|D|double the dose to catch up.||
0227|143|B|||
0227|144|R|STORAGE:  Store at room temperature away from heat, light, and||
0227|145|R|moisture. Do not freeze. Do not store in the bathroom. Keep all||
0227|146|R|medications away from children and pets.||
0227|147|R|   Do not flush medications down the toilet or pour them into a||
0227|148|R|drain unless instructed to do so. Properly discard this product||
0227|149|R|when it is expired or no longer needed. Consult your pharmacist||
0227|150|R|or local waste disposal company.||
0227|151|B|||
0227|152|A|Information last revised May 2024.||
0227|153|A|Copyright(c) 2025 First Databank, Inc.||
0227|154|B|||
0229|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0229|002|Z|does NOT have all possible information about this product. This||
0229|003|Z|information does not assure that this product is safe, effective,||
0229|004|Z|or appropriate for you. This information is not individual||
0229|005|Z|medical advice and does not substitute for the advice of your||
0229|006|Z|health care professional. Always ask your health care||
0229|007|Z|professional for complete information about this product and your||
0229|008|Z|specific health needs.||
0229|009|B|||
0229|010|T|STRONTIUM-89 CHLORIDE - INJECTION||
0229|011|F|(STRON-shee-um KLOR-ide)||
0229|012|B|||
0229|013|C|COMMON BRAND NAME(S): Metastron||
0229|014|B|||
0229|015|U|USES:  This medication is used to relieve bone pain in people||
0229|016|U|with bone cancer. Strontium-89 is a radioactive drug. It works by||
0229|017|U|building up in certain cancer cells and causing them to die.||
0229|018|B|||
0229|019|H|HOW TO USE:  This medication is given by injection into a vein by||
0229|020|H|a health care professional. It is injected slowly into a vein||
0229|021|H|over 1 to 2 minutes. The effects of this medication should last||
0229|022|H|for several months. If needed, repeat doses are given as directed||
0229|023|H|by your doctor, usually after 3 months.||
0229|024|H|   After receiving this medication, follow your doctor's||
0229|025|H|instructions on how to reduce radiation exposure to others.||
0229|026|H|   The dosage is based on your medical condition, weight, lab||
0229|027|H|tests, and response to treatment.||
0229|028|H|   For the first few days after the injection, you may experience||
0229|029|H|a slight increase in pain. After 1 to 2 weeks, the pain should||
0229|030|H|decrease for several months. Tell your doctor if your pain does||
0229|031|H|not get better or if it gets worse.||
0229|032|B|||
0229|033|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0229|034|S|because your doctor has judged that the benefit to you is greater||
0229|035|S|than the risk of side effects. Many people using this medication||
0229|036|S|do not have serious side effects.||
0229|037|S|   Tell your doctor right away if you have any serious side||
0229|038|S|effects, including: easy bruising/bleeding.||
0229|039|S|   This medication may lower your ability to fight infections.||
0229|040|S|This may make you more likely to get a serious (rarely fatal)||
0229|041|S|infection or make any infection you have worse. Tell your doctor||
0229|042|S|right away if you have any signs of infection (such as sore||
0229|043|S|throat that doesn't go away, fever, chills).||
0229|044|S|   A very serious allergic reaction to this drug is rare.||
0229|045|S|However, get medical help right away if you notice any symptoms||
0229|046|S|of a serious allergic reaction, including: rash, itching/swelling||
0229|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0229|048|S|breathing.||
0229|049|S|   This is not a complete list of possible side effects. If you||
0229|050|S|notice other effects not listed above, contact your doctor or||
0229|051|S|pharmacist.||
0229|052|S|   In the US -||
0229|053|S|   Call your doctor for medical advice about side effects. You||
0229|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0229|055|S|www.fda.gov/medwatch.||
0229|056|S|   In Canada - Call your doctor for medical advice about side||
0229|057|S|effects. You may report side effects to Health Canada at||
0229|058|S|1-866-234-2345.||
0229|059|B|||
0229|060|P|PRECAUTIONS:  Before using strontium-89, tell your doctor or||
0229|061|P|pharmacist if you are allergic to it; or if you have any other||
0229|062|P|allergies. This product may contain inactive ingredients, which||
0229|063|P|can cause allergic reactions or other problems. Talk to your||
0229|064|P|pharmacist for more details.||
0229|065|P|   Before using this medication, tell your doctor or pharmacist||
0229|066|P|your medical history, especially of: blood/bone marrow problems||
0229|067|P|(such as low red/white blood cells and platelets), kidney||
0229|068|P|problems.||
0229|069|P|   This medication can make you more likely to get infections or||
0229|070|P|may make current infections worse. Stay away from anyone who has||
0229|071|P|an infection that may easily spread (such as chickenpox,||
0229|072|P|COVID-19, measles, flu). Talk to your doctor if you have been||
0229|073|P|exposed to an infection or for more details.||
0229|074|P|   Tell your health care professional that you are using||
0229|075|P|strontium-89 before having any immunizations/vaccinations. Avoid||
0229|076|P|contact with people who have recently received live vaccines||
0229|077|P|(such as flu vaccine inhaled through the nose).||
0229|078|P|   To lower the chance of getting cut, bruised, or injured, use||
0229|079|P|caution with sharp objects like razors and nail cutters, and||
0229|080|P|avoid activities such as contact sports.||
0229|081|P|   Before having surgery, tell your doctor or dentist about all||
0229|082|P|the products you use (including prescription drugs,||
0229|083|P|nonprescription drugs, and herbal products).||
0229|084|P|   Tell your doctor if you are pregnant or plan to become||
0229|085|P|pregnant. You should not become pregnant while using||
0229|086|P|strontium-89. Strontium-89 may harm an unborn baby. Your doctor||
0229|087|P|should order a pregnancy test before you start this medication.||
0229|088|P|If you become pregnant, talk to your doctor right away about the||
0229|089|P|risks and benefits of this medication.||
0229|090|P|   It is unknown if this drug passes into breast milk. Because of||
0229|091|P|the possible risk to the infant, breastfeeding is not recommended||
0229|092|P|while using this drug. Consult your doctor before breastfeeding.||
0229|093|B|||
0229|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0229|095|I|medications work or increase your risk for serious side effects.||
0229|096|I|This document does not contain all possible drug interactions.||
0229|097|I|Keep a list of all the products you use (including||
0229|098|I|prescription/nonprescription drugs and herbal products) and share||
0229|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
0229|100|I|the dosage of any medicines without your doctor's approval.||
0229|101|B|||
0229|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0229|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0229|104|O|poison control center right away. US residents can call||
0229|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0229|106|B|||
0229|107|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0229|108|N|kidney function) should be done while you are using this||
0229|109|N|medication. Keep all medical and lab appointments.||
0229|110|B|||
0229|111|D|MISSED DOSE:  It is important to get each dose of this medication||
0229|112|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0229|113|D|right away for a new dosing schedule. Do not double the dose to||
0229|114|D|catch up.||
0229|115|B|||
0229|116|R|STORAGE:  Not applicable. This medication is given in a hospital||
0229|117|R|or clinic or doctor's office and will not be stored at home.||
0229|118|B|||
0229|119|A|Information last revised April 2025.||
0229|120|A|Copyright(c) 2025 First Databank, Inc.||
0229|121|B|||
0230|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0230|002|Z|does NOT have all possible information about this product. This||
0230|003|Z|information does not assure that this product is safe, effective,||
0230|004|Z|or appropriate for you. This information is not individual||
0230|005|Z|medical advice and does not substitute for the advice of your||
0230|006|Z|health care professional. Always ask your health care||
0230|007|Z|professional for complete information about this product and your||
0230|008|Z|specific health needs.||
0230|009|B|||
0230|010|T|CALCIPOTRIENE - TOPICAL||
0230|011|F|(KAL-si-poe-TRYE-een)||
0230|012|B|||
0230|013|C|COMMON BRAND NAME(S): Dovonex, Sorilux||
0230|014|B|||
0230|015|U|USES:  This medication is used to treat psoriasis. Calcipotriene||
0230|016|U|is a form of vitamin D. It works by slowing down the growth of||
0230|017|U|skin cells.||
0230|018|B|||
0230|019|H|HOW TO USE:  Use this medication on the skin only. Apply a thin||
0230|020|H|layer of the medication as directed by your doctor to the||
0230|021|H|affected area and gently rub in, usually once or twice daily for||
0230|022|H|the ointment or twice daily for the cream or the foam. Wash your||
0230|023|H|hands after using, unless you are using this medication to treat||
0230|024|H|the hands. Do not apply the medication on the face, in the eyes,||
0230|025|H|nose, or mouth, or inside the vagina. If you do get the||
0230|026|H|medication in those areas, flush with plenty of water.||
0230|027|H|   Do not apply more often or use longer than prescribed. This||
0230|028|H|may increase the risk of side effects.||
0230|029|H|   Use this medication regularly to get the most benefit from it.||
0230|030|H|To help you remember, use it at the same time(s) each day.||
0230|031|H|   The foam is flammable until dry. Avoid smoking or being near||
0230|032|H|open flames while using the foam and until the medication has||
0230|033|H|dried.||
0230|034|H|   Tell your doctor if your condition does not get better or if||
0230|035|H|it gets worse. You should usually begin to see an improvement in||
0230|036|H|your skin condition after 2 weeks of treatment.||
0230|037|B|||
0230|038|S|SIDE EFFECTS:  Burning, itching, rash, irritation, redness, dry||
0230|039|S|skin, or peeling at the application site may occur. If any of||
0230|040|S|these effects last or get worse, tell your doctor or pharmacist||
0230|041|S|promptly.||
0230|042|S|   Remember that this medication has been prescribed because your||
0230|043|S|doctor has judged that the benefit to you is greater than the||
0230|044|S|risk of side effects. Many people using this medication do not||
0230|045|S|have serious side effects.||
0230|046|S|   Tell your doctor right away if you have any serious side||
0230|047|S|effects, including: skin thinning/discoloration, stretch marks,||
0230|048|S|small red bumps on the skin (folliculitis), unusual tiredness,||
0230|049|S|mental/mood changes, unexplained constipation.||
0230|050|S|   A very serious allergic reaction to this drug is rare.||
0230|051|S|However, get medical help right away if you notice any symptoms||
0230|052|S|of a serious allergic reaction, including: rash, itching/swelling||
0230|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0230|054|S|breathing.||
0230|055|S|   This is not a complete list of possible side effects. If you||
0230|056|S|notice other effects not listed above, contact your doctor or||
0230|057|S|pharmacist.||
0230|058|S|   In the US -||
0230|059|S|   Call your doctor for medical advice about side effects. You||
0230|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0230|061|S|www.fda.gov/medwatch.||
0230|062|S|   In Canada - Call your doctor for medical advice about side||
0230|063|S|effects. You may report side effects to Health Canada at||
0230|064|S|1-866-234-2345.||
0230|065|B|||
0230|066|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0230|067|P|pharmacist if you are allergic to it; or if you have any other||
0230|068|P|allergies. This product may contain inactive ingredients, which||
0230|069|P|can cause allergic reactions or other problems. Talk to your||
0230|070|P|pharmacist for more details.||
0230|071|P|   Before using this medication, tell your doctor or pharmacist||
0230|072|P|your medical history, especially of: high calcium/vitamin D||
0230|073|P|levels (hypercalcemia/hypervitaminosis D).||
0230|074|P|   This medication may make you more sensitive to the sun. Limit||
0230|075|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0230|076|P|sunscreen and wear protective clothing when outdoors. Tell your||
0230|077|P|doctor right away if you get sunburned or have skin||
0230|078|P|blisters/redness. Your doctor may direct you to limit or avoid||
0230|079|P|phototherapy while you use this product. Ask your doctor for||
0230|080|P|details.||
0230|081|P|   Older adults may be more sensitive to the side effects of this||
0230|082|P|drug.||
0230|083|P|   During pregnancy, this medication should be used only when||
0230|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
0230|085|P|   It is unknown if this drug passes into breast milk. Consult||
0230|086|P|your doctor before breastfeeding.||
0230|087|B|||
0230|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0230|089|I|medications work or increase your risk for serious side effects.||
0230|090|I|This document does not contain all possible drug interactions.||
0230|091|I|Keep a list of all the products you use (including||
0230|092|I|prescription/nonprescription drugs and herbal products) and share||
0230|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
0230|094|I|the dosage of any medicines without your doctor's approval.||
0230|095|I|   Some products that may interact with this drug are: other||
0230|096|I|products containing vitamin D.||
0230|097|B|||
0230|098|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0230|099|O|has overdosed and has serious symptoms such as passing out or||
0230|100|O|trouble breathing, call 911. Otherwise, call a poison control||
0230|101|O|center right away. US residents can call 1-800-222-1222. Canada||
0230|102|O|residents can call 1-844-764-7669.||
0230|103|B|||
0230|104|N|NOTES:  Do not share this medication with others.||
0230|105|N|   Lab and/or medical tests (such as calcium levels) may be done||
0230|106|N|while you are using this medication. Keep all medical and lab||
0230|107|N|appointments. Consult your doctor for more details.||
0230|108|N|   This medication has been prescribed for your current condition||
0230|109|N|only. Do not use it later for another skin condition unless told||
0230|110|N|to do so by your doctor. A different medication may be necessary||
0230|111|N|in that case.||
0230|112|B|||
0230|113|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0230|114|D|If it is near the time of the next dose, skip the missed dose.||
0230|115|D|Use your next dose at the regular time. Do not double the dose to||
0230|116|D|catch up.||
0230|117|B|||
0230|118|R|STORAGE:  Store at room temperature. Do not freeze. Store the||
0230|119|R|foam away from direct sunlight. The foam is flammable. Keep it||
0230|120|R|away from heat and open flame. Do not puncture the foam can. Keep||
0230|121|R|all medications away from children and pets.||
0230|122|R|   Do not flush medications down the toilet or pour them into a||
0230|123|R|drain unless instructed to do so. Properly discard this product||
0230|124|R|when it is expired or no longer needed. Consult your pharmacist||
0230|125|R|or local waste disposal company.||
0230|126|B|||
0230|127|A|Information last revised July 2025.||
0230|128|A|Copyright(c) 2025 First Databank, Inc.||
0230|129|B|||
0232|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0232|002|Z|does NOT have all possible information about this product. This||
0232|003|Z|information does not assure that this product is safe, effective,||
0232|004|Z|or appropriate for you. This information is not individual||
0232|005|Z|medical advice and does not substitute for the advice of your||
0232|006|Z|health care professional. Always ask your health care||
0232|007|Z|professional for complete information about this product and your||
0232|008|Z|specific health needs.||
0232|009|B|||
0232|010|T|MESNA - INJECTION||
0232|011|F|(MES-na)||
0232|012|B|||
0232|013|C|COMMON BRAND NAME(S): Mesnex||
0232|014|B|||
0232|015|U|USES:  This medication is used to reduce the risk of bleeding in||
0232|016|U|the bladder (hemorrhagic cystitis), which is a very serious side||
0232|017|U|effect of treatment with a cancer chemotherapy drug called||
0232|018|U|ifosfamide. Mesna helps to protect the lining of the bladder||
0232|019|U|against damage from ifosfamide. The body breaks down ifosfamide||
0232|020|U|to form a product that can harm the bladder, and mesna works by||
0232|021|U|making this product less harmful. However, mesna does not change||
0232|022|U|ifosfamide's anti-cancer effects.||
0232|023|B|||
0232|024|V|OTHER USES:  This section contains uses of this drug that are not||
0232|025|V|listed in the approved professional labeling for the drug but||
0232|026|V|that may be prescribed by your health care professional. Use this||
0232|027|V|drug for a condition that is listed in this section only if it||
0232|028|V|has been so prescribed by your health care professional.||
0232|029|V|   This drug may also be used to reduce the risk of bleeding in||
0232|030|V|the bladder caused by another cancer chemotherapy drug called||
0232|031|V|cyclophosphamide.||
0232|032|B|||
0232|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0232|034|H|from your pharmacist before you start using mesna and with each||
0232|035|H|treatment cycle. If you have any questions, ask your doctor or||
0232|036|H|pharmacist.||
0232|037|H|   This medication is given by injection into a vein by a health||
0232|038|H|care professional. The dosage is based on your body size and your||
0232|039|H|dose of ifosfamide (or cyclophosphamide).||
0232|040|H|   While using this medication, drink at least a quart (4 cups or||
0232|041|H|1 liter) of liquid each day unless directed otherwise by your||
0232|042|H|doctor. Doing so will also help to reduce the bladder side||
0232|043|H|effects from the chemotherapy drug.||
0232|044|H|   Mesna is very effective in reducing the risk of hemorrhagic||
0232|045|H|cystitis in most patients. However, it may not work in a small||
0232|046|H|number of patients. Tell your doctor right away if you notice||
0232|047|H|that your urine is pink, red, or bloody.||
0232|048|B|||
0232|049|S|SIDE EFFECTS:  Headache, redness/pain/swelling at the injection||
0232|050|S|site, flushing, dizziness, drowsiness, nausea, vomiting, loss of||
0232|051|S|appetite, diarrhea, constipation, sensitive skin, or flu-like||
0232|052|S|symptoms (such as sore throat, cough, body aches) may occur. If||
0232|053|S|any of these effects last or get worse, tell your doctor or||
0232|054|S|pharmacist promptly.||
0232|055|S|   Remember that this medication has been prescribed because your||
0232|056|S|doctor has judged that the benefit to you is greater than the||
0232|057|S|risk of side effects. Many people using this medication do not||
0232|058|S|have serious side effects.||
0232|059|S|   Tell your doctor right away if you have any serious side||
0232|060|S|effects, including: fast heartbeat, swelling ankles/feet, muscle||
0232|061|S|weakness.||
0232|062|S|   Get medical help right away if you have any very serious side||
0232|063|S|effects, including: chest pain.||
0232|064|S|   A very serious allergic reaction to this drug is rare.||
0232|065|S|However, get medical help right away if you notice any symptoms||
0232|066|S|of a serious allergic reaction, including: fever, swollen lymph||
0232|067|S|nodes, rash, itching/swelling (especially of the||
0232|068|S|face/tongue/throat), severe dizziness, trouble breathing.||
0232|069|S|   This is not a complete list of possible side effects. If you||
0232|070|S|notice other effects not listed above, contact your doctor or||
0232|071|S|pharmacist.||
0232|072|S|   In the US -||
0232|073|S|   Call your doctor for medical advice about side effects. You||
0232|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0232|075|S|www.fda.gov/medwatch.||
0232|076|S|   In Canada - Call your doctor for medical advice about side||
0232|077|S|effects. You may report side effects to Health Canada at||
0232|078|S|1-866-234-2345.||
0232|079|B|||
0232|080|P|PRECAUTIONS:  Before using mesna, tell your doctor or pharmacist||
0232|081|P|if you are allergic to it; or if you have any other allergies.||
0232|082|P|This product may contain inactive ingredients (such as benzyl||
0232|083|P|alcohol found in some brands), which can cause allergic reactions||
0232|084|P|or other problems. Talk to your pharmacist for more details.||
0232|085|P|   Before using this medication, tell your doctor or pharmacist||
0232|086|P|your medical history.||
0232|087|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0232|088|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0232|089|P|machinery, or do anything that needs alertness until you can do||
0232|090|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0232|091|P|are using marijuana (cannabis).||
0232|092|P|   Before having surgery, tell your doctor or dentist about all||
0232|093|P|the products you use (including prescription drugs,||
0232|094|P|nonprescription drugs, and herbal products).||
0232|095|P|   Tell your doctor if you are pregnant or plan to become||
0232|096|P|pregnant. Since mesna is used with a chemotherapy drug, you||
0232|097|P|should not become pregnant during treatment because the||
0232|098|P|chemotherapy drug may harm an unborn baby. Ask about reliable||
0232|099|P|forms of birth control while using this medication and||
0232|100|P|chemotherapy. If you become pregnant, talk to your doctor right||
0232|101|P|away about the risks and benefits of mesna and the chemotherapy||
0232|102|P|drug.||
0232|103|P|   It is unknown if mesna passes into breast milk. Since mesna is||
0232|104|P|given with a chemotherapy drug, breastfeeding is not recommended||
0232|105|P|while using this medication and for 1 week after the last dose of||
0232|106|P|mesna or the chemotherapy drug. Consult your doctor before||
0232|107|P|breastfeeding.||
0232|108|B|||
0232|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0232|110|I|medications work or increase your risk for serious side effects.||
0232|111|I|This document does not contain all possible drug interactions.||
0232|112|I|Keep a list of all the products you use (including||
0232|113|I|prescription/nonprescription drugs and herbal products) and share||
0232|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
0232|115|I|the dosage of any medicines without your doctor's approval.||
0232|116|I|   This medication may interfere with certain lab tests (such as||
0232|117|I|urine ketone test), possibly causing false test results. Make||
0232|118|I|sure lab personnel and all your doctors know you use this drug.||
0232|119|B|||
0232|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0232|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0232|122|O|poison control center right away. US residents can call||
0232|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0232|124|B|||
0232|125|N|NOTES:  This medication does not protect you from other side||
0232|126|N|effects of ifosfamide. Consult your doctor or pharmacist for more||
0232|127|N|information on how to manage other side effects.||
0232|128|N|   Small amounts of blood in the urine cannot be seen without a||
0232|129|N|microscope. A lab test to check for blood in your urine should be||
0232|130|N|done before each dose of ifosfamide. Keep all medical and lab||
0232|131|N|appointments. Consult your doctor for more details.||
0232|132|B|||
0232|133|D|MISSED DOSE:  It is important to get each dose of this medication||
0232|134|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0232|135|D|right away for a new dosing schedule.||
0232|136|B|||
0232|137|R|STORAGE:  Consult the product instructions and your pharmacist||
0232|138|R|for storage details. Keep all medications away from children and||
0232|139|R|pets.||
0232|140|R|   Do not flush medications down the toilet or pour them into a||
0232|141|R|drain unless instructed to do so. Properly discard this product||
0232|142|R|when it is expired or no longer needed. Consult your pharmacist||
0232|143|R|or local waste disposal company.||
0232|144|B|||
0232|145|A|Information last revised May 2024.||
0232|146|A|Copyright(c) 2025 First Databank, Inc.||
0232|147|B|||
0233|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0233|002|Z|does NOT have all possible information about this product. This||
0233|003|Z|information does not assure that this product is safe, effective,||
0233|004|Z|or appropriate for you. This information is not individual||
0233|005|Z|medical advice and does not substitute for the advice of your||
0233|006|Z|health care professional. Always ask your health care||
0233|007|Z|professional for complete information about this product and your||
0233|008|Z|specific health needs.||
0233|009|B|||
0233|010|T|OCTREOTIDE - INJECTION||
0233|011|F|(ok-TREE-oh-tide)||
0233|012|B|||
0233|013|C|COMMON BRAND NAME(S): Sandostatin||
0233|014|B|||
0233|015|U|USES:  Octreotide is used to treat severe watery diarrhea and||
0233|016|U|sudden reddening of the face and neck caused by certain types of||
0233|017|U|tumors (such as carcinoid tumors, vasoactive intestinal peptide||
0233|018|U|tumors) that are found usually in the intestines and pancreas.||
0233|019|U|The symptoms occur when these tumors make too much of certain||
0233|020|U|natural substances (hormones). This medication works by blocking||
0233|021|U|the production of these hormones. By decreasing watery diarrhea,||
0233|022|U|octreotide helps to reduce the loss of body fluids and minerals.||
0233|023|U|   Octreotide is also used to treat a certain condition||
0233|024|U|(acromegaly) that occurs when the body makes too much of a||
0233|025|U|certain natural substance called growth hormone. Treating||
0233|026|U|acromegaly helps reduce the risk of serious problems such as||
0233|027|U|diabetes and heart disease. Octreotide works by decreasing how||
0233|028|U|much growth hormone your body makes.||
0233|029|U|   This drug is not a cure for these conditions. This medication||
0233|030|U|is usually used with other treatment (such as surgery, radiation,||
0233|031|U|other drugs).||
0233|032|B|||
0233|033|H|HOW TO USE:  Inject this medication under the skin as directed by||
0233|034|H|your doctor, usually 2 to 3 times a day. Depending on your||
0233|035|H|condition, it may be given by injection into a vein by a health||
0233|036|H|care professional. The dosage is based on your medical condition||
0233|037|H|and response to treatment.||
0233|038|H|   If you are injecting this medication under the skin at home,||
0233|039|H|learn all preparation and usage instructions from your health||
0233|040|H|care professional. Before using, check this product for particles||
0233|041|H|or discoloration. If either is present, do not use the liquid.||
0233|042|H|Before injecting each dose, clean the skin you are going to||
0233|043|H|inject into (the injection site) with rubbing alcohol. Change the||
0233|044|H|injection site each time to lessen injury under the skin. To||
0233|045|H|lessen bruising, do not rub the injection site after a shot.||
0233|046|H|Learn how to store and discard medical supplies safely.||
0233|047|H|   Use this medication regularly to get the most benefit from it.||
0233|048|H|To help you remember, use it at the same times each day.||
0233|049|H|   Tell your doctor if your condition does not get better or if||
0233|050|H|it gets worse.||
0233|051|B|||
0233|052|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach upset, gas,||
0233|053|S|bloating, dizziness, or headache may occur. Pain and irritation||
0233|054|S|at the injection site may also occur. If any of these effects||
0233|055|S|last or get worse, tell your doctor or pharmacist promptly.||
0233|056|S|   Remember that this medication has been prescribed because your||
0233|057|S|doctor has judged that the benefit to you is greater than the||
0233|058|S|risk of side effects. Many people using this medication do not||
0233|059|S|have serious side effects.||
0233|060|S|   Tell your doctor right away if you have any serious side||
0233|061|S|effects, including: signs of gallbladder/liver problems (such as||
0233|062|S|fever, nausea/vomiting that doesn't stop, loss of appetite,||
0233|063|S|stomach/abdominal pain, yellowing eyes/skin, dark urine,||
0233|064|S|unexplained pain in the back/right shoulder), signs of||
0233|065|S|underactive thyroid (such as unexplained weight gain, cold||
0233|066|S|intolerance, severe constipation, unusual tiredness,||
0233|067|S|growth/lump/swelling on the front of the neck),||
0233|068|S|slow/fast/irregular heartbeat, weight loss, change in stool||
0233|069|S|color.||
0233|070|S|   This medication may cause changes in blood sugar, especially||
0233|071|S|if you have diabetes. Symptoms of high blood sugar include||
0233|072|S|increased thirst and urination. Symptoms of low blood sugar||
0233|073|S|include sudden sweating, shaking, fast heartbeat, hunger, blurred||
0233|074|S|vision, dizziness, or tingling hands/feet. Tell your doctor right||
0233|075|S|away if you experience symptoms of high or low blood sugar while||
0233|076|S|using this medication. If you already have diabetes, check your||
0233|077|S|blood sugar regularly as directed and share the results with your||
0233|078|S|doctor. Your doctor may need to adjust your diabetes medication,||
0233|079|S|exercise program, or diet.||
0233|080|S|   A very serious allergic reaction to this drug is rare.||
0233|081|S|However, get medical help right away if you notice any symptoms||
0233|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0233|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0233|084|S|breathing.||
0233|085|S|   This is not a complete list of possible side effects. If you||
0233|086|S|notice other effects not listed above, contact your doctor or||
0233|087|S|pharmacist.||
0233|088|S|   In the US -||
0233|089|S|   Call your doctor for medical advice about side effects. You||
0233|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0233|091|S|www.fda.gov/medwatch.||
0233|092|S|   In Canada - Call your doctor for medical advice about side||
0233|093|S|effects. You may report side effects to Health Canada at||
0233|094|S|1-866-234-2345.||
0233|095|B|||
0233|096|P|PRECAUTIONS:  Before using octreotide, tell your doctor or||
0233|097|P|pharmacist if you are allergic to it; or if you have any other||
0233|098|P|allergies. This product may contain inactive ingredients, which||
0233|099|P|can cause allergic reactions or other problems. Talk to your||
0233|100|P|pharmacist for more details.||
0233|101|P|   Before using this medication, tell your doctor or pharmacist||
0233|102|P|your medical history, especially of: kidney disease, liver||
0233|103|P|disease, diabetes, thyroid problems, gallbladder problems (such||
0233|104|P|as gallstones), heart problems (such as heart failure), nutrition||
0233|105|P|problems (such as decreased fat absorption, vitamin B12||
0233|106|P|deficiency).||
0233|107|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0233|108|P|can make you more dizzy. Do not drive, use machinery, or do||
0233|109|P|anything that needs alertness until you can do it safely. Limit||
0233|110|P|alcoholic beverages. Talk to your doctor if you are using||
0233|111|P|marijuana (cannabis).||
0233|112|P|   Before having surgery, tell your doctor or dentist about all||
0233|113|P|the products you use (including prescription drugs,||
0233|114|P|nonprescription drugs, and herbal products).||
0233|115|P|   If used for a long time (such as longer than 1 year), this||
0233|116|P|medication may slow a child's growth rate. However, the growth||
0233|117|P|rate catches up after treatment with the drug is stopped. Consult||
0233|118|P|your doctor for more information.||
0233|119|P|   Treatment with this medication may improve fertility in women||
0233|120|P|and may lead to unintended pregnancy. Ask your doctor for more||
0233|121|P|details.||
0233|122|P|   During pregnancy, this medication should be used only when||
0233|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
0233|124|P|   It is unknown if this medication passes into breast milk.||
0233|125|P|Consult your doctor before breastfeeding.||
0233|126|B|||
0233|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0233|128|I|medications work or increase your risk for serious side effects.||
0233|129|I|This document does not contain all possible drug interactions.||
0233|130|I|Keep a list of all the products you use (such as||
0233|131|I|prescription/nonprescription drugs and herbal products) and share||
0233|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
0233|133|I|the dosage of any medicines without your doctor's approval.||
0233|134|B|||
0233|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0233|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0233|137|O|poison control center right away. US residents can call||
0233|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0233|139|B|||
0233|140|N|NOTES:  Do not share this medication with others.||
0233|141|N|   Lab and/or medical tests (such as blood sugar, thyroid||
0233|142|N|function, hormone levels, vitamin B12 levels) should be done||
0233|143|N|before you start using this medication and while you are using||
0233|144|N|it. Keep all medical and lab appointments. Consult your doctor||
0233|145|N|for more details.||
0233|146|B|||
0233|147|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0233|148|D|If it is near the time of the next dose, skip the missed dose.||
0233|149|D|Use your next dose at the regular time. Do not double the dose to||
0233|150|D|catch up.||
0233|151|B|||
0233|152|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
0233|153|R|medication in the original carton to protect from light. This||
0233|154|R|medication may also be stored at room temperature if needed. If||
0233|155|R|the medication is stored at room temperature, discard after 2||
0233|156|R|weeks. Multi-use vials should be discarded 2 weeks after opening.||
0233|157|R|Ampules should be opened just before each dose, and any unused||
0233|158|R|portion should be discarded. Keep all medications away from||
0233|159|R|children and pets.||
0233|160|R|   Do not flush medications down the toilet or pour them into a||
0233|161|R|drain unless instructed to do so. Properly discard this product||
0233|162|R|when it is expired or no longer needed. Consult your pharmacist||
0233|163|R|or local waste disposal company.||
0233|164|B|||
0233|165|A|Information last revised October 2025.||
0233|166|A|Copyright(c) 2025 First Databank, Inc.||
0233|167|B|||
0234|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0234|002|Z|does NOT have all possible information about this product. This||
0234|003|Z|information does not assure that this product is safe, effective,||
0234|004|Z|or appropriate for you. This information is not individual||
0234|005|Z|medical advice and does not substitute for the advice of your||
0234|006|Z|health care professional. Always ask your health care||
0234|007|Z|professional for complete information about this product and your||
0234|008|Z|specific health needs.||
0234|009|B|||
0234|010|T|GLUCAGON - INJECTION||
0234|011|F|(GLOO-ka-gon)||
0234|012|B|||
0234|013|C|COMMON BRAND NAME(S): Glucagon, Glucagon Emergency Kit||
0234|014|B|||
0234|015|U|USES:  This medication is the same as your body's own glucagon, a||
0234|016|U|natural substance that raises blood sugar by causing the body to||
0234|017|U|release sugar stored in the liver. It is used to treat very low||
0234|018|U|blood sugar (hypoglycemia) that may cause you to need help from||
0234|019|U|others. To be ready ahead of time, make sure a family member or||
0234|020|U|caregiver knows where you keep this medication and how to use it.||
0234|021|U|   Glucagon may also be used before certain X-ray procedures of||
0234|022|U|the gut. It slows down movement of the stomach, intestines, and||
0234|023|U|colon, which may help make the X-ray more clear.||
0234|024|B|||
0234|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
0234|026|H|Instructions for Use Leaflet provided by your pharmacist when you||
0234|027|H|get this medication and each time you get a refill. If you have||
0234|028|H|any questions, ask your doctor or pharmacist.||
0234|029|H|   An episode of very low blood sugar should be treated right||
0234|030|H|away to prevent serious effects (such as brain damage). Be sure||
0234|031|H|to keep this medication handy in case it is needed. You and your||
0234|032|H|caregiver must learn ahead of time how to properly give this||
0234|033|H|medication. Caregivers should also know the symptoms of low blood||
0234|034|H|sugar (see also Precautions section).||
0234|035|H|    Before using, check this product for particles or||
0234|036|H|discoloration. If either is present, do not use the liquid. Learn||
0234|037|H|how to store and discard medical supplies safely.||
0234|038|H|   Inject this medication into a muscle or under the skin as||
0234|039|H|directed by the doctor. The dosage is based on your age.||
0234|040|H|Children's dosage is also based on weight. After giving this||
0234|041|H|medication, get medical help right away.||
0234|042|H|   If the person is unconscious, turn the person on their side to||
0234|043|H|prevent choking in case they vomit. If the person does not wake||
0234|044|H|up after 15 minutes, another dose may be given, if available.||
0234|045|H|   When the person wakes up and is able to swallow, give them a||
0234|046|H|quick sugar source (such as glucose tablets, juice). Glucagon||
0234|047|H|only works for a short time, and low blood sugar may return. Keep||
0234|048|H|the blood sugar level up by eating snacks such as crackers,||
0234|049|H|cheese, a meat sandwich, or milk.||
0234|050|H|   Always call your doctor right away when an episode of very low||
0234|051|H|blood sugar has happened. You may need more medical treatment, or||
0234|052|H|your insulin dose and diet may need to be adjusted.||
0234|053|B|||
0234|054|S|SIDE EFFECTS:  Nausea, vomiting, or headache may occur.||
0234|055|S|Irritation, redness, or swelling at the injection site may also||
0234|056|S|occur. If any of these effects last or get worse, tell your||
0234|057|S|doctor or pharmacist promptly.||
0234|058|S|   Remember that this medication has been prescribed because your||
0234|059|S|doctor has judged that the benefit to you is greater than the||
0234|060|S|risk of side effects. Many people using this medication do not||
0234|061|S|have serious side effects.||
0234|062|S|   Tell your doctor right away if you have any serious side||
0234|063|S|effects, including: fast/pounding heartbeat.||
0234|064|S|   A very serious allergic reaction to this drug is rare.||
0234|065|S|However, get medical help right away if you notice any symptoms||
0234|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0234|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0234|068|S|breathing.||
0234|069|S|   This is not a complete list of possible side effects. If you||
0234|070|S|notice other effects not listed above, contact your doctor or||
0234|071|S|pharmacist.||
0234|072|S|   In the US -||
0234|073|S|   Call your doctor for medical advice about side effects. You||
0234|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0234|075|S|www.fda.gov/medwatch.||
0234|076|S|   In Canada - Call your doctor for medical advice about side||
0234|077|S|effects. You may report side effects to Health Canada at||
0234|078|S|1-866-234-2345.||
0234|079|B|||
0234|080|P|PRECAUTIONS:  Before using glucagon, tell your doctor or||
0234|081|P|pharmacist if you are allergic to it; or if you have any other||
0234|082|P|allergies. This product may contain inactive ingredients (such as||
0234|083|P|latex used in some products), which can cause allergic reactions||
0234|084|P|or other problems. Talk to your pharmacist for more details.||
0234|085|P|   Before using this medication, tell your doctor or pharmacist||
0234|086|P|your medical history, especially of: tumor of the pancreas||
0234|087|P|(insulinoma), adrenal gland problems (such as Addison's disease,||
0234|088|P|pheochromocytoma), not eating/poor eating habits, frequent low||
0234|089|P|blood sugar.||
0234|090|P|   Low blood sugar (hypoglycemia) is more likely if you do not||
0234|091|P|consume enough calories from food, or if you do unusually heavy||
0234|092|P|exercise. Symptoms include sudden sweating, shaking, fast||
0234|093|P|heartbeat, hunger, blurred vision, dizziness, or tingling||
0234|094|P|hands/feet. It is a good habit to carry glucose tablets or gel to||
0234|095|P|treat low blood sugar. If you don't have these reliable forms of||
0234|096|P|glucose, rapidly raise your blood sugar by eating a quick source||
0234|097|P|of sugar such as table sugar, honey, or candy, or drink fruit||
0234|098|P|juice or non-diet soda. Tell your doctor right away about the||
0234|099|P|reaction and the use of this product. To help prevent low blood||
0234|100|P|sugar, eat meals on a regular schedule, and do not skip meals.||
0234|101|P|Check with your doctor or pharmacist to find out what you should||
0234|102|P|do if you miss a meal.||
0234|103|P|   Tell your doctor if you are pregnant before using this||
0234|104|P|medication.||
0234|105|P|   It is unknown if this drug passes into breast milk, but it is||
0234|106|P|unlikely to harm a nursing infant. Consult your doctor before||
0234|107|P|breastfeeding.||
0234|108|B|||
0234|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0234|110|I|medications work or increase your risk for serious side effects.||
0234|111|I|This document does not contain all possible drug interactions.||
0234|112|I|Keep a list of all the products you use (including||
0234|113|I|prescription/nonprescription drugs and herbal products) and share||
0234|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
0234|115|I|the dosage of any medicines without your doctor's approval.||
0234|116|B|||
0234|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0234|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0234|119|O|poison control center right away. US residents can call||
0234|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0234|121|B|||
0234|122|N|NOTES:  Do not share this product with others.||
0234|123|N|   Attend a diabetes education program to learn more about how to||
0234|124|N|manage your diabetes with medications, diet, exercise, and||
0234|125|N|regular medical exams.||
0234|126|N|   Learn the symptoms of high and low blood sugar and how to||
0234|127|N|treat low blood sugar. Check your blood sugar regularly as||
0234|128|N|directed.||
0234|129|B|||
0234|130|D|MISSED DOSE:  Not applicable.||
0234|131|B|||
0234|132|R|STORAGE:  Different brands of this medication have different||
0234|133|R|storage needs. Check the product package for instructions on how||
0234|134|R|to store your brand, or ask your pharmacist. Keep all medications||
0234|135|R|away from children and pets.||
0234|136|R|   Do not flush medications down the toilet or pour them into a||
0234|137|R|drain unless instructed to do so. Properly discard this product||
0234|138|R|when it is expired or no longer needed. Consult your pharmacist||
0234|139|R|or local waste disposal company.||
0234|140|B|||
0234|141|M|MEDICAL ALERT:  Your condition can cause complications in a||
0234|142|M|medical emergency. For information about enrolling in MedicAlert,||
0234|143|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0234|144|B|||
0234|145|A|Information last revised October 2024.||
0234|146|A|Copyright(c) 2025 First Databank, Inc.||
0234|147|B|||
0235|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0235|002|Z|does NOT have all possible information about this product. This||
0235|003|Z|information does not assure that this product is safe, effective,||
0235|004|Z|or appropriate for you. This information is not individual||
0235|005|Z|medical advice and does not substitute for the advice of your||
0235|006|Z|health care professional. Always ask your health care||
0235|007|Z|professional for complete information about this product and your||
0235|008|Z|specific health needs.||
0235|009|B|||
0235|010|T|OFLOXACIN SOLUTION - OPHTHALMIC||
0235|011|F|(oh-FLOX-a-sin)||
0235|012|B|||
0235|013|C|COMMON BRAND NAME(S): Ocuflox||
0235|014|B|||
0235|015|U|USES:  This medication is used to treat eye infections. Ofloxacin||
0235|016|U|belongs to a class of drugs called quinolone antibiotics. It||
0235|017|U|works by stopping the growth of bacteria.||
0235|018|U|   This medication treats only bacterial eye infections. It will||
0235|019|U|not work for other types of eye infections. Unnecessary use or||
0235|020|U|overuse of any antibiotic can lead to its decreased||
0235|021|U|effectiveness.||
0235|022|B|||
0235|023|H|HOW TO USE:  To apply eye drops, wash your hands first. To avoid||
0235|024|H|contamination, do not touch the dropper tip or let it touch your||
0235|025|H|eye or any other surface.||
0235|026|H|   Do not wear contact lenses while you are using this medicine.||
0235|027|H|Sterilize contact lenses according to manufacturer's directions||
0235|028|H|and check with your doctor before using them.||
0235|029|H|   Tilt your head back, look upward and pull down the lower||
0235|030|H|eyelid to make a pouch. Hold the dropper directly over the eye||
0235|031|H|and place one drop into the eye. Look downward and gently close||
0235|032|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0235|033|H|your eye (near the nose) and apply gentle pressure. This will||
0235|034|H|prevent the medication from draining out. Try not to blink and do||
0235|035|H|not rub your eye. Repeat these steps for your other eye if so||
0235|036|H|directed, and if your dose is for more than 1 drop.||
0235|037|H|   Do not rinse the dropper. Replace the dropper cap after each||
0235|038|H|use.||
0235|039|H|   If you are using another kind of eye medication (such as drops||
0235|040|H|or ointments), wait at least 5 minutes before applying other||
0235|041|H|medications. Use eye drops before eye ointments to allow the eye||
0235|042|H|drops to enter the eye.||
0235|043|H|   Wait several minutes for your vision to clear before driving||
0235|044|H|or operating machinery.||
0235|045|H|   Use this medication regularly in order to get the most benefit||
0235|046|H|from it. Continue to use this medication for the full time||
0235|047|H|prescribed, even if symptoms disappear after a few days. Stopping||
0235|048|H|the medication too early may result in a return of the infection.||
0235|049|H|   Tell your doctor if your condition lasts or gets worse.||
0235|050|B|||
0235|051|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
0235|052|S|eyes for a minute or two when applied. Temporary blurred vision,||
0235|053|S|eye discomfort, itching, redness, dryness, tearing, feeling as if||
0235|054|S|something is in your eye, or sensitivity to light may occur. If||
0235|055|S|any of these effects last or get worse, notify your doctor or||
0235|056|S|pharmacist promptly.||
0235|057|S|   Remember that your doctor has prescribed this medication||
0235|058|S|because the benefit to you is greater than the risk of side||
0235|059|S|effects. Many people using this medication do not have serious||
0235|060|S|side effects.||
0235|061|S|   Use of this medication for prolonged or repeated periods may||
0235|062|S|result in a new fungal eye infection. Do not use it for longer||
0235|063|S|than prescribed. Contact your doctor if you notice new or||
0235|064|S|worsening symptoms.||
0235|065|S|   Tell your doctor right away if you have any serious side||
0235|066|S|effects, including: eye pain, swelling of your eyelids or face.||
0235|067|S|   A very serious allergic reaction to this drug is rare.||
0235|068|S|However, get medical help right away if you notice any symptoms||
0235|069|S|of a serious allergic reaction, including: rash, itching/swelling||
0235|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0235|071|S|breathing.||
0235|072|S|   This is not a complete list of possible side effects. If you||
0235|073|S|notice other effects not listed above, contact your doctor or||
0235|074|S|pharmacist.||
0235|075|S|   In the US -||
0235|076|S|   Call your doctor for medical advice about side effects. You||
0235|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0235|078|S|www.fda.gov/medwatch.||
0235|079|S|   In Canada - Call your doctor for medical advice about side||
0235|080|S|effects. You may report side effects to Health Canada at||
0235|081|S|1-866-234-2345.||
0235|082|B|||
0235|083|P|PRECAUTIONS:  Before using ofloxacin, tell your doctor or||
0235|084|P|pharmacist if you are allergic to it; or to other quinolones||
0235|085|P|(such as ciprofloxacin, levofloxacin); or if you have any other||
0235|086|P|allergies. This product may contain inactive ingredients (such as||
0235|087|P|preservatives like benzalkonium chloride), which can cause||
0235|088|P|allergic reactions or other problems. Talk to your pharmacist for||
0235|089|P|more details.||
0235|090|P|   Before using this medication, tell your doctor or pharmacist||
0235|091|P|your medical history, especially of: other eye problems.||
0235|092|P|   After you apply this drug, your vision may become temporarily||
0235|093|P|blurred or unstable. Do not drive, use machinery, or do anything||
0235|094|P|that needs clear vision until you can do it safely.||
0235|095|P|   During pregnancy, this medication should be used only when||
0235|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
0235|097|P|   It is unknown if this medication passes into breast milk.||
0235|098|P|Consult your doctor before breastfeeding.||
0235|099|B|||
0235|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0235|101|I|medications work or increase your risk for serious side effects.||
0235|102|I|This document does not contain all possible drug interactions.||
0235|103|I|Keep a list of all the products you use (including||
0235|104|I|prescription/nonprescription drugs and herbal products) and share||
0235|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
0235|106|I|the dosage of any medicines without your doctor's approval.||
0235|107|B|||
0235|108|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0235|109|O|has overdosed and has serious symptoms such as passing out or||
0235|110|O|trouble breathing, call 911. Otherwise, call a poison control||
0235|111|O|center right away. US residents can call 1-800-222-1222. Canada||
0235|112|O|residents can call 1-844-764-7669.||
0235|113|B|||
0235|114|N|NOTES:  Do not share this medication with others.||
0235|115|N|   This medication has been prescribed for your current condition||
0235|116|N|only. Throw away the unused medication after treatment is||
0235|117|N|completed. Do not use it later for another infection unless your||
0235|118|N|doctor tells you to.||
0235|119|B|||
0235|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0235|121|D|If it is near the time of the next dose, skip the missed dose.||
0235|122|D|Use your next dose at the regular time. Do not double the dose to||
0235|123|D|catch up.||
0235|124|B|||
0235|125|R|STORAGE:  Store at room temperature. Discard the solution if it||
0235|126|R|changes color, becomes cloudy, or develops particles. Keep all||
0235|127|R|medications away from children and pets.||
0235|128|R|   Do not flush medications down the toilet or pour them into a||
0235|129|R|drain unless instructed to do so. Properly discard this product||
0235|130|R|when it is expired or no longer needed. Consult your pharmacist||
0235|131|R|or local waste disposal company.||
0235|132|B|||
0235|133|A|Information last revised October 2024.||
0235|134|A|Copyright(c) 2025 First Databank, Inc.||
0235|135|B|||
0236|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0236|002|Z|does NOT have all possible information about this product. This||
0236|003|Z|information does not assure that this product is safe, effective,||
0236|004|Z|or appropriate for you. This information is not individual||
0236|005|Z|medical advice and does not substitute for the advice of your||
0236|006|Z|health care professional. Always ask your health care||
0236|007|Z|professional for complete information about this product and your||
0236|008|Z|specific health needs.||
0236|009|B|||
0236|010|T|ALUMINUM CHLORIDE SOLUTION - TOPICAL||
0236|011|F|(a-LOO-mi-num KLOR-ide)||
0236|012|B|||
0236|013|C|COMMON BRAND NAME(S): Drysol, Xerac AC||
0236|014|B|||
0236|015|U|USES:  This medication is used to help control excessive||
0236|016|U|sweating.||
0236|017|B|||
0236|018|H|HOW TO USE:  Use this medication on the skin only. The affected||
0236|019|H|area should be dry before the medication is applied. If needed,||
0236|020|H|dry the affected area with a hair dryer on the warm setting for a||
0236|021|H|few minutes. Learn all preparation and usage instructions in the||
0236|022|H|product package. If any of the information is unclear, consult||
0236|023|H|your doctor or pharmacist.||
0236|024|H|   Do not get the medication in your eyes or apply it to broken,||
0236|025|H|irritated, or recently shaved skin. If you do get the medication||
0236|026|H|on those areas, flush with plenty of water.||
0236|027|H|   Apply a thin layer of this medication to the affected area as||
0236|028|H|directed by your doctor, usually once daily at bedtime for 2 to 3||
0236|029|H|days until the sweating is controlled, then once or twice a week||
0236|030|H|thereafter. After applying the medication, let it dry. If||
0236|031|H|applying on the hands or feet, wrap the area with plastic wrap||
0236|032|H|and cover with a mitten or sock. If applying on the underarms,||
0236|033|H|wear a shirt. If applying on the scalp, wear a plastic shower||
0236|034|H|cap. Leave this medication on for 6 to 8 hours. In the morning,||
0236|035|H|wash the area with soap (or shampoo if treating the scalp) and||
0236|036|H|water, and then towel dry. Do not use other antiperspirants or||
0236|037|H|deodorants while using this medication.||
0236|038|H|   Tell your doctor if your condition lasts or gets worse.||
0236|039|B|||
0236|040|S|SIDE EFFECTS:  Tingling, mild itching, or irritation may occur||
0236|041|S|when the medication is first applied. If any of these effects||
0236|042|S|last or get worse, tell your doctor or pharmacist promptly.||
0236|043|S|   Remember that this medication has been prescribed because your||
0236|044|S|doctor has judged that the benefit to you is greater than the||
0236|045|S|risk of side effects. Many people using this medication do not||
0236|046|S|have serious side effects.||
0236|047|S|   A very serious allergic reaction to this drug is rare.||
0236|048|S|However, get medical help right away if you notice any symptoms||
0236|049|S|of a serious allergic reaction, including: rash, itching/swelling||
0236|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0236|051|S|breathing.||
0236|052|S|   This is not a complete list of possible side effects. If you||
0236|053|S|notice other effects not listed above, contact your doctor or||
0236|054|S|pharmacist.||
0236|055|S|   In the US -||
0236|056|S|   Call your doctor for medical advice about side effects. You||
0236|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0236|058|S|www.fda.gov/medwatch.||
0236|059|S|   In Canada - Call your doctor for medical advice about side||
0236|060|S|effects. You may report side effects to Health Canada at||
0236|061|S|1-866-234-2345.||
0236|062|B|||
0236|063|P|PRECAUTIONS:  Before using aluminum chloride, tell your doctor or||
0236|064|P|pharmacist if you are allergic to it; or if you have any other||
0236|065|P|allergies. This product may contain inactive ingredients, which||
0236|066|P|can cause allergic reactions or other problems. Talk to your||
0236|067|P|pharmacist for more details.||
0236|068|P|   Before using this medication, tell your doctor or pharmacist||
0236|069|P|your medical history.||
0236|070|P|   This medication may stain clothing or certain fabrics or harm||
0236|071|P|metals. Use this medication cautiously to avoid contact with||
0236|072|P|clothes, bed linens, other fabrics, or metals. Let this||
0236|073|P|medication dry completely before putting clothing over the||
0236|074|P|treated area.||
0236|075|P|   During pregnancy, this medication should be used only when||
0236|076|P|clearly needed. Discuss the risks and benefits with your doctor.||
0236|077|P|   It is unknown if this medication passes into breast milk.||
0236|078|P|Consult your doctor before breastfeeding.||
0236|079|B|||
0236|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0236|081|I|medications work or increase your risk for serious side effects.||
0236|082|I|This document does not contain all possible drug interactions.||
0236|083|I|Keep a list of all the products you use (including||
0236|084|I|prescription/nonprescription drugs and herbal products) and share||
0236|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
0236|086|I|the dosage of any medicines without your doctor's approval.||
0236|087|I|   Some products that may interact with this drug include:||
0236|088|I|deodorants, other antiperspirants, disulfiram, metronidazole,||
0236|089|I|tinidazole.||
0236|090|B|||
0236|091|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0236|092|O|has overdosed and has serious symptoms such as passing out or||
0236|093|O|trouble breathing, call 911. Otherwise, call a poison control||
0236|094|O|center right away. US residents can call 1-800-222-1222. Canada||
0236|095|O|residents can call 1-844-764-7669.||
0236|096|B|||
0236|097|N|NOTES:  Do not share this medication with others.||
0236|098|B|||
0236|099|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0236|100|D|If it is near the time of the next dose, skip the missed dose.||
0236|101|D|Use your next dose at the regular time. Do not double the dose to||
0236|102|D|catch up.||
0236|103|B|||
0236|104|R|STORAGE:  Store at room temperature away from heat. Do not use||
0236|105|R|near an open flame. Keep all medications away from children and||
0236|106|R|pets.||
0236|107|R|   Do not flush medications down the toilet or pour them into a||
0236|108|R|drain unless instructed to do so. Properly discard this product||
0236|109|R|when it is expired or no longer needed. Consult your pharmacist||
0236|110|R|or local waste disposal company.||
0236|111|B|||
0236|112|A|Information last revised September 2024.||
0236|113|A|Copyright(c) 2025 First Databank, Inc.||
0236|114|B|||
0237|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0237|002|Z|does NOT have all possible information about this product. This||
0237|003|Z|information does not assure that this product is safe, effective,||
0237|004|Z|or appropriate for you. This information is not individual||
0237|005|Z|medical advice and does not substitute for the advice of your||
0237|006|Z|health care professional. Always ask your health care||
0237|007|Z|professional for complete information about this product and your||
0237|008|Z|specific health needs.||
0237|009|B|||
0237|010|T|PILOCARPINE - ORAL||
0237|011|F|(PYE-loe-KAR-peen)||
0237|012|B|||
0237|013|C|COMMON BRAND NAME(S): Salagen||
0237|014|B|||
0237|015|U|USES:  This medication is used to treat symptoms of dry mouth due||
0237|016|U|to a certain immune disease (Sjogren's syndrome) or from saliva||
0237|017|U|gland damage due to radiation treatments of the head/neck for||
0237|018|U|cancer. Pilocarpine belongs to a class of drugs known as||
0237|019|U|cholinergic agonists. It works by stimulating certain nerves to||
0237|020|U|increase the amount of saliva you produce, making it easier and||
0237|021|U|more comfortable to speak and swallow.||
0237|022|B|||
0237|023|H|HOW TO USE:  Take this medication by mouth with or without food||
0237|024|H|as directed by your doctor, usually 3 to 4 times daily. The||
0237|025|H|dosage is based on your medical condition and response to||
0237|026|H|treatment.||
0237|027|H|   To reduce your risk of side effects, your doctor may direct||
0237|028|H|you to start this medication at a low dose and gradually increase||
0237|029|H|your dose. Follow your doctor's instructions carefully.||
0237|030|H|   Take this medication regularly to get the most benefit from||
0237|031|H|it. To help you remember, take it at the same times each day.||
0237|032|H|   You may continue to drink water or use saliva substitutes as||
0237|033|H|needed for moisture in your mouth.||
0237|034|H|   You may start to feel some benefit in 1 to 2 weeks. However,||
0237|035|H|it may take up to 3 months to feel the full benefit. Tell your||
0237|036|H|doctor if your condition lasts or gets worse.||
0237|037|B|||
0237|038|S|SIDE EFFECTS:  Sweating, nausea, runny nose, chills, flushing,||
0237|039|S|frequent urge to urinate, dizziness, weakness, diarrhea, and||
0237|040|S|blurred vision may occur. If any of these effects last or get||
0237|041|S|worse, tell your doctor or pharmacist promptly.||
0237|042|S|   This medication may cause an increase in tears. This can be||
0237|043|S|helpful if you have dry eyes (such as with Sjogren's syndrome).||
0237|044|S|Tell your doctor if runny eyes become a problem.||
0237|045|S|   Remember that this medication has been prescribed because your||
0237|046|S|doctor has judged that the benefit to you is greater than the||
0237|047|S|risk of side effects. Many people using this medication do not||
0237|048|S|have serious side effects.||
0237|049|S|   Tell your doctor right away if you have any serious side||
0237|050|S|effects, including: slow/fast heartbeat, shakiness (tremor),||
0237|051|S|fainting, lung problems (such as increased||
0237|052|S|wheezing/cough/phlegm), mental/mood changes (such as confusion,||
0237|053|S|agitation), severe stomach/abdominal pain.||
0237|054|S|   A very serious allergic reaction to this drug is rare.||
0237|055|S|However, get medical help right away if you notice any symptoms||
0237|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0237|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0237|058|S|breathing.||
0237|059|S|   This is not a complete list of possible side effects. If you||
0237|060|S|notice other effects not listed above, contact your doctor or||
0237|061|S|pharmacist.||
0237|062|S|   In the US -||
0237|063|S|   Call your doctor for medical advice about side effects. You||
0237|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0237|065|S|www.fda.gov/medwatch.||
0237|066|S|   In Canada - Call your doctor for medical advice about side||
0237|067|S|effects. You may report side effects to Health Canada at||
0237|068|S|1-866-234-2345.||
0237|069|B|||
0237|070|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0237|071|P|pharmacist if you are allergic to it; or if you have any other||
0237|072|P|allergies. This product may contain inactive ingredients, which||
0237|073|P|can cause allergic reactions or other problems. Talk to your||
0237|074|P|pharmacist for more details.||
0237|075|P|   Before using this medication, tell your doctor or pharmacist||
0237|076|P|your medical history, especially of: breathing problems (such as||
0237|077|P|asthma, chronic bronchitis, chronic obstructive pulmonary||
0237|078|P|disease-COPD), certain eye conditions (such as night blindness,||
0237|079|P|acute iritis, narrow-angle glaucoma), heart disease (such as||
0237|080|P|chest pain, heart failure, heart attack, slow heartbeat), low or||
0237|081|P|high blood pressure, liver problems, gallbladder disease (such as||
0237|082|P|gallstones), kidney stones, mental/mood disorders (such as||
0237|083|P|depression, psychoses, thinking/understanding problems like||
0237|084|P|dementia, Alzheimer's), stomach problems (such as chronic||
0237|085|P|heartburn, ulcer).||
0237|086|P|   This drug may make you dizzy or cause vision problems,||
0237|087|P|especially at night. Alcohol or marijuana (cannabis) can make you||
0237|088|P|more dizzy. Do not drive, use machinery, or do anything that||
0237|089|P|needs alertness or clear vision, especially at night, until you||
0237|090|P|can do it safely. Limit alcoholic beverages. Talk to your doctor||
0237|091|P|if you are using marijuana (cannabis).||
0237|092|P|   If pilocarpine makes you sweat heavily, drink plenty of fluids||
0237|093|P|so that you do not become dehydrated. If you are unable to drink||
0237|094|P|enough fluids, talk with your doctor right away.||
0237|095|P|   Before having surgery, tell your doctor or dentist about all||
0237|096|P|the products you use (including prescription drugs,||
0237|097|P|nonprescription drugs, and herbal products).||
0237|098|P|   Older adults may be more sensitive to the side effects of this||
0237|099|P|drug, especially dizziness, diarrhea, and increased urge to||
0237|100|P|urinate.||
0237|101|P|   During pregnancy, this medication should be used only when||
0237|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0237|103|P|   It is unknown if this drug passes into breast milk. Consult||
0237|104|P|your doctor before breastfeeding.||
0237|105|B|||
0237|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0237|107|I|medications work or increase your risk for serious side effects.||
0237|108|I|This document does not contain all possible drug interactions.||
0237|109|I|Keep a list of all the products you use (including||
0237|110|I|prescription/nonprescription drugs and herbal products) and share||
0237|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0237|112|I|the dosage of any medicines without your doctor's approval.||
0237|113|B|||
0237|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0237|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0237|116|O|poison control center right away. US residents can call||
0237|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0237|118|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
0237|119|O|heavy sweating, trouble breathing, stomach cramps, vomiting, very||
0237|120|O|slow/fast heartbeat, severe confusion.||
0237|121|B|||
0237|122|N|NOTES:  Do not share this medication with others.||
0237|123|B|||
0237|124|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0237|125|D|remember. If it is near the time of the next dose, skip the||
0237|126|D|missed dose. Take your next dose at the regular time. Do not||
0237|127|D|double the dose to catch up.||
0237|128|B|||
0237|129|R|STORAGE:  Store at room temperature away from light and moisture.||
0237|130|R|Do not store in the bathroom. Keep all medications away from||
0237|131|R|children and pets.||
0237|132|R|   Do not flush medications down the toilet or pour them into a||
0237|133|R|drain unless instructed to do so. Properly discard this product||
0237|134|R|when it is expired or no longer needed. Consult your pharmacist||
0237|135|R|or local waste disposal company.||
0237|136|B|||
0237|137|A|Information last revised May 2024.||
0237|138|A|Copyright(c) 2025 First Databank, Inc.||
0237|139|B|||
0239|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0239|002|Z|does NOT have all possible information about this product. This||
0239|003|Z|information does not assure that this product is safe, effective,||
0239|004|Z|or appropriate for you. This information is not individual||
0239|005|Z|medical advice and does not substitute for the advice of your||
0239|006|Z|health care professional. Always ask your health care||
0239|007|Z|professional for complete information about this product and your||
0239|008|Z|specific health needs.||
0239|009|B|||
0239|010|T|OPIUM TINCTURE - ORAL||
0239|011|F|(OH-pee-um)||
0239|012|B|||
0239|013|U|USES:  This medication is used to treat diarrhea. It helps to||
0239|014|U|decrease how often you have bowel movements. It works by slowing||
0239|015|U|the movement of the intestines. Opium belongs to a class of drugs||
0239|016|U|known as opioid pain relievers, but this medication acts mainly||
0239|017|U|to slow the gut.||
0239|018|B|||
0239|019|V|OTHER USES:  This section contains uses of this drug that are not||
0239|020|V|listed in the approved professional labeling for the drug but||
0239|021|V|that may be prescribed by your health care professional. Use this||
0239|022|V|drug for a condition that is listed in this section only if it||
0239|023|V|has been so prescribed by your health care professional.||
0239|024|V|   A very weak solution of this drug may also be used for severe||
0239|025|V|withdrawal symptoms in infants born to mothers who were addicted||
0239|026|V|to opioids during pregnancy.||
0239|027|B|||
0239|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
0239|029|H|doctor, usually 4 times daily. It may be taken with food or meals||
0239|030|H|if stomach upset occurs.||
0239|031|H|   Carefully measure each dose using the dropper provided. If||
0239|032|H|your medication comes in an oral dosing syringe, use the syringe||
0239|033|H|to measure the dose. Do not use a household spoon because you may||
0239|034|H|not get the correct dose. Do not inject the medication. The dose||
0239|035|H|may be mixed with a small amount of water just before taking.||
0239|036|H|   The dosage is based on your medical condition and response to||
0239|037|H|treatment.||
0239|038|H|   If you suddenly stop using this medication, you may have||
0239|039|H|withdrawal symptoms (such as sweating, nausea, vomiting,||
0239|040|H|restlessness). To help prevent withdrawal, your doctor may lower||
0239|041|H|your dose slowly. Withdrawal is more likely if you have used||
0239|042|H|opium for a long time or in high doses. Tell your doctor or||
0239|043|H|pharmacist right away if you have withdrawal.||
0239|044|H|   Though it helps many people, this medication may sometimes||
0239|045|H|cause addiction. This risk may be higher if you have a||
0239|046|H|mental/mood disorder or a substance use disorder (such as overuse||
0239|047|H|of or addiction to drugs/alcohol). Do not increase your dose,||
0239|048|H|take it more often, or use it for a longer time than prescribed.||
0239|049|H|Properly stop the medication when so directed.||
0239|050|H|   When used for a long time, this medication may not work as||
0239|051|H|well and may require different dosing. Talk with your doctor if||
0239|052|H|this medication stops working well.||
0239|053|H|   Diarrhea can sometimes cause dehydration. It is important that||
0239|054|H|you drink the proper amount of fluids and electrolytes to prevent||
0239|055|H|this effect. Tell your doctor right away if you develop signs of||
0239|056|H|dehydration (such as unusual decreased urination, unusual dry||
0239|057|H|mouth/thirst, fast heartbeat, or dizziness/lightheadedness). You||
0239|058|H|may also need to change to a bland diet during this time to||
0239|059|H|reduce irritation to your stomach/intestines. Consult your doctor||
0239|060|H|or pharmacist for more information.||
0239|061|H|   Tell your doctor if your condition lasts or gets worse after 2||
0239|062|H|to 3 days of treatment.||
0239|063|B|||
0239|064|S|SIDE EFFECTS:  Nausea, vomiting, lightheadedness, dizziness,||
0239|065|S|drowsiness, or constipation may occur. If any of these effects||
0239|066|S|last or get worse, tell your doctor or pharmacist promptly.||
0239|067|S|   To reduce the risk of dizziness and lightheadedness, get up||
0239|068|S|slowly when rising from a sitting or lying position.||
0239|069|S|   Remember that this medication has been prescribed because your||
0239|070|S|doctor has judged that the benefit to you is greater than the||
0239|071|S|risk of side effects. Many people using this medication do not||
0239|072|S|have serious side effects.||
0239|073|S|   Tell your doctor right away if you have any serious side||
0239|074|S|effects, including: mental/mood changes (such as agitation,||
0239|075|S|confusion, hallucinations), trouble swallowing, severe||
0239|076|S|stomach/abdominal pain, difficulty urinating.||
0239|077|S|   Get medical help right away if you have any very serious side||
0239|078|S|effects, including: fainting, seizure, slow/shallow breathing,||
0239|079|S|severe drowsiness/difficulty waking up.||
0239|080|S|   A very serious allergic reaction to this drug is rare.||
0239|081|S|However, get medical help right away if you notice any symptoms||
0239|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0239|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0239|084|S|breathing.||
0239|085|S|   This is not a complete list of possible side effects. If you||
0239|086|S|notice other effects not listed above, contact your doctor or||
0239|087|S|pharmacist.||
0239|088|S|   In the US -||
0239|089|S|   Call your doctor for medical advice about side effects. You||
0239|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0239|091|S|www.fda.gov/medwatch.||
0239|092|S|   In Canada - Call your doctor for medical advice about side||
0239|093|S|effects. You may report side effects to Health Canada at||
0239|094|S|1-866-234-2345.||
0239|095|B|||
0239|096|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0239|097|P|pharmacist if you are allergic to it; or to other opioids (such||
0239|098|P|as codeine, morphine); or to papaverine; or if you have any other||
0239|099|P|allergies. This product may contain inactive ingredients, which||
0239|100|P|can cause allergic reactions or other problems. Talk to your||
0239|101|P|pharmacist for more details.||
0239|102|P|   Before using this medication, tell your doctor or pharmacist||
0239|103|P|your medical history, especially of: brain disorders (such as||
0239|104|P|head injury, tumor, seizures), breathing problems (such as||
0239|105|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0239|106|P|kidney disease, liver disease, mental/mood disorders (such as||
0239|107|P|confusion, depression), personal or family history of a substance||
0239|108|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
0239|109|P|stomach/intestinal problems (such as blockage, constipation,||
0239|110|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
0239|111|P|(such as due to enlarged prostate), disease of the pancreas||
0239|112|P|(pancreatitis), gallbladder disease.||
0239|113|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0239|114|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0239|115|P|machinery, or do anything that needs alertness until you can do||
0239|116|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0239|117|P|are using marijuana (cannabis).||
0239|118|P|   This product also contains alcohol. Caution is advised if you||
0239|119|P|have diabetes, liver disease, or any other condition that||
0239|120|P|requires you to limit/avoid alcohol in your diet. Ask your doctor||
0239|121|P|or pharmacist about using this product safely.||
0239|122|P|   Before having surgery, tell your doctor or dentist about all||
0239|123|P|the products you use (including prescription drugs,||
0239|124|P|nonprescription drugs, and herbal products).||
0239|125|P|   Children may be more sensitive to the side effects of this||
0239|126|P|drug, especially slow/shallow breathing.||
0239|127|P|   Older adults may be more sensitive to side effects of this||
0239|128|P|drug, especially slow/shallow breathing and drowsiness.||
0239|129|P|   Before using this medication, women of childbearing age should||
0239|130|P|talk with their doctor(s) about the risks and benefits. Tell your||
0239|131|P|doctor if you are pregnant or if you plan to become pregnant.||
0239|132|P|During pregnancy, this medication should be used only when||
0239|133|P|clearly needed. It may slightly increase the risk of birth||
0239|134|P|defects if used during the first two months of pregnancy. Also,||
0239|135|P|using it for a long time or in high doses near the expected||
0239|136|P|delivery date may harm the unborn baby. To lessen the risk, take||
0239|137|P|the smallest effective dose for the shortest possible time. Tell||
0239|138|P|the doctor right away if you notice any symptoms in your newborn||
0239|139|P|baby such as slow/shallow breathing, irritability, crying that is||
0239|140|P|unusual or doesn't stop, vomiting, or diarrhea.||
0239|141|P|   This drug passes into breast milk and may have undesirable||
0239|142|P|effects on a nursing infant. Tell the doctor right away if your||
0239|143|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0239|144|P|breathing. Consult your doctor before breastfeeding.||
0239|145|B|||
0239|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0239|147|I|medications work or increase your risk for serious side effects.||
0239|148|I|This document does not contain all possible drug interactions.||
0239|149|I|Keep a list of all the products you use (including||
0239|150|I|prescription/nonprescription drugs and herbal products) and share||
0239|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
0239|152|I|the dosage of any medicines without your doctor's approval.||
0239|153|I|   Some products that may interact with this drug are: certain||
0239|154|I|pain medications (mixed opioid agonist/antagonists such as||
0239|155|I|pentazocine, nalbuphine, butorphanol), naltrexone.||
0239|156|I|   The risk of serious side effects (such as slow/shallow||
0239|157|I|breathing, severe drowsiness/dizziness) may be increased if this||
0239|158|I|medication is taken with other products that may also cause||
0239|159|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0239|160|I|if you are taking other products such as other opioid pain or||
0239|161|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0239|162|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0239|163|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0239|164|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0239|165|I|cetirizine, diphenhydramine).||
0239|166|I|   Check the labels on all your medicines (such as allergy or||
0239|167|I|cough-and-cold products) because they may contain ingredients||
0239|168|I|that cause drowsiness. Ask your pharmacist about using those||
0239|169|I|products safely.||
0239|170|B|||
0239|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0239|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0239|173|O|poison control center right away. US residents can call||
0239|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0239|175|O|Symptoms of overdose may include: slowed breathing, slow||
0239|176|O|heartbeat, severe dizziness/drowsiness, fainting, muscle||
0239|177|O|weakness.||
0239|178|B|||
0239|179|N|NOTES:  Do not share this medication with others. Sharing it is||
0239|180|N|against the law.||
0239|181|B|||
0239|182|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0239|183|D|remember. If it is near the time of the next dose, skip the||
0239|184|D|missed dose. Take your next dose at the regular time. Do not||
0239|185|D|double the dose to catch up.||
0239|186|B|||
0239|187|R|STORAGE:  Store at room temperature away from light and moisture.||
0239|188|R|Do not store in the bathroom. Keep all medications away from||
0239|189|R|children and pets.||
0239|190|R|   Do not flush medications down the toilet or pour them into a||
0239|191|R|drain unless instructed to do so. Properly discard this product||
0239|192|R|when it is expired or no longer needed. Consult your pharmacist||
0239|193|R|or local waste disposal company.||
0239|194|B|||
0239|195|A|Information last revised August 2025.||
0239|196|A|Copyright(c) 2025 First Databank, Inc.||
0239|197|B|||
0241|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0241|002|Z|does NOT have all possible information about this product. This||
0241|003|Z|information does not assure that this product is safe, effective,||
0241|004|Z|or appropriate for you. This information is not individual||
0241|005|Z|medical advice and does not substitute for the advice of your||
0241|006|Z|health care professional. Always ask your health care||
0241|007|Z|professional for complete information about this product and your||
0241|008|Z|specific health needs.||
0241|009|B|||
0241|010|T|TIAPROFENIC ACID - ORAL||
0241|011|F|(TYE-a-pro-FEN-ick AS-id)||
0241|012|B|||
0241|013|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0241|014|W|tiaprofenic acid) may rarely increase the risk of a heart attack||
0241|015|W|or stroke. This effect can happen at any time while taking this||
0241|016|W|drug but is more likely if you take it for a long time. The risk||
0241|017|W|may be greater in older adults or if you have heart disease or||
0241|018|W|increased risk for heart disease (for example, due to smoking,||
0241|019|W|family history of heart disease, or conditions such as high blood||
0241|020|W|pressure or diabetes). Do not take this drug right before or||
0241|021|W|after heart bypass surgery (CABG).||
0241|022|W|   Also, this drug may rarely cause serious (rarely fatal)||
0241|023|W|bleeding from the stomach or intestines. This effect can occur||
0241|024|W|without warning symptoms at any time while taking this drug.||
0241|025|W|Older adults may be at higher risk for this effect.||
0241|026|W|   Stop taking tiaprofenic acid and get medical help right away||
0241|027|W|if you notice any of these rare but serious side effects:||
0241|028|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0241|029|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0241|030|W|shortness of breath, unusual sweating, confusion, weakness on one||
0241|031|W|side of the body, trouble speaking, sudden vision changes.||
0241|032|W|   Talk to your doctor or pharmacist about the benefits and risks||
0241|033|W|of taking this drug.||
0241|034|B|||
0241|035|U|USES:  See also Warning section.||
0241|036|U|   Tiaprofenic acid is used to reduce pain, swelling, and joint||
0241|037|U|stiffness from arthritis. Reducing symptoms of arthritis may||
0241|038|U|improve your ability to move/exercise, work, and perform tasks||
0241|039|U|normally.||
0241|040|U|   Tiaprofenic acid is known as a nonsteroidal anti-inflammatory||
0241|041|U|drug (NSAID). It works by blocking your body's production of||
0241|042|U|certain natural substances that cause inflammation.||
0241|043|U|   Ask your doctor about non-drug treatments and/or using other||
0241|044|U|medications to treat your chronic pain.||
0241|045|B|||
0241|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0241|047|H|from your pharmacist before you start taking tiaprofenic acid and||
0241|048|H|each time you get a refill. If you have any questions, ask your||
0241|049|H|doctor or pharmacist.||
0241|050|H|   Take this medication by mouth as directed by your doctor,||
0241|051|H|usually 2 to 3 times daily. Take this medication with a full||
0241|052|H|glass of water (8 ounces or 240 milliliters) unless your doctor||
0241|053|H|directs you otherwise. Do not lie down for at least 10 minutes||
0241|054|H|after taking this medication. If stomach upset occurs while||
0241|055|H|taking this medication, take it with food, milk, or an antacid.||
0241|056|H|   The dosage is based on your medical condition and response to||
0241|057|H|treatment. To reduce your risk of stomach bleeding and other side||
0241|058|H|effects, take this medication at the lowest effective dose for||
0241|059|H|the shortest possible time. Do not increase your dose or use this||
0241|060|H|drug more often or for longer than prescribed. Discuss the risks||
0241|061|H|and benefits with your doctor or pharmacist.||
0241|062|H|   Use this medication regularly to get the most benefit from it.||
0241|063|H|To help you remember, take it at the same times each day. It may||
0241|064|H|take up to 2 weeks of taking this drug regularly until you get||
0241|065|H|the full benefit.||
0241|066|H|   Tell your doctor if your condition gets worse.||
0241|067|B|||
0241|068|S|SIDE EFFECTS:  See also Warning section.||
0241|069|S|   Upset stomach, nausea, drowsiness, dizziness, or blurred||
0241|070|S|vision may occur. If any of these effects last or get worse, tell||
0241|071|S|your doctor or pharmacist promptly.||
0241|072|S|   Remember that this medication has been prescribed because your||
0241|073|S|doctor has judged that the benefit to you is greater than the||
0241|074|S|risk of side effects. Many people using this medication do not||
0241|075|S|have serious side effects.||
0241|076|S|   This medication may raise your blood pressure. Check your||
0241|077|S|blood pressure regularly and tell your doctor if the results are||
0241|078|S|high.||
0241|079|S|   Tell your doctor right away if you have any serious side||
0241|080|S|effects, including: hearing changes (such as ringing in the||
0241|081|S|ears), mental/mood changes, easy bleeding/bruising,||
0241|082|S|difficult/painful swallowing, signs of kidney problems (such as||
0241|083|S|change in the amount of urine, pink/bloody urine), symptoms of||
0241|084|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
0241|085|S|unusual/sudden weight gain).||
0241|086|S|   Tiaprofenic acid may rarely cause serious (possibly fatal)||
0241|087|S|liver disease. Get medical help right away if you have any||
0241|088|S|symptoms of liver damage, including: nausea/vomiting that doesn't||
0241|089|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
0241|090|S|eyes/skin, dark urine.||
0241|091|S|   A very serious allergic reaction to this drug is rare.||
0241|092|S|However, get medical help right away if you notice any symptoms||
0241|093|S|of a serious allergic reaction, including: fever, swollen lymph||
0241|094|S|nodes, rash, itching/swelling (especially of the||
0241|095|S|face/tongue/throat), severe dizziness, trouble breathing.||
0241|096|S|   This is not a complete list of possible side effects. If you||
0241|097|S|notice other effects not listed above, contact your doctor or||
0241|098|S|pharmacist.||
0241|099|S|   In the US -||
0241|100|S|   Call your doctor for medical advice about side effects. You||
0241|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0241|102|S|www.fda.gov/medwatch.||
0241|103|S|   In Canada - Call your doctor for medical advice about side||
0241|104|S|effects. You may report side effects to Health Canada at||
0241|105|S|1-866-234-2345.||
0241|106|B|||
0241|107|P|PRECAUTIONS:  See also Warning section.||
0241|108|P|   Before taking tiaprofenic acid, tell your doctor or pharmacist||
0241|109|P|if you are allergic to it; or to aspirin or other NSAIDs (such as||
0241|110|P|ibuprofen, naproxen, celecoxib); or if you have any other||
0241|111|P|allergies. This product may contain inactive ingredients, which||
0241|112|P|can cause allergic reactions or other problems. Talk to your||
0241|113|P|pharmacist for more details.||
0241|114|P|   Before using this medication, tell your doctor or pharmacist||
0241|115|P|your medical history, especially of: asthma (including a history||
0241|116|P|of worsening breathing after taking aspirin or other NSAIDs),||
0241|117|P|bleeding/clotting problems, blood disorders (such as anemia),||
0241|118|P|growths in the nose (nasal polyps), heart disease (such as||
0241|119|P|previous heart attack), high blood pressure, liver disease,||
0241|120|P|stroke, swelling (edema, fluid retention),||
0241|121|P|stomach/intestinal/esophagus problems (such as bleeding,||
0241|122|P|heartburn, ulcers).||
0241|123|P|   Kidney problems can sometimes occur with the use of NSAID||
0241|124|P|medications, including tiaprofenic acid. Problems are more likely||
0241|125|P|to occur if you are dehydrated, have heart failure or kidney||
0241|126|P|disease, are an older adult, or if you take certain medications||
0241|127|P|(see also Drug Interactions section). Drink plenty of fluids as||
0241|128|P|directed by your doctor to prevent dehydration and tell your||
0241|129|P|doctor right away if you have pink/bloody urine or any unusual||
0241|130|P|change in the amount of urine.||
0241|131|P|   This drug may make you dizzy or drowsy or cause blurred||
0241|132|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
0241|133|P|Do not drive, use machinery, or do anything that needs alertness||
0241|134|P|or clear vision until you can do it safely. Limit alcoholic||
0241|135|P|beverages. Talk to your doctor if you are using marijuana||
0241|136|P|(cannabis).||
0241|137|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0241|138|P|and tobacco, especially when combined with this medicine, may||
0241|139|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0241|140|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
0241|141|P|may safely drink.||
0241|142|P|   This medication may make you more sensitive to the sun. Limit||
0241|143|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0241|144|P|sunscreen and wear protective clothing when outdoors. Tell your||
0241|145|P|doctor right away if you get sunburned or have skin||
0241|146|P|blisters/redness.||
0241|147|P|   Before having surgery, tell your doctor or dentist about all||
0241|148|P|the products you use (including prescription drugs,||
0241|149|P|nonprescription drugs, and herbal products).||
0241|150|P|   Older adults may be at greater risk for stomach/intestinal||
0241|151|P|bleeding, kidney problems, heart attack, and stroke while using||
0241|152|P|this drug.||
0241|153|P|   Before using this medication, women of childbearing age should||
0241|154|P|talk with their doctor(s) about the benefits and risks. Tell your||
0241|155|P|doctor if you are pregnant or if you plan to become pregnant.||
0241|156|P|This medication may harm an unborn baby and cause problems with||
0241|157|P|normal labor/delivery. It is not recommended for use in pregnancy||
0241|158|P|from 20 weeks until delivery. If your doctor decides that you||
0241|159|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0241|160|P|you should use the lowest effective dose for the shortest||
0241|161|P|possible time. You should not use this medication after 30 weeks||
0241|162|P|of pregnancy.||
0241|163|P|   This drug passes into breast milk. Consult your doctor before||
0241|164|P|breastfeeding.||
0241|165|B|||
0241|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0241|167|I|medications work or increase your risk for serious side effects.||
0241|168|I|This document does not contain all possible drug interactions.||
0241|169|I|Keep a list of all the products you use (including||
0241|170|I|prescription/nonprescription drugs and herbal products) and share||
0241|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
0241|172|I|the dosage of any medicines without your doctor's approval.||
0241|173|I|   Some products that may interact with this drug are: aliskiren,||
0241|174|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
0241|175|I|receptor blockers (such as losartan, valsartan), cidofovir,||
0241|176|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
0241|177|I|methotrexate, "water pills" (diuretics such as furosemide).||
0241|178|I|   This medication may increase the risk of bleeding when taken||
0241|179|I|with other drugs that also may cause bleeding. Examples include||
0241|180|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0241|181|I|dabigatran/enoxaparin/warfarin, among others.||
0241|182|I|   Check all prescription and nonprescription medicine labels||
0241|183|I|carefully since many medications contain pain relievers/fever||
0241|184|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
0241|185|I|naproxen). These drugs are similar to tiaprofenic acid and may||
0241|186|I|increase your risk of side effects if taken together. However, if||
0241|187|I|your doctor has told you to take low-dose aspirin to prevent||
0241|188|I|heart attack or stroke (usually 81-162 milligrams a day), you||
0241|189|I|should keep taking the aspirin unless your doctor tells you not||
0241|190|I|to. Ask your doctor or pharmacist for more details.||
0241|191|B|||
0241|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0241|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0241|194|O|poison control center right away. US residents can call||
0241|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0241|196|O|Symptoms of overdose may include: severe stomach pain,||
0241|197|O|slow/shallow breathing.||
0241|198|B|||
0241|199|N|NOTES:  Do not share this medication with others.||
0241|200|N|   Lab and/or medical tests (such as complete blood count, liver||
0241|201|N|and kidney function, blood pressure) may be done while you are||
0241|202|N|using this medication. Keep all medical and lab appointments.||
0241|203|N|Consult your doctor for more details.||
0241|204|N|   Lifestyle changes (such as weight loss if needed,||
0241|205|N|strengthening/conditioning exercises) may help improve your||
0241|206|N|flexibility and joint function. Consult your doctor for specific||
0241|207|N|instructions.||
0241|208|B|||
0241|209|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0241|210|D|remember. If it is near the time of the next dose, skip the||
0241|211|D|missed dose. Take your next dose at the regular time. Do not||
0241|212|D|double the dose to catch up.||
0241|213|B|||
0241|214|R|STORAGE:  Store at room temperature away from light and moisture.||
0241|215|R|Do not store in the bathroom. Keep all medications away from||
0241|216|R|children and pets.||
0241|217|R|   Do not flush medications down the toilet or pour them into a||
0241|218|R|drain unless instructed to do so. Properly discard this product||
0241|219|R|when it is expired or no longer needed. Consult your pharmacist||
0241|220|R|or local waste disposal company.||
0241|221|B|||
0241|222|A|Information last revised November 2025.||
0241|223|A|Copyright(c) 2025 First Databank, Inc.||
0241|224|B|||
0242|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0242|002|Z|does NOT have all possible information about this product. This||
0242|003|Z|information does not assure that this product is safe, effective,||
0242|004|Z|or appropriate for you. This information is not individual||
0242|005|Z|medical advice and does not substitute for the advice of your||
0242|006|Z|health care professional. Always ask your health care||
0242|007|Z|professional for complete information about this product and your||
0242|008|Z|specific health needs.||
0242|009|B|||
0242|010|T|MECAMYLAMINE - ORAL||
0242|011|F|(MEK-a-MIL-a-meen)||
0242|012|B|||
0242|013|C|COMMON BRAND NAME(S): Vecamyl||
0242|014|B|||
0242|015|U|USES:  Mecamylamine is used to treat moderately severe to severe||
0242|016|U|high blood pressure. It can also be used in sudden high blood||
0242|017|U|pressure emergencies (malignant hypertension). Lowering high||
0242|018|U|blood pressure helps prevent strokes, heart attacks, and kidney||
0242|019|U|problems. Mecamylamine belongs to a class of drugs known as||
0242|020|U|ganglion blockers. It works by relaxing blood vessels so blood||
0242|021|U|can flow more easily.||
0242|022|B|||
0242|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
0242|024|H|doctor, usually 2 to 3 times daily. You may take this medication||
0242|025|H|with or without food, but it is important to choose one way and||
0242|026|H|take this medication the same way with every dose.||
0242|027|H|   The dosage is based on your medical condition and response to||
0242|028|H|treatment. To reduce your risk of side effects, your doctor may||
0242|029|H|direct you to start this medication at a low dose and gradually||
0242|030|H|increase your dose. Follow your doctor's instructions carefully.||
0242|031|H|   Take this medication regularly to get the most benefit from||
0242|032|H|it. To help you remember, take it at the same times each day.||
0242|033|H|Keep taking this medication even if you feel well. Most people||
0242|034|H|with high blood pressure do not feel sick.||
0242|035|H|   Do not stop taking this medication without consulting your||
0242|036|H|doctor. A rapid rise in blood pressure may occur when this drug||
0242|037|H|is suddenly stopped. This rapid rise in blood pressure may lead||
0242|038|H|to stroke or heart failure that can be severe (possibly fatal).||
0242|039|H|To prevent your blood pressure from getting too high if you are||
0242|040|H|stopping treatment with this drug, your doctor may reduce your||
0242|041|H|dose gradually and start you on another medication. Consult your||
0242|042|H|doctor or pharmacist for more details. Report any new or||
0242|043|H|worsening symptoms right away.||
0242|044|H|   It is important that you do not run out of mecamylamine or||
0242|045|H|miss any doses. Tell your doctor or pharmacist right away if you||
0242|046|H|are unable to take the medication (for example, due to vomiting).||
0242|047|H|   When this medication is used for a long time, it may not work||
0242|048|H|as well. Talk with your doctor if this medication stops working||
0242|049|H|well.||
0242|050|H|   Tell your doctor if your condition does not get better or if||
0242|051|H|it gets worse (your blood pressure readings remain high or||
0242|052|H|increase).||
0242|053|B|||
0242|054|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, tiredness,||
0242|055|S|blurred vision, decreased sexual ability/interest, nausea,||
0242|056|S|constipation, and dry mouth may occur as your body adjusts to the||
0242|057|S|medication. If any of these effects last or get worse, tell your||
0242|058|S|doctor or pharmacist promptly.||
0242|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
0242|060|S|slowly when rising from a sitting or lying position.||
0242|061|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0242|062|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0242|063|S|substitute.||
0242|064|S|   Remember that this medication has been prescribed because your||
0242|065|S|doctor has judged that the benefit to you is greater than the||
0242|066|S|risk of side effects. Many people using this medication do not||
0242|067|S|have serious side effects.||
0242|068|S|   Tell your doctor right away if you have any serious side||
0242|069|S|effects, including: fainting, difficulty urinating, shaking||
0242|070|S|(tremor), uncontrolled movements of the face/hands/arms/legs,||
0242|071|S|numb/tingling skin, stomach/abdominal pain, bloating.||
0242|072|S|   Get medical help right away if you have any very serious side||
0242|073|S|effects, including: mental/mood changes (such as anxiety,||
0242|074|S|confusion, depression), seizures.||
0242|075|S|   A very serious allergic reaction to this drug is rare.||
0242|076|S|However, get medical help right away if you notice any symptoms||
0242|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0242|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0242|079|S|breathing.||
0242|080|S|   This is not a complete list of possible side effects. If you||
0242|081|S|notice other effects not listed above, contact your doctor or||
0242|082|S|pharmacist.||
0242|083|S|   In the US -||
0242|084|S|   Call your doctor for medical advice about side effects. You||
0242|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0242|086|S|www.fda.gov/medwatch.||
0242|087|S|   In Canada - Call your doctor for medical advice about side||
0242|088|S|effects. You may report side effects to Health Canada at||
0242|089|S|1-866-234-2345.||
0242|090|B|||
0242|091|P|PRECAUTIONS:  Before taking mecamylamine, tell your doctor or||
0242|092|P|pharmacist if you are allergic to it; or if you have any other||
0242|093|P|allergies. This product may contain inactive ingredients, which||
0242|094|P|can cause allergic reactions or other problems. Talk to your||
0242|095|P|pharmacist for more details.||
0242|096|P|   Before using this medication, tell your doctor or pharmacist||
0242|097|P|your medical history, especially of: glaucoma, narrowing of the||
0242|098|P|opening from stomach into intestines (organic pyloric stenosis),||
0242|099|P|heart problems (such as chest pain, heart attack), blood flow||
0242|100|P|problems especially to the brain (such as stroke), kidney||
0242|101|P|disease, bladder/urination problems (such as bladder neck||
0242|102|P|obstruction, urethral stricture), enlarged prostate (prostatic||
0242|103|P|hypertrophy), salt-restricted diet.||
0242|104|P|   Before having surgery, tell your doctor or dentist about all||
0242|105|P|the products you use (including prescription drugs,||
0242|106|P|nonprescription drugs, and herbal products).||
0242|107|P|   This drug may make you dizzy or drowsy or blur your vision.||
0242|108|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0242|109|P|drowsy. Do not drive, use machinery, or do anything that needs||
0242|110|P|alertness or clear vision until you can do it safely. Limit||
0242|111|P|alcoholic beverages. Talk to your doctor if you are using||
0242|112|P|marijuana (cannabis).||
0242|113|P|   Too much sweating, diarrhea, or vomiting may cause you to feel||
0242|114|P|lightheaded. Report prolonged diarrhea or vomiting to your||
0242|115|P|doctor.||
0242|116|P|   During pregnancy, this medication should be used only when||
0242|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
0242|118|P|   It is unknown if this medication passes into breast milk.||
0242|119|P|Consult your doctor before breastfeeding.||
0242|120|B|||
0242|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0242|122|I|medications work or increase your risk for serious side effects.||
0242|123|I|This document does not contain all possible drug interactions.||
0242|124|I|Keep a list of all the products you use (including||
0242|125|I|prescription/nonprescription drugs and herbal products) and share||
0242|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
0242|127|I|the dosage of any medicines without your doctor's approval.||
0242|128|I|   A product that may interact with this drug is: ambenonium.||
0242|129|I|   Other medications can affect the removal of mecamylamine from||
0242|130|I|your body, which may affect how mecamylamine works. Examples||
0242|131|I|include urinary alkalinizers (sodium/potassium citrate), sodium||
0242|132|I|bicarbonate, among others.||
0242|133|I|   Tell your doctor or pharmacist if you are taking other||
0242|134|I|products that cause drowsiness, including alcohol, marijuana||
0242|135|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0242|136|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0242|137|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0242|138|I|codeine).||
0242|139|I|   Check the labels on all your medicines (such as allergy or||
0242|140|I|cough-and-cold products) because they may contain ingredients||
0242|141|I|that cause drowsiness or increase your blood pressure. Ask your||
0242|142|I|pharmacist about using those products safely.||
0242|143|B|||
0242|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0242|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0242|146|O|poison control center right away. US residents can call||
0242|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0242|148|O|Symptoms of overdose may include: severe weakness, severe/sudden||
0242|149|O|nausea and vomiting, anxiety, pounding heartbeat.||
0242|150|B|||
0242|151|N|NOTES:  Do not share this medication with others.||
0242|152|N|   Lifestyle changes that may help this medication work better||
0242|153|N|include exercising, stopping smoking, and eating a||
0242|154|N|low-cholesterol/low-fat diet. Consult your doctor for more||
0242|155|N|details.||
0242|156|N|   Lab and/or medical tests (such as blood pressure readings,||
0242|157|N|kidney function) should be done while you are taking this||
0242|158|N|medication. Keep all medical and lab appointments. Consult your||
0242|159|N|doctor for more details.||
0242|160|N|   Have your blood pressure checked regularly while taking this||
0242|161|N|medication. Learn how to monitor your own blood pressure at home,||
0242|162|N|and share the results with your doctor.||
0242|163|B|||
0242|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0242|165|D|remember. If it is near the time of the next dose, skip the||
0242|166|D|missed dose. Take your next dose at the regular time. Do not||
0242|167|D|double the dose to catch up.||
0242|168|B|||
0242|169|R|STORAGE:  Store at room temperature away from light and moisture.||
0242|170|R|Do not store in the bathroom. Keep all medications away from||
0242|171|R|children and pets.||
0242|172|R|   Do not flush medications down the toilet or pour them into a||
0242|173|R|drain unless instructed to do so. Properly discard this product||
0242|174|R|when it is expired or no longer needed. Consult your pharmacist||
0242|175|R|or local waste disposal company.||
0242|176|B|||
0242|177|A|Information last revised May 2024.||
0242|178|A|Copyright(c) 2025 First Databank, Inc.||
0242|179|B|||
0245|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0245|002|Z|does NOT have all possible information about this product. This||
0245|003|Z|information does not assure that this product is safe, effective,||
0245|004|Z|or appropriate for you. This information is not individual||
0245|005|Z|medical advice and does not substitute for the advice of your||
0245|006|Z|health care professional. Always ask your health care||
0245|007|Z|professional for complete information about this product and your||
0245|008|Z|specific health needs.||
0245|009|B|||
0245|010|T|FLUTICASONE SPRAY - NASAL||
0245|011|F|(floo-TIK-a-sone)||
0245|012|B|||
0245|013|C|COMMON BRAND NAME(S): Flonase||
0245|014|B|||
0245|015|U|USES:  Fluticasone is used to relieve seasonal and year-round||
0245|016|U|allergic and non-allergic nasal symptoms, such as stuffy/runny||
0245|017|U|nose, itching, and sneezing. It can also help relieve allergy eye||
0245|018|U|symptoms such as itchy, watery eyes. This medication belongs to a||
0245|019|U|class of drugs known as corticosteroids. It works in your nose to||
0245|020|U|block the effects of substances that cause allergies (such as||
0245|021|U|pollen, pet dander, dust mites, mold) and to reduce swelling.||
0245|022|B|||
0245|023|H|HOW TO USE:  If you are using the over-the-counter product to||
0245|024|H|self-treat, read and follow all directions on the product package||
0245|025|H|before using this medication. If your doctor has prescribed this||
0245|026|H|medication, read the Patient Information Leaflet before you start||
0245|027|H|using fluticasone and each time you get a refill. If you have any||
0245|028|H|questions, ask your doctor or pharmacist.||
0245|029|H|   Use this medication in the nose as directed by your doctor or||
0245|030|H|the product package, usually once or twice a day. Do not spray in||
0245|031|H|your eyes.||
0245|032|H|   Gently blow your nose before using this drug. Shake the||
0245|033|H|container gently before each use. Follow the instructions on how||
0245|034|H|to properly prime the bottle if you are using it for the first||
0245|035|H|time or if you have not used it for a week or longer.||
0245|036|H|   The dosage is based on your age, medical condition, and||
0245|037|H|response to treatment. Do not increase your dose or use this drug||
0245|038|H|more often or for longer than directed. Your condition will not||
0245|039|H|improve any faster, and your risk of side effects will increase.||
0245|040|H|You may be directed to start with a higher dose of this drug for||
0245|041|H|the first several days until you have begun to feel better, then||
0245|042|H|decrease your dose. Children may need to use this drug for a||
0245|043|H|shorter amount of time to lower the risk of side effects. If a||
0245|044|H|child is using the over-the-counter product, read the package||
0245|045|H|information to see how long he/she should use it and when you||
0245|046|H|should check with the doctor.||
0245|047|H|   Use this medication regularly to get the most benefit from it.||
0245|048|H|To help you remember, use it at the same time(s) each day.||
0245|049|H|   Clean the applicator regularly. Keep track of the number of||
0245|050|H|sprays used from the container. Discard the container after you||
0245|051|H|have used the number of sprays on the package label.||
0245|052|H|   This medication does not work right away. You may feel an||
0245|053|H|effect as soon as 12 hours after starting treatment, but it may||
0245|054|H|take several days before you get the full benefit. Tell your||
0245|055|H|doctor if your condition does not get better after 1 week or if||
0245|056|H|it gets worse. If you think you may have a serious medical||
0245|057|H|problem, get medical help right away.||
0245|058|B|||
0245|059|S|SIDE EFFECTS:  Nasal dryness/irritation, nausea, or vomiting may||
0245|060|S|occur. If any of these effects last or get worse, tell your||
0245|061|S|doctor or pharmacist promptly.||
0245|062|S|   If your doctor has directed you to use this medication,||
0245|063|S|remember that your doctor has judged that the benefit to you is||
0245|064|S|greater than the risk of side effects. Many people using this||
0245|065|S|medication do not have serious side effects.||
0245|066|S|   Tell your doctor right away if you have any serious side||
0245|067|S|effects, including: sore throat that doesn't go away, eye pain,||
0245|068|S|facial pain, signs of nasal damage (such as pain, severe||
0245|069|S|nosebleeds, a constant whistling sound from your nose), white||
0245|070|S|patches in your nose/back of your throat, pain when swallowing.||
0245|071|S|   Rarely, it is possible that corticosteroids given in the nose||
0245|072|S|will be absorbed into the bloodstream. This can lead to side||
0245|073|S|effects of too much corticosteroid. These side effects are more||
0245|074|S|likely in children and people who use this medication for a long||
0245|075|S|time and in high doses. Tell your doctor right away if any of the||
0245|076|S|following side effects occur: unusual/extreme tiredness, weight||
0245|077|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
0245|078|S|vision problems.||
0245|079|S|   A very serious allergic reaction to this drug is rare.||
0245|080|S|However, get medical help right away if you notice any symptoms||
0245|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0245|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0245|083|S|breathing.||
0245|084|S|   This is not a complete list of possible side effects. If you||
0245|085|S|notice other effects not listed above, contact your doctor or||
0245|086|S|pharmacist.||
0245|087|S|   In the US -||
0245|088|S|   Call your doctor for medical advice about side effects. You||
0245|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0245|090|S|www.fda.gov/medwatch.||
0245|091|S|   In Canada - Call your doctor for medical advice about side||
0245|092|S|effects. You may report side effects to Health Canada at||
0245|093|S|1-866-234-2345.||
0245|094|B|||
0245|095|P|PRECAUTIONS:  Before using fluticasone, tell your doctor or||
0245|096|P|pharmacist if you are allergic to it; or if you have any other||
0245|097|P|allergies. This product may contain inactive ingredients, which||
0245|098|P|can cause allergic reactions or other problems. Talk to your||
0245|099|P|pharmacist for more details.||
0245|100|P|   Before using this medication, tell your doctor or pharmacist||
0245|101|P|your medical history, especially of: recent nose problems (such||
0245|102|P|as injury, ulcers, surgery), infections (including tuberculosis,||
0245|103|P|herpes eye infection), certain eye problems (glaucoma,||
0245|104|P|cataracts), liver disease.||
0245|105|P|   Stay away from anyone who has an infection that may easily||
0245|106|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0245|107|P|doctor if you have been exposed to an infection or for more||
0245|108|P|details.||
0245|109|P|   Rarely, using corticosteroid medications for a long time can||
0245|110|P|make it more difficult for your body to respond to physical||
0245|111|P|stress. Before having surgery or emergency treatment, or if you||
0245|112|P|get a serious illness/injury, tell your doctor or dentist that||
0245|113|P|you are using this medication or have used this medication within||
0245|114|P|the past few months.||
0245|115|P|   Though it is unlikely, this medication may temporarily slow||
0245|116|P|down a child's growth if used for a long time. See the doctor||
0245|117|P|regularly so your child's height can be checked.||
0245|118|P|   During pregnancy, this medication should be used only when||
0245|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
0245|120|P|   It is unknown if this drug passes into breast milk. Consult||
0245|121|P|your doctor before breastfeeding.||
0245|122|B|||
0245|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0245|124|I|medications work or increase your risk for serious side effects.||
0245|125|I|This document does not contain all possible drug interactions.||
0245|126|I|Keep a list of all the products you use (including||
0245|127|I|prescription/nonprescription drugs and herbal products) and share||
0245|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
0245|129|I|the dosage of any medicines without your doctor's approval.||
0245|130|I|   Other medications can affect the removal of fluticasone from||
0245|131|I|your body, which may affect how fluticasone works. Examples||
0245|132|I|include HIV protease inhibitors (such as lopinavir), ritonavir,||
0245|133|I|among others.||
0245|134|B|||
0245|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0245|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0245|137|O|poison control center right away. US residents can call||
0245|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0245|139|B|||
0245|140|N|NOTES:  Do not share this medication with others.||
0245|141|N|   If you use this medication for a long time, lab and/or medical||
0245|142|N|tests (such as nose exams, height measurement in children) may be||
0245|143|N|done while you are using this medication. Keep all medical and||
0245|144|N|lab appointments. Consult your doctor for more details.||
0245|145|N|   Avoid substances (such as pollen, pet dander, dust mites,||
0245|146|N|mold, and smoke) that can worsen allergy symptoms.||
0245|147|B|||
0245|148|D|MISSED DOSE:  If you are using this product on a regular schedule||
0245|149|D|and miss a dose, use it as soon as you remember. If it is near||
0245|150|D|the time of the next dose, skip the missed dose. Use your next||
0245|151|D|dose at the regular time. Do not double the dose to catch up.||
0245|152|B|||
0245|153|R|STORAGE:  Different brands of this medication have different||
0245|154|R|storage needs. Check the product package for instructions on how||
0245|155|R|to store your brand, or ask your pharmacist. Keep all medications||
0245|156|R|away from children and pets.||
0245|157|R|   Do not flush medications down the toilet or pour them into a||
0245|158|R|drain unless instructed to do so. Properly discard this product||
0245|159|R|when it is expired or no longer needed. Consult your pharmacist||
0245|160|R|or local waste disposal company.||
0245|161|B|||
0245|162|A|Information last revised November 2024.||
0245|163|A|Copyright(c) 2025 First Databank, Inc.||
0245|164|B|||
0246|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0246|002|Z|does NOT have all possible information about this product. This||
0246|003|Z|information does not assure that this product is safe, effective,||
0246|004|Z|or appropriate for you. This information is not individual||
0246|005|Z|medical advice and does not substitute for the advice of your||
0246|006|Z|health care professional. Always ask your health care||
0246|007|Z|professional for complete information about this product and your||
0246|008|Z|specific health needs.||
0246|009|B|||
0246|010|T|ANTIHEMOPHILIC FACTOR (FACTOR VIII), HUMAN - INJECTION||
0246|011|F|(AN-tye-HEE-moe-FIL-ik-FAK-tor)||
0246|012|B|||
0246|013|C|COMMON BRAND NAME(S): Alphanate||
0246|014|B|||
0246|015|U|USES:  This medication is used to control and prevent bleeding||
0246|016|U|episodes in people with low levels of factor VIII (hemophilia A).||
0246|017|U|It is also used in these patients before surgery to prevent||
0246|018|U|bleeding. People with low factor VIII levels are at risk for||
0246|019|U|bleeding longer after an injury/surgery and for bleeding inside||
0246|020|U|the body (especially into the joints and muscles). This product||
0246|021|U|contains human factor VIII, also called antihemophilic factor.||
0246|022|U|This product is used to temporarily replace the missing factor||
0246|023|U|VIII, a protein (clotting factor) that is normally in the blood,||
0246|024|U|so that the blood can clot and the bleeding can stop.||
0246|025|B|||
0246|026|H|HOW TO USE:  This medication is given by injection into a vein as||
0246|027|H|directed by your doctor, usually over 5 to 10 minutes. The||
0246|028|H|medication may need to be given more slowly over a longer time||
0246|029|H|depending on your dose and how you respond to it.||
0246|030|H|   After first receiving this medication in a hemophilia||
0246|031|H|treatment center or hospital, some patients may be able to give||
0246|032|H|this medication to themselves at home. If your doctor directs you||
0246|033|H|to give this medication at home, read the product information||
0246|034|H|available from your pharmacist before you start using this||
0246|035|H|medication and each time you get a refill. Learn all preparation||
0246|036|H|and usage instructions in the product package. If you have any||
0246|037|H|questions, ask your health care professional.||
0246|038|H|   If the medication and the solution used to mix it have been||
0246|039|H|refrigerated, bring both to room temperature before combining.||
0246|040|H|After adding the solution to the powder, some brands of this||
0246|041|H|medication may require you to shake the vial for 10 to 15 seconds||
0246|042|H|before gently swirling the vial to completely dissolve the||
0246|043|H|powder. Other brands do not recommend shaking the vial. Ask your||
0246|044|H|pharmacist about the proper way to mix your medication. Before||
0246|045|H|using, check this product for particles or discoloration. If||
0246|046|H|either is present, do not use the liquid. Use the mixed||
0246|047|H|medication right away.||
0246|048|H|   The dosage is based on your medical condition, weight, blood||
0246|049|H|test results, and response to treatment. Follow your doctor's||
0246|050|H|instructions closely. Ask your doctor or pharmacist if you have||
0246|051|H|any questions.||
0246|052|H|   Learn how to store and discard needles and medical supplies||
0246|053|H|safely. Consult your pharmacist.||
0246|054|H|   Tell your doctor if your condition does not get better or if||
0246|055|H|it gets worse.||
0246|056|B|||
0246|057|S|SIDE EFFECTS:  Flushing of the face, nausea, vomiting, and fast||
0246|058|S|heartbeat may sometimes occur and can be lessened by giving this||
0246|059|S|medication more slowly. Burning/redness/irritation at the||
0246|060|S|injection site, fever, chills, and headache may also occur. If||
0246|061|S|any of these effects last or get worse, tell your doctor or||
0246|062|S|pharmacist promptly.||
0246|063|S|   Remember that this medication has been prescribed because your||
0246|064|S|doctor has judged that the benefit to you is greater than the||
0246|065|S|risk of side effects. Many people using this medication do not||
0246|066|S|have serious side effects.||
0246|067|S|   Tell your doctor right away if you have any serious side||
0246|068|S|effects, including: signs of anemia (such as tiredness, low||
0246|069|S|energy, pale skin color, shortness of breath), new or worsening||
0246|070|S|bleeding/bruising.||
0246|071|S|   A very serious allergic reaction to this drug is rare.||
0246|072|S|However, get medical help right away if you notice any symptoms||
0246|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0246|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0246|075|S|breathing, chest discomfort/tightness.||
0246|076|S|   This is not a complete list of possible side effects. If you||
0246|077|S|notice other effects not listed above, contact your doctor or||
0246|078|S|pharmacist.||
0246|079|S|   In the US -||
0246|080|S|   Call your doctor for medical advice about side effects. You||
0246|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0246|082|S|www.fda.gov/medwatch.||
0246|083|S|   In Canada - Call your doctor for medical advice about side||
0246|084|S|effects. You may report side effects to Health Canada at||
0246|085|S|1-866-234-2345.||
0246|086|B|||
0246|087|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0246|088|P|pharmacist if you are allergic to any antihemophilic factor||
0246|089|P|(factor VIII) products; or to natural rubber/latex (found in the||
0246|090|P|packaging of some brands); or if you have any other allergies.||
0246|091|P|This product may contain inactive ingredients, which can cause||
0246|092|P|allergic reactions or other problems. Talk to your pharmacist for||
0246|093|P|more details.||
0246|094|P|   Before using this medication, tell your doctor or pharmacist||
0246|095|P|your medical history.||
0246|096|P|   Manufacturers of some brands of this medication recommend that||
0246|097|P|you monitor your heartbeat during treatment. If your heart starts||
0246|098|P|to beat faster, it is recommended that you give this medication||
0246|099|P|more slowly or temporarily stop the infusion until your heart||
0246|100|P|rate returns to normal. Consult your doctor for more details.||
0246|101|P|   This medication is made from human blood. Even though the||
0246|102|P|blood is carefully tested, and this medication goes through a||
0246|103|P|special manufacturing process, there is an extremely small chance||
0246|104|P|that you may get infections from the medication (for example,||
0246|105|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
0246|106|P|more information.||
0246|107|P|   During pregnancy, this medication should be used only when||
0246|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
0246|109|P|   It is unknown if this drug passes into breast milk. Consult||
0246|110|P|your doctor before breastfeeding.||
0246|111|B|||
0246|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0246|113|I|medications work or increase your risk for serious side effects.||
0246|114|I|This document does not contain all possible drug interactions.||
0246|115|I|Keep a list of all the products you use (including||
0246|116|I|prescription/nonprescription drugs and herbal products) and share||
0246|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
0246|118|I|the dosage of any medicines without your doctor's approval.||
0246|119|B|||
0246|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0246|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0246|122|O|poison control center right away. US residents can call||
0246|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0246|124|B|||
0246|125|N|NOTES:  Do not share this medication with others.||
0246|126|N|   Lab tests (such as factor VIII levels) should be done while||
0246|127|N|you are using this medication. Keep all medical and lab||
0246|128|N|appointments. Consult your doctor for more details.||
0246|129|B|||
0246|130|D|MISSED DOSE:  It is important to follow the dosing schedule as||
0246|131|D|directed by your doctor. If you miss a dose, ask your doctor or||
0246|132|D|pharmacist right away for a new dosing schedule. Do not double||
0246|133|D|the dose to catch up.||
0246|134|B|||
0246|135|R|STORAGE:  Different brands of this medication have different||
0246|136|R|storage needs. Check the product package for instructions on how||
0246|137|R|to store your brand, or ask your pharmacist. Keep all medications||
0246|138|R|away from children and pets.||
0246|139|R|   Do not flush medications down the toilet or pour them into a||
0246|140|R|drain unless instructed to do so. Properly discard this product||
0246|141|R|when it is expired or no longer needed. Consult your pharmacist||
0246|142|R|or local waste disposal company.||
0246|143|B|||
0246|144|M|MEDICAL ALERT:  Your condition can cause complications in a||
0246|145|M|medical emergency. For information about enrolling in MedicAlert,||
0246|146|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0246|147|B|||
0246|148|A|Information last revised November 2024.||
0246|149|A|Copyright(c) 2025 First Databank, Inc.||
0246|150|B|||
0248|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0248|002|Z|does NOT have all possible information about this product. This||
0248|003|Z|information does not assure that this product is safe, effective,||
0248|004|Z|or appropriate for you. This information is not individual||
0248|005|Z|medical advice and does not substitute for the advice of your||
0248|006|Z|health care professional. Always ask your health care||
0248|007|Z|professional for complete information about this product and your||
0248|008|Z|specific health needs.||
0248|009|B|||
0248|010|T|BENZOIN - TOPICAL||
0248|011|F|(BEN-zoyn)||
0248|012|B|||
0248|013|U|USES:  This product is used on minor skin sores and wounds to||
0248|014|U|protect the area from irritation and infection. Benzoin is also||
0248|015|U|used on canker sores in and around the mouth to protect them so||
0248|016|U|they can heal.||
0248|017|U|   Benzoin is also used to help relieve and soothe minor||
0248|018|U|irritation of the nose, throat, and airways (such as laryngitis,||
0248|019|U|croup) when it is mixed with hot water and the steam is inhaled.||
0248|020|B|||
0248|021|H|HOW TO USE:  If you are using the over-the-counter product to||
0248|022|H|self-treat, read and follow all directions on the product package||
0248|023|H|before using this medication. If you have any questions, consult||
0248|024|H|your pharmacist. If your doctor has prescribed this medication,||
0248|025|H|use it as directed.||
0248|026|H|   When this product is used on the skin, clean and dry the||
0248|027|H|affected area first. Then apply to skin as directed.||
0248|028|H|   If you are using the spray, shake the container well before||
0248|029|H|using.||
0248|030|H|   If you are using this product by inhalation, mix it with hot||
0248|031|H|water as directed and inhale the steam (vapors).||
0248|032|H|   Do not use large amounts, use this product more often, or use||
0248|033|H|it for a longer time than directed. Your condition will not clear||
0248|034|H|faster, but the chance for side effects may be increased.||
0248|035|H|   Do not use this product in children younger than 6 months||
0248|036|H|without talking to the doctor first.||
0248|037|H|   Do not drink or swallow this product. Avoid contact in or||
0248|038|H|around the eyes.||
0248|039|H|   Tell your doctor if your condition does not get better in a||
0248|040|H|few days or if it gets worse. If you think you may have a serious||
0248|041|H|medical problem, get medical help right away.||
0248|042|B|||
0248|043|S|SIDE EFFECTS:  Mild irritation, burning, or redness of the skin||
0248|044|S|may occur as your body adjusts to this product. If any of these||
0248|045|S|effects last or get worse, tell your doctor or pharmacist||
0248|046|S|promptly.||
0248|047|S|   If your doctor has prescribed this medication, remember that||
0248|048|S|your doctor has judged that the benefit to you is greater than||
0248|049|S|the risk of side effects. Many people using this medication do||
0248|050|S|not have serious side effects.||
0248|051|S|   A very serious allergic reaction to this drug is rare.||
0248|052|S|However, get medical help right away if you notice any symptoms||
0248|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0248|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0248|055|S|breathing.||
0248|056|S|   This is not a complete list of possible side effects. If you||
0248|057|S|notice other effects not listed above, contact your doctor or||
0248|058|S|pharmacist.||
0248|059|S|   In the US -||
0248|060|S|   Call your doctor for medical advice about side effects. You||
0248|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0248|062|S|www.fda.gov/medwatch.||
0248|063|S|   In Canada - Call your doctor for medical advice about side||
0248|064|S|effects. You may report side effects to Health Canada at||
0248|065|S|1-866-234-2345.||
0248|066|B|||
0248|067|P|PRECAUTIONS:  Before using benzoin, tell your doctor or||
0248|068|P|pharmacist if you are allergic to it; or if you have any other||
0248|069|P|allergies. This product may contain inactive ingredients, which||
0248|070|P|can cause allergic reactions or other problems. Talk to your||
0248|071|P|pharmacist for more details.||
0248|072|P|   If you have any of the following health problems, consult your||
0248|073|P|doctor or pharmacist before using this product: current||
0248|074|P|infection.||
0248|075|P|   This product contains a large amount of alcohol. Carefully||
0248|076|P|watch children while they are using this product.||
0248|077|P|   During pregnancy, this product should be used only when||
0248|078|P|clearly needed. Discuss the risks and benefits with your doctor.||
0248|079|P|   It is unknown if this drug passes into breast milk. Consult||
0248|080|P|your doctor before breastfeeding.||
0248|081|B|||
0248|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0248|083|I|medications work or increase your risk for serious side effects.||
0248|084|I|This document does not contain all possible drug interactions.||
0248|085|I|Keep a list of all the products you use (including||
0248|086|I|prescription/nonprescription drugs and herbal products) and share||
0248|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
0248|088|I|the dosage of any medicines without your doctor's approval.||
0248|089|B|||
0248|090|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0248|091|O|has overdosed and has serious symptoms such as passing out or||
0248|092|O|trouble breathing, call 911. Otherwise, call a poison control||
0248|093|O|center right away. US residents can call 1-800-222-1222. Canada||
0248|094|O|residents can call 1-844-764-7669.||
0248|095|B|||
0248|096|N|NOTES:  Keep all medical and lab appointments.||
0248|097|B|||
0248|098|D|MISSED DOSE:  If you are using this product on a regular schedule||
0248|099|D|and miss a dose, use it as soon as you remember. If it is near||
0248|100|D|the time of the next dose, skip the missed dose. Use your next||
0248|101|D|dose at the regular time. Do not double the dose to catch up.||
0248|102|B|||
0248|103|R|STORAGE:  Store at room temperature away from direct sunlight.||
0248|104|R|This product is flammable. Keep it away from heat and open flame.||
0248|105|R|Refer to storage information printed on the package. If you have||
0248|106|R|any questions about storage, ask your pharmacist. Keep all||
0248|107|R|medications away from children and pets.||
0248|108|R|   Do not flush medications down the toilet or pour them into a||
0248|109|R|drain unless instructed to do so. Properly discard this product||
0248|110|R|when it is expired or no longer needed. Consult your pharmacist||
0248|111|R|or local waste disposal company.||
0248|112|B|||
0248|113|A|Information last revised July 2025.||
0248|114|A|Copyright(c) 2025 First Databank, Inc.||
0248|115|B|||
0249|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0249|002|Z|does NOT have all possible information about this product. This||
0249|003|Z|information does not assure that this product is safe, effective,||
0249|004|Z|or appropriate for you. This information is not individual||
0249|005|Z|medical advice and does not substitute for the advice of your||
0249|006|Z|health care professional. Always ask your health care||
0249|007|Z|professional for complete information about this product and your||
0249|008|Z|specific health needs.||
0249|009|B|||
0249|010|T|IRON DEXTRAN - INJECTION||
0249|011|F|(EYE-urn DEX-tran)||
0249|012|B|||
0249|013|C|COMMON BRAND NAME(S): Dexferrum, INFeD||
0249|014|B|||
0249|015|W|WARNING:  Rarely, iron dextran for injection has caused severe||
0249|016|W|(sometimes fatal) allergic reactions. It should be used only when||
0249|017|W|clearly needed and when a patient is unable to take iron by mouth||
0249|018|W|(oral forms).||
0249|019|W|   Get medical help right away if you experience signs of an||
0249|020|W|allergic reaction such as trouble breathing, dizziness, rash, or||
0249|021|W|itchy skin.||
0249|022|B|||
0249|023|U|USES:  This medication is used to treat "iron-poor" blood||
0249|024|U|(anemia) in people who cannot take iron by mouth because of side||
0249|025|U|effects or because their anemia has not been successfully treated||
0249|026|U|by it. Low iron levels can occur when the body can't get enough||
0249|027|U|iron from food (poor nutrition, poor absorption) or when there is||
0249|028|U|a large or long-term blood loss (for example, due to hemophilia,||
0249|029|U|stomach bleeding). It is also used by people who have anemia due||
0249|030|U|to long-term kidney disease.||
0249|031|U|   Iron is an important part of your red blood cells and is||
0249|032|U|needed to carry oxygen in the body.||
0249|033|B|||
0249|034|H|HOW TO USE:  This medication is usually injected deep into the||
0249|035|H|muscle of the buttock or slowly into a vein as directed by your||
0249|036|H|doctor. When injecting into the buttock, the next injection is||
0249|037|H|given on the opposite side from the last injection.||
0249|038|H|   Before the first full dose, a smaller test dose is given||
0249|039|H|slowly to check for possible allergic effects. If no reaction is||
0249|040|H|seen after one hour, the full dose may be given. You will be||
0249|041|H|checked carefully for reactions by a health care worker each time||
0249|042|H|you are getting the iron.||
0249|043|H|   Iron injections may be given once daily in small doses or as||
0249|044|H|directed by your doctor. Large doses may be given in a solution||
0249|045|H|and injected into a vein over several hours. Some side effects||
0249|046|H|such as dizziness and flushing may be stopped by giving the drug||
0249|047|H|more slowly. The dosage and length of treatment is based on your||
0249|048|H|age, weight, labs, medical condition, and response to treatment.||
0249|049|H|   If you are giving this medication to yourself at home, learn||
0249|050|H|all preparation and usage instructions from your health care||
0249|051|H|professional. Before using, check this product for particles or||
0249|052|H|discoloration. If either is present, do not use the liquid. Learn||
0249|053|H|how to store and discard medical supplies safely.||
0249|054|B|||
0249|055|S|SIDE EFFECTS:  Flushing, tingling of the hands/feet, shivering,||
0249|056|S|or dizziness may occur. The area around the injection site may be||
0249|057|S|tender, irritated, or discolored (brown). If any of these effects||
0249|058|S|last or get worse, tell your doctor or pharmacist promptly.||
0249|059|S|   Some people may experience a delayed reaction 1 to 2 days||
0249|060|S|after their treatment. These side effects (such as||
0249|061|S|back/joint/muscle aches, chills, fever, headache,||
0249|062|S|nausea/vomiting) usually lessen within 3 to 4 days if the||
0249|063|S|medication was injected into a vein or within 3 to 7 days if the||
0249|064|S|medication was injected into a muscle. Tell your doctor if any of||
0249|065|S|these side effects last or get worse more than 4 to 7 days after||
0249|066|S|your treatment.||
0249|067|S|   Remember that this medication has been prescribed because your||
0249|068|S|doctor has judged that the benefit to you is greater than the||
0249|069|S|risk of side effects. Many people using this medication do not||
0249|070|S|have serious side effects.||
0249|071|S|   Tell your doctor right away if you have any serious side||
0249|072|S|effects, including: abdominal pain, fast/slow/irregular||
0249|073|S|heartbeat, severe headache, blurred vision.||
0249|074|S|   Get medical help right away if you have any very serious side||
0249|075|S|effects, including: chest pain, seizures.||
0249|076|S|   A very serious allergic reaction to this drug is rare.||
0249|077|S|However, get medical help right away if you notice any symptoms||
0249|078|S|of a serious allergic reaction, including: rash, itching/swelling||
0249|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0249|080|S|breathing.||
0249|081|S|   This is not a complete list of possible side effects. If you||
0249|082|S|notice other effects not listed above, contact your doctor or||
0249|083|S|pharmacist.||
0249|084|S|   In the US -||
0249|085|S|   Call your doctor for medical advice about side effects. You||
0249|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0249|087|S|www.fda.gov/medwatch.||
0249|088|S|   In Canada - Call your doctor for medical advice about side||
0249|089|S|effects. You may report side effects to Health Canada at||
0249|090|S|1-866-234-2345.||
0249|091|B|||
0249|092|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0249|093|P|pharmacist if you are allergic to it; or if you have any other||
0249|094|P|allergies. This product may contain inactive ingredients, which||
0249|095|P|can cause allergic reactions or other problems. Talk to your||
0249|096|P|pharmacist for more details.||
0249|097|P|   Before using this medication, tell your doctor or pharmacist||
0249|098|P|your medical history, especially of: severe allergic reactions,||
0249|099|P|asthma, bleeding problems (such as hemophilia), heart disease||
0249|100|P|(such as chest pain, heart attack, heart failure), Hodgkin's||
0249|101|P|disease, autoimmune disease (such as rheumatoid arthritis,||
0249|102|P|ankylosing spondylitis, lupus), kidney disease (such as||
0249|103|P|infection), liver disease.||
0249|104|P|   Before having surgery, tell your doctor or dentist about all||
0249|105|P|the products you use (including prescription drugs,||
0249|106|P|nonprescription drugs, and herbal products).||
0249|107|P|   During pregnancy, this medication should be used only when||
0249|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
0249|109|P|   This medication passes into breast milk and may have||
0249|110|P|undesirable effects on a nursing infant. Consult your doctor||
0249|111|P|before breastfeeding.||
0249|112|B|||
0249|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0249|114|I|medications work or increase your risk for serious side effects.||
0249|115|I|This document does not contain all possible drug interactions.||
0249|116|I|Keep a list of all the products you use (including||
0249|117|I|prescription/nonprescription drugs and herbal products) and share||
0249|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
0249|119|I|the dosage of any medicines without your doctor's approval.||
0249|120|I|   This medication may interfere with certain lab tests (such as||
0249|121|I|bilirubin, calcium, and clotting times), possibly causing false||
0249|122|I|test results. Make sure lab personnel and all your doctors know||
0249|123|I|you use this drug.||
0249|124|B|||
0249|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0249|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0249|127|O|poison control center right away. US residents can call||
0249|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0249|129|B|||
0249|130|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0249|131|N|iron) should be done while you are using this medication. Keep||
0249|132|N|all medical and lab appointments. Consult your doctor for more||
0249|133|N|details.||
0249|134|N|   It is important to maintain a well-balanced diet to ensure||
0249|135|N|adequate intake of iron, vitamins, and minerals. Good sources of||
0249|136|N|iron include meats (especially liver), eggs, raisins, figs,||
0249|137|N|broccoli, Brussels sprouts, beans, lentils, and iron-fortified or||
0249|138|N|enriched cereals. Follow any diet recommendations given to you by||
0249|139|N|your doctor.||
0249|140|B|||
0249|141|D|MISSED DOSE:  It is important to get each dose of this medication||
0249|142|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0249|143|D|right away for a new dosing schedule. Do not double the dose to||
0249|144|D|catch up.||
0249|145|B|||
0249|146|R|STORAGE:  Consult the product instructions and your pharmacist||
0249|147|R|for storage details. Keep all medications away from children and||
0249|148|R|pets.||
0249|149|R|   Do not flush medications down the toilet or pour them into a||
0249|150|R|drain unless instructed to do so. Properly discard this product||
0249|151|R|when it is expired or no longer needed. Consult your pharmacist||
0249|152|R|or local waste disposal company.||
0249|153|B|||
0249|154|A|Information last revised October 2025.||
0249|155|A|Copyright(c) 2025 First Databank, Inc.||
0249|156|B|||
0250|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0250|002|Z|does NOT have all possible information about this product. This||
0250|003|Z|information does not assure that this product is safe, effective,||
0250|004|Z|or appropriate for you. This information is not individual||
0250|005|Z|medical advice and does not substitute for the advice of your||
0250|006|Z|health care professional. Always ask your health care||
0250|007|Z|professional for complete information about this product and your||
0250|008|Z|specific health needs.||
0250|009|B|||
0250|010|T|FAMOTIDINE 10 MG - ORAL||
0250|011|F|(fa-MOE-ti-deen)||
0250|012|B|||
0250|013|C|COMMON BRAND NAME(S): Pepcid AC, Zantac-360||
0250|014|B|||
0250|015|U|USES:  Famotidine is known as an H2 blocker. It works by reducing||
0250|016|U|the amount of acid in your stomach. It is used to prevent and||
0250|017|U|treat heartburn and other symptoms caused by too much acid in the||
0250|018|U|stomach (acid indigestion).||
0250|019|U|   Check the ingredients on the label even if you have used the||
0250|020|U|product before. The manufacturer may have changed the||
0250|021|U|ingredients. Also, products with similar names may contain||
0250|022|U|different ingredients meant for different purposes. Taking the||
0250|023|U|wrong product could harm you.||
0250|024|B|||
0250|025|H|HOW TO USE:  To treat heartburn and acid indigestion, take 1||
0250|026|H|tablet or capsule with a glass of water as needed, unless||
0250|027|H|otherwise directed by your doctor. Swallow the tablets and||
0250|028|H|capsules whole without chewing. If you are using the chewable||
0250|029|H|tablets, chew completely and swallow one tablet as needed. Do not||
0250|030|H|swallow whole. Famotidine can be taken with or without food.||
0250|031|H|   To prevent heartburn and acid indigestion, take famotidine||
0250|032|H|15-60 minutes before eating food or drinking beverages that can||
0250|033|H|cause indigestion.||
0250|034|H|   Do not take more than 2 tablets in 24 hours unless directed by||
0250|035|H|your doctor. Follow all directions on the product package. If you||
0250|036|H|have any questions, ask your doctor or pharmacist.||
0250|037|H|   Tell your doctor if your symptoms last or if they get worse.||
0250|038|H|Do not take this medicine for more than 14 days in a row without||
0250|039|H|talking with your doctor.||
0250|040|B|||
0250|041|S|SIDE EFFECTS:  Headache, constipation or diarrhea may occur. If||
0250|042|S|any of these effects last or get worse, tell your doctor or||
0250|043|S|pharmacist promptly.||
0250|044|S|   If your doctor has directed you to use this medication,||
0250|045|S|remember that your doctor has judged that the benefit to you is||
0250|046|S|greater than the risk of side effects. Many people using this||
0250|047|S|medication do not have serious side effects.||
0250|048|S|   Tell your doctor right away if you have any serious side||
0250|049|S|effects, including: easy bruising/bleeding, signs of infection||
0250|050|S|(such as sore throat that doesn't go away, fever, chills),||
0250|051|S|mental/mood changes (such as restlessness, confusion, depression,||
0250|052|S|hallucinations).||
0250|053|S|   Get medical help right away if you have any very serious side||
0250|054|S|effects, including: fast/slow/irregular heartbeat, severe||
0250|055|S|dizziness, fainting, seizure.||
0250|056|S|   A very serious allergic reaction to this drug is rare.||
0250|057|S|However, get medical help right away if you notice any symptoms||
0250|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0250|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0250|060|S|breathing.||
0250|061|S|   This is not a complete list of possible side effects. If you||
0250|062|S|notice other effects not listed above, contact your doctor or||
0250|063|S|pharmacist.||
0250|064|S|   In the US -||
0250|065|S|   Call your doctor for medical advice about side effects. You||
0250|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0250|067|S|www.fda.gov/medwatch.||
0250|068|S|   In Canada - Call your doctor for medical advice about side||
0250|069|S|effects. You may report side effects to Health Canada at||
0250|070|S|1-866-234-2345.||
0250|071|B|||
0250|072|P|PRECAUTIONS:  Before taking famotidine, tell your doctor or||
0250|073|P|pharmacist if you are allergic to it; or to other H2 blockers||
0250|074|P|(such as cimetidine, ranitidine); or if you have any other||
0250|075|P|allergies. This product may contain inactive ingredients, which||
0250|076|P|can cause allergic reactions or other problems. Talk to your||
0250|077|P|pharmacist for more details.||
0250|078|P|   If you have any of the following health problems, consult your||
0250|079|P|doctor or pharmacist before using this medication: kidney||
0250|080|P|problems, liver problems, other stomach problems (such as||
0250|081|P|tumors).||
0250|082|P|   Some symptoms may actually be signs of a more serious||
0250|083|P|condition. Get medical help right away if you have: heartburn||
0250|084|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
0250|085|P|pain (especially with shortness of breath, unusual sweating),||
0250|086|P|unexplained weight loss.||
0250|087|P|   In addition, before you self-treat with this medication, get||
0250|088|P|medical help right away if you have any of these signs of a||
0250|089|P|serious condition: trouble/pain swallowing food, bloody vomit,||
0250|090|P|vomit that looks like coffee grounds, bloody/black stools,||
0250|091|P|heartburn for over 3 months, frequent chest pain, frequent||
0250|092|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
0250|093|P|pain.||
0250|094|P|   This chewable form of this medication contains aspartame. If||
0250|095|P|you have phenylketonuria (PKU) or any other condition that||
0250|096|P|requires you to restrict your intake of aspartame (or||
0250|097|P|phenylalanine), consult your doctor or pharmacist regarding the||
0250|098|P|safe use of this medication.||
0250|099|P|   Do not use this medication in children younger than 12 unless||
0250|100|P|directed by the doctor.||
0250|101|P|   Older adults may be more sensitive to the side effects of this||
0250|102|P|drug, especially mental/mood changes (such as confusion),||
0250|103|P|seizure, or unusual tiredness.||
0250|104|P|   During pregnancy, this medication should only be used if||
0250|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
0250|106|P|Tell your doctor if you are pregnant before using this||
0250|107|P|medication.||
0250|108|P|   This drug passes into breast milk. Consult your doctor before||
0250|109|P|breastfeeding.||
0250|110|B|||
0250|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0250|112|I|medications work or increase your risk for serious side effects.||
0250|113|I|This document does not contain all possible drug interactions.||
0250|114|I|Keep a list of all the products you use (including||
0250|115|I|prescription/nonprescription drugs and herbal products) and share||
0250|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
0250|117|I|the dosage of any medicines without your doctor's approval.||
0250|118|I|   A product that may interact with this drug is: fezolinetant.||
0250|119|I|   Some products need stomach acid so that the body can absorb||
0250|120|I|them properly. Famotidine decreases stomach acid, so it may||
0250|121|I|change how well these products work. Some affected products||
0250|122|I|include atazanavir, dasatinib, certain azole antifungals (such as||
0250|123|I|itraconazole, ketoconazole), levoketoconazole, pazopanib,||
0250|124|I|sparsentan, among others.||
0250|125|I|   Do not take this medication with other products that contain||
0250|126|I|famotidine or other H2 blockers (cimetidine, nizatidine,||
0250|127|I|ranitidine).||
0250|128|B|||
0250|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0250|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0250|131|O|poison control center right away. US residents can call||
0250|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0250|133|B|||
0250|134|N|NOTES:  Lifestyle changes such as stress reduction programs,||
0250|135|N|stopping smoking, limiting alcohol, and diet changes (such as||
0250|136|N|avoiding caffeine and certain spices) may help this medication||
0250|137|N|work better. Talk to your doctor or pharmacist about lifestyle||
0250|138|N|changes that might benefit you.||
0250|139|B|||
0250|140|D|MISSED DOSE:  Not applicable.||
0250|141|B|||
0250|142|R|STORAGE:  Store at room temperature away from light and moisture.||
0250|143|R|Do not store in the bathroom. Keep all medications away from||
0250|144|R|children and pets.||
0250|145|R|   Do not flush medications down the toilet or pour them into a||
0250|146|R|drain unless instructed to do so. Properly discard this product||
0250|147|R|when it is expired or no longer needed. Consult your pharmacist||
0250|148|R|or local waste disposal company.||
0250|149|B|||
0250|150|A|Information last revised November 2024.||
0250|151|A|Copyright(c) 2025 First Databank, Inc.||
0250|152|B|||
0251|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0251|002|Z|does NOT have all possible information about this product. This||
0251|003|Z|information does not assure that this product is safe, effective,||
0251|004|Z|or appropriate for you. This information is not individual||
0251|005|Z|medical advice and does not substitute for the advice of your||
0251|006|Z|health care professional. Always ask your health care||
0251|007|Z|professional for complete information about this product and your||
0251|008|Z|specific health needs.||
0251|009|B|||
0251|010|T|OLMESARTAN - ORAL||
0251|011|F|(OL-me-SAR-tan)||
0251|012|B|||
0251|013|C|COMMON BRAND NAME(S): Benicar||
0251|014|B|||
0251|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
0251|016|W|unborn baby if used during pregnancy. It is important to prevent||
0251|017|W|pregnancy while taking this medication. Consult your doctor for||
0251|018|W|more details and to discuss the use of reliable forms of birth||
0251|019|W|control while taking this medication. If you are planning||
0251|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
0251|021|W|your doctor right away.||
0251|022|B|||
0251|023|U|USES:  Olmesartan is used to treat high blood pressure||
0251|024|U|(hypertension). Lowering high blood pressure helps prevent||
0251|025|U|strokes, heart attacks, and kidney problems. Olmesartan belongs||
0251|026|U|to a class of drugs called angiotensin receptor blockers (ARBs).||
0251|027|U|It works by relaxing blood vessels so that blood can flow more||
0251|028|U|easily.||
0251|029|B|||
0251|030|V|OTHER USES:  This section contains uses of this drug that are not||
0251|031|V|listed in the approved professional labeling for the drug but||
0251|032|V|that may be prescribed by your health care professional. Use this||
0251|033|V|drug for a condition that is listed in this section only if it||
0251|034|V|has been so prescribed by your health care professional.||
0251|035|V|   This drug may also be used for heart failure. It may also be||
0251|036|V|used for kidney disease.||
0251|037|B|||
0251|038|H|HOW TO USE:  Take this medication by mouth as directed by your||
0251|039|H|doctor, usually once daily with or without food. The dosage is||
0251|040|H|based on your medical condition and response to treatment.||
0251|041|H|   If you are using the liquid form of this medication, shake the||
0251|042|H|bottle well before each dose. Carefully measure the dose using a||
0251|043|H|special measuring device/spoon. Do not use a household spoon||
0251|044|H|because you may not get the correct dose.||
0251|045|H|   If you also take certain drugs to lower your cholesterol (bile||
0251|046|H|acid-binding resins such as cholestyramine, colesevelam,||
0251|047|H|colestipol), take olmesartan at least 4 hours before any of these||
0251|048|H|medications.||
0251|049|H|   Use this medication regularly to get the most benefit from it.||
0251|050|H|To help you remember, take it at the same time each day. Keep||
0251|051|H|taking this medication even if you feel well. Most people with||
0251|052|H|high blood pressure do not feel sick.||
0251|053|H|   Tell your doctor if your condition does not get better or if||
0251|054|H|it gets worse (your blood pressure readings remain high or||
0251|055|H|increase).||
0251|056|B|||
0251|057|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
0251|058|S|body adjusts to the medication. If any of these effects last or||
0251|059|S|get worse, tell your doctor or pharmacist promptly.||
0251|060|S|   To reduce the risk of dizziness and lightheadedness, get up||
0251|061|S|slowly when rising from a sitting or lying position.||
0251|062|S|   Remember that this medication has been prescribed because your||
0251|063|S|doctor has judged that the benefit to you is greater than the||
0251|064|S|risk of side effects. Many people using this medication do not||
0251|065|S|have serious side effects.||
0251|066|S|   Tell your doctor right away if you have any serious side||
0251|067|S|effects, including: diarrhea that is severe or doesn't stop,||
0251|068|S|fainting, symptoms of a high potassium blood level (such as||
0251|069|S|muscle weakness, slow/irregular heartbeat).||
0251|070|S|   Although olmesartan may be used to prevent kidney problems or||
0251|071|S|treat people who have kidney problems, it may also rarely cause||
0251|072|S|serious kidney problems or make them worse. Your doctor will||
0251|073|S|check your kidney function while you are taking olmesartan. Tell||
0251|074|S|your doctor right away if you have any signs of kidney problems||
0251|075|S|such as a change in the amount of urine.||
0251|076|S|   A very serious allergic reaction to this drug is rare.||
0251|077|S|However, get medical help right away if you notice any symptoms||
0251|078|S|of a serious allergic reaction, including: rash, itching/swelling||
0251|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0251|080|S|breathing.||
0251|081|S|   This is not a complete list of possible side effects. If you||
0251|082|S|notice other effects not listed above, contact your doctor or||
0251|083|S|pharmacist.||
0251|084|S|   In the US -||
0251|085|S|   Call your doctor for medical advice about side effects. You||
0251|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0251|087|S|www.fda.gov/medwatch.||
0251|088|S|   In Canada - Call your doctor for medical advice about side||
0251|089|S|effects. You may report side effects to Health Canada at||
0251|090|S|1-866-234-2345.||
0251|091|B|||
0251|092|P|PRECAUTIONS:  Before taking olmesartan, tell your doctor or||
0251|093|P|pharmacist if you are allergic to it; or if you have any other||
0251|094|P|allergies. This product may contain inactive ingredients, which||
0251|095|P|can cause allergic reactions or other problems. Talk to your||
0251|096|P|pharmacist for more details.||
0251|097|P|   Before using this medication, tell your doctor or pharmacist||
0251|098|P|your medical history, especially of: kidney disease, liver||
0251|099|P|disease, dehydration, high level of potassium in the blood.||
0251|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0251|101|P|can make you more dizzy. Do not drive, use machinery, or do||
0251|102|P|anything that needs alertness until you can do it safely. Limit||
0251|103|P|alcoholic beverages. Talk to your doctor if you are using||
0251|104|P|marijuana (cannabis).||
0251|105|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0251|106|P|and cause you to feel lightheaded. Tell your doctor if you have||
0251|107|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0251|108|P|of fluids unless your doctor tells you not to.||
0251|109|P|   This medication may increase your potassium levels. Before||
0251|110|P|using potassium supplements or salt substitutes that contain||
0251|111|P|potassium, consult your doctor or pharmacist.||
0251|112|P|   Before having surgery, tell your doctor or dentist about all||
0251|113|P|the products you use (including prescription drugs,||
0251|114|P|nonprescription drugs, and herbal products).||
0251|115|P|   Tell your doctor if you are pregnant or plan to become||
0251|116|P|pregnant. You should not become pregnant while using olmesartan.||
0251|117|P|Olmesartan may harm an unborn baby. If you become pregnant, talk||
0251|118|P|to your doctor right away about the risks and benefits of this||
0251|119|P|medication. (See also Warning section.)||
0251|120|P|   It is unknown if this drug passes into breast milk. Consult||
0251|121|P|your doctor before breastfeeding.||
0251|122|B|||
0251|123|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
0251|124|I|   Drug interactions may change how your medications work or||
0251|125|I|increase your risk for serious side effects. This document does||
0251|126|I|not contain all possible drug interactions. Keep a list of all||
0251|127|I|the products you use (including prescription/nonprescription||
0251|128|I|drugs and herbal products) and share it with your doctor and||
0251|129|I|pharmacist. Do not start, stop, or change the dosage of any||
0251|130|I|medicines without your doctor's approval.||
0251|131|I|   Some products that may interact with this drug include:||
0251|132|I|aliskiren, lithium, drugs that may increase the level of||
0251|133|I|potassium in the blood (such as sparsentan, ACE inhibitors||
0251|134|I|including benazepril/lisinopril, birth control pills containing||
0251|135|I|drospirenone).||
0251|136|I|   Some products have ingredients that could raise your blood||
0251|137|I|pressure or worsen your heart failure. Tell your pharmacist what||
0251|138|I|products you are using, and ask how to use them safely||
0251|139|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0251|140|I|ibuprofen/naproxen).||
0251|141|B|||
0251|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0251|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0251|144|O|poison control center right away. US residents can call||
0251|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0251|146|O|Symptoms of overdose may include: severe dizziness, fainting.||
0251|147|B|||
0251|148|N|NOTES:  Do not share this medication with others.||
0251|149|N|   Lifestyle changes such as stress reduction programs, exercise,||
0251|150|N|and dietary changes may increase the effectiveness of this||
0251|151|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0251|152|N|changes that might benefit you.||
0251|153|N|   Lab and/or medical tests (such as kidney function, potassium||
0251|154|N|levels) should be done while you are taking this medication. Keep||
0251|155|N|all medical and lab appointments. Consult your doctor for more||
0251|156|N|details.||
0251|157|N|   Check your blood pressure regularly while taking this||
0251|158|N|medication. Learn how to monitor your own blood pressure, and||
0251|159|N|share the results with your doctor.||
0251|160|B|||
0251|161|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0251|162|D|remember. If it is near the time of the next dose, skip the||
0251|163|D|missed dose. Take your next dose at the regular time. Do not||
0251|164|D|double the dose to catch up.||
0251|165|B|||
0251|166|R|STORAGE:  Store tablets at room temperature away from light and||
0251|167|R|moisture. Do not store in the bathroom. Store the suspension in||
0251|168|R|the refrigerator. Do not freeze. Discard any unused suspension||
0251|169|R|after 4 weeks. Keep all medications away from children and pets.||
0251|170|R|   Do not flush medications down the toilet or pour them into a||
0251|171|R|drain unless instructed to do so. Properly discard this product||
0251|172|R|when it is expired or no longer needed. Consult your pharmacist||
0251|173|R|or local waste disposal company.||
0251|174|B|||
0251|175|A|Information last revised May 2024.||
0251|176|A|Copyright(c) 2025 First Databank, Inc.||
0251|177|B|||
0252|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0252|002|Z|does NOT have all possible information about this product. This||
0252|003|Z|information does not assure that this product is safe, effective,||
0252|004|Z|or appropriate for you. This information is not individual||
0252|005|Z|medical advice and does not substitute for the advice of your||
0252|006|Z|health care professional. Always ask your health care||
0252|007|Z|professional for complete information about this product and your||
0252|008|Z|specific health needs.||
0252|009|B|||
0252|010|T|LIDOCAINE JELLY - MUCOUS MEMBRANE||
0252|011|F|(LYE-doe-kane)||
0252|012|B|||
0252|013|C|COMMON BRAND NAME(S): Xylocaine||
0252|014|B|||
0252|015|U|USES:  This medication is used to prevent and relieve pain during||
0252|016|U|certain medical procedures (such as inserting a tube into the||
0252|017|U|urinary tract). It is also used to numb the lining of the mouth,||
0252|018|U|throat, or nose before certain medical procedures (such as||
0252|019|U|intubation). Lidocaine jelly is also used to relieve pain caused||
0252|020|U|by swelling of the urinary tract (urethritis). It works by||
0252|021|U|numbing certain areas of the body that are moist. Lidocaine||
0252|022|U|belongs to a class of drugs known as local anesthetics.||
0252|023|B|||
0252|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0252|025|H|from your pharmacist before you start using lidocaine and each||
0252|026|H|time you get a refill. If you have any questions, ask your doctor||
0252|027|H|or pharmacist.||
0252|028|H|   This medication is usually applied by a health care||
0252|029|H|professional to the area being treated or to the medical||
0252|030|H|equipment used during a medical procedure. It is usually applied||
0252|031|H|just before your procedure.||
0252|032|H|   If you are using this medication at home, learn all||
0252|033|H|preparation and usage instructions from your health care||
0252|034|H|professional and the product package. Follow your doctor's||
0252|035|H|instructions carefully. Clean the affected area before use, if||
0252|036|H|possible, and apply with clean hands as directed. Avoid getting||
0252|037|H|this medication in your eyes. Wash your hands after use. Throw||
0252|038|H|away any unused jelly after first use.||
0252|039|H|   The dosage is based on your medical condition and response to||
0252|040|H|treatment. Children's dosage is also based on age and weight. Do||
0252|041|H|not use more than 4 doses in a 24-hour period. Do not increase||
0252|042|H|your dose or use this drug more often or for longer than||
0252|043|H|prescribed. Doing so can increase your risk of serious side||
0252|044|H|effects.||
0252|045|H|   When this medication is used in the mouth or throat, numbness||
0252|046|H|may make swallowing difficult and increase your risk of||
0252|047|H|swallowing the wrong way or choking. Do not chew gum or eat for 1||
0252|048|H|hour after using this product and while your mouth or throat is||
0252|049|H|numb. It is especially important for children to not eat or chew||
0252|050|H|gum for at least 1 hour after their procedures. Be careful not to||
0252|051|H|accidentally bite your tongue or mouth.||
0252|052|H|   Lidocaine starts to numb the affected area within 5 minutes||
0252|053|H|after application. If you are using this product before certain||
0252|054|H|procedures, tell your doctor if the area does not feel numb or||
0252|055|H|the numbness does not go away. If you are using this product to||
0252|056|H|relieve pain/discomfort, tell your doctor if your condition lasts||
0252|057|H|or gets worse.||
0252|058|B|||
0252|059|S|SIDE EFFECTS:  Mild nausea, stinging, swelling, or burning may||
0252|060|S|occur. If any of these effects last or get worse, tell your||
0252|061|S|doctor or pharmacist promptly.||
0252|062|S|   Remember that this medication has been prescribed because your||
0252|063|S|doctor has judged that the benefit to you is greater than the||
0252|064|S|risk of side effects. Many people using this medication do not||
0252|065|S|have serious side effects.||
0252|066|S|   This medication may cause very serious side effects if you are||
0252|067|S|using too much of it or are very sensitive to its effects. Stop||
0252|068|S|using this medication and get medical help right away if you have||
0252|069|S|any very serious side effects, including: dizziness, drowsiness,||
0252|070|S|slow/shallow breathing, mental/mood changes (such as confusion,||
0252|071|S|nervousness), shaking, seizures, vision changes (such as||
0252|072|S|double/blurred vision), ringing in the ears, fainting,||
0252|073|S|pale/bluish/gray skin, unusual tiredness, shortness of breath,||
0252|074|S|fast/slow/irregular heartbeat.||
0252|075|S|   A very serious allergic reaction to this drug is rare.||
0252|076|S|However, get medical help right away if you notice any symptoms||
0252|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0252|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0252|079|S|breathing.||
0252|080|S|   This is not a complete list of possible side effects. If you||
0252|081|S|notice other effects not listed above, contact your doctor or||
0252|082|S|pharmacist.||
0252|083|S|   In the US -||
0252|084|S|   Call your doctor for medical advice about side effects. You||
0252|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0252|086|S|www.fda.gov/medwatch.||
0252|087|S|   In Canada - Call your doctor for medical advice about side||
0252|088|S|effects. You may report side effects to Health Canada at||
0252|089|S|1-866-234-2345.||
0252|090|B|||
0252|091|P|PRECAUTIONS:  Before using lidocaine, tell your doctor or||
0252|092|P|pharmacist if you are allergic to it; or to other anesthetics||
0252|093|P|(such as bupivacaine, prilocaine); or to PABA; or if you have any||
0252|094|P|other allergies. This product may contain inactive ingredients,||
0252|095|P|which can cause allergic reactions or other problems. Talk to||
0252|096|P|your pharmacist for more details.||
0252|097|P|   Before using this medication, tell your doctor or pharmacist||
0252|098|P|your medical history, especially of: cuts/sores/bleeding in the||
0252|099|P|area where this drug will be applied, heart problems (such as||
0252|100|P|slow/irregular heartbeat, heart block), kidney disease, liver||
0252|101|P|disease, a certain blood disorder (methemoglobinemia).||
0252|102|P|   This drug may make you dizzy or drowsy or cause vision||
0252|103|P|problems if you are using too much of it or are very sensitive to||
0252|104|P|its effects. See Side Effects section. Alcohol or marijuana||
0252|105|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0252|106|P|machinery, or do anything that needs alertness or clear vision||
0252|107|P|until you can do it safely. Limit alcoholic beverages. Talk to||
0252|108|P|your doctor if you are using marijuana (cannabis).||
0252|109|P|   Before having surgery, tell your doctor or dentist about all||
0252|110|P|the products you use (including prescription drugs,||
0252|111|P|nonprescription drugs, and herbal products).||
0252|112|P|   Children may be more sensitive to the side effects of this||
0252|113|P|drug, especially drowsiness and dizziness.||
0252|114|P|   During pregnancy, this medication should be used only when||
0252|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
0252|116|P|   This medication passes into breast milk, but is unlikely to||
0252|117|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0252|118|B|||
0252|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0252|120|I|medications work or increase your risk for serious side effects.||
0252|121|I|This document does not contain all possible drug interactions.||
0252|122|I|Keep a list of all the products you use (including||
0252|123|I|prescription/nonprescription drugs and herbal products) and share||
0252|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
0252|125|I|the dosage of any medicines without your doctor's approval.||
0252|126|I|   Tell your doctor or pharmacist if you are using other||
0252|127|I|lidocaine products at the same time as this medication because||
0252|128|I|your risk of serious side effects may increase.||
0252|129|B|||
0252|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0252|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0252|132|O|poison control center right away. US residents can call||
0252|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0252|134|O|Symptoms of overdose may include: vision/hearing changes, severe||
0252|135|O|dizziness/drowsiness, fainting, loss of consciousness, shaking,||
0252|136|O|seizures, slow/irregular heartbeat, slow/shallow breathing.||
0252|137|B|||
0252|138|N|NOTES:  Do not share this medication with others.||
0252|139|N|   This medication has been prescribed for your current condition||
0252|140|N|only. Do not use it later for another condition unless your||
0252|141|N|doctor directs you to do so. A different medication may be||
0252|142|N|necessary in that case.||
0252|143|B|||
0252|144|D|MISSED DOSE:  Not applicable.||
0252|145|B|||
0252|146|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
0252|147|R|medications away from children and pets.||
0252|148|R|   Do not flush medications down the toilet or pour them into a||
0252|149|R|drain unless instructed to do so. Properly discard this product||
0252|150|R|when it is expired or no longer needed. Consult your pharmacist||
0252|151|R|or local waste disposal company.||
0252|152|B|||
0252|153|A|Information last revised September 2024.||
0252|154|A|Copyright(c) 2025 First Databank, Inc.||
0252|155|B|||
0256|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0256|002|Z|does NOT have all possible information about this product. This||
0256|003|Z|information does not assure that this product is safe, effective,||
0256|004|Z|or appropriate for you. This information is not individual||
0256|005|Z|medical advice and does not substitute for the advice of your||
0256|006|Z|health care professional. Always ask your health care||
0256|007|Z|professional for complete information about this product and your||
0256|008|Z|specific health needs.||
0256|009|B|||
0256|010|T|BOTULINUM TOXIN - INJECTION||
0256|011|F|(BOT-ue-LYE-num)||
0256|012|B|||
0256|013|W|WARNING:  See also Uses section.||
0256|014|W|   This medication can spread to other parts of the body after||
0256|015|W|your injection, causing serious (possibly fatal) side effects.||
0256|016|W|These can occur hours or even weeks after the injection. However,||
0256|017|W|the chances of such serious side effects occurring when this||
0256|018|W|medication is used for migraines or skin conditions such as||
0256|019|W|wrinkles, eye spasm, or excessive sweating are extremely||
0256|020|W|unlikely.||
0256|021|W|   Children being treated for muscle stiffness/spasms have the||
0256|022|W|greatest risk of these effects, as well as anyone that has||
0256|023|W|certain medical conditions (see Precautions section). Discuss the||
0256|024|W|risks and benefits of this medication with your doctor.||
0256|025|W|   Get medical help right away if any of these very serious side||
0256|026|W|effects occur: chest pain, difficulty breathing, excessive muscle||
0256|027|W|weakness, irregular heartbeat, severe difficulty swallowing or||
0256|028|W|speaking, loss of bladder control.||
0256|029|B|||
0256|030|U|USES:  There are different types of botulinum toxin products||
0256|031|U|(toxin A and B) with different uses (eye problems, muscle||
0256|032|U|stiffness/spasms, migraines, cosmetic, overactive bladder).||
0256|033|U|Different brands of this medication deliver different amounts of||
0256|034|U|medication. Your doctor will choose the correct product for you.||
0256|035|U|   Botulinum toxin is used to treat certain eye disorders such as||
0256|036|U|crossed eyes (strabismus) and uncontrolled blinking||
0256|037|U|(blepharospasm), to treat muscle stiffness/spasms or movement||
0256|038|U|disorders (such as cervical dystonia, torticollis), and to reduce||
0256|039|U|the cosmetic appearance of wrinkles or vertical neck bands||
0256|040|U|connecting the jaw and neck (platysma bands). It is also used to||
0256|041|U|prevent headaches in people with very frequent migraines.||
0256|042|U|Botulinum toxin relaxes muscle by blocking the release of a||
0256|043|U|chemical called acetylcholine.||
0256|044|U|   Botulinum toxin is also used to treat overactive bladder by||
0256|045|U|patients who do not respond to or who cannot tolerate the side||
0256|046|U|effects of other medications. It helps to reduce leaking of||
0256|047|U|urine, feeling of needing to urinate right away, and frequent||
0256|048|U|trips to the bathroom.||
0256|049|U|   It is also used to treat severe underarm sweating and||
0256|050|U|drooling/excess saliva. Botulinum toxin works by blocking the||
0256|051|U|chemicals that turn on the sweat and salivary glands.||
0256|052|U|   Botulinum toxin is not a cure, and your symptoms will||
0256|053|U|gradually return as the medication wears off.||
0256|054|B|||
0256|055|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0256|056|H|Patient Information Leaflet provided by your pharmacist before||
0256|057|H|you start using this medication and each time you get an||
0256|058|H|injection. If you have any questions, ask your doctor or||
0256|059|H|pharmacist.||
0256|060|H|   This medication is given by injection by an experienced health||
0256|061|H|care professional. It is injected into the affected muscles when||
0256|062|H|treating eye disorders, muscle stiffness/spasms, platysma bands,||
0256|063|H|and wrinkles. When used to prevent migraines, it is injected into||
0256|064|H|the muscles of the head and neck. It is injected into the skin||
0256|065|H|for the treatment of excessive sweating. For the treatment of||
0256|066|H|drooling/excess saliva, this medication is injected into the||
0256|067|H|salivary glands. When treating overactive bladder, it is injected||
0256|068|H|into the bladder.||
0256|069|H|   The dosage, the number of injections, the site of injections,||
0256|070|H|and how often you receive the medication will be determined by||
0256|071|H|your condition and your response to treatment. Children's dosage||
0256|072|H|is also based on weight. Most people start to see an effect||
0256|073|H|within a few days to 2 weeks, and the effect usually lasts 3 to 6||
0256|074|H|months.||
0256|075|B|||
0256|076|S|SIDE EFFECTS:  See also Warning section.||
0256|077|S|   Because this medication is given at the site of your||
0256|078|S|condition, most of the side effects occur close to where the||
0256|079|S|medication is injected. Redness, bruising, infection, and pain at||
0256|080|S|the injection site may occur.||
0256|081|S|   Dizziness, mild difficulty swallowing, respiratory infections||
0256|082|S|such as cold or flu, pain, nausea, headache, and muscle weakness||
0256|083|S|may occur when this medication is used to relax muscles. Double||
0256|084|S|vision, drooping or swollen eyelid, eye irritation, dry eyes,||
0256|085|S|tearing, reduced blinking, and increased sensitivity to light may||
0256|086|S|also occur.||
0256|087|S|   If any of these effects last or get worse, notify your doctor||
0256|088|S|or pharmacist promptly. You may require protective eye||
0256|089|S|drops/ointments, an eye patch, or other treatment.||
0256|090|S|   When this medication is used to prevent migraines, side||
0256|091|S|effects such as headache, neck pain, and drooping eyelid may||
0256|092|S|occur.||
0256|093|S|   When this medication is used for excessive sweating, side||
0256|094|S|effects such as non-underarm sweating, respiratory infections||
0256|095|S|such as cold or flu, headache, fever, neck or back pain, and||
0256|096|S|anxiety may occur.||
0256|097|S|   When this medication is used for overactive bladder, side||
0256|098|S|effects such as urinary tract infections, burning/painful||
0256|099|S|urination, fever, or difficulty urinating may occur.||
0256|100|S|   If any of these effects last or get worse, notify your doctor||
0256|101|S|or pharmacist promptly.||
0256|102|S|   Remember that this medication has been prescribed because your||
0256|103|S|doctor has judged that the benefit to you is greater than the||
0256|104|S|risk of side effects. Many people using this medication do not||
0256|105|S|have serious side effects.||
0256|106|S|   A very serious allergic reaction to this drug is rare.||
0256|107|S|However, get medical help right away if you notice any symptoms||
0256|108|S|of a serious allergic reaction, including: itching/swelling||
0256|109|S|(especially of the face/tongue/throat), rash, severe dizziness,||
0256|110|S|trouble breathing.||
0256|111|S|   This is not a complete list of possible side effects. If you||
0256|112|S|notice other effects not listed above, contact your doctor or||
0256|113|S|pharmacist.||
0256|114|S|   In the US -||
0256|115|S|   Call your doctor for medical advice about side effects. You||
0256|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0256|117|S|www.fda.gov/medwatch.||
0256|118|S|   In Canada - Call your doctor for medical advice about side||
0256|119|S|effects. You may report side effects to Health Canada at||
0256|120|S|1-866-234-2345.||
0256|121|B|||
0256|122|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0256|123|P|pharmacist if you are allergic to it; or if you have any other||
0256|124|P|allergies. This product may contain inactive ingredients (such as||
0256|125|P|cow's milk protein found in some products), which can cause||
0256|126|P|allergic reactions or other problems. Talk to your pharmacist for||
0256|127|P|more details.||
0256|128|P|   Before using this medication, tell your doctor your medical||
0256|129|P|history, especially of: bleeding problems, eye surgery, certain||
0256|130|P|eye problem (glaucoma), heart disease, diabetes, signs of||
0256|131|P|swelling/weakness/infection near the injection site, urinary||
0256|132|P|tract infection, inability to urinate, muscle/nerve disorders||
0256|133|P|(such as Lou Gehrig's disease-ALS, myasthenia gravis), seizures,||
0256|134|P|trouble swallowing (dysphagia), breathing problems (such as||
0256|135|P|asthma, emphysema, aspiration-type pneumonia), treatment with any||
0256|136|P|botulinum toxin product (especially in the last 4 months).||
0256|137|P|   This drug may make cause muscle weakness, droopy eyelids, or||
0256|138|P|blurred vision. Do not drive, use machinery, or do anything that||
0256|139|P|needs alertness or clear vision until you can do it safely. Limit||
0256|140|P|alcoholic beverages.||
0256|141|P|   Before having surgery, tell your doctor or dentist about all||
0256|142|P|the products you use (including prescription drugs,||
0256|143|P|nonprescription drugs, and herbal products).||
0256|144|P|   Some brands of this medication contain albumin made from human||
0256|145|P|blood. Even though the blood is carefully tested, and this||
0256|146|P|medication goes through a special manufacturing process, there is||
0256|147|P|an extremely small chance that you may get serious infections||
0256|148|P|from the medication. Consult your doctor or pharmacist for more||
0256|149|P|information.||
0256|150|P|   Older adults using this drug for overactive bladder may be||
0256|151|P|more sensitive to the side effects of this drug, especially||
0256|152|P|urinary effects.||
0256|153|P|   Children using this drug for muscle spasms may be more||
0256|154|P|sensitive to the side effects of this drug, including difficulty||
0256|155|P|breathing or swallowing. See also Warning section. Discuss the||
0256|156|P|risks and benefits with the doctor.||
0256|157|P|   This medication should be used only if clearly needed during||
0256|158|P|pregnancy. Discuss the risks and benefits with your doctor.||
0256|159|P|   It is unknown if this medication passes into breast milk.||
0256|160|P|Consult your doctor before breastfeeding.||
0256|161|B|||
0256|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0256|163|I|medications work or increase your risk for serious side effects.||
0256|164|I|This document does not contain all possible drug interactions.||
0256|165|I|Keep a list of all the products you use (including||
0256|166|I|prescription/nonprescription drugs and herbal products) and share||
0256|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
0256|168|I|the dosage of any medicines without your doctor's approval.||
0256|169|I|   Some products that may interact with this drug include:||
0256|170|I|certain antibiotics (including aminoglycosides such as||
0256|171|I|gentamicin, polymyxin), anticoagulants (such as warfarin),||
0256|172|I|Alzheimer's disease drugs (such as galantamine, rivastigmine,||
0256|173|I|tacrine), myasthenia gravis drugs (such as ambenonium,||
0256|174|I|pyridostigmine), quinidine.||
0256|175|B|||
0256|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0256|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0256|178|O|poison control center right away. US residents can call||
0256|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669. An||
0256|180|O|antitoxin is available but must be used before symptoms of||
0256|181|O|overdose become apparent. Symptoms of overdose may be delayed,||
0256|182|O|and may include serious muscle weakness, breathing problems and||
0256|183|O|paralysis.||
0256|184|B|||
0256|185|N|NOTES:  It is important to understand the risks and benefits of||
0256|186|N|this therapy. Discuss any questions or concerns with your health||
0256|187|N|care professional.||
0256|188|B|||
0256|189|D|MISSED DOSE:  Not applicable.||
0256|190|B|||
0256|191|R|STORAGE:  Not applicable. This medication is given in a hospital||
0256|192|R|or clinic and will not be stored at home.||
0256|193|B|||
0256|194|A|Information last revised April 2025.||
0256|195|A|Copyright(c) 2025 First Databank, Inc.||
0256|196|B|||
0257|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0257|002|Z|does NOT have all possible information about this product. This||
0257|003|Z|information does not assure that this product is safe, effective,||
0257|004|Z|or appropriate for you. This information is not individual||
0257|005|Z|medical advice and does not substitute for the advice of your||
0257|006|Z|health care professional. Always ask your health care||
0257|007|Z|professional for complete information about this product and your||
0257|008|Z|specific health needs.||
0257|009|B|||
0257|010|T|CAFFEINE - ORAL||
0257|011|F|(KAF-een)||
0257|012|B|||
0257|013|C|COMMON BRAND NAME(S): No Doz, Stay Awake, Vivarin||
0257|014|B|||
0257|015|U|USES:  This medication is used occasionally to help you stay||
0257|016|U|awake and alert when you are feeling tired and/or drowsy.||
0257|017|U|Caffeine is a mild stimulant.||
0257|018|U|   This medication should not be used to replace sleep.||
0257|019|U|   This medication should not be used by children younger than 12||
0257|020|U|years old.||
0257|021|B|||
0257|022|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
0257|023|H|directions on the product package, or take as directed by your||
0257|024|H|doctor. If you have any questions, ask your doctor or pharmacist.||
0257|025|H|   This medication should only be used as needed, not on a||
0257|026|H|regular basis. Though very unlikely, this medication may be||
0257|027|H|habit-forming. Do not increase your dose, take it more often than||
0257|028|H|directed, or take it regularly for a long time.||
0257|029|H|   Avoid drinking large amounts of beverages containing caffeine||
0257|030|H|(coffee, tea, colas) or eating large amounts of chocolate while||
0257|031|H|taking this medication.||
0257|032|H|   If you suddenly stop using this medication, you may have||
0257|033|H|withdrawal symptoms (such as headaches, mental/mood changes such||
0257|034|H|as irritation/nervousness). To help prevent withdrawal, your||
0257|035|H|doctor may lower your dose slowly. Withdrawal is more likely if||
0257|036|H|you have used caffeine for a long time or in high doses. Tell||
0257|037|H|your doctor or pharmacist right away if you have withdrawal.||
0257|038|H|   When used for an extended period, this medication may not work||
0257|039|H|as well. Talk with your doctor if this medication stops working||
0257|040|H|well.||
0257|041|H|   Tell your doctor if your condition lasts, gets worse, or||
0257|042|H|continues to occur again. If you think you may have a serious||
0257|043|H|medical problem, get medical help right away.||
0257|044|B|||
0257|045|S|SIDE EFFECTS:  Nausea, vomiting, stomach upset, trouble sleeping,||
0257|046|S|or increased urination may occur. If any of these effects last or||
0257|047|S|get worse, tell your doctor or pharmacist promptly.||
0257|048|S|   If your doctor has directed you to use this medication,||
0257|049|S|remember that your doctor has judged that the benefit to you is||
0257|050|S|greater than the risk of side effects. Many people using this||
0257|051|S|medication do not have serious side effects.||
0257|052|S|   Tell your doctor right away if you have any serious side||
0257|053|S|effects, including: dizziness, mental/mood changes (such as||
0257|054|S|nervousness, agitation), shaking (tremor), fast/irregular||
0257|055|S|heartbeat.||
0257|056|S|   A very serious allergic reaction to this drug is rare.||
0257|057|S|However, get medical help right away if you notice any symptoms||
0257|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0257|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0257|060|S|breathing.||
0257|061|S|   This is not a complete list of possible side effects. If you||
0257|062|S|notice other effects not listed above, contact your doctor or||
0257|063|S|pharmacist.||
0257|064|S|   In the US -||
0257|065|S|   Call your doctor for medical advice about side effects. You||
0257|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0257|067|S|www.fda.gov/medwatch.||
0257|068|S|   In Canada - Call your doctor for medical advice about side||
0257|069|S|effects. You may report side effects to Health Canada at||
0257|070|S|1-866-234-2345.||
0257|071|B|||
0257|072|P|PRECAUTIONS:  Before taking caffeine, tell your doctor or||
0257|073|P|pharmacist if you are allergic to it; or to other xanthine drugs||
0257|074|P|(such as theophylline); or if you have any other allergies. This||
0257|075|P|product may contain inactive ingredients, which can cause||
0257|076|P|allergic reactions or other problems. Talk to your pharmacist for||
0257|077|P|more details.||
0257|078|P|   Before using this medication, tell your doctor or pharmacist||
0257|079|P|your medical history, especially of: heart disease (such as||
0257|080|P|irregular heart rhythm, recent heart attack), high blood||
0257|081|P|pressure, stomach/intestinal ulcers, mental/mood disorders (such||
0257|082|P|as anxiety, nervousness).||
0257|083|P|   Before having surgery or certain medical procedures (such as a||
0257|084|P|heart stress test or a procedure to restore a normal heart rhythm||
0257|085|P|if you have an unusually fast heartbeat), tell your doctor or||
0257|086|P|dentist that you use this medication and about all the products||
0257|087|P|you use (including prescription drugs, nonprescription drugs, and||
0257|088|P|herbal products).||
0257|089|P|   Older adults may be more sensitive to the side effects of this||
0257|090|P|drug, especially trouble sleeping.||
0257|091|P|   During pregnancy, this medication should be used only when||
0257|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
0257|093|P|   This drug passes into breast milk. Consult your doctor before||
0257|094|P|breastfeeding.||
0257|095|B|||
0257|096|I|DRUG INTERACTIONS:  See also How to Use section.||
0257|097|I|   Drug interactions may change how your medications work or||
0257|098|I|increase your risk for serious side effects. This document does||
0257|099|I|not contain all possible drug interactions. Keep a list of all||
0257|100|I|the products you use (including prescription/nonprescription||
0257|101|I|drugs and herbal products) and share it with your doctor and||
0257|102|I|pharmacist. Do not start, stop, or change the dosage of any||
0257|103|I|medicines without your doctor's approval.||
0257|104|I|   Some products have ingredients that could raise your heart||
0257|105|I|rate or blood pressure. Tell your pharmacist what products you||
0257|106|I|are using, and ask how to use them safely (especially||
0257|107|I|cough-and-cold products, diet aids, or headache medications).||
0257|108|I|   This medication may interfere with certain medical/lab tests||
0257|109|I|(such as urine VMA/catecholamines levels, dipyridamole-thallium||
0257|110|I|imaging test), possibly causing false test results. Make sure lab||
0257|111|I|personnel and all your doctors know you use this drug.||
0257|112|B|||
0257|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0257|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0257|115|O|poison control center right away. US residents can call||
0257|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0257|117|O|Symptoms of overdose may include: stomach/abdominal pain,||
0257|118|O|mental/mood changes, seizures, fast/irregular heartbeat.||
0257|119|B|||
0257|120|N|NOTES:  Keep all medical and lab appointments.||
0257|121|B|||
0257|122|D|MISSED DOSE:  Not applicable.||
0257|123|B|||
0257|124|R|STORAGE:  Refer to storage information printed on the package.||
0257|125|R|Protect from light and moisture. Do not store in the bathroom. If||
0257|126|R|you have any questions about storage, ask your pharmacist. Keep||
0257|127|R|all medications away from children and pets.||
0257|128|R|   Do not flush medications down the toilet or pour them into a||
0257|129|R|drain unless instructed to do so. Properly discard this product||
0257|130|R|when it is expired or no longer needed. Consult your pharmacist||
0257|131|R|or local waste disposal company.||
0257|132|B|||
0257|133|A|Information last revised July 2025.||
0257|134|A|Copyright(c) 2025 First Databank, Inc.||
0257|135|B|||
0259|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0259|002|Z|does NOT have all possible information about this product. This||
0259|003|Z|information does not assure that this product is safe, effective,||
0259|004|Z|or appropriate for you. This information is not individual||
0259|005|Z|medical advice and does not substitute for the advice of your||
0259|006|Z|health care professional. Always ask your health care||
0259|007|Z|professional for complete information about this product and your||
0259|008|Z|specific health needs.||
0259|009|B|||
0259|010|T|HEMORRHOIDAL SUPPOSITORY - RECTAL||
0259|011|B|||
0259|012|U|USES:  This medication is used to temporarily relieve burning,||
0259|013|U|pain, and itching caused by hemorrhoids. This product contains||
0259|014|U|ingredients such as cocoa butter, starch, or zinc oxide that form||
0259|015|U|a protective barrier to prevent too much irritating contact with||
0259|016|U|stool. This barrier helps protect inflamed, irritated skin and||
0259|017|U|helps make bowel movements less painful.||
0259|018|U|   Do not use this product in children 12 years or younger||
0259|019|U|without talking with the doctor.||
0259|020|B|||
0259|021|H|HOW TO USE:  Follow all directions on the product package. If you||
0259|022|H|have any questions, ask your doctor or pharmacist.||
0259|023|H|   Use this product in the rectum, usually up to 6 times a day,||
0259|024|H|or after each bowel movement, or as directed by your doctor. The||
0259|025|H|dosage is based on your medical condition and response to||
0259|026|H|treatment. Do not use more often or for a longer time than||
0259|027|H|directed.||
0259|028|H|   Before use, clean the area with mild soap and water, rinse||
0259|029|H|well, and pat dry. If the suppository is too soft to insert,||
0259|030|H|place it in cold water or refrigerate it for 30 minutes before||
0259|031|H|removing the wrapper. To use suppositories, unwrap the||
0259|032|H|suppository. Lie on your left side with the right knee bent.||
0259|033|H|Carefully push the suppository (pointed side first) just inside||
0259|034|H|the anus with your finger. Do not push more than an inch or two||
0259|035|H|inside the anus.||
0259|036|H|   Do not use this medication if hemorrhoids are bleeding or the||
0259|037|H|rectal area is raw and irritated.||
0259|038|H|   Tell your doctor if your condition does not get better after 7||
0259|039|H|days or if bleeding/worsening pain occurs. If you think you may||
0259|040|H|have a serious medical problem, get medical help right away.||
0259|041|B|||
0259|042|S|SIDE EFFECTS:  This medication usually does not have side effects||
0259|043|S|when used as directed. If you have any unusual effects, contact||
0259|044|S|your doctor or pharmacist promptly.||
0259|045|S|   If your doctor has directed you to use this medication,||
0259|046|S|remember that your doctor has judged that the benefit to you is||
0259|047|S|greater than the risk of side effects. Many people using this||
0259|048|S|medication do not have serious side effects.||
0259|049|S|   A very serious allergic reaction to this drug is rare.||
0259|050|S|However, get medical help right away if you notice any symptoms||
0259|051|S|of a serious allergic reaction, including: rash, itching/swelling||
0259|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0259|053|S|breathing.||
0259|054|S|   This is not a complete list of possible side effects. If you||
0259|055|S|notice other effects not listed above, contact your doctor or||
0259|056|S|pharmacist.||
0259|057|S|   In the US -||
0259|058|S|   Call your doctor for medical advice about side effects. You||
0259|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0259|060|S|www.fda.gov/medwatch.||
0259|061|S|   In Canada - Call your doctor for medical advice about side||
0259|062|S|effects. You may report side effects to Health Canada at||
0259|063|S|1-866-234-2345.||
0259|064|B|||
0259|065|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0259|066|P|pharmacist if you are allergic to any of its ingredients, or if||
0259|067|P|you have any other allergies. This product may contain inactive||
0259|068|P|ingredients, which can cause allergic reactions or other||
0259|069|P|problems. Talk to your pharmacist for more details.||
0259|070|P|   Before using this medication, tell your doctor or pharmacist||
0259|071|P|your medical history.||
0259|072|P|   Before having surgery, tell your doctor or dentist about all||
0259|073|P|the products you use (including prescription drugs,||
0259|074|P|nonprescription drugs, and herbal products).||
0259|075|P|   During pregnancy, this medication should be used only when||
0259|076|P|clearly needed. Discuss the risks and benefits with your doctor.||
0259|077|P|   It is unknown if this medication passes into breast milk.||
0259|078|P|However, it is unlikely to pass into breast milk or to harm a||
0259|079|P|nursing infant. Consult your doctor before breastfeeding.||
0259|080|B|||
0259|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0259|082|I|medications work or increase your risk for serious side effects.||
0259|083|I|This document does not contain all possible drug interactions.||
0259|084|I|Keep a list of all the products you use (including||
0259|085|I|prescription/nonprescription drugs and herbal products) and share||
0259|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
0259|087|I|the dosage of any medicines without your doctor's approval.||
0259|088|B|||
0259|089|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0259|090|O|has overdosed and has serious symptoms such as passing out or||
0259|091|O|trouble breathing, call 911. Otherwise, call a poison control||
0259|092|O|center right away. US residents can call 1-800-222-1222. Canada||
0259|093|O|residents can call 1-844-764-7669.||
0259|094|B|||
0259|095|N|NOTES:  To maintain normal bowel function and reduce the risk of||
0259|096|N|hemorrhoids, eat a proper diet high in fiber, drink 6 to 8||
0259|097|N|glasses of water each day, and exercise regularly.||
0259|098|B|||
0259|099|D|MISSED DOSE:  If you are using this product on a regular schedule||
0259|100|D|and miss a dose, use it as soon as you remember. If it is near||
0259|101|D|the time of the next dose, skip the missed dose. Use your next||
0259|102|D|dose at the regular time. Do not double the dose to catch up.||
0259|103|B|||
0259|104|R|STORAGE:  Store at room temperature. Different brands of this||
0259|105|R|medication may have different storage needs. Check the product||
0259|106|R|package for instructions on how to store your brand, or ask your||
0259|107|R|pharmacist. Keep all medications away from children and pets.||
0259|108|R|   Do not flush medications down the toilet or pour them into a||
0259|109|R|drain unless instructed to do so. Properly discard this product||
0259|110|R|when it is expired or no longer needed. Consult your pharmacist||
0259|111|R|or local waste disposal company.||
0259|112|B|||
0259|113|A|Information last revised November 2024.||
0259|114|A|Copyright(c) 2025 First Databank, Inc.||
0259|115|B|||
0262|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0262|002|Z|does NOT have all possible information about this product. This||
0262|003|Z|information does not assure that this product is safe, effective,||
0262|004|Z|or appropriate for you. This information is not individual||
0262|005|Z|medical advice and does not substitute for the advice of your||
0262|006|Z|health care professional. Always ask your health care||
0262|007|Z|professional for complete information about this product and your||
0262|008|Z|specific health needs.||
0262|009|B|||
0262|010|T|MICONAZOLE TINCTURE - TOPICAL||
0262|011|F|(mye-KON-a-zole)||
0262|012|B|||
0262|013|C|COMMON BRAND NAME(S): Fungoid||
0262|014|B|||
0262|015|U|USES:  This medication is used to treat certain skin infections||
0262|016|U|caused by fungus (athlete's foot, ringworm, jock itch).||
0262|017|U|Miconazole reduces the red skin patches, itching, and peeling||
0262|018|U|that occur with these skin infections. It works by stopping the||
0262|019|U|growth of certain types of fungus. Miconazole belongs to a class||
0262|020|U|of drugs known as azole antifungals.||
0262|021|U|   This medication only treats certain fungal skin infections. It||
0262|022|U|will not work for other skin infections (such as those caused by||
0262|023|U|bacteria or viruses). Unnecessary use or overuse of any drug used||
0262|024|U|to treat infection can lead to its decreased effectiveness.||
0262|025|U|   This medication is not effective for treating fungal||
0262|026|U|infections of the scalp or nails. Do not use this product on||
0262|027|U|children under 2 years old unless directed by the doctor.||
0262|028|U|   If you are self-treating with this medication, it is important||
0262|029|U|to read the package instructions carefully before you start using||
0262|030|U|this product to be sure it is right for you. (See also||
0262|031|U|Precautions section.)||
0262|032|B|||
0262|033|H|HOW TO USE:  Use this medication only on the skin as directed by||
0262|034|H|your doctor. If you are self-treating, follow all directions on||
0262|035|H|the product package. If you have any questions, ask your doctor||
0262|036|H|or pharmacist.||
0262|037|H|   Before applying this medication, clean and completely dry the||
0262|038|H|affected areas. If this medication is used on children, parents||
0262|039|H|should apply it for them. Using the brush provided, apply a thin||
0262|040|H|layer of the medication as directed by your doctor, usually twice||
0262|041|H|daily (morning and evening). If you are treating athlete's foot,||
0262|042|H|also apply the medication in between the toes and on the skin||
0262|043|H|around/under the nails. Do not cover with a bandage or wrap the||
0262|044|H|area unless directed to do so by your doctor. Wash your hands||
0262|045|H|after each application.||
0262|046|H|   Avoid getting this medication in your eyes, nose, mouth,||
0262|047|H|vagina, or on healthy areas of skin. If this occurs, wipe off the||
0262|048|H|medication and rinse thoroughly with water. Call your doctor if||
0262|049|H|irritation occurs.||
0262|050|H|   Try not to spill this medication. If a spill occurs, wipe it||
0262|051|H|up right away. This medication can damage countertops, floors,||
0262|052|H|and other surfaces.||
0262|053|H|   Use this medication regularly to get the most benefit from it.||
0262|054|H|To help you remember, use it at the same times each day. Do not||
0262|055|H|apply large amounts of this medication, use it more often, or use||
0262|056|H|it for longer than directed. Your condition will not improve any||
0262|057|H|faster, and your risk of side effects may increase.||
0262|058|H|   Athlete's foot and ringworm usually require 4 weeks of||
0262|059|H|treatment with miconazole. Jock itch usually requires 2 weeks of||
0262|060|H|treatment. Continue to use this medication for the full time as||
0262|061|H|directed, even if symptoms disappear after a few days. Stopping||
0262|062|H|the medication too early may result in a return of the infection.||
0262|063|H|   Stop using this medication and get medical help right away if||
0262|064|H|your condition lasts after the above length of treatment, if it||
0262|065|H|gets worse, or if you think you may have a serious medical||
0262|066|H|problem.||
0262|067|B|||
0262|068|S|SIDE EFFECTS:  Skin irritation and burning may occur. If either||
0262|069|S|of these effects last or get worse, stop using this medication||
0262|070|S|and tell your doctor or pharmacist promptly.||
0262|071|S|   If your doctor has directed you to use this medication,||
0262|072|S|remember that your doctor has judged that the benefit to you is||
0262|073|S|greater than the risk of side effects. Many people using this||
0262|074|S|medication do not have serious side effects.||
0262|075|S|   A very serious allergic reaction to this drug is rare.||
0262|076|S|However, get medical help right away if you notice any symptoms||
0262|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0262|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0262|079|S|breathing.||
0262|080|S|   This is not a complete list of possible side effects. If you||
0262|081|S|notice other effects not listed above, contact your doctor or||
0262|082|S|pharmacist.||
0262|083|S|   In the US -||
0262|084|S|   Call your doctor for medical advice about side effects. You||
0262|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0262|086|S|www.fda.gov/medwatch.||
0262|087|S|   In Canada - Call your doctor for medical advice about side||
0262|088|S|effects. You may report side effects to Health Canada at||
0262|089|S|1-866-234-2345.||
0262|090|B|||
0262|091|P|PRECAUTIONS:  Before using miconazole, tell your doctor or||
0262|092|P|pharmacist if you are allergic to it; or to other azole||
0262|093|P|antifungals (such as clotrimazole, fluconazole, ketoconazole); or||
0262|094|P|if you have any other allergies. This product may contain||
0262|095|P|inactive ingredients (such as alcohol, glacial acetic acid),||
0262|096|P|which can cause allergic reactions or other problems. Talk to||
0262|097|P|your pharmacist for more details.||
0262|098|P|   Before using this medication, tell your doctor or pharmacist||
0262|099|P|your medical history, especially of: diabetes, blood circulation||
0262|100|P|problems, kidney problems, liver problems.||
0262|101|P|   Before having surgery, tell your doctor or dentist about all||
0262|102|P|the products you use (including prescription drugs,||
0262|103|P|nonprescription drugs, and herbal products).||
0262|104|P|   During pregnancy, this medication should be used only when||
0262|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
0262|106|P|   It is unknown if this drug passes into breast milk. Consult||
0262|107|P|your doctor before breastfeeding.||
0262|108|B|||
0262|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0262|110|I|medications work or increase your risk for serious side effects.||
0262|111|I|This document does not contain all possible drug interactions.||
0262|112|I|Keep a list of all the products you use (including||
0262|113|I|prescription/nonprescription drugs and herbal products) and share||
0262|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
0262|115|I|the dosage of any medicines without your doctor's approval.||
0262|116|B|||
0262|117|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0262|118|O|has overdosed and has serious symptoms such as passing out or||
0262|119|O|trouble breathing, call 911. Otherwise, call a poison control||
0262|120|O|center right away. US residents can call 1-800-222-1222. Canada||
0262|121|O|residents can call 1-844-764-7669.||
0262|122|B|||
0262|123|N|NOTES:  Keep all medical and lab appointments.||
0262|124|N|   If you are treating athlete's foot, dry thoroughly between the||
0262|125|N|toes after bathing, wear shoes that are breathable, and change||
0262|126|N|shoes and socks at least once daily.||
0262|127|N|   If you are treating jock itch, keep the groin area clean and||
0262|128|N|dry, avoid chafing, and wear clean cotton underwear.||
0262|129|B|||
0262|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0262|131|D|If it is near the time of the next dose, skip the missed dose.||
0262|132|D|Use your next dose at the regular time. Do not double the dose to||
0262|133|D|catch up.||
0262|134|B|||
0262|135|R|STORAGE:  Store at room temperature. Do not freeze. If freezing||
0262|136|R|occurs, place the medication container in warm water until it||
0262|137|R|reaches room temperature. This medication is flammable. Keep it||
0262|138|R|away from heat or open flame. Keep all medications away from||
0262|139|R|children and pets.||
0262|140|R|   Do not flush medications down the toilet or pour them into a||
0262|141|R|drain unless instructed to do so. Properly discard this product||
0262|142|R|when it is expired or no longer needed. Consult your pharmacist||
0262|143|R|or local waste disposal company.||
0262|144|B|||
0262|145|A|Information last revised July 2025.||
0262|146|A|Copyright(c) 2025 First Databank, Inc.||
0262|147|B|||
0265|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0265|002|Z|does NOT have all possible information about this product. This||
0265|003|Z|information does not assure that this product is safe, effective,||
0265|004|Z|or appropriate for you. This information is not individual||
0265|005|Z|medical advice and does not substitute for the advice of your||
0265|006|Z|health care professional. Always ask your health care||
0265|007|Z|professional for complete information about this product and your||
0265|008|Z|specific health needs.||
0265|009|B|||
0265|010|T|SIMETHICONE DROPS - ORAL||
0265|011|F|(sye-METH-i-kone)||
0265|012|B|||
0265|013|C|COMMON BRAND NAME(S): Mylicon||
0265|014|B|||
0265|015|U|USES:  This product is used to relieve symptoms of extra gas||
0265|016|U|caused by air swallowing or certain foods/infant formulas.||
0265|017|U|Simethicone helps break up gas bubbles in the gut.||
0265|018|U|   Check the ingredients on the label even if you have used the||
0265|019|U|product before. The manufacturer may have changed the||
0265|020|U|ingredients. Also, products with similar names may contain||
0265|021|U|different ingredients meant for different purposes. Giving the||
0265|022|U|wrong product could harm your child.||
0265|023|B|||
0265|024|H|HOW TO USE:  Follow all directions on the product package. If the||
0265|025|H|doctor has prescribed this medication, give it as directed. If||
0265|026|H|you have any questions, ask the doctor or pharmacist.||
0265|027|H|   Give this product by mouth, usually as needed after meals and||
0265|028|H|at bedtime. The dosage is based on your child's age, medical||
0265|029|H|condition, and response to treatment. Do not increase the dose or||
0265|030|H|give this product more often than directed. Do not give more of||
0265|031|H|this product than recommended for your child's age.||
0265|032|H|   Shake the container well before each use. Carefully measure||
0265|033|H|the dose using a special measuring device/dropper. Do not use a||
0265|034|H|household spoon because you may not get the correct dose. Use the||
0265|035|H|special measuring device/dropper to give the liquid by mouth. Try||
0265|036|H|to give it slowly, aiming for the side of the inside cheek to||
0265|037|H|prevent spitting or choking. The dosage may also be added to 1||
0265|038|H|ounce (30 milliliters) of cool water, infant formula, or juice.||
0265|039|H|Mix well and give the liquid right away. If you are using a||
0265|040|H|dropper to give this medication, rinse it well after each use.||
0265|041|H|   If your child's condition lasts or gets worse, or if you think||
0265|042|H|your child may have a serious medical problem, get medical help||
0265|043|H|right away.||
0265|044|B|||
0265|045|S|SIDE EFFECTS:  Simethicone usually has no side effects. If your||
0265|046|S|child has any unusual effects, contact the doctor or pharmacist||
0265|047|S|promptly.||
0265|048|S|   If the doctor has directed you to give this medication,||
0265|049|S|remember that the doctor has judged that the benefit to your||
0265|050|S|child is greater than the risk of side effects. Many people using||
0265|051|S|this medication do not have serious side effects.||
0265|052|S|   A very serious allergic reaction to this drug is rare.||
0265|053|S|However, get medical help right away if you notice any symptoms||
0265|054|S|of a serious allergic reaction, including: rash, itching/swelling||
0265|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0265|056|S|breathing.||
0265|057|S|   This is not a complete list of possible side effects. If you||
0265|058|S|notice other effects not listed above, contact the doctor or||
0265|059|S|pharmacist.||
0265|060|S|   In the US -||
0265|061|S|   Call the doctor for medical advice about side effects. You may||
0265|062|S|report side effects to FDA at 1-800-FDA-1088 or at||
0265|063|S|www.fda.gov/medwatch.||
0265|064|S|   In Canada - Call the doctor for medical advice about side||
0265|065|S|effects. You may report side effects to Health Canada at||
0265|066|S|1-866-234-2345.||
0265|067|B|||
0265|068|P|PRECAUTIONS:  Before giving simethicone, tell the doctor or||
0265|069|P|pharmacist if your child is allergic to it; or if your child has||
0265|070|P|any other allergies. This product may contain inactive||
0265|071|P|ingredients, which can cause allergic reactions or other||
0265|072|P|problems. Talk to the pharmacist for more details.||
0265|073|P|   If your child has any health problems, consult the doctor or||
0265|074|P|pharmacist before giving this product.||
0265|075|P|   Before having surgery, tell the doctor or dentist about all||
0265|076|P|the products your child is using (including prescription drugs,||
0265|077|P|nonprescription drugs, and herbal products).||
0265|078|P|   This form of simethicone is not usually used by adults. It is||
0265|079|P|unlikely to be used during pregnancy or breastfeeding. Consult||
0265|080|P|the doctor if you have any questions about this product.||
0265|081|B|||
0265|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0265|083|I|medications work or increase your risk for serious side effects.||
0265|084|I|This document does not contain all possible drug interactions.||
0265|085|I|Keep a list of all the products you use (including||
0265|086|I|prescription/nonprescription drugs and herbal products) and share||
0265|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
0265|088|I|the dosage of any medicines without your doctor's approval.||
0265|089|I|   Simethicone can decrease the absorption of thyroid medications||
0265|090|I|(such as levothyroxine). If your child takes thyroid medication,||
0265|091|I|give it at least 4 hours before or after products that contain||
0265|092|I|simethicone.||
0265|093|B|||
0265|094|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0265|095|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0265|096|O|poison control center right away. US residents can call||
0265|097|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0265|098|B|||
0265|099|N|NOTES:  Keep all medical and lab appointments.||
0265|100|B|||
0265|101|D|MISSED DOSE:  If your child is taking this product on a regular||
0265|102|D|schedule and misses a dose, give it as soon as you remember. If||
0265|103|D|it is near the time of the next dose, skip the missed dose. Give||
0265|104|D|the next dose at the regular time. Do not double the dose to||
0265|105|D|catch up.||
0265|106|B|||
0265|107|R|STORAGE:  Store at room temperature away from moisture, heat, and||
0265|108|R|light. Do not freeze. Do not store in the bathroom. Keep all||
0265|109|R|medications away from children and pets.||
0265|110|R|   Do not flush medications down the toilet or pour them into a||
0265|111|R|drain unless instructed to do so. Properly discard this product||
0265|112|R|when it is expired or no longer needed. Consult your pharmacist||
0265|113|R|or local waste disposal company.||
0265|114|B|||
0265|115|A|Information last revised May 2024.||
0265|116|A|Copyright(c) 2025 First Databank, Inc.||
0265|117|B|||
0266|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0266|002|Z|does NOT have all possible information about this product. This||
0266|003|Z|information does not assure that this product is safe, effective,||
0266|004|Z|or appropriate for you. This information is not individual||
0266|005|Z|medical advice and does not substitute for the advice of your||
0266|006|Z|health care professional. Always ask your health care||
0266|007|Z|professional for complete information about this product and your||
0266|008|Z|specific health needs.||
0266|009|B|||
0266|010|T|SUNSCREENS - TOPICAL||
0266|011|B|||
0266|012|U|USES:  Sunscreens are used to protect the skin from the harmful||
0266|013|U|effects of the sun. They help to prevent sunburn and premature||
0266|014|U|aging (such as wrinkles, leathery skin). Sunscreens also help to||
0266|015|U|decrease the risk of skin cancer and also of sunburn-like skin||
0266|016|U|reactions (sun sensitivity) caused by some medications (including||
0266|017|U|tetracyclines, sulfa drugs, phenothiazines such as||
0266|018|U|chlorpromazine).||
0266|019|U|   The active ingredients in sunscreens work either by absorbing||
0266|020|U|the sun's ultraviolet (UV) radiation, preventing it from reaching||
0266|021|U|the deeper layers of the skin, or by reflecting the radiation.||
0266|022|U|   Wearing sunscreen does not mean that you can stay out longer||
0266|023|U|in the sun. Sunscreens cannot protect against all of the sun's||
0266|024|U|radiation.||
0266|025|U|   There are various types of sunscreens available in many forms||
0266|026|U|(such as cream, lotion, gel, stick, spray, lip balm). See the||
0266|027|U|Notes section for information about selecting a sunscreen.||
0266|028|B|||
0266|029|H|HOW TO USE:  Sunscreens are for use on the skin only. Follow all||
0266|030|H|directions on the product package. If you have any questions, ask||
0266|031|H|your doctor or pharmacist.||
0266|032|H|   Apply sunscreen generously to all exposed skin 30 minutes||
0266|033|H|before sun exposure. As a general guide, use 1 ounce (30 grams)||
0266|034|H|to cover your entire body. Reapply the sunscreen after swimming||
0266|035|H|or sweating or drying off with a towel or if it has rubbed off.||
0266|036|H|If you are outside for long periods, reapply sunscreen every 2||
0266|037|H|hours. If you are using the lip balm form, apply to the lip area||
0266|038|H|only.||
0266|039|H|   The spray form is flammable until dry. If using the spray,||
0266|040|H|avoid smoking or being near open flames while using this||
0266|041|H|medication and until the medication has dried.||
0266|042|H|   When applying sunscreen to the face, be careful to avoid||
0266|043|H|contact with the eyes. If the sunscreen gets in your eyes, rinse||
0266|044|H|thoroughly with water.||
0266|045|H|   Use cautiously or avoid use on irritated skin.||
0266|046|H|   Do not use sunscreen on infants younger than 6 months unless||
0266|047|H|the doctor directs you to do so. It is best for infants to stay||
0266|048|H|out of the sun and wear protective clothing (such as hats, long||
0266|049|H|sleeves/pants) when outdoors.||
0266|050|H|   If you develop a serious sunburn, or if you think you may have||
0266|051|H|a serious medical problem, get medical help right away.||
0266|052|B|||
0266|053|S|SIDE EFFECTS:  Some sunscreen products (such as those containing||
0266|054|S|aminobenzoic acid or para-aminobenzoic acid/PABA) may stain||
0266|055|S|clothing.||
0266|056|S|   Some ingredients of sunscreens can cause the skin to become||
0266|057|S|more sensitive. If a sunscreen causes redness or irritation, wash||
0266|058|S|it off and stop using it. Talk to your doctor or pharmacist about||
0266|059|S|using another sunscreen product with different ingredients.||
0266|060|S|   If your doctor has directed you to use this medication,||
0266|061|S|remember that your doctor has judged that the benefit to you is||
0266|062|S|greater than the risk of side effects. Many people using this||
0266|063|S|medication do not have serious side effects.||
0266|064|S|   A very serious allergic reaction to this drug is rare.||
0266|065|S|However, get medical help right away if you notice any symptoms||
0266|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0266|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0266|068|S|breathing.||
0266|069|S|   This is not a complete list of possible side effects. If you||
0266|070|S|notice other effects not listed above, contact your doctor or||
0266|071|S|pharmacist.||
0266|072|S|   In the US -||
0266|073|S|   Call your doctor for medical advice about side effects. You||
0266|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0266|075|S|www.fda.gov/medwatch.||
0266|076|S|   In Canada - Call your doctor for medical advice about side||
0266|077|S|effects. You may report side effects to Health Canada at||
0266|078|S|1-866-234-2345.||
0266|079|B|||
0266|080|P|PRECAUTIONS:  Before using a sunscreen, tell your doctor or||
0266|081|P|pharmacist if you are allergic to any of its ingredients (such as||
0266|082|P|aminobenzoic acid/PABA); or to some types of anesthetic drugs||
0266|083|P|(such as benzocaine, tetracaine); or to sulfa drugs; or if you||
0266|084|P|have any other allergies. This product may contain inactive||
0266|085|P|ingredients, which can cause allergic reactions or other||
0266|086|P|problems. Talk to your pharmacist for more details.||
0266|087|B|||
0266|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0266|089|I|medications work or increase your risk for serious side effects.||
0266|090|I|This document does not contain all possible drug interactions.||
0266|091|I|Keep a list of all the products you use (including||
0266|092|I|prescription/nonprescription drugs and herbal products) and share||
0266|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
0266|094|I|the dosage of any medicines without your doctor's approval.||
0266|095|B|||
0266|096|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0266|097|O|has overdosed and has serious symptoms such as passing out or||
0266|098|O|trouble breathing, call 911. Otherwise, call a poison control||
0266|099|O|center right away. US residents can call 1-800-222-1222. Canada||
0266|100|O|residents can call 1-844-764-7669.||
0266|101|B|||
0266|102|N|NOTES:  The sun produces two types of ultraviolet (UV) radiation,||
0266|103|N|UVA and UVB. UVA radiation causes skin damage, premature aging,||
0266|104|N|and skin reactions to medications, soaps, cosmetics, and other||
0266|105|N|chemicals. UVB radiation causes sunburn. Both UVA and UVB||
0266|106|N|radiation increase your risk of skin cancer. Most sunscreens||
0266|107|N|protect against UVB radiation, but you should use a sunscreen||
0266|108|N|with both UVA and UVB protection (broad-spectrum coverage).||
0266|109|N|Products that protect against UVA include ingredients such as||
0266|110|N|avobenzone, octocrylene, titanium dioxide, zinc oxide, and||
0266|111|N|benzophenones such as oxybenzone. Ask your doctor or pharmacist||
0266|112|N|if you have questions about selecting a product.||
0266|113|N|   Sun Protection Factor (SPF) is a rating that tells how much||
0266|114|N|protection a product provides against sunburn. The higher the||
0266|115|N|number, the greater the protection. An SPF of at least 15 is||
0266|116|N|recommended. Products with SPF 30 provide high protection against||
0266|117|N|sunburn. The FDA states that products with SPF above 30 provide a||
0266|118|N|benefit that is not much greater than SPF 30 products.||
0266|119|N|   Water-resistant products provide protection for up to 40||
0266|120|N|minutes of water activity or sweating. Very water-resistant||
0266|121|N|products protect for up to 80 minutes. Reapply sunscreen as often||
0266|122|N|as necessary.||
0266|123|N|   Remember that water, sand, and snow reflect the sun. You||
0266|124|N|should protect yourself with sunscreen when in these||
0266|125|N|surroundings. Apply sunscreen even on cloudy days because the||
0266|126|N|sun's radiation is still present. In addition to sunscreen, wear||
0266|127|N|protective clothing (such as hat, long sleeves/pants, sunglasses)||
0266|128|N|when outdoors, and stay in the shade when possible. Avoid||
0266|129|N|prolonged sun exposure, especially between 10 AM to 4 PM when the||
0266|130|N|sun's radiation is strongest.||
0266|131|B|||
0266|132|D|MISSED DOSE:  Apply sunscreens generously and often when||
0266|133|D|outdoors.||
0266|134|B|||
0266|135|R|STORAGE:  Store at room temperature away from heat and light.||
0266|136|R|Refer to the storage information printed on the package. Do not||
0266|137|R|use a product after the expiration date on the container. If||
0266|138|R|there is no expiration date, it is recommended that you replace||
0266|139|R|sunscreens every year because over time they may lose the ability||
0266|140|R|to protect you from the sun. If you have any questions about||
0266|141|R|storage, ask your pharmacist. Keep all medications away from||
0266|142|R|children and pets.||
0266|143|R|   Do not flush medications down the toilet or pour them into a||
0266|144|R|drain unless instructed to do so. Properly discard this product||
0266|145|R|when it is expired or no longer needed. Consult your pharmacist||
0266|146|R|or local waste disposal company.||
0266|147|B|||
0266|148|A|Information last revised July 2025.||
0266|149|A|Copyright(c) 2025 First Databank, Inc.||
0266|150|B|||
0270|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0270|002|Z|does NOT have all possible information about this product. This||
0270|003|Z|information does not assure that this product is safe, effective,||
0270|004|Z|or appropriate for you. This information is not individual||
0270|005|Z|medical advice and does not substitute for the advice of your||
0270|006|Z|health care professional. Always ask your health care||
0270|007|Z|professional for complete information about this product and your||
0270|008|Z|specific health needs.||
0270|009|B|||
0270|010|T|RILUZOLE - ORAL||
0270|011|F|(RIL-ue-zole)||
0270|012|B|||
0270|013|C|COMMON BRAND NAME(S): Rilutek, Tiglutik||
0270|014|B|||
0270|015|U|USES:  This medication is used to treat a certain type of nerve||
0270|016|U|disease called amyotrophic lateral sclerosis (ALS, also commonly||
0270|017|U|called Lou Gehrig's disease). Riluzole helps to slow down the||
0270|018|U|worsening of this disease and prolong survival.||
0270|019|B|||
0270|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
0270|021|H|Instructions for Use if available from your pharmacist before you||
0270|022|H|start taking riluzole and each time you get a refill. If you have||
0270|023|H|any questions, ask your doctor or pharmacist.||
0270|024|H|   Take this medication by mouth on an empty stomach (at least 1||
0270|025|H|hour before or 2 hours after a meal) as directed by your doctor,||
0270|026|H|usually twice daily.||
0270|027|H|   If you are using the liquid form of this medication, gently||
0270|028|H|shake the bottle for at least 30 seconds before use. Carefully||
0270|029|H|measure the dose using a special measuring device/spoon. Do not||
0270|030|H|use a household spoon because you may not get the correct dose.||
0270|031|H|   Use this medication regularly to get the most benefit from it.||
0270|032|H|To help you remember, take it at the same times each day.||
0270|033|H|   Do not increase your dose or use this drug more often or for||
0270|034|H|longer than prescribed. Your condition will not improve any||
0270|035|H|faster, and your risk of side effects will increase.||
0270|036|H|   Tell your doctor if your condition gets worse.||
0270|037|B|||
0270|038|S|SIDE EFFECTS:  Dizziness, drowsiness, nausea, vomiting, or||
0270|039|S|numbness/tingling around the mouth may occur. If any of these||
0270|040|S|effects last or get worse, tell your doctor or pharmacist||
0270|041|S|promptly.||
0270|042|S|   Remember that this medication has been prescribed because your||
0270|043|S|doctor has judged that the benefit to you is greater than the||
0270|044|S|risk of side effects. Many people using this medication do not||
0270|045|S|have serious side effects.||
0270|046|S|   Tell your doctor right away if you have any serious side||
0270|047|S|effects, including: fast heartbeat, signs of pancreatitis or||
0270|048|S|liver disease (nausea/vomiting that doesn't stop, loss of||
0270|049|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0270|050|S|urine), signs of infection (such as sore throat that doesn't go||
0270|051|S|away, fever, chills), signs of lung problems (such as shortness||
0270|052|S|of breath, cough).||
0270|053|S|   A very serious allergic reaction to this drug is rare.||
0270|054|S|However, get medical help right away if you notice any symptoms||
0270|055|S|of a serious allergic reaction, including: rash, itching/swelling||
0270|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0270|057|S|breathing.||
0270|058|S|   This is not a complete list of possible side effects. If you||
0270|059|S|notice other effects not listed above, contact your doctor or||
0270|060|S|pharmacist.||
0270|061|S|   In the US -||
0270|062|S|   Call your doctor for medical advice about side effects. You||
0270|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0270|064|S|www.fda.gov/medwatch.||
0270|065|S|   In Canada - Call your doctor for medical advice about side||
0270|066|S|effects. You may report side effects to Health Canada at||
0270|067|S|1-866-234-2345.||
0270|068|B|||
0270|069|P|PRECAUTIONS:  Before taking riluzole, tell your doctor or||
0270|070|P|pharmacist if you are allergic to it; or if you have any other||
0270|071|P|allergies. This product may contain inactive ingredients, which||
0270|072|P|can cause allergic reactions or other problems. Talk to your||
0270|073|P|pharmacist for more details.||
0270|074|P|   Before using this medication, tell your doctor or pharmacist||
0270|075|P|your medical history, especially of: liver disease.||
0270|076|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0270|077|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0270|078|P|machinery, or do anything that needs alertness until you can do||
0270|079|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0270|080|P|are using marijuana (cannabis).||
0270|081|P|   Liquid products may contain sugar and/or aspartame. Caution is||
0270|082|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
0270|083|P|condition that requires you to limit/avoid these substances in||
0270|084|P|your diet. Ask your doctor or pharmacist about using this product||
0270|085|P|safely.||
0270|086|P|   Before having surgery, tell your doctor or dentist about all||
0270|087|P|the products you use (including prescription drugs,||
0270|088|P|nonprescription drugs, and herbal products).||
0270|089|P|   During pregnancy, this medication should be used only when||
0270|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
0270|091|P|   It is unknown if this drug passes into breast milk. Consult||
0270|092|P|your doctor before breastfeeding.||
0270|093|B|||
0270|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0270|095|I|medications work or increase your risk for serious side effects.||
0270|096|I|This document does not contain all possible drug interactions.||
0270|097|I|Keep a list of all the products you use (such as||
0270|098|I|prescription/nonprescription drugs and herbal products) and share||
0270|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
0270|100|I|the dosage of any medicines without your doctor's approval.||
0270|101|B|||
0270|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0270|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0270|104|O|poison control center right away. US residents can call||
0270|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0270|106|O|Symptoms of overdose may include: mental/mood changes (such as||
0270|107|O|confusion, memory loss), severe drowsiness.||
0270|108|B|||
0270|109|N|NOTES:  Do not share this medication with others.||
0270|110|N|   Lab and/or medical tests (such as liver function,||
0270|111|N|amylase/lipase levels) should be done before you start taking||
0270|112|N|this medication and while you are taking it. Keep all medical and||
0270|113|N|lab appointments. Consult your doctor for more details.||
0270|114|B|||
0270|115|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0270|116|D|remember. If it is near the time of the next dose, skip the||
0270|117|D|missed dose. Take your next dose at the regular time. Do not||
0270|118|D|double the dose to catch up.||
0270|119|B|||
0270|120|R|STORAGE:  Store at room temperature away from light and moisture.||
0270|121|R|Do not store in the bathroom. Store the liquid form upright and||
0270|122|R|do not freeze. Once the bottle for the liquid is opened, the||
0270|123|R|medication expires after 15 days. Keep all medications away from||
0270|124|R|children and pets.||
0270|125|R|   Do not flush medications down the toilet or pour them into a||
0270|126|R|drain unless instructed to do so. Properly discard this product||
0270|127|R|when it is expired or no longer needed. Consult your pharmacist||
0270|128|R|or local waste disposal company.||
0270|129|B|||
0270|130|A|Information last revised September 2025.||
0270|131|A|Copyright(c) 2025 First Databank, Inc.||
0270|132|B|||
0271|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0271|002|Z|does NOT have all possible information about this product. This||
0271|003|Z|information does not assure that this product is safe, effective,||
0271|004|Z|or appropriate for you. This information is not individual||
0271|005|Z|medical advice and does not substitute for the advice of your||
0271|006|Z|health care professional. Always ask your health care||
0271|007|Z|professional for complete information about this product and your||
0271|008|Z|specific health needs.||
0271|009|B|||
0271|010|T|DALTEPARIN - SUBCUTANEOUS INJECTION||
0271|011|F|(DAL-te-PAR-in)||
0271|012|B|||
0271|013|C|COMMON BRAND NAME(S): Fragmin||
0271|014|B|||
0271|015|W|WARNING:  People using this medication may bleed near the spinal||
0271|016|W|cord after certain spinal procedures. Bleeding in this area can||
0271|017|W|cause paralysis that lasts a long time or could become permanent.||
0271|018|W|Talk with your doctor about the benefits and risks before any||
0271|019|W|spinal procedure. Your doctor may direct you to stop this||
0271|020|W|medication for a certain amount of time before and after the||
0271|021|W|procedure. Carefully follow your doctor's directions.||
0271|022|W|   The risk of bleeding may be higher if you have a deformed||
0271|023|W|spine, or have had spinal procedures/surgery before (such as||
0271|024|W|epidural catheter placement, difficult epidural/spinal puncture),||
0271|025|W|or are taking other drugs that can cause bleeding/bruising||
0271|026|W|(including antiplatelet drugs such as clopidogrel, "blood||
0271|027|W|thinners" such as warfarin/rivaroxaban, nonsteroidal||
0271|028|W|anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your||
0271|029|W|doctor right away if you notice symptoms such as back pain, leg||
0271|030|W|numbness/tingling/weakness, loss of control of the bowels or||
0271|031|W|bladder (incontinence).||
0271|032|B|||
0271|033|U|USES:  Dalteparin is used to treat and prevent harmful blood||
0271|034|U|clots. Preventing harmful blood clots helps to reduce the risk of||
0271|035|U|a stroke or heart attack. This medication helps keep your blood||
0271|036|U|flowing smoothly by lowering the activity of clotting proteins in||
0271|037|U|the blood. Dalteparin is a type of heparin, and works as an||
0271|038|U|anticoagulant (commonly called a "blood thinner").||
0271|039|U|   Conditions that increase your risk of developing blood clots||
0271|040|U|include certain types of surgeries (such as hip replacement or||
0271|041|U|abdominal surgery), long periods of being in one position||
0271|042|U|(immobile), certain types of heart attack, and a certain type of||
0271|043|U|chest pain called unstable angina. For some medical conditions,||
0271|044|U|dalteparin may be used in combination with other "blood||
0271|045|U|thinners."||
0271|046|U|   Dalteparin may also be used to treat and prevent clots from||
0271|047|U|coming back in patients with cancer.||
0271|048|B|||
0271|049|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0271|050|H|from your pharmacist before you start using dalteparin and each||
0271|051|H|time you get a refill. If you have any questions, ask your doctor||
0271|052|H|or pharmacist.||
0271|053|H|   Inject this medication under the skin as directed by your||
0271|054|H|doctor, usually once or twice daily. The injection is given in||
0271|055|H|the abdomen or thighs. Do not inject into a muscle. The dosage||
0271|056|H|and length of treatment are based on your medical condition and||
0271|057|H|response to treatment. The dosage may also be based on your||
0271|058|H|weight for some conditions.||
0271|059|H|   If you are using this medication at home, learn all||
0271|060|H|preparation and usage instructions from your health care||
0271|061|H|professional and the product package. Before using, check this||
0271|062|H|product for particles or discoloration. If either is present, do||
0271|063|H|not use the liquid. This medication should not be mixed with or||
0271|064|H|added to any other medication in the same syringe. Before||
0271|065|H|injecting each dose, clean the skin you are going to inject into||
0271|066|H|(the injection site) with rubbing alcohol. Change the injection||
0271|067|H|site each time to lessen injury under the skin. To lessen||
0271|068|H|bruising, do not rub the injection site after a shot. Learn how||
0271|069|H|to store and discard medical supplies safely.||
0271|070|H|   To prevent blood clots due to surgery, your doctor may direct||
0271|071|H|you to start using this medication before or after surgery and||
0271|072|H|continue for several days. Follow your doctor's directions||
0271|073|H|closely.||
0271|074|H|   Use this medication regularly in order to get the most benefit||
0271|075|H|from it. To help you remember, use it at the same time(s) each||
0271|076|H|day.||
0271|077|B|||
0271|078|S|SIDE EFFECTS:  See also Warning section.||
0271|079|S|   Irritation, bruising, and pain at the injection site may||
0271|080|S|occur. If any of these effects last or get worse, tell your||
0271|081|S|doctor or pharmacist promptly.||
0271|082|S|   Remember that this medication has been prescribed because your||
0271|083|S|doctor has judged that the benefit to you is greater than the||
0271|084|S|risk of side effects. Many people using this medication do not||
0271|085|S|have serious side effects.||
0271|086|S|   This medication can cause bleeding if its effect on your blood||
0271|087|S|clotting proteins is too much. Tell your doctor right away if you||
0271|088|S|have any serious signs of bleeding, including: unusual||
0271|089|S|pain/swelling/discomfort, unusual or prolonged bleeding, unusual||
0271|090|S|or easy bruising, dark urine, black stools, severe headache,||
0271|091|S|confusion, vision changes, unusual dizziness, fainting, seizures,||
0271|092|S|weakness, numbness.||
0271|093|S|   A very serious allergic reaction to this drug is rare.||
0271|094|S|However, get medical help right away if you notice any symptoms||
0271|095|S|of a serious allergic reaction, including: rash, itching/swelling||
0271|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0271|097|S|breathing.||
0271|098|S|   This is not a complete list of possible side effects. If you||
0271|099|S|notice other effects not listed above, contact your doctor or||
0271|100|S|pharmacist.||
0271|101|S|   In the US -||
0271|102|S|   Call your doctor for medical advice about side effects. You||
0271|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0271|104|S|www.fda.gov/medwatch.||
0271|105|S|   In Canada - Call your doctor for medical advice about side||
0271|106|S|effects. You may report side effects to Health Canada at||
0271|107|S|1-866-234-2345.||
0271|108|B|||
0271|109|P|PRECAUTIONS:  Before using dalteparin, tell your doctor or||
0271|110|P|pharmacist if you are allergic to it; or to heparins or pork||
0271|111|P|products; or if you have any other allergies. This product may||
0271|112|P|contain inactive ingredients (such as latex found in the needle||
0271|113|P|shield), which can cause allergic reactions or other problems.||
0271|114|P|Talk to your pharmacist for more details.||
0271|115|P|   Before using this medication, tell your doctor or pharmacist||
0271|116|P|your medical history, especially of: serious active bleeding,||
0271|117|P|artificial heart valves, bleeding or blood disorders (low||
0271|118|P|platelet counts), certain eye problems (hypertensive or diabetic||
0271|119|P|retinopathy), high blood pressure, infection of the heart, kidney||
0271|120|P|disease, liver disease, low platelet counts after previous||
0271|121|P|heparin treatment, certain stomach/intestinal problems (such as||
0271|122|P|active or recent ulcers), stroke, recent spinal procedures or||
0271|123|P|puncture, spine problems (such as spinal deformity), recent||
0271|124|P|eye/brain/spinal cord surgery.||
0271|125|P|   Limit alcohol while taking this drug because it may increase||
0271|126|P|the risk of stomach bleeding.||
0271|127|P|   Before having surgery, tell your doctor or dentist about all||
0271|128|P|the products you use (including prescription drugs,||
0271|129|P|nonprescription drugs, and herbal products).||
0271|130|P|   To lower the chance of getting cut, bruised, or injured, use||
0271|131|P|caution with sharp objects like razors and nail cutters, and||
0271|132|P|avoid activities such as contact sports.||
0271|133|P|   Older adults may be more sensitive to the side effects of this||
0271|134|P|drug, especially bleeding.||
0271|135|P|   During pregnancy, this medication should be used only when||
0271|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
0271|137|P|   This medication passes into breast milk. Consult your doctor||
0271|138|P|before breastfeeding.||
0271|139|B|||
0271|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0271|141|I|medications work or increase your risk for serious side effects.||
0271|142|I|This document does not contain all possible drug interactions.||
0271|143|I|Keep a list of all the products you use (including||
0271|144|I|prescription/nonprescription drugs and herbal products) and share||
0271|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
0271|146|I|the dosage of any medicines without your doctor's approval.||
0271|147|I|   One product that may interact with this drug is: mifepristone.||
0271|148|I|   This medication is sometimes used together with other drugs||
0271|149|I|that have "blood thinning" or anti-platelet effects such as||
0271|150|I|aspirin, clopidogrel, or warfarin. When these combinations are||
0271|151|I|prescribed by your doctor, you will require closer monitoring to||
0271|152|I|minimize your risk of bleeding. Keep all medical and lab||
0271|153|I|appointments.||
0271|154|I|   Check all prescription and nonprescription medicine labels||
0271|155|I|carefully since many medications contain pain relievers/fever||
0271|156|I|reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) which||
0271|157|I|can increase the risk of bleeding/anti-platelet effect when used||
0271|158|I|with dalteparin. However, if your doctor has told you to take||
0271|159|I|low-dose aspirin to prevent heart attack or stroke (usually||
0271|160|I|81-162 milligrams a day), you should keep taking the aspirin||
0271|161|I|unless your doctor tells you not to. Ask your doctor or||
0271|162|I|pharmacist for more details.||
0271|163|B|||
0271|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0271|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0271|166|O|poison control center right away. US residents can call||
0271|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0271|168|O|Symptoms of overdose may include: excessive bleeding and||
0271|169|O|bruising.||
0271|170|B|||
0271|171|N|NOTES:  Do not share this medication with others.||
0271|172|N|   Lab and/or medical tests (such as complete blood count,||
0271|173|N|anti-factor Xa blood levels) should be done while you are using||
0271|174|N|this medication. Keep all medical and lab appointments. Consult||
0271|175|N|your doctor for more details.||
0271|176|B|||
0271|177|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0271|178|D|If it is near the time of the next dose, skip the missed dose.||
0271|179|D|Use your next dose at the regular time. Do not double the dose to||
0271|180|D|catch up.||
0271|181|B|||
0271|182|R|STORAGE:  Store at room temperature. Keep all medications away||
0271|183|R|from children and pets.||
0271|184|R|   Do not flush medications down the toilet or pour them into a||
0271|185|R|drain unless instructed to do so. Properly discard this product||
0271|186|R|when it is expired or no longer needed. Consult your pharmacist||
0271|187|R|or local waste disposal company.||
0271|188|B|||
0271|189|M|MEDICAL ALERT:  Your condition can cause complications in a||
0271|190|M|medical emergency. For information about enrolling in MedicAlert,||
0271|191|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0271|192|B|||
0271|193|A|Information last revised December 2024.||
0271|194|A|Copyright(c) 2025 First Databank, Inc.||
0271|195|B|||
0272|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0272|002|Z|does NOT have all possible information about this product. This||
0272|003|Z|information does not assure that this product is safe, effective,||
0272|004|Z|or appropriate for you. This information is not individual||
0272|005|Z|medical advice and does not substitute for the advice of your||
0272|006|Z|health care professional. Always ask your health care||
0272|007|Z|professional for complete information about this product and your||
0272|008|Z|specific health needs.||
0272|009|B|||
0272|010|T|DOXORUBICIN LIPOSOMAL - INJECTION||
0272|011|F|(DOX-oh-ROO-bi-sin LYE-poe-SOE-mal)||
0272|012|B|||
0272|013|C|COMMON BRAND NAME(S): Doxil||
0272|014|B|||
0272|015|W|WARNING:  Liposomal doxorubicin may cause heart problems,||
0272|016|W|including possibly fatal heart failure. Heart problems may occur||
0272|017|W|during liposomal doxorubicin therapy or months to years after||
0272|018|W|receiving this medication. Your risk of developing heart problems||
0272|019|W|depends on your dose, medical history (including previous heart||
0272|020|W|disease, radiation therapy in the chest area), and previous use||
0272|021|W|of this and other drugs (including daunorubicin and||
0272|022|W|cyclophosphamide). Children are at higher risk and should be||
0272|023|W|monitored later in life for delayed heart problems. See also Side||
0272|024|W|Effects section.||
0272|025|W|   While this drug is first being given into your vein, this||
0272|026|W|medication may cause severe (rarely fatal) reactions, including||
0272|027|W|allergic reactions. Tell your doctor right away if you experience||
0272|028|W|flushing, trouble breathing, swelling of the face, tightness in||
0272|029|W|the chest/throat, chills, back pain, severe dizziness, or fast||
0272|030|W|heartbeat. See also Side Effects section.||
0272|031|W|   Your doctor will closely monitor you while you are being||
0272|032|W|treated with this medication.||
0272|033|W|   Different types of this medication work in different ways. Do||
0272|034|W|not switch types of this medication without your doctor's||
0272|035|W|permission.||
0272|036|B|||
0272|037|U|USES:  Liposomal doxorubicin is an anthracycline-type||
0272|038|U|chemotherapy drug that is used to treat certain types of cancer||
0272|039|U|(such as ovarian cancer, AIDS-related Kaposi's sarcoma, multiple||
0272|040|U|myeloma). It works by slowing or stopping cancer cell growth.||
0272|041|B|||
0272|042|V|OTHER USES:  This section contains uses of this drug that are not||
0272|043|V|listed in the approved professional labeling for the drug but||
0272|044|V|that may be prescribed by your health care professional. Use this||
0272|045|V|drug for a condition that is listed in this section only if it||
0272|046|V|has been so prescribed by your health care professional.||
0272|047|V|   This drug may also be used for breast cancer.||
0272|048|B|||
0272|049|H|HOW TO USE:  This medication is given by injection into a vein||
0272|050|H|over 30-60 minutes or longer by a health care professional. The||
0272|051|H|dosage is based on your medical condition, body size, and||
0272|052|H|response to treatment. Notify your doctor right away if redness,||
0272|053|H|pain, or swelling occur at or near the injection site.||
0272|054|H|   If this medication touches your skin, immediately and||
0272|055|H|completely wash skin with soap and water. If this medication gets||
0272|056|H|in your eye, open the eyelids and flush with plenty of water for||
0272|057|H|15 minutes. Get medical help right away.||
0272|058|H|   Family members and caregivers should take precautions (such as||
0272|059|H|wear gloves) to prevent contact with the patient's urine or other||
0272|060|H|body fluid for at least 5 days after treatment. Consult your||
0272|061|H|pharmacist.||
0272|062|B|||
0272|063|S|SIDE EFFECTS:  See also Warning section.||
0272|064|S|   Body aches/pains, headache, nausea, vomiting, constipation,||
0272|065|S|diarrhea, stomach upset, and loss of appetite may occur. Nausea||
0272|066|S|and vomiting can be severe. In some cases, drug therapy may be||
0272|067|S|needed to prevent or relieve nausea and vomiting. Not eating||
0272|068|S|before your treatment may help relieve vomiting. Changes in diet||
0272|069|S|and lifestyle, such as eating several small meals and limiting||
0272|070|S|activity, may help lessen some of these effects. If any of these||
0272|071|S|effects last or get worse, tell your doctor or pharmacist||
0272|072|S|promptly.||
0272|073|S|   This medication may give a reddish-orange color to your urine,||
0272|074|S|tears, and sweat. This is a normal effect of the drug and should||
0272|075|S|not be mistaken for blood in your urine.||
0272|076|S|   Temporary hair loss may occur. Normal hair growth should||
0272|077|S|return several months after treatment has ended.||
0272|078|S|   Remember that this medication has been prescribed because your||
0272|079|S|doctor has judged that the benefit to you is greater than the||
0272|080|S|risk of side effects. Many people using this medication do not||
0272|081|S|have serious side effects.||
0272|082|S|   Treatment with this drug may sometimes cause your hands/feet||
0272|083|S|to develop a skin reaction called hand-foot syndrome||
0272|084|S|(palmar-plantar erythrodysesthesia). Notify your doctor promptly||
0272|085|S|if you experience swelling, pain, redness, dryness, peeling,||
0272|086|S|blisters, or tingling/burning of the hands/feet. The symptoms can||
0272|087|S|be made worse by heat/pressure on your hands/feet. Avoid||
0272|088|S|prolonged sun exposure, tanning booths, and sunlamps, as well as||
0272|089|S|unnecessary exposure to heat (such as hot dishwater, long hot||
0272|090|S|baths). Avoid pressure on elbows, knees, and soles of feet (such||
0272|091|S|as leaning on elbows, kneeling, long walks). Wear loose clothing.||
0272|092|S|Depending on how severe your hand-foot syndrome is, your doctor||
0272|093|S|may give you something to reduce the symptoms, or decrease or||
0272|094|S|delay your next dose of liposomal doxorubicin.||
0272|095|S|   Tell your doctor right away if you have any serious side||
0272|096|S|effects, including: symptoms of heart failure (such as shortness||
0272|097|S|of breath, swelling ankles/feet, unusual tiredness,||
0272|098|S|unusual/sudden weight gain), drowsiness, trouble sleeping,||
0272|099|S|mental/mood changes (such as anxiety, confusion, depression),||
0272|100|S|cough/hoarseness, redness/pain/swelling of arms/legs, eye||
0272|101|S|redness/itching, painful/difficult urination, stomach/abdominal||
0272|102|S|pain, yellowing of the skin/eyes, dark urine, black/tarry stools,||
0272|103|S|bloody mucus or discharge in stools, vision changes (such as||
0272|104|S|blindness), fast/irregular heartbeat.||
0272|105|S|   This medication may cause certain severe (rarely fatal) blood||
0272|106|S|disorders (bone marrow suppression leading to low red blood||
0272|107|S|cells/white blood cells /platelets). This can lower your body's||
0272|108|S|ability to fight infection and stop bleeding. Tell your doctor||
0272|109|S|right away if you develop any signs of infection (such as sore||
0272|110|S|throat that doesn't go away, fever, chills), unusual tiredness,||
0272|111|S|or easy bleeding/bruising.||
0272|112|S|   Painful swelling or sores on the lips, mouth and throat may||
0272|113|S|occur. To decrease the risk, limit hot foods and drinks, brush||
0272|114|S|your teeth carefully, avoid using mouthwash that contains||
0272|115|S|alcohol, and rinse your mouth often with cool water.||
0272|116|S|   Get medical help right away if you have any very serious side||
0272|117|S|effects, including: chest pain.||
0272|118|S|   Within days to weeks after doxorubicin treatment, a serious||
0272|119|S|skin reaction that looks likes a severe sunburn (radiation||
0272|120|S|recall) may develop on any area of skin that has been previously||
0272|121|S|treated with radiation. Tell your doctor right away if you||
0272|122|S|develop skin redness, pain, tenderness, swelling, peeling, or||
0272|123|S|blisters. Your doctor may prescribe medication to help your skin||
0272|124|S|heal faster and reduce the swelling. Sunlight may worsen any skin||
0272|125|S|reactions that may occur while you are using this drug. Avoid||
0272|126|S|prolonged sun exposure, tanning booths and sunlamps. Use a||
0272|127|S|sunscreen and wear protective clothing when outdoors.||
0272|128|S|   In children, radiation recall may occur in the lungs. Tell the||
0272|129|S|doctor right away if you notice wheezing or trouble breathing in||
0272|130|S|the child.||
0272|131|S|   Very rarely, people with cancer who are treated with this type||
0272|132|S|of medication have developed other cancers (such as secondary||
0272|133|S|leukemia, oral cancer). Your risk is greater if you have received||
0272|134|S|this medication long-term (more than 1 year), or with certain||
0272|135|S|types of chemotherapy or radiation treatment. Consult your doctor||
0272|136|S|for more details.||
0272|137|S|   A very serious allergic reaction to this drug is rare.||
0272|138|S|However, get medical help right away if you notice any symptoms||
0272|139|S|of a serious allergic reaction, including: rash, itching/swelling||
0272|140|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0272|141|S|breathing.||
0272|142|S|   This is not a complete list of possible side effects. If you||
0272|143|S|notice other effects not listed above, contact your doctor or||
0272|144|S|pharmacist.||
0272|145|S|   In the US -||
0272|146|S|   Call your doctor for medical advice about side effects. You||
0272|147|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0272|148|S|www.fda.gov/medwatch.||
0272|149|S|   In Canada - Call your doctor for medical advice about side||
0272|150|S|effects. You may report side effects to Health Canada at||
0272|151|S|1-866-234-2345.||
0272|152|B|||
0272|153|P|PRECAUTIONS:  Before using liposomal doxorubicin, tell your||
0272|154|P|doctor or pharmacist if you are allergic to it; or to||
0272|155|P|doxorubicin; or to other drugs containing polyethylene glycol; or||
0272|156|P|to lincomycin; or if you have any other allergies. This product||
0272|157|P|may contain inactive ingredients, which can cause allergic||
0272|158|P|reactions or other problems. Talk to your pharmacist for more||
0272|159|P|details.||
0272|160|P|   Before using this medication, tell your doctor or pharmacist||
0272|161|P|your medical history, especially of: low blood cell counts (such||
0272|162|P|as anemia, neutropenia, thrombocytopenia), gout, heart problems,||
0272|163|P|a history of receiving any anthracycline-type drug (such as||
0272|164|P|doxorubicin, idarubicin, daunorubicin, mitoxantrone), infection,||
0272|165|P|liver problems, radiation treatment (especially to the chest||
0272|166|P|area), kidney problems.||
0272|167|P|   Liposomal doxorubicin can make you more likely to get||
0272|168|P|infections or may make current infections worse. Stay away from||
0272|169|P|anyone who has an infection that may easily spread (such as||
0272|170|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
0272|171|P|have been exposed to an infection or for more details.||
0272|172|P|   Tell your health care professional that you are using||
0272|173|P|liposomal doxorubicin before having any||
0272|174|P|immunizations/vaccinations. Avoid contact with people who have||
0272|175|P|recently received live vaccines (such as flu vaccine inhaled||
0272|176|P|through the nose).||
0272|177|P|   To lower the chance of getting cut, bruised or injured, use||
0272|178|P|caution with sharp objects like safety razors and nail cutters,||
0272|179|P|and avoid activities such as contact sports. Use a soft-bristle||
0272|180|P|toothbrush to lower the risk of bleeding gums.||
0272|181|P|   Children may be more sensitive to the side effects of this||
0272|182|P|drug, especially effects on the heart.||
0272|183|P|   Tell your doctor if you are pregnant or plan to become||
0272|184|P|pregnant. You should not become pregnant while using liposomal||
0272|185|P|doxorubicin. Liposomal doxorubicin may harm an unborn baby. Your||
0272|186|P|doctor should order a pregnancy test before you start this||
0272|187|P|medication. Women using this medication should ask about reliable||
0272|188|P|forms of birth control during treatment and for some time after||
0272|189|P|the last dose. Men using this medication should ask about||
0272|190|P|reliable forms of birth control during treatment and for 6 months||
0272|191|P|after the last dose. If you or your partner becomes pregnant,||
0272|192|P|talk to your doctor right away about the risks and benefits of||
0272|193|P|this medication.||
0272|194|P|   This medication passes into breast milk. Because of the||
0272|195|P|possible risk to the infant, breastfeeding is not recommended||
0272|196|P|while using this medication. Consult your doctor before||
0272|197|P|breastfeeding.||
0272|198|B|||
0272|199|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0272|200|I|medications work or increase your risk for serious side effects.||
0272|201|I|This document does not contain all possible drug interactions.||
0272|202|I|Keep a list of all the products you use (including||
0272|203|I|prescription/nonprescription drugs and herbal products) and share||
0272|204|I|it with your doctor and pharmacist. Do not start, stop, or change||
0272|205|I|the dosage of any medicines without your doctor's approval.||
0272|206|I|   Some products that may interact with this drug include:||
0272|207|I|digoxin, progesterone, streptozocin, stavudine, trastuzumab,||
0272|208|I|zidovudine.||
0272|209|I|   Other medications can affect the removal of doxorubicin from||
0272|210|I|your body, which may affect how doxorubicin works. Examples||
0272|211|I|include azole antifungals (such as ketoconazole), calcium channel||
0272|212|I|blockers (such as verapamil, nifedipine), rifamycins (such as||
0272|213|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
0272|214|I|as carbamazepine, phenytoin, phenobarbital, primidone), among||
0272|215|I|others.||
0272|216|I|   Avoid eating foods or products containing turmeric (curcumin)||
0272|217|I|while being treated with liposomal doxorubicin. It may decrease||
0272|218|I|this medication's effects. Consult your doctor or pharmacist for||
0272|219|I|more details.||
0272|220|B|||
0272|221|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0272|222|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0272|223|O|poison control center right away. US residents can call||
0272|224|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0272|225|O|Symptoms of overdose may include: unexplained bleeding.||
0272|226|B|||
0272|227|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
0272|228|N|heart studies, liver function) should be done while you are using||
0272|229|N|this medication. Keep all medical and lab appointments. Consult||
0272|230|N|your doctor for more details.||
0272|231|B|||
0272|232|D|MISSED DOSE:  It is important to get each dose of this medication||
0272|233|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0272|234|D|right away for a new dosing schedule.||
0272|235|B|||
0272|236|R|STORAGE:  Consult the product instructions and your pharmacist||
0272|237|R|for storage details. Keep all medications away from children and||
0272|238|R|pets.||
0272|239|R|   Do not flush medications down the toilet or pour them into a||
0272|240|R|drain unless instructed to do so. Properly discard this product||
0272|241|R|when it is expired or no longer needed. Consult your pharmacist||
0272|242|R|or local waste disposal company.||
0272|243|B|||
0272|244|M|MEDICAL ALERT:  Your condition can cause complications in a||
0272|245|M|medical emergency. For information about enrolling in MedicAlert,||
0272|246|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0272|247|B|||
0272|248|A|Information last revised June 2024.||
0272|249|A|Copyright(c) 2025 First Databank, Inc.||
0272|250|B|||
0273|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0273|002|Z|does NOT have all possible information about this product. This||
0273|003|Z|information does not assure that this product is safe, effective,||
0273|004|Z|or appropriate for you. This information is not individual||
0273|005|Z|medical advice and does not substitute for the advice of your||
0273|006|Z|health care professional. Always ask your health care||
0273|007|Z|professional for complete information about this product and your||
0273|008|Z|specific health needs.||
0273|009|B|||
0273|010|T|TRETINOIN - ORAL||
0273|011|F|(TRET-i-noyn)||
0273|012|B|||
0273|013|C|COMMON BRAND NAME(S): Vesanoid||
0273|014|B|||
0273|015|W|WARNING:  Tretinoin may cause serious (sometimes fatal) side||
0273|016|W|effects, usually within the first month of treatment with this||
0273|017|W|medication. Careful monitoring by your doctor may decrease your||
0273|018|W|risk. Tell your doctor right away if you have symptoms such as||
0273|019|W|fever, trouble breathing, unusual tiredness, weight gain,||
0273|020|W|swelling of the arms/legs/ankles/feet, dizziness, or fainting.||
0273|021|W|Your doctor may temporarily stop your treatment if you get||
0273|022|W|serious side effects.||
0273|023|W|   This drug may cause serious (possibly fatal) harm to an unborn||
0273|024|W|baby if used during pregnancy. You must have a negative pregnancy||
0273|025|W|test before starting treatment and monthly pregnancy tests may||
0273|026|W|also be done while you are taking this medication. Women using||
0273|027|W|this medication should discuss the use of at least 2 reliable||
0273|028|W|forms of birth control (such as condoms, birth control pills)||
0273|029|W|during treatment and for 1 month after the last dose. Men using||
0273|030|W|this medication should ask about reliable forms of birth control||
0273|031|W|during treatment and for 1 week after the last dose. Consult your||
0273|032|W|doctor for more details. If you are planning pregnancy, become||
0273|033|W|pregnant, or think you may be pregnant, tell your doctor right||
0273|034|W|away. (See also Precautions section).||
0273|035|B|||
0273|036|U|USES:  Tretinoin is used to treat a certain type of cancer||
0273|037|U|(APL-acute promyelocytic leukemia). People with APL have too many||
0273|038|U|abnormal blood cells which may cause symptoms such as infections||
0273|039|U|or tiredness. This medication works by stopping the growth of||
0273|040|U|abnormal blood cells and may help decrease symptoms of APL.||
0273|041|U|Tretinoin belongs to a class of drugs known as retinoids, which||
0273|042|U|are related to vitamin A.||
0273|043|B|||
0273|044|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0273|045|H|from your pharmacist before you start taking tretinoin and each||
0273|046|H|time you get a refill. If you have any questions, ask your doctor||
0273|047|H|or pharmacist.||
0273|048|H|   Take this medication by mouth with food as directed by your||
0273|049|H|doctor, usually twice daily. Swallow the capsules whole with||
0273|050|H|water. Do not chew, dissolve, or open the capsule. If you vomit,||
0273|051|H|do not take another dose to catch up. Take your next dose at the||
0273|052|H|regular time.||
0273|053|H|   The dosage is based on your medical condition, body size, and||
0273|054|H|response to treatment.||
0273|055|H|   Use this medication regularly to get the most benefit from it.||
0273|056|H|To help you remember, take it at the same times each day.||
0273|057|H|   Do not increase your dose or use this drug more often or for||
0273|058|H|longer than prescribed. Your condition will not improve any||
0273|059|H|faster, and your risk of serious side effects will increase.||
0273|060|H|   Since this drug can be absorbed through the skin and lungs and||
0273|061|H|may harm an unborn baby, women who are pregnant or who may become||
0273|062|H|pregnant should not handle this medication or breathe the dust||
0273|063|H|from the capsules.||
0273|064|B|||
0273|065|S|SIDE EFFECTS:  See also Warning section.||
0273|066|S|   Headache, dizziness, fever, weakness, tiredness, dry mouth,||
0273|067|S|dry skin, other skin changes, thinning hair, nausea, vomiting,||
0273|068|S|itching, bone pain, mouth sores, increased sweating, and earache||
0273|069|S|may occur. If any of these effects last or get worse, notify your||
0273|070|S|doctor or pharmacist promptly.||
0273|071|S|   Headache may occur several hours after taking a dose. Mild||
0273|072|S|pain medications (such as acetaminophen) usually help relieve||
0273|073|S|these headaches, which tend to go away as your body gets used to||
0273|074|S|tretinoin. Talk with your doctor about which pain relievers are||
0273|075|S|right for you.||
0273|076|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0273|077|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0273|078|S|substitute.||
0273|079|S|   Remember that this medication has been prescribed because your||
0273|080|S|doctor has judged that the benefit to you is greater than the||
0273|081|S|risk of side effects. Many people using this medication do not||
0273|082|S|have serious side effects.||
0273|083|S|   Tell your doctor right away if you have any serious side||
0273|084|S|effects, including: stomach/abdominal pain, yellowing eyes/skin,||
0273|085|S|dark urine, hearing problems (such as hearing loss), signs of||
0273|086|S|kidney problems (such as change in the amount of urine),||
0273|087|S|mental/mood changes (such as depression, anxiety, thoughts of||
0273|088|S|suicide), fast/slow/irregular heartbeat.||
0273|089|S|   Get medical help right away if you have any very serious side||
0273|090|S|effects, including: nausea/vomiting that doesn't stop, severe||
0273|091|S|headache, vision changes, chest pain, jaw/left arm pain, trouble||
0273|092|S|breathing, weakness on one side of the body, trouble speaking,||
0273|093|S|confusion, pain/redness/swelling of arms/legs.||
0273|094|S|   A very serious allergic reaction to this drug is rare.||
0273|095|S|However, get medical help right away if you notice any symptoms||
0273|096|S|of a serious allergic reaction, including: rash, itching/swelling||
0273|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0273|098|S|breathing.||
0273|099|S|   This is not a complete list of possible side effects. If you||
0273|100|S|notice other effects not listed above, contact your doctor or||
0273|101|S|pharmacist.||
0273|102|S|   In the US -||
0273|103|S|   Call your doctor for medical advice about side effects. You||
0273|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0273|105|S|www.fda.gov/medwatch.||
0273|106|S|   In Canada - Call your doctor for medical advice about side||
0273|107|S|effects. You may report side effects to Health Canada at||
0273|108|S|1-866-234-2345.||
0273|109|B|||
0273|110|P|PRECAUTIONS:  Before taking tretinoin, tell your doctor or||
0273|111|P|pharmacist if you are allergic to it; or to vitamin A-related||
0273|112|P|drugs (other retinoids such as isotretinoin); or if you have any||
0273|113|P|other allergies. This product may contain inactive ingredients||
0273|114|P|(such as soybean, paraben preservatives), which can cause||
0273|115|P|allergic reactions or other problems. Some people who are||
0273|116|P|allergic to peanuts may also be allergic to soy. Talk to your||
0273|117|P|pharmacist for more details.||
0273|118|P|   Before using this medication, tell your doctor or pharmacist||
0273|119|P|your medical history, especially of: liver disease, heart||
0273|120|P|problems, mental/mood problems (such as depression).||
0273|121|P|   This drug may make you dizzy or cause severe headaches or||
0273|122|P|vision changes. Alcohol or marijuana (cannabis) can make you more||
0273|123|P|dizzy. Do not drive, use machinery, or do anything that needs||
0273|124|P|alertness or clear vision until you can do it safely. Limit||
0273|125|P|alcoholic beverages. Talk to your doctor if you are using||
0273|126|P|marijuana (cannabis).||
0273|127|P|   Children may be at greater risk for increased pressure in the||
0273|128|P|brain (intracranial hypertension) while using this drug. Get||
0273|129|P|medical help right away if your child has symptoms such as severe||
0273|130|P|headache, nausea/vomiting that doesn't stop, or vision changes.||
0273|131|P|   Do not donate blood while you are taking this medication and||
0273|132|P|for at least 1 month after you stop taking it. This will prevent||
0273|133|P|the possibility of your blood being given to a pregnant woman.||
0273|134|P|   This medication must not be used during pregnancy. It may harm||
0273|135|P|an unborn baby. If you become pregnant or think you may be||
0273|136|P|pregnant, tell your doctor right away. (See also Warning||
0273|137|P|section.)||
0273|138|P|   Since this drug can be absorbed through the skin and lungs and||
0273|139|P|may harm an unborn baby, women who are pregnant or who may become||
0273|140|P|pregnant should not handle this medication or breathe the dust||
0273|141|P|from the capsules.||
0273|142|P|   It is unknown if this drug passes into breast milk. Because of||
0273|143|P|the possible risk to the infant, breastfeeding is not recommended||
0273|144|P|while using this drug and for 1 week after the last dose. Consult||
0273|145|P|your doctor before breastfeeding.||
0273|146|B|||
0273|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0273|148|I|medications work or increase your risk for serious side effects.||
0273|149|I|This document does not contain all possible drug interactions.||
0273|150|I|Keep a list of all the products you use (including||
0273|151|I|prescription/nonprescription drugs and herbal products) and share||
0273|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
0273|153|I|the dosage of any medicines without your doctor's approval.||
0273|154|I|   Some products that may interact with this drug include:||
0273|155|I|certain drugs that prevent bleeding (such as aminocaproic acid,||
0273|156|I|aprotinin, tranexamic acid), tetracycline antibiotics (such as||
0273|157|I|doxycycline, minocycline), vitamin A.||
0273|158|B|||
0273|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0273|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0273|161|O|poison control center right away. US residents can call||
0273|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0273|163|B|||
0273|164|N|NOTES:  Do not share this medication with others.||
0273|165|N|   Lab and/or medical tests (such as complete blood counts, liver||
0273|166|N|function, blood cholesterol and triglyceride levels) should be||
0273|167|N|done while you are taking this medication. Keep all medical and||
0273|168|N|lab appointments. Consult your doctor for more details.||
0273|169|B|||
0273|170|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0273|171|D|remember. If it is less than 10 hours before the next dose, skip||
0273|172|D|the missed dose. Take your next dose at the regular time. Do not||
0273|173|D|double the dose to catch up.||
0273|174|B|||
0273|175|R|STORAGE:  Store at room temperature away from light and moisture.||
0273|176|R|Do not store in the bathroom. Keep all medications away from||
0273|177|R|children and pets.||
0273|178|R|   Do not flush medications down the toilet or pour them into a||
0273|179|R|drain unless instructed to do so. Properly discard this product||
0273|180|R|when it is expired or no longer needed. Consult your pharmacist||
0273|181|R|or local waste disposal company.||
0273|182|B|||
0273|183|A|Information last revised June 2024.||
0273|184|A|Copyright(c) 2025 First Databank, Inc.||
0273|185|B|||
0276|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0276|002|Z|does NOT have all possible information about this product. This||
0276|003|Z|information does not assure that this product is safe, effective,||
0276|004|Z|or appropriate for you. This information is not individual||
0276|005|Z|medical advice and does not substitute for the advice of your||
0276|006|Z|health care professional. Always ask your health care||
0276|007|Z|professional for complete information about this product and your||
0276|008|Z|specific health needs.||
0276|009|B|||
0276|010|T|DILTIAZEM TABLET - ORAL||
0276|011|F|(dil-TYE-a-zem)||
0276|012|B|||
0276|013|C|COMMON BRAND NAME(S): Cardizem||
0276|014|B|||
0276|015|U|USES:  Diltiazem is used to prevent chest pain (angina). It may||
0276|016|U|help to increase your ability to exercise and decrease how often||
0276|017|U|you may get angina attacks. Diltiazem is called a calcium channel||
0276|018|U|blocker. It works by relaxing blood vessels in the body and heart||
0276|019|U|and lowers the heart rate. Blood can flow more easily and your||
0276|020|U|heart works less hard to pump blood.||
0276|021|B|||
0276|022|V|OTHER USES:  This section contains uses of this drug that are not||
0276|023|V|listed in the approved professional labeling for the drug but||
0276|024|V|that may be prescribed by your health care professional. Use this||
0276|025|V|drug for a condition that is listed in this section only if it||
0276|026|V|has been so prescribed by your health care professional.||
0276|027|V|   This drug may also be used to control your heart rate if you||
0276|028|V|have a fast/irregular heartbeat (such as atrial fibrillation).||
0276|029|V|Long-acting forms of diltiazem may be used for high blood||
0276|030|V|pressure. If your doctor prescribes diltiazem for high blood||
0276|031|V|pressure, check with your pharmacist to make sure you are getting||
0276|032|V|the right form of diltiazem.||
0276|033|B|||
0276|034|H|HOW TO USE:  Take this medication by mouth before meals and at||
0276|035|H|bedtime as directed by your doctor, usually 3 to 4 times a day.||
0276|036|H|   The dosage is based on your medical condition, response to||
0276|037|H|treatment, and other medications you may be taking. Be sure to||
0276|038|H|tell your doctor and pharmacist about all the products you use||
0276|039|H|(including prescription drugs, nonprescription drugs, and herbal||
0276|040|H|products). Your doctor may gradually increase your dose. Follow||
0276|041|H|your doctor's instructions carefully.||
0276|042|H|   Use this medication regularly to get the most benefit from it.||
0276|043|H|To help you remember, use it at the same times each day. This||
0276|044|H|medication must be taken regularly to prevent angina. It should||
0276|045|H|not be used to treat angina when it occurs. Use other medications||
0276|046|H|(such as sublingual nitroglycerin) to relieve an angina attack as||
0276|047|H|directed by your doctor. Consult your doctor or pharmacist for||
0276|048|H|details.||
0276|049|H|   Tell your doctor if your condition gets worse (for example,||
0276|050|H|your chest pain worsens or is more frequent).||
0276|051|B|||
0276|052|S|SIDE EFFECTS:  Dizziness, lightheadedness, weakness, nausea,||
0276|053|S|flushing, constipation, and headache may occur. If any of these||
0276|054|S|effects last or get worse, tell your doctor or pharmacist||
0276|055|S|promptly.||
0276|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
0276|057|S|slowly when rising from a sitting or lying position.||
0276|058|S|   Remember that this medication has been prescribed because your||
0276|059|S|doctor has judged that the benefit to you is greater than the||
0276|060|S|risk of side effects. Many people using this medication do not||
0276|061|S|have serious side effects.||
0276|062|S|   Tell your doctor right away if you have any serious side||
0276|063|S|effects, including: nausea/vomiting that doesn't stop, fainting,||
0276|064|S|new or worsening symptoms of heart failure (such as shortness of||
0276|065|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
0276|066|S|weight gain), slow/irregular/pounding/fast heartbeat, mental/mood||
0276|067|S|changes (such as depression, agitation), unusual dreams, severe||
0276|068|S|stomach/abdominal pain, dark urine, yellowing eyes/skin.||
0276|069|S|   A very serious allergic reaction to this drug is rare.||
0276|070|S|However, get medical help right away if you notice any symptoms||
0276|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0276|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0276|073|S|breathing.||
0276|074|S|   This is not a complete list of possible side effects. If you||
0276|075|S|notice other effects not listed above, contact your doctor or||
0276|076|S|pharmacist.||
0276|077|S|   In the US -||
0276|078|S|   Call your doctor for medical advice about side effects. You||
0276|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0276|080|S|www.fda.gov/medwatch.||
0276|081|S|   In Canada - Call your doctor for medical advice about side||
0276|082|S|effects. You may report side effects to Health Canada at||
0276|083|S|1-866-234-2345.||
0276|084|B|||
0276|085|P|PRECAUTIONS:  Before taking diltiazem, tell your doctor or||
0276|086|P|pharmacist if you are allergic to it; or if you have any other||
0276|087|P|allergies. This product may contain inactive ingredients, which||
0276|088|P|can cause allergic reactions or other problems. Talk to your||
0276|089|P|pharmacist for more details.||
0276|090|P|   Before using this medication, tell your doctor or pharmacist||
0276|091|P|your medical history, especially of: certain types of heart||
0276|092|P|rhythm problems (such as sick sinus syndrome/atrioventricular||
0276|093|P|block), liver disease, kidney disease, heart failure.||
0276|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0276|095|P|can make you more dizzy. Do not drive, use machinery, or do||
0276|096|P|anything that needs alertness until you can do it safely. Limit||
0276|097|P|alcoholic beverages. Talk to your doctor if you are using||
0276|098|P|marijuana (cannabis).||
0276|099|P|   Before having surgery, tell your doctor or dentist about all||
0276|100|P|the products you use (including prescription drugs,||
0276|101|P|nonprescription drugs, and herbal products).||
0276|102|P|   Older adults may be more sensitive to the side effects of this||
0276|103|P|drug, especially dizziness, constipation, or swelling||
0276|104|P|ankles/feet.||
0276|105|P|   During pregnancy, this medication should be used only when||
0276|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
0276|107|P|   This drug passes into breast milk and may have undesirable||
0276|108|P|effects on a nursing infant. Consult your doctor before||
0276|109|P|breastfeeding.||
0276|110|B|||
0276|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0276|112|I|medications work or increase your risk for serious side effects.||
0276|113|I|This document does not contain all possible drug interactions.||
0276|114|I|Keep a list of all the products you use (including||
0276|115|I|prescription/nonprescription drugs and herbal products) and share||
0276|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
0276|117|I|the dosage of any medicines without your doctor's approval.||
0276|118|I|   Some products that may interact with this drug include:||
0276|119|I|digoxin, fingolimod, labetalol.||
0276|120|I|   Other medications can affect the removal of diltiazem from||
0276|121|I|your body, which may affect how this medication works. Examples||
0276|122|I|include azole antifungals (such as ketoconazole), cimetidine,||
0276|123|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
0276|124|I|rifabutin, rifampin), St. John's wort, among others.||
0276|125|I|   This medication can slow down the removal of other medications||
0276|126|I|from your body, which may affect how they work. Examples of||
0276|127|I|affected drugs include aprepitant/fosaprepitant, buspirone,||
0276|128|I|colchicine, elacestrant, flibanserin, ivabradine, lomitapide,||
0276|129|I|certain benzodiazepines (triazolam, midazolam), among others.||
0276|130|I|   Some products have ingredients that could raise your heart||
0276|131|I|rate or worsen your chest pain. Tell your pharmacist what||
0276|132|I|products you are using, and ask how to use them safely||
0276|133|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0276|134|I|ibuprofen/naproxen).||
0276|135|B|||
0276|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0276|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0276|138|O|poison control center right away. US residents can call||
0276|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0276|140|B|||
0276|141|N|NOTES:  Do not share this medication with others.||
0276|142|N|   Lab and/or medical tests (such as kidney/liver function,||
0276|143|N|pulse, blood pressure, EKG) may be done while you are taking this||
0276|144|N|medication. Keep all medical and lab appointments. Consult your||
0276|145|N|doctor for more details.||
0276|146|N|   There are different brands and types of this medication||
0276|147|N|available. Many do not have the same effects. Do not change||
0276|148|N|brands or types without consulting your doctor or pharmacist.||
0276|149|B|||
0276|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0276|151|D|remember. If it is near the time of the next dose, skip the||
0276|152|D|missed dose. Take your next dose at the regular time. Do not||
0276|153|D|double the dose to catch up.||
0276|154|B|||
0276|155|R|STORAGE:  Store at room temperature away from light and moisture.||
0276|156|R|Do not store in the bathroom. Keep all medications away from||
0276|157|R|children and pets.||
0276|158|R|   Do not flush medications down the toilet or pour them into a||
0276|159|R|drain unless instructed to do so. Properly discard this product||
0276|160|R|when it is expired or no longer needed. Consult your pharmacist||
0276|161|R|or local waste disposal company.||
0276|162|B|||
0276|163|M|MEDICAL ALERT:  Your condition can cause complications in a||
0276|164|M|medical emergency. For information about enrolling in MedicAlert,||
0276|165|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0276|166|B|||
0276|167|A|Information last revised March 2025.||
0276|168|A|Copyright(c) 2025 First Databank, Inc.||
0276|169|B|||
0277|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0277|002|Z|does NOT have all possible information about this product. This||
0277|003|Z|information does not assure that this product is safe, effective,||
0277|004|Z|or appropriate for you. This information is not individual||
0277|005|Z|medical advice and does not substitute for the advice of your||
0277|006|Z|health care professional. Always ask your health care||
0277|007|Z|professional for complete information about this product and your||
0277|008|Z|specific health needs.||
0277|009|B|||
0277|010|T|ZAFIRLUKAST - ORAL||
0277|011|F|(ZA-fir-LOO-kast)||
0277|012|B|||
0277|013|C|COMMON BRAND NAME(S): Accolate||
0277|014|B|||
0277|015|U|USES:  Zafirlukast is used to control and prevent symptoms (such||
0277|016|U|as wheezing and shortness of breath) caused by asthma.||
0277|017|U|Controlling symptoms of asthma helps you maintain your normal||
0277|018|U|activities and cuts down on time lost from work or school.||
0277|019|U|   This medication must be used regularly to be effective. It||
0277|020|U|does not work right away and should not be used to relieve sudden||
0277|021|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
0277|022|U|inhaler (such as albuterol, salbutamol) as prescribed.||
0277|023|B|||
0277|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0277|025|H|from your pharmacist before you start taking zafirlukast and each||
0277|026|H|time you get a refill. If you have any questions, ask your doctor||
0277|027|H|or pharmacist.||
0277|028|H|   Take this medication by mouth without food as directed by your||
0277|029|H|doctor, usually 2 times daily. Take zafirlukast on an empty||
0277|030|H|stomach at least 1 hour before or 2 hours after meals. The dosage||
0277|031|H|is based on your age.||
0277|032|H|   Use this medication regularly to get the most benefit from it.||
0277|033|H|To help you remember, take it at the same times each day. Keep||
0277|034|H|taking this medication even if you feel well. Do not increase||
0277|035|H|your dose, use this drug more often, or stop using it without||
0277|036|H|first consulting your doctor.||
0277|037|H|   Get medical help right away if your asthma symptoms worsen or||
0277|038|H|if you are using your quick-relief inhaler more than usual or||
0277|039|H|more often than prescribed.||
0277|040|B|||
0277|041|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0277|042|S|because your doctor has judged that the benefit to you is greater||
0277|043|S|than the risk of side effects. Many people using this medication||
0277|044|S|do not have serious side effects.||
0277|045|S|   Tell your doctor right away if you have any serious side||
0277|046|S|effects, including: mental/mood changes (such as trouble||
0277|047|S|sleeping, agitation, hallucinations, depression, thoughts of||
0277|048|S|suicide), signs of infection (such as sore throat that doesn't go||
0277|049|S|away, fever, chills), numbness/tingling of arms/legs, chest pain,||
0277|050|S|coughing up blood, worsening shortness of breath, muscle/joint||
0277|051|S|pain, swelling ankles/feet.||
0277|052|S|   This drug may rarely cause serious (possibly fatal) liver||
0277|053|S|disease. Get medical help right away if you have any symptoms of||
0277|054|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
0277|055|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0277|056|S|urine.||
0277|057|S|   A very serious allergic reaction to this drug is rare.||
0277|058|S|However, get medical help right away if you notice any symptoms||
0277|059|S|of a serious allergic reaction, including: rash, itching/swelling||
0277|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0277|061|S|breathing.||
0277|062|S|   This is not a complete list of possible side effects. If you||
0277|063|S|notice other effects not listed above, contact your doctor or||
0277|064|S|pharmacist.||
0277|065|S|   In the US -||
0277|066|S|   Call your doctor for medical advice about side effects. You||
0277|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0277|068|S|www.fda.gov/medwatch.||
0277|069|S|   In Canada - Call your doctor for medical advice about side||
0277|070|S|effects. You may report side effects to Health Canada at||
0277|071|S|1-866-234-2345.||
0277|072|B|||
0277|073|P|PRECAUTIONS:  Before taking zafirlukast, tell your doctor or||
0277|074|P|pharmacist if you are allergic to it; or if you have any other||
0277|075|P|allergies. This product may contain inactive ingredients, which||
0277|076|P|can cause allergic reactions or other problems. Talk to your||
0277|077|P|pharmacist for more details.||
0277|078|P|   Before using this medication, tell your doctor or pharmacist||
0277|079|P|your medical history, especially of: liver disease, alcohol use.||
0277|080|P|   Before having surgery, tell your doctor or dentist about all||
0277|081|P|the products you use (including prescription drugs,||
0277|082|P|nonprescription drugs, and herbal products).||
0277|083|P|   Older adults may be more sensitive to the side effects of this||
0277|084|P|drug.||
0277|085|P|   During pregnancy, this medication should be used only when||
0277|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
0277|087|P|   This medication passes into breast milk. Consult your doctor||
0277|088|P|before breastfeeding.||
0277|089|B|||
0277|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0277|091|I|medications work or increase your risk for serious side effects.||
0277|092|I|This document does not contain all possible drug interactions.||
0277|093|I|Keep a list of all the products you use (including||
0277|094|I|prescription/nonprescription drugs and herbal products) and share||
0277|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
0277|096|I|the dosage of any medicines without your doctor's approval.||
0277|097|I|   Other medications can affect the removal of zafirlukast from||
0277|098|I|your body, which may affect how zafirlukast works. An example is||
0277|099|I|erythromycin, among others.||
0277|100|I|   This medication can slow down the removal of other medications||
0277|101|I|from your body, which may affect how they work. An example is||
0277|102|I|warfarin, among others.||
0277|103|B|||
0277|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0277|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0277|106|O|poison control center right away. US residents can call||
0277|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0277|108|B|||
0277|109|N|NOTES:  Do not share this medication with others.||
0277|110|N|   Lab and/or medical tests (such as liver/lung function) should||
0277|111|N|be done while you are taking this medication. Keep all medical||
0277|112|N|and lab appointments. Consult your doctor for more details.||
0277|113|N|   Avoid substances that can worsen breathing problems by causing||
0277|114|N|irritation or allergic reaction, such as smoke, pollen, pet||
0277|115|N|dander, dust, and mold.||
0277|116|B|||
0277|117|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0277|118|D|remember. If it is near the time of the next dose, skip the||
0277|119|D|missed dose. Take your next dose at the regular time. Do not||
0277|120|D|double the dose to catch up.||
0277|121|B|||
0277|122|R|STORAGE:  Store at room temperature away from light and moisture.||
0277|123|R|Do not store in the bathroom. Keep all medications away from||
0277|124|R|children and pets.||
0277|125|R|   Do not flush medications down the toilet or pour them into a||
0277|126|R|drain unless instructed to do so. Properly discard this product||
0277|127|R|when it is expired or no longer needed. Consult your pharmacist||
0277|128|R|or local waste disposal company.||
0277|129|B|||
0277|130|M|MEDICAL ALERT:  Your condition can cause complications in a||
0277|131|M|medical emergency. For information about enrolling in MedicAlert,||
0277|132|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0277|133|B|||
0277|134|A|Information last revised April 2025.||
0277|135|A|Copyright(c) 2025 First Databank, Inc.||
0277|136|B|||
0278|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0278|002|Z|does NOT have all possible information about this product. This||
0278|003|Z|information does not assure that this product is safe, effective,||
0278|004|Z|or appropriate for you. This information is not individual||
0278|005|Z|medical advice and does not substitute for the advice of your||
0278|006|Z|health care professional. Always ask your health care||
0278|007|Z|professional for complete information about this product and your||
0278|008|Z|specific health needs.||
0278|009|B|||
0278|010|T|OPIUM/BELLADONNA SUPPOSITORY - RECTAL||
0278|011|F|(OH-pee-um/BEL-a-DON-a)||
0278|012|B|||
0278|013|W|WARNING:  Opium/belladonna has a risk for abuse and addiction,||
0278|014|W|which can lead to overdose and death. Opium/belladonna may also||
0278|015|W|cause severe, possibly fatal, breathing problems. To lower your||
0278|016|W|risk, your doctor should have you use the smallest dose of||
0278|017|W|opium/belladonna that works, and use it for the shortest possible||
0278|018|W|time. See also How to Use section for more information about||
0278|019|W|addiction.||
0278|020|W|   Ask your doctor or pharmacist if you should have medication||
0278|021|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0278|022|W|Teach your family or household members about the signs of an||
0278|023|W|opioid overdose and how to treat it.||
0278|024|W|   The risk for severe breathing problems is higher when you||
0278|025|W|start this product and after a dose increase, or if you use the||
0278|026|W|wrong dose/strength. Using this product with alcohol or other||
0278|027|W|drugs that can cause drowsiness or breathing problems may cause||
0278|028|W|very serious side effects, including death. Be sure you know how||
0278|029|W|to use this product and what other drugs you should avoid taking||
0278|030|W|with it. See also Drug Interactions section. Get medical help||
0278|031|W|right away if any of these very serious side effects occur:||
0278|032|W|slow/shallow breathing, unusual lightheadedness, severe||
0278|033|W|drowsiness/dizziness, difficulty waking up.||
0278|034|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0278|035|W|or abuse. If someone accidentally uses or swallows this drug, get||
0278|036|W|medical help right away.||
0278|037|W|   Before using this product, women of childbearing age should||
0278|038|W|talk with their doctor(s) about the risks and benefits. Tell your||
0278|039|W|doctor if you are pregnant or if you plan to become pregnant.||
0278|040|W|During pregnancy, this medication should be used only when||
0278|041|W|clearly needed. It may slightly increase the risk of birth||
0278|042|W|defects if used during the first two months of pregnancy. Also,||
0278|043|W|using it for a long time or in high doses near the expected||
0278|044|W|delivery date may harm the unborn baby. To lessen the risk, use||
0278|045|W|the smallest effective dose for the shortest possible time.||
0278|046|W|Babies born to mothers who use this drug for a long time may||
0278|047|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0278|048|W|doctor right away if you notice any symptoms in your newborn baby||
0278|049|W|such as crying that doesn't stop, slow/shallow breathing,||
0278|050|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0278|051|W|difficulty gaining weight.||
0278|052|B|||
0278|053|U|USES:  This product is used to treat moderate to severe pain from||
0278|054|U|spasms of the urinary tract. It contains 2 medications,||
0278|055|U|belladonna and opium. Belladonna helps to decrease the spasms.||
0278|056|U|Opium is an opioid medication that helps to relieve pain.||
0278|057|U|   This product is not recommended for use in children 12 years||
0278|058|U|or younger.||
0278|059|B|||
0278|060|H|HOW TO USE:  Read the Medication Guide provided by your||
0278|061|H|pharmacist before you start using opium/belladonna and each time||
0278|062|H|you get a refill. If you have any questions, ask your doctor or||
0278|063|H|pharmacist.||
0278|064|H|   Wash your hands before and after using the suppository. Unwrap||
0278|065|H|the suppository and moisten it with water. Insert 1 suppository||
0278|066|H|into the rectum as directed by your doctor. Lie down on your left||
0278|067|H|side with right knee bent. Gently push the suppository into the||
0278|068|H|rectum with your finger. Remain lying down for a few minutes, and||
0278|069|H|avoid having a bowel movement for an hour or longer so the drug||
0278|070|H|will be absorbed. The suppository is for use in the rectum only.||
0278|071|H|   If you have nausea, ask your doctor or pharmacist about ways||
0278|072|H|to decrease nausea (such as lying down for 1 to 2 hours with as||
0278|073|H|little head movement as possible).||
0278|074|H|   The dosage is based on your medical condition and response to||
0278|075|H|treatment. Do not increase your dose, use the medication more||
0278|076|H|often, or use it for a longer time than prescribed. Properly stop||
0278|077|H|the medication when so directed.||
0278|078|H|   Pain medications work best if they are used when the first||
0278|079|H|signs of pain occur. If you wait until the pain has worsened, the||
0278|080|H|medication may not work as well.||
0278|081|H|   If you suddenly stop using this medication, you may have||
0278|082|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
0278|083|H|nose, nausea, sweating, muscle aches). To help prevent||
0278|084|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0278|085|H|more likely if you have used this medication for a long time or||
0278|086|H|in high doses. Tell your doctor or pharmacist right away if you||
0278|087|H|have withdrawal.||
0278|088|H|   When this medication is used for a long time, it may not work||
0278|089|H|as well. Your doctor may need to increase your dose or change||
0278|090|H|your medication. Talk with your doctor if this medication stops||
0278|091|H|working well.||
0278|092|H|   Though it helps many people, this medication may sometimes||
0278|093|H|cause addiction. This risk may be higher if you have a||
0278|094|H|mental/mood disorder or a substance use disorder (such as overuse||
0278|095|H|of or addiction to drugs/alcohol). Use this medication exactly as||
0278|096|H|prescribed to lower the risk of addiction. Ask your doctor or||
0278|097|H|pharmacist for more details.||
0278|098|H|   Tell your doctor if your pain does not get better or if it||
0278|099|H|gets worse, or if you have any new pain.||
0278|100|B|||
0278|101|S|SIDE EFFECTS:  See also Warning section.||
0278|102|S|   Nausea, vomiting, constipation, blurred vision, increased eye||
0278|103|S|discomfort in bright light, lightheadedness, dizziness,||
0278|104|S|drowsiness, increased/decreased sweating, or dry mouth may occur.||
0278|105|S|If any of these effects last or get worse, tell your doctor or||
0278|106|S|pharmacist promptly.||
0278|107|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0278|108|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0278|109|S|substitute.||
0278|110|S|   To prevent constipation, eat dietary fiber, drink enough||
0278|111|S|water, and exercise. You may also need to take a laxative. Ask||
0278|112|S|your pharmacist which type of laxative is right for you.||
0278|113|S|   To reduce the risk of dizziness and lightheadedness, get up||
0278|114|S|slowly when rising from a sitting or lying position.||
0278|115|S|   Remember that this medication has been prescribed because your||
0278|116|S|doctor has judged that the benefit to you is greater than the||
0278|117|S|risk of side effects. Many people using this medication do not||
0278|118|S|have serious side effects.||
0278|119|S|   Tell your doctor right away if you have any serious side||
0278|120|S|effects, including: mental/mood changes (such as agitation,||
0278|121|S|hallucinations, confusion), difficulty urinating, fainting,||
0278|122|S|slow/fast heartbeat, eye pain, vision changes, signs of your||
0278|123|S|adrenal glands not working well (such as loss of appetite,||
0278|124|S|unusual tiredness, weight loss), trouble swallowing.||
0278|125|S|   Get medical help right away if you have any very serious side||
0278|126|S|effects, including: severe stomach/abdominal pain, seizures,||
0278|127|S|slow/shallow breathing, severe drowsiness/difficulty waking up.||
0278|128|S|   A very serious allergic reaction to this drug is rare.||
0278|129|S|However, get medical help right away if you notice any symptoms||
0278|130|S|of a serious allergic reaction, including: rash, itching/swelling||
0278|131|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0278|132|S|breathing.||
0278|133|S|   This is not a complete list of possible side effects. If you||
0278|134|S|notice other effects not listed above, contact your doctor or||
0278|135|S|pharmacist.||
0278|136|S|   In the US -||
0278|137|S|   Call your doctor for medical advice about side effects. You||
0278|138|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0278|139|S|www.fda.gov/medwatch.||
0278|140|S|   In Canada - Call your doctor for medical advice about side||
0278|141|S|effects. You may report side effects to Health Canada at||
0278|142|S|1-866-234-2345.||
0278|143|B|||
0278|144|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0278|145|P|pharmacist if you are allergic to belladonna or opium; or to||
0278|146|P|opioid pain medications (such as morphine, codeine); or to||
0278|147|P|atropine or scopolamine; or if you have any other allergies. This||
0278|148|P|product may contain inactive ingredients, which can cause||
0278|149|P|allergic reactions or other problems. Talk to your pharmacist for||
0278|150|P|more details.||
0278|151|P|   Before using this medication, tell your doctor or pharmacist||
0278|152|P|your medical history, especially of: kidney disease, liver||
0278|153|P|disease, brain disorders (such as head injury, tumor, seizures),||
0278|154|P|breathing problems (such as asthma, sleep apnea, chronic||
0278|155|P|obstructive pulmonary disease-COPD), a certain spinal problem||
0278|156|P|(kyphoscoliosis), difficulty urinating (such as due to enlarged||
0278|157|P|prostate), personal or family history of a substance use disorder||
0278|158|P|(such as overuse of or addiction to drugs/alcohol), heart||
0278|159|P|problems (such as irregular heartbeat, heart failure, coronary||
0278|160|P|artery disease), gallbladder disease, disease of the pancreas||
0278|161|P|(pancreatitis), adrenal gland problems (such as Addison's||
0278|162|P|disease), mental/mood disorders (such as toxic psychosis),||
0278|163|P|stomach/intestinal problems (such as blockage, constipation,||
0278|164|P|diarrhea due to infection, paralytic ileus), glaucoma, a certain||
0278|165|P|muscle/nerve disease (myasthenia gravis).||
0278|166|P|   This drug may make you dizzy or drowsy or blur your vision.||
0278|167|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0278|168|P|drowsy. Do not drive, use machinery, or do anything that needs||
0278|169|P|alertness or clear vision until you can do it safely. Avoid||
0278|170|P|alcoholic beverages. Talk to your doctor if you are using||
0278|171|P|marijuana (cannabis).||
0278|172|P|   Before having surgery, tell your doctor or dentist about all||
0278|173|P|the products you use (including prescription drugs,||
0278|174|P|nonprescription drugs, and herbal products).||
0278|175|P|   This medication may make you sweat less, making you more||
0278|176|P|likely to get heat stroke. Avoid doing things that may cause you||
0278|177|P|to overheat, such as hard work or exercise in hot weather, or||
0278|178|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0278|179|P|and dress lightly. If you overheat, quickly look for a place to||
0278|180|P|cool down and rest. Get medical help right away if you have a||
0278|181|P|fever that does not go away, mental/mood changes, headache, or||
0278|182|P|dizziness.||
0278|183|P|   Older adults may be more sensitive to the effects of this||
0278|184|P|drug, especially slow/shallow breathing and drowsiness.||
0278|185|P|   During pregnancy, this medication should be used only when||
0278|186|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0278|187|P|benefits with your doctor. (See also Warning section.)||
0278|188|P|   It is unknown if belladonna passes into breast milk. Opium||
0278|189|P|passes into breast milk. Consult your doctor before||
0278|190|P|breastfeeding.||
0278|191|B|||
0278|192|I|DRUG INTERACTIONS:  See also Warning section.||
0278|193|I|   Drug interactions may change how your medications work or||
0278|194|I|increase your risk for serious side effects. This document does||
0278|195|I|not contain all possible drug interactions. Keep a list of all||
0278|196|I|the products you use (including prescription/nonprescription||
0278|197|I|drugs and herbal products) and share it with your doctor and||
0278|198|I|pharmacist. Do not start, stop, or change the dosage of any||
0278|199|I|medicines without your doctor's approval.||
0278|200|I|   Some products that may interact with this drug are: certain||
0278|201|I|pain medications (mixed opioid agonist-antagonists such as||
0278|202|I|butorphanol, nalbuphine, pentazocine), cimetidine, naltrexone,||
0278|203|I|potassium tablets/capsules, pramlintide, rifampin, samidorphan.||
0278|204|I|   The risk of serious side effects (such as slow/shallow||
0278|205|I|breathing, severe drowsiness/dizziness) may be increased if this||
0278|206|I|medication is taken with other products that may also cause||
0278|207|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0278|208|I|if you are taking other products such as other opioid pain or||
0278|209|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0278|210|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0278|211|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0278|212|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0278|213|I|cetirizine, diphenhydramine).||
0278|214|I|   Check the labels on all your medicines (such as allergy or||
0278|215|I|cough-and-cold products) because they may contain ingredients||
0278|216|I|that cause drowsiness. Ask your pharmacist about using those||
0278|217|I|products safely.||
0278|218|I|   This medication may interfere with certain lab tests (such as||
0278|219|I|amylase and lipase levels), possibly causing false test results.||
0278|220|I|Make sure lab personnel and all your doctors know you use this||
0278|221|I|drug.||
0278|222|B|||
0278|223|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0278|224|O|has overdosed and has serious symptoms such as passing out or||
0278|225|O|trouble breathing, give them naloxone or nalmefene if available,||
0278|226|O|then call 911. If the person is awake and has no symptoms, call a||
0278|227|O|poison control center right away. US residents can call||
0278|228|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0278|229|O|Symptoms of overdose may include: severe drowsiness, slow/shallow||
0278|230|O|breathing, severe dizziness, fast heartbeat, coma.||
0278|231|B|||
0278|232|N|NOTES:  Do not share this medication with others. Sharing it is||
0278|233|N|against the law.||
0278|234|N|   This medication has been prescribed for your current condition||
0278|235|N|only. Do not use it later for another condition unless told to do||
0278|236|N|so by your doctor. A different medication may be necessary in||
0278|237|N|that case.||
0278|238|B|||
0278|239|D|MISSED DOSE:  If you are using this medication regularly and miss||
0278|240|D|a dose, use it as soon as you remember. If it is near the time of||
0278|241|D|the next dose, skip the missed dose. Use your next dose at the||
0278|242|D|regular time. Do not double the dose to catch up.||
0278|243|B|||
0278|244|R|STORAGE:  Store at room temperature away from moisture. Do not||
0278|245|R|refrigerate. Do not store in the bathroom. Keep all medications||
0278|246|R|away from children and pets.||
0278|247|R|   Do not flush medications down the toilet or pour them into a||
0278|248|R|drain unless instructed to do so. Properly discard this product||
0278|249|R|when it is expired or no longer needed. Consult your pharmacist||
0278|250|R|or local waste disposal company.||
0278|251|B|||
0278|252|A|Information last revised August 2025.||
0278|253|A|Copyright(c) 2025 First Databank, Inc.||
0278|254|B|||
0279|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0279|002|Z|does NOT have all possible information about this product. This||
0279|003|Z|information does not assure that this product is safe, effective,||
0279|004|Z|or appropriate for you. This information is not individual||
0279|005|Z|medical advice and does not substitute for the advice of your||
0279|006|Z|health care professional. Always ask your health care||
0279|007|Z|professional for complete information about this product and your||
0279|008|Z|specific health needs.||
0279|009|B|||
0279|010|T|PENCICLOVIR CREAM - TOPICAL||
0279|011|F|(pen-SYE-kloe-vir)||
0279|012|B|||
0279|013|C|COMMON BRAND NAME(S): Denavir||
0279|014|B|||
0279|015|U|USES:  This medication is used to treat "cold sores/fever||
0279|016|U|blisters" (herpes labialis). It can speed up healing of the sores||
0279|017|U|and decrease symptoms (such as tingling, pain, burning, itching).||
0279|018|U|Penciclovir belongs to a class of medications known as||
0279|019|U|antivirals. It works by stopping the growth of the virus. This||
0279|020|U|medication does not cure herpes, and it does not prevent passing||
0279|021|U|the infection to someone else. It does not prevent future||
0279|022|U|occurrences.||
0279|023|B|||
0279|024|H|HOW TO USE:  Use this medication at the first sign of infection||
0279|025|H|(such as tingling, burning, redness, or sores). Wash your hands||
0279|026|H|with soap and water before and after applying this medication.||
0279|027|H|Clean and dry the affected areas before applying the medication.||
0279|028|H|Apply a thin layer of penciclovir cream to completely cover the||
0279|029|H|area of the cold sore or the area of||
0279|030|H|tingling/itching/redness/swelling, and rub in gently. Apply the||
0279|031|H|cream as directed by your doctor, usually every 2 hours (except||
0279|032|H|during sleep) for 4 days.||
0279|033|H|   Apply to skin only. Do not apply this medication in or near||
0279|034|H|the eyes since this medication can irritate the eyes. If you do||
0279|035|H|get medication in your eyes, flush with plenty of water. Do not||
0279|036|H|apply inside the mouth or nose.||
0279|037|H|   Dosage is based on your medical condition and response to||
0279|038|H|treatment. Do not use this drug more often or for longer than||
0279|039|H|prescribed.||
0279|040|H|   Use this medication regularly to get the most benefit from it.||
0279|041|H|This medication works best when the amount of drug absorbed by||
0279|042|H|the skin stays at a constant level. Use this drug at evenly||
0279|043|H|spaced intervals. To help you remember, use it at the same times||
0279|044|H|each day.||
0279|045|H|   Cold sores (herpes) can spread easily. Penciclovir cream does||
0279|046|H|not prevent the spread of herpes. Avoid close physical contact||
0279|047|H|with others (such as kissing) during an outbreak until the cold||
0279|048|H|sores have completely healed. Also, try not to touch the cold||
0279|049|H|sore, and wash your hands if you do touch the cold sore.||
0279|050|H|   Tell your doctor if your condition lasts or gets worse after||
0279|051|H|treatment is finished.||
0279|052|B|||
0279|053|S|SIDE EFFECTS:  Redness, burning, stinging, or numbness may occur.||
0279|054|S|If any of these effects last or get worse, tell your doctor or||
0279|055|S|pharmacist promptly.||
0279|056|S|   Remember that this medication has been prescribed because your||
0279|057|S|doctor has judged that the benefit to you is greater than the||
0279|058|S|risk of side effects. Many people using this medication do not||
0279|059|S|have serious side effects.||
0279|060|S|   A very serious allergic reaction to this drug is rare.||
0279|061|S|However, get medical help right away if you notice any symptoms||
0279|062|S|of a serious allergic reaction, including: rash, itching/swelling||
0279|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0279|064|S|breathing.||
0279|065|S|   This is not a complete list of possible side effects. If you||
0279|066|S|notice other effects not listed above, contact your doctor or||
0279|067|S|pharmacist.||
0279|068|S|   In the US -||
0279|069|S|   Call your doctor for medical advice about side effects. You||
0279|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0279|071|S|www.fda.gov/medwatch.||
0279|072|S|   In Canada - Call your doctor for medical advice about side||
0279|073|S|effects. You may report side effects to Health Canada at||
0279|074|S|1-866-234-2345.||
0279|075|B|||
0279|076|P|PRECAUTIONS:  Before using penciclovir, tell your doctor or||
0279|077|P|pharmacist if you are allergic to it; or to famciclovir; or if||
0279|078|P|you have any other allergies. This product may contain inactive||
0279|079|P|ingredients, which can cause allergic reactions or other||
0279|080|P|problems. Talk to your pharmacist for more details.||
0279|081|P|   Before using this medication, tell your doctor or pharmacist||
0279|082|P|your medical history.||
0279|083|P|   Tell your doctor if you are pregnant before using this||
0279|084|P|medication.||
0279|085|P|   This medication does not pass into breast milk. Consult your||
0279|086|P|doctor before breastfeeding.||
0279|087|B|||
0279|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0279|089|I|medications work or increase your risk for serious side effects.||
0279|090|I|This document does not contain all possible drug interactions.||
0279|091|I|Keep a list of all the products you use (including||
0279|092|I|prescription/nonprescription drugs and herbal products) and share||
0279|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
0279|094|I|the dosage of any medicines without your doctor's approval.||
0279|095|B|||
0279|096|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0279|097|O|has overdosed and has serious symptoms such as passing out or||
0279|098|O|trouble breathing, call 911. Otherwise, call a poison control||
0279|099|O|center right away. US residents can call 1-800-222-1222. Canada||
0279|100|O|residents can call 1-844-764-7669.||
0279|101|B|||
0279|102|N|NOTES:  Do not share this medication with others. Doing so may||
0279|103|N|spread the infection.||
0279|104|N|   Cold sore outbreaks can be triggered by many factors such as||
0279|105|N|stress, hormonal changes (such as pregnancy, menstrual period),||
0279|106|N|injury/surgery on the mouth (such as dental work), tiredness,||
0279|107|N|sunlight, cold weather, or fever/cold/flu.||
0279|108|B|||
0279|109|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0279|110|D|If it is near the time of the next dose, skip the missed dose.||
0279|111|D|Use your next dose at the regular time. Do not double the dose to||
0279|112|D|catch up.||
0279|113|B|||
0279|114|R|STORAGE:  Store this medication at room temperature. Firmly screw||
0279|115|R|the cap back on the tube of medication after each use. Keep all||
0279|116|R|medications away from children and pets.||
0279|117|R|   Do not flush medications down the toilet or pour them into a||
0279|118|R|drain unless instructed to do so. Properly discard this product||
0279|119|R|when it is expired or no longer needed. Consult your pharmacist||
0279|120|R|or local waste disposal company.||
0279|121|B|||
0279|122|A|Information last revised May 2024.||
0279|123|A|Copyright(c) 2025 First Databank, Inc.||
0279|124|B|||
0280|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0280|002|Z|does NOT have all possible information about this product. This||
0280|003|Z|information does not assure that this product is safe, effective,||
0280|004|Z|or appropriate for you. This information is not individual||
0280|005|Z|medical advice and does not substitute for the advice of your||
0280|006|Z|health care professional. Always ask your health care||
0280|007|Z|professional for complete information about this product and your||
0280|008|Z|specific health needs.||
0280|009|B|||
0280|010|T|MULTIVITAMINS W/IRON (INCLUDES PRENATAL VITAMINS) - ORAL||
0280|011|B|||
0280|012|W|WARNING:  Accidental overdose of iron-containing products is a||
0280|013|W|leading cause of fatal poisoning in children younger than 6||
0280|014|W|years. Keep this product out of reach of children. If overdose||
0280|015|W|does occur, get medical help right away or call a poison control||
0280|016|W|center.||
0280|017|B|||
0280|018|U|USES:  This medication is a multivitamin and iron product used to||
0280|019|U|treat or prevent vitamin deficiency due to poor diet, certain||
0280|020|U|illnesses, or during pregnancy. Vitamins and iron are important||
0280|021|U|building blocks of the body and help keep you in good health.||
0280|022|B|||
0280|023|H|HOW TO USE:  Take this medication by mouth, usually once daily or||
0280|024|H|as directed. Follow all directions on the product package, or||
0280|025|H|take as directed by your doctor. Do not take more than the||
0280|026|H|recommended dosage. If you have any questions, ask your doctor or||
0280|027|H|pharmacist.||
0280|028|H|   This medication is best taken on an empty stomach 1 hour||
0280|029|H|before or 2 hours after meals. Take with a full glass of water (8||
0280|030|H|ounces or 240 milliliters) unless your doctor directs you||
0280|031|H|otherwise. If stomach upset occurs, you may take this medication||
0280|032|H|with food. Avoid taking antacids, dairy products, tea, or coffee||
0280|033|H|within 2 hours before or after this medication because they may||
0280|034|H|decrease its effectiveness. Do not lie down for at least 10||
0280|035|H|minutes after taking the tablets or capsules. Consult your doctor||
0280|036|H|or pharmacist for details for your particular brand.||
0280|037|H|   If you are taking the delayed-release form or extended-release||
0280|038|H|capsules, swallow them whole. Do not crush or chew||
0280|039|H|delayed-release or extended-release products. Doing so can||
0280|040|H|release all of the drug at once, increasing the risk of side||
0280|041|H|effects and decreasing absorption. Also, do not split||
0280|042|H|extended-release tablets unless they have a score line and your||
0280|043|H|doctor or pharmacist tells you to do so. Swallow the whole or||
0280|044|H|split tablet without crushing or chewing.||
0280|045|H|   Take this medication regularly in order to get the most||
0280|046|H|benefit from it. To help you remember, take it at the same time||
0280|047|H|each day.||
0280|048|B|||
0280|049|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
0280|050|S|occur. These effects are usually temporary and may disappear as||
0280|051|S|your body adjusts to this medication. If any of these effects||
0280|052|S|last or get worse, contact your doctor or pharmacist promptly.||
0280|053|S|   Iron may cause your stools to turn black, an effect that is||
0280|054|S|not harmful.||
0280|055|S|   If your doctor has prescribed this medication, remember that||
0280|056|S|your doctor has judged that the benefit to you is greater than||
0280|057|S|the risk of side effects. Many people using this medication do||
0280|058|S|not have serious side effects.||
0280|059|S|   A very serious allergic reaction to this drug is rare.||
0280|060|S|However, get medical help right away if you notice any symptoms||
0280|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0280|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0280|063|S|breathing.||
0280|064|S|   This is not a complete list of possible side effects. If you||
0280|065|S|notice other effects not listed above, contact your doctor or||
0280|066|S|pharmacist.||
0280|067|S|   In the US -||
0280|068|S|   Call your doctor for medical advice about side effects. You||
0280|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0280|070|S|www.fda.gov/medwatch.||
0280|071|S|   In Canada - Call your doctor for medical advice about side||
0280|072|S|effects. You may report side effects to Health Canada at||
0280|073|S|1-866-234-2345.||
0280|074|B|||
0280|075|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0280|076|P|pharmacist if you are allergic to any of its ingredients; or if||
0280|077|P|you have any other allergies. This product may contain inactive||
0280|078|P|ingredients (such as soy found in some brands), which can cause||
0280|079|P|allergic reactions or other problems. Talk to your pharmacist for||
0280|080|P|more details.||
0280|081|P|   Before taking this medication, tell your doctor or pharmacist||
0280|082|P|your medical history, especially of: iron overload disorder (such||
0280|083|P|as hemochromatosis, hemosiderosis), use/abuse of alcohol, liver||
0280|084|P|problems, stomach/intestinal problems (such as ulcer, colitis).||
0280|085|P|   If your brand of multivitamin also contains folic acid, be||
0280|086|P|sure to tell your doctor or pharmacist if you have vitamin B12||
0280|087|P|deficiency (pernicious anemia) before taking it. Folic acid may||
0280|088|P|affect certain lab tests for vitamin B12 deficiency without||
0280|089|P|treating this anemia. Untreated vitamin B12 deficiency may result||
0280|090|P|in serious nerve problems (such as peripheral neuropathy).||
0280|091|P|Consult your doctor or pharmacist for details.||
0280|092|P|   Before having surgery, tell your doctor or dentist about all||
0280|093|P|the products you use (including prescription drugs,||
0280|094|P|nonprescription drugs, and herbal products).||
0280|095|P|   Tell your doctor if you are pregnant before using this||
0280|096|P|medication.||
0280|097|P|   This medication passes into breast milk. Consult your doctor||
0280|098|P|before breastfeeding.||
0280|099|B|||
0280|100|I|DRUG INTERACTIONS:  See also How To Use section.||
0280|101|I|   Drug interactions may change how your medications work or||
0280|102|I|increase your risk for serious side effects. This document does||
0280|103|I|not contain all possible drug interactions. Keep a list of all||
0280|104|I|the products you use (including prescription/nonprescription||
0280|105|I|drugs and herbal products) and share it with your doctor and||
0280|106|I|pharmacist. Do not start, stop, or change the dosage of any||
0280|107|I|medicines without your doctor's approval.||
0280|108|I|   This product can decrease the absorption of certain drugs,||
0280|109|I|especially if you take them around the same time. These drugs||
0280|110|I|include bisphosphonates (such as alendronate), levodopa,||
0280|111|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
0280|112|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
0280|113|I|minocycline), thyroid medications (such as levothyroxine), among||
0280|114|I|others. Ask your doctor or pharmacist how long you should wait||
0280|115|I|between doses of this product and your other medications and to||
0280|116|I|find a dosing schedule that works for all your medications.||
0280|117|I|   This medication may interfere with certain lab tests, possibly||
0280|118|I|causing false test results. Make sure lab personnel and all your||
0280|119|I|doctors know you use this drug.||
0280|120|B|||
0280|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0280|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0280|123|O|poison control center right away. US residents can call||
0280|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0280|125|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
0280|126|O|diarrhea.||
0280|127|B|||
0280|128|N|NOTES:  If your doctor has prescribed this medication, do not||
0280|129|N|share it with others.||
0280|130|N|   Keep all medical and lab appointments.||
0280|131|N|   Some brands may also contain ingredients such as docusate. Ask||
0280|132|N|your doctor or pharmacist if you have questions about the||
0280|133|N|ingredients in your brand.||
0280|134|N|   This product is not a substitute for a proper diet. Remember||
0280|135|N|that it is best to get your vitamins and minerals from healthy||
0280|136|N|foods. Maintain a well-balanced diet and follow any dietary||
0280|137|N|guidelines as directed by your doctor.||
0280|138|B|||
0280|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0280|140|D|remember. If it is near the time of the next dose, skip the||
0280|141|D|missed dose. Take your next dose at the regular time. Do not||
0280|142|D|double the dose to catch up.||
0280|143|B|||
0280|144|R|STORAGE:  Store at room temperature away from light and moisture.||
0280|145|R|Do not store in the bathroom. Keep all medications away from||
0280|146|R|children and pets.||
0280|147|R|   Do not flush medications down the toilet or pour them into a||
0280|148|R|drain unless instructed to do so. Properly discard this product||
0280|149|R|when it is expired or no longer needed. Consult your pharmacist||
0280|150|R|or local waste disposal company.||
0280|151|B|||
0280|152|A|Information last revised October 2025.||
0280|153|A|Copyright(c) 2025 First Databank, Inc.||
0280|154|B|||
0281|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0281|002|Z|does NOT have all possible information about this product. This||
0281|003|Z|information does not assure that this product is safe, effective,||
0281|004|Z|or appropriate for you. This information is not individual||
0281|005|Z|medical advice and does not substitute for the advice of your||
0281|006|Z|health care professional. Always ask your health care||
0281|007|Z|professional for complete information about this product and your||
0281|008|Z|specific health needs.||
0281|009|B|||
0281|010|T|TRANDOLAPRIL - ORAL||
0281|011|F|(tran-DOL-a-pril)||
0281|012|B|||
0281|013|C|COMMON BRAND NAME(S): Mavik||
0281|014|B|||
0281|015|W|WARNING:  Trandolapril can cause serious (possibly fatal) harm to||
0281|016|W|an unborn baby if used during pregnancy. It is important to||
0281|017|W|prevent pregnancy while taking this medication. Consult your||
0281|018|W|doctor for more details and to discuss the use of reliable forms||
0281|019|W|of birth control while taking this medication. If you are||
0281|020|W|planning pregnancy, become pregnant, or think you may be||
0281|021|W|pregnant, tell your doctor right away.||
0281|022|B|||
0281|023|U|USES:  Trandolapril is used to treat high blood pressure.||
0281|024|U|Lowering high blood pressure helps prevent strokes, heart||
0281|025|U|attacks, and kidney problems. This medication is also used to||
0281|026|U|treat heart failure and to improve survival after a heart attack.||
0281|027|U|Trandolapril belongs to a class of drugs known as ACE inhibitors.||
0281|028|U|It works by relaxing blood vessels so blood can flow more easily.||
0281|029|B|||
0281|030|V|OTHER USES:  This section contains uses of this drug that are not||
0281|031|V|listed in the approved professional labeling for the drug but||
0281|032|V|that may be prescribed by your health care professional. Use this||
0281|033|V|drug for a condition that is listed in this section only if it||
0281|034|V|has been so prescribed by your health care professional.||
0281|035|V|   This medication may also be used for kidney disease and to||
0281|036|V|help protect the kidneys from harm due to diabetes.||
0281|037|B|||
0281|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0281|039|H|from your pharmacist before you start taking trandolapril and||
0281|040|H|each time you get a refill. If you have any questions, ask your||
0281|041|H|doctor or pharmacist.||
0281|042|H|   Take this medication by mouth with or without food as directed||
0281|043|H|by your doctor, usually once or twice daily. The dosage is based||
0281|044|H|on your medical condition and response to treatment.||
0281|045|H|   To reduce your risk of side effects, your doctor may direct||
0281|046|H|you to start this medication at a low dose and gradually increase||
0281|047|H|your dose. Follow your doctor's instructions carefully.||
0281|048|H|   Take this medication regularly to get the most benefit from||
0281|049|H|it. To help you remember, take it at the same time(s) each day.||
0281|050|H|Keep taking this medication even if you feel well. Most people||
0281|051|H|with high blood pressure do not feel sick.||
0281|052|H|   For the treatment of high blood pressure, it may take 1 week||
0281|053|H|before you get the full benefit of this drug. For the treatment||
0281|054|H|of heart failure, it may take several weeks to months before you||
0281|055|H|get the full benefit of this drug.||
0281|056|H|   Tell your doctor if your condition does not get better or if||
0281|057|H|it gets worse (for example, your blood pressure readings remain||
0281|058|H|high or increase).||
0281|059|B|||
0281|060|S|SIDE EFFECTS:  Dizziness, lightheadedness, or tiredness may occur||
0281|061|S|as your body adjusts to the medication. Dry cough may also occur.||
0281|062|S|If any of these effects last or get worse, tell your doctor or||
0281|063|S|pharmacist promptly.||
0281|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
0281|065|S|slowly when rising from a sitting or lying position.||
0281|066|S|   Remember that this medication has been prescribed because your||
0281|067|S|doctor has judged that the benefit to you is greater than the||
0281|068|S|risk of side effects. Many people using this medication do not||
0281|069|S|have serious side effects.||
0281|070|S|   Tell your doctor right away if you have any serious side||
0281|071|S|effects, including: symptoms of a high potassium blood level||
0281|072|S|(such as muscle weakness, slow/irregular heartbeat), fainting.||
0281|073|S|   Although trandolapril may be used to prevent kidney problems||
0281|074|S|or treat people who have kidney problems, it may also rarely||
0281|075|S|cause kidney problems or make them worse. Your doctor will check||
0281|076|S|your kidney function while you are taking this medication. Tell||
0281|077|S|your doctor right away if you have any signs of kidney problems||
0281|078|S|such as a change in the amount of urine.||
0281|079|S|   This drug may rarely cause serious (possibly fatal) liver||
0281|080|S|problems. Get medical help right away if you have any symptoms of||
0281|081|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0281|082|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0281|083|S|urine.||
0281|084|S|   A very serious allergic reaction to this drug is rare.||
0281|085|S|However, get medical help right away if you notice any symptoms||
0281|086|S|of a serious allergic reaction, including: rash, itching/swelling||
0281|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0281|088|S|breathing.||
0281|089|S|   This is not a complete list of possible side effects. If you||
0281|090|S|notice other effects not listed above, contact your doctor or||
0281|091|S|pharmacist.||
0281|092|S|   In the US -||
0281|093|S|   Call your doctor for medical advice about side effects. You||
0281|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0281|095|S|www.fda.gov/medwatch.||
0281|096|S|   In Canada - Call your doctor for medical advice about side||
0281|097|S|effects. You may report side effects to Health Canada at||
0281|098|S|1-866-234-2345.||
0281|099|B|||
0281|100|P|PRECAUTIONS:  Before taking trandolapril, tell your doctor or||
0281|101|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
0281|102|P|(such as captopril, lisinopril); or if you have any other||
0281|103|P|allergies. This product may contain inactive ingredients, which||
0281|104|P|can cause allergic reactions or other problems. Talk to your||
0281|105|P|pharmacist for more details.||
0281|106|P|   Before using this medication, tell your doctor or pharmacist||
0281|107|P|your medical history, especially of: history of an allergic||
0281|108|P|reaction which included swelling of the face/lips/tongue/throat||
0281|109|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
0281|110|P|dialysis), high level of potassium in the blood, liver disease.||
0281|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0281|112|P|can make you more dizzy. Do not drive, use machinery, or do||
0281|113|P|anything that needs alertness until you can do it safely. Limit||
0281|114|P|alcoholic beverages. Talk to your doctor if you are using||
0281|115|P|marijuana (cannabis).||
0281|116|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0281|117|P|and cause you to feel lightheaded. Tell your doctor if you have||
0281|118|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0281|119|P|of fluids unless your doctor tells you not to.||
0281|120|P|   This medication may increase your potassium levels. Before||
0281|121|P|using potassium supplements or salt substitutes that contain||
0281|122|P|potassium, consult your doctor or pharmacist.||
0281|123|P|   Before having surgery, tell your doctor or dentist about all||
0281|124|P|the products you use (including prescription drugs,||
0281|125|P|nonprescription drugs, and herbal products).||
0281|126|P|   Older adults may be more sensitive to the side effects of this||
0281|127|P|drug, especially dizziness and high potassium levels.||
0281|128|P|   Tell your doctor if you are pregnant or plan to become||
0281|129|P|pregnant. You should not become pregnant while using||
0281|130|P|trandolapril. Trandolapril may harm an unborn baby. If you become||
0281|131|P|pregnant, talk to your doctor right away about the risks and||
0281|132|P|benefits of this medication. See also Warning section.||
0281|133|P|   It is unknown if trandolapril passes into breast milk. Consult||
0281|134|P|your doctor before breastfeeding.||
0281|135|B|||
0281|136|I|DRUG INTERACTIONS:  See also Precautions section.||
0281|137|I|   Drug interactions may change how your medications work or||
0281|138|I|increase your risk for serious side effects. This document does||
0281|139|I|not contain all possible drug interactions. Keep a list of all||
0281|140|I|the products you use (including prescription/nonprescription||
0281|141|I|drugs and herbal products) and share it with your doctor and||
0281|142|I|pharmacist. Do not start, stop, or change the dosage of any||
0281|143|I|medicines without your doctor's approval.||
0281|144|I|   Some products that may interact with this drug are: aliskiren,||
0281|145|I|gold injections, lithium, sacubitril, certain drugs that weaken||
0281|146|I|the immune system/increase the risk of infection (such as||
0281|147|I|everolimus, sirolimus), drugs that may increase the level of||
0281|148|I|potassium in the blood (such as ARBs including||
0281|149|I|losartan/valsartan, birth control pills containing drospirenone).||
0281|150|I|   Some products have ingredients that could raise your blood||
0281|151|I|pressure or worsen your heart failure. Tell your pharmacist what||
0281|152|I|products you are using, and ask how to use them safely||
0281|153|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0281|154|I|ibuprofen/naproxen).||
0281|155|I|   A very serious reaction may occur if you are getting||
0281|156|I|injections for bee/wasp sting allergy (desensitization) and are||
0281|157|I|also taking trandolapril. Make sure all your doctors know which||
0281|158|I|medicines you are using.||
0281|159|B|||
0281|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0281|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0281|162|O|poison control center right away. US residents can call||
0281|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0281|164|O|Symptoms of overdose may include: unusually fast or slow||
0281|165|O|heartbeat, severe dizziness, or fainting.||
0281|166|B|||
0281|167|N|NOTES:  Do not share this medication with others.||
0281|168|N|   Lifestyle changes that may help this medication work better||
0281|169|N|include exercising, stopping smoking, and eating a||
0281|170|N|low-cholesterol/low-fat diet. Consult your doctor for more||
0281|171|N|details.||
0281|172|N|   Lab and/or medical tests (such as kidney function, potassium||
0281|173|N|levels) should be done while you are taking this medication. Keep||
0281|174|N|all medical and lab appointments. Consult your doctor for more||
0281|175|N|details.||
0281|176|N|   Check your blood pressure and pulse (heart rate) regularly||
0281|177|N|while taking this medication. Learn how to check your own blood||
0281|178|N|pressure and pulse at home, and share the results with your||
0281|179|N|doctor.||
0281|180|B|||
0281|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0281|182|D|remember. If it is near the time of the next dose, skip the||
0281|183|D|missed dose. Take your next dose at the regular time. Do not||
0281|184|D|double the dose to catch up.||
0281|185|B|||
0281|186|R|STORAGE:  Store at room temperature away from light and moisture.||
0281|187|R|Do not store in the bathroom. Keep all medications away from||
0281|188|R|children and pets.||
0281|189|R|   Do not flush medications down the toilet or pour them into a||
0281|190|R|drain unless instructed to do so. Properly discard this product||
0281|191|R|when it is expired or no longer needed. Consult your pharmacist||
0281|192|R|or local waste disposal company.||
0281|193|B|||
0281|194|A|Information last revised May 2024.||
0281|195|A|Copyright(c) 2025 First Databank, Inc.||
0281|196|B|||
0282|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0282|002|Z|does NOT have all possible information about this product. This||
0282|003|Z|information does not assure that this product is safe, effective,||
0282|004|Z|or appropriate for you. This information is not individual||
0282|005|Z|medical advice and does not substitute for the advice of your||
0282|006|Z|health care professional. Always ask your health care||
0282|007|Z|professional for complete information about this product and your||
0282|008|Z|specific health needs.||
0282|009|B|||
0282|010|T|AZELASTINE SPRAY - NASAL||
0282|011|F|(AY-ze-LAS-teen)||
0282|012|B|||
0282|013|C|COMMON BRAND NAME(S): Astelin, Astepro||
0282|014|B|||
0282|015|U|USES:  This medication is used to relieve nasal symptoms such as||
0282|016|U|runny/itching/stuffy nose, sneezing, and post-nasal drip caused||
0282|017|U|by allergies or other conditions. Azelastine belongs to a class||
0282|018|U|of drugs known as antihistamines. It works by blocking certain||
0282|019|U|natural substances called histamines that are responsible for||
0282|020|U|nasal symptoms.||
0282|021|B|||
0282|022|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0282|023|H|your pharmacist before you start using this medication and each||
0282|024|H|time you get a refill. Follow the illustrated directions for the||
0282|025|H|proper use of this medication. If you have any questions, ask||
0282|026|H|your doctor or pharmacist.||
0282|027|H|   Follow the instructions for test sprays in the air if you are||
0282|028|H|using the spray pump for the first time or if you have not used||
0282|029|H|it for 3 days or more. A fine mist is a sign that the spray pump||
0282|030|H|is working properly.||
0282|031|H|   Gently blow your nose before using this medication. Use this||
0282|032|H|medication in the nose as directed by your doctor, usually once||
0282|033|H|or twice a day in both nostrils. Do not spray it in your eyes or||
0282|034|H|mouth. The dosage is based on your medical condition, age, and||
0282|035|H|response to treatment.||
0282|036|H|   To prevent a bitter taste in your mouth, breathe in gently and||
0282|037|H|do not tilt your head back after using this medication.||
0282|038|H|   Use this medication regularly to get the most benefit from it.||
0282|039|H|To help you remember, use it at the same time(s) each day.||
0282|040|H|   Do not increase your dose or use this drug more often or for||
0282|041|H|longer than prescribed. Your condition will not improve any||
0282|042|H|faster, and your risk of side effects will increase.||
0282|043|H|   Keep track of the number of sprays used from the spray pump.||
0282|044|H|Discard the pump after you have used the number of sprays||
0282|045|H|specified on the manufacturer's package.||
0282|046|H|   This medication usually begins to work within 3 hours of use.||
0282|047|H|   Tell your doctor if you do not get better or if you get worse.||
0282|048|B|||
0282|049|S|SIDE EFFECTS:  A bitter taste in the mouth, drowsiness,||
0282|050|S|tiredness, nasal discomfort, sneezing fits, cough, nose bleeds,||
0282|051|S|runny nose, dry mouth, headache, or red eyes may occur. If any of||
0282|052|S|these effects last or get worse, tell your doctor or pharmacist||
0282|053|S|promptly.||
0282|054|S|   Remember that your doctor has prescribed this medication||
0282|055|S|because your doctor has judged that the benefit to you is greater||
0282|056|S|than the risk of side effects. Many people using this medication||
0282|057|S|do not have serious side effects.||
0282|058|S|   A very serious allergic reaction to this drug is rare.||
0282|059|S|However, get medical help right away if you notice any symptoms||
0282|060|S|of a serious allergic reaction, including: rash, itching/swelling||
0282|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0282|062|S|breathing.||
0282|063|S|   This is not a complete list of possible side effects. If you||
0282|064|S|notice other effects not listed above, contact your doctor or||
0282|065|S|pharmacist.||
0282|066|S|   In the US -||
0282|067|S|   Call your doctor for medical advice about side effects. You||
0282|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0282|069|S|www.fda.gov/medwatch.||
0282|070|S|   In Canada - Call your doctor for medical advice about side||
0282|071|S|effects. You may report side effects to Health Canada at||
0282|072|S|1-866-234-2345.||
0282|073|B|||
0282|074|P|PRECAUTIONS:  Before using azelastine, tell your doctor or||
0282|075|P|pharmacist if you are allergic to it; or if you have any other||
0282|076|P|allergies. This product may contain inactive ingredients, which||
0282|077|P|can cause allergic reactions or other problems. Talk to your||
0282|078|P|pharmacist for more details.||
0282|079|P|   Before using this medication, tell your doctor or pharmacist||
0282|080|P|your medical history, especially of: kidney problems.||
0282|081|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
0282|082|P|can make you more drowsy. Do not drive, use machinery, or do||
0282|083|P|anything that needs alertness until you can do it safely. Avoid||
0282|084|P|alcoholic beverages. Talk to your doctor if you are using||
0282|085|P|marijuana (cannabis).||
0282|086|P|   Before having surgery, tell your doctor or dentist about all||
0282|087|P|the products you use (including prescription drugs,||
0282|088|P|nonprescription drugs, and herbal products).||
0282|089|P|   During pregnancy, this medication should be used only when||
0282|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
0282|091|P|   It is unknown if this medication passes into breast milk.||
0282|092|P|Consult your doctor before breastfeeding.||
0282|093|B|||
0282|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0282|095|I|medications work or increase your risk for serious side effects.||
0282|096|I|This document does not contain all possible drug interactions.||
0282|097|I|Keep a list of all the products you use (including||
0282|098|I|prescription/nonprescription drugs and herbal products) and share||
0282|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
0282|100|I|the dosage of any medicines without your doctor's approval.||
0282|101|I|   Tell your doctor or pharmacist if you are taking other||
0282|102|I|products that cause drowsiness such as opioid pain or cough||
0282|103|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0282|104|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0282|105|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0282|106|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0282|107|I|diphenhydramine).||
0282|108|I|   Check the labels on all your medicines (such as allergy or||
0282|109|I|cough-and-cold products) because they may contain ingredients||
0282|110|I|that cause drowsiness. Ask your pharmacist about using those||
0282|111|I|products safely.||
0282|112|B|||
0282|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0282|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0282|115|O|poison control center right away. US residents can call||
0282|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0282|117|B|||
0282|118|N|NOTES:  Do not share this medication with others.||
0282|119|N|   Ask your doctor for ways to reduce your exposure to substances||
0282|120|N|(such as pollen, pet dander, dust mites, mold, smoke) that can||
0282|121|N|worsen allergy symptoms.||
0282|122|B|||
0282|123|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0282|124|D|If it is near the time of the next dose, skip the missed dose.||
0282|125|D|Use your next dose at the regular time. Do not double the dose to||
0282|126|D|catch up.||
0282|127|B|||
0282|128|R|STORAGE:  Store upright at room temperature. Do not freeze. Keep||
0282|129|R|all medications away from children and pets.||
0282|130|R|   Do not flush medications down the toilet or pour them into a||
0282|131|R|drain unless instructed to do so. Properly discard this product||
0282|132|R|when it is expired or no longer needed. Consult your pharmacist||
0282|133|R|or local waste disposal company.||
0282|134|B|||
0282|135|A|Information last revised September 2024.||
0282|136|A|Copyright(c) 2025 First Databank, Inc.||
0282|137|B|||
0284|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0284|002|Z|does NOT have all possible information about this product. This||
0284|003|Z|information does not assure that this product is safe, effective,||
0284|004|Z|or appropriate for you. This information is not individual||
0284|005|Z|medical advice and does not substitute for the advice of your||
0284|006|Z|health care professional. Always ask your health care||
0284|007|Z|professional for complete information about this product and your||
0284|008|Z|specific health needs.||
0284|009|B|||
0284|010|T|ATORVASTATIN - ORAL||
0284|011|F|(a-TOR-va-STAT-in)||
0284|012|B|||
0284|013|C|COMMON BRAND NAME(S): Lipitor||
0284|014|B|||
0284|015|U|USES:  Atorvastatin is used along with a proper diet to help||
0284|016|U|lower "bad" cholesterol and fats (such as LDL, triglycerides) and||
0284|017|U|raise "good" cholesterol (HDL) in the blood. It belongs to a||
0284|018|U|group of drugs known as "statins." It works by reducing the||
0284|019|U|amount of cholesterol made by the liver. Lowering "bad"||
0284|020|U|cholesterol and triglycerides and raising "good" cholesterol||
0284|021|U|decreases the risk of heart disease and helps prevent strokes and||
0284|022|U|heart attacks.||
0284|023|U|   In addition to eating a proper diet (such as a||
0284|024|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
0284|025|U|help this medication work better include exercising, losing||
0284|026|U|weight if overweight, and stopping smoking. Consult your doctor||
0284|027|U|for more details.||
0284|028|B|||
0284|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0284|030|H|from your pharmacist before you start taking atorvastatin and||
0284|031|H|each time you get a refill. If you have any questions, ask your||
0284|032|H|doctor or pharmacist.||
0284|033|H|   Take this medication by mouth with or without food as directed||
0284|034|H|by your doctor, usually once daily.||
0284|035|H|   The dosage is based on your medical condition, response to||
0284|036|H|treatment, age, and other medications you may be taking. Be sure||
0284|037|H|to tell your doctor and pharmacist about all the products you use||
0284|038|H|(including prescription drugs, nonprescription drugs, and herbal||
0284|039|H|products).||
0284|040|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0284|041|H|using this medication unless your doctor or pharmacist says you||
0284|042|H|may do so safely. Grapefruit can increase the chance of side||
0284|043|H|effects with this medicine. Ask your doctor or pharmacist for||
0284|044|H|more details.||
0284|045|H|   If you also take certain other drugs to lower your cholesterol||
0284|046|H|(bile acid-binding resins such as cholestyramine or colestipol),||
0284|047|H|take atorvastatin at least 1 hour before or at least 4 hours||
0284|048|H|after taking these medications. These products can react with||
0284|049|H|atorvastatin, preventing its full absorption.||
0284|050|H|   Take this medication regularly in order to get the most||
0284|051|H|benefit from it. Remember to take it at the same time each day.||
0284|052|H|Keep taking this medication even if you feel well. Most people||
0284|053|H|with high cholesterol or triglycerides do not feel sick.||
0284|054|H|   It is very important to continue to follow your doctor's||
0284|055|H|advice about diet and exercise. It may take up to 4 weeks before||
0284|056|H|you get the full benefit of this drug.||
0284|057|B|||
0284|058|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0284|059|S|because your doctor has judged that the benefit to you is greater||
0284|060|S|than the risk of side effects. Many people using this medication||
0284|061|S|do not have serious side effects.||
0284|062|S|   A very small number of people taking atorvastatin may have||
0284|063|S|mild memory problems or confusion. If these rare effects occur,||
0284|064|S|talk to your doctor.||
0284|065|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
0284|066|S|doctor about the benefits and risks.||
0284|067|S|   This drug may rarely cause muscle problems (which can rarely||
0284|068|S|lead to very serious conditions called rhabdomyolysis and||
0284|069|S|autoimmune myopathy). Tell your doctor right away if you develop||
0284|070|S|any of these symptoms during treatment and if these symptoms last||
0284|071|S|after your doctor stops this drug: muscle||
0284|072|S|pain/tenderness/weakness (especially with fever or unusual||
0284|073|S|tiredness), signs of kidney problems (such as change in the||
0284|074|S|amount of urine).||
0284|075|S|   This medication may rarely cause liver problems. Tell your||
0284|076|S|doctor right away if you develop symptoms of liver problems,||
0284|077|S|including: nausea/vomiting that doesn't stop, yellowing||
0284|078|S|eyes/skin, dark urine, stomach/abdominal pain.||
0284|079|S|   A very serious allergic reaction to this drug is rare.||
0284|080|S|However, get medical help right away if you notice any symptoms||
0284|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0284|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0284|083|S|breathing.||
0284|084|S|   This is not a complete list of possible side effects. If you||
0284|085|S|notice other effects not listed above, contact your doctor or||
0284|086|S|pharmacist.||
0284|087|S|   In the US -||
0284|088|S|   Call your doctor for medical advice about side effects. You||
0284|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0284|090|S|www.fda.gov/medwatch.||
0284|091|S|   In Canada - Call your doctor for medical advice about side||
0284|092|S|effects. You may report side effects to Health Canada at||
0284|093|S|1-866-234-2345.||
0284|094|B|||
0284|095|P|PRECAUTIONS:  Before taking atorvastatin, tell your doctor or||
0284|096|P|pharmacist if you are allergic to it; or if you have any other||
0284|097|P|allergies. This product may contain inactive ingredients, which||
0284|098|P|can cause allergic reactions or other problems. Talk to your||
0284|099|P|pharmacist for more details.||
0284|100|P|   Before using this medication, tell your doctor or pharmacist||
0284|101|P|your medical history, especially of: liver disease, kidney||
0284|102|P|disease, alcohol use.||
0284|103|P|   Before having surgery, tell your doctor or dentist about all||
0284|104|P|the products you use (including prescription drugs,||
0284|105|P|nonprescription drugs, and herbal products).||
0284|106|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
0284|107|P|your risk for liver problems, especially when combined with||
0284|108|P|atorvastatin. Ask your doctor or pharmacist for more information.||
0284|109|P|   Older adults may be more sensitive to the side effects of this||
0284|110|P|drug, especially muscle problems.||
0284|111|P|   During pregnancy, this medication should be used only when||
0284|112|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0284|113|P|benefits with your doctor.||
0284|114|P|   It is unknown if this medication passes into breast milk.||
0284|115|P|Because of the possible risk to the infant, breastfeeding is not||
0284|116|P|recommended while using this medication. Consult your doctor||
0284|117|P|before breastfeeding.||
0284|118|B|||
0284|119|I|DRUG INTERACTIONS:  See also How to Use section.||
0284|120|I|   Drug interactions may change how your medications work or||
0284|121|I|increase your risk for serious side effects. This document does||
0284|122|I|not contain all possible drug interactions. Keep a list of all||
0284|123|I|the products you use (including prescription/nonprescription||
0284|124|I|drugs and herbal products) and share it with your doctor and||
0284|125|I|pharmacist. Do not start, stop, or change the dosage of any||
0284|126|I|medicines without your doctor's approval.||
0284|127|I|   Some products that may interact with this drug include:||
0284|128|I|daptomycin, gemfibrozil.||
0284|129|I|   Other medications can affect the removal of atorvastatin from||
0284|130|I|your body, which may affect how atorvastatin works. Examples||
0284|131|I|include glecaprevir plus pibrentasvir, telithromycin, among||
0284|132|I|others.||
0284|133|I|   Do not take any red yeast rice products while you are taking||
0284|134|I|atorvastatin because some red yeast rice products may also||
0284|135|I|contain a statin called lovastatin. Taking atorvastatin and red||
0284|136|I|yeast rice products together can increase your risk of serious||
0284|137|I|muscle and liver problems.||
0284|138|B|||
0284|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0284|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0284|141|O|poison control center right away. US residents can call||
0284|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0284|143|B|||
0284|144|N|NOTES:  Do not share this medication with others.||
0284|145|N|   Lab and/or medical tests (such as blood||
0284|146|N|cholesterol/triglyceride levels, liver function) should be done||
0284|147|N|while you are taking this medication. Keep all medical and lab||
0284|148|N|appointments. Consult your doctor for more details.||
0284|149|B|||
0284|150|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
0284|151|D|next dose at the regular time. Do not double the dose to catch||
0284|152|D|up.||
0284|153|B|||
0284|154|R|STORAGE:  Store at room temperature away from light and moisture.||
0284|155|R|Do not store in the bathroom. Keep all medications away from||
0284|156|R|children and pets.||
0284|157|R|   Do not flush medications down the toilet or pour them into a||
0284|158|R|drain unless instructed to do so. Properly discard this product||
0284|159|R|when it is expired or no longer needed. Consult your pharmacist||
0284|160|R|or local waste disposal company.||
0284|161|B|||
0284|162|A|Information last revised May 2024.||
0284|163|A|Copyright(c) 2025 First Databank, Inc.||
0284|164|B|||
0285|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0285|002|Z|does NOT have all possible information about this product. This||
0285|003|Z|information does not assure that this product is safe, effective,||
0285|004|Z|or appropriate for you. This information is not individual||
0285|005|Z|medical advice and does not substitute for the advice of your||
0285|006|Z|health care professional. Always ask your health care||
0285|007|Z|professional for complete information about this product and your||
0285|008|Z|specific health needs.||
0285|009|B|||
0285|010|T|BETAHISTINE - ORAL||
0285|011|F|(BAY-ta-HIS-teen)||
0285|012|B|||
0285|013|U|USES:  Betahistine is used to treat dizziness caused by a certain||
0285|014|U|disorder of the inner ear (Meniere's disease). Decreasing||
0285|015|U|dizziness helps to improve the ability to function and perform||
0285|016|U|tasks normally. This medication is classified as a histamine. It||
0285|017|U|may work by improving blood flow to the brain and affecting nerve||
0285|018|U|cells in the inner ear.||
0285|019|U|   This medication is not recommended for use in children.||
0285|020|B|||
0285|021|H|HOW TO USE:  This medication is taken by mouth with food as||
0285|022|H|directed by your doctor, usually 2 to 3 times daily.||
0285|023|H|   Dosage is based on your medical condition and response to||
0285|024|H|treatment.||
0285|025|H|   Use this medication regularly to get the most benefit from it.||
0285|026|H|To help you remember, take it at the same times each day.||
0285|027|H|   Tell your doctor if your condition lasts or gets worse.||
0285|028|B|||
0285|029|S|SIDE EFFECTS:  Stomach upset, nausea, and headache may occur.||
0285|030|S|This medication may also rarely cause drowsiness. If any of these||
0285|031|S|effects last or get worse, tell your doctor or pharmacist||
0285|032|S|promptly.||
0285|033|S|   Remember that this medication has been prescribed because your||
0285|034|S|doctor has judged that the benefit to you is greater than the||
0285|035|S|risk of side effects. Many people using this medication do not||
0285|036|S|have serious side effects.||
0285|037|S|   A very serious allergic reaction to this drug is rare.||
0285|038|S|However, get medical help right away if you notice any symptoms||
0285|039|S|of a serious allergic reaction, including: rash, itching/swelling||
0285|040|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0285|041|S|breathing.||
0285|042|S|   This is not a complete list of possible side effects. If you||
0285|043|S|notice other effects not listed above, contact your doctor or||
0285|044|S|pharmacist.||
0285|045|S|   In the US -||
0285|046|S|   Call your doctor for medical advice about side effects. You||
0285|047|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0285|048|S|www.fda.gov/medwatch.||
0285|049|S|   In Canada - Call your doctor for medical advice about side||
0285|050|S|effects. You may report side effects to Health Canada at||
0285|051|S|1-866-234-2345.||
0285|052|B|||
0285|053|P|PRECAUTIONS:  Before taking betahistine, tell your doctor or||
0285|054|P|pharmacist if you are allergic to it; or if you have any other||
0285|055|P|allergies. This product may contain inactive ingredients, which||
0285|056|P|can cause allergic reactions or other problems. Talk to your||
0285|057|P|pharmacist for more details.||
0285|058|P|   Before using this medication, tell your doctor or pharmacist||
0285|059|P|your medical history, especially of: breathing problems (such as||
0285|060|P|asthma, chronic obstructive pulmonary disease-COPD), a certain||
0285|061|P|adrenal gland tumor (pheochromocytoma), stomach/intestinal ulcer.||
0285|062|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
0285|063|P|can make you more drowsy. Do not drive, use machinery, or do||
0285|064|P|anything that needs alertness until you can do it safely. Limit||
0285|065|P|alcoholic beverages. Talk to your doctor if you are using||
0285|066|P|marijuana (cannabis).||
0285|067|P|   During pregnancy, this medication should be used only when||
0285|068|P|clearly needed. Discuss the risks and benefits with your doctor.||
0285|069|P|   It is unknown if this drug passes into breast milk. Consult||
0285|070|P|your doctor before breastfeeding.||
0285|071|B|||
0285|072|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0285|073|I|medications work or increase your risk for serious side effects.||
0285|074|I|This document does not contain all possible drug interactions.||
0285|075|I|Keep a list of all the products you use (including||
0285|076|I|prescription/nonprescription drugs and herbal products) and share||
0285|077|I|it with your doctor and pharmacist. Do not start, stop, or change||
0285|078|I|the dosage of any medicines without your doctor's approval.||
0285|079|I|   Some products that may interact with this drug include:||
0285|080|I|antihistamines (such as diphenhydramine, meclizine).||
0285|081|I|   Check the labels on all your medicines (such as cough-and-cold||
0285|082|I|products) because they may contain ingredients that may cause||
0285|083|I|drowsiness. Ask your pharmacist about using those products||
0285|084|I|safely.||
0285|085|B|||
0285|086|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0285|087|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0285|088|O|poison control center right away. US residents can call||
0285|089|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0285|090|O|Symptoms of overdose may include: nausea, dry mouth, drowsiness.||
0285|091|B|||
0285|092|N|NOTES:  Do not share this medication with others.||
0285|093|B|||
0285|094|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0285|095|D|remember. If it is near the time of the next dose, skip the||
0285|096|D|missed dose. Take your next dose at the regular time. Do not||
0285|097|D|double the dose to catch up.||
0285|098|B|||
0285|099|R|STORAGE:  Store at room temperature away from light and moisture.||
0285|100|R|Do not store in the bathroom. Keep all medications away from||
0285|101|R|children and pets.||
0285|102|R|   Do not flush medications down the toilet or pour them into a||
0285|103|R|drain unless instructed to do so. Properly discard this product||
0285|104|R|when it is expired or no longer needed. Consult your pharmacist||
0285|105|R|or local waste disposal company.||
0285|106|B|||
0285|107|A|Information last revised August 2024.||
0285|108|A|Copyright(c) 2025 First Databank, Inc.||
0285|109|B|||
0290|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0290|002|Z|does NOT have all possible information about this product. This||
0290|003|Z|information does not assure that this product is safe, effective,||
0290|004|Z|or appropriate for you. This information is not individual||
0290|005|Z|medical advice and does not substitute for the advice of your||
0290|006|Z|health care professional. Always ask your health care||
0290|007|Z|professional for complete information about this product and your||
0290|008|Z|specific health needs.||
0290|009|B|||
0290|010|T|HYALURONATE - INJECTION||
0290|011|F|(HYE-al-ure-ON-ate)||
0290|012|B|||
0290|013|C|COMMON BRAND NAME(S): Hyalgan, Synvisc||
0290|014|B|||
0290|015|U|USES:  This medication is used to treat knee pain in patients||
0290|016|U|with joint inflammation (osteoarthritis). It is usually used in||
0290|017|U|patients who have not responded to other treatments such as||
0290|018|U|acetaminophen, exercise, or physical therapy. Hyaluronate (also||
0290|019|U|known as hyaluronan) is similar to a substance that occurs||
0290|020|U|naturally in the joints. It may work by acting as a lubricant and||
0290|021|U|shock absorber in the joint, helping the knee to move smoothly,||
0290|022|U|thereby lessening pain.||
0290|023|B|||
0290|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0290|025|H|from your health care professional before you start using||
0290|026|H|hyaluronate and each time you get a refill. If you have any||
0290|027|H|questions, ask your doctor or pharmacist.||
0290|028|H|   This medication is given by injection into the affected joint||
0290|029|H|by a health care professional. It is given as directed by your||
0290|030|H|doctor, usually once a week. The dosage is based on your medical||
0290|031|H|condition and response to treatment. Extra fluid may need to be||
0290|032|H|removed from the joint before the medication is injected.||
0290|033|H|   It is important to have this medication injected on schedule.||
0290|034|H|It may take up to 3 injections before the full benefits of this||
0290|035|H|medication occur.||
0290|036|H|   After receiving an injection of hyaluronate, you should avoid||
0290|037|H|any activities that put stress on your knee (such as jogging,||
0290|038|H|tennis, heavy lifting, standing on your feet for more than an||
0290|039|H|hour) for 48 hours. Also, after the injection, you may experience||
0290|040|H|increased pain and swelling in the knee at first. Tell your||
0290|041|H|doctor if the pain or swelling lasts or gets worse.||
0290|042|B|||
0290|043|S|SIDE EFFECTS:  See also How to Use section.||
0290|044|S|   Pain, swelling, redness/warmth/bruising at the injection site,||
0290|045|S|or headache may occur. If any of these effects last or get worse,||
0290|046|S|tell your doctor or pharmacist promptly.||
0290|047|S|   Remember that this medication has been prescribed because your||
0290|048|S|doctor has judged that the benefit to you is greater than the||
0290|049|S|risk of side effects. Many people using this medication do not||
0290|050|S|have serious side effects.||
0290|051|S|   Tell your doctor right away if you have any serious side||
0290|052|S|effects, including: back pain, severe headache, fast/pounding||
0290|053|S|heartbeat, fever, tingling skin.||
0290|054|S|   A very serious allergic reaction to this drug is rare.||
0290|055|S|However, get medical help right away if you notice any symptoms||
0290|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0290|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0290|058|S|breathing.||
0290|059|S|   This is not a complete list of possible side effects. If you||
0290|060|S|notice other effects not listed above, contact your doctor or||
0290|061|S|pharmacist.||
0290|062|S|   In the US -||
0290|063|S|   Call your doctor for medical advice about side effects. You||
0290|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0290|065|S|www.fda.gov/medwatch.||
0290|066|S|   In Canada - Call your doctor for medical advice about side||
0290|067|S|effects. You may report side effects to Health Canada at||
0290|068|S|1-866-234-2345.||
0290|069|B|||
0290|070|P|PRECAUTIONS:  Before using hyaluronate, tell your doctor or||
0290|071|P|pharmacist if you are allergic to it; or if you have any other||
0290|072|P|allergies. For some brands, also tell your doctor or pharmacist||
0290|073|P|if you are allergic to bird proteins, feathers, or egg products.||
0290|074|P|This product may contain inactive ingredients (such as latex||
0290|075|P|found in the rubber syringe cap of some brands), which can cause||
0290|076|P|allergic reactions or other problems. Talk to your pharmacist for||
0290|077|P|more details.||
0290|078|P|   Before using this medication, tell your doctor or pharmacist||
0290|079|P|your medical history, especially of: knee joint infections, skin||
0290|080|P|infections/problems in the area around the injection site,||
0290|081|P|circulation problems in the legs.||
0290|082|P|   Before having surgery, tell your doctor or dentist about all||
0290|083|P|the products you use (including prescription drugs,||
0290|084|P|nonprescription drugs, and herbal products).||
0290|085|P|   During pregnancy, this medication should be used only when||
0290|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
0290|087|P|   It is unknown if this drug passes into breast milk. Consult||
0290|088|P|your doctor before breastfeeding.||
0290|089|B|||
0290|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0290|091|I|medications work or increase your risk for serious side effects.||
0290|092|I|This document does not contain all possible drug interactions.||
0290|093|I|Keep a list of all the products you use (including||
0290|094|I|prescription/nonprescription drugs and herbal products) and share||
0290|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
0290|096|I|the dosage of any medicines without your doctor's approval.||
0290|097|B|||
0290|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0290|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0290|100|O|poison control center right away. US residents can call||
0290|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0290|102|B|||
0290|103|N|NOTES:  Non-drug treatments for osteoarthritis include||
0290|104|N|exercising, doing physical therapy, losing weight, having extra||
0290|105|N|fluid removed from the knee, and avoiding activities that cause||
0290|106|N|pain in your knee.||
0290|107|B|||
0290|108|D|MISSED DOSE:  It is important to get each dose of this medication||
0290|109|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0290|110|D|right away for a new dosing schedule.||
0290|111|B|||
0290|112|R|STORAGE:  Not applicable. This medication is given in a clinic||
0290|113|R|and will not be stored at home.||
0290|114|B|||
0290|115|A|Information last revised October 2024.||
0290|116|A|Copyright(c) 2025 First Databank, Inc.||
0290|117|B|||
0295|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0295|002|Z|does NOT have all possible information about this product. This||
0295|003|Z|information does not assure that this product is safe, effective,||
0295|004|Z|or appropriate for you. This information is not individual||
0295|005|Z|medical advice and does not substitute for the advice of your||
0295|006|Z|health care professional. Always ask your health care||
0295|007|Z|professional for complete information about this product and your||
0295|008|Z|specific health needs.||
0295|009|B|||
0295|010|T|AMOXICILLIN SUSPENSION - ORAL||
0295|011|F|(a-MOX-i-SIL-in)||
0295|012|B|||
0295|013|C|COMMON BRAND NAME(S): Amoxil||
0295|014|B|||
0295|015|U|USES:  Amoxicillin is used to treat a wide variety of bacterial||
0295|016|U|infections. This medication is a penicillin-type antibiotic. It||
0295|017|U|works by stopping the growth of bacteria.||
0295|018|U|   This antibiotic treats only bacterial infections. It will not||
0295|019|U|work for viral infections (such as common cold, flu). Using any||
0295|020|U|antibiotic when it is not needed can cause it to not work for||
0295|021|U|future infections.||
0295|022|U|   Amoxicillin is also used with other medications to treat||
0295|023|U|stomach/intestinal ulcers caused by the bacteria H. pylori and to||
0295|024|U|prevent the ulcers from returning.||
0295|025|B|||
0295|026|H|HOW TO USE:  Shake the bottle well before each dose. Carefully||
0295|027|H|measure the dose using a special measuring device/spoon. Do not||
0295|028|H|use a household spoon because you may not get the correct dose.||
0295|029|H|Take this medication by mouth with or without food as directed by||
0295|030|H|your doctor, usually every 8 or 12 hours. The dosage is based on||
0295|031|H|your medical condition and response to treatment.||
0295|032|H|   You may add the measured dose to formula, milk, juice, water,||
0295|033|H|or ginger ale just before use. Drink all of the mixture to get||
0295|034|H|the full dose. Do not mix ahead of time for future use.||
0295|035|H|   Drink plenty of fluids while using this medication unless your||
0295|036|H|doctor tells you otherwise.||
0295|037|H|   For the best effect, take this antibiotic at evenly spaced||
0295|038|H|times. To help you remember, take this medication at the same||
0295|039|H|time(s) every day.||
0295|040|H|   Continue to take this medication until the full prescribed||
0295|041|H|amount is finished, even if symptoms disappear after a few days.||
0295|042|H|Stopping the medication too early may result in a return of the||
0295|043|H|infection.||
0295|044|H|   Tell your doctor if your condition lasts or gets worse.||
0295|045|B|||
0295|046|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. If any of||
0295|047|S|these effects last or get worse, tell your doctor or pharmacist||
0295|048|S|promptly.||
0295|049|S|   This medicine may cause temporary staining of the teeth.||
0295|050|S|Proper brushing will usually remove any stains and prevent them||
0295|051|S|from occurring.||
0295|052|S|   Remember that this medication has been prescribed because your||
0295|053|S|doctor has judged that the benefit to you is greater than the||
0295|054|S|risk of side effects. Many people using this medication do not||
0295|055|S|have serious side effects.||
0295|056|S|   Use of this medication for prolonged or repeated periods may||
0295|057|S|result in oral thrush or a new vaginal yeast infection (oral or||
0295|058|S|vaginal fungal infection). Contact your doctor if you notice||
0295|059|S|white patches in your mouth, a change in vaginal discharge or||
0295|060|S|other new symptoms.||
0295|061|S|   Tell your doctor right away if you have any serious side||
0295|062|S|effects, including: signs of liver disease (such as||
0295|063|S|nausea/vomiting that doesn't stop, loss of appetite,||
0295|064|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
0295|065|S|bruising or bleeding.||
0295|066|S|   This medication may rarely cause a severe intestinal condition||
0295|067|S|due to a bacteria called C. difficile. This condition may occur||
0295|068|S|during treatment or weeks to months after treatment has stopped.||
0295|069|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0295|070|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0295|071|S|stool.||
0295|072|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0295|073|S|products because they may make symptoms worse.||
0295|074|S|   A very serious allergic reaction to this drug is rare.||
0295|075|S|However, get medical help right away if you notice any symptoms||
0295|076|S|of a serious allergic reaction, including: fever that doesn't go||
0295|077|S|away, new or worsening lymph node swelling, rash,||
0295|078|S|itching/swelling (especially of the face/tongue/throat), severe||
0295|079|S|dizziness, trouble breathing.||
0295|080|S|   Amoxicillin can commonly cause a mild rash that is usually not||
0295|081|S|serious. However, you may not be able to tell it apart from a||
0295|082|S|rare rash that could be a sign of a severe allergic reaction. Get||
0295|083|S|medical help right away if you develop any rash.||
0295|084|S|   This is not a complete list of possible side effects. If you||
0295|085|S|notice other effects not listed above, contact your doctor or||
0295|086|S|pharmacist.||
0295|087|S|   In the US -||
0295|088|S|   Call your doctor for medical advice about side effects. You||
0295|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0295|090|S|www.fda.gov/medwatch.||
0295|091|S|   In Canada - Call your doctor for medical advice about side||
0295|092|S|effects. You may report side effects to Health Canada at||
0295|093|S|1-866-234-2345.||
0295|094|B|||
0295|095|P|PRECAUTIONS:  Before taking amoxicillin, tell your doctor or||
0295|096|P|pharmacist if you are allergic to it; or to penicillin or||
0295|097|P|cephalosporin antibiotics; or if you have any other allergies.||
0295|098|P|This product may contain inactive ingredients, which can cause||
0295|099|P|allergic reactions or other problems. Talk to your pharmacist for||
0295|100|P|more details.||
0295|101|P|   Before using this medication, tell your doctor or pharmacist||
0295|102|P|your medical history, especially of: kidney disease, a certain||
0295|103|P|type of viral infection (infectious mononucleosis).||
0295|104|P|   Amoxicillin suspension may contain sugar. Caution is advised||
0295|105|P|if you have diabetes or any other condition that requires you to||
0295|106|P|limit/avoid sugar in your diet. Ask your doctor or pharmacist||
0295|107|P|about using this product safely.||
0295|108|P|   Amoxicillin may cause live bacterial vaccines (such as typhoid||
0295|109|P|vaccine) to not work well. Tell your health care professional||
0295|110|P|that you are using amoxicillin before having any||
0295|111|P|immunizations/vaccinations.||
0295|112|P|   Before having surgery, tell your doctor or dentist about all||
0295|113|P|the products you use (including prescription drugs,||
0295|114|P|nonprescription drugs, and herbal products).||
0295|115|P|   During pregnancy, this medication should be used only when||
0295|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
0295|117|P|   Amoxicillin passes into breast milk. Consult your doctor||
0295|118|P|before breastfeeding.||
0295|119|B|||
0295|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0295|121|I|medications work or increase your risk for serious side effects.||
0295|122|I|This document does not contain all possible drug interactions.||
0295|123|I|Keep a list of all the products you use (including||
0295|124|I|prescription/nonprescription drugs and herbal products) and share||
0295|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
0295|126|I|the dosage of any medicines without your doctor's approval.||
0295|127|I|   A product that may interact with this drug is: methotrexate.||
0295|128|I|   This medication may interfere with certain lab tests (such as||
0295|129|I|certain diabetic urine tests), possibly causing false test||
0295|130|I|results. Make sure lab personnel and all your doctors know you||
0295|131|I|use this drug.||
0295|132|B|||
0295|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0295|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0295|135|O|poison control center right away. US residents can call||
0295|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0295|137|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
0295|138|O|severe vomiting, a severe decrease in the amount of urine, or||
0295|139|O|seizures.||
0295|140|B|||
0295|141|N|NOTES:  Do not share this medication with others.||
0295|142|N|   This medication has been prescribed for your current condition||
0295|143|N|only. Do not use it later for another infection unless your||
0295|144|N|doctor tells you to.||
0295|145|N|   With prolonged treatment, lab and/or medical tests (such as||
0295|146|N|kidney/liver function, complete blood counts) may be done while||
0295|147|N|you are taking this medication. Keep all medical and lab||
0295|148|N|appointments. Consult your doctor for more details.||
0295|149|B|||
0295|150|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0295|151|D|If it is near the time of the next dose, skip the missed dose.||
0295|152|D|Use your next dose at the regular time. Do not double the dose to||
0295|153|D|catch up.||
0295|154|B|||
0295|155|R|STORAGE:  Refrigeration may improve the taste of this medicine.||
0295|156|R|Certain brands of this medicine may expire earlier when stored at||
0295|157|R|room temperature than when refrigerated. Check the bottle or ask||
0295|158|R|your pharmacist to see if (and for how long) you can store this||
0295|159|R|medicine at room temperature. Keep all medications away from||
0295|160|R|children and pets.||
0295|161|R|   Discard any unused portion after 14 days since the drug loses||
0295|162|R|potency after that time.||
0295|163|R|   Do not flush medications down the toilet or pour them into a||
0295|164|R|drain unless instructed to do so. Properly discard this product||
0295|165|R|when it is expired or no longer needed. Consult your pharmacist||
0295|166|R|or local waste disposal company.||
0295|167|B|||
0295|168|A|Information last revised October 2024.||
0295|169|A|Copyright(c) 2025 First Databank, Inc.||
0295|170|B|||
0296|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0296|002|Z|does NOT have all possible information about this product. This||
0296|003|Z|information does not assure that this product is safe, effective,||
0296|004|Z|or appropriate for you. This information is not individual||
0296|005|Z|medical advice and does not substitute for the advice of your||
0296|006|Z|health care professional. Always ask your health care||
0296|007|Z|professional for complete information about this product and your||
0296|008|Z|specific health needs.||
0296|009|B|||
0296|010|T|DOLASETRON - ORAL||
0296|011|F|(doe-LAS-e-tron)||
0296|012|B|||
0296|013|C|COMMON BRAND NAME(S): Anzemet||
0296|014|B|||
0296|015|U|USES:  This medication is used to prevent nausea and vomiting||
0296|016|U|caused by cancer drug treatment (chemotherapy). Dolasetron works||
0296|017|U|by blocking one of the body's natural substances (serotonin) that||
0296|018|U|causes vomiting.||
0296|019|B|||
0296|020|H|HOW TO USE:  Take this medication by mouth with or without food||
0296|021|H|as directed by your doctor, usually within 1 hour before the||
0296|022|H|start of chemotherapy.||
0296|023|H|   Children's dosage is based on age and weight. Take this||
0296|024|H|medication exactly as prescribed to get the most benefit from it.||
0296|025|H|Do not increase your dose or use this drug more often or for||
0296|026|H|longer than prescribed.||
0296|027|H|   Tell your doctor if you vomit or feel nauseated.||
0296|028|B|||
0296|029|S|SIDE EFFECTS:  Headache, diarrhea, tiredness, or dizziness may||
0296|030|S|occur. If any of these effects last or get worse, tell your||
0296|031|S|doctor or pharmacist promptly.||
0296|032|S|   Remember that this medication has been prescribed because your||
0296|033|S|doctor has judged that the benefit to you is greater than the||
0296|034|S|risk of side effects. Many people using this medication do not||
0296|035|S|have serious side effects.||
0296|036|S|   Get medical help right away if you have any very serious side||
0296|037|S|effects, including: severe dizziness, fainting,||
0296|038|S|slow/fast/irregular heartbeat.||
0296|039|S|   This medication may increase serotonin and rarely cause a very||
0296|040|S|serious condition called serotonin syndrome/toxicity. The risk||
0296|041|S|increases if you are also taking other drugs that increase||
0296|042|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0296|043|S|take (see Drug Interactions section). Get medical help right away||
0296|044|S|if you develop some of the following symptoms: fast heartbeat,||
0296|045|S|hallucinations, loss of coordination, severe dizziness, severe||
0296|046|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0296|047|S|unusual agitation/restlessness.||
0296|048|S|   A very serious allergic reaction to this drug is rare.||
0296|049|S|However, get medical help right away if you notice any symptoms||
0296|050|S|of a serious allergic reaction, including: rash, itching/swelling||
0296|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0296|052|S|breathing.||
0296|053|S|   This is not a complete list of possible side effects. If you||
0296|054|S|notice other effects not listed above, contact your doctor or||
0296|055|S|pharmacist.||
0296|056|S|   In the US -||
0296|057|S|   Call your doctor for medical advice about side effects. You||
0296|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0296|059|S|www.fda.gov/medwatch.||
0296|060|S|   In Canada - Call your doctor for medical advice about side||
0296|061|S|effects. You may report side effects to Health Canada at||
0296|062|S|1-866-234-2345.||
0296|063|B|||
0296|064|P|PRECAUTIONS:  Before taking dolasetron, tell your doctor or||
0296|065|P|pharmacist if you are allergic to it; or to other anti-nausea||
0296|066|P|serotonin blockers (such as granisetron, ondansetron); or if you||
0296|067|P|have any other allergies. This product may contain inactive||
0296|068|P|ingredients, which can cause allergic reactions or other||
0296|069|P|problems. Talk to your pharmacist for more details.||
0296|070|P|   Before using this medication, tell your doctor or pharmacist||
0296|071|P|your medical history, especially of: kidney disease.||
0296|072|P|   Dolasetron may cause a condition that affects the heart rhythm||
0296|073|P|(QT prolongation). QT prolongation can rarely cause serious||
0296|074|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0296|075|P|as severe dizziness, fainting) that need medical attention right||
0296|076|P|away.||
0296|077|P|   The risk of QT prolongation may be increased if you have||
0296|078|P|certain medical conditions or are taking other drugs that may||
0296|079|P|cause QT prolongation. Before using dolasetron, tell your doctor||
0296|080|P|or pharmacist of all the drugs you take and if you have any of||
0296|081|P|the following conditions: certain heart problems (heart failure,||
0296|082|P|slow heartbeat, QT prolongation in the EKG), family history of||
0296|083|P|certain heart problems (QT prolongation in the EKG, sudden||
0296|084|P|cardiac death).||
0296|085|P|   Low levels of potassium or magnesium in the blood may also||
0296|086|P|increase your risk of QT prolongation. This risk may increase if||
0296|087|P|you use certain drugs (such as diuretics/"water pills") or if you||
0296|088|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0296|089|P|Talk to your doctor about using dolasetron safely.||
0296|090|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0296|091|P|can make you more dizzy. Do not drive, use machinery, or do||
0296|092|P|anything that needs alertness until you can do it safely. Limit||
0296|093|P|alcoholic beverages. Talk to your doctor if you are using||
0296|094|P|marijuana (cannabis).||
0296|095|P|   Before having surgery, tell your doctor or dentist about all||
0296|096|P|the products you use (including prescription drugs,||
0296|097|P|nonprescription drugs, and herbal products).||
0296|098|P|   Older adults may be more sensitive to the side effects of this||
0296|099|P|drug, especially irregular heartbeat and QT prolongation (see||
0296|100|P|above).||
0296|101|P|   During pregnancy, this medication should be used only when||
0296|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0296|103|P|   It is unknown if this medication passes into breast milk.||
0296|104|P|Consult your doctor before breastfeeding.||
0296|105|B|||
0296|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0296|107|I|medications work or increase your risk for serious side effects.||
0296|108|I|This document does not contain all possible drug interactions.||
0296|109|I|Keep a list of all the products you use (including||
0296|110|I|prescription/nonprescription drugs and herbal products) and share||
0296|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0296|112|I|the dosage of any medicines without your doctor's approval.||
0296|113|I|   Some products that may interact with this drug are:||
0296|114|I|apomorphine, ziprasidone.||
0296|115|I|   The risk of serotonin syndrome/toxicity increases if you are||
0296|116|I|also taking other drugs that increase serotonin. Examples include||
0296|117|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0296|118|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0296|119|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0296|120|I|serotonin syndrome/toxicity may be more likely when you start or||
0296|121|I|increase the dose of these drugs.||
0296|122|B|||
0296|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0296|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0296|125|O|poison control center right away. US residents can call||
0296|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0296|127|B|||
0296|128|N|NOTES:  Do not share this medication with others.||
0296|129|N|   Lab and/or medical tests (such as EKG, blood mineral levels)||
0296|130|N|may be done while you are taking this medication. Keep all||
0296|131|N|medical and lab appointments. Consult your doctor for more||
0296|132|N|details.||
0296|133|B|||
0296|134|D|MISSED DOSE:  It is important to take each dose of this||
0296|135|D|medication as scheduled. If you miss a dose, ask your doctor or||
0296|136|D|pharmacist right away for a new dosing schedule. Do not double||
0296|137|D|the dose to catch up.||
0296|138|B|||
0296|139|R|STORAGE:  Store at room temperature away from light and moisture.||
0296|140|R|Do not store in the bathroom. Keep all medications away from||
0296|141|R|children and pets.||
0296|142|R|   Do not flush medications down the toilet or pour them into a||
0296|143|R|drain unless instructed to do so. Properly discard this product||
0296|144|R|when it is expired or no longer needed. Consult your pharmacist||
0296|145|R|or local waste disposal company.||
0296|146|B|||
0296|147|A|Information last revised August 2024.||
0296|148|A|Copyright(c) 2025 First Databank, Inc.||
0296|149|B|||
0297|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0297|002|Z|does NOT have all possible information about this product. This||
0297|003|Z|information does not assure that this product is safe, effective,||
0297|004|Z|or appropriate for you. This information is not individual||
0297|005|Z|medical advice and does not substitute for the advice of your||
0297|006|Z|health care professional. Always ask your health care||
0297|007|Z|professional for complete information about this product and your||
0297|008|Z|specific health needs.||
0297|009|B|||
0297|010|T|SILDENAFIL - ORAL||
0297|011|F|(sil-DEN-a-fil)||
0297|012|B|||
0297|013|C|COMMON BRAND NAME(S): Viagra||
0297|014|B|||
0297|015|U|USES:  Sildenafil is used to treat male sexual function problems||
0297|016|U|(impotence or erectile dysfunction-ED). In combination with||
0297|017|U|sexual stimulation, sildenafil works by increasing blood flow to||
0297|018|U|the penis to help a person get and keep an erection.||
0297|019|U|   This drug does not protect against sexually transmitted||
0297|020|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
0297|021|U|an effective barrier method (latex or polyurethane condom/dental||
0297|022|U|dams) during sexual activity will help to decrease your risk of||
0297|023|U|infection.||
0297|024|B|||
0297|025|V|OTHER USES:  This section contains uses of this drug that are not||
0297|026|V|listed in the approved professional labeling for the drug but||
0297|027|V|that may be prescribed by your health care professional. Use this||
0297|028|V|drug for a condition that is listed in this section only if it||
0297|029|V|has been so prescribed by your health care professional.||
0297|030|V|   Sildenafil is also available in other brands and strengths for||
0297|031|V|high blood pressure in the lungs (pulmonary hypertension).||
0297|032|B|||
0297|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0297|034|H|from your pharmacist before you start taking sildenafil and each||
0297|035|H|time you get a refill. If you have any questions, ask your doctor||
0297|036|H|or pharmacist.||
0297|037|H|   To treat erectile dysfunction-ED, take this drug by mouth as||
0297|038|H|directed by your doctor, usually as needed. Take sildenafil at||
0297|039|H|least 30 minutes, but no more than 4 hours, before sexual||
0297|040|H|activity (1 hour before works best). This medication may take||
0297|041|H|longer to start working if you take it with a high-fat meal. Do||
0297|042|H|not take more than once daily as needed.||
0297|043|H|   The dosage is based on your medical condition, response to||
0297|044|H|treatment, and other medications you may be taking. Be sure to||
0297|045|H|tell your doctor and pharmacist about all the products you use||
0297|046|H|(including prescription drugs, nonprescription drugs, and herbal||
0297|047|H|products).||
0297|048|H|   Tell your doctor if your condition does not get better.||
0297|049|B|||
0297|050|S|SIDE EFFECTS:  Dizziness, headache, flushing, or stomach upset||
0297|051|S|may occur. Vision changes such as increased sensitivity to light,||
0297|052|S|blurred vision, or trouble telling blue and green colors apart||
0297|053|S|may also occur. If any of these effects last or get worse, tell||
0297|054|S|your doctor or pharmacist promptly.||
0297|055|S|   To reduce the risk of dizziness and lightheadedness, get up||
0297|056|S|slowly when rising from a sitting or lying position.||
0297|057|S|   Remember that this medication has been prescribed because your||
0297|058|S|doctor has judged that the benefit to you is greater than the||
0297|059|S|risk of side effects. Many people using this medication do not||
0297|060|S|have serious side effects.||
0297|061|S|   Sexual activity may put extra strain on your heart, especially||
0297|062|S|if you have heart problems. If you have heart problems and||
0297|063|S|experience any of these serious side effects while having sex,||
0297|064|S|stop and get medical help right away: severe dizziness, fainting,||
0297|065|S|chest/jaw/left arm pain, nausea.||
0297|066|S|   Rarely, sudden decreased vision, or even permanent blindness,||
0297|067|S|may occur in one or both eyes (NAION). If this serious problem||
0297|068|S|occurs, stop taking sildenafil and get medical help right away.||
0297|069|S|You have a slightly greater chance of developing NAION if you||
0297|070|S|have heart disease, diabetes, high cholesterol, certain other eye||
0297|071|S|problems ("crowded disk"), high blood pressure, if you are over||
0297|072|S|50, or if you smoke.||
0297|073|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
0297|074|S|ringing in the ears and dizziness, may occur. Stop taking||
0297|075|S|sildenafil and get medical help right away if these effects||
0297|076|S|occur.||
0297|077|S|   Rarely, males may have a painful or prolonged erection lasting||
0297|078|S|4 or more hours. If this occurs, stop using this drug and get||
0297|079|S|medical help right away, or permanent problems could occur.||
0297|080|S|   A very serious allergic reaction to this drug is rare.||
0297|081|S|However, get medical help right away if you notice any symptoms||
0297|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0297|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0297|084|S|breathing.||
0297|085|S|   This is not a complete list of possible side effects. If you||
0297|086|S|notice other effects not listed above, contact your doctor or||
0297|087|S|pharmacist.||
0297|088|S|   In the US -||
0297|089|S|   Call your doctor for medical advice about side effects. You||
0297|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0297|091|S|www.fda.gov/medwatch.||
0297|092|S|   In Canada - Call your doctor for medical advice about side||
0297|093|S|effects. You may report side effects to Health Canada at||
0297|094|S|1-866-234-2345.||
0297|095|B|||
0297|096|P|PRECAUTIONS:  Before taking sildenafil, tell your doctor or||
0297|097|P|pharmacist if you are allergic to it; or if you have any other||
0297|098|P|allergies. This product may contain inactive ingredients, which||
0297|099|P|can cause allergic reactions or other problems. Talk to your||
0297|100|P|pharmacist for more details.||
0297|101|P|   Before using this medication, tell your doctor or pharmacist||
0297|102|P|your medical history, especially of: heart problems (such as||
0297|103|P|heart attack or life-threatening irregular heartbeat in the past||
0297|104|P|6 months, chest pain/angina, heart failure), stroke in the past 6||
0297|105|P|months, kidney disease, liver disease, high or low blood||
0297|106|P|pressure, dehydration, penis conditions (such as angulation,||
0297|107|P|fibrosis/scarring, Peyronie's disease), history of||
0297|108|P|painful/prolonged erection (priapism), conditions that may||
0297|109|P|increase the risk of priapism (such as sickle cell anemia,||
0297|110|P|leukemia, multiple myeloma), eye problems (such as retinitis||
0297|111|P|pigmentosa, sudden decreased vision, NAION).||
0297|112|P|   This drug may make you dizzy or cause vision problems. Alcohol||
0297|113|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
0297|114|P|use machinery, or do anything that needs alertness or clear||
0297|115|P|vision until you can do it safely. Limit alcoholic beverages.||
0297|116|P|Talk to your doctor if you are using marijuana (cannabis).||
0297|117|P|   Before having surgery, tell your doctor or dentist about all||
0297|118|P|the products you use (including prescription drugs,||
0297|119|P|nonprescription drugs, and herbal products).||
0297|120|P|   During pregnancy, sildenafil should be used only when clearly||
0297|121|P|needed. Since high blood pressure in the lungs is a serious||
0297|122|P|condition that can harm both a pregnant woman and her unborn||
0297|123|P|baby, do not stop taking this medication unless directed by your||
0297|124|P|doctor. If you are planning pregnancy, become pregnant, or think||
0297|125|P|you may be pregnant, discuss with your doctor right away the||
0297|126|P|benefits and risks of using this medication during pregnancy.||
0297|127|P|   This medication passes into breast milk. Consult your doctor||
0297|128|P|before breastfeeding.||
0297|129|B|||
0297|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0297|131|I|medications work or increase your risk for serious side effects.||
0297|132|I|This document does not contain all possible drug interactions.||
0297|133|I|Keep a list of all the products you use (including||
0297|134|I|prescription/nonprescription drugs and herbal products) and share||
0297|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
0297|136|I|the dosage of any medicines without your doctor's approval.||
0297|137|I|   Some products that may interact with this drug are: riociguat,||
0297|138|I|vericiguat.||
0297|139|I|   Sildenafil can cause a serious drop in your blood pressure||
0297|140|I|when used with nitrates. A serious drop in blood pressure can||
0297|141|I|lead to dizziness, fainting, and rarely heart attack or stroke.||
0297|142|I|Do not use sildenafil with any of the following: certain drugs||
0297|143|I|used to treat chest pain/angina (nitrates such as nitroglycerin,||
0297|144|I|isosorbide), recreational drugs called "poppers" containing amyl||
0297|145|I|or butyl nitrite.||
0297|146|I|   If you are also taking an alpha blocker medication (such as||
0297|147|I|doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high||
0297|148|I|blood pressure, your blood pressure may get too low which can||
0297|149|I|lead to dizziness or fainting. Your doctor may start treatment||
0297|150|I|with a lower dose of sildenafil to minimize your risk of low||
0297|151|I|blood pressure.||
0297|152|I|   Other medications can affect the removal of sildenafil from||
0297|153|I|your body, which may affect how sildenafil works. Examples||
0297|154|I|include azole antifungals (such as itraconazole, ketoconazole),||
0297|155|I|macrolide antibiotics (such as clarithromycin, erythromycin),||
0297|156|I|mifepristone, rifampin, ritonavir, among others.||
0297|157|I|   Do not take this medication with any other product that||
0297|158|I|contains sildenafil or other similar medications for erectile||
0297|159|I|dysfunction-ED or pulmonary hypertension (such as tadalafil,||
0297|160|I|vardenafil).||
0297|161|B|||
0297|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0297|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0297|164|O|poison control center right away. US residents can call||
0297|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0297|166|O|Symptoms of overdose may include: severe dizziness, fainting,||
0297|167|O|painful/prolonged erection.||
0297|168|B|||
0297|169|N|NOTES:  Do not share this medication with others.||
0297|170|B|||
0297|171|D|MISSED DOSE:  Not applicable.||
0297|172|B|||
0297|173|R|STORAGE:  Store at room temperature away from light and moisture.||
0297|174|R|Do not store in the bathroom. Keep all medications away from||
0297|175|R|children and pets.||
0297|176|R|   Do not flush medications down the toilet or pour them into a||
0297|177|R|drain unless instructed to do so. Properly discard this product||
0297|178|R|when it is expired or no longer needed. Consult your pharmacist||
0297|179|R|or local waste disposal company.||
0297|180|B|||
0297|181|A|Information last revised October 2025.||
0297|182|A|Copyright(c) 2025 First Databank, Inc.||
0297|183|B|||
0299|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0299|002|Z|does NOT have all possible information about this product. This||
0299|003|Z|information does not assure that this product is safe, effective,||
0299|004|Z|or appropriate for you. This information is not individual||
0299|005|Z|medical advice and does not substitute for the advice of your||
0299|006|Z|health care professional. Always ask your health care||
0299|007|Z|professional for complete information about this product and your||
0299|008|Z|specific health needs.||
0299|009|B|||
0299|010|T|ETANERCEPT - INJECTION||
0299|011|F|(ee-TAN-er-sept)||
0299|012|B|||
0299|013|C|COMMON BRAND NAME(S): Enbrel||
0299|014|B|||
0299|015|W|WARNING:  Because etanercept works by blocking the immune system,||
0299|016|W|it may lower your ability to fight infections. This may make you||
0299|017|W|more likely to get a serious (rarely fatal) infection (such as||
0299|018|W|fungal infections, bacterial infections including tuberculosis)||
0299|019|W|or make any infection you have worse. Tell your doctor your||
0299|020|W|medical history, especially of past/recent/current infections.||
0299|021|W|Also, tell your doctor if you have lived or traveled in areas||
0299|022|W|where certain fungal infections (such as coccidioidomycosis,||
0299|023|W|histoplasmosis) are common or if you have been near someone with||
0299|024|W|tuberculosis. Areas where these types of fungal infections are||
0299|025|W|commonly found include the Ohio and Mississippi River valleys and||
0299|026|W|the southwestern United States. You should be tested for||
0299|027|W|tuberculosis (TB skin test or chest X-ray) before and during||
0299|028|W|treatment with etanercept. Tell your doctor right away if you||
0299|029|W|have any signs of infection (such as sore throat or cough that||
0299|030|W|doesn't go away, fever, chills, night sweats, painful/frequent||
0299|031|W|urination, unusual vaginal discharge, white patches in the||
0299|032|W|mouth).||
0299|033|W|   The immune system is also important in preventing and||
0299|034|W|controlling cancer. Though it is very unlikely to happen, there||
0299|035|W|is a risk (especially in children/teens/young adults) of||
0299|036|W|developing cancer (such as lymphoma, skin) due to this medication||
0299|037|W|or due to your medical condition. Discuss the risks and benefits||
0299|038|W|of treatment with your doctor. Tell your doctor right away if you||
0299|039|W|develop symptoms such as fever that doesn't go away, unusual||
0299|040|W|lumps/growths, swollen or painful abdomen, unexplained weight||
0299|041|W|loss, or night sweats.||
0299|042|B|||
0299|043|U|USES:  This medication is used alone or in combination with an||
0299|044|U|immunosuppressant (such as methotrexate) to treat certain types||
0299|045|U|of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic,||
0299|046|U|and ankylosing spondylitis). Some brands of this medication are||
0299|047|U|also used to treat a skin condition called psoriasis. These||
0299|048|U|conditions are caused by an overactive immune system (autoimmune||
0299|049|U|disease). The immune system attacks the body's own healthy cells,||
0299|050|U|causing inflammation in the joints and skin.||
0299|051|U|   Etanercept controls your body's defensive response by blocking||
0299|052|U|the action of a certain natural substance (TNF) that is used by||
0299|053|U|the immune system. Treatment decreases redness, itching and scaly||
0299|054|U|patches in psoriasis as well as the pain, swelling and stiffness||
0299|055|U|of joints in arthritis. This medication can stop the progression||
0299|056|U|of disease and joint damage, resulting in improved daily||
0299|057|U|functioning and quality of life.||
0299|058|U|   This medication treats but does not cure autoimmune diseases.||
0299|059|U|Symptoms usually return within 1 month of stopping the||
0299|060|U|medication.||
0299|061|B|||
0299|062|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
0299|063|H|provided by your pharmacist before you start using this drug and||
0299|064|H|each time you get a refill. Ask your health care professional how||
0299|065|H|to prepare and use this medication. If you have any questions,||
0299|066|H|ask your doctor or pharmacist.||
0299|067|H|   Inject this medication under the skin as directed by your||
0299|068|H|doctor, usually once or twice a week. The injection is given in||
0299|069|H|the thigh, abdomen, or upper arm. The dosage is based on your||
0299|070|H|medical condition and response to treatment. Children's dosage is||
0299|071|H|also based on weight.||
0299|072|H|   Take the medication out of the refrigerator at least 15 to 30||
0299|073|H|minutes before you inject it to allow it to reach room||
0299|074|H|temperature. Do not warm up this medication any other way (for||
0299|075|H|example, do not heat it in the microwave or place it in hot||
0299|076|H|water). Do not shake the medication. Before using, check this||
0299|077|H|product for particles, cloudiness, or discoloration. The||
0299|078|H|prefilled syringe, cartridge, or pen injector may have small||
0299|079|H|white particles in the liquid. This is normal. If you see other||
0299|080|H|particles, cloudiness, or discoloration, do not use the liquid.||
0299|081|H|Before injecting each dose, clean the skin you are going to||
0299|082|H|inject into (the injection site) with rubbing alcohol. Change the||
0299|083|H|injection site each time to lessen injury under the skin. Do not||
0299|084|H|inject into skin that is sore, bruised, red, or hard. To lessen||
0299|085|H|bruising, do not rub the injection site after a shot. Learn how||
0299|086|H|to store and discard medical supplies safely.||
0299|087|H|   Use this medication regularly to get the most benefit from it.||
0299|088|H|To help you remember, use it on the same day(s) each week.||
0299|089|H|   You may notice improvement in your condition after 1 to 2||
0299|090|H|weeks, but it may take a few months to get the full benefit of||
0299|091|H|this medication. Tell your doctor if your condition does not get||
0299|092|H|better or if it gets worse.||
0299|093|B|||
0299|094|S|SIDE EFFECTS:  See also Warning section.||
0299|095|S|   Redness, itching, pain, or swelling at the injection site may||
0299|096|S|occur. This usually starts 1-2 days after the injection and||
0299|097|S|clears up in 3-5 days. Injection site reactions usually lessen||
0299|098|S|after the first month. Headache may also occur. If any of these||
0299|099|S|effects last or get worse, tell your doctor or pharmacist||
0299|100|S|promptly.||
0299|101|S|   Remember that this medication has been prescribed because your||
0299|102|S|doctor has judged that the benefit to you is greater than the||
0299|103|S|risk of side effects. Many people using this medication do not||
0299|104|S|have serious side effects.||
0299|105|S|   Tell your doctor right away if you have any serious side||
0299|106|S|effects, including: signs of liver disease (such as||
0299|107|S|nausea/vomiting that doesn't stop, dark urine, stomach/abdominal||
0299|108|S|pain, yellowing eyes/skin), a rash on nose and cheeks (butterfly||
0299|109|S|rash), dizziness, extreme tiredness, looking pale, hair loss,||
0299|110|S|swelling of the arms/legs, unusual bruising/bleeding, severe||
0299|111|S|headache, mental/mood changes, seizures, unexplained muscle||
0299|112|S|weakness, numbness/tingling of the hands/feet, unsteadiness,||
0299|113|S|vision changes.||
0299|114|S|   A very serious allergic reaction to this drug is rare.||
0299|115|S|However, get medical help right away if you notice any symptoms||
0299|116|S|of a serious allergic reaction, including: rash, itching/swelling||
0299|117|S|(especially of the face/tongue/throat), dizziness, trouble||
0299|118|S|breathing.||
0299|119|S|   This is not a complete list of possible side effects. If you||
0299|120|S|notice other effects not listed above, contact your doctor or||
0299|121|S|pharmacist.||
0299|122|S|   In the US -||
0299|123|S|   Call your doctor for medical advice about side effects. You||
0299|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0299|125|S|www.fda.gov/medwatch.||
0299|126|S|   In Canada - Call your doctor for medical advice about side||
0299|127|S|effects. You may report side effects to Health Canada at||
0299|128|S|1-866-234-2345.||
0299|129|B|||
0299|130|P|PRECAUTIONS:  Before using etanercept, tell your doctor or||
0299|131|P|pharmacist if you are allergic to it; or to latex or natural dry||
0299|132|P|rubber (found in some forms of etanercept); or if you have any||
0299|133|P|other allergies. This product may contain inactive ingredients,||
0299|134|P|which can cause allergic reactions or other problems. Talk to||
0299|135|P|your pharmacist for more details.||
0299|136|P|   Before using this medication, tell your doctor or pharmacist||
0299|137|P|your medical history, especially of: active or recurrent||
0299|138|P|infection (such as hepatitis B, HIV, tuberculosis), blood||
0299|139|P|disorders (such as leukemia, anemia), weakened bone marrow,||
0299|140|P|history of cancer (such as lymphoma), diabetes, heart failure,||
0299|141|P|seizures, nervous system problems (such as multiple sclerosis), a||
0299|142|P|certain liver problem (alcoholic hepatitis), blood vessel||
0299|143|P|disorders (such as vasculitis).||
0299|144|P|   Etanercept can make you more likely to get infections or may||
0299|145|P|make current infections worse. Stay away from anyone who has an||
0299|146|P|infection that may easily spread (such as chickenpox, COVID-19,||
0299|147|P|measles, flu). Talk to your doctor if you have been exposed to an||
0299|148|P|infection or for more details.||
0299|149|P|   Tell your health care professional that you are using||
0299|150|P|etanercept before having any immunizations/vaccinations. Avoid||
0299|151|P|contact with people who have recently received live vaccines||
0299|152|P|(such as flu vaccine inhaled through the nose).||
0299|153|P|   Before having surgery, tell your doctor or dentist about all||
0299|154|P|the products you use (including prescription drugs,||
0299|155|P|nonprescription drugs, and herbal products).||
0299|156|P|   Older adults may be at greater risk for infections while using||
0299|157|P|this drug.||
0299|158|P|   It is recommended that children be up to date on all their||
0299|159|P|childhood vaccinations before starting etanercept.||
0299|160|P|   During pregnancy, this medication should be used only when||
0299|161|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0299|162|P|benefits with your doctor. Mothers who have used this medication||
0299|163|P|during pregnancy should ask a doctor about||
0299|164|P|immunizations/vaccinations for their newborn babies.||
0299|165|P|   This medication passes into breast milk. Consult your doctor||
0299|166|P|before breastfeeding.||
0299|167|B|||
0299|168|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0299|169|I|medications work or increase your risk for serious side effects.||
0299|170|I|This document does not contain all possible drug interactions.||
0299|171|I|Keep a list of all the products you use (including||
0299|172|I|prescription/nonprescription drugs and herbal products) and share||
0299|173|I|it with your doctor and pharmacist. Do not start, stop, or change||
0299|174|I|the dosage of any medicines without your doctor's approval.||
0299|175|I|   Some products that may interact with this drug include:||
0299|176|I|abatacept, interleukin-1 blockers (such as anakinra, canakinumab,||
0299|177|I|rilonacept), other medications for autoimmune disease (such as||
0299|178|I|azathioprine, cyclophosphamide).||
0299|179|B|||
0299|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0299|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0299|182|O|poison control center right away. US residents can call||
0299|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0299|184|B|||
0299|185|N|NOTES:  Do not share this medication with others.||
0299|186|N|   Lab and/or medical tests (such as complete blood count, liver||
0299|187|N|function, TB test) should be done while you are using this||
0299|188|N|medication. Keep all medical and lab appointments. Consult your||
0299|189|N|doctor for more details.||
0299|190|N|   This medication may interfere with certain lab tests. Be sure||
0299|191|N|to tell the lab personnel that you are on this medication.||
0299|192|B|||
0299|193|D|MISSED DOSE:  It is important to get each dose of this medication||
0299|194|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0299|195|D|right away for a new dosing schedule. Do not double the dose to||
0299|196|D|catch up.||
0299|197|B|||
0299|198|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
0299|199|R|medication in the original packaging to protect from light. This||
0299|200|R|medication may also be stored at room temperature if needed. If||
0299|201|R|the medication is stored at room temperature, do not put it back||
0299|202|R|in the refrigerator and discard after 14 or 30 days (depending on||
0299|203|R|your product). Keep all medications away from children and pets.||
0299|204|R|   Do not flush medications down the toilet or pour them into a||
0299|205|R|drain unless instructed to do so. Properly discard this product||
0299|206|R|when it is expired or no longer needed. Consult your pharmacist||
0299|207|R|or local waste disposal company.||
0299|208|B|||
0299|209|A|Information last revised September 2024.||
0299|210|A|Copyright(c) 2025 First Databank, Inc.||
0299|211|B|||
0300|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0300|002|Z|does NOT have all possible information about this product. This||
0300|003|Z|information does not assure that this product is safe, effective,||
0300|004|Z|or appropriate for you. This information is not individual||
0300|005|Z|medical advice and does not substitute for the advice of your||
0300|006|Z|health care professional. Always ask your health care||
0300|007|Z|professional for complete information about this product and your||
0300|008|Z|specific health needs.||
0300|009|B|||
0300|010|T|ESTRADIOL/NORETHINDRONE ACETATE PATCH - TRANSDERMAL||
0300|011|F|(ES-tra-DYE-ol/nor-ETH-in-drone AS-e-tate)||
0300|012|B|||
0300|013|C|COMMON BRAND NAME(S): Combipatch||
0300|014|B|||
0300|015|W|WARNING:  Estrogens, either used alone or with a progestin, have||
0300|016|W|rarely caused very serious side effects. Discuss the risks and||
0300|017|W|benefits of hormone treatment with your doctor. Estrogens and||
0300|018|W|progestins should not be used to prevent heart disease or||
0300|019|W|dementia.||
0300|020|W|   In postmenopausal women, estrogen when used with a progestin||
0300|021|W|can increase the risk of heart disease (such as heart attacks),||
0300|022|W|stroke, serious blood clots in the lungs/legs, dementia, and||
0300|023|W|cancer of the breast/ovaries.||
0300|024|W|   The risk for serious side effects may depend on the dose of||
0300|025|W|estrogen and the length of time it is used. This medication||
0300|026|W|should be used at the lowest effective dose and for the shortest||
0300|027|W|amount of time. Discuss the use of this medication with your||
0300|028|W|doctor regularly (for example, every 3 to 6 months) to see if you||
0300|029|W|still need to use it. If you will be using this medication||
0300|030|W|long-term, you should have regular complete physical exams (for||
0300|031|W|example, once a year) as directed by your doctor. See also Notes||
0300|032|W|section.||
0300|033|B|||
0300|034|U|USES:  This medication contains 2 hormones: an estrogen||
0300|035|U|(estradiol) and a progestin (norethindrone). It is used by women||
0300|036|U|to help reduce symptoms of menopause (such as hot flashes,||
0300|037|U|vaginal dryness). These symptoms are caused by the body making||
0300|038|U|less estrogen. The progestin in this medication helps to reduce||
0300|039|U|the risk of cancer of the uterus which can be caused by using||
0300|040|U|estrogen. Women who have had their uterus removed do not need the||
0300|041|U|progestin. They should not use this combination medication. This||
0300|042|U|medication may also be used by women who are not able to produce||
0300|043|U|enough estrogen (for example, due to hypogonadism, primary||
0300|044|U|ovarian failure).||
0300|045|U|   If you are using this medication to treat symptoms only in and||
0300|046|U|around the vagina, products applied directly inside the vagina||
0300|047|U|should be considered before medications that are taken by mouth,||
0300|048|U|absorbed through the skin, or injected.||
0300|049|B|||
0300|050|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0300|051|H|from your pharmacist before you start using this medication and||
0300|052|H|each time you get a refill. If you have any questions, ask your||
0300|053|H|doctor or pharmacist.||
0300|054|H|   Peel off the backing from the patch and apply the patch to a||
0300|055|H|clean, dry area of the lower stomach. Press the patch firmly in||
0300|056|H|place for about 10 seconds to make sure it stays on. Do not apply||
0300|057|H|the patch on the breast or on oily, broken, or irritated skin.||
0300|058|H|Avoid applying the patch to areas of the skin where it might be||
0300|059|H|easily rubbed off (such as the waistline). When wearing the||
0300|060|H|patch, do not expose it to the sun for long periods of time. Use||
0300|061|H|this medication as directed by your doctor. The patch is usually||
0300|062|H|replaced twice a week (every 3 to 4 days). Follow the dosing||
0300|063|H|schedule carefully.||
0300|064|H|   The dosage is based on your medical condition and response to||
0300|065|H|treatment.||
0300|066|H|   When replacing your patch, make sure to apply the new patch to||
0300|067|H|a different area. Wait at least 1 week before applying a patch to||
0300|068|H|the same area. Fold the old patch in half with the sticky side||
0300|069|H|together and throw away in the trash away from children and pets.||
0300|070|H|Do not flush the patch down the toilet.||
0300|071|H|   If a patch falls off, reapply it to a different area. If the||
0300|072|H|patch does not stick completely, then apply a new patch and wear||
0300|073|H|it for the rest of the scheduled period. Do not wear 2 patches at||
0300|074|H|the same time.||
0300|075|H|   Use this medication regularly to get the most benefit from it.||
0300|076|H|To help you remember, change the patch on the same days each||
0300|077|H|week. Mark your calendar with a reminder.||
0300|078|H|   Tell your doctor if your condition does not get better or if||
0300|079|H|it gets worse.||
0300|080|B|||
0300|081|S|SIDE EFFECTS:  See also Warning section.||
0300|082|S|   Skin redness/irritation at the application site, abdominal||
0300|083|S|pain, nausea/vomiting, bloating, breast tenderness, headache,||
0300|084|S|back pain, or weight changes may occur. If any of these effects||
0300|085|S|last or get worse, tell your doctor or pharmacist promptly.||
0300|086|S|   Remember that this medication has been prescribed because your||
0300|087|S|doctor has judged that the benefit to you is greater than the||
0300|088|S|risk of side effects. Many people using this medication do not||
0300|089|S|have serious side effects.||
0300|090|S|   Tell your doctor right away if you have any serious side||
0300|091|S|effects, including: nausea/vomiting that doesn't stop,||
0300|092|S|mental/mood changes (such as depression, memory loss), breast||
0300|093|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
0300|094|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
0300|095|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
0300|096|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
0300|097|S|increased thirst/urination.||
0300|098|S|   This medication may rarely cause serious (sometimes fatal)||
0300|099|S|problems from blood clots (such as heart attack, stroke, blood||
0300|100|S|clots in the lungs or legs). Get medical help right away if you||
0300|101|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
0300|102|S|headaches, weakness on one side of the body, confusion, trouble||
0300|103|S|speaking, sudden vision changes, pain/swelling/warmth in the||
0300|104|S|groin/calf, shortness of breath/rapid breathing, sudden||
0300|105|S|dizziness/fainting.||
0300|106|S|   A very serious allergic reaction to this product is rare.||
0300|107|S|However, get medical help right away if you notice any symptoms||
0300|108|S|of a serious allergic reaction, including: rash, itching/swelling||
0300|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0300|110|S|breathing.||
0300|111|S|   This is not a complete list of possible side effects. If you||
0300|112|S|notice other effects not listed above, contact your doctor or||
0300|113|S|pharmacist.||
0300|114|S|   In the US -||
0300|115|S|   Call your doctor for medical advice about side effects. You||
0300|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0300|117|S|www.fda.gov/medwatch.||
0300|118|S|   In Canada - Call your doctor for medical advice about side||
0300|119|S|effects. You may report side effects to Health Canada at||
0300|120|S|1-866-234-2345.||
0300|121|B|||
0300|122|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0300|123|P|pharmacist if you are allergic to estradiol or norethindrone; or||
0300|124|P|if you have any other allergies. This product may contain||
0300|125|P|inactive ingredients, which can cause allergic reactions or other||
0300|126|P|problems. Talk to your pharmacist for more details.||
0300|127|P|   Before using this medication, tell your doctor or pharmacist||
0300|128|P|your medical history, especially of: vaginal bleeding of unknown||
0300|129|P|cause, certain cancers (such as breast cancer, cancer of the||
0300|130|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
0300|131|P|heart attack), liver disease, kidney disease, family medical||
0300|132|P|history (especially breast lumps, cancer, blood clots), family or||
0300|133|P|personal history of a certain swelling disorder (angioedema),||
0300|134|P|blood clotting disorders (such as protein C or protein S||
0300|135|P|deficiency), high blood pressure, diabetes, high blood||
0300|136|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
0300|137|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
0300|138|P|calcium in the blood), a certain hormone problem||
0300|139|P|(hypoparathyroidism), uterus problems (such as fibroids,||
0300|140|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
0300|141|P|headaches, a certain blood disorder (porphyria), mental/mood||
0300|142|P|disorders (such as dementia, depression).||
0300|143|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
0300|144|P|further increases your risk of stroke, blood clots, high blood||
0300|145|P|pressure, and heart attack, especially in women older than 35.||
0300|146|P|   Tell your doctor if you just had or will be having surgery, or||
0300|147|P|if you will be confined to a chair or bed for a long time (such||
0300|148|P|as a long plane flight). These conditions increase your risk of||
0300|149|P|getting blood clots, especially if you are using an estrogen||
0300|150|P|product. You may need to stop this medication for a time or take||
0300|151|P|special precautions.||
0300|152|P|   This medication may cause blotchy, dark areas on your face and||
0300|153|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0300|154|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0300|155|P|wear protective clothing when outdoors.||
0300|156|P|   If you are nearsighted or wear contact lenses, you may develop||
0300|157|P|vision problems or trouble wearing your contact lenses. Consult||
0300|158|P|your eye doctor if these problems occur.||
0300|159|P|   If you are going to have an MRI test, tell testing personnel||
0300|160|P|that you are using this patch. Some patches may contain metals||
0300|161|P|that can cause serious burns during an MRI. Ask your doctor||
0300|162|P|whether you will need to remove your patch before the test and||
0300|163|P|apply a new patch afterward, and how to do so properly.||
0300|164|P|   Older adults may be more sensitive to the side effects of this||
0300|165|P|drug, especially increased risk of stroke, breast cancer, and||
0300|166|P|dementia.||
0300|167|P|   This medication should not be used during pregnancy. If you||
0300|168|P|become pregnant or think you may be pregnant, tell your doctor||
0300|169|P|right away.||
0300|170|P|   This medication passes into breast milk. Consult your doctor||
0300|171|P|before breastfeeding.||
0300|172|B|||
0300|173|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0300|174|I|medications work or increase your risk for serious side effects.||
0300|175|I|This document does not contain all possible drug interactions.||
0300|176|I|Keep a list of all the products you use (including||
0300|177|I|prescription/nonprescription drugs and herbal products) and share||
0300|178|I|it with your doctor and pharmacist. Do not start, stop, or change||
0300|179|I|the dosage of any medicines without your doctor's approval.||
0300|180|I|   Some products that may interact with this drug include:||
0300|181|I|aromatase inhibitors (such as anastrozole, exemestane,||
0300|182|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
0300|183|I|tamoxifen, toremifene, tranexamic acid.||
0300|184|I|   This medication may interfere with certain lab tests (such as||
0300|185|I|metyrapone test), possibly causing false test results. Make sure||
0300|186|I|lab personnel and all your doctors know you use this drug.||
0300|187|B|||
0300|188|O|OVERDOSE:  This medication patch may be harmful if chewed or||
0300|189|O|swallowed. If someone has overdosed, remove the patch if||
0300|190|O|possible. For serious symptoms such as passing out or trouble||
0300|191|O|breathing, call 911. Otherwise, call a poison control center||
0300|192|O|right away. US residents can call 1-800-222-1222. Canada||
0300|193|O|residents can call 1-844-764-7669.||
0300|194|B|||
0300|195|N|NOTES:  Do not share this medication with others.||
0300|196|N|   Regular complete physical exams which include lab and/or||
0300|197|N|medical tests (such as blood pressure, breast exam/mammogram,||
0300|198|N|pelvic exam, Pap smear) should be done while you are using this||
0300|199|N|medication. Follow your doctor's instructions for examining your||
0300|200|N|breasts, and report any lumps right away. Keep all medical and||
0300|201|N|lab appointments. Consult your doctor for more details.||
0300|202|N|   Preventing or controlling high blood pressure, high||
0300|203|N|cholesterol, and diabetes can help to reduce your chances of||
0300|204|N|heart disease and stroke. Lifestyle changes that can help to||
0300|205|N|control or prevent these diseases include reducing stress, eating||
0300|206|N|a low fat/salt diet, losing weight if overweight, exercising||
0300|207|N|regularly, and stopping smoking. Keep your mind active with||
0300|208|N|mental exercises (such as reading, solving crossword puzzles) to||
0300|209|N|help prevent dementia. Talk to your doctor about lifestyle||
0300|210|N|changes that might benefit you.||
0300|211|N|   Lifestyle changes that may help reduce hot flashes include||
0300|212|N|stopping smoking, dressing lightly or in layers,||
0300|213|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
0300|214|N|reducing stress, and exercising regularly.||
0300|215|B|||
0300|216|D|MISSED DOSE:  If you forget to replace a patch at the scheduled||
0300|217|D|time, replace it as soon as you remember. Do not use more than||
0300|218|D|one patch at a time.||
0300|219|B|||
0300|220|R|STORAGE:  Store in the refrigerator. Do not open the sealed foil||
0300|221|R|pouch until you are ready to use the patch. Keep all medications||
0300|222|R|away from children and pets.||
0300|223|R|   Do not flush medications down the toilet or pour them into a||
0300|224|R|drain unless instructed to do so. Properly discard this product||
0300|225|R|when it is expired or no longer needed (see How to Use section).||
0300|226|B|||
0300|227|A|Information last revised October 2024.||
0300|228|A|Copyright(c) 2025 First Databank, Inc.||
0300|229|B|||
0301|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0301|002|Z|does NOT have all possible information about this product. This||
0301|003|Z|information does not assure that this product is safe, effective,||
0301|004|Z|or appropriate for you. This information is not individual||
0301|005|Z|medical advice and does not substitute for the advice of your||
0301|006|Z|health care professional. Always ask your health care||
0301|007|Z|professional for complete information about this product and your||
0301|008|Z|specific health needs.||
0301|009|B|||
0301|010|T|AZATHIOPRINE - INJECTION||
0301|011|F|(AY-za-THYE-oh-preen)||
0301|012|B|||
0301|013|C|COMMON BRAND NAME(S): Imuran||
0301|014|B|||
0301|015|W|WARNING:  Azathioprine may rarely increase your risk of||
0301|016|W|developing certain types of cancer (such as lymphoma, skin||
0301|017|W|cancer). This risk is higher in people using azathioprine after||
0301|018|W|an organ transplant and in children/young adults being treated||
0301|019|W|for certain bowel diseases (such as Crohn's disease, ulcerative||
0301|020|W|colitis). Keep all medical and lab appointments. Tell your doctor||
0301|021|W|right away if you develop any of the following symptoms: unusual||
0301|022|W|skin changes, change in the appearance/size of moles, unusual||
0301|023|W|growths/lumps, swollen lymph nodes, swollen abdomen, unexplained||
0301|024|W|weight loss, night sweats.||
0301|025|W|   This medication may decrease bone marrow function, an effect||
0301|026|W|that may lead to a low number of blood cells such as red cells,||
0301|027|W|white cells, and platelets. This effect can cause anemia,||
0301|028|W|decrease your body's ability to fight an infection, or cause easy||
0301|029|W|bruising/bleeding. Tell your doctor right away if you develop any||
0301|030|W|of the following symptoms: unusual tiredness, pale skin, signs of||
0301|031|W|infection (such as sore throat that doesn't go away, fever,||
0301|032|W|chills), easy bruising/bleeding.||
0301|033|B|||
0301|034|U|USES:  Azathioprine is used to prevent organ rejection in people||
0301|035|U|who have received a kidney transplant. It is usually used along||
0301|036|U|with other medications to allow your new kidney to function||
0301|037|U|normally. Azathioprine is also used to treat rheumatoid||
0301|038|U|arthritis. In this condition, the body's defense system (immune||
0301|039|U|system) attacks healthy joints. Azathioprine belongs to a class||
0301|040|U|of drugs known as immunosuppressants. It works by weakening the||
0301|041|U|immune system to help your body accept the new kidney as if it||
0301|042|U|were your own (in the case of an organ transplant) or to prevent||
0301|043|U|further damage to your joints (in the case of rheumatoid||
0301|044|U|arthritis).||
0301|045|U|   This medication is given by injection until you are able to||
0301|046|U|take azathioprine by mouth.||
0301|047|U|   Talk to your doctor about the risks and benefits of||
0301|048|U|azathioprine, especially when used by children and young adults.||
0301|049|B|||
0301|050|V|OTHER USES:  This section contains uses of this drug that are not||
0301|051|V|listed in the approved professional labeling for the drug but||
0301|052|V|that may be prescribed by your health care professional. Use this||
0301|053|V|drug for a condition that is listed in this section only if it||
0301|054|V|has been so prescribed by your health care professional.||
0301|055|V|   This drug may also be used to reduce the risk of rejection of||
0301|056|V|other transplanted organs. It may also be used for certain types||
0301|057|V|of bowel conditions (Crohn's disease, ulcerative colitis), and||
0301|058|V|other immune system problems.||
0301|059|B|||
0301|060|H|HOW TO USE:  This medication is given by injection into a vein by||
0301|061|H|a health care professional. It is given as directed by your||
0301|062|H|doctor, usually once or twice a day.||
0301|063|H|   The dosage is based on your medical condition, weight, and||
0301|064|H|response to treatment.||
0301|065|H|   Use this medication regularly to get the most benefit from it.||
0301|066|H|To help you remember, use it at the same time(s) each day.||
0301|067|H|   For the treatment of arthritis, it may take up to 2 months||
0301|068|H|before your symptoms get better. Tell your doctor if your||
0301|069|H|condition does not get better after 3 months of treatment.||
0301|070|B|||
0301|071|S|SIDE EFFECTS:  See also Warning section.||
0301|072|S|   Nausea or vomiting may occur. Giving this medication after||
0301|073|S|meals may help lessen these effects. Temporary hair loss may also||
0301|074|S|occur. If any of these effects last or get worse, tell your||
0301|075|S|doctor or pharmacist promptly.||
0301|076|S|   People using this medication may have serious side effects.||
0301|077|S|However, you have been prescribed this drug because your doctor||
0301|078|S|has judged that the benefit to you is greater than the risk of||
0301|079|S|side effects. Careful monitoring by your doctor may decrease your||
0301|080|S|risk.||
0301|081|S|   Tell your doctor right away if you have any serious side||
0301|082|S|effects, including: diarrhea, new or worsening joint/muscle pain.||
0301|083|S|   Get medical help right away if you have any very serious side||
0301|084|S|effects, including: symptoms of liver disease (such as||
0301|085|S|nausea/vomiting that doesn't stop, stomach/abdominal pain, dark||
0301|086|S|urine, yellowing eyes/skin).||
0301|087|S|   This medication may increase your risk of getting a rare but||
0301|088|S|very serious (possibly fatal) brain infection (progressive||
0301|089|S|multifocal leukoencephalopathy-PML). Get medical help right away||
0301|090|S|if you have any of these side effects: clumsiness, loss of||
0301|091|S|coordination/balance, weakness, sudden change in your thinking||
0301|092|S|(such as confusion, difficulty concentrating, memory loss),||
0301|093|S|difficulty talking/walking, seizure, vision changes.||
0301|094|S|   A very serious allergic reaction to this drug is rare.||
0301|095|S|However, get medical help right away if you notice any symptoms||
0301|096|S|of a serious allergic reaction, including: rash, itching/swelling||
0301|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0301|098|S|breathing.||
0301|099|S|   This is not a complete list of possible side effects. If you||
0301|100|S|notice other effects not listed above, contact your doctor or||
0301|101|S|pharmacist.||
0301|102|S|   In the US -||
0301|103|S|   Call your doctor for medical advice about side effects. You||
0301|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0301|105|S|www.fda.gov/medwatch.||
0301|106|S|   In Canada - Call your doctor for medical advice about side||
0301|107|S|effects. You may report side effects to Health Canada at||
0301|108|S|1-866-234-2345.||
0301|109|B|||
0301|110|P|PRECAUTIONS:  Before using azathioprine, tell your doctor or||
0301|111|P|pharmacist if you are allergic to it; or to mercaptopurine; or if||
0301|112|P|you have any other allergies. This product may contain inactive||
0301|113|P|ingredients, which can cause allergic reactions or other||
0301|114|P|problems. Talk to your pharmacist for more details.||
0301|115|P|   Before using this medication, tell your doctor or pharmacist||
0301|116|P|your medical history, especially of: kidney disease, liver||
0301|117|P|disease, cancer, certain enzyme disorders (TPMT deficiency,||
0301|118|P|NUDT15 deficiency).||
0301|119|P|   This medication may increase your risk of developing skin||
0301|120|P|cancer. Limit your time in the sun. Avoid tanning booths and||
0301|121|P|sunlamps. Use sunscreen and wear protective clothing when||
0301|122|P|outdoors. Your doctor may direct you to avoid phototherapy while||
0301|123|P|you use this product. Ask your doctor for details.||
0301|124|P|   Azathioprine can make you more likely to get infections or may||
0301|125|P|make current infections worse. Stay away from anyone who has an||
0301|126|P|infection that may easily spread (such as chickenpox, COVID-19,||
0301|127|P|measles, flu). Talk to your doctor if you have been exposed to an||
0301|128|P|infection or for more details.||
0301|129|P|   Before having surgery, tell your doctor or dentist about all||
0301|130|P|the products you use (including prescription drugs,||
0301|131|P|nonprescription drugs, and herbal products).||
0301|132|P|   Tell your health care professional that you are using||
0301|133|P|azathioprine before having any immunizations/vaccinations. Avoid||
0301|134|P|contact with people who have recently received live vaccines||
0301|135|P|(such as flu vaccine inhaled through the nose).||
0301|136|P|   To lower the chance of getting cut, bruised, or injured, use||
0301|137|P|caution with sharp objects like razors and nail cutters, and||
0301|138|P|avoid activities such as contact sports.||
0301|139|P|   Tell your doctor if you are pregnant or plan to become||
0301|140|P|pregnant. You should not become pregnant while using||
0301|141|P|azathioprine. Azathioprine may harm an unborn baby. Ask about||
0301|142|P|reliable forms of birth control while using this medication. If||
0301|143|P|you become pregnant, talk to your doctor right away about the||
0301|144|P|risks and benefits of this medication.||
0301|145|P|   This medication passes into breast milk and may have||
0301|146|P|undesirable effects on a nursing infant. Consult your doctor||
0301|147|P|before breastfeeding.||
0301|148|B|||
0301|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0301|150|I|medications work or increase your risk for serious side effects.||
0301|151|I|This document does not contain all possible drug interactions.||
0301|152|I|Keep a list of all the products you use (including||
0301|153|I|prescription/nonprescription drugs and herbal products) and share||
0301|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
0301|155|I|the dosage of any medicines without your doctor's approval.||
0301|156|I|   Some products that may interact with this drug are:||
0301|157|I|febuxostat, past or present use of certain cancer drugs (such as||
0301|158|I|cyclophosphamide, melphalan), other drugs that weaken the immune||
0301|159|I|system/increase the risk of infection (such as rituximab,||
0301|160|I|tofacitinib).||
0301|161|I|   Azathioprine is very similar to mercaptopurine. Do not use||
0301|162|I|medications containing mercaptopurine while using azathioprine.||
0301|163|B|||
0301|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0301|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0301|166|O|poison control center right away. US residents can call||
0301|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0301|168|B|||
0301|169|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0301|170|N|liver/kidney function) should be done while you are using this||
0301|171|N|medication. Keep all medical and lab appointments. Consult your||
0301|172|N|doctor for more details.||
0301|173|N|   If you have had an organ transplant, attend a transplant||
0301|174|N|education class or support group. Learn the symptoms of organ||
0301|175|N|rejection such as a feeling of being ill, fever, pain around the||
0301|176|N|transplanted organ, and the signs of a failing transplanted organ||
0301|177|N|(a decrease in the amount of urine with kidney transplant). Get||
0301|178|N|medical help right away if these symptoms occur.||
0301|179|B|||
0301|180|D|MISSED DOSE:  It is important to get each dose of this medication||
0301|181|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0301|182|D|right away for a new dosing schedule.||
0301|183|B|||
0301|184|R|STORAGE:  Not applicable. This medication is given in a hospital||
0301|185|R|or clinic and will not be stored at home.||
0301|186|B|||
0301|187|M|MEDICAL ALERT:  Your condition can cause complications in a||
0301|188|M|medical emergency. For information about enrolling in MedicAlert,||
0301|189|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0301|190|B|||
0301|191|A|Information last revised May 2024.||
0301|192|A|Copyright(c) 2025 First Databank, Inc.||
0301|193|B|||
0302|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0302|002|Z|does NOT have all possible information about this product. This||
0302|003|Z|information does not assure that this product is safe, effective,||
0302|004|Z|or appropriate for you. This information is not individual||
0302|005|Z|medical advice and does not substitute for the advice of your||
0302|006|Z|health care professional. Always ask your health care||
0302|007|Z|professional for complete information about this product and your||
0302|008|Z|specific health needs.||
0302|009|B|||
0302|010|T|SODIUM POLYSTYRENE SULFONATE SUSPENSION - ORAL, RECTAL||
0302|011|F|(SOE-dee-um POL-ee-STYE-reen SUL-foe-nate)||
0302|012|B|||
0302|013|C|COMMON BRAND NAME(S): SPS||
0302|014|B|||
0302|015|U|USES:  This medication is used to treat a high level of potassium||
0302|016|U|in your blood. Too much potassium in your blood can sometimes||
0302|017|U|cause heart rhythm problems. Sodium polystyrene sulfonate works||
0302|018|U|by helping your body get rid of extra potassium.||
0302|019|B|||
0302|020|H|HOW TO USE:  Shake the bottle well before using.||
0302|021|H|   Do not heat this medication because it may not work as well.||
0302|022|H|   Take this medication by mouth, or use it rectally as directed||
0302|023|H|by your doctor.||
0302|024|H|   If you are taking this medication by mouth, take it as||
0302|025|H|directed by your doctor, usually 1 to 4 times a day. Carefully||
0302|026|H|measure the dose using a special measuring device/spoon, or use||
0302|027|H|the prescribed number of pre-measured bottles of suspension. Do||
0302|028|H|not use a household spoon because you may not get the correct||
0302|029|H|dose. Stay upright (sitting, standing, or walking) and do not lie||
0302|030|H|down for at least an hour after your dose. Consult your doctor||
0302|031|H|for details.||
0302|032|H|   Sodium polystyrene sulfonate may decrease your absorption of||
0302|033|H|other medications. Take your other medications as directed by||
0302|034|H|your doctor, usually at least 3 hours before or 3 hours after||
0302|035|H|sodium polystyrene sulfonate. Ask your doctor or pharmacist for||
0302|036|H|more information or if you have any questions.||
0302|037|H|   To give this medication rectally as an enema, use the||
0302|038|H|prescribed dose as directed by your doctor, usually every 6 hours||
0302|039|H|as needed. Consult your doctor or pharmacist for directions on||
0302|040|H|how to prepare the dose and how to use the enema. Follow||
0302|041|H|instructions for the use of a cleansing enema both before and||
0302|042|H|after your dose of sodium polystyrene sulfonate. The cleansing||
0302|043|H|enema after each rectal dose of this medication should be a||
0302|044|H|non-sodium-containing enema.||
0302|045|H|   The dosage and length of treatment are based on your medical||
0302|046|H|condition and response to treatment. Follow your doctor's||
0302|047|H|instructions carefully. Do not use more of this medication or use||
0302|048|H|it for longer than directed because your potassium blood level||
0302|049|H|may drop too low.||
0302|050|B|||
0302|051|S|SIDE EFFECTS:  Loss of appetite, nausea, vomiting, or||
0302|052|S|constipation may occur. Diarrhea may occur less often. If any of||
0302|053|S|these effects last or get worse, tell your doctor or pharmacist||
0302|054|S|promptly.||
0302|055|S|   To prevent constipation, eat dietary fiber, drink enough||
0302|056|S|water, and exercise. You may also need to take a laxative. Ask||
0302|057|S|your pharmacist which type of laxative is right for you.||
0302|058|S|   Remember that this medication has been prescribed because your||
0302|059|S|doctor has judged that the benefit to you is greater than the||
0302|060|S|risk of side effects. Many people using this medication do not||
0302|061|S|have serious side effects.||
0302|062|S|   Tell your doctor right away if you have any serious side||
0302|063|S|effects, including: muscle weakness/spasms, fast/irregular||
0302|064|S|heartbeat, mental/mood changes (such as irritability, confusion,||
0302|065|S|slowed thinking), swelling hands/ankles/feet.||
0302|066|S|   This medication may cause serious (rarely fatal) intestinal||
0302|067|S|problems (such as bleeding, blockage). Get medical help right||
0302|068|S|away if any of these very serious side effects occur: severe||
0302|069|S|constipation, bloating/swelling/pain in the stomach/abdomen,||
0302|070|S|black/bloody stools, vomit that looks like coffee grounds.||
0302|071|S|   Get medical help right away if you have any very serious side||
0302|072|S|effects, including: inability to move your muscles (paralysis),||
0302|073|S|seizures.||
0302|074|S|   A very serious allergic reaction to this drug is rare.||
0302|075|S|However, get medical help right away if you notice any symptoms||
0302|076|S|of a serious allergic reaction, including: rash, itching/swelling||
0302|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0302|078|S|breathing.||
0302|079|S|   This is not a complete list of possible side effects. If you||
0302|080|S|notice other effects not listed above, contact your doctor or||
0302|081|S|pharmacist.||
0302|082|S|   In the US -||
0302|083|S|   Call your doctor for medical advice about side effects. You||
0302|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0302|085|S|www.fda.gov/medwatch.||
0302|086|S|   In Canada - Call your doctor for medical advice about side||
0302|087|S|effects. You may report side effects to Health Canada at||
0302|088|S|1-866-234-2345.||
0302|089|B|||
0302|090|P|PRECAUTIONS:  Before using sodium polystyrene sulfonate, tell||
0302|091|P|your doctor or pharmacist if you are allergic to it; or if you||
0302|092|P|have any other allergies. This product may contain inactive||
0302|093|P|ingredients, which can cause allergic reactions or other||
0302|094|P|problems. Talk to your pharmacist for more details.||
0302|095|P|   This medication contains a large amount of salt (sodium). Do||
0302|096|P|not use salt substitutes that contain potassium without asking||
0302|097|P|your doctor first. If you have any of these conditions, follow||
0302|098|P|your doctor's instructions for limiting the amount of sodium in||
0302|099|P|your diet: kidney problems, heart failure, high blood pressure,||
0302|100|P|swelling hands/ankles/feet.||
0302|101|P|   Before using this medication, tell your doctor or pharmacist||
0302|102|P|your medical history, especially of: stomach/intestine/bowel||
0302|103|P|problems (such as inflammatory bowel disease, bowel obstruction,||
0302|104|P|chronic constipation, fecal impaction), low level of potassium in||
0302|105|P|the blood.||
0302|106|P|   Before having surgery, tell your doctor or dentist about all||
0302|107|P|the products you use (including prescription drugs,||
0302|108|P|nonprescription drugs, and herbal products).||
0302|109|P|   Older adults may be at greater risk for severe constipation.||
0302|110|P|   This medication must not be given by mouth to newborns,||
0302|111|P|especially premature infants. Also, newborns with slow gut||
0302|112|P|function must not use this drug. Caution is advised when using||
0302|113|P|this medication rectally in newborns and children. They may be||
0302|114|P|more sensitive to the side effects of this drug, especially||
0302|115|P|severe constipation and intestinal problems.||
0302|116|P|   Tell your doctor if you are pregnant before using this||
0302|117|P|medication.||
0302|118|P|   This medication does not pass into breast milk and is unlikely||
0302|119|P|to harm a nursing infant. Consult your doctor before||
0302|120|P|breastfeeding.||
0302|121|B|||
0302|122|I|DRUG INTERACTIONS:  See also How to Use section.||
0302|123|I|   Drug interactions may change how your medications work or||
0302|124|I|increase your risk for serious side effects. This document does||
0302|125|I|not contain all possible drug interactions. Keep a list of all||
0302|126|I|the products you use (including prescription/nonprescription||
0302|127|I|drugs and herbal products) and share it with your doctor and||
0302|128|I|pharmacist. Do not start, stop, or change the dosage of any||
0302|129|I|medicines without your doctor's approval.||
0302|130|I|   Some products that may interact with this drug include:||
0302|131|I|antacids/laxatives that contain aluminum/calcium/magnesium (such||
0302|132|I|as aluminum carbonate, aluminum hydroxide, calcium carbonate,||
0302|133|I|magnesium hydroxide).||
0302|134|I|   Do not use any laxatives that contain sorbitol with this||
0302|135|I|medication. Doing so may increase your risk of intestinal||
0302|136|I|problems. See also Side Effects section.||
0302|137|B|||
0302|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0302|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0302|140|O|poison control center right away. US residents can call||
0302|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0302|142|O|Symptoms of overdose may include: mental/mood changes, muscle||
0302|143|O|weakness, fast/irregular heartbeat, slowed breathing, paralysis.||
0302|144|B|||
0302|145|N|NOTES:  Do not share this medication with others.||
0302|146|N|   Lab and/or medical tests (such as blood levels of potassium||
0302|147|N|and other minerals, EKG) should be done while you are using this||
0302|148|N|medication. Keep all medical and lab appointments. Consult your||
0302|149|N|doctor for more details.||
0302|150|B|||
0302|151|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0302|152|D|If it is near the time of the next dose, skip the missed dose.||
0302|153|D|Use your next dose at the regular time. Do not double the dose to||
0302|154|D|catch up.||
0302|155|B|||
0302|156|R|STORAGE:  Different brands of this medication have different||
0302|157|R|storage needs. Check the product package for instructions on how||
0302|158|R|to store your brand, or ask your pharmacist. Keep all medications||
0302|159|R|away from children and pets.||
0302|160|R|   Do not flush medications down the toilet or pour them into a||
0302|161|R|drain unless instructed to do so. Properly discard this product||
0302|162|R|when it is expired or no longer needed. Consult your pharmacist||
0302|163|R|or local waste disposal company.||
0302|164|B|||
0302|165|A|Information last revised September 2024.||
0302|166|A|Copyright(c) 2025 First Databank, Inc.||
0302|167|B|||
0307|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0307|002|Z|does NOT have all possible information about this product. This||
0307|003|Z|information does not assure that this product is safe, effective,||
0307|004|Z|or appropriate for you. This information is not individual||
0307|005|Z|medical advice and does not substitute for the advice of your||
0307|006|Z|health care professional. Always ask your health care||
0307|007|Z|professional for complete information about this product and your||
0307|008|Z|specific health needs.||
0307|009|B|||
0307|010|T|ORLISTAT - ORAL||
0307|011|F|(OR-li-stat)||
0307|012|B|||
0307|013|C|COMMON BRAND NAME(S): Alli, Xenical||
0307|014|B|||
0307|015|U|USES:  This medication is used with a doctor-approved exercise,||
0307|016|U|behavior change, and reduced-calorie diet program to help you||
0307|017|U|lose weight. It is used by certain overweight people, such as||
0307|018|U|those who are obese or have weight-related medical problems.||
0307|019|U|Taking orlistat can also help keep you from gaining back weight||
0307|020|U|you have lost. Losing weight and keeping it off can lessen the||
0307|021|U|many health risks that come with obesity, including heart||
0307|022|U|disease, diabetes, high blood pressure, and a shorter life.||
0307|023|U|   Dietary fats need to be broken down into smaller pieces before||
0307|024|U|the body can absorb them. Orlistat works by blocking the enzyme||
0307|025|U|that breaks down fats in your diet. This undigested fat then||
0307|026|U|passes out of your body in your bowel movement. Orlistat does not||
0307|027|U|block the absorption of calories from sugar and other non-fat||
0307|028|U|foods, so you still need to restrict your total intake of||
0307|029|U|calories.||
0307|030|B|||
0307|031|H|HOW TO USE:  If you are taking the over-the-counter product to||
0307|032|H|self-treat, read all directions on the product package before||
0307|033|H|taking this medication.||
0307|034|H|   If your doctor has prescribed this medication, read the||
0307|035|H|Patient Information Leaflet if available from your pharmacist||
0307|036|H|before you start taking orlistat and each time you get a refill.||
0307|037|H|Take this medication by mouth as directed by your doctor, usually||
0307|038|H|3 times daily. Take it with liquid sometime during each meal that||
0307|039|H|contains fat or within 1 hour after the meal. If you miss a meal||
0307|040|H|or your meal contains no fat, skip that dose of the medication.||
0307|041|H|To decrease the chance of unpleasant side effects, it is very||
0307|042|H|important that no more than 30% of the calories in your diet come||
0307|043|H|from fat. Your daily intake of fat, protein, and carbohydrates||
0307|044|H|should be evenly spread over 3 main meals.||
0307|045|H|   Do not increase your dose or use this drug more often or for||
0307|046|H|longer than prescribed. Your condition will not improve any||
0307|047|H|faster, and your risk of side effects will increase.||
0307|048|H|   Because this drug can interfere with the absorption of certain||
0307|049|H|vitamins (fat-soluble vitamins including A, D, E, K), a daily||
0307|050|H|multivitamin supplement containing these nutrients is||
0307|051|H|recommended. Take the multivitamin at least 2 hours before or 2||
0307|052|H|hours after taking orlistat (such as at bedtime).||
0307|053|H|   If you take cyclosporine, take it at least 3 hours before or||
0307|054|H|after orlistat to make sure the full dose of cyclosporine is||
0307|055|H|absorbed into your bloodstream. If you take levothyroxine, take||
0307|056|H|it at least 4 hours before or after orlistat.||
0307|057|H|   You should see some weight loss within 2 weeks after you start||
0307|058|H|orlistat. Tell your doctor if your condition does not get better||
0307|059|H|or if it gets worse.||
0307|060|B|||
0307|061|S|SIDE EFFECTS:  Changes in your bowel function often occur because||
0307|062|S|of the unabsorbed fat. Fatty/oily stool, oily spotting,||
0307|063|S|intestinal gas with discharge, a feeling of needing to have a||
0307|064|S|bowel movement right away, increased number of bowel movements,||
0307|065|S|or poor bowel control may occur. These side effects may get worse||
0307|066|S|if you eat more fat than you should. If these effects last or get||
0307|067|S|worse, notify your doctor promptly.||
0307|068|S|   If your doctor has directed you to use this medication,||
0307|069|S|remember that your doctor has judged that the benefit to you is||
0307|070|S|greater than the risk of side effects. Many people using this||
0307|071|S|medication do not have serious side effects.||
0307|072|S|   Stop taking this medication and tell your doctor right away if||
0307|073|S|you have any serious side effects, including: symptoms of liver||
0307|074|S|disease (such as nausea/vomiting that doesn't stop, severe||
0307|075|S|stomach/abdominal pain, dark urine, yellowing eyes/skin),||
0307|076|S|symptoms of kidney stones (such as back pain, pain when||
0307|077|S|urinating, pink/bloody urine).||
0307|078|S|   A very serious allergic reaction to this drug is rare.||
0307|079|S|However, get medical help right away if you notice any symptoms||
0307|080|S|of a serious allergic reaction, including: rash, itching/swelling||
0307|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0307|082|S|breathing.||
0307|083|S|   This is not a complete list of possible side effects. If you||
0307|084|S|notice other effects not listed above, contact your doctor or||
0307|085|S|pharmacist.||
0307|086|S|   In the US -||
0307|087|S|   Call your doctor for medical advice about side effects. You||
0307|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0307|089|S|www.fda.gov/medwatch.||
0307|090|S|   In Canada - Call your doctor for medical advice about side||
0307|091|S|effects. You may report side effects to Health Canada at||
0307|092|S|1-866-234-2345.||
0307|093|B|||
0307|094|P|PRECAUTIONS:  Before taking orlistat, tell your doctor or||
0307|095|P|pharmacist if you are allergic to it; or if you have any other||
0307|096|P|allergies. This product may contain inactive ingredients, which||
0307|097|P|can cause allergic reactions or other problems. Talk to your||
0307|098|P|pharmacist for more details.||
0307|099|P|   Before using this medication, tell your doctor or pharmacist||
0307|100|P|your medical history, especially of: a certain digestive problem||
0307|101|P|(chronic malabsorption syndrome), a certain gall bladder problem||
0307|102|P|(cholestasis), underactive thyroid (hypothyroidism), kidney||
0307|103|P|problems (such as kidney stones, hyperoxaluria), certain eating||
0307|104|P|disorders (anorexia nervosa/bulimia), HIV infection, seizures.||
0307|105|P|   Before having surgery, tell your doctor or dentist about all||
0307|106|P|the products you use (including prescription drugs,||
0307|107|P|nonprescription drugs, and herbal products).||
0307|108|P|   If you are diabetic, weight loss may improve your blood sugar||
0307|109|P|control. Be sure to check your blood sugar regularly and tell||
0307|110|P|your doctor the results. Your doctor may need to adjust your||
0307|111|P|diabetes medication, exercise program, or diet.||
0307|112|P|   This medication must not be used during pregnancy. Weight loss||
0307|113|P|offers no potential benefit to a pregnant woman and may harm an||
0307|114|P|unborn baby. If you become pregnant or think you may be pregnant,||
0307|115|P|tell your doctor right away.||
0307|116|P|   It is unknown if this drug passes into breast milk. Consult||
0307|117|P|your doctor before breastfeeding.||
0307|118|B|||
0307|119|I|DRUG INTERACTIONS:  See also How to Use section.||
0307|120|I|   Drug interactions may change how your medications work or||
0307|121|I|increase your risk for serious side effects. This document does||
0307|122|I|not contain all possible drug interactions. Keep a list of all||
0307|123|I|the products you use (including prescription/nonprescription||
0307|124|I|drugs and herbal products) and share it with your doctor and||
0307|125|I|pharmacist. Do not start, stop, or change the dosage of any||
0307|126|I|medicines without your doctor's approval.||
0307|127|I|   Some products that may interact with this drug include: "blood||
0307|128|I|thinners" (such as warfarin), HIV medications (such as||
0307|129|I|atazanavir, efavirenz, emtricitabine, lopinavir, tenofovir),||
0307|130|I|ritonavir, triheptanoin.||
0307|131|I|   If you are taking medications to treat seizures, orlistat may||
0307|132|I|cause these drugs to not work as well. Stop taking orlistat and||
0307|133|I|tell your doctor right away if your seizures are happening more||
0307|134|I|often or are getting worse.||
0307|135|B|||
0307|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0307|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0307|138|O|poison control center right away. US residents can call||
0307|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0307|140|B|||
0307|141|N|NOTES:  If this medication has been prescribed for you, do not||
0307|142|N|share this medication with others.||
0307|143|N|   Lab tests (such as kidney function) may be done while you are||
0307|144|N|taking this medication. Keep all medical and lab appointments.||
0307|145|N|Consult your doctor for more details.||
0307|146|N|   For best results, this medication should be used along with a||
0307|147|N|doctor-approved exercise program and diet plan. Consult your||
0307|148|N|doctor or dietician for help designing an appropriate exercise||
0307|149|N|and food plan for you.||
0307|150|B|||
0307|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0307|152|D|remember. If it is more than 1 to 2 hours since your meal, skip||
0307|153|D|the missed dose since most of the fat from your meal will already||
0307|154|D|have been absorbed and the medication will not work. Do not||
0307|155|D|double the dose to catch up.||
0307|156|B|||
0307|157|R|STORAGE:  Store at room temperature away from light and moisture.||
0307|158|R|Do not store in the bathroom. Keep all medications away from||
0307|159|R|children and pets.||
0307|160|R|   Do not flush medications down the toilet or pour them into a||
0307|161|R|drain unless instructed to do so. Properly discard this product||
0307|162|R|when it is expired or no longer needed. Consult your pharmacist||
0307|163|R|or local waste disposal company.||
0307|164|B|||
0307|165|A|Information last revised November 2024.||
0307|166|A|Copyright(c) 2025 First Databank, Inc.||
0307|167|B|||
0309|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0309|002|Z|does NOT have all possible information about this product. This||
0309|003|Z|information does not assure that this product is safe, effective,||
0309|004|Z|or appropriate for you. This information is not individual||
0309|005|Z|medical advice and does not substitute for the advice of your||
0309|006|Z|health care professional. Always ask your health care||
0309|007|Z|professional for complete information about this product and your||
0309|008|Z|specific health needs.||
0309|009|B|||
0309|010|T|ROSIGLITAZONE - ORAL||
0309|011|F|(ROE-si-GLI-ta-zone)||
0309|012|B|||
0309|013|C|COMMON BRAND NAME(S): Avandia||
0309|014|B|||
0309|015|W|WARNING:  This medication may rarely cause or worsen a certain||
0309|016|W|heart problem (heart failure). Tell your doctor right away if you||
0309|017|W|notice any symptoms of heart failure, including: shortness of||
0309|018|W|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
0309|019|W|weight gain.||
0309|020|W|   This medication is not recommended for people with certain||
0309|021|W|types of heart failure. Before using this medication, tell your||
0309|022|W|doctor if you have heart failure.||
0309|023|B|||
0309|024|U|USES:  Rosiglitazone is used with a proper diet and exercise||
0309|025|U|program to control high blood sugar in people with type 2||
0309|026|U|diabetes. Controlling high blood sugar helps prevent kidney||
0309|027|U|damage, blindness, nerve problems, loss of limbs, and sexual||
0309|028|U|function problems. Proper control of diabetes may also lessen||
0309|029|U|your risk of a heart attack or stroke. Rosiglitazone belongs to||
0309|030|U|the class of drugs known as glitazones. It lowers blood sugar by||
0309|031|U|helping to restore your body's proper response to insulin.||
0309|032|B|||
0309|033|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0309|034|H|Patient Information Leaflet provided by your pharmacist before||
0309|035|H|you start taking rosiglitazone and each time you get a refill. If||
0309|036|H|you have any questions, ask your doctor or pharmacist.||
0309|037|H|   Take this medication by mouth with or without food as directed||
0309|038|H|by your doctor, usually once or twice daily. The dosage is based||
0309|039|H|on your medical condition and response to treatment.||
0309|040|H|   Use this medication regularly to get the most benefit from it.||
0309|041|H|To help you remember, take it at the same time(s) each day.||
0309|042|H|   It may take up to 2 to 3 months before you get the full||
0309|043|H|benefit of this drug.||
0309|044|H|   Tell your doctor if your condition does not get better or if||
0309|045|H|it gets worse (your blood sugar is too high or too low).||
0309|046|B|||
0309|047|S|SIDE EFFECTS:  See also Warning section.||
0309|048|S|   Headache or cough may occur. If either of these effects lasts||
0309|049|S|or gets worse, tell your doctor or pharmacist promptly.||
0309|050|S|   Remember that this medication has been prescribed because your||
0309|051|S|doctor has judged that the benefit to you is greater than the||
0309|052|S|risk of side effects. Many people using this medication do not||
0309|053|S|have serious side effects.||
0309|054|S|   Tell your doctor right away if you have any serious side||
0309|055|S|effects, including: fast/pounding heartbeat, changes in menstrual||
0309|056|S|cycles, bone fracture, vision changes (such as color changes or||
0309|057|S|night vision problems).||
0309|058|S|   Rosiglitazone has rarely caused very serious liver disease.||
0309|059|S|Tell your doctor right away if you develop symptoms of liver||
0309|060|S|disease, including: nausea/vomiting that doesn't stop, loss of||
0309|061|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0309|062|S|urine.||
0309|063|S|   This medication does not usually cause low blood sugar||
0309|064|S|(hypoglycemia). Low blood sugar may occur if this drug is||
0309|065|S|prescribed with other diabetes medications, or if you do not get||
0309|066|S|enough calories from food, or if you do unusually heavy exercise.||
0309|067|S|Talk with your doctor or pharmacist about whether the dose of||
0309|068|S|your other diabetes medication(s) needs to be lowered. Symptoms||
0309|069|S|of low blood sugar include sudden sweating, shaking, fast||
0309|070|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
0309|071|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
0309|072|S|treat low blood sugar. If you don't have these reliable forms of||
0309|073|S|glucose, rapidly raise your blood sugar by eating a quick source||
0309|074|S|of sugar such as table sugar, honey, or candy, or drink fruit||
0309|075|S|juice or non-diet soda. Tell your doctor right away about the||
0309|076|S|reaction and the use of this product. To help prevent low blood||
0309|077|S|sugar, eat meals on a regular schedule, and do not skip meals.||
0309|078|S|Check with your doctor or pharmacist to find out what you should||
0309|079|S|do if you miss a meal.||
0309|080|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0309|081|S|thirst/urination. If these symptoms occur, tell your doctor right||
0309|082|S|away. Your doctor may need to adjust your diabetes medication,||
0309|083|S|exercise program, or diet.||
0309|084|S|   Get medical help right away if you have any very serious side||
0309|085|S|effects, including: symptoms of a heart attack (such as||
0309|086|S|chest/jaw/left arm pain, shortness of breath, unusual sweating).||
0309|087|S|   A very serious allergic reaction to this drug is rare.||
0309|088|S|However, get medical help right away if you notice any symptoms||
0309|089|S|of a serious allergic reaction, including: rash, itching/swelling||
0309|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0309|091|S|breathing.||
0309|092|S|   This is not a complete list of possible side effects. If you||
0309|093|S|notice other effects not listed above, contact your doctor or||
0309|094|S|pharmacist.||
0309|095|S|   In the US -||
0309|096|S|   Call your doctor for medical advice about side effects. You||
0309|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0309|098|S|www.fda.gov/medwatch.||
0309|099|S|   In Canada - Call your doctor for medical advice about side||
0309|100|S|effects. You may report side effects to Health Canada at||
0309|101|S|1-866-234-2345.||
0309|102|B|||
0309|103|P|PRECAUTIONS:  Before taking rosiglitazone, tell your doctor or||
0309|104|P|pharmacist if you are allergic to it; or to other glitazones such||
0309|105|P|as pioglitazone; or if you have any other allergies. This product||
0309|106|P|may contain inactive ingredients, which can cause allergic||
0309|107|P|reactions or other problems. Talk to your pharmacist for more||
0309|108|P|details.||
0309|109|P|   Before using this medication, tell your doctor or pharmacist||
0309|110|P|your medical history, especially of: liver disease, heart disease||
0309|111|P|(such as heart failure, heart attack, angina), fluid in the||
0309|112|P|lungs, swelling (edema), anemia, eye (retina) problems, bone||
0309|113|P|problems (such as osteoporosis, osteopenia).||
0309|114|P|   You may experience blurred vision, dizziness, or drowsiness||
0309|115|P|due to extremely low or high blood sugar. Do not drive, use||
0309|116|P|machinery, or do anything that needs alertness or clear vision||
0309|117|P|until you can do it safely.||
0309|118|P|   Limit alcohol while taking this medication because it can||
0309|119|P|increase your risk of developing low blood sugar.||
0309|120|P|   It may be harder to control your blood sugar when your body is||
0309|121|P|stressed (such as due to fever, infection, injury, or surgery).||
0309|122|P|Consult your doctor because this may require a change in your||
0309|123|P|treatment plan, medications, or blood sugar testing.||
0309|124|P|   Before having surgery, tell your doctor or dentist about all||
0309|125|P|the products you use (including prescription drugs,||
0309|126|P|nonprescription drugs, and herbal products).||
0309|127|P|   This medication may increase the risk of bone fracture||
0309|128|P|(usually in the upper arm, hand, or foot), especially in women.||
0309|129|P|See also Notes section.||
0309|130|P|   This medication can cause changes in a woman's menstrual cycle||
0309|131|P|(promote ovulation) and increase the chance of pregnancy. Consult||
0309|132|P|your doctor or pharmacist about using reliable birth control||
0309|133|P|while taking this medication.||
0309|134|P|   During pregnancy, this medication should be used only when||
0309|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
0309|136|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
0309|137|P|your doctor for managing your blood sugar while pregnant. Your||
0309|138|P|doctor may change your diabetes treatment during your pregnancy||
0309|139|P|(such as diet and medications including insulin).||
0309|140|P|   It is unknown if this medication passes into breast milk.||
0309|141|P|Consult your doctor before breastfeeding.||
0309|142|B|||
0309|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0309|144|I|medications work or increase your risk for serious side effects.||
0309|145|I|This document does not contain all possible drug interactions.||
0309|146|I|Keep a list of all the products you use (including||
0309|147|I|prescription/nonprescription drugs and herbal products) and share||
0309|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
0309|149|I|the dosage of any medicines without your doctor's approval.||
0309|150|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0309|151|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0309|152|I|heartbeat you would usually feel when your blood sugar falls too||
0309|153|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0309|154|I|dizziness, hunger, or sweating, are not affected by these drugs.||
0309|155|I|   Many drugs can affect your blood sugar, making it harder to||
0309|156|I|control. Before you start, stop, or change any medication, talk||
0309|157|I|with your doctor or pharmacist about how the medication may||
0309|158|I|affect your blood sugar. Check your blood sugar regularly as||
0309|159|I|directed by your doctor. Tell your doctor about the results and||
0309|160|I|of any symptoms of high or low blood sugar. (See also Side||
0309|161|I|Effects section.) Your doctor may need to adjust your diabetes||
0309|162|I|medication, exercise program, or diet.||
0309|163|B|||
0309|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0309|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0309|166|O|poison control center right away. US residents can call||
0309|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0309|168|B|||
0309|169|N|NOTES:  Do not share this medication with others.||
0309|170|N|   Attend a diabetes education program to learn more about||
0309|171|N|diabetes and the important aspects of its treatment, including||
0309|172|N|medications, diet, exercise, and getting regular eye/foot/medical||
0309|173|N|exams.||
0309|174|N|   Learn the symptoms of high and low blood sugar and how to||
0309|175|N|treat low blood sugar. Check your blood sugar regularly as||
0309|176|N|directed.||
0309|177|N|   Lifestyle changes that help promote healthy bones include||
0309|178|N|increasing weight-bearing exercise, stopping smoking, limiting||
0309|179|N|alcohol, and eating well-balanced meals that contain adequate||
0309|180|N|calcium and vitamin D. You may also need to take calcium and||
0309|181|N|vitamin D supplements. Consult your doctor for specific advice.||
0309|182|N|   Lab tests (such as liver/kidney function, fasting blood||
0309|183|N|glucose, hemoglobin A1c, complete blood counts, cholesterol||
0309|184|N|levels) should be done before you start taking this medication||
0309|185|N|and while you are taking it. Keep all medical and lab||
0309|186|N|appointments.||
0309|187|B|||
0309|188|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0309|189|D|remember. If it is near the time of the next dose, skip the||
0309|190|D|missed dose. Take your next dose at the regular time. Do not||
0309|191|D|double the dose to catch up.||
0309|192|B|||
0309|193|R|STORAGE:  Store at room temperature away from light and moisture.||
0309|194|R|Do not store in the bathroom. Keep all medications away from||
0309|195|R|children and pets.||
0309|196|R|   Do not flush medications down the toilet or pour them into a||
0309|197|R|drain unless instructed to do so. Properly discard this product||
0309|198|R|when it is expired or no longer needed. Consult your pharmacist||
0309|199|R|or local waste disposal company.||
0309|200|B|||
0309|201|M|MEDICAL ALERT:  Your condition can cause complications in a||
0309|202|M|medical emergency. For information about enrolling in MedicAlert,||
0309|203|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0309|204|B|||
0309|205|A|Information last revised April 2025.||
0309|206|A|Copyright(c) 2025 First Databank, Inc.||
0309|207|B|||
0310|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0310|002|Z|does NOT have all possible information about this product. This||
0310|003|Z|information does not assure that this product is safe, effective,||
0310|004|Z|or appropriate for you. This information is not individual||
0310|005|Z|medical advice and does not substitute for the advice of your||
0310|006|Z|health care professional. Always ask your health care||
0310|007|Z|professional for complete information about this product and your||
0310|008|Z|specific health needs.||
0310|009|B|||
0310|010|T|RISEDRONATE - ORAL||
0310|011|F|(RIS-e-DROE-nate)||
0310|012|B|||
0310|013|C|COMMON BRAND NAME(S): Actonel||
0310|014|B|||
0310|015|U|USES:  Risedronate is used to prevent and treat certain types of||
0310|016|U|bone loss (osteoporosis) in adults. Osteoporosis causes bones to||
0310|017|U|become thinner and break more easily. Your chance of developing||
0310|018|U|osteoporosis increases as you age, after menopause, or if you are||
0310|019|U|taking corticosteroid medications (such as prednisone) for long||
0310|020|U|periods of time.||
0310|021|U|   This medication works by slowing bone loss to help maintain||
0310|022|U|strong bones and reduce the risk of broken bones (fractures).||
0310|023|U|Risedronate belongs to a class of medications called||
0310|024|U|bisphosphonates.||
0310|025|B|||
0310|026|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0310|027|H|Patient Information Leaflet provided by your pharmacist before||
0310|028|H|you start using risedronate and each time you get a refill.||
0310|029|H|Follow the instructions very closely to make sure you absorb as||
0310|030|H|much of the drug as possible and reduce the risk of injury to||
0310|031|H|your esophagus. If you have any questions, ask your doctor or||
0310|032|H|pharmacist.||
0310|033|H|   Take this medication by mouth as directed by your doctor,||
0310|034|H|usually once a day. Take it after getting up for the day and||
0310|035|H|before taking your first food, beverage or other medication. Do||
0310|036|H|not take it at bedtime or while you are still in bed.||
0310|037|H|   Take this medication with a full glass of plain water (6 to 8||
0310|038|H|ounces or 180 to 240 milliliters). Do not take it with any other||
0310|039|H|beverage. Swallow the tablet whole. Do not chew or suck on it.||
0310|040|H|Then stay fully upright (sitting, standing or walking) for at||
0310|041|H|least 30 minutes, and do not lie down until after your first food||
0310|042|H|of the day. Wait at least 30 minutes after taking risedronate||
0310|043|H|before you eat or drink anything other than plain water and||
0310|044|H|before taking any other medication by mouth.||
0310|045|H|   Calcium or iron supplements, vitamins with minerals, antacids||
0310|046|H|containing calcium/magnesium/aluminum, dairy products (such as||
0310|047|H|milk, yogurt), and juice with added calcium may interfere with||
0310|048|H|absorption of risedronate. Medications such as quinapril,||
0310|049|H|sucralfate, and bismuth subsalicylate may also interfere with||
0310|050|H|absorption. Do not take these products for at least 30 minutes||
0310|051|H|after taking risedronate.||
0310|052|H|   Use this medication regularly in order to get the most benefit||
0310|053|H|from it. Remember to take it at the same time each morning. Talk||
0310|054|H|to your doctor about the risks and benefits of long-term use of||
0310|055|H|this medication.||
0310|056|B|||
0310|057|S|SIDE EFFECTS:  Upset stomach may occur. If this effect lasts or||
0310|058|S|gets worse, tell your doctor or pharmacist promptly.||
0310|059|S|   Remember that this medication has been prescribed because your||
0310|060|S|doctor has judged that the benefit to you is greater than the||
0310|061|S|risk of side effects. Many people using this medication do not||
0310|062|S|have serious side effects.||
0310|063|S|   Tell your doctor right away if you have any serious side||
0310|064|S|effects, including: increased or severe bone/joint/muscle pain,||
0310|065|S|new or unusual hip/thigh/groin pain, jaw pain, eye/vision||
0310|066|S|problems.||
0310|067|S|   This medication may rarely cause irritation and ulcers in your||
0310|068|S|stomach or esophagus. Get medical help right away if any of these||
0310|069|S|serious side effects occur: new/severe/worsening heartburn, chest||
0310|070|S|pain, difficult or painful swallowing, severe stomach/abdominal||
0310|071|S|pain, black/tarry stools, vomit that looks like coffee grounds.||
0310|072|S|   A very serious allergic reaction to this drug is rare.||
0310|073|S|However, get medical help right away if you notice any symptoms||
0310|074|S|of a serious allergic reaction, including: rash, itching/swelling||
0310|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0310|076|S|breathing.||
0310|077|S|   This is not a complete list of possible side effects. If you||
0310|078|S|notice other effects not listed above, contact your doctor or||
0310|079|S|pharmacist.||
0310|080|S|   In the US -||
0310|081|S|   Call your doctor for medical advice about side effects. You||
0310|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0310|083|S|www.fda.gov/medwatch.||
0310|084|S|   In Canada - Call your doctor for medical advice about side||
0310|085|S|effects. You may report side effects to Health Canada at||
0310|086|S|1-866-234-2345.||
0310|087|B|||
0310|088|P|PRECAUTIONS:  Before taking risedronate, tell your doctor or||
0310|089|P|pharmacist if you are allergic to it; or to other bisphosphonates||
0310|090|P|(such as alendronate, etidronate, pamidronate); or if you have||
0310|091|P|any other allergies. This product may contain inactive||
0310|092|P|ingredients, which can cause allergic reactions or other||
0310|093|P|problems. Talk to your pharmacist for more details.||
0310|094|P|   Before using this medication, tell your doctor or pharmacist||
0310|095|P|your medical history, especially of: esophagus problems (such as||
0310|096|P|esophageal stricture, achalasia), difficult or painful||
0310|097|P|swallowing, low blood calcium levels (hypocalcemia), inability to||
0310|098|P|sit upright or stand for at least 30 minutes, severe kidney||
0310|099|P|disease, stomach/intestinal disorders (such as ulcers).||
0310|100|P|   Some people taking risedronate may have serious jawbone||
0310|101|P|problems. Your doctor should check your mouth before you start||
0310|102|P|this medication. Tell your dentist that you are taking this||
0310|103|P|medication before you have any dental work done. To help prevent||
0310|104|P|jawbone problems, have regular dental exams and learn how to keep||
0310|105|P|your teeth and gums healthy. If you have jaw pain, tell your||
0310|106|P|doctor and dentist right away.||
0310|107|P|   Before having any surgery (especially dental procedures), tell||
0310|108|P|your doctor and dentist about this medication and all other||
0310|109|P|products you use (including prescription drugs, nonprescription||
0310|110|P|drugs, and herbal products). Your doctor or dentist may tell you||
0310|111|P|to stop taking risedronate before your surgery. Ask for specific||
0310|112|P|instructions about stopping or starting this medication.||
0310|113|P|   Tell your doctor if you are pregnant or plan to become||
0310|114|P|pregnant. Risedronate may stay in your body for many years. You||
0310|115|P|should not become pregnant while using risedronate. Discuss the||
0310|116|P|risks and benefits with your doctor.||
0310|117|P|   It is unknown if this drug passes into breast milk. Consult||
0310|118|P|your doctor before breastfeeding.||
0310|119|B|||
0310|120|I|DRUG INTERACTIONS:  See also How to Use section.||
0310|121|I|   Drug interactions may change how your medications work or||
0310|122|I|increase your risk for serious side effects. This document does||
0310|123|I|not contain all possible drug interactions. Keep a list of all||
0310|124|I|the products you use (including prescription/nonprescription||
0310|125|I|drugs and herbal products) and share it with your doctor and||
0310|126|I|pharmacist. Do not start, stop, or change the dosage of any||
0310|127|I|medicines without your doctor's approval.||
0310|128|I|   This medication may interfere with certain lab tests (such as||
0310|129|I|bone-imaging tests), possibly causing false test results. Make||
0310|130|I|sure lab personnel and all your doctors know you use this drug.||
0310|131|B|||
0310|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0310|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0310|134|O|poison control center right away. US residents can call||
0310|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0310|136|B|||
0310|137|N|NOTES:  Do not share this medication with others.||
0310|138|N|   Lifestyle changes that help promote healthy bones include||
0310|139|N|increasing weight-bearing exercise, stopping smoking, limiting||
0310|140|N|alcohol, and eating well-balanced meals that contain adequate||
0310|141|N|calcium and vitamin D. Since you may also need to take calcium||
0310|142|N|and vitamin D supplements and make lifestyle changes, consult||
0310|143|N|your doctor for specific advice.||
0310|144|N|   Lab and/or medical tests (x-rays, height, blood mineral||
0310|145|N|levels) should be done while you are taking this medication. Keep||
0310|146|N|all medical and lab appointments. Consult your doctor for more||
0310|147|N|details.||
0310|148|B|||
0310|149|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Do not||
0310|150|D|take it later in the day. Take your next dose at the regular time||
0310|151|D|the following day. Do not double the dose to catch up.||
0310|152|B|||
0310|153|R|STORAGE:  Store at room temperature away from light and moisture.||
0310|154|R|Do not store in the bathroom. Keep all medications away from||
0310|155|R|children and pets.||
0310|156|R|   Do not flush medications down the toilet or pour them into a||
0310|157|R|drain unless instructed to do so. Properly discard this product||
0310|158|R|when it is expired or no longer needed. Consult your pharmacist||
0310|159|R|or local waste disposal company.||
0310|160|B|||
0310|161|A|Information last revised September 2025.||
0310|162|A|Copyright(c) 2025 First Databank, Inc.||
0310|163|B|||
0311|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0311|002|Z|does NOT have all possible information about this product. This||
0311|003|Z|information does not assure that this product is safe, effective,||
0311|004|Z|or appropriate for you. This information is not individual||
0311|005|Z|medical advice and does not substitute for the advice of your||
0311|006|Z|health care professional. Always ask your health care||
0311|007|Z|professional for complete information about this product and your||
0311|008|Z|specific health needs.||
0311|009|B|||
0311|010|T|ECHINACEA (Echinacea sp.) - ORAL||
0311|011|B|||
0311|012|U|USES:  Echinacea has been used for virus infections such as the||
0311|013|U|common cold and flu. It is used to strengthen the immune system.||
0311|014|U|It has also been used for returning vaginal fungal infections||
0311|015|U|("yeast infections") along with antifungal products applied to||
0311|016|U|the vaginal area.||
0311|017|U|   Some herbal/diet supplement products have been found to||
0311|018|U|contain possibly harmful impurities/additives. Check with your||
0311|019|U|pharmacist for more details about the brand you use.||
0311|020|U|   The FDA has not reviewed this product for safety or||
0311|021|U|effectiveness. Consult your doctor or pharmacist for more||
0311|022|U|details.||
0311|023|B|||
0311|024|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
0311|025|H|directions on the product package. If you have any questions, ask||
0311|026|H|your doctor or pharmacist.||
0311|027|H|   This product may increase the effects of caffeine. Avoid||
0311|028|H|drinking large amounts of beverages containing caffeine (coffee,||
0311|029|H|tea, colas), eating large amounts of chocolate, or taking||
0311|030|H|nonprescription products that contain caffeine.||
0311|031|H|   Prolonged use may lessen the effects of this product. It is||
0311|032|H|recommended that this product be used for no more than 8 weeks at||
0311|033|H|a time.||
0311|034|H|   If your condition lasts or gets worse, or if you think you may||
0311|035|H|have a serious medical problem, get medical help right away.||
0311|036|B|||
0311|037|S|SIDE EFFECTS:  Nausea, numbness/tingling of the lips/tongue, and||
0311|038|S|an unpleasant taste in the mouth may occur. If these effects last||
0311|039|S|or get worse, tell your doctor.||
0311|040|S|   A very serious allergic reaction to this product is rare.||
0311|041|S|However, get medical help right away if you notice any symptoms||
0311|042|S|of a serious allergic reaction, including: rash, itching/swelling||
0311|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0311|044|S|breathing.||
0311|045|S|   This is not a complete list of possible side effects. If you||
0311|046|S|notice other effects not listed above, contact your doctor or||
0311|047|S|pharmacist.||
0311|048|S|   In the US -||
0311|049|S|   Call your doctor for medical advice about side effects. You||
0311|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0311|051|S|www.fda.gov/medwatch.||
0311|052|S|   In Canada - Call your doctor for medical advice about side||
0311|053|S|effects. You may report side effects to Health Canada at||
0311|054|S|1-866-234-2345.||
0311|055|B|||
0311|056|P|PRECAUTIONS:  Before taking echinacea, tell your doctor or||
0311|057|P|pharmacist if you are allergic to it; or to plants in the||
0311|058|P|Asteraceae/daisy family such as ragweed, chrysanthemums,||
0311|059|P|marigolds, and daisies; or if you have any other allergies. This||
0311|060|P|product may contain inactive ingredients, which can cause||
0311|061|P|allergic reactions or other problems. Talk to your pharmacist for||
0311|062|P|more details.||
0311|063|P|   If you have any of the following health problems, consult your||
0311|064|P|doctor or pharmacist before using this product: asthma, cancer,||
0311|065|P|immune system problems (autoimmune disorders such as multiple||
0311|066|P|sclerosis, rheumatoid arthritis, lupus), infection with HIV or||
0311|067|P|tuberculosis, organ transplant.||
0311|068|P|   Liquid forms of this product may contain sugar and/or alcohol.||
0311|069|P|Caution is advised if you have diabetes, alcohol dependence, or||
0311|070|P|liver disease. Ask your doctor or pharmacist about using this||
0311|071|P|product safely. If there is alcohol in this product, it may make||
0311|072|P|you dizzy or drowsy. Marijuana (cannabis) can make you more dizzy||
0311|073|P|or drowsy. Do not drive, use machinery, or do anything that needs||
0311|074|P|alertness until you can do it safely. Limit alcoholic beverages.||
0311|075|P|Talk to your doctor if you are using marijuana (cannabis).||
0311|076|P|   During pregnancy, this product should be used only when||
0311|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
0311|078|P|   It is unknown if this product passes into breast milk. Consult||
0311|079|P|your doctor before breastfeeding.||
0311|080|B|||
0311|081|I|DRUG INTERACTIONS:  See also How to Use section.||
0311|082|I|   Drug interactions may change how your medications work or||
0311|083|I|increase your risk for serious side effects. This document does||
0311|084|I|not contain all possible drug interactions. Keep a list of all||
0311|085|I|the products you use (including prescription/nonprescription||
0311|086|I|drugs and herbal products) and share it with your doctor and||
0311|087|I|pharmacist. Do not start, stop, or change the dosage of any||
0311|088|I|medicines without your doctor's approval.||
0311|089|I|   This product can slow down the removal of other medications||
0311|090|I|from your body, which may affect how they work. An example of an||
0311|091|I|affected drug is fezolinetant, among others.||
0311|092|B|||
0311|093|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0311|094|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0311|095|O|poison control center right away. US residents can call||
0311|096|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0311|097|B|||
0311|098|N|NOTES:  Keep all medical and lab appointments.||
0311|099|B|||
0311|100|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0311|101|D|remember. If it is near the time of the next dose, skip the||
0311|102|D|missed dose. Take your next dose at the regular time. Do not||
0311|103|D|double the dose to catch up.||
0311|104|B|||
0311|105|R|STORAGE:  Refer to storage information printed on the package. If||
0311|106|R|you have any questions about storage, ask your pharmacist. Keep||
0311|107|R|all medications and herbal products away from children and pets.||
0311|108|R|   Do not flush medications down the toilet or pour them into a||
0311|109|R|drain unless instructed to do so. Properly discard this product||
0311|110|R|when it is expired or no longer needed. Consult your pharmacist||
0311|111|R|or local waste disposal company.||
0311|112|B|||
0311|113|A|Information last revised July 2025.||
0311|114|A|Copyright(c) 2025 First Databank, Inc.||
0311|115|B|||
0314|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0314|002|Z|does NOT have all possible information about this product. This||
0314|003|Z|information does not assure that this product is safe, effective,||
0314|004|Z|or appropriate for you. This information is not individual||
0314|005|Z|medical advice and does not substitute for the advice of your||
0314|006|Z|health care professional. Always ask your health care||
0314|007|Z|professional for complete information about this product and your||
0314|008|Z|specific health needs.||
0314|009|B|||
0314|010|T|KAVA (Piper methysticum) - ORAL||
0314|011|B|||
0314|012|W|WARNING:  This product may rarely cause serious (possibly fatal)||
0314|013|W|liver disease. Stop taking this product and consult your doctor||
0314|014|W|right away if you develop symptoms of liver injury, including||
0314|015|W|nausea that doesn't stop, loss of appetite, unusual tiredness,||
0314|016|W|stomach/abdominal pain, pale stools, dark urine, yellowing||
0314|017|W|eyes/skin. Using this product for a long time or in high doses,||
0314|018|W|using certain other drugs that may harm the liver along with this||
0314|019|W|product, current/previous liver problems, and drinking alcoholic||
0314|020|W|beverages may increase your risk of serious liver problems. See||
0314|021|W|also Drug Interactions section.||
0314|022|B|||
0314|023|U|USES:  Kava has been used for anxiety and stress. The US Food and||
0314|024|U|Drug Administration (FDA) has issued a public safety alert about||
0314|025|U|kava and liver problems.||
0314|026|U|   Some herbal/diet supplement products have been found to||
0314|027|U|contain possibly harmful impurities/additives. Check with your||
0314|028|U|pharmacist for more details regarding the particular brand you||
0314|029|U|use.||
0314|030|U|   The FDA has not reviewed this product for safety or||
0314|031|U|effectiveness. Consult your doctor or pharmacist for more||
0314|032|U|details.||
0314|033|B|||
0314|034|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
0314|035|H|directions on the product package. If you have any questions, ask||
0314|036|H|your doctor or pharmacist.||
0314|037|H|   This herbal product should not be used for more than 3 months||
0314|038|H|at a time.||
0314|039|H|   If your condition lasts or gets worse, or if you think you may||
0314|040|H|have a serious medical problem, get medical help right away.||
0314|041|B|||
0314|042|S|SIDE EFFECTS:  See also Warning section.||
0314|043|S|   Nausea, dizziness, drowsiness, headache, mouth numbness, or||
0314|044|S|blurred vision may occur. If any of these effects last or get||
0314|045|S|worse, tell your doctor right away.||
0314|046|S|   Tell your doctor right away if you have any serious side||
0314|047|S|effects, including: muscle spasm/stiffness/weakness, uncontrolled||
0314|048|S|movements (especially of lips and tongue), loss of coordination,||
0314|049|S|shakiness (tremor), easy bleeding/bruising, weight loss, red/pink||
0314|050|S|urine.||
0314|051|S|   Taking kava continuously for a long time may cause reddened||
0314|052|S|eyes, dry/scaly skin, or yellowing hair/skin/nails. These||
0314|053|S|symptoms usually disappear when kava is stopped. Stop taking kava||
0314|054|S|right away if you develop any of these symptoms. Yellowing skin||
0314|055|S|may also be a sign of liver problems. Get medical help right away||
0314|056|S|if you develop yellowing eyes/skin.||
0314|057|S|   A very serious allergic reaction to this product is rare.||
0314|058|S|However, get medical help right away if you notice any symptoms||
0314|059|S|of a serious allergic reaction, including: rash, itching/swelling||
0314|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0314|061|S|breathing.||
0314|062|S|   This is not a complete list of possible side effects. If you||
0314|063|S|notice other effects not listed above, contact your doctor or||
0314|064|S|pharmacist.||
0314|065|S|   In the US -||
0314|066|S|   Call your doctor for medical advice about side effects. You||
0314|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0314|068|S|www.fda.gov/medwatch.||
0314|069|S|   In Canada - Call your doctor for medical advice about side||
0314|070|S|effects. You may report side effects to Health Canada at||
0314|071|S|1-866-234-2345.||
0314|072|B|||
0314|073|P|PRECAUTIONS:  Before taking kava, tell your doctor or pharmacist||
0314|074|P|if you are allergic to it; or if you have any other allergies.||
0314|075|P|This product may contain inactive ingredients, which can cause||
0314|076|P|allergic reactions or other problems. Talk to your pharmacist for||
0314|077|P|more details.||
0314|078|P|   If you have any of the following health problems, consult your||
0314|079|P|doctor or pharmacist before using this product: depression,||
0314|080|P|past/current liver disease, Parkinson's disease.||
0314|081|P|   This drug may make you dizzy or drowsy or blur your vision.||
0314|082|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0314|083|P|drowsy. Do not drive, use machinery, or do anything that needs||
0314|084|P|alertness or clear vision until you can do it safely. Avoid||
0314|085|P|alcoholic beverages. Alcohol may also increase the risk of||
0314|086|P|serious liver problems. Talk to your doctor if you are using||
0314|087|P|marijuana (cannabis).||
0314|088|P|   Liquid forms of this product may contain sugar and/or alcohol.||
0314|089|P|Caution is advised if you have diabetes, alcohol dependence, or||
0314|090|P|liver disease. Ask your doctor or pharmacist about using this||
0314|091|P|product safely.||
0314|092|P|   Before having surgery, tell your doctor or dentist about all||
0314|093|P|the products you use (including prescription drugs,||
0314|094|P|nonprescription drugs, and herbal products).||
0314|095|P|   Tell your doctor if you are pregnant or plan to become||
0314|096|P|pregnant. You should not become pregnant while using kava. Kava||
0314|097|P|may harm an unborn baby. If you become pregnant, talk to your||
0314|098|P|doctor right away about the risks and benefits of this||
0314|099|P|medication.||
0314|100|P|   It is unknown if this product passes into breast milk. Consult||
0314|101|P|your doctor before breastfeeding.||
0314|102|B|||
0314|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0314|104|I|medications work or increase your risk for serious side effects.||
0314|105|I|This document does not contain all possible drug interactions.||
0314|106|I|Keep a list of all the products you use (including||
0314|107|I|prescription/nonprescription drugs and herbal products) and share||
0314|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
0314|109|I|the dosage of any medicines without your doctor's approval.||
0314|110|I|   Some drugs that may interact with this product include: drugs||
0314|111|I|that can harm the liver (including acetaminophen, amiodarone,||
0314|112|I|isoniazid, methotrexate, methyldopa, "statins" such as||
0314|113|I|atorvastatin and lovastatin), "blood thinners" (such as||
0314|114|I|warfarin).||
0314|115|I|   Tell your doctor or pharmacist if you are taking other||
0314|116|I|products that cause drowsiness such as opioid pain or cough||
0314|117|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0314|118|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0314|119|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0314|120|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0314|121|I|diphenhydramine).||
0314|122|I|   Check the labels on all your medicines (such as allergy or||
0314|123|I|cough-and-cold products) because they may contain ingredients||
0314|124|I|that cause drowsiness. Ask your pharmacist about using those||
0314|125|I|products safely.||
0314|126|B|||
0314|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0314|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0314|129|O|poison control center right away. US residents can call||
0314|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0314|131|O|Symptoms of overdose may include: severe drowsiness, inability to||
0314|132|O|move.||
0314|133|B|||
0314|134|N|NOTES:  Tell your doctor that you are taking kava. Lab and/or||
0314|135|N|medical tests (such as liver function) may be done while you are||
0314|136|N|taking this product. Keep all medical and lab appointments.||
0314|137|B|||
0314|138|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0314|139|D|remember. If it is near the time of the next dose, skip the||
0314|140|D|missed dose. Take your next dose at the regular time. Do not||
0314|141|D|double the dose to catch up.||
0314|142|B|||
0314|143|R|STORAGE:  Refer to storage information printed on the package. If||
0314|144|R|you have any questions about storage, ask your pharmacist. Keep||
0314|145|R|all medications and herbal products away from children and pets.||
0314|146|R|   Do not flush medications down the toilet or pour them into a||
0314|147|R|drain unless instructed to do so. Properly discard this product||
0314|148|R|when it is expired or no longer needed. Consult your pharmacist||
0314|149|R|or local waste disposal company.||
0314|150|B|||
0314|151|A|Information last revised January 2025.||
0314|152|A|Copyright(c) 2025 First Databank, Inc.||
0314|153|B|||
0319|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0319|002|Z|does NOT have all possible information about this product. This||
0319|003|Z|information does not assure that this product is safe, effective,||
0319|004|Z|or appropriate for you. This information is not individual||
0319|005|Z|medical advice and does not substitute for the advice of your||
0319|006|Z|health care professional. Always ask your health care||
0319|007|Z|professional for complete information about this product and your||
0319|008|Z|specific health needs.||
0319|009|B|||
0319|010|T|ALOSETRON - ORAL||
0319|011|F|(al-OH-se-tron)||
0319|012|B|||
0319|013|C|COMMON BRAND NAME(S): Lotronex||
0319|014|B|||
0319|015|W|WARNING:  Alosetron has rarely caused serious, sometimes fatal||
0319|016|W|side effects of the intestines. These effects include reduced||
0319|017|W|blood flow to the large intestine (ischemic colitis) and serious||
0319|018|W|complications of constipation. If you have constipation, new or||
0319|019|W|worsening stomach/abdominal pain, or bloody diarrhea/stools, stop||
0319|020|W|taking this medication and get medical help right away. If your||
0319|021|W|constipation does not go away after stopping alosetron, again||
0319|022|W|tell your doctor right away. Do not take this medication again||
0319|023|W|unless your doctors tells you to do so.||
0319|024|W|   This medication should only be used by women with severe||
0319|025|W|irritable bowel syndrome (IBS) whose main problem is diarrhea.||
0319|026|W|Only carefully selected patients may use this medication. Consult||
0319|027|W|your doctor or pharmacist for more information about the risks||
0319|028|W|and benefits of using alosetron.||
0319|029|B|||
0319|030|U|USES:  Alosetron is used to treat women with severe irritable||
0319|031|U|bowel syndrome (IBS) who have diarrhea as the main problem. It is||
0319|032|U|not a cure, but it may help to decrease abdominal pain, sudden||
0319|033|U|urges to have a bowel movement, and diarrhea.||
0319|034|U|   This medication is not recommended for use by children because||
0319|035|U|of the serious side effects that have been seen in adults.||
0319|036|B|||
0319|037|H|HOW TO USE:  Read the Medication Guide provided by your||
0319|038|H|pharmacist before you start taking alosetron and each time you||
0319|039|H|get a refill. If you have any questions, ask your doctor or||
0319|040|H|pharmacist.||
0319|041|H|   Take this medication by mouth with or without food as directed||
0319|042|H|by your doctor, usually once or twice daily. The dosage is based||
0319|043|H|on your medical condition and response to treatment. Do not start||
0319|044|H|taking this medication if you are constipated.||
0319|045|H|   Tell your doctor if your condition does not get better or if||
0319|046|H|it gets worse.||
0319|047|B|||
0319|048|S|SIDE EFFECTS:  See also Warning section.||
0319|049|S|   Remember that this medication has been prescribed because your||
0319|050|S|doctor has judged that the benefit to you is greater than the||
0319|051|S|risk of side effects. Many people using this medication do not||
0319|052|S|have serious side effects.||
0319|053|S|   Stop taking this medication and get medical help right away if||
0319|054|S|any of these very serious side effects occur: constipation,||
0319|055|S|bloody diarrhea/stools, new or worsening stomach/abdominal pain.||
0319|056|S|   This medication may increase serotonin and rarely cause a very||
0319|057|S|serious condition called serotonin syndrome/toxicity. The risk||
0319|058|S|increases if you are also taking other drugs that increase||
0319|059|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0319|060|S|take (see Drug Interactions section). Get medical help right away||
0319|061|S|if you develop some of the following symptoms: fast heartbeat,||
0319|062|S|hallucinations, loss of coordination, severe dizziness, severe||
0319|063|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0319|064|S|unusual agitation/restlessness.||
0319|065|S|   A very serious allergic reaction to this drug is rare.||
0319|066|S|However, get medical help right away if you notice any symptoms||
0319|067|S|of a serious allergic reaction, such as: rash, itching/swelling||
0319|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0319|069|S|breathing.||
0319|070|S|   This is not a complete list of possible side effects. If you||
0319|071|S|notice other effects not listed above, contact your doctor or||
0319|072|S|pharmacist.||
0319|073|S|   In the US -||
0319|074|S|   Call your doctor for medical advice about side effects. You||
0319|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0319|076|S|www.fda.gov/medwatch.||
0319|077|S|   In Canada - Call your doctor for medical advice about side||
0319|078|S|effects. You may report side effects to Health Canada at||
0319|079|S|1-866-234-2345.||
0319|080|B|||
0319|081|P|PRECAUTIONS:  Before taking alosetron, tell your doctor or||
0319|082|P|pharmacist if you are allergic to it; or if you have any other||
0319|083|P|allergies. This product may contain inactive ingredients, which||
0319|084|P|can cause allergic reactions or other problems. Talk to your||
0319|085|P|pharmacist for more details.||
0319|086|P|   Before using this medication, tell your doctor or pharmacist||
0319|087|P|your medical history, especially of: constipation, other||
0319|088|P|bowel/intestinal disorders (such as bowel blockage, ischemic||
0319|089|P|colitis, Crohn's disease, ulcerative colitis, diverticulitis),||
0319|090|P|liver disease, blood clots.||
0319|091|P|   Before having surgery, tell your doctor or dentist about all||
0319|092|P|the products you use (such as prescription drugs, nonprescription||
0319|093|P|drugs, and herbal products).||
0319|094|P|   Older adults may be more sensitive to the side effects of this||
0319|095|P|drug, especially constipation.||
0319|096|P|   During pregnancy, this medication should be used only when||
0319|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
0319|098|P|   It is unknown if this drug passes into breast milk. Consult||
0319|099|P|your doctor before breastfeeding.||
0319|100|B|||
0319|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0319|102|I|medications work or increase your risk for serious side effects.||
0319|103|I|This document does not contain all possible drug interactions.||
0319|104|I|Keep a list of all the products you use (such as||
0319|105|I|prescription/nonprescription drugs and herbal products) and share||
0319|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
0319|107|I|the dosage of any medicines without your doctor's approval.||
0319|108|I|   A product that may interact with this drug is: apomorphine.||
0319|109|I|   Other medications can affect the removal of alosetron from||
0319|110|I|your body, which may affect how alosetron works. Examples include||
0319|111|I|enasidenib, fluvoxamine, viloxazine, among others||
0319|112|I|   The risk of serious complications of constipation increases if||
0319|113|I|you are also taking other drugs that may cause constipation. Ask||
0319|114|I|your doctor or pharmacist about the safe use of all the products||
0319|115|I|you may take.||
0319|116|I|   The risk of serotonin syndrome/toxicity increases if you are||
0319|117|I|also taking other drugs that increase serotonin. Some examples||
0319|118|I|are street drugs such as MDMA/ "ecstasy," St. John's wort,||
0319|119|I|certain antidepressants (such as SSRIs like||
0319|120|I|fluoxetine/paroxetine, SNRIs like duloxetine/venlafaxine), among||
0319|121|I|others. The risk of serotonin syndrome/toxicity may be more||
0319|122|I|likely when you start or increase the dose of these drugs.||
0319|123|B|||
0319|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0319|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0319|126|O|poison control center right away. US residents can call||
0319|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0319|128|B|||
0319|129|N|NOTES:  Do not share this medication with others.||
0319|130|B|||
0319|131|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0319|132|D|remember. If it is near the time of the next dose, skip the||
0319|133|D|missed dose. Take your next dose at the regular time. Do not||
0319|134|D|double the dose to catch up.||
0319|135|B|||
0319|136|R|STORAGE:  Store at room temperature away from light and moisture.||
0319|137|R|Do not store in the bathroom. Keep all medications away from||
0319|138|R|children and pets.||
0319|139|R|   Do not flush medications down the toilet or pour them into a||
0319|140|R|drain unless instructed to do so. Properly discard this product||
0319|141|R|when it is expired or no longer needed. Consult your pharmacist||
0319|142|R|or local waste disposal company.||
0319|143|B|||
0319|144|A|Information last revised July 2025.||
0319|145|A|Copyright(c) 2025 First Databank, Inc.||
0319|146|B|||
0322|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0322|002|Z|does NOT have all possible information about this product. This||
0322|003|Z|information does not assure that this product is safe, effective,||
0322|004|Z|or appropriate for you. This information is not individual||
0322|005|Z|medical advice and does not substitute for the advice of your||
0322|006|Z|health care professional. Always ask your health care||
0322|007|Z|professional for complete information about this product and your||
0322|008|Z|specific health needs.||
0322|009|B|||
0322|010|T|SUCCIMER - ORAL||
0322|011|F|(SUX-i-mer)||
0322|012|B|||
0322|013|C|COMMON BRAND NAME(S): Chemet||
0322|014|B|||
0322|015|U|USES:  This medication is used to treat lead poisoning. It works||
0322|016|U|by binding to the lead so that it may be removed by your kidneys.||
0322|017|U|Removing lead from your body will lower the chance of severe||
0322|018|U|problems caused by lead poisoning.||
0322|019|B|||
0322|020|H|HOW TO USE:  Take this medication by mouth with or without food||
0322|021|H|as directed by your doctor, usually every 8 or 12 hours. Swallow||
0322|022|H|the capsules whole. If you have trouble swallowing the capsule,||
0322|023|H|you may open the capsule and sprinkle the contents on soft food||
0322|024|H|(such as applesauce). Swallow all of the drug/food mixture right||
0322|025|H|away without chewing. You may also place the contents on a spoon||
0322|026|H|and swallow with fruit juice.||
0322|027|H|   The dosage and length of treatment is based on your medical||
0322|028|H|condition, response to treatment, and body size.||
0322|029|H|   Drink plenty of fluids while taking this medication unless||
0322|030|H|your doctor directs you otherwise.||
0322|031|H|   Use this medication regularly in order to get the most benefit||
0322|032|H|from it. To help you remember, take it at the same times each||
0322|033|H|day.||
0322|034|B|||
0322|035|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, or diarrhea||
0322|036|S|may occur. If any of these effects last or get worse, tell your||
0322|037|S|doctor or pharmacist promptly.||
0322|038|S|   Remember that this medication has been prescribed because your||
0322|039|S|doctor has judged that the benefit to you is greater than the||
0322|040|S|risk of side effects. Many people using this medication do not||
0322|041|S|have serious side effects.||
0322|042|S|   Tell your doctor right away if you have any serious side||
0322|043|S|effects, including: signs of infection (such as sore throat that||
0322|044|S|doesn't go away, fever, chills).||
0322|045|S|   A very serious allergic reaction to this drug is rare.||
0322|046|S|However, get medical help right away if you notice any symptoms||
0322|047|S|of a serious allergic reaction, including: rash, itching/swelling||
0322|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0322|049|S|breathing.||
0322|050|S|   This is not a complete list of possible side effects. If you||
0322|051|S|notice other effects not listed above, contact your doctor or||
0322|052|S|pharmacist.||
0322|053|S|   In the US -||
0322|054|S|   Call your doctor for medical advice about side effects. You||
0322|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0322|056|S|www.fda.gov/medwatch.||
0322|057|S|   In Canada - Call your doctor for medical advice about side||
0322|058|S|effects. You may report side effects to Health Canada at||
0322|059|S|1-866-234-2345.||
0322|060|B|||
0322|061|P|PRECAUTIONS:  Before taking succimer, tell your doctor or||
0322|062|P|pharmacist if you are allergic to it; or if you have any other||
0322|063|P|allergies. This product may contain inactive ingredients, which||
0322|064|P|can cause allergic reactions or other problems. Talk to your||
0322|065|P|pharmacist for more details.||
0322|066|P|   Before using this medication, tell your doctor or pharmacist||
0322|067|P|your medical history, especially of: kidney disease, liver||
0322|068|P|disease.||
0322|069|P|   Before having surgery, tell your doctor or dentist about all||
0322|070|P|the products you use (including prescription drugs,||
0322|071|P|nonprescription drugs, and herbal products).||
0322|072|P|   Tell your doctor if you are pregnant or plan to become||
0322|073|P|pregnant. You should not become pregnant while using succimer.||
0322|074|P|Succimer may harm an unborn baby. Your doctor should order a||
0322|075|P|pregnancy test before you start this medication. Ask about||
0322|076|P|reliable forms of birth control while using this medication and||
0322|077|P|for 14 days after the last dose. If you become pregnant, talk to||
0322|078|P|your doctor right away about the risks and benefits of this||
0322|079|P|medication.||
0322|080|P|   It is unknown if this medication passes into breast milk.||
0322|081|P|However, since this medication is used for lead poisoning and||
0322|082|P|lead may pass into breast milk, do not breastfeed while using||
0322|083|P|this drug.||
0322|084|B|||
0322|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0322|086|I|medications work or increase your risk for serious side effects.||
0322|087|I|This document does not contain all possible drug interactions.||
0322|088|I|Keep a list of all the products you use (including||
0322|089|I|prescription/nonprescription drugs and herbal products) and share||
0322|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
0322|091|I|the dosage of any medicines without your doctor's approval.||
0322|092|I|   This medication may interfere with certain lab tests (such as||
0322|093|I|uric acid levels, CPK levels, certain urine ketone tests),||
0322|094|I|possibly causing false test results. Make sure lab personnel and||
0322|095|I|all your doctors know you use this drug.||
0322|096|B|||
0322|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0322|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0322|099|O|poison control center right away. US residents can call||
0322|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0322|101|B|||
0322|102|N|NOTES:  Do not share this medication with others.||
0322|103|N|   It is important to remove the source of lead exposure. Consult||
0322|104|N|your doctor or pharmacist for details on identifying and avoiding||
0322|105|N|sources of lead exposure.||
0322|106|N|   Lab and/or medical tests (such as complete blood count, blood||
0322|107|N|lead levels, liver function, kidney function) should be done||
0322|108|N|before you start taking this medication and while you are taking||
0322|109|N|it. Keep all medical and lab appointments. Consult your doctor||
0322|110|N|for more details.||
0322|111|B|||
0322|112|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0322|113|D|remember. If it is near the time of the next dose, skip the||
0322|114|D|missed dose. Take your next dose at the regular time. Do not||
0322|115|D|double the dose to catch up.||
0322|116|B|||
0322|117|R|STORAGE:  Store at room temperature away from heat, light, and||
0322|118|R|moisture. Do not store in the bathroom. Keep all medications away||
0322|119|R|from children and pets.||
0322|120|R|   Do not flush medications down the toilet or pour them into a||
0322|121|R|drain unless instructed to do so. Properly discard this product||
0322|122|R|when it is expired or no longer needed. Consult your pharmacist||
0322|123|R|or local waste disposal company.||
0322|124|B|||
0322|125|A|Information last revised April 2025.||
0322|126|A|Copyright(c) 2025 First Databank, Inc.||
0322|127|B|||
0323|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0323|002|Z|does NOT have all possible information about this product. This||
0323|003|Z|information does not assure that this product is safe, effective,||
0323|004|Z|or appropriate for you. This information is not individual||
0323|005|Z|medical advice and does not substitute for the advice of your||
0323|006|Z|health care professional. Always ask your health care||
0323|007|Z|professional for complete information about this product and your||
0323|008|Z|specific health needs.||
0323|009|B|||
0323|010|T|METHAMPHETAMINE - ORAL||
0323|011|F|(meth-am-FET-a-meen HYE-droe-KLOR-ide)||
0323|012|B|||
0323|013|C|COMMON BRAND NAME(S): Desoxyn||
0323|014|B|||
0323|015|W|WARNING:  Misuse or abuse of amphetamines may result in serious||
0323|016|W|(possibly fatal) heart and blood pressure problems.||
0323|017|W|Amphetamine-type medications can be habit-forming. Use only as||
0323|018|W|directed. If you use this drug for a long time, you may become||
0323|019|W|dependent on it and may have withdrawal symptoms after stopping||
0323|020|W|the drug. Consult your doctor or pharmacist for more details.||
0323|021|B|||
0323|022|U|USES:  This medication is used to treat attention deficit||
0323|023|U|hyperactivity disorder - ADHD. It works by changing the amounts||
0323|024|U|of certain natural substances in the brain. Methamphetamine||
0323|025|U|belongs to a class of drugs known as stimulants. It can help||
0323|026|U|increase your ability to pay attention, stay focused on an||
0323|027|U|activity, and control behavior problems. It may also help you to||
0323|028|U|organize your tasks and improve listening skills.||
0323|029|U|   This medication should not be used to treat tiredness or to||
0323|030|U|hold off sleep in people who do not have a sleep disorder.||
0323|031|B|||
0323|032|H|HOW TO USE:  Read the Medication Guide provided by your||
0323|033|H|pharmacist before you start using methamphetamine and each time||
0323|034|H|you get a refill. If you have any questions, ask your doctor or||
0323|035|H|pharmacist.||
0323|036|H|   Take this medication by mouth with or without food as directed||
0323|037|H|by your doctor, usually once or twice daily. During treatment,||
0323|038|H|your doctor may occasionally recommend stopping the medication||
0323|039|H|for a short time to see if there are any changes in your behavior||
0323|040|H|and whether the medication is still needed.||
0323|041|H|   Do not take this medication late in the day because it may||
0323|042|H|cause you to have trouble sleeping.||
0323|043|H|   If you suddenly stop using this medication, you may have||
0323|044|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
0323|045|H|mental/mood changes such as depression). To help prevent||
0323|046|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0323|047|H|more likely if you have used methamphetamine for a long time or||
0323|048|H|in high doses. Tell your doctor or pharmacist right away if you||
0323|049|H|have withdrawal.||
0323|050|H|   When this medication is used for a long time, it may not work||
0323|051|H|as well. Talk with your doctor if this medication stops working||
0323|052|H|well.||
0323|053|H|   Though it helps many people, this medication may sometimes||
0323|054|H|cause addiction. This risk may be higher if you have a substance||
0323|055|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0323|056|H|Take this medication exactly as prescribed to lower the risk of||
0323|057|H|addiction. Ask your doctor or pharmacist for more details.||
0323|058|H|   Tell your doctor if you do not get better or if you get worse.||
0323|059|B|||
0323|060|S|SIDE EFFECTS:  Dry mouth, nausea, upset stomach, diarrhea,||
0323|061|S|constipation, dizziness, weight loss, trouble sleeping, or||
0323|062|S|headache may occur. If any of these effects last or get worse,||
0323|063|S|notify your doctor promptly.||
0323|064|S|   Remember that this medication has been prescribed because your||
0323|065|S|doctor has judged that the benefit to you is greater than the||
0323|066|S|risk of side effects. Many people using this medication do not||
0323|067|S|have serious side effects.||
0323|068|S|   This medication may raise your blood pressure. Check your||
0323|069|S|blood pressure regularly and tell your doctor if the results are||
0323|070|S|high.||
0323|071|S|   Tell your doctor right away if you have any serious side||
0323|072|S|effects, including: signs of blood flow problems in the fingers||
0323|073|S|or toes (such as coldness, numbness, pain, or skin color||
0323|074|S|changes), unusual wounds on the fingers or toes,||
0323|075|S|mental/mood/behavior changes (such as agitation, aggression, mood||
0323|076|S|swings, depression, thoughts of suicide, hallucinations, abnormal||
0323|077|S|thoughts/behavior), uncontrolled muscle movements (such as||
0323|078|S|twitching, shaking), outbursts of words/sounds, swelling||
0323|079|S|ankles/feet, extreme tiredness, rapid/unexplained weight loss,||
0323|080|S|change in sexual ability/interest, frequent/prolonged erections||
0323|081|S|(in males), vision changes (such as blurred vision).||
0323|082|S|   Get medical help right away if you have any very serious side||
0323|083|S|effects, including: fainting, severe headache, fast/pounding||
0323|084|S|irregular heartbeat, seizures, symptoms of a heart attack (such||
0323|085|S|as chest/jaw/left arm pain, shortness of breath, unusual||
0323|086|S|sweating), symptoms of a stroke (such as weakness on one side of||
0323|087|S|the body, trouble speaking, sudden vision changes, confusion).||
0323|088|S|   This medication may increase serotonin and rarely cause a very||
0323|089|S|serious condition called serotonin syndrome/toxicity. The risk||
0323|090|S|increases if you are also taking other drugs that increase||
0323|091|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0323|092|S|take (see Drug Interactions section). Get medical help right away||
0323|093|S|if you develop some of the following symptoms: fast heartbeat,||
0323|094|S|hallucinations, loss of coordination, severe dizziness, severe||
0323|095|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0323|096|S|unusual agitation/restlessness.||
0323|097|S|   A very serious allergic reaction to this drug is rare.||
0323|098|S|However, get medical help right away if you notice any symptoms||
0323|099|S|of a serious allergic reaction, including: rash, itching/swelling||
0323|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0323|101|S|breathing.||
0323|102|S|   This is not a complete list of possible side effects. If you||
0323|103|S|notice other effects not listed above, contact your doctor or||
0323|104|S|pharmacist.||
0323|105|S|   In the US -||
0323|106|S|   Call your doctor for medical advice about side effects. You||
0323|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0323|108|S|www.fda.gov/medwatch.||
0323|109|S|   In Canada - Call your doctor for medical advice about side||
0323|110|S|effects. You may report side effects to Health Canada at||
0323|111|S|1-866-234-2345.||
0323|112|B|||
0323|113|P|PRECAUTIONS:  Before taking methamphetamine, tell your doctor or||
0323|114|P|pharmacist if you are allergic to it; or to other sympathomimetic||
0323|115|P|amines (such as dextroamphetamine); or if you have any other||
0323|116|P|allergies. This product may contain inactive ingredients, which||
0323|117|P|can cause allergic reactions or other problems. Talk to your||
0323|118|P|pharmacist for more details.||
0323|119|P|   Before using this medication, tell your doctor or pharmacist||
0323|120|P|your medical history, especially of: blood circulation problems||
0323|121|P|(such as Raynaud's disease), high blood pressure, diabetes,||
0323|122|P|glaucoma, heart problems (including irregular heartbeat/rhythm,||
0323|123|P|coronary artery disease, heart failure, cardiomyopathy, problems||
0323|124|P|with the heart structure such as valve problems), mental/mood||
0323|125|P|conditions (especially anxiety, tension, agitation),||
0323|126|P|personal/family history of mental/mood disorders (such as bipolar||
0323|127|P|disorder, depression, psychotic disorder, suicidal thoughts),||
0323|128|P|personal or family history of a substance use disorder (such as||
0323|129|P|overuse of or addiction to drugs/alcohol), personal or family||
0323|130|P|history of uncontrolled muscle movements (such as motor tics,||
0323|131|P|Tourette's syndrome), seizures, stroke, overactive thyroid||
0323|132|P|(hyperthyroidism).||
0323|133|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0323|134|P|can make you more dizzy. Do not drive, use machinery, or do||
0323|135|P|anything that needs alertness until you can do it safely. Limit||
0323|136|P|alcoholic beverages. Talk to your doctor if you are using||
0323|137|P|marijuana (cannabis).||
0323|138|P|   If you have diabetes, check your blood sugar regularly as||
0323|139|P|directed and share the results with your doctor. Your doctor may||
0323|140|P|need to adjust your diabetes medication during treatment with||
0323|141|P|this drug.||
0323|142|P|   Before having surgery, tell your doctor or dentist about all||
0323|143|P|the products you use (including prescription drugs,||
0323|144|P|nonprescription drugs, and herbal products).||
0323|145|P|   Older adults may be more sensitive to the side effects of this||
0323|146|P|drug, especially chest pain, trouble sleeping, or weight loss.||
0323|147|P|   Children may be more sensitive to the side effects of this||
0323|148|P|drug, especially weight loss. This medication may slow down a||
0323|149|P|child's growth. The doctor may recommend temporarily stopping the||
0323|150|P|medication from time to time to reduce this risk. Monitor your||
0323|151|P|child's weight and height. Consult your doctor or pharmacist for||
0323|152|P|more details.||
0323|153|P|   During pregnancy, this medication should be used only when||
0323|154|P|clearly needed. Infants born to mothers who are dependent on this||
0323|155|P|medication may be born too soon (premature) and have low birth||
0323|156|P|weight. Discuss the risks and benefits with your doctor. They may||
0323|157|P|also have withdrawal symptoms such as abnormal/nonstop crying,||
0323|158|P|irritability, or unusual tiredness. Tell your doctor right away||
0323|159|P|if you notice any of these symptoms in your newborn.||
0323|160|P|   This drug passes into breast milk and may have undesirable||
0323|161|P|effects on a nursing infant. Breastfeeding is not recommended||
0323|162|P|while using this drug. Consult your doctor before breastfeeding.||
0323|163|B|||
0323|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0323|165|I|medications work or increase your risk for serious side effects.||
0323|166|I|This document does not contain all possible drug interactions.||
0323|167|I|Keep a list of all the products you use (including||
0323|168|I|prescription/nonprescription drugs and herbal products) and share||
0323|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
0323|170|I|the dosage of any medicines without your doctor's approval.||
0323|171|I|   Taking MAO inhibitors with this medication may cause a serious||
0323|172|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0323|173|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0323|174|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0323|175|I|selegiline, tranylcypromine) during treatment with this||
0323|176|I|medication. Most MAO inhibitors should also not be taken for two||
0323|177|I|weeks before treatment with this medication. Ask your doctor when||
0323|178|I|to start or stop taking this medication.||
0323|179|I|   Some products have ingredients that could raise your heart||
0323|180|I|rate or blood pressure. Tell your pharmacist what products you||
0323|181|I|are using, and ask how to use them safely (especially||
0323|182|I|cough-and-cold products, diet aids, or NSAIDs such as||
0323|183|I|ibuprofen/naproxen).||
0323|184|I|   The risk of serotonin syndrome/toxicity increases if you are||
0323|185|I|also taking other drugs that increase serotonin. Examples include||
0323|186|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
0323|187|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0323|188|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0323|189|I|serotonin syndrome/toxicity may be more likely when you start or||
0323|190|I|increase the dose of these drugs.||
0323|191|I|   This medication may interfere with certain medical/lab tests||
0323|192|I|(including brain scan for Parkinson's disease, corticosteroid||
0323|193|I|levels), possibly causing false test results. Make sure lab||
0323|194|I|personnel and all your doctors know you use this drug.||
0323|195|B|||
0323|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0323|197|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0323|198|O|poison control center right away. US residents can call||
0323|199|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0323|200|O|Symptoms of overdose may include: restlessness, shaking (tremor),||
0323|201|O|fast breathing, mental/mood changes, irregular heartbeat, muscle||
0323|202|O|pain/tenderness, weakness, nausea, vomiting, change in the amount||
0323|203|O|of urine.||
0323|204|B|||
0323|205|N|NOTES:  Do not share this medication with others. Sharing it is||
0323|206|N|against the law.||
0323|207|N|   Lab and/or medical tests (such as blood pressure, pulse,||
0323|208|N|height and weight in children) should be done while you are||
0323|209|N|taking this medication. Keep all medical and lab appointments.||
0323|210|B|||
0323|211|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0323|212|D|remember. If it is near the time of the next dose, skip the||
0323|213|D|missed dose. Take your next dose at the regular time. Do not||
0323|214|D|double the dose to catch up.||
0323|215|B|||
0323|216|R|STORAGE:  Store at room temperature away from light and moisture.||
0323|217|R|Do not store in the bathroom. Keep all medications away from||
0323|218|R|children and pets.||
0323|219|R|   Do not flush medications down the toilet or pour them into a||
0323|220|R|drain unless instructed to do so. Properly discard this product||
0323|221|R|when it is expired or no longer needed. Consult your pharmacist||
0323|222|R|or local waste disposal company.||
0323|223|B|||
0323|224|A|Information last revised May 2024.||
0323|225|A|Copyright(c) 2025 First Databank, Inc.||
0323|226|B|||
0324|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0324|002|Z|does NOT have all possible information about this product. This||
0324|003|Z|information does not assure that this product is safe, effective,||
0324|004|Z|or appropriate for you. This information is not individual||
0324|005|Z|medical advice and does not substitute for the advice of your||
0324|006|Z|health care professional. Always ask your health care||
0324|007|Z|professional for complete information about this product and your||
0324|008|Z|specific health needs.||
0324|009|B|||
0324|010|T|FEXOFENADINE 24-HOUR TABLET - ORAL||
0324|011|F|(FEX-oh-FEN-a-deen)||
0324|012|B|||
0324|013|C|COMMON BRAND NAME(S): Allegra||
0324|014|B|||
0324|015|U|USES:  Fexofenadine is an antihistamine used to relieve allergy||
0324|016|U|symptoms such as watery eyes, runny nose, itching eyes/nose,||
0324|017|U|sneezing, hives, and itching. It works by blocking a certain||
0324|018|U|natural substance (histamine) that your body makes during an||
0324|019|U|allergic reaction.||
0324|020|B|||
0324|021|H|HOW TO USE:  If you are taking the over-the-counter product to||
0324|022|H|self-treat, read all directions on the product package before||
0324|023|H|taking this medication. If you have any questions, consult your||
0324|024|H|pharmacist. If your doctor has prescribed this medication, take||
0324|025|H|it as directed with or without food, usually once daily.||
0324|026|H|   Take this medication with water. Do not take with fruit juices||
0324|027|H|(such as apple, grapefruit, or orange) since they may decrease||
0324|028|H|the absorption of this drug.||
0324|029|H|   The dosage is based on your age, medical condition, and||
0324|030|H|response to treatment. Do not increase your dose or take this||
0324|031|H|medication more often than directed.||
0324|032|H|   Do not take antacids containing aluminum and magnesium within||
0324|033|H|2 hours of taking this medication. These antacids can decrease||
0324|034|H|the absorption of fexofenadine.||
0324|035|H|   Tell your doctor if your condition does not get better or if||
0324|036|H|it gets worse.||
0324|037|B|||
0324|038|S|SIDE EFFECTS:  Cough, fever, or stomach upset may occur. If any||
0324|039|S|of these effects last or get worse, tell your doctor or||
0324|040|S|pharmacist promptly.||
0324|041|S|   If your doctor has prescribed this medication, remember that||
0324|042|S|your doctor has judged that the benefit to you is greater than||
0324|043|S|the risk of side effects. Many people using this medication do||
0324|044|S|not have serious side effects.||
0324|045|S|   A very serious allergic reaction to this drug is rare.||
0324|046|S|However, get medical help right away if you notice any symptoms||
0324|047|S|of a serious allergic reaction, including: rash, itching/swelling||
0324|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0324|049|S|breathing.||
0324|050|S|   This is not a complete list of possible side effects. If you||
0324|051|S|notice other effects not listed above, contact your doctor or||
0324|052|S|pharmacist.||
0324|053|S|   In the US -||
0324|054|S|   Call your doctor for medical advice about side effects. You||
0324|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0324|056|S|www.fda.gov/medwatch.||
0324|057|S|   In Canada - Call your doctor for medical advice about side||
0324|058|S|effects. You may report side effects to Health Canada at||
0324|059|S|1-866-234-2345.||
0324|060|B|||
0324|061|P|PRECAUTIONS:  Before taking fexofenadine, tell your doctor or||
0324|062|P|pharmacist if you are allergic to it; or if you have any other||
0324|063|P|allergies. This product may contain inactive ingredients, which||
0324|064|P|can cause allergic reactions or other problems. Talk to your||
0324|065|P|pharmacist for more details.||
0324|066|P|   Before using this medication, tell your doctor or pharmacist||
0324|067|P|your medical history, especially of: kidney disease.||
0324|068|P|   Before having surgery, tell your doctor or dentist about all||
0324|069|P|the products you use (including prescription drugs,||
0324|070|P|nonprescription drugs, and herbal products).||
0324|071|P|   During pregnancy, this medication should be used only when||
0324|072|P|clearly needed. Discuss the risks and benefits with your doctor.||
0324|073|P|   This medication passes into breast milk. Consult your doctor||
0324|074|P|before breastfeeding.||
0324|075|B|||
0324|076|I|DRUG INTERACTIONS:  See also How to Use section.||
0324|077|I|   Drug interactions may change how your medications work or||
0324|078|I|increase your risk for serious side effects. This document does||
0324|079|I|not contain all possible drug interactions. Keep a list of all||
0324|080|I|the products you use (including prescription/nonprescription||
0324|081|I|drugs and herbal products) and share it with your doctor and||
0324|082|I|pharmacist. Do not start, stop, or change the dosage of any||
0324|083|I|medicines without your doctor's approval.||
0324|084|I|   This medication may interfere with certain lab tests (such as||
0324|085|I|allergy skin testing), possibly causing false test results. Make||
0324|086|I|sure lab personnel and all your doctors know you use this drug.||
0324|087|B|||
0324|088|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0324|089|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0324|090|O|poison control center right away. US residents can call||
0324|091|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0324|092|B|||
0324|093|N|NOTES:  Keep all medical and lab appointments.||
0324|094|B|||
0324|095|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0324|096|D|remember. If it is near the time of the next dose, skip the||
0324|097|D|missed dose. Take your next dose at the regular time. Do not||
0324|098|D|double the dose to catch up.||
0324|099|B|||
0324|100|R|STORAGE:  Store at room temperature away from light and moisture.||
0324|101|R|Do not store in the bathroom. Different brands of this medication||
0324|102|R|may have different storage needs. Check the product package for||
0324|103|R|instructions on how to store your brand, or ask your pharmacist.||
0324|104|R|Keep all medications away from children and pets.||
0324|105|R|   Do not flush medications down the toilet or pour them into a||
0324|106|R|drain unless instructed to do so. Properly discard this product||
0324|107|R|when it is expired or no longer needed. Consult your pharmacist||
0324|108|R|or local waste disposal company.||
0324|109|B|||
0324|110|A|Information last revised October 2024.||
0324|111|A|Copyright(c) 2025 First Databank, Inc.||
0324|112|B|||
0325|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0325|002|Z|does NOT have all possible information about this product. This||
0325|003|Z|information does not assure that this product is safe, effective,||
0325|004|Z|or appropriate for you. This information is not individual||
0325|005|Z|medical advice and does not substitute for the advice of your||
0325|006|Z|health care professional. Always ask your health care||
0325|007|Z|professional for complete information about this product and your||
0325|008|Z|specific health needs.||
0325|009|B|||
0325|010|T|MIFEPRISTONE - ORAL||
0325|011|F|(MIF-e-PRIS-tone)||
0325|012|B|||
0325|013|C|COMMON BRAND NAME(S): Mifeprex||
0325|014|B|||
0325|015|W|WARNING:  Rarely, serious medical problems can occur when a||
0325|016|W|pregnancy ends, including sometimes fatal infections and||
0325|017|W|bleeding. Read the Medication Guide, read and sign the Patient||
0325|018|W|Agreement, and consult your doctor if you have any questions. To||
0325|019|W|receive mifepristone in the United States, you must understand,||
0325|020|W|agree to, and carefully follow the requirements of the REMS||
0325|021|W|Program for this medication. If you live in Canada or any other||
0325|022|W|country, consult your doctor and pharmacist for your country's||
0325|023|W|regulations.||
0325|024|W|   Your doctor must give you clear instructions about who to call||
0325|025|W|and what to do in case of an emergency (such as severe bleeding,||
0325|026|W|infection). If you go to the emergency room or visit another||
0325|027|W|health care professional, show them the Medication Guide so they||
0325|028|W|know you are trying to end your pregnancy.||
0325|029|W|   Get medical help right away if you experience symptoms such as||
0325|030|W|severe abdominal pain, fainting, fast heartbeat, fever lasting||
0325|031|W|more than 4 hours. You may have a very serious infection even if||
0325|032|W|you do not have a fever. Get medical help right away if you have||
0325|033|W|abdominal pain or feel sick (for example, if you have nausea,||
0325|034|W|vomiting, diarrhea, weakness) more than 24 hours after taking the||
0325|035|W|second drug (misoprostol), even if you do not have a fever. Also||
0325|036|W|get medical help right away if you have continued heavy bleeding,||
0325|037|W|which may be a sign the pregnancy has not ended or other serious||
0325|038|W|medical problem. You may need surgery or other medical care. See||
0325|039|W|also Side Effects section.||
0325|040|B|||
0325|041|U|USES:  Mifepristone (also known as RU 486) is used to end a||
0325|042|U|pregnancy during the early part of a pregnancy. It is used up to||
0325|043|U|week 10 of pregnancy (up to 70 days after the first day of your||
0325|044|U|last menstrual period). Mifepristone blocks a natural substance||
0325|045|U|(progesterone) that is needed for your pregnancy to continue. It||
0325|046|U|is usually used together with another medicine called||
0325|047|U|misoprostol.||
0325|048|U|   Mifepristone must not be used if you have a rare abnormal||
0325|049|U|pregnancy that is outside the womb (ectopic pregnancy). It will||
0325|050|U|not end the pregnancy in this case. It may cause an ectopic||
0325|051|U|pregnancy to rupture, resulting in very serious bleeding.||
0325|052|B|||
0325|053|H|HOW TO USE:  Read the Medication Guide provided by your doctor||
0325|054|H|before you start using mifepristone. Keep the guide to reread if||
0325|055|H|needed. Read and sign the Patient Agreement form provided by your||
0325|056|H|doctor. If you have any questions, consult your doctor or||
0325|057|H|pharmacist.||
0325|058|H|   You must visit the doctor's office at least 2 times to||
0325|059|H|complete your treatment and important examinations. This||
0325|060|H|treatment is only given under direct medical supervision. Learn||
0325|061|H|about who to call and what to do in case of an emergency.||
0325|062|H|   Your doctor may order an ultrasound to make sure your||
0325|063|H|pregnancy is less than 10 weeks and is not outside the womb||
0325|064|H|(ectopic).||
0325|065|H|   Take mifepristone by mouth as directed by your doctor, usually||
0325|066|H|as a single dose. After taking mifepristone, your doctor should||
0325|067|H|direct you to wait 24 to 48 hours before taking another||
0325|068|H|medication (misoprostol) by mouth as a single dose. The||
0325|069|H|medications may not work well if you take misoprostol sooner than||
0325|070|H|24 hours after taking mifepristone or later than 48 hours after||
0325|071|H|taking mifepristone. Follow your doctor's instructions carefully.||
0325|072|H|Heavy vaginal bleeding does not mean that the pregnancy has||
0325|073|H|ended.||
0325|074|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0325|075|H|using this medication unless your doctor or pharmacist says you||
0325|076|H|may do so safely. Grapefruit can increase the chance of side||
0325|077|H|effects with this medicine. Ask your doctor or pharmacist for||
0325|078|H|more details.||
0325|079|H|   It is important that you return for a follow-up visit within 7||
0325|080|H|to 14 days after taking mifepristone, even if you are not having||
0325|081|H|any problems.||
0325|082|H|   If the pregnancy has not ended, or there are serious medical||
0325|083|H|problems, surgery may be needed. If the treatment fails and the||
0325|084|H|pregnancy continues until birth, there is a risk of birth||
0325|085|H|defects.||
0325|086|B|||
0325|087|S|SIDE EFFECTS:  See also Warning section.||
0325|088|S|   Nausea, vomiting, diarrhea, weakness, or dizziness may occur.||
0325|089|S|If these effects last longer than the first 24 hours after taking||
0325|090|S|the second drug (misoprostol), get medical help right away||
0325|091|S|because they can be signs of a serious medical problem.||
0325|092|S|   Bleeding and cramping are expected during this treatment.||
0325|093|S|Usually, the symptoms mean the drugs are working. However,||
0325|094|S|sometimes you can have cramps and bleeding and still be pregnant.||
0325|095|S|You must return for all of your follow-up visits with your||
0325|096|S|doctor. Nausea and cramping may get worse in the 24 hours after||
0325|097|S|you take the second drug (misoprostol). Your doctor may direct||
0325|098|S|you to take other medication to help with these symptoms. If any||
0325|099|S|of these effects last or get worse, tell your doctor or||
0325|100|S|pharmacist promptly.||
0325|101|S|   Bleeding and spotting may last up to 30 days and may be much||
0325|102|S|heavier than a normal period. In very few cases, this bleeding||
0325|103|S|will need to be stopped by surgery. Get medical help right away||
0325|104|S|if you bleed enough to soak through 2 thick, full-size sanitary||
0325|105|S|pads each hour for 2 hours in a row, or if you are concerned||
0325|106|S|about heavy bleeding.||
0325|107|S|   Remember that this medication has been prescribed because your||
0325|108|S|doctor has judged that the benefit to you is greater than the||
0325|109|S|risk of side effects. Many people using this medication do not||
0325|110|S|have serious side effects.||
0325|111|S|   Get medical help right away if you have any very serious side||
0325|112|S|effects, including: fever of 100.4 degrees F (38 degrees C) or||
0325|113|S|higher, fainting, fast heartbeat, stomach/abdominal pain or||
0325|114|S|tenderness.||
0325|115|S|   A very serious allergic reaction to this drug is rare.||
0325|116|S|However, get medical help right away if you notice any symptoms||
0325|117|S|of a serious allergic reaction, including: rash, itching/swelling||
0325|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0325|119|S|breathing.||
0325|120|S|   This is not a complete list of possible side effects. If you||
0325|121|S|notice other effects not listed above, contact your doctor or||
0325|122|S|pharmacist.||
0325|123|S|   In the US -||
0325|124|S|   Call your doctor for medical advice about side effects. You||
0325|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0325|126|S|www.fda.gov/medwatch.||
0325|127|S|   In Canada - Call your doctor for medical advice about side||
0325|128|S|effects. You may report side effects to Health Canada at||
0325|129|S|1-866-234-2345.||
0325|130|B|||
0325|131|P|PRECAUTIONS:  Before taking mifepristone, tell your doctor if you||
0325|132|P|are allergic to it; or to misoprostol; or to other progestins||
0325|133|P|(such as norethindrone); or if you have any other allergies. This||
0325|134|P|product may contain inactive ingredients, which can cause||
0325|135|P|allergic reactions or other problems. Talk to your pharmacist for||
0325|136|P|more details.||
0325|137|P|   Before using this medication, tell your doctor or pharmacist||
0325|138|P|your medical history, especially of: undiagnosed abdominal growth||
0325|139|P|(adnexal mass), adrenal gland problem, certain blood disorder||
0325|140|P|(inherited porphyrias), bleeding problems, low blood count||
0325|141|P|(anemia).||
0325|142|P|   If you are using an IUD (intrauterine birth control device),||
0325|143|P|it should be removed before mifepristone treatment begins.||
0325|144|P|   This drug must be used only if you can easily reach adequate||
0325|145|P|emergency medical services in case you have a serious medical||
0325|146|P|problem.||
0325|147|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0325|148|P|can make you more dizzy. Do not drive, use machinery, or do||
0325|149|P|anything that needs alertness until you can do it safely. Limit||
0325|150|P|alcoholic beverages. Talk to your doctor if you are using||
0325|151|P|marijuana (cannabis).||
0325|152|P|   Mifepristone usually causes fetal death. In the unlikely event||
0325|153|P|you have an ongoing pregnancy after treatment, birth defects may||
0325|154|P|result.||
0325|155|P|   Another pregnancy can occur after treatment with this||
0325|156|P|medication and before your normal period begins again. Birth||
0325|157|P|control can be started as soon as this treatment is successfully||
0325|158|P|completed. Consult your doctor for more information.||
0325|159|P|   This medication passes into breast milk. Since the effects of||
0325|160|P|mifepristone on infants are unknown, breastfeeding women should||
0325|161|P|consult their doctors on whether they should discard their breast||
0325|162|P|milk for a few days following this treatment.||
0325|163|B|||
0325|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0325|165|I|medications work or increase your risk for serious side effects.||
0325|166|I|This document does not contain all possible drug interactions.||
0325|167|I|Keep a list of all the products you use (including||
0325|168|I|prescription/nonprescription drugs and herbal products) and share||
0325|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
0325|170|I|the dosage of any medicines without your doctor's approval.||
0325|171|I|   Some products that may interact with this drug include:||
0325|172|I|long-term corticosteroid therapy (such as prednisone), other||
0325|173|I|drugs that can cause bleeding/bruising (including antiplatelet||
0325|174|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
0325|175|I|"blood thinners" such as warfarin/dabigatran).||
0325|176|I|   Aspirin can increase the risk of bleeding when used with this||
0325|177|I|medication. However, if your doctor has told you to take low-dose||
0325|178|I|aspirin to prevent heart attack or stroke (usually 81-162||
0325|179|I|milligrams a day), you should keep taking the aspirin unless your||
0325|180|I|doctor tells you not to. Ask your doctor or pharmacist for more||
0325|181|I|details.||
0325|182|I|   Other medications can affect the removal of mifepristone from||
0325|183|I|your body, which may affect how mifepristone works. Examples||
0325|184|I|include azole antifungals (such as itraconazole), dexamethasone,||
0325|185|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
0325|186|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
0325|187|I|as carbamazepine, phenytoin), among others.||
0325|188|I|   Mifepristone can slow down the removal of other medications||
0325|189|I|from your body, which may affect how they work. Examples of||
0325|190|I|affected drugs include cyclosporine, ergot alkaloids (such as||
0325|191|I|dihydroergotamine, ergotamine), fentanyl, pimozide, quinidine,||
0325|192|I|some statin drugs (such as fluvastatin, lovastatin, simvastatin),||
0325|193|I|sirolimus, tacrolimus, warfarin, among others.||
0325|194|B|||
0325|195|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0325|196|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0325|197|O|poison control center right away. US residents can call||
0325|198|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0325|199|O|Symptoms of overdose may include: severe vaginal bleeding.||
0325|200|B|||
0325|201|N|NOTES:  Lab and/or medical tests (such as ultrasound) may be done||
0325|202|N|while you are taking this medication. Keep all medical and lab||
0325|203|N|appointments. Consult your doctor for more details.||
0325|204|B|||
0325|205|D|MISSED DOSE:  You must follow the dosing and appointment schedule||
0325|206|D|as directed by your doctor. If you miss an appointment, contact||
0325|207|D|your doctor right away.||
0325|208|B|||
0325|209|R|STORAGE:  This drug is available only from your doctor. Store at||
0325|210|R|room temperature away from light and moisture. Do not store in||
0325|211|R|the bathroom. Keep all medications away from children and pets.||
0325|212|R|   Do not flush medications down the toilet or pour them into a||
0325|213|R|drain unless instructed to do so. Properly discard this product||
0325|214|R|when it is expired or no longer needed. Consult your pharmacist||
0325|215|R|or local waste disposal company.||
0325|216|B|||
0325|217|A|Information last revised May 2024.||
0325|218|A|Copyright(c) 2025 First Databank, Inc.||
0325|219|B|||
0327|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0327|002|Z|does NOT have all possible information about this product. This||
0327|003|Z|information does not assure that this product is safe, effective,||
0327|004|Z|or appropriate for you. This information is not individual||
0327|005|Z|medical advice and does not substitute for the advice of your||
0327|006|Z|health care professional. Always ask your health care||
0327|007|Z|professional for complete information about this product and your||
0327|008|Z|specific health needs.||
0327|009|B|||
0327|010|T|TEMOZOLOMIDE - ORAL||
0327|011|F|(TEM-oh-ZOL-oh-mide)||
0327|012|B|||
0327|013|C|COMMON BRAND NAME(S): Temodar||
0327|014|B|||
0327|015|U|USES:  This medication is used to treat certain types of brain||
0327|016|U|cancer. Temozolomide belongs to a class of drugs known as||
0327|017|U|alkylating agents. It works by slowing or stopping the growth of||
0327|018|U|cancer cells.||
0327|019|B|||
0327|020|V|OTHER USES:  This section contains uses of this drug that are not||
0327|021|V|listed in the approved professional labeling for the drug but||
0327|022|V|that may be prescribed by your health care professional. Use this||
0327|023|V|drug for a condition that is listed in this section only if it||
0327|024|V|has been so prescribed by your health care professional.||
0327|025|V|   This drug may also be used for other types of cancer (such as||
0327|026|V|bone cancer).||
0327|027|B|||
0327|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0327|029|H|from your pharmacist before you start taking temozolomide and||
0327|030|H|each time you get a refill. If you have any questions, ask your||
0327|031|H|doctor or pharmacist.||
0327|032|H|   Take this medication by mouth as directed by your doctor,||
0327|033|H|usually once a day on a treatment schedule. Swallow the capsules||
0327|034|H|whole with a full glass of water (8 ounces or 240 milliliters).||
0327|035|H|Do not open, chew, or dissolve the contents of the capsules. If||
0327|036|H|you vomit after taking your dose, do not take any more||
0327|037|H|medication. Wait and take your next dose at the regular time. To||
0327|038|H|reduce nausea and vomiting, take temozolomide on an empty stomach||
0327|039|H|or at bedtime. For the best effect, take this medication at the||
0327|040|H|same time every day in relation to a meal (for example, 1 hour||
0327|041|H|before or 3 hours after a meal).||
0327|042|H|   The dosage and treatment schedule are based on your medical||
0327|043|H|condition, height, weight, and response to treatment. Carefully||
0327|044|H|follow your doctor's directions for taking this medication. To||
0327|045|H|help you remember, mark your calendar with a reminder.||
0327|046|H|   Your doctor may also prescribe other medications (such as||
0327|047|H|antibiotics) to help prevent infection or side effects. Follow||
0327|048|H|your doctor's directions for taking all your medications.||
0327|049|H|   Do not increase your dose or use this drug more often or for||
0327|050|H|longer than prescribed. Your condition will not improve any||
0327|051|H|faster, and your risk of serious side effects will increase.||
0327|052|H|   If the capsules are accidentally opened or damaged, avoid||
0327|053|H|inhaling the medication or getting it on your skin. If contact||
0327|054|H|occurs, flush the area with water. Since this drug can be||
0327|055|H|absorbed through the skin and lungs and may harm an unborn baby,||
0327|056|H|women who are pregnant or who may become pregnant should not||
0327|057|H|handle this medication or breathe the dust from the capsules.||
0327|058|B|||
0327|059|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, mouth sores,||
0327|060|S|changes in taste, constipation, tiredness, dizziness, trouble||
0327|061|S|sleeping, or headache may occur. Nausea and vomiting can be||
0327|062|S|severe. In some cases, your doctor may prescribe medication to||
0327|063|S|prevent or relieve nausea and vomiting. Eating several small||
0327|064|S|meals, not eating before treatment, or limiting activity may help||
0327|065|S|lessen some of these effects. If any of these effects last or get||
0327|066|S|worse, tell your doctor or pharmacist promptly.||
0327|067|S|   Temporary hair loss may occur. Normal hair growth should||
0327|068|S|return after treatment has ended.||
0327|069|S|   People using this medication may have serious side effects.||
0327|070|S|However, you have been prescribed this drug because your doctor||
0327|071|S|has judged that the benefit to you is greater than the risk of||
0327|072|S|side effects. Careful monitoring by your doctor may decrease your||
0327|073|S|risk.||
0327|074|S|   Although temozolomide is used to treat cancer, it may rarely||
0327|075|S|increase your risk of getting other cancers. Also, temozolomide||
0327|076|S|decreases bone marrow function, an effect that may lead to a low||
0327|077|S|number of blood cells such as red cells, white cells, and||
0327|078|S|platelets. This effect can cause anemia, decrease your body's||
0327|079|S|ability to fight an infection, or cause easy bruising/bleeding.||
0327|080|S|Tell your doctor right away if you develop any of the following||
0327|081|S|symptoms: unusual tiredness, pale skin, signs of infection (such||
0327|082|S|as sore throat that doesn't go away, fever, chills), easy||
0327|083|S|bruising/bleeding.||
0327|084|S|   Tell your doctor right away if you have any serious side||
0327|085|S|effects, such as: symptoms of liver damage (such as||
0327|086|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0327|087|S|   Get medical help right away if you have any very serious side||
0327|088|S|effects, such as: seizure.||
0327|089|S|   A very serious allergic reaction to this drug is rare.||
0327|090|S|However, get medical help right away if you notice any symptoms||
0327|091|S|of a serious allergic reaction, such as: rash, itching/swelling||
0327|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0327|093|S|breathing.||
0327|094|S|   This is not a complete list of possible side effects. If you||
0327|095|S|notice other effects not listed above, contact your doctor or||
0327|096|S|pharmacist.||
0327|097|S|   In the US -||
0327|098|S|   Call your doctor for medical advice about side effects. You||
0327|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0327|100|S|www.fda.gov/medwatch.||
0327|101|S|   In Canada - Call your doctor for medical advice about side||
0327|102|S|effects. You may report side effects to Health Canada at||
0327|103|S|1-866-234-2345.||
0327|104|B|||
0327|105|P|PRECAUTIONS:  Before taking temozolomide, tell your doctor or||
0327|106|P|pharmacist if you are allergic to it; or to dacarbazine; or if||
0327|107|P|you have any other allergies. This product may contain inactive||
0327|108|P|ingredients, which can cause allergic reactions or other||
0327|109|P|problems. Talk to your pharmacist for more details.||
0327|110|P|   Before using this medication, tell your doctor or pharmacist||
0327|111|P|your medical history, especially of: kidney problems, liver||
0327|112|P|problems, bleeding/blood problems.||
0327|113|P|   Temozolomide can make you more likely to get infections or may||
0327|114|P|make current infections worse. Stay away from anyone who has an||
0327|115|P|infection that may easily spread (such as chickenpox, COVID-19,||
0327|116|P|measles, flu). Talk to your doctor if you have been exposed to an||
0327|117|P|infection or for more details.||
0327|118|P|   Tell your health care professional that you are using||
0327|119|P|temozolomide before having any immunizations/vaccinations. Avoid||
0327|120|P|contact with people who have recently received live vaccines||
0327|121|P|(such as flu vaccine inhaled through the nose).||
0327|122|P|   To lower the chance of getting cut, bruised, or injured, use||
0327|123|P|caution with sharp objects like razors and nail cutters, and||
0327|124|P|avoid activities such as contact sports.||
0327|125|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0327|126|P|can make you more dizzy. Do not drive, use machinery, or do||
0327|127|P|anything that needs alertness until you can do it safely. Limit||
0327|128|P|alcoholic beverages. Talk to your doctor if you are using||
0327|129|P|marijuana (cannabis).||
0327|130|P|   Before having surgery, tell your doctor or dentist about all||
0327|131|P|the products you use (such as prescription drugs, nonprescription||
0327|132|P|drugs, and herbal products).||
0327|133|P|   Women and older adults may be more sensitive to the side||
0327|134|P|effects of this drug, especially increased risk of infection and||
0327|135|P|easy bruising/bleeding.||
0327|136|P|   Men should not donate sperm while using temozolomide and for 3||
0327|137|P|months after stopping this drug.||
0327|138|P|   Since this drug can be absorbed through the skin and lungs and||
0327|139|P|may harm an unborn baby, women who are pregnant or who may become||
0327|140|P|pregnant should not handle this medication or breathe the dust||
0327|141|P|from the capsules.||
0327|142|P|   Tell your doctor if you are pregnant or plan to become||
0327|143|P|pregnant. You should not become pregnant while using||
0327|144|P|temozolomide. Temozolomide may harm an unborn baby. Your doctor||
0327|145|P|should order a pregnancy test before you start this medication.||
0327|146|P|Women using this medication should ask about reliable forms of||
0327|147|P|birth control during treatment and for 6 months after the last||
0327|148|P|dose. Men using this medication who have a partner that is||
0327|149|P|pregnant or who can become pregnant should use condoms for birth||
0327|150|P|control during treatment and for some time after the last dose.||
0327|151|P|If you or your partner becomes pregnant, talk to your doctor||
0327|152|P|right away about the risks and benefits of this medication.||
0327|153|P|   It is unknown if this drug passes into breast milk. Because of||
0327|154|P|the possible risk to the infant, breastfeeding is not recommended||
0327|155|P|while using this drug and for 1 week after the last dose. Consult||
0327|156|P|your doctor before breastfeeding.||
0327|157|B|||
0327|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0327|159|I|medications work or increase your risk for serious side effects.||
0327|160|I|This document does not contain all possible drug interactions.||
0327|161|I|Keep a list of all the products you use (such as||
0327|162|I|prescription/nonprescription drugs and herbal products) and share||
0327|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
0327|164|I|the dosage of any medicines without your doctor's approval.||
0327|165|B|||
0327|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0327|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0327|168|O|poison control center right away. US residents can call||
0327|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0327|170|B|||
0327|171|N|NOTES:  Do not share this medication with others.||
0327|172|N|   Lab and/or medical tests (such as complete blood count, liver||
0327|173|N|function, brain scan) should be done before you start taking this||
0327|174|N|medication and while you are taking it. Keep all medical and lab||
0327|175|N|appointments.||
0327|176|B|||
0327|177|D|MISSED DOSE:  It is important to take each dose of this||
0327|178|D|medication as scheduled. If you miss a dose, ask your doctor or||
0327|179|D|pharmacist right away for a new dosing schedule. Do not double||
0327|180|D|the dose to catch up.||
0327|181|B|||
0327|182|R|STORAGE:  Store at room temperature away from light and moisture.||
0327|183|R|Do not store in the bathroom. Keep all medications away from||
0327|184|R|children and pets.||
0327|185|R|   Do not flush medications down the toilet or pour them into a||
0327|186|R|drain unless instructed to do so. Properly discard this product||
0327|187|R|when it is expired or no longer needed. Consult your pharmacist||
0327|188|R|or local waste disposal company.||
0327|189|B|||
0327|190|M|MEDICAL ALERT:  Your condition can cause complications in a||
0327|191|M|medical emergency. For information about enrolling in MedicAlert,||
0327|192|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0327|193|B|||
0327|194|A|Information last revised October 2024.||
0327|195|A|Copyright(c) 2025 First Databank, Inc.||
0327|196|B|||
0328|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0328|002|Z|does NOT have all possible information about this product. This||
0328|003|Z|information does not assure that this product is safe, effective,||
0328|004|Z|or appropriate for you. This information is not individual||
0328|005|Z|medical advice and does not substitute for the advice of your||
0328|006|Z|health care professional. Always ask your health care||
0328|007|Z|professional for complete information about this product and your||
0328|008|Z|specific health needs.||
0328|009|B|||
0328|010|T|SOY (GLYCINE SOYA) - ORAL||
0328|011|B|||
0328|012|U|USES:  Soy has been used to treat certain symptoms of menopause||
0328|013|U|(such as hot flashes) and to help prevent bone loss||
0328|014|U|(osteoporosis).||
0328|015|U|   Some supplement products have been found to contain possibly||
0328|016|U|harmful impurities/additives. Check with your pharmacist for more||
0328|017|U|details about the brand you use.||
0328|018|U|   The FDA has not reviewed this product for safety or||
0328|019|U|effectiveness. Consult your doctor or pharmacist for more||
0328|020|U|details.||
0328|021|B|||
0328|022|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
0328|023|H|directions on the product package, or take as directed by your||
0328|024|H|doctor. If you have any questions, ask your doctor or pharmacist.||
0328|025|H|   If your condition lasts or gets worse, or if you think you may||
0328|026|H|have a serious medical problem, get medical help right away.||
0328|027|B|||
0328|028|S|SIDE EFFECTS:  Stomach upset or nausea may occur. If either of||
0328|029|S|these effects last or get worse, tell your doctor or pharmacist||
0328|030|S|promptly.||
0328|031|S|   A very serious allergic reaction to this product is rare.||
0328|032|S|However, get medical help right away if you notice any symptoms||
0328|033|S|of a serious allergic reaction, including: rash, itching/swelling||
0328|034|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0328|035|S|breathing.||
0328|036|S|   This is not a complete list of possible side effects. If you||
0328|037|S|notice other effects not listed above, contact your doctor or||
0328|038|S|pharmacist.||
0328|039|S|   In the US -||
0328|040|S|   Call your doctor for medical advice about side effects. You||
0328|041|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0328|042|S|www.fda.gov/medwatch.||
0328|043|S|   In Canada - Call your doctor for medical advice about side||
0328|044|S|effects. You may report side effects to Health Canada at||
0328|045|S|1-866-234-2345.||
0328|046|B|||
0328|047|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0328|048|P|pharmacist if you are allergic to it; or if you have any other||
0328|049|P|allergies. This product may contain inactive ingredients, which||
0328|050|P|can cause allergic reactions or other problems. Talk to your||
0328|051|P|pharmacist for more details.||
0328|052|P|   If you have the following health problem, consult your doctor||
0328|053|P|or pharmacist before using this product: underactive thyroid||
0328|054|P|(hypothyroidism).||
0328|055|P|   Before having surgery, tell your doctor or dentist about all||
0328|056|P|the products you use (including prescription drugs,||
0328|057|P|nonprescription drugs, and herbal products).||
0328|058|P|   During pregnancy, this product should be used only when||
0328|059|P|clearly needed. Discuss the risks and benefits with your doctor.||
0328|060|P|   It is unknown if this product passes into breast milk. Consult||
0328|061|P|your doctor before breastfeeding.||
0328|062|B|||
0328|063|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0328|064|I|medications work or increase your risk for serious side effects.||
0328|065|I|This document does not contain all possible drug interactions.||
0328|066|I|Keep a list of all the products you use (including||
0328|067|I|prescription/nonprescription drugs and herbal products) and share||
0328|068|I|it with your doctor and pharmacist. Do not start, stop, or change||
0328|069|I|the dosage of any medicines without your doctor's approval.||
0328|070|B|||
0328|071|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0328|072|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0328|073|O|poison control center right away. US residents can call||
0328|074|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0328|075|B|||
0328|076|N|NOTES:  Keep all medical and lab appointments.||
0328|077|B|||
0328|078|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0328|079|D|remember. If it is near the time of the next dose, skip the||
0328|080|D|missed dose. Take your next dose at the regular time. Do not||
0328|081|D|double the dose to catch up.||
0328|082|B|||
0328|083|R|STORAGE:  Refer to storage information printed on the package. If||
0328|084|R|you have any questions about storage, ask your pharmacist. Keep||
0328|085|R|all medications and herbal products away from children and pets.||
0328|086|R|   Do not flush medications down the toilet or pour them into a||
0328|087|R|drain unless instructed to do so. Properly discard this product||
0328|088|R|when it is expired or no longer needed. Consult your pharmacist||
0328|089|R|or local waste disposal company.||
0328|090|B|||
0328|091|A|Information last revised May 2024.||
0328|092|A|Copyright(c) 2025 First Databank, Inc.||
0328|093|B|||
0330|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0330|002|Z|does NOT have all possible information about this product. This||
0330|003|Z|information does not assure that this product is safe, effective,||
0330|004|Z|or appropriate for you. This information is not individual||
0330|005|Z|medical advice and does not substitute for the advice of your||
0330|006|Z|health care professional. Always ask your health care||
0330|007|Z|professional for complete information about this product and your||
0330|008|Z|specific health needs.||
0330|009|B|||
0330|010|T|ABACAVIR/LAMIVUDINE/ZIDOVUDINE - ORAL||
0330|011|F|(a-BAK-a-vir/la-MIV-ue-deen/zye-DOE-vue-deen)||
0330|012|B|||
0330|013|C|COMMON BRAND NAME(S): Trizivir||
0330|014|B|||
0330|015|W|WARNING:  In some patients, the abacavir in this product has||
0330|016|W|caused a serious (sometimes fatal) allergic reaction. Your doctor||
0330|017|W|should order a blood test to measure your risk before you start||
0330|018|W|this medication or take it again. If the blood test shows you are||
0330|019|W|at greater risk, you should not take this medication and your||
0330|020|W|doctor should discuss other treatment choices with you. Symptoms||
0330|021|W|of an allergic reaction may include any of the following: rash,||
0330|022|W|itching/swelling (especially of the face/tongue/throat), severe||
0330|023|W|dizziness, trouble breathing, fever, extreme tiredness, nausea,||
0330|024|W|vomiting, diarrhea, stomach pain, muscle aches, sore throat,||
0330|025|W|mouth sores, or cough. Get medical help right away if you||
0330|026|W|experience any of these symptoms. If you have stopped taking||
0330|027|W|abacavir because of an allergic reaction, you must never take any||
0330|028|W|form of abacavir again, or death could result. Tell all of your||
0330|029|W|doctors and pharmacists if you have stopped taking abacavir due||
0330|030|W|to an allergic reaction. Also, properly throw away any unused||
0330|031|W|medications containing abacavir. Read the warning card provided||
0330|032|W|with this medication for more details.||
0330|033|W|   The zidovudine in this product can decrease bone marrow||
0330|034|W|function, which may lead to low numbers of red and white blood||
0330|035|W|cells. A low number of red blood cells can lead to anemia. A low||
0330|036|W|number of white blood cells can decrease your body's ability to||
0330|037|W|fight serious, life-threatening infections. These serious side||
0330|038|W|effects occur more often in people with advanced HIV disease||
0330|039|W|(AIDS). Tell your doctor right away if you develop any signs of||
0330|040|W|anemia (such as unusual tiredness, fast breathing, pale skin,||
0330|041|W|fast heartbeat) or signs of infection (such as sore throat that||
0330|042|W|doesn't go away, fever, chills). Your doctor will check your||
0330|043|W|blood cell counts while you are taking this medication to||
0330|044|W|decrease the risk of these side effects.||
0330|045|W|   Zidovudine may also cause muscle problems. Tell your doctor||
0330|046|W|right away if you develop signs of muscle problems (such as||
0330|047|W|wasting or decrease in muscle size, weight loss, muscle||
0330|048|W|weakness/pain/tenderness).||
0330|049|W|   Rarely, abacavir/lamivudine/zidovudine has caused severe||
0330|050|W|(sometimes fatal) liver problems and a certain metabolic problem||
0330|051|W|(lactic acidosis). Get medical help right away if you develop any||
0330|052|W|of the following symptoms: nausea, vomiting, stomach/abdominal||
0330|053|W|pain, unusual tiredness, dark urine, yellowing eyes/skin,||
0330|054|W|deep/rapid breathing, or drowsiness. These serious side effects||
0330|055|W|may occur more often in women and obese patients.||
0330|056|W|   If you have hepatitis B infection and HIV, you may have a||
0330|057|W|serious worsening of hepatitis symptoms if you stop taking||
0330|058|W|lamivudine. Talk with your doctor before stopping this||
0330|059|W|medication. Your doctor will monitor liver tests for several||
0330|060|W|months after you stop lamivudine. Get medical help right away if||
0330|061|W|you develop symptoms of worsening liver problems.||
0330|062|B|||
0330|063|U|USES:  This product contains 3 drugs: abacavir, lamivudine, and||
0330|064|U|zidovudine. It is used alone or with other HIV medications to||
0330|065|U|help control HIV infection. It helps to decrease the amount of||
0330|066|U|HIV in your body so your immune system can work better. This||
0330|067|U|lowers your chance of getting HIV complications (such as new||
0330|068|U|infections, cancer) and improves your quality of life. Abacavir,||
0330|069|U|lamivudine, and zidovudine all belong to a class of drugs known||
0330|070|U|as nucleoside reverse transcriptase inhibitors (NRTIs).||
0330|071|U|   Abacavir/lamivudine/zidovudine is not a cure for HIV||
0330|072|U|infection. To decrease your risk of spreading HIV disease to||
0330|073|U|others, continue to take all HIV medications exactly as||
0330|074|U|prescribed by your doctor. Use an effective barrier method (latex||
0330|075|U|or polyurethane condoms/dental dams) during sexual activity as||
0330|076|U|directed by your doctor. Do not share personal items (such as||
0330|077|U|needles/syringes, toothbrushes, and razors) that may have||
0330|078|U|contacted blood or other body fluids. Consult your doctor or||
0330|079|U|pharmacist for more details.||
0330|080|B|||
0330|081|H|HOW TO USE:  Read the Medication Guide and Warning Card provided||
0330|082|H|by your pharmacist before you start taking||
0330|083|H|abacavir/lamivudine/zidovudine and each time you get a refill.||
0330|084|H|Carry the Warning Card with you at all times. If you have any||
0330|085|H|questions, ask your doctor or pharmacist.||
0330|086|H|   Take this medication by mouth with or without food as directed||
0330|087|H|by your doctor, usually twice daily. Take this medication with a||
0330|088|H|full glass of water (8 ounces/240 milliliters) unless your doctor||
0330|089|H|directs you otherwise.||
0330|090|H|   Because this combination product has fixed doses of abacavir,||
0330|091|H|lamivudine, and zidovudine, it should only be used if your doctor||
0330|092|H|has determined that the doses of all 3 medications in this||
0330|093|H|product are right for you.||
0330|094|H|   If you stop taking any medication containing abacavir even for||
0330|095|H|a short time and then restart the drug, you have an increased||
0330|096|H|chance of developing a very serious (possibly fatal) allergic||
0330|097|H|reaction. Refill your medication before you run out. Do not stop||
0330|098|H|treatment unless directed by your doctor. Before restarting any||
0330|099|H|medication containing abacavir, consult your doctor or||
0330|100|H|pharmacist, and be sure you have easy access to medical care.||
0330|101|H|   It is very important to keep taking this medication (and other||
0330|102|H|HIV medications) exactly as prescribed by your doctor. Do not||
0330|103|H|skip any doses. Do not increase your dose, take this drug more||
0330|104|H|often than prescribed, or stop taking it (or other HIV medicines)||
0330|105|H|even for a short time unless directed to do so by your doctor.||
0330|106|H|Skipping or changing your dose without approval from your doctor||
0330|107|H|may cause the amount of virus to increase, make the infection||
0330|108|H|more difficult to treat (resistant), or worsen side effects.||
0330|109|H|   For the best effect, take this medication at evenly spaced||
0330|110|H|times. To help you remember, take this medication at the same||
0330|111|H|times every day.||
0330|112|B|||
0330|113|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
0330|114|S|   Headache, tiredness, weakness, nausea, vomiting, loss of||
0330|115|S|appetite, diarrhea, dizziness, or trouble sleeping may occur. If||
0330|116|S|any of these effects last or get worse, tell your doctor or||
0330|117|S|pharmacist promptly.||
0330|118|S|   Remember that this medication has been prescribed because your||
0330|119|S|doctor has judged that the benefit to you is greater than the||
0330|120|S|risk of side effects. Many people using this medication do not||
0330|121|S|have serious side effects.||
0330|122|S|   As your immune system gets stronger, it can begin to fight off||
0330|123|S|infections you already had, possibly causing disease symptoms to||
0330|124|S|come back. You could also have symptoms if your immune system||
0330|125|S|becomes overactive. This reaction may happen at any time (soon||
0330|126|S|after starting HIV treatment or many months later). Tell your||
0330|127|S|doctor right away if you have any serious symptoms, including:||
0330|128|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
0330|129|S|that doesn't go away, headaches that are severe or don't go away,||
0330|130|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
0330|131|S|changes, signs of infection (such as sore throat that doesn't go||
0330|132|S|away, fever, chills, swollen lymph nodes, non-healing skin||
0330|133|S|sores), signs of an overactive thyroid (such as irritability,||
0330|134|S|nervousness, heat intolerance, fast/pounding/irregular||
0330|135|S|heartbeat).||
0330|136|S|   Tell your doctor right away if you have any serious side||
0330|137|S|effects, including: mental/mood changes (such as depression,||
0330|138|S|anxiety), easy bruising/bleeding, skin/nail color changes.||
0330|139|S|   Get medical help right away if you have any very serious side||
0330|140|S|effects, including: signs of pancreatitis (such as nausea,||
0330|141|S|vomiting, stomach/abdominal/back pain, fever).||
0330|142|S|   Loss of body fat (such as in the face, arms, legs, and||
0330|143|S|buttocks) may occur while you are taking this medication. This||
0330|144|S|effect may be permanent. Tell your doctor right away if you||
0330|145|S|notice any changes in body fat.||
0330|146|S|   This is not a complete list of possible side effects. If you||
0330|147|S|notice other effects not listed above, contact your doctor or||
0330|148|S|pharmacist.||
0330|149|S|   In the US -||
0330|150|S|   Call your doctor for medical advice about side effects. You||
0330|151|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0330|152|S|www.fda.gov/medwatch.||
0330|153|S|   In Canada - Call your doctor for medical advice about side||
0330|154|S|effects. You may report side effects to Health Canada at||
0330|155|S|1-866-234-2345.||
0330|156|B|||
0330|157|P|PRECAUTIONS:  Before taking abacavir/lamivudine/zidovudine, tell||
0330|158|P|your doctor or pharmacist if you are allergic to any of these||
0330|159|P|drugs; or if you have any other allergies. This product may||
0330|160|P|contain inactive ingredients, which can cause allergic reactions||
0330|161|P|or other problems. Talk to your pharmacist for more details.||
0330|162|P|   Before using this medication, tell your doctor or pharmacist||
0330|163|P|your medical history, especially of: kidney problems, liver||
0330|164|P|problems (such as hepatitis B or C, cirrhosis), disease of the||
0330|165|P|pancreas (pancreatitis), alcohol use, low red/white blood cell||
0330|166|P|counts.||
0330|167|P|   Abacavir may increase your risk of a heart attack. Discuss the||
0330|168|P|risks and benefits of treatment with your doctor and ways to||
0330|169|P|lower your risk of heart disease. Tell your doctor if you have||
0330|170|P|heart problems, if you smoke, or if you have other conditions||
0330|171|P|that increase your risk of heart disease, such as high blood||
0330|172|P|pressure, diabetes, or high cholesterol levels.||
0330|173|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0330|174|P|can make you more dizzy. Do not drive, use machinery, or do||
0330|175|P|anything that needs alertness until you can do it safely. Limit||
0330|176|P|alcoholic beverages. Alcohol may also increase the risk of liver||
0330|177|P|problems and pancreatitis. Talk to your doctor if you are using||
0330|178|P|marijuana (cannabis).||
0330|179|P|   Before having surgery, tell your doctor or dentist about all||
0330|180|P|the products you use (including prescription drugs,||
0330|181|P|nonprescription drugs, and herbal products).||
0330|182|P|   Children may be more sensitive to the side effects of this||
0330|183|P|drug, especially pancreatitis.||
0330|184|P|   Tell your doctor if you are pregnant before using this||
0330|185|P|medication. Treatment can lower the risk of passing HIV infection||
0330|186|P|to your baby. Discuss the risks and benefits with your doctor.||
0330|187|P|   This medication passes into breast milk. Because breast milk||
0330|188|P|may transmit HIV, consult your doctor before breastfeeding.||
0330|189|B|||
0330|190|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0330|191|I|medications work or increase your risk for serious side effects.||
0330|192|I|This document does not contain all possible drug interactions.||
0330|193|I|Keep a list of all the products you use (including||
0330|194|I|prescription/nonprescription drugs and herbal products) and share||
0330|195|I|it with your doctor and pharmacist. Do not start, stop, or change||
0330|196|I|the dosage of any medicines without your doctor's approval.||
0330|197|I|   Some products that may interact with this drug include:||
0330|198|I|orlistat, ribavirin, sorbitol, stavudine, drugs that may decrease||
0330|199|I|bone marrow function or lower blood cell counts (such as||
0330|200|I|ganciclovir, trimethoprim, cancer chemotherapy including||
0330|201|I|doxorubicin).||
0330|202|I|   Other medications can affect the removal of zidovudine from||
0330|203|I|your body, which may affect how abacavir/lamivudine/zidovudine||
0330|204|I|works. Examples include rifampin, valproic acid, among others.||
0330|205|I|   If you are also taking clarithromycin, take this medication at||
0330|206|I|least 2 hours apart from your clarithromycin dose.||
0330|207|I|   Do not take other products that contain abacavir, lamivudine,||
0330|208|I|or zidovudine with this medication.||
0330|209|I|   Emtricitabine is similar to lamivudine and should not be taken||
0330|210|I|with this medication.||
0330|211|B|||
0330|212|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0330|213|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0330|214|O|poison control center right away. US residents can call||
0330|215|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0330|216|B|||
0330|217|N|NOTES:  Do not share this medication with others.||
0330|218|N|   Lab and/or medical tests (such as blood cell counts,||
0330|219|N|liver/kidney function, viral load, T-cell counts) should be done||
0330|220|N|while you are taking this medication. Keep all medical and lab||
0330|221|N|appointments. Consult your doctor for more details.||
0330|222|B|||
0330|223|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0330|224|D|remember. If it is near the time of the next dose, skip the||
0330|225|D|missed dose. Take your next dose at the regular time. Do not||
0330|226|D|double the dose to catch up.||
0330|227|B|||
0330|228|R|STORAGE:  Store at room temperature away from light and moisture.||
0330|229|R|Do not store in the bathroom. Keep all medications away from||
0330|230|R|children and pets.||
0330|231|R|   Do not flush medications down the toilet or pour them into a||
0330|232|R|drain unless instructed to do so. Properly discard this product||
0330|233|R|when it is expired or no longer needed. Consult your pharmacist||
0330|234|R|or local waste disposal company.||
0330|235|B|||
0330|236|A|Information last revised August 2025.||
0330|237|A|Copyright(c) 2025 First Databank, Inc.||
0330|238|B|||
0331|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0331|002|Z|does NOT have all possible information about this product. This||
0331|003|Z|information does not assure that this product is safe, effective,||
0331|004|Z|or appropriate for you. This information is not individual||
0331|005|Z|medical advice and does not substitute for the advice of your||
0331|006|Z|health care professional. Always ask your health care||
0331|007|Z|professional for complete information about this product and your||
0331|008|Z|specific health needs.||
0331|009|B|||
0331|010|T|SODIUM CHLORIDE SPRAY - NASAL||
0331|011|F|(SOE-dee-um KLOR-ide)||
0331|012|B|||
0331|013|C|COMMON BRAND NAME(S): Ocean||
0331|014|B|||
0331|015|U|USES:  This product is used to treat dryness inside the nose||
0331|016|U|(nasal passages). It helps add moisture inside the nose to||
0331|017|U|dissolve and soften thick or crusty mucus. In babies and young||
0331|018|U|children with stuffy noses who cannot blow their noses, using||
0331|019|U|this product helps to make the mucus easier to remove with a||
0331|020|U|nasal bulb syringe. This helps relieve stuffiness and makes||
0331|021|U|breathing easier.||
0331|022|U|   This product contains a purified gentle salt solution (also||
0331|023|U|called saline or sodium chloride solution). It does not contain||
0331|024|U|any medication.||
0331|025|B|||
0331|026|H|HOW TO USE:  Spray this product into each nostril as needed or as||
0331|027|H|directed by your doctor. This product may also be given into the||
0331|028|H|nose as drops or a stream. Follow all directions on the product||
0331|029|H|package. If you have any questions, ask your doctor or||
0331|030|H|pharmacist.||
0331|031|H|   Try not to touch the container tip to the inside of your nose.||
0331|032|H|If this happens, rinse the tip with hot water and dry with a||
0331|033|H|clean tissue before recapping the container.||
0331|034|H|   If your condition lasts or gets worse, or if you think you may||
0331|035|H|have a serious medical problem, get medical help right away.||
0331|036|B|||
0331|037|S|SIDE EFFECTS:  Side effects usually do not occur with use of this||
0331|038|S|product. However, if the inside of your nose is very dry and||
0331|039|S|irritated, stinging may occur. If this effect lasts or gets||
0331|040|S|worse, tell your doctor or pharmacist promptly.||
0331|041|S|   If your doctor has directed you to use this medication,||
0331|042|S|remember that your doctor has judged that the benefit to you is||
0331|043|S|greater than the risk of side effects. Many people using this||
0331|044|S|medication do not have serious side effects.||
0331|045|S|   A very serious allergic reaction to this drug is rare.||
0331|046|S|However, get medical help right away if you notice any symptoms||
0331|047|S|of a serious allergic reaction, including: rash, itching/swelling||
0331|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0331|049|S|breathing.||
0331|050|S|   This is not a complete list of possible side effects. If you||
0331|051|S|notice other effects not listed above, contact your doctor or||
0331|052|S|pharmacist.||
0331|053|S|   In the US -||
0331|054|S|   Call your doctor for medical advice about side effects. You||
0331|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0331|056|S|www.fda.gov/medwatch.||
0331|057|S|   In Canada - Call your doctor for medical advice about side||
0331|058|S|effects. You may report side effects to Health Canada at||
0331|059|S|1-866-234-2345.||
0331|060|B|||
0331|061|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0331|062|P|pharmacist if you are allergic to it; or if you have any other||
0331|063|P|allergies. This product may contain inactive ingredients, which||
0331|064|P|can cause allergic reactions or other problems. Talk to your||
0331|065|P|pharmacist for more details||
0331|066|P|   Before having surgery, tell your doctor or dentist about all||
0331|067|P|the products you use (including prescription drugs,||
0331|068|P|nonprescription drugs, and herbal products).||
0331|069|P|   This product is safe to use during pregnancy.||
0331|070|P|   This product is safe to use if you are breastfeeding.||
0331|071|B|||
0331|072|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0331|073|I|medications work or increase your risk for serious side effects.||
0331|074|I|This document does not contain all possible drug interactions.||
0331|075|I|Keep a list of all the products you use (including||
0331|076|I|prescription/nonprescription drugs and herbal products) and share||
0331|077|I|it with your doctor and pharmacist. Do not start, stop, or change||
0331|078|I|the dosage of any medicines without your doctor's approval.||
0331|079|B|||
0331|080|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0331|081|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0331|082|O|poison control center right away. US residents can call||
0331|083|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0331|084|B|||
0331|085|N|NOTES:  Do not share this product with others. Doing so may||
0331|086|N|increase the risk of infection.||
0331|087|B|||
0331|088|D|MISSED DOSE:  Not applicable.||
0331|089|B|||
0331|090|R|STORAGE:  Refer to storage information printed on the package. If||
0331|091|R|you have any questions about storage, ask your pharmacist. Keep||
0331|092|R|all medications away from children and pets.||
0331|093|R|   Do not flush medications down the toilet or pour them into a||
0331|094|R|drain unless instructed to do so. Properly discard this product||
0331|095|R|when it is expired or no longer needed. Consult your pharmacist||
0331|096|R|or local waste disposal company.||
0331|097|B|||
0331|098|A|Information last revised May 2024.||
0331|099|A|Copyright(c) 2025 First Databank, Inc.||
0331|100|B|||
0333|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0333|002|Z|does NOT have all possible information about this product. This||
0333|003|Z|information does not assure that this product is safe, effective,||
0333|004|Z|or appropriate for you. This information is not individual||
0333|005|Z|medical advice and does not substitute for the advice of your||
0333|006|Z|health care professional. Always ask your health care||
0333|007|Z|professional for complete information about this product and your||
0333|008|Z|specific health needs.||
0333|009|B|||
0333|010|T|CLOBETASOL FOAM - TOPICAL||
0333|011|F|(kloe-BAY-ta-sol)||
0333|012|B|||
0333|013|C|COMMON BRAND NAME(S): Olux||
0333|014|B|||
0333|015|U|USES:  Clobetasol is used to treat certain scalp and skin||
0333|016|U|conditions (such as psoriasis, dermatitis, rash). Clobetasol||
0333|017|U|reduces the swelling, itching and redness that can occur in these||
0333|018|U|types of conditions. This medication is a very strong||
0333|019|U|(super-high-potency) corticosteroid.||
0333|020|B|||
0333|021|H|HOW TO USE:  Apply this medication to the scalp as directed by||
0333|022|H|your doctor, usually twice daily (in the morning and evening).||
0333|023|H|   Learn all preparation and usage instructions in the product||
0333|024|H|package, and ask your doctor or pharmacist if you have questions||
0333|025|H|about any of the information.||
0333|026|H|   Use this medication only on the skin. However, do not use it||
0333|027|H|on the face, groin or underarms unless directed to do so by your||
0333|028|H|doctor.||
0333|029|H|   Wash and dry your hands before applying. Apply the prescribed||
0333|030|H|amount of medication to the affected area and gently rub in. Do||
0333|031|H|not bandage, wrap or cover the area unless directed to do so by||
0333|032|H|your doctor.||
0333|033|H|   After applying the medication, wash your hands, unless you are||
0333|034|H|using this medication to treat the hands. If applying this||
0333|035|H|medication near the eyes, avoid getting it in the eyes because||
0333|036|H|this may worsen or cause glaucoma. Also, avoid getting the||
0333|037|H|medication in your nose or mouth. If you get the medication in||
0333|038|H|your eyes, nose, or mouth, rinse with plenty of water.||
0333|039|H|   Use this medication exactly as prescribed. Do not increase||
0333|040|H|your dose, take it more often, or use it for longer than 2 weeks||
0333|041|H|in a row. Do not apply more than one 50-gram can in a given week||
0333|042|H|unless directed by your doctor. Doing so could increase your risk||
0333|043|H|of side effects.||
0333|044|H|   Tell your doctor if your condition lasts or gets worse after 2||
0333|045|H|weeks.||
0333|046|B|||
0333|047|S|SIDE EFFECTS:  Burning, stinging, itching, irritation, dryness,||
0333|048|S|or redness may occur when this medication is first applied to the||
0333|049|S|scalp/skin. This should disappear in a few days as your body||
0333|050|S|adjusts to the medication. If any of these effects last or get||
0333|051|S|worse, notify your doctor or pharmacist promptly.||
0333|052|S|   Remember that this medication has been prescribed because your||
0333|053|S|doctor has judged that the benefit to you is greater than the||
0333|054|S|risk of side effects. Many people using this medication do not||
0333|055|S|have serious side effects.||
0333|056|S|   Tell your doctor right away if you have any serious side||
0333|057|S|effects, including: stretch marks (striae), skin||
0333|058|S|thinning/discoloration, excessive hair growth, acne, small red||
0333|059|S|bumps on the skin (folliculitis).||
0333|060|S|   Skin infections can become worse when using this medication.||
0333|061|S|Notify your doctor if redness, swelling or irritation does not||
0333|062|S|improve.||
0333|063|S|   Rarely, it is possible this medication will be absorbed from||
0333|064|S|the skin into the bloodstream. This can lead to side effects of||
0333|065|S|too much corticosteroid. These side effects are more likely in||
0333|066|S|children, and in people who use this medication for a long time||
0333|067|S|or over large areas of the skin. Tell your doctor right away if||
0333|068|S|any of the following side effects occur: unusual/extreme||
0333|069|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0333|070|S|thirst/urination, vision problems.||
0333|071|S|   A very serious allergic reaction to this drug is rare.||
0333|072|S|However, get medical help right away if you notice any symptoms||
0333|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0333|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0333|075|S|breathing.||
0333|076|S|   This is not a complete list of possible side effects. If you||
0333|077|S|notice other effects not listed above, contact your doctor or||
0333|078|S|pharmacist.||
0333|079|S|   In the US -||
0333|080|S|   Call your doctor for medical advice about side effects. You||
0333|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0333|082|S|www.fda.gov/medwatch.||
0333|083|S|   In Canada - Call your doctor for medical advice about side||
0333|084|S|effects. You may report side effects to Health Canada at||
0333|085|S|1-866-234-2345.||
0333|086|B|||
0333|087|P|PRECAUTIONS:  Before using clobetasol, tell your doctor or||
0333|088|P|pharmacist if you are allergic to it; or to any other steroids||
0333|089|P|(such as hydrocortisone, dexamethasone); or if you have any other||
0333|090|P|allergies. This product may contain inactive ingredients, which||
0333|091|P|can cause allergic reactions or other problems. Talk to your||
0333|092|P|pharmacist for more details.||
0333|093|P|   Before using this medication, tell your doctor or pharmacist||
0333|094|P|your medical history, especially of: poor blood circulation,||
0333|095|P|diabetes, other skin/scalp conditions (such as rosacea, perioral||
0333|096|P|dermatitis), immune system problems.||
0333|097|P|   Do not use if there is an infection or sore in the area to be||
0333|098|P|treated.||
0333|099|P|   Rarely, using corticosteroid medications for a long time or||
0333|100|P|over large areas of skin can make it more difficult for your body||
0333|101|P|to respond to physical stress. Before having surgery or emergency||
0333|102|P|treatment, or if you get a serious illness/injury, tell your||
0333|103|P|doctor or dentist that you are using this medication or have used||
0333|104|P|this medication within the past few months.||
0333|105|P|   Though it is unlikely, this medication may temporarily slow||
0333|106|P|down a child's growth if used for a long time. See the doctor||
0333|107|P|regularly so your child's height can be checked.||
0333|108|P|   During pregnancy, this medication should be used only when||
0333|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
0333|110|P|   It is unknown if this drug passes into breast milk when||
0333|111|P|applied to the scalp/skin. Similar medications pass into breast||
0333|112|P|milk when taken by mouth. Consult your doctor before||
0333|113|P|breastfeeding.||
0333|114|B|||
0333|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0333|116|I|medications work or increase your risk for serious side effects.||
0333|117|I|This document does not contain all possible drug interactions.||
0333|118|I|Keep a list of all the products you use (including||
0333|119|I|prescription/nonprescription drugs and herbal products) and share||
0333|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
0333|121|I|the dosage of any medicines without your doctor's approval.||
0333|122|B|||
0333|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0333|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0333|125|O|poison control center right away. US residents can call||
0333|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0333|127|O|medicine may be harmful if swallowed.||
0333|128|B|||
0333|129|N|NOTES:  Do not share this medication with others. This medication||
0333|130|N|has been prescribed for your current condition only. Do not use||
0333|131|N|it later for other skin problems unless told to do so by your||
0333|132|N|doctor. A different medication may be necessary in those cases.||
0333|133|N|   Lab and/or medical tests (such as adrenal gland function) may||
0333|134|N|be done while you are using this medication, especially if you||
0333|135|N|use this drug for an extended period of time or apply it over||
0333|136|N|large areas of the body. Keep all medical and lab appointments.||
0333|137|N|Consult your doctor for more details.||
0333|138|B|||
0333|139|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0333|140|D|If it is near the time of the next dose, skip the missed dose.||
0333|141|D|Use your next dose at the regular time. Do not double the dose to||
0333|142|D|catch up.||
0333|143|B|||
0333|144|R|STORAGE:  Store at room temperature away from heat and open||
0333|145|R|flame. Do not puncture the can. Keep all medications away from||
0333|146|R|children and pets.||
0333|147|R|   Do not flush medications down the toilet or pour them into a||
0333|148|R|drain unless instructed to do so. Properly discard this product||
0333|149|R|when it is expired or no longer needed. Consult your pharmacist||
0333|150|R|or local waste disposal company.||
0333|151|B|||
0333|152|A|Information last revised October 2024.||
0333|153|A|Copyright(c) 2025 First Databank, Inc.||
0333|154|B|||
0335|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0335|002|Z|does NOT have all possible information about this product. This||
0335|003|Z|information does not assure that this product is safe, effective,||
0335|004|Z|or appropriate for you. This information is not individual||
0335|005|Z|medical advice and does not substitute for the advice of your||
0335|006|Z|health care professional. Always ask your health care||
0335|007|Z|professional for complete information about this product and your||
0335|008|Z|specific health needs.||
0335|009|B|||
0335|010|T|LEUPROLIDE MONTHLY PEDIATRIC - INJECTION||
0335|011|F|(LOO-proe-lide)||
0335|012|B|||
0335|013|C|COMMON BRAND NAME(S): Lupron Depot-Ped||
0335|014|B|||
0335|015|U|USES:  Leuprolide is used to stop early puberty (precocious||
0335|016|U|puberty) in children. It helps to delay sexual development (such||
0335|017|U|as growth of the breasts/testicles) and the start of menstrual||
0335|018|U|periods. It also helps slow down early bone growth to increase||
0335|019|U|the likelihood of reaching normal adult height. Leuprolide works||
0335|020|U|by decreasing the amount of sex hormones that a child's body||
0335|021|U|makes (estrogen in girls, testosterone in boys).||
0335|022|B|||
0335|023|V|OTHER USES:  This section contains uses of this drug that are not||
0335|024|V|listed in the approved professional labeling for the drug but||
0335|025|V|that may be prescribed by your health care professional. Use this||
0335|026|V|drug for a condition that is listed in this section only if it||
0335|027|V|has been so prescribed by your health care professional.||
0335|028|V|   This drug may also be used for gender dysphoria.||
0335|029|B|||
0335|030|H|HOW TO USE:  Read the Medication Guide provided by your||
0335|031|H|pharmacist before you start using leuprolide and each time you||
0335|032|H|get a refill. If you have any questions, ask your doctor or||
0335|033|H|pharmacist.||
0335|034|H|   This medication is given by injection into a muscle by a||
0335|035|H|health care professional as directed by the doctor, usually once||
0335|036|H|a month. This product slowly releases the medication into the||
0335|037|H|blood over a 1-month period.||
0335|038|H|   Children's dosage is based on weight and response to||
0335|039|H|treatment. The doctor should consider stopping treatment before||
0335|040|H|age 11 for girls and age 12 for boys. Consult the doctor for||
0335|041|H|details.||
0335|042|H|   Use this medication regularly to get the most benefit from it.||
0335|043|H|To help you remember, mark your calendar with a reminder.||
0335|044|H|   During the first few weeks of treatment, hormone levels will||
0335|045|H|actually go up before they go down. This is a normal response to||
0335|046|H|this medication. You may notice worsening symptoms of early||
0335|047|H|puberty (such as menstrual periods) at the start of treatment.||
0335|048|H|However, you should see an improvement in symptoms usually within||
0335|049|H|1 to 2 months. Tell the doctor promptly if new or worsened||
0335|050|H|symptoms develop after starting treatment.||
0335|051|B|||
0335|052|S|SIDE EFFECTS:  Hot flashes (flushing), headache, breast changes,||
0335|053|S|acne/seborrhea, vaginal discomfort/dryness, vaginal||
0335|054|S|bleeding/discharge, or mild pain/irritation at the injection site||
0335|055|S|may occur. If any of these effects last or get worse, tell the||
0335|056|S|doctor or pharmacist promptly.||
0335|057|S|   When this medication is used regularly, it is expected that||
0335|058|S|the menstrual period will stop or decrease to light||
0335|059|S|bleeding/spotting during the first 2 months. Tell the doctor||
0335|060|S|promptly if regular periods continue after 2 months of treatment||
0335|061|S|with leuprolide.||
0335|062|S|   Remember that this medication has been prescribed because the||
0335|063|S|doctor has judged that the benefit is greater than the risk of||
0335|064|S|side effects. Many people using this medication do not have||
0335|065|S|serious side effects.||
0335|066|S|   Tell your doctor right away if you have any serious side||
0335|067|S|effects, including: mental/mood changes (such as non-stop crying,||
0335|068|S|irritability, mood swings, aggression).||
0335|069|S|   Get medical help right away if you have any very serious side||
0335|070|S|effects, including: seizures.||
0335|071|S|   Children using leuprolide may be at risk for increased||
0335|072|S|pressure around the brain (intracranial hypertension). Get||
0335|073|S|medical help right away if your child has any of these very||
0335|074|S|serious side effects: nausea/vomiting that doesn't stop, headache||
0335|075|S|that is severe or doesn't go away, eye pain, vision changes (such||
0335|076|S|as blurred/double vision, decreased vision), ringing in the ears.||
0335|077|S|   A very serious allergic reaction to this drug is rare.||
0335|078|S|However, get medical help right away if you notice any symptoms||
0335|079|S|of a serious allergic reaction, including: fever, swollen lymph||
0335|080|S|nodes, rash, itching/swelling (especially of the||
0335|081|S|face/tongue/throat), severe dizziness, trouble breathing.||
0335|082|S|   This is not a complete list of possible side effects. If you||
0335|083|S|notice other effects not listed above, contact the doctor or||
0335|084|S|pharmacist.||
0335|085|S|   In the US -||
0335|086|S|   Call your doctor for medical advice about side effects. You||
0335|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0335|088|S|www.fda.gov/medwatch.||
0335|089|S|   In Canada - Call your doctor for medical advice about side||
0335|090|S|effects. You may report side effects to Health Canada at||
0335|091|S|1-866-234-2345.||
0335|092|B|||
0335|093|P|PRECAUTIONS:  Before using leuprolide, tell the doctor or||
0335|094|P|pharmacist if your child is allergic to it; or to similar drugs||
0335|095|P|(such as histrelin, triptorelin); or if your child has any other||
0335|096|P|allergies. This product may contain inactive ingredients, which||
0335|097|P|can cause allergic reactions or other problems. Talk to the||
0335|098|P|pharmacist for more details.||
0335|099|P|   Before using this medication, tell the doctor or pharmacist||
0335|100|P|the child's medical history, especially of: mental/mood problems||
0335|101|P|(such as depression), seizures.||
0335|102|P|   Before having surgery, tell the doctor or dentist about all||
0335|103|P|the products being used (including prescription drugs,||
0335|104|P|nonprescription drugs, and herbal products).||
0335|105|P|   This medication must not be used during pregnancy. It may harm||
0335|106|P|an unborn baby. Consult your doctor for more details and to||
0335|107|P|discuss using reliable forms of non-hormonal birth control (such||
0335|108|P|as condoms, diaphragm with spermicide) while using this||
0335|109|P|medication. If you become pregnant or think you may be pregnant,||
0335|110|P|tell your doctor right away.||
0335|111|P|   It is unknown if leuprolide passes into breast milk. Because||
0335|112|P|of the possible risk to the infant, breastfeeding is not||
0335|113|P|recommended while using this medication. Consult your doctor||
0335|114|P|before breastfeeding.||
0335|115|B|||
0335|116|I|DRUG INTERACTIONS:  Drug interactions may change how medications||
0335|117|I|work or increase the risk for serious side effects. This document||
0335|118|I|does not contain all possible drug interactions. Keep a list of||
0335|119|I|all the products your child uses (including||
0335|120|I|prescription/nonprescription drugs and herbal products) and share||
0335|121|I|it with the doctor and pharmacist. Do not start, stop, or change||
0335|122|I|the dosage of any medicines without the doctor's approval.||
0335|123|I|   This medication may interfere with certain lab tests possibly||
0335|124|I|causing false test results. Make sure lab personnel and all the||
0335|125|I|doctors know your child uses this drug.||
0335|126|B|||
0335|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0335|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0335|129|O|poison control center right away. US residents can call||
0335|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0335|131|B|||
0335|132|N|NOTES:  Do not share this medication with others.||
0335|133|N|   Lab and/or medical tests (such as hormone levels, height||
0335|134|N|measurements, bone tests) should be done while using this||
0335|135|N|medication. Keep all medical and lab appointments. Consult the||
0335|136|N|doctor for more details.||
0335|137|B|||
0335|138|D|MISSED DOSE:  It is important to get each dose of this medication||
0335|139|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0335|140|D|right away for a new dosing schedule. Do not double the dose to||
0335|141|D|catch up.||
0335|142|B|||
0335|143|R|STORAGE:  Not applicable. This medication is given in a clinic or||
0335|144|R|doctor's office and will not be stored at home.||
0335|145|B|||
0335|146|A|Information last revised October 2024.||
0335|147|A|Copyright(c) 2025 First Databank, Inc.||
0335|148|B|||
0337|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0337|002|Z|does NOT have all possible information about this product. This||
0337|003|Z|information does not assure that this product is safe, effective,||
0337|004|Z|or appropriate for you. This information is not individual||
0337|005|Z|medical advice and does not substitute for the advice of your||
0337|006|Z|health care professional. Always ask your health care||
0337|007|Z|professional for complete information about this product and your||
0337|008|Z|specific health needs.||
0337|009|B|||
0337|010|T|MAGNESIUM SALICYLATE - ORAL||
0337|011|F|(mag-NEE-zee-um sa-LIS-i-late)||
0337|012|B|||
0337|013|C|COMMON BRAND NAME(S): Doan's||
0337|014|B|||
0337|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0337|016|W|magnesium salicylate) may rarely increase the risk for a heart||
0337|017|W|attack or stroke. This effect can happen at any time while taking||
0337|018|W|this drug but is more likely if you take it for a long time. The||
0337|019|W|risk may be greater in older adults or if you have heart disease||
0337|020|W|or increased risk for heart disease (for example, due to smoking,||
0337|021|W|family history of heart disease, or conditions such as high blood||
0337|022|W|pressure or diabetes). Do not take this drug right before or||
0337|023|W|after heart bypass surgery (CABG).||
0337|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0337|025|W|bleeding from the stomach or intestines. This effect can occur||
0337|026|W|without warning symptoms at any time while taking this drug.||
0337|027|W|Older adults may be at higher risk for this effect.||
0337|028|W|   Stop taking this medication and get medical help right away if||
0337|029|W|you notice any of these rare but serious side effects:||
0337|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0337|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0337|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0337|033|W|side of the body, trouble speaking, sudden vision changes.||
0337|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0337|035|W|of taking this drug.||
0337|036|B|||
0337|037|U|USES:  Magnesium salicylate is used to relieve pain from various||
0337|038|U|conditions. It also reduces pain, swelling, and joint stiffness||
0337|039|U|from arthritis. This medication is known as a nonsteroidal||
0337|040|U|anti-inflammatory drug (NSAID).||
0337|041|B|||
0337|042|H|HOW TO USE:  If you are taking the over-the-counter product, read||
0337|043|H|all directions on the product package before taking this||
0337|044|H|medication. Take this medication by mouth, usually 3 to 4 times||
0337|045|H|daily with a full glass of water (8 ounces or 240 milliliters) or||
0337|046|H|as directed by your doctor. Do not lie down for at least 10||
0337|047|H|minutes after taking this drug. If stomach upset occurs while||
0337|048|H|taking this medication, take it with food, milk, or an antacid.||
0337|049|H|   The dosage is based on your medical condition and response to||
0337|050|H|treatment. To reduce your risk of stomach bleeding and other side||
0337|051|H|effects, take this medication at the lowest effective dose for||
0337|052|H|the shortest possible time. Do not increase your dose, take it||
0337|053|H|more often, or take it for a longer time than prescribed. Do not||
0337|054|H|take the over-the-counter product for more than 10 days unless||
0337|055|H|otherwise directed. For ongoing conditions such as arthritis,||
0337|056|H|keep taking this medication as directed by your doctor. Discuss||
0337|057|H|the risks and benefits with your doctor or pharmacist.||
0337|058|H|   For certain conditions (such as arthritis), it may take up to||
0337|059|H|2 weeks of taking this drug regularly until you get the full||
0337|060|H|benefit.||
0337|061|H|   If you are taking this drug "as needed" (not on a regular||
0337|062|H|schedule), remember that pain medications work best if they are||
0337|063|H|used as the first signs of pain occur. If you wait until the||
0337|064|H|symptoms have worsened, the medicine may not work as well.||
0337|065|H|   Tell your doctor if your condition lasts or gets worse, or if||
0337|066|H|you develop new symptoms. If you think you may have a serious||
0337|067|H|medical problem, get medical help right away.||
0337|068|B|||
0337|069|S|SIDE EFFECTS:  Upset stomach or nausea may occur. If any of these||
0337|070|S|effects last or get worse, notify your doctor or pharmacist||
0337|071|S|promptly.||
0337|072|S|   If your doctor has directed you to use this medication,||
0337|073|S|remember that your doctor has judged that the benefit to you is||
0337|074|S|greater than the risk of side effects. Many people using this||
0337|075|S|medication do not have serious side effects.||
0337|076|S|   This medication may raise your blood pressure. Check your||
0337|077|S|blood pressure regularly and tell your doctor if the results are||
0337|078|S|high.||
0337|079|S|   Tell your doctor right away if you have any serious side||
0337|080|S|effects, including: heartburn, swelling of ankles/feet/hands,||
0337|081|S|sudden/unexplained weight gain, hearing changes (such as ringing||
0337|082|S|in the ears, decreased hearing), fast/pounding heartbeat,||
0337|083|S|unusual/extreme tiredness, signs of kidney problems (such as||
0337|084|S|change in the amount of urine), easy bruising/bleeding.||
0337|085|S|   This drug may rarely cause serious (possibly fatal) liver||
0337|086|S|disease. Get medical help right away if you have any symptoms of||
0337|087|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0337|088|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0337|089|S|urine.||
0337|090|S|   A very serious allergic reaction to this drug is rare.||
0337|091|S|However, get medical help right away if you notice any symptoms||
0337|092|S|of a serious allergic reaction, including: fever, swollen lymph||
0337|093|S|nodes, rash, itching/swelling (especially of the||
0337|094|S|face/tongue/throat), severe dizziness, trouble breathing.||
0337|095|S|   This is not a complete list of possible side effects. If you||
0337|096|S|notice any other side effects not listed above, contact your||
0337|097|S|doctor or pharmacist.||
0337|098|S|   In the US -||
0337|099|S|   Call your doctor for medical advice about side effects. You||
0337|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0337|101|S|www.fda.gov/medwatch.||
0337|102|S|   In Canada - Call your doctor for medical advice about side||
0337|103|S|effects. You may report side effects to Health Canada at||
0337|104|S|1-866-234-2345.||
0337|105|B|||
0337|106|P|PRECAUTIONS:  Before taking magnesium salicylate, tell your||
0337|107|P|doctor or pharmacist if you are allergic to it; or to aspirin or||
0337|108|P|other NSAIDs (such as ibuprofen, naproxen, salsalate); or if you||
0337|109|P|have any other allergies. This product may contain inactive||
0337|110|P|ingredients, which can cause allergic reactions or other||
0337|111|P|problems. Talk to your pharmacist for more details.||
0337|112|P|   Before using this medication, tell your doctor or pharmacist||
0337|113|P|your medical history, especially of: asthma (including a history||
0337|114|P|of worsening breathing after taking aspirin or other NSAIDs),||
0337|115|P|kidney disease, liver disease, diabetes,||
0337|116|P|stomach/intestine/esophagus problems (such as bleeding, ulcers,||
0337|117|P|recurring heartburn), heart disease (such as heart failure,||
0337|118|P|history of heart attack), high blood pressure, stroke, swelling||
0337|119|P|of the ankles/feet/hands, dehydration, blood disorders (such as||
0337|120|P|anemia), bleeding/clotting problems, growths in the nose (nasal||
0337|121|P|polyps), certain genetic conditions (G-6-PD deficiency, pyruvate||
0337|122|P|kinase deficiency).||
0337|123|P|   Before having surgery, tell your doctor or dentist about all||
0337|124|P|the products you use (including prescription drugs,||
0337|125|P|nonprescription drugs, and herbal products).||
0337|126|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0337|127|P|and tobacco, especially when combined with this medicine, may||
0337|128|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0337|129|P|smoking. Consult your doctor or pharmacist for more information.||
0337|130|P|   Older adults may be at greater risk for stomach bleeding and||
0337|131|P|kidney effects.||
0337|132|P|   This medication is similar to aspirin. Children and teenagers||
0337|133|P|younger than 18 years should not take this medication if they||
0337|134|P|have chickenpox, flu, or any undiagnosed illness, or if they have||
0337|135|P|just been given a live virus vaccine, without first consulting a||
0337|136|P|doctor about Reye's syndrome, a rare but serious illness.||
0337|137|P|   Tell your doctor if you are pregnant or if you plan to become||
0337|138|P|pregnant. This medication may harm an unborn baby and cause||
0337|139|P|problems with normal labor/delivery. It is not recommended for||
0337|140|P|use in pregnancy from 20 weeks until delivery. If your doctor||
0337|141|P|decides that you need to use this medication between 20 and 30||
0337|142|P|weeks of pregnancy, you should use the lowest effective dose for||
0337|143|P|the shortest possible time. You should not use this medication||
0337|144|P|after 30 weeks of pregnancy. Discuss the risks and benefits with||
0337|145|P|your doctor.||
0337|146|P|   This drug may pass into breast milk and could have undesirable||
0337|147|P|effects on a nursing infant. Breastfeeding is not recommended||
0337|148|P|while using this drug. Consult your doctor before breastfeeding.||
0337|149|B|||
0337|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0337|151|I|medications work or increase your risk for serious side effects.||
0337|152|I|This document does not contain all possible drug interactions.||
0337|153|I|Keep a list of all the products you use (including||
0337|154|I|prescription/nonprescription drugs and herbal products) and share||
0337|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
0337|156|I|the dosage of any medicines without your doctor's approval.||
0337|157|I|   Some products that may interact with this drug include:||
0337|158|I|anabolic steroids (such as danazol, oxandrolone), carbonic||
0337|159|I|anhydrase inhibitors (such as acetazolamide), certain drugs for||
0337|160|I|seizures (phenytoin, phenobarbital, valproic acid), cidofovir,||
0337|161|I|corticosteroids (such as prednisone), dichlorphenamide, drugs for||
0337|162|I|gout (such as probenecid), gabapentin, lithium,||
0337|163|I|magnesium-containing drugs (such as milk of magnesia),||
0337|164|I|methotrexate, pemetrexed, tenofovir.||
0337|165|I|   This medication may increase the risk of bleeding when taken||
0337|166|I|with other drugs that also may cause bleeding. Examples include||
0337|167|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0337|168|I|dabigatran/enoxaparin/warfarin, among others.||
0337|169|I|   Check all prescription and nonprescription medicine labels||
0337|170|I|carefully since many contain pain relievers/fever reducers||
0337|171|I|(NSAIDs such as aspirin, ibuprofen, ketorolac, or naproxen) that||
0337|172|I|are similar to this drug and, if taken together, may increase||
0337|173|I|your risk for side effects. However, if your doctor has told you||
0337|174|I|to take low-dose aspirin to prevent heart attack or stroke||
0337|175|I|(usually 81-162 milligrams a day), you should keep taking the||
0337|176|I|aspirin unless your doctor tells you not to. Ask your doctor or||
0337|177|I|pharmacist for more details.||
0337|178|I|   The magnesium in this product can decrease the absorption of||
0337|179|I|certain drugs, especially if you take them around the same time.||
0337|180|I|These drugs include bisphosphonates (such as alendronate),||
0337|181|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
0337|182|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
0337|183|I|minocycline), thyroid medications (such as levothyroxine), among||
0337|184|I|others. Ask your doctor or pharmacist how long you should wait||
0337|185|I|between doses of this product and your other medications and to||
0337|186|I|find a dosing schedule that works for all your medications.||
0337|187|I|   This medication may interfere with certain lab tests (such as||
0337|188|I|certain urine glucose tests), possibly causing false test||
0337|189|I|results. Make sure lab personnel and all your doctors know you||
0337|190|I|use this drug.||
0337|191|B|||
0337|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0337|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0337|194|O|poison control center right away. US residents can call||
0337|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0337|196|O|Symptoms of overdose may include: dizziness, ringing in the ears,||
0337|197|O|weakness, nausea, vomiting, drowsiness, fast breathing,||
0337|198|O|confusion, seizures.||
0337|199|B|||
0337|200|N|NOTES:  If your doctor has prescribed this medication for you, do||
0337|201|N|not share it with others.||
0337|202|N|   If your doctor has instructed you to take this medication||
0337|203|N|regularly, lab and/or medical tests (such as blood pressure,||
0337|204|N|complete blood count, liver/kidney function, magnesium levels)||
0337|205|N|may be done while you are taking this medication. Keep all||
0337|206|N|medical and lab appointments. Consult your doctor for more||
0337|207|N|details.||
0337|208|N|   If you have arthritis, lifestyle changes (such as weight loss||
0337|209|N|if needed, strengthening/conditioning exercises) may help improve||
0337|210|N|your flexibility and joint function. Consult your doctor for||
0337|211|N|specific instructions.||
0337|212|B|||
0337|213|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
0337|214|D|(not "as needed") and you miss a dose, take it as soon as you||
0337|215|D|remember. If it is near the time of the next dose, skip the||
0337|216|D|missed dose. Take your next dose at the regular time. Do not||
0337|217|D|double the dose to catch up.||
0337|218|B|||
0337|219|R|STORAGE:  Store at room temperature away from light and moisture.||
0337|220|R|Do not store in the bathroom. Keep all medications away from||
0337|221|R|children and pets.||
0337|222|R|   Do not flush medications down the toilet or pour them into a||
0337|223|R|drain unless instructed to do so. Properly discard this product||
0337|224|R|when it is expired or no longer needed. Consult your pharmacist||
0337|225|R|or local waste disposal company.||
0337|226|B|||
0337|227|A|Information last revised October 2025.||
0337|228|A|Copyright(c) 2025 First Databank, Inc.||
0337|229|B|||
0338|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0338|002|Z|does NOT have all possible information about this product. This||
0338|003|Z|information does not assure that this product is safe, effective,||
0338|004|Z|or appropriate for you. This information is not individual||
0338|005|Z|medical advice and does not substitute for the advice of your||
0338|006|Z|health care professional. Always ask your health care||
0338|007|Z|professional for complete information about this product and your||
0338|008|Z|specific health needs.||
0338|009|B|||
0338|010|T|CARMUSTINE/POLIFEPROSAN 20 - IMPLANT||
0338|011|F|(kar-MUS-teen/POL-ee-FEP-roe-san)||
0338|012|B|||
0338|013|C|COMMON BRAND NAME(S): Gliadel||
0338|014|B|||
0338|015|U|USES:  This medication is an implant used to treat certain types||
0338|016|U|of brain tumors (such as malignant glioma). The implant is a||
0338|017|U|combination product (wafer) made of carmustine and polifeprosan||
0338|018|U|20. Carmustine belongs to a class of drugs known as alkylating||
0338|019|U|agents. It works by slowing or stopping the growth of cancer||
0338|020|U|cells. Polifeprosan 20 helps control the release of carmustine in||
0338|021|U|the brain.||
0338|022|B|||
0338|023|H|HOW TO USE:  This implant is placed in the space left after||
0338|024|H|surgery to remove a brain tumor. The implant will slowly dissolve||
0338|025|H|and release the medication in your brain.||
0338|026|H|   The number of implants (wafers) placed is based on the amount||
0338|027|H|of space in the brain. Usually, up to 8 wafers may be placed at||
0338|028|H|one time during surgery.||
0338|029|B|||
0338|030|S|SIDE EFFECTS:  Nausea, vomiting, constipation, or abdominal/back||
0338|031|S|pain may occur. If any of these effects last or get worse, tell||
0338|032|S|your doctor or pharmacist promptly.||
0338|033|S|   People using this medication may have serious side effects.||
0338|034|S|However, you have been prescribed this drug because your doctor||
0338|035|S|has judged that the benefit to you is greater than the risk of||
0338|036|S|side effects. Careful monitoring by your doctor may decrease your||
0338|037|S|risk.||
0338|038|S|   Tell your doctor right away if you have any serious side||
0338|039|S|effects, including: swelling/redness/warmth or poor healing at||
0338|040|S|surgery site, signs of infection (such as sore throat that||
0338|041|S|doesn't go away, fever, chills, stiff neck), chest pain,||
0338|042|S|mental/mood changes (such as depression, anxiety), weakness.||
0338|043|S|   Get medical help right away if you have any very serious side||
0338|044|S|effects, including: seizure, signs of increased pressure around||
0338|045|S|the brain (such as severe headache, confusion, vision changes).||
0338|046|S|   A very serious allergic reaction to this drug is rare.||
0338|047|S|However, get medical help right away if you notice any symptoms||
0338|048|S|of a serious allergic reaction, including: rash, itching/swelling||
0338|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0338|050|S|breathing.||
0338|051|S|   This is not a complete list of possible side effects. If you||
0338|052|S|notice any other effects not listed above, contact your doctor or||
0338|053|S|pharmacist.||
0338|054|S|   In the US -||
0338|055|S|   Call your doctor for medical advice about side effects. You||
0338|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0338|057|S|www.fda.gov/medwatch.||
0338|058|S|   In Canada - Call your doctor for medical advice about side||
0338|059|S|effects. You may report side effects to Health Canada at||
0338|060|S|1-866-234-2345.||
0338|061|B|||
0338|062|P|PRECAUTIONS:  Before receiving carmustine/polifeprosan 20, tell||
0338|063|P|your doctor or pharmacist if you are allergic to it; or if you||
0338|064|P|have any other allergies. This product may contain inactive||
0338|065|P|ingredients, which can cause allergic reactions or other||
0338|066|P|problems. Talk to your pharmacist for more details.||
0338|067|P|   Before using this medication, tell your doctor or pharmacist||
0338|068|P|your medical history.||
0338|069|P|   Before having surgery, tell your doctor or dentist about all||
0338|070|P|the products you use (including prescription drugs,||
0338|071|P|nonprescription drugs, and herbal products).||
0338|072|P|   Tell your doctor if you are pregnant or plan to become||
0338|073|P|pregnant. You should not become pregnant while using carmustine.||
0338|074|P|Carmustine may harm an unborn baby. Women should ask about||
0338|075|P|reliable forms of birth control for at least 6 months after the||
0338|076|P|implant is placed. Men should ask about reliable forms of birth||
0338|077|P|control for at least 3 months after the implant is placed. If you||
0338|078|P|or your partner becomes pregnant, talk to your doctor right away||
0338|079|P|about the risks and benefits of this medication.||
0338|080|P|   It is unknown if this medication passes into breast milk.||
0338|081|P|Because of the possible risk to the infant, breastfeeding is not||
0338|082|P|recommended for at least 7 days after the implant is placed.||
0338|083|P|Consult your doctor before breastfeeding.||
0338|084|B|||
0338|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0338|086|I|medications work or increase your risk for serious side effects.||
0338|087|I|This document does not contain all possible drug interactions.||
0338|088|I|Keep a list of all the products you use (including||
0338|089|I|prescription/nonprescription drugs and herbal products) and share||
0338|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
0338|091|I|the dosage of any medicines without your doctor's approval.||
0338|092|B|||
0338|093|O|OVERDOSE:  This medication may be harmful if swallowed. If||
0338|094|O|someone has swallowed it and has serious symptoms such as passing||
0338|095|O|out or trouble breathing, call 911. Otherwise, call a poison||
0338|096|O|control center right away. US residents can call 1-800-222-1222.||
0338|097|O|Canada residents can call 1-844-764-7669.||
0338|098|B|||
0338|099|N|NOTES:  Lab and/or medical tests should be done while you are||
0338|100|N|using this medication. Keep all medical and lab appointments.||
0338|101|B|||
0338|102|D|MISSED DOSE:  Not applicable.||
0338|103|B|||
0338|104|R|STORAGE:  Not applicable. This product is used in a hospital and||
0338|105|R|will not be stored at home.||
0338|106|B|||
0338|107|A|Information last revised April 2025.||
0338|108|A|Copyright(c) 2025 First Databank, Inc.||
0338|109|B|||
0340|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0340|002|Z|does NOT have all possible information about this product. This||
0340|003|Z|information does not assure that this product is safe, effective,||
0340|004|Z|or appropriate for you. This information is not individual||
0340|005|Z|medical advice and does not substitute for the advice of your||
0340|006|Z|health care professional. Always ask your health care||
0340|007|Z|professional for complete information about this product and your||
0340|008|Z|specific health needs.||
0340|009|B|||
0340|010|T|CETRORELIX - INJECTION||
0340|011|F|(SE-troe-REL-ix)||
0340|012|B|||
0340|013|C|COMMON BRAND NAME(S): Cetrotide||
0340|014|B|||
0340|015|U|USES:  This medication is used by women having certain fertility||
0340|016|U|treatments (controlled ovarian stimulation). Cetrorelix is||
0340|017|U|usually used in combination with other hormones (FSH and hCG). It||
0340|018|U|works by blocking the release of a certain hormone (luteinizing||
0340|019|U|hormone). Cetrorelix stops eggs from being released too early and||
0340|020|U|gives the eggs time to grow properly.||
0340|021|B|||
0340|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0340|023|H|from your pharmacist before you start using cetrorelix and each||
0340|024|H|time you get a refill. Ask your health care professional how to||
0340|025|H|prepare and use this medication. If you have any questions, ask||
0340|026|H|your doctor or pharmacist.||
0340|027|H|   Inject this medication under the skin as directed by your||
0340|028|H|doctor, usually once a day for several days. The injection is||
0340|029|H|given in the stomach area, at least one inch away from the belly||
0340|030|H|button. Carefully follow your doctor's instructions on when to||
0340|031|H|start and stop this medication.||
0340|032|H|    Follow the instructions for adding the mixing liquid to the||
0340|033|H|medication. Gently swirl the vial to mix. Once mixed, use the||
0340|034|H|liquid right away.||
0340|035|H|   Before using, check this product for particles or||
0340|036|H|discoloration. If either is present, do not use the liquid.||
0340|037|H|Before injecting each dose, clean the skin you are going to||
0340|038|H|inject into (the injection site) with rubbing alcohol. Change the||
0340|039|H|injection site each time to lessen injury under the skin. To||
0340|040|H|lessen bruising, do not rub the injection site after a shot.||
0340|041|H|Learn how to store and discard medical supplies safely.||
0340|042|H|   Use this medication exactly as directed by your doctor to get||
0340|043|H|the most benefit from it. Do not increase your dose or use this||
0340|044|H|drug more often or for longer than prescribed.||
0340|045|B|||
0340|046|S|SIDE EFFECTS:  Nausea, headache, or||
0340|047|S|pain/bruising/redness/swelling/itching at the injection site may||
0340|048|S|occur. If any of these effects last or get worse, tell your||
0340|049|S|doctor or pharmacist promptly.||
0340|050|S|   Remember that this medication has been prescribed because your||
0340|051|S|doctor has judged that the benefit to you is greater than the||
0340|052|S|risk of side effects. Many people using this medication do not||
0340|053|S|have serious side effects.||
0340|054|S|   This medication may cause a condition known as ovarian||
0340|055|S|hyperstimulation syndrome (OHSS). This condition may occur during||
0340|056|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
0340|057|S|build up in the stomach, chest, and heart area. Get medical help||
0340|058|S|right away if you develop the following side effects: severe pain||
0340|059|S|or swelling in the lower abdominal (pelvic) area, severe||
0340|060|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
0340|061|S|urination.||
0340|062|S|   A very serious allergic reaction to this drug is rare.||
0340|063|S|However, get medical help right away if you notice any symptoms||
0340|064|S|of a serious allergic reaction, such as: rash, itching/swelling||
0340|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0340|066|S|breathing.||
0340|067|S|   This is not a complete list of possible side effects. If you||
0340|068|S|notice any other effects not listed above, contact your doctor or||
0340|069|S|pharmacist.||
0340|070|S|   In the US -||
0340|071|S|   Call your doctor for medical advice about side effects. You||
0340|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0340|073|S|www.fda.gov/medwatch.||
0340|074|S|   In Canada - Call your doctor for medical advice about side||
0340|075|S|effects. You may report side effects to Health Canada at||
0340|076|S|1-866-234-2345.||
0340|077|B|||
0340|078|P|PRECAUTIONS:  Before using cetrorelix, tell your doctor or||
0340|079|P|pharmacist if you are allergic to it; or to other products||
0340|080|P|containing gonadotropin releasing hormone (GnRH); or if you have||
0340|081|P|any other allergies. This product may contain inactive||
0340|082|P|ingredients, which can cause allergic reactions or other||
0340|083|P|problems. Talk to your pharmacist for more details.||
0340|084|P|   Before using this medication, tell your doctor or pharmacist||
0340|085|P|your medical history, especially of: history of severe allergic||
0340|086|P|reactions, kidney disease.||
0340|087|P|   Before having surgery, tell your doctor or dentist about all||
0340|088|P|the products you use (such as prescription drugs, nonprescription||
0340|089|P|drugs, and herbal products).||
0340|090|P|   Stop using this medication when you become pregnant. This||
0340|091|P|medication must not be used during pregnancy. If you think you||
0340|092|P|may be pregnant, tell your doctor right away.||
0340|093|P|   It is unknown if this drug passes into breast milk. Because of||
0340|094|P|the possible risk to the infant, breastfeeding is not recommended||
0340|095|P|while using this drug. Consult your doctor before breastfeeding.||
0340|096|B|||
0340|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0340|098|I|medications work or increase your risk for serious side effects.||
0340|099|I|This document does not contain all possible drug interactions.||
0340|100|I|Keep a list of all the products you use (such as||
0340|101|I|prescription/nonprescription drugs and herbal products) and share||
0340|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
0340|103|I|the dosage of any medicines without your doctor's approval.||
0340|104|B|||
0340|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0340|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0340|107|O|poison control center right away. US residents can call||
0340|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0340|109|B|||
0340|110|N|NOTES:  Do not share this medication with others.||
0340|111|N|   Lab and/or medical tests (such as vaginal ultrasound, hormone||
0340|112|N|levels) may be done while you are using this medication. Keep all||
0340|113|N|medical and lab appointments. Consult your doctor for more||
0340|114|N|details.||
0340|115|B|||
0340|116|D|MISSED DOSE:  It is important to get each dose of this medication||
0340|117|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0340|118|D|right away for a new dosing schedule. Do not double the dose to||
0340|119|D|catch up.||
0340|120|B|||
0340|121|R|STORAGE:  Different brands of this medication have different||
0340|122|R|storage needs. Check the product package for instructions on how||
0340|123|R|to store your brand, or ask your pharmacist. Keep all medications||
0340|124|R|away from children and pets.||
0340|125|R|   Do not flush medications down the toilet or pour them into a||
0340|126|R|drain unless instructed to do so. Properly discard this product||
0340|127|R|when it is expired or no longer needed. Consult your pharmacist||
0340|128|R|or local waste disposal company.||
0340|129|B|||
0340|130|A|Information last revised August 2024.||
0340|131|A|Copyright(c) 2025 First Databank, Inc.||
0340|132|B|||
0341|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0341|002|Z|does NOT have all possible information about this product. This||
0341|003|Z|information does not assure that this product is safe, effective,||
0341|004|Z|or appropriate for you. This information is not individual||
0341|005|Z|medical advice and does not substitute for the advice of your||
0341|006|Z|health care professional. Always ask your health care||
0341|007|Z|professional for complete information about this product and your||
0341|008|Z|specific health needs.||
0341|009|B|||
0341|010|T|INTERFERON GAMMA 1B - INJECTION||
0341|011|F|(IN-ter-FEER-on GAM-ma wun-bee)||
0341|012|B|||
0341|013|C|COMMON BRAND NAME(S): Actimmune||
0341|014|B|||
0341|015|U|USES:  This medication is used to reduce the frequency and||
0341|016|U|severity of serious infections due to chronic granulomatous||
0341|017|U|disease, a disorder that runs in families. This drug is often||
0341|018|U|used along with antibiotics to help prevent these serious||
0341|019|U|infections.||
0341|020|U|   This medication is also used to slow the worsening of||
0341|021|U|malignant osteopetrosis, another disorder that runs in families,||
0341|022|U|that affects bones, nerves, and blood.||
0341|023|U|   This medication is the same as a protein that your body||
0341|024|U|naturally produces (interferon). In the body, it is thought to||
0341|025|U|work by affecting cell function/growth and the body's natural||
0341|026|U|defenses (immune system) in many ways. Adding more interferon may||
0341|027|U|help your body fight off serious infections.||
0341|028|B|||
0341|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0341|030|H|from your pharmacist before you start using this medication and||
0341|031|H|each time you get a refill. If you have any questions, ask your||
0341|032|H|doctor or pharmacist.||
0341|033|H|   This medication is given by injection under the skin as||
0341|034|H|directed by your doctor, usually 3 times weekly (for example,||
0341|035|H|Monday, Wednesday, and Friday). The injection is given in the||
0341|036|H|thighs or upper arms. This medication is best used in the evening||
0341|037|H|before bedtime to reduce side effects. The dosage is based on||
0341|038|H|your body size, medical condition, and response to treatment.||
0341|039|H|   If you are giving this medication to yourself at home, learn||
0341|040|H|all preparation and usage instructions from your health care||
0341|041|H|professional. Do not shake the solution. Before using, check this||
0341|042|H|product for particles or discoloration. If either is present, do||
0341|043|H|not use the liquid. Before injecting each dose, clean the skin||
0341|044|H|you are going to inject into (the injection site) with rubbing||
0341|045|H|alcohol. Change the injection site each time to lessen injury||
0341|046|H|under the skin. Do not inject into skin that is irritated, sore,||
0341|047|H|or infected. To lessen bruising, do not rub the injection site||
0341|048|H|after a shot. Learn how to store and discard medical supplies||
0341|049|H|safely.||
0341|050|H|   Use this medication regularly to get the most benefit from it.||
0341|051|H|To help you remember, use it at the same time each evening that||
0341|052|H|you have a scheduled dose.||
0341|053|B|||
0341|054|S|SIDE EFFECTS:  Injection site reactions (pain/swelling/redness),||
0341|055|S|diarrhea, upset stomach, nausea, or vomiting may occur. If any of||
0341|056|S|these effects last or get worse, tell your doctor or pharmacist||
0341|057|S|promptly.||
0341|058|S|   Flu-like symptoms such as headache, tiredness, fever, chills,||
0341|059|S|and muscle aches may occur, especially when you first start this||
0341|060|S|medication. These symptoms usually last about 1 day after the||
0341|061|S|injection and improve or go away after a few months of continued||
0341|062|S|use. You can reduce these side effects by injecting this medicine||
0341|063|S|at bedtime and using a fever reducer/pain reliever such as||
0341|064|S|acetaminophen before or after each dose. Consult your doctor or||
0341|065|S|pharmacist for more information.||
0341|066|S|   Remember that this medication has been prescribed because your||
0341|067|S|doctor has judged that the benefit to you is greater than the||
0341|068|S|risk of side effects. Many people using this medication do not||
0341|069|S|have serious side effects.||
0341|070|S|   Tell your doctor right away if you have any serious side||
0341|071|S|effects, including: lightheadedness, fainting, mental/mood||
0341|072|S|changes (such as confusion, depression), shaking (tremors),||
0341|073|S|trouble walking, slow/fast/irregular heartbeat, shortness of||
0341|074|S|breath, swelling of the ankles/feet, increasing tiredness, joint||
0341|075|S|pain, butterfly-shaped rash on the face, easy bleeding/bruising,||
0341|076|S|signs of infection (such as sore throat that doesn't go away,||
0341|077|S|fever, chills), signs of liver problems (such as nausea/vomiting||
0341|078|S|that doesn't stop, stomach/abdominal pain, dark urine, yellowing||
0341|079|S|eyes/skin), black/tarry stools, signs of kidney problems (such as||
0341|080|S|change in the amount of urine).||
0341|081|S|   Get medical help right away if you have any very serious side||
0341|082|S|effects, including: chest/jaw/left arm pain, weakness on one side||
0341|083|S|of the body, trouble speaking, sudden vision changes, seizures,||
0341|084|S|pain/redness/swelling of the arms/legs, calf pain/swelling that||
0341|085|S|is warm to the touch, coughing up blood.||
0341|086|S|   A very serious allergic reaction to this drug is rare.||
0341|087|S|However, get medical help right away if you notice any symptoms||
0341|088|S|of a serious allergic reaction, including: rash, itching/swelling||
0341|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0341|090|S|breathing.||
0341|091|S|   This is not a complete list of possible side effects. If you||
0341|092|S|notice other effects not listed above, contact your doctor or||
0341|093|S|pharmacist.||
0341|094|S|   In the US -||
0341|095|S|   Call your doctor for medical advice about side effects. You||
0341|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0341|097|S|www.fda.gov/medwatch.||
0341|098|S|   In Canada - Call your doctor for medical advice about side||
0341|099|S|effects. You may report side effects to Health Canada at||
0341|100|S|1-866-234-2345.||
0341|101|B|||
0341|102|P|PRECAUTIONS:  Before using interferon, tell your doctor or||
0341|103|P|pharmacist if you are allergic to it; or if you have any other||
0341|104|P|allergies. This product may contain inactive ingredients (such as||
0341|105|P|dry natural rubber/latex found in the packaging), which can cause||
0341|106|P|allergic reactions or other problems. Talk to your pharmacist for||
0341|107|P|more details.||
0341|108|P|   Before using this medication, tell your doctor or pharmacist||
0341|109|P|your medical history, especially of: heart disease (such as||
0341|110|P|angina, irregular heartbeat, heart failure), liver disease,||
0341|111|P|seizure disorder, blood cell disorders (such as anemia,||
0341|112|P|neutropenia, thrombocytopenia).||
0341|113|P|   This drug may make you tired or cause mental changes. Alcohol||
0341|114|P|or marijuana (cannabis) can make you more tired or cause mental||
0341|115|P|changes. Do not drive, use machinery, or do anything that needs||
0341|116|P|alertness until you can do it safely. Limit alcoholic beverages.||
0341|117|P|Talk to your doctor if you are using marijuana (cannabis).||
0341|118|P|   Tell your health care professional that you are using this||
0341|119|P|product before having any immunizations/vaccinations.||
0341|120|P|   Before having surgery, tell your doctor or dentist about all||
0341|121|P|the products you use (including prescription drugs,||
0341|122|P|nonprescription drugs, and herbal products).||
0341|123|P|   Children, especially those younger than 1 year, may be at||
0341|124|P|greater risk for effects on the liver while using this drug.||
0341|125|P|   During pregnancy, this medication should be used only when||
0341|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
0341|127|P|   It is unknown if this drug passes into breast milk. Consult||
0341|128|P|your doctor before breastfeeding.||
0341|129|B|||
0341|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0341|131|I|medications work or increase your risk for serious side effects.||
0341|132|I|This document does not contain all possible drug interactions.||
0341|133|I|Keep a list of all the products you use (including||
0341|134|I|prescription/nonprescription drugs and herbal products) and share||
0341|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
0341|136|I|the dosage of any medicines without your doctor's approval.||
0341|137|I|   Some products that may interact with this drug include: drugs||
0341|138|I|that may affect your immune system (such as cancer chemotherapy,||
0341|139|I|prednisone, cyclosporine), hydroxyurea, theophyllines (such as||
0341|140|I|aminophylline, theophylline).||
0341|141|B|||
0341|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0341|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0341|144|O|poison control center right away. US residents can call||
0341|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0341|146|B|||
0341|147|N|NOTES:  Do not share this medication with others.||
0341|148|N|   Lab and/or medical tests (such as complete blood count,||
0341|149|N|kidney/liver function) should be done while you are using this||
0341|150|N|medication. Keep all medical and lab appointments. Consult your||
0341|151|N|doctor for more details.||
0341|152|B|||
0341|153|D|MISSED DOSE:  It is important to get each dose of this medication||
0341|154|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0341|155|D|right away for a new dosing schedule. Do not double the dose to||
0341|156|D|catch up.||
0341|157|B|||
0341|158|R|STORAGE:  Store in the refrigerator. Do not freeze. This||
0341|159|R|medication may also be stored at room temperature if needed. If||
0341|160|R|the medication is stored at room temperature, do not put it back||
0341|161|R|in the refrigerator and discard after 12 hours. Keep all||
0341|162|R|medications away from children and pets.||
0341|163|R|   Do not flush medications down the toilet or pour them into a||
0341|164|R|drain unless instructed to do so. Properly discard this product||
0341|165|R|when it is expired or no longer needed. Consult your pharmacist||
0341|166|R|or local waste disposal company.||
0341|167|B|||
0341|168|A|Information last revised April 2025.||
0341|169|A|Copyright(c) 2025 First Databank, Inc.||
0341|170|B|||
0343|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0343|002|Z|does NOT have all possible information about this product. This||
0343|003|Z|information does not assure that this product is safe, effective,||
0343|004|Z|or appropriate for you. This information is not individual||
0343|005|Z|medical advice and does not substitute for the advice of your||
0343|006|Z|health care professional. Always ask your health care||
0343|007|Z|professional for complete information about this product and your||
0343|008|Z|specific health needs.||
0343|009|B|||
0343|010|T|PARICALCITOL - INJECTION||
0343|011|F|(PAR-i-KAL-si-tol)||
0343|012|B|||
0343|013|C|COMMON BRAND NAME(S): Zemplar||
0343|014|B|||
0343|015|U|USES:  Paricalcitol is a man-made active form of vitamin D, which||
0343|016|U|is needed for building and keeping strong bones. Paricalcitol is||
0343|017|U|used in patients with long-term kidney disease to treat or||
0343|018|U|prevent high levels of a certain natural substance made by the||
0343|019|U|body (parathyroid hormone). Too much parathyroid hormone can||
0343|020|U|cause serious problems such as bone disorders.||
0343|021|U|   Most people get enough vitamin D from exposure to the sun and||
0343|022|U|from fortified food products (such as dairy products, vitamins).||
0343|023|U|Before regular vitamin D can be used by the body, it needs to be||
0343|024|U|changed to the active form by the liver and kidneys. People with||
0343|025|U|kidney disease cannot make enough of the active form of vitamin||
0343|026|U|D. Vitamin D helps control parathyroid hormone and the levels of||
0343|027|U|certain minerals (such as calcium, phosphorus) that are needed||
0343|028|U|for building and keeping strong bones.||
0343|029|B|||
0343|030|H|HOW TO USE:  Read the Patient Information Leaflet if one is||
0343|031|H|available from your pharmacist before you start using||
0343|032|H|paricalcitol. Ask your doctor, nurse, or pharmacist any questions||
0343|033|H|that you may have about this medicine.||
0343|034|H|   This medication is given by injection into a vein during||
0343|035|H|dialysis, usually by a health care professional. It is given as||
0343|036|H|directed by your doctor, usually 3 times a week (every other||
0343|037|H|day). The dosage is based on your condition, weight, lab tests,||
0343|038|H|and response to treatment.||
0343|039|H|   It is very important to follow the diet recommended by your||
0343|040|H|doctor to get the most benefit from this medication and to||
0343|041|H|prevent side effects. Do not take other supplements/vitamins||
0343|042|H|(such as calcium, vitamin D) unless ordered by your doctor.||
0343|043|B|||
0343|044|S|SIDE EFFECTS:  Headache, nausea, chills, or fever may occur. If||
0343|045|S|any of these effects last or get worse, tell your doctor||
0343|046|S|promptly.||
0343|047|S|   Remember that this medication has been prescribed because your||
0343|048|S|doctor has judged that the benefit to you is greater than the||
0343|049|S|risk of side effects. Many people using this medication do not||
0343|050|S|have serious side effects.||
0343|051|S|   Tell your doctor right away if you have any serious side||
0343|052|S|effects, including: constipation, drowsiness, dry mouth,||
0343|053|S|muscle/bone/joint pain, metallic taste in mouth, weakness,||
0343|054|S|vomiting, loss of appetite, unusual weight loss, eye||
0343|055|S|pain/redness/sensitivity to light, severe runny nose,||
0343|056|S|stomach/abdominal pain, dizziness, fast/irregular/pounding||
0343|057|S|heartbeat, swelling hands/ankles/feet, severe mental/mood changes||
0343|058|S|(such as agitation, confusion), easy bleeding/bruising,||
0343|059|S|bloody/tarry stool, vomit that looks like coffee grounds.||
0343|060|S|   A very serious allergic reaction to this drug is rare.||
0343|061|S|However, get medical help right away if you notice any symptoms||
0343|062|S|of a serious allergic reaction, including: rash, itching/swelling||
0343|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0343|064|S|breathing.||
0343|065|S|   This is not a complete list of possible side effects. If you||
0343|066|S|notice other effects not listed above, contact your doctor or||
0343|067|S|pharmacist.||
0343|068|S|   In the US -||
0343|069|S|   Call your doctor for medical advice about side effects. You||
0343|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0343|071|S|www.fda.gov/medwatch.||
0343|072|S|   In Canada - Call your doctor for medical advice about side||
0343|073|S|effects. You may report side effects to Health Canada at||
0343|074|S|1-866-234-2345.||
0343|075|B|||
0343|076|P|PRECAUTIONS:  Before using paricalcitol, tell your doctor or||
0343|077|P|pharmacist if you are allergic to it; or to other vitamin D||
0343|078|P|products; or if you have any other allergies. This product may||
0343|079|P|contain inactive ingredients, which can cause allergic reactions||
0343|080|P|or other problems. Talk to your pharmacist for more details.||
0343|081|P|   Before using this medication, tell your doctor or pharmacist||
0343|082|P|your medical history, especially of: high levels of calcium||
0343|083|P|(hypercalcemia), high levels of vitamin D (hypervitaminosis D),||
0343|084|P|regular use/abuse of alcohol, brain problems (such as seizures,||
0343|085|P|brain injury), heart problems (such as arrhythmias, coronary||
0343|086|P|artery disease), liver disease.||
0343|087|P|   Before having surgery, tell your doctor or dentist about all||
0343|088|P|the products you use (including prescription drugs,||
0343|089|P|nonprescription drugs, and herbal products).||
0343|090|P|   This medication contains alcohol. It may make you dizzy or||
0343|091|P|drowsy. Marijuana (cannabis) can make you more dizzy or drowsy.||
0343|092|P|Do not drive, use machinery, or do anything that needs alertness||
0343|093|P|until you can do it safely. Limit alcoholic beverages. Talk to||
0343|094|P|your doctor if you are using marijuana (cannabis).||
0343|095|P|   During pregnancy, this medication should be used only when||
0343|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
0343|097|P|   It is unknown if this medication passes into breast milk.||
0343|098|P|Consult your doctor before breastfeeding.||
0343|099|B|||
0343|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0343|101|I|medications work or increase your risk for serious side effects.||
0343|102|I|This document does not contain all possible drug interactions.||
0343|103|I|Keep a list of all the products you use (including||
0343|104|I|prescription/nonprescription drugs and herbal products) and share||
0343|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
0343|106|I|the dosage of any medicines without your doctor's approval.||
0343|107|I|   Some products that may interact with this drug include:||
0343|108|I|burosumab, products that contain aluminum/magnesium (such as||
0343|109|I|certain antacids, phosphate binders), corticosteroids (such as||
0343|110|I|prednisone), calcium supplements, other products that contain||
0343|111|I|vitamin D or phosphate (such as ergocalciferol, sodium||
0343|112|I|phosphate).||
0343|113|I|   Tell your doctor or pharmacist if you are taking other||
0343|114|I|products that cause drowsiness such as opioid pain or cough||
0343|115|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0343|116|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0343|117|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0343|118|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0343|119|I|diphenhydramine).||
0343|120|I|   Check the labels on all your medicines (such as allergy or||
0343|121|I|cough-and-cold products) because they may contain ingredients||
0343|122|I|that cause drowsiness. Ask your pharmacist about using those||
0343|123|I|products safely.||
0343|124|I|   Check the labels on all your prescription and||
0343|125|I|nonprescription/herbal products (such as antacids, vitamins)||
0343|126|I|because they may contain calcium, phosphate, or vitamin D. Ask||
0343|127|I|your pharmacist about using those products safely.||
0343|128|B|||
0343|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0343|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0343|131|O|poison control center right away. US residents can call||
0343|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0343|133|B|||
0343|134|N|NOTES:  Lab and/or medical tests (such as blood levels of||
0343|135|N|aluminum, calcium, magnesium, phosphorus, and parathyroid||
0343|136|N|hormone) should be done while you are using this medication. Keep||
0343|137|N|all medical and lab appointments. Consult your doctor for more||
0343|138|N|details.||
0343|139|B|||
0343|140|D|MISSED DOSE:  It is important to get each dose of this medication||
0343|141|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0343|142|D|right away for a new dosing schedule.||
0343|143|B|||
0343|144|R|STORAGE:  Not applicable. This medication is given in a clinic||
0343|145|R|and will not be stored at home.||
0343|146|B|||
0343|147|A|Information last revised May 2024.||
0343|148|A|Copyright(c) 2025 First Databank, Inc.||
0343|149|B|||
0345|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0345|002|Z|does NOT have all possible information about this product. This||
0345|003|Z|information does not assure that this product is safe, effective,||
0345|004|Z|or appropriate for you. This information is not individual||
0345|005|Z|medical advice and does not substitute for the advice of your||
0345|006|Z|health care professional. Always ask your health care||
0345|007|Z|professional for complete information about this product and your||
0345|008|Z|specific health needs.||
0345|009|B|||
0345|010|T|ANAKINRA - INJECTION||
0345|011|F|(an-a-KIN-ra)||
0345|012|B|||
0345|013|C|COMMON BRAND NAME(S): Kineret||
0345|014|B|||
0345|015|U|USES:  Anakinra is used to treat rheumatoid arthritis. It helps||
0345|016|U|to slow joint damage and reduces the joint pain/swelling so that||
0345|017|U|you can move better. It is also used to treat a certain group of||
0345|018|U|inherited disorders called cryopyrin-associated periodic||
0345|019|U|syndromes (CAPS), including neonatal-onset multisystem||
0345|020|U|inflammatory disease (NOMID). It helps to improve symptoms of||
0345|021|U|NOMID such as fever, rash, joint pain, vomiting, and headache.||
0345|022|U|Anakinra may also be used to treat another condition called||
0345|023|U|Deficiency of Interleukin-1 Receptor Antagonist (DIRA), a||
0345|024|U|condition where your body does not produce the natural protein||
0345|025|U|interleukin-1 receptor antagonist.||
0345|026|U|   Anakinra is a man-made form of a natural protein||
0345|027|U|(interleukin-1 receptor antagonist) made by the body. It helps to||
0345|028|U|block the effects of another protein (interleukin-1) which can||
0345|029|U|cause symptoms such as joint pain/swelling/stiffness.||
0345|030|U|   The FDA is allowing the emergency use of anakinra to treat||
0345|031|U|coronavirus disease (COVID-19) in hospitalized patients with||
0345|032|U|pneumonia and who also need supplemental oxygen. If anakinra is||
0345|033|U|used to treat coronavirus disease, more information about the||
0345|034|U|drug is available from the patient information sheet provided by||
0345|035|U|your health care professional.||
0345|036|B|||
0345|037|V|OTHER USES:  This section contains uses of this drug that are not||
0345|038|V|listed in the approved professional labeling for the drug but||
0345|039|V|that may be prescribed by your health care professional. Use this||
0345|040|V|drug for a condition that is listed in this section only if it||
0345|041|V|has been so prescribed by your health care professional.||
0345|042|V|   This drug may also be used for a certain type of rheumatoid||
0345|043|V|arthritis in children (systemic juvenile idiopathic arthritis) or||
0345|044|V|gout.||
0345|045|B|||
0345|046|H|HOW TO USE:  Read the Patient Information Leaflet and||
0345|047|H|Instructions for Use if available from your pharmacist before you||
0345|048|H|start using anakinra and each time you get a refill. Ask your||
0345|049|H|health care professional how to prepare and use this medication.||
0345|050|H|If you have any questions, consult your doctor or pharmacist.||
0345|051|H|   Inject this medication under the skin as directed by your||
0345|052|H|doctor, usually once a day. The injection is given in the upper||
0345|053|H|arms, thighs, buttocks, or abdomen (except for a 2-inch area||
0345|054|H|around your belly button). The dosage is based on your medical||
0345|055|H|condition, weight, and response to treatment.||
0345|056|H|   Take the medication out of the refrigerator 30 minutes before||
0345|057|H|you inject it to allow it to reach room temperature. Do not shake||
0345|058|H|the medication. Before using, check this product for particles or||
0345|059|H|discoloration. If either is present, do not use the liquid.||
0345|060|H|Before injecting each dose, clean the skin you are going to||
0345|061|H|inject into (the injection site) with rubbing alcohol. Change the||
0345|062|H|injection site each time to lessen injury under the skin. Do not||
0345|063|H|inject into skin that is bruised, red, scaly, pitted, hard,||
0345|064|H|thickened, lumpy, damaged, tender, or into scars or stretch||
0345|065|H|marks. To lessen bruising, do not rub the injection site after a||
0345|066|H|shot. Learn how to store and discard medical supplies safely.||
0345|067|H|   Use this medication regularly to get the most benefit from it.||
0345|068|H|To help you remember, use it at the same time each day.||
0345|069|H|   Tell your doctor if your condition does not get better or if||
0345|070|H|it gets worse.||
0345|071|B|||
0345|072|S|SIDE EFFECTS:  Redness, bruising, swelling, and pain at the||
0345|073|S|injection site may occur. These skin reactions are usually mild||
0345|074|S|and may last 2 to 4 weeks. If any of these effects last or get||
0345|075|S|worse, tell your doctor or pharmacist promptly.||
0345|076|S|   Remember that this medication has been prescribed because your||
0345|077|S|doctor has judged that the benefit to you is greater than the||
0345|078|S|risk of side effects. Many people using this medication do not||
0345|079|S|have serious side effects.||
0345|080|S|   Tell your doctor right away if you have any serious side||
0345|081|S|effects, including:  a hard lump at the injection site.||
0345|082|S|   This medication may lower your ability to fight infections.||
0345|083|S|This may make you more likely to get a serious infection or make||
0345|084|S|any infection you have worse. Get medical help right away if you||
0345|085|S|have any signs of infection (such as sore throat that doesn't go||
0345|086|S|away, fever, swollen lymph nodes, chills).||
0345|087|S|   A very serious allergic reaction to this drug is rare.||
0345|088|S|However, get medical help right away if you notice any symptoms||
0345|089|S|of a serious allergic reaction, including: rash, itching/swelling||
0345|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0345|091|S|breathing.||
0345|092|S|   This is not a complete list of possible side effects. If you||
0345|093|S|notice other effects not listed above, contact your doctor or||
0345|094|S|pharmacist.||
0345|095|S|   In the US -||
0345|096|S|   Call your doctor for medical advice about side effects. You||
0345|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0345|098|S|www.fda.gov/medwatch.||
0345|099|S|   In Canada - Call your doctor for medical advice about side||
0345|100|S|effects. You may report side effects to Health Canada at||
0345|101|S|1-866-234-2345.||
0345|102|B|||
0345|103|P|PRECAUTIONS:  Before using anakinra, tell your doctor or||
0345|104|P|pharmacist if you are allergic to it; or to proteins made from a||
0345|105|P|certain bacteria (E. coli); or to latex; or if you have any other||
0345|106|P|allergies. This product may contain inactive ingredients, which||
0345|107|P|can cause allergic reactions or other problems. Talk to your||
0345|108|P|pharmacist for more details.||
0345|109|P|   Before using this medication, tell your doctor or pharmacist||
0345|110|P|your medical history, especially of: current/past/returning||
0345|111|P|infections (such as tuberculosis), immune system problems (such||
0345|112|P|as HIV disease), kidney disease, asthma.||
0345|113|P|   Anakinra can make you more likely to get infections or may||
0345|114|P|make current infections worse. Stay away from anyone who has an||
0345|115|P|infection that may easily spread (such as chickenpox, COVID-19,||
0345|116|P|measles, flu). Talk to your doctor if you have been exposed to an||
0345|117|P|infection or for more details.||
0345|118|P|   Tell your health care professional that you are using anakinra||
0345|119|P|before having any immunizations/vaccinations. Avoid contact with||
0345|120|P|people who have recently received live vaccines (such as flu||
0345|121|P|vaccine inhaled through the nose).||
0345|122|P|   Older adults may be at greater risk for infections while using||
0345|123|P|this drug.||
0345|124|P|   During pregnancy, this medication should be used only when||
0345|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
0345|126|P|   It is unknown if this medication passes into breast milk.||
0345|127|P|Consult your doctor before breastfeeding.||
0345|128|B|||
0345|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0345|130|I|medications work or increase your risk for serious side effects.||
0345|131|I|This document does not contain all possible drug interactions.||
0345|132|I|Keep a list of all the products you use (including||
0345|133|I|prescription/nonprescription drugs and herbal products) and share||
0345|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
0345|135|I|the dosage of any medicines without your doctor's approval.||
0345|136|I|   Some products that may interact with this drug include:||
0345|137|I|abatacept, TNF blockers (such as adalimumab, certolizumab,||
0345|138|I|etanercept, infliximab).||
0345|139|B|||
0345|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0345|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0345|142|O|poison control center right away. US residents can call||
0345|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0345|144|B|||
0345|145|N|NOTES:  Do not share this medication with others.||
0345|146|N|   Lab and/or medical tests (such as absolute neutrophil count)||
0345|147|N|should be done while you are using this medication. Keep all||
0345|148|N|medical and lab appointments. Consult your doctor for more||
0345|149|N|details.||
0345|150|B|||
0345|151|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0345|152|D|If it is near the time of the next dose, skip the missed dose.||
0345|153|D|Use your next dose at the regular time. Do not double the dose to||
0345|154|D|catch up.||
0345|155|B|||
0345|156|R|STORAGE:  Store in the refrigerator away from light. Do not||
0345|157|R|freeze. Keep all medications away from children and pets.||
0345|158|R|   Do not flush medications down the toilet or pour them into a||
0345|159|R|drain unless instructed to do so. Properly discard this product||
0345|160|R|when it is expired or no longer needed. Consult your pharmacist||
0345|161|R|or local waste disposal company.||
0345|162|B|||
0345|163|A|Information last revised October 2025.||
0345|164|A|Copyright(c) 2025 First Databank, Inc.||
0345|165|B|||
0347|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0347|002|Z|does NOT have all possible information about this product. This||
0347|003|Z|information does not assure that this product is safe, effective,||
0347|004|Z|or appropriate for you. This information is not individual||
0347|005|Z|medical advice and does not substitute for the advice of your||
0347|006|Z|health care professional. Always ask your health care||
0347|007|Z|professional for complete information about this product and your||
0347|008|Z|specific health needs.||
0347|009|B|||
0347|010|T|FROVATRIPTAN - ORAL||
0347|011|F|(FROE-va-TRIP-tan)||
0347|012|B|||
0347|013|C|COMMON BRAND NAME(S): Frova||
0347|014|B|||
0347|015|U|USES:  Frovatriptan is used to treat migraines. It helps to||
0347|016|U|relieve headache, pain, and other migraine symptoms (including||
0347|017|U|nausea, vomiting, sensitivity to light/sound). Prompt treatment||
0347|018|U|helps you return to your normal routine and may decrease your||
0347|019|U|need for other pain medications. Frovatriptan belongs to a class||
0347|020|U|of drugs known as triptans. It affects a certain natural||
0347|021|U|substance (serotonin) that causes narrowing of blood vessels in||
0347|022|U|the brain. It may also relieve pain by affecting certain nerves||
0347|023|U|in the brain.||
0347|024|U|   Frovatriptan does not prevent future migraines or lessen how||
0347|025|U|often you get migraine attacks.||
0347|026|B|||
0347|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0347|028|H|from your pharmacist before you start taking frovatriptan and||
0347|029|H|each time you get a refill. If you have any questions, ask your||
0347|030|H|doctor or pharmacist.||
0347|031|H|   Take this medication by mouth as directed by your doctor, at||
0347|032|H|the first sign of a migraine. It may be taken with or without||
0347|033|H|food, but may work faster when it is taken on an empty stomach.||
0347|034|H|The dosage is based on your medical condition and response to||
0347|035|H|treatment. If there is no improvement in your symptoms, do not||
0347|036|H|take more doses of this medication before talking to your doctor.||
0347|037|H|   If your symptoms are only partly relieved or if your headache||
0347|038|H|comes back, the U.S. manufacturer recommends that you may take||
0347|039|H|another dose after 2 hours, up to a maximum of 3 doses (7.5||
0347|040|H|milligrams) in a 24-hour period. The Canadian manufacturer||
0347|041|H|recommends that you may take another dose after 4 hours, up to a||
0347|042|H|maximum of 2 doses (5 milligrams) in a 24-hour period. Carefully||
0347|043|H|follow your doctor's directions for using this medication.||
0347|044|H|   If you have a higher risk for heart problems (see||
0347|045|H|Precautions), your doctor may perform a heart exam before you||
0347|046|H|start taking frovatriptan. He/she may also direct you to take||
0347|047|H|your first dose of this medication in the office/clinic to||
0347|048|H|monitor for serious side effects (such as chest pain). Talk to||
0347|049|H|your doctor for details.||
0347|050|H|   If you are using drugs for migraine attacks on 10 or more days||
0347|051|H|each month, the drugs may actually make your headaches worse||
0347|052|H|(medication overuse headache). Do not use medications more often||
0347|053|H|or for longer than directed. Tell your doctor if you need to use||
0347|054|H|this medication more often, or if the medication is not working||
0347|055|H|as well, or if your headaches get worse.||
0347|056|B|||
0347|057|S|SIDE EFFECTS:  Flushing, feelings of||
0347|058|S|tingling/numbness/prickling/heat, tiredness, dry mouth, or||
0347|059|S|dizziness may occur. If any of these effects last or get worse,||
0347|060|S|tell your doctor or pharmacist promptly.||
0347|061|S|   Remember that this medication has been prescribed because your||
0347|062|S|doctor has judged that the benefit to you is greater than the||
0347|063|S|risk of side effects. Many people using this medication do not||
0347|064|S|have serious side effects.||
0347|065|S|   This medication may raise your blood pressure. Check your||
0347|066|S|blood pressure regularly and tell your doctor if the results are||
0347|067|S|high.||
0347|068|S|   Tell your doctor right away if you have any serious side||
0347|069|S|effects, including: blue fingers/toes/nails, cold hands/feet,||
0347|070|S|hearing changes, mental/mood changes.||
0347|071|S|   Frovatriptan can commonly cause chest/jaw/neck tightness,||
0347|072|S|pain, or pressure that is usually not serious. However, these||
0347|073|S|side effects are like symptoms of a heart attack, which may||
0347|074|S|include chest/jaw/left arm pain, shortness of breath, or unusual||
0347|075|S|sweating. Get medical help right away if these or other serious||
0347|076|S|side effects occur, including: fast/irregular heartbeat,||
0347|077|S|fainting, severe stomach/abdominal pain, bloody diarrhea, signs||
0347|078|S|of a stroke (such as weakness on one side of the body, trouble||
0347|079|S|speaking, sudden vision changes, confusion).||
0347|080|S|   This medication may increase serotonin and rarely cause a very||
0347|081|S|serious condition called serotonin syndrome/toxicity. The risk||
0347|082|S|increases if you are also taking other drugs that increase||
0347|083|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0347|084|S|take (see Drug Interactions section). Get medical help right away||
0347|085|S|if you develop some of the following symptoms: fast heartbeat,||
0347|086|S|hallucinations, loss of coordination, severe dizziness, severe||
0347|087|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0347|088|S|unusual agitation/restlessness.||
0347|089|S|   A very serious allergic reaction to this drug is rare.||
0347|090|S|However, get medical help right away if you notice any symptoms||
0347|091|S|of a serious allergic reaction, including: rash, itching/swelling||
0347|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0347|093|S|breathing.||
0347|094|S|   This is not a complete list of possible side effects. If you||
0347|095|S|notice other effects not listed above, contact your doctor or||
0347|096|S|pharmacist.||
0347|097|S|   In the US -||
0347|098|S|   Call your doctor for medical advice about side effects. You||
0347|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0347|100|S|www.fda.gov/medwatch.||
0347|101|S|   In Canada - Call your doctor for medical advice about side||
0347|102|S|effects. You may report side effects to Health Canada at||
0347|103|S|1-866-234-2345.||
0347|104|B|||
0347|105|P|PRECAUTIONS:  Before taking frovatriptan, tell your doctor or||
0347|106|P|pharmacist if you are allergic to it; or if you have any other||
0347|107|P|allergies. This product may contain inactive ingredients, which||
0347|108|P|can cause allergic reactions or other problems. Talk to your||
0347|109|P|pharmacist for more details.||
0347|110|P|   Before using this medication, tell your doctor or pharmacist||
0347|111|P|your medical history, especially of: blood circulation problems||
0347|112|P|(for example, in your legs, arms/hands, or stomach), certain||
0347|113|P|types of headaches (hemiplegic or basilar migraine), heart||
0347|114|P|problems (such as chest pain, irregular heartbeat, previous heart||
0347|115|P|attack), liver disease, seizure, stroke or "mini-stroke"||
0347|116|P|(transient ischemic attack).||
0347|117|P|   Certain conditions can increase your risk for heart problems.||
0347|118|P|Tell your doctor if you have any of these conditions, including:||
0347|119|P|high blood pressure, high cholesterol, diabetes, family history||
0347|120|P|of heart disease, overweight, smoker, postmenopausal (women), age||
0347|121|P|more than 40 years (men).||
0347|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0347|123|P|can make you more dizzy. Do not drive, use machinery, or do||
0347|124|P|anything that needs alertness until you can do it safely. Limit||
0347|125|P|alcoholic beverages. Talk to your doctor if you are using||
0347|126|P|marijuana (cannabis).||
0347|127|P|   Before having surgery, tell your doctor or dentist about all||
0347|128|P|the products you use (including prescription drugs,||
0347|129|P|nonprescription drugs, and herbal products).||
0347|130|P|   The risk of heart disease and high blood pressure increases||
0347|131|P|with age. Older adults may be more sensitive to the side effects||
0347|132|P|of this drug, especially increased blood pressure and heart||
0347|133|P|problems.||
0347|134|P|   During pregnancy, this medication should be used only when||
0347|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
0347|136|P|   It is unknown if this drug passes into breast milk. Consult||
0347|137|P|your doctor before breastfeeding.||
0347|138|B|||
0347|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0347|140|I|medications work or increase your risk for serious side effects.||
0347|141|I|This document does not contain all possible drug interactions.||
0347|142|I|Keep a list of all the products you use (including||
0347|143|I|prescription/nonprescription drugs and herbal products) and share||
0347|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
0347|145|I|the dosage of any medicines without your doctor's approval.||
0347|146|I|   The risk of serotonin syndrome/toxicity increases if you are||
0347|147|I|also taking other drugs that increase serotonin. Examples include||
0347|148|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0347|149|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0347|150|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0347|151|I|serotonin syndrome/toxicity may be more likely when you start or||
0347|152|I|increase the dose of these drugs.||
0347|153|I|   If you also take any ergotamine medication (such as||
0347|154|I|dihydroergotamine) or other "triptan" drugs (such as||
0347|155|I|zolmitriptan, rizatriptan), you will need to separate your||
0347|156|I|frovatriptan dose at least 24 hours apart from your dose of these||
0347|157|I|other medications to lessen the chance of serious side effects.||
0347|158|B|||
0347|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0347|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0347|161|O|poison control center right away. US residents can call||
0347|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0347|163|B|||
0347|164|N|NOTES:  Do not share this medication with others.||
0347|165|N|   Certain foods, beverages, or food additives (such as red wine,||
0347|166|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
0347|167|N|patterns such as irregular eating/sleeping habits or stress may||
0347|168|N|bring on a migraine headache. Avoiding these "triggers" may help||
0347|169|N|lessen migraine attacks. Consult your doctor for more details.||
0347|170|N|   Lab and/or medical tests (such as blood pressure) may be done||
0347|171|N|while you are taking this medication. Keep all medical and lab||
0347|172|N|appointments. Consult your doctor for more details.||
0347|173|B|||
0347|174|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
0347|175|B|||
0347|176|R|STORAGE:  Store at room temperature away from light and moisture.||
0347|177|R|Do not store in the bathroom. Keep all medications away from||
0347|178|R|children and pets.||
0347|179|R|   Do not flush medications down the toilet or pour them into a||
0347|180|R|drain unless instructed to do so. Properly discard this product||
0347|181|R|when it is expired or no longer needed. Consult your pharmacist||
0347|182|R|or local waste disposal company.||
0347|183|B|||
0347|184|A|Information last revised May 2024.||
0347|185|A|Copyright(c) 2025 First Databank, Inc.||
0347|186|B|||
0348|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0348|002|Z|does NOT have all possible information about this product. This||
0348|003|Z|information does not assure that this product is safe, effective,||
0348|004|Z|or appropriate for you. This information is not individual||
0348|005|Z|medical advice and does not substitute for the advice of your||
0348|006|Z|health care professional. Always ask your health care||
0348|007|Z|professional for complete information about this product and your||
0348|008|Z|specific health needs.||
0348|009|B|||
0348|010|T|BOSENTAN - ORAL||
0348|011|F|(boe-SEN-tan)||
0348|012|B|||
0348|013|C|COMMON BRAND NAME(S): Tracleer||
0348|014|B|||
0348|015|W|WARNING:  Bosentan may rarely cause serious (possibly fatal)||
0348|016|W|liver damage. Rarely, liver problems have happened in people||
0348|017|W|after stopping treatment with bosentan. Your doctor will perform||
0348|018|W|liver function tests before you start treatment and once a month||
0348|019|W|during treatment. Tell your doctor right away if you notice||
0348|020|W|nausea/vomiting that doesn't stop, dark urine, loss of appetite,||
0348|021|W|stomach/abdominal pain, or yellowing eyes/skin.||
0348|022|W|   This medication must not be used during pregnancy. It may harm||
0348|023|W|an unborn baby. It is important to prevent pregnancy while taking||
0348|024|W|this medication and for 1 month after treatment. Female patients||
0348|025|W|must use reliable birth control during treatment and for 1 month||
0348|026|W|after the last dose. Ask your doctor which forms of birth control||
0348|027|W|to use while taking this medication. Female patients must take a||
0348|028|W|pregnancy test before starting treatment. If you become pregnant||
0348|029|W|or think you may be pregnant, tell your doctor right away.||
0348|030|W|   To receive bosentan in the United States, you must understand,||
0348|031|W|agree to, and carefully follow the requirements of the REMS||
0348|032|W|Program for this medication. If you live in Canada or any other||
0348|033|W|country, consult your doctor and pharmacist for your country's||
0348|034|W|regulations.||
0348|035|B|||
0348|036|U|USES:  Bosentan is used to treat high blood pressure in the lungs||
0348|037|U|(pulmonary arterial hypertension). This condition is thought to||
0348|038|U|be caused by increased levels of a certain natural substance||
0348|039|U|(endothelin-1). This medication blocks the effects of||
0348|040|U|endothelin-1, thereby helping to decrease the blood pressure in||
0348|041|U|the lungs, slow the worsening of symptoms from the disease, and||
0348|042|U|improve your ability to exercise.||
0348|043|B|||
0348|044|H|HOW TO USE:  Read the Medication Guide provided by your||
0348|045|H|pharmacist before you start using bosentan and each time you get||
0348|046|H|a refill. If you have any questions, consult your doctor or||
0348|047|H|pharmacist.||
0348|048|H|   Take this medication by mouth with or without food as directed||
0348|049|H|by your doctor, usually twice daily (in the morning and evening).||
0348|050|H|   The dosage is based on your medical condition, weight,||
0348|051|H|response to treatment, and other medications you may be taking.||
0348|052|H|Be sure to tell your doctor and pharmacist about all the products||
0348|053|H|you use (including prescription drugs, nonprescription drugs, and||
0348|054|H|herbal products). Your doctor may start you on a lower dose of||
0348|055|H|this medication and then increase the dose after several weeks.||
0348|056|H|   Use this medication regularly to get the most benefit from it.||
0348|057|H|To help you remember, take it at the same times each day.||
0348|058|H|   Do not stop taking this medication without consulting your||
0348|059|H|doctor. Some conditions may become worse when the drug is||
0348|060|H|suddenly stopped. Your dose may need to be gradually decreased.||
0348|061|H|   Since this drug can be absorbed through the skin and lungs and||
0348|062|H|may harm an unborn baby, women who are pregnant or who may become||
0348|063|H|pregnant should not handle this medication or breathe the dust||
0348|064|H|from the tablets. Do not crush the tablets because doing so will||
0348|065|H|increase exposure to the dust.||
0348|066|H|   Tell your doctor if your condition lasts or gets worse.||
0348|067|B|||
0348|068|S|SIDE EFFECTS:  See also Warning section.||
0348|069|S|   Dizziness, flushing, stuffy nose, or joint pain may occur. If||
0348|070|S|any of these effects last or get worse, tell your doctor or||
0348|071|S|pharmacist promptly.||
0348|072|S|   Remember that this medication has been prescribed because your||
0348|073|S|doctor has judged that the benefit to you is greater than the||
0348|074|S|risk of side effects. Many people using this medication do not||
0348|075|S|have serious side effects.||
0348|076|S|   Tell your doctor right away if you have any serious side||
0348|077|S|effects, including: fast/pounding heartbeat, unusual tiredness,||
0348|078|S|swelling ankles/feet, unusual/sudden weight gain, fainting,||
0348|079|S|shortness of breath, coughing up blood.||
0348|080|S|   In men, this medication can decrease sperm production, which||
0348|081|S|may affect the ability to father a child. Talk to your doctor for||
0348|082|S|more details.||
0348|083|S|   A very serious allergic reaction to this drug is rare.||
0348|084|S|However, get medical help right away if you notice any symptoms||
0348|085|S|of a serious allergic reaction, including: fever, swollen lymph||
0348|086|S|nodes, rash, itching/swelling (especially of the||
0348|087|S|face/tongue/throat), severe dizziness, trouble breathing.||
0348|088|S|   This is not a complete list of possible side effects. If you||
0348|089|S|notice other effects not listed above, contact your doctor or||
0348|090|S|pharmacist.||
0348|091|S|   In the US -||
0348|092|S|   Call your doctor for medical advice about side effects. You||
0348|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0348|094|S|www.fda.gov/medwatch.||
0348|095|S|   In Canada - Call your doctor for medical advice about side||
0348|096|S|effects. You may report side effects to Health Canada at||
0348|097|S|1-866-234-2345.||
0348|098|B|||
0348|099|P|PRECAUTIONS:  Before taking bosentan, tell your doctor or||
0348|100|P|pharmacist if you are allergic to it; or if you have any other||
0348|101|P|allergies. This product may contain inactive ingredients, which||
0348|102|P|can cause allergic reactions or other problems. Talk to your||
0348|103|P|pharmacist for more details.||
0348|104|P|   Before using this medication, tell your doctor or pharmacist||
0348|105|P|your medical history, especially of: liver disease, anemia.||
0348|106|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0348|107|P|can make you more dizzy. Do not drive, use machinery, or do||
0348|108|P|anything that needs alertness until you can do it safely. Avoid||
0348|109|P|alcoholic beverages. Talk to your doctor if you are using||
0348|110|P|marijuana (cannabis). Alcohol may also increase the risk of||
0348|111|P|serious liver problems.||
0348|112|P|   Before having surgery, tell your doctor or dentist about all||
0348|113|P|the products you use (including prescription drugs,||
0348|114|P|nonprescription drugs, and herbal products).||
0348|115|P|   Since this drug can be absorbed through the skin and lungs and||
0348|116|P|may harm an unborn baby, women who are pregnant or who may become||
0348|117|P|pregnant should not handle this medication or breathe the dust||
0348|118|P|from the tablets.||
0348|119|P|   This medication must not be used during pregnancy. It may harm||
0348|120|P|an unborn baby. Discuss the use of reliable forms of birth||
0348|121|P|control during treatment and for 1 month after the last dose. If||
0348|122|P|you become pregnant or think you may be pregnant, tell your||
0348|123|P|doctor right away. See also Warning section.||
0348|124|P|   This medication passes into breast milk. Consult your doctor||
0348|125|P|before breastfeeding.||
0348|126|B|||
0348|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0348|128|I|medications work or increase your risk for serious side effects.||
0348|129|I|This document does not contain all possible drug interactions.||
0348|130|I|Keep a list of all the products you use (including||
0348|131|I|prescription/nonprescription drugs and herbal products) and share||
0348|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
0348|133|I|the dosage of any medicines without your doctor's approval.||
0348|134|I|   A product that may interact with this drug is: sparsentan.||
0348|135|I|   Other medications can affect the removal of bosentan from your||
0348|136|I|body, which may affect how bosentan works. Examples include||
0348|137|I|cyclosporine, HIV protease inhibitors (such as atazanavir), among||
0348|138|I|others.||
0348|139|I|   This drug can speed up the removal of other drugs from your||
0348|140|I|body, which may affect how they work. Examples of affected drugs||
0348|141|I|include daridorexant, elacestrant, glyburide, mavacamten,||
0348|142|I|quizartinib, revumenib, among others.||
0348|143|I|   This medication may decrease the effectiveness of hormonal||
0348|144|I|birth control such as pills, patch, or ring. This could cause||
0348|145|I|pregnancy. Discuss with your doctor or pharmacist about using a||
0348|146|I|reliable backup birth control method while using this medication.||
0348|147|I|Also tell your doctor if you have any new spotting or||
0348|148|I|breakthrough bleeding, because these may be signs that your birth||
0348|149|I|control is not working well.||
0348|150|B|||
0348|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0348|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0348|153|O|poison control center right away. US residents can call||
0348|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0348|155|O|Symptoms of overdose may include: severe headache, severe||
0348|156|O|dizziness, nausea, vomiting.||
0348|157|B|||
0348|158|N|NOTES:  Do not share this medication with others.||
0348|159|N|   Lab and/or medical tests (such as liver function, pregnancy||
0348|160|N|tests, hemoglobin, hematocrit) should be done before you start||
0348|161|N|taking this medication and while you are taking it. Keep all||
0348|162|N|medical and lab appointments. Consult your doctor for more||
0348|163|N|details.||
0348|164|B|||
0348|165|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0348|166|D|If it is near the time of the next dose, skip the missed dose.||
0348|167|D|Use your next dose at the regular time. Do not double the dose to||
0348|168|D|catch up.||
0348|169|B|||
0348|170|R|STORAGE:  Store at room temperature away from light and moisture.||
0348|171|R|Do not store in the bathroom. Keep all medications away from||
0348|172|R|children and pets.||
0348|173|R|   Do not flush medications down the toilet or pour them into a||
0348|174|R|drain unless instructed to do so. Properly discard this product||
0348|175|R|when it is expired or no longer needed. Consult your pharmacist||
0348|176|R|or local waste disposal company.||
0348|177|B|||
0348|178|A|Information last revised November 2025.||
0348|179|A|Copyright(c) 2025 First Databank, Inc.||
0348|180|B|||
0349|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0349|002|Z|does NOT have all possible information about this product. This||
0349|003|Z|information does not assure that this product is safe, effective,||
0349|004|Z|or appropriate for you. This information is not individual||
0349|005|Z|medical advice and does not substitute for the advice of your||
0349|006|Z|health care professional. Always ask your health care||
0349|007|Z|professional for complete information about this product and your||
0349|008|Z|specific health needs.||
0349|009|B|||
0349|010|T|VERTEPORFIN - INJECTION||
0349|011|F|(VER-te-POR-fin)||
0349|012|B|||
0349|013|C|COMMON BRAND NAME(S): Visudyne||
0349|014|B|||
0349|015|U|USES:  Verteporfin is used along with laser light treatment to||
0349|016|U|treat certain serious eye conditions (such as macular||
0349|017|U|degeneration, pathologic myopia, ocular histoplasmosis). It is||
0349|018|U|used to help prevent decreased vision and blindness. After you||
0349|019|U|have received the injection of verteporfin, your doctor will use||
0349|020|U|laser light treatment on the affected eye(s). The laser light||
0349|021|U|will change the drug to a form that works by damaging only those||
0349|022|U|cells that cause the serious eye problem.||
0349|023|B|||
0349|024|H|HOW TO USE:  This medication is given by injection into a vein by||
0349|025|H|a health care professional as directed by your doctor. The dosage||
0349|026|H|is based on your body size and response to treatment.||
0349|027|H|   Your doctor will treat your affected eye with laser light||
0349|028|H|about 15 minutes after you receive this medication. If you have||
0349|029|H|any questions about the treatment, consult your doctor.||
0349|030|H|   Wear a wristband for 5 days after receiving this drug to||
0349|031|H|notify other health care professionals that you have received||
0349|032|H|this drug and to remind you to avoid bright lights (such as||
0349|033|H|halogen lights) and direct sunlight. However, do not stay in||
0349|034|H|totally dark areas after treatment. You should expose your skin||
0349|035|H|to regular indoor/indirect light because doing so will help stop||
0349|036|H|any drug in your skin from causing damage to skin cells. If any||
0349|037|H|of the information is unclear, consult your doctor. (See also||
0349|038|H|Precautions section.)||
0349|039|B|||
0349|040|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
0349|041|S|irritation, swelling), headache, tiredness, or blurred vision may||
0349|042|S|occur. If any of these effects last or get worse, tell your||
0349|043|S|doctor promptly.||
0349|044|S|   Remember that this medication has been prescribed because your||
0349|045|S|doctor has judged that the benefit to you is greater than the||
0349|046|S|risk of side effects. Many people using this medication do not||
0349|047|S|have serious side effects.||
0349|048|S|   Tell your doctor right away if you have any serious side||
0349|049|S|effects, including: chest pain, fainting, eye pain, sudden change||
0349|050|S|in vision, severe pain/swelling at injection site.||
0349|051|S|   A very serious allergic reaction to this drug is rare.||
0349|052|S|However, get medical help right away if you notice any symptoms||
0349|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0349|054|S|(especially of the face/tongue/throat), flushing, severe||
0349|055|S|dizziness, trouble breathing.||
0349|056|S|   This is not a complete list of possible side effects. If you||
0349|057|S|notice other effects not listed above, contact your doctor or||
0349|058|S|pharmacist.||
0349|059|S|   In the US -||
0349|060|S|   Call your doctor for medical advice about side effects. You||
0349|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0349|062|S|www.fda.gov/medwatch.||
0349|063|S|   In Canada - Call your doctor for medical advice about side||
0349|064|S|effects. You may report side effects to Health Canada at||
0349|065|S|1-866-234-2345.||
0349|066|B|||
0349|067|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0349|068|P|pharmacist if you are allergic to verteporfin; or if you have any||
0349|069|P|other allergies. This product may contain inactive ingredients,||
0349|070|P|which can cause allergic reactions or other problems. Talk to||
0349|071|P|your pharmacist for more details.||
0349|072|P|   Before using this medication, tell your doctor or pharmacist||
0349|073|P|your medical history, especially of: a certain metabolic disorder||
0349|074|P|(porphyria), liver disease.||
0349|075|P|   This medication will make you more sensitive to the sun and to||
0349|076|P|bright indoor lights. Avoid sun exposure, halogen lights,||
0349|077|P|high-powered indoor lighting used in operating rooms/dental||
0349|078|P|offices, tanning booths, and sunlamps for at least 5 days after||
0349|079|P|receiving this medication. Wear protective clothing and dark||
0349|080|P|sunglasses when outdoors. Sunscreens will not provide protection.||
0349|081|P|   This drug may cause blurred vision. Do not drive, use||
0349|082|P|machinery, or do anything that needs clear vision until you can||
0349|083|P|do it safely.||
0349|084|P|   Before having surgery, tell your doctor or dentist about all||
0349|085|P|the products you use (including prescription drugs,||
0349|086|P|nonprescription drugs, and herbal products). It is recommended||
0349|087|P|that you avoid surgery/dental procedures for at least 5 days||
0349|088|P|after receiving a dose of verteporfin.||
0349|089|P|   During pregnancy, this medication should be used only when||
0349|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
0349|091|P|   This medication passes into breast milk and may have||
0349|092|P|undesirable effects on a nursing infant. Breastfeeding is not||
0349|093|P|recommended while using this medication. Consult your doctor||
0349|094|P|before breastfeeding.||
0349|095|B|||
0349|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0349|097|I|medications work or increase your risk for serious side effects.||
0349|098|I|This document does not contain all possible drug interactions.||
0349|099|I|Keep a list of all the products you use (including||
0349|100|I|prescription/nonprescription drugs and herbal products) and share||
0349|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0349|102|I|the dosage of any medicines without your doctor's approval.||
0349|103|B|||
0349|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0349|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0349|106|O|poison control center right away. US residents can call||
0349|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0349|108|B|||
0349|109|N|NOTES:  Your doctor will schedule periodic eye exams to monitor||
0349|110|N|your progress or check for side effects.||
0349|111|B|||
0349|112|D|MISSED DOSE:  Not applicable.||
0349|113|B|||
0349|114|R|STORAGE:  Not applicable. This medication is given in a clinic||
0349|115|R|and will not be stored at home.||
0349|116|B|||
0349|117|A|Information last revised June 2024.||
0349|118|A|Copyright(c) 2025 First Databank, Inc.||
0349|119|B|||
0355|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0355|002|Z|does NOT have all possible information about this product. This||
0355|003|Z|information does not assure that this product is safe, effective,||
0355|004|Z|or appropriate for you. This information is not individual||
0355|005|Z|medical advice and does not substitute for the advice of your||
0355|006|Z|health care professional. Always ask your health care||
0355|007|Z|professional for complete information about this product and your||
0355|008|Z|specific health needs.||
0355|009|B|||
0355|010|T|NITISINONE - ORAL||
0355|011|F|(nye-TIS-i-none)||
0355|012|B|||
0355|013|C|COMMON BRAND NAME(S): Orfadin||
0355|014|B|||
0355|015|U|USES:  Nitisinone is used to treat a certain inherited disorder||
0355|016|U|(hereditary tyrosinemia type 1, also known as HT-1). HT-1 is||
0355|017|U|usually discovered in infants and needs lifelong treatment. This||
0355|018|U|condition is caused by a shortage of a certain natural substance||
0355|019|U|that is needed to break down a nutrient (tyrosine) found in food.||
0355|020|U|This effect causes a build-up of too much tyrosine and related||
0355|021|U|substances in the liver. Nitisinone works by helping to prevent||
0355|022|U|the formation and build-up of several toxic substances that cause||
0355|023|U|damage to the liver, kidneys, and nervous system. This drug must||
0355|024|U|be used along with a diet low in protein, tyrosine, and||
0355|025|U|phenylalanine.||
0355|026|B|||
0355|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0355|028|H|from your pharmacist before you start taking nitisinone and each||
0355|029|H|time you get a refill. If you have any questions, ask your doctor||
0355|030|H|or pharmacist.||
0355|031|H|   Take this medication by mouth as directed by your doctor,||
0355|032|H|usually twice daily.||
0355|033|H|   If you are taking the capsules, take them on an empty stomach||
0355|034|H|at least 1 hour before or 2 hours after a meal. If you are unable||
0355|035|H|to swallow the capsules, you may open the capsules and mix the||
0355|036|H|contents in a small amount of water, formula, or apple sauce.||
0355|037|H|Take the mixture right away.||
0355|038|H|   If you are taking the suspension, you may take the suspension||
0355|039|H|with or without food. Shake the bottle well before each dose.||
0355|040|H|Carefully measure the dose using a special measuring||
0355|041|H|device/spoon. Do not use a household spoon because you may not||
0355|042|H|get the correct dose. When using an unopened bottle of suspension||
0355|043|H|for the first time, remove it from the refrigerator and let it||
0355|044|H|warm to room temperature for 30 to 60 minutes before use.||
0355|045|H|   If you are taking the tablets, you may take the tablets with||
0355|046|H|or without food. If you are unable to swallow the tablets, you||
0355|047|H|may crush the tablets and mix them in a small amount of water or||
0355|048|H|applesauce. Take the mixture right away. If you are using a||
0355|049|H|special measuring device/syringe to prepare and give the tablets||
0355|050|H|mixed with water, carefully follow the directions from the||
0355|051|H|manufacturer. Ask your doctor or pharmacist if you have any||
0355|052|H|questions.||
0355|053|H|   The dosage is based on your medical condition, weight, and||
0355|054|H|response to treatment. Your doctor may adjust your dose and||
0355|055|H|schedule based on your response to treatment. Carefully follow||
0355|056|H|your doctor's directions for taking this medication.||
0355|057|H|   Take this medication regularly to get the most benefit from||
0355|058|H|it. To help you remember, take it at the same time(s) each day.||
0355|059|H|   It is very important that patients taking this medication||
0355|060|H|follow a special diet low in protein, tyrosine, and||
0355|061|H|phenylalanine. Consult your doctor, pharmacist, or dietician for||
0355|062|H|more details. (See also Drug Interactions and Precautions||
0355|063|H|sections.)||
0355|064|B|||
0355|065|S|SIDE EFFECTS:  The suspension may cause headache, upset stomach,||
0355|066|S|or diarrhea. If any of these effects occur, tell your doctor or||
0355|067|S|pharmacist promptly and discuss switching to other forms of||
0355|068|S|nitisinone.||
0355|069|S|   Remember that this medication has been prescribed because the||
0355|070|S|doctor has judged that the benefit is greater than the risk of||
0355|071|S|side effects. Many people using this medication do not have||
0355|072|S|serious side effects.||
0355|073|S|   This medication may rarely cause a low number of blood cells||
0355|074|S|such as white cells and platelets. This effect can decrease your||
0355|075|S|body's ability to fight an infection or cause easy||
0355|076|S|bruising/bleeding. Tell your doctor right away if you develop any||
0355|077|S|of the following symptoms: signs of infection (such as sore||
0355|078|S|throat that doesn't go away, fever, chills), easy||
0355|079|S|bruising/bleeding.||
0355|080|S|   Your condition and this medication can cause liver problems.||
0355|081|S|Tell the doctor right away if any of these symptoms of liver||
0355|082|S|problems occur: nausea or vomiting that doesn't stop, severe||
0355|083|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
0355|084|S|   Your condition and this medication can cause high levels of||
0355|085|S|tyrosine in the blood. It is very important to follow the low||
0355|086|S|protein/low tyrosine diet recommended by your doctor. See also||
0355|087|S|Precautions section. Too much tyrosine may cause skin, eye, or||
0355|088|S|brain problems. Tell the doctor right away if any of these||
0355|089|S|symptoms occur: eye redness/itching/discharge, vision changes,||
0355|090|S|eye pain, eye sensitivity (especially to light), dry/itchy skin,||
0355|091|S|sores on palms of hands/soles of feet, developmental delays (such||
0355|092|S|as holding head up, rolling over, crawling).||
0355|093|S|   A very serious allergic reaction to this drug is rare.||
0355|094|S|However, get medical help right away if you notice any symptoms||
0355|095|S|of a serious allergic reaction, including: rash, itching/swelling||
0355|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0355|097|S|breathing.||
0355|098|S|   This is not a complete list of possible side effects. If you||
0355|099|S|notice other effects not listed above, contact the doctor or||
0355|100|S|pharmacist.||
0355|101|S|   In the US -||
0355|102|S|   Call your doctor for medical advice about side effects. You||
0355|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0355|104|S|www.fda.gov/medwatch.||
0355|105|S|   In Canada - Call your doctor for medical advice about side||
0355|106|S|effects. You may report side effects to Health Canada at||
0355|107|S|1-866-234-2345.||
0355|108|B|||
0355|109|P|PRECAUTIONS:  Before taking nitisinone, tell your doctor or||
0355|110|P|pharmacist if you are allergic to it; or if you have any other||
0355|111|P|allergies. This product may contain inactive ingredients, which||
0355|112|P|can cause allergic reactions or other problems. Talk to your||
0355|113|P|pharmacist for more details.||
0355|114|P|   Before using this medication, tell your doctor or pharmacist||
0355|115|P|your medical history, especially of: eye problems (such as||
0355|116|P|cataracts, corneal ulcers).||
0355|117|P|   Before having surgery, tell your doctor or dentist about all||
0355|118|P|the products you use (including prescription drugs,||
0355|119|P|nonprescription drugs, and herbal products).||
0355|120|P|   Patients taking this medication are at risk for developing||
0355|121|P|high levels of tyrosine in the blood, possibly leading to eye,||
0355|122|P|skin, and nervous system problems. (See Side effects section.) To||
0355|123|P|decrease the risk of high tyrosine levels, patients should follow||
0355|124|P|a diet low in tyrosine and phenylalanine. Avoid foods and||
0355|125|P|beverages that contain aspartame or are high in tyrosine or||
0355|126|P|phenylalanine. Foods high in tyrosine include soy products,||
0355|127|P|turkey, fish, avocados, bananas, yogurt, and lima beans. Foods||
0355|128|P|high in phenylalanine include milk, chicken, eggs, cheese, peanut||
0355|129|P|butter. (See also Drug Interactions section.)||
0355|130|P|   During pregnancy, this medication should be used only when||
0355|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
0355|132|P|   It is unknown if this drug passes into breast milk. Consult||
0355|133|P|your doctor before breastfeeding.||
0355|134|B|||
0355|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0355|136|I|medications work or increase your risk for serious side effects.||
0355|137|I|This document does not contain all possible drug interactions.||
0355|138|I|Keep a list of all the products you use (including||
0355|139|I|prescription/nonprescription drugs and herbal products) and share||
0355|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
0355|141|I|the dosage of any medicines without your doctor's approval.||
0355|142|I|   This medication can slow down the removal of other medications||
0355|143|I|from your body, which may affect how they work. Examples of||
0355|144|I|affected drugs include deuruxolitinib, ketorolac, among others.||
0355|145|I|   Many foods, drugs, or supplements may contain aspartame,||
0355|146|I|tyrosine, or phenylalanine, which must be limited in patients||
0355|147|I|taking this drug. Check the labels on all products (especially||
0355|148|I|artificially sweetened products) for aspartame, tyrosine and||
0355|149|I|phenylalanine content. Consult your doctor, pharmacist, or||
0355|150|I|dietician for more details.||
0355|151|B|||
0355|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0355|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0355|154|O|poison control center right away. US residents can call||
0355|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0355|156|B|||
0355|157|N|NOTES:  Do not share this medication with others.||
0355|158|N|   Lab and/or medical tests (such as eye exams, compete blood||
0355|159|N|count, liver function, blood and urine tests for tyrosine and||
0355|160|N|related substances) should be done while you are taking this||
0355|161|N|medication. Keep all medical and lab appointments. Consult your||
0355|162|N|doctor for more details.||
0355|163|B|||
0355|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0355|165|D|remember. If it is near the time of the next dose, skip the||
0355|166|D|missed dose. Take your next dose at the regular time. Do not||
0355|167|D|double the dose to catch up.||
0355|168|B|||
0355|169|R|STORAGE:  Store the tablets at room temperature. Store the||
0355|170|R|suspension in the refrigerator before the first use. Do not||
0355|171|R|freeze. After the first use, store the bottle of suspension at||
0355|172|R|room temperature. Once opened, the suspension expires after 60||
0355|173|R|days. Different brands of the capsule form of this medication||
0355|174|R|have different storage needs. Check the product package for||
0355|175|R|instructions on how to store your brand, or ask your pharmacist.||
0355|176|R|Keep all medications away from children and pets.||
0355|177|R|   Do not flush medications down the toilet or pour them into a||
0355|178|R|drain unless instructed to do so. Properly discard this product||
0355|179|R|when it is expired or no longer needed. Consult your pharmacist||
0355|180|R|or local waste disposal company.||
0355|181|B|||
0355|182|A|Information last revised June 2025.||
0355|183|A|Copyright(c) 2025 First Databank, Inc.||
0355|184|B|||
0357|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0357|002|Z|does NOT have all possible information about this product. This||
0357|003|Z|information does not assure that this product is safe, effective,||
0357|004|Z|or appropriate for you. This information is not individual||
0357|005|Z|medical advice and does not substitute for the advice of your||
0357|006|Z|health care professional. Always ask your health care||
0357|007|Z|professional for complete information about this product and your||
0357|008|Z|specific health needs.||
0357|009|B|||
0357|010|T|PROPYLENE GLYCOL/POLYETHYLENE GLYCOL GEL - NASAL||
0357|011|F|(PROE-pi-leen GLYE-kol/POL-ee-ETH-i-leen GLYE-kol)||
0357|012|B|||
0357|013|C|COMMON BRAND NAME(S): Rhinaris||
0357|014|B|||
0357|015|U|USES:  This product is used to treat dryness and irritation||
0357|016|U|inside the nose (nasal passages) caused by dry room air,||
0357|017|U|medications, allergies, colds, or other conditions. This product||
0357|018|U|helps add moisture inside the nose to dissolve and soften thick||
0357|019|U|or crusty mucus, making it easier to remove the mucus. This helps||
0357|020|U|to prevent nosebleeds, relieve a stuffy nose, and make breathing||
0357|021|U|easier.||
0357|022|U|   This product contains moisturizers in a gentle purified salt||
0357|023|U|solution (also called saline or sodium chloride solution). It||
0357|024|U|does not contain any medication.||
0357|025|B|||
0357|026|H|HOW TO USE:  With clean hands, apply a small amount of this||
0357|027|H|product into each nostril, usually every 4 hours or as needed.||
0357|028|H|Follow all directions on the product package. If you have any||
0357|029|H|questions, ask your doctor or pharmacist.||
0357|030|H|   If your condition lasts or gets worse, or if you think you may||
0357|031|H|have a serious medical problem, get medical help right away.||
0357|032|B|||
0357|033|S|SIDE EFFECTS:  Side effects usually do not occur with use of this||
0357|034|S|product. However, if the inside of your nose is very dry and||
0357|035|S|irritated, mild stinging may occur. If this effect lasts or gets||
0357|036|S|worse, tell your doctor or pharmacist promptly.||
0357|037|S|   If your doctor has directed you to use this medication,||
0357|038|S|remember that your doctor has judged that the benefit to you is||
0357|039|S|greater than the risk of side effects. Many people using this||
0357|040|S|medication do not have serious side effects.||
0357|041|S|   A very serious allergic reaction to this drug is rare.||
0357|042|S|However, get medical help right away if you notice any symptoms||
0357|043|S|of a serious allergic reaction, including: rash, itching/swelling||
0357|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0357|045|S|breathing.||
0357|046|S|   This is not a complete list of possible side effects. If you||
0357|047|S|notice other effects not listed above, contact your doctor or||
0357|048|S|pharmacist.||
0357|049|S|   In the US -||
0357|050|S|   Call your doctor for medical advice about side effects. You||
0357|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0357|052|S|www.fda.gov/medwatch.||
0357|053|S|   In Canada - Call your doctor for medical advice about side||
0357|054|S|effects. You may report side effects to Health Canada at||
0357|055|S|1-866-234-2345.||
0357|056|B|||
0357|057|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0357|058|P|pharmacist if you are allergic to any of its ingredients; or if||
0357|059|P|you have any other allergies. This product may contain inactive||
0357|060|P|ingredients, which can cause allergic reactions or other||
0357|061|P|problems. Talk to your pharmacist for more details.||
0357|062|P|   Before having surgery, tell your doctor or dentist about all||
0357|063|P|the products you use (including prescription drugs,||
0357|064|P|nonprescription drugs, and herbal products).||
0357|065|P|   This product is safe to use during pregnancy.||
0357|066|P|   This product is safe to use if you are breastfeeding.||
0357|067|B|||
0357|068|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0357|069|I|medications work or increase your risk for serious side effects.||
0357|070|I|This document does not contain all possible drug interactions.||
0357|071|I|Keep a list of all the products you use (including||
0357|072|I|prescription/nonprescription drugs and herbal products) and share||
0357|073|I|it with your doctor and pharmacist. Do not start, stop, or change||
0357|074|I|the dosage of any medicines without your doctor's approval.||
0357|075|B|||
0357|076|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0357|077|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0357|078|O|poison control center right away. US residents can call||
0357|079|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0357|080|B|||
0357|081|N|NOTES:  Do not share this product with others. Doing so may||
0357|082|N|increase the risk of infection. Keep the opening of the container||
0357|083|N|clean.||
0357|084|B|||
0357|085|D|MISSED DOSE:  Not applicable.||
0357|086|B|||
0357|087|R|STORAGE:  Refer to storage information printed on the package. If||
0357|088|R|you have any questions about storage, ask your pharmacist. Keep||
0357|089|R|all medications away from children and pets.||
0357|090|R|   Do not flush medications down the toilet or pour them into a||
0357|091|R|drain unless instructed to do so. Properly discard this product||
0357|092|R|when it is expired or no longer needed. Consult your pharmacist||
0357|093|R|or local waste disposal company.||
0357|094|B|||
0357|095|A|Information last revised September 2024.||
0357|096|A|Copyright(c) 2025 First Databank, Inc.||
0357|097|B|||
0358|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0358|002|Z|does NOT have all possible information about this product. This||
0358|003|Z|information does not assure that this product is safe, effective,||
0358|004|Z|or appropriate for you. This information is not individual||
0358|005|Z|medical advice and does not substitute for the advice of your||
0358|006|Z|health care professional. Always ask your health care||
0358|007|Z|professional for complete information about this product and your||
0358|008|Z|specific health needs.||
0358|009|B|||
0358|010|T|EPOPROSTENOL - INJECTION||
0358|011|F|(E-poe-PROST-en-ol)||
0358|012|B|||
0358|013|C|COMMON BRAND NAME(S): Flolan, Veletri||
0358|014|B|||
0358|015|U|USES:  This medication is used to treat high blood pressure in||
0358|016|U|the lungs (pulmonary arterial hypertension). It helps to increase||
0358|017|U|your ability to exercise and improve symptoms such as shortness||
0358|018|U|of breath and tiredness. It works by relaxing and widening the||
0358|019|U|blood vessels (arteries) in the lungs and other parts of the body||
0358|020|U|so that blood can flow more easily. This medication belongs to a||
0358|021|U|class of drugs known as vasodilators.||
0358|022|B|||
0358|023|H|HOW TO USE:  When you first start using this medication, it must||
0358|024|H|be given by a health care professional in a hospital or clinic.||
0358|025|H|This medication is given as a continuous injection into the vein||
0358|026|H|using an infusion pump as directed by your doctor.||
0358|027|H|   Follow all instructions from your health care professional||
0358|028|H|about how to properly use and prepare this medication and the||
0358|029|H|infusion pump. Before using, check this product for particles or||
0358|030|H|discoloration. If either is present, do not use the liquid, and||
0358|031|H|contact your health care professional right away. Learn how to||
0358|032|H|store and discard medical supplies safely. If you have any||
0358|033|H|questions about the use of this medication or the infusion pump,||
0358|034|H|consult your health care professional.||
0358|035|H|   Do not suddenly decrease the dose or suddenly stop using this||
0358|036|H|medication because doing either may lead to serious (rarely||
0358|037|H|fatal) worsening of your condition. If you must stop this||
0358|038|H|medication, gradually reduce the dose as directed by your doctor.||
0358|039|H|Consult your doctor right away if your infusion is interrupted or||
0358|040|H|if you develop worsening trouble breathing, dizziness, or||
0358|041|H|weakness. To avoid interruptions in drug treatment, you should||
0358|042|H|have a backup infusion pump and infusion sets available in case||
0358|043|H|your equipment fails. Consult your health care professional for||
0358|044|H|more information.||
0358|045|H|   The dosage is based on your medical condition, weight, and||
0358|046|H|response to treatment. Your doctor may also direct you to use||
0358|047|H|additional medications to treat your condition and prevent||
0358|048|H|problems. Use all prescribed medications exactly as directed.||
0358|049|H|   Tell your doctor if your condition does not get better or if||
0358|050|H|it gets worse.||
0358|051|B|||
0358|052|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, dizziness, headache,||
0358|053|S|flushing, sweating, abdominal pain, jaw pain, muscle/joint pain,||
0358|054|S|or pain/redness/swelling at the injection site may occur. If any||
0358|055|S|of these effects last or get worse, tell your doctor or||
0358|056|S|pharmacist promptly.||
0358|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
0358|058|S|slowly when rising from a sitting or lying position.||
0358|059|S|   Remember that this medication has been prescribed because your||
0358|060|S|doctor has judged that the benefit to you is greater than the||
0358|061|S|risk of side effects. Many people using this medication do not||
0358|062|S|have serious side effects.||
0358|063|S|   Tell your doctor right away if you have any serious side||
0358|064|S|effects, including: mental/mood changes (such as anxiety,||
0358|065|S|nervousness, confusion, agitation), signs of infection (such as||
0358|066|S|sore throat that doesn't go away, fever, chills),||
0358|067|S|numb/tingling/pale skin, fast/slow/irregular heartbeat, vision||
0358|068|S|changes, chest pain, unusual bruising/bleeding.||
0358|069|S|   A very serious allergic reaction to this drug is rare.||
0358|070|S|However, get medical help right away if you notice any symptoms||
0358|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0358|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0358|073|S|breathing.||
0358|074|S|   This is not a complete list of possible side effects. If you||
0358|075|S|notice other effects not listed above, contact your doctor or||
0358|076|S|pharmacist.||
0358|077|S|   In the US -||
0358|078|S|   Call your doctor for medical advice about side effects. You||
0358|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0358|080|S|www.fda.gov/medwatch.||
0358|081|S|   In Canada - Call your doctor for medical advice about side||
0358|082|S|effects. You may report side effects to Health Canada at||
0358|083|S|1-866-234-2345.||
0358|084|B|||
0358|085|P|PRECAUTIONS:  Before using epoprostenol, tell your doctor or||
0358|086|P|pharmacist if you are allergic to it; or if you have any other||
0358|087|P|allergies. This product may contain inactive ingredients, which||
0358|088|P|can cause allergic reactions or other problems. Talk to your||
0358|089|P|pharmacist for more details.||
0358|090|P|   Before using this medication, tell your doctor or pharmacist||
0358|091|P|your medical history, especially of: heart failure (on the left||
0358|092|P|side of the heart), bleeding problems (such as bleeding of the||
0358|093|P|stomach/intestines), blood disorders (such as thrombocytopenia),||
0358|094|P|liver disease.||
0358|095|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0358|096|P|can make you more dizzy. Do not drive, use machinery, or do||
0358|097|P|anything that needs alertness until you can do it safely. Limit||
0358|098|P|alcoholic beverages. Talk to your doctor if you are using||
0358|099|P|marijuana (cannabis).||
0358|100|P|   Before having surgery, tell your doctor or dentist about all||
0358|101|P|the products you use (including prescription drugs,||
0358|102|P|nonprescription drugs, and herbal products).||
0358|103|P|   During pregnancy, this medication should be used only when||
0358|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
0358|105|P|   It is unknown if this drug passes into breast milk. Consult||
0358|106|P|your doctor before breastfeeding.||
0358|107|B|||
0358|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0358|109|I|medications work or increase your risk for serious side effects.||
0358|110|I|This document does not contain all possible drug interactions.||
0358|111|I|Keep a list of all the products you use (including||
0358|112|I|prescription/nonprescription drugs and herbal products) and share||
0358|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
0358|114|I|the dosage of any medicines without your doctor's approval.||
0358|115|I|   Some products that may interact with this drug are:||
0358|116|I|antiplatelet drugs (such as clopidogrel).||
0358|117|I|   Check all prescription and nonprescription medicine labels||
0358|118|I|carefully since many contain pain relievers/fever reducers||
0358|119|I|(aspirin, NSAIDs such as ibuprofen, naproxen) that can increase||
0358|120|I|the risk of bleeding or medicines (such as cough-and-cold||
0358|121|I|products, diet aids) that could increase your blood pressure or||
0358|122|I|heart rate. Ask your pharmacist about using those products||
0358|123|I|safely.||
0358|124|I|   However, if your doctor has told you to take low-dose aspirin||
0358|125|I|to prevent heart attack or stroke (usually 81-162 milligrams a||
0358|126|I|day), you should keep taking the aspirin unless your doctor tells||
0358|127|I|you not to. Ask your doctor or pharmacist for more details.||
0358|128|B|||
0358|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0358|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0358|131|O|poison control center right away. US residents can call||
0358|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0358|133|O|Symptoms of overdose may include: severe dizziness.||
0358|134|B|||
0358|135|N|NOTES:  Do not share this medication with others.||
0358|136|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
0358|137|N|should be done while you are using this medication. Keep all||
0358|138|N|medical and lab appointments. Consult your doctor for more||
0358|139|N|details.||
0358|140|B|||
0358|141|D|MISSED DOSE:  This drug is to be given continuously as an||
0358|142|D|infusion. If your infusion is interrupted, contact your doctor or||
0358|143|D|pharmacist right away.||
0358|144|B|||
0358|145|R|STORAGE:  Store unopened vials at room temperature away from||
0358|146|R|light. Do not freeze. Consult your pharmacist for details about||
0358|147|R|the storage of opened vials and prepared solutions. Keep all||
0358|148|R|medications away from children and pets.||
0358|149|R|   Do not flush medications down the toilet or pour them into a||
0358|150|R|drain unless instructed to do so. Properly discard this product||
0358|151|R|when it is expired or no longer needed. Consult your pharmacist||
0358|152|R|or local waste disposal company.||
0358|153|B|||
0358|154|M|MEDICAL ALERT:  Your condition can cause complications in a||
0358|155|M|medical emergency. For information about enrolling in MedicAlert,||
0358|156|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0358|157|B|||
0358|158|A|Information last revised April 2025.||
0358|159|A|Copyright(c) 2025 First Databank, Inc.||
0358|160|B|||
0359|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0359|002|Z|does NOT have all possible information about this product. This||
0359|003|Z|information does not assure that this product is safe, effective,||
0359|004|Z|or appropriate for you. This information is not individual||
0359|005|Z|medical advice and does not substitute for the advice of your||
0359|006|Z|health care professional. Always ask your health care||
0359|007|Z|professional for complete information about this product and your||
0359|008|Z|specific health needs.||
0359|009|B|||
0359|010|T|RASBURICASE - INJECTION||
0359|011|F|(ras-BURE-i-kase)||
0359|012|B|||
0359|013|C|COMMON BRAND NAME(S): Elitek||
0359|014|B|||
0359|015|W|WARNING:  This drug can cause a severe allergic reaction. If you||
0359|016|W|develop new symptoms such as chest pain, trouble breathing,||
0359|017|W|severe dizziness, itching/swelling (especially of the||
0359|018|W|face/tongue/throat), or rash/hives, stop using this medication||
0359|019|W|and get medical help right away. Do not restart this medication||
0359|020|W|if this severe allergic reaction has occurred. Consult the doctor||
0359|021|W|or pharmacist for more details.||
0359|022|W|   Do not take this medication if you have a metabolic condition||
0359|023|W|called glucose-6-phosphate dehydrogenase (G6PD) deficiency||
0359|024|W|because it can severely damage your red blood cells leading to||
0359|025|W|anemia (hemolysis). If you are of African or Mediterranean||
0359|026|W|descent, you may be at higher risk for G6PD deficiency and you||
0359|027|W|should be tested to see if you have this condition before||
0359|028|W|starting this medication.||
0359|029|W|   This medication can cause a condition that affects the ability||
0359|030|W|of your red blood cells to carry oxygen (methemoglobinemia). Do||
0359|031|W|not restart this medication if this effect occurs; consult the||
0359|032|W|doctor for details.||
0359|033|W|   This medication can interfere with uric acid blood levels,||
0359|034|W|resulting in falsely low levels (see Drug Interactions section).||
0359|035|W|Be sure to tell all lab personnel that you are using this drug.||
0359|036|B|||
0359|037|U|USES:  This medication is used to prevent high blood levels of||
0359|038|U|uric acid from occurring in children with cancer (such as||
0359|039|U|leukemia, lymphoma, solid malignant tumors) who are about to||
0359|040|U|receive cancer chemotherapy treatment. When chemotherapy is||
0359|041|U|given, cancer cells are destroyed, releasing large amounts of||
0359|042|U|uric acid into the bloodstream. This medication allows uric acid||
0359|043|U|to more easily be removed from the body by the kidneys.||
0359|044|B|||
0359|045|H|HOW TO USE:  This medication is given by injection into a vein as||
0359|046|H|directed by your doctor, usually over 30 minutes. Rasburicase is||
0359|047|H|given once a day for 5 days. Timing of cancer chemotherapy and||
0359|048|H|rasburicase doses is important. Chemotherapy is usually started 4||
0359|049|H|to 24 hours after the first dose of rasburicase.||
0359|050|H|   Fluids are also given into the vein with this medication to||
0359|051|H|help decrease your uric acid levels.||
0359|052|B|||
0359|053|S|SIDE EFFECTS:  See also Warning section.||
0359|054|S|   Nausea, vomiting, headache, stomach pain, constipation,||
0359|055|S|diarrhea, or mouth sores/ulcers may occur. If any of these||
0359|056|S|effects last or get worse, tell your doctor or pharmacist||
0359|057|S|promptly.||
0359|058|S|   Remember that this medication has been prescribed because your||
0359|059|S|doctor has judged that the benefit to you is greater than the||
0359|060|S|risk of side effects. Many people using this medication do not||
0359|061|S|have serious side effects.||
0359|062|S|   Tell your doctor right away if you have any serious side||
0359|063|S|effects, including: signs of infection (such as sore throat that||
0359|064|S|doesn't go away, fever, chills).||
0359|065|S|   Get medical help right away if you have any very serious side||
0359|066|S|effects, including: weakness, yellowing eyes/skin, dark urine,||
0359|067|S|blue/gray skin color.||
0359|068|S|   This is not a complete list of possible side effects. If you||
0359|069|S|notice other effects not listed above, contact the doctor or||
0359|070|S|pharmacist.||
0359|071|S|   In the US -||
0359|072|S|   Call your doctor for medical advice about side effects. You||
0359|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0359|074|S|www.fda.gov/medwatch.||
0359|075|S|   In Canada - Call your doctor for medical advice about side||
0359|076|S|effects. You may report side effects to Health Canada at||
0359|077|S|1-866-234-2345.||
0359|078|B|||
0359|079|P|PRECAUTIONS:  See also Warning section.||
0359|080|P|   Before using this medication, tell your doctor or pharmacist||
0359|081|P|if you are allergic to it; or if you have any other allergies.||
0359|082|P|This product may contain inactive ingredients, which can cause||
0359|083|P|allergic reactions or other problems. Talk to your pharmacist for||
0359|084|P|more details.||
0359|085|P|   Before using this medication, tell your doctor or pharmacist||
0359|086|P|your medical history, especially of: certain metabolic conditions||
0359|087|P|(such as G6PD deficiency), previous red blood cell damage (such||
0359|088|P|as hemolysis, methemoglobinemia) with this medication, kidney||
0359|089|P|disease, dehydration.||
0359|090|P|   Before having surgery, tell your doctor or dentist about all||
0359|091|P|the products you use (including prescription drugs,||
0359|092|P|nonprescription drugs, and herbal products).||
0359|093|P|   Children less than 2 years old may be more sensitive to the||
0359|094|P|side effects of this drug.||
0359|095|P|   During pregnancy, this medication should be used only when||
0359|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
0359|097|P|   It is unknown if this drug passes into breast milk. Because of||
0359|098|P|the possible risk to the infant, breastfeeding is not recommended||
0359|099|P|while using this drug and for 2 weeks after the last dose.||
0359|100|B|||
0359|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0359|102|I|medications work or increase your risk for serious side effects.||
0359|103|I|This document does not contain all possible drug interactions.||
0359|104|I|Keep a list of all the products you use (including||
0359|105|I|prescription/nonprescription drugs and herbal products) and share||
0359|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
0359|107|I|the dosage of any medicines without your doctor's approval.||
0359|108|I|   This medication can interfere with the uric acid in the blood||
0359|109|I|sample tubes when the tubes remain at room temperature, leading||
0359|110|I|to falsely low uric acid results. Lab personnel must follow||
0359|111|I|special procedures to process the blood sample.||
0359|112|B|||
0359|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0359|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0359|115|O|poison control center right away. US residents can call||
0359|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0359|117|B|||
0359|118|N|NOTES:  Lab and/or medical tests (such as uric acid levels)||
0359|119|N|should be done while you are using this medication. Keep all||
0359|120|N|medical and lab appointments. Consult your doctor for more||
0359|121|N|details.||
0359|122|B|||
0359|123|D|MISSED DOSE:  It is important to get each dose as scheduled. If||
0359|124|D|you miss a dose, ask your doctor or pharmacist right away for a||
0359|125|D|new schedule.||
0359|126|B|||
0359|127|R|STORAGE:  Not applicable. This medication is given in a hospital||
0359|128|R|or clinic and will not be stored at home.||
0359|129|B|||
0359|130|A|Information last revised May 2024.||
0359|131|A|Copyright(c) 2025 First Databank, Inc.||
0359|132|B|||
0360|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0360|002|Z|does NOT have all possible information about this product. This||
0360|003|Z|information does not assure that this product is safe, effective,||
0360|004|Z|or appropriate for you. This information is not individual||
0360|005|Z|medical advice and does not substitute for the advice of your||
0360|006|Z|health care professional. Always ask your health care||
0360|007|Z|professional for complete information about this product and your||
0360|008|Z|specific health needs.||
0360|009|B|||
0360|010|T|TERIPARATIDE - INJECTION||
0360|011|F|(TER-i-PAR-a-tide)||
0360|012|B|||
0360|013|C|COMMON BRAND NAME(S): Forteo||
0360|014|B|||
0360|015|U|USES:  Teriparatide is used to treat bone loss (osteoporosis) in||
0360|016|U|people who have a high risk of getting fractures. It is similar||
0360|017|U|to a natural hormone in your body (parathyroid hormone). It works||
0360|018|U|by increasing bone mass and strength. This effect helps to||
0360|019|U|decrease the risk of getting a fracture.||
0360|020|U|   This medication is not recommended for use in children or||
0360|021|U|young adults whose bones are still growing.||
0360|022|B|||
0360|023|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
0360|024|H|provided by your pharmacist before you start using teriparatide||
0360|025|H|and each time you get a refill. Ask your health care professional||
0360|026|H|how to prepare and use this medication. If you have any||
0360|027|H|questions, ask your doctor or pharmacist.||
0360|028|H|   Inject this medication under the skin as directed by your||
0360|029|H|doctor, usually once daily. The injection is given in the thigh||
0360|030|H|or abdomen.||
0360|031|H|   Before using, check this product for particles or||
0360|032|H|discoloration. If either is present, do not use the liquid.||
0360|033|H|Before injecting each dose, clean the skin you are going to||
0360|034|H|inject into (the injection site) with rubbing alcohol. Change the||
0360|035|H|injection site each time to lessen injury under the skin. To||
0360|036|H|lessen bruising, do not rub the injection site after a shot.||
0360|037|H|Learn how to store and discard medical supplies safely.||
0360|038|H|   Use this medication regularly to get the most benefit from it.||
0360|039|H|To help you remember, use it at the same time each day.||
0360|040|B|||
0360|041|S|SIDE EFFECTS:  Dizziness or fast heartbeat may occur within 4||
0360|042|S|hours after using this medication. These symptoms may last for a||
0360|043|S|few minutes to a few hours. This effect should go away after||
0360|044|S|several doses as your body adjusts to the medication. It is best||
0360|045|S|to lie or sit down if these symptoms occur. Muscle cramps/spasms,||
0360|046|S|nausea, or pain/swelling/bruising at the injection site may also||
0360|047|S|occur. If any of these effects last or get worse, tell your||
0360|048|S|doctor or pharmacist promptly.||
0360|049|S|   To reduce the risk of dizziness and lightheadedness, get up||
0360|050|S|slowly when rising from a sitting or lying position.||
0360|051|S|   Remember that this medication has been prescribed because your||
0360|052|S|doctor has judged that the benefit to you is greater than the||
0360|053|S|risk of side effects. Many people using this medication do not||
0360|054|S|have serious side effects.||
0360|055|S|   Tell your doctor right away if you have any serious side||
0360|056|S|effects, including: fainting, constipation, unusual tiredness,||
0360|057|S|mental/mood changes (such as confusion), purplish spots on the||
0360|058|S|skin, skin ulcers/lesions.||
0360|059|S|   Teriparatide has been shown to increase bone cancer||
0360|060|S|(osteosarcoma) in rats. It is unknown if this medication can||
0360|061|S|cause bone cancer in humans. Tell your doctor right away if you||
0360|062|S|have any symptoms of bone cancer, including: bone pain, unusual||
0360|063|S|growths/lumps.||
0360|064|S|   A very serious allergic reaction to this drug is rare.||
0360|065|S|However, get medical help right away if you notice any symptoms||
0360|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0360|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0360|068|S|breathing.||
0360|069|S|   This is not a complete list of possible side effects. If you||
0360|070|S|notice other effects not listed above, contact your doctor or||
0360|071|S|pharmacist.||
0360|072|S|   In the US -||
0360|073|S|   Call your doctor for medical advice about side effects. You||
0360|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0360|075|S|www.fda.gov/medwatch.||
0360|076|S|   In Canada - Call your doctor for medical advice about side||
0360|077|S|effects. You may report side effects to Health Canada at||
0360|078|S|1-866-234-2345.||
0360|079|B|||
0360|080|P|PRECAUTIONS:  Before using teriparatide, tell your doctor or||
0360|081|P|pharmacist if you are allergic to it; or if you have any other||
0360|082|P|allergies. This product may contain inactive ingredients, which||
0360|083|P|can cause allergic reactions or other problems. Talk to your||
0360|084|P|pharmacist for more details.||
0360|085|P|   Before using this medication, tell your doctor or pharmacist||
0360|086|P|your medical history, especially of: other bone disorders (such||
0360|087|P|as Paget's disease), personal/family history of bone cancer,||
0360|088|P|radiation treatment, high level of calcium in the blood||
0360|089|P|(hypercalcemia), kidney stones.||
0360|090|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0360|091|P|can make you more dizzy. Do not drive, use machinery, or do||
0360|092|P|anything that needs alertness until you can do it safely. Limit||
0360|093|P|alcoholic beverages. Talk to your doctor if you are using||
0360|094|P|marijuana (cannabis).||
0360|095|P|   Before having surgery, tell your doctor or dentist about all||
0360|096|P|the products you use (including prescription drugs,||
0360|097|P|nonprescription drugs, and herbal products).||
0360|098|P|   During pregnancy, this medication should be used only when||
0360|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
0360|100|P|   It is unknown if this medication passes into breast milk.||
0360|101|P|Because of the possible risk to the infant, breastfeeding is not||
0360|102|P|recommended while using this medication. Consult your doctor||
0360|103|P|before breastfeeding.||
0360|104|B|||
0360|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0360|106|I|medications work or increase your risk for serious side effects.||
0360|107|I|This document does not contain all possible drug interactions.||
0360|108|I|Keep a list of all the products you use (including||
0360|109|I|prescription/nonprescription drugs and herbal products) and share||
0360|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0360|111|I|the dosage of any medicines without your doctor's approval.||
0360|112|B|||
0360|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0360|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0360|115|O|poison control center right away. US residents can call||
0360|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0360|117|O|Symptoms of overdose may include: vomiting, severe dizziness,||
0360|118|O|unusual tiredness.||
0360|119|B|||
0360|120|N|NOTES:  Do not share this medication with others.||
0360|121|N|   Lab and/or medical tests (such as calcium levels) should be||
0360|122|N|done while you are using this medication. Keep all medical and||
0360|123|N|lab appointments. Consult your doctor for more details.||
0360|124|N|   Lifestyle changes that help promote healthy bones include||
0360|125|N|increasing weight-bearing exercise, stopping smoking, limiting||
0360|126|N|alcohol, and eating well-balanced meals that contain adequate||
0360|127|N|calcium and vitamin D. Since you may also need to take calcium||
0360|128|N|and vitamin D supplements and make lifestyle changes, consult||
0360|129|N|your doctor for specific advice.||
0360|130|B|||
0360|131|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0360|132|D|If you don't remember until the next day, skip the missed dose.||
0360|133|D|Use your next dose at the regular time. Do not double the dose to||
0360|134|D|catch up.||
0360|135|B|||
0360|136|R|STORAGE:  Store in the refrigerator away from light. Do not||
0360|137|R|freeze. Do not use this medication if it has been frozen. This||
0360|138|R|medication should be used immediately after removing from the||
0360|139|R|refrigerator and then returned to refrigerator after use. This||
0360|140|R|product may be used for up to 28 days. Mark the day when you||
0360|141|R|start using the product. Discard the product after 28 days, even||
0360|142|R|if there is still medication in the product. Keep all medications||
0360|143|R|away from children and pets.||
0360|144|R|   Do not flush medications down the toilet or pour them into a||
0360|145|R|drain unless instructed to do so. Properly discard this product||
0360|146|R|when it is expired or no longer needed. Consult your pharmacist||
0360|147|R|or local waste disposal company.||
0360|148|B|||
0360|149|A|Information last revised August 2024.||
0360|150|A|Copyright(c) 2025 First Databank, Inc.||
0360|151|B|||
0361|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0361|002|Z|does NOT have all possible information about this product. This||
0361|003|Z|information does not assure that this product is safe, effective,||
0361|004|Z|or appropriate for you. This information is not individual||
0361|005|Z|medical advice and does not substitute for the advice of your||
0361|006|Z|health care professional. Always ask your health care||
0361|007|Z|professional for complete information about this product and your||
0361|008|Z|specific health needs.||
0361|009|B|||
0361|010|T|LACTOBACILLUS ACIDOPHILUS - ORAL||
0361|011|B|||
0361|012|U|USES:  This product contains the bacteria Lactobacillus||
0361|013|U|acidophilus, which is naturally found in the stomach/intestines.||
0361|014|U|Some conditions (such as antibiotic use) can cause problems with||
0361|015|U|the normal balance of bacteria in the stomach/intestines,||
0361|016|U|resulting in diarrhea. This product can help restore the normal||
0361|017|U|balance of intestinal bacteria. This product has been used for||
0361|018|U|diarrhea and other stomach/intestinal problems. It has also been||
0361|019|U|used for vaginal and urinary tract infections.||
0361|020|U|   Do not use in children younger than 3 years of age unless||
0361|021|U|directed by your doctor.||
0361|022|U|   Some diet supplement products have been found to contain||
0361|023|U|possibly harmful impurities/additives. Check with your pharmacist||
0361|024|U|for more details regarding the particular brand you use.||
0361|025|U|   The FDA has not reviewed this product for safety or||
0361|026|U|effectiveness. Consult your doctor or pharmacist for more||
0361|027|U|details.||
0361|028|B|||
0361|029|H|HOW TO USE:  Take this product by mouth. Refer to the label||
0361|030|H|directions for your specific product to see if it should be taken||
0361|031|H|with or without food or liquids (such as milk, fruit juice, or||
0361|032|H|water). Refer to the label directions for your specific product||
0361|033|H|to see if the dose should be swallowed whole, chewed, sprinkled||
0361|034|H|onto food or mixed with liquid. If you have questions about any||
0361|035|H|of the information, consult your doctor or pharmacist.||
0361|036|H|   Antibiotics may prevent this product from working well. Take||
0361|037|H|this product at least 2 to 3 hours before or after taking||
0361|038|H|antibiotics. Follow the direction for your specific product.||
0361|039|H|   If you are using this product for diarrhea due to antibiotics,||
0361|040|H|do not use for more than 2 days or if you have a high fever||
0361|041|H|unless directed by your doctor.||
0361|042|H|   If your condition lasts or gets worse or you think you may||
0361|043|H|have a serious medical problem, get medical help right away.||
0361|044|B|||
0361|045|S|SIDE EFFECTS:  An increase in stomach gas may occur, but usually||
0361|046|S|goes away with continued treatment. If this effect lasts or gets||
0361|047|S|worse, notify your doctor or pharmacist promptly.||
0361|048|S|   If your doctor has directed you to use this medication,||
0361|049|S|remember that your doctor has judged that the benefit to you is||
0361|050|S|greater than the risk of side effects. Many people using this||
0361|051|S|medication do not have serious side effects.||
0361|052|S|   Tell your doctor right away if you have any serious side||
0361|053|S|effects, including: signs of infection (such as sore throat that||
0361|054|S|doesn't go away, fever, chills).||
0361|055|S|   A very serious allergic reaction to this product is rare.||
0361|056|S|However, get medical help right away if you notice any symptoms||
0361|057|S|of a serious allergic reaction, including: rash, itching/swelling||
0361|058|S|(especially of the face/tongue/throat), dizziness, trouble||
0361|059|S|breathing.||
0361|060|S|   This is not a complete list of possible side effects. If you||
0361|061|S|notice other effects not listed above, contact your doctor or||
0361|062|S|pharmacist.||
0361|063|S|   In the US -||
0361|064|S|   Call your doctor for medical advice about side effects. You||
0361|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0361|066|S|www.fda.gov/medwatch.||
0361|067|S|   In Canada - Call your doctor for medical advice about side||
0361|068|S|effects. You may report side effects to Health Canada at||
0361|069|S|1-866-234-2345.||
0361|070|B|||
0361|071|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0361|072|P|pharmacist if you are allergic to it; or to milk/lactose||
0361|073|P|products; or if you have any other allergies. This product may||
0361|074|P|contain inactive ingredients, which can cause allergic reactions||
0361|075|P|or other problems. Talk to your pharmacist for more details.||
0361|076|P|   Before using this product, tell your doctor or pharmacist your||
0361|077|P|medical history, especially of: diarrhea lasting more than 2 days||
0361|078|P|(especially if you also have a high fever), weakened immune||
0361|079|P|system (such as due to chemotherapy, HIV infection), other||
0361|080|P|stomach problems, recurring vaginal infections, recurring urinary||
0361|081|P|tract infections.||
0361|082|P|   Before having surgery, tell your doctor or dentist about all||
0361|083|P|the products you use (including prescription drugs,||
0361|084|P|nonprescription drugs, and herbal products).||
0361|085|P|   Tell your doctor if you are pregnant or breastfeeding before||
0361|086|P|using this product.||
0361|087|B|||
0361|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0361|089|I|medications work or increase your risk for serious side effects.||
0361|090|I|This document does not contain all possible drug interactions.||
0361|091|I|Keep a list of all the products you use (including||
0361|092|I|prescription/nonprescription drugs and herbal products) and share||
0361|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
0361|094|I|the dosage of any medicines without your doctor's approval..||
0361|095|B|||
0361|096|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0361|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0361|098|O|poison control center right away. US residents can call||
0361|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0361|100|B|||
0361|101|N|NOTES:  Do not share this product with others.||
0361|102|B|||
0361|103|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0361|104|D|If it is near the time of the next dose, skip the missed dose.||
0361|105|D|Use your next dose at the regular time. Do not double the dose to||
0361|106|D|catch up.||
0361|107|B|||
0361|108|R|STORAGE:  Refer to the storage information printed on the||
0361|109|R|package. If you have any questions about storage, ask your||
0361|110|R|pharmacist. Do not store in the bathroom. Keep all medications||
0361|111|R|away from children and pets.||
0361|112|R|   Do not flush medications down the toilet or pour them into a||
0361|113|R|drain unless instructed to do so. Properly discard this product||
0361|114|R|when it is expired or no longer needed. Consult your pharmacist||
0361|115|R|or local waste disposal company.||
0361|116|B|||
0361|117|A|Information last revised April 2025.||
0361|118|A|Copyright(c) 2025 First Databank, Inc.||
0361|119|B|||
0362|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0362|002|Z|does NOT have all possible information about this product. This||
0362|003|Z|information does not assure that this product is safe, effective,||
0362|004|Z|or appropriate for you. This information is not individual||
0362|005|Z|medical advice and does not substitute for the advice of your||
0362|006|Z|health care professional. Always ask your health care||
0362|007|Z|professional for complete information about this product and your||
0362|008|Z|specific health needs.||
0362|009|B|||
0362|010|T|ATOMOXETINE - ORAL||
0362|011|F|(A-toe-MOX-e-teen)||
0362|012|B|||
0362|013|C|COMMON BRAND NAME(S): Strattera||
0362|014|B|||
0362|015|W|WARNING:  A small number of people (especially||
0362|016|W|children/teenagers) who take atomoxetine for attention-deficit||
0362|017|W|hyperactivity disorder (ADHD) may experience worsening of their||
0362|018|W|condition, other mental/mood symptoms, or suicidal||
0362|019|W|thoughts/attempts. It is very important to talk with the doctor||
0362|020|W|about the risks and benefits of this medication (especially for||
0362|021|W|children/teenagers).||
0362|022|W|   Tell the doctor right away if you notice worsening of your||
0362|023|W|condition/other psychiatric conditions, unusual behavior changes||
0362|024|W|(including possible suicidal thoughts/attempts), or other||
0362|025|W|mental/mood changes (including new/worsening anxiety, panic||
0362|026|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0362|027|W|hallucinations, delusions, impulsive actions, severe||
0362|028|W|restlessness, very rapid speech). Be especially watchful for||
0362|029|W|these symptoms when you first start this medication or when the||
0362|030|W|dose is changed.||
0362|031|B|||
0362|032|U|USES:  Atomoxetine is used to treat attention-deficit||
0362|033|U|hyperactivity disorder (ADHD) as part of a total treatment plan,||
0362|034|U|including psychological, social, and other treatments. It may||
0362|035|U|help to increase the ability to pay attention, concentrate, stay||
0362|036|U|focused, and stop fidgeting. It is thought to work by restoring||
0362|037|U|the balance of certain natural substances (neurotransmitters) in||
0362|038|U|the brain.||
0362|039|B|||
0362|040|H|HOW TO USE:  Read the Medication Guide provided by your||
0362|041|H|pharmacist before you start using atomoxetine and each time you||
0362|042|H|get a refill. If you have any questions, ask your doctor or||
0362|043|H|pharmacist.||
0362|044|H|   Take this medication with or without food as directed by your||
0362|045|H|doctor, usually 1 to 2 times a day. The first dose is usually||
0362|046|H|taken when you wake up in the morning. If a second dose is||
0362|047|H|prescribed, take it as directed by your doctor, usually in the||
0362|048|H|late afternoon/early evening. Taking this medication late in the||
0362|049|H|day may cause trouble sleeping (insomnia).||
0362|050|H|   Swallow the capsules whole. Do not crush, chew, or open the||
0362|051|H|capsules. If the capsule is accidentally opened or broken, avoid||
0362|052|H|contact with the powder and wash away any loose powder as soon as||
0362|053|H|possible with water. If the powder gets in your eyes, flush with||
0362|054|H|plenty of water right away and contact your doctor.||
0362|055|H|   The dosage is based on your medical condition, response to||
0362|056|H|treatment, and other drugs you may be taking. Be sure to tell||
0362|057|H|your doctor and pharmacist about all the products you use||
0362|058|H|(including prescription drugs, nonprescription drugs, and herbal||
0362|059|H|products). Do not increase your dose or take this drug more often||
0362|060|H|than directed.||
0362|061|H|   Use this medication regularly to get the most benefit from it.||
0362|062|H|To help you remember, take it at the same time(s) each day.||
0362|063|H|   Tell your doctor if your condition does not get better or if||
0362|064|H|it gets worse.||
0362|065|B|||
0362|066|S|SIDE EFFECTS:  See also Warning section.||
0362|067|S|   Stomach upset, nausea, vomiting, constipation, tiredness, loss||
0362|068|S|of appetite/weight loss, dry mouth, dizziness, drowsiness,||
0362|069|S|trouble sleeping, or decrease in sexual ability/desire may occur.||
0362|070|S|In women, menstrual cramps or missed/irregular periods may also||
0362|071|S|occur. If any of these effects last or get worse, tell your||
0362|072|S|doctor or pharmacist promptly.||
0362|073|S|   To lessen the chance of dizziness, get up slowly from a||
0362|074|S|sitting or lying position.||
0362|075|S|   Remember that this medication has been prescribed because your||
0362|076|S|doctor has judged that the benefit to you is greater than the||
0362|077|S|risk of side effects. Many people using this medication do not||
0362|078|S|have serious side effects.||
0362|079|S|   This medication may raise your blood pressure. Check your||
0362|080|S|blood pressure regularly and tell your doctor if the results are||
0362|081|S|high.||
0362|082|S|   Tell your doctor right away if you have any serious side||
0362|083|S|effects, including: difficulty urinating, unusually||
0362|084|S|fast/irregular heartbeat, fainting, numbness/tingling.||
0362|085|S|   Atomoxetine may rarely cause serious (possibly fatal) liver||
0362|086|S|disease. Get medical help right away if you have any symptoms of||
0362|087|S|liver damage, including: nausea/vomiting that doesn't stop, dark||
0362|088|S|urine, stomach/abdominal pain, yellowing eyes/skin.||
0362|089|S|   This medication may rarely cause serious problems such as a||
0362|090|S|heart attack or stroke. Get medical help right away if you||
0362|091|S|experience any of the following: chest/jaw/left arm pain,||
0362|092|S|shortness of breath, unusual sweating, weakness on one side of||
0362|093|S|the body, confusion, trouble speaking, sudden vision changes.||
0362|094|S|   Rarely, males (including young boys and teens) may have a||
0362|095|S|painful or prolonged erection lasting 4 or more hours while using||
0362|096|S|this medication. Caregivers/parents should also be watchful for||
0362|097|S|this serious side effect in boys. If a painful or prolonged||
0362|098|S|erection occurs, stop using this drug and get medical help right||
0362|099|S|away, or permanent problems could occur. Ask your doctor or||
0362|100|S|pharmacist for more details.||
0362|101|S|   A very serious allergic reaction to this drug is rare.||
0362|102|S|However, get medical help right away if you notice any symptoms||
0362|103|S|of a serious allergic reaction, including: rash, itching/swelling||
0362|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0362|105|S|breathing.||
0362|106|S|   This is not a complete list of possible side effects. If you||
0362|107|S|notice other effects not listed above, contact your doctor or||
0362|108|S|pharmacist.||
0362|109|S|   In the US -||
0362|110|S|   Call your doctor for medical advice about side effects. You||
0362|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0362|112|S|www.fda.gov/medwatch.||
0362|113|S|   In Canada - Call your doctor for medical advice about side||
0362|114|S|effects. You may report side effects to Health Canada at||
0362|115|S|1-866-234-2345.||
0362|116|B|||
0362|117|P|PRECAUTIONS:  Before taking atomoxetine, tell your doctor or||
0362|118|P|pharmacist if you are allergic to it; or if you have any other||
0362|119|P|allergies. This product may contain inactive ingredients, which||
0362|120|P|can cause allergic reactions or other problems. Talk to your||
0362|121|P|pharmacist for more details.||
0362|122|P|   Before using this medication, tell your doctor or pharmacist||
0362|123|P|your medical history, especially of: a certain adrenal gland||
0362|124|P|tumor (pheochromocytoma), bladder or prostate problems, glaucoma,||
0362|125|P|heart problems (such as irregular heartbeat, heart failure,||
0362|126|P|previous heart attack, problems with heart structure), family||
0362|127|P|history of heart problems (such as sudden cardiac death,||
0362|128|P|irregular heartbeat), high blood pressure, liver disease,||
0362|129|P|personal/family history of mental/mood disorders (such as bipolar||
0362|130|P|disorder, depression, psychosis, suicidal thoughts), stroke.||
0362|131|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0362|132|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0362|133|P|machinery, or do anything that needs alertness until you can do||
0362|134|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0362|135|P|are using marijuana (cannabis).||
0362|136|P|   Before having surgery, tell your doctor or dentist about all||
0362|137|P|the products you use (including prescription drugs,||
0362|138|P|nonprescription drugs, and herbal products).||
0362|139|P|   If used for a long time, this drug may affect a child's growth||
0362|140|P|rate, weight, and final adult height. To reduce the risk, the||
0362|141|P|doctor may recommend briefly stopping the medication from time to||
0362|142|P|time. Check the child's weight and height regularly, and consult||
0362|143|P|your doctor or pharmacist for more details.||
0362|144|P|   During pregnancy, this medication should be used only when||
0362|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
0362|146|P|   It is unknown if this drug passes into breast milk. Consult||
0362|147|P|your doctor before breastfeeding.||
0362|148|B|||
0362|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0362|150|I|medications work or increase your risk for serious side effects.||
0362|151|I|This document does not contain all possible drug interactions.||
0362|152|I|Keep a list of all the products you use (including||
0362|153|I|prescription/nonprescription drugs and herbal products) and share||
0362|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
0362|155|I|the dosage of any medicines without your doctor's approval.||
0362|156|I|   Taking MAO inhibitors with this medication may cause a serious||
0362|157|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0362|158|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0362|159|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0362|160|I|selegiline, tranylcypromine) during treatment with this||
0362|161|I|medication. Most MAO inhibitors should also not be taken for two||
0362|162|I|weeks before and after treatment with this medication. Ask your||
0362|163|I|doctor when to start or stop taking this medication.||
0362|164|I|   Some products have ingredients that could raise your heart||
0362|165|I|rate or blood pressure. Tell your pharmacist what products you||
0362|166|I|are using, and ask how to use them safely (especially||
0362|167|I|cough-and-cold products or diet aids).||
0362|168|B|||
0362|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0362|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0362|171|O|poison control center right away. US residents can call||
0362|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0362|173|O|Symptoms of overdose may include: unusually fast heartbeat,||
0362|174|O|severe headache.||
0362|175|B|||
0362|176|N|NOTES:  Do not share this medication with others.||
0362|177|N|   Lab and/or medical tests (such as pulse, blood pressure,||
0362|178|N|liver/heart function) may be done while you are taking this||
0362|179|N|medication. Keep all medical and lab appointments. Consult your||
0362|180|N|doctor for more details.||
0362|181|B|||
0362|182|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0362|183|D|remember. If you don't remember until the next day, skip the||
0362|184|D|missed dose. Take your next dose at the regular time. Do not||
0362|185|D|double the dose to catch up.||
0362|186|B|||
0362|187|R|STORAGE:  Store at room temperature away from light and moisture.||
0362|188|R|Do not store in the bathroom. Keep all medications away from||
0362|189|R|children and pets.||
0362|190|R|   Do not flush medications down the toilet or pour them into a||
0362|191|R|drain unless instructed to do so. Properly discard this product||
0362|192|R|when it is expired or no longer needed. Consult your pharmacist||
0362|193|R|or local waste disposal company.||
0362|194|B|||
0362|195|A|Information last revised February 2025.||
0362|196|A|Copyright(c) 2025 First Databank, Inc.||
0362|197|B|||
0364|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0364|002|Z|does NOT have all possible information about this product. This||
0364|003|Z|information does not assure that this product is safe, effective,||
0364|004|Z|or appropriate for you. This information is not individual||
0364|005|Z|medical advice and does not substitute for the advice of your||
0364|006|Z|health care professional. Always ask your health care||
0364|007|Z|professional for complete information about this product and your||
0364|008|Z|specific health needs.||
0364|009|B|||
0364|010|T|AZELAIC ACID GEL - TOPICAL||
0364|011|F|(ay-ze-LAY-ik AS-id)||
0364|012|B|||
0364|013|C|COMMON BRAND NAME(S): Finacea||
0364|014|B|||
0364|015|U|USES:  This medication is used to treat a certain skin condition||
0364|016|U|called rosacea. It helps to reduce the number of inflamed skin||
0364|017|U|lesions.||
0364|018|B|||
0364|019|H|HOW TO USE:  This medication is for use only on the skin.||
0364|020|H|   Clean the affected area with a mild soap or soap-free cleanser||
0364|021|H|and pat dry. Apply a thin layer of medication to the skin as||
0364|022|H|directed by your doctor, usually twice daily. Gently massage the||
0364|023|H|medication into the affected area. Wash your hands well after||
0364|024|H|application. Make-up may be applied after the medication has||
0364|025|H|dried.||
0364|026|H|   Avoid getting any of this medication in the eyes or inside the||
0364|027|H|nose or mouth. If it does get in your eyes, wash them right away||
0364|028|H|with plenty of water. Call your doctor if eye irritation lasts.||
0364|029|H|   Do not use large amounts or apply this product more often than||
0364|030|H|directed. Your condition will not clear faster, but the chance||
0364|031|H|for side effects may be increased. Improvement is usually seen||
0364|032|H|within 4 weeks. However, it may take several weeks of continued||
0364|033|H|use before the full effects of this medication are seen. Tell||
0364|034|H|your doctor if your symptoms do not get better or if they get||
0364|035|H|worse.||
0364|036|H|   Do not apply any dressing or covering over the treated area||
0364|037|H|unless directed by your doctor.||
0364|038|B|||
0364|039|S|SIDE EFFECTS:  Burning, stinging, tingling or itching skin may||
0364|040|S|occur during the first few weeks, but then subside as your body||
0364|041|S|adjusts to this medication. If any of these effects last or get||
0364|042|S|worse, notify your doctor or pharmacist promptly.||
0364|043|S|   Remember that this medication has been prescribed because your||
0364|044|S|doctor has judged that the benefit to you is greater than the||
0364|045|S|risk of side effects. Many people using this medication do not||
0364|046|S|have serious side effects.||
0364|047|S|   Tell your doctor right away if you have any serious side||
0364|048|S|effects, including: worsening of asthma symptoms (such as||
0364|049|S|increased trouble breathing, increased use of quick-relief||
0364|050|S|inhalers).||
0364|051|S|   This medication may rarely cause abnormal changes in skin||
0364|052|S|color (hypopigmentation). Dark-skinned individuals may notice a||
0364|053|S|lightening in skin color. Consult your doctor or pharmacist for||
0364|054|S|advice and report these changes if they occur.||
0364|055|S|   A very serious allergic reaction to this drug is rare.||
0364|056|S|However, get medical help right away if you notice any symptoms||
0364|057|S|of a serious allergic reaction, including: rash, itching/swelling||
0364|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0364|059|S|breathing.||
0364|060|S|   This is not a complete list of possible side effects. If you||
0364|061|S|notice other effects not listed above, contact your doctor or||
0364|062|S|pharmacist.||
0364|063|S|   In the US -||
0364|064|S|   Call your doctor for medical advice about side effects. You||
0364|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0364|066|S|www.fda.gov/medwatch.||
0364|067|S|   In Canada - Call your doctor for medical advice about side||
0364|068|S|effects. You may report side effects to Health Canada at||
0364|069|S|1-866-234-2345.||
0364|070|B|||
0364|071|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0364|072|P|pharmacist if you are allergic to it; or if you have any other||
0364|073|P|allergies. This product may contain inactive ingredients (such as||
0364|074|P|propylene glycol), which can cause allergic reactions or other||
0364|075|P|problems. Talk to your pharmacist for more details.||
0364|076|P|   Before using this medication, tell your doctor or pharmacist||
0364|077|P|your medical history, especially of: asthma.||
0364|078|P|   Avoid any foods or liquids that may bring on redness, flushing||
0364|079|P|or blushing of the skin (such as spicy foods, alcohol, hot||
0364|080|P|drinks).||
0364|081|P|   Before having surgery, tell your doctor or dentist about all||
0364|082|P|the products you use (including prescription drugs,||
0364|083|P|nonprescription drugs, and herbal products).||
0364|084|P|   During pregnancy, this medication should be used only when||
0364|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
0364|086|P|   This medication may pass into breast milk. Consult your doctor||
0364|087|P|before breastfeeding.||
0364|088|B|||
0364|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0364|090|I|medications work or increase your risk for serious side effects.||
0364|091|I|This document does not contain all possible drug interactions.||
0364|092|I|Keep a list of all the products you use (including||
0364|093|I|prescription/nonprescription drugs and herbal products) and share||
0364|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
0364|095|I|the dosage of any medicines without your doctor's approval.||
0364|096|I|   Avoid use of skin care products that can cause further||
0364|097|I|irritation (such as cleansers that contain alcohol, tinctures,||
0364|098|I|astringents, abrasives and peeling agents). Consult your doctor||
0364|099|I|or pharmacist for details.||
0364|100|B|||
0364|101|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0364|102|O|has overdosed and has serious symptoms such as passing out or||
0364|103|O|trouble breathing, call 911. Otherwise, call a poison control||
0364|104|O|center right away. US residents can call 1-800-222-1222. Canada||
0364|105|O|residents can call 1-844-764-7669.||
0364|106|B|||
0364|107|N|NOTES:  Do not share this medication with others.||
0364|108|B|||
0364|109|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0364|110|D|If it is near the time of the next dose, skip the missed dose.||
0364|111|D|Use your next dose at the regular time. Do not double the dose to||
0364|112|D|catch up.||
0364|113|B|||
0364|114|R|STORAGE:  Store at room temperature. Keep all medications away||
0364|115|R|from children and pets.||
0364|116|R|   Do not flush medications down the toilet or pour them into a||
0364|117|R|drain unless instructed to do so. Properly discard this product||
0364|118|R|when it is expired or no longer needed. Consult your pharmacist||
0364|119|R|or local waste disposal company.||
0364|120|B|||
0364|121|A|Information last revised November 2024.||
0364|122|A|Copyright(c) 2025 First Databank, Inc.||
0364|123|B|||
0365|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0365|002|Z|does NOT have all possible information about this product. This||
0365|003|Z|information does not assure that this product is safe, effective,||
0365|004|Z|or appropriate for you. This information is not individual||
0365|005|Z|medical advice and does not substitute for the advice of your||
0365|006|Z|health care professional. Always ask your health care||
0365|007|Z|professional for complete information about this product and your||
0365|008|Z|specific health needs.||
0365|009|B|||
0365|010|T|CYCLOSPORINE - OPHTHALMIC||
0365|011|F|(SYE-kloe-SPOR-in)||
0365|012|B|||
0365|013|C|COMMON BRAND NAME(S):  Restasis, Cequa, Vevye||
0365|014|B|||
0365|015|U|USES:  Cyclosporine eye drops are used to treat a certain type of||
0365|016|U|dry eyes. They work by increasing the amount of tears you make.||
0365|017|B|||
0365|018|H|HOW TO USE:  Read the Instructions for Use if available from your||
0365|019|H|pharmacist before you start using cyclosporine and each time you||
0365|020|H|get a refill. If you have any questions, ask your doctor or||
0365|021|H|pharmacist.||
0365|022|H|   Use this medication in the affected eye(s) as directed by your||
0365|023|H|doctor, usually twice a day (about 12 hours apart).||
0365|024|H|   To apply eye drops, wash hands first. To avoid contamination,||
0365|025|H|do not touch the dropper tip or let it touch your eye or any||
0365|026|H|other surface.||
0365|027|H|   There are different brands of this medication available. Some||
0365|028|H|brands should be mixed before use. If your brand does not need to||
0365|029|H|be mixed before use, the liquid is clear and colorless. If your||
0365|030|H|brand should be mixed, evenly mix the eye drops by turning the||
0365|031|H|vial upside down a few times before using your dose. The mixed||
0365|032|H|drops should look milky and white. Ask your doctor or pharmacist||
0365|033|H|if you have any questions about your brand.||
0365|034|H|   If you are wearing contact lenses, remove them before using||
0365|035|H|eye drops. Wait at least 15 minutes before replacing your contact||
0365|036|H|lenses. Tilt your head back, look upward, and pull down the lower||
0365|037|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0365|038|H|and place one drop into the pouch. Look downward, gently close||
0365|039|H|your eyes, and place one finger at the corner of your eye (near||
0365|040|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
0365|041|H|opening your eyes. This will prevent the medication from draining||
0365|042|H|out. Try not to blink or rub your eye. If directed to use this||
0365|043|H|medication in both eyes, repeat these steps for your other eye.||
0365|044|H|Do not rinse the dropper. Replace the dropper cap after each use.||
0365|045|H|   If you are using another kind of eye medication (such as drops||
0365|046|H|or ointments), wait at least 15 minutes before applying other||
0365|047|H|medications. Use eye drops before eye ointments to allow the||
0365|048|H|drops to enter the eye.||
0365|049|H|   Wait several minutes for your vision to clear before driving||
0365|050|H|or operating machinery.||
0365|051|H|   Use this medication regularly to get the most benefit from it.||
0365|052|H|To help you remember, use it at the same times each day.||
0365|053|H|   If you are using the single-use form of this medication, throw||
0365|054|H|away the opened vial after use. Do not save for later use.||
0365|055|H|   Tell your doctor if your condition gets worse.||
0365|056|B|||
0365|057|S|SIDE EFFECTS:  Eye discomfort/redness/itching, feeling as if||
0365|058|S|something is in the eye, or temporary blurred vision may occur.||
0365|059|S|If any of these effects last or get worse, tell your doctor or||
0365|060|S|pharmacist promptly.||
0365|061|S|   Remember that this medication has been prescribed because your||
0365|062|S|doctor has judged that the benefit to you is greater than the||
0365|063|S|risk of side effects. Many people using this medication do not||
0365|064|S|have serious side effects.||
0365|065|S|   A very serious allergic reaction to this drug is rare.||
0365|066|S|However, get medical help right away if you notice any symptoms||
0365|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0365|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0365|069|S|breathing.||
0365|070|S|   This is not a complete list of possible side effects. If you||
0365|071|S|notice other effects not listed above, contact your doctor or||
0365|072|S|pharmacist.||
0365|073|S|   In the US -||
0365|074|S|   Call your doctor for medical advice about side effects. You||
0365|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0365|076|S|www.fda.gov/medwatch.||
0365|077|S|   In Canada - Call your doctor for medical advice about side||
0365|078|S|effects. You may report side effects to Health Canada at||
0365|079|S|1-866-234-2345.||
0365|080|B|||
0365|081|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0365|082|P|pharmacist if you are allergic to it; or if you have any other||
0365|083|P|allergies. This product may contain inactive ingredients, which||
0365|084|P|can cause allergic reactions or other problems. Talk to your||
0365|085|P|pharmacist for more details.||
0365|086|P|   Before using this medication, tell your doctor or pharmacist||
0365|087|P|your medical history, especially of: current/recent eye||
0365|088|P|infection.||
0365|089|P|   After you apply this drug, your vision may become temporarily||
0365|090|P|blurred. Do not drive, use machinery, or do anything that needs||
0365|091|P|clear vision until you can do it safely.||
0365|092|P|   During pregnancy, this medication should be used only when||
0365|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
0365|094|P|   It is unknown if this drug passes into breast milk. Consult||
0365|095|P|your doctor before breastfeeding.||
0365|096|B|||
0365|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0365|098|I|medications work or increase your risk for serious side effects.||
0365|099|I|This document does not contain all possible drug interactions.||
0365|100|I|Keep a list of all the products you use (including||
0365|101|I|prescription/nonprescription drugs and herbal products) and share||
0365|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
0365|103|I|the dosage of any medicines without your doctor's approval.||
0365|104|B|||
0365|105|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0365|106|O|has overdosed and has serious symptoms such as passing out or||
0365|107|O|trouble breathing, call 911. Otherwise, call a poison control||
0365|108|O|center right away. US residents can call 1-800-222-1222. Canada||
0365|109|O|residents can call 1-844-764-7669.||
0365|110|B|||
0365|111|N|NOTES:  Do not share this medication with others.||
0365|112|B|||
0365|113|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0365|114|D|If it is near the time of the next dose, skip the missed dose.||
0365|115|D|Use your next dose at the regular time. Do not double the dose to||
0365|116|D|catch up.||
0365|117|B|||
0365|118|R|STORAGE:  Different brands of this medication have different||
0365|119|R|storage needs. Check the product package for instructions on how||
0365|120|R|to store your brand, or ask your pharmacist. Keep all medications||
0365|121|R|away from children and pets.||
0365|122|R|   Do not flush medications down the toilet or pour them into a||
0365|123|R|drain unless instructed to do so. Properly discard this product||
0365|124|R|when it is expired or no longer needed. Consult your pharmacist||
0365|125|R|or local waste disposal company.||
0365|126|B|||
0365|127|A|Information last revised July 2025.||
0365|128|A|Copyright(c) 2025 First Databank, Inc.||
0365|129|B|||
0366|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0366|002|Z|does NOT have all possible information about this product. This||
0366|003|Z|information does not assure that this product is safe, effective,||
0366|004|Z|or appropriate for you. This information is not individual||
0366|005|Z|medical advice and does not substitute for the advice of your||
0366|006|Z|health care professional. Always ask your health care||
0366|007|Z|professional for complete information about this product and your||
0366|008|Z|specific health needs.||
0366|009|B|||
0366|010|T|ENFUVIRTIDE - INJECTION||
0366|011|F|(en-FUE-vir-tide)||
0366|012|B|||
0366|013|C|COMMON BRAND NAME(S): Fuzeon||
0366|014|B|||
0366|015|U|USES:  This drug is used with other HIV medications to help||
0366|016|U|control HIV infection. It helps to decrease the amount of HIV in||
0366|017|U|your body so your immune system can work better. This lowers your||
0366|018|U|chance of getting HIV complications (such as new infections,||
0366|019|U|cancer) and improves your quality of life.||
0366|020|U|   Enfuvirtide is not a cure for HIV infection. To decrease your||
0366|021|U|risk of spreading HIV disease to others, continue to take all HIV||
0366|022|U|medications exactly as prescribed by your doctor. Use an||
0366|023|U|effective barrier method (latex or polyurethane condoms/dental||
0366|024|U|dams) during sexual activity as directed by your doctor. Do not||
0366|025|U|share personal items (such as needles/syringes, toothbrushes, and||
0366|026|U|razors) that may have contacted blood or other body fluids.||
0366|027|U|Consult your doctor or pharmacist for more details.||
0366|028|B|||
0366|029|V|OTHER USES:  This section contains uses of this drug that are not||
0366|030|V|listed in the approved professional labeling for the drug but||
0366|031|V|that may be prescribed by your health care professional. Use this||
0366|032|V|drug for a condition that is listed in this section only if it||
0366|033|V|has been so prescribed by your health care professional.||
0366|034|V|   This product may also be used to lessen the risk of HIV||
0366|035|V|infection after contact with the virus (for example, due to a||
0366|036|V|needle stick). Ask your doctor for more details.||
0366|037|B|||
0366|038|H|HOW TO USE:  Read the Patient Information Leaflet and||
0366|039|H|Instructions for Use if available from your pharmacist before you||
0366|040|H|start using enfuvirtide and each time you get a refill. Ask your||
0366|041|H|health care professional how to prepare and use this medication.||
0366|042|H|If you have any questions, ask your doctor or pharmacist.||
0366|043|H|   Inject this medication under the skin as directed by your||
0366|044|H|doctor, usually twice daily. The injection is given in the upper||
0366|045|H|arm, thigh, or abdomen. Do not inject into the buttock or near||
0366|046|H|the elbow, knee or groin. Children's dosage is based on weight.||
0366|047|H|   Before using, check this product for particles or||
0366|048|H|discoloration. If either is present, do not use the liquid.||
0366|049|H|Before injecting each dose, clean the skin you are going to||
0366|050|H|inject into (the injection site) with rubbing alcohol. Change the||
0366|051|H|injection site each time to lessen injury under the skin. Do not||
0366|052|H|inject in or near bumps from past injections or into moles,||
0366|053|H|scars, bruises, tattoos, burn areas, or your belly button. To||
0366|054|H|lessen bruising, do not rub the injection site after a shot.||
0366|055|H|Learn how to store and discard medical supplies safely.||
0366|056|H|   It is very important to keep using this medication (and other||
0366|057|H|anti-HIV medications) exactly as prescribed by your doctor. Do||
0366|058|H|not skip any doses.||
0366|059|H|   For the best effect, use this medication at evenly spaced||
0366|060|H|times. To help you remember, use this medication at the same||
0366|061|H|times every day.||
0366|062|B|||
0366|063|S|SIDE EFFECTS:  Pain, redness, itching, bruising, hardened skin,||
0366|064|S|or bumps at the injection site may occur. These types of||
0366|065|S|reactions are common and may last up to 7 days. Runny nose may||
0366|066|S|also occur. If any of these effects last or get worse, tell your||
0366|067|S|doctor or pharmacist promptly.||
0366|068|S|   Remember that this medication has been prescribed because your||
0366|069|S|doctor has judged that the benefit to you is greater than the||
0366|070|S|risk of side effects. Many people using this medication do not||
0366|071|S|have serious side effects.||
0366|072|S|   As your immune system gets stronger, it can begin to fight off||
0366|073|S|infections you already had, possibly causing disease symptoms to||
0366|074|S|come back. You could also have symptoms if your immune system||
0366|075|S|becomes overactive. This reaction may happen at any time (soon||
0366|076|S|after starting HIV treatment or many months later). Tell your||
0366|077|S|doctor right away if you have any serious symptoms, including:||
0366|078|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
0366|079|S|that doesn't go away, headaches that are severe or don't go away,||
0366|080|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
0366|081|S|changes, signs of infection (such as sore throat that doesn't go||
0366|082|S|away, fever, chills, swollen lymph nodes, non-healing skin||
0366|083|S|sores), signs of an overactive thyroid (such as irritability,||
0366|084|S|nervousness, heat intolerance, fast/pounding/irregular||
0366|085|S|heartbeat), signs of liver disease (such as nausea/vomiting that||
0366|086|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
0366|087|S|eyes/skin, dark urine).||
0366|088|S|   Tell your doctor right away if you have any serious side||
0366|089|S|effects, including: anxiety, numbness/tingling/shooting nerve||
0366|090|S|pain near injection site, signs of injection site infection (such||
0366|091|S|as pain and redness that don't go away, oozing, warmth),||
0366|092|S|abdominal pain, loss of appetite.||
0366|093|S|   A very serious allergic reaction to this drug is rare.||
0366|094|S|However, get medical help right away if you notice any symptoms||
0366|095|S|of a serious allergic reaction, including: rash, itching/swelling||
0366|096|S|(especially of the face/tongue/throat), dizziness, trouble||
0366|097|S|breathing.||
0366|098|S|   This is not a complete list of possible side effects. If you||
0366|099|S|notice other effects not listed above, contact your doctor or||
0366|100|S|pharmacist.||
0366|101|S|   In the US -||
0366|102|S|   Call your doctor for medical advice about side effects. You||
0366|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0366|104|S|www.fda.gov/medwatch.||
0366|105|S|   In Canada - Call your doctor for medical advice about side||
0366|106|S|effects. You may report side effects to Health Canada at||
0366|107|S|1-866-234-2345.||
0366|108|B|||
0366|109|P|PRECAUTIONS:  Before using enfuvirtide, tell your doctor or||
0366|110|P|pharmacist if you are allergic to it; or if you have any other||
0366|111|P|allergies. This product may contain inactive ingredients, which||
0366|112|P|can cause allergic reactions or other problems. Talk to your||
0366|113|P|pharmacist for more details.||
0366|114|P|   Before using this medication, tell your doctor or pharmacist||
0366|115|P|your medical history, especially of: bleeding problems (such as||
0366|116|P|hemophilia, coagulopathy), smoking, IV drug abuse, lung disease.||
0366|117|P|   Before having surgery, tell your doctor or dentist about all||
0366|118|P|the products you use (including prescription drugs,||
0366|119|P|nonprescription drugs, and herbal products).||
0366|120|P|   During pregnancy, this medication should be used only when||
0366|121|P|clearly needed. Treatment can lower the risk of passing HIV||
0366|122|P|infection to your baby, and enfuvirtide may be part of that||
0366|123|P|treatment. Discuss the risks and benefits with your doctor.||
0366|124|P|   It is unknown if this medication passes into breast milk.||
0366|125|P|Because breast milk may transmit HIV, consult your doctor before||
0366|126|P|breastfeeding.||
0366|127|B|||
0366|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0366|129|I|medications work or increase your risk for serious side effects.||
0366|130|I|This document does not contain all possible drug interactions.||
0366|131|I|Keep a list of all the products you use (including||
0366|132|I|prescription/nonprescription drugs and herbal products) and share||
0366|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
0366|134|I|the dosage of any medicines without your doctor's approval.||
0366|135|I|   Some products that may interact with this drug include: "blood||
0366|136|I|thinners" (such as warfarin, heparin, enoxaparin), orlistat.||
0366|137|B|||
0366|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0366|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0366|140|O|poison control center right away. US residents can call||
0366|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0366|142|B|||
0366|143|N|NOTES:  Do not share this medication with others.||
0366|144|N|   Lab and/or medical tests (such as liver function) should be||
0366|145|N|done while you are using this medication. Keep all medical and||
0366|146|N|lab appointments. Consult your doctor for more details.||
0366|147|B|||
0366|148|D|MISSED DOSE:  It is important to get each dose of this medication||
0366|149|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0366|150|D|right away for a new dosing schedule. Do not double the dose to||
0366|151|D|catch up.||
0366|152|B|||
0366|153|R|STORAGE:  Before mixing, store the dry powder and mixing solution||
0366|154|R|at room temperature. Once mixed, store the medication in the||
0366|155|R|refrigerator and use within 24 hours. Keep all medications away||
0366|156|R|from children and pets.||
0366|157|R|   Do not flush medications down the toilet or pour them into a||
0366|158|R|drain unless instructed to do so. Properly discard this product||
0366|159|R|when it is expired or no longer needed. Consult your pharmacist||
0366|160|R|or local waste disposal company.||
0366|161|B|||
0366|162|A|Information last revised April 2025.||
0366|163|A|Copyright(c) 2025 First Databank, Inc.||
0366|164|B|||
0367|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0367|002|Z|does NOT have all possible information about this product. This||
0367|003|Z|information does not assure that this product is safe, effective,||
0367|004|Z|or appropriate for you. This information is not individual||
0367|005|Z|medical advice and does not substitute for the advice of your||
0367|006|Z|health care professional. Always ask your health care||
0367|007|Z|professional for complete information about this product and your||
0367|008|Z|specific health needs.||
0367|009|B|||
0367|010|T|ALPRAZOLAM EXTENDED-RELEASE - ORAL||
0367|011|F|(al-PRA-zoe-lam)||
0367|012|B|||
0367|013|C|COMMON BRAND NAME(S): Xanax XR||
0367|014|B|||
0367|015|W|WARNING:  Alprazolam has a risk for abuse and addiction, which||
0367|016|W|can lead to overdose and death. Taking this medication with||
0367|017|W|alcohol or other drugs that can cause drowsiness or breathing||
0367|018|W|problems (especially opioid medications such as codeine,||
0367|019|W|hydrocodone) may cause very serious side effects, including||
0367|020|W|death. To lower your risk, your doctor should have you take the||
0367|021|W|smallest dose of alprazolam that works, and take it for the||
0367|022|W|shortest possible time. Be sure you know how to take alprazolam||
0367|023|W|and what other drugs you should avoid taking with it. See also||
0367|024|W|Drug Interactions section. Get medical help right away if any of||
0367|025|W|these very serious side effects occur: slow/shallow breathing,||
0367|026|W|unusual lightheadedness, severe drowsiness/dizziness, difficulty||
0367|027|W|waking up.||
0367|028|W|   Suddenly stopping this medication may cause serious (possibly||
0367|029|W|fatal) withdrawal, especially if you have used it for a long time||
0367|030|W|or in high doses. To prevent withdrawal, your doctor may lower||
0367|031|W|your dose slowly. Tell your doctor or pharmacist right away if||
0367|032|W|you have any withdrawal symptoms such as headaches, trouble||
0367|033|W|sleeping, restlessness, hallucinations/confusion, depression,||
0367|034|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
0367|035|W|to months.||
0367|036|B|||
0367|037|U|USES:  This medication is used to treat the panic and anxiety||
0367|038|U|symptoms associated with panic disorder. Alprazolam belongs to a||
0367|039|U|class of medications called benzodiazepines which act on the||
0367|040|U|brain and nerves (central nervous system) to produce a calming||
0367|041|U|effect. It works by enhancing the effects of a certain natural||
0367|042|U|chemical in the body (GABA).||
0367|043|B|||
0367|044|H|HOW TO USE:  See also Warning section.||
0367|045|H|   Read the Medication Guide provided by your pharmacist before||
0367|046|H|you start taking alprazolam and each time you get a refill. If||
0367|047|H|you have any questions, ask your doctor or pharmacist.||
0367|048|H|   Take this medication by mouth as directed by your doctor,||
0367|049|H|usually once daily in the morning. Do not take with a high-fat||
0367|050|H|meal because doing so can increase the risk of side effects.||
0367|051|H|Swallow the tablets whole. Do not crush or chew the tablets.||
0367|052|H|Doing so can release all of the drug at once, increasing the risk||
0367|053|H|of side effects. The dosage is based on your medical condition,||
0367|054|H|age, and response to treatment. Your dose may be gradually||
0367|055|H|increased until the drug starts working well. Follow your||
0367|056|H|doctor's instructions closely to reduce the risk of side effects.||
0367|057|H|   Though it helps many people, this medication may sometimes||
0367|058|H|cause addiction. This risk may be higher if you have a substance||
0367|059|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0367|060|H|Take this medication exactly as prescribed to lower the risk of||
0367|061|H|addiction. Ask your doctor or pharmacist for more details.||
0367|062|H|   When this medication is used for a long time, it may not work||
0367|063|H|as well. Talk with your doctor if this medication stops working||
0367|064|H|well.||
0367|065|H|   Tell your doctor if your condition lasts or gets worse.||
0367|066|B|||
0367|067|S|SIDE EFFECTS:  See also Warning section.||
0367|068|S|   Drowsiness, dizziness, increased saliva production, nausea,||
0367|069|S|constipation, or change in sex drive/ability may occur. If any of||
0367|070|S|these effects last or get worse, tell your doctor or pharmacist||
0367|071|S|promptly.||
0367|072|S|   To reduce the risk of dizziness and lightheadedness, get up||
0367|073|S|slowly when rising from a sitting or lying position.||
0367|074|S|   Remember that this medication has been prescribed because your||
0367|075|S|doctor has judged that the benefit to you is greater than the||
0367|076|S|risk of side effects. Many people using this medication do not||
0367|077|S|have serious side effects.||
0367|078|S|   Tell your doctor right away if you have any serious side||
0367|079|S|effects, including: mental/mood changes (such as hallucinations,||
0367|080|S|thoughts of suicide), trouble speaking, loss of coordination,||
0367|081|S|trouble walking, memory problems.||
0367|082|S|   Get medical help right away if you have any very serious side||
0367|083|S|effects, including: yellowing eyes/skin, seizures.||
0367|084|S|   A very serious allergic reaction to this drug is rare.||
0367|085|S|However, get medical help right away if you notice any symptoms||
0367|086|S|of a serious allergic reaction, including: rash, itching/swelling||
0367|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0367|088|S|breathing.||
0367|089|S|   This is not a complete list of possible side effects. If you||
0367|090|S|notice other effects not listed above, contact your doctor or||
0367|091|S|pharmacist.||
0367|092|S|   In the US -||
0367|093|S|   Call your doctor for medical advice about side effects. You||
0367|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0367|095|S|www.fda.gov/medwatch.||
0367|096|S|   In Canada - Call your doctor for medical advice about side||
0367|097|S|effects. You may report side effects to Health Canada at||
0367|098|S|1-866-234-2345.||
0367|099|B|||
0367|100|P|PRECAUTIONS:  Before taking alprazolam, tell your doctor or||
0367|101|P|pharmacist if you are allergic to it; or to other benzodiazepines||
0367|102|P|(such as diazepam, lorazepam); or if you have any other||
0367|103|P|allergies. This product may contain inactive ingredients, which||
0367|104|P|can cause allergic reactions or other problems. Talk to your||
0367|105|P|pharmacist for more details.||
0367|106|P|   Before using this medication, tell your doctor or pharmacist||
0367|107|P|your medical history, especially of: lung/breathing problems||
0367|108|P|(such as COPD, sleep apnea), liver disease, kidney disease,||
0367|109|P|personal or family history of a substance use disorder (such as||
0367|110|P|overuse of or addiction to drugs/alcohol), glaucoma.||
0367|111|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0367|112|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0367|113|P|machinery, or do anything that needs alertness until you can do||
0367|114|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0367|115|P|are using marijuana (cannabis).||
0367|116|P|   Before having surgery, tell your doctor or dentist about all||
0367|117|P|the products you use (including prescription drugs,||
0367|118|P|nonprescription drugs, and herbal products).||
0367|119|P|   Older adults may be more sensitive to the side effects of this||
0367|120|P|drug, especially loss of coordination and drowsiness. These side||
0367|121|P|effects can increase the risk of falling.||
0367|122|P|   Tell your doctor if you are pregnant or plan to become||
0367|123|P|pregnant. You should not become pregnant while using alprazolam.||
0367|124|P|Alprazolam may harm an unborn baby. Newborn babies of mothers who||
0367|125|P|use this medication late in pregnancy may have symptoms such as||
0367|126|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
0367|127|P|feeding. If you become pregnant, talk to your doctor right away||
0367|128|P|about the risks and benefits of this medication.||
0367|129|P|   This drug passes into breast milk and may have undesirable||
0367|130|P|effects on a nursing infant. Breastfeeding is not recommended||
0367|131|P|while using this drug. Consult your doctor before breastfeeding.||
0367|132|B|||
0367|133|I|DRUG INTERACTIONS:  See also Warning section.||
0367|134|I|   Drug interactions may change how your medications work or||
0367|135|I|increase your risk for serious side effects. This document does||
0367|136|I|not contain all possible drug interactions. Keep a list of all||
0367|137|I|the products you use (including prescription/nonprescription||
0367|138|I|drugs and herbal products) and share it with your doctor and||
0367|139|I|pharmacist. Do not start, stop, or change the dosage of any||
0367|140|I|medicines without your doctor's approval.||
0367|141|I|   Some products that may interact with this drug include: kava,||
0367|142|I|sodium oxybate.||
0367|143|I|   Other medications can affect the removal of alprazolam from||
0367|144|I|your body, which may affect how alprazolam works. Examples||
0367|145|I|include adagrasib, azole antifungals (such as itraconazole,||
0367|146|I|ketoconazole), cimetidine, certain anti-depressants (such as||
0367|147|I|fluoxetine, fluvoxamine, nefazodone), macrolide antibiotics (such||
0367|148|I|as erythromycin), rifamycins (such as rifabutin), St. John's||
0367|149|I|wort, drugs used to treat seizures (such as phenytoin), among||
0367|150|I|others.||
0367|151|I|   The risk of serious side effects (such as slow/shallow||
0367|152|I|breathing, severe drowsiness/dizziness) may be increased if this||
0367|153|I|medication is taken with other products that may also cause||
0367|154|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0367|155|I|if you are taking other products such as opioid pain or cough||
0367|156|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0367|157|I|(cannabis), other drugs for sleep or anxiety (such as diazepam,||
0367|158|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0367|159|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0367|160|I|diphenhydramine).||
0367|161|I|   Check the labels on all your medicines (such as allergy or||
0367|162|I|cough-and-cold products) because they may contain ingredients||
0367|163|I|that cause drowsiness. Ask your pharmacist about using those||
0367|164|I|products safely.||
0367|165|I|   Cigarette smoking decreases blood levels of this medication.||
0367|166|I|Tell your doctor if you smoke or if you have recently stopped||
0367|167|I|smoking.||
0367|168|B|||
0367|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0367|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0367|171|O|poison control center right away. US residents can call||
0367|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0367|173|O|Symptoms of overdose may include: severe drowsiness,||
0367|174|O|slowed/reduced reflexes, slowed breathing, loss of consciousness.||
0367|175|B|||
0367|176|N|NOTES:  Do not share this medication with others. Sharing it is||
0367|177|N|against the law.||
0367|178|N|   Lab and/or medical tests (such as liver function) should be||
0367|179|N|done while you are taking this medication. Keep all medical and||
0367|180|N|lab appointments. Consult your doctor for more details.||
0367|181|B|||
0367|182|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0367|183|D|remember. If it is near the time of the next dose, skip the||
0367|184|D|missed dose. Take your next dose at the regular time. Do not||
0367|185|D|double the dose to catch up.||
0367|186|B|||
0367|187|R|STORAGE:  Store at room temperature away from light and moisture.||
0367|188|R|Do not store in the bathroom. Keep all medications away from||
0367|189|R|children and pets.||
0367|190|R|   Do not flush medications down the toilet or pour them into a||
0367|191|R|drain unless instructed to do so. Properly discard this product||
0367|192|R|when it is expired or no longer needed. Consult your pharmacist||
0367|193|R|or local waste disposal company.||
0367|194|B|||
0367|195|A|Information last revised April 2025.||
0367|196|A|Copyright(c) 2025 First Databank, Inc.||
0367|197|B|||
0368|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0368|002|Z|does NOT have all possible information about this product. This||
0368|003|Z|information does not assure that this product is safe, effective,||
0368|004|Z|or appropriate for you. This information is not individual||
0368|005|Z|medical advice and does not substitute for the advice of your||
0368|006|Z|health care professional. Always ask your health care||
0368|007|Z|professional for complete information about this product and your||
0368|008|Z|specific health needs.||
0368|009|B|||
0368|010|T|IBUPROFEN CHEWABLE - ORAL||
0368|011|F|(EYE-bue-PROE-fen)||
0368|012|B|||
0368|013|C|COMMON BRAND NAME(S): Advil, Children's Advil, Motrin||
0368|014|B|||
0368|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0368|016|W|ibuprofen) may rarely increase the risk of a heart attack or||
0368|017|W|stroke. This effect can happen at any time while taking this drug||
0368|018|W|but is more likely if you take it for a long time. The risk may||
0368|019|W|be greater in older adults or if you have heart disease or||
0368|020|W|increased risk for heart disease (for example, due to smoking,||
0368|021|W|family history of heart disease, or conditions such as high blood||
0368|022|W|pressure or diabetes). Do not take this drug right before or||
0368|023|W|after heart bypass surgery (CABG).||
0368|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
0368|025|W|from the stomach or intestines. This effect can occur without||
0368|026|W|warning at any time while taking this drug. Older adults may be||
0368|027|W|at higher risk for this effect.||
0368|028|W|   Stop taking ibuprofen and get medical help right away if you||
0368|029|W|notice any of these rare but serious side effects:||
0368|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0368|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0368|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0368|033|W|side of the body, trouble speaking, sudden vision changes.||
0368|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0368|035|W|of taking this drug.||
0368|036|B|||
0368|037|U|USES:  Ibuprofen is used to relieve pain from various conditions||
0368|038|U|such as headache, dental pain, menstrual cramps, muscle aches, or||
0368|039|U|arthritis. It is also used to reduce fever and to relieve minor||
0368|040|U|aches and pain due to the common cold or flu. Ibuprofen is a||
0368|041|U|nonsteroidal anti-inflammatory drug (NSAID). It works by blocking||
0368|042|U|your body's production of certain natural substances that cause||
0368|043|U|inflammation. This effect helps to decrease swelling, pain, or||
0368|044|U|fever.||
0368|045|U|   If you are treating a chronic condition such as arthritis, ask||
0368|046|U|your doctor about non-drug treatments and/or using other||
0368|047|U|medications to treat your pain. See also Warning section.||
0368|048|U|   This form of ibuprofen is intended for use by children. Do not||
0368|049|U|give this medication to a child younger than 2 years unless||
0368|050|U|directed by the doctor.||
0368|051|U|   Check the ingredients on the label even if you have used the||
0368|052|U|product before. The manufacturer may have changed the||
0368|053|U|ingredients. Also, products with similar names may contain||
0368|054|U|different ingredients meant for different purposes. Taking the||
0368|055|U|wrong product could harm you.||
0368|056|B|||
0368|057|H|HOW TO USE:  Read and follow all directions on the product||
0368|058|H|package before using this medication. If you have any questions,||
0368|059|H|ask your doctor or pharmacist.||
0368|060|H|   Take this medication by mouth as directed by your doctor or||
0368|061|H|the package label, usually every 6 to 8 hours as needed. Chew||
0368|062|H|thoroughly and then swallow this medication. If you have stomach||
0368|063|H|upset while taking this medication, take it with food, milk, or||
0368|064|H|an antacid.||
0368|065|H|   The dosage is based on your medical condition and response to||
0368|066|H|treatment. To reduce your risk of stomach bleeding and other side||
0368|067|H|effects, take this medication at the lowest effective dose for||
0368|068|H|the shortest possible time. Do not increase your dose or take||
0368|069|H|this drug more often than directed by your doctor or the package||
0368|070|H|label.||
0368|071|H|   Children's dosage is based on weight. Read the package||
0368|072|H|directions to find the proper dose for your child's weight.||
0368|073|H|Consult the pharmacist or doctor if you have questions or if you||
0368|074|H|need help choosing a nonprescription product.||
0368|075|H|   If you are using this drug "as needed" (not on a regular||
0368|076|H|schedule), remember that pain medications work best if they are||
0368|077|H|used as the first signs of pain occur. If you wait until the pain||
0368|078|H|has worsened, the medication may not work as well.||
0368|079|H|   If your condition lasts or gets worse, or if you think you may||
0368|080|H|have a serious medical problem, get medical help right away. If||
0368|081|H|you are using the nonprescription product to treat yourself or a||
0368|082|H|child for fever or pain, consult the doctor right away if fever||
0368|083|H|gets worse or lasts more than 3 days, or if pain gets worse or||
0368|084|H|lasts more than 10 days.||
0368|085|B|||
0368|086|S|SIDE EFFECTS:  See also Warning section.||
0368|087|S|   Upset stomach, nausea, vomiting, headache, diarrhea,||
0368|088|S|constipation, dizziness, or drowsiness may occur. If any of these||
0368|089|S|effects last or get worse, tell your doctor or pharmacist||
0368|090|S|promptly.||
0368|091|S|   If your doctor has directed you to use this medication,||
0368|092|S|remember that your doctor has judged that the benefit to you is||
0368|093|S|greater than the risk of side effects. Many people using this||
0368|094|S|medication do not have serious side effects.||
0368|095|S|   This medication may raise your blood pressure. Check your||
0368|096|S|blood pressure regularly and tell your doctor if the results are||
0368|097|S|high.||
0368|098|S|   Tell your doctor right away if any of these serious side||
0368|099|S|effects occur: easy bruising/bleeding, hearing changes (such as||
0368|100|S|ringing in the ears), mental/mood changes, unexplained stiff||
0368|101|S|neck, signs of kidney problems (such as change in the amount of||
0368|102|S|urine), vision changes, symptoms of heart failure (such as||
0368|103|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
0368|104|S|gain).||
0368|105|S|   This drug may rarely cause serious (possibly fatal) liver||
0368|106|S|disease. Get medical help right away if you have any symptoms of||
0368|107|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0368|108|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
0368|109|S|eyes/skin.||
0368|110|S|   A very serious allergic reaction to this drug is rare.||
0368|111|S|However, get medical help right away if you notice any symptoms||
0368|112|S|of a serious allergic reaction, including: fever, swollen lymph||
0368|113|S|nodes, rash, itching/swelling (especially of the||
0368|114|S|face/tongue/throat), severe dizziness, trouble breathing.||
0368|115|S|   This is not a complete list of possible side effects. If you||
0368|116|S|notice other effects not listed above, contact your doctor or||
0368|117|S|pharmacist.||
0368|118|S|   In the US -||
0368|119|S|   Call your doctor for medical advice about side effects. You||
0368|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0368|121|S|www.fda.gov/medwatch.||
0368|122|S|   In Canada - Call your doctor for medical advice about side||
0368|123|S|effects. You may report side effects to Health Canada at||
0368|124|S|1-866-234-2345.||
0368|125|B|||
0368|126|P|PRECAUTIONS:  Before using ibuprofen, tell the doctor or||
0368|127|P|pharmacist if you are allergic to it; or to aspirin or other||
0368|128|P|NSAIDs (such as naproxen, celecoxib); or if you have any other||
0368|129|P|allergies. This product may contain inactive ingredients, which||
0368|130|P|can cause allergic reactions or other problems. Talk to your||
0368|131|P|pharmacist for more details.||
0368|132|P|   Before using this medication, tell your doctor or pharmacist||
0368|133|P|your medical history, especially of: asthma (including a history||
0368|134|P|of worsening breathing after taking aspirin or other NSAIDs),||
0368|135|P|blood disorders (such as anemia, bleeding/clotting problems),||
0368|136|P|growths in the nose (nasal polyps), heart disease (such as||
0368|137|P|previous heart attack), high blood pressure, liver disease,||
0368|138|P|stroke, throat/stomach/intestinal problems (such as bleeding,||
0368|139|P|heartburn, ulcers).||
0368|140|P|   Kidney problems can sometimes occur with the use of NSAID||
0368|141|P|medications, including ibuprofen. Problems are more likely to||
0368|142|P|occur if you are dehydrated, have heart failure or kidney||
0368|143|P|disease, are an older adult, or if you take certain medications||
0368|144|P|(see also Drug Interactions section). Drink plenty of fluids as||
0368|145|P|directed by your doctor to prevent dehydration and tell your||
0368|146|P|doctor right away if you have a change in the amount of urine.||
0368|147|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0368|148|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0368|149|P|machinery, or do anything that needs alertness until you can do||
0368|150|P|it safely. Talk to your doctor if you are using marijuana||
0368|151|P|(cannabis).||
0368|152|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0368|153|P|and tobacco, especially when combined with this medicine, may||
0368|154|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0368|155|P|smoking. Consult your doctor or pharmacist for more information.||
0368|156|P|   This medication may make you more sensitive to the sun. Limit||
0368|157|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0368|158|P|sunscreen and wear protective clothing when outdoors. Tell your||
0368|159|P|doctor right away if you get sunburned or have skin||
0368|160|P|blisters/redness.||
0368|161|P|   This product may contain sugar and/or aspartame. Caution is||
0368|162|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
0368|163|P|condition that requires you to limit/avoid these substances in||
0368|164|P|your diet. Ask your doctor or pharmacist about using this product||
0368|165|P|safely.||
0368|166|P|   Before having surgery, tell your doctor or dentist about all||
0368|167|P|the products you use (including prescription drugs,||
0368|168|P|nonprescription drugs, and herbal products).||
0368|169|P|   Older adults may be at greater risk for stomach/intestinal||
0368|170|P|bleeding, kidney problems, heart attack, and stroke while using||
0368|171|P|this drug.||
0368|172|P|   Before using this medication, women of childbearing age should||
0368|173|P|talk with their doctor(s) about the benefits and risks. Tell your||
0368|174|P|doctor if you are pregnant or if you plan to become pregnant.||
0368|175|P|This medication may harm an unborn baby and cause problems with||
0368|176|P|normal labor/delivery. It is not recommended for use in pregnancy||
0368|177|P|from 20 weeks until delivery. If your doctor decides that you||
0368|178|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0368|179|P|you should use the lowest effective dose for the shortest||
0368|180|P|possible time. You should not use this medication after 30 weeks||
0368|181|P|of pregnancy.||
0368|182|P|   This medication passes into breast milk, but is unlikely to||
0368|183|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0368|184|B|||
0368|185|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0368|186|I|medications work or increase your risk for serious side effects.||
0368|187|I|This document does not contain all possible drug interactions.||
0368|188|I|Keep a list of all the products you use (including||
0368|189|I|prescription/nonprescription drugs and herbal products) and share||
0368|190|I|it with your doctor and pharmacist. Do not start, stop, or change||
0368|191|I|the dosage of any medicines without your doctor's approval.||
0368|192|I|   Some products that may interact with this drug include:||
0368|193|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
0368|194|I|angiotensin II receptor blockers (such as losartan, valsartan),||
0368|195|I|cidofovir, corticosteroids (such as prednisone), lithium, "water||
0368|196|I|pills" (diuretics such as furosemide).||
0368|197|I|   This medication may increase the risk of bleeding when taken||
0368|198|I|with other drugs that also may cause bleeding. Examples include||
0368|199|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0368|200|I|dabigatran/enoxaparin/warfarin, among others.||
0368|201|I|   Check all prescription and nonprescription medicine labels||
0368|202|I|carefully since many medications contain pain relievers/fever||
0368|203|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
0368|204|I|or naproxen). These drugs are similar to ibuprofen and may||
0368|205|I|increase your risk of side effects if taken together. However, if||
0368|206|I|your doctor has told you to take low-dose aspirin to prevent||
0368|207|I|heart attack or stroke (usually 81-162 milligrams a day), you||
0368|208|I|should keep taking the aspirin unless your doctor tells you not||
0368|209|I|to. Daily use of ibuprofen may decrease aspirin's ability to||
0368|210|I|prevent heart attack/stroke. Talk to your doctor about using a||
0368|211|I|different medication (such as acetaminophen) to treat pain/fever.||
0368|212|I|If you must take ibuprofen, talk to your doctor about taking||
0368|213|I|immediate-release aspirin (not enteric-coated/EC) while taking||
0368|214|I|ibuprofen. Take ibuprofen at least 8 hours before or at least 2||
0368|215|I|hours after your aspirin dose. Do not increase your daily dose of||
0368|216|I|aspirin or change the way you take aspirin/other medications||
0368|217|I|without your doctor's approval.||
0368|218|B|||
0368|219|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0368|220|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0368|221|O|poison control center right away. US residents can call||
0368|222|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0368|223|O|Symptoms of overdose may include: severe stomach pain, trouble||
0368|224|O|breathing, extreme drowsiness.||
0368|225|B|||
0368|226|N|NOTES:  Lab and/or medical tests (including blood pressure,||
0368|227|N|kidney function) may be done while you are taking this||
0368|228|N|medication. Keep all medical and lab appointments. Consult your||
0368|229|N|doctor for more details.||
0368|230|B|||
0368|231|D|MISSED DOSE:  If you are using this drug on a regular schedule||
0368|232|D|(not just "as needed") and you miss a dose, take it as soon as||
0368|233|D|you remember. If it is near the time of the next dose, skip the||
0368|234|D|missed dose. Take your next dose at the regular time. Do not||
0368|235|D|double the dose to catch up.||
0368|236|B|||
0368|237|R|STORAGE:  Store at room temperature away from light and moisture.||
0368|238|R|Do not store in the bathroom. Keep all medications away from||
0368|239|R|children and pets.||
0368|240|R|   Do not flush medications down the toilet or pour them into a||
0368|241|R|drain unless instructed to do so. Properly discard this product||
0368|242|R|when it is expired or no longer needed. Consult your pharmacist||
0368|243|R|or local waste disposal company.||
0368|244|B|||
0368|245|A|Information last revised August 2024.||
0368|246|A|Copyright(c) 2025 First Databank, Inc.||
0368|247|B|||
0369|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0369|002|Z|does NOT have all possible information about this product. This||
0369|003|Z|information does not assure that this product is safe, effective,||
0369|004|Z|or appropriate for you. This information is not individual||
0369|005|Z|medical advice and does not substitute for the advice of your||
0369|006|Z|health care professional. Always ask your health care||
0369|007|Z|professional for complete information about this product and your||
0369|008|Z|specific health needs.||
0369|009|B|||
0369|010|T|GEFITINIB - ORAL||
0369|011|F|(ge-FI-ti-nib)||
0369|012|B|||
0369|013|C|COMMON BRAND NAME(S): Iressa||
0369|014|B|||
0369|015|W|WARNING:  Gefitinib has rarely caused very serious (possibly||
0369|016|W|fatal) liver disease. Get medical help right away if you develop||
0369|017|W|symptoms of liver disease, including stomach/abdominal pain,||
0369|018|W|unusual tiredness, dark urine, yellowing eyes/skin.||
0369|019|W|   Gefitinib has also rarely caused very serious (possibly fatal)||
0369|020|W|tears in the wall of the stomach or intestines. Get medical help||
0369|021|W|right away if you develop stomach/abdominal pain, black/bloody||
0369|022|W|stools, or vomit that looks like coffee grounds.||
0369|023|B|||
0369|024|U|USES:  Gefitinib is used to treat lung cancer. It works by||
0369|025|U|slowing or stopping the growth of cancer cells. Gefitinib blocks||
0369|026|U|a certain protein (an enzyme called tyrosine kinase).||
0369|027|B|||
0369|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0369|029|H|from your pharmacist before you start taking gefitinib and each||
0369|030|H|time you get a refill. If you have any questions, ask your doctor||
0369|031|H|or pharmacist.||
0369|032|H|   Take gefitinib by mouth with or without food as directed by||
0369|033|H|your doctor, usually once daily.||
0369|034|H|   If you have trouble swallowing the tablet, you may place the||
0369|035|H|tablet in a glass of water (4 to 8 ounces/120 to 240||
0369|036|H|milliliters). Stir well for 15 minutes. Drink all of the mixture||
0369|037|H|right away. Rinse the cup with another 4 to 8 ounces (120 to 240||
0369|038|H|milliliters) of water and drink the rinse water to make sure you||
0369|039|H|get the full dose.||
0369|040|H|   Medications that reduce stomach acid (such as antacids, proton||
0369|041|H|pump inhibitors/PPIs, H2 blockers) may make gefitinib work less||
0369|042|H|well. If you take PPIs (such as lansoprazole, omeprazole), take||
0369|043|H|gefitinib 12 hours before or 12 hours after taking the PPI. If||
0369|044|H|you take antacids or H2 blockers (such as famotidine,||
0369|045|H|nizatidine), take gefitinib 6 hours before or 6 hours after||
0369|046|H|taking the antacid or H2 blocker.||
0369|047|H|   The dosage is based on your medical condition, response to||
0369|048|H|treatment, lab tests, and other medications you may be taking. Be||
0369|049|H|sure to tell your doctor and pharmacist about all the products||
0369|050|H|you use (including prescription drugs, nonprescription drugs, and||
0369|051|H|herbal products).||
0369|052|H|   Use this medication regularly to get the most benefit from it.||
0369|053|H|To help you remember, take it at the same time each day.||
0369|054|H|   Do not increase your dose or use this drug more often or for||
0369|055|H|longer than prescribed. Your condition will not improve any||
0369|056|H|faster, and your risk of side effects will increase.||
0369|057|B|||
0369|058|S|SIDE EFFECTS:  See also Warning section.||
0369|059|S|   Diarrhea, rash, acne, dry skin, nausea, vomiting, loss of||
0369|060|S|appetite, nail problems, hair loss, red/sore mouth or throat, or||
0369|061|S|unusual weakness may occur. If any of these effects last or get||
0369|062|S|worse, tell your doctor or pharmacist right away.||
0369|063|S|   Diarrhea is a common side effect. Drink plenty of fluids as||
0369|064|S|directed by your doctor to reduce your risk of dehydration. Your||
0369|065|S|doctor may prescribe anti-diarrhea medication to control your||
0369|066|S|symptoms. Tell your doctor right away if you develop diarrhea||
0369|067|S|that is severe or doesn't stop, or signs of dehydration (such as||
0369|068|S|extreme thirst, dizziness, decreased urination).||
0369|069|S|   Remember that this medication has been prescribed because your||
0369|070|S|doctor has judged that the benefit to you is greater than the||
0369|071|S|risk of side effects. Many people using this medication do not||
0369|072|S|have serious side effects.||
0369|073|S|   Tell your doctor right away if you have any serious side||
0369|074|S|effects, including: signs of kidney problems (such as change in||
0369|075|S|the amount of urine), unusual bleeding (coughing up blood, blood||
0369|076|S|in urine), eye irritation/pain, swelling of the ankles/feet.||
0369|077|S|   Gefitinib may cause rare (possibly fatal) lung disease||
0369|078|S|(interstitial lung disease-ILD). Tell your doctor right away if||
0369|079|S|you develop shortness of breath, cough, or fever.||
0369|080|S|   Gefitinib can commonly cause a rash that is usually not||
0369|081|S|serious. However, you may not be able to tell it apart from a||
0369|082|S|rare rash that could be a sign of a severe reaction. Get medical||
0369|083|S|help right away if you develop any rash.||
0369|084|S|   A very serious allergic reaction to this drug is rare.||
0369|085|S|However, get medical help right away if you notice any symptoms||
0369|086|S|of a serious allergic reaction, including: rash, itching/swelling||
0369|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0369|088|S|breathing.||
0369|089|S|   This is not a complete list of possible side effects. If you||
0369|090|S|notice other effects not listed above, contact your doctor or||
0369|091|S|pharmacist.||
0369|092|S|   In the US -||
0369|093|S|   Call your doctor for medical advice about side effects. You||
0369|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0369|095|S|www.fda.gov/medwatch.||
0369|096|S|   In Canada - Call your doctor for medical advice about side||
0369|097|S|effects. You may report side effects to Health Canada at||
0369|098|S|1-866-234-2345.||
0369|099|B|||
0369|100|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0369|101|P|pharmacist if you are allergic to it; or if you have any other||
0369|102|P|allergies. This product may contain inactive ingredients, which||
0369|103|P|can cause allergic reactions or other problems. Talk to your||
0369|104|P|pharmacist for more details.||
0369|105|P|   Before using this medication, tell your doctor or pharmacist||
0369|106|P|your medical history, especially of: lung disease (such as||
0369|107|P|pulmonary fibrosis), severe kidney disease, eye problems,||
0369|108|P|stomach/intestinal ulcers, other stomach/intestinal problems||
0369|109|P|(such as diverticulitis, blockage, bowel disease), smoking,||
0369|110|P|cancer that has spread to the bowels.||
0369|111|P|   Before having surgery, tell your doctor or dentist about all||
0369|112|P|the products you use (including prescription drugs,||
0369|113|P|nonprescription drugs, and herbal products).||
0369|114|P|   Tell your doctor if you are pregnant or plan to become||
0369|115|P|pregnant. You should not become pregnant while using gefitinib.||
0369|116|P|Gefitinib may harm an unborn baby. Ask about reliable forms of||
0369|117|P|birth control while using this medication and for 2 weeks after||
0369|118|P|the last dose. If you become pregnant, talk to your doctor right||
0369|119|P|away about the risks and benefits of this medication.||
0369|120|P|   It is unknown if gefitinib passes into breast milk. Because of||
0369|121|P|possible risk to the infant, breastfeeding is not recommended||
0369|122|P|while using this medication. Consult your doctor before||
0369|123|P|breastfeeding.||
0369|124|B|||
0369|125|I|DRUG INTERACTIONS:  See also How to Use section.||
0369|126|I|   Drug interactions may change how your medications work or||
0369|127|I|increase your risk for serious side effects. This document does||
0369|128|I|not contain all possible drug interactions. Keep a list of all||
0369|129|I|the products you use (including prescription/nonprescription||
0369|130|I|drugs and herbal products) and share it with your doctor and||
0369|131|I|pharmacist. Do not start, stop, or change the dosage of any||
0369|132|I|medicines without your doctor's approval.||
0369|133|I|   Some products that may interact with this drug are: "blood||
0369|134|I|thinners" (warfarin), vinorelbine, NSAIDs (such as ibuprofen,||
0369|135|I|naproxen), corticosteroids (such as prednisone).||
0369|136|B|||
0369|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0369|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0369|139|O|poison control center right away. US residents can call||
0369|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0369|141|O|Symptoms of overdose may include: diarrhea that is severe or||
0369|142|O|doesn't stop, severe skin rash.||
0369|143|B|||
0369|144|N|NOTES:  Do not share this medication with others.||
0369|145|N|   Lab and/or medical tests (such as kidney/liver function)||
0369|146|N|should be done while you are taking this medication. Keep all||
0369|147|N|medical and lab appointments. Consult your doctor for more||
0369|148|N|details.||
0369|149|B|||
0369|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0369|151|D|remember. If it is less than 12 hours before the next dose, skip||
0369|152|D|the missed dose. Take your next dose at the regular time. Do not||
0369|153|D|double the dose to catch up.||
0369|154|B|||
0369|155|R|STORAGE:  Store at room temperature away from light and moisture.||
0369|156|R|Do not store in the bathroom. Keep all medications away from||
0369|157|R|children and pets.||
0369|158|R|   Do not flush medications down the toilet or pour them into a||
0369|159|R|drain unless instructed to do so. Properly discard this product||
0369|160|R|when it is expired or no longer needed. Consult your pharmacist||
0369|161|R|or local waste disposal company.||
0369|162|B|||
0369|163|A|Information last revised June 2025.||
0369|164|A|Copyright(c) 2025 First Databank, Inc.||
0369|165|B|||
0370|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0370|002|Z|does NOT have all possible information about this product. This||
0370|003|Z|information does not assure that this product is safe, effective,||
0370|004|Z|or appropriate for you. This information is not individual||
0370|005|Z|medical advice and does not substitute for the advice of your||
0370|006|Z|health care professional. Always ask your health care||
0370|007|Z|professional for complete information about this product and your||
0370|008|Z|specific health needs.||
0370|009|B|||
0370|010|T|OMALIZUMAB - INJECTION||
0370|011|F|(OH-ma-LIZ-ue-mab)||
0370|012|B|||
0370|013|C|COMMON BRAND NAME(S): Xolair||
0370|014|B|||
0370|015|W|WARNING:  This medication can rarely cause a very serious||
0370|016|W|(sometimes fatal) allergic reaction. This reaction has occurred||
0370|017|W|after the first dose or after later doses, even more than one||
0370|018|W|year after starting treatment. The risk is greater if you have a||
0370|019|W|history of severe allergies to other medications or to foods.||
0370|020|W|Your health care professional will monitor you closely during||
0370|021|W|treatment for any signs of an allergic reaction. Get medical help||
0370|022|W|right away if you notice any symptoms of a serious allergic||
0370|023|W|reaction, including: itching/swelling (especially of the||
0370|024|W|face/tongue/throat), flushing, trouble breathing, severe||
0370|025|W|dizziness, fainting, or rash/hives.||
0370|026|W|   If you have had an allergic reaction to omalizumab, you must||
0370|027|W|never use omalizumab again.||
0370|028|B|||
0370|029|U|USES:  Omalizumab is used to control and prevent symptoms (such||
0370|030|U|as wheezing and shortness of breath) caused by asthma that is due||
0370|031|U|to year-round allergens. Controlling symptoms of asthma helps you||
0370|032|U|maintain your normal activities and cuts down on time lost from||
0370|033|U|work or school. Omalizumab may also be used to treat certain||
0370|034|U|growths in the nose (chronic rhinosinusitis with nasal polyps) or||
0370|035|U|to treat hives from an unknown cause (chronic spontaneous||
0370|036|U|urticaria-CSU).||
0370|037|U|   Omalizumab is also used in people with a certain type of food||
0370|038|U|allergy (IgE-mediated food allergy) while continuing to avoid||
0370|039|U|food allergens. It may help lower the risk of having serious||
0370|040|U|allergic reactions.||
0370|041|U|   This medication must be used regularly to be effective. It||
0370|042|U|does not work right away and should not be used as an emergency||
0370|043|U|treatment for serious allergic reactions or to relieve sudden||
0370|044|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
0370|045|U|inhaler (such as albuterol, salbutamol) as prescribed.||
0370|046|B|||
0370|047|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
0370|048|H|provided by your pharmacist before you start using omalizumab and||
0370|049|H|each time you get a refill. If you have any questions, ask your||
0370|050|H|doctor or pharmacist.||
0370|051|H|   Inject this medication under the skin as directed by your||
0370|052|H|doctor, usually every 2 or 4 weeks. The injection is given in the||
0370|053|H|upper arms, thighs, or abdomen (except for a 2-inch area around||
0370|054|H|your belly button). The first dose is given by a health care||
0370|055|H|professional and you will be monitored in case you have a severe||
0370|056|H|allergic reaction. Later doses may be given by a health care||
0370|057|H|professional or at home. The dosage and treatment schedule are||
0370|058|H|based on your medical condition and response to treatment. For||
0370|059|H|the treatment of asthma, nasal polyps, and food allergies, the||
0370|060|H|dosage is also based on your weight and labs.||
0370|061|H|   If you are using this medication at home, learn all||
0370|062|H|preparation and usage instructions from your health care||
0370|063|H|professional. For a more comfortable injection, take the||
0370|064|H|medication out of the refrigerator at least 30 to 45 minutes||
0370|065|H|before you inject it to allow it to reach room temperature. Do||
0370|066|H|not warm up this medication in any other way (for example, do not||
0370|067|H|heat it in the microwave or place it in hot water). Before using,||
0370|068|H|check this product for particles or discoloration. If either is||
0370|069|H|present, do not use the liquid. Before injecting each dose, clean||
0370|070|H|the skin you are going to inject into (the injection site) with||
0370|071|H|rubbing alcohol. Change the injection site each time to lessen||
0370|072|H|injury under the skin. Do not inject into skin that is tender,||
0370|073|H|bruised, red, hard, or damaged, or into moles or scars. To lessen||
0370|074|H|bruising, do not rub the injection site after a shot. Learn how||
0370|075|H|to store and discard medical supplies safely.||
0370|076|H|   Use this medication regularly to get the most benefit from it.||
0370|077|H|To help you remember, mark your calendar with a reminder.||
0370|078|H|   Get medical help right away if your asthma symptoms worsen or||
0370|079|H|if you are using your quick-relief inhaler more than usual or||
0370|080|H|more often than prescribed.||
0370|081|B|||
0370|082|S|SIDE EFFECTS:  See also Warning section.||
0370|083|S|   Itching, bruising, redness, pain, or swelling at the injection||
0370|084|S|site may occur. Headache may also occur. If any of these effects||
0370|085|S|last or get worse, tell your doctor or pharmacist promptly.||
0370|086|S|   Remember that this medication has been prescribed because your||
0370|087|S|doctor has judged that the benefit to you is greater than the||
0370|088|S|risk of side effects. Many people using this medication do not||
0370|089|S|have serious side effects.||
0370|090|S|   Tell your doctor right away if you have any serious side||
0370|091|S|effects, including: unusual lumps/moles/skin changes,||
0370|092|S|numbness/tingling of arms/legs, worsening shortness of breath,||
0370|093|S|coughing up blood, muscle/joint pain, signs of infection (such as||
0370|094|S|sore throat that doesn't go away, fever, chills).||
0370|095|S|   Get medical help right away if you have any very serious side||
0370|096|S|effects, including: chest/jaw/left arm pain, unusual sweating,||
0370|097|S|weakness on one side of the body, sudden vision changes,||
0370|098|S|confusion, trouble speaking, pain/redness/swelling of the legs.||
0370|099|S|   This is not a complete list of possible side effects. If you||
0370|100|S|notice other effects not listed above, contact your doctor or||
0370|101|S|pharmacist.||
0370|102|S|   In the US -||
0370|103|S|   Call your doctor for medical advice about side effects. You||
0370|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0370|105|S|www.fda.gov/medwatch.||
0370|106|S|   In Canada - Call your doctor for medical advice about side||
0370|107|S|effects. You may report side effects to Health Canada at||
0370|108|S|1-866-234-2345.||
0370|109|B|||
0370|110|P|PRECAUTIONS:  See also Warning section.||
0370|111|P|   Before using omalizumab, tell your doctor or pharmacist if you||
0370|112|P|are allergic to it; or if you have any other allergies. This||
0370|113|P|product may contain inactive ingredients (such as latex found in||
0370|114|P|some brands), which can cause allergic reactions or other||
0370|115|P|problems. Talk to your pharmacist for more details.||
0370|116|P|   Before using this medication, tell your doctor or pharmacist||
0370|117|P|your medical history.||
0370|118|P|   Before having surgery, tell your doctor or dentist about all||
0370|119|P|the products you use (including prescription drugs,||
0370|120|P|nonprescription drugs, and herbal products).||
0370|121|P|   During pregnancy, this medication should be used only when||
0370|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
0370|123|P|   It is unknown if this drug passes into breast milk. Consult||
0370|124|P|your doctor before breastfeeding.||
0370|125|B|||
0370|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0370|127|I|medications work or increase your risk for serious side effects.||
0370|128|I|This document does not contain all possible drug interactions.||
0370|129|I|Keep a list of all the products you use (including||
0370|130|I|prescription/nonprescription drugs and herbal products) and share||
0370|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
0370|132|I|the dosage of any medicines without your doctor's approval.||
0370|133|B|||
0370|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0370|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0370|136|O|poison control center right away. US residents can call||
0370|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0370|138|B|||
0370|139|N|NOTES:  Lab and/or medical tests (such as lung function, antibody||
0370|140|N|levels) should be done before you start using this medication and||
0370|141|N|while you are using it. Keep all medical and lab appointments.||
0370|142|N|Consult your doctor for more details.||
0370|143|N|   Avoid substances that can worsen breathing problems by causing||
0370|144|N|irritation or allergic reaction, such as smoke, pollen, pet||
0370|145|N|dander, dust, and mold.||
0370|146|B|||
0370|147|D|MISSED DOSE:  It is important to get each dose of this medication||
0370|148|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0370|149|D|right away for a new dosing schedule.||
0370|150|B|||
0370|151|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
0370|152|R|medication in the original carton to protect from light. This||
0370|153|R|medication may be taken out of the refrigerator and put back in||
0370|154|R|the refrigerator if needed. The total time out of the||
0370|155|R|refrigerator should not be more than 2 days. Keep all medications||
0370|156|R|away from children and pets.||
0370|157|R|   Do not flush medications down the toilet or pour them into a||
0370|158|R|drain unless instructed to do so. Properly discard this product||
0370|159|R|when it is expired or no longer needed. Consult your pharmacist||
0370|160|R|or local waste disposal company.||
0370|161|B|||
0370|162|A|Information last revised April 2025.||
0370|163|A|Copyright(c) 2025 First Databank, Inc.||
0370|164|B|||
0371|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0371|002|Z|does NOT have all possible information about this product. This||
0371|003|Z|information does not assure that this product is safe, effective,||
0371|004|Z|or appropriate for you. This information is not individual||
0371|005|Z|medical advice and does not substitute for the advice of your||
0371|006|Z|health care professional. Always ask your health care||
0371|007|Z|professional for complete information about this product and your||
0371|008|Z|specific health needs.||
0371|009|B|||
0371|010|T|LISINOPRIL/HYDROCHLOROTHIAZIDE - ORAL||
0371|011|F|(lye-SIN-oh-pril/HYE-droe-KLOR-oh-THYE-a-zide)||
0371|012|B|||
0371|013|C|COMMON BRAND NAME(S): Prinzide, Zestoretic||
0371|014|B|||
0371|015|W|WARNING:  Lisinopril can cause serious (possibly fatal) harm to||
0371|016|W|an unborn baby if used during pregnancy. It is important to||
0371|017|W|prevent pregnancy while taking this medication. Consult your||
0371|018|W|doctor for more details and to discuss the use of reliable forms||
0371|019|W|of birth control while taking this medication. If you are||
0371|020|W|planning pregnancy, become pregnant, or think you may be||
0371|021|W|pregnant, tell your doctor right away.||
0371|022|B|||
0371|023|U|USES:  This medication is used to treat high blood pressure.||
0371|024|U|Lowering high blood pressure helps prevent strokes, heart||
0371|025|U|attacks, and kidney problems. This product contains two||
0371|026|U|medications: lisinopril and hydrochlorothiazide. Lisinopril is an||
0371|027|U|ACE inhibitor and works by relaxing blood vessels so that blood||
0371|028|U|can flow more easily. Hydrochlorothiazide is a "water pill"||
0371|029|U|(diuretic) that causes you to make more urine, which helps your||
0371|030|U|body get rid of extra salt and water.||
0371|031|U|   This product is used when one drug is not controlling your||
0371|032|U|blood pressure. Your doctor may direct you to take the individual||
0371|033|U|medications first, and then switch you to this combination||
0371|034|U|product. Do not keep taking the individual medications||
0371|035|U|(lisinopril and/or hydrochlorothiazide) after you start this||
0371|036|U|medication.||
0371|037|B|||
0371|038|V|OTHER USES:  This section contains uses of this drug that are not||
0371|039|V|listed in the approved professional labeling for the drug but||
0371|040|V|that may be prescribed by your health care professional. Use this||
0371|041|V|drug for a condition that is listed in this section only if it||
0371|042|V|has been so prescribed by your health care professional.||
0371|043|V|   This drug may also be used for heart failure.||
0371|044|B|||
0371|045|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0371|046|H|from your pharmacist before you start taking this medication and||
0371|047|H|each time you get a refill. If you have any questions, ask your||
0371|048|H|doctor or pharmacist.||
0371|049|H|   Take this medication by mouth with or without food as directed||
0371|050|H|by your doctor, usually once daily in the morning. If this||
0371|051|H|medication causes you to urinate more often, it is best to take||
0371|052|H|it at least 4 hours before your bedtime to prevent having to get||
0371|053|H|up to urinate.||
0371|054|H|   If you also take certain drugs to lower your cholesterol (bile||
0371|055|H|acid-binding resins such as cholestyramine or colestipol), take||
0371|056|H|lisinopril/hydrochlorothiazide at least 4 hours before or at||
0371|057|H|least 4 to 6 hours after these medications.||
0371|058|H|   The dosage is based on your medical condition and response to||
0371|059|H|treatment.||
0371|060|H|   Use this medication regularly to get the most benefit from it.||
0371|061|H|To help you remember, take it at the same time each day. Keep||
0371|062|H|taking this medication even if you feel well. Most people with||
0371|063|H|high blood pressure do not feel sick.||
0371|064|H|   Tell your doctor if your condition does not get better or if||
0371|065|H|it gets worse (your blood pressure readings remain high or||
0371|066|H|increase).||
0371|067|B|||
0371|068|S|SIDE EFFECTS:  Dizziness, lightheadedness, tiredness, or headache||
0371|069|S|may occur as your body adjusts to the medication. Dry cough may||
0371|070|S|also occur. If any of these effects last or get worse, tell your||
0371|071|S|doctor or pharmacist promptly.||
0371|072|S|   To reduce the risk of dizziness and lightheadedness, get up||
0371|073|S|slowly when rising from a sitting or lying position.||
0371|074|S|   Remember that this medication has been prescribed because your||
0371|075|S|doctor has judged that the benefit to you is greater than the||
0371|076|S|risk of side effects. Many people using this medication do not||
0371|077|S|have serious side effects.||
0371|078|S|   This product may cause dehydration and electrolyte imbalance.||
0371|079|S|Tell your doctor right away if you have any symptoms of||
0371|080|S|dehydration or electrolyte imbalance, including unusual dry||
0371|081|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0371|082|S|heartbeat, or confusion.||
0371|083|S|   Tell your doctor right away if you have any serious side||
0371|084|S|effects, including: fainting, signs of kidney problems (such as||
0371|085|S|change in the amount of urine), decrease in vision, eye pain.||
0371|086|S|   This product may rarely cause serious (possibly fatal) liver||
0371|087|S|problems. Get medical help right away if you have any symptoms of||
0371|088|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0371|089|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0371|090|S|urine.||
0371|091|S|   A very serious allergic reaction to this drug is rare.||
0371|092|S|However, get medical help right away if you notice any symptoms||
0371|093|S|of a serious allergic reaction, including: rash, itching/swelling||
0371|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0371|095|S|breathing.||
0371|096|S|   This is not a complete list of possible side effects. If you||
0371|097|S|notice other effects not listed above, contact your doctor or||
0371|098|S|pharmacist.||
0371|099|S|   In the US -||
0371|100|S|   Call your doctor for medical advice about side effects. You||
0371|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0371|102|S|www.fda.gov/medwatch.||
0371|103|S|   In Canada - Call your doctor for medical advice about side||
0371|104|S|effects. You may report side effects to Health Canada at||
0371|105|S|1-866-234-2345.||
0371|106|B|||
0371|107|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0371|108|P|pharmacist if you are allergic to lisinopril or||
0371|109|P|hydrochlorothiazide; or to other ACE inhibitors (such as||
0371|110|P|captopril, benazepril); or if you have any other allergies. This||
0371|111|P|product may contain inactive ingredients, which can cause||
0371|112|P|allergic reactions or other problems. Talk to your pharmacist for||
0371|113|P|more details.||
0371|114|P|   Before using this medication, tell your doctor or pharmacist||
0371|115|P|your medical history, especially of: history of an allergic||
0371|116|P|reaction that included swelling of the face/lips/tongue/throat||
0371|117|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
0371|118|P|dialysis), desensitizing treatment for bee/wasp sting allergy,||
0371|119|P|gout, lupus, kidney disease, liver disease, skin cancer.||
0371|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0371|121|P|can make you more dizzy. Do not drive, use machinery, or do||
0371|122|P|anything that needs alertness until you can do it safely. Limit||
0371|123|P|alcoholic beverages. Talk to your doctor if you are using||
0371|124|P|marijuana (cannabis).||
0371|125|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0371|126|P|and cause you to feel lightheaded. Tell your doctor if you have||
0371|127|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0371|128|P|of fluids unless your doctor tells you not to.||
0371|129|P|   If you have diabetes, this product may affect your blood||
0371|130|P|sugar. Check your blood sugar regularly as directed and share the||
0371|131|P|results with your doctor. Your doctor may need to adjust your||
0371|132|P|diabetes medication, exercise program, or diet.||
0371|133|P|   This medication may make you more sensitive to the sun. It may||
0371|134|P|also increase your risk for skin cancer, especially if you take||
0371|135|P|it for a long time. Limit your time in the sun. Avoid tanning||
0371|136|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0371|137|P|when outdoors. Tell your doctor right away if you get sunburned,||
0371|138|P|have skin blisters/redness, or notice new or changed moles/skin||
0371|139|P|lesions.||
0371|140|P|   This product may affect your potassium levels. Before using||
0371|141|P|potassium supplements or salt substitutes that contain potassium,||
0371|142|P|consult your doctor or pharmacist.||
0371|143|P|   Before having surgery, tell your doctor or dentist about all||
0371|144|P|the products you use (including prescription drugs,||
0371|145|P|nonprescription drugs, and herbal products).||
0371|146|P|   Older adults may be more sensitive to the side effects of this||
0371|147|P|drug, especially dizziness and change in the amount of urine||
0371|148|P|(kidney problems).||
0371|149|P|   Tell your doctor if you are pregnant or plan to become||
0371|150|P|pregnant. You should not become pregnant while using this||
0371|151|P|product. Lisinopril may harm an unborn baby. If you become||
0371|152|P|pregnant, talk to your doctor right away about the risks and||
0371|153|P|benefits of this medication. (See also Warning section.)||
0371|154|P|   It is unknown if lisinopril passes into breast milk.||
0371|155|P|Hydrochlorothiazide passes into breast milk, but is unlikely to||
0371|156|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0371|157|B|||
0371|158|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
0371|159|I|   Drug interactions may change how your medications work or||
0371|160|I|increase your risk for serious side effects. This document does||
0371|161|I|not contain all possible drug interactions. Keep a list of all||
0371|162|I|the products you use (including prescription/nonprescription||
0371|163|I|drugs and herbal products) and share it with your doctor and||
0371|164|I|pharmacist. Do not start, stop, or change the dosage of any||
0371|165|I|medicines without your doctor's approval.||
0371|166|I|   Some products that may interact with this drug include:||
0371|167|I|aliskiren, dofetilide, certain drugs that weaken the immune||
0371|168|I|system/increase the risk of infection (such as everolimus,||
0371|169|I|sirolimus), lithium, drugs that may increase the level of||
0371|170|I|potassium in the blood (such as ARBs including||
0371|171|I|losartan/valsartan, birth control pills containing drospirenone),||
0371|172|I|sacubitril.||
0371|173|I|   Some products have ingredients that could raise your blood||
0371|174|I|pressure or worsen your heart failure. Tell your pharmacist what||
0371|175|I|products you are using, and ask how to use them safely||
0371|176|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0371|177|I|ibuprofen/naproxen).||
0371|178|I|   This medication may interfere with certain lab tests (such as||
0371|179|I|parathyroid function), possibly causing false test results. Make||
0371|180|I|sure lab personnel and all your doctors know you use this drug.||
0371|181|B|||
0371|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0371|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0371|184|O|poison control center right away. US residents can call||
0371|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0371|186|O|Symptoms of overdose may include: severe dizziness, fainting.||
0371|187|B|||
0371|188|N|NOTES:  Do not share this medication with others.||
0371|189|N|   Lifestyle changes that may help this medication work better||
0371|190|N|include exercising, stopping smoking, and eating a||
0371|191|N|low-cholesterol/low-fat diet. Consult your doctor for more||
0371|192|N|details.||
0371|193|N|   Lab and/or medical tests (such as kidney function, potassium||
0371|194|N|levels, skin exams, cholesterol levels) should be done while you||
0371|195|N|are taking this medication. Keep all medical and lab||
0371|196|N|appointments. Consult your doctor for more details.||
0371|197|N|   Check your blood pressure and pulse (heart rate) regularly||
0371|198|N|while taking this medication. Learn how to check your own blood||
0371|199|N|pressure and pulse at home, and share the results with your||
0371|200|N|doctor.||
0371|201|B|||
0371|202|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0371|203|D|remember. If it is near the time of the next dose, skip the||
0371|204|D|missed dose. Take your next dose at the regular time. Do not||
0371|205|D|double the dose to catch up.||
0371|206|B|||
0371|207|R|STORAGE:  Store at room temperature away from light and moisture.||
0371|208|R|Do not store in the bathroom. Keep all medications away from||
0371|209|R|children and pets.||
0371|210|R|   Do not flush medications down the toilet or pour them into a||
0371|211|R|drain unless instructed to do so. Properly discard this product||
0371|212|R|when it is expired or no longer needed. Consult your pharmacist||
0371|213|R|or local waste disposal company.||
0371|214|B|||
0371|215|A|Information last revised March 2025.||
0371|216|A|Copyright(c) 2025 First Databank, Inc.||
0371|217|B|||
0372|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0372|002|Z|does NOT have all possible information about this product. This||
0372|003|Z|information does not assure that this product is safe, effective,||
0372|004|Z|or appropriate for you. This information is not individual||
0372|005|Z|medical advice and does not substitute for the advice of your||
0372|006|Z|health care professional. Always ask your health care||
0372|007|Z|professional for complete information about this product and your||
0372|008|Z|specific health needs.||
0372|009|B|||
0372|010|T|CANDESARTAN - ORAL||
0372|011|F|(KAN-de-SAR-tan)||
0372|012|B|||
0372|013|C|COMMON BRAND NAME(S): Atacand||
0372|014|B|||
0372|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
0372|016|W|unborn baby if used during pregnancy. It is important to prevent||
0372|017|W|pregnancy while taking this medication. Consult your doctor for||
0372|018|W|more details and to discuss the use of reliable forms of birth||
0372|019|W|control while taking this medication. If you are planning||
0372|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
0372|021|W|your doctor right away.||
0372|022|B|||
0372|023|U|USES:  Candesartan is used to treat high blood pressure||
0372|024|U|(hypertension). Lowering high blood pressure helps prevent||
0372|025|U|strokes, heart attacks, and kidney problems. Candesartan belongs||
0372|026|U|to a class of drugs called angiotensin receptor blockers (ARBs).||
0372|027|U|It works by relaxing blood vessels so blood can flow more easily.||
0372|028|U|   This medication is also used to treat heart failure.||
0372|029|U|   This medication is not recommended for use in children younger||
0372|030|U|than 1 year due to increased risk of side effects.||
0372|031|B|||
0372|032|V|OTHER USES:  This section contains uses of this drug that are not||
0372|033|V|listed in the approved professional labeling for the drug but||
0372|034|V|that may be prescribed by your health care professional. Use this||
0372|035|V|drug for a condition that is listed in this section only if it||
0372|036|V|has been so prescribed by your health care professional.||
0372|037|V|   This medication may also be used for kidney disease and to||
0372|038|V|help protect the kidneys from harm due to diabetes.||
0372|039|B|||
0372|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0372|041|H|from your pharmacist before you start taking candesartan and each||
0372|042|H|time you get a refill. If you have any questions, ask your doctor||
0372|043|H|or pharmacist.||
0372|044|H|   Take this medication by mouth with or without food as directed||
0372|045|H|by your doctor, usually once or twice daily.||
0372|046|H|   The dosage is based on your medical condition and response to||
0372|047|H|treatment. Children's dosage is also based on weight.||
0372|048|H|   Use this medication regularly to get the most benefit from it.||
0372|049|H|To help you remember, take it at the same time(s) each day. Keep||
0372|050|H|taking this medication even if you feel well. Most people with||
0372|051|H|high blood pressure do not feel sick. For the treatment of high||
0372|052|H|blood pressure, it may take up to 6 weeks before you get the full||
0372|053|H|benefit of this drug.||
0372|054|H|   Tell your doctor if your condition does not get better or if||
0372|055|H|it gets worse (for example, your blood pressure readings remain||
0372|056|H|high or increase).||
0372|057|B|||
0372|058|S|SIDE EFFECTS:  Dizziness, tiredness, or lightheadedness may occur||
0372|059|S|as your body adjusts to the medication. Runny nose or sore throat||
0372|060|S|may also occur. If any of these effects last or get worse, tell||
0372|061|S|your doctor or pharmacist promptly.||
0372|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
0372|063|S|slowly when rising from a sitting or lying position.||
0372|064|S|   Remember that this medication has been prescribed because your||
0372|065|S|doctor has judged that the benefit to you is greater than the||
0372|066|S|risk of side effects. Many people using this medication do not||
0372|067|S|have serious side effects.||
0372|068|S|   Tell your doctor right away if you have any serious side||
0372|069|S|effects, including: fainting, symptoms of a high potassium blood||
0372|070|S|level (such as muscle weakness, slow/irregular heartbeat).||
0372|071|S|   Although candesartan may be used to prevent kidney problems or||
0372|072|S|treat people who have kidney problems, it may also rarely cause||
0372|073|S|serious kidney problems or make them worse. Your doctor will||
0372|074|S|check your kidney function while you are taking candesartan. Tell||
0372|075|S|your doctor right away if you have any signs of kidney problems||
0372|076|S|such as a change in the amount of urine.||
0372|077|S|   A very serious allergic reaction to this drug is rare.||
0372|078|S|However, get medical help right away if you notice any symptoms||
0372|079|S|of a serious allergic reaction, including: rash, itching/swelling||
0372|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0372|081|S|breathing.||
0372|082|S|   This is not a complete list of possible side effects. If you||
0372|083|S|notice other effects not listed above, contact your doctor or||
0372|084|S|pharmacist.||
0372|085|S|   In the US -||
0372|086|S|   Call your doctor for medical advice about side effects. You||
0372|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0372|088|S|www.fda.gov/medwatch.||
0372|089|S|   In Canada - Call your doctor for medical advice about side||
0372|090|S|effects. You may report side effects to Health Canada at||
0372|091|S|1-866-234-2345.||
0372|092|B|||
0372|093|P|PRECAUTIONS:  Before taking candesartan, tell your doctor or||
0372|094|P|pharmacist if you are allergic to it; or if you have any other||
0372|095|P|allergies. This product may contain inactive ingredients, which||
0372|096|P|can cause allergic reactions or other problems. Talk to your||
0372|097|P|pharmacist for more details.||
0372|098|P|   Before using this medication, tell your doctor or pharmacist||
0372|099|P|your medical history, especially of: liver disease, high level of||
0372|100|P|potassium in the blood, dehydration.||
0372|101|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0372|102|P|can make you more dizzy. Do not drive, use machinery, or do||
0372|103|P|anything that needs alertness until you can do it safely. Limit||
0372|104|P|alcoholic beverages. Talk to your doctor if you are using||
0372|105|P|marijuana (cannabis).||
0372|106|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0372|107|P|and cause you to feel lightheaded. Tell your doctor if you have||
0372|108|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0372|109|P|of fluids unless your doctor tells you not to.||
0372|110|P|   This product may increase your potassium levels. Before using||
0372|111|P|potassium supplements or salt substitutes that contain potassium,||
0372|112|P|consult your doctor or pharmacist.||
0372|113|P|   Before having surgery, tell your doctor or dentist about all||
0372|114|P|the products you use (including prescription drugs,||
0372|115|P|nonprescription drugs, and herbal products).||
0372|116|P|   Older adults may be more sensitive to the side effects of this||
0372|117|P|drug, especially dizziness, increases in potassium level, and||
0372|118|P|change in the amount of urine (kidney problems).||
0372|119|P|   Tell your doctor if you are pregnant or plan to become||
0372|120|P|pregnant. You should not become pregnant while using candesartan.||
0372|121|P|Candesartan may harm an unborn baby. If you become pregnant, talk||
0372|122|P|to your doctor right away about the risks and benefits of this||
0372|123|P|medication. (See also Warning section.)||
0372|124|P|   It is unknown if this drug passes into breast milk. Consult||
0372|125|P|your doctor before breastfeeding.||
0372|126|B|||
0372|127|I|DRUG INTERACTIONS:  See also Precautions section.||
0372|128|I|   Drug interactions may change how your medications work or||
0372|129|I|increase your risk for serious side effects. This document does||
0372|130|I|not contain all possible drug interactions. Keep a list of all||
0372|131|I|the products you use (including prescription/nonprescription||
0372|132|I|drugs and herbal products) and share it with your doctor and||
0372|133|I|pharmacist. Do not start, stop, or change the dosage of any||
0372|134|I|medicines without your doctor's approval.||
0372|135|I|   Some products that may interact with this drug include:||
0372|136|I|aliskiren, lithium, drugs that may increase the level of||
0372|137|I|potassium in the blood (such as sparsentan, ACE inhibitors||
0372|138|I|including benazepril/lisinopril, birth control pills containing||
0372|139|I|drospirenone).||
0372|140|I|   Some products have ingredients that could raise your blood||
0372|141|I|pressure or worsen your heart failure. Tell your pharmacist what||
0372|142|I|products you are using, and ask how to use them safely||
0372|143|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0372|144|I|ibuprofen/naproxen).||
0372|145|B|||
0372|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0372|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0372|148|O|poison control center right away. US residents can call||
0372|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0372|150|O|Symptoms of overdose may include: fast heartbeat, severe||
0372|151|O|dizziness, fainting.||
0372|152|B|||
0372|153|N|NOTES:  Do not share this medication with others.||
0372|154|N|   Lab and/or medical tests (such as kidney function, potassium||
0372|155|N|levels) should be done while you are taking this medication. Keep||
0372|156|N|all medical and lab appointments. Consult your doctor for more||
0372|157|N|details.||
0372|158|N|   Lifestyle changes that may help this medication work better||
0372|159|N|include stress reduction programs, exercise, and dietary changes.||
0372|160|N|Talk to your doctor or pharmacist about lifestyle changes that||
0372|161|N|might benefit you.||
0372|162|N|   Have your blood pressure checked regularly while taking this||
0372|163|N|medication. Learn how to monitor your own blood pressure at home,||
0372|164|N|and share the results with your doctor.||
0372|165|B|||
0372|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0372|167|D|remember. If it is near the time of the next dose, skip the||
0372|168|D|missed dose. Take your next dose at the regular time. Do not||
0372|169|D|double the dose to catch up.||
0372|170|B|||
0372|171|R|STORAGE:  Store at room temperature away from light and moisture.||
0372|172|R|Do not store in the bathroom. Keep all medications away from||
0372|173|R|children and pets.||
0372|174|R|   Do not flush medications down the toilet or pour them into a||
0372|175|R|drain unless instructed to do so. Properly discard this product||
0372|176|R|when it is expired or no longer needed. Consult your pharmacist||
0372|177|R|or local waste disposal company.||
0372|178|B|||
0372|179|A|Information last revised August 2024.||
0372|180|A|Copyright(c) 2025 First Databank, Inc.||
0372|181|B|||
0373|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0373|002|Z|does NOT have all possible information about this product. This||
0373|003|Z|information does not assure that this product is safe, effective,||
0373|004|Z|or appropriate for you. This information is not individual||
0373|005|Z|medical advice and does not substitute for the advice of your||
0373|006|Z|health care professional. Always ask your health care||
0373|007|Z|professional for complete information about this product and your||
0373|008|Z|specific health needs.||
0373|009|B|||
0373|010|T|INFLUENZA VIRUS VACCINE LIVE - NASAL||
0373|011|F|(IN-floo-EN-za VYE-rus vak-SEEN)||
0373|012|B|||
0373|013|C|COMMON BRAND NAME(S): FluMist||
0373|014|B|||
0373|015|U|USES:  This vaccine is used to help prevent influenza ("flu") in||
0373|016|U|children and adults. Influenza can cause serious (rarely fatal)||
0373|017|U|illness, especially in people at high risk from the infection||
0373|018|U|(such as young children, older adults, people with chronic health||
0373|019|U|problems). This vaccine is also called the seasonal flu vaccine.||
0373|020|U|It contains live viruses that have been weakened. It works by||
0373|021|U|increasing the body's natural defense (immunity) against the||
0373|022|U|virus.||
0373|023|U|   Vaccination is the best way to protect against this infection.||
0373|024|U|It can help prevent the infection or decrease the seriousness of||
0373|025|U|the illness if you become infected. Since different types of flu||
0373|026|U|viruses cause infection every flu season, a new vaccine is made||
0373|027|U|and given every year.||
0373|028|U|   Vaccines may not fully protect everyone who receives them.||
0373|029|B|||
0373|030|H|HOW TO USE:  Read all vaccine information available from your||
0373|031|H|health care professional before receiving the vaccine. If you are||
0373|032|H|using this vaccine at home, read the Instructions for Use before||
0373|033|H|you start using this vaccine. Learn all preparation and usage||
0373|034|H|instructions from your health care professional.||
0373|035|H|   This vaccine is usually given by a health care professional or||
0373|036|H|may also be used at home. It is sprayed into each nostril, one at||
0373|037|H|a time. Sit or stand upright with your head tilted back when you||
0373|038|H|receive the vaccine.||
0373|039|H|   The vaccination is usually given once a year during September||
0373|040|H|to November, the time when the number of flu cases begin to||
0373|041|H|increase (the start of "flu season"). Children younger than 9||
0373|042|H|years may receive a second dose depending on when the first dose||
0373|043|H|was given. Discuss the dose schedule with your health care||
0373|044|H|professional.||
0373|045|B|||
0373|046|S|SIDE EFFECTS:  Cough, runny nose, sneezing, sore throat, fever,||
0373|047|S|headache, chills, or tiredness may occur. If any of these effects||
0373|048|S|last or get worse, tell your health care professional promptly.||
0373|049|S|   Remember that this vaccine has been prescribed because your||
0373|050|S|health care professional has judged that the benefit to you is||
0373|051|S|greater than the risk of side effects. Many people using this||
0373|052|S|vaccine do not have serious side effects.||
0373|053|S|   A very serious allergic reaction to this vaccine is rare.||
0373|054|S|However, get medical help right away if you notice any symptoms||
0373|055|S|of a serious allergic reaction, including: rash, itching/swelling||
0373|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0373|057|S|breathing.||
0373|058|S|   This is not a complete list of possible side effects. If you||
0373|059|S|notice other effects not listed above, contact your health care||
0373|060|S|professional.||
0373|061|S|   Contact the health care professional for medical advice about||
0373|062|S|side effects. The following numbers do not provide medical||
0373|063|S|advice, but in the US you may report side effects to the Vaccine||
0373|064|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
0373|065|S|Canada, you may call the Vaccine Safety Section at Public Health||
0373|066|S|Agency of Canada at 1-866-844-0018.||
0373|067|B|||
0373|068|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
0373|069|P|care professional if you are allergic to it; or if you have any||
0373|070|P|other allergies. This product may contain inactive ingredients||
0373|071|P|(such as gentamicin, gelatin, arginine), which can cause allergic||
0373|072|P|reactions or other problems. Talk to your health care||
0373|073|P|professional for more details.||
0373|074|P|   Before receiving this vaccine, tell your health care||
0373|075|P|professional your medical history, especially of: breathing||
0373|076|P|problems (such as asthma, wheezing, lung disease), current||
0373|077|P|fever/illness, diabetes, a certain nerve disorder (Guillain-Barre||
0373|078|P|syndrome), immune system disorders (such as due to HIV infection,||
0373|079|P|certain cancers such as leukemia/lymphoma, cancer or radiation||
0373|080|P|treatment), kidney disease, vaccination history (including||
0373|081|P|previous reactions to any vaccines).||
0373|082|P|   This vaccine contains a weakened form of the flu virus. After||
0373|083|P|receiving the vaccine, you may be able to infect others with flu||
0373|084|P|for up to 3 weeks. Rarely, infections may occur in people in||
0373|085|P|close contact with someone who has received this vaccine. Caution||
0373|086|P|is advised if you have regular close contact with||
0373|087|P|family/household members with weakened immune systems (for||
0373|088|P|example, due to cancer).||
0373|089|P|   Children aged 2 to 17 years who are taking aspirin should not||
0373|090|P|receive this vaccine due to the risk for developing Reye's||
0373|091|P|syndrome, a rare but serious condition. Also, children in this||
0373|092|P|age group should not use products containing aspirin for 4 weeks||
0373|093|P|after receiving this vaccine unless directed by the doctor.||
0373|094|P|Consult the doctor for details.||
0373|095|P|   This form of the vaccine is not recommended for use during||
0373|096|P|pregnancy. Instead, a flu vaccine that is given by injection is||
0373|097|P|recommended. Consult your health care professional for more||
0373|098|P|details.||
0373|099|P|   It is unknown if this vaccine passes into breast milk. Consult||
0373|100|P|your health care professional before breastfeeding.||
0373|101|B|||
0373|102|I|DRUG INTERACTIONS:  See also Precautions section.||
0373|103|I|   Drug interactions may change how your medications work or||
0373|104|I|increase your risk for serious side effects. This document does||
0373|105|I|not contain all possible drug interactions. Keep a list of all||
0373|106|I|the products you use (including prescription/nonprescription||
0373|107|I|drugs and herbal products) and share it with your health care||
0373|108|I|professional. Do not start, stop, or change the dosage of any||
0373|109|I|medicines without your doctor's approval.||
0373|110|I|   Some products that may interact with this vaccine are: drugs||
0373|111|I|that weaken the immune system (including cyclosporine,||
0373|112|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
0373|113|I|prednisone).||
0373|114|I|   Avoid taking certain drugs that fight flu virus (such as||
0373|115|I|amantadine, oseltamivir, rimantadine) when receiving this||
0373|116|I|vaccine. If you are currently taking any of these drugs, you||
0373|117|I|should not receive this vaccine until at least 48 hours after||
0373|118|I|stopping treatment. Do not take any of these drugs until at least||
0373|119|I|2 weeks after receiving this vaccine.||
0373|120|B|||
0373|121|O|OVERDOSE:  Not applicable.||
0373|122|B|||
0373|123|N|NOTES:  Keep all medical and lab appointments.||
0373|124|N|   Keep vaccine records for yourself and your children and||
0373|125|N|provide them to the health care professionals to prevent||
0373|126|N|unnecessary re-vaccinations.||
0373|127|B|||
0373|128|D|MISSED DOSE:  This vaccine is usually given once every flu||
0373|129|D|season. If your child is prescribed a second dose, mark your||
0373|130|D|calendar with a reminder. If your child misses the dose, call the||
0373|131|D|health care professional to reschedule.||
0373|132|B|||
0373|133|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
0373|134|R|product in the original carton to protect from light. This||
0373|135|R|product may be taken out of the refrigerator and put back in the||
0373|136|R|refrigerator only once, if needed. The total time out of the||
0373|137|R|refrigerator should not be more than 12 hours. Keep all||
0373|138|R|medications away from children and pets.||
0373|139|R|   Do not flush medications down the toilet or pour them into a||
0373|140|R|drain unless instructed to do so. Properly discard this product||
0373|141|R|when it is expired or no longer needed. Consult your pharmacist||
0373|142|R|or local waste disposal company.||
0373|143|B|||
0373|144|A|Information last revised July 2025.||
0373|145|A|Copyright(c) 2025 First Databank, Inc.||
0373|146|B|||
0374|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0374|002|Z|does NOT have all possible information about this product. This||
0374|003|Z|information does not assure that this product is safe, effective,||
0374|004|Z|or appropriate for you. This information is not individual||
0374|005|Z|medical advice and does not substitute for the advice of your||
0374|006|Z|health care professional. Always ask your health care||
0374|007|Z|professional for complete information about this product and your||
0374|008|Z|specific health needs.||
0374|009|B|||
0374|010|T|LEVONORGESTREL/ETHINYL ESTRADIOL 13 WEEK CONTRACEPTIVE - ORAL||
0374|011|F|(LEE-voe-nor-JES-trel/ETH-i-nil ES-tra-DYE-ol)||
0374|012|B|||
0374|013|C|COMMON BRAND NAME(S): Seasonale||
0374|014|B|||
0374|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
0374|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
0374|017|W|stroke, heart attack, blood clots, and high blood pressure from||
0374|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
0374|019|W|of these serious problems increases with age and with the number||
0374|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
0374|021|B|||
0374|022|U|USES:  This combination hormone medication is used to prevent||
0374|023|U|pregnancy. It contains 2 hormones: a progestin (levonorgestrel)||
0374|024|U|and an estrogen (ethinyl estradiol).||
0374|025|U|   Besides preventing pregnancy, birth control pills may make||
0374|026|U|your periods more regular, decrease blood loss and painful||
0374|027|U|periods, decrease your risk of ovarian cysts, and also treat||
0374|028|U|acne.||
0374|029|U|   This medication does not protect against sexually transmitted||
0374|030|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
0374|031|U|an effective barrier method (latex or polyurethane condom/dental||
0374|032|U|dams) during sexual activity will help to decrease your risk of||
0374|033|U|infection.||
0374|034|B|||
0374|035|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0374|036|H|your pharmacist before you start using this product and each time||
0374|037|H|you get a refill. The leaflet contains very important information||
0374|038|H|on when to take your pills and what to do if you miss a dose. If||
0374|039|H|you have any questions, ask your doctor or pharmacist.||
0374|040|H|   Take this medication by mouth as directed by your doctor,||
0374|041|H|usually once daily. Pick a time of day that is easy for you to||
0374|042|H|remember, and take your pill at the same time each day.||
0374|043|H|   It is very important to keep taking this medication exactly as||
0374|044|H|prescribed by your doctor. Follow the package instructions to||
0374|045|H|find the first tablet, start with the first tablet in the pack,||
0374|046|H|and take them in the correct order. Do not skip any doses.||
0374|047|H|Pregnancy is more likely if you miss pills, start a new pack||
0374|048|H|late, or take your pill at a different time of the day than||
0374|049|H|usual.||
0374|050|H|   Vomiting or diarrhea can prevent your birth control pills from||
0374|051|H|working well. If you have vomiting or diarrhea, you may need to||
0374|052|H|use a backup birth control method (such as condoms, spermicide).||
0374|053|H|Follow the directions in the Patient Information Leaflet and||
0374|054|H|check with your doctor or pharmacist for more details.||
0374|055|H|   Taking this medication after your evening meal or at bedtime||
0374|056|H|may help if you have stomach upset or nausea with the medication.||
0374|057|H|You may choose to take this medication at another time of day||
0374|058|H|that is easier for you to remember. No matter what dosing||
0374|059|H|schedule you use, it is very important that you take this||
0374|060|H|medication at the same time each day, 24 hours apart. Ask your||
0374|061|H|doctor or pharmacist if you have any questions.||
0374|062|H|   Begin taking this medication on the first Sunday following the||
0374|063|H|beginning of your menstrual period. If your period begins on a||
0374|064|H|Sunday, begin taking this medication on that day. Your pill pack||
0374|065|H|contains 84 active pills (with hormones) and 7 inactive pills||
0374|066|H|(without hormones). Take one active pill daily for 84 days in a||
0374|067|H|row. The day after you finish all the active pills, start taking||
0374|068|H|one inactive pill daily for 7 days in a row. You should have your||
0374|069|H|period during the week you are taking the inactive pills. The day||
0374|070|H|after you take the last inactive tablet in the pack, start a new||
0374|071|H|pack whether or not you have your period. If you do not get your||
0374|072|H|period, consult your doctor.||
0374|073|H|   If this is the first time you are using this medication, use a||
0374|074|H|backup form of non-hormonal birth control (such as condoms,||
0374|075|H|spermicide) for the first 7 days to prevent pregnancy until the||
0374|076|H|medication has enough time to work. If you start on the first day||
0374|077|H|of your period, you do not need to use backup birth control the||
0374|078|H|first week.||
0374|079|H|   Ask your doctor or pharmacist about how to switch from other||
0374|080|H|forms of hormonal birth control (such as patch, other birth||
0374|081|H|control pills) to this product. If any information is unclear,||
0374|082|H|consult the Patient Information Leaflet or your doctor or||
0374|083|H|pharmacist.||
0374|084|B|||
0374|085|S|SIDE EFFECTS:  Nausea, vomiting, headache, bloating, breast||
0374|086|S|tenderness, swelling of the ankles/feet (fluid retention), or||
0374|087|S|weight change may occur. Vaginal bleeding between periods||
0374|088|S|(spotting) may occur, especially during the first few months of||
0374|089|S|use. If any of these effects last or get worse, tell your doctor||
0374|090|S|or pharmacist promptly.||
0374|091|S|   You should not have your period during the 3 months that you||
0374|092|S|are taking the active pills. Instead, you will have your period||
0374|093|S|once every 3 months, during the week that you are taking the||
0374|094|S|inactive pills. This effect is normal with this product. However,||
0374|095|S|if you do not have your period while taking the inactive pills,||
0374|096|S|contact your doctor for a pregnancy test.||
0374|097|S|   Remember that this medication has been prescribed because your||
0374|098|S|doctor has judged that the benefit to you is greater than the||
0374|099|S|risk of side effects. Many people using this medication do not||
0374|100|S|have serious side effects.||
0374|101|S|   This medication may raise your blood pressure. Check your||
0374|102|S|blood pressure regularly and tell your doctor if the results are||
0374|103|S|high.||
0374|104|S|   Tell your doctor right away if you have any serious side||
0374|105|S|effects, including: lumps in the breast, mental/mood changes||
0374|106|S|(such as new/worsening depression), severe stomach/abdominal||
0374|107|S|pain, unusual changes in vaginal bleeding (such as continuous||
0374|108|S|spotting, sudden heavy bleeding, missed periods), dark urine,||
0374|109|S|yellowing eyes/skin.||
0374|110|S|   This medication may rarely cause serious (sometimes fatal)||
0374|111|S|problems from blood clots (such as heart attack, stroke, blood||
0374|112|S|clots in the lungs or legs). Get medical help right away if you||
0374|113|S|have: chest/jaw/left arm pain, confusion, sudden||
0374|114|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0374|115|S|trouble speaking, shortness of breath/rapid breathing,||
0374|116|S|sudden/severe headaches, unusual sweating, weakness on one side||
0374|117|S|of the body, sudden vision changes.||
0374|118|S|   A very serious allergic reaction to this drug is rare.||
0374|119|S|However, get medical help right away if you notice any symptoms||
0374|120|S|of a serious allergic reaction, including: rash, itching/swelling||
0374|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0374|122|S|breathing.||
0374|123|S|   This is not a complete list of possible side effects. If you||
0374|124|S|notice other effects not listed above, contact your doctor or||
0374|125|S|pharmacist.||
0374|126|S|   In the US -||
0374|127|S|   Call your doctor for medical advice about side effects. You||
0374|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0374|129|S|www.fda.gov/medwatch.||
0374|130|S|   In Canada - Call your doctor for medical advice about side||
0374|131|S|effects. You may report side effects to Health Canada at||
0374|132|S|1-866-234-2345.||
0374|133|B|||
0374|134|P|PRECAUTIONS:  See also Warning section.||
0374|135|P|   Before using this medication, tell your doctor or pharmacist||
0374|136|P|if you are allergic to ethinyl estradiol or levonorgestrel; or to||
0374|137|P|other estrogens or progestins; or if you have any other||
0374|138|P|allergies. This product may contain inactive ingredients, which||
0374|139|P|can cause allergic reactions or other problems. Talk to your||
0374|140|P|pharmacist for more details.||
0374|141|P|   Before using this medication, tell your doctor or pharmacist||
0374|142|P|your medical history, especially of: blood clots (for example, in||
0374|143|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
0374|144|P|C or protein S deficiency), high blood pressure, abnormal breast||
0374|145|P|exam, cancer (especially endometrial or breast cancer), high||
0374|146|P|cholesterol or triglyceride (blood fat) levels, depression,||
0374|147|P|diabetes, family or personal history of a certain swelling||
0374|148|P|disorder (angioedema), gallbladder problems, severe||
0374|149|P|headaches/migraines, heart problems (such as heart valve disease,||
0374|150|P|irregular heartbeat, previous heart attack), history of yellowing||
0374|151|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
0374|152|P|birth control (such as pills, patch), kidney disease, liver||
0374|153|P|disease (including tumors), obesity, stroke, swelling (edema),||
0374|154|P|thyroid problems, unexplained vaginal bleeding.||
0374|155|P|   If you have diabetes, this medication may affect your blood||
0374|156|P|sugar. Check your blood sugar regularly as directed and share the||
0374|157|P|results with your doctor. Tell your doctor right away if you have||
0374|158|P|symptoms of high blood sugar such as increased thirst/urination.||
0374|159|P|Your doctor may need to adjust your diabetes medication, exercise||
0374|160|P|program, or diet.||
0374|161|P|   Tell your doctor if you just had or will be having surgery or||
0374|162|P|if you will be confined to a bed or chair for a long time (such||
0374|163|P|as a long plane flight). These conditions increase your risk of||
0374|164|P|getting blood clots, especially if you are using hormonal birth||
0374|165|P|control. You may need to stop this medication for a time or take||
0374|166|P|special precautions.||
0374|167|P|   Before having surgery, tell your doctor or dentist about all||
0374|168|P|the products you use (including prescription drugs,||
0374|169|P|nonprescription drugs, and herbal products).||
0374|170|P|   This medication may cause blotchy, dark areas on your face and||
0374|171|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0374|172|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0374|173|P|wear protective clothing when outdoors.||
0374|174|P|   If you are nearsighted or wear contact lenses, you may develop||
0374|175|P|vision problems or trouble wearing your contact lenses. Contact||
0374|176|P|your eye doctor if these problems occur.||
0374|177|P|   It may take longer for you to become pregnant after you stop||
0374|178|P|taking birth control pills. Consult your doctor.||
0374|179|P|   This medication should not be used during pregnancy. If you||
0374|180|P|become pregnant or think you may be pregnant, tell your doctor||
0374|181|P|right away. If you have just given birth or had a pregnancy||
0374|182|P|loss/abortion after the first 3 months, talk with your doctor||
0374|183|P|about reliable forms of birth control, and find out when it is||
0374|184|P|safe to start using birth control that contains a form of||
0374|185|P|estrogen, such as this medication.||
0374|186|P|   A small amount of this medication passes into breast milk and||
0374|187|P|may have undesirable effects on a nursing infant. Consult your||
0374|188|P|doctor before breastfeeding.||
0374|189|B|||
0374|190|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0374|191|I|medications work or increase your risk for serious side effects.||
0374|192|I|This document does not contain all possible drug interactions.||
0374|193|I|Keep a list of all the products you use (including||
0374|194|I|prescription/nonprescription drugs and herbal products) and share||
0374|195|I|it with your doctor and pharmacist. Do not start, stop, or change||
0374|196|I|the dosage of any medicines without your doctor's approval.||
0374|197|I|   Some products that may interact with this drug include:||
0374|198|I|aromatase inhibitors (such as anastrozole, exemestane),||
0374|199|I|fezolinetant, ospemifene, tamoxifen, tizanidine, tranexamic acid.||
0374|200|I|   Some drugs may cause hormonal birth control to work less well||
0374|201|I|by decreasing the amount of birth control hormones in your body.||
0374|202|I|This effect can result in pregnancy. Examples include||
0374|203|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
0374|204|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
0374|205|I|seizures (such as barbiturates, carbamazepine, felbamate,||
0374|206|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
0374|207|I|nevirapine), among others.||
0374|208|I|   Tell your doctor when you start any new drug, and discuss if||
0374|209|I|you should use reliable backup birth control. Also tell your||
0374|210|I|doctor if you have any new spotting or breakthrough bleeding,||
0374|211|I|because these may be signs that your birth control is not working||
0374|212|I|well.||
0374|213|I|   This medication may interfere with certain lab tests (such as||
0374|214|I|blood clotting factors, thyroid), possibly causing false test||
0374|215|I|results. Make sure lab personnel and all your doctors know you||
0374|216|I|use this drug.||
0374|217|B|||
0374|218|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0374|219|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0374|220|O|poison control center right away. US residents can call||
0374|221|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0374|222|O|Symptoms of overdose may include severe nausea and vomiting,||
0374|223|O|sudden/unusual vaginal bleeding.||
0374|224|B|||
0374|225|N|NOTES:  Do not share this medication with others.||
0374|226|N|   Regular complete physical exams which include lab and/or||
0374|227|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
0374|228|N|Pap smear) should be done while you are taking this medication.||
0374|229|N|Follow your doctor's instructions for examining your breasts, and||
0374|230|N|report any lumps right away. Keep all medical and lab||
0374|231|N|appointments. Consult your doctor for more details.||
0374|232|B|||
0374|233|D|MISSED DOSE:  Refer to the product package information for advice||
0374|234|D|on missed doses. You may need to use backup birth control (such||
0374|235|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
0374|236|D|pharmacist if you have any questions.||
0374|237|D|   If you often forget to take your pills as directed, contact||
0374|238|D|your doctor to discuss switching to another form of birth||
0374|239|D|control.||
0374|240|B|||
0374|241|R|STORAGE:  Store at room temperature away from light and moisture.||
0374|242|R|Do not store in the bathroom. Keep all medications away from||
0374|243|R|children and pets.||
0374|244|R|   Do not flush medications down the toilet or pour them into a||
0374|245|R|drain unless instructed to do so. Properly discard this product||
0374|246|R|when it is expired or no longer needed. Consult your pharmacist||
0374|247|R|or local waste disposal company.||
0374|248|B|||
0374|249|A|Information last revised October 2025.||
0374|250|A|Copyright(c) 2025 First Databank, Inc.||
0374|251|B|||
0375|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0375|002|Z|does NOT have all possible information about this product. This||
0375|003|Z|information does not assure that this product is safe, effective,||
0375|004|Z|or appropriate for you. This information is not individual||
0375|005|Z|medical advice and does not substitute for the advice of your||
0375|006|Z|health care professional. Always ask your health care||
0375|007|Z|professional for complete information about this product and your||
0375|008|Z|specific health needs.||
0375|009|B|||
0375|010|T|DAPTOMYCIN - INJECTION||
0375|011|F|(DAP-toe-MYE-sin)||
0375|012|B|||
0375|013|C|COMMON BRAND NAME(S): Cubicin, Cubicin RF||
0375|014|B|||
0375|015|U|USES:  This medication is an antibiotic used to treat serious||
0375|016|U|bacterial infections. It works by stopping the growth of||
0375|017|U|bacteria.||
0375|018|U|   Daptomycin is not recommended for use in children younger than||
0375|019|U|12 months due to possible risk of serious side effects.||
0375|020|B|||
0375|021|H|HOW TO USE:  This medication is given by injection into a vein as||
0375|022|H|directed by your doctor, usually once daily. The dosage is based||
0375|023|H|on your weight, medical condition, and response to treatment.||
0375|024|H|Children's dosage is also based on age.||
0375|025|H|   If you are using this medication at home, learn all||
0375|026|H|preparation and usage instructions from your health care||
0375|027|H|professional. Before using, check this product for particles or||
0375|028|H|discoloration. If either is present, do not use the liquid. Learn||
0375|029|H|how to store and discard medical supplies safely.||
0375|030|H|   If you are using the frozen pre-mixed solution, thaw the||
0375|031|H|medication at room temperature or in the refrigerator. If the||
0375|032|H|container is thawed in the refrigerator, let it come to room||
0375|033|H|temperature before using. Do not thaw by putting in a water bath||
0375|034|H|or microwave. After thawing, shake well and squeeze the container||
0375|035|H|to check for leaks. Discard the solution if the container leaks.||
0375|036|H|Do not freeze it again after thawing.||
0375|037|H|   For the best effect, use this antibiotic at evenly spaced||
0375|038|H|times. To help you remember, use this medication at the same||
0375|039|H|time(s) every day.||
0375|040|H|   Continue to use this medication until the full prescribed||
0375|041|H|amount is finished, even if symptoms disappear after a few days.||
0375|042|H|Stopping the medication too early may result in a return of the||
0375|043|H|infection.||
0375|044|H|   Tell your doctor if your condition lasts or gets worse.||
0375|045|B|||
0375|046|S|SIDE EFFECTS:  Nausea, vomiting, constipation, diarrhea,||
0375|047|S|headache, dizziness, trouble sleeping, increased sweating, or||
0375|048|S|pain/redness/swelling at the injection site may occur. If any of||
0375|049|S|these effects last or get worse, tell your doctor or pharmacist||
0375|050|S|promptly.||
0375|051|S|   Remember that this medication has been prescribed because your||
0375|052|S|doctor has judged that the benefit to you is greater than the||
0375|053|S|risk of side effects. Many people using this medication do not||
0375|054|S|have serious side effects.||
0375|055|S|   Tell your doctor right away if you have any serious side||
0375|056|S|effects, including: muscle pain/tenderness/weakness, unusual||
0375|057|S|tiredness, signs of kidney problems (such as change in the amount||
0375|058|S|of urine), signs of a lung infection (such as cough, shortness of||
0375|059|S|breath, chest pain, new/unexplained fever), numbness/tingling of||
0375|060|S|arms/legs, swelling hands/ankles/feet, mental/mood changes (such||
0375|061|S|as anxiety).||
0375|062|S|   This medication may rarely cause a severe intestinal condition||
0375|063|S|due to a bacteria called C. difficile. This condition may occur||
0375|064|S|during treatment or weeks to months after treatment has stopped.||
0375|065|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0375|066|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0375|067|S|stool.||
0375|068|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0375|069|S|products because they may make symptoms worse.||
0375|070|S|   This medication may sometimes cause oral thrush or a new yeast||
0375|071|S|infection. Contact your doctor if you notice white patches in||
0375|072|S|your mouth, a change in vaginal discharge, or other new symptoms.||
0375|073|S|   A very serious allergic reaction to this drug is rare.||
0375|074|S|However, get medical help right away if you notice any symptoms||
0375|075|S|of a serious allergic reaction, including: fever that doesn't go||
0375|076|S|away, new or worsening lymph node swelling, rash, itching/severe||
0375|077|S|swelling (especially of the face/tongue/throat), severe||
0375|078|S|dizziness, trouble breathing.||
0375|079|S|   This is not a complete list of possible side effects. If you||
0375|080|S|notice other effects not listed above, contact your doctor or||
0375|081|S|pharmacist.||
0375|082|S|   In the US -||
0375|083|S|   Call your doctor for medical advice about side effects. You||
0375|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0375|085|S|www.fda.gov/medwatch.||
0375|086|S|   In Canada - Call your doctor for medical advice about side||
0375|087|S|effects. You may report side effects to Health Canada at||
0375|088|S|1-866-234-2345.||
0375|089|B|||
0375|090|P|PRECAUTIONS:  Before using daptomycin, tell your doctor or||
0375|091|P|pharmacist if you are allergic to it; or if you have any other||
0375|092|P|allergies. This product may contain inactive ingredients, which||
0375|093|P|can cause allergic reactions or other problems. Talk to your||
0375|094|P|pharmacist for more details.||
0375|095|P|   Before using this medication, tell your doctor or pharmacist||
0375|096|P|your medical history, especially of: kidney disease, muscle||
0375|097|P|problems (such as myopathy).||
0375|098|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0375|099|P|can make you more dizzy. Do not drive, use machinery, or do||
0375|100|P|anything that needs alertness until you can do it safely. Limit||
0375|101|P|alcoholic beverages. Talk to your doctor if you are using||
0375|102|P|marijuana (cannabis).||
0375|103|P|   Daptomycin may cause live bacterial vaccines (such as typhoid||
0375|104|P|vaccine) to not work well. Tell your health care professional||
0375|105|P|that you are using daptomycin before having any||
0375|106|P|immunizations/vaccinations.||
0375|107|P|   Before having surgery, tell your doctor or dentist about all||
0375|108|P|the products you use (including prescription drugs,||
0375|109|P|nonprescription drugs, and herbal products).||
0375|110|P|   Older adults may be more sensitive to the side effects of this||
0375|111|P|drug.||
0375|112|P|   During pregnancy, this medication should be used only when||
0375|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
0375|114|P|   This medication passes into breast milk in very small amounts.||
0375|115|P|Consult your doctor before breastfeeding.||
0375|116|B|||
0375|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0375|118|I|medications work or increase your risk for serious side effects.||
0375|119|I|This document does not contain all possible drug interactions.||
0375|120|I|Keep a list of all the products you use (including||
0375|121|I|prescription/nonprescription drugs and herbal products) and share||
0375|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
0375|123|I|the dosage of any medicines without your doctor's approval.||
0375|124|I|   Some products that may interact with this drug include:||
0375|125|I|"statin" cholesterol drugs (such as lovastatin, simvastatin).||
0375|126|I|   This medication may interfere with certain lab tests (such as||
0375|127|I|PT/INR test), possibly causing false test results. Make sure lab||
0375|128|I|personnel and all your doctors know you use this drug.||
0375|129|B|||
0375|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0375|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0375|132|O|poison control center right away. US residents can call||
0375|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0375|134|B|||
0375|135|N|NOTES:  Lab and/or medical tests (such as kidney function, CPK||
0375|136|N|levels) should be done while you are using this medication. Keep||
0375|137|N|all medical and lab appointments. Consult your doctor for more||
0375|138|N|details.||
0375|139|B|||
0375|140|D|MISSED DOSE:  It is important to get each dose of this medication||
0375|141|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0375|142|D|right away for a new dosing schedule. Do not double the dose to||
0375|143|D|catch up.||
0375|144|B|||
0375|145|R|STORAGE:  Consult the product instructions and your pharmacist||
0375|146|R|for storage details. Keep all medications away from children and||
0375|147|R|pets.||
0375|148|R|   Do not flush medications down the toilet or pour them into a||
0375|149|R|drain unless instructed to do so. Properly discard this product||
0375|150|R|when it is expired or no longer needed. Consult your pharmacist||
0375|151|R|or local waste disposal company.||
0375|152|B|||
0375|153|A|Information last revised December 2024.||
0375|154|A|Copyright(c) 2025 First Databank, Inc.||
0375|155|B|||
0377|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0377|002|Z|does NOT have all possible information about this product. This||
0377|003|Z|information does not assure that this product is safe, effective,||
0377|004|Z|or appropriate for you. This information is not individual||
0377|005|Z|medical advice and does not substitute for the advice of your||
0377|006|Z|health care professional. Always ask your health care||
0377|007|Z|professional for complete information about this product and your||
0377|008|Z|specific health needs.||
0377|009|B|||
0377|010|T|MEMANTINE - ORAL||
0377|011|F|(MEM-an-teen)||
0377|012|B|||
0377|013|C|COMMON BRAND NAME(S): Namenda||
0377|014|B|||
0377|015|U|USES:  Memantine is used to treat moderate to severe confusion||
0377|016|U|(dementia) related to Alzheimer's disease. It does not cure||
0377|017|U|Alzheimer's disease, but it may improve memory, awareness, and||
0377|018|U|the ability to perform daily functions. This medication works by||
0377|019|U|blocking the action of a certain natural substance in the brain||
0377|020|U|(glutamate) that is believed to be linked to symptoms of||
0377|021|U|Alzheimer's disease.||
0377|022|B|||
0377|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0377|024|H|from your pharmacist before you start taking memantine and each||
0377|025|H|time you get a refill. If you have any questions, ask your doctor||
0377|026|H|or pharmacist.||
0377|027|H|   Take this medication by mouth with or without food as directed||
0377|028|H|by your doctor, usually twice daily. The dosage is based on your||
0377|029|H|medical condition and response to treatment. When you first start||
0377|030|H|taking this medication, you will usually take it once daily. To||
0377|031|H|reduce your risk of side effects, your doctor may direct you to||
0377|032|H|start this medication at a low dose and gradually increase your||
0377|033|H|dose. Follow your doctor's instructions carefully.||
0377|034|H|   If you are taking memantine oral liquid, read the||
0377|035|H|manufacturer's instruction sheet that comes with the bottle.||
0377|036|H|Follow the directions exactly. Use the oral syringe that comes||
0377|037|H|with the product to measure out your dose. Do not use a household||
0377|038|H|spoon because you may not get the correct dose. Swallow the||
0377|039|H|medication directly from the syringe. Do not mix it with water or||
0377|040|H|other liquids. Rinse the syringe with water after each use.||
0377|041|H|Consult your doctor or pharmacist if you have any questions.||
0377|042|H|   Use this medication regularly to get the most benefit from it.||
0377|043|H|To help you remember, take it at the same time(s) each day.||
0377|044|H|   Tell your doctor if your condition gets worse.||
0377|045|B|||
0377|046|S|SIDE EFFECTS:  Body aches, dizziness, constipation, and headache||
0377|047|S|may occur. If any of these effects last or get worse, tell your||
0377|048|S|doctor or pharmacist promptly.||
0377|049|S|   Remember that this medication has been prescribed because your||
0377|050|S|doctor has judged that the benefit to you is greater than the||
0377|051|S|risk of side effects. Many people using this medication do not||
0377|052|S|have serious side effects.||
0377|053|S|   A very serious allergic reaction to this drug is rare.||
0377|054|S|However, get medical help right away if you notice any symptoms||
0377|055|S|of a serious allergic reaction, including: rash, itching/swelling||
0377|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0377|057|S|breathing.||
0377|058|S|   This is not a complete list of possible side effects. If you||
0377|059|S|notice other effects not listed above, contact your doctor or||
0377|060|S|pharmacist.||
0377|061|S|   In the US -||
0377|062|S|   Call your doctor for medical advice about side effects. You||
0377|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0377|064|S|www.fda.gov/medwatch.||
0377|065|S|   In Canada - Call your doctor for medical advice about side||
0377|066|S|effects. You may report side effects to Health Canada at||
0377|067|S|1-866-234-2345.||
0377|068|B|||
0377|069|P|PRECAUTIONS:  Before taking memantine, tell your doctor or||
0377|070|P|pharmacist if you are allergic to it; or if you have any other||
0377|071|P|allergies. This product may contain inactive ingredients which||
0377|072|P|can cause allergic reactions or other problems. Talk to your||
0377|073|P|pharmacist for more details.||
0377|074|P|   Before using this medication, tell your doctor or pharmacist||
0377|075|P|your medical history, especially of: kidney problems, severe||
0377|076|P|urinary tract infections, recent dietary change (from a||
0377|077|P|high-protein diet to a vegetarian diet).||
0377|078|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0377|079|P|can make you more dizzy. Do not drive, use machinery, or do||
0377|080|P|anything that needs alertness until you can do it safely. Limit||
0377|081|P|alcoholic beverages. Talk to your doctor if you are using||
0377|082|P|marijuana (cannabis).||
0377|083|P|   Before having surgery, tell your doctor or dentist about all||
0377|084|P|the products you use (including prescription drugs,||
0377|085|P|nonprescription drugs, and herbal products).||
0377|086|P|   During pregnancy, this medication should be used only when||
0377|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
0377|088|P|   It is unknown if this drug passes into breast milk. Consult||
0377|089|P|your doctor before breastfeeding.||
0377|090|B|||
0377|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0377|092|I|medications work or increase your risk for serious side effects.||
0377|093|I|This document does not contain all possible drug interactions.||
0377|094|I|Keep a list of all the products you use (including||
0377|095|I|prescription/nonprescription drugs and herbal products) and share||
0377|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
0377|097|I|the dosage of any medicines without your doctor's approval.||
0377|098|I|   Some products that may interact with this drug include:||
0377|099|I|carbonic anhydrase inhibitors (such as acetazolamide,||
0377|100|I|methazolamide), sodium bicarbonate.||
0377|101|B|||
0377|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0377|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0377|104|O|poison control center right away. US residents can call||
0377|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0377|106|O|Symptoms of overdose may include: restlessness, personality||
0377|107|O|change, hallucinations, drowsiness, loss of consciousness.||
0377|108|B|||
0377|109|N|NOTES:  Do not share this medication with others.||
0377|110|B|||
0377|111|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0377|112|D|remember. If it is near the time of the next dose, skip the||
0377|113|D|missed dose. Take your next dose at the regular time. Do not||
0377|114|D|double the dose to catch up.||
0377|115|D|   If you forget to take memantine for several days, talk to your||
0377|116|D|doctor before your next dose. You may need to start at a lower||
0377|117|D|dose again and slowly increase it.||
0377|118|B|||
0377|119|R|STORAGE:  Store at room temperature away from light and moisture.||
0377|120|R|Do not store in the bathroom. Keep all medications away from||
0377|121|R|children and pets.||
0377|122|R|   Do not flush medications down the toilet or pour them into a||
0377|123|R|drain unless instructed to do so. Properly discard this product||
0377|124|R|when it is expired or no longer needed. Consult your pharmacist||
0377|125|R|or local waste disposal company.||
0377|126|B|||
0377|127|A|Information last revised November 2024.||
0377|128|A|Copyright(c) 2025 First Databank, Inc.||
0377|129|B|||
0378|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0378|002|Z|does NOT have all possible information about this product. This||
0378|003|Z|information does not assure that this product is safe, effective,||
0378|004|Z|or appropriate for you. This information is not individual||
0378|005|Z|medical advice and does not substitute for the advice of your||
0378|006|Z|health care professional. Always ask your health care||
0378|007|Z|professional for complete information about this product and your||
0378|008|Z|specific health needs.||
0378|009|B|||
0378|010|T|ESTRADIOL VALERATE - INJECTION||
0378|011|F|(ES-tra-DYE-ol VAL-er-ate)||
0378|012|B|||
0378|013|C|COMMON BRAND NAME(S): Delestrogen||
0378|014|B|||
0378|015|W|WARNING:  Estrogens, either used alone or with another hormone||
0378|016|W|(progestin), have rarely caused very serious side effects.||
0378|017|W|Discuss the risks and benefits of hormone treatment with your||
0378|018|W|doctor. Estrogens should not be used to prevent heart disease or||
0378|019|W|dementia.||
0378|020|W|   Estrogens can increase the risk of cancer of the uterus||
0378|021|W|(endometrial cancer). Taking a progestin as directed by your||
0378|022|W|doctor can help decrease this risk. Tell your doctor right away||
0378|023|W|if you have any unusual vaginal bleeding.||
0378|024|W|   In postmenopausal women, estrogens, taken with or without a||
0378|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
0378|026|W|stroke, dementia, and serious blood clots. When used along with a||
0378|027|W|progestin, estrogens also increase the risk of heart disease||
0378|028|W|(such as heart attacks).||
0378|029|W|   The risk for serious side effects may depend on the dose of||
0378|030|W|estrogen and the length of time it is used. This medication||
0378|031|W|should be used at the lowest effective dose and for the shortest||
0378|032|W|amount of time. Discuss the use of this medication with your||
0378|033|W|doctor regularly (for example, every 3 to 6 months) to see if you||
0378|034|W|still need to use it. If you will be using this medication||
0378|035|W|long-term, you should have regular complete physical exams (for||
0378|036|W|example, once a year) as directed by your doctor. See also Notes||
0378|037|W|section.||
0378|038|B|||
0378|039|U|USES:  This medication is a hormone (estrogen). It is used by||
0378|040|U|women to help reduce symptoms of menopause (such as hot flashes,||
0378|041|U|vaginal dryness). These symptoms are caused by the body making||
0378|042|U|less estrogen. If you are using this medication to treat symptoms||
0378|043|U|only in and around the vagina, products applied directly inside||
0378|044|U|the vagina should be considered before medications that are taken||
0378|045|U|by mouth, absorbed through the skin, or injected. This medication||
0378|046|U|may also be used by women who are not able to produce enough||
0378|047|U|estrogen (for example, due to hypogonadism, primary ovarian||
0378|048|U|failure) and by men to treat prostate cancer.||
0378|049|B|||
0378|050|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0378|051|H|from your pharmacist before you start using this medication and||
0378|052|H|each time you get a refill. If you have any questions, ask your||
0378|053|H|doctor or pharmacist.||
0378|054|H|   This medication is injected into a muscle as directed by your||
0378|055|H|doctor, usually every 4 weeks. For the treatment of prostate||
0378|056|H|cancer, this medication is usually given every 1 to 2 weeks. The||
0378|057|H|dosage is based on your medical condition and response to||
0378|058|H|treatment.||
0378|059|H|   If you are using this medication at home, learn all||
0378|060|H|preparation and usage instructions from your health care||
0378|061|H|professional. Before using, check this product for particles or||
0378|062|H|discoloration. If either is present, do not use the liquid. If||
0378|063|H|stored at low temperatures, crystal may form in the liquid. To||
0378|064|H|dissolve these crystals, simply warm the product to room||
0378|065|H|temperature prior to use. Learn how to store and discard medical||
0378|066|H|supplies safely.||
0378|067|H|   Use this medication regularly to get the most benefit from it.||
0378|068|H|To help you remember, mark your calendar with a reminder.||
0378|069|H|   Tell your doctor if your condition does not get better or if||
0378|070|H|it gets worse.||
0378|071|B|||
0378|072|S|SIDE EFFECTS:  See also Warning section.||
0378|073|S|   Nausea/vomiting, bloating, breast tenderness, headache, or||
0378|074|S|weight changes may occur. If any of these effects last or get||
0378|075|S|worse, tell your doctor or pharmacist promptly.||
0378|076|S|   Remember that this medication has been prescribed because your||
0378|077|S|doctor has judged that the benefit to you is greater than the||
0378|078|S|risk of side effects. Many people using this medication do not||
0378|079|S|have serious side effects.||
0378|080|S|   Tell your doctor right away if you have any serious side||
0378|081|S|effects, including: nausea/vomiting that doesn't stop,||
0378|082|S|mental/mood changes (such as depression, memory loss), breast||
0378|083|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
0378|084|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
0378|085|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
0378|086|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
0378|087|S|increased thirst/urination.||
0378|088|S|   This medication may rarely cause serious (sometimes fatal)||
0378|089|S|problems from blood clots (such as heart attack, stroke, blood||
0378|090|S|clots in the lungs or legs). Get medical help right away if you||
0378|091|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
0378|092|S|headaches, weakness on one side of the body, confusion, trouble||
0378|093|S|speaking, sudden vision changes, pain/swelling/warmth in the||
0378|094|S|groin/calf, shortness of breath/rapid breathing, sudden||
0378|095|S|dizziness/fainting.||
0378|096|S|   A very serious allergic reaction to this drug is rare.||
0378|097|S|However, get medical help right away if you notice any symptoms||
0378|098|S|of a serious allergic reaction, including: rash, itching/swelling||
0378|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0378|100|S|breathing.||
0378|101|S|   This is not a complete list of possible side effects. If you||
0378|102|S|notice other effects not listed above, contact your doctor or||
0378|103|S|pharmacist.||
0378|104|S|   In the US -||
0378|105|S|   Call your doctor for medical advice about side effects. You||
0378|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0378|107|S|www.fda.gov/medwatch.||
0378|108|S|   In Canada - Call your doctor for medical advice about side||
0378|109|S|effects. You may report side effects to Health Canada at||
0378|110|S|1-866-234-2345.||
0378|111|B|||
0378|112|P|PRECAUTIONS:  Before using estradiol valerate, tell your doctor||
0378|113|P|or pharmacist if you are allergic to it; or if you have any other||
0378|114|P|allergies. This product may contain inactive ingredients, which||
0378|115|P|can cause allergic reactions or other problems. Talk to your||
0378|116|P|pharmacist for more details.||
0378|117|P|   Before using this medication, tell your doctor or pharmacist||
0378|118|P|your medical history, especially of: vaginal bleeding of unknown||
0378|119|P|cause, certain cancers (such as breast cancer, cancer of the||
0378|120|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
0378|121|P|heart attack), liver disease, kidney disease, family medical||
0378|122|P|history (especially breast lumps, cancer, blood clots), family or||
0378|123|P|personal history of a certain swelling disorder (angioedema),||
0378|124|P|blood clotting disorders (such as protein C or protein S||
0378|125|P|deficiency), high blood pressure, diabetes, high blood||
0378|126|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
0378|127|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
0378|128|P|calcium in the blood), a certain hormone problem||
0378|129|P|(hypoparathyroidism), uterus problems (such as fibroids,||
0378|130|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
0378|131|P|headaches, a certain blood disorder (porphyria), mental/mood||
0378|132|P|disorders (such as dementia, depression).||
0378|133|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
0378|134|P|further increases your risk of stroke, blood clots, high blood||
0378|135|P|pressure, and heart attack, especially in women older than 35.||
0378|136|P|   Tell your doctor if you just had or will be having surgery, or||
0378|137|P|if you will be confined to a chair or bed for a long time (such||
0378|138|P|as a long plane flight). These conditions increase your risk of||
0378|139|P|getting blood clots, especially if you are using an estrogen||
0378|140|P|product. You may need to stop this medication for a time or take||
0378|141|P|special precautions.||
0378|142|P|   This medication may cause blotchy, dark areas on your face and||
0378|143|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0378|144|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0378|145|P|wear protective clothing when outdoors.||
0378|146|P|   If you are nearsighted or wear contact lenses, you may develop||
0378|147|P|vision problems or trouble wearing your contact lenses. Contact||
0378|148|P|your eye doctor if these problems occur.||
0378|149|P|   Children may be more sensitive to the side effects of this||
0378|150|P|drug. It may affect their growth/development. Discuss the||
0378|151|P|possible effects of this medication with the doctor, and monitor||
0378|152|P|your child's growth periodically.||
0378|153|P|   This medication should not be used during pregnancy. If you||
0378|154|P|become pregnant or think you may be pregnant, tell your doctor||
0378|155|P|right away.||
0378|156|P|   This medication passes into breast milk. Consult your doctor||
0378|157|P|before breastfeeding.||
0378|158|B|||
0378|159|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0378|160|I|medications work or increase your risk for serious side effects.||
0378|161|I|This document does not contain all possible drug interactions.||
0378|162|I|Keep a list of all the products you use (including||
0378|163|I|prescription/nonprescription drugs and herbal products) and share||
0378|164|I|it with your doctor and pharmacist. Do not start, stop, or change||
0378|165|I|the dosage of any medicines without your doctor's approval.||
0378|166|I|   Some products that may interact with this drug include:||
0378|167|I|aromatase inhibitors (such as anastrozole, exemestane,||
0378|168|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
0378|169|I|tamoxifen, toremifene, tranexamic acid.||
0378|170|I|   This medication may interfere with certain lab tests (such as||
0378|171|I|metyrapone test), possibly causing false test results. Make sure||
0378|172|I|lab personnel and all your doctors know you use this drug.||
0378|173|B|||
0378|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0378|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0378|176|O|poison control center right away. US residents can call||
0378|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0378|178|O|Symptoms of overdose may include: severe nausea/vomiting, unusual||
0378|179|O|vaginal bleeding.||
0378|180|B|||
0378|181|N|NOTES:  Do not share this medication with others.||
0378|182|N|   Regular complete physical exams which include lab and/or||
0378|183|N|medical tests (such as blood pressure, breast exam/mammogram,||
0378|184|N|pelvic exam, Pap smear) should be done while you are using this||
0378|185|N|medication. Follow your doctor's instructions for examining your||
0378|186|N|breasts, and report any lumps right away. Keep all medical and||
0378|187|N|lab appointments. Consult your doctor for more details.||
0378|188|N|   Preventing or controlling high blood pressure, high||
0378|189|N|cholesterol, and diabetes can help to reduce your chances of||
0378|190|N|heart disease and stroke. Lifestyle changes that can help to||
0378|191|N|control or prevent these diseases include reducing stress, eating||
0378|192|N|a low fat/salt diet, losing weight if overweight, exercising||
0378|193|N|regularly, and stopping smoking. Keep your mind active with||
0378|194|N|mental exercises (such as reading, solving crossword puzzles) to||
0378|195|N|help prevent dementia. Talk to your doctor about lifestyle||
0378|196|N|changes that might benefit you.||
0378|197|N|   Lifestyle changes that may help reduce hot flashes include||
0378|198|N|stopping smoking, dressing lightly or in layers,||
0378|199|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
0378|200|N|reducing stress, and exercising regularly.||
0378|201|B|||
0378|202|D|MISSED DOSE:  It is important to get each dose of this medication||
0378|203|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0378|204|D|right away for a new dosing schedule. Do not double the dose to||
0378|205|D|catch up.||
0378|206|B|||
0378|207|R|STORAGE:  Store at room temperature. Keep all medications away||
0378|208|R|from children and pets.||
0378|209|R|   Do not flush medications down the toilet or pour them into a||
0378|210|R|drain unless instructed to do so. Properly discard this product||
0378|211|R|when it is expired or no longer needed. Consult your pharmacist||
0378|212|R|or local waste disposal company.||
0378|213|B|||
0378|214|A|Information last revised December 2024.||
0378|215|A|Copyright(c) 2025 First Databank, Inc.||
0378|216|B|||
0380|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0380|002|Z|does NOT have all possible information about this product. This||
0380|003|Z|information does not assure that this product is safe, effective,||
0380|004|Z|or appropriate for you. This information is not individual||
0380|005|Z|medical advice and does not substitute for the advice of your||
0380|006|Z|health care professional. Always ask your health care||
0380|007|Z|professional for complete information about this product and your||
0380|008|Z|specific health needs.||
0380|009|B|||
0380|010|T|TIOTROPIUM POWDER IN CAPSULE - INHALATION||
0380|011|F|(TYE-oh-TROE-pee-um)||
0380|012|B|||
0380|013|C|COMMON BRAND NAME(S): Spiriva||
0380|014|B|||
0380|015|U|USES:  Tiotropium is used to control and prevent symptoms (such||
0380|016|U|as wheezing, shortness of breath) caused by ongoing lung disease||
0380|017|U|(chronic obstructive pulmonary disease-COPD which includes||
0380|018|U|bronchitis and emphysema). It works by relaxing the muscles||
0380|019|U|around the airways so that they open up and you can breathe more||
0380|020|U|easily. Tiotropium belongs to a class of drugs known as||
0380|021|U|anticholinergics. Controlling symptoms of breathing problems can||
0380|022|U|decrease time lost from work or school.||
0380|023|U|   This medication must be used regularly to be effective. It||
0380|024|U|does not work right away and should not be used to relieve sudden||
0380|025|U|breathing problems. If wheezing or sudden shortness of breath||
0380|026|U|occurs, use your quick-relief inhaler (such as albuterol, also||
0380|027|U|called salbutamol in some countries) as prescribed.||
0380|028|B|||
0380|029|H|HOW TO USE:  Read the Patient Information Leaflet and||
0380|030|H|Instructions for Use provided by your pharmacist before you start||
0380|031|H|using this medication and each time you get a refill. Follow the||
0380|032|H|illustrated directions for the proper use of this medication. If||
0380|033|H|you have any questions, ask your doctor or pharmacist.||
0380|034|H|   Do not swallow these capsules by mouth. Use the special||
0380|035|H|inhaler to inhale the powder in the capsules. Inhale this||
0380|036|H|medication by mouth as directed by your doctor, usually once||
0380|037|H|daily. Inhale 2 times per capsule to make sure you inhale all of||
0380|038|H|the drug. Do not breathe out into the mouthpiece at any time.||
0380|039|H|Avoid getting this medication into your eyes. It may cause eye||
0380|040|H|pain/irritation, temporary blurred vision, and other vision||
0380|041|H|changes.||
0380|042|H|   If you are using other inhalers at the same time, wait at||
0380|043|H|least 1 minute between the use of each medication.||
0380|044|H|   Use this medication regularly in order to get the most benefit||
0380|045|H|from it. This medication works best if used at evenly spaced||
0380|046|H|intervals. To help you remember, use it at the same time each||
0380|047|H|day. Do not increase your dose, use this medication more often,||
0380|048|H|or stop using it without first consulting your doctor.||
0380|049|H|   Rinse your mouth after using the inhaler to prevent dry mouth||
0380|050|H|and throat irritation.||
0380|051|H|   Clean the inhaler at least once a month with water. Allow to||
0380|052|H|air-dry fully before using again.||
0380|053|H|   Learn which of your inhalers you should use every day and||
0380|054|H|which you should use if your breathing suddenly worsens||
0380|055|H|(quick-relief drugs). Ask your doctor ahead of time what you||
0380|056|H|should do if you have new or worsening cough or shortness of||
0380|057|H|breath, wheezing, increased sputum, waking up at night with||
0380|058|H|trouble breathing, if you use your quick-relief inhaler more||
0380|059|H|often, or if your quick-relief inhaler does not seem to be||
0380|060|H|working well. Learn when you can treat sudden breathing problems||
0380|061|H|by yourself and when you must get medical help right away.||
0380|062|H|   Tell your doctor if your symptoms do not get better or if they||
0380|063|H|get worse.||
0380|064|B|||
0380|065|S|SIDE EFFECTS:  Dry mouth, constipation, or dizziness may occur.||
0380|066|S|If any of these effects last or get worse, tell your doctor or||
0380|067|S|pharmacist promptly.||
0380|068|S|   Remember that this medication has been prescribed because your||
0380|069|S|doctor has judged that the benefit to you is greater than the||
0380|070|S|risk of side effects. Many people using this medication do not||
0380|071|S|have serious side effects.||
0380|072|S|   Rarely, this medication may cause severe sudden worsening of||
0380|073|S|breathing problems right after use. If you have sudden worsening||
0380|074|S|of breathing, use your quick-relief inhaler and get medical help||
0380|075|S|right away.||
0380|076|S|   Tell your doctor right away if you have any serious side||
0380|077|S|effects, including: difficult/painful urination, fast heartbeat.||
0380|078|S|   Get medical help right away if you have any very serious side||
0380|079|S|effects, including: eye pain/swelling/redness, vision changes||
0380|080|S|(such as seeing rainbows around lights at night, blurred vision).||
0380|081|S|   A very serious allergic reaction to this product is rare.||
0380|082|S|However, get medical help right away if you notice any symptoms||
0380|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0380|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0380|085|S|breathing.||
0380|086|S|   This is not a complete list of possible side effects. If you||
0380|087|S|notice other effects not listed above, contact your doctor or||
0380|088|S|pharmacist.||
0380|089|S|   In the US -||
0380|090|S|   Call your doctor for medical advice about side effects. You||
0380|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0380|092|S|www.fda.gov/medwatch.||
0380|093|S|   In Canada - Call your doctor for medical advice about side||
0380|094|S|effects. You may report side effects to Health Canada at||
0380|095|S|1-866-234-2345.||
0380|096|B|||
0380|097|P|PRECAUTIONS:  Before using tiotropium, tell your doctor or||
0380|098|P|pharmacist if you are allergic to it or to ipratropium; or to||
0380|099|P|atropine or other belladonna-type drugs; or if you have any other||
0380|100|P|allergies. This product may contain inactive ingredients (such as||
0380|101|P|milk proteins), which can cause allergic reactions or other||
0380|102|P|problems. Talk to your pharmacist for more details.||
0380|103|P|   Before using this medication, tell your doctor or pharmacist||
0380|104|P|your medical history, especially of: kidney disease, personal or||
0380|105|P|family history of glaucoma (angle-closure type), difficulty||
0380|106|P|urinating (for example, due to enlarged prostate).||
0380|107|P|   This drug may make you dizzy or blur your vision. Alcohol or||
0380|108|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
0380|109|P|machinery, or do anything that needs alertness or clear vision||
0380|110|P|until you can do it safely. Limit alcoholic beverages. Talk to||
0380|111|P|your doctor if you are using marijuana (cannabis).||
0380|112|P|   Before having surgery, tell your doctor or dentist about all||
0380|113|P|the products you use (including prescription drugs,||
0380|114|P|nonprescription drugs, and herbal products).||
0380|115|P|   Older adults may be more sensitive to the side effects of this||
0380|116|P|drug, especially dry mouth and constipation. Older men may also||
0380|117|P|be at greater risk for difficulty urinating while using this||
0380|118|P|drug.||
0380|119|P|   During pregnancy, this medication should be used only when||
0380|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
0380|121|P|   It is unknown if this medication passes into breast milk.||
0380|122|P|Consult your doctor before breastfeeding.||
0380|123|B|||
0380|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0380|125|I|medications work or increase your risk for serious side effects.||
0380|126|I|This document does not contain all possible drug interactions.||
0380|127|I|Keep a list of all the products you use (including||
0380|128|I|prescription/nonprescription drugs and herbal products) and share||
0380|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
0380|130|I|the dosage of any medicines without your doctor's approval.||
0380|131|B|||
0380|132|O|OVERDOSE:  This medication will not work and may be harmful if||
0380|133|O|swallowed. If someone has overdosed and has serious symptoms such||
0380|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0380|135|O|poison control center right away. US residents can call||
0380|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0380|137|B|||
0380|138|N|NOTES:  Do not share this medication with others.||
0380|139|B|||
0380|140|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0380|141|D|If it is near the time of the next dose, skip the missed dose.||
0380|142|D|Use your next dose at the regular time. Do not double the dose to||
0380|143|D|catch up.||
0380|144|B|||
0380|145|R|STORAGE:  Store the capsules at room temperature away from light||
0380|146|R|and moisture. Do not store in the bathroom. Keep the capsules in||
0380|147|R|the original blister packaging until ready to use. Do not store||
0380|148|R|capsules in the inhaler device. Once the blister package for a||
0380|149|R|capsule is opened, use the capsule right away. Discard any||
0380|150|R|capsule that has its blister package opened and not used right||
0380|151|R|away. Keep all medications away from children and pets.||
0380|152|R|   Do not flush medications down the toilet or pour them into a||
0380|153|R|drain unless instructed to do so. Properly discard this product||
0380|154|R|when it is expired or no longer needed. Consult your pharmacist||
0380|155|R|or local waste disposal company.||
0380|156|B|||
0380|157|M|MEDICAL ALERT:  Your condition can cause complications in a||
0380|158|M|medical emergency. For information about enrolling in MedicAlert,||
0380|159|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0380|160|B|||
0380|161|A|Information last revised July 2025.||
0380|162|A|Copyright(c) 2025 First Databank, Inc.||
0380|163|B|||
0381|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0381|002|Z|does NOT have all possible information about this product. This||
0381|003|Z|information does not assure that this product is safe, effective,||
0381|004|Z|or appropriate for you. This information is not individual||
0381|005|Z|medical advice and does not substitute for the advice of your||
0381|006|Z|health care professional. Always ask your health care||
0381|007|Z|professional for complete information about this product and your||
0381|008|Z|specific health needs.||
0381|009|B|||
0381|010|T|SODIUM FLUORIDE 1.1% TOOTHPASTE - DENTAL||
0381|011|F|(SOE-dee-um FLOOR-ide)||
0381|012|B|||
0381|013|C|COMMON BRAND NAME(S): Prevident||
0381|014|B|||
0381|015|U|USES:  Sodium fluoride makes teeth more resistant to decay and||
0381|016|U|bacteria that cause cavities. This medication is used to prevent||
0381|017|U|cavities.||
0381|018|B|||
0381|019|H|HOW TO USE:  Use this medication as directed by your||
0381|020|H|doctor/dentist, usually once daily just before bedtime instead of||
0381|021|H|your regular toothpaste.||
0381|022|H|   Apply a thin ribbon of medicine to a toothbrush and brush||
0381|023|H|thoroughly for 2 minutes or as directed.||
0381|024|H|   Spit out the medication after use. Do not swallow. Children||
0381|025|H|should rinse their mouth thoroughly right away. For adults, do||
0381|026|H|not rinse your mouth, eat, or drink for at least 30 minutes after||
0381|027|H|use to get the best results.||
0381|028|B|||
0381|029|S|SIDE EFFECTS:  Mouth/gum irritation may rarely occur. If this||
0381|030|S|effect lasts or gets worse, tell your doctor/dentist or||
0381|031|S|pharmacist promptly.||
0381|032|S|   Tell your doctor/dentist right away if your teeth become||
0381|033|S|stained or pitted. This is often a result of too much fluoride.||
0381|034|S|   Remember that this medication has been prescribed because your||
0381|035|S|doctor has judged that the benefit to you is greater than the||
0381|036|S|risk of side effects. Many people using this medication do not||
0381|037|S|have serious side effects.||
0381|038|S|   A very serious allergic reaction to this drug is rare.||
0381|039|S|However, get medical help right away if you notice any symptoms||
0381|040|S|of a serious allergic reaction, including: rash, itching/swelling||
0381|041|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0381|042|S|breathing.||
0381|043|S|   This is not a complete list of possible side effects. If you||
0381|044|S|notice other effects not listed above, contact your dentist or||
0381|045|S|pharmacist.||
0381|046|S|   In the US -||
0381|047|S|   Call your doctor for medical advice about side effects. You||
0381|048|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0381|049|S|www.fda.gov/medwatch.||
0381|050|S|   In Canada - Call your doctor for medical advice about side||
0381|051|S|effects. You may report side effects to Health Canada at||
0381|052|S|1-866-234-2345.||
0381|053|B|||
0381|054|P|PRECAUTIONS:  Before using sodium fluoride, tell your healthcare||
0381|055|P|professional if you are allergic to it; or if you have any other||
0381|056|P|allergies. This product may contain inactive ingredients, which||
0381|057|P|can cause allergic reactions or other problems. Talk to your||
0381|058|P|pharmacist for more details.||
0381|059|P|   Before using this medication, tell your doctor/dentist or||
0381|060|P|pharmacist your medical history, especially of: mouth problems||
0381|061|P|(such as sores, mucositis).||
0381|062|P|   Children may be more sensitive to the side effects of this||
0381|063|P|drug, especially if this medication is swallowed. Watch children||
0381|064|P|closely when they are using this medication to make sure that||
0381|065|P|they do not swallow this medication.||
0381|066|P|   Before using this medicine, tell your healthcare professional||
0381|067|P|if you are pregnant.||
0381|068|P|   It is unknown if this drug passes into breast milk. Consult||
0381|069|P|your healthcare professional before breastfeeding.||
0381|070|B|||
0381|071|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0381|072|I|medications work or increase your risk for serious side effects.||
0381|073|I|This document does not contain all possible drug interactions.||
0381|074|I|Keep a list of all the products you use (including||
0381|075|I|prescription/nonprescription drugs and herbal products) and share||
0381|076|I|it with your doctor and pharmacist. Do not start, stop, or change||
0381|077|I|the dosage of any medicines without your doctor's approval.||
0381|078|B|||
0381|079|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0381|080|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0381|081|O|poison control center right away. US residents can call||
0381|082|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0381|083|O|Symptoms of overdose may include: nausea, vomiting, excess||
0381|084|O|saliva, stomach pain, diarrhea, "coffee ground" vomit, burning||
0381|085|O|sensation in the mouth or sore tongue.||
0381|086|B|||
0381|087|N|NOTES:  Keep regular dental appointments.||
0381|088|B|||
0381|089|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0381|090|D|If it is near the time of the next dose, skip the missed dose.||
0381|091|D|Use your next dose at the regular time. Do not double the dose to||
0381|092|D|catch up.||
0381|093|B|||
0381|094|R|STORAGE:  Store at room temperature away from heat. Keep all||
0381|095|R|medications away from children and pets.||
0381|096|R|   Do not flush medications down the toilet or pour them into a||
0381|097|R|drain unless instructed to do so. Properly discard this product||
0381|098|R|when it is expired or no longer needed. Consult your pharmacist||
0381|099|R|or local waste disposal company.||
0381|100|B|||
0381|101|A|Information last revised May 2024.||
0381|102|A|Copyright(c) 2025 First Databank, Inc.||
0381|103|B|||
0382|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0382|002|Z|does NOT have all possible information about this product. This||
0382|003|Z|information does not assure that this product is safe, effective,||
0382|004|Z|or appropriate for you. This information is not individual||
0382|005|Z|medical advice and does not substitute for the advice of your||
0382|006|Z|health care professional. Always ask your health care||
0382|007|Z|professional for complete information about this product and your||
0382|008|Z|specific health needs.||
0382|009|B|||
0382|010|T|EPINASTINE - OPHTHALMIC||
0382|011|F|(EP-i-NAS-teen)||
0382|012|B|||
0382|013|C|COMMON BRAND NAME(S): Elestat||
0382|014|B|||
0382|015|U|USES:  This medication is an antihistamine used to prevent||
0382|016|U|itching of the eyes caused by allergies (allergic||
0382|017|U|conjunctivitis).||
0382|018|B|||
0382|019|H|HOW TO USE:  Use this medication in both eyes as directed by your||
0382|020|H|doctor, usually twice daily. Use should continue during times||
0382|021|H|when you may be exposed to the agents (such as allergens,||
0382|022|H|pollens) that can cause allergies, even if your eyes are not||
0382|023|H|irritated or itchy.||
0382|024|H|   If you wear contact lenses, remove them before applying this||
0382|025|H|medication. Wait at least 10 minutes after using the drops before||
0382|026|H|wearing your lenses again.||
0382|027|H|   To apply eye drops, wash your hands first. To avoid||
0382|028|H|contamination, do not touch the dropper tip or let it touch your||
0382|029|H|eye or any other surface.||
0382|030|H|   Tilt your head back, look upward and pull down the lower||
0382|031|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0382|032|H|and instill the prescribed number of drops. Look downward and||
0382|033|H|gently close your eye for 1 to 2 minutes. Place one finger at the||
0382|034|H|inside corner of the eye and apply gentle pressure to prevent the||
0382|035|H|medication from draining out. Try not to blink and do not rub||
0382|036|H|your eye.||
0382|037|H|   Do not rinse the dropper. Replace the dropper cap after each||
0382|038|H|use.||
0382|039|H|   If you are using another kind of eye medication (such as drops||
0382|040|H|or ointments), wait at least 10 minutes before applying other||
0382|041|H|medications. Use eye drops before eye ointments to allow the eye||
0382|042|H|drops to enter the eye.||
0382|043|H|   Wait several minutes for your vision to clear before driving||
0382|044|H|or operating machinery.||
0382|045|B|||
0382|046|S|SIDE EFFECTS:  Burning/redness of the eye or headache may occur.||
0382|047|S|If any of these effects last or get worse, tell your doctor or||
0382|048|S|pharmacist promptly.||
0382|049|S|   Remember that this medication has been prescribed because your||
0382|050|S|doctor has judged that the benefit to you is greater than the||
0382|051|S|risk of side effects. Many people using this medication do not||
0382|052|S|have serious side effects.||
0382|053|S|   A very serious allergic reaction to this drug is rare.||
0382|054|S|However, get medical help right away if you notice any symptoms||
0382|055|S|of a serious allergic reaction, including: rash, itching/swelling||
0382|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0382|057|S|breathing.||
0382|058|S|   This is not a complete list of possible side effects. If you||
0382|059|S|notice other effects not listed above, contact your doctor or||
0382|060|S|pharmacist.||
0382|061|S|   In the US -||
0382|062|S|   Call your doctor for medical advice about side effects. You||
0382|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0382|064|S|www.fda.gov/medwatch.||
0382|065|S|   In Canada - Call your doctor for medical advice about side||
0382|066|S|effects. You may report side effects to Health Canada at||
0382|067|S|1-866-234-2345.||
0382|068|B|||
0382|069|P|PRECAUTIONS:  Before using epinastine, tell your doctor or||
0382|070|P|pharmacist if you are allergic to it; or if you have any other||
0382|071|P|allergies. This product may contain inactive ingredients, which||
0382|072|P|can cause allergic reactions or other problems. Talk to your||
0382|073|P|pharmacist for more details.||
0382|074|P|   Before using this medication, tell your doctor or pharmacist||
0382|075|P|your medical history.||
0382|076|P|   If you wear contact lenses, consult your doctor about the use||
0382|077|P|of contact lenses when the eyes are red or irritated.||
0382|078|P|   After you apply this drug, your vision may become temporarily||
0382|079|P|blurred. Do not drive, use machinery, or do anything that needs||
0382|080|P|clear vision until you can do it safely.||
0382|081|P|   During pregnancy, this medication should be used only when||
0382|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
0382|083|P|   It is unknown if this drug passes into breast milk. Consult||
0382|084|P|your doctor before breastfeeding.||
0382|085|B|||
0382|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0382|087|I|medications work or increase your risk for serious side effects.||
0382|088|I|This document does not contain all possible drug interactions.||
0382|089|I|Keep a list of all the products you use (including||
0382|090|I|prescription/nonprescription drugs and herbal products) and share||
0382|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
0382|092|I|the dosage of any medicines without your doctor's approval.||
0382|093|B|||
0382|094|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0382|095|O|has overdosed and has serious symptoms such as passing out or||
0382|096|O|trouble breathing, call 911. Otherwise, call a poison control||
0382|097|O|center right away. US residents can call 1-800-222-1222. Canada||
0382|098|O|residents can call 1-844-764-7669.||
0382|099|B|||
0382|100|N|NOTES:  Do not share this medication with others.||
0382|101|B|||
0382|102|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0382|103|D|If it is near the time of the next dose, skip the missed dose.||
0382|104|D|Use your next dose at the regular time. Do not double the dose to||
0382|105|D|catch up.||
0382|106|B|||
0382|107|R|STORAGE:  Store at room temperature. Keep all medications away||
0382|108|R|from children and pets.||
0382|109|R|   Do not flush medications down the toilet or pour them into a||
0382|110|R|drain unless instructed to do so. Properly discard this product||
0382|111|R|when it is expired or no longer needed. Consult your pharmacist||
0382|112|R|or local waste disposal company.||
0382|113|B|||
0382|114|A|Information last revised May 2024.||
0382|115|A|Copyright(c) 2025 First Databank, Inc.||
0382|116|B|||
0383|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0383|002|Z|does NOT have all possible information about this product. This||
0383|003|Z|information does not assure that this product is safe, effective,||
0383|004|Z|or appropriate for you. This information is not individual||
0383|005|Z|medical advice and does not substitute for the advice of your||
0383|006|Z|health care professional. Always ask your health care||
0383|007|Z|professional for complete information about this product and your||
0383|008|Z|specific health needs.||
0383|009|B|||
0383|010|T|PREDNISONE CONCENTRATE SOLUTION - ORAL||
0383|011|F|(PRED-ni-sone)||
0383|012|B|||
0383|013|C|COMMON BRAND NAME(S): Prednisone Intensol||
0383|014|B|||
0383|015|U|USES:  Prednisone is used to treat conditions such as arthritis,||
0383|016|U|blood disorders, breathing problems, severe allergies, skin||
0383|017|U|diseases, cancer, eye problems, and immune system disorders.||
0383|018|U|Prednisone belongs to a class of drugs known as corticosteroids.||
0383|019|U|It decreases your immune system's response to various diseases to||
0383|020|U|reduce symptoms such as swelling and allergic-type reactions.||
0383|021|B|||
0383|022|V|OTHER USES:  This section contains uses of this drug that are not||
0383|023|V|listed in the approved professional labeling for the drug but||
0383|024|V|that may be prescribed by your health care professional. Use this||
0383|025|V|drug for a condition that is listed in this section only if it||
0383|026|V|has been so prescribed by your health care professional.||
0383|027|V|   Prednisone may also be used for COVID-19, but is only||
0383|028|V|effective in hospitalized patients who need supplemental oxygen||
0383|029|V|or a mechanical ventilator to breathe.||
0383|030|B|||
0383|031|H|HOW TO USE:  Take this medication by mouth, with food or milk to||
0383|032|H|prevent stomach upset, as directed by your doctor. Carefully||
0383|033|H|measure the dose using the dropper that comes with your||
0383|034|H|medication. Do not use a household spoon because you may not get||
0383|035|H|the correct dose. You may mix the medication in juice or||
0383|036|H|applesauce before taking it. If you are prescribed only one dose||
0383|037|H|per day, take it in the morning before 9 A.M.||
0383|038|H|   Take this medication exactly as directed by your doctor.||
0383|039|H|Follow the dosing schedule carefully. The dosage and length of||
0383|040|H|treatment are based on your medical condition and response to||
0383|041|H|treatment. If you are taking this medication on a different||
0383|042|H|schedule than a daily one (such as every other day), it may help||
0383|043|H|to mark your calendar with a reminder.||
0383|044|H|   Do not stop taking this medication without consulting your||
0383|045|H|doctor. Some conditions may become worse when this drug is||
0383|046|H|suddenly stopped. Also, you may experience symptoms such as||
0383|047|H|weakness, weight loss, nausea, muscle pain, headache, tiredness,||
0383|048|H|dizziness. To prevent these symptoms while you are stopping||
0383|049|H|treatment with this drug, your doctor may reduce your dose||
0383|050|H|gradually. Consult your doctor or pharmacist for more details.||
0383|051|H|Report any new or worsening symptoms right away.||
0383|052|H|   Tell your doctor if your condition lasts or gets worse.||
0383|053|B|||
0383|054|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, heartburn,||
0383|055|S|trouble sleeping, increased sweating, or acne may occur. If any||
0383|056|S|of these effects last or get worse, tell your doctor or||
0383|057|S|pharmacist promptly.||
0383|058|S|   Remember that this medication has been prescribed because your||
0383|059|S|doctor has judged that the benefit to you is greater than the||
0383|060|S|risk of side effects. Many people using this medication do not||
0383|061|S|have serious side effects.||
0383|062|S|   Tell your doctor right away if you have any serious side||
0383|063|S|effects, including: muscle pain/cramps, irregular heartbeat,||
0383|064|S|weakness, swelling hands/ankles/feet, unusual weight gain, signs||
0383|065|S|of infection (such as sore throat that doesn't go away, fever,||
0383|066|S|chills), vision problems (such as blurred vision), symptoms of||
0383|067|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
0383|068|S|black/tarry stools, vomit that looks like coffee grounds),||
0383|069|S|mental/mood changes (such as depression, mood swings, agitation),||
0383|070|S|slow wound healing, thinning skin, bone pain, menstrual period||
0383|071|S|changes, puffy face, seizures, easy bruising/bleeding, red/purple||
0383|072|S|spots on the skin.||
0383|073|S|   This medication may rarely make your blood sugar rise, which||
0383|074|S|can cause or worsen diabetes. Tell your doctor right away if you||
0383|075|S|have symptoms of high blood sugar, such as increased||
0383|076|S|thirst/urination. If you already have diabetes, check your blood||
0383|077|S|sugar regularly as directed and share the results with your||
0383|078|S|doctor. Your doctor may need to adjust your diabetes medication,||
0383|079|S|exercise program, or diet.||
0383|080|S|   A very serious allergic reaction to this product is rare.||
0383|081|S|However, get medical help right away if you notice any symptoms||
0383|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0383|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0383|084|S|breathing.||
0383|085|S|   This is not a complete list of possible side effects. If you||
0383|086|S|notice other effects not listed above, contact your doctor or||
0383|087|S|pharmacist.||
0383|088|S|   In the US -||
0383|089|S|   Call your doctor for medical advice about side effects. You||
0383|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0383|091|S|www.fda.gov/medwatch.||
0383|092|S|   In Canada - Call your doctor for medical advice about side||
0383|093|S|effects. You may report side effects to Health Canada at||
0383|094|S|1-866-234-2345.||
0383|095|B|||
0383|096|P|PRECAUTIONS:  Before taking prednisone, tell your doctor or||
0383|097|P|pharmacist if you are allergic to it; or if you have any other||
0383|098|P|allergies. This product may contain inactive ingredients, which||
0383|099|P|can cause allergic reactions or other problems. Talk to your||
0383|100|P|pharmacist for more details.||
0383|101|P|   Before using this medication, tell your doctor or pharmacist||
0383|102|P|your medical history, especially of: current/past infections||
0383|103|P|(such as fungal infections, tuberculosis, herpes), heart problems||
0383|104|P|(such as heart failure, recent heart attack), high blood||
0383|105|P|pressure, thyroid problems, kidney disease, liver disease (such||
0383|106|P|as hepatitis B), stomach/intestinal problems (such as ulcer,||
0383|107|P|diverticulitis), bone loss (osteoporosis), mental/mood disorders||
0383|108|P|(such as psychosis, anxiety, depression), eye diseases (such as||
0383|109|P|cataracts, glaucoma), diabetes, mineral imbalance (such as low||
0383|110|P|level of potassium/calcium in the blood), seizures, blood clots,||
0383|111|P|bleeding problems, a certain adrenal gland tumor||
0383|112|P|(pheochromocytoma).||
0383|113|P|   Using corticosteroid medications for a long time can make it||
0383|114|P|more difficult for your body to respond to physical stress.||
0383|115|P|Before having surgery or emergency treatment, or if you get a||
0383|116|P|serious illness/injury, tell your doctor or dentist that you are||
0383|117|P|using this medication or have used this medication within the||
0383|118|P|past 12 months. Tell your doctor right away if you develop||
0383|119|P|unusual/extreme tiredness or weight loss. If you will be using||
0383|120|P|this medication for a long time, carry a warning card or medical||
0383|121|P|ID bracelet that identifies your use of this medication.||
0383|122|P|   Before having surgery, tell your doctor or dentist about all||
0383|123|P|the products you use (including prescription drugs,||
0383|124|P|nonprescription drugs, and herbal products).||
0383|125|P|   This medication may mask signs of infection. It can make you||
0383|126|P|more likely to get infections or may make current infections||
0383|127|P|worse. Stay away from anyone who has an infection that may easily||
0383|128|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0383|129|P|doctor if you have been exposed to an infection or for more||
0383|130|P|details.||
0383|131|P|   This medication may contain sugar and/or alcohol. Caution is||
0383|132|P|advised if you have diabetes, liver disease, or any other||
0383|133|P|condition that requires you to limit/avoid these substances in||
0383|134|P|your diet. Ask your doctor or pharmacist about using this product||
0383|135|P|safely.||
0383|136|P|   Tell your health care professional that you are using||
0383|137|P|prednisone before having any immunizations/vaccinations. Avoid||
0383|138|P|contact with people who have recently received live vaccines||
0383|139|P|(such as flu vaccine inhaled through the nose).||
0383|140|P|   This medication may cause stomach bleeding. Daily use of||
0383|141|P|alcohol while using this medication may increase your risk for||
0383|142|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
0383|143|P|or pharmacist for more information.||
0383|144|P|   Older adults may be more sensitive to the side effects of this||
0383|145|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
0383|146|P|mental/mood changes (such as confusion).||
0383|147|P|   This medication may slow down a child's growth if used for a||
0383|148|P|long time. Consult the doctor or pharmacist for more details. See||
0383|149|P|the doctor regularly so your child's height and growth can be||
0383|150|P|checked.||
0383|151|P|   During pregnancy, this medication should be used only when||
0383|152|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
0383|153|P|risks and benefits with your doctor. Infants born to mothers who||
0383|154|P|have been using this medication for an extended period of time||
0383|155|P|may have hormone problems. Tell your doctor right away if you||
0383|156|P|notice symptoms such as nausea/vomiting that doesn't stop, severe||
0383|157|P|diarrhea, or weakness in your newborn.||
0383|158|P|   This medication passes into breast milk but is unlikely to||
0383|159|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0383|160|B|||
0383|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0383|162|I|medications work or increase your risk for serious side effects.||
0383|163|I|This document does not contain all possible drug interactions.||
0383|164|I|Keep a list of all the products you use (including||
0383|165|I|prescription/nonprescription drugs and herbal products) and share||
0383|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
0383|167|I|the dosage of any medicines without your doctor's approval.||
0383|168|I|   Some products that may interact with this drug include:||
0383|169|I|aldesleukin, desmopressin, mifepristone, drugs that can cause||
0383|170|I|bleeding/bruising (including antiplatelet drugs such as||
0383|171|I|clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs||
0383|172|I|such as aspirin/celecoxib/ibuprofen).||
0383|173|I|   If your doctor has told you to take low-dose aspirin to||
0383|174|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0383|175|I|you should keep taking the aspirin unless your doctor tells you||
0383|176|I|not to. Ask your doctor or pharmacist for more details.||
0383|177|I|   This medication may interfere with certain lab tests (such as||
0383|178|I|skin tests), possibly causing false test results. Make sure lab||
0383|179|I|personnel and all your doctors know you use this drug.||
0383|180|B|||
0383|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0383|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0383|183|O|poison control center right away. US residents can call||
0383|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0383|185|B|||
0383|186|N|NOTES:  Do not share this medication with others.||
0383|187|N|   If this medication is used for a long time, lab and/or medical||
0383|188|N|tests (such as blood mineral levels, blood glucose, complete||
0383|189|N|blood count, height/weight measurements, bone density tests,||
0383|190|N|blood pressure, eye exams) should be done while you are taking||
0383|191|N|this medication. Keep all medical and lab appointments. Consult||
0383|192|N|your doctor for more details||
0383|193|N|   This medication may cause bone loss (osteoporosis) when used||
0383|194|N|for a long time. Lifestyle changes that may help reduce the risk||
0383|195|N|of bone problems include doing weight-bearing exercise, stopping||
0383|196|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
0383|197|N|D. Talk to your doctor for more details.||
0383|198|B|||
0383|199|D|MISSED DOSE:  If you are taking this medication daily and miss a||
0383|200|D|dose, take it as soon as you remember. If it is near the time of||
0383|201|D|the next dose, skip the missed dose. Take your next dose at the||
0383|202|D|regular time. Do not double the dose to catch up.||
0383|203|D|   If you are taking this medication on a different schedule than||
0383|204|D|a daily one (such as every other day), ask your doctor ahead of||
0383|205|D|time about what you should do if you miss a dose.||
0383|206|B|||
0383|207|R|STORAGE:  Store at room temperature. Once the bottle is opened,||
0383|208|R|this medication expires after 90 days. Keep all medications away||
0383|209|R|from children and pets.||
0383|210|R|   Do not flush medications down the toilet or pour them into a||
0383|211|R|drain unless instructed to do so. Properly discard this product||
0383|212|R|when it is expired or no longer needed. Consult your pharmacist||
0383|213|R|or local waste disposal company.||
0383|214|B|||
0383|215|M|MEDICAL ALERT:  Your condition can cause complications in a||
0383|216|M|medical emergency. For information about enrolling in MedicAlert,||
0383|217|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0383|218|B|||
0383|219|A|Information last revised September 2025.||
0383|220|A|Copyright(c) 2025 First Databank, Inc.||
0383|221|B|||
0384|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0384|002|Z|does NOT have all possible information about this product. This||
0384|003|Z|information does not assure that this product is safe, effective,||
0384|004|Z|or appropriate for you. This information is not individual||
0384|005|Z|medical advice and does not substitute for the advice of your||
0384|006|Z|health care professional. Always ask your health care||
0384|007|Z|professional for complete information about this product and your||
0384|008|Z|specific health needs.||
0384|009|B|||
0384|010|T|CEFADROXIL - ORAL||
0384|011|F|(SEF-a-DROX-il)||
0384|012|B|||
0384|013|C|COMMON BRAND NAME(S): Duricef||
0384|014|B|||
0384|015|U|USES:  This medication is used to treat a wide variety of||
0384|016|U|bacterial infections. It belongs to a class of drugs known as||
0384|017|U|cephalosporin antibiotics. It works by stopping the growth of||
0384|018|U|bacteria.||
0384|019|U|   This antibiotic treats only bacterial infections. It will not||
0384|020|U|work for viral infections (such as common cold, flu). Using any||
0384|021|U|antibiotic when it is not needed can cause it to not work for||
0384|022|U|future infections.||
0384|023|B|||
0384|024|V|OTHER USES:  This section contains uses of this drug that are not||
0384|025|V|listed in the approved professional labeling for the drug but||
0384|026|V|that may be prescribed by your health care professional. Use this||
0384|027|V|drug for a condition that is listed in this section only if it||
0384|028|V|has been so prescribed by your health care professional.||
0384|029|V|   This drug may also be used before dental procedures by people||
0384|030|V|with certain heart conditions (such as artificial heart valves)||
0384|031|V|to reduce the risk of a serious infection of the heart (bacterial||
0384|032|V|endocarditis).||
0384|033|B|||
0384|034|H|HOW TO USE:  Take this medication by mouth with or without food||
0384|035|H|as directed by your doctor, usually once or twice a day. You may||
0384|036|H|take this medication with food if stomach upset occurs.||
0384|037|H|   If you are using the liquid form of this medication, shake the||
0384|038|H|bottle well before each dose. Carefully measure the dose using a||
0384|039|H|special measuring device/spoon. Do not use a household spoon||
0384|040|H|because you may not get the correct dose.||
0384|041|H|   The dosage is based on your medical condition and response to||
0384|042|H|treatment. Children's dosage is also based on weight.||
0384|043|H|   For the best effect, take this antibiotic at evenly spaced||
0384|044|H|times. To help you remember, take this medication at the same||
0384|045|H|time(s) every day.||
0384|046|H|   Continue to take this medication until the full prescribed||
0384|047|H|amount is finished, even if symptoms disappear after a few days.||
0384|048|H|Stopping the medication too early may result in a return of the||
0384|049|H|infection.||
0384|050|H|   Tell your doctor if your condition lasts or gets worse.||
0384|051|B|||
0384|052|S|SIDE EFFECTS:  Stomach upset, nausea, vomiting, or diarrhea may||
0384|053|S|occur. If any of these effects last or get worse, tell your||
0384|054|S|doctor or pharmacist promptly.||
0384|055|S|   Remember that this medication has been prescribed because your||
0384|056|S|doctor has judged that the benefit to you is greater than the||
0384|057|S|risk of side effects. Many people using this medication do not||
0384|058|S|have serious side effects.||
0384|059|S|   Tell your doctor right away if you have any serious side||
0384|060|S|effects, including: signs of liver disease (such as||
0384|061|S|nausea/vomiting that doesn't stop, loss of appetite,||
0384|062|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), new||
0384|063|S|signs of infection (such as sore throat that doesn't go away,||
0384|064|S|fever, chills), easy bruising/bleeding, signs of kidney problems||
0384|065|S|(such as change in the amount of urine), mental/mood changes||
0384|066|S|(such as confusion).||
0384|067|S|   This medication may rarely cause a severe intestinal condition||
0384|068|S|due to a bacteria called C. difficile. This condition may occur||
0384|069|S|during treatment or weeks to months after treatment has stopped.||
0384|070|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0384|071|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0384|072|S|stool.||
0384|073|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0384|074|S|products because they may make symptoms worse.||
0384|075|S|   Use of this medication for prolonged or repeated periods may||
0384|076|S|result in oral thrush or a new yeast infection. Contact your||
0384|077|S|doctor if you notice white patches in your mouth, a change in||
0384|078|S|vaginal discharge or other new symptoms.||
0384|079|S|   A very serious allergic reaction to this drug is rare.||
0384|080|S|However, get medical help right away if you notice any symptoms||
0384|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0384|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0384|083|S|breathing.||
0384|084|S|   This is not a complete list of possible side effects. If you||
0384|085|S|notice other effects not listed above, contact your doctor or||
0384|086|S|pharmacist.||
0384|087|S|   In the US -||
0384|088|S|   Call your doctor for medical advice about side effects. You||
0384|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0384|090|S|www.fda.gov/medwatch.||
0384|091|S|   In Canada - Call your doctor for medical advice about side||
0384|092|S|effects. You may report side effects to Health Canada at||
0384|093|S|1-866-234-2345.||
0384|094|B|||
0384|095|P|PRECAUTIONS:  Before taking cefadroxil, tell your doctor or||
0384|096|P|pharmacist if you are allergic to it; or to penicillins or other||
0384|097|P|cephalosporins; or if you have any other allergies. This product||
0384|098|P|may contain inactive ingredients, which can cause allergic||
0384|099|P|reactions or other problems. Talk to your pharmacist for more||
0384|100|P|details.||
0384|101|P|   Before using this medication, tell your doctor or pharmacist||
0384|102|P|your medical history, especially of: kidney disease, intestinal||
0384|103|P|disease (colitis).||
0384|104|P|   Cefadroxil may cause live bacterial vaccines (such as typhoid||
0384|105|P|vaccine) to not work well. Tell your health care professional||
0384|106|P|that you are using cefadroxil before having any||
0384|107|P|immunizations/vaccinations.||
0384|108|P|   The suspension may contain sugar. Caution is advised if you||
0384|109|P|have diabetes or any other condition that requires you to||
0384|110|P|limit/avoid sugar in your diet. Ask your doctor or pharmacist||
0384|111|P|about using this product safely.||
0384|112|P|   Before having surgery, tell your doctor or dentist about all||
0384|113|P|the products you use (including prescription drugs,||
0384|114|P|nonprescription drugs, and herbal products).||
0384|115|P|   During pregnancy, this medication should be used only when||
0384|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
0384|117|P|   This medication passes into breast milk, but is unlikely to||
0384|118|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0384|119|B|||
0384|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0384|121|I|medications work or increase your risk for serious side effects.||
0384|122|I|This document does not contain all possible drug interactions.||
0384|123|I|Keep a list of all the products you use (including||
0384|124|I|prescription/nonprescription drugs and herbal products) and share||
0384|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
0384|126|I|the dosage of any medicines without your doctor's approval.||
0384|127|I|   This medication may cause false positive results with certain||
0384|128|I|diabetic urine testing products (cupric sulfate-type). This drug||
0384|129|I|may also affect the results of certain lab tests. Make sure lab||
0384|130|I|personnel and all your doctors know you use this drug.||
0384|131|B|||
0384|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0384|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0384|134|O|poison control center right away. US residents can call||
0384|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0384|136|O|Symptoms of overdose may include: seizures.||
0384|137|B|||
0384|138|N|NOTES:  Do not share this medication with others.||
0384|139|N|   This medication has been prescribed for your current condition||
0384|140|N|only. Do not use it later for another infection unless your||
0384|141|N|doctor tells you to.||
0384|142|N|   Lab and/or medical tests (such as kidney function) may be done||
0384|143|N|while you are taking this medication. Keep all medical and lab||
0384|144|N|appointments. Consult your doctor for more details.||
0384|145|B|||
0384|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0384|147|D|If it is near the time of the next dose, skip the missed dose.||
0384|148|D|Use your next dose at the regular time. Do not double the dose to||
0384|149|D|catch up.||
0384|150|B|||
0384|151|R|STORAGE:  Store the capsules/tablets at room temperature away||
0384|152|R|from light and moisture. Do not store in the bathroom. Store the||
0384|153|R|suspension in the refrigerator and discard any unused portion||
0384|154|R|after 14 days. Do not freeze. Keep all medications away from||
0384|155|R|children and pets.||
0384|156|R|   Do not flush medications down the toilet or pour them into a||
0384|157|R|drain unless instructed to do so. Properly discard this product||
0384|158|R|when it is expired or no longer needed. Consult your pharmacist||
0384|159|R|or local waste disposal company.||
0384|160|B|||
0384|161|A|Information last revised April 2025.||
0384|162|A|Copyright(c) 2025 First Databank, Inc.||
0384|163|B|||
0385|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0385|002|Z|does NOT have all possible information about this product. This||
0385|003|Z|information does not assure that this product is safe, effective,||
0385|004|Z|or appropriate for you. This information is not individual||
0385|005|Z|medical advice and does not substitute for the advice of your||
0385|006|Z|health care professional. Always ask your health care||
0385|007|Z|professional for complete information about this product and your||
0385|008|Z|specific health needs.||
0385|009|B|||
0385|010|T|CEFACLOR - ORAL||
0385|011|F|(SEF-a-klor)||
0385|012|B|||
0385|013|C|COMMON BRAND NAME(S): Ceclor||
0385|014|B|||
0385|015|U|USES:  This medication is a cephalosporin-type antibiotic used to||
0385|016|U|treat a wide variety of bacterial infections (such as middle ear,||
0385|017|U|skin, urine and respiratory tract infections). It works by||
0385|018|U|stopping the growth of bacteria.||
0385|019|U|   This antibiotic only treats bacterial infections. It will not||
0385|020|U|work for viral infections (such as common cold, flu). Unnecessary||
0385|021|U|use or overuse of any antibiotic can lead to its decreased||
0385|022|U|effectiveness.||
0385|023|B|||
0385|024|H|HOW TO USE:  Take this medication by mouth with or without food||
0385|025|H|as directed by your doctor, usually every 8 or 12 hours. You may||
0385|026|H|take this medicine with food if stomach upset occurs.||
0385|027|H|   For the best effect, take this antibiotic at evenly spaced||
0385|028|H|times. To help you remember, take this medication at the same||
0385|029|H|time(s) every day.||
0385|030|H|   Continue to take this medication until the full prescribed||
0385|031|H|amount is finished, even if symptoms disappear after a few days.||
0385|032|H|Stopping the medication too early may result in a return of the||
0385|033|H|infection.||
0385|034|H|   Tell your doctor if your condition lasts or gets worse.||
0385|035|B|||
0385|036|S|SIDE EFFECTS:  Stomach upset, headache, nausea, vomiting, or||
0385|037|S|diarrhea may occur. If any of these effects last or get worse,||
0385|038|S|notify your doctor or pharmacist promptly.||
0385|039|S|   Remember that this medication has been prescribed because your||
0385|040|S|doctor has judged that the benefit to you is greater than the||
0385|041|S|risk of side effects. Many people using this medication do not||
0385|042|S|have serious side effects.||
0385|043|S|   Tell your doctor right away if you have any serious side||
0385|044|S|effects, including: signs of liver problems (such as||
0385|045|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
0385|046|S|yellowing eyes/skin, dark urine), unusual joint pain, new signs||
0385|047|S|of infection (such as sore throat that doesn't go away, fever,||
0385|048|S|chills), easy bruising/bleeding, signs of kidney problems (such||
0385|049|S|as change in the amount of urine), mental/mood changes (such||
0385|050|S|confusion).||
0385|051|S|   This medication may rarely cause a severe intestinal condition||
0385|052|S|due to a bacteria called C. difficile. This condition may occur||
0385|053|S|during treatment or weeks to months after treatment has stopped.||
0385|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0385|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0385|056|S|stool.||
0385|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0385|058|S|products because they may make symptoms worse.||
0385|059|S|   Use of this medication for prolonged or repeated periods may||
0385|060|S|result in oral thrush or a new vaginal yeast infection (oral or||
0385|061|S|vaginal fungal infection). Contact your doctor if you notice||
0385|062|S|white patches in your mouth, a change in vaginal discharge or||
0385|063|S|other new symptoms.||
0385|064|S|   A very serious allergic reaction to this drug is rare.||
0385|065|S|However, get medical help right away if you notice any symptoms||
0385|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0385|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0385|068|S|breathing.||
0385|069|S|   This is not a complete list of possible side effects. If you||
0385|070|S|notice other effects not listed above, contact your doctor or||
0385|071|S|pharmacist.||
0385|072|S|   In the US -||
0385|073|S|   Call your doctor for medical advice about side effects. You||
0385|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0385|075|S|www.fda.gov/medwatch.||
0385|076|S|   In Canada - Call your doctor for medical advice about side||
0385|077|S|effects. You may report side effects to Health Canada at||
0385|078|S|1-866-234-2345.||
0385|079|B|||
0385|080|P|PRECAUTIONS:  Before taking cefaclor, tell your doctor or||
0385|081|P|pharmacist if you are allergic to it; or to penicillins or other||
0385|082|P|cephalosporins; or if you have any other allergies. This product||
0385|083|P|may contain inactive ingredients, which can cause allergic||
0385|084|P|reactions or other problems. Talk to your pharmacist for more||
0385|085|P|details.||
0385|086|P|   Before using this medication, tell your doctor or pharmacist||
0385|087|P|your medical history, especially of: kidney disease, intestinal||
0385|088|P|disease (colitis).||
0385|089|P|   Cefaclor may cause live bacterial vaccines (such as typhoid||
0385|090|P|vaccine) to not work well. Tell your health care professional||
0385|091|P|that you are using cefaclor before having any||
0385|092|P|immunizations/vaccinations.||
0385|093|P|   Before having surgery, tell your doctor or dentist about all||
0385|094|P|the products you use (including prescription drugs,||
0385|095|P|nonprescription drugs, and herbal products).||
0385|096|P|   During pregnancy, this medication should be used only when||
0385|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
0385|098|P|   This medication passes into breast milk. Consult your doctor||
0385|099|P|before breastfeeding.||
0385|100|B|||
0385|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0385|102|I|medications work or increase your risk for serious side effects.||
0385|103|I|This document does not contain all possible drug interactions.||
0385|104|I|Keep a list of all the products you use (including||
0385|105|I|prescription/nonprescription drugs and herbal products) and share||
0385|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
0385|107|I|the dosage of any medicines without your doctor's approval.||
0385|108|I|   This medication may interfere with certain lab tests (such as||
0385|109|I|certain diabetic urine tests), possibly causing false test||
0385|110|I|results. Make sure lab personnel and all your doctors know you||
0385|111|I|use this drug.||
0385|112|B|||
0385|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0385|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0385|115|O|poison control center right away. US residents can call||
0385|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0385|117|O|Symptoms of overdose may include severe vomiting, seizures.||
0385|118|B|||
0385|119|N|NOTES:  Do not share this medication with others.||
0385|120|N|   This medication has been prescribed for your current condition||
0385|121|N|only. Do not use it later for another infection unless your||
0385|122|N|doctor tells you to.||
0385|123|B|||
0385|124|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0385|125|D|If it is near the time of the next dose, skip the missed dose.||
0385|126|D|Use your next dose at the regular time. Do not double the dose to||
0385|127|D|catch up.||
0385|128|B|||
0385|129|R|STORAGE:  Store at room temperature away from light and moisture.||
0385|130|R|Do not store in the bathroom. Keep all medications away from||
0385|131|R|children and pets.||
0385|132|R|   Do not flush medications down the toilet or pour them into a||
0385|133|R|drain unless instructed to do so. Properly discard this product||
0385|134|R|when it is expired or no longer needed. Consult your pharmacist||
0385|135|R|or local waste disposal company.||
0385|136|B|||
0385|137|A|Information last revised May 2025.||
0385|138|A|Copyright(c) 2025 First Databank, Inc.||
0385|139|B|||
0388|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0388|002|Z|does NOT have all possible information about this product. This||
0388|003|Z|information does not assure that this product is safe, effective,||
0388|004|Z|or appropriate for you. This information is not individual||
0388|005|Z|medical advice and does not substitute for the advice of your||
0388|006|Z|health care professional. Always ask your health care||
0388|007|Z|professional for complete information about this product and your||
0388|008|Z|specific health needs.||
0388|009|B|||
0388|010|T|OLANZAPINE - INTRAMUSCULAR||
0388|011|F|(oh-LAN-za-peen)||
0388|012|B|||
0388|013|C|COMMON BRAND NAME(S): Zyprexa||
0388|014|B|||
0388|015|W|WARNING:  There may be a slightly increased risk of serious,||
0388|016|W|possibly fatal side effects (such as stroke, heart failure,||
0388|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
0388|018|W|by older adults with dementia. This medication is not approved||
0388|019|W|for the treatment of dementia-related behavior problems. Discuss||
0388|020|W|the risks and benefits of this medication, as well as other||
0388|021|W|effective and possibly safer treatments for dementia-related||
0388|022|W|behavior problems, with the doctor.||
0388|023|B|||
0388|024|U|USES:  This medication is used to treat severe agitation||
0388|025|U|associated with certain mental/mood conditions (schizophrenia,||
0388|026|U|bipolar mania). Olanzapine belongs to a class of drugs known as||
0388|027|U|atypical antipsychotics. It works by helping to restore the||
0388|028|U|balance of certain natural substances in the brain.||
0388|029|U|   Talk to the doctor about the risks and benefits of treatment||
0388|030|U|(especially when used in teenagers). See also Precautions||
0388|031|U|section.||
0388|032|B|||
0388|033|H|HOW TO USE:  Read the Medication Guide provided by your||
0388|034|H|pharmacist before you start using olanzapine and each time you||
0388|035|H|get an injection. If you have any questions, ask your doctor or||
0388|036|H|pharmacist.||
0388|037|H|   This medication is given by a slow injection into a muscle by||
0388|038|H|a healthcare professional. The dosage is based on your medical||
0388|039|H|condition and response to treatment.||
0388|040|H|   This medication is intended for short-term control of acute||
0388|041|H|agitation symptoms. If you require continuous treatment for your||
0388|042|H|condition, your doctor may switch you to an oral medication.||
0388|043|B|||
0388|044|S|SIDE EFFECTS:  Dry mouth, constipation, nausea, dizziness,||
0388|045|S|lightheadedness, stomach pain, weight gain, drowsiness, back||
0388|046|S|pain, or redness/pain/swelling at the injection site may occur.||
0388|047|S|If any of these effects last or get worse, notify your doctor or||
0388|048|S|pharmacist promptly.||
0388|049|S|   Dizziness and lightheadedness can increase the risk of||
0388|050|S|falling. Get up slowly when rising from a sitting or lying||
0388|051|S|position.||
0388|052|S|   Remember that this medication has been prescribed because your||
0388|053|S|doctor has judged that the benefit to you is greater than the||
0388|054|S|risk of side effects. Many people using this medication do not||
0388|055|S|have serious side effects.||
0388|056|S|   Tell your doctor right away if you have any serious side||
0388|057|S|effects, including: mental/mood changes (such as confusion,||
0388|058|S|agitation, restlessness), slow heartbeat, weakness,||
0388|059|S|numbness/tingling of hands/feet, tremor, yellowing eyes/skin,||
0388|060|S|severe stomach/abdominal pain, difficulty swallowing, trouble||
0388|061|S|urinating, interrupted breathing during sleep.||
0388|062|S|   Get medical help right away if you have any very serious side||
0388|063|S|effects, including: seizures.||
0388|064|S|   This drug may rarely make your blood sugar rise, which can||
0388|065|S|cause or worsen diabetes. Tell your doctor right away if you have||
0388|066|S|symptoms of high blood sugar such as increased thirst/urination.||
0388|067|S|If you already have diabetes, check your blood sugar regularly as||
0388|068|S|directed and share the results with your doctor. Your doctor may||
0388|069|S|need to adjust your diabetes medication, exercise program, or||
0388|070|S|diet.||
0388|071|S|   This drug may also cause significant weight gain and a rise in||
0388|072|S|your blood cholesterol (or triglyceride) levels, especially in||
0388|073|S|teenagers. These effects, along with diabetes, may increase your||
0388|074|S|risk for developing heart disease. Discuss the risks and benefits||
0388|075|S|of treatment with your doctor. (See also Notes section.)||
0388|076|S|   This medication may rarely cause a very serious condition||
0388|077|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0388|078|S|right away if you have any of the following symptoms: fever,||
0388|079|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
0388|080|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
0388|081|S|signs of kidney problems (such as change in the amount of urine).||
0388|082|S|   Olanzapine may rarely cause a condition known as tardive||
0388|083|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0388|084|S|your doctor right away if you develop any unusual/uncontrolled||
0388|085|S|movements (especially of the face or tongue).||
0388|086|S|   In rare instances, this medication may increase your blood||
0388|087|S|level of a certain hormone (prolactin). For females, this rare||
0388|088|S|increase in prolactin levels may result in unwanted breast milk,||
0388|089|S|the menstrual period stopping, or difficulty becoming pregnant.||
0388|090|S|For males, it may result in decreased sexual ability, inability||
0388|091|S|to produce sperm, or enlarged breasts. If you develop any of||
0388|092|S|these symptoms, tell your doctor right away.||
0388|093|S|   A very serious allergic reaction to this drug is rare.||
0388|094|S|However, get medical help right away if you notice any symptoms||
0388|095|S|of a serious allergic reaction, including: fever, swollen lymph||
0388|096|S|nodes, rash, itching/swelling (especially of the||
0388|097|S|face/tongue/throat), severe dizziness, trouble breathing.||
0388|098|S|   This is not a complete list of possible side effects. If you||
0388|099|S|notice other effects not listed above, contact your doctor or||
0388|100|S|pharmacist.||
0388|101|S|   In the US -||
0388|102|S|   Call your doctor for medical advice about side effects. You||
0388|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0388|104|S|www.fda.gov/medwatch.||
0388|105|S|   In Canada - Call your doctor for medical advice about side||
0388|106|S|effects. You may report side effects to Health Canada at||
0388|107|S|1-866-234-2345.||
0388|108|B|||
0388|109|P|PRECAUTIONS:  Before using olanzapine, tell your doctor or||
0388|110|P|pharmacist if you are allergic to it; or if you have any other||
0388|111|P|allergies. This product may contain inactive ingredients, which||
0388|112|P|can cause allergic reactions or other problems. Talk to your||
0388|113|P|pharmacist for more details.||
0388|114|P|   Before using this medication, tell your doctor or pharmacist||
0388|115|P|your medical history, especially of: liver problems, dementia,||
0388|116|P|seizures, difficulty urinating (for example, due to enlarged||
0388|117|P|prostate), glaucoma (narrow angle), stomach/intestinal problems||
0388|118|P|(such as blockage, chronic constipation, paralytic ileus),||
0388|119|P|difficulty swallowing, smoking, low white blood cell count,||
0388|120|P|personal or family history of diabetes, heart disease, high||
0388|121|P|cholesterol/triglyceride levels, breathing trouble during sleep||
0388|122|P|(sleep apnea).||
0388|123|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0388|124|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0388|125|P|machinery, or do anything that needs alertness until you can do||
0388|126|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0388|127|P|are using marijuana (cannabis).||
0388|128|P|   This medication may make you sweat less, making you more||
0388|129|P|likely to get heat stroke. Avoid doing things that may cause you||
0388|130|P|to overheat, such as hard work or exercise in hot weather, or||
0388|131|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0388|132|P|and dress lightly. If you overheat, quickly look for a place to||
0388|133|P|cool down and rest. Get medical help right away if you have a||
0388|134|P|fever that does not go away, mental/mood changes, headache, or||
0388|135|P|dizziness.||
0388|136|P|   Teenagers may be more sensitive to the side effects of this||
0388|137|P|drug, especially weight gain, and also increased amounts of||
0388|138|P|cholesterol, triglycerides and prolactin. See also Side Effects||
0388|139|P|section for more details.||
0388|140|P|   Older adults may be more sensitive to the side effects of this||
0388|141|P|drug, especially drowsiness, constipation, trouble urinating,||
0388|142|P|confusion, dizziness, and lightheadedness. Drowsiness, confusion,||
0388|143|P|dizziness, and lightheadedness can increase the risk of falling.||
0388|144|P|   During pregnancy, this medication should be used only when||
0388|145|P|clearly needed. Babies born to mothers who have used this drug||
0388|146|P|during the last 3 months of pregnancy may rarely develop symptoms||
0388|147|P|including muscle stiffness or shakiness, drowsiness,||
0388|148|P|feeding/breathing difficulties, or constant crying. If you notice||
0388|149|P|any of these symptoms in your newborn especially during their||
0388|150|P|first month, tell the doctor right away.||
0388|151|P|   Since untreated mental/mood problems (such as schizophrenia,||
0388|152|P|bipolar mania) can be a serious condition, do not stop taking||
0388|153|P|this medication unless directed by your doctor. If you are||
0388|154|P|planning pregnancy, become pregnant, or think you may be||
0388|155|P|pregnant, immediately discuss with your doctor the benefits and||
0388|156|P|risks of using this medication during pregnancy.||
0388|157|P|   This drug passes into breast milk and may have undesirable||
0388|158|P|effects on a nursing infant. Tell the doctor right away if your||
0388|159|P|baby develops symptoms such as muscle stiffness or shakiness,||
0388|160|P|unusual sleepiness, or difficulty feeding. Consult your doctor||
0388|161|P|before breastfeeding.||
0388|162|B|||
0388|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0388|164|I|medications work or increase your risk for serious side effects.||
0388|165|I|This document does not contain all possible drug interactions.||
0388|166|I|Keep a list of all the products you use (including||
0388|167|I|prescription/nonprescription drugs and herbal products) and share||
0388|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
0388|169|I|the dosage of any medicines without your doctor's approval.||
0388|170|I|   A product that may interact with this drug is: metoclopramide.||
0388|171|I|   Tell your doctor or pharmacist if you are taking other||
0388|172|I|products that cause drowsiness such as opioid pain or cough||
0388|173|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0388|174|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0388|175|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0388|176|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0388|177|I|diphenhydramine).||
0388|178|I|   Check the labels on all your medicines (such as allergy or||
0388|179|I|cough-and-cold products) because they may contain ingredients||
0388|180|I|that cause drowsiness. Ask your pharmacist about using those||
0388|181|I|products safely.||
0388|182|B|||
0388|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0388|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0388|185|O|poison control center right away. US residents can call||
0388|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0388|187|O|Symptoms of overdose may include: severe drowsiness, trouble||
0388|188|O|speaking, slowed breathing, or seizures.||
0388|189|B|||
0388|190|N|NOTES:  Lab and/or medical tests (such as fasting blood sugar,||
0388|191|N|weight, blood pressure, blood cholesterol/triglyceride levels,||
0388|192|N|liver function) should be done while you are using this||
0388|193|N|medication. Keep all medical and lab appointments. Consult your||
0388|194|N|doctor for more details||
0388|195|B|||
0388|196|D|MISSED DOSE:  Not applicable.||
0388|197|B|||
0388|198|R|STORAGE:  Not applicable. This medication is given in a hospital||
0388|199|R|and will not be stored at home.||
0388|200|B|||
0388|201|A|Information last revised May 2025.||
0388|202|A|Copyright(c) 2025 First Databank, Inc.||
0388|203|B|||
0390|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0390|002|Z|does NOT have all possible information about this product. This||
0390|003|Z|information does not assure that this product is safe, effective,||
0390|004|Z|or appropriate for you. This information is not individual||
0390|005|Z|medical advice and does not substitute for the advice of your||
0390|006|Z|health care professional. Always ask your health care||
0390|007|Z|professional for complete information about this product and your||
0390|008|Z|specific health needs.||
0390|009|B|||
0390|010|T|CARBIDOPA/LEVODOPA/ENTACAPONE - ORAL||
0390|011|F|(KAR-bi-DOE-pa/LEE-vo-DOE-pa/en-TAK-a-pone)||
0390|012|B|||
0390|013|C|COMMON BRAND NAME(S): Stalevo||
0390|014|B|||
0390|015|U|USES:  This combination medication is used to treat symptoms of||
0390|016|U|Parkinson's disease (such as shakiness, stiffness, difficulty||
0390|017|U|moving). Parkinson's disease is thought to be caused by too||
0390|018|U|little of a naturally occurring substance (dopamine) in the||
0390|019|U|brain. Levodopa changes into dopamine in the brain, helping to||
0390|020|U|control movement. Carbidopa and entacapone prevent the breakdown||
0390|021|U|of levodopa in the bloodstream so more levodopa can enter the||
0390|022|U|brain. Carbidopa can also reduce some of levodopa's side effects||
0390|023|U|such as nausea and vomiting.||
0390|024|B|||
0390|025|H|HOW TO USE:  Take this medication by mouth with or without food||
0390|026|H|as directed by your doctor, usually 3 to 4 times a day. Take only||
0390|027|H|one tablet for each dose. Swallow the tablet whole. Do not crush,||
0390|028|H|chew, or split the tablet. Doing so may cause you to get the||
0390|029|H|wrong dose and may also cause staining of the mouth, dentures,||
0390|030|H|and saliva. See also Side Effects section.||
0390|031|H|   Taking this medication with food may help to decrease nausea.||
0390|032|H|It is best to avoid a high-protein diet (it decreases the amount||
0390|033|H|of levodopa that your body takes in) during treatment, unless||
0390|034|H|directed otherwise by your doctor. Also avoid taking this||
0390|035|H|medication with a high-fat, high-calorie meal since this can slow||
0390|036|H|down the time it begins to work by about 2 hours.||
0390|037|H|   Separate your dose of this medication by as many hours as||
0390|038|H|possible from any iron supplements or products containing iron||
0390|039|H|(such as multivitamins with minerals) you may take. Iron can||
0390|040|H|reduce the amount of this medication absorbed by the body.||
0390|041|H|Consult your doctor or pharmacist for more details.||
0390|042|H|   The dosage is based on your medical condition and response to||
0390|043|H|treatment. Use this medication regularly to get the most benefit||
0390|044|H|from it. To help you remember, take it at the same times each||
0390|045|H|day.||
0390|046|H|   Some patients may experience a "wearing-off" (worsening of||
0390|047|H|symptoms) before the next dose is due. An "on-off" effect might||
0390|048|H|also occur, in which sudden short periods of stiffness occur. If||
0390|049|H|these effects occur, contact your doctor for possible dose||
0390|050|H|adjustments that may help to lessen this effect.||
0390|051|H|   Do not stop taking this medication without consulting your||
0390|052|H|doctor. Some conditions may become worse when this medication is||
0390|053|H|suddenly stopped. Also, if you suddenly stop using this||
0390|054|H|medication, you may have withdrawal symptoms (such as anxiety,||
0390|055|H|depression, confusion, fever, muscle stiffness). To help prevent||
0390|056|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0390|057|H|more likely if you have used this medication for a long time or||
0390|058|H|in high doses. Tell your doctor or pharmacist right away if you||
0390|059|H|have withdrawal.||
0390|060|H|   Tell your doctor if your condition does not get better or if||
0390|061|H|it gets worse.||
0390|062|B|||
0390|063|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, dizziness,||
0390|064|S|lightheadedness, drowsiness, stomach upset, loss of appetite,||
0390|065|S|trouble sleeping, headache, or dry mouth may occur. If any of||
0390|066|S|these effects last or get worse, tell your doctor or pharmacist||
0390|067|S|promptly.||
0390|068|S|   This medication may cause saliva, urine, or sweat to turn a||
0390|069|S|dark color. This effect is harmless, but your clothes may be||
0390|070|S|stained.||
0390|071|S|   To reduce the risk of dizziness and lightheadedness, get up||
0390|072|S|slowly when rising from a sitting or lying position.||
0390|073|S|   Remember that this medication has been prescribed because your||
0390|074|S|doctor has judged that the benefit to you is greater than the||
0390|075|S|risk of side effects. Many people using this medication do not||
0390|076|S|have serious side effects.||
0390|077|S|   Some people taking this medication have fallen asleep suddenly||
0390|078|S|during their usual daily activities (such as talking on the||
0390|079|S|phone, driving). In some cases, sleep occurred without any||
0390|080|S|feelings of drowsiness beforehand. This sleep effect may occur||
0390|081|S|anytime during treatment with this medication even if you have||
0390|082|S|used this medication for a long time. If you experience increased||
0390|083|S|sleepiness or fall asleep during the day, do not drive or do||
0390|084|S|other possibly dangerous activities until you have discussed this||
0390|085|S|effect with your doctor. Your risk of this sleep effect is||
0390|086|S|increased by using alcohol or other medications that can make you||
0390|087|S|drowsy. See also Precautions section.||
0390|088|S|   Tell your doctor right away if you have any serious side||
0390|089|S|effects, including: new/worsening movements you can't||
0390|090|S|control/spasms, greatly increased eye blinking/twitching,||
0390|091|S|diarrhea that doesn't stop, vision changes (such as blurred||
0390|092|S|vision), eye pain, severe stomach/abdominal pain, black/tarry||
0390|093|S|stools, vomit that looks like coffee grounds, muscle||
0390|094|S|pain/tenderness/weakness, signs of kidney problems (such as||
0390|095|S|change in the amount of urine), mental/mood changes (such as||
0390|096|S|confusion, agitation, hallucinations), signs of infection (such||
0390|097|S|as sore throat that doesn't go away, fever, chills), easy||
0390|098|S|bleeding/bruising, unusual tiredness, tingling of the hands/feet,||
0390|099|S|unusual strong urges (such as increased gambling, increased||
0390|100|S|sexual urges).||
0390|101|S|   Get medical help right away if you have any very serious side||
0390|102|S|effects, including: chest pain, fainting.||
0390|103|S|   Suddenly stopping or reducing the dose of this medication may||
0390|104|S|rarely cause a very serious condition called neuroleptic||
0390|105|S|malignant syndrome (NMS). Get medical help right away if you have||
0390|106|S|any of the following symptoms: fever, unusual muscle stiffness,||
0390|107|S|severe confusion, sweating, fast/irregular heartbeat.||
0390|108|S|   A very serious allergic reaction to this drug is rare.||
0390|109|S|However, get medical help right away if you notice any symptoms||
0390|110|S|of a serious allergic reaction, including: rash, itching/swelling||
0390|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0390|112|S|breathing.||
0390|113|S|   This is not a complete list of possible side effects. If you||
0390|114|S|notice other effects not listed above, contact your doctor or||
0390|115|S|pharmacist.||
0390|116|S|   In the US -||
0390|117|S|   Call your doctor for medical advice about side effects. You||
0390|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0390|119|S|www.fda.gov/medwatch.||
0390|120|S|   In Canada - Call your doctor for medical advice about side||
0390|121|S|effects. You may report side effects to Health Canada at||
0390|122|S|1-866-234-2345.||
0390|123|B|||
0390|124|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0390|125|P|pharmacist if you are allergic to carbidopa, levodopa, or||
0390|126|P|entacapone; or to foscarbidopa or foslevodopa; or if you have any||
0390|127|P|other allergies. This product may contain inactive ingredients,||
0390|128|P|which can cause allergic reactions or other problems. Talk to||
0390|129|P|your pharmacist for more details.||
0390|130|P|   Before using this medication, tell your doctor or pharmacist||
0390|131|P|your medical history, especially of: liver disease, glaucoma,||
0390|132|P|breathing problems (such as asthma), heart disease (such as heart||
0390|133|P|attack, irregular heartbeat), kidney disease, stomach/intestinal||
0390|134|P|ulcer, mental/mood disorders (such as depression, schizophrenia),||
0390|135|P|blood disorders, seizures, sleep disorders.||
0390|136|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0390|137|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0390|138|P|machinery, or do anything that needs alertness until you can do||
0390|139|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0390|140|P|are using marijuana (cannabis). See also Side Effects section.||
0390|141|P|   Before having surgery, tell your doctor or dentist about all||
0390|142|P|the products you use (including prescription drugs,||
0390|143|P|nonprescription drugs, and herbal products).||
0390|144|P|   During pregnancy, this medication should be used only when||
0390|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
0390|146|P|   Levodopa passes into breast milk. It is unknown if carbidopa||
0390|147|P|or entacapone pass into breast milk. Consult your doctor before||
0390|148|P|breastfeeding.||
0390|149|B|||
0390|150|I|DRUG INTERACTIONS:  See also How to Use section.||
0390|151|I|   Drug interactions may change how your medications work or||
0390|152|I|increase your risk for serious side effects. This document does||
0390|153|I|not contain all possible drug interactions. Keep a list of all||
0390|154|I|the products you use (including prescription/nonprescription||
0390|155|I|drugs and herbal products) and share it with your doctor and||
0390|156|I|pharmacist. Do not start, stop, or change the dosage of any||
0390|157|I|medicines without your doctor's approval.||
0390|158|I|   Some products that may interact with this drug include:||
0390|159|I|certain drugs used to treat high blood pressure (such as||
0390|160|I|methyldopa).||
0390|161|I|   Taking MAO inhibitors with this medication may cause a serious||
0390|162|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0390|163|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0390|164|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
0390|165|I|treatment with this medication. Most MAO inhibitors should also||
0390|166|I|not be taken for two weeks before treatment with this medication.||
0390|167|I|However, certain MAO inhibitors (rasagiline, safinamide,||
0390|168|I|selegiline) may be used with careful monitoring by your doctor.||
0390|169|I|Ask your doctor when to start or stop taking this medication.||
0390|170|I|   Tell your doctor or pharmacist if you are taking other||
0390|171|I|products that cause drowsiness including alcohol, marijuana||
0390|172|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0390|173|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0390|174|I|zolpidem), muscle relaxants (such as carisoprodol,||
0390|175|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
0390|176|I|hydrocodone).||
0390|177|I|   Check the labels on all your medicines (such as allergy or||
0390|178|I|cough-and-cold products) because they may contain ingredients||
0390|179|I|that cause drowsiness. Ask your pharmacist about using those||
0390|180|I|products safely.||
0390|181|I|   This medication may interfere with certain lab tests (such as||
0390|182|I|urine catecholamine/glucose/ketone tests), possibly causing false||
0390|183|I|test results. Make sure lab personnel and all your doctors know||
0390|184|I|you use this drug.||
0390|185|B|||
0390|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0390|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0390|188|O|poison control center right away. US residents can call||
0390|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0390|190|O|Symptoms of overdose may include: severe dizziness,||
0390|191|O|fast/irregular heartbeat, mental/mood changes (such as||
0390|192|O|agitation).||
0390|193|B|||
0390|194|N|NOTES:  Do not share this medication with others.||
0390|195|N|   Lab and/or medical tests (such as complete blood count,||
0390|196|N|heart/kidney/liver function, blood pressure) should be done while||
0390|197|N|you are taking this medication. Keep all medical and lab||
0390|198|N|appointments. Consult your doctor for more details.||
0390|199|B|||
0390|200|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0390|201|D|If it is near the time of the next dose, skip the missed dose.||
0390|202|D|Use your next dose at the regular time. Do not double the dose to||
0390|203|D|catch up.||
0390|204|B|||
0390|205|R|STORAGE:  Store at room temperature away from light and moisture.||
0390|206|R|Do not store in the bathroom. Keep all medications away from||
0390|207|R|children and pets.||
0390|208|R|   Do not flush medications down the toilet or pour them into a||
0390|209|R|drain unless instructed to do so. Properly discard this product||
0390|210|R|when it is expired or no longer needed. Consult your pharmacist||
0390|211|R|or local waste disposal company.||
0390|212|B|||
0390|213|A|Information last revised April 2025.||
0390|214|A|Copyright(c) 2025 First Databank, Inc.||
0390|215|B|||
0393|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0393|002|Z|does NOT have all possible information about this product. This||
0393|003|Z|information does not assure that this product is safe, effective,||
0393|004|Z|or appropriate for you. This information is not individual||
0393|005|Z|medical advice and does not substitute for the advice of your||
0393|006|Z|health care professional. Always ask your health care||
0393|007|Z|professional for complete information about this product and your||
0393|008|Z|specific health needs.||
0393|009|B|||
0393|010|T|TOLTERODINE EXTENDED-RELEASE - ORAL||
0393|011|F|(tol-TER-oh-deen)||
0393|012|B|||
0393|013|C|COMMON BRAND NAME(S): Detrol LA||
0393|014|B|||
0393|015|U|USES:  This medication is used to treat an overactive bladder. By||
0393|016|U|relaxing the muscles in the bladder, tolterodine improves your||
0393|017|U|ability to control your urination. It helps to reduce leaking of||
0393|018|U|urine, feelings of needing to urinate right away, and frequent||
0393|019|U|trips to the bathroom. This medication belongs to the class of||
0393|020|U|drugs known as antispasmodics.||
0393|021|B|||
0393|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0393|023|H|from your pharmacist before you start using tolterodine and each||
0393|024|H|time you get a refill. If you have any questions, ask your doctor||
0393|025|H|or pharmacist.||
0393|026|H|   Take this medication by mouth with or without food as directed||
0393|027|H|by your doctor, usually once a day. Swallow the medication whole||
0393|028|H|with a full glass of liquid. Do not crush or chew the medication.||
0393|029|H|Doing so can destroy the long action of the drug and may increase||
0393|030|H|side effects.||
0393|031|H|   Use this medication regularly to get the most benefit from it.||
0393|032|H|To help you remember, use it at the same time each day. The||
0393|033|H|dosage is based on your medical condition, response to treatment,||
0393|034|H|and other medications you may be taking. Be sure to tell your||
0393|035|H|doctor and pharmacist about all the products you use (including||
0393|036|H|prescription drugs, nonprescription drugs, and herbal products).||
0393|037|H|Ask your doctor or pharmacist for more details.||
0393|038|H|   Do not increase your dose or take this medication more often||
0393|039|H|than directed. Your condition will not improve any faster and||
0393|040|H|your risk of serious side effects may be increased.||
0393|041|H|   Tell your doctor if your condition lasts or gets worse.||
0393|042|B|||
0393|043|S|SIDE EFFECTS:  Dry mouth, dry eyes, headache, constipation,||
0393|044|S|stomach upset/pain, dizziness, drowsiness, tiredness, or blurred||
0393|045|S|vision may occur. If any of these effects last or get worse, tell||
0393|046|S|your doctor or pharmacist promptly.||
0393|047|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0393|048|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0393|049|S|substitute.||
0393|050|S|   To prevent constipation, eat dietary fiber, drink enough||
0393|051|S|water, and exercise. You may also need to take a laxative. Ask||
0393|052|S|your pharmacist which type of laxative is right for you.||
0393|053|S|   Remember that this medication has been prescribed because your||
0393|054|S|doctor has judged that the benefit to you is greater than the||
0393|055|S|risk of side effects. Many people using this medication do not||
0393|056|S|have serious side effects.||
0393|057|S|   Tell your doctor right away if you have any serious side||
0393|058|S|effects, including: vision changes, severe stomach/abdominal||
0393|059|S|pain, trouble urinating, signs of kidney infection (such as||
0393|060|S|burning/painful urination, lower back pain, fever).||
0393|061|S|   Get medical help right away if you have any very serious side||
0393|062|S|effects, including: fast/slow/irregular heartbeat, severe||
0393|063|S|dizziness, fainting.||
0393|064|S|   A very serious allergic reaction to this drug is rare.||
0393|065|S|However, get medical help right away if you notice any symptoms||
0393|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0393|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0393|068|S|breathing.||
0393|069|S|   This is not a complete list of possible side effects. If you||
0393|070|S|notice other effects not listed above, contact your doctor or||
0393|071|S|pharmacist.||
0393|072|S|   In the US -||
0393|073|S|   Call your doctor for medical advice about side effects. You||
0393|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0393|075|S|www.fda.gov/medwatch.||
0393|076|S|   In Canada - Call your doctor for medical advice about side||
0393|077|S|effects. You may report side effects to Health Canada at||
0393|078|S|1-866-234-2345.||
0393|079|B|||
0393|080|P|PRECAUTIONS:  Before taking tolterodine, tell your doctor or||
0393|081|P|pharmacist if you are allergic to it; or to fesoterodine; or if||
0393|082|P|you have any other allergies. This product may contain inactive||
0393|083|P|ingredients, which can cause allergic reactions or other||
0393|084|P|problems. Talk to your pharmacist for more details.||
0393|085|P|   Before using this medication, tell your doctor or pharmacist||
0393|086|P|your medical history, especially of: problems emptying your||
0393|087|P|bladder (urinary retention, bladder outflow obstruction), severe||
0393|088|P|blockage of stomach/intestines (gastric retention), glaucoma,||
0393|089|P|stomach/intestinal disease (such as ulcerative colitis, slowed||
0393|090|P|movement of stomach/intestines), severe constipation, kidney||
0393|091|P|disease, liver disease, a certain muscle disease (myasthenia||
0393|092|P|gravis).||
0393|093|P|   Tolterodine may cause a condition that affects the heart||
0393|094|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0393|095|P|serious (rarely fatal) fast/irregular heartbeat and other||
0393|096|P|symptoms (such as severe dizziness, fainting) that need medical||
0393|097|P|attention right away.||
0393|098|P|   The risk of QT prolongation may be increased if you have||
0393|099|P|certain medical conditions or are taking other drugs that may||
0393|100|P|cause QT prolongation. Before using tolterodine, tell your doctor||
0393|101|P|or pharmacist of all the drugs you take and if you have any of||
0393|102|P|the following conditions: certain heart problems (heart failure,||
0393|103|P|slow heartbeat, QT prolongation in the EKG), family history of||
0393|104|P|certain heart problems (QT prolongation in the EKG, sudden||
0393|105|P|cardiac death).||
0393|106|P|   Low levels of potassium or magnesium in the blood may also||
0393|107|P|increase your risk of QT prolongation. This risk may increase if||
0393|108|P|you use certain drugs (such as diuretics/"water pills") or if you||
0393|109|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0393|110|P|Talk to your doctor about using tolterodine safely.||
0393|111|P|   This drug may make you dizzy or drowsy or blur your vision.||
0393|112|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0393|113|P|drowsy. Do not drive, use machinery, or do anything that needs||
0393|114|P|alertness or clear vision until you can do it safely. Limit||
0393|115|P|alcoholic beverages. Talk to your doctor if you are using||
0393|116|P|marijuana (cannabis).||
0393|117|P|   This medication may make you sweat less, making you more||
0393|118|P|likely to get heat stroke. Avoid doing things that may cause you||
0393|119|P|to overheat, such as hard work or exercise in hot weather, or||
0393|120|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0393|121|P|and dress lightly. If you overheat, quickly look for a place to||
0393|122|P|cool down and rest. Get medical help right away if you have a||
0393|123|P|fever that does not go away, mental/mood changes, headache, or||
0393|124|P|dizziness.||
0393|125|P|   Before having surgery, tell your doctor or dentist about all||
0393|126|P|the products you use (including prescription drugs,||
0393|127|P|nonprescription drugs, and herbal products).||
0393|128|P|   Older adults may be more sensitive to the side effects of this||
0393|129|P|drug, especially QT prolongation (see above), drowsiness,||
0393|130|P|confusion, constipation, or trouble urinating. Drowsiness and||
0393|131|P|confusion can increase the risk of falling.||
0393|132|P|   During pregnancy, this medication should be used only when||
0393|133|P|clearly needed. Discuss the risks and benefits with your doctor.||
0393|134|P|   It is unknown if this drug passes into breast milk. Consult||
0393|135|P|your doctor before breastfeeding.||
0393|136|B|||
0393|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0393|138|I|medications work or increase your risk for serious side effects.||
0393|139|I|This document does not contain all possible drug interactions.||
0393|140|I|Keep a list of all the products you use (including||
0393|141|I|prescription/nonprescription drugs and herbal products) and share||
0393|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
0393|143|I|the dosage of any medicines without your doctor's approval.||
0393|144|I|   Some products that may interact with this drug include:||
0393|145|I|mifepristone, potassium tablets/capsules, pramlintide.||
0393|146|I|   Many drugs besides tolterodine may affect the heart rhythm (QT||
0393|147|I|prolongation), including amiodarone, dofetilide, pimozide,||
0393|148|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
0393|149|I|erythromycin), among others.||
0393|150|I|   Tell your doctor or pharmacist if you are taking other||
0393|151|I|products that cause drowsiness including alcohol, marijuana||
0393|152|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0393|153|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0393|154|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0393|155|I|codeine).||
0393|156|I|   Check the labels on all your medicines (such as allergy or||
0393|157|I|cough-and-cold products) because they may contain ingredients||
0393|158|I|that cause drowsiness. Ask your pharmacist about using those||
0393|159|I|products safely.||
0393|160|B|||
0393|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0393|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0393|163|O|poison control center right away. US residents can call||
0393|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0393|165|O|Symptoms of overdose may include fast/slow/irregular heartbeat,||
0393|166|O|fainting, unusual excitement, mental/mood changes.||
0393|167|B|||
0393|168|N|NOTES:  Do not share this medication with others.||
0393|169|B|||
0393|170|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0393|171|D|If it is near the time of the next dose, skip the missed dose.||
0393|172|D|Use your next dose at the regular time. Do not double the dose to||
0393|173|D|catch up.||
0393|174|B|||
0393|175|R|STORAGE:  Store at room temperature away from light and moisture.||
0393|176|R|Do not store in the bathroom. Keep all medications away from||
0393|177|R|children and pets.||
0393|178|R|   Do not flush medications down the toilet or pour them into a||
0393|179|R|drain unless instructed to do so. Properly discard this product||
0393|180|R|when it is expired or no longer needed. Consult your pharmacist||
0393|181|R|or local waste disposal company.||
0393|182|B|||
0393|183|A|Information last revised May 2024.||
0393|184|A|Copyright(c) 2025 First Databank, Inc.||
0393|185|B|||
0394|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0394|002|Z|does NOT have all possible information about this product. This||
0394|003|Z|information does not assure that this product is safe, effective,||
0394|004|Z|or appropriate for you. This information is not individual||
0394|005|Z|medical advice and does not substitute for the advice of your||
0394|006|Z|health care professional. Always ask your health care||
0394|007|Z|professional for complete information about this product and your||
0394|008|Z|specific health needs.||
0394|009|B|||
0394|010|T|RISEDRONATE 30 MG - ORAL||
0394|011|F|(RIS-e-DROE-nate)||
0394|012|B|||
0394|013|C|COMMON BRAND NAME(S): Actonel||
0394|014|B|||
0394|015|U|USES:  Risedronate is used by adults to treat a disease that||
0394|016|U|weakens bones (Paget's disease). This medication helps to reduce||
0394|017|U|bone pain and may prevent long-term complications from this||
0394|018|U|disease. Risedronate works by slowing bone loss to help maintain||
0394|019|U|strong bones and reduce the risk of broken bones (fractures). It||
0394|020|U|belongs to a class of medications called bisphosphonates.||
0394|021|B|||
0394|022|V|OTHER USES:  This section contains uses of this drug that are not||
0394|023|V|listed in the approved professional labeling for the drug but||
0394|024|V|that may be prescribed by your health care professional. Use this||
0394|025|V|drug for a condition that is listed in this section only if it||
0394|026|V|has been so prescribed by your health care professional.||
0394|027|V|   This drug may also be used for certain types of bone loss||
0394|028|V|(osteoporosis) in adults. Osteoporosis causes bones to become||
0394|029|V|thinner and break more easily. Your chance of getting||
0394|030|V|osteoporosis goes up as you age, after menopause, or if you are||
0394|031|V|taking corticosteroid medications (such as prednisone) for a long||
0394|032|V|time.||
0394|033|B|||
0394|034|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0394|035|H|Patient Information Leaflet provided by your pharmacist before||
0394|036|H|you start using risedronate and each time you get a refill.||
0394|037|H|Follow the instructions very closely to make sure you absorb as||
0394|038|H|much of the drug as possible and reduce the risk of injury to||
0394|039|H|your esophagus. If you have any questions, ask your doctor or||
0394|040|H|pharmacist.||
0394|041|H|   Take this medication by mouth, after getting up for the day||
0394|042|H|and before taking your first food, beverage, or other medication.||
0394|043|H|Do not take it at bedtime or while you are still in bed.||
0394|044|H|   Take this medication with a full glass of plain water (6 to 8||
0394|045|H|ounces or 180 to 240 milliliters). Do not take it with any other||
0394|046|H|beverage. Swallow the tablet whole. Do not chew or suck on it.||
0394|047|H|Then stay fully upright (sitting, standing, or walking) for at||
0394|048|H|least 30 minutes, and do not lie down until after your first food||
0394|049|H|of the day. Wait at least 30 minutes after taking risedronate||
0394|050|H|before you eat or drink anything other than plain water and||
0394|051|H|before taking any other medication by mouth.||
0394|052|H|   Calcium or iron supplements, vitamins with minerals, antacids||
0394|053|H|containing calcium/magnesium/aluminum, dairy products (such as||
0394|054|H|milk, yogurt), and juice with added calcium may interfere with||
0394|055|H|absorption of risedronate. Medications such as quinapril,||
0394|056|H|sucralfate, and bismuth subsalicylate may also interfere with||
0394|057|H|absorption. Do not take these products for at least 30 minutes||
0394|058|H|after taking risedronate.||
0394|059|H|   Use this medication regularly to get the most benefit from it.||
0394|060|H|For the treatment of Paget's disease, remember to take it at the||
0394|061|H|same time each morning, usually for 2 months.||
0394|062|H|   This drug may also be prescribed once weekly for osteoporosis.||
0394|063|H|Check your prescription label carefully, and ask your doctor or||
0394|064|H|pharmacist if you are uncertain about your dosing schedule. Talk||
0394|065|H|to your doctor about the risks and benefits of long-term use of||
0394|066|H|this medication.||
0394|067|B|||
0394|068|S|SIDE EFFECTS:  Upset stomach may occur. If this effect lasts or||
0394|069|S|gets worse, tell your doctor or pharmacist promptly.||
0394|070|S|   Remember that this medication has been prescribed because your||
0394|071|S|doctor has judged that the benefit to you is greater than the||
0394|072|S|risk of side effects. Many people using this medication do not||
0394|073|S|have serious side effects.||
0394|074|S|   Tell your doctor right away if you have any serious side||
0394|075|S|effects, including: increased or severe bone/joint/muscle pain,||
0394|076|S|new or unusual hip/thigh/groin pain, jaw pain, eye/vision||
0394|077|S|problems.||
0394|078|S|   This medication may rarely cause irritation and ulcers in your||
0394|079|S|stomach or esophagus. Get medical help right away if any of these||
0394|080|S|serious side effects occur: new/severe/worsening heartburn, chest||
0394|081|S|pain, difficult or painful swallowing, severe stomach/abdominal||
0394|082|S|pain, black/tarry stools, vomit that looks like coffee grounds.||
0394|083|S|   A very serious allergic reaction to this drug is rare.||
0394|084|S|However, get medical help right away if you notice any symptoms||
0394|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0394|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0394|087|S|breathing.||
0394|088|S|   This is not a complete list of possible side effects. If you||
0394|089|S|notice other effects not listed above, contact your doctor or||
0394|090|S|pharmacist.||
0394|091|S|   In the US -||
0394|092|S|   Call your doctor for medical advice about side effects. You||
0394|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0394|094|S|www.fda.gov/medwatch.||
0394|095|S|   In Canada - Call your doctor for medical advice about side||
0394|096|S|effects. You may report side effects to Health Canada at||
0394|097|S|1-866-234-2345.||
0394|098|B|||
0394|099|P|PRECAUTIONS:  Before taking risedronate, tell your doctor or||
0394|100|P|pharmacist if you are allergic to it; or to other bisphosphonates||
0394|101|P|(such as alendronate, etidronate, pamidronate); or if you have||
0394|102|P|any other allergies. This product may contain inactive||
0394|103|P|ingredients, which can cause allergic reactions or other||
0394|104|P|problems. Talk to your pharmacist for more details.||
0394|105|P|   Before using this medication, tell your doctor or pharmacist||
0394|106|P|your medical history, especially of: esophagus problems (such as||
0394|107|P|heartburn, narrowing of the esophagus, achalasia), difficult or||
0394|108|P|painful swallowing, low levels of calcium in the blood||
0394|109|P|(hypocalcemia), inability to sit upright or stand for at least 30||
0394|110|P|minutes, stomach/intestinal disorders (such as ulcers), severe||
0394|111|P|kidney disease.||
0394|112|P|   Some people taking risedronate may have serious jawbone||
0394|113|P|problems. Your doctor should check your mouth before you start||
0394|114|P|this medication. Tell your dentist that you are taking this||
0394|115|P|medication before you have any dental work done. To help prevent||
0394|116|P|jawbone problems, have regular dental exams and learn how to keep||
0394|117|P|your teeth and gums healthy. If you have jaw pain, tell your||
0394|118|P|doctor and dentist right away.||
0394|119|P|   Before having any surgery (especially dental procedures), tell||
0394|120|P|your doctor and dentist about this medication and all other||
0394|121|P|products you use (including prescription drugs, nonprescription||
0394|122|P|drugs, and herbal products). Your doctor or dentist may tell you||
0394|123|P|to stop taking risedronate before your surgery. Ask for specific||
0394|124|P|instructions about stopping or starting this medication.||
0394|125|P|   Tell your doctor if you are pregnant or plan to become||
0394|126|P|pregnant. Risedronate may stay in your body for many years. You||
0394|127|P|should not become pregnant while using risedronate. Discuss the||
0394|128|P|risks and benefits with your doctor.||
0394|129|P|   It is unknown if this drug passes into breast milk. Consult||
0394|130|P|your doctor before breastfeeding.||
0394|131|B|||
0394|132|I|DRUG INTERACTIONS:  See also How to Use section.||
0394|133|I|   Drug interactions may change how your medications work or||
0394|134|I|increase your risk for serious side effects. This document does||
0394|135|I|not contain all possible drug interactions. Keep a list of all||
0394|136|I|the products you use (including prescription/nonprescription||
0394|137|I|drugs and herbal products) and share it with your doctor and||
0394|138|I|pharmacist. Do not start, stop, or change the dosage of any||
0394|139|I|medicines without your doctor's approval.||
0394|140|I|   This medication may interfere with certain lab tests (such as||
0394|141|I|bone-imaging tests), possibly causing false test results. Make||
0394|142|I|sure lab personnel and all your doctors know you use this drug.||
0394|143|B|||
0394|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0394|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0394|146|O|poison control center right away. US residents can call||
0394|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0394|148|B|||
0394|149|N|NOTES:  Do not share this medication with others.||
0394|150|N|   Lifestyle changes that help promote healthy bones include||
0394|151|N|increasing weight-bearing exercise, stopping smoking, limiting||
0394|152|N|alcohol, and eating well-balanced meals that contain adequate||
0394|153|N|calcium and vitamin D. Since you may also need to take calcium||
0394|154|N|and vitamin D supplements and make lifestyle changes, consult||
0394|155|N|your doctor for specific advice.||
0394|156|N|   Lab and/or medical tests (x-rays, height, blood mineral||
0394|157|N|levels) should be done while you are taking this medication. Keep||
0394|158|N|all medical and lab appointments. Consult your doctor for more||
0394|159|N|details.||
0394|160|B|||
0394|161|D|MISSED DOSE:  If you take this medication once a day and miss a||
0394|162|D|dose, skip the missed dose. Do not take it later in the day. Take||
0394|163|D|your next dose at the regular time the following day. Do not||
0394|164|D|double the dose to catch up.||
0394|165|D|   If you take this medication once a week and miss a dose, skip||
0394|166|D|the missed dose. Do not take it later in the day. Take it the||
0394|167|D|next morning after you remember. Keep taking your weekly dose on||
0394|168|D|your originally scheduled day of the week. Do not take 2 doses on||
0394|169|D|the same day. Ask your pharmacist if you have any questions.||
0394|170|B|||
0394|171|R|STORAGE:  Store at room temperature away from light and moisture.||
0394|172|R|Do not store in the bathroom. Keep all medications away from||
0394|173|R|children and pets.||
0394|174|R|   Do not flush medications down the toilet or pour them into a||
0394|175|R|drain unless instructed to do so. Properly discard this product||
0394|176|R|when it is expired or no longer needed. Consult your pharmacist||
0394|177|R|or local waste disposal company.||
0394|178|B|||
0394|179|A|Information last revised September 2025.||
0394|180|A|Copyright(c) 2025 First Databank, Inc.||
0394|181|B|||
0395|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0395|002|Z|does NOT have all possible information about this product. This||
0395|003|Z|information does not assure that this product is safe, effective,||
0395|004|Z|or appropriate for you. This information is not individual||
0395|005|Z|medical advice and does not substitute for the advice of your||
0395|006|Z|health care professional. Always ask your health care||
0395|007|Z|professional for complete information about this product and your||
0395|008|Z|specific health needs.||
0395|009|B|||
0395|010|T|RISEDRONATE/CALCIUM - ORAL||
0395|011|F|(RIS-e-DROE-nate/KAL-see-um)||
0395|012|B|||
0395|013|C|COMMON BRAND NAME(S): Actonel with Calcium||
0395|014|B|||
0395|015|U|USES:  This product contains two separate medications:||
0395|016|U|risedronate tablets and calcium tablets.||
0395|017|U|   Risedronate is used to prevent and treat certain types of bone||
0395|018|U|loss (osteoporosis) in adults. Osteoporosis causes bones to||
0395|019|U|become thinner and break (fracture) more easily. Your chance of||
0395|020|U|developing osteoporosis increases as you age, after menopause, or||
0395|021|U|if you are taking corticosteroid medications (such as prednisone)||
0395|022|U|for a long time. This medication works by slowing bone loss to||
0395|023|U|help maintain strong bones and reduce the risk of fractures.||
0395|024|U|Risedronate belongs to a class of medications called||
0395|025|U|bisphosphonates.||
0395|026|U|   Calcium is a mineral needed to form healthy bones and to keep||
0395|027|U|them strong. Calcium supplements are used to make sure you get||
0395|028|U|enough calcium in addition to the calcium you get from a||
0395|029|U|well-balanced diet.||
0395|030|B|||
0395|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0395|032|H|from your pharmacist before you start taking this product and||
0395|033|H|each time you get a refill. Follow the instructions very closely||
0395|034|H|to make sure you absorb as much of the drug as possible and||
0395|035|H|reduce the risk of injury to your esophagus. If you have any||
0395|036|H|questions, ask your doctor or pharmacist.||
0395|037|H|   This product package contains both risedronate and calcium||
0395|038|H|tablets. Calcium can decrease the absorption of risedronate if||
0395|039|H|taken within 30 minutes after it. Take risedronate and calcium on||
0395|040|H|separate days to avoid this drug interaction.||
0395|041|H|   For risedronate: Take this medication by mouth as directed by||
0395|042|H|your doctor, usually once a week. Take it after getting up for||
0395|043|H|the day, before taking your first food, beverage, or other||
0395|044|H|medication. Do not take it at bedtime or while you are still in||
0395|045|H|bed. Take this medication with a full glass of plain water (6 to||
0395|046|H|8 ounces or 180 to 240 milliliters). Do not take it with any||
0395|047|H|other beverages. Swallow the tablet whole. Do not chew or suck on||
0395|048|H|it. Then stay fully upright (sitting, standing, or walking) for||
0395|049|H|at least 30 minutes, and do not lie down until after your first||
0395|050|H|food of the day. Wait at least 30 minutes after taking||
0395|051|H|risedronate before you eat or drink anything other than plain||
0395|052|H|water and before taking any other medication by mouth.||
0395|053|H|   Iron supplements, vitamins with minerals, antacids containing||
0395|054|H|calcium/magnesium/aluminum, dairy products (such as milk,||
0395|055|H|yogurt), and juice with added calcium may interfere with||
0395|056|H|absorption of risedronate. Medications such as quinapril,||
0395|057|H|sucralfate, and bismuth subsalicylate may also interfere with||
0395|058|H|absorption. Do not take these products for at least 30 minutes||
0395|059|H|after taking risedronate.||
0395|060|H|   For calcium: Take the calcium in this product as directed by||
0395|061|H|your doctor, with food for best absorption, usually once daily||
0395|062|H|except for the day you take risedronate.||
0395|063|H|   Use this product regularly in order to get the most benefit||
0395|064|H|from it. Talk to your doctor about the risks and benefits of||
0395|065|H|long-term use of this medication.||
0395|066|B|||
0395|067|S|SIDE EFFECTS:  Upset stomach, nausea, constipation, gas, or||
0395|068|S|bloating may occur. If any of these effects last or get worse,||
0395|069|S|tell your doctor or pharmacist promptly.||
0395|070|S|   Remember that this medication has been prescribed because your||
0395|071|S|doctor has judged that the benefit to you is greater than the||
0395|072|S|risk of side effects. Many people using this medication do not||
0395|073|S|have serious side effects.||
0395|074|S|   Tell your doctor right away if you have any serious side||
0395|075|S|effects, including: increased or severe bone/joint/muscle pain,||
0395|076|S|new or unusual hip/thigh/groin pain, jaw pain, eye/vision||
0395|077|S|problems.||
0395|078|S|   Risedronate may rarely cause irritation and ulcers in your||
0395|079|S|stomach or esophagus. Get medical help right away if any of these||
0395|080|S|serious side effects occur: new/severe/worsening heartburn, chest||
0395|081|S|pain, difficult or painful swallowing, severe stomach/abdominal||
0395|082|S|pain, black/tarry stools, vomit that looks like coffee grounds.||
0395|083|S|   A very serious allergic reaction to this drug is rare.||
0395|084|S|However, get medical help right away if you notice any symptoms||
0395|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0395|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0395|087|S|breathing.||
0395|088|S|   This is not a complete list of possible side effects. If you||
0395|089|S|notice other effects not listed above, contact your doctor or||
0395|090|S|pharmacist.||
0395|091|S|   In the US -||
0395|092|S|   Call your doctor for medical advice about side effects. You||
0395|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0395|094|S|www.fda.gov/medwatch.||
0395|095|S|   In Canada - Call your doctor for medical advice about side||
0395|096|S|effects. You may report side effects to Health Canada at||
0395|097|S|1-866-234-2345.||
0395|098|B|||
0395|099|P|PRECAUTIONS:  Before taking risedronate with calcium, tell your||
0395|100|P|doctor or pharmacist if you are allergic to either of these||
0395|101|P|drugs; or to other bisphosphonates (such as alendronate,||
0395|102|P|etidronate, pamidronate); or if you have any other allergies.||
0395|103|P|This product may contain inactive ingredients, which can cause||
0395|104|P|allergic reactions or other problems. Talk to your pharmacist for||
0395|105|P|more details.||
0395|106|P|   Before using this product, tell your doctor or pharmacist your||
0395|107|P|medical history, especially of: low or high blood calcium levels||
0395|108|P|(hypocalcemia or hypercalcemia), inability to sit upright or||
0395|109|P|stand for at least 30 minutes, esophagus problems (such as||
0395|110|P|narrowing of the esophagus, achalasia), difficult or painful||
0395|111|P|swallowing, kidney problems (such as severe kidney disease,||
0395|112|P|kidney stones), stomach/intestinal disorders (such as ulcers).||
0395|113|P|   Some people taking risedronate may have serious jawbone||
0395|114|P|problems. Your doctor should check your mouth before you start||
0395|115|P|this medication. Tell your dentist that you are taking this||
0395|116|P|medication before you have any dental work done. To help prevent||
0395|117|P|jawbone problems, have regular dental exams and learn how to keep||
0395|118|P|your teeth and gums healthy. If you have jaw pain, tell your||
0395|119|P|doctor and dentist right away.||
0395|120|P|   Before having any surgery (especially dental procedures), tell||
0395|121|P|your doctor and dentist about this medication and all other||
0395|122|P|products you use (including prescription drugs, nonprescription||
0395|123|P|drugs, and herbal products). Your doctor or dentist may tell you||
0395|124|P|to stop taking this medication before your surgery. Ask for||
0395|125|P|specific instructions about stopping or starting this medication.||
0395|126|P|   Tell your doctor if you are pregnant or plan to become||
0395|127|P|pregnant. Risedronate may stay in your body for many years. You||
0395|128|P|should not become pregnant while using risedronate. Discuss the||
0395|129|P|risks and benefits with your doctor.||
0395|130|P|   It is unknown if risedronate passes into breast milk. Consult||
0395|131|P|your doctor before breastfeeding.||
0395|132|B|||
0395|133|I|DRUG INTERACTIONS:  See also How to Use section.||
0395|134|I|   Drug interactions may change how your medications work or||
0395|135|I|increase your risk for serious side effects. This document does||
0395|136|I|not contain all possible drug interactions. Keep a list of all||
0395|137|I|the products you use (including prescription/nonprescription||
0395|138|I|drugs and herbal products) and share it with your doctor and||
0395|139|I|pharmacist. Do not start, stop, or change the dosage of any||
0395|140|I|medicines without your doctor's approval.||
0395|141|I|   Calcium can decrease the absorption of certain drugs,||
0395|142|I|especially if you take them around the same time. These drugs||
0395|143|I|include bisphosphonates (such as alendronate), penicillamine,||
0395|144|I|quinolone antibiotics (such as ciprofloxacin, levofloxacin),||
0395|145|I|tetracycline antibiotics (such as doxycycline, minocycline),||
0395|146|I|thyroid medications (such as levothyroxine), among others. Ask||
0395|147|I|your doctor or pharmacist how long you should wait between doses||
0395|148|I|of the calcium and your other medications and to find a dosing||
0395|149|I|schedule that works for all your medications.||
0395|150|I|   This medication may interfere with certain lab tests (such as||
0395|151|I|bone-imaging tests), possibly causing false test results. Make||
0395|152|I|sure lab personnel and all your doctors know you use this drug.||
0395|153|B|||
0395|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0395|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0395|156|O|poison control center right away. US residents can call||
0395|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0395|158|B|||
0395|159|N|NOTES:  Do not share this product with others.||
0395|160|N|   Lifestyle changes that help promote healthy bones include||
0395|161|N|increasing weight-bearing exercise, stopping smoking, limiting||
0395|162|N|alcohol, and eating well-balanced meals that contain adequate||
0395|163|N|calcium and vitamin D. Since you may also need to take calcium||
0395|164|N|and vitamin D supplements and make lifestyle changes, consult||
0395|165|N|your doctor for specific advice.||
0395|166|N|   Lab and/or medical tests (x-rays, height, blood mineral||
0395|167|N|levels) should be done while you are taking this medication. Keep||
0395|168|N|all medical and lab appointments. Consult your doctor for more||
0395|169|N|details.||
0395|170|B|||
0395|171|D|MISSED DOSE:  If you miss a dose of risedronate, do not take it||
0395|172|D|later in the day. Take it the next morning after you remember.||
0395|173|D|Take that day's calcium at a later time, with food. Keep taking||
0395|174|D|your weekly dose of risedronate on your originally scheduled day||
0395|175|D|of the week. Do not take two doses on the same day. Consult your||
0395|176|D|doctor or pharmacist if you have any questions.||
0395|177|D|   If you miss a dose of calcium, take it as soon as you||
0395|178|D|remember. If it is near the time of the next dose, skip the||
0395|179|D|missed dose. Take your next dose at the regular time. Do not||
0395|180|D|double the dose of calcium to catch up unless your doctor directs||
0395|181|D|you otherwise.||
0395|182|B|||
0395|183|R|STORAGE:  Store at room temperature away from light and moisture.||
0395|184|R|Do not store in the bathroom. Keep all medications away from||
0395|185|R|children and pets.||
0395|186|R|   Do not flush medications down the toilet or pour them into a||
0395|187|R|drain unless instructed to do so. Properly discard this product||
0395|188|R|when it is expired or no longer needed. Consult your pharmacist||
0395|189|R|or local waste disposal company.||
0395|190|B|||
0395|191|A|Information last revised October 2025.||
0395|192|A|Copyright(c) 2025 First Databank, Inc.||
0395|193|B|||
0396|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0396|002|Z|does NOT have all possible information about this product. This||
0396|003|Z|information does not assure that this product is safe, effective,||
0396|004|Z|or appropriate for you. This information is not individual||
0396|005|Z|medical advice and does not substitute for the advice of your||
0396|006|Z|health care professional. Always ask your health care||
0396|007|Z|professional for complete information about this product and your||
0396|008|Z|specific health needs.||
0396|009|B|||
0396|010|T|TOBRAMYCIN DROPS - OPHTHALMIC||
0396|011|F|(TOE-bra-MYE-sin)||
0396|012|B|||
0396|013|C|COMMON BRAND NAME(S): Tobrex||
0396|014|B|||
0396|015|U|USES:  This medication is used to treat eye infections.||
0396|016|U|Tobramycin belongs to a class of drugs called aminoglycoside||
0396|017|U|antibiotics. It works by stopping the growth of bacteria.||
0396|018|U|   This medication treats only bacterial eye infections. It will||
0396|019|U|not work for other types of eye infections. Unnecessary use or||
0396|020|U|overuse of any antibiotic can lead to its decreased||
0396|021|U|effectiveness.||
0396|022|B|||
0396|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0396|024|H|directed by your doctor, usually every 4 hours.||
0396|025|H|   To apply eye drops, wash your hands first. To avoid||
0396|026|H|contamination, do not touch the dropper tip or let it touch your||
0396|027|H|eye or any other surface.||
0396|028|H|   Do not wear contact lenses while you are using this medicine.||
0396|029|H|Sterilize contact lenses according to manufacturer's directions||
0396|030|H|and check with your doctor before using them.||
0396|031|H|   Tilt your head back, look upward and pull down the lower||
0396|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0396|033|H|and place one drop into the pouch. Look downward and gently close||
0396|034|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0396|035|H|your eye (near the nose) and apply gentle pressure. This will||
0396|036|H|prevent the medication from draining out. Try not to blink and do||
0396|037|H|not rub your eye. Repeat these steps for your other eye if so||
0396|038|H|directed, and if your dose is for more than 1 drop.||
0396|039|H|   Do not rinse the dropper. Replace the dropper cap after each||
0396|040|H|use.||
0396|041|H|   If you are using another kind of eye medication (such as drops||
0396|042|H|or ointments), wait at least 5 to 10 minutes before applying||
0396|043|H|other medications. Use eye drops before eye ointments to allow||
0396|044|H|the eye drops to enter the eye.||
0396|045|H|   Wait several minutes for your vision to clear before driving||
0396|046|H|or operating machinery.||
0396|047|H|   Use this medication regularly in order to get the most benefit||
0396|048|H|from it. To help you remember, use this medication at the same||
0396|049|H|times each day. Continue to use this medication for the full time||
0396|050|H|prescribed, even if symptoms disappear after a few days. Stopping||
0396|051|H|the medication too early may result in a return of the infection.||
0396|052|H|   Tell your doctor if your condition lasts or gets worse.||
0396|053|B|||
0396|054|S|SIDE EFFECTS:  Tearing, eye redness, eye discomfort, or eyelid||
0396|055|S|itching/swelling may occur. If any of these effects last or get||
0396|056|S|worse, notify your doctor or pharmacist promptly.||
0396|057|S|   Remember that this medication has been prescribed because your||
0396|058|S|doctor has judged that the benefit to you is greater than the||
0396|059|S|risk of side effects. Many people using this medication do not||
0396|060|S|have serious side effects.||
0396|061|S|   Use of this medication for prolonged or repeated periods may||
0396|062|S|result in a new fungal eye infection. Do not use it for longer||
0396|063|S|than prescribed. Contact your doctor if you notice new or||
0396|064|S|worsening symptoms.||
0396|065|S|   A very serious allergic reaction to this drug is rare.||
0396|066|S|However, get medical help right away if you notice any symptoms||
0396|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0396|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0396|069|S|breathing.||
0396|070|S|   This is not a complete list of possible side effects. If you||
0396|071|S|notice other effects not listed above, contact your doctor or||
0396|072|S|pharmacist.||
0396|073|S|   In the US -||
0396|074|S|   Call your doctor for medical advice about side effects. You||
0396|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0396|076|S|www.fda.gov/medwatch.||
0396|077|S|   In Canada - Call your doctor for medical advice about side||
0396|078|S|effects. You may report side effects to Health Canada at||
0396|079|S|1-866-234-2345.||
0396|080|B|||
0396|081|P|PRECAUTIONS:  Before using tobramycin, tell your doctor or||
0396|082|P|pharmacist if you are allergic to it; or to other aminoglycosides||
0396|083|P|(such as gentamicin); or if you have any other allergies. This||
0396|084|P|product may contain inactive ingredients (such as preservatives||
0396|085|P|like benzalkonium chloride), which can cause allergic reactions||
0396|086|P|or other problems. Talk to your pharmacist for more details.||
0396|087|P|   Before using this medication, tell your doctor or pharmacist||
0396|088|P|your medical history, especially of: other eye problems.||
0396|089|P|   After you apply this drug, your vision may become temporarily||
0396|090|P|blurred or unstable. Do not drive, use machinery, or do anything||
0396|091|P|that needs clear vision until you can do it safely.||
0396|092|P|   During pregnancy, this medication should be used only when||
0396|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
0396|094|P|   It is unknown if this medication passes into breast milk.||
0396|095|P|Consult your doctor before breastfeeding.||
0396|096|B|||
0396|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0396|098|I|medications work or increase your risk for serious side effects.||
0396|099|I|This document does not contain all possible drug interactions.||
0396|100|I|Keep a list of all the products you use (including||
0396|101|I|prescription/nonprescription drugs and herbal products) and share||
0396|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
0396|103|I|the dosage of any medicines without your doctor's approval.||
0396|104|B|||
0396|105|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0396|106|O|has overdosed and has serious symptoms such as passing out or||
0396|107|O|trouble breathing, call 911. Otherwise, call a poison control||
0396|108|O|center right away. US residents can call 1-800-222-1222. Canada||
0396|109|O|residents can call 1-844-764-7669.||
0396|110|B|||
0396|111|N|NOTES:  Do not share this medication with others.||
0396|112|N|   This medication has been prescribed for your current condition||
0396|113|N|only. Throw away the unused medication after treatment is||
0396|114|N|completed. Do not use it later for another infection unless your||
0396|115|N|doctor tells you to.||
0396|116|B|||
0396|117|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0396|118|D|If it is near the time of the next dose, skip the missed dose.||
0396|119|D|Use your next dose at the regular time. Do not double the dose to||
0396|120|D|catch up.||
0396|121|B|||
0396|122|R|STORAGE:  Different brands of this medication have different||
0396|123|R|storage needs. Check the product package for instructions on how||
0396|124|R|to store your brand, or ask your pharmacist. Keep all medications||
0396|125|R|away from children and pets.||
0396|126|R|   Do not flush medications down the toilet or pour them into a||
0396|127|R|drain unless instructed to do so. Properly discard this product||
0396|128|R|when it is expired or no longer needed. Consult your pharmacist||
0396|129|R|or local waste disposal company.||
0396|130|B|||
0396|131|A|Information last revised October 2024.||
0396|132|A|Copyright(c) 2025 First Databank, Inc.||
0396|133|B|||
0397|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0397|002|Z|does NOT have all possible information about this product. This||
0397|003|Z|information does not assure that this product is safe, effective,||
0397|004|Z|or appropriate for you. This information is not individual||
0397|005|Z|medical advice and does not substitute for the advice of your||
0397|006|Z|health care professional. Always ask your health care||
0397|007|Z|professional for complete information about this product and your||
0397|008|Z|specific health needs.||
0397|009|B|||
0397|010|T|TOBRAMYCIN OINTMENT - OPHTHALMIC||
0397|011|F|(TOE-bra-MYE-sin)||
0397|012|B|||
0397|013|C|COMMON BRAND NAME(S): Tobrex||
0397|014|B|||
0397|015|U|USES:  This medication is used to treat eye infections.||
0397|016|U|Tobramycin belongs to a class of drugs called aminoglycoside||
0397|017|U|antibiotics. It works by stopping the growth of bacteria.||
0397|018|U|   This medication treats only bacterial eye infections. It will||
0397|019|U|not work for other types of eye infections. Unnecessary use or||
0397|020|U|overuse of any antibiotic can lead to its decreased||
0397|021|U|effectiveness.||
0397|022|B|||
0397|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0397|024|H|directed by your doctor, usually 2 to 3 times a day.||
0397|025|H|   Do not wear contact lenses while you are using this medicine.||
0397|026|H|Sterilize contact lenses according to manufacturer's directions||
0397|027|H|and check with your doctor before using them.||
0397|028|H|   To apply eye ointments, wash hands first. To avoid||
0397|029|H|contamination, do not touch the tube tip or let it touch your eye||
0397|030|H|or any other surface.||
0397|031|H|   Tilt your head back, look upward and pull down your lower||
0397|032|H|eyelid to make a pouch. Place a 1/2 inch (1.3 centimeters) strip||
0397|033|H|of ointment into the pouch by squeezing the tube gently. Look||
0397|034|H|downward and gently close your eyes for 1 to 2 minutes. Roll your||
0397|035|H|eyeball in all directions to spread the medication. Try not to||
0397|036|H|blink and do not rub your eye. Repeat these steps for your other||
0397|037|H|eye if so directed.||
0397|038|H|   Wipe the tip of the ointment tube with a clean tissue to||
0397|039|H|remove excess medication before recapping it.||
0397|040|H|   If you are using another kind of eye medication (such as drops||
0397|041|H|or other ointments), wait at least 5 to 10 minutes before||
0397|042|H|applying other medications. Use eye drops before eye ointments to||
0397|043|H|allow the eye drops to enter the eye.||
0397|044|H|   Wait several minutes for your vision to clear before driving||
0397|045|H|or operating machinery.||
0397|046|H|   Use this medication regularly in order to get the most benefit||
0397|047|H|from it. To help you remember, use this medication at the same||
0397|048|H|times each day. Continue to use this medication for the full time||
0397|049|H|prescribed, even if symptoms disappear after a few days. Stopping||
0397|050|H|the medication too early may result in a return of the infection.||
0397|051|H|   Tell your doctor if your condition lasts or gets worse.||
0397|052|B|||
0397|053|S|SIDE EFFECTS:  Temporary blurred vision, tearing, eye redness,||
0397|054|S|eye discomfort, or eyelid itching/swelling may occur. If any of||
0397|055|S|these effects last or get worse, notify your doctor or pharmacist||
0397|056|S|promptly.||
0397|057|S|   Remember that this medication has been prescribed because your||
0397|058|S|doctor has judged that the benefit to you is greater than the||
0397|059|S|risk of side effects. Many people using this medication do not||
0397|060|S|have serious side effects.||
0397|061|S|   Use of this medication for prolonged or repeated periods may||
0397|062|S|result in a new fungal eye infection. Do not use it for longer||
0397|063|S|than prescribed. Contact your doctor if you notice new or||
0397|064|S|worsening symptoms.||
0397|065|S|   A very serious allergic reaction to this drug is rare.||
0397|066|S|However, get medical help right away if you notice any symptoms||
0397|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0397|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0397|069|S|breathing.||
0397|070|S|   This is not a complete list of possible side effects. If you||
0397|071|S|notice other effects not listed above, contact your doctor or||
0397|072|S|pharmacist.||
0397|073|S|   In the US -||
0397|074|S|   Call your doctor for medical advice about side effects. You||
0397|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0397|076|S|www.fda.gov/medwatch.||
0397|077|S|   In Canada - Call your doctor for medical advice about side||
0397|078|S|effects. You may report side effects to Health Canada at||
0397|079|S|1-866-234-2345.||
0397|080|B|||
0397|081|P|PRECAUTIONS:  Before using tobramycin, tell your doctor or||
0397|082|P|pharmacist if you are allergic to it; or to other aminoglycosides||
0397|083|P|(such as gentamicin); or if you have any other allergies. This||
0397|084|P|product may contain inactive ingredients, which can cause||
0397|085|P|allergic reactions or other problems. Talk to your pharmacist for||
0397|086|P|more details.||
0397|087|P|   Before using this medication, tell your doctor or pharmacist||
0397|088|P|your medical history, especially of: other eye problems.||
0397|089|P|   After you apply this drug, your vision may become temporarily||
0397|090|P|blurred or unstable. Do not drive, use machinery, or do anything||
0397|091|P|that needs clear vision until you can do it safely.||
0397|092|P|   During pregnancy, this medication should be used only when||
0397|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
0397|094|P|   It is unknown if this medication passes into breast milk.||
0397|095|P|Consult your doctor before breastfeeding.||
0397|096|B|||
0397|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0397|098|I|medications work or increase your risk for serious side effects.||
0397|099|I|This document does not contain all possible drug interactions.||
0397|100|I|Keep a list of all the products you use (including||
0397|101|I|prescription/nonprescription drugs and herbal products) and share||
0397|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
0397|103|I|the dosage of any medicines without your doctor's approval.||
0397|104|B|||
0397|105|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0397|106|O|has overdosed and has serious symptoms such as passing out or||
0397|107|O|trouble breathing, call 911. Otherwise, call a poison control||
0397|108|O|center right away. US residents can call 1-800-222-1222. Canada||
0397|109|O|residents can call 1-844-764-7669.||
0397|110|B|||
0397|111|N|NOTES:  Do not share this medication with others.||
0397|112|N|   This medication has been prescribed for your current condition||
0397|113|N|only. Throw away the unused medication after treatment is||
0397|114|N|completed. Do not use it later for another infection unless your||
0397|115|N|doctor tells you to.||
0397|116|B|||
0397|117|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0397|118|D|If it is near the time of the next dose, skip the missed dose.||
0397|119|D|Use your next dose at the regular time. Do not double the dose to||
0397|120|D|catch up.||
0397|121|B|||
0397|122|R|STORAGE:  Different brands of this medication have different||
0397|123|R|storage needs. Check the product package for instructions on how||
0397|124|R|to store your brand, or ask your pharmacist Keep all medications||
0397|125|R|away from children and pets.||
0397|126|R|   Do not flush medications down the toilet or pour them into a||
0397|127|R|drain unless instructed to do so. Properly discard this product||
0397|128|R|when it is expired or no longer needed. Consult your pharmacist||
0397|129|R|or local waste disposal company.||
0397|130|B|||
0397|131|A|Information last revised November 2024.||
0397|132|A|Copyright(c) 2025 First Databank, Inc.||
0397|133|B|||
0398|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0398|002|Z|does NOT have all possible information about this product. This||
0398|003|Z|information does not assure that this product is safe, effective,||
0398|004|Z|or appropriate for you. This information is not individual||
0398|005|Z|medical advice and does not substitute for the advice of your||
0398|006|Z|health care professional. Always ask your health care||
0398|007|Z|professional for complete information about this product and your||
0398|008|Z|specific health needs.||
0398|009|B|||
0398|010|T|RAMELTEON - ORAL||
0398|011|F|(ra-MEL-tee-on)||
0398|012|B|||
0398|013|C|COMMON BRAND NAME(S): Rozerem||
0398|014|B|||
0398|015|U|USES:  This medication is used to treat sleeplessness (insomnia).||
0398|016|U|It helps you fall asleep faster so you can get a full night's||
0398|017|U|rest. Sleep is important for your ability to function, think||
0398|018|U|clearly, and remain alert. Lack of sleep can cause problems such||
0398|019|U|as depression, heart disease and accidents. Getting enough sleep||
0398|020|U|allows your mind and body to repair itself and increases your||
0398|021|U|energy throughout the day.||
0398|022|U|   Ramelteon works like a natural substance called melatonin that||
0398|023|U|is produced by your body. It helps regulate your sleep-wake cycle||
0398|024|U|(circadian rhythm).||
0398|025|B|||
0398|026|H|HOW TO USE:  Read the Medication Guide provided by your||
0398|027|H|pharmacist before you start taking ramelteon and each time you||
0398|028|H|get a refill. If you have any questions, ask your doctor or||
0398|029|H|pharmacist.||
0398|030|H|   Take this medication by mouth with or without food as directed||
0398|031|H|by your doctor, usually 30 minutes before bedtime. Do not take||
0398|032|H|ramelteon with or immediately after a high-fat meal because fat||
0398|033|H|can affect how well this drug works.||
0398|034|H|   The manufacturer directs not to break the tablet before taking||
0398|035|H|it. However, many similar drugs (immediate-release tablets) can||
0398|036|H|be broken. Follow your doctor's directions on how to take this||
0398|037|H|medication.||
0398|038|H|   Do not take a dose of this medication unless you have time for||
0398|039|H|a full night's sleep that lasts at least 7 to 8 hours.||
0398|040|H|   The dosage is based on your medical condition and response to||
0398|041|H|treatment. Do not increase your dose or take it more often than||
0398|042|H|prescribed.||
0398|043|H|   Tell your doctor if you have any changes in mood (such as||
0398|044|H|feelings of depression), if you continue to have trouble falling||
0398|045|H|asleep, or if your insomnia gets worse.||
0398|046|B|||
0398|047|S|SIDE EFFECTS:  Dizziness, tiredness, or daytime drowsiness may||
0398|048|S|occur. If any of these effects last or get worse, notify your||
0398|049|S|doctor or pharmacist promptly.||
0398|050|S|   Remember that this medication has been prescribed because your||
0398|051|S|doctor has judged that the benefit to you is greater than the||
0398|052|S|risk of side effects. Many people using this medication do not||
0398|053|S|have serious side effects.||
0398|054|S|   Some people who take sleep medications have reported getting||
0398|055|S|out of bed and sleep-walking, driving, eating, talking on the||
0398|056|S|phone, or doing other activities while not fully awake. Often,||
0398|057|S|they have no memory of these activities. This problem can be||
0398|058|S|dangerous to you or others. If you have or think you have this||
0398|059|S|problem, tell your doctor right away. Your risk is increased if||
0398|060|S|you use alcohol or other medications that can make you drowsy.||
0398|061|S|   Tell your doctor right away if you have any serious side||
0398|062|S|effects, including: mental/mood changes (such as depression,||
0398|063|S|strange thoughts, thoughts of suicide), decreased sexual desire,||
0398|064|S|missed menstrual periods, nipple discharge, difficulty becoming||
0398|065|S|pregnant.||
0398|066|S|   A very serious allergic reaction to this drug is rare.||
0398|067|S|However, get medical help right away if you notice any symptoms||
0398|068|S|of a serious allergic reaction, including: rash, itching/swelling||
0398|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0398|070|S|breathing.||
0398|071|S|   This is not a complete list of possible side effects. If you||
0398|072|S|notice other effects not listed above, contact your doctor or||
0398|073|S|pharmacist.||
0398|074|S|   In the US -||
0398|075|S|   Call your doctor for medical advice about side effects. You||
0398|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0398|077|S|www.fda.gov/medwatch.||
0398|078|S|   In Canada - Call your doctor for medical advice about side||
0398|079|S|effects. You may report side effects to Health Canada at||
0398|080|S|1-866-234-2345.||
0398|081|B|||
0398|082|P|PRECAUTIONS:  Before taking ramelteon, tell your doctor or||
0398|083|P|pharmacist if you are allergic to it; or if you have any other||
0398|084|P|allergies. This product may contain inactive ingredients, which||
0398|085|P|can cause allergic reactions or other problems. Talk to your||
0398|086|P|pharmacist for more details.||
0398|087|P|   Before using this medication, tell your doctor or pharmacist||
0398|088|P|your medical history, especially of: breathing problems||
0398|089|P|(bronchitis, emphysema, sleep apnea), liver disease.||
0398|090|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0398|091|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0398|092|P|machinery, or do anything that needs alertness until you can do||
0398|093|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0398|094|P|are using marijuana (cannabis). Alcohol may increase the risk of||
0398|095|P|this drug's side effects and can worsen sleeping problems.||
0398|096|P|   Before having surgery, tell your doctor or dentist about all||
0398|097|P|the products you use (including prescription drugs,||
0398|098|P|nonprescription drugs, and herbal products).||
0398|099|P|   During pregnancy, this medication should be used only when||
0398|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0398|101|P|   It is unknown if this medication passes into breast milk.||
0398|102|P|Because of the possible risk to the infant (such as unusual||
0398|103|P|sleepiness or difficulty feeding), ask your doctor if you should||
0398|104|P|pump and discard your breast milk during treatment and for 25||
0398|105|P|hours after a dose of this medication to lessen the risk of these||
0398|106|P|effects in your baby. Get medical help right away if you notice||
0398|107|P|any unusual symptoms in your baby. Consult your doctor before||
0398|108|P|breastfeeding.||
0398|109|B|||
0398|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0398|111|I|medications work or increase your risk for serious side effects.||
0398|112|I|This document does not contain all possible drug interactions.||
0398|113|I|Keep a list of all the products you use (including||
0398|114|I|prescription/nonprescription drugs and herbal products) and share||
0398|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
0398|116|I|the dosage of any medicines without your doctor's approval.||
0398|117|I|   Other medications can affect the removal of ramelteon from||
0398|118|I|your body, which may affect how ramelteon works. Examples include||
0398|119|I|azole antifungals (such as fluconazole, ketoconazole),||
0398|120|I|fluvoxamine, rifamycins (such as rifampin), viloxazine, among||
0398|121|I|others.||
0398|122|I|   Tell your doctor or pharmacist if you are taking other||
0398|123|I|products that cause drowsiness such as opioid pain or cough||
0398|124|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0398|125|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0398|126|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0398|127|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0398|128|I|diphenhydramine).||
0398|129|I|   Check the labels on all your medicines (such as allergy or||
0398|130|I|cough-and-cold products) because they may contain ingredients||
0398|131|I|that cause drowsiness. Ask your pharmacist about using those||
0398|132|I|products safely.||
0398|133|B|||
0398|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0398|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0398|136|O|poison control center right away. US residents can call||
0398|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0398|138|B|||
0398|139|N|NOTES:  Do not share this medication with others.||
0398|140|N|   Lab and/or medical tests (such as hormone levels) may be done||
0398|141|N|while you are taking this medication. Keep all medical and lab||
0398|142|N|appointments. Consult your doctor for more details.||
0398|143|N|   Lifestyle changes that can help you get to sleep include||
0398|144|N|reducing stress, not smoking, avoiding caffeine and alcoholic||
0398|145|N|beverages for at least 4 to 6 hours before bedtime, listening to||
0398|146|N|relaxing music, and doing relaxation exercises. Get up and go to||
0398|147|N|bed at the same time each day. Don't take naps during the day,||
0398|148|N|and make sure your bedroom is quiet and comfortable.||
0398|149|B|||
0398|150|D|MISSED DOSE:  Not applicable.||
0398|151|B|||
0398|152|R|STORAGE:  Store at room temperature away from light and moisture.||
0398|153|R|Do not store in the bathroom. Keep all medications away from||
0398|154|R|children and pets.||
0398|155|R|   Do not flush medications down the toilet or pour them into a||
0398|156|R|drain unless instructed to do so. Properly discard this product||
0398|157|R|when it is expired or no longer needed. Consult your pharmacist||
0398|158|R|or local waste disposal company.||
0398|159|B|||
0398|160|A|Information last revised October 2024.||
0398|161|A|Copyright(c) 2025 First Databank, Inc.||
0398|162|B|||
0399|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0399|002|Z|does NOT have all possible information about this product. This||
0399|003|Z|information does not assure that this product is safe, effective,||
0399|004|Z|or appropriate for you. This information is not individual||
0399|005|Z|medical advice and does not substitute for the advice of your||
0399|006|Z|health care professional. Always ask your health care||
0399|007|Z|professional for complete information about this product and your||
0399|008|Z|specific health needs.||
0399|009|B|||
0399|010|T|EMTRICITABINE/TENOFOVIR - ORAL||
0399|011|F|(EM-trye-SYE-ta-been/ten-OF-oh-vir)||
0399|012|B|||
0399|013|C|COMMON BRAND NAME(S): Truvada||
0399|014|B|||
0399|015|W|WARNING:  If you have hepatitis B infection as well as HIV, your||
0399|016|W|hepatitis symptoms may get worse or become very serious if you||
0399|017|W|stop taking this medication. Talk with your doctor before||
0399|018|W|stopping this medication. Your doctor will perform liver function||
0399|019|W|tests for several months after you stop.||
0399|020|W|   If you are taking this product to prevent HIV infection, you||
0399|021|W|must first get tested to be sure you are HIV-negative. Your||
0399|022|W|doctor will perform lab tests before starting this medication and||
0399|023|W|periodically during treatment (every 3 months) to make sure that||
0399|024|W|you do not have HIV infection. Using this product will not always||
0399|025|W|prevent HIV infection. To get the most benefit from it, take this||
0399|026|W|product exactly as directed, and follow all prevention actions.||
0399|027|W|(See also Uses section.) Tell your doctor right away if you have||
0399|028|W|any signs of HIV infection (such as sore throat that doesn't go||
0399|029|W|away, tiredness, fever, night sweats, diarrhea, joint/muscle||
0399|030|W|aches, enlarged lymph nodes).||
0399|031|B|||
0399|032|U|USES:  This product is used with other HIV medications to help||
0399|033|U|control HIV infection. It helps to decrease the amount of HIV in||
0399|034|U|your body so your immune system can work better. This lowers your||
0399|035|U|chance of getting HIV complications (such as new infections,||
0399|036|U|cancer) and improves your quality of life. This product is a||
0399|037|U|combination of two different drugs: emtricitabine and tenofovir.||
0399|038|U|Emtricitabine is called a nucleoside reverse transcriptase||
0399|039|U|inhibitor, while tenofovir is called a nucleotide reverse||
0399|040|U|transcriptase inhibitor. They are often called NRTIs.||
0399|041|U|   This product should not be used by itself to help control HIV||
0399|042|U|infection. Doing so can make your treatment less effective.||
0399|043|U|Combination treatment with at least one other HIV medication||
0399|044|U|should be used.||
0399|045|U|   This product is also used to help prevent HIV infection in||
0399|046|U|people who have a high risk for infection. Some things that||
0399|047|U|increase risk include having a partner infected with HIV, having||
0399|048|U|unprotected sex, having multiple sex partners, infection with a||
0399|049|U|sexually transmitted disease-STD, or use/abuse of drugs or||
0399|050|U|alcohol.||
0399|051|U|   Emtricitabine/tenofovir is not a cure for HIV infection. To||
0399|052|U|decrease your risk of spreading HIV disease to others, continue||
0399|053|U|to take all HIV medications exactly as prescribed by your doctor.||
0399|054|U|Use an effective barrier method (latex or polyurethane||
0399|055|U|condoms/dental dams) during sexual activity as directed by your||
0399|056|U|doctor. Do not share personal items (such as needles/syringes,||
0399|057|U|toothbrushes, and razors) that may have contacted blood or other||
0399|058|U|body fluids. Consult your doctor or pharmacist for more details.||
0399|059|B|||
0399|060|V|OTHER USES:  This section contains uses of this drug that are not||
0399|061|V|listed in the approved professional labeling for the drug but||
0399|062|V|that may be prescribed by your health care professional. Use this||
0399|063|V|drug for a condition that is listed in this section only if it||
0399|064|V|has been so prescribed by your health care professional.||
0399|065|V|   This product may also be used to lessen the risk of HIV||
0399|066|V|infection after contact with the virus (for example, due to a||
0399|067|V|needle stick). Ask your doctor for more details.||
0399|068|B|||
0399|069|H|HOW TO USE:  Read the Medication Guide provided by your||
0399|070|H|pharmacist before you start taking this medication and each time||
0399|071|H|you get a refill. If you have any questions, ask your doctor or||
0399|072|H|pharmacist.||
0399|073|H|   Take this medication by mouth as directed by your doctor,||
0399|074|H|usually once daily with or without food. The dosage is based on||
0399|075|H|your medical condition and response to treatment. Children's||
0399|076|H|dosage is also based on weight.||
0399|077|H|   When used to treat HIV infection, this product is taken with||
0399|078|H|other medicines that treat HIV. If you are also taking didanosine||
0399|079|H|enteric-coated tablets, take both products either on an empty||
0399|080|H|stomach or with a light meal. If you are taking the didanosine||
0399|081|H|buffered tablets, take both drug products on an empty stomach.||
0399|082|H|   It is very important to keep taking this medication (and other||
0399|083|H|HIV medications) exactly as prescribed by your doctor. Do not||
0399|084|H|skip any doses.||
0399|085|H|   For the best effect, take this medication at evenly spaced||
0399|086|H|times. To help you remember, take this medication at the same||
0399|087|H|time every day.||
0399|088|H|   Do not take more or less of this drug than prescribed or stop||
0399|089|H|taking it (or other HIV medicines) even for a short time unless||
0399|090|H|directed to do so by your doctor. Doing so may cause the amount||
0399|091|H|of virus to increase, make the infection more difficult to treat||
0399|092|H|(resistant), or worsen side effects.||
0399|093|B|||
0399|094|S|SIDE EFFECTS:  Diarrhea, headache, dizziness, trouble sleeping,||
0399|095|S|back pain, or change in the color of skin on your palms or soles||
0399|096|S|of your feet may occur. If any of these effects last or get||
0399|097|S|worse, tell your doctor or pharmacist promptly.||
0399|098|S|   Remember that this medication has been prescribed because your||
0399|099|S|doctor has judged that the benefit to you is greater than the||
0399|100|S|risk of side effects. Many people using this medication do not||
0399|101|S|have serious side effects.||
0399|102|S|   As your immune system gets stronger with HIV treatment, it can||
0399|103|S|begin to fight off infections you already had, possibly causing||
0399|104|S|disease symptoms to come back. You could also have symptoms if||
0399|105|S|your immune system becomes overactive. This reaction may happen||
0399|106|S|at any time (soon after starting HIV treatment or many months||
0399|107|S|later). Tell your doctor right away if you have any serious||
0399|108|S|symptoms, including: unexplained weight loss, severe tiredness,||
0399|109|S|muscle aches/weakness that doesn't go away, headaches that are||
0399|110|S|severe or don't go away, joint pain, numbness/tingling of the||
0399|111|S|hands/feet/arms/legs, vision changes, signs of infection (such as||
0399|112|S|sore throat the doesn't go away, fever, chills, swollen lymph||
0399|113|S|nodes, non-healing skin sores), signs of an overactive thyroid||
0399|114|S|(such as irritability, nervousness, heat intolerance,||
0399|115|S|fast/pounding/irregular heartbeat).||
0399|116|S|   Tell your doctor right away if you have any serious side||
0399|117|S|effects, including: mental/mood changes (such as depression,||
0399|118|S|anxiety), signs of kidney problems (such as change in the amount||
0399|119|S|of urine, pink/bloody urine).||
0399|120|S|   Rarely, this medication can cause severe (sometimes fatal)||
0399|121|S|liver and blood problems (lactic acidosis). Tell your doctor||
0399|122|S|right away if you develop symptoms of liver problems (such as||
0399|123|S|nausea/vomiting that doesn't stop, loss of appetite,||
0399|124|S|stomach/abdominal pain, yellowing eyes/skin, dark urine) or||
0399|125|S|lactic acidosis (such as deep/rapid breathing, drowsiness,||
0399|126|S|nausea/vomiting, unusual weakness).||
0399|127|S|   Tenofovir may increase the risk of bone loss. Discuss the||
0399|128|S|risks and benefits of treatment with your doctor, as well as the||
0399|129|S|possible use of calcium and vitamin D to reduce this side effect.||
0399|130|S|If you are at risk for bone loss, your doctor may monitor your||
0399|131|S|bone mineral density. Tell your doctor right away if any of the||
0399|132|S|following serious side effects occur: bone pain, easily broken||
0399|133|S|bones.||
0399|134|S|   A very serious allergic reaction to this drug is rare.||
0399|135|S|However, get medical help right away if you notice any symptoms||
0399|136|S|of a serious allergic reaction, including: rash, itching/swelling||
0399|137|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0399|138|S|breathing.||
0399|139|S|   This is not a complete list of possible side effects. If you||
0399|140|S|notice other effects not listed above, contact your doctor or||
0399|141|S|pharmacist.||
0399|142|S|   In the US -||
0399|143|S|   Call your doctor for medical advice about side effects. You||
0399|144|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0399|145|S|www.fda.gov/medwatch.||
0399|146|S|   In Canada - Call your doctor for medical advice about side||
0399|147|S|effects. You may report side effects to Health Canada at||
0399|148|S|1-866-234-2345.||
0399|149|B|||
0399|150|P|PRECAUTIONS:  Before taking emtricitabine/tenofovir, tell your||
0399|151|P|doctor or pharmacist if you are allergic to either of the||
0399|152|P|medications; or if you have any other allergies. This product may||
0399|153|P|contain inactive ingredients, which can cause allergic reactions||
0399|154|P|or other problems. Talk to your pharmacist for more details.||
0399|155|P|   Before using this medication, tell your doctor or pharmacist||
0399|156|P|your medical history, especially of: pancreatitis, liver problems||
0399|157|P|(hepatitis B, hepatitis C, cirrhosis), alcohol use, bone problems||
0399|158|P|(such as bone disease, bone loss/osteoporosis, weak/broken||
0399|159|P|bones), kidney disease.||
0399|160|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0399|161|P|can make you more dizzy. Do not drive, use machinery, or do||
0399|162|P|anything that needs alertness until you can do it safely. Limit||
0399|163|P|alcoholic beverages. Talk to your doctor if you are using||
0399|164|P|marijuana (cannabis).||
0399|165|P|   Before having surgery, tell your doctor or dentist about all||
0399|166|P|the products you use (including prescription drugs,||
0399|167|P|nonprescription drugs, and herbal products).||
0399|168|P|   During pregnancy, this medication should be used only when||
0399|169|P|clearly needed. Discuss the risks and benefits with your doctor.||
0399|170|P|If you have HIV infection, treatment can lower the risk of||
0399|171|P|passing HIV infection to your baby, and this medication may be||
0399|172|P|part of that treatment.||
0399|173|P|   This medication passes into breast milk, but is unlikely to||
0399|174|P|harm a nursing infant. If you have HIV, breast milk may transmit||
0399|175|P|HIV. Consult your doctor before breastfeeding.||
0399|176|B|||
0399|177|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0399|178|I|medications work or increase your risk for serious side effects.||
0399|179|I|This document does not contain all possible drug interactions.||
0399|180|I|Keep a list of all the products you use (including||
0399|181|I|prescription/nonprescription drugs and herbal products) and share||
0399|182|I|it with your doctor and pharmacist. Do not start, stop, or change||
0399|183|I|the dosage of any medicines without your doctor's approval.||
0399|184|I|   Some products that may interact with this drug include:||
0399|185|I|adefovir, orlistat, other drugs that may harm the kidneys||
0399|186|I|(including aminoglycosides such as amikacin/gentamicin).||
0399|187|I|   Tenofovir can decrease the effectiveness of another||
0399|188|I|medication, atazanavir (by decreasing blood levels). If you are||
0399|189|I|taking atazanavir with this product, you may need to also take||
0399|190|I|another medication (ritonavir). Consult your doctor or pharmacist||
0399|191|I|for more details.||
0399|192|I|   Check the labels on all your medicines for HIV infection||
0399|193|I|because they may contain the same or similar ingredients as those||
0399|194|I|in this product (such as tenofovir, emtricitabine, lamivudine).||
0399|195|I|Do not take medications that contain the same or similar||
0399|196|I|ingredients as this product.||
0399|197|B|||
0399|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0399|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0399|200|O|poison control center right away. US residents can call||
0399|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0399|202|B|||
0399|203|N|NOTES:  Do not share this medication with others.||
0399|204|N|   Lab and/or medical tests (such as kidney tests, urine||
0399|205|N|glucose/protein, liver tests, viral load, T-cell counts, blood||
0399|206|N|mineral levels, bone density tests, test for hepatitis B virus)||
0399|207|N|should be done before you start taking this medication and while||
0399|208|N|you are taking it. Keep all medical and lab appointments. Consult||
0399|209|N|your doctor for more details.||
0399|210|B|||
0399|211|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0399|212|D|remember. If it is near the time of the next dose, skip the||
0399|213|D|missed dose. Take your next dose at the regular time. Do not||
0399|214|D|double the dose to catch up.||
0399|215|B|||
0399|216|R|STORAGE:  Store in the original container at room temperature||
0399|217|R|away from light and moisture. Do not store in the bathroom. Keep||
0399|218|R|all medications away from children and pets.||
0399|219|R|   Do not flush medications down the toilet or pour them into a||
0399|220|R|drain unless instructed to do so. Properly discard this product||
0399|221|R|when it is expired or no longer needed. Consult your pharmacist||
0399|222|R|or local waste disposal company.||
0399|223|B|||
0399|224|A|Information last revised April 2025.||
0399|225|A|Copyright(c) 2025 First Databank, Inc.||
0399|226|B|||
0401|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0401|002|Z|does NOT have all possible information about this product. This||
0401|003|Z|information does not assure that this product is safe, effective,||
0401|004|Z|or appropriate for you. This information is not individual||
0401|005|Z|medical advice and does not substitute for the advice of your||
0401|006|Z|health care professional. Always ask your health care||
0401|007|Z|professional for complete information about this product and your||
0401|008|Z|specific health needs.||
0401|009|B|||
0401|010|T|ACAMPROSATE CALCIUM DELAYED-RELEASE - ORAL||
0401|011|F|(a-KAM-proe-sate KAL-see-um)||
0401|012|B|||
0401|013|C|COMMON BRAND NAME(S): Campral||
0401|014|B|||
0401|015|U|USES:  This medication is used along with counseling and support||
0401|016|U|to help people who are alcohol dependent not drink alcohol.||
0401|017|U|Acamprosate works by restoring the natural balance of chemicals||
0401|018|U|in the brain (neurotransmitters).||
0401|019|U|   Before starting this medication, you should no longer be||
0401|020|U|drinking alcohol. Acamprosate has not been shown to work well if||
0401|021|U|you are still drinking alcohol when you start taking it.||
0401|022|B|||
0401|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0401|024|H|from your pharmacist before you start taking acamprosate and each||
0401|025|H|time you get a refill. If you have any questions, ask your doctor||
0401|026|H|or pharmacist.||
0401|027|H|   Take this medication by mouth with or without food as directed||
0401|028|H|by your doctor, usually three times a day. Swallow the tablets||
0401|029|H|whole. Do not crush or chew the tablets.||
0401|030|H|   The dosage is based on your medical condition and response to||
0401|031|H|treatment.||
0401|032|H|   Use this medication regularly to get the most benefit from it.||
0401|033|H|To help you remember, take it at the same times each day.||
0401|034|H|   Do not increase your dose or use this drug more often or for||
0401|035|H|longer than prescribed. Your condition will not improve any||
0401|036|H|faster, and your risk of side effects will increase.||
0401|037|H|   If you begin drinking alcohol again, continue to take this||
0401|038|H|medication and tell your doctor promptly.||
0401|039|B|||
0401|040|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, gas, stomach pain,||
0401|041|S|loss of appetite, headache, drowsiness, dizziness, constipation,||
0401|042|S|tiredness, weight gain/loss, muscle/joint pain, change in sexual||
0401|043|S|desire or decreased sexual ability may occur. If any of these||
0401|044|S|effects last or get worse, tell your doctor or pharmacist||
0401|045|S|promptly.||
0401|046|S|   Remember that this medication has been prescribed because your||
0401|047|S|doctor has judged that the benefit to you is greater than the||
0401|048|S|risk of side effects. Many people using this medication do not||
0401|049|S|have serious side effects.||
0401|050|S|   Tell your doctor right away if you have any serious side||
0401|051|S|effects, including: mental/mood changes (including depression,||
0401|052|S|thoughts of suicide), signs of kidney problems (such as change in||
0401|053|S|the amount of urine), fainting, fast/pounding heartbeat,||
0401|054|S|vision/hearing changes, increased thirst.||
0401|055|S|   Get medical help right away if you have any very serious side||
0401|056|S|effects, including: stomach/abdominal pain that doesn't go away,||
0401|057|S|black stools, vomit that looks like coffee grounds, seizures.||
0401|058|S|   A very serious allergic reaction to this drug is rare.||
0401|059|S|However, get medical help right away if you notice any symptoms||
0401|060|S|of a serious allergic reaction, including: rash, itching/swelling||
0401|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0401|062|S|breathing.||
0401|063|S|   This is not a complete list of possible side effects. If you||
0401|064|S|notice other effects not listed above, contact your doctor or||
0401|065|S|pharmacist.||
0401|066|S|   In the US -||
0401|067|S|   Call your doctor for medical advice about side effects. You||
0401|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0401|069|S|www.fda.gov/medwatch.||
0401|070|S|   In Canada - Call your doctor for medical advice about side||
0401|071|S|effects. You may report side effects to Health Canada at||
0401|072|S|1-866-234-2345.||
0401|073|B|||
0401|074|P|PRECAUTIONS:  Before taking acamprosate, tell your doctor or||
0401|075|P|pharmacist if you are allergic to it or if you have any other||
0401|076|P|allergies. This product may contain inactive ingredients, which||
0401|077|P|can cause allergic reactions or other problems. Talk to your||
0401|078|P|pharmacist for more details.||
0401|079|P|   Before using this medication, tell your doctor or pharmacist||
0401|080|P|your medical history, especially of: kidney disease.||
0401|081|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0401|082|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0401|083|P|machinery, or do anything that needs alertness until you can do||
0401|084|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0401|085|P|are using marijuana (cannabis).||
0401|086|P|   Before having surgery, tell your doctor or dentist about all||
0401|087|P|the products you use (including prescription drugs,||
0401|088|P|nonprescription drugs, and herbal products).||
0401|089|P|   During pregnancy, this medication should be used only when||
0401|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
0401|091|P|   It is unknown if this medication passes into breast milk.||
0401|092|P|Consult your doctor before breastfeeding.||
0401|093|B|||
0401|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0401|095|I|medications work or increase your risk for serious side effects.||
0401|096|I|This document does not contain all possible drug interactions.||
0401|097|I|Keep a list of all the products you use (including||
0401|098|I|prescription/nonprescription drugs and herbal products) and share||
0401|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
0401|100|I|the dosage of any medicines without your doctor's approval.||
0401|101|B|||
0401|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0401|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0401|104|O|poison control center right away. US residents can call||
0401|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0401|106|O|Symptoms of overdose may include: severe diarrhea that doesn't||
0401|107|O|stop.||
0401|108|B|||
0401|109|N|NOTES:  Do not share this medication with others.||
0401|110|N|   Lab tests (such as kidney function) should be done while you||
0401|111|N|are taking this medication. Keep all medical and lab||
0401|112|N|appointments. Go to all of your counseling and support group||
0401|113|N|meetings. Consult your doctor for more details.||
0401|114|B|||
0401|115|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0401|116|D|remember. If it is near the time of the next dose, skip the||
0401|117|D|missed dose. Take your next dose at the regular time. Do not||
0401|118|D|double the dose to catch up.||
0401|119|B|||
0401|120|R|STORAGE:  Store at room temperature away from light and moisture.||
0401|121|R|Do not store in the bathroom. Keep all medications away from||
0401|122|R|children and pets.||
0401|123|R|   Do not flush medications down the toilet or pour them into a||
0401|124|R|drain unless instructed to do so. Properly discard this product||
0401|125|R|when it is expired or no longer needed. Consult your pharmacist||
0401|126|R|or local waste disposal company.||
0401|127|B|||
0401|128|A|Information last revised May 2024.||
0401|129|A|Copyright(c) 2025 First Databank, Inc.||
0401|130|B|||
0402|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0402|002|Z|does NOT have all possible information about this product. This||
0402|003|Z|information does not assure that this product is safe, effective,||
0402|004|Z|or appropriate for you. This information is not individual||
0402|005|Z|medical advice and does not substitute for the advice of your||
0402|006|Z|health care professional. Always ask your health care||
0402|007|Z|professional for complete information about this product and your||
0402|008|Z|specific health needs.||
0402|009|B|||
0402|010|T|ABACAVIR/LAMIVUDINE - ORAL||
0402|011|F|(a-BAK-a-vir/la-MIV-ue-deen)||
0402|012|B|||
0402|013|C|COMMON BRAND NAME(S): Epzicom||
0402|014|B|||
0402|015|W|WARNING:  In some patients, the abacavir in this product has||
0402|016|W|caused a serious (sometimes fatal) allergic reaction. Your doctor||
0402|017|W|should order a blood test to measure your risk before you start||
0402|018|W|this medication or take it again. If the blood test shows you are||
0402|019|W|at greater risk, you should not take this medication and your||
0402|020|W|doctor should discuss other treatment choices with you. Symptoms||
0402|021|W|of an allergic reaction may include any of the following: rash,||
0402|022|W|itching/swelling (especially of the face/tongue/throat), severe||
0402|023|W|dizziness, trouble breathing, fever, extreme tiredness, nausea,||
0402|024|W|vomiting, diarrhea, stomach pain, muscle aches, sore throat,||
0402|025|W|mouth sores, or cough. Get medical help right away if you||
0402|026|W|experience any of these symptoms. If you have stopped taking||
0402|027|W|abacavir because of an allergic reaction, you must never take any||
0402|028|W|form of abacavir again, or death could result. Tell all of your||
0402|029|W|doctors and pharmacists if you have stopped taking abacavir due||
0402|030|W|to an allergic reaction. Also, properly throw away any unused||
0402|031|W|medications containing abacavir. Read the warning card provided||
0402|032|W|with this medication for more details.||
0402|033|W|   If you have hepatitis B infection and HIV, you may have a||
0402|034|W|serious worsening of hepatitis symptoms if you stop taking||
0402|035|W|lamivudine. Talk with your doctor before stopping this||
0402|036|W|medication. Your doctor will monitor liver tests for several||
0402|037|W|months after you stop lamivudine. Get medical help right away if||
0402|038|W|you develop symptoms of worsening liver problems.||
0402|039|B|||
0402|040|U|USES:  This product contains 2 drugs: abacavir and lamivudine. It||
0402|041|U|is used with other HIV medications to help control HIV infection.||
0402|042|U|It helps to decrease the amount of HIV in your body so your||
0402|043|U|immune system can work better. This lowers your chance of getting||
0402|044|U|HIV complications (such as new infections, cancer) and improves||
0402|045|U|your quality of life. Abacavir and lamivudine both belong to a||
0402|046|U|class of drugs known as nucleoside reverse transcriptase||
0402|047|U|inhibitors (NRTIs).||
0402|048|U|   Abacavir/lamivudine is not a cure for HIV infection. To||
0402|049|U|decrease your risk of spreading HIV disease to others, continue||
0402|050|U|to take all HIV medications exactly as prescribed by your doctor.||
0402|051|U|Use an effective barrier method (latex or polyurethane||
0402|052|U|condoms/dental dams) during sexual activity as directed by your||
0402|053|U|doctor. Do not share personal items (such as needles/syringes,||
0402|054|U|toothbrushes, and razors) that may have contacted blood or other||
0402|055|U|body fluids. Consult your doctor or pharmacist for more details.||
0402|056|B|||
0402|057|H|HOW TO USE:  Read the Medication Guide and Warning Card provided||
0402|058|H|by your pharmacist before you start taking abacavir/lamivudine||
0402|059|H|and each time you get a refill. Carry the Warning Card with you||
0402|060|H|at all times. If you have any questions, ask your doctor or||
0402|061|H|pharmacist.||
0402|062|H|   Take this medication by mouth with or without food as directed||
0402|063|H|by your doctor, usually once daily.||
0402|064|H|   Because this combination product has fixed doses of abacavir||
0402|065|H|and lamivudine, it should only be used if your doctor has||
0402|066|H|determined that the doses of both medications in this product are||
0402|067|H|right for you.||
0402|068|H|   If you stop taking any medication containing abacavir even for||
0402|069|H|a short time and then restart the drug, you have an increased||
0402|070|H|chance of developing a very serious (possibly fatal) allergic||
0402|071|H|reaction. Refill your medication before you run out. Do not stop||
0402|072|H|treatment unless directed by your doctor. Before restarting any||
0402|073|H|medication containing abacavir, consult your doctor or||
0402|074|H|pharmacist, and be sure you have easy access to medical care.||
0402|075|H|   It is very important to keep taking this medication (and other||
0402|076|H|HIV medications) exactly as prescribed by your doctor. Do not||
0402|077|H|skip any doses. Do not increase your dose, take this drug more||
0402|078|H|often than prescribed, or stop taking it (or other HIV medicines)||
0402|079|H|even for a short time unless directed to do so by your doctor.||
0402|080|H|Skipping or changing your dose without approval from your doctor||
0402|081|H|may cause the amount of virus to increase, make the infection||
0402|082|H|more difficult to treat (resistant), or worsen side effects.||
0402|083|H|   For the best effect, take this medication at evenly spaced||
0402|084|H|times. To help you remember, take this medication at the same||
0402|085|H|time every day.||
0402|086|B|||
0402|087|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
0402|088|S|   Headache, nausea, diarrhea, dizziness, tiredness, or trouble||
0402|089|S|sleeping may occur. If any of these effects last or get worse,||
0402|090|S|tell your doctor or pharmacist promptly.||
0402|091|S|   Remember that this medication has been prescribed because your||
0402|092|S|doctor has judged that the benefit to you is greater than the||
0402|093|S|risk of side effects. Many people using this medication do not||
0402|094|S|have serious side effects.||
0402|095|S|   As your immune system gets stronger, it can begin to fight off||
0402|096|S|infections you already had, possibly causing disease symptoms to||
0402|097|S|come back. You could also have symptoms if your immune system||
0402|098|S|becomes overactive. This reaction may happen at any time (soon||
0402|099|S|after starting HIV treatment or many months later). Tell your||
0402|100|S|doctor right away if you have any serious symptoms, including:||
0402|101|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
0402|102|S|that doesn't go away, headaches that are severe or don't go away,||
0402|103|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
0402|104|S|changes, signs of infection (such as sore throat that doesn't go||
0402|105|S|away, fever, chills, swollen lymph nodes, non-healing skin||
0402|106|S|sores), signs of an overactive thyroid (such as irritability,||
0402|107|S|nervousness, heat intolerance, fast/pounding/irregular||
0402|108|S|heartbeat).||
0402|109|S|   Tell your doctor right away if you have any serious side||
0402|110|S|effects, including: mental/mood changes (such as depression,||
0402|111|S|anxiety), easy bruising/bleeding, signs of anemia (such as||
0402|112|S|unusual tiredness, fast breathing, pale skin, fast heartbeat).||
0402|113|S|   Get medical help right away if you have any very serious side||
0402|114|S|effects, including: signs of pancreatitis (such as nausea,||
0402|115|S|vomiting, stomach/abdominal/back pain, fever).||
0402|116|S|   Rarely, this medication has caused severe (sometimes fatal)||
0402|117|S|liver problems and a buildup of lactic acid in the blood (lactic||
0402|118|S|acidosis). These serious side effects may occur more often in||
0402|119|S|women and obese patients. Get medical help right away if you have||
0402|120|S|any of the following serious symptoms, including: symptoms of||
0402|121|S|liver problems (such as nausea/vomiting that doesn't stop, loss||
0402|122|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0402|123|S|urine), symptoms of lactic acidosis (such as deep/rapid||
0402|124|S|breathing, drowsiness, nausea/vomiting).||
0402|125|S|   This is not a complete list of possible side effects. If you||
0402|126|S|notice other effects not listed above, contact your doctor or||
0402|127|S|pharmacist.||
0402|128|S|   In the US -||
0402|129|S|   Call your doctor for medical advice about side effects. You||
0402|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0402|131|S|www.fda.gov/medwatch.||
0402|132|S|   In Canada - Call your doctor for medical advice about side||
0402|133|S|effects. You may report side effects to Health Canada at||
0402|134|S|1-866-234-2345.||
0402|135|B|||
0402|136|P|PRECAUTIONS:  Before taking abacavir/lamivudine, tell your doctor||
0402|137|P|or pharmacist if you are allergic to either of these drugs; or if||
0402|138|P|you have any other allergies. This product may contain inactive||
0402|139|P|ingredients, which can cause allergic reactions or other||
0402|140|P|problems. Talk to your pharmacist for more details.||
0402|141|P|   Before using this medication, tell your doctor or pharmacist||
0402|142|P|your medical history, especially of: kidney problems, liver||
0402|143|P|problems (such as hepatitis B or C, cirrhosis), disease of the||
0402|144|P|pancreas (pancreatitis), alcohol use.||
0402|145|P|   Abacavir may increase your risk of a heart attack. Discuss the||
0402|146|P|risks and benefits of treatment with your doctor and ways to||
0402|147|P|lower your risk of heart disease. Tell your doctor if you have||
0402|148|P|heart problems, if you smoke, or if you have other conditions||
0402|149|P|that increase your risk of heart disease, such as high blood||
0402|150|P|pressure, diabetes, or high cholesterol levels.||
0402|151|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0402|152|P|can make you more dizzy. Do not drive, use machinery, or do||
0402|153|P|anything that needs alertness until you can do it safely. Limit||
0402|154|P|alcoholic beverages. Alcohol may also increase the risk of liver||
0402|155|P|problems and pancreatitis. Talk to your doctor if you are using||
0402|156|P|marijuana (cannabis).||
0402|157|P|   Before having surgery, tell your doctor or dentist about all||
0402|158|P|the products you use (including prescription drugs,||
0402|159|P|nonprescription drugs, and herbal products).||
0402|160|P|   Children may be more sensitive to the side effects of this||
0402|161|P|drug, especially pancreatitis.||
0402|162|P|   Tell your doctor if you are pregnant before using this||
0402|163|P|medication. Treatment can lower the risk of passing HIV infection||
0402|164|P|to your baby. Discuss the risks and benefits with your doctor.||
0402|165|P|   This medication passes into breast milk. Because breast milk||
0402|166|P|may transmit HIV, consult your doctor before breastfeeding.||
0402|167|B|||
0402|168|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0402|169|I|medications work or increase your risk for serious side effects.||
0402|170|I|This document does not contain all possible drug interactions.||
0402|171|I|Keep a list of all the products you use (including||
0402|172|I|prescription/nonprescription drugs and herbal products) and share||
0402|173|I|it with your doctor and pharmacist. Do not start, stop, or change||
0402|174|I|the dosage of any medicines without your doctor's approval.||
0402|175|I|   Do not take other products that contain abacavir or lamivudine||
0402|176|I|with this medication.||
0402|177|I|   Emtricitabine is similar to lamivudine and should not be taken||
0402|178|I|with this medication.||
0402|179|I|   Some products that may interact with this drug are: orlistat,||
0402|180|I|sorbitol.||
0402|181|B|||
0402|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0402|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0402|184|O|poison control center right away. US residents can call||
0402|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0402|186|B|||
0402|187|N|NOTES:  Do not share this medication with others.||
0402|188|N|   Lab and/or medical tests (such as blood tests, liver/kidney||
0402|189|N|function, viral load, T-cell counts) should be done while you are||
0402|190|N|taking this medication. Keep all medical and lab appointments.||
0402|191|N|Consult your doctor for more details||
0402|192|B|||
0402|193|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0402|194|D|remember. If it is near the time of the next dose, skip the||
0402|195|D|missed dose. Take your next dose at the regular time. Do not||
0402|196|D|double the dose to catch up.||
0402|197|B|||
0402|198|R|STORAGE:  Store at room temperature away from light and moisture.||
0402|199|R|Do not store in the bathroom. Keep all medications away from||
0402|200|R|children and pets.||
0402|201|R|   Do not flush medications down the toilet or pour them into a||
0402|202|R|drain unless instructed to do so. Properly discard this product||
0402|203|R|when it is expired or no longer needed. Consult your pharmacist||
0402|204|R|or local waste disposal company.||
0402|205|B|||
0402|206|A|Information last revised April 2025.||
0402|207|A|Copyright(c) 2025 First Databank, Inc.||
0402|208|B|||
0403|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0403|002|Z|does NOT have all possible information about this product. This||
0403|003|Z|information does not assure that this product is safe, effective,||
0403|004|Z|or appropriate for you. This information is not individual||
0403|005|Z|medical advice and does not substitute for the advice of your||
0403|006|Z|health care professional. Always ask your health care||
0403|007|Z|professional for complete information about this product and your||
0403|008|Z|specific health needs.||
0403|009|B|||
0403|010|T|TROSPIUM - ORAL||
0403|011|F|(TROSE-pee-um)||
0403|012|B|||
0403|013|C|COMMON BRAND NAME(S): Sanctura||
0403|014|B|||
0403|015|U|USES:  This medication is used to treat an overactive bladder. By||
0403|016|U|relaxing the muscles in the bladder, trospium improves your||
0403|017|U|ability to control your urination. It helps to reduce leaking of||
0403|018|U|urine, feelings of needing to urinate right away, and frequent||
0403|019|U|trips to the bathroom. Trospium belongs to a class of drugs known||
0403|020|U|as antispasmodics. It is also known as an antimuscarinic.||
0403|021|B|||
0403|022|H|HOW TO USE:  Take this medication by mouth on an empty stomach||
0403|023|H|(at least 1 hour before a meal) as directed by your doctor,||
0403|024|H|usually twice daily. The dosage is based on your age, medical||
0403|025|H|condition, and response to treatment.||
0403|026|H|   Use this medication regularly in order to get the most benefit||
0403|027|H|from it. Remember to use it at the same time(s) each day.||
0403|028|H|   Tell your doctor if your condition does not get better or if||
0403|029|H|it gets worse.||
0403|030|B|||
0403|031|S|SIDE EFFECTS:  Dry mouth, constipation, stomach upset, headache,||
0403|032|S|dry eyes, dizziness, blurred vision, or drowsiness may occur. If||
0403|033|S|any of these effects last or get worse, tell your doctor or||
0403|034|S|pharmacist promptly.||
0403|035|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0403|036|S|chips, chew (sugarless) gum, drink water or use a saliva||
0403|037|S|substitute.||
0403|038|S|   Remember that this medication has been prescribed because your||
0403|039|S|doctor has judged that the benefit to you is greater than the||
0403|040|S|risk of side effects. Many people using this medication do not||
0403|041|S|have serious side effects.||
0403|042|S|   Tell your doctor right away if you have any serious side||
0403|043|S|effects, including: eye pain, difficulty urinating, fast||
0403|044|S|heartbeat, mental/mood changes (such as hallucinations,||
0403|045|S|confusion).||
0403|046|S|   A very serious allergic reaction to this drug is rare.||
0403|047|S|However, get medical help right away if you notice any symptoms||
0403|048|S|of a serious allergic reaction, including: rash, itching/swelling||
0403|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0403|050|S|breathing.||
0403|051|S|   This is not a complete list of possible side effects. If you||
0403|052|S|notice other effects not listed above, contact your doctor or||
0403|053|S|pharmacist.||
0403|054|S|   In the US -||
0403|055|S|   Call your doctor for medical advice about side effects. You||
0403|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0403|057|S|www.fda.gov/medwatch.||
0403|058|S|   In Canada - Call your doctor for medical advice about side||
0403|059|S|effects. You may report side effects to Health Canada at||
0403|060|S|1-866-234-2345.||
0403|061|B|||
0403|062|P|PRECAUTIONS:  Before taking trospium, tell your doctor or||
0403|063|P|pharmacist if you are allergic to it; or if you have any other||
0403|064|P|allergies. This product may contain inactive ingredients, which||
0403|065|P|can cause allergic reactions or other problems. Talk to your||
0403|066|P|pharmacist for more details.||
0403|067|P|   Before using this medication, tell your doctor or pharmacist||
0403|068|P|your medical history, especially of: glaucoma, kidney disease,||
0403|069|P|liver disease, stomach/intestinal problems (such as blockage,||
0403|070|P|constipation, ulcerative colitis), myasthenia gravis, inability||
0403|071|P|to urinate (urinary retention).||
0403|072|P|   This drug may make you dizzy or drowsy or blur your vision.||
0403|073|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0403|074|P|drowsy. Do not drive, use machinery, or do anything that needs||
0403|075|P|alertness or clear vision until you can do it safely. Limit||
0403|076|P|alcoholic beverages. Talk to your doctor if you are using||
0403|077|P|marijuana (cannabis).||
0403|078|P|   This medication may make you sweat less, making you more||
0403|079|P|likely to get heat stroke. Avoid doing things that may cause you||
0403|080|P|to overheat, such as hard work or exercise in hot weather, or||
0403|081|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0403|082|P|and dress lightly. If you overheat, quickly look for a place to||
0403|083|P|cool down and rest. Get medical help right away if you have a||
0403|084|P|fever that does not go away, mental/mood changes, headache, or||
0403|085|P|dizziness.||
0403|086|P|   Older adults may be more sensitive to the side effects of this||
0403|087|P|drug, especially constipation, dry mouth, drowsiness, confusion,||
0403|088|P|or trouble urinating. Drowsiness and confusion can increase the||
0403|089|P|risk of falling.||
0403|090|P|   During pregnancy, this medication should be used only when||
0403|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
0403|092|P|   It is unknown if this drug passes into breast milk. Consult||
0403|093|P|your doctor before breastfeeding.||
0403|094|B|||
0403|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0403|096|I|medications work or increase your risk for serious side effects.||
0403|097|I|This document does not contain all possible drug interactions.||
0403|098|I|Keep a list of all the products you use (including||
0403|099|I|prescription/nonprescription drugs and herbal products) and share||
0403|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
0403|101|I|the dosage of any medicines without your doctor's approval.||
0403|102|I|   Some products that may interact with this drug are: potassium||
0403|103|I|tablets/capsules, pramlintide.||
0403|104|I|   Tell your doctor or pharmacist if you are taking other||
0403|105|I|products that cause drowsiness, including alcohol, marijuana||
0403|106|I|(cannabis), certain antihistamines (such as cetirizine,||
0403|107|I|diphenhydramine), drugs for sleep or anxiety (such as alprazolam,||
0403|108|I|diazepam, zolpidem), muscle relaxants, and opioid pain relievers||
0403|109|I|(such as codeine).||
0403|110|I|   Check the labels on all your medicines (such as allergy or||
0403|111|I|cough-and-cold products) because they may contain ingredients||
0403|112|I|that cause drowsiness. Ask your pharmacist about using those||
0403|113|I|products safely.||
0403|114|B|||
0403|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0403|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0403|117|O|poison control center right away. US residents can call||
0403|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0403|119|O|Symptoms of overdose may include: fast heartbeat, widened pupils.||
0403|120|B|||
0403|121|N|NOTES:  Do not share this medication with others.||
0403|122|B|||
0403|123|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0403|124|D|remember. Take the missed dose at least 2 hours after a meal or 1||
0403|125|D|hour before your next meal. If it is near the time of your next||
0403|126|D|dose, skip the missed dose. Take your next dose at the regular||
0403|127|D|time. Do not double the dose to catch up.||
0403|128|B|||
0403|129|R|STORAGE:  Store at room temperature away from light and moisture.||
0403|130|R|Do not store in the bathroom. Keep all medications away from||
0403|131|R|children and pets.||
0403|132|R|   Do not flush medications down the toilet or pour them into a||
0403|133|R|drain unless instructed to do so. Properly discard this product||
0403|134|R|when it is expired or no longer needed. Consult your pharmacist||
0403|135|R|or local waste disposal company.||
0403|136|B|||
0403|137|A|Information last revised October 2024.||
0403|138|A|Copyright(c) 2025 First Databank, Inc.||
0403|139|B|||
0404|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0404|002|Z|does NOT have all possible information about this product. This||
0404|003|Z|information does not assure that this product is safe, effective,||
0404|004|Z|or appropriate for you. This information is not individual||
0404|005|Z|medical advice and does not substitute for the advice of your||
0404|006|Z|health care professional. Always ask your health care||
0404|007|Z|professional for complete information about this product and your||
0404|008|Z|specific health needs.||
0404|009|B|||
0404|010|T|DULOXETINE - ORAL||
0404|011|F|(doo-LOX-e-teen)||
0404|012|B|||
0404|013|C|COMMON BRAND NAME(S): Cymbalta||
0404|014|B|||
0404|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0404|016|W|of conditions, including depression and other mental/mood||
0404|017|W|disorders. These medications can help prevent suicidal||
0404|018|W|thoughts/attempts and provide other important benefits. However,||
0404|019|W|a small number of people (especially people younger than 25) who||
0404|020|W|take antidepressants for any condition may experience worsening||
0404|021|W|depression, other mental/mood symptoms, or suicidal||
0404|022|W|thoughts/attempts. It is very important to talk with the doctor||
0404|023|W|about the risks and benefits of antidepressant medication||
0404|024|W|(especially for people younger than 25), even if treatment is not||
0404|025|W|for a mental/mood condition.||
0404|026|W|   Tell the doctor right away if you notice worsening||
0404|027|W|depression/other psychiatric conditions, unusual behavior changes||
0404|028|W|(including possible suicidal thoughts/attempts), or other||
0404|029|W|mental/mood changes (including new/worsening anxiety, panic||
0404|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0404|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0404|032|W|especially watchful for these symptoms when a new antidepressant||
0404|033|W|is started or when the dose is changed.||
0404|034|B|||
0404|035|U|USES:  This medication is used to treat certain mental/mood||
0404|036|U|disorders (such as depression, anxiety). It is also used to help||
0404|037|U|relieve nerve pain (peripheral neuropathy) in people with||
0404|038|U|diabetes or ongoing pain due to medical conditions such as||
0404|039|U|arthritis, chronic back pain, or fibromyalgia (a condition that||
0404|040|U|causes widespread pain). Duloxetine belongs to a class of drugs||
0404|041|U|known as serotonin-norepinephrine reuptake inhibitors (SNRIs). It||
0404|042|U|works by helping to restore the balance of certain natural||
0404|043|U|substances (serotonin and norepinephrine) in the brain.||
0404|044|B|||
0404|045|V|OTHER USES:  This section contains uses of this drug that are not||
0404|046|V|listed in the approved professional labeling for the drug but||
0404|047|V|that may be prescribed by your health care professional. Use this||
0404|048|V|drug for a condition that is listed in this section only if it||
0404|049|V|has been so prescribed by your health care professional.||
0404|050|V|   This drug may also be used for other painful nerve conditions||
0404|051|V|(neuropathic pain) or binge eating disorder (BED).||
0404|052|B|||
0404|053|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0404|054|H|Patient Information Leaflet provided by your pharmacist before||
0404|055|H|you start using duloxetine and each time you get a refill. If you||
0404|056|H|have any questions, ask your doctor or pharmacist.||
0404|057|H|   Take this medication by mouth as directed by your doctor,||
0404|058|H|usually 1 or 2 times a day with or without food. If you have||
0404|059|H|nausea, it may help to take this drug with food. Swallow the||
0404|060|H|capsule whole. Do not crush or chew the capsule or mix the||
0404|061|H|contents with food or liquid. Doing so can release all of the||
0404|062|H|drug at once, increasing the risk of side effects.||
0404|063|H|   The dosage is based on your age, medical condition and||
0404|064|H|response to treatment. To reduce your risk of side effects, your||
0404|065|H|doctor may direct you to start this medication at a low dose and||
0404|066|H|gradually increase your dose. Follow your doctor's instructions||
0404|067|H|carefully. Take this medication regularly to get the most benefit||
0404|068|H|from it. To help you remember, take it at the same time(s) each||
0404|069|H|day.||
0404|070|H|   Keep taking this medication even if you feel well. Do not stop||
0404|071|H|taking this medication without consulting your doctor. Some||
0404|072|H|conditions may become worse when this drug is suddenly stopped.||
0404|073|H|Also, you may experience symptoms such as dizziness, confusion,||
0404|074|H|mood swings, headache, tiredness, diarrhea, sleep changes, and||
0404|075|H|brief feelings similar to electric shock. Your dose may need to||
0404|076|H|be gradually decreased to reduce side effects. Report any new or||
0404|077|H|worsening symptoms right away.||
0404|078|H|   Tell your doctor if your condition lasts or gets worse.||
0404|079|B|||
0404|080|S|SIDE EFFECTS:  See also Warning section.||
0404|081|S|   Nausea, dry mouth, constipation, loss of appetite, tiredness,||
0404|082|S|drowsiness, or increased sweating may occur. If any of these||
0404|083|S|effects last or get worse, tell your doctor promptly.||
0404|084|S|   Dizziness or lightheadedness may occur, especially when you||
0404|085|S|first start or increase your dose of this drug. To reduce the||
0404|086|S|risk of dizziness, lightheadedness, or falling, get up slowly||
0404|087|S|when rising from a sitting or lying position.||
0404|088|S|   Remember that this medication has been prescribed because your||
0404|089|S|doctor has judged that the benefit to you is greater than the||
0404|090|S|risk of side effects. Many people using this medication do not||
0404|091|S|have serious side effects.||
0404|092|S|   This medication may raise your blood pressure. Check your||
0404|093|S|blood pressure regularly and tell your doctor if the results are||
0404|094|S|high.||
0404|095|S|   Tell your doctor right away if you have any serious side||
0404|096|S|effects, including: confusion, easy bleeding/bruising, decreased||
0404|097|S|interest in sex, changes in sexual ability, muscle||
0404|098|S|cramps/weakness, shaking (tremor), difficulty urinating, signs of||
0404|099|S|liver problems (such as nausea that doesn't stop,||
0404|100|S|stomach/abdominal pain, vomiting, yellowing eyes/skin, dark||
0404|101|S|urine).||
0404|102|S|   Get medical help right away if you have any very serious side||
0404|103|S|effects, including: black stools, vomit that looks like coffee||
0404|104|S|grounds, seizure, eye pain/swelling/redness, widened pupils,||
0404|105|S|vision changes (such as seeing rainbows around lights at night,||
0404|106|S|blurred vision).||
0404|107|S|   This medication may increase serotonin and rarely cause a very||
0404|108|S|serious condition called serotonin syndrome/toxicity. The risk||
0404|109|S|increases if you are also taking other drugs that increase||
0404|110|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0404|111|S|take (see Drug Interactions section). Get medical help right away||
0404|112|S|if you develop some of the following symptoms: fast heartbeat,||
0404|113|S|hallucinations, loss of coordination, severe dizziness, severe||
0404|114|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0404|115|S|unusual agitation/restlessness.||
0404|116|S|   A very serious allergic reaction to this drug is rare.||
0404|117|S|However, get medical help right away if you notice any symptoms||
0404|118|S|of a serious allergic reaction, including: rash, itching/swelling||
0404|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0404|120|S|breathing, skin blisters, mouth sores.||
0404|121|S|   This is not a complete list of possible side effects. If you||
0404|122|S|notice other effects not listed above, contact your doctor or||
0404|123|S|pharmacist.||
0404|124|S|   In the US -||
0404|125|S|   Call your doctor for medical advice about side effects. You||
0404|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0404|127|S|www.fda.gov/medwatch.||
0404|128|S|   In Canada - Call your doctor for medical advice about side||
0404|129|S|effects. You may report side effects to Health Canada at||
0404|130|S|1-866-234-2345.||
0404|131|B|||
0404|132|P|PRECAUTIONS:  Before taking duloxetine, tell your doctor or||
0404|133|P|pharmacist if you are allergic to it; or if you have any other||
0404|134|P|allergies. This product may contain inactive ingredients, which||
0404|135|P|can cause allergic reactions or other problems. Talk to your||
0404|136|P|pharmacist for more details.||
0404|137|P|   Before using this medication, tell your doctor or pharmacist||
0404|138|P|your medical history, especially of: personal or family history||
0404|139|P|of psychiatric disorders (such as bipolar/manic-depressive||
0404|140|P|disorder), personal or family history of suicide attempts,||
0404|141|P|bleeding problems, personal or family history of glaucoma||
0404|142|P|(angle-closure type), high blood pressure, kidney disease, liver||
0404|143|P|disease, seizure disorder, stomach problems (such as slow||
0404|144|P|emptying of the stomach), use/abuse of alcohol.||
0404|145|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0404|146|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0404|147|P|machinery, or do anything that needs alertness until you can do||
0404|148|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0404|149|P|are using marijuana (cannabis).||
0404|150|P|   If you have diabetes, duloxetine may affect your blood sugar.||
0404|151|P|Check your blood sugar regularly as directed and share the||
0404|152|P|results with your doctor. Your doctor may need to adjust your||
0404|153|P|diabetes medication, exercise program, or diet.||
0404|154|P|   Before having surgery, tell your doctor or dentist about all||
0404|155|P|the products you use (including prescription drugs,||
0404|156|P|nonprescription drugs, and herbal products).||
0404|157|P|   Older adults may be more sensitive to the side effects of this||
0404|158|P|drug, especially bleeding, dizziness, lightheadedness, or loss of||
0404|159|P|coordination. Older adults may also be more likely to develop a||
0404|160|P|type of salt imbalance (hyponatremia), especially if they are||
0404|161|P|taking "water pills" (diuretics). Dizziness, lightheadedness, or||
0404|162|P|loss of coordination can increase the risk of falling.||
0404|163|P|   Children may be more sensitive to the side effects of this||
0404|164|P|drug, especially loss of appetite and weight loss. Monitor weight||
0404|165|P|and height in children who are taking this drug. See also||
0404|166|P|Warning.||
0404|167|P|   During pregnancy, this medication should be used only when||
0404|168|P|clearly needed. This medication may harm an unborn baby. Babies||
0404|169|P|born to mothers who have used this drug during the last 3 months||
0404|170|P|of pregnancy may rarely develop withdrawal symptoms such as||
0404|171|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
0404|172|P|constant crying. If you notice any of these symptoms in your||
0404|173|P|newborn, tell the doctor promptly.||
0404|174|P|   Since untreated mental/mood problems (such as depression,||
0404|175|P|anxiety) can be a serious condition, do not stop taking this||
0404|176|P|medication unless directed by your doctor. If you are planning||
0404|177|P|pregnancy, become pregnant, or think you may be pregnant,||
0404|178|P|immediately discuss the benefits and risks of using this||
0404|179|P|medication during pregnancy with your doctor.||
0404|180|P|   This drug passes into breast milk and may have undesirable||
0404|181|P|effects on a nursing infant. Consult your doctor before||
0404|182|P|breastfeeding.||
0404|183|B|||
0404|184|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0404|185|I|medications work or increase your risk for serious side effects.||
0404|186|I|This document does not contain all possible drug interactions.||
0404|187|I|Keep a list of all the products you use (including||
0404|188|I|prescription/nonprescription drugs and herbal products) and share||
0404|189|I|it with your doctor and pharmacist. Do not start, stop, or change||
0404|190|I|the dosage of any medicines without your doctor's approval.||
0404|191|I|   Some products that may interact with this drug are: other||
0404|192|I|drugs that can cause bleeding/bruising (including antiplatelet||
0404|193|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
0404|194|I|"blood thinners" such as dabigatran/warfarin).||
0404|195|I|   Other medications can affect the removal of duloxetine from||
0404|196|I|your body, which may affect how duloxetine works. Examples||
0404|197|I|include cimetidine, viloxazine, certain quinolone antibiotics||
0404|198|I|(such as ciprofloxacin, enoxacin), among others.||
0404|199|I|   This medication can slow down the removal of other medications||
0404|200|I|from your body, which may affect how they work. Examples of||
0404|201|I|affected drugs include antiarrhythmic drugs (such as propafenone,||
0404|202|I|flecainide, quinidine), antipsychotics (such as thioridazine),||
0404|203|I|tricyclic antidepressants (such as desipramine, imipramine),||
0404|204|I|among others.||
0404|205|I|   Taking MAO inhibitors with this medication may cause a serious||
0404|206|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0404|207|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0404|208|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0404|209|I|selegiline, tranylcypromine) during treatment with this||
0404|210|I|medication. Most MAO inhibitors should also not be taken for two||
0404|211|I|weeks before and at least 5 days after treatment with this||
0404|212|I|medication. Ask your doctor when to start or stop taking this||
0404|213|I|medication.||
0404|214|I|   The risk of serotonin syndrome/toxicity increases if you are||
0404|215|I|also taking other drugs that increase serotonin. Examples include||
0404|216|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0404|217|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0404|218|I|other SNRIs such as desvenlafaxine/venlafaxine), tryptophan,||
0404|219|I|among others. The risk of serotonin syndrome/toxicity may be more||
0404|220|I|likely when you start or increase the dose of these drugs.||
0404|221|I|   Tell your doctor or pharmacist if you are taking other||
0404|222|I|products that cause drowsiness including alcohol, marijuana||
0404|223|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0404|224|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0404|225|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0404|226|I|codeine). Check the labels on all your medicines (such as allergy||
0404|227|I|or cough-and-cold products) because they may contain ingredients||
0404|228|I|that cause drowsiness. Ask your pharmacist about using those||
0404|229|I|products safely.||
0404|230|I|   Aspirin can increase the risk of bleeding when used with this||
0404|231|I|medication. However, if your doctor has told you to take low-dose||
0404|232|I|aspirin to prevent heart attack or stroke (usually 81-162||
0404|233|I|milligrams a day), you should keep taking the aspirin unless your||
0404|234|I|doctor tells you not to.||
0404|235|B|||
0404|236|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0404|237|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0404|238|O|poison control center right away. US residents can call||
0404|239|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0404|240|O|Symptoms of overdose may include: severe drowsiness, fainting.||
0404|241|B|||
0404|242|N|NOTES:  Do not share this medication with others.||
0404|243|N|   Lab and/or medical tests (such as blood pressure, liver||
0404|244|N|function) should be done while you are taking this medication.||
0404|245|N|Keep all medical and lab appointments. Consult your doctor for||
0404|246|N|more details||
0404|247|B|||
0404|248|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0404|249|D|remember. If it is near the time of the next dose, skip the||
0404|250|D|missed dose. Take your next dose at the regular time. Do not||
0404|251|D|double the dose to catch up.||
0404|252|B|||
0404|253|R|STORAGE:  Store at room temperature away from light and moisture.||
0404|254|R|Do not store in the bathroom. Keep all medications away from||
0404|255|R|children and pets.||
0404|256|R|   Do not flush medications down the toilet or pour them into a||
0404|257|R|drain unless instructed to do so. Properly discard this product||
0404|258|R|when it is expired or no longer needed. Consult your pharmacist||
0404|259|R|or local waste disposal company.||
0404|260|B|||
0404|261|A|Information last revised May 2024.||
0404|262|A|Copyright(c) 2025 First Databank, Inc.||
0404|263|B|||
0407|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0407|002|Z|does NOT have all possible information about this product. This||
0407|003|Z|information does not assure that this product is safe, effective,||
0407|004|Z|or appropriate for you. This information is not individual||
0407|005|Z|medical advice and does not substitute for the advice of your||
0407|006|Z|health care professional. Always ask your health care||
0407|007|Z|professional for complete information about this product and your||
0407|008|Z|specific health needs.||
0407|009|B|||
0407|010|T|CARBIDOPA/LEVODOPA DISINTEGRATING TABLET - ORAL||
0407|011|F|(KAR-bi-DOE-pa/LEE-voe-DOE-pa)||
0407|012|B|||
0407|013|C|COMMON BRAND NAME(S): Parcopa||
0407|014|B|||
0407|015|U|USES:  This combination medication is used to treat symptoms of||
0407|016|U|Parkinson's disease or Parkinson-like symptoms (such as||
0407|017|U|shakiness, stiffness, difficulty moving). Parkinson's disease is||
0407|018|U|thought to be caused by too little of a naturally occurring||
0407|019|U|substance (dopamine) in the brain. Levodopa changes into dopamine||
0407|020|U|in the brain, helping to control movement. Carbidopa prevents the||
0407|021|U|breakdown of levodopa in the bloodstream so more levodopa can||
0407|022|U|enter the brain. Carbidopa can also reduce some of levodopa's||
0407|023|U|side effects such as nausea and vomiting.||
0407|024|B|||
0407|025|H|HOW TO USE:  Take this medication by mouth with or without food||
0407|026|H|as directed by your doctor, usually 3 to 4 times a day. Gently||
0407|027|H|remove the tablet from the bottle with dry hands just before||
0407|028|H|taking a dose. Place the tablet on the tongue right away. It will||
0407|029|H|dissolve quickly and can be swallowed with your saliva. You do||
0407|030|H|not need water to take this medication.||
0407|031|H|   Taking this medication with food may help to decrease nausea.||
0407|032|H|It is best to avoid a high-protein diet (it decreases the amount||
0407|033|H|of levodopa that your body takes in) during treatment, unless||
0407|034|H|directed otherwise by your doctor. Separate your dose of this||
0407|035|H|medication by as many hours as possible from any iron supplements||
0407|036|H|or products containing iron (such as multivitamins with minerals)||
0407|037|H|you may take. Iron can reduce the amount of this medication||
0407|038|H|absorbed by the body. Consult your doctor or pharmacist for more||
0407|039|H|details.||
0407|040|H|   The dosage is based on your medical condition and response to||
0407|041|H|treatment. To reduce your risk of side effects, your doctor may||
0407|042|H|direct you to start this medication at a low dose and gradually||
0407|043|H|increase your dose. Follow your doctor's instructions carefully.||
0407|044|H|This combination medication comes in different strengths with||
0407|045|H|different amounts of carbidopa and levodopa in each tablet. Be||
0407|046|H|sure you have the correct strength of both drugs. Your doctor may||
0407|047|H|also prescribe carbidopa alone to be taken with this combination.||
0407|048|H|   Use this medication regularly to get the most benefit from it.||
0407|049|H|To help you remember, take it at the same times each day.||
0407|050|H|   Some patients may experience a "wearing-off" (worsening of||
0407|051|H|symptoms) before the next dose is due. An "on-off" effect might||
0407|052|H|also occur, in which sudden short periods of stiffness occur. If||
0407|053|H|these effects occur, contact your doctor for possible dose||
0407|054|H|adjustments that may help to lessen this effect.||
0407|055|H|   Do not stop taking this medication without consulting your||
0407|056|H|doctor. Some conditions may become worse when this medication is||
0407|057|H|suddenly stopped. Also, if you suddenly stop using this||
0407|058|H|medication, you may have withdrawal symptoms (such as anxiety,||
0407|059|H|depression, confusion, fever, muscle stiffness). To help prevent||
0407|060|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0407|061|H|more likely if you have used this medication for a long time or||
0407|062|H|in high doses. Tell your doctor or pharmacist right away if you||
0407|063|H|have withdrawal.||
0407|064|H|   Tell your doctor if your condition does not get better or if||
0407|065|H|it gets worse.||
0407|066|B|||
0407|067|S|SIDE EFFECTS:  Dizziness, lightheadedness, nausea, vomiting, loss||
0407|068|S|of appetite, trouble sleeping, unusual dreams, or headache may||
0407|069|S|occur. If any of these effects last or get worse, tell your||
0407|070|S|doctor or pharmacist promptly.||
0407|071|S|   This medication may cause saliva, urine, or sweat to turn a||
0407|072|S|dark color. This effect is harmless, but your clothes may be||
0407|073|S|stained.||
0407|074|S|   To reduce the risk of dizziness and lightheadedness, get up||
0407|075|S|slowly when rising from a sitting or lying position.||
0407|076|S|   Remember that this medication has been prescribed because your||
0407|077|S|doctor has judged that the benefit to you is greater than the||
0407|078|S|risk of side effects. Many people using this medication do not||
0407|079|S|have serious side effects.||
0407|080|S|   Some people taking this medication have fallen asleep suddenly||
0407|081|S|during their usual daily activities (such as talking on the||
0407|082|S|phone, driving). In some cases, sleep occurred without any||
0407|083|S|feelings of drowsiness beforehand. This sleep effect may occur||
0407|084|S|anytime during treatment with carbidopa/levodopa even if you have||
0407|085|S|used this medication for a long time. If you experience increased||
0407|086|S|sleepiness or fall asleep during the day, do not drive or do||
0407|087|S|other possibly dangerous activities until you have discussed this||
0407|088|S|effect with your doctor. Your risk of this sleep effect is||
0407|089|S|increased by using alcohol or other medications that can make you||
0407|090|S|drowsy. See also Precautions section.||
0407|091|S|   Tell your doctor right away if you have any serious side||
0407|092|S|effects, including: new/worsening movements you can't||
0407|093|S|control/spasms, greatly increased eye blinking/twitching, vision||
0407|094|S|changes (such as blurred vision, double vision), eye pain, severe||
0407|095|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
0407|096|S|coffee grounds, mental/mood changes (such as confusion,||
0407|097|S|agitation, hallucinations), signs of infection (such as sore||
0407|098|S|throat that doesn't go away, fever, chills), easy||
0407|099|S|bleeding/bruising, unusual tiredness, tingling of the hands/feet,||
0407|100|S|unusual strong urges (such as increased gambling, increased||
0407|101|S|sexual urges).||
0407|102|S|   Get medical help right away if you have any very serious side||
0407|103|S|effects, including: chest pain, fainting.||
0407|104|S|   Abruptly stopping or reducing the dose of this medication may||
0407|105|S|rarely cause a very serious condition called neuroleptic||
0407|106|S|malignant syndrome (NMS). Get medical help right away if you have||
0407|107|S|any of the following symptoms: fever, unusual muscle stiffness,||
0407|108|S|severe confusion, sweating, fast/irregular heartbeat.||
0407|109|S|   A very serious allergic reaction to this drug is rare.||
0407|110|S|However, get medical help right away if you notice any symptoms||
0407|111|S|of a serious allergic reaction, including: rash, itching/swelling||
0407|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0407|113|S|breathing.||
0407|114|S|   This is not a complete list of possible side effects. If you||
0407|115|S|notice other effects not listed above, contact your doctor or||
0407|116|S|pharmacist.||
0407|117|S|   In the US -||
0407|118|S|   Call your doctor for medical advice about side effects. You||
0407|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0407|120|S|www.fda.gov/medwatch.||
0407|121|S|   In Canada - Call your doctor for medical advice about side||
0407|122|S|effects. You may report side effects to Health Canada at||
0407|123|S|1-866-234-2345.||
0407|124|B|||
0407|125|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0407|126|P|pharmacist if you are allergic to carbidopa or levodopa; or to||
0407|127|P|foscarbidopa or foslevodopa; or if you have any other allergies.||
0407|128|P|This product may contain inactive ingredients, which can cause||
0407|129|P|allergic reactions or other problems. Talk to your pharmacist for||
0407|130|P|more details.||
0407|131|P|   Before using this medication, tell your doctor or pharmacist||
0407|132|P|your medical history, especially of: liver disease, glaucoma,||
0407|133|P|breathing problems (such as asthma), heart disease (such as heart||
0407|134|P|attack, irregular heartbeat), kidney disease, stomach/intestinal||
0407|135|P|ulcer, mental/mood disorders (such as depression, schizophrenia),||
0407|136|P|blood disorders, seizures, sleep disorders.||
0407|137|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0407|138|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0407|139|P|machinery, or do anything that needs alertness until you can do||
0407|140|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0407|141|P|are using marijuana (cannabis). See also Side Effects section.||
0407|142|P|   Before having surgery, tell your doctor or dentist about all||
0407|143|P|the products you use (including prescription drugs,||
0407|144|P|nonprescription drugs, and herbal products).||
0407|145|P|   This medication may contain aspartame. If you have||
0407|146|P|phenylketonuria (PKU) or any other condition that requires you to||
0407|147|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
0407|148|P|doctor or pharmacist about using this medication safely.||
0407|149|P|   During pregnancy, this medication should be used only when||
0407|150|P|clearly needed. Discuss the risks and benefits with your doctor.||
0407|151|P|   Levodopa passes into breast milk. It is unknown if carbidopa||
0407|152|P|passes into breast milk. Consult your doctor before||
0407|153|P|breastfeeding.||
0407|154|B|||
0407|155|I|DRUG INTERACTIONS:  See also How to Use section.||
0407|156|I|   Drug interactions may change how your medications work or||
0407|157|I|increase your risk for serious side effects. This document does||
0407|158|I|not contain all possible drug interactions. Keep a list of all||
0407|159|I|the products you use (including prescription/nonprescription||
0407|160|I|drugs and herbal products) and share it with your doctor and||
0407|161|I|pharmacist. Do not start, stop, or change the dosage of any||
0407|162|I|medicines without your doctor's approval.||
0407|163|I|   Taking MAO inhibitors with this medication may cause a serious||
0407|164|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0407|165|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0407|166|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
0407|167|I|treatment with this medication. Most MAO inhibitors should also||
0407|168|I|not be taken for two weeks before treatment with this medication.||
0407|169|I|However, certain MAO inhibitors (rasagiline, safinamide,||
0407|170|I|selegiline) may be used with careful monitoring by your doctor.||
0407|171|I|Ask your doctor when to start or stop taking this medication.||
0407|172|I|   This medication may interfere with certain lab tests (such as||
0407|173|I|urine catecholamine/glucose/ketone tests), possibly causing false||
0407|174|I|test results. Make sure lab personnel and all your doctors know||
0407|175|I|you use this drug.||
0407|176|B|||
0407|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0407|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0407|179|O|poison control center right away. US residents can call||
0407|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0407|181|O|Symptoms of overdose may include: severe dizziness, irregular||
0407|182|O|heartbeat, mental/mood changes (such as agitation).||
0407|183|B|||
0407|184|N|NOTES:  Do not share this medication with others.||
0407|185|N|   Lab and/or medical tests (such as complete blood count,||
0407|186|N|heart/kidney/liver function, blood pressure) should be done while||
0407|187|N|you are taking this medication. Keep all medical and lab||
0407|188|N|appointments. Consult your doctor for more details.||
0407|189|B|||
0407|190|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0407|191|D|remember. If it is near the time of the next dose, skip the||
0407|192|D|missed dose. Take your next dose at the regular time. Do not||
0407|193|D|double the dose to catch up.||
0407|194|B|||
0407|195|R|STORAGE:  Store at room temperature away from light and moisture.||
0407|196|R|Do not store in the bathroom. Keep all medications away from||
0407|197|R|children and pets.||
0407|198|R|   Do not flush medications down the toilet or pour them into a||
0407|199|R|drain unless instructed to do so. Properly discard this product||
0407|200|R|when it is expired or no longer needed. Consult your pharmacist||
0407|201|R|or local waste disposal company.||
0407|202|B|||
0407|203|A|Information last revised April 2025.||
0407|204|A|Copyright(c) 2025 First Databank, Inc.||
0407|205|B|||
0408|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0408|002|Z|does NOT have all possible information about this product. This||
0408|003|Z|information does not assure that this product is safe, effective,||
0408|004|Z|or appropriate for you. This information is not individual||
0408|005|Z|medical advice and does not substitute for the advice of your||
0408|006|Z|health care professional. Always ask your health care||
0408|007|Z|professional for complete information about this product and your||
0408|008|Z|specific health needs.||
0408|009|B|||
0408|010|T|OMEPRAZOLE/SODIUM BICARBONATE - ORAL||
0408|011|F|(oh-MEP-ra-zole/SOE-dee-um bye-KAR-bo-nate)||
0408|012|B|||
0408|013|C|COMMON BRAND NAME(S): Konvomep, Zegerid||
0408|014|B|||
0408|015|U|USES:  This medication is a combination of omeprazole and sodium||
0408|016|U|bicarbonate. It is used to treat certain stomach and esophagus||
0408|017|U|problems (such as acid reflux, ulcers). It is also used to||
0408|018|U|prevent stomach bleeding in very ill patients.||
0408|019|U|   Omeprazole works by decreasing the amount of acid your stomach||
0408|020|U|makes. It belongs to a class of drugs known as proton pump||
0408|021|U|inhibitors (PPIs). Sodium bicarbonate is an antacid that reduces||
0408|022|U|stomach acid and helps omeprazole to work better. This medication||
0408|023|U|relieves symptoms such as heartburn, difficulty swallowing, and||
0408|024|U|cough. It helps heal acid damage to the stomach and esophagus,||
0408|025|U|helps prevent ulcers, and may help prevent cancer of the||
0408|026|U|esophagus.||
0408|027|U|   If you are self-treating with this medication,||
0408|028|U|over-the-counter omeprazole/sodium bicarbonate products are used||
0408|029|U|to treat frequent heartburn (occurring 2 or more days a week).||
0408|030|U|Since it may take 1 to 4 days to have full effect, these products||
0408|031|U|do not relieve heartburn right away.||
0408|032|U|   For over-the-counter products, carefully read the package||
0408|033|U|instructions to make sure the product is right for you. Check the||
0408|034|U|ingredients on the label even if you have used the product||
0408|035|U|before. The manufacturer may have changed the ingredients. Also,||
0408|036|U|products with similar brand names may contain different||
0408|037|U|ingredients meant for different purposes. Taking the wrong||
0408|038|U|product could harm you.||
0408|039|B|||
0408|040|H|HOW TO USE:  Read the Medication Guide provided by your||
0408|041|H|pharmacist before you start taking this medication and each time||
0408|042|H|you get a refill. If you have any questions, ask your doctor or||
0408|043|H|pharmacist.||
0408|044|H|   Take this medication by mouth on an empty stomach (at least 1||
0408|045|H|hour before a meal) as directed by your doctor, usually once||
0408|046|H|daily. If you are self-treating, follow all directions on the||
0408|047|H|product package. The dosage and length of treatment are based on||
0408|048|H|your medical condition and response to treatment. Children's||
0408|049|H|dosage is also based on weight. Do not increase your dose or take||
0408|050|H|this drug more often than directed. If you have any questions,||
0408|051|H|ask your doctor or pharmacist.||
0408|052|H|   If you are taking the capsule, swallow it whole with a full||
0408|053|H|glass of water (8 ounces/240 milliliters). Do not use other||
0408|054|H|liquids. Do not open the capsule or sprinkle the contents into||
0408|055|H|food.||
0408|056|H|   If you are using the powder packet, empty the contents into a||
0408|057|H|small cup with 1 to 2 tablespoons (15 to 30 milliliters) of||
0408|058|H|water. Do not use any other liquids or foods. Stir well and drink||
0408|059|H|the entire mixture right away. To make sure you take the entire||
0408|060|H|dose, add more water to the cup and drink all of it.||
0408|061|H|   If you are using the suspension, shake the bottle well before||
0408|062|H|each dose. Carefully measure the dose using a special measuring||
0408|063|H|device/spoon. Do not use a household spoon because you may not||
0408|064|H|get the correct dose.||
0408|065|H|   If you are giving the powder or suspension through a tube into||
0408|066|H|the stomach (nasogastric or gastric tube), ask your health care||
0408|067|H|professional for detailed instructions on how to properly give||
0408|068|H|it. For patients receiving continuous tube feedings, the tube||
0408|069|H|feeding should be stopped for 3 hours before and 1 hour after||
0408|070|H|giving this medication.||
0408|071|H|   Do not substitute the capsules, the powder packets, or the||
0408|072|H|suspension for each other, unless approved by your doctor,||
0408|073|H|because they contain different amounts of sodium bicarbonate.||
0408|074|H|Also, do not substitute one strength of the same dosage form for||
0408|075|H|another strength (such as taking two 20-milligram capsules||
0408|076|H|instead of one 40-milligram capsule). Doing so may give you too||
0408|077|H|much sodium bicarbonate and increase your risk of side effects||
0408|078|H|(such as swelling of the hands/feet).||
0408|079|H|   If you are also taking sucralfate, take this medication at||
0408|080|H|least 30 minutes before sucralfate.||
0408|081|H|   Use this medication regularly to get the most benefit from it.||
0408|082|H|To help you remember, take it at the same time each day. Continue||
0408|083|H|to take this medication for the prescribed length of treatment||
0408|084|H|even if you are feeling better. If you are self-treating with the||
0408|085|H|over-the-counter product, do not take it for more than 14 days||
0408|086|H|unless directed by your doctor.||
0408|087|H|   Tell your doctor if your condition lasts or gets worse. If you||
0408|088|H|are self-treating, tell your doctor if your heartburn lasts after||
0408|089|H|14 days or if you need to use this medication more than once||
0408|090|H|every 4 months. The risk of side effects goes up over time. Ask||
0408|091|H|your doctor how long you should take this medication. If you||
0408|092|H|think you may have a serious medical problem, get medical help||
0408|093|H|right away.||
0408|094|B|||
0408|095|S|SIDE EFFECTS:  See also Precautions section.||
0408|096|S|   Headache or abdominal pain may occur. If any of these effects||
0408|097|S|last or get worse, tell your doctor or pharmacist promptly.||
0408|098|S|   If your doctor has directed you to use this product, remember||
0408|099|S|that your doctor has judged that the benefit to you is greater||
0408|100|S|than the risk of side effects. Many people using this medication||
0408|101|S|do not have serious side effects.||
0408|102|S|   Tell your doctor right away if you have any serious side||
0408|103|S|effects, including: swelling of the hands/feet, symptoms of a low||
0408|104|S|magnesium blood level (such as muscle spasms, irregular||
0408|105|S|heartbeat, seizures), sudden weight gain, signs of lupus (such as||
0408|106|S|rash on nose and cheeks, new or worsening joint pain), signs of||
0408|107|S|kidney problems (such as change in the amount of urine,||
0408|108|S|pink/bloody urine).||
0408|109|S|   When taken with sodium bicarbonate, large doses of calcium||
0408|110|S|from your diet, medications, or supplements can rarely cause a||
0408|111|S|serious problem called milk-alkali syndrome. Ask your doctor or||
0408|112|S|pharmacist about using calcium products safely while you are||
0408|113|S|using this medication. Tell your doctor right away if any of||
0408|114|S|these serious side effects occur: dizziness, muscle aches/spasms,||
0408|115|S|mental/mood changes (such as confusion, irritability, memory||
0408|116|S|problems), vomiting, weakness.||
0408|117|S|   This medication may rarely cause a severe intestinal condition||
0408|118|S|due to a bacteria called C. difficile. This condition may occur||
0408|119|S|during treatment or weeks to months after treatment has stopped.||
0408|120|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0408|121|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0408|122|S|stool.||
0408|123|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0408|124|S|products because they may make symptoms worse.||
0408|125|S|   Rarely, proton pump inhibitors (such as omeprazole) have||
0408|126|S|caused vitamin B-12 deficiency. The risk is increased if they are||
0408|127|S|taken every day for a long time (3 years or longer). Tell your||
0408|128|S|doctor right away if you develop symptoms of vitamin B-12||
0408|129|S|deficiency (such as unusual weakness, sore tongue, or||
0408|130|S|numbness/tingling of the hands/feet).||
0408|131|S|   A very serious allergic reaction to this drug is rare.||
0408|132|S|However, get medical help right away if you notice any symptoms||
0408|133|S|of a serious allergic reaction, including: fever, swollen lymph||
0408|134|S|nodes, rash, itching/swelling (especially of the||
0408|135|S|face/tongue/throat), severe dizziness, trouble breathing.||
0408|136|S|   This is not a complete list of possible side effects. If you||
0408|137|S|notice other effects not listed above, contact your doctor or||
0408|138|S|pharmacist.||
0408|139|S|   In the US -||
0408|140|S|   Call your doctor for medical advice about side effects. You||
0408|141|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0408|142|S|www.fda.gov/medwatch.||
0408|143|S|   In Canada - Call your doctor for medical advice about side||
0408|144|S|effects. You may report side effects to Health Canada at||
0408|145|S|1-866-234-2345.||
0408|146|B|||
0408|147|P|PRECAUTIONS:  Before taking omeprazole/sodium bicarbonate, tell||
0408|148|P|your doctor or pharmacist if you are allergic to it; or to||
0408|149|P|similar drugs (such as esomeprazole, lansoprazole, pantoprazole);||
0408|150|P|or if you have any other allergies. This product may contain||
0408|151|P|inactive ingredients, which can cause allergic reactions or other||
0408|152|P|problems. Talk to your pharmacist for more details.||
0408|153|P|   Before taking this medication, tell your doctor or pharmacist||
0408|154|P|your medical history, especially of: kidney problems (such as||
0408|155|P|Bartter's syndrome, kidney failure), liver disease (such as||
0408|156|P|cirrhosis), low blood calcium or potassium levels, metabolic||
0408|157|P|imbalance (such as acid-base balance problems), lupus.||
0408|158|P|   This medication contains salt (sodium). Consult your doctor or||
0408|159|P|pharmacist if you are on a low-salt diet or if you have a||
0408|160|P|condition which could be worsened with an increase in salt intake||
0408|161|P|(such as heart failure, swelling/edema).||
0408|162|P|   Some symptoms may actually be signs of a more serious||
0408|163|P|condition. Get medical help right away if you have: heartburn||
0408|164|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
0408|165|P|pain (especially with shortness of breath, unusual sweating),||
0408|166|P|unexplained weight loss.||
0408|167|P|   In addition, before you self-treat with this medication, get||
0408|168|P|medical help right away if you have any of these signs of a||
0408|169|P|serious condition: trouble/pain swallowing food, bloody vomit,||
0408|170|P|vomit that looks like coffee grounds, bloody/black stools,||
0408|171|P|heartburn for over 3 months, frequent chest pain, frequent||
0408|172|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
0408|173|P|pain.||
0408|174|P|   Before having surgery, tell your doctor or dentist about all||
0408|175|P|the products you use (including prescription drugs,||
0408|176|P|nonprescription drugs, and herbal products).||
0408|177|P|   The suspension form may contain sugar. Caution is advised if||
0408|178|P|you have diabetes or any other condition that requires you to||
0408|179|P|limit/avoid sugar in your diet. Ask your doctor or pharmacist||
0408|180|P|about using this product safely.||
0408|181|P|   Proton pump inhibitors (such as omeprazole) may increase your||
0408|182|P|risk for bone fractures, especially with longer use, higher||
0408|183|P|doses, and in older adults. Talk with your doctor or pharmacist||
0408|184|P|about ways to prevent bone loss/fracture, such as by taking||
0408|185|P|calcium (such as calcium citrate) and vitamin D supplements.||
0408|186|P|   Older adults may be more sensitive to the side effects of this||
0408|187|P|drug, especially bone loss and fractures (see above), and C.||
0408|188|P|difficile infection (see Side Effects section).||
0408|189|P|   Children may be more sensitive to the side effects of||
0408|190|P|omeprazole, especially fever, cough, and infections of the||
0408|191|P|nose/throat/airways.||
0408|192|P|   During pregnancy, this medication should be used only when||
0408|193|P|clearly needed. Discuss the risks and benefits with your doctor.||
0408|194|P|   This medication passes into breast milk. The effects on a||
0408|195|P|nursing infant are unknown. Consult your doctor before||
0408|196|P|breastfeeding.||
0408|197|B|||
0408|198|I|DRUG INTERACTIONS:  See also How to Use section.||
0408|199|I|   Drug interactions may change how your medications work or||
0408|200|I|increase your risk for serious side effects. This document does||
0408|201|I|not contain all possible drug interactions. Keep a list of all||
0408|202|I|the products you use (including prescription/nonprescription||
0408|203|I|drugs and herbal products) and share it with your doctor and||
0408|204|I|pharmacist. Do not start, stop, or change the dosage of any||
0408|205|I|medicines without your doctor's approval.||
0408|206|I|   Some products that may interact with this drug include:||
0408|207|I|clopidogrel, memantine, methotrexate (especially high-dose||
0408|208|I|treatment), rifampin, St John's wort.||
0408|209|I|   Some products need stomach acid so that the body can absorb||
0408|210|I|them properly. Omeprazole/sodium bicarbonate decreases stomach||
0408|211|I|acid, so it may change how well these products work. Some||
0408|212|I|affected products include atazanavir, erlotinib,||
0408|213|I|levoketoconazole, nelfinavir, pazopanib, rilpivirine, sparsentan,||
0408|214|I|certain azole antifungals (itraconazole, ketoconazole,||
0408|215|I|posaconazole), among others.||
0408|216|I|   Omeprazole is very similar to esomeprazole. Do not use any||
0408|217|I|medications containing esomeprazole while using omeprazole.||
0408|218|I|   This medication may interfere with certain lab tests, possibly||
0408|219|I|causing false test results. Make sure lab personnel and all your||
0408|220|I|doctors know you use this drug.||
0408|221|B|||
0408|222|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0408|223|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0408|224|O|poison control center right away. US residents can call||
0408|225|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0408|226|O|Symptoms of overdose may include: confusion, unusual sweating,||
0408|227|O|blurred vision, unusually fast heartbeat, seizures.||
0408|228|B|||
0408|229|N|NOTES:  If your doctor has prescribed this medication for you, do||
0408|230|N|not share it with others.||
0408|231|N|   If your doctor instructs you to use this medication regularly||
0408|232|N|for a long time, lab and/or medical tests (such as a magnesium||
0408|233|N|blood test, vitamin B-12 levels) may be done while you are taking||
0408|234|N|this medication. Keep all medical and lab appointments. Consult||
0408|235|N|your doctor for more details.||
0408|236|B|||
0408|237|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0408|238|D|remember. If it is near the time of the next dose, skip the||
0408|239|D|missed dose. Take your next dose at the regular time. Do not||
0408|240|D|double the dose to catch up.||
0408|241|B|||
0408|242|R|STORAGE:  Store the capsules and powder packets at room||
0408|243|R|temperature away from light and moisture. Do not store in the||
0408|244|R|bathroom. Do not open the packets until you are ready to use the||
0408|245|R|medication. Store the suspension in the refrigerator away from||
0408|246|R|light. Do not freeze. Discard any unused suspension after 30||
0408|247|R|days. Keep all medications away from children and pets.||
0408|248|R|   Do not flush medications down the toilet or pour them into a||
0408|249|R|drain unless instructed to do so. Properly discard this product||
0408|250|R|when it is expired or no longer needed. Consult your pharmacist||
0408|251|R|or local waste disposal company.||
0408|252|B|||
0408|253|A|Information last revised April 2025.||
0408|254|A|Copyright(c) 2025 First Databank, Inc.||
0408|255|B|||
0410|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0410|002|Z|does NOT have all possible information about this product. This||
0410|003|Z|information does not assure that this product is safe, effective,||
0410|004|Z|or appropriate for you. This information is not individual||
0410|005|Z|medical advice and does not substitute for the advice of your||
0410|006|Z|health care professional. Always ask your health care||
0410|007|Z|professional for complete information about this product and your||
0410|008|Z|specific health needs.||
0410|009|B|||
0410|010|T|CETUXIMAB - INJECTION||
0410|011|F|(se-TUX-i-mab)||
0410|012|B|||
0410|013|C|COMMON BRAND NAME(S): Erbitux||
0410|014|B|||
0410|015|W|WARNING:  Severe (sometimes fatal) reactions have occurred in||
0410|016|W|people while receiving cetuximab. Your risk may be higher if you||
0410|017|W|have a history of tick bites or have a severe allergic reaction||
0410|018|W|to meat (such as beef, pork). Before receiving cetuximab, tell||
0410|019|W|your doctor if you have either of these conditions. Your doctor||
0410|020|W|will carefully monitor you during and for at least one hour after||
0410|021|W|your infusion. Tell your doctor right away if you have shortness||
0410|022|W|of breath, hoarseness, itching, or dizziness. Your doctor may||
0410|023|W|stop treatment with this medication if you have a severe||
0410|024|W|reaction.||
0410|025|W|   Rare deaths due to heart problems (cardiopulmonary arrest) or||
0410|026|W|sudden death have occurred in people with head and neck cancer||
0410|027|W|treated with cetuximab. Before starting treatment with this||
0410|028|W|medication, tell your doctor if you have a history of heart||
0410|029|W|disease (such as heart failure, irregular heartbeat, previous||
0410|030|W|heart attack). Get medical help right away if you develop||
0410|031|W|chest/jaw/left arm pain, shortness of breath, or unusual||
0410|032|W|sweating. Your doctor will order certain blood tests (including||
0410|033|W|magnesium, calcium, and potassium) during and after your||
0410|034|W|treatment to monitor and help decrease your risk for heart||
0410|035|W|problems.||
0410|036|B|||
0410|037|U|USES:  Cetuximab is used to treat a certain type of cancer of the||
0410|038|U|colon (large intestine) or rectum. This medication is also used||
0410|039|U|to treat head and neck cancer. Cetuximab works by slowing or||
0410|040|U|stopping the growth of cancer cells. It binds to a certain||
0410|041|U|protein (epidermal growth factor receptor-EGFR) in some tumors.||
0410|042|U|Cetuximab is a man-made protein (monoclonal antibody).||
0410|043|B|||
0410|044|V|OTHER USES:  This section contains uses of this drug that are not||
0410|045|V|listed in the approved professional labeling for the drug but||
0410|046|V|that may be prescribed by your health care professional. Use this||
0410|047|V|drug for a condition that is listed in this section only if it||
0410|048|V|has been so prescribed by your health care professional.||
0410|049|V|   Cetuximab may also be used for kidney cancer.||
0410|050|B|||
0410|051|H|HOW TO USE:  Cetuximab is given by injection into a vein as||
0410|052|H|directed by your doctor, usually once every week or every 2 weeks||
0410|053|H|by a healthcare professional. Another drug (such as||
0410|054|H|diphenhydramine) may be given before you receive cetuximab to||
0410|055|H|lessen the chance of certain side effects. The dosage is based on||
0410|056|H|your medical condition, body size, and response to treatment.||
0410|057|H|   A healthcare professional should watch you for at least 1 hour||
0410|058|H|after your infusion is finished to make sure you do not have an||
0410|059|H|infusion reaction. (See Warning section). If you experience a||
0410|060|H|severe infusion reaction, your infusion will be stopped and your||
0410|061|H|doctor may decide to stop further treatments.||
0410|062|B|||
0410|063|S|SIDE EFFECTS:  See also Warning section.||
0410|064|S|   Nausea, vomiting, constipation, diarrhea, headache,||
0410|065|S|stomachache, backache, fever/chills, trouble sleeping, weight||
0410|066|S|loss, tiredness, drowsiness, eye redness/itching, nail changes,||
0410|067|S|dry skin, and mouth/throat sores may occur. Nausea and vomiting||
0410|068|S|can be quite severe. In some cases, drug therapy may be necessary||
0410|069|S|to prevent or relieve nausea and vomiting. Not eating before your||
0410|070|S|treatment may help relieve vomiting. Changes in diet such as||
0410|071|S|eating several small meals or limiting activity may help lessen||
0410|072|S|some of these effects. If any of these effects last or get worse,||
0410|073|S|tell your doctor or pharmacist promptly.||
0410|074|S|   People using this medication may have serious side effects.||
0410|075|S|However, you have been prescribed this drug because your doctor||
0410|076|S|has judged that the benefit to you is greater than the risk of||
0410|077|S|side effects. Careful monitoring by your doctor may decrease your||
0410|078|S|risk.||
0410|079|S|   An acne-like rash may occur. Depending on how severe this rash||
0410|080|S|is, your doctor may delay your cetuximab treatment, lower your||
0410|081|S|dose, treat the rash with antibiotics, or stop treatment with||
0410|082|S|cetuximab to decrease this potentially serious side effect.||
0410|083|S|   Tell your doctor right away if you have any serious side||
0410|084|S|effects, including: mental/mood changes (such as confusion,||
0410|085|S|depression), swelling of hands/feet/lower legs, signs of||
0410|086|S|dehydration (such as unusual dry mouth/thirst,||
0410|087|S|dizziness/lightheadedness), signs of infection (such as sore||
0410|088|S|throat that doesn't go away, fever, chills), signs of kidney||
0410|089|S|problems (such as change in the amount of urine), decreased||
0410|090|S|vision, fast/slow/irregular heartbeat, muscle spasms.||
0410|091|S|   Rarely, very serious lung problems may occur. Get medical help||
0410|092|S|right away if you develop: trouble breathing, chest pain.||
0410|093|S|   A very serious allergic reaction to this drug is rare.||
0410|094|S|However, get medical help right away if you notice any symptoms||
0410|095|S|of a serious allergic reaction, including: rash, itching/swelling||
0410|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0410|097|S|breathing.||
0410|098|S|   This is not a complete list of possible side effects. If you||
0410|099|S|notice other effects not listed above, contact your doctor or||
0410|100|S|pharmacist.||
0410|101|S|   In the US -||
0410|102|S|   Call your doctor for medical advice about side effects. You||
0410|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0410|104|S|www.fda.gov/medwatch.||
0410|105|S|   In Canada - Call your doctor for medical advice about side||
0410|106|S|effects. You may report side effects to Health Canada at||
0410|107|S|1-866-234-2345.||
0410|108|B|||
0410|109|P|PRECAUTIONS:  See also Warning section.||
0410|110|P|   Before receiving cetuximab, tell your doctor or pharmacist if||
0410|111|P|you are allergic to it, or if you have a severe allergy to meat||
0410|112|P|(such as beef, pork), or if you have any other allergies. This||
0410|113|P|product may contain inactive ingredients, which can cause||
0410|114|P|allergic reactions or other problems. Talk to your pharmacist for||
0410|115|P|more details.||
0410|116|P|   Before using this medication, tell your doctor or pharmacist||
0410|117|P|your medical history, especially of: lung disease, radiation||
0410|118|P|therapy, heart disease (such as coronary artery disease, heart||
0410|119|P|failure, arrhythmias), tick bites.||
0410|120|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
0410|121|P|can make you more drowsy. Do not drive, use machinery, or do||
0410|122|P|anything that needs alertness until you can do it safely. Limit||
0410|123|P|alcoholic beverages. Talk to your doctor if you are using||
0410|124|P|marijuana (cannabis).||
0410|125|P|   Sunlight may worsen any skin reactions that may occur while||
0410|126|P|you are using this drug. Avoid prolonged sun exposure, tanning||
0410|127|P|booths, and sunlamps during treatment and for 2 months after your||
0410|128|P|last treatment with cetuximab. Use a sunscreen and wear||
0410|129|P|protective clothing when outdoors.||
0410|130|P|   Before having surgery, tell your doctor or dentist about all||
0410|131|P|the products you use (including prescription drugs,||
0410|132|P|nonprescription drugs, and herbal products).||
0410|133|P|   Tell your doctor if you are pregnant or plan to become||
0410|134|P|pregnant. You should not become pregnant while using cetuximab.||
0410|135|P|Cetuximab may harm an unborn baby. Ask about reliable forms of||
0410|136|P|birth control while using this medication and for 2 months after||
0410|137|P|the last dose. If you become pregnant, talk to your doctor right||
0410|138|P|away about the risks and benefits of this medication.||
0410|139|P|   Based on information from related drugs, cetuximab may pass||
0410|140|P|into breast milk. Because of the possible risk to the infant,||
0410|141|P|breastfeeding is not recommended while using cetuximab and for 2||
0410|142|P|months after the last dose. Consult your doctor before||
0410|143|P|breastfeeding.||
0410|144|B|||
0410|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0410|146|I|medications work or increase your risk for serious side effects.||
0410|147|I|This document does not contain all possible drug interactions.||
0410|148|I|Keep a list of all the products you use (including||
0410|149|I|prescription/nonprescription drugs and herbal products) and share||
0410|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
0410|151|I|the dosage of any medicines without your doctor's approval.||
0410|152|B|||
0410|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0410|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0410|155|O|poison control center right away. US residents can call||
0410|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0410|157|B|||
0410|158|N|NOTES:  Lab and/or medical tests (such as calcium, magnesium,||
0410|159|N|potassium levels) should be done while you are using this||
0410|160|N|medication and for up to 8 weeks after your last infusion. Keep||
0410|161|N|all medical and lab appointments. Consult your doctor for more||
0410|162|N|details.||
0410|163|B|||
0410|164|D|MISSED DOSE:  It is important to get each dose of cetuximab as||
0410|165|D|scheduled. If you miss a dose, ask your doctor or pharmacist||
0410|166|D|right away for a new dosing schedule.||
0410|167|B|||
0410|168|R|STORAGE:  Not applicable. This medication is given in a hospital||
0410|169|R|or clinic and will not be stored at home.||
0410|170|B|||
0410|171|A|Information last revised April 2025.||
0410|172|A|Copyright(c) 2025 First Databank, Inc.||
0410|173|B|||
0411|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0411|002|Z|does NOT have all possible information about this product. This||
0411|003|Z|information does not assure that this product is safe, effective,||
0411|004|Z|or appropriate for you. This information is not individual||
0411|005|Z|medical advice and does not substitute for the advice of your||
0411|006|Z|health care professional. Always ask your health care||
0411|007|Z|professional for complete information about this product and your||
0411|008|Z|specific health needs.||
0411|009|B|||
0411|010|T|DALTEPARIN AMPULES SUBCUTANEOUS OR INTRAVENOUS - INJECTION||
0411|011|F|(DAL-te-PAR-in)||
0411|012|B|||
0411|013|W|WARNING:  People using this medication may bleed near the spinal||
0411|014|W|cord after certain spinal procedures. Bleeding in this area can||
0411|015|W|cause paralysis that lasts a long time or could become permanent.||
0411|016|W|Talk with your doctor about the benefits and risks before any||
0411|017|W|spinal procedure. Your doctor may direct you to stop this||
0411|018|W|medication for a certain amount of time before and after the||
0411|019|W|procedure. Carefully follow your doctor's directions.||
0411|020|W|   The risk of bleeding may be higher if you have a deformed||
0411|021|W|spine, or have had spinal procedures/surgery before (such as||
0411|022|W|epidural catheter placement, difficult epidural/spinal puncture),||
0411|023|W|or are taking other drugs that can cause bleeding/bruising||
0411|024|W|(including antiplatelet drugs such as clopidogrel, "blood||
0411|025|W|thinners" such as warfarin/rivaroxaban, nonsteroidal||
0411|026|W|anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your||
0411|027|W|doctor right away if you notice symptoms such as back pain, leg||
0411|028|W|numbness/tingling/weakness, loss of control of the bowels or||
0411|029|W|bladder (incontinence).||
0411|030|B|||
0411|031|U|USES:  Dalteparin is used to prevent and treat harmful blood||
0411|032|U|clots. Preventing harmful blood clots helps to reduce the risk of||
0411|033|U|a stroke or heart attack. This medication helps keep your blood||
0411|034|U|flowing smoothly by lowering the activity of clotting proteins in||
0411|035|U|the blood. Dalteparin is a type of heparin, and works as an||
0411|036|U|anticoagulant (commonly called a "blood thinner").||
0411|037|U|   Conditions that increase your risk of developing blood clots||
0411|038|U|include certain types of surgeries (such as hip replacement or||
0411|039|U|abdominal surgery), long periods of being in one position||
0411|040|U|(immobile), certain types of heart attack, and a certain type of||
0411|041|U|chest pain called unstable angina. For some medical conditions,||
0411|042|U|dalteparin may be used in combination with other "blood||
0411|043|U|thinners."||
0411|044|U|   Dalteparin may also be used to treat and prevent clots from||
0411|045|U|coming back in patients with cancer. It may also be used to||
0411|046|U|prevent clotting in certain equipment used by patients on||
0411|047|U|hemodialysis.||
0411|048|B|||
0411|049|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0411|050|H|from your pharmacist before you start using dalteparin and each||
0411|051|H|time you get a refill. If you have any questions, ask your doctor||
0411|052|H|or pharmacist.||
0411|053|H|   Inject this medication under the skin as directed by your||
0411|054|H|doctor, usually once or twice daily. The injection is given in||
0411|055|H|the abdomen or thighs. Do not inject into a muscle. The dosage||
0411|056|H|and length of treatment are based on your medical condition,||
0411|057|H|weight, and response to treatment. This medication may also be||
0411|058|H|given by injection into a vein by a health care professional, as||
0411|059|H|directed by your doctor, for certain conditions.||
0411|060|H|   If you are using this medication at home, learn all||
0411|061|H|preparation and usage instructions from your health care||
0411|062|H|professional and the product package. Before using, check this||
0411|063|H|product for particles or discoloration. If either is present, do||
0411|064|H|not use the liquid. This medication should not be mixed with or||
0411|065|H|added to any other medication. Before injecting each dose, clean||
0411|066|H|the skin you are going to inject into (the injection site) with||
0411|067|H|rubbing alcohol. Change the injection site each time to lessen||
0411|068|H|injury under the skin. To lessen bruising, do not rub the||
0411|069|H|injection site after a shot. Learn how to store and discard||
0411|070|H|medical supplies safely.||
0411|071|H|   To prevent blood clots due to surgery, your doctor may direct||
0411|072|H|you to start using this medication before or after surgery and||
0411|073|H|continue for several days. Follow your doctor's directions||
0411|074|H|closely.||
0411|075|H|   Use this medication regularly to get the most benefit from it.||
0411|076|H|To help you remember, use it at the same time(s) each day.||
0411|077|B|||
0411|078|S|SIDE EFFECTS:  See also Warning section.||
0411|079|S|   Irritation, bruising, and pain at the injection site may||
0411|080|S|occur. If any of these effects last or get worse, tell your||
0411|081|S|doctor or pharmacist promptly.||
0411|082|S|   Remember that this medication has been prescribed because your||
0411|083|S|doctor has judged that the benefit to you is greater than the||
0411|084|S|risk of side effects. Many people using this medication do not||
0411|085|S|have serious side effects.||
0411|086|S|   This medication can cause bleeding if its effect on your blood||
0411|087|S|clotting proteins is too much. Tell your doctor right away if you||
0411|088|S|have any serious signs of bleeding, including: unusual||
0411|089|S|pain/swelling/discomfort, unusual or prolonged bleeding, unusual||
0411|090|S|or easy bruising, dark urine, black stools, severe headache,||
0411|091|S|confusion, vision changes, unusual dizziness, fainting, seizures,||
0411|092|S|weakness, numbness.||
0411|093|S|   A very serious allergic reaction to this drug is rare.||
0411|094|S|However, get medical help right away if you notice any symptoms||
0411|095|S|of a serious allergic reaction, including: rash, itching/swelling||
0411|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0411|097|S|breathing.||
0411|098|S|   This is not a complete list of possible side effects. If you||
0411|099|S|notice other effects not listed above, contact your doctor or||
0411|100|S|pharmacist.||
0411|101|S|   In the US -||
0411|102|S|   Call your doctor for medical advice about side effects. You||
0411|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0411|104|S|www.fda.gov/medwatch.||
0411|105|S|   In Canada - Call your doctor for medical advice about side||
0411|106|S|effects. You may report side effects to Health Canada at||
0411|107|S|1-866-234-2345.||
0411|108|B|||
0411|109|P|PRECAUTIONS:  Before using dalteparin, tell your doctor or||
0411|110|P|pharmacist if you are allergic to it; or to heparins or pork||
0411|111|P|products; or if you have any other allergies. This product may||
0411|112|P|contain inactive ingredients (such as benzyl alcohol), which can||
0411|113|P|cause allergic reactions or other problems. Talk to your||
0411|114|P|pharmacist for more details.||
0411|115|P|   Before using this medication, tell your doctor or pharmacist||
0411|116|P|your medical history, especially of: serious active bleeding,||
0411|117|P|artificial heart valves, bleeding or blood disorders (low||
0411|118|P|platelet counts), certain eye problems (hypertensive or diabetic||
0411|119|P|retinopathy), high blood pressure, infection of the heart, kidney||
0411|120|P|disease, liver disease, low platelet counts after previous||
0411|121|P|heparin treatment, certain stomach/intestinal problems (such as||
0411|122|P|active or recent ulcers), stroke, recent spinal procedures or||
0411|123|P|puncture, spine problems (such as spinal deformity), recent||
0411|124|P|eye/brain/spinal cord surgery.||
0411|125|P|   Limit alcohol while using this drug because it may increase||
0411|126|P|the risk of stomach bleeding.||
0411|127|P|   Before having surgery, tell your doctor or dentist about all||
0411|128|P|the products you use (including prescription drugs,||
0411|129|P|nonprescription drugs, and herbal products).||
0411|130|P|   To lower the chance of getting cut, bruised, or injured, use||
0411|131|P|caution with sharp objects like razors and nail cutters, and||
0411|132|P|avoid activities such as contact sports.||
0411|133|P|   Older adults may be more sensitive to the side effects of this||
0411|134|P|drug, especially bleeding.||
0411|135|P|   During pregnancy, this medication should be used only when||
0411|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
0411|137|P|   This medication passes into breast milk. Consult your doctor||
0411|138|P|before breastfeeding.||
0411|139|B|||
0411|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0411|141|I|medications work or increase your risk for serious side effects.||
0411|142|I|This document does not contain all possible drug interactions.||
0411|143|I|Keep a list of all the products you use (including||
0411|144|I|prescription/nonprescription drugs and herbal products) and share||
0411|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
0411|146|I|the dosage of any medicines without your doctor's approval.||
0411|147|I|   A product that may interact with this drug is: mifepristone.||
0411|148|I|   This medication is sometimes used together with other drugs||
0411|149|I|that have "blood thinning" or anti-platelet effects such as||
0411|150|I|aspirin, clopidogrel, or warfarin. When these combinations are||
0411|151|I|prescribed by your doctor, you will require closer monitoring to||
0411|152|I|minimize your risk of bleeding. Keep all medical and lab||
0411|153|I|appointments.||
0411|154|I|   Check all prescription and nonprescription medicine labels||
0411|155|I|carefully since many medications contain pain relievers/fever||
0411|156|I|reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) which||
0411|157|I|can increase the risk of bleeding/anti-platelet effect when used||
0411|158|I|with dalteparin. However, if your doctor has told you to take||
0411|159|I|low-dose aspirin to prevent heart attack or stroke (usually||
0411|160|I|81-162 milligrams a day), you should keep taking the aspirin||
0411|161|I|unless your doctor tells you not to. Ask your doctor or||
0411|162|I|pharmacist for more details.||
0411|163|B|||
0411|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0411|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0411|166|O|poison control center right away. US residents can call||
0411|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0411|168|O|Symptoms of overdose may include: excessive bleeding and||
0411|169|O|bruising.||
0411|170|B|||
0411|171|N|NOTES:  Do not share this medication with others.||
0411|172|N|   Lab and/or medical tests (such as complete blood count,||
0411|173|N|anti-factor Xa blood levels) should be done while you are using||
0411|174|N|this medication. Keep all medical and lab appointments. Consult||
0411|175|N|your doctor for more details.||
0411|176|B|||
0411|177|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0411|178|D|If it is near the time of the next dose, skip the missed dose.||
0411|179|D|Use your next dose at the regular time. Do not double the dose to||
0411|180|D|catch up.||
0411|181|B|||
0411|182|R|STORAGE:  Store at room temperature. Keep all medications away||
0411|183|R|from children and pets.||
0411|184|R|   Do not flush medications down the toilet or pour them into a||
0411|185|R|drain unless instructed to do so. Properly discard this product||
0411|186|R|when it is expired or no longer needed. Consult your pharmacist||
0411|187|R|or local waste disposal company.||
0411|188|B|||
0411|189|M|MEDICAL ALERT:  Your condition can cause complications in a||
0411|190|M|medical emergency. For information about enrolling in MedicAlert,||
0411|191|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0411|192|B|||
0411|193|A|Information last revised December 2024.||
0411|194|A|Copyright(c) 2025 First Databank, Inc.||
0411|195|B|||
0413|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0413|002|Z|does NOT have all possible information about this product. This||
0413|003|Z|information does not assure that this product is safe, effective,||
0413|004|Z|or appropriate for you. This information is not individual||
0413|005|Z|medical advice and does not substitute for the advice of your||
0413|006|Z|health care professional. Always ask your health care||
0413|007|Z|professional for complete information about this product and your||
0413|008|Z|specific health needs.||
0413|009|B|||
0413|010|T|MELOXICAM - ORAL||
0413|011|F|(mel-OX-i-kam)||
0413|012|B|||
0413|013|C|COMMON BRAND NAME(S): Mobic, Vivlodex||
0413|014|B|||
0413|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0413|016|W|meloxicam) may rarely increase the risk of a heart attack or||
0413|017|W|stroke. This effect can happen at any time while taking this drug||
0413|018|W|but is more likely if you take it for a long time. The risk may||
0413|019|W|be greater in older adults or if you have heart disease or||
0413|020|W|increased risk for heart disease (for example, due to smoking,||
0413|021|W|family history of heart disease, or conditions such as high blood||
0413|022|W|pressure or diabetes). Do not take this drug right before or||
0413|023|W|after heart bypass surgery (CABG).||
0413|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0413|025|W|bleeding from the stomach or intestines. This effect can occur||
0413|026|W|without warning symptoms at any time while taking this drug.||
0413|027|W|Older adults may be at higher risk for this effect. (See also||
0413|028|W|Precautions and Drug Interactions sections.)||
0413|029|W|   Stop taking meloxicam and get medical help right away if you||
0413|030|W|notice any of the following rare but serious side effects:||
0413|031|W|stomach/abdominal pain that doesn't go away, bloody or||
0413|032|W|black/tarry stools, vomit that looks like coffee grounds,||
0413|033|W|chest/jaw/left arm pain, shortness of breath, unusual sweating,||
0413|034|W|weakness on one side of the body, sudden vision changes, trouble||
0413|035|W|speaking.||
0413|036|W|   Talk with your doctor or pharmacist about the risks and||
0413|037|W|benefits of treatment with this medication.||
0413|038|B|||
0413|039|U|USES:  Meloxicam is used to treat arthritis. It reduces pain,||
0413|040|U|swelling, and stiffness of the joints. Meloxicam is known as a||
0413|041|U|nonsteroidal anti-inflammatory drug (NSAID).||
0413|042|U|   If you are treating a chronic condition such as arthritis, ask||
0413|043|U|your doctor about non-drug treatments and/or using other||
0413|044|U|medications to treat your pain. See also Warning section.||
0413|045|B|||
0413|046|V|OTHER USES:  This section contains uses of this drug that are not||
0413|047|V|listed in the approved professional labeling for the drug but||
0413|048|V|that may be prescribed by your health care professional. Use this||
0413|049|V|drug for a condition that is listed in this section only if it||
0413|050|V|has been so prescribed by your health care professional.||
0413|051|V|   This drug may also be used for gout attacks.||
0413|052|B|||
0413|053|H|HOW TO USE:  Read the Medication Guide provided by your||
0413|054|H|pharmacist before you start taking meloxicam and each time you||
0413|055|H|get a refill. If you have any questions, ask your doctor or||
0413|056|H|pharmacist.||
0413|057|H|   Take this medication by mouth as directed by your doctor,||
0413|058|H|usually once daily. If you are taking the tablet or capsule form||
0413|059|H|of this medication, drink a full glass of water (8 ounces/240||
0413|060|H|milliliters) with it unless your doctor tells you otherwise. Do||
0413|061|H|not lie down for at least 10 minutes after taking the tablet or||
0413|062|H|capsule form of this medication.||
0413|063|H|   If you are taking the liquid form of this medication, shake||
0413|064|H|the bottle gently before each dose. Carefully measure the dose||
0413|065|H|using a special measuring device/spoon. Do not use a household||
0413|066|H|spoon because you may not get the correct dose.||
0413|067|H|   If you are taking the disintegrating tablet, do not remove the||
0413|068|H|tablet from the packaging until you are ready to take it. With||
0413|069|H|dry hands, peel back the foil to carefully remove the tablet. Do||
0413|070|H|not push the tablet through the foil because doing so can damage||
0413|071|H|it. Place the tablet on your tongue right away and allow it to||
0413|072|H|dissolve. After the tablet has melted, it can be swallowed with||
0413|073|H|or without liquid.||
0413|074|H|   If stomach upset occurs while taking this medication, take it||
0413|075|H|with food, milk, or an antacid. The dosage is based on your||
0413|076|H|medical condition and response to treatment. The lowest effective||
0413|077|H|dosage should always be used, and only for the prescribed length||
0413|078|H|of time. Do not take more of this medication than prescribed||
0413|079|H|because higher doses increase the chance of stomach||
0413|080|H|ulcers/bleeding.||
0413|081|H|   Meloxicam may come in different forms (such as tablet,||
0413|082|H|capsule, liquid, disintegrating tablet). Do not switch between||
0413|083|H|different forms without consulting your doctor.||
0413|084|H|   It may take up to two weeks before you get the full benefit of||
0413|085|H|this drug. Use this medication regularly to get the most benefit||
0413|086|H|from it. Remember to use it at the same time each day.||
0413|087|H|   Tell your doctor if your condition gets worse.||
0413|088|B|||
0413|089|S|SIDE EFFECTS:  See also Warning section.||
0413|090|S|   Stomach upset, nausea, dizziness, or diarrhea may occur. If||
0413|091|S|any of these effects last or get worse, tell your doctor or||
0413|092|S|pharmacist promptly.||
0413|093|S|   Remember that this medication has been prescribed because your||
0413|094|S|doctor has judged that the benefit to you is greater than the||
0413|095|S|risk of side effects. Many people using this medication do not||
0413|096|S|have serious side effects.||
0413|097|S|   This medication may raise your blood pressure. Check your||
0413|098|S|blood pressure regularly and tell your doctor if the results are||
0413|099|S|high.||
0413|100|S|   Tell your doctor right away if you have any serious side||
0413|101|S|effects, including: easy bruising/bleeding, mental/mood changes,||
0413|102|S|signs of kidney problems (such as change in the amount of urine),||
0413|103|S|symptoms of heart failure (such as swelling ankles/feet, unusual||
0413|104|S|tiredness, unusual/sudden weight gain).||
0413|105|S|   This drug may rarely cause serious (possibly fatal) liver||
0413|106|S|disease. Get medical help right away if you have any symptoms of||
0413|107|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0413|108|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
0413|109|S|eyes/skin.||
0413|110|S|   A very serious allergic reaction to this drug is rare.||
0413|111|S|However, get medical help right away if you notice any symptoms||
0413|112|S|of a serious allergic reaction, including: fever, swollen lymph||
0413|113|S|nodes, rash, itching/swelling (especially of the||
0413|114|S|face/tongue/throat), severe dizziness, trouble breathing.||
0413|115|S|   This is not a complete list of possible side effects. If you||
0413|116|S|notice other effects not listed above, contact your doctor or||
0413|117|S|pharmacist.||
0413|118|S|   In the US -||
0413|119|S|   Call your doctor for medical advice about side effects. You||
0413|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0413|121|S|www.fda.gov/medwatch.||
0413|122|S|   In Canada - Call your doctor for medical advice about side||
0413|123|S|effects. You may report side effects to Health Canada at||
0413|124|S|1-866-234-2345.||
0413|125|B|||
0413|126|P|PRECAUTIONS:  Before taking meloxicam, tell your doctor or||
0413|127|P|pharmacist if you are allergic to it; or to aspirin or other||
0413|128|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
0413|129|P|any other allergies. This product may contain inactive||
0413|130|P|ingredients, which can cause allergic reactions or other||
0413|131|P|problems. Talk to your pharmacist for more details.||
0413|132|P|   Before using this medication, tell your doctor or pharmacist||
0413|133|P|your medical history, especially of: asthma (including a history||
0413|134|P|of worsening breathing after taking aspirin or other NSAIDs),||
0413|135|P|liver disease, stomach/intestine/esophagus problems (such as||
0413|136|P|bleeding, ulcers, recurring heartburn), heart disease (such as||
0413|137|P|history of heart attack), high blood pressure, stroke, blood||
0413|138|P|disorders (such as anemia, bleeding/clotting problems), growths||
0413|139|P|in the nose (nasal polyps).||
0413|140|P|   Kidney problems can sometimes occur with the use of NSAID||
0413|141|P|medications, including meloxicam. Problems are more likely to||
0413|142|P|occur if you are dehydrated, have heart failure or kidney||
0413|143|P|disease, are an older adult, or if you take certain medications||
0413|144|P|(see also Drug Interactions section). Drink plenty of fluids as||
0413|145|P|directed by your doctor to prevent dehydration and tell your||
0413|146|P|doctor right away if you have a change in the amount of urine.||
0413|147|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0413|148|P|can make you more dizzy. Do not drive, use machinery, or do||
0413|149|P|anything that needs alertness until you can do it safely. Talk to||
0413|150|P|your doctor if you are using marijuana (cannabis).||
0413|151|P|   This medication may cause stomach bleeding. Daily use of||
0413|152|P|alcohol and tobacco, especially when combined with this||
0413|153|P|medication, may increase your risk for stomach bleeding. Limit||
0413|154|P|alcohol and smoking. Consult your doctor or pharmacist for more||
0413|155|P|information.||
0413|156|P|   The disintegrating tablet form of meloxicam may contain||
0413|157|P|aspartame. If you have phenylketonuria (PKU) or any other||
0413|158|P|condition that requires you to limit/avoid aspartame (or||
0413|159|P|phenylalanine) in your diet, ask your doctor or pharmacist about||
0413|160|P|using this medication safely.||
0413|161|P|   This medication may make you more sensitive to the sun. Limit||
0413|162|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0413|163|P|sunscreen and wear protective clothing when outdoors. Tell your||
0413|164|P|doctor right away if you get sunburned or have skin||
0413|165|P|blisters/redness.||
0413|166|P|   Before having surgery, tell your doctor or dentist about all||
0413|167|P|the products you use (including prescription drugs,||
0413|168|P|nonprescription drugs, and herbal products).||
0413|169|P|   Older adults may be at greater risk for stomach/intestinal||
0413|170|P|bleeding, kidney problems, heart attack, and stroke while using||
0413|171|P|this drug.||
0413|172|P|   Before using this medication, women of childbearing age should||
0413|173|P|talk with their doctor(s) about the benefits and risks. Tell your||
0413|174|P|doctor if you are pregnant or if you plan to become pregnant.||
0413|175|P|This medication may harm an unborn baby and cause problems with||
0413|176|P|normal labor/delivery. It is not recommended for use in pregnancy||
0413|177|P|from 20 weeks until delivery. If your doctor decides that you||
0413|178|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0413|179|P|you should use the lowest effective dose for the shortest||
0413|180|P|possible time. You should not use this medication after 30 weeks||
0413|181|P|of pregnancy.||
0413|182|P|   It is unknown if this medication passes into breast milk.||
0413|183|P|However, similar drugs pass into breast milk and are unlikely to||
0413|184|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0413|185|B|||
0413|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0413|187|I|medications work or increase your risk for serious side effects.||
0413|188|I|This document does not contain all possible drug interactions.||
0413|189|I|Keep a list of all the products you use (including||
0413|190|I|prescription/nonprescription drugs and herbal products) and share||
0413|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
0413|192|I|the dosage of any medicines without your doctor's approval.||
0413|193|I|   Some products that may interact with this drug include:||
0413|194|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
0413|195|I|angiotensin II receptor blockers (such as losartan, valsartan),||
0413|196|I|cidofovir, lithium, methotrexate (high-dose treatment), "water||
0413|197|I|pills" (diuretics such as furosemide).||
0413|198|I|   This medication may increase the risk of bleeding when taken||
0413|199|I|with other drugs that also may cause bleeding. Examples include||
0413|200|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0413|201|I|dabigatran/enoxaparin/warfarin, among others.||
0413|202|I|   If you are using the liquid form of meloxicam, tell your||
0413|203|I|doctor if you are also using sodium polystyrene sulfonate.||
0413|204|I|   Check all prescription and nonprescription medicine labels||
0413|205|I|carefully since many medications contain pain relievers/fever||
0413|206|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
0413|207|I|ketorolac). These drugs are similar to meloxicam and may increase||
0413|208|I|your risk of side effects if taken together. However, if your||
0413|209|I|doctor has told you to take low-dose aspirin to prevent heart||
0413|210|I|attack or stroke (usually 81-162 milligrams a day), you should||
0413|211|I|keep taking the aspirin unless your doctor tells you not to. Ask||
0413|212|I|your doctor or pharmacist for more details.||
0413|213|B|||
0413|214|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0413|215|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0413|216|O|poison control center right away. US residents can call||
0413|217|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0413|218|O|Symptoms of overdose may include: slow/shallow breathing, extreme||
0413|219|O|drowsiness, severe stomach pain, vomit that looks like coffee||
0413|220|O|grounds.||
0413|221|B|||
0413|222|N|NOTES:  Do not share this medication with others.||
0413|223|N|   Lab and/or medical tests (such as blood counts, blood||
0413|224|N|pressure, kidney/liver function) may be done while you are taking||
0413|225|N|this medication. Keep all medical and lab appointments. Consult||
0413|226|N|your doctor for more details.||
0413|227|N|   Non-drug treatment for arthritis that is approved by your||
0413|228|N|doctor (such as weight loss if needed, strengthening and||
0413|229|N|conditioning exercises) may help improve your flexibility, range||
0413|230|N|of motion, and joint function. Consult your doctor for more||
0413|231|N|information.||
0413|232|B|||
0413|233|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0413|234|D|remember. If it is near the time of the next dose, skip the||
0413|235|D|missed dose. Take your next dose at the regular time. Do not||
0413|236|D|double the dose to catch up.||
0413|237|B|||
0413|238|R|STORAGE:  Store at room temperature away from light and moisture.||
0413|239|R|Do not store in the bathroom. Keep all medications away from||
0413|240|R|children and pets.||
0413|241|R|   Do not flush medications down the toilet or pour them into a||
0413|242|R|drain unless instructed to do so. Properly discard this product||
0413|243|R|when it is expired or no longer needed. Consult your pharmacist||
0413|244|R|or local waste disposal company.||
0413|245|B|||
0413|246|A|Information last revised November 2024.||
0413|247|A|Copyright(c) 2025 First Databank, Inc.||
0413|248|B|||
0416|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0416|002|Z|does NOT have all possible information about this product. This||
0416|003|Z|information does not assure that this product is safe, effective,||
0416|004|Z|or appropriate for you. This information is not individual||
0416|005|Z|medical advice and does not substitute for the advice of your||
0416|006|Z|health care professional. Always ask your health care||
0416|007|Z|professional for complete information about this product and your||
0416|008|Z|specific health needs.||
0416|009|B|||
0416|010|T|CLINDAMYCIN LIQUID - ORAL||
0416|011|F|(KLIN-da-MYE-sin)||
0416|012|B|||
0416|013|C|COMMON BRAND NAME(S): Cleocin||
0416|014|B|||
0416|015|W|WARNING:  This medication may rarely cause a severe intestinal||
0416|016|W|condition due to a bacteria called C. difficile. This condition||
0416|017|W|may occur during treatment or weeks to months after treatment has||
0416|018|W|stopped. Tell your doctor right away if you develop: diarrhea||
0416|019|W|that doesn't stop, abdominal or stomach pain/cramping,||
0416|020|W|blood/mucus in your stool.||
0416|021|W|   If you have these symptoms, do not use anti-diarrhea or opioid||
0416|022|W|products because they may make symptoms worse. Consult your||
0416|023|W|doctor or pharmacist for details and an appropriate treatment||
0416|024|W|plan.||
0416|025|B|||
0416|026|U|USES:  Clindamycin is used to treat a wide variety of serious||
0416|027|U|bacterial infections. It is an antibiotic that works by stopping||
0416|028|U|the growth of bacteria.||
0416|029|U|   This antibiotic only treats bacterial infections. It will not||
0416|030|U|work for viral infections (such as common cold, flu). Unnecessary||
0416|031|U|use or overuse of any antibiotic can lead to its decreased||
0416|032|U|effectiveness.||
0416|033|B|||
0416|034|H|HOW TO USE:  Take this medication by mouth with or without food||
0416|035|H|as directed by your doctor, usually 3 or 4 times a day.||
0416|036|H|   Shake the bottle well before each dose. Carefully measure the||
0416|037|H|dose using a special measuring device/spoon. Do not use a||
0416|038|H|household spoon because you may not get the correct dose.||
0416|039|H|   For the best effect, take this antibiotic at evenly spaced||
0416|040|H|times. To help you remember, take this medication at the same||
0416|041|H|time(s) every day.||
0416|042|H|   Continue to take this medication until the full prescribed||
0416|043|H|amount is finished, even if symptoms disappear after a few days.||
0416|044|H|Stopping the medication too early may result in a return of the||
0416|045|H|infection.||
0416|046|H|   Tell your doctor if your condition lasts or gets worse.||
0416|047|B|||
0416|048|S|SIDE EFFECTS:  See also the Warning section.||
0416|049|S|   Nausea, vomiting, upset stomach, or mild diarrhea may occur.||
0416|050|S|If any of these effects last or get worse, notify your doctor or||
0416|051|S|pharmacist promptly.||
0416|052|S|   Remember that this medication has been prescribed because your||
0416|053|S|doctor has judged that the benefit to you is greater than the||
0416|054|S|risk of side effects. Many people using this medication do not||
0416|055|S|have serious side effects.||
0416|056|S|   Tell your doctor right away if you have any serious side||
0416|057|S|effects, including: sore/painful throat, joint pain/swelling,||
0416|058|S|yellowing eyes/skin, signs of kidney problems (such as change in||
0416|059|S|the amount of urine).||
0416|060|S|   Use of this medication for prolonged or repeated periods may||
0416|061|S|result in oral thrush or a new vaginal yeast infection (oral or||
0416|062|S|vaginal fungal infection). Contact your doctor if you notice||
0416|063|S|white patches in your mouth, a change in vaginal discharge, or||
0416|064|S|other new symptoms.||
0416|065|S|   A very serious allergic reaction to this drug is rare.||
0416|066|S|However, get medical help right away if you notice any symptoms||
0416|067|S|of a serious allergic reaction, including: fever that doesn't go||
0416|068|S|away, new or worsening lymph node swelling, rash,||
0416|069|S|itching/swelling (especially of the face/tongue/throat), severe||
0416|070|S|dizziness, trouble breathing.||
0416|071|S|   This is not a complete list of possible side effects. If you||
0416|072|S|notice other effects not listed above, contact your doctor or||
0416|073|S|pharmacist.||
0416|074|S|   In the US -||
0416|075|S|   Call your doctor for medical advice about side effects. You||
0416|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0416|077|S|www.fda.gov/medwatch.||
0416|078|S|   In Canada - Call your doctor for medical advice about side||
0416|079|S|effects. You may report side effects to Health Canada at||
0416|080|S|1-866-234-2345.||
0416|081|B|||
0416|082|P|PRECAUTIONS:  Before taking clindamycin, tell your doctor or||
0416|083|P|pharmacist if you are allergic to it; or to lincomycin; or if you||
0416|084|P|have any other allergies. This product may contain inactive||
0416|085|P|ingredients, which can cause allergic reactions or other||
0416|086|P|problems. Talk to your pharmacist for more details.||
0416|087|P|   Before using this medication, tell your doctor or pharmacist||
0416|088|P|your medical history, especially of: liver disease, kidney||
0416|089|P|disease, intestinal diseases (such as enteritis, ulcerative||
0416|090|P|colitis, C. difficile-associated diarrhea), chronic asthma or hay||
0416|091|P|fever (atopic conditions).||
0416|092|P|   Clindamycin may cause live bacterial vaccines (such as typhoid||
0416|093|P|vaccine) to not work well. Tell your health care professional||
0416|094|P|that you are using clindamycin before having any||
0416|095|P|immunizations/vaccinations.||
0416|096|P|   Before having surgery, tell your doctor or dentist about all||
0416|097|P|the products you use (including prescription drugs,||
0416|098|P|nonprescription drugs, and herbal products).||
0416|099|P|   Older adults may be more sensitive to the side effects of this||
0416|100|P|drug, especially diarrhea.||
0416|101|P|   Tell your doctor if you are pregnant before using this||
0416|102|P|medication.||
0416|103|P|   This medication passes into breast milk. Consult your doctor||
0416|104|P|before breastfeeding.||
0416|105|B|||
0416|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0416|107|I|medications work or increase your risk for serious side effects.||
0416|108|I|This document does not contain all possible drug interactions.||
0416|109|I|Keep a list of all the products you use (including||
0416|110|I|prescription/nonprescription drugs and herbal products) and share||
0416|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0416|112|I|the dosage of any medicines without your doctor's approval.||
0416|113|I|   A product that may interact with this drug is: kaolin-pectin.||
0416|114|B|||
0416|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0416|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0416|117|O|poison control center right away. US residents can call||
0416|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0416|119|B|||
0416|120|N|NOTES:  Do not share this medication with others.||
0416|121|N|   This medication has been prescribed for your current condition||
0416|122|N|only. Do not use it later for another infection unless your||
0416|123|N|doctor tells you to.||
0416|124|N|   With prolonged use, lab and/or medical tests (such as||
0416|125|N|kidney/liver function, blood counts) should be done while you are||
0416|126|N|taking this medication. Consult your doctor for more details.||
0416|127|B|||
0416|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0416|129|D|If it is near the time of the next dose, skip the missed dose.||
0416|130|D|Use your next dose at the regular time. Do not double the dose to||
0416|131|D|catch up.||
0416|132|B|||
0416|133|R|STORAGE:  Store at room temperature. Discard any unused||
0416|134|R|medication after 14 days. Keep all medications away from children||
0416|135|R|and pets.||
0416|136|R|   Do not flush medications down the toilet or pour them into a||
0416|137|R|drain unless instructed to do so. Properly discard this product||
0416|138|R|when it is expired or no longer needed. Consult your pharmacist||
0416|139|R|or local waste disposal company.||
0416|140|B|||
0416|141|A|Information last revised May 2025.||
0416|142|A|Copyright(c) 2025 First Databank, Inc.||
0416|143|B|||
0417|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0417|002|Z|does NOT have all possible information about this product. This||
0417|003|Z|information does not assure that this product is safe, effective,||
0417|004|Z|or appropriate for you. This information is not individual||
0417|005|Z|medical advice and does not substitute for the advice of your||
0417|006|Z|health care professional. Always ask your health care||
0417|007|Z|professional for complete information about this product and your||
0417|008|Z|specific health needs.||
0417|009|B|||
0417|010|T|INTERFERON BETA-1A PREFILLED SYRINGE - INJECTION||
0417|011|F|(IN-ter-FEER-on BAY-ta-wun-ay)||
0417|012|B|||
0417|013|C|COMMON BRAND NAME(S): Avonex||
0417|014|B|||
0417|015|U|USES:  This medication is used to treat multiple sclerosis (MS).||
0417|016|U|Interferon is not a cure for MS, but it may help to slow disease||
0417|017|U|worsening and decrease flare-ups of symptoms (such as balance||
0417|018|U|problems, numbness, or weakness).||
0417|019|B|||
0417|020|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
0417|021|H|provided by your pharmacist before you start using interferon||
0417|022|H|beta-1A and each time you get a refill. Ask your health care||
0417|023|H|professional how to prepare and use this medication. If you have||
0417|024|H|any questions, ask your doctor or pharmacist.||
0417|025|H|   Inject this medication into a muscle as directed by your||
0417|026|H|doctor, usually once a week. Depending on your product, the||
0417|027|H|injection is given in the thigh or upper arm. It is best to use||
0417|028|H|this medication near bedtime to reduce side effects. The dosage||
0417|029|H|is based on your medical condition and response to treatment. To||
0417|030|H|reduce your risk of side effects, your doctor may direct you to||
0417|031|H|start this medication at a low dose and gradually increase your||
0417|032|H|dose. Follow your doctor's instructions carefully.||
0417|033|H|   For a more comfortable injection, take the medication out of||
0417|034|H|the refrigerator at least 30 minutes before you inject it to||
0417|035|H|allow it to reach room temperature. Do not warm up this||
0417|036|H|medication any other way (for example, do not heat it in the||
0417|037|H|microwave or place it in hot water). Before using, check this||
0417|038|H|product for particles or discoloration. If either is present, do||
0417|039|H|not use the liquid. Before injecting each dose, clean the skin||
0417|040|H|you are going to inject into (the injection site) with rubbing||
0417|041|H|alcohol. Change the injection site each time to lessen injury. Do||
0417|042|H|not inject into skin that is red, sore, scarred, or infected.||
0417|043|H|Tell your doctor of any skin reactions that do not go away after||
0417|044|H|a few days. Learn how to store and discard medical supplies||
0417|045|H|safely.||
0417|046|H|   Use this medication regularly to get the most benefit from it.||
0417|047|H|To help you remember, use it on the same day each week.||
0417|048|H|   Tell your doctor if your condition gets worse.||
0417|049|B|||
0417|050|S|SIDE EFFECTS:  Pain, swelling, or redness at the injection site||
0417|051|S|may occur. If any of these effects last or get worse, tell your||
0417|052|S|doctor or pharmacist promptly.||
0417|053|S|   Most people have flu-like symptoms such as headache,||
0417|054|S|tiredness, fever, chills, and muscle aches when they first start||
0417|055|S|this medication. These symptoms usually last about 1 day after||
0417|056|S|the injection and improve or go away after a few months of||
0417|057|S|continued use. You can lessen these side effects by injecting||
0417|058|S|this medicine at bedtime and by using fever reducers/pain||
0417|059|S|relievers such as acetaminophen or ibuprofen before each dose.||
0417|060|S|Ask your doctor or pharmacist for more information.||
0417|061|S|   Remember that this medication has been prescribed because your||
0417|062|S|doctor has judged that the benefit to you is greater than the||
0417|063|S|risk of side effects. Many people using this medication do not||
0417|064|S|have serious side effects.||
0417|065|S|   Tell your doctor right away if you have any serious side||
0417|066|S|effects, including: mental/mood changes (such as new or worsening||
0417|067|S|depression, thoughts of suicide, psychosis), feeling too hot or||
0417|068|S|cold (more than others around you), blue fingers/toes, easy||
0417|069|S|bleeding/bruising, pus or change in skin color at the injection||
0417|070|S|site, joint pain/swelling, signs of kidney problems (such as a||
0417|071|S|change in the amount of urine), signs of liver problems (such as||
0417|072|S|nausea/vomiting that doesn't stop, loss of appetite,||
0417|073|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), new or||
0417|074|S|worsening symptoms of heart failure (such as shortness of breath,||
0417|075|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
0417|076|S|gain).||
0417|077|S|   Get medical help right away if you have any very serious side||
0417|078|S|effects, including: seizures.||
0417|079|S|   This medication may lower your ability to fight infections.||
0417|080|S|This may make you more likely to get a serious (rarely fatal)||
0417|081|S|infection or make any infection you have worse. Tell your doctor||
0417|082|S|right away if you have any signs of infections (such as sore||
0417|083|S|throat that doesn't go away, fever, chills).||
0417|084|S|   A very serious allergic reaction to this drug is rare.||
0417|085|S|However, get medical help right away if you notice any symptoms||
0417|086|S|of a serious allergic reaction, including: rash, itching/swelling||
0417|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0417|088|S|breathing.||
0417|089|S|   This is not a complete list of possible side effects. If you||
0417|090|S|notice other effects not listed above, contact your doctor or||
0417|091|S|pharmacist.||
0417|092|S|   In the US -||
0417|093|S|   Call your doctor for medical advice about side effects. You||
0417|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0417|095|S|www.fda.gov/medwatch.||
0417|096|S|   In Canada - Call your doctor for medical advice about side||
0417|097|S|effects. You may report side effects to Health Canada at||
0417|098|S|1-866-234-2345.||
0417|099|B|||
0417|100|P|PRECAUTIONS:  Before using interferon, tell your doctor or||
0417|101|P|pharmacist if you are allergic to it; or if you have any other||
0417|102|P|allergies. This product may contain inactive ingredients (such as||
0417|103|P|natural rubber/latex), which can cause allergic reactions or||
0417|104|P|other problems. Talk to your pharmacist for more details.||
0417|105|P|   Before using this medication, tell your doctor or pharmacist||
0417|106|P|your medical history, especially of: bleeding/blood problems,||
0417|107|P|heart problems (such as heart failure, angina, fast/irregular||
0417|108|P|heartbeat), liver disease, mental/mood disorders (such as||
0417|109|P|depression, psychosis, suicidal thoughts), seizure disorder,||
0417|110|P|thyroid disease.||
0417|111|P|   Interferon can make you more likely to get infections or may||
0417|112|P|make current infections worse. Stay away from anyone who has an||
0417|113|P|infection that may easily spread (such as chickenpox, COVID-19,||
0417|114|P|measles, flu). Talk to your doctor if you have been exposed to an||
0417|115|P|infection or for more details.||
0417|116|P|   Tell your health care professional that you are using||
0417|117|P|interferon before having any immunizations/vaccinations. Avoid||
0417|118|P|contact with people who have recently received live vaccines||
0417|119|P|(such as flu vaccine inhaled through the nose).||
0417|120|P|   Before having surgery, tell your doctor or dentist about all||
0417|121|P|the products you use (including prescription drugs,||
0417|122|P|nonprescription drugs, and herbal products).||
0417|123|P|   During pregnancy, this medication should be used only when||
0417|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
0417|125|P|   This medication passes into breast milk in small amounts, but||
0417|126|P|is unlikely to harm a nursing infant. Consult your doctor before||
0417|127|P|breastfeeding.||
0417|128|B|||
0417|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0417|130|I|medications work or increase your risk for serious side effects.||
0417|131|I|This document does not contain all possible drug interactions.||
0417|132|I|Keep a list of all the products you use (including||
0417|133|I|prescription/nonprescription drugs and herbal products) and share||
0417|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
0417|135|I|the dosage of any medicines without your doctor's approval.||
0417|136|B|||
0417|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0417|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0417|139|O|poison control center right away. US residents can call||
0417|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0417|141|B|||
0417|142|N|NOTES:  Do not share this medication with others.||
0417|143|N|   Lab and/or medical tests (such as complete blood count,||
0417|144|N|liver/thyroid function) should be done while you are using this||
0417|145|N|medication. Keep all medical and lab appointments.||
0417|146|B|||
0417|147|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0417|148|D|Do not use this medication 2 days in a row. Do not double the||
0417|149|D|dose to catch up. Follow your usual schedule the next week.||
0417|150|B|||
0417|151|R|STORAGE:  Store in the refrigerator away from light. Do not||
0417|152|R|freeze. This medication may also be stored at room temperature if||
0417|153|R|needed. If the medication is stored at room temperature, discard||
0417|154|R|after 7 days. Keep all medications away from children and pets.||
0417|155|R|   Do not flush medications down the toilet or pour them into a||
0417|156|R|drain unless instructed to do so. Properly discard this product||
0417|157|R|when it is expired or no longer needed. Consult your pharmacist||
0417|158|R|or local waste disposal company.||
0417|159|B|||
0417|160|A|Information last revised April 2025.||
0417|161|A|Copyright(c) 2025 First Databank, Inc.||
0417|162|B|||
0419|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0419|002|Z|does NOT have all possible information about this product. This||
0419|003|Z|information does not assure that this product is safe, effective,||
0419|004|Z|or appropriate for you. This information is not individual||
0419|005|Z|medical advice and does not substitute for the advice of your||
0419|006|Z|health care professional. Always ask your health care||
0419|007|Z|professional for complete information about this product and your||
0419|008|Z|specific health needs.||
0419|009|B|||
0419|010|T|METHYLPREDNISOLONE - ORAL||
0419|011|F|(METH-il-pred-NIS-oh-lone)||
0419|012|B|||
0419|013|C|COMMON BRAND NAME(S): Medrol||
0419|014|B|||
0419|015|U|USES:  Methylprednisolone is used to treat conditions such as||
0419|016|U|arthritis, blood disorders, severe allergic reactions, certain||
0419|017|U|cancers, eye conditions, skin/kidney/intestinal/lung diseases,||
0419|018|U|and immune system disorders. It decreases your immune system's||
0419|019|U|response to various diseases to reduce symptoms such as swelling,||
0419|020|U|pain, and allergic-type reactions. This medication is a||
0419|021|U|corticosteroid hormone.||
0419|022|U|   Methylprednisolone may also be used with other medications in||
0419|023|U|hormone disorders.||
0419|024|B|||
0419|025|V|OTHER USES:  This section contains uses of this drug that are not||
0419|026|V|listed in the approved professional labeling for the drug but||
0419|027|V|that may be prescribed by your health care professional. Use this||
0419|028|V|drug for a condition that is listed in this section only if it||
0419|029|V|has been so prescribed by your health care professional.||
0419|030|V|   Methylprednisolone may also be used for COVID-19, but is only||
0419|031|V|effective in hospitalized patients who need supplemental oxygen||
0419|032|V|or a mechanical ventilator to breathe.||
0419|033|B|||
0419|034|H|HOW TO USE:  Take this medication by mouth as directed by your||
0419|035|H|doctor, usually with food or milk. Follow your dosing||
0419|036|H|instructions carefully. The dosage and length of treatment are||
0419|037|H|based on your medical condition and response to treatment.||
0419|038|H|Different dosing schedules exist for this medication. If you are||
0419|039|H|not taking the same dose each day or if you take this medication||
0419|040|H|every other day, it may help to mark your calendar with a||
0419|041|H|reminder. Consult your doctor or pharmacist if you have any||
0419|042|H|questions.||
0419|043|H|   Do not increase your dose or use this drug more often or for||
0419|044|H|longer than prescribed. Your condition will not improve any||
0419|045|H|faster, and your risk of side effects will increase.||
0419|046|H|   Do not stop taking this medication without consulting your||
0419|047|H|doctor. Some conditions may become worse when this drug is||
0419|048|H|suddenly stopped. Your dose may need to be gradually decreased.||
0419|049|H|   If you suddenly stop using this medication, you may have||
0419|050|H|withdrawal symptoms (such as weakness, weight loss, nausea,||
0419|051|H|muscle pain, headache, tiredness, dizziness). To help prevent||
0419|052|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0419|053|H|more likely if you have used methylprednisolone for a long time||
0419|054|H|or in high doses. Tell your doctor or pharmacist right away if||
0419|055|H|you have withdrawal. See also Precautions section.||
0419|056|H|   Tell your doctor if your condition does not get better or if||
0419|057|H|it gets worse.||
0419|058|B|||
0419|059|S|SIDE EFFECTS:  Nausea, vomiting, heartburn, headache, dizziness,||
0419|060|S|trouble sleeping, appetite changes, increased sweating, or acne||
0419|061|S|may occur. If any of these effects last or get worse, tell your||
0419|062|S|doctor or pharmacist promptly.||
0419|063|S|   Remember that this medication has been prescribed because your||
0419|064|S|doctor has judged that the benefit to you is greater than the||
0419|065|S|risk of side effects. Many people using this medication do not||
0419|066|S|have serious side effects.||
0419|067|S|   This medication may make your blood sugar rise, which can||
0419|068|S|cause or worsen diabetes. Tell your doctor right away if you have||
0419|069|S|symptoms of high blood sugar such as increased thirst/urination.||
0419|070|S|If you already have diabetes, check your blood sugar regularly as||
0419|071|S|directed and share the results with your doctor. Your doctor may||
0419|072|S|need to adjust your diabetes medication, exercise program, or||
0419|073|S|diet.||
0419|074|S|   This medication may lower your ability to fight infections.||
0419|075|S|This may make you more likely to get a serious (rarely fatal)||
0419|076|S|infection or make any infection you have worse. Tell your doctor||
0419|077|S|right away if you have any signs of infection (such as sore||
0419|078|S|throat that doesn't go away, fever, chills, white patches in the||
0419|079|S|mouth).||
0419|080|S|   Tell your doctor right away if you have any serious side||
0419|081|S|effects, including: unusual weight gain, menstrual period||
0419|082|S|changes, bone/joint pain, easy bruising/bleeding, mental/mood||
0419|083|S|changes (such as mood swings, depression, agitation), muscle||
0419|084|S|weakness/pain, puffy face, slow wound healing, swelling of the||
0419|085|S|ankles/feet/hands, thinning skin, unusual hair/skin growth,||
0419|086|S|vision problems, fast/slow/irregular heartbeat, symptoms of||
0419|087|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
0419|088|S|black/tarry stools, vomit that looks like coffee grounds),||
0419|089|S|red/purple spots on the skin.||
0419|090|S|   Get medical help right away if you have any very serious side||
0419|091|S|effects, including: seizures.||
0419|092|S|   A very serious allergic reaction to this drug is rare.||
0419|093|S|However, get medical help right away if you notice any symptoms||
0419|094|S|of a serious allergic reaction, including: rash, itching/swelling||
0419|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0419|096|S|breathing.||
0419|097|S|   This is not a complete list of possible side effects. If you||
0419|098|S|notice other effects not listed above, contact your doctor or||
0419|099|S|pharmacist.||
0419|100|S|   In the US -||
0419|101|S|   Call your doctor for medical advice about side effects. You||
0419|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0419|103|S|www.fda.gov/medwatch.||
0419|104|S|   In Canada - Call your doctor for medical advice about side||
0419|105|S|effects. You may report side effects to Health Canada at||
0419|106|S|1-866-234-2345.||
0419|107|B|||
0419|108|P|PRECAUTIONS:  Before taking methylprednisolone, tell your doctor||
0419|109|P|or pharmacist if you are allergic to it; or to prednisone; or if||
0419|110|P|you have any other allergies. This product may contain inactive||
0419|111|P|ingredients, which can cause allergic reactions or other||
0419|112|P|problems. Talk to your pharmacist for more details.||
0419|113|P|   Before using this medication, tell your doctor or pharmacist||
0419|114|P|your medical history, especially of: bleeding problems, blood||
0419|115|P|clots, brittle bones (osteoporosis), diabetes, eye diseases (such||
0419|116|P|as cataracts, glaucoma, herpes infection of the eye), heart||
0419|117|P|problems (such as recent heart attack, heart failure), high blood||
0419|118|P|pressure, current/past infections (such as those caused by||
0419|119|P|tuberculosis, threadworm, herpes, fungus), kidney disease, liver||
0419|120|P|disease (such as hepatitis B), mental/mood conditions (such as||
0419|121|P|psychosis, depression, anxiety), stomach/intestinal problems||
0419|122|P|(such as diverticulitis, ulcer, ulcerative colitis), seizures, a||
0419|123|P|certain adrenal gland tumor (pheochromocytoma).||
0419|124|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0419|125|P|can make you more dizzy. Do not drive, use machinery, or do||
0419|126|P|anything that needs alertness until you can do it safely. Talk to||
0419|127|P|your doctor if you are using marijuana (cannabis).||
0419|128|P|   This medication may cause stomach bleeding. Daily use of||
0419|129|P|alcohol while using this medication may increase your risk for||
0419|130|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
0419|131|P|or pharmacist for more information.||
0419|132|P|   Methylprednisolone can make you more likely to get infections||
0419|133|P|or may make current infections worse. Stay away from anyone who||
0419|134|P|has an infection that may easily spread (such as chickenpox,||
0419|135|P|COVID-19, measles, flu). Talk to your doctor if you have been||
0419|136|P|exposed to an infection or for more details.||
0419|137|P|   Tell your health care professional that you are using||
0419|138|P|methylprednisolone before having any immunizations, vaccinations,||
0419|139|P|or skin tests. Avoid contact with people who have recently||
0419|140|P|received live vaccines (such as flu vaccine inhaled through the||
0419|141|P|nose).||
0419|142|P|   Before having surgery, tell your doctor or dentist about all||
0419|143|P|the products you use (including prescription drugs,||
0419|144|P|nonprescription drugs, and herbal products).||
0419|145|P|   Using corticosteroid medications for a long time can make it||
0419|146|P|more difficult for your body to respond to physical stress.||
0419|147|P|Before having surgery or emergency treatment, or if you get a||
0419|148|P|serious illness/injury, tell your doctor or dentist that you are||
0419|149|P|using this medication or have used this medication within the||
0419|150|P|past 12 months. Tell your doctor right away if you develop||
0419|151|P|unusual/extreme tiredness or weight loss. If you will be using||
0419|152|P|this medication for a long time, carry a warning card or medical||
0419|153|P|ID bracelet that identifies your use of this medication. See also||
0419|154|P|Medical Alert section.||
0419|155|P|   Older adults may be more sensitive to the side effects of this||
0419|156|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
0419|157|P|mental/mood changes (such as confusion).||
0419|158|P|   This medication may slow down a child's growth if used for a||
0419|159|P|long time. Consult the doctor or pharmacist for more details. See||
0419|160|P|the doctor regularly so your child's height and growth can be||
0419|161|P|checked.||
0419|162|P|   During pregnancy, this medication should be used only when||
0419|163|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
0419|164|P|risks and benefits with your doctor. Infants born to mothers who||
0419|165|P|have been using this medication for a long time may have hormone||
0419|166|P|problems. Tell your doctor right away if you notice symptoms such||
0419|167|P|as nausea/vomiting that doesn't stop, severe diarrhea, or||
0419|168|P|weakness in your newborn.||
0419|169|P|   This medication passes into breast milk, but is unlikely to||
0419|170|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0419|171|B|||
0419|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0419|173|I|medications work or increase your risk for serious side effects.||
0419|174|I|This document does not contain all possible drug interactions.||
0419|175|I|Keep a list of all the products you use (including||
0419|176|I|prescription/nonprescription drugs and herbal products) and share||
0419|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
0419|178|I|the dosage of any medicines without your doctor's approval.||
0419|179|I|   Some products that may interact with this drug include:||
0419|180|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
0419|181|I|also cause bleeding/bruising (including antiplatelet drugs such||
0419|182|I|as clopidogrel, "blood thinners" such as warfarin/dabigatran,||
0419|183|I|NSAIDs such as ibuprofen, celecoxib, aspirin, salicylates).||
0419|184|I|   If your doctor has told you to take low-dose aspirin to||
0419|185|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0419|186|I|you should keep taking the aspirin unless your doctor tells you||
0419|187|I|not to. Ask your doctor or pharmacist for more details.||
0419|188|I|   Other medications can affect the removal of methylprednisolone||
0419|189|I|from your body, which may affect how methylprednisolone works.||
0419|190|I|Examples include azole antifungals (such as ketoconazole),||
0419|191|I|cyclosporine, estrogens, HIV protease inhibitors (such as||
0419|192|I|darunavir), macrolide antibiotics (such as erythromycin),||
0419|193|I|ritonavir, St. John's wort, some drugs used to treat seizures||
0419|194|I|(such as phenytoin, phenobarbital), among others.||
0419|195|I|   This medication may interfere with certain lab tests (such as||
0419|196|I|skin tests), possibly causing false test results. Make sure lab||
0419|197|I|personnel and all your doctors know you use this drug.||
0419|198|B|||
0419|199|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0419|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0419|201|O|poison control center right away. US residents can call||
0419|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0419|203|B|||
0419|204|N|NOTES:  Do not share this medication with others.||
0419|205|N|   If this medication is used for a long time, lab and/or medical||
0419|206|N|tests (such as blood sugar/mineral levels, blood pressure, eye||
0419|207|N|exams, bone density tests, height/weight measurements) should be||
0419|208|N|done while you are taking this medication. Keep all medical and||
0419|209|N|lab appointments. Consult your doctor for more details.||
0419|210|N|   This medication may cause bone loss (osteoporosis) when used||
0419|211|N|for a long time. Lifestyle changes that may help reduce the risk||
0419|212|N|of bone problems include doing weight-bearing exercise, stopping||
0419|213|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
0419|214|N|D. Talk to your doctor for more details.||
0419|215|B|||
0419|216|D|MISSED DOSE:  If you are taking this medication once daily and||
0419|217|D|miss a dose, take it as soon as you remember. If it is near the||
0419|218|D|time of the next dose, skip the missed dose. Take your next dose||
0419|219|D|at the regular time. Do not double the dose to catch up.||
0419|220|D|   If you do not take the same dose each day or if you take this||
0419|221|D|medication every other day, ask your doctor or pharmacist what||
0419|222|D|you should do if you miss a dose.||
0419|223|B|||
0419|224|R|STORAGE:  Store at room temperature away from light and moisture.||
0419|225|R|Do not store in the bathroom. Keep all medications away from||
0419|226|R|children and pets.||
0419|227|R|   Do not flush medications down the toilet or pour them into a||
0419|228|R|drain unless instructed to do so. Properly discard this product||
0419|229|R|when it is expired or no longer needed. Consult your pharmacist||
0419|230|R|or local waste disposal company.||
0419|231|B|||
0419|232|M|MEDICAL ALERT:  Your condition can cause complications in a||
0419|233|M|medical emergency. For information about enrolling in MedicAlert,||
0419|234|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0419|235|B|||
0419|236|A|Information last revised September 2025.||
0419|237|A|Copyright(c) 2025 First Databank, Inc.||
0419|238|B|||
0420|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0420|002|Z|does NOT have all possible information about this product. This||
0420|003|Z|information does not assure that this product is safe, effective,||
0420|004|Z|or appropriate for you. This information is not individual||
0420|005|Z|medical advice and does not substitute for the advice of your||
0420|006|Z|health care professional. Always ask your health care||
0420|007|Z|professional for complete information about this product and your||
0420|008|Z|specific health needs.||
0420|009|B|||
0420|010|T|DESONIDE CREAM/GEL/OINTMENT - TOPICAL||
0420|011|F|(DES-oh-nide)||
0420|012|B|||
0420|013|C|COMMON BRAND NAME(S): Desonate, Desowen, Tridesilon||
0420|014|B|||
0420|015|U|USES:  This medication is used to treat a variety of skin||
0420|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0420|017|U|Desonide reduces the swelling, itching and redness that can occur||
0420|018|U|in these types of conditions. Desonide is a mild corticosteroid.||
0420|019|B|||
0420|020|H|HOW TO USE:  Use this medication only on the skin.||
0420|021|H|   Wash your hands. Before applying the medication, clean and dry||
0420|022|H|the affected area. Apply a thin film of the medication to the||
0420|023|H|affected area and gently rub in as directed by your doctor,||
0420|024|H|usually 2 to 3 times daily. If using the gel, apply the gel||
0420|025|H|usually only 2 times daily. Do not bandage, wrap, or cover the||
0420|026|H|area unless you are instructed to do so by your doctor. If used||
0420|027|H|in the diaper area on an infant, do not use tight-fitting diapers||
0420|028|H|or plastic pants.||
0420|029|H|   After applying the medication, wash and dry your hands, unless||
0420|030|H|you are using this medication to treat the hands. When applying||
0420|031|H|this medication near the eyes, avoid getting it in the eyes||
0420|032|H|because this may worsen or cause glaucoma, or cause irritation.||
0420|033|H|Also, avoid getting this medication in the nose or mouth. If you||
0420|034|H|get this medication in your eyes, nose, or mouth, rinse right||
0420|035|H|away with plenty of water.||
0420|036|H|   Use this medication only for the condition prescribed.||
0420|037|H|   Tell your doctor if your condition lasts or gets worse after 2||
0420|038|H|weeks.||
0420|039|B|||
0420|040|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
0420|041|S|or redness may occur when first applied to the skin. This should||
0420|042|S|disappear in a few days as your body adjusts to the medication.||
0420|043|S|If any of these effects last or get worse, tell your doctor or||
0420|044|S|pharmacist promptly.||
0420|045|S|   Remember that this medication has been prescribed because your||
0420|046|S|doctor has judged that the benefit to you is greater than the||
0420|047|S|risk of side effects. Many people using this medication do not||
0420|048|S|have serious side effects.||
0420|049|S|   Tell your doctor right away if you have any serious side||
0420|050|S|effects, including: stretch marks, skin thinning/discoloration,||
0420|051|S|acne, excessive hair growth, small red bumps on the skin||
0420|052|S|(folliculitis).||
0420|053|S|   Skin infections can become worse when using this medication.||
0420|054|S|Tell your doctor promptly if redness, swelling or irritation does||
0420|055|S|not improve.||
0420|056|S|   A very serious allergic reaction to this drug is rare.||
0420|057|S|However, get medical help right away if you notice any symptoms||
0420|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0420|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0420|060|S|breathing.||
0420|061|S|   This is not a complete list of possible side effects. If you||
0420|062|S|notice other effects not listed above, contact your doctor or||
0420|063|S|pharmacist.||
0420|064|S|   In the US -||
0420|065|S|   Call your doctor for medical advice about side effects. You||
0420|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0420|067|S|www.fda.gov/medwatch.||
0420|068|S|   In Canada - Call your doctor for medical advice about side||
0420|069|S|effects. You may report side effects to Health Canada at||
0420|070|S|1-866-234-2345.||
0420|071|B|||
0420|072|P|PRECAUTIONS:  Before using desonide, tell your doctor or||
0420|073|P|pharmacist if you are allergic to it; or to other corticosteroids||
0420|074|P|(such as hydrocortisone, prednisone); or if you have any other||
0420|075|P|allergies. This product may contain inactive ingredients, which||
0420|076|P|can cause allergic reactions or other problems. Talk to your||
0420|077|P|pharmacist for more details.||
0420|078|P|   Before using this medication, tell your doctor or pharmacist||
0420|079|P|your medical history, especially of: poor blood circulation,||
0420|080|P|diabetes, immune system problems, other skin conditions (such as||
0420|081|P|rosacea, perioral dermatitis).||
0420|082|P|   Do not use if there is an infection or sore in the area to be||
0420|083|P|treated.||
0420|084|P|   Before having surgery, tell your doctor or dentist about all||
0420|085|P|the products you use (including prescription drugs,||
0420|086|P|nonprescription drugs, and herbal products).||
0420|087|P|   Children may be more sensitive to the effects of too much||
0420|088|P|corticosteroid medication. Consult your doctor for more details.||
0420|089|P|   During pregnancy, this medication should be used only when||
0420|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
0420|091|P|   It is unknown if this medication, when applied to the skin,||
0420|092|P|passes into breast milk. However, similar drugs, when taken by||
0420|093|P|mouth, pass into breast milk. Consult your doctor before||
0420|094|P|breastfeeding.||
0420|095|B|||
0420|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0420|097|I|medications work or increase your risk for serious side effects.||
0420|098|I|This document does not contain all possible drug interactions.||
0420|099|I|Keep a list of all the products you use (including||
0420|100|I|prescription/nonprescription drugs and herbal products) and share||
0420|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0420|102|I|the dosage of any medicines without your doctor's approval.||
0420|103|B|||
0420|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0420|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0420|106|O|poison control center right away. US residents can call||
0420|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0420|108|O|medication may be harmful if swallowed.||
0420|109|B|||
0420|110|N|NOTES:  Do not share this medication with others.||
0420|111|N|   This medication has been prescribed for your current condition||
0420|112|N|only. Do not use it later for other skin problems unless told to||
0420|113|N|do so by your doctor. A different medication may be necessary in||
0420|114|N|those cases.||
0420|115|N|   Tell all your doctors you use or have used this medication.||
0420|116|B|||
0420|117|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0420|118|D|If it is near the time of the next dose, skip the missed dose.||
0420|119|D|Use your next dose at the regular time. Do not double the dose to||
0420|120|D|catch up.||
0420|121|B|||
0420|122|R|STORAGE:  Different brands/strengths of this medication may have||
0420|123|R|different storage requirements. Read the package labeling or ask||
0420|124|R|your pharmacist for the storage requirements for the product you||
0420|125|R|are using. Store at room temperature. Keep all medications away||
0420|126|R|from children and pets.||
0420|127|R|   Do not flush medications down the toilet or pour them into a||
0420|128|R|drain unless instructed to do so. Properly discard this product||
0420|129|R|when it is expired or no longer needed. Consult your pharmacist||
0420|130|R|or local waste disposal company.||
0420|131|B|||
0420|132|A|Information last revised October 2024.||
0420|133|A|Copyright(c) 2025 First Databank, Inc.||
0420|134|B|||
0421|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0421|002|Z|does NOT have all possible information about this product. This||
0421|003|Z|information does not assure that this product is safe, effective,||
0421|004|Z|or appropriate for you. This information is not individual||
0421|005|Z|medical advice and does not substitute for the advice of your||
0421|006|Z|health care professional. Always ask your health care||
0421|007|Z|professional for complete information about this product and your||
0421|008|Z|specific health needs.||
0421|009|B|||
0421|010|T|DESONIDE LOTION - TOPICAL||
0421|011|F|(DES-oh-nide)||
0421|012|B|||
0421|013|C|COMMON BRAND NAME(S): Desowen||
0421|014|B|||
0421|015|U|USES:  This medication is used to treat a variety of skin||
0421|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0421|017|U|Desonide reduces the swelling, itching and redness that can occur||
0421|018|U|in these types of conditions. Desonide is a mild corticosteroid.||
0421|019|B|||
0421|020|H|HOW TO USE:  Use this medication only on the skin.||
0421|021|H|   Shake the bottle well before using. Wash your hands. Clean and||
0421|022|H|dry the affected area. Apply a thin film of medication to the||
0421|023|H|affected area and gently rub in as directed by your doctor,||
0421|024|H|usually 2 to 3 times daily. Do not bandage, wrap, or cover the||
0421|025|H|area unless you are instructed to do so by your doctor. If used||
0421|026|H|in the diaper area on an infant, do not use tight-fitting diapers||
0421|027|H|or plastic pants.||
0421|028|H|   After applying the medication, wash and dry your hands, unless||
0421|029|H|you are using this medication to treat the hands. When applying||
0421|030|H|this medication near the eyes, avoid getting it in the eyes||
0421|031|H|because this may worsen or cause glaucoma or cause irritation.||
0421|032|H|Also, avoid getting this medication in the nose or mouth. If you||
0421|033|H|get this medication in your eyes, nose, or mouth, rinse right||
0421|034|H|away with plenty of water.||
0421|035|H|   Use this medication only for the condition prescribed.||
0421|036|H|   Tell your doctor if your condition lasts or gets worse after 2||
0421|037|H|weeks.||
0421|038|B|||
0421|039|S|SIDE EFFECTS:  Burning, stinging, itching, irritation, dryness,||
0421|040|S|or redness may occur when first applied to the skin. This should||
0421|041|S|disappear in a few days as your body adjusts to the medication.||
0421|042|S|If any of these effects last or get worse, tell your doctor or||
0421|043|S|pharmacist promptly.||
0421|044|S|   Remember that this medication has been prescribed because your||
0421|045|S|doctor has judged that the benefit to you is greater than the||
0421|046|S|risk of side effects. Many people using this medication do not||
0421|047|S|have serious side effects.||
0421|048|S|   Tell your doctor right away if you have any serious side||
0421|049|S|effects, including: stretch marks, skin thinning/discoloration,||
0421|050|S|acne, excessive hair growth, small red bumps on the skin||
0421|051|S|(folliculitis).||
0421|052|S|   Skin infections can become worse when using this medication.||
0421|053|S|Tell your doctor promptly if redness, swelling or irritation does||
0421|054|S|not improve.||
0421|055|S|   A very serious allergic reaction to this drug is rare.||
0421|056|S|However, get medical help right away if you notice any symptoms||
0421|057|S|of a serious allergic reaction, including: rash, itching/swelling||
0421|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0421|059|S|breathing.||
0421|060|S|   This is not a complete list of possible side effects. If you||
0421|061|S|notice other effects not listed above, contact your doctor or||
0421|062|S|pharmacist.||
0421|063|S|   In the US -||
0421|064|S|   Call your doctor for medical advice about side effects. You||
0421|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0421|066|S|www.fda.gov/medwatch.||
0421|067|S|   In Canada - Call your doctor for medical advice about side||
0421|068|S|effects. You may report side effects to Health Canada at||
0421|069|S|1-866-234-2345.||
0421|070|B|||
0421|071|P|PRECAUTIONS:  Before using desonide, tell your doctor or||
0421|072|P|pharmacist if you are allergic to it; or to other corticosteroids||
0421|073|P|(such as hydrocortisone, prednisone); or if you have any other||
0421|074|P|allergies. This product may contain inactive ingredients, which||
0421|075|P|can cause allergic reactions or other problems. Talk to your||
0421|076|P|pharmacist for more details.||
0421|077|P|   Before using this medication, tell your doctor or pharmacist||
0421|078|P|your medical history, especially of: poor blood circulation,||
0421|079|P|diabetes, immune system problems, other skin conditions (such as||
0421|080|P|rosacea, perioral dermatitis).||
0421|081|P|   Do not use if there is an infection or sore in the area to be||
0421|082|P|treated.||
0421|083|P|   Before having surgery, tell your doctor or dentist about all||
0421|084|P|the products you use (including prescription drugs,||
0421|085|P|nonprescription drugs, and herbal products).||
0421|086|P|   Children may be more sensitive to the effects of too much||
0421|087|P|corticosteroid medication. Consult your doctor for more details.||
0421|088|P|   During pregnancy, this medication should be used only when||
0421|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
0421|090|P|   It is unknown if this medication, when applied to the skin,||
0421|091|P|passes into breast milk. However, similar drugs, when taken by||
0421|092|P|mouth, pass into breast milk. Consult your doctor before||
0421|093|P|breastfeeding.||
0421|094|B|||
0421|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0421|096|I|medications work or increase your risk for serious side effects.||
0421|097|I|This document does not contain all possible drug interactions.||
0421|098|I|Keep a list of all the products you use (including||
0421|099|I|prescription/nonprescription drugs and herbal products) and share||
0421|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
0421|101|I|the dosage of any medicines without your doctor's approval.||
0421|102|B|||
0421|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0421|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0421|105|O|poison control center right away. US residents can call||
0421|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0421|107|O|medication may be harmful if swallowed.||
0421|108|B|||
0421|109|N|NOTES:  Do not share this medication with others. This medication||
0421|110|N|has been prescribed for your current condition only. Do not use||
0421|111|N|it later for other skin problems unless told to do so by your||
0421|112|N|doctor. A different medication may be necessary in those cases.||
0421|113|N|   Inform all your doctors you use or have used this medication.||
0421|114|B|||
0421|115|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0421|116|D|If it is near the time of the next dose, skip the missed dose.||
0421|117|D|Use your next dose at the regular time. Do not double the dose to||
0421|118|D|catch up.||
0421|119|B|||
0421|120|R|STORAGE:  Store at room temperature. Keep all medications away||
0421|121|R|from children and pets.||
0421|122|R|   Do not flush medications down the toilet or pour them into a||
0421|123|R|drain unless instructed to do so. Properly discard this product||
0421|124|R|when it is expired or no longer needed. Consult your pharmacist||
0421|125|R|or local waste disposal company.||
0421|126|B|||
0421|127|A|Information last revised October 2024.||
0421|128|A|Copyright(c) 2025 First Databank, Inc.||
0421|129|B|||
0422|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0422|002|Z|does NOT have all possible information about this product. This||
0422|003|Z|information does not assure that this product is safe, effective,||
0422|004|Z|or appropriate for you. This information is not individual||
0422|005|Z|medical advice and does not substitute for the advice of your||
0422|006|Z|health care professional. Always ask your health care||
0422|007|Z|professional for complete information about this product and your||
0422|008|Z|specific health needs.||
0422|009|B|||
0422|010|T|DIMENHYDRINATE - ORAL||
0422|011|F|(DYE-men-HYE-dri-nate)||
0422|012|B|||
0422|013|C|COMMON BRAND NAME(S): Dramamine||
0422|014|B|||
0422|015|U|USES:  Dimenhydrinate is an antihistamine used to prevent and||
0422|016|U|treat nausea, vomiting, and dizziness caused by motion sickness.||
0422|017|U|   Do not use this medication in children younger than two years||
0422|018|U|unless directed by the doctor.||
0422|019|B|||
0422|020|V|OTHER USES:  This section contains uses of this drug that are not||
0422|021|V|listed in the approved professional labeling for the drug but||
0422|022|V|that may be prescribed by your health care professional. Use this||
0422|023|V|drug for a condition that is listed in this section only if it||
0422|024|V|has been so prescribed by your health care professional.||
0422|025|V|   This drug may also be used for nausea and dizziness caused by||
0422|026|V|inner ear problems (such as Meniere's disease).||
0422|027|B|||
0422|028|H|HOW TO USE:  Follow all directions on the product package. If||
0422|029|H|your doctor has prescribed this medication, take it as directed.||
0422|030|H|If you have any questions, ask your doctor or pharmacist.||
0422|031|H|   Take this medication by mouth with or without food. Measure||
0422|032|H|liquid forms of this medication using a special measuring||
0422|033|H|device/spoon. Do not use a household spoon because you may not||
0422|034|H|get the correct dose. The chewable tablets should be chewed||
0422|035|H|thoroughly before being swallowed.||
0422|036|H|   The dosage is based on your age, medical condition, and||
0422|037|H|response to treatment. Do not increase your dose or take this||
0422|038|H|medication more often than directed.||
0422|039|H|   To prevent motion sickness, take the first dose 30 to 60||
0422|040|H|minutes before starting activity such as travel.||
0422|041|H|   Tell your doctor if your condition does not get better or if||
0422|042|H|it gets worse.||
0422|043|B|||
0422|044|S|SIDE EFFECTS:  Drowsiness, constipation, blurred vision, or dry||
0422|045|S|mouth/nose/throat may occur. If any of these effects last or get||
0422|046|S|worse, tell your doctor or pharmacist promptly.||
0422|047|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0422|048|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0422|049|S|substitute.||
0422|050|S|   If your doctor has directed you to use this medication,||
0422|051|S|remember that your doctor has judged that the benefit to you is||
0422|052|S|greater than the risk of side effects. Many people using this||
0422|053|S|medication do not have serious side effects.||
0422|054|S|   Tell your doctor right away if you have any serious side||
0422|055|S|effects, including: mental/mood changes (such as restlessness,||
0422|056|S|confusion), fast/irregular heartbeat, shaking (tremor),||
0422|057|S|difficulty urinating.||
0422|058|S|   Get medical help right away if you have any very serious side||
0422|059|S|effects, including: seizures.||
0422|060|S|   A very serious allergic reaction to this drug is rare.||
0422|061|S|However, get medical help right away if you notice any symptoms||
0422|062|S|of a serious allergic reaction, including: rash, itching/swelling||
0422|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0422|064|S|breathing.||
0422|065|S|   This is not a complete list of possible side effects. If you||
0422|066|S|notice other effects not listed above, contact your doctor or||
0422|067|S|pharmacist.||
0422|068|S|   In the US -||
0422|069|S|   Call your doctor for medical advice about side effects. You||
0422|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0422|071|S|www.fda.gov/medwatch.||
0422|072|S|   In Canada - Call your doctor for medical advice about side||
0422|073|S|effects. You may report side effects to Health Canada at||
0422|074|S|1-866-234-2345.||
0422|075|B|||
0422|076|P|PRECAUTIONS:  Before taking dimenhydrinate, tell your doctor or||
0422|077|P|pharmacist if you are allergic to it; or to diphenhydramine; or||
0422|078|P|if you have any other allergies. This product may contain||
0422|079|P|inactive ingredients, which can cause allergic reactions or other||
0422|080|P|problems. Talk to your pharmacist for more details.||
0422|081|P|   Before using this medication, tell your doctor or pharmacist||
0422|082|P|your medical history, especially of: breathing problems (such as||
0422|083|P|asthma, emphysema), high pressure in the eye (glaucoma), heart||
0422|084|P|problems, high blood pressure, liver disease, seizures,||
0422|085|P|stomach/intestine problems (such as ulcers, blockage), overactive||
0422|086|P|thyroid (hyperthyroidism), difficulty urinating (for example, due||
0422|087|P|to enlarged prostate).||
0422|088|P|   This drug may make you drowsy or blur your vision. Alcohol or||
0422|089|P|marijuana (cannabis) can make you more drowsy. Do not drive, use||
0422|090|P|machinery, or do anything that needs alertness or clear vision||
0422|091|P|until you can do it safely. Avoid alcoholic beverages. Talk to||
0422|092|P|your doctor if you are using marijuana (cannabis).||
0422|093|P|   Before having surgery, tell your doctor or dentist about all||
0422|094|P|the products you use (including prescription drugs,||
0422|095|P|nonprescription drugs, and herbal products).||
0422|096|P|   Liquid products or chewable tablets may contain sugar and/or||
0422|097|P|aspartame. Caution is advised if you have diabetes,||
0422|098|P|phenylketonuria (PKU), or any other condition that requires you||
0422|099|P|to limit/avoid these substances in your diet. Ask your doctor or||
0422|100|P|pharmacist about using this product safely.||
0422|101|P|   Children may be more sensitive to the side effects of this||
0422|102|P|drug. This drug can often cause excitement in young children||
0422|103|P|instead of drowsiness.||
0422|104|P|   Older adults may be more sensitive to the side effects of this||
0422|105|P|drug, especially drowsiness, confusion, constipation, or trouble||
0422|106|P|urinating. Drowsiness and confusion can increase the risk of||
0422|107|P|falling.||
0422|108|P|   During pregnancy, this medication should be used only when||
0422|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
0422|110|P|   This drug passes into breast milk and may have undesirable||
0422|111|P|effects on a nursing infant. Consult your doctor before||
0422|112|P|breastfeeding.||
0422|113|B|||
0422|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0422|115|I|medications work or increase your risk for serious side effects.||
0422|116|I|This document does not contain all possible drug interactions.||
0422|117|I|Keep a list of all the products you use (including||
0422|118|I|prescription/nonprescription drugs and herbal products) and share||
0422|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
0422|120|I|the dosage of any medicines without your doctor's approval.||
0422|121|I|   Some products that may interact with this drug include:||
0422|122|I|antihistamines applied to the skin (such as diphenhydramine||
0422|123|I|cream, ointment, spray).||
0422|124|I|   Tell your doctor or pharmacist if you are taking other||
0422|125|I|products that cause drowsiness such as opioid pain or cough||
0422|126|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0422|127|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0422|128|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0422|129|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0422|130|I|diphenhydramine).||
0422|131|I|   Check the labels on all your medicines (such as allergy or||
0422|132|I|cough-and-cold products) because they may contain ingredients||
0422|133|I|that cause drowsiness. Ask your pharmacist about using those||
0422|134|I|products safely.||
0422|135|I|   This medication may interfere with certain lab tests (such as||
0422|136|I|allergy skin test), possibly causing false test results. Make||
0422|137|I|sure lab personnel and all your doctors know you use this drug.||
0422|138|B|||
0422|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0422|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0422|141|O|poison control center right away. US residents can call||
0422|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0422|143|O|Symptoms of overdose may include: severe drowsiness, seizures,||
0422|144|O|widened pupils. In children, mental/mood changes (such as||
0422|145|O|restlessness, irritability, hallucinations) may occur before||
0422|146|O|drowsiness.||
0422|147|B|||
0422|148|N|NOTES:  Keep all medical and lab appointments.||
0422|149|B|||
0422|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0422|151|D|remember. If it is near the time of your next dose, skip the||
0422|152|D|missed dose. Take your next dose at the regular time. Do not||
0422|153|D|double the dose to catch up.||
0422|154|B|||
0422|155|R|STORAGE:  Store at room temperature away from moisture and light.||
0422|156|R|Do not store in the bathroom. Do not freeze liquid forms of this||
0422|157|R|medication. Keep all medications away from children and pets.||
0422|158|R|   Do not flush medications down the toilet or pour them into a||
0422|159|R|drain unless instructed to do so. Properly discard this product||
0422|160|R|when it is expired or no longer needed. Consult your pharmacist||
0422|161|R|or local waste disposal company.||
0422|162|B|||
0422|163|A|Information last revised October 2024.||
0422|164|A|Copyright(c) 2025 First Databank, Inc.||
0422|165|B|||
0423|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0423|002|Z|does NOT have all possible information about this product. This||
0423|003|Z|information does not assure that this product is safe, effective,||
0423|004|Z|or appropriate for you. This information is not individual||
0423|005|Z|medical advice and does not substitute for the advice of your||
0423|006|Z|health care professional. Always ask your health care||
0423|007|Z|professional for complete information about this product and your||
0423|008|Z|specific health needs.||
0423|009|B|||
0423|010|T|DIMENHYDRINATE - INJECTION||
0423|011|F|(DYE-men-HYE-dri-nate)||
0423|012|B|||
0423|013|C|COMMON BRAND NAME(S): Dramamine||
0423|014|B|||
0423|015|U|USES:  Dimenhydrinate is an antihistamine used to prevent and||
0423|016|U|treat nausea, vomiting and dizziness caused by motion sickness||
0423|017|U|when medication cannot be given by mouth.||
0423|018|U|   Dimenhydrinate injection should not be used in newborns||
0423|019|U|because of an increased risk of side effects.||
0423|020|B|||
0423|021|V|OTHER USES:  This section contains uses of this drug that are not||
0423|022|V|listed in the approved professional labeling for the drug but||
0423|023|V|that may be prescribed by your health care professional. Use this||
0423|024|V|drug for a condition that is listed in this section only if it||
0423|025|V|has been so prescribed by your health care professional.||
0423|026|V|   This drug may also be used for symptoms of other motion and||
0423|027|V|balance problems such as feelings of dizziness/spinning (vertigo)||
0423|028|V|and inner ear problems (such as Meniere's disease). It may also||
0423|029|V|be used for nausea and vomiting due to surgery, radiation||
0423|030|V|sickness, side effects of drug treatment, and other causes.||
0423|031|B|||
0423|032|H|HOW TO USE:  This medication is injected into a vein (IV), or it||
0423|033|H|can be injected into a muscle by a health care professional, as||
0423|034|H|directed by your doctor. The dosage is based on your medical||
0423|035|H|condition and response to treatment.||
0423|036|H|   Tell your doctor if your condition lasts or gets worse.||
0423|037|B|||
0423|038|S|SIDE EFFECTS:  Drowsiness, constipation, blurred vision, or dry||
0423|039|S|mouth/nose/throat may occur. If any of these effects last or get||
0423|040|S|worse, tell your doctor or pharmacist promptly.||
0423|041|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0423|042|S|chips, chew (sugarless) gum, drink water or use a saliva||
0423|043|S|substitute.||
0423|044|S|   Remember that this medication has been prescribed because your||
0423|045|S|doctor has judged that the benefit to you is greater than the||
0423|046|S|risk of side effects. Many people using this medication do not||
0423|047|S|have serious side effects.||
0423|048|S|   Tell your doctor right away if you have any serious side||
0423|049|S|effects, including: mental/mood changes (such as restlessness,||
0423|050|S|confusion), fast/irregular heartbeat, shaking (tremor),||
0423|051|S|difficulty urinating.||
0423|052|S|   Get medical help right away if you have any very serious side||
0423|053|S|effects, including: seizures.||
0423|054|S|   A very serious allergic reaction to this drug is rare.||
0423|055|S|However, get medical help right away if you notice any symptoms||
0423|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0423|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0423|058|S|breathing.||
0423|059|S|   This is not a complete list of possible side effects. If you||
0423|060|S|notice other effects not listed above, contact your doctor or||
0423|061|S|pharmacist.||
0423|062|S|   In the US -||
0423|063|S|   Call your doctor for medical advice about side effects. You||
0423|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0423|065|S|www.fda.gov/medwatch.||
0423|066|S|   In Canada - Call your doctor for medical advice about side||
0423|067|S|effects. You may report side effects to Health Canada at||
0423|068|S|1-866-234-2345.||
0423|069|B|||
0423|070|P|PRECAUTIONS:  Before using dimenhydrinate, tell your doctor or||
0423|071|P|pharmacist if you are allergic to it; or to diphenhydramine; or||
0423|072|P|if you have any other allergies. This product may contain||
0423|073|P|inactive ingredients, which can cause allergic reactions or other||
0423|074|P|problems. Talk to your pharmacist for more details.||
0423|075|P|   Before using this medication, tell your doctor or pharmacist||
0423|076|P|your medical history, especially of: breathing problems (such as||
0423|077|P|asthma, emphysema), glaucoma, stomach problems (such as ulcers,||
0423|078|P|obstruction), difficulty urinating (for example, due to an||
0423|079|P|enlarged prostate gland), heart disease, high blood pressure,||
0423|080|P|liver disease, seizures, overactive thyroid.||
0423|081|P|   This drug may make you drowsy or blur your vision. Alcohol or||
0423|082|P|marijuana (cannabis) can make you more drowsy. Do not drive, use||
0423|083|P|machinery, or do anything that needs alertness or clear vision||
0423|084|P|until you can do it safely. Avoid alcoholic beverages. Talk to||
0423|085|P|your doctor if you are using marijuana (cannabis).||
0423|086|P|   Before having surgery, tell your doctor or dentist about all||
0423|087|P|the products you use (including prescription drugs,||
0423|088|P|nonprescription drugs, and herbal products).||
0423|089|P|   Children may be more sensitive to the side effects of this||
0423|090|P|drug. This drug can often cause excitement in young children||
0423|091|P|instead of drowsiness.||
0423|092|P|   Older adults may be more sensitive to the side effects of this||
0423|093|P|drug, especially drowsiness, confusion, constipation, or trouble||
0423|094|P|urinating. Drowsiness and confusion can increase the risk of||
0423|095|P|falling.||
0423|096|P|   During pregnancy, this medication should be used only when||
0423|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
0423|098|P|   This drug passes into breast milk and may have undesirable||
0423|099|P|effects on a nursing infant. Consult your doctor before||
0423|100|P|breastfeeding.||
0423|101|B|||
0423|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0423|103|I|medications work or increase your risk for serious side effects.||
0423|104|I|This document does not contain all possible drug interactions.||
0423|105|I|Keep a list of all the products you use (including||
0423|106|I|prescription/nonprescription drugs and herbal products) and share||
0423|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
0423|108|I|the dosage of any medicines without your doctor's approval.||
0423|109|I|   Some products that may interact with this drug include:||
0423|110|I|antihistamines applied to the skin (such as diphenhydramine||
0423|111|I|cream, ointment, spray).||
0423|112|I|   Tell your doctor or pharmacist if you are taking other||
0423|113|I|products that cause drowsiness such as opioid pain or cough||
0423|114|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0423|115|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0423|116|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0423|117|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0423|118|I|diphenhydramine).||
0423|119|I|   Check the labels on all your medicines (such as allergy or||
0423|120|I|cough-and-cold products) because they may contain ingredients||
0423|121|I|that cause drowsiness. Ask your pharmacist about using those||
0423|122|I|products safely.||
0423|123|I|   This medication may interfere with certain lab tests (such as||
0423|124|I|allergy skin test), possibly causing false test results. Make||
0423|125|I|sure lab personnel and all your doctors know you use this drug.||
0423|126|B|||
0423|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0423|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0423|129|O|poison control center right away. US residents can call||
0423|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0423|131|O|Symptoms of overdose may include: severe drowsiness, seizures,||
0423|132|O|widened pupils. In children, mental/mood changes (such as||
0423|133|O|restlessness, irritability, hallucinations) may occur before||
0423|134|O|drowsiness.||
0423|135|B|||
0423|136|N|NOTES:  Do not share this product with others.||
0423|137|B|||
0423|138|D|MISSED DOSE:  It is important to get each dose of this medication||
0423|139|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0423|140|D|right away for a new dosing schedule.||
0423|141|B|||
0423|142|R|STORAGE:  Not applicable. This medication is given in a hospital||
0423|143|R|or clinic and will not be stored at home.||
0423|144|B|||
0423|145|A|Information last revised June 2024.||
0423|146|A|Copyright(c) 2025 First Databank, Inc.||
0423|147|B|||
0424|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0424|002|Z|does NOT have all possible information about this product. This||
0424|003|Z|information does not assure that this product is safe, effective,||
0424|004|Z|or appropriate for you. This information is not individual||
0424|005|Z|medical advice and does not substitute for the advice of your||
0424|006|Z|health care professional. Always ask your health care||
0424|007|Z|professional for complete information about this product and your||
0424|008|Z|specific health needs.||
0424|009|B|||
0424|010|T|TRIFLUOPERAZINE - ORAL||
0424|011|F|(TRYE-floo-oh-PER-a-zeen)||
0424|012|B|||
0424|013|C|COMMON BRAND NAME(S): Stelazine||
0424|014|B|||
0424|015|W|WARNING:  There may be a slightly increased risk of serious,||
0424|016|W|possibly fatal side effects (such as heart failure,||
0424|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
0424|018|W|by older adults with dementia. This medication is not approved||
0424|019|W|for the treatment of dementia-related behavior problems. Discuss||
0424|020|W|the risks and benefits of this medication, as well as other||
0424|021|W|effective and possibly safer treatments for dementia-related||
0424|022|W|behavior problems, with the doctor.||
0424|023|B|||
0424|024|U|USES:  This medication is used to treat certain mental/mood||
0424|025|U|disorders (such as schizophrenia, psychotic disorders).||
0424|026|U|Trifluoperazine belongs to a class of drugs known as||
0424|027|U|antipsychotics. It works by helping to restore the balance of||
0424|028|U|certain natural substances in the brain.||
0424|029|B|||
0424|030|H|HOW TO USE:  Take this medication by mouth with or without food||
0424|031|H|as directed by your doctor, usually once or twice daily.||
0424|032|H|   The dosage is based on your medical condition, age, and||
0424|033|H|response to treatment. IChildren's dosage is also based on||
0424|034|H|weight. To reduce your risk of side effects, your doctor may||
0424|035|H|direct you to start this medication at a low dose and gradually||
0424|036|H|increase your dose. Follow your doctor's instructions carefully.||
0424|037|H|   Take this medication regularly to get the most benefit from||
0424|038|H|it. To help you remember, take it at the same time(s) each day.||
0424|039|H|   Although you may notice some medication effects soon after||
0424|040|H|starting, it may take 2 to 3 weeks before you get the full||
0424|041|H|benefit of this drug.||
0424|042|H|   Do not stop taking this medication without consulting your||
0424|043|H|doctor. Some conditions may become worse when this drug is||
0424|044|H|suddenly stopped. Also, you may experience symptoms such as upset||
0424|045|H|stomach, nausea, vomiting, dizziness, and shakiness. To prevent||
0424|046|H|these symptoms while you are stopping treatment with this drug,||
0424|047|H|your doctor may reduce your dose gradually. Consult your doctor||
0424|048|H|or pharmacist for more details. Report any new or worsening||
0424|049|H|symptoms right away.||
0424|050|H|   Tell your doctor if your condition does not get better or if||
0424|051|H|it gets worse.||
0424|052|B|||
0424|053|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, dry mouth,||
0424|054|S|blurred vision, tiredness, constipation, weight gain, and trouble||
0424|055|S|sleeping may occur. If any of these effects last or get worse,||
0424|056|S|tell your doctor or pharmacist promptly.||
0424|057|S|   Dizziness and lightheadedness can increase the risk of||
0424|058|S|falling. Get up slowly when rising from a sitting or lying||
0424|059|S|position.||
0424|060|S|   Tell your doctor right away if any of these side effects||
0424|061|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
0424|062|S|mask-like expression of the face, drooling/trouble swallowing, or||
0424|063|S|shuffling walk. Your doctor may prescribe another medication to||
0424|064|S|decrease these side effects.||
0424|065|S|   Remember that this medication has been prescribed because your||
0424|066|S|doctor has judged that the benefit to you is greater than the||
0424|067|S|risk of side effects. Many people using this medication do not||
0424|068|S|have serious side effects.||
0424|069|S|   Tell your doctor right away if you have any serious side||
0424|070|S|effects, including: difficulty urinating, decreased cough reflex,||
0424|071|S|swelling of the feet/ankles, butterfly-shaped rash on nose and||
0424|072|S|cheeks, joint pain, skin discoloration, eye/vision changes,||
0424|073|S|feeling unusually cold or hot, signs of liver problems (such as||
0424|074|S|nausea that doesn't stop, yellowing eyes/skin, vomiting,||
0424|075|S|stomach/abdominal pain), signs of infection (such as sore throat||
0424|076|S|that doesn't go away, fever, chills), easy bruising/bleeding,||
0424|077|S|signs of anemia (such as severe tiredness, fast breathing, pale||
0424|078|S|skin, fast heartbeat), mental/mood changes (such as worsening||
0424|079|S|psychosis, unresponsive/catatonic state).||
0424|080|S|   Rarely, this medication may cause face/muscle twitching and||
0424|081|S|uncontrollable movements (tardive dyskinesia). In some cases,||
0424|082|S|this condition may be permanent. Tell your doctor right away if||
0424|083|S|you develop any uncontrollable movements such as lip smacking,||
0424|084|S|mouth puckering, tongue thrusting, chewing, or unusual arm/leg||
0424|085|S|movements.||
0424|086|S|   In rare cases, trifluoperazine may increase your level of a||
0424|087|S|certain chemical made by the body (prolactin). For females, this||
0424|088|S|increase in prolactin may result in unwanted breast milk,||
0424|089|S|missed/stopped periods, or difficulty becoming pregnant. For||
0424|090|S|males, it may result in decreased sexual ability, inability to||
0424|091|S|produce sperm, or enlarged breasts. If you develop any of these||
0424|092|S|symptoms, tell your doctor right away.||
0424|093|S|   Rarely, males may have a painful or prolonged erection lasting||
0424|094|S|4 or more hours. If this occurs, stop using this drug and get||
0424|095|S|medical help right away, or permanent problems could occur.||
0424|096|S|   Get medical help right away if you have any very serious side||
0424|097|S|effects, including: slowed breathing, chest pain, seizures.||
0424|098|S|   This medication may rarely cause a very serious condition||
0424|099|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0424|100|S|right away if you have any of the following symptoms: fever,||
0424|101|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
0424|102|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
0424|103|S|signs of kidney problems (such as change in the amount of urine).||
0424|104|S|   A very serious allergic reaction to this drug is rare.||
0424|105|S|However, get medical help right away if you notice any symptoms||
0424|106|S|of a serious allergic reaction, including: rash, itching/swelling||
0424|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0424|108|S|breathing.||
0424|109|S|   This is not a complete list of possible side effects. If you||
0424|110|S|notice other effects not listed above, contact your doctor or||
0424|111|S|pharmacist.||
0424|112|S|   In the US -||
0424|113|S|   Call your doctor for medical advice about side effects. You||
0424|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0424|115|S|www.fda.gov/medwatch.||
0424|116|S|   In Canada - Call your doctor for medical advice about side||
0424|117|S|effects. You may report side effects to Health Canada at||
0424|118|S|1-866-234-2345.||
0424|119|B|||
0424|120|P|PRECAUTIONS:  Before taking trifluoperazine, tell your doctor or||
0424|121|P|pharmacist if you are allergic to it; or to other phenothiazines||
0424|122|P|(such as chlorpromazine, perphenazine); or if you have any other||
0424|123|P|allergies. This product may contain inactive ingredients, which||
0424|124|P|can cause allergic reactions or other problems. Talk to your||
0424|125|P|pharmacist for more details.||
0424|126|P|   Before using this medication, tell your doctor or pharmacist||
0424|127|P|your medical history, especially of: liver problems, kidney||
0424|128|P|problems, heart problems (such as mitral valve insufficiency,||
0424|129|P|abnormal heart rhythm, angina), low blood pressure, blockage of||
0424|130|P|the intestines, glaucoma, seizures, enlarged prostate, breathing||
0424|131|P|problems (such as severe asthma, emphysema, lung infections),||
0424|132|P|blood disorders (such as bone marrow depression, low||
0424|133|P|red/white/platelet blood cell counts), low levels of calcium in||
0424|134|P|the blood, dehydration, breast cancer, brain||
0424|135|P|disorder/tumor/injury, exposure to organophosphate insecticides,||
0424|136|P|a certain adrenal gland tumor (pheochromocytoma),||
0424|137|P|drug/alcohol/substance abuse, Parkinson's disease.||
0424|138|P|   This drug may make you dizzy or drowsy or blur your vision.||
0424|139|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0424|140|P|drowsy. Do not drive, use machinery, or do anything that needs||
0424|141|P|alertness or clear vision until you can do it safely. Avoid||
0424|142|P|alcoholic beverages. Talk to your doctor if you are using||
0424|143|P|marijuana (cannabis).||
0424|144|P|   Before having surgery or imaging procedures (such as certain||
0424|145|P|X-rays, CT scans) requiring the use of contrast dye (such as||
0424|146|P|metrizamide), tell your doctor or dentist that you are using this||
0424|147|P|medication and about all the products you use (including||
0424|148|P|prescription drugs, nonprescription drugs, and herbal products).||
0424|149|P|   This medication may make you more sensitive to the sun. Limit||
0424|150|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0424|151|P|sunscreen and wear protective clothing when outdoors. Tell your||
0424|152|P|doctor right away if you get sunburned or have skin||
0424|153|P|blisters/redness.||
0424|154|P|   This medication may make you sweat less, making you more||
0424|155|P|likely to get heat stroke. Avoid doing things that may cause you||
0424|156|P|to overheat, such as hard work or exercise in hot weather, or||
0424|157|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0424|158|P|and dress lightly. If you overheat, quickly look for a place to||
0424|159|P|cool down and rest. Get medical help right away if you have a||
0424|160|P|fever that does not go away, mental/mood changes, headache, or||
0424|161|P|dizziness.||
0424|162|P|   Children may be more sensitive to the side effects of this||
0424|163|P|drug, especially uncontrolled movements. They may be at greater||
0424|164|P|risk when they are sick (such as having viral infection,||
0424|165|P|dehydration).||
0424|166|P|   Older adults may be more sensitive to the side effects of this||
0424|167|P|drug, especially dizziness, lightheadedness, drowsiness,||
0424|168|P|confusion, uncontrollable movements, constipation, difficulty||
0424|169|P|urinating, or blurred vision. Dizziness, lightheadedness,||
0424|170|P|drowsiness, and confusion can increase the risk of falling.||
0424|171|P|   During pregnancy, this medication should be used only when||
0424|172|P|clearly needed. Babies born to mothers who have used this drug||
0424|173|P|during the last 3 months of pregnancy may rarely develop symptoms||
0424|174|P|including muscle stiffness or shakiness, drowsiness,||
0424|175|P|feeding/breathing difficulties, or constant crying. If you notice||
0424|176|P|any of these symptoms in your newborn especially during their||
0424|177|P|first month, tell the doctor right away.||
0424|178|P|   Since untreated mental/mood problems (such as schizophrenia,||
0424|179|P|psychotic disorders) can be a serious condition, do not stop||
0424|180|P|taking this medication unless directed by your doctor. If you are||
0424|181|P|planning pregnancy, become pregnant, or think you may be||
0424|182|P|pregnant, immediately discuss with your doctor the benefits and||
0424|183|P|risks of using this medication during pregnancy.||
0424|184|P|   This medication passes into breast milk. Consult your doctor||
0424|185|P|before breastfeeding.||
0424|186|B|||
0424|187|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0424|188|I|medications work or increase your risk for serious side effects.||
0424|189|I|This document does not contain all possible drug interactions.||
0424|190|I|Keep a list of all the products you use (including||
0424|191|I|prescription/nonprescription drugs and herbal products) and share||
0424|192|I|it with your doctor and pharmacist. Do not start, stop, or change||
0424|193|I|the dosage of any medicines without your doctor's approval.||
0424|194|I|   Some products that may interact with this drug include:||
0424|195|I|guanethidine, lithium, phenytoin, warfarin.||
0424|196|I|   Tell your doctor or pharmacist if you are taking other||
0424|197|I|products that cause drowsiness or may slow your breathing||
0424|198|I|including alcohol, marijuana (cannabis), antihistamines (such as||
0424|199|I|cetirizine, diphenhydramine), drugs for sleep or anxiety (such as||
0424|200|I|alprazolam, diazepam, zolpidem), muscle relaxants, and opioid||
0424|201|I|pain relievers (such as codeine).||
0424|202|I|   Check the labels on all your medicines (such as allergy or||
0424|203|I|cough-and-cold products) because they may contain ingredients||
0424|204|I|that cause drowsiness. Ask your pharmacist about using those||
0424|205|I|products safely.||
0424|206|I|   This medication may interfere with certain lab tests (such as||
0424|207|I|phenylketonuria tests), possibly causing false test results. Make||
0424|208|I|sure lab personnel and all your doctors know you use this drug.||
0424|209|B|||
0424|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0424|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0424|212|O|poison control center right away. US residents can call||
0424|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0424|214|O|Symptoms of overdose may include: severe drowsiness/deep sleep,||
0424|215|O|loss of consciousness, agitation, restlessness, seizures,||
0424|216|O|irregular heartbeat.||
0424|217|B|||
0424|218|N|NOTES:  Do not share this medication with others.||
0424|219|N|   Lab and/or medical tests (such as liver function, blood||
0424|220|N|counts, eye exams) should be done while you are taking this||
0424|221|N|medication. Keep all medical and lab appointments. Consult your||
0424|222|N|doctor for more details.||
0424|223|B|||
0424|224|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0424|225|D|remember. If it is near the time of the next dose, skip the||
0424|226|D|missed dose. Take your next dose at the regular time. Do not||
0424|227|D|double the dose to catch up.||
0424|228|B|||
0424|229|R|STORAGE:  Store at room temperature away from light and moisture.||
0424|230|R|Do not store in the bathroom. Keep all medications away from||
0424|231|R|children and pets.||
0424|232|R|   Do not flush medications down the toilet or pour them into a||
0424|233|R|drain unless instructed to do so. Properly discard this product||
0424|234|R|when it is expired or no longer needed. Consult your pharmacist||
0424|235|R|or local waste disposal company.||
0424|236|B|||
0424|237|A|Information last revised April 2025.||
0424|238|A|Copyright(c) 2025 First Databank, Inc.||
0424|239|B|||
0425|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0425|002|Z|does NOT have all possible information about this product. This||
0425|003|Z|information does not assure that this product is safe, effective,||
0425|004|Z|or appropriate for you. This information is not individual||
0425|005|Z|medical advice and does not substitute for the advice of your||
0425|006|Z|health care professional. Always ask your health care||
0425|007|Z|professional for complete information about this product and your||
0425|008|Z|specific health needs.||
0425|009|B|||
0425|010|T|CINACALCET - ORAL||
0425|011|F|(SIN-a-KAL-set)||
0425|012|B|||
0425|013|C|COMMON BRAND NAME(S): Sensipar||
0425|014|B|||
0425|015|U|USES:  Cinacalcet is used to treat increased amounts of a certain||
0425|016|U|hormone (parathyroid) in people with long-term kidney disease who||
0425|017|U|are on dialysis. It is also used to treat increased amounts of||
0425|018|U|calcium in people with an overactive parathyroid gland or in||
0425|019|U|people with cancer of the parathyroid gland. Cinacalcet works by||
0425|020|U|decreasing the amount of parathyroid hormone, calcium, and||
0425|021|U|phosphorus in your body. Having the right amount of these||
0425|022|U|substances in your body helps to prevent bone disease.||
0425|023|B|||
0425|024|H|HOW TO USE:  Take this medication by mouth with food or shortly||
0425|025|H|after a meal, as directed by your doctor.||
0425|026|H|   The manufacturer directs not to split, chew, or crush the||
0425|027|H|tablet before taking it. However, many similar drugs||
0425|028|H|(immediate-release tablets) can be split, chewed, or crushed.||
0425|029|H|Follow your doctor's directions on how to take this medication.||
0425|030|H|   The dosage is based on your medical condition, response to||
0425|031|H|treatment, and lab tests.||
0425|032|H|   Take this medication regularly in order to get the most||
0425|033|H|benefit from it. Remember to take it at the same time(s) each||
0425|034|H|day.||
0425|035|B|||
0425|036|S|SIDE EFFECTS:  Nausea, vomiting, or unusual tiredness may occur.||
0425|037|S|If any of these effects last or get worse, tell your doctor or||
0425|038|S|pharmacist promptly.||
0425|039|S|   Remember that this medication has been prescribed because your||
0425|040|S|doctor has judged that the benefit to you is greater than the||
0425|041|S|risk of side effects. Many people using this medication do not||
0425|042|S|have serious side effects.||
0425|043|S|   Cinacalcet can cause low calcium blood levels. Your doctor||
0425|044|S|will check your calcium blood levels while you are taking this||
0425|045|S|medication. Tell your doctor right away if you have any of the||
0425|046|S|following symptoms of low calcium levels: numb/tingling skin,||
0425|047|S|severe muscle spasms, seizures, fast/irregular/pounding||
0425|048|S|heartbeat.||
0425|049|S|   Tell your doctor right away if you have any serious side||
0425|050|S|effects, including: black/bloody stools, stomach/abdominal pain,||
0425|051|S|vomit that contains blood or looks like coffee grounds.||
0425|052|S|   A very serious allergic reaction to this drug is rare.||
0425|053|S|However, get medical help right away if you notice any symptoms||
0425|054|S|of a serious allergic reaction, including: rash, itching/swelling||
0425|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0425|056|S|breathing.||
0425|057|S|   This is not a complete list of possible side effects. If you||
0425|058|S|notice other effects not listed above, contact your doctor or||
0425|059|S|pharmacist.||
0425|060|S|   In the US -||
0425|061|S|   Call your doctor for medical advice about side effects. You||
0425|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0425|063|S|www.fda.gov/medwatch.||
0425|064|S|   In Canada - Call your doctor for medical advice about side||
0425|065|S|effects. You may report side effects to Health Canada at||
0425|066|S|1-866-234-2345.||
0425|067|B|||
0425|068|P|PRECAUTIONS:  Before taking cinacalcet, tell your doctor or||
0425|069|P|pharmacist if you are allergic to it; or if you have any other||
0425|070|P|allergies. This product may contain inactive ingredients, which||
0425|071|P|can cause allergic reactions or other problems. Talk to your||
0425|072|P|pharmacist for more details.||
0425|073|P|   Before using this medication, tell your doctor or pharmacist||
0425|074|P|your medical history, especially of: low levels of calcium in the||
0425|075|P|blood (hypocalcemia), seizures, stomach/intestinal problems (such||
0425|076|P|as ulcers, gastritis, heartburn).||
0425|077|P|   Very low levels of calcium can affect the heart rhythm (QT||
0425|078|P|prolongation, ventricular arrhythmias). This risk may be||
0425|079|P|increased if you have certain conditions or are taking drugs that||
0425|080|P|can affect the heart rhythm. Before taking cinacalcet, tell your||
0425|081|P|doctor of all the drugs you take and if you have heart rhythm||
0425|082|P|problems or other heart problems (such as heart failure, low||
0425|083|P|blood pressure).||
0425|084|P|   Before having surgery, tell your doctor or dentist about all||
0425|085|P|the products you use (including prescription drugs,||
0425|086|P|nonprescription drugs, and herbal products).||
0425|087|P|   During pregnancy, this medication should be used only when||
0425|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
0425|089|P|   It is unknown if this medication passes into breast milk.||
0425|090|P|Consult your doctor before breastfeeding.||
0425|091|B|||
0425|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0425|093|I|medications work or increase your risk for serious side effects.||
0425|094|I|This document does not contain all possible drug interactions.||
0425|095|I|Keep a list of all the products you use (including||
0425|096|I|prescription/nonprescription drugs and herbal products) and share||
0425|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
0425|098|I|the dosage of any medicines without your doctor's approval.||
0425|099|I|   A product that may interact with this drug is: thioridazine.||
0425|100|I|   If your doctor tells you to switch from using this medication||
0425|101|I|to etelcalcetide, this medication should be stopped at least 7||
0425|102|I|days before starting etelcalcetide. Using both medications||
0425|103|I|together may increase the risk of side effects (especially low||
0425|104|I|calcium levels).||
0425|105|B|||
0425|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0425|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0425|108|O|poison control center right away. US residents can call||
0425|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0425|110|O|Symptoms of overdose may include: severe muscle spasms, seizures.||
0425|111|B|||
0425|112|N|NOTES:  Do not share this medication with others.||
0425|113|N|   Lab and/or medical tests (such as calcium, phosphorus,||
0425|114|N|parathyroid hormone levels) should be done while you are taking||
0425|115|N|this medication. Keep all medical and lab appointments. Consult||
0425|116|N|your doctor for more details.||
0425|117|B|||
0425|118|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0425|119|D|remember. If it is near the time of the next dose, skip the||
0425|120|D|missed dose. Take your next dose at the regular time. Do not||
0425|121|D|double the dose to catch up.||
0425|122|B|||
0425|123|R|STORAGE:  Store at room temperature away from light and moisture.||
0425|124|R|Do not store in the bathroom. Keep all medications away from||
0425|125|R|children and pets.||
0425|126|R|   Do not flush medications down the toilet or pour them into a||
0425|127|R|drain unless instructed to do so. Properly discard this product||
0425|128|R|when it is expired or no longer needed. Consult your pharmacist||
0425|129|R|or local waste disposal company.||
0425|130|B|||
0425|131|A|Information last revised May 2024.||
0425|132|A|Copyright(c) 2025 First Databank, Inc.||
0425|133|B|||
0426|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0426|002|Z|does NOT have all possible information about this product. This||
0426|003|Z|information does not assure that this product is safe, effective,||
0426|004|Z|or appropriate for you. This information is not individual||
0426|005|Z|medical advice and does not substitute for the advice of your||
0426|006|Z|health care professional. Always ask your health care||
0426|007|Z|professional for complete information about this product and your||
0426|008|Z|specific health needs.||
0426|009|B|||
0426|010|T|NEOMYCIN/POLYMYXIN B/GRAMICIDIN D SOLUTION - OPHTHALMIC||
0426|011|F|(NEE-oh-MYE-sin/POL-ee-MIX-in/GRAM-i-SYE-din)||
0426|012|B|||
0426|013|C|COMMON BRAND NAME(S): Neosporin||
0426|014|B|||
0426|015|U|USES:  This medication is used to treat eye infections. This||
0426|016|U|product contains 3 antibiotics that work together to stop the||
0426|017|U|growth of bacteria.||
0426|018|U|   This medication treats only bacterial eye infections. It will||
0426|019|U|not work for other types of eye infections. Unnecessary use or||
0426|020|U|overuse of any antibiotic can lead to its decreased||
0426|021|U|effectiveness.||
0426|022|B|||
0426|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0426|024|H|directed by your doctor, usually every 4 hours.||
0426|025|H|   To apply eye drops, wash your hands first. To avoid||
0426|026|H|contamination, do not touch the dropper tip or let it touch your||
0426|027|H|eye or any other surface.||
0426|028|H|   Do not wear contact lenses while you are using this medicine.||
0426|029|H|Sterilize contact lenses according to manufacturer's directions||
0426|030|H|and check with your doctor before using them.||
0426|031|H|   Tilt your head back, look upward and pull down the lower||
0426|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0426|033|H|and insert one drop. Look downward and gently close your eyes for||
0426|034|H|1 to 2 minutes. Place one finger at the corner of your eye (near||
0426|035|H|the nose) and apply gentle pressure. This will prevent the||
0426|036|H|medication from draining out. Try not to blink and do not rub||
0426|037|H|your eye. Repeat these steps for your other eye if so directed,||
0426|038|H|and if your dose is for more than 1 drop.||
0426|039|H|   Do not rinse the dropper. Replace the dropper cap after each||
0426|040|H|use.||
0426|041|H|   If you are using another kind of eye medication (such as drops||
0426|042|H|or ointments), wait at least 5 to 10 minutes before applying||
0426|043|H|other medications. Use eye drops before eye ointments to allow||
0426|044|H|the eye drops to enter the eye.||
0426|045|H|   Wait several minutes for your vision to clear before driving||
0426|046|H|or operating machinery.||
0426|047|H|   Use this medication regularly in order to get the most benefit||
0426|048|H|from it. To help you remember, use this medication at the same||
0426|049|H|times each day. Continue to use this medication for the full time||
0426|050|H|prescribed, even if symptoms disappear after a few days. Stopping||
0426|051|H|the medication too early may result in a return of the infection.||
0426|052|H|   Tell your doctor if your condition lasts or gets worse.||
0426|053|B|||
0426|054|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
0426|055|S|eyes for a minute or two when applied. Eye discomfort, redness,||
0426|056|S|or temporary blurred vision may also occur. If any of these||
0426|057|S|effects last or get worse, tell your doctor or pharmacist||
0426|058|S|promptly.||
0426|059|S|   Remember that this medication has been prescribed because your||
0426|060|S|doctor has judged that the benefit to you is greater than the||
0426|061|S|risk of side effects. Many people using this medication do not||
0426|062|S|have serious side effects.||
0426|063|S|   Use of this medication for prolonged or repeated periods may||
0426|064|S|result in a new fungal eye infection. Do not use it for longer||
0426|065|S|than prescribed. Contact your doctor if you notice new or||
0426|066|S|worsening symptoms.||
0426|067|S|   A very serious allergic reaction to this drug is rare.||
0426|068|S|However, get medical help right away if you notice any symptoms||
0426|069|S|of a serious allergic reaction, including: rash, itching/swelling||
0426|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0426|071|S|breathing.||
0426|072|S|   This is not a complete list of possible side effects. If you||
0426|073|S|notice other effects not listed above, contact your doctor or||
0426|074|S|pharmacist.||
0426|075|S|   In the US -||
0426|076|S|   Call your doctor for medical advice about side effects. You||
0426|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0426|078|S|www.fda.gov/medwatch.||
0426|079|S|   In Canada - Call your doctor for medical advice about side||
0426|080|S|effects. You may report side effects to Health Canada at||
0426|081|S|1-866-234-2345.||
0426|082|B|||
0426|083|P|PRECAUTIONS:  Before using neomycin/gramicidin/polymyxin, tell||
0426|084|P|your doctor or pharmacist if you are allergic to it; or to||
0426|085|P|kanamycin; or to gentamicin; or if you have any other allergies.||
0426|086|P|This product may contain inactive ingredients (such as||
0426|087|P|preservatives like thimerosal), which can cause allergic||
0426|088|P|reactions or other problems. Talk to your pharmacist for more||
0426|089|P|details.||
0426|090|P|   Before using this medication, tell your doctor or pharmacist||
0426|091|P|your medical history, especially of: other eye problems.||
0426|092|P|   After you apply this drug, your vision may become temporarily||
0426|093|P|blurred or unstable. Do not drive, use machinery, or do anything||
0426|094|P|that needs clear vision until you can do it safely.||
0426|095|P|   During pregnancy, this medication should be used only when||
0426|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
0426|097|P|   It is unknown if the medications in this product pass into||
0426|098|P|breast milk. Consult your doctor before breastfeeding.||
0426|099|B|||
0426|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0426|101|I|medications work or increase your risk for serious side effects.||
0426|102|I|This document does not contain all possible drug interactions.||
0426|103|I|Keep a list of all the products you use (including||
0426|104|I|prescription/nonprescription drugs and herbal products) and share||
0426|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
0426|106|I|the dosage of any medicines without your doctor's approval.||
0426|107|B|||
0426|108|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0426|109|O|has overdosed and has serious symptoms such as passing out or||
0426|110|O|trouble breathing, call 911. Otherwise, call a poison control||
0426|111|O|center right away. US residents can call 1-800-222-1222. Canada||
0426|112|O|residents can call 1-844-764-7669.||
0426|113|B|||
0426|114|N|NOTES:  Do not share this medication with others.||
0426|115|N|   This medication has been prescribed for your current condition||
0426|116|N|only. Throw away the unused medication after treatment is||
0426|117|N|completed. Do not use it later for another infection unless your||
0426|118|N|doctor tells you to.||
0426|119|B|||
0426|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0426|121|D|If it is near the time of the next dose, skip the missed dose.||
0426|122|D|Use your next dose at the regular time. Do not double the dose to||
0426|123|D|catch up.||
0426|124|B|||
0426|125|R|STORAGE:  Store at room temperature away from light. Discard the||
0426|126|R|solution if it turns brown or cloudy, or contains particles. Keep||
0426|127|R|all medications away from children and pets.||
0426|128|R|   Do not flush medications down the toilet or pour them into a||
0426|129|R|drain unless instructed to do so. Properly discard this product||
0426|130|R|when it is expired or no longer needed. Consult your pharmacist||
0426|131|R|or local waste disposal company.||
0426|132|B|||
0426|133|A|Information last revised October 2024.||
0426|134|A|Copyright(c) 2025 First Databank, Inc.||
0426|135|B|||
0427|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0427|002|Z|does NOT have all possible information about this product. This||
0427|003|Z|information does not assure that this product is safe, effective,||
0427|004|Z|or appropriate for you. This information is not individual||
0427|005|Z|medical advice and does not substitute for the advice of your||
0427|006|Z|health care professional. Always ask your health care||
0427|007|Z|professional for complete information about this product and your||
0427|008|Z|specific health needs.||
0427|009|B|||
0427|010|T|DICLOFENAC SOLUTION - TOPICAL||
0427|011|F|(dye-KLOE-fen-ak)||
0427|012|B|||
0427|013|C|COMMON BRAND NAME(S): Pennsaid||
0427|014|B|||
0427|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0427|016|W|diclofenac) may rarely increase the risk for a heart attack or||
0427|017|W|stroke. This effect can happen at any time while using this drug||
0427|018|W|but is more likely if you use it for a long time. The risk may be||
0427|019|W|greater in older adults or if you have heart disease or increased||
0427|020|W|risk for heart disease (for example, due to smoking, family||
0427|021|W|history of heart disease, or conditions such as high blood||
0427|022|W|pressure or diabetes). Do not use this drug right before or after||
0427|023|W|heart bypass surgery (CABG).||
0427|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0427|025|W|bleeding from the stomach or intestines. This side effect can||
0427|026|W|occur without warning symptoms at any time while using||
0427|027|W|diclofenac. Older adults may be at higher risk for this effect.||
0427|028|W|(See also Precautions and Drug Interactions sections.)||
0427|029|W|   Stop using diclofenac and get medical help right away if you||
0427|030|W|notice any of the following rare but very serious side effects:||
0427|031|W|stomach/abdominal pain that doesn't go away, black/bloody stools,||
0427|032|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0427|033|W|shortness of breath, unusual sweating, confusion, weakness on one||
0427|034|W|side of the body, sudden vision changes, trouble speaking.||
0427|035|W|   Talk with your doctor or pharmacist about the benefits and||
0427|036|W|risks of using this medication.||
0427|037|B|||
0427|038|U|USES:  See also Warning section.||
0427|039|U|   This medication is used to treat arthritis of the knee(s). It||
0427|040|U|reduces pain, swelling, and joint stiffness and helps to improve||
0427|041|U|your ability to move and flex the joint. Diclofenac is known as a||
0427|042|U|nonsteroidal anti-inflammatory drug (NSAID).||
0427|043|U|   If you are treating a chronic condition such as arthritis, ask||
0427|044|U|your doctor about non-drug treatments and/or using other||
0427|045|U|medications to treat your pain.||
0427|046|B|||
0427|047|H|HOW TO USE:  Read the Medication Guide if available, and the||
0427|048|H|Patient Information Leaflet provided by your pharmacist before||
0427|049|H|you start using diclofenac and each time you get a refill. If you||
0427|050|H|have any questions, ask your doctor or pharmacist.||
0427|051|H|   This medication is for use on the skin only. Apply this||
0427|052|H|medication to clean, dry skin, as directed by your doctor,||
0427|053|H|usually 2 or 4 times daily. The dosage is based on your medical||
0427|054|H|condition and response to treatment.||
0427|055|H|   If you are using the pump, read the Instructions for Use to||
0427|056|H|learn how to correctly prime the pump before using it for the||
0427|057|H|first time.||
0427|058|H|   Place this medication first into the hand or directly onto the||
0427|059|H|affected knee. Then spread the medication evenly around the||
0427|060|H|front, back, and sides of the knee. Repeat these steps until you||
0427|061|H|have applied the prescribed dose to cover all surfaces of the||
0427|062|H|knee. Repeat on the other knee if directed to do so by your||
0427|063|H|doctor. Let the medication dry for several minutes. Do not touch||
0427|064|H|the treated knee, allow other people to touch it, or wear||
0427|065|H|clothing over it until the treated knee is completely dry.||
0427|066|H|Consult your doctor or pharmacist if you have any questions on||
0427|067|H|how to use this medication.||
0427|068|H|   Be sure to wash your hands before and after applying the||
0427|069|H|medication. Avoid getting this medication in the eyes, nose, or||
0427|070|H|mouth. Do not apply this medication to open wounds, or to||
0427|071|H|infected or damaged skin. Do not bandage or tightly cover the||
0427|072|H|treated area unless you are instructed to do so by your doctor.||
0427|073|H|Wait at least 30 minutes after applying this medication before||
0427|074|H|showering.||
0427|075|H|   It is important to use this medication regularly at evenly||
0427|076|H|spaced intervals to get the most benefit from it. Use the exact||
0427|077|H|dose prescribed by your doctor. Do not use it more often or for||
0427|078|H|longer than prescribed. Do not use this medication for more than||
0427|079|H|3 months at a time unless directed by your doctor. Discuss the||
0427|080|H|risks and benefits with your doctor or pharmacist.||
0427|081|H|   For certain conditions (such as arthritis), it may take up to||
0427|082|H|2 weeks of using this drug regularly until you get the full||
0427|083|H|benefit.||
0427|084|H|   If you are using this drug "as needed" (not on a regular||
0427|085|H|schedule), remember that pain medications work best if they are||
0427|086|H|used as the first signs of pain occur. If you wait until the pain||
0427|087|H|has worsened, the medication may not work as well.||
0427|088|H|   Tell your doctor if your condition gets worse.||
0427|089|B|||
0427|090|S|SIDE EFFECTS:  See also Warning section.||
0427|091|S|   Skin irritation (such as dryness, redness, stinging),||
0427|092|S|drowsiness, or dizziness may occur. If any of these effects last||
0427|093|S|or get worse, tell your doctor or pharmacist right away.||
0427|094|S|   Remember that this medication has been prescribed because your||
0427|095|S|doctor has judged that the benefit to you is greater than the||
0427|096|S|risk of side effects. Many people using this medication do not||
0427|097|S|have serious side effects.||
0427|098|S|   This medication may raise your blood pressure. Check your||
0427|099|S|blood pressure regularly and tell your doctor if the results are||
0427|100|S|high.||
0427|101|S|   Tell your doctor right away if you have any serious side||
0427|102|S|effects, including: signs of kidney problems (such as change in||
0427|103|S|the amount of urine), symptoms of heart failure (such as swelling||
0427|104|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
0427|105|S|   This drug may rarely cause serious (possibly fatal) liver||
0427|106|S|disease. Get medical help right away if you have any symptoms of||
0427|107|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0427|108|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0427|109|S|urine.||
0427|110|S|   A very serious allergic reaction to this drug is rare.||
0427|111|S|However, get medical help right away if you notice any symptoms||
0427|112|S|of a serious allergic reaction, including: fever, swollen lymph||
0427|113|S|nodes, rash, itching/swelling (especially of the||
0427|114|S|face/tongue/throat), severe dizziness, trouble breathing.||
0427|115|S|   This is not a complete list of possible side effects. If you||
0427|116|S|notice other effects not listed above, contact your doctor or||
0427|117|S|pharmacist.||
0427|118|S|   In the US -||
0427|119|S|   Call your doctor for medical advice about side effects. You||
0427|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0427|121|S|www.fda.gov/medwatch.||
0427|122|S|   In Canada - Call your doctor for medical advice about side||
0427|123|S|effects. You may report side effects to Health Canada at||
0427|124|S|1-866-234-2345.||
0427|125|B|||
0427|126|P|PRECAUTIONS:  See also Warning section.||
0427|127|P|   Before using this medication, tell your doctor or pharmacist||
0427|128|P|if you are allergic to it; or to aspirin or other NSAIDs (such as||
0427|129|P|ibuprofen, naproxen, celecoxib); or if you have any other||
0427|130|P|allergies. This product may contain other inactive ingredients||
0427|131|P|(such as dimethyl sulfoxide, propylene glycol), which can cause||
0427|132|P|allergic reactions or other problems. Talk to your pharmacist for||
0427|133|P|more details.||
0427|134|P|   Before using this medication, tell your doctor or pharmacist||
0427|135|P|your medical history, especially of: asthma (including a history||
0427|136|P|of worsening breathing after taking aspirin or other NSAIDs),||
0427|137|P|liver disease, stomach/intestine problems (such as bleeding,||
0427|138|P|ulcers, Crohn's disease), heart disease (such as previous heart||
0427|139|P|attack), high blood pressure, stroke, swelling (edema, fluid||
0427|140|P|retention), blood disorders (such as anemia), bleeding/clotting||
0427|141|P|problems, growths in the nose (nasal polyps).||
0427|142|P|   Kidney problems can sometimes occur with the use of NSAID||
0427|143|P|medications, including diclofenac. Problems are more likely to||
0427|144|P|occur if you are dehydrated, have heart failure or kidney||
0427|145|P|disease, are an older adult, or if you take certain medications||
0427|146|P|(see also Drug Interactions section). Drink plenty of fluids as||
0427|147|P|directed by your doctor to prevent dehydration and tell your||
0427|148|P|doctor right away if you have a change in the amount of urine.||
0427|149|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0427|150|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0427|151|P|machinery, or do anything that needs alertness until you can do||
0427|152|P|it safely. Talk to your doctor if you are using marijuana||
0427|153|P|(cannabis).||
0427|154|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0427|155|P|and tobacco while using this medicine may increase your risk for||
0427|156|P|stomach bleeding. Limit alcohol and stop smoking. Ask your doctor||
0427|157|P|or pharmacist about how much alcohol you may safely drink.||
0427|158|P|   This medication may make the treated area more sensitive to||
0427|159|P|the sun. Limit your time in the sun. Avoid tanning booths and||
0427|160|P|sunlamps. Wear protective clothing when outdoors. Ask your doctor||
0427|161|P|whether you should use sunscreen along with this medication. Tell||
0427|162|P|your doctor right away if you get sunburned or have skin||
0427|163|P|blisters/redness.||
0427|164|P|   Before having surgery, tell your doctor or dentist about all||
0427|165|P|the products you use (including prescription drugs,||
0427|166|P|nonprescription drugs, and herbal products).||
0427|167|P|   Older adults may be at greater risk for stomach/intestinal||
0427|168|P|bleeding, kidney problems, heart attack, and stroke while using||
0427|169|P|this drug.||
0427|170|P|   Before using this medication, women of childbearing age should||
0427|171|P|talk with their doctor(s) about the benefits and risks. Tell your||
0427|172|P|doctor if you are pregnant or if you plan to become pregnant.||
0427|173|P|This medication may harm an unborn baby and cause problems with||
0427|174|P|normal labor/delivery. It is not recommended for use in pregnancy||
0427|175|P|from 20 weeks until delivery. If your doctor decides that you||
0427|176|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0427|177|P|you should use the lowest effective dose for the shortest||
0427|178|P|possible time. You should not use this medication after 30 weeks||
0427|179|P|of pregnancy.||
0427|180|P|   It is unknown if this form of diclofenac passes into breast||
0427|181|P|milk. Consult your doctor before breastfeeding.||
0427|182|B|||
0427|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0427|184|I|medications work or increase your risk for serious side effects.||
0427|185|I|This document does not contain all possible drug interactions.||
0427|186|I|Keep a list of all the products you use (including||
0427|187|I|prescription/nonprescription drugs and herbal products) and share||
0427|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
0427|189|I|the dosage of any medicines without your doctor's approval.||
0427|190|I|   Some products that may interact with this drug include:||
0427|191|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
0427|192|I|angiotensin II receptor blockers (such as losartan, valsartan),||
0427|193|I|cidofovir, corticosteroids (such as dexamethasone, prednisone),||
0427|194|I|lithium, methotrexate, "water pills" (diuretics such as||
0427|195|I|furosemide).||
0427|196|I|   This medication may increase the risk of bleeding when used||
0427|197|I|with other drugs that also may cause bleeding. Examples include||
0427|198|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0427|199|I|dabigatran/enoxaparin/warfarin, among others.||
0427|200|I|   Check all prescription and nonprescription medicine labels||
0427|201|I|carefully since many medications contain pain relievers/fever||
0427|202|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac, or||
0427|203|I|naproxen). These drugs are similar to diclofenac and may increase||
0427|204|I|your risk of side effects if taken together. However, if your||
0427|205|I|doctor has told you to take low-dose aspirin to prevent heart||
0427|206|I|attack or stroke (usually 81-162 milligrams a day), you should||
0427|207|I|keep taking the aspirin unless your doctor tells you not to. Ask||
0427|208|I|your doctor or pharmacist for more details.||
0427|209|B|||
0427|210|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0427|211|O|has overdosed and has serious symptoms such as passing out or||
0427|212|O|trouble breathing, call 911. Otherwise, call a poison control||
0427|213|O|center right away. US residents can call 1-800-222-1222. Canada||
0427|214|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0427|215|O|include: severe stomach pain, change in the amount of urine,||
0427|216|O|slow/shallow breathing.||
0427|217|B|||
0427|218|N|NOTES:  Do not share this medication with others.||
0427|219|N|   Lab and/or medical tests (such as blood pressure, complete||
0427|220|N|blood count, liver/kidney function) should be done while you are||
0427|221|N|using this medication. Keep all medical and lab appointments.||
0427|222|N|Consult your doctor for more details.||
0427|223|N|   Lifestyle changes (such as weight loss if needed,||
0427|224|N|strengthening/conditioning exercises) may help improve your||
0427|225|N|flexibility and joint function. Consult your doctor for specific||
0427|226|N|instructions.||
0427|227|B|||
0427|228|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0427|229|D|If it is near the time of the next dose, skip the missed dose.||
0427|230|D|Use your next dose at the regular time. Do not double the dose to||
0427|231|D|catch up.||
0427|232|B|||
0427|233|R|STORAGE:  Store at room temperature. Keep all medications away||
0427|234|R|from children and pets.||
0427|235|R|   Do not flush medications down the toilet or pour them into a||
0427|236|R|drain unless instructed to do so. Properly discard this product||
0427|237|R|when it is expired or no longer needed. Consult your pharmacist||
0427|238|R|or local waste disposal company.||
0427|239|B|||
0427|240|A|Information last revised November 2025.||
0427|241|A|Copyright(c) 2025 First Databank, Inc.||
0427|242|B|||
0428|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0428|002|Z|does NOT have all possible information about this product. This||
0428|003|Z|information does not assure that this product is safe, effective,||
0428|004|Z|or appropriate for you. This information is not individual||
0428|005|Z|medical advice and does not substitute for the advice of your||
0428|006|Z|health care professional. Always ask your health care||
0428|007|Z|professional for complete information about this product and your||
0428|008|Z|specific health needs.||
0428|009|B|||
0428|010|T|ETODOLAC - ORAL||
0428|011|F|(EE-to-DOE-lak)||
0428|012|B|||
0428|013|C|COMMON BRAND NAME(S): Lodine||
0428|014|B|||
0428|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0428|016|W|etodolac) may rarely increase the risk of a heart attack or||
0428|017|W|stroke. This effect can happen at any time while taking this drug||
0428|018|W|but is more likely if you take it for a long time. The risk may||
0428|019|W|be greater in older adults or if you have heart disease or||
0428|020|W|increased risk for heart disease (for example, due to smoking,||
0428|021|W|family history of heart disease, or conditions such as high blood||
0428|022|W|pressure or diabetes). Do not take this drug right before or||
0428|023|W|after heart bypass surgery (CABG).||
0428|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0428|025|W|bleeding from the stomach or intestines. This effect can occur||
0428|026|W|without warning symptoms at any time while taking this drug.||
0428|027|W|Older adults may be at higher risk for this effect.||
0428|028|W|   Stop taking etodolac and get medical help right away if you||
0428|029|W|notice any of these rare but serious side effects:||
0428|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0428|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0428|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0428|033|W|side of the body, trouble speaking, sudden vision changes.||
0428|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0428|035|W|of taking this drug.||
0428|036|B|||
0428|037|U|USES:  See also Warning section.||
0428|038|U|   Etodolac is used to relieve pain from various conditions. It||
0428|039|U|also reduces pain, swelling, and joint stiffness from arthritis.||
0428|040|U|This medication is known as a nonsteroidal anti-inflammatory drug||
0428|041|U|(NSAID). It works by blocking your body's production of certain||
0428|042|U|natural substances that cause inflammation.||
0428|043|U|   If you are treating a chronic condition such as arthritis, ask||
0428|044|U|your doctor about non-drug treatments and/or using other||
0428|045|U|medications to treat your pain.||
0428|046|B|||
0428|047|V|OTHER USES:  This section contains uses of this drug that are not||
0428|048|V|listed in the approved professional labeling for the drug but||
0428|049|V|that may be prescribed by your health care professional. Use this||
0428|050|V|drug for a condition that is listed in this section only if it||
0428|051|V|has been so prescribed by your health care professional.||
0428|052|V|   This medication may also be used for gout attacks.||
0428|053|B|||
0428|054|H|HOW TO USE:  Read the Medication Guide provided by your||
0428|055|H|pharmacist before you start taking etodolac and each time you get||
0428|056|H|a refill. If you have any questions, ask your doctor or||
0428|057|H|pharmacist.||
0428|058|H|   Take this medication by mouth as directed by your doctor,||
0428|059|H|usually 2 to 4 times a day. Take this medication with a full||
0428|060|H|glass of water (8 ounces/240 milliliters) unless your doctor||
0428|061|H|directs you otherwise. Do not lie down for at least 10 minutes||
0428|062|H|after taking this medication. If stomach upset occurs while||
0428|063|H|taking this medication, take it with food, milk, or an antacid.||
0428|064|H|   The dosage is based on your medical condition and response to||
0428|065|H|treatment. To reduce your risk of stomach bleeding and other side||
0428|066|H|effects, take this medication at the lowest effective dose for||
0428|067|H|the shortest possible time. Do not increase your dose or use this||
0428|068|H|drug more often or for longer than prescribed. Discuss the risks||
0428|069|H|and benefits with your doctor or pharmacist.||
0428|070|H|   For certain conditions (such as arthritis), it may take up to||
0428|071|H|2 weeks of taking this drug regularly until you get the full||
0428|072|H|benefit.||
0428|073|H|   If you are taking this drug "as needed" (not on a regular||
0428|074|H|schedule), remember that pain medications work best if they are||
0428|075|H|used as the first signs of pain occur. If you wait until the pain||
0428|076|H|has worsened, the medication may not work as well.||
0428|077|H|   Tell your doctor if your condition gets worse.||
0428|078|B|||
0428|079|S|SIDE EFFECTS:  See also Warning section.||
0428|080|S|   Upset stomach, nausea, diarrhea, gas, weakness, drowsiness,||
0428|081|S|dizziness, or blurred vision may occur. If any of these effects||
0428|082|S|last or get worse, tell your doctor or pharmacist promptly.||
0428|083|S|   Remember that this medication has been prescribed because your||
0428|084|S|doctor has judged that the benefit to you is greater than the||
0428|085|S|risk of side effects. Many people using this medication do not||
0428|086|S|have serious side effects.||
0428|087|S|   This medication may raise your blood pressure. Check your||
0428|088|S|blood pressure regularly and tell your doctor if the results are||
0428|089|S|high.||
0428|090|S|   Tell your doctor right away if you have any serious side||
0428|091|S|effects, including: hearing changes (such as ringing in the||
0428|092|S|ears), mental/mood changes, easy bleeding/bruising,||
0428|093|S|difficult/painful swallowing, signs of kidney problems (such as||
0428|094|S|change in the amount of urine, pink/bloody urine), symptoms of||
0428|095|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
0428|096|S|unusual/sudden weight gain).||
0428|097|S|   Etodolac may rarely cause serious (possibly fatal) liver||
0428|098|S|disease. Get medical help right away if you have any symptoms of||
0428|099|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0428|100|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0428|101|S|urine.||
0428|102|S|   A very serious allergic reaction to this drug is rare.||
0428|103|S|However, get medical help right away if you notice any symptoms||
0428|104|S|of a serious allergic reaction, including: fever, swollen lymph||
0428|105|S|nodes, rash, itching/swelling (especially of the||
0428|106|S|face/tongue/throat), severe dizziness, trouble breathing.||
0428|107|S|   This is not a complete list of possible side effects. If you||
0428|108|S|notice other effects not listed above, contact your doctor or||
0428|109|S|pharmacist.||
0428|110|S|   In the US -||
0428|111|S|   Call your doctor for medical advice about side effects. You||
0428|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0428|113|S|www.fda.gov/medwatch.||
0428|114|S|   In Canada - Call your doctor for medical advice about side||
0428|115|S|effects. You may report side effects to Health Canada at||
0428|116|S|1-866-234-2345.||
0428|117|B|||
0428|118|P|PRECAUTIONS:  See also Warning section.||
0428|119|P|   Before taking etodolac, tell your doctor or pharmacist if you||
0428|120|P|are allergic to it; or to aspirin or other NSAIDs (such as||
0428|121|P|ibuprofen, naproxen, celecoxib); or if you have any other||
0428|122|P|allergies. This product may contain inactive ingredients, which||
0428|123|P|can cause allergic reactions or other problems. Talk to your||
0428|124|P|pharmacist for more details.||
0428|125|P|   Before taking this medication, tell your doctor or pharmacist||
0428|126|P|your medical history, especially of: asthma (including a history||
0428|127|P|of worsening breathing after taking aspirin or other NSAIDs),||
0428|128|P|blood disorders (such as anemia, bleeding/clotting problems),||
0428|129|P|growths in the nose (nasal polyps), heart disease (such as||
0428|130|P|previous heart attack), high blood pressure, liver disease,||
0428|131|P|stroke, swelling (edema, fluid retention),||
0428|132|P|stomach/intestinal/esophagus problems (such as bleeding,||
0428|133|P|heartburn, ulcers).||
0428|134|P|   Kidney problems can sometimes occur with the use of NSAID||
0428|135|P|medications, including etodolac. Problems are more likely to||
0428|136|P|occur if you are dehydrated, have heart failure or kidney||
0428|137|P|disease, are an older adult, or if you take certain medications||
0428|138|P|(see also Drug Interactions section). Drink plenty of fluids as||
0428|139|P|directed by your doctor to prevent dehydration and tell your||
0428|140|P|doctor right away if you have pink/bloody urine or any unusual||
0428|141|P|change in the amount of urine.||
0428|142|P|   This drug may make you dizzy or drowsy or cause blurred||
0428|143|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
0428|144|P|Do not drive, use machinery, or do anything that needs alertness||
0428|145|P|or clear vision until you can do it safely. Limit alcoholic||
0428|146|P|beverages. Talk to your doctor if you are using marijuana||
0428|147|P|(cannabis).||
0428|148|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0428|149|P|and tobacco, especially when combined with this medicine, may||
0428|150|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0428|151|P|smoking.||
0428|152|P|   This medication may make you more sensitive to the sun. Limit||
0428|153|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0428|154|P|sunscreen and wear protective clothing when outdoors. Tell your||
0428|155|P|doctor right away if you get sunburned or have skin||
0428|156|P|blisters/redness.||
0428|157|P|   Before having surgery, tell your doctor or dentist about all||
0428|158|P|the products you use (including prescription drugs,||
0428|159|P|nonprescription drugs, and herbal products).||
0428|160|P|   Older adults may be at greater risk for stomach/intestinal||
0428|161|P|bleeding, kidney problems, heart attack, and stroke while using||
0428|162|P|this drug.||
0428|163|P|   Before using this medication, women of childbearing age should||
0428|164|P|talk with their doctor(s) about the benefits and risks. Tell your||
0428|165|P|doctor if you are pregnant or if you plan to become pregnant.||
0428|166|P|This medication may harm an unborn baby and cause problems with||
0428|167|P|normal labor/delivery. It is not recommended for use in pregnancy||
0428|168|P|from 20 weeks until delivery. If your doctor decides that you||
0428|169|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0428|170|P|you should use the lowest effective dose for the shortest||
0428|171|P|possible time. You should not use this medication after 30 weeks||
0428|172|P|of pregnancy.||
0428|173|P|   It is unknown if this medication passes into breast milk.||
0428|174|P|Consult your doctor before breastfeeding.||
0428|175|B|||
0428|176|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0428|177|I|medications work or increase your risk for serious side effects.||
0428|178|I|This document does not contain all possible drug interactions.||
0428|179|I|Keep a list of all the products you use (including||
0428|180|I|prescription/nonprescription drugs and herbal products) and share||
0428|181|I|it with your doctor and pharmacist. Do not start, stop, or change||
0428|182|I|the dosage of any medicines without your doctor's approval.||
0428|183|I|   Some products that may interact with this drug are: aliskiren,||
0428|184|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
0428|185|I|receptor blockers (such as losartan, valsartan), cidofovir,||
0428|186|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
0428|187|I|methotrexate, "water pills" (diuretics such as furosemide).||
0428|188|I|   This medication may increase the risk of bleeding when taken||
0428|189|I|with other drugs that also may cause bleeding. Examples include||
0428|190|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0428|191|I|dabigatran/enoxaparin/warfarin, among others.||
0428|192|I|   Check all prescription and nonprescription medicine labels||
0428|193|I|carefully since many medications contain pain relievers/fever||
0428|194|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
0428|195|I|naproxen). These drugs are similar to etodolac and may increase||
0428|196|I|your risk of side effects if taken together. However, if your||
0428|197|I|doctor has told you to take low-dose aspirin to prevent heart||
0428|198|I|attack or stroke (usually 81-162 milligrams a day), you should||
0428|199|I|keep taking the aspirin unless your doctor tells you not to. Ask||
0428|200|I|your doctor or pharmacist for more details.||
0428|201|I|   This medication may interfere with certain lab tests, possibly||
0428|202|I|causing false test results. Make sure lab personnel and all your||
0428|203|I|doctors know you use this drug.||
0428|204|B|||
0428|205|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0428|206|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0428|207|O|poison control center right away. US residents can call||
0428|208|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0428|209|O|Symptoms of overdose may include: severe stomach pain,||
0428|210|O|slow/shallow breathing, extreme drowsiness.||
0428|211|B|||
0428|212|N|NOTES:  Do not share this medication with others.||
0428|213|N|   Lab and/or medical tests (such as complete blood count,||
0428|214|N|liver/kidney function, blood pressure) may be done while you are||
0428|215|N|using this medication. Keep all medical and lab appointments.||
0428|216|N|Consult your doctor for more details.||
0428|217|N|   Lifestyle changes (such as weight loss if needed,||
0428|218|N|strengthening/conditioning exercises) may help improve your||
0428|219|N|flexibility and joint function. Consult your doctor for specific||
0428|220|N|instructions.||
0428|221|B|||
0428|222|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
0428|223|D|(not just "as needed") and you miss a dose, take it as soon as||
0428|224|D|you remember. If it is near the time of the next dose, skip the||
0428|225|D|missed dose. Take your next dose at the regular time. Do not||
0428|226|D|double the dose to catch up.||
0428|227|B|||
0428|228|R|STORAGE:  Store at room temperature away from light and moisture.||
0428|229|R|Do not store in the bathroom. Keep all medications away from||
0428|230|R|children and pets.||
0428|231|R|   Do not flush medications down the toilet or pour them into a||
0428|232|R|drain unless instructed to do so. Properly discard this product||
0428|233|R|when it is expired or no longer needed. Consult your pharmacist||
0428|234|R|or local waste disposal company.||
0428|235|B|||
0428|236|A|Information last revised May 2024.||
0428|237|A|Copyright(c) 2025 First Databank, Inc.||
0428|238|B|||
0429|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0429|002|Z|does NOT have all possible information about this product. This||
0429|003|Z|information does not assure that this product is safe, effective,||
0429|004|Z|or appropriate for you. This information is not individual||
0429|005|Z|medical advice and does not substitute for the advice of your||
0429|006|Z|health care professional. Always ask your health care||
0429|007|Z|professional for complete information about this product and your||
0429|008|Z|specific health needs.||
0429|009|B|||
0429|010|T|METHADONE - INJECTION||
0429|011|F|(METH-a-done)||
0429|012|B|||
0429|013|C|COMMON BRAND NAME(S): Dolophine||
0429|014|B|||
0429|015|W|WARNING:  Methadone has a risk for abuse and addiction, which can||
0429|016|W|lead to overdose and death. Methadone may also cause severe,||
0429|017|W|possibly fatal, breathing problems and heartbeat problems. To||
0429|018|W|lower your risk, your doctor should have you use the smallest||
0429|019|W|dose of methadone that works, and use it for the shortest||
0429|020|W|possible time. Do not increase your dose or use this medication||
0429|021|W|more often than directed. See also How to Use section for more||
0429|022|W|information about addiction.||
0429|023|W|   Ask your doctor or pharmacist if you should have medication||
0429|024|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0429|025|W|Teach your family or household members about the signs of an||
0429|026|W|opioid overdose and how to treat it.||
0429|027|W|   The risk for severe breathing problems or heartbeat problems||
0429|028|W|is higher when you start this medication, when you are switching||
0429|029|W|from another opioid to methadone, after a dose increase, or if||
0429|030|W|you use the wrong dose/strength. Breathing problems from||
0429|031|W|methadone may not happen right away after using a dose. Most||
0429|032|W|heartbeat problems have happened in people using large doses of||
0429|033|W|methadone for pain relief, but this problem can also occur in||
0429|034|W|people getting smaller doses to treat opioid addiction. Using||
0429|035|W|this medication with alcohol or other drugs that can cause||
0429|036|W|drowsiness or breathing problems may cause very serious side||
0429|037|W|effects, including death. Also, other medications can affect the||
0429|038|W|removal of methadone from your body, which may affect how||
0429|039|W|methadone works. Be sure you know how to use methadone and what||
0429|040|W|other drugs you should avoid taking with it. See also Drug||
0429|041|W|Interactions section. Get medical help right away if any of these||
0429|042|W|very serious side effects occur: slow/shallow breathing, unusual||
0429|043|W|lightheadedness, severe drowsiness/dizziness, difficulty waking||
0429|044|W|up, fast/irregular heartbeat, fainting.||
0429|045|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0429|046|W|or abuse. If someone accidentally uses or swallows this drug, get||
0429|047|W|medical help right away.||
0429|048|W|   Before using this medication, women of childbearing age should||
0429|049|W|talk with their doctor(s) about the risks and benefits. Pregnancy||
0429|050|W|may affect the amount of this drug in your body, so tell your||
0429|051|W|doctor if you are pregnant or if you plan to become pregnant.||
0429|052|W|During pregnancy, this medication should be used only when||
0429|053|W|clearly needed. It may slightly increase the risk of birth||
0429|054|W|defects if used during the first two months of pregnancy. Also,||
0429|055|W|using it for a long time or in high doses near the expected||
0429|056|W|delivery date may harm the unborn baby. To lessen the risk, use||
0429|057|W|the smallest effective dose for the shortest possible time.||
0429|058|W|Babies born to mothers who use this drug for a long time may||
0429|059|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0429|060|W|doctor right away if you notice any symptoms in your newborn baby||
0429|061|W|such as crying that doesn't stop, slow/shallow breathing,||
0429|062|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0429|063|W|difficulty gaining weight.||
0429|064|B|||
0429|065|U|USES:  This medication is used to treat moderate to severe pain.||
0429|066|U|Methadone is an opioid medication. It acts on certain centers in||
0429|067|U|the brain to relieve pain.||
0429|068|U|   This medication is also used to treat opioid use disorder as||
0429|069|U|part of an approved treatment program. It helps prevent||
0429|070|U|withdrawal symptoms caused by stopping other opioids.||
0429|071|B|||
0429|072|H|HOW TO USE:  See also Warning section.||
0429|073|H|   Read the Patient Information Leaflet if available from your||
0429|074|H|pharmacist before you start using methadone and each time you get||
0429|075|H|a refill. If you have any questions, ask your doctor or||
0429|076|H|pharmacist.||
0429|077|H|   Depending on your product, this medication is given by||
0429|078|H|injection into a vein, into a muscle, or under the skin. Use it||
0429|079|H|exactly as directed by your doctor. The dosage is based on your||
0429|080|H|medical condition and response to treatment. If you have nausea||
0429|081|H|after using this medication, ask your doctor or pharmacist about||
0429|082|H|ways to decrease it (such as lying down for 1 to 2 hours with as||
0429|083|H|little head movement as possible).||
0429|084|H|   If you are using this medication at home, learn all||
0429|085|H|preparation and usage instructions from your health care||
0429|086|H|professional. Before using, check this product for particles or||
0429|087|H|discoloration. If either is present, do not use the liquid.||
0429|088|H|Before injecting each dose, clean the injection site with rubbing||
0429|089|H|alcohol. If this medication is given into a muscle or under the||
0429|090|H|skin, change the injection site each time to lessen injury under||
0429|091|H|the skin. Learn how to store and discard medical supplies safely.||
0429|092|H|   If you are using this medication for pain, remember that pain||
0429|093|H|medications work best if they are used as the first signs of pain||
0429|094|H|occur. If you wait until the pain has worsened, the medication||
0429|095|H|may not work as well.||
0429|096|H|   Suddenly stopping this medication may cause withdrawal,||
0429|097|H|especially if you have used it for a long time or in high doses.||
0429|098|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0429|099|H|Tell your doctor or pharmacist right away if you have any||
0429|100|H|withdrawal symptoms such as restlessness, mental/mood changes||
0429|101|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0429|102|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0429|103|H|aches, or sudden changes in behavior.||
0429|104|H|   When this medication is used for a long time, it may not work||
0429|105|H|as well. Your doctor may need to increase your dose or change||
0429|106|H|your medication. Talk with your doctor if this medication stops||
0429|107|H|working well.||
0429|108|H|   Though it helps many people, this medication may sometimes||
0429|109|H|cause addiction. This risk may be higher if you have a||
0429|110|H|mental/mood disorder or a substance use disorder (such as overuse||
0429|111|H|of or addiction to drugs/alcohol). Use this medication exactly as||
0429|112|H|prescribed to lower the risk of addiction. Ask your doctor or||
0429|113|H|pharmacist for more details.||
0429|114|H|   Tell your doctor if your condition does not get better or if||
0429|115|H|it gets worse, or if you have any new pain.||
0429|116|B|||
0429|117|S|SIDE EFFECTS:  See also Warning section.||
0429|118|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0429|119|S|dry mouth, drowsiness, and increased sweating may occur. Pain,||
0429|120|S|redness, or swelling at the injection site may occur if this||
0429|121|S|medication is given into a muscle or under the skin. If any of||
0429|122|S|these effects last or get worse, tell your doctor or pharmacist||
0429|123|S|promptly.||
0429|124|S|   To prevent constipation, eat dietary fiber, drink enough||
0429|125|S|water, and exercise. You may also need to take a laxative. Ask||
0429|126|S|your pharmacist which type of laxative is right for you.||
0429|127|S|   To reduce the risk of dizziness and lightheadedness, get up||
0429|128|S|slowly when rising from a sitting or lying position.||
0429|129|S|   Remember that this medication has been prescribed because your||
0429|130|S|doctor has judged that the benefit to you is greater than the||
0429|131|S|risk of side effects. Many people using this medication do not||
0429|132|S|have serious side effects.||
0429|133|S|   Tell your doctor right away if you have any serious side||
0429|134|S|effects, including: interrupted breathing during sleep (sleep||
0429|135|S|apnea), mental/mood changes (such as agitation, confusion,||
0429|136|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
0429|137|S|signs of your adrenal glands not working well (such as loss of||
0429|138|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
0429|139|S|   Get medical help right away if you have any very serious side||
0429|140|S|effects, including: seizure, severe drowsiness/difficulty waking||
0429|141|S|up.||
0429|142|S|   A very serious allergic reaction to this drug is rare.||
0429|143|S|However, get medical help right away if you notice any symptoms||
0429|144|S|of a serious allergic reaction, including: rash, itching/swelling||
0429|145|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0429|146|S|breathing.||
0429|147|S|   This is not a complete list of possible side effects. If you||
0429|148|S|notice other effects not listed above, contact your doctor or||
0429|149|S|pharmacist.||
0429|150|S|   In the US -||
0429|151|S|   Call your doctor for medical advice about side effects. You||
0429|152|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0429|153|S|www.fda.gov/medwatch.||
0429|154|S|   In Canada - Call your doctor for medical advice about side||
0429|155|S|effects. You may report side effects to Health Canada at||
0429|156|S|1-866-234-2345.||
0429|157|B|||
0429|158|P|PRECAUTIONS:  Before using methadone, tell your doctor or||
0429|159|P|pharmacist if you are allergic to it; or if you have any other||
0429|160|P|allergies. This product may contain inactive ingredients, which||
0429|161|P|can cause allergic reactions or other problems. Talk to your||
0429|162|P|pharmacist for more details.||
0429|163|P|   Before using this medication, tell your doctor or pharmacist||
0429|164|P|your medical history, especially of: brain disorders (such as||
0429|165|P|head injury, tumor, seizures), breathing problems (such as||
0429|166|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0429|167|P|kidney disease, liver disease, mental/mood disorders (such as||
0429|168|P|confusion, depression, thoughts of suicide), personal or family||
0429|169|P|history of a substance use disorder (such as overuse of or||
0429|170|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
0429|171|P|blockage, constipation, diarrhea due to infection, paralytic||
0429|172|P|ileus), difficulty urinating (such as due to enlarged prostate),||
0429|173|P|disease of the pancreas (pancreatitis), gallbladder disease.||
0429|174|P|   Methadone may cause a condition that affects the heart rhythm||
0429|175|P|(QT prolongation). QT prolongation can rarely cause serious||
0429|176|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0429|177|P|as severe dizziness, fainting) that need medical attention right||
0429|178|P|away.||
0429|179|P|   The risk of QT prolongation may be increased if you have||
0429|180|P|certain medical conditions or are taking other drugs that may||
0429|181|P|cause QT prolongation. Before using methadone, tell your doctor||
0429|182|P|or pharmacist of all the drugs you take and if you have any of||
0429|183|P|the following conditions: certain heart problems (heart failure,||
0429|184|P|slow heartbeat, QT prolongation in the EKG), family history of||
0429|185|P|certain heart problems (QT prolongation in the EKG, sudden||
0429|186|P|cardiac death).||
0429|187|P|   Low levels of potassium or magnesium in the blood may also||
0429|188|P|increase your risk of QT prolongation. This risk may increase if||
0429|189|P|you use certain drugs (such as diuretics/"water pills") or if you||
0429|190|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0429|191|P|Talk to your doctor about using methadone safely.||
0429|192|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0429|193|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0429|194|P|machinery, or do anything that needs alertness until you can do||
0429|195|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0429|196|P|are using marijuana (cannabis).||
0429|197|P|   Before having surgery, tell your doctor or dentist about all||
0429|198|P|the products you use (including prescription drugs,||
0429|199|P|nonprescription drugs, and herbal products).||
0429|200|P|   Older adults may be more sensitive to the side effects of this||
0429|201|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
0429|202|P|breathing, and QT prolongation (see above).||
0429|203|P|   During pregnancy, this medication should be used only when||
0429|204|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0429|205|P|benefits with your doctor. (See also Warning section.)||
0429|206|P|   This drug passes into breast milk and may have undesirable||
0429|207|P|effects on a nursing infant. Tell the doctor right away if your||
0429|208|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0429|209|P|breathing. Consult your doctor before breastfeeding or if you||
0429|210|P|plan to stop breastfeeding.||
0429|211|B|||
0429|212|I|DRUG INTERACTIONS:  See also Warning section.||
0429|213|I|   Drug interactions may change how your medications work or||
0429|214|I|increase your risk for serious side effects. This document does||
0429|215|I|not contain all possible drug interactions. Keep a list of all||
0429|216|I|the products you use (including prescription/nonprescription||
0429|217|I|drugs and herbal products) and share it with your doctor and||
0429|218|I|pharmacist. Do not start, stop, or change the dosage of any||
0429|219|I|medicines without your doctor's approval.||
0429|220|I|   Some products that may interact with this drug include:||
0429|221|I|certain pain medications (mixed opioid agonist-antagonists such||
0429|222|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0429|223|I|samidorphan.||
0429|224|I|   Taking MAO inhibitors with this medication may cause a serious||
0429|225|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
0429|226|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0429|227|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0429|228|I|selegiline, tranylcypromine) during treatment with this||
0429|229|I|medication. Most MAO inhibitors should also not be taken for two||
0429|230|I|weeks before and after treatment with this medication. Ask your||
0429|231|I|doctor when to start or stop taking this medication.||
0429|232|I|   Other medications can affect the removal of methadone from||
0429|233|I|your body, which may affect how methadone works. Examples include||
0429|234|I|St. John's wort, azole antifungals (such as itraconazole),||
0429|235|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
0429|236|I|rifampin), drugs used to treat seizures (such as carbamazepine),||
0429|237|I|among others.||
0429|238|I|   The risk of serious side effects (such as slow/shallow||
0429|239|I|breathing, severe drowsiness/dizziness) may be increased if this||
0429|240|I|medication is used with other products that may also cause||
0429|241|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0429|242|I|if you are using other products such as other opioid pain or||
0429|243|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0429|244|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0429|245|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0429|246|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0429|247|I|cetirizine, diphenhydramine).||
0429|248|I|   Check the labels on all your medicines (such as allergy or||
0429|249|I|cough-and-cold products) because they may contain ingredients||
0429|250|I|that cause drowsiness. Ask your pharmacist about using those||
0429|251|I|products safely.||
0429|252|I|   This medication may interfere with certain lab tests (such as||
0429|253|I|amylase and lipase levels), possibly causing false test results.||
0429|254|I|Make sure lab personnel and all your doctors know you use this||
0429|255|I|drug.||
0429|256|B|||
0429|257|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0429|258|O|as passing out or trouble breathing, give them naloxone or||
0429|259|O|nalmefene if available, then call 911. If the person is awake and||
0429|260|O|has no symptoms, call a poison control center right away. US||
0429|261|O|residents can call 1-800-222-1222. Canada residents can call||
0429|262|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0429|263|O|breathing, extreme drowsiness, slow heartbeat, severe dizziness,||
0429|264|O|pinpoint pupils, coma.||
0429|265|B|||
0429|266|N|NOTES:  Do not share this medication with others. Sharing it is||
0429|267|N|against the law.||
0429|268|N|   This medication has been prescribed for your current condition||
0429|269|N|only. Do not use it later for another condition unless told to do||
0429|270|N|so by your doctor. A different medication may be necessary in||
0429|271|N|those cases.||
0429|272|B|||
0429|273|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0429|274|D|If it is near the time of the next dose, skip the missed dose.||
0429|275|D|Use your next dose at the regular time. Do not double the dose to||
0429|276|D|catch up.||
0429|277|B|||
0429|278|R|STORAGE:  Store at room temperature away from light. Keep all||
0429|279|R|medications away from children and pets.||
0429|280|R|   Do not flush medications down the toilet or pour them into a||
0429|281|R|drain unless instructed to do so. Properly discard this product||
0429|282|R|when it is expired or no longer needed. Consult your pharmacist||
0429|283|R|or local waste disposal company.||
0429|284|B|||
0429|285|A|Information last revised August 2025.||
0429|286|A|Copyright(c) 2025 First Databank, Inc.||
0429|287|B|||
0432|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0432|002|Z|does NOT have all possible information about this product. This||
0432|003|Z|information does not assure that this product is safe, effective,||
0432|004|Z|or appropriate for you. This information is not individual||
0432|005|Z|medical advice and does not substitute for the advice of your||
0432|006|Z|health care professional. Always ask your health care||
0432|007|Z|professional for complete information about this product and your||
0432|008|Z|specific health needs.||
0432|009|B|||
0432|010|T|ACYCLOVIR CREAM - TOPICAL||
0432|011|F|(ay-SYE-kloe-vir)||
0432|012|B|||
0432|013|C|COMMON BRAND NAME(S): Zovirax||
0432|014|B|||
0432|015|U|USES:  This medication is used to treat "cold sores/fever||
0432|016|U|blisters" (herpes labialis). It can speed up healing of the sores||
0432|017|U|and decrease symptoms (such as tingling, pain, burning, itching).||
0432|018|U|Acyclovir belongs to a class of medications known as antivirals.||
0432|019|U|It works by stopping the growth of the virus. This medication||
0432|020|U|does not cure herpes, and it does not prevent passing the||
0432|021|U|infection to someone else. It does not prevent a future||
0432|022|U|occurrence.||
0432|023|B|||
0432|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0432|025|H|from your pharmacist before you start using acyclovir and each||
0432|026|H|time you get a refill. If you have any questions, ask your doctor||
0432|027|H|or pharmacist.||
0432|028|H|   Use this medication at the first sign of infection (such as||
0432|029|H|tingling, burning, redness). Wash your hands with soap and water||
0432|030|H|before and after applying this medication. Clean and dry the||
0432|031|H|affected areas before applying the medication. Apply to the||
0432|032|H|affected area and rub in gently as directed by your doctor,||
0432|033|H|usually 5 times a day (every 3 to 4 hours) for 4 days for cold||
0432|034|H|sores. Apply enough cream to cover all affected areas||
0432|035|H|(red/tingling/burning areas, sores).||
0432|036|H|   Apply to skin only. Do not apply this medication in the eyes||
0432|037|H|or nose, inside the mouth, or inside the vagina. If you do get||
0432|038|H|medication in those areas, flush with plenty of water.||
0432|039|H|   The dosage is based on your medical condition, type of||
0432|040|H|infection, and response to treatment. Do not use this drug more||
0432|041|H|often or for longer than prescribed.||
0432|042|H|   Use this medication regularly to get the most benefit from it.||
0432|043|H|This medication works best when the amount of drug absorbed by||
0432|044|H|the skin stays at a constant level. Use this drug at evenly||
0432|045|H|spaced intervals. To help you remember, use it at the same times||
0432|046|H|each day.||
0432|047|H|   To prevent washing off the medication, do not bathe, shower,||
0432|048|H|or swim right after applying it.||
0432|049|H|   Do not apply other skin products (such as drugs, cosmetics,||
0432|050|H|sun screens, or lip balms) unless told to do so by your doctor.||
0432|051|H|Do not cover the area with plastic or waterproof bandages unless||
0432|052|H|told to do so by your doctor.||
0432|053|H|   Cold sores (herpes) can spread easily. Acyclovir cream does||
0432|054|H|not prevent the spread of herpes. Avoid close physical contact||
0432|055|H|with others (such as kissing) during an outbreak until the cold||
0432|056|H|sores have completely healed. Also, try not to touch the cold||
0432|057|H|sore, and wash your hands if you do touch the cold sore.||
0432|058|H|   Tell your doctor if your condition lasts or gets worse after||
0432|059|H|treatment is finished.||
0432|060|B|||
0432|061|S|SIDE EFFECTS:  Dry/cracked lips, burning, stinging, or flaky skin||
0432|062|S|may occur. If any of these effects last or get worse, tell your||
0432|063|S|doctor or pharmacist promptly.||
0432|064|S|   Remember that this medication has been prescribed because your||
0432|065|S|doctor has judged that the benefit to you is greater than the||
0432|066|S|risk of side effects. Many people using this medication do not||
0432|067|S|have serious side effects.||
0432|068|S|   A very serious allergic reaction to this drug is rare.||
0432|069|S|However, get medical help right away if you notice any symptoms||
0432|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0432|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0432|072|S|breathing.||
0432|073|S|   This is not a complete list of possible side effects. If you||
0432|074|S|notice other effects not listed above, contact your doctor or||
0432|075|S|pharmacist.||
0432|076|S|   In the US -||
0432|077|S|   Call your doctor for medical advice about side effects. You||
0432|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0432|079|S|www.fda.gov/medwatch.||
0432|080|S|   In Canada - Call your doctor for medical advice about side||
0432|081|S|effects. You may report side effects to Health Canada at||
0432|082|S|1-866-234-2345.||
0432|083|B|||
0432|084|P|PRECAUTIONS:  Before using acyclovir, tell your doctor or||
0432|085|P|pharmacist if you are allergic to it; or to valacyclovir; or if||
0432|086|P|you have any other allergies. This product may contain inactive||
0432|087|P|ingredients, which can cause allergic reactions or other||
0432|088|P|problems. Talk to your pharmacist for more details.||
0432|089|P|   Before using this medication, tell your doctor or pharmacist||
0432|090|P|your medical history.||
0432|091|P|   Before having surgery, tell your doctor or dentist about all||
0432|092|P|the products you use (including prescription drugs,||
0432|093|P|nonprescription drugs, and herbal products).||
0432|094|P|   Tell your doctor if you are pregnant before using this||
0432|095|P|medication. Discuss the risks and benefits with your doctor.||
0432|096|P|   Acyclovir may pass into breast milk in small amounts. However,||
0432|097|P|the drug is unlikely to harm a nursing infant. Consult your||
0432|098|P|doctor before breastfeeding. Avoid breastfeeding if you have||
0432|099|P|herpes sores on or near your breast.||
0432|100|B|||
0432|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0432|102|I|medications work or increase your risk for serious side effects.||
0432|103|I|This document does not contain all possible drug interactions.||
0432|104|I|Keep a list of all the products you use (including||
0432|105|I|prescription/nonprescription drugs and herbal products) and share||
0432|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
0432|107|I|the dosage of any medicines without your doctor's approval.||
0432|108|B|||
0432|109|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0432|110|O|has overdosed and has serious symptoms such as passing out or||
0432|111|O|trouble breathing, call 911. Otherwise, call a poison control||
0432|112|O|center right away. US residents can call 1-800-222-1222. Canada||
0432|113|O|residents can call 1-844-764-7669.||
0432|114|B|||
0432|115|N|NOTES:  Do not share this medication with others. Doing so may||
0432|116|N|spread the infection.||
0432|117|N|   Cold sore outbreaks can be caused by many factors such as||
0432|118|N|stress, hormonal changes (such as pregnancy, menstrual period),||
0432|119|N|injury/surgery on the mouth (such as dental work), tiredness,||
0432|120|N|sunlight, cold weather, or fever/cold/flu.||
0432|121|B|||
0432|122|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0432|123|D|If it is near the time of the next dose, skip the missed dose.||
0432|124|D|Use your next dose at the regular time. Do not double the dose to||
0432|125|D|catch up.||
0432|126|B|||
0432|127|R|STORAGE:  Store at room temperature. Keep all medications away||
0432|128|R|from children and pets.||
0432|129|R|   Do not flush medications down the toilet or pour them into a||
0432|130|R|drain unless instructed to do so. Properly discard this product||
0432|131|R|when it is expired or no longer needed. Consult your pharmacist||
0432|132|R|or local waste disposal company.||
0432|133|B|||
0432|134|A|Information last revised May 2024.||
0432|135|A|Copyright(c) 2025 First Databank, Inc.||
0432|136|B|||
0433|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0433|002|Z|does NOT have all possible information about this product. This||
0433|003|Z|information does not assure that this product is safe, effective,||
0433|004|Z|or appropriate for you. This information is not individual||
0433|005|Z|medical advice and does not substitute for the advice of your||
0433|006|Z|health care professional. Always ask your health care||
0433|007|Z|professional for complete information about this product and your||
0433|008|Z|specific health needs.||
0433|009|B|||
0433|010|T|CICLOPIROX - TOPICAL||
0433|011|F|(SYE-kloe-PIR-ox)||
0433|012|B|||
0433|013|C|COMMON BRAND NAME(S): Loprox||
0433|014|B|||
0433|015|U|USES:  This medication is used to treat fungal skin infections||
0433|016|U|such as athlete's foot, jock itch, and ringworm. This medication||
0433|017|U|is also used to treat a skin condition known as pityriasis (tinea||
0433|018|U|versicolor), a fungal infection that causes a lightening or||
0433|019|U|darkening of the skin of the neck, chest, arms, or legs.||
0433|020|U|Ciclopirox is an antifungal medication that works by stopping the||
0433|021|U|growth of fungus.||
0433|022|B|||
0433|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0433|024|H|thoroughly dry the area to be treated. Apply a thin layer of the||
0433|025|H|medication on and around the affected area and gently rub into||
0433|026|H|the skin as directed by your doctor, usually twice daily. Wash||
0433|027|H|your hands after using unless the area being treated includes the||
0433|028|H|hands. Do not wrap, cover, or bandage the area unless directed to||
0433|029|H|do so by your doctor.||
0433|030|H|   Do not apply the medication in the eyes, nose, or mouth, or||
0433|031|H|inside the vagina. If you do get the medication in those areas,||
0433|032|H|rinse with plenty of water.||
0433|033|H|   Use this medication regularly in order to get the most benefit||
0433|034|H|from it. To help you remember, use it at the same times each day.||
0433|035|H|   Continue to use this medication for the full time prescribed,||
0433|036|H|even if symptoms disappear after a few days. Stopping the||
0433|037|H|medication too early may result in a return of the infection.||
0433|038|H|   Your condition should start to get better within the first||
0433|039|H|week of treatment. Tell your doctor if your condition gets worse||
0433|040|H|or if it does not get better after 2 weeks for pityriasis and||
0433|041|H|after 4 weeks for other fungal skin infections.||
0433|042|B|||
0433|043|S|SIDE EFFECTS:  Burning, redness, or itching at the application||
0433|044|S|site may occur. If any of these effects last or get worse, tell||
0433|045|S|your doctor or pharmacist promptly.||
0433|046|S|   Remember that this medication has been prescribed because your||
0433|047|S|doctor has judged that the benefit to you is greater than the||
0433|048|S|risk of side effects. Many people using this medication do not||
0433|049|S|have serious side effects.||
0433|050|S|   Tell your doctor right away if you have any serious side||
0433|051|S|effects, including: blistering/swelling/oozing at the application||
0433|052|S|site.||
0433|053|S|   A very serious allergic reaction to this drug is rare.||
0433|054|S|However, get medical help right away if you notice any symptoms||
0433|055|S|of a serious allergic reaction, including: rash, itching/swelling||
0433|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0433|057|S|breathing.||
0433|058|S|   This is not a complete list of possible side effects. If you||
0433|059|S|notice other effects not listed above, contact your doctor or||
0433|060|S|pharmacist.||
0433|061|S|   In the US -||
0433|062|S|   Call your doctor for medical advice about side effects. You||
0433|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0433|064|S|www.fda.gov/medwatch.||
0433|065|S|   In Canada - Call your doctor for medical advice about side||
0433|066|S|effects. You may report side effects to Health Canada at||
0433|067|S|1-866-234-2345.||
0433|068|B|||
0433|069|P|PRECAUTIONS:  Before using ciclopirox, tell your doctor or||
0433|070|P|pharmacist if you are allergic to it; or if you have any other||
0433|071|P|allergies. This product may contain inactive ingredients, which||
0433|072|P|can cause allergic reactions or other problems. Talk to your||
0433|073|P|pharmacist for more details.||
0433|074|P|   Before using this medication, tell your doctor or pharmacist||
0433|075|P|your medical history.||
0433|076|P|   Before having surgery, tell your doctors or dentist about all||
0433|077|P|the products you use (including prescription drugs,||
0433|078|P|nonprescription drugs, and herbal products).||
0433|079|P|   During pregnancy, this medication should be used only when||
0433|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
0433|081|P|   It is unknown if this medication passes into breast milk.||
0433|082|P|Consult your doctor before breastfeeding.||
0433|083|B|||
0433|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0433|085|I|medications work or increase your risk for serious side effects.||
0433|086|I|This document does not contain all possible drug interactions.||
0433|087|I|Keep a list of all the products you use (including||
0433|088|I|prescription/nonprescription drugs and herbal products) and share||
0433|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
0433|090|I|the dosage of any medicines without your doctor's approval.||
0433|091|B|||
0433|092|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0433|093|O|has overdosed and has serious symptoms such as passing out or||
0433|094|O|trouble breathing, call 911. Otherwise, call a poison control||
0433|095|O|center right away. US residents can call 1-800-222-1222. Canada||
0433|096|O|residents can call 1-844-764-7669.||
0433|097|B|||
0433|098|N|NOTES:  Do not share this medication with others.||
0433|099|N|   This medication has been prescribed for your current condition||
0433|100|N|only. Do not use it later for another skin infection unless told||
0433|101|N|to do so by your doctor. A different medication may be necessary||
0433|102|N|in that case.||
0433|103|N|   If you are treating athlete's foot, make sure to wear||
0433|104|N|well-fitting, ventilated shoes. Also, change socks at least once||
0433|105|N|daily.||
0433|106|B|||
0433|107|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0433|108|D|If it is near the time of the next dose, skip the missed dose.||
0433|109|D|Use your next dose at the regular time. Do not double the dose to||
0433|110|D|catch up.||
0433|111|B|||
0433|112|R|STORAGE:  Store at room temperature. Keep all medications away||
0433|113|R|from children and pets.||
0433|114|R|   Do not flush medications down the toilet or pour them into a||
0433|115|R|drain unless instructed to do so. Properly discard this product||
0433|116|R|when it is expired or no longer needed. Consult your pharmacist||
0433|117|R|or local waste disposal company.||
0433|118|B|||
0433|119|A|Information last revised November 2024.||
0433|120|A|Copyright(c) 2025 First Databank, Inc.||
0433|121|B|||
0434|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0434|002|Z|does NOT have all possible information about this product. This||
0434|003|Z|information does not assure that this product is safe, effective,||
0434|004|Z|or appropriate for you. This information is not individual||
0434|005|Z|medical advice and does not substitute for the advice of your||
0434|006|Z|health care professional. Always ask your health care||
0434|007|Z|professional for complete information about this product and your||
0434|008|Z|specific health needs.||
0434|009|B|||
0434|010|T|HALOBETASOL - TOPICAL||
0434|011|F|(HAL-oh-BAY-ta-sol)||
0434|012|B|||
0434|013|C|COMMON BRAND NAME(S): Ultravate||
0434|014|B|||
0434|015|U|USES:  This medication is used to treat a variety of skin||
0434|016|U|conditions (such as eczema, dermatitis, psoriasis, rash).||
0434|017|U|Halobetasol reduces the swelling, itching, and redness that can||
0434|018|U|occur in these types of conditions. This medication is a very||
0434|019|U|strong (super-high potency) corticosteroid.||
0434|020|B|||
0434|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0434|022|H|from your pharmacist before you start using halobetasol and each||
0434|023|H|time you get a refill. If you have any questions, ask your doctor||
0434|024|H|or pharmacist.||
0434|025|H|   Use this medication only on the skin. However, do not use it||
0434|026|H|on the face, groin, or underarms unless directed to do so by your||
0434|027|H|doctor.||
0434|028|H|   Apply a thin film of the medication to the affected area and||
0434|029|H|gently rub in as directed by your doctor, usually one to two||
0434|030|H|times a day. Do not cover, bandage, or wrap the area unless||
0434|031|H|directed to do so by your doctor.||
0434|032|H|   After applying the medication, wash your hands unless you are||
0434|033|H|using this medication to treat the hands. If applying this||
0434|034|H|medication near the eyes, avoid getting it in the eyes as this||
0434|035|H|may worsen or cause glaucoma. Also avoid getting this medication||
0434|036|H|in the nose or mouth.||
0434|037|H|   Use this medication only for the condition it was prescribed||
0434|038|H|for. Do not apply more than directed, or use it more often or for||
0434|039|H|longer than prescribed by your doctor.||
0434|040|H|   Tell your doctor if your condition does not get better or if||
0434|041|H|it gets worse.||
0434|042|B|||
0434|043|S|SIDE EFFECTS:  Burning, stinging, itching, dryness or redness may||
0434|044|S|occur when first applied to the skin. This should disappear in a||
0434|045|S|few days as your body adjusts to the medication. If any of these||
0434|046|S|effects last or get worse, notify your doctor or pharmacist||
0434|047|S|promptly.||
0434|048|S|   Remember that this medication has been prescribed because your||
0434|049|S|doctor has judged that the benefit to you is greater than the||
0434|050|S|risk of side effects. Many people using this medication do not||
0434|051|S|have serious side effects.||
0434|052|S|   Tell your doctor right away if you have any serious side||
0434|053|S|effects, including: stretch marks, skin thinning/discoloration,||
0434|054|S|acne, excessive hair growth, small red bumps on the skin||
0434|055|S|(folliculitis).||
0434|056|S|   Skin infections can become worse when using this medication.||
0434|057|S|Notify your doctor promptly if redness, swelling or irritation||
0434|058|S|does not improve.||
0434|059|S|   Rarely, it is possible this medication will be absorbed from||
0434|060|S|the skin into the bloodstream. This can lead to side effects of||
0434|061|S|too much corticosteroid. These side effects are more likely in||
0434|062|S|children, and in people who use this medication for a long time||
0434|063|S|or over large areas of the skin. Tell your doctor right away if||
0434|064|S|any of the following side effects occur: unusual/extreme||
0434|065|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0434|066|S|thirst/urination, vision problems.||
0434|067|S|   A very serious allergic reaction to this drug is rare.||
0434|068|S|However, get medical help right away if you notice any symptoms||
0434|069|S|of a serious allergic reaction, including: rash, itching/swelling||
0434|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0434|071|S|breathing.||
0434|072|S|   This is not a complete list of possible side effects. If you||
0434|073|S|notice other effects not listed above, contact your doctor or||
0434|074|S|pharmacist.||
0434|075|S|   In the US -||
0434|076|S|   Call your doctor for medical advice about side effects. You||
0434|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0434|078|S|www.fda.gov/medwatch.||
0434|079|S|   In Canada - Call your doctor for medical advice about side||
0434|080|S|effects. You may report side effects to Health Canada at||
0434|081|S|1-866-234-2345.||
0434|082|B|||
0434|083|P|PRECAUTIONS:  Before using halobetasol, tell your doctor or||
0434|084|P|pharmacist if you are allergic to it; or to other corticosteroids||
0434|085|P|(such as hydrocortisone, prednisone); or if you have any other||
0434|086|P|allergies. This product may contain inactive ingredients, which||
0434|087|P|can cause allergic reactions or other problems. Talk to your||
0434|088|P|pharmacist for more details.||
0434|089|P|   Before using this medication, tell your doctor or pharmacist||
0434|090|P|your medical history, especially of: poor blood circulation,||
0434|091|P|immune system problems, certain skin conditions (rosacea,||
0434|092|P|perioral dermatitis).||
0434|093|P|   Do not use if there is an infection or sore present in the||
0434|094|P|area to be treated.||
0434|095|P|   Rarely, using corticosteroid medications for a long time or||
0434|096|P|over large areas of skin can make it more difficult for your body||
0434|097|P|to respond to physical stress. Before having surgery or emergency||
0434|098|P|treatment, or if you get a serious illness/injury, tell your||
0434|099|P|doctor or dentist that you are using this medication or have used||
0434|100|P|this medication within the past few months.||
0434|101|P|   Though it is unlikely, this medication may temporarily slow||
0434|102|P|down a child's growth if used for a long time. See the doctor||
0434|103|P|regularly so your child's height can be checked.||
0434|104|P|   During pregnancy, this medication should be used only when||
0434|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
0434|106|P|   It is unknown if this drug passes into breast milk when||
0434|107|P|applied to the skin. Similar medications pass into breast milk||
0434|108|P|when taken by mouth. Consult your doctor before breastfeeding.||
0434|109|B|||
0434|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0434|111|I|medications work or increase your risk for serious side effects.||
0434|112|I|This document does not contain all possible drug interactions.||
0434|113|I|Keep a list of all the products you use (including||
0434|114|I|prescription/nonprescription drugs and herbal products) and share||
0434|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
0434|116|I|the dosage of any medicines without your doctor's approval.||
0434|117|B|||
0434|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0434|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0434|120|O|poison control center right away. US residents can call||
0434|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0434|122|O|medication may be harmful if swallowed.||
0434|123|B|||
0434|124|N|NOTES:  Do not share this medication with others.||
0434|125|N|   This medication has been prescribed for your current condition||
0434|126|N|only. Do not use it later for other skin problems unless your||
0434|127|N|doctor tells you to. A different medication may be necessary in||
0434|128|N|those cases.||
0434|129|N|   Lab and/or medical tests (such as adrenal gland function) may||
0434|130|N|be done while you are using this medication, especially if you||
0434|131|N|use this drug for a long time or apply it over large areas of the||
0434|132|N|body. Keep all medical and lab appointments.||
0434|133|B|||
0434|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0434|135|D|If it is near the time of the next dose, skip the missed dose.||
0434|136|D|Use your next dose at the regular time. Do not double the dose to||
0434|137|D|catch up.||
0434|138|B|||
0434|139|R|STORAGE:  Store at room temperature. Keep all medications away||
0434|140|R|from children and pets.||
0434|141|R|   Do not flush medications down the toilet or pour them into a||
0434|142|R|drain unless instructed to do so. Properly discard this product||
0434|143|R|when it is expired or no longer needed. Consult your pharmacist||
0434|144|R|or local waste disposal company.||
0434|145|B|||
0434|146|A|Information last revised May 2024.||
0434|147|A|Copyright(c) 2025 First Databank, Inc.||
0434|148|B|||
0436|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0436|002|Z|does NOT have all possible information about this product. This||
0436|003|Z|information does not assure that this product is safe, effective,||
0436|004|Z|or appropriate for you. This information is not individual||
0436|005|Z|medical advice and does not substitute for the advice of your||
0436|006|Z|health care professional. Always ask your health care||
0436|007|Z|professional for complete information about this product and your||
0436|008|Z|specific health needs.||
0436|009|B|||
0436|010|T|SULFACETAMIDE/PREDNISOLONE DROPS - OPHTHALMIC||
0436|011|F|(SUL-fa-SEET-a-mide/pred-NIS-oh-loan)||
0436|012|B|||
0436|013|C|COMMON BRAND NAME(S): Blephamide, Vasocidin||
0436|014|B|||
0436|015|U|USES:  This medication is used to prevent or treat eye infections||
0436|016|U|and to treat swelling in the eye. This product contains an||
0436|017|U|antibiotic (sulfacetamide) that stops the growth of bacteria and||
0436|018|U|a corticosteroid (prednisolone) that reduces inflammation.||
0436|019|U|   This medication treats only bacterial eye infections. It will||
0436|020|U|not work for other types of eye infections. Unnecessary use or||
0436|021|U|overuse of any antibiotic can lead to its decreased||
0436|022|U|effectiveness.||
0436|023|B|||
0436|024|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0436|025|H|directed by your doctor, usually every 4 hours.||
0436|026|H|   To apply eye drops, wash your hands first. If your product is||
0436|027|H|a suspension, shake the suspension well before each dose. To||
0436|028|H|avoid contamination, do not touch the dropper tip or let it touch||
0436|029|H|your eye or any other surface.||
0436|030|H|   Before using, check this product for discoloration. If it has||
0436|031|H|darkened in color, do not use the liquid.||
0436|032|H|   Do not wear contact lenses while you are using this medicine.||
0436|033|H|Sterilize contact lenses according to manufacturer's directions||
0436|034|H|and check with your doctor before using them.||
0436|035|H|   Tilt your head back, look upward and pull down the lower||
0436|036|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0436|037|H|and place one drop into it. Look downward and gently close your||
0436|038|H|eyes for 1 to 2 minutes. Place one finger at the corner of your||
0436|039|H|eye (near the nose) and apply gentle pressure. This will prevent||
0436|040|H|the medication from draining out. Try not to blink and do not rub||
0436|041|H|your eye. Repeat these steps for your other eye if so directed,||
0436|042|H|and if your dose is for more than 1 drop.||
0436|043|H|   Do not rinse the dropper. Replace the dropper cap after each||
0436|044|H|use.||
0436|045|H|   If you are using another kind of eye medication (such as drops||
0436|046|H|or ointments), wait at least 5 minutes before applying other||
0436|047|H|medications. Use eye drops before eye ointments to allow the eye||
0436|048|H|drops to enter the eye.||
0436|049|H|   Wait several minutes for your vision to clear before driving||
0436|050|H|or operating machinery.||
0436|051|H|   Use this medication regularly in order to get the most benefit||
0436|052|H|from it. Continue to use this medication for the full time||
0436|053|H|prescribed, even if symptoms disappear after a few days. Stopping||
0436|054|H|the medication too early may result in a return of the infection.||
0436|055|H|   Do not use this medication for longer than prescribed. If you||
0436|056|H|use it regularly for an extended period of time, do not suddenly||
0436|057|H|stop using it without consulting your doctor. Your dosage may||
0436|058|H|need to be gradually decreased.||
0436|059|H|   Tell your doctor if your condition does not get better after 2||
0436|060|H|days.||
0436|061|B|||
0436|062|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
0436|063|S|eyes for a minute or two when applied. Eye discomfort, dry eyes,||
0436|064|S|tearing, itching, or redness may occur. If any of these effects||
0436|065|S|last or get worse, notify your doctor or pharmacist promptly.||
0436|066|S|   Remember that this medication has been prescribed because your||
0436|067|S|doctor has judged that the benefit to you is greater than the||
0436|068|S|risk of side effects. Many people using this medication do not||
0436|069|S|have serious side effects.||
0436|070|S|   Use of this medication for prolonged or repeated periods may||
0436|071|S|result in a new type of eye infection (such as viral, fungal). Do||
0436|072|S|not use it for longer than prescribed. Contact your doctor if you||
0436|073|S|notice new or worsening symptoms.||
0436|074|S|   Tell your doctor right away if you have any serious side||
0436|075|S|effects, including: vision changes, eye pain, staining of the||
0436|076|S|eyes, signs of infection (such as sore throat that doesn't go||
0436|077|S|away, fever, chills), easy bleeding/bruising, yellowing of the||
0436|078|S|eyes/skin, dark urine.||
0436|079|S|   A very serious allergic reaction to this drug is rare.||
0436|080|S|However, get medical help right away if you notice any symptoms||
0436|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0436|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0436|083|S|breathing.||
0436|084|S|   This is not a complete list of possible side effects. If you||
0436|085|S|notice other effects not listed above, contact your doctor or||
0436|086|S|pharmacist.||
0436|087|S|   In the US -||
0436|088|S|   Call your doctor for medical advice about side effects. You||
0436|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0436|090|S|www.fda.gov/medwatch.||
0436|091|S|   In Canada - Call your doctor for medical advice about side||
0436|092|S|effects. You may report side effects to Health Canada at||
0436|093|S|1-866-234-2345.||
0436|094|B|||
0436|095|P|PRECAUTIONS:  Before using sulfacetamide/prednisolone, tell your||
0436|096|P|doctor or pharmacist if you are allergic to it; or to sulfa drugs||
0436|097|P|(such as sulfamethoxazole), corticosteroids (such as||
0436|098|P|hydrocortisone, prednisone); or if you have any other allergies.||
0436|099|P|This product may contain inactive ingredients (such as||
0436|100|P|preservatives like benzalkonium chloride), which can cause||
0436|101|P|allergic reactions or other problems. Talk to your pharmacist for||
0436|102|P|more details.||
0436|103|P|   Before using this medication, tell your doctor or pharmacist||
0436|104|P|your medical history, especially of: eye problems (such as||
0436|105|P|glaucoma, severely dry eyes), eye surgeries (such as cataract||
0436|106|P|surgery), diabetes.||
0436|107|P|   After you apply this drug, your vision may become temporarily||
0436|108|P|blurred or unstable. Do not drive, use machinery, or do anything||
0436|109|P|that needs clear vision until you can do it safely.||
0436|110|P|   During pregnancy, this medication should be used only when||
0436|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
0436|112|P|   It is unknown if the medications in this product pass into||
0436|113|P|breast milk. Consult your doctor before breastfeeding.||
0436|114|B|||
0436|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0436|116|I|medications work or increase your risk for serious side effects.||
0436|117|I|This document does not contain all possible drug interactions.||
0436|118|I|Keep a list of all the products you use (including||
0436|119|I|prescription/nonprescription drugs and herbal products) and share||
0436|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
0436|121|I|the dosage of any medicines without your doctor's approval.||
0436|122|I|   Some products that may interact with this drug are:||
0436|123|I|gentamicin, certain local anesthetics (such as tetracaine),||
0436|124|I|preparations that contain silver.||
0436|125|B|||
0436|126|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0436|127|O|has overdosed and has serious symptoms such as passing out or||
0436|128|O|trouble breathing, call 911. Otherwise, call a poison control||
0436|129|O|center right away. US residents can call 1-800-222-1222. Canada||
0436|130|O|residents can call 1-844-764-7669.||
0436|131|B|||
0436|132|N|NOTES:  Do not share this medication with others.||
0436|133|N|   This medication has been prescribed for your current condition||
0436|134|N|only. Throw away the unused medication after treatment is||
0436|135|N|completed. Do not use it later for another infection unless your||
0436|136|N|doctor tells you to.||
0436|137|N|   If used for a long time (more than 10 days), lab and/or||
0436|138|N|medical tests (such as eye exams) should be done while you are||
0436|139|N|using this medication. Keep all medical and lab appointments.||
0436|140|N|Consult your doctor for more details.||
0436|141|B|||
0436|142|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0436|143|D|If it is near the time of the next dose, skip the missed dose.||
0436|144|D|Use your next dose at the regular time. Do not double the dose to||
0436|145|D|catch up.||
0436|146|B|||
0436|147|R|STORAGE:  Store at room temperature away from light. Do not||
0436|148|R|freeze. Do not use the solution if the color has darkened. Keep||
0436|149|R|all medications away from children and pets.||
0436|150|R|   Do not flush medications down the toilet or pour them into a||
0436|151|R|drain unless instructed to do so. Properly discard this product||
0436|152|R|when it is expired or no longer needed. Consult your pharmacist||
0436|153|R|or local waste disposal company.||
0436|154|B|||
0436|155|A|Information last revised April 2025.||
0436|156|A|Copyright(c) 2025 First Databank, Inc.||
0436|157|B|||
0437|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0437|002|Z|does NOT have all possible information about this product. This||
0437|003|Z|information does not assure that this product is safe, effective,||
0437|004|Z|or appropriate for you. This information is not individual||
0437|005|Z|medical advice and does not substitute for the advice of your||
0437|006|Z|health care professional. Always ask your health care||
0437|007|Z|professional for complete information about this product and your||
0437|008|Z|specific health needs.||
0437|009|B|||
0437|010|T|FUSIDIC ACID/HYDROCORTISONE - TOPICAL||
0437|011|F|(fue-SID-ik AS-id/HYE-droe-KOR-ti-sone)||
0437|012|B|||
0437|013|U|USES:  This medication is used to treat certain skin diseases||
0437|014|U|(such as atopic dermatitis). It works by stopping the growth of||
0437|015|U|certain bacteria and reducing redness, itching, crusting, and||
0437|016|U|swelling of the skin sores. This medication is a combination of||
0437|017|U|an antibiotic (fusidic acid) and a corticosteroid||
0437|018|U|(hydrocortisone).||
0437|019|U|   This medication treats only certain bacterial infections. It||
0437|020|U|will not work for other infections such as viral or fungal||
0437|021|U|infections. Unnecessary use or overuse of any antibiotic can lead||
0437|022|U|to its decreased effectiveness.||
0437|023|B|||
0437|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0437|025|H|from your pharmacist before you start using this product and each||
0437|026|H|time you get a refill. If you have any questions, ask your doctor||
0437|027|H|or pharmacist.||
0437|028|H|   Clean and pat dry the affected skin areas before applying the||
0437|029|H|medication. Gently massage a small amount into the affected areas||
0437|030|H|as directed by your doctor, usually three times daily. Do not||
0437|031|H|bandage, wrap, or cover the area with an occlusive (plastic)||
0437|032|H|dressing unless directed to do so by your doctor.||
0437|033|H|   If you are using this medication on the face, avoid applying||
0437|034|H|it in or near the eye to prevent irritation or serious side||
0437|035|H|effects (such as cataracts, glaucoma) that could occur with||
0437|036|H|extended use.||
0437|037|H|   Do not apply to a larger area or use this drug more often or||
0437|038|H|for longer than prescribed. Your condition will not improve any||
0437|039|H|faster, and your risk of side effects will increase.||
0437|040|H|   Tell your doctor if your condition lasts or gets worse after||
0437|041|H|14 days.||
0437|042|B|||
0437|043|S|SIDE EFFECTS:  Dryness, mild irritation, burning, or redness may||
0437|044|S|occur. If any of these effects last or get worse, notify your||
0437|045|S|doctor or pharmacist promptly.||
0437|046|S|   Remember that this medication has been prescribed because your||
0437|047|S|doctor has judged that the benefit to you is greater than the||
0437|048|S|risk of side effects. Many people using this medication do not||
0437|049|S|have serious side effects.||
0437|050|S|   Use of this medication for prolonged or repeated periods may||
0437|051|S|result in skin discoloration/thinning or a new infection (such as||
0437|052|S|a fungal infection). Contact your doctor if you notice signs of a||
0437|053|S|new infection (such as new or worsening redness/irritation).||
0437|054|S|   A very serious allergic reaction to this drug is rare.||
0437|055|S|However, get medical help right away if you notice any symptoms||
0437|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0437|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0437|058|S|breathing.||
0437|059|S|   This is not a complete list of possible side effects. If you||
0437|060|S|notice other effects not listed above, contact your doctor or||
0437|061|S|pharmacist.||
0437|062|S|   In the US -||
0437|063|S|   Call your doctor for medical advice about side effects. You||
0437|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0437|065|S|www.fda.gov/medwatch.||
0437|066|S|   In Canada - Call your doctor for medical advice about side||
0437|067|S|effects. You may report side effects to Health Canada at||
0437|068|S|1-866-234-2345.||
0437|069|B|||
0437|070|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0437|071|P|pharmacist if you are allergic to fusidic acid, hydrocortisone;||
0437|072|P|or if you have any other allergies. This product may contain||
0437|073|P|inactive ingredients, which can cause allergic reactions or other||
0437|074|P|problems. Talk to your pharmacist for more details.||
0437|075|P|   Before using this medication, tell your doctor or pharmacist||
0437|076|P|your medical history.||
0437|077|P|   Before having surgery, tell your doctor or dentist about all||
0437|078|P|the products you use (including prescription drugs,||
0437|079|P|nonprescription drugs, and herbal products).||
0437|080|P|   Children may be more sensitive to the effects of too much||
0437|081|P|corticosteroid medication. Consult your doctor for more details.||
0437|082|P|   During pregnancy, this medication should be used only when||
0437|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
0437|084|P|   It is unknown if this medication passes into breast milk.||
0437|085|P|Consult your doctor before breastfeeding.||
0437|086|B|||
0437|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0437|088|I|medications work or increase your risk for serious side effects.||
0437|089|I|This document does not contain all possible drug interactions.||
0437|090|I|Keep a list of all the products you use (including||
0437|091|I|prescription/nonprescription drugs and herbal products) and share||
0437|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
0437|093|I|the dosage of any medicines without your doctor's approval.||
0437|094|B|||
0437|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0437|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0437|097|O|poison control center right away. US residents can call||
0437|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0437|099|O|medication may be harmful if swallowed.||
0437|100|B|||
0437|101|N|NOTES:  Do not share this medication with others.||
0437|102|N|   This medication has been prescribed for your current condition||
0437|103|N|only. Do not use it later for another condition unless told to do||
0437|104|N|so by your doctor. A different medication may be necessary in||
0437|105|N|those cases.||
0437|106|B|||
0437|107|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0437|108|D|If it is near the time of the next dose, skip the missed dose.||
0437|109|D|Use your next dose at the regular time. Do not double the dose to||
0437|110|D|catch up.||
0437|111|B|||
0437|112|R|STORAGE:  Store at room temperature. Keep all medications away||
0437|113|R|from children and pets.||
0437|114|R|   Do not flush medications down the toilet or pour them into a||
0437|115|R|drain unless instructed to do so. Properly discard this product||
0437|116|R|when it is expired or no longer needed. Consult your pharmacist||
0437|117|R|or local waste disposal company.||
0437|118|B|||
0437|119|A|Information last revised January 2025.||
0437|120|A|Copyright(c) 2025 First Databank, Inc.||
0437|121|B|||
0438|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0438|002|Z|does NOT have all possible information about this product. This||
0438|003|Z|information does not assure that this product is safe, effective,||
0438|004|Z|or appropriate for you. This information is not individual||
0438|005|Z|medical advice and does not substitute for the advice of your||
0438|006|Z|health care professional. Always ask your health care||
0438|007|Z|professional for complete information about this product and your||
0438|008|Z|specific health needs.||
0438|009|B|||
0438|010|T|METHYLPHENIDATE CHEWABLE TABLET - ORAL||
0438|011|F|(METH-il-FEN-i-date)||
0438|012|B|||
0438|013|C|COMMON BRAND NAME(S): Methylin||
0438|014|B|||
0438|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
0438|016|W|serious (possibly fatal) heart and blood pressure problems.||
0438|017|W|   This medication can be habit-forming and should be used||
0438|018|W|cautiously by people who have mental/mood disorders or a||
0438|019|W|substance use disorder (such as overuse of or addiction to||
0438|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
0438|021|W|you have a personal or family history of a substance use||
0438|022|W|disorder. Do not increase your dose, use it more often, or use it||
0438|023|W|for a longer time or in a different way than prescribed. Doing so||
0438|024|W|may result in a decrease in the effect of this drug, drug||
0438|025|W|dependence, or abnormal thoughts/behavior.||
0438|026|W|   Your doctor may monitor you for a while after the medication||
0438|027|W|is stopped, especially if you have taken this drug for a long||
0438|028|W|time or in high doses. (See also How to Use section.)||
0438|029|B|||
0438|030|U|USES:  This medication is used to treat attention deficit||
0438|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
0438|032|U|of certain natural substances in the brain. Methylphenidate||
0438|033|U|belongs to a class of drugs known as stimulants. It can help||
0438|034|U|increase your ability to pay attention, stay focused on an||
0438|035|U|activity, and control behavior problems. It may also help you to||
0438|036|U|organize your tasks and improve listening skills.||
0438|037|U|   This medication is also used to treat a certain sleep disorder||
0438|038|U|(narcolepsy).||
0438|039|B|||
0438|040|H|HOW TO USE:  Read the Medication Guide provided by your||
0438|041|H|pharmacist before you start taking methylphenidate and each time||
0438|042|H|you get a refill. If you have any questions, ask your doctor or||
0438|043|H|pharmacist.||
0438|044|H|   Take this medication by mouth as directed by your doctor,||
0438|045|H|usually 2 or 3 times a day. This medication is best taken 30 to||
0438|046|H|45 minutes before a meal. Chew the tablets thoroughly before||
0438|047|H|swallowing. Follow with at least a full glass of water or other||
0438|048|H|liquid (8 ounces/240 milliliters) to lessen the chance of||
0438|049|H|choking.||
0438|050|H|   If you have stomach upset, you may take this medication with||
0438|051|H|or after a meal or snack. Taking this medication late in the day||
0438|052|H|may cause trouble sleeping (insomnia).||
0438|053|H|   Take this medication regularly to get the most benefit from||
0438|054|H|it. To help you remember, take it at the same times each day.||
0438|055|H|   The dosage is based on your medical condition and response to||
0438|056|H|treatment. Your doctor may direct you to gradually increase or||
0438|057|H|decrease your dose. Also, if you have used it for a long time, do||
0438|058|H|not suddenly stop using this drug without consulting your doctor.||
0438|059|H|   If you suddenly stop using this medication, you may have||
0438|060|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
0438|061|H|other mental/mood changes). To help prevent withdrawal, your||
0438|062|H|doctor may lower your dose slowly. Withdrawal is more likely if||
0438|063|H|you have used methylphenidate for a long time or in high doses.||
0438|064|H|Tell your doctor or pharmacist right away if you have withdrawal.||
0438|065|H|   When used for a long time, this medication may not work as||
0438|066|H|well. Talk with your doctor if this medication stops working||
0438|067|H|well.||
0438|068|H|   Though it helps many people, this medication may sometimes||
0438|069|H|cause addiction. This risk may be higher if you have a substance||
0438|070|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0438|071|H|Take this medication exactly as prescribed to lower the risk of||
0438|072|H|addiction. Ask your doctor or pharmacist for more details.||
0438|073|H|   Tell your doctor if your condition does not get better or if||
0438|074|H|it gets worse.||
0438|075|B|||
0438|076|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
0438|077|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
0438|078|S|If any of these effects last or get worse, tell your doctor or||
0438|079|S|pharmacist promptly.||
0438|080|S|   Remember that this medication has been prescribed because your||
0438|081|S|doctor has judged that the benefit to you is greater than the||
0438|082|S|risk of side effects. Many people using this medication do not||
0438|083|S|have serious side effects.||
0438|084|S|   This medication may raise your blood pressure. Check your||
0438|085|S|blood pressure regularly and tell your doctor if the results are||
0438|086|S|high.||
0438|087|S|   Tell your doctor right away if you have any serious side||
0438|088|S|effects, including: signs of blood flow problems in the fingers||
0438|089|S|or toes (such as coldness, numbness, pain, or skin color||
0438|090|S|changes), unusual wounds on the fingers or toes,||
0438|091|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
0438|092|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
0438|093|S|thoughts of suicide), uncontrolled muscle movements (such as||
0438|094|S|twitching, shaking), sudden outbursts of words/sounds that are||
0438|095|S|hard to control, vision changes (such as blurred vision).||
0438|096|S|   Get medical help right away if you have any very serious side||
0438|097|S|effects, including: fainting, seizure, symptoms of a heart attack||
0438|098|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
0438|099|S|sweating), symptoms of a stroke (such as weakness on one side of||
0438|100|S|the body, trouble speaking, sudden vision changes, confusion).||
0438|101|S|   Rarely, males (including young boys and teens) may have a||
0438|102|S|painful or prolonged erection lasting 4 or more hours while using||
0438|103|S|this medication. Caregivers/parents should also be watchful for||
0438|104|S|this serious side effect in boys. If a painful or prolonged||
0438|105|S|erection occurs, stop using this drug and get medical help right||
0438|106|S|away, or permanent problems could occur. Ask your doctor or||
0438|107|S|pharmacist for more details.||
0438|108|S|   A very serious allergic reaction to this drug is rare.||
0438|109|S|However, get medical help right away if you notice any symptoms||
0438|110|S|of a serious allergic reaction, including: rash, itching/swelling||
0438|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0438|112|S|breathing.||
0438|113|S|   This is not a complete list of possible side effects. If you||
0438|114|S|notice other effects not listed above, contact your doctor or||
0438|115|S|pharmacist.||
0438|116|S|   In the US -||
0438|117|S|   Call your doctor for medical advice about side effects. You||
0438|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0438|119|S|www.fda.gov/medwatch.||
0438|120|S|   In Canada - Call your doctor for medical advice about side||
0438|121|S|effects. You may report side effects to Health Canada at||
0438|122|S|1-866-234-2345.||
0438|123|B|||
0438|124|P|PRECAUTIONS:  See also Warning section.||
0438|125|P|   Before taking methylphenidate, tell your doctor or pharmacist||
0438|126|P|if you are allergic to it; or to dexmethylphenidate; or if you||
0438|127|P|have any other allergies. This product may contain inactive||
0438|128|P|ingredients, which can cause allergic reactions or other||
0438|129|P|problems. Talk to your pharmacist for more details.||
0438|130|P|   Before using this medication, tell your doctor or pharmacist||
0438|131|P|your medical history, especially of: high blood pressure, blood||
0438|132|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
0438|133|P|problems (such as irregular heartbeat, heart failure, previous||
0438|134|P|heart attack, problems with heart structure), family history of||
0438|135|P|heart problems (such as sudden cardiac death, irregular||
0438|136|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
0438|137|P|agitation), personal/family history of mental/mood disorders||
0438|138|P|(such as bipolar disorder, depression, psychosis, suicidal||
0438|139|P|thoughts), personal/family history of uncontrolled muscle||
0438|140|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
0438|141|P|(hyperthyroidism), seizure disorder.||
0438|142|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0438|143|P|can make you more dizzy. Do not drive, use machinery, or do||
0438|144|P|anything that needs alertness until you can do it safely. Limit||
0438|145|P|alcoholic beverages. Talk to your doctor if you are using||
0438|146|P|marijuana (cannabis).||
0438|147|P|   This medication may contain aspartame. If you have||
0438|148|P|phenylketonuria (PKU) or any other condition that requires you to||
0438|149|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
0438|150|P|doctor or pharmacist about using this medication safely.||
0438|151|P|   Before having surgery, tell your doctor or dentist about all||
0438|152|P|the products you use (including prescription drugs,||
0438|153|P|nonprescription drugs, and herbal products).||
0438|154|P|   If used for a long time, this drug may affect a child's growth||
0438|155|P|rate, weight, and final adult height. To reduce the risk, the||
0438|156|P|doctor may recommend briefly stopping the medication from time to||
0438|157|P|time. Check the child's weight and height regularly, and consult||
0438|158|P|your doctor or pharmacist for more details.||
0438|159|P|   Older adults may be more sensitive to the side effects of this||
0438|160|P|drug, especially trouble sleeping, weight loss, or chest pain.||
0438|161|P|   During pregnancy, methylphenidate should be used only when||
0438|162|P|clearly needed. Discuss the risks and benefits with your doctor.||
0438|163|P|   This medication passes into breast milk. Consult your doctor||
0438|164|P|before breastfeeding.||
0438|165|B|||
0438|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0438|167|I|medications work or increase your risk for serious side effects.||
0438|168|I|This document does not contain all possible drug interactions.||
0438|169|I|Keep a list of all the products you use (including||
0438|170|I|prescription/nonprescription drugs and herbal products) and share||
0438|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
0438|172|I|the dosage of any medicines without your doctor's approval.||
0438|173|I|   Taking MAO inhibitors with this medication may cause a serious||
0438|174|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0438|175|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0438|176|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0438|177|I|selegiline, tranylcypromine) during treatment with this||
0438|178|I|medication. Most MAO inhibitors should also not be taken for two||
0438|179|I|weeks before treatment with this medication. Ask your doctor when||
0438|180|I|to start or stop taking this medication.||
0438|181|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
0438|182|I|use medications containing dexmethylphenidate while using||
0438|183|I|methylphenidate.||
0438|184|I|   This medication may interfere with certain medical/lab tests||
0438|185|I|(such as brain scan for Parkinson's disease), possibly causing||
0438|186|I|false test results. Make sure lab personnel and all your doctors||
0438|187|I|know you use this drug.||
0438|188|B|||
0438|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0438|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0438|191|O|poison control center right away. US residents can call||
0438|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0438|193|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
0438|194|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
0438|195|O|loss of consciousness.||
0438|196|B|||
0438|197|N|NOTES:  Do not share this medication with others. Sharing it is||
0438|198|N|against the law.||
0438|199|N|   Lab and/or medical tests (such as blood pressure, complete||
0438|200|N|blood count, height/weight monitoring in children) may be done||
0438|201|N|while you are taking this medication. Keep all medical and lab||
0438|202|N|appointments. Consult your doctor for more details.||
0438|203|N|   There are different brands and forms of this medication||
0438|204|N|available. Not all have the same effects. Do not change brands or||
0438|205|N|forms without consulting your doctor or pharmacist.||
0438|206|B|||
0438|207|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0438|208|D|remember. If it is near bedtime or near the time of the next||
0438|209|D|dose, skip the missed dose. Take your next dose at the regular||
0438|210|D|time. Do not double the dose to catch up.||
0438|211|B|||
0438|212|R|STORAGE:  Store at room temperature away from light and moisture.||
0438|213|R|Do not store in the bathroom. Keep all medications away from||
0438|214|R|children and pets.||
0438|215|R|   Do not flush medications down the toilet or pour them into a||
0438|216|R|drain unless instructed to do so. Properly discard this product||
0438|217|R|when it is expired or no longer needed. Consult your pharmacist||
0438|218|R|or local waste disposal company.||
0438|219|B|||
0438|220|A|Information last revised October 2024.||
0438|221|A|Copyright(c) 2025 First Databank, Inc.||
0438|222|B|||
0439|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0439|002|Z|does NOT have all possible information about this product. This||
0439|003|Z|information does not assure that this product is safe, effective,||
0439|004|Z|or appropriate for you. This information is not individual||
0439|005|Z|medical advice and does not substitute for the advice of your||
0439|006|Z|health care professional. Always ask your health care||
0439|007|Z|professional for complete information about this product and your||
0439|008|Z|specific health needs.||
0439|009|B|||
0439|010|T|METHYLPHENIDATE SOLUTION - ORAL||
0439|011|F|(METH-il-FEN-i-date)||
0439|012|B|||
0439|013|C|COMMON BRAND NAME(S): Methylin||
0439|014|B|||
0439|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
0439|016|W|serious (possibly fatal) heart and blood pressure problems.||
0439|017|W|   This medication can be habit-forming and should be used||
0439|018|W|cautiously by people who have mental/mood disorders or a||
0439|019|W|substance use disorder (such as overuse of or addiction to||
0439|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
0439|021|W|you have a personal or family history of a substance use||
0439|022|W|disorder. Do not increase your dose, use it more often, or use it||
0439|023|W|for a longer time or in a different way than prescribed. Doing so||
0439|024|W|may result in a decrease in the effect of this drug, drug||
0439|025|W|dependence, or abnormal thoughts/behavior.||
0439|026|W|   Your doctor may monitor you for a while after the medication||
0439|027|W|is stopped, especially if you have taken this drug for a long||
0439|028|W|time or in high doses. (See also How to Use section.)||
0439|029|B|||
0439|030|U|USES:  This medication is used to treat attention deficit||
0439|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
0439|032|U|of certain natural substances in the brain. Methylphenidate||
0439|033|U|belongs to a class of drugs known as stimulants. It can help||
0439|034|U|increase your ability to pay attention, stay focused on an||
0439|035|U|activity, and control behavior problems. It may also help you to||
0439|036|U|organize your tasks and improve listening skills.||
0439|037|U|   This medication is also used to treat a certain sleep disorder||
0439|038|U|(narcolepsy).||
0439|039|B|||
0439|040|H|HOW TO USE:  Read the Medication Guide provided by your||
0439|041|H|pharmacist before you start taking methylphenidate and each time||
0439|042|H|you get a refill. If you have any questions, ask your doctor or||
0439|043|H|pharmacist.||
0439|044|H|   Take this medication by mouth as directed by your doctor,||
0439|045|H|usually 2 or 3 times a day. This medication is best taken 30 to||
0439|046|H|45 minutes before a meal. Carefully measure the dose using a||
0439|047|H|special measuring device/spoon. Do not use a household spoon||
0439|048|H|because you may not get the correct dose.||
0439|049|H|   If you have stomach upset, you may take this medication with||
0439|050|H|or after a meal or snack. Taking this medication late in the day||
0439|051|H|may cause trouble sleeping (insomnia).||
0439|052|H|   Take this medication regularly to get the most benefit from||
0439|053|H|it. To help you remember, take it at the same times each day.||
0439|054|H|   The dosage is based on your medical condition and response to||
0439|055|H|treatment. Your doctor may direct you to gradually increase or||
0439|056|H|decrease your dose. Also, if you have used it for a long time, do||
0439|057|H|not suddenly stop using this drug without consulting your doctor.||
0439|058|H|   If you suddenly stop using this medication, you may have||
0439|059|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
0439|060|H|other mental/mood changes). To help prevent withdrawal, your||
0439|061|H|doctor may lower your dose slowly. Withdrawal is more likely if||
0439|062|H|you have used methylphenidate for a long time or in high doses.||
0439|063|H|Tell your doctor or pharmacist right away if you have withdrawal.||
0439|064|H|   When used for a long time, this medication may not work as||
0439|065|H|well. Talk with your doctor if this medication stops working||
0439|066|H|well.||
0439|067|H|   Though it helps many people, this medication may sometimes||
0439|068|H|cause addiction. This risk may be higher if you have a substance||
0439|069|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0439|070|H|Take this medication exactly as prescribed to lower the risk of||
0439|071|H|addiction. Ask your doctor or pharmacist for more details.||
0439|072|H|   Tell your doctor if your condition does not get better or if||
0439|073|H|it gets worse.||
0439|074|B|||
0439|075|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
0439|076|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
0439|077|S|If any of these effects last or get worse, tell your doctor or||
0439|078|S|pharmacist promptly.||
0439|079|S|   Remember that this medication has been prescribed because your||
0439|080|S|doctor has judged that the benefit to you is greater than the||
0439|081|S|risk of side effects. Many people using this medication do not||
0439|082|S|have serious side effects.||
0439|083|S|   This medication may raise your blood pressure. Check your||
0439|084|S|blood pressure regularly and tell your doctor if the results are||
0439|085|S|high.||
0439|086|S|   Tell your doctor right away if you have any serious side||
0439|087|S|effects, including: signs of blood flow problems in the fingers||
0439|088|S|or toes (such as coldness, numbness, pain, or skin color||
0439|089|S|changes), unusual wounds on the fingers or toes,||
0439|090|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
0439|091|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
0439|092|S|thoughts of suicide), uncontrolled muscle movements (such as||
0439|093|S|twitching, shaking), sudden outbursts of words/sounds that are||
0439|094|S|hard to control, vision changes (such as blurred vision).||
0439|095|S|   Get medical help right away if you have any very serious side||
0439|096|S|effects, including: fainting, seizure, symptoms of a heart attack||
0439|097|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
0439|098|S|sweating), symptoms of a stroke (such as weakness on one side of||
0439|099|S|the body, trouble speaking, sudden vision changes, confusion).||
0439|100|S|   Rarely, males (including young boys and teens) may have a||
0439|101|S|painful or prolonged erection lasting 4 or more hours while using||
0439|102|S|this medication. Caregivers/parents should also be watchful for||
0439|103|S|this serious side effect in boys. If a painful or prolonged||
0439|104|S|erection occurs, stop using this drug and get medical help right||
0439|105|S|away, or permanent problems could occur. Ask your doctor or||
0439|106|S|pharmacist for more details.||
0439|107|S|   A very serious allergic reaction to this drug is rare.||
0439|108|S|However, get medical help right away if you notice any symptoms||
0439|109|S|of a serious allergic reaction, including: rash, itching/swelling||
0439|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0439|111|S|breathing.||
0439|112|S|   This is not a complete list of possible side effects. If you||
0439|113|S|notice other effects not listed above, contact your doctor or||
0439|114|S|pharmacist.||
0439|115|S|   In the US -||
0439|116|S|   Call your doctor for medical advice about side effects. You||
0439|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0439|118|S|www.fda.gov/medwatch.||
0439|119|S|   In Canada - Call your doctor for medical advice about side||
0439|120|S|effects. You may report side effects to Health Canada at||
0439|121|S|1-866-234-2345.||
0439|122|B|||
0439|123|P|PRECAUTIONS:  See also Warning section.||
0439|124|P|   Before taking methylphenidate, tell your doctor or pharmacist||
0439|125|P|if you are allergic to it; or to dexmethylphenidate; or if you||
0439|126|P|have any other allergies. This product may contain inactive||
0439|127|P|ingredients, which can cause allergic reactions or other||
0439|128|P|problems. Talk to your pharmacist for more details.||
0439|129|P|   Before using this medication, tell your doctor or pharmacist||
0439|130|P|your medical history, especially of: high blood pressure, blood||
0439|131|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
0439|132|P|problems (such as irregular heartbeat, heart failure, previous||
0439|133|P|heart attack, problems with heart structure), family history of||
0439|134|P|heart problems (such as sudden cardiac death, irregular||
0439|135|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
0439|136|P|agitation), personal/family history of mental/mood disorders||
0439|137|P|(such as bipolar disorder, depression, psychosis, suicidal||
0439|138|P|thoughts), personal/family history of uncontrolled muscle||
0439|139|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
0439|140|P|(hyperthyroidism), seizure disorder.||
0439|141|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0439|142|P|can make you more dizzy. Do not drive, use machinery, or do||
0439|143|P|anything that needs alertness until you can do it safely. Limit||
0439|144|P|alcoholic beverages. Talk to your doctor if you are using||
0439|145|P|marijuana (cannabis).||
0439|146|P|   Before having surgery, tell your doctor or dentist about all||
0439|147|P|the products you use (including prescription drugs,||
0439|148|P|nonprescription drugs, and herbal products).||
0439|149|P|   If used for a long time, this drug may affect a child's growth||
0439|150|P|rate, weight, and final adult height. To reduce the risk, the||
0439|151|P|doctor may recommend briefly stopping the medication from time to||
0439|152|P|time. Check the child's weight and height regularly, and consult||
0439|153|P|your doctor or pharmacist for more details.||
0439|154|P|   Older adults may be more sensitive to the side effects of this||
0439|155|P|drug, especially trouble sleeping, weight loss, or chest pain.||
0439|156|P|   During pregnancy, methylphenidate should be used only when||
0439|157|P|clearly needed. Discuss the risks and benefits with your doctor.||
0439|158|P|   This medication passes into breast milk. Consult your doctor||
0439|159|P|before breastfeeding.||
0439|160|B|||
0439|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0439|162|I|medications work or increase your risk for serious side effects.||
0439|163|I|This document does not contain all possible drug interactions.||
0439|164|I|Keep a list of all the products you use (including||
0439|165|I|prescription/nonprescription drugs and herbal products) and share||
0439|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
0439|167|I|the dosage of any medicines without your doctor's approval.||
0439|168|I|   Taking MAO inhibitors with this medication may cause a serious||
0439|169|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0439|170|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0439|171|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0439|172|I|selegiline, tranylcypromine) during treatment with this||
0439|173|I|medication. Most MAO inhibitors should also not be taken for two||
0439|174|I|weeks before treatment with this medication. Ask your doctor when||
0439|175|I|to start or stop taking this medication.||
0439|176|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
0439|177|I|use medications containing dexmethylphenidate while using||
0439|178|I|methylphenidate.||
0439|179|I|   This medication may interfere with certain medical/lab tests||
0439|180|I|(such as brain scan for Parkinson's disease), possibly causing||
0439|181|I|false test results. Make sure lab personnel and all your doctors||
0439|182|I|know you use this drug.||
0439|183|B|||
0439|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0439|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0439|186|O|poison control center right away. US residents can call||
0439|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0439|188|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
0439|189|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
0439|190|O|loss of consciousness.||
0439|191|B|||
0439|192|N|NOTES:  Do not share this medication with others. Sharing it is||
0439|193|N|against the law.||
0439|194|N|   Lab and/or medical tests (such as blood pressure, complete||
0439|195|N|blood count, height/weight monitoring in children) may be done||
0439|196|N|while you are taking this medication. Keep all medical and lab||
0439|197|N|appointments. Consult your doctor for more details.||
0439|198|N|   There are different brands and forms of this medication||
0439|199|N|available. Not all have the same effects. Do not change brands or||
0439|200|N|forms without consulting your doctor or pharmacist.||
0439|201|B|||
0439|202|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0439|203|D|remember. If it is near bedtime or near the time of the next||
0439|204|D|dose, skip the missed dose. Take your next dose at the regular||
0439|205|D|time. Do not double the dose to catch up.||
0439|206|B|||
0439|207|R|STORAGE:  Store at room temperature. Keep all medications away||
0439|208|R|from children and pets.||
0439|209|R|   Do not flush medications down the toilet or pour them into a||
0439|210|R|drain unless instructed to do so. Properly discard this product||
0439|211|R|when it is expired or no longer needed. Consult your pharmacist||
0439|212|R|or local waste disposal company.||
0439|213|B|||
0439|214|A|Information last revised October 2024.||
0439|215|A|Copyright(c) 2025 First Databank, Inc.||
0439|216|B|||
0440|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0440|002|Z|does NOT have all possible information about this product. This||
0440|003|Z|information does not assure that this product is safe, effective,||
0440|004|Z|or appropriate for you. This information is not individual||
0440|005|Z|medical advice and does not substitute for the advice of your||
0440|006|Z|health care professional. Always ask your health care||
0440|007|Z|professional for complete information about this product and your||
0440|008|Z|specific health needs.||
0440|009|B|||
0440|010|T|PEGINTERFERON ALFA-2A - INJECTION||
0440|011|F|(peg-IN-ter-FEER-on AL-fa too-ay)||
0440|012|B|||
0440|013|C|COMMON BRAND NAME(S): Pegasys||
0440|014|B|||
0440|015|W|WARNING:  This medication may rarely cause or worsen some serious||
0440|016|W|medical conditions, including mental/mood problems (such as||
0440|017|W|depression), autoimmune conditions (such as lupus, rheumatoid||
0440|018|W|arthritis), blood vessel problems (such as heart disease), or||
0440|019|W|infections. Careful monitoring by your doctor may decrease your||
0440|020|W|risk. Tell your doctor right away if you develop any serious||
0440|021|W|symptoms or side effects (see Side Effects section). Some side||
0440|022|W|effects may go away or lessen after stopping treatment with this||
0440|023|W|medication.||
0440|024|B|||
0440|025|U|USES:  Peginterferon alfa-2a is used alone or in combination with||
0440|026|U|other medications to treat chronic hepatitis B and chronic||
0440|027|U|hepatitis C, viral infections of the liver. It works by||
0440|028|U|decreasing the amount of hepatitis virus in the body and helps||
0440|029|U|your body's natural defense (immune system) fight the infection.||
0440|030|U|Chronic hepatitis infection can lead to serious liver damage||
0440|031|U|(cirrhosis) and liver cancer.||
0440|032|U|   It is not known if peginterferon can cure hepatitis B or||
0440|033|U|hepatitis C infections or can prevent you from passing the virus||
0440|034|U|to others. Practice "safer sex" (such as the use of latex||
0440|035|U|condoms) to lower the risk of passing the virus to others.||
0440|036|B|||
0440|037|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
0440|038|H|provided by your pharmacist before you start using peginterferon||
0440|039|H|alfa-2a and each time you get a refill. Ask your health care||
0440|040|H|professional how to prepare and use this medication. If you have||
0440|041|H|any questions, ask your doctor or pharmacist.||
0440|042|H|   Inject this medication under the skin as directed by your||
0440|043|H|doctor, usually once every week. The injection is given in the||
0440|044|H|abdomen or thigh. Do not inject near the belly button or at the||
0440|045|H|waistline. The dosage is based on your medical condition, lab||
0440|046|H|tests, and response to treatment. Children's dosage is also based||
0440|047|H|on body size.||
0440|048|H|   For a more comfortable injection, take the medication out of||
0440|049|H|the refrigerator and let it warm to room temperature as directed||
0440|050|H|in the Instructions for Use. Do not warm up this medication any||
0440|051|H|other way (for example, do not heat it in the microwave or place||
0440|052|H|it in hot water). Do not shake this medication. Before using,||
0440|053|H|check this product for particles or discoloration. If either is||
0440|054|H|present, do not use the liquid. Before injecting each dose, clean||
0440|055|H|the skin you are going to inject into (the injection site) with||
0440|056|H|rubbing alcohol. Change the injection site each time to lessen||
0440|057|H|injury under the skin. To lessen bruising, do not rub the||
0440|058|H|injection site after a shot. Learn how to store and discard||
0440|059|H|medical supplies safely.||
0440|060|H|   Use this medication regularly to get the most benefit from it.||
0440|061|H|To help you remember, use it at about the same time on the same||
0440|062|H|day each week.||
0440|063|H|   Drink plenty of fluids while using this medication unless your||
0440|064|H|doctor directs you otherwise.||
0440|065|B|||
0440|066|S|SIDE EFFECTS:  See also Warning section.||
0440|067|S|   Most people have flu-like symptoms such as headache,||
0440|068|S|tiredness, fever, chills, and muscle aches, but these usually||
0440|069|S|decrease after the first few weeks of treatment. You can lessen||
0440|070|S|these side effects by injecting this medicine at bedtime and||
0440|071|S|using fever reducers/pain relievers such as acetaminophen before||
0440|072|S|each dose. Ask your doctor or pharmacist for more information.||
0440|073|S|Nausea, vomiting, diarrhea, dry mouth, loss of appetite,||
0440|074|S|dizziness, trouble sleeping, or redness/swelling at the injection||
0440|075|S|site may also occur. If any of these effects last or get worse,||
0440|076|S|tell your doctor or pharmacist promptly.||
0440|077|S|   Tooth and gum problems may sometimes occur during treatment.||
0440|078|S|Having a dry mouth can worsen this side effect. Prevent dry mouth||
0440|079|S|by drinking plenty of water or using a saliva substitute. Brush||
0440|080|S|your teeth well at least twice a day and have regular dental||
0440|081|S|exams. If you vomit, rinse your mouth afterward to lessen the||
0440|082|S|chance of tooth and gum problems.||
0440|083|S|   Temporary hair loss may occur. Normal hair growth should||
0440|084|S|return after treatment has ended.||
0440|085|S|   Remember that this medication has been prescribed because your||
0440|086|S|doctor has judged that the benefit to you is greater than the||
0440|087|S|risk of side effects. Many people using this medication do not||
0440|088|S|have serious side effects.||
0440|089|S|   Tell your doctor right away if you have any serious side||
0440|090|S|effects, including: easy bleeding/bruising, feeling too hot or||
0440|091|S|cold (more than others around you), gradual change in weight||
0440|092|S|(without a change in diet or exercise), unusually||
0440|093|S|slow/fast/pounding heartbeat, increased thirst/urination,||
0440|094|S|black/tarry stools, signs of liver problems (such as||
0440|095|S|nausea/vomiting that doesn't stop, loss of appetite,||
0440|096|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
0440|097|S|numbness/tingling of arms/legs.||
0440|098|S|   Get medical help right away if you have any very serious side||
0440|099|S|effects, including: chest pain, seizures, symptoms of a stroke||
0440|100|S|(such as weakness on one side of the body, trouble speaking,||
0440|101|S|confusion), vision changes (such as blurred vision, partial loss||
0440|102|S|of vision).||
0440|103|S|   This drug may cause serious mental/mood changes that may get||
0440|104|S|worse during treatment or after your last dose. Tell your doctor||
0440|105|S|right away if you have symptoms such as confusion, depression,||
0440|106|S|thoughts of suicide or hurting others, unusual irritability, or||
0440|107|S|aggressive behavior.||
0440|108|S|   This medication may lower your ability to fight infections.||
0440|109|S|This may make you more likely to get a serious (rarely fatal)||
0440|110|S|infection or make any infection you have worse. Tell your doctor||
0440|111|S|right away if you have any signs of infection (such as sore||
0440|112|S|throat that doesn't go away, fever, chills).||
0440|113|S|   A very serious allergic reaction to this drug is rare.||
0440|114|S|However, get medical help right away if you notice any symptoms||
0440|115|S|of a serious allergic reaction, including: rash, itching/swelling||
0440|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0440|117|S|breathing.||
0440|118|S|   This is not a complete list of possible side effects. If you||
0440|119|S|notice other effects not listed above, contact your doctor or||
0440|120|S|pharmacist.||
0440|121|S|   In the US -||
0440|122|S|   Call your doctor for medical advice about side effects. You||
0440|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0440|124|S|www.fda.gov/medwatch.||
0440|125|S|   In Canada - Call your doctor for medical advice about side||
0440|126|S|effects. You may report side effects to Health Canada at||
0440|127|S|1-866-234-2345.||
0440|128|B|||
0440|129|P|PRECAUTIONS:  See also Warning section.||
0440|130|P|   Before using peginterferon alfa-2a, tell your doctor or||
0440|131|P|pharmacist if you are allergic to it; or to polyethylene glycol||
0440|132|P|(PEG); or if you have any other allergies. This product may||
0440|133|P|contain inactive ingredients, which can cause allergic reactions||
0440|134|P|or other problems. Talk to your pharmacist for more details.||
0440|135|P|   Before using this medication, tell your doctor or pharmacist||
0440|136|P|your medical history, especially of: other liver problems (such||
0440|137|P|as autoimmune hepatitis), mental/mood disorders (such as||
0440|138|P|depression, psychosis, suicidal thoughts), autoimmune disorders||
0440|139|P|(such as rheumatoid arthritis, lupus, psoriasis), bleeding/blood||
0440|140|P|problems, diabetes, heart problems, high blood pressure,||
0440|141|P|intestinal problems (such as colitis), kidney disease, lung||
0440|142|P|problems (such as chronic obstructive pulmonary disease-COPD),||
0440|143|P|pancreatitis, high triglyceride levels, thyroid problems, drug or||
0440|144|P|alcohol use/abuse.||
0440|145|P|   This medication can make you more likely to get infections or||
0440|146|P|may make current infections worse. Stay away from anyone who has||
0440|147|P|an infection that may easily spread (such as chickenpox,||
0440|148|P|COVID-19, measles, flu). Talk to your doctor if you have been||
0440|149|P|exposed to an infection or for more details.||
0440|150|P|   Tell your health care professional that you are using||
0440|151|P|peginterferon alfa-2a before having any||
0440|152|P|immunizations/vaccinations. Avoid contact with people who have||
0440|153|P|recently received live vaccines (such as flu vaccine inhaled||
0440|154|P|through the nose).||
0440|155|P|   To lower the chance of getting cut, bruised, or injured, use||
0440|156|P|caution with sharp objects like razors and nail cutters, and||
0440|157|P|avoid activities such as contact sports.||
0440|158|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0440|159|P|can make you more dizzy. Do not drive, use machinery, or do||
0440|160|P|anything that needs alertness until you can do it safely. Avoid||
0440|161|P|alcoholic beverages. Talk to your doctor if you are using||
0440|162|P|marijuana (cannabis).||
0440|163|P|   Before having surgery, tell your doctor or dentist about all||
0440|164|P|the products you use (including prescription drugs,||
0440|165|P|nonprescription drugs, and herbal products).||
0440|166|P|   Children may be more sensitive to the side effects of this||
0440|167|P|drug, especially mental/mood changes (such as severe depression,||
0440|168|P|thoughts/attempts of suicide). Peginterferon alfa-2a may also||
0440|169|P|slow down a child's growth and the final adult height may be||
0440|170|P|lower than expected. See the doctor regularly so your child's||
0440|171|P|height and weight can be checked.||
0440|172|P|   Tell your doctor if you are pregnant or plan to become||
0440|173|P|pregnant. You should not become pregnant while using||
0440|174|P|peginterferon alfa-2a. Peginterferon alfa-2a may harm an unborn||
0440|175|P|baby. Ask about reliable forms of birth control while using this||
0440|176|P|medication. If you become pregnant, talk to your doctor right||
0440|177|P|away about the risks and benefits of this medication.||
0440|178|P|   It is unknown if this drug passes into breast milk. Consult||
0440|179|P|your doctor before breastfeeding.||
0440|180|B|||
0440|181|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0440|182|I|medications work or increase your risk for serious side effects.||
0440|183|I|This document does not contain all possible drug interactions.||
0440|184|I|Keep a list of all the products you use (including||
0440|185|I|prescription/nonprescription drugs and herbal products) and share||
0440|186|I|it with your doctor and pharmacist. Do not start, stop, or change||
0440|187|I|the dosage of any medicines without your doctor's approval.||
0440|188|B|||
0440|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0440|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0440|191|O|poison control center right away. US residents can call||
0440|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0440|193|B|||
0440|194|N|NOTES:  Do not share this medication with others.||
0440|195|N|   Lab and/or medical tests (such as blood counts, thyroid tests,||
0440|196|N|virus levels, kidney/liver function, triglyceride levels, eye||
0440|197|N|exams) should be done before you start using this medication and||
0440|198|N|while you are using it. Keep all medical and lab appointments.||
0440|199|N|   Do not change brands of interferon without asking your doctor||
0440|200|N|or pharmacist. Other interferons may not have the same effects on||
0440|201|N|your disease.||
0440|202|B|||
0440|203|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
0440|204|D|if it is within 2 days after your scheduled dose. Use your next||
0440|205|D|dose on the day you usually use it. If more than 2 days have||
0440|206|D|passed since your missed dose, ask your doctor or pharmacist||
0440|207|D|right away for a new dosing schedule.||
0440|208|B|||
0440|209|R|STORAGE:  Store in the refrigerator away from light and moisture.||
0440|210|R|Do not freeze. Do not leave out of the refrigerator for more than||
0440|211|R|24 hours. Keep all medications away from children and pets.||
0440|212|R|   Do not flush medications down the toilet or pour them into a||
0440|213|R|drain unless instructed to do so. Properly discard this product||
0440|214|R|when it is expired or no longer needed. Consult your pharmacist||
0440|215|R|or local waste disposal company.||
0440|216|B|||
0440|217|A|Information last revised April 2025.||
0440|218|A|Copyright(c) 2025 First Databank, Inc.||
0440|219|B|||
0441|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0441|002|Z|does NOT have all possible information about this product. This||
0441|003|Z|information does not assure that this product is safe, effective,||
0441|004|Z|or appropriate for you. This information is not individual||
0441|005|Z|medical advice and does not substitute for the advice of your||
0441|006|Z|health care professional. Always ask your health care||
0441|007|Z|professional for complete information about this product and your||
0441|008|Z|specific health needs.||
0441|009|B|||
0441|010|T|OXYCODONE CONCENTRATE SOLUTION - ORAL||
0441|011|F|(OX-i-KOE-done)||
0441|012|B|||
0441|013|C|COMMON BRAND NAME(S): Roxicodone Intensol||
0441|014|B|||
0441|015|W|WARNING:  Oxycodone has a risk for abuse and addiction, which can||
0441|016|W|lead to overdose and death. Oxycodone may also cause severe,||
0441|017|W|possibly fatal, breathing problems. To lower your risk, your||
0441|018|W|doctor should have you take the smallest dose of oxycodone that||
0441|019|W|works, and take it for the shortest possible time. See also How||
0441|020|W|to Use section for more information about addiction.||
0441|021|W|   Ask your doctor or pharmacist if you should have medication||
0441|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0441|023|W|Teach your family or household members about the signs of an||
0441|024|W|opioid overdose and how to treat it.||
0441|025|W|   The risk for severe breathing problems is higher when you||
0441|026|W|start this medication and after a dose increase, or if you take||
0441|027|W|the wrong dose/strength. Taking this medication with alcohol or||
0441|028|W|other drugs that can cause drowsiness or breathing problems may||
0441|029|W|cause very serious side effects, including death. Also, other||
0441|030|W|medications can affect the removal of oxycodone from your body,||
0441|031|W|which may affect how oxycodone works. Be sure you know how to||
0441|032|W|take oxycodone and what other drugs you should avoid taking with||
0441|033|W|it. See also Drug Interactions section. Get medical help right||
0441|034|W|away if any of these very serious side effects occur:||
0441|035|W|slow/shallow breathing, unusual lightheadedness, severe||
0441|036|W|drowsiness/dizziness, difficulty waking up.||
0441|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0441|038|W|or abuse. If someone accidentally swallows this drug, get medical||
0441|039|W|help right away.||
0441|040|W|   Before using this medication, women of childbearing age should||
0441|041|W|talk with their doctor(s) about the risks and benefits. Tell your||
0441|042|W|doctor if you are pregnant or if you plan to become pregnant.||
0441|043|W|During pregnancy, this medication should be used only when||
0441|044|W|clearly needed. It may slightly increase the risk of birth||
0441|045|W|defects if used during the first two months of pregnancy. Also,||
0441|046|W|using it for a long time or in high doses near the expected||
0441|047|W|delivery date may harm the unborn baby. To lessen the risk, take||
0441|048|W|the smallest effective dose for the shortest possible time.||
0441|049|W|Babies born to mothers who use this drug for a long time may||
0441|050|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0441|051|W|doctor right away if you notice any symptoms in your newborn baby||
0441|052|W|such as crying that doesn't stop, slow/shallow breathing,||
0441|053|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0441|054|W|difficulty gaining weight.||
0441|055|B|||
0441|056|U|USES:  This medication is used to help relieve moderate to severe||
0441|057|U|pain. Oxycodone belongs to a class of drugs known as opioid||
0441|058|U|analgesics. It works in the brain to change how your body feels||
0441|059|U|and responds to pain.||
0441|060|B|||
0441|061|H|HOW TO USE:  Read the Medication Guide provided by your||
0441|062|H|pharmacist before you start taking oxycodone and each time you||
0441|063|H|get a refill. If you have any questions, ask your doctor or||
0441|064|H|pharmacist.||
0441|065|H|   Take this medication by mouth as directed by your doctor. You||
0441|066|H|may take this drug with or without food. If you have nausea, it||
0441|067|H|may help to take this drug with food. Ask your doctor or||
0441|068|H|pharmacist about other ways to decrease nausea (such as lying||
0441|069|H|down for 1 to 2 hours with as little head movement as possible).||
0441|070|H|   If your product comes with a medicine dropper, use the||
0441|071|H|provided medicine dropper to carefully measure the dose. Do not||
0441|072|H|use a household spoon because you may not get the correct dose.||
0441|073|H|Do not confuse the dose in milligrams (mg) with the dose in||
0441|074|H|milliliters (mL). You may mix the dose with a small amount of||
0441|075|H|juice, water, applesauce or pudding. Take all of the mixed dose||
0441|076|H|right away. Ask your pharmacist or doctor if you are not sure how||
0441|077|H|to check, measure, or mix the dose.||
0441|078|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0441|079|H|using this medication unless your doctor or pharmacist says you||
0441|080|H|may do so safely. Grapefruit can increase the chance of side||
0441|081|H|effects with this medicine. Ask your doctor or pharmacist for||
0441|082|H|more details.||
0441|083|H|   The dosage is based on your medical condition and response to||
0441|084|H|treatment. Do not increase your dose, take the medication more||
0441|085|H|often, or take it for a longer time than prescribed. Properly||
0441|086|H|stop the medication when so directed.||
0441|087|H|   Pain medications work best if they are used when the first||
0441|088|H|signs of pain occur. If you wait until the pain has worsened, the||
0441|089|H|medication may not work as well.||
0441|090|H|   If you have ongoing pain (such as due to cancer), your doctor||
0441|091|H|may direct you to also take long-acting opioid medications. In||
0441|092|H|that case, this medication might be used for sudden||
0441|093|H|(breakthrough) pain only as needed. Other pain relievers (such as||
0441|094|H|acetaminophen, ibuprofen) may also be prescribed with this||
0441|095|H|medication. Ask your doctor or pharmacist about using oxycodone||
0441|096|H|safely with other drugs.||
0441|097|H|   Suddenly stopping this medication may cause withdrawal,||
0441|098|H|especially if you have used it for a long time or in high doses.||
0441|099|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0441|100|H|Tell your doctor or pharmacist right away if you have any||
0441|101|H|withdrawal symptoms such as restlessness, mental/mood changes||
0441|102|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0441|103|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0441|104|H|aches, or sudden changes in behavior.||
0441|105|H|   When this medication is used for a long time, it may not work||
0441|106|H|as well. Talk with your doctor if this medication stops working||
0441|107|H|well.||
0441|108|H|   Though it helps many people, this medication may sometimes||
0441|109|H|cause addiction. This risk may be higher if you have a||
0441|110|H|mental/mood disorder or a substance use disorder (such as overuse||
0441|111|H|of or addiction to drugs/alcohol). Take this medication exactly||
0441|112|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0441|113|H|pharmacist for more details.||
0441|114|H|   Tell your doctor if your pain does not get better or if it||
0441|115|H|gets worse, or if you have any new pain.||
0441|116|B|||
0441|117|S|SIDE EFFECTS:  See also Warning section.||
0441|118|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
0441|119|S|drowsiness may occur. Some of these side effects may decrease||
0441|120|S|after you have been using this medication for a while. If any of||
0441|121|S|these effects last or get worse, tell your doctor or pharmacist||
0441|122|S|promptly.||
0441|123|S|   To prevent constipation, eat dietary fiber, drink enough||
0441|124|S|water, and exercise. You may also need to take a laxative. Ask||
0441|125|S|your pharmacist which type of laxative is right for you.||
0441|126|S|   To reduce the risk of dizziness and lightheadedness, get up||
0441|127|S|slowly when rising from a sitting or lying position.||
0441|128|S|   Remember that this medication has been prescribed because your||
0441|129|S|doctor has judged that the benefit to you is greater than the||
0441|130|S|risk of side effects. Many people using this medication do not||
0441|131|S|have serious side effects.||
0441|132|S|   Tell your doctor right away if you have any serious side||
0441|133|S|effects, including: interrupted breathing during sleep (sleep||
0441|134|S|apnea), mental/mood changes (such as agitation, confusion,||
0441|135|S|hallucinations), severe stomach/abdominal pain, difficulty||
0441|136|S|urinating, signs of your adrenal glands not working well (such as||
0441|137|S|loss of appetite, unusual tiredness, weight loss), trouble||
0441|138|S|swallowing.||
0441|139|S|   Get medical help right away if you have any very serious side||
0441|140|S|effects, including: fainting, seizure, slow/shallow breathing,||
0441|141|S|severe drowsiness/difficulty waking up.||
0441|142|S|   A very serious allergic reaction to this drug is rare.||
0441|143|S|However, get medical help right away if you notice any symptoms||
0441|144|S|of a serious allergic reaction, including: rash, itching/swelling||
0441|145|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0441|146|S|breathing.||
0441|147|S|   This is not a complete list of possible side effects. If you||
0441|148|S|notice other effects not listed above, contact your doctor or||
0441|149|S|pharmacist.||
0441|150|S|   In the US -||
0441|151|S|   Call your doctor for medical advice about side effects. You||
0441|152|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0441|153|S|www.fda.gov/medwatch.||
0441|154|S|   In Canada - Call your doctor for medical advice about side||
0441|155|S|effects. You may report side effects to Health Canada at||
0441|156|S|1-866-234-2345.||
0441|157|B|||
0441|158|P|PRECAUTIONS:  Before taking oxycodone, tell your doctor or||
0441|159|P|pharmacist if you are allergic to it; or to other opioid pain||
0441|160|P|relievers (such as oxymorphone); or if you have any other||
0441|161|P|allergies. This product may contain inactive ingredients, which||
0441|162|P|can cause allergic reactions or other problems. Talk to your||
0441|163|P|pharmacist for more details.||
0441|164|P|   Before using this medication, tell your doctor or pharmacist||
0441|165|P|your medical history, especially of: brain disorders (such as||
0441|166|P|head injury, tumor, seizures), breathing problems (such as||
0441|167|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0441|168|P|kidney disease, liver disease, mental/mood disorders (such as||
0441|169|P|confusion, depression), personal or family history of a substance||
0441|170|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
0441|171|P|stomach/intestinal problems (such as blockage, constipation,||
0441|172|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
0441|173|P|(such as due to enlarged prostate), gallbladder disease, disease||
0441|174|P|of the pancreas (pancreatitis).||
0441|175|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0441|176|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0441|177|P|machinery, or do anything that needs alertness until you can do||
0441|178|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0441|179|P|are using marijuana (cannabis).||
0441|180|P|   Before having surgery, tell your doctor or dentist about all||
0441|181|P|the products you use (including prescription drugs,||
0441|182|P|nonprescription drugs, and herbal products).||
0441|183|P|   This product may contain sugar, aspartame, and/or alcohol.||
0441|184|P|Caution is advised if you have diabetes, alcohol dependence,||
0441|185|P|liver disease, phenylketonuria (PKU), or any other condition that||
0441|186|P|requires you to limit/avoid these substances in your diet. Ask||
0441|187|P|your doctor or pharmacist about using this product safely.||
0441|188|P|   Older adults may be more sensitive to the side effects of this||
0441|189|P|drug, especially confusion, dizziness, drowsiness, and||
0441|190|P|slow/shallow breathing.||
0441|191|P|   During pregnancy, this medication should be used only when||
0441|192|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0441|193|P|benefits with your doctor. (See also Warning section.)||
0441|194|P|   This drug passes into breast milk and may have undesirable||
0441|195|P|effects on a nursing infant. Tell the doctor right away if your||
0441|196|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0441|197|P|breathing. Consult your doctor before breastfeeding.||
0441|198|B|||
0441|199|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
0441|200|I|   Drug interactions may change how your medications work or||
0441|201|I|increase your risk for serious side effects. This document does||
0441|202|I|not contain all possible drug interactions. Keep a list of all||
0441|203|I|the products you use (including prescription/nonprescription||
0441|204|I|drugs and herbal products) and share it with your doctor and||
0441|205|I|pharmacist. Do not start, stop, or change the dosage of any||
0441|206|I|medicines without your doctor's approval.||
0441|207|I|   Some products that may interact with this drug include:||
0441|208|I|certain pain medications (mixed opioid agonists/antagonists such||
0441|209|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0441|210|I|samidorphan.||
0441|211|I|   The risk of serious side effects (such as slow/shallow||
0441|212|I|breathing, severe drowsiness/dizziness) may be increased if this||
0441|213|I|medication is taken with other products that may also cause||
0441|214|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0441|215|I|if you are taking other products such as other opioid pain or||
0441|216|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0441|217|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0441|218|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0441|219|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0441|220|I|cetirizine, diphenhydramine).||
0441|221|I|   Check the labels on all your medicines (such as allergy or||
0441|222|I|cough-and-cold products) because they may contain ingredients||
0441|223|I|that cause drowsiness. Ask your pharmacist about using those||
0441|224|I|products safely.||
0441|225|I|   Other medications can affect the removal of oxycodone from||
0441|226|I|your body, which may affect how oxycodone works. Examples include||
0441|227|I|azole antifungals (such as ketoconazole), macrolide antibiotics||
0441|228|I|(such as erythromycin), mifepristone, HIV medications (such as||
0441|229|I|tipranavir), rifamycins (such as rifabutin, rifampin), ritonavir,||
0441|230|I|certain drugs used to treat seizures (such as carbamazepine,||
0441|231|I|phenytoin), among others.||
0441|232|I|   This medication may interfere with certain lab tests (such as||
0441|233|I|amylase/lipase levels), possibly causing false test results. Make||
0441|234|I|sure lab personnel and all your doctors know you use this drug.||
0441|235|B|||
0441|236|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0441|237|O|as passing out or trouble breathing, give them naloxone or||
0441|238|O|nalmefene if available, then call 911. If the person is awake and||
0441|239|O|has no symptoms, call a poison control center right away. US||
0441|240|O|residents can call 1-800-222-1222. Canada residents can call||
0441|241|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0441|242|O|breathing, slow heartbeat, coma.||
0441|243|B|||
0441|244|N|NOTES:  Do not share this medication with others. Sharing it is||
0441|245|N|against the law.||
0441|246|N|   This medication has been prescribed for your current condition||
0441|247|N|only. Do not use it later for another condition unless told to do||
0441|248|N|so by your doctor. A different medication may be necessary in||
0441|249|N|that case.||
0441|250|B|||
0441|251|D|MISSED DOSE:  If you are taking this medication on a regular||
0441|252|D|schedule and miss a dose, take it as soon as you remember. If it||
0441|253|D|is near the time of the next dose, skip the missed dose. Take||
0441|254|D|your next dose at the regular time. Do not double the dose to||
0441|255|D|catch up.||
0441|256|B|||
0441|257|R|STORAGE:  Store at room temperature away from light and moisture.||
0441|258|R|Do not store in the bathroom. Keep all medications away from||
0441|259|R|children and pets.||
0441|260|R|   Do not flush medications down the toilet or pour them into a||
0441|261|R|drain unless instructed to do so. Properly discard this product||
0441|262|R|when it is expired or no longer needed. For more details, read||
0441|263|R|the Medication Guide, or consult your pharmacist or local waste||
0441|264|R|disposal company.||
0441|265|B|||
0441|266|A|Information last revised August 2025.||
0441|267|A|Copyright(c) 2025 First Databank, Inc.||
0441|268|B|||
0442|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0442|002|Z|does NOT have all possible information about this product. This||
0442|003|Z|information does not assure that this product is safe, effective,||
0442|004|Z|or appropriate for you. This information is not individual||
0442|005|Z|medical advice and does not substitute for the advice of your||
0442|006|Z|health care professional. Always ask your health care||
0442|007|Z|professional for complete information about this product and your||
0442|008|Z|specific health needs.||
0442|009|B|||
0442|010|T|MULTIVITAMINS/IRON/FLUORIDE LIQUID - ORAL||
0442|011|B|||
0442|012|W|WARNING:  Accidental overdose of iron-containing products is a||
0442|013|W|leading cause of fatal poisoning in children younger than 6||
0442|014|W|years. Keep this product out of the reach of children. If||
0442|015|W|overdose does occur, get medical help right away or call a poison||
0442|016|W|control center.||
0442|017|B|||
0442|018|U|USES:  This medication is a combination product of vitamins,||
0442|019|U|iron, and fluoride. It is used in infants and children to treat||
0442|020|U|or prevent deficiency due to poor diet or low levels of fluoride||
0442|021|U|in drinking water and other sources. Vitamins are important||
0442|022|U|building blocks of the body and help keep you in good health.||
0442|023|U|Iron is an important mineral that the body needs to make red||
0442|024|U|blood cells. Fluoride is used to prevent dental cavities.||
0442|025|B|||
0442|026|H|HOW TO USE:  Take this medication by mouth as directed by the||
0442|027|H|doctor, usually once daily.||
0442|028|H|   If your liquid is a suspension, shake the bottle well before||
0442|029|H|each dose. Some brands of this medication should also be shaken||
0442|030|H|well before each dose. Check your manufacturer's bottle for||
0442|031|H|specific directions. Use a medication-measuring device to||
0442|032|H|carefully measure the prescribed dose. Do not use a household||
0442|033|H|spoon. The dose may be swallowed directly, added to a small||
0442|034|H|amount of liquid, or mixed with a small amount of food, such as||
0442|035|H|applesauce.||
0442|036|H|   The fluoride in this liquid product can be absorbed directly||
0442|037|H|into the teeth as you swallow it, as well as being absorbed into||
0442|038|H|your body from your stomach. It is best not to eat, drink, or||
0442|039|H|rinse your mouth for 30 minutes after taking this product.||
0442|040|H|   This product is best taken at least 2 hours before or after||
0442|041|H|taking any products containing calcium (including dairy foods||
0442|042|H|such as milk/yogurt) or aluminum/magnesium (such as certain||
0442|043|H|antacids/laxatives), since these may decrease its effectiveness.||
0442|044|H|   This product should be taken regularly in order to get the||
0442|045|H|most benefit form it. Do not take more than prescribed. To help||
0442|046|H|you remember, take it at the same time each day.||
0442|047|B|||
0442|048|S|SIDE EFFECTS:  Stomach upset, constipation, or nausea may occur.||
0442|049|S|If any of these effects last or get worse, contact your doctor or||
0442|050|S|pharmacist promptly.||
0442|051|S|   The iron in this product may cause the stools to turn black,||
0442|052|S|which is not harmful.||
0442|053|S|   If your teeth become mottled or stained, tell the dentist or||
0442|054|S|doctor. This may be a result of too much fluoride.||
0442|055|S|   Remember that this medication has been prescribed because your||
0442|056|S|doctor has judged that the benefit to you is greater than the||
0442|057|S|risk of side effects. Many people using this medication do not||
0442|058|S|have serious side effects.||
0442|059|S|   A very serious allergic reaction to this drug is rare.||
0442|060|S|However, get medical help right away if you notice any symptoms||
0442|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0442|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0442|063|S|breathing.||
0442|064|S|   This is not a complete list of possible side effects. If you||
0442|065|S|notice other effects not listed above, contact your doctor or||
0442|066|S|pharmacist.||
0442|067|S|   In the US -||
0442|068|S|   Call your doctor for medical advice about side effects. You||
0442|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0442|070|S|www.fda.gov/medwatch.||
0442|071|S|   In Canada - Call your doctor for medical advice about side||
0442|072|S|effects. You may report side effects to Health Canada at||
0442|073|S|1-866-234-2345.||
0442|074|B|||
0442|075|P|PRECAUTIONS:  Before taking multivitamins and iron with fluoride,||
0442|076|P|tell your doctor if you are allergic to any of the ingredients;||
0442|077|P|or if you have any other allergies. This product may contain||
0442|078|P|inactive ingredients, which can cause allergic reactions or other||
0442|079|P|problems. Talk to your pharmacist for more details.||
0442|080|P|   Before taking this medication, tell your doctor or pharmacist||
0442|081|P|your medical history.||
0442|082|P|   Before having surgery, tell your doctor or dentist about all||
0442|083|P|the products you use (including prescription drugs,||
0442|084|P|nonprescription drugs, and herbal products).||
0442|085|P|   Tell your doctor if you are pregnant before using this||
0442|086|P|medication.||
0442|087|P|   This product passes into breast milk. Consult your doctor||
0442|088|P|before breastfeeding.||
0442|089|B|||
0442|090|I|DRUG INTERACTIONS:  See also How To Use section.||
0442|091|I|   Drug interactions may change how your medications work or||
0442|092|I|increase your risk for serious side effects. This document does||
0442|093|I|not contain all possible drug interactions. Keep a list of all||
0442|094|I|the products you use (including prescription/nonprescription||
0442|095|I|drugs and herbal products) and share it with your doctor and||
0442|096|I|pharmacist. Do not start, stop, or change the dosage of any||
0442|097|I|medicines without your doctor's approval.||
0442|098|I|   This product can decrease the absorption of certain drugs,||
0442|099|I|especially if you take them around the same time. These drugs||
0442|100|I|include bisphosphonates (such as alendronate), levodopa,||
0442|101|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
0442|102|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
0442|103|I|minocycline), thyroid medications (such as levothyroxine), among||
0442|104|I|others. Ask your doctor or pharmacist how long you should wait||
0442|105|I|between doses of this product and your other medications and to||
0442|106|I|find a dosing schedule that works for all your medications.||
0442|107|I|   This product may interfere with certain lab tests, possibly||
0442|108|I|causing false test results. Make sure lab personnel and all your||
0442|109|I|doctors know you use this product.||
0442|110|B|||
0442|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0442|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0442|113|O|poison control center right away. US residents can call||
0442|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0442|115|O|Symptoms of overdose may include vomiting, stomach/abdominal||
0442|116|O|pain, green diarrhea, tarry stools, increased saliva, drowsiness,||
0442|117|O|seizures.||
0442|118|B|||
0442|119|N|NOTES:  This product is not a substitute for a proper diet.||
0442|120|N|Remember that it is best to get your vitamins from healthy foods.||
0442|121|N|It is important to maintain a well-balanced diet.||
0442|122|N|   Check the fluoride content of your water supply by asking||
0442|123|N|local town or city officials. Fluoride supplements are not||
0442|124|N|necessary if the fluoride content in the water supply is greater||
0442|125|N|than 0.6 parts per million. If your water supply changes, check||
0442|126|N|with your doctor or dentist to determine if extra fluoride is||
0442|127|N|still necessary.||
0442|128|B|||
0442|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0442|130|D|remember. If it is near the time of the next dose, skip the||
0442|131|D|missed dose. Take your next dose at the regular time. Do not||
0442|132|D|double the dose to catch up.||
0442|133|B|||
0442|134|R|STORAGE:  Different brands of this medication have different||
0442|135|R|storage needs. Check the product package for instructions on how||
0442|136|R|to store your brand, or ask your pharmacist. Keep all medications||
0442|137|R|away from children and pets.||
0442|138|R|   Do not flush medications down the toilet or pour them into a||
0442|139|R|drain unless instructed to do so. Properly discard this product||
0442|140|R|when it is expired or no longer needed. Consult your pharmacist||
0442|141|R|or local waste disposal company.||
0442|142|B|||
0442|143|A|Information last revised October 2025.||
0442|144|A|Copyright(c) 2025 First Databank, Inc.||
0442|145|B|||
0443|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0443|002|Z|does NOT have all possible information about this product. This||
0443|003|Z|information does not assure that this product is safe, effective,||
0443|004|Z|or appropriate for you. This information is not individual||
0443|005|Z|medical advice and does not substitute for the advice of your||
0443|006|Z|health care professional. Always ask your health care||
0443|007|Z|professional for complete information about this product and your||
0443|008|Z|specific health needs.||
0443|009|B|||
0443|010|T|MULTIVITAMINS/IRON/FLUORIDE CHEWABLE TABLET - ORAL||
0443|011|B|||
0443|012|W|WARNING:  Accidental overdose of iron-containing products is a||
0443|013|W|leading cause of fatal poisoning in children under 6 years of||
0443|014|W|age. Keep this product out of reach of children. If overdose||
0443|015|W|occurs, get medical help right away or call a poison control||
0443|016|W|center.||
0443|017|B|||
0443|018|U|USES:  This product is a combination of vitamins, iron, and||
0443|019|U|fluoride. It is used by children to treat or prevent deficiency||
0443|020|U|due to poor diet or low levels of fluoride in drinking water and||
0443|021|U|other sources. Vitamins and iron are important building blocks of||
0443|022|U|the body and help keep you in good health. Fluoride is used to||
0443|023|U|prevent dental cavities.||
0443|024|B|||
0443|025|H|HOW TO USE:  Chew this medication thoroughly and swallow as||
0443|026|H|directed by the doctor, usually once daily after brushing the||
0443|027|H|teeth. If your child cannot safely chew and swallow this tablet,||
0443|028|H|consult your doctor or pharmacist for advice.||
0443|029|H|   This medication is best taken on an empty stomach 1 hour||
0443|030|H|before or 2 hours after meals. If stomach upset occurs, you may||
0443|031|H|take this medication with food. Avoid taking antacids, dairy||
0443|032|H|products, tea, or coffee within 2 hours before or after this||
0443|033|H|medication because they will decrease its effectiveness.||
0443|034|H|   The fluoride in this chewable tablet can be absorbed directly||
0443|035|H|into the teeth during and after chewing, as well as being||
0443|036|H|absorbed into your body from your stomach. It is best not to eat,||
0443|037|H|drink, or rinse your mouth for 30 minutes after taking this||
0443|038|H|product.||
0443|039|H|   Take this medication regularly to get the most benefit from||
0443|040|H|it. To help you remember, take it at the same time each day. Do||
0443|041|H|not take more than the prescribed dose.||
0443|042|B|||
0443|043|S|SIDE EFFECTS:  Stomach upset, constipation, or nausea may occur.||
0443|044|S|If any of these effects last or get worse, tell your doctor or||
0443|045|S|pharmacist promptly.||
0443|046|S|   Iron may cause your stools to turn black, an effect that is||
0443|047|S|not harmful.||
0443|048|S|   If your teeth become mottled or stained, tell your dentist or||
0443|049|S|doctor. This may be a result of too much fluoride.||
0443|050|S|   Remember that this medication has been prescribed because your||
0443|051|S|doctor has judged that the benefit to you is greater than the||
0443|052|S|risk of side effects. Many people using this medication do not||
0443|053|S|have serious side effects.||
0443|054|S|   A very serious allergic reaction to this drug is rare.||
0443|055|S|However, get medical help right away if you notice any symptoms||
0443|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0443|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0443|058|S|breathing.||
0443|059|S|   This is not a complete list of possible side effects. If you||
0443|060|S|notice other effects not listed above, contact your doctor or||
0443|061|S|pharmacist.||
0443|062|S|   In the US -||
0443|063|S|   Call your doctor for medical advice about side effects. You||
0443|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0443|065|S|www.fda.gov/medwatch.||
0443|066|S|   In Canada - Call your doctor for medical advice about side||
0443|067|S|effects. You may report side effects to Health Canada at||
0443|068|S|1-866-234-2345.||
0443|069|B|||
0443|070|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0443|071|P|pharmacist if you are allergic to any of its ingredients; or if||
0443|072|P|you have any other allergies. This product may contain inactive||
0443|073|P|ingredients, which can cause allergic reactions or other||
0443|074|P|problems. Talk to your pharmacist for more details.||
0443|075|P|   Before taking this medication, tell your doctor or pharmacist||
0443|076|P|your medical history.||
0443|077|P|   This medication may contain aspartame. If you have||
0443|078|P|phenylketonuria (PKU), or any other condition that requires you||
0443|079|P|to limit/avoid aspartame (or phenylalanine) in your diet, ask||
0443|080|P|your doctor or pharmacist about using this product safely.||
0443|081|P|   Before having surgery, tell your doctor or dentist about all||
0443|082|P|the products you use (including prescription drugs,||
0443|083|P|nonprescription drugs, and herbal products).||
0443|084|P|   This product is not usually used by adults. It is unlikely to||
0443|085|P|be used during pregnancy or breastfeeding. Consult your doctor if||
0443|086|P|you have any questions about this product.||
0443|087|B|||
0443|088|I|DRUG INTERACTIONS:  See also How To Use section.||
0443|089|I|   Drug interactions may change how your medications work or||
0443|090|I|increase your risk for serious side effects. This document does||
0443|091|I|not contain all possible drug interactions. Keep a list of all||
0443|092|I|the products you use (including prescription/nonprescription||
0443|093|I|drugs and herbal products) and share it with your doctor and||
0443|094|I|pharmacist. Do not start, stop, or change the dosage of any||
0443|095|I|medicines without your doctor's approval.||
0443|096|I|   This product can decrease the absorption of certain drugs,||
0443|097|I|especially if you take them around the same time. These drugs||
0443|098|I|include bisphosphonates (such as alendronate), levodopa,||
0443|099|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
0443|100|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
0443|101|I|minocycline), thyroid medications (such as levothyroxine), among||
0443|102|I|others. Ask your doctor or pharmacist how long you should wait||
0443|103|I|between doses of this product and your other medications and to||
0443|104|I|find a dosing schedule that works for all your medications.||
0443|105|B|||
0443|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0443|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0443|108|O|poison control center right away. US residents can call||
0443|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0443|110|B|||
0443|111|N|NOTES:  Do not share this product with others.||
0443|112|N|   Remember that it is best to get your vitamins and minerals||
0443|113|N|from food whenever possible. Maintain a well-balanced diet, and||
0443|114|N|follow any dietary guidelines as directed by your doctor.||
0443|115|N|   Check the fluoride content of your water supply by asking||
0443|116|N|local town or city officials. Fluoride supplements are not||
0443|117|N|necessary if the fluoride content in the water supply is greater||
0443|118|N|than 0.6 parts per million. If your water supply changes, check||
0443|119|N|with your doctor or dentist to determine if extra fluoride is||
0443|120|N|still needed.||
0443|121|B|||
0443|122|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0443|123|D|remember. If it is near the time of the next dose, skip the||
0443|124|D|missed dose. Take your next dose at the regular time. Do not||
0443|125|D|double the dose to catch up.||
0443|126|B|||
0443|127|R|STORAGE:  Store at room temperature away from light and moisture.||
0443|128|R|Do not store in the bathroom. Keep all medications away from||
0443|129|R|children and pets.||
0443|130|R|   Do not flush medications down the toilet or pour them into a||
0443|131|R|drain unless instructed to do so. Properly discard this product||
0443|132|R|when it is expired or no longer needed. Consult your pharmacist||
0443|133|R|or local waste disposal company.||
0443|134|B|||
0443|135|A|Information last revised October 2025.||
0443|136|A|Copyright(c) 2025 First Databank, Inc.||
0443|137|B|||
0445|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0445|002|Z|does NOT have all possible information about this product. This||
0445|003|Z|information does not assure that this product is safe, effective,||
0445|004|Z|or appropriate for you. This information is not individual||
0445|005|Z|medical advice and does not substitute for the advice of your||
0445|006|Z|health care professional. Always ask your health care||
0445|007|Z|professional for complete information about this product and your||
0445|008|Z|specific health needs.||
0445|009|B|||
0445|010|T|PIROXICAM - ORAL||
0445|011|F|(pir-OX-i-kam)||
0445|012|B|||
0445|013|C|COMMON BRAND NAME(S): Feldene||
0445|014|B|||
0445|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0445|016|W|piroxicam) may rarely increase the risk for a heart attack or||
0445|017|W|stroke. This effect can happen at any time while taking this drug||
0445|018|W|but is more likely if you take it for a long time. The risk may||
0445|019|W|be greater in older adults or if you have heart disease or||
0445|020|W|increased risk for heart disease (for example, due to smoking,||
0445|021|W|family history of heart disease, or conditions such as high blood||
0445|022|W|pressure or diabetes). Do not take this drug right before or||
0445|023|W|after heart bypass surgery (CABG).||
0445|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
0445|025|W|from the stomach or intestines. This effect can occur without||
0445|026|W|warning at any time while taking this drug. Older adults may be||
0445|027|W|at higher risk for this effect.||
0445|028|W|   Stop taking piroxicam and get medical help right away if you||
0445|029|W|notice any of these rare but serious side effects:||
0445|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0445|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0445|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0445|033|W|side of the body, trouble speaking, sudden vision changes.||
0445|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0445|035|W|of taking this drug.||
0445|036|B|||
0445|037|U|USES:  Piroxicam is used to reduce pain, swelling, and joint||
0445|038|U|stiffness from arthritis. Reducing these symptoms helps you do||
0445|039|U|more of your normal daily activities. This medication is known as||
0445|040|U|a nonsteroidal anti-inflammatory drug (NSAID). It works by||
0445|041|U|blocking your body's production of certain natural substances||
0445|042|U|that cause inflammation.||
0445|043|U|   If you are treating a chronic condition such as arthritis, ask||
0445|044|U|your doctor about non-drug treatments and/or using other||
0445|045|U|medications to treat your pain. See also Warning section.||
0445|046|B|||
0445|047|V|OTHER USES:  This section contains uses of this drug that are not||
0445|048|V|listed in the approved professional labeling for the drug but||
0445|049|V|that may be prescribed by your health care professional. Use this||
0445|050|V|drug for a condition that is listed in this section only if it||
0445|051|V|has been so prescribed by your health care professional.||
0445|052|V|   This drug may also be used for gout attacks.||
0445|053|B|||
0445|054|H|HOW TO USE:  Read the Medication Guide provided by your||
0445|055|H|pharmacist before you start using piroxicam and each time you get||
0445|056|H|a refill. If you have any questions, ask your doctor or||
0445|057|H|pharmacist.||
0445|058|H|   Take this medication by mouth as directed by your doctor,||
0445|059|H|usually once daily with a full glass of water (8 ounces/240||
0445|060|H|milliliters). Do not lie down for at least 10 minutes after||
0445|061|H|taking this drug. To prevent stomach upset, take this medication||
0445|062|H|with food, milk, or an antacid.||
0445|063|H|   The dosage is based on your medical condition and response to||
0445|064|H|treatment. To reduce your risk of stomach bleeding and other side||
0445|065|H|effects, take this medication at the lowest effective dose for||
0445|066|H|the shortest possible time. Do not increase your dose, take it||
0445|067|H|more often, or take it for a longer time than prescribed.||
0445|068|H|   If you are taking this drug "as needed" (not on a regular||
0445|069|H|schedule), remember that pain medications work best if they are||
0445|070|H|used as the first signs of pain occur. If you wait until the pain||
0445|071|H|has worsened, the medication may not work as well.||
0445|072|H|   It may take several weeks of taking this drug regularly until||
0445|073|H|you get the full benefit.||
0445|074|H|   Tell your doctor if your condition does not get better or if||
0445|075|H|it gets worse.||
0445|076|B|||
0445|077|S|SIDE EFFECTS:  See also Warning section.||
0445|078|S|   Upset stomach, nausea, dizziness, drowsiness, or headache may||
0445|079|S|occur. If any of these effects last or get worse, tell your||
0445|080|S|doctor or pharmacist promptly.||
0445|081|S|   Remember that this medication has been prescribed because your||
0445|082|S|doctor has judged that the benefit to you is greater than the||
0445|083|S|risk of side effects. Many people using this medication do not||
0445|084|S|have serious side effects.||
0445|085|S|   This medication may raise your blood pressure. Check your||
0445|086|S|blood pressure regularly and tell your doctor if the results are||
0445|087|S|high.||
0445|088|S|   Tell your doctor right away if you have any serious side||
0445|089|S|effects, including: easy bruising/bleeding, difficult/painful||
0445|090|S|swallowing, hearing changes (such as ringing in the ears),||
0445|091|S|mental/mood changes, signs of kidney problems (such as change in||
0445|092|S|the amount of urine), vision changes, symptoms of heart failure||
0445|093|S|(such as swelling ankles/feet, unusual tiredness, unusual/sudden||
0445|094|S|weight gain).||
0445|095|S|   This drug may rarely cause serious (possibly fatal) liver||
0445|096|S|disease. Get medical help right away if you have any symptoms of||
0445|097|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0445|098|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
0445|099|S|eyes/skin.||
0445|100|S|   A very serious allergic reaction to this drug is rare.||
0445|101|S|However, get medical help right away if you notice any symptoms||
0445|102|S|of a serious allergic reaction, including: fever, swollen lymph||
0445|103|S|nodes, rash, itching/swelling (especially of the||
0445|104|S|face/tongue/throat), severe dizziness, trouble breathing.||
0445|105|S|   This is not a complete list of possible side effects. If you||
0445|106|S|notice other effects not listed above, contact your doctor or||
0445|107|S|pharmacist.||
0445|108|S|   In the US -||
0445|109|S|   Call your doctor for medical advice about side effects. You||
0445|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0445|111|S|www.fda.gov/medwatch.||
0445|112|S|   In Canada - Call your doctor for medical advice about side||
0445|113|S|effects. You may report side effects to Health Canada at||
0445|114|S|1-866-234-2345.||
0445|115|B|||
0445|116|P|PRECAUTIONS:  Before taking piroxicam, tell your doctor or||
0445|117|P|pharmacist if you are allergic to it; or to aspirin or other||
0445|118|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
0445|119|P|any other allergies. This product may contain inactive||
0445|120|P|ingredients, which can cause allergic reactions or other||
0445|121|P|problems. Talk to your pharmacist for more details.||
0445|122|P|   Before taking this medication, tell your doctor or pharmacist||
0445|123|P|your medical history, especially of: asthma (including a history||
0445|124|P|of worsening breathing after taking aspirin or other NSAIDs),||
0445|125|P|blood disorders (such as anemia, bleeding/clotting problems),||
0445|126|P|growths in the nose (nasal polyps), heart disease (such as||
0445|127|P|previous heart attack), high blood pressure, liver disease,||
0445|128|P|stroke, throat/stomach/intestinal problems (such as bleeding,||
0445|129|P|heartburn, ulcers).||
0445|130|P|   Kidney problems can sometimes occur with the use of NSAID||
0445|131|P|medications, including piroxicam. Problems are more likely to||
0445|132|P|occur if you are dehydrated, have heart failure or kidney||
0445|133|P|disease, are an older adult, or if you take certain medications||
0445|134|P|(see also Drug Interactions section). Drink plenty of fluids as||
0445|135|P|directed by your doctor to prevent dehydration and tell your||
0445|136|P|doctor right away if you have a change in the amount of urine.||
0445|137|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0445|138|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0445|139|P|machinery, or do anything that needs alertness until you can do||
0445|140|P|it safely. Talk to your doctor if you are using marijuana||
0445|141|P|(cannabis).||
0445|142|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0445|143|P|and tobacco, especially when combined with this medicine, may||
0445|144|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0445|145|P|smoking. Consult your doctor or pharmacist for more information.||
0445|146|P|   This medication may make you more sensitive to the sun. Limit||
0445|147|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0445|148|P|sunscreen and wear protective clothing when outdoors. Tell your||
0445|149|P|doctor right away if you get sunburned or have skin||
0445|150|P|blisters/redness.||
0445|151|P|   Before having surgery, tell your doctor or dentist about all||
0445|152|P|the products you use (including prescription drugs,||
0445|153|P|nonprescription drugs, and herbal products).||
0445|154|P|   Older adults may be at greater risk for stomach/intestinal||
0445|155|P|bleeding, kidney problems, heart attack, and stroke while using||
0445|156|P|this drug.||
0445|157|P|   Before using this medication, women of childbearing age should||
0445|158|P|talk with their doctor(s) about the benefits and risks. Tell your||
0445|159|P|doctor if you are pregnant or if you plan to become pregnant.||
0445|160|P|This medication may harm an unborn baby and cause problems with||
0445|161|P|normal labor/delivery. It is not recommended for use in pregnancy||
0445|162|P|from 20 weeks until delivery. If your doctor decides that you||
0445|163|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0445|164|P|you should use the lowest effective dose for the shortest||
0445|165|P|possible time. You should not use this medication after 30 weeks||
0445|166|P|of pregnancy.||
0445|167|P|   This medication passes into breast milk. Consult your doctor||
0445|168|P|before breastfeeding.||
0445|169|B|||
0445|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0445|171|I|medications work or increase your risk for serious side effects.||
0445|172|I|This document does not contain all possible drug interactions.||
0445|173|I|Keep a list of all the products you use (including||
0445|174|I|prescription/nonprescription drugs and herbal products) and share||
0445|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
0445|176|I|the dosage of any medicines without your doctor's approval.||
0445|177|I|   Products that may interact with this drug include: aliskiren,||
0445|178|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
0445|179|I|receptor blockers (such as losartan, valsartan), cidofovir,||
0445|180|I|corticosteroids (such as prednisone), lithium, "water pills"||
0445|181|I|(diuretics such as furosemide).||
0445|182|I|   This medication may increase the risk of bleeding when taken||
0445|183|I|with other drugs that also may cause bleeding. Examples include||
0445|184|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0445|185|I|dabigatran/enoxaparin/warfarin, among others.||
0445|186|I|   Check all prescription and nonprescription medicine labels||
0445|187|I|carefully since many medications contain pain relievers/fever||
0445|188|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
0445|189|I|ketorolac). These drugs are similar to piroxicam and may increase||
0445|190|I|your risk of side effects if taken together. However, if your||
0445|191|I|doctor has told you to take low-dose aspirin to prevent heart||
0445|192|I|attack or stroke (usually 81-162 milligrams a day), you should||
0445|193|I|keep taking the aspirin unless your doctor tells you not to. Ask||
0445|194|I|your doctor or pharmacist for more details.||
0445|195|B|||
0445|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0445|197|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0445|198|O|poison control center right away. US residents can call||
0445|199|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0445|200|O|Symptoms of overdose may include: severe stomach pain, trouble||
0445|201|O|breathing, extreme drowsiness.||
0445|202|B|||
0445|203|N|NOTES:  Do not share this medication with others.||
0445|204|N|   Lab and/or medical tests (such as blood pressure, complete||
0445|205|N|blood count, liver/kidney function) may be done while you are||
0445|206|N|taking this medication. Keep all medical and lab appointments.||
0445|207|N|Consult your doctor for more details.||
0445|208|N|   Lifestyle changes (such as weight loss if needed,||
0445|209|N|strengthening/conditioning exercises) may help improve your||
0445|210|N|flexibility and joint function. Consult your doctor for specific||
0445|211|N|instructions.||
0445|212|B|||
0445|213|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
0445|214|D|(not just "as needed") and you miss a dose, take it as soon as||
0445|215|D|you remember. If it is near the time of the next dose, skip the||
0445|216|D|missed dose. Take your next dose at the regular time. Do not||
0445|217|D|double the dose to catch up.||
0445|218|B|||
0445|219|R|STORAGE:  Store at room temperature away from light and moisture.||
0445|220|R|Do not store in the bathroom. Keep all medications away from||
0445|221|R|children and pets.||
0445|222|R|   Do not flush medications down the toilet or pour them into a||
0445|223|R|drain unless instructed to do so. Properly discard this product||
0445|224|R|when it is expired or no longer needed. Consult your pharmacist||
0445|225|R|or local waste disposal company.||
0445|226|B|||
0445|227|A|Information last revised October 2024.||
0445|228|A|Copyright(c) 2025 First Databank, Inc.||
0445|229|B|||
0447|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0447|002|Z|does NOT have all possible information about this product. This||
0447|003|Z|information does not assure that this product is safe, effective,||
0447|004|Z|or appropriate for you. This information is not individual||
0447|005|Z|medical advice and does not substitute for the advice of your||
0447|006|Z|health care professional. Always ask your health care||
0447|007|Z|professional for complete information about this product and your||
0447|008|Z|specific health needs.||
0447|009|B|||
0447|010|T|SULINDAC - ORAL||
0447|011|F|(SUL-in-dak)||
0447|012|B|||
0447|013|C|COMMON BRAND NAME(S): Clinoril||
0447|014|B|||
0447|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0447|016|W|sulindac) may rarely increase the risk of a heart attack or||
0447|017|W|stroke. This effect can happen at any time while taking this drug||
0447|018|W|but is more likely if you take it for a long time. The risk may||
0447|019|W|be greater in older adults or if you have heart disease or||
0447|020|W|increased risk for heart disease (for example, due to smoking,||
0447|021|W|family history of heart disease, or conditions such as high blood||
0447|022|W|pressure or diabetes). Do not take this drug right before or||
0447|023|W|after heart bypass surgery (CABG).||
0447|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0447|025|W|bleeding from the stomach or intestines. This effect can occur||
0447|026|W|without warning symptoms at any time while taking this drug.||
0447|027|W|Older adults may be at higher risk for this effect.||
0447|028|W|   Stop taking sulindac and get medical help right away if you||
0447|029|W|notice any of these rare but serious side effects:||
0447|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0447|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0447|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0447|033|W|side of the body, trouble speaking, sudden vision changes.||
0447|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0447|035|W|of taking this drug.||
0447|036|B|||
0447|037|U|USES:  See also Warning section.||
0447|038|U|   Sulindac is used to reduce pain, swelling, and joint stiffness||
0447|039|U|from arthritis. It is also used to treat arthritis of the spine,||
0447|040|U|gouty arthritis, and shoulder bursitis/tendonitis.||
0447|041|U|   Sulindac is known as a nonsteroidal anti-inflammatory drug||
0447|042|U|(NSAID). It works by blocking your body's production of certain||
0447|043|U|natural substances that cause inflammation. This effect helps to||
0447|044|U|decrease swelling, pain, or fever.||
0447|045|U|   If you are treating a chronic condition such as arthritis, ask||
0447|046|U|your doctor about non-drug treatments and/or using other||
0447|047|U|medications to treat your pain.||
0447|048|B|||
0447|049|H|HOW TO USE:  Read the Medication Guide provided by your||
0447|050|H|pharmacist before you start taking sulindac and each time you get||
0447|051|H|a refill. If you have any questions, ask your doctor or||
0447|052|H|pharmacist.||
0447|053|H|   Take this medication by mouth as directed by your doctor,||
0447|054|H|usually twice daily. Take this medication with a full glass of||
0447|055|H|water (8 ounces/240 milliliters), unless your doctor directs you||
0447|056|H|otherwise. Do not lie down for at least 10 minutes after taking||
0447|057|H|this medication. If stomach upset occurs while taking this||
0447|058|H|medication, take it with food, milk, or an antacid.||
0447|059|H|   The dosage is based on your medical condition and response to||
0447|060|H|treatment. To reduce your risk of stomach bleeding and other side||
0447|061|H|effects, take this medication at the lowest effective dose for||
0447|062|H|the shortest possible time. Do not increase your dose or take||
0447|063|H|this drug more often or for longer than prescribed. Discuss the||
0447|064|H|risks and benefits with your doctor or pharmacist.||
0447|065|H|   For certain conditions (such as arthritis), it may take 1-2||
0447|066|H|weeks of taking this drug regularly until you get the full||
0447|067|H|benefit.||
0447|068|H|   If you are taking this drug "as needed" (not on a regular||
0447|069|H|schedule), remember that pain medications work best if they are||
0447|070|H|used as the first signs of pain occur. If you wait until the pain||
0447|071|H|has worsened, the medicine may not work as well.||
0447|072|H|   Tell your doctor if your condition gets worse.||
0447|073|B|||
0447|074|S|SIDE EFFECTS:  See also Warning section.||
0447|075|S|   Upset stomach, nausea, vomiting, gas, diarrhea, constipation,||
0447|076|S|dizziness, or headache may occur. If any of these effects last or||
0447|077|S|get worse, tell your doctor or pharmacist promptly.||
0447|078|S|   Remember that this medication has been prescribed because your||
0447|079|S|doctor has judged that the benefit to you is greater than the||
0447|080|S|risk of side effects. Many people using this medication do not||
0447|081|S|have serious side effects.||
0447|082|S|   This medication may raise your blood pressure. Check your||
0447|083|S|blood pressure regularly and tell your doctor if the results are||
0447|084|S|high.||
0447|085|S|   Tell your doctor right away if you have any serious side||
0447|086|S|effects, including: hearing changes (such as ringing in the||
0447|087|S|ears), mental/mood changes, easy bleeding/bruising,||
0447|088|S|difficult/painful swallowing, unexplained stiff neck, signs of||
0447|089|S|kidney problems (such as change in the amount of urine,||
0447|090|S|pink/bloody urine), symptoms of heart failure (such as swelling||
0447|091|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
0447|092|S|   Sulindac may rarely cause serious (possibly fatal) liver||
0447|093|S|disease. Get medical help right away if you have any symptoms of||
0447|094|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
0447|095|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0447|096|S|urine.||
0447|097|S|   A very serious allergic reaction to this drug is rare.||
0447|098|S|However, get medical help right away if you notice any symptoms||
0447|099|S|of a serious allergic reaction, including: fever, swollen lymph||
0447|100|S|nodes, rash, itching/swelling (especially of the||
0447|101|S|face/tongue/throat), severe dizziness, trouble breathing.||
0447|102|S|   This is not a complete list of possible side effects. If you||
0447|103|S|notice other effects not listed above, contact your doctor or||
0447|104|S|pharmacist.||
0447|105|S|   In the US -||
0447|106|S|   Call your doctor for medical advice about side effects. You||
0447|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0447|108|S|www.fda.gov/medwatch.||
0447|109|S|   In Canada - Call your doctor for medical advice about side||
0447|110|S|effects. You may report side effects to Health Canada at||
0447|111|S|1-866-234-2345.||
0447|112|B|||
0447|113|P|PRECAUTIONS:  See also Warning section.||
0447|114|P|   Before taking sulindac, tell your doctor or pharmacist if you||
0447|115|P|are allergic to it; or to aspirin or other NSAIDs (such as||
0447|116|P|ibuprofen, naproxen, celecoxib); or if you have any other||
0447|117|P|allergies. This product may contain inactive ingredients, which||
0447|118|P|can cause allergic reactions or other problems. Talk to your||
0447|119|P|pharmacist for more details.||
0447|120|P|   Before using this medication, tell your doctor or pharmacist||
0447|121|P|your medical history, especially of: asthma (including a history||
0447|122|P|of worsening breathing after taking aspirin or other NSAIDs),||
0447|123|P|blood disorders (such as anemia, bleeding/clotting problems),||
0447|124|P|growths in the nose (nasal polyps), heart disease (such as||
0447|125|P|previous heart attack), high blood pressure, kidney stones, liver||
0447|126|P|disease, stroke, swelling (edema, fluid retention),||
0447|127|P|stomach/intestinal/esophagus problems (such as bleeding,||
0447|128|P|heartburn, ulcers).||
0447|129|P|   Kidney problems can sometimes occur with the use of NSAID||
0447|130|P|medications, including sulindac. Problems are more likely to||
0447|131|P|occur if you are dehydrated, have heart failure or kidney||
0447|132|P|disease, are an older adult, or if you take certain medications||
0447|133|P|(see also Drug Interactions section). Drink plenty of fluids as||
0447|134|P|directed by your doctor to prevent dehydration and tell your||
0447|135|P|doctor right away if you have pink/bloody urine or any unusual||
0447|136|P|change in the amount of urine.||
0447|137|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0447|138|P|can make you more dizzy. Do not drive, use machinery, or do||
0447|139|P|anything that needs alertness until you can do it safely. Limit||
0447|140|P|alcoholic beverages. Talk to your doctor if you are using||
0447|141|P|marijuana (cannabis).||
0447|142|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0447|143|P|and tobacco, especially when combined with this medicine, may||
0447|144|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0447|145|P|smoking.||
0447|146|P|   This medication may make you more sensitive to the sun. Limit||
0447|147|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0447|148|P|sunscreen and wear protective clothing when outdoors. Tell your||
0447|149|P|doctor right away if you get sunburned or have skin||
0447|150|P|blisters/redness.||
0447|151|P|   Before having surgery, tell your doctor or dentist about all||
0447|152|P|the products you use (including prescription drugs,||
0447|153|P|nonprescription drugs, and herbal products).||
0447|154|P|   Older adults may be at greater risk for stomach/intestinal||
0447|155|P|bleeding, kidney problems, heart attack, and stroke while using||
0447|156|P|this drug.||
0447|157|P|   Before using this medication, women of childbearing age should||
0447|158|P|talk with their doctor(s) about the benefits and risks. Tell your||
0447|159|P|doctor if you are pregnant or if you plan to become pregnant.||
0447|160|P|This medication may harm an unborn baby and cause problems with||
0447|161|P|normal labor/delivery. It is not recommended for use in pregnancy||
0447|162|P|from 20 weeks until delivery. If your doctor decides that you||
0447|163|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0447|164|P|you should use the lowest effective dose for the shortest||
0447|165|P|possible time. You should not use this medication after 30 weeks||
0447|166|P|of pregnancy.||
0447|167|P|   It is unknown if this medication passes into breast milk.||
0447|168|P|Breastfeeding is not recommended while using this medication.||
0447|169|P|Consult your doctor before breastfeeding.||
0447|170|B|||
0447|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0447|172|I|medications work or increase your risk for serious side effects.||
0447|173|I|This document does not contain all possible drug interactions.||
0447|174|I|Keep a list of all the products you use (including||
0447|175|I|prescription/nonprescription drugs and herbal products) and share||
0447|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
0447|177|I|the dosage of any medicines without your doctor's approval.||
0447|178|I|   Some products that may interact with this drug are: aliskiren,||
0447|179|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
0447|180|I|receptor blockers (such as losartan, valsartan), cidofovir,||
0447|181|I|corticosteroids (such as dexamethasone, prednisone), dimethyl||
0447|182|I|sulfoxide (DMSO), lithium, methotrexate, "water pills" (diuretics||
0447|183|I|such as furosemide).||
0447|184|I|   This medication may increase the risk of bleeding when taken||
0447|185|I|with other drugs that also may cause bleeding. Examples include||
0447|186|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0447|187|I|dabigatran/enoxaparin/warfarin, among others.||
0447|188|I|   Check all prescription and nonprescription medicine labels||
0447|189|I|carefully since many medications contain pain relievers/fever||
0447|190|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
0447|191|I|naproxen). These drugs are similar to sulindac and may increase||
0447|192|I|your risk of side effects if taken together. However, if your||
0447|193|I|doctor has told you to take low-dose aspirin to prevent heart||
0447|194|I|attack or stroke (usually 81-162 milligrams a day), you should||
0447|195|I|keep taking the aspirin unless your doctor tells you not to. Ask||
0447|196|I|your doctor or pharmacist for more details.||
0447|197|B|||
0447|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0447|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0447|200|O|poison control center right away. US residents can call||
0447|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0447|202|O|Symptoms of overdose may include: severe stomach pain,||
0447|203|O|slow/shallow breathing, extreme drowsiness, loss of||
0447|204|O|consciousness.||
0447|205|B|||
0447|206|N|NOTES:  Do not share this medication with others.||
0447|207|N|   Lab and/or medical tests (such as complete blood count,||
0447|208|N|liver/kidney function, blood pressure) may be done while you are||
0447|209|N|using this medication. Keep all medical and lab appointments.||
0447|210|N|Consult your doctor for more details.||
0447|211|N|   Lifestyle changes (such as weight loss if needed,||
0447|212|N|strengthening/conditioning exercises) may help improve your||
0447|213|N|flexibility and joint function. Consult your doctor for specific||
0447|214|N|instructions.||
0447|215|B|||
0447|216|D|MISSED DOSE:  If you are prescribed this drug on a regular||
0447|217|D|schedule (not just "as needed") and you miss a dose, take it as||
0447|218|D|soon as you remember. If it is near the time of the next dose,||
0447|219|D|skip the missed dose. Take your next dose at the regular time. Do||
0447|220|D|not double the dose to catch up.||
0447|221|B|||
0447|222|R|STORAGE:  Store at room temperature away from light and moisture.||
0447|223|R|Do not store in the bathroom. Keep all medications away from||
0447|224|R|children and pets.||
0447|225|R|   Do not flush medications down the toilet or pour them into a||
0447|226|R|drain unless instructed to do so. Properly discard this product||
0447|227|R|when it is expired or no longer needed. Consult your pharmacist||
0447|228|R|or local waste disposal company.||
0447|229|B|||
0447|230|A|Information last revised May 2024.||
0447|231|A|Copyright(c) 2025 First Databank, Inc.||
0447|232|B|||
0448|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0448|002|Z|does NOT have all possible information about this product. This||
0448|003|Z|information does not assure that this product is safe, effective,||
0448|004|Z|or appropriate for you. This information is not individual||
0448|005|Z|medical advice and does not substitute for the advice of your||
0448|006|Z|health care professional. Always ask your health care||
0448|007|Z|professional for complete information about this product and your||
0448|008|Z|specific health needs.||
0448|009|B|||
0448|010|T|DESOXIMETASONE - TOPICAL||
0448|011|F|(des-OX-i-MET-a-sone)||
0448|012|B|||
0448|013|C|COMMON BRAND NAME(S): Topicort, Topicort LP||
0448|014|B|||
0448|015|U|USES:  This medication is used to treat a variety of skin||
0448|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0448|017|U|Desoximetasone reduces the swelling, itching and redness that can||
0448|018|U|occur in these types of conditions. This medication is a strong||
0448|019|U|corticosteroid.||
0448|020|B|||
0448|021|H|HOW TO USE:  Use this medication only on the skin. Do not use it||
0448|022|H|on the face, groin, or underarms unless directed to do so by your||
0448|023|H|doctor.||
0448|024|H|   Wash and dry your hands. Before applying the medication, clean||
0448|025|H|and dry the affected area. Apply a thin film of the medication to||
0448|026|H|the affected area and gently rub in as directed by your doctor,||
0448|027|H|usually twice daily. Do not cover, bandage or wrap the area||
0448|028|H|unless directed to do so by your doctor.||
0448|029|H|   After applying the medication, wash your hands unless you are||
0448|030|H|using this medication to treat the hands. When applying this||
0448|031|H|medication near the eyes, avoid getting it in the eyes as this||
0448|032|H|may worsen or cause glaucoma. Also, avoid getting this medication||
0448|033|H|in the nose or mouth. If you get the medication in your eyes,||
0448|034|H|nose, or mouth, rinse with plenty of water.||
0448|035|H|   Use this medication only for the condition prescribed. Do not||
0448|036|H|use it for longer than prescribed.||
0448|037|H|   Tell your doctor if your condition lasts or gets worse.||
0448|038|B|||
0448|039|S|SIDE EFFECTS:  Burning, itching, irritation, or dryness may occur||
0448|040|S|when this medication is first applied to the skin. This should||
0448|041|S|disappear in a few days as your body adjusts to the medication.||
0448|042|S|If any of these effects last or get worse, notify your doctor or||
0448|043|S|pharmacist promptly.||
0448|044|S|   Remember that this medication has been prescribed because your||
0448|045|S|doctor has judged that the benefit to you is greater than the||
0448|046|S|risk of side effects. Many people using this medication do not||
0448|047|S|have serious side effects.||
0448|048|S|   Tell your doctor right away if you have any serious side||
0448|049|S|effects, including: stretch marks, skin thinning/discoloration,||
0448|050|S|acne, excessive hair growth, small red bumps on the skin||
0448|051|S|(folliculitis).||
0448|052|S|   Skin infections can become worse when this medication is used.||
0448|053|S|Notify your doctor if redness, swelling or irritation does not||
0448|054|S|improve.||
0448|055|S|   Rarely, it is possible this medication will be absorbed from||
0448|056|S|the skin into the bloodstream. This can lead to side effects of||
0448|057|S|too much corticosteroid. These side effects are more likely in||
0448|058|S|children, and in people who use this medication for a long time||
0448|059|S|or over large areas of the skin. Tell your doctor right away if||
0448|060|S|any of the following side effects occur: unusual/extreme||
0448|061|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0448|062|S|thirst/urination, vision problems.||
0448|063|S|   A very serious allergic reaction to this drug is rare.||
0448|064|S|However, get medical help right away if you notice any symptoms||
0448|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0448|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0448|067|S|breathing.||
0448|068|S|   This is not a complete list of possible side effects. If you||
0448|069|S|notice other effects not listed above, contact your doctor or||
0448|070|S|pharmacist.||
0448|071|S|   In the US -||
0448|072|S|   Call your doctor for medical advice about side effects. You||
0448|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0448|074|S|www.fda.gov/medwatch.||
0448|075|S|   In Canada - Call your doctor for medical advice about side||
0448|076|S|effects. You may report side effects to Health Canada at||
0448|077|S|1-866-234-2345.||
0448|078|B|||
0448|079|P|PRECAUTIONS:  Before using desoximetasone, tell your doctor or||
0448|080|P|pharmacist if you are allergic to it; or to other corticosteroids||
0448|081|P|(such as hydrocortisone, prednisone); or if you have any other||
0448|082|P|allergies. This product may contain inactive ingredients, which||
0448|083|P|can cause allergic reactions or other problems. Talk to your||
0448|084|P|pharmacist for more details.||
0448|085|P|   Before using this medication, tell your doctor or pharmacist||
0448|086|P|your medical history, especially of: poor blood circulation,||
0448|087|P|immune system problems.||
0448|088|P|   Do not use if there is an infection or sore present in the||
0448|089|P|area to be treated.||
0448|090|P|   Rarely, using corticosteroid medications for a long time or||
0448|091|P|over large areas of skin can make it more difficult for your body||
0448|092|P|to respond to physical stress. Before having surgery or emergency||
0448|093|P|treatment, or if you get a serious illness/injury, tell your||
0448|094|P|doctor or dentist that you are using this medication or have used||
0448|095|P|this medication within the past few months.||
0448|096|P|   Though it is unlikely, this medication may temporarily slow||
0448|097|P|down a child's growth if used for a long time. See the doctor||
0448|098|P|regularly so your child's height can be checked.||
0448|099|P|   During pregnancy, this medication should be used only when||
0448|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0448|101|P|   It is unknown if this drug passes into breast milk when||
0448|102|P|applied to the skin. Similar medications pass into breast milk||
0448|103|P|when taken by mouth. Consult your doctor before breastfeeding.||
0448|104|B|||
0448|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0448|106|I|medications work or increase your risk for serious side effects.||
0448|107|I|This document does not contain all possible drug interactions.||
0448|108|I|Keep a list of all the products you use (including||
0448|109|I|prescription/nonprescription drugs and herbal products) and share||
0448|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0448|111|I|the dosage of any medicines without your doctor's approval.||
0448|112|B|||
0448|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0448|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0448|115|O|poison control center right away. US residents can call||
0448|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0448|117|O|medication may be harmful if swallowed.||
0448|118|B|||
0448|119|N|NOTES:  Do not share this medication with others.||
0448|120|N|   This medication has been prescribed for your current condition||
0448|121|N|only. Do not use it later for other skin problems unless told to||
0448|122|N|do so by your doctor. A different medication may be necessary in||
0448|123|N|those cases.||
0448|124|N|   Lab and/or medical tests (such as adrenal gland function) may||
0448|125|N|be done while you are using this medication, especially if you||
0448|126|N|use this drug for an extended period of time or apply it over||
0448|127|N|large areas of the body. Keep all medical and lab appointments.||
0448|128|N|Consult your doctor for more details.||
0448|129|B|||
0448|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0448|131|D|If it is near the time of the next dose, skip the missed dose.||
0448|132|D|Use your next dose at the regular time. Do not double the dose to||
0448|133|D|catch up.||
0448|134|B|||
0448|135|R|STORAGE:  Store at room temperature away. Keep all medications||
0448|136|R|away from children and pets.||
0448|137|R|   Do not flush medications down the toilet or pour them into a||
0448|138|R|drain unless instructed to do so. Properly discard this product||
0448|139|R|when it is expired or no longer needed. Consult your pharmacist||
0448|140|R|or local waste disposal company.||
0448|141|B|||
0448|142|A|Information last revised October 2024.||
0448|143|A|Copyright(c) 2025 First Databank, Inc.||
0448|144|B|||
0449|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0449|002|Z|does NOT have all possible information about this product. This||
0449|003|Z|information does not assure that this product is safe, effective,||
0449|004|Z|or appropriate for you. This information is not individual||
0449|005|Z|medical advice and does not substitute for the advice of your||
0449|006|Z|health care professional. Always ask your health care||
0449|007|Z|professional for complete information about this product and your||
0449|008|Z|specific health needs.||
0449|009|B|||
0449|010|T|DIMENHYDRINATE SUPPOSITORY - RECTAL||
0449|011|F|(DYE-men-HYE-dri-nate)||
0449|012|B|||
0449|013|U|USES:  Dimenhydrinate is an antihistamine used to prevent and||
0449|014|U|treat nausea, vomiting, and dizziness caused by motion sickness||
0449|015|U|when medication cannot be given by mouth.||
0449|016|U|   Do not use this medication for children younger than two years||
0449|017|U|unless directed by the doctor.||
0449|018|B|||
0449|019|V|OTHER USES:  This section contains uses of this drug that are not||
0449|020|V|listed in the approved professional labeling for the drug but||
0449|021|V|that may be prescribed by your health care professional. Use this||
0449|022|V|drug for a condition that is listed in this section only if it||
0449|023|V|has been so prescribed by your health care professional.||
0449|024|V|   This drug may also be used for other motion and balance||
0449|025|V|problems, such as feelings of dizziness/spinning (vertigo) and||
0449|026|V|inner ear problems (such as Meniere's disease). It may also be||
0449|027|V|used for nausea and vomiting due to surgery, radiation sickness,||
0449|028|V|side effects of drug treatment, and other causes.||
0449|029|B|||
0449|030|H|HOW TO USE:  For motion sickness, unwrap and insert one||
0449|031|H|suppository rectally 30 minutes to 1 hour before starting||
0449|032|H|activity such as travel, or use as directed by your doctor.||
0449|033|H|   Do not use more medication than recommended. The dosage is||
0449|034|H|based on your age, medical condition and response to treatment.||
0449|035|H|Ask your doctor or pharmacist if you have any questions.||
0449|036|H|   Tell your doctor if your condition does not get better or if||
0449|037|H|it gets worse.||
0449|038|B|||
0449|039|S|SIDE EFFECTS:  Drowsiness, constipation, blurred vision, or dry||
0449|040|S|mouth/nose/throat may occur. If any of these effects last or get||
0449|041|S|worse, tell your doctor or pharmacist promptly.||
0449|042|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0449|043|S|chips, chew (sugarless) gum, drink water or use a saliva||
0449|044|S|substitute.||
0449|045|S|   Remember that this medication has been prescribed because your||
0449|046|S|doctor has judged that the benefit to you is greater than the||
0449|047|S|risk of side effects. Many people using this medication do not||
0449|048|S|have serious side effects.||
0449|049|S|   Tell your doctor right away if you have any serious side||
0449|050|S|effects, including: mental/mood changes (such as restlessness,||
0449|051|S|confusion), fast/irregular heartbeat, shaking (tremor),||
0449|052|S|difficulty urinating.||
0449|053|S|   Get medical help right away if you have any very serious side||
0449|054|S|effects, including: seizures.||
0449|055|S|   A very serious allergic reaction to this drug is rare.||
0449|056|S|However, get medical help right away if you notice any symptoms||
0449|057|S|of a serious allergic reaction, including: rash, itching/swelling||
0449|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0449|059|S|breathing.||
0449|060|S|   This is not a complete list of possible side effects. If you||
0449|061|S|notice other effects not listed above, contact your doctor or||
0449|062|S|pharmacist.||
0449|063|S|   In the US -||
0449|064|S|   Call your doctor for medical advice about side effects. You||
0449|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0449|066|S|www.fda.gov/medwatch.||
0449|067|S|   In Canada - Call your doctor for medical advice about side||
0449|068|S|effects. You may report side effects to Health Canada at||
0449|069|S|1-866-234-2345.||
0449|070|B|||
0449|071|P|PRECAUTIONS:  Before using dimenhydrinate, tell your doctor or||
0449|072|P|pharmacist if you are allergic to it; or to diphenhydramine; or||
0449|073|P|if you have any other allergies. This product may contain||
0449|074|P|inactive ingredients, which can cause allergic reactions or other||
0449|075|P|problems. Talk to your pharmacist for more details.||
0449|076|P|   Before using this medication, tell your doctor or pharmacist||
0449|077|P|your medical history, especially of: breathing problems (such as||
0449|078|P|asthma, emphysema), glaucoma, heart problems, high blood||
0449|079|P|pressure, liver disease, seizures, stomach problems (such as||
0449|080|P|ulcers, obstruction), overactive thyroid, difficulty urinating||
0449|081|P|(such as due to an enlarged prostate gland).||
0449|082|P|   This drug may make you drowsy or blur your vision. Alcohol or||
0449|083|P|marijuana (cannabis) can make you more drowsy. Do not drive, use||
0449|084|P|machinery, or do anything that needs alertness or clear vision||
0449|085|P|until you can do it safely. Avoid alcoholic beverages. Talk to||
0449|086|P|your doctor if you are using marijuana (cannabis).||
0449|087|P|   Before having surgery, tell your doctor or dentist about all||
0449|088|P|the products you use (including prescription drugs,||
0449|089|P|nonprescription drugs, and herbal products).||
0449|090|P|   Children may be more sensitive to the side effects of this||
0449|091|P|drug. This drug can often cause excitement in young children||
0449|092|P|instead of drowsiness.||
0449|093|P|   Older adults may be more sensitive to the side effects of this||
0449|094|P|drug, especially drowsiness, confusion, constipation, or trouble||
0449|095|P|urinating. Drowsiness and confusion can increase the risk of||
0449|096|P|falling.||
0449|097|P|   During pregnancy, this medication should be used only when||
0449|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
0449|099|P|   This drug passes into breast milk and may have undesirable||
0449|100|P|effects on a nursing infant. Consult your doctor before||
0449|101|P|breastfeeding.||
0449|102|B|||
0449|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0449|104|I|medications work or increase your risk for serious side effects.||
0449|105|I|This document does not contain all possible drug interactions.||
0449|106|I|Keep a list of all the products you use (including||
0449|107|I|prescription/nonprescription drugs and herbal products) and share||
0449|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
0449|109|I|the dosage of any medicines without your doctor's approval.||
0449|110|I|   Some products that may interact with this drug include:||
0449|111|I|antihistamines applied to the skin (such as diphenhydramine||
0449|112|I|cream, ointment, spray).||
0449|113|I|   Tell your doctor or pharmacist if you are taking other||
0449|114|I|products that cause drowsiness such as opioid pain or cough||
0449|115|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0449|116|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0449|117|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0449|118|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0449|119|I|diphenhydramine).||
0449|120|I|   Check the labels on all your medicines (such as allergy or||
0449|121|I|cough-and-cold products) because they may contain ingredients||
0449|122|I|that cause drowsiness. Ask your pharmacist about using those||
0449|123|I|products safely.||
0449|124|I|   This medication may interfere with certain lab tests (such as||
0449|125|I|allergy skin test), possibly causing false test results. Make||
0449|126|I|sure lab personnel and all your doctors know you use this drug.||
0449|127|B|||
0449|128|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0449|129|O|has overdosed and has serious symptoms such as passing out or||
0449|130|O|trouble breathing, call 911. Otherwise, call a poison control||
0449|131|O|center right away. US residents can call 1-800-222-1222. Canada||
0449|132|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0449|133|O|include: severe drowsiness, seizures, widened pupils. In||
0449|134|O|children, mental/mood changes (such as restlessness,||
0449|135|O|irritability, hallucinations) may occur before drowsiness.||
0449|136|B|||
0449|137|N|NOTES:  Do not share this product with others.||
0449|138|B|||
0449|139|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0449|140|D|If it is near the time of your next dose, skip the missed dose.||
0449|141|D|Use your next dose at the regular. Do not double the dose to||
0449|142|D|catch up.||
0449|143|B|||
0449|144|R|STORAGE:  Refer to storage information on the package label. If||
0449|145|R|you have any questions about storage, ask your pharmacist. Keep||
0449|146|R|all medications away from children and pets.||
0449|147|R|   Do not flush medications down the toilet or pour them into a||
0449|148|R|drain unless instructed to do so. Properly discard this product||
0449|149|R|when it is expired or no longer needed. Consult your pharmacist||
0449|150|R|or local waste disposal company.||
0449|151|B|||
0449|152|A|Information last revised January 2025.||
0449|153|A|Copyright(c) 2025 First Databank, Inc.||
0449|154|B|||
0450|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0450|002|Z|does NOT have all possible information about this product. This||
0450|003|Z|information does not assure that this product is safe, effective,||
0450|004|Z|or appropriate for you. This information is not individual||
0450|005|Z|medical advice and does not substitute for the advice of your||
0450|006|Z|health care professional. Always ask your health care||
0450|007|Z|professional for complete information about this product and your||
0450|008|Z|specific health needs.||
0450|009|B|||
0450|010|T|ERYTHROMYCIN ETHYLSUCCINATE - ORAL||
0450|011|F|(e-RITH-roe-MYE-sin ETH-il-SUX-i-nate)||
0450|012|B|||
0450|013|C|COMMON BRAND NAME(S): EES||
0450|014|B|||
0450|015|U|USES:  Erythromycin is used to treat a wide variety of bacterial||
0450|016|U|infections. It may also be used to prevent certain bacterial||
0450|017|U|infections. Erythromycin is known as a macrolide antibiotic. It||
0450|018|U|works by stopping the growth of bacteria.||
0450|019|U|   This antibiotic treats or prevents only bacterial infections.||
0450|020|U|It will not work for viral infections (such as common cold, flu).||
0450|021|U|Using any antibiotic when it is not needed can cause it to not||
0450|022|U|work for future infections.||
0450|023|B|||
0450|024|V|OTHER USES:  This section contains uses of this drug that are not||
0450|025|V|listed in the approved professional labeling for the drug but||
0450|026|V|that may be prescribed by your health care professional. Use this||
0450|027|V|drug for a condition that is listed in this section only if it||
0450|028|V|has been so prescribed by your health care professional.||
0450|029|V|   This drug may also be used for a certain type of stomach||
0450|030|V|condition involving slowed digestion (gastroparesis).||
0450|031|B|||
0450|032|H|HOW TO USE:  Take this medication by mouth with or without food||
0450|033|H|as directed by your doctor. If nausea occurs, taking this||
0450|034|H|medication with food or milk may reduce this side effect.||
0450|035|H|   This medication has a bitter taste if crushed. Swallow the||
0450|036|H|medication whole. Do not chew or crush.||
0450|037|H|   The dosage and length of treatment are based on your medical||
0450|038|H|condition and response to treatment. Children's dosage is also||
0450|039|H|based on age and weight.||
0450|040|H|   For the best effect, take this antibiotic at evenly spaced||
0450|041|H|times. To help you remember, take this medication at the same||
0450|042|H|time(s) every day.||
0450|043|H|   If you are using this medication to treat an infection,||
0450|044|H|continue to take this medication until the full prescribed amount||
0450|045|H|is finished, even if symptoms disappear after a few days.||
0450|046|H|Stopping the medication too early may result in a return of the||
0450|047|H|infection. Tell your doctor if your condition lasts or gets||
0450|048|H|worse.||
0450|049|H|   If you are taking this medication to prevent certain bacterial||
0450|050|H|infections, take it exactly as directed by your doctor. Do not||
0450|051|H|stop taking the medication without your doctor's approval.||
0450|052|B|||
0450|053|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach pain/cramping,||
0450|054|S|and loss of appetite may occur. Taking this medication with food||
0450|055|S|may lessen these symptoms. If any of these effects last or get||
0450|056|S|worse, tell your doctor or pharmacist promptly.||
0450|057|S|   Remember that this medication has been prescribed because your||
0450|058|S|doctor has judged that the benefit to you is greater than the||
0450|059|S|risk of side effects. Many people using this medication do not||
0450|060|S|have serious side effects.||
0450|061|S|   Tell your doctor right away if you have any serious side||
0450|062|S|effects, including: signs of liver disease (such as||
0450|063|S|nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
0450|064|S|urine, severe stomach/abdominal pain), unusual tiredness, muscle||
0450|065|S|weakness, trouble speaking, blurred vision, drooping eyelids,||
0450|066|S|hearing loss.||
0450|067|S|   Get medical help right away if you have any very serious side||
0450|068|S|effects, including: severe dizziness, fainting, fast/irregular||
0450|069|S|heartbeat.||
0450|070|S|   This medication may rarely cause a severe intestinal condition||
0450|071|S|due to a bacteria called C. difficile. This condition may occur||
0450|072|S|during treatment or weeks to months after treatment has stopped.||
0450|073|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0450|074|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0450|075|S|stool.||
0450|076|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0450|077|S|products because they may make symptoms worse.||
0450|078|S|   Use of this medication for prolonged or repeated periods may||
0450|079|S|result in oral thrush or a new yeast infection. Contact your||
0450|080|S|doctor if you notice white patches in your mouth, a change in||
0450|081|S|vaginal discharge or other new symptoms.||
0450|082|S|   A very serious allergic reaction to this drug is rare.||
0450|083|S|However, get medical help right away if you notice any symptoms||
0450|084|S|of a serious allergic reaction, including: rash, itching/swelling||
0450|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0450|086|S|breathing.||
0450|087|S|   This is not a complete list of possible side effects. If you||
0450|088|S|notice other effects not listed above, contact your doctor or||
0450|089|S|pharmacist.||
0450|090|S|   In the US -||
0450|091|S|   Call your doctor for medical advice about side effects. You||
0450|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0450|093|S|www.fda.gov/medwatch.||
0450|094|S|   In Canada - Call your doctor for medical advice about side||
0450|095|S|effects. You may report side effects to Health Canada at||
0450|096|S|1-866-234-2345.||
0450|097|B|||
0450|098|P|PRECAUTIONS:  Before taking erythromycin, tell your doctor or||
0450|099|P|pharmacist if you are allergic to it; or to other macrolide||
0450|100|P|antibiotics (such as azithromycin, clarithromycin); or if you||
0450|101|P|have any other allergies. This product may contain inactive||
0450|102|P|ingredients, which can cause allergic reactions or other||
0450|103|P|problems. Talk to your pharmacist for more details.||
0450|104|P|   Before using this medication, tell your doctor or pharmacist||
0450|105|P|your medical history, especially of: kidney disease, liver||
0450|106|P|disease, a certain type of muscle disease (myasthenia gravis).||
0450|107|P|   Erythromycin may cause a condition that affects the heart||
0450|108|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0450|109|P|serious (rarely fatal) fast/irregular heartbeat and other||
0450|110|P|symptoms (such as severe dizziness, fainting) that need medical||
0450|111|P|attention right away.||
0450|112|P|   The risk of QT prolongation may be increased if you have||
0450|113|P|certain medical conditions or are taking other drugs that may||
0450|114|P|cause QT prolongation. Before using erythromycin, tell your||
0450|115|P|doctor or pharmacist of all the drugs you take and if you have||
0450|116|P|any of the following conditions: certain heart problems (heart||
0450|117|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0450|118|P|history of certain heart problems (QT prolongation in the EKG,||
0450|119|P|sudden cardiac death).||
0450|120|P|   Low levels of potassium or magnesium in the blood may also||
0450|121|P|increase your risk of QT prolongation. This risk may increase if||
0450|122|P|you use certain drugs (such as diuretics/"water pills") or if you||
0450|123|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0450|124|P|Talk to your doctor about using erythromycin safely.||
0450|125|P|   Erythromycin may cause live bacterial vaccines (such as||
0450|126|P|typhoid vaccine) to not work well. Tell your health care||
0450|127|P|professional that you are using erythromycin before having any||
0450|128|P|immunizations/vaccinations.||
0450|129|P|   Before having surgery, tell your doctor or dentist about all||
0450|130|P|the products you use (including prescription drugs,||
0450|131|P|nonprescription drugs, and herbal products).||
0450|132|P|   Some erythromycin products may contain sodium. Ask your doctor||
0450|133|P|or pharmacist for more information if you are on a||
0450|134|P|salt-restricted diet or if you have a condition that could be||
0450|135|P|worsened by an increase in salt intake (such as heart failure).||
0450|136|P|   Older adults may be more sensitive to the side effects of this||
0450|137|P|drug, especially hearing loss and QT prolongation (see above).||
0450|138|P|   Tell your doctor if you are pregnant before using this||
0450|139|P|medication.||
0450|140|P|   This medication passes into breast milk. Consult your doctor||
0450|141|P|before breastfeeding.||
0450|142|B|||
0450|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0450|144|I|medications work or increase your risk for serious side effects.||
0450|145|I|This document does not contain all possible drug interactions.||
0450|146|I|Keep a list of all the products you use (including||
0450|147|I|prescription/nonprescription drugs and herbal products) and share||
0450|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
0450|149|I|the dosage of any medicines without your doctor's approval.||
0450|150|I|   A product that may interact with this drug is: digoxin.||
0450|151|I|   Many drugs besides erythromycin may affect the heart rhythm||
0450|152|I|(QT prolongation), including amiodarone, dofetilide, pimozide,||
0450|153|I|procainamide, propafenone, quinidine, sotalol, among others.||
0450|154|I|   Other medications can affect the removal of erythromycin from||
0450|155|I|your body, which may affect how erythromycin works. Examples||
0450|156|I|include azole antifungals (such as itraconazole, ketoconazole),||
0450|157|I|certain calcium channel blockers (such as diltiazem, verapamil),||
0450|158|I|certain anti-seizure medications (such as carbamazepine,||
0450|159|I|phenytoin), among others.||
0450|160|I|   Erythromycin can slow down the removal of other drugs from||
0450|161|I|your body, which may affect how they work. Examples of affected||
0450|162|I|drugs include bromocriptine, colchicine, certain benzodiazepines||
0450|163|I|(such as midazolam, triazolam), eletriptan, ergot alkaloids (such||
0450|164|I|as ergotamine, dihydroergotamine), certain drugs to treat||
0450|165|I|erectile dysfunction-ED or pulmonary hypertension (such as||
0450|166|I|sildenafil, tadalafil), certain "statin" drugs (such as||
0450|167|I|lovastatin, simvastatin), vinblastine, among others.||
0450|168|I|   This medication may interfere with certain lab tests (such as||
0450|169|I|urine tests), possibly causing false test results. Make sure lab||
0450|170|I|personnel and all your doctors know you use this drug.||
0450|171|B|||
0450|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0450|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0450|174|O|poison control center right away. US residents can call||
0450|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0450|176|B|||
0450|177|N|NOTES:  Do not share this medication with others.||
0450|178|N|   This medication has been prescribed for your current condition||
0450|179|N|only. Do not use it later for another infection unless your||
0450|180|N|doctor tells you to.||
0450|181|B|||
0450|182|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0450|183|D|remember. If it is near the time of the next dose, skip the||
0450|184|D|missed dose. Take your next dose at the regular time. Do not||
0450|185|D|double the dose to catch up.||
0450|186|B|||
0450|187|R|STORAGE:  Store at room temperature away from light and moisture.||
0450|188|R|Do not store in the bathroom. Keep all medications away from||
0450|189|R|children and pets.||
0450|190|R|   Do not flush medications down the toilet or pour them into a||
0450|191|R|drain unless instructed to do so. Properly discard this product||
0450|192|R|when it is expired or no longer needed. Consult your pharmacist||
0450|193|R|or local waste disposal company.||
0450|194|B|||
0450|195|A|Information last revised May 2025.||
0450|196|A|Copyright(c) 2025 First Databank, Inc.||
0450|197|B|||
0451|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0451|002|Z|does NOT have all possible information about this product. This||
0451|003|Z|information does not assure that this product is safe, effective,||
0451|004|Z|or appropriate for you. This information is not individual||
0451|005|Z|medical advice and does not substitute for the advice of your||
0451|006|Z|health care professional. Always ask your health care||
0451|007|Z|professional for complete information about this product and your||
0451|008|Z|specific health needs.||
0451|009|B|||
0451|010|T|CLOBETASOL LOTION - TOPICAL||
0451|011|F|(kloe-BAY-ta-sol)||
0451|012|B|||
0451|013|C|COMMON BRAND NAME(S): Clobex||
0451|014|B|||
0451|015|U|USES:  This medication is used by adults to treat a variety of||
0451|016|U|skin conditions (such as eczema, dermatitis, psoriasis).||
0451|017|U|Clobetasol reduces the swelling, itching and redness that can||
0451|018|U|occur in these types of conditions. This medication is a very||
0451|019|U|strong (super-high-potency) corticosteroid.||
0451|020|U|   This medication is not recommended for use in children younger||
0451|021|U|than 18 years of age due to an increased risk of side effects.||
0451|022|U|Ask the doctor or pharmacist for details.||
0451|023|B|||
0451|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0451|025|H|from your pharmacist before you start using clobetasol lotion and||
0451|026|H|each time you get a refill. If you have any questions, ask your||
0451|027|H|doctor or pharmacist.||
0451|028|H|   Use this medication on the skin only. However, do not use it||
0451|029|H|on the face, groin or underarms unless directed to do so by your||
0451|030|H|doctor.||
0451|031|H|   Wash and dry your hands before applying. Clean and dry the||
0451|032|H|affected area. Apply a thin film of the medication to the||
0451|033|H|affected area and gently rub in as directed by your doctor,||
0451|034|H|usually 2 times daily. Do not bandage, wrap or cover the area||
0451|035|H|unless directed to do so by your doctor.||
0451|036|H|   After applying the medication, wash your hands, unless you are||
0451|037|H|using this medication to treat the hands. When applying this||
0451|038|H|medication near the eyes, avoid getting it in the eyes because||
0451|039|H|this may worsen or cause glaucoma. Also, avoid getting the||
0451|040|H|medication in your nose or mouth. If you get the medication in||
0451|041|H|your eyes, nose, or mouth, rinse with plenty of water.||
0451|042|H|   Do not apply more than 50 grams (50 milliliters or 1.75||
0451|043|H|ounces) in a given week unless directed by your doctor. Doing so||
0451|044|H|increases the risk of serious side effects.||
0451|045|H|   Use this medication only for the condition prescribed. Do not||
0451|046|H|use for longer than 4 weeks unless directed by your doctor. Tell||
0451|047|H|your doctor if you condition does not get better after 2 weeks or||
0451|048|H|if it gets worse.||
0451|049|B|||
0451|050|S|SIDE EFFECTS:  Burning, stinging, itching, irritation, dryness,||
0451|051|S|or redness may occur when this medication is first applied to the||
0451|052|S|skin. This should disappear in a few days as your body adjusts to||
0451|053|S|the medication. If any of these effects last or get worse, notify||
0451|054|S|your doctor or pharmacist promptly.||
0451|055|S|   Remember that this medication has been prescribed because your||
0451|056|S|doctor has judged that the benefit to you is greater than the||
0451|057|S|risk of side effects. Many people using this medication do not||
0451|058|S|have serious side effects.||
0451|059|S|   Tell your doctor right away if you have any serious side||
0451|060|S|effects, including: stretch marks (striae), skin||
0451|061|S|thinning/discoloration, excessive hair growth, acne, small red||
0451|062|S|bumps on the skin (folliculitis).||
0451|063|S|   Skin infections can become worse when using this medication.||
0451|064|S|Notify your doctor if redness, swelling or irritation does not||
0451|065|S|improve.||
0451|066|S|   Rarely, it is possible this medication will be absorbed from||
0451|067|S|the skin into the bloodstream. This can lead to side effects of||
0451|068|S|too much corticosteroid. These side effects are more likely in||
0451|069|S|children, and in people who use this medication for a long time||
0451|070|S|or over large areas of the skin. Tell your doctor right away if||
0451|071|S|any of the following side effects occur: unusual/extreme||
0451|072|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0451|073|S|thirst/urination, vision problems.||
0451|074|S|   A very serious allergic reaction to this drug is rare.||
0451|075|S|However, get medical help right away if you notice any symptoms||
0451|076|S|of a serious allergic reaction, including: rash, itching/swelling||
0451|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0451|078|S|breathing.||
0451|079|S|   This is not a complete list of possible side effects. If you||
0451|080|S|notice other effects not listed above, contact your doctor or||
0451|081|S|pharmacist.||
0451|082|S|   In the US -||
0451|083|S|   Call your doctor for medical advice about side effects. You||
0451|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0451|085|S|www.fda.gov/medwatch.||
0451|086|S|   In Canada - Call your doctor for medical advice about side||
0451|087|S|effects. You may report side effects to Health Canada at||
0451|088|S|1-866-234-2345.||
0451|089|B|||
0451|090|P|PRECAUTIONS:  Before using clobetasol, tell your doctor or||
0451|091|P|pharmacist if you are allergic to it; or to any other steroids||
0451|092|P|(such as hydrocortisone, dexamethasone); or if you have any other||
0451|093|P|allergies. This product may contain inactive ingredients, which||
0451|094|P|can cause allergic reactions or other problems. Talk to your||
0451|095|P|pharmacist for more details.||
0451|096|P|   Before using this medication, tell your doctor or pharmacist||
0451|097|P|your medical history, especially of: poor blood circulation,||
0451|098|P|diabetes, other skin conditions (such as rosacea, perioral||
0451|099|P|dermatitis), immune system problems.||
0451|100|P|   Do not use if there is an infection or sore in the area to be||
0451|101|P|treated.||
0451|102|P|   Rarely, using corticosteroid medications for a long time or||
0451|103|P|over large areas of skin can make it more difficult for your body||
0451|104|P|to respond to physical stress. Before having surgery or emergency||
0451|105|P|treatment, or if you get a serious illness/injury, tell your||
0451|106|P|doctor or dentist that you are using this medication or have used||
0451|107|P|this medication within the past few months.||
0451|108|P|   Though it is unlikely, this medication may temporarily slow||
0451|109|P|down a child's growth if used for a long time. See the doctor||
0451|110|P|regularly so your child's height can be checked.||
0451|111|P|   During pregnancy, this medication should be used only when||
0451|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
0451|113|P|   It is unknown if this drug passes into breast milk when||
0451|114|P|applied to the skin. Similar medications pass into breast milk||
0451|115|P|when taken by mouth. Consult your doctor before breastfeeding.||
0451|116|B|||
0451|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0451|118|I|medications work or increase your risk for serious side effects.||
0451|119|I|This document does not contain all possible drug interactions.||
0451|120|I|Keep a list of all the products you use (including||
0451|121|I|prescription/nonprescription drugs and herbal products) and share||
0451|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
0451|123|I|the dosage of any medicines without your doctor's approval.||
0451|124|B|||
0451|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0451|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0451|127|O|poison control center right away. US residents can call||
0451|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0451|129|O|medication can be harmful if swallowed.||
0451|130|B|||
0451|131|N|NOTES:  Do not share this medication with others. This medication||
0451|132|N|has been prescribed for your current condition only. Do not use||
0451|133|N|it later for other skin problems unless told to do so by your||
0451|134|N|doctor. A different medication may be necessary in those cases.||
0451|135|N|   Lab and/or medical tests (such as adrenal gland function) may||
0451|136|N|be done while you are using this medication, especially if you||
0451|137|N|use this drug for an extended period of time or apply it over||
0451|138|N|large areas of the body. Keep all medical and lab appointments.||
0451|139|N|Consult your doctor for more details.||
0451|140|B|||
0451|141|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0451|142|D|If it is near the time of the next dose, skip the missed dose.||
0451|143|D|Use your next dose at the regular time. Do not double the dose to||
0451|144|D|catch up.||
0451|145|B|||
0451|146|R|STORAGE:  Store at room temperature. Avoid freezing. Keep all||
0451|147|R|medications away from children and pets.||
0451|148|R|   Do not flush medications down the toilet or pour them into a||
0451|149|R|drain unless instructed to do so. Properly discard this product||
0451|150|R|when it is expired or no longer needed. Consult your pharmacist||
0451|151|R|or local waste disposal company.||
0451|152|B|||
0451|153|A|Information last revised November 2024.||
0451|154|A|Copyright(c) 2025 First Databank, Inc.||
0451|155|B|||
0452|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0452|002|Z|does NOT have all possible information about this product. This||
0452|003|Z|information does not assure that this product is safe, effective,||
0452|004|Z|or appropriate for you. This information is not individual||
0452|005|Z|medical advice and does not substitute for the advice of your||
0452|006|Z|health care professional. Always ask your health care||
0452|007|Z|professional for complete information about this product and your||
0452|008|Z|specific health needs.||
0452|009|B|||
0452|010|T|PREDNICARBATE OINTMENT - TOPICAL||
0452|011|F|(PRED-ni-KAR-bate)||
0452|012|B|||
0452|013|C|COMMON BRAND NAME(S): Dermatop||
0452|014|B|||
0452|015|U|USES:  This medication is used to treat a variety of skin||
0452|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0452|017|U|Prednicarbate reduces the swelling, itching and redness that can||
0452|018|U|occur in these types of conditions. This medication is a||
0452|019|U|medium-strength corticosteroid.||
0452|020|B|||
0452|021|H|HOW TO USE:  Use this medication on the skin only. However, do||
0452|022|H|not use it on the face, groin, underarms, inside the vagina, or||
0452|023|H|for diaper rash, unless directed to do so by your doctor.||
0452|024|H|   Wash and dry your hands before using. Clean and dry the||
0452|025|H|affected area. Apply a thin film of medication to the affected||
0452|026|H|area and gently rub in as directed by your doctor, usually twice||
0452|027|H|daily. Do not bandage, cover or wrap the area unless directed to||
0452|028|H|do so by your doctor.||
0452|029|H|   After applying the medication, wash your hands, unless you are||
0452|030|H|using this medication to treat the hands. When applying this||
0452|031|H|medication near the eyes, avoid getting it in the eyes because||
0452|032|H|this may worsen or cause glaucoma. Also, avoid getting this||
0452|033|H|medication in the nose or mouth. If you get the medication in||
0452|034|H|your eyes, nose, or mouth, rinse with plenty of water.||
0452|035|H|   Use this medication only for the condition prescribed.||
0452|036|H|   Tell your doctor if your condition lasts or gets worse after 2||
0452|037|H|weeks.||
0452|038|B|||
0452|039|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
0452|040|S|or redness of the skin may occur when first applied to the skin.||
0452|041|S|This should disappear in a few days as your body adjusts to the||
0452|042|S|medication. If any of these effects last or get worse, notify||
0452|043|S|your doctor or pharmacist promptly.||
0452|044|S|   Remember that this medication has been prescribed because your||
0452|045|S|doctor has judged that the benefit to you is greater than the||
0452|046|S|risk of side effects. Many people using this medication do not||
0452|047|S|have serious side effects.||
0452|048|S|   Tell your doctor right away if you have any serious side||
0452|049|S|effects, including: stretch marks, skin thinning/discoloration,||
0452|050|S|acne, excessive hair growth, small red bumps on the skin||
0452|051|S|(folliculitis).||
0452|052|S|   Skin infections can become worse when using this medication.||
0452|053|S|Notify your doctor promptly if redness, swelling or irritation||
0452|054|S|does not improve.||
0452|055|S|   Rarely, it is possible this medication will be absorbed from||
0452|056|S|the skin into the bloodstream. This can lead to side effects of||
0452|057|S|too much corticosteroid. These side effects are more likely in||
0452|058|S|children, and in people who use this medication for a long time||
0452|059|S|or over large areas of the skin. Tell your doctor right away if||
0452|060|S|any of the following side effects occur: unusual/extreme||
0452|061|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0452|062|S|thirst/urination, vision problems.||
0452|063|S|   A very serious allergic reaction to this drug is rare.||
0452|064|S|However, get medical help right away if you notice any symptoms||
0452|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0452|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0452|067|S|breathing.||
0452|068|S|   This is not a complete list of possible side effects. If you||
0452|069|S|notice other effects not listed above, contact your doctor or||
0452|070|S|pharmacist.||
0452|071|S|   In the US -||
0452|072|S|   Call your doctor for medical advice about side effects. You||
0452|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0452|074|S|www.fda.gov/medwatch.||
0452|075|S|   In Canada - Call your doctor for medical advice about side||
0452|076|S|effects. You may report side effects to Health Canada at||
0452|077|S|1-866-234-2345.||
0452|078|B|||
0452|079|P|PRECAUTIONS:  Before using prednicarbate, tell your doctor or||
0452|080|P|pharmacist if you are allergic to it; or to other corticosteroids||
0452|081|P|(such as hydrocortisone, prednisone); or if you have any other||
0452|082|P|allergies. This product may contain inactive ingredients, which||
0452|083|P|can cause allergic reactions or other problems. Talk to your||
0452|084|P|pharmacist for more details.||
0452|085|P|   Before using this medication, tell your doctor or pharmacist||
0452|086|P|your medical history, especially of: poor blood circulation,||
0452|087|P|diabetes, immune system problems, other skin conditions (such as||
0452|088|P|rosacea, perioral dermatitis).||
0452|089|P|   Do not use if there is an infection or sore in the area to be||
0452|090|P|treated.||
0452|091|P|   This medication may reduce the effectiveness of||
0452|092|P|latex-containing products (such as condoms).||
0452|093|P|   Rarely, using corticosteroid medications for a long time or||
0452|094|P|over large areas of skin can make it more difficult for your body||
0452|095|P|to respond to physical stress. Before having surgery or emergency||
0452|096|P|treatment, or if you get a serious illness/injury, tell your||
0452|097|P|doctor or dentist that you are using this medication or have used||
0452|098|P|this medication within the past few months.||
0452|099|P|   Though it is unlikely, this medication may temporarily slow||
0452|100|P|down a child's growth if used for a long time. See the doctor||
0452|101|P|regularly so your child's height can be checked.||
0452|102|P|   During pregnancy, this medication should be used only when||
0452|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
0452|104|P|   It is unknown if this drug passes into breast milk when||
0452|105|P|applied to the skin. Similar medications pass into breast milk||
0452|106|P|when taken by mouth. Consult your doctor before breastfeeding.||
0452|107|B|||
0452|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0452|109|I|medications work or increase your risk for serious side effects.||
0452|110|I|This document does not contain all possible drug interactions.||
0452|111|I|Keep a list of all the products you use (including||
0452|112|I|prescription/nonprescription drugs and herbal products) and share||
0452|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
0452|114|I|the dosage of any medicines without your doctor's approval.||
0452|115|B|||
0452|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0452|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0452|118|O|poison control center right away. US residents can call||
0452|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0452|120|O|medication may be harmful if swallowed.||
0452|121|B|||
0452|122|N|NOTES:  Do not share this medication with others. This medication||
0452|123|N|has been prescribed for your current condition only. Do not use||
0452|124|N|it later for other skin problems unless told to do so by your||
0452|125|N|doctor. A different medication may be necessary in those cases.||
0452|126|N|   Lab and/or medical tests (such as adrenal gland function) may||
0452|127|N|be done while you are using this medication, especially if you||
0452|128|N|use this drug for an extended period of time or apply it over||
0452|129|N|large areas of the body. Keep all medical and lab appointments.||
0452|130|N|Consult your doctor for more details.||
0452|131|B|||
0452|132|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0452|133|D|If it is near the time of the next dose, skip the missed dose.||
0452|134|D|Use your next dose at the regular time. Do not double the dose to||
0452|135|D|catch up.||
0452|136|B|||
0452|137|R|STORAGE:  Store at room temperature. Keep all medications away||
0452|138|R|from children and pets.||
0452|139|R|   Do not flush medications down the toilet or pour them into a||
0452|140|R|drain unless instructed to do so. Properly discard this product||
0452|141|R|when it is expired or no longer needed. Consult your pharmacist||
0452|142|R|or local waste disposal company.||
0452|143|B|||
0452|144|A|Information last revised October 2024.||
0452|145|A|Copyright(c) 2025 First Databank, Inc.||
0452|146|B|||
0453|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0453|002|Z|does NOT have all possible information about this product. This||
0453|003|Z|information does not assure that this product is safe, effective,||
0453|004|Z|or appropriate for you. This information is not individual||
0453|005|Z|medical advice and does not substitute for the advice of your||
0453|006|Z|health care professional. Always ask your health care||
0453|007|Z|professional for complete information about this product and your||
0453|008|Z|specific health needs.||
0453|009|B|||
0453|010|T|FLURANDRENOLIDE - TOPICAL||
0453|011|F|(FLUR-an-DREN-oh-lide)||
0453|012|B|||
0453|013|C|COMMON BRAND NAME(S): Cordran||
0453|014|B|||
0453|015|U|USES:  This medication is used to treat a variety of skin||
0453|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0453|017|U|Flurandrenolide reduces the swelling, itching and redness that||
0453|018|U|can occur in these types of conditions. This medication is a||
0453|019|U|medium-strength corticosteroid.||
0453|020|B|||
0453|021|H|HOW TO USE:  Use this medication on the skin only. However, do||
0453|022|H|not use it on the face, groin, or underarms unless directed to do||
0453|023|H|so by your doctor.||
0453|024|H|   Wash and dry your hands before using. Clean and dry the||
0453|025|H|affected area. Apply a thin film of medication to the affected||
0453|026|H|area and gently rub in as directed by your doctor, usually 2 to 3||
0453|027|H|times a day. Do not bandage, cover or wrap the area unless||
0453|028|H|directed to do so by your doctor.||
0453|029|H|   After applying the medication, wash your hands, unless you are||
0453|030|H|using this medication to treat the hands. When applying this||
0453|031|H|medication near the eyes, avoid getting it in the eyes because||
0453|032|H|this may worsen or cause glaucoma. Also, avoid getting this||
0453|033|H|medication in the nose or mouth. If you get the medication in||
0453|034|H|your eyes, nose, or mouth, rinse with plenty of water.||
0453|035|H|   Use this medication only for the condition prescribed.||
0453|036|H|   Tell your doctor if your condition lasts or gets worse after 2||
0453|037|H|weeks.||
0453|038|B|||
0453|039|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
0453|040|S|or redness of the skin may occur when first applied to the skin.||
0453|041|S|This should disappear in a few days as your body adjusts to the||
0453|042|S|medication. If any of these effects last or get worse, notify||
0453|043|S|your doctor or pharmacist promptly.||
0453|044|S|   Remember that this medication has been prescribed because your||
0453|045|S|doctor has judged that the benefit to you is greater than the||
0453|046|S|risk of side effects. Many people using this medication do not||
0453|047|S|have serious side effects.||
0453|048|S|   Tell your doctor right away if you have any serious side||
0453|049|S|effects, including: stretch marks, skin thinning/discoloration,||
0453|050|S|acne, excessive hair growth, small red bumps on the skin||
0453|051|S|(folliculitis).||
0453|052|S|   Skin infections can become worse when using this medication.||
0453|053|S|Notify your doctor promptly if redness, swelling or irritation||
0453|054|S|does not improve.||
0453|055|S|   Rarely, it is possible this medication will be absorbed from||
0453|056|S|the skin into the bloodstream. This can lead to side effects of||
0453|057|S|too much corticosteroid. These side effects are more likely in||
0453|058|S|children, and in people who use this medication for a long time||
0453|059|S|or over large areas of the skin. Tell your doctor right away if||
0453|060|S|any of the following side effects occur: unusual/extreme||
0453|061|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0453|062|S|thirst/urination, vision problems.||
0453|063|S|   A very serious allergic reaction to this drug is rare.||
0453|064|S|However, get medical help right away if you notice any symptoms||
0453|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0453|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0453|067|S|breathing.||
0453|068|S|   This is not a complete list of possible side effects. If you||
0453|069|S|notice other effects not listed above, contact your doctor or||
0453|070|S|pharmacist.||
0453|071|S|   In the US -||
0453|072|S|   Call your doctor for medical advice about side effects. You||
0453|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0453|074|S|www.fda.gov/medwatch.||
0453|075|S|   In Canada - Call your doctor for medical advice about side||
0453|076|S|effects. You may report side effects to Health Canada at||
0453|077|S|1-866-234-2345.||
0453|078|B|||
0453|079|P|PRECAUTIONS:  Before using flurandrenolide, tell your doctor or||
0453|080|P|pharmacist if you are allergic to it; or to other corticosteroids||
0453|081|P|(such as hydrocortisone, prednisone); or if you have any other||
0453|082|P|allergies. This product may contain inactive ingredients, which||
0453|083|P|can cause allergic reactions or other problems. Talk to your||
0453|084|P|pharmacist for more details.||
0453|085|P|   Before using this medication, tell your doctor or pharmacist||
0453|086|P|your medical history, especially of: poor blood circulation,||
0453|087|P|diabetes, immune system problems, other skin conditions (such as||
0453|088|P|rosacea, perioral dermatitis).||
0453|089|P|   Do not use if there is an infection or sore in the area to be||
0453|090|P|treated.||
0453|091|P|   Rarely, using corticosteroid medications for a long time or||
0453|092|P|over large areas of skin can make it more difficult for your body||
0453|093|P|to respond to physical stress. Before having surgery or emergency||
0453|094|P|treatment, or if you get a serious illness/injury, tell your||
0453|095|P|doctor or dentist that you are using this medication or have used||
0453|096|P|this medication within the past few months.||
0453|097|P|   Though it is unlikely, this medication may temporarily slow||
0453|098|P|down a child's growth if used for a long time. See the doctor||
0453|099|P|regularly so your child's height can be checked.||
0453|100|P|   During pregnancy, this medication should be used only when||
0453|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
0453|102|P|   It is unknown if this drug passes into breast milk when||
0453|103|P|applied to the skin. Similar medications pass into breast milk||
0453|104|P|when taken by mouth. Consult your doctor before breastfeeding.||
0453|105|B|||
0453|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0453|107|I|medications work or increase your risk for serious side effects.||
0453|108|I|This document does not contain all possible drug interactions.||
0453|109|I|Keep a list of all the products you use (including||
0453|110|I|prescription/nonprescription drugs and herbal products) and share||
0453|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0453|112|I|the dosage of any medicines without your doctor's approval.||
0453|113|B|||
0453|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0453|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0453|116|O|poison control center right away. US residents can call||
0453|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0453|118|O|medication may be harmful if swallowed.||
0453|119|B|||
0453|120|N|NOTES:  Do not share this medication with others. This medication||
0453|121|N|has been prescribed for your current condition only. Do not use||
0453|122|N|it later for other skin problems unless told to do so by your||
0453|123|N|doctor. A different medication may be necessary in those cases.||
0453|124|N|   Lab and/or medical tests (such as adrenal gland function) may||
0453|125|N|be done while you are using this medication, especially if you||
0453|126|N|use this drug for an extended period of time or apply it over||
0453|127|N|large areas of the body. Keep all medical and lab appointments.||
0453|128|N|Consult your doctor for more details.||
0453|129|B|||
0453|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0453|131|D|If it is near the time of the next dose, skip the missed dose.||
0453|132|D|Use your next dose at the regular time. Do not double the dose to||
0453|133|D|catch up.||
0453|134|B|||
0453|135|R|STORAGE:  Store at room temperature. Keep all medications away||
0453|136|R|from children and pets.||
0453|137|R|   Do not flush medications down the toilet or pour them into a||
0453|138|R|drain unless instructed to do so. Properly discard this product||
0453|139|R|when it is expired or no longer needed. Consult your pharmacist||
0453|140|R|or local waste disposal company.||
0453|141|B|||
0453|142|A|Information last revised October 2024.||
0453|143|A|Copyright(c) 2025 First Databank, Inc.||
0453|144|B|||
0454|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0454|002|Z|does NOT have all possible information about this product. This||
0454|003|Z|information does not assure that this product is safe, effective,||
0454|004|Z|or appropriate for you. This information is not individual||
0454|005|Z|medical advice and does not substitute for the advice of your||
0454|006|Z|health care professional. Always ask your health care||
0454|007|Z|professional for complete information about this product and your||
0454|008|Z|specific health needs.||
0454|009|B|||
0454|010|T|ACEBUTOLOL - ORAL||
0454|011|F|(A-se-BUE-toe-lol)||
0454|012|B|||
0454|013|C|COMMON BRAND NAME(S): Sectral||
0454|014|B|||
0454|015|W|WARNING:  Do not stop taking this medication without consulting||
0454|016|W|your doctor. Some conditions may become worse when you suddenly||
0454|017|W|stop this drug. Some people who have suddenly stopped taking||
0454|018|W|similar drugs have had chest pain, heart attack, and irregular||
0454|019|W|heartbeat. If your doctor decides you should no longer use this||
0454|020|W|drug, your doctor may direct you to gradually decrease your dose||
0454|021|W|over 1 to 2 weeks.||
0454|022|W|   When gradually stopping this medication, it is recommended||
0454|023|W|that you temporarily limit physical activity to decrease strain||
0454|024|W|on the heart. Get medical help right away if you develop chest||
0454|025|W|pain/tightness/pressure, chest pain spreading to the||
0454|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
0454|027|W|fast/irregular heartbeat.||
0454|028|B|||
0454|029|U|USES:  Acebutolol is used to treat high blood pressure and||
0454|030|U|irregular heartbeat (arrhythmia). Lowering high blood pressure||
0454|031|U|helps prevent strokes, heart attacks, and kidney problems.||
0454|032|U|Treating irregular heartbeat helps the heart work better and with||
0454|033|U|less strain. Irregular heartbeats can be serious and may||
0454|034|U|sometimes even lead to a heart attack.||
0454|035|U|   This medication belongs to a class of drugs known as beta||
0454|036|U|blockers. It works by blocking the action of certain natural||
0454|037|U|substances in your body, such as epinephrine, on the heart and||
0454|038|U|blood vessels. This effect lowers heart rate, blood pressure, and||
0454|039|U|strain on the heart.||
0454|040|B|||
0454|041|V|OTHER USES:  This section contains uses of this drug that are not||
0454|042|V|listed in the approved professional labeling for the drug but||
0454|043|V|that may be prescribed by your health care professional. Use this||
0454|044|V|drug for a condition that is listed in this section only if it||
0454|045|V|has been so prescribed by your health care professional.||
0454|046|V|   This drug may also be used after a heart attack to improve||
0454|047|V|survival. It may also be used to reduce the risk of chest pain||
0454|048|V|(angina).||
0454|049|B|||
0454|050|H|HOW TO USE:  See also Warning section.||
0454|051|H|   Take this medication by mouth with or without food as directed||
0454|052|H|by your doctor, usually once or twice daily. The dosage is based||
0454|053|H|on your medical condition and response to treatment.||
0454|054|H|   Use this medication regularly to get the most benefit from it.||
0454|055|H|To help you remember, take it at the same time(s) each day.||
0454|056|H|   For the treatment of high blood pressure, it may take several||
0454|057|H|weeks before you get the full benefit of this drug. Keep taking||
0454|058|H|this medication even if you feel well. Most people with high||
0454|059|H|blood pressure do not feel sick.||
0454|060|H|   Tell your doctor if your condition does not get better or if||
0454|061|H|it gets worse (for example, your blood pressure readings remain||
0454|062|H|high or increase).||
0454|063|B|||
0454|064|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
0454|065|S|   Tiredness, dizziness, lightheadedness, nausea, upset stomach,||
0454|066|S|slow heartbeat, or trouble sleeping may occur. If any of these||
0454|067|S|effects last or get worse, tell your doctor or pharmacist||
0454|068|S|promptly.||
0454|069|S|   To reduce the risk of dizziness and lightheadedness, get up||
0454|070|S|slowly when rising from a sitting or lying position.||
0454|071|S|   This drug may reduce blood flow to your hands and feet,||
0454|072|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0454|073|S|warmly and avoid tobacco use.||
0454|074|S|   Remember that this medication has been prescribed because your||
0454|075|S|doctor has judged that the benefit to you is greater than the||
0454|076|S|risk of side effects. Many people using this medication do not||
0454|077|S|have serious side effects.||
0454|078|S|   Tell your doctor right away if you have any serious side||
0454|079|S|effects, including: symptoms of asthma (for example, feelings of||
0454|080|S|tightness in the chest, shortness of breath, cough, wheezing),||
0454|081|S|blue fingers/toes, fainting, very slow heartbeat, new or||
0454|082|S|worsening symptoms of heart failure (such as shortness of breath,||
0454|083|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
0454|084|S|gain), mental/mood changes (such as confusion, depression, memory||
0454|085|S|problems), vision changes, symptoms of liver disease (such as||
0454|086|S|nausea that doesn't stop, dark urine, vomiting, stomach/abdominal||
0454|087|S|pain, yellowing eyes/skin).||
0454|088|S|   A very serious allergic reaction to this drug is rare.||
0454|089|S|However, get medical help right away if you notice any symptoms||
0454|090|S|of a serious allergic reaction, including: rash, itching/swelling||
0454|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0454|092|S|breathing.||
0454|093|S|   This is not a complete list of possible side effects. If you||
0454|094|S|notice other effects not listed above, contact your doctor or||
0454|095|S|pharmacist.||
0454|096|S|   In the US -||
0454|097|S|   Call your doctor for medical advice about side effects. You||
0454|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0454|099|S|www.fda.gov/medwatch.||
0454|100|S|   In Canada - Call your doctor for medical advice about side||
0454|101|S|effects. You may report side effects to Health Canada at||
0454|102|S|1-866-234-2345.||
0454|103|B|||
0454|104|P|PRECAUTIONS:  Before taking acebutolol, tell your doctor or||
0454|105|P|pharmacist if you are allergic to it; or if you have any other||
0454|106|P|allergies. This product may contain inactive ingredients, which||
0454|107|P|can cause allergic reactions or other problems. Talk to your||
0454|108|P|pharmacist for more details.||
0454|109|P|   Before using this medication, tell your doctor or pharmacist||
0454|110|P|your medical history, especially of: blood circulation problems||
0454|111|P|(such as Raynaud's disease, peripheral vascular disease),||
0454|112|P|breathing problems (such as asthma, chronic bronchitis,||
0454|113|P|emphysema), heart problems (such as heart failure, previous heart||
0454|114|P|attack, heart rhythm problems), kidney problems, liver problems,||
0454|115|P|mental/mood disorders (such as depression), a certain muscle||
0454|116|P|disease (myasthenia gravis), overactive thyroid disease||
0454|117|P|(hyperthyroidism), serious allergic reactions, including those||
0454|118|P|needing treatment with epinephrine.||
0454|119|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0454|120|P|can make you more dizzy. Do not drive, use machinery, or do||
0454|121|P|anything that needs alertness until you can do it safely. Limit||
0454|122|P|alcoholic beverages. Talk to your doctor if you are using||
0454|123|P|marijuana (cannabis).||
0454|124|P|   Before having surgery, tell your doctor or dentist about all||
0454|125|P|the products you use (including prescription drugs,||
0454|126|P|nonprescription drugs, and herbal products).||
0454|127|P|   This product may prevent the fast/pounding heartbeat you would||
0454|128|P|usually feel when your blood sugar level falls too low||
0454|129|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0454|130|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0454|131|P|blood sugar level, such as dizziness and sweating, are not||
0454|132|P|affected by this drug.||
0454|133|P|   If you have diabetes, this product may make it harder to||
0454|134|P|control your blood sugar levels. Check your blood sugar levels||
0454|135|P|regularly as directed by your doctor. Tell your doctor right away||
0454|136|P|if you have symptoms of high blood sugar such as increased||
0454|137|P|thirst/urination. Your doctor may need to adjust your diabetes||
0454|138|P|medication, exercise program, or diet.||
0454|139|P|   Children may be at greater risk for low blood sugar||
0454|140|P|(hypoglycemia) while using this drug, especially if they are||
0454|141|P|vomiting or not eating regularly. To help prevent low blood||
0454|142|P|sugar, make sure children eat regularly. If your child cannot eat||
0454|143|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
0454|144|P|as sweating, shaking), tell the doctor right away.||
0454|145|P|   During pregnancy, this medication should be used only when||
0454|146|P|clearly needed. Babies born to mothers taking this drug during||
0454|147|P|pregnancy may have a low birth weight and require monitoring for||
0454|148|P|problems such as low blood pressure and slow heartbeat. Discuss||
0454|149|P|the risks and benefits with your doctor.||
0454|150|P|   This drug passes into breast milk. Consult your doctor before||
0454|151|P|breastfeeding.||
0454|152|B|||
0454|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0454|154|I|medications work or increase your risk for serious side effects.||
0454|155|I|This document does not contain all possible drug interactions.||
0454|156|I|Keep a list of all the products you use (including||
0454|157|I|prescription/nonprescription drugs and herbal products) and share||
0454|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
0454|159|I|the dosage of any medicines without your doctor's approval.||
0454|160|I|   A product that may interact with this drug is: fingolimod.||
0454|161|I|   Some products have ingredients that could raise your heart||
0454|162|I|rate or blood pressure. Tell your pharmacist what products you||
0454|163|I|are using, and ask how to use them safely (especially||
0454|164|I|cough-and-cold products, diet aids, or NSAIDs such as||
0454|165|I|ibuprofen/naproxen).||
0454|166|B|||
0454|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0454|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0454|169|O|poison control center right away. US residents can call||
0454|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0454|171|O|Symptoms of overdose may include: unusually slow heartbeat,||
0454|172|O|fainting, severe weakness.||
0454|173|B|||
0454|174|N|NOTES:  Do not share this medication with others.||
0454|175|N|   Lifestyle changes such as stress reduction programs, exercise,||
0454|176|N|and dietary changes may increase the effectiveness of this||
0454|177|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0454|178|N|changes that might benefit you.||
0454|179|N|   Check your blood pressure and pulse (heart rate) regularly||
0454|180|N|while taking this medication. Learn how to check your blood||
0454|181|N|pressure and pulse at home, and share the results with your||
0454|182|N|doctor.||
0454|183|B|||
0454|184|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0454|185|D|remember. If it is near the time of the next dose, skip the||
0454|186|D|missed dose. Take your next dose at the regular time. Do not||
0454|187|D|double the dose to catch up.||
0454|188|B|||
0454|189|R|STORAGE:  Store at room temperature away from light and moisture.||
0454|190|R|Do not store in the bathroom. Keep all medications away from||
0454|191|R|children and pets.||
0454|192|R|   Do not flush medications down the toilet or pour them into a||
0454|193|R|drain unless instructed to do so. Properly discard this product||
0454|194|R|when it is expired or no longer needed. Consult your pharmacist||
0454|195|R|or local waste disposal company.||
0454|196|B|||
0454|197|M|MEDICAL ALERT:  Your condition can cause complications in a||
0454|198|M|medical emergency. For information about enrolling in MedicAlert,||
0454|199|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0454|200|B|||
0454|201|A|Information last revised May 2024.||
0454|202|A|Copyright(c) 2025 First Databank, Inc.||
0454|203|B|||
0455|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0455|002|Z|does NOT have all possible information about this product. This||
0455|003|Z|information does not assure that this product is safe, effective,||
0455|004|Z|or appropriate for you. This information is not individual||
0455|005|Z|medical advice and does not substitute for the advice of your||
0455|006|Z|health care professional. Always ask your health care||
0455|007|Z|professional for complete information about this product and your||
0455|008|Z|specific health needs.||
0455|009|B|||
0455|010|T|AMOXAPINE - ORAL||
0455|011|F|(a-MOX-a-peen)||
0455|012|B|||
0455|013|C|COMMON BRAND NAME(S): Asendin||
0455|014|B|||
0455|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0455|016|W|of conditions, including depression and other mental/mood||
0455|017|W|disorders. These medications can help prevent suicidal||
0455|018|W|thoughts/attempts and provide other important benefits. However,||
0455|019|W|studies have shown that a small number of people (especially||
0455|020|W|people younger than 25) who take antidepressants for any||
0455|021|W|condition may experience worsening depression, other mental/mood||
0455|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0455|023|W|talk with the doctor about the risks and benefits of||
0455|024|W|antidepressant medication (especially for people younger than||
0455|025|W|25), even if treatment is not for a mental/mood condition.||
0455|026|W|   Tell the doctor right away if you notice worsening||
0455|027|W|depression/other psychiatric conditions, unusual behavior changes||
0455|028|W|(including possible suicidal thoughts/attempts), or other||
0455|029|W|mental/mood changes (including new/worsening anxiety, panic||
0455|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0455|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0455|032|W|especially watchful for these symptoms when a new antidepressant||
0455|033|W|is started or when the dose is changed.||
0455|034|B|||
0455|035|U|USES:  This medication is used to treat certain mental/mood||
0455|036|U|disorders (such as depression, anxiety along with depression).||
0455|037|U|Amoxapine belongs to a class of drugs known as tricyclic||
0455|038|U|antidepressants. It works by helping to restore the balance of||
0455|039|U|certain natural substances in the brain.||
0455|040|B|||
0455|041|V|OTHER USES:  This section contains uses of this drug that are not||
0455|042|V|listed in the approved professional labeling for the drug but||
0455|043|V|that may be prescribed by your health care professional. Use this||
0455|044|V|drug for a condition that is listed in this section only if it||
0455|045|V|has been so prescribed by your health care professional.||
0455|046|V|   This drug may also be used for anxiety disorders (such as||
0455|047|V|panic disorder) and bipolar disorder.||
0455|048|B|||
0455|049|H|HOW TO USE:  Read the Medication Guide provided by your||
0455|050|H|pharmacist before you start taking amoxapine and each time you||
0455|051|H|get a refill. If you have any questions, ask your doctor or||
0455|052|H|pharmacist.||
0455|053|H|   Take this medication by mouth with or without food as directed||
0455|054|H|by your doctor, usually 1 to 3 times daily. To lessen side||
0455|055|H|effects, amoxapine may be started at a low dose and slowly||
0455|056|H|increased as your body gets used to it. Follow your doctor's||
0455|057|H|instructions carefully. If you are taking this medication once||
0455|058|H|daily, it is usually taken at bedtime to prevent daytime||
0455|059|H|drowsiness. The dosage is based on your medical condition, age,||
0455|060|H|and response to treatment.||
0455|061|H|   Use this medication regularly in order to get the most benefit||
0455|062|H|from it. To help you remember, use it at the same time(s) each||
0455|063|H|day. This medication does not work right away. It may take up to||
0455|064|H|two weeks before you experience the full benefits.||
0455|065|H|   Keep taking this medication even if you feel well. Do not||
0455|066|H|suddenly stop taking this medication without consulting your||
0455|067|H|doctor. Some conditions may become worse when the drug is||
0455|068|H|abruptly stopped. Your dose may need to be gradually decreased.||
0455|069|H|   Tell your doctor if your condition does not get better or if||
0455|070|H|it gets worse.||
0455|071|B|||
0455|072|S|SIDE EFFECTS:  See also the Warning section.||
0455|073|S|   Drowsiness, dizziness, difficulty urinating, dry mouth,||
0455|074|S|constipation, headache, weakness, blurred vision, or changes in||
0455|075|S|appetite/weight may occur as your body gets used to the||
0455|076|S|medication. If any of these effects last or get worse, tell your||
0455|077|S|doctor or pharmacist promptly.||
0455|078|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0455|079|S|chips, chew (sugarless) gum, drink water or use a saliva||
0455|080|S|substitute. If any of these effects last or get worse, notify||
0455|081|S|your doctor or pharmacist promptly.||
0455|082|S|   To prevent constipation, eat dietary fiber, drink enough||
0455|083|S|water, and exercise. You may also need to take a laxative. Ask||
0455|084|S|your pharmacist which type of laxative is right for you.||
0455|085|S|   To reduce the risk of dizziness and lightheadedness, get up||
0455|086|S|slowly when rising from a sitting or lying position.||
0455|087|S|   Remember that this medication has been prescribed because your||
0455|088|S|doctor has judged that the benefit to you is greater than the||
0455|089|S|risk of side effects. Many people using this medication do not||
0455|090|S|have serious side effects.||
0455|091|S|   Tell your doctor right away if you have any serious side||
0455|092|S|effects, including: fainting, mental/mood changes (such as||
0455|093|S|confusion, depression, hallucinations, nervousness,||
0455|094|S|restlessness), numbness/tingling of the hands/feet, ringing in||
0455|095|S|the ears, shakiness (tremors), stomach/abdominal pain, severe||
0455|096|S|vomiting/constipation.||
0455|097|S|   Get medical help right away if you have any very serious side||
0455|098|S|effects, including: chest/jaw/left arm pain, slow/fast/irregular||
0455|099|S|heartbeat, pain/redness/swelling of arms/legs, seizures, severe||
0455|100|S|headache, weakness on one side of the body, eye||
0455|101|S|pain/swelling/redness, widened pupils, vision changes (such as||
0455|102|S|seeing rainbows around lights at night), trouble speaking.||
0455|103|S|   In rare instances, this medication may increase your level of||
0455|104|S|a certain natural chemical made by the body (prolactin). For||
0455|105|S|females, this increase in prolactin may result in unwanted breast||
0455|106|S|milk, missing/stopped periods, or difficulty becoming pregnant.||
0455|107|S|For males, it may result in decreased sexual ability, inability||
0455|108|S|to produce sperm, or enlarged breasts. If you develop any of||
0455|109|S|these symptoms, tell your doctor right away.||
0455|110|S|   This drug may rarely cause a condition known as tardive||
0455|111|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0455|112|S|your doctor right away if you develop any unusual/uncontrolled||
0455|113|S|movements (especially of the face, mouth, tongue, arms or legs).||
0455|114|S|   Amoxapine may rarely cause a serious condition called||
0455|115|S|neuroleptic malignant syndrome. Get medical help right away if||
0455|116|S|you develop the following: fever, muscle stiffness, increased||
0455|117|S|sweating, fast/irregular heartbeat, severe confusion.||
0455|118|S|   This medication may rarely cause serious blood problems (such||
0455|119|S|as agranulocytosis, thrombocytopenia) or liver problems. Get||
0455|120|S|medical help right away if you notice any of the following very||
0455|121|S|serious side effects: easy bleeding/bruising, signs of infection||
0455|122|S|(such as sore throat that doesn't go away, fever, chills), severe||
0455|123|S|stomach/abdominal pain, dark urine, yellowing of the eyes/skin.||
0455|124|S|   A very serious allergic reaction to this drug is rare.||
0455|125|S|However, get medical help right away if you notice any symptoms||
0455|126|S|of a serious allergic reaction, including: rash, itching/swelling||
0455|127|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0455|128|S|breathing.||
0455|129|S|   This is not a complete list of possible side effects. If you||
0455|130|S|notice other effects not listed above, contact your doctor or||
0455|131|S|pharmacist.||
0455|132|S|   In the US -||
0455|133|S|   Call your doctor for medical advice about side effects. You||
0455|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0455|135|S|www.fda.gov/medwatch.||
0455|136|S|   In Canada - Call your doctor for medical advice about side||
0455|137|S|effects. You may report side effects to Health Canada at||
0455|138|S|1-866-234-2345.||
0455|139|B|||
0455|140|P|PRECAUTIONS:  See also the Warning section.||
0455|141|P|   Before taking amoxapine, tell your doctor or pharmacist if you||
0455|142|P|are allergic to it; or to other tricyclic antidepressants (such||
0455|143|P|as amitriptyline); or if you have any other allergies. This||
0455|144|P|product may contain inactive ingredients, which can cause||
0455|145|P|allergic reactions or other problems. Talk to your pharmacist for||
0455|146|P|more details.||
0455|147|P|   Before using this medication, tell your doctor or pharmacist||
0455|148|P|your medical history, especially of: blood problems (such as||
0455|149|P|agranulocytosis, thrombocytopenia), breathing problems (such as||
0455|150|P|asthma, COPD), personal or family history of glaucoma||
0455|151|P|(angle-closure type), intestinal problems (such as chronic||
0455|152|P|constipation, ileus), heart problems (such as recent heart||
0455|153|P|attack, arrhythmias, coronary artery disease, heart failure),||
0455|154|P|kidney problems, liver problems, other mental/mood conditions||
0455|155|P|(such as bipolar disorder, psychosis), family history of||
0455|156|P|mental/mood conditions (such as bipolar disorder) or suicide,||
0455|157|P|history of neuroleptic malignant syndrome, movement disorders||
0455|158|P|(such as Parkinson's disease, tardive dyskinesia), overactive||
0455|159|P|thyroid (hyperthyroidism), problems urinating (urinary retention,||
0455|160|P|enlarged prostate), seizures, conditions that may increase your||
0455|161|P|risk of seizures (such as electroshock therapy, stroke, alcohol||
0455|162|P|withdrawal).||
0455|163|P|   This drug may make you dizzy or drowsy or blur your vision.||
0455|164|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0455|165|P|drowsy. Do not drive, use machinery, or do anything that needs||
0455|166|P|alertness or clear vision until you can do it safely. Limit||
0455|167|P|alcoholic beverages. Talk to your doctor if you are using||
0455|168|P|marijuana (cannabis).||
0455|169|P|   Before having surgery, tell your doctor or dentist about all||
0455|170|P|the products you use (including prescription drugs,||
0455|171|P|nonprescription drugs, and herbal products).||
0455|172|P|   This medication may make you more sensitive to the sun. Limit||
0455|173|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0455|174|P|sunscreen and wear protective clothing when outdoors. Tell your||
0455|175|P|doctor right away if you get sunburned or have skin||
0455|176|P|blisters/redness.||
0455|177|P|   Older adults may be more sensitive to the side effects of this||
0455|178|P|drug, especially drowsiness, dizziness, confusion, constipation,||
0455|179|P|trouble urinating, and involuntary movements (tardive||
0455|180|P|dyskinesia). Drowsiness, dizziness, and confusion can increase||
0455|181|P|the risk of falling.||
0455|182|P|   During pregnancy, this medication should be used only when||
0455|183|P|clearly needed. Infants born to mothers who have taken similar||
0455|184|P|medications during pregnancy may have problems such as very deep||
0455|185|P|sleep, trouble urinating, shaking (tremors), and seizures.||
0455|186|P|Discuss the risks and benefits with your doctor.||
0455|187|P|   Since untreated mental/mood problems (such as depression,||
0455|188|P|panic disorders, bipolar disorder) can be a serious condition, do||
0455|189|P|not stop taking this medication unless directed by your doctor.||
0455|190|P|If you are planning pregnancy, become pregnant, or think you may||
0455|191|P|be pregnant, immediately discuss with your doctor the benefits||
0455|192|P|and risks of using this medication during pregnancy.||
0455|193|P|   This medication passes into breast milk and may have||
0455|194|P|undesirable effects on a nursing infant. Consult your doctor||
0455|195|P|before breastfeeding.||
0455|196|B|||
0455|197|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0455|198|I|medications work or increase your risk for serious side effects.||
0455|199|I|This document does not contain all possible drug interactions.||
0455|200|I|Keep a list of all the products you use (including||
0455|201|I|prescription/nonprescription drugs and herbal products) and share||
0455|202|I|it with your doctor and pharmacist. Do not start, stop, or change||
0455|203|I|the dosage of any medicines without your doctor's approval.||
0455|204|I|   Some products that may interact with this drug include:||
0455|205|I|certain drugs for high blood pressure (such as clonidine,||
0455|206|I|guanethidine), psychiatric drugs (such as antipsychotics,||
0455|207|I|antidepressants), thyroid supplements.||
0455|208|I|   Taking MAO inhibitors with this medication may cause a serious||
0455|209|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0455|210|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0455|211|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0455|212|I|selegiline, tranylcypromine) during treatment with this||
0455|213|I|medication. Most MAO inhibitors should also not be taken for two||
0455|214|I|weeks before treatment with this medication. Ask your doctor when||
0455|215|I|to start or stop taking this medication.||
0455|216|I|   Tell your doctor or pharmacist if you are taking other||
0455|217|I|products that cause drowsiness such as opioid pain or cough||
0455|218|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0455|219|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0455|220|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0455|221|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0455|222|I|diphenhydramine).||
0455|223|I|   Check the labels on all your medicines (such as allergy or||
0455|224|I|cough-and-cold products) because they may contain ingredients||
0455|225|I|that cause drowsiness. Ask your pharmacist about using those||
0455|226|I|products safely.||
0455|227|I|   This medication may interfere with certain medical/lab tests||
0455|228|I|(such as brain scan for Parkinson's disease), possibly causing||
0455|229|I|false test results. Make sure lab personnel and all your doctors||
0455|230|I|know you use this drug.||
0455|231|B|||
0455|232|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0455|233|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0455|234|O|poison control center right away. US residents can call||
0455|235|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0455|236|O|Overdose of this medication may be fatal and symptoms include:||
0455|237|O|seizures, delirium, and loss of consciousness .||
0455|238|B|||
0455|239|N|NOTES:  Do not share this medication with others.||
0455|240|N|   Lab and/or medical tests may be done while you are taking this||
0455|241|N|medication. Keep all medical and lab appointments. Consult your||
0455|242|N|doctor for more details.||
0455|243|B|||
0455|244|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0455|245|D|remember. If it is near the time of the next dose, skip the||
0455|246|D|missed dose. Take your next dose at the regular time. Do not||
0455|247|D|double the dose to catch up.||
0455|248|B|||
0455|249|R|STORAGE:  Store at room temperature away from light and moisture.||
0455|250|R|Do not store in the bathroom. Keep all medications away from||
0455|251|R|children and pets.||
0455|252|R|   Do not flush medications down the toilet or pour them into a||
0455|253|R|drain unless instructed to do so. Properly discard this product||
0455|254|R|when it is expired or no longer needed. Consult your pharmacist||
0455|255|R|or local waste disposal company.||
0455|256|B|||
0455|257|A|Information last revised April 2025.||
0455|258|A|Copyright(c) 2025 First Databank, Inc.||
0455|259|B|||
0457|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0457|002|Z|does NOT have all possible information about this product. This||
0457|003|Z|information does not assure that this product is safe, effective,||
0457|004|Z|or appropriate for you. This information is not individual||
0457|005|Z|medical advice and does not substitute for the advice of your||
0457|006|Z|health care professional. Always ask your health care||
0457|007|Z|professional for complete information about this product and your||
0457|008|Z|specific health needs.||
0457|009|B|||
0457|010|T|FENOPROFEN - ORAL||
0457|011|F|(FEN-oh-PROE-fen)||
0457|012|B|||
0457|013|C|COMMON BRAND NAME(S): Nalfon||
0457|014|B|||
0457|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0457|016|W|fenoprofen) may rarely increase the risk of a heart attack or||
0457|017|W|stroke. This effect can happen at any time while taking this drug||
0457|018|W|but is more likely if you take it for a long time. The risk may||
0457|019|W|be greater in older adults or if you have heart disease or||
0457|020|W|increased risk for heart disease (for example, due to smoking,||
0457|021|W|family history of heart disease, or conditions such as high blood||
0457|022|W|pressure or diabetes). Do not take this drug right before or||
0457|023|W|after heart bypass surgery (CABG).||
0457|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0457|025|W|bleeding from the stomach or intestines. This effect can occur||
0457|026|W|without warning symptoms at any time while taking this drug.||
0457|027|W|Older adults may be at higher risk for this effect.||
0457|028|W|   Stop taking fenoprofen and get medical help right away if you||
0457|029|W|notice any of these rare but serious side effects:||
0457|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0457|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0457|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0457|033|W|side of the body, trouble speaking, sudden vision changes.||
0457|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0457|035|W|of taking this drug.||
0457|036|B|||
0457|037|U|USES:  See also Warning section.||
0457|038|U|   Fenoprofen is used to relieve pain from various conditions||
0457|039|U|such as headache, dental pain, menstrual cramps, and muscle||
0457|040|U|aches. Fenoprofen is also used to reduce pain, swelling, and||
0457|041|U|joint stiffness from arthritis.||
0457|042|U|   Fenoprofen is known as a nonsteroidal anti-inflammatory drug||
0457|043|U|(NSAID). It works by blocking your body's production of certain||
0457|044|U|natural substances that cause inflammation. This effect helps to||
0457|045|U|decrease swelling, pain, or fever.||
0457|046|U|   If you are treating a chronic condition such as arthritis, ask||
0457|047|U|your doctor about non-drug treatments and/or using other||
0457|048|U|medications to treat your pain.||
0457|049|B|||
0457|050|V|OTHER USES:  This section contains uses of this drug that are not||
0457|051|V|listed in the approved professional labeling for the drug but||
0457|052|V|that may be prescribed by your health care professional. Use this||
0457|053|V|drug for a condition that is listed in this section only if it||
0457|054|V|has been so prescribed by your health care professional.||
0457|055|V|   This medication may also be used for gout attacks.||
0457|056|B|||
0457|057|H|HOW TO USE:  Read the Medication Guide provided by your||
0457|058|H|pharmacist before you start taking fenoprofen and each time you||
0457|059|H|get a refill. If you have any questions, ask your doctor or||
0457|060|H|pharmacist.||
0457|061|H|   Take this medication by mouth as directed by your doctor,||
0457|062|H|usually 3 or 4 times a day or as needed. Take this medication||
0457|063|H|with a full glass of water (8 ounces or 240 milliliters) unless||
0457|064|H|your doctor directs you otherwise. Do not lie down for at least||
0457|065|H|10 minutes after taking this medication. If stomach upset occurs||
0457|066|H|while taking this medication, take it with food, milk, or an||
0457|067|H|antacid.||
0457|068|H|   The dosage is based on your medical condition and response to||
0457|069|H|treatment. To reduce your risk of stomach bleeding and other side||
0457|070|H|effects, take this medication at the lowest effective dose for||
0457|071|H|the shortest possible time. Do not increase your dose or use this||
0457|072|H|drug more often or for longer than prescribed. For ongoing||
0457|073|H|conditions such as arthritis, keep taking this medication as||
0457|074|H|directed. Discuss the risks and benefits with your doctor or||
0457|075|H|pharmacist.||
0457|076|H|   For certain conditions (such as arthritis), it may take up to||
0457|077|H|3 weeks of taking this drug regularly until you get the full||
0457|078|H|benefit.||
0457|079|H|   If you are taking this drug "as needed" (not on a regular||
0457|080|H|schedule), remember that pain medications work best if they are||
0457|081|H|used as the first signs of pain occur. If you wait until the pain||
0457|082|H|has worsened, the medicine may not work as well.||
0457|083|H|   Tell your doctor if your condition lasts or gets worse.||
0457|084|B|||
0457|085|S|SIDE EFFECTS:  See also Warning section.||
0457|086|S|   Upset stomach, constipation, nausea, drowsiness, dizziness, or||
0457|087|S|blurred vision may occur. If any of these effects last or get||
0457|088|S|worse, tell your doctor or pharmacist promptly.||
0457|089|S|   Remember that this medication has been prescribed because your||
0457|090|S|doctor has judged that the benefit to you is greater than the||
0457|091|S|risk of side effects. Many people using this medication do not||
0457|092|S|have serious side effects.||
0457|093|S|   This medication may raise your blood pressure. Check your||
0457|094|S|blood pressure regularly and tell your doctor if the results are||
0457|095|S|high.||
0457|096|S|   Tell your doctor right away if you have any serious side||
0457|097|S|effects, including: hearing changes (such as ringing in the||
0457|098|S|ears), mental/mood changes, easy bleeding/bruising,||
0457|099|S|difficult/painful swallowing, fast/pounding heartbeat, signs of||
0457|100|S|kidney problems (such as change in the amount of urine,||
0457|101|S|pink/bloody urine), symptoms of heart failure (such as swelling||
0457|102|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
0457|103|S|   Fenoprofen may rarely cause serious (possibly fatal) liver||
0457|104|S|disease. Get medical help right away if you have any symptoms of||
0457|105|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0457|106|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0457|107|S|urine.||
0457|108|S|   A very serious allergic reaction to this drug is rare.||
0457|109|S|However, get medical help right away if you notice any symptoms||
0457|110|S|of a serious allergic reaction, including: fever, swollen lymph||
0457|111|S|nodes, rash, itching/swelling (especially of the||
0457|112|S|face/tongue/throat), severe dizziness, trouble breathing.||
0457|113|S|   This is not a complete list of possible side effects. If you||
0457|114|S|notice other effects not listed above, contact your doctor or||
0457|115|S|pharmacist.||
0457|116|S|   In the US -||
0457|117|S|   Call your doctor for medical advice about side effects. You||
0457|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0457|119|S|www.fda.gov/medwatch.||
0457|120|S|   In Canada - Call your doctor for medical advice about side||
0457|121|S|effects. You may report side effects to Health Canada at||
0457|122|S|1-866-234-2345.||
0457|123|B|||
0457|124|P|PRECAUTIONS:  See also Warning section.||
0457|125|P|   Before taking fenoprofen, tell your doctor or pharmacist if||
0457|126|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
0457|127|P|ibuprofen, naproxen, celecoxib); or if you have any other||
0457|128|P|allergies. This product may contain inactive ingredients, which||
0457|129|P|can cause allergic reactions or other problems. Talk to your||
0457|130|P|pharmacist for more details.||
0457|131|P|   Before using this medication, tell your doctor or pharmacist||
0457|132|P|your medical history, especially of: asthma (including a history||
0457|133|P|of worsening breathing after taking aspirin or other NSAIDs),||
0457|134|P|bleeding/clotting problems, blood disorders (such as anemia),||
0457|135|P|diabetes, growths in the nose (nasal polyps), heart disease (such||
0457|136|P|as previous heart attack), high blood pressure, liver disease,||
0457|137|P|stroke, swelling (edema, fluid retention),||
0457|138|P|stomach/intestine/esophagus problems (such as bleeding,||
0457|139|P|heartburn, ulcers).||
0457|140|P|   Kidney problems can sometimes occur with the use of NSAID||
0457|141|P|medications, including fenoprofen. Problems are more likely to||
0457|142|P|occur if you are dehydrated, have heart failure or kidney||
0457|143|P|disease, are an older adult, or if you take certain medications||
0457|144|P|(see also Drug Interactions section). Drink plenty of fluids as||
0457|145|P|directed by your doctor to prevent dehydration and tell your||
0457|146|P|doctor right away if you have pink/bloody urine or any unusual||
0457|147|P|change in the amount of urine.||
0457|148|P|   This drug may make you dizzy or drowsy or cause blurred||
0457|149|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
0457|150|P|Do not drive, use machinery, or do anything that needs alertness||
0457|151|P|or clear vision until you can do it safely. Limit alcoholic||
0457|152|P|beverages. Talk to your doctor if you are using marijuana||
0457|153|P|(cannabis).||
0457|154|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0457|155|P|and tobacco, especially when combined with this medicine, may||
0457|156|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0457|157|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
0457|158|P|may safely drink.||
0457|159|P|   This medication may make you more sensitive to the sun. Limit||
0457|160|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0457|161|P|sunscreen and wear protective clothing when outdoors. Tell your||
0457|162|P|doctor right away if you get sunburned or have skin||
0457|163|P|blisters/redness.||
0457|164|P|   Before having surgery, tell your doctor or dentist about all||
0457|165|P|the products you use (including prescription drugs,||
0457|166|P|nonprescription drugs, and herbal products).||
0457|167|P|   Older adults may be at greater risk for stomach/intestinal||
0457|168|P|bleeding, kidney problems, heart attack, and stroke while using||
0457|169|P|this drug.||
0457|170|P|   Before using this medication, women of childbearing age should||
0457|171|P|talk with their doctor(s) about the benefits and risks. Tell your||
0457|172|P|doctor if you are pregnant or if you plan to become pregnant.||
0457|173|P|This medication may harm an unborn baby and cause problems with||
0457|174|P|normal labor/delivery. It is not recommended for use in pregnancy||
0457|175|P|from 20 weeks until delivery. If your doctor decides that you||
0457|176|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0457|177|P|you should use the lowest effective dose for the shortest||
0457|178|P|possible time. You should not use this medication after 30 weeks||
0457|179|P|of pregnancy.||
0457|180|P|   This medication passes into breast milk. Consult your doctor||
0457|181|P|before breastfeeding.||
0457|182|B|||
0457|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0457|184|I|medications work or increase your risk for serious side effects.||
0457|185|I|This document does not contain all possible drug interactions.||
0457|186|I|Keep a list of all the products you use (including||
0457|187|I|prescription/nonprescription drugs and herbal products) and share||
0457|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
0457|189|I|the dosage of any medicines without your doctor's approval.||
0457|190|I|   Some products that may interact with this drug are: aliskiren,||
0457|191|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
0457|192|I|receptor blockers (such as losartan, valsartan), cidofovir,||
0457|193|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
0457|194|I|methotrexate, "water pills" (diuretics such as furosemide).||
0457|195|I|   This medication may increase the risk of bleeding when taken||
0457|196|I|with other drugs that also may cause bleeding. Examples include||
0457|197|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0457|198|I|dabigatran/enoxaparin/warfarin, among others.||
0457|199|I|   Check all prescription and nonprescription medicine labels||
0457|200|I|carefully since many medications contain pain relievers/fever||
0457|201|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
0457|202|I|naproxen). These drugs are similar to fenoprofen and may increase||
0457|203|I|your risk of side effects if taken together. However, if your||
0457|204|I|doctor has told you to take low-dose aspirin to prevent heart||
0457|205|I|attack or stroke (usually 81-162 milligrams a day), you should||
0457|206|I|keep taking the aspirin unless your doctor tells you not to. Ask||
0457|207|I|your doctor or pharmacist for more details.||
0457|208|I|   This medication may interfere with certain lab tests (such as||
0457|209|I|thyroid hormone tests), possibly causing false test results. Make||
0457|210|I|sure lab personnel and all your doctors know you use this drug.||
0457|211|B|||
0457|212|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0457|213|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0457|214|O|poison control center right away. US residents can call||
0457|215|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0457|216|O|Symptoms of overdose may include: severe stomach pain,||
0457|217|O|slow/shallow breathing, extreme drowsiness, loss of||
0457|218|O|consciousness.||
0457|219|B|||
0457|220|N|NOTES:  Do not share this medication with others.||
0457|221|N|   Lab and/or medical tests (such as complete blood count, liver||
0457|222|N|and kidney function, blood pressure) may be done while you are||
0457|223|N|using this medication. Keep all medical and lab appointments.||
0457|224|N|Consult your doctor for more details.||
0457|225|N|   Lifestyle changes (such as weight loss if needed,||
0457|226|N|strengthening/conditioning exercises) may help improve your||
0457|227|N|flexibility and joint function. Consult your doctor for specific||
0457|228|N|instructions.||
0457|229|B|||
0457|230|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
0457|231|D|(not just "as needed") and you miss a dose, take it as soon as||
0457|232|D|you remember. If it is near the time of the next dose, skip the||
0457|233|D|missed dose. Take your next dose at the regular time. Do not||
0457|234|D|double the dose to catch up.||
0457|235|B|||
0457|236|R|STORAGE:  Store at room temperature away from light and moisture.||
0457|237|R|Do not store in the bathroom. Keep all medications away from||
0457|238|R|children and pets.||
0457|239|R|   Do not flush medications down the toilet or pour them into a||
0457|240|R|drain unless instructed to do so. Properly discard this product||
0457|241|R|when it is expired or no longer needed. Consult your pharmacist||
0457|242|R|or local waste disposal company.||
0457|243|B|||
0457|244|A|Information last revised November 2025.||
0457|245|A|Copyright(c) 2025 First Databank, Inc.||
0457|246|B|||
0458|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0458|002|Z|does NOT have all possible information about this product. This||
0458|003|Z|information does not assure that this product is safe, effective,||
0458|004|Z|or appropriate for you. This information is not individual||
0458|005|Z|medical advice and does not substitute for the advice of your||
0458|006|Z|health care professional. Always ask your health care||
0458|007|Z|professional for complete information about this product and your||
0458|008|Z|specific health needs.||
0458|009|B|||
0458|010|T|OXAPROZIN - ORAL||
0458|011|F|(OX-a-PROE-zin)||
0458|012|B|||
0458|013|C|COMMON BRAND NAME(S): Coxanto, Daypro||
0458|014|B|||
0458|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0458|016|W|oxaprozin) may rarely increase the risk of a heart attack or||
0458|017|W|stroke. This effect can happen at any time while taking this drug||
0458|018|W|but is more likely if you take it for a long time. The risk may||
0458|019|W|be greater in older adults or if you have heart disease or||
0458|020|W|increased risk for heart disease (for example, due to smoking,||
0458|021|W|family history of heart disease, or conditions such as high blood||
0458|022|W|pressure or diabetes). Do not take this drug right before or||
0458|023|W|after heart bypass surgery (CABG).||
0458|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0458|025|W|bleeding from the stomach or intestines. This effect can occur||
0458|026|W|without warning symptoms at any time while taking this drug.||
0458|027|W|Older adults may be at higher risk for this effect. (See also||
0458|028|W|Precautions and Drug Interactions sections.)||
0458|029|W|   Stop taking oxaprozin and get medical help right away if you||
0458|030|W|notice any of the following rare but serious side effects:||
0458|031|W|stomach/abdominal pain that doesn't go away, bloody or||
0458|032|W|black/tarry stools, vomit that looks like coffee grounds,||
0458|033|W|chest/jaw/left arm pain, shortness of breath, unusual sweating,||
0458|034|W|weakness on one side of the body, sudden vision changes, trouble||
0458|035|W|speaking.||
0458|036|W|   Talk with your doctor or pharmacist about the risks and||
0458|037|W|benefits of treatment with this medication.||
0458|038|B|||
0458|039|U|USES:  Oxaprozin is used to treat arthritis. It reduces pain,||
0458|040|U|swelling, and stiffness of the joints. Oxaprozin is known as a||
0458|041|U|nonsteroidal anti-inflammatory drug (NSAID).||
0458|042|U|   If you are treating a chronic condition such as arthritis, ask||
0458|043|U|your doctor about non-drug treatments and/or using other||
0458|044|U|medications to treat your pain. See also Warning section.||
0458|045|B|||
0458|046|V|OTHER USES:  This section contains uses of this drug that are not||
0458|047|V|listed in the approved professional labeling for the drug but||
0458|048|V|that may be prescribed by your health care professional. Use this||
0458|049|V|drug for a condition that is listed in this section only if it||
0458|050|V|has been so prescribed by your health care professional.||
0458|051|V|   This drug may also be used for gout attacks.||
0458|052|B|||
0458|053|H|HOW TO USE:  Read the Medication Guide provided by your||
0458|054|H|pharmacist before you start taking oxaprozin and each time you||
0458|055|H|get a refill. If you have any questions, ask your doctor or||
0458|056|H|pharmacist.||
0458|057|H|   Take this medication by mouth as directed by your doctor,||
0458|058|H|usually once daily. Drink a full glass of water (8 ounces/240||
0458|059|H|milliliters) with it unless your doctor directs you otherwise. Do||
0458|060|H|not lie down for at least 10 minutes after taking this drug. If||
0458|061|H|stomach upset occurs while taking this medication, take it with||
0458|062|H|food, milk, or an antacid.||
0458|063|H|   The dosage is based on your medical condition, body weight,||
0458|064|H|and response to treatment. To minimize side effect risks (such as||
0458|065|H|stomach bleeding), use this medication at the lowest effective||
0458|066|H|dose for the shortest possible length of time. Do not increase||
0458|067|H|your dose or take this drug more often than directed. For chronic||
0458|068|H|conditions such as arthritis, keep taking it as directed by your||
0458|069|H|doctor. Discuss the risks and benefits with your doctor or||
0458|070|H|pharmacist.||
0458|071|H|   Oxaprozin may come in different forms (such as tablet,||
0458|072|H|capsule). Do not switch between different forms without||
0458|073|H|consulting your doctor.||
0458|074|H|   In certain conditions (such as arthritis), it may take up to 2||
0458|075|H|weeks when this drug is taken regularly before you notice the||
0458|076|H|full benefits.||
0458|077|H|   Tell your doctor if your condition gets worse.||
0458|078|B|||
0458|079|S|SIDE EFFECTS:  See also Warning section.||
0458|080|S|   Upset stomach, constipation, diarrhea, nausea, vomiting, gas,||
0458|081|S|heartburn, drowsiness, dizziness, or headache may occur. If any||
0458|082|S|of these effects last or get worse, tell your doctor or||
0458|083|S|pharmacist promptly.||
0458|084|S|   Remember that this medication has been prescribed because your||
0458|085|S|doctor has judged that the benefit to you is greater than the||
0458|086|S|risk of side effects. Many people using this medication do not||
0458|087|S|have serious side effects.||
0458|088|S|   This medication may raise your blood pressure. Check your||
0458|089|S|blood pressure regularly and tell your doctor if the results are||
0458|090|S|high.||
0458|091|S|   Tell your doctor right away if you have any serious side||
0458|092|S|effects, including: vision changes, hearing changes (such as||
0458|093|S|ringing in the ears), mental/mood changes, signs of kidney||
0458|094|S|problems (such as change in the amount of urine), easy||
0458|095|S|bruising/bleeding, symptoms of heart failure (such as swelling||
0458|096|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
0458|097|S|   This drug may rarely cause serious (possibly fatal) liver||
0458|098|S|disease. Get medical help right away if you have any symptoms of||
0458|099|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0458|100|S|of appetite, dark urine, severe stomach/abdominal pain, yellowing||
0458|101|S|eyes/skin.||
0458|102|S|   A very serious allergic reaction to this drug is rare.||
0458|103|S|However, get medical help right away if you notice any symptoms||
0458|104|S|of a serious allergic reaction, including: fever, swollen lymph||
0458|105|S|nodes, rash, itching/swelling (especially of the||
0458|106|S|face/tongue/throat), severe dizziness, trouble breathing.||
0458|107|S|   This is not a complete list of possible side effects. If you||
0458|108|S|notice other effects not listed above, contact your doctor or||
0458|109|S|pharmacist.||
0458|110|S|   In the US -||
0458|111|S|   Call your doctor for medical advice about side effects. You||
0458|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0458|113|S|www.fda.gov/medwatch.||
0458|114|S|   In Canada - Call your doctor for medical advice about side||
0458|115|S|effects. You may report side effects to Health Canada at||
0458|116|S|1-866-234-2345.||
0458|117|B|||
0458|118|P|PRECAUTIONS:  Before taking oxaprozin, tell your doctor or||
0458|119|P|pharmacist if you are allergic to it; or to aspirin or other||
0458|120|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
0458|121|P|any other allergies. This product may contain inactive||
0458|122|P|ingredients, which can cause allergic reactions or other||
0458|123|P|problems. Talk to your pharmacist for more details.||
0458|124|P|   Before using this medication, tell your doctor or pharmacist||
0458|125|P|your medical history, especially of: asthma (including a history||
0458|126|P|of worsening breathing after taking aspirin or other NSAIDs),||
0458|127|P|liver disease, stomach/intestine/esophagus problems (such as||
0458|128|P|bleeding, ulcers, recurring heartburn), heart disease (such as||
0458|129|P|history of heart attack), high blood pressure, stroke, blood||
0458|130|P|disorders (such as anemia, bleeding/clotting problems), growths||
0458|131|P|in the nose (nasal polyps).||
0458|132|P|   Kidney problems can sometimes occur with the use of NSAID||
0458|133|P|medications, including oxaprozin. Problems are more likely to||
0458|134|P|occur if you are dehydrated, have heart failure or kidney||
0458|135|P|disease, are an older adult, or if you take certain medications||
0458|136|P|(see also Drug Interactions section). Drink plenty of fluids as||
0458|137|P|directed by your doctor to prevent dehydration and tell your||
0458|138|P|doctor right away if you have a change in the amount of urine.||
0458|139|P|   Before having surgery, tell your doctor or dentist about all||
0458|140|P|the products you use (including prescription drugs,||
0458|141|P|nonprescription drugs, and herbal products).||
0458|142|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0458|143|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0458|144|P|machinery, or do anything that needs alertness until you can do||
0458|145|P|it safely. Talk to your doctor if you are using marijuana||
0458|146|P|(cannabis).||
0458|147|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0458|148|P|and tobacco, especially when combined with this medicine, may||
0458|149|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0458|150|P|smoking. Consult your doctor or pharmacist for more information.||
0458|151|P|   This medication may make you more sensitive to the sun. Limit||
0458|152|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0458|153|P|sunscreen and wear protective clothing when outdoors. Tell your||
0458|154|P|doctor right away if you get sunburned or have skin||
0458|155|P|blisters/redness.||
0458|156|P|   Older adults may be at greater risk for stomach/intestinal||
0458|157|P|bleeding, kidney problems, heart attack, and stroke while using||
0458|158|P|this drug.||
0458|159|P|   Before using this medication, women of childbearing age should||
0458|160|P|talk with their doctor(s) about the benefits and risks. Tell your||
0458|161|P|doctor if you are pregnant or if you plan to become pregnant.||
0458|162|P|This medication may harm an unborn baby and cause problems with||
0458|163|P|normal labor/delivery. It is not recommended for use in pregnancy||
0458|164|P|from 20 weeks until delivery. If your doctor decides that you||
0458|165|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0458|166|P|you should use the lowest effective dose for the shortest||
0458|167|P|possible time. You should not use this medication after 30 weeks||
0458|168|P|of pregnancy.||
0458|169|P|   It is unknown if this drug passes into breast milk. Consult||
0458|170|P|your doctor before breastfeeding.||
0458|171|B|||
0458|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0458|173|I|medications work or increase your risk for serious side effects.||
0458|174|I|This document does not contain all possible drug interactions.||
0458|175|I|Keep a list of all the products you use (including||
0458|176|I|prescription/nonprescription drugs and herbal products) and share||
0458|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
0458|178|I|the dosage of any medicines without your doctor's approval.||
0458|179|I|   Some products that may interact with this drug include:||
0458|180|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
0458|181|I|angiotensin II receptor blockers (such as losartan, valsartan),||
0458|182|I|cidofovir, lithium, methotrexate, "water pills" (diuretics such||
0458|183|I|as furosemide).||
0458|184|I|   This medication may increase the risk of bleeding when taken||
0458|185|I|with other drugs that also may cause bleeding. Examples include||
0458|186|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0458|187|I|dabigatran/enoxaparin/warfarin, among others.||
0458|188|I|   Check all prescription and nonprescription medicine labels||
0458|189|I|carefully since many medications contain pain relievers/fever||
0458|190|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen,||
0458|191|I|ketorolac). These drugs are similar to oxaprozin and may increase||
0458|192|I|your risk of side effects if taken together. However, if your||
0458|193|I|doctor has told you to take low-dose aspirin to prevent heart||
0458|194|I|attack or stroke (usually 81-162 milligrams a day), you should||
0458|195|I|keep taking the aspirin unless your doctor tells you not to. Ask||
0458|196|I|your doctor or pharmacist for more details.||
0458|197|I|   This medication may interfere with certain lab tests, possibly||
0458|198|I|causing false test results. Make sure lab personnel and all your||
0458|199|I|doctors know you use this drug.||
0458|200|B|||
0458|201|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0458|202|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0458|203|O|poison control center right away. US residents can call||
0458|204|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0458|205|O|Symptoms of overdose may include: severe stomach pain, vomit that||
0458|206|O|looks like coffee grounds, extreme drowsiness, loss of||
0458|207|O|consciousness, slowed or shallow breathing.||
0458|208|B|||
0458|209|N|NOTES:  Do not share this medication with others.||
0458|210|N|   Lab and/or medical tests (such as blood pressure, complete||
0458|211|N|blood count, kidney/liver function) may be done while you are||
0458|212|N|taking this medication. Keep all medical and lab appointments.||
0458|213|N|Consult your doctor for more details.||
0458|214|N|   Non-drug treatment for arthritis that is approved by your||
0458|215|N|doctor (such as weight loss if needed, strengthening and||
0458|216|N|conditioning exercises) may help improve your flexibility, range||
0458|217|N|of motion, and joint function. Consult your doctor for more||
0458|218|N|information.||
0458|219|B|||
0458|220|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0458|221|D|remember. If it is near the time of the next dose, skip the||
0458|222|D|missed dose. Take your next dose at the regular time. Do not||
0458|223|D|double the dose to catch up.||
0458|224|B|||
0458|225|R|STORAGE:  Store at room temperature away from light and moisture.||
0458|226|R|Do not store in the bathroom. Keep all medications away from||
0458|227|R|children and pets.||
0458|228|R|   Do not flush medications down the toilet or pour them into a||
0458|229|R|drain unless instructed to do so. Properly discard this product||
0458|230|R|when it is expired or no longer needed. Consult your pharmacist||
0458|231|R|or local waste disposal company.||
0458|232|B|||
0458|233|A|Information last revised November 2024.||
0458|234|A|Copyright(c) 2025 First Databank, Inc.||
0458|235|B|||
0459|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0459|002|Z|does NOT have all possible information about this product. This||
0459|003|Z|information does not assure that this product is safe, effective,||
0459|004|Z|or appropriate for you. This information is not individual||
0459|005|Z|medical advice and does not substitute for the advice of your||
0459|006|Z|health care professional. Always ask your health care||
0459|007|Z|professional for complete information about this product and your||
0459|008|Z|specific health needs.||
0459|009|B|||
0459|010|T|NADOLOL - ORAL||
0459|011|F|(NAY-doe-lol)||
0459|012|B|||
0459|013|C|COMMON BRAND NAME(S): Corgard||
0459|014|B|||
0459|015|W|WARNING:  If you have chest pain (angina) or heart disease (such||
0459|016|W|as coronary artery disease, ischemic heart disease, high blood||
0459|017|W|pressure), do not stop using this drug without first consulting||
0459|018|W|your doctor. Your condition may become worse when the drug is||
0459|019|W|suddenly stopped. If your doctor decides you should no longer use||
0459|020|W|this drug, you must gradually decrease your dose according to||
0459|021|W|your doctor's instructions.||
0459|022|W|   When gradually stopping this medication, it is recommended||
0459|023|W|that you temporarily limit physical activity to decrease work for||
0459|024|W|the heart. Get medical help right away if you develop worsening||
0459|025|W|chest pain, tightness/pressure in the chest, chest pain spreading||
0459|026|W|to the jaw/neck/arm, sweating, trouble breathing, or||
0459|027|W|fast/irregular heartbeat.||
0459|028|B|||
0459|029|U|USES:  Nadolol is used alone or with other medications to treat||
0459|030|U|high blood pressure (hypertension) and to prevent chest pain||
0459|031|U|(angina). Lowering high blood pressure helps prevent strokes,||
0459|032|U|heart attacks, and kidney problems. In the management of chest||
0459|033|U|pain, nadolol may also help to reduce the frequency of chest pain||
0459|034|U|episodes and improve your ability to exercise.||
0459|035|U|   Nadolol belongs to a class of medications called beta||
0459|036|U|blockers. It works by blocking the action of certain natural||
0459|037|U|substances such as adrenaline (epinephrine) on the heart and||
0459|038|U|blood vessels. This results in a lowering of heart rate, blood||
0459|039|U|pressure, and strain on the heart.||
0459|040|B|||
0459|041|V|OTHER USES:  This section contains uses of this drug that are not||
0459|042|V|listed in the approved professional labeling for the drug but||
0459|043|V|that may be prescribed by your health care professional. Use this||
0459|044|V|drug for a condition that is listed in this section only if it||
0459|045|V|has been so prescribed by your health care professional.||
0459|046|V|   This drug may also be used to protect the heart after a heart||
0459|047|V|attack. It may also be used for irregular heartbeat (such as||
0459|048|V|atrial fibrillation, atrial flutter), or used to reduce the risk||
0459|049|V|of migraine headaches.||
0459|050|B|||
0459|051|H|HOW TO USE:  See also the Warning section.||
0459|052|H|   Take this medication by mouth with or without food as directed||
0459|053|H|by your doctor, usually once daily. The dosage is based on your||
0459|054|H|medical condition and response to treatment.||
0459|055|H|   Use this medication regularly in order to get the most benefit||
0459|056|H|from it. To help you remember, take it at the same time each day.||
0459|057|H|This medication treats, but does not cure, high blood pressure.||
0459|058|H|Keep taking this medication even if you feel well. Most people||
0459|059|H|with high blood pressure do not feel sick.||
0459|060|H|   Do not stop taking this medication without consulting your||
0459|061|H|doctor. Your condition may become worse when the drug is suddenly||
0459|062|H|stopped. Your dose may need to be gradually decreased.||
0459|063|H|   Tell your doctor if your condition does not get better or if||
0459|064|H|it gets worse (for example, your blood pressure readings remain||
0459|065|H|high or increase).||
0459|066|B|||
0459|067|S|SIDE EFFECTS:  Dizziness, drowsiness, weakness, and cough may||
0459|068|S|occur. If any of these effects last or get worse, tell your||
0459|069|S|doctor or pharmacist promptly.||
0459|070|S|   To reduce the risk of dizziness and lightheadedness, get up||
0459|071|S|slowly when rising from a sitting or lying position.||
0459|072|S|   This drug may reduce blood flow to your hands and feet,||
0459|073|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0459|074|S|warmly and avoid tobacco use.||
0459|075|S|   Remember that this medication has been prescribed because your||
0459|076|S|doctor has judged that the benefit to you is greater than the||
0459|077|S|risk of side effects. Many people using this medication do not||
0459|078|S|have serious side effects.||
0459|079|S|   Tell your doctor right away if you have any serious side||
0459|080|S|effects, including: bluish color of the fingers/toes/nails, hair||
0459|081|S|loss (reversible), mental/mood changes (such as depression,||
0459|082|S|confusion, memory problems), numbness/tingling, decreased sexual||
0459|083|S|ability, vision changes, wheezing, fainting, slow/irregular/fast||
0459|084|S|heartbeat, new or worsening symptoms of heart failure (such as||
0459|085|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
0459|086|S|unusual/sudden weight gain).||
0459|087|S|   A very serious allergic reaction to this drug is rare.||
0459|088|S|However, get medical help right away if you notice any symptoms||
0459|089|S|of a serious allergic reaction, including: rash, itching/swelling||
0459|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0459|091|S|breathing.||
0459|092|S|   This is not a complete list of possible side effects. If you||
0459|093|S|notice other effects not listed above, contact your doctor or||
0459|094|S|pharmacist.||
0459|095|S|   In the US -||
0459|096|S|   Call your doctor for medical advice about side effects. You||
0459|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0459|098|S|www.fda.gov/medwatch.||
0459|099|S|   In Canada - Call your doctor for medical advice about side||
0459|100|S|effects. You may report side effects to Health Canada at||
0459|101|S|1-866-234-2345.||
0459|102|B|||
0459|103|P|PRECAUTIONS:  Before taking nadolol, tell your doctor or||
0459|104|P|pharmacist if you are allergic to it; or to other beta blockers||
0459|105|P|(such as atenolol, propranolol); or if you have any other||
0459|106|P|allergies. This product may contain inactive ingredients, which||
0459|107|P|can cause allergic reactions or other problems. Talk to your||
0459|108|P|pharmacist for more details.||
0459|109|P|   Before using this medication, tell your doctor or pharmacist||
0459|110|P|your medical history, especially of: certain types of heart||
0459|111|P|rhythm problems (such as a slow heartbeat, second- or||
0459|112|P|third-degree atrioventricular block), blood circulation problems||
0459|113|P|(such as Raynaud's disease, peripheral vascular disease),||
0459|114|P|breathing problems (such as asthma, chronic bronchitis,||
0459|115|P|emphysema), heart failure, kidney disease, mental/mood disorders||
0459|116|P|(such as depression), a certain muscle disease (myasthenia||
0459|117|P|gravis), skin conditions (such as atopy, psoriasis), overactive||
0459|118|P|thyroid disease (hyperthyroidism), a certain adrenal gland tumor||
0459|119|P|(pheochromocytoma).||
0459|120|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0459|121|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0459|122|P|machinery, or do anything that needs alertness until you can do||
0459|123|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0459|124|P|are using marijuana (cannabis).||
0459|125|P|   Before having surgery, tell your doctor or dentist about all||
0459|126|P|the products you use (including prescription drugs,||
0459|127|P|nonprescription drugs, and herbal products).||
0459|128|P|   This product may prevent the fast/pounding heartbeat you would||
0459|129|P|usually feel when your blood sugar level falls too low||
0459|130|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0459|131|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0459|132|P|blood sugar level, such as dizziness and sweating, are not||
0459|133|P|affected by this drug.||
0459|134|P|   If you have diabetes, this product may make it harder to||
0459|135|P|control your blood sugar levels. Check your blood sugar levels||
0459|136|P|regularly as directed by your doctor. Tell your doctor right away||
0459|137|P|if you have symptoms of high blood sugar such as increased||
0459|138|P|thirst/urination. Your doctor may need to adjust your diabetes||
0459|139|P|medication, exercise program, or diet.||
0459|140|P|   Children may be at greater risk for low blood sugar||
0459|141|P|(hypoglycemia) while using this drug, especially if they are||
0459|142|P|vomiting or not eating regularly. To help prevent low blood||
0459|143|P|sugar, make sure children eat regularly. If your child cannot eat||
0459|144|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
0459|145|P|as sweating, shaking), tell the doctor right away.||
0459|146|P|   Older adults may be at a greater risk for side effects such as||
0459|147|P|dizziness while using this drug.||
0459|148|P|   During pregnancy, this medication should be used only when||
0459|149|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0459|150|P|benefits with your doctor.||
0459|151|P|   This medication passes into breast milk and may have||
0459|152|P|undesirable effects on a nursing infant. Consult your doctor||
0459|153|P|before breastfeeding.||
0459|154|B|||
0459|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0459|156|I|medications work or increase your risk for serious side effects.||
0459|157|I|This document does not contain all possible drug interactions.||
0459|158|I|Keep a list of all the products you use (including||
0459|159|I|prescription/nonprescription drugs and herbal products) and share||
0459|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
0459|161|I|the dosage of any medicines without your doctor's approval.||
0459|162|I|   Some products that may interact with this drug include:||
0459|163|I|epinephrine, fingolimod.||
0459|164|I|   Tell your doctor or pharmacist if you are taking other||
0459|165|I|products that cause drowsiness such as opioid pain or cough||
0459|166|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0459|167|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0459|168|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0459|169|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0459|170|I|diphenhydramine).||
0459|171|I|   Check the labels on all your medicines (such as allergy or||
0459|172|I|cough-and-cold products) because they may contain ingredients||
0459|173|I|that cause drowsiness. Ask your pharmacist about using those||
0459|174|I|products safely.||
0459|175|I|   Some products have ingredients that could raise your heart||
0459|176|I|rate or blood pressure. Tell your pharmacist what products you||
0459|177|I|are using, and ask how to use them safely (especially||
0459|178|I|cough-and-cold products, diet aids, or NSAIDs such as||
0459|179|I|ibuprofen/naproxen).||
0459|180|B|||
0459|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0459|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0459|183|O|poison control center right away. US residents can call||
0459|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0459|185|O|Symptoms of overdose may include: very slow heartbeat, severe||
0459|186|O|dizziness/fainting, loss of consciousness, severe weakness,||
0459|187|O|shortness of breath.||
0459|188|B|||
0459|189|N|NOTES:  Do not share this medication with others.||
0459|190|N|   Lifestyle changes such as stress reduction programs, exercise,||
0459|191|N|and dietary changes may increase the effectiveness of this||
0459|192|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0459|193|N|changes that might benefit you.||
0459|194|N|   Lab and/or medical tests (such as blood pressure, kidney||
0459|195|N|function) should be done while you are taking this medication.||
0459|196|N|Keep all medical and lab appointments. Consult your doctor for||
0459|197|N|more details.||
0459|198|N|   Have your blood pressure and pulse checked regularly while||
0459|199|N|taking this medication. It may be best to learn how to monitor||
0459|200|N|your own blood pressure and pulse.||
0459|201|B|||
0459|202|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0459|203|D|remember. If it is near the time of the next dose, skip the||
0459|204|D|missed dose. Take your next dose at the regular time. Do not||
0459|205|D|double the dose to catch up.||
0459|206|B|||
0459|207|R|STORAGE:  Store at room temperature away from light and moisture.||
0459|208|R|Do not store in the bathroom. Keep all medications away from||
0459|209|R|children and pets.||
0459|210|R|   Do not flush medications down the toilet or pour them into a||
0459|211|R|drain unless instructed to do so. Properly discard this product||
0459|212|R|when it is expired or no longer needed. Consult your pharmacist||
0459|213|R|or local waste disposal company.||
0459|214|B|||
0459|215|M|MEDICAL ALERT:  Your condition can cause complications in a||
0459|216|M|medical emergency. For information about enrolling in MedicAlert,||
0459|217|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0459|218|B|||
0459|219|A|Information last revised August 2024.||
0459|220|A|Copyright(c) 2025 First Databank, Inc.||
0459|221|B|||
0460|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0460|002|Z|does NOT have all possible information about this product. This||
0460|003|Z|information does not assure that this product is safe, effective,||
0460|004|Z|or appropriate for you. This information is not individual||
0460|005|Z|medical advice and does not substitute for the advice of your||
0460|006|Z|health care professional. Always ask your health care||
0460|007|Z|professional for complete information about this product and your||
0460|008|Z|specific health needs.||
0460|009|B|||
0460|010|T|FLUTICASONE HFA INHALER - ORAL INHALATION||
0460|011|F|(floo-TIK-a-sone)||
0460|012|B|||
0460|013|C|COMMON BRAND NAME(S): Flovent HFA||
0460|014|B|||
0460|015|U|USES:  Fluticasone is used to control and prevent symptoms (such||
0460|016|U|as wheezing and shortness of breath) caused by asthma. It works||
0460|017|U|by reducing swelling (inflammation) of the airways in the lungs||
0460|018|U|to make breathing easier. Controlling symptoms of asthma helps||
0460|019|U|you maintain your normal activities and decreases time lost from||
0460|020|U|work or school. Fluticasone belongs to a class of drugs known as||
0460|021|U|corticosteroids.||
0460|022|U|   This medication must be used regularly to be effective. It||
0460|023|U|does not work right away and should not be used to relieve sudden||
0460|024|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
0460|025|U|inhaler (such as albuterol, also called salbutamol in some||
0460|026|U|countries) as prescribed.||
0460|027|B|||
0460|028|V|OTHER USES:  This section contains uses of this drug that are not||
0460|029|V|listed in the approved professional labeling for the drug but||
0460|030|V|that may be prescribed by your health care professional. Use this||
0460|031|V|drug for a condition that is listed in this section only if it||
0460|032|V|has been so prescribed by your health care professional.||
0460|033|V|   Fluticasone may also be used with other medications to control||
0460|034|V|symptoms of ongoing lung disease (such as chronic bronchitis,||
0460|035|V|emphysema, COPD). It may also be used for a certain esophagus||
0460|036|V|problem (eosinophilic esophagitis).||
0460|037|B|||
0460|038|H|HOW TO USE:  Read the Patient Information Leaflet and||
0460|039|H|Instructions for Use provided by your pharmacist before you start||
0460|040|H|using this medication and each time you get a refill. Follow the||
0460|041|H|illustrated directions for the proper use of this medication. If||
0460|042|H|you have any questions, ask your doctor or pharmacist.||
0460|043|H|   Follow the instructions for priming the inhaler if you are||
0460|044|H|using it for the first time, if you have not used it for more||
0460|045|H|than 1 week, or if you dropped the inhaler. When priming the||
0460|046|H|inhaler, make sure to spray away from your face so that you do||
0460|047|H|not get the medication into your eyes.||
0460|048|H|   Shake the inhaler well for 5 seconds before each use. Inhale||
0460|049|H|this medication by mouth as directed by your doctor, usually||
0460|050|H|twice a day (in the morning and evening). The dosage is based on||
0460|051|H|your medical condition and response to treatment.||
0460|052|H|   Talk to your doctor or pharmacist if you have trouble using||
0460|053|H|this inhaler. Young children may get better results using a||
0460|054|H|spacer device and face mask with this medication.||
0460|055|H|   If two inhalations/puffs are prescribed, wait about 30 seconds||
0460|056|H|between them. Shake the inhaler well between each puff. If you||
0460|057|H|are using other inhalers at the same time, wait at least 1 minute||
0460|058|H|between the use of each medication, and use this drug (the||
0460|059|H|corticosteroid) last.||
0460|060|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
0460|061|H|from developing, gargle, rinse your mouth with water and spit out||
0460|062|H|after each use. Do not swallow the rinse water.||
0460|063|H|   Use this medication regularly to get the most benefit from it.||
0460|064|H|This medication works best if used at evenly spaced intervals. To||
0460|065|H|help you remember, use it at the same times each day. Do not||
0460|066|H|increase your dose, use this medication more often, or stop using||
0460|067|H|it without first consulting your doctor.||
0460|068|H|   If you are regularly taking a different corticosteroid by||
0460|069|H|mouth (such as prednisone), you should not stop taking it unless||
0460|070|H|directed by your doctor. Some conditions (such as asthma,||
0460|071|H|allergies) may become worse when the drug is suddenly stopped. If||
0460|072|H|you suddenly stop taking the drug, you may also have withdrawal||
0460|073|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
0460|074|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
0460|075|H|doctor may slowly lower the dose of your old medication after you||
0460|076|H|begin using fluticasone. Tell your doctor or pharmacist right||
0460|077|H|away if you have withdrawal. See also Precautions section.||
0460|078|H|   Clean the inhaler regularly as directed. Keep track of the||
0460|079|H|number of inhalations used. Discard the canister after using the||
0460|080|H|labeled number of inhalations on the package, even if it feels as||
0460|081|H|though there is medication left in the canister.||
0460|082|H|   It may take up to 2 weeks or longer before the full benefit of||
0460|083|H|this drug takes effect. Tell your doctor if your condition does||
0460|084|H|not get better or if it gets worse.||
0460|085|H|   Learn which of your inhalers you should use every day||
0460|086|H|(controller drugs) and which you should use if your breathing||
0460|087|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
0460|088|H|time what you should do if you have new or worsening cough or||
0460|089|H|shortness of breath, wheezing, increased sputum, worsening peak||
0460|090|H|flow meter readings, waking up at night with trouble breathing,||
0460|091|H|if you use your quick-relief inhaler more often (more than 2 days||
0460|092|H|a week), or if your quick-relief inhaler does not seem to be||
0460|093|H|working well. Learn when you can treat sudden breathing problems||
0460|094|H|by yourself and when you must get medical help right away.||
0460|095|B|||
0460|096|S|SIDE EFFECTS:  Hoarseness or throat irritation may occur. If||
0460|097|S|either of these effects lasts or gets worse, tell your doctor or||
0460|098|S|pharmacist promptly.||
0460|099|S|   Remember that this medication has been prescribed because your||
0460|100|S|doctor has judged that the benefit to you is greater than the||
0460|101|S|risk of side effects. Many people using this medication do not||
0460|102|S|have serious side effects.||
0460|103|S|   Tell your doctor right away if you have any serious side||
0460|104|S|effects, including: white patches in your mouth/on your tongue,||
0460|105|S|signs of infection (such as sore throat that doesn't go away,||
0460|106|S|fever, chills), vision problems, increased thirst/urination, easy||
0460|107|S|bruising/bleeding, mental/mood changes (such as depression, mood||
0460|108|S|swings, agitation), bone pain.||
0460|109|S|   Rarely, this medication may cause sudden severe||
0460|110|S|wheezing/trouble breathing immediately after you use it. If this||
0460|111|S|occurs, use your quick-relief inhaler and get medical help right||
0460|112|S|away.||
0460|113|S|   A very serious allergic reaction to this drug is rare.||
0460|114|S|However, get medical help right away if you notice any symptoms||
0460|115|S|of a serious allergic reaction, including: rash, itching/swelling||
0460|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0460|117|S|breathing.||
0460|118|S|   This is not a complete list of possible side effects. If you||
0460|119|S|notice other effects not listed above, contact your doctor or||
0460|120|S|pharmacist.||
0460|121|S|   In the US -||
0460|122|S|   Call your doctor for medical advice about side effects. You||
0460|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0460|124|S|www.fda.gov/medwatch.||
0460|125|S|   In Canada - Call your doctor for medical advice about side||
0460|126|S|effects. You may report side effects to Health Canada at||
0460|127|S|1-866-234-2345.||
0460|128|B|||
0460|129|P|PRECAUTIONS:  Before using fluticasone, tell your doctor or||
0460|130|P|pharmacist if you are allergic to it; or if you have any other||
0460|131|P|allergies. This product may contain inactive ingredients, which||
0460|132|P|can cause allergic reactions or other problems. Talk to your||
0460|133|P|pharmacist for more details.||
0460|134|P|   Before using this medication, tell your doctor or pharmacist||
0460|135|P|your medical history, especially of: current/past infections||
0460|136|P|(such as tuberculosis, herpes), certain eye problems (cataracts,||
0460|137|P|glaucoma, herpes infection of the eye), bone loss (osteoporosis),||
0460|138|P|liver disease.||
0460|139|P|   This medication may mask signs of infection. It can make you||
0460|140|P|more likely to get infections or may make current infections||
0460|141|P|worse. Stay away from anyone who has an infection that may easily||
0460|142|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0460|143|P|doctor if you have been exposed to an infection or for more||
0460|144|P|details.||
0460|145|P|   If you have switched from a corticosteroid taken by mouth||
0460|146|P|(such as prednisone tablets) to this inhaler within the past 12||
0460|147|P|months, or if you have been using this product in||
0460|148|P|higher-than-usual doses for a long time, it may be more difficult||
0460|149|P|for your body to respond to physical stress. Before having||
0460|150|P|surgery or emergency treatment, or if you get a serious||
0460|151|P|illness/injury, tell your doctor or dentist that you are using||
0460|152|P|this medication or have used a corticosteroid taken by mouth||
0460|153|P|within the past 12 months. Tell your doctor right away if you||
0460|154|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
0460|155|P|card or medical ID bracelet that says you use (or have used)||
0460|156|P|corticosteroid medications.||
0460|157|P|   Before having surgery, tell your doctor or dentist about all||
0460|158|P|the products you use (including prescription drugs,||
0460|159|P|nonprescription drugs, and herbal products).||
0460|160|P|   This medication may temporarily slow down a child's growth if||
0460|161|P|used for a long time. However, poorly controlled asthma can also||
0460|162|P|slow down growth. See the doctor regularly so your child's height||
0460|163|P|can be checked.||
0460|164|P|   During pregnancy, this medication should be used only when||
0460|165|P|clearly needed. Discuss the risks and benefits with your doctor.||
0460|166|P|   It is unknown if this drug passes into breast milk. Consult||
0460|167|P|your doctor before breastfeeding.||
0460|168|B|||
0460|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0460|170|I|medications work or increase your risk for serious side effects.||
0460|171|I|This document does not contain all possible drug interactions.||
0460|172|I|Keep a list of all the products you use (including||
0460|173|I|prescription/nonprescription drugs and herbal products) and share||
0460|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
0460|175|I|the dosage of any medicines without your doctor's approval.||
0460|176|I|   A product that may interact with this drug is: desmopressin.||
0460|177|I|   Other medications can affect the removal of fluticasone from||
0460|178|I|your body, which may affect how fluticasone works. Examples||
0460|179|I|include some azole antifungals (such as ketoconazole), HIV||
0460|180|I|protease inhibitors (such as lopinavir), ritonavir, among others.||
0460|181|B|||
0460|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0460|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0460|184|O|poison control center right away. US residents can call||
0460|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0460|186|B|||
0460|187|N|NOTES:  Do not share this medication with others.||
0460|188|N|   Lab and/or medical tests (such as lung function, eye exams,||
0460|189|N|bone density tests, cortisol levels) should be done while you are||
0460|190|N|using this medication. Keep all medical and lab appointments.||
0460|191|N|Consult your doctor for more details.||
0460|192|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
0460|193|N|mold that can worsen breathing problems. Because the flu virus||
0460|194|N|can also worsen breathing problems, ask your doctor or pharmacist||
0460|195|N|if you should have a flu shot every year.||
0460|196|N|   This medication may cause bone loss (osteoporosis) in adults||
0460|197|N|when used for a long time. Lifestyle changes that may help reduce||
0460|198|N|the risk of bone problems include doing weight-bearing exercise,||
0460|199|N|stopping smoking, limiting alcohol, and getting enough calcium||
0460|200|N|and vitamin D. Talk to your doctor for more details.||
0460|201|B|||
0460|202|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0460|203|D|If it is near the time of the next dose, skip the missed dose.||
0460|204|D|Use your next dose at the regular time. Do not double the dose to||
0460|205|D|catch up.||
0460|206|B|||
0460|207|R|STORAGE:  Store at room temperature. Do not puncture or expose||
0460|208|R|this medication to high heat or open flame. Keep all medications||
0460|209|R|away from children and pets.||
0460|210|R|   Do not flush medications down the toilet or pour them into a||
0460|211|R|drain unless instructed to do so. Properly discard this product||
0460|212|R|when it is expired or no longer needed. Consult your pharmacist||
0460|213|R|or local waste disposal company.||
0460|214|B|||
0460|215|M|MEDICAL ALERT:  Your condition can cause complications in a||
0460|216|M|medical emergency. For information about enrolling in MedicAlert,||
0460|217|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0460|218|B|||
0460|219|A|Information last revised September 2025.||
0460|220|A|Copyright(c) 2025 First Databank, Inc.||
0460|221|B|||
0461|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0461|002|Z|does NOT have all possible information about this product. This||
0461|003|Z|information does not assure that this product is safe, effective,||
0461|004|Z|or appropriate for you. This information is not individual||
0461|005|Z|medical advice and does not substitute for the advice of your||
0461|006|Z|health care professional. Always ask your health care||
0461|007|Z|professional for complete information about this product and your||
0461|008|Z|specific health needs.||
0461|009|B|||
0461|010|T|NATALIZUMAB - INJECTION||
0461|011|F|(NA-ta-LIZ-ue-mab)||
0461|012|B|||
0461|013|C|COMMON BRAND NAME(S): Tyruko, Tysabri||
0461|014|B|||
0461|015|W|WARNING:  Natalizumab increases your risk of getting a rare but||
0461|016|W|very serious (sometimes fatal) brain infection (progressive||
0461|017|W|multifocal leukoencephalopathy-PML). This risk may be higher the||
0461|018|W|longer you use natalizumab and if you recently used or are||
0461|019|W|currently using other medications that weaken the immune||
0461|020|W|system/increase your risk of infection (such as||
0461|021|W|immunosuppressants, cancer chemotherapy) or other medications||
0461|022|W|that affect the immune system (immunomodulators). Ask your doctor||
0461|023|W|or pharmacist for more information. See also Side Effects and||
0461|024|W|Drug Interactions sections. The risk of PML may also be higher if||
0461|025|W|you have been infected with the virus that causes this infection||
0461|026|W|(JC virus). Your doctor may order a test to see if you have been||
0461|027|W|infected with this virus. Because this medication increases the||
0461|028|W|risk of PML, it is usually used alone and only when other||
0461|029|W|treatments have not worked or you are unable to use them.||
0461|030|W|   To receive natalizumab in the United States, you must||
0461|031|W|understand, agree to, and carefully follow the requirements of||
0461|032|W|the REMS Program for this medication. If you live in Canada or||
0461|033|W|any other country, consult your doctor and pharmacist for your||
0461|034|W|country's regulations.||
0461|035|B|||
0461|036|U|USES:  Natalizumab is used to treat multiple sclerosis-MS. It is||
0461|037|U|not a cure for MS, but it is thought to help by preventing your||
0461|038|U|immune system from attacking the nerves in your brain and spinal||
0461|039|U|cord. It helps decrease the number of episodes of worsening||
0461|040|U|symptoms and may prevent or delay disability. Natalizumab is also||
0461|041|U|used to treat a bowel condition called Crohn's disease (CD). It||
0461|042|U|is not a cure for CD, but it is thought to work by preventing||
0461|043|U|your immune system from causing inflammation/swelling within your||
0461|044|U|bowels. Natalizumab is a protein called a monoclonal antibody.||
0461|045|U|   This monograph is about the following natalizumab products:||
0461|046|U|natalizumab and natalizumab-sztn.||
0461|047|B|||
0461|048|H|HOW TO USE:  Read the Medication Guide provided by your||
0461|049|H|pharmacist before you start using natalizumab and each time you||
0461|050|H|receive another dose. If you have any questions, ask your doctor||
0461|051|H|or pharmacist.||
0461|052|H|   This medication is given by injection into a vein by a health||
0461|053|H|care professional as directed by your doctor, usually every 4||
0461|054|H|weeks. This medication is usually given over 1 hour.||
0461|055|H|   Infusion reactions may happen during the infusion of this drug||
0461|056|H|and for a short time afterward. Tell your doctor right away if||
0461|057|H|you have any symptoms of infusion reactions such as chills,||
0461|058|H|fever, flushing, nausea, dizziness, tiredness, or chest pain.||
0461|059|H|   It is important to use this medication regularly to get the||
0461|060|H|most benefit from it. Do not miss any doses without your doctor's||
0461|061|H|approval.||
0461|062|H|   Tell your doctor if your condition gets worse. When using this||
0461|063|H|medication for Crohn's disease, if your condition does not get||
0461|064|H|better after 12 weeks of treatment, your doctor will need to||
0461|065|H|switch your treatment plan.||
0461|066|B|||
0461|067|S|SIDE EFFECTS:  See also How to Use section.||
0461|068|S|   Headache, joint pain, redness/irritation at the injection||
0461|069|S|site, swelling hands/feet/ankles, or changes in menstrual cycle||
0461|070|S|may occur. If any of these effects last or get worse, tell your||
0461|071|S|doctor or pharmacist promptly.||
0461|072|S|   Remember that this medication has been prescribed because your||
0461|073|S|doctor has judged that the benefit to you is greater than the||
0461|074|S|risk of side effects. Many people using this medication do not||
0461|075|S|have serious side effects.||
0461|076|S|   Tell your doctor right away if you have any serious side||
0461|077|S|effects, including: headache that is severe or doesn't go away,||
0461|078|S|stiff/painful neck, fast/pounding heartbeat, easy||
0461|079|S|bruising/bleeding, signs of infection (such as sore throat that||
0461|080|S|doesn't go away, fever, chills, unusual vaginal discharge,||
0461|081|S|painful/frequent urination), mood changes (such as depression,||
0461|082|S|suicidal thoughts), severe stomach/abdominal pain.||
0461|083|S|   This drug increases the risk of a rare, possibly fatal, brain||
0461|084|S|infection (see Warning section for more details). This condition||
0461|085|S|may occur during treatment or, in some cases, after treatment has||
0461|086|S|stopped. In MS patients, the symptoms of PML can seem like an||
0461|087|S|attack of worsening MS. Whether you are using this drug or have||
0461|088|S|stopped using it within the last 6 months, tell your doctor right||
0461|089|S|away of any new or worsening symptoms that have lasted for||
0461|090|S|several days such as: clumsiness, sudden change in your thinking||
0461|091|S|(such as confusion, difficulty concentrating), difficulty moving||
0461|092|S|muscles, seizure, problems with speech, vision changes.||
0461|093|S|   This drug may rarely cause serious liver problems. If you||
0461|094|S|notice any of the following rare but very serious side effects,||
0461|095|S|tell your doctor right away: nausea/vomiting that doesn't stop,||
0461|096|S|dark urine, yellowing eyes/skin, feeling tired/weak.||
0461|097|S|   A very serious allergic reaction to this drug is rare.||
0461|098|S|However, get medical help right away if you notice any symptoms||
0461|099|S|of a serious allergic reaction, including: rash, itching/swelling||
0461|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0461|101|S|breathing.||
0461|102|S|   This is not a complete list of possible side effects. If you||
0461|103|S|notice other effects not listed above, contact your doctor or||
0461|104|S|pharmacist.||
0461|105|S|   In the US -||
0461|106|S|   Call your doctor for medical advice about side effects. You||
0461|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0461|108|S|www.fda.gov/medwatch.||
0461|109|S|   In Canada - Call your doctor for medical advice about side||
0461|110|S|effects. You may report side effects to Health Canada at||
0461|111|S|1-866-234-2345.||
0461|112|B|||
0461|113|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0461|114|P|pharmacist if you are allergic to it; or to other natalizumab||
0461|115|P|products; or if you have any other allergies. This product may||
0461|116|P|contain inactive ingredients, which can cause allergic reactions||
0461|117|P|or other problems. Talk to your pharmacist for more details.||
0461|118|P|   Before using this medication, tell your doctor or pharmacist||
0461|119|P|your medical history, especially of: a certain virus infection||
0461|120|P|(progressive multifocal leukoencephalopathy-PML), history of||
0461|121|P|certain virus infections that keep coming back (such as herpes,||
0461|122|P|shingles), weakened immune system (such as leukemia, lymphoma,||
0461|123|P|HIV infection, organ transplant), current infections, mental/mood||
0461|124|P|disorders (such as depression).||
0461|125|P|   Before having surgery, tell your doctor or dentist about all||
0461|126|P|the products you use (including prescription drugs,||
0461|127|P|nonprescription drugs, and herbal products).||
0461|128|P|   During pregnancy, this medication should be used only when||
0461|129|P|clearly needed. Babies born to mothers who have used this drug||
0461|130|P|during pregnancy may have low platelet and red blood cell counts.||
0461|131|P|Tell the doctor right away if your baby develops easy||
0461|132|P|bruising/bleeding. Discuss the risks and benefits with your||
0461|133|P|doctor.||
0461|134|P|   It is unknown if this drug passes into breast milk. Because of||
0461|135|P|the possible risk to the infant, breastfeeding is not recommended||
0461|136|P|while using this drug. Consult your doctor before breastfeeding.||
0461|137|B|||
0461|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0461|139|I|medications work or increase your risk for serious side effects.||
0461|140|I|This document does not contain all possible drug interactions.||
0461|141|I|Keep a list of all the products you use (including||
0461|142|I|prescription/nonprescription drugs and herbal products) and share||
0461|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
0461|144|I|the dosage of any medicines without your doctor's approval.||
0461|145|I|   Some products that may interact with this drug include: past||
0461|146|I|or current use of other drugs that weaken the immune||
0461|147|I|system/increase the risk of infection (such as azathioprine,||
0461|148|I|cyclosporine, 6-mercaptopurine, methotrexate, fingolimod, TNF||
0461|149|I|blockers such as adalimumab, etanercept, infliximab), long-term||
0461|150|I|use of corticosteroids (such as dexamethasone, prednisone).||
0461|151|B|||
0461|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0461|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0461|154|O|poison control center right away. US residents can call||
0461|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0461|156|B|||
0461|157|N|NOTES:  Lab and/or medical tests (such as MRI, liver function,||
0461|158|N|anti-JCV antibody test) may be done before you start using this||
0461|159|N|medication and while you are using it. Keep all medical and lab||
0461|160|N|appointments. Consult your doctor for more details.||
0461|161|N|   Talk to your doctor or pharmacist about lifestyle changes that||
0461|162|N|might benefit you. Examples of lifestyle changes include stress||
0461|163|N|reduction programs and maintaining a healthy diet. A||
0461|164|N|doctor-approved exercise program may also help MS patients||
0461|165|N|maintain strength, balance, and muscle tone. Consult your doctor||
0461|166|N|or pharmacist for more details.||
0461|167|B|||
0461|168|D|MISSED DOSE:  It is important to get each dose of this medication||
0461|169|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0461|170|D|right away for a new dosing schedule.||
0461|171|B|||
0461|172|R|STORAGE:  Not applicable. This medication is given in an infusion||
0461|173|R|center and will not be stored at home.||
0461|174|B|||
0461|175|M|MEDICAL ALERT:  Your condition can cause complications in a||
0461|176|M|medical emergency. For information about enrolling in MedicAlert,||
0461|177|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0461|178|B|||
0461|179|A|Information last revised September 2025.||
0461|180|A|Copyright(c) 2025 First Databank, Inc.||
0461|181|B|||
0462|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0462|002|Z|does NOT have all possible information about this product. This||
0462|003|Z|information does not assure that this product is safe, effective,||
0462|004|Z|or appropriate for you. This information is not individual||
0462|005|Z|medical advice and does not substitute for the advice of your||
0462|006|Z|health care professional. Always ask your health care||
0462|007|Z|professional for complete information about this product and your||
0462|008|Z|specific health needs.||
0462|009|B|||
0462|010|T|FLURBIPROFEN - ORAL||
0462|011|F|(FLUR-bi-PROE-fen)||
0462|012|B|||
0462|013|C|COMMON BRAND NAME(S): Ansaid||
0462|014|B|||
0462|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0462|016|W|flurbiprofen) may rarely increase the risk of a heart attack or||
0462|017|W|stroke. This effect can happen at any time while taking this drug||
0462|018|W|but is more likely if you take it for a long time. The risk may||
0462|019|W|be greater in older adults or if you have heart disease or||
0462|020|W|increased risk for heart disease (for example, due to smoking,||
0462|021|W|family history of heart disease, or conditions such as high blood||
0462|022|W|pressure or diabetes). Do not take this drug right before or||
0462|023|W|after heart bypass surgery (CABG).||
0462|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0462|025|W|bleeding from the stomach or intestines. This effect can occur||
0462|026|W|without warning symptoms at any time while taking this drug.||
0462|027|W|Older adults may be at higher risk for this effect.||
0462|028|W|   Stop taking flurbiprofen and get medical help right away if||
0462|029|W|you notice any of these rare but serious side effects:||
0462|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0462|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0462|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0462|033|W|side of the body, trouble speaking, sudden vision changes.||
0462|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0462|035|W|of taking this drug.||
0462|036|B|||
0462|037|U|USES:  See also Warning section.||
0462|038|U|   Flurbiprofen is used to reduce pain, swelling, and joint||
0462|039|U|stiffness from arthritis. It is also used to relieve pain from||
0462|040|U|various conditions such as dental pain, menstrual cramps, and||
0462|041|U|muscle aches.||
0462|042|U|   Flurbiprofen is known as a nonsteroidal anti-inflammatory drug||
0462|043|U|(NSAID). It works by blocking your body's production of certain||
0462|044|U|natural substances that cause inflammation. This effect helps to||
0462|045|U|decrease swelling and pain.||
0462|046|U|   If you are treating a chronic condition such as arthritis, ask||
0462|047|U|your doctor about non-drug treatments and/or using other||
0462|048|U|medications to treat your pain.||
0462|049|B|||
0462|050|V|OTHER USES:  This section contains uses of this drug that are not||
0462|051|V|listed in the approved professional labeling for the drug but||
0462|052|V|that may be prescribed by your health care professional. Use this||
0462|053|V|drug for a condition that is listed in this section only if it||
0462|054|V|has been so prescribed by your health care professional.||
0462|055|V|   This medication may also be used for arthritis of the spine or||
0462|056|V|gout attacks.||
0462|057|B|||
0462|058|H|HOW TO USE:  Read the Medication Guide provided by your||
0462|059|H|pharmacist before you start taking flurbiprofen and each time you||
0462|060|H|get a refill. If you have any questions, ask your doctor or||
0462|061|H|pharmacist.||
0462|062|H|   Take this medication by mouth as directed by your doctor,||
0462|063|H|usually 2 to 4 times daily. Take this medication with a full||
0462|064|H|glass of water (8 ounces or 240 milliliters) unless your doctor||
0462|065|H|directs you otherwise. Do not lie down for at least 10 minutes||
0462|066|H|after taking this medication. If stomach upset occurs while||
0462|067|H|taking this medication, take it with food, milk, or an antacid.||
0462|068|H|   The dosage is based on your medical condition and response to||
0462|069|H|treatment. To reduce your risk of stomach bleeding and other side||
0462|070|H|effects, take this medication at the lowest effective dose for||
0462|071|H|the shortest possible time. Do not increase your dose or use this||
0462|072|H|drug more often or for longer than prescribed. For ongoing||
0462|073|H|conditions such as arthritis, keep taking this medication as||
0462|074|H|directed. Discuss the risks and benefits with your doctor or||
0462|075|H|pharmacist.||
0462|076|H|   For certain conditions (such as arthritis), it may take up to||
0462|077|H|2 weeks of taking this drug regularly until you get the full||
0462|078|H|benefit.||
0462|079|H|   If you are taking this drug "as needed" (not on a regular||
0462|080|H|schedule), remember that pain medications work best if they are||
0462|081|H|used as the first signs of pain occur. If you wait until the pain||
0462|082|H|has worsened, the medicine may not work as well.||
0462|083|H|   Tell your doctor if your condition gets worse.||
0462|084|B|||
0462|085|S|SIDE EFFECTS:  See also Warning section.||
0462|086|S|   Upset stomach, diarrhea, heartburn, nausea, dizziness, or||
0462|087|S|drowsiness may occur. If any of these effects last or get worse,||
0462|088|S|tell your doctor or pharmacist promptly.||
0462|089|S|   Remember that this medication has been prescribed because your||
0462|090|S|doctor has judged that the benefit to you is greater than the||
0462|091|S|risk of side effects. Many people using this medication do not||
0462|092|S|have serious side effects.||
0462|093|S|   This medication may raise your blood pressure. Check your||
0462|094|S|blood pressure regularly and tell your doctor if the results are||
0462|095|S|high.||
0462|096|S|   Tell your doctor right away if you have any serious side||
0462|097|S|effects, including: hearing changes (such as ringing in the||
0462|098|S|ears), mental/mood changes, easy bleeding/bruising,||
0462|099|S|difficult/painful swallowing, signs of kidney problems (such as||
0462|100|S|change in the amount of urine, pink/bloody urine), symptoms of||
0462|101|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
0462|102|S|unusual/sudden weight gain).||
0462|103|S|   Flurbiprofen may rarely cause serious (possibly fatal) liver||
0462|104|S|disease. Get medical help right away if you have any symptoms of||
0462|105|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0462|106|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0462|107|S|urine.||
0462|108|S|   A very serious allergic reaction to this drug is rare.||
0462|109|S|However, get medical help right away if you notice any symptoms||
0462|110|S|of a serious allergic reaction, including: fever, swollen lymph||
0462|111|S|nodes, rash, itching/swelling (especially of the||
0462|112|S|face/tongue/throat), severe dizziness, trouble breathing.||
0462|113|S|   This is not a complete list of possible side effects. If you||
0462|114|S|notice other effects not listed above, contact your doctor or||
0462|115|S|pharmacist.||
0462|116|S|   In the US -||
0462|117|S|   Call your doctor for medical advice about side effects. You||
0462|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0462|119|S|www.fda.gov/medwatch.||
0462|120|S|   In Canada - Call your doctor for medical advice about side||
0462|121|S|effects. You may report side effects to Health Canada at||
0462|122|S|1-866-234-2345.||
0462|123|B|||
0462|124|P|PRECAUTIONS:  See also Warning section.||
0462|125|P|   Before taking flurbiprofen, tell your doctor or pharmacist if||
0462|126|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
0462|127|P|ibuprofen, naproxen, celecoxib); or if you have any other||
0462|128|P|allergies. This product may contain inactive ingredients, which||
0462|129|P|can cause allergic reactions or other problems. Talk to your||
0462|130|P|pharmacist for more details.||
0462|131|P|   Before using this medication, tell your doctor or pharmacist||
0462|132|P|your medical history, especially of: asthma (including a history||
0462|133|P|of worsening breathing after taking aspirin or other NSAIDs),||
0462|134|P|bleeding/clotting problems, blood disorders (such as anemia),||
0462|135|P|diabetes, growths in the nose (nasal polyps), heart disease (such||
0462|136|P|as history of heart attack), high blood pressure, liver disease,||
0462|137|P|stroke, swelling (edema, fluid retention),||
0462|138|P|stomach/intestine/esophagus problems (such as bleeding,||
0462|139|P|heartburn, ulcers).||
0462|140|P|   Kidney problems can sometimes occur with the use of NSAID||
0462|141|P|medications, including flurbiprofen. Problems are more likely to||
0462|142|P|occur if you are dehydrated, have heart failure or kidney||
0462|143|P|disease, are an older adult, or if you take certain medications||
0462|144|P|(see also Drug Interactions section). Drink plenty of fluids as||
0462|145|P|directed by your doctor to prevent dehydration and tell your||
0462|146|P|doctor right away if you have pink/bloody urine or any unusual||
0462|147|P|change in the amount of urine.||
0462|148|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0462|149|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0462|150|P|machinery, or do anything that needs alertness until you can do||
0462|151|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0462|152|P|are using marijuana (cannabis).||
0462|153|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0462|154|P|and tobacco, especially when combined with this medicine, may||
0462|155|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0462|156|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
0462|157|P|may safely drink.||
0462|158|P|   This medication may make you more sensitive to the sun. Limit||
0462|159|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0462|160|P|sunscreen and wear protective clothing when outdoors. Tell your||
0462|161|P|doctor right away if you get sunburned or have skin||
0462|162|P|blisters/redness.||
0462|163|P|   Before having surgery, tell your doctor or dentist about all||
0462|164|P|the products you use (including prescription drugs,||
0462|165|P|nonprescription drugs, and herbal products).||
0462|166|P|   Older adults may be at greater risk for stomach/intestinal||
0462|167|P|bleeding, kidney problems, heart attack, and stroke while using||
0462|168|P|this drug.||
0462|169|P|   Before using this medication, women of childbearing age should||
0462|170|P|talk with their doctor(s) about the benefits and risks. Tell your||
0462|171|P|doctor if you are pregnant or if you plan to become pregnant.||
0462|172|P|This medication may harm an unborn baby and cause problems with||
0462|173|P|normal labor/delivery. It is not recommended for use in pregnancy||
0462|174|P|from 20 weeks until delivery. If your doctor decides that you||
0462|175|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0462|176|P|you should use the lowest effective dose for the shortest||
0462|177|P|possible time. You should not use this medication after 30 weeks||
0462|178|P|of pregnancy.||
0462|179|P|   This medication passes into breast milk. Consult your doctor||
0462|180|P|before breastfeeding.||
0462|181|B|||
0462|182|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0462|183|I|medications work or increase your risk for serious side effects.||
0462|184|I|This document does not contain all possible drug interactions.||
0462|185|I|Keep a list of all the products you use (including||
0462|186|I|prescription/nonprescription drugs and herbal products) and share||
0462|187|I|it with your doctor and pharmacist. Do not start, stop, or change||
0462|188|I|the dosage of any medicines without your doctor's approval.||
0462|189|I|   Some products that may interact with this drug are: aliskiren,||
0462|190|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
0462|191|I|receptor blockers (such as losartan, valsartan), cidofovir,||
0462|192|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
0462|193|I|methotrexate, "water pills" (diuretics such as furosemide).||
0462|194|I|   This medication may increase the risk of bleeding when taken||
0462|195|I|with other drugs that also may cause bleeding. Examples include||
0462|196|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0462|197|I|dabigatran/enoxaparin/warfarin, among others.||
0462|198|I|   Check all prescription and nonprescription medicine labels||
0462|199|I|carefully since many medications contain pain relievers/fever||
0462|200|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
0462|201|I|naproxen). These drugs are similar to flurbiprofen and may||
0462|202|I|increase your risk of side effects if taken together. However, if||
0462|203|I|your doctor has told you to take low-dose aspirin to prevent||
0462|204|I|heart attack or stroke (usually 81-162 milligrams a day), you||
0462|205|I|should keep taking the aspirin unless your doctor tells you not||
0462|206|I|to. Ask your doctor or pharmacist for more details.||
0462|207|B|||
0462|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0462|209|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0462|210|O|poison control center right away. US residents can call||
0462|211|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0462|212|O|Symptoms of overdose may include: severe stomach pain,||
0462|213|O|slow/shallow breathing, extreme drowsiness, loss of||
0462|214|O|consciousness.||
0462|215|B|||
0462|216|N|NOTES:  Do not share this medication with others.||
0462|217|N|   Lab and/or medical tests (such as complete blood counts, liver||
0462|218|N|and kidney function, blood pressure) may be done while you are||
0462|219|N|using this medication. Keep all medical and lab appointments.||
0462|220|N|Consult your doctor for more details.||
0462|221|N|   Lifestyle changes (such as weight loss if needed,||
0462|222|N|strengthening/conditioning exercises) may help improve your||
0462|223|N|flexibility and joint function. Consult your doctor for specific||
0462|224|N|instructions.||
0462|225|B|||
0462|226|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
0462|227|D|(not just "as needed") and you miss a dose, take it as soon as||
0462|228|D|you remember. If it is near the time of the next dose, skip the||
0462|229|D|missed dose. Take your next dose at the regular time. Do not||
0462|230|D|double the dose to catch up.||
0462|231|B|||
0462|232|R|STORAGE:  Store at room temperature away from light and moisture.||
0462|233|R|Do not store in the bathroom. Keep all medications away from||
0462|234|R|children and pets.||
0462|235|R|   Do not flush medications down the toilet or pour them into a||
0462|236|R|drain unless instructed to do so. Properly discard this product||
0462|237|R|when it is expired or no longer needed. Consult your pharmacist||
0462|238|R|or local waste disposal company.||
0462|239|B|||
0462|240|A|Information last revised May 2024.||
0462|241|A|Copyright(c) 2025 First Databank, Inc.||
0462|242|B|||
0463|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0463|002|Z|does NOT have all possible information about this product. This||
0463|003|Z|information does not assure that this product is safe, effective,||
0463|004|Z|or appropriate for you. This information is not individual||
0463|005|Z|medical advice and does not substitute for the advice of your||
0463|006|Z|health care professional. Always ask your health care||
0463|007|Z|professional for complete information about this product and your||
0463|008|Z|specific health needs.||
0463|009|B|||
0463|010|T|DOXYCYCLINE DELAYED-RELEASE - ORAL||
0463|011|F|(DOX-i-SYE-kleen)||
0463|012|B|||
0463|013|C|COMMON BRAND NAME(S): Doryx||
0463|014|B|||
0463|015|U|USES:  This medication is used to treat a wide variety of||
0463|016|U|bacterial infections, including those that cause acne. This||
0463|017|U|medication is also used to prevent malaria. This medication is||
0463|018|U|known as a tetracycline antibiotic. It works by stopping the||
0463|019|U|growth of bacteria.||
0463|020|U|   This antibiotic treats only bacterial infections. It will not||
0463|021|U|work for viral infections (such as common cold, flu). Using any||
0463|022|U|antibiotic when it is not needed can cause it to not work for||
0463|023|U|future infections.||
0463|024|B|||
0463|025|V|OTHER USES:  This section contains uses of this drug that are not||
0463|026|V|listed in the approved professional labeling for the drug but||
0463|027|V|that may be prescribed by your health care professional. Use this||
0463|028|V|drug for a condition that is listed in this section only if it||
0463|029|V|has been so prescribed by your health care professional.||
0463|030|V|   This drug may also be used for a certain skin condition||
0463|031|V|(rosacea).||
0463|032|B|||
0463|033|H|HOW TO USE:  Take this medication by mouth as directed by your||
0463|034|H|doctor, usually 1 or 2 times daily. Take this medication with a||
0463|035|H|full glass of water (8 ounces/240 milliliters) unless directed||
0463|036|H|otherwise. Do not lie down for at least 10 minutes after taking||
0463|037|H|this medication. Your doctor may direct you to take this||
0463|038|H|medication with or right after food or milk to reduce stomach||
0463|039|H|upset. Follow your doctor's directions on how to take this||
0463|040|H|medication.||
0463|041|H|   Take this medication 2 to 3 hours before or after taking any||
0463|042|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
0463|043|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
0463|044|H|sucralfate, and vitamins/minerals. These products bind with||
0463|045|H|doxycycline, preventing your body from fully absorbing the drug.||
0463|046|H|   When using to prevent malaria, take this medication as||
0463|047|H|directed by your doctor, usually once daily, starting 1 to 2 days||
0463|048|H|before travel. Continue to take this medication daily while in||
0463|049|H|the malarious area. Upon returning home, you should keep taking||
0463|050|H|this medication for 4 more weeks. If you are unable to finish||
0463|051|H|this course of doxycycline, contact your doctor.||
0463|052|H|   Do not crush or chew the medication. Swallow the capsules||
0463|053|H|whole. If you have difficulty swallowing the capsule, the capsule||
0463|054|H|may be opened and the contents sprinkled onto cool applesauce and||
0463|055|H|taken immediately as directed. If you have difficulty swallowing||
0463|056|H|the tablet, the tablet may be broken up carefully and the||
0463|057|H|contents (pellets) sprinkled onto cool applesauce and taken||
0463|058|H|immediately as directed. Make sure not to crush or damage the||
0463|059|H|pellets when breaking up the tablet. Do not prepare a supply in||
0463|060|H|advance. Do not chew the food/medication mixture because doing so||
0463|061|H|may cause the drug to be released too quickly, increasing side||
0463|062|H|effects. Drink a glass of cool water after each dose to ensure||
0463|063|H|complete swallowing of the medication.||
0463|064|H|   The dosage is based on your medical condition and response to||
0463|065|H|treatment. Children's dosage may also be based on weight.||
0463|066|H|   For the best effect, take this antibiotic at evenly spaced||
0463|067|H|times. To help you remember, take this medication at the same||
0463|068|H|time(s) every day.||
0463|069|H|   Continue to take this medication until the full prescribed||
0463|070|H|amount is finished, even if symptoms disappear after a few days.||
0463|071|H|Stopping the medication too early may result in a return of the||
0463|072|H|infection.||
0463|073|H|   Tell your doctor if your condition lasts or gets worse.||
0463|074|B|||
0463|075|S|SIDE EFFECTS:  Stomach upset, diarrhea, nausea, or vomiting may||
0463|076|S|occur. If any of these effects last or get worse, tell your||
0463|077|S|doctor or pharmacist promptly.||
0463|078|S|   Remember that this medication has been prescribed because your||
0463|079|S|doctor has judged that the benefit to you is greater than the||
0463|080|S|risk of side effects. Many people using this medication do not||
0463|081|S|have serious side effects.||
0463|082|S|   Tell your doctor right away if you have any serious side||
0463|083|S|effects, including: painful/difficult swallowing, signs of kidney||
0463|084|S|problems (such as change in the amount of urine).||
0463|085|S|   Tetracycline drugs such as doxycycline may rarely cause||
0463|086|S|increased pressure around the brain (intracranial||
0463|087|S|hypertension-IH). The risk of this side effect is greater for||
0463|088|S|women of childbearing age who are overweight or who have had IH||
0463|089|S|in the past. If IH develops, it usually goes away after||
0463|090|S|doxycycline is stopped; however, there is a chance of permanent||
0463|091|S|vision loss or blindness. Get medical help right away if you||
0463|092|S|have: headache that is severe or doesn't stop, nausea/vomiting||
0463|093|S|that doesn't stop, vision changes (such as blurred/double vision,||
0463|094|S|decreased vision, sudden blindness).||
0463|095|S|   This medication may rarely cause a severe intestinal condition||
0463|096|S|due to a bacteria called C. difficile. This condition may occur||
0463|097|S|during treatment or weeks to months after treatment has stopped.||
0463|098|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0463|099|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0463|100|S|stool.||
0463|101|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0463|102|S|products because they may make symptoms worse.||
0463|103|S|   Use of this medication for prolonged or repeated periods may||
0463|104|S|result in oral thrush or a new vaginal yeast infection. Contact||
0463|105|S|your doctor if you notice white patches in your mouth, a change||
0463|106|S|in vaginal discharge, or other new symptoms.||
0463|107|S|   A very serious allergic reaction to this drug is rare.||
0463|108|S|However, get medical help right away if you notice any symptoms||
0463|109|S|of a serious allergic reaction, including: fever that doesn't go||
0463|110|S|away, new or worsening lymph node swelling, rash,||
0463|111|S|itching/swelling (especially of the face/tongue/throat), severe||
0463|112|S|dizziness, trouble breathing.||
0463|113|S|   This is not a complete list of possible side effects. If you||
0463|114|S|notice other effects not listed above, contact your doctor or||
0463|115|S|pharmacist.||
0463|116|S|   In the US -||
0463|117|S|   Call your doctor for medical advice about side effects. You||
0463|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0463|119|S|www.fda.gov/medwatch.||
0463|120|S|   In Canada - Call your doctor for medical advice about side||
0463|121|S|effects. You may report side effects to Health Canada at||
0463|122|S|1-866-234-2345.||
0463|123|B|||
0463|124|P|PRECAUTIONS:  See also Side Effects section.||
0463|125|P|   Before taking doxycycline, tell your doctor or pharmacist if||
0463|126|P|you are allergic to it; or to other tetracyclines (such as||
0463|127|P|minocycline); or if you have any other allergies. This product||
0463|128|P|may contain inactive ingredients, which can cause allergic||
0463|129|P|reactions or other problems. Talk to your pharmacist for more||
0463|130|P|details.||
0463|131|P|   Before using this medication, tell your doctor or pharmacist||
0463|132|P|your medical history, especially of: trouble swallowing,||
0463|133|P|esophagus problems (such as hiatal hernia or reflux/heartburn).||
0463|134|P|   Doxycycline may cause live bacterial vaccines (such as typhoid||
0463|135|P|vaccine) to not work well. Tell your health care professional||
0463|136|P|that you are using doxycycline before having any||
0463|137|P|immunizations/vaccinations.||
0463|138|P|   Before having surgery, tell your doctor or dentist about all||
0463|139|P|the products you use (including prescription drugs,||
0463|140|P|nonprescription drugs, and herbal products).||
0463|141|P|   This medication may make you more sensitive to the sun. Limit||
0463|142|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0463|143|P|sunscreen and wear protective clothing when outdoors. Tell your||
0463|144|P|doctor right away if you get sunburned or have skin||
0463|145|P|blisters/redness.||
0463|146|P|   Children younger than 8 years may be more sensitive to the||
0463|147|P|side effects of doxycycline, especially tooth discoloration.||
0463|148|P|Tooth discoloration has also occurred in older children and young||
0463|149|P|adults. Discuss the risks and benefits of this medication with||
0463|150|P|the doctor.||
0463|151|P|   Tell your doctor if you are pregnant or plan to become||
0463|152|P|pregnant. You should not become pregnant while using doxycycline.||
0463|153|P|Doxycycline may harm an unborn baby. If you become pregnant, talk||
0463|154|P|to your doctor right away about the risks and benefits of this||
0463|155|P|medication.||
0463|156|P|   This medication passes into breast milk. Consult your doctor||
0463|157|P|before breastfeeding.||
0463|158|B|||
0463|159|I|DRUG INTERACTIONS:  See also How to Use section.||
0463|160|I|   Drug interactions may change how your medications work or||
0463|161|I|increase your risk for serious side effects. This document does||
0463|162|I|not contain all possible drug interactions. Keep a list of all||
0463|163|I|the products you use (including prescription/nonprescription||
0463|164|I|drugs and herbal products) and share it with your doctor and||
0463|165|I|pharmacist. Do not start, stop, or change the dosage of any||
0463|166|I|medicines without your doctor's approval.||
0463|167|I|   Some products that may interact with this drug include:||
0463|168|I|retinoid medications taken by mouth (such as acitretin,||
0463|169|I|isotretinoin), strontium.||
0463|170|I|   This medication may interfere with certain lab tests (such as||
0463|171|I|urine catecholamine levels), possibly causing false test results.||
0463|172|I|Make sure lab personnel and all your doctors know you use this||
0463|173|I|drug.||
0463|174|B|||
0463|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0463|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0463|177|O|poison control center right away. US residents can call||
0463|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0463|179|B|||
0463|180|N|NOTES:  Do not share this medication with others.||
0463|181|N|   If this medication is being used to prevent malaria, it is||
0463|182|N|important to understand that it is still possible to get the||
0463|183|N|disease even if you have used this medication. Avoid being bitten||
0463|184|N|by mosquitoes when trying to prevent malaria. Avoid contact with||
0463|185|N|mosquitoes, especially from dusk to dawn, by staying in||
0463|186|N|well-screened areas, wearing protective clothing, and using||
0463|187|N|insect repellent and bed nets.||
0463|188|N|   This medication has been prescribed for your current condition||
0463|189|N|only. Do not use it later for another infection unless your||
0463|190|N|doctor tells you to.||
0463|191|N|   Lab and/or medical tests (such as complete blood count,||
0463|192|N|liver/kidney function) may be done while you are taking this||
0463|193|N|medication. Keep all medical and lab appointments. Consult your||
0463|194|N|doctor for more details.||
0463|195|B|||
0463|196|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0463|197|D|remember. If it is near the time of the next dose, skip the||
0463|198|D|missed dose. Take your next dose at the regular time. Do not||
0463|199|D|double the dose to catch up.||
0463|200|B|||
0463|201|R|STORAGE:  Store at room temperature away from light and moisture.||
0463|202|R|Different brands of this medication have different storage needs.||
0463|203|R|Check the product package for instructions on how to store your||
0463|204|R|brand, or ask your pharmacist. Do not store in the bathroom. Keep||
0463|205|R|all medications away from children and pets.||
0463|206|R|   Do not flush medications down the toilet or pour them into a||
0463|207|R|drain unless instructed to do so. Properly discard this product||
0463|208|R|when it is expired or no longer needed. Taking outdated||
0463|209|R|tetracycline-related drugs can result in serious illness. Consult||
0463|210|R|your pharmacist or local waste disposal company.||
0463|211|B|||
0463|212|A|Information last revised September 2025.||
0463|213|A|Copyright(c) 2025 First Databank, Inc.||
0463|214|B|||
0464|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0464|002|Z|does NOT have all possible information about this product. This||
0464|003|Z|information does not assure that this product is safe, effective,||
0464|004|Z|or appropriate for you. This information is not individual||
0464|005|Z|medical advice and does not substitute for the advice of your||
0464|006|Z|health care professional. Always ask your health care||
0464|007|Z|professional for complete information about this product and your||
0464|008|Z|specific health needs.||
0464|009|B|||
0464|010|T|ZICONOTIDE - INJECTION||
0464|011|F|(zye-KON-oh-tide)||
0464|012|B|||
0464|013|C|COMMON BRAND NAME(S): Prialt||
0464|014|B|||
0464|015|W|WARNING:  Severe mental/mood changes (such as confusion,||
0464|016|W|depression, hallucinations, decreased alertness) may occur in||
0464|017|W|some patients. This medication should not be used if you have a||
0464|018|W|history of certain mental disorders (such as psychosis) because||
0464|019|W|it increases the risk of those side effects.||
0464|020|B|||
0464|021|U|USES:  This medication is a non-opioid pain reliever that is used||
0464|022|U|to treat ongoing pain when other treatments or medications cannot||
0464|023|U|control your pain. Ziconotide works by blocking the nerves in the||
0464|024|U|spinal cord that send pain signals. It decreases ongoing pain||
0464|025|U|caused by cancer, AIDS, failed back surgery, multiple sclerosis,||
0464|026|U|neuropathy, and other causes.||
0464|027|B|||
0464|028|H|HOW TO USE:  Read the instruction manual and directions that come||
0464|029|H|with your infusion pump. If you have any questions, ask your||
0464|030|H|doctor or pharmacist.||
0464|031|H|   This medication is given by injection as directed by your||
0464|032|H|doctor, usually continuously into area around the spinal cord||
0464|033|H|(intrathecal) using a small pump. To decrease the risk of side||
0464|034|H|effects, treatment is usually started slowly and then gradually||
0464|035|H|increased to the best dose for you. The dosage is based on your||
0464|036|H|medical condition and response to treatment.||
0464|037|H|   This medication should not be given into a vein or under the||
0464|038|H|skin. It can cause fainting due to a dangerous drop in blood||
0464|039|H|pressure if it is accidentally given into a vein.||
0464|040|H|   If you are giving this medication to yourself at home, learn||
0464|041|H|all preparation and usage instructions from your health care||
0464|042|H|professional. Before using, check this product for particles or||
0464|043|H|discoloration. If either is present, do not use the liquid. Learn||
0464|044|H|how to store and discard medical supplies safely.||
0464|045|H|   To prevent infection, learn how to handle the infusion pump,||
0464|046|H|and learn proper care of the injection site. Call your doctor||
0464|047|H|right away if there is any sign of infection around the injection||
0464|048|H|site (such as swelling, redness, tenderness).||
0464|049|H|   Contact your doctor or pharmacist to set up a schedule for||
0464|050|H|refilling your pump.||
0464|051|H|   Tell your doctor if your pain lasts or gets worse.||
0464|052|B|||
0464|053|S|SIDE EFFECTS:  See also How to Use section.||
0464|054|S|   Dizziness, drowsiness, nausea, headache, and weakness may||
0464|055|S|occur. If any of these effects last or get worse, tell your||
0464|056|S|doctor or pharmacist promptly.||
0464|057|S|   Remember that this medication has been prescribed because your||
0464|058|S|doctor has judged that the benefit to you is greater than the||
0464|059|S|risk of side effects. Many people using this medication do not||
0464|060|S|have serious side effects.||
0464|061|S|   Tell your doctor right away if you have any serious side||
0464|062|S|effects, including: decreased alertness (unresponsiveness),||
0464|063|S|memory problems, mental/mood changes (such as agitation,||
0464|064|S|depression, hallucinations, thoughts of suicide), new or||
0464|065|S|worsening muscle pain/soreness, numbness/tingling, trouble||
0464|066|S|speaking/swallowing, difficult/unsteady walking, trouble||
0464|067|S|urinating, dark urine, vision changes.||
0464|068|S|   A very serious infection (meningitis) may occur if the site of||
0464|069|S|your infusion or the solution going into your spinal cord becomes||
0464|070|S|contaminated. Get medical help right away if you have any||
0464|071|S|symptoms of meningitis, including confusion, high fever,||
0464|072|S|seizures, severe headache, stiff/painful neck, vomiting.||
0464|073|S|   A very serious allergic reaction to this drug is rare.||
0464|074|S|However, get medical help right away if you notice any symptoms||
0464|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0464|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0464|077|S|breathing.||
0464|078|S|   This is not a complete list of possible side effects. If you||
0464|079|S|notice other effects not listed above, contact your doctor or||
0464|080|S|pharmacist.||
0464|081|S|   In the US -||
0464|082|S|   Call your doctor for medical advice about side effects. You||
0464|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0464|084|S|www.fda.gov/medwatch.||
0464|085|S|   In Canada - Call your doctor for medical advice about side||
0464|086|S|effects. You may report side effects to Health Canada at||
0464|087|S|1-866-234-2345.||
0464|088|B|||
0464|089|P|PRECAUTIONS:  See also Warning section.||
0464|090|P|   Before using ziconotide, tell your doctor or pharmacist if you||
0464|091|P|are allergic to it; or if you have any other allergies. This||
0464|092|P|product may contain inactive ingredients, which can cause||
0464|093|P|allergic reactions or other problems. Talk to your pharmacist for||
0464|094|P|more details.||
0464|095|P|   Before using this medication, tell your doctor or pharmacist||
0464|096|P|your medical history, especially of: mental/mood disorders (such||
0464|097|P|as depression, psychosis, thoughts of suicide).||
0464|098|P|   This medication is not an opioid (morphine-like drug). If you||
0464|099|P|have been using an opioid (such as codeine, hydrocodone,||
0464|100|P|morphine) regularly for more than a few weeks, or if it has been||
0464|101|P|used in high doses, you may be dependent on it. In such cases, if||
0464|102|P|you suddenly stop the opioid, withdrawal reactions may occur.||
0464|103|P|This medication will not prevent withdrawal reactions from||
0464|104|P|opioids. When stopping extended, regular treatment with opioids,||
0464|105|P|gradually reducing the dosage as directed will help prevent||
0464|106|P|withdrawal reactions. Consult your doctor or pharmacist for more||
0464|107|P|details.||
0464|108|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0464|109|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0464|110|P|machinery, or do anything that needs alertness until you can do||
0464|111|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0464|112|P|are using marijuana (cannabis).||
0464|113|P|   Before having surgery, tell your doctor or dentist about all||
0464|114|P|the products you use (including prescription drugs,||
0464|115|P|nonprescription drugs, and herbal products).||
0464|116|P|   Older adults may be more sensitive to the side effects of this||
0464|117|P|drug, especially confusion.||
0464|118|P|   During pregnancy, this medication should be used only when||
0464|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
0464|120|P|   It is unknown if this medication passes into breast milk.||
0464|121|P|Consult your doctor before breastfeeding.||
0464|122|B|||
0464|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0464|124|I|medications work or increase your risk for serious side effects.||
0464|125|I|This document does not contain all possible drug interactions.||
0464|126|I|Keep a list of all the products you use (including||
0464|127|I|prescription/nonprescription drugs and herbal products) and share||
0464|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
0464|129|I|the dosage of any medicines without your doctor's approval.||
0464|130|I|   Tell your doctor or pharmacist if you are using other products||
0464|131|I|that cause drowsiness such as opioid pain or cough relievers||
0464|132|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
0464|133|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
0464|134|I|zolpidem), muscle relaxants (such as carisoprodol,||
0464|135|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0464|136|I|diphenhydramine).||
0464|137|I|   Check the labels on all your medicines (such as allergy or||
0464|138|I|cough-and-cold products) because they may contain ingredients||
0464|139|I|that cause drowsiness. Ask your pharmacist about using those||
0464|140|I|products safely.||
0464|141|B|||
0464|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0464|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0464|144|O|poison control center right away. US residents can call||
0464|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0464|146|B|||
0464|147|N|NOTES:  Do not share this medication with others.||
0464|148|N|   Lab and/or medical tests (such as CK levels) should be done||
0464|149|N|while you are using this medication. Keep all medical and lab||
0464|150|N|appointments. Consult your doctor for more details.||
0464|151|B|||
0464|152|D|MISSED DOSE:  If your dose is interrupted or stopped, contact||
0464|153|D|your doctor right away to establish a new dosing schedule.||
0464|154|B|||
0464|155|R|STORAGE:  Store in the refrigerator away from light. Do not||
0464|156|R|freeze. After being mixed with saline, it may be refrigerated for||
0464|157|R|up to 24 hours. Keep all medications away from children and pets.||
0464|158|R|   Do not flush medications down the toilet or pour them into a||
0464|159|R|drain unless instructed to do so. Properly discard this product||
0464|160|R|when it is expired or no longer needed. Consult your pharmacist||
0464|161|R|or local waste disposal company.||
0464|162|B|||
0464|163|A|Information last revised August 2024.||
0464|164|A|Copyright(c) 2025 First Databank, Inc.||
0464|165|B|||
0466|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0466|002|Z|does NOT have all possible information about this product. This||
0466|003|Z|information does not assure that this product is safe, effective,||
0466|004|Z|or appropriate for you. This information is not individual||
0466|005|Z|medical advice and does not substitute for the advice of your||
0466|006|Z|health care professional. Always ask your health care||
0466|007|Z|professional for complete information about this product and your||
0466|008|Z|specific health needs.||
0466|009|B|||
0466|010|T|ZOLPIDEM EXTENDED-RELEASE - ORAL||
0466|011|F|(ZOL-pi-dem)||
0466|012|B|||
0466|013|C|COMMON BRAND NAME(S): Ambien CR||
0466|014|B|||
0466|015|W|WARNING:  Rarely, after taking this drug, people have gotten out||
0466|016|W|of bed and driven vehicles while not fully awake||
0466|017|W|("sleep-driving"). People have also sleepwalked, prepared/eaten||
0466|018|W|food, made phone calls, or had sex while not fully awake. Often,||
0466|019|W|these people do not remember these events. This problem can be||
0466|020|W|dangerous (possibly fatal) to you or to others. If you find out||
0466|021|W|that you have done any of these activities after taking this||
0466|022|W|medication, tell your doctor right away. You should not take this||
0466|023|W|medication or similar medications (such as eszopiclone, zaleplon)||
0466|024|W|if you have this reaction to the medication.||
0466|025|B|||
0466|026|U|USES:  Zolpidem is used for a short time to treat a certain sleep||
0466|027|U|problem (insomnia) in adults. It helps you fall asleep faster and||
0466|028|U|stay asleep longer, so you can get a better night's sleep. It may||
0466|029|U|also reduce the number of times you wake up during the night.||
0466|030|U|Zolpidem belongs to a class of drugs called sedative-hypnotics.||
0466|031|U|It acts on your brain to produce a calming effect.||
0466|032|B|||
0466|033|H|HOW TO USE:  Read the Medication Guide provided by your||
0466|034|H|pharmacist before you start taking zolpidem and each time you get||
0466|035|H|a refill. If you have any questions, ask your doctor or||
0466|036|H|pharmacist.||
0466|037|H|   Take this medication by mouth on an empty stomach as directed||
0466|038|H|by your doctor, usually once a night. Since zolpidem works||
0466|039|H|quickly, take it right before you get into bed. Do not take it||
0466|040|H|with or after a meal because it will not work as quickly.||
0466|041|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
0466|042|H|Doing so can release all of the drug at once, increasing the risk||
0466|043|H|of side effects.||
0466|044|H|   Do not take a dose of this drug unless you have time for a||
0466|045|H|full night's sleep of at least 7 to 8 hours. If you have to wake||
0466|046|H|up before that, you may have some memory loss and may have||
0466|047|H|trouble safely doing anything that needs alertness, such as||
0466|048|H|driving or operating machinery. (See also Precautions section.)||
0466|049|H|   Dosage is based on your gender, age, medical condition, other||
0466|050|H|medications you may be taking, and response to treatment. Do not||
0466|051|H|increase your dose, take it more often, or use it for longer than||
0466|052|H|prescribed. Do not take more than 12.5 milligrams a day. Women||
0466|053|H|are usually prescribed a lower dose because the drug is removed||
0466|054|H|from the body more slowly than in men. Older adults are usually||
0466|055|H|prescribed a lower dose to decrease the risk of side effects.||
0466|056|H|   If you suddenly stop using this medication, you may have||
0466|057|H|withdrawal symptoms (such as nausea, vomiting, flushing, stomach||
0466|058|H|cramps, nervousness, shakiness). To help prevent withdrawal, your||
0466|059|H|doctor may lower your dose slowly. Withdrawal is more likely if||
0466|060|H|you have used zolpidem for a long time or in high doses. Tell||
0466|061|H|your doctor or pharmacist right away if you have withdrawal.||
0466|062|H|   Though it helps many people, this medication may sometimes||
0466|063|H|cause addiction. This risk may be higher if you have a substance||
0466|064|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0466|065|H|Take this medication exactly as prescribed to lower the risk of||
0466|066|H|addiction. Ask your doctor or pharmacist for more details.||
0466|067|H|   When this medication is used for a long time, it may not work||
0466|068|H|as well. Talk with your doctor if this medication stops working||
0466|069|H|well.||
0466|070|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
0466|071|H|or if it gets worse.||
0466|072|H|   You may have trouble sleeping the first few nights after you||
0466|073|H|stop taking this medication. This is called rebound insomnia and||
0466|074|H|is normal. It will usually go away after 1-2 nights. If this||
0466|075|H|effect continues, contact your doctor.||
0466|076|B|||
0466|077|S|SIDE EFFECTS:  See also Warning section.||
0466|078|S|   Dizziness may occur. If this effect lasts or gets worse, tell||
0466|079|S|your doctor or pharmacist promptly.||
0466|080|S|   This medication may make you sleepy during the day. Tell your||
0466|081|S|doctor if you have daytime drowsiness. Your dose may need to be||
0466|082|S|adjusted.||
0466|083|S|   Remember that this medication has been prescribed because your||
0466|084|S|doctor has judged that the benefit to you is greater than the||
0466|085|S|risk of side effects. Many people using this medication do not||
0466|086|S|have serious side effects.||
0466|087|S|   Tell your doctor right away if you have any serious side||
0466|088|S|effects, including: memory loss, mental/mood/behavior changes||
0466|089|S|(such as new/worsening depression, abnormal thoughts, thoughts of||
0466|090|S|suicide, hallucinations, confusion, agitation, aggressive||
0466|091|S|behavior, anxiety).||
0466|092|S|   A very serious allergic reaction to this drug is rare.||
0466|093|S|However, get medical help right away if you notice any symptoms||
0466|094|S|of a serious allergic reaction, including: rash, itching/swelling||
0466|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0466|096|S|breathing.||
0466|097|S|   This is not a complete list of possible side effects. If you||
0466|098|S|notice other effects not listed above, contact your doctor or||
0466|099|S|pharmacist.||
0466|100|S|   In the US -||
0466|101|S|   Call your doctor for medical advice about side effects. You||
0466|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0466|103|S|www.fda.gov/medwatch.||
0466|104|S|   In Canada - Call your doctor for medical advice about side||
0466|105|S|effects. You may report side effects to Health Canada at||
0466|106|S|1-866-234-2345.||
0466|107|B|||
0466|108|P|PRECAUTIONS:  See also Warning section.||
0466|109|P|   Before taking zolpidem, tell your doctor or pharmacist if you||
0466|110|P|are allergic to it; or if you have any other allergies. This||
0466|111|P|product may contain inactive ingredients, which can cause||
0466|112|P|allergic reactions or other problems. Talk to your pharmacist for||
0466|113|P|more details.||
0466|114|P|   Before using this medication, tell your doctor or pharmacist||
0466|115|P|your medical history, especially of: kidney disease, liver||
0466|116|P|disease, mental/mood problems (such as depression, thoughts of||
0466|117|P|suicide), personal or family history of a substance use disorder||
0466|118|P|(such as overuse of or addiction to drugs/alcohol), personal or||
0466|119|P|family history of sleepwalking, lung/breathing problems (such as||
0466|120|P|chronic obstructive pulmonary disease-COPD, sleep apnea), a||
0466|121|P|certain muscle disease (myasthenia gravis).||
0466|122|P|   Do not drive, use machinery, or do any activities that require||
0466|123|P|clear thinking after you take this medication and the next day.||
0466|124|P|You may feel alert, but this medication may continue to affect||
0466|125|P|your thinking, making such activities unsafe. This medication may||
0466|126|P|also increase the risk of falls. You may also experience||
0466|127|P|dizziness or blurred/double vision. Alcohol or marijuana||
0466|128|P|(cannabis) can make you more dizzy or drowsy. Do not drink||
0466|129|P|alcoholic beverages. Talk to your doctor if you are using||
0466|130|P|marijuana (cannabis).||
0466|131|P|   Before having surgery, tell your doctor or dentist about all||
0466|132|P|the products you use (including prescription drugs,||
0466|133|P|nonprescription drugs, and herbal products).||
0466|134|P|   Children may be more sensitive to the side effects of this||
0466|135|P|drug, especially dizziness and hallucinations.||
0466|136|P|   Older adults may be more sensitive to the side effects of this||
0466|137|P|drug, especially dizziness, confusion, unsteadiness, and||
0466|138|P|excessive drowsiness. These side effects can increase the risk of||
0466|139|P|falling.||
0466|140|P|   During pregnancy, this medication should be used only when||
0466|141|P|clearly needed. Babies born to mothers who have used this drug||
0466|142|P|late in the last 3 months of pregnancy may develop unusual||
0466|143|P|sleepiness, trouble breathing, unusual limpness, or withdrawal||
0466|144|P|symptoms. Get medical help right away if you notice any unusual||
0466|145|P|symptoms in your newborn. Discuss the risks and benefits with||
0466|146|P|your doctor.||
0466|147|P|   A small amount of this medication passes into breast milk and||
0466|148|P|may have undesirable effects on a nursing infant (such as unusual||
0466|149|P|sleepiness, trouble breathing, or unusual limpness). Get medical||
0466|150|P|help right away if you notice any unusual symptoms in your baby.||
0466|151|P|Ask your doctor if you should pump and discard your breast milk||
0466|152|P|during treatment and for 23 hours after a dose of this medication||
0466|153|P|to lessen the risk of these effects in your baby. Consult your||
0466|154|P|doctor before breastfeeding.||
0466|155|B|||
0466|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0466|157|I|medications work or increase your risk for serious side effects.||
0466|158|I|This document does not contain all possible drug interactions.||
0466|159|I|Keep a list of all the products you use (including||
0466|160|I|prescription/nonprescription drugs and herbal products) and share||
0466|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
0466|162|I|the dosage of any medicines without your doctor's approval.||
0466|163|I|   A product that may interact with this drug is: sodium oxybate.||
0466|164|I|   Other medications can affect the removal of zolpidem from your||
0466|165|I|body, which may affect how zolpidem works. Examples include azole||
0466|166|I|antifungals (such as ketoconazole), rifampin, St. John's Wort,||
0466|167|I|among others.||
0466|168|I|   The risk of serious side effects (such as slow/shallow||
0466|169|I|breathing, severe drowsiness/dizziness) may be increased if this||
0466|170|I|medication is taken with other products that may also cause||
0466|171|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0466|172|I|if you are taking other products such as opioid pain or cough||
0466|173|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0466|174|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0466|175|I|lorazepam, zopiclone), muscle relaxants (such as carisoprodol,||
0466|176|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0466|177|I|diphenhydramine).||
0466|178|I|   Check the labels on all your medicines (such as allergy or||
0466|179|I|cough-and-cold products) because they may contain ingredients||
0466|180|I|that cause drowsiness. Ask your pharmacist about using those||
0466|181|I|products safely.||
0466|182|B|||
0466|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0466|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0466|185|O|poison control center right away. US residents can call||
0466|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0466|187|O|Symptoms of overdose may include slowed breathing or a deep sleep||
0466|188|O|from which you cannot be awakened.||
0466|189|B|||
0466|190|N|NOTES:  Do not share this medication with others. Sharing it is||
0466|191|N|against the law.||
0466|192|N|   As you get older, your sleep pattern may naturally change and||
0466|193|N|your sleep may be interrupted several times during the night.||
0466|194|N|Consult your doctor or pharmacist for ways to improve your sleep||
0466|195|N|without medication, such as avoiding caffeine and alcohol close||
0466|196|N|to bedtime, avoiding daytime naps, and going to bed at the same||
0466|197|N|time each night.||
0466|198|B|||
0466|199|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
0466|200|D|time to sleep for 7 to 8 hours afterwards.||
0466|201|B|||
0466|202|R|STORAGE:  Store at room temperature away from light and moisture.||
0466|203|R|Do not store in the bathroom. Keep all medications away from||
0466|204|R|children and pets.||
0466|205|R|   Do not flush medications down the toilet or pour them into a||
0466|206|R|drain unless instructed to do so. Properly discard this product||
0466|207|R|when it is expired or no longer needed. Consult your pharmacist||
0466|208|R|or local waste disposal company.||
0466|209|B|||
0466|210|A|Information last revised May 2024.||
0466|211|A|Copyright(c) 2025 First Databank, Inc.||
0466|212|B|||
0470|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0470|002|Z|does NOT have all possible information about this product. This||
0470|003|Z|information does not assure that this product is safe, effective,||
0470|004|Z|or appropriate for you. This information is not individual||
0470|005|Z|medical advice and does not substitute for the advice of your||
0470|006|Z|health care professional. Always ask your health care||
0470|007|Z|professional for complete information about this product and your||
0470|008|Z|specific health needs.||
0470|009|B|||
0470|010|T|MYCOPHENOLATE SODIUM DELAYED-RELEASE TABLET - ORAL||
0470|011|F|(MYE-koe-FEN-oh-late SOE-dee-um)||
0470|012|B|||
0470|013|C|COMMON BRAND NAME(S): Myfortic||
0470|014|B|||
0470|015|W|WARNING:  Mycophenolate may lower your ability to fight||
0470|016|W|infections. This may make you more likely to get a serious||
0470|017|W|(rarely fatal) infection or make any infection you have worse.||
0470|018|W|Tell your doctor right away if you have any signs of infection||
0470|019|W|(such as sore throat that doesn't go away, fever, chills,||
0470|020|W|burning/painful/urgent urination, change in the amount of urine).||
0470|021|W|   Mycophenolate may rarely cause cancer (such as lymphoma, skin||
0470|022|W|cancer). Protect your skin from the sun. Avoid prolonged sun||
0470|023|W|exposure, tanning booths, and sunlamps. Use a sunscreen and wear||
0470|024|W|protective clothing when outdoors. Tell your doctor right away if||
0470|025|W|you have any of the following symptoms of cancer: swollen lymph||
0470|026|W|nodes, sudden weight loss, night sweats, change in appearance or||
0470|027|W|size of moles, or unusual skin changes/growth.||
0470|028|W|   Mycophenolate may harm an unborn baby. When using||
0470|029|W|mycophenolate, men and women must use reliable forms of birth||
0470|030|W|control. See also Precautions section.||
0470|031|B|||
0470|032|U|USES:  Mycophenolate is used in combination with other||
0470|033|U|medications to keep your body from attacking and rejecting your||
0470|034|U|transplanted kidney. It belongs to a class of medications called||
0470|035|U|immunosuppressants. It works by weakening your body's defense||
0470|036|U|system (immune system) to help your body accept the new kidney as||
0470|037|U|if it were your own.||
0470|038|B|||
0470|039|H|HOW TO USE:  Read the Medication Guide provided by your||
0470|040|H|pharmacist before you start taking mycophenolate and each time||
0470|041|H|you get a refill. If you have any questions, ask your doctor or||
0470|042|H|pharmacist.||
0470|043|H|   Take this medication by mouth as directed by your doctor,||
0470|044|H|usually twice daily on an empty stomach, 1 hour before or 2 hours||
0470|045|H|after meals.||
0470|046|H|   Swallow the tablet whole. Do not crush, chew, or break the||
0470|047|H|tablet. Doing so may prevent your body from fully absorbing the||
0470|048|H|drug.||
0470|049|H|   Avoid handling or inhaling any dust from the tablets. Avoid||
0470|050|H|direct contact with the skin or eyes. If contact occurs, wash the||
0470|051|H|affected skin area well with soap and water or rinse your eyes||
0470|052|H|with plain water. Consult your pharmacist for details.||
0470|053|H|   Since this drug can be absorbed through the skin and lungs and||
0470|054|H|may harm an unborn baby, women who are pregnant or who may become||
0470|055|H|pregnant should not handle this medication or breathe the dust||
0470|056|H|from the tablets.||
0470|057|H|   The dosage is based on your medical condition and response to||
0470|058|H|treatment. Children's dosage is also based on body size.||
0470|059|H|   Use this medication regularly to get the most benefit from it.||
0470|060|H|To help you remember, take it at the same times each day.||
0470|061|H|   Keep taking this medication even if you feel well. Do not stop||
0470|062|H|taking mycophenolate without first talking to your doctor.||
0470|063|H|   Certain products may make it harder for your body to absorb||
0470|064|H|mycophenolate if they are taken at the same time. Do not take||
0470|065|H|this medication at the same time as antacids containing aluminum||
0470|066|H|and/or magnesium, cholestyramine, colestipol, or calcium-free||
0470|067|H|phosphate binders (such as aluminum products, lanthanum,||
0470|068|H|sevelamer). Ask your pharmacist for more details.||
0470|069|H|   Do not change brands or forms of mycophenolate unless directed||
0470|070|H|by your doctor.||
0470|071|B|||
0470|072|S|SIDE EFFECTS:  See also Warning section.||
0470|073|S|   Constipation, nausea, headache, diarrhea, vomiting, stomach||
0470|074|S|upset, gas, tremor, dizziness, drowsiness, or trouble sleeping||
0470|075|S|may occur. If any of these effects last or get worse, tell your||
0470|076|S|doctor or pharmacist promptly.||
0470|077|S|   Remember that this medication has been prescribed because your||
0470|078|S|doctor has judged that the benefit to you is greater than the||
0470|079|S|risk of side effects. Many people using this medication do not||
0470|080|S|have serious side effects.||
0470|081|S|   Tell your doctor right away if you have any serious side||
0470|082|S|effects, including: unusual tiredness, fast/irregular heartbeat,||
0470|083|S|easy bleeding/bruising, swelling of the feet or ankles, joint||
0470|084|S|pain/stiffness, muscle pain.||
0470|085|S|   Get medical help right away if you have any very serious side||
0470|086|S|effects, including: stomach/abdominal pain that doesn't go away,||
0470|087|S|black stools, vomit that looks like coffee grounds, chest pain,||
0470|088|S|shortness of breath/rapid breathing.||
0470|089|S|   This medication may increase your risk of getting a rare but||
0470|090|S|very serious (possibly fatal) brain infection (progressive||
0470|091|S|multifocal leukoencephalopathy-PML). Get medical help right away||
0470|092|S|if you have any of these side effects: clumsiness, loss of||
0470|093|S|coordination/balance, weakness, sudden change in your thinking||
0470|094|S|(such as confusion, difficulty concentrating, memory loss),||
0470|095|S|difficulty talking/walking, seizure, vision changes.||
0470|096|S|   A very serious allergic reaction to this drug is rare.||
0470|097|S|However, get medical help right away if you notice any symptoms||
0470|098|S|of a serious allergic reaction, including: rash, itching/swelling||
0470|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0470|100|S|breathing.||
0470|101|S|   This is not a complete list of possible side effects. If you||
0470|102|S|notice other effects not listed above, contact your doctor or||
0470|103|S|pharmacist.||
0470|104|S|   In the US -||
0470|105|S|   Call your doctor for medical advice about side effects. You||
0470|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0470|107|S|www.fda.gov/medwatch.||
0470|108|S|   In Canada - Call your doctor for medical advice about side||
0470|109|S|effects. You may report side effects to Health Canada at||
0470|110|S|1-866-234-2345.||
0470|111|B|||
0470|112|P|PRECAUTIONS:  See also Warning section.||
0470|113|P|   Before taking mycophenolate sodium, tell your doctor or||
0470|114|P|pharmacist if you are allergic to it; or to mycophenolic acid; or||
0470|115|P|to mycophenolate mofetil; or if you have any other allergies.||
0470|116|P|This product may contain inactive ingredients, which can cause||
0470|117|P|allergic reactions or other problems. Talk to your pharmacist for||
0470|118|P|more details.||
0470|119|P|   Before using this medication, tell your doctor or pharmacist||
0470|120|P|your medical history, especially of: cancer, liver disease (such||
0470|121|P|as hepatitis B, hepatitis C), current/past infections (such as||
0470|122|P|herpes, shingles), stomach/intestinal problems (such as ulcers),||
0470|123|P|rare genetic disorders (such as Lesch-Nyhan or Kelley-Seegmiller||
0470|124|P|syndromes).||
0470|125|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0470|126|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0470|127|P|machinery, or do anything that needs alertness until you can do||
0470|128|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0470|129|P|are using marijuana (cannabis).||
0470|130|P|   Mycophenolate can make you more likely to get infections or||
0470|131|P|may make current infections worse. Stay away from anyone who has||
0470|132|P|an infection that may easily spread (such as chickenpox,||
0470|133|P|COVID-19, measles, flu). Talk to your doctor if you have been||
0470|134|P|exposed to an infection or for more details.||
0470|135|P|   Tell your health care professional that you are using||
0470|136|P|mycophenolate sodium before having any||
0470|137|P|immunizations/vaccinations. Avoid contact with people who have||
0470|138|P|recently received live vaccines (such as flu vaccine inhaled||
0470|139|P|through the nose).||
0470|140|P|   To lower the chance of getting cut, bruised, or injured, use||
0470|141|P|caution with sharp objects like razors and nail cutters, and||
0470|142|P|avoid activities such as contact sports.||
0470|143|P|   Before having surgery, tell your doctor or dentist about all||
0470|144|P|the products you use (including prescription drugs,||
0470|145|P|nonprescription drugs, and herbal products).||
0470|146|P|   Do not donate blood while using mycophenolate and for 6 weeks||
0470|147|P|after stopping this drug. Do not donate sperm while using||
0470|148|P|mycophenolate and for 90 days after stopping this drug.||
0470|149|P|   Since this drug can be absorbed through the skin and lungs and||
0470|150|P|may harm an unborn baby, women who are pregnant or who may become||
0470|151|P|pregnant should not handle this medication or breathe the dust||
0470|152|P|from the tablets.||
0470|153|P|   Tell your doctor if you are pregnant or plan to become||
0470|154|P|pregnant. You should not become pregnant while using||
0470|155|P|mycophenolate. Mycophenolate may harm an unborn baby. Your doctor||
0470|156|P|should order a pregnancy test before you start this medication.||
0470|157|P|Women using this medication should ask about reliable forms of||
0470|158|P|birth control during treatment and for 6 weeks after the last||
0470|159|P|dose. Men using this medication should ask about reliable forms||
0470|160|P|of birth control during treatment and for 3 months after the last||
0470|161|P|dose. If you or your partner becomes pregnant, talk to your||
0470|162|P|doctor right away about the risks and benefits of this||
0470|163|P|medication.||
0470|164|P|   It is unknown if this drug passes into breast milk. Because of||
0470|165|P|the possible risk to the infant, breastfeeding is not recommended||
0470|166|P|while using this drug. Consult your doctor before breastfeeding.||
0470|167|B|||
0470|168|I|DRUG INTERACTIONS:  See also How to Use section.||
0470|169|I|   Drug interactions may change how your medications work or||
0470|170|I|increase your risk for serious side effects. This document does||
0470|171|I|not contain all possible drug interactions. Keep a list of all||
0470|172|I|the products you use (including prescription/nonprescription||
0470|173|I|drugs and herbal products) and share it with your doctor and||
0470|174|I|pharmacist. Do not start, stop, or change the dosage of any||
0470|175|I|medicines without your doctor's approval.||
0470|176|I|   Some products that may interact with this drug include: other||
0470|177|I|drugs that weaken the immune system/increase the risk of||
0470|178|I|infection (such as natalizumab, rituximab).||
0470|179|I|   This medication may decrease the effectiveness of hormonal||
0470|180|I|birth control such as pills, patch, or ring. This could cause||
0470|181|I|pregnancy. Discuss with your doctor or pharmacist about using a||
0470|182|I|reliable backup birth control method while using this medication.||
0470|183|I|Also tell your doctor if you have any new spotting or||
0470|184|I|breakthrough bleeding, because these may be signs that your birth||
0470|185|I|control is not working well.||
0470|186|B|||
0470|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0470|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0470|189|O|poison control center right away. US residents can call||
0470|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0470|191|B|||
0470|192|N|NOTES:  Do not share this medication with others.||
0470|193|N|   Lab and/or medical tests (such as blood counts, drug levels,||
0470|194|N|kidney function, pregnancy test) should be done while you are||
0470|195|N|taking this medication. Keep all medical and lab appointments.||
0470|196|N|Consult your doctor for more details.||
0470|197|N|   Attend a transplant education class or support group to learn||
0470|198|N|more about the signs and symptoms of kidney rejection. Tell your||
0470|199|N|doctor right away if you have any of the following symptoms:||
0470|200|N|decreased amount of urine, fever, tenderness at the transplant||
0470|201|N|site, or weight gain of more than 2 pounds in a day with possible||
0470|202|N|swelling of the ankles.||
0470|203|B|||
0470|204|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0470|205|D|remember. If it is near the time of the next dose, skip the||
0470|206|D|missed dose. Take your next dose at the regular time. Do not||
0470|207|D|double the dose to catch up.||
0470|208|B|||
0470|209|R|STORAGE:  Store at room temperature away from light and moisture.||
0470|210|R|Do not store in the bathroom. Keep all medications away from||
0470|211|R|children and pets.||
0470|212|R|   Do not flush medications down the toilet or pour them into a||
0470|213|R|drain unless instructed to do so. Properly discard this product||
0470|214|R|when it is expired or no longer needed. Consult your pharmacist||
0470|215|R|or local waste disposal company.||
0470|216|B|||
0470|217|M|MEDICAL ALERT:  Your condition can cause complications in a||
0470|218|M|medical emergency. For information about enrolling in MedicAlert,||
0470|219|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0470|220|B|||
0470|221|A|Information last revised May 2025.||
0470|222|A|Copyright(c) 2025 First Databank, Inc.||
0470|223|B|||
0471|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0471|002|Z|does NOT have all possible information about this product. This||
0471|003|Z|information does not assure that this product is safe, effective,||
0471|004|Z|or appropriate for you. This information is not individual||
0471|005|Z|medical advice and does not substitute for the advice of your||
0471|006|Z|health care professional. Always ask your health care||
0471|007|Z|professional for complete information about this product and your||
0471|008|Z|specific health needs.||
0471|009|B|||
0471|010|T|CEFPROZIL SUSPENSION - ORAL||
0471|011|F|(sef-PROE-zil)||
0471|012|B|||
0471|013|C|COMMON BRAND NAME(S): Cefzil||
0471|014|B|||
0471|015|U|USES:  Cefprozil is used to treat a wide variety of bacterial||
0471|016|U|infections. This medication is known as a cephalosporin||
0471|017|U|antibiotic. It works by stopping the growth of bacteria.||
0471|018|U|   This antibiotic treats only bacterial infections. It will not||
0471|019|U|work for viral infections (such as common cold, flu). Using any||
0471|020|U|antibiotic when it is not needed can cause it to not work for||
0471|021|U|future infections.||
0471|022|B|||
0471|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
0471|024|H|doctor, usually once or twice daily. You may take this medicine||
0471|025|H|with food if stomach upset occurs. Shake the bottle well before||
0471|026|H|each dose. Carefully measure the dose using a special measuring||
0471|027|H|device/spoon. Do not use a household spoon because you may not||
0471|028|H|get the correct dose.||
0471|029|H|   The dosage is based on your medical condition and response to||
0471|030|H|treatment. Children's dosage is also based on weight.||
0471|031|H|   For the best effect, take this antibiotic at evenly spaced||
0471|032|H|times. To help you remember, take this medication at the same||
0471|033|H|time(s) every day.||
0471|034|H|   Continue to take this medication until the full prescribed||
0471|035|H|amount is finished, even if symptoms disappear after a few days.||
0471|036|H|Stopping the medication too early may result in a return of the||
0471|037|H|infection.||
0471|038|H|   Tell your doctor if your condition lasts or gets worse.||
0471|039|B|||
0471|040|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach pain, or||
0471|041|S|dizziness may occur. Diaper rash may occur in young children. If||
0471|042|S|any of these effects last or get worse, notify your doctor or||
0471|043|S|pharmacist promptly.||
0471|044|S|   Remember that this medication has been prescribed because your||
0471|045|S|doctor has judged that the benefit to you is greater than the||
0471|046|S|risk of side effects. Many people using this medication do not||
0471|047|S|have serious side effects.||
0471|048|S|   Tell your doctor right away if you have any serious side||
0471|049|S|effects, including: nausea/vomiting that doesn't stop, unusual||
0471|050|S|tiredness/weakness, yellowing of the eyes/skin, severe||
0471|051|S|stomach/abdominal pain, dark urine, signs of kidney problems||
0471|052|S|(such as change in the amount of urine), signs of new infection||
0471|053|S|(such as sore throat that doesn't go away, fever), easy||
0471|054|S|bruising/bleeding, mental/mood changes (such as confusion).||
0471|055|S|   This medication may rarely cause a severe intestinal condition||
0471|056|S|due to a bacteria called C. difficile. This condition may occur||
0471|057|S|during treatment or weeks to months after treatment has stopped.||
0471|058|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0471|059|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0471|060|S|stool.||
0471|061|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0471|062|S|products because they may make symptoms worse.||
0471|063|S|   Use of this medication for prolonged or repeated periods may||
0471|064|S|result in oral thrush or a new vaginal yeast infection (oral or||
0471|065|S|vaginal fungal infection). Contact your doctor if you notice||
0471|066|S|white patches in your mouth, a change in vaginal discharge or||
0471|067|S|other new symptoms.||
0471|068|S|   A very serious allergic reaction to this drug is rare.||
0471|069|S|However, get medical help right away if you notice any symptoms||
0471|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0471|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0471|072|S|breathing.||
0471|073|S|   This is not a complete list of possible side effects. If you||
0471|074|S|notice other effects not listed above, contact your doctor or||
0471|075|S|pharmacist.||
0471|076|S|   In the US -||
0471|077|S|   Call your doctor for medical advice about side effects. You||
0471|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0471|079|S|www.fda.gov/medwatch.||
0471|080|S|   In Canada - Call your doctor for medical advice about side||
0471|081|S|effects. You may report side effects to Health Canada at||
0471|082|S|1-866-234-2345.||
0471|083|B|||
0471|084|P|PRECAUTIONS:  Before taking cefprozil, tell your doctor or||
0471|085|P|pharmacist if you are allergic to it; or to penicillins or other||
0471|086|P|cephalosporin antibiotics (such as cephalexin); or if you have||
0471|087|P|any other allergies. This product may contain inactive||
0471|088|P|ingredients, which can cause allergic reactions or other||
0471|089|P|problems. Talk to your pharmacist for more details.||
0471|090|P|   Before using this medication, tell your doctor or pharmacist||
0471|091|P|your medical history, especially of: kidney disease, intestinal||
0471|092|P|disease (colitis).||
0471|093|P|   This medicine may contain aspartame. If you have||
0471|094|P|phenylketonuria (PKU) or any other condition where you must||
0471|095|P|restrict your intake of aspartame (or phenylalanine), consult||
0471|096|P|your doctor or pharmacist regarding the safe use of this||
0471|097|P|medicine.||
0471|098|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0471|099|P|can make you more dizzy. Do not drive, use machinery, or do||
0471|100|P|anything that needs alertness until you can do it safely. Limit||
0471|101|P|alcoholic beverages. Talk to your doctor if you are using||
0471|102|P|marijuana (cannabis).||
0471|103|P|   Cefprozil may cause live bacterial vaccines (such as typhoid||
0471|104|P|vaccine) to not work well. Tell your health care professional||
0471|105|P|that you are using cefprozil before having any||
0471|106|P|immunizations/vaccinations.||
0471|107|P|   Older adults may be more sensitive to the side effects of this||
0471|108|P|drug.||
0471|109|P|   Children may be more sensitive to the side effects of this||
0471|110|P|drug, especially rash.||
0471|111|P|   During pregnancy, this medication should be used only when||
0471|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
0471|113|P|   This medication passes into breast milk. Consult your doctor||
0471|114|P|before breastfeeding.||
0471|115|B|||
0471|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0471|117|I|medications work or increase your risk for serious side effects.||
0471|118|I|This document does not contain all possible drug interactions.||
0471|119|I|Keep a list of all the products you use (including||
0471|120|I|prescription/nonprescription drugs and herbal products) and share||
0471|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
0471|122|I|the dosage of any medicines without your doctor's approval.||
0471|123|I|   This medication may interfere with certain lab tests (such as||
0471|124|I|certain diabetic urine tests, blood glucose tests), possibly||
0471|125|I|causing false test results. Make sure lab personnel and all your||
0471|126|I|doctors know you use this drug.||
0471|127|B|||
0471|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0471|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0471|130|O|poison control center right away. US residents can call||
0471|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0471|132|O|Symptoms of overdose may include seizures.||
0471|133|B|||
0471|134|N|NOTES:  Do not share this medication with others.||
0471|135|N|   This medication has been prescribed for your current condition||
0471|136|N|only. Do not use it later for another infection unless your||
0471|137|N|doctor tells you to.||
0471|138|B|||
0471|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0471|140|D|remember. If it is near the time of the next dose, skip the||
0471|141|D|missed dose. Take your next dose at the regular time. Do not||
0471|142|D|double the dose to catch up.||
0471|143|B|||
0471|144|R|STORAGE:  Refrigerate the suspension. Do not freeze. Discard any||
0471|145|R|unused medication after 14 days. Keep all medications away from||
0471|146|R|children and pets.||
0471|147|R|   Do not flush medications down the toilet or pour them into a||
0471|148|R|drain unless instructed to do so. Properly discard this product||
0471|149|R|when it is expired or no longer needed. Consult your pharmacist||
0471|150|R|or local waste disposal company.||
0471|151|B|||
0471|152|A|Information last revised August 2024.||
0471|153|A|Copyright(c) 2025 First Databank, Inc.||
0471|154|B|||
0472|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0472|002|Z|does NOT have all possible information about this product. This||
0472|003|Z|information does not assure that this product is safe, effective,||
0472|004|Z|or appropriate for you. This information is not individual||
0472|005|Z|medical advice and does not substitute for the advice of your||
0472|006|Z|health care professional. Always ask your health care||
0472|007|Z|professional for complete information about this product and your||
0472|008|Z|specific health needs.||
0472|009|B|||
0472|010|T|ALBUTEROL (SALBUTAMOL) - ORAL||
0472|011|F|(al-BUE-ter-ol/sal-BUE-ta-mol)||
0472|012|B|||
0472|013|C|COMMON BRAND NAME(S): Proventil||
0472|014|B|||
0472|015|U|USES:  Albuterol (also known as salbutamol) is used to treat||
0472|016|U|wheezing and shortness of breath caused by breathing problems||
0472|017|U|(such as asthma, chronic obstructive pulmonary disease).||
0472|018|U|Albuterol belongs to a class of drugs known as bronchodilators.||
0472|019|U|It works by relaxing the muscles around the airways so that they||
0472|020|U|open up and you can breathe more easily. Controlling symptoms of||
0472|021|U|breathing problems can decrease time lost from work or school.||
0472|022|U|   This medication is taken by mouth and does not work right||
0472|023|U|away. It should not be used for sudden attacks of breathing||
0472|024|U|trouble. Your doctor may prescribe a quick-relief inhaler for||
0472|025|U|sudden shortness of breath/asthma attacks while you are on this||
0472|026|U|medication. Always have the quick-relief inhaler with you.||
0472|027|U|Consult your doctor or pharmacist for more details.||
0472|028|B|||
0472|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
0472|030|H|doctor, usually 3 or 4 times daily. The dosage is based on your||
0472|031|H|medical condition and response to treatment.||
0472|032|H|   Use this medication regularly to get the most benefit from it.||
0472|033|H|To help you remember, take it at the same times each day. Do not||
0472|034|H|increase your dose or take this drug more often than prescribed||
0472|035|H|because your risk of serious side effects will increase.||
0472|036|H|   Learn which of your medications you should use every day and||
0472|037|H|which you should use if your breathing suddenly worsens. Ask your||
0472|038|H|doctor what to do if you have worsening cough or shortness of||
0472|039|H|breath, wheezing, increased sputum, worsening peak flow meter||
0472|040|H|readings, increased use of your quick-relief inhaler, or if your||
0472|041|H|quick-relief inhaler does not seem to be working well. Learn when||
0472|042|H|you can self-medicate and when you should get medical help right||
0472|043|H|away.||
0472|044|B|||
0472|045|S|SIDE EFFECTS:  Nervousness, shaking (tremor), headache, or||
0472|046|S|dizziness may occur. If any of these effects last or get worse,||
0472|047|S|tell your doctor or pharmacist promptly.||
0472|048|S|   Remember that this medication has been prescribed because your||
0472|049|S|doctor has judged that the benefit to you is greater than the||
0472|050|S|risk of side effects. Many people using this medication do not||
0472|051|S|have serious side effects.||
0472|052|S|   This medication may raise your blood pressure. Check your||
0472|053|S|blood pressure regularly and tell your doctor if the results are||
0472|054|S|high.||
0472|055|S|   Tell your doctor right away if you have any serious side||
0472|056|S|effects, including: fast/pounding heartbeat.||
0472|057|S|   Get medical help right away if you have any very serious side||
0472|058|S|effects, including: chest pain, irregular heartbeat.||
0472|059|S|   Rarely, this medication has caused severe (rarely fatal),||
0472|060|S|sudden worsening of breathing problems/asthma (paradoxical||
0472|061|S|bronchospasm). If you experience sudden wheezing, get medical||
0472|062|S|help right away.||
0472|063|S|   A very serious allergic reaction to this drug is rare.||
0472|064|S|However, get medical help right away if you notice any symptoms||
0472|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0472|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0472|067|S|breathing.||
0472|068|S|   This is not a complete list of possible side effects. If you||
0472|069|S|notice other effects not listed above, contact your doctor or||
0472|070|S|pharmacist.||
0472|071|S|   In the US -||
0472|072|S|   Call your doctor for medical advice about side effects. You||
0472|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0472|074|S|www.fda.gov/medwatch.||
0472|075|S|   In Canada - Call your doctor for medical advice about side||
0472|076|S|effects. You may report side effects to Health Canada at||
0472|077|S|1-866-234-2345.||
0472|078|B|||
0472|079|P|PRECAUTIONS:  Before taking albuterol, tell your doctor or||
0472|080|P|pharmacist if you are allergic to it; or if you have had a||
0472|081|P|serious reaction to similar drugs (such as levalbuterol,||
0472|082|P|metaproterenol, terbutaline); or if you have any other allergies.||
0472|083|P|This product may contain inactive ingredients, which can cause||
0472|084|P|allergic reactions or other problems. Talk to your pharmacist for||
0472|085|P|more details.||
0472|086|P|   Before using this medication, tell your doctor or pharmacist||
0472|087|P|your medical history, especially of: heart problems (such as||
0472|088|P|irregular heartbeat, angina, heart attack), high blood pressure,||
0472|089|P|diabetes, seizure.||
0472|090|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0472|091|P|can make you more dizzy. Do not drive, use machinery, or do||
0472|092|P|anything that needs alertness until you can do it safely. Limit||
0472|093|P|alcoholic beverages. Talk to your doctor if you are using||
0472|094|P|marijuana (cannabis).||
0472|095|P|   Before having surgery, tell your doctor or dentist about all||
0472|096|P|the products you use (including prescription drugs,||
0472|097|P|nonprescription drugs, and herbal products).||
0472|098|P|   During pregnancy, this medication should be used only when||
0472|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
0472|100|P|   It is unknown if this medication passes into breast milk.||
0472|101|P|Consult your doctor before breastfeeding.||
0472|102|B|||
0472|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0472|104|I|medications work or increase your risk for serious side effects.||
0472|105|I|This document does not contain all possible drug interactions.||
0472|106|I|Keep a list of all the products you use (including||
0472|107|I|prescription/nonprescription drugs and herbal products) and share||
0472|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
0472|109|I|the dosage of any medicines without your doctor's approval.||
0472|110|B|||
0472|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0472|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0472|113|O|poison control center right away. US residents can call||
0472|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0472|115|O|Symptoms of overdose may include: fast/pounding/irregular||
0472|116|O|heartbeat, severe shaking (tremors), seizures, chest pain.||
0472|117|B|||
0472|118|N|NOTES:  Do not share this medication with others.||
0472|119|N|   Lab and/or medical tests (such as lung function, blood||
0472|120|N|pressure) should be done while you are taking this medication.||
0472|121|N|Keep all medical and lab appointments. Consult your doctor for||
0472|122|N|more details.||
0472|123|N|   Avoid allergens/irritants such as smoke, pollen, pet dander,||
0472|124|N|dust, or molds that may worsen breathing problems.||
0472|125|N|   Learn to use a peak flow meter, use it daily, and promptly||
0472|126|N|report worsening breathing problems (such as readings in the||
0472|127|N|yellow/red range, increased use of quick-relief inhalers).||
0472|128|N|   Ask your doctor or pharmacist whether you should have an||
0472|129|N|annual flu shot.||
0472|130|B|||
0472|131|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0472|132|D|remember. If it is near the time of the next dose, skip the||
0472|133|D|missed dose. Take your next dose at the regular time. Do not||
0472|134|D|double the dose to catch up.||
0472|135|B|||
0472|136|R|STORAGE:  Store at room temperature away from light and moisture.||
0472|137|R|Do not store in the bathroom. Keep all medications away from||
0472|138|R|children and pets.||
0472|139|R|   Do not flush medications down the toilet or pour them into a||
0472|140|R|drain unless instructed to do so. Properly discard this product||
0472|141|R|when it is expired or no longer needed. Consult your pharmacist||
0472|142|R|or local waste disposal company.||
0472|143|B|||
0472|144|M|MEDICAL ALERT:  Your condition can cause complications in a||
0472|145|M|medical emergency. For information about enrolling in MedicAlert,||
0472|146|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0472|147|B|||
0472|148|A|Information last revised May 2024.||
0472|149|A|Copyright(c) 2025 First Databank, Inc.||
0472|150|B|||
0473|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0473|002|Z|does NOT have all possible information about this product. This||
0473|003|Z|information does not assure that this product is safe, effective,||
0473|004|Z|or appropriate for you. This information is not individual||
0473|005|Z|medical advice and does not substitute for the advice of your||
0473|006|Z|health care professional. Always ask your health care||
0473|007|Z|professional for complete information about this product and your||
0473|008|Z|specific health needs.||
0473|009|B|||
0473|010|T|PREDNICARBATE CREAM - TOPICAL||
0473|011|F|(PRED-ni-KAR-bate)||
0473|012|B|||
0473|013|C|COMMON BRAND NAME(S): Dermatop||
0473|014|B|||
0473|015|U|USES:  This medication is used to treat a variety of skin||
0473|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0473|017|U|Prednicarbate reduces the swelling, itching and redness that can||
0473|018|U|occur in these types of conditions. This medication is a||
0473|019|U|medium-strength corticosteroid.||
0473|020|B|||
0473|021|H|HOW TO USE:  Use this medication on the skin only. Do not use it||
0473|022|H|on the face, groin, underarms, inside the vagina, or for diaper||
0473|023|H|rash, unless directed to do so by your doctor.||
0473|024|H|   Wash and dry your hands before using. Clean and dry the||
0473|025|H|affected area. Apply a thin film of medication to the affected||
0473|026|H|area and gently rub in as directed by your doctor, usually twice||
0473|027|H|daily. Do not bandage, cover or wrap the area unless directed to||
0473|028|H|do so by your doctor.||
0473|029|H|   After applying the medication, wash your hands, unless you are||
0473|030|H|using this medication to treat the hands. When applying this||
0473|031|H|medication near the eyes, avoid getting it in the eyes because||
0473|032|H|this may worsen or cause glaucoma. Also, avoid getting this||
0473|033|H|medication in the nose or mouth. If you get the medication in||
0473|034|H|your eyes, nose, or mouth, rinse with plenty of water.||
0473|035|H|   Use this medication only for the condition prescribed. Do not||
0473|036|H|use it on a child for longer than 3 weeks in a row, unless||
0473|037|H|directed to do so by your doctor.||
0473|038|H|   Tell your doctor if your condition lasts or gets worse after 2||
0473|039|H|weeks.||
0473|040|B|||
0473|041|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
0473|042|S|or redness of the skin may occur when first applied to the skin.||
0473|043|S|This should disappear in a few days as your body adjusts to the||
0473|044|S|medication. If any of these effects last or get worse, notify||
0473|045|S|your doctor or pharmacist promptly.||
0473|046|S|   Remember that this medication has been prescribed because your||
0473|047|S|doctor has judged that the benefit to you is greater than the||
0473|048|S|risk of side effects. Many people using this medication do not||
0473|049|S|have serious side effects.||
0473|050|S|   Tell your doctor right away if you have any serious side||
0473|051|S|effects, including: stretch marks, skin thinning/discoloration,||
0473|052|S|acne, excessive hair growth, small red bumps on the skin||
0473|053|S|(folliculitis).||
0473|054|S|   Skin infections can become worse when using this medication.||
0473|055|S|Notify your doctor promptly if redness, swelling or irritation||
0473|056|S|does not improve.||
0473|057|S|   Rarely, it is possible this medication will be absorbed from||
0473|058|S|the skin into the bloodstream. This can lead to side effects of||
0473|059|S|too much corticosteroid. These side effects are more likely in||
0473|060|S|children, and in people who use this medication for a long time||
0473|061|S|or over large areas of the skin. Tell your doctor right away if||
0473|062|S|any of the following side effects occur: unusual/extreme||
0473|063|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0473|064|S|thirst/urination, vision problems.||
0473|065|S|   A very serious allergic reaction to this drug is rare.||
0473|066|S|However, get medical help right away if you notice any symptoms||
0473|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0473|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0473|069|S|breathing.||
0473|070|S|   This is not a complete list of possible side effects. If you||
0473|071|S|notice other effects not listed above, contact your doctor or||
0473|072|S|pharmacist.||
0473|073|S|   In the US -||
0473|074|S|   Call your doctor for medical advice about side effects. You||
0473|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0473|076|S|www.fda.gov/medwatch.||
0473|077|S|   In Canada - Call your doctor for medical advice about side||
0473|078|S|effects. You may report side effects to Health Canada at||
0473|079|S|1-866-234-2345.||
0473|080|B|||
0473|081|P|PRECAUTIONS:  Before using prednicarbate, tell your doctor or||
0473|082|P|pharmacist if you are allergic to it; or to other corticosteroids||
0473|083|P|(such as hydrocortisone, prednisone); or if you have any other||
0473|084|P|allergies. This product may contain inactive ingredients, which||
0473|085|P|can cause allergic reactions or other problems. Talk to your||
0473|086|P|pharmacist for more details.||
0473|087|P|   Before using this medication, tell your doctor or pharmacist||
0473|088|P|your medical history, especially of: poor blood circulation,||
0473|089|P|diabetes, immune system problems, other skin conditions (such as||
0473|090|P|rosacea, perioral dermatitis).||
0473|091|P|   Do not use if there is an infection or sore in the area to be||
0473|092|P|treated.||
0473|093|P|   This medication may reduce the effectiveness of||
0473|094|P|latex-containing products (such as condoms).||
0473|095|P|   Rarely, using corticosteroid medications for a long time or||
0473|096|P|over large areas of skin can make it more difficult for your body||
0473|097|P|to respond to physical stress. Before having surgery or emergency||
0473|098|P|treatment, or if you get a serious illness/injury, tell your||
0473|099|P|doctor or dentist that you are using this medication or have used||
0473|100|P|this medication within the past few months.||
0473|101|P|   Though it is unlikely, this medication may temporarily slow||
0473|102|P|down a child's growth if used for a long time. See the doctor||
0473|103|P|regularly so your child's height can be checked.||
0473|104|P|   During pregnancy, this medication should be used only when||
0473|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
0473|106|P|   It is unknown if this drug passes into breast milk when||
0473|107|P|applied to the skin. Similar medications pass into breast milk||
0473|108|P|when taken by mouth. Consult your doctor before breastfeeding.||
0473|109|B|||
0473|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0473|111|I|medications work or increase your risk for serious side effects.||
0473|112|I|This document does not contain all possible drug interactions.||
0473|113|I|Keep a list of all the products you use (including||
0473|114|I|prescription/nonprescription drugs and herbal products) and share||
0473|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
0473|116|I|the dosage of any medicines without your doctor's approval.||
0473|117|B|||
0473|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0473|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0473|120|O|poison control center right away. US residents can call||
0473|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0473|122|O|medication may be harmful if swallowed.||
0473|123|B|||
0473|124|N|NOTES:  Do not share this medication with others. This medication||
0473|125|N|has been prescribed for your current condition only. Do not use||
0473|126|N|it later for other skin problems unless told to do so by your||
0473|127|N|doctor. A different medication may be necessary in those cases.||
0473|128|N|   Lab and/or medical tests (such as adrenal gland function) may||
0473|129|N|be done while you are using this medication, especially if you||
0473|130|N|use this drug for an extended period of time or apply it over||
0473|131|N|large areas of the body. Keep all medical and lab appointments.||
0473|132|N|Consult your doctor for more details.||
0473|133|B|||
0473|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0473|135|D|If it is near the time of the next dose, skip the missed dose.||
0473|136|D|Use your next dose at the regular time. Do not double the dose to||
0473|137|D|catch up.||
0473|138|B|||
0473|139|R|STORAGE:  Different brands of this medication have different||
0473|140|R|storage needs. Check the product package for instructions on how||
0473|141|R|to store your brand, or ask your pharmacist. Keep all medications||
0473|142|R|away from children and pets.||
0473|143|R|   Do not flush medications down the toilet or pour them into a||
0473|144|R|drain unless instructed to do so. Properly discard this product||
0473|145|R|when it is expired or no longer needed. Consult your pharmacist||
0473|146|R|or local waste disposal company.||
0473|147|B|||
0473|148|A|Information last revised October 2024.||
0473|149|A|Copyright(c) 2025 First Databank, Inc.||
0473|150|B|||
0474|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0474|002|Z|does NOT have all possible information about this product. This||
0474|003|Z|information does not assure that this product is safe, effective,||
0474|004|Z|or appropriate for you. This information is not individual||
0474|005|Z|medical advice and does not substitute for the advice of your||
0474|006|Z|health care professional. Always ask your health care||
0474|007|Z|professional for complete information about this product and your||
0474|008|Z|specific health needs.||
0474|009|B|||
0474|010|T|DIFLORASONE - TOPICAL||
0474|011|F|(dye-FLOR-a-sone)||
0474|012|B|||
0474|013|C|COMMON BRAND NAME(S): Florone||
0474|014|B|||
0474|015|U|USES:  Diflorasone is used to treat a variety of skin conditions||
0474|016|U|(such as eczema, dermatitis, allergies, rash). Diflorasone||
0474|017|U|reduces the swelling, itching and redness that can occur in these||
0474|018|U|types of conditions. This medication is a strong (high-potency)||
0474|019|U|corticosteroid.||
0474|020|B|||
0474|021|H|HOW TO USE:  Use this medication only on the skin. However, do||
0474|022|H|not use it on the face, groin or underarms unless directed to do||
0474|023|H|so by your doctor.||
0474|024|H|   Wash and dry your hands before applying. Clean and dry the||
0474|025|H|affected area. Apply a thin film of the medication to the||
0474|026|H|affected area and gently rub in as directed by your doctor,||
0474|027|H|usually 1 to 3 times daily. Do not bandage, wrap or cover the||
0474|028|H|area unless directed to do so by your doctor.||
0474|029|H|   After applying the medication, wash your hands, unless you are||
0474|030|H|using this medication to treat the hands. When applying this||
0474|031|H|medication near the eyes, avoid getting it in the eyes because||
0474|032|H|this may worsen or cause glaucoma. Also, avoid getting the||
0474|033|H|medication in your nose or mouth. If you get the medication in||
0474|034|H|your eyes, nose, or mouth, rinse with plenty of water.||
0474|035|H|   Use this medication only for the condition prescribed. Tell||
0474|036|H|your doctor if your condition lasts or gets worse.||
0474|037|B|||
0474|038|S|SIDE EFFECTS:  Burning, stinging, itching, irritation, dryness,||
0474|039|S|or redness may occur when this medication is first applied to the||
0474|040|S|skin. This should disappear in a few days as your body adjusts to||
0474|041|S|the medication. If any of these effects last or get worse, notify||
0474|042|S|your doctor or pharmacist promptly.||
0474|043|S|   Remember that this medication has been prescribed because your||
0474|044|S|doctor has judged that the benefit to you is greater than the||
0474|045|S|risk of side effects. Many people using this medication do not||
0474|046|S|have serious side effects.||
0474|047|S|   Tell your doctor right away if you have any serious side||
0474|048|S|effects, including: stretch marks (striae), skin||
0474|049|S|thinning/discoloration, excessive hair growth, acne, small red||
0474|050|S|bumps on the skin (folliculitis).||
0474|051|S|   Skin infections can become worse when using this medication.||
0474|052|S|Notify your doctor if redness, swelling or irritation does not||
0474|053|S|improve.||
0474|054|S|   Rarely, it is possible this medication will be absorbed from||
0474|055|S|the skin into the bloodstream. This can lead to side effects of||
0474|056|S|too much corticosteroid. These side effects are more likely in||
0474|057|S|children, and in people who use this medication for a long time||
0474|058|S|or over large areas of the skin. Tell your doctor right away if||
0474|059|S|any of the following side effects occur: unusual/extreme||
0474|060|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0474|061|S|thirst/urination, vision problems.||
0474|062|S|   A very serious allergic reaction to this drug is rare.||
0474|063|S|However, get medical help right away if you notice any symptoms||
0474|064|S|of a serious allergic reaction, including: rash, itching/swelling||
0474|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0474|066|S|breathing.||
0474|067|S|   This is not a complete list of possible side effects. If you||
0474|068|S|notice other effects not listed above, contact your doctor or||
0474|069|S|pharmacist.||
0474|070|S|   In the US -||
0474|071|S|   Call your doctor for medical advice about side effects. You||
0474|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0474|073|S|www.fda.gov/medwatch.||
0474|074|S|   In Canada - Call your doctor for medical advice about side||
0474|075|S|effects. You may report side effects to Health Canada at||
0474|076|S|1-866-234-2345.||
0474|077|B|||
0474|078|P|PRECAUTIONS:  Before using diflorasone, tell your doctor or||
0474|079|P|pharmacist if you are allergic to it; or to any other steroids||
0474|080|P|(such as hydrocortisone, dexamethasone); or if you have any other||
0474|081|P|allergies. This product may contain inactive ingredients, which||
0474|082|P|can cause allergic reactions or other problems. Talk to your||
0474|083|P|pharmacist for more details.||
0474|084|P|   Before using this medication, tell your doctor or pharmacist||
0474|085|P|your medical history, especially of: poor blood circulation,||
0474|086|P|diabetes, other skin conditions (such as rosacea, perioral||
0474|087|P|dermatitis), immune system problems.||
0474|088|P|   Do not use if there is an infection or sore in the area to be||
0474|089|P|treated.||
0474|090|P|   Rarely, using corticosteroid medications for a long time or||
0474|091|P|over large areas of skin can make it more difficult for your body||
0474|092|P|to respond to physical stress. Before having surgery or emergency||
0474|093|P|treatment, or if you get a serious illness/injury, tell your||
0474|094|P|doctor or dentist that you are using this medication or have used||
0474|095|P|this medication within the past few months.||
0474|096|P|   Though it is unlikely, this medication may temporarily slow||
0474|097|P|down a child's growth if used for a long time. See the doctor||
0474|098|P|regularly so your child's height can be checked.||
0474|099|P|   During pregnancy, this medication should be used only when||
0474|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0474|101|P|   It is unknown if this drug passes into breast milk when||
0474|102|P|applied to the skin. Similar medications pass into breast milk||
0474|103|P|when taken by mouth. Consult your doctor before breastfeeding.||
0474|104|B|||
0474|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0474|106|I|medications work or increase your risk for serious side effects.||
0474|107|I|This document does not contain all possible drug interactions.||
0474|108|I|Keep a list of all the products you use (including||
0474|109|I|prescription/nonprescription drugs and herbal products) and share||
0474|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0474|111|I|the dosage of any medicines without your doctor's approval.||
0474|112|B|||
0474|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0474|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0474|115|O|poison control center right away. US residents can call||
0474|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0474|117|O|medication can be harmful if swallowed.||
0474|118|B|||
0474|119|N|NOTES:  Do not share this medication with others. This medication||
0474|120|N|has been prescribed for your current condition only. Do not use||
0474|121|N|it later for other skin problems unless told to do so by your||
0474|122|N|doctor. A different medication may be necessary in those cases.||
0474|123|N|   Lab and/or medical tests (such as adrenal gland function) may||
0474|124|N|be done while you are using this medication, especially if you||
0474|125|N|use this drug for an extended period of time or apply it over||
0474|126|N|large areas of the body. Keep all medical and lab appointments.||
0474|127|N|Consult your doctor for more details.||
0474|128|B|||
0474|129|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0474|130|D|If it is near the time of the next dose, skip the missed dose.||
0474|131|D|Use your next dose at the regular time. Do not double the dose to||
0474|132|D|catch up.||
0474|133|B|||
0474|134|R|STORAGE:  Store at room temperature. Keep all medications away||
0474|135|R|from children and pets.||
0474|136|R|   Do not flush medications down the toilet or pour them into a||
0474|137|R|drain unless instructed to do so. Properly discard this product||
0474|138|R|when it is expired or no longer needed. Consult your pharmacist||
0474|139|R|or local waste disposal company.||
0474|140|B|||
0474|141|A|Information last revised October 2024.||
0474|142|A|Copyright(c) 2025 First Databank, Inc.||
0474|143|B|||
0476|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0476|002|Z|does NOT have all possible information about this product. This||
0476|003|Z|information does not assure that this product is safe, effective,||
0476|004|Z|or appropriate for you. This information is not individual||
0476|005|Z|medical advice and does not substitute for the advice of your||
0476|006|Z|health care professional. Always ask your health care||
0476|007|Z|professional for complete information about this product and your||
0476|008|Z|specific health needs.||
0476|009|B|||
0476|010|T|PINDOLOL - ORAL||
0476|011|F|(PIN-doe-lol)||
0476|012|B|||
0476|013|C|COMMON BRAND NAME(S): Visken||
0476|014|B|||
0476|015|W|WARNING:  Do not stop taking this medication without consulting||
0476|016|W|your doctor. Some conditions may become worse when you suddenly||
0476|017|W|stop this drug. Some people who have suddenly stopped taking||
0476|018|W|similar drugs have had chest pain, heart attack, and irregular||
0476|019|W|heartbeat. If your doctor decides you should no longer use this||
0476|020|W|drug, your doctor may direct you to gradually decrease your dose||
0476|021|W|over 1 to 2 weeks.||
0476|022|W|   When gradually stopping this medication, it is recommended||
0476|023|W|that you temporarily limit physical activity to decrease strain||
0476|024|W|on the heart. Get medical help right away if you develop chest||
0476|025|W|pain/tightness/pressure, chest pain spreading to the||
0476|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
0476|027|W|fast/irregular heartbeat.||
0476|028|B|||
0476|029|U|USES:  This medication is used alone or with other medications to||
0476|030|U|treat high blood pressure. Lowering high blood pressure helps||
0476|031|U|prevent strokes, heart attacks and kidney problems. Pindolol||
0476|032|U|belongs to a class of medications called beta-blockers. It works||
0476|033|U|by blocking the effects of certain natural substances (such as||
0476|034|U|epinephrine) on the heart and blood vessels. This results in a||
0476|035|U|lowering of the heart rate, blood pressure, and strain on the||
0476|036|U|heart.||
0476|037|B|||
0476|038|V|OTHER USES:  This section contains uses of this drug that are not||
0476|039|V|listed in the approved professional labeling for the drug but||
0476|040|V|that may be prescribed by your health care professional. Use this||
0476|041|V|drug for a condition that is listed in this section only if it||
0476|042|V|has been so prescribed by your health care professional.||
0476|043|V|   This drug may also be used for a certain type of chest pain||
0476|044|V|(angina). It may reduce how often chest pain happens and improve||
0476|045|V|your ability to exercise.||
0476|046|B|||
0476|047|H|HOW TO USE:  See also Warning section.||
0476|048|H|   Take this medication by mouth with or without food as directed||
0476|049|H|by your doctor, usually twice daily.||
0476|050|H|   The dosage is based on your medical condition and response to||
0476|051|H|treatment. It may take 1-2 weeks before the full benefit of this||
0476|052|H|drug takes effect. Keep taking this medication even if you feel||
0476|053|H|well. Most people with high blood pressure do not feel sick.||
0476|054|H|   Use this medication regularly in order to get the most benefit||
0476|055|H|from it. To help you remember, use it at the same times each day.||
0476|056|H|   Tell your doctor if your condition does not get better or if||
0476|057|H|it gets worse (your blood pressure readings remain high or||
0476|058|H|increase).||
0476|059|B|||
0476|060|S|SIDE EFFECTS:  Dizziness, weakness, and nausea may occur as your||
0476|061|S|body adjusts to the medication. If any of these effects last or||
0476|062|S|get worse, tell your doctor or pharmacist promptly.||
0476|063|S|   This drug may reduce blood flow to your hands and feet,||
0476|064|S|causing them to feel cold. Smoking may worsen this effect. Avoid||
0476|065|S|tobacco use and dress warmly.||
0476|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
0476|067|S|slowly when rising from a sitting or lying position.||
0476|068|S|   Remember that this medication has been prescribed because your||
0476|069|S|doctor has judged that the benefit to you is greater than the||
0476|070|S|risk of side effects. Many people using this medication do not||
0476|071|S|have serious side effects.||
0476|072|S|   Tell your doctor right away if you have any serious side||
0476|073|S|effects, including: new or worsening symptoms of heart failure||
0476|074|S|(such as shortness of breath, swelling ankles/feet, unusual||
0476|075|S|tiredness, unusual/sudden weight gain), bluish color of the||
0476|076|S|fingers/toes/nails, hair loss (reversible), mental/mood changes||
0476|077|S|(such as confusion, depression, memory problems), pain/cramps in||
0476|078|S|the muscles/joints, numbness/tingling, decreased sexual ability,||
0476|079|S|vision changes, slow/irregular/fast heartbeat, fainting.||
0476|080|S|   A very serious allergic reaction to this drug is rare.||
0476|081|S|However, get medical help right away if you notice any symptoms||
0476|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0476|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0476|084|S|breathing.||
0476|085|S|   This is not a complete list of possible side effects. If you||
0476|086|S|notice other effects not listed above, contact your doctor or||
0476|087|S|pharmacist.||
0476|088|S|   In the US -||
0476|089|S|   Call your doctor for medical advice about side effects. You||
0476|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0476|091|S|www.fda.gov/medwatch.||
0476|092|S|   In Canada - Call your doctor for medical advice about side||
0476|093|S|effects. You may report side effects to Health Canada at||
0476|094|S|1-866-234-2345.||
0476|095|B|||
0476|096|P|PRECAUTIONS:  Before taking pindolol, tell your doctor or||
0476|097|P|pharmacist if you are allergic to it; or to other beta-blockers||
0476|098|P|(such as acebutolol); or if you have any other allergies. This||
0476|099|P|product may contain inactive ingredients, which can cause||
0476|100|P|allergic reactions or other problems. Talk to your pharmacist for||
0476|101|P|more details.||
0476|102|P|   Before using this medication, tell your doctor or pharmacist||
0476|103|P|your medical history, especially of: severe allergic reactions||
0476|104|P|(such as anaphylaxis), breathing problems (such as asthma,||
0476|105|P|chronic obstructive lung disease-COPD, emphysema, chronic||
0476|106|P|bronchitis), blood circulation problems (such as Raynaud's||
0476|107|P|disease, peripheral vascular disease), low blood flow to the||
0476|108|P|heart/brain (such as due to coronary artery disease, stroke,||
0476|109|P|transient ischemic attack), diabetes, heart problems (such as||
0476|110|P|heart failure, heart attack, slow heartbeat), kidney disease,||
0476|111|P|liver disease, mental/mood disorders (such as depression), a||
0476|112|P|certain muscle problem (myasthenia gravis), overactive thyroid||
0476|113|P|(hyperthyroidism), a certain adrenal gland tumor||
0476|114|P|(pheochromocytoma).||
0476|115|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0476|116|P|can make you more dizzy. Do not drive, use machinery, or do||
0476|117|P|anything that needs alertness until you can do it safely. Limit||
0476|118|P|alcoholic beverages. Talk to your doctor if you are using||
0476|119|P|marijuana (cannabis).||
0476|120|P|   Before having surgery, tell your doctor or dentist about all||
0476|121|P|the products you use (including prescription drugs,||
0476|122|P|nonprescription drugs, and herbal products).||
0476|123|P|   This drug may rarely make your blood sugar level rise, causing||
0476|124|P|or worsening diabetes. Tell your doctor right away if you develop||
0476|125|P|symptoms of high blood sugar such as increased thirst or frequent||
0476|126|P|urination.||
0476|127|P|   This product may prevent the fast/pounding heartbeat you would||
0476|128|P|usually feel when your blood sugar level falls too low||
0476|129|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0476|130|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0476|131|P|blood sugar level, such as dizziness and sweating, are not||
0476|132|P|affected by this drug.||
0476|133|P|   If you have diabetes, this product may make it harder to||
0476|134|P|control your blood sugar levels. Check your blood sugar levels||
0476|135|P|regularly as directed by your doctor. Tell your doctor right away||
0476|136|P|if you have symptoms of high blood sugar such as increased||
0476|137|P|thirst/urination. Your doctor may need to adjust your diabetes||
0476|138|P|medication, exercise program, or diet.||
0476|139|P|   Older adults may be at greater risk for side effects (such as||
0476|140|P|dizziness) while using this drug.||
0476|141|P|   During pregnancy, this medication should be used only when||
0476|142|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0476|143|P|benefits with your doctor.||
0476|144|P|   This drug passes into breast milk and may have undesirable||
0476|145|P|effects on a nursing infant. Consult your doctor before||
0476|146|P|breastfeeding.||
0476|147|B|||
0476|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0476|149|I|medications work or increase your risk for serious side effects.||
0476|150|I|This document does not contain all possible drug interactions.||
0476|151|I|Keep a list of all the products you use (including||
0476|152|I|prescription/nonprescription drugs and herbal products) and share||
0476|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
0476|154|I|the dosage of any medicines without your doctor's approval.||
0476|155|I|   Some products that may interact with this drug include:||
0476|156|I|epinephrine, fingolimod, thioridazine.||
0476|157|I|   Some products have ingredients that could raise your heart||
0476|158|I|rate or blood pressure. Tell your pharmacist what products you||
0476|159|I|are using, and ask how to use them safely (especially||
0476|160|I|cough-and-cold products, diet aids, or NSAIDs such as||
0476|161|I|ibuprofen/naproxen).||
0476|162|B|||
0476|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0476|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0476|165|O|poison control center right away. US residents can call||
0476|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0476|167|O|Symptoms of overdose may include: very slow heartbeat, severe||
0476|168|O|dizziness/fainting, slow/shallow breathing.||
0476|169|B|||
0476|170|N|NOTES:  Do not share this medication with others. Lifestyle||
0476|171|N|changes such as stress reduction programs, exercise, and dietary||
0476|172|N|changes may increase the effectiveness of this medicine. Talk to||
0476|173|N|your doctor or pharmacist about lifestyle changes that might||
0476|174|N|benefit you.||
0476|175|N|   Have your blood pressure checked regularly while taking this||
0476|176|N|medication. Discuss with your doctor how to monitor your own||
0476|177|N|blood pressure and pulse.||
0476|178|N|   Lab and/or medical tests (such as blood pressure, liver||
0476|179|N|function) should be done while you are taking this medication.||
0476|180|N|Keep all medical and lab appointments. Consult your doctor for||
0476|181|N|more details.||
0476|182|B|||
0476|183|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0476|184|D|remember. If it is near the time of the next dose, skip the||
0476|185|D|missed dose. Take your next dose at the regular time. Do not||
0476|186|D|double the dose to catch up.||
0476|187|B|||
0476|188|R|STORAGE:  Store at room temperature away from light and moisture.||
0476|189|R|Do not store in the bathroom. Keep all medications away from||
0476|190|R|children and pets.||
0476|191|R|   Do not flush medications down the toilet or pour them into a||
0476|192|R|drain unless instructed to do so. Properly discard this product||
0476|193|R|when it is expired or no longer needed. Consult your pharmacist||
0476|194|R|or local waste disposal company.||
0476|195|B|||
0476|196|M|MEDICAL ALERT:  Your condition can cause complications in a||
0476|197|M|medical emergency. For information about enrolling in MedicAlert,||
0476|198|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0476|199|B|||
0476|200|A|Information last revised August 2024.||
0476|201|A|Copyright(c) 2025 First Databank, Inc.||
0476|202|B|||
0477|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0477|002|Z|does NOT have all possible information about this product. This||
0477|003|Z|information does not assure that this product is safe, effective,||
0477|004|Z|or appropriate for you. This information is not individual||
0477|005|Z|medical advice and does not substitute for the advice of your||
0477|006|Z|health care professional. Always ask your health care||
0477|007|Z|professional for complete information about this product and your||
0477|008|Z|specific health needs.||
0477|009|B|||
0477|010|T|HAEMOPHILUS INFLUENZAE B VACCINE - INJECTION||
0477|011|F|(HEE-moe-FIL-us IN-floo-EN-za vak-SEEN)||
0477|012|B|||
0477|013|C|COMMON BRAND NAME(S): Acthib, Hibtiter||
0477|014|B|||
0477|015|U|USES:  This vaccine is used to help prevent Haemophilus||
0477|016|U|influenzae type b (Hib) infection. Hib is a bacterial infection||
0477|017|U|that can cause serious illness, including brain infection||
0477|018|U|(meningitis). Vaccination is the best way to protect against this||
0477|019|U|life-threatening infection. This vaccine works by increasing the||
0477|020|U|body's natural defense (immunity) against the bacteria.||
0477|021|U|   This vaccine is usually given to children between 2 months and||
0477|022|U|5 years old.||
0477|023|U|   Vaccines may not fully protect everyone who receives them.||
0477|024|B|||
0477|025|H|HOW TO USE:  Read all vaccine information available from your||
0477|026|H|health care professional before receiving the vaccine. If you||
0477|027|H|have any questions, ask your health care professional.||
0477|028|H|   This vaccine is given by injection into a muscle by a health||
0477|029|H|care professional. It is given in the upper arm for children and||
0477|030|H|in the thigh for infants.||
0477|031|H|   Vaccines are usually given in a series of doses to provide the||
0477|032|H|best protection. Closely follow the vaccination schedule provided||
0477|033|H|by your health care professional. To help you remember, mark your||
0477|034|H|calendar with a reminder.||
0477|035|H|   This vaccine may be given at the same time as other vaccines.||
0477|036|B|||
0477|037|S|SIDE EFFECTS:  Pain/swelling/redness at the injection site,||
0477|038|S|drowsiness, irritability/crying, loss of appetite, diarrhea,||
0477|039|S|fever, or vomiting may also occur. If any of these effects last||
0477|040|S|or get worse, tell the health care professional promptly.||
0477|041|S|   Rarely, some people have symptoms such as fainting, dizziness,||
0477|042|S|vision changes, or ringing in the ears just after getting a||
0477|043|S|vaccine injection. Tell the health care professional right away||
0477|044|S|if your child has any of these symptoms. Sitting or lying down||
0477|045|S|may help, since these symptoms usually don't last long.||
0477|046|S|   Remember that this vaccine has been prescribed because the||
0477|047|S|health care professional has judged that the benefit to your||
0477|048|S|child is greater than the risk of side effects. Many people using||
0477|049|S|this vaccine do not have serious side effects.||
0477|050|S|   Tell your health care professional right away if your child||
0477|051|S|has any serious side effects, including: little or no response to||
0477|052|S|sound/touch, weak/floppy muscles.||
0477|053|S|   A very serious allergic reaction to this vaccine is rare.||
0477|054|S|However, get medical help right away if you notice any symptoms||
0477|055|S|of a serious allergic reaction, including: rash, itching/swelling||
0477|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0477|057|S|breathing.||
0477|058|S|   This is not a complete list of possible side effects. If you||
0477|059|S|notice other effects not listed above, contact your health care||
0477|060|S|professional.||
0477|061|S|   Contact the health care professional for medical advice about||
0477|062|S|side effects. The following numbers do not provide medical||
0477|063|S|advice, but in the US you may report side effects to the Vaccine||
0477|064|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
0477|065|S|Canada, you may call the Vaccine Safety Section at Public Health||
0477|066|S|Agency of Canada at 1-866-844-0018.||
0477|067|B|||
0477|068|P|PRECAUTIONS:  Before your child receives this vaccine, tell the||
0477|069|P|health care professional if your child is allergic to it; or if||
0477|070|P|your child has any other allergies. This product may contain||
0477|071|P|inactive ingredients (such as latex found in some brands), which||
0477|072|P|can cause allergic reactions or other problems. Talk to your||
0477|073|P|health care professional for more details.||
0477|074|P|   Before receiving this vaccine, tell the health care||
0477|075|P|professional your child's medical history, especially of: current||
0477|076|P|fever/illness, a certain nerve disorder (Guillain-Barre||
0477|077|P|syndrome), immune system disorders (such as due to HIV infection,||
0477|078|P|certain cancers such as leukemia/lymphoma, cancer or radiation||
0477|079|P|treatment), vaccination history (including previous reactions to||
0477|080|P|any vaccines).||
0477|081|P|   This vaccine is not usually used by adults. It is unlikely to||
0477|082|P|be used during pregnancy or breastfeeding. Consult the health||
0477|083|P|care professional if you have any questions about using this||
0477|084|P|vaccine.||
0477|085|B|||
0477|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0477|087|I|medications work or increase your risk for serious side effects.||
0477|088|I|This document does not contain all possible drug interactions.||
0477|089|I|Keep a list of all the products you use (including||
0477|090|I|prescription/nonprescription drugs and herbal products) and share||
0477|091|I|it with your health care professional. Do not start, stop, or||
0477|092|I|change the dosage of any medicines without your doctor's||
0477|093|I|approval.||
0477|094|I|   Some products that may interact with this vaccine are: drugs||
0477|095|I|that weaken the immune system (including cyclosporine,||
0477|096|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
0477|097|I|prednisone).||
0477|098|I|   This vaccine may interfere with certain lab tests, possibly||
0477|099|I|causing false test results. Make sure lab personnel and all the||
0477|100|I|doctors know your child recently received this vaccine.||
0477|101|B|||
0477|102|O|OVERDOSE:  Not applicable.||
0477|103|B|||
0477|104|N|NOTES:  Keep all medical and lab appointments.||
0477|105|N|   Keep vaccine records for yourself and your children and||
0477|106|N|provide them to the health care professionals to prevent||
0477|107|N|unnecessary re-vaccinations.||
0477|108|B|||
0477|109|D|MISSED DOSE:  It is important that your child gets each||
0477|110|D|vaccination as scheduled. Ask when your child should get each||
0477|111|D|dose and mark your calendar with a reminder. If your child misses||
0477|112|D|a dose, call the health care professional to reschedule.||
0477|113|B|||
0477|114|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
0477|115|R|light. Keep all medications away from children and pets.||
0477|116|R|   Do not flush medications down the toilet or pour them into a||
0477|117|R|drain unless instructed to do so. Properly discard this product||
0477|118|R|when it is expired or no longer needed. Consult your pharmacist||
0477|119|R|or local waste disposal company.||
0477|120|B|||
0477|121|A|Information last revised February 2025.||
0477|122|A|Copyright(c) 2025 First Databank, Inc.||
0477|123|B|||
0478|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0478|002|Z|does NOT have all possible information about this product. This||
0478|003|Z|information does not assure that this product is safe, effective,||
0478|004|Z|or appropriate for you. This information is not individual||
0478|005|Z|medical advice and does not substitute for the advice of your||
0478|006|Z|health care professional. Always ask your health care||
0478|007|Z|professional for complete information about this product and your||
0478|008|Z|specific health needs.||
0478|009|B|||
0478|010|T|FOLLITROPIN BETA CARTRIDGE - INJECTION||
0478|011|F|(FOL-i-TROE-pin Bay-ta)||
0478|012|B|||
0478|013|C|COMMON BRAND NAME(S): Follistim AQ||
0478|014|B|||
0478|015|U|USES:  This medication contains follicle-stimulating hormone||
0478|016|U|(FSH) and is used to treat certain fertility problems in women||
0478|017|U|and men. In women, it helps stimulate healthy ovaries to produce||
0478|018|U|eggs. This medication is usually used in combination with another||
0478|019|U|hormone (hCG) to bring about the growth and release of a mature||
0478|020|U|egg (ovulation). In men, it helps stimulate healthy testes to||
0478|021|U|produce sperm. It is also used in combination with hCG.||
0478|022|U|   This medication is not recommended for women whose ovaries no||
0478|023|U|longer make eggs properly (primary ovarian failure) or for men||
0478|024|U|whose testes no longer make sperm properly (primary testicular||
0478|025|U|failure).||
0478|026|B|||
0478|027|H|HOW TO USE:  Read the Patient Information Leaflet and||
0478|028|H|Instructions for Use if available from your pharmacist before you||
0478|029|H|start using follitropin beta and each time you get a refill. Ask||
0478|030|H|your health care professional how to prepare and use this||
0478|031|H|medication. If you have any questions, ask your doctor or||
0478|032|H|pharmacist.||
0478|033|H|   Inject this medication under the skin as directed by your||
0478|034|H|doctor. The injection is given in the thighs or abdomen. The||
0478|035|H|dosage is based on your medical condition, response to treatment,||
0478|036|H|and labs.||
0478|037|H|   If the medication is stored in the refrigerator, allow the||
0478|038|H|medication to reach room temperature before use. Before using,||
0478|039|H|check this product for particles or discoloration. If either is||
0478|040|H|present, do not use the liquid. Before injecting each dose, clean||
0478|041|H|the skin you are going to inject into (the injection site) with||
0478|042|H|rubbing alcohol. Change the injection site each time to lessen||
0478|043|H|injury under the skin. To lessen bruising, do not rub the||
0478|044|H|injection site after a shot. Learn how to store and discard||
0478|045|H|medical supplies safely.||
0478|046|H|   The different follitropin products are not interchangeable and||
0478|047|H|the doses may be different. Do not switch to a different brand or||
0478|048|H|type without your doctor's approval.||
0478|049|H|   Use this medication exactly as directed by your doctor to get||
0478|050|H|the most benefit from it. Do not increase your dose or use this||
0478|051|H|drug more often or for longer than prescribed.||
0478|052|B|||
0478|053|S|SIDE EFFECTS:  Headache, stomach pain, bloating, redness/pain at||
0478|054|S|the injection site, or breast tenderness/pain may occur. If any||
0478|055|S|of these effects last or get worse, tell your doctor or||
0478|056|S|pharmacist promptly.||
0478|057|S|   Remember that this medication has been prescribed because your||
0478|058|S|doctor has judged that the benefit to you is greater than the||
0478|059|S|risk of side effects. Many people using this medication do not||
0478|060|S|have serious side effects.||
0478|061|S|   Tell your doctor right away if you have any serious side||
0478|062|S|effects, including: flu-like symptoms (such as fever, chills,||
0478|063|S|muscle ache, tiredness), bleeding from the vagina, swelling of||
0478|064|S|ankles/hands/feet.||
0478|065|S|   Get medical help right away if you have any very serious side||
0478|066|S|effects, including: shortness of breath/rapid breathing,||
0478|067|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
0478|068|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0478|069|S|sudden severe headache, trouble speaking, weakness on one side of||
0478|070|S|the body, sudden vision changes.||
0478|071|S|   This medication may cause a condition known as ovarian||
0478|072|S|hyperstimulation syndrome (OHSS). This condition may occur during||
0478|073|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
0478|074|S|build up in the stomach, chest, and heart area. Get medical help||
0478|075|S|right away if you develop the following side effects: severe pain||
0478|076|S|or swelling in the lower abdominal (pelvic) area, severe||
0478|077|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
0478|078|S|urination.||
0478|079|S|   A very serious allergic reaction to this drug is rare.||
0478|080|S|However, get medical help right away if you notice any symptoms||
0478|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0478|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0478|083|S|breathing.||
0478|084|S|   This is not a complete list of possible side effects. If you||
0478|085|S|notice other effects not listed above, contact your doctor or||
0478|086|S|pharmacist.||
0478|087|S|   In the US -||
0478|088|S|   Call your doctor for medical advice about side effects. You||
0478|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0478|090|S|www.fda.gov/medwatch.||
0478|091|S|   In Canada - Call your doctor for medical advice about side||
0478|092|S|effects. You may report side effects to Health Canada at||
0478|093|S|1-866-234-2345.||
0478|094|B|||
0478|095|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0478|096|P|pharmacist if you are allergic to it; or to other products||
0478|097|P|containing follicle-stimulating hormone (FSH); or to||
0478|098|P|streptomycin; or to neomycin; or if you have any other allergies.||
0478|099|P|This product may contain inactive ingredients, which can cause||
0478|100|P|allergic reactions or other problems. Talk to your pharmacist for||
0478|101|P|more details.||
0478|102|P|   Before using this medication, tell your doctor or pharmacist||
0478|103|P|your medical history, especially of: abnormal bleeding from the||
0478|104|P|vagina or uterus, thyroid problems, adrenal gland problems,||
0478|105|P|cancer of the reproductive organs (breast, uterus, ovary,||
0478|106|P|testis), tumor in the brain (such as pituitary tumor), ovarian||
0478|107|P|cysts or enlargement, other fertility problems (such as primary||
0478|108|P|ovarian failure or testicular failure), blood clots, stroke,||
0478|109|P|certain heart diseases (such as angina, heart attack), lung||
0478|110|P|problems (such as asthma).||
0478|111|P|   Before having surgery, tell your doctor or dentist about all||
0478|112|P|the products you use (including prescription drugs,||
0478|113|P|nonprescription drugs, and herbal products).||
0478|114|P|   Multiple births may occur because of this treatment. Consult||
0478|115|P|your doctor for more details.||
0478|116|P|   Stop using this medication when you become pregnant. This||
0478|117|P|medication must not be used during pregnancy. If you think you||
0478|118|P|may be pregnant, tell your doctor right away.||
0478|119|P|   It is unknown if this drug passes into breast milk. Consult||
0478|120|P|your doctor before breastfeeding.||
0478|121|B|||
0478|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0478|123|I|medications work or increase your risk for serious side effects.||
0478|124|I|This document does not contain all possible drug interactions.||
0478|125|I|Keep a list of all the products you use (including||
0478|126|I|prescription/nonprescription drugs and herbal products) and share||
0478|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
0478|128|I|the dosage of any medicines without your doctor's approval.||
0478|129|I|   A product that may interact with this drug is: gonadorelin.||
0478|130|B|||
0478|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0478|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0478|133|O|poison control center right away. US residents can call||
0478|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0478|135|B|||
0478|136|N|NOTES:  Do not share this medication with others.||
0478|137|N|   Lab and/or medical tests (such as vaginal ultrasound, hormone||
0478|138|N|levels, semen test) may be done while you are using this||
0478|139|N|medication. Keep all medical and lab appointments. Consult your||
0478|140|N|doctor for more details.||
0478|141|B|||
0478|142|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
0478|143|D|right away for a new dosing schedule. Do not double the dose to||
0478|144|D|catch up.||
0478|145|B|||
0478|146|R|STORAGE:  Store the unused cartridge in the refrigerator. The||
0478|147|R|unused cartridge may also be stored at room temperature if||
0478|148|R|needed. If the unused cartridge is stored at room temperature,||
0478|149|R|discard after 3 months. Once used, this product may be stored in||
0478|150|R|the refrigerator or at room temperature. Discard the used||
0478|151|R|cartridge after 28 days. Keep the medication in the original||
0478|152|R|carton to protect from light. Do not freeze. Keep all medications||
0478|153|R|away from children and pets.||
0478|154|R|   Do not flush medications down the toilet or pour them into a||
0478|155|R|drain unless instructed to do so. Properly discard this product||
0478|156|R|when it is expired or no longer needed. Consult your pharmacist||
0478|157|R|or local waste disposal company.||
0478|158|B|||
0478|159|A|Information last revised September 2024.||
0478|160|A|Copyright(c) 2025 First Databank, Inc.||
0478|161|B|||
0479|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0479|002|Z|does NOT have all possible information about this product. This||
0479|003|Z|information does not assure that this product is safe, effective,||
0479|004|Z|or appropriate for you. This information is not individual||
0479|005|Z|medical advice and does not substitute for the advice of your||
0479|006|Z|health care professional. Always ask your health care||
0479|007|Z|professional for complete information about this product and your||
0479|008|Z|specific health needs.||
0479|009|B|||
0479|010|T|FOLLITROPIN ALFA PEN - INJECTION||
0479|011|F|(FOL-i-TROE-pin AL-fa)||
0479|012|B|||
0479|013|C|COMMON BRAND NAME(S): Gonal-F RFF||
0479|014|B|||
0479|015|U|USES:  This medication contains follicle-stimulating hormone||
0479|016|U|(FSH) and is used to treat certain fertility problems in women.||
0479|017|U|Follitropin alfa helps stimulate healthy ovaries to produce eggs.||
0479|018|U|This medication is usually used in combination with another||
0479|019|U|hormone (hCG) to bring about the growth and release of a mature||
0479|020|U|egg (ovulation).||
0479|021|U|   This medication is not recommended for women whose ovaries no||
0479|022|U|longer make eggs properly (primary ovarian failure).||
0479|023|B|||
0479|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
0479|025|H|Instructions for Use if available from your pharmacist before you||
0479|026|H|start using follitropin alfa and each time you get a refill. Ask||
0479|027|H|your health care professional how to prepare and use this||
0479|028|H|medication. If you have any questions, ask your doctor or||
0479|029|H|pharmacist.||
0479|030|H|   Inject this medication under the skin as directed by your||
0479|031|H|doctor, usually once a day. The injection is given in the||
0479|032|H|abdomen. Your doctor may direct you to use this medication in a||
0479|033|H|treatment cycle (for example, only on certain days each month).||
0479|034|H|The dosage is based on your medical condition, response to||
0479|035|H|treatment, and labs.||
0479|036|H|   If the medication is stored in the refrigerator, allow the||
0479|037|H|medication to reach room temperature before use. Before using,||
0479|038|H|check this product for particles or discoloration. If either is||
0479|039|H|present, do not use the liquid. Before injecting each dose, clean||
0479|040|H|the skin you are going to inject into (the injection site) with||
0479|041|H|rubbing alcohol. Change the injection site each time to lessen||
0479|042|H|injury under the skin. To lessen bruising, do not rub the||
0479|043|H|injection site after a shot. Learn how to store and discard||
0479|044|H|medical supplies safely.||
0479|045|H|   Use this medication exactly as directed by your doctor to get||
0479|046|H|the most benefit from it. Do not increase your dose or use this||
0479|047|H|drug more often or for longer than prescribed.||
0479|048|B|||
0479|049|S|SIDE EFFECTS:  Headache, mild stomach/abdominal pain, bloating,||
0479|050|S|redness/pain at the injection site, or breast tenderness/pain may||
0479|051|S|occur. If any of these effects last or get worse, tell your||
0479|052|S|doctor or pharmacist promptly.||
0479|053|S|   Remember that this medication has been prescribed because your||
0479|054|S|doctor has judged that the benefit to you is greater than the||
0479|055|S|risk of side effects. Many people using this medication do not||
0479|056|S|have serious side effects.||
0479|057|S|   Tell your doctor right away if you have any serious side||
0479|058|S|effects, including: bleeding from the vagina/uterus, flu-like||
0479|059|S|symptoms (such as fever, chills, muscle ache, tiredness),||
0479|060|S|swelling of ankles/hands/feet.||
0479|061|S|   Get medical help right away if you have any very serious side||
0479|062|S|effects, including: shortness of breath/rapid breathing,||
0479|063|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
0479|064|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0479|065|S|sudden severe headache, trouble speaking, weakness on one side of||
0479|066|S|the body, sudden vision changes.||
0479|067|S|   This medication may cause a condition known as ovarian||
0479|068|S|hyperstimulation syndrome (OHSS). This condition may occur during||
0479|069|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
0479|070|S|build up in the stomach, chest, and heart area. Get medical help||
0479|071|S|right away if you develop the following side effects: severe pain||
0479|072|S|or swelling in the lower abdominal (pelvic) area, severe||
0479|073|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
0479|074|S|urination.||
0479|075|S|   A very serious allergic reaction to this drug is rare.||
0479|076|S|However, get medical help right away if you notice any symptoms||
0479|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0479|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0479|079|S|breathing.||
0479|080|S|   This is not a complete list of possible side effects. If you||
0479|081|S|notice other effects not listed above, contact your doctor or||
0479|082|S|pharmacist.||
0479|083|S|   In the US -||
0479|084|S|   Call your doctor for medical advice about side effects. You||
0479|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0479|086|S|www.fda.gov/medwatch.||
0479|087|S|   In Canada - Call your doctor for medical advice about side||
0479|088|S|effects. You may report side effects to Health Canada at||
0479|089|S|1-866-234-2345.||
0479|090|B|||
0479|091|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0479|092|P|pharmacist if you are allergic to it; or to other products||
0479|093|P|containing follicle-stimulating hormone (FSH); or if you have any||
0479|094|P|other allergies. This product may contain inactive ingredients,||
0479|095|P|which can cause allergic reactions or other problems. Talk to||
0479|096|P|your pharmacist for more details.||
0479|097|P|   Before using this medication, tell your doctor or pharmacist||
0479|098|P|your medical history, especially of: other fertility problems||
0479|099|P|(such as primary ovarian failure), abnormal bleeding from the||
0479|100|P|vagina/uterus, thyroid problems, adrenal gland problems, cancer||
0479|101|P|of the reproductive organs (such as breast, uterus, ovary), tumor||
0479|102|P|in the brain (such as pituitary tumor), ovarian cysts or enlarged||
0479|103|P|ovaries, blood clots, stroke, certain heart diseases (such as||
0479|104|P|angina, heart attack), lung problems (such as asthma).||
0479|105|P|   Before having surgery, tell your doctor or dentist about all||
0479|106|P|the products you use (including prescription drugs,||
0479|107|P|nonprescription drugs, and herbal products).||
0479|108|P|   Multiple births may occur as a result of this treatment.||
0479|109|P|Consult your doctor for more details.||
0479|110|P|   Stop using this medication when you become pregnant. This||
0479|111|P|medication must not be used during pregnancy. If you think you||
0479|112|P|may be pregnant, tell your doctor right away.||
0479|113|P|   It is unknown if this drug passes into breast milk. Consult||
0479|114|P|your doctor before breastfeeding.||
0479|115|B|||
0479|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0479|117|I|medications work or increase your risk for serious side effects.||
0479|118|I|This document does not contain all possible drug interactions.||
0479|119|I|Keep a list of all the products you use (including||
0479|120|I|prescription/nonprescription drugs and herbal products) and share||
0479|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
0479|122|I|the dosage of any medicines without your doctor's approval.||
0479|123|I|   A product that may interact with this drug is: gonadorelin.||
0479|124|B|||
0479|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0479|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0479|127|O|poison control center right away. US residents can call||
0479|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0479|129|B|||
0479|130|N|NOTES:  Do not share this medication with others.||
0479|131|N|   Lab and/or medical tests (such as vaginal ultrasound, hormone||
0479|132|N|levels, liver tests) may be done while you are using this||
0479|133|N|medication. Keep all medical and lab appointments. Consult your||
0479|134|N|doctor for more details.||
0479|135|B|||
0479|136|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
0479|137|D|right away for a new dosing schedule. Do not double the dose to||
0479|138|D|catch up.||
0479|139|B|||
0479|140|R|STORAGE:  Store the unused pen in the refrigerator. The unused||
0479|141|R|pen may also be stored at room temperature if needed. If the||
0479|142|R|unused pen is stored at room temperature, discard after 3 months.||
0479|143|R|Once used, this product may be stored in the refrigerator or at||
0479|144|R|room temperature. Discard the used pen after 28 days. Keep the||
0479|145|R|medication in the original carton to protect from light. Do not||
0479|146|R|freeze. Keep all medications away from children and pets.||
0479|147|R|   Do not flush medications down the toilet or pour them into a||
0479|148|R|drain unless instructed to do so. Properly discard this product||
0479|149|R|when it is expired or no longer needed. Consult your pharmacist||
0479|150|R|or local waste disposal company.||
0479|151|B|||
0479|152|A|Information last revised September 2024.||
0479|153|A|Copyright(c) 2025 First Databank, Inc.||
0479|154|B|||
0481|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0481|002|Z|does NOT have all possible information about this product. This||
0481|003|Z|information does not assure that this product is safe, effective,||
0481|004|Z|or appropriate for you. This information is not individual||
0481|005|Z|medical advice and does not substitute for the advice of your||
0481|006|Z|health care professional. Always ask your health care||
0481|007|Z|professional for complete information about this product and your||
0481|008|Z|specific health needs.||
0481|009|B|||
0481|010|T|TINIDAZOLE - ORAL||
0481|011|F|(tye-NID-a-zole)||
0481|012|B|||
0481|013|C|COMMON BRAND NAME(S): Tindamax||
0481|014|B|||
0481|015|U|USES:  Tinidazole is an antibiotic that is used to treat certain||
0481|016|U|types of vaginal infections (bacterial vaginosis,||
0481|017|U|trichomoniasis). It is also used to treat certain types of||
0481|018|U|parasite infections (giardiasis, amebiasis). It works by stopping||
0481|019|U|the growth of certain bacteria and parasites.||
0481|020|U|   This antibiotic treats only certain bacterial and parasitic||
0481|021|U|infections. It will not work for viral infections (such as common||
0481|022|U|cold, flu). Using any antibiotic when it is not needed can cause||
0481|023|U|it to not work for future infections.||
0481|024|B|||
0481|025|H|HOW TO USE:  Take this medication by mouth as directed by your||
0481|026|H|doctor, usually once daily. To prevent stomach upset, take this||
0481|027|H|medication with food. The dosage is based on your medical||
0481|028|H|condition and response to treatment. Children's dosage is also||
0481|029|H|based on weight.||
0481|030|H|   For the best effect, take this antibiotic at evenly spaced||
0481|031|H|times. To help you remember, take this medication at the same||
0481|032|H|time(s) every day.||
0481|033|H|   Continue to take this medication until the full prescribed||
0481|034|H|amount is finished, even if symptoms disappear after a short||
0481|035|H|time. Stopping the medication too early may result in a return of||
0481|036|H|the infection.||
0481|037|H|   Tell your doctor if your condition lasts or gets worse.||
0481|038|B|||
0481|039|S|SIDE EFFECTS:  Bitter/metallic taste in your mouth, nausea,||
0481|040|S|stomach upset, diarrhea, or dizziness may occur. If any of these||
0481|041|S|effects last or get worse, tell your doctor or pharmacist||
0481|042|S|promptly.||
0481|043|S|   This medication may cause your urine to turn darker in color.||
0481|044|S|This effect is harmless and will disappear when the medication is||
0481|045|S|stopped.||
0481|046|S|   Remember that this medication has been prescribed because your||
0481|047|S|doctor has judged that the benefit to you is greater than the||
0481|048|S|risk of side effects. Many people using this medication do not||
0481|049|S|have serious side effects.||
0481|050|S|   Tell your doctor right away if you have any serious side||
0481|051|S|effects, including: signs of a new infection (such as sore throat||
0481|052|S|that doesn't go away, fever), easy bruising/bleeding.||
0481|053|S|   Get medical help right away if you have any very serious side||
0481|054|S|effects, including: unsteadiness, seizures, numbness/tingling of||
0481|055|S|arms/legs.||
0481|056|S|   Use of this medication for prolonged or repeated periods may||
0481|057|S|result in oral thrush or a new yeast infection. Contact your||
0481|058|S|doctor if you notice white patches in your mouth, a change in||
0481|059|S|vaginal discharge, or other new symptoms.||
0481|060|S|   A very serious allergic reaction to this drug is rare.||
0481|061|S|However, get medical help right away if you notice any symptoms||
0481|062|S|of a serious allergic reaction, including: rash, itching/swelling||
0481|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0481|064|S|breathing.||
0481|065|S|   This is not a complete list of possible side effects. If you||
0481|066|S|notice other effects not listed above, contact your doctor or||
0481|067|S|pharmacist.||
0481|068|S|   In the US -||
0481|069|S|   Call your doctor for medical advice about side effects. You||
0481|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0481|071|S|www.fda.gov/medwatch.||
0481|072|S|   In Canada - Call your doctor for medical advice about side||
0481|073|S|effects. You may report side effects to Health Canada at||
0481|074|S|1-866-234-2345.||
0481|075|B|||
0481|076|P|PRECAUTIONS:  Before taking tinidazole, tell your doctor or||
0481|077|P|pharmacist if you are allergic to it; or to other antibiotics||
0481|078|P|(such as metronidazole); or if you have any other allergies. This||
0481|079|P|product may contain inactive ingredients, which can cause||
0481|080|P|allergic reactions or other problems. Talk to your pharmacist for||
0481|081|P|more details.||
0481|082|P|   Before using this medication, tell your doctor or pharmacist||
0481|083|P|your medical history, especially of: liver disease, kidney||
0481|084|P|dialysis, certain blood disorders (low blood cell counts), a||
0481|085|P|certain rare genetic disorder (Cockayne syndrome).||
0481|086|P|   Avoid alcoholic beverages and products containing propylene||
0481|087|P|glycol while taking this medication and for at least 3 days after||
0481|088|P|finishing this medicine because severe stomach upset/cramps,||
0481|089|P|nausea, vomiting, headache, and flushing may occur.||
0481|090|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0481|091|P|can make you more dizzy. Do not drive, use machinery, or do||
0481|092|P|anything that needs alertness until you can do it safely. Talk to||
0481|093|P|your doctor if you are using marijuana (cannabis).||
0481|094|P|   Tinidazole may cause live bacterial vaccines (such as typhoid||
0481|095|P|vaccine) to not work well. Tell your health care professional||
0481|096|P|that you are using tinidazole before having any||
0481|097|P|immunizations/vaccinations.||
0481|098|P|   Before having surgery, tell your doctor or dentist about all||
0481|099|P|the products you use (including prescription drugs,||
0481|100|P|nonprescription drugs, and herbal products).||
0481|101|P|   During pregnancy, this medication should be used only when||
0481|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0481|103|P|   This drug passes into breast milk and could have undesirable||
0481|104|P|effects on a nursing infant. Breastfeeding is not recommended||
0481|105|P|while using this drug and for at least 3 days after the last||
0481|106|P|dose. Consult your doctor before breastfeeding.||
0481|107|B|||
0481|108|I|DRUG INTERACTIONS:  See also Precautions section.||
0481|109|I|   Drug interactions may change how your medications work or||
0481|110|I|increase your risk for serious side effects. This document does||
0481|111|I|not contain all possible drug interactions. Keep a list of all||
0481|112|I|the products you use (including prescription/nonprescription||
0481|113|I|drugs and herbal products) and share it with your doctor and||
0481|114|I|pharmacist. Do not start, stop, or change the dosage of any||
0481|115|I|medicines without your doctor's approval.||
0481|116|I|   Some products that may interact with this drug include:||
0481|117|I|alcohol-containing products (such as cough and cold syrups,||
0481|118|I|aftershave), products containing propylene glycol,||
0481|119|I|lopinavir/ritonavir solution, lithium.||
0481|120|I|   Do not take tinidazole if you are also taking disulfiram or if||
0481|121|I|you have taken disulfiram within the last 2 weeks.||
0481|122|I|   This medication may interfere with certain lab tests, possibly||
0481|123|I|causing false test results. Make sure lab personnel and all your||
0481|124|I|doctors know you use this drug.||
0481|125|B|||
0481|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0481|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0481|128|O|poison control center right away. US residents can call||
0481|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0481|130|B|||
0481|131|N|NOTES:  Do not share this medication with others.||
0481|132|N|   If you are being treated for trichomoniasis, all sexual||
0481|133|N|partners may also need to be treated to avoid re-infection.||
0481|134|N|During treatment, avoid sexual intercourse, or always use a latex||
0481|135|N|or polyurethane condom.||
0481|136|N|   This medication has been prescribed for your current condition||
0481|137|N|only. Do not use it later for another infection unless your||
0481|138|N|doctor tells you to.||
0481|139|N|   If you are taking this medication for a longer time, lab tests||
0481|140|N|(such as blood cell counts) may be done while you are taking this||
0481|141|N|medication. Keep all medical and lab appointments. Consult your||
0481|142|N|doctor for more details.||
0481|143|B|||
0481|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0481|145|D|remember. If it is near the time of the next dose, skip the||
0481|146|D|missed dose. Take your next dose at the regular time. Do not||
0481|147|D|double the dose to catch up.||
0481|148|B|||
0481|149|R|STORAGE:  Store at room temperature away from light and moisture.||
0481|150|R|Do not store in the bathroom. Keep all medications away from||
0481|151|R|children and pets.||
0481|152|R|   Do not flush medications down the toilet or pour them into a||
0481|153|R|drain unless instructed to do so. Properly discard this product||
0481|154|R|when it is expired or no longer needed. Consult your pharmacist||
0481|155|R|or local waste disposal company.||
0481|156|B|||
0481|157|A|Information last revised August 2024.||
0481|158|A|Copyright(c) 2025 First Databank, Inc.||
0481|159|B|||
0483|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0483|002|Z|does NOT have all possible information about this product. This||
0483|003|Z|information does not assure that this product is safe, effective,||
0483|004|Z|or appropriate for you. This information is not individual||
0483|005|Z|medical advice and does not substitute for the advice of your||
0483|006|Z|health care professional. Always ask your health care||
0483|007|Z|professional for complete information about this product and your||
0483|008|Z|specific health needs.||
0483|009|B|||
0483|010|T|PREDNISOLONE - OPHTHALMIC||
0483|011|F|(pred-NIS-oh-loan)||
0483|012|B|||
0483|013|C|COMMON BRAND NAME(S): Pred Forte, Pred Mild||
0483|014|B|||
0483|015|U|USES:  This medication is used to treat certain eye conditions||
0483|016|U|due to inflammation or injury. Prednisolone works by relieving||
0483|017|U|symptoms such as swelling, redness, and itching. It belongs to a||
0483|018|U|class of drugs known as corticosteroids.||
0483|019|B|||
0483|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0483|021|H|directed by your doctor, usually 2 to 4 times a day.||
0483|022|H|   Unless otherwise directed by your doctor, do not wear contact||
0483|023|H|lenses while you are using this medicine. Sterilize contact||
0483|024|H|lenses according to the manufacturer's directions, and check with||
0483|025|H|your doctor before you begin using them again.||
0483|026|H|   If your doctor does approve the wearing of contact lenses||
0483|027|H|during treatment with this medication, remove the lenses before||
0483|028|H|using the eye drops. The preservative in this product may be||
0483|029|H|absorbed by contact lenses. Wait at least 15 minutes after each||
0483|030|H|dose of the eye drop before wearing the lenses again.||
0483|031|H|   To apply eye drops, wash your hands first. If you are using a||
0483|032|H|suspension form of this medication, shake the bottle well before||
0483|033|H|using. To avoid contamination, do not touch the dropper tip or||
0483|034|H|let it touch your eye or any other surface.||
0483|035|H|   Tilt your head back, look upward, and pull down the lower||
0483|036|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0483|037|H|and place 1 drop into the pouch. Look downward and gently close||
0483|038|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0483|039|H|your eye (near the nose) and apply gentle pressure. This will||
0483|040|H|prevent the medication from draining out. Try not to blink and do||
0483|041|H|not rub your eye. Repeat these steps for your other eye if so||
0483|042|H|directed and if your dose is for more than 1 drop.||
0483|043|H|   Do not rinse the dropper. Replace the dropper cap after each||
0483|044|H|use.||
0483|045|H|   If you are using another kind of eye medication (for example,||
0483|046|H|other drops or ointments), wait at least 5 to 10 minutes before||
0483|047|H|applying other medications. Use eye drops before eye ointments to||
0483|048|H|allow the drops to enter the eye.||
0483|049|H|   Wait several minutes for your vision to clear before driving||
0483|050|H|or operating machinery.||
0483|051|H|   Use this medication regularly in order to get the most benefit||
0483|052|H|from it. To help you remember, use it at the same time(s) each||
0483|053|H|day.||
0483|054|H|   The dosage and length of treatment are based on your medical||
0483|055|H|condition and response to treatment. Do not use this medication||
0483|056|H|more often or for longer than prescribed because doing so may||
0483|057|H|increase your risk of side effects.||
0483|058|H|   Continue to use this medication for the full time prescribed.||
0483|059|H|Do not stop using this medication without consulting your doctor.||
0483|060|H|Some conditions may become worse when the drug is suddenly||
0483|061|H|stopped. Your dose may need to be gradually decreased.||
0483|062|H|   Do not use this product if it becomes contaminated (for||
0483|063|H|example, drops turn a dark color). Use of contaminated eye||
0483|064|H|medication can cause infection, serious damage to the eye, and||
0483|065|H|loss of vision. Contact your doctor or pharmacist for more||
0483|066|H|information.||
0483|067|H|   Tell your doctor if your condition does not get better after 2||
0483|068|H|days or if it gets worse.||
0483|069|B|||
0483|070|S|SIDE EFFECTS:  Rarely, stinging/burning of the eyes for 1 to 2||
0483|071|S|minutes may occur when you apply this medication. If any of these||
0483|072|S|effects last or get worse, tell your doctor or pharmacist||
0483|073|S|promptly.||
0483|074|S|   Remember that this medication has been prescribed because your||
0483|075|S|doctor has judged that the benefit to you is greater than the||
0483|076|S|risk of side effects. Many people using this medication do not||
0483|077|S|have serious side effects.||
0483|078|S|   Use of this medication for prolonged periods or in high doses||
0483|079|S|may cause serious eye problems (such as high pressure inside the||
0483|080|S|eyes and cataracts). Tell your doctor right away if any of these||
0483|081|S|serious side effects occur: vision problems, eye pain.||
0483|082|S|   This medication may mask the signs of an eye infection. It may||
0483|083|S|also put you at greater risk of developing an eye infection,||
0483|084|S|especially with prolonged use. Report any new or worsening||
0483|085|S|symptoms such as eye discharge/swelling/redness, vision problems,||
0483|086|S|or no improvement of your current eye condition. Your doctor will||
0483|087|S|need to adjust your treatment.||
0483|088|S|   Tell your doctor right away if you have any serious side||
0483|089|S|effects, including: headache, dizziness.||
0483|090|S|   A very serious allergic reaction to this drug is rare.||
0483|091|S|However, get medical help right away if you notice any symptoms||
0483|092|S|of a serious allergic reaction, including: rash, itching/swelling||
0483|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0483|094|S|breathing.||
0483|095|S|   This is not a complete list of possible side effects. If you||
0483|096|S|notice other effects not listed above, contact your doctor or||
0483|097|S|pharmacist.||
0483|098|S|   In the US -||
0483|099|S|   Call your doctor for medical advice about side effects. You||
0483|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0483|101|S|www.fda.gov/medwatch.||
0483|102|S|   In Canada - Call your doctor for medical advice about side||
0483|103|S|effects. You may report side effects to Health Canada at||
0483|104|S|1-866-234-2345.||
0483|105|B|||
0483|106|P|PRECAUTIONS:  Before using prednisolone, tell your doctor or||
0483|107|P|pharmacist if you are allergic to it; or if you have any other||
0483|108|P|allergies. This product may contain inactive ingredients (such as||
0483|109|P|sulfites found in some brands), which can cause allergic||
0483|110|P|reactions or other problems. Talk to your pharmacist for more||
0483|111|P|details.||
0483|112|P|   Before using this medication, tell your doctor or pharmacist||
0483|113|P|your medical history, especially of: eye infections, recent eye||
0483|114|P|surgery, cataracts, glaucoma (open-angle type), severe||
0483|115|P|nearsightedness (myopia), diabetes.||
0483|116|P|   After you apply this drug, your vision may become temporarily||
0483|117|P|blurred or unstable. Do not drive, use machinery, or do anything||
0483|118|P|that needs clear vision until you can do it safely.||
0483|119|P|   Before having surgery, tell your doctor or dentist about all||
0483|120|P|the products you use (including prescription drugs,||
0483|121|P|nonprescription drugs, and herbal products).||
0483|122|P|   If you develop a new eye infection or injury, or require eye||
0483|123|P|surgery, ask your doctor if you should continue to use your||
0483|124|P|current bottle of prednisolone eye drops or start a new bottle.||
0483|125|P|   During pregnancy, this medication should be used only when||
0483|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
0483|127|P|   It is unknown if this medication passes into breast milk.||
0483|128|P|Consult your doctor before breastfeeding.||
0483|129|B|||
0483|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0483|131|I|medications work or increase your risk for serious side effects.||
0483|132|I|This document does not contain all possible drug interactions.||
0483|133|I|Keep a list of all the products you use (including||
0483|134|I|prescription/nonprescription drugs and herbal products) and share||
0483|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
0483|136|I|the dosage of any medicines without your doctor's approval.||
0483|137|B|||
0483|138|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0483|139|O|has overdosed and has serious symptoms such as passing out or||
0483|140|O|trouble breathing, call 911. Otherwise, call a poison control||
0483|141|O|center right away. US residents can call 1-800-222-1222. Canada||
0483|142|O|residents can call 1-844-764-7669.||
0483|143|B|||
0483|144|N|NOTES:  Do not share this medication with others.||
0483|145|N|   This medication has been prescribed for your current condition||
0483|146|N|only. Do not use it later for another eye condition unless told||
0483|147|N|to do so by your doctor. A different medication may be necessary||
0483|148|N|in that case.||
0483|149|N|   Lab and/or medical tests (such as eye exams, measurement of||
0483|150|N|the pressure inside the eyes) may be done while you are using||
0483|151|N|this medication. Keep all medical and lab appointments. Consult||
0483|152|N|your doctor for more details.||
0483|153|B|||
0483|154|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0483|155|D|If it is near the time of the next dose, skip the missed dose.||
0483|156|D|Use your next dose at the regular time. Do not double the dose to||
0483|157|D|catch up.||
0483|158|B|||
0483|159|R|STORAGE:  Store upright at room temperature away from light. Do||
0483|160|R|not freeze. Keep all medications away from children and pets.||
0483|161|R|   Do not flush medications down the toilet or pour them into a||
0483|162|R|drain unless instructed to do so. Properly discard this product||
0483|163|R|when it is expired or no longer needed. Consult your pharmacist||
0483|164|R|or local waste disposal company.||
0483|165|B|||
0483|166|A|Information last revised October 2024.||
0483|167|A|Copyright(c) 2025 First Databank, Inc.||
0483|168|B|||
0484|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0484|002|Z|does NOT have all possible information about this product. This||
0484|003|Z|information does not assure that this product is safe, effective,||
0484|004|Z|or appropriate for you. This information is not individual||
0484|005|Z|medical advice and does not substitute for the advice of your||
0484|006|Z|health care professional. Always ask your health care||
0484|007|Z|professional for complete information about this product and your||
0484|008|Z|specific health needs.||
0484|009|B|||
0484|010|T|FLUPHENAZINE DECANOATE - INJECTION||
0484|011|F|(flu-FEN-ah-zeen DECK-ah-no-ate)||
0484|012|B|||
0484|013|C|COMMON BRAND NAME(S): Prolixin||
0484|014|B|||
0484|015|W|WARNING:  There may be a slightly increased risk of serious,||
0484|016|W|possibly fatal side effects (such as heart failure,||
0484|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
0484|018|W|by older adults with dementia. This medication is not approved||
0484|019|W|for the treatment of dementia-related behavior problems. Discuss||
0484|020|W|the risks and benefits of this medication, as well as other||
0484|021|W|effective and possibly safer treatments for dementia-related||
0484|022|W|behavior problems, with the doctor.||
0484|023|B|||
0484|024|U|USES:  This medication is used to treat certain mental/mood||
0484|025|U|disorders (such as schizophrenia). Fluphenazine decanoate is a||
0484|026|U|long-acting form of fluphenazine. It may be used by people who||
0484|027|U|have trouble remembering to take medication every day.||
0484|028|U|Fluphenazine belongs to a class of drugs known as antipsychotics.||
0484|029|U|It works by helping to restore the balance of certain natural||
0484|030|U|substances in the brain.||
0484|031|U|   This medication is not recommended for use in children under||
0484|032|U|12 years of age.||
0484|033|B|||
0484|034|H|HOW TO USE:  This medication is given by injection into a muscle||
0484|035|H|or under the skin by a healthcare professional. It is given as||
0484|036|H|directed by your doctor, usually every 4 to 6 weeks. The dosage||
0484|037|H|is based on your medical condition and response to treatment.||
0484|038|H|   Use this medication regularly to get the most benefit from it.||
0484|039|H|To help you remember, mark your calendar with a reminder.||
0484|040|H|   This medication does not work right away. It may take 1 to 3||
0484|041|H|days to notice an effect from this drug, and up to 4 days to get||
0484|042|H|the full effect. For severe agitation or other symptoms, use a||
0484|043|H|short-acting medication as directed by your doctor.||
0484|044|H|   Do not stop using this medication without consulting your||
0484|045|H|doctor. Your condition may become worse if the drug is suddenly||
0484|046|H|stopped. Your dose may need to be gradually decreased.||
0484|047|H|   Tell your doctor if your condition does not get better or if||
0484|048|H|it gets worse.||
0484|049|B|||
0484|050|S|SIDE EFFECTS:  Drowsiness, lethargy, dizziness, lightheadedness,||
0484|051|S|nausea, loss of appetite, sweating, dry mouth, blurred vision,||
0484|052|S|headache, constipation, and pain/redness at the injection site||
0484|053|S|may occur. If any of these effects last or get worse, notify your||
0484|054|S|doctor or pharmacist promptly.||
0484|055|S|   Dizziness and lightheadedness can increase the risk of||
0484|056|S|falling. Get up slowly when rising from a sitting or lying||
0484|057|S|position.||
0484|058|S|   Tell your doctor right away if any of these side effects||
0484|059|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
0484|060|S|mask-like expression of the face, drooling/trouble swallowing, or||
0484|061|S|shuffling walk. Your doctor may prescribe another medication to||
0484|062|S|decrease these side effects.||
0484|063|S|   Remember that this medication has been prescribed because your||
0484|064|S|doctor has judged that the benefit to you is greater than the||
0484|065|S|risk of side effects. Many people using this medication do not||
0484|066|S|have serious side effects.||
0484|067|S|   Tell your doctor right away if you have any serious side||
0484|068|S|effects, including: unusual mental/mood changes (such as||
0484|069|S|depression, confusion, worsening of psychosis), unusual dreams,||
0484|070|S|frequent urination or difficulty urinating, vision problems,||
0484|071|S|weight change, swelling of the feet/ankles, fainting, skin||
0484|072|S|discoloration, butterfly-shaped facial rash, joint pain,||
0484|073|S|seizures.||
0484|074|S|   In rare instances, this medication may increase your level of||
0484|075|S|a certain hormone (prolactin). For females, this rare increase in||
0484|076|S|prolactin may result in unwanted breast milk, missing/stopped||
0484|077|S|menstrual periods, or difficulty becoming pregnant. For males, it||
0484|078|S|may result in decreased sexual ability, inability to produce||
0484|079|S|sperm, or enlarged breasts. If you develop any of these symptoms,||
0484|080|S|tell your doctor right away.||
0484|081|S|   Rarely, males may have a painful or prolonged erection lasting||
0484|082|S|4 or more hours. If this occurs, stop using this drug and get||
0484|083|S|medical help right away, or permanent problems could occur.||
0484|084|S|   Fluphenazine may rarely cause a condition known as tardive||
0484|085|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0484|086|S|your doctor right away if you develop any unusual/uncontrolled||
0484|087|S|movements (especially of the face, mouth, tongue, arms, or legs).||
0484|088|S|   This medication may rarely cause a very serious condition||
0484|089|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0484|090|S|right away if you have any of the following symptoms: fever,||
0484|091|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
0484|092|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
0484|093|S|signs of kidney problems (such as change in the amount of urine).||
0484|094|S|   This drug may rarely cause serious blood problems (such as||
0484|095|S|agranulocytosis, leukopenia) or liver problems. Get medical help||
0484|096|S|right away if you notice any of the following rare but very||
0484|097|S|serious side effects: signs of infection (such as sore throat||
0484|098|S|that doesn't go away, fever, chills), easy bruising/bleeding,||
0484|099|S|severe stomach/abdominal pain, yellowing of the eyes/skin.||
0484|100|S|   A very serious allergic reaction to this drug is rare.||
0484|101|S|However, get medical help right away if you notice any symptoms||
0484|102|S|of a serious allergic reaction, including: rash, itching/swelling||
0484|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0484|104|S|breathing.||
0484|105|S|   This is not a complete list of possible side effects. If you||
0484|106|S|notice other effects not listed above, contact your doctor or||
0484|107|S|pharmacist.||
0484|108|S|   In the US -||
0484|109|S|   Call your doctor for medical advice about side effects. You||
0484|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0484|111|S|www.fda.gov/medwatch.||
0484|112|S|   In Canada - Call your doctor for medical advice about side||
0484|113|S|effects. You may report side effects to Health Canada at||
0484|114|S|1-866-234-2345.||
0484|115|B|||
0484|116|P|PRECAUTIONS:  Before using fluphenazine decanoate, tell your||
0484|117|P|doctor or pharmacist if you are allergic to it; or to other||
0484|118|P|phenothiazines (such as chlorpromazine, perphenazine); or if you||
0484|119|P|have any other allergies. This product may contain inactive||
0484|120|P|ingredients (such as sesame oil, benzyl alcohol), which can cause||
0484|121|P|allergic reactions or other problems. Talk to your pharmacist for||
0484|122|P|more details.||
0484|123|P|   Before using this medication, tell your doctor or pharmacist||
0484|124|P|your medical history, especially of: brain damage, nervous system||
0484|125|P|problems (such as CNS depression, cerebrovascular insufficiency,||
0484|126|P|brain tumors, encephalitis, encephalopathy), blood problems (such||
0484|127|P|as leukopenia, thrombocytopenia, agranulocytosis), liver||
0484|128|P|problems, breast cancer, eye problems (such as glaucoma), heart||
0484|129|P|problems (such as very high or very low blood pressure, mitral||
0484|130|P|valve insufficiency), kidney problems, a certain adrenal gland||
0484|131|P|tumor (pheochromocytoma), seizures, exposure to phosphorus||
0484|132|P|insecticides, chronic breathing problems (such as asthma,||
0484|133|P|emphysema, frequent infections), low blood calcium, enlarged||
0484|134|P|prostate, drug or alcohol dependency, Reye's syndrome,||
0484|135|P|dehydration.||
0484|136|P|   Before having surgery or any diagnostic testing, tell your||
0484|137|P|doctor or dentist about all the products you use (including||
0484|138|P|prescription drugs, nonprescription drugs, and herbal products).||
0484|139|P|   This drug may make you dizzy or drowsy or blur your vision.||
0484|140|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0484|141|P|drowsy. Do not drive, use machinery, or do anything that needs||
0484|142|P|alertness or clear vision until you can do it safely. Avoid||
0484|143|P|alcoholic beverages. Talk to your doctor if you are using||
0484|144|P|marijuana (cannabis).||
0484|145|P|   This medication may make you more sensitive to the sun. Limit||
0484|146|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0484|147|P|sunscreen and wear protective clothing when outdoors. Tell your||
0484|148|P|doctor right away if you get sunburned or have skin||
0484|149|P|blisters/redness.||
0484|150|P|   This medication may make you sweat less, making you more||
0484|151|P|likely to get heat stroke. Avoid doing things that may cause you||
0484|152|P|to overheat, such as hard work or exercise in hot weather, or||
0484|153|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0484|154|P|and dress lightly. If you overheat, quickly look for a place to||
0484|155|P|cool down and rest. Get medical help right away if you have a||
0484|156|P|fever that does not go away, mental/mood changes, headache, or||
0484|157|P|dizziness.||
0484|158|P|   Avoid being exposed to very cold temperatures (such as||
0484|159|P|swimming in cold water). Severe lowering of your body temperature||
0484|160|P|may occur.||
0484|161|P|   Children may be more sensitive to the side effects of this||
0484|162|P|drug, especially the side effect of uncontrolled movements. This||
0484|163|P|is especially true if the child is sick (such as has chickenpox,||
0484|164|P|measles, stomach flu).||
0484|165|P|   Older adults may be more sensitive to the side effects of this||
0484|166|P|drug, especially pain at the injection site, facial or muscle||
0484|167|P|twitching, muscle spasms/stiffness, uncontrolled movements||
0484|168|P|(tardive dyskinesia), drowsiness, dizziness, lightheadedness,||
0484|169|P|confusion, and possible effects on blood pressure. Drowsiness,||
0484|170|P|dizziness, lightheadedness, and confusion can increase the risk||
0484|171|P|of falling.||
0484|172|P|   During pregnancy, this medication should be used only when||
0484|173|P|clearly needed. Liver problems or birth defects may occur in||
0484|174|P|infants exposed to this type of medication in the womb. Tell the||
0484|175|P|doctor right away if you notice yellowing of the eyes/skin or||
0484|176|P|dark urine in your infant. Babies born to mothers who have used||
0484|177|P|this drug during the last 3 months of pregnancy may rarely||
0484|178|P|develop symptoms including muscle stiffness or shakiness,||
0484|179|P|drowsiness, feeding/breathing difficulties, or constant crying.||
0484|180|P|If you notice any of these symptoms in your newborn especially||
0484|181|P|during their first month, tell the doctor right away.||
0484|182|P|   Since untreated mental/mood problems (such as schizophrenia)||
0484|183|P|can be a serious condition, do not stop taking this medication||
0484|184|P|unless directed by your doctor. If you are planning pregnancy,||
0484|185|P|become pregnant, or think you may be pregnant, immediately||
0484|186|P|discuss with your doctor the benefits and risks of using this||
0484|187|P|medication during pregnancy.||
0484|188|P|   It is unknown if this medication passes into breast milk.||
0484|189|P|However, similar drugs pass into breast milk. Consult your doctor||
0484|190|P|before breastfeeding.||
0484|191|B|||
0484|192|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0484|193|I|medications work or increase your risk for serious side effects.||
0484|194|I|This document does not contain all possible drug interactions.||
0484|195|I|Keep a list of all the products you use (including||
0484|196|I|prescription/nonprescription drugs and herbal products) and share||
0484|197|I|it with your doctor and pharmacist. Do not start, stop, or change||
0484|198|I|the dosage of any medicines without your doctor's approval.||
0484|199|I|   Some products that may interact with this drug are: guanadrel,||
0484|200|I|guanethidine, lithium.||
0484|201|I|   Tell your doctor or pharmacist if you are taking other||
0484|202|I|products that cause drowsiness such as opioid pain or cough||
0484|203|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0484|204|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0484|205|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0484|206|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0484|207|I|diphenhydramine).||
0484|208|I|   Check the labels on all your medicines (such as allergy or||
0484|209|I|cough-and-cold products) because they may contain ingredients||
0484|210|I|that cause drowsiness. Ask your pharmacist about using those||
0484|211|I|products safely.||
0484|212|I|   This medication may interfere with certain lab tests (such as||
0484|213|I|pregnancy test, phenylketonuria test, some urine tests), possibly||
0484|214|I|causing false test results. Make sure lab personnel and all your||
0484|215|I|doctors know you use this drug.||
0484|216|B|||
0484|217|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0484|218|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0484|219|O|poison control center right away. US residents can call||
0484|220|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0484|221|O|Symptoms of overdose may include: loss of consciousness,||
0484|222|O|seizures, fast/irregular heartbeat, or slow/shallow breathing.||
0484|223|B|||
0484|224|N|NOTES:  Do not share this medication with others.||
0484|225|N|   Lab and/or medical tests (such as liver/kidney function,||
0484|226|N|complete blood counts, eye exams, AIMS test) should be done while||
0484|227|N|you are using this medication. Keep all medical and lab||
0484|228|N|appointments. Consult your doctor for more details.||
0484|229|B|||
0484|230|D|MISSED DOSE:  It is important to get each dose of this medication||
0484|231|D|as scheduled. If you miss an injection, ask your doctor or||
0484|232|D|pharmacist right away for a new dosing schedule. Do not double||
0484|233|D|the dose to catch up.||
0484|234|B|||
0484|235|R|STORAGE:  Not applicable. This medication is given in a clinic or||
0484|236|R|doctor's office and will not be stored at home.||
0484|237|B|||
0484|238|M|MEDICAL ALERT:  Your condition can cause complications in a||
0484|239|M|medical emergency. For information about enrolling in MedicAlert,||
0484|240|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0484|241|B|||
0484|242|A|Information last revised April 2025.||
0484|243|A|Copyright(c) 2025 First Databank, Inc.||
0484|244|B|||
0485|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0485|002|Z|does NOT have all possible information about this product. This||
0485|003|Z|information does not assure that this product is safe, effective,||
0485|004|Z|or appropriate for you. This information is not individual||
0485|005|Z|medical advice and does not substitute for the advice of your||
0485|006|Z|health care professional. Always ask your health care||
0485|007|Z|professional for complete information about this product and your||
0485|008|Z|specific health needs.||
0485|009|B|||
0485|010|T|TEMAZEPAM - ORAL||
0485|011|F|(teh-MAZ-eh-pam)||
0485|012|B|||
0485|013|C|COMMON BRAND NAME(S): Restoril||
0485|014|B|||
0485|015|W|WARNING:  Temazepam has a risk for abuse and addiction, which can||
0485|016|W|lead to overdose and death. Taking this medication with alcohol||
0485|017|W|or other drugs that can cause drowsiness or breathing problems||
0485|018|W|(especially opioid medications such as codeine, hydrocodone) may||
0485|019|W|cause very serious side effects, including death. To lower your||
0485|020|W|risk, your doctor should have you take the smallest dose of||
0485|021|W|temazepam that works, and take it for the shortest possible time.||
0485|022|W|Be sure you know how to take temazepam and what other drugs you||
0485|023|W|should avoid taking with it. See also Drug Interactions section.||
0485|024|W|Get medical help right away if any of these very serious side||
0485|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
0485|026|W|severe drowsiness/dizziness, difficulty waking up.||
0485|027|W|   Suddenly stopping this medication may cause serious (possibly||
0485|028|W|fatal) withdrawal, especially if you have used it for a long time||
0485|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
0485|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
0485|031|W|you have any withdrawal symptoms such as headaches, restlessness,||
0485|032|W|hallucinations/confusion, depression, nausea, or seizures.||
0485|033|W|Withdrawal symptoms may sometimes last weeks to months.||
0485|034|B|||
0485|035|U|USES:  This medication is used to treat a certain sleep problem||
0485|036|U|(insomnia). It may help you fall asleep faster, stay asleep||
0485|037|U|longer, and lessen how often you wake up during the night, so you||
0485|038|U|can get a better night's rest. Temazepam belongs to a class of||
0485|039|U|drugs called benzodiazepines. It acts on your brain to produce a||
0485|040|U|calming effect.||
0485|041|U|   Use of this medication is usually limited to short treatment||
0485|042|U|periods of 1 to 2 weeks or less. If your insomnia continues for a||
0485|043|U|longer time, talk to your doctor to see if you need other||
0485|044|U|treatment.||
0485|045|B|||
0485|046|H|HOW TO USE:  See also Warning section.||
0485|047|H|   Read the Medication Guide provided by your pharmacist before||
0485|048|H|you start using temazepam and each time you get a refill. If you||
0485|049|H|have any questions, ask your doctor or pharmacist.||
0485|050|H|   Take this medication by mouth with or without food as directed||
0485|051|H|by your doctor, usually just before you get into bed. The dosage||
0485|052|H|is based on your medical condition, age, and response to||
0485|053|H|treatment.||
0485|054|H|   Although unlikely, this drug can rarely cause temporary||
0485|055|H|short-term memory loss. To lessen the chance of this, do not take||
0485|056|H|a dose of this drug unless you have time for a full night's sleep||
0485|057|H|of at least 7 to 8 hours. If you have to wake up before that, you||
0485|058|H|may have some memory loss.||
0485|059|H|   When this medication is used for a long time, it may not work||
0485|060|H|as well. Talk with your doctor if this medication stops working||
0485|061|H|well.||
0485|062|H|   Though it helps many people, this medication may sometimes||
0485|063|H|cause addiction. This risk may be higher if you have a substance||
0485|064|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0485|065|H|Take this medication exactly as prescribed to lower the risk of||
0485|066|H|addiction. Ask your doctor or pharmacist for more details.||
0485|067|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
0485|068|H|or if it gets worse.||
0485|069|H|   You may have trouble sleeping the first few nights after you||
0485|070|H|stop taking this medication. This is called rebound insomnia and||
0485|071|H|is normal. It will usually go away after 1 or 2 nights. If this||
0485|072|H|effect continues, contact your doctor.||
0485|073|B|||
0485|074|S|SIDE EFFECTS:  See also Warning section.||
0485|075|S|   Dizziness or difficulty with coordination may occur. If either||
0485|076|S|of these effects lasts or gets worse, tell your doctor or||
0485|077|S|pharmacist promptly. To reduce the risk of dizziness or falling,||
0485|078|S|get up slowly when rising from a sitting or lying position.||
0485|079|S|   This medication may make you sleepy during the day. Tell your||
0485|080|S|doctor if you have daytime drowsiness. Your dose may need to be||
0485|081|S|adjusted.||
0485|082|S|   Remember that this medication has been prescribed because your||
0485|083|S|doctor has judged that the benefit to you is greater than the||
0485|084|S|risk of side effects. Many people using this medication do not||
0485|085|S|have serious side effects.||
0485|086|S|   Tell your doctor right away if you have any serious side||
0485|087|S|effects, including: memory loss, mental/mood/behavior changes||
0485|088|S|(such as new/worsening depression, abnormal thoughts, thoughts of||
0485|089|S|suicide, hallucinations, confusion, agitation, aggressive||
0485|090|S|behavior, anxiety).||
0485|091|S|   Rarely, after taking this drug, people have gotten out of bed||
0485|092|S|and driven vehicles while not fully awake ("sleep-driving").||
0485|093|S|People have also sleepwalked, prepared/eaten food, made phone||
0485|094|S|calls, or had sex while not fully awake. Often, these people do||
0485|095|S|not remember these events. This problem can be dangerous to you||
0485|096|S|or to others. If you find out that you have done any of these||
0485|097|S|activities after taking this medication, tell your doctor right||
0485|098|S|away. Your risk is increased if you use alcohol or other||
0485|099|S|medications that can make you drowsy while taking temazepam.||
0485|100|S|   A very serious allergic reaction to this drug is rare.||
0485|101|S|However, get medical help right away if you notice any symptoms||
0485|102|S|of a serious allergic reaction, including: rash, itching/swelling||
0485|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0485|104|S|breathing.||
0485|105|S|   This is not a complete list of possible side effects. If you||
0485|106|S|notice other effects not listed above, contact your doctor or||
0485|107|S|pharmacist.||
0485|108|S|   In the US -||
0485|109|S|   Call your doctor for medical advice about side effects. You||
0485|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0485|111|S|www.fda.gov/medwatch.||
0485|112|S|   In Canada - Call your doctor for medical advice about side||
0485|113|S|effects. You may report side effects to Health Canada at||
0485|114|S|1-866-234-2345.||
0485|115|B|||
0485|116|P|PRECAUTIONS:  Before taking temazepam, tell your doctor or||
0485|117|P|pharmacist if you are allergic to it; or to other benzodiazepines||
0485|118|P|(such as diazepam, oxazepam); or if you have any other allergies.||
0485|119|P|This product may contain inactive ingredients, which can cause||
0485|120|P|allergic reactions or other problems. Talk to your pharmacist for||
0485|121|P|more details.||
0485|122|P|   Before using this medication, tell your doctor or pharmacist||
0485|123|P|your medical history, especially of: kidney disease, liver||
0485|124|P|disease, lung/breathing problems (such as chronic obstructive||
0485|125|P|pulmonary disease-COPD, sleep apnea), mental/mood problems (such||
0485|126|P|as depression, thoughts of suicide), personal or family history||
0485|127|P|of a substance use disorder (such as overuse of or addiction to||
0485|128|P|drugs/alcohol), personal or family history of sleepwalking, a||
0485|129|P|certain muscle disease (myasthenia gravis).||
0485|130|P|   Since this drug makes you drowsy, do not drive, use machinery,||
0485|131|P|or do anything that needs alertness until you can do it safely.||
0485|132|P|Alcohol or marijuana (cannabis) can make you more drowsy. Avoid||
0485|133|P|alcoholic beverages. Talk to your doctor if you are using||
0485|134|P|marijuana (cannabis).||
0485|135|P|   Before having surgery, tell your doctor or dentist about all||
0485|136|P|the products you use (including prescription drugs,||
0485|137|P|nonprescription drugs, and herbal products).||
0485|138|P|   Older adults may be more sensitive to the side effects of this||
0485|139|P|drug, especially dizziness, confusion, unsteadiness, and||
0485|140|P|excessive drowsiness. These side effects can increase the risk of||
0485|141|P|falling.||
0485|142|P|   Tell your doctor if you are pregnant or plan to become||
0485|143|P|pregnant. You should not become pregnant while using temazepam.||
0485|144|P|Temazepam may harm an unborn baby. Newborn babies of mothers who||
0485|145|P|use this medication late in pregnancy may have symptoms such as||
0485|146|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
0485|147|P|feeding. If you become pregnant, talk to your doctor right away||
0485|148|P|about the risks and benefits of this medication.||
0485|149|P|   This medication passes into breast milk and may have||
0485|150|P|undesirable effects on a nursing infant. Consult your doctor||
0485|151|P|before breastfeeding.||
0485|152|B|||
0485|153|I|DRUG INTERACTIONS:  See also Warning section.||
0485|154|I|   Drug interactions may change how your medications work or||
0485|155|I|increase your risk for serious side effects. This document does||
0485|156|I|not contain all possible drug interactions. Keep a list of all||
0485|157|I|the products you use (including prescription/nonprescription||
0485|158|I|drugs and herbal products) and share it with your doctor and||
0485|159|I|pharmacist. Do not start, stop, or change the dosage of any||
0485|160|I|medicines without your doctor's approval.||
0485|161|I|   A product that may interact with this drug is: sodium oxybate.||
0485|162|I|   The risk of serious side effects (such as slow/shallow||
0485|163|I|breathing, severe drowsiness/dizziness) may be increased if this||
0485|164|I|medication is taken with other products that may also cause||
0485|165|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0485|166|I|if you are taking other products such as opioid pain or cough||
0485|167|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0485|168|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0485|169|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0485|170|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0485|171|I|diphenhydramine).||
0485|172|I|   Check the labels on all your medicines (such as allergy or||
0485|173|I|cough-and-cold products) because they may contain ingredients||
0485|174|I|that cause drowsiness. Ask your pharmacist about using those||
0485|175|I|products safely.||
0485|176|B|||
0485|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0485|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0485|179|O|poison control center right away. US residents can call||
0485|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0485|181|O|Symptoms of overdose may include slowed breathing or a deep sleep||
0485|182|O|from which you cannot be awakened.||
0485|183|B|||
0485|184|N|NOTES:  Do not share this medication with others. Sharing it is||
0485|185|N|against the law.||
0485|186|N|   As you get older, your sleep pattern may naturally change and||
0485|187|N|your sleep may be interrupted several times during the night.||
0485|188|N|Consult your doctor or pharmacist for ways to improve your sleep||
0485|189|N|without medication, such as avoiding caffeine and alcohol close||
0485|190|N|to bedtime, avoiding daytime naps, and going to bed at the same||
0485|191|N|time each night.||
0485|192|B|||
0485|193|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
0485|194|D|time to sleep for 7 to 8 hours afterward. (See also How to Use||
0485|195|D|section.)||
0485|196|B|||
0485|197|R|STORAGE:  Store at room temperature away from light and moisture.||
0485|198|R|Do not store in the bathroom. Keep all medications away from||
0485|199|R|children and pets.||
0485|200|R|   Do not flush medications down the toilet or pour them into a||
0485|201|R|drain unless instructed to do so. Properly discard this product||
0485|202|R|when it is expired or no longer needed. Consult your pharmacist||
0485|203|R|or local waste disposal company.||
0485|204|B|||
0485|205|A|Information last revised May 2024.||
0485|206|A|Copyright(c) 2025 First Databank, Inc.||
0485|207|B|||
0486|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0486|002|Z|does NOT have all possible information about this product. This||
0486|003|Z|information does not assure that this product is safe, effective,||
0486|004|Z|or appropriate for you. This information is not individual||
0486|005|Z|medical advice and does not substitute for the advice of your||
0486|006|Z|health care professional. Always ask your health care||
0486|007|Z|professional for complete information about this product and your||
0486|008|Z|specific health needs.||
0486|009|B|||
0486|010|T|TRIAZOLAM - ORAL||
0486|011|F|(tri-AH-zoe-lam)||
0486|012|B|||
0486|013|C|COMMON BRAND NAME(S): Halcion||
0486|014|B|||
0486|015|W|WARNING:  Triazolam has a risk for abuse and addiction, which can||
0486|016|W|lead to overdose and death. Taking this medication with alcohol||
0486|017|W|or other drugs that can cause drowsiness or breathing problems||
0486|018|W|(especially opioid medications such as codeine, hydrocodone) may||
0486|019|W|cause very serious side effects, including death. To lower your||
0486|020|W|risk, your doctor should have you take the smallest dose of||
0486|021|W|triazolam that works, and take it for the shortest possible time.||
0486|022|W|Be sure you know how to take triazolam and what other drugs you||
0486|023|W|should avoid taking with it. See also Drug Interactions section.||
0486|024|W|Get medical help right away if any of these very serious side||
0486|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
0486|026|W|severe drowsiness/dizziness, difficulty waking up.||
0486|027|W|   Suddenly stopping this medication may cause serious (possibly||
0486|028|W|fatal) withdrawal, especially if you have used it for a long time||
0486|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
0486|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
0486|031|W|you have any withdrawal symptoms such as headaches, restlessness,||
0486|032|W|hallucinations/confusion, depression, nausea, or seizures.||
0486|033|W|Withdrawal symptoms may sometimes last weeks to months.||
0486|034|B|||
0486|035|U|USES:  This medication is used to treat a certain sleep problem||
0486|036|U|(insomnia). It may help you fall asleep faster, stay asleep||
0486|037|U|longer, and lessen how often you wake up during the night, so you||
0486|038|U|can get a better night's rest. Triazolam belongs to a class of||
0486|039|U|drugs called benzodiazepines. It acts on your brain to produce a||
0486|040|U|calming effect.||
0486|041|U|   Use of this medication is usually limited to short treatment||
0486|042|U|periods of 1 to 2 weeks or less. If your insomnia continues for a||
0486|043|U|longer time, talk to your doctor to see if you need other||
0486|044|U|treatment.||
0486|045|B|||
0486|046|H|HOW TO USE:  See also Warning section.||
0486|047|H|   Read the Medication Guide provided by your pharmacist before||
0486|048|H|you start using triazolam and each time you get a refill. If you||
0486|049|H|have any questions, ask your doctor or pharmacist.||
0486|050|H|   Take this medication by mouth with or without food as directed||
0486|051|H|by your doctor, usually just before you get into bed. The dosage||
0486|052|H|is based on your medical condition, age, and response to||
0486|053|H|treatment.||
0486|054|H|   Although unlikely, this drug can rarely cause temporary||
0486|055|H|short-term memory loss. To lessen the chance of this, do not take||
0486|056|H|a dose of this drug unless you have time for a full night's sleep||
0486|057|H|of at least 7 to 8 hours. If you have to wake up before that, you||
0486|058|H|may have some memory loss.||
0486|059|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0486|060|H|using this medication unless your doctor or pharmacist says you||
0486|061|H|may do so safely. Grapefruit can increase the chance of side||
0486|062|H|effects with this medicine. Ask your doctor or pharmacist for||
0486|063|H|more details.||
0486|064|H|   When this medication is used for a long time, it may not work||
0486|065|H|as well. Talk with your doctor if this medication stops working||
0486|066|H|well.||
0486|067|H|   Though it helps many people, this medication may sometimes||
0486|068|H|cause addiction. This risk may be higher if you have a substance||
0486|069|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0486|070|H|Take this medication exactly as prescribed to lower the risk of||
0486|071|H|addiction. Ask your doctor or pharmacist for more details.||
0486|072|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
0486|073|H|or if it gets worse.||
0486|074|H|   You may have trouble sleeping the first few nights after you||
0486|075|H|stop taking this medication. This is called rebound insomnia and||
0486|076|H|is normal. It will usually go away after 1 or 2 nights. If this||
0486|077|H|effect continues, contact your doctor.||
0486|078|B|||
0486|079|S|SIDE EFFECTS:  See also Warning section.||
0486|080|S|   Dizziness or difficulty with coordination may occur. If either||
0486|081|S|of these effects lasts or gets worse, tell your doctor or||
0486|082|S|pharmacist promptly. To reduce the risk of dizziness or falling,||
0486|083|S|get up slowly when rising from a sitting or lying position.||
0486|084|S|   This medication may make you sleepy during the day. Tell your||
0486|085|S|doctor if you have daytime drowsiness. Your dose may need to be||
0486|086|S|adjusted.||
0486|087|S|   Remember that this medication has been prescribed because your||
0486|088|S|doctor has judged that the benefit to you is greater than the||
0486|089|S|risk of side effects. Many people using this medication do not||
0486|090|S|have serious side effects.||
0486|091|S|   Tell your doctor right away if you have any serious side||
0486|092|S|effects, including: memory loss, mental/mood/behavior changes||
0486|093|S|(such as new/worsening depression, abnormal thoughts, thoughts of||
0486|094|S|suicide, hallucinations, confusion, agitation, aggressive||
0486|095|S|behavior, anxiety).||
0486|096|S|   Rarely, after taking this drug, people have gotten out of bed||
0486|097|S|and driven vehicles while not fully awake ("sleep-driving").||
0486|098|S|People have also sleepwalked, prepared/eaten food, made phone||
0486|099|S|calls, or had sex while not fully awake. Often, these people do||
0486|100|S|not remember these events. This problem can be dangerous to you||
0486|101|S|or to others. If you find out that you have done any of these||
0486|102|S|activities after taking this medication, tell your doctor right||
0486|103|S|away. Your risk is increased if you use alcohol or other||
0486|104|S|medications that can make you drowsy while taking triazolam.||
0486|105|S|   A very serious allergic reaction to this drug is rare.||
0486|106|S|However, get medical help right away if you notice any symptoms||
0486|107|S|of a serious allergic reaction, including: rash, itching/swelling||
0486|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0486|109|S|breathing.||
0486|110|S|   This is not a complete list of possible side effects. If you||
0486|111|S|notice other effects not listed above, contact your doctor or||
0486|112|S|pharmacist.||
0486|113|S|   In the US -||
0486|114|S|   Call your doctor for medical advice about side effects. You||
0486|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0486|116|S|www.fda.gov/medwatch.||
0486|117|S|   In Canada - Call your doctor for medical advice about side||
0486|118|S|effects. You may report side effects to Health Canada at||
0486|119|S|1-866-234-2345.||
0486|120|B|||
0486|121|P|PRECAUTIONS:  Before taking triazolam, tell your doctor or||
0486|122|P|pharmacist if you are allergic to it; or to other benzodiazepines||
0486|123|P|(such as diazepam, lorazepam); or if you have any other||
0486|124|P|allergies. This product may contain inactive ingredients, which||
0486|125|P|can cause allergic reactions or other problems. Talk to your||
0486|126|P|pharmacist for more details.||
0486|127|P|   Before using this medication, tell your doctor or pharmacist||
0486|128|P|your medical history, especially of: kidney disease, liver||
0486|129|P|disease, lung/breathing problems (such as chronic obstructive||
0486|130|P|pulmonary disease-COPD, sleep apnea), mental/mood problems (such||
0486|131|P|as depression, thoughts of suicide), personal or family history||
0486|132|P|of a substance use disorder (such as overuse of or addiction to||
0486|133|P|drugs/alcohol), personal or family history of sleepwalking, a||
0486|134|P|certain muscle disease (myasthenia gravis).||
0486|135|P|   Since this drug makes you drowsy, do not drive, use machinery,||
0486|136|P|or do anything that needs alertness until you can do it safely.||
0486|137|P|Alcohol or marijuana (cannabis) can make you more drowsy. Avoid||
0486|138|P|alcoholic beverages. Talk to your doctor if you are using||
0486|139|P|marijuana (cannabis).||
0486|140|P|   Before having surgery, tell your doctor or dentist about all||
0486|141|P|the products you use (including prescription drugs,||
0486|142|P|nonprescription drugs, and herbal products).||
0486|143|P|   Older adults may be more sensitive to the side effects of this||
0486|144|P|drug, especially dizziness, confusion, unsteadiness, and||
0486|145|P|excessive drowsiness. These side effects can increase the risk of||
0486|146|P|falling.||
0486|147|P|   Tell your doctor if you are pregnant or plan to become||
0486|148|P|pregnant. You should not become pregnant while using triazolam.||
0486|149|P|Triazolam may harm an unborn baby. Newborn babies of mothers who||
0486|150|P|use this medication late in pregnancy may have symptoms such as||
0486|151|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
0486|152|P|feeding. If you become pregnant, talk to your doctor right away||
0486|153|P|about the risks and benefits of this medication.||
0486|154|P|   This medication may pass into breast milk and have undesirable||
0486|155|P|effects on a nursing infant. Consult your doctor before||
0486|156|P|breastfeeding.||
0486|157|B|||
0486|158|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
0486|159|I|   Drug interactions may change how your medications work or||
0486|160|I|increase your risk for serious side effects. This document does||
0486|161|I|not contain all possible drug interactions. Keep a list of all||
0486|162|I|the products you use (including prescription/nonprescription||
0486|163|I|drugs and herbal products) and share it with your doctor and||
0486|164|I|pharmacist. Do not start, stop, or change the dosage of any||
0486|165|I|medicines without your doctor's approval.||
0486|166|I|   A product that may interact with this drug is: sodium oxybate.||
0486|167|I|   Other medications can affect the removal of triazolam from||
0486|168|I|your body, which may affect how triazolam works. Examples include||
0486|169|I|mifepristone, ritonavir, St John's wort, certain antidepressants||
0486|170|I|(such as nefazodone, SSRIs such as fluoxetine/paroxetine), azole||
0486|171|I|antifungals (such as itraconazole, ketoconazole), macrolide||
0486|172|I|antibiotics (such as erythromycin, clarithromycin), HIV protease||
0486|173|I|inhibitors (such as lopinavir), rifamycins (such as rifampin,||
0486|174|I|rifabutin), among others.||
0486|175|I|   The risk of serious side effects (such as slow/shallow||
0486|176|I|breathing, severe drowsiness/dizziness) may be increased if this||
0486|177|I|medication is taken with other products that may also cause||
0486|178|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0486|179|I|if you are taking other products such as opioid pain or cough||
0486|180|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0486|181|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0486|182|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0486|183|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0486|184|I|diphenhydramine).||
0486|185|I|   Check the labels on all your medicines (such as allergy or||
0486|186|I|cough-and-cold products) because they may contain ingredients||
0486|187|I|that cause drowsiness. Ask your pharmacist about using those||
0486|188|I|products safely.||
0486|189|B|||
0486|190|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0486|191|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0486|192|O|poison control center right away. US residents can call||
0486|193|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0486|194|O|Symptoms of overdose may include slowed breathing or a deep sleep||
0486|195|O|from which you cannot be awakened.||
0486|196|B|||
0486|197|N|NOTES:  Do not share this medication with others. Sharing it is||
0486|198|N|against the law.||
0486|199|N|   As you get older, your sleep pattern may naturally change and||
0486|200|N|your sleep may be interrupted several times during the night.||
0486|201|N|Consult your doctor or pharmacist for ways to improve your sleep||
0486|202|N|without medication, such as avoiding caffeine and alcohol close||
0486|203|N|to bedtime, avoiding daytime naps, and going to bed at the same||
0486|204|N|time each night.||
0486|205|B|||
0486|206|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
0486|207|D|time to sleep for 7 to 8 hours afterward. (See also How to Use||
0486|208|D|section.)||
0486|209|B|||
0486|210|R|STORAGE:  Store at room temperature away from light and moisture.||
0486|211|R|Do not store in the bathroom. Keep all medications away from||
0486|212|R|children and pets.||
0486|213|R|   Do not flush medications down the toilet or pour them into a||
0486|214|R|drain unless instructed to do so. Properly discard this product||
0486|215|R|when it is expired or no longer needed. Consult your pharmacist||
0486|216|R|or local waste disposal company.||
0486|217|B|||
0486|218|A|Information last revised May 2024.||
0486|219|A|Copyright(c) 2025 First Databank, Inc.||
0486|220|B|||
0487|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0487|002|Z|does NOT have all possible information about this product. This||
0487|003|Z|information does not assure that this product is safe, effective,||
0487|004|Z|or appropriate for you. This information is not individual||
0487|005|Z|medical advice and does not substitute for the advice of your||
0487|006|Z|health care professional. Always ask your health care||
0487|007|Z|professional for complete information about this product and your||
0487|008|Z|specific health needs.||
0487|009|B|||
0487|010|T|ESTAZOLAM - ORAL||
0487|011|F|(es-TAH-zoe-lam)||
0487|012|B|||
0487|013|C|COMMON BRAND NAME(S): Prosom||
0487|014|B|||
0487|015|W|WARNING:  Estazolam has a risk for abuse and addiction, which can||
0487|016|W|lead to overdose and death. Taking this medication with alcohol||
0487|017|W|or other drugs that can cause drowsiness or breathing problems||
0487|018|W|(especially opioid medications such as codeine, hydrocodone) may||
0487|019|W|cause very serious side effects, including death. To lower your||
0487|020|W|risk, your doctor should have you take the smallest dose of||
0487|021|W|estazolam that works, and take it for the shortest possible time.||
0487|022|W|Be sure you know how to take estazolam and what other drugs you||
0487|023|W|should avoid taking with it. See also Drug Interactions section.||
0487|024|W|Get medical help right away if any of these very serious side||
0487|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
0487|026|W|severe drowsiness/dizziness, difficulty waking up.||
0487|027|W|   Suddenly stopping this medication may cause serious (possibly||
0487|028|W|fatal) withdrawal, especially if you have used it for a long time||
0487|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
0487|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
0487|031|W|you have any withdrawal symptoms such as headaches, restlessness,||
0487|032|W|hallucinations/confusion, depression, nausea, or seizures.||
0487|033|W|Withdrawal symptoms may sometimes last weeks to months.||
0487|034|B|||
0487|035|U|USES:  This medication is used to treat a certain sleep problem||
0487|036|U|(insomnia). It may help you fall asleep faster, stay asleep||
0487|037|U|longer, and lessen how often you wake up during the night, so you||
0487|038|U|can get a better night's rest. Estazolam belongs to a class of||
0487|039|U|drugs called benzodiazepines. It acts on your brain to produce a||
0487|040|U|calming effect.||
0487|041|U|   Use of this medication is usually limited to short treatment||
0487|042|U|periods of 1 to 2 weeks or less. If your insomnia continues for a||
0487|043|U|longer time, talk to your doctor to see if you need other||
0487|044|U|treatment.||
0487|045|B|||
0487|046|H|HOW TO USE:  See also Warning section.||
0487|047|H|   Read the Medication Guide provided by your pharmacist before||
0487|048|H|you start using estazolam and each time you get a refill. If you||
0487|049|H|have any questions, ask your doctor or pharmacist.||
0487|050|H|   Take this medication by mouth with or without food as directed||
0487|051|H|by your doctor, usually just before you get into bed. The dosage||
0487|052|H|is based on your medical condition, age, and response to||
0487|053|H|treatment.||
0487|054|H|   Although unlikely, this drug can rarely cause temporary||
0487|055|H|short-term memory loss. To lessen the chance of this, do not take||
0487|056|H|a dose of this drug unless you have time for a full night's sleep||
0487|057|H|of at least 7 to 8 hours. If you have to wake up before that, you||
0487|058|H|may have some memory loss.||
0487|059|H|   When this medication is used for a long time, it may not work||
0487|060|H|as well. Talk with your doctor if this medication stops working||
0487|061|H|well.||
0487|062|H|   Though it helps many people, this medication may sometimes||
0487|063|H|cause addiction. This risk may be higher if you have a substance||
0487|064|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0487|065|H|Take this medication exactly as prescribed to lower the risk of||
0487|066|H|addiction. Ask your doctor or pharmacist for more details.||
0487|067|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
0487|068|H|or if it gets worse.||
0487|069|H|   You may have trouble sleeping the first few nights after you||
0487|070|H|stop taking this medication. This is called rebound insomnia and||
0487|071|H|is normal. It will usually go away after 1 or 2 nights. If this||
0487|072|H|effect continues, contact your doctor.||
0487|073|B|||
0487|074|S|SIDE EFFECTS:  See also Warning section.||
0487|075|S|   Dizziness or difficulty with coordination may occur. If either||
0487|076|S|of these effects lasts or gets worse, tell your doctor or||
0487|077|S|pharmacist promptly. To reduce the risk of dizziness or falling,||
0487|078|S|get up slowly when rising from a sitting or lying position.||
0487|079|S|   This medication may make you sleepy during the day. Tell your||
0487|080|S|doctor if you have daytime drowsiness. Your dose may need to be||
0487|081|S|adjusted.||
0487|082|S|   Remember that this medication has been prescribed because your||
0487|083|S|doctor has judged that the benefit to you is greater than the||
0487|084|S|risk of side effects. Many people using this medication do not||
0487|085|S|have serious side effects.||
0487|086|S|   Tell your doctor right away if you have any serious side||
0487|087|S|effects, including: memory loss, mental/mood/behavior changes||
0487|088|S|(such as new/worsening depression, abnormal thoughts, thoughts of||
0487|089|S|suicide, hallucinations, confusion, agitation, aggressive||
0487|090|S|behavior, anxiety).||
0487|091|S|   Rarely, after taking this drug, people have gotten out of bed||
0487|092|S|and driven vehicles while not fully awake ("sleep-driving").||
0487|093|S|People have also sleepwalked, prepared/eaten food, made phone||
0487|094|S|calls, or had sex while not fully awake. Often, these people do||
0487|095|S|not remember these events. This problem can be dangerous to you||
0487|096|S|or to others. If you find out that you have done any of these||
0487|097|S|activities after taking this medication, tell your doctor right||
0487|098|S|away. Your risk is increased if you use alcohol or other||
0487|099|S|medications that can make you drowsy while taking estazolam.||
0487|100|S|   A very serious allergic reaction to this drug is rare.||
0487|101|S|However, get medical help right away if you notice any symptoms||
0487|102|S|of a serious allergic reaction, including: rash, itching/swelling||
0487|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0487|104|S|breathing.||
0487|105|S|   This is not a complete list of possible side effects. If you||
0487|106|S|notice other effects not listed above, contact your doctor or||
0487|107|S|pharmacist.||
0487|108|S|   In the US -||
0487|109|S|   Call your doctor for medical advice about side effects. You||
0487|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0487|111|S|www.fda.gov/medwatch.||
0487|112|S|   In Canada - Call your doctor for medical advice about side||
0487|113|S|effects. You may report side effects to Health Canada at||
0487|114|S|1-866-234-2345.||
0487|115|B|||
0487|116|P|PRECAUTIONS:  Before taking estazolam, tell your doctor or||
0487|117|P|pharmacist if you are allergic to it; or to other benzodiazepines||
0487|118|P|(such as diazepam, lorazepam); or if you have any other||
0487|119|P|allergies. This product may contain inactive ingredients, which||
0487|120|P|can cause allergic reactions or other problems. Talk to your||
0487|121|P|pharmacist for more details.||
0487|122|P|   Before using this medication, tell your doctor or pharmacist||
0487|123|P|your medical history, especially of: kidney disease, liver||
0487|124|P|disease, lung/breathing problems (such as chronic obstructive||
0487|125|P|pulmonary disease-COPD, sleep apnea), mental/mood problems (such||
0487|126|P|as depression, thoughts of suicide), personal or family history||
0487|127|P|of a substance use disorder (such as overuse of or addiction to||
0487|128|P|drugs/alcohol), personal or family history of sleepwalking, a||
0487|129|P|certain muscle disease (myasthenia gravis).||
0487|130|P|   Since this drug makes you drowsy, do not drive, use machinery,||
0487|131|P|or do anything that needs alertness until you can do it safely.||
0487|132|P|Alcohol or marijuana (cannabis) can make you more drowsy. Avoid||
0487|133|P|alcoholic beverages. Talk to your doctor if you are using||
0487|134|P|marijuana (cannabis).||
0487|135|P|   Before having surgery, tell your doctor or dentist about all||
0487|136|P|the products you use (including prescription drugs,||
0487|137|P|nonprescription drugs, and herbal products).||
0487|138|P|   Older adults may be more sensitive to the side effects of this||
0487|139|P|drug, especially dizziness, confusion, unsteadiness, and||
0487|140|P|excessive drowsiness. These side effects can increase the risk of||
0487|141|P|falling.||
0487|142|P|   Tell your doctor if you are pregnant or plan to become||
0487|143|P|pregnant. You should not become pregnant while using estazolam.||
0487|144|P|Estazolam may harm an unborn baby. Newborn babies of mothers who||
0487|145|P|use this medication late in pregnancy may have symptoms such as||
0487|146|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
0487|147|P|feeding. If you become pregnant, talk to your doctor right away||
0487|148|P|about the risks and benefits of this medication.||
0487|149|P|   This medication may pass into breast milk and have undesirable||
0487|150|P|effects on a nursing infant. Consult your doctor before||
0487|151|P|breastfeeding.||
0487|152|B|||
0487|153|I|DRUG INTERACTIONS:  See also Warning section.||
0487|154|I|   Drug interactions may change how your medications work or||
0487|155|I|increase your risk for serious side effects. This document does||
0487|156|I|not contain all possible drug interactions. Keep a list of all||
0487|157|I|the products you use (including prescription/nonprescription||
0487|158|I|drugs and herbal products) and share it with your doctor and||
0487|159|I|pharmacist. Do not start, stop, or change the dosage of any||
0487|160|I|medicines without your doctor's approval.||
0487|161|I|   A product that may interact with this drug is: sodium oxybate.||
0487|162|I|   Other medications can affect the removal of estazolam from||
0487|163|I|your body, which may affect how estazolam works. Examples include||
0487|164|I|ribociclib, azole antifungals (such as||
0487|165|I|itraconazole/ketoconazole), among others.||
0487|166|I|   The risk of serious side effects (such as slow/shallow||
0487|167|I|breathing, severe drowsiness/dizziness) may be increased if this||
0487|168|I|medication is taken with other products that may also cause||
0487|169|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0487|170|I|if you are taking other products such as opioid pain or cough||
0487|171|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0487|172|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0487|173|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0487|174|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0487|175|I|diphenhydramine).||
0487|176|I|   Check the labels on all your medicines (such as allergy or||
0487|177|I|cough-and-cold products) because they may contain ingredients||
0487|178|I|that cause drowsiness. Ask your pharmacist about using those||
0487|179|I|products safely.||
0487|180|B|||
0487|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0487|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0487|183|O|poison control center right away. US residents can call||
0487|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0487|185|O|Symptoms of overdose may include slowed breathing or a deep sleep||
0487|186|O|from which you cannot be awakened.||
0487|187|B|||
0487|188|N|NOTES:  Do not share this medication with others. Sharing it is||
0487|189|N|against the law.||
0487|190|N|   As you get older, your sleep pattern may naturally change and||
0487|191|N|your sleep may be interrupted several times during the night.||
0487|192|N|Consult your doctor or pharmacist for ways to improve your sleep||
0487|193|N|without medication, such as avoiding caffeine and alcohol close||
0487|194|N|to bedtime, avoiding daytime naps, and going to bed at the same||
0487|195|N|time each night.||
0487|196|B|||
0487|197|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
0487|198|D|time to sleep for 7 to 8 hours afterward. (See also How to Use||
0487|199|D|section.)||
0487|200|B|||
0487|201|R|STORAGE:  Store at room temperature away from light and moisture.||
0487|202|R|Do not store in the bathroom. Keep all medications away from||
0487|203|R|children and pets.||
0487|204|R|   Do not flush medications down the toilet or pour them into a||
0487|205|R|drain unless instructed to do so. Properly discard this product||
0487|206|R|when it is expired or no longer needed. Consult your pharmacist||
0487|207|R|or local waste disposal company.||
0487|208|B|||
0487|209|A|Information last revised May 2024.||
0487|210|A|Copyright(c) 2025 First Databank, Inc.||
0487|211|B|||
0488|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0488|002|Z|does NOT have all possible information about this product. This||
0488|003|Z|information does not assure that this product is safe, effective,||
0488|004|Z|or appropriate for you. This information is not individual||
0488|005|Z|medical advice and does not substitute for the advice of your||
0488|006|Z|health care professional. Always ask your health care||
0488|007|Z|professional for complete information about this product and your||
0488|008|Z|specific health needs.||
0488|009|B|||
0488|010|T|QUAZEPAM - ORAL||
0488|011|F|(KWAY-zeh-pam)||
0488|012|B|||
0488|013|C|COMMON BRAND NAME(S): Doral||
0488|014|B|||
0488|015|W|WARNING:  Quazepam has a risk for abuse and addiction, which can||
0488|016|W|lead to overdose and death. Taking this medication with alcohol||
0488|017|W|or other drugs that can cause drowsiness or breathing problems||
0488|018|W|(especially opioid medications such as codeine, hydrocodone) may||
0488|019|W|cause very serious side effects, including death. To lower your||
0488|020|W|risk, your doctor should have you take the smallest dose of||
0488|021|W|quazepam that works, and take it for the shortest possible time.||
0488|022|W|Be sure you know how to take quazepam and what other drugs you||
0488|023|W|should avoid taking with it. See also Drug Interactions section.||
0488|024|W|Get medical help right away if any of these very serious side||
0488|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
0488|026|W|severe drowsiness/dizziness, difficulty waking up.||
0488|027|W|   Suddenly stopping this medication may cause serious (possibly||
0488|028|W|fatal) withdrawal, especially if you have used it for a long time||
0488|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
0488|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
0488|031|W|you have any withdrawal symptoms such as headaches, restlessness,||
0488|032|W|hallucinations/confusion, depression, nausea, or seizures.||
0488|033|W|Withdrawal symptoms may sometimes last weeks to months.||
0488|034|B|||
0488|035|U|USES:  This medication is used for the short-term treatment of||
0488|036|U|patients with trouble sleeping (insomnia). It is generally used||
0488|037|U|for 7-10 days. It may help you fall asleep faster and decrease||
0488|038|U|the number of times you awaken during the night. It may also help||
0488|039|U|you sleep for a longer period of time. Quazepam belongs to a||
0488|040|U|class of medications called benzodiazepines. It acts on your||
0488|041|U|brain to produce a calming effect.||
0488|042|B|||
0488|043|H|HOW TO USE:  See also Warning section.||
0488|044|H|   Read the Medication Guide provided by your pharmacist before||
0488|045|H|you start using quazepam and each time you get a refill. If you||
0488|046|H|have any questions, ask your doctor or pharmacist.||
0488|047|H|   Take this medication by mouth with or without food as directed||
0488|048|H|by your doctor, usually once nightly, 30 minutes before bedtime.||
0488|049|H|The dosage is based on your medical condition, age, and response||
0488|050|H|to treatment.||
0488|051|H|   Although unlikely, this drug can rarely cause temporary memory||
0488|052|H|loss. To avoid this effect, do not take a dose of this drug||
0488|053|H|unless you have time for a full night's sleep that lasts at least||
0488|054|H|7-8 hours. For example, do not take this drug during an overnight||
0488|055|H|plane flight of less than 8 hours.||
0488|056|H|   Though it helps many people, this medication may sometimes||
0488|057|H|cause addiction. This risk may be higher if you have a substance||
0488|058|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0488|059|H|Do not increase your dose, take it more often, or use it for a||
0488|060|H|longer time than prescribed. Properly stop the medication when so||
0488|061|H|directed.||
0488|062|H|   When used for an extended period, this medication may not work||
0488|063|H|as well and may require different dosing. Talk with your doctor||
0488|064|H|if this medication stops working well.||
0488|065|H|   You may experience trouble sleeping the first few nights after||
0488|066|H|you stop taking this medication. This is called rebound insomnia||
0488|067|H|and it is normal. It will usually go away after 1-2 nights. If||
0488|068|H|this effect continues, contact your doctor.||
0488|069|H|   Tell your doctor if your condition lasts or gets worse after 7||
0488|070|H|to 10 days.||
0488|071|B|||
0488|072|S|SIDE EFFECTS:  See also Warning section.||
0488|073|S|   Dizziness, loss of coordination, or blurred vision may occur.||
0488|074|S|To minimize falls, remember to get up slowly when rising from a||
0488|075|S|seated or lying position. If any of these effects last or get||
0488|076|S|worse, notify your doctor or pharmacist promptly.||
0488|077|S|   This medication may make you sleepy during the day. Tell your||
0488|078|S|doctor if you have daytime drowsiness. Your dose may need to be||
0488|079|S|adjusted.||
0488|080|S|   Remember that this medication has been prescribed because your||
0488|081|S|doctor has judged that the benefit to you is greater than the||
0488|082|S|risk of side effects. Many people using this medication do not||
0488|083|S|have serious side effects.||
0488|084|S|   Tell your doctor right away if you have any serious side||
0488|085|S|effects, including: uncontrolled movements (tremor), sweating,||
0488|086|S|unusual feelings of well-being (euphoria), memory loss,||
0488|087|S|mental/mood changes (such as hallucinations, agitation,||
0488|088|S|restlessness, confusion, depression, rare thoughts of suicide),||
0488|089|S|increased or vivid dreams, vision changes, fainting, signs of||
0488|090|S|infection (such as sore throat that doesn't go away, fever,||
0488|091|S|chills), unusual paleness, unusual tiredness,||
0488|092|S|fast/pounding/irregular heartbeat, yellowing eyes/skin, dark||
0488|093|S|urine.||
0488|094|S|   Some people who take sleep medications have reported getting||
0488|095|S|out of bed and sleepwalking, driving, eating, talking on the||
0488|096|S|phone, or having sex while not fully awake. Often they do not||
0488|097|S|remember these activities. This problem can be dangerous to you||
0488|098|S|or to others. If you find out that you have done any of these||
0488|099|S|activities after taking this medication, tell your doctor right||
0488|100|S|away. Your risk is increased if you use alcohol or other||
0488|101|S|medications that can make you drowsy while taking quazepam.||
0488|102|S|   A very serious allergic reaction to this drug is rare.||
0488|103|S|However, get medical help right away if you notice any symptoms||
0488|104|S|of a serious allergic reaction, including: rash, itching/swelling||
0488|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0488|106|S|breathing.||
0488|107|S|   This is not a complete list of possible side effects. If you||
0488|108|S|notice other effects not listed above, contact your doctor or||
0488|109|S|pharmacist.||
0488|110|S|   In the US -||
0488|111|S|   Call your doctor for medical advice about side effects. You||
0488|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0488|113|S|www.fda.gov/medwatch.||
0488|114|S|   In Canada - Call your doctor for medical advice about side||
0488|115|S|effects. You may report side effects to Health Canada at||
0488|116|S|1-866-234-2345.||
0488|117|B|||
0488|118|P|PRECAUTIONS:  Before taking quazepam, tell your doctor or||
0488|119|P|pharmacist if you are allergic to it; or to other benzodiazepines||
0488|120|P|(such as lorazepam, diazepam); or if you have any other||
0488|121|P|allergies. This product may contain inactive ingredients, which||
0488|122|P|can cause allergic reactions or other problems. Talk to your||
0488|123|P|pharmacist for more details.||
0488|124|P|   Before using this medication, tell your doctor or pharmacist||
0488|125|P|your medical history, especially of: liver disease, kidney||
0488|126|P|disease, mental/mood problems (such as depression, panic||
0488|127|P|disorder), lung problems (such as pulmonary insufficiency, sleep||
0488|128|P|apnea), seizures, personal or family history of a substance use||
0488|129|P|disorder (such as overuse of or addiction to drugs/alcohol).||
0488|130|P|   This drug may make you dizzy or drowsy or temporarily blur||
0488|131|P|your vision. Alcohol or marijuana (cannabis) can make you more||
0488|132|P|dizzy or drowsy. Do not drive, use machinery, or do anything that||
0488|133|P|needs alertness or clear vision until you can do it safely. Avoid||
0488|134|P|alcoholic beverages. Talk to your doctor if you are using||
0488|135|P|marijuana (cannabis).||
0488|136|P|   Before having surgery, tell your doctor or dentist about all||
0488|137|P|the products you use (including prescription drugs,||
0488|138|P|nonprescription drugs, and herbal products).||
0488|139|P|   Older adults may be more sensitive to the side effects of this||
0488|140|P|drug, especially drowsiness, dizziness, loss of coordination, and||
0488|141|P|confusion. These side effects can increase the risk of falling.||
0488|142|P|   Tell your doctor if you are pregnant or plan to become||
0488|143|P|pregnant. You should not become pregnant while using quazepam.||
0488|144|P|Quazepam may harm an unborn baby. Newborn babies of mothers who||
0488|145|P|use this medication late in pregnancy may have symptoms such as||
0488|146|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
0488|147|P|feeding. If you become pregnant, talk to your doctor right away||
0488|148|P|about the risks and benefits of this medication.||
0488|149|P|   This medication passes into breast milk and may have||
0488|150|P|undesirable effects on a nursing infant. Consult your doctor||
0488|151|P|before breastfeeding.||
0488|152|B|||
0488|153|I|DRUG INTERACTIONS:  See also Warning section.||
0488|154|I|   Drug interactions may change how your medications work or||
0488|155|I|increase your risk for serious side effects. This document does||
0488|156|I|not contain all possible drug interactions. Keep a list of all||
0488|157|I|the products you use (including prescription/nonprescription||
0488|158|I|drugs and herbal products) and share it with your doctor and||
0488|159|I|pharmacist. Do not start, stop, or change the dosage of any||
0488|160|I|medicines without your doctor's approval.||
0488|161|I|   Some products that may interact with this drug are:||
0488|162|I|cimetidine, clozapine, disulfiram, certain SSRI antidepressants||
0488|163|I|(fluoxetine, fluvoxamine), kava, nefazodone, sodium oxybate.||
0488|164|I|   The risk of serious side effects (such as slow/shallow||
0488|165|I|breathing, severe drowsiness/dizziness) may be increased if this||
0488|166|I|medication is taken with other products that may also cause||
0488|167|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0488|168|I|if you are taking other products such as opioid pain or cough||
0488|169|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0488|170|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0488|171|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0488|172|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0488|173|I|diphenhydramine).||
0488|174|I|   Check the labels on all your medicines (such as allergy or||
0488|175|I|cough-and-cold products) because they may contain ingredients||
0488|176|I|that cause drowsiness. Ask your pharmacist about using those||
0488|177|I|products safely.||
0488|178|B|||
0488|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0488|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0488|181|O|poison control center right away. US residents can call||
0488|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0488|183|O|Symptoms of overdose may include: slow breathing, trouble||
0488|184|O|speaking, or a deep sleep from which you cannot be awakened.||
0488|185|B|||
0488|186|N|NOTES:  Do not share this medication with others. Sharing it is||
0488|187|N|against the law.||
0488|188|N|   This medication has been prescribed for your current condition||
0488|189|N|only. Do not use it later for another condition unless told to do||
0488|190|N|so by your doctor. A different medication may be necessary in||
0488|191|N|those cases.||
0488|192|N|   If you are using this drug for a long time, lab and/or medical||
0488|193|N|tests (such as liver/kidney function, blood count) may be done||
0488|194|N|while you are taking this medication. Keep all medical and lab||
0488|195|N|appointments. Consult your doctor for more details.||
0488|196|N|   If you require treatment for more than 7-10 days, lab and/or||
0488|197|N|medical tests should be done to find the cause of your sleep||
0488|198|N|problem. Consult with your doctor for more details.||
0488|199|N|   As you get older, your sleep pattern may naturally change and||
0488|200|N|your sleep may be interrupted several times during the night.||
0488|201|N|Consult your doctor or pharmacist for ways to improve your sleep||
0488|202|N|without medication, such as avoiding caffeine and alcohol close||
0488|203|N|to bedtime, avoiding daytime naps, and avoiding going to bed too||
0488|204|N|early each night.||
0488|205|B|||
0488|206|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
0488|207|D|if it is still near bedtime. If you don't remember until the next||
0488|208|D|day, skip the missed dose. Take your next dose that night at||
0488|209|D|bedtime. Do not double the dose to catch up.||
0488|210|B|||
0488|211|R|STORAGE:  Store at room temperature away from light and moisture.||
0488|212|R|Do not store in the bathroom. Keep all medications away from||
0488|213|R|children and pets.||
0488|214|R|   Do not flush medications down the toilet or pour them into a||
0488|215|R|drain unless instructed to do so. Properly discard this product||
0488|216|R|when it is expired or no longer needed. Consult your pharmacist||
0488|217|R|or local waste disposal company.||
0488|218|B|||
0488|219|A|Information last revised April 2025.||
0488|220|A|Copyright(c) 2025 First Databank, Inc.||
0488|221|B|||
0489|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0489|002|Z|does NOT have all possible information about this product. This||
0489|003|Z|information does not assure that this product is safe, effective,||
0489|004|Z|or appropriate for you. This information is not individual||
0489|005|Z|medical advice and does not substitute for the advice of your||
0489|006|Z|health care professional. Always ask your health care||
0489|007|Z|professional for complete information about this product and your||
0489|008|Z|specific health needs.||
0489|009|B|||
0489|010|T|FOLLITROPIN ALFA MULTIDOSE VIAL - INJECTION||
0489|011|F|(FOL-i-TROE-pin AL-fa)||
0489|012|B|||
0489|013|C|COMMON BRAND NAME(S): Gonal-F||
0489|014|B|||
0489|015|U|USES:  This medication contains follicle-stimulating hormone||
0489|016|U|(FSH) and is used to treat certain fertility problems in women||
0489|017|U|and men. In women, follitropin alfa helps stimulate healthy||
0489|018|U|ovaries to produce eggs. This medication is usually used in||
0489|019|U|combination with another hormone (hCG) to bring about the growth||
0489|020|U|and release of a mature egg (ovulation). In men, this medication||
0489|021|U|helps stimulate healthy testes to produce sperm. It is also used||
0489|022|U|in combination with hCG.||
0489|023|U|   This medication is not recommended for women whose ovaries no||
0489|024|U|longer make eggs properly (primary ovarian failure) or for men||
0489|025|U|whose testes no longer make sperm properly (primary testicular||
0489|026|U|failure).||
0489|027|B|||
0489|028|H|HOW TO USE:  Read the Patient Information Leaflet and||
0489|029|H|Instructions for Use if available from your pharmacist before you||
0489|030|H|start using follitropin alfa and each time you get a refill. Ask||
0489|031|H|your health care professional how to prepare and use this||
0489|032|H|medication. If you have any questions, ask your doctor or||
0489|033|H|pharmacist.||
0489|034|H|   Inject this medication under the skin or into a muscle as||
0489|035|H|directed by your doctor. The injection is given in the upper||
0489|036|H|arms, thighs, or abdomen. The dosage is based on your medical||
0489|037|H|condition, response to treatment, and labs.||
0489|038|H|   If the medication is stored in the refrigerator, allow the||
0489|039|H|medication to reach room temperature before use. Do not shake the||
0489|040|H|vial. Before using, check this product for particles or||
0489|041|H|discoloration. If either is present, do not use the liquid.||
0489|042|H|Before injecting each dose, clean the skin you are going to||
0489|043|H|inject into (the injection site) with rubbing alcohol. Change the||
0489|044|H|injection site each time to lessen injury under the skin. To||
0489|045|H|lessen bruising, do not rub the injection site after a shot.||
0489|046|H|Learn how to store and discard medical supplies safely.||
0489|047|H|   Use this medication exactly as directed by your doctor to get||
0489|048|H|the most benefit from it. Do not increase your dose or use this||
0489|049|H|drug more often or for longer than prescribed.||
0489|050|B|||
0489|051|S|SIDE EFFECTS:  Headache, mild stomach/abdominal pain, diarrhea,||
0489|052|S|bloating, redness/pain at the injection site, acne, or breast||
0489|053|S|tenderness/pain may occur. If any of these effects last or get||
0489|054|S|worse, tell your doctor or pharmacist promptly.||
0489|055|S|   Remember that this medication has been prescribed because your||
0489|056|S|doctor has judged that the benefit to you is greater than the||
0489|057|S|risk of side effects. Many people using this medication do not||
0489|058|S|have serious side effects.||
0489|059|S|   Tell your doctor right away if you have any serious side||
0489|060|S|effects, including: bleeding from the vagina/uterus, flu-like||
0489|061|S|symptoms (such as fever, chills, muscle ache, tiredness),||
0489|062|S|swelling of ankles/hands/feet.||
0489|063|S|   Get medical help right away if you have any very serious side||
0489|064|S|effects, including: shortness of breath/rapid breathing,||
0489|065|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
0489|066|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0489|067|S|sudden severe headache, trouble speaking, weakness on one side of||
0489|068|S|the body, sudden vision changes.||
0489|069|S|   This medication may cause a condition known as ovarian||
0489|070|S|hyperstimulation syndrome (OHSS). This condition may occur during||
0489|071|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
0489|072|S|build up in the stomach, chest, and heart area. Get medical help||
0489|073|S|right away if you develop the following side effects: severe pain||
0489|074|S|or swelling in the lower abdominal (pelvic) area, severe||
0489|075|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
0489|076|S|urination.||
0489|077|S|   A very serious allergic reaction to this drug is rare.||
0489|078|S|However, get medical help right away if you notice any symptoms||
0489|079|S|of a serious allergic reaction, including: rash, itching/swelling||
0489|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0489|081|S|breathing.||
0489|082|S|   This is not a complete list of possible side effects. If you||
0489|083|S|notice other effects not listed above, contact your doctor or||
0489|084|S|pharmacist.||
0489|085|S|   In the US -||
0489|086|S|   Call your doctor for medical advice about side effects. You||
0489|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0489|088|S|www.fda.gov/medwatch.||
0489|089|S|   In Canada - Call your doctor for medical advice about side||
0489|090|S|effects. You may report side effects to Health Canada at||
0489|091|S|1-866-234-2345.||
0489|092|B|||
0489|093|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0489|094|P|pharmacist if you are allergic to it; or to other products||
0489|095|P|containing follicle-stimulating hormone (FSH); or if you have any||
0489|096|P|other allergies. This product may contain inactive ingredients,||
0489|097|P|which can cause allergic reactions or other problems. Talk to||
0489|098|P|your pharmacist for more details.||
0489|099|P|   Before using this medication, tell your doctor or pharmacist||
0489|100|P|your medical history, especially of: other fertility problems||
0489|101|P|(such as primary ovarian failure or testicular failure), abnormal||
0489|102|P|bleeding from the vagina/uterus, thyroid problems, adrenal gland||
0489|103|P|problems, cancer of the reproductive organs (such as breast,||
0489|104|P|uterus, ovary, testis), tumor in the brain (such as pituitary||
0489|105|P|tumor), ovarian cysts or enlarged ovaries, blood clots, stroke,||
0489|106|P|certain heart diseases (such as angina, heart attack), lung||
0489|107|P|problems (such as asthma).||
0489|108|P|   Before having surgery, tell your doctor or dentist about all||
0489|109|P|the products you use (including prescription drugs,||
0489|110|P|nonprescription drugs, and herbal products).||
0489|111|P|   Multiple births may occur as a result of this treatment.||
0489|112|P|Consult your doctor for more details.||
0489|113|P|   Stop using this medication when you become pregnant. This||
0489|114|P|medication must not be used during pregnancy. If you think you||
0489|115|P|may be pregnant, tell your doctor right away.||
0489|116|P|   It is unknown if this drug passes into breast milk. Consult||
0489|117|P|your doctor before breastfeeding.||
0489|118|B|||
0489|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0489|120|I|medications work or increase your risk for serious side effects.||
0489|121|I|This document does not contain all possible drug interactions.||
0489|122|I|Keep a list of all the products you use (including||
0489|123|I|prescription/nonprescription drugs and herbal products) and share||
0489|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
0489|125|I|the dosage of any medicines without your doctor's approval.||
0489|126|I|   A product that may interact with this drug is: gonadorelin.||
0489|127|B|||
0489|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0489|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0489|130|O|poison control center right away. US residents can call||
0489|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0489|132|B|||
0489|133|N|NOTES:  Do not share this medication with others.||
0489|134|N|   Lab and/or medical tests (such as vaginal ultrasound, hormone||
0489|135|N|levels, liver tests) may be done while you are using this||
0489|136|N|medication. Keep all medical and lab appointments. Consult your||
0489|137|N|doctor for more details.||
0489|138|B|||
0489|139|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
0489|140|D|right away for a new dosing schedule. Do not double the dose to||
0489|141|D|catch up.||
0489|142|B|||
0489|143|R|STORAGE:  Store in the refrigerator or at room temperature away||
0489|144|R|from light. Do not freeze. Once vial is mixed, discard any unused||
0489|145|R|portion after 28 days. Keep all medications away from children||
0489|146|R|and pets.||
0489|147|R|   Do not flush medications down the toilet or pour them into a||
0489|148|R|drain unless instructed to do so. Properly discard this product||
0489|149|R|when it is expired or no longer needed. Consult your pharmacist||
0489|150|R|or local waste disposal company.||
0489|151|B|||
0489|152|A|Information last revised September 2024.||
0489|153|A|Copyright(c) 2025 First Databank, Inc.||
0489|154|B|||
0490|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0490|002|Z|does NOT have all possible information about this product. This||
0490|003|Z|information does not assure that this product is safe, effective,||
0490|004|Z|or appropriate for you. This information is not individual||
0490|005|Z|medical advice and does not substitute for the advice of your||
0490|006|Z|health care professional. Always ask your health care||
0490|007|Z|professional for complete information about this product and your||
0490|008|Z|specific health needs.||
0490|009|B|||
0490|010|T|DONEPEZIL DISINTEGRATING TABLET - ORAL||
0490|011|F|(doh-NEP-eh-zil)||
0490|012|B|||
0490|013|C|COMMON BRAND NAME(S): Aricept ODT||
0490|014|B|||
0490|015|U|USES:  Donepezil is used to treat confusion (dementia) related to||
0490|016|U|Alzheimer's disease. It does not cure Alzheimer's disease, but it||
0490|017|U|may improve memory, awareness, and the ability to function. This||
0490|018|U|medication is an enzyme blocker that works by restoring the||
0490|019|U|balance of natural substances (neurotransmitters) in the brain.||
0490|020|B|||
0490|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0490|022|H|from your pharmacist before you start taking donepezil and each||
0490|023|H|time you get a refill. If you have any questions, ask your doctor||
0490|024|H|or pharmacist.||
0490|025|H|   Do not remove the tablet from its pouch until you are ready to||
0490|026|H|take it. Dry your hands before handling the medication. Open the||
0490|027|H|pouch and peel back the foil layer. Do not push the tablet||
0490|028|H|through the foil because it may get damaged. Place the dose on||
0490|029|H|your tongue where it will quickly dissolve. After the tablet||
0490|030|H|dissolves completely, drink a glass of water.||
0490|031|H|   Take this medication with or without food as directed by your||
0490|032|H|doctor, usually just before bedtime. If you experience sleep||
0490|033|H|problems (insomnia), talk to your doctor about switching to a||
0490|034|H|morning dose.||
0490|035|H|   Dosage is based on your medical condition and response to||
0490|036|H|treatment. To reduce your risk of side effects (such as nausea||
0490|037|H|and diarrhea), your doctor will start this medication at a low||
0490|038|H|dose and gradually increase your dose over weeks to months.||
0490|039|H|Follow your doctor's instructions carefully. Do not increase your||
0490|040|H|dose or use this drug more often than prescribed.||
0490|041|H|   If you do not take donepezil for 7 or more days in a row, talk||
0490|042|H|with your doctor before starting again. You may need to start at||
0490|043|H|a lower dose.||
0490|044|H|   Use this medication regularly in order to get the most benefit||
0490|045|H|from it. To help you remember, take it at the same time each day.||
0490|046|H|Do not stop taking it unless your doctor instructs you to do so.||
0490|047|H|It may take several weeks before you get the full benefit of this||
0490|048|H|drug.||
0490|049|H|   Tell your doctor if your condition gets worse.||
0490|050|B|||
0490|051|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, loss of||
0490|052|S|appetite/weight loss, dizziness, drowsiness, weakness, trouble||
0490|053|S|sleeping, shakiness (tremor), or muscle cramps may occur as your||
0490|054|S|body adjusts to the drug. These effects usually last 1-3 weeks||
0490|055|S|and then lessen. If any of these effects last or get worse,||
0490|056|S|notify your doctor or pharmacist promptly.||
0490|057|S|   Remember that this medication has been prescribed because your||
0490|058|S|doctor has judged that the benefit to you is greater than the||
0490|059|S|risk of side effects. Many people using this medication do not||
0490|060|S|have serious side effects.||
0490|061|S|   Tell your doctor right away if you have any serious side||
0490|062|S|effects, including: trouble urinating, severe stomach/abdominal||
0490|063|S|pain, black stools, vomit that looks like coffee grounds,||
0490|064|S|seizures.||
0490|065|S|   Get medical help right away if you have any very serious side||
0490|066|S|effects, including: slow/fast/irregular heartbeat, severe||
0490|067|S|dizziness, fainting.||
0490|068|S|   A very serious allergic reaction to this drug is rare.||
0490|069|S|However, get medical help right away if you notice any symptoms||
0490|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0490|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0490|072|S|breathing.||
0490|073|S|   This is not a complete list of possible side effects. If you||
0490|074|S|notice other effects not listed above, contact your doctor or||
0490|075|S|pharmacist.||
0490|076|S|   In the US -||
0490|077|S|   Call your doctor for medical advice about side effects. You||
0490|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0490|079|S|www.fda.gov/medwatch.||
0490|080|S|   In Canada - Call your doctor for medical advice about side||
0490|081|S|effects. You may report side effects to Health Canada at||
0490|082|S|1-866-234-2345.||
0490|083|B|||
0490|084|P|PRECAUTIONS:  Before taking donepezil, tell your doctor or||
0490|085|P|pharmacist if you are allergic to it; or if you have any other||
0490|086|P|allergies. This product may contain inactive ingredients, which||
0490|087|P|can cause allergic reactions or other problems. Talk to your||
0490|088|P|pharmacist for more details.||
0490|089|P|   Before using this medication, tell your doctor or pharmacist||
0490|090|P|your medical history, especially of: breathing problems (such as||
0490|091|P|asthma, chronic obstructive pulmonary disease), fainting,||
0490|092|P|seizures, stomach/intestinal disease (such as ulcers, bleeding),||
0490|093|P|trouble urinating (such as enlarged prostate).||
0490|094|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0490|095|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0490|096|P|machinery, or do anything that needs alertness until you can do||
0490|097|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0490|098|P|are using marijuana (cannabis).||
0490|099|P|   Donepezil may cause a condition that affects the heart rhythm||
0490|100|P|(QT prolongation). QT prolongation can rarely cause serious||
0490|101|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0490|102|P|as severe dizziness, fainting) that need medical attention right||
0490|103|P|away.||
0490|104|P|   The risk of QT prolongation may be increased if you have||
0490|105|P|certain medical conditions or are taking other drugs that may||
0490|106|P|cause QT prolongation. Before using donepezil, tell your doctor||
0490|107|P|or pharmacist of all the drugs you take and if you have any of||
0490|108|P|the following conditions: certain heart problems (heart failure,||
0490|109|P|slow heartbeat, QT prolongation in the EKG), family history of||
0490|110|P|certain heart problems (QT prolongation in the EKG, sudden||
0490|111|P|cardiac death).||
0490|112|P|   Low levels of potassium or magnesium in the blood may also||
0490|113|P|increase your risk of QT prolongation. This risk may increase if||
0490|114|P|you use certain drugs (such as diuretics/"water pills") or if you||
0490|115|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0490|116|P|Talk to your doctor about using donepezil safely.||
0490|117|P|   Before having surgery, tell your doctor or dentist about all||
0490|118|P|the products you use (including prescription drugs,||
0490|119|P|nonprescription drugs, and herbal products).||
0490|120|P|   Older adults may be more sensitive to the side effects of this||
0490|121|P|drug, especially QT prolongation (see above).||
0490|122|P|   During pregnancy, this medication should be used only when||
0490|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
0490|124|P|   It is unknown if this drug passes into breast milk. Consult||
0490|125|P|your doctor before breastfeeding.||
0490|126|B|||
0490|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0490|128|I|medications work or increase your risk for serious side effects.||
0490|129|I|This document does not contain all possible drug interactions.||
0490|130|I|Keep a list of all the products you use (including||
0490|131|I|prescription/nonprescription drugs and herbal products) and share||
0490|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
0490|133|I|the dosage of any medicines without your doctor's approval.||
0490|134|I|   Some products that may interact with this drug include:||
0490|135|I|aspirin/non-steroidal anti-inflammatory drugs (NSAIDs, such as||
0490|136|I|ibuprofen, naproxen).||
0490|137|I|   Check all prescription and nonprescription medicine labels||
0490|138|I|carefully since many medications contain pain relievers/fever||
0490|139|I|reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that if||
0490|140|I|taken together with donepezil may increase your risk for||
0490|141|I|stomach/intestinal bleeding. However, if your doctor has told you||
0490|142|I|to take low-dose aspirin to prevent heart attack or stroke||
0490|143|I|(usually 81-162 milligrams a day), you should keep taking the||
0490|144|I|aspirin unless your doctor tells you not to. Ask your doctor or||
0490|145|I|pharmacist for more details.||
0490|146|B|||
0490|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0490|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0490|149|O|poison control center right away. US residents can call||
0490|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0490|151|O|Symptoms of overdose may include nausea/vomiting that is severe||
0490|152|O|or doesn't stop, excessive sweating, very slow heartbeat, slow or||
0490|153|O|shallow breathing, seizures.||
0490|154|B|||
0490|155|N|NOTES:  Do not share this medication with others.||
0490|156|N|   Lab and/or medical tests (such as weight) should be done while||
0490|157|N|you are taking this medication. Keep all medical and lab||
0490|158|N|appointments. Consult your doctor for more details.||
0490|159|B|||
0490|160|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
0490|161|D|next dose at the regular time. Do not double the dose to catch||
0490|162|D|up.||
0490|163|B|||
0490|164|R|STORAGE:  Store at room temperature away from light and moisture.||
0490|165|R|Do not store in the bathroom. Keep all medications away from||
0490|166|R|children and pets.||
0490|167|R|   Do not flush medications down the toilet or pour them into a||
0490|168|R|drain unless instructed to do so. Properly discard this product||
0490|169|R|when it is expired or no longer needed. Consult your pharmacist||
0490|170|R|or local waste disposal company.||
0490|171|B|||
0490|172|A|Information last revised February 2025.||
0490|173|A|Copyright(c) 2025 First Databank, Inc.||
0490|174|B|||
0491|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0491|002|Z|does NOT have all possible information about this product. This||
0491|003|Z|information does not assure that this product is safe, effective,||
0491|004|Z|or appropriate for you. This information is not individual||
0491|005|Z|medical advice and does not substitute for the advice of your||
0491|006|Z|health care professional. Always ask your health care||
0491|007|Z|professional for complete information about this product and your||
0491|008|Z|specific health needs.||
0491|009|B|||
0491|010|T|ESZOPICLONE - ORAL||
0491|011|F|(es-zoe-PIK-lone)||
0491|012|B|||
0491|013|C|COMMON BRAND NAME(S): Lunesta||
0491|014|B|||
0491|015|W|WARNING:  Rarely, after taking this drug, people have gotten out||
0491|016|W|of bed and driven vehicles while not fully awake||
0491|017|W|("sleep-driving"). People have also sleepwalked, prepared/eaten||
0491|018|W|food, made phone calls, or had sex while not fully awake. Often,||
0491|019|W|these people do not remember these events. This problem can be||
0491|020|W|dangerous (possibly fatal) to you or to others. If you find out||
0491|021|W|that you have done any of these activities after taking this||
0491|022|W|medication, tell your doctor right away. You should not take this||
0491|023|W|medication or similar medications (such as zaleplon, zolpidem) if||
0491|024|W|you have this reaction to the medication.||
0491|025|B|||
0491|026|U|USES:  This medication is used to treat a certain sleep problem||
0491|027|U|(insomnia). It may help you fall asleep faster, stay asleep||
0491|028|U|longer, and lessen how often you wake up during the night, so you||
0491|029|U|can get a better night's rest. Eszopiclone belongs to a class of||
0491|030|U|drugs called sedative-hypnotics. It acts on your brain to produce||
0491|031|U|a calming effect.||
0491|032|U|   Use of this medication is usually limited to short treatment||
0491|033|U|periods of 1 to 2 weeks or less. If your insomnia continues for a||
0491|034|U|longer time, talk to your doctor to see if you need other||
0491|035|U|treatment.||
0491|036|B|||
0491|037|H|HOW TO USE:  Read the Medication Guide provided by your||
0491|038|H|pharmacist before you start using eszopiclone and each time you||
0491|039|H|get a refill. If you have any questions, ask your doctor or||
0491|040|H|pharmacist.||
0491|041|H|   Take this medication by mouth as directed by your doctor,||
0491|042|H|usually once nightly just before you get into bed. Do not take it||
0491|043|H|with or right after a high-fat or heavy meal since it may not||
0491|044|H|work as well. The dosage is based on your medical condition, age,||
0491|045|H|response to treatment, and other medications you may be taking.||
0491|046|H|Be sure to tell your doctor and pharmacist about all the products||
0491|047|H|you use (including prescription drugs, nonprescription drugs, and||
0491|048|H|herbal products).||
0491|049|H|    To reduce your risk of side effects, your doctor will direct||
0491|050|H|you to start this medication at a low dose and gradually increase||
0491|051|H|your dose if needed. Follow your doctor's instructions carefully.||
0491|052|H|Do not take more of this medication than prescribed because your||
0491|053|H|risk of side effects will increase.||
0491|054|H|   Do not take a dose of this drug unless you have time for a||
0491|055|H|full night's sleep of at least 7 to 8 hours. If you have to wake||
0491|056|H|up before that, you may have some memory loss and may have||
0491|057|H|trouble safely doing anything that needs alertness, such as||
0491|058|H|driving or operating machinery. (See also Precautions section.)||
0491|059|H|   If you suddenly stop using this medication, you may have||
0491|060|H|withdrawal symptoms (such as nausea, vomiting, flushing, stomach||
0491|061|H|cramps, nervousness, shakiness). To help prevent withdrawal, your||
0491|062|H|doctor may lower your dose slowly. Withdrawal is more likely if||
0491|063|H|you have used eszopiclone for a long time or in high doses. Tell||
0491|064|H|your doctor or pharmacist right away if you have withdrawal.||
0491|065|H|   When this medication is used for a long time, it may not work||
0491|066|H|as well. Talk with your doctor if this medication stops working||
0491|067|H|well.||
0491|068|H|   Though it helps many people, this medication may sometimes||
0491|069|H|cause addiction. This risk may be higher if you have a substance||
0491|070|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0491|071|H|Take this medication exactly as prescribed to lower the risk of||
0491|072|H|addiction. Ask your doctor or pharmacist for more details.||
0491|073|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
0491|074|H|or if it gets worse.||
0491|075|H|   You may have trouble sleeping the first few nights after you||
0491|076|H|stop taking this medication. This is called rebound insomnia and||
0491|077|H|is normal. It will usually go away after 1 or 2 nights. If this||
0491|078|H|effect continues, contact your doctor.||
0491|079|B|||
0491|080|S|SIDE EFFECTS:  See also Warning section.||
0491|081|S|   Dizziness, dry mouth, unpleasant taste, or difficulty with||
0491|082|S|coordination may occur. If any of these effects last or get||
0491|083|S|worse, tell your doctor or pharmacist promptly. To reduce the||
0491|084|S|risk of dizziness or falling, get up slowly when rising from a||
0491|085|S|sitting or lying position.||
0491|086|S|   This medication may make you sleepy during the day. Tell your||
0491|087|S|doctor if you have daytime drowsiness. Your dose may need to be||
0491|088|S|adjusted.||
0491|089|S|   Remember that this medication has been prescribed because your||
0491|090|S|doctor has judged that the benefit to you is greater than the||
0491|091|S|risk of side effects. Many people using this medication do not||
0491|092|S|have serious side effects.||
0491|093|S|   Tell your doctor right away if you have any serious side||
0491|094|S|effects, including: memory loss, mental/mood/behavior changes||
0491|095|S|(such as new/worsening depression, abnormal thoughts, thoughts of||
0491|096|S|suicide, hallucinations, confusion, agitation, aggressive||
0491|097|S|behavior, anxiety).||
0491|098|S|   A very serious allergic reaction to this drug is rare.||
0491|099|S|However, get medical help right away if you notice any symptoms||
0491|100|S|of a serious allergic reaction, including: rash, itching/swelling||
0491|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0491|102|S|breathing.||
0491|103|S|   This is not a complete list of possible side effects. If you||
0491|104|S|notice other effects not listed above, contact your doctor or||
0491|105|S|pharmacist.||
0491|106|S|   In the US -||
0491|107|S|   Call your doctor for medical advice about side effects. You||
0491|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0491|109|S|www.fda.gov/medwatch.||
0491|110|S|   In Canada - Call your doctor for medical advice about side||
0491|111|S|effects. You may report side effects to Health Canada at||
0491|112|S|1-866-234-2345.||
0491|113|B|||
0491|114|P|PRECAUTIONS:  See also Warning section.||
0491|115|P|   Before taking eszopiclone, tell your doctor or pharmacist if||
0491|116|P|you are allergic to it; or to zopiclone; or if you have any other||
0491|117|P|allergies. This product may contain inactive ingredients, which||
0491|118|P|can cause allergic reactions or other problems. Talk to your||
0491|119|P|pharmacist for more details.||
0491|120|P|   Before using this medication, tell your doctor or pharmacist||
0491|121|P|your medical history, especially of: kidney disease, liver||
0491|122|P|disease, lung/breathing problems (such as chronic obstructive||
0491|123|P|pulmonary disease-COPD, sleep apnea), mental/mood problems (such||
0491|124|P|as depression, thoughts of suicide), personal or family history||
0491|125|P|of a substance use disorder (such as overuse of or addiction to||
0491|126|P|drugs/alcohol), personal or family history of sleepwalking, a||
0491|127|P|certain muscle disease (myasthenia gravis).||
0491|128|P|   The effects of this drug can last even after you wake up the||
0491|129|P|next day. If you did not get 7 to 8 hours of sleep or took other||
0491|130|P|medications that made you sleepy or are more sensitive to this||
0491|131|P|drug, you may feel alert but not think clearly enough to drive.||
0491|132|P|Alcohol or marijuana (cannabis) can also make you more sleepy.||
0491|133|P|Wait at least 8 hours after taking this drug before driving, and||
0491|134|P|do not drive, use machinery, or do anything that needs alertness||
0491|135|P|until you can do it safely. Avoid alcoholic beverages. Talk to||
0491|136|P|your doctor if you are using marijuana (cannabis). If you take||
0491|137|P|the 3 milligram dosage of eszopiclone, do not drive, use||
0491|138|P|machinery, or do anything that needs alertness the next day.||
0491|139|P|   Before having surgery, tell your doctor or dentist about all||
0491|140|P|the products you use (including prescription drugs,||
0491|141|P|nonprescription drugs, and herbal products).||
0491|142|P|   Older adults may be more sensitive to the side effects of this||
0491|143|P|drug, especially dizziness, confusion, unsteadiness, and||
0491|144|P|excessive drowsiness. These side effects can increase the risk of||
0491|145|P|falling.||
0491|146|P|   During pregnancy, this medication should be used only when||
0491|147|P|clearly needed. Infants born to mothers who take this medication||
0491|148|P|near the time of delivery may have undesirable effects such as||
0491|149|P|excessive sleepiness. Tell your doctor if you notice such effects||
0491|150|P|in your newborn. Discuss the risks and benefits with your doctor.||
0491|151|P|   It is unknown if this medication passes into breast milk.||
0491|152|P|However, similar drugs pass into breast milk. Consult your doctor||
0491|153|P|before breastfeeding.||
0491|154|B|||
0491|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0491|156|I|medications work or increase your risk for serious side effects.||
0491|157|I|This document does not contain all possible drug interactions.||
0491|158|I|Keep a list of all the products you use (including||
0491|159|I|prescription/nonprescription drugs and herbal products) and share||
0491|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
0491|161|I|the dosage of any medicines without your doctor's approval.||
0491|162|I|   A product that may interact with this drug is: sodium oxybate.||
0491|163|I|   Tell your doctor or pharmacist if you are taking other||
0491|164|I|products that cause drowsiness such as opioid pain or cough||
0491|165|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0491|166|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0491|167|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0491|168|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0491|169|I|diphenhydramine).||
0491|170|I|   Check the labels on all your medicines (such as allergy or||
0491|171|I|cough-and-cold products) because they may contain ingredients||
0491|172|I|that cause drowsiness. Ask your pharmacist about using those||
0491|173|I|products safely.||
0491|174|I|   Eszopiclone is very similar to zopiclone. Do not use||
0491|175|I|medications containing zopiclone while using eszopiclone.||
0491|176|B|||
0491|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0491|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0491|179|O|poison control center right away. US residents can call||
0491|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0491|181|O|Symptoms of overdose may include: slow/shallow breathing, a deep||
0491|182|O|sleep from which you cannot be awakened.||
0491|183|B|||
0491|184|N|NOTES:  Do not share this medication with others. Sharing it is||
0491|185|N|against the law.||
0491|186|N|   As you get older, your sleep pattern may naturally change and||
0491|187|N|your sleep may be interrupted several times during the night.||
0491|188|N|Consult your doctor or pharmacist for ways to improve your sleep||
0491|189|N|without medication, such as avoiding caffeine and alcohol close||
0491|190|N|to bedtime, avoiding daytime naps, and going to bed at the same||
0491|191|N|time each night.||
0491|192|B|||
0491|193|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
0491|194|D|time to sleep for 7 to 8 hours afterward. (See also How to Use||
0491|195|D|section.)||
0491|196|B|||
0491|197|R|STORAGE:  Store at room temperature away from light and moisture.||
0491|198|R|Do not store in the bathroom. Keep all medications away from||
0491|199|R|children and pets.||
0491|200|R|   Do not flush medications down the toilet or pour them into a||
0491|201|R|drain unless instructed to do so. Properly discard this product||
0491|202|R|when it is expired or no longer needed. Consult your pharmacist||
0491|203|R|or local waste disposal company.||
0491|204|B|||
0491|205|A|Information last revised May 2024.||
0491|206|A|Copyright(c) 2025 First Databank, Inc.||
0491|207|B|||
0493|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0493|002|Z|does NOT have all possible information about this product. This||
0493|003|Z|information does not assure that this product is safe, effective,||
0493|004|Z|or appropriate for you. This information is not individual||
0493|005|Z|medical advice and does not substitute for the advice of your||
0493|006|Z|health care professional. Always ask your health care||
0493|007|Z|professional for complete information about this product and your||
0493|008|Z|specific health needs.||
0493|009|B|||
0493|010|T|GALANTAMINE EXTENDED-RELEASE CAPSULE - ORAL||
0493|011|F|(ga-LAN-tuh-meen)||
0493|012|B|||
0493|013|C|COMMON BRAND NAME(S): Razadyne ER||
0493|014|B|||
0493|015|U|USES:  Galantamine is used to treat mild to moderate confusion||
0493|016|U|(dementia) related to Alzheimer's disease. It does not cure||
0493|017|U|Alzheimer's disease, but it may improve memory, awareness, and||
0493|018|U|the ability to perform daily functions. This medication works by||
0493|019|U|restoring the balance of certain natural substances||
0493|020|U|(neurotransmitters) in the brain.||
0493|021|B|||
0493|022|H|HOW TO USE:  Take this medication by mouth with food as directed||
0493|023|H|by your doctor, usually once daily in the morning with breakfast.||
0493|024|H|This medication may be taken on an empty stomach if necessary.||
0493|025|H|Drink plenty of fluids with this medication unless instructed||
0493|026|H|otherwise. The dosage is based on your medical condition and||
0493|027|H|response to treatment. To reduce your risk of side effects, your||
0493|028|H|doctor may direct you to start this medication at a low dose and||
0493|029|H|gradually increase your dose. Follow your doctor's instructions||
0493|030|H|carefully.||
0493|031|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
0493|032|H|Doing so can release all of the drug at once, increasing the risk||
0493|033|H|of side effects.||
0493|034|H|   If you stop taking galantamine for several days, consult your||
0493|035|H|doctor before restarting your medication. Your doctor may direct||
0493|036|H|you to restart this medication at a low dose.||
0493|037|H|   Use this medication regularly to get the most benefit from it.||
0493|038|H|To help you remember, take it at the same time each day.||
0493|039|H|   Do not increase your dose or use this drug more often or for||
0493|040|H|longer than prescribed. Your condition will not improve any||
0493|041|H|faster, and your risk of side effects will increase.||
0493|042|H|   It may take at least 4 weeks of continued use to get the full||
0493|043|H|benefit of this drug.||
0493|044|H|   Tell your doctor if your condition gets worse.||
0493|045|B|||
0493|046|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, dizziness, drowsiness,||
0493|047|S|loss of appetite, or weight loss may occur. If any of these||
0493|048|S|effects last or get worse, tell your doctor or pharmacist||
0493|049|S|promptly.||
0493|050|S|   Remember that this medication has been prescribed because your||
0493|051|S|doctor has judged that the benefit to you is greater than the||
0493|052|S|risk of side effects. Many people using this medication do not||
0493|053|S|have serious side effects.||
0493|054|S|   Tell your doctor right away if you have any serious side||
0493|055|S|effects, including: slow heartbeat, difficulty urinating.||
0493|056|S|   Get medical help right away if you have any very serious side||
0493|057|S|effects, including: seizures, black/bloody stools, vomit that||
0493|058|S|looks bloody or like coffee grounds, severe stomach/abdominal||
0493|059|S|pain, fast/irregular heartbeat, severe dizziness, fainting.||
0493|060|S|   A very serious allergic reaction to this drug is rare.||
0493|061|S|However, get medical help right away if you notice any symptoms||
0493|062|S|of a serious allergic reaction, including: rash, itching/swelling||
0493|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0493|064|S|breathing.||
0493|065|S|   This is not a complete list of possible side effects. If you||
0493|066|S|notice other effects not listed above, contact your doctor or||
0493|067|S|pharmacist.||
0493|068|S|   In the US -||
0493|069|S|   Call your doctor for medical advice about side effects. You||
0493|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0493|071|S|www.fda.gov/medwatch.||
0493|072|S|   In Canada - Call your doctor for medical advice about side||
0493|073|S|effects. You may report side effects to Health Canada at||
0493|074|S|1-866-234-2345.||
0493|075|B|||
0493|076|P|PRECAUTIONS:  Before taking galantamine, tell your doctor or||
0493|077|P|pharmacist if you are allergic to it; or to benzgalantamine or to||
0493|078|P|daffodil plants; or if you have any other allergies. This product||
0493|079|P|may contain inactive ingredients, which can cause allergic||
0493|080|P|reactions or other problems. Talk to your pharmacist for more||
0493|081|P|details.||
0493|082|P|   Before using this medication, tell your doctor or pharmacist||
0493|083|P|your medical history, especially of: liver problems, kidney||
0493|084|P|problems, stomach/intestinal problems (such as ulcers, bleeding),||
0493|085|P|heart problems (such as sick sinus syndrome, AV block,||
0493|086|P|arrhythmias), breathing/lung problems (such as asthma, chronic||
0493|087|P|obstructive pulmonary disease-COPD), seizures, problems urinating||
0493|088|P|(such as due to enlarged prostate).||
0493|089|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0493|090|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0493|091|P|machinery, or do anything that needs alertness until you can do||
0493|092|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0493|093|P|are using marijuana (cannabis).||
0493|094|P|   Galantamine may cause a condition that affects the heart||
0493|095|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0493|096|P|serious (rarely fatal) fast/irregular heartbeat and other||
0493|097|P|symptoms (such as severe dizziness, fainting) that need medical||
0493|098|P|attention right away.||
0493|099|P|   The risk of QT prolongation may be increased if you have||
0493|100|P|certain medical conditions or are taking other drugs that may||
0493|101|P|cause QT prolongation. Before using galantamine, tell your doctor||
0493|102|P|or pharmacist of all the drugs you take and if you have any of||
0493|103|P|the following conditions: certain heart problems (heart failure,||
0493|104|P|slow heartbeat, QT prolongation in the EKG), family history of||
0493|105|P|certain heart problems (QT prolongation in the EKG, sudden||
0493|106|P|cardiac death).||
0493|107|P|   Low levels of potassium or magnesium in the blood may also||
0493|108|P|increase your risk of QT prolongation. This risk may increase if||
0493|109|P|you use certain drugs (such as diuretics/"water pills") or if you||
0493|110|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0493|111|P|Talk to your doctor about using galantamine safely.||
0493|112|P|   Before having surgery, tell your doctor or dentist about all||
0493|113|P|the products you use (including prescription drugs,||
0493|114|P|nonprescription drugs, and herbal products).||
0493|115|P|   Older adults may be more sensitive to the side effects of this||
0493|116|P|drug, especially QT prolongation (see above).||
0493|117|P|   During pregnancy, this medication should be used only when||
0493|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
0493|119|P|   It is unknown if this drug passes into breast milk. Consult||
0493|120|P|your doctor before breastfeeding.||
0493|121|B|||
0493|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0493|123|I|medications work or increase your risk for serious side effects.||
0493|124|I|This document does not contain all possible drug interactions.||
0493|125|I|Keep a list of all the products you use (including||
0493|126|I|prescription/nonprescription drugs and herbal products) and share||
0493|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
0493|128|I|the dosage of any medicines without your doctor's approval.||
0493|129|I|   Other medications can affect the removal of galantamine from||
0493|130|I|your body, which may affect how galantamine works. Examples||
0493|131|I|include amitriptyline, azole antifungals (such as ketoconazole),||
0493|132|I|quinidine, SSRI antidepressants (such as paroxetine), among||
0493|133|I|others.||
0493|134|I|   Galantamine is very similar to benzgalantamine. Do not use||
0493|135|I|medications containing benzgalantamine while using galantamine.||
0493|136|B|||
0493|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0493|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0493|139|O|poison control center right away. US residents can call||
0493|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0493|141|O|Symptoms of overdose may include muscle weakness or twitching,||
0493|142|O|severe stomach cramping, slow or shallow breathing,||
0493|143|O|slow/fast/irregular heartbeat, fainting, and seizures.||
0493|144|B|||
0493|145|N|NOTES:  Do not share this medication with others.||
0493|146|N|   Lab and/or medical tests (such as weight monitoring) should be||
0493|147|N|done before you start taking this medication and while you are||
0493|148|N|taking it. Keep all medical and lab appointments. Consult your||
0493|149|N|doctor for more details.||
0493|150|B|||
0493|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0493|152|D|remember. If it is near the time of the next dose, skip the||
0493|153|D|missed dose. Take your next dose at the regular time. Do not||
0493|154|D|double the dose to catch up.||
0493|155|B|||
0493|156|R|STORAGE:  Store at room temperature away from light and moisture.||
0493|157|R|Do not store in the bathroom. Keep all medications away from||
0493|158|R|children and pets.||
0493|159|R|   Do not flush medications down the toilet or pour them into a||
0493|160|R|drain unless instructed to do so. Properly discard this product||
0493|161|R|when it is expired or no longer needed. Consult your pharmacist||
0493|162|R|or local waste disposal company.||
0493|163|B|||
0493|164|A|Information last revised March 2025.||
0493|165|A|Copyright(c) 2025 First Databank, Inc.||
0493|166|B|||
0494|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0494|002|Z|does NOT have all possible information about this product. This||
0494|003|Z|information does not assure that this product is safe, effective,||
0494|004|Z|or appropriate for you. This information is not individual||
0494|005|Z|medical advice and does not substitute for the advice of your||
0494|006|Z|health care professional. Always ask your health care||
0494|007|Z|professional for complete information about this product and your||
0494|008|Z|specific health needs.||
0494|009|B|||
0494|010|T|EXENATIDE - INJECTION||
0494|011|F|(ex-EN-a-tide)||
0494|012|B|||
0494|013|C|COMMON BRAND NAME(S): Byetta||
0494|014|B|||
0494|015|W|WARNING:  This medication can cause a certain type of thyroid||
0494|016|W|tumor (thyroid C-cell tumors) in rats. It is unknown if this||
0494|017|W|medication can cause similar tumors in humans. Talk with your||
0494|018|W|doctor about the benefits and risks of treatment with this||
0494|019|W|medication. Do not use this medication if you have a||
0494|020|W|personal/family history of a certain type of cancer (medullary||
0494|021|W|thyroid carcinoma) or a certain inherited disease (multiple||
0494|022|W|endocrine neoplasia syndrome type 2 or MEN 2). While using this||
0494|023|W|medication, tell your doctor right away if you notice any signs||
0494|024|W|of thyroid tumors, including an unusual growth or lump in the||
0494|025|W|neck, difficulty swallowing, shortness of breath, unusual/lasting||
0494|026|W|hoarseness.||
0494|027|B|||
0494|028|U|USES:  Exenatide is used with a proper diet and exercise program||
0494|029|U|to control high blood sugar. It is used by people with type 2||
0494|030|U|diabetes. Controlling high blood sugar helps prevent kidney||
0494|031|U|damage, blindness, nerve problems, loss of limbs, and sexual||
0494|032|U|function problems. Proper control of diabetes may also lessen||
0494|033|U|your risk of a heart attack or stroke.||
0494|034|U|   Exenatide is a diabetes drug that is similar to a natural||
0494|035|U|hormone in your body (incretin). It works by increasing insulin||
0494|036|U|release (especially after a meal) and decreasing the amount of||
0494|037|U|sugar your liver makes. It also slows down food digestion in your||
0494|038|U|stomach, decreases the amount of sugar absorbed from food, and||
0494|039|U|may help decrease your appetite.||
0494|040|B|||
0494|041|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
0494|042|H|provided by your pharmacist before you start using exenatide and||
0494|043|H|each time you get a refill. Ask your health care professional how||
0494|044|H|to prepare and use this medication. If you have any questions,||
0494|045|H|ask your doctor or pharmacist.||
0494|046|H|   Inject this medication under the skin as directed by your||
0494|047|H|doctor, usually twice a day. Injection should be done within 60||
0494|048|H|minutes before the morning and evening meals (or before the two||
0494|049|H|main meals of the day, at least 6 hours apart). Exenatide should||
0494|050|H|not be used after a meal since it will not work as well. The||
0494|051|H|injection is given in the thigh, abdomen, or upper arm. The||
0494|052|H|dosage is based on your medical condition and response to||
0494|053|H|treatment.||
0494|054|H|   Before using, check this product for particles or||
0494|055|H|discoloration. If either is present, do not use the liquid.||
0494|056|H|Before injecting each dose, clean the skin you are going to||
0494|057|H|inject into (the injection site) with rubbing alcohol. Change the||
0494|058|H|injection site each time to lessen injury under the skin. If you||
0494|059|H|are also using insulin, give exenatide and insulin as separate||
0494|060|H|injections. Do not mix them. You may inject these medications in||
0494|061|H|the same area of the body, but the injection sites should not be||
0494|062|H|next to each other. To lessen bruising, do not rub the injection||
0494|063|H|site after a shot. Learn how to store and discard medical||
0494|064|H|supplies safely.||
0494|065|H|   Since exenatide slows down digestion of food/drugs in your||
0494|066|H|stomach, certain medications (such as birth control pills,||
0494|067|H|antibiotics taken by mouth) may not work as well if you take them||
0494|068|H|at the same time. Take birth control pills or antibiotics at||
0494|069|H|least 1 hour before using exenatide. If you must take these||
0494|070|H|medications with food, take them with a meal or snack when you do||
0494|071|H|not also take exenatide. Ask your doctor or pharmacist if you||
0494|072|H|have any questions about when to take your medications.||
0494|073|H|   Use this medication regularly to get the most benefit from it.||
0494|074|H|To help you remember, use it at the same times each day.||
0494|075|H|   Do not share your pen device with another person, even if the||
0494|076|H|needle is changed. You may give other people a serious infection,||
0494|077|H|or get a serious infection from them.||
0494|078|H|   Tell your doctor if your condition does not get better or if||
0494|079|H|it gets worse (your blood sugar is too high or too low).||
0494|080|B|||
0494|081|S|SIDE EFFECTS:  See also Warning section.||
0494|082|S|   Nausea, vomiting, diarrhea, nervousness, or upset stomach may||
0494|083|S|occur as your body adjusts to the medication. Nausea usually||
0494|084|S|lessens as you continue to use exenatide. Other side effects||
0494|085|S|include decreased appetite or weight loss. If any of these||
0494|086|S|effects last or get worse, tell your doctor or pharmacist||
0494|087|S|promptly.||
0494|088|S|   Remember that this medication has been prescribed because your||
0494|089|S|doctor has judged that the benefit to you is greater than the||
0494|090|S|risk of side effects. Many people using this medication do not||
0494|091|S|have serious side effects.||
0494|092|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
0494|093|S|Contact your doctor promptly if you notice any symptoms of||
0494|094|S|dehydration, such as unusual dry mouth/thirst, fast heartbeat, or||
0494|095|S|dizziness/lightheadedness.||
0494|096|S|   Exenatide does not usually cause low blood sugar||
0494|097|S|(hypoglycemia). Low blood sugar may occur if this drug is||
0494|098|S|prescribed with other diabetes medications, or if you do not get||
0494|099|S|enough calories from food, or if you do unusually heavy exercise.||
0494|100|S|Talk with your doctor or pharmacist about whether the dose of||
0494|101|S|your other diabetes medication(s) needs to be lowered. Symptoms||
0494|102|S|of low blood sugar include sudden sweating, shaking, fast||
0494|103|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
0494|104|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
0494|105|S|treat low blood sugar. If you don't have these reliable forms of||
0494|106|S|glucose, rapidly raise your blood sugar by eating a quick source||
0494|107|S|of sugar such as table sugar, honey, or candy, or drink fruit||
0494|108|S|juice or non-diet soda. Tell your doctor right away about the||
0494|109|S|reaction and the use of this product. To help prevent low blood||
0494|110|S|sugar, eat meals on a regular schedule, and do not skip meals.||
0494|111|S|Check with your doctor or pharmacist to find out what you should||
0494|112|S|do if you miss a meal.||
0494|113|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0494|114|S|thirst/urination. If these symptoms occur, tell your doctor right||
0494|115|S|away. Your doctor may need to adjust your diabetes medication,||
0494|116|S|exercise program, or diet.||
0494|117|S|   Tell your doctor right away if you have any serious side||
0494|118|S|effects, including: signs of kidney problems (such as change in||
0494|119|S|the amount of urine), easy bruising/bleeding.||
0494|120|S|   Get medical help right away if you have any very serious side||
0494|121|S|effects, including: signs of pancreas or gallbladder disease||
0494|122|S|(such as nausea/vomiting that doesn't stop, severe||
0494|123|S|stomach/abdominal pain).||
0494|124|S|   A very serious allergic reaction to this drug is rare.||
0494|125|S|However, get medical help right away if you notice any symptoms||
0494|126|S|of a serious allergic reaction, including: rash, itching/swelling||
0494|127|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0494|128|S|breathing.||
0494|129|S|   This is not a complete list of possible side effects. If you||
0494|130|S|notice other effects not listed above, contact your doctor or||
0494|131|S|pharmacist.||
0494|132|S|   In the US -||
0494|133|S|   Call your doctor for medical advice about side effects. You||
0494|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0494|135|S|www.fda.gov/medwatch.||
0494|136|S|   In Canada - Call your doctor for medical advice about side||
0494|137|S|effects. You may report side effects to Health Canada at||
0494|138|S|1-866-234-2345.||
0494|139|B|||
0494|140|P|PRECAUTIONS:  See also Warning section.||
0494|141|P|   Before using exenatide, tell your doctor or pharmacist if you||
0494|142|P|are allergic to it; or if you have any other allergies. This||
0494|143|P|product may contain inactive ingredients, which can cause||
0494|144|P|allergic reactions or other problems. Talk to your pharmacist for||
0494|145|P|more details.||
0494|146|P|   Before using this medication, tell your doctor or pharmacist||
0494|147|P|your medical history, especially of: stomach/intestinal disorders||
0494|148|P|(such as gastroparesis, digestion problems), kidney disease,||
0494|149|P|disease of the pancreas (pancreatitis), gallbladder disease, a||
0494|150|P|certain blood disorder from exenatide (drug-induced||
0494|151|P|thrombocytopenia).||
0494|152|P|   You may experience blurred vision, dizziness, or drowsiness||
0494|153|P|due to extremely low or high blood sugar. Do not drive, use||
0494|154|P|machinery, or do anything that needs alertness or clear vision||
0494|155|P|until you can do it safely.||
0494|156|P|   Limit alcohol while taking this medication because it can||
0494|157|P|increase your risk of developing low blood sugar.||
0494|158|P|   It may be harder to control your blood sugar when your body is||
0494|159|P|stressed (such as due to fever, infection, injury, or surgery).||
0494|160|P|Consult your doctor because this may require a change in your||
0494|161|P|treatment plan, medications, or blood sugar testing.||
0494|162|P|   Before having surgery, tell your doctor or dentist about all||
0494|163|P|the products you use (including prescription drugs,||
0494|164|P|nonprescription drugs, and herbal products).||
0494|165|P|   During pregnancy, this medication should be used only when||
0494|166|P|clearly needed. Discuss the risks and benefits with your doctor.||
0494|167|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
0494|168|P|your doctor for managing your blood sugar while pregnant. Your||
0494|169|P|doctor may change your diabetes treatment during your pregnancy||
0494|170|P|(such as diet and medications including insulin).||
0494|171|P|   It is unknown if this medication passes into breast milk, but||
0494|172|P|it is unlikely to harm a nursing infant. Consult your doctor||
0494|173|P|before breastfeeding.||
0494|174|B|||
0494|175|I|DRUG INTERACTIONS:  See also How to Use section.||
0494|176|I|   Drug interactions may change how your medications work or||
0494|177|I|increase your risk for serious side effects. This document does||
0494|178|I|not contain all possible drug interactions. Keep a list of all||
0494|179|I|the products you use (including prescription/nonprescription||
0494|180|I|drugs and herbal products) and share it with your doctor and||
0494|181|I|pharmacist. Do not start, stop, or change the dosage of any||
0494|182|I|medicines without your doctor's approval.||
0494|183|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0494|184|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0494|185|I|heartbeat you would usually feel when your blood sugar falls too||
0494|186|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0494|187|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0494|188|I|   Many drugs can affect your blood sugar, making it harder to||
0494|189|I|control. Before you start, stop, or change any medication, talk||
0494|190|I|with your doctor or pharmacist about how the medication may||
0494|191|I|affect your blood sugar. Check your blood sugar regularly as||
0494|192|I|directed and share the results with your doctor. Tell your doctor||
0494|193|I|right away if you have symptoms of high or low blood sugar. (See||
0494|194|I|also Side Effects section.) Your doctor may need to adjust your||
0494|195|I|diabetes medication, exercise program, or diet.||
0494|196|B|||
0494|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0494|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0494|199|O|poison control center right away. US residents can call||
0494|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0494|201|B|||
0494|202|N|NOTES:  Do not share this medication with others.||
0494|203|N|   Attend a diabetes education program to learn more about||
0494|204|N|diabetes and the important parts of its treatment, including||
0494|205|N|medications, diet, exercise, and having regular eye/foot/medical||
0494|206|N|exams.||
0494|207|N|   Learn the symptoms of high and low blood sugar and how to||
0494|208|N|treat low blood sugar. Check your blood sugar regularly as||
0494|209|N|directed and share the results with your doctor.||
0494|210|N|   Lab and/or medical tests (such as kidney function, blood||
0494|211|N|glucose, hemoglobin A1c) should be done before you start using||
0494|212|N|this medication and while you are using it. Keep all medical and||
0494|213|N|lab appointments. Consult your doctor for more details.||
0494|214|B|||
0494|215|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0494|216|D|If it is near the time of the next dose, skip the missed dose.||
0494|217|D|Use your next dose at the regular time. Do not double the dose to||
0494|218|D|catch up.||
0494|219|B|||
0494|220|R|STORAGE:  Store the unused pen injector in the refrigerator. Do||
0494|221|R|not freeze. Once used, this product may be stored in the||
0494|222|R|refrigerator or at room temperature away from light. Discard the||
0494|223|R|used pen injector after 30 days. Keep all medications away from||
0494|224|R|children and pets.||
0494|225|R|   Do not flush medications down the toilet or pour them into a||
0494|226|R|drain unless instructed to do so. Properly discard this product||
0494|227|R|when it is expired or no longer needed. Consult your pharmacist||
0494|228|R|or local waste disposal company.||
0494|229|B|||
0494|230|M|MEDICAL ALERT:  Your condition can cause complications in a||
0494|231|M|medical emergency. For information about enrolling in MedicAlert,||
0494|232|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0494|233|B|||
0494|234|A|Information last revised November 2025.||
0494|235|A|Copyright(c) 2025 First Databank, Inc.||
0494|236|B|||
0495|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0495|002|Z|does NOT have all possible information about this product. This||
0495|003|Z|information does not assure that this product is safe, effective,||
0495|004|Z|or appropriate for you. This information is not individual||
0495|005|Z|medical advice and does not substitute for the advice of your||
0495|006|Z|health care professional. Always ask your health care||
0495|007|Z|professional for complete information about this product and your||
0495|008|Z|specific health needs.||
0495|009|B|||
0495|010|T|MICAFUNGIN - INJECTION||
0495|011|F|(MYE-ka-FUN-jin)||
0495|012|B|||
0495|013|C|COMMON BRAND NAME(S): Mycamine||
0495|014|B|||
0495|015|U|USES:  This medication is used to treat a variety of fungal||
0495|016|U|infections. It is also used to prevent fungal infections in||
0495|017|U|patients who are having a stem cell transplant. Micafungin||
0495|018|U|belongs to a class of drugs known as echinocandins. It works by||
0495|019|U|stopping the growth of fungi.||
0495|020|B|||
0495|021|H|HOW TO USE:  This medication is given by injection into a vein as||
0495|022|H|directed by your doctor, usually once a day over 1 hour. The||
0495|023|H|dosage and length of treatment are based on your medical||
0495|024|H|condition and response to treatment. Children's dosage is also||
0495|025|H|based on weight.||
0495|026|H|   If you are using this medication at home, learn all||
0495|027|H|preparation and usage instructions from your health care||
0495|028|H|professional. Before using, check this product for particles or||
0495|029|H|discoloration. If either is present, do not use the liquid.||
0495|030|H|   Learn how to store and discard medical supplies safely.||
0495|031|H|   Infusion reactions may happen during the infusion of this||
0495|032|H|drug. Tell your doctor right away if you have any symptoms of||
0495|033|H|infusion reactions such as flushing or dizziness.||
0495|034|H|   Continue to use this medication until the full prescribed||
0495|035|H|amount is finished, even if symptoms disappear after a few days.||
0495|036|H|Stopping the medication too early may result in a return of the||
0495|037|H|infection.||
0495|038|H|   Tell your doctor if your condition does not get better or if||
0495|039|H|it gets worse.||
0495|040|B|||
0495|041|S|SIDE EFFECTS:  See also How to Use section.||
0495|042|S|   Swelling/redness/irritation at the injection site,||
0495|043|S|nausea/vomiting, diarrhea, headache, or trouble sleeping may||
0495|044|S|occur. If any of these effects last or get worse, tell your||
0495|045|S|doctor or pharmacist promptly.||
0495|046|S|   Remember that this medication has been prescribed because your||
0495|047|S|doctor has judged that the benefit to you is greater than the||
0495|048|S|risk of side effects. Many people using this medication do not||
0495|049|S|have serious side effects.||
0495|050|S|   Tell your doctor right away if you have any serious side||
0495|051|S|effects, including: signs of liver disease (such as||
0495|052|S|nausea/vomiting that doesn't stop, loss of appetite, dark urine,||
0495|053|S|stomach/abdominal pain, yellowing eyes/skin), signs of kidney||
0495|054|S|problems (such as change in the amount of urine), unusual||
0495|055|S|tiredness, shortness of breath, signs of infection (such as sore||
0495|056|S|throat that doesn't go away, fever, chills), easy||
0495|057|S|bleeding/bruising, mental/mood changes (such as anxiety),||
0495|058|S|fast/irregular heartbeat.||
0495|059|S|   A very serious allergic reaction to this drug is rare.||
0495|060|S|However, get medical help right away if you notice any symptoms||
0495|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0495|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0495|063|S|breathing.||
0495|064|S|   This is not a complete list of possible side effects. If you||
0495|065|S|notice other effects not listed above, contact your doctor or||
0495|066|S|pharmacist.||
0495|067|S|   In the US -||
0495|068|S|   Call your doctor for medical advice about side effects. You||
0495|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0495|070|S|www.fda.gov/medwatch.||
0495|071|S|   In Canada - Call your doctor for medical advice about side||
0495|072|S|effects. You may report side effects to Health Canada at||
0495|073|S|1-866-234-2345.||
0495|074|B|||
0495|075|P|PRECAUTIONS:  Before using micafungin, tell your doctor or||
0495|076|P|pharmacist if you are allergic to it; or to other echinocandin||
0495|077|P|antifungal drugs (such as anidulafungin, caspofungin); or if you||
0495|078|P|have any other allergies. This product may contain inactive||
0495|079|P|ingredients, which can cause allergic reactions or other||
0495|080|P|problems. Talk to your pharmacist for more details.||
0495|081|P|   Before using this medication, tell your doctor or pharmacist||
0495|082|P|your medical history, especially of: liver disease, kidney||
0495|083|P|disease.||
0495|084|P|   Some brands of this medication contain sodium. Before using||
0495|085|P|this medication, tell your doctor or pharmacist if you are on a||
0495|086|P|salt-restricted diet or if you have a condition that could be||
0495|087|P|worsened by an increase in salt intake (such as heart failure).||
0495|088|P|   Before having surgery, tell your doctor or dentist about all||
0495|089|P|the products you use (including prescription drugs,||
0495|090|P|nonprescription drugs, and herbal products).||
0495|091|P|   During pregnancy, this medication should be used only when||
0495|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
0495|093|P|   It is unknown if this drug passes into breast milk. Consult||
0495|094|P|your doctor before breastfeeding.||
0495|095|B|||
0495|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0495|097|I|medications work or increase your risk for serious side effects.||
0495|098|I|This document does not contain all possible drug interactions.||
0495|099|I|Keep a list of all the products you use (including||
0495|100|I|prescription/nonprescription drugs and herbal products) and share||
0495|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0495|102|I|the dosage of any medicines without your doctor's approval.||
0495|103|B|||
0495|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0495|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0495|106|O|poison control center right away. US residents can call||
0495|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0495|108|B|||
0495|109|N|NOTES:  Lab and/or medical tests (such as liver/kidney function,||
0495|110|N|complete blood count) should be done while you are using this||
0495|111|N|medication. Keep all medical and lab appointments. Consult your||
0495|112|N|doctor for more details.||
0495|113|B|||
0495|114|D|MISSED DOSE:  It is important to get each dose of this medication||
0495|115|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0495|116|D|right away for a new dosing schedule. Do not double the dose to||
0495|117|D|catch up.||
0495|118|B|||
0495|119|R|STORAGE:  Consult the product instructions and your pharmacist||
0495|120|R|for storage details. Keep all medications away from children and||
0495|121|R|pets.||
0495|122|R|   Do not flush medications down the toilet or pour them into a||
0495|123|R|drain unless instructed to do so. Properly discard this product||
0495|124|R|when it is expired or no longer needed. Consult your pharmacist||
0495|125|R|or local waste disposal company.||
0495|126|B|||
0495|127|A|Information last revised April 2025.||
0495|128|A|Copyright(c) 2025 First Databank, Inc.||
0495|129|B|||
0497|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0497|002|Z|does NOT have all possible information about this product. This||
0497|003|Z|information does not assure that this product is safe, effective,||
0497|004|Z|or appropriate for you. This information is not individual||
0497|005|Z|medical advice and does not substitute for the advice of your||
0497|006|Z|health care professional. Always ask your health care||
0497|007|Z|professional for complete information about this product and your||
0497|008|Z|specific health needs.||
0497|009|B|||
0497|010|T|CYCLOPHOSPHAMIDE - INJECTION||
0497|011|F|(sye-klo-FOSS-fuh-mide)||
0497|012|B|||
0497|013|C|COMMON BRAND NAME(S): Cytoxan||
0497|014|B|||
0497|015|U|USES:  Cyclophosphamide is used to treat various types of cancer.||
0497|016|U|It is a chemotherapy drug that works by slowing or stopping cell||
0497|017|U|growth.||
0497|018|U|   Cyclophosphamide also works by decreasing your immune system's||
0497|019|U|response to various diseases. It is used to treat a certain type||
0497|020|U|of kidney disease in children after other treatments have not||
0497|021|U|worked.||
0497|022|B|||
0497|023|V|OTHER USES:  This section contains uses of this drug that are not||
0497|024|V|listed in the approved professional labeling for the drug but||
0497|025|V|that may be prescribed by your health care professional. Use this||
0497|026|V|drug for a condition that is listed in this section only if it||
0497|027|V|has been so prescribed by your health care professional.||
0497|028|V|   This medication may also be used for various conditions such||
0497|029|V|as lupus and multiple sclerosis.||
0497|030|B|||
0497|031|H|HOW TO USE:  This medication is usually given by injection into a||
0497|032|H|vein by a health care professional. The dosage is based on your||
0497|033|H|medical condition, weight, response to treatment, and other||
0497|034|H|treatments (such as other chemotherapy drugs, radiation) you may||
0497|035|H|be receiving. Be sure to tell your doctor and pharmacist about||
0497|036|H|all the products you use (including prescription drugs,||
0497|037|H|nonprescription drugs, and herbal products).||
0497|038|H|   During treatment with this medication, it is important that||
0497|039|H|you take in more fluids than usual and pass urine often to help||
0497|040|H|avoid kidney and bladder side effects. Intravenous fluids should||
0497|041|H|be given with this medication. Also, ask your doctor how much||
0497|042|H|fluid you should drink and how often to empty your bladder each||
0497|043|H|day, and follow these instructions carefully.||
0497|044|B|||
0497|045|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, stomach ache,||
0497|046|S|diarrhea, or darkening of the skin/nails may occur. Nausea and||
0497|047|S|vomiting can be severe. In some cases, drug therapy may be||
0497|048|S|necessary to prevent or relieve nausea and vomiting. Changes in||
0497|049|S|diet such as eating several small meals or limiting activity may||
0497|050|S|help lessen some of these effects. If any of these effects last||
0497|051|S|or get worse, tell your doctor or pharmacist promptly.||
0497|052|S|   Although these effects are uncommon, immediately report any||
0497|053|S|pain, swelling, or redness at the injection site.||
0497|054|S|   Temporary hair loss may occur. Hair growth should return after||
0497|055|S|treatment has ended or may even return during treatment. However,||
0497|056|S|new hair may have a different color or texture.||
0497|057|S|   People using this medication may have serious side effects.||
0497|058|S|However, you have been prescribed this drug because your doctor||
0497|059|S|has judged that the benefit to you is greater than the risk of||
0497|060|S|side effects. Careful monitoring by your doctor may decrease your||
0497|061|S|risk.||
0497|062|S|   Tell your doctor right away if you have any serious side||
0497|063|S|effects, including: signs of kidney or bladder problems (such as||
0497|064|S|change in the amount of urine, pink/bloody urine), mouth sores,||
0497|065|S|joint pain, stopping of menstrual periods, existing wounds that||
0497|066|S|are slow healing, black/bloody stools, signs of liver problems||
0497|067|S|(such as stomach/abdominal pain, yellowing eyes/skin, dark||
0497|068|S|urine), mental/mood changes, muscle weakness/spasm.||
0497|069|S|   This medication may rarely cause very serious effects on the||
0497|070|S|heart, especially when used in high doses, or in combination with||
0497|071|S|radiation treatment or certain other chemotherapy drugs (such as||
0497|072|S|doxorubicin). Get medical help right away if you develop: chest||
0497|073|S|pain, jaw/left arm pain, trouble breathing, irregular heartbeat,||
0497|074|S|symptoms of heart failure (such as shortness of breath, swelling||
0497|075|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
0497|076|S|   This medication decreases bone marrow function, an effect that||
0497|077|S|may lead to a low number of blood cells such as red cells, white||
0497|078|S|cells, and platelets. This effect can cause anemia, decrease your||
0497|079|S|body's ability to fight an infection, or cause easy||
0497|080|S|bruising/bleeding. Tell your doctor right away if you develop any||
0497|081|S|of the following symptoms: unusual tiredness, pale skin, signs of||
0497|082|S|infection (such as sore throat that doesn't go away, fever,||
0497|083|S|chills), easy bruising/bleeding.||
0497|084|S|   Cyclophosphamide may lessen the chance of having children in||
0497|085|S|both men and women. Sterility is usually temporary with this||
0497|086|S|medication, but can be permanent in some cases. Consult your||
0497|087|S|doctor for more details.||
0497|088|S|   Although cyclophosphamide is used to treat cancer, in some||
0497|089|S|patients it may increase the risk of developing another form of||
0497|090|S|cancer, sometimes months to years after treatment. Consult your||
0497|091|S|doctor for more details. It is important to be closely monitored||
0497|092|S|by your doctor during treatment. You should also see your doctor||
0497|093|S|regularly after treatment is finished. Tell your doctor right||
0497|094|S|away if you develop: unusual growths or lumps, swollen lymph||
0497|095|S|nodes, unexplained or sudden weight loss, night sweats, pain in||
0497|096|S|the pelvis, painful or frequent urination.||
0497|097|S|   A very serious allergic reaction to this drug is rare.||
0497|098|S|However, get medical help right away if you notice any symptoms||
0497|099|S|of a serious allergic reaction, including: rash, itching/swelling||
0497|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0497|101|S|breathing.||
0497|102|S|   This is not a complete list of possible side effects. If you||
0497|103|S|notice other effects not listed above, contact your doctor or||
0497|104|S|pharmacist.||
0497|105|S|   In the US -||
0497|106|S|   Call your doctor for medical advice about side effects. You||
0497|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0497|108|S|www.fda.gov/medwatch.||
0497|109|S|   In Canada - Call your doctor for medical advice about side||
0497|110|S|effects. You may report side effects to Health Canada at||
0497|111|S|1-866-234-2345.||
0497|112|B|||
0497|113|P|PRECAUTIONS:  Before using cyclophosphamide, tell your doctor or||
0497|114|P|pharmacist if you are allergic to it; or to other chemotherapy||
0497|115|P|drugs (such as busulfan, chlorambucil); or if you have any other||
0497|116|P|allergies. This product may contain inactive ingredients (such as||
0497|117|P|alcohol), which can cause allergic reactions or other problems.||
0497|118|P|Talk to your pharmacist for more details.||
0497|119|P|   Before using this medication, tell your doctor or pharmacist||
0497|120|P|your medical history, especially of: decreased bone marrow||
0497|121|P|function (such as anemia, leukopenia, thrombocytopenia), liver||
0497|122|P|disease, kidney disease, difficulty urinating (for example, due||
0497|123|P|to blockage), surgery to remove your adrenal glands.||
0497|124|P|   Cyclophosphamide can make you more likely to get infections or||
0497|125|P|may make current infections worse. Stay away from anyone who has||
0497|126|P|an infection that may easily spread (such as chickenpox,||
0497|127|P|COVID-19, measles, flu). Talk to your doctor if you have been||
0497|128|P|exposed to an infection or for more details.||
0497|129|P|   Tell your health care professional that you are using||
0497|130|P|cyclophosphamide before having any immunizations/vaccinations.||
0497|131|P|Avoid contact with people who have recently received live||
0497|132|P|vaccines (such as flu vaccine inhaled through the nose).||
0497|133|P|   To lower the chance of getting cut, bruised, or injured, use||
0497|134|P|caution with sharp objects like razors and nail cutters, and||
0497|135|P|avoid activities such as contact sports.||
0497|136|P|   Before having surgery, tell your doctor or dentist about all||
0497|137|P|the products you use (including prescription drugs,||
0497|138|P|nonprescription drugs, and herbal products).||
0497|139|P|   Children may be more sensitive to the side effects of this||
0497|140|P|drug, especially possible infertility later in life.||
0497|141|P|   Tell your doctor if you are pregnant or plan to become||
0497|142|P|pregnant. You should not become pregnant while using||
0497|143|P|cyclophosphamide. Cyclophosphamide may harm an unborn baby. Your||
0497|144|P|doctor should order a pregnancy test before you start this||
0497|145|P|medication. Women using this medication should ask about reliable||
0497|146|P|forms of birth control during treatment and for 1 year after the||
0497|147|P|last dose. Men using this medication should ask about reliable||
0497|148|P|forms of birth control during treatment and for 4 months after||
0497|149|P|the last dose. If you or your partner becomes pregnant, talk to||
0497|150|P|your doctor right away about the risks and benefits of this||
0497|151|P|medication.||
0497|152|P|   This drug passes into breast milk and may harm a nursing||
0497|153|P|infant. Breastfeeding is not recommended while using this drug||
0497|154|P|and for 1 week after the last dose. Consult your doctor before||
0497|155|P|breastfeeding.||
0497|156|B|||
0497|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0497|158|I|medications work or increase your risk for serious side effects.||
0497|159|I|This document does not contain all possible drug interactions.||
0497|160|I|Keep a list of all the products you use (including||
0497|161|I|prescription/nonprescription drugs and herbal products) and share||
0497|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
0497|163|I|the dosage of any medicines without your doctor's approval.||
0497|164|I|   Some products that may interact with this drug include:||
0497|165|I|azathioprine, etanercept, turmeric (curcumin), voclosporin.||
0497|166|B|||
0497|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0497|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0497|169|O|poison control center right away. US residents can call||
0497|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0497|171|B|||
0497|172|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
0497|173|N|urine tests) should be done while you are using this medication.||
0497|174|N|Keep all medical and lab appointments. Consult your doctor for||
0497|175|N|more details.||
0497|176|B|||
0497|177|D|MISSED DOSE:  It is important to get each dose of this medication||
0497|178|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0497|179|D|right away for a new dosing schedule.||
0497|180|B|||
0497|181|R|STORAGE:  Consult the product instructions and your pharmacist||
0497|182|R|for storage details. Keep all medications away from children and||
0497|183|R|pets.||
0497|184|R|   Do not flush medications down the toilet or pour them into a||
0497|185|R|drain unless instructed to do so. Properly discard this product||
0497|186|R|when it is expired or no longer needed. Consult your pharmacist||
0497|187|R|or local waste disposal company.||
0497|188|B|||
0497|189|M|MEDICAL ALERT:  Your condition can cause complications in a||
0497|190|M|medical emergency. For information about enrolling in MedicAlert,||
0497|191|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0497|192|B|||
0497|193|A|Information last revised May 2025.||
0497|194|A|Copyright(c) 2025 First Databank, Inc.||
0497|195|B|||
0499|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0499|002|Z|does NOT have all possible information about this product. This||
0499|003|Z|information does not assure that this product is safe, effective,||
0499|004|Z|or appropriate for you. This information is not individual||
0499|005|Z|medical advice and does not substitute for the advice of your||
0499|006|Z|health care professional. Always ask your health care||
0499|007|Z|professional for complete information about this product and your||
0499|008|Z|specific health needs.||
0499|009|B|||
0499|010|T|LEVOFLOXACIN SOLUTION - ORAL||
0499|011|F|(LEE-voe-FLOX-a-sin)||
0499|012|B|||
0499|013|C|COMMON BRAND NAME(S): Levaquin||
0499|014|B|||
0499|015|W|WARNING:  Quinolone antibiotics (including levofloxacin) may||
0499|016|W|cause serious and possibly permanent tendon damage (such as||
0499|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
0499|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
0499|019|W|help right away if you have any of the following symptoms:||
0499|020|W|pain/numbness/burning/tingling/weakness in your||
0499|021|W|arms/hands/legs/feet, changes in how you sense||
0499|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
0499|023|W|headache, vision changes, shaking (tremors), seizures,||
0499|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
0499|025|W|hallucinations, depression, rare thoughts of suicide).||
0499|026|W|   Tendon damage may occur during or after treatment with this||
0499|027|W|medication. Stop exercising, rest, and get medical help right||
0499|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
0499|029|W|risk for tendon problems is greater if you are over 60 years of||
0499|030|W|age, if you are taking corticosteroids (such as prednisone), or||
0499|031|W|if you have a kidney, heart, or lung transplant.||
0499|032|W|   This medication may make a certain muscle condition||
0499|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
0499|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
0499|035|W|unsteady walk) or trouble breathing.||
0499|036|W|   Discuss the risks and benefits with your doctor before using||
0499|037|W|this medication.||
0499|038|B|||
0499|039|U|USES:  Levofloxacin is used to treat a variety of bacterial||
0499|040|U|infections. This medication belongs to a class of drugs known as||
0499|041|U|quinolone antibiotics. It works by stopping the growth of||
0499|042|U|bacteria.||
0499|043|U|   This antibiotic treats only bacterial infections. It will not||
0499|044|U|work for viral infections (such as common cold, flu). Using any||
0499|045|U|antibiotic when it is not needed can cause it to not work for||
0499|046|U|future infections.||
0499|047|B|||
0499|048|H|HOW TO USE:  Read the Medication Guide provided by your||
0499|049|H|pharmacist before you start taking levofloxacin and each time you||
0499|050|H|get a refill. If you have any questions, ask your doctor or||
0499|051|H|pharmacist.||
0499|052|H|   Take this medication by mouth on an empty stomach (1 hour||
0499|053|H|before or 2 hours after eating) as directed by your doctor,||
0499|054|H|usually once daily. Drink plenty of fluids while taking this||
0499|055|H|medication unless otherwise directed by your doctor.||
0499|056|H|   Take this medication at least 2 hours before or 2 hours after||
0499|057|H|taking other products that may make it work less well. Some||
0499|058|H|examples include: quinapril, sucralfate, vitamins/minerals||
0499|059|H|(including iron, zinc), and products that contain magnesium,||
0499|060|H|aluminum, or calcium (such as antacids, juice with added||
0499|061|H|calcium). Ask your pharmacist about all the products you take.||
0499|062|H|   Carefully measure the dose using a special measuring||
0499|063|H|device/spoon. Do not use a household spoon because you may not||
0499|064|H|get the correct dose.||
0499|065|H|   The dosage and length of treatment are based on your medical||
0499|066|H|condition and response to treatment. Children's dosage is also||
0499|067|H|based on weight.||
0499|068|H|   For the best effect, take this antibiotic at evenly spaced||
0499|069|H|times. To help you remember, take this medication at the same||
0499|070|H|time every day.||
0499|071|H|   Continue to take this medication until the full prescribed||
0499|072|H|amount is finished, even if symptoms disappear after a few days.||
0499|073|H|Stopping the medication too early may result in a return of the||
0499|074|H|infection.||
0499|075|H|   Tell your doctor if your condition lasts or gets worse.||
0499|076|B|||
0499|077|S|SIDE EFFECTS:  See also Warning section.||
0499|078|S|   Nausea, diarrhea, headache, dizziness, lightheadedness, or||
0499|079|S|trouble sleeping may occur. If any of these effects last or get||
0499|080|S|worse, tell your doctor or pharmacist promptly.||
0499|081|S|   Remember that this medication has been prescribed because your||
0499|082|S|doctor has judged that the benefit to you is greater than the||
0499|083|S|risk of side effects. Many people using this medication do not||
0499|084|S|have serious side effects.||
0499|085|S|   Tell your doctor right away if you have any serious side||
0499|086|S|effects, including: unusual bruising/bleeding, signs of kidney||
0499|087|S|problems (such as change in the amount of urine), signs of liver||
0499|088|S|problems (such as nausea/vomiting that doesn't stop, loss of||
0499|089|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0499|090|S|urine).||
0499|091|S|   Get medical help right away if you have any very serious side||
0499|092|S|effects, including: chest pain, severe dizziness, fainting,||
0499|093|S|fast/irregular heartbeat, signs of a tear/break in the main blood||
0499|094|S|vessel called the aorta (such as sudden/severe pain in the||
0499|095|S|stomach/chest/back, shortness of breath).||
0499|096|S|   This medication may rarely cause a severe intestinal condition||
0499|097|S|due to a bacteria called C. difficile. This condition may occur||
0499|098|S|during treatment or weeks to months after treatment has stopped.||
0499|099|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0499|100|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0499|101|S|stool.||
0499|102|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0499|103|S|products because they may make symptoms worse.||
0499|104|S|   Use of this medication for prolonged or repeated periods may||
0499|105|S|result in oral thrush or a new yeast infection. Contact your||
0499|106|S|doctor if you notice white patches in your mouth, a change in||
0499|107|S|vaginal discharge, or other new symptoms.||
0499|108|S|   A very serious allergic reaction to this drug is rare.||
0499|109|S|However, get medical help right away if you notice any symptoms||
0499|110|S|of a serious allergic reaction, including: rash, itching/swelling||
0499|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0499|112|S|breathing.||
0499|113|S|   This is not a complete list of possible side effects. If you||
0499|114|S|notice other effects not listed above, contact your doctor or||
0499|115|S|pharmacist.||
0499|116|S|   In the US -||
0499|117|S|   Call your doctor for medical advice about side effects. You||
0499|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0499|119|S|www.fda.gov/medwatch.||
0499|120|S|   In Canada - Call your doctor for medical advice about side||
0499|121|S|effects. You may report side effects to Health Canada at||
0499|122|S|1-866-234-2345.||
0499|123|B|||
0499|124|P|PRECAUTIONS:  Before taking levofloxacin, tell your doctor or||
0499|125|P|pharmacist if you are allergic to it; or to other quinolone||
0499|126|P|antibiotics (such as ciprofloxacin, moxifloxacin, ofloxacin); or||
0499|127|P|if you have any other allergies. This product may contain||
0499|128|P|inactive ingredients, which can cause allergic reactions or other||
0499|129|P|problems. Talk to your pharmacist for more details.||
0499|130|P|   Before using this medication, tell your doctor or pharmacist||
0499|131|P|your medical history, especially of: diabetes, joint/tendon||
0499|132|P|problems (such as tendonitis, bursitis), kidney problems,||
0499|133|P|mental/mood disorders (such as depression), a certain muscle||
0499|134|P|condition (myasthenia gravis), nerve problems (such as peripheral||
0499|135|P|neuropathy), seizure disorder, blood vessel problems (such as||
0499|136|P|aneurysm or blockage of the aorta or other blood vessels,||
0499|137|P|hardening of the arteries), high blood pressure, certain genetic||
0499|138|P|conditions (Marfan syndrome, Ehlers-Danlos syndrome).||
0499|139|P|   Levofloxacin may cause a condition that affects the heart||
0499|140|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0499|141|P|serious (rarely fatal) fast/irregular heartbeat and other||
0499|142|P|symptoms (such as severe dizziness, fainting) that need medical||
0499|143|P|attention right away.||
0499|144|P|   The risk of QT prolongation may be increased if you have||
0499|145|P|certain medical conditions or are taking other drugs that may||
0499|146|P|cause QT prolongation. Before using levofloxacin, tell your||
0499|147|P|doctor or pharmacist of all the drugs you take and if you have||
0499|148|P|any of the following conditions: certain heart problems (heart||
0499|149|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0499|150|P|history of certain heart problems (QT prolongation in the EKG,||
0499|151|P|sudden cardiac death).||
0499|152|P|   Low levels of potassium or magnesium in the blood may also||
0499|153|P|increase your risk of QT prolongation. This risk may increase if||
0499|154|P|you use certain drugs (such as diuretics/"water pills") or if you||
0499|155|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0499|156|P|Talk to your doctor about using levofloxacin safely.||
0499|157|P|   Levofloxacin may rarely cause serious changes in blood sugar,||
0499|158|P|especially if you have diabetes. Watch for symptoms of high blood||
0499|159|P|sugar such as increased thirst/urination. Also watch for symptoms||
0499|160|P|of low blood sugar such as sudden sweating, shaking, fast||
0499|161|P|heartbeat, hunger, blurred vision, dizziness, or tingling||
0499|162|P|hands/feet. It is a good habit to carry glucose tablets or gel to||
0499|163|P|treat low blood sugar. If you don't have these reliable forms of||
0499|164|P|glucose, rapidly raise your blood sugar by eating a quick source||
0499|165|P|of sugar such as table sugar, honey, or candy, or by drinking||
0499|166|P|fruit juice or non-diet soda. Tell your doctor right away about||
0499|167|P|the reaction and the use of this product. To help prevent low||
0499|168|P|blood sugar, eat meals on a regular schedule, and no not skip||
0499|169|P|meals. Your doctor may need to switch you to another antibiotic||
0499|170|P|or adjust your diabetes medications if any reaction occurs.||
0499|171|P|   This drug may make you dizzy or lightheaded. Alcohol or||
0499|172|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
0499|173|P|machinery, or do anything that needs alertness until you can do||
0499|174|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0499|175|P|are using marijuana (cannabis).||
0499|176|P|   This medication may make you more sensitive to the sun. Limit||
0499|177|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0499|178|P|sunscreen and wear protective clothing when outdoors. Tell your||
0499|179|P|doctor right away if you get sunburned or have skin||
0499|180|P|blisters/redness.||
0499|181|P|   Levofloxacin may cause live bacterial vaccines (such as||
0499|182|P|typhoid vaccine) to not work well. Tell your health care||
0499|183|P|professional that you are using levofloxacin before having any||
0499|184|P|immunizations/vaccinations.||
0499|185|P|   Before having surgery, tell your doctor or dentist about all||
0499|186|P|the products you use (including prescription drugs,||
0499|187|P|nonprescription drugs, and herbal products).||
0499|188|P|   Children may be at greater risk for joint/tendon problems||
0499|189|P|while using this drug. Discuss the risks and benefits with the||
0499|190|P|doctor.||
0499|191|P|   Older adults may be at greater risk for tendon problems||
0499|192|P|(especially if they are also taking corticosteroids such as||
0499|193|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
0499|194|P|tear/break in the main blood vessel (aorta).||
0499|195|P|   During pregnancy, this medication should be used only when||
0499|196|P|clearly needed. Discuss the risks and benefits with your doctor.||
0499|197|P|   This drug passes into breast milk. Consult your doctor before||
0499|198|P|breastfeeding.||
0499|199|B|||
0499|200|I|DRUG INTERACTIONS:  See also How to Use section.||
0499|201|I|   Drug interactions may change how your medications work or||
0499|202|I|increase your risk for serious side effects. This document does||
0499|203|I|not contain all possible drug interactions. Keep a list of all||
0499|204|I|the products you use (including prescription/nonprescription||
0499|205|I|drugs and herbal products) and share it with your doctor and||
0499|206|I|pharmacist. Do not start, stop, or change the dosage of any||
0499|207|I|medicines without your doctor's approval.||
0499|208|I|   A product that may interact with this drug is: strontium.||
0499|209|I|   Levofloxacin is very similar to ofloxacin. Do not use||
0499|210|I|medications containing ofloxacin while using levofloxacin.||
0499|211|I|   This medication may interfere with certain lab tests (such as||
0499|212|I|urine screening for opiates), possibly causing false test||
0499|213|I|results. Make sure lab personnel and all your doctors know you||
0499|214|I|use this drug.||
0499|215|B|||
0499|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0499|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0499|218|O|poison control center right away. US residents can call||
0499|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0499|220|O|Symptoms of overdose may include: severe dizziness.||
0499|221|B|||
0499|222|N|NOTES:  Do not share this medication with others.||
0499|223|N|   This medication has been prescribed for your current condition||
0499|224|N|only. Do not use it later for another infection unless your||
0499|225|N|doctor tells you to.||
0499|226|N|   Lab tests (such as kidney function, complete blood count,||
0499|227|N|blood sugar, cultures) may be done before you start taking this||
0499|228|N|medication and while you are taking it. Keep all medical and lab||
0499|229|N|appointments.||
0499|230|B|||
0499|231|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0499|232|D|remember. If it is near the time of the next dose, skip the||
0499|233|D|missed dose. Take your next dose at the regular time. Do not||
0499|234|D|double the dose to catch up.||
0499|235|B|||
0499|236|R|STORAGE:  Store at room temperature. Keep all medications away||
0499|237|R|from children and pets.||
0499|238|R|   Do not flush medications down the toilet or pour them into a||
0499|239|R|drain unless instructed to do so. Properly discard this product||
0499|240|R|when it is expired or no longer needed. Consult your pharmacist||
0499|241|R|or local waste disposal company.||
0499|242|B|||
0499|243|A|Information last revised September 2025.||
0499|244|A|Copyright(c) 2025 First Databank, Inc.||
0499|245|B|||
0500|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0500|002|Z|does NOT have all possible information about this product. This||
0500|003|Z|information does not assure that this product is safe, effective,||
0500|004|Z|or appropriate for you. This information is not individual||
0500|005|Z|medical advice and does not substitute for the advice of your||
0500|006|Z|health care professional. Always ask your health care||
0500|007|Z|professional for complete information about this product and your||
0500|008|Z|specific health needs.||
0500|009|B|||
0500|010|T|ERLOTINIB - ORAL||
0500|011|F|(er-LOE-ti-nib)||
0500|012|B|||
0500|013|C|COMMON BRAND NAME(S): Tarceva||
0500|014|B|||
0500|015|U|USES:  Erlotinib is used to treat lung and pancreatic cancer. It||
0500|016|U|works by slowing or stopping the growth of cancer cells.||
0500|017|B|||
0500|018|H|HOW TO USE:  Take this medication by mouth on an empty stomach||
0500|019|H|(at least 1 hour before or 2 hours after a meal) as directed by||
0500|020|H|your doctor, usually once daily.||
0500|021|H|   The dosage is based on your medical condition, response to||
0500|022|H|treatment, and other medications you may be taking. Be sure to||
0500|023|H|tell your doctor and pharmacist about all the products you use||
0500|024|H|(including prescription drugs, nonprescription drugs, and herbal||
0500|025|H|products).||
0500|026|H|   Medications that reduce stomach acid (such as antacids, proton||
0500|027|H|pump inhibitors/PPIs, H2 blockers) may make erlotinib work less||
0500|028|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
0500|029|H|using this medication. If you take H2 blockers (such as||
0500|030|H|famotidine, nizatidine), take erlotinib at least 2 hours before||
0500|031|H|or 10 hours after taking the H2 blocker. If you take antacids,||
0500|032|H|take erlotinib several hours before or after taking the antacid.||
0500|033|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0500|034|H|using this medication unless your doctor or pharmacist says you||
0500|035|H|may do so safely. Grapefruit can increase the chance of side||
0500|036|H|effects with this medicine. Ask your doctor or pharmacist for||
0500|037|H|more details.||
0500|038|H|   Use this medication regularly to get the most benefit from it.||
0500|039|H|To help you remember, take it at the same time each day.||
0500|040|H|   Do not increase your dose or use this drug more often or for||
0500|041|H|longer than prescribed. Your condition will not improve any||
0500|042|H|faster, and your risk of serious side effects will increase.||
0500|043|H|   Since this drug can be absorbed through the skin and lungs and||
0500|044|H|may harm an unborn baby, women who are pregnant or who may become||
0500|045|H|pregnant should not handle this medication or breathe the dust||
0500|046|H|from the tablets.||
0500|047|B|||
0500|048|S|SIDE EFFECTS:  Diarrhea, dry skin, muscle/joint pain, mouth||
0500|049|S|sores, unusual eyelash growth, or eye dryness/redness/irritation||
0500|050|S|may occur. Diarrhea can be severe. In some cases, your doctor may||
0500|051|S|prescribe medication to relieve diarrhea. If any of these effects||
0500|052|S|last or get worse, tell your doctor or pharmacist promptly.||
0500|053|S|   Remember that this medication has been prescribed because your||
0500|054|S|doctor has judged that the benefit to you is greater than the||
0500|055|S|risk of side effects. Many people using this medication do not||
0500|056|S|have serious side effects.||
0500|057|S|   Tell your doctor right away if you have any serious side||
0500|058|S|effects, including: signs of kidney problems (such as change in||
0500|059|S|the amount of urine), signs of liver disease (such as||
0500|060|S|nausea/vomiting that doesn't stop, loss of appetite,||
0500|061|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
0500|062|S|of dehydration (such as extreme thirst, muscle cramps, dizziness,||
0500|063|S|fainting), redness/swelling around the nails, black stools, vomit||
0500|064|S|that looks like coffee grounds, easy bleeding/bruising, unusual||
0500|065|S|tiredness, eye pain, vision changes.||
0500|066|S|   Get medical help right away if you have any very serious side||
0500|067|S|effects, including: new or worsening shortness of breath or||
0500|068|S|cough, chest/jaw/left arm pain, weakness on one side of the body,||
0500|069|S|trouble speaking, confusion, seizures.||
0500|070|S|   Erlotinib can commonly cause a mild rash that is usually not||
0500|071|S|serious. However, you may not be able to tell it apart from a||
0500|072|S|rare rash that could be a sign of a severe allergic reaction. Get||
0500|073|S|medical help right away if you develop any rash.||
0500|074|S|   A very serious allergic reaction to this drug is rare.||
0500|075|S|However, get medical help right away if you notice any symptoms||
0500|076|S|of a serious allergic reaction, including: rash, itching/swelling||
0500|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0500|078|S|breathing.||
0500|079|S|   This is not a complete list of possible side effects. If you||
0500|080|S|notice other effects not listed above, contact your doctor or||
0500|081|S|pharmacist.||
0500|082|S|   In the US -||
0500|083|S|   Call your doctor for medical advice about side effects. You||
0500|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0500|085|S|www.fda.gov/medwatch.||
0500|086|S|   In Canada - Call your doctor for medical advice about side||
0500|087|S|effects. You may report side effects to Health Canada at||
0500|088|S|1-866-234-2345.||
0500|089|B|||
0500|090|P|PRECAUTIONS:  Before taking erlotinib, tell your doctor or||
0500|091|P|pharmacist if you are allergic to it; or if you have any other||
0500|092|P|allergies. This product may contain inactive ingredients, which||
0500|093|P|can cause allergic reactions or other problems. Talk to your||
0500|094|P|pharmacist for more details.||
0500|095|P|   Before using this medication, tell your doctor or pharmacist||
0500|096|P|your medical history, especially of: liver disease, kidney||
0500|097|P|disease, stomach/intestinal disease (such as ulcers,||
0500|098|P|diverticulosis).||
0500|099|P|   Before having surgery, tell your doctor or dentist about all||
0500|100|P|the products you use (including prescription drugs,||
0500|101|P|nonprescription drugs, and herbal products).||
0500|102|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0500|103|P|while using this medicine may increase your risk for stomach||
0500|104|P|bleeding. Limit alcoholic beverages.||
0500|105|P|   Sunlight may worsen any skin reactions that may occur while||
0500|106|P|you are taking this drug. Limit your time in the sun. Avoid||
0500|107|P|tanning booths and sunlamps. Use sunscreen and wear protective||
0500|108|P|clothing when outdoors.||
0500|109|P|   Since this drug can be absorbed through the skin and lungs and||
0500|110|P|may harm an unborn baby, women who are pregnant or who may become||
0500|111|P|pregnant should not handle this medication or breathe the dust||
0500|112|P|from the tablets.||
0500|113|P|   Tell your doctor if you are pregnant or plan to become||
0500|114|P|pregnant. You should not become pregnant while using erlotinib.||
0500|115|P|Erlotinib may harm an unborn baby. Ask about reliable forms of||
0500|116|P|birth control while using this medication and for 1 month after||
0500|117|P|the last dose. If you become pregnant, talk to your doctor right||
0500|118|P|away about the risks and benefits of this medication.||
0500|119|P|   It is unknown if this drug passes into breast milk. Because of||
0500|120|P|the possible risk to the infant, breastfeeding is not recommended||
0500|121|P|while using this drug and for 2 weeks after the last dose.||
0500|122|P|Consult your doctor before breastfeeding.||
0500|123|B|||
0500|124|I|DRUG INTERACTIONS:  See also How to Use section.||
0500|125|I|   Drug interactions may change how your medications work or||
0500|126|I|increase your risk for serious side effects. This document does||
0500|127|I|not contain all possible drug interactions. Keep a list of all||
0500|128|I|the products you use (including prescription/nonprescription||
0500|129|I|drugs and herbal products) and share it with your doctor and||
0500|130|I|pharmacist. Do not start, stop, or change the dosage of any||
0500|131|I|medicines without your doctor's approval.||
0500|132|I|   Some products that may interact with this drug are: other||
0500|133|I|drugs that can cause bleeding/bruising (including antiplatelet||
0500|134|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
0500|135|I|"blood thinners" such as warfarin/dabigatran).||
0500|136|I|   Aspirin can increase the risk of bleeding when used with this||
0500|137|I|medication. However, if your doctor has told you to take low-dose||
0500|138|I|aspirin to prevent heart attack or stroke (usually 81-162||
0500|139|I|milligrams a day), you should keep taking the aspirin unless your||
0500|140|I|doctor tells you not to. Ask your doctor or pharmacist for more||
0500|141|I|details.||
0500|142|I|   Cigarette smoking decreases blood levels of this medication.||
0500|143|I|Tell your doctor if you smoke or if you have recently stopped||
0500|144|I|smoking.||
0500|145|B|||
0500|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0500|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0500|148|O|poison control center right away. US residents can call||
0500|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0500|150|B|||
0500|151|N|NOTES:  Do not share this medication with others.||
0500|152|N|   Lab and/or medical tests (such as kidney/liver function)||
0500|153|N|should be done while you are taking this medication. Keep all||
0500|154|N|medical and lab appointments. Consult your doctor for more||
0500|155|N|details||
0500|156|B|||
0500|157|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0500|158|D|remember. If it is near the time of the next dose, skip the||
0500|159|D|missed dose. Take your next dose at the regular time. Do not||
0500|160|D|double the dose to catch up.||
0500|161|B|||
0500|162|R|STORAGE:  Store at room temperature away from light and moisture.||
0500|163|R|Do not store in the bathroom. Keep all medications away from||
0500|164|R|children and pets.||
0500|165|R|   Do not flush medications down the toilet or pour them into a||
0500|166|R|drain unless instructed to do so. Properly discard this product||
0500|167|R|when it is expired or no longer needed. Consult your pharmacist||
0500|168|R|or local waste disposal company.||
0500|169|B|||
0500|170|A|Information last revised June 2025.||
0500|171|A|Copyright(c) 2025 First Databank, Inc.||
0500|172|B|||
0502|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0502|002|Z|does NOT have all possible information about this product. This||
0502|003|Z|information does not assure that this product is safe, effective,||
0502|004|Z|or appropriate for you. This information is not individual||
0502|005|Z|medical advice and does not substitute for the advice of your||
0502|006|Z|health care professional. Always ask your health care||
0502|007|Z|professional for complete information about this product and your||
0502|008|Z|specific health needs.||
0502|009|B|||
0502|010|T|IBANDRONATE MONTHLY - ORAL||
0502|011|F|(eye-BAN-droe-nate)||
0502|012|B|||
0502|013|C|COMMON BRAND NAME(S): Boniva||
0502|014|B|||
0502|015|U|USES:  Ibandronate is used to prevent and treat certain types of||
0502|016|U|bone loss (osteoporosis). Osteoporosis causes bones to become||
0502|017|U|thinner and break more easily. Your chance of developing||
0502|018|U|osteoporosis increases after menopause, as you age, or if you||
0502|019|U|take corticosteroid medications (such as prednisone) for long||
0502|020|U|periods.||
0502|021|U|   This medication works by slowing bone loss to help maintain||
0502|022|U|strong bones and reduce the risk of broken bones (fractures).||
0502|023|U|Ibandronate belongs to a class of medications called||
0502|024|U|bisphosphonates.||
0502|025|B|||
0502|026|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0502|027|H|Patient Information Leaflet provided by your pharmacist before||
0502|028|H|you start taking ibandronate and each time you get a refill.||
0502|029|H|Follow the instructions very closely to make sure you absorb as||
0502|030|H|much of the drug as possible and reduce the risk of injury to||
0502|031|H|your esophagus. If you have any questions, ask your doctor or||
0502|032|H|pharmacist.||
0502|033|H|   Take this medication by mouth as directed by your doctor,||
0502|034|H|usually once a month on the same date each month. Choose the day||
0502|035|H|of the month that best fits your schedule. Take this medication||
0502|036|H|after getting up for the day, and at least 60 minutes before||
0502|037|H|taking your first food, beverage or other medication. Do not take||
0502|038|H|it at bedtime or while you are still in bed.||
0502|039|H|   Take this medication with a full glass (6 to 8 ounces/180 to||
0502|040|H|240 milliliters) of plain water. Do not take it with any other||
0502|041|H|beverages. Do not chew or suck the tablet or keep it in your||
0502|042|H|mouth to melt. Swallow the tablet whole. Then stay fully upright||
0502|043|H|(sitting, standing, or walking) for at least 60 minutes and do||
0502|044|H|not lie down until after your first food of the day. Wait at||
0502|045|H|least 60 minutes after taking ibandronate before you eat or drink||
0502|046|H|anything other than plain water and before taking any other||
0502|047|H|medication by mouth.||
0502|048|H|   Medications such as quinapril, sucralfate, and bismuth||
0502|049|H|subsalicylate may interfere with the absorption of ibandronate.||
0502|050|H|Calcium or iron supplements, vitamins with minerals, and antacids||
0502|051|H|containing calcium, magnesium or aluminum, as well as foods such||
0502|052|H|as dairy products (such as milk, yogurt), mineral water, and||
0502|053|H|juice with added calcium, may also interfere with absorption. Do||
0502|054|H|not take these products for at least 60 minutes after taking||
0502|055|H|ibandronate.||
0502|056|H|   Take this medication regularly to get the most benefit from||
0502|057|H|it. To help you remember, take it on the same day each month.||
0502|058|H|Mark your calendar with a reminder. Talk to your doctor about the||
0502|059|H|risks and benefits of long-term use of this medication.||
0502|060|H|   Continue to take other medications for your condition as||
0502|061|H|directed by your doctor.||
0502|062|B|||
0502|063|S|SIDE EFFECTS:  Stomach upset, diarrhea, pain in arms/legs, or||
0502|064|S|mild flu-like symptoms (such as tiredness, muscle ache) may||
0502|065|S|occur. If any of these effects last or get worse, tell your||
0502|066|S|doctor or pharmacist promptly.||
0502|067|S|   Remember that this medication has been prescribed because your||
0502|068|S|doctor has judged that the benefit to you is greater than the||
0502|069|S|risk of side effects. Many people using this medication do not||
0502|070|S|have serious side effects.||
0502|071|S|   Tell your doctor right away if you have any serious side||
0502|072|S|effects, including: increased or severe bone/joint/muscle pain,||
0502|073|S|new or unusual hip/thigh/groin pain, jaw pain, vision changes.||
0502|074|S|   This medication may rarely cause irritation and ulcers in your||
0502|075|S|stomach or esophagus. Get medical help right away if any of these||
0502|076|S|serious side effects occur: new/severe/worsening heartburn, chest||
0502|077|S|pain, difficult or painful swallowing, severe stomach/abdominal||
0502|078|S|pain, black/tarry stools, vomit that looks like coffee grounds.||
0502|079|S|   A very serious allergic reaction to this drug is rare.||
0502|080|S|However, get medical help right away if you notice any symptoms||
0502|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0502|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0502|083|S|breathing.||
0502|084|S|   This is not a complete list of possible side effects. If you||
0502|085|S|notice other effects not listed above, contact your doctor or||
0502|086|S|pharmacist.||
0502|087|S|   In the US -||
0502|088|S|   Call your doctor for medical advice about side effects. You||
0502|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0502|090|S|www.fda.gov/medwatch.||
0502|091|S|   In Canada - Call your doctor for medical advice about side||
0502|092|S|effects. You may report side effects to Health Canada at||
0502|093|S|1-866-234-2345.||
0502|094|B|||
0502|095|P|PRECAUTIONS:  Before taking ibandronate, tell your doctor or||
0502|096|P|pharmacist if you are allergic to it; or to other bisphosphonates||
0502|097|P|(such as alendronate, etidronate, pamidronate, risedronate); or||
0502|098|P|if you have any other allergies. This product may contain||
0502|099|P|inactive ingredients, which can cause allergic reactions or other||
0502|100|P|problems. Talk to your pharmacist for more details.||
0502|101|P|   Before using this medication, tell your doctor or pharmacist||
0502|102|P|your medical history, especially of: esophagus problems (such as||
0502|103|P|heartburn, narrowing of the esophagus, achalasia), low blood||
0502|104|P|calcium levels (hypocalcemia), inability to sit upright or stand||
0502|105|P|for 60 minutes, difficult or painful swallowing,||
0502|106|P|stomach/intestinal disorders (such as ulcers), kidney disease.||
0502|107|P|   Some people taking ibandronate may have serious jawbone||
0502|108|P|problems. Your doctor should check your mouth before you start||
0502|109|P|this medication. Tell your dentist that you are taking this||
0502|110|P|medication before you have any dental work done. To help prevent||
0502|111|P|jawbone problems, have regular dental exams and learn how to keep||
0502|112|P|your teeth and gums healthy. If you have jaw pain, tell your||
0502|113|P|doctor and dentist right away.||
0502|114|P|   Before having surgery (especially dental procedures), tell||
0502|115|P|your doctor and dentist about all the products you use (including||
0502|116|P|prescription drugs, nonprescription drugs, and herbal products).||
0502|117|P|Your doctor or dentist may tell you to stop taking ibandronate||
0502|118|P|before your surgery. Ask for specific instructions about stopping||
0502|119|P|or starting this medication.||
0502|120|P|   Tell your doctor if you are pregnant or plan to become||
0502|121|P|pregnant. Ibandronate may stay in your body for many years. You||
0502|122|P|should not become pregnant while using ibandronate. Discuss the||
0502|123|P|risks and benefits with your doctor.||
0502|124|P|   It is unknown if this drug passes into breast milk. Consult||
0502|125|P|your doctor before breastfeeding.||
0502|126|B|||
0502|127|I|DRUG INTERACTIONS:  See also the How to Use section.||
0502|128|I|   Drug interactions may change how your medications work or||
0502|129|I|increase your risk for serious side effects. This document does||
0502|130|I|not contain all possible drug interactions. Keep a list of all||
0502|131|I|the products you use (including prescription/nonprescription||
0502|132|I|drugs and herbal products) and share it with your doctor and||
0502|133|I|pharmacist. Do not start, stop, or change the dosage of any||
0502|134|I|medicines without your doctor's approval.||
0502|135|I|   This medication may interfere with certain lab tests (such as||
0502|136|I|bone-imaging tests), possibly causing false test results. Make||
0502|137|I|sure lab personnel and all your doctors know you use this drug.||
0502|138|B|||
0502|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0502|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0502|141|O|poison control center right away. US residents can call||
0502|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0502|143|B|||
0502|144|N|NOTES:  Do not share this medication with others.||
0502|145|N|   Lifestyle changes that help promote healthy bones include||
0502|146|N|increasing weight-bearing exercise, stopping smoking, limiting||
0502|147|N|alcohol, and eating well-balanced meals that contain adequate||
0502|148|N|calcium and vitamin D. You may also need to take calcium and||
0502|149|N|vitamin D supplements and make lifestyle changes. Consult your||
0502|150|N|doctor for specific advice.||
0502|151|N|   Lab and/or medical tests (such as bone density tests, x-rays,||
0502|152|N|height, blood mineral levels) should be done while you are taking||
0502|153|N|this medication. Keep all medical and lab appointments. Consult||
0502|154|N|your doctor for more details.||
0502|155|B|||
0502|156|D|MISSED DOSE:  If you miss a dose and your next scheduled dose is||
0502|157|D|more than 7 days away, do not take the medication later in the||
0502|158|D|day. Take it the next morning after you remember. Then keep||
0502|159|D|taking your monthly dose in the morning on your originally chosen||
0502|160|D|day of the month. If your next scheduled dose is only 1 to 7 days||
0502|161|D|away, wait until your selected day to take the medication. Do not||
0502|162|D|take two tablets within the same week to catch up. Consult your||
0502|163|D|doctor or pharmacist if you have any questions.||
0502|164|B|||
0502|165|R|STORAGE:  Store at room temperature away from light and moisture.||
0502|166|R|Do not store in the bathroom. Keep all medications away from||
0502|167|R|children and pets.||
0502|168|R|   Do not flush medications down the toilet or pour them into a||
0502|169|R|drain unless instructed to do so. Properly discard this product||
0502|170|R|when it is expired or no longer needed. Consult your pharmacist||
0502|171|R|or local waste disposal company.||
0502|172|B|||
0502|173|A|Information last revised September 2025.||
0502|174|A|Copyright(c) 2025 First Databank, Inc.||
0502|175|B|||
0503|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0503|002|Z|does NOT have all possible information about this product. This||
0503|003|Z|information does not assure that this product is safe, effective,||
0503|004|Z|or appropriate for you. This information is not individual||
0503|005|Z|medical advice and does not substitute for the advice of your||
0503|006|Z|health care professional. Always ask your health care||
0503|007|Z|professional for complete information about this product and your||
0503|008|Z|specific health needs.||
0503|009|B|||
0503|010|T|CHORIOGONADOTROPIN ALFA PREFILLED SYRINGE/PEN - INJECTION||
0503|011|F|(KOR-ee-o-goe-nad-oh-troe-pin AL-fa)||
0503|012|B|||
0503|013|C|COMMON BRAND NAME(S): Ovidrel||
0503|014|B|||
0503|015|U|USES:  This medication is used as part of a treatment program for||
0503|016|U|certain fertility problems in women. It is generally used in||
0503|017|U|combination with another hormone (FSH). This medication provides||
0503|018|U|the hormone (hCG), which stimulates the release of a mature egg||
0503|019|U|(ovulation) and helps you become pregnant.||
0503|020|U|   This medication is not recommended for women whose ovaries no||
0503|021|U|longer make eggs properly (primary ovarian failure).||
0503|022|U|   This medication has not been shown to be effective for weight||
0503|023|U|loss and should not be used for this purpose due to risk of||
0503|024|U|serious side effects.||
0503|025|B|||
0503|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0503|027|H|from your pharmacist before you start using this medication and||
0503|028|H|each time you get a refill. Ask your health care professional how||
0503|029|H|to prepare and use this medication. If you have any questions,||
0503|030|H|ask your doctor or pharmacist.||
0503|031|H|   Inject this medication under the skin as directed by your||
0503|032|H|doctor, usually one day after your last dose of the hormone FSH.||
0503|033|H|The injection is given in the abdomen. Follow your doctor's||
0503|034|H|instruction closely to ensure proper timing of this medication.||
0503|035|H|    Before using, check this product for particles or||
0503|036|H|discoloration. If either is present, do not use the liquid.||
0503|037|H|Before injecting each dose, clean the injection site with rubbing||
0503|038|H|alcohol. To lessen bruising, do not rub the injection site after||
0503|039|H|a shot. Learn how to store and discard medical supplies safely.||
0503|040|B|||
0503|041|S|SIDE EFFECTS:  Redness or pain at the injection site, mild||
0503|042|S|abdominal pain, mood changes, or mild nausea/vomiting may occur.||
0503|043|S|If any of these effects last or get worse, tell your doctor or||
0503|044|S|pharmacist promptly.||
0503|045|S|   Remember that this medication has been prescribed because your||
0503|046|S|doctor has judged that the benefit to you is greater than the||
0503|047|S|risk of side effects. Many people using this medication do not||
0503|048|S|have serious side effects.||
0503|049|S|   Tell your doctor right away if you have any serious side||
0503|050|S|effects, including: unusual vaginal bleeding.||
0503|051|S|   Get medical help right away if you have any very serious side||
0503|052|S|effects, including: weakness on one side of the body, trouble||
0503|053|S|speaking, vision changes, sudden/severe headache, pain/swelling||
0503|054|S|of the calf muscles, chest pain, shortness of breath, swelling of||
0503|055|S|ankles/hands/feet.||
0503|056|S|   This medication may cause a condition known as ovarian||
0503|057|S|hyperstimulation syndrome (OHSS). This condition may occur during||
0503|058|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
0503|059|S|build up in the stomach, chest, and heart area. Get medical help||
0503|060|S|right away if you develop the following side effects: severe pain||
0503|061|S|or swelling in the lower abdominal (pelvic) area, severe||
0503|062|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
0503|063|S|urination.||
0503|064|S|   A very serious allergic reaction to this drug is rare.||
0503|065|S|However, get medical help right away if you notice any symptoms||
0503|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0503|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0503|068|S|breathing.||
0503|069|S|   This is not a complete list of possible side effects. If you||
0503|070|S|notice other effects not listed above, contact your doctor or||
0503|071|S|pharmacist.||
0503|072|S|   In the US -||
0503|073|S|   Call your doctor for medical advice about side effects. You||
0503|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0503|075|S|www.fda.gov/medwatch.||
0503|076|S|   In Canada - Call your doctor for medical advice about side||
0503|077|S|effects. You may report side effects to Health Canada at||
0503|078|S|1-866-234-2345.||
0503|079|B|||
0503|080|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0503|081|P|pharmacist if you are allergic to it; or to other products||
0503|082|P|containing chorionic gonadotropin (hCG); or if you have any other||
0503|083|P|allergies. This product may contain inactive ingredients, which||
0503|084|P|can cause allergic reactions or other problems. Talk to your||
0503|085|P|pharmacist for more details.||
0503|086|P|   Before using this medication, tell your doctor or pharmacist||
0503|087|P|your medical history, especially of: other fertility problems||
0503|088|P|(such as primary ovarian failure), thyroid or adrenal gland||
0503|089|P|problems, cancer of the reproductive organs (such as breast,||
0503|090|P|uterus, ovary), tumor in the brain (such as pituitary tumor),||
0503|091|P|abnormal uterine/vaginal bleeding, unexplained ovarian cysts or||
0503|092|P|enlarged ovaries, blood clots, stroke, certain heart diseases||
0503|093|P|(such as heart attacks), liver disease, lung problems (such as||
0503|094|P|asthma).||
0503|095|P|   Multiple births may occur because of this treatment. Consult||
0503|096|P|your doctor for more details.||
0503|097|P|   Stop using this medication when you become pregnant. This||
0503|098|P|medication must not be used during pregnancy. If you think you||
0503|099|P|may be pregnant, tell your doctor right away.||
0503|100|P|   It is unknown if this drug passes into breast milk. Consult||
0503|101|P|your doctor before breastfeeding.||
0503|102|B|||
0503|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0503|104|I|medications work or increase your risk for serious side effects.||
0503|105|I|This document does not contain all possible drug interactions.||
0503|106|I|Keep a list of all the products you use (including||
0503|107|I|prescription/nonprescription drugs and herbal products) and share||
0503|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
0503|109|I|the dosage of any medicines without your doctor's approval.||
0503|110|I|   A product that may interact with this drug is: gonadorelin.||
0503|111|I|   This medication may interfere with certain lab tests (such as||
0503|112|I|gonadotropin levels), possibly causing false test results. Make||
0503|113|I|sure lab personnel and all your doctors know you use this drug.||
0503|114|B|||
0503|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0503|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0503|117|O|poison control center right away. US residents can call||
0503|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0503|119|B|||
0503|120|N|NOTES:  Do not share this medication with others.||
0503|121|N|   Lab and/or medical tests (such as blood hormone tests such as||
0503|122|N|estradiol levels, vaginal ultrasound) should be done while you||
0503|123|N|are using this medication. Keep all medical and lab appointments.||
0503|124|N|Consult your doctor for more details.||
0503|125|B|||
0503|126|D|MISSED DOSE:  It is important to use this medication at the||
0503|127|D|scheduled time. If you miss a dose and forget to use your||
0503|128|D|medication, contact your doctor or pharmacist right away for||
0503|129|D|instructions. Do not double the dose to catch up.||
0503|130|B|||
0503|131|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
0503|132|R|medication in the original carton to protect from light. The||
0503|133|R|prefilled syringe may also be stored at room temperature if||
0503|134|R|needed. If the medication is stored at room temperature, discard||
0503|135|R|after 30 days. Keep all medications away from children and pets.||
0503|136|R|   Do not flush medications down the toilet or pour them into a||
0503|137|R|drain unless instructed to do so. Properly discard this product||
0503|138|R|when it is expired or no longer needed. Consult your pharmacist||
0503|139|R|or local waste disposal company.||
0503|140|B|||
0503|141|A|Information last revised August 2024.||
0503|142|A|Copyright(c) 2025 First Databank, Inc.||
0503|143|B|||
0504|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0504|002|Z|does NOT have all possible information about this product. This||
0504|003|Z|information does not assure that this product is safe, effective,||
0504|004|Z|or appropriate for you. This information is not individual||
0504|005|Z|medical advice and does not substitute for the advice of your||
0504|006|Z|health care professional. Always ask your health care||
0504|007|Z|professional for complete information about this product and your||
0504|008|Z|specific health needs.||
0504|009|B|||
0504|010|T|ENTECAVIR - ORAL||
0504|011|F|(en-TEK-a-vir)||
0504|012|B|||
0504|013|C|COMMON BRAND NAME(S): Baraclude||
0504|014|B|||
0504|015|W|WARNING:  Rarely, entecavir may cause serious (possibly fatal)||
0504|016|W|liver problems and lactic acid build-up in the blood (lactic||
0504|017|W|acidosis). Get medical help right away if you have any of the||
0504|018|W|following symptoms: nausea/vomiting that doesn't stop, loss of||
0504|019|W|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0504|020|W|urine, unusual tiredness/weakness, deep/fast breathing, unusual||
0504|021|W|drowsiness, unusual muscle pain, feeling cold in your arms/legs,||
0504|022|W|fast/irregular heartbeat. These side effects may occur more often||
0504|023|W|in women and obese patients.||
0504|024|W|   Your hepatitis B infection may get worse if you stop taking||
0504|025|W|entecavir. Do not stop this medication without talking to your||
0504|026|W|doctor. Your doctor will do blood tests to check your liver for||
0504|027|W|several months after you stop entecavir.||
0504|028|W|   This medication is not recommended if you have both HIV and||
0504|029|W|hepatitis B and are not receiving effective treatment for HIV.||
0504|030|W|This drug does not treat HIV, and it can cause certain HIV||
0504|031|W|medications to become ineffective. Get an HIV test before||
0504|032|W|starting this medication, and get tested again anytime you may||
0504|033|W|have become infected. Consult your doctor for more details.||
0504|034|B|||
0504|035|U|USES:  See also Warning section.||
0504|036|U|   Entecavir is used to treat long-term hepatitis B infection.||
0504|037|U|Hepatitis B is an infection of the liver caused by the hepatitis||
0504|038|U|B virus. Long-term infection can cause liver damage, rarely liver||
0504|039|U|cancer, and liver failure. Entecavir helps to decrease the amount||
0504|040|U|of hepatitis B virus in your body. It is unknown if this||
0504|041|U|medication lowers your chance of getting liver cancer or liver||
0504|042|U|damage. Entecavir is an antiviral that belongs to a class of||
0504|043|U|drugs known as hepatitis B virus nucleoside reverse transcriptase||
0504|044|U|inhibitors.||
0504|045|U|   Entecavir is not a cure for hepatitis B. It does not prevent||
0504|046|U|the spread of the virus to others through sexual contact or||
0504|047|U|blood/body fluid contamination (such as sharing used needles).||
0504|048|B|||
0504|049|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0504|050|H|from your pharmacist before you start taking entecavir and each||
0504|051|H|time you get a refill. If you have any questions, ask your doctor||
0504|052|H|or pharmacist.||
0504|053|H|   Take this medication by mouth on an empty stomach (at least 2||
0504|054|H|hours after a meal and 2 hours before the next meal) as directed||
0504|055|H|by your doctor, usually once daily.||
0504|056|H|   If you are taking entecavir oral liquid, carefully measure||
0504|057|H|your dose with the medicine spoon provided. Do not use a||
0504|058|H|household spoon because you may not get the correct dose. Swallow||
0504|059|H|the medicine directly from the measuring spoon. Do not mix the||
0504|060|H|medication with water or other liquids. Rinse the spoon with||
0504|061|H|water after each use.||
0504|062|H|   The dosage is based on your medical condition and response to||
0504|063|H|treatment. Children's dosage is also based on weight.||
0504|064|H|   It is very important to keep taking this medication exactly as||
0504|065|H|prescribed by your doctor. Do not skip any doses.||
0504|066|H|   This medication works best when the amount of drug in your||
0504|067|H|body is kept at a constant level. Take this drug at evenly spaced||
0504|068|H|intervals. To help you remember, take it at the same time each||
0504|069|H|day.||
0504|070|H|   Do not take more or less of this drug than prescribed or stop||
0504|071|H|taking it even for a short time unless directed to do so by your||
0504|072|H|doctor. Doing so may cause the amount of virus to increase, make||
0504|073|H|the infection more difficult to treat (resistant), or worsen side||
0504|074|H|effects. See also Warning section.||
0504|075|H|   Tell your doctor if your condition does not get better or if||
0504|076|H|it gets worse.||
0504|077|B|||
0504|078|S|SIDE EFFECTS:  See also Warning section.||
0504|079|S|   Headache, tiredness, dizziness, or nausea may occur. If any of||
0504|080|S|these effects last or get worse, tell your doctor or pharmacist||
0504|081|S|promptly.||
0504|082|S|   Remember that this medication has been prescribed because your||
0504|083|S|doctor has judged that the benefit to you is greater than the||
0504|084|S|risk of side effects. Many people using this medication do not||
0504|085|S|have serious side effects.||
0504|086|S|   A very serious allergic reaction to this drug is rare.||
0504|087|S|However, get medical help right away if you notice any symptoms||
0504|088|S|of a serious allergic reaction, including: rash, itching/swelling||
0504|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0504|090|S|breathing.||
0504|091|S|   This is not a complete list of possible side effects. If you||
0504|092|S|notice other effects not listed above, contact your doctor or||
0504|093|S|pharmacist.||
0504|094|S|   In the US -||
0504|095|S|   Call your doctor for medical advice about side effects. You||
0504|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0504|097|S|www.fda.gov/medwatch.||
0504|098|S|   In Canada - Call your doctor for medical advice about side||
0504|099|S|effects. You may report side effects to Health Canada at||
0504|100|S|1-866-234-2345.||
0504|101|B|||
0504|102|P|PRECAUTIONS:  Before taking entecavir, tell your doctor or||
0504|103|P|pharmacist if you are allergic to it; or if you have any other||
0504|104|P|allergies. This product may contain inactive ingredients, which||
0504|105|P|can cause allergic reactions or other problems. Talk to your||
0504|106|P|pharmacist for more details.||
0504|107|P|   Before using this medication, tell your doctor or pharmacist||
0504|108|P|your medical history, especially of: HIV infection, kidney||
0504|109|P|disease, other hepatitis B drugs taken in the past.||
0504|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0504|111|P|can make you more dizzy. Do not drive, use machinery, or do||
0504|112|P|anything that needs alertness until you can do it safely. Avoid||
0504|113|P|alcoholic beverages. Alcohol may also worsen liver problems. Talk||
0504|114|P|to your doctor if you are using marijuana (cannabis).||
0504|115|P|   Before having surgery, tell your doctor or dentist about all||
0504|116|P|the products you use (including prescription drugs,||
0504|117|P|nonprescription drugs, and herbal products).||
0504|118|P|   To decrease your risk of spreading hepatitis B to others,||
0504|119|P|always use an effective barrier method (latex or polyurethane||
0504|120|P|condoms/dental dams) during all sexual activity. Consult your||
0504|121|P|doctor or pharmacist for more details.||
0504|122|P|   During pregnancy, this medication should be used only when||
0504|123|P|clearly needed. It is not known if this medication helps to||
0504|124|P|prevent the hepatitis B virus from passing from the mother to the||
0504|125|P|baby. Discuss the risks and benefits with your doctor.||
0504|126|P|   It is unknown if this medication passes into breast milk. If||
0504|127|P|you have HIV, breast milk may transmit HIV. Consult your doctor||
0504|128|P|before breastfeeding.||
0504|129|B|||
0504|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0504|131|I|medications work or increase your risk for serious side effects.||
0504|132|I|This document does not contain all possible drug interactions.||
0504|133|I|Keep a list of all the products you use (including||
0504|134|I|prescription/nonprescription drugs and herbal products) and share||
0504|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
0504|136|I|the dosage of any medicines without your doctor's approval.||
0504|137|B|||
0504|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0504|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0504|140|O|poison control center right away. US residents can call||
0504|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0504|142|B|||
0504|143|N|NOTES:  Do not share this medication with others.||
0504|144|N|   Lab and/or medical tests (such as liver tests, virus levels)||
0504|145|N|should be done while you are taking this medication. Keep all||
0504|146|N|medical and lab appointments.||
0504|147|B|||
0504|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0504|149|D|remember. If it is near the time of the next dose, skip the||
0504|150|D|missed dose. Take your next dose at the regular time. Do not||
0504|151|D|double the dose to catch up.||
0504|152|B|||
0504|153|R|STORAGE:  Store at room temperature away from light and moisture.||
0504|154|R|Keep the bottle of medication in the original carton to protect||
0504|155|R|from light. Do not store in the bathroom. Keep all medications||
0504|156|R|away from children and pets.||
0504|157|R|   Do not flush medications down the toilet or pour them into a||
0504|158|R|drain unless instructed to do so. Properly discard this product||
0504|159|R|when it is expired or no longer needed. Consult your pharmacist||
0504|160|R|or local waste disposal company.||
0504|161|B|||
0504|162|A|Information last revised August 2024.||
0504|163|A|Copyright(c) 2025 First Databank, Inc.||
0504|164|B|||
0506|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0506|002|Z|does NOT have all possible information about this product. This||
0506|003|Z|information does not assure that this product is safe, effective,||
0506|004|Z|or appropriate for you. This information is not individual||
0506|005|Z|medical advice and does not substitute for the advice of your||
0506|006|Z|health care professional. Always ask your health care||
0506|007|Z|professional for complete information about this product and your||
0506|008|Z|specific health needs.||
0506|009|B|||
0506|010|T|DEXMETHYLPHENIDATE EXTENDED-RELEASE CAPSULE - ORAL||
0506|011|F|(dex-METH-il-FEN-i-date)||
0506|012|B|||
0506|013|C|COMMON BRAND NAME(S): Focalin XR||
0506|014|B|||
0506|015|W|WARNING:  Misuse or abuse of dexmethylphenidate may result in||
0506|016|W|serious (possibly fatal) heart and blood pressure problems.||
0506|017|W|   This medication can be habit-forming and should be used||
0506|018|W|cautiously by people who have mental/mood disorders or a||
0506|019|W|substance use disorder (such as overuse of or addiction to||
0506|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
0506|021|W|you have a personal or family history of a substance use||
0506|022|W|disorder. Do not increase your dose, use it more often, or use it||
0506|023|W|for a longer time or in a different way than prescribed. Doing so||
0506|024|W|may result in a decrease in the effect of this drug, drug||
0506|025|W|dependence, or abnormal thoughts/behavior.||
0506|026|W|   Your doctor may monitor you for a while after the medication||
0506|027|W|is stopped, especially if you have taken this drug for a long||
0506|028|W|time or in high doses. (See also How to Use section.)||
0506|029|B|||
0506|030|U|USES:  This medication is used to treat attention deficit||
0506|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
0506|032|U|of certain natural substances in the brain. Dexmethylphenidate||
0506|033|U|belongs to a class of drugs known as stimulants. It can help||
0506|034|U|increase your ability to pay attention, stay focused on an||
0506|035|U|activity, and control behavior problems. It may also help you to||
0506|036|U|organize your tasks and improve listening skills.||
0506|037|B|||
0506|038|V|OTHER USES:  This section contains uses of this drug that are not||
0506|039|V|listed in the approved professional labeling for the drug but||
0506|040|V|that may be prescribed by your health care professional. Use this||
0506|041|V|drug for a condition that is listed in this section only if it||
0506|042|V|has been so prescribed by your health care professional.||
0506|043|V|   This drug may also be used for a certain sleep disorder||
0506|044|V|(narcolepsy).||
0506|045|B|||
0506|046|H|HOW TO USE:  Read the Medication Guide provided by your||
0506|047|H|pharmacist before you start taking dexmethylphenidate and each||
0506|048|H|time you get a refill. If you have any questions, ask your doctor||
0506|049|H|or pharmacist.||
0506|050|H|   Take this medication by mouth as directed by your doctor,||
0506|051|H|usually once daily in the morning, with or without food. Taking||
0506|052|H|this medication late in the day may cause trouble sleeping||
0506|053|H|(insomnia).||
0506|054|H|   The dosage is based on your medical condition and response to||
0506|055|H|treatment. Your doctor may direct you to gradually increase or||
0506|056|H|decrease your dose. Also, if you have used it for a long time, do||
0506|057|H|not suddenly stop using this drug without consulting your doctor.||
0506|058|H|   Do not break, crush, or chew this medication. Doing so can||
0506|059|H|release all of the drug at once, increasing the risk of side||
0506|060|H|effects. Swallow the capsules whole. If you have trouble||
0506|061|H|swallowing the capsule, you may open the capsule and carefully||
0506|062|H|sprinkle its contents on a spoonful of cool applesauce. Swallow||
0506|063|H|all of the mixture right away without chewing it. Then drink a||
0506|064|H|glass of cool liquid to make sure you have swallowed all of the||
0506|065|H|dose. Do not prepare the mixture ahead of time.||
0506|066|H|   Methylphenidate and dexmethylphenidate are different||
0506|067|H|medications and do not provide the same amount of medicine. Do||
0506|068|H|not switch between products unless your doctor tells you to.||
0506|069|H|   Take this medication regularly to get the most benefit from||
0506|070|H|it. To help you remember, take it at the same time each day.||
0506|071|H|   If you suddenly stop using this medication, you may have||
0506|072|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
0506|073|H|other mental/mood changes). To help prevent withdrawal, your||
0506|074|H|doctor may lower your dose slowly. Withdrawal is more likely if||
0506|075|H|you have used dexmethylphenidate for a long time or in high||
0506|076|H|doses. Tell your doctor or pharmacist right away if you have||
0506|077|H|withdrawal.||
0506|078|H|   When this medication is used for a long time, it may not work||
0506|079|H|as well. Talk with your doctor if this medication stops working||
0506|080|H|well.||
0506|081|H|   Though it helps many people, this medication may sometimes||
0506|082|H|cause addiction. This risk may be higher if you have a substance||
0506|083|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0506|084|H|Take this medication exactly as prescribed to lower the risk of||
0506|085|H|addiction. Ask your doctor or pharmacist for more details.||
0506|086|H|   Tell your doctor if your condition does not get better or if||
0506|087|H|it gets worse.||
0506|088|B|||
0506|089|S|SIDE EFFECTS:  Trouble sleeping, nervousness, dizziness, dry||
0506|090|S|mouth, heartburn, nausea, stomach pain, headache, loss of||
0506|091|S|appetite, or weight loss may occur. If any of these effects last||
0506|092|S|or get worse, tell your doctor or pharmacist promptly.||
0506|093|S|   Remember that this medication has been prescribed because your||
0506|094|S|doctor has judged that the benefit to you is greater than the||
0506|095|S|risk of side effects. Many people using this medication do not||
0506|096|S|have serious side effects.||
0506|097|S|   This medication may raise your blood pressure. Check your||
0506|098|S|blood pressure regularly and tell your doctor if the results are||
0506|099|S|high.||
0506|100|S|   Tell your doctor right away if you have any serious side||
0506|101|S|effects, including: signs of blood flow problems in the fingers||
0506|102|S|or toes (such as coldness, numbness, pain, or skin color||
0506|103|S|changes), unusual wounds on the fingers or toes,||
0506|104|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
0506|105|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
0506|106|S|thoughts of suicide), uncontrolled muscle movements (such as||
0506|107|S|twitching, shaking), sudden outbursts of words/sounds that are||
0506|108|S|hard to control, vision changes (such as blurred vision).||
0506|109|S|   Get medical help right away if you have any very serious side||
0506|110|S|effects, including: fainting, seizure, symptoms of a heart attack||
0506|111|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
0506|112|S|sweating), symptoms of a stroke (such as weakness on one side of||
0506|113|S|the body, trouble speaking, sudden vision changes, confusion).||
0506|114|S|   Rarely, males (including young boys and teens) may have a||
0506|115|S|painful or prolonged erection lasting 4 or more hours while using||
0506|116|S|this medication. Caregivers/parents should also be watchful for||
0506|117|S|this serious side effect in boys. If a painful or prolonged||
0506|118|S|erection occurs, stop using this drug and get medical help right||
0506|119|S|away, or permanent problems could occur. Ask your doctor or||
0506|120|S|pharmacist for more details.||
0506|121|S|   A very serious allergic reaction to this drug is rare.||
0506|122|S|However, get medical help right away if you notice any symptoms||
0506|123|S|of a serious allergic reaction, including: rash, itching/swelling||
0506|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0506|125|S|breathing.||
0506|126|S|   This is not a complete list of possible side effects. If you||
0506|127|S|notice other effects not listed above, contact your doctor or||
0506|128|S|pharmacist.||
0506|129|S|   In the US -||
0506|130|S|   Call your doctor for medical advice about side effects. You||
0506|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0506|132|S|www.fda.gov/medwatch.||
0506|133|S|   In Canada - Call your doctor for medical advice about side||
0506|134|S|effects. You may report side effects to Health Canada at||
0506|135|S|1-866-234-2345.||
0506|136|B|||
0506|137|P|PRECAUTIONS:  See also Warning section.||
0506|138|P|   Before taking dexmethylphenidate, tell your doctor or||
0506|139|P|pharmacist if you are allergic to it; or to methylphenidate; or||
0506|140|P|if you have any other allergies. This product may contain||
0506|141|P|inactive ingredients, which can cause allergic reactions or other||
0506|142|P|problems. Talk to your pharmacist for more details.||
0506|143|P|   Before using this medication, tell your doctor or pharmacist||
0506|144|P|your medical history, especially of: high blood pressure, blood||
0506|145|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
0506|146|P|problems (such as irregular heartbeat, heart failure, previous||
0506|147|P|heart attack, problems with heart structure), family history of||
0506|148|P|heart problems (such as sudden cardiac death, irregular||
0506|149|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
0506|150|P|agitation), personal/family history of mental/mood disorders||
0506|151|P|(such as bipolar disorder, depression, psychosis, suicidal||
0506|152|P|thoughts), personal/family history of uncontrolled muscle||
0506|153|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
0506|154|P|(hyperthyroidism), seizure disorder.||
0506|155|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0506|156|P|can make you more dizzy. Do not drive, use machinery, or do||
0506|157|P|anything that needs alertness until you can do it safely. Limit||
0506|158|P|alcoholic beverages. Talk to your doctor if you are using||
0506|159|P|marijuana (cannabis).||
0506|160|P|   Before having surgery, tell your doctor or dentist about all||
0506|161|P|the products you use (including prescription drugs,||
0506|162|P|nonprescription drugs, and herbal products).||
0506|163|P|   Children (especially those younger than 6) may be more||
0506|164|P|sensitive to the side effects of this drug, especially weight||
0506|165|P|loss. If used for a long time, this drug may affect a child's||
0506|166|P|growth rate, weight, and final adult height. To reduce the risk,||
0506|167|P|the doctor may recommend briefly stopping the medication from||
0506|168|P|time to time. Check the child's weight and height regularly, and||
0506|169|P|consult your doctor or pharmacist for more details.||
0506|170|P|   Older adults may be more sensitive to the side effects of this||
0506|171|P|drug, especially trouble sleeping, weight loss, or chest pain.||
0506|172|P|   During pregnancy, this medication should be used only when||
0506|173|P|clearly needed. Discuss the risks and benefits with your doctor.||
0506|174|P|   This drug passes into breast milk. Consult your doctor before||
0506|175|P|breastfeeding.||
0506|176|B|||
0506|177|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0506|178|I|medications work or increase your risk for serious side effects.||
0506|179|I|This document does not contain all possible drug interactions.||
0506|180|I|Keep a list of all the products you use (including||
0506|181|I|prescription/nonprescription drugs and herbal products) and share||
0506|182|I|it with your doctor and pharmacist. Do not start, stop, or change||
0506|183|I|the dosage of any medicines without your doctor's approval.||
0506|184|I|   Taking MAO inhibitors with this medication may cause a serious||
0506|185|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0506|186|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0506|187|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0506|188|I|selegiline, tranylcypromine) during treatment with this||
0506|189|I|medication. Most MAO inhibitors should also not be taken for two||
0506|190|I|weeks before treatment with this medication. Ask your doctor when||
0506|191|I|to start or stop taking this medication.||
0506|192|I|   Dexmethylphenidate is very similar to methylphenidate. Do not||
0506|193|I|use medications containing methylphenidate while using||
0506|194|I|dexmethylphenidate.||
0506|195|I|   This medication may interfere with certain medical/lab tests||
0506|196|I|(such as brain scan for Parkinson's disease), possibly causing||
0506|197|I|false test results. Make sure lab personnel and all your doctors||
0506|198|I|know you use this drug.||
0506|199|B|||
0506|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0506|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0506|202|O|poison control center right away. US residents can call||
0506|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0506|204|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
0506|205|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
0506|206|O|loss of consciousness.||
0506|207|B|||
0506|208|N|NOTES:  Do not share this medication with others. Sharing it is||
0506|209|N|against the law.||
0506|210|N|   Lab and/or medical tests (such as blood pressure, complete||
0506|211|N|blood count, height/weight monitoring in children) may be done||
0506|212|N|while you are taking this medication. Keep all medical and lab||
0506|213|N|appointments. Consult your doctor for more details.||
0506|214|B|||
0506|215|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0506|216|D|remember. If it is near bedtime or near the time of the next||
0506|217|D|dose, skip the missed dose. Take your next dose at the regular||
0506|218|D|time. Do not double the dose to catch up.||
0506|219|B|||
0506|220|R|STORAGE:  Store at room temperature away from light and moisture.||
0506|221|R|Do not store in the bathroom. Keep all medications away from||
0506|222|R|children and pets.||
0506|223|R|   Do not flush medications down the toilet or pour them into a||
0506|224|R|drain unless instructed to do so. Properly discard this product||
0506|225|R|when it is expired or no longer needed. Consult your pharmacist||
0506|226|R|or local waste disposal company.||
0506|227|B|||
0506|228|A|Information last revised July 2025.||
0506|229|A|Copyright(c) 2025 First Databank, Inc.||
0506|230|B|||
0507|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0507|002|Z|does NOT have all possible information about this product. This||
0507|003|Z|information does not assure that this product is safe, effective,||
0507|004|Z|or appropriate for you. This information is not individual||
0507|005|Z|medical advice and does not substitute for the advice of your||
0507|006|Z|health care professional. Always ask your health care||
0507|007|Z|professional for complete information about this product and your||
0507|008|Z|specific health needs.||
0507|009|B|||
0507|010|T|TIMOLOL SOLUTION - OPHTHALMIC||
0507|011|F|(TIE-moh-lohl)||
0507|012|B|||
0507|013|C|COMMON BRAND NAME(S): Timoptic||
0507|014|B|||
0507|015|U|USES:  This medication is used to treat high pressure inside the||
0507|016|U|eye due to glaucoma (open angle-type) or other eye diseases (such||
0507|017|U|as ocular hypertension). Lowering high pressure inside the eye||
0507|018|U|helps to prevent blindness. This medication works by decreasing||
0507|019|U|the amount of fluid within the eye. Timolol belongs to a class of||
0507|020|U|drugs known as beta-blockers.||
0507|021|B|||
0507|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0507|023|H|from your pharmacist before you start using timolol and each time||
0507|024|H|you get a refill. If you have any questions, ask your doctor or||
0507|025|H|pharmacist.||
0507|026|H|   Use this medication in the affected eye(s) as directed by your||
0507|027|H|doctor, usually once in the morning or twice daily.||
0507|028|H|   To apply eye drops, wash your hands first. To avoid||
0507|029|H|contamination, do not touch the dropper tip or let it touch your||
0507|030|H|eye or any other surface.||
0507|031|H|   If you are wearing contact lenses, remove them before using||
0507|032|H|eye drops. Wait at least 15 minutes before replacing your contact||
0507|033|H|lenses.||
0507|034|H|   Tilt your head back, look upward, and pull down the lower||
0507|035|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0507|036|H|and place one drop into the pouch. Look downward, gently close||
0507|037|H|your eyes, and place one finger at the corner of your eye (near||
0507|038|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
0507|039|H|opening your eyes. This will prevent the medication from draining||
0507|040|H|out. Try not to blink or rub your eye. If directed to use this||
0507|041|H|medication in both eyes, repeat these steps for your other eye.||
0507|042|H|   Do not rinse the dropper. Replace the dropper cap after each||
0507|043|H|use.||
0507|044|H|   If you are using another kind of eye medication (such as drops||
0507|045|H|or ointments), wait at least 10 minutes before applying other||
0507|046|H|medications. Use eye drops before eye ointments to allow the eye||
0507|047|H|drops to enter the eye.||
0507|048|H|   Wait several minutes for your vision to clear before driving||
0507|049|H|or operating machinery.||
0507|050|H|   Use this medication regularly in order to get the most benefit||
0507|051|H|from it. To help you remember, use it at the same time(s) each||
0507|052|H|day. Keep using this medication even if you feel well. Most||
0507|053|H|people with glaucoma or high pressure in the eyes do not feel||
0507|054|H|sick.||
0507|055|B|||
0507|056|S|SIDE EFFECTS:  Temporary blurred vision, temporary||
0507|057|S|burning/stinging/itching/redness of the eye, watery eyes, dry||
0507|058|S|eyes, feeling as if something is in the eye, or headache may||
0507|059|S|occur. If any of these effects last or get worse, notify your||
0507|060|S|doctor or pharmacist promptly.||
0507|061|S|   Remember that this medication has been prescribed because your||
0507|062|S|doctor has judged that the benefit to you is greater than the||
0507|063|S|risk of side effects. Many people using this medication do not||
0507|064|S|have serious side effects.||
0507|065|S|   Tell your doctor right away if you have any serious side||
0507|066|S|effects, including: dizziness, eye pain/swelling/discharge,||
0507|067|S|slow/irregular heartbeat, muscle weakness, mental/mood changes,||
0507|068|S|coldness/numbness/pain in the hands or feet, vision changes,||
0507|069|S|unusual tiredness/weakness.||
0507|070|S|   Get medical help right away if you have any very serious side||
0507|071|S|effects, including: dizziness that doesn't stop, trouble||
0507|072|S|breathing, sudden unexplained weight gain, chest pain, weakness||
0507|073|S|on one side of the body, trouble speaking, confusion, fainting.||
0507|074|S|   A very serious allergic reaction to this drug is rare.||
0507|075|S|However, get medical help right away if you notice any symptoms||
0507|076|S|of a serious allergic reaction, including: rash, itching/swelling||
0507|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0507|078|S|breathing.||
0507|079|S|   This is not a complete list of possible side effects. If you||
0507|080|S|notice other effects not listed above, contact your doctor or||
0507|081|S|pharmacist.||
0507|082|S|   In the US -||
0507|083|S|   Call your doctor for medical advice about side effects. You||
0507|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0507|085|S|www.fda.gov/medwatch.||
0507|086|S|   In Canada - Call your doctor for medical advice about side||
0507|087|S|effects. You may report side effects to Health Canada at||
0507|088|S|1-866-234-2345.||
0507|089|B|||
0507|090|P|PRECAUTIONS:  Before using timolol, tell your doctor or||
0507|091|P|pharmacist if you are allergic to it; or if you have any other||
0507|092|P|allergies. This product may contain inactive ingredients (such as||
0507|093|P|preservatives like benzalkonium chloride), which can cause||
0507|094|P|allergic reactions or other problems. Talk to your pharmacist for||
0507|095|P|more details.||
0507|096|P|   Before using this medication, tell your doctor or pharmacist||
0507|097|P|your medical history, especially of: lung disease (such as||
0507|098|P|current or past history of asthma, severe chronic obstructive||
0507|099|P|pulmonary disease), certain types of irregular heartbeats (such||
0507|100|P|as sinus bradycardia, second or third degree AV block), certain||
0507|101|P|types of heart disease (such as severe heart failure, cardiogenic||
0507|102|P|shock), kidney disease, liver disease, diabetes, low blood flow||
0507|103|P|to the brain (cerebrovascular insufficiency), overactive thyroid||
0507|104|P|disease, muscle weakness disorders, severe allergies.||
0507|105|P|   If you develop an eye infection or injury, or have eye||
0507|106|P|surgery, check with your doctor about whether you should continue||
0507|107|P|to use your current bottle of timolol. You may be advised to||
0507|108|P|start using a new bottle.||
0507|109|P|   Before having surgery, tell your doctor or dentist about all||
0507|110|P|the products you use (including prescription drugs,||
0507|111|P|nonprescription drugs, and herbal products).||
0507|112|P|   This product may prevent the fast/pounding heartbeat you would||
0507|113|P|usually feel when your blood sugar level falls too low||
0507|114|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0507|115|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0507|116|P|blood sugar level, such as dizziness and sweating, are not||
0507|117|P|affected by this drug.||
0507|118|P|   If you have diabetes, this product may make it harder to||
0507|119|P|control your blood sugar levels. Check your blood sugar levels||
0507|120|P|regularly as directed by your doctor. Tell your doctor right away||
0507|121|P|if you have symptoms of high blood sugar such as increased||
0507|122|P|thirst/urination. Your doctor may need to adjust your diabetes||
0507|123|P|medication, exercise program, or diet.||
0507|124|P|   After you apply this drug, your vision may become temporarily||
0507|125|P|blurred. Do not drive, use machinery, or do anything that needs||
0507|126|P|clear vision until you can do it safely.||
0507|127|P|   During pregnancy, this medication should be used only when||
0507|128|P|clearly needed. Discuss the risks and benefits with your doctor.||
0507|129|P|   This drug passes into breast milk. Consult your doctor before||
0507|130|P|breastfeeding.||
0507|131|B|||
0507|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0507|133|I|medications work or increase your risk for serious side effects.||
0507|134|I|This document does not contain all possible drug interactions.||
0507|135|I|Keep a list of all the products you use (including||
0507|136|I|prescription/nonprescription drugs and herbal products) and share||
0507|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
0507|138|I|the dosage of any medicines without your doctor's approval.||
0507|139|I|   Some products that may interact with this drug include: oral||
0507|140|I|beta-blockers (such as propranolol), clonidine, certain||
0507|141|I|antidepressants (including SSRIs such as fluoxetine), digoxin,||
0507|142|I|epinephrine, methyldopa, quinidine.||
0507|143|B|||
0507|144|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0507|145|O|has overdosed and has serious symptoms such as passing out or||
0507|146|O|trouble breathing, call 911. Otherwise, call a poison control||
0507|147|O|center right away. US residents can call 1-800-222-1222. Canada||
0507|148|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0507|149|O|include: trouble breathing or slow/irregular heartbeat.||
0507|150|B|||
0507|151|N|NOTES:  Do not share this medication with others.||
0507|152|N|   Lab and/or medical tests (such as eye exams) should be done||
0507|153|N|while you are using this medication. Keep all medical and lab||
0507|154|N|appointments. Consult your doctor for more details.||
0507|155|B|||
0507|156|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0507|157|D|If it is near the time of the next dose, skip the missed dose.||
0507|158|D|Use your next dose at the regular time. Do not double the dose to||
0507|159|D|catch up.||
0507|160|B|||
0507|161|R|STORAGE:  Store at room temperature away from light and moisture.||
0507|162|R|Avoid freezing. Keep all medications away from children and pets.||
0507|163|R|   This product is normally a colorless to light yellow solution.||
0507|164|R|Discard the solution if it changes color, becomes cloudy, or||
0507|165|R|develops particles.||
0507|166|R|   Do not flush medications down the toilet or pour them into a||
0507|167|R|drain unless instructed to do so. Properly discard this product||
0507|168|R|when it is expired or no longer needed. Consult your pharmacist||
0507|169|R|or local waste disposal company.||
0507|170|B|||
0507|171|A|Information last revised May 2024.||
0507|172|A|Copyright(c) 2025 First Databank, Inc.||
0507|173|B|||
0508|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0508|002|Z|does NOT have all possible information about this product. This||
0508|003|Z|information does not assure that this product is safe, effective,||
0508|004|Z|or appropriate for you. This information is not individual||
0508|005|Z|medical advice and does not substitute for the advice of your||
0508|006|Z|health care professional. Always ask your health care||
0508|007|Z|professional for complete information about this product and your||
0508|008|Z|specific health needs.||
0508|009|B|||
0508|010|T|TIMOLOL SOLUTION PRESERVATIVE-FREE - OPHTHALMIC||
0508|011|F|(TIE-moh-lohl)||
0508|012|B|||
0508|013|C|COMMON BRAND NAME(S): Timoptic||
0508|014|B|||
0508|015|U|USES:  This medication is used to treat high pressure inside the||
0508|016|U|eye due to glaucoma (open angle-type) or other eye diseases (such||
0508|017|U|as ocular hypertension). Lowering high pressure inside the eye||
0508|018|U|helps to prevent blindness. This medication works by decreasing||
0508|019|U|the amount of fluid within the eye. Timolol belongs to a class of||
0508|020|U|drugs known as beta-blockers.||
0508|021|B|||
0508|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0508|023|H|directed by your doctor, usually once or twice a day.||
0508|024|H|   To apply eye drops, wash your hands first. To avoid||
0508|025|H|contamination, do not touch the dropper tip or let it touch your||
0508|026|H|eye or any other surface.||
0508|027|H|   If you wear contact lenses, remove them before using the eye||
0508|028|H|drops. Wait at least 15 minutes after using this medication||
0508|029|H|before putting in your contact lenses.||
0508|030|H|   This product does not contain a preservative. Do not open the||
0508|031|H|single-use container until just before you are ready to use it.||
0508|032|H|After use, throw away the remaining contents of the container||
0508|033|H|right away.||
0508|034|H|   Tilt your head back, look upward and pull down the lower||
0508|035|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0508|036|H|and place one drop in your eye. Look downward and gently close||
0508|037|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0508|038|H|your eye (near the nose) and apply gentle pressure. Try not to||
0508|039|H|blink and do not rub your eye. This will prevent the medication||
0508|040|H|from draining out. Repeat these steps for your other eye if so||
0508|041|H|directed.||
0508|042|H|   If you are using another kind of eye medication (such as drops||
0508|043|H|or ointments), wait at least 10 minutes before applying other||
0508|044|H|medications. Use eye drops before eye ointments to allow the eye||
0508|045|H|drops to enter the eye.||
0508|046|H|   Wait several minutes for your vision to clear before driving||
0508|047|H|or operating machinery.||
0508|048|H|   Use this medication regularly in order to get the most benefit||
0508|049|H|from it. To help you remember, use it at the same time(s) each||
0508|050|H|day. Keep using this medication even if you feel well. Most||
0508|051|H|people with glaucoma or high pressure in the eyes do not feel||
0508|052|H|sick.||
0508|053|B|||
0508|054|S|SIDE EFFECTS:  Temporary blurred vision, temporary||
0508|055|S|burning/stinging/itching/redness of the eye, watery eyes, dry||
0508|056|S|eyes, feeling as if something is in the eye, or headache may||
0508|057|S|occur. If any of these effects last or get worse, notify your||
0508|058|S|doctor or pharmacist promptly.||
0508|059|S|   Remember that this medication has been prescribed because your||
0508|060|S|doctor has judged that the benefit to you is greater than the||
0508|061|S|risk of side effects. Many people using this medication do not||
0508|062|S|have serious side effects.||
0508|063|S|   Tell your doctor right away if you have any serious side||
0508|064|S|effects, including: dizziness, eye pain/swelling/discharge,||
0508|065|S|slow/irregular heartbeat, muscle weakness, mental/mood changes,||
0508|066|S|coldness/numbness/pain in the hands or feet, vision changes,||
0508|067|S|unusual tiredness/weakness.||
0508|068|S|   Get medical help right away if you have any very serious side||
0508|069|S|effects, including: dizziness that doesn't stop, trouble||
0508|070|S|breathing, sudden unexplained weight gain, chest pain, weakness||
0508|071|S|on one side of the body, trouble speaking, confusion, fainting.||
0508|072|S|   A very serious allergic reaction to this drug is rare.||
0508|073|S|However, get medical help right away if you notice any symptoms||
0508|074|S|of a serious allergic reaction, including: rash, itching/swelling||
0508|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0508|076|S|breathing.||
0508|077|S|   This is not a complete list of possible side effects. If you||
0508|078|S|notice other effects not listed above, contact your doctor or||
0508|079|S|pharmacist.||
0508|080|S|   In the US -||
0508|081|S|   Call your doctor for medical advice about side effects. You||
0508|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0508|083|S|www.fda.gov/medwatch.||
0508|084|S|   In Canada - Call your doctor for medical advice about side||
0508|085|S|effects. You may report side effects to Health Canada at||
0508|086|S|1-866-234-2345.||
0508|087|B|||
0508|088|P|PRECAUTIONS:  Before using timolol, tell your doctor or||
0508|089|P|pharmacist if you are allergic to it; or if you have any other||
0508|090|P|allergies. This product may contain inactive ingredients, which||
0508|091|P|can cause allergic reactions or other problems. Talk to your||
0508|092|P|pharmacist for more details.||
0508|093|P|   Before using this medication, tell your doctor or pharmacist||
0508|094|P|your medical history, especially of: lung disease (such as||
0508|095|P|current or past history of asthma, severe chronic obstructive||
0508|096|P|pulmonary disease), certain types of irregular heartbeats (such||
0508|097|P|as sinus bradycardia, second or third degree AV block), certain||
0508|098|P|types of heart disease (such as severe heart failure), kidney||
0508|099|P|disease, liver disease, diabetes, low blood flow to the brain||
0508|100|P|(cerebrovascular insufficiency), overactive thyroid disease,||
0508|101|P|muscle weakness disorders, severe allergies.||
0508|102|P|   Before having surgery, tell your doctor or dentist about all||
0508|103|P|the products you use (including prescription drugs,||
0508|104|P|nonprescription drugs, and herbal products).||
0508|105|P|   This product may prevent the fast/pounding heartbeat you would||
0508|106|P|usually feel when your blood sugar level falls too low||
0508|107|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0508|108|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0508|109|P|blood sugar level, such as dizziness and sweating, are not||
0508|110|P|affected by this drug.||
0508|111|P|   If you have diabetes, this product may make it harder to||
0508|112|P|control your blood sugar levels. Check your blood sugar levels||
0508|113|P|regularly as directed by your doctor. Tell your doctor right away||
0508|114|P|if you have symptoms of high blood sugar such as increased||
0508|115|P|thirst/urination. Your doctor may need to adjust your diabetes||
0508|116|P|medication, exercise program, or diet.||
0508|117|P|   After you apply this drug, your vision may become temporarily||
0508|118|P|blurred. Do not drive, use machinery, or do anything that needs||
0508|119|P|clear vision until you can do it safely.||
0508|120|P|   During pregnancy, this medication should be used only when||
0508|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
0508|122|P|   This drug passes into breast milk. Consult your doctor before||
0508|123|P|breastfeeding.||
0508|124|B|||
0508|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0508|126|I|medications work or increase your risk for serious side effects.||
0508|127|I|This document does not contain all possible drug interactions.||
0508|128|I|Keep a list of all the products you use (including||
0508|129|I|prescription/nonprescription drugs and herbal products) and share||
0508|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
0508|131|I|the dosage of any medicines without your doctor's approval.||
0508|132|I|   Some products that may interact with this drug include: oral||
0508|133|I|beta-blockers (such as propranolol), clonidine, certain||
0508|134|I|antidepressants (including SSRIs such as fluoxetine), digoxin,||
0508|135|I|epinephrine, methyldopa, quinidine.||
0508|136|B|||
0508|137|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0508|138|O|has overdosed and has serious symptoms such as passing out or||
0508|139|O|trouble breathing, call 911. Otherwise, call a poison control||
0508|140|O|center right away. US residents can call 1-800-222-1222. Canada||
0508|141|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0508|142|O|include: trouble breathing or slow/irregular heartbeat.||
0508|143|B|||
0508|144|N|NOTES:  Do not share this medication with others.||
0508|145|N|   Lab and/or medical tests (such as eye exams) should be done||
0508|146|N|while you are using this medication. Keep all medical and lab||
0508|147|N|appointments. Consult your doctor for more details.||
0508|148|B|||
0508|149|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0508|150|D|If it is near the time of the next dose, skip the missed dose.||
0508|151|D|Use your next dose at the regular time. Do not double the dose to||
0508|152|D|catch up.||
0508|153|B|||
0508|154|R|STORAGE:  Store at room temperature. Do not freeze. Keep the||
0508|155|R|medication in the original foil pouch to protect from light and||
0508|156|R|evaporation. Once the foil pouch is opened, this medication||
0508|157|R|expires after one month. Keep all medications away from children||
0508|158|R|and pets.||
0508|159|R|   This product is normally a colorless to light yellow solution.||
0508|160|R|Discard the solution if it changes color, becomes cloudy, or||
0508|161|R|develops particles.||
0508|162|R|   Do not flush medications down the toilet or pour them into a||
0508|163|R|drain unless instructed to do so. Properly discard this product||
0508|164|R|when it is expired or no longer needed. Consult your pharmacist||
0508|165|R|or local waste disposal company.||
0508|166|B|||
0508|167|A|Information last revised July 2024.||
0508|168|A|Copyright(c) 2025 First Databank, Inc.||
0508|169|B|||
0509|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0509|002|Z|does NOT have all possible information about this product. This||
0509|003|Z|information does not assure that this product is safe, effective,||
0509|004|Z|or appropriate for you. This information is not individual||
0509|005|Z|medical advice and does not substitute for the advice of your||
0509|006|Z|health care professional. Always ask your health care||
0509|007|Z|professional for complete information about this product and your||
0509|008|Z|specific health needs.||
0509|009|B|||
0509|010|T|TIGECYCLINE - INJECTION||
0509|011|F|(TYE-ge-SYE-kleen)||
0509|012|B|||
0509|013|C|COMMON BRAND NAME(S): Tygacil||
0509|014|B|||
0509|015|W|WARNING:  This medication may increase the risk of death. It||
0509|016|W|should only be used when other treatments have not worked.||
0509|017|W|Discuss the risks and benefits of this medication, as well as||
0509|018|W|other effective and possibly safer treatments for your infection,||
0509|019|W|with your doctor.||
0509|020|B|||
0509|021|U|USES:  Tigecycline is used to treat certain serious bacterial||
0509|022|U|infections when other antibiotics may not work. It is related to||
0509|023|U|a class of drugs known as tetracycline antibiotics. It works by||
0509|024|U|stopping the growth of bacteria.||
0509|025|B|||
0509|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0509|027|H|from your pharmacist before you start using tigecycline and each||
0509|028|H|time you get a refill. If you have any questions, ask your doctor||
0509|029|H|or pharmacist.||
0509|030|H|   This medication is given by injection into a vein over 30 to||
0509|031|H|60 minutes by a healthcare professional. It is given as directed||
0509|032|H|by your doctor, usually every 12 hours. The dosage is based on||
0509|033|H|your medical condition and response to treatment.||
0509|034|H|   If you are using this medication at home, learn all||
0509|035|H|preparation and usage instructions from your health care||
0509|036|H|professional. Swirl the medication gently to mix. Do not shake.||
0509|037|H|The mixed medication should be yellow to orange in color. Before||
0509|038|H|using, check this product for particles or discoloration. If||
0509|039|H|either is present, do not use the liquid. Learn how to store and||
0509|040|H|discard medical supplies safely.||
0509|041|H|   For the best effect, use this antibiotic at evenly spaced||
0509|042|H|times. To help you remember, use this medication at the same||
0509|043|H|times every day.||
0509|044|H|   Continue to use this medication until the full prescribed||
0509|045|H|amount is finished, even if symptoms disappear after a few days.||
0509|046|H|Stopping the medication too early may result in a return of the||
0509|047|H|infection.||
0509|048|H|   Tell your doctor if your condition lasts or gets worse.||
0509|049|B|||
0509|050|S|SIDE EFFECTS:  Nausea, vomiting, headache, dizziness, or||
0509|051|S|pain/swelling at the injection site may occur. If any of these||
0509|052|S|effects last or get worse, tell your doctor or pharmacist||
0509|053|S|promptly.||
0509|054|S|   Remember that this medication has been prescribed because your||
0509|055|S|doctor has judged that the benefit to you is greater than the||
0509|056|S|risk of side effects. Many people using this medication do not||
0509|057|S|have serious side effects.||
0509|058|S|   Tell your doctor right away if you have any serious side||
0509|059|S|effects, including: signs of kidney problems (such as change in||
0509|060|S|the amount of urine), unusual tiredness, hearing changes (such as||
0509|061|S|ringing in the ears, decreased hearing), irregular heartbeat,||
0509|062|S|easy bleeding/bruising, signs of liver disease (such as yellowing||
0509|063|S|eyes/skin, dark urine, stomach/abdominal pain).||
0509|064|S|   Tetracycline drugs such as tigecycline may rarely cause||
0509|065|S|increased pressure around the brain (intracranial||
0509|066|S|hypertension-IH). The risk of this side effect is greater for||
0509|067|S|women of childbearing age who are overweight or who have had IH||
0509|068|S|in the past. If IH develops, it usually goes away after||
0509|069|S|tigecycline is stopped; however, there is a chance of permanent||
0509|070|S|vision loss or blindness. Get medical help right away if you||
0509|071|S|have: headaches that are severe or don't go away, nausea/vomiting||
0509|072|S|that doesn't stop, vision changes (such as blurred/double vision,||
0509|073|S|decreased vision, sudden blindness).||
0509|074|S|   This medication may rarely cause a severe intestinal condition||
0509|075|S|due to a bacteria called C. difficile. This condition may occur||
0509|076|S|during treatment or weeks to months after treatment has stopped.||
0509|077|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0509|078|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0509|079|S|stool.||
0509|080|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0509|081|S|products because they may make symptoms worse.||
0509|082|S|   Use of this medication for prolonged or repeated periods may||
0509|083|S|result in oral thrush or a new yeast infection. Contact your||
0509|084|S|doctor if you notice white patches in your mouth, a change in||
0509|085|S|vaginal discharge, or other new symptoms.||
0509|086|S|   A very serious allergic reaction to this drug is rare.||
0509|087|S|However, get medical help right away if you notice any symptoms||
0509|088|S|of a serious allergic reaction, including: rash, itching/swelling||
0509|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0509|090|S|breathing.||
0509|091|S|   This is not a complete list of possible side effects. If you||
0509|092|S|notice other effects not listed above, contact your doctor or||
0509|093|S|pharmacist.||
0509|094|S|   In the US -||
0509|095|S|   Call your doctor for medical advice about side effects. You||
0509|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0509|097|S|www.fda.gov/medwatch.||
0509|098|S|   In Canada - Call your doctor for medical advice about side||
0509|099|S|effects. You may report side effects to Health Canada at||
0509|100|S|1-866-234-2345.||
0509|101|B|||
0509|102|P|PRECAUTIONS:  See also Side Effects section.||
0509|103|P|   Before using tigecycline, tell your doctor or pharmacist if||
0509|104|P|you are allergic to it; or to tetracyclines (such as doxycycline,||
0509|105|P|minocycline, tetracycline); or if you have any other allergies.||
0509|106|P|This product may contain inactive ingredients, which can cause||
0509|107|P|allergic reactions or other problems. Talk to your pharmacist for||
0509|108|P|more details.||
0509|109|P|   Before using this medication, tell your doctor or pharmacist||
0509|110|P|your medical history, especially of: liver disease.||
0509|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0509|112|P|can make you more dizzy. Do not drive, use machinery, or do||
0509|113|P|anything that needs alertness until you can do it safely. Limit||
0509|114|P|alcoholic beverages. Talk to your doctor if you are using||
0509|115|P|marijuana (cannabis).||
0509|116|P|   Tigecycline may cause live bacterial vaccines (such as typhoid||
0509|117|P|vaccine) to not work well. Tell your health care professional||
0509|118|P|that you are using tigecycline before having any||
0509|119|P|immunizations/vaccinations.||
0509|120|P|   This medication may make you more sensitive to the sun. Limit||
0509|121|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0509|122|P|sunscreen and wear protective clothing when outdoors. Tell your||
0509|123|P|doctor right away if you get sunburned or have skin||
0509|124|P|blisters/redness.||
0509|125|P|   Before having surgery, tell your doctor or dentist about all||
0509|126|P|the products you use (including prescription drugs,||
0509|127|P|nonprescription drugs, and herbal products).||
0509|128|P|   Children younger than 8 years may be more sensitive to the||
0509|129|P|side effects of tigecycline, especially tooth discoloration.||
0509|130|P|Tooth discoloration has also occurred in older children and in||
0509|131|P|young adults. Discuss the risks and benefits of this medication||
0509|132|P|with the doctor.||
0509|133|P|   Tell your doctor if you are pregnant or plan to become||
0509|134|P|pregnant. You should not become pregnant while using tigecycline.||
0509|135|P|Tigecycline may harm an unborn baby. If you become pregnant, talk||
0509|136|P|to your doctor right away about the risks and benefits of this||
0509|137|P|medication.||
0509|138|P|   It is unknown if this medication passes into breast milk.||
0509|139|P|Consult your doctor before breastfeeding.||
0509|140|B|||
0509|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0509|142|I|medications work or increase your risk for serious side effects.||
0509|143|I|This document does not contain all possible drug interactions.||
0509|144|I|Keep a list of all the products you use (including||
0509|145|I|prescription/nonprescription drugs and herbal products) and share||
0509|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
0509|147|I|the dosage of any medicines without your doctor's approval.||
0509|148|I|   Some products that may interact with this drug are: retinoid||
0509|149|I|medications taken by mouth (such as acitretin, isotretinoin).||
0509|150|B|||
0509|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0509|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0509|153|O|poison control center right away. US residents can call||
0509|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0509|155|B|||
0509|156|N|NOTES:  Lab and/or medical tests (such as liver function,||
0509|157|N|fibrinogen levels, blood counts, cultures) may be done while you||
0509|158|N|are using this medication. Keep all medical and lab appointments.||
0509|159|N|Consult your doctor for more details.||
0509|160|B|||
0509|161|D|MISSED DOSE:  It is important to get each dose of this medication||
0509|162|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0509|163|D|right away for a new dosing schedule.||
0509|164|B|||
0509|165|R|STORAGE:  Consult the product instructions and your pharmacist||
0509|166|R|for storage details. Keep all medications away from children and||
0509|167|R|pets.||
0509|168|R|   Do not flush medications down the toilet or pour them into a||
0509|169|R|drain unless instructed to do so. Properly discard this product||
0509|170|R|when it is expired or no longer needed. Consult your pharmacist||
0509|171|R|or local waste disposal company.||
0509|172|B|||
0509|173|A|Information last revised December 2024.||
0509|174|A|Copyright(c) 2025 First Databank, Inc.||
0509|175|B|||
0510|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0510|002|Z|does NOT have all possible information about this product. This||
0510|003|Z|information does not assure that this product is safe, effective,||
0510|004|Z|or appropriate for you. This information is not individual||
0510|005|Z|medical advice and does not substitute for the advice of your||
0510|006|Z|health care professional. Always ask your health care||
0510|007|Z|professional for complete information about this product and your||
0510|008|Z|specific health needs.||
0510|009|B|||
0510|010|T|ALPRAZOLAM DISINTEGRATING TABLET - ORAL||
0510|011|F|(al-PRA-zoe-lam)||
0510|012|B|||
0510|013|C|COMMON BRAND NAME(S): Niravam||
0510|014|B|||
0510|015|W|WARNING:  Alprazolam has a risk for abuse and addiction, which||
0510|016|W|can lead to overdose and death. Taking this medication with||
0510|017|W|alcohol or other drugs that can cause drowsiness or breathing||
0510|018|W|problems (especially opioid medications such as codeine,||
0510|019|W|hydrocodone) may cause very serious side effects, including||
0510|020|W|death. To lower your risk, your doctor should have you take the||
0510|021|W|smallest dose of alprazolam that works, and take it for the||
0510|022|W|shortest possible time. Be sure you know how to take alprazolam||
0510|023|W|and what other drugs you should avoid taking with it. See also||
0510|024|W|Drug Interactions section. Get medical help right away if any of||
0510|025|W|these very serious side effects occur: slow/shallow breathing,||
0510|026|W|unusual lightheadedness, severe drowsiness/dizziness, difficulty||
0510|027|W|waking up.||
0510|028|W|   Suddenly stopping this medication may cause serious (possibly||
0510|029|W|fatal) withdrawal, especially if you have used it for a long time||
0510|030|W|or in high doses. To prevent withdrawal, your doctor may lower||
0510|031|W|your dose slowly. Tell your doctor or pharmacist right away if||
0510|032|W|you have any withdrawal symptoms such as headaches, trouble||
0510|033|W|sleeping, restlessness, hallucinations/confusion, depression,||
0510|034|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
0510|035|W|to months.||
0510|036|B|||
0510|037|U|USES:  This medication is used to treat certain anxiety and panic||
0510|038|U|disorders. Alprazolam belongs to a class of medications called||
0510|039|U|benzodiazepines. It acts on the brain and nerves to produce a||
0510|040|U|calming effect and helps relieve panic and anxiety symptoms. It||
0510|041|U|works by enhancing the effects of a certain natural chemical in||
0510|042|U|the body (GABA).||
0510|043|B|||
0510|044|H|HOW TO USE:  See also Warning section.||
0510|045|H|   Read the Medication Guide provided by your pharmacist before||
0510|046|H|you start taking alprazolam and each time you get a refill. If||
0510|047|H|you have any questions, ask your doctor or pharmacist.||
0510|048|H|   Take this medication by mouth as directed by your doctor. The||
0510|049|H|dosage is based on your medical condition, age, and response to||
0510|050|H|treatment. Your dose may be gradually increased until the drug||
0510|051|H|starts working well. Follow your doctor's instructions closely to||
0510|052|H|reduce the risk of side effects.||
0510|053|H|   It is best not to take this medication with a high-fat meal||
0510|054|H|because absorption may be slowed.||
0510|055|H|   Make sure your hands are dry before you are ready to take this||
0510|056|H|medication. Place the tablet on top of your tongue immediately||
0510|057|H|after removing it from the bottle. The tablet will dissolve in||
0510|058|H|your mouth. Although it is not necessary to take this medication||
0510|059|H|with any liquid, you may take it with water.||
0510|060|H|   If your dose is only half a tablet, be sure to throw away the||
0510|061|H|unused portion of the tablet. Do not save it for future use||
0510|062|H|because it may become inactive.||
0510|063|H|   Though it helps many people, this medication may sometimes||
0510|064|H|cause addiction. This risk may be higher if you have a substance||
0510|065|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0510|066|H|Take this medication exactly as prescribed to lower the risk of||
0510|067|H|addiction. Ask your doctor or pharmacist for more details.||
0510|068|H|   When this medication is used for a long time, it may not work||
0510|069|H|as well. Talk with your doctor if this medication stops working||
0510|070|H|well.||
0510|071|H|   Tell your doctor if your condition lasts or gets worse.||
0510|072|B|||
0510|073|S|SIDE EFFECTS:  See also Warning section.||
0510|074|S|   Drowsiness, dizziness, increased saliva production, or change||
0510|075|S|in sex drive/ability may occur. If any of these effects last or||
0510|076|S|get worse, tell your doctor or pharmacist promptly.||
0510|077|S|   To reduce the risk of dizziness and lightheadedness, get up||
0510|078|S|slowly when rising from a sitting or lying position.||
0510|079|S|   Remember that this medication has been prescribed because your||
0510|080|S|doctor has judged that the benefit to you is greater than the||
0510|081|S|risk of side effects. Many people using this medication do not||
0510|082|S|have serious side effects.||
0510|083|S|   Tell your doctor right away if you have any serious side||
0510|084|S|effects, including: mental/mood changes (such as hallucinations,||
0510|085|S|thoughts of suicide), trouble speaking, loss of coordination,||
0510|086|S|trouble walking, memory problems.||
0510|087|S|   Get medical help right away if you have any very serious side||
0510|088|S|effects, including: yellowing eyes/skin, seizures.||
0510|089|S|   A very serious allergic reaction to this drug is rare.||
0510|090|S|However, get medical help right away if you notice any symptoms||
0510|091|S|of a serious allergic reaction, including: rash, itching/swelling||
0510|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0510|093|S|breathing.||
0510|094|S|   This is not a complete list of possible side effects. If you||
0510|095|S|notice other effects not listed above, contact your doctor or||
0510|096|S|pharmacist.||
0510|097|S|   In the US -||
0510|098|S|   Call your doctor for medical advice about side effects. You||
0510|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0510|100|S|www.fda.gov/medwatch.||
0510|101|S|   In Canada - Call your doctor for medical advice about side||
0510|102|S|effects. You may report side effects to Health Canada at||
0510|103|S|1-866-234-2345.||
0510|104|B|||
0510|105|P|PRECAUTIONS:  Before taking alprazolam, tell your doctor or||
0510|106|P|pharmacist if you are allergic to it; or to other benzodiazepines||
0510|107|P|(such as diazepam, lorazepam); or if you have any other||
0510|108|P|allergies. This product may contain inactive ingredients, which||
0510|109|P|can cause allergic reactions or other problems. Talk to your||
0510|110|P|pharmacist for more details.||
0510|111|P|   Before using this medication, tell your doctor or pharmacist||
0510|112|P|your medical history, especially of: lung/breathing problems||
0510|113|P|(such as COPD, sleep apnea), liver disease, kidney disease,||
0510|114|P|personal or family history of a substance use disorder (such as||
0510|115|P|overuse of or addiction to drugs/alcohol), glaucoma.||
0510|116|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0510|117|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0510|118|P|machinery, or do anything that needs alertness until you can do||
0510|119|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0510|120|P|are using marijuana (cannabis).||
0510|121|P|   Before having surgery, tell your doctor or dentist about all||
0510|122|P|the products you use (including prescription drugs,||
0510|123|P|nonprescription drugs, and herbal products).||
0510|124|P|   Older adults may be more sensitive to the side effects of this||
0510|125|P|drug, especially loss of coordination and drowsiness. These side||
0510|126|P|effects can increase the risk of falling.||
0510|127|P|   Tell your doctor if you are pregnant or plan to become||
0510|128|P|pregnant. You should not become pregnant while using alprazolam.||
0510|129|P|Alprazolam may harm an unborn baby. Newborn babies of mothers who||
0510|130|P|use this medication late in pregnancy may have symptoms such as||
0510|131|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
0510|132|P|feeding. If you become pregnant, talk to your doctor right away||
0510|133|P|about the risks and benefits of this medication.||
0510|134|P|   This drug passes into breast milk and may have undesirable||
0510|135|P|effects on a nursing infant. Breastfeeding is not recommended||
0510|136|P|while using this drug. Consult your doctor before breastfeeding.||
0510|137|B|||
0510|138|I|DRUG INTERACTIONS:  See also Warning section.||
0510|139|I|   Drug interactions may change how your medications work or||
0510|140|I|increase your risk for serious side effects. This document does||
0510|141|I|not contain all possible drug interactions. Keep a list of all||
0510|142|I|the products you use (including prescription/nonprescription||
0510|143|I|drugs and herbal products) and share it with your doctor and||
0510|144|I|pharmacist. Do not start, stop, or change the dosage of any||
0510|145|I|medicines without your doctor's approval.||
0510|146|I|   Some products that may interact with this drug include: kava,||
0510|147|I|sodium oxybate, drugs that affect stomach acid (such as antacids,||
0510|148|I|famotidine, omeprazole).||
0510|149|I|   Other medications can affect the removal of alprazolam from||
0510|150|I|your body, which may affect how alprazolam works. Examples||
0510|151|I|include adagrasib, azole antifungals (such as itraconazole,||
0510|152|I|ketoconazole), cimetidine, certain anti-depressants (such as||
0510|153|I|fluoxetine, fluvoxamine, nefazodone), macrolide antibiotics (such||
0510|154|I|as erythromycin), rifamycins (such as rifabutin), St. John's||
0510|155|I|wort, drugs used to treat seizures (such as phenytoin), among||
0510|156|I|others.||
0510|157|I|   The risk of serious side effects (such as slow/shallow||
0510|158|I|breathing, severe drowsiness/dizziness) may be increased if this||
0510|159|I|medication is taken with other products that may also cause||
0510|160|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0510|161|I|if you are taking other products such as opioid pain or cough||
0510|162|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0510|163|I|(cannabis), other drugs for sleep or anxiety (such as diazepam,||
0510|164|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0510|165|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0510|166|I|diphenhydramine).||
0510|167|I|   Check the labels on all your medicines (such as allergy or||
0510|168|I|cough-and-cold products) because they may contain ingredients||
0510|169|I|that cause drowsiness. Ask your pharmacist about using those||
0510|170|I|products safely.||
0510|171|I|   Cigarette smoking decreases blood levels of this medication.||
0510|172|I|Tell your doctor if you smoke or if you have recently stopped||
0510|173|I|smoking.||
0510|174|B|||
0510|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0510|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0510|177|O|poison control center right away. US residents can call||
0510|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0510|179|O|Symptoms of overdose may include: severe drowsiness,||
0510|180|O|slowed/reduced reflexes, slowed breathing, loss of consciousness.||
0510|181|B|||
0510|182|N|NOTES:  Do not share this medication with others. Sharing it is||
0510|183|N|against the law.||
0510|184|N|   Lab and/or medical tests (such as liver function) should be||
0510|185|N|done while you are taking this medication. Keep all medical and||
0510|186|N|lab appointments. Consult your doctor for more details.||
0510|187|B|||
0510|188|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0510|189|D|remember. If it is near the time of the next dose, skip the||
0510|190|D|missed dose. Take your next dose at the regular time. Do not||
0510|191|D|double the dose to catch up.||
0510|192|B|||
0510|193|R|STORAGE:  Store at room temperature away from light and moisture.||
0510|194|R|Do not store in the bathroom. Keep all medications away from||
0510|195|R|children and pets.||
0510|196|R|   Do not flush medications down the toilet or pour them into a||
0510|197|R|drain unless instructed to do so. Properly discard this product||
0510|198|R|when it is expired or no longer needed. Consult your pharmacist||
0510|199|R|or local waste disposal company.||
0510|200|B|||
0510|201|A|Information last revised April 2025.||
0510|202|A|Copyright(c) 2025 First Databank, Inc.||
0510|203|B|||
0512|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0512|002|Z|does NOT have all possible information about this product. This||
0512|003|Z|information does not assure that this product is safe, effective,||
0512|004|Z|or appropriate for you. This information is not individual||
0512|005|Z|medical advice and does not substitute for the advice of your||
0512|006|Z|health care professional. Always ask your health care||
0512|007|Z|professional for complete information about this product and your||
0512|008|Z|specific health needs.||
0512|009|B|||
0512|010|T|SOLIFENACIN - ORAL||
0512|011|F|(SOE-li-FEN-a-sin)||
0512|012|B|||
0512|013|C|COMMON BRAND NAME(S): Vesicare, Vesicare LS||
0512|014|B|||
0512|015|U|USES:  Solifenacin is used to treat an overactive bladder. By||
0512|016|U|relaxing the muscles in the bladder, solifenacin improves your||
0512|017|U|ability to control your urination. It helps to reduce leaking of||
0512|018|U|urine, feelings of needing to urinate right away, and frequent||
0512|019|U|trips to the bathroom. This medication belongs to the class of||
0512|020|U|drugs known as antispasmodics.||
0512|021|B|||
0512|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0512|023|H|from your pharmacist before you start using solifenacin and each||
0512|024|H|time you get a refill. If you have any questions, ask your doctor||
0512|025|H|or pharmacist.||
0512|026|H|   Take this medication by mouth with or without food as directed||
0512|027|H|by your doctor, usually once a day. Take it with a full glass of||
0512|028|H|liquid. Swallow the tablet whole because the powder in the tablet||
0512|029|H|has a bitter taste.||
0512|030|H|   If you are using the liquid form of this medication, shake the||
0512|031|H|bottle well before taking each dose. Carefully measure the dose||
0512|032|H|using a special measuring device/spoon. Do not use a household||
0512|033|H|spoon because you may not get the correct dose. After taking your||
0512|034|H|dose, drink a glass of water or milk. Avoid taking the liquid||
0512|035|H|form with food or other drinks, as this may cause a bitter taste.||
0512|036|H|   Use this medication regularly to get the most benefit from it.||
0512|037|H|To help you remember, take it at the same time each day.||
0512|038|H|   The dosage is based on your medical condition, response to||
0512|039|H|treatment, and other medications you may be taking. Children's||
0512|040|H|dosage is also based on weight. Be sure to tell your doctor and||
0512|041|H|pharmacist about all the products you use (including prescription||
0512|042|H|drugs, nonprescription drugs, and herbal products).||
0512|043|H|   Do not increase your dose or use this drug more often or for||
0512|044|H|longer than prescribed. Your condition will not improve any||
0512|045|H|faster, and your risk of side effects will increase.||
0512|046|H|   Tell your doctor if your condition does not get better or if||
0512|047|H|it gets worse.||
0512|048|B|||
0512|049|S|SIDE EFFECTS:  Dry mouth, constipation, drowsiness, stomach||
0512|050|S|upset, blurred vision, dry eyes, headache, or unusual||
0512|051|S|tiredness/weakness may occur. If any of these effects last or get||
0512|052|S|worse, tell your doctor or pharmacist promptly.||
0512|053|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0512|054|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0512|055|S|substitute.||
0512|056|S|   To prevent constipation, eat dietary fiber, drink enough||
0512|057|S|water, and exercise. You may also need to take a laxative. Ask||
0512|058|S|your pharmacist which type of laxative is right for you.||
0512|059|S|   Remember that this medication has been prescribed because your||
0512|060|S|doctor has judged that the benefit to you is greater than the||
0512|061|S|risk of side effects. Many people using this medication do not||
0512|062|S|have serious side effects.||
0512|063|S|   Tell your doctor right away if you have any serious side||
0512|064|S|effects, including: severe stomach/abdominal pain, constipation||
0512|065|S|for 3 or more days, difficulty urinating, signs of kidney||
0512|066|S|infection (such as burning/painful/frequent urination, fever,||
0512|067|S|pink/bloody urine), mental/mood changes (such as confusion,||
0512|068|S|hallucinations).||
0512|069|S|   Get medical help right away if you have any very serious side||
0512|070|S|effects, including: eye pain/swelling/redness, vision changes||
0512|071|S|(such as seeing rainbows around lights at night).||
0512|072|S|   A very serious allergic reaction to this drug is rare.||
0512|073|S|However, get medical help right away if you notice any symptoms||
0512|074|S|of a serious allergic reaction, including: rash, itching/swelling||
0512|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0512|076|S|breathing.||
0512|077|S|   This is not a complete list of possible side effects. If you||
0512|078|S|notice other effects not listed above, contact your doctor or||
0512|079|S|pharmacist.||
0512|080|S|   In the US -||
0512|081|S|   Call your doctor for medical advice about side effects. You||
0512|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0512|083|S|www.fda.gov/medwatch.||
0512|084|S|   In Canada - Call your doctor for medical advice about side||
0512|085|S|effects. You may report side effects to Health Canada at||
0512|086|S|1-866-234-2345.||
0512|087|B|||
0512|088|P|PRECAUTIONS:  Before taking solifenacin, tell your doctor or||
0512|089|P|pharmacist if you are allergic to it; or if you have any other||
0512|090|P|allergies. This product may contain inactive ingredients, which||
0512|091|P|can cause allergic reactions or other problems. Talk to your||
0512|092|P|pharmacist for more details.||
0512|093|P|   Before using this medication, tell your doctor or pharmacist||
0512|094|P|your medical history, especially of: difficulty urinating||
0512|095|P|(urinary retention), other bladder problems (such as blockage),||
0512|096|P|stomach/intestinal blockage (gastric retention), personal or||
0512|097|P|family history of glaucoma (angle-closure type), liver disease,||
0512|098|P|bowel disease (such as ulcerative colitis), slowed movement of||
0512|099|P|stomach/intestines, constipation, kidney disease, enlarged||
0512|100|P|prostate, a certain muscle/nerve disease (myasthenia gravis).||
0512|101|P|   This drug may make you drowsy or blur your vision. Alcohol or||
0512|102|P|marijuana (cannabis) can make you more drowsy. Do not drive, use||
0512|103|P|machinery, or do anything that needs alertness or clear vision||
0512|104|P|until you can do it safely. Limit alcoholic beverages. Talk to||
0512|105|P|your doctor if you are using marijuana (cannabis).||
0512|106|P|   Before having surgery, tell your doctor or dentist about all||
0512|107|P|the products you use (including prescription drugs,||
0512|108|P|nonprescription drugs, and herbal products).||
0512|109|P|   This medication may make you sweat less, making you more||
0512|110|P|likely to get heat stroke. Avoid doing things that may cause you||
0512|111|P|to overheat, such as hard work or exercise in hot weather, or||
0512|112|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0512|113|P|and dress lightly. If you overheat, quickly look for a place to||
0512|114|P|cool down and rest. Get medical help right away if you have a||
0512|115|P|fever that does not go away, mental/mood changes, headache, or||
0512|116|P|dizziness.||
0512|117|P|   Older adults may be more sensitive to the side effects of this||
0512|118|P|drug, especially drowsiness, confusion, constipation, or trouble||
0512|119|P|urinating. Drowsiness and confusion can increase the risk of||
0512|120|P|falling.||
0512|121|P|   During pregnancy, this medication should be used only when||
0512|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
0512|123|P|   It is unknown if this medication passes into breast milk.||
0512|124|P|Consult your doctor before breastfeeding.||
0512|125|B|||
0512|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0512|127|I|medications work or increase your risk for serious side effects.||
0512|128|I|This document does not contain all possible drug interactions.||
0512|129|I|Keep a list of all the products you use (including||
0512|130|I|prescription/nonprescription drugs and herbal products) and share||
0512|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
0512|132|I|the dosage of any medicines without your doctor's approval.||
0512|133|I|   Some products that may interact with this drug include:||
0512|134|I|pramlintide, potassium tablets/capsules.||
0512|135|I|   Other medications can affect the removal of solifenacin from||
0512|136|I|your body, which may affect how solifenacin works. Examples||
0512|137|I|include certain azole antifungals (such as itraconazole,||
0512|138|I|ketoconazole), mifepristone, among others.||
0512|139|B|||
0512|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0512|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0512|142|O|poison control center right away. US residents can call||
0512|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0512|144|O|Symptoms of overdose may include fast/irregular heartbeat,||
0512|145|O|agitation.||
0512|146|B|||
0512|147|N|NOTES:  Do not share this medication with others.||
0512|148|B|||
0512|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0512|150|D|remember. If it is more than 12 hours after the missed dose, skip||
0512|151|D|the missed dose. Take your next dose at the regular time on the||
0512|152|D|next day. Do not double the dose to catch up.||
0512|153|B|||
0512|154|R|STORAGE:  Store at room temperature away from light and moisture.||
0512|155|R|Do not store in the bathroom. Store the liquid form in the||
0512|156|R|original bottle and discard 28 days after opening. Keep all||
0512|157|R|medications away from children and pets.||
0512|158|R|   Do not flush medications down the toilet or pour them into a||
0512|159|R|drain unless instructed to do so. Properly discard this product||
0512|160|R|when it is expired or no longer needed. Consult your pharmacist||
0512|161|R|or local waste disposal company.||
0512|162|B|||
0512|163|A|Information last revised October 2024.||
0512|164|A|Copyright(c) 2025 First Databank, Inc.||
0512|165|B|||
0513|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0513|002|Z|does NOT have all possible information about this product. This||
0513|003|Z|information does not assure that this product is safe, effective,||
0513|004|Z|or appropriate for you. This information is not individual||
0513|005|Z|medical advice and does not substitute for the advice of your||
0513|006|Z|health care professional. Always ask your health care||
0513|007|Z|professional for complete information about this product and your||
0513|008|Z|specific health needs.||
0513|009|B|||
0513|010|T|DARIFENACIN EXTENDED-RELEASE - ORAL||
0513|011|F|(DAR-i-FEN-a-sin)||
0513|012|B|||
0513|013|C|COMMON BRAND NAME(S): Enablex||
0513|014|B|||
0513|015|U|USES:  Darifenacin is used to treat an overactive bladder. By||
0513|016|U|relaxing the muscles in the bladder, darifenacin improves your||
0513|017|U|ability to control your urination. It helps to reduce leaking of||
0513|018|U|urine, feelings of needing to urinate right away, and frequent||
0513|019|U|trips to the bathroom. This medication belongs to the class of||
0513|020|U|drugs known as antispasmodics.||
0513|021|B|||
0513|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0513|023|H|from your pharmacist before you start using darifenacin and each||
0513|024|H|time you get a refill. If you have any questions, ask your doctor||
0513|025|H|or pharmacist.||
0513|026|H|   Take this medication by mouth with or without food as directed||
0513|027|H|by your doctor, usually once a day. Swallow this medication with||
0513|028|H|a full glass of water (8 ounces/240 milliliters).||
0513|029|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
0513|030|H|Doing so can release all of the drug at once, increasing the risk||
0513|031|H|of side effects.||
0513|032|H|   Use this medication regularly to get the most benefit from it.||
0513|033|H|To help you remember, take it at the same time each day.||
0513|034|H|   The dosage is based on your medical condition, response to||
0513|035|H|treatment, and other medications you may be taking. Be sure to||
0513|036|H|tell your doctor and pharmacist about all the products you use||
0513|037|H|(including prescription drugs, nonprescription drugs, and herbal||
0513|038|H|products).||
0513|039|H|   Do not increase your dose or use this drug more often or for||
0513|040|H|longer than prescribed. Your condition will not improve any||
0513|041|H|faster, and your risk of side effects will increase.||
0513|042|H|   Tell your doctor if your condition does not get better or if||
0513|043|H|it gets worse.||
0513|044|B|||
0513|045|S|SIDE EFFECTS:  Dry mouth, constipation, nausea, stomach upset,||
0513|046|S|stomach pain, blurred vision, dry eyes, dizziness, or weakness||
0513|047|S|may occur. If any of these effects last or get worse, tell your||
0513|048|S|doctor or pharmacist promptly.||
0513|049|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0513|050|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0513|051|S|substitute.||
0513|052|S|   To prevent constipation, eat dietary fiber, drink enough||
0513|053|S|water, and exercise. You may also need to take a laxative. Ask||
0513|054|S|your pharmacist which type of laxative is right for you.||
0513|055|S|   Remember that this medication has been prescribed because your||
0513|056|S|doctor has judged that the benefit to you is greater than the||
0513|057|S|risk of side effects. Many people using this medication do not||
0513|058|S|have serious side effects.||
0513|059|S|   Tell your doctor right away if you have any serious side||
0513|060|S|effects, including: severe stomach/abdominal pain, constipation||
0513|061|S|for 3 or more days, difficulty urinating, signs of kidney||
0513|062|S|infection (such as burning/painful/frequent urination, fever,||
0513|063|S|pink/bloody urine), mental/mood changes (such as confusion,||
0513|064|S|hallucinations).||
0513|065|S|   Get medical help right away if you have any very serious side||
0513|066|S|effects, including: eye pain/swelling/redness, vision changes||
0513|067|S|(such as seeing rainbows around lights at night).||
0513|068|S|   A very serious allergic reaction to this drug is rare.||
0513|069|S|However, get medical help right away if you notice any symptoms||
0513|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0513|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0513|072|S|breathing.||
0513|073|S|   This is not a complete list of possible side effects. If you||
0513|074|S|notice other effects not listed above, contact your doctor or||
0513|075|S|pharmacist.||
0513|076|S|   In the US -||
0513|077|S|   Call your doctor for medical advice about side effects. You||
0513|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0513|079|S|www.fda.gov/medwatch.||
0513|080|S|   In Canada - Call your doctor for medical advice about side||
0513|081|S|effects. You may report side effects to Health Canada at||
0513|082|S|1-866-234-2345.||
0513|083|B|||
0513|084|P|PRECAUTIONS:  Before taking darifenacin, tell your doctor or||
0513|085|P|pharmacist if you are allergic to it; or if you have any other||
0513|086|P|allergies. This product may contain inactive ingredients, which||
0513|087|P|can cause allergic reactions or other problems. Talk to your||
0513|088|P|pharmacist for more details.||
0513|089|P|   Before using this medication, tell your doctor or pharmacist||
0513|090|P|your medical history, especially of: difficulty urinating||
0513|091|P|(urinary retention), other bladder problems (such as bladder||
0513|092|P|outflow obstruction), stomach/intestinal blockage (gastric||
0513|093|P|retention), liver disease, personal or family history of glaucoma||
0513|094|P|(angle-closure type), bowel disease (such as ulcerative colitis),||
0513|095|P|slowed movement of stomach/intestines, constipation, enlarged||
0513|096|P|prostate, a certain muscle/nerve disease (myasthenia gravis).||
0513|097|P|   This drug may make you dizzy or blur your vision. Alcohol or||
0513|098|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
0513|099|P|machinery, or do anything that needs alertness or clear vision||
0513|100|P|until you can do it safely. Limit alcoholic beverages. Talk to||
0513|101|P|your doctor if you are using marijuana (cannabis).||
0513|102|P|   Before having surgery, tell your doctor or dentist about all||
0513|103|P|the products you use (including prescription drugs,||
0513|104|P|nonprescription drugs, and herbal products).||
0513|105|P|   This medication may make you sweat less, making you more||
0513|106|P|likely to get heat stroke. Avoid doing things that may cause you||
0513|107|P|to overheat, such as hard work or exercise in hot weather, or||
0513|108|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0513|109|P|and dress lightly. If you overheat, quickly look for a place to||
0513|110|P|cool down and rest. Get medical help right away if you have a||
0513|111|P|fever that does not go away, mental/mood changes, headache, or||
0513|112|P|dizziness.||
0513|113|P|   During pregnancy, this medication should be used only when||
0513|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
0513|115|P|   It is unknown if this medication passes into breast milk.||
0513|116|P|Consult your doctor before breastfeeding.||
0513|117|B|||
0513|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0513|119|I|medications work or increase your risk for serious side effects.||
0513|120|I|This document does not contain all possible drug interactions.||
0513|121|I|Keep a list of all the products you use (including||
0513|122|I|prescription/nonprescription drugs and herbal products) and share||
0513|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
0513|124|I|the dosage of any medicines without your doctor's approval.||
0513|125|I|   Some products that may interact with this drug include:||
0513|126|I|mifepristone, pramlintide, potassium tablets/capsules.||
0513|127|B|||
0513|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0513|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0513|130|O|poison control center right away. US residents can call||
0513|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0513|132|O|Symptoms of overdose may include fast/irregular heartbeat,||
0513|133|O|agitation.||
0513|134|B|||
0513|135|N|NOTES:  Do not share this medication with others.||
0513|136|B|||
0513|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0513|138|D|remember. If it is near the time of the next dose, skip the||
0513|139|D|missed dose. Take your next dose at the regular time. Do not||
0513|140|D|double the dose to catch up.||
0513|141|B|||
0513|142|R|STORAGE:  Store at room temperature away from light and moisture.||
0513|143|R|Do not store in the bathroom. Keep all medications away from||
0513|144|R|children and pets.||
0513|145|R|   Do not flush medications down the toilet or pour them into a||
0513|146|R|drain unless instructed to do so. Properly discard this product||
0513|147|R|when it is expired or no longer needed. Consult your pharmacist||
0513|148|R|or local waste disposal company.||
0513|149|B|||
0513|150|A|Information last revised October 2024.||
0513|151|A|Copyright(c) 2025 First Databank, Inc.||
0513|152|B|||
0514|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0514|002|Z|does NOT have all possible information about this product. This||
0514|003|Z|information does not assure that this product is safe, effective,||
0514|004|Z|or appropriate for you. This information is not individual||
0514|005|Z|medical advice and does not substitute for the advice of your||
0514|006|Z|health care professional. Always ask your health care||
0514|007|Z|professional for complete information about this product and your||
0514|008|Z|specific health needs.||
0514|009|B|||
0514|010|T|DIPHTHERIA/TETANUS/PERTUSSIS VACCINE - INJECTION||
0514|011|F|(dip-THEER-ee-uh/TET-un-us/per-TUSS-iss)||
0514|012|B|||
0514|013|C|COMMON BRAND NAME(S): Adacel, Boostrix||
0514|014|B|||
0514|015|U|USES:  This vaccine is used to help prevent diphtheria, tetanus||
0514|016|U|(lockjaw), and pertussis (whooping cough) in children and adults||
0514|017|U|who have been vaccinated for these diseases in the past. It may||
0514|018|U|also be used during the third trimester of pregnancy to help||
0514|019|U|prevent pertussis in the newborn baby. Vaccination is the best||
0514|020|U|way to protect against these life-threatening diseases. This||
0514|021|U|vaccine works by increasing the body's natural defense (immunity)||
0514|022|U|against the bacteria. Booster doses of this vaccine are needed||
0514|023|U|since immunity can decrease over time.||
0514|024|U|   Vaccines may not fully protect everyone who receives them.||
0514|025|B|||
0514|026|H|HOW TO USE:  Read all vaccine information available from your||
0514|027|H|health care professional before receiving the vaccine. If you||
0514|028|H|have any questions, ask your health care professional.||
0514|029|H|   This medication is given by injection into the muscle of the||
0514|030|H|upper arm by a health care professional.||
0514|031|H|   This vaccine may be given at the same time as other vaccines.||
0514|032|B|||
0514|033|S|SIDE EFFECTS:  Pain/swelling/redness at the injection site,||
0514|034|S|headache, tiredness, body aches, nausea, diarrhea, fever, chills,||
0514|035|S|vomiting, or sore/swollen joints may occur. If any of these||
0514|036|S|effects last or get worse, tell your health care professional||
0514|037|S|promptly.||
0514|038|S|   Rarely, some people have symptoms such as fainting, dizziness,||
0514|039|S|vision changes, or ringing in the ears just after getting a||
0514|040|S|vaccine injection. Tell your health care professional right away||
0514|041|S|if you have any of these symptoms. Sitting or lying down may||
0514|042|S|help, since these symptoms usually don't last long.||
0514|043|S|   Remember that this vaccine has been prescribed because your||
0514|044|S|health care professional has judged that the benefit to you is||
0514|045|S|greater than the risk of side effects. Many people using this||
0514|046|S|vaccine do not have serious side effects.||
0514|047|S|   Tell your health care professional right away if you have any||
0514|048|S|serious side effects, including: high fever (105 degrees F/40||
0514|049|S|degrees C or higher), seizures, numbness/tingling, muscle||
0514|050|S|weakness, severe pain/swelling at the injection site.||
0514|051|S|   A very serious allergic reaction to this vaccine is rare.||
0514|052|S|However, get medical help right away if you notice any symptoms||
0514|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0514|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0514|055|S|breathing.||
0514|056|S|   This is not a complete list of possible side effects. If you||
0514|057|S|notice other effects not listed above, contact your health care||
0514|058|S|professional.||
0514|059|S|   Contact the health care professional for medical advice about||
0514|060|S|side effects. The following numbers do not provide medical||
0514|061|S|advice, but in the US you may report side effects to the Vaccine||
0514|062|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
0514|063|S|Canada, you may call the Vaccine Safety Section at Public Health||
0514|064|S|Agency of Canada at 1-866-844-0018.||
0514|065|B|||
0514|066|P|PRECAUTIONS:  Before you receive this vaccine, tell your health||
0514|067|P|care professional if you are allergic to it; or if you have any||
0514|068|P|other allergies. This product may contain inactive ingredients||
0514|069|P|(such as latex found in some brands), which can cause allergic||
0514|070|P|reactions or other problems. Talk to your health care||
0514|071|P|professional for more details.||
0514|072|P|   Before receiving this vaccine, tell your health care||
0514|073|P|professional your medical history, especially of: current||
0514|074|P|fever/illness, nervous system disorders (such as seizures,||
0514|075|P|encephalopathy, Guillain-Barre syndrome), immune system disorders||
0514|076|P|(such as due to HIV infection, certain cancers such as||
0514|077|P|leukemia/lymphoma, cancer or radiation treatment), vaccination||
0514|078|P|history (including previous reactions to any vaccines).||
0514|079|P|   During pregnancy, this vaccine is usually recommended. Discuss||
0514|080|P|the risks and benefits with your health care professional.||
0514|081|P|   It is unknown if this vaccine passes into breast milk. Consult||
0514|082|P|your health care professional before breastfeeding.||
0514|083|B|||
0514|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0514|085|I|medications work or increase your risk for serious side effects.||
0514|086|I|This document does not contain all possible drug interactions.||
0514|087|I|Keep a list of all the products you use (including||
0514|088|I|prescription/nonprescription drugs and herbal products) and share||
0514|089|I|it with your health care professional. Do not start, stop, or||
0514|090|I|change the dosage of any medicines without your doctor's||
0514|091|I|approval.||
0514|092|I|   Some products that may interact with this vaccine are: drugs||
0514|093|I|that weaken the immune system (including cyclosporine,||
0514|094|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
0514|095|I|prednisone).||
0514|096|B|||
0514|097|O|OVERDOSE:  Not applicable.||
0514|098|B|||
0514|099|N|NOTES:  Keep all medical and lab appointments.||
0514|100|N|   Keep vaccine records for yourself and your children and||
0514|101|N|provide them to the health care professionals to prevent||
0514|102|N|unnecessary re-vaccinations.||
0514|103|B|||
0514|104|D|MISSED DOSE:  It is important that you get each vaccination as||
0514|105|D|scheduled. Ask when you should get each dose and mark your||
0514|106|D|calendar with a reminder. If you miss a dose, call the health||
0514|107|D|care professional to reschedule.||
0514|108|B|||
0514|109|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
0514|110|R|medications away from children and pets.||
0514|111|R|   Do not flush medications down the toilet or pour them into a||
0514|112|R|drain unless instructed to do so. Properly discard this product||
0514|113|R|when it is expired or no longer needed. Consult your pharmacist||
0514|114|R|or local waste disposal company.||
0514|115|B|||
0514|116|A|Information last revised February 2025.||
0514|117|A|Copyright(c) 2025 First Databank, Inc.||
0514|118|B|||
0517|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0517|002|Z|does NOT have all possible information about this product. This||
0517|003|Z|information does not assure that this product is safe, effective,||
0517|004|Z|or appropriate for you. This information is not individual||
0517|005|Z|medical advice and does not substitute for the advice of your||
0517|006|Z|health care professional. Always ask your health care||
0517|007|Z|professional for complete information about this product and your||
0517|008|Z|specific health needs.||
0517|009|B|||
0517|010|T|DINOPROSTONE INSERT - VAGINAL||
0517|011|F|(dye-no-PROST-own)||
0517|012|B|||
0517|013|C|COMMON BRAND NAME(S): Cervidil||
0517|014|B|||
0517|015|U|USES:  This medication is used to help prepare your cervix (the||
0517|016|U|lower opening of the womb) for labor and delivery. It is used in||
0517|017|U|women who are having a normal pregnancy and who are at or near||
0517|018|U|their delivery due date. Dinoprostone is a natural substance that||
0517|019|U|your body makes in preparation for labor. It relaxes and softens||
0517|020|U|your cervix (cervical ripening) to allow the baby to pass through||
0517|021|U|the birth canal during delivery.||
0517|022|B|||
0517|023|H|HOW TO USE:  This drug is inserted high in your vagina next to||
0517|024|H|the cervix by a health care professional. You will be lying down||
0517|025|H|while the medication is placed, and you will usually need to||
0517|026|H|continue lying down for 2 hours after insertion. The health care||
0517|027|H|professional will tell you when you can get up and walk around.||
0517|028|H|   This medication should only be used in a hospital setting with||
0517|029|H|trained medical care available. You will be monitored for changes||
0517|030|H|in your cervix, for signs of active labor (such as water||
0517|031|H|breaking, strong sustained contractions), and for your baby's||
0517|032|H|condition. The health care professional will remove the insert if||
0517|033|H|there are side effects, after 12 hours, or when it is no longer||
0517|034|H|needed. The drug's effects wear off quickly after the insert is||
0517|035|H|removed.||
0517|036|B|||
0517|037|S|SIDE EFFECTS:  Side effects such as fever, nausea, vomiting,||
0517|038|S|diarrhea, or abdominal pain are uncommon and usually mild. If any||
0517|039|S|of these effects last or get worse, tell your doctor or midwife||
0517|040|S|right away.||
0517|041|S|   Remember that this medication has been prescribed because your||
0517|042|S|doctor has judged that the benefit to you is greater than the||
0517|043|S|risk of side effects. Many people using this medication do not||
0517|044|S|have serious side effects.||
0517|045|S|   Tell your doctor right away if you have any serious side||
0517|046|S|effects, including: strong contractions that are very close||
0517|047|S|together (uterine overstimulation).||
0517|048|S|   Get medical help right away if you have any very serious side||
0517|049|S|effects, including: easy bruising/bleeding, shortness of breath,||
0517|050|S|chest pain, confusion.||
0517|051|S|   This drug has rarely caused injury to the womb (uterine||
0517|052|S|rupture), which may require emergency surgery. Symptoms include||
0517|053|S|severe pain in your womb and an abnormal heart rate in your baby.||
0517|054|S|Careful monitoring by your doctor or midwife may decrease your||
0517|055|S|risk.||
0517|056|S|   A very serious allergic reaction to this drug is rare.||
0517|057|S|However, get medical help right away if you notice any symptoms||
0517|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0517|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0517|060|S|breathing.||
0517|061|S|   This is not a complete list of possible side effects. If you||
0517|062|S|notice other effects not listed above, contact your doctor or||
0517|063|S|pharmacist.||
0517|064|S|   In the US -||
0517|065|S|   Call your doctor for medical advice about side effects. You||
0517|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0517|067|S|www.fda.gov/medwatch.||
0517|068|S|   In Canada - Call your doctor for medical advice about side||
0517|069|S|effects. You may report side effects to Health Canada at||
0517|070|S|1-866-234-2345.||
0517|071|B|||
0517|072|P|PRECAUTIONS:  Before using dinoprostone, tell your doctor,||
0517|073|P|midwife, or pharmacist if you are allergic to it; or if you have||
0517|074|P|any other allergies. This product may contain inactive||
0517|075|P|ingredients, which can cause allergic reactions or other||
0517|076|P|problems. Talk to your pharmacist for more details.||
0517|077|P|   Before using this drug, tell your doctor your medical history,||
0517|078|P|including: asthma, full term births including previous cesarean||
0517|079|P|section (c-section) births, glaucoma, infections in the vaginal||
0517|080|P|area (such as genital herpes), surgery on the cervix, surgery on||
0517|081|P|the womb (uterus), vaginal bleeding during pregnancy, womb||
0517|082|P|scarring.||
0517|083|P|   This drug should not be used if you are carrying more than one||
0517|084|P|baby, if your labor has already started, or if your water has||
0517|085|P|broken.||
0517|086|P|   During pregnancy, this medication should be used only when||
0517|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
0517|088|P|   It is unknown if this drug passes into breast milk. Consult||
0517|089|P|your doctor before breastfeeding.||
0517|090|B|||
0517|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0517|092|I|medications work or increase your risk for serious side effects.||
0517|093|I|This document does not contain all possible drug interactions.||
0517|094|I|Keep a list of all the products you use (including||
0517|095|I|prescription/nonprescription drugs and herbal products) and share||
0517|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
0517|097|I|the dosage of any medicines without your doctor's approval.||
0517|098|I|   Some products that may interact with this drug include: other||
0517|099|I|prostaglandins (such as misoprostol), oxytocin.||
0517|100|B|||
0517|101|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0517|102|O|has overdosed and has serious symptoms such as passing out or||
0517|103|O|trouble breathing, call 911. Otherwise, call a poison control||
0517|104|O|center right away. US residents can call 1-800-222-1222. Canada||
0517|105|O|residents can call 1-844-764-7669.||
0517|106|B|||
0517|107|N|NOTES:  Use under direct medical supervision.||
0517|108|B|||
0517|109|D|MISSED DOSE:  Not applicable.||
0517|110|B|||
0517|111|R|STORAGE:  Store in a freezer away from light and moisture.||
0517|112|R|   Do not flush medications down the toilet or pour them into a||
0517|113|R|drain unless instructed to do so. Properly discard this product||
0517|114|R|when it is expired or no longer needed. Consult your pharmacist||
0517|115|R|or local waste disposal company.||
0517|116|B|||
0517|117|A|Information last revised May 2024.||
0517|118|A|Copyright(c) 2025 First Databank, Inc.||
0517|119|B|||
0518|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0518|002|Z|does NOT have all possible information about this product. This||
0518|003|Z|information does not assure that this product is safe, effective,||
0518|004|Z|or appropriate for you. This information is not individual||
0518|005|Z|medical advice and does not substitute for the advice of your||
0518|006|Z|health care professional. Always ask your health care||
0518|007|Z|professional for complete information about this product and your||
0518|008|Z|specific health needs.||
0518|009|B|||
0518|010|T|AMPICILLIN - ORAL||
0518|011|F|(AM-pi-SIL-in)||
0518|012|B|||
0518|013|C|COMMON BRAND NAME(S): Principen||
0518|014|B|||
0518|015|U|USES:  Ampicillin is used to treat a wide variety of bacterial||
0518|016|U|infections. It is a penicillin-type antibiotic. It works by||
0518|017|U|stopping the growth of bacteria.||
0518|018|U|   This antibiotic treats only bacterial infections. It will not||
0518|019|U|work for viral infections (such as common cold, flu). Using any||
0518|020|U|antibiotic when it is not needed can cause it to not work for||
0518|021|U|future infections.||
0518|022|B|||
0518|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
0518|024|H|doctor, usually 4 times a day (every 6 hours). Take ampicillin on||
0518|025|H|an empty stomach (1 hour before or 2 hours after a meal) with a||
0518|026|H|full glass of water. Drink plenty of fluids while using this||
0518|027|H|medication unless your doctor tells you otherwise.||
0518|028|H|   The dosage is based on your medical condition and response to||
0518|029|H|treatment.||
0518|030|H|   For the best effect, take this antibiotic at evenly spaced||
0518|031|H|times. To help you remember, take this medication at the same||
0518|032|H|time(s) every day.||
0518|033|H|   Continue to take this medication until the full prescribed||
0518|034|H|amount is finished even if symptoms disappear after a few days.||
0518|035|H|Stopping the medication too early may result in a return of the||
0518|036|H|infection.||
0518|037|H|   Tell your doctor if your condition lasts or gets worse.||
0518|038|B|||
0518|039|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, or mouth/tongue sores||
0518|040|S|may occur. If any of these effects last or get worse, tell your||
0518|041|S|doctor or pharmacist promptly.||
0518|042|S|   Remember that this medication has been prescribed because your||
0518|043|S|doctor has judged that the benefit to you is greater than the||
0518|044|S|risk of side effects. Many people using this medication do not||
0518|045|S|have serious side effects.||
0518|046|S|   Tell your doctor right away if you have any serious side||
0518|047|S|effects, including: easy bruising or bleeding, signs of liver||
0518|048|S|disease (such as nausea/vomiting that doesn't stop, loss of||
0518|049|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0518|050|S|urine).||
0518|051|S|   This medication may rarely cause a severe intestinal condition||
0518|052|S|due to a bacteria called C. difficile. This condition may occur||
0518|053|S|during treatment or weeks to months after treatment has stopped.||
0518|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0518|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0518|056|S|stool.||
0518|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0518|058|S|products because they may make symptoms worse.||
0518|059|S|   Use of this medication for prolonged or repeated periods may||
0518|060|S|result in oral thrush or a new vaginal yeast infection (oral or||
0518|061|S|vaginal fungal infection). Contact your doctor if you notice||
0518|062|S|white patches in your mouth, a change in vaginal discharge or||
0518|063|S|other new symptoms.||
0518|064|S|   A very serious allergic reaction to this drug is rare.||
0518|065|S|However, get medical help right away if you notice any symptoms||
0518|066|S|of a serious allergic reaction, including: fever that doesn't go||
0518|067|S|away, new or worsening lymph node swelling, rash,||
0518|068|S|itching/swelling (especially of the face/tongue/throat), severe||
0518|069|S|dizziness, trouble breathing.||
0518|070|S|   Ampicillin can commonly cause a mild rash that is usually not||
0518|071|S|serious. However, you may not be able to tell it apart from a||
0518|072|S|rare rash that could be a sign of a severe allergic reaction. Get||
0518|073|S|medical help right away if you develop any rash.||
0518|074|S|   This is not a complete list of possible side effects. If you||
0518|075|S|notice other effects not listed above, contact your doctor or||
0518|076|S|pharmacist.||
0518|077|S|   In the US -||
0518|078|S|   Call your doctor for medical advice about side effects. You||
0518|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0518|080|S|www.fda.gov/medwatch.||
0518|081|S|   In Canada - Call your doctor for medical advice about side||
0518|082|S|effects. You may report side effects to Health Canada at||
0518|083|S|1-866-234-2345.||
0518|084|B|||
0518|085|P|PRECAUTIONS:  Before taking ampicillin, tell your doctor or||
0518|086|P|pharmacist if you are allergic to it; or to penicillin or||
0518|087|P|cephalosporin antibiotics; or if you have any other allergies.||
0518|088|P|This product may contain inactive ingredients, which can cause||
0518|089|P|allergic reactions or other problems. Talk to your pharmacist for||
0518|090|P|more details.||
0518|091|P|   Before using this medication, tell your doctor or pharmacist||
0518|092|P|your medical history, especially of: kidney disease, a certain||
0518|093|P|type of viral infection (infectious mononucleosis).||
0518|094|P|   Ampicillin may cause live bacterial vaccines (such as typhoid||
0518|095|P|vaccine) to not work well. Tell your health care professional||
0518|096|P|that you are using ampicillin before having any||
0518|097|P|immunizations/vaccinations.||
0518|098|P|   Older adults may be at greater risk for side effects while||
0518|099|P|using this drug.||
0518|100|P|   During pregnancy, this medication should be used only when||
0518|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
0518|102|P|   Ampicillin passes into breast milk. Consult your doctor before||
0518|103|P|breastfeeding.||
0518|104|B|||
0518|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0518|106|I|medications work or increase your risk for serious side effects.||
0518|107|I|This document does not contain all possible drug interactions.||
0518|108|I|Keep a list of all the products you use (including||
0518|109|I|prescription/nonprescription drugs and herbal products) and share||
0518|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0518|111|I|the dosage of any medicines without your doctor's approval.||
0518|112|I|   Some products that may interact with this drug include:||
0518|113|I|methotrexate, tetracyclines.||
0518|114|I|   This medication may interfere with certain lab tests (such as||
0518|115|I|certain diabetic urine tests), possibly causing false test||
0518|116|I|results. Make sure lab personnel and all your doctors know you||
0518|117|I|use this drug.||
0518|118|B|||
0518|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0518|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0518|121|O|poison control center right away. US residents can call||
0518|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0518|123|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
0518|124|O|severe vomiting, unusual change in the amount of urine, or||
0518|125|O|seizures.||
0518|126|B|||
0518|127|N|NOTES:  Do not share this medication with others.||
0518|128|N|   This medication has been prescribed for your current condition||
0518|129|N|only. Do not use it later for another infection unless your||
0518|130|N|doctor tells you to.||
0518|131|N|   If you are using this drug for a long time, lab and/or medical||
0518|132|N|tests (such as kidney/liver function, complete blood count)||
0518|133|N|should be done while you are taking this medication. Keep all||
0518|134|N|medical and lab appointments. Consult your doctor for more||
0518|135|N|details.||
0518|136|B|||
0518|137|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0518|138|D|If it is near the time of the next dose, skip the missed dose.||
0518|139|D|Use your next dose at the regular time. Do not double the dose to||
0518|140|D|catch up.||
0518|141|B|||
0518|142|R|STORAGE:  Store at room temperature away from light and moisture.||
0518|143|R|Do not store in the bathroom. Keep all medications away from||
0518|144|R|children and pets.||
0518|145|R|   Do not flush medications down the toilet or pour them into a||
0518|146|R|drain unless instructed to do so. Properly discard this product||
0518|147|R|when it is expired or no longer needed. Consult your pharmacist||
0518|148|R|or local waste disposal company.||
0518|149|B|||
0518|150|A|Information last revised February 2025.||
0518|151|A|Copyright(c) 2025 First Databank, Inc.||
0518|152|B|||
0520|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0520|002|Z|does NOT have all possible information about this product. This||
0520|003|Z|information does not assure that this product is safe, effective,||
0520|004|Z|or appropriate for you. This information is not individual||
0520|005|Z|medical advice and does not substitute for the advice of your||
0520|006|Z|health care professional. Always ask your health care||
0520|007|Z|professional for complete information about this product and your||
0520|008|Z|specific health needs.||
0520|009|B|||
0520|010|T|TIPRANAVIR - ORAL||
0520|011|F|(tie-PRAN-ah-veer)||
0520|012|B|||
0520|013|C|COMMON BRAND NAME(S): Aptivus||
0520|014|B|||
0520|015|W|WARNING:  Tipranavir must be given with ritonavir to work||
0520|016|W|effectively. When these two drugs are combined, there have been||
0520|017|W|rare (sometimes fatal) cases of severe liver problems. Your||
0520|018|W|doctor will monitor you closely and perform simple blood tests||
0520|019|W|while you use this medication, especially if you also have||
0520|020|W|infections that affect the liver (chronic hepatitis B or||
0520|021|W|hepatitis C).||
0520|022|W|   Patients being treated with tipranavir and ritonavir may||
0520|023|W|rarely have a serious (sometimes fatal) bleeding problem in the||
0520|024|W|brain (intracranial hemorrhage). This effect may be due to other||
0520|025|W|drugs you are taking or conditions you may have, so do not stop||
0520|026|W|taking tipranavir and ritonavir without consulting your doctor.||
0520|027|W|   Get medical help right away if you develop severe||
0520|028|W|stomach/abdominal pain, unusual tiredness, loss of appetite, dark||
0520|029|W|urine, yellowing eyes/skin, unusual bleeding or bruising, or||
0520|030|W|mental/mood changes.||
0520|031|B|||
0520|032|U|USES:  This drug must be used with other HIV medications to help||
0520|033|U|control HIV infection. It helps to decrease the amount of HIV in||
0520|034|U|your body so your immune system can work better. This lowers your||
0520|035|U|chance of getting HIV complications (such as new infections,||
0520|036|U|cancer) and improves your quality of life.||
0520|037|U|   Tipranavir belongs to a class of drugs known as protease||
0520|038|U|inhibitors. It must be given with ritonavir, another protease||
0520|039|U|inhibitor, to increase ("boost") the levels of tipranavir. This||
0520|040|U|helps tipranavir work better.||
0520|041|U|   Tipranavir is not a cure for HIV infection. To decrease your||
0520|042|U|risk of spreading HIV disease to others, continue to take all HIV||
0520|043|U|medications exactly as prescribed by your doctor. Use an||
0520|044|U|effective barrier method (latex or polyurethane condoms/dental||
0520|045|U|dams) during sexual activity as directed by your doctor. Do not||
0520|046|U|share personal items (such as needles/syringes, toothbrushes, and||
0520|047|U|razors) that may have contacted blood or other body fluids.||
0520|048|U|Consult your doctor or pharmacist for more details.||
0520|049|B|||
0520|050|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0520|051|H|from your pharmacist before you start using tipranavir and each||
0520|052|H|time you get a refill. If you have any questions, ask your doctor||
0520|053|H|or pharmacist.||
0520|054|H|   Take this medication by mouth as directed by your doctor,||
0520|055|H|usually twice daily. Swallow the capsules whole. Do not crush or||
0520|056|H|chew.||
0520|057|H|   Tipranavir must be taken at the same times as ritonavir,||
0520|058|H|another protease inhibitor. Take these medications with meals||
0520|059|H|since ritonavir is usually taken with meals.||
0520|060|H|   It is very important to keep taking this medication (and other||
0520|061|H|HIV medications) exactly as prescribed by your doctor. Do not||
0520|062|H|skip any doses.||
0520|063|H|   For the best effect, take this medication at evenly spaced||
0520|064|H|times. To help you remember, take this medication at the same||
0520|065|H|times every day.||
0520|066|H|   Do not take more or less of this drug than prescribed, or stop||
0520|067|H|taking it (or other HIV medicines) even for a short time, unless||
0520|068|H|directed to do so by your doctor. Skipping or changing your dose||
0520|069|H|without approval from your doctor may cause the amount of virus||
0520|070|H|to increase, make the infection more difficult to treat (develop||
0520|071|H|resistance), or worsen side effects.||
0520|072|B|||
0520|073|S|SIDE EFFECTS:  See also Warning section.||
0520|074|S|   Diarrhea, nausea, drowsiness, dizziness, headache or vomiting||
0520|075|S|may occur. If any of these effects last or get worse, tell your||
0520|076|S|doctor or pharmacist promptly.||
0520|077|S|   Remember that this medication has been prescribed because your||
0520|078|S|doctor has judged that the benefit to you is greater than the||
0520|079|S|risk of side effects. Many people using this medication do not||
0520|080|S|have serious side effects.||
0520|081|S|   As your immune system gets stronger, it can begin to fight off||
0520|082|S|infections you already had, possibly causing disease symptoms to||
0520|083|S|come back. You could also have symptoms if your immune system||
0520|084|S|becomes overactive. This reaction may happen at any time (soon||
0520|085|S|after starting HIV treatment or many months later). Tell your||
0520|086|S|doctor right away if you have any serious symptoms, including:||
0520|087|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
0520|088|S|that doesn't go away, headaches that are severe or don't go away,||
0520|089|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
0520|090|S|changes, signs of infection (such as sore throat that doesn't go||
0520|091|S|away, fever, chills, swollen lymph nodes, non-healing skin||
0520|092|S|sores), signs of an overactive thyroid (such as irritability,||
0520|093|S|nervousness, heat intolerance, fast/pounding/irregular||
0520|094|S|heartbeat).||
0520|095|S|   Tell your doctor right away if you have any serious side||
0520|096|S|effects, including: depression, increased thirst, signs of kidney||
0520|097|S|problems (such as change in the amount of urine).||
0520|098|S|   Get medical help right away if you have any very serious side||
0520|099|S|effects, including: symptoms of a heart attack (such as||
0520|100|S|chest/jaw/left arm pain, shortness of breath, unusual sweating).||
0520|101|S|   Changes in body fat may occur while you are taking this||
0520|102|S|medication (such as increased fat in the upper back and stomach||
0520|103|S|areas, decreased fat in the arms and legs). The cause and||
0520|104|S|long-term effects of these changes are unknown. Discuss the risks||
0520|105|S|and benefits of therapy with your doctor, as well as the possible||
0520|106|S|role of exercise to reduce this side effect.||
0520|107|S|   A very serious allergic reaction to this drug is rare.||
0520|108|S|However, get medical help right away if you notice any symptoms||
0520|109|S|of a serious allergic reaction, including: rash, itching/swelling||
0520|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0520|111|S|breathing.||
0520|112|S|   Tipranavir can commonly cause a mild rash that is usually not||
0520|113|S|serious. However, you may not be able to tell it apart from a||
0520|114|S|rare rash that could be a sign of a severe allergic reaction. Get||
0520|115|S|medical help right away if you develop a rash. Taking estrogen||
0520|116|S|(in birth control or hormone therapy) may increase your risk of||
0520|117|S|developing this rash.||
0520|118|S|   This is not a complete list of possible side effects. If you||
0520|119|S|notice other effects not listed above, contact your doctor or||
0520|120|S|pharmacist.||
0520|121|S|   In the US -||
0520|122|S|   Call your doctor for medical advice about side effects. You||
0520|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0520|124|S|www.fda.gov/medwatch.||
0520|125|S|   In Canada - Call your doctor for medical advice about side||
0520|126|S|effects. You may report side effects to Health Canada at||
0520|127|S|1-866-234-2345.||
0520|128|B|||
0520|129|P|PRECAUTIONS:  Before taking tipranavir, tell your doctor or||
0520|130|P|pharmacist if you are allergic to it; or to sulfa drugs; or if||
0520|131|P|you have any other allergies. This product may contain inactive||
0520|132|P|ingredients, which can cause allergic reactions or other||
0520|133|P|problems. Talk to your pharmacist for more details.||
0520|134|P|   Before using this medication, tell your doctor or pharmacist||
0520|135|P|your medical history, especially of: diabetes, heart problems||
0520|136|P|(coronary artery disease, heart attack), blood or bleeding||
0520|137|P|disorders (such as hemophilia), other conditions causing an||
0520|138|P|increased risk of bleeding (such as injury, surgery), high blood||
0520|139|P|fat levels (cholesterol/triglyceride), other viral infections||
0520|140|P|(chronic hepatitis B or hepatitis C), liver disease (including||
0520|141|P|abnormal liver function tests).||
0520|142|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0520|143|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0520|144|P|machinery, or do anything that needs alertness until you can do||
0520|145|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0520|146|P|are using marijuana (cannabis).||
0520|147|P|   This drug may rarely make your blood sugar rise, which can||
0520|148|P|cause or worsen diabetes. If you already have diabetes, check||
0520|149|P|your blood sugar regularly as directed and share the results with||
0520|150|P|your doctor. Tell your doctor right away if you have symptoms of||
0520|151|P|high blood sugar such as increased thirst/urination. Your doctor||
0520|152|P|may need to adjust your diabetes medication, exercise program, or||
0520|153|P|diet.||
0520|154|P|   Before having surgery, tell your doctor or dentist about all||
0520|155|P|the products you use (including prescription drugs,||
0520|156|P|nonprescription drugs, and herbal products).||
0520|157|P|   This medication may make you more sensitive to the sun. Limit||
0520|158|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0520|159|P|sunscreen and wear protective clothing when outdoors. Tell your||
0520|160|P|doctor right away if you get sunburned or have skin||
0520|161|P|blisters/redness.||
0520|162|P|   During pregnancy, this medication should be used only when||
0520|163|P|clearly needed. Treatment can lower the risk of passing HIV||
0520|164|P|infection to your baby, and tipranavir may be part of that||
0520|165|P|treatment. Discuss the risks and benefits with your doctor.||
0520|166|P|   It is unknown if this medication passes into breast milk.||
0520|167|P|Because breast milk may transmit HIV, consult your doctor before||
0520|168|P|breastfeeding.||
0520|169|B|||
0520|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0520|171|I|medications work or increase your risk for serious side effects.||
0520|172|I|This document does not contain all possible drug interactions.||
0520|173|I|Keep a list of all the products you use (including||
0520|174|I|prescription/nonprescription drugs and herbal products) and share||
0520|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
0520|176|I|the dosage of any medicines without your doctor's approval.||
0520|177|I|   Some products that may interact with this drug include:||
0520|178|I|antiplatelet drugs (such as clopidogrel), artemether, "blood||
0520|179|I|thinners" (anticoagulants such as warfarin, heparins), NSAIDs||
0520|180|I|(such as ibuprofen, naproxen, sulindac, indomethacin),||
0520|181|I|disulfiram, estrogens (such as ethinyl estradiol), garlic||
0520|182|I|supplements, vitamin E, lumefantrine, metronidazole, orlistat.||
0520|183|I|   Other medications can affect the removal of tipranavir from||
0520|184|I|your body, which may affect how tipranavir works. Examples||
0520|185|I|include apalutamide, macrolide antibiotics (such as||
0520|186|I|erythromycin), rifampin, St. John's wort, drugs used to treat||
0520|187|I|seizures (such as carbamazepine, phenytoin), among others.||
0520|188|I|   Tipranavir with ritonavir can both speed up and slow down the||
0520|189|I|removal of other drugs from your body, thereby affecting how they||
0520|190|I|work. Examples of affected drugs include alfuzosin, certain||
0520|191|I|benzodiazepines (such as midazolam, triazolam), certain heart||
0520|192|I|rhythm drugs (amiodarone, bepridil, flecainide, propafenone,||
0520|193|I|quinidine), colchicine, eletriptan, eplerenone, ergot-containing||
0520|194|I|drugs (such as ergotamine), fluticasone, other HIV medications||
0520|195|I|(such as etravirine, other protease inhibitors including||
0520|196|I|fosamprenavir, lopinavir), meperidine, pimozide, ranolazine,||
0520|197|I|salmeterol, certain "statin" cholesterol drugs (such as||
0520|198|I|atorvastatin, lovastatin, simvastatin), drugs to treat erectile||
0520|199|I|dysfunction-ED or pulmonary hypertension (such as sildenafil,||
0520|200|I|vardenafil), among others.||
0520|201|I|   Aspirin can increase the risk of bleeding when used with this||
0520|202|I|medication. However, if your doctor has told you to take low-dose||
0520|203|I|aspirin to prevent heart attack or stroke (usually 81-162||
0520|204|I|milligrams a day), you should keep taking the aspirin unless your||
0520|205|I|doctor tells you not to. Ask your doctor or pharmacist for more||
0520|206|I|details.||
0520|207|I|   This medication may decrease the effectiveness of hormonal||
0520|208|I|birth control such as pills, patch, or ring. This could cause||
0520|209|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0520|210|I|use reliable backup birth control methods while using this||
0520|211|I|medication. Also tell your doctor if you have any new spotting or||
0520|212|I|breakthrough bleeding, because these may be signs that your birth||
0520|213|I|control is not working well.||
0520|214|B|||
0520|215|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0520|216|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0520|217|O|poison control center right away. US residents can call||
0520|218|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0520|219|B|||
0520|220|N|NOTES:  Do not share this medication with others.||
0520|221|N|   Lab and/or medical tests (such as liver function, HIV RNA||
0520|222|N|levels, blood sugar, blood counts, blood cholesterol/triglyceride||
0520|223|N|levels) should be done while you are taking this medication. Keep||
0520|224|N|all medical and lab appointments. Consult your doctor for more||
0520|225|N|details.||
0520|226|B|||
0520|227|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0520|228|D|remember. If it is near the time of the next dose, skip the||
0520|229|D|missed dose. Take your next dose at the regular time. Do not||
0520|230|D|double the dose to catch up.||
0520|231|B|||
0520|232|R|STORAGE:  Store unopened bottles in the refrigerator. After||
0520|233|R|opening the bottle, the capsules may be stored at room||
0520|234|R|temperature away from light and moisture. Do not store in the||
0520|235|R|bathroom. Once the bottle is opened, this medication expires||
0520|236|R|after 60 days. Keep all medications away from children and pets.||
0520|237|R|   Do not flush medications down the toilet or pour them into a||
0520|238|R|drain unless instructed to do so. Properly discard this product||
0520|239|R|when it is expired or no longer needed. Consult your pharmacist||
0520|240|R|or local waste disposal company.||
0520|241|B|||
0520|242|A|Information last revised April 2025.||
0520|243|A|Copyright(c) 2025 First Databank, Inc.||
0520|244|B|||
0521|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0521|002|Z|does NOT have all possible information about this product. This||
0521|003|Z|information does not assure that this product is safe, effective,||
0521|004|Z|or appropriate for you. This information is not individual||
0521|005|Z|medical advice and does not substitute for the advice of your||
0521|006|Z|health care professional. Always ask your health care||
0521|007|Z|professional for complete information about this product and your||
0521|008|Z|specific health needs.||
0521|009|B|||
0521|010|T|MEGESTROL CONCENTRATED SUSPENSION - ORAL||
0521|011|F|(me-JES-trol)||
0521|012|B|||
0521|013|C|COMMON BRAND NAME(S): Megace ES||
0521|014|B|||
0521|015|U|USES:  Megestrol is used to treat loss of appetite and weight||
0521|016|U|loss in people with AIDS. Improving your appetite and gaining||
0521|017|U|weight may help you feel better and be more active.||
0521|018|U|   Megestrol is similar to a natural substance made by the body||
0521|019|U|called progesterone.||
0521|020|B|||
0521|021|V|OTHER USES:  This section contains uses of this drug that are not||
0521|022|V|listed in the approved professional labeling for the drug but||
0521|023|V|that may be prescribed by your health care professional. Use this||
0521|024|V|drug for a condition that is listed in this section only if it||
0521|025|V|has been so prescribed by your health care professional.||
0521|026|V|   This drug may also be used to counter unhealthy weight loss in||
0521|027|V|people with certain cancers by improving their appetite. It may||
0521|028|V|also be used for cancer of the breast, uterus, ovaries, or||
0521|029|V|prostate.||
0521|030|B|||
0521|031|H|HOW TO USE:  Take this medication by mouth with or without food||
0521|032|H|as directed by your doctor, usually once daily. Shake the bottle||
0521|033|H|well before each dose. Carefully measure the dose using a special||
0521|034|H|measuring device/spoon. Do not use a household spoon because you||
0521|035|H|may not get the correct dose.||
0521|036|H|   This medication is a high-strength concentrated liquid||
0521|037|H|product. Do not switch between different liquid forms of||
0521|038|H|megestrol because you may not get the correct dose.||
0521|039|H|   The dosage is based on your medical condition and response to||
0521|040|H|treatment.||
0521|041|H|   Use this medication regularly to get the most benefit from it.||
0521|042|H|To help you remember, take it at the same time each day.||
0521|043|H|   Do not increase your dose or use this drug more often or for||
0521|044|H|longer than prescribed. Your condition will not improve any||
0521|045|H|faster, and your risk of side effects will increase.||
0521|046|H|   Since this drug can be absorbed through the skin and may harm||
0521|047|H|an unborn baby, women who are pregnant or who may become pregnant||
0521|048|H|should handle this medication carefully. Wash your skin well||
0521|049|H|right away if megestrol gets on your skin.||
0521|050|H|   It may take up to several weeks before you get the full||
0521|051|H|benefit of this drug.||
0521|052|H|   Tell your doctor if you do not get better or if you get worse.||
0521|053|B|||
0521|054|S|SIDE EFFECTS:  Trouble sleeping, fever, gas, decreased sexual||
0521|055|S|ability/desire, or upset stomach may occur. Women may have||
0521|056|S|changes in their menstrual periods, such as unpredictable||
0521|057|S|bleeding. If any of these effects last or get worse, tell your||
0521|058|S|doctor or pharmacist promptly.||
0521|059|S|   Remember that this medication has been prescribed because your||
0521|060|S|doctor has judged that the benefit to you is greater than the||
0521|061|S|risk of side effects. Many people using this medication do not||
0521|062|S|have serious side effects.||
0521|063|S|   Tell your doctor right away if you have any serious side||
0521|064|S|effects, including: fast/pounding heartbeat, tiredness, headache,||
0521|065|S|swelling of the hands/feet.||
0521|066|S|   This medication may rarely make your blood sugar rise, which||
0521|067|S|can cause or worsen diabetes. Tell your doctor right away if you||
0521|068|S|have symptoms of high blood sugar such as increased||
0521|069|S|thirst/urination. If you already have diabetes, check your blood||
0521|070|S|sugar regularly as directed and share the results with your||
0521|071|S|doctor. Your doctor may need to adjust your diabetes medication,||
0521|072|S|exercise program, or diet.||
0521|073|S|   Get medical help right away if you have any very serious side||
0521|074|S|effects, including: symptoms of a blood clot (such as chest pain,||
0521|075|S|trouble breathing, pain/redness/swelling of arms or legs),||
0521|076|S|confusion, mental/mood changes, weakness/numbness on one side of||
0521|077|S|the body, trouble speaking, vision changes.||
0521|078|S|   A very serious allergic reaction to this drug is rare.||
0521|079|S|However, get medical help right away if you notice any symptoms||
0521|080|S|of a serious allergic reaction, including: rash, itching/swelling||
0521|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0521|082|S|breathing.||
0521|083|S|   This is not a complete list of possible side effects. If you||
0521|084|S|notice other effects not listed above, contact your doctor or||
0521|085|S|pharmacist.||
0521|086|S|   In the US -||
0521|087|S|   Call your doctor for medical advice about side effects. You||
0521|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0521|089|S|www.fda.gov/medwatch.||
0521|090|S|   In Canada - Call your doctor for medical advice about side||
0521|091|S|effects. You may report side effects to Health Canada at||
0521|092|S|1-866-234-2345.||
0521|093|B|||
0521|094|P|PRECAUTIONS:  Before taking megestrol, tell your doctor or||
0521|095|P|pharmacist if you are allergic to it; or if you have any other||
0521|096|P|allergies. This product may contain inactive ingredients, which||
0521|097|P|can cause allergic reactions or other problems. Talk to your||
0521|098|P|pharmacist for more details.||
0521|099|P|   Before using this medication, tell your doctor or pharmacist||
0521|100|P|your medical history, especially of: adrenal gland problems (such||
0521|101|P|as Cushing's syndrome), blood clots, diabetes, heart disease||
0521|102|P|(such as heart failure), high blood pressure, kidney disease,||
0521|103|P|stomach or abdominal problems, unusual vaginal bleeding.||
0521|104|P|   If you have diabetes, this product may affect your blood||
0521|105|P|sugar. Check your blood sugar regularly as directed and share the||
0521|106|P|results with your doctor. Tell your doctor right away if you have||
0521|107|P|symptoms of high blood sugar (see Side Effects section). Your||
0521|108|P|doctor may need to adjust your diabetes medication, exercise||
0521|109|P|program, or diet.||
0521|110|P|   Using megestrol for a long time may make it more difficult for||
0521|111|P|your body to respond to physical stress. Before having surgery or||
0521|112|P|emergency treatment, or if you get a serious illness/injury, tell||
0521|113|P|your doctor or dentist that you are using this medication or have||
0521|114|P|recently stopped taking it. Tell your doctor right away if you||
0521|115|P|develop unusual/extreme tiredness, dizziness, nausea, or||
0521|116|P|vomiting.||
0521|117|P|   Older adults may be more sensitive to the side effects of this||
0521|118|P|drug, especially the risk for blood clots.||
0521|119|P|   This medication must not be used during pregnancy. It may harm||
0521|120|P|an unborn baby. Your doctor should order a pregnancy test before||
0521|121|P|you start this medication. Discuss the use of reliable forms of||
0521|122|P|birth control (such as condoms, birth control pills) with your||
0521|123|P|doctor. If you become pregnant or think you may be pregnant, tell||
0521|124|P|your doctor right away.||
0521|125|P|   This medication passes into breast milk. Because of the||
0521|126|P|possible risk to the infant, breastfeeding is not recommended||
0521|127|P|while using this medication. Consult your doctor before||
0521|128|P|breastfeeding.||
0521|129|B|||
0521|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0521|131|I|medications work or increase your risk for serious side effects.||
0521|132|I|This document does not contain all possible drug interactions.||
0521|133|I|Keep a list of all the products you use (including||
0521|134|I|prescription/nonprescription drugs and herbal products) and share||
0521|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
0521|136|I|the dosage of any medicines without your doctor's approval.||
0521|137|I|   A product that may interact with this drug is: dofetilide.||
0521|138|B|||
0521|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0521|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0521|141|O|poison control center right away. US residents can call||
0521|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0521|143|B|||
0521|144|N|NOTES:  Do not share this medication with others.||
0521|145|N|   Lab and/or medical tests (such as blood pressure, blood sugar)||
0521|146|N|may be done while you are taking this medication. Keep all||
0521|147|N|medical and lab appointments. Consult your doctor for more||
0521|148|N|details.||
0521|149|B|||
0521|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0521|151|D|remember. If it is near the time of the next dose, skip the||
0521|152|D|missed dose. Take your next dose at the regular time. Do not||
0521|153|D|double the dose to catch up.||
0521|154|B|||
0521|155|R|STORAGE:  Store at room temperature away from heat. Keep all||
0521|156|R|medications away from children and pets.||
0521|157|R|   Do not flush medications down the toilet or pour them into a||
0521|158|R|drain unless instructed to do so. Properly discard this product||
0521|159|R|when it is expired or no longer needed. Consult your pharmacist||
0521|160|R|or local waste disposal company.||
0521|161|B|||
0521|162|A|Information last revised October 2024.||
0521|163|A|Copyright(c) 2025 First Databank, Inc.||
0521|164|B|||
0522|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0522|002|Z|does NOT have all possible information about this product. This||
0522|003|Z|information does not assure that this product is safe, effective,||
0522|004|Z|or appropriate for you. This information is not individual||
0522|005|Z|medical advice and does not substitute for the advice of your||
0522|006|Z|health care professional. Always ask your health care||
0522|007|Z|professional for complete information about this product and your||
0522|008|Z|specific health needs.||
0522|009|B|||
0522|010|T|GANIRELIX ACETATE PREFILLED SYRINGE - INJECTION||
0522|011|F|(GAN-i-REL-ix AS-e-tate)||
0522|012|B|||
0522|013|C|COMMON BRAND NAME(S): Antagon||
0522|014|B|||
0522|015|U|USES:  This medication is used by women having certain fertility||
0522|016|U|treatments (controlled ovarian stimulation). Ganirelix is usually||
0522|017|U|used in combination with other hormones (FSH and hCG). It works||
0522|018|U|by blocking the release of a certain hormone (luteinizing||
0522|019|U|hormone). Ganirelix stops eggs from being released too early and||
0522|020|U|gives the eggs time to grow properly.||
0522|021|B|||
0522|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0522|023|H|from your pharmacist before you start using ganirelix and each||
0522|024|H|time you get a refill. Ask your health care professional how to||
0522|025|H|prepare and use this medication. If you have any questions, ask||
0522|026|H|your doctor or pharmacist.||
0522|027|H|   Inject this medication under the skin as directed by your||
0522|028|H|doctor, usually once a day for several days. Carefully follow||
0522|029|H|your doctor's instructions on when to start and stop this||
0522|030|H|medication. The injection is given in the abdomen or thighs.||
0522|031|H|   Before using, check this product for particles or||
0522|032|H|discoloration. If either is present, do not use the liquid.||
0522|033|H|Before injecting each dose, clean the skin you are going to||
0522|034|H|inject into (the injection site) with rubbing alcohol. Change the||
0522|035|H|injection site each time to lessen injury under the skin. To||
0522|036|H|lessen bruising, do not rub the injection site after a shot.||
0522|037|H|Learn how to store and discard medical supplies safely.||
0522|038|H|   Use this medication exactly as directed by your doctor to get||
0522|039|H|the most benefit from it. Do not increase your dose or use this||
0522|040|H|drug more often or for longer than prescribed.||
0522|041|B|||
0522|042|S|SIDE EFFECTS:  Redness or pain at the injection site, headache,||
0522|043|S|mild nausea/stomach pain, or tiredness may occur. If any of these||
0522|044|S|effects last or get worse, tell your doctor or pharmacist||
0522|045|S|promptly.||
0522|046|S|   Remember that this medication has been prescribed because your||
0522|047|S|doctor has judged that the benefit to you is greater than the||
0522|048|S|risk of side effects. Many people using this medication do not||
0522|049|S|have serious side effects.||
0522|050|S|   Tell your doctor right away if you have any serious side||
0522|051|S|effects, such as: unusual vaginal bleeding.||
0522|052|S|   This medication may cause a condition known as ovarian||
0522|053|S|hyperstimulation syndrome (OHSS). This condition may occur during||
0522|054|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
0522|055|S|build up in the stomach, chest, and heart area. Get medical help||
0522|056|S|right away if you develop the following side effects: severe pain||
0522|057|S|or swelling in the lower abdominal (pelvic) area, severe||
0522|058|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
0522|059|S|urination.||
0522|060|S|   A very serious allergic reaction to this drug is rare.||
0522|061|S|However, get medical help right away if you notice any symptoms||
0522|062|S|of a serious allergic reaction, such as: rash, itching/swelling||
0522|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0522|064|S|breathing.||
0522|065|S|   This is not a complete list of possible side effects. If you||
0522|066|S|notice other effects not listed above, contact your doctor or||
0522|067|S|pharmacist.||
0522|068|S|   In the US -||
0522|069|S|   Call your doctor for medical advice about side effects. You||
0522|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0522|071|S|www.fda.gov/medwatch.||
0522|072|S|   In Canada - Call your doctor for medical advice about side||
0522|073|S|effects. You may report side effects to Health Canada at||
0522|074|S|1-866-234-2345.||
0522|075|B|||
0522|076|P|PRECAUTIONS:  Before using ganirelix, tell your doctor or||
0522|077|P|pharmacist if you are allergic to it; or to other products||
0522|078|P|containing gonadotropin releasing hormone (GnRH); or if you have||
0522|079|P|any other allergies. This product may contain inactive||
0522|080|P|ingredients (such as latex), which can cause allergic reactions||
0522|081|P|or other problems. Talk to your pharmacist for more details.||
0522|082|P|   Before using this medication, tell your doctor or pharmacist||
0522|083|P|your medical history.||
0522|084|P|   Before having surgery, tell your doctor or dentist about all||
0522|085|P|the products you use (such as prescription drugs, nonprescription||
0522|086|P|drugs, and herbal products).||
0522|087|P|   Multiple births may occur as a result of this treatment.||
0522|088|P|Consult your doctor for more details.||
0522|089|P|   Stop using this medication when you become pregnant. This||
0522|090|P|medication must not be used during pregnancy. If you think you||
0522|091|P|may be pregnant, tell your doctor right away.||
0522|092|P|   It is unknown if this drug passes into breast milk. Because of||
0522|093|P|the possible risk to the infant, breastfeeding is not recommended||
0522|094|P|while using this drug. Consult your doctor before breastfeeding.||
0522|095|B|||
0522|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0522|097|I|medications work or increase your risk for serious side effects.||
0522|098|I|This document does not contain all possible drug interactions.||
0522|099|I|Keep a list of all the products you use (such as||
0522|100|I|prescription/nonprescription drugs and herbal products) and share||
0522|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0522|102|I|the dosage of any medicines without your doctor's approval.||
0522|103|B|||
0522|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0522|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0522|106|O|poison control center right away. US residents can call||
0522|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0522|108|B|||
0522|109|N|NOTES:  Do not share this medication with others.||
0522|110|N|   Lab and/or medical tests (such as vaginal ultrasound, hormone||
0522|111|N|levels, liver tests) may be done while you are using this||
0522|112|N|medication. Keep all medical and lab appointments. Consult your||
0522|113|N|doctor for more details.||
0522|114|B|||
0522|115|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
0522|116|D|right away for a new dosing schedule. Do not double the dose to||
0522|117|D|catch up.||
0522|118|B|||
0522|119|R|STORAGE:  Store at room temperature away from light. Discard any||
0522|120|R|unused portion after use. Keep all medications away from children||
0522|121|R|and pets.||
0522|122|R|   Do not flush medications down the toilet or pour them into a||
0522|123|R|drain unless instructed to do so. Properly discard this product||
0522|124|R|when it is expired or no longer needed. Consult your pharmacist||
0522|125|R|or local waste disposal company.||
0522|126|B|||
0522|127|A|Information last revised December 2024.||
0522|128|A|Copyright(c) 2025 First Databank, Inc.||
0522|129|B|||
0523|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0523|002|Z|does NOT have all possible information about this product. This||
0523|003|Z|information does not assure that this product is safe, effective,||
0523|004|Z|or appropriate for you. This information is not individual||
0523|005|Z|medical advice and does not substitute for the advice of your||
0523|006|Z|health care professional. Always ask your health care||
0523|007|Z|professional for complete information about this product and your||
0523|008|Z|specific health needs.||
0523|009|B|||
0523|010|T|ASPIRIN/ACETAMINOPHEN/CAFFEINE - ORAL||
0523|011|F|(AS-pir-in/a-SEET-a-MIN-oh-fen/KAF-een)||
0523|012|B|||
0523|013|C|COMMON BRAND NAME(S): Excedrin, Genaced||
0523|014|B|||
0523|015|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
0523|016|W|too much acetaminophen may cause serious (possibly fatal) liver||
0523|017|W|disease. Adults should not take more than 4000 milligrams (4||
0523|018|W|grams) of acetaminophen a day. People with liver problems and||
0523|019|W|children should take less acetaminophen. Ask your doctor or||
0523|020|W|pharmacist how much acetaminophen is safe to take.||
0523|021|W|   Do not use with any other drug containing acetaminophen||
0523|022|W|without asking your doctor or pharmacist first. Acetaminophen is||
0523|023|W|in many nonprescription and prescription medications (such as||
0523|024|W|pain/fever drugs or cough-and-cold products). Check the labels on||
0523|025|W|all your medicines to see if they contain acetaminophen, and ask||
0523|026|W|your pharmacist if you are unsure.||
0523|027|W|   Get medical help right away if you take too much acetaminophen||
0523|028|W|(overdose), even if you feel well. Overdose symptoms may include||
0523|029|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
0523|030|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
0523|031|W|   Daily alcohol use, especially when combined with||
0523|032|W|acetaminophen, may damage your liver. Avoid alcohol.||
0523|033|B|||
0523|034|U|USES:  This product is a combination of aspirin, acetaminophen,||
0523|035|U|and caffeine. It is used for the temporary relief of pain from||
0523|036|U|conditions such as muscle aches, toothaches, menstrual cramps, or||
0523|037|U|headaches (including migraine). Aspirin and acetaminophen relieve||
0523|038|U|pain by keeping your body from making certain natural substances.||
0523|039|U|Caffeine helps increase the effects of aspirin and acetaminophen.||
0523|040|B|||
0523|041|H|HOW TO USE:  See also Warning section.||
0523|042|H|   If you are taking the over-the-counter product to self-treat,||
0523|043|H|read all directions on the product package before taking this||
0523|044|H|medication. If you have any questions, consult your pharmacist.||
0523|045|H|If your doctor has prescribed this medication, take it as||
0523|046|H|directed.||
0523|047|H|   Take this medication by mouth as directed by your doctor, or||
0523|048|H|follow the product package directions. Drink a full glass of||
0523|049|H|water (8 ounces/240 milliliters) with this medication unless your||
0523|050|H|doctor directs you otherwise. If you are using the tablet form of||
0523|051|H|this medication, do not lie down for at least 10 minutes after||
0523|052|H|you have taken this drug. If upset stomach occurs, you may take||
0523|053|H|it with food or milk.||
0523|054|H|   The dosage is based on your medical condition and response to||
0523|055|H|treatment. Do not increase your dose or use this drug more often||
0523|056|H|or for longer than directed. Do not use this product for pain||
0523|057|H|lasting longer than 10 days or fever lasting more than 3 days.||
0523|058|H|Use the smallest effective dose. Consult your doctor or||
0523|059|H|pharmacist for more information.||
0523|060|H|   If you are taking this drug "as needed" (not on a regular||
0523|061|H|schedule), remember that pain medications work best if they are||
0523|062|H|used as the first signs of pain occur. If you wait until the pain||
0523|063|H|has worsened, the medication may not work as well.||
0523|064|H|   If you are taking this product for headache, get medical help||
0523|065|H|right away if you also have: trouble speaking, weakness on one||
0523|066|H|side of the body, sudden vision changes. Before using this||
0523|067|H|product, consult a doctor or pharmacist if you have: daily||
0523|068|H|headaches; your first headache after age 50; a headache that is||
0523|069|H|more severe or different from your usual headaches; headaches||
0523|070|H|caused by head injury, coughing or bending; a headache with||
0523|071|H|vomiting, fever and stiff neck. Consult your doctor or pharmacist||
0523|072|H|if your migraine headache is not relieved, or if it worsens after||
0523|073|H|the first dose.||
0523|074|H|   If you are using drugs for migraine attacks on 10 or more days||
0523|075|H|each month, the drugs may actually make your headaches worse||
0523|076|H|(medication overuse headache). Do not use medications more often||
0523|077|H|or for longer than directed. Tell your doctor if you need to use||
0523|078|H|this medication more often, or if the medication is not working||
0523|079|H|as well, or if your headaches get worse.||
0523|080|H|   Consult your doctor if your condition lasts or gets worse (for||
0523|081|H|example, if you have new or unusual symptoms, redness or swelling||
0523|082|H|of the painful area, pain or fever that does not go away or gets||
0523|083|H|worse).||
0523|084|B|||
0523|085|S|SIDE EFFECTS:  See also Warning section.||
0523|086|S|   Nausea, vomiting, stomach upset, trouble falling asleep, or a||
0523|087|S|shaky/nervous feeling may occur. If any of these effects last or||
0523|088|S|get worse, notify your doctor or pharmacist promptly.||
0523|089|S|   If your doctor has directed you to use this medication,||
0523|090|S|remember that your doctor has judged that the benefit to you is||
0523|091|S|greater than the risk of side effects. Many people using this||
0523|092|S|medication do not have serious side effects.||
0523|093|S|   Stop taking this medication and tell your doctor right away if||
0523|094|S|you have any serious side effects, including: stomach/abdominal||
0523|095|S|pain that is severe or doesn't go away, severe dizziness,||
0523|096|S|fainting, vomit that looks like coffee grounds, black/bloody||
0523|097|S|stools, ringing in the ears, loss of hearing, irregular/fast||
0523|098|S|heartbeat, signs of kidney problems (such as change in the amount||
0523|099|S|of urine), easy bruising/bleeding.||
0523|100|S|   A very serious allergic reaction to this drug is rare.||
0523|101|S|However, get medical help right away if you notice any symptoms||
0523|102|S|of a serious allergic reaction, including: fever, swollen lymph||
0523|103|S|nodes, rash, itching/swelling (especially of the||
0523|104|S|face/tongue/throat), severe dizziness, trouble breathing.||
0523|105|S|   This is not a complete list of possible side effects. If you||
0523|106|S|notice other effects not listed above, contact your doctor or||
0523|107|S|pharmacist.||
0523|108|S|   In the US -||
0523|109|S|   Call your doctor for medical advice about side effects. You||
0523|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0523|111|S|www.fda.gov/medwatch.||
0523|112|S|   In Canada - Call your doctor for medical advice about side||
0523|113|S|effects. You may report side effects to Health Canada at||
0523|114|S|1-866-234-2345.||
0523|115|B|||
0523|116|P|PRECAUTIONS:  See also Warning section.||
0523|117|P|   Before taking this product, tell your doctor or pharmacist if||
0523|118|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
0523|119|P|ibuprofen, naproxen, celecoxib); or to other salicylates (such as||
0523|120|P|choline salicylate); or to acetaminophen; or to caffeine; or if||
0523|121|P|you have any other allergies. This product may contain inactive||
0523|122|P|ingredients, which can cause allergic reactions or other||
0523|123|P|problems. Talk to your pharmacist for more details.||
0523|124|P|   Before using this medication, tell your doctor or pharmacist||
0523|125|P|your medical history, especially of: asthma (including a history||
0523|126|P|of worsening breathing with runny/stuffy nose after taking||
0523|127|P|aspirin or other NSAIDs such as ibuprofen, naproxen), certain||
0523|128|P|blood disorders (such as anemia), bleeding or blood clotting||
0523|129|P|problems (such as hemophilia, low platelet count), ulcers, gout,||
0523|130|P|kidney or liver disease, growths in the nose (nasal polyps),||
0523|131|P|anxiety disorders, insomnia, heart disease (such as arrhythmia),||
0523|132|P|high blood pressure, stomach problems (such as heartburn, upset||
0523|133|P|stomach, or stomach pain).||
0523|134|P|   Before having surgery or certain medical procedures (such as a||
0523|135|P|heart stress test or a procedure to restore a normal heart rhythm||
0523|136|P|if you have an unusually fast heartbeat), tell your doctor or||
0523|137|P|dentist that you use this medication and about all the products||
0523|138|P|you use (including prescription drugs, nonprescription drugs, and||
0523|139|P|herbal products).||
0523|140|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0523|141|P|and tobacco, especially when combined with this medicine, may||
0523|142|P|increase your risk for stomach bleeding. Avoid alcohol and stop||
0523|143|P|smoking. Consult your doctor or pharmacist for more information.||
0523|144|P|   Older adults may be more sensitive to the side effects of this||
0523|145|P|drug, especially stomach/intestinal bleeding and ulcers, liver||
0523|146|P|problems, and trouble falling asleep.||
0523|147|P|   Children and teenagers less than 18 years old should not use||
0523|148|P|aspirin, aspirin-containing or aspirin-related medications such||
0523|149|P|as this product for flu symptoms or chickenpox without first||
0523|150|P|consulting a doctor. A rare but serious illness known as Reye's||
0523|151|P|syndrome may occur. Tell your doctor right away if you notice||
0523|152|P|changes in behavior with nausea and vomiting.||
0523|153|P|   Before using this medication, women of childbearing age should||
0523|154|P|talk with their doctor(s) about the benefits and risks. Tell your||
0523|155|P|doctor if you are pregnant or if you plan to become pregnant.||
0523|156|P|This medication may harm an unborn baby and cause problems with||
0523|157|P|normal labor/delivery. It is not recommended for use in pregnancy||
0523|158|P|from 20 weeks until delivery. If your doctor decides that you||
0523|159|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0523|160|P|you should use the lowest effective dose for the shortest||
0523|161|P|possible time. You should not use this medication after 30 weeks||
0523|162|P|of pregnancy.||
0523|163|P|   This product passes into breast milk and may have undesirable||
0523|164|P|effects on a nursing infant. Consult your doctor before||
0523|165|P|breastfeeding.||
0523|166|B|||
0523|167|I|DRUG INTERACTIONS:  See also Warning section.||
0523|168|I|   Drug interactions may change how your medications work or||
0523|169|I|increase your risk for serious side effects. This document does||
0523|170|I|not contain all possible drug interactions. Keep a list of all||
0523|171|I|the products you use (including prescription/nonprescription||
0523|172|I|drugs and herbal products) and share it with your doctor and||
0523|173|I|pharmacist. Do not start, stop, or change the dosage of any||
0523|174|I|medicines without your doctor's approval.||
0523|175|I|   Some products that may interact with this drug are:||
0523|176|I|acetazolamide, cimetidine, corticosteroids (such as prednisone),||
0523|177|I|dichlorphenamide, ketoconazole, levoketoconazole, methotrexate,||
0523|178|I|mifepristone, certain medications for gout (such as probenecid),||
0523|179|I|anti-seizure drugs (such as phenytoin, valproic acid),||
0523|180|I|vemurafenib.||
0523|181|I|   Consult your doctor before using this product if you have||
0523|182|I|recently received certain live vaccines (such as varicella||
0523|183|I|vaccine, influenza intranasal vaccine).||
0523|184|I|   This medication may increase the risk of bleeding when taken||
0523|185|I|with other drugs that also may cause bleeding. Examples include||
0523|186|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0523|187|I|dabigatran/enoxaparin/warfarin, among others.||
0523|188|I|   Check all prescription and nonprescription medicine labels||
0523|189|I|carefully since many medications contain pain relievers/fever||
0523|190|I|reducers (including acetaminophen, aspirin, NSAIDs such as||
0523|191|I|ibuprofen, ketorolac, naproxen). These drugs are similar to this||
0523|192|I|product and may increase your risk of side effects if taken||
0523|193|I|together. Ask your doctor or pharmacist for more details.||
0523|194|I|   This medication may interfere with certain lab tests (such as||
0523|195|I|urinary sugar tests, dipyridamole-thallium imaging tests),||
0523|196|I|possibly causing false test results. Make sure lab personnel and||
0523|197|I|all your doctors know you use this drug.||
0523|198|B|||
0523|199|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0523|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0523|201|O|poison control center right away. US residents can call||
0523|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0523|203|O|Symptoms of overdose may include nausea, vomiting, loss of||
0523|204|O|appetite, sweating, burning pain in the throat and stomach,||
0523|205|O|stomach/abdominal pain, extreme tiredness, yellowing eyes/skin,||
0523|206|O|ringing in the ears, rapid/shallow breathing, irregular/fast||
0523|207|O|heartbeat, change in the amount of urine, dark urine, confusion,||
0523|208|O|agitation, seizures, loss of consciousness.||
0523|209|B|||
0523|210|N|NOTES:  Do not share this medication with others.||
0523|211|N|   If you use this medication regularly for a long time or at||
0523|212|N|high doses, lab and/or medical tests (such as liver/kidney||
0523|213|N|function) may be done while you are taking this medication. Keep||
0523|214|N|all medical and lab appointments. Consult your doctor for more||
0523|215|N|details.||
0523|216|N|   Because this product contains caffeine, taking it close to||
0523|217|N|bedtime may give you trouble falling asleep. Limit the use of||
0523|218|N|caffeine-containing medications, foods, or beverages while taking||
0523|219|N|this product. If you take too much caffeine, you may become||
0523|220|N|nervous or irritable, have trouble sleeping, or have fast||
0523|221|N|heartbeat.||
0523|222|N|   If you are taking this product for headaches, it is best to||
0523|223|N|avoid certain foods that may trigger your headaches. Lifestyle||
0523|224|N|changes such as stress reduction programs, exercise, and dietary||
0523|225|N|changes may help prevent headaches. Talk to your doctor or||
0523|226|N|pharmacist about lifestyle changes that might benefit you.||
0523|227|B|||
0523|228|D|MISSED DOSE:  If you take this medication regularly and miss a||
0523|229|D|dose, take it as soon as you remember. If it is near the time of||
0523|230|D|the next dose, skip the missed dose. Take your next dose at the||
0523|231|D|regular time. Do not double the dose to catch up.||
0523|232|B|||
0523|233|R|STORAGE:  Store at room temperature away from light and moisture.||
0523|234|R|Do not store in the bathroom. Keep all medications away from||
0523|235|R|children and pets.||
0523|236|R|   Do not flush medications down the toilet or pour them into a||
0523|237|R|drain unless instructed to do so. Properly discard this product||
0523|238|R|when it is expired or no longer needed. Consult your pharmacist||
0523|239|R|or local waste disposal company.||
0523|240|B|||
0523|241|A|Information last revised February 2025.||
0523|242|A|Copyright(c) 2025 First Databank, Inc.||
0523|243|B|||
0524|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0524|002|Z|does NOT have all possible information about this product. This||
0524|003|Z|information does not assure that this product is safe, effective,||
0524|004|Z|or appropriate for you. This information is not individual||
0524|005|Z|medical advice and does not substitute for the advice of your||
0524|006|Z|health care professional. Always ask your health care||
0524|007|Z|professional for complete information about this product and your||
0524|008|Z|specific health needs.||
0524|009|B|||
0524|010|T|AMPICILLIN - INJECTION||
0524|011|F|(AM-pi-SIL-in)||
0524|012|B|||
0524|013|C|COMMON BRAND NAME(S): Omnipen-N||
0524|014|B|||
0524|015|U|USES:  Ampicillin is used to treat a wide variety of bacterial||
0524|016|U|infections. It is a penicillin-type antibiotic. It works by||
0524|017|U|stopping the growth of bacteria.||
0524|018|B|||
0524|019|H|HOW TO USE:  This medication is given by injection into a vein or||
0524|020|H|into a muscle by a healthcare professional as directed by your||
0524|021|H|doctor. The dosage is based on your weight, medical condition,||
0524|022|H|and response to treatment.||
0524|023|H|   If you are using this medication at home, learn all||
0524|024|H|preparation and usage instructions from your healthcare||
0524|025|H|professional. Before using, check this product for particles or||
0524|026|H|discoloration. If either is present, do not use the liquid. Learn||
0524|027|H|how to store and discard medical supplies safely.||
0524|028|H|   For the best effect, use this antibiotic at evenly spaced||
0524|029|H|times. To help you remember, use this medication at the same||
0524|030|H|time(s) every day.||
0524|031|H|   Continue to use this medication until the full prescribed||
0524|032|H|amount is finished, even if symptoms disappear after a few days.||
0524|033|H|Stopping the medication too early may result in a return of the||
0524|034|H|infection.||
0524|035|H|   Tell your doctor if your condition lasts or gets worse.||
0524|036|B|||
0524|037|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. If any of||
0524|038|S|these effects last or get worse, tell your doctor or pharmacist||
0524|039|S|promptly.||
0524|040|S|   Remember that this medication has been prescribed because your||
0524|041|S|doctor has judged that the benefit to you is greater than the||
0524|042|S|risk of side effects. Many people using this medication do not||
0524|043|S|have serious side effects.||
0524|044|S|   Tell your doctor right away if you have any serious side||
0524|045|S|effects, including: easy bruising or bleeding, signs of liver||
0524|046|S|disease (such as nausea/vomiting that doesn't stop, loss of||
0524|047|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0524|048|S|urine).||
0524|049|S|   This medication may rarely cause a severe intestinal condition||
0524|050|S|due to a bacteria called C. difficile. This condition may occur||
0524|051|S|during treatment or weeks to months after treatment has stopped.||
0524|052|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0524|053|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0524|054|S|stool.||
0524|055|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0524|056|S|products because they may make symptoms worse.||
0524|057|S|   Use of this medication for prolonged or repeated periods may||
0524|058|S|result in oral thrush or a new vaginal yeast infection (oral or||
0524|059|S|vaginal fungal infection). Contact your doctor if you notice||
0524|060|S|white patches in your mouth, a change in vaginal discharge or||
0524|061|S|other new symptoms.||
0524|062|S|   A very serious allergic reaction to this drug is rare.||
0524|063|S|However, get medical help right away if you notice any symptoms||
0524|064|S|of a serious allergic reaction, including: fever that doesn't go||
0524|065|S|away, new or worsening lymph node swelling, rash,||
0524|066|S|itching/swelling (especially of the face/tongue/throat), severe||
0524|067|S|dizziness, trouble breathing.||
0524|068|S|   Ampicillin can commonly cause a mild rash that is usually not||
0524|069|S|serious. However, you may not be able to tell it apart from a||
0524|070|S|rare rash that could be a sign of a severe allergic reaction. Get||
0524|071|S|medical help right away if you develop any rash.||
0524|072|S|   This is not a complete list of possible side effects. If you||
0524|073|S|notice other effects not listed above, contact your doctor or||
0524|074|S|pharmacist.||
0524|075|S|   In the US -||
0524|076|S|   Call your doctor for medical advice about side effects. You||
0524|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0524|078|S|www.fda.gov/medwatch.||
0524|079|S|   In Canada - Call your doctor for medical advice about side||
0524|080|S|effects. You may report side effects to Health Canada at||
0524|081|S|1-866-234-2345.||
0524|082|B|||
0524|083|P|PRECAUTIONS:  Before using ampicillin, tell your doctor or||
0524|084|P|pharmacist if you are allergic to it; or to penicillin or||
0524|085|P|cephalosporin antibiotics; or if you have any other allergies.||
0524|086|P|This product may contain inactive ingredients, which can cause||
0524|087|P|allergic reactions or other problems. Talk to your pharmacist for||
0524|088|P|more details.||
0524|089|P|   Before using this medication, tell your doctor or pharmacist||
0524|090|P|your medical history, especially of: kidney disease, a certain||
0524|091|P|type of viral infection (infectious mononucleosis).||
0524|092|P|   Ampicillin may cause live bacterial vaccines (such as typhoid||
0524|093|P|vaccine) to not work well. Tell your health care professional||
0524|094|P|that you are using ampicillin before having any||
0524|095|P|immunizations/vaccinations.||
0524|096|P|   Older adults may be at greater risk for side effects while||
0524|097|P|using this drug.||
0524|098|P|   During pregnancy, this medication should be used only when||
0524|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
0524|100|P|   Ampicillin passes into breast milk. Consult your doctor before||
0524|101|P|breastfeeding.||
0524|102|B|||
0524|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0524|104|I|medications work or increase your risk for serious side effects.||
0524|105|I|This document does not contain all possible drug interactions.||
0524|106|I|Keep a list of all the products you use (including||
0524|107|I|prescription/nonprescription drugs and herbal products) and share||
0524|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
0524|109|I|the dosage of any medicines without your doctor's approval.||
0524|110|I|   Some products that may interact with this drug include:||
0524|111|I|methotrexate, tetracyclines, warfarin.||
0524|112|I|   This medication may interfere with certain lab tests (such as||
0524|113|I|certain diabetic urine tests), possibly causing false test||
0524|114|I|results. Make sure lab personnel and all your doctors know you||
0524|115|I|use this drug.||
0524|116|B|||
0524|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0524|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0524|119|O|poison control center right away. US residents can call||
0524|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0524|121|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
0524|122|O|severe vomiting, unusual change in the amount of urine, or||
0524|123|O|seizures.||
0524|124|B|||
0524|125|N|NOTES:  If you are using this drug for a long time, lab and/or||
0524|126|N|medical tests (such as kidney/liver function, complete blood||
0524|127|N|count) should be done while you are using this medication. Keep||
0524|128|N|all medical and lab appointments. Consult your doctor for more||
0524|129|N|details.||
0524|130|B|||
0524|131|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0524|132|D|If it is near the time of the next dose, skip the missed dose.||
0524|133|D|Use your next dose at the regular time. Do not double the dose to||
0524|134|D|catch up.||
0524|135|B|||
0524|136|R|STORAGE:  Store vials at room temperature. Store mixed ampicillin||
0524|137|R|bags in the refrigerator. Keep all medications away from children||
0524|138|R|and pets.||
0524|139|R|   Do not flush medications down the toilet or pour them into a||
0524|140|R|drain unless instructed to do so. Properly discard this product||
0524|141|R|when it is expired or no longer needed. Consult your pharmacist||
0524|142|R|or local waste disposal company.||
0524|143|B|||
0524|144|A|Information last revised February 2025.||
0524|145|A|Copyright(c) 2025 First Databank, Inc.||
0524|146|B|||
0525|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0525|002|Z|does NOT have all possible information about this product. This||
0525|003|Z|information does not assure that this product is safe, effective,||
0525|004|Z|or appropriate for you. This information is not individual||
0525|005|Z|medical advice and does not substitute for the advice of your||
0525|006|Z|health care professional. Always ask your health care||
0525|007|Z|professional for complete information about this product and your||
0525|008|Z|specific health needs.||
0525|009|B|||
0525|010|T|DICLOXACILLIN - ORAL||
0525|011|F|(dye-kloks-a-SIL-in)||
0525|012|B|||
0525|013|C|COMMON BRAND NAME(S): Dynapen||
0525|014|B|||
0525|015|U|USES:  Dicloxacillin is used to treat a wide variety of bacterial||
0525|016|U|infections. It is a penicillin-type antibiotic. It works by||
0525|017|U|stopping the growth of bacteria.||
0525|018|U|   This antibiotic treats only bacterial infections. It will not||
0525|019|U|work for viral infections (such as common cold, flu). Using any||
0525|020|U|antibiotic when it is not needed can cause it to not work for||
0525|021|U|future infections.||
0525|022|B|||
0525|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
0525|024|H|doctor, usually 4 times a day (every 6 hours). Take dicloxacillin||
0525|025|H|on an empty stomach (1 hour before or 2 hours after a meal) with||
0525|026|H|a full glass of water. Drink plenty of fluids while using this||
0525|027|H|medication unless your doctor tells you otherwise.||
0525|028|H|   The dosage is based on your medical condition and response to||
0525|029|H|treatment.||
0525|030|H|   For the best effect, take this antibiotic at evenly spaced||
0525|031|H|times. To help you remember, take this medication at the same||
0525|032|H|time(s) every day.||
0525|033|H|   Continue to take this medication until the full prescribed||
0525|034|H|amount is finished even if symptoms disappear after a few days.||
0525|035|H|Stopping the medication too early may result in a return of the||
0525|036|H|infection.||
0525|037|H|   Tell your doctor if your condition lasts or gets worse.||
0525|038|B|||
0525|039|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. If any of||
0525|040|S|these effects last or get worse, tell your doctor or pharmacist||
0525|041|S|promptly.||
0525|042|S|   Remember that this medication has been prescribed because your||
0525|043|S|doctor has judged that the benefit to you is greater than the||
0525|044|S|risk of side effects. Many people using this medication do not||
0525|045|S|have serious side effects.||
0525|046|S|   Tell your doctor right away if you have any serious side||
0525|047|S|effects, including: nausea/vomiting that doesn't stop, sore||
0525|048|S|throat or fever that doesn't go away, dark urine,||
0525|049|S|stomach/abdominal pain, yellowing eyes/skin, easy bruising or||
0525|050|S|bleeding.||
0525|051|S|   This medication may rarely cause a severe intestinal condition||
0525|052|S|due to a bacteria called C. difficile. This condition may occur||
0525|053|S|during treatment or weeks to months after treatment has stopped.||
0525|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0525|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0525|056|S|stool.||
0525|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0525|058|S|products because they may make symptoms worse.||
0525|059|S|   Use of this medication for prolonged or repeated periods may||
0525|060|S|result in oral thrush or a new vaginal yeast infection (oral or||
0525|061|S|vaginal fungal infection). Contact your doctor if you notice||
0525|062|S|white patches in your mouth, a change in vaginal discharge or||
0525|063|S|other new symptoms.||
0525|064|S|   A very serious allergic reaction to this drug is rare.||
0525|065|S|However, get medical help right away if you notice any symptoms||
0525|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0525|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0525|068|S|breathing.||
0525|069|S|   This is not a complete list of possible side effects. If you||
0525|070|S|notice other effects not listed above, contact your doctor or||
0525|071|S|pharmacist.||
0525|072|S|   In the US -||
0525|073|S|   Call your doctor for medical advice about side effects. You||
0525|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0525|075|S|www.fda.gov/medwatch.||
0525|076|S|   In Canada - Call your doctor for medical advice about side||
0525|077|S|effects. You may report side effects to Health Canada at||
0525|078|S|1-866-234-2345.||
0525|079|B|||
0525|080|P|PRECAUTIONS:  Before taking dicloxacillin, tell your doctor or||
0525|081|P|pharmacist if you are allergic to it; or to penicillin or||
0525|082|P|cephalosporin antibiotics; or if you have any other allergies.||
0525|083|P|This product may contain inactive ingredients, which can cause||
0525|084|P|allergic reactions or other problems. Talk to your pharmacist for||
0525|085|P|more details.||
0525|086|P|   Before using this medication, tell your doctor or pharmacist||
0525|087|P|your medical history, especially of: kidney disease.||
0525|088|P|   Dicloxacillin may cause live bacterial vaccines (such as||
0525|089|P|typhoid vaccine) to not work well. Tell your health care||
0525|090|P|professional that you are using dicloxacillin before having any||
0525|091|P|immunizations/vaccinations.||
0525|092|P|   Before having surgery, tell your doctor or dentist about all||
0525|093|P|the products you use (including prescription drugs,||
0525|094|P|nonprescription drugs, and herbal products).||
0525|095|P|   During pregnancy, this medication should be used only when||
0525|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
0525|097|P|   Dicloxacillin passes into breast milk. Consult your doctor||
0525|098|P|before breastfeeding.||
0525|099|B|||
0525|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0525|101|I|medications work or increase your risk for serious side effects.||
0525|102|I|This document does not contain all possible drug interactions.||
0525|103|I|Keep a list of all the products you use (including||
0525|104|I|prescription/nonprescription drugs and herbal products) and share||
0525|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
0525|106|I|the dosage of any medicines without your doctor's approval.||
0525|107|I|   Some of the products that may interact with this drug include:||
0525|108|I|mavacamten, methotrexate, tetracyclines, warfarin.||
0525|109|I|   This medication may interfere with certain lab tests (such as||
0525|110|I|certain diabetic urine tests), possibly causing false test||
0525|111|I|results. Make sure lab personnel and all your doctors know you||
0525|112|I|use this drug.||
0525|113|B|||
0525|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0525|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0525|116|O|poison control center right away. US residents can call||
0525|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0525|118|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
0525|119|O|severe vomiting, unusual change in the amount of urine, or||
0525|120|O|seizures.||
0525|121|B|||
0525|122|N|NOTES:  Do not share this medication with others.||
0525|123|N|   This medication has been prescribed for your current condition||
0525|124|N|only. Do not use it later for another infection unless your||
0525|125|N|doctor tells you to.||
0525|126|N|   If you are using this drug for a long time, lab and/or medical||
0525|127|N|tests (such as kidney/liver function, complete blood count)||
0525|128|N|should be done while you are taking this medication. Keep all||
0525|129|N|medical and lab appointments. Consult your doctor for more||
0525|130|N|details.||
0525|131|B|||
0525|132|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0525|133|D|If it is near the time of the next dose, skip the missed dose.||
0525|134|D|Use your next dose at the regular time. Do not double the dose to||
0525|135|D|catch up.||
0525|136|B|||
0525|137|R|STORAGE:  Store at room temperature away from light and moisture.||
0525|138|R|Do not store in the bathroom. Keep all medications away from||
0525|139|R|children and pets.||
0525|140|R|   Do not flush medications down the toilet or pour them into a||
0525|141|R|drain unless instructed to do so. Properly discard this product||
0525|142|R|when it is expired or no longer needed. Consult your pharmacist||
0525|143|R|or local waste disposal company.||
0525|144|B|||
0525|145|A|Information last revised June 2024.||
0525|146|A|Copyright(c) 2025 First Databank, Inc.||
0525|147|B|||
0526|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0526|002|Z|does NOT have all possible information about this product. This||
0526|003|Z|information does not assure that this product is safe, effective,||
0526|004|Z|or appropriate for you. This information is not individual||
0526|005|Z|medical advice and does not substitute for the advice of your||
0526|006|Z|health care professional. Always ask your health care||
0526|007|Z|professional for complete information about this product and your||
0526|008|Z|specific health needs.||
0526|009|B|||
0526|010|T|MOMETASONE POWDER - ORAL INHALATION||
0526|011|F|(mow-MET-uh-sown)||
0526|012|B|||
0526|013|C|COMMON BRAND NAME(S): Asmanex||
0526|014|B|||
0526|015|U|USES:  Mometasone is used to control and prevent symptoms||
0526|016|U|(wheezing and shortness of breath) caused by asthma. This||
0526|017|U|medication must be used regularly to be effective. It does not||
0526|018|U|work right away and should not be used to relieve sudden asthma||
0526|019|U|attacks. If an asthma attack occurs, use your quick-relief||
0526|020|U|inhaler (such as albuterol, also called salbutamol in some||
0526|021|U|countries) as prescribed.||
0526|022|U|   Mometasone belongs to a class of drugs known as||
0526|023|U|corticosteroids. It works by reducing the irritation and swelling||
0526|024|U|of the airways. Controlling symptoms of breathing problems can||
0526|025|U|decrease time lost from work or school.||
0526|026|B|||
0526|027|V|OTHER USES:  This section contains uses of this drug that are not||
0526|028|V|listed in the approved professional labeling for the drug but||
0526|029|V|that may be prescribed by your health care professional. Use this||
0526|030|V|drug for a condition that is listed in this section only if it||
0526|031|V|has been so prescribed by your health care professional.||
0526|032|V|   This drug may also be used to control symptoms (such as||
0526|033|V|wheezing and shortness of breath) caused by ongoing lung disease||
0526|034|V|(COPD).||
0526|035|B|||
0526|036|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0526|037|H|your pharmacist before you start using this medication and each||
0526|038|H|time you get a refill. Follow the illustrated directions for the||
0526|039|H|proper use of this medication and proper cleaning of the||
0526|040|H|mouthpiece. If you have any questions, ask your doctor or||
0526|041|H|pharmacist.||
0526|042|H|   Inhale this medication by mouth as directed by your doctor,||
0526|043|H|usually once or twice a day. Do not breathe out (exhale) into the||
0526|044|H|inhaler. The dosage is based on your medical condition, age, and||
0526|045|H|response to treatment.||
0526|046|H|   If two inhalations/puffs are prescribed, wait at least one||
0526|047|H|minute between them. If you are using other inhalers at the same||
0526|048|H|time, wait at least 1 minute between the use of each medication,||
0526|049|H|and use this drug (the corticosteroid) last.||
0526|050|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
0526|051|H|from developing, gargle, rinse your mouth with water and spit out||
0526|052|H|after each use. Do not swallow the rinse water.||
0526|053|H|   Use this medication regularly in order to get the most benefit||
0526|054|H|from it. This medication works best if used at evenly spaced||
0526|055|H|intervals. To help you remember, use it at the same time(s) each||
0526|056|H|day. Do not increase your dose, use this medication more often,||
0526|057|H|or stop using it without first consulting your doctor.||
0526|058|H|   Always have your quick-relief inhaler with you. Keep track of||
0526|059|H|the number of inhalations you use. The inhaler should be||
0526|060|H|discarded when every inhalation has been used (when the dose||
0526|061|H|indicator reads ''00'') or if it has been 45 or 60 days||
0526|062|H|(depending on your brand) after removal from its foil overwrap||
0526|063|H|pouch, whichever comes first.||
0526|064|H|   If you are regularly taking a different corticosteroid by||
0526|065|H|mouth (such as prednisone), you should not stop taking it unless||
0526|066|H|directed by your doctor. Some conditions (such as asthma,||
0526|067|H|allergies) may become worse when the drug is suddenly stopped. If||
0526|068|H|you suddenly stop taking the drug, you may also have withdrawal||
0526|069|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
0526|070|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
0526|071|H|doctor may slowly lower the dose of your old medication after you||
0526|072|H|begin using mometasone. Tell your doctor or pharmacist right away||
0526|073|H|if you have withdrawal. See also Precautions section.||
0526|074|H|   It may take 1 to 2 weeks before you get the full benefit of||
0526|075|H|this drug. Tell your doctor if your symptoms do not get better or||
0526|076|H|if they get worse.||
0526|077|H|   Learn which of your inhalers you should use every day||
0526|078|H|(controller drugs) and which you should use if your breathing||
0526|079|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
0526|080|H|time what you should do if you have new or worsening cough or||
0526|081|H|shortness of breath, wheezing, increased sputum, worsening peak||
0526|082|H|flow meter readings, waking up at night with trouble breathing,||
0526|083|H|if you use your quick-relief inhaler more often (more than 2 days||
0526|084|H|a week), or if your quick-relief inhaler does not seem to be||
0526|085|H|working well. Learn when you can treat sudden breathing problems||
0526|086|H|by yourself and when you must get medical help right away.||
0526|087|B|||
0526|088|S|SIDE EFFECTS:  See also Precautions.||
0526|089|S|   Dry or irritated throat, hoarseness or coughing may occur. If||
0526|090|S|any of these effects last or get worse, notify your doctor or||
0526|091|S|pharmacist promptly.||
0526|092|S|   Remember that this medication has been prescribed because your||
0526|093|S|doctor has judged that the benefit to you is greater than the||
0526|094|S|risk of side effects. Many people using this medication do not||
0526|095|S|have serious side effects.||
0526|096|S|   Tell your doctor right away if you have any serious side||
0526|097|S|effects, including: white patches on tongue/in mouth, signs of||
0526|098|S|infection (such as sore throat that doesn't go away, fever,||
0526|099|S|chills), mental/mood changes (such as depression, trouble||
0526|100|S|sleeping), vision problems (such as blurred vision), increased||
0526|101|S|thirst/urination.||
0526|102|S|   Rarely, this medication has caused severe (rarely fatal),||
0526|103|S|sudden worsening of breathing problems/asthma (paradoxical||
0526|104|S|bronchospasm). If you experience sudden wheezing, get medical||
0526|105|S|help right away.||
0526|106|S|   A very serious allergic reaction to this drug is rare.||
0526|107|S|However, get medical help right away if you notice any symptoms||
0526|108|S|of a serious allergic reaction, including: rash, itching/swelling||
0526|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0526|110|S|breathing.||
0526|111|S|   This is not a complete list of possible side effects. If you||
0526|112|S|notice other effects not listed above, contact your doctor or||
0526|113|S|pharmacist.||
0526|114|S|   In the US -||
0526|115|S|   Call your doctor for medical advice about side effects. You||
0526|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0526|117|S|www.fda.gov/medwatch.||
0526|118|S|   In Canada - Call your doctor for medical advice about side||
0526|119|S|effects. You may report side effects to Health Canada at||
0526|120|S|1-866-234-2345.||
0526|121|B|||
0526|122|P|PRECAUTIONS:  Before using mometasone, tell your doctor or||
0526|123|P|pharmacist if you are allergic to it; or if you have any other||
0526|124|P|allergies. This product may contain inactive ingredients (such as||
0526|125|P|lactose, milk proteins), which can cause allergic reactions or||
0526|126|P|other problems. Talk to your pharmacist for more details.||
0526|127|P|   Before using this medication, tell your doctor or pharmacist||
0526|128|P|your medical history, especially of: current/past infections||
0526|129|P|(such as tuberculosis, herpes), bone loss (osteoporosis), eye||
0526|130|P|problems (such as cataracts, glaucoma), diabetes, decreased||
0526|131|P|adrenal gland function.||
0526|132|P|   If you have switched from a corticosteroid taken by mouth||
0526|133|P|(such as prednisone tablets) to this inhaler within the past 12||
0526|134|P|months, or if you have been using this product in||
0526|135|P|higher-than-usual doses for a long time, it may be more difficult||
0526|136|P|for your body to respond to physical stress. Before having||
0526|137|P|surgery or emergency treatment, or if you get a serious||
0526|138|P|illness/injury, tell your doctor or dentist that you are using||
0526|139|P|this medication or have used a corticosteroid taken by mouth||
0526|140|P|within the past 12 months. Tell your doctor right away if you||
0526|141|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
0526|142|P|card or medical ID bracelet that says you use (or have used)||
0526|143|P|corticosteroid medications.||
0526|144|P|   Before having surgery, tell your doctor or dentist about all||
0526|145|P|the products you use (including prescription drugs,||
0526|146|P|nonprescription drugs, and herbal products).||
0526|147|P|   This medication may mask signs of infection. It can make you||
0526|148|P|more likely to get infections or may make current infections||
0526|149|P|worse. Stay away from anyone who has an infection that may easily||
0526|150|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0526|151|P|doctor if you have been exposed to an infection or for more||
0526|152|P|details.||
0526|153|P|   This medication may temporarily slow down a child's growth if||
0526|154|P|used for a long time. However, poorly controlled asthma can also||
0526|155|P|slow down growth. See the doctor regularly so your child's height||
0526|156|P|can be checked.||
0526|157|P|   During pregnancy, this medication should be used only when||
0526|158|P|clearly needed. Discuss the risks and benefits with your doctor.||
0526|159|P|   It is unknown if this drug passes into breast milk. Consult||
0526|160|P|your doctor before breastfeeding.||
0526|161|B|||
0526|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0526|163|I|medications work or increase your risk for serious side effects.||
0526|164|I|This document does not contain all possible drug interactions.||
0526|165|I|Keep a list of all the products you use (including||
0526|166|I|prescription/nonprescription drugs and herbal products) and share||
0526|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
0526|168|I|the dosage of any medicines without your doctor's approval.||
0526|169|I|   A product that may interact with this drug is: desmopressin.||
0526|170|B|||
0526|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0526|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0526|173|O|poison control center right away. US residents can call||
0526|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0526|175|B|||
0526|176|N|NOTES:  Do not share this medication with others.||
0526|177|N|   Lab and/or medical tests (such as lung function, morning||
0526|178|N|cortisol levels, eye exam, bone density tests) should be done||
0526|179|N|while you are using this medication. Keep all medical and lab||
0526|180|N|appointments. Consult your doctor for more details.||
0526|181|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
0526|182|N|mold that can worsen breathing problems. Because the flu virus||
0526|183|N|can also worsen breathing problems, ask your doctor or pharmacist||
0526|184|N|if you should have a flu shot every year.||
0526|185|N|   This medication may cause bone loss (osteoporosis) in adults||
0526|186|N|when used for a long time. Lifestyle changes that may help reduce||
0526|187|N|the risk of bone problems include doing weight-bearing exercise,||
0526|188|N|stopping smoking, limiting alcohol, and getting enough calcium||
0526|189|N|and vitamin D. Talk to your doctor for more details.||
0526|190|B|||
0526|191|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0526|192|D|If it is near the time of the next dose, skip the missed dose.||
0526|193|D|Use your next dose at the regular time. Do not double the dose to||
0526|194|D|catch up.||
0526|195|B|||
0526|196|R|STORAGE:  Store with the cap securely on at room temperature away||
0526|197|R|from heat and moisture. Do not store in the bathroom. Keep all||
0526|198|R|medications away from children and pets.||
0526|199|R|   Do not flush medications down the toilet or pour them into a||
0526|200|R|drain unless instructed to do so. Properly discard this product||
0526|201|R|when it is expired or no longer needed. Consult your pharmacist||
0526|202|R|or local waste disposal company.||
0526|203|B|||
0526|204|M|MEDICAL ALERT:  Your condition can cause complications in a||
0526|205|M|medical emergency. For information about enrolling in MedicAlert,||
0526|206|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0526|207|B|||
0526|208|A|Information last revised September 2025.||
0526|209|A|Copyright(c) 2025 First Databank, Inc.||
0526|210|B|||
0528|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0528|002|Z|does NOT have all possible information about this product. This||
0528|003|Z|information does not assure that this product is safe, effective,||
0528|004|Z|or appropriate for you. This information is not individual||
0528|005|Z|medical advice and does not substitute for the advice of your||
0528|006|Z|health care professional. Always ask your health care||
0528|007|Z|professional for complete information about this product and your||
0528|008|Z|specific health needs.||
0528|009|B|||
0528|010|T|PREGABALIN - ORAL||
0528|011|F|(pree-GAH-ba-lin)||
0528|012|B|||
0528|013|C|COMMON BRAND NAME(S): Lyrica||
0528|014|B|||
0528|015|U|USES:  This medication is used to treat pain caused by nerve||
0528|016|U|damage due to diabetes, shingles (herpes zoster) infection, or||
0528|017|U|spinal cord injury. This medication is also used to treat pain in||
0528|018|U|people with fibromyalgia.||
0528|019|U|   It is also used with other medications to treat certain types||
0528|020|U|of seizures (focal seizures).||
0528|021|B|||
0528|022|V|OTHER USES:  This section contains uses of this drug that are not||
0528|023|V|listed in the approved professional labeling for the drug but||
0528|024|V|that may be prescribed by your health care professional. Use this||
0528|025|V|drug for a condition that is listed in this section only if it||
0528|026|V|has been so prescribed by your health care professional.||
0528|027|V|   This drug may also be used for hot flashes that occur with||
0528|028|V|menopause, restless legs syndrome (RLS), or anxiety.||
0528|029|B|||
0528|030|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0528|031|H|Patient Information Leaflet provided by your pharmacist before||
0528|032|H|you start using pregabalin and each time you get a refill. If you||
0528|033|H|have any questions, ask your doctor or pharmacist.||
0528|034|H|   Take this medication by mouth with or without food as directed||
0528|035|H|by your doctor, usually 2 to 3 times a day. The dosage is based||
0528|036|H|on your medical condition and response to treatment. Children's||
0528|037|H|dosage is also based on weight.||
0528|038|H|   If you are using the liquid form of this medication, carefully||
0528|039|H|measure the dose using a special measuring device/spoon. Do not||
0528|040|H|use a household spoon because you may not get the correct dose.||
0528|041|H|   To reduce your risk of side effects (such as dizziness and||
0528|042|H|drowsiness), your doctor may direct you to start this medication||
0528|043|H|at a low dose and gradually increase your dose. Follow your||
0528|044|H|doctor's instructions carefully.||
0528|045|H|   Use this medication regularly to get the most benefit from it.||
0528|046|H|To help you remember, take it at the same times each day. This||
0528|047|H|drug works best when the amount of medicine in your body is kept||
0528|048|H|at a constant level. It is best to take pregabalin at evenly||
0528|049|H|spaced intervals throughout the day and night.||
0528|050|H|   Do not stop taking this medication without consulting your||
0528|051|H|doctor. Some conditions (such as seizures) may become worse when||
0528|052|H|this drug is suddenly stopped. Also, you may experience symptoms||
0528|053|H|such as difficulty sleeping, nausea, headache and diarrhea. To||
0528|054|H|prevent these symptoms while you are stopping treatment with this||
0528|055|H|drug, your doctor may reduce your dose gradually. Report any new||
0528|056|H|or worsening symptoms right away.||
0528|057|H|   Though it helps many people, this medication may sometimes||
0528|058|H|cause addiction. This risk may be higher if you have a substance||
0528|059|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0528|060|H|Take this medication exactly as prescribed to lower the risk of||
0528|061|H|addiction. Ask your doctor or pharmacist for more details.||
0528|062|H|   Tell your doctor if your condition lasts or gets worse.||
0528|063|B|||
0528|064|S|SIDE EFFECTS:  Drowsiness, dizziness, dry mouth, constipation,||
0528|065|S|difficulty concentrating, or weight gain may occur. If any of||
0528|066|S|these effects last or get worse, tell your doctor or pharmacist||
0528|067|S|promptly.||
0528|068|S|   Remember that this medication has been prescribed because your||
0528|069|S|doctor has judged that the benefit to you is greater than the||
0528|070|S|risk of side effects. Many people using this medication do not||
0528|071|S|have serious side effects.||
0528|072|S|   Tell your doctor right away if you have serious side effects,||
0528|073|S|including: blurred vision, unusual bleeding/bruising,||
0528|074|S|unsteadiness, confusion, muscle pain/tenderness/weakness||
0528|075|S|(especially if you are tired or have a fever), swelling of||
0528|076|S|hands/legs/feet, signs of kidney problems (such as change in the||
0528|077|S|amount of urine).||
0528|078|S|   A small number of people who take anticonvulsants for any||
0528|079|S|condition (such as seizure, bipolar disorder, pain) may||
0528|080|S|experience depression, suicidal thoughts/attempts, or other||
0528|081|S|mental/mood problems. These effects may occur even after the||
0528|082|S|medication has been stopped. Tell your doctor right away if you||
0528|083|S|or your family/caregiver notice any unusual/sudden changes in||
0528|084|S|your mood, thoughts, or behavior including signs of depression,||
0528|085|S|suicidal thoughts/attempts, thoughts about harming yourself.||
0528|086|S|   Get medical help right away if you have any very serious side||
0528|087|S|effects, including: slow/shallow breathing.||
0528|088|S|   A very serious allergic reaction to this drug is rare.||
0528|089|S|However, get medical help right away if you notice any symptoms||
0528|090|S|of a serious allergic reaction, including: rash, itching/swelling||
0528|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0528|092|S|breathing.||
0528|093|S|   This is not a complete list of possible side effects. If you||
0528|094|S|notice other effects not listed above, contact your doctor or||
0528|095|S|pharmacist.||
0528|096|S|   In the US -||
0528|097|S|   Call your doctor for medical advice about side effects. You||
0528|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0528|099|S|www.fda.gov/medwatch.||
0528|100|S|   In Canada - Call your doctor for medical advice about side||
0528|101|S|effects. You may report side effects to Health Canada at||
0528|102|S|1-866-234-2345.||
0528|103|B|||
0528|104|P|PRECAUTIONS:  Before taking pregabalin, tell your doctor or||
0528|105|P|pharmacist if you are allergic to it; or if you have any other||
0528|106|P|allergies. This product may contain inactive ingredients, which||
0528|107|P|can cause allergic reactions or other problems. Talk to your||
0528|108|P|pharmacist for more details.||
0528|109|P|   Before using this medication, tell your doctor or pharmacist||
0528|110|P|your medical history, especially of: heart problems (such as||
0528|111|P|heart failure), kidney disease, history of an allergic reaction||
0528|112|P|which included itching/swelling of the face/lips/tongue/throat||
0528|113|P|(angioedema), personal or family history of a substance use||
0528|114|P|disorder (such as overuse of or addiction to drugs/alcohol),||
0528|115|P|breathing problems (such as COPD).||
0528|116|P|   This drug may make you dizzy or drowsy or blur your vision.||
0528|117|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0528|118|P|drowsy. Do not drive, use machinery, or do anything that needs||
0528|119|P|alertness or clear vision until you can do it safely. Avoid||
0528|120|P|alcoholic beverages. Talk to your doctor if you are using||
0528|121|P|marijuana (cannabis).||
0528|122|P|   Before having surgery, tell your doctor or dentist about all||
0528|123|P|the products you use (including prescription drugs,||
0528|124|P|nonprescription drugs, and herbal products).||
0528|125|P|   Older adults may be more sensitive to the side effects of this||
0528|126|P|drug, especially drowsiness, dizziness, unsteadiness, confusion,||
0528|127|P|and slow/shallow breathing.||
0528|128|P|   During pregnancy, this medication should be used only when||
0528|129|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0528|130|P|benefits with your doctor.||
0528|131|P|   This drug passes into breast milk. Consult your doctor before||
0528|132|P|breastfeeding.||
0528|133|B|||
0528|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0528|135|I|medications work or increase your risk for serious side effects.||
0528|136|I|This document does not contain all possible drug interactions.||
0528|137|I|Keep a list of all the products you use (including||
0528|138|I|prescription/nonprescription drugs and herbal products) and share||
0528|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
0528|140|I|the dosage of any medicines without your doctor's approval.||
0528|141|I|   A product that may interact with this drug is: orlistat.||
0528|142|I|   The risk of serious side effects (such as slow/shallow||
0528|143|I|breathing, severe drowsiness/dizziness) may be increased if this||
0528|144|I|medication is taken with other products that may also cause||
0528|145|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0528|146|I|if you are using other products such as opioid pain or cough||
0528|147|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0528|148|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0528|149|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0528|150|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0528|151|I|diphenhydramine).||
0528|152|I|   Check the labels on all your medicines (such as allergy or||
0528|153|I|cough-and-cold products) because they may contain ingredients||
0528|154|I|that cause drowsiness. Ask your pharmacist about using those||
0528|155|I|products safely.||
0528|156|B|||
0528|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0528|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0528|159|O|poison control center right away. US residents can call||
0528|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0528|161|B|||
0528|162|N|NOTES:  Do not share this medication with others. Sharing it is||
0528|163|N|against the law.||
0528|164|N|   Lab and/or medical tests (such as kidney function) may be done||
0528|165|N|while you are taking this medication. Keep all medical and lab||
0528|166|N|appointments. Consult your doctor for more details.||
0528|167|B|||
0528|168|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0528|169|D|If it is near the time of the next dose, skip the missed dose.||
0528|170|D|Use your next dose at the regular time. Do not double the dose to||
0528|171|D|catch up.||
0528|172|B|||
0528|173|R|STORAGE:  Store at room temperature away from light and moisture.||
0528|174|R|Do not store in the bathroom. Keep all medications away from||
0528|175|R|children and pets.||
0528|176|R|   Do not flush medications down the toilet or pour them into a||
0528|177|R|drain unless instructed to do so. Properly discard this product||
0528|178|R|when it is expired or no longer needed. Consult your pharmacist||
0528|179|R|or local waste disposal company.||
0528|180|B|||
0528|181|M|MEDICAL ALERT:  Your condition can cause complications in a||
0528|182|M|medical emergency. For information about enrolling in MedicAlert,||
0528|183|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0528|184|B|||
0528|185|A|Information last revised May 2025.||
0528|186|A|Copyright(c) 2025 First Databank, Inc.||
0528|187|B|||
0530|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0530|002|Z|does NOT have all possible information about this product. This||
0530|003|Z|information does not assure that this product is safe, effective,||
0530|004|Z|or appropriate for you. This information is not individual||
0530|005|Z|medical advice and does not substitute for the advice of your||
0530|006|Z|health care professional. Always ask your health care||
0530|007|Z|professional for complete information about this product and your||
0530|008|Z|specific health needs.||
0530|009|B|||
0530|010|T|IRON SUCROSE - INJECTION||
0530|011|F|(iron SOO-krose)||
0530|012|B|||
0530|013|C|COMMON BRAND NAME(S): Venofer||
0530|014|B|||
0530|015|U|USES:  This medicine is used to treat "iron-poor" blood (anemia)||
0530|016|U|in people with long-term kidney disease. You may need extra iron||
0530|017|U|because of blood loss during kidney dialysis. Your body may also||
0530|018|U|need more iron if you use the drug erythropoietin to help make||
0530|019|U|new red blood cells.||
0530|020|U|   Iron is an important part of your red blood cells and is||
0530|021|U|needed to transport oxygen in the body. Many patients with kidney||
0530|022|U|disease cannot get enough iron from food and require injections.||
0530|023|B|||
0530|024|H|HOW TO USE:  This medication is given by injection into a vein as||
0530|025|H|directed by your doctor. It is usually given slowly over 2 to 5||
0530|026|H|minutes or it can also be mixed in a saline solution and given||
0530|027|H|over a longer time. The dosage and length of treatment are based||
0530|028|H|on your medical condition, age, labs, and response to treatment.||
0530|029|H|   Iron sucrose may rarely cause a serious allergic reaction.||
0530|030|H|Careful monitoring during and at least 30 minutes after your||
0530|031|H|treatment may decrease your risk. If you have a serious reaction,||
0530|032|H|your treatment may be stopped. Get medical help right away if you||
0530|033|H|have swelling of the face/tongue/throat, trouble breathing, rash,||
0530|034|H|or hives.||
0530|035|H|   If you are using this medication at home, learn all||
0530|036|H|preparation and usage instructions from your health care||
0530|037|H|professional. Before using, check this product for particles or||
0530|038|H|discoloration. If either is present, do not use the liquid. Learn||
0530|039|H|how to store and discard medical supplies safely.||
0530|040|B|||
0530|041|S|SIDE EFFECTS:  See also How to Use section.||
0530|042|S|   Muscle cramps, nausea, vomiting, strange taste in the mouth,||
0530|043|S|diarrhea, constipation, headache, cough, back pain, joint pain,||
0530|044|S|dizziness, or swelling of the arms/legs may occur. Pain,||
0530|045|S|swelling, or redness at the injection site may occur. If these||
0530|046|S|effects continue or worsen, tell your doctor.||
0530|047|S|   Remember that this medication has been prescribed because your||
0530|048|S|doctor has judged that the benefit to you is greater than the||
0530|049|S|risk of side effects. Many people using this medication do not||
0530|050|S|have serious side effects.||
0530|051|S|   Severe dizziness or fainting (hypotension) may occur while you||
0530|052|S|are receiving IV iron. This may be helped by giving the||
0530|053|S|medication more slowly or at a lower dose. Follow your doctor's||
0530|054|S|directions carefully.||
0530|055|S|   Tell your doctor right away if you have any serious side||
0530|056|S|effects, including: abdominal pain, chest pain, irregular||
0530|057|S|heartbeat (arrhythmias), pressure in the chest, severe headache||
0530|058|S|and blurred vision (hypertension), problems with your dialysis||
0530|059|S|access site (graft).||
0530|060|S|   A very serious allergic reaction to this drug is rare.||
0530|061|S|However, get medical help right away if you notice any symptoms||
0530|062|S|of a serious allergic reaction, including: rash, itching/swelling||
0530|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0530|064|S|breathing.||
0530|065|S|   This is not a complete list of possible side effects. If you||
0530|066|S|notice other effects not listed above, contact your doctor or||
0530|067|S|pharmacist.||
0530|068|S|   In the US -||
0530|069|S|   Call your doctor for medical advice about side effects. You||
0530|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0530|071|S|www.fda.gov/medwatch.||
0530|072|S|   In Canada - Call your doctor for medical advice about side||
0530|073|S|effects. You may report side effects to Health Canada at||
0530|074|S|1-866-234-2345.||
0530|075|B|||
0530|076|P|PRECAUTIONS:  Before using iron sucrose, tell your doctor or||
0530|077|P|pharmacist if you are allergic to it; or if you have any other||
0530|078|P|allergies. This product may contain inactive ingredients, which||
0530|079|P|can cause allergic reactions or other problems. Talk to your||
0530|080|P|pharmacist for more details.||
0530|081|P|   Before using this medication, tell your doctor or pharmacist||
0530|082|P|your medical history.||
0530|083|P|   Before having surgery, tell your doctor or dentist about all||
0530|084|P|the products you use (including prescription drugs,||
0530|085|P|nonprescription drugs, and herbal products).||
0530|086|P|   During pregnancy, this medication should be used only when||
0530|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
0530|088|P|   This medication passes into breast milk. Consult your doctor||
0530|089|P|before breastfeeding.||
0530|090|B|||
0530|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0530|092|I|medications work or increase your risk for serious side effects.||
0530|093|I|This document does not contain all possible drug interactions.||
0530|094|I|Keep a list of all the products you use (including||
0530|095|I|prescription/nonprescription drugs and herbal products) and share||
0530|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
0530|097|I|the dosage of any medicines without your doctor's approval.||
0530|098|B|||
0530|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0530|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0530|101|O|poison control center right away. US residents can call||
0530|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0530|103|B|||
0530|104|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0530|105|N|ferritin, transferrin, total iron binding capacity-TIBC) should||
0530|106|N|be done while you are using this medication. Keep all medical and||
0530|107|N|lab appointments. Consult your doctor for more details.||
0530|108|N|   Remember that it is best to get your vitamins and minerals||
0530|109|N|from food whenever possible. Maintain a well-balanced diet, and||
0530|110|N|follow any dietary guidelines as directed by your doctor. Foods||
0530|111|N|rich in iron include meats (especially liver), eggs, raisins,||
0530|112|N|figs, broccoli, brussels sprouts, beans, lentils, and||
0530|113|N|iron-fortified or enriched cereals.||
0530|114|B|||
0530|115|D|MISSED DOSE:  It is important to get each dose of this medication||
0530|116|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0530|117|D|right away for a new dosing schedule. Do not double the dose to||
0530|118|D|catch up.||
0530|119|B|||
0530|120|R|STORAGE:  Consult the product instructions and your pharmacist||
0530|121|R|for storage details. Keep all medications away from children and||
0530|122|R|pets.||
0530|123|R|   Do not flush medications down the toilet or pour them into a||
0530|124|R|drain unless instructed to do so. Properly discard this product||
0530|125|R|when it is expired or no longer needed. Consult your pharmacist||
0530|126|R|or local waste disposal company.||
0530|127|B|||
0530|128|A|Information last revised October 2025.||
0530|129|A|Copyright(c) 2025 First Databank, Inc.||
0530|130|B|||
0531|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0531|002|Z|does NOT have all possible information about this product. This||
0531|003|Z|information does not assure that this product is safe, effective,||
0531|004|Z|or appropriate for you. This information is not individual||
0531|005|Z|medical advice and does not substitute for the advice of your||
0531|006|Z|health care professional. Always ask your health care||
0531|007|Z|professional for complete information about this product and your||
0531|008|Z|specific health needs.||
0531|009|B|||
0531|010|T|TRIMIPRAMINE - ORAL||
0531|011|F|(trye-MI-pra-meen)||
0531|012|B|||
0531|013|C|COMMON BRAND NAME(S): Surmontil||
0531|014|B|||
0531|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0531|016|W|of conditions, including depression and other mental/mood||
0531|017|W|disorders. These medications can help prevent suicidal||
0531|018|W|thoughts/attempts and provide other important benefits. However,||
0531|019|W|studies have shown that a small number of people (especially||
0531|020|W|people younger than 25) who take antidepressants for any||
0531|021|W|condition may experience worsening depression, other mental/mood||
0531|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0531|023|W|talk with the doctor about the risks and benefits of||
0531|024|W|antidepressant medication (especially for people younger than||
0531|025|W|25), even if treatment is not for a mental/mood condition.||
0531|026|W|   Tell the doctor right away if you notice worsening||
0531|027|W|depression/other psychiatric conditions, unusual behavior changes||
0531|028|W|(including possible suicidal thoughts/attempts), or other||
0531|029|W|mental/mood changes (including new/worsening anxiety, panic||
0531|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0531|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0531|032|W|especially watchful for these symptoms when a new antidepressant||
0531|033|W|is started or when the dose is changed.||
0531|034|B|||
0531|035|U|USES:  This medication is used to treat depression. Trimipramine||
0531|036|U|belongs to a class of drugs known as tricyclic antidepressants.||
0531|037|U|It works by helping to restore the balance of certain natural||
0531|038|U|substances in the brain.||
0531|039|B|||
0531|040|H|HOW TO USE:  Read the Medication Guide provided by your||
0531|041|H|pharmacist before you start taking trimipramine and each time you||
0531|042|H|get a refill. If you have any questions, ask your doctor or||
0531|043|H|pharmacist.||
0531|044|H|   Take this medication by mouth with or without food as directed||
0531|045|H|by your doctor, usually 1 to 3 times daily. If taking this||
0531|046|H|medication once daily, take it at bedtime to decrease the risk of||
0531|047|H|drowsiness. The dosage is based on your medical condition and||
0531|048|H|response to treatment. Your doctor may start you at a low dose||
0531|049|H|and gradually increase your dose. Follow your doctor's||
0531|050|H|instructions carefully.||
0531|051|H|   This medication does not work right away. It may take 2 to 4||
0531|052|H|weeks before you experience the full benefits.||
0531|053|H|   Use this medication regularly in order to get the most benefit||
0531|054|H|from it. To help you remember, use it at the same time(s) each||
0531|055|H|day.||
0531|056|H|   Keep taking this medication even if you feel well. Do not||
0531|057|H|suddenly stop taking this medication without consulting your||
0531|058|H|doctor. Some conditions may become worse when the drug is||
0531|059|H|abruptly stopped. Nausea, headache and a feeling of being ill may||
0531|060|H|also occur. Your dose may need to be gradually decreased.||
0531|061|H|   Tell your doctor if your condition does not get better or if||
0531|062|H|it gets worse.||
0531|063|B|||
0531|064|S|SIDE EFFECTS:  See also the Warning section.||
0531|065|S|   Dizziness, drowsiness, difficulty urinating, headache,||
0531|066|S|weakness, changes in appetite/weight, dry mouth, blurred vision,||
0531|067|S|and constipation may occur. If any of these effects last or get||
0531|068|S|worse, tell your doctor or pharmacist promptly.||
0531|069|S|   To reduce the risk of dizziness and lightheadedness, get up||
0531|070|S|slowly when rising from a sitting or lying position.||
0531|071|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0531|072|S|chips, chew (sugarless) gum, drink water or use a saliva||
0531|073|S|substitute.||
0531|074|S|   To prevent constipation, eat dietary fiber, drink enough||
0531|075|S|water, and exercise. You may also need to take a laxative. Ask||
0531|076|S|your pharmacist which type of laxative is right for you.||
0531|077|S|   Remember that this medication has been prescribed because your||
0531|078|S|doctor has judged that the benefit to you is greater than the||
0531|079|S|risk of side effects. Many people using this medication do not||
0531|080|S|have serious side effects.||
0531|081|S|   Tell your doctor right away if you have any serious side||
0531|082|S|effects, including: mental/mood changes (such as confusion,||
0531|083|S|depression, nervousness), numbness/tingling of the hands/feet,||
0531|084|S|ringing in the ears, sexual problems, shakiness (tremors), severe||
0531|085|S|vomiting/constipation, severe headache, pain/redness/swelling of||
0531|086|S|arms or legs.||
0531|087|S|   Get medical help right away if you have any very serious side||
0531|088|S|effects, including: slow/fast/irregular heartbeat, severe||
0531|089|S|dizziness, fainting, seizures, trouble speaking, weakness on one||
0531|090|S|side of the body, eye pain/swelling/redness, widened pupils,||
0531|091|S|vision changes (such as seeing rainbows around lights at night),||
0531|092|S|chest/jaw/left arm pain.||
0531|093|S|   This medication may increase serotonin and rarely cause a very||
0531|094|S|serious condition called serotonin syndrome/toxicity. The risk||
0531|095|S|increases if you are also taking other drugs that increase||
0531|096|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0531|097|S|take (see Drug Interactions section). Get medical help right away||
0531|098|S|if you develop some of the following symptoms: fast heartbeat,||
0531|099|S|hallucinations, loss of coordination, severe dizziness, severe||
0531|100|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0531|101|S|unusual agitation/restlessness.||
0531|102|S|   This medication may rarely cause serious blood problems (such||
0531|103|S|as agranulocytosis, thrombocytopenia) or liver problems. Tell||
0531|104|S|your doctor right away if you notice any of the following serious||
0531|105|S|side effects: easy bleeding/bruising, signs of infection (such as||
0531|106|S|sore throat that doesn't go away, fever, chills),||
0531|107|S|stomach/abdominal pain, dark urine, yellowing eyes/skin.||
0531|108|S|   A very serious allergic reaction to this product is rare.||
0531|109|S|However, get medical help right away if you notice any symptoms||
0531|110|S|of a serious allergic reaction, including: rash, itching/swelling||
0531|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0531|112|S|breathing.||
0531|113|S|   This is not a complete list of possible side effects. If you||
0531|114|S|notice other effects not listed above, contact your doctor or||
0531|115|S|pharmacist.||
0531|116|S|   In the US -||
0531|117|S|   Call your doctor for medical advice about side effects. You||
0531|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0531|119|S|www.fda.gov/medwatch.||
0531|120|S|   In Canada - Call your doctor for medical advice about side||
0531|121|S|effects. You may report side effects to Health Canada at||
0531|122|S|1-866-234-2345.||
0531|123|B|||
0531|124|P|PRECAUTIONS:  See also the Warning section.||
0531|125|P|   Before taking trimipramine, tell your doctor or pharmacist if||
0531|126|P|you are allergic to it; or to other tricyclic antidepressants||
0531|127|P|(such as amitriptyline, imipramine); or if you have any other||
0531|128|P|allergies. This product may contain inactive ingredients, which||
0531|129|P|can cause allergic reactions or other problems. Talk to your||
0531|130|P|pharmacist for more details.||
0531|131|P|   Before using this medication, tell your doctor or pharmacist||
0531|132|P|your medical history, especially of: blood problems (such as||
0531|133|P|agranulocytosis, thrombocytopenia), breathing problems (such as||
0531|134|P|asthma, chronic obstructive pulmonary disorder-COPD), diabetes,||
0531|135|P|electroshock therapy, personal or family history of glaucoma||
0531|136|P|(angle-closure type), heart problems (such as recent heart||
0531|137|P|attack, arrhythmias, coronary artery disease), intestinal||
0531|138|P|problems (such as chronic constipation, ileus), kidney problems,||
0531|139|P|liver problems, other mental/mood conditions (such as bipolar||
0531|140|P|disorder, psychosis), family history of mental/mood conditions||
0531|141|P|(such as suicide, bipolar disorder), seizures, conditions that||
0531|142|P|may increase your risk of seizures (such as bulimia, organic||
0531|143|P|brain disease, alcohol withdrawal), overactive thyroid||
0531|144|P|(hyperthyroidism), problems urinating (urinary retention,||
0531|145|P|enlarged prostate).||
0531|146|P|   Trimipramine may cause a condition that affects the heart||
0531|147|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0531|148|P|serious (rarely fatal) fast/irregular heartbeat and other||
0531|149|P|symptoms (such as severe dizziness, fainting) that need medical||
0531|150|P|attention right away.||
0531|151|P|   The risk of QT prolongation may be increased if you have||
0531|152|P|certain medical conditions or are taking other drugs that may||
0531|153|P|cause QT prolongation. Before using trimipramine, tell your||
0531|154|P|doctor or pharmacist of all the drugs you take and if you have||
0531|155|P|any of the following conditions: certain heart problems (heart||
0531|156|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0531|157|P|history of certain heart problems (QT prolongation in the EKG,||
0531|158|P|sudden cardiac death).||
0531|159|P|   Low levels of potassium or magnesium in the blood may also||
0531|160|P|increase your risk of QT prolongation. This risk may increase if||
0531|161|P|you use certain drugs (such as diuretics/"water pills") or if you||
0531|162|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0531|163|P|Talk to your doctor about using trimipramine safely.||
0531|164|P|   This drug may make you dizzy or drowsy or blur your vision.||
0531|165|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0531|166|P|drowsy. Do not drive, use machinery, or do anything that needs||
0531|167|P|alertness or clear vision until you can do it safely. Limit||
0531|168|P|alcoholic beverages. Talk to your doctor if you are using||
0531|169|P|marijuana (cannabis).||
0531|170|P|   Before having surgery, tell your doctor or dentist about all||
0531|171|P|the products you use (including prescription drugs,||
0531|172|P|nonprescription drugs, and herbal products).||
0531|173|P|   This medication may make you more sensitive to the sun. Limit||
0531|174|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0531|175|P|sunscreen and wear protective clothing when outdoors. Tell your||
0531|176|P|doctor right away if you get sunburned or have skin||
0531|177|P|blisters/redness.||
0531|178|P|   This drug may rarely make your blood sugar rise, which can||
0531|179|P|cause or worsen diabetes. If you have diabetes, check your blood||
0531|180|P|sugar regularly as directed and share the results with your||
0531|181|P|doctor. Tell your doctor right away if you have symptoms of high||
0531|182|P|blood sugar such as increased thirst/urination. Your doctor may||
0531|183|P|need to adjust your diabetes medication, exercise program, or||
0531|184|P|diet.||
0531|185|P|   Older adults may be more sensitive to the side effects of this||
0531|186|P|drug, especially dizziness (more likely when standing up),||
0531|187|P|drowsiness, confusion, constipation, trouble urinating or QT||
0531|188|P|prolongation (see above). Drowsiness, dizziness, or confusion can||
0531|189|P|increase the risk of falling.||
0531|190|P|   During pregnancy, this medication should be used only when||
0531|191|P|clearly needed. Infants born to mothers who have taken similar||
0531|192|P|medications during pregnancy may develop trouble urinating,||
0531|193|P|lethargy, shaking (tremors), and seizures. Discuss the risks and||
0531|194|P|benefits with your doctor.||
0531|195|P|   Since untreated mental/mood problems (such as depression) can||
0531|196|P|be a serious condition, do not stop taking this medication unless||
0531|197|P|directed by your doctor. If you are planning pregnancy, become||
0531|198|P|pregnant, or think you may be pregnant, immediately discuss with||
0531|199|P|your doctor the benefits and risks of using this medication||
0531|200|P|during pregnancy.||
0531|201|P|   It is unknown if this medication passes into breast milk.||
0531|202|P|Consult your doctor before breastfeeding.||
0531|203|B|||
0531|204|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0531|205|I|medications work or increase your risk for serious side effects.||
0531|206|I|This document does not contain all possible drug interactions.||
0531|207|I|Keep a list of all the products you use (including||
0531|208|I|prescription/nonprescription drugs and herbal products) and share||
0531|209|I|it with your doctor and pharmacist. Do not start, stop, or change||
0531|210|I|the dosage of any medicines without your doctor's approval.||
0531|211|I|   Taking MAO inhibitors with this medication may cause a serious||
0531|212|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
0531|213|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0531|214|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0531|215|I|selegiline, tranylcypromine) during treatment with this||
0531|216|I|medication. Some MAO inhibitors should also not be taken for two||
0531|217|I|weeks before or after treatment with this medication. Ask your||
0531|218|I|doctor when to start or stop taking this medication.||
0531|219|I|   The risk of serotonin syndrome/toxicity increases if you are||
0531|220|I|also taking other drugs that increase serotonin. Examples include||
0531|221|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0531|222|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0531|223|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0531|224|I|serotonin syndrome/toxicity may be more likely when you start or||
0531|225|I|increase the dose of these drugs.||
0531|226|I|   Many drugs besides trimipramine may affect the heart rhythm||
0531|227|I|(QT prolongation in the EKG), including disopyramide,||
0531|228|I|dronedarone, among others. Before using trimipramine, report all||
0531|229|I|medications you are currently using to your doctor or pharmacist.||
0531|230|I|   Tell your doctor or pharmacist if you are taking other||
0531|231|I|products that cause drowsiness such as opioid pain or cough||
0531|232|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0531|233|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0531|234|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0531|235|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0531|236|I|diphenhydramine).||
0531|237|I|   Check the labels on all your medicines (such as allergy or||
0531|238|I|cough-and-cold products) because they may contain ingredients||
0531|239|I|that cause drowsiness. Ask your pharmacist about using those||
0531|240|I|products safely.||
0531|241|B|||
0531|242|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0531|243|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0531|244|O|poison control center right away. US residents can call||
0531|245|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0531|246|O|Overdose of this medication may be fatal, and symptoms include||
0531|247|O|seizures, delirium and loss of consciousness.||
0531|248|B|||
0531|249|N|NOTES:  Do not share this medication with others.||
0531|250|N|   Lab and/or medical tests (such as blood counts, kidney/liver||
0531|251|N|function) may be done while you are taking this medication. Keep||
0531|252|N|all medical and lab appointments. Consult your doctor for more||
0531|253|N|details.||
0531|254|B|||
0531|255|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0531|256|D|remember. If it is near the time of the next dose, skip the||
0531|257|D|missed dose. Take your next dose at the regular time. Do not||
0531|258|D|double the dose to catch up.||
0531|259|B|||
0531|260|R|STORAGE:  Store at room temperature away from light and moisture.||
0531|261|R|Do not store in the bathroom. Keep all medications away from||
0531|262|R|children and pets.||
0531|263|R|   Do not flush medications down the toilet or pour them into a||
0531|264|R|drain unless instructed to do so. Properly discard this product||
0531|265|R|when it is expired or no longer needed. Consult your pharmacist||
0531|266|R|or local waste disposal company.||
0531|267|B|||
0531|268|A|Information last revised April 2025.||
0531|269|A|Copyright(c) 2025 First Databank, Inc.||
0531|270|B|||
0533|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0533|002|Z|does NOT have all possible information about this product. This||
0533|003|Z|information does not assure that this product is safe, effective,||
0533|004|Z|or appropriate for you. This information is not individual||
0533|005|Z|medical advice and does not substitute for the advice of your||
0533|006|Z|health care professional. Always ask your health care||
0533|007|Z|professional for complete information about this product and your||
0533|008|Z|specific health needs.||
0533|009|B|||
0533|010|T|PIOGLITAZONE/METFORMIN - ORAL||
0533|011|F|(PYE-oh-GLI-ta-zone/met-FOR-min)||
0533|012|B|||
0533|013|C|COMMON BRAND NAME(S): Actoplus Met||
0533|014|B|||
0533|015|W|WARNING:  Pioglitazone may rarely cause or worsen a certain heart||
0533|016|W|problem (heart failure). Tell your doctor right away if you||
0533|017|W|notice any symptoms of heart failure, including: shortness of||
0533|018|W|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
0533|019|W|weight gain.||
0533|020|W|   This medication is not recommended for people with certain||
0533|021|W|types of heart failure. Before using this medication, tell your||
0533|022|W|doctor if you have heart failure.||
0533|023|W|   Rarely, too much metformin can build up in the body and cause||
0533|024|W|a serious (sometimes fatal) condition called lactic acidosis.||
0533|025|W|Lactic acidosis is more likely if you are an older adult, if you||
0533|026|W|have kidney or liver disease, dehydration, heart failure, heavy||
0533|027|W|alcohol use, if you have surgery, if you have X-ray or scanning||
0533|028|W|procedures that use iodinated contrast, or if you are using||
0533|029|W|certain drugs. For some conditions, your doctor may tell you to||
0533|030|W|stop taking this medication for a short time. Ask your doctor or||
0533|031|W|pharmacist for more details.||
0533|032|W|   Stop taking this medication and get medical help right away if||
0533|033|W|you have any symptoms of lactic acidosis, such as unusual||
0533|034|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
0533|035|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
0533|036|W|or stomach pain with nausea/vomiting/diarrhea.||
0533|037|B|||
0533|038|U|USES:  This combination medication is used along with a proper||
0533|039|U|diet and exercise program to control high blood sugar in people||
0533|040|U|with type 2 diabetes. Controlling high blood sugar helps prevent||
0533|041|U|kidney damage, blindness, nerve problems, loss of limbs, and||
0533|042|U|sexual function problems. Proper control of diabetes may also||
0533|043|U|lessen your risk of a heart attack or stroke.||
0533|044|U|   Pioglitazone belongs to a class of drugs known as||
0533|045|U|thiazolidinediones or "glitazones". Metformin and pioglitazone||
0533|046|U|work by helping to restore your body's proper response to the||
0533|047|U|insulin you naturally produce. Metformin also decreases the||
0533|048|U|amount of sugar that your liver makes and that your||
0533|049|U|stomach/intestines absorb.||
0533|050|U|   Talk to your doctor about the risks and benefits of using||
0533|051|U|pioglitazone-containing products.||
0533|052|B|||
0533|053|H|HOW TO USE:  Read the Medication Guide provided by your||
0533|054|H|pharmacist before you start taking pioglitazone/metformin and||
0533|055|H|each time you get a refill. If you have any questions, ask your||
0533|056|H|doctor or pharmacist.||
0533|057|H|   Take this medication by mouth as directed by your doctor,||
0533|058|H|usually once or twice daily with meals to decrease stomach upset.||
0533|059|H|Drink plenty of fluids while taking this medication unless||
0533|060|H|otherwise directed by your doctor.||
0533|061|H|   The dosage is based on your medical condition, response to||
0533|062|H|treatment, and other medications you may be taking. Be sure to||
0533|063|H|tell your doctor and pharmacist about all the products you use||
0533|064|H|(including prescription drugs, nonprescription drugs, and herbal||
0533|065|H|products). To reduce your risk of side effects (such as upset||
0533|066|H|stomach), your doctor may direct you to start this medication at||
0533|067|H|a low dose and gradually increase your dose. Follow your doctor's||
0533|068|H|instructions carefully.||
0533|069|H|   Take this medication regularly in order to get the most||
0533|070|H|benefit from it. Remember to use it at the same time(s) each day.||
0533|071|H|   If you are already taking another diabetes medication, follow||
0533|072|H|your doctor's directions carefully for stopping/continuing the||
0533|073|H|old drug and starting this medication.||
0533|074|H|   Check your blood sugar regularly as directed by your doctor.||
0533|075|H|Keep track of the results, and share them with your doctor. Tell||
0533|076|H|your doctor if your blood sugar measurements are too high or too||
0533|077|H|low. Your dosage/treatment may need to be changed. It may take up||
0533|078|H|to 2 to 3 months before the full benefit of this drug takes||
0533|079|H|effect.||
0533|080|B|||
0533|081|S|SIDE EFFECTS:  See also Warning section.||
0533|082|S|   Nausea, vomiting, stomach upset, diarrhea, weakness, sore||
0533|083|S|throat, muscle pain, weight gain, tooth problems or a metallic||
0533|084|S|taste in the mouth may occur. If any of these effects last or get||
0533|085|S|worse, tell your doctor or pharmacist promptly. If stomach||
0533|086|S|symptoms return later (after taking the same dose for several||
0533|087|S|days or weeks), tell your doctor right away. Stomach symptoms||
0533|088|S|that occur after the first days of your treatment may be signs of||
0533|089|S|lactic acidosis.||
0533|090|S|   Remember that this medication has been prescribed because your||
0533|091|S|doctor has judged that the benefit to you is greater than the||
0533|092|S|risk of side effects. Many people using this medication do not||
0533|093|S|have serious side effects.||
0533|094|S|   Tell your doctor right away if you have any serious side||
0533|095|S|effects, including: new/worsening vision problems (such as||
0533|096|S|blurred vision), bone fracture, reddish-colored urine, urgent||
0533|097|S|need to urinate, pain while urinating, signs of liver disease||
0533|098|S|(such as nausea/vomiting that doesn't stop, dark urine, yellowing||
0533|099|S|eyes/skin, stomach/abdominal pain).||
0533|100|S|   This medication does not usually cause low blood sugar||
0533|101|S|(hypoglycemia). Low blood sugar may occur if this drug is||
0533|102|S|prescribed with other diabetes medications, or if you do not get||
0533|103|S|enough calories from food, or if you do unusually heavy exercise.||
0533|104|S|Talk with your doctor or pharmacist about whether the dose of||
0533|105|S|your other diabetes medication(s) needs to be lowered. Symptoms||
0533|106|S|of low blood sugar include sudden sweating, shaking, fast||
0533|107|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
0533|108|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
0533|109|S|treat low blood sugar. If you don't have these reliable forms of||
0533|110|S|glucose, rapidly raise your blood sugar by eating a quick source||
0533|111|S|of sugar such as table sugar, honey, or candy, or drink fruit||
0533|112|S|juice or non-diet soda. Tell your doctor right away about the||
0533|113|S|reaction and the use of this product. To help prevent low blood||
0533|114|S|sugar, eat meals on a regular schedule, and do not skip meals.||
0533|115|S|Check with your doctor or pharmacist to find out what you should||
0533|116|S|do if you miss a meal.||
0533|117|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0533|118|S|thirst/urination. If these symptoms occur, tell your doctor right||
0533|119|S|away. Your doctor may need to adjust your diabetes medication,||
0533|120|S|exercise program, or diet.||
0533|121|S|   A very serious allergic reaction to this drug is rare.||
0533|122|S|However, get medical help right away if you notice any symptoms||
0533|123|S|of a serious allergic reaction, including: rash, itching/swelling||
0533|124|S|(especially of the face/tongue/throat), dizziness, trouble||
0533|125|S|breathing.||
0533|126|S|   This is not a complete list of possible side effects. If you||
0533|127|S|notice other effects not listed above, contact your doctor or||
0533|128|S|pharmacist.||
0533|129|S|   In the US -||
0533|130|S|   Call your doctor for medical advice about side effects. You||
0533|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0533|132|S|www.fda.gov/medwatch.||
0533|133|S|   In Canada - Call your doctor for medical advice about side||
0533|134|S|effects. You may report side effects to Health Canada at||
0533|135|S|1-866-234-2345.||
0533|136|B|||
0533|137|P|PRECAUTIONS:  See also Warning section.||
0533|138|P|   Before taking this medication, tell your doctor or pharmacist||
0533|139|P|if you are allergic to pioglitazone or metformin; or if you have||
0533|140|P|any other allergies. This product may contain inactive||
0533|141|P|ingredients, which can cause allergic reactions or other||
0533|142|P|problems. Talk to your pharmacist for more details.||
0533|143|P|   Before using this medication, tell your doctor or pharmacist||
0533|144|P|your medical history, especially of: breathing problems (such as||
0533|145|P|obstructive lung disease, asthma), blood problems (such as||
0533|146|P|anemia, vitamin B12 deficiency), kidney disease, liver disease,||
0533|147|P|heart disease (such as heart failure, chest pain), fluid in your||
0533|148|P|lungs, swelling (edema), a certain eye problem (macular edema),||
0533|149|P|bladder cancer.||
0533|150|P|   Before having surgery or any X-ray/scanning procedure using||
0533|151|P|iodinated contrast, tell your doctor or dentist about all the||
0533|152|P|products you use (including prescription drugs, nonprescription||
0533|153|P|drugs, and herbal products). You may need to stop this medication||
0533|154|P|for a short time for the surgery/procedure. Ask your doctor or||
0533|155|P|dentist for instructions before your surgery/procedure.||
0533|156|P|   You may experience blurred vision, dizziness, or drowsiness||
0533|157|P|due to extremely low or high blood sugar. Do not drive, use||
0533|158|P|machinery, or do anything that needs alertness or clear vision||
0533|159|P|until you can do it safely.||
0533|160|P|   Limit alcohol while using this medication because it can||
0533|161|P|increase your risk of lactic acidosis and developing low blood||
0533|162|P|sugar.||
0533|163|P|   High fever, "water pills" (diuretics such as||
0533|164|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
0533|165|P|may cause dehydration and increase your risk of lactic acidosis.||
0533|166|P|Stop taking this medication and tell your doctor right away if||
0533|167|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
0533|168|P|fluids to prevent dehydration unless your doctor directs you||
0533|169|P|otherwise.||
0533|170|P|   It may be harder to control your blood sugar when your body is||
0533|171|P|stressed (such as due to fever, infection, injury, or surgery).||
0533|172|P|Consult your doctor because increased stress may require a change||
0533|173|P|in your treatment plan, medications, or blood sugar testing.||
0533|174|P|   Pioglitazone may increase the risk of bone fracture in women||
0533|175|P|(usually in the upper arm, hand, or foot). See also Notes||
0533|176|P|section.||
0533|177|P|   Older adults may be at greater risk for side effects such as||
0533|178|P|low blood sugar or lactic acidosis.||
0533|179|P|   During pregnancy, this medication should be used only when||
0533|180|P|clearly needed. Discuss the risks and benefits with your doctor.||
0533|181|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
0533|182|P|your doctor for managing your blood sugar while pregnant. Your||
0533|183|P|doctor may change your diabetes treatment during your pregnancy||
0533|184|P|(such as diet and medications including insulin).||
0533|185|P|   This medication can cause changes in the menstrual cycle||
0533|186|P|(promote ovulation) and increase the risk of becoming pregnant.||
0533|187|P|Consult your doctor or pharmacist about the use of reliable birth||
0533|188|P|control while using this medication.||
0533|189|P|   Metformin passes into breast milk in small amounts. It is||
0533|190|P|unknown if pioglitazone passes into breast milk. Consult your||
0533|191|P|doctor before breastfeeding.||
0533|192|B|||
0533|193|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0533|194|I|medications work or increase your risk for serious side effects.||
0533|195|I|This document does not contain all possible drug interactions.||
0533|196|I|Keep a list of all the products you use (including||
0533|197|I|prescription/nonprescription drugs and herbal products) and share||
0533|198|I|it with your doctor and pharmacist. Do not start, stop, or change||
0533|199|I|the dosage of any medicines without your doctor's approval.||
0533|200|I|   Other medications can affect the removal of pioglitazone from||
0533|201|I|your body, which may affect how pioglitazone works. Examples||
0533|202|I|include gemfibrozil, rifamycins including rifampin, among others.||
0533|203|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0533|204|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0533|205|I|heartbeat you would usually feel when your blood sugar falls too||
0533|206|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0533|207|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0533|208|I|   Many drugs can affect your blood sugar, making it harder to||
0533|209|I|control. Before you start, stop, or change any medication, talk||
0533|210|I|with your doctor or pharmacist about how the medication may||
0533|211|I|affect your blood sugar. Check your blood sugar regularly as||
0533|212|I|directed and share the results with your doctor. Tell your doctor||
0533|213|I|right away if you have symptoms of high or low blood sugar. (See||
0533|214|I|also Side Effects section.) Your doctor may need to adjust your||
0533|215|I|diabetes medication, exercise program, or diet.||
0533|216|B|||
0533|217|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0533|218|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0533|219|O|poison control center right away. US residents can call||
0533|220|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0533|221|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
0533|222|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
0533|223|O|rapid breathing, slow/irregular heartbeat.||
0533|224|B|||
0533|225|N|NOTES:  Do not share this medication with others.||
0533|226|N|   Attend a diabetes education program to learn more about how to||
0533|227|N|manage your diabetes with medications, diet, exercise, and||
0533|228|N|regular medical exams.||
0533|229|N|   Lifestyle changes that help promote healthy bones include||
0533|230|N|increasing weight-bearing exercise, eating well-balanced meals||
0533|231|N|containing adequate calcium and vitamin D, stopping smoking, and||
0533|232|N|limiting alcohol. Consult your doctor to see if you need to take||
0533|233|N|calcium/vitamin D supplements and discuss lifestyle changes that||
0533|234|N|might benefit you.||
0533|235|N|   Learn the symptoms of high and low blood sugar and how to||
0533|236|N|treat low blood sugar. Check your blood sugar regularly as||
0533|237|N|directed.||
0533|238|N|   Lab and/or medical tests (such as kidney/liver function, blood||
0533|239|N|sugar, hemoglobin A1c, complete blood counts, eye exams) should||
0533|240|N|be done before you start taking this medication and while you are||
0533|241|N|taking it. Keep all medical and lab appointments. Consult your||
0533|242|N|doctor for more details.||
0533|243|B|||
0533|244|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0533|245|D|remember. If it is near the time of the next dose, skip the||
0533|246|D|missed dose. Take your next dose at the regular time. Do not||
0533|247|D|double the dose to catch up.||
0533|248|B|||
0533|249|R|STORAGE:  Store at room temperature away from light and moisture.||
0533|250|R|Do not store in the bathroom. Keep all medications away from||
0533|251|R|children and pets.||
0533|252|R|   Do not flush medications down the toilet or pour them into a||
0533|253|R|drain unless instructed to do so. Properly discard this product||
0533|254|R|when it is expired or no longer needed. Consult your pharmacist||
0533|255|R|or local waste disposal company.||
0533|256|B|||
0533|257|M|MEDICAL ALERT:  Your condition can cause complications in a||
0533|258|M|medical emergency. For information about enrolling in MedicAlert,||
0533|259|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0533|260|B|||
0533|261|A|Information last revised November 2025.||
0533|262|A|Copyright(c) 2025 First Databank, Inc.||
0533|263|B|||
0534|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0534|002|Z|does NOT have all possible information about this product. This||
0534|003|Z|information does not assure that this product is safe, effective,||
0534|004|Z|or appropriate for you. This information is not individual||
0534|005|Z|medical advice and does not substitute for the advice of your||
0534|006|Z|health care professional. Always ask your health care||
0534|007|Z|professional for complete information about this product and your||
0534|008|Z|specific health needs.||
0534|009|B|||
0534|010|T|TOBRAMYCIN/DEXAMETHASONE OINTMENT - OPHTHALMIC||
0534|011|F|(TOE-bra-MYE-sin/dex-uh-METH-uh-sown)||
0534|012|B|||
0534|013|C|COMMON BRAND NAME(S): Tobradex||
0534|014|B|||
0534|015|U|USES:  This medication is used to treat or prevent eye||
0534|016|U|infections. This medication contains two drugs. Tobramycin||
0534|017|U|belongs to a class of drugs called aminoglycoside antibiotics. It||
0534|018|U|works by stopping the growth of bacteria. Dexamethasone belongs||
0534|019|U|to a class of drugs called corticosteroids. It works by reducing||
0534|020|U|swelling.||
0534|021|U|   This medication treats/prevents only bacterial eye infections.||
0534|022|U|It will not work for other types of eye infections. Unnecessary||
0534|023|U|use or overuse of any antibiotic can lead to its decreased||
0534|024|U|effectiveness.||
0534|025|B|||
0534|026|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0534|027|H|directed by your doctor, usually 3 to 4 times a day.||
0534|028|H|   Do not wear contact lenses while you are using this medicine.||
0534|029|H|Sterilize contact lenses according to manufacturer's directions||
0534|030|H|and check with your doctor before you begin using them again.||
0534|031|H|   To apply the eye ointment, wash your hands first. To avoid||
0534|032|H|contamination, do not touch the tube tip or let it touch your eye||
0534|033|H|or any other surface. Tilt your head back, look upward, and pull||
0534|034|H|down the lower eyelid to make a pouch. Place a 1/2 inch (1.3||
0534|035|H|centimeters) strip of ointment into the pouch by squeezing the||
0534|036|H|tube gently. Close the eye and roll the eyeball in all directions||
0534|037|H|to spread the medication. Try not to blink and do not rub the||
0534|038|H|eye. Repeat these steps for your other eye if so directed. Wipe||
0534|039|H|the tip of the ointment tube with a clean tissue to remove excess||
0534|040|H|medication before recapping it.||
0534|041|H|   The dosage is based on your medical condition and response to||
0534|042|H|treatment.||
0534|043|H|   If you are using another kind of eye medication (such as drops||
0534|044|H|or ointments), wait at least 5 to 10 minutes before applying||
0534|045|H|other medications. Use eye drops before eye ointments to allow||
0534|046|H|the eye drops to enter the eye.||
0534|047|H|   Wait several minutes for your vision to clear before driving||
0534|048|H|or operating machinery.||
0534|049|H|   Use this medication regularly in order to get the most benefit||
0534|050|H|from it. To help you remember, use it at the same times each day.||
0534|051|H|Continue to use this medication for the full time prescribed,||
0534|052|H|even if symptoms disappear after a few days. Stopping the||
0534|053|H|medication too early may result in a return of the infection.||
0534|054|H|   Tell your doctor if your condition lasts or gets worse.||
0534|055|B|||
0534|056|S|SIDE EFFECTS:  Temporary blurred vision, eye redness, eye||
0534|057|S|discomfort, and eyelid itching/swelling may occur. If any of||
0534|058|S|these effects last or get worse, notify your doctor or pharmacist||
0534|059|S|promptly.||
0534|060|S|   Remember that this medication has been prescribed because your||
0534|061|S|doctor has judged that the benefit to you is greater than the||
0534|062|S|risk of side effects. Many people using this medication do not||
0534|063|S|have serious side effects.||
0534|064|S|   Use of this medication for prolonged/repeated periods may||
0534|065|S|result in a new fungal eye infection and may increase your risk||
0534|066|S|for other eye problems (such as glaucoma, cataracts). Do not use||
0534|067|S|this medication for longer than prescribed. Tell your doctor||
0534|068|S|right away if you notice any of the following: new or worsening||
0534|069|S|eye symptoms (such as discharge, swelling), vision changes, eye||
0534|070|S|pain.||
0534|071|S|   A very serious allergic reaction to this drug is rare.||
0534|072|S|However, get medical help right away if you notice any symptoms||
0534|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0534|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0534|075|S|breathing.||
0534|076|S|   This is not a complete list of possible side effects. If you||
0534|077|S|notice other effects not listed above, contact your doctor or||
0534|078|S|pharmacist.||
0534|079|S|   In the US -||
0534|080|S|   Call your doctor for medical advice about side effects. You||
0534|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0534|082|S|www.fda.gov/medwatch.||
0534|083|S|   In Canada - Call your doctor for medical advice about side||
0534|084|S|effects. You may report side effects to Health Canada at||
0534|085|S|1-866-234-2345.||
0534|086|B|||
0534|087|P|PRECAUTIONS:  Before using tobramycin with dexamethasone, tell||
0534|088|P|your doctor or pharmacist if you are allergic to either drug; or||
0534|089|P|to other aminoglycoside antibiotics (such as gentamicin); or if||
0534|090|P|you have any other allergies. This product may contain inactive||
0534|091|P|ingredients, which can cause allergic reactions or other||
0534|092|P|problems. Talk to your pharmacist for more details.||
0534|093|P|   Before using this medication, tell your doctor or pharmacist||
0534|094|P|your medical history, especially of: other eye problems (such as||
0534|095|P|glaucoma).||
0534|096|P|   After you apply this drug, your vision may become temporarily||
0534|097|P|blurred or unstable. Do not drive, use machinery, or do anything||
0534|098|P|that needs clear vision until you can do it safely.||
0534|099|P|   During pregnancy, this medication should be used only when||
0534|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0534|101|P|   It is unknown if this medication passes into breast milk.||
0534|102|P|Consult your doctor before breastfeeding.||
0534|103|B|||
0534|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0534|105|I|medications work or increase your risk for serious side effects.||
0534|106|I|This document does not contain all possible drug interactions.||
0534|107|I|Keep a list of all the products you use (including||
0534|108|I|prescription/nonprescription drugs and herbal products) and share||
0534|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
0534|110|I|the dosage of any medicines without your doctor's approval.||
0534|111|B|||
0534|112|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0534|113|O|has overdosed and has serious symptoms such as passing out or||
0534|114|O|trouble breathing, call 911. Otherwise, call a poison control||
0534|115|O|center right away. US residents can call 1-800-222-1222. Canada||
0534|116|O|residents can call 1-844-764-7669.||
0534|117|B|||
0534|118|N|NOTES:  Do not share this medication with others.||
0534|119|N|   This medication has been prescribed for your current condition||
0534|120|N|only. Throw away the unused medication after treatment is||
0534|121|N|completed. Do not use it later for another infection unless your||
0534|122|N|doctor tells you to.||
0534|123|N|   If you are using this medication for more than 10 days, lab||
0534|124|N|and/or medical tests (such as eye exams) should be done while you||
0534|125|N|are using this medication. Keep all medical and lab appointments.||
0534|126|N|Consult your doctor for more details.||
0534|127|B|||
0534|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0534|129|D|If it is near the time of the next dose, skip the missed dose.||
0534|130|D|Use your next dose at the regular time. Do not double the dose to||
0534|131|D|catch up.||
0534|132|B|||
0534|133|R|STORAGE:  Store at room temperature or in the refrigerator. Keep||
0534|134|R|all medications away from children and pets.||
0534|135|R|   Do not flush medications down the toilet or pour them into a||
0534|136|R|drain unless instructed to do so. Properly discard this product||
0534|137|R|when it is expired or no longer needed. Consult your pharmacist||
0534|138|R|or local waste disposal company.||
0534|139|B|||
0534|140|A|Information last revised November 2024.||
0534|141|A|Copyright(c) 2025 First Databank, Inc.||
0534|142|B|||
0535|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0535|002|Z|does NOT have all possible information about this product. This||
0535|003|Z|information does not assure that this product is safe, effective,||
0535|004|Z|or appropriate for you. This information is not individual||
0535|005|Z|medical advice and does not substitute for the advice of your||
0535|006|Z|health care professional. Always ask your health care||
0535|007|Z|professional for complete information about this product and your||
0535|008|Z|specific health needs.||
0535|009|B|||
0535|010|T|SUCRALFATE SUSPENSION - ORAL||
0535|011|F|(sue-KRAL-fate)||
0535|012|B|||
0535|013|C|COMMON BRAND NAME(S): Carafate||
0535|014|B|||
0535|015|U|USES:  This medication is used to treat ulcers in the intestines.||
0535|016|U|Sucralfate forms a coating over ulcers, protecting the area from||
0535|017|U|further injury. This helps ulcers heal more quickly.||
0535|018|B|||
0535|019|H|HOW TO USE:  Shake the bottle well before each dose. Take this||
0535|020|H|medicine by mouth on an empty stomach (at least 1 hour before a||
0535|021|H|meal) as directed by your doctor, usually 4 times daily. The||
0535|022|H|dosage is based on your medical condition and response to||
0535|023|H|treatment.||
0535|024|H|   Use this medication regularly in order to get the most benefit||
0535|025|H|from it. To help you remember, use it at the same times each day.||
0535|026|H|It is important to keep taking this medication even if you do not||
0535|027|H|feel ulcer pain. Do not stop taking this medication without||
0535|028|H|consulting your doctor. It may take 4 to 8 weeks for your ulcer||
0535|029|H|to heal completely.||
0535|030|H|   Some medications may not work as well if you take them at the||
0535|031|H|same time as sucralfate. They may need to be taken at a different||
0535|032|H|time of the day than the time you take sucralfate. Ask your||
0535|033|H|doctor or pharmacist for help making a dosing schedule that will||
0535|034|H|work with all your medications.||
0535|035|H|   Antacids can be used with this medicine, but they should be||
0535|036|H|taken at least 30 minutes before or after sucralfate.||
0535|037|H|   Tell your doctor if your condition lasts or gets worse after||
0535|038|H|you have been taking sucralfate for 4 weeks.||
0535|039|B|||
0535|040|S|SIDE EFFECTS:  Constipation, dry mouth, upset stomach, gas, and||
0535|041|S|nausea may occur. If any of these effects last or get worse,||
0535|042|S|notify your doctor or pharmacist promptly.||
0535|043|S|   Remember that this medication has been prescribed because your||
0535|044|S|doctor has judged that the benefit to you is greater than the||
0535|045|S|risk of side effects. Many people using this medication do not||
0535|046|S|have serious side effects.||
0535|047|S|   Tell your doctor right away if you have any serious side||
0535|048|S|effects, including: an unusual feeling of fullness in the stomach||
0535|049|S|that doesn't go away, nausea/vomiting/stomach pain especially||
0535|050|S|after meals.||
0535|051|S|   A very serious allergic reaction to this drug is rare.||
0535|052|S|However, get medical help right away if you notice any symptoms||
0535|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0535|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0535|055|S|breathing.||
0535|056|S|   This is not a complete list of possible side effects. If you||
0535|057|S|notice other effects not listed above, contact your doctor or||
0535|058|S|pharmacist.||
0535|059|S|   In the US -||
0535|060|S|   Call your doctor for medical advice about side effects. You||
0535|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0535|062|S|www.fda.gov/medwatch.||
0535|063|S|   In Canada - Call your doctor for medical advice about side||
0535|064|S|effects. You may report side effects to Health Canada at||
0535|065|S|1-866-234-2345.||
0535|066|B|||
0535|067|P|PRECAUTIONS:  Before taking sucralfate, tell your doctor or||
0535|068|P|pharmacist if you are allergic to it; or if you have any other||
0535|069|P|allergies. This product may contain inactive ingredients, which||
0535|070|P|can cause allergic reactions or other problems. Talk to your||
0535|071|P|pharmacist for more details.||
0535|072|P|   Before using this medication, tell your doctor or pharmacist||
0535|073|P|your medical history, especially of: kidney problems,||
0535|074|P|stomach/intestine problems (such as delayed gastric emptying),||
0535|075|P|tube feeding.||
0535|076|P|   Before having surgery, tell your doctor or dentist about all||
0535|077|P|the products you use (including prescription drugs,||
0535|078|P|nonprescription drugs, and herbal products).||
0535|079|P|   Older adults may be at greater risk for developing high||
0535|080|P|aluminum levels while using this drug with other products that||
0535|081|P|contain aluminum (such as antacids).||
0535|082|P|   If you are pregnant, tell your doctor before using sucralfate.||
0535|083|P|   It is unknown if this medication passes into breast milk.||
0535|084|P|Consult your doctor before breastfeeding.||
0535|085|B|||
0535|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0535|087|I|medications work or increase your risk for serious side effects.||
0535|088|I|This document does not contain all possible drug interactions.||
0535|089|I|Keep a list of all the products you use (including||
0535|090|I|prescription/nonprescription drugs and herbal products) and share||
0535|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
0535|092|I|the dosage of any medicines without your doctor's approval.||
0535|093|I|   Some products that may interact with this drug include:||
0535|094|I|antacids that contain aluminum, certain antibiotics (including||
0535|095|I|quinolones such as ciprofloxacin/levofloxacin/ofloxacin,||
0535|096|I|tetracyclines), digoxin, ketoconazole, levoketoconazole,||
0535|097|I|penicillamine, phenytoin, quinidine, thyroid medications (such as||
0535|098|I|levothyroxine, liothyronine).||
0535|099|B|||
0535|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0535|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0535|102|O|poison control center right away. US residents can call||
0535|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0535|104|B|||
0535|105|N|NOTES:  Your doctor may recommend some lifestyle changes such as||
0535|106|N|stress-reducing programs, diet changes and exercise to assist in||
0535|107|N|treatment and prevention of ulcers. This medicine should not be||
0535|108|N|injected into your veins. Do not share this medication with||
0535|109|N|others.||
0535|110|B|||
0535|111|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0535|112|D|remember. If it is near the time of the next dose, skip the||
0535|113|D|missed dose. Take your next dose at the regular time. Do not||
0535|114|D|double the dose to catch up.||
0535|115|B|||
0535|116|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
0535|117|R|medications away from children and pets.||
0535|118|R|   Do not flush medications down the toilet or pour them into a||
0535|119|R|drain unless instructed to do so. Properly discard this product||
0535|120|R|when it is expired or no longer needed. Consult your pharmacist||
0535|121|R|or local waste disposal company.||
0535|122|B|||
0535|123|A|Information last revised October 2024.||
0535|124|A|Copyright(c) 2025 First Databank, Inc.||
0535|125|B|||
0536|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0536|002|Z|does NOT have all possible information about this product. This||
0536|003|Z|information does not assure that this product is safe, effective,||
0536|004|Z|or appropriate for you. This information is not individual||
0536|005|Z|medical advice and does not substitute for the advice of your||
0536|006|Z|health care professional. Always ask your health care||
0536|007|Z|professional for complete information about this product and your||
0536|008|Z|specific health needs.||
0536|009|B|||
0536|010|T|PEMETREXED - INJECTION||
0536|011|F|(PEM-e-TREX-ed)||
0536|012|B|||
0536|013|C|COMMON BRAND NAME(S): Alimta, Pemrydi RTU||
0536|014|B|||
0536|015|U|USES:  Pemetrexed is used to treat certain types of cancer (such||
0536|016|U|as lung cancer, mesothelioma). It is a chemotherapy drug that||
0536|017|U|works by slowing or stopping the growth of cancer cells.||
0536|018|B|||
0536|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0536|020|H|from your pharmacist before you start receiving pemetrexed and||
0536|021|H|each time you receive a dose. If you have any questions, ask your||
0536|022|H|doctor or pharmacist.||
0536|023|H|   This medication is given by injection into a vein by a||
0536|024|H|healthcare professional. It is given over 10 minutes as directed||
0536|025|H|by your doctor, usually once every 3 weeks. The dosage is based||
0536|026|H|on your medical condition, body size, and response to treatment.||
0536|027|H|To lower your chance of having a skin reaction while using||
0536|028|H|pemetrexed, your doctor will prescribe a corticosteroid medicine||
0536|029|H|(such as dexamethasone) to take for a short period around the||
0536|030|H|time of each treatment. Consult your doctor or pharmacist for||
0536|031|H|more details.||
0536|032|H|   To lower your chance of other side effects, it is very||
0536|033|H|important that you take folic acid vitamins and receive vitamin||
0536|034|H|B12 shots before and during treatment with pemetrexed. Folic acid||
0536|035|H|vitamins are available over-the-counter without a prescription,||
0536|036|H|and folic acid can be found in many multivitamin products. Make||
0536|037|H|sure your vitamin contains between 400 to 1000 micrograms (0.4 to||
0536|038|H|1 milligram) of folic acid. Take folic acid daily starting 1 week||
0536|039|H|before your first dose of pemetrexed, during treatment, and for 3||
0536|040|H|weeks after your last dose of pemetrexed. If you need help||
0536|041|H|choosing a folic acid vitamin, ask your doctor or pharmacist.||
0536|042|H|Your doctor will give you a vitamin B12 shot into the muscle,||
0536|043|H|usually 1 week before your first dose of pemetrexed and then once||
0536|044|H|every 9 weeks during your treatment. Do not substitute vitamin||
0536|045|H|B12 taken by mouth for the vitamin B12 shots. Consult your doctor||
0536|046|H|or pharmacist for more details.||
0536|047|B|||
0536|048|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, diarrhea,||
0536|049|S|stomach upset, changes in taste, constipation, mouth sores, and||
0536|050|S|tiredness may occur. Nausea, vomiting, and diarrhea can be||
0536|051|S|severe. In some cases, your doctor may prescribe medication to||
0536|052|S|prevent or relieve nausea, vomiting, and diarrhea. Eating several||
0536|053|S|small meals, not eating before treatment, or limiting activity||
0536|054|S|may help lessen nausea and vomiting. If any of these effects last||
0536|055|S|or get worse, tell your doctor or pharmacist promptly.||
0536|056|S|   Temporary hair loss may occur. Normal hair growth should||
0536|057|S|return after treatment has ended.||
0536|058|S|   People using this medication may have serious side effects.||
0536|059|S|However, you have been prescribed this drug because your doctor||
0536|060|S|has judged that the benefit to you is greater than the risk of||
0536|061|S|side effects. Careful monitoring by your doctor may decrease your||
0536|062|S|risk.||
0536|063|S|   Tell your doctor right away if you have any serious side||
0536|064|S|effects, including: numbness/tingling skin, swelling||
0536|065|S|ankles/feet/hands, signs of kidney problems (such as change in||
0536|066|S|the amount of urine), signs of liver disease (such as||
0536|067|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
0536|068|S|yellowing eyes/skin, dark urine).||
0536|069|S|   This medication may decrease bone marrow function, an effect||
0536|070|S|that may lead to a low number of blood cells such as red cells,||
0536|071|S|white cells, and platelets. This effect can cause anemia,||
0536|072|S|decrease your body's ability to fight an infection, or cause easy||
0536|073|S|bruising/bleeding. Tell your doctor right away if you develop any||
0536|074|S|of the following symptoms: unusual tiredness, pale skin, signs of||
0536|075|S|infection (such as sore throat that doesn't go away, fever,||
0536|076|S|chills), easy bruising/bleeding.||
0536|077|S|   Get medical help right away if you have any very serious side||
0536|078|S|effects, including: blisters or sores, signs of lung problems||
0536|079|S|(such as new or worsening shortness of breath, cough).||
0536|080|S|   Pemetrexed may cause a serious skin reaction that looks like a||
0536|081|S|severe sunburn (radiation recall) on any area that has been||
0536|082|S|treated with radiation weeks to years before. Get medical help||
0536|083|S|right away if you have skin redness, pain, tenderness, swelling,||
0536|084|S|peeling, or blisters.||
0536|085|S|   A very serious allergic reaction to this drug is rare.||
0536|086|S|However, get medical help right away if you notice any symptoms||
0536|087|S|of a serious allergic reaction, including: rash, itching/swelling||
0536|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0536|089|S|breathing.||
0536|090|S|   Pemetrexed can commonly cause a rash that is usually not||
0536|091|S|serious and that can be prevented by taking corticosteroid||
0536|092|S|medication (see How to Use section). However, you may not be able||
0536|093|S|to tell the rash apart from a rare rash that could be a sign of a||
0536|094|S|severe reaction. Get medical help right away if you develop any||
0536|095|S|rash.||
0536|096|S|   This is not a complete list of possible side effects. If you||
0536|097|S|notice other effects not listed above, contact your doctor or||
0536|098|S|pharmacist.||
0536|099|S|   In the US -||
0536|100|S|   Call your doctor for medical advice about side effects. You||
0536|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0536|102|S|www.fda.gov/medwatch.||
0536|103|S|   In Canada - Call your doctor for medical advice about side||
0536|104|S|effects. You may report side effects to Health Canada at||
0536|105|S|1-866-234-2345.||
0536|106|B|||
0536|107|P|PRECAUTIONS:  Before using pemetrexed, tell your doctor or||
0536|108|P|pharmacist if you are allergic to it; or if you have any other||
0536|109|P|allergies. This product may contain inactive ingredients, which||
0536|110|P|can cause allergic reactions or other problems. Talk to your||
0536|111|P|pharmacist for more details.||
0536|112|P|   Before using this medication, tell your doctor or pharmacist||
0536|113|P|your medical history, especially of: kidney disease, liver||
0536|114|P|disease, radiation treatment.||
0536|115|P|   Pemetrexed can make you more likely to get infections or may||
0536|116|P|make current infections worse. Stay away from anyone who has an||
0536|117|P|infection that may easily spread (such as chickenpox, COVID-19,||
0536|118|P|measles, flu). Talk to your doctor if you have been exposed to an||
0536|119|P|infection or for more details.||
0536|120|P|   Tell your health care professional that you are using||
0536|121|P|pemetrexed before having any immunizations/vaccinations. Avoid||
0536|122|P|contact with people who have recently received live vaccines||
0536|123|P|(such as flu vaccine inhaled through the nose).||
0536|124|P|   To lower the chance of getting cut, bruised, or injured, use||
0536|125|P|caution with sharp objects like razors and nail cutters, and||
0536|126|P|avoid activities such as contact sports.||
0536|127|P|   Before having surgery, tell your doctor or dentist about all||
0536|128|P|the products you use (including prescription drugs,||
0536|129|P|nonprescription drugs, and herbal products).||
0536|130|P|   This medication can affect fertility in males. Ask your doctor||
0536|131|P|for more details.||
0536|132|P|   Tell your doctor if you are pregnant or plan to become||
0536|133|P|pregnant. You should not become pregnant while using pemetrexed.||
0536|134|P|Pemetrexed may harm an unborn baby. Your doctor should order a||
0536|135|P|pregnancy test before you start this medication. Women using this||
0536|136|P|medication should ask about reliable forms of birth control||
0536|137|P|during treatment and for 6 months after the last dose. Men using||
0536|138|P|this medication should ask about reliable forms of birth control||
0536|139|P|during treatment and for 3 months after the last dose. If you or||
0536|140|P|your partner becomes pregnant, talk to your doctor right away||
0536|141|P|about the risks and benefits of this medication.||
0536|142|P|   It is unknown if this drug passes into breast milk. Because of||
0536|143|P|the possible risk to the infant, breastfeeding is not recommended||
0536|144|P|while using this drug and for 1 week after the last dose. Consult||
0536|145|P|your doctor before breastfeeding.||
0536|146|B|||
0536|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0536|148|I|medications work or increase your risk for serious side effects.||
0536|149|I|This document does not contain all possible drug interactions.||
0536|150|I|Keep a list of all the products you use (including||
0536|151|I|prescription/nonprescription drugs and herbal products) and share||
0536|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
0536|153|I|the dosage of any medicines without your doctor's approval.||
0536|154|B|||
0536|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0536|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0536|157|O|poison control center right away. US residents can call||
0536|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0536|159|B|||
0536|160|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0536|161|N|liver/kidney function) should be done while you are taking this||
0536|162|N|medication. Keep all medical and lab appointments. Consult your||
0536|163|N|doctor for more details.||
0536|164|B|||
0536|165|D|MISSED DOSE:  It is important to get each dose of this medication||
0536|166|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0536|167|D|right away for a new dosing schedule.||
0536|168|B|||
0536|169|R|STORAGE:  Not applicable. This medication is given in a clinic||
0536|170|R|and will not be stored at home.||
0536|171|B|||
0536|172|M|MEDICAL ALERT:  Your condition can cause complications in a||
0536|173|M|medical emergency. For information about enrolling in MedicAlert,||
0536|174|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0536|175|B|||
0536|176|A|Information last revised May 2024.||
0536|177|A|Copyright(c) 2025 First Databank, Inc.||
0536|178|B|||
0539|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0539|002|Z|does NOT have all possible information about this product. This||
0539|003|Z|information does not assure that this product is safe, effective,||
0539|004|Z|or appropriate for you. This information is not individual||
0539|005|Z|medical advice and does not substitute for the advice of your||
0539|006|Z|health care professional. Always ask your health care||
0539|007|Z|professional for complete information about this product and your||
0539|008|Z|specific health needs.||
0539|009|B|||
0539|010|T|CANDESARTAN/HYDROCHLOROTHIAZIDE - ORAL||
0539|011|F|(KAN-de-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)||
0539|012|B|||
0539|013|C|COMMON BRAND NAME(S): Atacand HCT||
0539|014|B|||
0539|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
0539|016|W|unborn baby if used during pregnancy. It is important to prevent||
0539|017|W|pregnancy while taking this medication. Consult your doctor for||
0539|018|W|more details and to discuss the use of reliable forms of birth||
0539|019|W|control while taking this medication. If you are planning||
0539|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
0539|021|W|your doctor right away.||
0539|022|B|||
0539|023|U|USES:  This medication is used to treat high blood pressure||
0539|024|U|(hypertension). Lowering high blood pressure helps prevent||
0539|025|U|strokes, heart attacks, and kidney problems. This product||
0539|026|U|contains 2 medications: candesartan and hydrochlorothiazide.||
0539|027|U|Candesartan belongs to a class of drugs called angiotensin||
0539|028|U|receptor blockers (ARBs). It works by relaxing blood vessels so||
0539|029|U|blood can flow more easily. Hydrochlorothiazide is a "water pill"||
0539|030|U|(diuretic). It increases the amount of urine you make, especially||
0539|031|U|when you first start the medication. It also helps to relax the||
0539|032|U|blood vessels so that blood can flow more easily.||
0539|033|U|   These medications are used together when 1 drug alone is not||
0539|034|U|controlling your blood pressure. Your doctor may direct you to||
0539|035|U|start taking the individual medications first, and then switch||
0539|036|U|you over to this combination product if this is the best dose||
0539|037|U|combination for you.||
0539|038|B|||
0539|039|V|OTHER USES:  This section contains uses of this drug that are not||
0539|040|V|listed in the approved professional labeling for the drug but||
0539|041|V|that may be prescribed by your health care professional. Use this||
0539|042|V|drug for a condition that is listed in this section only if it||
0539|043|V|has been so prescribed by your health care professional.||
0539|044|V|   This drug may also be used for heart failure.||
0539|045|B|||
0539|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0539|047|H|from your pharmacist before you start taking||
0539|048|H|candesartan/hydrochlorothiazide and each time you get a refill.||
0539|049|H|If you have any questions, ask your doctor or pharmacist.||
0539|050|H|   Take this medication by mouth with or without food as directed||
0539|051|H|by your doctor, usually once daily. It is best to avoid taking||
0539|052|H|this medication within 4 hours of your bedtime to avoid having to||
0539|053|H|get up to urinate. Consult your doctor or pharmacist if you have||
0539|054|H|questions about your dosing schedule.||
0539|055|H|   The dosage is based on your medical condition and response to||
0539|056|H|treatment.||
0539|057|H|   Use this medication regularly to get the most benefit from it.||
0539|058|H|To help you remember, take it at the same time each day. Keep||
0539|059|H|taking this medication even if you feel well. Most people with||
0539|060|H|high blood pressure do not feel sick. It may take up to 4 weeks||
0539|061|H|before you get the full benefit of this drug.||
0539|062|H|   If you also take certain drugs to lower your cholesterol (bile||
0539|063|H|acid-binding resins such as cholestyramine or colestipol), take||
0539|064|H|this product at least 4 hours before or at least 4 to 6 hours||
0539|065|H|after these medications.||
0539|066|H|   Tell your doctor if your condition does not get better or if||
0539|067|H|it gets worse (your blood pressure readings remain high or||
0539|068|H|increase).||
0539|069|B|||
0539|070|S|SIDE EFFECTS:  Dizziness and lightheadedness may occur as your||
0539|071|S|body adjusts to the medication. If either of these effects lasts||
0539|072|S|or gets worse, tell your doctor or pharmacist promptly.||
0539|073|S|   To reduce the risk of dizziness and lightheadedness, get up||
0539|074|S|slowly when rising from a sitting or lying position.||
0539|075|S|   Remember that this medication has been prescribed because your||
0539|076|S|doctor has judged that the benefit to you is greater than the||
0539|077|S|risk of side effects. Many people using this medication do not||
0539|078|S|have serious side effects.||
0539|079|S|   This product may cause dehydration and electrolyte imbalance.||
0539|080|S|Tell your doctor right away if you have any symptoms of||
0539|081|S|dehydration or electrolyte imbalance, including unusual dry||
0539|082|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0539|083|S|heartbeat, or confusion.||
0539|084|S|   Tell your doctor right away if you have any serious side||
0539|085|S|effects, including: fainting, signs of kidney problems (such as||
0539|086|S|change in the amount of urine), toe/joint pain, decrease in||
0539|087|S|vision, eye pain.||
0539|088|S|   A very serious allergic reaction to this drug is rare.||
0539|089|S|However, get medical help right away if you notice any symptoms||
0539|090|S|of a serious allergic reaction, including: rash, itching/swelling||
0539|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0539|092|S|breathing.||
0539|093|S|   This is not a complete list of possible side effects. If you||
0539|094|S|notice other effects not listed above, contact your doctor or||
0539|095|S|pharmacist.||
0539|096|S|   In the US -||
0539|097|S|   Call your doctor for medical advice about side effects. You||
0539|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0539|099|S|www.fda.gov/medwatch.||
0539|100|S|   In Canada - Call your doctor for medical advice about side||
0539|101|S|effects. You may report side effects to Health Canada at||
0539|102|S|1-866-234-2345.||
0539|103|B|||
0539|104|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0539|105|P|pharmacist if you are allergic to candesartan or||
0539|106|P|hydrochlorothiazide; or if you have any other allergies. This||
0539|107|P|product may contain inactive ingredients, which can cause||
0539|108|P|allergic reactions or other problems. Talk to your pharmacist for||
0539|109|P|more details.||
0539|110|P|   Before using this medication, tell your doctor or pharmacist||
0539|111|P|your medical history, especially of: kidney disease (such as||
0539|112|P|renal artery stenosis), liver disease, dehydration, untreated||
0539|113|P|electrolytes imbalance (such as low or high potassium), gout,||
0539|114|P|lupus, skin cancer.||
0539|115|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0539|116|P|can make you more dizzy. Do not drive, use machinery, or do||
0539|117|P|anything that needs alertness until you can do it safely. Limit||
0539|118|P|alcoholic beverages. Talk to your doctor if you are using||
0539|119|P|marijuana (cannabis).||
0539|120|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0539|121|P|and cause you to feel lightheaded. Tell your doctor if you have||
0539|122|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0539|123|P|of fluids unless your doctor tells you not to.||
0539|124|P|   Before having surgery, tell your doctor or dentist about all||
0539|125|P|the products you use (including prescription drugs,||
0539|126|P|nonprescription drugs, and herbal products).||
0539|127|P|   If you have diabetes, this medication may affect your blood||
0539|128|P|sugar. Check your blood sugar regularly as directed and share the||
0539|129|P|results with your doctor. Tell your doctor right away if you have||
0539|130|P|symptoms of high blood sugar such as increased thirst/urination.||
0539|131|P|Your doctor may need to adjust your diabetes medication, exercise||
0539|132|P|program, or diet.||
0539|133|P|   This drug may affect your potassium levels. Before using||
0539|134|P|potassium supplements or salt substitutes that contain potassium,||
0539|135|P|consult your doctor or pharmacist.||
0539|136|P|   This medication may make you more sensitive to the sun. It may||
0539|137|P|also increase your risk for skin cancer, especially if you take||
0539|138|P|it for a long time. Limit your time in the sun. Avoid tanning||
0539|139|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0539|140|P|when outdoors. Tell your doctor right away if you get sunburned,||
0539|141|P|have skin blisters/redness, or notice new or changed moles/skin||
0539|142|P|lesions.||
0539|143|P|   Older adults may be more sensitive to the side effects of this||
0539|144|P|drug, especially dizziness and change in the amount of urine||
0539|145|P|(kidney problems).||
0539|146|P|   Tell your doctor if you are pregnant or plan to become||
0539|147|P|pregnant. You should not become pregnant while using this||
0539|148|P|medication. Candesartan may harm an unborn baby. If you become||
0539|149|P|pregnant, talk to your doctor right away about the risks and||
0539|150|P|benefits of this medication. (See also Warning section.)||
0539|151|P|   This drug passes into breast milk. Consult your doctor before||
0539|152|P|breastfeeding.||
0539|153|B|||
0539|154|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
0539|155|I|   Drug interactions may change how your medications work or||
0539|156|I|increase your risk for serious side effects. This document does||
0539|157|I|not contain all possible drug interactions. Keep a list of all||
0539|158|I|the products you use (including prescription/nonprescription||
0539|159|I|drugs and herbal products) and share it with your doctor and||
0539|160|I|pharmacist. Do not start, stop, or change the dosage of any||
0539|161|I|medicines without your doctor's approval.||
0539|162|I|   Some products that may interact with this drug include:||
0539|163|I|aliskiren, dofetilide, lithium, drugs that may increase the level||
0539|164|I|of potassium in the blood (such as sparsentan, ACE inhibitors||
0539|165|I|including benazepril/lisinopril, birth control pills containing||
0539|166|I|drospirenone).||
0539|167|I|   Some products have ingredients that could raise your blood||
0539|168|I|pressure or worsen your heart failure. Tell your pharmacist what||
0539|169|I|products you are using, and ask how to use them safely||
0539|170|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0539|171|I|ibuprofen/naproxen).||
0539|172|I|   This medication may interfere with certain lab tests (such as||
0539|173|I|parathyroid test, protein-bound iodide test), possibly causing||
0539|174|I|false test results. Make sure lab personnel and all your doctors||
0539|175|I|know you use this drug.||
0539|176|B|||
0539|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0539|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0539|179|O|poison control center right away. US residents can call||
0539|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0539|181|O|Symptoms of overdose may include: fast heartbeat, severe||
0539|182|O|dizziness, fainting.||
0539|183|B|||
0539|184|N|NOTES:  Do not share this medication with others.||
0539|185|N|   Lab and/or medical tests (such as kidney function, blood||
0539|186|N|mineral levels including potassium, skin exams, cholesterol||
0539|187|N|levels) should be done while you are taking this medication. Keep||
0539|188|N|all medical and lab appointments. Consult your doctor for more||
0539|189|N|details.||
0539|190|N|   Lifestyle changes that may help this medication work better||
0539|191|N|include stress reduction programs, exercise, and dietary changes.||
0539|192|N|Talk to your doctor or pharmacist about lifestyle changes that||
0539|193|N|might benefit you.||
0539|194|N|   Have your blood pressure checked regularly while taking this||
0539|195|N|medication. Learn how to monitor your own blood pressure at home,||
0539|196|N|and share the results with your doctor.||
0539|197|B|||
0539|198|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0539|199|D|remember. If it is near the time of the next dose, skip the||
0539|200|D|missed dose. Take your next dose at the regular time. Do not||
0539|201|D|double the dose to catch up.||
0539|202|B|||
0539|203|R|STORAGE:  Store at room temperature away from light and moisture.||
0539|204|R|Do not store in the bathroom. Keep all medications away from||
0539|205|R|children and pets.||
0539|206|R|   Do not flush medications down the toilet or pour them into a||
0539|207|R|drain unless instructed to do so. Properly discard this product||
0539|208|R|when it is expired or no longer needed. Consult your pharmacist||
0539|209|R|or local waste disposal company.||
0539|210|B|||
0539|211|A|Information last revised March 2025.||
0539|212|A|Copyright(c) 2025 First Databank, Inc.||
0539|213|B|||
0540|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0540|002|Z|does NOT have all possible information about this product. This||
0540|003|Z|information does not assure that this product is safe, effective,||
0540|004|Z|or appropriate for you. This information is not individual||
0540|005|Z|medical advice and does not substitute for the advice of your||
0540|006|Z|health care professional. Always ask your health care||
0540|007|Z|professional for complete information about this product and your||
0540|008|Z|specific health needs.||
0540|009|B|||
0540|010|T|MULTIVITAMIN/FOLIC ACID/SELECTED MINERALS - ORAL||
0540|011|F|(mull-tee-VYE-tah-min/FOE-lick A-sid/Selected Minerals)||
0540|012|B|||
0540|013|U|USES:  This combination of vitamins and selected minerals is used||
0540|014|U|to prevent or treat vitamin deficiency due to poor eating habits,||
0540|015|U|problems that affect the body's ability to absorb nutrition from||
0540|016|U|food, or increased need for vitamins and minerals due to stress||
0540|017|U|or illness. Vitamins are needed for the body to function well.||
0540|018|U|   This vitamin/mineral combination contains high levels of B||
0540|019|U|vitamins (such as folic acid, niacin, B-1, B-2, B-6, and B-12)||
0540|020|U|and vitamin C. It also contains other vitamins (A, D, and E) and||
0540|021|U|minerals such as zinc. This medication does not contain iron and||
0540|022|U|has only a small amount of calcium. It should not be used to||
0540|023|U|treat "iron-poor" blood (anemia) or to prevent osteoporosis.||
0540|024|U|   This medication is not recommended for use in children under||
0540|025|U|12 because of increased risk of some vitamins/minerals building||
0540|026|U|up to harmful levels in the body.||
0540|027|B|||
0540|028|H|HOW TO USE:  Take this medication by mouth with or without food||
0540|029|H|as directed by your doctor, usually once or twice daily. If||
0540|030|H|stomach upset occurs, it may help to take this product with food.||
0540|031|B|||
0540|032|S|SIDE EFFECTS:  Nausea, stomach upset, diarrhea, flushing and||
0540|033|S|unpleasant taste may occur. If any of these effects last or get||
0540|034|S|worse, notify your doctor or pharmacist promptly.||
0540|035|S|   If your doctor has prescribed this medication, remember that||
0540|036|S|your doctor has judged that the benefit to you is greater than||
0540|037|S|the risk of side effects. Many people using this medication do||
0540|038|S|not have serious side effects.||
0540|039|S|   Tell your doctor right away if you have any serious side||
0540|040|S|effects, including: mental/mood changes, unusual weakness.||
0540|041|S|   A very serious allergic reaction to this drug is rare.||
0540|042|S|However, get medical help right away if you notice any symptoms||
0540|043|S|of a serious allergic reaction, including: rash, itching/swelling||
0540|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0540|045|S|breathing.||
0540|046|S|   This is not a complete list of possible side effects. If you||
0540|047|S|notice other effects not listed above, contact your doctor or||
0540|048|S|pharmacist.||
0540|049|S|   In the US -||
0540|050|S|   Call your doctor for medical advice about side effects. You||
0540|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0540|052|S|www.fda.gov/medwatch.||
0540|053|S|   In Canada - Call your doctor for medical advice about side||
0540|054|S|effects. You may report side effects to Health Canada at||
0540|055|S|1-866-234-2345.||
0540|056|B|||
0540|057|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0540|058|P|pharmacist if you are allergic to it; or to any of its||
0540|059|P|ingredients such as folic acid; or if you have any other||
0540|060|P|allergies. This product may contain inactive ingredients, which||
0540|061|P|can cause allergic reactions or other problems. Talk to your||
0540|062|P|pharmacist for more details.||
0540|063|P|   Before using this medication, tell your doctor or pharmacist||
0540|064|P|your medical history, especially of: low blood count (such as||
0540|065|P|pernicious anemia, megaloblastic anemia, vitamin B-12||
0540|066|P|deficiency), high calcium levels, kidney disease, liver disease.||
0540|067|P|   Before having surgery, tell your doctor or dentist about all||
0540|068|P|the products you use (including prescription drugs,||
0540|069|P|nonprescription drugs, and herbal products).||
0540|070|P|   During pregnancy, this medication should be used only when||
0540|071|P|clearly needed. Discuss the risks and benefits with your doctor.||
0540|072|P|   This drug passes into breast milk. Consult your doctor before||
0540|073|P|breastfeeding.||
0540|074|B|||
0540|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0540|076|I|medications work or increase your risk for serious side effects.||
0540|077|I|This document does not contain all possible drug interactions.||
0540|078|I|Keep a list of all the products you use (including||
0540|079|I|prescription/nonprescription drugs and herbal products) and share||
0540|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
0540|081|I|the dosage of any medicines without your doctor's approval.||
0540|082|I|   This product can decrease the absorption of certain drugs,||
0540|083|I|especially if you take them around the same time. These drugs||
0540|084|I|include bisphosphonates (such as alendronate), penicillamine,||
0540|085|I|quinolone antibiotics (such as ciprofloxacin, levofloxacin),||
0540|086|I|tetracycline antibiotics (such as doxycycline, minocycline),||
0540|087|I|thyroid medications (such as levothyroxine), among others. Ask||
0540|088|I|your doctor or pharmacist how long you should wait between doses||
0540|089|I|of this product and your other medications and to find a dosing||
0540|090|I|schedule that works for all your medications.||
0540|091|B|||
0540|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0540|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0540|094|O|poison control center right away. US residents can call||
0540|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0540|096|O|Symptoms of overuse may include: symptoms of liver disease (such||
0540|097|O|as nausea/vomiting that doesn't stop, dark urine,||
0540|098|O|stomach/abdominal pain, yellowing of eyes/skin), kidney disease||
0540|099|O|(such as back pain, painful urination, change in amount of||
0540|100|O|urine), bone pain, mental/mood changes, severe headache.||
0540|101|B|||
0540|102|N|NOTES:  Keep all medical and lab appointments.||
0540|103|N|   Remember that it is best to get your vitamins and minerals||
0540|104|N|from healthy foods. Maintain a well-balanced diet and follow any||
0540|105|N|dietary guidelines as directed by your doctor. B vitamins,||
0540|106|N|including folic acid, are naturally found in leafy greens and||
0540|107|N|other vegetables, and citrus fruits. You will also find folic||
0540|108|N|acid in enriched grains such as bread, pasta and cereal.||
0540|109|B|||
0540|110|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0540|111|D|If it is near the time of the next dose, skip the missed dose.||
0540|112|D|Use your next dose at the regular time. Do not double the dose to||
0540|113|D|catch up.||
0540|114|B|||
0540|115|R|STORAGE:  Store at room temperature away from light and moisture.||
0540|116|R|Keep all medications away from children and pets.||
0540|117|R|   Do not flush medications down the toilet or pour them into a||
0540|118|R|drain unless instructed to do so. Properly discard this product||
0540|119|R|when it is expired or no longer needed. Consult your pharmacist||
0540|120|R|or local waste disposal company.||
0540|121|B|||
0540|122|A|Information last revised October 2025.||
0540|123|A|Copyright(c) 2025 First Databank, Inc.||
0540|124|B|||
0541|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0541|002|Z|does NOT have all possible information about this product. This||
0541|003|Z|information does not assure that this product is safe, effective,||
0541|004|Z|or appropriate for you. This information is not individual||
0541|005|Z|medical advice and does not substitute for the advice of your||
0541|006|Z|health care professional. Always ask your health care||
0541|007|Z|professional for complete information about this product and your||
0541|008|Z|specific health needs.||
0541|009|B|||
0541|010|T|SODIUM HYPOCHLORITE SOLUTION - TOPICAL||
0541|011|F|(SO-dee-um hye-poeKLOR-ite)||
0541|012|B|||
0541|013|U|USES:  This product is used to prevent and treat skin and tissue||
0541|014|U|infections that could result from cuts, scrapes and pressure||
0541|015|U|sores. It is also used before and after surgery to prevent||
0541|016|U|surgical wound infections.||
0541|017|U|   Sodium hypochlorite solution is made from bleach that has been||
0541|018|U|diluted and treated to decrease irritation. Chlorine, the active||
0541|019|U|ingredient in this product, is a strong antiseptic that kills||
0541|020|U|most forms of bacteria and viruses.||
0541|021|B|||
0541|022|H|HOW TO USE:  Pour, apply or spray onto the injured area. When||
0541|023|H|used on wounds, this product can be poured onto the affected area||
0541|024|H|as an irrigation or cleanser. It is also used to wet certain||
0541|025|H|types of wound dressings (such as wet to moist dressing). Follow||
0541|026|H|your doctor's instructions exactly.||
0541|027|H|   The body's own wound-healing tissues and fluids can decrease||
0541|028|H|the antibacterial effect of this product. This solution is often||
0541|029|H|used only once daily for minor wounds and twice daily for heavily||
0541|030|H|draining or contaminated wounds. Use this product as directed by||
0541|031|H|your doctor.||
0541|032|H|   Protect the surrounding healthy skin with a moisture barrier||
0541|033|H|ointment (such as petroleum jelly) or skin sealant as needed to||
0541|034|H|prevent irritation.||
0541|035|H|   This product is for external use only. Do not swallow. Do not||
0541|036|H|use in eyes, ears, or nose. If the solution gets into the eyes,||
0541|037|H|flush the open eyes right away with clean water for at least 15||
0541|038|H|minutes.||
0541|039|H|   Tell your doctor if your condition does not get better or if||
0541|040|H|it gets worse.||
0541|041|B|||
0541|042|S|SIDE EFFECTS:  Redness, irritation, swelling, and pain may occur.||
0541|043|S|If any of these effects last or get worse, notify your doctor or||
0541|044|S|pharmacist promptly.||
0541|045|S|   If your doctor has directed you to use this product, remember||
0541|046|S|that your doctor has judged that the benefit to you is greater||
0541|047|S|than the risk of side effects. Many people using this product do||
0541|048|S|not have serious side effects.||
0541|049|S|   A very serious allergic reaction to this drug is rare.||
0541|050|S|However, get medical help right away if you notice any symptoms||
0541|051|S|of a serious allergic reaction, including: rash, itching/swelling||
0541|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0541|053|S|breathing.||
0541|054|S|   This is not a complete list of possible side effects. If you||
0541|055|S|notice other effects not listed above, contact your doctor or||
0541|056|S|pharmacist.||
0541|057|S|   In the US -||
0541|058|S|   Call your doctor for medical advice about side effects. You||
0541|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0541|060|S|www.fda.gov/medwatch.||
0541|061|S|   In Canada - Call your doctor for medical advice about side||
0541|062|S|effects. You may report side effects to Health Canada at||
0541|063|S|1-866-234-2345.||
0541|064|B|||
0541|065|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0541|066|P|pharmacist if you are allergic to it; or to any chlorine||
0541|067|P|compounds; or if you have any other allergies. This product may||
0541|068|P|contain inactive ingredients, which can cause allergic reactions||
0541|069|P|or other problems. Talk to your pharmacist for more details.||
0541|070|P|   If you have any health problems, consult your doctor or||
0541|071|P|pharmacist before using this product.||
0541|072|P|   Before having surgery, tell your doctor or dentist about all||
0541|073|P|the products you use (including prescription drugs,||
0541|074|P|nonprescription drugs, and herbal products).||
0541|075|P|   During pregnancy, this product should be used only when||
0541|076|P|clearly needed. Discuss the risks and benefits with your doctor.||
0541|077|P|   It is unknown if this product passes into breast milk. Consult||
0541|078|P|your doctor before breastfeeding.||
0541|079|B|||
0541|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0541|081|I|medications work or increase your risk for serious side effects.||
0541|082|I|This document does not contain all possible drug interactions.||
0541|083|I|Keep a list of all the products you use (including||
0541|084|I|prescription/nonprescription drugs and herbal products) and share||
0541|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
0541|086|I|the dosage of any medicines without your doctor's approval.||
0541|087|B|||
0541|088|O|OVERDOSE:  This product may be harmful if swallowed. If someone||
0541|089|O|has overdosed and has serious symptoms such as passing out or||
0541|090|O|trouble breathing, call 911. Otherwise, call a poison control||
0541|091|O|center right away. US residents can call 1-800-222-1222. Canada||
0541|092|O|residents can call 1-844-764-7669.||
0541|093|B|||
0541|094|N|NOTES:  Do not share this product with others.||
0541|095|N|   This product may bleach clothing and other items.||
0541|096|B|||
0541|097|D|MISSED DOSE:  Not applicable.||
0541|098|B|||
0541|099|R|STORAGE:  Store at room temperature. This product loses its||
0541|100|R|strength if frozen or stored at high temperature. Keep all||
0541|101|R|medications away from children and pets.||
0541|102|R|   Do not flush medications down the toilet or pour them into a||
0541|103|R|drain unless instructed to do so. Properly discard this product||
0541|104|R|when it is expired or no longer needed. Consult your pharmacist||
0541|105|R|or local waste disposal company.||
0541|106|B|||
0541|107|A|Information last revised August 2025.||
0541|108|A|Copyright(c) 2025 First Databank, Inc.||
0541|109|B|||
0542|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0542|002|Z|does NOT have all possible information about this product. This||
0542|003|Z|information does not assure that this product is safe, effective,||
0542|004|Z|or appropriate for you. This information is not individual||
0542|005|Z|medical advice and does not substitute for the advice of your||
0542|006|Z|health care professional. Always ask your health care||
0542|007|Z|professional for complete information about this product and your||
0542|008|Z|specific health needs.||
0542|009|B|||
0542|010|T|LOPINAVIR/RITONAVIR - ORAL||
0542|011|F|(loe-PIN-a-vir/ri-TOE-na-vir)||
0542|012|B|||
0542|013|C|COMMON BRAND NAME(S): Kaletra||
0542|014|B|||
0542|015|U|USES:  This combination product contains two medications:||
0542|016|U|lopinavir and ritonavir. This product is used with other HIV||
0542|017|U|medications to help control HIV infection. It helps to decrease||
0542|018|U|the amount of HIV in your body so your immune system can work||
0542|019|U|better. This lowers your chance of getting HIV complications||
0542|020|U|(such as new infections, cancer) and improves your quality of||
0542|021|U|life. Both lopinavir and ritonavir belong to a class of drugs||
0542|022|U|known as HIV protease inhibitors. Ritonavir increases ("boosts")||
0542|023|U|the levels of lopinavir. This helps lopinavir work better.||
0542|024|U|   Lopinavir/ritonavir is not a cure for HIV infection. To||
0542|025|U|decrease your risk of spreading HIV disease to others, continue||
0542|026|U|to take all HIV medications exactly as prescribed by your doctor.||
0542|027|U|Use an effective barrier method (latex or polyurethane||
0542|028|U|condoms/dental dams) during sexual activity as directed by your||
0542|029|U|doctor. Do not share personal items (such as needles/syringes,||
0542|030|U|toothbrushes, and razors) that may have contacted blood or other||
0542|031|U|body fluids. Consult your doctor or pharmacist for more details.||
0542|032|B|||
0542|033|V|OTHER USES:  This section contains uses of this drug that are not||
0542|034|V|listed in the approved professional labeling for the drug but||
0542|035|V|that may be prescribed by your health care professional. Use this||
0542|036|V|drug for a condition that is listed in this section only if it||
0542|037|V|has been so prescribed by your health care professional.||
0542|038|V|   This product may also be used to lessen the risk of HIV||
0542|039|V|infection after contact with the virus (for example, due to a||
0542|040|V|needle stick). Ask your doctor for more details.||
0542|041|B|||
0542|042|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0542|043|H|Patient Information Leaflet provided by your pharmacist before||
0542|044|H|you start taking lopinavir/ritonavir and each time you get a||
0542|045|H|refill. If you have any questions, ask your doctor or pharmacist.||
0542|046|H|   Take this medication by mouth with or without food as directed||
0542|047|H|by your doctor, usually once or twice daily. Swallow the tablets||
0542|048|H|whole. Do not crush, break or chew the tablets.||
0542|049|H|   The dosage is based on your medical condition, response to||
0542|050|H|treatment, and other medications you may be taking. Be sure to||
0542|051|H|tell your doctor and pharmacist about all the products you use||
0542|052|H|(including prescription drugs, nonprescription drugs, and herbal||
0542|053|H|products).||
0542|054|H|   Children's dosage is also based on age and body size.||
0542|055|H|Once-daily dosing of this medication is not recommended for||
0542|056|H|children younger than 18 years of age.||
0542|057|H|   If you are taking didanosine in addition to this product, you||
0542|058|H|can take it at the same time as this product, but take them both||
0542|059|H|without food.||
0542|060|H|   It is very important to keep taking this medication (and other||
0542|061|H|HIV medications) exactly as prescribed by your doctor. Do not||
0542|062|H|skip any doses.||
0542|063|H|   For the best effect, take this medication at evenly spaced||
0542|064|H|times. To help you remember, take this medication at the same||
0542|065|H|time(s) every day.||
0542|066|H|   Do not take more or less of this drug than prescribed or stop||
0542|067|H|taking it (or other HIV medicines) even for a short time unless||
0542|068|H|directed to do so by your doctor. Doing so may cause the amount||
0542|069|H|of virus to increase, make the infection more difficult to treat||
0542|070|H|(resistant), or worsen side effects.||
0542|071|B|||
0542|072|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, stomach upset, gas,||
0542|073|S|headache, and trouble sleeping may occur. If any of these effects||
0542|074|S|last or get worse, tell your doctor or pharmacist promptly.||
0542|075|S|   Remember that this medication has been prescribed because your||
0542|076|S|doctor has judged that the benefit to you is greater than the||
0542|077|S|risk of side effects. Many people using this medication do not||
0542|078|S|have serious side effects.||
0542|079|S|   As your immune system gets stronger, it can begin to fight off||
0542|080|S|infections you already had, possibly causing disease symptoms to||
0542|081|S|come back. You could also have symptoms if your immune system||
0542|082|S|becomes overactive. This reaction may happen at any time (soon||
0542|083|S|after starting HIV treatment or many months later). Tell your||
0542|084|S|doctor right away if you have any serious symptoms, including:||
0542|085|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
0542|086|S|that doesn't go away, headaches that are severe or don't go away,||
0542|087|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
0542|088|S|changes, signs of infection (such as sore throat that doesn't go||
0542|089|S|away, fever, chills, swollen lymph nodes, non-healing skin||
0542|090|S|sores), signs of an overactive thyroid (such as irritability,||
0542|091|S|nervousness, heat intolerance, fast/pounding/irregular||
0542|092|S|heartbeat).||
0542|093|S|   Tell your doctor right away if you have any serious side||
0542|094|S|effects, including: nausea/vomiting that doesn't stop, increased||
0542|095|S|thirst, increased urination, confusion, stomach/abdominal pain,||
0542|096|S|yellowing eyes/skin, dark urine.||
0542|097|S|   Get medical help right away if you have any very serious side||
0542|098|S|effects, including: symptoms of a heart attack (such as||
0542|099|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
0542|100|S|severe dizziness, fainting, slow/fast/irregular heartbeat.||
0542|101|S|   Changes in body fat may occur while you are taking this||
0542|102|S|medication (such as increased fat in the upper back and stomach||
0542|103|S|areas, decreased fat in the arms and legs). The cause and||
0542|104|S|long-term effects of these changes are unknown. Discuss the risks||
0542|105|S|and benefits of treatment with your doctor, as well as the||
0542|106|S|possible use of exercise to reduce this side effect.||
0542|107|S|   This medication may cause an increase in blood fat levels||
0542|108|S|(cholesterol and triglycerides). Cholesterol and triglyceride||
0542|109|S|testing should be done before and occasionally during treatment||
0542|110|S|with this medication. Consult your doctor or pharmacist for more||
0542|111|S|information.||
0542|112|S|   A very serious allergic reaction to this drug is rare.||
0542|113|S|However, get medical help right away if you notice any symptoms||
0542|114|S|of a serious allergic reaction, including: rash, itching/swelling||
0542|115|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0542|116|S|breathing.||
0542|117|S|   This is not a complete list of possible side effects. If you||
0542|118|S|notice other effects not listed above, contact your doctor or||
0542|119|S|pharmacist.||
0542|120|S|   In the US -||
0542|121|S|   Call your doctor for medical advice about side effects. You||
0542|122|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0542|123|S|www.fda.gov/medwatch.||
0542|124|S|   In Canada - Call your doctor for medical advice about side||
0542|125|S|effects. You may report side effects to Health Canada at||
0542|126|S|1-866-234-2345.||
0542|127|B|||
0542|128|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0542|129|P|pharmacist if you are allergic to either lopinavir or ritonavir;||
0542|130|P|or if you have any other allergies. This product may contain||
0542|131|P|inactive ingredients, which can cause allergic reactions or other||
0542|132|P|problems. Talk to your pharmacist for more details.||
0542|133|P|   Before using this medication, tell your doctor or pharmacist||
0542|134|P|your medical history, especially of: liver disease, diabetes,||
0542|135|P|pancreatitis, high blood fat levels (cholesterol/triglycerides),||
0542|136|P|heart problems (coronary artery disease, heart attack), bleeding||
0542|137|P|problems (such as hemophilia), previous infection with certain||
0542|138|P|diseases (such as hepatitis B infection, hepatitis C infection,||
0542|139|P|tuberculosis).||
0542|140|P|   Lopinavir/ritonavir may cause a condition that affects the||
0542|141|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
0542|142|P|serious (rarely fatal) fast/irregular heartbeat and other||
0542|143|P|symptoms (such as severe dizziness, fainting) that need medical||
0542|144|P|attention right away.||
0542|145|P|   The risk of QT prolongation may be increased if you have||
0542|146|P|certain medical conditions or are taking other drugs that may||
0542|147|P|cause QT prolongation. Before using lopinavir/ritonavir, tell||
0542|148|P|your doctor or pharmacist of all the drugs you take and if you||
0542|149|P|have any of the following conditions: certain heart problems||
0542|150|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
0542|151|P|family history of certain heart problems (QT prolongation in the||
0542|152|P|EKG, sudden cardiac death).||
0542|153|P|   Low levels of potassium or magnesium in the blood may also||
0542|154|P|increase your risk of QT prolongation. This risk may increase if||
0542|155|P|you use certain drugs (such as diuretics/"water pills") or if you||
0542|156|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0542|157|P|Talk to your doctor about using lopinavir/ritonavir safely.||
0542|158|P|   Before having surgery, tell your doctor or dentist about all||
0542|159|P|the products you use (including prescription drugs,||
0542|160|P|nonprescription drugs, and herbal products).||
0542|161|P|   Older adults may be more sensitive to the side effects of this||
0542|162|P|drug, especially QT prolongation (see above).||
0542|163|P|   Tell your doctor if you are pregnant before using this||
0542|164|P|medication. Treatment can lower the risk of passing HIV infection||
0542|165|P|to your baby. Discuss the risks and benefits with your doctor.||
0542|166|P|   This medication passes into breast milk. Because breast milk||
0542|167|P|may transmit HIV, consult your doctor before breastfeeding.||
0542|168|B|||
0542|169|I|DRUG INTERACTIONS:  See also How to Use section.||
0542|170|I|   Drug interactions may change how your medications work or||
0542|171|I|increase your risk for serious side effects. This document does||
0542|172|I|not contain all possible drug interactions. Keep a list of all||
0542|173|I|the products you use (including prescription/nonprescription||
0542|174|I|drugs and herbal products) and share it with your doctor and||
0542|175|I|pharmacist. Do not start, stop, or change the dosage of any||
0542|176|I|medicines without your doctor's approval.||
0542|177|I|   Lopinavir/ritonavir interacts with many medications. Some||
0542|178|I|products that may interact with this drug include: cobicistat,||
0542|179|I|certain HIV medications (such as fosamprenavir, tipranavir),||
0542|180|I|orlistat.||
0542|181|I|   Other medications can affect the removal of||
0542|182|I|lopinavir/ritonavir from your body, which may affect how||
0542|183|I|lopinavir/ritonavir works. Examples include apalutamide,||
0542|184|I|rifampin, St. John's wort, among others.||
0542|185|I|   Lopinavir/ritonavir can speed up or slow down the removal of||
0542|186|I|other medications from your body, which may affect how they work.||
0542|187|I|Examples of affected drugs include certain alpha blockers (such||
0542|188|I|as alfuzosin, tamsulosin), certain inhaled drugs to treat||
0542|189|I|breathing problems (such as fluticasone, salmeterol), drugs to||
0542|190|I|treat erectile dysfunction-ED or pulmonary hypertension (such as||
0542|191|I|sildenafil, tadalafil), ergot drugs (such as ergotamine,||
0542|192|I|dihydroergotamine), pimozide, rivaroxaban, certain sedatives||
0542|193|I|(such as midazolam, triazolam), certain statins (such as||
0542|194|I|lovastatin, simvastatin), among others.||
0542|195|I|   This medication may decrease the effectiveness of hormonal||
0542|196|I|birth control such as pills, patch, or ring. This could cause||
0542|197|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0542|198|I|use reliable backup birth control methods while using this||
0542|199|I|medication. Also tell your doctor if you have any new spotting or||
0542|200|I|breakthrough bleeding, because these may be signs that your birth||
0542|201|I|control is not working well.||
0542|202|I|   Many drugs besides lopinavir/ritonavir may affect the heart||
0542|203|I|rhythm (QT prolongation), including pacritinib, among others.||
0542|204|B|||
0542|205|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0542|206|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0542|207|O|poison control center right away. US residents can call||
0542|208|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0542|209|O|Symptoms of overdose may include: change in amount of urine,||
0542|210|O|numbness or tingling in the arms/hands/legs/feet.||
0542|211|B|||
0542|212|N|NOTES:  Do not share this medication with others.||
0542|213|N|   Lab and/or medical tests (such as liver function, blood count,||
0542|214|N|blood cholesterol/triglyceride levels, blood sugar) should be||
0542|215|N|done while you are taking this medication. Keep all medical and||
0542|216|N|lab appointments. Consult your doctor for more details.||
0542|217|N|   Lopinavir/ritonavir is available in tablets, capsules, and||
0542|218|N|oral solution. Do not switch types of this medication without||
0542|219|N|instructions on how to do so by your doctor.||
0542|220|B|||
0542|221|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0542|222|D|remember. If it is near the time of the next dose, skip the||
0542|223|D|missed dose. Take your next dose at the regular time. Do not||
0542|224|D|double the dose to catch up.||
0542|225|B|||
0542|226|R|STORAGE:  Store in the original container at room temperature||
0542|227|R|away from light and moisture. Avoid storing this product longer||
0542|228|R|than 2 weeks outside of the container, especially in humid areas.||
0542|229|R|Do not store in the bathroom. Keep all medications away from||
0542|230|R|children and pets.||
0542|231|R|   Do not flush medications down the toilet or pour them into a||
0542|232|R|drain unless instructed to do so. Properly discard this product||
0542|233|R|when it is expired or no longer needed. Consult your pharmacist||
0542|234|R|or local waste disposal company.||
0542|235|B|||
0542|236|A|Information last revised April 2025.||
0542|237|A|Copyright(c) 2025 First Databank, Inc.||
0542|238|B|||
0543|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0543|002|Z|does NOT have all possible information about this product. This||
0543|003|Z|information does not assure that this product is safe, effective,||
0543|004|Z|or appropriate for you. This information is not individual||
0543|005|Z|medical advice and does not substitute for the advice of your||
0543|006|Z|health care professional. Always ask your health care||
0543|007|Z|professional for complete information about this product and your||
0543|008|Z|specific health needs.||
0543|009|B|||
0543|010|T|TELMISARTAN/HYDROCHLOROTHIAZIDE - ORAL||
0543|011|F|(TEL-mi-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)||
0543|012|B|||
0543|013|C|COMMON BRAND NAME(S): Micardis HCT||
0543|014|B|||
0543|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
0543|016|W|unborn baby if used during pregnancy. It is important to prevent||
0543|017|W|pregnancy while taking this medication. Consult your doctor for||
0543|018|W|more details and to discuss the use of reliable forms of birth||
0543|019|W|control while taking this medication. If you are planning||
0543|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
0543|021|W|your doctor right away.||
0543|022|B|||
0543|023|U|USES:  This medication is used to treat high blood pressure||
0543|024|U|(hypertension). Lowering high blood pressure helps prevent||
0543|025|U|strokes, heart attacks, and kidney problems. This product||
0543|026|U|contains 2 medications: telmisartan and hydrochlorothiazide.||
0543|027|U|Telmisartan belongs to a class of drugs called angiotensin||
0543|028|U|receptor blockers (ARBs). It works by relaxing blood vessels so||
0543|029|U|blood can flow more easily. Hydrochlorothiazide is a "water pill"||
0543|030|U|(diuretic). It increases the amount of urine you make, especially||
0543|031|U|when you first start the medication. It also helps to relax the||
0543|032|U|blood vessels so that blood can flow more easily.||
0543|033|U|   These medications are used together when 1 drug alone is not||
0543|034|U|controlling your blood pressure. Your doctor may direct you to||
0543|035|U|start taking the individual medications first, and then switch||
0543|036|U|you over to this combination product if this is the best dose||
0543|037|U|combination for you.||
0543|038|B|||
0543|039|V|OTHER USES:  This section contains uses of this drug that are not||
0543|040|V|listed in the approved professional labeling for the drug but||
0543|041|V|that may be prescribed by your health care professional. Use this||
0543|042|V|drug for a condition that is listed in this section only if it||
0543|043|V|has been so prescribed by your health care professional.||
0543|044|V|   This drug may also be used for heart failure.||
0543|045|B|||
0543|046|H|HOW TO USE:  Take this medication by mouth with or without food||
0543|047|H|as directed by your doctor, usually once daily. It is best to||
0543|048|H|avoid taking this medication within 4 hours of your bedtime to||
0543|049|H|avoid having to get up to urinate. Consult your doctor or||
0543|050|H|pharmacist if you have questions about your dosing schedule.||
0543|051|H|   The dosage is based on your medical condition and response to||
0543|052|H|treatment.||
0543|053|H|   Use this medication regularly to get the most benefit from it.||
0543|054|H|To help you remember, take it at the same time each day. Keep||
0543|055|H|taking this medication even if you feel well. Most people with||
0543|056|H|high blood pressure do not feel sick. It may take up to 4 weeks||
0543|057|H|before you get the full benefit of this drug.||
0543|058|H|   If you also take certain drugs to lower your cholesterol (bile||
0543|059|H|acid-binding resins such as cholestyramine or colestipol), take||
0543|060|H|this product at least 4 hours before or at least 4 to 6 hours||
0543|061|H|after these medications.||
0543|062|H|   Tell your doctor if your condition does not get better or if||
0543|063|H|it gets worse (your blood pressure readings remain high or||
0543|064|H|increase).||
0543|065|B|||
0543|066|S|SIDE EFFECTS:  Dizziness and lightheadedness may occur as your||
0543|067|S|body adjusts to the medication. Tiredness and diarrhea may also||
0543|068|S|occur. If any of these effects last or get worse, tell your||
0543|069|S|doctor or pharmacist promptly.||
0543|070|S|   To reduce the risk of dizziness and lightheadedness, get up||
0543|071|S|slowly when rising from a sitting or lying position.||
0543|072|S|   Remember that this medication has been prescribed because your||
0543|073|S|doctor has judged that the benefit to you is greater than the||
0543|074|S|risk of side effects. Many people using this medication do not||
0543|075|S|have serious side effects.||
0543|076|S|   This product may cause dehydration and electrolyte imbalance.||
0543|077|S|Tell your doctor right away if you have any symptoms of||
0543|078|S|dehydration or electrolyte imbalance, including unusual dry||
0543|079|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0543|080|S|heartbeat, or confusion.||
0543|081|S|   Tell your doctor right away if you have any serious side||
0543|082|S|effects, including: fainting, signs of kidney problems (such as||
0543|083|S|change in the amount of urine), toe/joint pain, decrease in||
0543|084|S|vision, eye pain.||
0543|085|S|   A very serious allergic reaction to this drug is rare.||
0543|086|S|However, get medical help right away if you notice any symptoms||
0543|087|S|of a serious allergic reaction, including: rash, itching/swelling||
0543|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0543|089|S|breathing.||
0543|090|S|   This is not a complete list of possible side effects. If you||
0543|091|S|notice other effects not listed above, contact your doctor or||
0543|092|S|pharmacist.||
0543|093|S|   In the US -||
0543|094|S|   Call your doctor for medical advice about side effects. You||
0543|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0543|096|S|www.fda.gov/medwatch.||
0543|097|S|   In Canada - Call your doctor for medical advice about side||
0543|098|S|effects. You may report side effects to Health Canada at||
0543|099|S|1-866-234-2345.||
0543|100|B|||
0543|101|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0543|102|P|pharmacist if you are allergic to telmisartan or||
0543|103|P|hydrochlorothiazide; or if you have any other allergies. This||
0543|104|P|product may contain inactive ingredients, which can cause||
0543|105|P|allergic reactions or other problems. Talk to your pharmacist for||
0543|106|P|more details.||
0543|107|P|   Before using this medication, tell your doctor or pharmacist||
0543|108|P|your medical history, especially of: kidney disease (such as||
0543|109|P|renal artery stenosis), liver disease, bile duct blockage,||
0543|110|P|dehydration, untreated electrolytes imbalance (such as low or||
0543|111|P|high potassium), gout, lupus, skin cancer.||
0543|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0543|113|P|can make you more dizzy. Do not drive, use machinery, or do||
0543|114|P|anything that needs alertness until you can do it safely. Limit||
0543|115|P|alcoholic beverages. Talk to your doctor if you are using||
0543|116|P|marijuana (cannabis).||
0543|117|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0543|118|P|and cause you to feel lightheaded. Tell your doctor if you have||
0543|119|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0543|120|P|of fluids unless your doctor tells you not to.||
0543|121|P|   Before having surgery, tell your doctor or dentist about all||
0543|122|P|the products you use (including prescription drugs,||
0543|123|P|nonprescription drugs, and herbal products).||
0543|124|P|   If you have diabetes, this medication may affect your blood||
0543|125|P|sugar. Check your blood sugar regularly as directed and share the||
0543|126|P|results with your doctor. Tell your doctor right away if you have||
0543|127|P|symptoms of high blood sugar such as increased thirst/urination.||
0543|128|P|Your doctor may need to adjust your diabetes medication, exercise||
0543|129|P|program, or diet.||
0543|130|P|   This product may affect your potassium levels. Before using||
0543|131|P|potassium supplements or salt substitutes that contain potassium,||
0543|132|P|consult your doctor or pharmacist.||
0543|133|P|   This medication may make you more sensitive to the sun. It may||
0543|134|P|also increase your risk for skin cancer, especially if you take||
0543|135|P|it for a long time. Limit your time in the sun. Avoid tanning||
0543|136|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0543|137|P|when outdoors. Tell your doctor right away if you get sunburned,||
0543|138|P|have skin blisters/redness, or notice new or changed moles/skin||
0543|139|P|lesions.||
0543|140|P|   Older adults may be more sensitive to the side effects of this||
0543|141|P|drug, especially dizziness and change in the amount of urine||
0543|142|P|(kidney problems).||
0543|143|P|   Tell your doctor if you are pregnant or plan to become||
0543|144|P|pregnant. You should not become pregnant while using||
0543|145|P|telmisartan/hydrochlorothiazide. Telmisartan may harm an unborn||
0543|146|P|baby. If you become pregnant, talk to your doctor right away||
0543|147|P|about the risks and benefits of this medication. (See also||
0543|148|P|Warning section.)||
0543|149|P|   This medication passes into breast milk. Consult your doctor||
0543|150|P|before breastfeeding.||
0543|151|B|||
0543|152|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
0543|153|I|   Drug interactions may change how your medications work or||
0543|154|I|increase your risk for serious side effects. This document does||
0543|155|I|not contain all possible drug interactions. Keep a list of all||
0543|156|I|the products you use (including prescription/nonprescription||
0543|157|I|drugs and herbal products) and share it with your doctor and||
0543|158|I|pharmacist. Do not start, stop, or change the dosage of any||
0543|159|I|medicines without your doctor's approval.||
0543|160|I|   Some products that may interact with this drug include:||
0543|161|I|aliskiren, dofetilide, lithium, drugs that may increase the level||
0543|162|I|of potassium in the blood (such as sparsentan, ACE inhibitors||
0543|163|I|including benazepril/lisinopril, birth control pills containing||
0543|164|I|drospirenone).||
0543|165|I|   Some products have ingredients that could raise your blood||
0543|166|I|pressure or worsen your heart failure. Tell your pharmacist what||
0543|167|I|products you are using, and ask how to use them safely||
0543|168|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0543|169|I|ibuprofen/naproxen).||
0543|170|I|   This medication may interfere with certain lab tests (such as||
0543|171|I|parathyroid test, protein-bound iodide test), possibly causing||
0543|172|I|false test results. Make sure lab personnel and all your doctors||
0543|173|I|know you use this drug.||
0543|174|B|||
0543|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0543|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0543|177|O|poison control center right away. US residents can call||
0543|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0543|179|O|Symptoms of overdose may include: fast heartbeat, severe||
0543|180|O|dizziness, fainting.||
0543|181|B|||
0543|182|N|NOTES:  Do not share this medication with others.||
0543|183|N|   Lab and/or medical tests (such kidney function, blood mineral||
0543|184|N|levels including potassium, skin exams, cholesterol levels)||
0543|185|N|should be done while you are taking this medication. Keep all||
0543|186|N|medical and lab appointments. Consult your doctor for more||
0543|187|N|details.||
0543|188|N|   Lifestyle changes that may help this medication work better||
0543|189|N|include stress reduction programs, exercise, and dietary changes.||
0543|190|N|Talk to your doctor or pharmacist about lifestyle changes that||
0543|191|N|might benefit you.||
0543|192|N|   Have your blood pressure checked regularly while taking this||
0543|193|N|medication. Learn how to monitor your own blood pressure at home,||
0543|194|N|and share the results with your doctor.||
0543|195|B|||
0543|196|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0543|197|D|remember. If it is near the time of the next dose, skip the||
0543|198|D|missed dose. Take your next dose at the regular time. Do not||
0543|199|D|double the dose to catch up.||
0543|200|B|||
0543|201|R|STORAGE:  Store at room temperature away from light and moisture.||
0543|202|R|Do not remove the medication from the blister pack until right||
0543|203|R|before using. Do not store in the bathroom. Keep all medications||
0543|204|R|away from children and pets.||
0543|205|R|   Do not flush medications down the toilet or pour them into a||
0543|206|R|drain unless instructed to do so. Properly discard this product||
0543|207|R|when it is expired or no longer needed. Consult your pharmacist||
0543|208|R|or local waste disposal company.||
0543|209|B|||
0543|210|A|Information last revised March 2025.||
0543|211|A|Copyright(c) 2025 First Databank, Inc.||
0543|212|B|||
0544|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0544|002|Z|does NOT have all possible information about this product. This||
0544|003|Z|information does not assure that this product is safe, effective,||
0544|004|Z|or appropriate for you. This information is not individual||
0544|005|Z|medical advice and does not substitute for the advice of your||
0544|006|Z|health care professional. Always ask your health care||
0544|007|Z|professional for complete information about this product and your||
0544|008|Z|specific health needs.||
0544|009|B|||
0544|010|T|EPROSARTAN - ORAL||
0544|011|F|(eh-pro-SAR-tan)||
0544|012|B|||
0544|013|C|COMMON BRAND NAME(S): Teveten||
0544|014|B|||
0544|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
0544|016|W|unborn baby if used during pregnancy. It is important to prevent||
0544|017|W|pregnancy while taking this medication. Consult your doctor for||
0544|018|W|more details and to discuss the use of reliable forms of birth||
0544|019|W|control while taking this medication. If you are planning||
0544|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
0544|021|W|your doctor right away.||
0544|022|B|||
0544|023|U|USES:  Eprosartan is used to treat high blood pressure||
0544|024|U|(hypertension). Lowering high blood pressure helps prevent||
0544|025|U|strokes, heart attacks, and kidney problems. This drug works by||
0544|026|U|relaxing blood vessels so blood can flow more easily. Eprosartan||
0544|027|U|belongs to a class of drugs called angiotensin receptor blockers||
0544|028|U|(ARBs).||
0544|029|B|||
0544|030|V|OTHER USES:  This section contains uses of this drug that are not||
0544|031|V|listed in the approved professional labeling for the drug but||
0544|032|V|that may be prescribed by your health care professional. Use this||
0544|033|V|drug for a condition that is listed in this section only if it||
0544|034|V|has been so prescribed by your health care professional.||
0544|035|V|   This drug may also be used for heart failure. It may also be||
0544|036|V|used for kidney disease and to help protect the kidneys from harm||
0544|037|V|due to diabetes.||
0544|038|B|||
0544|039|H|HOW TO USE:  Take this medication by mouth with or without food||
0544|040|H|as directed by your doctor, usually once or twice daily. Use this||
0544|041|H|medication regularly in order to get the most benefit from it. To||
0544|042|H|help you remember, use it at the same time(s) each day.||
0544|043|H|   The dosage is based on your medical condition and response to||
0544|044|H|treatment. For the treatment of high blood pressure, it may take||
0544|045|H|2 to 3 weeks before you get the full benefit of this drug.||
0544|046|H|   Keep taking this medication even if you feel well. Most people||
0544|047|H|with high blood pressure do not feel sick.||
0544|048|H|   Tell your doctor if your condition does not get better or if||
0544|049|H|it gets worse (your blood pressure readings remain high or||
0544|050|H|increase).||
0544|051|B|||
0544|052|S|SIDE EFFECTS:  Dizziness, lightheadedness, and blurred vision may||
0544|053|S|occur as your body adjusts to the medication. If any of these||
0544|054|S|effects last or get worse, tell your doctor or pharmacist||
0544|055|S|promptly.||
0544|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
0544|057|S|slowly when rising from a sitting or lying position.||
0544|058|S|   Remember that this medication has been prescribed because your||
0544|059|S|doctor has judged that the benefit to you is greater than the||
0544|060|S|risk of side effects. Many people using this medication do not||
0544|061|S|have serious side effects.||
0544|062|S|   Tell your doctor right away if you have any serious side||
0544|063|S|effects, including: fainting, decreased sexual ability, muscle||
0544|064|S|pain, symptoms of a high potassium blood level (such as muscle||
0544|065|S|weakness, slow/irregular heartbeat).||
0544|066|S|   Although eprosartan may be used to prevent kidney problems or||
0544|067|S|treat people who have kidney problems, it may also rarely cause||
0544|068|S|serious kidney problems or make them worse. Your doctor will||
0544|069|S|check your kidney function while you are taking eprosartan. Tell||
0544|070|S|your doctor right away if you have any signs of kidney problems||
0544|071|S|such as a change in the amount of urine.||
0544|072|S|   A very serious allergic reaction to this drug is rare.||
0544|073|S|However, get medical help right away if you notice any symptoms||
0544|074|S|of a serious allergic reaction, including: rash, itching/swelling||
0544|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0544|076|S|breathing.||
0544|077|S|   This is not a complete list of possible side effects. If you||
0544|078|S|notice other effects not listed above, contact your doctor or||
0544|079|S|pharmacist.||
0544|080|S|   In the US -||
0544|081|S|   Call your doctor for medical advice about side effects. You||
0544|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0544|083|S|www.fda.gov/medwatch.||
0544|084|S|   In Canada - Call your doctor for medical advice about side||
0544|085|S|effects. You may report side effects to Health Canada at||
0544|086|S|1-866-234-2345.||
0544|087|B|||
0544|088|P|PRECAUTIONS:  Before taking eprosartan, tell your doctor or||
0544|089|P|pharmacist if you are allergic to it; or to ACE inhibitors (such||
0544|090|P|as captopril, lisinopril); or if you have any other allergies.||
0544|091|P|This product may contain inactive ingredients, which can cause||
0544|092|P|allergic reactions or other problems. Talk to your pharmacist for||
0544|093|P|more details.||
0544|094|P|   Before using this medication, tell your doctor or pharmacist||
0544|095|P|your medical history, especially of: liver disease, high level of||
0544|096|P|potassium in the blood, dehydration.||
0544|097|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0544|098|P|can make you more dizzy. Do not drive, use machinery, or do||
0544|099|P|anything that needs alertness until you can do it safely. Limit||
0544|100|P|alcoholic beverages. Talk to your doctor if you are using||
0544|101|P|marijuana (cannabis).||
0544|102|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0544|103|P|and cause you to feel lightheaded. Tell your doctor if you have||
0544|104|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0544|105|P|of fluids unless your doctor tells you not to.||
0544|106|P|   This medication may increase your potassium levels. Before||
0544|107|P|using potassium supplements or salt substitutes that contain||
0544|108|P|potassium, consult your doctor or pharmacist.||
0544|109|P|   Before having surgery, tell your doctor or dentist about all||
0544|110|P|the products you use (including prescription drugs,||
0544|111|P|nonprescription drugs, and herbal products).||
0544|112|P|   Tell your doctor if you are pregnant or plan to become||
0544|113|P|pregnant. You should not become pregnant while using eprosartan.||
0544|114|P|Eprosartan may harm an unborn baby. If you become pregnant, talk||
0544|115|P|to your doctor right away about the risks and benefits of this||
0544|116|P|medication. (See also Warning section.)||
0544|117|P|   It is unknown if this drug passes into breast milk. Consult||
0544|118|P|your doctor before breastfeeding.||
0544|119|B|||
0544|120|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
0544|121|I|   Drug interactions may change how your medications work or||
0544|122|I|increase your risk for serious side effects. This document does||
0544|123|I|not contain all possible drug interactions. Keep a list of all||
0544|124|I|the products you use (including prescription/nonprescription||
0544|125|I|drugs and herbal products) and share it with your doctor and||
0544|126|I|pharmacist. Do not start, stop, or change the dosage of any||
0544|127|I|medicines without your doctor's approval.||
0544|128|I|   Some products that may interact with this drug are: aliskiren,||
0544|129|I|lithium, drugs that may increase the level of potassium in the||
0544|130|I|blood (such as sparsentan, ACE inhibitors including||
0544|131|I|benazepril/lisinopril, birth control pills containing||
0544|132|I|drospirenone).||
0544|133|I|   Some products have ingredients that could raise your blood||
0544|134|I|pressure or worsen your heart failure. Tell your pharmacist what||
0544|135|I|products you are using, and ask how to use them safely||
0544|136|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0544|137|I|ibuprofen/naproxen).||
0544|138|B|||
0544|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0544|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0544|141|O|poison control center right away. US residents can call||
0544|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0544|143|O|Symptoms of overdose may include unusually fast or slow||
0544|144|O|heartbeat, severe dizziness, fainting.||
0544|145|B|||
0544|146|N|NOTES:  Do not share this medication with others.||
0544|147|N|   Lifestyle changes such as stress reduction programs, exercise||
0544|148|N|and dietary changes may increase the effectiveness of this||
0544|149|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0544|150|N|changes that might benefit you.||
0544|151|N|   Lab and/or medical tests (such as kidney function, potassium||
0544|152|N|blood level) should be done while you are taking this medication.||
0544|153|N|Keep all medical and lab appointments. Consult your doctor for||
0544|154|N|more details.||
0544|155|N|   Have your blood pressure checked regularly while taking this||
0544|156|N|medication. Learn how to monitor your own blood pressure at home.||
0544|157|N|Discuss this with your doctor.||
0544|158|B|||
0544|159|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0544|160|D|remember. If it is near the time of the next dose, skip the||
0544|161|D|missed dose. Take your next dose at the regular time. Do not||
0544|162|D|double the dose to catch up.||
0544|163|B|||
0544|164|R|STORAGE:  Store at room temperature away from light and moisture.||
0544|165|R|Do not store in the bathroom. Keep all medications away from||
0544|166|R|children and pets.||
0544|167|R|   Do not flush medications down the toilet or pour them into a||
0544|168|R|drain unless instructed to do so. Properly discard this product||
0544|169|R|when it is expired or no longer needed. Consult your pharmacist||
0544|170|R|or local waste disposal company.||
0544|171|B|||
0544|172|A|Information last revised June 2024.||
0544|173|A|Copyright(c) 2025 First Databank, Inc.||
0544|174|B|||
0548|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0548|002|Z|does NOT have all possible information about this product. This||
0548|003|Z|information does not assure that this product is safe, effective,||
0548|004|Z|or appropriate for you. This information is not individual||
0548|005|Z|medical advice and does not substitute for the advice of your||
0548|006|Z|health care professional. Always ask your health care||
0548|007|Z|professional for complete information about this product and your||
0548|008|Z|specific health needs.||
0548|009|B|||
0548|010|T|CLOBETASOL SPRAY - TOPICAL||
0548|011|F|(kloe-BAY-ta-sol)||
0548|012|B|||
0548|013|C|COMMON BRAND NAME(S): Clobex||
0548|014|B|||
0548|015|U|USES:  Clobetasol is used by adults to treat moderate to severe||
0548|016|U|plaque psoriasis. Clobetasol reduces the swelling, itching and||
0548|017|U|redness that can occur with this condition. This medication is a||
0548|018|U|very strong (super-high-potency) corticosteroid.||
0548|019|U|   This medication is not recommended for use in children younger||
0548|020|U|than 18 years of age due to an increased risk of side effects.||
0548|021|U|Ask the doctor or pharmacist for details.||
0548|022|B|||
0548|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0548|024|H|from your pharmacist before you start using clobetasol spray and||
0548|025|H|each time you get a refill. If you have any questions, ask your||
0548|026|H|doctor or pharmacist.||
0548|027|H|   Use this medication on the skin only. Do not use it on the||
0548|028|H|face, groin or underarms unless directed to do so by your doctor.||
0548|029|H|   Wash and dry your hands before applying. Clean and dry the||
0548|030|H|affected area. Apply a thin film of the medication to the||
0548|031|H|affected area and gently rub in as directed by your doctor,||
0548|032|H|usually 2 times daily. Do not bandage, wrap or cover the area||
0548|033|H|unless directed to do so by your doctor.||
0548|034|H|   After applying the medication, wash your hands unless you are||
0548|035|H|using this medication to treat the hands. If applying this||
0548|036|H|medication near the eyes, avoid getting it in the eyes because||
0548|037|H|this may worsen or cause glaucoma. Also, avoid getting the||
0548|038|H|medication in your nose or mouth. If you get the medication in||
0548|039|H|your eyes, nose, or mouth, rinse with plenty of water.||
0548|040|H|   Use this medication exactly as prescribed. Do not increase||
0548|041|H|your dose, use it more often, or use it for longer than 2 weeks||
0548|042|H|in a row. Do not apply more than one 50-gram bottle in a given||
0548|043|H|week unless directed by your doctor. Doing so could increase your||
0548|044|H|risk of side effects.||
0548|045|H|   Tell your doctor if your condition lasts or gets worse after 2||
0548|046|H|weeks.||
0548|047|B|||
0548|048|S|SIDE EFFECTS:  Burning, stinging, itching, irritation, dryness,||
0548|049|S|and redness may occur when this medication is first applied to||
0548|050|S|the skin. These effects should disappear in a few days as your||
0548|051|S|body adjusts to the medication. If any of these effects last or||
0548|052|S|get worse, notify your doctor or pharmacist promptly.||
0548|053|S|   Remember that this medication has been prescribed because your||
0548|054|S|doctor has judged that the benefit to you is greater than the||
0548|055|S|risk of side effects. Many people using this medication do not||
0548|056|S|have serious side effects.||
0548|057|S|   Tell your doctor right away if you have any serious side||
0548|058|S|effects, including: stretch marks (striae), skin||
0548|059|S|thinning/discoloration, unusual hair growth, acne, small red||
0548|060|S|bumps on the skin (folliculitis).||
0548|061|S|   Skin infections can become worse when using this medication.||
0548|062|S|Notify your doctor if redness, swelling or irritation does not||
0548|063|S|improve.||
0548|064|S|   Rarely, it is possible this medication will be absorbed from||
0548|065|S|the skin into the bloodstream. This can lead to side effects of||
0548|066|S|too much corticosteroid. These side effects are more likely in||
0548|067|S|children, and in people who use this medication for a long time||
0548|068|S|or over large areas of the skin. Tell your doctor right away if||
0548|069|S|any of the following side effects occur: unusual/extreme||
0548|070|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0548|071|S|thirst/urination, vision problems.||
0548|072|S|   A very serious allergic reaction to this drug is rare.||
0548|073|S|However, get medical help right away if you notice any symptoms||
0548|074|S|of a serious allergic reaction, including: rash, itching/swelling||
0548|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0548|076|S|breathing.||
0548|077|S|   This is not a complete list of possible side effects. If you||
0548|078|S|notice other effects not listed above, contact your doctor or||
0548|079|S|pharmacist.||
0548|080|S|   In the US -||
0548|081|S|   Call your doctor for medical advice about side effects. You||
0548|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0548|083|S|www.fda.gov/medwatch.||
0548|084|S|   In Canada - Call your doctor for medical advice about side||
0548|085|S|effects. You may report side effects to Health Canada at||
0548|086|S|1-866-234-2345.||
0548|087|B|||
0548|088|P|PRECAUTIONS:  Before using clobetasol, tell your doctor or||
0548|089|P|pharmacist if you are allergic to it; or to any other steroids||
0548|090|P|(such as hydrocortisone, dexamethasone); or if you have any other||
0548|091|P|allergies. This product may contain inactive ingredients, which||
0548|092|P|can cause allergic reactions or other problems. Talk to your||
0548|093|P|pharmacist for more details.||
0548|094|P|   Before using this medication, tell your doctor or pharmacist||
0548|095|P|your medical history, especially of: poor blood circulation,||
0548|096|P|diabetes, other skin conditions (such as rosacea, perioral||
0548|097|P|dermatitis), immune system problems.||
0548|098|P|   Do not use if there is an infection or sore in the area to be||
0548|099|P|treated.||
0548|100|P|   Rarely, using corticosteroid medications for a long time or||
0548|101|P|over large areas of skin can make it more difficult for your body||
0548|102|P|to respond to physical stress. Before having surgery or emergency||
0548|103|P|treatment, or if you get a serious illness/injury, tell your||
0548|104|P|doctor or dentist that you are using this medication or have used||
0548|105|P|this medication within the past few months.||
0548|106|P|   Though it is unlikely, this medication may temporarily slow||
0548|107|P|down a child's growth if used for a long time. See the doctor||
0548|108|P|regularly so your child's height can be checked.||
0548|109|P|   During pregnancy, this medication should be used only when||
0548|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
0548|111|P|   It is unknown if this drug passes into breast milk when||
0548|112|P|applied to the skin. Similar medications pass into breast milk||
0548|113|P|when taken by mouth. Consult your doctor before breastfeeding.||
0548|114|B|||
0548|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0548|116|I|medications work or increase your risk for serious side effects.||
0548|117|I|This document does not contain all possible drug interactions.||
0548|118|I|Keep a list of all the products you use (including||
0548|119|I|prescription/nonprescription drugs and herbal products) and share||
0548|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
0548|121|I|the dosage of any medicines without your doctor's approval.||
0548|122|B|||
0548|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0548|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0548|125|O|poison control center right away. US residents can call||
0548|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0548|127|O|medicine may be harmful if swallowed.||
0548|128|B|||
0548|129|N|NOTES:  Do not share this medication with others.||
0548|130|N|   This medication has been prescribed for your current condition||
0548|131|N|only. Do not use it later for other skin problems unless told to||
0548|132|N|do so by your doctor. A different medication may be necessary in||
0548|133|N|those cases.||
0548|134|N|   Lab and/or medical tests (such as adrenal gland function) may||
0548|135|N|be done while you are using this medication, especially if you||
0548|136|N|use this drug for an extended period of time or apply it over||
0548|137|N|large areas of the body. Keep all medical and lab appointments.||
0548|138|N|Consult your doctor for more details.||
0548|139|B|||
0548|140|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0548|141|D|If it is near the time of the next dose, skip the missed dose.||
0548|142|D|Use your next dose at the regular time. Do not double the dose to||
0548|143|D|catch up.||
0548|144|B|||
0548|145|R|STORAGE:  Store at room temperature away from heat and open||
0548|146|R|flame. Do not puncture the bottle. Do not freeze or refrigerate.||
0548|147|R|Keep all medications away from children and pets.||
0548|148|R|   Do not flush medications down the toilet or pour them into a||
0548|149|R|drain unless instructed to do so. Properly discard this product||
0548|150|R|when it is expired or no longer needed. Consult your pharmacist||
0548|151|R|or local waste disposal company.||
0548|152|B|||
0548|153|A|Information last revised October 2024.||
0548|154|A|Copyright(c) 2025 First Databank, Inc.||
0548|155|B|||
0550|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0550|002|Z|does NOT have all possible information about this product. This||
0550|003|Z|information does not assure that this product is safe, effective,||
0550|004|Z|or appropriate for you. This information is not individual||
0550|005|Z|medical advice and does not substitute for the advice of your||
0550|006|Z|health care professional. Always ask your health care||
0550|007|Z|professional for complete information about this product and your||
0550|008|Z|specific health needs.||
0550|009|B|||
0550|010|T|MECLIZINE - ORAL||
0550|011|F|(MEK-li-zeen)||
0550|012|B|||
0550|013|C|COMMON BRAND NAME(S): Antivert, Vertin||
0550|014|B|||
0550|015|U|USES:  Meclizine is an antihistamine that is used to prevent and||
0550|016|U|treat nausea, vomiting, and dizziness caused by motion sickness.||
0550|017|U|It may also be used to reduce dizziness and loss of balance||
0550|018|U|(vertigo) caused by inner ear problems.||
0550|019|B|||
0550|020|H|HOW TO USE:  Follow all directions on the product package. If||
0550|021|H|your doctor has prescribed this medication, take it as directed.||
0550|022|H|If you have any questions, ask your doctor or pharmacist.||
0550|023|H|   Take this medication by mouth with or without food. If you are||
0550|024|H|taking the chewable tablets, chew the tablet thoroughly before||
0550|025|H|swallowing.||
0550|026|H|   The dosage is based on your medical condition and response to||
0550|027|H|treatment. Do not increase your dose or take this medication more||
0550|028|H|often than directed.||
0550|029|H|   To prevent motion sickness, take the first dose one hour||
0550|030|H|before starting activity such as travel.||
0550|031|H|   Tell your doctor if your condition does not get better or if||
0550|032|H|it gets worse.||
0550|033|B|||
0550|034|S|SIDE EFFECTS:  Drowsiness, dry mouth, and tiredness may occur. If||
0550|035|S|any of these effects last or get worse, tell your doctor or||
0550|036|S|pharmacist promptly.||
0550|037|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0550|038|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0550|039|S|substitute.||
0550|040|S|   If your doctor has directed you to use this medication,||
0550|041|S|remember that your doctor has judged that the benefit to you is||
0550|042|S|greater than the risk of side effects. Many people using this||
0550|043|S|medication do not have serious side effects.||
0550|044|S|   Tell your doctor right away if you have any serious side||
0550|045|S|effects, including: mental/mood changes (such as restlessness,||
0550|046|S|confusion), fast/irregular heartbeat, shaking (tremor),||
0550|047|S|difficulty urinating.||
0550|048|S|   Get medical help right away if you have any very serious side||
0550|049|S|effects, including: seizures.||
0550|050|S|   A very serious allergic reaction to this drug is rare.||
0550|051|S|However, get medical help right away if you notice any symptoms||
0550|052|S|of a serious allergic reaction, including: rash, itching/swelling||
0550|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0550|054|S|breathing.||
0550|055|S|   This is not a complete list of possible side effects. If you||
0550|056|S|notice other effects not listed above, contact your doctor or||
0550|057|S|pharmacist.||
0550|058|S|   In the US -||
0550|059|S|   Call your doctor for medical advice about side effects. You||
0550|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0550|061|S|www.fda.gov/medwatch.||
0550|062|S|   In Canada - Call your doctor for medical advice about side||
0550|063|S|effects. You may report side effects to Health Canada at||
0550|064|S|1-866-234-2345.||
0550|065|B|||
0550|066|P|PRECAUTIONS:  Before taking meclizine, tell your doctor or||
0550|067|P|pharmacist if you are allergic to it; or if you have any other||
0550|068|P|allergies. This product may contain inactive ingredients, which||
0550|069|P|can cause allergic reactions or other problems. Talk to your||
0550|070|P|pharmacist for more details.||
0550|071|P|   Before using this medication, tell your doctor or pharmacist||
0550|072|P|your medical history, especially of: breathing problems (such as||
0550|073|P|asthma, emphysema), high pressure in the eye (glaucoma), heart||
0550|074|P|problems, high blood pressure, seizures, stomach/intestine||
0550|075|P|problems (such as ulcers, blockage), overactive thyroid||
0550|076|P|(hyperthyroidism), difficulty urinating (for example, due to||
0550|077|P|enlarged prostate), liver problems, kidney problems.||
0550|078|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
0550|079|P|can make you more drowsy. Do not drive, use machinery, or do||
0550|080|P|anything that needs alertness until you can do it safely. Avoid||
0550|081|P|alcoholic beverages. Talk to your doctor if you are using||
0550|082|P|marijuana (cannabis).||
0550|083|P|   Before having surgery, tell your doctor or dentist about all||
0550|084|P|the products you use (including prescription drugs,||
0550|085|P|nonprescription drugs, and herbal products).||
0550|086|P|   Children may be more sensitive to the side effects of this||
0550|087|P|drug. This drug can often cause excitement in young children||
0550|088|P|instead of drowsiness.||
0550|089|P|   Older adults may be more sensitive to the side effects of this||
0550|090|P|drug, especially drowsiness, confusion, or trouble urinating.||
0550|091|P|Drowsiness and confusion can increase the risk of falling.||
0550|092|P|   During pregnancy, this medication should be used only when||
0550|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
0550|094|P|   It is unknown if this drug passes into breast milk. Consult||
0550|095|P|your doctor before breastfeeding.||
0550|096|B|||
0550|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0550|098|I|medications work or increase your risk for serious side effects.||
0550|099|I|This document does not contain all possible drug interactions.||
0550|100|I|Keep a list of all the products you use (including||
0550|101|I|prescription/nonprescription drugs and herbal products) and share||
0550|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
0550|103|I|the dosage of any medicines without your doctor's approval.||
0550|104|I|   Some products that may interact with this drug include:||
0550|105|I|antihistamines applied to the skin (such as diphenhydramine||
0550|106|I|cream, ointment, spray).||
0550|107|I|   Tell your doctor or pharmacist if you are taking other||
0550|108|I|products that cause drowsiness such as opioid pain or cough||
0550|109|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0550|110|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0550|111|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0550|112|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0550|113|I|diphenhydramine).||
0550|114|I|   Check the labels on all your medicines (such as allergy or||
0550|115|I|cough-and-cold products) because they may contain ingredients||
0550|116|I|that cause drowsiness. Ask your pharmacist about using those||
0550|117|I|products safely.||
0550|118|I|   This medication may interfere with certain lab tests (such as||
0550|119|I|allergy skin test), possibly causing false test results. Make||
0550|120|I|sure lab personnel and all your doctors know you use this drug.||
0550|121|B|||
0550|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0550|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0550|124|O|poison control center right away. US residents can call||
0550|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0550|126|O|Symptoms of overdose may include: severe drowsiness, seizures,||
0550|127|O|widened pupils. In children, mental/mood changes (such as||
0550|128|O|restlessness, irritability, hallucinations) may occur before||
0550|129|O|drowsiness.||
0550|130|B|||
0550|131|N|NOTES:  Keep all medical and lab appointments.||
0550|132|B|||
0550|133|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0550|134|D|remember. If it is near the time of the next dose, skip the||
0550|135|D|missed dose. Take your next dose at the regular time. Do not||
0550|136|D|double the dose to catch up.||
0550|137|B|||
0550|138|R|STORAGE:  Store at room temperature away from light and moisture.||
0550|139|R|Do not store in the bathroom. Keep all medications away from||
0550|140|R|children and pets.||
0550|141|R|   Do not flush medications down the toilet or pour them into a||
0550|142|R|drain unless instructed to do so. Properly discard this product||
0550|143|R|when it is expired or no longer needed. Consult your pharmacist||
0550|144|R|or local waste disposal company.||
0550|145|B|||
0550|146|A|Information last revised October 2024.||
0550|147|A|Copyright(c) 2025 First Databank, Inc.||
0550|148|B|||
0553|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0553|002|Z|does NOT have all possible information about this product. This||
0553|003|Z|information does not assure that this product is safe, effective,||
0553|004|Z|or appropriate for you. This information is not individual||
0553|005|Z|medical advice and does not substitute for the advice of your||
0553|006|Z|health care professional. Always ask your health care||
0553|007|Z|professional for complete information about this product and your||
0553|008|Z|specific health needs.||
0553|009|B|||
0553|010|T|CODEINE - ORAL||
0553|011|F|(KOE-deen)||
0553|012|B|||
0553|013|W|WARNING:  Codeine has a risk for abuse and addiction, which can||
0553|014|W|lead to overdose and death. Codeine may also cause severe,||
0553|015|W|possibly fatal, breathing problems. To lower your risk, your||
0553|016|W|doctor should have you take the smallest dose of codeine that||
0553|017|W|works, and take it for the shortest possible time. See also How||
0553|018|W|to Use section for more information about addiction.||
0553|019|W|   Ask your doctor or pharmacist if you should have medication||
0553|020|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0553|021|W|Teach your family or household members about the signs of an||
0553|022|W|opioid overdose and how to treat it.||
0553|023|W|   The risk for severe breathing problems is higher when you||
0553|024|W|start this medication and after a dose increase, or if you take||
0553|025|W|the wrong dose/strength. Taking this medication with alcohol or||
0553|026|W|other drugs that can cause drowsiness or breathing problems may||
0553|027|W|cause very serious side effects, including death. Also, other||
0553|028|W|medications can affect the removal of codeine from your body,||
0553|029|W|which may affect how codeine works. Be sure you know how to take||
0553|030|W|codeine and what other drugs you should avoid taking with it. See||
0553|031|W|also Drug Interactions section. Get medical help right away if||
0553|032|W|any of these very serious side effects occur: slow/shallow||
0553|033|W|breathing, unusual lightheadedness, severe drowsiness/dizziness,||
0553|034|W|difficulty waking up.||
0553|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0553|036|W|or abuse. If someone accidentally swallows this drug, get medical||
0553|037|W|help right away.||
0553|038|W|   Before using this medication, women of childbearing age should||
0553|039|W|talk with their doctor(s) about the risks and benefits. Tell your||
0553|040|W|doctor if you are pregnant or if you plan to become pregnant.||
0553|041|W|During pregnancy, this medication should be used only when||
0553|042|W|clearly needed. It may slightly increase the risk of birth||
0553|043|W|defects if used during the first two months of pregnancy. Also,||
0553|044|W|using it for a long time or in high doses near the expected||
0553|045|W|delivery date may harm the unborn baby. To lessen the risk, take||
0553|046|W|the smallest effective dose for the shortest possible time.||
0553|047|W|Babies born to mothers who use this drug for a long time may||
0553|048|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0553|049|W|doctor right away if you notice any symptoms in your newborn baby||
0553|050|W|such as crying that doesn't stop, slow/shallow breathing,||
0553|051|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0553|052|W|difficulty gaining weight.||
0553|053|W|   Children younger than 18 years should not use products that||
0553|054|W|contain codeine. Some children are more sensitive to codeine and||
0553|055|W|have had very serious (rarely fatal) breathing problems such as||
0553|056|W|slow/shallow breathing (see also Side Effects section). The risk||
0553|057|W|is greater in children who are obese or have breathing problems,||
0553|058|W|or after certain surgeries (including tonsil/adenoid removal).||
0553|059|W|Talk with your doctor or pharmacist about the risks and benefits||
0553|060|W|of this medication.||
0553|061|B|||
0553|062|U|USES:  See also Warning section.||
0553|063|U|   This medication is used to help relieve mild to moderate pain.||
0553|064|U|Codeine belongs to a class of drugs known as opioid analgesics.||
0553|065|U|It works in the brain to change how your body feels and responds||
0553|066|U|to pain.||
0553|067|B|||
0553|068|V|OTHER USES:  This section contains uses of this drug that are not||
0553|069|V|listed in the approved professional labeling for the drug but||
0553|070|V|that may be prescribed by your health care professional. Use this||
0553|071|V|drug for a condition that is listed in this section only if it||
0553|072|V|has been so prescribed by your health care professional.||
0553|073|V|   This drug may also be used to control a cough in adults.||
0553|074|B|||
0553|075|H|HOW TO USE:  Read the Medication Guide provided by your||
0553|076|H|pharmacist before you start taking codeine and each time you get||
0553|077|H|a refill. If you have any questions, ask your doctor or||
0553|078|H|pharmacist.||
0553|079|H|   Take this medication by mouth as directed by your doctor. You||
0553|080|H|may take this drug with or without food. If you have nausea, it||
0553|081|H|may help to take this drug with food. Ask your doctor or||
0553|082|H|pharmacist about other ways to decrease nausea (such as lying||
0553|083|H|down for 1 to 2 hours with as little head movement as possible).||
0553|084|H|   If you are using the liquid form of this medication, carefully||
0553|085|H|measure the dose using a special measuring device/spoon. Do not||
0553|086|H|use a household spoon because you may not get the correct dose.||
0553|087|H|   The dosage is based on your medical condition and response to||
0553|088|H|treatment. Do not increase your dose or use this drug more often||
0553|089|H|or for longer than prescribed, because your risk of side effects||
0553|090|H|may increase. Properly stop the medication when so directed.||
0553|091|H|   Pain medications work best if they are used as the first signs||
0553|092|H|of pain occur. If you wait until the pain has worsened, the||
0553|093|H|medication may not work as well.||
0553|094|H|   If you have ongoing pain (such as due to cancer), your doctor||
0553|095|H|may direct you to also take long-acting opioid medications. In||
0553|096|H|that case, this medication might be used for sudden||
0553|097|H|(breakthrough) pain only as needed. Other pain relievers (such as||
0553|098|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
0553|099|H|or pharmacist about using codeine safely with other drugs.||
0553|100|H|   Suddenly stopping this medication may cause withdrawal,||
0553|101|H|especially if you have used it for a long time or in high doses.||
0553|102|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0553|103|H|Tell your doctor or pharmacist right away if you have any||
0553|104|H|withdrawal symptoms such as restlessness, mental/mood changes||
0553|105|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0553|106|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0553|107|H|aches, or sudden changes in behavior.||
0553|108|H|   When this medication is used for a long time, it may not work||
0553|109|H|as well. Talk with your doctor if this medication stops working||
0553|110|H|well.||
0553|111|H|   Though it helps many people, this medication may sometimes||
0553|112|H|cause addiction. This risk may be higher if you have a||
0553|113|H|mental/mood disorder or a substance use disorder (such as overuse||
0553|114|H|of or addiction to drugs/alcohol). Take this medication exactly||
0553|115|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0553|116|H|pharmacist for more details.||
0553|117|H|   Tell your doctor if your pain does not get better or if it||
0553|118|H|gets worse, or if you have any new pain.||
0553|119|H|   If you are taking codeine to control a cough, tell your doctor||
0553|120|H|if your cough does not get better in 5 days or if your condition||
0553|121|H|gets worse.||
0553|122|B|||
0553|123|S|SIDE EFFECTS:  See also Warning section.||
0553|124|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0553|125|S|drowsiness, or sweating may occur. If any of these effects last||
0553|126|S|or get worse, tell your doctor or pharmacist promptly.||
0553|127|S|   To prevent constipation, eat dietary fiber, drink enough||
0553|128|S|water, and exercise. You may also need to take a laxative. Ask||
0553|129|S|your pharmacist which type of laxative is right for you.||
0553|130|S|   To reduce the risk of dizziness and lightheadedness, get up||
0553|131|S|slowly when rising from a sitting or lying position.||
0553|132|S|   Remember that this medication has been prescribed because your||
0553|133|S|doctor has judged that the benefit to you is greater than the||
0553|134|S|risk of side effects. Many people using this medication do not||
0553|135|S|have serious side effects.||
0553|136|S|   Tell your doctor right away if you have any serious side||
0553|137|S|effects, including: interrupted breathing during sleep (sleep||
0553|138|S|apnea), mental/mood changes (such as agitation, depression,||
0553|139|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
0553|140|S|fast/slow heartbeat, vision changes, signs of your adrenal glands||
0553|141|S|not working well (such as loss of appetite, unusual tiredness,||
0553|142|S|weight loss), trouble swallowing.||
0553|143|S|   Get medical help right away if you have any very serious side||
0553|144|S|effects, including: fainting, seizure.||
0553|145|S|   Codeine is changed into a strong opioid drug (morphine) in||
0553|146|S|your body. In some people, this change happens faster and more||
0553|147|S|completely than usual, which increases the risk of very serious||
0553|148|S|side effects. Get medical help right away if you notice any of||
0553|149|S|the following: slow/shallow breathing, severe||
0553|150|S|drowsiness/difficulty waking up, confusion.||
0553|151|S|   A very serious allergic reaction to this drug is rare.||
0553|152|S|However, get medical help right away if you notice any symptoms||
0553|153|S|of a serious allergic reaction, including: rash, itching/swelling||
0553|154|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0553|155|S|breathing.||
0553|156|S|   This is not a complete list of possible side effects. If you||
0553|157|S|notice other effects not listed above, contact your doctor or||
0553|158|S|pharmacist.||
0553|159|S|   In the US -||
0553|160|S|   Call your doctor for medical advice about side effects. You||
0553|161|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0553|162|S|www.fda.gov/medwatch.||
0553|163|S|   In Canada - Call your doctor for medical advice about side||
0553|164|S|effects. You may report side effects to Health Canada at||
0553|165|S|1-866-234-2345.||
0553|166|B|||
0553|167|P|PRECAUTIONS:  Before taking codeine, tell your doctor or||
0553|168|P|pharmacist if you are allergic to it; or to other opioid pain||
0553|169|P|medications (such as morphine); or if you have any other||
0553|170|P|allergies. This product may contain inactive ingredients (such as||
0553|171|P|sulfites found in some brands), which can cause allergic||
0553|172|P|reactions or other problems. Talk to your pharmacist for more||
0553|173|P|details.||
0553|174|P|   Before using this medication, tell your doctor or pharmacist||
0553|175|P|your medical history, especially of: brain disorders (such as||
0553|176|P|head injury, tumor, seizures), breathing problems (such as||
0553|177|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0553|178|P|gallbladder disease, kidney disease, liver disease, mental/mood||
0553|179|P|disorders (such as confusion, depression, thoughts of suicide),||
0553|180|P|personal or family history of a substance use disorder (such as||
0553|181|P|overuse of or addiction to drugs/alcohol), obesity,||
0553|182|P|stomach/intestinal problems (such as blockage, constipation,||
0553|183|P|diarrhea due to infection, paralytic ileus), disease of the||
0553|184|P|pancreas (pancreatitis), difficulty urinating (such as due to||
0553|185|P|enlarged prostate).||
0553|186|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0553|187|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0553|188|P|machinery, or do anything that needs alertness until you can do||
0553|189|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0553|190|P|are using marijuana (cannabis).||
0553|191|P|   Before having surgery, tell your doctor or dentist about all||
0553|192|P|the products you use (including prescription drugs,||
0553|193|P|nonprescription drugs, and herbal products).||
0553|194|P|   Older adults may be more sensitive to the side effects of this||
0553|195|P|drug, especially confusion, dizziness, drowsiness, and||
0553|196|P|slow/shallow breathing.||
0553|197|P|   During pregnancy, this medication should be used only when||
0553|198|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0553|199|P|benefits with your doctor. (See also Warning section.)||
0553|200|P|   This medication passes into breast milk and may have||
0553|201|P|undesirable effects on a nursing infant, such as unusual||
0553|202|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
0553|203|P|limpness. Consult your doctor before breastfeeding.||
0553|204|B|||
0553|205|I|DRUG INTERACTIONS:  See also Warning section.||
0553|206|I|   Drug interactions may change how your medications work or||
0553|207|I|increase your risk for serious side effects. This document does||
0553|208|I|not contain all possible drug interactions. Keep a list of all||
0553|209|I|the products you use (including prescription/nonprescription||
0553|210|I|drugs and herbal products) and share it with your doctor and||
0553|211|I|pharmacist. Do not start, stop, or change the dosage of any||
0553|212|I|medicines without your doctor's approval.||
0553|213|I|   Some products that may interact with this drug include:||
0553|214|I|certain pain medications (mixed opioid agonist-antagonists such||
0553|215|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0553|216|I|samidorphan.||
0553|217|I|   The risk of serious side effects (such as slow/shallow||
0553|218|I|breathing, severe drowsiness/dizziness) may be increased if this||
0553|219|I|medication is taken with other products that may also cause||
0553|220|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0553|221|I|if you are taking other products such as other opioid pain or||
0553|222|I|cough relievers (such as morphine, hydrocodone), alcohol,||
0553|223|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0553|224|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0553|225|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0553|226|I|cetirizine, diphenhydramine).||
0553|227|I|   Check the labels on all your medicines (such as allergy or||
0553|228|I|cough-and-cold products) because they may contain ingredients||
0553|229|I|that cause drowsiness. Ask your pharmacist about using those||
0553|230|I|products safely.||
0553|231|I|   Other medications can affect the removal of codeine from your||
0553|232|I|body, which may affect how codeine works. Examples include azole||
0553|233|I|antifungals (such as ketoconazole), bupropion, fluoxetine,||
0553|234|I|macrolide antibiotics (such as erythromycin), paroxetine,||
0553|235|I|quinidine, rifamycins (such as rifabutin, rifampin), ritonavir,||
0553|236|I|certain drugs used to treat seizures (such as carbamazepine,||
0553|237|I|phenytoin), among others.||
0553|238|I|   This medication may interfere with certain lab tests (such as||
0553|239|I|amylase/lipase levels), possibly causing false test results. Make||
0553|240|I|sure lab personnel and all your doctors know you use this drug.||
0553|241|B|||
0553|242|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0553|243|O|as passing out or trouble breathing, give them naloxone or||
0553|244|O|nalmefene if available, then call 911. If the person is awake and||
0553|245|O|has no symptoms, call a poison control center right away. US||
0553|246|O|residents can call 1-800-222-1222. Canada residents can call||
0553|247|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0553|248|O|breathing, slow heartbeat, severe drowsiness, coma.||
0553|249|B|||
0553|250|N|NOTES:  Do not share this medication with others. Sharing it is||
0553|251|N|against the law.||
0553|252|N|   This medication has been prescribed for your current condition||
0553|253|N|only. Do not use it later for another condition unless your||
0553|254|N|doctor directs you to do so. A different medication may be||
0553|255|N|necessary in that case.||
0553|256|B|||
0553|257|D|MISSED DOSE:  If you are taking this medication on a regular||
0553|258|D|schedule and you miss a dose, take it as soon as you remember. If||
0553|259|D|it is near the time of the next dose, skip the missed dose. Take||
0553|260|D|your next dose at the regular time. Do not double the dose to||
0553|261|D|catch up.||
0553|262|B|||
0553|263|R|STORAGE:  Store at room temperature away from light and moisture.||
0553|264|R|Do not store in the bathroom. Keep all medications away from||
0553|265|R|children and pets.||
0553|266|R|   Do not flush medications down the toilet or pour them into a||
0553|267|R|drain unless instructed to do so. Properly discard this product||
0553|268|R|when it is expired or no longer needed. Consult your pharmacist||
0553|269|R|or local waste disposal company.||
0553|270|B|||
0553|271|A|Information last revised August 2025.||
0553|272|A|Copyright(c) 2025 First Databank, Inc.||
0553|273|B|||
0554|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0554|002|Z|does NOT have all possible information about this product. This||
0554|003|Z|information does not assure that this product is safe, effective,||
0554|004|Z|or appropriate for you. This information is not individual||
0554|005|Z|medical advice and does not substitute for the advice of your||
0554|006|Z|health care professional. Always ask your health care||
0554|007|Z|professional for complete information about this product and your||
0554|008|Z|specific health needs.||
0554|009|B|||
0554|010|T|TEPOTINIB - ORAL||
0554|011|F|(tep-OH-ti-nib)||
0554|012|B|||
0554|013|C|COMMON BRAND NAME(S): Tepmetko||
0554|014|B|||
0554|015|U|USES:  This medication is used to treat a certain type of lung||
0554|016|U|cancer (non-small cell lung cancer). Tepotinib belongs to a class||
0554|017|U|of drugs known as kinase inhibitors. It works by slowing or||
0554|018|U|stopping the growth of cancer cells.||
0554|019|B|||
0554|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0554|021|H|from your pharmacist before you start taking tepotinib and each||
0554|022|H|time you get a refill. If you have any questions, ask your doctor||
0554|023|H|or pharmacist.||
0554|024|H|   Take this medication by mouth with food as directed by your||
0554|025|H|doctor, usually once daily. Swallow the tablets whole. Do not||
0554|026|H|chew, crush, or split the tablets.||
0554|027|H|   If you have trouble swallowing the tablets whole, place the||
0554|028|H|tablets in a cup with 30 milliliters (1 ounce) of non-carbonated||
0554|029|H|water. Stir well until the tablets break into small pieces. Do||
0554|030|H|not crush the tablets. The tablets will not completely dissolve.||
0554|031|H|Drink all of the mixture without chewing, right away or within 1||
0554|032|H|hour. Add more water (30 milliliters/1 ounce) to the cup and||
0554|033|H|drink all of the mixture to make sure you are getting all of the||
0554|034|H|drug. Use only non-carbonated water for mixing. Do not prepare a||
0554|035|H|supply ahead of time.||
0554|036|H|   If you are giving this mixture through a tube into the stomach||
0554|037|H|(such as a nasogastric tube), ask your health care professional||
0554|038|H|for detailed instructions on how to give it.||
0554|039|H|   If you vomit after taking a dose, do not take another dose.||
0554|040|H|Take your next dose at your regular scheduled time.||
0554|041|H|   Use this medication regularly to get the most benefit from it.||
0554|042|H|To help you remember, take it at the same time each day.||
0554|043|H|   The dosage is based on your medical condition and response to||
0554|044|H|treatment. Do not increase your dose or use this drug more often||
0554|045|H|or for longer than prescribed. Your condition will not improve||
0554|046|H|any faster, and your risk of side effects will increase.||
0554|047|H|   Since this drug can be absorbed through the skin and lungs and||
0554|048|H|may harm an unborn baby, women who are pregnant or who may become||
0554|049|H|pregnant should not handle this medication or breathe the dust||
0554|050|H|from the tablets.||
0554|051|B|||
0554|052|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea or constipation,||
0554|053|S|swelling, tiredness, abdominal pain, muscle/joint pain, and loss||
0554|054|S|of appetite may occur. If any of these effects last or get worse,||
0554|055|S|tell your doctor or pharmacist promptly.||
0554|056|S|   People using this medication may have serious side effects.||
0554|057|S|However, you have been prescribed this drug because your doctor||
0554|058|S|has judged that the benefit to you is greater than the risk of||
0554|059|S|side effects. Careful monitoring by your doctor may decrease your||
0554|060|S|risk.||
0554|061|S|   This medication may lower your ability to fight infections.||
0554|062|S|This may make you more likely to get a serious (rarely fatal)||
0554|063|S|infection or make any infection you have worse. Tell your doctor||
0554|064|S|right away if you have any signs of infection (such as sore||
0554|065|S|throat that doesn't go away, fever, chills).||
0554|066|S|   Tepotinib can cause severe (possibly fatal) lung problems||
0554|067|S|(interstitial lung disease/pneumonitis). Tell your doctor right||
0554|068|S|away if you have any symptoms of lung problems (such as cough,||
0554|069|S|shortness of breath, trouble breathing, fever).||
0554|070|S|   Tepotinib may cause serious (possibly fatal) liver disease.||
0554|071|S|Your doctor will test your liver function while you are taking||
0554|072|S|this medication. Tell your doctor right away if you have any||
0554|073|S|symptoms of liver damage, such as nausea/vomiting that doesn't||
0554|074|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
0554|075|S|eyes/skin, dark urine.||
0554|076|S|   A very serious allergic reaction to this drug is rare.||
0554|077|S|However, get medical help right away if you notice any symptoms||
0554|078|S|of a serious allergic reaction, including: rash, itching/swelling||
0554|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0554|080|S|breathing.||
0554|081|S|   This is not a complete list of possible side effects. If you||
0554|082|S|notice other effects not listed above, contact your doctor or||
0554|083|S|pharmacist.||
0554|084|S|   In the US -||
0554|085|S|   Call your doctor for medical advice about side effects. You||
0554|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0554|087|S|www.fda.gov/medwatch.||
0554|088|S|   In Canada - Call your doctor for medical advice about side||
0554|089|S|effects. You may report side effects to Health Canada at||
0554|090|S|1-866-234-2345.||
0554|091|B|||
0554|092|P|PRECAUTIONS:  Before taking tepotinib, tell your doctor or||
0554|093|P|pharmacist if you are allergic to it; or if you have any other||
0554|094|P|allergies. This product may contain inactive ingredients, which||
0554|095|P|can cause allergic reactions or other problems. Talk to your||
0554|096|P|pharmacist for more details.||
0554|097|P|   Before using this medication, tell your doctor or pharmacist||
0554|098|P|your medical history, especially of: liver problems, lung or||
0554|099|P|breathing problems other than your lung cancer, recent/current||
0554|100|P|infection.||
0554|101|P|   Tepotinib can make you more likely to get infections or may||
0554|102|P|make current infections worse. Stay away from anyone who has an||
0554|103|P|infection that may easily spread (such as chickenpox, COVID-19,||
0554|104|P|measles, flu). Talk to your doctor if you have been exposed to an||
0554|105|P|infection or for more details.||
0554|106|P|   Tell your health care professional that you are using||
0554|107|P|tepotinib before having any immunizations/vaccinations. Avoid||
0554|108|P|contact with people who have recently received live vaccines||
0554|109|P|(such as flu vaccine inhaled through the nose).||
0554|110|P|   Before having surgery, tell your doctor or dentist about all||
0554|111|P|the products you use (including prescription drugs,||
0554|112|P|nonprescription drugs, and herbal products).||
0554|113|P|   Since this drug can be absorbed through the skin and lungs and||
0554|114|P|may harm an unborn baby, women who are pregnant or who may become||
0554|115|P|pregnant should not handle this medication or breathe the dust||
0554|116|P|from the tablets.||
0554|117|P|   Tell your doctor if you are pregnant or plan to become||
0554|118|P|pregnant. You should not become pregnant while taking tepotinib.||
0554|119|P|Tepotinib may harm an unborn baby. Your doctor should order a||
0554|120|P|pregnancy test before you start this medication. Men and women||
0554|121|P|using this medication should ask about reliable forms of birth||
0554|122|P|control during treatment and for 1 week after the last dose. If||
0554|123|P|you or your partner becomes pregnant, talk to your doctor right||
0554|124|P|away about the risks and benefits of this medication.||
0554|125|P|   It is unknown if this drug passes into breast milk. Because of||
0554|126|P|the possible risk to the infant, breastfeeding is not recommended||
0554|127|P|while using this drug and for 1 week after the last dose. Consult||
0554|128|P|your doctor before breastfeeding.||
0554|129|B|||
0554|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0554|131|I|medications work or increase your risk for serious side effects.||
0554|132|I|This document does not contain all possible drug interactions.||
0554|133|I|Keep a list of all the products you use (including||
0554|134|I|prescription/nonprescription drugs and herbal products) and share||
0554|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
0554|136|I|the dosage of any medicines without your doctor's approval.||
0554|137|B|||
0554|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0554|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0554|140|O|poison control center right away. US residents can call||
0554|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0554|142|B|||
0554|143|N|NOTES:  Do not share this medication with others.||
0554|144|N|   Lab and/or medical tests (such as liver function, complete||
0554|145|N|blood count, amylase/lipase level) should be done while you are||
0554|146|N|taking this medication. Keep all medical and lab appointments.||
0554|147|N|Consult your doctor for more details.||
0554|148|B|||
0554|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0554|150|D|remember. If it is within 8 hours of the next dose, skip the||
0554|151|D|missed dose. Take your next dose at the regular time. Do not||
0554|152|D|double the dose to catch up.||
0554|153|B|||
0554|154|R|STORAGE:  Store in the original package at room temperature away||
0554|155|R|from light and moisture. Do not store in the bathroom. Keep all||
0554|156|R|medications away from children and pets.||
0554|157|R|   Do not flush medications down the toilet or pour them into a||
0554|158|R|drain unless instructed to do so. Properly discard this product||
0554|159|R|when it is expired or no longer needed. Consult your pharmacist||
0554|160|R|or local waste disposal company.||
0554|161|B|||
0554|162|M|MEDICAL ALERT:  Your condition can cause complications in a||
0554|163|M|medical emergency. For information about enrolling in MedicAlert,||
0554|164|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0554|165|B|||
0554|166|A|Information last revised April 2025.||
0554|167|A|Copyright(c) 2025 First Databank, Inc.||
0554|168|B|||
0557|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0557|002|Z|does NOT have all possible information about this product. This||
0557|003|Z|information does not assure that this product is safe, effective,||
0557|004|Z|or appropriate for you. This information is not individual||
0557|005|Z|medical advice and does not substitute for the advice of your||
0557|006|Z|health care professional. Always ask your health care||
0557|007|Z|professional for complete information about this product and your||
0557|008|Z|specific health needs.||
0557|009|B|||
0557|010|T|NYSTATIN CREAM - VAGINAL||
0557|011|F|(NYE-stat-in)||
0557|012|B|||
0557|013|U|USES:  This medication is used to treat vaginal fungal||
0557|014|U|infections, commonly called vaginal yeast infections. It helps to||
0557|015|U|reduce itchiness, redness, and irritating discharge. Nystatin||
0557|016|U|works by stopping the growth of the fungus.||
0557|017|B|||
0557|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0557|019|H|from your pharmacist before you start using this medication. If||
0557|020|H|you have any questions, ask your doctor or pharmacist.||
0557|021|H|   This product is for vaginal use. With clean hands, fill the||
0557|022|H|applicator with this cream to the level indicated. Insert the||
0557|023|H|applicator high into the vagina, then push the plunger to release||
0557|024|H|the medication. Use this medication usually once a day at||
0557|025|H|bedtime, or twice a day in the morning and evening, as directed||
0557|026|H|by your doctor. If the applicator is reusable, follow the product||
0557|027|H|instructions on how to clean it.||
0557|028|H|   To prevent medication from leaking out of the vagina, lie down||
0557|029|H|as soon as possible after use. You may use a sanitary napkin to||
0557|030|H|prevent clothing stains. Do not use tampons while using this||
0557|031|H|medication because they can decrease its effectiveness. In most||
0557|032|H|cases, you should not use medicated douches during nystatin||
0557|033|H|treatment. Ask your doctor or pharmacist if you have any||
0557|034|H|questions.||
0557|035|H|   Use this medication regularly in order to get the most benefit||
0557|036|H|from it. Remember to use this medication at the same time(s) each||
0557|037|H|day.||
0557|038|H|   Continue to use this medication for the full time prescribed,||
0557|039|H|even if symptoms disappear after a few days and even if you get||
0557|040|H|your menstrual period. Stopping the medication too early may||
0557|041|H|result in a return of the infection.||
0557|042|H|   Tell your doctor if your condition lasts or gets worse.||
0557|043|B|||
0557|044|S|SIDE EFFECTS:  Though very unlikely, nystatin may cause vaginal||
0557|045|S|irritation. If this effect lasts or gets worse, notify your||
0557|046|S|doctor or pharmacist promptly.||
0557|047|S|   Remember that this medication has been prescribed because your||
0557|048|S|doctor has judged that the benefit to you is greater than the||
0557|049|S|risk of side effects. Many people using this medication do not||
0557|050|S|have serious side effects.||
0557|051|S|   A very serious allergic reaction to this drug is rare.||
0557|052|S|However, get medical help right away if you notice any symptoms||
0557|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0557|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0557|055|S|breathing.||
0557|056|S|   This is not a complete list of possible side effects. If you||
0557|057|S|notice other effects not listed above, contact your doctor or||
0557|058|S|pharmacist.||
0557|059|S|   In the US -||
0557|060|S|   Call your doctor for medical advice about side effects. You||
0557|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0557|062|S|www.fda.gov/medwatch.||
0557|063|S|   In Canada - Call your doctor for medical advice about side||
0557|064|S|effects. You may report side effects to Health Canada at||
0557|065|S|1-866-234-2345.||
0557|066|B|||
0557|067|P|PRECAUTIONS:  Before using nystatin, tell your doctor or||
0557|068|P|pharmacist if you are allergic to it; or if you have any other||
0557|069|P|allergies. This product may contain inactive ingredients, which||
0557|070|P|can cause allergic reactions or other problems. Talk to your||
0557|071|P|pharmacist for more details.||
0557|072|P|   Before using this medication, tell your doctor or pharmacist||
0557|073|P|your medical history.||
0557|074|P|   This medication should be used with caution during pregnancy||
0557|075|P|and only when clearly needed. Check with your doctor before using||
0557|076|P|the applicator if you are or think you may be pregnant. Discuss||
0557|077|P|the risks and benefits with your doctor.||
0557|078|P|   It is unknown if this drug passes into breast milk. Consult||
0557|079|P|your doctor before breastfeeding.||
0557|080|B|||
0557|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0557|082|I|medications work or increase your risk for serious side effects.||
0557|083|I|This document does not contain all possible drug interactions.||
0557|084|I|Keep a list of all the products you use (including||
0557|085|I|prescription/nonprescription drugs and herbal products) and share||
0557|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
0557|087|I|the dosage of any medicines without your doctor's approval.||
0557|088|B|||
0557|089|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0557|090|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0557|091|O|poison control center right away. US residents can call||
0557|092|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0557|093|O|medication may be harmful if swallowed.||
0557|094|B|||
0557|095|N|NOTES:  Do not share this medication with others.||
0557|096|N|   This medication has been prescribed for your current condition||
0557|097|N|only. Do not use it later for another infection unless your||
0557|098|N|doctor tells you to.||
0557|099|B|||
0557|100|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0557|101|D|If it is near the time of the next dose, skip the missed dose.||
0557|102|D|Use your next dose at the regular time. Do not double the dose to||
0557|103|D|catch up.||
0557|104|B|||
0557|105|R|STORAGE:  Store at room temperature. Keep all medications away||
0557|106|R|from children and pets.||
0557|107|R|   Do not flush medications down the toilet or pour them into a||
0557|108|R|drain unless instructed to do so. Properly discard this product||
0557|109|R|when it is expired or no longer needed. Consult your pharmacist||
0557|110|R|or local waste disposal company.||
0557|111|B|||
0557|112|A|Information last revised October 2024.||
0557|113|A|Copyright(c) 2025 First Databank, Inc.||
0557|114|B|||
0559|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0559|002|Z|does NOT have all possible information about this product. This||
0559|003|Z|information does not assure that this product is safe, effective,||
0559|004|Z|or appropriate for you. This information is not individual||
0559|005|Z|medical advice and does not substitute for the advice of your||
0559|006|Z|health care professional. Always ask your health care||
0559|007|Z|professional for complete information about this product and your||
0559|008|Z|specific health needs.||
0559|009|B|||
0559|010|T|ETHYL CHLORIDE SPRAY - TOPICAL||
0559|011|F|(ETH-ill KLOR-ide)||
0559|012|B|||
0559|013|U|USES:  This medication is used to prevent pain caused by||
0559|014|U|injections and minor surgical procedures. It is also used for the||
0559|015|U|temporary relief of minor sports injuries. Ethyl chloride also||
0559|016|U|helps to relieve deep muscle pain when used with muscle||
0559|017|U|stretching techniques. Ethyl chloride is a cooling substance that||
0559|018|U|is applied to the skin to numb it.||
0559|019|B|||
0559|020|H|HOW TO USE:  This medication is for use on the skin only. It is||
0559|021|H|applied by a healthcare professional. Do not apply to broken skin||
0559|022|H|or mucous membranes (such as inside the nose or mouth). Do not||
0559|023|H|spray into the eyes. Do not inhale the spray.||
0559|024|H|   This medication is flammable until dry. Avoid smoking or being||
0559|025|H|near open flames or electrical equipment that can spark a fire||
0559|026|H|while this medication is being used and until the medication has||
0559|027|H|dried.||
0559|028|H|   Before applying ethyl chloride to injection and local surgical||
0559|029|H|sites, your healthcare professional will swab the treatment area||
0559|030|H|with an antiseptic. Petroleum jelly may be applied to protect||
0559|031|H|surrounding areas around the surgical site. The ethyl chloride||
0559|032|H|container should be positioned 3-9 inches (8-23 centimeters) away||
0559|033|H|from the skin. If using ethyl chloride in a bottle, it should be||
0559|034|H|held upside down and sprayed onto the area for 3-7 seconds. If||
0559|035|H|using ethyl chloride in an aerosol can, it should be held upright||
0559|036|H|and sprayed onto the area for 4-10 seconds. Your healthcare||
0559|037|H|professional will spray just until the skin starts to turn white,||
0559|038|H|stopping before the skin frosts. The procedure will then be||
0559|039|H|quickly performed because the numbing effect of ethyl chloride||
0559|040|H|only lasts for a few seconds to a minute.||
0559|041|H|   For the relief of deep muscle pain, the healthcare||
0559|042|H|professional will hold the container 12-18 inches (30-46||
0559|043|H|centimeters) away from the muscle, then spray in a sweeping||
0559|044|H|motion at the rate of 4 inches (10.2 centimeters) per second||
0559|045|H|until the entire muscle is covered from the trigger point to the||
0559|046|H|area of pain. The muscle will be slowly stretched during this||
0559|047|H|process until full motion is restored and pain is relieved.||
0559|048|B|||
0559|049|S|SIDE EFFECTS:  Side effects are not common with this medication.||
0559|050|S|   Remember that this medication has been prescribed because your||
0559|051|S|doctor has judged that the benefit to you is greater than the||
0559|052|S|risk of side effects. Many people using this medication do not||
0559|053|S|have serious side effects.||
0559|054|S|   Tell your doctor right away if you have any serious side||
0559|055|S|effects, including: lasting changes in skin color, pain as skin||
0559|056|S|is thawing, infection at the application site, delayed wound||
0559|057|S|healing.||
0559|058|S|   Tell your doctor right away if you have any very serious side||
0559|059|S|effects (with long-term exposure), including: nausea/vomiting||
0559|060|S|that doesn't stop, yellowing eyes/skin, dark urine,||
0559|061|S|stomach/abdominal pain, unusual tiredness.||
0559|062|S|   A very serious allergic reaction to this drug is rare.||
0559|063|S|However, get medical help right away if you notice any symptoms||
0559|064|S|of a serious allergic reaction, including: rash, itching/swelling||
0559|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0559|066|S|breathing.||
0559|067|S|   This is not a complete list of possible side effects. If you||
0559|068|S|notice other effects not listed above, contact your doctor or||
0559|069|S|pharmacist.||
0559|070|S|   In the US -||
0559|071|S|   Call your doctor for medical advice about side effects. You||
0559|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0559|073|S|www.fda.gov/medwatch.||
0559|074|S|   In Canada - Call your doctor for medical advice about side||
0559|075|S|effects. You may report side effects to Health Canada at||
0559|076|S|1-866-234-2345.||
0559|077|B|||
0559|078|P|PRECAUTIONS:  Before using ethyl chloride, tell your doctor or||
0559|079|P|pharmacist if you are allergic to it; or if you have any other||
0559|080|P|allergies. This product may contain inactive ingredients, which||
0559|081|P|can cause allergic reactions or other problems. Talk to your||
0559|082|P|pharmacist for more details.||
0559|083|P|   Before using this medication, tell your doctor or pharmacist||
0559|084|P|your medical history.||
0559|085|P|   During pregnancy, this medication should be used only when||
0559|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
0559|087|P|   It is unknown if this drug passes into breast milk. Consult||
0559|088|P|your doctor before breastfeeding.||
0559|089|B|||
0559|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0559|091|I|medications work or increase your risk for serious side effects.||
0559|092|I|This document does not contain all possible drug interactions.||
0559|093|I|Keep a list of all the products you use (including||
0559|094|I|prescription/nonprescription drugs and herbal products) and share||
0559|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
0559|096|I|the dosage of any medicines without your doctor's approval.||
0559|097|B|||
0559|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0559|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0559|100|O|poison control center right away. US residents can call||
0559|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0559|102|O|medication may be harmful if inhaled. If accidentally inhaled,||
0559|103|O|you may experience symptoms such as drowsiness, slowed breathing,||
0559|104|O|slow heartbeat.||
0559|105|B|||
0559|106|N|NOTES:  Not applicable.||
0559|107|B|||
0559|108|D|MISSED DOSE:  Not applicable.||
0559|109|B|||
0559|110|R|STORAGE:  Store at room temperature. This medication is||
0559|111|R|flammable. Keep it away from heat and open flame. Keep all||
0559|112|R|medications away from children and pets.||
0559|113|R|   Do not flush medications down the toilet or pour them into a||
0559|114|R|drain unless instructed to do so. Properly discard this product||
0559|115|R|when it is expired or no longer needed. Consult your pharmacist||
0559|116|R|or local waste disposal company.||
0559|117|B|||
0559|118|A|Information last revised July 2025.||
0559|119|A|Copyright(c) 2025 First Databank, Inc.||
0559|120|B|||
0560|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0560|002|Z|does NOT have all possible information about this product. This||
0560|003|Z|information does not assure that this product is safe, effective,||
0560|004|Z|or appropriate for you. This information is not individual||
0560|005|Z|medical advice and does not substitute for the advice of your||
0560|006|Z|health care professional. Always ask your health care||
0560|007|Z|professional for complete information about this product and your||
0560|008|Z|specific health needs.||
0560|009|B|||
0560|010|T|DIMETHYL SULFOXIDE SOLUTION - IRRIGATION||
0560|011|F|(DI-meth-ill SULF-ox-ide)||
0560|012|B|||
0560|013|C|COMMON BRAND NAME(S): Rimso-50||
0560|014|B|||
0560|015|U|USES:  This medication is used to treat a certain bladder||
0560|016|U|condition (interstitial cystitis). Dimethyl sulfoxide is also||
0560|017|U|known as DMSO. It is believed to reduce swelling and pain due to||
0560|018|U|interstitial cystitis and may improve blood supply to the treated||
0560|019|U|area.||
0560|020|B|||
0560|021|H|HOW TO USE:  This medication is placed into the bladder, usually||
0560|022|H|through a tube (catheter device). The medication is kept in the||
0560|023|H|bladder for at least 15 minutes or as directed by your doctor.||
0560|024|H|After this time, urinate to remove the drug from the bladder.||
0560|025|H|   This treatment is usually repeated every two weeks until||
0560|026|H|relief of symptoms occurs. Follow your doctor's instructions||
0560|027|H|carefully.||
0560|028|H|   This medication is not meant to be given in any other way such||
0560|029|H|as injection into a vein, muscle, or joint. Also, DMSO should not||
0560|030|H|be placed into the bladder at the same time as any other||
0560|031|H|medications.||
0560|032|H|   Tell your doctor if your condition lasts or gets worse.||
0560|033|B|||
0560|034|S|SIDE EFFECTS:  Bladder pain and discomfort may occur. A||
0560|035|S|garlic-like taste in the mouth may be noticed within minutes of||
0560|036|S|placing this medication in the bladder. This taste may last||
0560|037|S|several hours, and an odor on the breath or from the skin may be||
0560|038|S|noticed for up to 3 days following use of this medication. If any||
0560|039|S|of these effects last or get worse, notify your doctor or||
0560|040|S|pharmacist promptly.||
0560|041|S|   Remember that this medication has been prescribed because your||
0560|042|S|doctor has judged that the benefit to you is greater than the||
0560|043|S|risk of side effects. Many people using this medication do not||
0560|044|S|have serious side effects.||
0560|045|S|   Tell your doctor right away if you have any serious side||
0560|046|S|effects, including: vision changes.||
0560|047|S|   A very serious allergic reaction to this drug is rare.||
0560|048|S|However, get medical help right away if you notice any symptoms||
0560|049|S|of a serious allergic reaction, including: rash, itching/swelling||
0560|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0560|051|S|breathing.||
0560|052|S|   This is not a complete list of possible side effects. If you||
0560|053|S|notice other effects not listed above, contact your doctor or||
0560|054|S|pharmacist.||
0560|055|S|   In the US -||
0560|056|S|   Call your doctor for medical advice about side effects. You||
0560|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0560|058|S|www.fda.gov/medwatch.||
0560|059|S|   In Canada - Call your doctor for medical advice about side||
0560|060|S|effects. You may report side effects to Health Canada at||
0560|061|S|1-866-234-2345.||
0560|062|B|||
0560|063|P|PRECAUTIONS:  Before using dimethyl sulfoxide, tell your doctor||
0560|064|P|or pharmacist if you are allergic to it; or if you have any other||
0560|065|P|allergies. This product may contain inactive ingredients, which||
0560|066|P|can cause allergic reactions or other problems. Talk to your||
0560|067|P|pharmacist for more details.||
0560|068|P|   Before using this medication, tell your doctor or pharmacist||
0560|069|P|your medical history, especially of: cancer of the urinary tract.||
0560|070|P|   During pregnancy, this medication should be used only when||
0560|071|P|clearly needed. Discuss the risks and benefits with your doctor.||
0560|072|P|   It is unknown if this drug passes into breast milk. Consult||
0560|073|P|your doctor before breastfeeding.||
0560|074|B|||
0560|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0560|076|I|medications work or increase your risk for serious side effects.||
0560|077|I|This document does not contain all possible drug interactions.||
0560|078|I|Keep a list of all the products you use (including||
0560|079|I|prescription/nonprescription drugs and herbal products) and share||
0560|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
0560|081|I|the dosage of any medicines without your doctor's approval.||
0560|082|B|||
0560|083|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0560|084|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0560|085|O|poison control center right away. US residents can call||
0560|086|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
0560|087|O|medicine may be harmful if swallowed.||
0560|088|B|||
0560|089|N|NOTES:  Do not share this medication with others.||
0560|090|N|   Lab and/or medical tests (such as liver/kidney function,||
0560|091|N|complete blood counts, eye exams) should be done while you are||
0560|092|N|using this medication. Keep all medical and lab appointments.||
0560|093|N|Consult your doctor for more details.||
0560|094|B|||
0560|095|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0560|096|D|If it is near the time of the next dose, skip the missed dose.||
0560|097|D|Use your next dose at the regular time. Do not double the dose to||
0560|098|D|catch up.||
0560|099|B|||
0560|100|R|STORAGE:  Store at room temperature away from light. Keep all||
0560|101|R|medications away from children and pets.||
0560|102|R|   Do not flush medications down the toilet or pour them into a||
0560|103|R|drain unless instructed to do so. Properly discard this product||
0560|104|R|when it is expired or no longer needed. Consult your pharmacist||
0560|105|R|or local waste disposal company.||
0560|106|B|||
0560|107|A|Information last revised January 2025.||
0560|108|A|Copyright(c) 2025 First Databank, Inc.||
0560|109|B|||
0562|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0562|002|Z|does NOT have all possible information about this product. This||
0562|003|Z|information does not assure that this product is safe, effective,||
0562|004|Z|or appropriate for you. This information is not individual||
0562|005|Z|medical advice and does not substitute for the advice of your||
0562|006|Z|health care professional. Always ask your health care||
0562|007|Z|professional for complete information about this product and your||
0562|008|Z|specific health needs.||
0562|009|B|||
0562|010|T|TIMOLOL - ORAL||
0562|011|F|(TIH-moe-lole)||
0562|012|B|||
0562|013|C|COMMON BRAND NAME(S): Blocadren||
0562|014|B|||
0562|015|W|WARNING:  Do not stop taking this medication without consulting||
0562|016|W|your doctor. Some conditions may become worse when you suddenly||
0562|017|W|stop this drug. Some people who have suddenly stopped taking||
0562|018|W|similar drugs have had chest pain, heart attack, and irregular||
0562|019|W|heartbeat. If your doctor decides you should no longer use this||
0562|020|W|drug, your doctor may direct you to gradually decrease your dose||
0562|021|W|over 1 to 2 weeks.||
0562|022|W|   When gradually stopping this medication, it is recommended||
0562|023|W|that you temporarily limit physical activity to decrease strain||
0562|024|W|on the heart. Get medical help right away if you develop chest||
0562|025|W|pain/tightness/pressure, chest pain spreading to the||
0562|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
0562|027|W|fast/irregular heartbeat.||
0562|028|B|||
0562|029|U|USES:  Timolol is used with or without other medications to treat||
0562|030|U|high blood pressure (hypertension). Lowering high blood pressure||
0562|031|U|helps prevent strokes, heart attacks, and kidney problems. This||
0562|032|U|medication is also used after a heart attack to help prevent||
0562|033|U|another heart attack from occurring.||
0562|034|U|   This medication belongs to a class of drugs known as beta||
0562|035|U|blockers. It works by blocking the action of certain natural||
0562|036|U|chemicals in your body such as epinephrine on the heart and blood||
0562|037|U|vessels. This effect lowers the heart rate, blood pressure, and||
0562|038|U|strain on the heart.||
0562|039|U|   This medication is also used to prevent migraine headaches.||
0562|040|B|||
0562|041|V|OTHER USES:  This section contains uses of this drug that are not||
0562|042|V|listed in the approved professional labeling for the drug but||
0562|043|V|that may be prescribed by your health care professional. Use this||
0562|044|V|drug for a condition that is listed in this section only if it||
0562|045|V|has been so prescribed by your health care professional.||
0562|046|V|   This drug may also be used to reduce the risk of chest pain||
0562|047|V|(chronic stable angina).||
0562|048|B|||
0562|049|H|HOW TO USE:  See also Warning section.||
0562|050|H|   Take this medication by mouth with or without food as directed||
0562|051|H|by your doctor, usually once or twice a day. The dosage is based||
0562|052|H|on your medical condition and response to treatment.||
0562|053|H|   Use this medication regularly to get the most benefit from it.||
0562|054|H|To help you remember, take it at the same time(s) each day.||
0562|055|H|   For the treatment of high blood pressure, it may take several||
0562|056|H|weeks before you get the full benefit of this drug. Keep taking||
0562|057|H|this medication even if you feel well. Most people with high||
0562|058|H|blood pressure do not feel sick.||
0562|059|H|   To prevent chest pain or migraine headaches, it is very||
0562|060|H|important to take this medication regularly as prescribed. This||
0562|061|H|drug should not be used to treat chest pain or migraines when||
0562|062|H|they occur. Use other medications to relieve sudden attacks as||
0562|063|H|directed by your doctor (for example, nitroglycerin tablets||
0562|064|H|placed under the tongue for chest pain, "triptan" drugs such as||
0562|065|H|sumatriptan for migraines). Consult your doctor or pharmacist for||
0562|066|H|details.||
0562|067|H|   Tell your doctor if your condition does not get better or if||
0562|068|H|it gets worse (for example, your blood pressure readings remain||
0562|069|H|high or increase, your chest pain or migraines occur more often).||
0562|070|B|||
0562|071|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
0562|072|S|   Tiredness, slow heartbeat, and dizziness may occur. Decreased||
0562|073|S|sexual ability has been reported rarely. If any of these effects||
0562|074|S|last or get worse, tell your doctor or pharmacist promptly.||
0562|075|S|   To reduce the risk of dizziness and lightheadedness, get up||
0562|076|S|slowly when rising from a sitting or lying position.||
0562|077|S|   This drug may reduce blood flow to your hands and feet,||
0562|078|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0562|079|S|warmly and avoid tobacco use.||
0562|080|S|   Remember that this medication has been prescribed because your||
0562|081|S|doctor has judged that the benefit to you is greater than the||
0562|082|S|risk of side effects. Many people using this medication do not||
0562|083|S|have serious side effects.||
0562|084|S|   Tell your doctor right away if you have any serious side||
0562|085|S|effects, including: very slow heartbeat, fainting, blue||
0562|086|S|fingers/toes, new or worsening symptoms of heart failure (such as||
0562|087|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
0562|088|S|unusual/sudden weight gain), mental/mood changes (such as||
0562|089|S|confusion, mood swings, depression).||
0562|090|S|   A very serious allergic reaction to this drug is rare.||
0562|091|S|However, get medical help right away if you notice any symptoms||
0562|092|S|of a serious allergic reaction, including: rash, itching/swelling||
0562|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0562|094|S|breathing.||
0562|095|S|   This is not a complete list of possible side effects. If you||
0562|096|S|notice other effects not listed above, contact your doctor or||
0562|097|S|pharmacist.||
0562|098|S|   In the US -||
0562|099|S|   Call your doctor for medical advice about side effects. You||
0562|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0562|101|S|www.fda.gov/medwatch.||
0562|102|S|   In Canada - Call your doctor for medical advice about side||
0562|103|S|effects. You may report side effects to Health Canada at||
0562|104|S|1-866-234-2345.||
0562|105|B|||
0562|106|P|PRECAUTIONS:  Before taking timolol, tell your doctor or||
0562|107|P|pharmacist if you are allergic to it; or if you have any other||
0562|108|P|allergies. This product may contain inactive ingredients, which||
0562|109|P|can cause allergic reactions or other problems. Talk to your||
0562|110|P|pharmacist for more details.||
0562|111|P|   Before using this medication, tell your doctor or pharmacist||
0562|112|P|your medical history, especially of: certain types of heart||
0562|113|P|rhythm problems (such as a slow heartbeat, second- or||
0562|114|P|third-degree atrioventricular block), heart failure, breathing||
0562|115|P|problems (such as asthma, chronic bronchitis, emphysema), kidney||
0562|116|P|disease, liver disease, overactive thyroid disease||
0562|117|P|(hyperthyroidism), serious allergic reactions including those||
0562|118|P|needing treatment with epinephrine, blood circulation problems||
0562|119|P|(such as Raynaud's disease, peripheral vascular disease),||
0562|120|P|mental/mood disorders (such as depression), a certain muscle||
0562|121|P|disease (myasthenia gravis).||
0562|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0562|123|P|can make you more dizzy. Do not drive, use machinery, or do||
0562|124|P|anything that needs alertness until you can do it safely. Limit||
0562|125|P|alcoholic beverages. Talk to your doctor if you are using||
0562|126|P|marijuana (cannabis).||
0562|127|P|   Before having surgery, tell your doctor or dentist about all||
0562|128|P|the products you use (including prescription drugs,||
0562|129|P|nonprescription drugs, and herbal products).||
0562|130|P|   This product may prevent the fast/pounding heartbeat you would||
0562|131|P|usually feel when your blood sugar level falls too low||
0562|132|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0562|133|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0562|134|P|blood sugar level, such as dizziness and sweating, are not||
0562|135|P|affected by this drug.||
0562|136|P|   If you have diabetes, this product may make it harder to||
0562|137|P|control your blood sugar levels. Check your blood sugar levels||
0562|138|P|regularly as directed by your doctor. Tell your doctor right away||
0562|139|P|if you have symptoms of high blood sugar such as increased||
0562|140|P|thirst/urination. Your doctor may need to adjust your diabetes||
0562|141|P|medication, exercise program, or diet.||
0562|142|P|   Children may be at greater risk for low blood sugar||
0562|143|P|(hypoglycemia) while using this drug, especially if they are||
0562|144|P|vomiting or not eating regularly. To help prevent low blood||
0562|145|P|sugar, make sure children eat regularly. If your child cannot eat||
0562|146|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
0562|147|P|as sweating, shaking), tell the doctor right away.||
0562|148|P|   Older adults may be more sensitive to the side effects of this||
0562|149|P|drug, including dizziness and tiredness.||
0562|150|P|   During pregnancy, this medication should be used only when||
0562|151|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0562|152|P|benefits with your doctor.||
0562|153|P|   This medication passes into breast milk and may have||
0562|154|P|undesirable effects on a nursing infant. Consult your doctor||
0562|155|P|before breastfeeding.||
0562|156|B|||
0562|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0562|158|I|medications work or increase your risk for serious side effects.||
0562|159|I|This document does not contain all possible drug interactions.||
0562|160|I|Keep a list of all the products you use (including||
0562|161|I|prescription/nonprescription drugs and herbal products) and share||
0562|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
0562|163|I|the dosage of any medicines without your doctor's approval.||
0562|164|I|   A product that may interact with this drug is: fingolimod.||
0562|165|I|   Some products have ingredients that could raise your heart||
0562|166|I|rate or blood pressure. Tell your pharmacist what products you||
0562|167|I|are using, and ask how to use them safely (especially||
0562|168|I|cough-and-cold products, diet aids, or NSAIDs such as||
0562|169|I|ibuprofen/naproxen).||
0562|170|B|||
0562|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0562|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0562|173|O|poison control center right away. US residents can call||
0562|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0562|175|O|Symptoms of overdose may include: very slow heartbeat, severe||
0562|176|O|dizziness, severe weakness, fainting, trouble breathing.||
0562|177|B|||
0562|178|N|NOTES:  Do not share this medication with others.||
0562|179|N|   Talk with your doctor about making changes to your lifestyle||
0562|180|N|that may help this medication work better (such as stress||
0562|181|N|reduction programs, exercise, and dietary changes).||
0562|182|N|   Have your blood pressure and pulse (heart rate) checked||
0562|183|N|regularly while taking this medication. Learn how to check your||
0562|184|N|own blood pressure and pulse at home, and share the results with||
0562|185|N|your doctor.||
0562|186|N|   Lab and/or medical tests should be done while you are taking||
0562|187|N|this medication. Keep all medical and lab appointments. Consult||
0562|188|N|your doctor for more details.||
0562|189|B|||
0562|190|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0562|191|D|remember. If it is near the time of the next dose, skip the||
0562|192|D|missed dose. Take your next dose at the regular time. Do not||
0562|193|D|double the dose to catch up.||
0562|194|B|||
0562|195|R|STORAGE:  Store at room temperature away from light and moisture.||
0562|196|R|Do not store in the bathroom. Keep all medications away from||
0562|197|R|children and pets.||
0562|198|R|   Do not flush medications down the toilet or pour them into a||
0562|199|R|drain unless instructed to do so. Properly discard this product||
0562|200|R|when it is expired or no longer needed. Consult your pharmacist||
0562|201|R|or local waste disposal company.||
0562|202|B|||
0562|203|A|Information last revised May 2024.||
0562|204|A|Copyright(c) 2025 First Databank, Inc.||
0562|205|B|||
0563|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0563|002|Z|does NOT have all possible information about this product. This||
0563|003|Z|information does not assure that this product is safe, effective,||
0563|004|Z|or appropriate for you. This information is not individual||
0563|005|Z|medical advice and does not substitute for the advice of your||
0563|006|Z|health care professional. Always ask your health care||
0563|007|Z|professional for complete information about this product and your||
0563|008|Z|specific health needs.||
0563|009|B|||
0563|010|T|ENALAPRIL/HYDROCHLOROTHIAZIDE - ORAL||
0563|011|F|(e-NAL-a-pril/HYE-droe-KLOR-oh-THYE-a-zide)||
0563|012|B|||
0563|013|C|COMMON BRAND NAME(S): Vaseretic||
0563|014|B|||
0563|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
0563|016|W|unborn baby if used during pregnancy. It is important to prevent||
0563|017|W|pregnancy while taking this medication. Consult your doctor for||
0563|018|W|more details and to discuss the use of reliable forms of birth||
0563|019|W|control while taking this medication. If you are planning||
0563|020|W|pregnancy, become pregnant or think you may be pregnant, contact||
0563|021|W|your doctor right away.||
0563|022|B|||
0563|023|U|USES:  This medication is used to treat high blood pressure||
0563|024|U|(hypertension). Lowering high blood pressure helps prevent||
0563|025|U|strokes, heart attacks, and kidney problems. This product||
0563|026|U|contains 2 medications, enalapril and hydrochlorothiazide.||
0563|027|U|Enalapril belongs to a class of drugs known as ACE inhibitors. It||
0563|028|U|works by relaxing blood vessels so that blood can flow through||
0563|029|U|the body more easily. Hydrochlorothiazide is a "water pill"||
0563|030|U|(diuretic) and causes your body to get rid of extra salt and||
0563|031|U|water. This effect may increase the amount of urine you make when||
0563|032|U|you first start the medication. It also helps to relax the blood||
0563|033|U|vessels so that blood can flow through the body more easily.||
0563|034|B|||
0563|035|V|OTHER USES:  This section contains uses of this drug that are not||
0563|036|V|listed in the approved professional labeling for the drug but||
0563|037|V|that may be prescribed by your health care professional. Use this||
0563|038|V|drug for a condition that is listed in this section only if it||
0563|039|V|has been so prescribed by your health care professional.||
0563|040|V|   This drug may also be used for heart failure.||
0563|041|B|||
0563|042|H|HOW TO USE:  Take this medication by mouth with or without food||
0563|043|H|as directed by your doctor, usually once daily. If you take this||
0563|044|H|product too close to bedtime, you may need to wake up to urinate.||
0563|045|H|It is best to take this medication at least 4 hours before your||
0563|046|H|bedtime. Consult your doctor or pharmacist if you have questions||
0563|047|H|about your dosing schedule.||
0563|048|H|   If you are also taking cholestyramine or colestipol, take||
0563|049|H|enalapril/hydrochlorothiazide at least 4 hours before or at least||
0563|050|H|4 to 6 hours after either of those drugs.||
0563|051|H|   The dosage is based on your medical condition and response to||
0563|052|H|treatment.||
0563|053|H|   Use this medication regularly to get the most benefit from it.||
0563|054|H|To help you remember, take it at the same time each day.||
0563|055|H|   It may take several weeks before you get the full benefit of||
0563|056|H|this medication. Keep taking this medication even if you feel||
0563|057|H|well. Most people with high blood pressure do not feel sick.||
0563|058|H|   Tell your doctor if your condition does not get better or if||
0563|059|H|it gets worse (your blood pressure readings remain high or||
0563|060|H|increase).||
0563|061|B|||
0563|062|S|SIDE EFFECTS:  Dizziness, lightheadedness, or tiredness may occur||
0563|063|S|as your body adjusts to the medication. Dry cough may also occur.||
0563|064|S|If any of these effects last or get worse, tell your doctor or||
0563|065|S|pharmacist promptly.||
0563|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
0563|067|S|slowly when rising from a sitting or lying position.||
0563|068|S|   Remember that this medication has been prescribed because your||
0563|069|S|doctor has judged that the benefit to you is greater than the||
0563|070|S|risk of side effects. Many people using this medication do not||
0563|071|S|have serious side effects.||
0563|072|S|   This product may cause dehydration and electrolyte imbalance.||
0563|073|S|Tell your doctor right away if you have any symptoms of||
0563|074|S|dehydration or electrolyte imbalance, including unusual dry||
0563|075|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0563|076|S|heartbeat, or confusion.||
0563|077|S|   Tell your doctor right away if you have any serious side||
0563|078|S|effects, including: toe/joint pain, irregular heartbeat, decrease||
0563|079|S|in vision, eye pain, fainting, easy bruising/bleeding, signs of||
0563|080|S|kidney problems (such as change in the amount of urine).||
0563|081|S|   This drug may rarely cause serious (possibly fatal) liver||
0563|082|S|problems. Get medical help right away if you have any symptoms of||
0563|083|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0563|084|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0563|085|S|urine.||
0563|086|S|   A very serious allergic reaction to this drug is rare.||
0563|087|S|However, get medical help right away if you notice any symptoms||
0563|088|S|of a serious allergic reaction, including: rash, itching/swelling||
0563|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0563|090|S|breathing.||
0563|091|S|   This is not a complete list of possible side effects. If you||
0563|092|S|notice other effects not listed above, contact your doctor or||
0563|093|S|pharmacist.||
0563|094|S|   In the US -||
0563|095|S|   Call your doctor for medical advice about side effects. You||
0563|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0563|097|S|www.fda.gov/medwatch.||
0563|098|S|   In Canada - Call your doctor for medical advice about side||
0563|099|S|effects. You may report side effects to Health Canada at||
0563|100|S|1-866-234-2345.||
0563|101|B|||
0563|102|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0563|103|P|pharmacist if you are allergic to either enalapril or||
0563|104|P|hydrochlorothiazide; or to other ACE inhibitors (such as||
0563|105|P|captopril, lisinopril); or to other thiazides (such as||
0563|106|P|chlorothiazide); or if you have any other allergies. This product||
0563|107|P|may contain inactive ingredients, which can cause allergic||
0563|108|P|reactions or other problems. Talk to your pharmacist for more||
0563|109|P|details.||
0563|110|P|   Before using this medication, tell your doctor or pharmacist||
0563|111|P|your medical history, especially of: a history of an allergic||
0563|112|P|reaction that included swelling of the face/lips/tongue/throat||
0563|113|P|(angioedema), kidney disease (such as renal artery stenosis),||
0563|114|P|liver disease, lupus, gout, untreated salt imbalance (such as||
0563|115|P|high calcium, high or low potassium, low magnesium), dehydration,||
0563|116|P|blood filtering procedures (such as LDL apheresis, dialysis),||
0563|117|P|skin cancer.||
0563|118|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0563|119|P|can make you more dizzy. Do not drive, use machinery, or do||
0563|120|P|anything that needs alertness until you can do it safely. Limit||
0563|121|P|alcoholic beverages. Talk to your doctor if you are using||
0563|122|P|marijuana (cannabis).||
0563|123|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0563|124|P|and cause you to feel lightheaded. Tell your doctor if you have||
0563|125|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0563|126|P|of fluids unless your doctor tells you not to.||
0563|127|P|   Before having surgery, tell your doctor or dentist about all||
0563|128|P|the products you use (including prescription drugs,||
0563|129|P|nonprescription drugs, and herbal products).||
0563|130|P|   This medication may make you more sensitive to the sun. It may||
0563|131|P|also increase your risk for skin cancer, especially if you take||
0563|132|P|it for a long time. Limit your time in the sun. Avoid tanning||
0563|133|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0563|134|P|when outdoors. Tell your doctor right away if you get sunburned,||
0563|135|P|have skin blisters/redness, or notice new or changed moles/skin||
0563|136|P|lesions.||
0563|137|P|   This product may affect your potassium levels. Before using||
0563|138|P|potassium supplements or salt substitutes that contain potassium,||
0563|139|P|consult your doctor or pharmacist.||
0563|140|P|   If you have diabetes, this product may affect your blood||
0563|141|P|sugar. Check your blood sugar regularly as directed and share the||
0563|142|P|results with your doctor. Tell your doctor right away if you have||
0563|143|P|symptoms of high blood sugar such as increased thirst/urination,||
0563|144|P|or signs of low blood sugar such as sudden sweating, shaking,||
0563|145|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
0563|146|P|hands/feet. Your doctor may need to adjust your diabetes||
0563|147|P|medication, exercise program, or diet.||
0563|148|P|   Older adults may be more sensitive to the side effects of this||
0563|149|P|drug, especially dizziness and change in the amount of urine||
0563|150|P|(kidney problems).||
0563|151|P|   Tell your doctor if you are pregnant or plan to become||
0563|152|P|pregnant. You should not become pregnant while using||
0563|153|P|enalapril/hydrochlorothiazide. Enalapril/hydrochlorothiazide may||
0563|154|P|harm an unborn baby. If you become pregnant, talk to your doctor||
0563|155|P|right away about the risks and benefits of this medication. (See||
0563|156|P|also Warning section.)||
0563|157|P|   The product passes into breast milk, but it is unlikely to||
0563|158|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0563|159|B|||
0563|160|I|DRUG INTERACTIONS:  See also Precautions section.||
0563|161|I|   Drug interactions may change how your medications work or||
0563|162|I|increase your risk for serious side effects. This document does||
0563|163|I|not contain all possible drug interactions. Keep a list of all||
0563|164|I|the products you use (including prescription/nonprescription||
0563|165|I|drugs and herbal products) and share it with your doctor and||
0563|166|I|pharmacist. Do not start, stop, or change the dosage of any||
0563|167|I|medicines without your doctor's approval.||
0563|168|I|   Some products that may interact with this drug are: aliskiren,||
0563|169|I|dofetilide, certain drugs that weaken the immune system/increase||
0563|170|I|the risk of infection (such as everolimus, sirolimus), gold||
0563|171|I|injections, lithium, drugs that may increase the level of||
0563|172|I|potassium in the blood (such as ARBs including||
0563|173|I|losartan/valsartan, birth control pills containing drospirenone),||
0563|174|I|sacubitril.||
0563|175|I|   A very serious reaction may occur if you are getting||
0563|176|I|injections for bee/wasp sting allergy (desensitization) and are||
0563|177|I|also taking enalapril/hydrochlorothiazide. Make sure all your||
0563|178|I|doctors know which medicines you are using.||
0563|179|I|   Some products have ingredients that could raise your blood||
0563|180|I|pressure or worsen your heart failure. Tell your pharmacist what||
0563|181|I|products you are using, and ask how to use them safely||
0563|182|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0563|183|I|ibuprofen/naproxen).||
0563|184|I|   This medication may interfere with certain lab tests||
0563|185|I|(including parathyroid, protein-bound iodide, tyramine, and||
0563|186|I|phentolamine tests), possibly causing false test results. Make||
0563|187|I|sure lab personnel and all your doctors know you use this drug.||
0563|188|B|||
0563|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0563|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0563|191|O|poison control center right away. US residents can call||
0563|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0563|193|O|Symptoms of overdose may include: severe dizziness.||
0563|194|B|||
0563|195|N|NOTES:  Do not share this medication with others.||
0563|196|N|   Talk with your doctor about making changes to your lifestyle||
0563|197|N|that may help this medication work better (such as stress||
0563|198|N|reduction programs, exercise, and dietary changes).||
0563|199|N|   Lab and/or medical tests (such as kidney/liver function, blood||
0563|200|N|mineral levels such as potassium, skin exams, cholesterol levels)||
0563|201|N|should be done while you are taking this medication. Keep all||
0563|202|N|medical and lab appointments. Consult your doctor for more||
0563|203|N|details.||
0563|204|N|   Have your blood pressure checked regularly while taking this||
0563|205|N|medication. Learn how to check your own blood pressure at home,||
0563|206|N|and share the results with your doctor.||
0563|207|B|||
0563|208|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0563|209|D|remember. If it is near the time of the next dose, skip the||
0563|210|D|missed dose. Take your next dose at the regular time. Do not||
0563|211|D|double the dose to catch up.||
0563|212|B|||
0563|213|R|STORAGE:  Store at room temperature away from light and moisture.||
0563|214|R|Do not store in the bathroom. Keep all medications away from||
0563|215|R|children and pets.||
0563|216|R|   Do not flush medications down the toilet or pour them into a||
0563|217|R|drain unless instructed to do so. Properly discard this product||
0563|218|R|when it is expired or no longer needed. Consult your pharmacist||
0563|219|R|or local waste disposal company.||
0563|220|B|||
0563|221|A|Information last revised March 2025.||
0563|222|A|Copyright(c) 2025 First Databank, Inc.||
0563|223|B|||
0564|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0564|002|Z|does NOT have all possible information about this product. This||
0564|003|Z|information does not assure that this product is safe, effective,||
0564|004|Z|or appropriate for you. This information is not individual||
0564|005|Z|medical advice and does not substitute for the advice of your||
0564|006|Z|health care professional. Always ask your health care||
0564|007|Z|professional for complete information about this product and your||
0564|008|Z|specific health needs.||
0564|009|B|||
0564|010|T|DEFERASIROX TABLET - FOR ORAL SUSPENSION||
0564|011|F|(deaf-ur-ES-ur-ox)||
0564|012|B|||
0564|013|C|COMMON BRAND NAME(S): Exjade||
0564|014|B|||
0564|015|W|WARNING:  Deferasirox may rarely cause serious (even fatal)||
0564|016|W|kidney disease, liver disease, and stomach/intestinal bleeding||
0564|017|W|(see also Side Effects section). Kidney disease may be more||
0564|018|W|likely to occur in people with kidney problems and in people with||
0564|019|W|serious blood diseases. Liver disease may be more likely to occur||
0564|020|W|in people with liver problems (such as cirrhosis) and in older||
0564|021|W|adults. Stomach/intestinal bleeding may be more likely to occur||
0564|022|W|in older adults with serious blood diseases (including blood||
0564|023|W|cancers). Consult your doctor for more details.||
0564|024|W|   Your doctor will monitor you closely while you are taking this||
0564|025|W|medication. Keep all regular medical and lab appointments.||
0564|026|B|||
0564|027|U|USES:  This medication is used to treat ongoing high levels of||
0564|028|U|iron in the body caused by multiple blood transfusions. It is||
0564|029|U|also used to treat high levels of iron in people with a certain||
0564|030|U|blood disorder who do not require blood transfusions||
0564|031|U|(non-transfusion-dependent thalassemia). It works by binding to||
0564|032|U|iron, allowing the body to pass extra iron out in the stool.||
0564|033|U|Deferasirox belongs to a class of drugs known as iron-chelating||
0564|034|U|agents.||
0564|035|U|   Frequent blood transfusions are often needed in certain types||
0564|036|U|of blood diseases (such as sickle cell disease, anemia). Blood||
0564|037|U|transfusions have very helpful benefits, but they can cause the||
0564|038|U|body to hold on to too much iron. The extra iron can build up in||
0564|039|U|the body and cause problems such as heart failure, liver disease,||
0564|040|U|and diabetes. Getting rid of extra iron can decrease the risk of||
0564|041|U|these diseases.||
0564|042|B|||
0564|043|H|HOW TO USE:  Read the Medication Guide provided by your||
0564|044|H|pharmacist before you start taking deferasirox and each time you||
0564|045|H|get a refill. If you have any questions, ask your doctor or||
0564|046|H|pharmacist.||
0564|047|H|   Stir the tablet(s) into water, orange juice or apple juice||
0564|048|H|until the tablets have completely broken apart and are well mixed||
0564|049|H|into the liquid. If your dose is less than 1 gram, stir the||
0564|050|H|tablets into about 1/2 cup (3.5 ounces/100 milliliters) of||
0564|051|H|liquid. If your dose is more than 1 gram, use about 1 cup (7||
0564|052|H|ounces/200 milliliters) of liquid. Drink all of the mixture right||
0564|053|H|away, then add more liquid to the empty container and stir to get||
0564|054|H|any drug that may remain. Drink all of this rinsing liquid right||
0564|055|H|away.||
0564|056|H|   Take this medication by mouth on an empty stomach at least 30||
0564|057|H|minutes before food as directed by your doctor, usually once||
0564|058|H|daily. Do not chew the tablets or swallow them whole. Always mix||
0564|059|H|this medication into liquid as directed.||
0564|060|H|   Antacids that contain aluminum can bind with deferasirox which||
0564|061|H|may affect how deferasirox works. Avoid taking this medication||
0564|062|H|with antacids that contain aluminum.||
0564|063|H|   Use this medication regularly to get the most benefit from it.||
0564|064|H|To help you remember, take it at the same time each day. Do not||
0564|065|H|increase your dose or use this drug more often or for longer than||
0564|066|H|prescribed. Your condition will not improve any faster, and your||
0564|067|H|risk of side effects will increase.||
0564|068|H|   The dosage is based on your medical condition, weight, lab||
0564|069|H|tests, and response to treatment. Your dosage may need to be||
0564|070|H|lowered or your treatment may need to be stopped if you get||
0564|071|H|certain side effects. Follow your doctor's instructions||
0564|072|H|carefully.||
0564|073|B|||
0564|074|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, or dizziness may||
0564|075|S|occur. If any of these effects last or get worse, tell your||
0564|076|S|doctor or pharmacist promptly.||
0564|077|S|   Remember that this medication has been prescribed because your||
0564|078|S|doctor has judged that the benefit to you is greater than the||
0564|079|S|risk of side effects. Many people using this medication do not||
0564|080|S|have serious side effects.||
0564|081|S|   Tell your doctor right away if you have any serious side||
0564|082|S|effects, including: hearing loss, vision changes (such as blurred||
0564|083|S|vision).||
0564|084|S|   This medication decreases bone marrow function, an effect that||
0564|085|S|may lead to a low number of blood cells such as red cells, white||
0564|086|S|cells, and platelets. This effect can worsen anemia, decrease||
0564|087|S|your body's ability to fight an infection, or cause easy||
0564|088|S|bruising/bleeding. Tell your doctor right away if you develop any||
0564|089|S|of the following unlikely symptoms: unusual tiredness, pale skin,||
0564|090|S|signs of infection (such as sore throat that doesn't go away,||
0564|091|S|fever, chills), easy bruising/bleeding.||
0564|092|S|   This drug may rarely cause serious stomach/intestinal problems||
0564|093|S|(such as stomach/intestinal bleeding and ulcers). If you notice||
0564|094|S|any of the following unlikely but serious side effects, stop||
0564|095|S|taking deferasirox and consult your doctor or pharmacist right||
0564|096|S|away: stomach/abdominal pain that doesn't go away, black/bloody||
0564|097|S|stools, vomit that looks like coffee grounds.||
0564|098|S|   Deferasirox may rarely cause serious (possibly fatal) liver||
0564|099|S|disease. Get medical help right away if you have any symptoms of||
0564|100|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0564|101|S|of appetite, stomach/abdominal pain, yellowing of eyes/skin, dark||
0564|102|S|urine.||
0564|103|S|   Deferasirox has rarely caused very serious (possibly fatal)||
0564|104|S|kidney problems. Tell your doctor right away if you develop signs||
0564|105|S|of kidney problems, such as: change in the amount of urine,||
0564|106|S|frothy urine.||
0564|107|S|   Deferasirox can commonly cause a rash that is usually not||
0564|108|S|serious. However, you may not be able to tell it apart from a||
0564|109|S|rare rash that could be a sign of a severe reaction. Get medical||
0564|110|S|help right away if you develop any rash.||
0564|111|S|   A very serious allergic reaction to this drug is rare.||
0564|112|S|However, get medical help right away if you notice any symptoms||
0564|113|S|of a serious allergic reaction, including: rash, itching/swelling||
0564|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0564|115|S|breathing.||
0564|116|S|   This is not a complete list of possible side effects. If you||
0564|117|S|notice other effects not listed above, contact your doctor or||
0564|118|S|pharmacist.||
0564|119|S|   In the US -||
0564|120|S|   Call your doctor for medical advice about side effects. You||
0564|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0564|122|S|www.fda.gov/medwatch.||
0564|123|S|   In Canada - Call your doctor for medical advice about side||
0564|124|S|effects. You may report side effects to Health Canada at||
0564|125|S|1-866-234-2345.||
0564|126|B|||
0564|127|P|PRECAUTIONS:  Before taking deferasirox, tell your doctor or||
0564|128|P|pharmacist if you are allergic to it; or if you have any other||
0564|129|P|allergies. This product may contain inactive ingredients, which||
0564|130|P|can cause allergic reactions or other problems. Talk to your||
0564|131|P|pharmacist for more details.||
0564|132|P|   Before using this medication, tell your doctor or pharmacist||
0564|133|P|your medical history, especially of: kidney disease, liver||
0564|134|P|disease, low platelet counts, advanced cancer, certain bone||
0564|135|P|marrow disorders involving damaged blood-forming cells (high-risk||
0564|136|P|myelodysplastic syndromes).||
0564|137|P|   This drug may make you dizzy or blur your vision. Alcohol or||
0564|138|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
0564|139|P|machinery, or do anything that needs alertness or clear vision||
0564|140|P|until you can do it safely. Limit alcoholic beverages. Talk to||
0564|141|P|your doctor if you are using marijuana (cannabis).||
0564|142|P|   Before having surgery, tell your doctor or dentist about all||
0564|143|P|the products you use (including prescription drugs,||
0564|144|P|nonprescription drugs, and herbal products).||
0564|145|P|   Tell the doctor right away if you develop any illness that may||
0564|146|P|cause dehydration (including fever, diarrhea, or vomiting) or if||
0564|147|P|you are unable to drink fluids. The doctor may need to stop or||
0564|148|P|adjust deferasirox treatment, especially in children.||
0564|149|P|   Children may be more sensitive to the side effects of this||
0564|150|P|drug, especially kidney problems and hearing loss.||
0564|151|P|   Older adults may be more sensitive to the side effects of this||
0564|152|P|drug, especially liver problems, stomach/intestinal bleeding, and||
0564|153|P|ulcers.||
0564|154|P|   Tell your doctor if you are pregnant or plan to become||
0564|155|P|pregnant. You should not become pregnant while using deferasirox.||
0564|156|P|Deferasirox may harm an unborn baby. If you become pregnant, talk||
0564|157|P|to your doctor right away about the risks and benefits of this||
0564|158|P|medication.||
0564|159|P|   It is unknown if this medication passes into breast milk.||
0564|160|P|Because of the possible risk to the infant, breastfeeding is not||
0564|161|P|recommended while using this medication. Consult your doctor||
0564|162|P|before breastfeeding.||
0564|163|B|||
0564|164|I|DRUG INTERACTIONS:  See also How to Use section.||
0564|165|I|   Drug interactions may change how your medications work or||
0564|166|I|increase your risk for serious side effects. This document does||
0564|167|I|not contain all possible drug interactions. Keep a list of all||
0564|168|I|the products you use (including prescription/nonprescription||
0564|169|I|drugs and herbal products) and share it with your doctor and||
0564|170|I|pharmacist. Do not start, stop, or change the dosage of any||
0564|171|I|medicines without your doctor's approval.||
0564|172|I|   Some products that may interact with this drug include:||
0564|173|I|fezolinetant, other drugs that can cause bleeding/bruising||
0564|174|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
0564|175|I|ibuprofen/naproxen, "blood thinners" such as||
0564|176|I|dabigatran/warfarin).||
0564|177|I|   Aspirin can increase the risk of bleeding when used with this||
0564|178|I|medication. However, if your doctor has told you to take low-dose||
0564|179|I|aspirin to prevent heart attack or stroke (usually 81-162||
0564|180|I|milligrams a day), you should keep taking the aspirin unless your||
0564|181|I|doctor tells you not to. Ask your doctor or pharmacist for more||
0564|182|I|details.||
0564|183|I|   This medication can slow down the removal of other medications||
0564|184|I|from your body, which may affect how they work. Examples of||
0564|185|I|affected drugs include tovorafenib, among others.||
0564|186|I|   This medication may decrease the effectiveness of hormonal||
0564|187|I|birth control such as pills, patch, or ring. This could cause||
0564|188|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0564|189|I|use reliable backup birth control methods while using this||
0564|190|I|medication. Also tell your doctor if you have any new spotting or||
0564|191|I|breakthrough bleeding, because these may be signs that your birth||
0564|192|I|control is not working well.||
0564|193|B|||
0564|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0564|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0564|196|O|poison control center right away. US residents can call||
0564|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0564|198|B|||
0564|199|N|NOTES:  Do not share this medication with others.||
0564|200|N|   Lab and/or medical tests (such as serum ferritin, blood||
0564|201|N|counts, urine tests, liver/kidney function, vision/hearing tests,||
0564|202|N|liver iron concentration) must be done before you start taking||
0564|203|N|this medication and while you are taking it. Keep all medical and||
0564|204|N|lab appointments. Consult your doctor for more details.||
0564|205|B|||
0564|206|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0564|207|D|If it is near the time of the next dose, skip the missed dose.||
0564|208|D|Use your next dose at the regular time. Do not double the dose to||
0564|209|D|catch up.||
0564|210|B|||
0564|211|R|STORAGE:  Store at room temperature away from light and moisture.||
0564|212|R|Do not store in the bathroom. Keep all medications away from||
0564|213|R|children and pets.||
0564|214|R|   Do not flush medications down the toilet or pour them into a||
0564|215|R|drain unless instructed to do so. Properly discard this product||
0564|216|R|when it is expired or no longer needed. Consult your pharmacist||
0564|217|R|or local waste disposal company.||
0564|218|B|||
0564|219|A|Information last revised May 2024.||
0564|220|A|Copyright(c) 2025 First Databank, Inc.||
0564|221|B|||
0565|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0565|002|Z|does NOT have all possible information about this product. This||
0565|003|Z|information does not assure that this product is safe, effective,||
0565|004|Z|or appropriate for you. This information is not individual||
0565|005|Z|medical advice and does not substitute for the advice of your||
0565|006|Z|health care professional. Always ask your health care||
0565|007|Z|professional for complete information about this product and your||
0565|008|Z|specific health needs.||
0565|009|B|||
0565|010|T|LANTHANUM CARBONATE CHEWABLE TABLET - ORAL||
0565|011|F|(LAN-tha-num KAR-bo-nate)||
0565|012|B|||
0565|013|C|COMMON BRAND NAME(S): Fosrenol||
0565|014|B|||
0565|015|U|USES:  Lanthanum is used to lower high blood phosphate levels in||
0565|016|U|people who are on dialysis due to severe kidney disease. Dialysis||
0565|017|U|removes some phosphate from your blood, but it is difficult to||
0565|018|U|remove enough to keep your phosphate levels balanced. Decreasing||
0565|019|U|blood phosphate levels can help keep your bones strong, prevent||
0565|020|U|unsafe buildup of minerals in your body, and may decrease the||
0565|021|U|risk of heart disease and strokes that can result from high||
0565|022|U|phosphate levels.||
0565|023|U|   Lanthanum is a natural mineral that works by binding to||
0565|024|U|phosphate in the foods you eat. The phosphate then passes out of||
0565|025|U|your body in your stool.||
0565|026|B|||
0565|027|H|HOW TO USE:  Read the Medication Guide provided by your||
0565|028|H|pharmacist before you start taking lanthanum and each time you||
0565|029|H|get a refill. If you have any questions, ask your doctor or||
0565|030|H|pharmacist.||
0565|031|H|   Take this medication by mouth as directed by your doctor,||
0565|032|H|usually with or right after meals. Chew the tablets completely||
0565|033|H|before swallowing to reduce the risk of stomach/abdominal side||
0565|034|H|effects. You may crush the tablets to make it easier to chew||
0565|035|H|them. Do not swallow the tablets whole. You do not need to||
0565|036|H|swallow this medication with water.||
0565|037|H|   Take this medication regularly to get the most benefit from||
0565|038|H|it. The dosage is based on your medical condition, response to||
0565|039|H|treatment, and lab tests.||
0565|040|H|   Lanthanum may stop some medications from working well if you||
0565|041|H|take them at the same time. Ask your pharmacist if you need to||
0565|042|H|separate the time that you take your other medications from the||
0565|043|H|time that you take lanthanum. See also Drug Interactions section.||
0565|044|B|||
0565|045|S|SIDE EFFECTS:  Nausea, vomiting, stomach pain, diarrhea, or||
0565|046|S|constipation may occur. If any of these effects last or get||
0565|047|S|worse, tell your doctor or pharmacist promptly.||
0565|048|S|   Remember that this medication has been prescribed because your||
0565|049|S|doctor has judged that the benefit to you is greater than the||
0565|050|S|risk of side effects. Many people using this medication do not||
0565|051|S|have serious side effects.||
0565|052|S|   Tell your doctor right away if you have any serious side||
0565|053|S|effects, including: mental/mood changes, unusual muscle||
0565|054|S|weakness/spasms, seizures.||
0565|055|S|   Rarely, a serious blockage of the bowels or a hole in the||
0565|056|S|bowels may occur, which may sometimes require surgery or going to||
0565|057|S|the hospital. Tell your doctor right away if you have:||
0565|058|S|stomach/abdominal pain that is severe or doesn't stop, vomiting||
0565|059|S|that doesn't stop, severe constipation, severe diarrhea, fever,||
0565|060|S|chills.||
0565|061|S|   A very serious allergic reaction to this drug is rare.||
0565|062|S|However, get medical help right away if you notice any symptoms||
0565|063|S|of a serious allergic reaction, including: rash, itching/swelling||
0565|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0565|065|S|breathing.||
0565|066|S|   This is not a complete list of possible side effects. If you||
0565|067|S|notice other effects not listed above, contact your doctor or||
0565|068|S|pharmacist.||
0565|069|S|   In the US -||
0565|070|S|   Call your doctor for medical advice about side effects. You||
0565|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0565|072|S|www.fda.gov/medwatch.||
0565|073|S|   In Canada - Call your doctor for medical advice about side||
0565|074|S|effects. You may report side effects to Health Canada at||
0565|075|S|1-866-234-2345.||
0565|076|B|||
0565|077|P|PRECAUTIONS:  Before taking lanthanum, tell your doctor or||
0565|078|P|pharmacist if you are allergic to it; or if you have any other||
0565|079|P|allergies. This product may contain inactive ingredients, which||
0565|080|P|can cause allergic reactions or other problems. Talk to your||
0565|081|P|pharmacist for more details.||
0565|082|P|   Before using this medication, tell your doctor or pharmacist||
0565|083|P|your medical history, especially of: stomach/intestinal problems||
0565|084|P|(such as ulcers, bowel blockage/surgery, cancer, constipation),||
0565|085|P|diabetes.||
0565|086|P|   Before having stomach/abdomen imaging (such as X-rays), tell||
0565|087|P|the medical personnel and all your doctors that you are taking||
0565|088|P|this medication.||
0565|089|P|   Before having surgery, tell your doctor or dentist about all||
0565|090|P|the products you use (including prescription drugs,||
0565|091|P|nonprescription drugs, and herbal products).||
0565|092|P|   This medication is not recommended for children because it may||
0565|093|P|affect the bones.||
0565|094|P|   During pregnancy, this medication should be used only when||
0565|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
0565|096|P|   It is unknown if this drug passes into breast milk. Consult||
0565|097|P|your doctor before breastfeeding.||
0565|098|B|||
0565|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0565|100|I|medications work or increase your risk for serious side effects.||
0565|101|I|This document does not contain all possible drug interactions.||
0565|102|I|Keep a list of all the products you use (including||
0565|103|I|prescription/nonprescription drugs and herbal products) and share||
0565|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
0565|105|I|the dosage of any medicines without your doctor's approval.||
0565|106|I|   Lanthanum may stop some medications from working well if you||
0565|107|I|take them at the same time. Ask your pharmacist for details||
0565|108|I|because you may need to separate the times you take lanthanum by||
0565|109|I|at least 2 hours from the times you take the following||
0565|110|I|medications, among others: mycophenolate, thyroid medications||
0565|111|I|(such as levothyroxine), tetracycline antibiotics (such as||
0565|112|I|doxycycline, tetracycline), drugs that interact with antacids.||
0565|113|I|   Other medications (such as quinolone antibiotics including||
0565|114|I|ciprofloxacin/levofloxacin) may require different separation time||
0565|115|I|schedules. Talk with your doctor or pharmacist about how to||
0565|116|I|schedule lanthanum and your other medications.||
0565|117|B|||
0565|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0565|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0565|120|O|poison control center right away. US residents can call||
0565|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0565|122|B|||
0565|123|N|NOTES:  Your doctor may tell you to follow a special diet to help||
0565|124|N|lower your blood phosphate levels. Follow the diet closely.||
0565|125|N|   Do not share this medication with others.||
0565|126|N|   Lab and/or medical tests (such as blood phosphate and calcium||
0565|127|N|levels) should be done while you are taking this medication. Keep||
0565|128|N|all medical and lab appointments. Consult your doctor for more||
0565|129|N|details.||
0565|130|B|||
0565|131|D|MISSED DOSE:  If you miss a dose, skip the missed dose unless you||
0565|132|D|have just eaten. If it is near the time of the next dose, skip||
0565|133|D|the missed dose. Take your next dose at the regular time. Do not||
0565|134|D|double the dose to catch up.||
0565|135|B|||
0565|136|R|STORAGE:  Store at room temperature away from light and moisture.||
0565|137|R|Do not store in the bathroom. Keep all medications away from||
0565|138|R|children and pets.||
0565|139|R|   Do not flush medications down the toilet or pour them into a||
0565|140|R|drain unless instructed to do so. Properly discard this product||
0565|141|R|when it is expired or no longer needed. Consult your pharmacist||
0565|142|R|or local waste disposal company.||
0565|143|B|||
0565|144|A|Information last revised May 2024.||
0565|145|A|Copyright(c) 2025 First Databank, Inc.||
0565|146|B|||
0566|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0566|002|Z|does NOT have all possible information about this product. This||
0566|003|Z|information does not assure that this product is safe, effective,||
0566|004|Z|or appropriate for you. This information is not individual||
0566|005|Z|medical advice and does not substitute for the advice of your||
0566|006|Z|health care professional. Always ask your health care||
0566|007|Z|professional for complete information about this product and your||
0566|008|Z|specific health needs.||
0566|009|B|||
0566|010|T|ALBUTEROL (SALBUTAMOL) LIQUID - ORAL||
0566|011|F|(al-BUE-ter-ol/sal-BUE-ta-mol)||
0566|012|B|||
0566|013|C|COMMON BRAND NAME(S): Proventil||
0566|014|B|||
0566|015|U|USES:  Albuterol (also known as salbutamol) is used to treat||
0566|016|U|wheezing and shortness of breath caused by breathing problems||
0566|017|U|(such as asthma, chronic obstructive pulmonary disease).||
0566|018|U|Albuterol belongs to a class of drugs known as bronchodilators.||
0566|019|U|It works by relaxing the muscles around the airways so that they||
0566|020|U|open up and you can breathe more easily. Controlling symptoms of||
0566|021|U|breathing problems can decrease time lost from work or school.||
0566|022|U|   This medication is taken by mouth and does not work right||
0566|023|U|away. It should not be used for sudden attacks of breathing||
0566|024|U|trouble. Your doctor may prescribe a quick-relief inhaler for||
0566|025|U|sudden shortness of breath/asthma attacks while you are on this||
0566|026|U|medication. Always have the quick-relief inhaler with you.||
0566|027|U|Consult your doctor or pharmacist for more details.||
0566|028|B|||
0566|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
0566|030|H|doctor, usually 3 or 4 times daily. The dosage is based on your||
0566|031|H|medical condition and response to treatment.||
0566|032|H|   Carefully measure your prescribed dose using a||
0566|033|H|medication-measuring device or spoon. Do not use a household||
0566|034|H|spoon because you may not get the correct dose.||
0566|035|H|   Use this medication regularly to get the most benefit from it.||
0566|036|H|To help you remember, take it at the same times each day. Do not||
0566|037|H|increase your dose or take this drug more often than prescribed||
0566|038|H|because your risk of serious side effects will increase.||
0566|039|H|   Learn which of your medications you should use every day and||
0566|040|H|which you should use if your breathing suddenly worsens. Ask your||
0566|041|H|doctor what to do if you have worsening cough or shortness of||
0566|042|H|breath, wheezing, increased sputum, worsening peak flow meter||
0566|043|H|readings, increased use of your quick-relief inhaler, or if your||
0566|044|H|quick-relief inhaler does not seem to be working well. Learn when||
0566|045|H|you can self-medicate and when you should get medical help right||
0566|046|H|away.||
0566|047|B|||
0566|048|S|SIDE EFFECTS:  Nervousness, shaking (tremor), headache, or||
0566|049|S|dizziness may occur. If any of these effects last or get worse,||
0566|050|S|tell your doctor or pharmacist promptly.||
0566|051|S|   Remember that this medication has been prescribed because your||
0566|052|S|doctor has judged that the benefit to you is greater than the||
0566|053|S|risk of side effects. Many people using this medication do not||
0566|054|S|have serious side effects.||
0566|055|S|   This medication may raise your blood pressure. Check your||
0566|056|S|blood pressure regularly and tell your doctor if the results are||
0566|057|S|high.||
0566|058|S|   Tell your doctor right away if you have any serious side||
0566|059|S|effects, including: fast/pounding heartbeat.||
0566|060|S|   Get medical help right away if you have any very serious side||
0566|061|S|effects, including: chest pain, irregular heartbeat.||
0566|062|S|   Rarely, this medication has caused severe (rarely fatal),||
0566|063|S|sudden worsening of breathing problems/asthma (paradoxical||
0566|064|S|bronchospasm). If you experience sudden wheezing, get medical||
0566|065|S|help right away.||
0566|066|S|   A very serious allergic reaction to this drug is rare.||
0566|067|S|However, get medical help right away if you notice any symptoms||
0566|068|S|of a serious allergic reaction, including: rash, itching/swelling||
0566|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0566|070|S|breathing.||
0566|071|S|   This is not a complete list of possible side effects. If you||
0566|072|S|notice other effects not listed above, contact your doctor or||
0566|073|S|pharmacist.||
0566|074|S|   In the US -||
0566|075|S|   Call your doctor for medical advice about side effects. You||
0566|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0566|077|S|www.fda.gov/medwatch.||
0566|078|S|   In Canada - Call your doctor for medical advice about side||
0566|079|S|effects. You may report side effects to Health Canada at||
0566|080|S|1-866-234-2345.||
0566|081|B|||
0566|082|P|PRECAUTIONS:  Before taking albuterol, tell your doctor or||
0566|083|P|pharmacist if you are allergic to it; or if you have had a||
0566|084|P|serious reaction to similar drugs (such as levalbuterol,||
0566|085|P|metaproterenol, terbutaline); or if you have any other allergies.||
0566|086|P|This product may contain inactive ingredients, which can cause||
0566|087|P|allergic reactions or other problems. Talk to your pharmacist for||
0566|088|P|more details.||
0566|089|P|   Before using this medication, tell your doctor or pharmacist||
0566|090|P|your medical history, especially of: heart problems (such as||
0566|091|P|irregular heartbeat, angina, heart attack), high blood pressure,||
0566|092|P|diabetes, seizure.||
0566|093|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0566|094|P|can make you more dizzy. Do not drive, use machinery, or do||
0566|095|P|anything that needs alertness until you can do it safely. Limit||
0566|096|P|alcoholic beverages. Talk to your doctor if you are using||
0566|097|P|marijuana (cannabis).||
0566|098|P|   Before having surgery, tell your doctor or dentist about all||
0566|099|P|the products you use (including prescription drugs,||
0566|100|P|nonprescription drugs, and herbal products).||
0566|101|P|   During pregnancy, this medication should be used only when||
0566|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0566|103|P|   It is unknown if this medication passes into breast milk.||
0566|104|P|Consult your doctor before breastfeeding.||
0566|105|B|||
0566|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0566|107|I|medications work or increase your risk for serious side effects.||
0566|108|I|This document does not contain all possible drug interactions.||
0566|109|I|Keep a list of all the products you use (including||
0566|110|I|prescription/nonprescription drugs and herbal products) and share||
0566|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0566|112|I|the dosage of any medicines without your doctor's approval.||
0566|113|B|||
0566|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0566|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0566|116|O|poison control center right away. US residents can call||
0566|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0566|118|O|Symptoms of overdose may include: fast/pounding/irregular||
0566|119|O|heartbeat, severe shaking (tremors), seizures, chest pain.||
0566|120|B|||
0566|121|N|NOTES:  Do not share this medication with others.||
0566|122|N|   Lab and/or medical tests (such as lung function, blood||
0566|123|N|pressure) should be done while you are taking this medication.||
0566|124|N|Keep all medical and lab appointments. Consult your doctor for||
0566|125|N|more details.||
0566|126|N|   Avoid allergens/irritants such as smoke, pollen, pet dander,||
0566|127|N|dust, or molds that may worsen breathing problems.||
0566|128|N|   Learn to use a peak flow meter, use it daily, and promptly||
0566|129|N|report worsening breathing problems (such as readings in the||
0566|130|N|yellow/red range, increased use of quick-relief inhalers).||
0566|131|N|   Ask your doctor or pharmacist whether you should have an||
0566|132|N|annual flu shot.||
0566|133|B|||
0566|134|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0566|135|D|remember. If it is near the time of the next dose, skip the||
0566|136|D|missed dose. Take your next dose at the regular time. Do not||
0566|137|D|double the dose to catch up.||
0566|138|B|||
0566|139|R|STORAGE:  Store at room temperature. Keep all medications away||
0566|140|R|from children and pets.||
0566|141|R|   Do not flush medications down the toilet or pour them into a||
0566|142|R|drain unless instructed to do so. Properly discard this product||
0566|143|R|when it is expired or no longer needed. Consult your pharmacist||
0566|144|R|or local waste disposal company.||
0566|145|B|||
0566|146|M|MEDICAL ALERT:  Your condition can cause complications in a||
0566|147|M|medical emergency. For information about enrolling in MedicAlert,||
0566|148|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0566|149|B|||
0566|150|A|Information last revised October 2024.||
0566|151|A|Copyright(c) 2025 First Databank, Inc.||
0566|152|B|||
0569|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0569|002|Z|does NOT have all possible information about this product. This||
0569|003|Z|information does not assure that this product is safe, effective,||
0569|004|Z|or appropriate for you. This information is not individual||
0569|005|Z|medical advice and does not substitute for the advice of your||
0569|006|Z|health care professional. Always ask your health care||
0569|007|Z|professional for complete information about this product and your||
0569|008|Z|specific health needs.||
0569|009|B|||
0569|010|T|ALBUTEROL (SALBUTAMOL) EXTENDED-RELEASE TABLET - ORAL||
0569|011|F|(al-BUE-ter-ol/sal-BUE-ta-mol)||
0569|012|B|||
0569|013|C|COMMON BRAND NAME(S): Vospire ER||
0569|014|B|||
0569|015|U|USES:  Albuterol (also known as salbutamol) is used to treat||
0569|016|U|wheezing and shortness of breath caused by breathing problems||
0569|017|U|(such as asthma, chronic obstructive pulmonary disease).||
0569|018|U|Albuterol belongs to a class of drugs known as bronchodilators.||
0569|019|U|It works by relaxing the muscles around the airways so that they||
0569|020|U|open up and you can breathe more easily. Controlling symptoms of||
0569|021|U|breathing problems can decrease time lost from work or school.||
0569|022|B|||
0569|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
0569|024|H|doctor, usually twice a day (12 hours apart). Swallow the tablets||
0569|025|H|whole. Do not crush or chew the tablets. Doing so can release all||
0569|026|H|of the drug at once, increasing the risk of side effects.||
0569|027|H|   The dosage is based on your medical condition and response to||
0569|028|H|treatment. Do not increase your dose or take this drug more often||
0569|029|H|than prescribed because your risk of serious side effects will||
0569|030|H|increase.||
0569|031|H|   Use this medication regularly to get the most benefit from it.||
0569|032|H|To help you remember, take it at the same times each day.||
0569|033|H|   This medication does not work right away and should not be||
0569|034|H|used for sudden attacks of breathing trouble. Your doctor may||
0569|035|H|prescribe a quick-relief inhaler for sudden shortness of||
0569|036|H|breath/asthma attacks while you are taking this medication.||
0569|037|H|Consult your doctor or pharmacist for more details.||
0569|038|H|   If you use other asthma drugs (including inhaled medications),||
0569|039|H|ask your doctor about how to properly take this medication with||
0569|040|H|your other asthma medicines.||
0569|041|H|   If this medication stops working well or your breathing||
0569|042|H|symptoms become worse, get medical help right away.||
0569|043|B|||
0569|044|S|SIDE EFFECTS:  Nervousness, shaking (tremor), headache, trouble||
0569|045|S|sleeping, dizziness, or nausea may occur. If any of these effects||
0569|046|S|last or get worse, tell your doctor or pharmacist promptly.||
0569|047|S|   Remember that this medication has been prescribed because your||
0569|048|S|doctor has judged that the benefit to you is greater than the||
0569|049|S|risk of side effects. Many people using this medication do not||
0569|050|S|have serious side effects.||
0569|051|S|   This medication may raise your blood pressure. Check your||
0569|052|S|blood pressure regularly and tell your doctor if the results are||
0569|053|S|high.||
0569|054|S|   Tell your doctor right away if you have any serious side||
0569|055|S|effects, including: fast/pounding heartbeat.||
0569|056|S|   Get medical help right away if you have any very serious side||
0569|057|S|effects, including: chest pain, irregular heartbeat.||
0569|058|S|   Rarely, this medication has caused severe (rarely fatal),||
0569|059|S|sudden worsening of breathing problems/asthma (paradoxical||
0569|060|S|bronchospasm). If you experience sudden wheezing, get medical||
0569|061|S|help right away.||
0569|062|S|   A very serious allergic reaction to this drug is rare.||
0569|063|S|However, get medical help right away if you notice any symptoms||
0569|064|S|of a serious allergic reaction, including: rash, itching/swelling||
0569|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0569|066|S|breathing.||
0569|067|S|   This is not a complete list of possible side effects. If you||
0569|068|S|notice other effects not listed above, contact your doctor or||
0569|069|S|pharmacist.||
0569|070|S|   In the US -||
0569|071|S|   Call your doctor for medical advice about side effects. You||
0569|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0569|073|S|www.fda.gov/medwatch.||
0569|074|S|   In Canada - Call your doctor for medical advice about side||
0569|075|S|effects. You may report side effects to Health Canada at||
0569|076|S|1-866-234-2345.||
0569|077|B|||
0569|078|P|PRECAUTIONS:  Before taking albuterol, tell your doctor or||
0569|079|P|pharmacist if you are allergic to it; or if you have had a||
0569|080|P|serious reaction to similar drugs (such as levalbuterol,||
0569|081|P|metaproterenol, terbutaline); or if you have any other allergies.||
0569|082|P|This product may contain inactive ingredients, which can cause||
0569|083|P|allergic reactions or other problems. Talk to your pharmacist for||
0569|084|P|more details.||
0569|085|P|   Before using this medication, tell your doctor or pharmacist||
0569|086|P|your medical history, especially of: heart problems (such as||
0569|087|P|irregular heartbeat, angina, heart attack), high blood pressure,||
0569|088|P|diabetes, low levels of potassium in the blood, seizure.||
0569|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0569|090|P|can make you more dizzy. Do not drive, use machinery, or do||
0569|091|P|anything that needs alertness until you can do it safely. Limit||
0569|092|P|alcoholic beverages. Talk to your doctor if you are using||
0569|093|P|marijuana (cannabis).||
0569|094|P|   Before having surgery, tell your doctor or dentist about all||
0569|095|P|the products you use (including prescription drugs,||
0569|096|P|nonprescription drugs, and herbal products).||
0569|097|P|   Older adults may be more sensitive to the side effects of this||
0569|098|P|drug, especially the effects on the heart.||
0569|099|P|   During pregnancy, this medication should be used only when||
0569|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0569|101|P|   It is unknown if this drug passes into breast milk. Consult||
0569|102|P|your doctor before breastfeeding.||
0569|103|B|||
0569|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0569|105|I|medications work or increase your risk for serious side effects.||
0569|106|I|This document does not contain all possible drug interactions.||
0569|107|I|Keep a list of all the products you use (including||
0569|108|I|prescription/nonprescription drugs and herbal products) and share||
0569|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
0569|110|I|the dosage of any medicines without your doctor's approval.||
0569|111|B|||
0569|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0569|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0569|114|O|poison control center right away. US residents can call||
0569|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0569|116|O|Symptoms of overdose may include: fast/pounding/irregular||
0569|117|O|heartbeat, severe shaking (tremors), seizures.||
0569|118|B|||
0569|119|N|NOTES:  Do not share this medication with others.||
0569|120|N|   Lab and/or medical tests (such as lung function, blood||
0569|121|N|pressure, levels of potassium in the blood) may be done while you||
0569|122|N|are taking this medication. Keep all medical and lab||
0569|123|N|appointments. Consult your doctor for more details.||
0569|124|N|   Avoid allergens/irritants such as smoke, pollen, pet dander,||
0569|125|N|dust, or molds that may worsen breathing problems.||
0569|126|N|   Learn to use a peak flow meter, use it daily, and promptly||
0569|127|N|report worsening breathing problems (such as readings in the||
0569|128|N|yellow/red range, increased use of quick-relief inhalers).||
0569|129|N|   Ask your doctor or pharmacist whether you should have an||
0569|130|N|annual flu shot.||
0569|131|B|||
0569|132|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0569|133|D|remember. If it is near the time of the next dose, skip the||
0569|134|D|missed dose. Take your next dose at the regular time. Do not||
0569|135|D|double the dose to catch up.||
0569|136|B|||
0569|137|R|STORAGE:  Store at room temperature away from light and moisture.||
0569|138|R|Do not store in the bathroom. Keep all medications away from||
0569|139|R|children and pets.||
0569|140|R|   Do not flush medications down the toilet or pour them into a||
0569|141|R|drain unless instructed to do so. Properly discard this product||
0569|142|R|when it is expired or no longer needed. Consult your pharmacist||
0569|143|R|or local waste disposal company.||
0569|144|B|||
0569|145|M|MEDICAL ALERT:  Your condition can cause complications in a||
0569|146|M|medical emergency. For information about enrolling in MedicAlert,||
0569|147|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0569|148|B|||
0569|149|A|Information last revised May 2024.||
0569|150|A|Copyright(c) 2025 First Databank, Inc.||
0569|151|B|||
0570|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0570|002|Z|does NOT have all possible information about this product. This||
0570|003|Z|information does not assure that this product is safe, effective,||
0570|004|Z|or appropriate for you. This information is not individual||
0570|005|Z|medical advice and does not substitute for the advice of your||
0570|006|Z|health care professional. Always ask your health care||
0570|007|Z|professional for complete information about this product and your||
0570|008|Z|specific health needs.||
0570|009|B|||
0570|010|T|INDOMETHACIN SUSTAINED-RELEASE CAPSULE - ORAL||
0570|011|F|(in-doh-METH-uh-sin)||
0570|012|B|||
0570|013|C|COMMON BRAND NAME(S): Indocin SR||
0570|014|B|||
0570|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0570|016|W|indomethacin) may rarely increase the risk for a heart attack or||
0570|017|W|stroke. This effect can happen at any time while taking this drug||
0570|018|W|but is more likely if you take it for a long time. The risk may||
0570|019|W|be greater in older adults or if you have heart disease or||
0570|020|W|increased risk for heart disease (for example, due to smoking,||
0570|021|W|family history of heart disease, or conditions such as high blood||
0570|022|W|pressure or diabetes). Do not take this drug right before or||
0570|023|W|after heart bypass surgery (CABG).||
0570|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0570|025|W|bleeding from the stomach or intestines. This effect can occur||
0570|026|W|without warning symptoms at any time while taking this drug.||
0570|027|W|Older adults may be at higher risk for this effect. (See also||
0570|028|W|Precautions and Drug Interactions sections.)||
0570|029|W|   Stop taking indomethacin and get medical help right away if||
0570|030|W|you notice any of the following rare but serious side effects:||
0570|031|W|stomach/abdominal pain that doesn't go away, bloody or||
0570|032|W|black/tarry stools, vomit that looks like coffee grounds,||
0570|033|W|chest/jaw/left arm pain, shortness of breath, unusual sweating,||
0570|034|W|weakness on one side of the body, sudden vision changes, trouble||
0570|035|W|speaking.||
0570|036|W|   Talk with your doctor or pharmacist about the risks and||
0570|037|W|benefits of treatment with this medication.||
0570|038|B|||
0570|039|U|USES:  Indomethacin is used to relieve pain, swelling, and joint||
0570|040|U|stiffness caused by arthritis, bursitis, and tendonitis. Reducing||
0570|041|U|these symptoms helps you do more of your normal daily activities.||
0570|042|U|The sustained release capsule does not relieve pain quickly. Do||
0570|043|U|not use it for sudden gout attacks. This medication is known as a||
0570|044|U|nonsteroidal anti-inflammatory drug (NSAID).||
0570|045|U|   If you are treating a chronic condition such as arthritis, ask||
0570|046|U|your doctor about non-drug treatments and/or using other||
0570|047|U|medications to treat your pain. See also Warning section.||
0570|048|B|||
0570|049|V|OTHER USES:  This section contains uses of this drug that are not||
0570|050|V|listed in the approved professional labeling for the drug but||
0570|051|V|that may be prescribed by your health care professional. Use this||
0570|052|V|drug for a condition that is listed in this section only if it||
0570|053|V|has been so prescribed by your health care professional.||
0570|054|V|   This medication may also be used to relieve pain caused by||
0570|055|V|inflammation of the pouch surrounding the heart and other||
0570|056|V|conditions, as prescribed by your doctor.||
0570|057|B|||
0570|058|H|HOW TO USE:  Read the Medication Guide provided by your||
0570|059|H|pharmacist before you start using indomethacin and each time you||
0570|060|H|get a refill. If you have any questions, ask your doctor or||
0570|061|H|pharmacist.||
0570|062|H|   Swallow this medication whole. Do not crush or chew the||
0570|063|H|capsules. Doing so can destroy the long action of the drug and||
0570|064|H|may increase side effects.||
0570|065|H|   Take this medication by mouth as directed by your doctor,||
0570|066|H|usually once or twice daily with a full glass of water (8 ounces||
0570|067|H|or 240 milliliters). Do not lie down for at least 10 minutes||
0570|068|H|after taking this drug. Take this medication either with food,||
0570|069|H|right after meals, or with antacids to prevent stomach upset.||
0570|070|H|   The dosage is based on your medical condition and response to||
0570|071|H|treatment. To lessen side effect risks (such as stomach||
0570|072|H|bleeding), use this medication at the lowest effective dose for||
0570|073|H|the shortest possible length of time. Do not increase your dose||
0570|074|H|or take it more often than prescribed. For chronic conditions||
0570|075|H|such as arthritis, keep taking it as directed by your doctor.||
0570|076|H|Discuss the risks and benefits with your doctor or pharmacist.||
0570|077|H|   In certain conditions (such as arthritis), it may take up to 4||
0570|078|H|weeks when this drug is taken regularly before you notice the||
0570|079|H|full benefits.||
0570|080|H|   Tell your doctor if your condition gets worse.||
0570|081|B|||
0570|082|S|SIDE EFFECTS:  See also Warning section.||
0570|083|S|   Upset stomach, heartburn, headache, drowsiness, or dizziness||
0570|084|S|may occur. If any of these effects last or get worse, tell your||
0570|085|S|doctor or pharmacist promptly.||
0570|086|S|   Remember that this medication has been prescribed because your||
0570|087|S|doctor has judged that the benefit to you is greater than the||
0570|088|S|risk of side effects. Many people using this medication do not||
0570|089|S|have serious side effects.||
0570|090|S|   This medication may raise your blood pressure. Check your||
0570|091|S|blood pressure regularly and tell your doctor if the results are||
0570|092|S|high.||
0570|093|S|   Tell your doctor right away if you have any serious side||
0570|094|S|effects, including: hearing changes (such as ringing in the||
0570|095|S|ears), mental/mood changes (such as confusion, hallucinations),||
0570|096|S|difficult/painful swallowing, signs of kidney problems (such as||
0570|097|S|change in the amount of urine), symptoms of heart failure (such||
0570|098|S|as swelling ankles/feet, unusual tiredness, unusual/sudden weight||
0570|099|S|gain).||
0570|100|S|   This drug may rarely cause serious (possibly fatal) liver||
0570|101|S|disease. Get medical help right away if you have any symptoms of||
0570|102|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0570|103|S|of appetite, dark urine, severe stomach/abdominal pain, yellowing||
0570|104|S|eyes/skin.||
0570|105|S|   A very serious allergic reaction to this drug is rare.||
0570|106|S|However, get medical help right away if you notice any symptoms||
0570|107|S|of a serious allergic reaction, including: fever, swollen lymph||
0570|108|S|nodes, rash, itching/swelling (especially of the||
0570|109|S|face/tongue/throat), severe dizziness, trouble breathing.||
0570|110|S|   This is not a complete list of possible side effects. If you||
0570|111|S|notice other effects not listed above, contact your doctor or||
0570|112|S|pharmacist.||
0570|113|S|   In the US -||
0570|114|S|   Call your doctor for medical advice about side effects. You||
0570|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0570|116|S|www.fda.gov/medwatch.||
0570|117|S|   In Canada - Call your doctor for medical advice about side||
0570|118|S|effects. You may report side effects to Health Canada at||
0570|119|S|1-866-234-2345.||
0570|120|B|||
0570|121|P|PRECAUTIONS:  Before taking indomethacin, tell your doctor or||
0570|122|P|pharmacist if you are allergic to it; or to aspirin or other||
0570|123|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
0570|124|P|any other allergies. This product may contain inactive||
0570|125|P|ingredients, which can cause allergic reactions or other||
0570|126|P|problems. Talk to your pharmacist for more details.||
0570|127|P|   Before using this medication, tell your doctor or pharmacist||
0570|128|P|your medical history, especially of: asthma (including a history||
0570|129|P|of worsening breathing after taking aspirin or other NSAIDs),||
0570|130|P|bleeding or clotting problems, growths in the nose (nasal||
0570|131|P|polyps), heart disease (such as previous heart attack), high||
0570|132|P|blood pressure, liver disease, stomach/intestinal/esophagus||
0570|133|P|problems (such as bleeding, ulcers, recurring heartburn), stroke.||
0570|134|P|   Kidney problems can sometimes occur with the use of NSAID||
0570|135|P|medications, including indomethacin. Problems are more likely to||
0570|136|P|occur if you are dehydrated, have heart failure or kidney||
0570|137|P|disease, are an older adult, or if you take certain medications||
0570|138|P|(see also Drug Interactions section). Drink plenty of fluids as||
0570|139|P|directed by your doctor to prevent dehydration and tell your||
0570|140|P|doctor right away if you have a change in the amount of urine.||
0570|141|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0570|142|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0570|143|P|machinery, or do anything that needs alertness until you can do||
0570|144|P|it safely. Talk to your doctor if you are using marijuana||
0570|145|P|(cannabis).||
0570|146|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0570|147|P|and tobacco, especially when combined with this medicine, may||
0570|148|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0570|149|P|smoking. Consult your doctor or pharmacist for more information.||
0570|150|P|   Before having surgery, tell your doctor or dentist about all||
0570|151|P|the products you use (including prescription drugs,||
0570|152|P|nonprescription drugs, and herbal products).||
0570|153|P|   This medication may make you more sensitive to the sun. Limit||
0570|154|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0570|155|P|sunscreen and wear protective clothing when outdoors. Tell your||
0570|156|P|doctor right away if you get sunburned or have skin||
0570|157|P|blisters/redness.||
0570|158|P|   Older adults may be at greater risk for stomach/intestinal||
0570|159|P|bleeding, kidney problems, heart attack, stroke, and mental/mood||
0570|160|P|changes while using this drug.||
0570|161|P|   Children may be more sensitive to the side effects of this||
0570|162|P|drug, especially serious liver problems. Caution is advised when||
0570|163|P|this drug is used by children. Discuss the risks and benefits of||
0570|164|P|treatment with your doctor.||
0570|165|P|   Before using this medication, women of childbearing age should||
0570|166|P|talk with their doctor(s) about the benefits and risks. Tell your||
0570|167|P|doctor if you are pregnant or if you plan to become pregnant.||
0570|168|P|This medication may harm an unborn baby and cause problems with||
0570|169|P|normal labor/delivery. It is not recommended for use in pregnancy||
0570|170|P|from 20 weeks until delivery. If your doctor decides that you||
0570|171|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0570|172|P|you should use the lowest effective dose for the shortest||
0570|173|P|possible time. You should not use this medication after 30 weeks||
0570|174|P|of pregnancy.||
0570|175|P|   This drug passes into breast milk and may have undesirable||
0570|176|P|effects on a nursing infant. Consult your doctor before||
0570|177|P|breastfeeding.||
0570|178|B|||
0570|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0570|180|I|medications work or increase your risk for serious side effects.||
0570|181|I|This document does not contain all possible drug interactions.||
0570|182|I|Keep a list of all the products you use (including||
0570|183|I|prescription/nonprescription drugs and herbal products) and share||
0570|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
0570|185|I|the dosage of any medicines without your doctor's approval.||
0570|186|I|   Some products that may interact with this drug include:||
0570|187|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
0570|188|I|angiotensin II receptor blockers (such as losartan, valsartan),||
0570|189|I|cidofovir, lithium, methotrexate, corticosteroids (such as||
0570|190|I|prednisone), "water pills" (diuretics such as furosemide).||
0570|191|I|   This medication may increase the risk of bleeding when taken||
0570|192|I|with other drugs that also may cause bleeding. Examples include||
0570|193|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0570|194|I|dabigatran/enoxaparin/warfarin, among others.||
0570|195|I|   Check all prescription and nonprescription medicine labels||
0570|196|I|carefully since many medications contain pain relievers/fever||
0570|197|I|reducers (aspirin, NSAIDs such as celecoxib, diflunisal,||
0570|198|I|ibuprofen, or ketorolac). These drugs are similar to indomethacin||
0570|199|I|and may increase your risk of side effects if taken together.||
0570|200|I|However, if your doctor has told you to take low-dose aspirin to||
0570|201|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0570|202|I|you should keep taking the aspirin unless your doctor tells you||
0570|203|I|not to. Ask your doctor or pharmacist for more details.||
0570|204|I|   This medication may interfere with certain lab tests, possibly||
0570|205|I|causing false test results. Make sure lab personnel and all your||
0570|206|I|doctors know you use this drug.||
0570|207|B|||
0570|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0570|209|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0570|210|O|poison control center right away. US residents can call||
0570|211|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0570|212|O|Symptoms of overdose may include: severe stomach pain, vomit that||
0570|213|O|looks like coffee grounds, extreme drowsiness, slow or shallow||
0570|214|O|breathing, confusion, seizures.||
0570|215|B|||
0570|216|N|NOTES:  Do not share this medication with others.||
0570|217|N|   Lab and/or medical tests (such as blood pressure, complete||
0570|218|N|blood count, liver/kidney function) may be done while you are||
0570|219|N|taking this medication. Keep all medical and lab appointments.||
0570|220|N|Consult your doctor for more details.||
0570|221|N|   Non-drug treatment for arthritis that is approved by your||
0570|222|N|doctor (such as weight loss if needed, strengthening and||
0570|223|N|conditioning exercises) may help improve your flexibility, range||
0570|224|N|of motion, and joint function. Consult your doctor for specific||
0570|225|N|instructions.||
0570|226|B|||
0570|227|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0570|228|D|If it is near the time of the next dose, skip the missed dose.||
0570|229|D|Use your next dose at the regular time. Do not double the dose to||
0570|230|D|catch up.||
0570|231|B|||
0570|232|R|STORAGE:  Store at room temperature away from light and moisture.||
0570|233|R|Do not store in the bathroom. Keep all medications away from||
0570|234|R|children and pets.||
0570|235|R|   Do not flush medications down the toilet or pour them into a||
0570|236|R|drain unless instructed to do so. Properly discard this product||
0570|237|R|when it is expired or no longer needed. Consult your pharmacist||
0570|238|R|or local waste disposal company.||
0570|239|B|||
0570|240|A|Information last revised May 2025.||
0570|241|A|Copyright(c) 2025 First Databank, Inc.||
0570|242|B|||
0572|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0572|002|Z|does NOT have all possible information about this product. This||
0572|003|Z|information does not assure that this product is safe, effective,||
0572|004|Z|or appropriate for you. This information is not individual||
0572|005|Z|medical advice and does not substitute for the advice of your||
0572|006|Z|health care professional. Always ask your health care||
0572|007|Z|professional for complete information about this product and your||
0572|008|Z|specific health needs.||
0572|009|B|||
0572|010|T|TERBUTALINE - ORAL||
0572|011|F|(ter-BYOO-ta-leen)||
0572|012|B|||
0572|013|C|COMMON BRAND NAME(S): Brethine||
0572|014|B|||
0572|015|W|WARNING:  Terbutaline should not be used to prevent or treat||
0572|016|W|early labor, since it has risks to the mother that are greater||
0572|017|W|than the benefits. Serious (sometimes fatal) side effects have||
0572|018|W|rarely occurred in mothers taking terbutaline during labor, such||
0572|019|W|as chest pain, fast/irregular heartbeats, and trouble breathing.||
0572|020|W|If you are pregnant or become pregnant and are taking terbutaline||
0572|021|W|for another medical condition (such as asthma), talk to your||
0572|022|W|doctor or pharmacist about whether terbutaline is still right for||
0572|023|W|you.||
0572|024|B|||
0572|025|U|USES:  Terbutaline is used to treat wheezing and shortness of||
0572|026|U|breath from lung problems (such as asthma, chronic obstructive||
0572|027|U|pulmonary disease, bronchitis and emphysema). Controlling these||
0572|028|U|symptoms can decrease time lost from work or school. Terbutaline||
0572|029|U|belongs to a class of drugs known as bronchodilators. It works by||
0572|030|U|relaxing the muscles around the airways so that they open up and||
0572|031|U|you can breathe more easily.||
0572|032|B|||
0572|033|H|HOW TO USE:  Take this medication by mouth with or without food||
0572|034|H|as directed by your doctor, usually 3 times daily. The dosage is||
0572|035|H|based on your medical condition and response to treatment.||
0572|036|H|   Take this medication exactly as prescribed. Do not take more||
0572|037|H|of this medication or take it more often than recommended by your||
0572|038|H|doctor. If you have been directed to use this medication on a||
0572|039|H|daily schedule, use it regularly at the same times each day in||
0572|040|H|order to get the most benefit from it.||
0572|041|H|   If you take other asthma drugs by mouth or inhaling devices,||
0572|042|H|ask your doctor about how to correctly take this medication with||
0572|043|H|your other asthma medicines.||
0572|044|H|   If you notice less effect than usual from this medication, if||
0572|045|H|your symptoms get worse, or if you feel you need to take any of||
0572|046|H|your asthma medications more often than recommended, get medical||
0572|047|H|help right away.||
0572|048|B|||
0572|049|S|SIDE EFFECTS:  Nervousness, shaking (tremor), dizziness,||
0572|050|S|drowsiness or headache may occur. If any of these effects last or||
0572|051|S|get worse, notify your doctor or pharmacist promptly.||
0572|052|S|   Remember that this medication has been prescribed because your||
0572|053|S|doctor has judged that the benefit to you is greater than the||
0572|054|S|risk of side effects. Many people using this medication do not||
0572|055|S|have serious side effects.||
0572|056|S|   This medication may raise your blood pressure. Check your||
0572|057|S|blood pressure regularly and tell your doctor if the results are||
0572|058|S|high.||
0572|059|S|   Tell your doctor right away if you have any serious side||
0572|060|S|effects, including: fast/pounding/irregular heartbeat, chest||
0572|061|S|pain, muscle cramps, weakness, seizures.||
0572|062|S|   Rarely, this medication has caused severe (rarely fatal),||
0572|063|S|sudden worsening of breathing problems/asthma (paradoxical||
0572|064|S|bronchospasm). If you experience sudden wheezing, get medical||
0572|065|S|help right away.||
0572|066|S|   A very serious allergic reaction to this drug is rare.||
0572|067|S|However, get medical help right away if you notice any symptoms||
0572|068|S|of a serious allergic reaction, including: rash, itching/swelling||
0572|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0572|070|S|breathing.||
0572|071|S|   This is not a complete list of possible side effects. If you||
0572|072|S|notice other effects not listed above, contact your doctor or||
0572|073|S|pharmacist. See Warning Section.||
0572|074|S|   In the US -||
0572|075|S|   Call your doctor for medical advice about side effects. You||
0572|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0572|077|S|www.fda.gov/medwatch.||
0572|078|S|   In Canada - Call your doctor for medical advice about side||
0572|079|S|effects. You may report side effects to Health Canada at||
0572|080|S|1-866-234-2345.||
0572|081|B|||
0572|082|P|PRECAUTIONS:  Before taking terbutaline, tell your doctor or||
0572|083|P|pharmacist if you are allergic to it; or to similar||
0572|084|P|bronchodilators (such as albuterol, metaproterenol, salmeterol);||
0572|085|P|or to sympathomimetic drugs (such as epinephrine,||
0572|086|P|pseudoephedrine); or if you have any other allergies. This||
0572|087|P|product may contain inactive ingredients, which can cause||
0572|088|P|allergic reactions or other problems. Talk to your pharmacist for||
0572|089|P|more details.||
0572|090|P|   Before using this medication, tell your doctor or pharmacist||
0572|091|P|your medical history, especially of: heart disease (such as||
0572|092|P|irregular heartbeat, ischemic heart disease), high blood||
0572|093|P|pressure, seizures, overactive thyroid (hyperthyroidism),||
0572|094|P|diabetes, low blood potassium level (hypokalemia).||
0572|095|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0572|096|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0572|097|P|machinery, or do anything that needs alertness until you can do||
0572|098|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0572|099|P|are using marijuana (cannabis).||
0572|100|P|   Before having surgery, tell your doctor or dentist about all||
0572|101|P|the products you use (including prescription drugs,||
0572|102|P|nonprescription drugs, and herbal products).||
0572|103|P|   Older adults may be more sensitive to the side effects of this||
0572|104|P|drug, especially the effects on the heart.||
0572|105|P|   During pregnancy, this medication should be used only when||
0572|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
0572|107|P|See Warning Section.||
0572|108|P|   Terbutaline passes into breast milk. Consult your doctor||
0572|109|P|before breastfeeding.||
0572|110|B|||
0572|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0572|112|I|medications work or increase your risk for serious side effects.||
0572|113|I|This document does not contain all possible drug interactions.||
0572|114|I|Keep a list of all the products you use (including||
0572|115|I|prescription/nonprescription drugs and herbal products) and share||
0572|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
0572|117|I|the dosage of any medicines without your doctor's approval.||
0572|118|B|||
0572|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0572|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0572|121|O|poison control center right away. US residents can call||
0572|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0572|123|O|Symptoms of overdose may include: unusual dizziness, dry mouth,||
0572|124|O|severe headache, seizures, very fast heartbeat, severe nausea.||
0572|125|B|||
0572|126|N|NOTES:  Do not share this medication with others.||
0572|127|N|   Lab and/or medical tests may be done while you are taking this||
0572|128|N|medication. Keep all medical and lab appointments. Consult your||
0572|129|N|doctor for more details.||
0572|130|N|   Avoid allergens, irritants, smoking and other factors that||
0572|131|N|make asthma worse.||
0572|132|N|   Learn to use a peak flow meter, use it daily, and promptly||
0572|133|N|report worsening asthma (such as readings in the yellow/red range||
0572|134|N|or increased use of quick-relief inhalers).||
0572|135|N|   Have your blood pressure and pulse checked regularly while||
0572|136|N|taking this medication. It may be best to learn how to monitor||
0572|137|N|your own blood pressure and pulse. Discuss this with your doctor.||
0572|138|B|||
0572|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0572|140|D|remember. If it is near the time of the next dose, skip the||
0572|141|D|missed dose. Take your next dose at the regular time. Do not||
0572|142|D|double the dose to catch up.||
0572|143|B|||
0572|144|R|STORAGE:  Store at room temperature away from light and moisture.||
0572|145|R|Do not store in the bathroom. Keep all medications away from||
0572|146|R|children and pets.||
0572|147|R|   Do not flush medications down the toilet or pour them into a||
0572|148|R|drain unless instructed to do so. Properly discard this product||
0572|149|R|when it is expired or no longer needed. Consult your pharmacist||
0572|150|R|or local waste disposal company.||
0572|151|B|||
0572|152|M|MEDICAL ALERT:  Your condition can cause complications in a||
0572|153|M|medical emergency. For information about enrolling in MedicAlert,||
0572|154|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0572|155|B|||
0572|156|A|Information last revised May 2024.||
0572|157|A|Copyright(c) 2025 First Databank, Inc.||
0572|158|B|||
0573|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0573|002|Z|does NOT have all possible information about this product. This||
0573|003|Z|information does not assure that this product is safe, effective,||
0573|004|Z|or appropriate for you. This information is not individual||
0573|005|Z|medical advice and does not substitute for the advice of your||
0573|006|Z|health care professional. Always ask your health care||
0573|007|Z|professional for complete information about this product and your||
0573|008|Z|specific health needs.||
0573|009|B|||
0573|010|T|IMIPRAMINE PAMOATE - ORAL||
0573|011|F|(ih-MIH-pra-meen pam-OH-ate)||
0573|012|B|||
0573|013|C|COMMON BRAND NAME(S): Tofranil-PM||
0573|014|B|||
0573|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0573|016|W|of conditions, including depression and other mental/mood||
0573|017|W|disorders. These medications can help prevent suicidal||
0573|018|W|thoughts/attempts and provide other important benefits. However,||
0573|019|W|studies have shown that a small number of people (especially||
0573|020|W|people younger than 25) who take antidepressants for any||
0573|021|W|condition may experience worsening depression, other mental/mood||
0573|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0573|023|W|talk with the doctor about the risks and benefits of||
0573|024|W|antidepressant medication (especially for people younger than||
0573|025|W|25), even if treatment is not for a mental/mood condition.||
0573|026|W|   Tell the doctor right away if you notice worsening||
0573|027|W|depression/other psychiatric conditions, unusual behavior changes||
0573|028|W|(including possible suicidal thoughts/attempts), or other||
0573|029|W|mental/mood changes (including new/worsening anxiety, panic||
0573|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0573|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0573|032|W|especially watchful for these symptoms when a new antidepressant||
0573|033|W|is started or when the dose is changed.||
0573|034|B|||
0573|035|U|USES:  This medication is used to treat depression. Imipramine||
0573|036|U|pamoate belongs to a class of drugs known as tricyclic||
0573|037|U|antidepressants. It works by helping to restore the balance of||
0573|038|U|certain natural substances in the brain.||
0573|039|B|||
0573|040|V|OTHER USES:  This section contains uses of this drug that are not||
0573|041|V|listed in the approved professional labeling for the drug but||
0573|042|V|that may be prescribed by your health care professional. Use this||
0573|043|V|drug for a condition that is listed in this section only if it||
0573|044|V|has been so prescribed by your health care professional.||
0573|045|V|   This drug may also be used for anxiety and panic disorders.||
0573|046|B|||
0573|047|H|HOW TO USE:  Read the Medication Guide provided by your||
0573|048|H|pharmacist before you start taking imipramine and each time you||
0573|049|H|get a refill. If you have any questions, ask your doctor or||
0573|050|H|pharmacist.||
0573|051|H|   Take this medication by mouth with or without food as directed||
0573|052|H|by your doctor, usually once daily at bedtime. The dosage is||
0573|053|H|based on your age, medical condition, and response to treatment.||
0573|054|H|To reduce your risk of side effects, your doctor may start you at||
0573|055|H|a low dose and gradually increase your dose. Teenagers and older||
0573|056|H|adults may need to start with other forms of imipramine (such as||
0573|057|H|imipramine hydrochloride) to start at a dose that is low enough.||
0573|058|H|   Follow your doctor's instructions carefully. Do not take more||
0573|059|H|or less medication or take it more often than prescribed. Your||
0573|060|H|condition will not improve any faster and your risk of side||
0573|061|H|effects will increase. Use this medication regularly in order to||
0573|062|H|get the most benefit from it. To help you remember, use it at the||
0573|063|H|same time(s) each day.||
0573|064|H|   Keep taking this medication even if you feel well. Do not||
0573|065|H|suddenly stop taking this medication without consulting your||
0573|066|H|doctor. Some conditions may become worse when the drug is||
0573|067|H|abruptly stopped. Your dose may need to be gradually decreased.||
0573|068|H|   When this drug is used for depression, it may take up to 3||
0573|069|H|weeks before you experience the full benefits.||
0573|070|H|   Tell your doctor if your condition lasts or gets worse.||
0573|071|B|||
0573|072|S|SIDE EFFECTS:  See also Warning section.||
0573|073|S|   Dry mouth, blurred vision, headache, drowsiness, dizziness,||
0573|074|S|constipation, nausea, vomiting, loss of appetite, diarrhea,||
0573|075|S|stomach cramps, weight gain/loss, and increased sweating may||
0573|076|S|occur. If any of these effects last or get worse, notify your||
0573|077|S|doctor or pharmacist promptly.||
0573|078|S|   To reduce the risk of dizziness and lightheadedness, get up||
0573|079|S|slowly when rising from a sitting or lying position.||
0573|080|S|   Remember that this medication has been prescribed because your||
0573|081|S|doctor has judged that the benefit to you is greater than the||
0573|082|S|risk of side effects. Many people using this medication do not||
0573|083|S|have serious side effects.||
0573|084|S|   Tell your doctor right away if you have any serious side||
0573|085|S|effects, including: mental/mood changes (such as confusion,||
0573|086|S|depression, memory problems), enlarged/painful breasts, unusual||
0573|087|S|breast milk production, irregular/painful menstrual periods,||
0573|088|S|muscle stiffness, restlessness, ringing in the ears, sexual||
0573|089|S|problems (such as decreased sexual ability, changes in desire),||
0573|090|S|shakiness (tremors), numbness/tingling of the hands/feet,||
0573|091|S|pain/redness/swelling of arms or legs, trouble urinating, easy||
0573|092|S|bruising/bleeding, signs of infection (such as sore throat that||
0573|093|S|doesn't go away, fever, chills), severe stomach/abdominal pain,||
0573|094|S|dark urine, yellowing of eyes/skin.||
0573|095|S|   This medication may increase serotonin and rarely cause a very||
0573|096|S|serious condition called serotonin syndrome/toxicity. The risk||
0573|097|S|increases if you are also taking other drugs that increase||
0573|098|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0573|099|S|take (see Drug Interactions section). Get medical help right away||
0573|100|S|if you develop some of the following symptoms: fast heartbeat,||
0573|101|S|hallucinations, loss of coordination, severe dizziness, severe||
0573|102|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0573|103|S|unusual agitation/restlessness.||
0573|104|S|   Get medical help right away if you have any very serious side||
0573|105|S|effects, including: chest pain, slow/fast/irregular heartbeat,||
0573|106|S|fainting, seizures, trouble speaking, weakness on one side of the||
0573|107|S|body, eye pain/swelling/redness, widened pupils, vision changes||
0573|108|S|(such as seeing rainbows around lights at night).||
0573|109|S|   A very serious allergic reaction to this drug is rare.||
0573|110|S|However, get medical help right away if you notice any symptoms||
0573|111|S|of a serious allergic reaction, including: rash, itching/swelling||
0573|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0573|113|S|breathing.||
0573|114|S|   This is not a complete list of possible side effects. If you||
0573|115|S|notice other effects not listed above, contact your doctor or||
0573|116|S|pharmacist.||
0573|117|S|   In the US -||
0573|118|S|   Call your doctor for medical advice about side effects. You||
0573|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0573|120|S|www.fda.gov/medwatch.||
0573|121|S|   In Canada - Call your doctor for medical advice about side||
0573|122|S|effects. You may report side effects to Health Canada at||
0573|123|S|1-866-234-2345.||
0573|124|B|||
0573|125|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0573|126|P|pharmacist if you are allergic to it; or to other tricyclic||
0573|127|P|antidepressants (such as desipramine, amitriptyline); or if you||
0573|128|P|have any other allergies. This product may contain inactive||
0573|129|P|ingredients, which can cause allergic reactions or other||
0573|130|P|problems. Talk to your pharmacist for more details.||
0573|131|P|   Before using this medication, tell your doctor or pharmacist||
0573|132|P|your medical history, especially of: breathing problems (such as||
0573|133|P|asthma, chronic bronchitis), personal or family history of||
0573|134|P|glaucoma (angle-closure type), diabetes, eating disorders (such||
0573|135|P|as bulimia), heart problems (such as arrhythmias, coronary artery||
0573|136|P|disease, heart attack), liver problems, kidney problems, personal||
0573|137|P|or family history of other mental/mood conditions (such as||
0573|138|P|bipolar disorder, schizophrenia), seizures, overactive thyroid||
0573|139|P|(hyperthyroidism), trouble urinating (such as due to enlarged||
0573|140|P|prostate), any condition that may increase your risk of seizures||
0573|141|P|(such as alcohol/sedative dependency, use of electroconvulsive||
0573|142|P|therapy, brain injury/disease such as stroke), certain types of||
0573|143|P|tumors (such as pheochromocytoma, neuroblastoma).||
0573|144|P|   Imipramine pamoate may cause a condition that affects the||
0573|145|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
0573|146|P|serious (rarely fatal) fast/irregular heartbeat and other||
0573|147|P|symptoms (such as severe dizziness, fainting) that need medical||
0573|148|P|attention right away.||
0573|149|P|   The risk of QT prolongation may be increased if you have||
0573|150|P|certain medical conditions or are taking other drugs that may||
0573|151|P|cause QT prolongation. Before using imipramine pamoate, tell your||
0573|152|P|doctor or pharmacist of all the drugs you take and if you have||
0573|153|P|any of the following conditions: certain heart problems (heart||
0573|154|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0573|155|P|history of certain heart problems (QT prolongation in the EKG,||
0573|156|P|sudden cardiac death).||
0573|157|P|   Low levels of potassium or magnesium in the blood may also||
0573|158|P|increase your risk of QT prolongation. This risk may increase if||
0573|159|P|you use certain drugs (such as diuretics/"water pills") or if you||
0573|160|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0573|161|P|Talk to your doctor about using imipramine pamoate safely.||
0573|162|P|   Before having surgery, tell your doctor or dentist about all||
0573|163|P|the products you use (including prescription drugs,||
0573|164|P|nonprescription drugs, and herbal products).||
0573|165|P|   This drug may make you dizzy or drowsy or blur your vision.||
0573|166|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0573|167|P|drowsy. Do not drive, use machinery, or do anything that needs||
0573|168|P|alertness or clear vision until you can do it safely. Limit||
0573|169|P|alcoholic beverages. Talk to your doctor if you are using||
0573|170|P|marijuana (cannabis).||
0573|171|P|   This medication may make you more sensitive to the sun. Limit||
0573|172|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0573|173|P|sunscreen and wear protective clothing when outdoors. Tell your||
0573|174|P|doctor right away if you get sunburned or have skin||
0573|175|P|blisters/redness.||
0573|176|P|   If you have diabetes, this drug may make it harder to control||
0573|177|P|your blood sugar. Check your blood sugar regularly as directed||
0573|178|P|and share the results with your doctor. Tell your doctor right||
0573|179|P|away if you have symptoms such as increased thirst/urination.||
0573|180|P|Your doctor may need to adjust your diabetes medication, exercise||
0573|181|P|program, or diet.||
0573|182|P|   Older adults may be more sensitive to the side effects of this||
0573|183|P|drug, especially dizziness (more likely when standing up),||
0573|184|P|drowsiness, constipation, trouble urinating, mental/mood changes||
0573|185|P|(such as confusion, agitation) and heart effects such as QT||
0573|186|P|prolongation (see above). Dizziness, drowsiness, and confusion||
0573|187|P|can increase the risk of falling.||
0573|188|P|   Children may be more sensitive to the side effects of this||
0573|189|P|drug, especially heart effects.||
0573|190|P|   During pregnancy, this medication should be used only when||
0573|191|P|clearly needed. Infants born to mothers who have taken similar||
0573|192|P|medications during pregnancy may have symptoms such as trouble||
0573|193|P|urinating, prolonged sleepiness, shaking, and seizures. Discuss||
0573|194|P|the risks and benefits with your doctor.||
0573|195|P|   Since untreated mental/mood problems (such as depression,||
0573|196|P|anxiety, panic disorders) can be a serious condition, do not stop||
0573|197|P|taking this medication unless directed by your doctor. If you are||
0573|198|P|planning pregnancy, become pregnant, or think you may be||
0573|199|P|pregnant, immediately discuss with your doctor the benefits and||
0573|200|P|risks of using this medication during pregnancy.||
0573|201|P|   This medication passes into breast milk and may have||
0573|202|P|undesirable effects on a nursing infant. Consult your doctor||
0573|203|P|before breastfeeding.||
0573|204|B|||
0573|205|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0573|206|I|medications work or increase your risk for serious side effects.||
0573|207|I|This document does not contain all possible drug interactions.||
0573|208|I|Keep a list of all the products you use (including||
0573|209|I|prescription/nonprescription drugs and herbal products) and share||
0573|210|I|it with your doctor and pharmacist. Do not start, stop, or change||
0573|211|I|the dosage of any medicines without your doctor's approval.||
0573|212|I|   Some products that may interact with this drug include:||
0573|213|I|certain drugs for high blood pressure (such as clonidine,||
0573|214|I|guanadrel, guanethidine), digoxin, disopyramide, thyroid||
0573|215|I|supplements, valproic acid.||
0573|216|I|   Taking MAO inhibitors with this medication may cause a serious||
0573|217|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0573|218|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0573|219|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0573|220|I|selegiline, tranylcypromine) during treatment with this||
0573|221|I|medication. Most MAO inhibitors should also not be taken for two||
0573|222|I|weeks before and after treatment with this medication. Ask your||
0573|223|I|doctor when to start or stop taking this medication.||
0573|224|I|   The risk of serotonin syndrome/toxicity increases if you are||
0573|225|I|also taking other drugs that increase serotonin. Examples include||
0573|226|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0573|227|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0573|228|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0573|229|I|serotonin syndrome/toxicity may be more likely when you start or||
0573|230|I|increase the dose of these drugs.||
0573|231|I|   Other medications can affect the removal of imipramine pamoate||
0573|232|I|from your body, which may affect how imipramine pamoate works.||
0573|233|I|Examples include barbiturates (such as phenobarbital),||
0573|234|I|cimetidine, haloperidol, certain drugs for heart rhythm (such as||
0573|235|I|flecainide, propafenone), certain HIV protease inhibitors (such||
0573|236|I|as fosamprenavir), phenothiazines (such as thioridazine),||
0573|237|I|pimozide, certain anti-seizure drugs (such as phenytoin),||
0573|238|I|trazodone, among others.||
0573|239|I|   Cigarette smoking decreases blood levels of this medication.||
0573|240|I|Tell your doctor if you smoke or if you have recently stopped||
0573|241|I|smoking.||
0573|242|I|   Many drugs besides imipramine pamoate may affect the heart||
0573|243|I|rhythm (QT prolongation), including amiodarone, dofetilide,||
0573|244|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
0573|245|I|(such as erythromycin), among others. Before using imipramine||
0573|246|I|pamoate, report all medications you are currently using to your||
0573|247|I|doctor or pharmacist.||
0573|248|I|   Tell your doctor or pharmacist if you are taking other||
0573|249|I|products that cause drowsiness including alcohol, marijuana||
0573|250|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0573|251|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0573|252|I|zolpidem), muscle relaxants (such as carisoprodol,||
0573|253|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
0573|254|I|hydrocodone).||
0573|255|I|   Check the labels on all your medicines (such as allergy or||
0573|256|I|cough-and-cold products) because they may contain ingredients||
0573|257|I|that cause drowsiness. Ask your pharmacist about using those||
0573|258|I|products safely.||
0573|259|I|   Imipramine is very similar to desipramine. Do not take||
0573|260|I|medications containing desipramine while using imipramine.||
0573|261|B|||
0573|262|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0573|263|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0573|264|O|poison control center right away. US residents can call||
0573|265|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0573|266|O|Symptoms of overdose may include: severe dizziness,||
0573|267|O|fast/irregular heartbeat, fainting, hallucinations, seizures.||
0573|268|B|||
0573|269|N|NOTES:  Do not share this medication with others.||
0573|270|N|   Lab and/or medical tests (such as blood counts, EKG, kidney||
0573|271|N|function) may be done while you are taking this medication. Keep||
0573|272|N|all medical and lab appointments. Consult your doctor for more||
0573|273|N|details.||
0573|274|B|||
0573|275|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0573|276|D|remember. If it is near the time of the next dose, skip the||
0573|277|D|missed dose. Take your next dose at the regular time. Do not||
0573|278|D|double the dose to catch up.||
0573|279|B|||
0573|280|R|STORAGE:  Store at room temperature away from light and moisture.||
0573|281|R|Do not store in the bathroom. Keep all medications away from||
0573|282|R|children and pets.||
0573|283|R|   Do not flush medications down the toilet or pour them into a||
0573|284|R|drain unless instructed to do so. Properly discard this product||
0573|285|R|when it is expired or no longer needed. Consult your pharmacist||
0573|286|R|or local waste disposal company.||
0573|287|B|||
0573|288|A|Information last revised May 2025.||
0573|289|A|Copyright(c) 2025 First Databank, Inc.||
0573|290|B|||
0574|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0574|002|Z|does NOT have all possible information about this product. This||
0574|003|Z|information does not assure that this product is safe, effective,||
0574|004|Z|or appropriate for you. This information is not individual||
0574|005|Z|medical advice and does not substitute for the advice of your||
0574|006|Z|health care professional. Always ask your health care||
0574|007|Z|professional for complete information about this product and your||
0574|008|Z|specific health needs.||
0574|009|B|||
0574|010|T|IMIPRAMINE - ORAL||
0574|011|F|(ih-MIH-pra-meen)||
0574|012|B|||
0574|013|C|COMMON BRAND NAME(S): Tofranil||
0574|014|B|||
0574|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0574|016|W|of conditions, including depression and other mental/mood||
0574|017|W|disorders. These medications can help prevent suicidal||
0574|018|W|thoughts/attempts and provide other important benefits. However,||
0574|019|W|studies have shown that a small number of people (especially||
0574|020|W|people younger than 25) who take antidepressants for any||
0574|021|W|condition may experience worsening depression, other mental/mood||
0574|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0574|023|W|talk with the doctor about the risks and benefits of||
0574|024|W|antidepressant medication (especially for people younger than||
0574|025|W|25), even if treatment is not for a mental/mood condition.||
0574|026|W|   Tell the doctor right away if you notice worsening||
0574|027|W|depression/other psychiatric conditions, unusual behavior changes||
0574|028|W|(including possible suicidal thoughts/attempts), or other||
0574|029|W|mental/mood changes (including new/worsening anxiety, panic||
0574|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0574|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0574|032|W|especially watchful for these symptoms when a new antidepressant||
0574|033|W|is started or when the dose is changed.||
0574|034|B|||
0574|035|U|USES:  This medication is used to treat depression. It is also||
0574|036|U|used to treat nighttime bed-wetting (enuresis) in children.||
0574|037|U|Imipramine belongs to a class of drugs known as tricyclic||
0574|038|U|antidepressants. It works by helping to restore the balance of||
0574|039|U|certain natural substances in the brain. For bed-wetting, this||
0574|040|U|medication may work by blocking the effect of a certain natural||
0574|041|U|substance (acetylcholine) on the bladder.||
0574|042|B|||
0574|043|V|OTHER USES:  This section contains uses of this drug that are not||
0574|044|V|listed in the approved professional labeling for the drug but||
0574|045|V|that may be prescribed by your health care professional. Use this||
0574|046|V|drug for a condition that is listed in this section only if it||
0574|047|V|has been so prescribed by your health care professional.||
0574|048|V|   This drug may also be used for anxiety, panic disorders, or||
0574|049|V|nerve pain.||
0574|050|B|||
0574|051|H|HOW TO USE:  Read the Medication Guide provided by your||
0574|052|H|pharmacist before you start taking imipramine and each time you||
0574|053|H|get a refill. If you have any questions, ask your doctor or||
0574|054|H|pharmacist.||
0574|055|H|   Take this medication by mouth with or without food as directed||
0574|056|H|by your doctor, usually 1 to 4 times daily. If you have daytime||
0574|057|H|drowsiness, your doctor may direct you to take the entire dose||
0574|058|H|once daily at bedtime. The dosage is based on your medical||
0574|059|H|condition and response to treatment. Children's dosage may also||
0574|060|H|be based on weight. To reduce your risk of side effects, your||
0574|061|H|doctor may start you at a low dose and gradually increase your||
0574|062|H|dose.||
0574|063|H|   When used by children for bed-wetting, imipramine should be||
0574|064|H|taken one hour before bedtime. If your child usually wets the bed||
0574|065|H|early in the night, the drug may be given earlier in separate||
0574|066|H|doses (such as one dose in the afternoon and one dose at||
0574|067|H|bedtime).||
0574|068|H|   Follow your doctor's instructions carefully. Do not take more||
0574|069|H|or less medication or take it more often than prescribed. Your||
0574|070|H|condition will not improve any faster and your risk of side||
0574|071|H|effects will increase. Use this medication regularly in order to||
0574|072|H|get the most benefit from it. To help you remember, use it at the||
0574|073|H|same time(s) each day.||
0574|074|H|   This medication does not work right away. It may take up to 3||
0574|075|H|weeks before you experience the full benefits if you are taking||
0574|076|H|this medication for depression.||
0574|077|H|   Keep taking this medication even if you feel well. Do not||
0574|078|H|suddenly stop taking this medication without consulting your||
0574|079|H|doctor. Some conditions may become worse when the drug is||
0574|080|H|abruptly stopped. Your dose may need to be gradually decreased.||
0574|081|H|   When used for an extended period in children for bed-wetting,||
0574|082|H|this medication may not work as well and may require different||
0574|083|H|dosing. Talk with the doctor if this medication stops working||
0574|084|H|well.||
0574|085|H|   Tell your doctor if your condition lasts or gets worse.||
0574|086|B|||
0574|087|S|SIDE EFFECTS:  See also Warning section.||
0574|088|S|   Dry mouth, blurred vision, headache, drowsiness, dizziness,||
0574|089|S|constipation, nausea, vomiting, loss of appetite, diarrhea,||
0574|090|S|stomach cramps, weight gain/loss, and increased sweating may||
0574|091|S|occur. If any of these effects last or get worse, notify your||
0574|092|S|doctor or pharmacist promptly.||
0574|093|S|   To reduce the risk of dizziness and lightheadedness, get up||
0574|094|S|slowly when rising from a sitting or lying position.||
0574|095|S|   Remember that this medication has been prescribed because your||
0574|096|S|doctor has judged that the benefit to you is greater than the||
0574|097|S|risk of side effects. Many people using this medication do not||
0574|098|S|have serious side effects.||
0574|099|S|   Tell your doctor right away if you have any serious side||
0574|100|S|effects, including: mental/mood changes (such as confusion,||
0574|101|S|depression, memory problems), enlarged/painful breasts, unusual||
0574|102|S|breast milk production, irregular/painful menstrual periods,||
0574|103|S|muscle stiffness, restlessness, ringing in the ears, sexual||
0574|104|S|problems (such as decreased sexual ability, changes in desire),||
0574|105|S|shakiness (tremors), numbness/tingling of the hands/feet,||
0574|106|S|pain/redness/swelling of arms or legs, trouble urinating, easy||
0574|107|S|bruising/bleeding, signs of infection (such as sore throat that||
0574|108|S|doesn't go away, fever, chills), severe stomach/abdominal pain,||
0574|109|S|dark urine, yellowing of eyes/skin.||
0574|110|S|   This medication may increase serotonin and rarely cause a very||
0574|111|S|serious condition called serotonin syndrome/toxicity. The risk||
0574|112|S|increases if you are also taking other drugs that increase||
0574|113|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0574|114|S|take (see Drug Interactions section). Get medical help right away||
0574|115|S|if you develop some of the following symptoms: fast heartbeat,||
0574|116|S|hallucinations, loss of coordination, severe dizziness, severe||
0574|117|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0574|118|S|unusual agitation/restlessness.||
0574|119|S|   Get medical help right away if you have any very serious side||
0574|120|S|effects, including: chest pain, slow/fast/irregular heartbeat,||
0574|121|S|fainting, seizures, trouble speaking, weakness on one side of the||
0574|122|S|body, eye pain/swelling/redness, widened pupils, vision changes||
0574|123|S|(such as seeing rainbows around lights at night).||
0574|124|S|   A very serious allergic reaction to this drug is rare.||
0574|125|S|However, get medical help right away if you notice any symptoms||
0574|126|S|of a serious allergic reaction, including: rash, itching/swelling||
0574|127|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0574|128|S|breathing.||
0574|129|S|   This is not a complete list of possible side effects. If you||
0574|130|S|notice other effects not listed above, contact your doctor or||
0574|131|S|pharmacist.||
0574|132|S|   In the US -||
0574|133|S|   Call your doctor for medical advice about side effects. You||
0574|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0574|135|S|www.fda.gov/medwatch.||
0574|136|S|   In Canada - Call your doctor for medical advice about side||
0574|137|S|effects. You may report side effects to Health Canada at||
0574|138|S|1-866-234-2345.||
0574|139|B|||
0574|140|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0574|141|P|pharmacist if you are allergic to it; or to other tricyclic||
0574|142|P|antidepressants (such as desipramine, amitriptyline); or if you||
0574|143|P|have any other allergies. This product may contain inactive||
0574|144|P|ingredients, which can cause allergic reactions or other||
0574|145|P|problems. Talk to your pharmacist for more details.||
0574|146|P|   Before using this medication, tell your doctor or pharmacist||
0574|147|P|your medical history, especially of: breathing problems (such as||
0574|148|P|asthma, chronic bronchitis), personal or family history of||
0574|149|P|glaucoma (angle-closure type), diabetes, eating disorders (such||
0574|150|P|as bulimia), heart problems (such as arrhythmias, coronary artery||
0574|151|P|disease, heart attack), liver problems, kidney problems, personal||
0574|152|P|or family history of other mental/mood conditions (such as||
0574|153|P|bipolar disorder, schizophrenia), seizures, overactive thyroid||
0574|154|P|(hyperthyroidism), trouble urinating (such as due to enlarged||
0574|155|P|prostate), any condition that may increase your risk of seizures||
0574|156|P|(including alcohol/sedative dependency, use of electroconvulsive||
0574|157|P|therapy, brain injury/disease such as stroke), certain types of||
0574|158|P|tumors (such as pheochromocytoma, neuroblastoma).||
0574|159|P|   Imipramine may cause a condition that affects the heart rhythm||
0574|160|P|(QT prolongation). QT prolongation can rarely cause serious||
0574|161|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0574|162|P|as severe dizziness, fainting) that need medical attention right||
0574|163|P|away.||
0574|164|P|   The risk of QT prolongation may be increased if you have||
0574|165|P|certain medical conditions or are taking other drugs that may||
0574|166|P|cause QT prolongation. Before using imipramine, tell your doctor||
0574|167|P|or pharmacist of all the drugs you take and if you have any of||
0574|168|P|the following conditions: certain heart problems (heart failure,||
0574|169|P|slow heartbeat, QT prolongation in the EKG), family history of||
0574|170|P|certain heart problems (QT prolongation in the EKG, sudden||
0574|171|P|cardiac death).||
0574|172|P|   Low levels of potassium or magnesium in the blood may also||
0574|173|P|increase your risk of QT prolongation. This risk may increase if||
0574|174|P|you use certain drugs (such as diuretics/"water pills") or if you||
0574|175|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0574|176|P|Talk to your doctor about using imipramine safely.||
0574|177|P|   Before having surgery, tell your doctor or dentist about all||
0574|178|P|the products you use (including prescription drugs,||
0574|179|P|nonprescription drugs, and herbal products).||
0574|180|P|   This drug may make you dizzy or drowsy or blur your vision.||
0574|181|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0574|182|P|drowsy. Do not drive, use machinery, or do anything that needs||
0574|183|P|alertness or clear vision until you can do it safely. Limit||
0574|184|P|alcoholic beverages. Talk to your doctor if you are using||
0574|185|P|marijuana (cannabis).||
0574|186|P|   This medication may make you more sensitive to the sun. Limit||
0574|187|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0574|188|P|sunscreen and wear protective clothing when outdoors. Tell your||
0574|189|P|doctor right away if you get sunburned or have skin||
0574|190|P|blisters/redness.||
0574|191|P|   If you have diabetes, this drug may make it harder to control||
0574|192|P|your blood sugar. Check your blood sugar regularly as directed||
0574|193|P|and share the results with your doctor. Tell your doctor right||
0574|194|P|away if you have symptoms such as increased thirst/urination.||
0574|195|P|Your doctor may need to adjust your diabetes medication, exercise||
0574|196|P|program, or diet.||
0574|197|P|   Older adults may be more sensitive to the side effects of this||
0574|198|P|drug, especially dizziness (more likely when standing up),||
0574|199|P|drowsiness, constipation, trouble urinating, mental/mood changes||
0574|200|P|(such as confusion, agitation) and heart effects such as QT||
0574|201|P|prolongation (see above). Dizziness, drowsiness, and confusion||
0574|202|P|can increase the risk of falling.||
0574|203|P|   Children may be more sensitive to the side effects of this||
0574|204|P|drug, especially heart effects.||
0574|205|P|   During pregnancy, this medication should be used only when||
0574|206|P|clearly needed. Infants born to mothers who have taken similar||
0574|207|P|medications during pregnancy may have symptoms such as trouble||
0574|208|P|urinating, prolonged sleepiness, shaking, and seizures. Discuss||
0574|209|P|the risks and benefits with your doctor.||
0574|210|P|   Since untreated mental/mood problems (such as depression,||
0574|211|P|anxiety, panic disorders) can be a serious condition, do not stop||
0574|212|P|taking this medication unless directed by your doctor. If you are||
0574|213|P|planning pregnancy, become pregnant, or think you may be||
0574|214|P|pregnant, immediately discuss with your doctor the benefits and||
0574|215|P|risks of using this medication during pregnancy.||
0574|216|P|   This medication passes into breast milk and may have||
0574|217|P|undesirable effects on a nursing infant. Consult your doctor||
0574|218|P|before breastfeeding.||
0574|219|B|||
0574|220|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0574|221|I|medications work or increase your risk for serious side effects.||
0574|222|I|This document does not contain all possible drug interactions.||
0574|223|I|Keep a list of all the products you use (including||
0574|224|I|prescription/nonprescription drugs and herbal products) and share||
0574|225|I|it with your doctor and pharmacist. Do not start, stop, or change||
0574|226|I|the dosage of any medicines without your doctor's approval.||
0574|227|I|   Some products that may interact with this drug include:||
0574|228|I|certain drugs for high blood pressure (such as clonidine,||
0574|229|I|guanadrel, guanethidine), digoxin, disopyramide, thyroid||
0574|230|I|supplements, valproic acid.||
0574|231|I|   Taking MAO inhibitors with this medication may cause a serious||
0574|232|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0574|233|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0574|234|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0574|235|I|selegiline, tranylcypromine) during treatment with this||
0574|236|I|medication. Most MAO inhibitors should also not be taken for two||
0574|237|I|weeks before and after treatment with this medication. Ask your||
0574|238|I|doctor when to start or stop taking this medication.||
0574|239|I|   The risk of serotonin syndrome/toxicity increases if you are||
0574|240|I|also taking other drugs that increase serotonin. Examples include||
0574|241|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0574|242|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0574|243|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0574|244|I|serotonin syndrome/toxicity may be more likely when you start or||
0574|245|I|increase the dose of these drugs.||
0574|246|I|   Other medications can affect the removal of imipramine from||
0574|247|I|your body, which may affect how imipramine works. Examples||
0574|248|I|include barbiturates (such as phenobarbital), cimetidine,||
0574|249|I|haloperidol, certain drugs for heart rhythm (such as flecainide,||
0574|250|I|propafenone), certain HIV protease inhibitors (such as||
0574|251|I|fosamprenavir), phenothiazines (such as thioridazine), pimozide,||
0574|252|I|certain anti-seizure drugs (such as phenytoin), trazodone, among||
0574|253|I|others.||
0574|254|I|   Many drugs besides imipramine may affect the heart rhythm (QT||
0574|255|I|prolongation), including amiodarone, dofetilide, pimozide,||
0574|256|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
0574|257|I|erythromycin), among others. Before using imipramine, report all||
0574|258|I|medications you are currently using to your doctor or pharmacist.||
0574|259|I|   Tell your doctor or pharmacist if you are taking other||
0574|260|I|products that cause drowsiness including alcohol, marijuana||
0574|261|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0574|262|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0574|263|I|zolpidem), muscle relaxants (such as carisoprodol,||
0574|264|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
0574|265|I|hydrocodone).||
0574|266|I|   Check the labels on all your medicines (such as allergy or||
0574|267|I|cough-and-cold products) because they may contain ingredients||
0574|268|I|that cause drowsiness. Ask your pharmacist about using those||
0574|269|I|products safely.||
0574|270|I|   Cigarette smoking decreases blood levels of this medication.||
0574|271|I|Tell your doctor if you smoke or if you have recently stopped||
0574|272|I|smoking.||
0574|273|I|   Imipramine is very similar to desipramine. Do not take||
0574|274|I|medications containing desipramine while using imipramine.||
0574|275|B|||
0574|276|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0574|277|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0574|278|O|poison control center right away. US residents can call||
0574|279|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0574|280|O|Symptoms of overdose may include: severe dizziness,||
0574|281|O|fast/irregular heartbeat, fainting, hallucinations, seizures.||
0574|282|B|||
0574|283|N|NOTES:  Do not share this medication with others.||
0574|284|N|   Lab and/or medical tests (such as blood counts, EKG, kidney||
0574|285|N|function) may be done while you are taking this medication. Keep||
0574|286|N|all medical and lab appointments. Consult your doctor for more||
0574|287|N|details.||
0574|288|B|||
0574|289|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0574|290|D|remember. If it is near the time of the next dose, skip the||
0574|291|D|missed dose. Take your next dose at the regular time. Do not||
0574|292|D|double the dose to catch up.||
0574|293|B|||
0574|294|R|STORAGE:  Store at room temperature away from light and moisture.||
0574|295|R|Do not store in the bathroom. Keep all medications away from||
0574|296|R|children and pets.||
0574|297|R|   Do not flush medications down the toilet or pour them into a||
0574|298|R|drain unless instructed to do so. Properly discard this product||
0574|299|R|when it is expired or no longer needed. Consult your pharmacist||
0574|300|R|or local waste disposal company.||
0574|301|B|||
0574|302|A|Information last revised May 2025.||
0574|303|A|Copyright(c) 2025 First Databank, Inc.||
0574|304|B|||
0575|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0575|002|Z|does NOT have all possible information about this product. This||
0575|003|Z|information does not assure that this product is safe, effective,||
0575|004|Z|or appropriate for you. This information is not individual||
0575|005|Z|medical advice and does not substitute for the advice of your||
0575|006|Z|health care professional. Always ask your health care||
0575|007|Z|professional for complete information about this product and your||
0575|008|Z|specific health needs.||
0575|009|B|||
0575|010|T|PROPRANOLOL/HYDROCHLOROTHIAZIDE - ORAL||
0575|011|F|(pro-PRAN-oh-lol/HYE-droe-KLOR-oh-THYE-a-zide)||
0575|012|B|||
0575|013|C|COMMON BRAND NAME(S): Inderide||
0575|014|B|||
0575|015|W|WARNING:  Do not stop using this drug without first consulting||
0575|016|W|your doctor. Your condition may become worse when the drug is||
0575|017|W|suddenly stopped, especially if you have chest pain (angina) or||
0575|018|W|heart disease (such as coronary artery disease, ischemic heart||
0575|019|W|disease, high blood pressure). If your doctor decides you should||
0575|020|W|no longer use this drug, you must gradually decrease your dose||
0575|021|W|according to your doctor's instructions.||
0575|022|W|   When gradually stopping this medication, it is recommended||
0575|023|W|that you temporarily limit physical activity to decrease strain||
0575|024|W|on the heart. Get medical help right away if you develop:||
0575|025|W|worsening chest pain, tightness/pressure in the chest, chest pain||
0575|026|W|spreading to the jaw/neck/arm, unusual sweating, trouble||
0575|027|W|breathing, or fast/irregular heartbeat.||
0575|028|B|||
0575|029|U|USES:  This product is used to treat high blood pressure||
0575|030|U|(hypertension). Lowering high blood pressure helps prevent||
0575|031|U|strokes, heart attacks, and kidney problems.||
0575|032|U|   This product contains 2 medications. Propranolol is a beta||
0575|033|U|blocker that works by blocking certain natural chemicals in your||
0575|034|U|body (such as epinephrine) that affect the heart and blood||
0575|035|U|vessels. This effect reduces heart rate, blood pressure, and||
0575|036|U|strain on the heart. Hydrochlorothiazide is called a "water pill"||
0575|037|U|(diuretic) and causes your body to get rid of extra salt and||
0575|038|U|water. This effect may increase the amount of urine you make when||
0575|039|U|you first start the medication. It also helps to relax the blood||
0575|040|U|vessels so that blood can flow through the body more easily.||
0575|041|U|   These medications are used together when 1 drug is not||
0575|042|U|controlling your blood pressure. Your doctor should direct you to||
0575|043|U|start taking the individual medications first, and then switch||
0575|044|U|you over to this combination product if this is the best dose||
0575|045|U|combination for you.||
0575|046|B|||
0575|047|H|HOW TO USE:  See also Warning section.||
0575|048|H|   Take this medication by mouth as directed by your doctor,||
0575|049|H|usually twice daily. You may take this medication with or without||
0575|050|H|food, but it is important to choose one way and take this||
0575|051|H|medication the same way with every dose.||
0575|052|H|   The dosage is based on your medical condition and response to||
0575|053|H|treatment.||
0575|054|H|   If you take this drug too close to bedtime, you may need to||
0575|055|H|wake up to urinate. It is best to take this medication at least 4||
0575|056|H|hours before your bedtime. Consult your doctor or pharmacist if||
0575|057|H|you have questions about your dosing schedule.||
0575|058|H|   If you also take certain drugs to lower your cholesterol (bile||
0575|059|H|acid-binding resins such as cholestyramine or colestipol), take||
0575|060|H|this product at least 4 hours before or at least 4 to 6 hours||
0575|061|H|after these medications.||
0575|062|H|   Use this medication regularly to get the most benefit from it.||
0575|063|H|To help you remember, take it at the same times each day. Keep||
0575|064|H|taking this medication even if you feel well. Most people with||
0575|065|H|high blood pressure do not feel sick. It may take up to several||
0575|066|H|weeks before you get the full benefit of this drug.||
0575|067|H|   Tell your doctor if your condition does not get better or if||
0575|068|H|it gets worse (your blood pressure readings remain high or||
0575|069|H|increase).||
0575|070|B|||
0575|071|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
0575|072|S|   Dizziness, lightheadedness, blurred vision, or tiredness may||
0575|073|S|occur as your body adjusts to the medication. Nausea/vomiting,||
0575|074|S|stomach pain, and unusual dreams may also occur. If any of these||
0575|075|S|effects last or get worse, tell your doctor or pharmacist||
0575|076|S|promptly.||
0575|077|S|   To reduce the risk of dizziness and lightheadedness, get up||
0575|078|S|slowly when rising from a sitting or lying position.||
0575|079|S|   Propranolol may reduce blood flow to your hands and feet,||
0575|080|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0575|081|S|warmly and avoid tobacco use.||
0575|082|S|   Remember that this medication has been prescribed because your||
0575|083|S|doctor has judged that the benefit to you is greater than the||
0575|084|S|risk of side effects. Many people using this medication do not||
0575|085|S|have serious side effects.||
0575|086|S|   This product may cause dehydration and electrolyte imbalance.||
0575|087|S|Tell your doctor right away if you have any of these serious||
0575|088|S|symptoms of dehydration or electrolyte imbalance, including||
0575|089|S|unusual dry mouth/thirst, muscle cramps/weakness,||
0575|090|S|slow/fast/irregular heartbeat, or confusion.||
0575|091|S|   Tell your doctor right away if you have any serious side||
0575|092|S|effects, including: fainting, blue fingers/toes, mental/mood||
0575|093|S|changes (such as depression), numbness/tingling of arms/legs, new||
0575|094|S|or worsening symptoms of heart failure (such as shortness of||
0575|095|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
0575|096|S|weight gain), very slow heartbeat, decreased sexual ability,||
0575|097|S|increased thirst/urination, decrease in vision, eye pain, easy||
0575|098|S|bruising/bleeding, signs of infection (such as sore throat that||
0575|099|S|doesn't go away, fever, chills), aching/swollen joints, signs of||
0575|100|S|liver problems (such as nausea/vomiting that doesn't stop,||
0575|101|S|yellowing eyes/skin, stomach/abdominal pain, dark urine), signs||
0575|102|S|of kidney problems (such as change in the amount of urine).||
0575|103|S|   A very serious allergic reaction to this drug is rare.||
0575|104|S|However, get medical help right away if you notice any symptoms||
0575|105|S|of a serious allergic reaction, including: rash, itching/swelling||
0575|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0575|107|S|breathing.||
0575|108|S|   This is not a complete list of possible side effects. If you||
0575|109|S|notice other effects not listed above, contact your doctor or||
0575|110|S|pharmacist.||
0575|111|S|   In the US -||
0575|112|S|   Call your doctor for medical advice about side effects. You||
0575|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0575|114|S|www.fda.gov/medwatch.||
0575|115|S|   In Canada - Call your doctor for medical advice about side||
0575|116|S|effects. You may report side effects to Health Canada at||
0575|117|S|1-866-234-2345.||
0575|118|B|||
0575|119|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0575|120|P|pharmacist if you are allergic to propranolol or||
0575|121|P|hydrochlorothiazide; or to other thiazides (such as||
0575|122|P|chlorothiazide); or if you have had a serious reaction to other||
0575|123|P|beta blockers (such as metoprolol, atenolol); or if you have any||
0575|124|P|other allergies. This product may contain inactive ingredients,||
0575|125|P|which can cause allergic reactions or other problems. Talk to||
0575|126|P|your pharmacist for more details.||
0575|127|P|   Before using this medication, tell your doctor or pharmacist||
0575|128|P|your medical history, especially of: breathing problems (such as||
0575|129|P|asthma, bronchitis, emphysema), diabetes, heart failure, certain||
0575|130|P|types of heart rhythm problems (sinus bradycardia,||
0575|131|P|Wolff-Parkinson-White syndrome, second- or third-degree||
0575|132|P|atrioventricular block), overactive thyroid (hyperthyroidism),||
0575|133|P|kidney disease, liver disease, blood circulation problems (such||
0575|134|P|as Raynaud's disease), a certain adrenal gland tumor||
0575|135|P|(pheochromocytoma), mental/mood disorders (such as depression),||
0575|136|P|certain muscle/nerve disease (myasthenia gravis), gout,||
0575|137|P|dehydration, lupus, certain recent nerve surgery (sympathectomy),||
0575|138|P|severe allergic reactions, untreated mineral imbalance (such as||
0575|139|P|low potassium/magnesium, high calcium), skin cancer.||
0575|140|P|   Before having surgery, tell your doctor or dentist about all||
0575|141|P|the products you use (including prescription drugs,||
0575|142|P|nonprescription drugs, and herbal products).||
0575|143|P|   This drug may make you dizzy or blur your vision. Alcohol or||
0575|144|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
0575|145|P|machinery, or do anything that needs alertness or clear vision||
0575|146|P|until you can do it safely. Limit alcoholic beverages. Talk to||
0575|147|P|your doctor if you are using marijuana (cannabis).||
0575|148|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0575|149|P|and cause you to feel lightheaded. Tell your doctor if you have||
0575|150|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0575|151|P|of fluids unless your doctor tells you not to.||
0575|152|P|   This drug may reduce the potassium levels in your blood. Ask||
0575|153|P|your doctor about increasing the amount of potassium in your diet||
0575|154|P|(such as by eating bananas or drinking orange juice) or about||
0575|155|P|using a salt substitute containing potassium. A potassium||
0575|156|P|supplement may be prescribed by your doctor.||
0575|157|P|   This product may prevent the fast/pounding heartbeat you would||
0575|158|P|usually feel when your blood sugar level falls too low||
0575|159|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0575|160|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0575|161|P|blood sugar level, such as dizziness and sweating, are not||
0575|162|P|affected by this drug.||
0575|163|P|   If you have diabetes, this product may make it harder to||
0575|164|P|control your blood sugar levels. Check your blood sugar levels||
0575|165|P|regularly as directed by your doctor. Tell your doctor right away||
0575|166|P|if you have symptoms of high blood sugar such as increased||
0575|167|P|thirst/urination. Your doctor may need to adjust your diabetes||
0575|168|P|medication, exercise program, or diet.||
0575|169|P|   This medication may make you more sensitive to the sun. It may||
0575|170|P|also increase your risk for skin cancer, especially if you take||
0575|171|P|it for a long time. Limit your time in the sun. Avoid tanning||
0575|172|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0575|173|P|when outdoors. Tell your doctor right away if you get sunburned,||
0575|174|P|have skin blisters/redness, or notice new or changed moles/skin||
0575|175|P|lesions.||
0575|176|P|   Older adults may be more sensitive to the effects of this||
0575|177|P|product, especially dizziness.||
0575|178|P|   During pregnancy, this product should be used only when||
0575|179|P|clearly needed. Infants exposed to the medications in this||
0575|180|P|product during pregnancy may have low birth weight, low blood||
0575|181|P|sugar, slow breathing/heartbeat, liver problems, or bleeding||
0575|182|P|problems. Discuss the risks and benefits with your doctor.||
0575|183|P|   The medications in this product pass into breast milk. Consult||
0575|184|P|your doctor before breastfeeding.||
0575|185|B|||
0575|186|I|DRUG INTERACTIONS:  See also How to Use section.||
0575|187|I|   Drug interactions may change how your medications work or||
0575|188|I|increase your risk for serious side effects. This document does||
0575|189|I|not contain all possible drug interactions. Keep a list of all||
0575|190|I|the products you use (including prescription/nonprescription||
0575|191|I|drugs and herbal products) and share it with your doctor and||
0575|192|I|pharmacist. Do not start, stop, or change the dosage of any||
0575|193|I|medicines without your doctor's approval.||
0575|194|I|   Some products that may interact with this drug are:||
0575|195|I|dofetilide, epinephrine, fingolimod, lithium.||
0575|196|I|   Other medications can affect the removal of propranolol from||
0575|197|I|your body, which may affect how propranolol works. Examples||
0575|198|I|include quinidine, rifamycins (such as rifabutin), among others.||
0575|199|I|   This medication can slow down the removal of other medications||
0575|200|I|from your body, which may affect how they work. Examples of||
0575|201|I|affected drugs include fezolinetant, propafenone, thioridazine,||
0575|202|I|among others.||
0575|203|I|   Some products have ingredients that could raise your heart||
0575|204|I|rate or blood pressure. Tell your pharmacist what products you||
0575|205|I|are using, and ask how to use them safely (especially||
0575|206|I|cough-and-cold products, diet aids, or NSAIDs such as||
0575|207|I|ibuprofen/naproxen).||
0575|208|I|   This medication may interfere with certain lab tests (such as||
0575|209|I|glaucoma screening test, parathyroid test, protein-bound iodide||
0575|210|I|test), possibly causing false test results. Make sure lab||
0575|211|I|personnel and all your doctors know you use this drug.||
0575|212|B|||
0575|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0575|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0575|215|O|poison control center right away. US residents can call||
0575|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0575|217|O|Symptoms of overdose may include: very slow heartbeat, severe||
0575|218|O|dizziness, fainting, trouble breathing.||
0575|219|B|||
0575|220|N|NOTES:  Do not share this medication with others.||
0575|221|N|   Lifestyle changes such as stress reduction programs, exercise,||
0575|222|N|and dietary changes may increase the effectiveness of this||
0575|223|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0575|224|N|changes that might benefit you.||
0575|225|N|   Lab and/or medical tests (such as liver/kidney function,||
0575|226|N|complete blood counts, skin exams, cholesterol levels, blood||
0575|227|N|mineral levels such as potassium) should be done while you are||
0575|228|N|taking this medication. Keep all medical and lab appointments.||
0575|229|N|Consult your doctor for more details.||
0575|230|N|   Have your blood pressure and heart rate checked regularly||
0575|231|N|while taking this medication. Learn how to monitor your own blood||
0575|232|N|pressure and heart rate at home, and share the readings with your||
0575|233|N|doctor.||
0575|234|B|||
0575|235|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0575|236|D|remember. If it is near the time of the next dose, skip the||
0575|237|D|missed dose. Take your next dose at the regular time. Do not||
0575|238|D|double the dose to catch up.||
0575|239|B|||
0575|240|R|STORAGE:  Store at room temperature away from light and moisture.||
0575|241|R|Do not store in the bathroom. Keep all medications away from||
0575|242|R|children and pets.||
0575|243|R|   Do not flush medications down the toilet or pour them into a||
0575|244|R|drain unless instructed to do so. Properly discard this product||
0575|245|R|when it is expired or no longer needed. Consult your pharmacist||
0575|246|R|or local waste disposal company.||
0575|247|B|||
0575|248|A|Information last revised April 2025.||
0575|249|A|Copyright(c) 2025 First Databank, Inc.||
0575|250|B|||
0576|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0576|002|Z|does NOT have all possible information about this product. This||
0576|003|Z|information does not assure that this product is safe, effective,||
0576|004|Z|or appropriate for you. This information is not individual||
0576|005|Z|medical advice and does not substitute for the advice of your||
0576|006|Z|health care professional. Always ask your health care||
0576|007|Z|professional for complete information about this product and your||
0576|008|Z|specific health needs.||
0576|009|B|||
0576|010|T|SALICYLIC ACID 6% - TOPICAL||
0576|011|F|(SAL-i-SIL-ik)||
0576|012|B|||
0576|013|C|COMMON BRAND NAME(S): Salex||
0576|014|B|||
0576|015|U|USES:  Salicylic acid is used on the skin to treat psoriasis and||
0576|016|U|other dry, scaly skin conditions. This medication is also used to||
0576|017|U|help remove dead skin from warts, the palms of the hands, and the||
0576|018|U|soles of the feet. It belongs to the same class of drugs as||
0576|019|U|aspirin (salicylates). This medication should not be used by||
0576|020|U|children younger than 2 years.||
0576|021|U|   Salicylic acid causes the skin to shed dead cells from its top||
0576|022|U|layer by increasing the amount of moisture in the skin and||
0576|023|U|dissolving the "cement" between the cells. This makes it easier||
0576|024|U|to shed the skin cells, softens the top layer of skin, and||
0576|025|U|decreases scaling and dryness.||
0576|026|B|||
0576|027|H|HOW TO USE:  This medication is for use on the skin only. For||
0576|028|H|best results, soak the skin area in warm water for at least 5||
0576|029|H|minutes before using this medication. After soaking, gently wipe||
0576|030|H|off any loose skin with a clean, soft cloth. Do not rub. Apply a||
0576|031|H|thin film of medication to the affected area as directed by your||
0576|032|H|doctor, usually once daily at bedtime. Cover the area loosely if||
0576|033|H|directed by your doctor. When you wake up, gently wash off the||
0576|034|H|medication. Wash hands after use, unless you are using this||
0576|035|H|medication to treat the hands.||
0576|036|H|   If you are using the foam, shake the can well before using.||
0576|037|H|Before using a new can, prime the container by pressing down for||
0576|038|H|3 to 5 seconds until foam appears. Spray the foam onto the hand,||
0576|039|H|then apply. After applying the foam, gently rub it in until it||
0576|040|H|disappears.||
0576|041|H|   Moisture is very important to help the medication work, so||
0576|042|H|your doctor may direct you to cover the treated area to help hold||
0576|043|H|moisture next to the skin. Do not cover the area with ointment,||
0576|044|H|plastic/waterproof bandages, tight-fitting clothing, or tight||
0576|045|H|dressings unless directed by your doctor. Doing so may increase||
0576|046|H|side effects. If you are treating an area that is difficult to||
0576|047|H|cover, your doctor may direct you to moisten the skin with wet||
0576|048|H|packs or baths or to use the medication more often. Use exactly||
0576|049|H|as prescribed.||
0576|050|H|   This medication may be used on the body, the scalp, the palms||
0576|051|H|of the hands, and the soles of the feet. Avoid your eyes,||
0576|052|H|nostrils, mouth, and genitals. If contact occurs, flush the area||
0576|053|H|with cool water for 15 minutes. Be careful when applying this||
0576|054|H|medication because it can irritate normal skin around the treated||
0576|055|H|area.||
0576|056|H|   Do not use large amounts, apply it more often, or use it for a||
0576|057|H|longer time than directed. Your condition will not clear faster,||
0576|058|H|but the chance for side effects may be increased.||
0576|059|H|   You will usually see some improvement in 2 to 3 days, but it||
0576|060|H|may take longer to get the full benefit. Once your skin has||
0576|061|H|improved, your doctor may direct you to use this product only||
0576|062|H|occasionally or to stop using it. Tell your doctor if your||
0576|063|H|condition lasts or gets worse.||
0576|064|B|||
0576|065|S|SIDE EFFECTS:  Burning, redness, and peeling skin near the||
0576|066|S|treated area may occur. If any of these effects last or get||
0576|067|S|worse, contact your doctor or pharmacist promptly.||
0576|068|S|   Remember that this medication has been prescribed because your||
0576|069|S|doctor has judged that the benefit to you is greater than the||
0576|070|S|risk of side effects. Many people using this medication do not||
0576|071|S|have serious side effects.||
0576|072|S|   People who use this drug for a long time or over large areas||
0576|073|S|of skin may rarely have serious side effects caused by this drug||
0576|074|S|entering the bloodstream. Children younger than 12 years and||
0576|075|S|people with liver or kidney problems are more at risk. Tell your||
0576|076|S|doctor right away if any of these serious side effects occur:||
0576|077|S|unexplained nausea/vomiting/diarrhea, rapid breathing, dizziness,||
0576|078|S|hearing problems (such as ringing in the ears, hearing loss),||
0576|079|S|mental/mood changes, tiredness.||
0576|080|S|   A very serious allergic reaction to this drug is rare.||
0576|081|S|However, get medical help right away if you notice any symptoms||
0576|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0576|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0576|084|S|breathing.||
0576|085|S|   This is not a complete list of possible side effects. If you||
0576|086|S|notice other effects not listed above, contact your doctor or||
0576|087|S|pharmacist.||
0576|088|S|   In the US -||
0576|089|S|   Call your doctor for medical advice about side effects. You||
0576|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0576|091|S|www.fda.gov/medwatch.||
0576|092|S|   In Canada - Call your doctor for medical advice about side||
0576|093|S|effects. You may report side effects to Health Canada at||
0576|094|S|1-866-234-2345.||
0576|095|B|||
0576|096|P|PRECAUTIONS:  Before using salicylic acid, tell your doctor or||
0576|097|P|pharmacist if you are allergic to it; or to aspirin; or if you||
0576|098|P|have any other allergies. This product may contain inactive||
0576|099|P|ingredients, which can cause allergic reactions or other||
0576|100|P|problems. Talk to your pharmacist for more details.||
0576|101|P|   Before using this medication, tell your doctor or pharmacist||
0576|102|P|your medical history, especially of: kidney problems, liver||
0576|103|P|problems.||
0576|104|P|   Before having surgery, tell your doctor or dentist about all||
0576|105|P|the products you use (including prescription drugs,||
0576|106|P|nonprescription drugs, and herbal products).||
0576|107|P|   Children may be at greater risk for rare side effects from||
0576|108|P|absorbing this medication into the bloodstream. (See Side Effects||
0576|109|P|for more information.) This drug is similar to aspirin. Children||
0576|110|P|and teenagers younger than 18 years should not use this drug if||
0576|111|P|they have chickenpox, flu, or any undiagnosed illness or if they||
0576|112|P|have recently received a vaccine. In these cases, this drug may||
0576|113|P|increase the risk of Reye's syndrome, a rare but serious illness.||
0576|114|P|   During pregnancy, this product should be used only when||
0576|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
0576|116|P|   It is unknown if this product passes into breast milk. Consult||
0576|117|P|your doctor before breastfeeding.||
0576|118|B|||
0576|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0576|120|I|medications work or increase your risk for serious side effects.||
0576|121|I|This document does not contain all possible drug interactions.||
0576|122|I|Keep a list of all the products you use (including||
0576|123|I|prescription/nonprescription drugs and herbal products) and share||
0576|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
0576|125|I|the dosage of any medicines without your doctor's approval.||
0576|126|I|   Some products that may interact with this drug are:||
0576|127|I|methotrexate, other aspirin/salicylate products, "water pills"||
0576|128|I|(diuretics).||
0576|129|B|||
0576|130|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0576|131|O|has overdosed and has serious symptoms such as passing out or||
0576|132|O|trouble breathing, call 911. Otherwise, call a poison control||
0576|133|O|center right away. US residents can call 1-800-222-1222. Canada||
0576|134|O|residents can call 1-844-764-7669.||
0576|135|B|||
0576|136|N|NOTES:  Do not share this medication with others.||
0576|137|N|   Avoid getting this medication on clothing, wood, plastic,||
0576|138|N|metal, or other surfaces because it can cause damage.||
0576|139|B|||
0576|140|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0576|141|D|If it is near the time of the next dose, skip the missed dose.||
0576|142|D|Use your next dose at the regular time. Do not double the dose to||
0576|143|D|catch up.||
0576|144|B|||
0576|145|R|STORAGE:  Store at room temperature away from heat. Do not||
0576|146|R|freeze. Store the foam canister upright. The contents of this||
0576|147|R|canister are under pressure. Do not burn or puncture the||
0576|148|R|canister. Keep all medications away from children and pets.||
0576|149|R|   Do not flush medications down the toilet or pour them into a||
0576|150|R|drain unless instructed to do so. Properly discard this product||
0576|151|R|when it is expired or no longer needed. Consult your pharmacist||
0576|152|R|or local waste disposal company.||
0576|153|B|||
0576|154|A|Information last revised May 2024.||
0576|155|A|Copyright(c) 2025 First Databank, Inc.||
0576|156|B|||
0578|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0578|002|Z|does NOT have all possible information about this product. This||
0578|003|Z|information does not assure that this product is safe, effective,||
0578|004|Z|or appropriate for you. This information is not individual||
0578|005|Z|medical advice and does not substitute for the advice of your||
0578|006|Z|health care professional. Always ask your health care||
0578|007|Z|professional for complete information about this product and your||
0578|008|Z|specific health needs.||
0578|009|B|||
0578|010|T|DESIPRAMINE - ORAL||
0578|011|F|(des-IP-ra-meen)||
0578|012|B|||
0578|013|C|COMMON BRAND NAME(S): Norpramin||
0578|014|B|||
0578|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0578|016|W|of conditions, including depression and other mental/mood||
0578|017|W|disorders. These medications can help prevent suicidal||
0578|018|W|thoughts/attempts and provide other important benefits. However,||
0578|019|W|studies have shown that a small number of people (especially||
0578|020|W|people younger than 25) who take antidepressants for any||
0578|021|W|condition may experience worsening depression, other mental/mood||
0578|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0578|023|W|talk with the doctor about the risks and benefits of||
0578|024|W|antidepressant medication (especially for people younger than||
0578|025|W|25), even if treatment is not for a mental/mood condition.||
0578|026|W|   Tell the doctor right away if you notice worsening||
0578|027|W|depression/other psychiatric conditions, unusual behavior changes||
0578|028|W|(including possible suicidal thoughts/attempts), or other||
0578|029|W|mental/mood changes (including new/worsening anxiety, panic||
0578|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0578|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0578|032|W|especially watchful for these symptoms when a new antidepressant||
0578|033|W|is started or when the dose is changed.||
0578|034|B|||
0578|035|U|USES:  This medication is used to treat depression. Desipramine||
0578|036|U|belongs to a class of drugs known as tricyclic antidepressants.||
0578|037|U|It works by helping to restore the balance of certain natural||
0578|038|U|substances in the brain.||
0578|039|U|   This drug is not recommended for use in children younger than||
0578|040|U|18 years due to risk of serious side effects.||
0578|041|B|||
0578|042|V|OTHER USES:  This section contains uses of this drug that are not||
0578|043|V|listed in the approved professional labeling for the drug but||
0578|044|V|that may be prescribed by your health care professional. Use this||
0578|045|V|drug for a condition that is listed in this section only if it||
0578|046|V|has been so prescribed by your health care professional.||
0578|047|V|   This drug may also be used for panic disorder or nerve pain||
0578|048|V|(postherpetic neuralgia).||
0578|049|B|||
0578|050|H|HOW TO USE:  Read the Medication Guide provided by your||
0578|051|H|pharmacist before you start taking desipramine and each time you||
0578|052|H|get a refill. If you have any questions, ask your doctor or||
0578|053|H|pharmacist.||
0578|054|H|   Take this medication by mouth with or without food as directed||
0578|055|H|by your doctor, usually 1 to 3 times daily. The dosage is based||
0578|056|H|on your medical condition and response to treatment. Your doctor||
0578|057|H|may start you at a low dose and gradually increase your dose.||
0578|058|H|This medication may make you sleepy or wakeful. Depending on how||
0578|059|H|this medication affects you, your doctor may direct you to take||
0578|060|H|the entire dose once daily either in the morning or at bedtime.||
0578|061|H|   Follow your doctor's instructions carefully. Do not take more||
0578|062|H|or less medication or take it more often than prescribed. Your||
0578|063|H|condition will not improve any faster and your risk of side||
0578|064|H|effects will increase. Use this medication regularly in order to||
0578|065|H|get the most benefit from it. To help you remember, use it at the||
0578|066|H|same time(s) each day.||
0578|067|H|   Keep taking this medication even if you feel well. Do not||
0578|068|H|suddenly stop taking this medication without consulting your||
0578|069|H|doctor. Some conditions may become worse when the drug is||
0578|070|H|abruptly stopped. Your dose may need to be gradually decreased.||
0578|071|H|   This medication does not work right away. It may take 2 to 3||
0578|072|H|weeks before you experience the full benefits when this||
0578|073|H|medication is used for depression.||
0578|074|H|   Tell your doctor if your condition lasts or gets worse.||
0578|075|B|||
0578|076|S|SIDE EFFECTS:  See also Warning section.||
0578|077|S|   Headache, nausea, dizziness, drowsiness, nervousness, trouble||
0578|078|S|sleeping, blurred vision, increased appetite, weight gain,||
0578|079|S|constipation and dry mouth may occur. If any of these effects||
0578|080|S|last or get worse, notify your doctor or pharmacist promptly.||
0578|081|S|   To reduce the risk of dizziness and lightheadedness, get up||
0578|082|S|slowly when rising from a sitting or lying position.||
0578|083|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0578|084|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0578|085|S|substitute.||
0578|086|S|   Remember that this medication has been prescribed because your||
0578|087|S|doctor has judged that the benefit to you is greater than the||
0578|088|S|risk of side effects. Many people using this medication do not||
0578|089|S|have serious side effects.||
0578|090|S|   Tell your doctor right away if you have any serious side||
0578|091|S|effects, including: mental/mood changes (such as confusion,||
0578|092|S|hallucinations, memory problems), enlarged/painful breasts,||
0578|093|S|unusual breast milk production, irregular/painful menstrual||
0578|094|S|periods, ringing in the ears, sexual problems (such as decreased||
0578|095|S|sexual ability, changes in desire), shakiness (tremors),||
0578|096|S|numbness/tingling of the hands/feet, pain/redness/swelling of||
0578|097|S|arms or legs, trouble urinating, easy bruising/bleeding, signs of||
0578|098|S|infection (such as sore throat that doesn't go away, fever,||
0578|099|S|chills), severe stomach/abdominal pain, dark urine, yellowing of||
0578|100|S|eyes/skin.||
0578|101|S|   Get medical help right away if you have any very serious side||
0578|102|S|effects, including: chest pain, slow/fast/irregular heartbeat,||
0578|103|S|seizures, fainting, trouble speaking, weakness on one side of the||
0578|104|S|body, eye pain/swelling/redness, widened pupils, vision changes||
0578|105|S|(such as seeing rainbows around lights at night).||
0578|106|S|   This medication may increase serotonin and rarely cause a very||
0578|107|S|serious condition called serotonin syndrome/toxicity. The risk||
0578|108|S|increases if you are also taking other drugs that increase||
0578|109|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0578|110|S|take (see Drug Interactions section). Get medical help right away||
0578|111|S|if you develop some of the following symptoms: fast heartbeat,||
0578|112|S|hallucinations, loss of coordination, severe dizziness, severe||
0578|113|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0578|114|S|unusual agitation/restlessness.||
0578|115|S|   This drug may rarely cause a serious nervous system disorder||
0578|116|S|(neuroleptic malignant syndrome). Get medical help right away if||
0578|117|S|you notice any of the following very serious side effects: muscle||
0578|118|S|stiffness, high fever, increased sweating, fast heartbeat, sudden||
0578|119|S|mental/mood changes, signs of kidney problems (such as change in||
0578|120|S|the amount of urine).||
0578|121|S|   A very serious allergic reaction to this drug is rare.||
0578|122|S|However, get medical help right away if you notice any symptoms||
0578|123|S|of a serious allergic reaction, including: rash, itching/swelling||
0578|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0578|125|S|breathing.||
0578|126|S|   This is not a complete list of possible side effects. If you||
0578|127|S|notice other effects not listed above, contact your doctor or||
0578|128|S|pharmacist.||
0578|129|S|   In the US -||
0578|130|S|   Call your doctor for medical advice about side effects. You||
0578|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0578|132|S|www.fda.gov/medwatch.||
0578|133|S|   In Canada - Call your doctor for medical advice about side||
0578|134|S|effects. You may report side effects to Health Canada at||
0578|135|S|1-866-234-2345.||
0578|136|B|||
0578|137|P|PRECAUTIONS:  See also Warning section.||
0578|138|P|   Before taking this medication, tell your doctor or pharmacist||
0578|139|P|if you are allergic to it; or to other tricyclic antidepressants||
0578|140|P|(such as imipramine, amitriptyline); or if you have any other||
0578|141|P|allergies. This product may contain inactive ingredients, which||
0578|142|P|can cause allergic reactions or other problems. Talk to your||
0578|143|P|pharmacist for more details.||
0578|144|P|   Before using this medication, tell your doctor or pharmacist||
0578|145|P|your medical history, especially of: breathing problems (such as||
0578|146|P|asthma, chronic bronchitis), personal or family history of||
0578|147|P|glaucoma (angle-closure type), diabetes, eating disorders (such||
0578|148|P|as bulimia), heart problems (such as arrhythmias, coronary artery||
0578|149|P|disease, heart attack), liver problems, kidney problems, personal||
0578|150|P|or family history of other mental/mood conditions (such as||
0578|151|P|bipolar disorder, schizophrenia), seizures, overactive thyroid||
0578|152|P|(hyperthyroidism), trouble urinating (such as due to enlarged||
0578|153|P|prostate), any condition that may increase your risk of seizures||
0578|154|P|(including alcohol/sedative dependency, use of electroconvulsive||
0578|155|P|therapy, brain injury/disease such as stroke), certain types of||
0578|156|P|tumors (such as pheochromocytoma, neuroblastoma).||
0578|157|P|   Desipramine may cause a condition that affects the heart||
0578|158|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0578|159|P|serious (rarely fatal) fast/irregular heartbeat and other||
0578|160|P|symptoms (such as severe dizziness, fainting) that need medical||
0578|161|P|attention right away.||
0578|162|P|   The risk of QT prolongation may be increased if you have||
0578|163|P|certain medical conditions or are taking other drugs that may||
0578|164|P|cause QT prolongation. Before using desipramine, tell your doctor||
0578|165|P|or pharmacist of all the drugs you take and if you have any of||
0578|166|P|the following conditions: certain heart problems (heart failure,||
0578|167|P|slow heartbeat, QT prolongation in the EKG), family history of||
0578|168|P|certain heart problems (QT prolongation in the EKG, sudden||
0578|169|P|cardiac death).||
0578|170|P|   Low levels of potassium or magnesium in the blood may also||
0578|171|P|increase your risk of QT prolongation. This risk may increase if||
0578|172|P|you use certain drugs (such as diuretics/"water pills") or if you||
0578|173|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0578|174|P|Talk to your doctor about using desipramine safely.||
0578|175|P|   Before having surgery, tell your doctor or dentist about all||
0578|176|P|the products you use (including prescription drugs,||
0578|177|P|nonprescription drugs, and herbal products).||
0578|178|P|   This drug may make you dizzy or drowsy or blur your vision.||
0578|179|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0578|180|P|drowsy. Do not drive, use machinery, or do anything that needs||
0578|181|P|alertness or clear vision until you can do it safely. Limit||
0578|182|P|alcoholic beverages. Talk to your doctor if you are using||
0578|183|P|marijuana (cannabis).||
0578|184|P|   This medication may make you more sensitive to the sun. Limit||
0578|185|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0578|186|P|sunscreen and wear protective clothing when outdoors. Tell your||
0578|187|P|doctor right away if you get sunburned or have skin||
0578|188|P|blisters/redness.||
0578|189|P|   If you have diabetes, this drug may make it harder to control||
0578|190|P|your blood sugar. Check your blood sugar regularly as directed||
0578|191|P|and share the results with your doctor. Tell your doctor right||
0578|192|P|away if you have symptoms such as increased thirst/urination.||
0578|193|P|Your doctor may need to adjust your diabetes medication, exercise||
0578|194|P|program, or diet.||
0578|195|P|   Older adults may be more sensitive to the side effects of this||
0578|196|P|drug, especially dizziness (more likely when standing up),||
0578|197|P|drowsiness, constipation, trouble urinating, mental/mood changes||
0578|198|P|(such as confusion, agitation) and heart effects such as QT||
0578|199|P|prolongation (see above). Dizziness, drowsiness, and confusion||
0578|200|P|can increase the risk of falling. Older adults may also be more||
0578|201|P|likely to develop low sodium in the blood, especially if they are||
0578|202|P|taking "water pills" (diuretics).||
0578|203|P|   During pregnancy, this medication should be used only when||
0578|204|P|clearly needed. Infants born to mothers who have taken similar||
0578|205|P|medications during pregnancy may have symptoms such as trouble||
0578|206|P|urinating, prolonged sleepiness, shaking, and seizures. Discuss||
0578|207|P|the risks and benefits with your doctor.||
0578|208|P|   Since untreated mental/mood problems (such as depression,||
0578|209|P|panic disorder) can be a serious condition, do not stop taking||
0578|210|P|this medication unless directed by your doctor. If you are||
0578|211|P|planning pregnancy, become pregnant, or think you may be||
0578|212|P|pregnant, immediately discuss with your doctor the benefits and||
0578|213|P|risks of using this medication during pregnancy.||
0578|214|P|   This drug passes into breast milk and may have undesirable||
0578|215|P|effects on a nursing infant. Consult your doctor before||
0578|216|P|breastfeeding.||
0578|217|B|||
0578|218|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0578|219|I|medications work or increase your risk for serious side effects.||
0578|220|I|This document does not contain all possible drug interactions.||
0578|221|I|Keep a list of all the products you use (including||
0578|222|I|prescription/nonprescription drugs and herbal products) and share||
0578|223|I|it with your doctor and pharmacist. Do not start, stop, or change||
0578|224|I|the dosage of any medicines without your doctor's approval.||
0578|225|I|   Some products that may interact with this drug include:||
0578|226|I|disopyramide, certain drugs for high blood pressure (such as||
0578|227|I|clonidine, guanadrel, guanethidine), digoxin, thyroid||
0578|228|I|supplements, valproic acid.||
0578|229|I|   Taking MAO inhibitors with this medication may cause a serious||
0578|230|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0578|231|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0578|232|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0578|233|I|selegiline, tranylcypromine) during treatment with this||
0578|234|I|medication. Most MAO inhibitors should also not be taken for two||
0578|235|I|weeks before and after treatment with this medication. Ask your||
0578|236|I|doctor when to start or stop taking this medication.||
0578|237|I|   The risk of serotonin syndrome/toxicity increases if you are||
0578|238|I|also taking other drugs that increase serotonin. Examples include||
0578|239|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0578|240|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0578|241|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0578|242|I|serotonin syndrome/toxicity may be more likely when you start or||
0578|243|I|increase the dose of these drugs.||
0578|244|I|   Other medications can affect the removal of desipramine from||
0578|245|I|your body, which may affect how desipramine works. Examples||
0578|246|I|include barbiturates (such as phenobarbital), cimetidine,||
0578|247|I|haloperidol, certain drugs for heart rhythm (such as flecainide,||
0578|248|I|propafenone), HIV protease inhibitors (such as fosamprenavir),||
0578|249|I|phenothiazines (such as thioridazine), pimozide, certain||
0578|250|I|anti-seizure drugs (such as phenytoin), antidepressants (such as||
0578|251|I|trazodone), among others.||
0578|252|I|   Cigarette smoking decreases blood levels of this medication.||
0578|253|I|Tell your doctor if you smoke or if you have recently stopped||
0578|254|I|smoking.||
0578|255|I|   Many drugs besides desipramine may affect the heart rhythm (QT||
0578|256|I|prolongation in the EKG), including amiodarone, dofetilide,||
0578|257|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
0578|258|I|(such as erythromycin), among others. Before using desipramine,||
0578|259|I|report all medications you are currently using to your doctor or||
0578|260|I|pharmacist.||
0578|261|I|   Tell your doctor or pharmacist if you are taking other||
0578|262|I|products that cause drowsiness including alcohol, marijuana||
0578|263|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0578|264|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0578|265|I|zolpidem), muscle relaxants (such as carisoprodol,||
0578|266|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
0578|267|I|hydrocodone).||
0578|268|I|   Check the labels on all your medicines (such as allergy or||
0578|269|I|cough-and-cold products) because they may contain ingredients||
0578|270|I|that cause drowsiness. Ask your pharmacist about using those||
0578|271|I|products safely.||
0578|272|I|   Desipramine is very similar to imipramine. Do not take||
0578|273|I|medications containing imipramine while using desipramine.||
0578|274|B|||
0578|275|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0578|276|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0578|277|O|poison control center right away. US residents can call||
0578|278|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0578|279|O|Symptoms of overdose may include: severe dizziness,||
0578|280|O|fast/irregular heartbeat, fainting, hallucinations, seizures.||
0578|281|B|||
0578|282|N|NOTES:  Do not share this medication with others.||
0578|283|N|   Lab and/or medical tests (such as blood count, EKG, kidney||
0578|284|N|function) may be done while you are taking this medication. Keep||
0578|285|N|all medical and lab appointments. Consult your doctor for more||
0578|286|N|details.||
0578|287|B|||
0578|288|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0578|289|D|remember. If it is near the time of the next dose, skip the||
0578|290|D|missed dose. Take your next dose at the regular time. Do not||
0578|291|D|double the dose to catch up.||
0578|292|B|||
0578|293|R|STORAGE:  Store at room temperature away from light and moisture.||
0578|294|R|Do not store in the bathroom. Keep all medications away from||
0578|295|R|children and pets.||
0578|296|R|   Do not flush medications down the toilet or pour them into a||
0578|297|R|drain unless instructed to do so. Properly discard this product||
0578|298|R|when it is expired or no longer needed. Consult your pharmacist||
0578|299|R|or local waste disposal company.||
0578|300|B|||
0578|301|A|Information last revised June 2025.||
0578|302|A|Copyright(c) 2025 First Databank, Inc.||
0578|303|B|||
0579|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0579|002|Z|does NOT have all possible information about this product. This||
0579|003|Z|information does not assure that this product is safe, effective,||
0579|004|Z|or appropriate for you. This information is not individual||
0579|005|Z|medical advice and does not substitute for the advice of your||
0579|006|Z|health care professional. Always ask your health care||
0579|007|Z|professional for complete information about this product and your||
0579|008|Z|specific health needs.||
0579|009|B|||
0579|010|T|LEVALBUTEROL HFA INHALER - ORAL INHALATION||
0579|011|F|(LEV-al-BUE-ter-ol)||
0579|012|B|||
0579|013|C|COMMON BRAND NAME(S): Xopenex HFA||
0579|014|B|||
0579|015|U|USES:  Levalbuterol is used to prevent and treat wheezing and||
0579|016|U|shortness of breath caused by breathing problems (such as asthma,||
0579|017|U|chronic obstructive pulmonary disease). It is a quick-relief||
0579|018|U|drug. Levalbuterol belongs to a class of drugs known as||
0579|019|U|bronchodilators. It works by relaxing the muscles around the||
0579|020|U|airways so that they open up and you can breathe more easily.||
0579|021|U|Controlling symptoms of breathing problems can decrease time lost||
0579|022|U|from work or school.||
0579|023|U|   This drug is not approved for use in children younger than 4||
0579|024|U|years due to increased risk of side effects (such as unusual fast||
0579|025|U|breathing, worsening asthma). Ask your doctor or pharmacist for||
0579|026|U|details.||
0579|027|B|||
0579|028|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0579|029|H|your pharmacist before you start using this medication and each||
0579|030|H|time you get a refill. Follow the illustrated directions for the||
0579|031|H|proper use of this medication and proper cleaning of the||
0579|032|H|mouthpiece. If you have any questions, ask your doctor or||
0579|033|H|pharmacist.||
0579|034|H|   Shake the canister well before using. Follow the instructions||
0579|035|H|for test sprays in the air if you are using a canister for the||
0579|036|H|first time or if you have not used it for 3 days or more. A fine||
0579|037|H|mist is a sign that the inhaler is working properly. Avoid||
0579|038|H|spraying the medication in your eyes.||
0579|039|H|   Inhale this medication by mouth as directed by your doctor,||
0579|040|H|usually every 4 to 6 hours as needed. If two inhalations are||
0579|041|H|prescribed, wait at least 1 minute between them. The dosage is||
0579|042|H|based on your medical condition and response to treatment. Do not||
0579|043|H|increase your dose or use this drug more often than prescribed||
0579|044|H|without your doctor's approval. Using too much of this medication||
0579|045|H|will increase your risk of serious (possibly fatal) side effects.||
0579|046|H|   Using a spacer device with the inhaler may help you use this||
0579|047|H|medication properly. Ask your doctor or pharmacist for more||
0579|048|H|information.||
0579|049|H|   If a child is using this medication, a parent or other||
0579|050|H|responsible adult may need to help the child use the inhaler||
0579|051|H|properly.||
0579|052|H|   If you are using other inhalers at the same time, wait at||
0579|053|H|least 1 minute between the use of each medication.||
0579|054|H|   Always have this quick-relief inhaler with you. Keep track of||
0579|055|H|the number of inhalations you use, and discard the inhaler after||
0579|056|H|you have used the labeled number of inhalations on the product||
0579|057|H|package. Also count test sprays used to prime the inhaler. Do not||
0579|058|H|float the metal canister in water to test if any more drug is||
0579|059|H|left in the canister.||
0579|060|H|   Learn which of your inhalers you should use every day||
0579|061|H|(controller drugs) and which you should use if your breathing||
0579|062|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
0579|063|H|time what you should do if you have new or worsening cough or||
0579|064|H|shortness of breath, wheezing, increased sputum, worsening peak||
0579|065|H|flow meter readings, waking up at night with trouble breathing,||
0579|066|H|if you use your quick-relief inhaler more often (more than 2 days||
0579|067|H|a week), or if your quick-relief inhaler does not seem to be||
0579|068|H|working well. Learn when you can treat sudden breathing problems||
0579|069|H|by yourself and when you must get medical help right away.||
0579|070|H|   Tell your doctor if your symptoms do not get better or if they||
0579|071|H|get worse.||
0579|072|B|||
0579|073|S|SIDE EFFECTS:  Nervousness, dizziness, shaking (tremor), trouble||
0579|074|S|sleeping, headache, nausea, dry mouth, cough, sore throat, or||
0579|075|S|runny nose may occur. If any of these effects last or get worse,||
0579|076|S|tell your doctor or pharmacist promptly.||
0579|077|S|   Remember that this medication has been prescribed because your||
0579|078|S|doctor has judged that the benefit to you is greater than the||
0579|079|S|risk of side effects. Many people using this medication do not||
0579|080|S|have serious side effects.||
0579|081|S|   This medication may raise your blood pressure. Check your||
0579|082|S|blood pressure regularly and tell your doctor if the results are||
0579|083|S|high.||
0579|084|S|   Tell your doctor right away if you have any serious side||
0579|085|S|effects, including: fast/pounding heartbeat.||
0579|086|S|   Get medical help right away if you have any very serious side||
0579|087|S|effects, including: chest pain, irregular heartbeat, rapid||
0579|088|S|breathing, confusion.||
0579|089|S|   Rarely, this medication has caused severe (rarely fatal),||
0579|090|S|sudden worsening of breathing problems/asthma (paradoxical||
0579|091|S|bronchospasm). If you experience sudden wheezing, get medical||
0579|092|S|help right away.||
0579|093|S|   A very serious allergic reaction to this drug is rare.||
0579|094|S|However, get medical help right away if you notice any symptoms||
0579|095|S|of a serious allergic reaction, including: rash, itching/swelling||
0579|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0579|097|S|breathing.||
0579|098|S|   This is not a complete list of possible side effects. If you||
0579|099|S|notice other effects not listed above, contact your doctor or||
0579|100|S|pharmacist.||
0579|101|S|   In the US -||
0579|102|S|   Call your doctor for medical advice about side effects. You||
0579|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0579|104|S|www.fda.gov/medwatch.||
0579|105|S|   In Canada - Call your doctor for medical advice about side||
0579|106|S|effects. You may report side effects to Health Canada at||
0579|107|S|1-866-234-2345.||
0579|108|B|||
0579|109|P|PRECAUTIONS:  Before taking levalbuterol, tell your doctor or||
0579|110|P|pharmacist if you are allergic to it; or to similar drugs (such||
0579|111|P|as albuterol, metaproterenol, salmeterol); or if you have any||
0579|112|P|other allergies. This product may contain inactive ingredients,||
0579|113|P|which can cause allergic reactions or other problems. Talk to||
0579|114|P|your pharmacist for more details.||
0579|115|P|   Before using this medication, tell your doctor or pharmacist||
0579|116|P|your medical history, especially of: heart problems (such as||
0579|117|P|irregular heartbeat, angina, previous heart attack), high blood||
0579|118|P|pressure, kidney disease, seizure.||
0579|119|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0579|120|P|can make you more dizzy. Do not drive, use machinery, or do||
0579|121|P|anything that needs alertness until you can do it safely. Limit||
0579|122|P|alcoholic beverages. Talk to your doctor if you are using||
0579|123|P|marijuana (cannabis).||
0579|124|P|   Before having surgery, tell your doctor or dentist about all||
0579|125|P|the products you use (including prescription drugs,||
0579|126|P|nonprescription drugs, and herbal products).||
0579|127|P|   During pregnancy, this medication should be used only when||
0579|128|P|clearly needed. Discuss the risks and benefits with your doctor.||
0579|129|P|   It is unknown if this drug passes into breast milk. Consult||
0579|130|P|your doctor before breastfeeding.||
0579|131|B|||
0579|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0579|133|I|medications work or increase your risk for serious side effects.||
0579|134|I|This document does not contain all possible drug interactions.||
0579|135|I|Keep a list of all the products you use (including||
0579|136|I|prescription/nonprescription drugs and herbal products) and share||
0579|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
0579|138|I|the dosage of any medicines without your doctor's approval.||
0579|139|I|   Levalbuterol is very similar to albuterol. Do not use inhaled||
0579|140|I|medications containing albuterol while using levalbuterol.||
0579|141|B|||
0579|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0579|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0579|144|O|poison control center right away. US residents can call||
0579|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0579|146|O|Symptoms of overdose may include: chest pain,||
0579|147|O|fast/pounding/irregular heartbeat, headache, shaking (tremors),||
0579|148|O|nervousness, weakness, severe dizziness, seizures.||
0579|149|B|||
0579|150|N|NOTES:  Do not share this medication with others.||
0579|151|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
0579|152|N|EKG) may be done while you are using this medication. Keep all||
0579|153|N|medical and lab appointments. Consult your doctor for more||
0579|154|N|details.||
0579|155|N|   Avoid allergens/irritants that can worsen breathing problems,||
0579|156|N|such as smoke, pollen, pet dander, dust, or molds.||
0579|157|N|   Learn to use a peak flow meter, use it daily, and promptly||
0579|158|N|report worsening breathing problems (such as readings in the||
0579|159|N|yellow/red range, increased use of quick-relief inhalers).||
0579|160|N|   Because the flu virus can worsen breathing problems, ask your||
0579|161|N|doctor or pharmacist if you should have a flu shot every year.||
0579|162|B|||
0579|163|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0579|164|D|If it is near the time of the next dose, skip the missed dose.||
0579|165|D|Use your next dose at the regular time. Do not double the dose to||
0579|166|D|catch up.||
0579|167|B|||
0579|168|R|STORAGE:  Store at room temperature away from direct sunlight. It||
0579|169|R|is best to store the inhaler with the mouthpiece down. Do not||
0579|170|R|freeze. Do not puncture the canister or expose it to high heat or||
0579|171|R|open flame. Keep all medications away from children and pets.||
0579|172|R|   Do not flush medications down the toilet or pour them into a||
0579|173|R|drain unless instructed to do so. Properly discard this product||
0579|174|R|when it is expired or no longer needed. Consult your pharmacist||
0579|175|R|or local waste disposal company.||
0579|176|B|||
0579|177|M|MEDICAL ALERT:  Your condition can cause complications in a||
0579|178|M|medical emergency. For information about enrolling in MedicAlert,||
0579|179|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0579|180|B|||
0579|181|A|Information last revised October 2024.||
0579|182|A|Copyright(c) 2025 First Databank, Inc.||
0579|183|B|||
0580|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0580|002|Z|does NOT have all possible information about this product. This||
0580|003|Z|information does not assure that this product is safe, effective,||
0580|004|Z|or appropriate for you. This information is not individual||
0580|005|Z|medical advice and does not substitute for the advice of your||
0580|006|Z|health care professional. Always ask your health care||
0580|007|Z|professional for complete information about this product and your||
0580|008|Z|specific health needs.||
0580|009|B|||
0580|010|T|SORAFENIB - ORAL||
0580|011|F|(soe-RAF-e-nib)||
0580|012|B|||
0580|013|C|COMMON BRAND NAME(S): Nexavar||
0580|014|B|||
0580|015|U|USES:  Sorafenib is used to treat kidney, liver, and thyroid||
0580|016|U|cancer. It works by slowing or stopping the growth of cancer||
0580|017|U|cells.||
0580|018|B|||
0580|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0580|020|H|from your pharmacist before you start taking sorafenib and each||
0580|021|H|time you get a refill. If you have any questions, ask your doctor||
0580|022|H|or pharmacist.||
0580|023|H|   Take this medication by mouth on an empty stomach (at least 1||
0580|024|H|hour before or 2 hours after a meal) as directed by your doctor,||
0580|025|H|usually twice a day.||
0580|026|H|   The dosage is based on your medical condition and response to||
0580|027|H|treatment. Do not increase your dose or use this drug more often||
0580|028|H|or for longer than prescribed. Your condition will not improve||
0580|029|H|any faster, and your risk of serious side effects will increase.||
0580|030|H|   Use this medication regularly to get the most benefit from it.||
0580|031|H|To help you remember, take it at the same times each day.||
0580|032|H|   Since this drug can be absorbed through the skin and lungs and||
0580|033|H|may harm an unborn baby, women who are pregnant or who may become||
0580|034|H|pregnant should not handle this medication or breathe the dust||
0580|035|H|from the tablets.||
0580|036|B|||
0580|037|S|SIDE EFFECTS:  Weight loss, nausea/vomiting, diarrhea, loss of||
0580|038|S|appetite, changes in taste, dry skin, mouth sores, hair loss,||
0580|039|S|voice changes, or tiredness may occur. If any of these effects||
0580|040|S|last or get worse, tell your doctor or pharmacist promptly.||
0580|041|S|   People using this medication may have serious side effects.||
0580|042|S|However, you have been prescribed this drug because your doctor||
0580|043|S|has judged that the benefit to you is greater than the risk of||
0580|044|S|side effects. Careful monitoring by your doctor may decrease your||
0580|045|S|risk.||
0580|046|S|   This medication may raise your blood pressure. Check your||
0580|047|S|blood pressure regularly and tell your doctor if the results are||
0580|048|S|high. Your doctor may control your blood pressure with||
0580|049|S|medication.||
0580|050|S|   Treatment with this drug may sometimes cause your hands/feet||
0580|051|S|to develop a skin reaction called hand-foot syndrome. Tell your||
0580|052|S|doctor right away if you experience swelling, pain, redness,||
0580|053|S|blisters, or tingling/burning of the hands/feet. Depending on how||
0580|054|S|severe your hand-foot syndrome is, your doctor may give you an||
0580|055|S|additional medication to reduce the symptoms, or may stop or||
0580|056|S|delay your sorafenib treatment.||
0580|057|S|   This medication can affect how your thyroid works. Tell your||
0580|058|S|doctor right away if you have signs of an underactive thyroid||
0580|059|S|(such as weight gain, cold intolerance, slow heartbeat,||
0580|060|S|constipation, or unusual tiredness) or signs of an overactive||
0580|061|S|thyroid (such as mental/mood changes, heat intolerance, unusual||
0580|062|S|weight loss).||
0580|063|S|   Tell your doctor right away if you have any serious side||
0580|064|S|effects, including: easy bruising/bleeding, signs of liver||
0580|065|S|disease (such as nausea/vomiting that doesn't stop,||
0580|066|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
0580|067|S|numb/tingling skin, slow wound healing, muscle spasms, signs of||
0580|068|S|infection (such as sore throat that doesn't go away, fever,||
0580|069|S|chills), signs of heart failure (such as shortness of breath,||
0580|070|S|swelling ankles/feet, unusual tiredness).||
0580|071|S|   Get medical help right away if you have any very serious side||
0580|072|S|effects, including: chest/jaw/left arm pain, unusual sweating,||
0580|073|S|fast/irregular heartbeat, severe dizziness, fainting, vomit that||
0580|074|S|looks like coffee grounds, black/bloody stools, sudden/severe||
0580|075|S|back pain or headache, weakness on one side of the body, sudden||
0580|076|S|vision changes, trouble speaking, confusion.||
0580|077|S|   Sorafenib can commonly cause a rash that is usually not||
0580|078|S|serious. However, you may not be able to tell it apart from a||
0580|079|S|rare rash that could be a sign of a severe reaction. Get medical||
0580|080|S|help right away if you develop any rash.||
0580|081|S|   A very serious allergic reaction to this drug is rare.||
0580|082|S|However, get medical help right away if you notice any symptoms||
0580|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0580|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0580|085|S|breathing.||
0580|086|S|   This is not a complete list of possible side effects. If you||
0580|087|S|notice other effects not listed above, contact your doctor or||
0580|088|S|pharmacist.||
0580|089|S|   In the US -||
0580|090|S|   Call your doctor for medical advice about side effects. You||
0580|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0580|092|S|www.fda.gov/medwatch.||
0580|093|S|   In Canada - Call your doctor for medical advice about side||
0580|094|S|effects. You may report side effects to Health Canada at||
0580|095|S|1-866-234-2345.||
0580|096|B|||
0580|097|P|PRECAUTIONS:  Before taking sorafenib, tell your doctor or||
0580|098|P|pharmacist if you are allergic to it; or if you have any other||
0580|099|P|allergies. This product may contain inactive ingredients, which||
0580|100|P|can cause allergic reactions or other problems. Talk to your||
0580|101|P|pharmacist for more details.||
0580|102|P|   Before using this medication, tell your doctor or pharmacist||
0580|103|P|your medical history, especially of: bleeding problems, recent||
0580|104|P|surgery/injury, heart disease (such as heart attack, coronary||
0580|105|P|artery disease), high blood pressure, blood vessel problems (such||
0580|106|P|as an aneurysm or a tear/break in the aorta or other blood||
0580|107|P|vessels), liver disease.||
0580|108|P|   Sorafenib may cause a condition that affects the heart rhythm||
0580|109|P|(QT prolongation). QT prolongation can rarely cause serious||
0580|110|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0580|111|P|as severe dizziness, fainting) that need medical attention right||
0580|112|P|away.||
0580|113|P|   The risk of QT prolongation may be increased if you have||
0580|114|P|certain medical conditions or are taking other drugs that may||
0580|115|P|cause QT prolongation. Before using sorafenib, tell your doctor||
0580|116|P|or pharmacist of all the drugs you take and if you have any of||
0580|117|P|the following conditions: certain heart problems (heart failure,||
0580|118|P|slow heartbeat, QT prolongation in the EKG), family history of||
0580|119|P|certain heart problems (QT prolongation in the EKG, sudden||
0580|120|P|cardiac death).||
0580|121|P|   Low levels of potassium or magnesium in the blood may also||
0580|122|P|increase your risk of QT prolongation. This risk may increase if||
0580|123|P|you use certain drugs (such as diuretics/"water pills") or if you||
0580|124|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0580|125|P|Talk to your doctor about using sorafenib safely.||
0580|126|P|   Before having surgery, tell your doctor or dentist about all||
0580|127|P|the products you use (including prescription drugs,||
0580|128|P|nonprescription drugs, and herbal products).||
0580|129|P|   This medication may cause wounds to heal slowly or poorly.||
0580|130|P|Before having surgery, talk with your doctor about the risks and||
0580|131|P|benefits of this medication. Your doctor may tell you to||
0580|132|P|temporarily stop treatment with this medication at least 10 days||
0580|133|P|before surgery. Ask your doctor for specific instructions about||
0580|134|P|when to stop and when to restart treatment with sorafenib. Tell||
0580|135|P|your doctor right away if you have wounds that are not healing||
0580|136|P|well.||
0580|137|P|   Older adults may be more sensitive to the side effects of this||
0580|138|P|drug, especially QT prolongation (see above).||
0580|139|P|   Since this drug can be absorbed through the skin and lungs and||
0580|140|P|may harm an unborn baby, women who are pregnant or who may become||
0580|141|P|pregnant should not handle this medication or breathe the dust||
0580|142|P|from the tablets.||
0580|143|P|   Tell your doctor if you are pregnant or plan to become||
0580|144|P|pregnant. You should not become pregnant while using sorafenib.||
0580|145|P|Sorafenib may harm an unborn baby. Your doctor should order a||
0580|146|P|pregnancy test before you start this medication. Women using this||
0580|147|P|medication should ask about reliable forms of birth control||
0580|148|P|during treatment and for 6 months after the last dose. Men using||
0580|149|P|this medication should ask about reliable forms of birth control||
0580|150|P|during treatment and for 3 months after the last dose. If you or||
0580|151|P|your partner becomes pregnant, talk to your doctor right away||
0580|152|P|about the risks and benefits of this medication.||
0580|153|P|   It is unknown if this drug passes into breast milk. Because of||
0580|154|P|the possible risk to the infant, breastfeeding is not recommended||
0580|155|P|while using this drug and for 2 weeks after the last dose.||
0580|156|P|Consult your doctor before breastfeeding.||
0580|157|B|||
0580|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0580|159|I|medications work or increase your risk for serious side effects.||
0580|160|I|This document does not contain all possible drug interactions.||
0580|161|I|Keep a list of all the products you use (including||
0580|162|I|prescription/nonprescription drugs and herbal products) and share||
0580|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
0580|164|I|the dosage of any medicines without your doctor's approval.||
0580|165|I|   A product that may interact with this drug is: irinotecan.||
0580|166|I|   Other medications can affect the removal of sorafenib from||
0580|167|I|your body, which may affect how sorafenib works. Examples include||
0580|168|I|neomycin, rifamycins (such as rifampin, rifabutin), St. John's||
0580|169|I|wort, drugs used to treat seizures (such as carbamazepine,||
0580|170|I|phenytoin), among others.||
0580|171|B|||
0580|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0580|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0580|174|O|poison control center right away. US residents can call||
0580|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0580|176|B|||
0580|177|N|NOTES:  Do not share this medication with others.||
0580|178|N|   Lab and/or medical tests (such as blood pressure,||
0580|179|N|liver/thyroid function, complete blood count) should be done||
0580|180|N|while you are taking this medication. Keep all medical and lab||
0580|181|N|appointments. Consult your doctor for more details.||
0580|182|B|||
0580|183|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0580|184|D|remember. If it is near the time of the next dose, skip the||
0580|185|D|missed dose. Take your next dose at the regular time. Do not||
0580|186|D|double the dose to catch up.||
0580|187|B|||
0580|188|R|STORAGE:  Store at room temperature away from light and moisture.||
0580|189|R|Do not store in the bathroom. Keep all medications away from||
0580|190|R|children and pets.||
0580|191|R|   Do not flush medications down the toilet or pour them into a||
0580|192|R|drain unless instructed to do so. Properly discard this product||
0580|193|R|when it is expired or no longer needed. Consult your pharmacist||
0580|194|R|or local waste disposal company.||
0580|195|B|||
0580|196|M|MEDICAL ALERT:  Your condition can cause complications in a||
0580|197|M|medical emergency. For information about enrolling in MedicAlert,||
0580|198|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0580|199|B|||
0580|200|A|Information last revised April 2025.||
0580|201|A|Copyright(c) 2025 First Databank, Inc.||
0580|202|B|||
0581|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0581|002|Z|does NOT have all possible information about this product. This||
0581|003|Z|information does not assure that this product is safe, effective,||
0581|004|Z|or appropriate for you. This information is not individual||
0581|005|Z|medical advice and does not substitute for the advice of your||
0581|006|Z|health care professional. Always ask your health care||
0581|007|Z|professional for complete information about this product and your||
0581|008|Z|specific health needs.||
0581|009|B|||
0581|010|T|HYDROCORTISONE - ORAL||
0581|011|F|(HYE-droe-KOR-ti-sone)||
0581|012|B|||
0581|013|C|COMMON BRAND NAME(S): Cortef||
0581|014|B|||
0581|015|U|USES:  Hydrocortisone is a man-made version of a natural||
0581|016|U|substance (cortisol) made by the adrenal gland. It is used to||
0581|017|U|treat conditions such as arthritis, blood/hormone/immune system||
0581|018|U|disorders, skin and eye conditions, breathing problems, cancer,||
0581|019|U|and severe allergies. It decreases your immune system's response||
0581|020|U|to various diseases to reduce symptoms such as pain, swelling and||
0581|021|U|allergic-type reactions.||
0581|022|U|   Hydrocortisone is also used to treat low cortisol levels||
0581|023|U|caused by diseases of the adrenal gland (such as Addison's||
0581|024|U|disease, adrenocortical insufficiency). Corticosteroids are||
0581|025|U|needed in many ways for the body to function well. They are||
0581|026|U|important for salt and water balance and keeping blood pressure||
0581|027|U|normal.||
0581|028|B|||
0581|029|V|OTHER USES:  This section contains uses of this drug that are not||
0581|030|V|listed in the approved professional labeling for the drug but||
0581|031|V|that may be prescribed by your health care professional. Use this||
0581|032|V|drug for a condition that is listed in this section only if it||
0581|033|V|has been so prescribed by your health care professional.||
0581|034|V|   Hydrocortisone may also be used for COVID-19, but is only||
0581|035|V|effective in hospitalized patients who need supplemental oxygen||
0581|036|V|or a mechanical ventilator to breathe.||
0581|037|B|||
0581|038|H|HOW TO USE:  Take this medication by mouth, with food or milk to||
0581|039|H|prevent stomach upset, exactly as directed by your doctor. Take||
0581|040|H|this medication with a full glass of water (8 ounces/240||
0581|041|H|milliliters) unless your doctor directs you otherwise.||
0581|042|H|   Follow the dosing schedule carefully. The dosage and length of||
0581|043|H|treatment are based on your medical condition and response to||
0581|044|H|treatment. Your doctor may direct you to take hydrocortisone 1 to||
0581|045|H|4 times a day or take a single dose every other day. It may help||
0581|046|H|to mark your calendar with a reminder.||
0581|047|H|   Do not stop taking this medication without consulting your||
0581|048|H|doctor. Some conditions may become worse when this drug is||
0581|049|H|suddenly stopped. Your dose may need to be gradually decreased.||
0581|050|H|   If you suddenly stop using this medication, you may have||
0581|051|H|withdrawal symptoms (such as weakness, weight loss, nausea,||
0581|052|H|muscle pain, headache, tiredness, dizziness). To help prevent||
0581|053|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0581|054|H|more likely if you have used hydrocortisone for a long time or in||
0581|055|H|high doses. Tell your doctor or pharmacist right away if you have||
0581|056|H|withdrawal. See also Precautions section.||
0581|057|H|   Tell your doctor if your condition lasts or gets worse.||
0581|058|B|||
0581|059|S|SIDE EFFECTS:  Nausea, heartburn, headache, trouble sleeping,||
0581|060|S|increased sweating, or acne may occur. If any of these effects||
0581|061|S|last or get worse, tell your doctor or pharmacist promptly.||
0581|062|S|   Remember that this medication has been prescribed because your||
0581|063|S|doctor has judged that the benefit to you is greater than the||
0581|064|S|risk of side effects. Many people using this medication do not||
0581|065|S|have serious side effects.||
0581|066|S|   This medication may rarely make your blood sugar rise, which||
0581|067|S|can cause or worsen diabetes. Tell your doctor right away if you||
0581|068|S|have symptoms of high blood sugar such as increased||
0581|069|S|thirst/urination. If you already have diabetes, check your blood||
0581|070|S|sugar regularly as directed and share the results with your||
0581|071|S|doctor. Your doctor may need to adjust your diabetes medication,||
0581|072|S|exercise program, or diet.||
0581|073|S|   Tell your doctor right away if you have any serious side||
0581|074|S|effects, including: signs of infection (such as sore throat that||
0581|075|S|doesn't go away, fever, chills), weakness, swelling ankles/feet,||
0581|076|S|unusual weight gain, vision problems, easy bruising/bleeding,||
0581|077|S|puffy face, mental/mood changes (such as depression, mood swings,||
0581|078|S|agitation), muscle weakness/pain, thinning skin, slow wound||
0581|079|S|healing, menstrual period changes, irregular heartbeat, bone||
0581|080|S|pain, seizures, symptoms of stomach/intestinal bleeding (such as||
0581|081|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
0581|082|S|coffee grounds), red/purple spots on the skin.||
0581|083|S|   A very serious allergic reaction to this drug is rare.||
0581|084|S|However, get medical help right away if you notice any symptoms||
0581|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0581|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0581|087|S|breathing.||
0581|088|S|   This is not a complete list of possible side effects. If you||
0581|089|S|notice other effects not listed above, contact your doctor or||
0581|090|S|pharmacist.||
0581|091|S|   In the US -||
0581|092|S|   Call your doctor for medical advice about side effects. You||
0581|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0581|094|S|www.fda.gov/medwatch.||
0581|095|S|   In Canada - Call your doctor for medical advice about side||
0581|096|S|effects. You may report side effects to Health Canada at||
0581|097|S|1-866-234-2345.||
0581|098|B|||
0581|099|P|PRECAUTIONS:  Before taking hydrocortisone, tell your doctor or||
0581|100|P|pharmacist if you are allergic to it; or if you have any other||
0581|101|P|allergies. This product may contain inactive ingredients, which||
0581|102|P|can cause allergic reactions or other problems. Talk to your||
0581|103|P|pharmacist for more details.||
0581|104|P|   Before using this medication, tell your doctor or pharmacist||
0581|105|P|your medical history, especially of: eye disease (such as||
0581|106|P|cataracts, glaucoma), heart problems (such as heart failure,||
0581|107|P|recent heart attack), high blood pressure, liver disease (such as||
0581|108|P|hepatitis B), kidney disease, thyroid problems, diabetes,||
0581|109|P|stomach/intestinal problems (such as diverticulitis, ulcer),||
0581|110|P|brittle bones (osteoporosis), current/past infections (such as||
0581|111|P|tuberculosis, positive tuberculosis test, herpes, fungal),||
0581|112|P|bleeding problems, blood clots, mental/mood conditions (such as||
0581|113|P|psychosis, anxiety, depression), low salts in the blood (such as||
0581|114|P|low potassium or calcium), seizures, a certain adrenal gland||
0581|115|P|tumor (pheochromocytoma).||
0581|116|P|   This medication may cause stomach bleeding. Daily use of||
0581|117|P|alcohol while using this medication may increase your risk for||
0581|118|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
0581|119|P|or pharmacist for more information.||
0581|120|P|   Before having surgery, tell your doctor or dentist about all||
0581|121|P|the products you use (including prescription drugs,||
0581|122|P|nonprescription drugs, and herbal products).||
0581|123|P|   Using corticosteroid medications for a long time can make it||
0581|124|P|more difficult for your body to respond to physical stress.||
0581|125|P|Before having surgery or emergency treatment, or if you get a||
0581|126|P|serious illness/injury, tell your doctor or dentist that you are||
0581|127|P|using this medication or have used this medication within the||
0581|128|P|past 12 months. Tell your doctor right away if you develop||
0581|129|P|unusual/extreme tiredness or weight loss. If you will be using||
0581|130|P|this medication for a long time, carry a warning card or medical||
0581|131|P|ID bracelet that identifies your use of this medication.||
0581|132|P|   This medication may mask signs of infection. It can make you||
0581|133|P|more likely to get infections or may make current infections||
0581|134|P|worse. Stay away from anyone who has an infection that may easily||
0581|135|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0581|136|P|doctor if you have been exposed to an infection or for more||
0581|137|P|details.||
0581|138|P|   Tell your health care professional that you are using||
0581|139|P|hydrocortisone before having any immunizations/vaccinations.||
0581|140|P|Avoid contact with people who have recently received live||
0581|141|P|vaccines (such as flu vaccine inhaled through the nose).||
0581|142|P|   This medication may slow down a child's growth if used for a||
0581|143|P|long time. Consult the doctor or pharmacist for more details. See||
0581|144|P|the doctor regularly so your child's height and growth can be||
0581|145|P|checked.||
0581|146|P|   Older adults may be more sensitive to the effects of this||
0581|147|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
0581|148|P|mental/mood changes (such as confusion).||
0581|149|P|   During pregnancy, hydrocortisone should be used only when||
0581|150|P|clearly needed. Discuss the risks and benefits with your doctor.||
0581|151|P|Infants born to mothers who have been using this medication for||
0581|152|P|an extended period of time may have hormone problems. Tell your||
0581|153|P|doctor right away if you notice symptoms such as nausea/vomiting||
0581|154|P|that doesn't stop, severe diarrhea, or weakness in your newborn.||
0581|155|P|   It is unknown if this drug passes into breast milk. However,||
0581|156|P|this drug is unlikely to harm a nursing infant. Consult your||
0581|157|P|doctor before breastfeeding.||
0581|158|B|||
0581|159|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0581|160|I|medications work or increase your risk for serious side effects.||
0581|161|I|This document does not contain all possible drug interactions.||
0581|162|I|Keep a list of all the products you use (including||
0581|163|I|prescription/nonprescription drugs and herbal products) and share||
0581|164|I|it with your doctor and pharmacist. Do not start, stop, or change||
0581|165|I|the dosage of any medicines without your doctor's approval.||
0581|166|I|   Some products that may interact with this drug include:||
0581|167|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
0581|168|I|cause bleeding/bruising (such as antiplatelet drugs like||
0581|169|I|clopidogrel, NSAIDs like ibuprofen/naproxen, "blood thinners"||
0581|170|I|like warfarin/dabigatran).||
0581|171|I|   Aspirin can increase the risk of bleeding when used with this||
0581|172|I|medication. However, if your doctor has told you to take low-dose||
0581|173|I|aspirin to prevent heart attack or stroke (usually 81-162||
0581|174|I|milligrams a day), you should keep taking the aspirin unless your||
0581|175|I|doctor tells you not to. Ask your doctor or pharmacist for more||
0581|176|I|details.||
0581|177|I|   This medication may interfere with certain lab tests (such as||
0581|178|I|skin tests), possibly causing false test results. Make sure lab||
0581|179|I|personnel and all your doctors know you use this drug.||
0581|180|B|||
0581|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0581|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0581|183|O|poison control center right away. US residents can call||
0581|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0581|185|B|||
0581|186|N|NOTES:  Do not share this medication with others.||
0581|187|N|   If this medication is used for a long time, lab and/or medical||
0581|188|N|tests (such as blood sugar/mineral levels, blood counts, blood||
0581|189|N|pressure, bone density tests, eye exams, height/weight||
0581|190|N|measurements, X-rays) should be done while you are taking this||
0581|191|N|medication. Keep all medical and lab appointments. Consult your||
0581|192|N|doctor for more details.||
0581|193|N|   This medication may cause bone loss (osteoporosis) when used||
0581|194|N|for a long time. Lifestyle changes that may help reduce the risk||
0581|195|N|of bone problems include doing weight-bearing exercise, stopping||
0581|196|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
0581|197|N|D. Talk to your doctor for more details.||
0581|198|B|||
0581|199|D|MISSED DOSE:  If you are taking this medication once daily and||
0581|200|D|miss a dose, take it as soon as you remember. If it is near the||
0581|201|D|time of the next dose, skip the missed dose. Take your next dose||
0581|202|D|at the regular time. If you are taking this medication every||
0581|203|D|other day, ask your doctor or pharmacist what you should do if||
0581|204|D|you miss a dose.||
0581|205|B|||
0581|206|R|STORAGE:  Store at room temperature away from light and moisture.||
0581|207|R|Do not store in the bathroom. Keep all medications away from||
0581|208|R|children and pets.||
0581|209|R|   Do not flush medications down the toilet or pour them into a||
0581|210|R|drain unless instructed to do so. Properly discard this product||
0581|211|R|when it is expired or no longer needed. Consult your pharmacist||
0581|212|R|or local waste disposal company.||
0581|213|B|||
0581|214|M|MEDICAL ALERT:  Your condition can cause complications in a||
0581|215|M|medical emergency. For information about enrolling in MedicAlert,||
0581|216|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0581|217|B|||
0581|218|A|Information last revised September 2025.||
0581|219|A|Copyright(c) 2025 First Databank, Inc.||
0581|220|B|||
0583|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0583|002|Z|does NOT have all possible information about this product. This||
0583|003|Z|information does not assure that this product is safe, effective,||
0583|004|Z|or appropriate for you. This information is not individual||
0583|005|Z|medical advice and does not substitute for the advice of your||
0583|006|Z|health care professional. Always ask your health care||
0583|007|Z|professional for complete information about this product and your||
0583|008|Z|specific health needs.||
0583|009|B|||
0583|010|T|SERTACONAZOLE - TOPICAL||
0583|011|F|(ser-ta-CAW-nah-zole)||
0583|012|B|||
0583|013|C|COMMON BRAND NAME(S): Ertaczo||
0583|014|B|||
0583|015|U|USES:  This medication is used to treat athlete's foot. It is an||
0583|016|U|azole antifungal that works by preventing the growth of fungus.||
0583|017|B|||
0583|018|V|OTHER USES:  This section contains uses of this drug that are not||
0583|019|V|listed in the approved professional labeling for the drug but||
0583|020|V|that may be prescribed by your health care professional. Use this||
0583|021|V|drug for a condition that is listed in this section only if it||
0583|022|V|has been so prescribed by your health care professional.||
0583|023|V|   This medication may also be used for other fungal skin||
0583|024|V|infections such as ringworm or jock itch.||
0583|025|B|||
0583|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0583|027|H|from your pharmacist before you start using sertaconazole and||
0583|028|H|each time you get a refill. If you have any questions, ask your||
0583|029|H|doctor or pharmacist.||
0583|030|H|   Use this medication on the skin only. Clean and thoroughly dry||
0583|031|H|the area to be treated. Apply this medication to the affected||
0583|032|H|skin as directed by your doctor, usually twice daily. Apply||
0583|033|H|enough medication to cover the affected skin and some of the||
0583|034|H|surrounding skin. After applying this medication, wash your||
0583|035|H|hands. Do not wrap, cover or bandage the area unless directed to||
0583|036|H|do so by your doctor. Do not apply this more often than||
0583|037|H|prescribed. Your condition will not clear faster, but side||
0583|038|H|effects may be increased.||
0583|039|H|   Do not apply this medication in the eyes, nose, mouth, or||
0583|040|H|vagina.||
0583|041|H|   Use this medication regularly in order to get the most benefit||
0583|042|H|from it. Remember to use it at the same times each day.||
0583|043|H|   Continue to use this medication until the full prescribed||
0583|044|H|amount is finished, even if symptoms disappear after a few days.||
0583|045|H|Stopping the medication too early may result in a return of the||
0583|046|H|infection.||
0583|047|H|   Tell your doctor if your condition does not get better after 2||
0583|048|H|weeks of treatment or if it gets worse at any time.||
0583|049|B|||
0583|050|S|SIDE EFFECTS:  Burning, swelling, irritation, tenderness,||
0583|051|S|discoloration, or dry skin may occur. If any of these effects||
0583|052|S|last or get worse, notify your doctor or pharmacist promptly.||
0583|053|S|   Remember that this medication has been prescribed because your||
0583|054|S|doctor has judged that the benefit to you is greater than the||
0583|055|S|risk of side effects. Many people using this medication do not||
0583|056|S|have serious side effects.||
0583|057|S|   Tell your doctor right away if you have any serious side||
0583|058|S|effects, including: blistering, oozing, open sores.||
0583|059|S|   A very serious allergic reaction to this drug is rare.||
0583|060|S|However, get medical help right away if you notice any symptoms||
0583|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0583|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0583|063|S|breathing.||
0583|064|S|   This is not a complete list of possible side effects. If you||
0583|065|S|notice other effects not listed above, contact your doctor or||
0583|066|S|pharmacist.||
0583|067|S|   In the US -||
0583|068|S|   Call your doctor for medical advice about side effects. You||
0583|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0583|070|S|www.fda.gov/medwatch.||
0583|071|S|   In Canada - Call your doctor for medical advice about side||
0583|072|S|effects. You may report side effects to Health Canada at||
0583|073|S|1-866-234-2345.||
0583|074|B|||
0583|075|P|PRECAUTIONS:  Before using sertaconazole, tell your doctor or||
0583|076|P|pharmacist if you are allergic to it; or to other azole||
0583|077|P|antifungals such as clotrimazole, ketoconazole, or miconazole; or||
0583|078|P|if you have any other allergies. This product may contain||
0583|079|P|inactive ingredients, which can cause allergic reactions or other||
0583|080|P|problems. Talk to your pharmacist for more details.||
0583|081|P|   Before using this medication, tell your doctor or pharmacist||
0583|082|P|your medical history.||
0583|083|P|   Before having surgery, tell your doctor or dentist about all||
0583|084|P|the products you use (including prescription drugs,||
0583|085|P|nonprescription drugs, and herbal products).||
0583|086|P|   During pregnancy, this medication should be used only when||
0583|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
0583|088|P|   It is unknown if this drug passes into breast milk. Consult||
0583|089|P|your doctor before breastfeeding.||
0583|090|B|||
0583|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0583|092|I|medications work or increase your risk for serious side effects.||
0583|093|I|This document does not contain all possible drug interactions.||
0583|094|I|Keep a list of all the products you use (including||
0583|095|I|prescription/nonprescription drugs and herbal products) and share||
0583|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
0583|097|I|the dosage of any medicines without your doctor's approval.||
0583|098|B|||
0583|099|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0583|100|O|has overdosed and has serious symptoms such as passing out or||
0583|101|O|trouble breathing, call 911. Otherwise, call a poison control||
0583|102|O|center right away. US residents can call 1-800-222-1222. Canada||
0583|103|O|residents can call 1-844-764-7669.||
0583|104|B|||
0583|105|N|NOTES:  Do not share this medication with others.||
0583|106|N|   This medication has been prescribed for your current condition||
0583|107|N|only. Do not use it later for another infection unless your||
0583|108|N|doctor tells you to.||
0583|109|B|||
0583|110|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0583|111|D|If it is near the time of the next dose, skip the missed dose.||
0583|112|D|Use your next dose at the regular time. Do not double the dose to||
0583|113|D|catch up.||
0583|114|B|||
0583|115|R|STORAGE:  Store at room temperature. Keep all medications away||
0583|116|R|from children and pets.||
0583|117|R|   Do not flush medications down the toilet or pour them into a||
0583|118|R|drain unless instructed to do so. Properly discard this product||
0583|119|R|when it is expired or no longer needed. Consult your pharmacist||
0583|120|R|or local waste disposal company.||
0583|121|B|||
0583|122|A|Information last revised November 2024.||
0583|123|A|Copyright(c) 2025 First Databank, Inc.||
0583|124|B|||
0584|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0584|002|Z|does NOT have all possible information about this product. This||
0584|003|Z|information does not assure that this product is safe, effective,||
0584|004|Z|or appropriate for you. This information is not individual||
0584|005|Z|medical advice and does not substitute for the advice of your||
0584|006|Z|health care professional. Always ask your health care||
0584|007|Z|professional for complete information about this product and your||
0584|008|Z|specific health needs.||
0584|009|B|||
0584|010|T|POLYVINYLPYRROLIDONE/SODIUM HYALURONATE GEL - ORAL||
0584|011|F|(pol-i-VYE-nil-pi-ROH-li-dohn/SO-dee-um hi-uh-LYOU-ron-ate)||
0584|012|B|||
0584|013|C|COMMON BRAND NAME(S): Gelclair||
0584|014|B|||
0584|015|U|USES:  This medication is used to relieve pain from mouth sores||
0584|016|U|and swelling due to various causes including chemotherapy,||
0584|017|U|radiation treatment, dental surgery/devices, and disease.||
0584|018|U|Reducing pain helps you to eat and drink more comfortably. This||
0584|019|U|medication works by forming a protective coating over the inside||
0584|020|U|of the mouth to cover the irritation. It also keeps the mouth||
0584|021|U|moist which promotes healing.||
0584|022|B|||
0584|023|H|HOW TO USE:  Open the packet and pour the gel into a glass. Add 1||
0584|024|H|tablespoonful (15 milliliters) of water and stir the mixture||
0584|025|H|well. If the liquid is too thick, you may add 1 to 2||
0584|026|H|tablespoonfuls (15 to 30 milliliters) more water. Rinse your||
0584|027|H|mouth thoroughly with the liquid for at least 1 minute or as long||
0584|028|H|as possible, then gargle and spit out.||
0584|029|H|   Use this medication as directed by your doctor, usually 3||
0584|030|H|times a day. Do not eat or drink for at least 1 hour after use.||
0584|031|H|This medication may be used without mixing with water if||
0584|032|H|necessary.||
0584|033|H|   Tell your doctor if your condition does not get better after 7||
0584|034|H|days of treatment.||
0584|035|B|||
0584|036|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0584|037|S|because your doctor has judged that the benefit to you is greater||
0584|038|S|than the risk of side effects. Many people using this medication||
0584|039|S|do not have serious side effects.||
0584|040|S|   A very serious allergic reaction to this drug is rare.||
0584|041|S|However, get medical help right away if you notice any symptoms||
0584|042|S|of a serious allergic reaction, including: rash, itching/swelling||
0584|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0584|044|S|breathing.||
0584|045|S|   This is not a complete list of possible side effects. If you||
0584|046|S|notice other effects not listed above, contact your doctor or||
0584|047|S|pharmacist.||
0584|048|S|   In the US -||
0584|049|S|   Call your doctor for medical advice about side effects. You||
0584|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0584|051|S|www.fda.gov/medwatch.||
0584|052|S|   In Canada - Call your doctor for medical advice about side||
0584|053|S|effects. You may report side effects to Health Canada at||
0584|054|S|1-866-234-2345.||
0584|055|B|||
0584|056|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0584|057|P|pharmacist if you are allergic to it; or if you have any other||
0584|058|P|allergies. This product may contain inactive ingredients, which||
0584|059|P|can cause allergic reactions or other problems. Talk to your||
0584|060|P|pharmacist for more details.||
0584|061|P|   Before using this medication, tell your doctor or pharmacist||
0584|062|P|your medical history.||
0584|063|P|   Tell your doctor if you are pregnant before using this||
0584|064|P|medication.||
0584|065|P|   It is unknown if this medication passes into breast milk.||
0584|066|P|Consult your doctor before breastfeeding.||
0584|067|B|||
0584|068|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0584|069|I|medications work or increase your risk for serious side effects.||
0584|070|I|This document does not contain all possible drug interactions.||
0584|071|I|Keep a list of all the products you use (including||
0584|072|I|prescription/nonprescription drugs and herbal products) and share||
0584|073|I|it with your doctor and pharmacist. Do not start, stop, or change||
0584|074|I|the dosage of any medicines without your doctor's approval.||
0584|075|B|||
0584|076|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0584|077|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0584|078|O|poison control center right away. US residents can call||
0584|079|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0584|080|B|||
0584|081|N|NOTES:  Do not share this medication with others.||
0584|082|B|||
0584|083|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0584|084|D|If it is near the time of the next dose, skip the missed dose.||
0584|085|D|Use your next dose at the regular time. Do not double the dose to||
0584|086|D|catch up.||
0584|087|B|||
0584|088|R|STORAGE:  Store at room temperature away from direct sunlight. Do||
0584|089|R|not refrigerate. Do not use any packets that are torn or damaged.||
0584|090|R|Over time, the gel may become a little thicker or darker in||
0584|091|R|color. However, you may still use it as long as the expiration||
0584|092|R|date has not been reached. Keep all medications away from||
0584|093|R|children and pets.||
0584|094|R|   Do not flush medications down the toilet or pour them into a||
0584|095|R|drain unless instructed to do so. Properly discard this product||
0584|096|R|when it is expired or no longer needed. Consult your pharmacist||
0584|097|R|or local waste disposal company.||
0584|098|B|||
0584|099|A|Information last revised November 2024.||
0584|100|A|Copyright(c) 2025 First Databank, Inc.||
0584|101|B|||
0585|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0585|002|Z|does NOT have all possible information about this product. This||
0585|003|Z|information does not assure that this product is safe, effective,||
0585|004|Z|or appropriate for you. This information is not individual||
0585|005|Z|medical advice and does not substitute for the advice of your||
0585|006|Z|health care professional. Always ask your health care||
0585|007|Z|professional for complete information about this product and your||
0585|008|Z|specific health needs.||
0585|009|B|||
0585|010|T|LIOTHYRONINE - ORAL||
0585|011|F|(LYE-oh-THYE-roe-neen)||
0585|012|B|||
0585|013|C|COMMON BRAND NAME(S): Cytomel||
0585|014|B|||
0585|015|W|WARNING:  This medication should not be used for weight loss.||
0585|016|W|Normal doses of this medication will not work for weight loss,||
0585|017|W|and large doses may cause serious, possibly fatal side effects,||
0585|018|W|especially when taken with diet pills.||
0585|019|B|||
0585|020|U|USES:  Liothyronine is used to treat an underactive thyroid||
0585|021|U|(hypothyroidism). It replaces or provides more thyroid hormone,||
0585|022|U|which is normally made by the thyroid gland. Liothyronine is a||
0585|023|U|man-made form of thyroid hormone. Low thyroid hormone levels can||
0585|024|U|occur naturally or when the thyroid gland is injured by||
0585|025|U|radiation/medications or removed by surgery. Having enough||
0585|026|U|thyroid hormone helps you stay healthy. For children, having||
0585|027|U|enough thyroid hormone helps them grow and learn normally.||
0585|028|U|   This medication is also used to treat other types of thyroid||
0585|029|U|problems (such as certain types of goiters, thyroid cancer). It||
0585|030|U|can also be used to test for certain types of thyroid disease.||
0585|031|U|   This medication should not be used to treat infertility unless||
0585|032|U|it is caused by low thyroid hormone levels.||
0585|033|B|||
0585|034|H|HOW TO USE:  Take this medication by mouth with or without food||
0585|035|H|as directed by your doctor, usually once daily. It is best to||
0585|036|H|take it at the same time each day so your thyroid hormone level||
0585|037|H|is kept at a constant level.||
0585|038|H|   Take this medication regularly to get the most benefit from||
0585|039|H|it. Do not stop taking it without first talking with your doctor.||
0585|040|H|Thyroid replacement treatment is usually taken for life.||
0585|041|H|   The dosage is based on your medical condition, age, lab test||
0585|042|H|results, and response to treatment.||
0585|043|H|   Certain medications can decrease the absorption of||
0585|044|H|liothyronine. Examples include products that contain aluminum or||
0585|045|H|magnesium, antacids, sucralfate, calcium supplements, iron, bile||
0585|046|H|acid-binding resins (such as cholestyramine, colestipol,||
0585|047|H|colesevelam), simethicone, sevelamer, sodium polystyrene||
0585|048|H|sulfonate, among others. If you take any of these medications,||
0585|049|H|take them at least 4 hours before or after liothyronine. If you||
0585|050|H|take lanthanum, take it at least 2 hours before or after||
0585|051|H|liothyronine.||
0585|052|H|   Symptoms of low thyroid hormone levels include tiredness,||
0585|053|H|muscle aches, constipation, dry skin, weight gain, slow||
0585|054|H|heartbeat, or sensitivity to cold. You may see an improvement in||
0585|055|H|these symptoms within a few days. Tell your doctor if you do not||
0585|056|H|get better or if you get worse.||
0585|057|B|||
0585|058|S|SIDE EFFECTS:  Temporary hair loss may occur during the first few||
0585|059|S|months of starting this drug, especially in children. If this||
0585|060|S|effect lasts or gets worse, tell your doctor or pharmacist||
0585|061|S|promptly.||
0585|062|S|   Remember that this medication has been prescribed because your||
0585|063|S|doctor has judged that the benefit to you is greater than the||
0585|064|S|risk of side effects. Many people using this medication do not||
0585|065|S|have serious side effects.||
0585|066|S|   Though unlikely, it is possible to have too much thyroid||
0585|067|S|hormone. Tell your doctor right away if you have symptoms of too||
0585|068|S|much thyroid hormone, including: headache, mental/mood changes||
0585|069|S|(such as irritability, nervousness), increased sweating,||
0585|070|S|sensitivity to heat, diarrhea, menstrual changes.||
0585|071|S|   Get medical help right away if you have any very serious||
0585|072|S|symptoms of too much thyroid hormone, including: chest pain,||
0585|073|S|fast/pounding/irregular heartbeat, swelling ankles/feet, trouble||
0585|074|S|breathing, unusual tiredness.||
0585|075|S|   A very serious allergic reaction to this drug is rare.||
0585|076|S|However, get medical help right away if you notice any symptoms||
0585|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0585|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0585|079|S|breathing.||
0585|080|S|   This is not a complete list of possible side effects. If you||
0585|081|S|notice other effects not listed above, contact your doctor or||
0585|082|S|pharmacist.||
0585|083|S|   In the US -||
0585|084|S|   Call your doctor for medical advice about side effects. You||
0585|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0585|086|S|www.fda.gov/medwatch.||
0585|087|S|   In Canada - Call your doctor for medical advice about side||
0585|088|S|effects. You may report side effects to Health Canada at||
0585|089|S|1-866-234-2345.||
0585|090|B|||
0585|091|P|PRECAUTIONS:  Before taking liothyronine, tell your doctor or||
0585|092|P|pharmacist if you are allergic to it; or if you have any other||
0585|093|P|allergies. This product may contain inactive ingredients, which||
0585|094|P|can cause allergic reactions or other problems. Talk to your||
0585|095|P|pharmacist for more details.||
0585|096|P|   Before using this medication, tell your doctor or pharmacist||
0585|097|P|your medical history, especially of: decreased adrenal gland||
0585|098|P|function, heart disease (such as chest pain, heart failure,||
0585|099|P|irregular heartbeat, heart attack), high blood pressure,||
0585|100|P|diabetes, water diabetes (diabetes insipidus).||
0585|101|P|   Before having surgery, tell your doctor or dentist about all||
0585|102|P|the products you use (including prescription drugs,||
0585|103|P|nonprescription drugs, and herbal products).||
0585|104|P|   Current information shows that this drug may be used during||
0585|105|P|pregnancy. Tell your doctor if you are pregnant because your||
0585|106|P|doctor may need to change your dose.||
0585|107|P|   Liothyronine passes into breast milk but is unlikely to harm a||
0585|108|P|nursing infant. Consult your doctor before breastfeeding.||
0585|109|B|||
0585|110|I|DRUG INTERACTIONS:  See also How to Use section.||
0585|111|I|   Drug interactions may change how your medications work or||
0585|112|I|increase your risk for serious side effects. This document does||
0585|113|I|not contain all possible drug interactions. Keep a list of all||
0585|114|I|the products you use (including prescription/nonprescription||
0585|115|I|drugs and herbal products) and share it with your doctor and||
0585|116|I|pharmacist. Do not start, stop, or change the dosage of any||
0585|117|I|medicines without your doctor's approval.||
0585|118|B|||
0585|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0585|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0585|121|O|poison control center right away. US residents can call||
0585|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0585|123|O|Symptoms of overdose may include: fast/irregular heartbeat, chest||
0585|124|O|pain, trouble breathing, confusion.||
0585|125|B|||
0585|126|N|NOTES:  Do not share this medication with others.||
0585|127|N|   Lab and/or medical tests (such as thyroid function) should be||
0585|128|N|done while you are taking this medication. Keep all medical and||
0585|129|N|lab appointments.||
0585|130|B|||
0585|131|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0585|132|D|remember. If it is near the time of the next dose, skip the||
0585|133|D|missed dose. Take your next dose at the regular time. Do not||
0585|134|D|double the dose to catch up unless your doctor instructs you to||
0585|135|D|do so. Call your doctor if you miss 2 or more doses in a row. Ask||
0585|136|D|your doctor ahead of time what to do about a missed dose and||
0585|137|D|follow your doctor's specific directions.||
0585|138|B|||
0585|139|R|STORAGE:  Store at room temperature away from light and moisture.||
0585|140|R|Do not store in the bathroom. Keep all medications away from||
0585|141|R|children and pets.||
0585|142|R|   Do not flush medications down the toilet or pour them into a||
0585|143|R|drain unless instructed to do so. Properly discard this product||
0585|144|R|when it is expired or no longer needed. Consult your pharmacist||
0585|145|R|or local waste disposal company.||
0585|146|B|||
0585|147|A|Information last revised January 2025.||
0585|148|A|Copyright(c) 2025 First Databank, Inc.||
0585|149|B|||
0586|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0586|002|Z|does NOT have all possible information about this product. This||
0586|003|Z|information does not assure that this product is safe, effective,||
0586|004|Z|or appropriate for you. This information is not individual||
0586|005|Z|medical advice and does not substitute for the advice of your||
0586|006|Z|health care professional. Always ask your health care||
0586|007|Z|professional for complete information about this product and your||
0586|008|Z|specific health needs.||
0586|009|B|||
0586|010|T|ATENOLOL/CHLORTHALIDONE - ORAL||
0586|011|F|(a-TEN-oh-lol/klor-THAL-i-done)||
0586|012|B|||
0586|013|C|COMMON BRAND NAME(S): Tenoretic||
0586|014|B|||
0586|015|W|WARNING:  Do not stop taking this medication without consulting||
0586|016|W|your doctor. Some conditions may become worse when you suddenly||
0586|017|W|stop this drug. Some people who have suddenly stopped taking||
0586|018|W|similar drugs have had chest pain, heart attack, and irregular||
0586|019|W|heartbeat. If your doctor decides you should no longer use this||
0586|020|W|drug, your doctor may direct you to gradually decrease your dose||
0586|021|W|over 1 to 2 weeks.||
0586|022|W|   When gradually stopping this medication, it is recommended||
0586|023|W|that you temporarily limit physical activity to decrease strain||
0586|024|W|on the heart. Get medical help right away if you develop chest||
0586|025|W|pain/tightness/pressure, chest pain spreading to the||
0586|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
0586|027|W|fast/irregular heartbeat.||
0586|028|B|||
0586|029|U|USES:  This medication is used to treat high blood pressure||
0586|030|U|(hypertension). Lowering high blood pressure helps prevent||
0586|031|U|strokes, heart attacks, and kidney problems. This product||
0586|032|U|contains 2 medications: atenolol and chlorthalidone. Atenolol||
0586|033|U|belongs to a class of drugs known as beta blockers. It works by||
0586|034|U|blocking the action of certain natural chemicals in your body,||
0586|035|U|such as epinephrine, on the heart and blood vessels. This effect||
0586|036|U|lowers the heart rate, blood pressure, and strain on the heart.||
0586|037|U|Chlorthalidone is a "water pill" (diuretic) and causes your body||
0586|038|U|to get rid of extra salt and water. This effect may increase the||
0586|039|U|amount of urine you make when you first start the medication. It||
0586|040|U|also helps to relax the blood vessels so that blood can flow more||
0586|041|U|easily.||
0586|042|U|   These medications are used together when 1 drug alone is not||
0586|043|U|controlling your blood pressure. Your doctor may direct you to||
0586|044|U|start taking the individual medications first, and then switch||
0586|045|U|you over to this combination product if this is the best dose||
0586|046|U|combination for you.||
0586|047|B|||
0586|048|H|HOW TO USE:  See also Warning section.||
0586|049|H|   Take this medication by mouth with or without food as directed||
0586|050|H|by your doctor, usually once daily. If you take this drug too||
0586|051|H|close to bedtime, you may need to wake up to urinate. It is best||
0586|052|H|to take this medication at least 4 hours before your bedtime.||
0586|053|H|Consult your doctor or pharmacist if you have questions about||
0586|054|H|your dosing schedule.||
0586|055|H|   Apple juice and orange juice may prevent your body from fully||
0586|056|H|absorbing atenolol. It is best to avoid drinking apple/orange||
0586|057|H|juice within 4 hours of taking this medication, unless your||
0586|058|H|doctor or pharmacist tells you otherwise.||
0586|059|H|   The dosage is based on your medical condition and response to||
0586|060|H|treatment.||
0586|061|H|   Use this medication regularly to get the most benefit from it.||
0586|062|H|To help you remember, take it at the same time each day.||
0586|063|H|   If you also take certain drugs to lower your cholesterol (bile||
0586|064|H|acid-binding resins such as cholestyramine or colestipol), take||
0586|065|H|this product at least 2 hours before or at least 4 hours after||
0586|066|H|these medications.||
0586|067|H|   It may take several weeks before you get the full benefit of||
0586|068|H|this medication. Keep taking this medication even if you feel||
0586|069|H|well. Most people with high blood pressure do not feel sick.||
0586|070|H|   Tell your doctor if your condition does not get better or if||
0586|071|H|it gets worse (your blood pressure readings remain high or||
0586|072|H|increase).||
0586|073|B|||
0586|074|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
0586|075|S|   Dizziness, lightheadedness, tiredness, nausea, and diarrhea||
0586|076|S|may occur. If any of these effects last or get worse, tell your||
0586|077|S|doctor or pharmacist promptly.||
0586|078|S|   To reduce the risk of dizziness and lightheadedness, get up||
0586|079|S|slowly when rising from a sitting or lying position.||
0586|080|S|   This product may reduce blood flow to your hands and feet,||
0586|081|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0586|082|S|warmly and avoid tobacco use.||
0586|083|S|   Remember that this medication has been prescribed because your||
0586|084|S|doctor has judged that the benefit to you is greater than the||
0586|085|S|risk of side effects. Many people using this medication do not||
0586|086|S|have serious side effects.||
0586|087|S|   This product may cause dehydration and electrolyte imbalance.||
0586|088|S|Tell your doctor right away if you have any symptoms of||
0586|089|S|dehydration or electrolyte imbalance, including unusual dry||
0586|090|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0586|091|S|heartbeat, or confusion.||
0586|092|S|   Tell your doctor right away if you have any serious side||
0586|093|S|effects, including: very slow heartbeat, fainting, signs of||
0586|094|S|kidney problems (such as change in the amount of urine),||
0586|095|S|toe/joint pain, mental/mood changes (such as depression, mood||
0586|096|S|swings), blue fingers/toes, new or worsening symptoms of heart||
0586|097|S|failure (such as shortness of breath, swelling ankles/feet,||
0586|098|S|unusual tiredness, unusual/sudden weight gain).||
0586|099|S|   Get medical help right away if you have any very serious side||
0586|100|S|effects, including: decrease in vision, eye pain.||
0586|101|S|   A very serious allergic reaction to this drug is rare.||
0586|102|S|However, get medical help right away if you notice any symptoms||
0586|103|S|of a serious allergic reaction, including: rash, itching/swelling||
0586|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0586|105|S|breathing.||
0586|106|S|   This is not a complete list of possible side effects. If you||
0586|107|S|notice other effects not listed above, contact your doctor or||
0586|108|S|pharmacist.||
0586|109|S|   In the US -||
0586|110|S|   Call your doctor for medical advice about side effects. You||
0586|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0586|112|S|www.fda.gov/medwatch.||
0586|113|S|   In Canada - Call your doctor for medical advice about side||
0586|114|S|effects. You may report side effects to Health Canada at||
0586|115|S|1-866-234-2345.||
0586|116|B|||
0586|117|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0586|118|P|pharmacist if you are allergic to atenolol or chlorthalidone; or||
0586|119|P|if you have any other allergies. This product may contain||
0586|120|P|inactive ingredients, which can cause allergic reactions or other||
0586|121|P|problems. Talk to your pharmacist for more details.||
0586|122|P|   Before using this medication, tell your doctor or pharmacist||
0586|123|P|your medical history, especially of: liver disease, kidney||
0586|124|P|disease, certain types of heart rhythm problems (such as a slow||
0586|125|P|heartbeat, second- or third-degree atrioventricular block), gout,||
0586|126|P|lupus, breathing problems (such as asthma, chronic bronchitis,||
0586|127|P|emphysema), blood circulation problems (such as Raynaud's||
0586|128|P|disease, peripheral vascular disease), untreated mineral||
0586|129|P|imbalance (such as low potassium), serious allergic reactions||
0586|130|P|including those needing treatment with epinephrine, a certain||
0586|131|P|muscle/nerve disease (myasthenia gravis).||
0586|132|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0586|133|P|can make you more dizzy. Do not drive, use machinery, or do||
0586|134|P|anything that needs alertness until you can do it safely. Limit||
0586|135|P|alcoholic beverages. Talk to your doctor if you are using||
0586|136|P|marijuana (cannabis).||
0586|137|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0586|138|P|and cause you to feel lightheaded. Tell your doctor if you have||
0586|139|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0586|140|P|of fluids unless your doctor tells you not to.||
0586|141|P|   Before having surgery, tell your doctor or dentist about all||
0586|142|P|the products you use (including prescription drugs,||
0586|143|P|nonprescription drugs, and herbal products).||
0586|144|P|   This medication may reduce the potassium levels in your blood.||
0586|145|P|Ask your doctor about adding potassium to your diet. Your doctor||
0586|146|P|may prescribe a potassium supplement.||
0586|147|P|   This product may prevent the fast/pounding heartbeat you would||
0586|148|P|usually feel when your blood sugar level falls too low||
0586|149|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0586|150|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0586|151|P|blood sugar level, such as dizziness and sweating, are not||
0586|152|P|affected by this drug.||
0586|153|P|   If you have diabetes, this product may make it harder to||
0586|154|P|control your blood sugar levels. Check your blood sugar levels||
0586|155|P|regularly as directed by your doctor. Tell your doctor right away||
0586|156|P|if you have symptoms of high blood sugar such as increased||
0586|157|P|thirst/urination. Your doctor may need to adjust your diabetes||
0586|158|P|medication, exercise program, or diet.||
0586|159|P|   This medication may make you more sensitive to the sun. Limit||
0586|160|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0586|161|P|sunscreen and wear protective clothing when outdoors. Tell your||
0586|162|P|doctor right away if you get sunburned or have skin||
0586|163|P|blisters/redness.||
0586|164|P|   Older adults may be more sensitive to the side effects of this||
0586|165|P|drug, especially dizziness.||
0586|166|P|   Tell your doctor if you are pregnant or plan to become||
0586|167|P|pregnant. You should not become pregnant while using this||
0586|168|P|medication. Atenolol may harm an unborn baby. If you become||
0586|169|P|pregnant, talk to your doctor right away about the risks and||
0586|170|P|benefits of this medication.||
0586|171|P|   Atenolol and chlorthalidone pass into breast milk. Atenolol||
0586|172|P|may harm a nursing infant. Consult your doctor before||
0586|173|P|breastfeeding.||
0586|174|B|||
0586|175|I|DRUG INTERACTIONS:  See also How to Use section.||
0586|176|I|   Drug interactions may change how your medications work or||
0586|177|I|increase your risk for serious side effects. This document does||
0586|178|I|not contain all possible drug interactions. Keep a list of all||
0586|179|I|the products you use (including prescription/nonprescription||
0586|180|I|drugs and herbal products) and share it with your doctor and||
0586|181|I|pharmacist. Do not start, stop, or change the dosage of any||
0586|182|I|medicines without your doctor's approval.||
0586|183|I|   Some products that may interact with this drug include:||
0586|184|I|dofetilide, fingolimod, lithium.||
0586|185|I|   Some products have ingredients that could raise your heart||
0586|186|I|rate or blood pressure. Tell your pharmacist what products you||
0586|187|I|are using, and ask how to use them safely (especially||
0586|188|I|cough-and-cold products, diet aids, or NSAIDs such as||
0586|189|I|ibuprofen/naproxen).||
0586|190|I|   This medication may interfere with certain lab tests (such as||
0586|191|I|parathyroid, protein-bound iodide), possibly causing false test||
0586|192|I|results. Make sure lab personnel and all your doctors know you||
0586|193|I|use this drug.||
0586|194|B|||
0586|195|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0586|196|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0586|197|O|poison control center right away. US residents can call||
0586|198|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0586|199|O|Symptoms of overdose may include: severe dizziness, fainting,||
0586|200|O|very slow heartbeat, trouble breathing.||
0586|201|B|||
0586|202|N|NOTES:  Do not share this medication with others.||
0586|203|N|   Lifestyle changes that may help this medication work better||
0586|204|N|include stress reduction programs, exercise, and dietary changes.||
0586|205|N|Talk to your doctor or pharmacist about lifestyle changes that||
0586|206|N|might benefit you.||
0586|207|N|   Lab and/or medical tests (including kidney function, blood||
0586|208|N|mineral levels such as potassium) should be done while you are||
0586|209|N|taking this medication. Keep all medical and lab appointments.||
0586|210|N|Consult your doctor for more details.||
0586|211|N|   Have your blood pressure and heart rate checked regularly||
0586|212|N|while taking this medication. Learn how to check your own blood||
0586|213|N|pressure and heart rate at home, and share the results with your||
0586|214|N|doctor.||
0586|215|B|||
0586|216|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0586|217|D|remember. If it is near the time of the next dose, skip the||
0586|218|D|missed dose. Take your next dose at the regular time. Do not||
0586|219|D|double the dose to catch up.||
0586|220|B|||
0586|221|R|STORAGE:  Store at room temperature away from light and moisture.||
0586|222|R|Do not store in the bathroom. Keep all medications away from||
0586|223|R|children and pets.||
0586|224|R|   Do not flush medications down the toilet or pour them into a||
0586|225|R|drain unless instructed to do so. Properly discard this product||
0586|226|R|when it is expired or no longer needed. Consult your pharmacist||
0586|227|R|or local waste disposal company.||
0586|228|B|||
0586|229|A|Information last revised May 2024.||
0586|230|A|Copyright(c) 2025 First Databank, Inc.||
0586|231|B|||
0587|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0587|002|Z|does NOT have all possible information about this product. This||
0587|003|Z|information does not assure that this product is safe, effective,||
0587|004|Z|or appropriate for you. This information is not individual||
0587|005|Z|medical advice and does not substitute for the advice of your||
0587|006|Z|health care professional. Always ask your health care||
0587|007|Z|professional for complete information about this product and your||
0587|008|Z|specific health needs.||
0587|009|B|||
0587|010|T|FOSINOPRIL/HYDROCHLOROTHIAZIDE - ORAL||
0587|011|F|(fos-IN-oh-pril/HYE-droe-KLOR-oh-THYE-a-zide)||
0587|012|B|||
0587|013|C|COMMON BRAND NAME(S): Monopril HCT||
0587|014|B|||
0587|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
0587|016|W|unborn baby if used during pregnancy. It is important to prevent||
0587|017|W|pregnancy while taking this medication. Consult your doctor for||
0587|018|W|more details and to discuss the use of reliable forms of birth||
0587|019|W|control. If you are planning pregnancy, become pregnant, or think||
0587|020|W|you may be pregnant, contact your doctor right away.||
0587|021|B|||
0587|022|U|USES:  This medication is used to treat high blood pressure||
0587|023|U|(hypertension). Lowering high blood pressure helps prevent||
0587|024|U|strokes, heart attacks, and kidney problems. This product||
0587|025|U|contains 2 medications, fosinopril and hydrochlorothiazide.||
0587|026|U|Fosinopril belongs to a class of drugs known as ACE inhibitors.||
0587|027|U|It works by relaxing blood vessels so that blood can flow more||
0587|028|U|easily. Hydrochlorothiazide is a "water pill" (diuretic) and||
0587|029|U|causes your body to get rid of extra salt and water. This effect||
0587|030|U|may increase the amount of urine you make when you first start||
0587|031|U|the medication. It also helps to relax the blood vessels so that||
0587|032|U|blood can flow more easily.||
0587|033|B|||
0587|034|V|OTHER USES:  This section contains uses of this drug that are not||
0587|035|V|listed in the approved professional labeling for the drug but||
0587|036|V|that may be prescribed by your health care professional. Use this||
0587|037|V|drug for a condition that is listed in this section only if it||
0587|038|V|has been so prescribed by your health care professional.||
0587|039|V|   This drug may also be used for heart failure.||
0587|040|B|||
0587|041|H|HOW TO USE:  Take this medication by mouth with or without food||
0587|042|H|as directed by your doctor, usually once daily. If you take this||
0587|043|H|drug too close to bedtime, you may need to wake up to urinate. It||
0587|044|H|is best to take this medication at least 4 hours before your||
0587|045|H|bedtime. Consult your doctor or pharmacist if you have questions||
0587|046|H|about when to take this medication.||
0587|047|H|   The dosage is based on your medical condition and response to||
0587|048|H|treatment.||
0587|049|H|   Antacids containing aluminum or magnesium can decrease the||
0587|050|H|absorption of fosinopril. If you are taking an antacid that||
0587|051|H|contains aluminum or magnesium, take it at least 2 hours before||
0587|052|H|or 2 hours after taking this product.||
0587|053|H|   If you also take certain drugs to lower your cholesterol (bile||
0587|054|H|acid-binding resins such as cholestyramine or colestipol), take||
0587|055|H|fosinopril/hydrochlorothiazide at least 4 hours before or at||
0587|056|H|least 4 to 6 hours after these medications.||
0587|057|H|   Use this medication regularly to get the most benefit from it.||
0587|058|H|To help you remember, take it at the same time each day.||
0587|059|H|   It may take several weeks before you get the full benefit of||
0587|060|H|this medication. Keep taking this medication even if you feel||
0587|061|H|well. Most people with high blood pressure do not feel sick.||
0587|062|H|   Tell your doctor if your condition does not get better or if||
0587|063|H|it gets worse (your blood pressure readings remain high or||
0587|064|H|increase).||
0587|065|B|||
0587|066|S|SIDE EFFECTS:  Dizziness, lightheadedness, or tiredness may occur||
0587|067|S|as your body adjusts to the medication. Dry cough may also occur.||
0587|068|S|If any of these effects last or get worse, tell your doctor or||
0587|069|S|pharmacist promptly.||
0587|070|S|   To reduce the risk of dizziness and lightheadedness, get up||
0587|071|S|slowly when rising from a sitting or lying position.||
0587|072|S|   Remember that this medication has been prescribed because your||
0587|073|S|doctor has judged that the benefit to you is greater than the||
0587|074|S|risk of side effects. Many people using this medication do not||
0587|075|S|have serious side effects.||
0587|076|S|   This product may cause dehydration and electrolyte imbalance.||
0587|077|S|Tell your doctor right away if you have any symptoms of||
0587|078|S|dehydration or electrolyte imbalance, including unusual dry||
0587|079|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0587|080|S|heartbeat, or confusion.||
0587|081|S|   Tell your doctor right away if you have any serious side||
0587|082|S|effects, including: fainting, toe/joint pain, decrease in vision,||
0587|083|S|eye pain, easy bruising/bleeding, signs of kidney problems (such||
0587|084|S|as change in the amount of urine).||
0587|085|S|   This drug may rarely cause serious (possibly fatal) liver||
0587|086|S|problems. Get medical help right away if you have any symptoms of||
0587|087|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0587|088|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0587|089|S|urine.||
0587|090|S|   A very serious allergic reaction to this drug is rare.||
0587|091|S|However, get medical help right away if you notice any symptoms||
0587|092|S|of a serious allergic reaction, including: rash, itching/swelling||
0587|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0587|094|S|breathing.||
0587|095|S|   This is not a complete list of possible side effects. If you||
0587|096|S|notice other effects not listed above, contact your doctor or||
0587|097|S|pharmacist.||
0587|098|S|   In the US -||
0587|099|S|   Call your doctor for medical advice about side effects. You||
0587|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0587|101|S|www.fda.gov/medwatch.||
0587|102|S|   In Canada - Call your doctor for medical advice about side||
0587|103|S|effects. You may report side effects to Health Canada at||
0587|104|S|1-866-234-2345.||
0587|105|B|||
0587|106|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0587|107|P|pharmacist if you are allergic to either fosinopril or||
0587|108|P|hydrochlorothiazide; or to other ACE inhibitors (such as||
0587|109|P|captopril, lisinopril); or to other thiazides (such as||
0587|110|P|chlorothiazide); or if you have any other allergies. This product||
0587|111|P|may contain inactive ingredients, which can cause allergic||
0587|112|P|reactions or other problems. Talk to your pharmacist for more||
0587|113|P|details.||
0587|114|P|   Before using this medication, tell your doctor or pharmacist||
0587|115|P|your medical history, especially of: a history of an allergic||
0587|116|P|reaction that included swelling of the face/lips/tongue/throat||
0587|117|P|(angioedema), liver disease, kidney disease (such as renal artery||
0587|118|P|stenosis), lupus, gout, untreated salt imbalance (such as high||
0587|119|P|calcium, high or low potassium, low magnesium), dehydration,||
0587|120|P|blood filtering procedures (such as LDL apheresis, dialysis),||
0587|121|P|skin cancer.||
0587|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0587|123|P|can make you more dizzy. Do not drive, use machinery, or do||
0587|124|P|anything that needs alertness until you can do it safely. Limit||
0587|125|P|alcoholic beverages. Talk to your doctor if you are using||
0587|126|P|marijuana (cannabis).||
0587|127|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0587|128|P|and cause you to feel lightheaded. Tell your doctor if you have||
0587|129|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0587|130|P|of fluids unless your doctor tells you not to.||
0587|131|P|   Before having surgery, tell your doctor or dentist about all||
0587|132|P|the products you use (including prescription drugs,||
0587|133|P|nonprescription drugs, and herbal products).||
0587|134|P|   This medication may make you more sensitive to the sun. It may||
0587|135|P|also increase your risk for skin cancer, especially if you take||
0587|136|P|it for a long time. Limit your time in the sun. Avoid tanning||
0587|137|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0587|138|P|when outdoors. Tell your doctor right away if you get sunburned,||
0587|139|P|have skin blisters/redness, or notice new or changed moles/skin||
0587|140|P|lesions.||
0587|141|P|   This product may affect your potassium levels, which could||
0587|142|P|cause side effects. Before using potassium supplements or salt||
0587|143|P|substitutes that contain potassium, consult your doctor or||
0587|144|P|pharmacist.||
0587|145|P|   If you have diabetes, this product may affect your blood||
0587|146|P|sugar. Check your blood sugar regularly as directed and share the||
0587|147|P|results with your doctor. Tell your doctor right away if you have||
0587|148|P|symptoms of high blood sugar such as increased thirst/urination,||
0587|149|P|or signs of low blood sugar such as sudden sweating, shaking,||
0587|150|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
0587|151|P|hands/feet. Your doctor may need to adjust your diabetes||
0587|152|P|medication, exercise program, or diet.||
0587|153|P|   Older adults may be more sensitive to the side effects of this||
0587|154|P|drug, especially dizziness and change in the amount of urine||
0587|155|P|(kidney problems).||
0587|156|P|   Tell your doctor if you are pregnant or plan to become||
0587|157|P|pregnant. You should not become pregnant while using this||
0587|158|P|product. Fosinopril may harm an unborn baby. If you become||
0587|159|P|pregnant, talk to your doctor right away about the risks and||
0587|160|P|benefits of this medication. (See also Warning section.)||
0587|161|P|   Fosinopril and hydrochlorothiazide pass into breast milk.||
0587|162|P|Consult your doctor before breastfeeding.||
0587|163|B|||
0587|164|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
0587|165|I|   Drug interactions may change how your medications work or||
0587|166|I|increase your risk for serious side effects. This document does||
0587|167|I|not contain all possible drug interactions. Keep a list of all||
0587|168|I|the products you use (including prescription/nonprescription||
0587|169|I|drugs and herbal products) and share it with your doctor and||
0587|170|I|pharmacist. Do not start, stop, or change the dosage of any||
0587|171|I|medicines without your doctor's approval.||
0587|172|I|   Some products that may interact with this drug are: aliskiren,||
0587|173|I|dofetilide, certain drugs that weaken the immune system/increase||
0587|174|I|the risk of infection (such as everolimus, sirolimus), lithium,||
0587|175|I|drugs that may increase the level of potassium in the blood (such||
0587|176|I|as ARBs including losartan/valsartan, birth control pills||
0587|177|I|containing drospirenone), gold injections, sacubitril.||
0587|178|I|   A very serious reaction may occur if you are getting||
0587|179|I|injections for bee/wasp sting allergy (desensitization) and are||
0587|180|I|also taking fosinopril/hydrochlorothiazide. Make sure all your||
0587|181|I|doctors know which medicines you are using.||
0587|182|I|   Some products have ingredients that could raise your blood||
0587|183|I|pressure or worsen your heart failure. Tell your pharmacist what||
0587|184|I|products you are using, and ask how to use them safely||
0587|185|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0587|186|I|ibuprofen/naproxen).||
0587|187|I|   This medication may interfere with certain lab tests (such as||
0587|188|I|parathyroid, protein-bound iodide, tyramine, phentolamine, and||
0587|189|I|certain digoxin drug level tests), possibly causing false test||
0587|190|I|results. Make sure lab personnel and all your doctors know you||
0587|191|I|use this drug.||
0587|192|B|||
0587|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0587|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0587|195|O|poison control center right away. US residents can call||
0587|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0587|197|O|Symptoms of overdose may include: severe dizziness.||
0587|198|B|||
0587|199|N|NOTES:  Do not share this medication with others.||
0587|200|N|   Talk with your doctor about making lifestyle changes that may||
0587|201|N|help this medication work better (such as stress reduction||
0587|202|N|programs, exercise, and dietary changes).||
0587|203|N|   Lab and/or medical tests (such as kidney/liver function, blood||
0587|204|N|mineral levels such as potassium, skin exams, cholesterol levels)||
0587|205|N|should be done while you are taking this medication. Keep all||
0587|206|N|medical and lab appointments. Consult your doctor for more||
0587|207|N|details.||
0587|208|N|   Have your blood pressure checked regularly while taking this||
0587|209|N|medication. Learn how to check your own blood pressure at home,||
0587|210|N|and share the results with your doctor.||
0587|211|B|||
0587|212|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0587|213|D|remember. If it is near the time of the next dose, skip the||
0587|214|D|missed dose. Take your next dose at the regular time. Do not||
0587|215|D|double the dose to catch up.||
0587|216|B|||
0587|217|R|STORAGE:  Store at room temperature away from light and moisture.||
0587|218|R|Do not store in the bathroom. Keep all medications away from||
0587|219|R|children and pets.||
0587|220|R|   Do not flush medications down the toilet or pour them into a||
0587|221|R|drain unless instructed to do so. Properly discard this product||
0587|222|R|when it is expired or no longer needed. Consult your pharmacist||
0587|223|R|or local waste disposal company.||
0587|224|B|||
0587|225|A|Information last revised March 2025.||
0587|226|A|Copyright(c) 2025 First Databank, Inc.||
0587|227|B|||
0588|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0588|002|Z|does NOT have all possible information about this product. This||
0588|003|Z|information does not assure that this product is safe, effective,||
0588|004|Z|or appropriate for you. This information is not individual||
0588|005|Z|medical advice and does not substitute for the advice of your||
0588|006|Z|health care professional. Always ask your health care||
0588|007|Z|professional for complete information about this product and your||
0588|008|Z|specific health needs.||
0588|009|B|||
0588|010|T|ALENDRONATE/VITAMIN D3 - ORAL||
0588|011|F|(a-LEN-droe-nate SOE-dee-um/VYE-ta-min)||
0588|012|B|||
0588|013|C|COMMON BRAND NAME(S): Fosamax plus D||
0588|014|B|||
0588|015|U|USES:  This medication is used to treat certain types of bone||
0588|016|U|loss (osteoporosis) and to increase bone mass. Osteoporosis||
0588|017|U|causes bones to become thinner and break more easily. Your chance||
0588|018|U|of developing osteoporosis increases as you age, after menopause,||
0588|019|U|or if you are taking corticosteroid medications (such as||
0588|020|U|prednisone) for a long time.||
0588|021|U|   This product is a combination of two medicines: alendronate||
0588|022|U|and cholecalciferol (vitamin D3). Alendronate works by slowing||
0588|023|U|bone loss to help maintain strong bones and reduce the risk of||
0588|024|U|broken bones (fractures). It belongs to a class of medications||
0588|025|U|called bisphosphonates. Vitamin D3 helps your body absorb calcium||
0588|026|U|and is necessary for building healthy bones.||
0588|027|B|||
0588|028|H|HOW TO USE:  Read the Medication Guide provided by your||
0588|029|H|pharmacist before you start taking this medication and each time||
0588|030|H|you get a refill. Follow the instructions very closely to make||
0588|031|H|sure your body absorbs as much drug as possible and to reduce the||
0588|032|H|risk of injury to your esophagus. If you have any questions, ask||
0588|033|H|your doctor or pharmacist.||
0588|034|H|   Take this medication by mouth as directed by your doctor,||
0588|035|H|usually once a week. Choose the day of the week that best fits||
0588|036|H|your schedule and take it on that day each week.||
0588|037|H|   Take this medication after getting up for the day and before||
0588|038|H|taking your first food, beverage, or other medication. Take it||
0588|039|H|with a full glass (6-8 ounces or 180-240 milliliters) of plain||
0588|040|H|water. Swallow the tablet whole. Do not chew or suck on it. Then||
0588|041|H|stay fully upright (sitting, standing, or walking) for at least||
0588|042|H|30 minutes and do not lie down until after your first food of the||
0588|043|H|day. This product works only if taken on an empty stomach. Wait||
0588|044|H|at least 30 minutes (preferably 1 to 2 hours) after taking the||
0588|045|H|medication before you eat or drink anything other than plain||
0588|046|H|water.||
0588|047|H|   Do not take this medication at bedtime or while you are still||
0588|048|H|in bed. It may not be absorbed and you may have side effects.||
0588|049|H|   Calcium or iron supplements, vitamins, antacids, coffee, tea,||
0588|050|H|soda, mineral water, juice with added calcium, and food can||
0588|051|H|decrease the absorption of alendronate. Do not take these for at||
0588|052|H|least 30 minutes (preferably 1 to 2 hours) after taking this||
0588|053|H|medication.||
0588|054|H|   Take this medication regularly to get the most benefit from||
0588|055|H|it. To help you remember, take it on the same day each week. Mark||
0588|056|H|your calendar with a reminder. Talk to your doctor about the||
0588|057|H|risks and benefits of long-term use of this medication.||
0588|058|B|||
0588|059|S|SIDE EFFECTS:  Stomach pain, constipation, diarrhea, gas, or||
0588|060|S|nausea may occur. If any of these effects last or get worse, tell||
0588|061|S|your doctor or pharmacist promptly.||
0588|062|S|   Remember that this medication has been prescribed because your||
0588|063|S|doctor has judged that the benefit to you is greater than the||
0588|064|S|risk of side effects. Many people using this medication do not||
0588|065|S|have serious side effects.||
0588|066|S|   Tell your doctor right away if you have any serious side||
0588|067|S|effects, including: jaw/ear pain, swelling of||
0588|068|S|joints/hands/ankles/feet, increased or severe bone/joint/muscle||
0588|069|S|pain, new or unusual hip/thigh/groin pain, black/tarry stools,||
0588|070|S|vomit that looks like coffee grounds.||
0588|071|S|   This medication may rarely cause serious irritation and ulcers||
0588|072|S|of the esophagus. If you notice any of the following unlikely but||
0588|073|S|very serious side effects, stop taking alendronate and talk to||
0588|074|S|your doctor or pharmacist right away: new or worsening heartburn,||
0588|075|S|chest pain, pain or difficulty when swallowing.||
0588|076|S|   A very serious allergic reaction to this drug is rare.||
0588|077|S|However, get medical help right away if you notice any symptoms||
0588|078|S|of a serious allergic reaction, including: rash, itching/swelling||
0588|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0588|080|S|breathing.||
0588|081|S|   This is not a complete list of possible side effects. If you||
0588|082|S|notice other effects not listed above, contact your doctor or||
0588|083|S|pharmacist.||
0588|084|S|   In the US -||
0588|085|S|   Call your doctor for medical advice about side effects. You||
0588|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0588|087|S|www.fda.gov/medwatch.||
0588|088|S|   In Canada - Call your doctor for medical advice about side||
0588|089|S|effects. You may report side effects to Health Canada at||
0588|090|S|1-866-234-2345.||
0588|091|B|||
0588|092|P|PRECAUTIONS:  Before taking alendronate/vitamin D3, tell your||
0588|093|P|doctor or pharmacist if you are allergic to it; or to other||
0588|094|P|bisphosphonates; or to other vitamin D products; or if you have||
0588|095|P|any other allergies. This product may contain inactive||
0588|096|P|ingredients, which can cause allergic reactions or other||
0588|097|P|problems. Talk to your pharmacist for more details.||
0588|098|P|   Before using this medication, tell your doctor or pharmacist||
0588|099|P|your medical history, especially of: disorders of the esophagus||
0588|100|P|(such as esophageal stricture or achalasia), trouble swallowing,||
0588|101|P|trouble standing or sitting upright for at least 30 minutes, low||
0588|102|P|calcium levels, kidney problems, stomach/intestinal disorders||
0588|103|P|(such as ulcers).||
0588|104|P|   Some people taking alendronate/vitamin D3 may have serious||
0588|105|P|jawbone problems. Your doctor should check your mouth before you||
0588|106|P|start this medication. Tell your dentist that you are taking this||
0588|107|P|medication before you have any dental work done. To help prevent||
0588|108|P|jawbone problems, have regular dental exams and learn how to keep||
0588|109|P|your teeth and gums healthy. If you have jaw pain, tell your||
0588|110|P|doctor and dentist right away.||
0588|111|P|   Before having any surgery (especially dental procedures), tell||
0588|112|P|your doctor and dentist about this medication and all other||
0588|113|P|products you use (including prescription drugs, nonprescription||
0588|114|P|drugs, and herbal products). Your doctor or dentist may tell you||
0588|115|P|to stop taking alendronate before your surgery. Follow all||
0588|116|P|instructions about stopping or starting this medication.||
0588|117|P|   This drug is not recommended for use in children. Studies have||
0588|118|P|shown that many children who took this drug had severe side||
0588|119|P|effects such as vomiting, fever, and flu-like symptoms.||
0588|120|P|   Tell your doctor if you are pregnant or plan to become||
0588|121|P|pregnant. Alendronate may stay in your body for many years. You||
0588|122|P|should not become pregnant while using this medication. Discuss||
0588|123|P|the risks and benefits with your doctor.||
0588|124|P|   Cholecalciferol (vitamin D3) in this medication passes into||
0588|125|P|breast milk. It is unknown if alendronate passes into breast||
0588|126|P|milk. Consult your doctor before breastfeeding.||
0588|127|B|||
0588|128|I|DRUG INTERACTIONS:  See also How to Use section.||
0588|129|I|   Drug interactions may change how your medications work or||
0588|130|I|increase your risk for serious side effects. This document does||
0588|131|I|not contain all possible drug interactions. Keep a list of all||
0588|132|I|the products you use (including prescription/nonprescription||
0588|133|I|drugs and herbal products) and share it with your doctor and||
0588|134|I|pharmacist. Do not start, stop, or change the dosage of any||
0588|135|I|medicines without your doctor's approval.||
0588|136|I|   Vitamin D3 is very similar to calcitriol. Do not use||
0588|137|I|medications containing calcitriol while using vitamin D3.||
0588|138|B|||
0588|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0588|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0588|141|O|poison control center right away. US residents can call||
0588|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0588|143|O|Symptoms of overdose may include: severe stomach pain, painful||
0588|144|O|heartburn, pain in the esophagus (chest pain), muscle||
0588|145|O|weakness/cramps, mental/mood changes, changes in the amount of||
0588|146|O|urine, vomiting.||
0588|147|B|||
0588|148|N|NOTES:  Do not share this medication with others.||
0588|149|N|   Lifestyle changes that help promote healthy bones include||
0588|150|N|increasing weight-bearing exercise, stopping smoking, limiting||
0588|151|N|alcohol, and eating well-balanced meals that contain adequate||
0588|152|N|calcium and vitamin D. You may also need to take calcium and||
0588|153|N|additional vitamin D supplements. Consult your doctor for||
0588|154|N|specific advice.||
0588|155|N|   Lab and/or medical tests (X-rays, height measurement, blood||
0588|156|N|mineral levels) should be done while you are taking this||
0588|157|N|medication. Keep all medical and lab appointments. Consult your||
0588|158|N|doctor for more details.||
0588|159|B|||
0588|160|D|MISSED DOSE:  If you miss a dose, take it the next morning after||
0588|161|D|you remember. Then go back to your weekly dosing schedule on your||
0588|162|D|usual day of the week. Do not take two doses on the same day.||
0588|163|B|||
0588|164|R|STORAGE:  Store at room temperature away from light and moisture.||
0588|165|R|Do not store in the bathroom. Keep all medications away from||
0588|166|R|children and pets.||
0588|167|R|   Do not flush medications down the toilet or pour them into a||
0588|168|R|drain unless instructed to do so. Properly discard this product||
0588|169|R|when it is expired or no longer needed. Consult your pharmacist||
0588|170|R|or local waste disposal company.||
0588|171|B|||
0588|172|A|Information last revised September 2025.||
0588|173|A|Copyright(c) 2025 First Databank, Inc.||
0588|174|B|||
0589|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0589|002|Z|does NOT have all possible information about this product. This||
0589|003|Z|information does not assure that this product is safe, effective,||
0589|004|Z|or appropriate for you. This information is not individual||
0589|005|Z|medical advice and does not substitute for the advice of your||
0589|006|Z|health care professional. Always ask your health care||
0589|007|Z|professional for complete information about this product and your||
0589|008|Z|specific health needs.||
0589|009|B|||
0589|010|T|SILDENAFIL 20 MG (LUNGS) - ORAL||
0589|011|F|(sil-DEN-a-fil)||
0589|012|B|||
0589|013|C|COMMON BRAND NAME(S): Revatio||
0589|014|B|||
0589|015|U|USES:  Sildenafil is used to treat high blood pressure in the||
0589|016|U|lungs (pulmonary hypertension). It works by relaxing and widening||
0589|017|U|the blood vessels in your lungs which allows the blood to flow||
0589|018|U|more easily. Decreasing high blood pressure in the lungs allows||
0589|019|U|your heart and lungs to work better and improves your ability to||
0589|020|U|exercise.||
0589|021|B|||
0589|022|V|OTHER USES:  This section contains uses of this drug that are not||
0589|023|V|listed in the approved professional labeling for the drug but||
0589|024|V|that may be prescribed by your health care professional. Use this||
0589|025|V|drug for a condition that is listed in this section only if it||
0589|026|V|has been so prescribed by your health care professional.||
0589|027|V|   Sildenafil is also available in other brands and other||
0589|028|V|strengths for erectile dysfunction-ED in men.||
0589|029|B|||
0589|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0589|031|H|from your pharmacist before you start taking sildenafil and each||
0589|032|H|time you get a refill. If you have any questions, ask your doctor||
0589|033|H|or pharmacist.||
0589|034|H|   To treat high blood pressure in the lungs, take this||
0589|035|H|medication by mouth with or without food as directed by your||
0589|036|H|doctor, usually 3 times a day. The dosage is based on your||
0589|037|H|medical condition, response to treatment, and other medications||
0589|038|H|you may be taking. Be sure to tell your doctor and pharmacist||
0589|039|H|about all the products you use (including prescription drugs,||
0589|040|H|nonprescription drugs, and herbal products). Children's dosage is||
0589|041|H|also based on weight.||
0589|042|H|   Do not increase your dose or take this drug more often than||
0589|043|H|prescribed. Your condition will not improve any faster, and your||
0589|044|H|risk of side effects will increase.||
0589|045|H|   Take this medication regularly to get the most benefit from||
0589|046|H|it. To help you remember, take it at the same times each day.||
0589|047|H|   Tell your doctor if your condition does not get better or if||
0589|048|H|it gets worse.||
0589|049|B|||
0589|050|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, flushing,||
0589|051|S|stomach upset, nosebleeds, trouble sleeping, or swollen||
0589|052|S|hands/ankles/feet (edema) may occur. Vision changes such as||
0589|053|S|increased sensitivity to light, blurred vision, or trouble||
0589|054|S|telling blue and green colors apart may also occur. If any of||
0589|055|S|these effects last or get worse, tell your doctor or pharmacist||
0589|056|S|promptly.||
0589|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
0589|058|S|slowly when rising from a sitting or lying position.||
0589|059|S|   Remember that this medication has been prescribed because your||
0589|060|S|doctor has judged that the benefit to you is greater than the||
0589|061|S|risk of side effects. Many people using this medication do not||
0589|062|S|have serious side effects.||
0589|063|S|   Rarely, sudden decreased vision, or even permanent blindness,||
0589|064|S|may occur in one or both eyes (NAION). If this serious problem||
0589|065|S|occurs, stop taking sildenafil and get medical help right away.||
0589|066|S|You have a slightly greater chance of developing NAION if you||
0589|067|S|have heart disease, diabetes, high cholesterol, certain other eye||
0589|068|S|problems ("crowded disk"), high blood pressure, if you are over||
0589|069|S|50, or if you smoke.||
0589|070|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
0589|071|S|ringing in the ears and dizziness, may occur. Stop taking||
0589|072|S|sildenafil and get medical help right away if these effects||
0589|073|S|occur.||
0589|074|S|   Rarely, males may have a painful or prolonged erection lasting||
0589|075|S|4 or more hours. If this occurs, stop using this drug and get||
0589|076|S|medical help right away, or permanent problems could occur.||
0589|077|S|   Get medical help right away if you have any very serious side||
0589|078|S|effects, including: increased shortness of breath or trouble||
0589|079|S|breathing, fainting.||
0589|080|S|   A very serious allergic reaction to this drug is rare.||
0589|081|S|However, get medical help right away if you notice any symptoms||
0589|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0589|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0589|084|S|breathing.||
0589|085|S|   This is not a complete list of possible side effects. If you||
0589|086|S|notice other effects not listed above, contact your doctor or||
0589|087|S|pharmacist.||
0589|088|S|   In the US -||
0589|089|S|   Call your doctor for medical advice about side effects. You||
0589|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0589|091|S|www.fda.gov/medwatch.||
0589|092|S|   In Canada - Call your doctor for medical advice about side||
0589|093|S|effects. You may report side effects to Health Canada at||
0589|094|S|1-866-234-2345.||
0589|095|B|||
0589|096|P|PRECAUTIONS:  Before taking sildenafil, tell your doctor or||
0589|097|P|pharmacist if you are allergic to it; or if you have any other||
0589|098|P|allergies. This product may contain inactive ingredients, which||
0589|099|P|can cause allergic reactions or other problems. Talk to your||
0589|100|P|pharmacist for more details.||
0589|101|P|   Before using this medication, tell your doctor or pharmacist||
0589|102|P|your medical history, especially of: heart problems (such as||
0589|103|P|heart attack or life-threatening irregular heartbeat in the past||
0589|104|P|6 months, chest pain/angina, heart failure), stroke in the past 6||
0589|105|P|months, high or low blood pressure, dehydration, penis conditions||
0589|106|P|(such as angulation, fibrosis/scarring, Peyronie's disease),||
0589|107|P|history of painful/prolonged erection (priapism), conditions that||
0589|108|P|may increase the risk of priapism (such as sickle cell anemia,||
0589|109|P|leukemia, multiple myeloma), eye problems (such as retinitis||
0589|110|P|pigmentosa, sudden decreased vision, NAION), other lung||
0589|111|P|conditions (such as pulmonary veno-occlusive disease).||
0589|112|P|   This drug may make you dizzy or cause vision problems. Alcohol||
0589|113|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
0589|114|P|use machinery, or do anything that needs alertness or clear||
0589|115|P|vision until you can do it safely. Limit alcoholic beverages.||
0589|116|P|Talk to your doctor if you are using marijuana (cannabis).||
0589|117|P|   Before having surgery, tell your doctor or dentist about all||
0589|118|P|the products you use (including prescription drugs,||
0589|119|P|nonprescription drugs, and herbal products).||
0589|120|P|   During pregnancy, sildenafil should be used only when clearly||
0589|121|P|needed. Since high blood pressure in the lungs is a serious||
0589|122|P|condition that can harm both a pregnant woman and her unborn||
0589|123|P|baby, do not stop taking this medication unless directed by your||
0589|124|P|doctor. If you are planning pregnancy, become pregnant, or think||
0589|125|P|you may be pregnant, discuss with your doctor right away the||
0589|126|P|benefits and risks of using this medication during pregnancy.||
0589|127|P|   This medication passes into breast milk. Consult your doctor||
0589|128|P|before breastfeeding.||
0589|129|B|||
0589|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0589|131|I|medications work or increase your risk for serious side effects.||
0589|132|I|This document does not contain all possible drug interactions.||
0589|133|I|Keep a list of all the products you use (including||
0589|134|I|prescription/nonprescription drugs and herbal products) and share||
0589|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
0589|136|I|the dosage of any medicines without your doctor's approval.||
0589|137|I|   Some products that may interact with this drug are: riociguat,||
0589|138|I|vericiguat.||
0589|139|I|   Sildenafil can cause a serious drop in your blood pressure||
0589|140|I|when used with nitrates. A serious drop in blood pressure can||
0589|141|I|lead to dizziness, fainting, and rarely heart attack or stroke.||
0589|142|I|Do not use sildenafil with any of the following: certain drugs||
0589|143|I|used to treat chest pain/angina (nitrates such as nitroglycerin,||
0589|144|I|isosorbide), recreational drugs called "poppers" containing amyl||
0589|145|I|or butyl nitrite.||
0589|146|I|   If you are also taking an alpha blocker medication (such as||
0589|147|I|doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high||
0589|148|I|blood pressure, your blood pressure may get too low which can||
0589|149|I|lead to dizziness or fainting. Your doctor may adjust your||
0589|150|I|medications to minimize your risk of low blood pressure.||
0589|151|I|   Other medications can affect the removal of sildenafil from||
0589|152|I|your body, which may affect how sildenafil works. Examples||
0589|153|I|include azole antifungals (such as itraconazole, ketoconazole),||
0589|154|I|cobicistat, macrolide antibiotics (such as clarithromycin,||
0589|155|I|erythromycin), mifepristone, HIV protease inhibitors (such as||
0589|156|I|atazanavir, darunavir), rifampin, ritonavir, among others.||
0589|157|I|   Do not take this medication with any other product that||
0589|158|I|contains sildenafil or other similar medications for erectile||
0589|159|I|dysfunction-ED or pulmonary hypertension (such as tadalafil,||
0589|160|I|vardenafil).||
0589|161|B|||
0589|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0589|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0589|164|O|poison control center right away. US residents can call||
0589|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0589|166|O|Symptoms of overdose may include: severe dizziness, fainting,||
0589|167|O|painful/prolonged erection.||
0589|168|B|||
0589|169|N|NOTES:  Do not share this medication with others.||
0589|170|N|   Lab and/or medical tests (such as eye exams, blood pressure)||
0589|171|N|may be done while you are taking this medication. Keep all||
0589|172|N|medical and lab appointments. Consult your doctor for more||
0589|173|N|details.||
0589|174|B|||
0589|175|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0589|176|D|remember. If it is near the time of the next dose, skip the||
0589|177|D|missed dose. Take your next dose at the regular time. Do not||
0589|178|D|double the dose to catch up.||
0589|179|B|||
0589|180|R|STORAGE:  Store at room temperature away from light and moisture.||
0589|181|R|Do not store in the bathroom. Keep all medications away from||
0589|182|R|children and pets.||
0589|183|R|   Do not flush medications down the toilet or pour them into a||
0589|184|R|drain unless instructed to do so. Properly discard this product||
0589|185|R|when it is expired or no longer needed. Consult your pharmacist||
0589|186|R|or local waste disposal company.||
0589|187|B|||
0589|188|A|Information last revised February 2025.||
0589|189|A|Copyright(c) 2025 First Databank, Inc.||
0589|190|B|||
0592|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0592|002|Z|does NOT have all possible information about this product. This||
0592|003|Z|information does not assure that this product is safe, effective,||
0592|004|Z|or appropriate for you. This information is not individual||
0592|005|Z|medical advice and does not substitute for the advice of your||
0592|006|Z|health care professional. Always ask your health care||
0592|007|Z|professional for complete information about this product and your||
0592|008|Z|specific health needs.||
0592|009|B|||
0592|010|T|ECONAZOLE CREAM - TOPICAL||
0592|011|F|(e-KON-a-zole)||
0592|012|B|||
0592|013|C|COMMON BRAND NAME(S): Spectazole||
0592|014|B|||
0592|015|U|USES:  Econazole is used to treat a variety of fungal skin||
0592|016|U|infections such as athlete's foot, jock itch, and ringworm. This||
0592|017|U|medication is also used to treat a skin condition known as||
0592|018|U|pityriasis (tinea versicolor), a fungal infection that causes a||
0592|019|U|lightening or darkening of the skin of the neck, chest, arms, or||
0592|020|U|legs. Econazole is an azole antifungal that works by preventing||
0592|021|U|the growth of fungus.||
0592|022|B|||
0592|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0592|024|H|thoroughly dry the area to be treated. Apply this medication on||
0592|025|H|and around the affected area as directed by your doctor, usually||
0592|026|H|once or twice a day. The dosage and length of treatment depend on||
0592|027|H|the type of infection being treated. Do not apply this medication||
0592|028|H|more often or use for longer than prescribed.||
0592|029|H|   Wash your hands after using unless the area being treated||
0592|030|H|includes the hands. Do not wrap, cover, or bandage the area||
0592|031|H|unless directed to do so by your doctor.||
0592|032|H|   Do not apply this medication in the eyes, nose, or mouth, or||
0592|033|H|inside the vagina. If you do get the medication in those areas,||
0592|034|H|flush with plenty of water.||
0592|035|H|   Use this medication regularly to get the most benefit from it.||
0592|036|H|To help you remember, use it at the same time(s) each day.||
0592|037|H|   Continue to use this medication until the full prescribed||
0592|038|H|amount is finished, even if symptoms disappear after a few days.||
0592|039|H|Stopping the medication too early may result in a return of the||
0592|040|H|infection.||
0592|041|H|   Tell your doctor if your condition lasts after 2 weeks of||
0592|042|H|treatment (or after 4 weeks of treatment for athlete's foot) or||
0592|043|H|if it gets worse.||
0592|044|B|||
0592|045|S|SIDE EFFECTS:  Burning, stinging, irritation, or redness at the||
0592|046|S|application site may occur. If any of these effects last or get||
0592|047|S|worse, tell your doctor or pharmacist promptly.||
0592|048|S|   Remember that this medication has been prescribed because your||
0592|049|S|doctor has judged that the benefit to you is greater than the||
0592|050|S|risk of side effects. Many people using this medication do not||
0592|051|S|have serious side effects.||
0592|052|S|   A very serious allergic reaction to this drug is rare.||
0592|053|S|However, get medical help right away if you notice any symptoms||
0592|054|S|of a serious allergic reaction, including: rash, itching/swelling||
0592|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0592|056|S|breathing.||
0592|057|S|   This is not a complete list of possible side effects. If you||
0592|058|S|notice other effects not listed above, contact your doctor or||
0592|059|S|pharmacist.||
0592|060|S|   In the US -||
0592|061|S|   Call your doctor for medical advice about side effects. You||
0592|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0592|063|S|www.fda.gov/medwatch.||
0592|064|S|   In Canada - Call your doctor for medical advice about side||
0592|065|S|effects. You may report side effects to Health Canada at||
0592|066|S|1-866-234-2345.||
0592|067|B|||
0592|068|P|PRECAUTIONS:  Before using econazole, tell your doctor or||
0592|069|P|pharmacist if you are allergic to it; or to other azole||
0592|070|P|antifungals (such as clotrimazole, ketoconazole, miconazole); or||
0592|071|P|if you have any other allergies. This product may contain||
0592|072|P|inactive ingredients, which can cause allergic reactions or other||
0592|073|P|problems. Talk to your pharmacist for more details.||
0592|074|P|   Before using this medication, tell your doctor or pharmacist||
0592|075|P|your medical history.||
0592|076|P|   Before having surgery, tell your doctor or dentist about all||
0592|077|P|the products you use (including prescription drugs,||
0592|078|P|nonprescription drugs, and herbal products).||
0592|079|P|   During pregnancy, this medication should be used only when||
0592|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
0592|081|P|   It is unknown if this drug passes into breast milk. Consult||
0592|082|P|your doctor before breastfeeding.||
0592|083|B|||
0592|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0592|085|I|medications work or increase your risk for serious side effects.||
0592|086|I|This document does not contain all possible drug interactions.||
0592|087|I|Keep a list of all the products you use (including||
0592|088|I|prescription/nonprescription drugs and herbal products) and share||
0592|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
0592|090|I|the dosage of any medicines without your doctor's approval.||
0592|091|B|||
0592|092|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0592|093|O|has overdosed and has serious symptoms such as passing out or||
0592|094|O|trouble breathing, call 911. Otherwise, call a poison control||
0592|095|O|center right away. US residents can call 1-800-222-1222. Canada||
0592|096|O|residents can call 1-844-764-7669.||
0592|097|B|||
0592|098|N|NOTES:  Do not share this medication with others.||
0592|099|N|   This medication has been prescribed for your current condition||
0592|100|N|only. Do not use it later for another infection unless your||
0592|101|N|doctor tells you to.||
0592|102|N|   When treating pityriasis, this medication may not cause a||
0592|103|N|return to normal skin color right away. It may take several||
0592|104|N|months after treatment is completed for your natural skin color||
0592|105|N|to return.||
0592|106|B|||
0592|107|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0592|108|D|If it is near the time of the next dose, skip the missed dose.||
0592|109|D|Use your next dose at the regular time. Do not double the dose to||
0592|110|D|catch up.||
0592|111|B|||
0592|112|R|STORAGE:  Store at room temperature. Keep all medications away||
0592|113|R|from children and pets.||
0592|114|R|   Do not flush medications down the toilet or pour them into a||
0592|115|R|drain unless instructed to do so. Properly discard this product||
0592|116|R|when it is expired or no longer needed. Consult your pharmacist||
0592|117|R|or local waste disposal company.||
0592|118|B|||
0592|119|A|Information last revised May 2024.||
0592|120|A|Copyright(c) 2025 First Databank, Inc.||
0592|121|B|||
0593|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0593|002|Z|does NOT have all possible information about this product. This||
0593|003|Z|information does not assure that this product is safe, effective,||
0593|004|Z|or appropriate for you. This information is not individual||
0593|005|Z|medical advice and does not substitute for the advice of your||
0593|006|Z|health care professional. Always ask your health care||
0593|007|Z|professional for complete information about this product and your||
0593|008|Z|specific health needs.||
0593|009|B|||
0593|010|T|SULCONAZOLE CREAM - TOPICAL||
0593|011|F|(sul-KON-a-zole)||
0593|012|B|||
0593|013|C|COMMON BRAND NAME(S): Exelderm||
0593|014|B|||
0593|015|U|USES:  Sulconazole is used to treat skin infections such as||
0593|016|U|athlete's foot, jock itch and ringworm. This medication is also||
0593|017|U|used to treat a skin condition known as pityriasis (tinea||
0593|018|U|versicolor), a fungal infection that causes a lightening or||
0593|019|U|darkening of the skin of the neck, chest, arms, or legs.||
0593|020|U|Sulconazole is an azole antifungal that works by preventing the||
0593|021|U|growth of fungus.||
0593|022|B|||
0593|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0593|024|H|thoroughly dry the area to be treated. Apply this medication to||
0593|025|H|the affected skin as directed by your doctor, usually once or||
0593|026|H|twice a day. The dosage and length of treatment depends on the||
0593|027|H|type of infection being treated. Do not apply this more often||
0593|028|H|than prescribed. Your condition will not clear faster, but side||
0593|029|H|effects may be increased.||
0593|030|H|   Apply enough cream to cover the affected area and some of the||
0593|031|H|surrounding skin. After applying this medication, wash your||
0593|032|H|hands. Do not wrap, cover or bandage the area unless directed to||
0593|033|H|do so by your doctor.||
0593|034|H|   Do not apply this medication in the eyes, nose, mouth, or||
0593|035|H|vagina.||
0593|036|H|   Use this medication regularly in order to get the most benefit||
0593|037|H|from it. Remember to use it at the same time(s) each day.||
0593|038|H|   Continue to use this medication until the full prescribed||
0593|039|H|amount is finished, even if symptoms disappear after a few days.||
0593|040|H|Stopping the medication too early may result in a return of the||
0593|041|H|infection.||
0593|042|H|   Tell your doctor if your condition lasts after 4 to 6 weeks of||
0593|043|H|treatment or gets worse at any time.||
0593|044|B|||
0593|045|S|SIDE EFFECTS:  Burning, stinging, swelling, irritation, redness,||
0593|046|S|pimple-like bumps, tenderness, or flaking of the treated skin may||
0593|047|S|occur. If any of these effects last or get worse, notify your||
0593|048|S|doctor or pharmacist promptly.||
0593|049|S|   Remember that this medication has been prescribed because your||
0593|050|S|doctor has judged that the benefit to you is greater than the||
0593|051|S|risk of side effects. Many people using this medication do not||
0593|052|S|have serious side effects.||
0593|053|S|   Tell your doctor right away if you have any serious side||
0593|054|S|effects, including: blistering, oozing, open sores.||
0593|055|S|   A very serious allergic reaction to this drug is rare.||
0593|056|S|However, get medical help right away if you notice any symptoms||
0593|057|S|of a serious allergic reaction, including: rash, itching/swelling||
0593|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0593|059|S|breathing.||
0593|060|S|   This is not a complete list of possible side effects. If you||
0593|061|S|notice other effects not listed above, contact your doctor or||
0593|062|S|pharmacist.||
0593|063|S|   In the US -||
0593|064|S|   Call your doctor for medical advice about side effects. You||
0593|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0593|066|S|www.fda.gov/medwatch.||
0593|067|S|   In Canada - Call your doctor for medical advice about side||
0593|068|S|effects. You may report side effects to Health Canada at||
0593|069|S|1-866-234-2345.||
0593|070|B|||
0593|071|P|PRECAUTIONS:  Before using sulconazole, tell your doctor or||
0593|072|P|pharmacist if you are allergic to it; or to other azole||
0593|073|P|antifungals such as clotrimazole, ketoconazole, or miconazole; or||
0593|074|P|if you have any other allergies. This product may contain||
0593|075|P|inactive ingredients, which can cause allergic reactions or other||
0593|076|P|problems. Talk to your pharmacist for more details.||
0593|077|P|   Before using this medication, tell your doctor or pharmacist||
0593|078|P|your medical history.||
0593|079|P|   Before having surgery, tell your doctor or dentist about all||
0593|080|P|the products you use (including prescription drugs,||
0593|081|P|nonprescription drugs, and herbal products).||
0593|082|P|   During pregnancy, this medication should be used only when||
0593|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
0593|084|P|   It is unknown if this drug passes into breast milk. Consult||
0593|085|P|your doctor before breastfeeding.||
0593|086|B|||
0593|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0593|088|I|medications work or increase your risk for serious side effects.||
0593|089|I|This document does not contain all possible drug interactions.||
0593|090|I|Keep a list of all the products you use (including||
0593|091|I|prescription/nonprescription drugs and herbal products) and share||
0593|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
0593|093|I|the dosage of any medicines without your doctor's approval.||
0593|094|B|||
0593|095|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0593|096|O|has overdosed and has serious symptoms such as passing out or||
0593|097|O|trouble breathing, call 911. Otherwise, call a poison control||
0593|098|O|center right away. US residents can call 1-800-222-1222. Canada||
0593|099|O|residents can call 1-844-764-7669.||
0593|100|B|||
0593|101|N|NOTES:  Do not share this medication with others.||
0593|102|N|   This medication has been prescribed for your current condition||
0593|103|N|only. Do not use it later for another infection unless your||
0593|104|N|doctor tells you to.||
0593|105|N|   When treating pityriasis, this medication may not cause an||
0593|106|N|immediate return to normal skin color. It may take several months||
0593|107|N|after treatment is completed for your natural skin color to||
0593|108|N|return.||
0593|109|B|||
0593|110|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0593|111|D|If it is near the time of the next dose, skip the missed dose.||
0593|112|D|Use your next dose at the regular time. Do not double the dose to||
0593|113|D|catch up.||
0593|114|B|||
0593|115|R|STORAGE:  Store at room temperature away from high heat. Keep all||
0593|116|R|medications away from children and pets.||
0593|117|R|   Do not flush medications down the toilet or pour them into a||
0593|118|R|drain unless instructed to do so. Properly discard this product||
0593|119|R|when it is expired or no longer needed. Consult your pharmacist||
0593|120|R|or local waste disposal company.||
0593|121|B|||
0593|122|A|Information last revised October 2024.||
0593|123|A|Copyright(c) 2025 First Databank, Inc.||
0593|124|B|||
0596|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0596|002|Z|does NOT have all possible information about this product. This||
0596|003|Z|information does not assure that this product is safe, effective,||
0596|004|Z|or appropriate for you. This information is not individual||
0596|005|Z|medical advice and does not substitute for the advice of your||
0596|006|Z|health care professional. Always ask your health care||
0596|007|Z|professional for complete information about this product and your||
0596|008|Z|specific health needs.||
0596|009|B|||
0596|010|T|SULCONAZOLE SOLUTION - TOPICAL||
0596|011|F|(sul-KONE-a-zole)||
0596|012|B|||
0596|013|C|COMMON BRAND NAME(S): Exelderm||
0596|014|B|||
0596|015|U|USES:  Sulconazole is used to treat skin infections such as jock||
0596|016|U|itch and ringworm. This medication is also used to treat a skin||
0596|017|U|condition known as pityriasis (tinea versicolor), a fungal||
0596|018|U|infection that causes a lightening or darkening of the skin of||
0596|019|U|the neck, chest, arms, or legs. Sulconazole is an azole||
0596|020|U|antifungal that works by preventing the growth of fungus.||
0596|021|B|||
0596|022|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0596|023|H|thoroughly dry the area to be treated. Apply this medication to||
0596|024|H|the affected skin as directed by your doctor, usually once or||
0596|025|H|twice a day. The dosage and length of treatment depends on the||
0596|026|H|type of infection being treated. Do not apply this more often||
0596|027|H|than prescribed. Your condition will not clear faster, but side||
0596|028|H|effects may be increased.||
0596|029|H|   Apply enough medication to cover the affected area and some of||
0596|030|H|the surrounding skin. After applying this medication, wash your||
0596|031|H|hands. Do not wrap, cover or bandage the area unless directed to||
0596|032|H|do so by your doctor.||
0596|033|H|   Do not apply this medication in the eyes, nose, mouth, or||
0596|034|H|vagina.||
0596|035|H|   Use this medication regularly in order to get the most benefit||
0596|036|H|from it. Remember to use it at the same time(s) each day.||
0596|037|H|   Continue to use this medication until the full prescribed||
0596|038|H|amount is finished, even if symptoms disappear after a few days.||
0596|039|H|Stopping the medication too early may result in a return of the||
0596|040|H|infection.||
0596|041|H|   Tell your doctor if your condition lasts after 4 weeks of||
0596|042|H|treatment or gets worse at any time.||
0596|043|B|||
0596|044|S|SIDE EFFECTS:  Burning, stinging, swelling, irritation, redness,||
0596|045|S|pimple-like bumps, tenderness, or flaking of the treated skin may||
0596|046|S|occur. If any of these effects last or get worse, notify your||
0596|047|S|doctor or pharmacist promptly.||
0596|048|S|   Remember that this medication has been prescribed because your||
0596|049|S|doctor has judged that the benefit to you is greater than the||
0596|050|S|risk of side effects. Many people using this medication do not||
0596|051|S|have serious side effects.||
0596|052|S|   Tell your doctor right away if you have any serious side||
0596|053|S|effects, including: blistering, oozing, open sores.||
0596|054|S|   A very serious allergic reaction to this drug is rare.||
0596|055|S|However, get medical help right away if you notice any symptoms||
0596|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0596|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0596|058|S|breathing.||
0596|059|S|   This is not a complete list of possible side effects. If you||
0596|060|S|notice other effects not listed above, contact your doctor or||
0596|061|S|pharmacist.||
0596|062|S|   In the US -||
0596|063|S|   Call your doctor for medical advice about side effects. You||
0596|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0596|065|S|www.fda.gov/medwatch.||
0596|066|S|   In Canada - Call your doctor for medical advice about side||
0596|067|S|effects. You may report side effects to Health Canada at||
0596|068|S|1-866-234-2345.||
0596|069|B|||
0596|070|P|PRECAUTIONS:  Before using sulconazole, tell your doctor or||
0596|071|P|pharmacist if you are allergic to it; or to other azole||
0596|072|P|antifungals such as clotrimazole, ketoconazole, or miconazole; or||
0596|073|P|if you have any other allergies. This product may contain||
0596|074|P|inactive ingredients, which can cause allergic reactions or other||
0596|075|P|problems. Talk to your pharmacist for more details.||
0596|076|P|   Before using this medication, tell your doctor or pharmacist||
0596|077|P|your medical history.||
0596|078|P|   Before having surgery, tell your doctor or dentist about all||
0596|079|P|the products you use (including prescription drugs,||
0596|080|P|nonprescription drugs, and herbal products).||
0596|081|P|   During pregnancy, this medication should be used only when||
0596|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
0596|083|P|   It is unknown if this drug passes into breast milk. Consult||
0596|084|P|your doctor before breastfeeding.||
0596|085|B|||
0596|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0596|087|I|medications work or increase your risk for serious side effects.||
0596|088|I|This document does not contain all possible drug interactions.||
0596|089|I|Keep a list of all the products you use (including||
0596|090|I|prescription/nonprescription drugs and herbal products) and share||
0596|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
0596|092|I|the dosage of any medicines without your doctor's approval.||
0596|093|B|||
0596|094|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0596|095|O|has overdosed and has serious symptoms such as passing out or||
0596|096|O|trouble breathing, call 911. Otherwise, call a poison control||
0596|097|O|center right away. US residents can call 1-800-222-1222. Canada||
0596|098|O|residents can call 1-844-764-7669.||
0596|099|B|||
0596|100|N|NOTES:  Do not share this medication with others.||
0596|101|N|   This medication has been prescribed for your current condition||
0596|102|N|only. Do not use it later for another infection unless your||
0596|103|N|doctor tells you to.||
0596|104|N|   When treating pityriasis, this medication may not cause an||
0596|105|N|immediate return to normal skin color. It may take several months||
0596|106|N|after treatment is completed for your natural skin color to||
0596|107|N|return.||
0596|108|B|||
0596|109|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0596|110|D|If it is near the time of the next dose, skip the missed dose.||
0596|111|D|Use your next dose at the regular time. Do not double the dose to||
0596|112|D|catch up.||
0596|113|B|||
0596|114|R|STORAGE:  Store at room temperature away from high heat and||
0596|115|R|light. Keep all medications away from children and pets.||
0596|116|R|   Do not flush medications down the toilet or pour them into a||
0596|117|R|drain unless instructed to do so. Properly discard this product||
0596|118|R|when it is expired or no longer needed. Consult your pharmacist||
0596|119|R|or local waste disposal company.||
0596|120|B|||
0596|121|A|Information last revised October 2024.||
0596|122|A|Copyright(c) 2025 First Databank, Inc.||
0596|123|B|||
0598|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0598|002|Z|does NOT have all possible information about this product. This||
0598|003|Z|information does not assure that this product is safe, effective,||
0598|004|Z|or appropriate for you. This information is not individual||
0598|005|Z|medical advice and does not substitute for the advice of your||
0598|006|Z|health care professional. Always ask your health care||
0598|007|Z|professional for complete information about this product and your||
0598|008|Z|specific health needs.||
0598|009|B|||
0598|010|T|POLYETHYLENE GLYCOL (PEG) 3350 W/ ELECTROLYTE AND BISACODYL-ORAL||
0598|011|F|(pol-ee-ETH-i-leen GLYE-kole/ee-LECK-tro-lite and bis-a-KOE-dil)||
0598|012|B|||
0598|013|C|COMMON BRAND NAME(S): HalfLytely||
0598|014|B|||
0598|015|U|USES:  This medication is used to clean the intestine to prepare||
0598|016|U|you for rectal or bowel examinations.||
0598|017|U|   This product is a combination of two laxatives, bisacodyl and||
0598|018|U|PEG with electrolyte. Bisacodyl works directly on the large||
0598|019|U|intestine to make you have bowel movements. It is known as a||
0598|020|U|stimulant-type laxative. PEG with electrolyte works by holding||
0598|021|U|water in the stool to cause watery bowel movements. It is known||
0598|022|U|as an osmotic-type laxative.||
0598|023|B|||
0598|024|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0598|025|H|Patient Information Leaflet provided by your pharmacist before||
0598|026|H|you start taking this medication and each time you get a refill.||
0598|027|H|If you have any questions, ask your doctor or pharmacist.||
0598|028|H|   Take this product by mouth exactly as directed by your doctor.||
0598|029|H|Do not take antacids for at least one hour before starting this||
0598|030|H|product. Take the prescribed number of bisacodyl tablets with||
0598|031|H|water before using the PEG with electrolyte oral solution. Do not||
0598|032|H|chew or crush the tablets. You should have a bowel movement||
0598|033|H|usually within 1 to 6 hours after taking bisacodyl. After you||
0598|034|H|have your first bowel movement or after waiting for a maximum of||
0598|035|H|6 hours, begin drinking the PEG with electrolyte oral solution.||
0598|036|H|   The PEG with electrolyte powder must be mixed with water||
0598|037|H|before use. Follow the instructions provided with the product or||
0598|038|H|as directed by your doctor or pharmacist. Fill the container with||
0598|039|H|the correct amount of water, cap the bottle, and shake well to||
0598|040|H|make sure the powder dissolves completely. Drink one full glass||
0598|041|H|(8 ounces or 240 milliliters) of the solution every 10 minutes||
0598|042|H|until you finish the total amount prescribed by your doctor.||
0598|043|H|Rapid drinking of each glassful is preferred to drinking small||
0598|044|H|amounts continuously. Do not save any unused solution for future||
0598|045|H|use. Ask your doctor or pharmacist if you have any questions||
0598|046|H|about how to use this product.||
0598|047|H|   PEG with electrolyte may cause certain liquid thickeners||
0598|048|H|(starch-based products) to not work well, which may increase the||
0598|049|H|risk of choking. If you are using liquid thickeners with this||
0598|050|H|medication, talk to your pharmacist to select a liquid thickener||
0598|051|H|which will not interact with this medication.||
0598|052|H|   If severe bloating or abdominal pain occurs, drink the||
0598|053|H|solution more slowly or temporarily stop drinking the solution||
0598|054|H|until the symptoms improve.||
0598|055|H|   Do not take any other medication by mouth within 1 to 2 hours||
0598|056|H|of starting this product since the other medication may not be||
0598|057|H|absorbed. Talk to your doctor or pharmacist about rescheduling||
0598|058|H|your other medications while you are taking this product.||
0598|059|H|   Be sure to follow your doctor's instructions about your diet||
0598|060|H|before starting this product, while you are taking it, and after||
0598|061|H|you finish the product. It is usually recommended that you drink||
0598|062|H|only clear liquids and do not eat any solid food when you are||
0598|063|H|preparing for your bowel examination. Drink plenty of clear||
0598|064|H|liquids as directed by your doctor to prevent dehydration. Ask||
0598|065|H|your doctor or pharmacist if you have any questions.||
0598|066|B|||
0598|067|S|SIDE EFFECTS:  Nausea, stomach fullness, cramping, or vomiting||
0598|068|S|may occur. These effects are usually temporary. If any of these||
0598|069|S|effects last or get worse, notify your doctor or pharmacist||
0598|070|S|promptly.||
0598|071|S|   Remember that this medication has been prescribed because your||
0598|072|S|doctor has judged that the benefit to you is greater than the||
0598|073|S|risk of side effects. Many people using this medication do not||
0598|074|S|have serious side effects.||
0598|075|S|   Vomiting that doesn't stop may result in dehydration. Contact||
0598|076|S|your doctor promptly if you notice any symptoms of dehydration,||
0598|077|S|such as unusual dry mouth/thirst, fast heartbeat, or||
0598|078|S|dizziness/lightheadedness.||
0598|079|S|   Tell your doctor right away if you have any serious side||
0598|080|S|effects, including: nausea/vomiting that is severe or doesn't||
0598|081|S|stop, stomach/abdominal pain that is severe or doesn't go away,||
0598|082|S|vomit that is bloody or looks like coffee grounds, bloody stools,||
0598|083|S|rectal bleeding, slowed heartbeat, muscle weakness, seizures,||
0598|084|S|signs of kidney problems (such as change in the amount of urine).||
0598|085|S|   A very serious allergic reaction to this drug is rare.||
0598|086|S|However, get medical help right away if you notice any symptoms||
0598|087|S|of a serious allergic reaction, including: rash, itching/swelling||
0598|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0598|089|S|breathing.||
0598|090|S|   This is not a complete list of possible side effects. If you||
0598|091|S|notice other effects not listed above, contact your doctor or||
0598|092|S|pharmacist.||
0598|093|S|   In the US -||
0598|094|S|   Call your doctor for medical advice about side effects. You||
0598|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0598|096|S|www.fda.gov/medwatch.||
0598|097|S|   In Canada - Call your doctor for medical advice about side||
0598|098|S|effects. You may report side effects to Health Canada at||
0598|099|S|1-866-234-2345.||
0598|100|B|||
0598|101|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0598|102|P|pharmacist if you are allergic to polyethylene glycol; or to||
0598|103|P|bisacodyl; or if you have any other allergies. This product may||
0598|104|P|contain inactive ingredients, which can cause allergic reactions||
0598|105|P|or other problems. Talk to your pharmacist for more details.||
0598|106|P|   Before using this medication, tell your doctor or pharmacist||
0598|107|P|your medical history, especially of: nausea/vomiting/abdominal||
0598|108|P|pain that doesn't go away, certain stomach/intestinal disorders||
0598|109|P|(such as ileus, gastric retention, bowel obstruction or||
0598|110|P|perforation, ulcerative colitis, toxic colitis or megacolon),||
0598|111|P|problems with the esophagus (such as esophagitis), certain heart||
0598|112|P|diseases (such as abnormal heart rhythms, heart failure), kidney||
0598|113|P|disease, mineral imbalances, seizures, dehydration, swallowing||
0598|114|P|problems (such as dysphagia, history of aspiration).||
0598|115|P|   If you have a history of breathing food/liquids into the lungs||
0598|116|P|(aspiration) or trouble keeping food down (regurgitation), you||
0598|117|P|may need to be monitored by a health care professional when you||
0598|118|P|take this medication. Ask your doctor for more information.||
0598|119|P|   Older adults may be more sensitive to the side effects of this||
0598|120|P|drug.||
0598|121|P|   During pregnancy, this product should be used only when||
0598|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
0598|123|P|   It is unknown if this product passes into breast milk. Consult||
0598|124|P|your doctor before breastfeeding.||
0598|125|B|||
0598|126|I|DRUG INTERACTIONS:  See also the How to Use section.||
0598|127|I|   Drug interactions may change how your medications work or||
0598|128|I|increase your risk for serious side effects. This document does||
0598|129|I|not contain all possible drug interactions. Keep a list of all||
0598|130|I|the products you use (including prescription/nonprescription||
0598|131|I|drugs and herbal products) and share it with your doctor and||
0598|132|I|pharmacist. Do not start, stop, or change the dosage of any||
0598|133|I|medicines without your doctor's approval.||
0598|134|I|   Do not use other laxatives while taking this product.||
0598|135|B|||
0598|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0598|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0598|138|O|poison control center right away. US residents can call||
0598|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0598|140|B|||
0598|141|N|NOTES:  Do not share this medication with others.||
0598|142|N|   Keep all medical and lab appointments. Consult your doctor for||
0598|143|N|more details.||
0598|144|B|||
0598|145|D|MISSED DOSE:  If you forget to take this medication when directed||
0598|146|D|or remember too late to finish it, call your doctor for||
0598|147|D|instructions.||
0598|148|B|||
0598|149|R|STORAGE:  Store at room temperature away from light and moisture.||
0598|150|R|After the oral solution is mixed, refrigerate it and use within||
0598|151|R|48 hours. Do not store in the bathroom. Keep all medications away||
0598|152|R|from children and pets.||
0598|153|R|   Do not flush medications down the toilet or pour them into a||
0598|154|R|drain unless instructed to do so. Properly discard this product||
0598|155|R|when it is expired or no longer needed. Consult your pharmacist||
0598|156|R|or local waste disposal company.||
0598|157|B|||
0598|158|A|Information last revised January 2025.||
0598|159|A|Copyright(c) 2025 First Databank, Inc.||
0598|160|B|||
0599|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0599|002|Z|does NOT have all possible information about this product. This||
0599|003|Z|information does not assure that this product is safe, effective,||
0599|004|Z|or appropriate for you. This information is not individual||
0599|005|Z|medical advice and does not substitute for the advice of your||
0599|006|Z|health care professional. Always ask your health care||
0599|007|Z|professional for complete information about this product and your||
0599|008|Z|specific health needs.||
0599|009|B|||
0599|010|T|PERINDOPRIL/INDAPAMIDE - ORAL||
0599|011|F|(per-IN-doe-pril/in-DAP-a-mide)||
0599|012|B|||
0599|013|W|WARNING:  Perindopril can cause serious (possibly fatal) harm to||
0599|014|W|an unborn baby if used during pregnancy. It is important to||
0599|015|W|prevent pregnancy while taking this product. Consult your doctor||
0599|016|W|for more details and to discuss the use of reliable forms of||
0599|017|W|birth control while taking this product. If you are planning||
0599|018|W|pregnancy, become pregnant, or think you may be pregnant, tell||
0599|019|W|your doctor right away.||
0599|020|B|||
0599|021|U|USES:  This product is used to treat high blood pressure.||
0599|022|U|Lowering high blood pressure helps prevent strokes, heart||
0599|023|U|attacks, and kidney problems.||
0599|024|U|   This product contains 2 medications: perindopril and||
0599|025|U|indapamide. Perindopril belongs to a class of drugs known as ACE||
0599|026|U|inhibitors and works by relaxing blood vessels so blood can flow||
0599|027|U|more easily. Indapamide belongs to a class of drugs known as||
0599|028|U|diuretics/"water pills." It works by causing you to make more||
0599|029|U|urine. This helps your body get rid of extra salt and water.||
0599|030|B|||
0599|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0599|032|H|from your pharmacist before you start taking||
0599|033|H|perindopril/indapamide and each time you get a refill. If you||
0599|034|H|have any questions, ask your doctor or pharmacist.||
0599|035|H|   Take this medication by mouth as directed by your doctor,||
0599|036|H|usually once daily in the morning. If you take this drug too||
0599|037|H|close to bedtime, you may need to wake up to urinate. It is best||
0599|038|H|to take this medication at least 4 hours before your bedtime.||
0599|039|H|   The dosage is based on your medical condition and response to||
0599|040|H|treatment.||
0599|041|H|   Take this medication regularly to get the most benefit from||
0599|042|H|it. To help you remember, take it at the same time each day. Keep||
0599|043|H|taking this medication even if you feel well. Most people with||
0599|044|H|high blood pressure do not feel sick.||
0599|045|H|   It may take several weeks before you get the full benefit of||
0599|046|H|this product.||
0599|047|H|   If you also take certain drugs to lower your cholesterol (bile||
0599|048|H|acid-binding resins such as cholestyramine or colestipol), take||
0599|049|H|this product at least 4 hours before or at least 4 hours after||
0599|050|H|these medications.||
0599|051|H|   Tell your doctor if your condition does not get better or if||
0599|052|H|it gets worse (your blood pressure readings remain high or||
0599|053|H|increase).||
0599|054|B|||
0599|055|S|SIDE EFFECTS:  Tiredness, headache, dizziness, or lightheadedness||
0599|056|S|may occur as your body adjusts to the medication. Nausea or dry||
0599|057|S|cough may also occur. If any of these effects last or get worse,||
0599|058|S|tell your doctor or pharmacist promptly.||
0599|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
0599|060|S|slowly when rising from a sitting or lying position.||
0599|061|S|   Remember that this medication has been prescribed because your||
0599|062|S|doctor has judged that the benefit to you is greater than the||
0599|063|S|risk of side effects. Many people using this medication do not||
0599|064|S|have serious side effects.||
0599|065|S|   This product may cause dehydration and electrolyte imbalance.||
0599|066|S|Tell your doctor right away if you have any symptoms of||
0599|067|S|dehydration or electrolyte imbalance, including unusual dry||
0599|068|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0599|069|S|heartbeat, or confusion.||
0599|070|S|   Tell your doctor right away if you have any serious side||
0599|071|S|effects, including: signs of kidney problems (such as change in||
0599|072|S|the amount of urine), fainting, decrease in vision, eye pain.||
0599|073|S|   This drug may rarely cause serious (possibly fatal) liver||
0599|074|S|problems. Get medical help right away if you have any symptoms of||
0599|075|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0599|076|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0599|077|S|urine.||
0599|078|S|   A very serious allergic reaction to this drug is rare.||
0599|079|S|However, get medical help right away if you notice any symptoms||
0599|080|S|of a serious allergic reaction, including: rash, itching/swelling||
0599|081|S|(especially of the face/tongue/throat/neck), severe dizziness,||
0599|082|S|trouble breathing.||
0599|083|S|   This is not a complete list of possible side effects. If you||
0599|084|S|notice other effects not listed above, contact your doctor or||
0599|085|S|pharmacist.||
0599|086|S|   In the US -||
0599|087|S|   Call your doctor for medical advice about side effects. You||
0599|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0599|089|S|www.fda.gov/medwatch.||
0599|090|S|   In Canada - Call your doctor for medical advice about side||
0599|091|S|effects. You may report side effects to Health Canada at||
0599|092|S|1-866-234-2345.||
0599|093|B|||
0599|094|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0599|095|P|pharmacist if you are allergic to either perindopril or||
0599|096|P|indapamide; or to other ACE inhibitors (such as captopril,||
0599|097|P|lisinopril); or to thiazides (such as hydrochlorothiazide); or if||
0599|098|P|you have any other allergies. This product may contain inactive||
0599|099|P|ingredients, which can cause allergic reactions or other||
0599|100|P|problems. Talk to your pharmacist for more details.||
0599|101|P|   Before using this medication, tell your doctor or pharmacist||
0599|102|P|your medical history, especially of: history of an allergic||
0599|103|P|reaction which included swelling of the face/lips/tongue/throat||
0599|104|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
0599|105|P|dialysis), gout, kidney problems, liver disease, dehydration,||
0599|106|P|untreated mineral imbalances (such as high or low potassium),||
0599|107|P|lupus.||
0599|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0599|109|P|can make you more dizzy. Do not drive, use machinery, or do||
0599|110|P|anything that needs alertness until you can do it safely. Limit||
0599|111|P|alcoholic beverages. Talk to your doctor if you are using||
0599|112|P|marijuana (cannabis).||
0599|113|P|   Before having surgery, tell your doctor or dentist about all||
0599|114|P|the products you use (including prescription drugs,||
0599|115|P|nonprescription drugs, and herbal products).||
0599|116|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0599|117|P|and cause you to feel lightheaded. Tell your doctor if you have||
0599|118|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0599|119|P|of fluids unless your doctor tells you not to.||
0599|120|P|   This medication may make you more sensitive to the sun. Limit||
0599|121|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0599|122|P|sunscreen and wear protective clothing when outdoors. Tell your||
0599|123|P|doctor right away if you get sunburned or have skin||
0599|124|P|blisters/redness.||
0599|125|P|   This product may affect your potassium levels. Before using||
0599|126|P|potassium supplements or salt substitutes containing potassium,||
0599|127|P|consult your doctor or pharmacist.||
0599|128|P|   If you have diabetes, this product may increase your blood||
0599|129|P|sugar. Check your blood sugar regularly as directed and share the||
0599|130|P|results with your doctor. Tell your doctor right away if you have||
0599|131|P|symptoms of high blood sugar such as increased thirst/urination.||
0599|132|P|Your doctor may need to adjust your diabetes medication, exercise||
0599|133|P|program, or diet.||
0599|134|P|   Older adults may be more sensitive to the side effects of this||
0599|135|P|drug, especially change in the amount of urine (kidney problems)||
0599|136|P|and dizziness.||
0599|137|P|   Tell your doctor if you are pregnant or plan to become||
0599|138|P|pregnant. You should not become pregnant while using this||
0599|139|P|product. Perindopril may harm an unborn baby. If you become||
0599|140|P|pregnant, talk to your doctor right away about the risks and||
0599|141|P|benefits of this medication. (See also Warning section.)||
0599|142|P|   It is unknown if this medication passes into breast milk.||
0599|143|P|Consult your doctor before breastfeeding.||
0599|144|B|||
0599|145|I|DRUG INTERACTIONS:  See also How to Use and Precautions section.||
0599|146|I|   Drug interactions may change how your medications work or||
0599|147|I|increase your risk for serious side effects. This document does||
0599|148|I|not contain all possible drug interactions. Keep a list of all||
0599|149|I|the products you use (including prescription/nonprescription||
0599|150|I|drugs and herbal products) and share it with your doctor and||
0599|151|I|pharmacist. Do not start, stop, or change the dosage of any||
0599|152|I|medicines without your doctor's approval.||
0599|153|I|   Some products that may interact with this drug are: aliskiren,||
0599|154|I|dofetilide, gold injections, lithium, sacubitril, certain drugs||
0599|155|I|that weaken the immune system/increase the risk of infection||
0599|156|I|(such as everolimus, sirolimus), drugs that may increase the||
0599|157|I|level of potassium in the blood (such as ARBs including||
0599|158|I|losartan/valsartan, birth control pills containing drospirenone).||
0599|159|I|   Some products have ingredients that could raise your blood||
0599|160|I|pressure. Tell your pharmacist what products you are using, and||
0599|161|I|ask how to use them safely (especially cough-and-cold products,||
0599|162|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0599|163|I|   A very serious reaction may occur if you are getting||
0599|164|I|injections for bee/wasp sting allergy (desensitization) and are||
0599|165|I|also taking perindopril/indapamide. Make sure all your doctors||
0599|166|I|know which medicines you are using.||
0599|167|I|   This product may interfere with certain lab tests (such as||
0599|168|I|parathyroid function), possibly causing false test results. Make||
0599|169|I|sure lab personnel and all your doctors know you use this||
0599|170|I|product.||
0599|171|B|||
0599|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0599|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0599|174|O|poison control center right away. US residents can call||
0599|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0599|176|O|Symptoms of overdose may include: confusion, severe dizziness,||
0599|177|O|change in the amount of urine.||
0599|178|B|||
0599|179|N|NOTES:  Do not share this medication with others.||
0599|180|N|   Lifestyle changes that may help this medication work better||
0599|181|N|include exercising, stopping smoking, and eating a||
0599|182|N|low-cholesterol/low-fat diet. Consult your doctor for more||
0599|183|N|details.||
0599|184|N|   Lab and/or medical tests (such as complete blood count, sodium||
0599|185|N|and potassium levels, kidney/liver function) should be done while||
0599|186|N|you are taking this medication. Keep all medical and lab||
0599|187|N|appointments. Consult your doctor for more details.||
0599|188|N|   Check your blood pressure and pulse (heart rate) regularly||
0599|189|N|while taking this medication. Learn how to check your own blood||
0599|190|N|pressure and pulse at home, and share the results with your||
0599|191|N|doctor.||
0599|192|B|||
0599|193|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0599|194|D|remember. If it is near the time of the next dose, skip the||
0599|195|D|missed dose. Take your next dose at the regular time. Do not||
0599|196|D|double the dose to catch up.||
0599|197|B|||
0599|198|R|STORAGE:  Store at room temperature away from light and moisture.||
0599|199|R|Do not store in the bathroom. Keep all medications away from||
0599|200|R|children and pets.||
0599|201|R|   Do not flush medications down the toilet or pour them into a||
0599|202|R|drain unless instructed to do so. Properly discard this product||
0599|203|R|when it is expired or no longer needed. Consult your pharmacist||
0599|204|R|or local waste disposal company.||
0599|205|B|||
0599|206|A|Information last revised May 2024.||
0599|207|A|Copyright(c) 2025 First Databank, Inc.||
0599|208|B|||
0601|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0601|002|Z|does NOT have all possible information about this product. This||
0601|003|Z|information does not assure that this product is safe, effective,||
0601|004|Z|or appropriate for you. This information is not individual||
0601|005|Z|medical advice and does not substitute for the advice of your||
0601|006|Z|health care professional. Always ask your health care||
0601|007|Z|professional for complete information about this product and your||
0601|008|Z|specific health needs.||
0601|009|B|||
0601|010|T|PREDNISOLONE - ORAL||
0601|011|F|(pred-NISS-oh-lone)||
0601|012|B|||
0601|013|C|COMMON BRAND NAME(S): Delta-Cortef, Millipred DP||
0601|014|B|||
0601|015|U|USES:  Prednisolone is a man-made form of a natural substance||
0601|016|U|(corticosteroid hormone) made by the adrenal gland. It is used to||
0601|017|U|treat conditions such as arthritis, blood problems, immune system||
0601|018|U|disorders, skin and eye conditions, breathing problems, cancer,||
0601|019|U|and severe allergies. It decreases your immune system's response||
0601|020|U|to various diseases to reduce symptoms such as pain, swelling and||
0601|021|U|allergic-type reactions.||
0601|022|B|||
0601|023|H|HOW TO USE:  Take this medication by mouth, with food or milk to||
0601|024|H|prevent stomach upset, exactly as directed by your doctor. Take||
0601|025|H|this medication with a full glass of water (8 ounces/240||
0601|026|H|milliliters) unless your doctor directs you otherwise.||
0601|027|H|   Follow the dosing schedule carefully. The dosage and length of||
0601|028|H|treatment are based on your medical condition and response to||
0601|029|H|treatment. Your doctor may direct you to take prednisolone 1 to 4||
0601|030|H|times a day or take a single dose every other day. It may help to||
0601|031|H|mark your calendar with a reminder. If you are using the||
0601|032|H|prednisolone dose pack, follow the dosing schedule on the||
0601|033|H|package, unless directed otherwise by your doctor.||
0601|034|H|   Do not stop taking this medication without consulting your||
0601|035|H|doctor. Some conditions may become worse when this drug is||
0601|036|H|suddenly stopped. Your dose may need to be gradually decreased.||
0601|037|H|   If you suddenly stop using this medication, you may have||
0601|038|H|withdrawal symptoms (such as weakness, weight loss, nausea,||
0601|039|H|muscle pain, headache, tiredness, dizziness). To help prevent||
0601|040|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0601|041|H|more likely if you have used prednisolone for a long time or in||
0601|042|H|high doses. Tell your doctor or pharmacist right away if you have||
0601|043|H|withdrawal. See also Precautions section.||
0601|044|H|   Tell your doctor if your condition lasts or gets worse.||
0601|045|B|||
0601|046|S|SIDE EFFECTS:  Nausea, heartburn, headache, dizziness, menstrual||
0601|047|S|period changes, trouble sleeping, increased sweating, or acne may||
0601|048|S|occur. If any of these effects last or get worse, tell your||
0601|049|S|doctor or pharmacist promptly.||
0601|050|S|   Remember that this medication has been prescribed because your||
0601|051|S|doctor has judged that the benefit to you is greater than the||
0601|052|S|risk of side effects. Many people using this medication do not||
0601|053|S|have serious side effects.||
0601|054|S|   Because this drug works by weakening the immune system, it may||
0601|055|S|lower your ability to fight infections. This may make you more||
0601|056|S|likely to get a serious (rarely fatal) infection or make any||
0601|057|S|infection you have worse. Tell your doctor right away if you have||
0601|058|S|any signs of infection (such as sore throat that doesn't go away,||
0601|059|S|fever, chills). Use of this medication for prolonged or repeated||
0601|060|S|periods may result in oral thrush or a yeast infection. Contact||
0601|061|S|your doctor if you notice white patches in your mouth or a change||
0601|062|S|in vaginal discharge.||
0601|063|S|   This medication may rarely make your blood sugar rise, which||
0601|064|S|can cause or worsen diabetes. Tell your doctor right away if you||
0601|065|S|have symptoms of high blood sugar such as increased||
0601|066|S|thirst/urination. If you already have diabetes, check your blood||
0601|067|S|sugar regularly as directed and share the results with your||
0601|068|S|doctor. Your doctor may need to adjust your diabetes medication,||
0601|069|S|exercise program, or diet.||
0601|070|S|   Tell your doctor right away if you have any serious side||
0601|071|S|effects, including: unusual tiredness, swelling ankles/feet,||
0601|072|S|unusual weight gain, vision problems, easy bruising/bleeding,||
0601|073|S|puffy face, unusual hair growth, mental/mood changes (such as||
0601|074|S|depression, mood swings, agitation), muscle weakness/pain,||
0601|075|S|thinning skin, slow wound healing, bone pain, symptoms of||
0601|076|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
0601|077|S|black/tarry stools, vomit that looks like coffee grounds),||
0601|078|S|red/purple spots on the skin.||
0601|079|S|   Get medical help right away if you have any very serious side||
0601|080|S|effects, including: chest pain, seizures.||
0601|081|S|   A very serious allergic reaction to this drug is rare.||
0601|082|S|However, get medical help right away if you notice any symptoms||
0601|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0601|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0601|085|S|breathing.||
0601|086|S|   This is not a complete list of possible side effects. If you||
0601|087|S|notice other effects not listed above, contact your doctor or||
0601|088|S|pharmacist.||
0601|089|S|   In the US -||
0601|090|S|   Call your doctor for medical advice about side effects. You||
0601|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0601|092|S|www.fda.gov/medwatch.||
0601|093|S|   In Canada - Call your doctor for medical advice about side||
0601|094|S|effects. You may report side effects to Health Canada at||
0601|095|S|1-866-234-2345.||
0601|096|B|||
0601|097|P|PRECAUTIONS:  Before taking prednisolone, tell your doctor or||
0601|098|P|pharmacist if you are allergic to it; or to prednisone; or if you||
0601|099|P|have any other allergies. This product may contain inactive||
0601|100|P|ingredients, which can cause allergic reactions or other||
0601|101|P|problems. Talk to your pharmacist for more details.||
0601|102|P|   Before using this medication, tell your doctor or pharmacist||
0601|103|P|your medical history, especially of: eye disease (such as||
0601|104|P|cataracts, glaucoma), heart problems (such as heart failure,||
0601|105|P|recent heart attack), high blood pressure, liver disease (such as||
0601|106|P|hepatitis B), kidney disease, thyroid problems, diabetes,||
0601|107|P|stomach/intestinal problems (such as diverticulitis, ulcer),||
0601|108|P|brittle bones (osteoporosis), current/past infections (such as||
0601|109|P|tuberculosis, positive tuberculosis test, herpes, fungal),||
0601|110|P|bleeding problems, blood clots, mental/mood conditions (such as||
0601|111|P|psychosis, anxiety, depression), low salts in the blood (such as||
0601|112|P|low potassium or calcium), seizures, a certain adrenal gland||
0601|113|P|tumor (pheochromocytoma).||
0601|114|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0601|115|P|can make you more dizzy. Do not drive, use machinery, or do||
0601|116|P|anything that needs alertness until you can do it safely. Limit||
0601|117|P|alcoholic beverages. Talk to your doctor if you are using||
0601|118|P|marijuana (cannabis).||
0601|119|P|   This medication may cause stomach bleeding. Daily use of||
0601|120|P|alcohol while using this medication may increase your risk for||
0601|121|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
0601|122|P|or pharmacist for more information.||
0601|123|P|   Before having surgery, tell your doctor or dentist about all||
0601|124|P|the products you use (including prescription drugs,||
0601|125|P|nonprescription drugs, and herbal products).||
0601|126|P|   Using corticosteroid medications for a long time can make it||
0601|127|P|more difficult for your body to respond to physical stress.||
0601|128|P|Before having surgery or emergency treatment, or if you get a||
0601|129|P|serious illness/injury, tell your doctor or dentist that you are||
0601|130|P|using this medication or have used this medication within the||
0601|131|P|past 12 months. Tell your doctor right away if you develop||
0601|132|P|unusual/extreme tiredness or weight loss. If you will be using||
0601|133|P|this medication for a long time, carry a warning card or medical||
0601|134|P|ID bracelet that identifies your use of this medication.||
0601|135|P|   This medication may mask signs of infection. It can make you||
0601|136|P|more likely to get infections or may make current infections||
0601|137|P|worse. Stay away from anyone who has an infection that may easily||
0601|138|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0601|139|P|doctor if you have been exposed to an infection or for more||
0601|140|P|details.||
0601|141|P|   Tell your health care professional that you are using||
0601|142|P|prednisolone before having any immunizations/vaccinations. Avoid||
0601|143|P|contact with people who have recently received live vaccines||
0601|144|P|(such as flu vaccine inhaled through the nose).||
0601|145|P|   This medication may slow down a child's growth if used for a||
0601|146|P|long time. Consult the doctor or pharmacist for more details. See||
0601|147|P|the doctor regularly so your child's height and growth can be||
0601|148|P|checked.||
0601|149|P|   Older adults may be more sensitive to the effects of this||
0601|150|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
0601|151|P|mental/mood changes (such as confusion).||
0601|152|P|   During pregnancy, prednisolone should be used only when||
0601|153|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
0601|154|P|risks and benefits with your doctor. Infants born to mothers who||
0601|155|P|have been using this medication for an extended period of time||
0601|156|P|may have hormone problems. Tell your doctor right away if you||
0601|157|P|notice symptoms such as nausea/vomiting that doesn't stop, severe||
0601|158|P|diarrhea, or weakness in your newborn.||
0601|159|P|   This medication passes into breast milk. However, this drug is||
0601|160|P|unlikely to harm a nursing infant. Consult your doctor before||
0601|161|P|breastfeeding.||
0601|162|B|||
0601|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0601|164|I|medications work or increase your risk for serious side effects.||
0601|165|I|This document does not contain all possible drug interactions.||
0601|166|I|Keep a list of all the products you use (including||
0601|167|I|prescription/nonprescription drugs and herbal products) and share||
0601|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
0601|169|I|the dosage of any medicines without your doctor's approval.||
0601|170|I|   Some products that may interact with this drug include:||
0601|171|I|aldesleukin, desmopressin, other drugs that weaken the immune||
0601|172|I|system (such as azathioprine, cyclosporine, cancer chemotherapy),||
0601|173|I|mifepristone, drugs that can cause bleeding/bruising (including||
0601|174|I|antiplatelet drugs such as clopidogrel, "blood thinners" such as||
0601|175|I|dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen).||
0601|176|I|   Other medications can affect the removal of prednisolone from||
0601|177|I|your body, which may affect how prednisolone works. Examples||
0601|178|I|include estrogens, azole antifungals (such as itraconazole), St.||
0601|179|I|John's wort, drugs used to treat seizures (such as phenytoin),||
0601|180|I|among others.||
0601|181|I|   If your doctor has told you to take low-dose aspirin to||
0601|182|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0601|183|I|you should keep taking the aspirin unless your doctor tells you||
0601|184|I|not to. Ask your doctor or pharmacist for more details.||
0601|185|I|   This medication may interfere with certain lab tests (such as||
0601|186|I|skin tests), possibly causing false test results. Make sure lab||
0601|187|I|personnel and all your doctors know you use this drug.||
0601|188|B|||
0601|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0601|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0601|191|O|poison control center right away. US residents can call||
0601|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0601|193|B|||
0601|194|N|NOTES:  Do not share this medication with others.||
0601|195|N|   If this medication is used for a long time, lab and/or medical||
0601|196|N|tests (such as blood sugar/mineral levels, blood counts, blood||
0601|197|N|pressure, bone density tests, eye exams, height/weight||
0601|198|N|measurements, X-rays) should be done while you are taking this||
0601|199|N|medication. Keep all medical and lab appointments. Consult your||
0601|200|N|doctor for more details.||
0601|201|N|   This medication may cause bone loss (osteoporosis) when used||
0601|202|N|for a long time. Lifestyle changes that may help reduce the risk||
0601|203|N|of bone problems include doing weight-bearing exercise, stopping||
0601|204|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
0601|205|N|D. Talk to your doctor for more details.||
0601|206|B|||
0601|207|D|MISSED DOSE:  If you are taking this medication once daily and||
0601|208|D|miss a dose, take it as soon as you remember. If it is near the||
0601|209|D|time of the next dose, skip the missed dose. Take your next dose||
0601|210|D|at the regular time. If you are taking this medication every||
0601|211|D|other day, ask your doctor or pharmacist what you should do if||
0601|212|D|you miss a dose.||
0601|213|B|||
0601|214|R|STORAGE:  Store at room temperature away from light and moisture.||
0601|215|R|Do not store in the bathroom. Keep all medications away from||
0601|216|R|children and pets.||
0601|217|R|   Do not flush medications down the toilet or pour them into a||
0601|218|R|drain unless instructed to do so. Properly discard this product||
0601|219|R|when it is expired or no longer needed. Consult your pharmacist||
0601|220|R|or local waste disposal company.||
0601|221|B|||
0601|222|M|MEDICAL ALERT:  Your condition can cause complications in a||
0601|223|M|medical emergency. For information about enrolling in MedicAlert,||
0601|224|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0601|225|B|||
0601|226|A|Information last revised September 2025.||
0601|227|A|Copyright(c) 2025 First Databank, Inc.||
0601|228|B|||
0602|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0602|002|Z|does NOT have all possible information about this product. This||
0602|003|Z|information does not assure that this product is safe, effective,||
0602|004|Z|or appropriate for you. This information is not individual||
0602|005|Z|medical advice and does not substitute for the advice of your||
0602|006|Z|health care professional. Always ask your health care||
0602|007|Z|professional for complete information about this product and your||
0602|008|Z|specific health needs.||
0602|009|B|||
0602|010|T|BISOPROLOL - ORAL||
0602|011|F|(BIS-oh-PROE-lol)||
0602|012|B|||
0602|013|C|COMMON BRAND NAME(S): Zebeta||
0602|014|B|||
0602|015|W|WARNING:  Do not stop taking this medication without consulting||
0602|016|W|your doctor. Some conditions may become worse when you suddenly||
0602|017|W|stop this drug. Some people who have suddenly stopped taking||
0602|018|W|similar drugs have had chest pain, heart attack, and irregular||
0602|019|W|heartbeat. If your doctor decides you should no longer use this||
0602|020|W|drug, your doctor may direct you to gradually decrease your dose||
0602|021|W|over 1 to 2 weeks.||
0602|022|W|   When gradually stopping this medication, it is recommended||
0602|023|W|that you temporarily limit physical activity to decrease strain||
0602|024|W|on the heart. Get medical help right away if you develop chest||
0602|025|W|pain/tightness/pressure, chest pain spreading to the||
0602|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
0602|027|W|fast/irregular heartbeat.||
0602|028|B|||
0602|029|U|USES:  Bisoprolol is used with or without other medications to||
0602|030|U|treat high blood pressure (hypertension). Lowering high blood||
0602|031|U|pressure helps prevent strokes, heart attacks, and kidney||
0602|032|U|problems.||
0602|033|U|   This medication belongs to a class of drugs known as beta||
0602|034|U|blockers. It works by blocking the action of certain natural||
0602|035|U|chemicals in your body such as epinephrine on the heart and blood||
0602|036|U|vessels. This effect lowers the heart rate, blood pressure, and||
0602|037|U|strain on the heart.||
0602|038|B|||
0602|039|V|OTHER USES:  This section contains uses of this drug that are not||
0602|040|V|listed in the approved professional labeling for the drug but||
0602|041|V|that may be prescribed by your health care professional. Use this||
0602|042|V|drug for a condition that is listed in this section only if it||
0602|043|V|has been so prescribed by your health care professional.||
0602|044|V|   This drug may also be used for irregular heartbeat or mild to||
0602|045|V|moderate heart failure. It may also be used after a heart attack||
0602|046|V|to reduce the risk of another heart attack.||
0602|047|B|||
0602|048|H|HOW TO USE:  See also Warning section.||
0602|049|H|   Take this medication by mouth with or without food as directed||
0602|050|H|by your doctor, usually once a day. The dosage is based on your||
0602|051|H|medical condition and response to treatment.||
0602|052|H|   Use this medication regularly to get the most benefit from it.||
0602|053|H|To help you remember, take it at the same time each day.||
0602|054|H|   For the treatment of high blood pressure, it may take several||
0602|055|H|weeks before you get the full benefit of this drug. Keep taking||
0602|056|H|this medication even if you feel well. Most people with high||
0602|057|H|blood pressure do not feel sick.||
0602|058|H|   Tell your doctor if your condition does not get better or if||
0602|059|H|it gets worse (your blood pressure readings remain high or||
0602|060|H|increase).||
0602|061|B|||
0602|062|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
0602|063|S|   Tiredness, slow heartbeat, diarrhea, and dizziness may occur.||
0602|064|S|If any of these effects last or get worse, tell your doctor or||
0602|065|S|pharmacist promptly.||
0602|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
0602|067|S|slowly when rising from a sitting or lying position.||
0602|068|S|   This drug may reduce blood flow to your hands and feet,||
0602|069|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0602|070|S|warmly and avoid tobacco use.||
0602|071|S|   Remember that this medication has been prescribed because your||
0602|072|S|doctor has judged that the benefit to you is greater than the||
0602|073|S|risk of side effects. Many people using this medication do not||
0602|074|S|have serious side effects.||
0602|075|S|   Tell your doctor right away if you have any serious side||
0602|076|S|effects, including: very slow heartbeat, fainting, blue||
0602|077|S|fingers/toes, mental/mood changes (such as confusion, mood||
0602|078|S|swings, depression).||
0602|079|S|   Although this medication may be used to treat heart failure,||
0602|080|S|some people may rarely develop new or worsening symptoms of heart||
0602|081|S|failure. Tell your doctor right away if you experience any of||
0602|082|S|these serious side effects: shortness of breath, swelling||
0602|083|S|ankles/feet, unusual tiredness, unusual/sudden weight gain.||
0602|084|S|   A very serious allergic reaction to this drug is rare.||
0602|085|S|However, get medical help right away if you notice any symptoms||
0602|086|S|of a serious allergic reaction, including: rash, itching/swelling||
0602|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0602|088|S|breathing.||
0602|089|S|   This is not a complete list of possible side effects. If you||
0602|090|S|notice other effects not listed above, contact your doctor or||
0602|091|S|pharmacist.||
0602|092|S|   In the US -||
0602|093|S|   Call your doctor for medical advice about side effects. You||
0602|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0602|095|S|www.fda.gov/medwatch.||
0602|096|S|   In Canada - Call your doctor for medical advice about side||
0602|097|S|effects. You may report side effects to Health Canada at||
0602|098|S|1-866-234-2345.||
0602|099|B|||
0602|100|P|PRECAUTIONS:  Before taking bisoprolol, tell your doctor or||
0602|101|P|pharmacist if you are allergic to it; or if you have any other||
0602|102|P|allergies. This product may contain inactive ingredients, which||
0602|103|P|can cause allergic reactions or other problems. Talk to your||
0602|104|P|pharmacist for more details.||
0602|105|P|   Before using this medication, tell your doctor or pharmacist||
0602|106|P|your medical history, especially of: certain types of heart||
0602|107|P|rhythm problems (such as a slow heartbeat, second- or||
0602|108|P|third-degree atrioventricular block), breathing problems (such as||
0602|109|P|asthma, chronic bronchitis, emphysema), kidney disease, liver||
0602|110|P|disease, overactive thyroid disease (hyperthyroidism), serious||
0602|111|P|allergic reactions including those needing treatment with||
0602|112|P|epinephrine, blood circulation problems (such as Raynaud's||
0602|113|P|disease, peripheral vascular disease), mental/mood disorders||
0602|114|P|(such as depression), a certain muscle disease (myasthenia||
0602|115|P|gravis).||
0602|116|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0602|117|P|can make you more dizzy. Do not drive, use machinery, or do||
0602|118|P|anything that needs alertness until you can do it safely. Limit||
0602|119|P|alcoholic beverages. Talk to your doctor if you are using||
0602|120|P|marijuana (cannabis).||
0602|121|P|   Before having surgery, tell your doctor or dentist about all||
0602|122|P|the products you use (including prescription drugs,||
0602|123|P|nonprescription drugs, and herbal products).||
0602|124|P|   This product may prevent the fast/pounding heartbeat you would||
0602|125|P|usually feel when your blood sugar level falls too low||
0602|126|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0602|127|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0602|128|P|blood sugar level, such as dizziness and sweating, are not||
0602|129|P|affected by this drug.||
0602|130|P|   If you have diabetes, this product may make it harder to||
0602|131|P|control your blood sugar levels. Check your blood sugar levels||
0602|132|P|regularly as directed by your doctor. Tell your doctor right away||
0602|133|P|if you have symptoms of high blood sugar such as increased||
0602|134|P|thirst/urination. Your doctor may need to adjust your diabetes||
0602|135|P|medication, exercise program, or diet.||
0602|136|P|   Children may be at greater risk for low blood sugar||
0602|137|P|(hypoglycemia) while using this drug, especially if they are||
0602|138|P|vomiting or not eating regularly. To help prevent low blood||
0602|139|P|sugar, make sure children eat regularly. If your child cannot eat||
0602|140|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
0602|141|P|as sweating, shaking), tell the doctor right away.||
0602|142|P|   During pregnancy, this medication should be used only when||
0602|143|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0602|144|P|benefits with your doctor.||
0602|145|P|   It is unknown if this medication passes into breast milk.||
0602|146|P|Consult your doctor before breastfeeding.||
0602|147|B|||
0602|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0602|149|I|medications work or increase your risk for serious side effects.||
0602|150|I|This document does not contain all possible drug interactions.||
0602|151|I|Keep a list of all the products you use (including||
0602|152|I|prescription/nonprescription drugs and herbal products) and share||
0602|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
0602|154|I|the dosage of any medicines without your doctor's approval.||
0602|155|I|   A product that may interact with this drug is: fingolimod.||
0602|156|I|   Some products have ingredients that could raise your heart||
0602|157|I|rate or blood pressure. Tell your pharmacist what products you||
0602|158|I|are using, and ask how to use them safely (especially||
0602|159|I|cough-and-cold products, diet aids, or NSAIDs such as||
0602|160|I|ibuprofen/naproxen).||
0602|161|B|||
0602|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0602|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0602|164|O|poison control center right away. US residents can call||
0602|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0602|166|O|Symptoms of overdose may include: very slow heartbeat, severe||
0602|167|O|dizziness, severe weakness, fainting, trouble breathing.||
0602|168|B|||
0602|169|N|NOTES:  Do not share this medication with others.||
0602|170|N|   Talk with your doctor about making changes to your lifestyle||
0602|171|N|that may help this medication work better (such as stress||
0602|172|N|reduction programs, exercise, and dietary changes).||
0602|173|N|   Have your blood pressure and pulse (heart rate) checked||
0602|174|N|regularly while taking this medication. Learn how to check your||
0602|175|N|own blood pressure and pulse at home, and share the results with||
0602|176|N|your doctor.||
0602|177|N|   Lab and/or medical tests should be done while you are taking||
0602|178|N|this medication. Keep all medical and lab appointments. Consult||
0602|179|N|your doctor for more details.||
0602|180|B|||
0602|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0602|182|D|remember. If it is near the time of the next dose, skip the||
0602|183|D|missed dose. Take your next dose at the regular time. Do not||
0602|184|D|double the dose to catch up.||
0602|185|B|||
0602|186|R|STORAGE:  Store at room temperature away from light and moisture.||
0602|187|R|Do not store in the bathroom. Keep all medications away from||
0602|188|R|children and pets.||
0602|189|R|   Do not flush medications down the toilet or pour them into a||
0602|190|R|drain unless instructed to do so. Properly discard this product||
0602|191|R|when it is expired or no longer needed. Consult your pharmacist||
0602|192|R|or local waste disposal company.||
0602|193|B|||
0602|194|A|Information last revised May 2024.||
0602|195|A|Copyright(c) 2025 First Databank, Inc.||
0602|196|B|||
0604|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0604|002|Z|does NOT have all possible information about this product. This||
0604|003|Z|information does not assure that this product is safe, effective,||
0604|004|Z|or appropriate for you. This information is not individual||
0604|005|Z|medical advice and does not substitute for the advice of your||
0604|006|Z|health care professional. Always ask your health care||
0604|007|Z|professional for complete information about this product and your||
0604|008|Z|specific health needs.||
0604|009|B|||
0604|010|T|MORPHINE EXTENDED-RELEASE TABLET - ORAL||
0604|011|F|(MOR-feen SUL-fate)||
0604|012|B|||
0604|013|C|COMMON BRAND NAME(S): MS Contin||
0604|014|B|||
0604|015|W|WARNING:  Morphine has a risk for abuse and addiction, which can||
0604|016|W|lead to overdose and death. Morphine may also cause severe,||
0604|017|W|possibly fatal, breathing problems. To lower your risk, your||
0604|018|W|doctor should have you take the smallest dose of morphine that||
0604|019|W|works, and take it for the shortest possible time. See also How||
0604|020|W|to Use section for more information about addiction.||
0604|021|W|   Ask your doctor or pharmacist if you should have medication||
0604|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0604|023|W|Teach your family or household members about the signs of an||
0604|024|W|opioid overdose and how to treat it.||
0604|025|W|   The risk for severe breathing problems is higher when you||
0604|026|W|start this medication and after a dose increase, or if you take||
0604|027|W|the wrong dose/strength. Taking this medication with alcohol or||
0604|028|W|other drugs that can cause drowsiness or breathing problems may||
0604|029|W|cause very serious side effects, including death. Be sure you||
0604|030|W|know how to take morphine and what other drugs you should avoid||
0604|031|W|taking with it. See also Drug Interactions section. Get medical||
0604|032|W|help right away if any of these very serious side effects occur:||
0604|033|W|slow/shallow breathing, unusual lightheadedness, severe||
0604|034|W|drowsiness/dizziness, difficulty waking up.||
0604|035|W|   Do not break, crush, chew, or dissolve this medication. Taking||
0604|036|W|broken, crushed, chewed, or dissolved forms of extended-release||
0604|037|W|morphine could cause a fatal overdose.||
0604|038|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0604|039|W|or abuse. If someone accidentally swallows this drug, get medical||
0604|040|W|help right away.||
0604|041|W|   Before using this medication, women of childbearing age should||
0604|042|W|talk with their doctor(s) about the risks and benefits. Tell your||
0604|043|W|doctor if you are pregnant or if you plan to become pregnant.||
0604|044|W|During pregnancy, this medication should be used only when||
0604|045|W|clearly needed. It may slightly increase the risk of birth||
0604|046|W|defects if used during the first two months of pregnancy. Also,||
0604|047|W|using it for a long time or in high doses near the expected||
0604|048|W|delivery date may harm the unborn baby. To lessen the risk, take||
0604|049|W|the smallest effective dose for the shortest possible time.||
0604|050|W|Babies born to mothers who use this drug for a long time may||
0604|051|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0604|052|W|doctor right away if you notice any symptoms in your newborn baby||
0604|053|W|such as crying that doesn't stop, slow/shallow breathing,||
0604|054|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0604|055|W|difficulty gaining weight.||
0604|056|B|||
0604|057|U|USES:  This medication is used to help relieve severe ongoing||
0604|058|U|pain (such as due to cancer). Morphine belongs to a class of||
0604|059|U|drugs known as opioid analgesics. It works in the brain to change||
0604|060|U|how your body feels and responds to pain.||
0604|061|U|   The higher strengths of this drug (100 milligrams or more per||
0604|062|U|tablet) should be used only if you have been regularly taking||
0604|063|U|moderate to large amounts of opioid pain medications. These||
0604|064|U|strengths may cause overdose (even death) if taken by a person||
0604|065|U|who has not been regularly taking opioids.||
0604|066|U|   Do not use the extended-release form of morphine to relieve||
0604|067|U|pain that is mild or that will go away in a few days. This||
0604|068|U|medication is not for occasional ("as needed") use.||
0604|069|B|||
0604|070|H|HOW TO USE:  See also Warning section.||
0604|071|H|   Read the Medication Guide provided by your pharmacist before||
0604|072|H|you start using morphine and each time you get a refill. If you||
0604|073|H|have any questions, ask your doctor or pharmacist.||
0604|074|H|   Take this medication on a regular schedule as directed by your||
0604|075|H|doctor, not as needed for sudden (breakthrough) pain. Take this||
0604|076|H|drug with or without food as directed by your doctor, usually||
0604|077|H|every 8 hours or 12 hours. Some brands should only be taken every||
0604|078|H|12 hours. If you have nausea, it may help to take this drug with||
0604|079|H|food. Ask your doctor or pharmacist about other ways to decrease||
0604|080|H|nausea (such as lying down for 1 to 2 hours with as little head||
0604|081|H|movement as possible). If nausea lasts, see your doctor.||
0604|082|H|   Swallow the tablets whole. Do not break, crush, chew, or||
0604|083|H|dissolve the tablet. Doing so can release all of the drug at||
0604|084|H|once, increasing the risk of morphine overdose.||
0604|085|H|   The dosage is based on your medical condition and response to||
0604|086|H|treatment. Do not increase your dose or use this drug more often||
0604|087|H|or for longer than prescribed, because your risk of side effects||
0604|088|H|may increase. Properly stop the medication when so directed.||
0604|089|H|   Before you start taking this medication, ask your doctor or||
0604|090|H|pharmacist if you should stop or change how you use your other||
0604|091|H|opioid medication(s). Other pain relievers (such as||
0604|092|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
0604|093|H|or pharmacist about using morphine safely with other drugs.||
0604|094|H|   Suddenly stopping this medication may cause withdrawal,||
0604|095|H|especially if you have used it for a long time or in high doses.||
0604|096|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0604|097|H|Tell your doctor or pharmacist right away if you have any||
0604|098|H|withdrawal symptoms such as restlessness, mental/mood changes||
0604|099|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0604|100|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0604|101|H|aches, or sudden changes in behavior.||
0604|102|H|   When this medication is used for a long time, it may not work||
0604|103|H|as well. Talk with your doctor if this medication stops working||
0604|104|H|well.||
0604|105|H|   Though it helps many people, this medication may sometimes||
0604|106|H|cause addiction. This risk may be higher if you have a||
0604|107|H|mental/mood disorder or a substance use disorder (such as overuse||
0604|108|H|of or addiction to drugs/alcohol). Take this medication exactly||
0604|109|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0604|110|H|pharmacist for more details.||
0604|111|H|   Tell your doctor if your pain does not get better or if it||
0604|112|H|gets worse, or if you have any new pain.||
0604|113|B|||
0604|114|S|SIDE EFFECTS:  See also Warning section.||
0604|115|S|   Nausea, vomiting, constipation, sweating, lightheadedness,||
0604|116|S|dizziness, or drowsiness may occur. Some of these side effects||
0604|117|S|may decrease after you have been using this medication for a||
0604|118|S|while. If any of these effects last or get worse, tell your||
0604|119|S|doctor or pharmacist promptly.||
0604|120|S|   To prevent constipation, eat dietary fiber, drink enough||
0604|121|S|water, and exercise. You may also need to take a laxative. Ask||
0604|122|S|your pharmacist which type of laxative is right for you.||
0604|123|S|   To reduce the risk of dizziness and lightheadedness, get up||
0604|124|S|slowly when rising from a sitting or lying position.||
0604|125|S|   An empty tablet shell may appear in your stool. This effect is||
0604|126|S|harmless because your body has already absorbed the medication.||
0604|127|S|   Remember that this medication has been prescribed because your||
0604|128|S|doctor has judged that the benefit to you is greater than the||
0604|129|S|risk of side effects. Many people using this medication do not||
0604|130|S|have serious side effects.||
0604|131|S|   Tell your doctor right away if you have any serious side||
0604|132|S|effects, including: interrupted breathing during sleep (sleep||
0604|133|S|apnea), mental/mood changes (such as agitation, confusion,||
0604|134|S|hallucinations), severe stomach/abdominal pain, difficulty||
0604|135|S|urinating, signs of your adrenal glands not working well (such as||
0604|136|S|loss of appetite, unusual tiredness, weight loss), trouble||
0604|137|S|swallowing.||
0604|138|S|   Get medical help right away if you have any very serious side||
0604|139|S|effects, including: fainting, seizure, slow/shallow breathing,||
0604|140|S|severe drowsiness/difficulty waking up.||
0604|141|S|   A very serious allergic reaction to this drug is rare.||
0604|142|S|However, get medical help right away if you notice any symptoms||
0604|143|S|of a serious allergic reaction, including: rash, itching/swelling||
0604|144|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0604|145|S|breathing.||
0604|146|S|   This is not a complete list of possible side effects. If you||
0604|147|S|notice other effects not listed above, contact your doctor or||
0604|148|S|pharmacist.||
0604|149|S|   In the US -||
0604|150|S|   Call your doctor for medical advice about side effects. You||
0604|151|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0604|152|S|www.fda.gov/medwatch.||
0604|153|S|   In Canada - Call your doctor for medical advice about side||
0604|154|S|effects. You may report side effects to Health Canada at||
0604|155|S|1-866-234-2345.||
0604|156|B|||
0604|157|P|PRECAUTIONS:  Before taking morphine, tell your doctor or||
0604|158|P|pharmacist if you are allergic to it; or to other opioid pain||
0604|159|P|medications (such as codeine); or if you have any other||
0604|160|P|allergies. This product may contain inactive ingredients, which||
0604|161|P|can cause allergic reactions or other problems. Talk to your||
0604|162|P|pharmacist for more details.||
0604|163|P|   Before using this medication, tell your doctor or pharmacist||
0604|164|P|your medical history, especially of: brain disorders (such as||
0604|165|P|head injury, tumor, seizures), breathing problems (such as||
0604|166|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0604|167|P|kidney disease, liver disease, mental/mood disorders (such as||
0604|168|P|confusion, depression), personal or family history of a substance||
0604|169|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
0604|170|P|stomach/intestinal problems (such as blockage, constipation,||
0604|171|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
0604|172|P|(such as due to enlarged prostate), disease of the pancreas||
0604|173|P|(pancreatitis), gallbladder disease.||
0604|174|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0604|175|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0604|176|P|machinery, or do anything that needs alertness until you can do||
0604|177|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0604|178|P|are using marijuana (cannabis).||
0604|179|P|   Before having surgery, tell your doctor or dentist about all||
0604|180|P|the products you use (including prescription drugs,||
0604|181|P|nonprescription drugs, and herbal products).||
0604|182|P|   Older adults may be more sensitive to the side effects of this||
0604|183|P|drug, especially confusion, dizziness, drowsiness, and||
0604|184|P|slow/shallow breathing.||
0604|185|P|   During pregnancy, this medication should be used only when||
0604|186|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0604|187|P|benefits with your doctor. (See also Warning section.)||
0604|188|P|   This drug passes into breast milk and may have undesirable||
0604|189|P|effects on a nursing infant. Tell the doctor right away if your||
0604|190|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0604|191|P|breathing. Consult your doctor before breastfeeding.||
0604|192|B|||
0604|193|I|DRUG INTERACTIONS:  See also Warning section.||
0604|194|I|   Drug interactions may change how your medications work or||
0604|195|I|increase your risk for serious side effects. This document does||
0604|196|I|not contain all possible drug interactions. Keep a list of all||
0604|197|I|the products you use (including prescription/nonprescription||
0604|198|I|drugs and herbal products) and share it with your doctor and||
0604|199|I|pharmacist. Do not start, stop, or change the dosage of any||
0604|200|I|medicines without your doctor's approval.||
0604|201|I|   Some products that may interact with this drug include:||
0604|202|I|certain pain medications (mixed opioid agonist/antagonists such||
0604|203|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0604|204|I|samidorphan.||
0604|205|I|   The risk of serious side effects (such as slow/shallow||
0604|206|I|breathing, severe drowsiness/dizziness) may be increased if this||
0604|207|I|medication is taken with other products that may also cause||
0604|208|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0604|209|I|if you are taking other products such as other opioid pain or||
0604|210|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0604|211|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0604|212|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0604|213|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0604|214|I|cetirizine, diphenhydramine).||
0604|215|I|   Check the labels on all your medicines (such as allergy or||
0604|216|I|cough-and-cold products) because they may contain ingredients||
0604|217|I|that cause drowsiness. Ask your pharmacist about using those||
0604|218|I|products safely.||
0604|219|I|   This medication may interfere with certain lab tests (such as||
0604|220|I|amylase/lipase levels), possibly causing false test results. Make||
0604|221|I|sure lab personnel and all your doctors know you use this drug.||
0604|222|B|||
0604|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0604|224|O|as passing out or trouble breathing, give them naloxone or||
0604|225|O|nalmefene if available, then call 911. If the person is awake and||
0604|226|O|has no symptoms, call a poison control center right away. US||
0604|227|O|residents can call 1-800-222-1222. Canada residents can call||
0604|228|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0604|229|O|breathing, slow heartbeat, coma.||
0604|230|B|||
0604|231|N|NOTES:  Do not share this medication with others. Sharing it is||
0604|232|N|against the law.||
0604|233|N|   This medication has been prescribed for your current condition||
0604|234|N|only. Do not use it later for another condition unless told to do||
0604|235|N|so by your doctor. A different medication may be necessary in||
0604|236|N|that case.||
0604|237|B|||
0604|238|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0604|239|D|remember. If it is near the time of the next dose, skip the||
0604|240|D|missed dose. Take your next dose at the regular time. Do not||
0604|241|D|double the dose to catch up.||
0604|242|B|||
0604|243|R|STORAGE:  Store at room temperature away from light and moisture.||
0604|244|R|Do not store in the bathroom. Keep all medications away from||
0604|245|R|children and pets. See also Warning section.||
0604|246|R|   Do not flush medications down the toilet or pour them into a||
0604|247|R|drain unless instructed to do so. Properly discard this product||
0604|248|R|when it is expired or no longer needed. For more details, read||
0604|249|R|the Medication Guide, or consult your pharmacist or local waste||
0604|250|R|disposal company.||
0604|251|B|||
0604|252|A|Information last revised August 2025.||
0604|253|A|Copyright(c) 2025 First Databank, Inc.||
0604|254|B|||
0608|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0608|002|Z|does NOT have all possible information about this product. This||
0608|003|Z|information does not assure that this product is safe, effective,||
0608|004|Z|or appropriate for you. This information is not individual||
0608|005|Z|medical advice and does not substitute for the advice of your||
0608|006|Z|health care professional. Always ask your health care||
0608|007|Z|professional for complete information about this product and your||
0608|008|Z|specific health needs.||
0608|009|B|||
0608|010|T|INSULIN GLULISINE - INJECTION||
0608|011|F|(IN-su-lin GLOO-lis-een)||
0608|012|B|||
0608|013|C|COMMON BRAND NAME(S): Apidra||
0608|014|B|||
0608|015|U|USES:  Insulin glulisine is used with a proper diet and exercise||
0608|016|U|program to control high blood sugar in people with diabetes.||
0608|017|U|Controlling high blood sugar helps prevent kidney damage,||
0608|018|U|blindness, nerve problems, loss of limbs, and sexual function||
0608|019|U|problems. Proper control of diabetes may also lessen your risk of||
0608|020|U|a heart attack or stroke.||
0608|021|U|   Insulin glulisine is a man-made product that is similar to||
0608|022|U|human insulin. It replaces the insulin that your body would||
0608|023|U|normally make. Insulin glulisine starts working faster and lasts||
0608|024|U|for a shorter time than regular insulin. It works by helping||
0608|025|U|blood sugar (glucose) get into cells so your body can use it for||
0608|026|U|energy. This medication is usually used with a medium- or||
0608|027|U|long-acting insulin product.||
0608|028|B|||
0608|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0608|030|H|from your pharmacist before you start using this medication and||
0608|031|H|each time you get a refill. Ask your health care professional how||
0608|032|H|to prepare and use this medication. If you have any questions,||
0608|033|H|ask your doctor or pharmacist.||
0608|034|H|   Inject this medication under the skin as directed by your||
0608|035|H|doctor, usually within 15 minutes before eating a meal or within||
0608|036|H|20 minutes after starting the meal. Because this insulin is||
0608|037|H|fast-acting, do not use the insulin if you are unable to eat||
0608|038|H|within 15 minutes of injection or if you have low blood sugar.||
0608|039|H|Not eating right after a dose of insulin may lead to low blood||
0608|040|H|sugar (hypoglycemia). The injection is given in the stomach area,||
0608|041|H|the thigh, or the back of the upper arm. Do not inject into a||
0608|042|H|vein or muscle because very low blood sugar may occur.||
0608|043|H|   The dosage is based on your medical condition and response to||
0608|044|H|treatment. Measure each dose very carefully because even small||
0608|045|H|changes in the amount of insulin may have a large effect on your||
0608|046|H|blood sugar.||
0608|047|H|   Before using, check this product for particles or||
0608|048|H|discoloration. If either is present, do not use the insulin.||
0608|049|H|Before injecting each dose, clean the skin you are going to||
0608|050|H|inject into (the injection site) with rubbing alcohol. Change the||
0608|051|H|injection site each time to lessen injury under the skin (for||
0608|052|H|example, pits/lumps or thickened skin). Do not inject into skin||
0608|053|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
0608|054|H|not rub the injection site after a shot. Do not inject cold||
0608|055|H|insulin because this can be painful. The insulin container you||
0608|056|H|are currently using can be kept at room temperature. Learn how to||
0608|057|H|store and discard medical supplies safely.||
0608|058|H|   Giving insulin glulisine into a vein should only be done by a||
0608|059|H|health care professional. Very low blood sugar may result.||
0608|060|H|   If you are directed to inject this insulin with an infusion||
0608|061|H|pump, read the instruction manual and directions that come with||
0608|062|H|the infusion pump. If you have any questions, ask your health||
0608|063|H|care professional. Avoid exposing the pump or its tubing to||
0608|064|H|direct sunlight or other heat sources. Do not dilute insulin if||
0608|065|H|you are using an insulin pump.||
0608|066|H|   This product may be mixed only with certain other insulin||
0608|067|H|products such as NPH insulin. Always draw the insulin glulisine||
0608|068|H|into the syringe first, then follow with the longer-acting||
0608|069|H|insulin. Never inject a mixture of different insulins into a||
0608|070|H|vein. Consult your health care professional about which products||
0608|071|H|may be mixed, the proper method for mixing insulin, and the||
0608|072|H|proper way to inject mixtures of insulin. Do not mix insulins if||
0608|073|H|you are using an insulin pump.||
0608|074|H|   Do not change brands or types of insulin without directions on||
0608|075|H|how to do so from your doctor.||
0608|076|H|   Do not share your pen device with another person, even if the||
0608|077|H|needle is changed. You may give other people a serious infection,||
0608|078|H|or get a serious infection from them.||
0608|079|H|   Use this medication regularly to get the most benefit from it.||
0608|080|H|To help you remember, use it at the same times each day.||
0608|081|H|   Tell your doctor if your condition does not get better or if||
0608|082|H|it gets worse (your blood sugar is too high or too low).||
0608|083|B|||
0608|084|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
0608|085|S|irritation) or weight gain may occur. If any of these effects||
0608|086|S|last or get worse, tell your doctor or pharmacist promptly.||
0608|087|S|   Remember that this medication has been prescribed because your||
0608|088|S|doctor has judged that the benefit to you is greater than the||
0608|089|S|risk of side effects. Many people using this medication do not||
0608|090|S|have serious side effects.||
0608|091|S|   Tell your doctor right away if you have any serious side||
0608|092|S|effects, including: signs of low potassium level in the blood||
0608|093|S|(such as muscle cramps, weakness, irregular heartbeat).||
0608|094|S|   This medication can cause low blood sugar (hypoglycemia). This||
0608|095|S|may occur if you do not get enough calories from food or if you||
0608|096|S|do unusually heavy exercise. Symptoms of low blood sugar include||
0608|097|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
0608|098|S|dizziness, or tingling hands/feet. It is a good habit to carry||
0608|099|S|glucose tablets or gel to treat low blood sugar. If you don't||
0608|100|S|have these reliable forms of glucose, rapidly raise your blood||
0608|101|S|sugar by eating a quick source of sugar such as table sugar,||
0608|102|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
0608|103|S|doctor right away about the reaction and the use of this product.||
0608|104|S|To help prevent low blood sugar, eat meals on a regular schedule,||
0608|105|S|and do not skip meals. Check with your doctor or pharmacist to||
0608|106|S|find out what you should do if you miss a meal.||
0608|107|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0608|108|S|thirst/urination. If these symptoms occur, tell your doctor right||
0608|109|S|away. Your doctor may need to adjust your diabetes medication,||
0608|110|S|exercise program, or diet.||
0608|111|S|   A very serious allergic reaction to this drug is rare.||
0608|112|S|However, get medical help right away if you notice any symptoms||
0608|113|S|of a serious allergic reaction, including: rash, itching/swelling||
0608|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0608|115|S|breathing.||
0608|116|S|   This is not a complete list of possible side effects. If you||
0608|117|S|notice other effects not listed above, contact your doctor or||
0608|118|S|pharmacist.||
0608|119|S|   In the US -||
0608|120|S|   Call your doctor for medical advice about side effects. You||
0608|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0608|122|S|www.fda.gov/medwatch.||
0608|123|S|   In Canada - Call your doctor for medical advice about side||
0608|124|S|effects. You may report side effects to Health Canada at||
0608|125|S|1-866-234-2345.||
0608|126|B|||
0608|127|P|PRECAUTIONS:  Before using insulin glulisine, tell your doctor or||
0608|128|P|pharmacist if you are allergic to it; or to other insulins; or if||
0608|129|P|you have any other allergies. This product may contain inactive||
0608|130|P|ingredients, which can cause allergic reactions or other||
0608|131|P|problems. Talk to your pharmacist for more details.||
0608|132|P|   Do not use this medication when you have low blood sugar||
0608|133|P|(hypoglycemia).||
0608|134|P|   Before using this medication, tell your doctor or pharmacist||
0608|135|P|your medical history, especially of: kidney disease, liver||
0608|136|P|disease, thyroid problems.||
0608|137|P|   You may experience blurred vision, dizziness, or drowsiness||
0608|138|P|due to extremely low or high blood sugar. Do not drive, use||
0608|139|P|machinery, or do anything that needs alertness or clear vision||
0608|140|P|until you can do it safely.||
0608|141|P|   Limit alcohol while taking this medication because it can||
0608|142|P|increase your risk of developing low blood sugar.||
0608|143|P|   It may be harder to control your blood sugar when your body is||
0608|144|P|stressed (such as due to fever, infection, injury, or surgery).||
0608|145|P|Consult your doctor because this may require a change in your||
0608|146|P|treatment plan, medications, or blood sugar testing.||
0608|147|P|   Before having surgery, tell your doctor or dentist about all||
0608|148|P|the products you use (including prescription drugs,||
0608|149|P|nonprescription drugs, and herbal products).||
0608|150|P|   Check your blood sugar before and after exercise. You may need||
0608|151|P|a snack beforehand.||
0608|152|P|   If traveling across time zones, ask your doctor about how to||
0608|153|P|adjust your insulin schedule. Take extra insulin and supplies||
0608|154|P|with you.||
0608|155|P|   Older adults may be more sensitive to the side effects of this||
0608|156|P|drug, especially low blood sugar.||
0608|157|P|   Children may be more sensitive to the side effects of this||
0608|158|P|drug, especially low blood sugar.||
0608|159|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
0608|160|P|cause or worsen diabetes. Discuss a plan with your doctor for||
0608|161|P|managing your blood sugar while pregnant. Your doctor may change||
0608|162|P|your diabetes treatment during your pregnancy (such as diet and||
0608|163|P|medications including insulin).||
0608|164|P|   This medication passes into breast milk, but is unlikely to||
0608|165|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0608|166|P|Your insulin needs may change while breastfeeding.||
0608|167|B|||
0608|168|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0608|169|I|medications work or increase your risk for serious side effects.||
0608|170|I|This document does not contain all possible drug interactions.||
0608|171|I|Keep a list of all the products you use (including||
0608|172|I|prescription/nonprescription drugs and herbal products) and share||
0608|173|I|it with your doctor and pharmacist. Do not start, stop, or change||
0608|174|I|the dosage of any medicines without your doctor's approval.||
0608|175|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0608|176|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0608|177|I|heartbeat you would usually feel when your blood sugar falls too||
0608|178|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0608|179|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0608|180|I|   Many drugs can affect your blood sugar levels, making it more||
0608|181|I|difficult to control your blood sugar. Before you start, stop, or||
0608|182|I|change any medication, talk with your doctor or pharmacist about||
0608|183|I|how the medication may affect your blood sugar. Check your blood||
0608|184|I|sugar regularly as directed by your doctor. Tell your doctor||
0608|185|I|about the results and of any symptoms of high or low blood sugar.||
0608|186|I|(See also Side Effects section.) Your doctor may need to adjust||
0608|187|I|your diabetes medication, exercise program, or diet.||
0608|188|B|||
0608|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0608|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0608|191|O|poison control center right away. US residents can call||
0608|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0608|193|O|Symptoms of overdose may include: signs of low blood sugar such||
0608|194|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
0608|195|B|||
0608|196|N|NOTES:  Do not share this medication, needles, or syringes with||
0608|197|N|others.||
0608|198|N|   Attend a diabetes education program to learn more about how to||
0608|199|N|manage your diabetes with medications, diet, exercise, and||
0608|200|N|regular medical exams.||
0608|201|N|   Learn the symptoms of high and low blood sugar and how to||
0608|202|N|treat low blood sugar. Check your blood sugar regularly as||
0608|203|N|directed and share the results with your doctor.||
0608|204|N|   Lab and/or medical tests (such as liver/kidney function,||
0608|205|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
0608|206|N|should be done while you are taking this medication. Keep all||
0608|207|N|medical and lab appointments.||
0608|208|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
0608|209|B|||
0608|210|D|MISSED DOSE:  It is very important to follow your insulin regimen||
0608|211|D|exactly. Ask your doctor ahead of time what you should do if you||
0608|212|D|miss a dose of insulin.||
0608|213|B|||
0608|214|R|STORAGE:  It is best to refrigerate all unopened insulin||
0608|215|R|products. Unopened insulin glulisine may also be stored at room||
0608|216|R|temperature, but it must be thrown away after 28 days. Opened||
0608|217|R|insulin glulisine vials may be stored in the refrigerator or at||
0608|218|R|room temperature. Opened insulin glulisine cartridges and||
0608|219|R|prefilled pens can only be stored at room temperature and should||
0608|220|R|not be refrigerated. Do not store the delivery device in the||
0608|221|R|refrigerator. Throw away all insulin glulisine in use after 28||
0608|222|R|days, even if there is insulin left. Also throw away all insulin||
0608|223|R|products after the expiration date on the package. Do not freeze||
0608|224|R|and do not use insulin that has been frozen.||
0608|225|R|   If using this drug in an insulin pump, do not store this drug||
0608|226|R|in the pump for more than 48 hours. Doing so may lead to||
0608|227|R|ineffective treatment and high blood sugar. Do not expose the||
0608|228|R|insulin in your pump to direct sunlight or temperatures above||
0608|229|R|98.6 degrees F (37 degrees C).||
0608|230|R|   Protect insulin from light and heat. Do not store in the||
0608|231|R|bathroom. Keep all medications away from children and pets.||
0608|232|R|   Do not flush medications down the toilet or pour them into a||
0608|233|R|drain unless instructed to do so. Properly discard this product||
0608|234|R|when it is expired or no longer needed. Consult your pharmacist||
0608|235|R|or local waste disposal company.||
0608|236|B|||
0608|237|M|MEDICAL ALERT:  Your condition can cause complications in a||
0608|238|M|medical emergency. For information about enrolling in MedicAlert,||
0608|239|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0608|240|B|||
0608|241|A|Information last revised April 2025.||
0608|242|A|Copyright(c) 2025 First Databank, Inc.||
0608|243|B|||
0609|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0609|002|Z|does NOT have all possible information about this product. This||
0609|003|Z|information does not assure that this product is safe, effective,||
0609|004|Z|or appropriate for you. This information is not individual||
0609|005|Z|medical advice and does not substitute for the advice of your||
0609|006|Z|health care professional. Always ask your health care||
0609|007|Z|professional for complete information about this product and your||
0609|008|Z|specific health needs.||
0609|009|B|||
0609|010|T|NYSTATIN POWDER - TOPICAL||
0609|011|F|(NYE-stat-in)||
0609|012|B|||
0609|013|C|COMMON BRAND NAME(S): Nystop, Pedi-dri||
0609|014|B|||
0609|015|U|USES:  Nystatin is used to treat fungal skin infections. Nystatin||
0609|016|U|is an antifungal that works by stopping the growth of fungus.||
0609|017|B|||
0609|018|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0609|019|H|thoroughly dry the area to be treated. Apply this medication to||
0609|020|H|the affected skin as directed by your doctor, usually 2 or 3||
0609|021|H|times a day. The dosage and length of treatment depends on the||
0609|022|H|type of infection being treated. Do not apply this more often||
0609|023|H|than prescribed.||
0609|024|H|   Apply enough powder to lightly coat the affected area and some||
0609|025|H|of the surrounding skin. After applying this medication, wash||
0609|026|H|your hands unless you are using this medication to treat the||
0609|027|H|hands. Do not wrap, cover or bandage the area unless directed to||
0609|028|H|do so by your doctor. If used in the diaper area on an infant, do||
0609|029|H|not use tight-fitting diapers or plastic pants.||
0609|030|H|   Do not apply this medication in the eyes, nose, mouth, or||
0609|031|H|vagina.||
0609|032|H|   Use this medication regularly in order to get the most benefit||
0609|033|H|from it. Remember to use it at the same times each day.||
0609|034|H|   Continue to use this medication until the full prescribed||
0609|035|H|amount is finished, even if symptoms disappear after a few days.||
0609|036|H|Stopping the medication too early may result in a return of the||
0609|037|H|infection.||
0609|038|H|   Tell your doctor if your condition lasts after 2 weeks of||
0609|039|H|treatment or gets worse at any time.||
0609|040|B|||
0609|041|S|SIDE EFFECTS:  Skin irritation or redness may occur. If either of||
0609|042|S|these effects last or get worse, notify your doctor or pharmacist||
0609|043|S|promptly.||
0609|044|S|   Remember that this medication has been prescribed because your||
0609|045|S|doctor has judged that the benefit to you is greater than the||
0609|046|S|risk of side effects. Many people using this medication do not||
0609|047|S|have serious side effects.||
0609|048|S|   A very serious allergic reaction to this drug is rare.||
0609|049|S|However, get medical help right away if you notice any symptoms||
0609|050|S|of a serious allergic reaction, including: rash, itching/swelling||
0609|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0609|052|S|breathing.||
0609|053|S|   This is not a complete list of possible side effects. If you||
0609|054|S|notice other effects not listed above, contact your doctor or||
0609|055|S|pharmacist.||
0609|056|S|   In the US -||
0609|057|S|   Call your doctor for medical advice about side effects. You||
0609|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0609|059|S|www.fda.gov/medwatch.||
0609|060|S|   In Canada - Call your doctor for medical advice about side||
0609|061|S|effects. You may report side effects to Health Canada at||
0609|062|S|1-866-234-2345.||
0609|063|B|||
0609|064|P|PRECAUTIONS:  Before using nystatin, tell your doctor or||
0609|065|P|pharmacist if you are allergic to it; or if you have any other||
0609|066|P|allergies. This product may contain inactive ingredients, which||
0609|067|P|can cause allergic reactions or other problems. Talk to your||
0609|068|P|pharmacist for more details.||
0609|069|P|   Before using this medication, tell your doctor or pharmacist||
0609|070|P|your medical history.||
0609|071|P|   Before having surgery, tell your doctor or dentist about all||
0609|072|P|the products you use (including prescription drugs,||
0609|073|P|nonprescription drugs, and herbal products).||
0609|074|P|   During pregnancy, this medication should be used only when||
0609|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
0609|076|P|   It is unknown if this drug passes into breast milk. Consult||
0609|077|P|your doctor before breastfeeding.||
0609|078|B|||
0609|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0609|080|I|medications work or increase your risk for serious side effects.||
0609|081|I|This document does not contain all possible drug interactions.||
0609|082|I|Keep a list of all the products you use (including||
0609|083|I|prescription/nonprescription drugs and herbal products) and share||
0609|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
0609|085|I|the dosage of any medicines without your doctor's approval.||
0609|086|B|||
0609|087|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0609|088|O|has overdosed and has serious symptoms such as passing out or||
0609|089|O|trouble breathing, call 911. Otherwise, call a poison control||
0609|090|O|center right away. US residents can call 1-800-222-1222. Canada||
0609|091|O|residents can call 1-844-764-7669. Symptoms that may occur after||
0609|092|O|swallowing include: nausea, vomiting or stomach upset.||
0609|093|B|||
0609|094|N|NOTES:  Do not share this medication with others.||
0609|095|N|   This medication has been prescribed for your current condition||
0609|096|N|only. Do not use it later for another infection unless your||
0609|097|N|doctor tells you to.||
0609|098|B|||
0609|099|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0609|100|D|If it is near the time of the next dose, skip the missed dose.||
0609|101|D|Use your next dose at the regular time. Do not double the dose to||
0609|102|D|catch up.||
0609|103|B|||
0609|104|R|STORAGE:  Store at room temperature. Keep all medications away||
0609|105|R|from children and pets.||
0609|106|R|   Do not flush medications down the toilet or pour them into a||
0609|107|R|drain unless instructed to do so. Properly discard this product||
0609|108|R|when it is expired or no longer needed. Consult your pharmacist||
0609|109|R|or local waste disposal company.||
0609|110|B|||
0609|111|A|Information last revised May 2024.||
0609|112|A|Copyright(c) 2025 First Databank, Inc.||
0609|113|B|||
0610|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0610|002|Z|does NOT have all possible information about this product. This||
0610|003|Z|information does not assure that this product is safe, effective,||
0610|004|Z|or appropriate for you. This information is not individual||
0610|005|Z|medical advice and does not substitute for the advice of your||
0610|006|Z|health care professional. Always ask your health care||
0610|007|Z|professional for complete information about this product and your||
0610|008|Z|specific health needs.||
0610|009|B|||
0610|010|T|DOXEPIN - ORAL||
0610|011|F|(dox-EH-pin)||
0610|012|B|||
0610|013|C|COMMON BRAND NAME(S): Sinequan||
0610|014|B|||
0610|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0610|016|W|of conditions, including depression and other mental/mood||
0610|017|W|disorders. These medications can help prevent suicidal||
0610|018|W|thoughts/attempts and provide other important benefits. However,||
0610|019|W|studies have shown that a small number of people (especially||
0610|020|W|people younger than 25) who take antidepressants for any||
0610|021|W|condition may experience worsening depression, other mental/mood||
0610|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0610|023|W|talk with the doctor about the risks and benefits of||
0610|024|W|antidepressant medication (especially for people younger than||
0610|025|W|25), even if treatment is not for a mental/mood condition. Tell||
0610|026|W|the doctor right away if you notice worsening depression/other||
0610|027|W|psychiatric conditions, unusual behavior changes (including||
0610|028|W|possible suicidal thoughts/attempts), or other mental/mood||
0610|029|W|changes (including new/worsening anxiety, panic attacks, trouble||
0610|030|W|sleeping, irritability, hostile/angry feelings, impulsive||
0610|031|W|actions, severe restlessness, very rapid speech). Be especially||
0610|032|W|watchful for these symptoms when a new antidepressant is started||
0610|033|W|or when the dose is changed.||
0610|034|B|||
0610|035|U|USES:  This medication is used to treat certain mental/mood||
0610|036|U|disorders (such as depression, anxiety). Doxepin belongs to a||
0610|037|U|class of drugs known as tricyclic antidepressants. It works by||
0610|038|U|helping to restore the balance of certain natural substances in||
0610|039|U|the brain.||
0610|040|B|||
0610|041|H|HOW TO USE:  Read the Medication Guide provided by your||
0610|042|H|pharmacist before you start taking doxepin and each time you get||
0610|043|H|a refill. If you have any questions, consult your doctor or||
0610|044|H|pharmacist.||
0610|045|H|   Take this medication by mouth as directed by your doctor,||
0610|046|H|usually 1 to 3 times daily. If you take it only once a day, take||
0610|047|H|it at bedtime to reduce daytime sleepiness. The dosage is based||
0610|048|H|on your medical condition and response to treatment.||
0610|049|H|   To reduce your risk of side effects (such as drowsiness, dry||
0610|050|H|mouth, dizziness), your doctor may direct you to start this||
0610|051|H|medication at a low dose and gradually increase your dose. Follow||
0610|052|H|your doctor's instructions carefully.||
0610|053|H|   Take this medication regularly in order to get the most||
0610|054|H|benefit from it. To help you remember, take it at the same||
0610|055|H|time(s) each day. Do not increase your dose or use this drug more||
0610|056|H|often or for longer than prescribed. Your condition will not||
0610|057|H|improve any faster, and your risk of side effects will increase.||
0610|058|H|   Keep taking this medication even if you feel well. Do not stop||
0610|059|H|taking this medication without consulting your doctor. Some||
0610|060|H|conditions may become worse when this drug is suddenly stopped.||
0610|061|H|Also, you may experience symptoms such as mood swings, headache,||
0610|062|H|and tiredness. To prevent these symptoms while you are stopping||
0610|063|H|treatment with this drug, your doctor may reduce your dose||
0610|064|H|gradually. Consult your doctor or pharmacist for more details.||
0610|065|H|Report any new or worsening symptoms right away.||
0610|066|H|   This medication may not work right away. You may see some||
0610|067|H|benefit within a week. However, it may take up to 3 weeks before||
0610|068|H|you feel the full effect.||
0610|069|H|   Tell your doctor if your condition lasts or gets worse (such||
0610|070|H|as your feelings of sadness get worse, or you have thoughts of||
0610|071|H|suicide).||
0610|072|B|||
0610|073|S|SIDE EFFECTS:  See also Warning section.||
0610|074|S|   Drowsiness, dizziness, dry mouth, blurred vision,||
0610|075|S|constipation, or trouble urinating may occur. If any of these||
0610|076|S|effects last or get worse, notify your doctor or pharmacist||
0610|077|S|promptly.||
0610|078|S|   To reduce the risk of dizziness and lightheadedness, get up||
0610|079|S|slowly when rising from a sitting or lying position.||
0610|080|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0610|081|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0610|082|S|substitute.||
0610|083|S|   To prevent constipation, eat dietary fiber, drink enough||
0610|084|S|water, and exercise. You may also need to take a laxative. Ask||
0610|085|S|your pharmacist which type of laxative is right for you.||
0610|086|S|   Remember that this medication has been prescribed because your||
0610|087|S|doctor has judged that the benefit to you is greater than the||
0610|088|S|risk of side effects. Many people using this medication do not||
0610|089|S|have serious side effects.||
0610|090|S|   Tell your doctor right away if you have any serious side||
0610|091|S|effects, including: heartburn that doesn't go away, mental/mood||
0610|092|S|changes (such as anxiety, confusion), shaking, severe||
0610|093|S|stomach/abdominal pain.||
0610|094|S|   Get medical help right away if you have any very serious side||
0610|095|S|effects, including: irregular heartbeat, fainting, seizures, eye||
0610|096|S|pain/swelling/redness, widened pupils, vision changes (such as||
0610|097|S|seeing rainbows around lights at night).||
0610|098|S|   This medication may increase serotonin and rarely cause a very||
0610|099|S|serious condition called serotonin syndrome/toxicity. The risk||
0610|100|S|increases if you are also taking other drugs that increase||
0610|101|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0610|102|S|take (see Drug Interactions section). Get medical help right away||
0610|103|S|if you develop some of the following symptoms: fast heartbeat,||
0610|104|S|hallucinations, loss of coordination, severe dizziness, severe||
0610|105|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0610|106|S|unusual agitation/restlessness.||
0610|107|S|   A very serious allergic reaction to this drug is rare.||
0610|108|S|However, get medical help right away if you notice any symptoms||
0610|109|S|of a serious allergic reaction, including: rash, itching/swelling||
0610|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0610|111|S|breathing.||
0610|112|S|   This is not a complete list of possible side effects. If you||
0610|113|S|notice other effects not listed above, contact your doctor or||
0610|114|S|pharmacist.||
0610|115|S|   In the US -||
0610|116|S|   Call your doctor for medical advice about side effects. You||
0610|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0610|118|S|www.fda.gov/medwatch.||
0610|119|S|   In Canada - Call your doctor for medical advice about side||
0610|120|S|effects. You may report side effects to Health Canada at||
0610|121|S|1-866-234-2345.||
0610|122|B|||
0610|123|P|PRECAUTIONS:  See also Warning section.||
0610|124|P|   Before taking doxepin, tell your doctor or pharmacist if you||
0610|125|P|are allergic to it; or to other tricyclic antidepressants (such||
0610|126|P|as nortriptyline); or if you have any other allergies. This||
0610|127|P|product may contain inactive ingredients, which can cause||
0610|128|P|allergic reactions or other problems. Talk to your pharmacist for||
0610|129|P|more details.||
0610|130|P|   Before using this medication, tell your doctor or pharmacist||
0610|131|P|your medical history, especially of: bleeding problems, breathing||
0610|132|P|problems, liver problems, recent heart attack, problems urinating||
0610|133|P|(such as due to enlarged prostate), overactive thyroid||
0610|134|P|(hyperthyroidism), personal or family history of glaucoma||
0610|135|P|(angle-closure type), personal or family history of mental/mood||
0610|136|P|conditions (such as bipolar disorder, psychosis), family history||
0610|137|P|of suicide, seizures, conditions that may increase your risk of||
0610|138|P|seizures (such as other brain disease, alcohol/sedative||
0610|139|P|withdrawal).||
0610|140|P|   Doxepin may cause a condition that affects the heart rhythm||
0610|141|P|(QT prolongation). QT prolongation can rarely cause serious||
0610|142|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0610|143|P|as severe dizziness, fainting) that need medical attention right||
0610|144|P|away.||
0610|145|P|   The risk of QT prolongation may be increased if you have||
0610|146|P|certain medical conditions or are taking other drugs that may||
0610|147|P|cause QT prolongation. Before using doxepin, tell your doctor or||
0610|148|P|pharmacist of all the drugs you take and if you have any of the||
0610|149|P|following conditions: certain heart problems (heart failure, slow||
0610|150|P|heartbeat, QT prolongation in the EKG), family history of certain||
0610|151|P|heart problems (QT prolongation in the EKG, sudden cardiac||
0610|152|P|death).||
0610|153|P|   Low levels of potassium or magnesium in the blood may also||
0610|154|P|increase your risk of QT prolongation. This risk may increase if||
0610|155|P|you use certain drugs (such as diuretics/"water pills") or if you||
0610|156|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0610|157|P|Talk to your doctor about using doxepin safely.||
0610|158|P|   This drug may make you dizzy or drowsy or blur your vision.||
0610|159|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0610|160|P|drowsy. Do not drive, use machinery, or do anything that needs||
0610|161|P|alertness or clear vision until you can do it safely. Limit||
0610|162|P|alcoholic beverages. Talk to your doctor if you are using||
0610|163|P|marijuana (cannabis).||
0610|164|P|   Before having surgery, tell your doctor or dentist about all||
0610|165|P|the products you use (including prescription drugs,||
0610|166|P|nonprescription drugs, and herbal products).||
0610|167|P|   This medication may make you more sensitive to the sun. Limit||
0610|168|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0610|169|P|sunscreen and wear protective clothing when outdoors. Tell your||
0610|170|P|doctor right away if you get sunburned or have skin||
0610|171|P|blisters/redness.||
0610|172|P|   If you have diabetes, this drug may make it harder to control||
0610|173|P|your blood sugar levels. Monitor your blood sugar levels||
0610|174|P|regularly and tell your doctor of the results. Your doctor may||
0610|175|P|need to adjust your diabetes medication, exercise program, or||
0610|176|P|diet.||
0610|177|P|   Older adults may be more sensitive to the side effects of this||
0610|178|P|drug, especially dry mouth, dizziness, drowsiness, confusion,||
0610|179|P|difficulty urinating, and QT prolongation (see above).||
0610|180|P|   During pregnancy, this medication should be used only when||
0610|181|P|clearly needed. Babies born to mothers who have used this drug||
0610|182|P|during the last 3 months of pregnancy may rarely develop||
0610|183|P|withdrawal symptoms such as feeding/breathing difficulties,||
0610|184|P|seizures, muscle stiffness, or constant crying. If you notice any||
0610|185|P|of these symptoms in your newborn, tell the doctor promptly.||
0610|186|P|   Since untreated mental/mood problems (such as depression,||
0610|187|P|anxiety) can be a serious condition, do not stop using this||
0610|188|P|medication unless directed by your doctor. If you are planning||
0610|189|P|pregnancy, become pregnant, or think you may be pregnant,||
0610|190|P|immediately discuss with your doctor the benefits and risks of||
0610|191|P|using this medication during pregnancy.||
0610|192|P|   This medication passes into breast milk and may have||
0610|193|P|undesirable effects on a nursing infant. Breastfeeding is not||
0610|194|P|recommended while using this medication. Consult your doctor||
0610|195|P|before breastfeeding.||
0610|196|B|||
0610|197|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0610|198|I|medications work or increase your risk for serious side effects.||
0610|199|I|This document does not contain all possible drug interactions.||
0610|200|I|Keep a list of all the products you use (including||
0610|201|I|prescription/nonprescription drugs and herbal products) and share||
0610|202|I|it with your doctor and pharmacist. Do not start, stop, or change||
0610|203|I|the dosage of any medicines without your doctor's approval.||
0610|204|I|   Some products that may interact with this drug include:||
0610|205|I|thyroid supplements, central-acting drugs to treat high blood||
0610|206|I|pressure (such as clonidine, guanabenz).||
0610|207|I|   Taking MAO inhibitors with this medication may cause a serious||
0610|208|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0610|209|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0610|210|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0610|211|I|selegiline, tranylcypromine) during treatment with this||
0610|212|I|medication. Most MAO inhibitors should also not be taken for two||
0610|213|I|weeks before and after treatment with this medication. Ask your||
0610|214|I|doctor when to start or stop taking this medication.||
0610|215|I|   The risk of serotonin syndrome/toxicity increases if you are||
0610|216|I|also taking other drugs that increase serotonin. Examples include||
0610|217|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
0610|218|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0610|219|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0610|220|I|serotonin syndrome/toxicity may be more likely when you start or||
0610|221|I|increase the dose of these drugs.||
0610|222|I|   Other medications can affect the removal of doxepin from your||
0610|223|I|body, thereby affecting how doxepin works. These drugs include||
0610|224|I|cimetidine, drugs to treat irregular heart rate (such as||
0610|225|I|quinidine/propafenone/flecainide), among others.||
0610|226|I|   Many drugs besides doxepin may affect the heart rhythm (QT||
0610|227|I|prolongation in the EKG), including amiodarone, dofetilide,||
0610|228|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
0610|229|I|(such as erythromycin), among others. Before using doxepin,||
0610|230|I|report all medications you are currently using to your doctor or||
0610|231|I|pharmacist.||
0610|232|I|   Tell your doctor or pharmacist if you are taking other||
0610|233|I|products that cause drowsiness such as opioid pain or cough||
0610|234|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0610|235|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0610|236|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0610|237|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0610|238|I|diphenhydramine).||
0610|239|I|   Check the labels on all your medicines (such as allergy or||
0610|240|I|cough-and-cold products) because they may contain ingredients||
0610|241|I|that cause drowsiness. Ask your pharmacist about using those||
0610|242|I|products safely.||
0610|243|B|||
0610|244|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0610|245|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0610|246|O|poison control center right away. US residents can call||
0610|247|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0610|248|O|Symptoms of overdose may include: extreme drowsiness,||
0610|249|O|hallucinations, fast/irregular heartbeat, fainting, slow/shallow||
0610|250|O|breathing, seizures.||
0610|251|B|||
0610|252|N|NOTES:  Do not share this medication with others.||
0610|253|N|   Lab and/or medical tests (such as blood counts, blood||
0610|254|N|pressure, EKG, liver tests) may be done while you are taking this||
0610|255|N|medication. Keep all medical and lab appointments. Consult your||
0610|256|N|doctor for more details.||
0610|257|B|||
0610|258|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0610|259|D|remember. If it is near the time of the next dose, skip the||
0610|260|D|missed dose. Take your next dose at the regular time. Do not||
0610|261|D|double the dose to catch up.||
0610|262|B|||
0610|263|R|STORAGE:  Store at room temperature away from light and moisture.||
0610|264|R|Do not store in the bathroom. Keep all medications away from||
0610|265|R|children and pets.||
0610|266|R|   Do not flush medications down the toilet or pour them into a||
0610|267|R|drain unless instructed to do so. Properly discard this product||
0610|268|R|when it is expired or no longer needed. Consult your pharmacist||
0610|269|R|or local waste disposal company.||
0610|270|B|||
0610|271|A|Information last revised July 2025.||
0610|272|A|Copyright(c) 2025 First Databank, Inc.||
0610|273|B|||
0611|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0611|002|Z|does NOT have all possible information about this product. This||
0611|003|Z|information does not assure that this product is safe, effective,||
0611|004|Z|or appropriate for you. This information is not individual||
0611|005|Z|medical advice and does not substitute for the advice of your||
0611|006|Z|health care professional. Always ask your health care||
0611|007|Z|professional for complete information about this product and your||
0611|008|Z|specific health needs.||
0611|009|B|||
0611|010|T|LUTROPIN ALFA - INJECTION||
0611|011|F|(loo-TROE-pin AL-fa)||
0611|012|B|||
0611|013|C|COMMON BRAND NAME(S): Luveris||
0611|014|B|||
0611|015|U|USES:  This medication is used to help women with fertility||
0611|016|U|problems get pregnant. It is generally used in combination with 2||
0611|017|U|other hormones (FSH and hCG). Lutropin alfa provides luteinizing||
0611|018|U|hormone (LH), which together with FSH helps your body get an egg||
0611|019|U|ready for ovulation to help you get pregnant.||
0611|020|U|   This medication is not recommended for women whose ovaries no||
0611|021|U|longer make eggs properly (primary ovarian failure).||
0611|022|B|||
0611|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0611|024|H|from your pharmacist before you start using lutropin alfa and||
0611|025|H|each time you get a refill. Ask your health care professional how||
0611|026|H|to prepare and use this medication. If you have any questions,||
0611|027|H|ask your doctor or pharmacist.||
0611|028|H|   Inject this medication under the skin as directed by your||
0611|029|H|doctor, usually once daily. The injection is given in the abdomen||
0611|030|H|or upper thigh. The dosage is based on your medical condition and||
0611|031|H|response to treatment. Lutropin alfa is usually given at the same||
0611|032|H|time as FSH. The dose of hCG is usually given 1 day after the||
0611|033|H|last dose of LH and FSH. Follow your doctor's instructions||
0611|034|H|carefully to make sure these medications are timed properly.||
0611|035|H|   If the medication and the solution used to mix it are||
0611|036|H|refrigerated, take them out of the refrigerator to allow them to||
0611|037|H|reach room temperature before mixing. After mixing, gently swirl||
0611|038|H|to completely dissolve the powder. Do not shake. Use the mixed||
0611|039|H|medication right away. Do not save for future use. Before using,||
0611|040|H|check this product for particles or discoloration. If either is||
0611|041|H|present, do not use the liquid. Before injecting each dose, clean||
0611|042|H|the skin you are going to inject into (the injection site) with||
0611|043|H|rubbing alcohol. Change the injection site each time to lessen||
0611|044|H|injury under the skin. To lessen bruising, do not rub the||
0611|045|H|injection site after a shot. Learn how to store and discard||
0611|046|H|medical supplies safely.||
0611|047|H|   Use this medication exactly as directed by your doctor to get||
0611|048|H|the most benefit from it. To help you remember, use it at the||
0611|049|H|same time as scheduled. Do not change the dose unless instructed||
0611|050|H|by your doctor, and do not use this drug for a longer period than||
0611|051|H|prescribed.||
0611|052|H|   Usually, daily sexual intercourse is recommended beginning on||
0611|053|H|the day before the hCG hormone is given and continuing until||
0611|054|H|clear signs of ovulation occur (such as a rise in basal body||
0611|055|H|temperature). Follow your doctor's instructions.||
0611|056|B|||
0611|057|S|SIDE EFFECTS:  Redness/pain at the injection site, headache,||
0611|058|S|tiredness, or mild nausea may occur. If any of these effects last||
0611|059|S|or get worse, tell your doctor or pharmacist promptly.||
0611|060|S|   Remember that this medication has been prescribed because your||
0611|061|S|doctor has judged that the benefit to you is greater than the||
0611|062|S|risk of side effects. Many people using this medication do not||
0611|063|S|have serious side effects.||
0611|064|S|   Tell your doctor right away if you have any serious side||
0611|065|S|effects, including: bloating, pain/swelling in the lower||
0611|066|S|abdominal (pelvic) area, unusual vaginal bleeding.||
0611|067|S|   Get medical help right away if you have any very serious side||
0611|068|S|effects, including: weakness on one side of the body, trouble||
0611|069|S|speaking, vision changes, sudden/severe headache, pain/swelling||
0611|070|S|of the calf muscles, chest pain, shortness of breath, swelling of||
0611|071|S|ankles/hands/feet.||
0611|072|S|   This medication may cause a condition known as ovarian||
0611|073|S|hyperstimulation syndrome (OHSS). This condition may occur during||
0611|074|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
0611|075|S|build up in the stomach, chest, and heart area. Get medical help||
0611|076|S|right away if you develop the following side effects: severe pain||
0611|077|S|or swelling in the lower abdominal (pelvic) area, severe||
0611|078|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
0611|079|S|urination.||
0611|080|S|   A very serious allergic reaction to this drug is rare.||
0611|081|S|However, get medical help right away if you notice any symptoms||
0611|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0611|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0611|084|S|breathing.||
0611|085|S|   This is not a complete list of possible side effects. If you||
0611|086|S|notice other effects not listed above, contact your doctor or||
0611|087|S|pharmacist.||
0611|088|S|   In the US -||
0611|089|S|   Call your doctor for medical advice about side effects. You||
0611|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0611|091|S|www.fda.gov/medwatch.||
0611|092|S|   In Canada - Call your doctor for medical advice about side||
0611|093|S|effects. You may report side effects to Health Canada at||
0611|094|S|1-866-234-2345.||
0611|095|B|||
0611|096|P|PRECAUTIONS:  Before using lutropin alfa, tell your doctor or||
0611|097|P|pharmacist if you are allergic to it; or to other products||
0611|098|P|containing luteinizing hormone (LH); or if you have any other||
0611|099|P|allergies. This product may contain inactive ingredients, which||
0611|100|P|can cause allergic reactions or other problems. Talk to your||
0611|101|P|pharmacist for more details.||
0611|102|P|   Before using this medication, tell your doctor or pharmacist||
0611|103|P|your medical history, especially of: other fertility problems||
0611|104|P|(such as primary ovarian failure), thyroid or adrenal gland||
0611|105|P|problems, cancer of the reproductive organs (such as breast,||
0611|106|P|uterus, ovary), tumor in the brain (such as pituitary tumor),||
0611|107|P|abnormal bleeding from the uterus/vagina, unexplained ovarian||
0611|108|P|cysts or enlarged ovaries, blood clots, stroke, certain heart||
0611|109|P|problems (such as heart attack), liver disease, lung problems||
0611|110|P|(such as asthma).||
0611|111|P|   Before having surgery, tell your doctor or dentist about all||
0611|112|P|the products you use (including prescription drugs,||
0611|113|P|nonprescription drugs, and herbal products).||
0611|114|P|   Multiple births may occur because of this treatment. Consult||
0611|115|P|your doctor for more details.||
0611|116|P|   Stop using this medication when you become pregnant. This||
0611|117|P|medication must not be used during pregnancy. It may harm an||
0611|118|P|unborn baby. If you think you may be pregnant, tell your doctor||
0611|119|P|right away.||
0611|120|P|   It is unknown if this drug passes into breast milk. Consult||
0611|121|P|your doctor before breastfeeding.||
0611|122|B|||
0611|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0611|124|I|medications work or increase your risk for serious side effects.||
0611|125|I|This document does not contain all possible drug interactions.||
0611|126|I|Keep a list of all the products you use (including||
0611|127|I|prescription/nonprescription drugs and herbal products) and share||
0611|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
0611|129|I|the dosage of any medicines without your doctor's approval.||
0611|130|I|   A product that may interact with this drug is: gonadorelin.||
0611|131|B|||
0611|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0611|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0611|134|O|poison control center right away. US residents can call||
0611|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0611|136|B|||
0611|137|N|NOTES:  Do not share this medication with others.||
0611|138|N|   Lab and/or medical tests (such as vaginal ultrasound, blood||
0611|139|N|hormone tests such as estradiol levels) should be done while you||
0611|140|N|are using this medication. Keep all medical and lab appointments.||
0611|141|N|Consult your doctor for more details.||
0611|142|B|||
0611|143|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
0611|144|D|right away for a new dosing schedule. Do not double the dose to||
0611|145|D|catch up.||
0611|146|B|||
0611|147|R|STORAGE:  Store in the refrigerator or at room temperature away||
0611|148|R|from light and heat. Do not freeze. Keep all medications away||
0611|149|R|from children and pets.||
0611|150|R|   Do not flush medications down the toilet or pour them into a||
0611|151|R|drain unless instructed to do so. Properly discard this product||
0611|152|R|when it is expired or no longer needed. Consult your pharmacist||
0611|153|R|or local waste disposal company.||
0611|154|B|||
0611|155|A|Information last revised September 2024.||
0611|156|A|Copyright(c) 2025 First Databank, Inc.||
0611|157|B|||
0612|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0612|002|Z|does NOT have all possible information about this product. This||
0612|003|Z|information does not assure that this product is safe, effective,||
0612|004|Z|or appropriate for you. This information is not individual||
0612|005|Z|medical advice and does not substitute for the advice of your||
0612|006|Z|health care professional. Always ask your health care||
0612|007|Z|professional for complete information about this product and your||
0612|008|Z|specific health needs.||
0612|009|B|||
0612|010|T|NYSTATIN - TOPICAL||
0612|011|F|(NYE-stat-in)||
0612|012|B|||
0612|013|C|COMMON BRAND NAME(S): Mycostatin||
0612|014|B|||
0612|015|U|USES:  Nystatin is used to treat fungal skin infections. Nystatin||
0612|016|U|is an antifungal that works by stopping the growth of fungus.||
0612|017|B|||
0612|018|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0612|019|H|thoroughly dry the area to be treated. Apply this medication to||
0612|020|H|the affected skin as directed by your doctor, usually twice a||
0612|021|H|day. The dosage and length of treatment depends on the type of||
0612|022|H|infection being treated. Do not apply this more often than||
0612|023|H|prescribed.||
0612|024|H|   Apply enough medication to cover the affected area and some of||
0612|025|H|the surrounding skin. After applying this medication, wash your||
0612|026|H|hands unless you are using this medication to treat the hands. Do||
0612|027|H|not wrap, cover or bandage the area unless directed to do so by||
0612|028|H|your doctor. If used in the diaper area on an infant, do not use||
0612|029|H|tight-fitting diapers or plastic pants.||
0612|030|H|   Do not apply this medication in the eyes, nose, mouth, or||
0612|031|H|vagina.||
0612|032|H|   Use this medication regularly in order to get the most benefit||
0612|033|H|from it. Remember to use it at the same times each day.||
0612|034|H|   Continue to use this medication until the full prescribed||
0612|035|H|amount is finished, even if symptoms disappear after a few days.||
0612|036|H|Stopping the medication too early may result in a return of the||
0612|037|H|infection.||
0612|038|H|   Tell your doctor if your condition lasts after 2 weeks of||
0612|039|H|treatment or gets worse at any time.||
0612|040|B|||
0612|041|S|SIDE EFFECTS:  Skin irritation or redness may occur. If either of||
0612|042|S|these effects last or get worse, notify your doctor or pharmacist||
0612|043|S|promptly.||
0612|044|S|   Remember that this medication has been prescribed because your||
0612|045|S|doctor has judged that the benefit to you is greater than the||
0612|046|S|risk of side effects. Many people using this medication do not||
0612|047|S|have serious side effects.||
0612|048|S|   A very serious allergic reaction to this drug is rare.||
0612|049|S|However, get medical help right away if you notice any symptoms||
0612|050|S|of a serious allergic reaction, including: rash, itching/swelling||
0612|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0612|052|S|breathing.||
0612|053|S|   This is not a complete list of possible side effects. If you||
0612|054|S|notice other effects not listed above, contact your doctor or||
0612|055|S|pharmacist.||
0612|056|S|   In the US -||
0612|057|S|   Call your doctor for medical advice about side effects. You||
0612|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0612|059|S|www.fda.gov/medwatch.||
0612|060|S|   In Canada - Call your doctor for medical advice about side||
0612|061|S|effects. You may report side effects to Health Canada at||
0612|062|S|1-866-234-2345.||
0612|063|B|||
0612|064|P|PRECAUTIONS:  Before using nystatin, tell your doctor or||
0612|065|P|pharmacist if you are allergic to it; or if you have any other||
0612|066|P|allergies. This product may contain inactive ingredients, which||
0612|067|P|can cause allergic reactions or other problems. Talk to your||
0612|068|P|pharmacist for more details. .||
0612|069|P|   Before using this medication, tell your doctor or pharmacist||
0612|070|P|your medical history.||
0612|071|P|   Before having surgery, tell your doctor or dentist about all||
0612|072|P|the products you use (including prescription drugs,||
0612|073|P|nonprescription drugs, and herbal products).||
0612|074|P|   During pregnancy, this medication should be used only when||
0612|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
0612|076|P|   It is unknown if this drug passes into breast milk. Consult||
0612|077|P|your doctor before breastfeeding.||
0612|078|B|||
0612|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0612|080|I|medications work or increase your risk for serious side effects.||
0612|081|I|This document does not contain all possible drug interactions.||
0612|082|I|Keep a list of all the products you use (including||
0612|083|I|prescription/nonprescription drugs and herbal products) and share||
0612|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
0612|085|I|the dosage of any medicines without your doctor's approval.||
0612|086|B|||
0612|087|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0612|088|O|has overdosed and has serious symptoms such as passing out or||
0612|089|O|trouble breathing, call 911. Otherwise, call a poison control||
0612|090|O|center right away. US residents can call 1-800-222-1222. Canada||
0612|091|O|residents can call 1-844-764-7669. Symptoms that may occur after||
0612|092|O|swallowing include: nausea, vomiting or stomach upset.||
0612|093|B|||
0612|094|N|NOTES:  Do not share this medication with others.||
0612|095|N|   This medication has been prescribed for your current condition||
0612|096|N|only. Do not use it later for another infection unless your||
0612|097|N|doctor tells you to.||
0612|098|B|||
0612|099|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0612|100|D|If it is near the time of the next dose, skip the missed dose.||
0612|101|D|Use your next dose at the regular time. Do not double the dose to||
0612|102|D|catch up.||
0612|103|B|||
0612|104|R|STORAGE:  Store at room temperature. Keep all medications away||
0612|105|R|from children and pets.||
0612|106|R|   Do not flush medications down the toilet or pour them into a||
0612|107|R|drain unless instructed to do so. Properly discard this product||
0612|108|R|when it is expired or no longer needed. Consult your pharmacist||
0612|109|R|or local waste disposal company.||
0612|110|B|||
0612|111|A|Information last revised May 2024.||
0612|112|A|Copyright(c) 2025 First Databank, Inc.||
0612|113|B|||
0613|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0613|002|Z|does NOT have all possible information about this product. This||
0613|003|Z|information does not assure that this product is safe, effective,||
0613|004|Z|or appropriate for you. This information is not individual||
0613|005|Z|medical advice and does not substitute for the advice of your||
0613|006|Z|health care professional. Always ask your health care||
0613|007|Z|professional for complete information about this product and your||
0613|008|Z|specific health needs.||
0613|009|B|||
0613|010|T|RANOLAZINE EXTENDED-RELEASE - ORAL||
0613|011|F|(ra-NOE-la-zeen)||
0613|012|B|||
0613|013|C|COMMON BRAND NAME(S): Ranexa||
0613|014|B|||
0613|015|U|USES:  Ranolazine is used to treat a certain type of chest pain||
0613|016|U|(chronic angina). It decreases how often you may get chest pain||
0613|017|U|and may help to increase your ability to exercise.||
0613|018|U|   Ranolazine works differently than other drugs for angina, so||
0613|019|U|it can be used with your other angina medications (including||
0613|020|U|nitrates, calcium channel blockers such as amlodipine, beta||
0613|021|U|blockers such as metoprolol). It is thought to work by improving||
0613|022|U|how well the heart uses oxygen so that it can do more work with||
0613|023|U|less oxygen.||
0613|024|B|||
0613|025|V|OTHER USES:  This section contains uses of this drug that are not||
0613|026|V|listed in the approved professional labeling for the drug but||
0613|027|V|that may be prescribed by your health care professional. Use this||
0613|028|V|drug for a condition that is listed in this section only if it||
0613|029|V|has been so prescribed by your health care professional.||
0613|030|V|   This medication may also be used for irregular heartbeat.||
0613|031|B|||
0613|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0613|033|H|from your pharmacist before you start taking ranolazine and each||
0613|034|H|time you get a refill. If you have any questions, ask your doctor||
0613|035|H|or pharmacist.||
0613|036|H|   Take this medication by mouth with or without food as directed||
0613|037|H|by your doctor, usually twice daily. Swallow this medication||
0613|038|H|whole. Do not crush, chew, or split tablets. Doing so can release||
0613|039|H|all of the drug at once, increasing the risk of side effects.||
0613|040|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0613|041|H|using this medication unless your doctor or pharmacist says you||
0613|042|H|may do so safely. Grapefruit can increase the chance of side||
0613|043|H|effects with this medicine. Ask your doctor or pharmacist for||
0613|044|H|more details.||
0613|045|H|   The dosage is based on your medical condition, response to||
0613|046|H|treatment, and other medications you may be taking. Be sure to||
0613|047|H|tell your doctor and pharmacist about all the products you use||
0613|048|H|(including prescription drugs, nonprescription drugs, and herbal||
0613|049|H|products). Do not take more of this medication than your doctor||
0613|050|H|prescribes.||
0613|051|H|   Use this medication regularly in order to get the most benefit||
0613|052|H|from it. To help you remember, take it at the same times each||
0613|053|H|day. This medication must be taken regularly to be effective. It||
0613|054|H|should not be used to treat angina when it occurs. Use other||
0613|055|H|medications (such as sublingual nitroglycerin) to relieve an||
0613|056|H|angina attack as directed by your doctor. Consult your doctor or||
0613|057|H|pharmacist for details.||
0613|058|H|   Tell your doctor if your condition does not get better or if||
0613|059|H|it gets worse (such as if your chest pain happens more often).||
0613|060|B|||
0613|061|S|SIDE EFFECTS:  Dizziness, headache, lightheadedness, nausea,||
0613|062|S|tiredness, and constipation may occur. If any of these effects||
0613|063|S|last or get worse, notify your doctor or pharmacist promptly.||
0613|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
0613|065|S|slowly when rising from a sitting or lying position.||
0613|066|S|   Remember that this medication has been prescribed because your||
0613|067|S|doctor has judged that the benefit to you is greater than the||
0613|068|S|risk of side effects. Many people using this medication do not||
0613|069|S|have serious side effects.||
0613|070|S|   Tell your doctor right away if you have any serious side||
0613|071|S|effects, including: signs of kidney problems (such as change in||
0613|072|S|the amount of urine).||
0613|073|S|   Get medical help right away if you have any very serious side||
0613|074|S|effects, including: fainting, severe dizziness, fast/irregular||
0613|075|S|heartbeat.||
0613|076|S|   A very serious allergic reaction to this drug is rare.||
0613|077|S|However, get medical help right away if you notice any symptoms||
0613|078|S|of a serious allergic reaction, including: rash, itching/swelling||
0613|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0613|080|S|breathing.||
0613|081|S|   This is not a complete list of possible side effects. If you||
0613|082|S|notice other effects not listed above, contact your doctor or||
0613|083|S|pharmacist.||
0613|084|S|   In the US -||
0613|085|S|   Call your doctor for medical advice about side effects. You||
0613|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0613|087|S|www.fda.gov/medwatch.||
0613|088|S|   In Canada - Call your doctor for medical advice about side||
0613|089|S|effects. You may report side effects to Health Canada at||
0613|090|S|1-866-234-2345.||
0613|091|B|||
0613|092|P|PRECAUTIONS:  Before taking ranolazine, tell your doctor or||
0613|093|P|pharmacist if you are allergic to it; or if you have any other||
0613|094|P|allergies. This product may contain inactive ingredients, which||
0613|095|P|can cause allergic reactions or other problems. Talk to your||
0613|096|P|pharmacist for more details.||
0613|097|P|   Before using this medication, tell your doctor or pharmacist||
0613|098|P|your medical history, especially of: liver problems (such as||
0613|099|P|cirrhosis), kidney problems.||
0613|100|P|   Ranolazine may cause a condition that affects the heart rhythm||
0613|101|P|(QT prolongation). QT prolongation can rarely cause serious||
0613|102|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0613|103|P|as severe dizziness, fainting) that need medical attention right||
0613|104|P|away.||
0613|105|P|   The risk of QT prolongation may be increased if you have||
0613|106|P|certain medical conditions or are taking other drugs that may||
0613|107|P|cause QT prolongation. Before using ranolazine, tell your doctor||
0613|108|P|or pharmacist of all the drugs you take and if you have any of||
0613|109|P|the following conditions: certain heart problems (heart failure,||
0613|110|P|slow heartbeat, QT prolongation in the EKG), family history of||
0613|111|P|certain heart problems (QT prolongation in the EKG, sudden||
0613|112|P|cardiac death).||
0613|113|P|   Low levels of potassium or magnesium in the blood may also||
0613|114|P|increase your risk of QT prolongation. This risk may increase if||
0613|115|P|you use certain drugs (such as diuretics/"water pills") or if you||
0613|116|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0613|117|P|Talk to your doctor about using ranolazine safely.||
0613|118|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0613|119|P|can make you more dizzy. Do not drive, use machinery, or do||
0613|120|P|anything that needs alertness until you can do it safely. Limit||
0613|121|P|alcoholic beverages. Talk to your doctor if you are using||
0613|122|P|marijuana (cannabis).||
0613|123|P|   Before having surgery, tell your doctor or dentist about all||
0613|124|P|the products you use (including prescription drugs,||
0613|125|P|nonprescription drugs, and herbal products).||
0613|126|P|   Older adults may be more sensitive to the side effects of this||
0613|127|P|drug, especially QT prolongation (see above).||
0613|128|P|   During pregnancy, this medication should be used only when||
0613|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
0613|130|P|   It is unknown if this medication passes into breast milk.||
0613|131|P|Consult your doctor before breastfeeding.||
0613|132|B|||
0613|133|I|DRUG INTERACTIONS:  See also How to Use section.||
0613|134|I|   Drug interactions may change how your medications work or||
0613|135|I|increase your risk for serious side effects. This document does||
0613|136|I|not contain all possible drug interactions. Keep a list of all||
0613|137|I|the products you use (including prescription/nonprescription||
0613|138|I|drugs and herbal products) and share it with your doctor and||
0613|139|I|pharmacist. Do not start, stop, or change the dosage of any||
0613|140|I|medicines without your doctor's approval.||
0613|141|I|   Other medications can affect the removal of ranolazine from||
0613|142|I|your body, which may affect how ranolazine works. Examples||
0613|143|I|include azole antifungals (such as itraconazole, ketoconazole),||
0613|144|I|clarithromycin, cobicistat, nefazodone, HIV protease inhibitors||
0613|145|I|(such as nelfinavir), rifamycins (such as rifabutin, rifampin),||
0613|146|I|ritonavir, drugs used to treat seizures (such as carbamazepine,||
0613|147|I|phenobarbital, phenytoin), St. John's wort, among others.||
0613|148|B|||
0613|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0613|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0613|151|O|poison control center right away. US residents can call||
0613|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0613|153|O|Symptoms of overdose may include: severe dizziness/fainting,||
0613|154|O|fast/irregular/very slow heartbeat, mental/mood changes (such as||
0613|155|O|confusion, hallucinations), vomiting, severe tremor,||
0613|156|O|unsteadiness.||
0613|157|B|||
0613|158|N|NOTES:  Do not share this medication with others.||
0613|159|N|   Lab and/or medical tests (such as kidney function) may be done||
0613|160|N|while you are taking this medication. Keep all medical and lab||
0613|161|N|appointments. Consult your doctor for more details.||
0613|162|B|||
0613|163|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
0613|164|D|next dose at the regular time. Do not double the dose to catch||
0613|165|D|up.||
0613|166|B|||
0613|167|R|STORAGE:  Store at room temperature away from light and moisture.||
0613|168|R|Do not store in the bathroom. Keep all medications away from||
0613|169|R|children and pets.||
0613|170|R|   Do not flush medications down the toilet or pour them into a||
0613|171|R|drain unless instructed to do so. Properly discard this product||
0613|172|R|when it is expired or no longer needed. Consult your pharmacist||
0613|173|R|or local waste disposal company.||
0613|174|B|||
0613|175|M|MEDICAL ALERT:  Your condition can cause complications in a||
0613|176|M|medical emergency. For information about enrolling in MedicAlert,||
0613|177|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0613|178|B|||
0613|179|A|Information last revised April 2025.||
0613|180|A|Copyright(c) 2025 First Databank, Inc.||
0613|181|B|||
0614|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0614|002|Z|does NOT have all possible information about this product. This||
0614|003|Z|information does not assure that this product is safe, effective,||
0614|004|Z|or appropriate for you. This information is not individual||
0614|005|Z|medical advice and does not substitute for the advice of your||
0614|006|Z|health care professional. Always ask your health care||
0614|007|Z|professional for complete information about this product and your||
0614|008|Z|specific health needs.||
0614|009|B|||
0614|010|T|PHENELZINE - ORAL||
0614|011|F|(FEN-el-zeen)||
0614|012|B|||
0614|013|C|COMMON BRAND NAME(S): Nardil||
0614|014|B|||
0614|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0614|016|W|of conditions, including depression and other mental/mood||
0614|017|W|disorders. These medications can help prevent suicidal||
0614|018|W|thoughts/attempts and provide other important benefits. However,||
0614|019|W|studies have shown that a small number of people (especially||
0614|020|W|people younger than 25) who take antidepressants for any||
0614|021|W|condition may experience worsening depression, other mental/mood||
0614|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0614|023|W|talk with the doctor about the risks and benefits of||
0614|024|W|antidepressant medication (especially for people younger than||
0614|025|W|25), even if treatment is not for a mental/mood condition.||
0614|026|W|   Tell the doctor right away if you notice worsening||
0614|027|W|depression/other psychiatric conditions, unusual behavior changes||
0614|028|W|(including possible suicidal thoughts/attempts), or other||
0614|029|W|mental/mood changes (including new/worsening anxiety, panic||
0614|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0614|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0614|032|W|especially watchful for these symptoms when a new antidepressant||
0614|033|W|is started or when the dose is changed.||
0614|034|B|||
0614|035|U|USES:  This medication is used to treat depression. Phenelzine||
0614|036|U|belongs to a class of drugs known as monoamine oxidase inhibitors||
0614|037|U|(MAO inhibitors). It works by helping to restore the balance of||
0614|038|U|certain natural substances in the brain.||
0614|039|B|||
0614|040|V|OTHER USES:  This section contains uses of this drug that are not||
0614|041|V|listed in the approved professional labeling for the drug but||
0614|042|V|that may be prescribed by your health care professional. Use this||
0614|043|V|drug for a condition that is listed in this section only if it||
0614|044|V|has been so prescribed by your health care professional.||
0614|045|V|   This medication may also be used for anxiety and social||
0614|046|V|anxiety disorder (social phobia).||
0614|047|B|||
0614|048|H|HOW TO USE:  Read the Medication Guide available from your||
0614|049|H|pharmacist before you start using phenelzine and each time you||
0614|050|H|get a refill. If you have any questions, consult your doctor or||
0614|051|H|pharmacist.||
0614|052|H|   Take this medication by mouth with or without food as directed||
0614|053|H|by your doctor, usually 1 to 3 times a day. The dosage is based||
0614|054|H|on your medical condition and response to treatment.||
0614|055|H|   To reduce your risk of side effects, your doctor may start you||
0614|056|H|at a low dose and gradually increase your dose. Once your||
0614|057|H|condition improves and you are better for a while, your doctor||
0614|058|H|may work with you to reduce your regular dose. Follow your||
0614|059|H|doctor's instructions carefully. Do not take more or less||
0614|060|H|medication or take it more often than prescribed. Your condition||
0614|061|H|will not improve any faster and your risk of side effects will||
0614|062|H|increase.||
0614|063|H|   Use this medication regularly in order to get the most benefit||
0614|064|H|from it. To help you remember, use it at the same time(s) each||
0614|065|H|day. It may take several weeks for the full benefits of this||
0614|066|H|medication to be noticed. Do not stop taking this medication||
0614|067|H|without consulting your doctor.||
0614|068|H|   Caffeine can increase the side effects of this medication.||
0614|069|H|Avoid drinking large amounts of beverages containing caffeine||
0614|070|H|(coffee, tea, colas), eating large amounts of chocolate, or||
0614|071|H|taking nonprescription products that contain caffeine.||
0614|072|H|   To prevent a very serious high blood pressure reaction, it is||
0614|073|H|very important that you follow a special diet recommended by your||
0614|074|H|doctor or dietician to limit your intake of tyramine while you||
0614|075|H|are taking this medicine and for at least 2 weeks after the last||
0614|076|H|dose. Avoid foods and beverages that are high in tyramine,||
0614|077|H|including aged cheeses, dried/aged meats and sausages (such as||
0614|078|H|salami, liverwurst), preserved fish (such as pickled herring),||
0614|079|H|products that contain large amounts of yeast (such as bouillon||
0614|080|H|cubes, powdered soup/gravy, homemade or sourdough bread),||
0614|081|H|fermented foods (such as sauerkraut, kim chee), most soybean||
0614|082|H|products (such as soy sauce, tofu), broad/fava beans, red wine,||
0614|083|H|sherry, tap beers, and vermouth. Consult your doctor or dietician||
0614|084|H|for more details and a complete list of other foods that contain||
0614|085|H|tyramine which you should limit or avoid.||
0614|086|H|   If you suddenly stop using this medication, you may have||
0614|087|H|withdrawal symptoms (such as restlessness, confusion,||
0614|088|H|hallucinations, headache, weakness, and diarrhea). To help||
0614|089|H|prevent withdrawal, your doctor may lower your dose slowly.||
0614|090|H|Withdrawal is more likely if you have used phenelzine for a long||
0614|091|H|time or in high doses. Tell your doctor or pharmacist right away||
0614|092|H|if you have withdrawal.||
0614|093|H|   Tell your doctor if your condition lasts or gets worse.||
0614|094|B|||
0614|095|S|SIDE EFFECTS:  See also Warning section.||
0614|096|S|   Dizziness, drowsiness, tiredness, weakness, problems sleeping,||
0614|097|S|constipation, and dry mouth may occur. If any of these effects||
0614|098|S|last or get worse, tell your doctor or pharmacist promptly.||
0614|099|S|   To reduce the risk of dizziness and lightheadedness, get up||
0614|100|S|slowly when rising from a sitting or lying position.||
0614|101|S|   Remember that this medication has been prescribed because your||
0614|102|S|doctor has judged that the benefit to you is greater than the||
0614|103|S|risk of side effects. Many people using this medication do not||
0614|104|S|have serious side effects.||
0614|105|S|   Tell your doctor right away if you have any serious side||
0614|106|S|effects, including: fainting, mental/mood changes (such as||
0614|107|S|agitation, confusion), muscle stiffness, changes in sexual||
0614|108|S|ability/interest, shaking (tremor), shivering, swollen||
0614|109|S|ankles/legs, unusual weight gain, eye pain/swelling/redness,||
0614|110|S|vision changes (such as double/blurred vision), signs of liver||
0614|111|S|problems (such as nausea/vomiting that doesn't stop,||
0614|112|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
0614|113|S|seizures.||
0614|114|S|   This drug may rarely cause an attack of extremely high blood||
0614|115|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
0614|116|S|food interactions can increase this risk (See also How to Use and||
0614|117|S|Drug Interaction sections). Stop taking phenelzine and get||
0614|118|S|medical help right away if any of these serious side effects||
0614|119|S|occur: frequent/severe headache, fast/slow/irregular/pounding||
0614|120|S|heartbeat, chest pain, neck stiffness/soreness, severe||
0614|121|S|nausea/vomiting, sweating/clammy skin (sometimes with fever),||
0614|122|S|widened pupils, sudden sensitivity to light (photophobia).||
0614|123|S|   This medication may increase serotonin and rarely cause a very||
0614|124|S|serious condition called serotonin syndrome/toxicity. The risk||
0614|125|S|increases if you are also taking other drugs that increase||
0614|126|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0614|127|S|take (see Drug Interactions section). Get medical help right away||
0614|128|S|if you develop some of the following symptoms: fast heartbeat,||
0614|129|S|hallucinations, loss of coordination, severe dizziness, severe||
0614|130|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0614|131|S|unusual agitation/restlessness.||
0614|132|S|   A very serious allergic reaction to this drug is rare.||
0614|133|S|However, get medical help right away if you notice any symptoms||
0614|134|S|of a serious allergic reaction, including: rash, itching/swelling||
0614|135|S|(especially of the face/tongue/throat), dizziness, trouble||
0614|136|S|breathing.||
0614|137|S|   This is not a complete list of possible side effects. If you||
0614|138|S|notice other effects not listed above, contact your doctor or||
0614|139|S|pharmacist.||
0614|140|S|   In the US -||
0614|141|S|   Call your doctor for medical advice about side effects. You||
0614|142|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0614|143|S|www.fda.gov/medwatch.||
0614|144|S|   In Canada - Call your doctor for medical advice about side||
0614|145|S|effects. You may report side effects to Health Canada at||
0614|146|S|1-866-234-2345.||
0614|147|B|||
0614|148|P|PRECAUTIONS:  Before taking phenelzine, tell your doctor or||
0614|149|P|pharmacist if you are allergic to it; or if you have any other||
0614|150|P|allergies. This product may contain inactive ingredients, which||
0614|151|P|can cause allergic reactions or other problems. Talk to your||
0614|152|P|pharmacist for more details.||
0614|153|P|   Before using this medication, tell your doctor or pharmacist||
0614|154|P|your medical history, especially of: a certain adrenal gland||
0614|155|P|tumor (pheochromocytoma), cerebrovascular disease (such as||
0614|156|P|stroke), heart problems (such as heart failure, heart attack,||
0614|157|P|coronary artery disease), high blood pressure, history of||
0614|158|P|severe/frequent headaches, liver problems, kidney disease,||
0614|159|P|personal/family history of mental/mood disorders (such as||
0614|160|P|schizophrenia, bipolar disorder), diabetes, certain nervous||
0614|161|P|system diseases (Parkinson's syndrome, seizures), overactive||
0614|162|P|thyroid (hyperthyroidism), personal/family history of glaucoma||
0614|163|P|(angle-closure type).||
0614|164|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0614|165|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0614|166|P|machinery, or do anything that needs alertness until you can do||
0614|167|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0614|168|P|are using marijuana (cannabis).||
0614|169|P|   Before having surgery or any procedures requiring use of||
0614|170|P|contrast dye (such as myelography), tell your doctor or dentist||
0614|171|P|about all the products you use (including prescription drugs,||
0614|172|P|nonprescription drugs, and herbal products). You may need to stop||
0614|173|P|taking this drug beforehand. Follow your doctor's instructions||
0614|174|P|carefully.||
0614|175|P|   If you have heart disease, this medication may mask chest||
0614|176|P|pain. Avoid strenuous exercise while taking this medication.||
0614|177|P|   If you have diabetes, phenelzine may lower your blood sugar.||
0614|178|P|Check your blood sugar regularly as directed and share the||
0614|179|P|results with your doctor. Tell your doctor right away if you have||
0614|180|P|symptoms of low blood sugar such as sudden sweating, shaking,||
0614|181|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
0614|182|P|hands/feet. Your doctor may need to adjust your diabetes||
0614|183|P|medication, exercise program, or diet.||
0614|184|P|   Older adults may be more sensitive to the side effects of this||
0614|185|P|drug, especially the effects on blood pressure.||
0614|186|P|   During pregnancy, this medication should be used only when||
0614|187|P|clearly needed. Discuss the risks and benefits with your doctor.||
0614|188|P|   Since untreated mental/mood problems (such as depression) can||
0614|189|P|be a serious condition, do not stop taking this medication unless||
0614|190|P|directed by your doctor. If you are planning pregnancy, become||
0614|191|P|pregnant, or think you may be pregnant, immediately discuss with||
0614|192|P|your doctor the benefits and risks of using this medication||
0614|193|P|during pregnancy.||
0614|194|P|   It is unknown if this drug passes into breast milk. Consult||
0614|195|P|your doctor before breastfeeding.||
0614|196|B|||
0614|197|I|DRUG INTERACTIONS:  See also How to Use section.||
0614|198|I|   Drug interactions may change how your medications work or||
0614|199|I|increase your risk for serious side effects. This document does||
0614|200|I|not contain all possible drug interactions. Keep a list of all||
0614|201|I|the products you use (including prescription/nonprescription||
0614|202|I|drugs and herbal products) and share it with your doctor and||
0614|203|I|pharmacist. Do not start, stop, or change the dosage of any||
0614|204|I|medicines without your doctor's approval.||
0614|205|I|   Some products that may interact with this drug include: other||
0614|206|I|antidepressants (including maprotiline, mirtazapine, nefazodone,||
0614|207|I|TCAs such as amitriptyline/nortriptyline), appetite suppressants||
0614|208|I|(such as diethylpropion), drugs for attention deficit disorder||
0614|209|I|(such as atomoxetine, methylphenidate), apraclonidine, bupropion,||
0614|210|I|buspirone, carbamazepine, cyclobenzaprine, deutetrabenazine,||
0614|211|I|dextromethorphan, certain drugs for high blood pressure (such as||
0614|212|I|guanethidine, methyldopa, beta blockers such as atenolol,||
0614|213|I|clonidine, rauwolfia alkaloids), other MAO inhibitors||
0614|214|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0614|215|I|moclobemide, procarbazine, rasagiline, safinamide, selegiline,||
0614|216|I|tranylcypromine), metoclopramide, certain opioid medications||
0614|217|I|(such as fentanyl, meperidine, methadone, tapentadol), certain||
0614|218|I|drugs for Parkinson's (such as entacapone, levodopa, tolcapone),||
0614|219|I|street drugs (such as LSD, mescaline), tetrabenazine, "triptan"||
0614|220|I|migraine drugs (such as sumatriptan, rizatriptan), tramadol,||
0614|221|I|tyrosine, tryptophan, valbenazine.||
0614|222|I|   The risk of serotonin syndrome/toxicity increases if you are||
0614|223|I|also taking other drugs that increase serotonin. Examples include||
0614|224|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
0614|225|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0614|226|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0614|227|I|serotonin syndrome/toxicity may be more likely when you start or||
0614|228|I|increase the dose of these drugs.||
0614|229|I|   Tell your doctor or pharmacist if you are using any of these||
0614|230|I|medications before, during, or within 2 weeks after treatment||
0614|231|I|with phenelzine. Tell your doctor or pharmacist if you have taken||
0614|232|I|fluoxetine during at least 5 weeks before starting phenelzine.||
0614|233|I|Discuss with your doctor how much time to wait between starting||
0614|234|I|or stopping any of these drugs and taking phenelzine.||
0614|235|I|   Before using phenelzine, report the use of drugs that may||
0614|236|I|increase the risk of extremely high blood pressure (hypertensive||
0614|237|I|crisis) when combined with phenelzine, including herbal products||
0614|238|I|(such as ephedra/ma huang), nasal decongestants (such as||
0614|239|I|phenylephrine, pseudoephedrine), and stimulants (such as||
0614|240|I|amphetamines, ephedrine, epinephrine, phenylalanine). Phenelzine||
0614|241|I|should not be used with any of these medications. Talk to your||
0614|242|I|doctor or pharmacist for more details.||
0614|243|I|   Tell your doctor or pharmacist if you are taking other||
0614|244|I|products that cause drowsiness such as opioid pain or cough||
0614|245|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0614|246|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0614|247|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0614|248|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0614|249|I|diphenhydramine).||
0614|250|I|   Check the labels on all your medicines (such as allergy,||
0614|251|I|cough-and-cold products, decongestants, diet pills) because they||
0614|252|I|may contain dextromethorphan, decongestants, stimulants, or||
0614|253|I|ingredients that cause drowsiness. Ask your pharmacist about the||
0614|254|I|safe use of those products.||
0614|255|B|||
0614|256|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0614|257|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0614|258|O|poison control center right away. US residents can call||
0614|259|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0614|260|B|||
0614|261|N|NOTES:  Do not share this medication with others.||
0614|262|N|   Lab and/or medical tests (such as blood pressure, liver||
0614|263|N|function) should be done while you are taking this medication.||
0614|264|N|Keep all medical and lab appointments. Consult your doctor for||
0614|265|N|more details.||
0614|266|B|||
0614|267|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0614|268|D|remember. If it is within 2 hours of the next dose, skip the||
0614|269|D|missed dose. Take your next dose at the regular time. Do not||
0614|270|D|double the dose to catch up.||
0614|271|B|||
0614|272|R|STORAGE:  Store at room temperature away from light and moisture.||
0614|273|R|Do not store in the bathroom. Keep all medications away from||
0614|274|R|children and pets.||
0614|275|R|   Do not flush medications down the toilet or pour them into a||
0614|276|R|drain unless instructed to do so. Properly discard this product||
0614|277|R|when it is expired or no longer needed. Consult your pharmacist||
0614|278|R|or local waste disposal company.||
0614|279|B|||
0614|280|M|MEDICAL ALERT:  Your condition can cause complications in a||
0614|281|M|medical emergency. For information about enrolling in MedicAlert,||
0614|282|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0614|283|B|||
0614|284|A|Information last revised November 2025.||
0614|285|A|Copyright(c) 2025 First Databank, Inc.||
0614|286|B|||
0615|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0615|002|Z|does NOT have all possible information about this product. This||
0615|003|Z|information does not assure that this product is safe, effective,||
0615|004|Z|or appropriate for you. This information is not individual||
0615|005|Z|medical advice and does not substitute for the advice of your||
0615|006|Z|health care professional. Always ask your health care||
0615|007|Z|professional for complete information about this product and your||
0615|008|Z|specific health needs.||
0615|009|B|||
0615|010|T|INSULIN POWDER INHALER - ORAL INHALATION||
0615|011|F|(IN-su-lin)||
0615|012|B|||
0615|013|C|COMMON BRAND NAME(S): Afrezza||
0615|014|B|||
0615|015|W|WARNING:  This medication can cause trouble breathing in people||
0615|016|W|with long-term (chronic) lung disease (such as asthma, chronic||
0615|017|W|obstructive pulmonary disease-COPD). This medication should not||
0615|018|W|be used by people with chronic lung problems. Tell your doctor||
0615|019|W|right away if you have cough that doesn't go away, trouble||
0615|020|W|breathing, shortness of breath, or wheezing.||
0615|021|W|   Your doctor will check your lung function before you start||
0615|022|W|using this medication. (See also Notes section.)||
0615|023|B|||
0615|024|U|USES:  Inhaled insulin powder is used with a proper diet and||
0615|025|U|exercise program to control high blood sugar in people with||
0615|026|U|diabetes. Controlling high blood sugar helps prevent kidney||
0615|027|U|damage, blindness, nerve problems, loss of limbs, and sexual||
0615|028|U|function problems. Proper control of diabetes may also lessen||
0615|029|U|your risk of a heart attack or stroke.||
0615|030|U|   This man-made insulin product is the same as human insulin. It||
0615|031|U|replaces the insulin that your body would normally make. It is a||
0615|032|U|short-acting insulin. It works by helping blood sugar (glucose)||
0615|033|U|get into cells so your body can use it for energy. This product||
0615|034|U|is absorbed into the blood through your lungs. It starts working||
0615|035|U|faster and lasts for a shorter time than regular insulin injected||
0615|036|U|under the skin. It is usually used in combination with a medium-||
0615|037|U|or long-acting insulin product. This medication may also be used||
0615|038|U|alone or with other oral diabetes drugs (such as metformin).||
0615|039|B|||
0615|040|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
0615|041|H|Leaflet provided by your pharmacist before you start using||
0615|042|H|inhaled insulin and each time you get a refill. Follow the||
0615|043|H|illustrated directions for the proper use of this medication. If||
0615|044|H|you have any questions, ask your doctor, diabetes educator, or||
0615|045|H|pharmacist.||
0615|046|H|   This medication comes in cartridges in a blister package. Do||
0615|047|H|not try to open the cartridges. The inhaler opens the||
0615|048|H|blister/cartridge containing the insulin powder, allowing the||
0615|049|H|insulin to be inhaled. Bring the medication and inhaler to room||
0615|050|H|temperature before using. Follow your doctor's directions||
0615|051|H|carefully.||
0615|052|H|   Inhale this medication by mouth at the beginning of a meal as||
0615|053|H|directed by your doctor. Because inhaled insulin is fast-acting,||
0615|054|H|not eating immediately after inhaling a dose of this insulin may||
0615|055|H|lead to low blood sugar.||
0615|056|H|   The dosage is based on your medical condition and response to||
0615|057|H|treatment.||
0615|058|H|   Do not change brands or types of insulin without directions on||
0615|059|H|how to do so from your doctor.||
0615|060|H|   Use this medication regularly to get the most benefit from it.||
0615|061|H|To help you remember, use it at the same times each day.||
0615|062|H|   Check your blood sugar regularly as directed by your doctor.||
0615|063|H|Keep track of your results and share them with your doctor. This||
0615|064|H|is very important in order to determine the correct insulin dose.||
0615|065|H|   Tell your doctor if your condition does not get better or if||
0615|066|H|it gets worse (your blood sugar is too high or too low).||
0615|067|B|||
0615|068|S|SIDE EFFECTS:  See also Warning section.||
0615|069|S|   Weight gain, cough or throat pain/irritation may occur. If any||
0615|070|S|of these effects last or get worse, tell your doctor or||
0615|071|S|pharmacist promptly.||
0615|072|S|   Remember that this medication has been prescribed because your||
0615|073|S|doctor has judged that the benefit to you is greater than the||
0615|074|S|risk of side effects. Many people using this medication do not||
0615|075|S|have serious side effects.||
0615|076|S|   Tell your doctor right away if you have any serious side||
0615|077|S|effects, including: signs of low potassium level in the blood||
0615|078|S|(such as muscle cramps, weakness, irregular heartbeat).||
0615|079|S|   This medication can cause low blood sugar (hypoglycemia). This||
0615|080|S|may occur if you do not get enough calories from food or if you||
0615|081|S|do unusually heavy exercise. Symptoms of low blood sugar include||
0615|082|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
0615|083|S|dizziness, or tingling hands/feet. It is a good habit to carry||
0615|084|S|glucose tablets or gel to treat low blood sugar. If you don't||
0615|085|S|have these reliable forms of glucose, rapidly raise your blood||
0615|086|S|sugar by eating a quick source of sugar such as table sugar,||
0615|087|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
0615|088|S|doctor right away about the reaction and the use of this product.||
0615|089|S|To help prevent low blood sugar, eat meals on a regular schedule,||
0615|090|S|and do not skip meals. Check with your doctor or pharmacist to||
0615|091|S|find out what you should do if you miss a meal.||
0615|092|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0615|093|S|thirst/urination. If these symptoms occur, tell your doctor right||
0615|094|S|away. Your doctor may need to adjust your diabetes medication,||
0615|095|S|exercise program, or diet.||
0615|096|S|   A very serious allergic reaction to this drug is rare.||
0615|097|S|However, get medical help right away if you notice any symptoms||
0615|098|S|of a serious allergic reaction, including: rash, itching/swelling||
0615|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0615|100|S|breathing.||
0615|101|S|   This is not a complete list of possible side effects. If you||
0615|102|S|notice other effects not listed above, contact your doctor or||
0615|103|S|pharmacist.||
0615|104|S|   In the US -||
0615|105|S|   Call your doctor for medical advice about side effects. You||
0615|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0615|107|S|www.fda.gov/medwatch.||
0615|108|S|   In Canada - Call your doctor for medical advice about side||
0615|109|S|effects. You may report side effects to Health Canada at||
0615|110|S|1-866-234-2345.||
0615|111|B|||
0615|112|P|PRECAUTIONS:  See also Warning section.||
0615|113|P|   Before using inhaled insulin, tell your doctor or pharmacist||
0615|114|P|if you are allergic to it; or to other insulins; or if you have||
0615|115|P|any other allergies. This product may contain inactive||
0615|116|P|ingredients, which can cause allergic reactions or other||
0615|117|P|problems. Talk to your pharmacist for more details.||
0615|118|P|   Do not use this medication when you have low blood sugar.||
0615|119|P|   Before using this medication, tell your doctor or pharmacist||
0615|120|P|your medical history, especially of: smoking (either currently or||
0615|121|P|recently), kidney disease, liver disease, thyroid problems, lung||
0615|122|P|cancer.||
0615|123|P|   You may experience blurred vision, dizziness, or drowsiness||
0615|124|P|due to extremely low or high blood sugar. Do not drive, use||
0615|125|P|machinery, or do anything that needs alertness or clear vision||
0615|126|P|until you can do it safely.||
0615|127|P|   Limit alcohol while taking this medication because it can||
0615|128|P|increase your risk of developing low blood sugar.||
0615|129|P|   It may be harder to control your blood sugar when your body is||
0615|130|P|stressed (such as due to fever, infection, injury, or surgery).||
0615|131|P|Consult your doctor because this may require a change in your||
0615|132|P|treatment plan, medications, or blood sugar testing.||
0615|133|P|   Check your blood sugar before and after exercise. You may need||
0615|134|P|a snack before exercising.||
0615|135|P|   If traveling across time zones, ask your doctor about how to||
0615|136|P|adjust your insulin schedule. Take extra insulin with you.||
0615|137|P|   Before having surgery, tell your doctor or dentist about all||
0615|138|P|the products you use (including prescription drugs,||
0615|139|P|nonprescription drugs, and herbal products).||
0615|140|P|   Older adults may be more sensitive to the side effects of this||
0615|141|P|drug, especially low blood sugar.||
0615|142|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
0615|143|P|cause or worsen diabetes. Discuss a plan with your doctor for||
0615|144|P|managing your blood sugar while pregnant. Your doctor may change||
0615|145|P|your diabetes treatment during your pregnancy (such as diet and||
0615|146|P|medications including insulin).||
0615|147|P|   This medication passes into breast milk, but is unlikely to||
0615|148|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0615|149|P|Your insulin needs may change while breastfeeding.||
0615|150|B|||
0615|151|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0615|152|I|medications work or increase your risk for serious side effects.||
0615|153|I|This document does not contain all possible drug interactions.||
0615|154|I|Keep a list of all the products you use (including||
0615|155|I|prescription/nonprescription drugs and herbal products) and share||
0615|156|I|it with your doctor and pharmacist. Do not start, stop, or change||
0615|157|I|the dosage of any medicines without your doctor's approval.||
0615|158|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0615|159|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0615|160|I|heartbeat you would usually feel when your blood sugar falls too||
0615|161|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0615|162|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0615|163|I|   Many drugs can affect your blood sugar levels, making it more||
0615|164|I|difficult to control your blood sugar. Before you start, stop, or||
0615|165|I|change any medication, talk with your doctor or pharmacist about||
0615|166|I|how the medication may affect your blood sugar. Check your blood||
0615|167|I|sugar regularly as directed by your doctor. Tell your doctor||
0615|168|I|about the results and of any symptoms of high or low blood sugar.||
0615|169|I|(See also Side Effects section.) Your doctor may need to adjust||
0615|170|I|your diabetes medication, exercise program, or diet.||
0615|171|B|||
0615|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0615|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0615|174|O|poison control center right away. US residents can call||
0615|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0615|176|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
0615|177|O|sweating, loss of consciousness.||
0615|178|B|||
0615|179|N|NOTES:  Do not share this medication with others.||
0615|180|N|   Attend a diabetes education program to learn more about how to||
0615|181|N|manage your diabetes with medications, diet, exercise, and||
0615|182|N|regular medical exams.||
0615|183|N|   Learn the symptoms of high and low blood sugar and how to||
0615|184|N|treat low blood sugar. Check your blood sugar regularly as||
0615|185|N|directed.||
0615|186|N|   Lab and/or medical tests (such as lung/liver/kidney function,||
0615|187|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
0615|188|N|should be done before you start taking this medication and while||
0615|189|N|you are taking it. Keep all medical and lab appointments. Consult||
0615|190|N|your doctor for more details.||
0615|191|B|||
0615|192|D|MISSED DOSE:  It is very important to follow your insulin regimen||
0615|193|D|exactly. Ask your doctor ahead of time what you should do if you||
0615|194|D|miss a dose of insulin.||
0615|195|B|||
0615|196|R|STORAGE:  Store the unopened medication in the refrigerator. Once||
0615|197|R|opened, check the product package for instructions on how to||
0615|198|R|store your medication and inhaler, or ask your pharmacist.||
0615|199|R|Discard the inhaler after 15 days. Keep all medications away from||
0615|200|R|children and pets.||
0615|201|R|   Do not flush medications down the toilet or pour them into a||
0615|202|R|drain unless instructed to do so. Properly discard this product||
0615|203|R|when it is expired or no longer needed. Consult your pharmacist||
0615|204|R|or local waste disposal company.||
0615|205|B|||
0615|206|M|MEDICAL ALERT:  Your condition can cause complications in a||
0615|207|M|medical emergency. For information about enrolling in MedicAlert,||
0615|208|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0615|209|B|||
0615|210|A|Information last revised November 2025.||
0615|211|A|Copyright(c) 2025 First Databank, Inc.||
0615|212|B|||
0616|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0616|002|Z|does NOT have all possible information about this product. This||
0616|003|Z|information does not assure that this product is safe, effective,||
0616|004|Z|or appropriate for you. This information is not individual||
0616|005|Z|medical advice and does not substitute for the advice of your||
0616|006|Z|health care professional. Always ask your health care||
0616|007|Z|professional for complete information about this product and your||
0616|008|Z|specific health needs.||
0616|009|B|||
0616|010|T|TRANYLCYPROMINE - ORAL||
0616|011|F|(tran-il-SIP-roe-meen)||
0616|012|B|||
0616|013|C|COMMON BRAND NAME(S): Parnate||
0616|014|B|||
0616|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0616|016|W|of conditions, including depression and other mental/mood||
0616|017|W|disorders. These medications can help prevent suicidal||
0616|018|W|thoughts/attempts and provide other important benefits. However,||
0616|019|W|studies have shown that a small number of people (especially||
0616|020|W|people younger than 25) who take antidepressants for any||
0616|021|W|condition may experience worsening depression, other mental/mood||
0616|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0616|023|W|talk with the doctor about the risks and benefits of||
0616|024|W|antidepressant medication (especially for people younger than||
0616|025|W|25), even if treatment is not for a mental/mood condition.||
0616|026|W|   Tell the doctor right away if you notice worsening||
0616|027|W|depression/other psychiatric conditions, unusual behavior changes||
0616|028|W|(including possible suicidal thoughts/attempts), or other||
0616|029|W|mental/mood changes (including new/worsening anxiety, panic||
0616|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0616|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0616|032|W|especially watchful for these symptoms when a new antidepressant||
0616|033|W|is started or when the dose is changed.||
0616|034|W|   This drug may rarely cause an attack of extremely high blood||
0616|035|W|pressure (hypertensive crisis), which may be fatal. Many drug||
0616|036|W|interactions can increase this risk. Food and drinks that contain||
0616|037|W|tyramine can also increase this risk. See also Side Effects and||
0616|038|W|Drug Interactions sections. Check your blood pressure regularly.||
0616|039|W|Tell your doctor and pharmacist about all||
0616|040|W|prescription/nonprescription drugs and herbal products you take||
0616|041|W|before starting tranylcypromine. Ask them before starting any||
0616|042|W|other drugs while taking tranylcypromine, and even when you stop||
0616|043|W|taking tranylcypromine since it can still cause these||
0616|044|W|interactions for a period of time.||
0616|045|B|||
0616|046|U|USES:  This medication is used to treat depression.||
0616|047|U|Tranylcypromine belongs to a class of drugs known as monoamine||
0616|048|U|oxidase inhibitors (MAO inhibitors). It works by helping to||
0616|049|U|restore the balance of certain natural substances in the brain.||
0616|050|B|||
0616|051|H|HOW TO USE:  Read the Medication Guide provided by your||
0616|052|H|pharmacist before you start using tranylcypromine and each time||
0616|053|H|you get a refill. If you have any questions, ask your doctor or||
0616|054|H|pharmacist.||
0616|055|H|   Take this medication by mouth with or without food as directed||
0616|056|H|by your doctor, usually twice daily. The dosage is based on your||
0616|057|H|medical condition and response to treatment.||
0616|058|H|   To reduce your risk of side effects, your doctor may start you||
0616|059|H|at a low dose and gradually increase your dose. Once your||
0616|060|H|condition improves and you are better for a while, your doctor||
0616|061|H|may work with you to reduce your regular dose. Follow your||
0616|062|H|doctor's instructions carefully. Do not take more or less||
0616|063|H|medication or take it more often than prescribed. Your condition||
0616|064|H|will not improve any faster and your risk of side effects will||
0616|065|H|increase.||
0616|066|H|   Use this medication regularly in order to get the most benefit||
0616|067|H|from it. To help you remember, use it at the same time(s) each||
0616|068|H|day. It may take several weeks for the full benefits of this||
0616|069|H|medication to be noticed. Do not stop taking this medication||
0616|070|H|without consulting your doctor.||
0616|071|H|   Caffeine can increase the side effects of this medication.||
0616|072|H|Avoid drinking large amounts of beverages containing caffeine||
0616|073|H|(coffee, tea, colas), eating large amounts of chocolate, or||
0616|074|H|taking nonprescription products that contain caffeine.||
0616|075|H|   To prevent a very serious high blood pressure reaction, it is||
0616|076|H|very important that you follow a special diet recommended by your||
0616|077|H|doctor or dietician to limit your intake of tyramine while you||
0616|078|H|are taking this medicine and for at least 2 weeks after the last||
0616|079|H|dose. Avoid foods and beverages that are high in tyramine,||
0616|080|H|including aged cheeses, dried/aged meats and sausages (such as||
0616|081|H|salami, liverwurst), preserved fish (such as pickled herring),||
0616|082|H|products that contain large amounts of yeast (such as bouillon||
0616|083|H|cubes, powdered soup/gravy, homemade or sourdough bread),||
0616|084|H|fermented foods (such as sauerkraut, kim chee), most soybean||
0616|085|H|products (such as soy sauce, tofu), broad/fava beans, red wine,||
0616|086|H|sherry, tap beers, and vermouth. Consult your doctor or dietician||
0616|087|H|for more details and a complete list of other foods that contain||
0616|088|H|tyramine which you should limit or avoid.||
0616|089|H|   If you suddenly stop using this medication, you may have||
0616|090|H|withdrawal symptoms (such as restlessness, confusion,||
0616|091|H|hallucinations, headache, weakness, and diarrhea). To help||
0616|092|H|prevent withdrawal, your doctor may lower your dose slowly.||
0616|093|H|Withdrawal is more likely if you have used tranylcypromine for a||
0616|094|H|long time or in high doses. Tell your doctor or pharmacist right||
0616|095|H|away if you have withdrawal.||
0616|096|H|   Tell your doctor if your condition lasts or gets worse.||
0616|097|B|||
0616|098|S|SIDE EFFECTS:  See also Warning section.||
0616|099|S|   Dizziness, drowsiness, tiredness, weakness, problems sleeping,||
0616|100|S|constipation, and dry mouth may occur. If any of these effects||
0616|101|S|last or get worse, notify your doctor or pharmacist promptly.||
0616|102|S|   To reduce the risk of dizziness and lightheadedness, get up||
0616|103|S|slowly when rising from a sitting or lying position.||
0616|104|S|   Remember that this medication has been prescribed because your||
0616|105|S|doctor has judged that the benefit to you is greater than the||
0616|106|S|risk of side effects. Many people using this medication do not||
0616|107|S|have serious side effects.||
0616|108|S|   Tell your doctor right away if you have any serious side||
0616|109|S|effects, including: fainting, mental/mood changes (such as||
0616|110|S|agitation, confusion), muscle stiffness, changes in sexual||
0616|111|S|ability/interest, shaking (tremor), shivering, swollen||
0616|112|S|ankles/legs, unusual weight gain, eye pain/swelling/redness,||
0616|113|S|vision changes (such as double/blurred vision), signs of liver||
0616|114|S|problems (such as nausea/vomiting that doesn't stop,||
0616|115|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
0616|116|S|seizures.||
0616|117|S|   This drug may rarely cause an attack of extremely high blood||
0616|118|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
0616|119|S|food interactions can increase this risk (see How to Use and Drug||
0616|120|S|Interactions sections). Get medical help right away if any of||
0616|121|S|these serious side effects occur: severe headache,||
0616|122|S|fast/slow/irregular/pounding heartbeat, chest pain, neck||
0616|123|S|stiffness/soreness, severe nausea/vomiting, sweating/clammy skin||
0616|124|S|(sometimes with fever), widened pupils, sudden sensitivity to||
0616|125|S|light (photophobia).||
0616|126|S|   This medication may increase serotonin and rarely cause a very||
0616|127|S|serious condition called serotonin syndrome/toxicity. The risk||
0616|128|S|increases if you are also taking other drugs that increase||
0616|129|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0616|130|S|take (see Drug Interactions section). Get medical help right away||
0616|131|S|if you develop some of the following symptoms: fast heartbeat,||
0616|132|S|hallucinations, loss of coordination, severe dizziness, severe||
0616|133|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0616|134|S|unusual agitation/restlessness.||
0616|135|S|   A very serious allergic reaction to this drug is rare.||
0616|136|S|However, get medical help right away if you notice any symptoms||
0616|137|S|of a serious allergic reaction, including: rash, itching/swelling||
0616|138|S|(especially of the face/tongue/throat), dizziness, trouble||
0616|139|S|breathing.||
0616|140|S|   This is not a complete list of possible side effects. If you||
0616|141|S|notice other effects not listed above, contact your doctor or||
0616|142|S|pharmacist.||
0616|143|S|   In the US -||
0616|144|S|   Call your doctor for medical advice about side effects. You||
0616|145|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0616|146|S|www.fda.gov/medwatch.||
0616|147|S|   In Canada - Call your doctor for medical advice about side||
0616|148|S|effects. You may report side effects to Health Canada at||
0616|149|S|1-866-234-2345.||
0616|150|B|||
0616|151|P|PRECAUTIONS:  Before taking tranylcypromine, tell your doctor or||
0616|152|P|pharmacist if you are allergic to it; or if you have any other||
0616|153|P|allergies. This product may contain inactive ingredients, which||
0616|154|P|can cause allergic reactions or other problems. Talk to your||
0616|155|P|pharmacist for more details.||
0616|156|P|   Before using this medication, tell your doctor or pharmacist||
0616|157|P|your medical history, especially of: a certain adrenal gland||
0616|158|P|tumor (pheochromocytoma), cerebrovascular disease (such as||
0616|159|P|stroke), high blood pressure, heart problems (such as coronary||
0616|160|P|artery disease, chest pain, heart attack, heart failure),||
0616|161|P|severe/frequent headaches, mental/mood disorders (such as||
0616|162|P|schizophrenia, bipolar disorder), liver problems, kidney disease,||
0616|163|P|certain nervous system diseases (Parkinson's syndrome, seizures),||
0616|164|P|overactive thyroid (hyperthyroidism), personal/family history of||
0616|165|P|glaucoma (angle-closure type).||
0616|166|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0616|167|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0616|168|P|machinery, or do anything that needs alertness until you can do||
0616|169|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0616|170|P|are using marijuana (cannabis).||
0616|171|P|   Before having surgery or any procedures requiring use of||
0616|172|P|contrast dye (such as myelography), tell your doctor or dentist||
0616|173|P|about all the products you use (including prescription drugs,||
0616|174|P|nonprescription drugs, and herbal products). You may need to stop||
0616|175|P|taking this drug beforehand. Follow your doctor's instructions||
0616|176|P|carefully.||
0616|177|P|   If you have heart disease, this medication may mask chest||
0616|178|P|pain. Avoid strenuous exercise while taking this medication.||
0616|179|P|   If you have diabetes, tranylcypromine may lower your blood||
0616|180|P|sugar. Check your blood sugar regularly and share the results||
0616|181|P|with your doctor. Tell your doctor right away if you have||
0616|182|P|symptoms of low blood sugar such as sudden sweating, shaking,||
0616|183|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
0616|184|P|hands/feet. Your doctor may need to adjust your diabetes||
0616|185|P|medication, exercise program, or diet.||
0616|186|P|   Older adults may be more sensitive to the side effects of this||
0616|187|P|drug, especially the effects on blood pressure.||
0616|188|P|   During pregnancy, this medication should be used only when||
0616|189|P|clearly needed. Discuss the risks and benefits with your doctor.||
0616|190|P|   Since untreated mental/mood problems (such as depression) can||
0616|191|P|be a serious condition, do not stop taking this medication unless||
0616|192|P|directed by your doctor. If you are planning pregnancy, become||
0616|193|P|pregnant, or think you may be pregnant, immediately discuss with||
0616|194|P|your doctor the benefits and risks of using this medication||
0616|195|P|during pregnancy.||
0616|196|P|   This medication passes into breast milk. Consult your doctor||
0616|197|P|before breastfeeding.||
0616|198|B|||
0616|199|I|DRUG INTERACTIONS:  See also How to Use section.||
0616|200|I|   Drug interactions may change how your medications work or||
0616|201|I|increase your risk for serious side effects. This document does||
0616|202|I|not contain all possible drug interactions. Keep a list of all||
0616|203|I|the products you use (including prescription/nonprescription||
0616|204|I|drugs and herbal products) and share it with your doctor and||
0616|205|I|pharmacist. Do not start, stop, or change the dosage of any||
0616|206|I|medicines without your doctor's approval.||
0616|207|I|   Some products that may interact with this drug include: other||
0616|208|I|antidepressants (including maprotiline, mirtazapine, nefazodone,||
0616|209|I|TCAs such as amitriptyline/nortriptyline), appetite suppressants||
0616|210|I|(such as diethylpropion), drugs for attention deficit disorder||
0616|211|I|(such as atomoxetine, methylphenidate), apraclonidine, bupropion,||
0616|212|I|buspirone, carbamazepine, cyclobenzaprine, deutetrabenazine,||
0616|213|I|dextromethorphan, certain drugs for high blood pressure (such as||
0616|214|I|guanethidine, methyldopa, beta blockers such as atenolol,||
0616|215|I|clonidine, rauwolfia alkaloids), other MAO inhibitors||
0616|216|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0616|217|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0616|218|I|selegiline), certain opioid medications (such as fentanyl,||
0616|219|I|methadone, tapentadol), metoclopramide, certain drugs for||
0616|220|I|Parkinson's (such as entacapone, levodopa, tolcapone),||
0616|221|I|s-adenosyl-L-methionine (SAM-e), street drugs (such as LSD,||
0616|222|I|mescaline), tetrabenazine, "triptan" migraine drugs (such as||
0616|223|I|sumatriptan, rizatriptan), tramadol, tyrosine, tryptophan,||
0616|224|I|valbenazine.||
0616|225|I|   The risk of serotonin syndrome/toxicity increases if you are||
0616|226|I|also taking other drugs that increase serotonin. Examples include||
0616|227|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
0616|228|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0616|229|I|SNRIs such as duloxetine/venlafaxine), meperidine, among others.||
0616|230|I|The risk of serotonin syndrome/toxicity may be more likely when||
0616|231|I|you start or increase the dose of these drugs.||
0616|232|I|   Tell your doctor or pharmacist if you are using any of these||
0616|233|I|medications before, during, or within 2 weeks after treatment||
0616|234|I|with tranylcypromine. Tell your doctor or pharmacist if you have||
0616|235|I|taken fluoxetine during at least 5 weeks before starting||
0616|236|I|tranylcypromine. Discuss with your doctor how much time to wait||
0616|237|I|between starting or stopping any of these drugs and taking||
0616|238|I|tranylcypromine.||
0616|239|I|   Before using tranylcypromine, report the use of drugs that may||
0616|240|I|increase the risk of extremely high blood pressure (hypertensive||
0616|241|I|crisis) when combined with tranylcypromine, including herbal||
0616|242|I|products (such as ephedra/ma huang), nasal decongestants (such as||
0616|243|I|phenylephrine, pseudoephedrine), and stimulants (such as||
0616|244|I|amphetamines, ephedrine, epinephrine, phenylalanine).||
0616|245|I|Tranylcypromine should not be used with any of these medications.||
0616|246|I|Talk to your doctor or pharmacist for more details.||
0616|247|I|   Tell your doctor or pharmacist if you are taking other||
0616|248|I|products that cause drowsiness such as opioid pain or cough||
0616|249|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0616|250|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0616|251|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0616|252|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0616|253|I|diphenhydramine).||
0616|254|I|   Check the labels on all your medicines (such as allergy,||
0616|255|I|cough-and-cold products, diet pills) because they may contain||
0616|256|I|dextromethorphan, decongestants, stimulants, or ingredients that||
0616|257|I|cause drowsiness. Ask your pharmacist about the safe use of those||
0616|258|I|products.||
0616|259|B|||
0616|260|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0616|261|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0616|262|O|poison control center right away. US residents can call||
0616|263|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0616|264|B|||
0616|265|N|NOTES:  Do not share this medication with others.||
0616|266|N|   Lab and/or medical tests (such as blood pressure, liver||
0616|267|N|function) should be done while you are taking this medication.||
0616|268|N|Keep all medical and lab appointments. Consult your doctor for||
0616|269|N|more details.||
0616|270|B|||
0616|271|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0616|272|D|remember. If it is within 2 hours of the next dose, skip the||
0616|273|D|missed dose. Take your next dose at the regular time. Do not||
0616|274|D|double the dose to catch up.||
0616|275|B|||
0616|276|R|STORAGE:  Store at room temperature away from light and moisture.||
0616|277|R|Do not store in the bathroom. Keep all medications away from||
0616|278|R|children and pets.||
0616|279|R|   Do not flush medications down the toilet or pour them into a||
0616|280|R|drain unless instructed to do so. Properly discard this product||
0616|281|R|when it is expired or no longer needed. Consult your pharmacist||
0616|282|R|or local waste disposal company.||
0616|283|B|||
0616|284|M|MEDICAL ALERT:  Your condition can cause complications in a||
0616|285|M|medical emergency. For information about enrolling in MedicAlert,||
0616|286|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0616|287|B|||
0616|288|A|Information last revised November 2025.||
0616|289|A|Copyright(c) 2025 First Databank, Inc.||
0616|290|B|||
0617|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0617|002|Z|does NOT have all possible information about this product. This||
0617|003|Z|information does not assure that this product is safe, effective,||
0617|004|Z|or appropriate for you. This information is not individual||
0617|005|Z|medical advice and does not substitute for the advice of your||
0617|006|Z|health care professional. Always ask your health care||
0617|007|Z|professional for complete information about this product and your||
0617|008|Z|specific health needs.||
0617|009|B|||
0617|010|T|INSULIN REGULAR HUMAN - INJECTION||
0617|011|F|(IN-su-lin)||
0617|012|B|||
0617|013|C|COMMON BRAND NAME(S): Humulin R, Novolin R||
0617|014|B|||
0617|015|U|USES:  Insulin regular is used with a proper diet and exercise||
0617|016|U|program to control high blood sugar in people with diabetes.||
0617|017|U|Controlling high blood sugar helps prevent kidney damage,||
0617|018|U|blindness, nerve problems, loss of limbs, and sexual function||
0617|019|U|problems. Proper control of diabetes may also lessen your risk of||
0617|020|U|a heart attack or stroke.||
0617|021|U|   This man-made insulin product is the same as human insulin. It||
0617|022|U|replaces the insulin that your body would normally make. It is a||
0617|023|U|short-acting insulin. It works by helping blood sugar (glucose)||
0617|024|U|get into cells so your body can use it for energy. This||
0617|025|U|medication is usually used in combination with a medium- or||
0617|026|U|long-acting insulin product. This medication may also be used||
0617|027|U|alone or with other oral diabetes drugs (such as metformin).||
0617|028|B|||
0617|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0617|030|H|from your pharmacist before you start using this medication and||
0617|031|H|each time you get a refill. Ask your health care professional how||
0617|032|H|to prepare and use this medication. If you have any questions,||
0617|033|H|ask your doctor or pharmacist.||
0617|034|H|   Inject this medication under the skin as directed by your||
0617|035|H|doctor, usually 30 minutes before meals. Because this insulin is||
0617|036|H|fast-acting, not eating right after a dose of this insulin may||
0617|037|H|lead to low blood sugar (hypoglycemia). The injection is given in||
0617|038|H|the stomach area, the thigh, the buttocks, or the back of the||
0617|039|H|upper arm. Do not inject into a vein or muscle because very low||
0617|040|H|blood sugar may occur.||
0617|041|H|   The dosage is based on your medical condition and response to||
0617|042|H|treatment. Measure each dose very carefully because even small||
0617|043|H|changes in the amount of insulin may have a large effect on your||
0617|044|H|blood sugar.||
0617|045|H|   Before using, check this product for particles or||
0617|046|H|discoloration. If either is present, do not use the insulin.||
0617|047|H|Before injecting each dose, clean the skin you are going to||
0617|048|H|inject into (the injection site) with rubbing alcohol. Change the||
0617|049|H|injection site each time to lessen injury under the skin (for||
0617|050|H|example, pits/lumps or thickened skin). Do not inject into skin||
0617|051|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
0617|052|H|not rub the injection site after a shot. Do not inject cold||
0617|053|H|insulin because this can be painful. The insulin container you||
0617|054|H|are currently using can be kept at room temperature. Learn how to||
0617|055|H|store and discard medical supplies safely.||
0617|056|H|   Giving insulin regular into a vein should only be done by a||
0617|057|H|health care professional. Very low blood sugar may result.||
0617|058|H|   Do not use insulin regular in an insulin pump.||
0617|059|H|   This product may be mixed only with certain other insulin||
0617|060|H|products such as NPH insulin. Always draw the insulin regular||
0617|061|H|into the syringe first, then follow with the longer-acting||
0617|062|H|insulin. Never inject a mixture of different insulins into a||
0617|063|H|vein. Consult your health care professional about which products||
0617|064|H|may be mixed, the proper method for mixing insulin, and the||
0617|065|H|proper way to inject mixtures of insulin.||
0617|066|H|   Do not change brands or types of insulin without directions on||
0617|067|H|how to do so from your doctor.||
0617|068|H|   Do not share your pen device with another person, even if the||
0617|069|H|needle is changed. You may give other people a serious infection,||
0617|070|H|or get a serious infection from them.||
0617|071|H|   Use this medication regularly to get the most benefit from it.||
0617|072|H|To help you remember, use it at the same times each day.||
0617|073|H|   Tell your doctor if your condition does not get better or if||
0617|074|H|it gets worse (your blood sugar is too high or too low).||
0617|075|B|||
0617|076|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
0617|077|S|irritation) or weight gain may occur. If any of these effects||
0617|078|S|last or get worse, tell your doctor or pharmacist promptly.||
0617|079|S|   Remember that this medication has been prescribed because your||
0617|080|S|doctor has judged that the benefit to you is greater than the||
0617|081|S|risk of side effects. Many people using this medication do not||
0617|082|S|have serious side effects.||
0617|083|S|   Tell your doctor right away if you have any serious side||
0617|084|S|effects, including: signs of low potassium level in the blood||
0617|085|S|(such as muscle cramps, weakness, irregular heartbeat).||
0617|086|S|   This medication can cause low blood sugar (hypoglycemia). This||
0617|087|S|may occur if you do not get enough calories from food or if you||
0617|088|S|do unusually heavy exercise. Symptoms of low blood sugar include||
0617|089|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
0617|090|S|dizziness, or tingling hands/feet. It is a good habit to carry||
0617|091|S|glucose tablets or gel to treat low blood sugar. If you don't||
0617|092|S|have these reliable forms of glucose, rapidly raise your blood||
0617|093|S|sugar by eating a quick source of sugar such as table sugar,||
0617|094|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
0617|095|S|doctor right away about the reaction and the use of this product.||
0617|096|S|To help prevent low blood sugar, eat meals on a regular schedule,||
0617|097|S|and do not skip meals. Check with your doctor or pharmacist to||
0617|098|S|find out what you should do if you miss a meal.||
0617|099|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0617|100|S|thirst/urination. If these symptoms occur, tell your doctor right||
0617|101|S|away. Your doctor may need to adjust your diabetes medication,||
0617|102|S|exercise program, or diet.||
0617|103|S|   A very serious allergic reaction to this drug is rare.||
0617|104|S|However, get medical help right away if you notice any symptoms||
0617|105|S|of a serious allergic reaction, including: rash, itching/swelling||
0617|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0617|107|S|breathing.||
0617|108|S|   This is not a complete list of possible side effects. If you||
0617|109|S|notice other effects not listed above, contact your doctor or||
0617|110|S|pharmacist.||
0617|111|S|   In the US -||
0617|112|S|   Call your doctor for medical advice about side effects. You||
0617|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0617|114|S|www.fda.gov/medwatch.||
0617|115|S|   In Canada - Call your doctor for medical advice about side||
0617|116|S|effects. You may report side effects to Health Canada at||
0617|117|S|1-866-234-2345.||
0617|118|B|||
0617|119|P|PRECAUTIONS:  Before using insulin regular, tell your doctor or||
0617|120|P|pharmacist if you are allergic to it; or to other insulins; or if||
0617|121|P|you have any other allergies. This product may contain inactive||
0617|122|P|ingredients, which can cause allergic reactions or other||
0617|123|P|problems. Talk to your pharmacist for more details.||
0617|124|P|   Do not use this medication when you have low blood sugar||
0617|125|P|(hypoglycemia).||
0617|126|P|   Before using this medication, tell your doctor or pharmacist||
0617|127|P|your medical history, especially of: kidney disease, liver||
0617|128|P|disease, thyroid problems.||
0617|129|P|   You may experience blurred vision, dizziness, or drowsiness||
0617|130|P|due to extremely low or high blood sugar. Do not drive, use||
0617|131|P|machinery, or do anything that needs alertness or clear vision||
0617|132|P|until you can do it safely.||
0617|133|P|   Limit alcohol while taking this medication because it can||
0617|134|P|increase your risk of developing low blood sugar.||
0617|135|P|   It may be harder to control your blood sugar when your body is||
0617|136|P|stressed (such as due to fever, infection, injury, or surgery).||
0617|137|P|Consult your doctor because this may require a change in your||
0617|138|P|treatment plan, medications, or blood sugar testing.||
0617|139|P|   Before having surgery, tell your doctor or dentist about all||
0617|140|P|the products you use (including prescription drugs,||
0617|141|P|nonprescription drugs, and herbal products).||
0617|142|P|   Check your blood sugar before and after exercise. You may need||
0617|143|P|a snack before exercising.||
0617|144|P|   If traveling across time zones, ask your doctor about how to||
0617|145|P|adjust your insulin schedule. Take extra insulin and supplies||
0617|146|P|with you.||
0617|147|P|   Older adults may be more sensitive to the side effects of this||
0617|148|P|drug, especially low blood sugar.||
0617|149|P|   Children may be more sensitive to the side effects of this||
0617|150|P|drug, especially low blood sugar.||
0617|151|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
0617|152|P|cause or worsen diabetes. Discuss a plan with your doctor for||
0617|153|P|managing your blood sugar while pregnant. Your doctor may change||
0617|154|P|your diabetes treatment during your pregnancy (such as diet and||
0617|155|P|medications including insulin).||
0617|156|P|   This medication passes into breast milk, but is unlikely to||
0617|157|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0617|158|P|Your insulin needs may change while breastfeeding.||
0617|159|B|||
0617|160|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0617|161|I|medications work or increase your risk for serious side effects.||
0617|162|I|This document does not contain all possible drug interactions.||
0617|163|I|Keep a list of all the products you use (including||
0617|164|I|prescription/nonprescription drugs and herbal products) and share||
0617|165|I|it with your doctor and pharmacist. Do not start, stop, or change||
0617|166|I|the dosage of any medicines without your doctor's approval.||
0617|167|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0617|168|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0617|169|I|heartbeat you would usually feel when your blood sugar falls too||
0617|170|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0617|171|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0617|172|I|   Many drugs can affect your blood sugar levels, making it more||
0617|173|I|difficult to control your blood sugar. Before you start, stop, or||
0617|174|I|change any medication, talk with your doctor or pharmacist about||
0617|175|I|how the medication may affect your blood sugar. Check your blood||
0617|176|I|sugar regularly as directed by your doctor. Tell your doctor||
0617|177|I|about the results and of any symptoms of high or low blood sugar.||
0617|178|I|(See also Side Effects section.) Your doctor may need to adjust||
0617|179|I|your diabetes medication, exercise program, or diet.||
0617|180|B|||
0617|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0617|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0617|183|O|poison control center right away. US residents can call||
0617|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0617|185|O|Symptoms of overdose may include: signs of low blood sugar such||
0617|186|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
0617|187|B|||
0617|188|N|NOTES:  Do not share this medication, needles, or syringes with||
0617|189|N|others.||
0617|190|N|   Attend a diabetes education program to learn more about how to||
0617|191|N|manage your diabetes with medications, diet, exercise, and||
0617|192|N|regular medical exams.||
0617|193|N|   Learn the symptoms of high and low blood sugar and how to||
0617|194|N|treat low blood sugar. Check your blood sugar regularly as||
0617|195|N|directed and share the results with your doctor.||
0617|196|N|   Lab and/or medical tests (such as liver/kidney function,||
0617|197|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
0617|198|N|should be done while you are taking this medication. Keep all||
0617|199|N|medical and lab appointments.||
0617|200|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
0617|201|B|||
0617|202|D|MISSED DOSE:  It is very important to follow your insulin regimen||
0617|203|D|exactly. Ask your doctor ahead of time what you should do if you||
0617|204|D|miss a dose of insulin.||
0617|205|B|||
0617|206|R|STORAGE:  Different brands of this medication have different||
0617|207|R|storage needs. Check the product package for instructions on how||
0617|208|R|to store your brand, or ask your pharmacist. Protect insulin from||
0617|209|R|light and heat. Do not store in the bathroom. Do not freeze, and||
0617|210|R|do not use insulin that has been frozen. Throw away all insulin||
0617|211|R|products after the expiration date on the package, or after the||
0617|212|R|specified number of days after it has been opened or kept at room||
0617|213|R|temperature, whichever date is earlier. Keep all medications away||
0617|214|R|from children and pets.||
0617|215|R|   Do not flush medications down the toilet or pour them into a||
0617|216|R|drain unless instructed to do so. Properly discard this product||
0617|217|R|when it is expired or no longer needed. Consult your pharmacist||
0617|218|R|or local waste disposal company.||
0617|219|B|||
0617|220|M|MEDICAL ALERT:  Your condition can cause complications in a||
0617|221|M|medical emergency. For information about enrolling in MedicAlert,||
0617|222|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0617|223|B|||
0617|224|A|Information last revised April 2025.||
0617|225|A|Copyright(c) 2025 First Databank, Inc.||
0617|226|B|||
0618|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0618|002|Z|does NOT have all possible information about this product. This||
0618|003|Z|information does not assure that this product is safe, effective,||
0618|004|Z|or appropriate for you. This information is not individual||
0618|005|Z|medical advice and does not substitute for the advice of your||
0618|006|Z|health care professional. Always ask your health care||
0618|007|Z|professional for complete information about this product and your||
0618|008|Z|specific health needs.||
0618|009|B|||
0618|010|T|SUNITINIB - ORAL||
0618|011|F|(soo-NI-ti-nib)||
0618|012|B|||
0618|013|C|COMMON BRAND NAME(S): Sutent||
0618|014|B|||
0618|015|W|WARNING:  Rarely, sunitinib has caused severe (sometimes fatal)||
0618|016|W|liver problems. Get medical help right away if you develop||
0618|017|W|symptoms of liver problems such as nausea/vomiting that doesn't||
0618|018|W|stop, severe stomach/abdominal pain, dark urine, pale stools, or||
0618|019|W|yellowing eyes/skin. Your doctor will monitor for liver problems||
0618|020|W|with blood tests. Tell all of your doctors and pharmacists if you||
0618|021|W|have ever stopped taking sunitinib because of liver problems||
0618|022|W|(including high liver enzymes).||
0618|023|B|||
0618|024|U|USES:  This medication is used to treat certain types of cancer||
0618|025|U|(kidney, pancreas, and intestinal). It is also used to treat||
0618|026|U|people who are at high risk of the kidney cancer coming back||
0618|027|U|again after having kidney surgery. Sunitinib works by stopping or||
0618|028|U|slowing the growth of cancer tumors. It also works by slowing the||
0618|029|U|growth of new blood vessels within the tumor.||
0618|030|B|||
0618|031|H|HOW TO USE:  Read the Medication Guide provided by your||
0618|032|H|pharmacist before you start taking sunitinib and each time you||
0618|033|H|get a refill. If you have any questions, ask your doctor or||
0618|034|H|pharmacist.||
0618|035|H|   Take this medication by mouth with or without food as directed||
0618|036|H|by your doctor, usually once daily. For some conditions, you may||
0618|037|H|be directed to take this medication for a specific period of time||
0618|038|H|followed by another period of time off of the drug. For other||
0618|039|H|conditions, you may be directed to take sunitinib every day||
0618|040|H|without a break. Follow your doctor's instructions carefully.||
0618|041|H|   Drink plenty of fluids during treatment with this medication,||
0618|042|H|unless otherwise directed by your doctor.||
0618|043|H|   The dosage is based on your medical condition, response to||
0618|044|H|treatment, and other medications you may be taking. Be sure to||
0618|045|H|tell your doctor and pharmacist about all the products you use||
0618|046|H|(including prescription drugs, nonprescription drugs, and herbal||
0618|047|H|products).||
0618|048|H|   Do not increase your dose or take this medication more often||
0618|049|H|without your doctor's approval. Your condition will not improve||
0618|050|H|any faster, and the risk of serious side effects may be||
0618|051|H|increased.||
0618|052|H|   Use this medication regularly in order to get the most benefit||
0618|053|H|from it. To help you remember, take it at the same time each day.||
0618|054|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0618|055|H|using this medication unless your doctor or pharmacist says you||
0618|056|H|may do so safely. Grapefruit can increase the chance of side||
0618|057|H|effects with this medicine. Ask your doctor or pharmacist for||
0618|058|H|more details.||
0618|059|B|||
0618|060|S|SIDE EFFECTS:  See also Warning section.||
0618|061|S|   Upset stomach, nausea, vomiting, diarrhea, change in taste,||
0618|062|S|decreased appetite, dry/cracked/thickened skin, watering eyes,||
0618|063|S|swelling around eyes, numbness/tingling of arms/legs, or||
0618|064|S|tiredness may occur. In some cases, drug therapy may be necessary||
0618|065|S|to prevent or relieve nausea/vomiting/diarrhea. Eating several||
0618|066|S|small meals or limiting activity may help lessen some of these||
0618|067|S|effects. If these effects last or get worse, notify your doctor||
0618|068|S|or pharmacist promptly.||
0618|069|S|   This medication may cause patchy or complete hair loss and||
0618|070|S|changes in hair/skin color. These effects are not harmful.||
0618|071|S|However, talk to your doctor for more details since changes in||
0618|072|S|skin color may also be a sign of a more serious condition.||
0618|073|S|   Remember that this medication has been prescribed because your||
0618|074|S|doctor has judged that the benefit to you is greater than the||
0618|075|S|risk of side effects. Many people using this medication do not||
0618|076|S|have serious side effects.||
0618|077|S|   Tell your doctor right away if you have any serious side||
0618|078|S|effects, including: headache, rash/blisters on palms of||
0618|079|S|hands/soles of feet, sores/pain on the tongue/mouth, easy||
0618|080|S|bruising/bleeding, cold/heat intolerance, pain/redness/swelling||
0618|081|S|of arms or legs, black/bloody stools, vomit that looks like||
0618|082|S|coffee grounds, coughing up blood, slow wound healing, jaw pain,||
0618|083|S|toe/joint pain, signs of low blood sugar (such as hunger,||
0618|084|S|shakiness, fast heartbeat, sweating), symptoms of heart failure||
0618|085|S|(such as shortness of breath, swelling ankles/feet, unusual||
0618|086|S|tiredness, unusual/sudden weight gain), mental/mood changes (such||
0618|087|S|as decreased alertness, irritability, nervousness), vision||
0618|088|S|changes (such as decreased vision).||
0618|089|S|   This medication may raise your blood pressure. Check your||
0618|090|S|blood pressure regularly and tell your doctor if the results are||
0618|091|S|high. Your doctor may control your blood pressure with||
0618|092|S|medication.||
0618|093|S|   Sunitinib sometimes causes side effects due to the rapid||
0618|094|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
0618|095|S|risk, your doctor may add a medication and tell you to drink||
0618|096|S|plenty of fluids. Tell your doctor right away if you have||
0618|097|S|symptoms such as: signs of kidney problems (such as painful||
0618|098|S|urination, cloudy/pink/bloody urine, change in the amount of||
0618|099|S|urine), muscle spasms/weakness.||
0618|100|S|   Get medical help right away if you have any very serious side||
0618|101|S|effects, including: trouble breathing, chest/jaw/left arm pain,||
0618|102|S|sudden/severe back pain, weakness on one side of the body,||
0618|103|S|trouble speaking, severe dizziness, fainting, fast/slow/irregular||
0618|104|S|heartbeat, seizures.||
0618|105|S|   Sunitinib has rarely caused very serious (possibly fatal) skin||
0618|106|S|reactions. Get medical help right away if you develop symptoms of||
0618|107|S|serious skin reactions, including: rash,||
0618|108|S|hot/peeling/blistering/painful skin, red/purple skin.||
0618|109|S|   This medication may lower your ability to fight infections.||
0618|110|S|This may make you more likely to get a serious (rarely fatal)||
0618|111|S|infection or make any infection you have worse. Tell your doctor||
0618|112|S|right away if you have any signs of infection (such as sore||
0618|113|S|throat that doesn't go away, fever, chills).||
0618|114|S|   A very serious allergic reaction to this drug is rare.||
0618|115|S|However, get medical help right away if you notice any symptoms||
0618|116|S|of a serious allergic reaction, including: rash, itching/swelling||
0618|117|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0618|118|S|breathing.||
0618|119|S|   This is not a complete list of possible side effects. If you||
0618|120|S|notice other effects not listed above, contact your doctor or||
0618|121|S|pharmacist.||
0618|122|S|   In the US -||
0618|123|S|   Call your doctor for medical advice about side effects. You||
0618|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0618|125|S|www.fda.gov/medwatch.||
0618|126|S|   In Canada - Call your doctor for medical advice about side||
0618|127|S|effects. You may report side effects to Health Canada at||
0618|128|S|1-866-234-2345.||
0618|129|B|||
0618|130|P|PRECAUTIONS:  Before taking sunitinib, tell your doctor or||
0618|131|P|pharmacist if you are allergic to it; or if you have any other||
0618|132|P|allergies. This product may contain inactive ingredients, which||
0618|133|P|can cause allergic reactions or other problems. Talk to your||
0618|134|P|pharmacist for more details.||
0618|135|P|   Before using this medication, tell your doctor or pharmacist||
0618|136|P|your medical history, especially of: bleeding problems, heart||
0618|137|P|problems (such as heart attack), high blood pressure, liver||
0618|138|P|problems, kidney disease, thyroid disease, diabetes, blood vessel||
0618|139|P|problems (such as an aneurysm or a tear/break in the aorta or||
0618|140|P|other blood vessels).||
0618|141|P|   Sunitinib may cause a condition that affects the heart rhythm||
0618|142|P|(QT prolongation). QT prolongation can rarely cause serious||
0618|143|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0618|144|P|as severe dizziness, fainting) that need medical attention right||
0618|145|P|away.||
0618|146|P|   The risk of QT prolongation may be increased if you have||
0618|147|P|certain medical conditions or are taking other drugs that may||
0618|148|P|cause QT prolongation. Before using sunitinib, tell your doctor||
0618|149|P|or pharmacist of all the drugs you take and if you have any of||
0618|150|P|the following conditions: certain heart problems (heart failure,||
0618|151|P|slow heartbeat, QT prolongation in the EKG), family history of||
0618|152|P|certain heart problems (QT prolongation in the EKG, sudden||
0618|153|P|cardiac death).||
0618|154|P|   Low levels of potassium or magnesium in the blood may also||
0618|155|P|increase your risk of QT prolongation. This risk may increase if||
0618|156|P|you use certain drugs (such as diuretics/"water pills") or if you||
0618|157|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0618|158|P|Talk to your doctor about using sunitinib safely.||
0618|159|P|   Do not have immunizations/vaccinations without the consent of||
0618|160|P|your doctor, and avoid contact with people who have recently||
0618|161|P|received oral polio vaccine or flu vaccine inhaled through the||
0618|162|P|nose.||
0618|163|P|   To lower the chance of getting cut, bruised or injured, use||
0618|164|P|caution with sharp objects like safety razors or nail cutters and||
0618|165|P|avoid activities such as contact sports.||
0618|166|P|   Wash your hands well to prevent the spread of infections.||
0618|167|P|   Some people taking sunitinib may have serious jawbone||
0618|168|P|problems. Your doctor should check your mouth before you start||
0618|169|P|this medication. Tell your dentist that you are taking this||
0618|170|P|medication before you have any dental work done. To help prevent||
0618|171|P|jawbone problems, have regular dental exams and learn how to keep||
0618|172|P|your teeth and gums healthy. If you have jaw pain, tell your||
0618|173|P|doctor and dentist right away.||
0618|174|P|   Before having surgery (including dental procedures), tell your||
0618|175|P|doctor or dentist about this medication and all the products you||
0618|176|P|use (including prescription drugs, nonprescription drugs, and||
0618|177|P|herbal products).||
0618|178|P|   This medication may cause wounds to heal slowly or poorly.||
0618|179|P|Your doctor or dentist may tell you to temporarily stop treatment||
0618|180|P|with this medication at least 3 weeks before surgery or a dental||
0618|181|P|procedure. Ask your doctor or dentist for specific instructions||
0618|182|P|about when to stop and when to restart treatment with this||
0618|183|P|medication. Tell your doctor/dentist right away if you have||
0618|184|P|wounds that are not healing well.||
0618|185|P|   Older adults may be more sensitive to the side effects of this||
0618|186|P|drug, especially QT prolongation (see above).||
0618|187|P|   Tell your doctor if you are pregnant or plan to become||
0618|188|P|pregnant. You should not become pregnant while using sunitinib.||
0618|189|P|Sunitinib may harm an unborn baby. Your doctor should order a||
0618|190|P|pregnancy test before you start this medication. Women using this||
0618|191|P|medication should ask about reliable forms of birth control||
0618|192|P|during treatment and for 4 weeks after the last dose. Men using||
0618|193|P|this medication should ask about reliable forms of birth control||
0618|194|P|during treatment and for 7 weeks after the last dose. If you or||
0618|195|P|your partner becomes pregnant, talk to your doctor right away||
0618|196|P|about the risks and benefits of this medication.||
0618|197|P|   It is unknown if this drug passes into breast milk. Because of||
0618|198|P|the possible risk to the infant, breastfeeding is not recommended||
0618|199|P|while using this drug and for 4 weeks after the last dose.||
0618|200|P|Consult your doctor before breastfeeding.||
0618|201|B|||
0618|202|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0618|203|I|medications work or increase your risk for serious side effects.||
0618|204|I|This document does not contain all possible drug interactions.||
0618|205|I|Keep a list of all the products you use (including||
0618|206|I|prescription/nonprescription drugs and herbal products) and share||
0618|207|I|it with your doctor and pharmacist. Do not start, stop, or change||
0618|208|I|the dosage of any medicines without your doctor's approval.||
0618|209|I|   Some products that may interact with this drug include:||
0618|210|I|bevacizumab, "blood thinners" (anticoagulants such as warfarin,||
0618|211|I|heparins).||
0618|212|I|   Many drugs besides sunitinib may affect the heart rhythm (QT||
0618|213|I|prolongation), including amiodarone, dofetilide, pimozide,||
0618|214|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
0618|215|I|erythromycin), among others. Before using sunitinib, report all||
0618|216|I|medications you are currently using to your doctor or pharmacist.||
0618|217|I|   Other medications can affect the removal of sunitinib from||
0618|218|I|your body, which may affect how sunitinib works. Examples include||
0618|219|I|azole antifungals (such as ketoconazole, itraconazole),||
0618|220|I|cimetidine, macrolide antibiotics (such as erythromycin),||
0618|221|I|ritonavir, St. John's wort, certain drugs used to treat seizures||
0618|222|I|(such as phenytoin, phenobarbital), among others.||
0618|223|B|||
0618|224|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0618|225|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0618|226|O|poison control center right away. US residents can call||
0618|227|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0618|228|B|||
0618|229|N|NOTES:  Do not share this medication with others.||
0618|230|N|   Lab and/or medical tests (such as blood pressure, complete||
0618|231|N|blood count, heart/liver/kidney/thyroid function, blood sugar,||
0618|232|N|uric acid level, pancreatic enzymes, urine protein levels, blood||
0618|233|N|mineral levels such as sodium, potassium, phosphate) should be||
0618|234|N|done while you are taking this medication. Keep all medical and||
0618|235|N|lab appointments. Consult your doctor for more details.||
0618|236|B|||
0618|237|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0618|238|D|remember. If it is less than 12 hours before the next dose, skip||
0618|239|D|the missed dose. Take your next dose at the regular time. Do not||
0618|240|D|double the dose to catch up.||
0618|241|B|||
0618|242|R|STORAGE:  Store at room temperature away from light and moisture.||
0618|243|R|Do not store in the bathroom. Keep all medications away from||
0618|244|R|children and pets.||
0618|245|R|   Do not flush medications down the toilet or pour them into a||
0618|246|R|drain unless instructed to do so. Properly discard this product||
0618|247|R|when it is expired or no longer needed. Consult your pharmacist||
0618|248|R|or local waste disposal company.||
0618|249|B|||
0618|250|M|MEDICAL ALERT:  Your condition can cause complications in a||
0618|251|M|medical emergency. For information about enrolling in MedicAlert,||
0618|252|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0618|253|B|||
0618|254|A|Information last revised April 2025.||
0618|255|A|Copyright(c) 2025 First Databank, Inc.||
0618|256|B|||
0619|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0619|002|Z|does NOT have all possible information about this product. This||
0619|003|Z|information does not assure that this product is safe, effective,||
0619|004|Z|or appropriate for you. This information is not individual||
0619|005|Z|medical advice and does not substitute for the advice of your||
0619|006|Z|health care professional. Always ask your health care||
0619|007|Z|professional for complete information about this product and your||
0619|008|Z|specific health needs.||
0619|009|B|||
0619|010|T|IBANDRONATE - INJECTION||
0619|011|F|(eye-BAN-droe-nate)||
0619|012|B|||
0619|013|C|COMMON BRAND NAME(S): Boniva||
0619|014|B|||
0619|015|U|USES:  Ibandronate is used to prevent and treat certain types of||
0619|016|U|bone loss (osteoporosis). Osteoporosis causes bones to become||
0619|017|U|thinner and break more easily. Your chance of developing||
0619|018|U|osteoporosis increases after menopause, as you age, or if you||
0619|019|U|take corticosteroid medications (such as prednisone) for long||
0619|020|U|periods.||
0619|021|U|   This medication works by slowing bone loss to help maintain||
0619|022|U|strong bones and reduce the risk of broken bones (fractures).||
0619|023|U|Ibandronate belongs to a class of medications called||
0619|024|U|bisphosphonates.||
0619|025|B|||
0619|026|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0619|027|H|Patient Information Leaflet provided by your pharmacist before||
0619|028|H|you start using ibandronate and each time you get another dose.||
0619|029|H|If you have any questions, ask your doctor or pharmacist.||
0619|030|H|   This medication is given by injection into a vein over a||
0619|031|H|period of 15-30 seconds by a health care professional as directed||
0619|032|H|by your doctor. It is usually given once every 3 months.||
0619|033|H|   Use this medication regularly to get the most benefit from it.||
0619|034|H|To help you remember, mark your calendar with a reminder. Keep||
0619|035|H|receiving this medication even if you feel well. Most people with||
0619|036|H|osteoporosis do not have symptoms. Talk to your doctor about the||
0619|037|H|risks and benefits of long-term use of this medication.||
0619|038|H|   Continue to take other medications for your condition as||
0619|039|H|directed by your doctor.||
0619|040|B|||
0619|041|S|SIDE EFFECTS:  Headache, flu-like symptoms (such as fever,||
0619|042|S|chills, tiredness, joint/muscle ache), or injection site||
0619|043|S|reactions (such as redness, swelling) may occur. If any of these||
0619|044|S|effects last or get worse, tell your doctor or pharmacist||
0619|045|S|promptly.||
0619|046|S|   Remember that this medication has been prescribed because your||
0619|047|S|doctor has judged that the benefit to you is greater than the||
0619|048|S|risk of side effects. Many people using this medication do not||
0619|049|S|have serious side effects.||
0619|050|S|   Tell your doctor right away if you have any serious side||
0619|051|S|effects, including: increased or severe bone/joint/muscle pain,||
0619|052|S|new or unusual hip/thigh/groin pain, jaw pain, vision changes,||
0619|053|S|signs of kidney problems (such as change in the amount of urine).||
0619|054|S|   A very serious allergic reaction to this drug is rare.||
0619|055|S|However, get medical help right away if you notice any symptoms||
0619|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0619|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0619|058|S|breathing.||
0619|059|S|   This is not a complete list of possible side effects. If you||
0619|060|S|notice other effects not listed above, contact your doctor or||
0619|061|S|pharmacist.||
0619|062|S|   In the US -||
0619|063|S|   Call your doctor for medical advice about side effects. You||
0619|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0619|065|S|www.fda.gov/medwatch.||
0619|066|S|   In Canada - Call your doctor for medical advice about side||
0619|067|S|effects. You may report side effects to Health Canada at||
0619|068|S|1-866-234-2345.||
0619|069|B|||
0619|070|P|PRECAUTIONS:  Before using ibandronate, tell your doctor or||
0619|071|P|pharmacist if you are allergic to it; or to other bisphosphonates||
0619|072|P|(such as alendronate, etidronate, pamidronate, risedronate); or||
0619|073|P|if you have any other allergies. This product may contain||
0619|074|P|inactive ingredients, which can cause allergic reactions or other||
0619|075|P|problems. Talk to your pharmacist for more details.||
0619|076|P|   Before using this medication, tell your doctor or pharmacist||
0619|077|P|your medical history, especially of: low blood calcium levels||
0619|078|P|(hypocalcemia), severe kidney disease.||
0619|079|P|   Some people using ibandronate may have serious jawbone||
0619|080|P|problems. Your doctor should check your mouth before you start||
0619|081|P|this medication. Tell your dentist that you are using this||
0619|082|P|medication before you have any dental work done. To help prevent||
0619|083|P|jawbone problems, have regular dental exams and learn how to keep||
0619|084|P|your teeth and gums healthy. If you have jaw pain, tell your||
0619|085|P|doctor and dentist right away.||
0619|086|P|   Before having surgery (especially dental procedures), tell||
0619|087|P|your doctor and dentist about all the products you use (including||
0619|088|P|prescription drugs, nonprescription drugs, and herbal products).||
0619|089|P|Your doctor or dentist may tell you to stop taking ibandronate||
0619|090|P|before your surgery. Ask for specific instructions about stopping||
0619|091|P|or starting this medication.||
0619|092|P|   Tell your doctor if you are pregnant or plan to become||
0619|093|P|pregnant. Ibandronate may stay in your body for many years. You||
0619|094|P|should not become pregnant while using ibandronate. Discuss the||
0619|095|P|risks and benefits with your doctor.||
0619|096|P|   It is unknown if this drug passes into breast milk. Consult||
0619|097|P|your doctor before breastfeeding.||
0619|098|B|||
0619|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0619|100|I|medications work or increase your risk for serious side effects.||
0619|101|I|This document does not contain all possible drug interactions.||
0619|102|I|Keep a list of all the products you use (including||
0619|103|I|prescription/nonprescription drugs and herbal products) and share||
0619|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
0619|105|I|the dosage of any medicines without your doctor's approval.||
0619|106|I|   This medication may interfere with certain lab tests (such as||
0619|107|I|bone-imaging tests), possibly causing false test results. Make||
0619|108|I|sure lab personnel and all your doctors know you use this drug.||
0619|109|B|||
0619|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0619|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0619|112|O|poison control center right away. US residents can call||
0619|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0619|114|B|||
0619|115|N|NOTES:  Do not share this medication with others.||
0619|116|N|   Lifestyle changes that help promote healthy bones include||
0619|117|N|increasing weight-bearing exercise, stopping smoking, limiting||
0619|118|N|alcohol, and eating well-balanced meals that contain adequate||
0619|119|N|calcium and vitamin D. You may also need to take calcium and||
0619|120|N|vitamin D supplements and make lifestyle changes. Consult your||
0619|121|N|doctor for specific advice.||
0619|122|N|   Lab and/or medical tests (such as bone density tests, X-rays,||
0619|123|N|height, blood mineral levels, kidney function) should be done||
0619|124|N|while you are using this medication. Keep all medical and lab||
0619|125|N|appointments. Consult your doctor for more details.||
0619|126|B|||
0619|127|D|MISSED DOSE:  If you miss a dose, reschedule with your health||
0619|128|D|care professional as soon as possible. Continue every 3 months||
0619|129|D|from the date you actually receive the missed dose. If you have||
0619|130|D|any questions, ask your doctor or pharmacist.||
0619|131|B|||
0619|132|R|STORAGE:  Not applicable. This medication is given in a hospital||
0619|133|R|or clinic and will not be stored at home.||
0619|134|B|||
0619|135|A|Information last revised October 2024.||
0619|136|A|Copyright(c) 2025 First Databank, Inc.||
0619|137|B|||
0620|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0620|002|Z|does NOT have all possible information about this product. This||
0620|003|Z|information does not assure that this product is safe, effective,||
0620|004|Z|or appropriate for you. This information is not individual||
0620|005|Z|medical advice and does not substitute for the advice of your||
0620|006|Z|health care professional. Always ask your health care||
0620|007|Z|professional for complete information about this product and your||
0620|008|Z|specific health needs.||
0620|009|B|||
0620|010|T|ROTAVIRUS VACCINE - ORAL||
0620|011|F|(roe-TUH VYE-russ)||
0620|012|B|||
0620|013|C|COMMON BRAND NAME(S): Rotarix, Rotateq||
0620|014|B|||
0620|015|U|USES:  This vaccine is used to help prevent a certain virus||
0620|016|U|infection (rotavirus) in infants and young children. The||
0620|017|U|infection can cause fever, vomiting, and diarrhea, which can lead||
0620|018|U|to severe (rarely fatal) dehydration. Vaccination is the best way||
0620|019|U|to protect against this infection.||
0620|020|U|   This vaccine contains live viruses that have been weakened. It||
0620|021|U|works by increasing the body's natural defense (immunity) against||
0620|022|U|the virus.||
0620|023|U|   Vaccines may not fully protect everyone who receives them.||
0620|024|B|||
0620|025|H|HOW TO USE:  Read all vaccine information available from your||
0620|026|H|health care professional before receiving the vaccine. If you||
0620|027|H|have any questions, ask your health care professional.||
0620|028|H|   This vaccine is given by mouth by a health care professional.||
0620|029|H|   Vaccines are usually given in a series of doses to provide the||
0620|030|H|best protection. Closely follow the vaccination schedule provided||
0620|031|H|by your health care professional. To help you remember, mark your||
0620|032|H|calendar with a reminder.||
0620|033|H|   This vaccine may be given at the same time as other vaccines.||
0620|034|B|||
0620|035|S|SIDE EFFECTS:  Mild fever, diarrhea, or vomiting may occur. If||
0620|036|S|any of these effects last or get worse, tell the health care||
0620|037|S|professional promptly.||
0620|038|S|   Remember that this vaccine has been prescribed because the||
0620|039|S|health care professional has judged that the benefit to your||
0620|040|S|child is greater than the risk of side effects. Many people using||
0620|041|S|this vaccine do not have serious side effects.||
0620|042|S|   Tell the health care professional right away if your child has||
0620|043|S|any serious side effects, including: high fever (higher than 102||
0620|044|S|degrees F/39 degrees C).||
0620|045|S|   Rarely, a certain serious intestinal problem (intussusception)||
0620|046|S|has occurred in babies after receiving this vaccine.||
0620|047|S|Intussusception happens when a part of the intestine gets blocked||
0620|048|S|or twisted. The risk may be higher within 21 days after receiving||
0620|049|S|the first dose of rotavirus vaccine, especially in the first 7||
0620|050|S|days. Get medical help right away if you notice symptoms such as||
0620|051|S|bloody stools or sudden severe abdominal pain/diarrhea. In||
0620|052|S|babies, symptoms may include pulling the knees to the chest and||
0620|053|S|crying, or crying when the abdomen is touched.||
0620|054|S|   A very serious allergic reaction to this vaccine is rare.||
0620|055|S|However, get medical help right away if you notice any symptoms||
0620|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0620|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0620|058|S|breathing.||
0620|059|S|   This is not a complete list of possible side effects. If you||
0620|060|S|notice other effects not listed above, contact the health care||
0620|061|S|professional.||
0620|062|S|   Contact the health care professional for medical advice about||
0620|063|S|side effects. The following numbers do not provide medical||
0620|064|S|advice, but in the US you may report side effects to the Vaccine||
0620|065|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
0620|066|S|Canada, you may call the Vaccine Safety Section at Public Health||
0620|067|S|Agency of Canada at 1-866-844-0018.||
0620|068|B|||
0620|069|P|PRECAUTIONS:  Before your child takes this vaccine, tell the||
0620|070|P|health care professional if your child is allergic to it; or if||
0620|071|P|your child has any other allergies. This product may contain||
0620|072|P|inactive ingredients (such as latex found in the packaging of||
0620|073|P|some products), which can cause allergic reactions or other||
0620|074|P|problems. Talk to your health care professional for more details.||
0620|075|P|   Before using this vaccine, tell your health care professional||
0620|076|P|your child's medical history, especially of: current||
0620|077|P|fever/illness (including vomiting/diarrhea), stomach/intestinal||
0620|078|P|problems (such as blockage, intussusception), immune system||
0620|079|P|disorders (such as due to HIV infection, SCID, certain cancers||
0620|080|P|such as leukemia/lymphoma, cancer or radiation treatment),||
0620|081|P|vaccination history (including previous reactions to any||
0620|082|P|vaccines).||
0620|083|P|   Family or household members with cancer or weakened immune||
0620|084|P|systems may rarely become infected with this virus if they have||
0620|085|P|regular close contact with a child who takes this vaccine. People||
0620|086|P|in close contact with your child should practice good hygiene||
0620|087|P|such as washing hands thoroughly after diaper changes and||
0620|088|P|feedings. Ask the health care professional for more details.||
0620|089|P|   This vaccine is not used by adults. It is unlikely to be used||
0620|090|P|during pregnancy or breastfeeding. Consult the health care||
0620|091|P|professional if you have any questions about this vaccine.||
0620|092|B|||
0620|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0620|094|I|medications work or increase your risk for serious side effects.||
0620|095|I|This document does not contain all possible drug interactions.||
0620|096|I|Keep a list of all the products you use (including||
0620|097|I|prescription/nonprescription drugs and herbal products) and share||
0620|098|I|it with your health care professional. Do not start, stop, or||
0620|099|I|change the dosage of any medicines without your doctor's||
0620|100|I|approval.||
0620|101|I|   Some products that may interact with this vaccine are: drugs||
0620|102|I|that weaken the immune system (such as cyclosporine, tacrolimus,||
0620|103|I|cancer chemotherapy, corticosteroids such as prednisone).||
0620|104|B|||
0620|105|O|OVERDOSE:  Not applicable.||
0620|106|B|||
0620|107|N|NOTES:  Keep all medical and lab appointments.||
0620|108|N|   Keep vaccine records for yourself and your children and||
0620|109|N|provide them to the health care professionals to prevent||
0620|110|N|unnecessary re-vaccinations.||
0620|111|B|||
0620|112|D|MISSED DOSE:  It is important that your child gets each||
0620|113|D|vaccination as scheduled. Ask when your child should get each||
0620|114|D|dose and mark your calendar with a reminder. If your child misses||
0620|115|D|a dose, call the health care professional to reschedule.||
0620|116|B|||
0620|117|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
0620|118|R|light. Keep all medications away from children and pets.||
0620|119|R|   Do not flush medications down the toilet or pour them into a||
0620|120|R|drain unless instructed to do so. Properly discard this product||
0620|121|R|when it is expired or no longer needed. Consult your pharmacist||
0620|122|R|or local waste disposal company.||
0620|123|B|||
0620|124|A|Information last revised February 2025.||
0620|125|A|Copyright(c) 2025 First Databank, Inc.||
0620|126|B|||
0622|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0622|002|Z|does NOT have all possible information about this product. This||
0622|003|Z|information does not assure that this product is safe, effective,||
0622|004|Z|or appropriate for you. This information is not individual||
0622|005|Z|medical advice and does not substitute for the advice of your||
0622|006|Z|health care professional. Always ask your health care||
0622|007|Z|professional for complete information about this product and your||
0622|008|Z|specific health needs.||
0622|009|B|||
0622|010|T|LUBIPROSTONE - ORAL||
0622|011|F|(loo-bi-PROST-own)||
0622|012|B|||
0622|013|C|COMMON BRAND NAME(S): Amitiza||
0622|014|B|||
0622|015|U|USES:  This medication is used to treat certain types of||
0622|016|U|constipation (chronic idiopathic constipation, irritable bowel||
0622|017|U|syndrome with constipation). Chronic idiopathic constipation has||
0622|018|U|an unknown cause and is not due to diet, other diseases, or||
0622|019|U|drugs.||
0622|020|U|   Lubiprostone is also used to treat constipation caused by||
0622|021|U|opioid medications in people with ongoing pain due to medical||
0622|022|U|conditions other than cancer.||
0622|023|U|   This medication may improve symptoms such as bloating and||
0622|024|U|abdominal discomfort, improve stool texture, lessen the need to||
0622|025|U|strain, and decrease the feeling of not completely relieving||
0622|026|U|oneself. Lubiprostone belongs to a class of drugs known as||
0622|027|U|chloride channel activators. It works by increasing the amount of||
0622|028|U|fluid within your intestines, making the passage of stool easier.||
0622|029|B|||
0622|030|H|HOW TO USE:  Take this medication by mouth with food and water as||
0622|031|H|directed by your doctor, usually twice daily. Swallow the||
0622|032|H|medication whole. Do not break or chew the medication.||
0622|033|H|   The dosage is based on your medical condition and response to||
0622|034|H|treatment.||
0622|035|H|   Use this medication regularly in order to get the most benefit||
0622|036|H|from it. Remember to take it at the same times each day.||
0622|037|H|   You should talk to your doctor regularly about whether you||
0622|038|H|still need this treatment.||
0622|039|H|   Tell your doctor if your condition lasts or gets worse.||
0622|040|B|||
0622|041|S|SIDE EFFECTS:  Nausea, diarrhea, gas, vomiting, dry mouth, runny||
0622|042|S|nose, cough, fever, headache, joint/back pain, or trouble||
0622|043|S|sleeping may occur. If any of these effects last or get worse,||
0622|044|S|tell your doctor or pharmacist promptly.||
0622|045|S|   Remember that this medication has been prescribed because your||
0622|046|S|doctor has judged that the benefit to you is greater than the||
0622|047|S|risk of side effects. Many people using this medication do not||
0622|048|S|have serious side effects.||
0622|049|S|   Tell your doctor right away if you have any serious side||
0622|050|S|effects, including: swelling of arms/legs, mental/mood changes.||
0622|051|S|   This medication may cause low blood pressure and possibly||
0622|052|S|fainting. Diarrhea and vomiting may increase the risk of these||
0622|053|S|side effects. Stop taking this medication and tell your doctor||
0622|054|S|right away if any of these serious side effects occur: fainting,||
0622|055|S|dizziness, severe diarrhea/vomiting.||
0622|056|S|   Lubiprostone may rarely cause trouble breathing and chest||
0622|057|S|tightness within 30 to 60 minutes after the first dose. This||
0622|058|S|reaction is usually not serious and generally goes away within 3||
0622|059|S|hours. It may happen again with other doses. However, you may not||
0622|060|S|be able to tell this reaction apart from a rare, severe reaction||
0622|061|S|that also causes trouble breathing and/or chest pain. Get medical||
0622|062|S|help right away if you develop any trouble breathing or chest||
0622|063|S|tightness/discomfort/pain.||
0622|064|S|   A very serious allergic reaction to this drug is rare.||
0622|065|S|However, get medical help right away if you notice any symptoms||
0622|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0622|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0622|068|S|breathing.||
0622|069|S|   This is not a complete list of possible side effects. If you||
0622|070|S|notice other effects not listed above, contact your doctor or||
0622|071|S|pharmacist.||
0622|072|S|   In the US -||
0622|073|S|   Call your doctor for medical advice about side effects. You||
0622|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0622|075|S|www.fda.gov/medwatch.||
0622|076|S|   In Canada - Call your doctor for medical advice about side||
0622|077|S|effects. You may report side effects to Health Canada at||
0622|078|S|1-866-234-2345.||
0622|079|B|||
0622|080|P|PRECAUTIONS:  Before taking lubiprostone, tell your doctor or||
0622|081|P|pharmacist if you are allergic to it; or if you have any other||
0622|082|P|allergies. This product may contain inactive ingredients, which||
0622|083|P|can cause allergic reactions or other problems. Talk to your||
0622|084|P|pharmacist for more details.||
0622|085|P|   Before using this medication, tell your doctor or pharmacist||
0622|086|P|your medical history, especially of: certain stomach/intestinal||
0622|087|P|problems (blockage, severe diarrhea), liver disease.||
0622|088|P|   Before having surgery, tell your doctor or dentist about all||
0622|089|P|the products you use (including prescription drugs,||
0622|090|P|nonprescription drugs, and herbal products).||
0622|091|P|   During pregnancy, this medication should be used only when||
0622|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
0622|093|P|   It is unknown if this drug passes into breast milk, but it may||
0622|094|P|have undesirable effects (such as causing diarrhea) on a nursing||
0622|095|P|infant. Consult your doctor before breastfeeding.||
0622|096|B|||
0622|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0622|098|I|medications work or increase your risk for serious side effects.||
0622|099|I|This document does not contain all possible drug interactions.||
0622|100|I|Keep a list of all the products you use (including||
0622|101|I|prescription/nonprescription drugs and herbal products) and share||
0622|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
0622|103|I|the dosage of any medicines without your doctor's approval.||
0622|104|B|||
0622|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0622|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0622|107|O|poison control center right away. US residents can call||
0622|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0622|109|O|Symptoms of overdose may include: fainting, flushing, paleness,||
0622|110|O|loss of appetite, sweating.||
0622|111|B|||
0622|112|N|NOTES:  Do not share this medication with others.||
0622|113|B|||
0622|114|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0622|115|D|remember. If it is near the time of the next dose, skip the||
0622|116|D|missed dose. Take your next dose at the regular time. Do not||
0622|117|D|double the dose to catch up.||
0622|118|B|||
0622|119|R|STORAGE:  Store at room temperature away from light and moisture.||
0622|120|R|Do not store in the bathroom. Keep all medications away from||
0622|121|R|children and pets.||
0622|122|R|   Do not flush medications down the toilet or pour them into a||
0622|123|R|drain unless instructed to do so. Properly discard this product||
0622|124|R|when it is expired or no longer needed. Consult your pharmacist||
0622|125|R|or local waste disposal company.||
0622|126|B|||
0622|127|A|Information last revised October 2024.||
0622|128|A|Copyright(c) 2025 First Databank, Inc.||
0622|129|B|||
0623|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0623|002|Z|does NOT have all possible information about this product. This||
0623|003|Z|information does not assure that this product is safe, effective,||
0623|004|Z|or appropriate for you. This information is not individual||
0623|005|Z|medical advice and does not substitute for the advice of your||
0623|006|Z|health care professional. Always ask your health care||
0623|007|Z|professional for complete information about this product and your||
0623|008|Z|specific health needs.||
0623|009|B|||
0623|010|T|ISOSORBIDE DINITRATE - ORAL||
0623|011|F|(EYE-soe-SOR-bide dye-NYE-trate)||
0623|012|B|||
0623|013|C|COMMON BRAND NAME(S): Isordil||
0623|014|B|||
0623|015|U|USES:  Isosorbide dinitrate is used to prevent chest pain||
0623|016|U|(angina) in patients with a certain heart condition (coronary||
0623|017|U|artery disease). This medication belongs to a class of drugs||
0623|018|U|known as nitrates. It works by relaxing and widening blood||
0623|019|U|vessels so blood can flow more easily to the heart.||
0623|020|U|   This medication will not relieve chest pain once it occurs. It||
0623|021|U|is also not intended to be taken just before physical activities||
0623|022|U|(such as exercise, sexual activity) to prevent chest pain. Other||
0623|023|U|medications may be needed in these situations. Consult your||
0623|024|U|doctor for more details.||
0623|025|B|||
0623|026|V|OTHER USES:  This section contains uses of this drug that are not||
0623|027|V|listed in the approved professional labeling for the drug but||
0623|028|V|that may be prescribed by your health care professional. Use this||
0623|029|V|drug for a condition that is listed in this section only if it||
0623|030|V|has been so prescribed by your health care professional.||
0623|031|V|   This medication may also be used with other drugs to improve||
0623|032|V|the symptoms of heart failure (such as trouble breathing).||
0623|033|B|||
0623|034|H|HOW TO USE:  Take this medication by mouth as directed by your||
0623|035|H|doctor, usually 2 to 3 times daily. It is important to take the||
0623|036|H|drug at the same times each day. Do not change the dosing times||
0623|037|H|unless directed by your doctor.||
0623|038|H|   Use this medication regularly to get the most benefit from it.||
0623|039|H|Do not suddenly stop taking this medication without consulting||
0623|040|H|your doctor. Some conditions may become worse when the drug is||
0623|041|H|suddenly stopped. Your dose may need to be gradually decreased.||
0623|042|H|   Although unlikely, when this medication is used for a long||
0623|043|H|time, it may not work as well and may require different dosing.||
0623|044|H|Tell your doctor if this medication stops working well (for||
0623|045|H|example, you have worsening chest pain or it occurs more often).||
0623|046|B|||
0623|047|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, nausea, and||
0623|048|S|flushing may occur as your body adjusts to this medication. If||
0623|049|S|any of these effects last or get worse, tell your doctor or||
0623|050|S|pharmacist promptly.||
0623|051|S|   Headache is often a sign that this medication is working. Your||
0623|052|S|doctor may recommend treating headaches with an over-the-counter||
0623|053|S|pain reliever (such as acetaminophen, aspirin). If the headaches||
0623|054|S|continue or become severe, tell your doctor promptly.||
0623|055|S|   To reduce the risk of dizziness and lightheadedness, get up||
0623|056|S|slowly when rising from a sitting or lying position.||
0623|057|S|   Remember that this medication has been prescribed because your||
0623|058|S|doctor has judged that the benefit to you is greater than the||
0623|059|S|risk of side effects. Many people using this medication do not||
0623|060|S|have serious side effects.||
0623|061|S|   Tell your doctor right away if you have any serious side||
0623|062|S|effects, including: fainting, fast/irregular/pounding heartbeat.||
0623|063|S|   A very serious allergic reaction to this drug is rare.||
0623|064|S|However, get medical help right away if you notice any symptoms||
0623|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0623|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0623|067|S|breathing.||
0623|068|S|   This is not a complete list of possible side effects. If you||
0623|069|S|notice other effects not listed above, contact your doctor or||
0623|070|S|pharmacist.||
0623|071|S|   In the US -||
0623|072|S|   Call your doctor for medical advice about side effects. You||
0623|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0623|074|S|www.fda.gov/medwatch.||
0623|075|S|   In Canada - Call your doctor for medical advice about side||
0623|076|S|effects. You may report side effects to Health Canada at||
0623|077|S|1-866-234-2345.||
0623|078|B|||
0623|079|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0623|080|P|pharmacist if you are allergic to it; or to similar drugs (such||
0623|081|P|as isosorbide mononitrate, nitroglycerin); or if you have any||
0623|082|P|other allergies. This product may contain inactive ingredients,||
0623|083|P|which can cause allergic reactions or other problems. Talk to||
0623|084|P|your pharmacist for more details.||
0623|085|P|   Before using this medication, tell your doctor or pharmacist||
0623|086|P|your medical history, especially of: recent head injury, anemia,||
0623|087|P|low blood pressure, dehydration, other heart problems (such as||
0623|088|P|recent heart attack).||
0623|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0623|090|P|can make you more dizzy. Do not drive, use machinery, or do||
0623|091|P|anything that needs alertness until you can do it safely. Limit||
0623|092|P|alcoholic beverages. Talk to your doctor if you are using||
0623|093|P|marijuana (cannabis).||
0623|094|P|   Before having surgery, tell your doctor or dentist about all||
0623|095|P|the products you use (including prescription drugs,||
0623|096|P|nonprescription drugs, and herbal products).||
0623|097|P|   Older adults may be more sensitive to the side effects of this||
0623|098|P|medication, especially dizziness and lightheadedness, which could||
0623|099|P|increase the risk of falls.||
0623|100|P|   During pregnancy, this medication should be used only when||
0623|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
0623|102|P|   It is unknown if this medication passes into breast milk.||
0623|103|P|Consult your doctor before breastfeeding.||
0623|104|B|||
0623|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0623|106|I|medications work or increase your risk for serious side effects.||
0623|107|I|This document does not contain all possible drug interactions.||
0623|108|I|Keep a list of all the products you use (including||
0623|109|I|prescription/nonprescription drugs and herbal products) and share||
0623|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0623|111|I|the dosage of any medicines without your doctor's approval.||
0623|112|I|   Some products that may interact with this drug include: drugs||
0623|113|I|to treat erectile dysfunction-ED or pulmonary hypertension (such||
0623|114|I|as sildenafil, tadalafil), certain drugs to treat migraine||
0623|115|I|headaches (ergot alkaloids such as ergotamine), riociguat,||
0623|116|I|vericiguat.||
0623|117|I|   Some products have ingredients that could worsen your heart||
0623|118|I|failure. Tell your pharmacist what products you are using, and||
0623|119|I|ask how to use them safely (especially cough-and-cold products,||
0623|120|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0623|121|I|   Isosorbide dinitrate is very similar to isosorbide||
0623|122|I|mononitrate. Do not use medications containing isosorbide||
0623|123|I|mononitrate while using isosorbide dinitrate.||
0623|124|I|   This medication may interfere with certain lab tests (such as||
0623|125|I|blood cholesterol levels), possibly causing false test results.||
0623|126|I|Make sure lab personnel and all your doctors know you use this||
0623|127|I|drug.||
0623|128|B|||
0623|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0623|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0623|131|O|poison control center right away. US residents can call||
0623|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0623|133|O|Symptoms of overdose may include: slow heartbeat, vision changes,||
0623|134|O|severe nausea/vomiting, sweating, cold/clammy skin, bluish||
0623|135|O|fingers/toes/lips.||
0623|136|B|||
0623|137|N|NOTES:  Do not share this medication with others.||
0623|138|N|   Lab and/or medical tests (such as blood pressure monitoring)||
0623|139|N|should be done while you are taking this medication. Keep all||
0623|140|N|medical and lab appointments. Consult your doctor for more||
0623|141|N|details.||
0623|142|N|   Lifestyle changes such as dietary changes, exercise, and||
0623|143|N|stopping smoking may help this drug work better. Talk to your||
0623|144|N|doctor or pharmacist about lifestyle changes that might benefit||
0623|145|N|you.||
0623|146|B|||
0623|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0623|148|D|remember. If it is within 2 hours of the next dose, skip the||
0623|149|D|missed dose. Take your next dose at the regular time. Do not||
0623|150|D|double the dose to catch up.||
0623|151|B|||
0623|152|R|STORAGE:  Store at room temperature away from light and moisture.||
0623|153|R|Do not store in the bathroom. Keep all medications away from||
0623|154|R|children and pets.||
0623|155|R|   Do not flush medications down the toilet or pour them into a||
0623|156|R|drain unless instructed to do so. Properly discard this product||
0623|157|R|when it is expired or no longer needed. Consult your pharmacist||
0623|158|R|or local waste disposal company.||
0623|159|B|||
0623|160|M|MEDICAL ALERT:  Your condition can cause complications in a||
0623|161|M|medical emergency. For information about enrolling in MedicAlert,||
0623|162|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0623|163|B|||
0623|164|A|Information last revised May 2024.||
0623|165|A|Copyright(c) 2025 First Databank, Inc.||
0623|166|B|||
0624|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0624|002|Z|does NOT have all possible information about this product. This||
0624|003|Z|information does not assure that this product is safe, effective,||
0624|004|Z|or appropriate for you. This information is not individual||
0624|005|Z|medical advice and does not substitute for the advice of your||
0624|006|Z|health care professional. Always ask your health care||
0624|007|Z|professional for complete information about this product and your||
0624|008|Z|specific health needs.||
0624|009|B|||
0624|010|T|HYOSCYAMINE EXTENDED-RELEASE - ORAL||
0624|011|F|(hi-oh-SYE-uh-meen)||
0624|012|B|||
0624|013|C|COMMON BRAND NAME(S): Levbid, Levsinex, Symax Duotab, Symax-SR||
0624|014|B|||
0624|015|U|USES:  Hyoscyamine is used to treat a variety of||
0624|016|U|stomach/intestinal problems such as cramps and irritable bowel||
0624|017|U|syndrome. It is also used to treat other conditions such as||
0624|018|U|bladder and bowel control problems, cramping pain caused by||
0624|019|U|kidney stones and gallstones, and Parkinson's disease. In||
0624|020|U|addition, it is used to decrease side effects of certain||
0624|021|U|medications (drugs used to treat myasthenia gravis) and||
0624|022|U|insecticides.||
0624|023|U|   This medication works by decreasing acid production in the||
0624|024|U|stomach, slowing down the natural movements of the gut, and||
0624|025|U|relaxing muscles in many organs (such as the stomach, intestines,||
0624|026|U|bladder, kidney, gallbladder). Hyoscyamine also lessens the||
0624|027|U|amount of certain body fluids (such as saliva, sweat). This||
0624|028|U|medication belongs to a class of drugs known as||
0624|029|U|anticholinergics/antispasmodics.||
0624|030|B|||
0624|031|H|HOW TO USE:  Take this medication by mouth as directed by your||
0624|032|H|doctor, usually every 12 hours.||
0624|033|H|   Swallow the extended-release capsules whole. Do not crush or||
0624|034|H|chew extended-release capsules or tablets. Doing so can release||
0624|035|H|all of the drug at once, increasing the risk of side effects.||
0624|036|H|Also, do not split the tablets unless they have a score line and||
0624|037|H|your doctor or pharmacist tells you to do so. Swallow the whole||
0624|038|H|or split tablet without crushing or chewing.||
0624|039|H|   The dosage is based on your medical condition and response to||
0624|040|H|treatment. Do not increase your dose or take it more often than||
0624|041|H|prescribed without consulting your doctor. Adults and children 12||
0624|042|H|years and older should not take more than 1.5 milligrams in 24||
0624|043|H|hours.||
0624|044|H|   Antacids may interfere with the absorption of this medication.||
0624|045|H|Ask your doctor or pharmacist for more information.||
0624|046|H|   Drink plenty of fluids while taking this medication unless||
0624|047|H|your doctor directs you otherwise.||
0624|048|H|   Tell your doctor if your condition lasts or gets worse.||
0624|049|B|||
0624|050|S|SIDE EFFECTS:  Dizziness, drowsiness, blurred vision, dry mouth,||
0624|051|S|headache, trouble sleeping, constipation, flushing, dry skin, and||
0624|052|S|decreased sweating may occur. If any of these effects last or get||
0624|053|S|worse, notify your doctor or pharmacist promptly.||
0624|054|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0624|055|S|chips, chew (sugarless) gum, drink water or use a saliva||
0624|056|S|substitute.||
0624|057|S|   An empty medication shell may appear in your stool. This is||
0624|058|S|harmless.||
0624|059|S|   Remember that this medication has been prescribed because your||
0624|060|S|doctor has judged that the benefit to you is greater than the||
0624|061|S|risk of side effects. Many people using this medication do not||
0624|062|S|have serious side effects.||
0624|063|S|   Tell your doctor right away if you have any serious side||
0624|064|S|effects, including: mental/mood changes (such as confusion,||
0624|065|S|unusual excitement), fast/irregular heartbeat, difficulty||
0624|066|S|urinating, decreased sexual ability, loss of coordination,||
0624|067|S|trouble speaking, vomiting.||
0624|068|S|   Get medical help right away if you have any very serious side||
0624|069|S|effects, including: eye pain/swelling/redness, vision changes||
0624|070|S|(such as seeing rainbows around lights at night).||
0624|071|S|   A very serious allergic reaction to this drug is rare.||
0624|072|S|However, get medical help right away if you notice any symptoms||
0624|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0624|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0624|075|S|breathing.||
0624|076|S|   This is not a complete list of possible side effects. If you||
0624|077|S|notice other effects not listed above, contact your doctor or||
0624|078|S|pharmacist.||
0624|079|S|   In the US -||
0624|080|S|   Call your doctor for medical advice about side effects. You||
0624|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0624|082|S|www.fda.gov/medwatch.||
0624|083|S|   In Canada - Call your doctor for medical advice about side||
0624|084|S|effects. You may report side effects to Health Canada at||
0624|085|S|1-866-234-2345.||
0624|086|B|||
0624|087|P|PRECAUTIONS:  Before taking hyoscyamine, tell your doctor or||
0624|088|P|pharmacist if you are allergic to it; or to atropine; or if you||
0624|089|P|have any other allergies. This product may contain inactive||
0624|090|P|ingredients, which can cause allergic reactions or other||
0624|091|P|problems. Talk to your pharmacist for more details.||
0624|092|P|   Before using this medication, tell your doctor or pharmacist||
0624|093|P|your medical history, especially of: personal or family history||
0624|094|P|of glaucoma (angle-closure type), enlarged prostate, urinary||
0624|095|P|blockage problems, certain stomach/intestinal problems (such as||
0624|096|P|slow gut, blockage, severe ulcerative colitis, infection),||
0624|097|P|overactive thyroid, heart problems (such as coronary heart||
0624|098|P|disease, heart failure, fast heartbeat, arrhythmias), high blood||
0624|099|P|pressure, kidney disease, heartburn problems (acid reflux, hiatal||
0624|100|P|hernia), certain nervous system problem (autonomic neuropathy),||
0624|101|P|myasthenia gravis.||
0624|102|P|   Contact lens wearers may need to use wetting eye drops since||
0624|103|P|this medication can cause dry eyes.||
0624|104|P|   This drug may make you dizzy or drowsy or blur your vision.||
0624|105|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0624|106|P|drowsy. Do not drive, use machinery, or do anything that needs||
0624|107|P|alertness or clear vision until you can do it safely. Limit||
0624|108|P|alcoholic beverages. Talk to your doctor if you are using||
0624|109|P|marijuana (cannabis).||
0624|110|P|   Before having surgery, tell your doctor or dentist about all||
0624|111|P|the products you use (including prescription drugs,||
0624|112|P|nonprescription drugs, and herbal products).||
0624|113|P|   This drug may make you sweat less, making you more likely to||
0624|114|P|get heat stroke. Avoid doing things that may cause you to||
0624|115|P|overheat, such as hard work or exercise in hot weather, or using||
0624|116|P|hot tubs. When the weather is hot, drink a lot of fluids and||
0624|117|P|dress lightly. If you overheat, quickly look for a place to cool||
0624|118|P|down and rest. Get medical help right away if you have a fever||
0624|119|P|that does not go away, mental/mood changes, headache, or||
0624|120|P|dizziness.||
0624|121|P|   Older adults may be more sensitive to the side effects of this||
0624|122|P|drug, especially confusion, drowsiness, unusual excitement,||
0624|123|P|constipation, and difficulty urinating. Confusion and drowsiness||
0624|124|P|can increase the risk of falling.||
0624|125|P|   Children may be more sensitive to the side effects of this||
0624|126|P|drug.||
0624|127|P|   During pregnancy, hyoscyamine should be used only when clearly||
0624|128|P|needed. Discuss the risks and benefits with your doctor.||
0624|129|P|   This drug passes into breast milk. Consult your doctor before||
0624|130|P|breastfeeding.||
0624|131|B|||
0624|132|I|DRUG INTERACTIONS:  See also How to Use section.||
0624|133|I|   Drug interactions may change how your medications work or||
0624|134|I|increase your risk for serious side effects. This document does||
0624|135|I|not contain all possible drug interactions. Keep a list of all||
0624|136|I|the products you use (including prescription/nonprescription||
0624|137|I|drugs and herbal products) and share it with your doctor and||
0624|138|I|pharmacist. Do not start, stop, or change the dosage of any||
0624|139|I|medicines without your doctor's approval.||
0624|140|I|   Some products that may interact with this drug are: certain||
0624|141|I|azole anti-fungal drugs (ketoconazole, itraconazole),||
0624|142|I|bisphosphonate drugs (such as alendronate, risedronate),||
0624|143|I|corticosteroids (such as prednisone), digoxin (slow-dissolving||
0624|144|I|tablets), potassium tablets/capsules, pramlintide.||
0624|145|I|   Tell your doctor or pharmacist if you are taking other||
0624|146|I|products that cause drowsiness such as opioid pain or cough||
0624|147|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0624|148|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0624|149|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0624|150|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0624|151|I|diphenhydramine).||
0624|152|I|   Check the labels on all your medicines (such as allergy or||
0624|153|I|cough-and-cold products) because they may contain ingredients||
0624|154|I|that cause drowsiness. Ask your pharmacist about using those||
0624|155|I|products safely.||
0624|156|I|   This medication may interfere with certain lab tests, possibly||
0624|157|I|causing false test results. Make sure lab personnel and all your||
0624|158|I|doctors know you use this drug.||
0624|159|B|||
0624|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0624|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0624|162|O|poison control center right away. US residents can call||
0624|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0624|164|O|Symptoms of overdose may include hot/dry skin, fever, unusual||
0624|165|O|excitement, fast/irregular heartbeat, seizures.||
0624|166|B|||
0624|167|N|NOTES:  Do not share this medication with others.||
0624|168|N|   Management of digestive disorders may include lifestyle||
0624|169|N|changes such as stress reduction programs, exercise, stopping||
0624|170|N|smoking, and dietary changes to increase the effectiveness of||
0624|171|N|this medicine. Talk to your doctor or pharmacist about lifestyle||
0624|172|N|changes that might benefit you.||
0624|173|B|||
0624|174|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0624|175|D|remember. If it is near the time of the next dose, skip the||
0624|176|D|missed dose. Take your next dose at the regular time. Do not||
0624|177|D|double the dose to catch up.||
0624|178|B|||
0624|179|R|STORAGE:  Store at room temperature away from light and moisture.||
0624|180|R|Do not store in the bathroom. Keep all medications away from||
0624|181|R|children and pets.||
0624|182|R|   Do not flush medications down the toilet or pour them into a||
0624|183|R|drain unless instructed to do so. Properly discard this product||
0624|184|R|when it is expired or no longer needed. Consult your pharmacist||
0624|185|R|or local waste disposal company.||
0624|186|B|||
0624|187|A|Information last revised October 2025.||
0624|188|A|Copyright(c) 2025 First Databank, Inc.||
0624|189|B|||
0625|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0625|002|Z|does NOT have all possible information about this product. This||
0625|003|Z|information does not assure that this product is safe, effective,||
0625|004|Z|or appropriate for you. This information is not individual||
0625|005|Z|medical advice and does not substitute for the advice of your||
0625|006|Z|health care professional. Always ask your health care||
0625|007|Z|professional for complete information about this product and your||
0625|008|Z|specific health needs.||
0625|009|B|||
0625|010|T|HYOSCYAMINE ELIXIR - ORAL||
0625|011|F|(hi-oh-SYE-uh-meen)||
0625|012|B|||
0625|013|C|COMMON BRAND NAME(S): Hyosyne, Levsin||
0625|014|B|||
0625|015|U|USES:  Hyoscyamine is used to treat a variety of||
0625|016|U|stomach/intestinal problems such as cramps, infant colic, and||
0625|017|U|irritable bowel syndrome. It is also used to treat other||
0625|018|U|conditions such as bladder and bowel control problems, cramping||
0625|019|U|pain caused by kidney stones and gallstones, and Parkinson's||
0625|020|U|disease. In addition, it is used to decrease side effects of||
0625|021|U|certain medications (drugs used to treat myasthenia gravis) and||
0625|022|U|insecticides.||
0625|023|U|   This medication works by decreasing acid production in the||
0625|024|U|stomach, slowing down the natural movements of the gut, and||
0625|025|U|relaxing muscles in many organs (such as the stomach, intestines,||
0625|026|U|bladder, kidney, gallbladder). Hyoscyamine also lessens the||
0625|027|U|amount of certain body fluids (such as saliva, sweat). This||
0625|028|U|medication belongs to a class of drugs known as||
0625|029|U|anticholinergics/antispasmodics.||
0625|030|B|||
0625|031|H|HOW TO USE:  Take this medication by mouth as directed by your||
0625|032|H|doctor, usually 30 to 60 minutes before meals. Measure the dose||
0625|033|H|out carefully with a medication spoon/cup.||
0625|034|H|   The dosage is based on your medical condition and response to||
0625|035|H|treatment. Children's dosage is also based on weight. Do not||
0625|036|H|increase your dose or take it more often than prescribed without||
0625|037|H|consulting your doctor. Adults and children 12 years and older||
0625|038|H|should not take more than 1.5 milligrams in 24 hours. Children||
0625|039|H|aged 2 to 12 years should not take more than 0.75 milligrams in||
0625|040|H|24 hours. Ask your doctor or pharmacist for more information.||
0625|041|H|   Antacids lower the absorption of hyoscyamine. If you use||
0625|042|H|antacids, take them after meals and take hyoscyamine before||
0625|043|H|meals; or take antacids at least 1 hour after taking hyoscyamine.||
0625|044|H|   Drink plenty of fluids while taking this medication unless||
0625|045|H|your doctor directs you otherwise.||
0625|046|H|   Tell your doctor if your condition lasts or gets worse.||
0625|047|B|||
0625|048|S|SIDE EFFECTS:  Dizziness, drowsiness, blurred vision, dry mouth,||
0625|049|S|headache, trouble sleeping, constipation, flushing, dry skin, and||
0625|050|S|decreased sweating may occur. If any of these effects last or get||
0625|051|S|worse, notify your doctor or pharmacist promptly.||
0625|052|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0625|053|S|chips, chew (sugarless) gum, drink water or use a saliva||
0625|054|S|substitute.||
0625|055|S|   Remember that this medication has been prescribed because your||
0625|056|S|doctor has judged that the benefit to you is greater than the||
0625|057|S|risk of side effects. Many people using this medication do not||
0625|058|S|have serious side effects.||
0625|059|S|   Tell your doctor right away if you have any serious side||
0625|060|S|effects, including: mental/mood changes (such as confusion,||
0625|061|S|unusual excitement), fast/irregular heartbeat, difficulty||
0625|062|S|urinating, decreased sexual ability, loss of coordination,||
0625|063|S|trouble speaking, vomiting.||
0625|064|S|   Get medical help right away if you have any very serious side||
0625|065|S|effects, including: eye pain/swelling/redness, vision changes||
0625|066|S|(such as seeing rainbows around lights at night).||
0625|067|S|   A very serious allergic reaction to this drug is rare.||
0625|068|S|However, get medical help right away if you notice any symptoms||
0625|069|S|of a serious allergic reaction, including: rash, itching/swelling||
0625|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0625|071|S|breathing.||
0625|072|S|   This is not a complete list of possible side effects. If you||
0625|073|S|notice other effects not listed above, contact your doctor or||
0625|074|S|pharmacist.||
0625|075|S|   In the US -||
0625|076|S|   Call your doctor for medical advice about side effects. You||
0625|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0625|078|S|www.fda.gov/medwatch.||
0625|079|S|   In Canada - Call your doctor for medical advice about side||
0625|080|S|effects. You may report side effects to Health Canada at||
0625|081|S|1-866-234-2345.||
0625|082|B|||
0625|083|P|PRECAUTIONS:  Before taking hyoscyamine, tell your doctor or||
0625|084|P|pharmacist if you are allergic to it; or to atropine; or if you||
0625|085|P|have any other allergies. This product may contain inactive||
0625|086|P|ingredients, which can cause allergic reactions or other||
0625|087|P|problems. Talk to your pharmacist for more details.||
0625|088|P|   Before using this medication, tell your doctor or pharmacist||
0625|089|P|your medical history, especially of: personal or family history||
0625|090|P|of glaucoma (angle-closure type), enlarged prostate, urinary||
0625|091|P|blockage problems, certain stomach/intestinal problems (such as||
0625|092|P|slow gut, blockage, severe ulcerative colitis, infection),||
0625|093|P|overactive thyroid, heart problems (such as coronary heart||
0625|094|P|disease, heart failure, fast heartbeat, arrhythmias), high blood||
0625|095|P|pressure, kidney disease, heartburn problems (acid reflux, hiatal||
0625|096|P|hernia), certain nervous system problem (autonomic neuropathy),||
0625|097|P|myasthenia gravis.||
0625|098|P|   Contact lens wearers may need to use wetting eye drops since||
0625|099|P|this medication can cause dry eyes.||
0625|100|P|   This medication may contain alcohol. Caution is advised if you||
0625|101|P|have alcohol dependence or liver disease. Ask your doctor or||
0625|102|P|pharmacist about the safe use of this product.||
0625|103|P|   This drug may make you dizzy or drowsy or blur your vision.||
0625|104|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0625|105|P|drowsy. Do not drive, use machinery, or do anything that needs||
0625|106|P|alertness or clear vision until you can do it safely. Limit||
0625|107|P|alcoholic beverages. Talk to your doctor if you are using||
0625|108|P|marijuana (cannabis).||
0625|109|P|   Before having surgery, tell your doctor or dentist about all||
0625|110|P|the products you use (including prescription drugs,||
0625|111|P|nonprescription drugs, and herbal products).||
0625|112|P|   This drug may make you sweat less, making you more likely to||
0625|113|P|get heat stroke. Avoid doing things that may cause you to||
0625|114|P|overheat, such as hard work or exercise in hot weather, or using||
0625|115|P|hot tubs. When the weather is hot, drink a lot of fluids and||
0625|116|P|dress lightly. If you overheat, quickly look for a place to cool||
0625|117|P|down and rest. Get medical help right away if you have a fever||
0625|118|P|that does not go away, mental/mood changes, headache, or||
0625|119|P|dizziness.||
0625|120|P|   Older adults may be more sensitive to the side effects of this||
0625|121|P|drug, especially confusion, drowsiness, unusual excitement,||
0625|122|P|constipation, and difficulty urinating. Confusion and drowsiness||
0625|123|P|can increase the risk of falling.||
0625|124|P|   Children may be more sensitive to the side effects of this||
0625|125|P|drug.||
0625|126|P|   During pregnancy, hyoscyamine should be used only when clearly||
0625|127|P|needed. Discuss the risks and benefits with your doctor.||
0625|128|P|   This drug passes into breast milk. Consult your doctor before||
0625|129|P|breastfeeding.||
0625|130|B|||
0625|131|I|DRUG INTERACTIONS:  See also How to Use section.||
0625|132|I|   Drug interactions may change how your medications work or||
0625|133|I|increase your risk for serious side effects. This document does||
0625|134|I|not contain all possible drug interactions. Keep a list of all||
0625|135|I|the products you use (including prescription/nonprescription||
0625|136|I|drugs and herbal products) and share it with your doctor and||
0625|137|I|pharmacist. Do not start, stop, or change the dosage of any||
0625|138|I|medicines without your doctor's approval.||
0625|139|I|   Some products that may interact with this drug are: certain||
0625|140|I|azole anti-fungal drugs (ketoconazole, itraconazole),||
0625|141|I|bisphosphonate drugs (such as alendronate, risedronate),||
0625|142|I|corticosteroids (such as prednisone), digoxin (slow-dissolving||
0625|143|I|tablets), potassium tablets/capsules, pramlintide.||
0625|144|I|   Tell your doctor or pharmacist if you are taking other||
0625|145|I|products that cause drowsiness such as opioid pain or cough||
0625|146|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0625|147|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0625|148|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0625|149|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0625|150|I|diphenhydramine).||
0625|151|I|   Check the labels on all your medicines (such as allergy or||
0625|152|I|cough-and-cold products) because they may contain ingredients||
0625|153|I|that cause drowsiness. Ask your pharmacist about using those||
0625|154|I|products safely.||
0625|155|I|   This medication may interfere with certain lab tests, possibly||
0625|156|I|causing false test results. Make sure lab personnel and all your||
0625|157|I|doctors know you use this drug.||
0625|158|B|||
0625|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0625|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0625|161|O|poison control center right away. US residents can call||
0625|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0625|163|O|Symptoms of overdose may include hot/dry skin, fever, unusual||
0625|164|O|excitement, fast/irregular heartbeat, seizures.||
0625|165|B|||
0625|166|N|NOTES:  Do not share this medication with others.||
0625|167|N|   Management of digestive disorders may include lifestyle||
0625|168|N|changes such as stress reduction programs, exercise, stopping||
0625|169|N|smoking, and dietary changes to increase the effectiveness of||
0625|170|N|this medicine. Talk to your doctor or pharmacist about lifestyle||
0625|171|N|changes that might benefit you.||
0625|172|B|||
0625|173|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0625|174|D|remember. If it is near the time of the next dose, skip the||
0625|175|D|missed dose. Take your next dose at the regular time. Do not||
0625|176|D|double the dose to catch up.||
0625|177|B|||
0625|178|R|STORAGE:  Store at room temperature away from light and moisture.||
0625|179|R|Do not store in the bathroom. Keep all medications away from||
0625|180|R|children and pets.||
0625|181|R|   Do not flush medications down the toilet or pour them into a||
0625|182|R|drain unless instructed to do so. Properly discard this product||
0625|183|R|when it is expired or no longer needed. Consult your pharmacist||
0625|184|R|or local waste disposal company.||
0625|185|B|||
0625|186|A|Information last revised October 2025.||
0625|187|A|Copyright(c) 2025 First Databank, Inc.||
0625|188|B|||
0626|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0626|002|Z|does NOT have all possible information about this product. This||
0626|003|Z|information does not assure that this product is safe, effective,||
0626|004|Z|or appropriate for you. This information is not individual||
0626|005|Z|medical advice and does not substitute for the advice of your||
0626|006|Z|health care professional. Always ask your health care||
0626|007|Z|professional for complete information about this product and your||
0626|008|Z|specific health needs.||
0626|009|B|||
0626|010|T|HYOSCYAMINE DROPS - ORAL||
0626|011|F|(hi-oh-SYE-uh-meen)||
0626|012|B|||
0626|013|C|COMMON BRAND NAME(S): Hyosyne, Levsin||
0626|014|B|||
0626|015|U|USES:  Hyoscyamine is used to treat a variety of||
0626|016|U|stomach/intestinal problems such as cramps, infant colic, and||
0626|017|U|irritable bowel syndrome. It is also used to treat other||
0626|018|U|conditions such as bladder and bowel control problems, cramping||
0626|019|U|pain caused by kidney stones and gallstones, and Parkinson's||
0626|020|U|disease. In addition, it is used to decrease side effects of||
0626|021|U|certain medications (drugs used to treat myasthenia gravis) and||
0626|022|U|insecticides.||
0626|023|U|   This medication works by decreasing acid production in the||
0626|024|U|stomach, slowing down the natural movements of the gut, and||
0626|025|U|relaxing muscles in many organs (such as the stomach, intestines,||
0626|026|U|bladder, kidney, gallbladder). Hyoscyamine also lessens the||
0626|027|U|amount of certain body fluids (such as saliva, sweat). This||
0626|028|U|medication belongs to a class of drugs known as||
0626|029|U|anticholinergics/antispasmodics.||
0626|030|B|||
0626|031|H|HOW TO USE:  Take this medication by mouth as directed by your||
0626|032|H|doctor, usually 30 to 60 minutes before meals. Use the dropper||
0626|033|H|that comes with this product to measure the dose out carefully.||
0626|034|H|   The dosage is based on your medical condition and response to||
0626|035|H|treatment. Children's dosage may also based on weight. Do not||
0626|036|H|increase your dose or take it more often than prescribed without||
0626|037|H|consulting your doctor. Adults and children 12 years and older||
0626|038|H|should not take more than 1.5 milligrams in 24 hours. Children||
0626|039|H|aged 2 to 12 years should not take more than 0.75 milligrams in||
0626|040|H|24 hours. Ask your doctor or pharmacist for more information.||
0626|041|H|   Antacids lower the absorption of hyoscyamine. If you use||
0626|042|H|antacids, take them after meals and take hyoscyamine before||
0626|043|H|meals; or take antacids at least 1 hour after taking hyoscyamine.||
0626|044|H|   Drink plenty of fluids while taking this medication unless||
0626|045|H|your doctor directs you otherwise.||
0626|046|H|   Tell your doctor if your condition lasts or gets worse.||
0626|047|B|||
0626|048|S|SIDE EFFECTS:  Dizziness, drowsiness, blurred vision, dry mouth,||
0626|049|S|headache, trouble sleeping, constipation, flushing, dry skin, and||
0626|050|S|decreased sweating may occur. If any of these effects last or get||
0626|051|S|worse, notify your doctor or pharmacist promptly.||
0626|052|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0626|053|S|chips, chew (sugarless) gum, drink water or use a saliva||
0626|054|S|substitute.||
0626|055|S|   Remember that this medication has been prescribed because your||
0626|056|S|doctor has judged that the benefit to you is greater than the||
0626|057|S|risk of side effects. Many people using this medication do not||
0626|058|S|have serious side effects.||
0626|059|S|   Tell your doctor right away if you have any serious side||
0626|060|S|effects, including: mental/mood changes (such as confusion,||
0626|061|S|unusual excitement), fast/irregular heartbeat, difficulty||
0626|062|S|urinating, decreased sexual ability, loss of coordination,||
0626|063|S|trouble speaking, vomiting.||
0626|064|S|   Get medical help right away if you have any very serious side||
0626|065|S|effects, including: eye pain/swelling/redness, vision changes||
0626|066|S|(such as seeing rainbows around lights at night).||
0626|067|S|   A very serious allergic reaction to this drug is rare.||
0626|068|S|However, get medical help right away if you notice any symptoms||
0626|069|S|of a serious allergic reaction, including: rash, itching/swelling||
0626|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0626|071|S|breathing.||
0626|072|S|   This is not a complete list of possible side effects. If you||
0626|073|S|notice other effects not listed above, contact your doctor or||
0626|074|S|pharmacist.||
0626|075|S|   In the US -||
0626|076|S|   Call your doctor for medical advice about side effects. You||
0626|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0626|078|S|www.fda.gov/medwatch.||
0626|079|S|   In Canada - Call your doctor for medical advice about side||
0626|080|S|effects. You may report side effects to Health Canada at||
0626|081|S|1-866-234-2345.||
0626|082|B|||
0626|083|P|PRECAUTIONS:  Before taking hyoscyamine, tell your doctor or||
0626|084|P|pharmacist if you are allergic to it; or to atropine; or if you||
0626|085|P|have any other allergies. This product may contain inactive||
0626|086|P|ingredients, which can cause allergic reactions or other||
0626|087|P|problems. Talk to your pharmacist for more details.||
0626|088|P|   Before using this medication, tell your doctor or pharmacist||
0626|089|P|your medical history, especially of: personal or family history||
0626|090|P|of glaucoma (angle-closure type), enlarged prostate, urinary||
0626|091|P|blockage problems, certain stomach/intestinal problems (such as||
0626|092|P|slow gut, blockage, severe ulcerative colitis, infection),||
0626|093|P|overactive thyroid, heart problems (such as coronary heart||
0626|094|P|disease, heart failure, fast heartbeat, arrhythmias), high blood||
0626|095|P|pressure, kidney disease, heartburn problems (acid reflux, hiatal||
0626|096|P|hernia), certain nervous system problem (autonomic neuropathy),||
0626|097|P|myasthenia gravis.||
0626|098|P|   Contact lens wearers may need to use wetting eye drops since||
0626|099|P|this medication can cause dry eyes.||
0626|100|P|   This drug may make you dizzy or drowsy or blur your vision.||
0626|101|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0626|102|P|drowsy. Do not drive, use machinery, or do anything that needs||
0626|103|P|alertness or clear vision until you can do it safely. Limit||
0626|104|P|alcoholic beverages. Talk to your doctor if you are using||
0626|105|P|marijuana (cannabis).||
0626|106|P|   Before having surgery, tell your doctor or dentist about all||
0626|107|P|the products you use (including prescription drugs,||
0626|108|P|nonprescription drugs, and herbal products).||
0626|109|P|   This drug may make you sweat less, making you more likely to||
0626|110|P|get heat stroke. Avoid doing things that may cause you to||
0626|111|P|overheat, such as hard work or exercise in hot weather, or using||
0626|112|P|hot tubs. When the weather is hot, drink a lot of fluids and||
0626|113|P|dress lightly. If you overheat, quickly look for a place to cool||
0626|114|P|down and rest. Get medical help right away if you have a fever||
0626|115|P|that does not go away, mental/mood changes, headache, or||
0626|116|P|dizziness.||
0626|117|P|   Older adults may be more sensitive to the side effects of this||
0626|118|P|drug, especially confusion, drowsiness, unusual excitement,||
0626|119|P|constipation, and difficulty urinating. Confusion and drowsiness||
0626|120|P|can increase the risk of falling.||
0626|121|P|   Children may be more sensitive to the side effects of this||
0626|122|P|drug.||
0626|123|P|   During pregnancy, hyoscyamine should be used only when clearly||
0626|124|P|needed. Discuss the risks and benefits with your doctor.||
0626|125|P|   This drug passes into breast milk. Consult your doctor before||
0626|126|P|breastfeeding.||
0626|127|B|||
0626|128|I|DRUG INTERACTIONS:  See also How to Use section.||
0626|129|I|   Drug interactions may change how your medications work or||
0626|130|I|increase your risk for serious side effects. This document does||
0626|131|I|not contain all possible drug interactions. Keep a list of all||
0626|132|I|the products you use (including prescription/nonprescription||
0626|133|I|drugs and herbal products) and share it with your doctor and||
0626|134|I|pharmacist. Do not start, stop, or change the dosage of any||
0626|135|I|medicines without your doctor's approval.||
0626|136|I|   Some products that may interact with this drug are: certain||
0626|137|I|azole anti-fungal drugs (ketoconazole, itraconazole),||
0626|138|I|bisphosphonate drugs (such as alendronate, risedronate),||
0626|139|I|corticosteroids (such as prednisone), digoxin (slow-dissolving||
0626|140|I|tablets), potassium tablets/capsules, pramlintide.||
0626|141|I|   Tell your doctor or pharmacist if you are taking other||
0626|142|I|products that cause drowsiness such as opioid pain or cough||
0626|143|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0626|144|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0626|145|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0626|146|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0626|147|I|diphenhydramine).||
0626|148|I|   Check the labels on all your medicines (such as allergy or||
0626|149|I|cough-and-cold products) because they may contain ingredients||
0626|150|I|that cause drowsiness. Ask your pharmacist about using those||
0626|151|I|products safely.||
0626|152|I|   This medication may interfere with certain lab tests, possibly||
0626|153|I|causing false test results. Make sure lab personnel and all your||
0626|154|I|doctors know you use this drug.||
0626|155|B|||
0626|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0626|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0626|158|O|poison control center right away. US residents can call||
0626|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0626|160|O|Symptoms of overdose may include hot/dry skin, fever, unusual||
0626|161|O|excitement, fast/irregular heartbeat, seizures.||
0626|162|B|||
0626|163|N|NOTES:  Do not share this medication with others.||
0626|164|N|   Management of digestive disorders may include lifestyle||
0626|165|N|changes such as stress reduction programs, exercise, stopping||
0626|166|N|smoking, and dietary changes to increase the effectiveness of||
0626|167|N|this medicine. Talk to your doctor or pharmacist about lifestyle||
0626|168|N|changes that might benefit you.||
0626|169|B|||
0626|170|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0626|171|D|remember. If it is near the time of the next dose, skip the||
0626|172|D|missed dose. Take your next dose at the regular time. Do not||
0626|173|D|double the dose to catch up.||
0626|174|B|||
0626|175|R|STORAGE:  Store at room temperature away from light and moisture.||
0626|176|R|Do not store in the bathroom. Keep all medications away from||
0626|177|R|children and pets.||
0626|178|R|   Do not flush medications down the toilet or pour them into a||
0626|179|R|drain unless instructed to do so. Properly discard this product||
0626|180|R|when it is expired or no longer needed. Consult your pharmacist||
0626|181|R|or local waste disposal company.||
0626|182|B|||
0626|183|A|Information last revised October 2025.||
0626|184|A|Copyright(c) 2025 First Databank, Inc.||
0626|185|B|||
0628|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0628|002|Z|does NOT have all possible information about this product. This||
0628|003|Z|information does not assure that this product is safe, effective,||
0628|004|Z|or appropriate for you. This information is not individual||
0628|005|Z|medical advice and does not substitute for the advice of your||
0628|006|Z|health care professional. Always ask your health care||
0628|007|Z|professional for complete information about this product and your||
0628|008|Z|specific health needs.||
0628|009|B|||
0628|010|T|DESOGESTREL/ETHINYL ESTRADIOL - ETHINYL ESTRADIOL - ORAL||
0628|011|F|(DES-oh-JES-trel/ETH-i-nil ES-tra-DYE-ol/ETH-i-nil ES-tra-DYE-ol)||
0628|012|B|||
0628|013|C|COMMON BRAND NAME(S): Kariva, Mircette||
0628|014|B|||
0628|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
0628|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
0628|017|W|stroke, heart attack, blood clots, and high blood pressure from||
0628|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
0628|019|W|of these serious problems increases with age and with the number||
0628|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
0628|021|B|||
0628|022|U|USES:  This combination hormone medication is used to prevent||
0628|023|U|pregnancy. It contains 2 hormones: a progestin (desogestrel) and||
0628|024|U|an estrogen (ethinyl estradiol).||
0628|025|U|   Besides preventing pregnancy, birth control pills may make||
0628|026|U|your periods more regular, decrease blood loss and painful||
0628|027|U|periods, decrease your risk of ovarian cysts, and also treat||
0628|028|U|acne.||
0628|029|U|   This medication does not protect against sexually transmitted||
0628|030|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
0628|031|U|an effective barrier method (latex or polyurethane condom/dental||
0628|032|U|dams) during sexual activity will help to decrease your risk of||
0628|033|U|infection.||
0628|034|B|||
0628|035|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0628|036|H|your pharmacist before you start using this product and each time||
0628|037|H|you get a refill. The leaflet contains very important information||
0628|038|H|on when to take your pills and what to do if you miss a dose. If||
0628|039|H|you have any questions, ask your doctor or pharmacist.||
0628|040|H|   Take this medication by mouth as directed by your doctor,||
0628|041|H|usually once daily. Pick a time of day that is easy for you to||
0628|042|H|remember, and take your pill at the same time each day.||
0628|043|H|   It is very important to keep taking this medication exactly as||
0628|044|H|prescribed by your doctor. Follow the package instructions to||
0628|045|H|find the first tablet, start with the first tablet in the pack,||
0628|046|H|and take them in the correct order. Do not skip any doses.||
0628|047|H|Pregnancy is more likely if you miss pills, start a new pack||
0628|048|H|late, or take your pill at a different time of the day than||
0628|049|H|usual.||
0628|050|H|   Vomiting or diarrhea can prevent your birth control pills from||
0628|051|H|working well. If you have vomiting or diarrhea, you may need to||
0628|052|H|use a backup birth control method (such as condoms, spermicide).||
0628|053|H|Follow the directions in the Patient Information Leaflet and||
0628|054|H|check with your doctor or pharmacist for more details.||
0628|055|H|   Taking this medication after your evening meal or at bedtime||
0628|056|H|may help if you have stomach upset or nausea with the medication.||
0628|057|H|You may choose to take this medication at another time of day||
0628|058|H|that is easier for you to remember. No matter what dosing||
0628|059|H|schedule you use, it is very important that you take this||
0628|060|H|medication at the same time each day, 24 hours apart. Ask your||
0628|061|H|doctor or pharmacist if you have any questions.||
0628|062|H|   Your pill pack contains 21 pills (enough for 3 weeks) with a||
0628|063|H|combination of estrogen and progestin. The last week of the pack||
0628|064|H|contains 2 reminder pills with no medication and 5 pills that||
0628|065|H|have a low dose of estrogen. Take one active pill (with both||
0628|066|H|hormones) once daily for 21 days in a row. After the combination||
0628|067|H|pills are finished, keep taking 1 tablet daily, starting with the||
0628|068|H|2 reminder tablets and finishing with the 5 estrogen-only||
0628|069|H|tablets, unless otherwise directed by your doctor. You should||
0628|070|H|have your period during the fourth week of the pack. After you||
0628|071|H|have taken the last estrogen-only tablet in the pack, start a new||
0628|072|H|pack the next day whether or not you have your period. If you do||
0628|073|H|not get your period, consult your doctor.||
0628|074|H|   If this is the first time you are using this medication and||
0628|075|H|you are not switching from another form of hormonal birth control||
0628|076|H|(such as patch, other birth control pills), take the first tablet||
0628|077|H|in the pack on the first Sunday following the beginning of your||
0628|078|H|menstrual period or on the first day of your period. If your||
0628|079|H|period begins on a Sunday, begin taking this medication on that||
0628|080|H|day. For the first cycle of use only, use a backup form of||
0628|081|H|non-hormonal birth control (such as condoms, spermicide) for the||
0628|082|H|first 7 days to prevent pregnancy until the medication has enough||
0628|083|H|time to work. If you start on the first day of your period, you||
0628|084|H|do not need to use backup birth control the first week.||
0628|085|H|   Ask your doctor or pharmacist about how to switch from other||
0628|086|H|forms of hormonal birth control (such as patch, other birth||
0628|087|H|control pills) to this product. If any information is unclear,||
0628|088|H|consult the Patient Information Leaflet or your doctor or||
0628|089|H|pharmacist.||
0628|090|B|||
0628|091|S|SIDE EFFECTS:  Nausea, vomiting, headache, bloating, breast||
0628|092|S|tenderness, swelling of the ankles/feet (fluid retention), or||
0628|093|S|weight change may occur. Vaginal bleeding between periods||
0628|094|S|(spotting) or missed/irregular periods may occur, especially||
0628|095|S|during the first few months of use. If any of these effects last||
0628|096|S|or get worse, tell your doctor or pharmacist promptly. If you||
0628|097|S|miss 2 periods in a row (or 1 period if the pill has not been||
0628|098|S|used properly), contact your doctor for a pregnancy test.||
0628|099|S|   Remember that this medication has been prescribed because your||
0628|100|S|doctor has judged that the benefit to you is greater than the||
0628|101|S|risk of side effects. Many people using this medication do not||
0628|102|S|have serious side effects.||
0628|103|S|   This medication may raise your blood pressure. Check your||
0628|104|S|blood pressure regularly and tell your doctor if the results are||
0628|105|S|high.||
0628|106|S|   Tell your doctor right away if you have any serious side||
0628|107|S|effects, including: lumps in the breast, mental/mood changes||
0628|108|S|(such as new/worsening depression), severe stomach/abdominal||
0628|109|S|pain, unusual changes in vaginal bleeding (such as continuous||
0628|110|S|spotting, sudden heavy bleeding, missed periods), dark urine,||
0628|111|S|yellowing eyes/skin.||
0628|112|S|   This medication may rarely cause serious (sometimes fatal)||
0628|113|S|problems from blood clots (such as heart attack, stroke, blood||
0628|114|S|clots in the lungs or legs). Get medical help right away if you||
0628|115|S|have: chest/jaw/left arm pain, confusion, sudden||
0628|116|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0628|117|S|trouble speaking, shortness of breath/rapid breathing,||
0628|118|S|sudden/severe headaches, unusual sweating, weakness on one side||
0628|119|S|of the body, sudden vision changes.||
0628|120|S|   A very serious allergic reaction to this drug is rare.||
0628|121|S|However, get medical help right away if you notice any symptoms||
0628|122|S|of a serious allergic reaction, including: rash, itching/swelling||
0628|123|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0628|124|S|breathing.||
0628|125|S|   This is not a complete list of possible side effects. If you||
0628|126|S|notice other effects not listed above, contact your doctor or||
0628|127|S|pharmacist.||
0628|128|S|   In the US -||
0628|129|S|   Call your doctor for medical advice about side effects. You||
0628|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0628|131|S|www.fda.gov/medwatch.||
0628|132|S|   In Canada - Call your doctor for medical advice about side||
0628|133|S|effects. You may report side effects to Health Canada at||
0628|134|S|1-866-234-2345.||
0628|135|B|||
0628|136|P|PRECAUTIONS:  See also Warning section.||
0628|137|P|   Before using this medication, tell your doctor or pharmacist||
0628|138|P|if you are allergic to ethinyl estradiol or desogestrel; or to||
0628|139|P|any other estrogen or progestin; or if you have any other||
0628|140|P|allergies. This product may contain inactive ingredients, which||
0628|141|P|can cause allergic reactions or other problems. Talk to your||
0628|142|P|pharmacist for more details.||
0628|143|P|   Before using this medication, tell your doctor or pharmacist||
0628|144|P|your medical history, especially of: blood clots (for example, in||
0628|145|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
0628|146|P|C or protein S deficiency), high blood pressure, abnormal breast||
0628|147|P|exam, cancer (especially endometrial or breast cancer), high||
0628|148|P|cholesterol or triglyceride (blood fat) levels, depression,||
0628|149|P|diabetes, family or personal history of a certain swelling||
0628|150|P|disorder (angioedema), gallbladder problems, severe||
0628|151|P|headaches/migraines, heart problems (such as heart valve disease,||
0628|152|P|irregular heartbeat, previous heart attack), history of yellowing||
0628|153|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
0628|154|P|birth control (such as pills, patch), kidney disease, liver||
0628|155|P|disease (including tumors), obesity, stroke, swelling (edema),||
0628|156|P|thyroid problems, unexplained vaginal bleeding.||
0628|157|P|   If you have diabetes, this medication may affect your blood||
0628|158|P|sugar. Check your blood sugar regularly as directed and share the||
0628|159|P|results with your doctor. Tell your doctor right away if you have||
0628|160|P|symptoms of high blood sugar such as increased thirst/urination.||
0628|161|P|Your doctor may need to adjust your diabetes medication, exercise||
0628|162|P|program, or diet.||
0628|163|P|   Tell your doctor if you just had or will be having surgery or||
0628|164|P|if you will be confined to a bed or chair for a long time (such||
0628|165|P|as a long plane flight). These conditions increase your risk of||
0628|166|P|getting blood clots, especially if you are using hormonal birth||
0628|167|P|control. You may need to stop this medication for a time or take||
0628|168|P|special precautions.||
0628|169|P|   Before having surgery, tell your doctor or dentist about all||
0628|170|P|the products you use (including prescription drugs,||
0628|171|P|nonprescription drugs, and herbal products).||
0628|172|P|   This medication may cause blotchy, dark areas on your face and||
0628|173|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0628|174|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0628|175|P|wear protective clothing when outdoors.||
0628|176|P|   If you are nearsighted or wear contact lenses, you may develop||
0628|177|P|vision problems or trouble wearing your contact lenses. Contact||
0628|178|P|your eye doctor if these problems occur.||
0628|179|P|   It may take longer for you to become pregnant after you stop||
0628|180|P|taking birth control pills. Consult your doctor.||
0628|181|P|   This medication should not be used during pregnancy. If you||
0628|182|P|become pregnant or think you may be pregnant, tell your doctor||
0628|183|P|right away. If you have just given birth or had a pregnancy||
0628|184|P|loss/abortion after the first 3 months, talk with your doctor||
0628|185|P|about reliable forms of birth control, and find out when it is||
0628|186|P|safe to start using birth control that contains a form of||
0628|187|P|estrogen, such as this medication.||
0628|188|P|   A small amount of this medication passes into breast milk and||
0628|189|P|may have undesirable effects on a nursing infant. Consult your||
0628|190|P|doctor before breastfeeding.||
0628|191|B|||
0628|192|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0628|193|I|medications work or increase your risk for serious side effects.||
0628|194|I|This document does not contain all possible drug interactions.||
0628|195|I|Keep a list of all the products you use (including||
0628|196|I|prescription/nonprescription drugs and herbal products) and share||
0628|197|I|it with your doctor and pharmacist. Do not start, stop, or change||
0628|198|I|the dosage of any medicines without your doctor's approval.||
0628|199|I|   Some products that may interact with this drug include:||
0628|200|I|aromatase inhibitors (such as anastrozole, exemestane),||
0628|201|I|fezolinetant, ospemifene, tamoxifen, tizanidine, tranexamic acid.||
0628|202|I|   Some drugs may cause hormonal birth control to work less well||
0628|203|I|by decreasing the amount of birth control hormones in your body.||
0628|204|I|This effect can result in pregnancy. Examples include||
0628|205|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
0628|206|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
0628|207|I|seizures (such as barbiturates, carbamazepine, felbamate,||
0628|208|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
0628|209|I|nevirapine), among others.||
0628|210|I|   Tell your doctor when you start any new drug, and discuss if||
0628|211|I|you should use reliable backup birth control. Also tell your||
0628|212|I|doctor if you have any new spotting or breakthrough bleeding,||
0628|213|I|because these may be signs that your birth control is not working||
0628|214|I|well.||
0628|215|I|   This medication may interfere with certain lab tests (such as||
0628|216|I|blood clotting factors, thyroid), possibly causing false test||
0628|217|I|results. Make sure lab personnel and all your doctors know you||
0628|218|I|use this drug.||
0628|219|B|||
0628|220|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0628|221|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0628|222|O|poison control center right away. US residents can call||
0628|223|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0628|224|O|Symptoms of overdose may include severe nausea and vomiting,||
0628|225|O|sudden/unusual vaginal bleeding.||
0628|226|B|||
0628|227|N|NOTES:  Do not share this medication with others.||
0628|228|N|   Regular complete physical exams which include lab and/or||
0628|229|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
0628|230|N|Pap smear) should be done while you are taking this medication.||
0628|231|N|Follow your doctor's instructions for examining your breasts, and||
0628|232|N|report any lumps right away. Keep all medical and lab||
0628|233|N|appointments. Consult your doctor for more details.||
0628|234|B|||
0628|235|D|MISSED DOSE:  Refer to the product package information for advice||
0628|236|D|on missed doses. You may need to use backup birth control (such||
0628|237|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
0628|238|D|pharmacist if you have any questions.||
0628|239|D|   If you often forget to take your pills as directed, contact||
0628|240|D|your doctor to discuss switching to another form of birth||
0628|241|D|control.||
0628|242|B|||
0628|243|R|STORAGE:  Store at room temperature away from light and moisture.||
0628|244|R|Do not store in the bathroom. Keep all medications away from||
0628|245|R|children and pets.||
0628|246|R|   Do not flush medications down the toilet or pour them into a||
0628|247|R|drain unless instructed to do so. Properly discard this product||
0628|248|R|when it is expired or no longer needed. Consult your pharmacist||
0628|249|R|or local waste disposal company.||
0628|250|B|||
0628|251|A|Information last revised October 2025.||
0628|252|A|Copyright(c) 2025 First Databank, Inc.||
0628|253|B|||
0629|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0629|002|Z|does NOT have all possible information about this product. This||
0629|003|Z|information does not assure that this product is safe, effective,||
0629|004|Z|or appropriate for you. This information is not individual||
0629|005|Z|medical advice and does not substitute for the advice of your||
0629|006|Z|health care professional. Always ask your health care||
0629|007|Z|professional for complete information about this product and your||
0629|008|Z|specific health needs.||
0629|009|B|||
0629|010|T|DICLOFENAC SODIUM SUSTAINED-ACTION TABLET - ORAL||
0629|011|F|(dye-KLOE-fen-ack SOE-dee-um)||
0629|012|B|||
0629|013|C|COMMON BRAND NAME(S): Voltaren-XR||
0629|014|B|||
0629|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0629|016|W|diclofenac) may rarely increase the risk of a heart attack or||
0629|017|W|stroke. This effect can happen at any time while taking this drug||
0629|018|W|but is more likely if you take it for a long time. The risk may||
0629|019|W|be greater in older adults or if you have heart disease or||
0629|020|W|increased risk for heart disease (for example, due to smoking,||
0629|021|W|family history of heart disease, or conditions such as high blood||
0629|022|W|pressure or diabetes). Do not take this drug right before or||
0629|023|W|after heart bypass surgery (CABG).||
0629|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0629|025|W|bleeding from the stomach or intestines. This effect can occur||
0629|026|W|without warning symptoms at any time while taking this drug.||
0629|027|W|Older adults may be at higher risk for this effect.||
0629|028|W|   Stop taking diclofenac and get medical help right away if you||
0629|029|W|notice any of these rare but serious side effects:||
0629|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0629|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0629|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0629|033|W|side of the body, trouble speaking, sudden vision changes.||
0629|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0629|035|W|of taking this drug.||
0629|036|B|||
0629|037|U|USES:  See also Warning section.||
0629|038|U|   The sustained-action tablet form of diclofenac is used to||
0629|039|U|reduce pain, swelling (inflammation), and joint stiffness from||
0629|040|U|arthritis. Reducing these symptoms helps you do more of your||
0629|041|U|normal daily activities.||
0629|042|U|   Diclofenac is known as a nonsteroidal anti-inflammatory drug||
0629|043|U|(NSAID). It works by blocking your body's production of certain||
0629|044|U|natural substances that cause inflammation. This effect helps to||
0629|045|U|decrease swelling, pain, or fever.||
0629|046|U|   Ask your doctor about non-drug treatments and/or using other||
0629|047|U|medications to treat your pain.||
0629|048|B|||
0629|049|V|OTHER USES:  This section contains uses of this drug that are not||
0629|050|V|listed in the approved professional labeling for the drug but||
0629|051|V|that may be prescribed by your health care professional. Use this||
0629|052|V|drug for a condition that is listed in this section only if it||
0629|053|V|has been so prescribed by your health care professional.||
0629|054|V|   This medication may also be used for gout, bursitis, or||
0629|055|V|tendonitis.||
0629|056|B|||
0629|057|H|HOW TO USE:  Read the Medication Guide provided by your||
0629|058|H|pharmacist before you start taking diclofenac and each time you||
0629|059|H|get a refill. If you have any questions, ask your doctor or||
0629|060|H|pharmacist.||
0629|061|H|   Take this medication by mouth as directed by your doctor,||
0629|062|H|usually once daily. Take this medication with a full glass of||
0629|063|H|water (8 ounces/240 milliliters) unless your doctor directs you||
0629|064|H|otherwise. Do not lie down for at least 10 minutes after taking||
0629|065|H|this medication. If stomach upset occurs while taking this||
0629|066|H|medication, take it with food, milk, or an antacid.||
0629|067|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
0629|068|H|Doing so can release all of the drug at once, increasing the risk||
0629|069|H|of side effects.||
0629|070|H|   There are different brands and forms of this medication||
0629|071|H|available. Because different forms do not have the same effects||
0629|072|H|at equal strengths, do not switch forms of diclofenac unless your||
0629|073|H|doctor tells you to.||
0629|074|H|   The dosage is based on your medical condition, response to||
0629|075|H|treatment, and other medications you may be taking. To reduce||
0629|076|H|your risk of stomach bleeding and other side effects, take this||
0629|077|H|medication at the lowest effective dose for the shortest possible||
0629|078|H|time. Do not increase your dose or take this drug more often or||
0629|079|H|for longer than prescribed. Discuss the risks and benefits with||
0629|080|H|your doctor or pharmacist.||
0629|081|H|   For certain conditions (such as arthritis), it may take up to||
0629|082|H|2 weeks of taking this drug regularly until you get the full||
0629|083|H|benefit.||
0629|084|H|   Tell your doctor if your condition gets worse.||
0629|085|B|||
0629|086|S|SIDE EFFECTS:  See also Warning section.||
0629|087|S|   Upset stomach, nausea, heartburn, diarrhea, constipation, gas,||
0629|088|S|headache, drowsiness, dizziness, or blurred vision may occur. If||
0629|089|S|any of these effects last or get worse, tell your doctor or||
0629|090|S|pharmacist promptly.||
0629|091|S|   Remember that this medication has been prescribed because your||
0629|092|S|doctor has judged that the benefit to you is greater than the||
0629|093|S|risk of side effects. Many people using this medication do not||
0629|094|S|have serious side effects.||
0629|095|S|   This medication may raise your blood pressure. Check your||
0629|096|S|blood pressure regularly and tell your doctor if the results are||
0629|097|S|high.||
0629|098|S|   Tell your doctor right away if you have any serious side||
0629|099|S|effects, including: hearing changes (such as ringing in the||
0629|100|S|ears), mental/mood changes, easy bleeding/bruising,||
0629|101|S|difficult/painful swallowing, signs of kidney problems (such as||
0629|102|S|change in the amount of urine, pink/bloody urine), symptoms of||
0629|103|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
0629|104|S|unusual/sudden weight gain).||
0629|105|S|   Diclofenac may rarely cause serious (possibly fatal) liver||
0629|106|S|disease. Get medical help right away if you have any symptoms of||
0629|107|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0629|108|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0629|109|S|urine.||
0629|110|S|   A very serious allergic reaction to this drug is rare.||
0629|111|S|However, get medical help right away if you notice any symptoms||
0629|112|S|of a serious allergic reaction, including: fever, swollen lymph||
0629|113|S|nodes, rash, itching/swelling (especially of the||
0629|114|S|face/tongue/throat), severe dizziness, trouble breathing.||
0629|115|S|   This is not a complete list of possible side effects. If you||
0629|116|S|notice other effects not listed above, contact your doctor or||
0629|117|S|pharmacist.||
0629|118|S|   In the US -||
0629|119|S|   Call your doctor for medical advice about side effects. You||
0629|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0629|121|S|www.fda.gov/medwatch.||
0629|122|S|   In Canada - Call your doctor for medical advice about side||
0629|123|S|effects. You may report side effects to Health Canada at||
0629|124|S|1-866-234-2345.||
0629|125|B|||
0629|126|P|PRECAUTIONS:  See also Warning section.||
0629|127|P|   Before taking diclofenac, tell your doctor or pharmacist if||
0629|128|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
0629|129|P|ibuprofen, naproxen, celecoxib); or if you have any other||
0629|130|P|allergies. This product may contain inactive ingredients, which||
0629|131|P|can cause allergic reactions or other problems. Talk to your||
0629|132|P|pharmacist for more details.||
0629|133|P|   Before using this medication, tell your doctor or pharmacist||
0629|134|P|your medical history, especially of: asthma (including a history||
0629|135|P|of worsening breathing after taking aspirin or other NSAIDs),||
0629|136|P|blood disorders (such as anemia, bleeding/clotting problems),||
0629|137|P|growths in the nose (nasal polyps), heart disease (such as||
0629|138|P|previous heart attack), high blood pressure, liver disease,||
0629|139|P|stroke, swelling (edema, fluid retention),||
0629|140|P|stomach/intestinal/esophagus problems (such as bleeding,||
0629|141|P|heartburn, ulcers).||
0629|142|P|   Kidney problems can sometimes occur with the use of NSAID||
0629|143|P|medications, including diclofenac. Problems are more likely to||
0629|144|P|occur if you are dehydrated, have heart failure or kidney||
0629|145|P|disease, are an older adult, or if you take certain medications||
0629|146|P|(see also Drug Interactions section). Drink plenty of fluids as||
0629|147|P|directed by your doctor to prevent dehydration and tell your||
0629|148|P|doctor right away if you have pink/bloody urine or any unusual||
0629|149|P|change in the amount of urine.||
0629|150|P|   This drug may make you dizzy or drowsy or cause blurred||
0629|151|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
0629|152|P|Do not drive, use machinery, or do anything that needs alertness||
0629|153|P|or clear vision until you can do it safely. Limit alcoholic||
0629|154|P|beverages. Talk to your doctor if you are using marijuana||
0629|155|P|(cannabis).||
0629|156|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0629|157|P|and tobacco, especially when combined with this medicine, may||
0629|158|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0629|159|P|smoking.||
0629|160|P|   This medication may make you more sensitive to the sun. Limit||
0629|161|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0629|162|P|sunscreen and wear protective clothing when outdoors. Tell your||
0629|163|P|doctor right away if you get sunburned or have skin||
0629|164|P|blisters/redness.||
0629|165|P|   Before having surgery, tell your doctor or dentist about all||
0629|166|P|the products you use (including prescription drugs,||
0629|167|P|nonprescription drugs, and herbal products).||
0629|168|P|   Older adults may be at greater risk for stomach/intestinal||
0629|169|P|bleeding, kidney problems, heart attack, and stroke while using||
0629|170|P|this drug.||
0629|171|P|   Before using this medication, women of childbearing age should||
0629|172|P|talk with their doctor(s) about the benefits and risks. Tell your||
0629|173|P|doctor if you are pregnant or if you plan to become pregnant.||
0629|174|P|This medication may harm an unborn baby and cause problems with||
0629|175|P|normal labor/delivery. It is not recommended for use in pregnancy||
0629|176|P|from 20 weeks until delivery. If your doctor decides that you||
0629|177|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0629|178|P|you should use the lowest effective dose for the shortest||
0629|179|P|possible time. You should not use this medication after 30 weeks||
0629|180|P|of pregnancy.||
0629|181|P|   This medication passes into breast milk. Consult your doctor||
0629|182|P|before breastfeeding.||
0629|183|B|||
0629|184|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0629|185|I|medications work or increase your risk for serious side effects.||
0629|186|I|This document does not contain all possible drug interactions.||
0629|187|I|Keep a list of all the products you use (including||
0629|188|I|prescription/nonprescription drugs and herbal products) and share||
0629|189|I|it with your doctor and pharmacist. Do not start, stop, or change||
0629|190|I|the dosage of any medicines without your doctor's approval.||
0629|191|I|   Some products that may interact with this drug are: aliskiren,||
0629|192|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
0629|193|I|receptor blockers (such as losartan, valsartan), cidofovir,||
0629|194|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
0629|195|I|methotrexate, "water pills" (diuretics such as furosemide).||
0629|196|I|   This medication may increase the risk of bleeding when taken||
0629|197|I|with other drugs that also may cause bleeding. Examples include||
0629|198|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0629|199|I|dabigatran/enoxaparin/warfarin, among others.||
0629|200|I|   Check all prescription and nonprescription medicine labels||
0629|201|I|carefully since many medications contain pain relievers/fever||
0629|202|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
0629|203|I|naproxen). These drugs are similar to diclofenac and may increase||
0629|204|I|your risk of side effects if taken together. However, if your||
0629|205|I|doctor has told you to take low-dose aspirin to prevent heart||
0629|206|I|attack or stroke (usually 81-162 milligrams a day), you should||
0629|207|I|keep taking the aspirin unless your doctor tells you not to. Ask||
0629|208|I|your doctor or pharmacist for more details.||
0629|209|B|||
0629|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0629|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0629|212|O|poison control center right away. US residents can call||
0629|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0629|214|O|Symptoms of overdose may include: severe stomach pain,||
0629|215|O|slow/shallow breathing, extreme drowsiness.||
0629|216|B|||
0629|217|N|NOTES:  Do not share this medication with others.||
0629|218|N|   Lab and/or medical tests (such as complete blood count,||
0629|219|N|liver/kidney function, blood pressure) may be done while you are||
0629|220|N|using this medication. Keep all medical and lab appointments.||
0629|221|N|Consult your doctor for more details.||
0629|222|N|   Lifestyle changes (such as weight loss if needed,||
0629|223|N|strengthening/conditioning exercises) may help improve your||
0629|224|N|flexibility and joint function. Consult your doctor for specific||
0629|225|N|instructions.||
0629|226|B|||
0629|227|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0629|228|D|remember. If it is near the time of the next dose, skip the||
0629|229|D|missed dose. Take your next dose at the regular time. Do not||
0629|230|D|double the dose to catch up.||
0629|231|B|||
0629|232|R|STORAGE:  Store at room temperature away from light and moisture.||
0629|233|R|Do not store in the bathroom. Keep all medications away from||
0629|234|R|children and pets.||
0629|235|R|   Do not flush medications down the toilet or pour them into a||
0629|236|R|drain unless instructed to do so. Properly discard this product||
0629|237|R|when it is expired or no longer needed. Consult your pharmacist||
0629|238|R|or local waste disposal company.||
0629|239|B|||
0629|240|A|Information last revised September 2024.||
0629|241|A|Copyright(c) 2025 First Databank, Inc.||
0629|242|B|||
0630|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0630|002|Z|does NOT have all possible information about this product. This||
0630|003|Z|information does not assure that this product is safe, effective,||
0630|004|Z|or appropriate for you. This information is not individual||
0630|005|Z|medical advice and does not substitute for the advice of your||
0630|006|Z|health care professional. Always ask your health care||
0630|007|Z|professional for complete information about this product and your||
0630|008|Z|specific health needs.||
0630|009|B|||
0630|010|T|GUAIFENESIN SUSTAINED-RELEASE - ORAL||
0630|011|F|(gweye-FEN-eh-sin)||
0630|012|B|||
0630|013|C|COMMON BRAND NAME(S): Allfen, Mucinex, Numobid||
0630|014|B|||
0630|015|U|USES:  This medication is used for the temporary relief of coughs||
0630|016|U|caused by the common cold, bronchitis, and other breathing||
0630|017|U|illnesses. This product is usually not used for ongoing cough||
0630|018|U|from smoking or long-term breathing problems (such as chronic||
0630|019|U|bronchitis, emphysema) unless directed by your doctor.||
0630|020|U|Guaifenesin is an expectorant. It works by thinning and loosening||
0630|021|U|mucus in the airways, clearing congestion, and making breathing||
0630|022|U|easier.||
0630|023|U|   If you are self-treating with this medication, it is important||
0630|024|U|to read the package instructions carefully before you start using||
0630|025|U|this product to be sure it is right for you. (See also||
0630|026|U|Precautions section.)||
0630|027|U|   Cough-and-cold products have not been shown to be safe or||
0630|028|U|effective in children younger than 6 years. This product||
0630|029|U|(sustained-release) is not recommended for use in children||
0630|030|U|younger than 12 years unless specifically directed by the doctor.||
0630|031|U|Ask your doctor or pharmacist for more details about using your||
0630|032|U|product safely.||
0630|033|U|   These products do not cure or shorten the length of the common||
0630|034|U|cold. To decrease the risk for side effects, carefully follow all||
0630|035|U|dosage directions. Do not give other cough-and-cold medication||
0630|036|U|that might contain the same or similar ingredients (see also Drug||
0630|037|U|Interactions section). Ask the doctor or pharmacist about other||
0630|038|U|ways to relieve cough and cold symptoms (such as drinking enough||
0630|039|U|fluids, using a humidifier or saline nose drops/spray).||
0630|040|B|||
0630|041|H|HOW TO USE:  Take this medication by mouth with or without food,||
0630|042|H|as directed by your doctor, usually every 12 hours with a full||
0630|043|H|glass of water. If you are self-treating, follow all directions||
0630|044|H|on the product package. If you have any questions, ask your||
0630|045|H|doctor or pharmacist.||
0630|046|H|   Dosage is based on your age, medical condition, and response||
0630|047|H|to treatment. Do not take more than 2400 milligrams in 24 hours.||
0630|048|H|Do not increase your dose or take this drug more often than||
0630|049|H|directed.||
0630|050|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
0630|051|H|Doing so can release all of the drug at once, increasing the risk||
0630|052|H|of side effects.||
0630|053|H|   Drink plenty of fluids while taking this medication. Fluids||
0630|054|H|will help to break up mucus and clear congestion.||
0630|055|H|   Tell your doctor if your condition returns, or if it is||
0630|056|H|accompanied by a headache that doesn't go away, fever, severe||
0630|057|H|sore throat, rash, or if it lasts or gets worse after 7 days.||
0630|058|H|These may be signs of a serious medical problem. Get medical help||
0630|059|H|right away if you think you may have a serious medical problem.||
0630|060|B|||
0630|061|S|SIDE EFFECTS:  Nausea or vomiting may occur. If either of these||
0630|062|S|effects last or get worse, tell your doctor or pharmacist||
0630|063|S|promptly.||
0630|064|S|   If your doctor has directed you to use this medication,||
0630|065|S|remember that your doctor has judged that the benefit to you is||
0630|066|S|greater than the risk of side effects. Many people using this||
0630|067|S|medication do not have serious side effects.||
0630|068|S|   A very serious allergic reaction to this drug is rare.||
0630|069|S|However, get medical help right away if you notice any symptoms||
0630|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0630|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0630|072|S|breathing.||
0630|073|S|   This is not a complete list of possible side effects. If you||
0630|074|S|notice other effects not listed above, contact your doctor or||
0630|075|S|pharmacist.||
0630|076|S|   In the US -||
0630|077|S|   Call your doctor for medical advice about side effects. You||
0630|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0630|079|S|www.fda.gov/medwatch.||
0630|080|S|   In Canada - Call your doctor for medical advice about side||
0630|081|S|effects. You may report side effects to Health Canada at||
0630|082|S|1-866-234-2345.||
0630|083|B|||
0630|084|P|PRECAUTIONS:  Before taking guaifenesin, tell your doctor or||
0630|085|P|pharmacist if you are allergic to it; or if you have any other||
0630|086|P|allergies. This product may contain inactive ingredients, which||
0630|087|P|can cause allergic reactions or other problems. Talk to your||
0630|088|P|pharmacist for more details.||
0630|089|P|   Before using this medication, tell your doctor or pharmacist||
0630|090|P|your medical history, especially of: breathing problems (such as||
0630|091|P|emphysema, chronic bronchitis, asthma, smoker's cough), cough||
0630|092|P|with blood or large amounts of mucus.||
0630|093|P|   Before having surgery, tell your doctor or dentist about all||
0630|094|P|the products you use (including prescription drugs,||
0630|095|P|nonprescription drugs, and herbal products).||
0630|096|P|   During pregnancy, this medication should be used only when||
0630|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
0630|098|P|   It is unknown if guaifenesin passes into breast milk. Consult||
0630|099|P|your doctor before breastfeeding.||
0630|100|B|||
0630|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0630|102|I|medications work or increase your risk for serious side effects.||
0630|103|I|This document does not contain all possible drug interactions.||
0630|104|I|Keep a list of all the products you use (including||
0630|105|I|prescription/nonprescription drugs and herbal products) and share||
0630|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
0630|107|I|the dosage of any medicines without your doctor's approval.||
0630|108|I|   Guaifenesin is available in both prescription and||
0630|109|I|nonprescription products. Check the labels of all your||
0630|110|I|medications to make sure you are not taking more than one product||
0630|111|I|containing guaifenesin.||
0630|112|I|   This medication may interfere with certain lab tests (such as||
0630|113|I|urine levels of certain acids), possibly causing false test||
0630|114|I|results. Make sure lab personnel and all your doctors know you||
0630|115|I|use this drug.||
0630|116|B|||
0630|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0630|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0630|119|O|poison control center right away. US residents can call||
0630|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0630|121|B|||
0630|122|N|NOTES:  If your doctor prescribed this medication, do not share||
0630|123|N|this medication with others.||
0630|124|N|   Keep all medical and lab appointments.||
0630|125|B|||
0630|126|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0630|127|D|remember. If it is near the time of the next dose, skip the||
0630|128|D|missed dose. Take your next dose at the regular time. Do not||
0630|129|D|double the dose to catch up.||
0630|130|B|||
0630|131|R|STORAGE:  Store at room temperature away from light and moisture.||
0630|132|R|Do not store in the bathroom. Keep all medications away from||
0630|133|R|children and pets.||
0630|134|R|   Do not flush medications down the toilet or pour them into a||
0630|135|R|drain unless instructed to do so. Properly discard this product||
0630|136|R|when it is expired or no longer needed. Consult your pharmacist||
0630|137|R|or local waste disposal company.||
0630|138|B|||
0630|139|A|Information last revised May 2024.||
0630|140|A|Copyright(c) 2025 First Databank, Inc.||
0630|141|B|||
0631|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0631|002|Z|does NOT have all possible information about this product. This||
0631|003|Z|information does not assure that this product is safe, effective,||
0631|004|Z|or appropriate for you. This information is not individual||
0631|005|Z|medical advice and does not substitute for the advice of your||
0631|006|Z|health care professional. Always ask your health care||
0631|007|Z|professional for complete information about this product and your||
0631|008|Z|specific health needs.||
0631|009|B|||
0631|010|T|GUAIFENESIN/PSEUDOEPHEDRINE SUSTAINED-RELEASE - ORAL||
0631|011|F|(gweye-FEN-eh-sin/sue-doh-eff-ED-rin)||
0631|012|B|||
0631|013|C|COMMON BRAND NAME(S): Mucinex D||
0631|014|B|||
0631|015|U|USES:  This combination medication is used to temporarily treat||
0631|016|U|cough and runny/stuffy nose (nasal congestion) caused by||
0631|017|U|infections (such as the common cold), allergies (such as hay||
0631|018|U|fever), and other breathing illnesses. This product is usually||
0631|019|U|not used for ongoing cough from smoking or long-term breathing||
0631|020|U|problems (such as chronic bronchitis, emphysema) unless directed||
0631|021|U|by your doctor. Guaifenesin is an expectorant. It works by||
0631|022|U|thinning and loosening mucus in the airways, clearing congestion,||
0631|023|U|and making breathing easier. Pseudoephedrine is a decongestant||
0631|024|U|(sympathomimetic). It reduces nasal congestion by narrowing the||
0631|025|U|blood vessels in the nose.||
0631|026|U|   If you are self-treating with this medication, it is important||
0631|027|U|to read the package instructions carefully before you start using||
0631|028|U|this product to be sure it is right for you. (See also||
0631|029|U|Precautions section.)||
0631|030|U|   Cough-and-cold products have not been shown to be safe or||
0631|031|U|effective in children younger than 6 years. Do not use this||
0631|032|U|product to treat cold symptoms in children younger than 6 years||
0631|033|U|unless specifically directed by the doctor. Some long-acting||
0631|034|U|products are not recommended for use in children younger than 12||
0631|035|U|years. Ask your doctor or pharmacist for more details about using||
0631|036|U|your product safely.||
0631|037|U|   These products do not cure or shorten the length of the common||
0631|038|U|cold and may cause serious side effects. To decrease the risk for||
0631|039|U|serious side effects, carefully follow all dosage directions. Do||
0631|040|U|not give other cough-and-cold medication that might contain the||
0631|041|U|same or similar ingredients (see also Drug Interactions section).||
0631|042|U|Ask the doctor or pharmacist about other ways to relieve cough||
0631|043|U|and cold symptoms (such as drinking enough fluids, using a||
0631|044|U|humidifier or saline nose drops/spray).||
0631|045|B|||
0631|046|H|HOW TO USE:  Take this medication by mouth with or without food,||
0631|047|H|usually every 12 hours with a full glass of water or as directed||
0631|048|H|by your doctor. If stomach upset occurs, take with food or milk.||
0631|049|H|If you are self-treating, follow all directions on the product||
0631|050|H|package. To prevent trouble sleeping, do not take this medication||
0631|051|H|close to bedtime. If you have any questions, ask your doctor or||
0631|052|H|pharmacist.||
0631|053|H|   Swallow the capsules whole and do not open them. Do not crush||
0631|054|H|or chew the capsules or tablets. Doing so can release all of the||
0631|055|H|drug at once, increasing the risk of side effects. Also, do not||
0631|056|H|split the tablets unless they have a score line and your doctor||
0631|057|H|or pharmacist tells you to do so. Swallow the whole or split||
0631|058|H|tablet without crushing or chewing.||
0631|059|H|   The dosage is based on your age, medical condition, and||
0631|060|H|response to treatment. Do not take more than 2 doses in a day. Do||
0631|061|H|not increase your dose or take this drug more often than||
0631|062|H|directed.||
0631|063|H|   Drink plenty of fluids while taking this medication. Fluids||
0631|064|H|will help to break up mucus and clear congestion.||
0631|065|H|   Caffeine can increase the side effects of this medication.||
0631|066|H|Avoid drinking large amounts of beverages containing caffeine||
0631|067|H|(coffee, tea, colas), eating large amounts of chocolate, or||
0631|068|H|taking nonprescription products that contain caffeine.||
0631|069|H|   Tell your doctor if your condition is accompanied by a||
0631|070|H|headache that doesn't go away, fever, severe sore throat, rash,||
0631|071|H|or if it lasts, returns, or gets worse after 7 days. These may be||
0631|072|H|signs of a serious medical problem. Get medical help right away||
0631|073|H|if you think you may have a serious medical problem.||
0631|074|B|||
0631|075|S|SIDE EFFECTS:  Nausea or headache may occur. If either of these||
0631|076|S|effects last or get worse, tell your doctor or pharmacist||
0631|077|S|promptly.||
0631|078|S|   If your doctor has directed you to use this medication,||
0631|079|S|remember that your doctor has judged that the benefit to you is||
0631|080|S|greater than the risk of side effects. Many people using this||
0631|081|S|medication do not have serious side effects.||
0631|082|S|   This medication may raise your blood pressure. Check your||
0631|083|S|blood pressure regularly and tell your doctor if the results are||
0631|084|S|high.||
0631|085|S|   Tell your doctor right away if you have any serious side||
0631|086|S|effects, including: dizziness, fainting, fast/irregular/pounding||
0631|087|S|heartbeat, mental/mood changes (such as anxiety, confusion,||
0631|088|S|nervousness, irritability), shaking (tremor), trouble sleeping,||
0631|089|S|difficult/painful urination.||
0631|090|S|   A very serious allergic reaction to this drug is rare.||
0631|091|S|However, get medical help right away if you notice any symptoms||
0631|092|S|of a serious allergic reaction, including: rash, itching/swelling||
0631|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0631|094|S|breathing.||
0631|095|S|   This is not a complete list of possible side effects. If you||
0631|096|S|notice other effects not listed above, contact your doctor or||
0631|097|S|pharmacist.||
0631|098|S|   In the US -||
0631|099|S|   Call your doctor for medical advice about side effects. You||
0631|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0631|101|S|www.fda.gov/medwatch.||
0631|102|S|   In Canada - Call your doctor for medical advice about side||
0631|103|S|effects. You may report side effects to Health Canada at||
0631|104|S|1-866-234-2345.||
0631|105|B|||
0631|106|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0631|107|P|pharmacist if you are allergic to pseudoephedrine or guaifenesin;||
0631|108|P|or if you have any other allergies. Also tell your doctor if you||
0631|109|P|have had a bad reaction to similar drugs (sympathomimetics such||
0631|110|P|as ephedrine, phenylephrine). This product may contain inactive||
0631|111|P|ingredients, which can cause allergic reactions or other||
0631|112|P|problems. Talk to your pharmacist for more details.||
0631|113|P|   Before using this medication, tell your doctor or pharmacist||
0631|114|P|your medical history, especially of: breathing problems (such as||
0631|115|P|emphysema, chronic bronchitis, asthma, smoker's cough), cough||
0631|116|P|with blood or large amounts of mucus, high blood pressure, heart||
0631|117|P|disease (such as chest pain, heart failure, heart attack),||
0631|118|P|fast/slow/irregular heartbeat, diabetes, a certain eye problem||
0631|119|P|(glaucoma), kidney problems, difficulty urinating (such as due to||
0631|120|P|enlarged prostate), overactive thyroid (hyperthyroidism).||
0631|121|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0631|122|P|can make you more dizzy. Do not drive, use machinery, or do||
0631|123|P|anything that needs alertness until you can do it safely. Limit||
0631|124|P|alcoholic beverages. Talk to your doctor if you are using||
0631|125|P|marijuana (cannabis).||
0631|126|P|   Before having surgery, tell your doctor or dentist about all||
0631|127|P|the products you use (including prescription drugs,||
0631|128|P|nonprescription drugs, and herbal products).||
0631|129|P|   Children may be more sensitive to the side effects of this||
0631|130|P|drug, especially nervousness, irritability, and high blood||
0631|131|P|pressure.||
0631|132|P|   Older adults may be more sensitive to the side effects of this||
0631|133|P|drug, especially fast/irregular heartbeat, dizziness, problems||
0631|134|P|urinating, trouble sleeping, or confusion.||
0631|135|P|   During pregnancy, this medication should be used only when||
0631|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
0631|137|P|   Pseudoephedrine passes into breast milk. It is unknown if||
0631|138|P|guaifenesin passes into breast milk. Consult your doctor before||
0631|139|P|breastfeeding.||
0631|140|B|||
0631|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0631|142|I|medications work or increase your risk for serious side effects.||
0631|143|I|This document does not contain all possible drug interactions.||
0631|144|I|Keep a list of all the products you use (including||
0631|145|I|prescription/nonprescription drugs and herbal products) and share||
0631|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
0631|147|I|the dosage of any medicines without your doctor's approval.||
0631|148|I|   Taking MAO inhibitors with this medication may cause a serious||
0631|149|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0631|150|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0631|151|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0631|152|I|selegiline, tranylcypromine) during treatment with this||
0631|153|I|medication. Most MAO inhibitors should also not be taken for two||
0631|154|I|weeks before treatment with this medication. Ask your doctor when||
0631|155|I|to start or stop taking this medication.||
0631|156|I|   Pseudoephedrine and guaifenesin are available in both||
0631|157|I|prescription and nonprescription products. Check the labels of||
0631|158|I|all your medications carefully to make sure you are not taking||
0631|159|I|more than one product containing these medications.||
0631|160|I|   This medication may interfere with certain lab tests (such as||
0631|161|I|urine levels of certain acids), possibly causing false test||
0631|162|I|results. Make sure lab personnel and all your doctors know you||
0631|163|I|use this drug.||
0631|164|B|||
0631|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0631|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0631|167|O|poison control center right away. US residents can call||
0631|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0631|169|O|Symptoms of overdose may include: severe dizziness/fainting, fast||
0631|170|O|irregular heartbeat, slow/fast/shallow breathing, hallucinations,||
0631|171|O|seizures.||
0631|172|B|||
0631|173|N|NOTES:  If your doctor prescribed this medication, do not share||
0631|174|N|this medication with others.||
0631|175|N|   Keep all medical and lab appointments.||
0631|176|B|||
0631|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0631|178|D|remember. If it is near the time of the next dose, skip the||
0631|179|D|missed dose. Take your next dose at the regular time. Do not||
0631|180|D|double the dose to catch up.||
0631|181|B|||
0631|182|R|STORAGE:  Store at room temperature away from light and moisture.||
0631|183|R|Do not store in the bathroom. Different brands of this medication||
0631|184|R|have different storage needs. Check the product package for||
0631|185|R|instructions on how to store your brand, or ask your pharmacist.||
0631|186|R|Keep all medications away from children and pets.||
0631|187|R|   Do not flush medications down the toilet or pour them into a||
0631|188|R|drain unless instructed to do so. Properly discard this product||
0631|189|R|when it is expired or no longer needed. Consult your pharmacist||
0631|190|R|or local waste disposal company.||
0631|191|B|||
0631|192|A|Information last revised July 2025.||
0631|193|A|Copyright(c) 2025 First Databank, Inc.||
0631|194|B|||
0632|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0632|002|Z|does NOT have all possible information about this product. This||
0632|003|Z|information does not assure that this product is safe, effective,||
0632|004|Z|or appropriate for you. This information is not individual||
0632|005|Z|medical advice and does not substitute for the advice of your||
0632|006|Z|health care professional. Always ask your health care||
0632|007|Z|professional for complete information about this product and your||
0632|008|Z|specific health needs.||
0632|009|B|||
0632|010|T|NORETHINDRONE/ETHINYL ESTRADIOL/FERROUS FUMARATE 24/4 - ORAL||
0632|011|F|(nor-ETH-in-drone/ETH-i-nil ES-tra-DYE-ol/FER-us FUE-ma-rate)||
0632|012|B|||
0632|013|C|COMMON BRAND NAME(S): Generess Fe, Loestrin 24 Fe, Minastrin 24 Fe||
0632|014|B|||
0632|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
0632|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
0632|017|W|stroke, heart attack, blood clots, and high blood pressure from||
0632|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
0632|019|W|of these serious problems increases with age and with the number||
0632|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
0632|021|W|   Accidental overdose of iron-containing products is a leading||
0632|022|W|cause of fatal poisoning in children younger than 6 years. Keep||
0632|023|W|this product out of reach of children. If overdose does occur,||
0632|024|W|get medical help right away or call a poison control center.||
0632|025|B|||
0632|026|U|USES:  This combination hormone medication is used to prevent||
0632|027|U|pregnancy. It contains 2 hormones: norethindrone (a progestin)||
0632|028|U|and ethinyl estradiol (an estrogen). There is a small amount of||
0632|029|U|iron (ferrous fumarate) in each of the 4 inactive pills taken||
0632|030|U|during the fourth week. The inactive pills do not contain any||
0632|031|U|hormones. These pills are meant to keep you in the habit of||
0632|032|U|taking 1 pill each day and do not have enough iron to treat iron||
0632|033|U|deficiency.||
0632|034|U|   Besides preventing pregnancy, birth control pills may make||
0632|035|U|your periods more regular, decrease blood loss and painful||
0632|036|U|periods, decrease your risk of ovarian cysts, and also treat||
0632|037|U|acne.||
0632|038|U|   This medication does not protect against sexually transmitted||
0632|039|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
0632|040|U|an effective barrier method (latex or polyurethane condom/dental||
0632|041|U|dams) during sexual activity will help to decrease your risk of||
0632|042|U|infection.||
0632|043|B|||
0632|044|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0632|045|H|your pharmacist before you start using this product and each time||
0632|046|H|you get a refill. The leaflet contains very important information||
0632|047|H|on when to take your pills and what to do if you miss a dose. If||
0632|048|H|you have any questions, ask your doctor or pharmacist.||
0632|049|H|   Take this medication by mouth with or without food as directed||
0632|050|H|by your doctor, usually once daily. Pick a time of day that is||
0632|051|H|easy for you to remember, and take your pill at the same time||
0632|052|H|each day.||
0632|053|H|   If you are taking the chewable pill, chew and swallow one pill||
0632|054|H|every day. Some brands may also be swallowed whole. Some brands||
0632|055|H|should be taken with water while others should be taken without||
0632|056|H|water. Carefully follow the manufacturer's directions for your||
0632|057|H|brand.||
0632|058|H|   It is very important to keep taking this medication exactly as||
0632|059|H|prescribed by your doctor. Follow the package instructions to||
0632|060|H|find the first pill, start with the first pill in the pack, and||
0632|061|H|take them in the correct order. Do not skip any doses. Pregnancy||
0632|062|H|is more likely if you miss pills, start a new pack late, or take||
0632|063|H|your pill at a different time of the day than usual.||
0632|064|H|   Taking this medication after your evening meal or at bedtime||
0632|065|H|may help if you have any stomach upset or nausea with the||
0632|066|H|medication. You may choose to take this medication at another||
0632|067|H|time of day that is easier for you to remember. No matter what||
0632|068|H|dosing schedule you use, it is very important that you take this||
0632|069|H|medication at the same time each day, 24 hours apart. Ask your||
0632|070|H|doctor or pharmacist if you have any questions.||
0632|071|H|   If you have vomiting or diarrhea within 4 hours after taking||
0632|072|H|your pill, read the Patient Information Leaflet section titled||
0632|073|H|"What to Do if You Miss Tablets/Capsules." Follow the||
0632|074|H|instructions as if you had missed your dose because||
0632|075|H|vomiting/diarrhea can stop the pill from working.||
0632|076|H|   Your pill pack contains 24 pills with active medication. It||
0632|077|H|also contains 4 reminder pills with iron. Take one active pill||
0632|078|H|(with hormones) once daily for 24 days in a row. Take one||
0632|079|H|inactive pill (with iron) once daily for 4 days in a row after||
0632|080|H|you have taken the last active pill unless otherwise directed by||
0632|081|H|your doctor. You should have your period during the fourth week||
0632|082|H|of the pack, within 3 days after the last active pill. After you||
0632|083|H|have taken the last iron pill in the pack, start a new pack the||
0632|084|H|next day even if your period is continuing or if you do not have||
0632|085|H|your period. If you do not get your period, consult your doctor.||
0632|086|H|   If this is the first time you are using this medication and||
0632|087|H|you are not switching from another form of hormonal birth control||
0632|088|H|(such as patch, other birth control pills), take the first pill||
0632|089|H|in the pack on the first Sunday following the beginning of your||
0632|090|H|menstrual period or on the first day of your period. If your||
0632|091|H|period begins on a Sunday, begin taking this medication on that||
0632|092|H|day. For the first cycle of use only, use a backup form of||
0632|093|H|non-hormonal birth control (such as condoms, spermicide) for the||
0632|094|H|first 7 days to prevent pregnancy until the medication has enough||
0632|095|H|time to work. If you start on the first day of your period, you||
0632|096|H|do not need to use backup birth control the first week.||
0632|097|H|   Ask your doctor or pharmacist about how to switch from other||
0632|098|H|forms of hormonal birth control (such as patch, other birth||
0632|099|H|control pills) to this product. If any information is unclear,||
0632|100|H|consult the Patient Information Leaflet or your doctor or||
0632|101|H|pharmacist.||
0632|102|B|||
0632|103|S|SIDE EFFECTS:  Nausea, vomiting, headache, bloating, breast||
0632|104|S|tenderness, swelling of the ankles/feet (fluid retention), or||
0632|105|S|weight change may occur. Vaginal bleeding between periods||
0632|106|S|(spotting) or missed/irregular periods may occur, especially||
0632|107|S|during the first few months of use. If any of these effects last||
0632|108|S|or get worse, tell your doctor or pharmacist promptly. If you||
0632|109|S|miss 2 periods in a row (or 1 period if the pill has not been||
0632|110|S|used properly), contact your doctor for a pregnancy test.||
0632|111|S|   Remember that this medication has been prescribed because your||
0632|112|S|doctor has judged that the benefit to you is greater than the||
0632|113|S|risk of side effects. Many people using this medication do not||
0632|114|S|have serious side effects.||
0632|115|S|   This medication may raise your blood pressure. Check your||
0632|116|S|blood pressure regularly and tell your doctor if the results are||
0632|117|S|high.||
0632|118|S|   Tell your doctor right away if you have any serious side||
0632|119|S|effects, including: lumps in the breast, mental/mood changes||
0632|120|S|(such as new/worsening depression), severe stomach/abdominal||
0632|121|S|pain, unusual changes in vaginal bleeding (such as continuous||
0632|122|S|spotting, sudden heavy bleeding, missed periods), dark urine,||
0632|123|S|yellowing eyes/skin.||
0632|124|S|   This medication may rarely cause serious (sometimes fatal)||
0632|125|S|problems from blood clots (such as heart attack, stroke, blood||
0632|126|S|clots in the lungs or legs). Get medical help right away if you||
0632|127|S|have: chest/jaw/left arm pain, confusion, sudden||
0632|128|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0632|129|S|trouble speaking, shortness of breath/rapid breathing,||
0632|130|S|sudden/severe headaches, unusual sweating, weakness on one side||
0632|131|S|of the body, sudden vision changes.||
0632|132|S|   A very serious allergic reaction to this drug is rare.||
0632|133|S|However, get medical help right away if you notice any symptoms||
0632|134|S|of a serious allergic reaction, including: rash, itching/swelling||
0632|135|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0632|136|S|breathing.||
0632|137|S|   This is not a complete list of possible side effects. If you||
0632|138|S|notice other effects not listed above, contact your doctor or||
0632|139|S|pharmacist.||
0632|140|S|   In the US -||
0632|141|S|   Call your doctor for medical advice about side effects. You||
0632|142|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0632|143|S|www.fda.gov/medwatch.||
0632|144|S|   In Canada - Call your doctor for medical advice about side||
0632|145|S|effects. You may report side effects to Health Canada at||
0632|146|S|1-866-234-2345.||
0632|147|B|||
0632|148|P|PRECAUTIONS:  See also Warning section.||
0632|149|P|   Before using this medication, tell your doctor or pharmacist||
0632|150|P|if you are allergic to ethinyl estradiol, norethindrone, or||
0632|151|P|ferrous fumarate; or to other estrogens, progestins, or iron||
0632|152|P|products; or if you have any other allergies. This product may||
0632|153|P|contain inactive ingredients, which can cause allergic reactions||
0632|154|P|or other problems. Talk to your pharmacist for more details.||
0632|155|P|   Before using this medication, tell your doctor or pharmacist||
0632|156|P|your medical history, especially of: blood clots (for example, in||
0632|157|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
0632|158|P|C or protein S deficiency), high blood pressure, abnormal breast||
0632|159|P|exam, cancer (especially endometrial or breast cancer), high||
0632|160|P|cholesterol or triglyceride (blood fat) levels, depression,||
0632|161|P|diabetes, family or personal history of a certain swelling||
0632|162|P|disorder (angioedema), gallbladder problems, severe||
0632|163|P|headaches/migraines, heart problems (such as heart valve disease,||
0632|164|P|irregular heartbeat, previous heart attack), history of yellowing||
0632|165|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
0632|166|P|birth control (such as pills, patch), kidney disease, liver||
0632|167|P|disease (including tumors), obesity, stroke, swelling (edema),||
0632|168|P|thyroid problems, unexplained vaginal bleeding.||
0632|169|P|   If you have diabetes, this medication may affect your blood||
0632|170|P|sugar. Check your blood sugar regularly as directed and share the||
0632|171|P|results with your doctor. Tell your doctor right away if you have||
0632|172|P|symptoms of high blood sugar such as increased thirst/urination.||
0632|173|P|Your doctor may need to adjust your diabetes medication, exercise||
0632|174|P|program, or diet.||
0632|175|P|   Tell your doctor if you just had or will be having surgery or||
0632|176|P|if you will be confined to a bed or chair for a long time (such||
0632|177|P|as a long plane flight). These conditions increase your risk of||
0632|178|P|getting blood clots, especially if you are using hormonal birth||
0632|179|P|control. You may need to stop this medication for a time or take||
0632|180|P|special precautions.||
0632|181|P|   Before having surgery, tell your doctor or dentist about all||
0632|182|P|the products you use (including prescription drugs,||
0632|183|P|nonprescription drugs, and herbal products).||
0632|184|P|   This medication may cause blotchy, dark areas on your face and||
0632|185|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0632|186|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0632|187|P|wear protective clothing when outdoors.||
0632|188|P|   If you are nearsighted or wear contact lenses, you may develop||
0632|189|P|vision problems or trouble wearing your contact lenses. Contact||
0632|190|P|your eye doctor if these problems occur.||
0632|191|P|   It may take longer for you to become pregnant after you stop||
0632|192|P|taking birth control pills. Consult your doctor.||
0632|193|P|   This medication should not be used during pregnancy. If you||
0632|194|P|become pregnant or think you may be pregnant, tell your doctor||
0632|195|P|right away. If you have just given birth or had a pregnancy||
0632|196|P|loss/abortion after the first 3 months, talk with your doctor||
0632|197|P|about reliable forms of birth control, and find out when it is||
0632|198|P|safe to start using birth control that contains a form of||
0632|199|P|estrogen, such as this medication.||
0632|200|P|   A small amount of this medication passes into breast milk and||
0632|201|P|may have undesirable effects on a nursing infant. Consult your||
0632|202|P|doctor before breastfeeding.||
0632|203|B|||
0632|204|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0632|205|I|medications work or increase your risk for serious side effects.||
0632|206|I|This document does not contain all possible drug interactions.||
0632|207|I|Keep a list of all the products you use (including||
0632|208|I|prescription/nonprescription drugs and herbal products) and share||
0632|209|I|it with your doctor and pharmacist. Do not start, stop, or change||
0632|210|I|the dosage of any medicines without your doctor's approval.||
0632|211|I|   Some products that may interact with this drug include:||
0632|212|I|aromatase inhibitors (such as anastrozole, exemestane),||
0632|213|I|fezolinetant, ospemifene, tamoxifen, tizanidine, tranexamic acid.||
0632|214|I|   Some drugs may cause hormonal birth control to work less well||
0632|215|I|by decreasing the amount of birth control hormones in your body.||
0632|216|I|This effect can result in pregnancy. Examples include||
0632|217|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
0632|218|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
0632|219|I|seizures (such as barbiturates, carbamazepine, felbamate,||
0632|220|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
0632|221|I|nevirapine), among others.||
0632|222|I|   Tell your doctor when you start any new drug, and discuss if||
0632|223|I|you should use reliable backup birth control. Also tell your||
0632|224|I|doctor if you have any new spotting or breakthrough bleeding,||
0632|225|I|because these may be signs that your birth control is not working||
0632|226|I|well.||
0632|227|I|   The iron in the inactive pill can decrease the absorption of||
0632|228|I|certain drugs, especially if you take them around the same time.||
0632|229|I|These drugs include bisphosphonates (such as alendronate),||
0632|230|I|levodopa, penicillamine, quinolone antibiotics (such as||
0632|231|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
0632|232|I|doxycycline, minocycline), thyroid medications (such as||
0632|233|I|levothyroxine), among others. Ask your doctor or pharmacist if||
0632|234|I|you should throw away the inactive pills (iron tablets) each day||
0632|235|I|rather than taking them.||
0632|236|I|   This medication may interfere with certain lab tests (such as||
0632|237|I|blood clotting factors, thyroid), possibly causing false test||
0632|238|I|results. Make sure lab personnel and all your doctors know you||
0632|239|I|use this drug.||
0632|240|B|||
0632|241|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0632|242|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0632|243|O|poison control center right away. US residents can call||
0632|244|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0632|245|O|Symptoms of overdose may include severe nausea and vomiting,||
0632|246|O|sudden/unusual vaginal bleeding.||
0632|247|B|||
0632|248|N|NOTES:  Do not share this medication with others.||
0632|249|N|   Regular complete physical exams which include lab and/or||
0632|250|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
0632|251|N|Pap smear) should be done while you are taking this medication.||
0632|252|N|Follow your doctor's instructions for examining your breasts, and||
0632|253|N|report any lumps right away. Keep all medical and lab||
0632|254|N|appointments. Consult your doctor for more details.||
0632|255|B|||
0632|256|D|MISSED DOSE:  Refer to the product package information for advice||
0632|257|D|on missed doses. You may need to use backup birth control (such||
0632|258|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
0632|259|D|pharmacist if you have any questions.||
0632|260|D|   If you often forget to take your pills as directed, contact||
0632|261|D|your doctor to discuss switching to another form of birth||
0632|262|D|control.||
0632|263|B|||
0632|264|R|STORAGE:  Store at room temperature away from light and moisture.||
0632|265|R|Do not store in the bathroom. Keep all medications away from||
0632|266|R|children and pets.||
0632|267|R|   Do not flush medications down the toilet or pour them into a||
0632|268|R|drain unless instructed to do so. Properly discard this product||
0632|269|R|when it is expired or no longer needed. Consult your pharmacist||
0632|270|R|or local waste disposal company.||
0632|271|B|||
0632|272|A|Information last revised October 2025.||
0632|273|A|Copyright(c) 2025 First Databank, Inc.||
0632|274|B|||
0633|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0633|002|Z|does NOT have all possible information about this product. This||
0633|003|Z|information does not assure that this product is safe, effective,||
0633|004|Z|or appropriate for you. This information is not individual||
0633|005|Z|medical advice and does not substitute for the advice of your||
0633|006|Z|health care professional. Always ask your health care||
0633|007|Z|professional for complete information about this product and your||
0633|008|Z|specific health needs.||
0633|009|B|||
0633|010|T|SELEGILINE - TRANSDERMAL||
0633|011|F|(seh-LEDGE-uh-leen)||
0633|012|B|||
0633|013|C|COMMON BRAND NAME(S): Emsam||
0633|014|B|||
0633|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0633|016|W|of conditions, including depression and other mental/mood||
0633|017|W|disorders. These medications can help prevent suicidal||
0633|018|W|thoughts/attempts and provide other important benefits. However,||
0633|019|W|studies have shown that a small number of people (especially||
0633|020|W|people younger than 25) who take antidepressants for any||
0633|021|W|condition may experience worsening depression, other mental/mood||
0633|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0633|023|W|talk with the doctor about the risks and benefits of||
0633|024|W|antidepressant medication (especially for people younger than||
0633|025|W|25), even if treatment is not for a mental/mood condition.||
0633|026|W|   Tell the doctor right away if you notice worsening||
0633|027|W|depression/other psychiatric conditions, unusual behavior changes||
0633|028|W|(including possible suicidal thoughts/attempts), or other||
0633|029|W|mental/mood changes (including new/worsening anxiety, panic||
0633|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0633|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
0633|032|W|especially watchful for these symptoms when a new antidepressant||
0633|033|W|is started or when the dose is changed.||
0633|034|W|   This medication must not be used by children younger than 12||
0633|035|W|years due to an increased risk of serious side effects (such as||
0633|036|W|extremely high blood pressure). Also, this medication is not||
0633|037|W|recommended for use by children between 12 and 17 years old.||
0633|038|W|Studies have not shown it to work in children in this age group.||
0633|039|B|||
0633|040|U|USES:  See also Warning section.||
0633|041|U|   This medication is used to treat depression. Selegiline||
0633|042|U|belongs to a class of drugs known as monoamine oxidase inhibitors||
0633|043|U|(MAO inhibitors). It works by helping to restore the balance of||
0633|044|U|certain natural substances in the brain. This medication is a||
0633|045|U|patch for use on the skin.||
0633|046|B|||
0633|047|H|HOW TO USE:  Read the Medication Guide provided by your||
0633|048|H|pharmacist before you start using selegiline and each time you||
0633|049|H|get a refill. If you have any questions, ask your doctor or||
0633|050|H|pharmacist.||
0633|051|H|   Follow the package instructions for using this medication.||
0633|052|H|Make sure you understand how to apply a new patch and dispose of||
0633|053|H|the used product. Do not cut the patch into smaller sizes. Do not||
0633|054|H|use the patch if it appears broken, cut or damaged. If you have||
0633|055|H|any questions, consult your doctor or pharmacist.||
0633|056|H|   Before applying the patch, wash the area you will be using for||
0633|057|H|the patch gently and thoroughly with soap and water. Rinse and||
0633|058|H|dry with a clean dry towel. Do not apply the patch to||
0633|059|H|hairy/oily/red/cut/irritated/broken or scarred/calloused skin.||
0633|060|H|Remove the patch from the foil pouch and apply as directed by the||
0633|061|H|manufacturer. Apply one patch to an area of clean dry skin on the||
0633|062|H|upper body (torso), upper thigh, or on the outside of the upper||
0633|063|H|arm where it will not be rubbed by tight clothing. Change the||
0633|064|H|patch daily at about the same time each day. Apply the patch to a||
0633|065|H|different area on your body each time to avoid irritation. If||
0633|066|H|your patch falls off, apply a new patch to a new area and||
0633|067|H|continue on your same schedule.||
0633|068|H|   Be sure to remove the old patch, fold it in half so it sticks||
0633|069|H|to itself, and throw it away out of the reach of children and||
0633|070|H|pets. Do not touch the sticky side with your fingers. Wash your||
0633|071|H|hands with soap and water after handling the patch.||
0633|072|H|   To reduce your risk of side effects, your doctor may start you||
0633|073|H|at a low dose and gradually increase your dose. Once your||
0633|074|H|condition improves and you are better for a while, your doctor||
0633|075|H|may work with you to reduce your regular dose. Follow your||
0633|076|H|doctor's instructions carefully. Do not apply more patches or||
0633|077|H|leave the patch on for longer than prescribed. Your condition||
0633|078|H|will not improve any faster and your risk of side effects will||
0633|079|H|increase.||
0633|080|H|   Use this medication regularly in order to get the most benefit||
0633|081|H|from it. To help you remember, use it at the same time each day.||
0633|082|H|It may take several weeks for the full benefits of this||
0633|083|H|medication to be noticed. Do not stop using this medication||
0633|084|H|without consulting your doctor.||
0633|085|H|   If you are using the higher strength patches (9 or 12||
0633|086|H|milligrams), it is very important that you follow a special diet||
0633|087|H|recommended by your doctor or dietician to limit your intake of||
0633|088|H|tyramine while you are using the medicine and for 2 weeks after||
0633|089|H|stopping the medicine. This will help to prevent a very serious||
0633|090|H|high blood pressure reaction. Avoid foods and beverages that are||
0633|091|H|high in tyramine, including aged cheeses, dried/aged meats and||
0633|092|H|sausages (such as salami, liverwurst), preserved fish (such as||
0633|093|H|pickled herring), products that contain large amounts of yeast||
0633|094|H|(such as bouillon cubes, powdered soup/gravy, homemade or||
0633|095|H|sourdough bread), fermented foods (such as sauerkraut, kim chee),||
0633|096|H|most soybean products (such as soy sauce, tofu), broad/fava||
0633|097|H|beans, red wine, sherry, tap beers, and vermouth. Consult your||
0633|098|H|doctor or dietician for more details and a complete list of other||
0633|099|H|foods that contain tyramine which you should limit or avoid.||
0633|100|H|   Tell your doctor if your condition lasts or gets worse.||
0633|101|B|||
0633|102|S|SIDE EFFECTS:  See also Warning section.||
0633|103|S|   Dizziness, drowsiness, redness/irritation at the application||
0633|104|S|site, tiredness, weakness, problems sleeping, constipation, and||
0633|105|S|dry mouth may occur. If any of these effects last or get worse,||
0633|106|S|tell your doctor or pharmacist promptly.||
0633|107|S|   To reduce the risk of dizziness and lightheadedness, get up||
0633|108|S|slowly when rising from a sitting or lying position.||
0633|109|S|   Remember that this medication has been prescribed because your||
0633|110|S|doctor has judged that the benefit to you is greater than the||
0633|111|S|risk of side effects. Many people using this medication do not||
0633|112|S|have serious side effects.||
0633|113|S|   Tell your doctor right away if you have any serious side||
0633|114|S|effects, including: fainting, mental/mood changes (such as||
0633|115|S|agitation, confusion), muscle stiffness/twitching, changes in||
0633|116|S|sexual ability/interest, shaking (tremor), swollen ankles/legs,||
0633|117|S|unusual weight gain/loss, eye pain/swelling/redness, vision||
0633|118|S|changes (such as double/blurred vision), seizures.||
0633|119|S|   This drug may rarely cause an attack of extremely high blood||
0633|120|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
0633|121|S|food interactions can increase this risk (See also How to Use and||
0633|122|S|Drug Interaction sections). Stop using selegiline and get medical||
0633|123|S|help right away if any of these very serious side effects occur:||
0633|124|S|frequent/severe headache, fast/slow/irregular/pounding heartbeat,||
0633|125|S|chest pain, neck stiffness/soreness, severe nausea/vomiting,||
0633|126|S|sweating/clammy skin (sometimes with fever), widened pupils,||
0633|127|S|sudden sensitivity to light (photophobia).||
0633|128|S|   This medication may increase serotonin and rarely cause a very||
0633|129|S|serious condition called serotonin syndrome. The risk increases||
0633|130|S|if you are also taking other drugs that increase serotonin, so||
0633|131|S|tell your doctor or pharmacist of all the drugs you take. Get||
0633|132|S|medical help right away if you develop some of the following||
0633|133|S|symptoms: hallucinations, unusual restlessness, loss of||
0633|134|S|coordination, fast heartbeat, severe dizziness, unexplained||
0633|135|S|fever, severe nausea/vomiting/diarrhea, twitching muscle.||
0633|136|S|   A very serious allergic reaction to this drug is rare.||
0633|137|S|However, get medical help right away if you notice any symptoms||
0633|138|S|of a serious allergic reaction, including: rash, itching/swelling||
0633|139|S|(especially of the face/tongue/throat), dizziness, trouble||
0633|140|S|breathing.||
0633|141|S|   This is not a complete list of possible side effects. If you||
0633|142|S|notice other effects not listed above, contact your doctor or||
0633|143|S|pharmacist.||
0633|144|S|   In the US -||
0633|145|S|   Call your doctor for medical advice about side effects. You||
0633|146|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0633|147|S|www.fda.gov/medwatch.||
0633|148|S|   In Canada - Call your doctor for medical advice about side||
0633|149|S|effects. You may report side effects to Health Canada at||
0633|150|S|1-866-234-2345.||
0633|151|B|||
0633|152|P|PRECAUTIONS:  Before using selegiline, tell your doctor or||
0633|153|P|pharmacist if you are allergic to it; or if you have any other||
0633|154|P|allergies. This product may contain inactive ingredients, which||
0633|155|P|can cause allergic reactions or other problems. Talk to your||
0633|156|P|pharmacist for more details.||
0633|157|P|   Before using this medication, tell your doctor or pharmacist||
0633|158|P|your medical history, especially of: a certain adrenal gland||
0633|159|P|tumor (pheochromocytoma), cerebrovascular disease (such as||
0633|160|P|stroke), heart problems (such as heart failure, heart attack),||
0633|161|P|personal or family history of high blood pressure, history of||
0633|162|P|severe/frequent headaches, personal/family history of mental/mood||
0633|163|P|disorders (such as bipolar disorder, depression, schizophrenia),||
0633|164|P|liver problems, certain nervous system diseases (Parkinson's||
0633|165|P|syndrome, seizures), overactive thyroid (hyperthyroidism),||
0633|166|P|personal or family history of glaucoma (angle-closure type).||
0633|167|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0633|168|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0633|169|P|machinery, or do anything that needs alertness until you can do||
0633|170|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0633|171|P|are using marijuana (cannabis).||
0633|172|P|   Avoid exposing your skin to direct heat sources such as||
0633|173|P|heating pads, electric blankets, heat lamps, saunas, hot tubs,||
0633|174|P|heated water beds, or prolonged direct sunlight while wearing||
0633|175|P|your selegiline patch. Heat sources may cause more drug to be||
0633|176|P|released into your body, increasing the chance of side effects.||
0633|177|P|   If you are going to have an MRI test, tell testing personnel||
0633|178|P|that you are using this patch. Some patches may contain metals||
0633|179|P|that can cause serious burns during an MRI. Ask your doctor||
0633|180|P|whether you will need to remove your patch before the test and||
0633|181|P|apply a new patch afterward, and how to do so properly.||
0633|182|P|   Before having surgery, tell your doctor or dentist about all||
0633|183|P|the products you use (including prescription drugs,||
0633|184|P|nonprescription drugs, and herbal products). You may need to stop||
0633|185|P|using selegiline before surgery. Follow your doctor's||
0633|186|P|instructions carefully.||
0633|187|P|   Older adults may be more sensitive to the side effects of this||
0633|188|P|drug, especially the effects on blood pressure.||
0633|189|P|   During pregnancy, this medication should be used only when||
0633|190|P|clearly needed. Discuss the risks and benefits with your doctor.||
0633|191|P|   Since untreated mental/mood problems (such as depression) can||
0633|192|P|be a serious condition, do not stop taking this medication unless||
0633|193|P|directed by your doctor. If you are planning pregnancy, become||
0633|194|P|pregnant, or think you may be pregnant, immediately discuss with||
0633|195|P|your doctor the benefits and risks of using this medication||
0633|196|P|during pregnancy.||
0633|197|P|   It is unknown if this drug passes into breast milk. Because of||
0633|198|P|the possible risk to the infant, breastfeeding is not recommended||
0633|199|P|while using this drug and for 5 days after the last dose. Consult||
0633|200|P|your doctor before breastfeeding.||
0633|201|B|||
0633|202|I|DRUG INTERACTIONS:  See also How to Use section.||
0633|203|I|   Drug interactions may change how your medications work or||
0633|204|I|increase your risk for serious side effects. This document does||
0633|205|I|not contain all possible drug interactions. Keep a list of all||
0633|206|I|the products you use (including prescription/nonprescription||
0633|207|I|drugs and herbal products) and share it with your doctor and||
0633|208|I|pharmacist. Do not start, stop, or change the dosage of any||
0633|209|I|medicines without your doctor's approval.||
0633|210|I|   Some products that may interact with selegiline include:||
0633|211|I|antidepressants (including bupropion, maprotiline, mirtazapine),||
0633|212|I|other MAO inhibitors (isocarboxazid, linezolid, metaxalone,||
0633|213|I|methylene blue, moclobemide, phenelzine, procarbazine,||
0633|214|I|rasagiline, safinamide, tranylcypromine), appetite suppressants||
0633|215|I|(such as diethylpropion), drugs for attention deficit disorder||
0633|216|I|(such as atomoxetine, methylphenidate), apraclonidine, buspirone,||
0633|217|I|carbamazepine/oxcarbazepine, cyclobenzaprine, deutetrabenazine,||
0633|218|I|fentanyl, metoclopramide, street drugs (such as LSD, mescaline),||
0633|219|I|supplements (such as tryptophan, tyramine), tetrabenazine,||
0633|220|I|certain "triptans" used to treat migraine headaches (such as||
0633|221|I|rizatriptan, sumatriptan, zolmitriptan), valbenazine.||
0633|222|I|   The risk of serotonin syndrome/toxicity increases if you are||
0633|223|I|also taking other drugs that increase serotonin. Examples include||
0633|224|I|street drugs such as MDMA/"ecstasy," St. John's wort,||
0633|225|I|dextromethorphan, certain antidepressants (including SSRIs such||
0633|226|I|as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine,||
0633|227|I|TCAs such as amitriptyline/doxepin), certain opioid medications||
0633|228|I|(such as meperidine, methadone, pentazocine, propoxyphene,||
0633|229|I|tramadol, tapentadol), among others. The risk of serotonin||
0633|230|I|syndrome/toxicity may be more likely when you start or increase||
0633|231|I|the dose of these drugs.||
0633|232|I|   Tell your doctor or pharmacist if you are using any of these||
0633|233|I|medications before, during, or within 2 weeks after treatment||
0633|234|I|with selegiline. Tell your doctor or pharmacist if you have taken||
0633|235|I|fluoxetine during at least 5 weeks before starting selegiline.||
0633|236|I|Discuss with your doctor how much time to wait between starting||
0633|237|I|or stopping any of these drugs and taking selegiline.||
0633|238|I|   Before using selegiline, report the use of drugs that may||
0633|239|I|increase the risk of extremely high blood pressure (hypertensive||
0633|240|I|crisis) when combined with selegiline, including herbal products||
0633|241|I|(such as ephedra/ma huang), nasal decongestants (such as||
0633|242|I|phenylephrine, pseudoephedrine), and stimulants (such as||
0633|243|I|amphetamines, ephedrine, epinephrine, phenylalanine). Selegiline||
0633|244|I|should not be used with any of these medications. Talk to your||
0633|245|I|doctor or pharmacist for more details.||
0633|246|I|   Check the labels on all your medicines (such as allergy,||
0633|247|I|cough-and-cold products, diet pills) because they may contain||
0633|248|I|dextromethorphan, decongestants, or stimulants. Ask your||
0633|249|I|pharmacist about the safe use of those products.||
0633|250|I|   This medication may interfere with certain medical/lab tests||
0633|251|I|(such as brain scan for Parkinson's disease), possibly causing||
0633|252|I|false test results. Make sure lab personnel and all your doctors||
0633|253|I|know you use this drug.||
0633|254|B|||
0633|255|O|OVERDOSE:  This medication patch may be harmful if chewed or||
0633|256|O|swallowed. If someone has overdosed, remove the patch if||
0633|257|O|possible. For serious symptoms such as passing out or trouble||
0633|258|O|breathing, call 911. Otherwise, call a poison control center||
0633|259|O|right away. US residents can call 1-800-222-1222. Canada||
0633|260|O|residents can call 1-844-764-7669.||
0633|261|B|||
0633|262|N|NOTES:  Do not share this medication with others.||
0633|263|N|   Lab and/or medical tests (such as blood pressure) should be||
0633|264|N|done while you are using this medication. Keep all medical and||
0633|265|N|lab appointments. Consult your doctor for more details.||
0633|266|B|||
0633|267|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
0633|268|D|unless it is close to the time for your next dose. In that case,||
0633|269|D|skip the missed dose. Use your next dose at the regular time. Do||
0633|270|D|not apply 2 doses to catch up.||
0633|271|B|||
0633|272|R|STORAGE:  Store at room temperature. Do not open the foil pouch||
0633|273|R|until you are ready to use the patch. Keep all medications away||
0633|274|R|from children and pets.||
0633|275|R|   Do not flush medications down the toilet or pour them into a||
0633|276|R|drain unless instructed to do so. Properly discard this product||
0633|277|R|when it is expired or no longer needed (See also How to Use||
0633|278|R|section). Consult your pharmacist or local waste disposal||
0633|279|R|company.||
0633|280|B|||
0633|281|M|MEDICAL ALERT:  Your condition can cause complications in a||
0633|282|M|medical emergency. For information about enrolling in MedicAlert,||
0633|283|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0633|284|B|||
0633|285|A|Information last revised November 2025.||
0633|286|A|Copyright(c) 2025 First Databank, Inc.||
0633|287|B|||
0634|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0634|002|Z|does NOT have all possible information about this product. This||
0634|003|Z|information does not assure that this product is safe, effective,||
0634|004|Z|or appropriate for you. This information is not individual||
0634|005|Z|medical advice and does not substitute for the advice of your||
0634|006|Z|health care professional. Always ask your health care||
0634|007|Z|professional for complete information about this product and your||
0634|008|Z|specific health needs.||
0634|009|B|||
0634|010|T|NIACIN (CHOLESTEROL-LOWERING) - ORAL||
0634|011|F|(NYE-a-sin)||
0634|012|B|||
0634|013|C|COMMON BRAND NAME(S): Niacor||
0634|014|B|||
0634|015|U|USES:  Niacin is used with a proper diet and exercise program to||
0634|016|U|help lower "bad" cholesterol and fats (LDL, triglycerides) and||
0634|017|U|raise "good" cholesterol (HDL) in the blood. It is generally used||
0634|018|U|after non-drug treatments have not been fully successful at||
0634|019|U|lowering cholesterol. Niacin is also known as vitamin B-3||
0634|020|U|(nicotinic acid), one of the B-complex vitamins. It may be used||
0634|021|U|with or without other medications. Lowering "bad"||
0634|022|U|cholesterol/triglycerides and raising "good" cholesterol helps||
0634|023|U|prevent strokes and heart attacks. Lowering fats may also help||
0634|024|U|reduce the risk of pancreas problems (pancreatitis) in people at||
0634|025|U|risk.||
0634|026|U|   In addition to eating a proper diet (such as a||
0634|027|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
0634|028|U|help this medication work better include exercising, losing||
0634|029|U|weight if overweight, and stopping smoking. Consult your doctor||
0634|030|U|for more details.||
0634|031|B|||
0634|032|H|HOW TO USE:  Take this medication by mouth with food as directed||
0634|033|H|by your doctor, usually 1-3 times daily. If you take this||
0634|034|H|medicine once daily, take it with your evening meal. Taking||
0634|035|H|niacin on an empty stomach increases side effects (such as||
0634|036|H|flushing, upset stomach).||
0634|037|H|   Niacin is available in different formulations (such as||
0634|038|H|immediate and sustained release). Do not switch between||
0634|039|H|strengths, brands, or forms of niacin. Severe liver problems may||
0634|040|H|occur.||
0634|041|H|   The dosage is based on your medical condition and response to||
0634|042|H|treatment. Generally, your doctor will start you at a low dose||
0634|043|H|and gradually increase your dose in order to minimize side||
0634|044|H|effects. Your dose will need to be increased slowly, even if you||
0634|045|H|are already taking niacin and are being switched from another||
0634|046|H|niacin product (such as extended-release) to this product. Follow||
0634|047|H|your doctor's instructions carefully.||
0634|048|H|   If you also take certain other drugs to lower your cholesterol||
0634|049|H|(bile acid-binding resins such as cholestyramine or colestipol),||
0634|050|H|take niacin at least 4-6 hours before or after taking these||
0634|051|H|medications. These products can react with niacin, preventing its||
0634|052|H|full absorption. Continue to take other medications to lower your||
0634|053|H|cholesterol as directed by your doctor.||
0634|054|H|   To lessen the chance of side effects such as flushing, avoid||
0634|055|H|alcohol, hot beverages, and eating spicy foods near the time you||
0634|056|H|take niacin. Taking a plain (non-enteric coated, 325 milligram)||
0634|057|H|aspirin or a nonsteroidal anti-inflammatory drug (such as||
0634|058|H|ibuprofen, 200 milligrams) 30 minutes before taking niacin may||
0634|059|H|help prevent flushing. Ask your doctor if this treatment is right||
0634|060|H|for you.||
0634|061|H|   Use this medication regularly to get the most benefit from it.||
0634|062|H|To help you remember, take it at the same time each day. Keep||
0634|063|H|taking this medication even if you feel well. Most people with||
0634|064|H|high cholesterol do not feel sick.||
0634|065|H|   Do not stop taking this medicine unless instructed by your||
0634|066|H|doctor. If you stop taking niacin, you may need to return to your||
0634|067|H|original dose and gradually increase it again. Ask your doctor or||
0634|068|H|pharmacist for instructions on restarting your dose if you have||
0634|069|H|not taken your medication for several days.||
0634|070|H|   It is very important to continue to follow your doctor's||
0634|071|H|advice about diet and exercise.||
0634|072|B|||
0634|073|S|SIDE EFFECTS:  Flushing of the face and neck along with warmth,||
0634|074|S|headache, itching, burning, sweating, chills, or tingling may||
0634|075|S|occur within 20 minutes of taking this medication. Flushing may||
0634|076|S|last for a few hours after use. These effects should improve or||
0634|077|S|go away as your body adjusts to the medication. Dizziness,||
0634|078|S|stomach upset, heartburn, nausea, vomiting, and diarrhea may also||
0634|079|S|occur. If any of these effects last or get worse, tell your||
0634|080|S|doctor or pharmacist promptly.||
0634|081|S|   To reduce the risk of dizziness and lightheadedness, get up||
0634|082|S|slowly when rising from a sitting or lying position. This is very||
0634|083|S|important if you are also taking medication to lower your blood||
0634|084|S|pressure.||
0634|085|S|   Remember that this medication has been prescribed because your||
0634|086|S|doctor has judged that the benefit to you is greater than the||
0634|087|S|risk of side effects. Many people using this medication do not||
0634|088|S|have serious side effects.||
0634|089|S|   Tell your doctor right away if you have any serious side||
0634|090|S|effects, including: nausea/vomiting that doesn't stop,||
0634|091|S|fast/irregular heartbeat, severe headache (migraine), unusual||
0634|092|S|joint pain, swelling of legs/arms, vision problems, severe||
0634|093|S|stomach/abdominal pain, black stools, easy bruising/bleeding,||
0634|094|S|unexplained muscle pain/tenderness/weakness, signs of kidney||
0634|095|S|problems (such as change in the amount of urine), dark urine,||
0634|096|S|vomit that looks like coffee grounds, yellowing eyes/skin.||
0634|097|S|   A very serious allergic reaction to this drug is rare.||
0634|098|S|However, get medical help right away if you notice any symptoms||
0634|099|S|of a serious allergic reaction, including: rash, itching/swelling||
0634|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0634|101|S|breathing.||
0634|102|S|   This is not a complete list of possible side effects. If you||
0634|103|S|notice other effects not listed above, contact your doctor or||
0634|104|S|pharmacist.||
0634|105|S|   In the US -||
0634|106|S|   Call your doctor for medical advice about side effects. You||
0634|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0634|108|S|www.fda.gov/medwatch.||
0634|109|S|   In Canada - Call your doctor for medical advice about side||
0634|110|S|effects. You may report side effects to Health Canada at||
0634|111|S|1-866-234-2345.||
0634|112|B|||
0634|113|P|PRECAUTIONS:  Before taking niacin, tell your doctor or||
0634|114|P|pharmacist if you are allergic to it; or if you have any other||
0634|115|P|allergies. This product may contain inactive ingredients, which||
0634|116|P|can cause allergic reactions or other problems. Talk to your||
0634|117|P|pharmacist for more details.||
0634|118|P|   Before using this medication, tell your doctor or pharmacist||
0634|119|P|your medical history, especially of: very low blood pressure,||
0634|120|P|alcohol use, bleeding problems (such as low platelets), diabetes,||
0634|121|P|gallbladder disease, glaucoma, gout, heart disease (such as||
0634|122|P|recent heart attack, unstable angina), kidney disease, liver||
0634|123|P|disease/increase in liver enzymes, untreated mineral imbalance||
0634|124|P|(low phosphate levels), stomach/intestinal ulcers, underactive||
0634|125|P|thyroid (hypothyroidism).||
0634|126|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0634|127|P|can make you more dizzy. Do not drive, use machinery, or do||
0634|128|P|anything that needs alertness until you can do it safely. Limit||
0634|129|P|alcoholic beverages. Talk to your doctor if you are using||
0634|130|P|marijuana (cannabis).||
0634|131|P|   Before having surgery, tell your doctor or dentist about all||
0634|132|P|the products you use (including prescription drugs,||
0634|133|P|nonprescription drugs, and herbal products).||
0634|134|P|   This medication may rarely make your blood sugar rise, which||
0634|135|P|can cause or worsen diabetes. If you already have diabetes, check||
0634|136|P|your blood sugar regularly as directed and share the results with||
0634|137|P|your doctor. Tell your doctor right away if you have symptoms of||
0634|138|P|high blood sugar such as increased thirst/urination. Your doctor||
0634|139|P|may need to adjust your diabetes medication, exercise program, or||
0634|140|P|diet.||
0634|141|P|   During pregnancy, this medication should be used only when||
0634|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
0634|143|P|   This medication passes into breast milk. Consult your doctor||
0634|144|P|before breastfeeding.||
0634|145|B|||
0634|146|I|DRUG INTERACTIONS:  See also How to Use section.||
0634|147|I|   Drug interactions may change how your medications work or||
0634|148|I|increase your risk for serious side effects. This document does||
0634|149|I|not contain all possible drug interactions. Keep a list of all||
0634|150|I|the products you use (including prescription/nonprescription||
0634|151|I|drugs and herbal products) and share it with your doctor and||
0634|152|I|pharmacist. Do not start, stop, or change the dosage of any||
0634|153|I|medicines without your doctor's approval.||
0634|154|I|   Check all prescription and nonprescription medicine labels||
0634|155|I|carefully since vitamins/dietary supplements may also contain||
0634|156|I|niacin or niacinamide (nicotinamide). These may increase your||
0634|157|I|risk of side effects if taken together. Ask your doctor or||
0634|158|I|pharmacist for more details.||
0634|159|I|   This medication may interfere with certain lab tests (such as||
0634|160|I|urine or blood catecholamines, copper-based urine glucose tests),||
0634|161|I|possibly causing false test results. Make sure lab personnel and||
0634|162|I|all your doctors know you use this drug.||
0634|163|B|||
0634|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0634|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0634|166|O|poison control center right away. US residents can call||
0634|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0634|168|B|||
0634|169|N|NOTES:  Do not share this medication with others.||
0634|170|N|   Lab tests (such as blood lipids, blood sugar, liver function)||
0634|171|N|should be done while you are taking this medication. Keep all||
0634|172|N|medical and lab appointments. Consult your doctor for more||
0634|173|N|details.||
0634|174|B|||
0634|175|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0634|176|D|remember. If it is near the time of the next dose, skip the||
0634|177|D|missed dose. Take your next dose at the regular time. Do not||
0634|178|D|double the dose to catch up.||
0634|179|B|||
0634|180|R|STORAGE:  Store at room temperature away from light and moisture.||
0634|181|R|Do not store in the bathroom. Keep all medications away from||
0634|182|R|children and pets.||
0634|183|R|   Do not flush medications down the toilet or pour them into a||
0634|184|R|drain unless instructed to do so. Properly discard this product||
0634|185|R|when it is expired or no longer needed. Consult your pharmacist||
0634|186|R|or local waste disposal company.||
0634|187|B|||
0634|188|A|Information last revised May 2024.||
0634|189|A|Copyright(c) 2025 First Databank, Inc.||
0634|190|B|||
0635|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0635|002|Z|does NOT have all possible information about this product. This||
0635|003|Z|information does not assure that this product is safe, effective,||
0635|004|Z|or appropriate for you. This information is not individual||
0635|005|Z|medical advice and does not substitute for the advice of your||
0635|006|Z|health care professional. Always ask your health care||
0635|007|Z|professional for complete information about this product and your||
0635|008|Z|specific health needs.||
0635|009|B|||
0635|010|T|NIACINAMIDE - ORAL||
0635|011|F|(NYE-a-SIN-a-mide)||
0635|012|B|||
0635|013|U|USES:  Niacinamide (nicotinamide) is a form of vitamin B3||
0635|014|U|(niacin) and is used to prevent and treat niacin deficiency||
0635|015|U|(pellagra). Niacin deficiency can cause diarrhea, confusion||
0635|016|U|(dementia), tongue redness/swelling, and peeling red skin.||
0635|017|U|Niacinamide is often used instead of niacin because it causes||
0635|018|U|fewer side effects (such as flushing). Unlike niacin, niacinamide||
0635|019|U|does not help correct blood fat levels and cannot be substituted||
0635|020|U|for niacin if you are being treated for a blood fat problem (such||
0635|021|U|as high cholesterol).||
0635|022|U|   Niacin deficiency may happen as a result of poor diet, certain||
0635|023|U|medical conditions (such as alcohol abuse, malabsorption||
0635|024|U|syndrome, Hartnup disease), or long-term use of certain||
0635|025|U|medications (such as isoniazid). It is best to get your vitamins||
0635|026|U|from healthy foods. A multivitamin may be recommended by your||
0635|027|U|doctor instead of niacinamide because poor diet usually causes||
0635|028|U|deficiencies in more than one vitamin. Vitamins help to support||
0635|029|U|the body's ability to make and break down natural substances||
0635|030|U|(metabolism) and are needed for good health.||
0635|031|B|||
0635|032|H|HOW TO USE:  Take this product by mouth as directed, usually once||
0635|033|H|or twice daily. Follow all directions on the product package, or||
0635|034|H|use as directed by your doctor. If you have any questions, ask||
0635|035|H|your doctor or pharmacist.||
0635|036|H|   Do not crush or chew extended-release tablets. Doing so can||
0635|037|H|release all of the drug at once, increasing the risk of side||
0635|038|H|effects. Also, do not split the tablets unless they have a score||
0635|039|H|line and your doctor or pharmacist tells you to do so. Swallow||
0635|040|H|the whole or split tablet without crushing or chewing.||
0635|041|H|   If you take certain drugs to lower blood fats (bile||
0635|042|H|acid-binding resins such as cholestyramine or colestipol), take||
0635|043|H|niacinamide at least 4 to 6 hours before or after taking these||
0635|044|H|medications. These products may bind with niacinamide, preventing||
0635|045|H|its full absorption.||
0635|046|H|   If your condition lasts or gets worse, or if you think you may||
0635|047|H|have a serious medical problem, get medical help right away.||
0635|048|B|||
0635|049|S|SIDE EFFECTS:  Niacinamide is generally well tolerated in usual||
0635|050|S|doses. Upset stomach, nausea, and diarrhea may occur. If any of||
0635|051|S|these effects last or get worse, notify your doctor or pharmacist||
0635|052|S|promptly.||
0635|053|S|   If your doctor has directed you to use this medication,||
0635|054|S|remember that your doctor has judged that the benefit to you is||
0635|055|S|greater than the risk of side effects. Many people using this||
0635|056|S|medication do not have serious side effects.||
0635|057|S|   Tell your doctor right away if you have any serious side||
0635|058|S|effects, including: nausea/vomiting that doesn't stop,||
0635|059|S|black/tarry stools, easy bruising/bleeding, swelling of||
0635|060|S|arms/legs, signs of kidney problems (such as change in the amount||
0635|061|S|of urine), dark urine, vomit that looks like coffee grounds,||
0635|062|S|yellowing eyes/skin.||
0635|063|S|   A very serious allergic reaction to this drug is rare.||
0635|064|S|However, get medical help right away if you notice any symptoms||
0635|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0635|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0635|067|S|breathing.||
0635|068|S|   This is not a complete list of possible side effects. If you||
0635|069|S|notice other effects not listed above, contact your doctor or||
0635|070|S|pharmacist.||
0635|071|S|   In the US -||
0635|072|S|   Call your doctor for medical advice about side effects. You||
0635|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0635|074|S|www.fda.gov/medwatch.||
0635|075|S|   In Canada - Call your doctor for medical advice about side||
0635|076|S|effects. You may report side effects to Health Canada at||
0635|077|S|1-866-234-2345.||
0635|078|B|||
0635|079|P|PRECAUTIONS:  Before taking niacinamide, tell your doctor or||
0635|080|P|pharmacist if you are allergic to it; or if you have any other||
0635|081|P|allergies. This product may contain inactive ingredients, which||
0635|082|P|can cause allergic reactions or other problems. Talk to your||
0635|083|P|pharmacist for more details.||
0635|084|P|   If you have any of the following health problems, consult your||
0635|085|P|doctor or pharmacist before using this product: liver disease,||
0635|086|P|stomach/ulcer problems, bleeding problems (low platelets),||
0635|087|P|diabetes, gout, kidney disease.||
0635|088|P|   If you have diabetes, this drug may increase your blood sugar.||
0635|089|P|Check your blood sugar regularly as directed and share the||
0635|090|P|results with your doctor. Tell your doctor right away if you have||
0635|091|P|symptoms of high blood sugar such as increased thirst/urination.||
0635|092|P|Your doctor may need to adjust your diabetes medication, exercise||
0635|093|P|program, or diet.||
0635|094|P|   Tell your doctor if you are pregnant before using this||
0635|095|P|medication.||
0635|096|P|   This drug passes into breast milk. Consult your doctor before||
0635|097|P|breastfeeding.||
0635|098|B|||
0635|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0635|100|I|medications work or increase your risk for serious side effects.||
0635|101|I|This document does not contain all possible drug interactions.||
0635|102|I|Keep a list of all the products you use (including||
0635|103|I|prescription/nonprescription drugs and herbal products) and share||
0635|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
0635|105|I|the dosage of any medicines without your doctor's approval.||
0635|106|I|   Check all prescription and nonprescription medicine labels||
0635|107|I|carefully since vitamins/dietary supplements may also contain||
0635|108|I|niacin or niacinamide (nicotinamide). These may increase your||
0635|109|I|risk of side effects if taken together. Ask your doctor or||
0635|110|I|pharmacist for more details.||
0635|111|B|||
0635|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0635|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0635|114|O|poison control center right away. US residents can call||
0635|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0635|116|B|||
0635|117|N|NOTES:  Lab tests (such as blood sugar, liver function) may be||
0635|118|N|done while you are taking this medication. Keep all medical and||
0635|119|N|lab appointments. Consult your doctor for more details.||
0635|120|N|   Remember that it is best to get your vitamins and minerals||
0635|121|N|from healthy foods. Maintain a well-balanced diet, and follow any||
0635|122|N|dietary guidelines as directed by your doctor. B vitamins||
0635|123|N|(including niacin) are found in meat, fish, poultry,||
0635|124|N|enriched/whole grain bread products, and fortified cereals. Eat||
0635|125|N|more of these foods to increase the amount of niacin in your diet||
0635|126|N|if you have a niacin deficiency.||
0635|127|B|||
0635|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0635|129|D|remember. If it is near the time of the next dose, skip the||
0635|130|D|missed dose. Take your next dose at the regular time. Do not||
0635|131|D|double the dose to catch up.||
0635|132|B|||
0635|133|R|STORAGE:  Refer to storage information printed on the package. If||
0635|134|R|you have any questions about storage, ask your pharmacist. Keep||
0635|135|R|all medications away from children and pets.||
0635|136|R|   Do not flush medications down the toilet or pour them into a||
0635|137|R|drain unless instructed to do so. Properly discard this product||
0635|138|R|when it is expired or no longer needed. Consult your pharmacist||
0635|139|R|or local waste disposal company.||
0635|140|B|||
0635|141|A|Information last revised May 2024.||
0635|142|A|Copyright(c) 2025 First Databank, Inc.||
0635|143|B|||
0637|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0637|002|Z|does NOT have all possible information about this product. This||
0637|003|Z|information does not assure that this product is safe, effective,||
0637|004|Z|or appropriate for you. This information is not individual||
0637|005|Z|medical advice and does not substitute for the advice of your||
0637|006|Z|health care professional. Always ask your health care||
0637|007|Z|professional for complete information about this product and your||
0637|008|Z|specific health needs.||
0637|009|B|||
0637|010|T|BEZAFIBRATE SUSTAINED-RELEASE - ORAL||
0637|011|F|(BE-za-FYE-brate)||
0637|012|B|||
0637|013|U|USES:  Bezafibrate is used along with a proper diet to help lower||
0637|014|U|"bad" cholesterol and fats (such as LDL, triglycerides) and raise||
0637|015|U|"good" cholesterol (HDL) in the blood. It works by increasing the||
0637|016|U|natural substance (enzyme) that breaks down fats in the blood.||
0637|017|U|Bezafibrate belongs to a class of drugs known as "fibrates."||
0637|018|U|Lowering triglycerides in people with very high triglyceride||
0637|019|U|blood levels may decrease the risk of pancreas disease||
0637|020|U|(pancreatitis). Reducing "bad" cholesterol and triglycerides||
0637|021|U|lowers the risk of heart disease and helps prevent strokes and||
0637|022|U|heart attacks.||
0637|023|U|   In addition to eating a proper diet (such as a||
0637|024|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
0637|025|U|help this medication work better include exercising, losing||
0637|026|U|weight if overweight, and stopping smoking. Consult your doctor||
0637|027|U|for more details.||
0637|028|B|||
0637|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0637|030|H|from your pharmacist before you start taking this medication and||
0637|031|H|each time you get a refill. If you have any questions, ask your||
0637|032|H|doctor or pharmacist.||
0637|033|H|   Take this medication by mouth with or after a meal as directed||
0637|034|H|by your doctor, usually once daily.||
0637|035|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
0637|036|H|Doing so can release all of the drug at once, increasing the risk||
0637|037|H|of side effects.||
0637|038|H|   If you are also taking certain other drugs to lower your||
0637|039|H|cholesterol (bile acid-binding resins such as cholestyramine or||
0637|040|H|colestipol), take bezafibrate at least 2 hours before or after||
0637|041|H|taking these medications. These medications can bind to||
0637|042|H|bezafibrate, preventing your body from fully absorbing the drug.||
0637|043|H|   The dosage is based on your medical condition and response to||
0637|044|H|treatment.||
0637|045|H|   Take this medication regularly to get the most benefit from||
0637|046|H|it. To help you remember, take it at the same time each day. Do||
0637|047|H|not increase your dose or use this drug more often or for longer||
0637|048|H|than prescribed. Your cholesterol/triglyceride level will not||
0637|049|H|lower faster and your risk of side effects will increase.||
0637|050|H|   Keep taking this medication even if you feel well. Most people||
0637|051|H|with high triglycerides/cholesterol do not feel sick.||
0637|052|H|   It is very important to continue to follow your doctor's||
0637|053|H|advice about diet and exercise. It may take up to 3 months to get||
0637|054|H|the full benefit from this medication.||
0637|055|B|||
0637|056|S|SIDE EFFECTS:  Stomach/abdominal upset, gas, or diarrhea may||
0637|057|S|occur. If any of these effects last or get worse, tell your||
0637|058|S|doctor or pharmacist promptly.||
0637|059|S|   Remember that this medication has been prescribed because your||
0637|060|S|doctor has judged that the benefit to you is greater than the||
0637|061|S|risk of side effects. Many people using this medication do not||
0637|062|S|have serious side effects.||
0637|063|S|   This medication may rarely cause gallstones and liver||
0637|064|S|problems. If you notice any of the following unlikely but serious||
0637|065|S|side effects, tell your doctor right away: nausea/vomiting that||
0637|066|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
0637|067|S|eyes/skin, dark urine.||
0637|068|S|   This medication may rarely cause muscle problems (which can||
0637|069|S|rarely lead to a very serious condition called rhabdomyolysis).||
0637|070|S|Tell your doctor right away if you develop any of these symptoms:||
0637|071|S|muscle pain/tenderness/weakness (especially with fever or unusual||
0637|072|S|tiredness), signs of kidney problems (such as change in the||
0637|073|S|amount of urine).||
0637|074|S|   Tell your doctor right away if you have any serious side||
0637|075|S|effects, including: signs of infection (such as sore throat that||
0637|076|S|doesn't go away, fever, chills), easy bruising/bleeding, unusual||
0637|077|S|tiredness.||
0637|078|S|   A very serious allergic reaction to this drug is rare.||
0637|079|S|However, get medical help right away if you notice any symptoms||
0637|080|S|of a serious allergic reaction, including: rash, itching/swelling||
0637|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0637|082|S|breathing.||
0637|083|S|   This is not a complete list of possible side effects. If you||
0637|084|S|notice other effects not listed above, contact your doctor or||
0637|085|S|pharmacist.||
0637|086|S|   In the US -||
0637|087|S|   Call your doctor for medical advice about side effects. You||
0637|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0637|089|S|www.fda.gov/medwatch.||
0637|090|S|   In Canada - Call your doctor for medical advice about side||
0637|091|S|effects. You may report side effects to Health Canada at||
0637|092|S|1-866-234-2345.||
0637|093|B|||
0637|094|P|PRECAUTIONS:  See also Side Effects section.||
0637|095|P|   Before taking bezafibrate, tell your doctor or pharmacist if||
0637|096|P|you are allergic to it; or to other "fibrates" (such as||
0637|097|P|fenofibrate, gemfibrozil); or if you have any other allergies.||
0637|098|P|This product may contain inactive ingredients, which can cause||
0637|099|P|allergic reactions or other problems. Talk to your pharmacist for||
0637|100|P|more details.||
0637|101|P|   Before using this medication, tell your doctor or pharmacist||
0637|102|P|your medical history, especially of: liver disease (such as||
0637|103|P|biliary cholangitis, hepatitis), gallbladder disease, kidney||
0637|104|P|disease, alcohol use.||
0637|105|P|   Before having surgery, tell your doctor or dentist about all||
0637|106|P|the products you use (including prescription drugs,||
0637|107|P|nonprescription drugs, and herbal products).||
0637|108|P|   Older adults may be more sensitive to the side effects of this||
0637|109|P|drug, especially muscle problems.||
0637|110|P|   This medication must not be used during pregnancy. It may harm||
0637|111|P|an unborn baby. Discuss the use of reliable forms of birth||
0637|112|P|control (such as condoms, birth control pills) with your doctor.||
0637|113|P|If you become pregnant or think you may be pregnant, tell your||
0637|114|P|doctor right away.||
0637|115|P|   It is unknown if this medication passes into breast milk.||
0637|116|P|Because of the possible risk to the infant, breastfeeding is not||
0637|117|P|recommended while using this medication. Consult your doctor||
0637|118|P|before breastfeeding.||
0637|119|B|||
0637|120|I|DRUG INTERACTIONS:  See also How to Use section.||
0637|121|I|   Drug interactions may change how your medications work or||
0637|122|I|increase your risk for serious side effects. This document does||
0637|123|I|not contain all possible drug interactions. Keep a list of all||
0637|124|I|the products you use (including prescription/nonprescription||
0637|125|I|drugs and herbal products) and share it with your doctor and||
0637|126|I|pharmacist. Do not start, stop, or change the dosage of any||
0637|127|I|medicines without your doctor's approval.||
0637|128|I|   Some products that may interact with this drug include: "blood||
0637|129|I|thinners" (such as warfarin).||
0637|130|B|||
0637|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0637|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0637|133|O|poison control center right away. US residents can call||
0637|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0637|135|B|||
0637|136|N|NOTES:  Do not share this medication with others.||
0637|137|N|   Lab and/or medical tests (such as triglyceride and cholesterol||
0637|138|N|levels, liver/kidney function, complete blood count) should be||
0637|139|N|done while you are taking this medication. Keep all medical and||
0637|140|N|lab appointments. Consult your doctor for more details.||
0637|141|B|||
0637|142|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0637|143|D|remember. If it is near the time of the next dose, skip the||
0637|144|D|missed dose. Take your next dose at the regular time. Do not||
0637|145|D|double the dose to catch up.||
0637|146|B|||
0637|147|R|STORAGE:  Store at room temperature away from light and moisture.||
0637|148|R|Do not store in the bathroom. Keep all medications away from||
0637|149|R|children and pets.||
0637|150|R|   Do not flush medications down the toilet or pour them into a||
0637|151|R|drain unless instructed to do so. Properly discard this product||
0637|152|R|when it is expired or no longer needed. Consult your pharmacist||
0637|153|R|or local waste disposal company.||
0637|154|B|||
0637|155|A|Information last revised April 2025.||
0637|156|A|Copyright(c) 2025 First Databank, Inc.||
0637|157|B|||
0638|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0638|002|Z|does NOT have all possible information about this product. This||
0638|003|Z|information does not assure that this product is safe, effective,||
0638|004|Z|or appropriate for you. This information is not individual||
0638|005|Z|medical advice and does not substitute for the advice of your||
0638|006|Z|health care professional. Always ask your health care||
0638|007|Z|professional for complete information about this product and your||
0638|008|Z|specific health needs.||
0638|009|B|||
0638|010|T|MENOTROPINS - SUBCUTANEOUS INJECTION||
0638|011|F|(men-oh-TROW-pins)||
0638|012|B|||
0638|013|C|COMMON BRAND NAME(S): Menopur||
0638|014|B|||
0638|015|U|USES:  This medication is used to treat certain fertility||
0638|016|U|problems in women. It provides follicle stimulating hormone (FSH)||
0638|017|U|and luteinizing hormone (LH) that help healthy ovaries to make||
0638|018|U|eggs. This medication is usually used in combination with another||
0638|019|U|hormone (human chorionic gonadotropin-hCG) to help you become||
0638|020|U|pregnant by bringing about the growth and release of a mature egg||
0638|021|U|(ovulation).||
0638|022|U|   This medication is not recommended for women whose ovaries no||
0638|023|U|longer make eggs properly (primary ovarian failure).||
0638|024|B|||
0638|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
0638|026|H|Instructions for Use if available from your pharmacist before||
0638|027|H|starting this medication and each time you get a refill. Ask your||
0638|028|H|health care professional how to prepare and use this medication.||
0638|029|H|If you have any questions, ask your doctor or pharmacist.||
0638|030|H|   Inject this medication under the skin as directed by your||
0638|031|H|doctor. The injection is given in the abdomen. The dosage and||
0638|032|H|length of treatment are based on your medical condition, response||
0638|033|H|to treatment and other medications you may be taking. Be sure to||
0638|034|H|tell your doctor and pharmacist about all the products you use||
0638|035|H|(including prescription drugs, nonprescription drugs, and herbal||
0638|036|H|products).||
0638|037|H|   Use the solution immediately after the medication is mixed.||
0638|038|H|Before using, check this product for particles or discoloration.||
0638|039|H|If either is present, do not use the liquid. Before injecting||
0638|040|H|each dose, clean the skin you are going to inject into (the||
0638|041|H|injection site) with rubbing alcohol. Change the injection site||
0638|042|H|each time to lessen injury under the skin. To lessen bruising, do||
0638|043|H|not rub the injection site after a shot. Learn how to store and||
0638|044|H|discard medical supplies safely.||
0638|045|H|   Use this medication exactly as directed by your doctor in||
0638|046|H|order to get the most benefit from it. To help you remember, use||
0638|047|H|it at the same time each day. Do not change the dose or use this||
0638|048|H|drug for a longer period than prescribed unless instructed by||
0638|049|H|your doctor.||
0638|050|B|||
0638|051|S|SIDE EFFECTS:  Headache, mild stomach pain/bloating, redness/pain||
0638|052|S|at the injection site, breast tenderness, or dizziness may occur.||
0638|053|S|If any of these effects last or get worse, notify your doctor or||
0638|054|S|pharmacist promptly.||
0638|055|S|   Remember that this medication has been prescribed because your||
0638|056|S|doctor has judged that the benefit to you is greater than the||
0638|057|S|risk of side effects. Many people using this medication do not||
0638|058|S|have serious side effects.||
0638|059|S|   Tell your doctor right away if you have any serious side||
0638|060|S|effects, including: flu-like symptoms (such as fever, chills,||
0638|061|S|joint pain, muscle ache, tiredness).||
0638|062|S|   Get medical help right away if you have any very serious side||
0638|063|S|effects, including: weakness on one side of the body, trouble||
0638|064|S|speaking, sudden vision changes, sudden severe headache,||
0638|065|S|pain/swelling of the calf muscles, chest pain, shortness of||
0638|066|S|breath.||
0638|067|S|   This medication may cause a condition known as ovarian||
0638|068|S|hyperstimulation syndrome (OHSS). This condition may occur during||
0638|069|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
0638|070|S|build up in the stomach, chest, and heart area. Get medical help||
0638|071|S|right away if you develop the following side effects: severe pain||
0638|072|S|or swelling in the lower abdominal (pelvic) area, severe||
0638|073|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
0638|074|S|urination.||
0638|075|S|   A very serious allergic reaction to this drug is rare.||
0638|076|S|However, get medical help right away if you notice any symptoms||
0638|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0638|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0638|079|S|breathing.||
0638|080|S|   This is not a complete list of possible side effects. If you||
0638|081|S|notice other effects not listed above, contact your doctor or||
0638|082|S|pharmacist.||
0638|083|S|   In the US -||
0638|084|S|   Call your doctor for medical advice about side effects. You||
0638|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0638|086|S|www.fda.gov/medwatch.||
0638|087|S|   In Canada - Call your doctor for medical advice about side||
0638|088|S|effects. You may report side effects to Health Canada at||
0638|089|S|1-866-234-2345.||
0638|090|B|||
0638|091|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0638|092|P|pharmacist if you are allergic to it; or to other products||
0638|093|P|containing follicle stimulating hormone or luteinizing hormone;||
0638|094|P|or if you have any other allergies. This product may contain||
0638|095|P|inactive ingredients, which can cause allergic reactions or other||
0638|096|P|problems. Talk to your pharmacist for more details.||
0638|097|P|   Before using this medication, tell your doctor or pharmacist||
0638|098|P|your medical history, especially of: other fertility problems||
0638|099|P|(such as primary ovarian failure), abnormal uterine/vaginal||
0638|100|P|bleeding, thyroid problems, adrenal gland problems, cancer of the||
0638|101|P|reproductive organs (breast, uterus, ovary), tumor in the brain||
0638|102|P|(such as a pituitary tumor), ovarian cysts/enlarged ovaries (not||
0638|103|P|due to polycystic ovary syndrome), twisting of the ovary (ovarian||
0638|104|P|torsion), personal/family history of blood clots, blood clotting||
0638|105|P|disorders (such as thrombophilia), obesity, stroke, certain heart||
0638|106|P|diseases (such as heart attack), lung problems (such as asthma).||
0638|107|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0638|108|P|can make you more dizzy. Do not drive, use machinery, or do||
0638|109|P|anything that needs alertness until you can do it safely. Limit||
0638|110|P|alcoholic beverages. Talk to your doctor if you are using||
0638|111|P|marijuana (cannabis).||
0638|112|P|   Multiple births may occur because of this treatment. Consult||
0638|113|P|your doctor for more details.||
0638|114|P|   Stop using this medication when you become pregnant. This||
0638|115|P|medication must not be used during pregnancy. If you think you||
0638|116|P|may be pregnant, tell your doctor right away.||
0638|117|P|   It is unknown if this drug passes into breast milk. Consult||
0638|118|P|your doctor before breastfeeding.||
0638|119|B|||
0638|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0638|121|I|medications work or increase your risk for serious side effects.||
0638|122|I|This document does not contain all possible drug interactions.||
0638|123|I|Keep a list of all the products you use (including||
0638|124|I|prescription/nonprescription drugs and herbal products) and share||
0638|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
0638|126|I|the dosage of any medicines without your doctor's approval.||
0638|127|I|   A product that may interact with this drug is: gonadorelin.||
0638|128|B|||
0638|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0638|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0638|131|O|poison control center right away. US residents can call||
0638|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0638|133|B|||
0638|134|N|NOTES:  Do not share this medication with others.||
0638|135|N|   Lab and/or medical tests (such as blood hormone tests such as||
0638|136|N|estradiol level, vaginal ultrasound) should be done while you are||
0638|137|N|using this medication. Keep all medical and lab appointments.||
0638|138|N|Consult your doctor for more details.||
0638|139|N|   Lifestyle changes that may help improve the effect of this||
0638|140|N|medication include limiting alcohol and stopping smoking. Consult||
0638|141|N|your doctor or pharmacist to discuss lifestyle changes that might||
0638|142|N|benefit you.||
0638|143|B|||
0638|144|D|MISSED DOSE:  It is important to use this medication on a fixed||
0638|145|D|schedule exactly as prescribed by your doctor. If you miss a||
0638|146|D|dose, contact your doctor or pharmacist right away for||
0638|147|D|instructions. Do not double the dose to catch up.||
0638|148|B|||
0638|149|R|STORAGE:  Store the unmixed medication in the refrigerator or at||
0638|150|R|room temperature. Protect from light. Do not freeze. Discard any||
0638|151|R|unused portion after use. Keep all medications away from children||
0638|152|R|and pets.||
0638|153|R|   Do not flush medications down the toilet or pour them into a||
0638|154|R|drain unless instructed to do so. Properly discard this product||
0638|155|R|when it is expired or no longer needed. Consult your pharmacist||
0638|156|R|or local waste disposal company.||
0638|157|B|||
0638|158|A|Information last revised December 2024.||
0638|159|A|Copyright(c) 2025 First Databank, Inc.||
0638|160|B|||
0639|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0639|002|Z|does NOT have all possible information about this product. This||
0639|003|Z|information does not assure that this product is safe, effective,||
0639|004|Z|or appropriate for you. This information is not individual||
0639|005|Z|medical advice and does not substitute for the advice of your||
0639|006|Z|health care professional. Always ask your health care||
0639|007|Z|professional for complete information about this product and your||
0639|008|Z|specific health needs.||
0639|009|B|||
0639|010|T|OMEGA-3 ACID ETHYL ESTERS - ORAL||
0639|011|F|(oh-MAY-gah 3 AS-id ETH-il ES-ters)||
0639|012|B|||
0639|013|C|COMMON BRAND NAME(S): Lovaza||
0639|014|B|||
0639|015|U|USES:  Omega-3 acid ethyl esters, a type of fat found in fish||
0639|016|U|oil, is used along with diet and exercise to help lower levels of||
0639|017|U|a certain blood fat (triglyceride). It may also raise "good"||
0639|018|U|cholesterol (HDL). In general, this drug is used after your blood||
0639|019|U|fat levels have not been fully controlled by non-drug treatments||
0639|020|U|(such as diet changes, exercise, decreasing alcohol intake,||
0639|021|U|weight loss if overweight, controlling blood sugar if diabetic,||
0639|022|U|and regulating your thyroid hormone levels).||
0639|023|U|   Lowering triglycerides and increasing "good" cholesterol may||
0639|024|U|help decrease the risk for strokes and heart attacks. Omega-3||
0639|025|U|acid ethyl esters are thought to work by decreasing the amount of||
0639|026|U|triglyceride the body makes.||
0639|027|B|||
0639|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0639|029|H|from your pharmacist before you start taking this medication and||
0639|030|H|each time you get a refill. If you have any questions, ask your||
0639|031|H|doctor or pharmacist.||
0639|032|H|   Take this medication by mouth with food as directed by your||
0639|033|H|doctor, usually once or twice a day. Swallow the capsules whole.||
0639|034|H|Do not crush, chew, or dissolve the capsules.||
0639|035|H|   Do not substitute other omega-3 fatty acids or fish oil||
0639|036|H|products (such as nonprescription products, vitamins,||
0639|037|H|supplements) for this product without talking with your doctor||
0639|038|H|first. They may not contain the same amount and type of fatty||
0639|039|H|acids.||
0639|040|H|   The dosage is based on your medical condition and response to||
0639|041|H|treatment. Use this medication regularly to get the most benefit||
0639|042|H|from it. To help you remember, take it at the same time(s) each||
0639|043|H|day. Keep taking this medication even if you feel well. Most||
0639|044|H|people with high triglycerides do not feel sick.||
0639|045|H|   It is very important to continue to follow your doctor's||
0639|046|H|advice about diet and exercise. It may take up to 2 months to get||
0639|047|H|the full benefits of this drug.||
0639|048|B|||
0639|049|S|SIDE EFFECTS:  Upset stomach, burping, and strange taste in mouth||
0639|050|S|may occur. If these effects last or get worse, tell your doctor||
0639|051|S|or pharmacist promptly.||
0639|052|S|   Remember that this medication has been prescribed because your||
0639|053|S|doctor has judged that the benefit to you is greater than the||
0639|054|S|risk of side effects. Many people using this medication do not||
0639|055|S|have serious side effects.||
0639|056|S|   Tell your doctor right away if you have any serious side||
0639|057|S|effects, including: easy bleeding/bruising.||
0639|058|S|   A very serious allergic reaction to this drug is rare.||
0639|059|S|However, get medical help right away if you notice any symptoms||
0639|060|S|of a serious allergic reaction, including: rash, itching/swelling||
0639|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0639|062|S|breathing.||
0639|063|S|   This is not a complete list of possible side effects. If you||
0639|064|S|notice other effects not listed above, contact your doctor or||
0639|065|S|pharmacist.||
0639|066|S|   In the US -||
0639|067|S|   Call your doctor for medical advice about side effects. You||
0639|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0639|069|S|www.fda.gov/medwatch.||
0639|070|S|   In Canada - Call your doctor for medical advice about side||
0639|071|S|effects. You may report side effects to Health Canada at||
0639|072|S|1-866-234-2345.||
0639|073|B|||
0639|074|P|PRECAUTIONS:  Before taking omega-3 acid ethyl esters, tell your||
0639|075|P|doctor or pharmacist if you are allergic to it; or to fish, or||
0639|076|P|shellfish, or soy products; or if you have any other allergies.||
0639|077|P|This product may contain inactive ingredients, which can cause||
0639|078|P|allergic reactions or other problems. Talk to your pharmacist for||
0639|079|P|more details.||
0639|080|P|   Before using this medication, tell your doctor or pharmacist||
0639|081|P|your medical history, especially of: alcohol use, diabetes, liver||
0639|082|P|disease, underactive thyroid (hypothyroidism).||
0639|083|P|   Before having surgery, tell your doctor or dentist about all||
0639|084|P|the products you use (including prescription drugs,||
0639|085|P|nonprescription drugs, and herbal products).||
0639|086|P|   During pregnancy, this medication should be used only when||
0639|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
0639|088|P|   This medication passes into breast milk. Consult your doctor||
0639|089|P|before breastfeeding.||
0639|090|B|||
0639|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0639|092|I|medications work or increase your risk for serious side effects.||
0639|093|I|This document does not contain all possible drug interactions.||
0639|094|I|Keep a list of all the products you use (including||
0639|095|I|prescription/nonprescription drugs and herbal products) and share||
0639|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
0639|097|I|the dosage of any medicines without your doctor's approval.||
0639|098|I|   Some products that may interact with this drug include: drugs||
0639|099|I|which can increase triglycerides (such as beta blockers,||
0639|100|I|estrogens, certain "water pills"/diuretics such as thiazides),||
0639|101|I|other vitamins/supplements (such as fish/flaxseed/cod liver||
0639|102|I|oils).||
0639|103|B|||
0639|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0639|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0639|106|O|poison control center right away. US residents can call||
0639|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0639|108|B|||
0639|109|N|NOTES:  Do not share this medication with others.||
0639|110|N|   Lab and/or medical tests (such as liver function,||
0639|111|N|triglyceride/lipid levels) may be done while you are taking this||
0639|112|N|medication. Keep all medical and lab appointments. Consult your||
0639|113|N|doctor for more details.||
0639|114|N|   For best results, this medication should be used along with a||
0639|115|N|doctor-approved diet, exercise, and weight control. Consult your||
0639|116|N|doctor about other ways to lower your heart disease risk.||
0639|117|B|||
0639|118|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0639|119|D|remember. If it is near the time of the next dose, skip the||
0639|120|D|missed dose. Take your next dose at the regular time. Do not||
0639|121|D|double the dose to catch up.||
0639|122|B|||
0639|123|R|STORAGE:  Store at room temperature away from light and moisture.||
0639|124|R|Do not freeze. Do not store in the bathroom. Keep all medications||
0639|125|R|away from children and pets.||
0639|126|R|   Do not flush medications down the toilet or pour them into a||
0639|127|R|drain unless instructed to do so. Properly discard this product||
0639|128|R|when it is expired or no longer needed. Consult your pharmacist||
0639|129|R|or local waste disposal company.||
0639|130|B|||
0639|131|A|Information last revised May 2024.||
0639|132|A|Copyright(c) 2025 First Databank, Inc.||
0639|133|B|||
0640|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0640|002|Z|does NOT have all possible information about this product. This||
0640|003|Z|information does not assure that this product is safe, effective,||
0640|004|Z|or appropriate for you. This information is not individual||
0640|005|Z|medical advice and does not substitute for the advice of your||
0640|006|Z|health care professional. Always ask your health care||
0640|007|Z|professional for complete information about this product and your||
0640|008|Z|specific health needs.||
0640|009|B|||
0640|010|T|LENALIDOMIDE - ORAL||
0640|011|F|(LEN-a-LID-oh-mide)||
0640|012|B|||
0640|013|C|COMMON BRAND NAME(S): Revlimid||
0640|014|B|||
0640|015|W|WARNING:  Lenalidomide is very similar to thalidomide, a drug||
0640|016|W|which has caused severe (possibly fatal) birth defects when used||
0640|017|W|during pregnancy. If lenalidomide is taken during pregnancy, it||
0640|018|W|may also cause severe (possibly fatal) birth defects. Women who||
0640|019|W|are pregnant or who may become pregnant must not use||
0640|020|W|lenalidomide. Women must have two negative pregnancy tests before||
0640|021|W|starting lenalidomide (the first test 10 to 14 days before the||
0640|022|W|first dose and the second test within 24 hours before the first||
0640|023|W|dose). Women must also continue to have pregnancy tests regularly||
0640|024|W|during treatment (every 2 to 4 weeks).||
0640|025|W|   Female patients must use 2 effective forms of birth control||
0640|026|W|(or completely avoid sexual intercourse) for 4 weeks before||
0640|027|W|starting lenalidomide, during use, and for 4 weeks after stopping||
0640|028|W|this drug. Talk to your doctor about reliable birth control||
0640|029|W|choices. If your period is late or if you have irregular||
0640|030|W|bleeding, or if you have sexual intercourse at any time without||
0640|031|W|using 2 effective forms of birth control, stop taking this||
0640|032|W|medication and contact your doctor right away.||
0640|033|W|   Because lenalidomide also passes into semen, men who use this||
0640|034|W|drug and have sex with women must use a latex condom during all||
0640|035|W|sexual contact, even if they have had a vasectomy. Keep using||
0640|036|W|condoms and other birth control as directed until 4 weeks after||
0640|037|W|lenalidomide treatment has been stopped.||
0640|038|W|   You should have a blood test for hepatitis B virus before||
0640|039|W|starting treatment. Some people with this virus may have a||
0640|040|W|serious flare-up when using lenalidomide.||
0640|041|W|   To receive lenalidomide in the United States, you must||
0640|042|W|understand, agree to, and carefully follow the requirements of||
0640|043|W|the REMS Program for this medication. If you live in Canada or||
0640|044|W|any other country, consult your doctor and pharmacist for your||
0640|045|W|country's regulations.||
0640|046|W|   This medication may cause a low number of white blood cells||
0640|047|W|and platelets. Your doctor will monitor you closely while you||
0640|048|W|take this medication and may adjust the dose of the medication or||
0640|049|W|stop the medication based on your lab test results. Get medical||
0640|050|W|help right away if you develop any of the following symptoms:||
0640|051|W|signs of infection (such as sore throat that doesn't go away,||
0640|052|W|fever, swollen lymph nodes, chills), easy bleeding/bruising.||
0640|053|W|   Lenalidomide may rarely cause serious problems from blood||
0640|054|W|clots (such as heart attack, stroke, blood clots in the lungs or||
0640|055|W|legs). You may be at increased risk for blood clots if you smoke,||
0640|056|W|or have a history of blood clots, high blood pressure, or high||
0640|057|W|cholesterol, or if you are immobile (such as on very long plane||
0640|058|W|flights or being bedridden). If you use estrogen-containing||
0640|059|W|products, these may also increase your risk. To lower your risk,||
0640|060|W|your doctor may prescribe an additional medication. Before using||
0640|061|W|lenalidomide, if you have any of these conditions report them to||
0640|062|W|your doctor or pharmacist. Get medical help right away if any of||
0640|063|W|these side effects occur: shortness of breath/rapid breathing,||
0640|064|W|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
0640|065|W|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0640|066|W|sudden/severe headaches, trouble speaking, weakness on one side||
0640|067|W|of the body, sudden vision changes.||
0640|068|B|||
0640|069|U|USES:  Lenalidomide is used to treat various types of cancers. It||
0640|070|U|works by slowing or stopping the growth of cancer cells. It is||
0640|071|U|also used to treat anemia in patients with certain blood/bone||
0640|072|U|marrow disorders (myelodysplastic syndromes-MDS). Lenalidomide||
0640|073|U|may lessen the need for blood transfusions.||
0640|074|U|   Lenalidomide is not recommended for the treatment of a certain||
0640|075|U|type of cancer (chronic lymphocytic leukemia) because of the||
0640|076|U|increased risk of serious heart-related side effects and death.||
0640|077|U|If you have this type of cancer, talk to your doctor about the||
0640|078|U|risks of using this medication.||
0640|079|B|||
0640|080|V|OTHER USES:  This section contains uses of this drug that are not||
0640|081|V|listed in the approved professional labeling for the drug but||
0640|082|V|that may be prescribed by your health care professional. Use this||
0640|083|V|drug for a condition that is listed in this section only if it||
0640|084|V|has been so prescribed by your health care professional.||
0640|085|V|   This drug may also be used for lupus.||
0640|086|B|||
0640|087|H|HOW TO USE:  Read the Medication Guide provided by your||
0640|088|H|pharmacist before you start taking lenalidomide and each time you||
0640|089|H|get a refill. If you have any questions, ask your doctor or||
0640|090|H|pharmacist.||
0640|091|H|   Take this medication by mouth with or without food as directed||
0640|092|H|by your doctor, usually once daily. Swallow this medication whole||
0640|093|H|with water. For treatment of certain conditions, you may be||
0640|094|H|instructed to take this medication in cycles (once daily for 21||
0640|095|H|days, then stopping the medication for 7 days). The dosage is||
0640|096|H|based on your medical condition, response to treatment, and lab||
0640|097|H|test results. Be sure to follow your doctor's directions||
0640|098|H|carefully.||
0640|099|H|   Do not open, chew, or break the capsules, or handle them any||
0640|100|H|more than needed. If any of the powder from the capsule gets on||
0640|101|H|your skin, wash the area with soap and water.||
0640|102|H|   Since this drug can be absorbed through the skin and lungs and||
0640|103|H|may harm an unborn baby, women who are pregnant or who may become||
0640|104|H|pregnant should not handle this medication or breathe the dust||
0640|105|H|from broken capsules. All people should wash their hands||
0640|106|H|thoroughly after handling this drug.||
0640|107|H|   Use this medication regularly to get the most benefit from it.||
0640|108|H|Remember to take it at the same time each day.||
0640|109|H|   Do not increase your dose or use this drug more often or for||
0640|110|H|longer than prescribed. Your condition will not improve any||
0640|111|H|faster, and your risk of side effects will increase.||
0640|112|B|||
0640|113|S|SIDE EFFECTS:  See also Warning section.||
0640|114|S|   Diarrhea, stomach/abdominal pain, nausea/vomiting, loss of||
0640|115|S|appetite, constipation, dizziness, dry skin, dry mouth, or||
0640|116|S|trouble sleeping may occur. If any of these effects last or get||
0640|117|S|worse, tell your doctor or pharmacist promptly.||
0640|118|S|   People using this medication may have serious side effects.||
0640|119|S|However, you have been prescribed this drug because your doctor||
0640|120|S|has judged that the benefit to you is greater than the risk of||
0640|121|S|side effects. Careful monitoring by your doctor may decrease your||
0640|122|S|risk.||
0640|123|S|   Tell your doctor right away if you have any serious side||
0640|124|S|effects, including: mental/mood changes (such as depression),||
0640|125|S|increased thirst/urination, shaking (tremor), numbness/tingling||
0640|126|S|of arms/legs, fast/slow/irregular heartbeat, symptoms of heart||
0640|127|S|failure (such as shortness of breath, swelling ankles/feet,||
0640|128|S|unusual tiredness, unusual/sudden weight gain).||
0640|129|S|   Some people treated with this medication may rarely get other||
0640|130|S|cancers. Consult your doctor for more details.||
0640|131|S|   Lenalidomide sometimes causes side effects due to the rapid||
0640|132|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
0640|133|S|risk, your doctor may add a medication and tell you to drink||
0640|134|S|plenty of fluids. Tell your doctor right away if you have||
0640|135|S|symptoms such as: low back/side pain (flank pain), signs of||
0640|136|S|kidney problems (such as painful urination, pink/bloody urine,||
0640|137|S|change in the amount of urine), muscle spasms/weakness.||
0640|138|S|   People taking lenalidomide may have worsening of their||
0640|139|S|symptoms (tumor flare reaction). If you have tender/swollen lymph||
0640|140|S|nodes, fever, pain, or rash, contact your doctor right away.||
0640|141|S|   This drug helps many people live longer. However, some people||
0640|142|S|who have used lenalidomide have died sooner than expected,||
0640|143|S|especially if they had high white blood cell or tumor cell||
0640|144|S|counts. Talk with your doctor about the risks and benefits of||
0640|145|S|using this medication.||
0640|146|S|   Lenalidomide may rarely cause serious (possibly fatal) liver||
0640|147|S|disease. Get medical help right away if you have any symptoms of||
0640|148|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
0640|149|S|appetite, severe stomach/abdominal pain, yellowing eyes/skin,||
0640|150|S|dark urine.||
0640|151|S|   Lenalidomide can commonly cause a rash that is usually not||
0640|152|S|serious. However, you may not be able to tell it apart from a||
0640|153|S|rare rash that could be a sign of a severe reaction. Get medical||
0640|154|S|help right away if you develop any rash.||
0640|155|S|   A very serious allergic reaction to this drug is rare.||
0640|156|S|However, get medical help right away if you notice any symptoms||
0640|157|S|of a serious allergic reaction, including: rash, itching/swelling||
0640|158|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0640|159|S|breathing.||
0640|160|S|   This is not a complete list of possible side effects. If you||
0640|161|S|notice other effects not listed above, contact your doctor or||
0640|162|S|pharmacist.||
0640|163|S|   In the US -||
0640|164|S|   Call your doctor for medical advice about side effects. You||
0640|165|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0640|166|S|www.fda.gov/medwatch.||
0640|167|S|   In Canada - Call your doctor for medical advice about side||
0640|168|S|effects. You may report side effects to Health Canada at||
0640|169|S|1-866-234-2345.||
0640|170|B|||
0640|171|P|PRECAUTIONS:  See also Warning section.||
0640|172|P|   Before taking lenalidomide, tell your doctor or pharmacist if||
0640|173|P|you are allergic to it; or to thalidomide; or if you have any||
0640|174|P|other allergies. This product may contain inactive ingredients||
0640|175|P|(such as lactose), which can cause allergic reactions or other||
0640|176|P|problems. Talk to your pharmacist for more details.||
0640|177|P|   Before using this medication, tell your doctor or pharmacist||
0640|178|P|your medical history, especially of: kidney disease, liver||
0640|179|P|disease (such as hepatitis B), thyroid disease, chicken pox and||
0640|180|P|shingles (herpes zoster infection), organ transplant.||
0640|181|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0640|182|P|can make you more dizzy. Do not drive, use machinery, or do||
0640|183|P|anything that needs alertness until you can do it safely. Limit||
0640|184|P|alcoholic beverages. Talk to your doctor if you are using||
0640|185|P|marijuana (cannabis).||
0640|186|P|   Lenalidomide can make you more likely to get infections or may||
0640|187|P|make current infections worse. Stay away from anyone who has an||
0640|188|P|infection that may easily spread (such as chickenpox, COVID-19,||
0640|189|P|measles, flu). Talk to your doctor if you have been exposed to an||
0640|190|P|infection or for more details.||
0640|191|P|   Tell your health care professional that you are using||
0640|192|P|lenalidomide before having any immunizations/vaccinations. Avoid||
0640|193|P|contact with people who have recently received live vaccines||
0640|194|P|(such as flu vaccine inhaled through the nose).||
0640|195|P|   To lower the chance of getting cut, bruised, or injured, use||
0640|196|P|caution with sharp objects like razors and nail cutters, and||
0640|197|P|avoid activities such as contact sports.||
0640|198|P|   Do not donate blood or sperm while using lenalidomide and for||
0640|199|P|4 weeks after stopping this drug.||
0640|200|P|   Older adults may be more sensitive to the side effects of this||
0640|201|P|drug.||
0640|202|P|   Since this drug can be absorbed through the skin and lungs and||
0640|203|P|may harm an unborn baby, women who are pregnant or who may become||
0640|204|P|pregnant should not handle this medication or breathe the dust||
0640|205|P|from broken capsules.||
0640|206|P|   Lenalidomide must not be used during pregnancy. It may harm an||
0640|207|P|unborn baby. If you become pregnant or think you may be pregnant,||
0640|208|P|stop taking lenalidomide and tell your doctor right away. If you||
0640|209|P|are male and have had unprotected sex with a woman who is or can||
0640|210|P|become pregnant, or if you think your sexual partner may be||
0640|211|P|pregnant, tell both of your doctors right away.||
0640|212|P|   It is unknown if lenalidomide passes into breast milk. Because||
0640|213|P|of the possible risk to the infant, breastfeeding is not||
0640|214|P|recommended while using this medication. Consult your doctor||
0640|215|P|before breastfeeding.||
0640|216|B|||
0640|217|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0640|218|I|medications work or increase your risk for serious side effects.||
0640|219|I|This document does not contain all possible drug interactions.||
0640|220|I|Keep a list of all the products you use (including||
0640|221|I|prescription/nonprescription drugs and herbal products) and share||
0640|222|I|it with your doctor and pharmacist. Do not start, stop, or change||
0640|223|I|the dosage of any medicines without your doctor's approval.||
0640|224|B|||
0640|225|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0640|226|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0640|227|O|poison control center right away. US residents can call||
0640|228|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0640|229|B|||
0640|230|N|NOTES:  Do not share this medication with others.||
0640|231|N|   Lab and/or medical tests (such as complete blood count,||
0640|232|N|kidney/liver/thyroid function, blood mineral levels, pregnancy||
0640|233|N|test) should be done while you are taking this medication. Keep||
0640|234|N|all medical and lab appointments. Consult your doctor for more||
0640|235|N|details.||
0640|236|B|||
0640|237|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0640|238|D|remember. If it is more than 12 hours after the missed dose, skip||
0640|239|D|the missed dose. Take your next dose at the regular time. Do not||
0640|240|D|double the dose to catch up.||
0640|241|B|||
0640|242|R|STORAGE:  Store at room temperature away from light and moisture.||
0640|243|R|Do not store in the bathroom. Keep all medications away from||
0640|244|R|children and pets.||
0640|245|R|   Do not flush medications down the toilet or pour them into a||
0640|246|R|drain unless instructed to do so. Properly discard this product||
0640|247|R|when it is expired or no longer needed. Consult your pharmacist||
0640|248|R|or local waste disposal company.||
0640|249|B|||
0640|250|M|MEDICAL ALERT:  Your condition can cause complications in a||
0640|251|M|medical emergency. For information about enrolling in MedicAlert,||
0640|252|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0640|253|B|||
0640|254|A|Information last revised April 2025.||
0640|255|A|Copyright(c) 2025 First Databank, Inc.||
0640|256|B|||
0641|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0641|002|Z|does NOT have all possible information about this product. This||
0641|003|Z|information does not assure that this product is safe, effective,||
0641|004|Z|or appropriate for you. This information is not individual||
0641|005|Z|medical advice and does not substitute for the advice of your||
0641|006|Z|health care professional. Always ask your health care||
0641|007|Z|professional for complete information about this product and your||
0641|008|Z|specific health needs.||
0641|009|B|||
0641|010|T|METHYLPHENIDATE - TRANSDERMAL||
0641|011|F|(METH-il-FEN-i-date)||
0641|012|B|||
0641|013|C|COMMON BRAND NAME(S): Daytrana||
0641|014|B|||
0641|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
0641|016|W|serious (possibly fatal) heart and blood pressure problems.||
0641|017|W|   This medication can be habit-forming and should be used||
0641|018|W|cautiously by people who have mental/mood disorders or a||
0641|019|W|substance use disorder (such as overuse of or addiction to||
0641|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
0641|021|W|you have a personal or family history of a substance use||
0641|022|W|disorder. Do not increase your dose, use it more often, or use it||
0641|023|W|for a longer time or in a different way than prescribed. Doing so||
0641|024|W|may result in a decrease in the effect of this drug, drug||
0641|025|W|dependence, or abnormal thoughts/behavior.||
0641|026|W|   Your doctor may monitor you for a while after the medication||
0641|027|W|is stopped, especially if you have used this drug for a long time||
0641|028|W|or in high doses. (See also How to Use section.)||
0641|029|B|||
0641|030|U|USES:  This medication is used to treat attention deficit||
0641|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
0641|032|U|of certain natural substances in the brain. Methylphenidate||
0641|033|U|belongs to a class of drugs known as stimulants. It can help||
0641|034|U|increase your ability to pay attention, stay focused on an||
0641|035|U|activity, and control behavior problems. It may also help you to||
0641|036|U|organize your tasks and improve listening skills.||
0641|037|B|||
0641|038|H|HOW TO USE:  Read the Medication Guide provided by your||
0641|039|H|pharmacist before you start using methylphenidate and each time||
0641|040|H|you get a refill. Read and follow all directions in the||
0641|041|H|Instructions for Use. Learn how to properly use, store, and||
0641|042|H|discard the patches. If you have any questions, ask your doctor||
0641|043|H|or pharmacist.||
0641|044|H|   Apply this medication to the skin as directed by your doctor,||
0641|045|H|usually once daily in the morning, 2 hours before you need the||
0641|046|H|effects of this drug. Then remove the patch as directed by your||
0641|047|H|doctor, usually 9 hours later. Applying this medication late in||
0641|048|H|the day may cause trouble sleeping (insomnia). If you apply this||
0641|049|H|patch in the early morning and still have trouble sleeping, your||
0641|050|H|doctor may direct you to remove the patch within less than 9||
0641|051|H|hours. Carefully follow your doctor's instructions.||
0641|052|H|   This medication should be applied to a clean, dry area of skin||
0641|053|H|on the hip. Before applying the patch, gently wash, rinse, and||
0641|054|H|dry the application area. Do not apply to cut or irritated skin.||
0641|055|H|Remove the patch from the pouch and apply right away as directed.||
0641|056|H|Do not cut the patch. When using a new patch the next day, apply||
0641|057|H|to an area of skin on the other hip to avoid irritation. Do not||
0641|058|H|apply a heating pad or other heat to the patch area since this||
0641|059|H|may increase the risk of side effects. Bathing, swimming, or||
0641|060|H|showering may affect how well the patch stays on the skin. If the||
0641|061|H|patch does not stick properly or falls off, replace with a new||
0641|062|H|patch at another site. Remove the new patch at your usual time,||
0641|063|H|usually 9 hours after applying the first patch.||
0641|064|H|   After removing the patch, fold it in half with the sticky||
0641|065|H|sides together and throw it away as directed. Do not touch the||
0641|066|H|sticky side with your fingers. Wash your hands after applying or||
0641|067|H|removing the patch.||
0641|068|H|   Use this medication regularly to get the most benefit from it.||
0641|069|H|To help you remember, use it at the same time each day.||
0641|070|H|   The dosage is based on your medical condition and response to||
0641|071|H|treatment. Your doctor may direct you to gradually increase or||
0641|072|H|decrease your dose. Also, if you have used it for a long time, do||
0641|073|H|not suddenly stop using this drug without consulting your doctor.||
0641|074|H|   If you suddenly stop using this medication, you may have||
0641|075|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
0641|076|H|other mental/mood changes). To help prevent withdrawal, your||
0641|077|H|doctor may lower your dose slowly. Withdrawal is more likely if||
0641|078|H|you have used methylphenidate for a long time or in high doses.||
0641|079|H|Tell your doctor or pharmacist right away if you have withdrawal.||
0641|080|H|   When used for a long time, this medication may not work as||
0641|081|H|well. Talk with your doctor if this medication stops working||
0641|082|H|well.||
0641|083|H|   Though it helps many people, this medication may sometimes||
0641|084|H|cause addiction. This risk may be higher if you have a substance||
0641|085|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0641|086|H|Use this medication exactly as prescribed to lower the risk of||
0641|087|H|addiction. Ask your doctor or pharmacist for more details.||
0641|088|H|   Tell your doctor if your condition does not get better or if||
0641|089|H|it gets worse.||
0641|090|B|||
0641|091|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
0641|092|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
0641|093|S|Mild irritation or redness at the application site may also||
0641|094|S|occur. If any of these effects last or get worse, tell your||
0641|095|S|doctor or pharmacist promptly.||
0641|096|S|   Remember that this medication has been prescribed because your||
0641|097|S|doctor has judged that the benefit to you is greater than the||
0641|098|S|risk of side effects. Many people using this medication do not||
0641|099|S|have serious side effects.||
0641|100|S|   This medication may raise your blood pressure. Check your||
0641|101|S|blood pressure regularly and tell your doctor if the results are||
0641|102|S|high.||
0641|103|S|   Tell your doctor right away if you have any serious side||
0641|104|S|effects, including: signs of blood flow problems in the fingers||
0641|105|S|or toes (such as coldness, numbness, pain, or skin color||
0641|106|S|changes), unusual wounds on the fingers or toes,||
0641|107|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
0641|108|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
0641|109|S|thoughts of suicide), uncontrolled muscle movements (such as||
0641|110|S|twitching, shaking), sudden outbursts of words/sounds that are||
0641|111|S|hard to control, vision changes (such as blurred vision), slow||
0641|112|S|healing sores/ulcers on the tips of fingers/toes.||
0641|113|S|   Get medical help right away if you have any very serious side||
0641|114|S|effects, including: fainting, seizure, symptoms of a heart attack||
0641|115|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
0641|116|S|sweating), symptoms of a stroke (such as weakness on one side of||
0641|117|S|the body, trouble speaking, sudden vision changes, confusion).||
0641|118|S|   Rarely, males (including young boys and teens) may have a||
0641|119|S|painful or prolonged erection lasting 4 or more hours while using||
0641|120|S|this medication. Caregivers/parents should also be watchful for||
0641|121|S|this serious side effect in boys. If a painful or prolonged||
0641|122|S|erection occurs, stop using this drug and get medical help right||
0641|123|S|away, or permanent problems could occur. Ask your doctor or||
0641|124|S|pharmacist for more details.||
0641|125|S|   This patch may cause the skin under it to lighten (whiten) in||
0641|126|S|color. This may sometimes occur even on skin that was never||
0641|127|S|covered by this patch. The lightened skin color may be permanent,||
0641|128|S|so tell your doctor right away if you notice any skin color||
0641|129|S|changes.||
0641|130|S|   A very serious allergic reaction to this drug is rare.||
0641|131|S|However, get medical help right away if you notice any symptoms||
0641|132|S|of a serious allergic reaction, including: rash, itching/swelling||
0641|133|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0641|134|S|breathing.||
0641|135|S|   This is not a complete list of possible side effects. If you||
0641|136|S|notice other effects not listed above, contact your doctor or||
0641|137|S|pharmacist.||
0641|138|S|   In the US -||
0641|139|S|   Call your doctor for medical advice about side effects. You||
0641|140|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0641|141|S|www.fda.gov/medwatch.||
0641|142|S|   In Canada - Call your doctor for medical advice about side||
0641|143|S|effects. You may report side effects to Health Canada at||
0641|144|S|1-866-234-2345.||
0641|145|B|||
0641|146|P|PRECAUTIONS:  See also Warning section.||
0641|147|P|   Before using methylphenidate, tell your doctor or pharmacist||
0641|148|P|if you are allergic to it; or to dexmethylphenidate; or if you||
0641|149|P|have any other allergies. This product may contain inactive||
0641|150|P|ingredients, which can cause allergic reactions or other||
0641|151|P|problems. Talk to your pharmacist for more details.||
0641|152|P|   Before using this medication, tell your doctor or pharmacist||
0641|153|P|your medical history, especially of: high blood pressure, blood||
0641|154|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
0641|155|P|problems (such as irregular heartbeat, heart failure, previous||
0641|156|P|heart attack, problems with heart structure), family history of||
0641|157|P|heart problems (such as sudden cardiac death, irregular||
0641|158|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
0641|159|P|agitation), personal/family history of mental/mood disorders||
0641|160|P|(such as bipolar disorder, depression, psychosis, suicidal||
0641|161|P|thoughts), personal/family history of uncontrolled muscle||
0641|162|P|movements (motor tics, Tourette's syndrome), personal/family||
0641|163|P|history of a certain skin condition (vitiligo), overactive||
0641|164|P|thyroid (hyperthyroidism), seizure disorder.||
0641|165|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0641|166|P|can make you more dizzy. Do not drive, use machinery, or do||
0641|167|P|anything that needs alertness until you can do it safely. Limit||
0641|168|P|alcoholic beverages. Talk to your doctor if you are using||
0641|169|P|marijuana (cannabis).||
0641|170|P|   If you are going to have an MRI test, tell testing personnel||
0641|171|P|that you are using this patch. Some patches may contain metals||
0641|172|P|that can cause serious burns during an MRI. Ask your doctor||
0641|173|P|whether you will need to remove your patch before the test and||
0641|174|P|apply a new patch afterward, and how to do so properly.||
0641|175|P|   Before having surgery, tell your doctor or dentist about all||
0641|176|P|the products you use (including prescription drugs,||
0641|177|P|nonprescription drugs, and herbal products).||
0641|178|P|   Children (especially those younger than 6) may be more||
0641|179|P|sensitive to the side effects of this drug, especially weight||
0641|180|P|loss. If used for a long time, this drug may affect a child's||
0641|181|P|growth rate, weight, and final adult height. To reduce the risk,||
0641|182|P|the doctor may recommend briefly stopping the medication from||
0641|183|P|time to time. Check the child's weight and height regularly, and||
0641|184|P|consult your doctor or pharmacist for more details.||
0641|185|P|   Older adults may be more sensitive to the side effects of this||
0641|186|P|drug, especially trouble sleeping, weight loss, or chest pain.||
0641|187|P|   During pregnancy, methylphenidate should be used only when||
0641|188|P|clearly needed. Discuss the risks and benefits with your doctor.||
0641|189|P|   This medication passes into breast milk. Consult your doctor||
0641|190|P|before breastfeeding.||
0641|191|B|||
0641|192|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0641|193|I|medications work or increase your risk for serious side effects.||
0641|194|I|This document does not contain all possible drug interactions.||
0641|195|I|Keep a list of all the products you use (including||
0641|196|I|prescription/nonprescription drugs and herbal products) and share||
0641|197|I|it with your doctor and pharmacist. Do not start, stop, or change||
0641|198|I|the dosage of any medicines without your doctor's approval.||
0641|199|I|   Taking MAO inhibitors with this medication may cause a serious||
0641|200|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0641|201|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0641|202|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0641|203|I|selegiline, tranylcypromine) during treatment with this||
0641|204|I|medication. Most MAO inhibitors should also not be taken for two||
0641|205|I|weeks before treatment with this medication. Ask your doctor when||
0641|206|I|to start or stop taking this medication.||
0641|207|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
0641|208|I|use medications containing dexmethylphenidate while using||
0641|209|I|methylphenidate.||
0641|210|I|   This medication may interfere with certain medical/lab tests||
0641|211|I|(such as brain scan for Parkinson's disease), possibly causing||
0641|212|I|false test results. Make sure lab personnel and all your doctors||
0641|213|I|know you use this drug.||
0641|214|B|||
0641|215|O|OVERDOSE:  This medication patch may be harmful if chewed or||
0641|216|O|swallowed. If someone has overdosed, remove the patch if||
0641|217|O|possible. For serious symptoms such as passing out or trouble||
0641|218|O|breathing, call 911. Otherwise, call a poison control center||
0641|219|O|right away. US residents can call 1-800-222-1222. Canada||
0641|220|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0641|221|O|include: vomiting, agitation, confusion, sweating, flushing,||
0641|222|O|muscle twitching, hallucinations, seizures, loss of||
0641|223|O|consciousness.||
0641|224|B|||
0641|225|N|NOTES:  Do not share this medication with others. Sharing it is||
0641|226|N|against the law.||
0641|227|N|   Lab and/or medical tests (such as blood pressure, complete||
0641|228|N|blood count, height/weight monitoring in children) may be done||
0641|229|N|while you are using this medication. Keep all medical and lab||
0641|230|N|appointments. Consult your doctor for more details.||
0641|231|N|   If switching from another form of methylphenidate to this||
0641|232|N|patch, carefully follow your doctor's instructions.||
0641|233|B|||
0641|234|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0641|235|D|If it is near bedtime or near the time of the next dose, skip the||
0641|236|D|missed dose. Use your next dose at the regular time. Do not||
0641|237|D|double the dose to catch up.||
0641|238|B|||
0641|239|R|STORAGE:  Store at room temperature. Do not refrigerate or||
0641|240|R|freeze. The patches come in individual pouches which are stored||
0641|241|R|in a sealed tray. Once the sealed tray is opened, the patches||
0641|242|R|expire after 2 months. Do not open the individual pouch until you||
0641|243|R|are ready to use the patch. Keep all medications away from||
0641|244|R|children and pets.||
0641|245|R|   Do not flush medications down the toilet or pour them into a||
0641|246|R|drain unless instructed to do so. Properly discard this product||
0641|247|R|when it is expired or no longer needed (see also How to Use||
0641|248|R|section). For more details, read the Instructions for Use, or||
0641|249|R|consult your pharmacist or local waste disposal company.||
0641|250|B|||
0641|251|A|Information last revised July 2025.||
0641|252|A|Copyright(c) 2025 First Databank, Inc.||
0641|253|B|||
0642|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0642|002|Z|does NOT have all possible information about this product. This||
0642|003|Z|information does not assure that this product is safe, effective,||
0642|004|Z|or appropriate for you. This information is not individual||
0642|005|Z|medical advice and does not substitute for the advice of your||
0642|006|Z|health care professional. Always ask your health care||
0642|007|Z|professional for complete information about this product and your||
0642|008|Z|specific health needs.||
0642|009|B|||
0642|010|T|INSULIN REGULAR (PORK) - INJECTION||
0642|011|F|(IN-su-lin)||
0642|012|B|||
0642|013|U|USES:  Insulin regular is used with a proper diet and exercise||
0642|014|U|program to control high blood sugar in people with diabetes.||
0642|015|U|Controlling high blood sugar helps prevent kidney damage,||
0642|016|U|blindness, nerve problems, loss of limbs, and sexual function||
0642|017|U|problems. Proper control of diabetes may also lessen your risk of||
0642|018|U|a heart attack or stroke.||
0642|019|U|   This insulin is obtained from pigs and is similar to human||
0642|020|U|insulin. It replaces the insulin that your body would normally||
0642|021|U|make. It is a short-acting insulin. It works by helping blood||
0642|022|U|sugar (glucose) get into cells so your body can use it for||
0642|023|U|energy. This medication is usually used in combination with a||
0642|024|U|medium- or long-acting insulin product. This medication may also||
0642|025|U|be used alone or with other oral diabetes drugs (such as||
0642|026|U|metformin).||
0642|027|B|||
0642|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0642|029|H|from your pharmacist before you start using this medication and||
0642|030|H|each time you get a refill. Ask your health care professional how||
0642|031|H|to prepare and use this medication. If you have any questions,||
0642|032|H|ask your doctor or pharmacist.||
0642|033|H|   Inject this medication under the skin as directed by your||
0642|034|H|doctor, usually within 30 to 60 minutes before a meal or||
0642|035|H|immediately after a meal. Because this insulin is fast-acting,||
0642|036|H|not eating right after a dose of this insulin may lead to low||
0642|037|H|blood sugar (hypoglycemia). The injection is given in the stomach||
0642|038|H|area, the thigh, the buttocks, or the back of the upper arm. Do||
0642|039|H|not inject into a vein because very low blood sugar may occur.||
0642|040|H|   The dosage is based on your medical condition and response to||
0642|041|H|treatment. Measure each dose very carefully because even small||
0642|042|H|changes in the amount of insulin may have a large effect on your||
0642|043|H|blood sugar.||
0642|044|H|   Before using, check this product for particles or||
0642|045|H|discoloration. If either is present, do not use the liquid.||
0642|046|H|Before injecting each dose, clean the skin you are going to||
0642|047|H|inject into (the injection site) with rubbing alcohol. Change the||
0642|048|H|injection site each time to lessen injury under the skin (for||
0642|049|H|example, pits/lumps or thickened skin). Do not inject into skin||
0642|050|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
0642|051|H|not rub the injection site after a shot. Do not inject cold||
0642|052|H|insulin because this can be painful. The insulin container you||
0642|053|H|are currently using can be kept at room temperature. Learn how to||
0642|054|H|store and discard medical supplies safely.||
0642|055|H|   Giving insulin regular into a vein should only be done by a||
0642|056|H|health care professional. Very low blood sugar may result.||
0642|057|H|   This product may be mixed only with certain other insulin||
0642|058|H|products such as NPH insulin (pork). Always draw the insulin||
0642|059|H|regular into the syringe first, then follow with the||
0642|060|H|longer-acting insulin. Never inject a mixture of different||
0642|061|H|insulins into a vein. Consult your health care professional about||
0642|062|H|which products may be mixed, the proper method for mixing||
0642|063|H|insulin, and the proper way to inject mixtures of insulin. Do not||
0642|064|H|mix insulins if you are using an insulin pump.||
0642|065|H|   Do not change brands or types of insulin without directions on||
0642|066|H|how to do so from your doctor.||
0642|067|H|   Use this medication regularly to get the most benefit from it.||
0642|068|H|To help you remember, use it at the same times each day.||
0642|069|H|   Tell your doctor if your condition does not get better or if||
0642|070|H|it gets worse (your blood sugar is too high or too low).||
0642|071|B|||
0642|072|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
0642|073|S|irritation) or weight gain may occur. If any of these effects||
0642|074|S|last or get worse, tell your doctor or pharmacist promptly.||
0642|075|S|   Remember that this medication has been prescribed because your||
0642|076|S|doctor has judged that the benefit to you is greater than the||
0642|077|S|risk of side effects. Many people using this medication do not||
0642|078|S|have serious side effects.||
0642|079|S|   Tell your doctor right away if you have any serious side||
0642|080|S|effects, including: signs of low potassium level in the blood||
0642|081|S|(such as muscle cramps, weakness, irregular heartbeat).||
0642|082|S|   This medication can cause low blood sugar (hypoglycemia). This||
0642|083|S|may occur if you do not get enough calories from food or if you||
0642|084|S|do unusually heavy exercise. Symptoms of low blood sugar include||
0642|085|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
0642|086|S|dizziness, or tingling hands/feet. It is a good habit to carry||
0642|087|S|glucose tablets or gel to treat low blood sugar. If you don't||
0642|088|S|have these reliable forms of glucose, rapidly raise your blood||
0642|089|S|sugar by eating a quick source of sugar such as table sugar,||
0642|090|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
0642|091|S|doctor right away about the reaction and the use of this product.||
0642|092|S|To help prevent low blood sugar, eat meals on a regular schedule,||
0642|093|S|and do not skip meals. Check with your doctor or pharmacist to||
0642|094|S|find out what you should do if you miss a meal.||
0642|095|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0642|096|S|thirst/urination. If these symptoms occur, tell your doctor right||
0642|097|S|away. Your doctor may need to adjust your diabetes medication,||
0642|098|S|exercise program, or diet.||
0642|099|S|   A very serious allergic reaction to this drug is rare.||
0642|100|S|However, get medical help right away if you notice any symptoms||
0642|101|S|of a serious allergic reaction, including: rash, itching/swelling||
0642|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0642|103|S|breathing.||
0642|104|S|   This is not a complete list of possible side effects. If you||
0642|105|S|notice other effects not listed above, contact your doctor or||
0642|106|S|pharmacist.||
0642|107|S|   In the US -||
0642|108|S|   Call your doctor for medical advice about side effects. You||
0642|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0642|110|S|www.fda.gov/medwatch.||
0642|111|S|   In Canada - Call your doctor for medical advice about side||
0642|112|S|effects. You may report side effects to Health Canada at||
0642|113|S|1-866-234-2345.||
0642|114|B|||
0642|115|P|PRECAUTIONS:  Before using insulin regular, tell your doctor or||
0642|116|P|pharmacist if you are allergic to it; or to pork; or to other||
0642|117|P|insulins; or if you have any other allergies. This product may||
0642|118|P|contain inactive ingredients, which can cause allergic reactions||
0642|119|P|or other problems. Talk to your pharmacist for more details.||
0642|120|P|   Do not use this medication when you have low blood sugar||
0642|121|P|(hypoglycemia).||
0642|122|P|   Before using this medication, tell your doctor or pharmacist||
0642|123|P|your medical history, especially of: kidney disease, liver||
0642|124|P|disease, thyroid problems.||
0642|125|P|   You may experience blurred vision, dizziness, or drowsiness||
0642|126|P|due to extremely low or high blood sugar. Do not drive, use||
0642|127|P|machinery, or do anything that needs alertness or clear vision||
0642|128|P|until you can do it safely.||
0642|129|P|   Limit alcohol while taking this medication because it can||
0642|130|P|increase your risk of developing low blood sugar.||
0642|131|P|   It may be harder to control your blood sugar when your body is||
0642|132|P|stressed (such as due to fever, infection, injury, or surgery).||
0642|133|P|Consult your doctor because this may require a change in your||
0642|134|P|treatment plan, medications, or blood sugar testing.||
0642|135|P|   Before having surgery, tell your doctor or dentist about all||
0642|136|P|the products you use (including prescription drugs,||
0642|137|P|nonprescription drugs, and herbal products).||
0642|138|P|   Check your blood sugar before and after exercise. You may need||
0642|139|P|a snack before exercising.||
0642|140|P|   If traveling across time zones, ask your doctor about how to||
0642|141|P|adjust your insulin schedule. Take extra insulin and supplies||
0642|142|P|with you.||
0642|143|P|   Older adults may be more sensitive to the side effects of this||
0642|144|P|drug, especially low blood sugar.||
0642|145|P|   Children may be more sensitive to the side effects of this||
0642|146|P|drug, especially low blood sugar.||
0642|147|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
0642|148|P|cause or worsen diabetes. Discuss a plan with your doctor for||
0642|149|P|managing your blood sugar while pregnant. Your doctor may change||
0642|150|P|your diabetes treatment during your pregnancy (such as diet and||
0642|151|P|medications including insulin).||
0642|152|P|   This medication passes into breast milk, but is unlikely to||
0642|153|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0642|154|P|Your insulin needs may change while breastfeeding.||
0642|155|B|||
0642|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0642|157|I|medications work or increase your risk for serious side effects.||
0642|158|I|This document does not contain all possible drug interactions.||
0642|159|I|Keep a list of all the products you use (including||
0642|160|I|prescription/nonprescription drugs and herbal products) and share||
0642|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
0642|162|I|the dosage of any medicines without your doctor's approval.||
0642|163|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0642|164|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0642|165|I|heartbeat you would usually feel when your blood sugar falls too||
0642|166|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0642|167|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0642|168|I|   Many drugs can affect your blood sugar levels, making it more||
0642|169|I|difficult to control your blood sugar. Before you start, stop, or||
0642|170|I|change any medication, talk with your doctor or pharmacist about||
0642|171|I|how the medication may affect your blood sugar. Check your blood||
0642|172|I|sugar regularly as directed by your doctor. Tell your doctor||
0642|173|I|about the results and of any symptoms of high or low blood sugar.||
0642|174|I|(See also Side Effects section.) Your doctor may need to adjust||
0642|175|I|your diabetes medication, exercise program, or diet.||
0642|176|B|||
0642|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0642|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0642|179|O|poison control center right away. US residents can call||
0642|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0642|181|O|Symptoms of overdose may include: signs of low blood sugar such||
0642|182|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
0642|183|B|||
0642|184|N|NOTES:  Do not share this medication, needles, or syringes with||
0642|185|N|others.||
0642|186|N|   Attend a diabetes education program to learn more about how to||
0642|187|N|manage your diabetes with medications, diet, exercise, and||
0642|188|N|regular medical exams.||
0642|189|N|   Learn the symptoms of high and low blood sugar and how to||
0642|190|N|treat low blood sugar. Check your blood sugar regularly as||
0642|191|N|directed and share the results with your doctor.||
0642|192|N|   Lab and/or medical tests (such as liver/kidney function,||
0642|193|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
0642|194|N|should be done while you are taking this medication. Keep all||
0642|195|N|medical and lab appointments.||
0642|196|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
0642|197|B|||
0642|198|D|MISSED DOSE:  It is very important to follow your insulin regimen||
0642|199|D|exactly. Ask your doctor ahead of time what you should do if you||
0642|200|D|miss a dose of insulin.||
0642|201|B|||
0642|202|R|STORAGE:  It is best to refrigerate all unopened insulin||
0642|203|R|products. Unopened insulin regular may also be stored at room||
0642|204|R|temperature, but it must be thrown away after 28 days. Opened||
0642|205|R|insulin regular vials may be stored in the refrigerator or at||
0642|206|R|room temperature. Throw away all insulin regular in use after 28||
0642|207|R|days, even if there is insulin left. Also throw away all insulin||
0642|208|R|products after the expiration date on the package. Do not freeze||
0642|209|R|and do not use insulin that has been frozen.||
0642|210|R|   Protect insulin from light and heat. Do not store in the||
0642|211|R|bathroom. Keep all medications away from children and pets.||
0642|212|R|   Do not flush medications down the toilet or pour them into a||
0642|213|R|drain unless instructed to do so. Properly discard this product||
0642|214|R|when it is expired or no longer needed. Consult your pharmacist||
0642|215|R|or local waste disposal company.||
0642|216|B|||
0642|217|M|MEDICAL ALERT:  Your condition can cause complications in a||
0642|218|M|medical emergency. For information about enrolling in MedicAlert,||
0642|219|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0642|220|B|||
0642|221|A|Information last revised April 2025.||
0642|222|A|Copyright(c) 2025 First Databank, Inc.||
0642|223|B|||
0643|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0643|002|Z|does NOT have all possible information about this product. This||
0643|003|Z|information does not assure that this product is safe, effective,||
0643|004|Z|or appropriate for you. This information is not individual||
0643|005|Z|medical advice and does not substitute for the advice of your||
0643|006|Z|health care professional. Always ask your health care||
0643|007|Z|professional for complete information about this product and your||
0643|008|Z|specific health needs.||
0643|009|B|||
0643|010|T|TOLNAFTATE - TOPICAL||
0643|011|F|(tole-NAF-tate)||
0643|012|B|||
0643|013|U|USES:  Tolnaftate is used to treat skin infections such as||
0643|014|U|athlete's foot, jock itch, and ringworm. It is an antifungal that||
0643|015|U|works by preventing the growth of fungus. Some forms of||
0643|016|U|tolnaftate may also be used to prevent athlete's foot from coming||
0643|017|U|back.||
0643|018|B|||
0643|019|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0643|020|H|thoroughly dry the area to be treated. Apply this medication to||
0643|021|H|the affected skin, usually twice a day or as directed on the||
0643|022|H|product package or by your doctor. The dosage and length of||
0643|023|H|treatment depends on the type of infection being treated.||
0643|024|H|   Some forms of tolnaftate (such as powder) need to be shaken||
0643|025|H|before applying. Check your product package to see if your form||
0643|026|H|of this medication needs to be shaken. Apply enough medication to||
0643|027|H|cover the affected area and some of the surrounding skin. After||
0643|028|H|applying this medication, wash your hands. Do not wrap, cover, or||
0643|029|H|bandage the area unless directed to do so by your doctor.||
0643|030|H|   Do not apply this medication in the eyes, nose, mouth, or||
0643|031|H|vagina.||
0643|032|H|   Use this medication regularly in order to get the most benefit||
0643|033|H|from it. Remember to use it at the same time(s) each day.||
0643|034|H|   Continue to use this medication until the full prescribed||
0643|035|H|amount is finished, even if symptoms disappear after a few days.||
0643|036|H|Stopping the medication too early may result in a return of the||
0643|037|H|infection.||
0643|038|H|   Tell your doctor if your condition lasts after 2 weeks of||
0643|039|H|treatment for jock itch, after 4 weeks of treatment for athlete's||
0643|040|H|foot or ringworm, or if your condition gets worse at any time.||
0643|041|B|||
0643|042|S|SIDE EFFECTS:  Irritation of the treated skin may occur. If this||
0643|043|S|effect lasts or gets worse, notify your doctor or pharmacist||
0643|044|S|promptly.||
0643|045|S|   If your doctor has directed you to use this medication,||
0643|046|S|remember that your doctor has judged that the benefit to you is||
0643|047|S|greater than the risk of side effects. Many people using this||
0643|048|S|medication do not have serious side effects.||
0643|049|S|   A very serious allergic reaction to this drug is rare.||
0643|050|S|However, get medical help right away if you notice any symptoms||
0643|051|S|of a serious allergic reaction, including: rash, itching/swelling||
0643|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0643|053|S|breathing.||
0643|054|S|   This is not a complete list of possible side effects. If you||
0643|055|S|notice other effects not listed above, contact your doctor or||
0643|056|S|pharmacist.||
0643|057|S|   In the US -||
0643|058|S|   Call your doctor for medical advice about side effects. You||
0643|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0643|060|S|www.fda.gov/medwatch.||
0643|061|S|   In Canada - Call your doctor for medical advice about side||
0643|062|S|effects. You may report side effects to Health Canada at||
0643|063|S|1-866-234-2345.||
0643|064|B|||
0643|065|P|PRECAUTIONS:  Before using tolnaftate, tell your doctor or||
0643|066|P|pharmacist if you are allergic to it; or if you have any other||
0643|067|P|allergies. This product may contain inactive ingredients, which||
0643|068|P|can cause allergic reactions or other problems. Talk to your||
0643|069|P|pharmacist for more details.||
0643|070|P|   Before using this medication, tell your doctor or pharmacist||
0643|071|P|your medical history.||
0643|072|P|   Before having surgery, tell your doctor or dentist about all||
0643|073|P|the products you use (including prescription drugs,||
0643|074|P|nonprescription drugs, and herbal products).||
0643|075|P|   This medication should be used only if clearly needed during||
0643|076|P|pregnancy. Discuss the risks and benefits with your doctor.||
0643|077|P|   It is unknown if this drug passes into breast milk. Consult||
0643|078|P|your doctor before breastfeeding.||
0643|079|B|||
0643|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0643|081|I|medications work or increase your risk for serious side effects.||
0643|082|I|This document does not contain all possible drug interactions.||
0643|083|I|Keep a list of all the products you use (including||
0643|084|I|prescription/nonprescription drugs and herbal products) and share||
0643|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
0643|086|I|the dosage of any medicines without your doctor's approval.||
0643|087|B|||
0643|088|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0643|089|O|has overdosed and has serious symptoms such as passing out or||
0643|090|O|trouble breathing, call 911. Otherwise, call a poison control||
0643|091|O|center right away. US residents can call 1-800-222-1222. Canada||
0643|092|O|residents can call 1-844-764-7669.||
0643|093|B|||
0643|094|N|NOTES:  Do not share this medication with others.||
0643|095|N|   This medication has been prescribed for your current condition||
0643|096|N|only. Do not use it later for another infection unless your||
0643|097|N|doctor tells you to.||
0643|098|B|||
0643|099|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0643|100|D|If it is near the time of the next dose, skip the missed dose.||
0643|101|D|Use your next dose at the regular time. Do not double the dose to||
0643|102|D|catch up.||
0643|103|B|||
0643|104|R|STORAGE:  Store at room temperature. Keep all medications away||
0643|105|R|from children and pets.||
0643|106|R|   Do not flush medications down the toilet or pour them into a||
0643|107|R|drain unless instructed to do so. Properly discard this product||
0643|108|R|when it is expired or no longer needed. Consult your pharmacist||
0643|109|R|or local waste disposal company.||
0643|110|B|||
0643|111|A|Information last revised May 2024.||
0643|112|A|Copyright(c) 2025 First Databank, Inc.||
0643|113|B|||
0644|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0644|002|Z|does NOT have all possible information about this product. This||
0644|003|Z|information does not assure that this product is safe, effective,||
0644|004|Z|or appropriate for you. This information is not individual||
0644|005|Z|medical advice and does not substitute for the advice of your||
0644|006|Z|health care professional. Always ask your health care||
0644|007|Z|professional for complete information about this product and your||
0644|008|Z|specific health needs.||
0644|009|B|||
0644|010|T|LACTASE ENZYME - ORAL||
0644|011|F|(LAK-tase)||
0644|012|B|||
0644|013|U|USES:  This product is an enzyme supplement used to help people||
0644|014|U|who have trouble digesting milk and other dairy products (lactose||
0644|015|U|intolerance). Lactose is a type of sugar found in milk products.||
0644|016|U|Lactase enzyme is normally produced by the body to help break||
0644|017|U|down (digest) lactose. Lactose intolerance occurs when the body||
0644|018|U|produces low amounts of lactase enzyme.||
0644|019|U|   Lactose intolerance can begin at different ages. Infants are||
0644|020|U|not usually affected, but lactose intolerance can affect children||
0644|021|U|as young as 2. It is very common in adults. One way to treat||
0644|022|U|lactose intolerance is to avoid milk products. However, this can||
0644|023|U|result in a lack of important nutrients and vitamins such as||
0644|024|U|calcium, vitamin D, riboflavin, and protein. Some people use||
0644|025|U|lactose-free milk or milk substitutes such as soy or rice milk.||
0644|026|U|Most people with low lactase enzyme levels can tolerate small||
0644|027|U|amounts of milk products at one time (2-4 ounces) and get||
0644|028|U|symptoms only with larger servings (6 ounces or more). Taking||
0644|029|U|lactase enzyme with milk products as directed can help prevent||
0644|030|U|upset stomach, abdominal bloating/cramping, gas, and diarrhea||
0644|031|U|caused by these products.||
0644|032|U|   The FDA has not reviewed this product for safety or||
0644|033|U|effectiveness. Consult your doctor or pharmacist for more||
0644|034|U|details.||
0644|035|B|||
0644|036|H|HOW TO USE:  Follow all directions on the product package. If||
0644|037|H|your doctor has prescribed this product, use it as directed. If||
0644|038|H|you have any questions, ask your doctor or pharmacist.||
0644|039|H|   If your condition lasts or gets worse, or if you think you may||
0644|040|H|have a serious medical problem, get medical help right away.||
0644|041|B|||
0644|042|S|SIDE EFFECTS:  This medication usually has very few side effects.||
0644|043|S|If you have any unusual effects from taking this medication,||
0644|044|S|contact your doctor or pharmacist promptly.||
0644|045|S|   If your doctor has directed you to use this medication,||
0644|046|S|remember that your doctor has judged that the benefit to you is||
0644|047|S|greater than the risk of side effects. Many people using this||
0644|048|S|medication do not have serious side effects.||
0644|049|S|   A very serious allergic reaction to this drug is rare.||
0644|050|S|However, get medical help right away if you notice any symptoms||
0644|051|S|of a serious allergic reaction, including: rash, itching/swelling||
0644|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0644|053|S|breathing.||
0644|054|S|   This is not a complete list of possible side effects. If you||
0644|055|S|notice other effects not listed above, contact your doctor or||
0644|056|S|pharmacist.||
0644|057|S|   In the US -||
0644|058|S|   Call your doctor for medical advice about side effects. You||
0644|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0644|060|S|www.fda.gov/medwatch.||
0644|061|S|   In Canada - Call your doctor for medical advice about side||
0644|062|S|effects. You may report side effects to Health Canada at||
0644|063|S|1-866-234-2345.||
0644|064|B|||
0644|065|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0644|066|P|pharmacist if you are allergic to it; or if you have any other||
0644|067|P|allergies. This product may contain inactive ingredients, which||
0644|068|P|can cause allergic reactions or other problems. Talk to your||
0644|069|P|pharmacist for more details.||
0644|070|P|   If you have any health problems, consult your doctor or||
0644|071|P|pharmacist before using this product.||
0644|072|P|   Before having surgery, tell your doctor or dentist about all||
0644|073|P|the products you use (including prescription drugs,||
0644|074|P|nonprescription drugs, and herbal products).||
0644|075|P|   It is unknown if this drug passes into breast milk. Consult||
0644|076|P|your doctor before breastfeeding.||
0644|077|B|||
0644|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0644|079|I|medications work or increase your risk for serious side effects.||
0644|080|I|This document does not contain all possible drug interactions.||
0644|081|I|Keep a list of all the products you use (including||
0644|082|I|prescription/nonprescription drugs and herbal products) and share||
0644|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
0644|084|I|the dosage of any medicines without your doctor's approval.||
0644|085|B|||
0644|086|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0644|087|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0644|088|O|poison control center right away. US residents can call||
0644|089|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0644|090|B|||
0644|091|N|NOTES:  Keep all medical and lab appointments.||
0644|092|N|   Read food labels. Lactose is also found in some non-milk||
0644|093|N|products.||
0644|094|B|||
0644|095|D|MISSED DOSE:  Not applicable.||
0644|096|B|||
0644|097|R|STORAGE:  Refer to storage information printed on the package. If||
0644|098|R|you have any questions about storage, ask your pharmacist. Keep||
0644|099|R|all products away from children and pets.||
0644|100|R|   Do not flush medications down the toilet or pour them into a||
0644|101|R|drain unless instructed to do so. Properly discard this product||
0644|102|R|when it is expired or no longer needed. Consult your pharmacist||
0644|103|R|or local waste disposal company.||
0644|104|B|||
0644|105|A|Information last revised May 2024.||
0644|106|A|Copyright(c) 2025 First Databank, Inc.||
0644|107|B|||
0646|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0646|002|Z|does NOT have all possible information about this product. This||
0646|003|Z|information does not assure that this product is safe, effective,||
0646|004|Z|or appropriate for you. This information is not individual||
0646|005|Z|medical advice and does not substitute for the advice of your||
0646|006|Z|health care professional. Always ask your health care||
0646|007|Z|professional for complete information about this product and your||
0646|008|Z|specific health needs.||
0646|009|B|||
0646|010|T|CORTISONE - ORAL||
0646|011|F|(KOR-ti-sone)||
0646|012|B|||
0646|013|C|COMMON BRAND NAME(S): Cortone||
0646|014|B|||
0646|015|U|USES:  Cortisone is a corticosteroid hormone (glucocorticoid). It||
0646|016|U|decreases your body's natural defensive response and reduces||
0646|017|U|symptoms such as swelling and allergic-type reactions.||
0646|018|U|   This medication is used to treat conditions such as arthritis,||
0646|019|U|blood/hormone/immune system disorders, allergic reactions,||
0646|020|U|certain skin and eye conditions, breathing problems, and certain||
0646|021|U|cancers.||
0646|022|B|||
0646|023|H|HOW TO USE:  Take this medication by mouth with food or milk to||
0646|024|H|prevent stomach upset. Take this medication by mouth with a full||
0646|025|H|glass of water (8 ounces/240 milliliters) unless your doctor||
0646|026|H|directs you otherwise. If you take this medication once daily,||
0646|027|H|take it in the morning before 9 AM. If you are taking this||
0646|028|H|medication every other day or on another schedule besides a daily||
0646|029|H|one, it may help to mark your calendar with a reminder.||
0646|030|H|   The dosage and length of treatment are based on your medical||
0646|031|H|condition and response to treatment. Use this medication||
0646|032|H|regularly in order to get the most benefit from it. To help you||
0646|033|H|remember, take it at the same time(s) each day. Keep taking this||
0646|034|H|medication even if you feel well. Follow the dosing schedule||
0646|035|H|carefully, and take this medication exactly as prescribed.||
0646|036|H|   Do not stop taking this medication without consulting your||
0646|037|H|doctor. Some conditions may become worse when this drug is||
0646|038|H|suddenly stopped. Your dose may need to be gradually decreased.||
0646|039|H|   Tell your doctor if your condition lasts or gets worse.||
0646|040|B|||
0646|041|S|SIDE EFFECTS:  Stomach upset, headache, dizziness, menstrual||
0646|042|S|changes (such as delayed/irregular/absent periods), trouble||
0646|043|S|sleeping, increased appetite, or weight gain may occur. If any of||
0646|044|S|these effects last or get worse, tell your doctor or pharmacist||
0646|045|S|promptly.||
0646|046|S|   Remember that this medication has been prescribed because your||
0646|047|S|doctor has judged that the benefit to you is greater than the||
0646|048|S|risk of side effects. Many people using this medication do not||
0646|049|S|have serious side effects.||
0646|050|S|   Tell your doctor right away if you have any serious side||
0646|051|S|effects, including: bone/joint pain, easy bruising/bleeding,||
0646|052|S|fast/pounding/irregular heartbeat, increased thirst/urination,||
0646|053|S|mental/mood changes (such as depression, mood swings, agitation),||
0646|054|S|muscle pain, ongoing weight gain, puffy face, slow wound healing,||
0646|055|S|seizures, signs of infection (such as sore throat that doesn't go||
0646|056|S|away, fever, chills), swelling of the ankles/feet, thinning skin,||
0646|057|S|unusual hair growth, unusual skin growths, vision changes,||
0646|058|S|symptoms of stomach/intestinal bleeding (such as||
0646|059|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
0646|060|S|coffee grounds), weakness, red/purple spots on the skin.||
0646|061|S|   A very serious allergic reaction to this drug is rare.||
0646|062|S|However, get medical help right away if you notice any symptoms||
0646|063|S|of a serious allergic reaction, including: rash, itching/swelling||
0646|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0646|065|S|breathing.||
0646|066|S|   This is not a complete list of possible side effects. If you||
0646|067|S|notice other effects not listed above, contact your doctor or||
0646|068|S|pharmacist.||
0646|069|S|   In the US -||
0646|070|S|   Call your doctor for medical advice about side effects. You||
0646|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0646|072|S|www.fda.gov/medwatch.||
0646|073|S|   In Canada - Call your doctor for medical advice about side||
0646|074|S|effects. You may report side effects to Health Canada at||
0646|075|S|1-866-234-2345.||
0646|076|B|||
0646|077|P|PRECAUTIONS:  Before taking cortisone, tell your doctor or||
0646|078|P|pharmacist if you are allergic to it; or to other corticosteroids||
0646|079|P|(such as prednisone); or if you have any other allergies. This||
0646|080|P|product may contain inactive ingredients, which can cause||
0646|081|P|allergic reactions or other problems. Talk to your pharmacist for||
0646|082|P|more details.||
0646|083|P|   Before using this medication, tell your doctor or pharmacist||
0646|084|P|your medical history, especially of: bleeding problems, history||
0646|085|P|of blood clots, brittle bones (osteoporosis), diabetes, eye||
0646|086|P|diseases (such as cataracts, glaucoma, herpes infection of the||
0646|087|P|eye), heart problems (such as heart failure), high blood||
0646|088|P|pressure, infections (such as fungal infections, tuberculosis,||
0646|089|P|herpes), kidney disease, liver problems (such as cirrhosis,||
0646|090|P|hepatitis B), mental/mood conditions (such as psychosis, anxiety,||
0646|091|P|depression), low blood minerals (such as low potassium or||
0646|092|P|calcium), stomach/intestinal problems (such as ulcer, ulcerative||
0646|093|P|colitis, diverticulitis), thyroid problems, a certain adrenal||
0646|094|P|gland tumor (pheochromocytoma).||
0646|095|P|   This medication may mask signs of infection. It can make you||
0646|096|P|more likely to get infections or may make current infections||
0646|097|P|worse. Stay away from anyone who has an infection that may easily||
0646|098|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0646|099|P|doctor if you have been exposed to an infection or for more||
0646|100|P|details.||
0646|101|P|   Using corticosteroid medications for a long time can make it||
0646|102|P|more difficult for your body to respond to physical stress.||
0646|103|P|Before having surgery or emergency treatment, or if you get a||
0646|104|P|serious illness/injury, tell your doctor or dentist that you are||
0646|105|P|using this medication or have used this medication within the||
0646|106|P|past 12 months. Tell your doctor right away if you develop||
0646|107|P|unusual/extreme tiredness or weight loss. If you will be using||
0646|108|P|this medication for a long time, carry a warning card or medical||
0646|109|P|ID bracelet that identifies your use of this medication.||
0646|110|P|   Tell your health care professional that you are using||
0646|111|P|cortisone before having any immunizations, vaccinations, or skin||
0646|112|P|tests. Avoid contact with people who have recently received live||
0646|113|P|vaccines (such as flu vaccine inhaled through the nose).||
0646|114|P|   If you have a history of ulcers or take large doses of aspirin||
0646|115|P|or other arthritis medication, limit alcoholic beverages while||
0646|116|P|taking this medication to decrease the risk of stomach/intestinal||
0646|117|P|bleeding.||
0646|118|P|   If you have diabetes, this drug may make it harder to control||
0646|119|P|your blood sugar levels. Monitor your blood sugar levels||
0646|120|P|regularly and inform your doctor of the results. Your medicine,||
0646|121|P|exercise plan, or diet may need to be adjusted.||
0646|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0646|123|P|can make you more dizzy. Do not drive, use machinery, or do||
0646|124|P|anything that needs alertness until you can do it safely. Limit||
0646|125|P|alcoholic beverages. Talk to your doctor if you are using||
0646|126|P|marijuana (cannabis).||
0646|127|P|   Older adults may be more sensitive to the side effects of this||
0646|128|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
0646|129|P|mental/mood changes (such as confusion).||
0646|130|P|   This medication may slow down a child's growth if used for a||
0646|131|P|long time. Consult the doctor or pharmacist for more details. See||
0646|132|P|the doctor regularly so your child's height and growth can be||
0646|133|P|checked.||
0646|134|P|   During pregnancy, this medication should be used only when||
0646|135|P|clearly needed. There have been rare reports of harm to the||
0646|136|P|unborn baby. Infants born to mothers who have been using this||
0646|137|P|medication for an extended time may have low levels of||
0646|138|P|corticosteroid hormone. Discuss the risks and benefits with your||
0646|139|P|doctor. Tell your doctor right away if you notice symptoms such||
0646|140|P|as nausea/vomiting that doesn't stop, severe diarrhea, or||
0646|141|P|weakness in your newborn.||
0646|142|P|   It is unknown if this drug passes into breast milk. Consult||
0646|143|P|your doctor before breastfeeding.||
0646|144|B|||
0646|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0646|146|I|medications work or increase your risk for serious side effects.||
0646|147|I|This document does not contain all possible drug interactions.||
0646|148|I|Keep a list of all the products you use (including||
0646|149|I|prescription/nonprescription drugs and herbal products) and share||
0646|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
0646|151|I|the dosage of any medicines without your doctor's approval.||
0646|152|I|   Some products that may interact with this drug are:||
0646|153|I|aldesleukin, birth control pills, desmopressin, diabetes||
0646|154|I|medications, estrogen hormone replacement, mifepristone, drugs||
0646|155|I|that can cause bleeding/bruising (including antiplatelet drugs||
0646|156|I|such as clopidogrel, "blood thinners" such as||
0646|157|I|dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen).||
0646|158|I|   If your doctor has told you to take low-dose aspirin to||
0646|159|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0646|160|I|you should keep taking the aspirin unless your doctor tells you||
0646|161|I|not to. Ask your doctor or pharmacist for more details.||
0646|162|I|   Other medications can affect the removal of cortisone from||
0646|163|I|your body, which may affect how cortisone works. Examples include||
0646|164|I|azole antifungals (such as ketoconazole), rifamycins (such as||
0646|165|I|rifabutin), drugs used to treat seizures (such as phenytoin),||
0646|166|I|among others.||
0646|167|I|   This medication may interfere with certain lab tests, possibly||
0646|168|I|causing false test results. Make sure lab personnel and all your||
0646|169|I|doctors know you use this drug.||
0646|170|B|||
0646|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0646|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0646|173|O|poison control center right away. US residents can call||
0646|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0646|175|B|||
0646|176|N|NOTES:  Do not share this medication with others.||
0646|177|N|   If this medication is used for a long time, lab and/or medical||
0646|178|N|tests (such as blood sugar/mineral levels, blood pressure, eye||
0646|179|N|exams) should be done while you are taking this medication. Keep||
0646|180|N|all medical and lab appointments. Consult your doctor for more||
0646|181|N|details.||
0646|182|N|   This medication may cause bone loss (osteoporosis) when used||
0646|183|N|for a long time. Lifestyle changes that may help reduce the risk||
0646|184|N|of bone problems include doing weight-bearing exercise, stopping||
0646|185|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
0646|186|N|D. Talk to your doctor for more details.||
0646|187|B|||
0646|188|D|MISSED DOSE:  If you are taking this medication once daily and||
0646|189|D|miss a dose, take it as soon as you remember. If it is near the||
0646|190|D|time of the next dose, skip the missed dose. Take your next dose||
0646|191|D|at the regular time. Do not double the dose to catch up.||
0646|192|D|   Ask your doctor ahead of time what you should do if you miss a||
0646|193|D|dose while taking this medication every other day or on another||
0646|194|D|schedule besides a daily one.||
0646|195|B|||
0646|196|R|STORAGE:  Store at room temperature away from light and moisture.||
0646|197|R|Do not store in the bathroom. Keep all medications away from||
0646|198|R|children and pets.||
0646|199|R|   Do not flush medications down the toilet or pour them into a||
0646|200|R|drain unless instructed to do so. Properly discard this product||
0646|201|R|when it is expired or no longer needed. Consult your pharmacist||
0646|202|R|or local waste disposal company.||
0646|203|B|||
0646|204|M|MEDICAL ALERT:  Your condition can cause complications in a||
0646|205|M|medical emergency. For information about enrolling in MedicAlert,||
0646|206|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0646|207|B|||
0646|208|A|Information last revised September 2025.||
0646|209|A|Copyright(c) 2025 First Databank, Inc.||
0646|210|B|||
0647|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0647|002|Z|does NOT have all possible information about this product. This||
0647|003|Z|information does not assure that this product is safe, effective,||
0647|004|Z|or appropriate for you. This information is not individual||
0647|005|Z|medical advice and does not substitute for the advice of your||
0647|006|Z|health care professional. Always ask your health care||
0647|007|Z|professional for complete information about this product and your||
0647|008|Z|specific health needs.||
0647|009|B|||
0647|010|T|TRIAMCINOLONE - TOPICAL||
0647|011|F|(trye-am-SIN-oh-lone)||
0647|012|B|||
0647|013|C|COMMON BRAND NAME(S): Aristocort, Aristocort HP, Kenalog, Triderm||
0647|014|B|||
0647|015|U|USES:  This medication is used to treat a variety of skin||
0647|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0647|017|U|Triamcinolone reduces the swelling, itching, and redness that can||
0647|018|U|occur in these types of conditions. This medication is a medium-||
0647|019|U|to strong-potency corticosteroid. The potency depends on the||
0647|020|U|strength and the form that you use. For details on the potency of||
0647|021|U|your product, ask your pharmacist.||
0647|022|B|||
0647|023|H|HOW TO USE:  Use this medication only on the skin. Do not use it||
0647|024|H|on the face, groin, or underarms unless directed to do so by your||
0647|025|H|doctor.||
0647|026|H|   Wash and dry your hands. Before applying the medication, clean||
0647|027|H|and dry the affected area. Apply a thin film of the medication to||
0647|028|H|the affected area and gently rub in as directed by your doctor,||
0647|029|H|usually 2 to 4 times daily. Do not cover, bandage or wrap the||
0647|030|H|area unless directed to do so by your doctor.||
0647|031|H|   After applying the medication, wash your hands unless you are||
0647|032|H|using this medication to treat the hands. When applying this||
0647|033|H|medication near the eyes, avoid getting it in the eyes as this||
0647|034|H|may worsen or cause glaucoma. Also, avoid getting this medication||
0647|035|H|in the nose or mouth. If you get the medication in your eyes,||
0647|036|H|nose, or mouth, rinse with plenty of water.||
0647|037|H|   Use this medication only for the condition prescribed. Do not||
0647|038|H|use it for longer than prescribed.||
0647|039|H|   Tell your doctor if your condition lasts or gets worse.||
0647|040|B|||
0647|041|S|SIDE EFFECTS:  Burning, itching, irritation, or dryness may occur||
0647|042|S|when this medication is first applied to the skin. This should||
0647|043|S|disappear in a few days as your body adjusts to the medication.||
0647|044|S|If any of these effects last or get worse, notify your doctor or||
0647|045|S|pharmacist promptly.||
0647|046|S|   Remember that this medication has been prescribed because your||
0647|047|S|doctor has judged that the benefit to you is greater than the||
0647|048|S|risk of side effects. Many people using this medication do not||
0647|049|S|have serious side effects.||
0647|050|S|   Tell your doctor right away if you have any serious side||
0647|051|S|effects, including: stretch marks, skin thinning/discoloration,||
0647|052|S|acne, greatly increased hair growth, small red bumps on the skin||
0647|053|S|(folliculitis).||
0647|054|S|   Skin infections can become worse when this medication is used.||
0647|055|S|Notify your doctor if redness, swelling, or irritation do not||
0647|056|S|improve.||
0647|057|S|   Rarely, it is possible this medication will be absorbed from||
0647|058|S|the skin into the bloodstream. This can lead to side effects of||
0647|059|S|too much corticosteroid. These side effects are more likely in||
0647|060|S|children, and in people who use this medication for a long time||
0647|061|S|or over large areas of the skin. Tell your doctor right away if||
0647|062|S|any of the following side effects occur: unusual/extreme||
0647|063|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0647|064|S|thirst/urination, vision problems.||
0647|065|S|   A very serious allergic reaction to this drug is rare.||
0647|066|S|However, get medical help right away if you notice any symptoms||
0647|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0647|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0647|069|S|breathing.||
0647|070|S|   This is not a complete list of possible side effects. If you||
0647|071|S|notice other effects not listed above, contact your doctor or||
0647|072|S|pharmacist.||
0647|073|S|   In the US -||
0647|074|S|   Call your doctor for medical advice about side effects. You||
0647|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0647|076|S|www.fda.gov/medwatch.||
0647|077|S|   In Canada - Call your doctor for medical advice about side||
0647|078|S|effects. You may report side effects to Health Canada at||
0647|079|S|1-866-234-2345.||
0647|080|B|||
0647|081|P|PRECAUTIONS:  Before using triamcinolone, tell your doctor or||
0647|082|P|pharmacist if you are allergic to it; or to other corticosteroids||
0647|083|P|(such as hydrocortisone, prednisone); or if you have any other||
0647|084|P|allergies. This product may contain inactive ingredients, which||
0647|085|P|can cause allergic reactions or other problems. Talk to your||
0647|086|P|pharmacist for more details.||
0647|087|P|   Before using this medication, tell your doctor or pharmacist||
0647|088|P|your medical history, especially of: poor blood circulation,||
0647|089|P|immune system problems.||
0647|090|P|   Do not use if there is an infection or sore present in the||
0647|091|P|area to be treated.||
0647|092|P|   Rarely, using corticosteroid medications for a long time or||
0647|093|P|over large areas of skin can make it more difficult for your body||
0647|094|P|to respond to physical stress. Before having surgery or emergency||
0647|095|P|treatment, or if you get a serious illness/injury, tell your||
0647|096|P|doctor or dentist that you are using this medication or have used||
0647|097|P|this medication within the past few months.||
0647|098|P|   Though it is unlikely, this medication may temporarily slow||
0647|099|P|down a child's growth if used for a long time. See the doctor||
0647|100|P|regularly so your child's height can be checked.||
0647|101|P|   During pregnancy, this medication should be used only when||
0647|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0647|103|P|   It is unknown if this drug passes into breast milk when||
0647|104|P|applied to the skin. Other medications in this class pass into||
0647|105|P|breast milk when taken by mouth. Consult your doctor before||
0647|106|P|breastfeeding.||
0647|107|B|||
0647|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0647|109|I|medications work or increase your risk for serious side effects.||
0647|110|I|This document does not contain all possible drug interactions.||
0647|111|I|Keep a list of all the products you use (including||
0647|112|I|prescription/nonprescription drugs and herbal products) and share||
0647|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
0647|114|I|the dosage of any medicines without your doctor's approval.||
0647|115|B|||
0647|116|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0647|117|O|has overdosed and has serious symptoms such as passing out or||
0647|118|O|trouble breathing, call 911. Otherwise, call a poison control||
0647|119|O|center right away. US residents can call 1-800-222-1222. Canada||
0647|120|O|residents can call 1-844-764-7669.||
0647|121|B|||
0647|122|N|NOTES:  Do not share this medication with others.||
0647|123|N|   This medication has been prescribed for your current condition||
0647|124|N|only. Do not use it later for other skin problems unless told to||
0647|125|N|do so by your doctor. A different medication may be necessary in||
0647|126|N|those cases.||
0647|127|N|   Lab and/or medical tests (such as adrenal gland function) may||
0647|128|N|be done while you are using this medication, especially if you||
0647|129|N|use this drug for an extended period of time or apply it over||
0647|130|N|large areas of the body. Keep all medical and lab appointments.||
0647|131|N|Consult your doctor for more details.||
0647|132|B|||
0647|133|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0647|134|D|If it is near the time of the next dose, skip the missed dose.||
0647|135|D|Use your next dose at the regular time. Do not double the dose to||
0647|136|D|catch up.||
0647|137|B|||
0647|138|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
0647|139|R|medications away from children and pets.||
0647|140|R|   Do not flush medications down the toilet or pour them into a||
0647|141|R|drain unless instructed to do so. Properly discard this product||
0647|142|R|when it is expired or no longer needed. Consult your pharmacist||
0647|143|R|or local waste disposal company.||
0647|144|B|||
0647|145|A|Information last revised October 2024.||
0647|146|A|Copyright(c) 2025 First Databank, Inc.||
0647|147|B|||
0650|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0650|002|Z|does NOT have all possible information about this product. This||
0650|003|Z|information does not assure that this product is safe, effective,||
0650|004|Z|or appropriate for you. This information is not individual||
0650|005|Z|medical advice and does not substitute for the advice of your||
0650|006|Z|health care professional. Always ask your health care||
0650|007|Z|professional for complete information about this product and your||
0650|008|Z|specific health needs.||
0650|009|B|||
0650|010|T|POTASSIUM SOLUTION/POWDER FOR SOLUTION - ORAL||
0650|011|F|(poe-TAS-ee-um)||
0650|012|B|||
0650|013|C|COMMON BRAND NAME(S): Klor-Con, Pokonza||
0650|014|B|||
0650|015|U|USES:  This medication is a mineral supplement used to treat or||
0650|016|U|prevent low amounts of potassium in the blood. A normal level of||
0650|017|U|potassium in the blood is important. Potassium helps your cells,||
0650|018|U|kidneys, heart, muscles, and nerves work properly. Most people||
0650|019|U|get enough potassium by eating a well-balanced diet. Some||
0650|020|U|conditions that can lower your body's potassium level include||
0650|021|U|severe prolonged diarrhea and vomiting, hormone problems such as||
0650|022|U|hyperaldosteronism, or treatment with "water pills"/diuretics.||
0650|023|B|||
0650|024|H|HOW TO USE:  To prevent stomach upset, you must first mix your||
0650|025|H|dose of potassium with a glass (4 to 8 ounces/120 to 240||
0650|026|H|milliliters) of cold water as directed by your doctor. Some||
0650|027|H|brands may also be mixed with juice. If you are using the liquid||
0650|028|H|form of this medication, carefully measure the dose using a||
0650|029|H|special measuring device/spoon. Do not use a household spoon||
0650|030|H|because you may not get the correct dose. After mixing, slowly||
0650|031|H|drink the entire mixture. Take each dose with a meal or||
0650|032|H|immediately after a meal. If you have upset stomach, mixing your||
0650|033|H|dose in a larger amount of liquid may help. If you have any||
0650|034|H|questions, ask your doctor or pharmacist.||
0650|035|H|   Take this medication regularly to get the most benefit from||
0650|036|H|it. To help you remember, take it at the same time(s) each day.||
0650|037|H|The dosage is based on your medical condition and response to||
0650|038|H|treatment. Do not increase your dose or take it more often than||
0650|039|H|prescribed.||
0650|040|H|   Tell your doctor if your condition does not get better or if||
0650|041|H|you have symptoms of low potassium in the blood (such as||
0650|042|H|irregular heartbeat, muscle weakness/cramps).||
0650|043|B|||
0650|044|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, gas, or diarrhea||
0650|045|S|may occur. If any of these effects last or get worse, tell your||
0650|046|S|doctor or pharmacist promptly.||
0650|047|S|   Remember that this medication has been prescribed because your||
0650|048|S|doctor has judged that the benefit to you is greater than the||
0650|049|S|risk of side effects. Many people using this medication do not||
0650|050|S|have serious side effects.||
0650|051|S|   Get medical help right away if you have any very serious side||
0650|052|S|effects, including: vomit that looks like coffee grounds,||
0650|053|S|stomach/abdominal pain, black/tarry stools.||
0650|054|S|   A very serious allergic reaction to this drug is rare.||
0650|055|S|However, get medical help right away if you notice any symptoms||
0650|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0650|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0650|058|S|breathing.||
0650|059|S|   This is not a complete list of possible side effects. If you||
0650|060|S|notice other effects not listed above, contact your doctor or||
0650|061|S|pharmacist.||
0650|062|S|   In the US -||
0650|063|S|   Call your doctor for medical advice about side effects. You||
0650|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0650|065|S|www.fda.gov/medwatch.||
0650|066|S|   In Canada - Call your doctor for medical advice about side||
0650|067|S|effects. You may report side effects to Health Canada at||
0650|068|S|1-866-234-2345.||
0650|069|B|||
0650|070|P|PRECAUTIONS:  Before taking potassium, tell your doctor or||
0650|071|P|pharmacist if you have any allergies. This product may contain||
0650|072|P|inactive ingredients, which can cause allergic reactions or other||
0650|073|P|problems. Talk to your pharmacist for more details.||
0650|074|P|   Before using this medication, tell your doctor or pharmacist||
0650|075|P|your medical history, especially of: heart problems, kidney||
0650|076|P|problems, high levels of potassium in the blood,||
0650|077|P|throat/stomach/intestinal problems (such as blockage, narrowing,||
0650|078|P|ulcers).||
0650|079|P|   Liquid products may contain alcohol, sugar, or aspartame.||
0650|080|P|Caution is advised if you have diabetes, liver disease,||
0650|081|P|phenylketonuria (PKU), or any other condition that requires you||
0650|082|P|to limit/avoid these substances in your diet.||
0650|083|P|   Before having surgery, tell your doctor or dentist about all||
0650|084|P|the products you use (including prescription drugs,||
0650|085|P|nonprescription drugs, and herbal products).||
0650|086|P|   Before using other potassium supplements or salt substitutes||
0650|087|P|that contain potassium, consult your doctor or pharmacist. Too||
0650|088|P|much potassium may cause serious side effects. (See also Overdose||
0650|089|P|section.)||
0650|090|P|   During pregnancy, this medication should be used only when||
0650|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
0650|092|P|   Potassium passes into breast milk. Consult your doctor before||
0650|093|P|breastfeeding.||
0650|094|B|||
0650|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0650|096|I|medications work or increase your risk for serious side effects.||
0650|097|I|This document does not contain all possible drug interactions.||
0650|098|I|Keep a list of all the products you use (including||
0650|099|I|prescription/nonprescription drugs and herbal products) and share||
0650|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
0650|101|I|the dosage of any medicines without your doctor's approval.||
0650|102|I|   Tell your doctor or pharmacist if you are regularly taking||
0650|103|I|other medications that can also raise your potassium level.||
0650|104|I|Examples include drospirenone, eplerenone, ACE inhibitors (such||
0650|105|I|as enalapril, lisinopril), angiotensin receptor blockers (such as||
0650|106|I|losartan, valsartan), potassium-sparing "water pills"/diuretics||
0650|107|I|(such as spironolactone, triamterene), among others.||
0650|108|B|||
0650|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0650|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0650|111|O|poison control center right away. US residents can call||
0650|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0650|113|O|Symptoms of overdose may include irregular heartbeat, muscle||
0650|114|O|weakness, confusion.||
0650|115|B|||
0650|116|N|NOTES:  Do not share this medication with others.||
0650|117|N|   Lab and/or medical tests (such as potassium blood level,||
0650|118|N|kidney function) should be done while you are taking this||
0650|119|N|medication. Keep all medical and lab appointments. Consult your||
0650|120|N|doctor for more details.||
0650|121|N|   Eat a well-balanced diet. Foods high in potassium include||
0650|122|N|bananas, oranges, cantaloupe, raisins, dates, prunes, avocados,||
0650|123|N|apricots, beans, broccoli, spinach, potatoes, lentils, chicken,||
0650|124|N|turkey, beef, and yogurt. Consult your doctor or dietician for||
0650|125|N|recommended foods.||
0650|126|B|||
0650|127|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0650|128|D|remember. If it is near the time of the next dose, skip the||
0650|129|D|missed dose. Take your next dose at the regular time. Do not||
0650|130|D|double the dose to catch up.||
0650|131|B|||
0650|132|R|STORAGE:  Store at room temperature away from light and moisture.||
0650|133|R|Do not freeze. Do not store in the bathroom. Keep all medications||
0650|134|R|away from children and pets.||
0650|135|R|   Do not flush medications down the toilet or pour them into a||
0650|136|R|drain unless instructed to do so. Properly discard this product||
0650|137|R|when it is expired or no longer needed. Consult your pharmacist||
0650|138|R|or local waste disposal company.||
0650|139|B|||
0650|140|A|Information last revised November 2024.||
0650|141|A|Copyright(c) 2025 First Databank, Inc.||
0650|142|B|||
0651|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0651|002|Z|does NOT have all possible information about this product. This||
0651|003|Z|information does not assure that this product is safe, effective,||
0651|004|Z|or appropriate for you. This information is not individual||
0651|005|Z|medical advice and does not substitute for the advice of your||
0651|006|Z|health care professional. Always ask your health care||
0651|007|Z|professional for complete information about this product and your||
0651|008|Z|specific health needs.||
0651|009|B|||
0651|010|T|DOXAZOSIN EXTENDED-RELEASE TABLET - ORAL||
0651|011|F|(dox-AZE-oh-sin)||
0651|012|B|||
0651|013|C|COMMON BRAND NAME(S): Cardura XL||
0651|014|B|||
0651|015|U|USES:  Doxazosin is used in men to treat the symptoms of an||
0651|016|U|enlarged prostate (benign prostatic hyperplasia-BPH). It does not||
0651|017|U|shrink the prostate, but it works by relaxing the muscles in the||
0651|018|U|prostate and part of the bladder. This helps to relieve symptoms||
0651|019|U|of BPH such as difficulty in beginning the flow of urine, weak||
0651|020|U|stream, and the need to urinate often or urgently (including||
0651|021|U|during the middle of the night).||
0651|022|U|   Doxazosin belongs to a class of drugs known as alpha blockers.||
0651|023|U|   This medication should not be used to treat high blood||
0651|024|U|pressure.||
0651|025|B|||
0651|026|V|OTHER USES:  This section contains uses of this drug that are not||
0651|027|V|listed in the approved professional labeling for the drug but||
0651|028|V|that may be prescribed by your health care professional. Use this||
0651|029|V|drug for a condition that is listed in this section only if it||
0651|030|V|has been so prescribed by your health care professional.||
0651|031|V|   This drug may also be used to help your body "pass," or get||
0651|032|V|rid of, kidney stones through urination. It may also be used for||
0651|033|V|bladder problems in women.||
0651|034|B|||
0651|035|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0651|036|H|from your pharmacist before you start taking doxazosin and each||
0651|037|H|time you get a refill. If you have any questions, ask your doctor||
0651|038|H|or pharmacist.||
0651|039|H|   Take this medication by mouth as directed by your doctor,||
0651|040|H|usually once daily with breakfast.||
0651|041|H|   Doxazosin may cause a sudden drop in your blood pressure,||
0651|042|H|which could lead to dizziness or fainting, usually within a few||
0651|043|H|hours after you take it. This risk is higher when you first start||
0651|044|H|taking this drug, after your doctor increases your dose, or if||
0651|045|H|you restart treatment after you stop taking it. During these||
0651|046|H|times, avoid situations where you may be injured if you faint.||
0651|047|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
0651|048|H|Doing so can release all of the drug at once, increasing the risk||
0651|049|H|of side effects.||
0651|050|H|   The dosage is based on your medical condition and response to||
0651|051|H|treatment.||
0651|052|H|   Take this medication regularly to get the most benefit from||
0651|053|H|it. To help you remember, take it at the same time each day. If||
0651|054|H|you miss taking doxazosin for a few days, you may need to restart||
0651|055|H|treatment at a lower dose and gradually increase your dose again.||
0651|056|H|Consult your doctor for more details.||
0651|057|H|   If you are switching from another form of doxazosin to this||
0651|058|H|extended-release form, be sure to follow your doctor's||
0651|059|H|instructions closely.||
0651|060|H|   Tell your doctor if your condition does not get better or if||
0651|061|H|it gets worse.||
0651|062|B|||
0651|063|S|SIDE EFFECTS:  Dizziness, lightheadedness, or drowsiness may||
0651|064|S|occur. If any of these effects last or get worse, tell your||
0651|065|S|doctor or pharmacist promptly.||
0651|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
0651|067|S|slowly when rising from a sitting or lying position.||
0651|068|S|   An empty tablet shell may appear in your stool. This effect is||
0651|069|S|harmless because your body has already absorbed the medication.||
0651|070|S|   Remember that this medication has been prescribed because your||
0651|071|S|doctor has judged that the benefit to you is greater than the||
0651|072|S|risk of side effects. Many people using this medication do not||
0651|073|S|have serious side effects.||
0651|074|S|   Tell your doctor right away if you have any serious side||
0651|075|S|effects, including: signs of infection (such as sore throat that||
0651|076|S|doesn't go away, fever, chills), fainting, shortness of breath,||
0651|077|S|weakness.||
0651|078|S|   Get medical help right away if you have any very serious side||
0651|079|S|effects, including: chest pain.||
0651|080|S|   Rarely, males may have a painful or prolonged erection lasting||
0651|081|S|4 or more hours. If this occurs, stop using this drug and get||
0651|082|S|medical help right away, or permanent problems could occur.||
0651|083|S|   A very serious allergic reaction to this drug is rare.||
0651|084|S|However, get medical help right away if you notice any symptoms||
0651|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0651|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0651|087|S|breathing.||
0651|088|S|   This is not a complete list of possible side effects. If you||
0651|089|S|notice other effects not listed above, contact your doctor or||
0651|090|S|pharmacist.||
0651|091|S|   In the US -||
0651|092|S|   Call your doctor for medical advice about side effects. You||
0651|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0651|094|S|www.fda.gov/medwatch.||
0651|095|S|   In Canada - Call your doctor for medical advice about side||
0651|096|S|effects. You may report side effects to Health Canada at||
0651|097|S|1-866-234-2345.||
0651|098|B|||
0651|099|P|PRECAUTIONS:  Before taking doxazosin, tell your doctor or||
0651|100|P|pharmacist if you are allergic to it; or to other alpha blockers||
0651|101|P|such as prazosin or terazosin; or if you have any other||
0651|102|P|allergies. This product may contain inactive ingredients, which||
0651|103|P|can cause allergic reactions or other problems. Talk to your||
0651|104|P|pharmacist for more details.||
0651|105|P|   Before using this medication, tell your doctor or pharmacist||
0651|106|P|your medical history, especially of: stomach/intestine problems||
0651|107|P|(such as short bowel syndrome, chronic constipation, narrow gut,||
0651|108|P|slow gut movement), heart disease (such as heart failure, angina,||
0651|109|P|heart attack in last 6 months), liver disease, low blood||
0651|110|P|pressure, certain eye problems (cataracts, glaucoma).||
0651|111|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0651|112|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0651|113|P|machinery, or do anything that needs alertness until you can do||
0651|114|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0651|115|P|are using marijuana (cannabis). See also How to Use section.||
0651|116|P|   Before having surgery (including cataract/glaucoma eye||
0651|117|P|surgery), tell your doctor or dentist if you are taking or have||
0651|118|P|ever taken this medication, and about all the other products you||
0651|119|P|use (including prescription drugs, nonprescription drugs, and||
0651|120|P|herbal products).||
0651|121|P|   Older adults may be more sensitive to the side effects of this||
0651|122|P|drug, especially dizziness and low blood pressure when getting up||
0651|123|P|from a sitting or lying position. These side effects can increase||
0651|124|P|the risk of falling.||
0651|125|P|   During pregnancy, this medication should be used only when||
0651|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
0651|127|P|   This medication passes into breast milk. Consult your doctor||
0651|128|P|before breastfeeding.||
0651|129|B|||
0651|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0651|131|I|medications work or increase your risk for serious side effects.||
0651|132|I|This document does not contain all possible drug interactions.||
0651|133|I|Keep a list of all the products you use (including||
0651|134|I|prescription/nonprescription drugs and herbal products) and share||
0651|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
0651|136|I|the dosage of any medicines without your doctor's approval.||
0651|137|I|   Some products that may interact with this drug include: other||
0651|138|I|alpha blocker drugs (such as prazosin, tamsulosin).||
0651|139|I|   If you are also taking a drug to treat erectile dysfunction-ED||
0651|140|I|or pulmonary hypertension (such as sildenafil, tadalafil), your||
0651|141|I|blood pressure may get too low which can lead to dizziness or||
0651|142|I|fainting. Your doctor may need to adjust your medications to||
0651|143|I|minimize this risk.||
0651|144|I|   Other medications can affect the removal of doxazosin from||
0651|145|I|your body, which may affect how doxazosin works. Examples include||
0651|146|I|azole antifungals (such as itraconazole, ketoconazole), macrolide||
0651|147|I|antibiotics (such as clarithromycin), HIV protease inhibitors||
0651|148|I|(such as lopinavir), ritonavir, among others.||
0651|149|B|||
0651|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0651|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0651|152|O|poison control center right away. US residents can call||
0651|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0651|154|O|Symptoms of overdose may include: severe dizziness, fainting.||
0651|155|B|||
0651|156|N|NOTES:  Do not share this medication with others.||
0651|157|N|   Lab and/or medical tests (such as prostate exams, blood||
0651|158|N|pressure) should be done while you are taking this medication.||
0651|159|N|Keep all medical and lab appointments. Consult your doctor for||
0651|160|N|more details.||
0651|161|B|||
0651|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0651|163|D|remember. If it is near the time of the next dose, skip the||
0651|164|D|missed dose. Take your next dose at the regular time. Do not||
0651|165|D|double the dose to catch up. See also How to Use section.||
0651|166|B|||
0651|167|R|STORAGE:  Store at room temperature away from light and moisture.||
0651|168|R|Do not store in the bathroom. Keep all medications away from||
0651|169|R|children and pets.||
0651|170|R|   Do not flush medications down the toilet or pour them into a||
0651|171|R|drain unless instructed to do so. Properly discard this product||
0651|172|R|when it is expired or no longer needed. Consult your pharmacist||
0651|173|R|or local waste disposal company.||
0651|174|B|||
0651|175|A|Information last revised April 2025.||
0651|176|A|Copyright(c) 2025 First Databank, Inc.||
0651|177|B|||
0656|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0656|002|Z|does NOT have all possible information about this product. This||
0656|003|Z|information does not assure that this product is safe, effective,||
0656|004|Z|or appropriate for you. This information is not individual||
0656|005|Z|medical advice and does not substitute for the advice of your||
0656|006|Z|health care professional. Always ask your health care||
0656|007|Z|professional for complete information about this product and your||
0656|008|Z|specific health needs.||
0656|009|B|||
0656|010|T|ETHINYL ESTRADIOL/DROSPIRENONE 24/4 - ORAL||
0656|011|F|(ETH-in-il ess-tra-DYE-ole/dro-SPY-re-nown)||
0656|012|B|||
0656|013|C|COMMON BRAND NAME(S): Yaz||
0656|014|B|||
0656|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
0656|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
0656|017|W|stroke, heart attack, blood clots, and high blood pressure from||
0656|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
0656|019|W|of these serious problems increases with age and with the number||
0656|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
0656|021|B|||
0656|022|U|USES:  This medication is a combination of 2 hormones: an||
0656|023|U|estrogen (ethinyl estradiol) and a progestin (drospirenone). This||
0656|024|U|product is used to prevent pregnancy.||
0656|025|U|   This medication also may be used to treat premenstrual||
0656|026|U|dysphoric disorder (PMDD) or moderate acne if you have chosen to||
0656|027|U|use birth control pills as your method of pregnancy prevention.||
0656|028|U|   Besides preventing pregnancy, birth control pills may make||
0656|029|U|your periods more regular, decrease blood loss and painful||
0656|030|U|periods, and decrease your risk of ovarian cysts.||
0656|031|U|   This medication does not protect against sexually transmitted||
0656|032|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
0656|033|U|an effective barrier method (latex or polyurethane condom/dental||
0656|034|U|dams) during sexual activity will help to decrease your risk of||
0656|035|U|infection.||
0656|036|B|||
0656|037|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0656|038|H|your pharmacist before you start using this product and each time||
0656|039|H|you get a refill. The leaflet contains very important information||
0656|040|H|on when to take your pills and what to do if you miss a dose. If||
0656|041|H|you have any questions, ask your doctor or pharmacist.||
0656|042|H|   Take this medication by mouth as directed by your doctor, with||
0656|043|H|or without food, usually once daily. Pick a time of day that is||
0656|044|H|easy for you to remember, and take your pill at the same time||
0656|045|H|each day, 24 hours apart. Taking this medication after your||
0656|046|H|evening meal or at bedtime may help decrease stomach upset and||
0656|047|H|nausea.||
0656|048|H|   Follow the package instructions to find the first tablet,||
0656|049|H|start with the first tablet in the pack, and take them in the||
0656|050|H|correct order. Do not skip any doses. Pregnancy is more likely if||
0656|051|H|you miss pills, start a new pack late, or take your pill at a||
0656|052|H|different time of the day than usual.||
0656|053|H|   Vomiting or diarrhea can prevent your birth control pills from||
0656|054|H|working well. If you have vomiting or diarrhea, you may need to||
0656|055|H|use a backup birth control method (such as condoms, spermicide).||
0656|056|H|Follow the directions in the Patient Information Leaflet and||
0656|057|H|check with your doctor or pharmacist for more details.||
0656|058|H|   Your pill pack contains 24 pills with active medication (with||
0656|059|H|hormones). It also contains 4 reminder pills (without hormones)||
0656|060|H|at the end of the pack. Take one active pill (with hormones) once||
0656|061|H|daily for 24 days in a row. After you have taken the last active||
0656|062|H|pill, take a reminder pill (without hormones) once daily for 4||
0656|063|H|days in a row unless otherwise directed by your doctor. You||
0656|064|H|should have your period within 3 days after you take the last||
0656|065|H|active tablet in the cycle during the fourth week of the pack.||
0656|066|H|After you have taken the last inactive tablet in the pack, start||
0656|067|H|a new pack the next day whether or not you have your period. If||
0656|068|H|you do not get your period, consult your doctor.||
0656|069|H|   If this is the first time you are using this medication and||
0656|070|H|you are not switching from another form of hormonal birth control||
0656|071|H|(such as patch, other birth control pills), take the first tablet||
0656|072|H|in the pack on the first Sunday following the beginning of your||
0656|073|H|menstrual period or on the first day of your period. If your||
0656|074|H|period begins on a Sunday, begin taking this medication on that||
0656|075|H|day. For the first cycle of use only, use a backup form of||
0656|076|H|non-hormonal birth control (such as condoms, spermicide) for the||
0656|077|H|first 7 days to prevent pregnancy until the medication has enough||
0656|078|H|time to work. If you start on the first day of your period, you||
0656|079|H|do not need to use backup birth control the first week.||
0656|080|H|   Ask your doctor or pharmacist for information about how to||
0656|081|H|switch from other forms of hormonal birth control (such as the||
0656|082|H|patch, other birth control pills) to this product.||
0656|083|B|||
0656|084|S|SIDE EFFECTS:  Nausea, vomiting, headache, bloating, breast||
0656|085|S|tenderness, swelling of the ankles/feet (fluid retention), or||
0656|086|S|weight change may occur. Vaginal bleeding between periods||
0656|087|S|(spotting) or missed/irregular periods may occur, especially||
0656|088|S|during the first few months of use. If any of these effects last||
0656|089|S|or get worse, notify your doctor promptly. If you miss 2 periods||
0656|090|S|in a row (or 1 period if the pill has not been used properly),||
0656|091|S|contact your doctor for a pregnancy test.||
0656|092|S|   Remember that this medication has been prescribed because your||
0656|093|S|doctor has judged that the benefit to you is greater than the||
0656|094|S|risk of side effects. Many people using this medication do not||
0656|095|S|have serious side effects.||
0656|096|S|   This medication may raise your blood pressure. Check your||
0656|097|S|blood pressure regularly and tell your doctor if the results are||
0656|098|S|high.||
0656|099|S|   Tell your doctor right away if you have any serious side||
0656|100|S|effects, including: unusual changes in vaginal bleeding (such as||
0656|101|S|continuous spotting, sudden heavy bleeding, missed periods),||
0656|102|S|symptoms of a high potassium blood level (such as muscle||
0656|103|S|weakness, slow/irregular heartbeat).||
0656|104|S|   This medication may rarely cause serious (sometimes fatal)||
0656|105|S|problems from blood clots (such as heart attack, stroke, blood||
0656|106|S|clots in the lungs or legs). Get medical help right away if you||
0656|107|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
0656|108|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
0656|109|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
0656|110|S|trouble speaking, weakness on one side of the body, sudden vision||
0656|111|S|changes.||
0656|112|S|   Get medical help right away if you have any very serious side||
0656|113|S|effects, including: lumps in the breast, severe stomach/abdominal||
0656|114|S|pain, dark urine, yellowing eyes/skin, mental/mood changes (such||
0656|115|S|as new/worsening depression, suicidal thoughts).||
0656|116|S|   A very serious allergic reaction to this drug is rare.||
0656|117|S|However, get medical help right away if you notice any symptoms||
0656|118|S|of a serious allergic reaction, including: rash, itching/swelling||
0656|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0656|120|S|breathing.||
0656|121|S|   This is not a complete list of possible side effects. If you||
0656|122|S|notice other effects not listed above, contact your doctor or||
0656|123|S|pharmacist.||
0656|124|S|   In the US -||
0656|125|S|   Call your doctor for medical advice about side effects. You||
0656|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0656|127|S|www.fda.gov/medwatch.||
0656|128|S|   In Canada - Call your doctor for medical advice about side||
0656|129|S|effects. You may report side effects to Health Canada at||
0656|130|S|1-866-234-2345.||
0656|131|B|||
0656|132|P|PRECAUTIONS:  See also Warning section.||
0656|133|P|   Before using this medication, tell your doctor or pharmacist||
0656|134|P|if you are allergic to ethinyl estradiol or drospirenone; or to||
0656|135|P|other estrogens or progestins; or if you have any other||
0656|136|P|allergies. This product may contain inactive ingredients, which||
0656|137|P|can cause allergic reactions or other problems. Talk to your||
0656|138|P|pharmacist for more details.||
0656|139|P|   Before using this product, tell your doctor or pharmacist your||
0656|140|P|medical history, especially of: adrenal gland problems, stroke,||
0656|141|P|blood clots (such as in the legs, eyes, lungs), high blood||
0656|142|P|pressure, abnormal breast exam, cancer (especially endometrial or||
0656|143|P|breast cancer), blood clotting disorders (such as protein C or||
0656|144|P|protein S deficiency), diabetes, severe headaches/migraines,||
0656|145|P|family or personal history of a certain swelling disorder||
0656|146|P|(angioedema), heart problems (such as heart valve disease,||
0656|147|P|irregular heartbeat, previous heart attack), kidney problems,||
0656|148|P|liver disease (including tumors), history of yellowing eyes/skin||
0656|149|P|(jaundice) during pregnancy or while using birth control pills,||
0656|150|P|unexplained vaginal bleeding, high cholesterol or triglyceride||
0656|151|P|(blood fat) levels, depression, swelling (edema), gallbladder||
0656|152|P|problems, obesity.||
0656|153|P|   If you have diabetes, this medication may affect your blood||
0656|154|P|sugar. Check your blood sugar regularly as directed and share the||
0656|155|P|results with your doctor. Tell your doctor right away if you have||
0656|156|P|symptoms of high blood sugar such as increased thirst/urination.||
0656|157|P|Your doctor may need to adjust your diabetes medication, exercise||
0656|158|P|program, or diet.||
0656|159|P|   Tell your doctor if you just had or will be having major||
0656|160|P|surgery, or if you will be confined to a chair or bed for a long||
0656|161|P|time (such as a long plane flight). These conditions increase||
0656|162|P|your risk of getting blood clots, especially if you are taking||
0656|163|P|hormonal birth control products. You may need to stop this||
0656|164|P|medication for a time or take special precautions.||
0656|165|P|   Before having surgery, tell your doctor or dentist about all||
0656|166|P|the products you use (including prescription drugs,||
0656|167|P|nonprescription drugs, and herbal products).||
0656|168|P|   This product may increase your potassium levels. Before using||
0656|169|P|potassium supplements or salt substitutes that contain potassium,||
0656|170|P|consult your doctor or pharmacist.||
0656|171|P|   This medication may cause blotchy, dark areas on your face and||
0656|172|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0656|173|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0656|174|P|wear protective clothing when outdoors.||
0656|175|P|   If you are nearsighted or wear contact lenses, you may develop||
0656|176|P|vision problems or trouble wearing your contact lenses. Contact||
0656|177|P|your eye doctor if these problems occur.||
0656|178|P|   It may take longer for you to become pregnant after you stop||
0656|179|P|taking birth control pills. Consult your doctor.||
0656|180|P|   This medication should not be used during pregnancy. If you||
0656|181|P|become pregnant or think you may be pregnant, tell your doctor||
0656|182|P|right away. If you have just given birth or had a pregnancy||
0656|183|P|loss/abortion after the first 3 months, talk with your doctor||
0656|184|P|about reliable forms of birth control, and find out when it is||
0656|185|P|safe to start using birth control that contains a form of||
0656|186|P|estrogen, such as this medication.||
0656|187|P|   This medication passes into breast milk and may harm a nursing||
0656|188|P|infant. Consult your doctor before breastfeeding.||
0656|189|B|||
0656|190|I|DRUG INTERACTIONS:  See also Precautions section.||
0656|191|I|   Drug interactions may change how your medications work or||
0656|192|I|increase your risk for serious side effects. This document does||
0656|193|I|not contain all possible drug interactions. Keep a list of all||
0656|194|I|the products you use (including prescription/nonprescription||
0656|195|I|drugs and herbal products) and share it with your doctor and||
0656|196|I|pharmacist. Do not start, stop, or change the dosage of any||
0656|197|I|medicines without your doctor's approval.||
0656|198|I|   Some products that may interact with this drug include:||
0656|199|I|aromatase inhibitors (such as anastrozole, exemestane),||
0656|200|I|atazanavir/cobicistat, fezolinetant, ospemifene, tamoxifen,||
0656|201|I|tizanidine, tranexamic acid.||
0656|202|I|   Drospirenone may raise your potassium blood level. Tell your||
0656|203|I|doctor if you are regularly taking other drugs/products that can||
0656|204|I|also raise your potassium level (including aliskiren, ACE||
0656|205|I|inhibitors such as enalapril/lisinopril, angiotensin receptor||
0656|206|I|blockers such as losartan/valsartan, heparin, NSAIDs such as||
0656|207|I|ibuprofen/naproxen, potassium-sparing "water pills"/diuretics||
0656|208|I|such as eplerenone/spironolactone/triamterene).||
0656|209|I|   Some drugs may cause hormonal birth control to work less well||
0656|210|I|by decreasing the amount of birth control hormones in your body.||
0656|211|I|This effect can result in pregnancy. Examples of these drugs||
0656|212|I|include griseofulvin, modafinil, rifamycins (such as rifampin),||
0656|213|I|ritonavir, St. John's wort, drugs used to treat seizures (such as||
0656|214|I|barbiturates, carbamazepine, felbamate, phenytoin, primidone,||
0656|215|I|topiramate), HIV drugs (such as nelfinavir, nevirapine), among||
0656|216|I|others. Ask your doctor or pharmacist for more details.||
0656|217|I|   Tell your doctor when you start any new drug, and discuss if||
0656|218|I|you should use reliable backup birth control. Also tell your||
0656|219|I|doctor if you have any new spotting or breakthrough bleeding,||
0656|220|I|because these may be signs that your birth control is not working||
0656|221|I|well.||
0656|222|I|   This medication may interfere with certain lab tests, possibly||
0656|223|I|causing false test results. Make sure lab personnel and all your||
0656|224|I|doctors know you use this drug.||
0656|225|B|||
0656|226|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0656|227|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0656|228|O|poison control center right away. US residents can call||
0656|229|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0656|230|O|Symptoms of overdose may include: severe nausea and vomiting,||
0656|231|O|sudden/unusual vaginal bleeding.||
0656|232|B|||
0656|233|N|NOTES:  Do not share this medication with others.||
0656|234|N|   Regular complete physical exams which include lab and/or||
0656|235|N|medical tests (such as potassium blood level, blood pressure,||
0656|236|N|breast exam, pelvic exam, Pap smear) should be done while you are||
0656|237|N|taking this medication. Follow your doctor's instructions for||
0656|238|N|examining your breasts, and report any lumps right away. Keep all||
0656|239|N|medical and lab appointments. Consult your doctor for more||
0656|240|N|details.||
0656|241|B|||
0656|242|D|MISSED DOSE:  Refer to the product package information for advice||
0656|243|D|on missed doses. You may need to use backup birth control (such||
0656|244|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
0656|245|D|pharmacist if you have any questions.||
0656|246|D|   If you often forget to take your pills as directed, contact||
0656|247|D|your doctor to discuss switching to another form of birth||
0656|248|D|control.||
0656|249|B|||
0656|250|R|STORAGE:  Store at room temperature away from light and moisture.||
0656|251|R|Do not store in the bathroom. Keep all medications away from||
0656|252|R|children and pets.||
0656|253|R|   Do not flush medications down the toilet or pour them into a||
0656|254|R|drain unless instructed to do so. Properly discard this product||
0656|255|R|when it is expired or no longer needed. Consult your pharmacist||
0656|256|R|or local waste disposal company.||
0656|257|B|||
0656|258|A|Information last revised October 2025.||
0656|259|A|Copyright(c) 2025 First Databank, Inc.||
0656|260|B|||
0657|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0657|002|Z|does NOT have all possible information about this product. This||
0657|003|Z|information does not assure that this product is safe, effective,||
0657|004|Z|or appropriate for you. This information is not individual||
0657|005|Z|medical advice and does not substitute for the advice of your||
0657|006|Z|health care professional. Always ask your health care||
0657|007|Z|professional for complete information about this product and your||
0657|008|Z|specific health needs.||
0657|009|B|||
0657|010|T|INSULIN HUMAN ISOPHANE SUSPENSION - INJECTION||
0657|011|F|(IN-sue-lin HYOO-muhn EYE-sew-fane)||
0657|012|B|||
0657|013|C|COMMON BRAND NAME(S): Humulin N, Novolin N||
0657|014|B|||
0657|015|U|USES:  Insulin isophane is used with a proper diet and exercise||
0657|016|U|program to control high blood sugar in people with diabetes.||
0657|017|U|Controlling high blood sugar helps prevent kidney damage,||
0657|018|U|blindness, nerve problems, loss of limbs, and sexual function||
0657|019|U|problems. Proper control of diabetes may also lessen your risk of||
0657|020|U|a heart attack or stroke.||
0657|021|U|   This man-made insulin product is the same as human insulin. It||
0657|022|U|replaces the insulin that your body would normally make. It is an||
0657|023|U|intermediate-acting insulin (isophane). It starts to work more||
0657|024|U|slowly but lasts longer than regular insulin. Insulin isophane||
0657|025|U|works by helping blood sugar (glucose) get into cells so your||
0657|026|U|body can use it for energy. Insulin isophane is often used in||
0657|027|U|combination with a shorter-acting insulin. It may also be used||
0657|028|U|alone or with other oral diabetes drugs (such as metformin).||
0657|029|B|||
0657|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0657|031|H|from your pharmacist before you start using this medication and||
0657|032|H|each time you get a refill. Ask your health care professional how||
0657|033|H|to prepare and use this medication. If you have any questions,||
0657|034|H|ask your doctor or pharmacist.||
0657|035|H|   Inject this medication under the skin as directed by your||
0657|036|H|doctor, usually once or twice a day. The injection is given in||
0657|037|H|the stomach area, the thigh, the buttocks, or the back of the||
0657|038|H|upper arm. Do not inject into a vein or muscle because very low||
0657|039|H|blood sugar (hypoglycemia) may occur.||
0657|040|H|   The dosage is based on your medical condition and response to||
0657|041|H|treatment. Measure each dose very carefully because even small||
0657|042|H|changes in the amount of insulin may have a large effect on your||
0657|043|H|blood sugar.||
0657|044|H|   Before using, gently roll the vial or cartridge, turning it||
0657|045|H|upside down and right side up 10 times to mix the medication. Do||
0657|046|H|not shake the container. Check this product for particles or||
0657|047|H|discoloration. If either is present, do not use the insulin.||
0657|048|H|Insulin isophane should look evenly cloudy/milky after mixing. Do||
0657|049|H|not use if you see clumps of white material, a "frosty"||
0657|050|H|appearance, or particles stuck to the sides of the vial or||
0657|051|H|cartridge.||
0657|052|H|   Before injecting each dose, clean the skin you are going to||
0657|053|H|inject into (the injection site) with rubbing alcohol. Change the||
0657|054|H|injection site each time to lessen injury under the skin (for||
0657|055|H|example, pits/lumps or thickened skin). Do not inject into skin||
0657|056|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
0657|057|H|not rub the injection site after a shot. Do not inject cold||
0657|058|H|insulin because this can be painful. The insulin container you||
0657|059|H|are currently using can be kept at room temperature. Learn how to||
0657|060|H|store and discard medical supplies safely.||
0657|061|H|   This product may be mixed only with certain other insulin||
0657|062|H|products such as insulin regular. Always draw the insulin regular||
0657|063|H|into the syringe first, then follow with the longer-acting||
0657|064|H|insulin. Never inject a mixture of different insulins into a||
0657|065|H|vein. Consult your health care professional about which products||
0657|066|H|may be mixed, the proper method for mixing insulin, and the||
0657|067|H|proper way to inject mixtures of insulin. Do not mix insulins if||
0657|068|H|you are using an insulin pump.||
0657|069|H|   Do not change brands or types of insulin without directions on||
0657|070|H|how to do so from your doctor.||
0657|071|H|   Do not share your pen device with another person, even if the||
0657|072|H|needle is changed. You may give other people a serious infection,||
0657|073|H|or get a serious infection from them.||
0657|074|H|   Use this medication regularly to get the most benefit from it.||
0657|075|H|To help you remember, use it at the same time(s) each day.||
0657|076|H|   Tell your doctor if your condition does not get better or if||
0657|077|H|it gets worse (your blood sugar is too high or too low).||
0657|078|B|||
0657|079|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
0657|080|S|irritation) or weight gain may occur. If any of these effects||
0657|081|S|last or get worse, tell your doctor or pharmacist promptly.||
0657|082|S|   Remember that this medication has been prescribed because your||
0657|083|S|doctor has judged that the benefit to you is greater than the||
0657|084|S|risk of side effects. Many people using this medication do not||
0657|085|S|have serious side effects.||
0657|086|S|   Tell your doctor right away if you have any serious side||
0657|087|S|effects, including: signs of low potassium level in the blood||
0657|088|S|(such as muscle cramps, weakness, irregular heartbeat).||
0657|089|S|   This medication can cause low blood sugar (hypoglycemia). This||
0657|090|S|may occur if you do not get enough calories from food or if you||
0657|091|S|do unusually heavy exercise. Symptoms of low blood sugar include||
0657|092|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
0657|093|S|dizziness, or tingling hands/feet. It is a good habit to carry||
0657|094|S|glucose tablets or gel to treat low blood sugar. If you don't||
0657|095|S|have these reliable forms of glucose, rapidly raise your blood||
0657|096|S|sugar by eating a quick source of sugar such as table sugar,||
0657|097|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
0657|098|S|doctor right away about the reaction and the use of this product.||
0657|099|S|To help prevent low blood sugar, eat meals on a regular schedule,||
0657|100|S|and do not skip meals. Check with your doctor or pharmacist to||
0657|101|S|find out what you should do if you miss a meal.||
0657|102|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0657|103|S|thirst/urination. If these symptoms occur, tell your doctor right||
0657|104|S|away. Your doctor may need to adjust your diabetes medication,||
0657|105|S|exercise program, or diet.||
0657|106|S|   A very serious allergic reaction to this drug is rare.||
0657|107|S|However, get medical help right away if you notice any symptoms||
0657|108|S|of a serious allergic reaction, including: rash, itching/swelling||
0657|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0657|110|S|breathing.||
0657|111|S|   This is not a complete list of possible side effects. If you||
0657|112|S|notice other effects not listed above, contact your doctor or||
0657|113|S|pharmacist.||
0657|114|S|   In the US -||
0657|115|S|   Call your doctor for medical advice about side effects. You||
0657|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0657|117|S|www.fda.gov/medwatch.||
0657|118|S|   In Canada - Call your doctor for medical advice about side||
0657|119|S|effects. You may report side effects to Health Canada at||
0657|120|S|1-866-234-2345.||
0657|121|B|||
0657|122|P|PRECAUTIONS:  Before using insulin isophane, tell your doctor or||
0657|123|P|pharmacist if you are allergic to it; or to other insulins; or if||
0657|124|P|you have any other allergies. This product may contain inactive||
0657|125|P|ingredients, which can cause allergic reactions or other||
0657|126|P|problems. Talk to your pharmacist for more details.||
0657|127|P|   Do not use this medication when you have low blood sugar||
0657|128|P|(hypoglycemia).||
0657|129|P|   Before using this medication, tell your doctor or pharmacist||
0657|130|P|your medical history, especially of: adrenal/pituitary gland||
0657|131|P|problems, kidney disease, liver disease, thyroid problems.||
0657|132|P|   You may experience blurred vision, dizziness, or drowsiness||
0657|133|P|due to extremely low or high blood sugar. Do not drive, use||
0657|134|P|machinery, or do anything that needs alertness or clear vision||
0657|135|P|until you can do it safely.||
0657|136|P|   Limit alcohol while using this medication because it can||
0657|137|P|increase your risk of developing low blood sugar.||
0657|138|P|   It may be harder to control your blood sugar when your body is||
0657|139|P|stressed (such as due to fever, infection, injury, or surgery).||
0657|140|P|Consult your doctor because this may require a change in your||
0657|141|P|treatment plan, medications, or blood sugar testing.||
0657|142|P|   Before having surgery, tell your doctor or dentist about all||
0657|143|P|the products you use (including prescription drugs,||
0657|144|P|nonprescription drugs, and herbal products).||
0657|145|P|   Check your blood sugar before and after exercise. You may need||
0657|146|P|a snack before exercising.||
0657|147|P|   If traveling across time zones, ask your doctor about how to||
0657|148|P|adjust your insulin schedule. Take extra insulin and supplies||
0657|149|P|with you.||
0657|150|P|   Older adults may be more sensitive to the side effects of this||
0657|151|P|drug, especially low blood sugar.||
0657|152|P|   Children may be more sensitive to the side effects of this||
0657|153|P|drug, especially low blood sugar.||
0657|154|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
0657|155|P|cause or worsen diabetes. Discuss a plan with your doctor for||
0657|156|P|managing your blood sugar while pregnant. Your doctor may change||
0657|157|P|your diabetes treatment during your pregnancy (such as diet and||
0657|158|P|medications including insulin).||
0657|159|P|   This medication passes into breast milk, but is unlikely to||
0657|160|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0657|161|P|Your insulin needs may change while breastfeeding.||
0657|162|B|||
0657|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0657|164|I|medications work or increase your risk for serious side effects.||
0657|165|I|This document does not contain all possible drug interactions.||
0657|166|I|Keep a list of all the products you use (including||
0657|167|I|prescription/nonprescription drugs and herbal products) and share||
0657|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
0657|169|I|the dosage of any medicines without your doctor's approval.||
0657|170|I|   A product that may interact with this drug is: repaglinide.||
0657|171|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0657|172|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0657|173|I|heartbeat you would usually feel when your blood sugar falls too||
0657|174|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0657|175|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0657|176|I|   Many drugs can affect your blood sugar levels, making it more||
0657|177|I|difficult to control your blood sugar. Before you start, stop, or||
0657|178|I|change any medication, talk with your doctor or pharmacist about||
0657|179|I|how the medication may affect your blood sugar. Check your blood||
0657|180|I|sugar regularly as directed by your doctor. Tell your doctor||
0657|181|I|about the results and of any symptoms of high or low blood sugar.||
0657|182|I|(See also Side Effects section.) Your doctor may need to adjust||
0657|183|I|your diabetes medication, exercise program, or diet.||
0657|184|B|||
0657|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0657|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0657|187|O|poison control center right away. US residents can call||
0657|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0657|189|O|Symptoms of overdose may include: signs of low blood sugar such||
0657|190|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
0657|191|B|||
0657|192|N|NOTES:  Do not share this medication, needles, or syringes with||
0657|193|N|others.||
0657|194|N|   Attend a diabetes education program to learn more about how to||
0657|195|N|manage your diabetes with medications, diet, exercise, and||
0657|196|N|regular medical exams.||
0657|197|N|   Learn the symptoms of high and low blood sugar and how to||
0657|198|N|treat low blood sugar. Check your blood sugar regularly as||
0657|199|N|directed and share the results with your doctor.||
0657|200|N|   Lab and/or medical tests (such as liver/kidney function,||
0657|201|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
0657|202|N|should be done while you are taking this medication. Keep all||
0657|203|N|medical and lab appointments.||
0657|204|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
0657|205|B|||
0657|206|D|MISSED DOSE:  It is very important to follow your insulin regimen||
0657|207|D|exactly. Ask your doctor ahead of time what you should do if you||
0657|208|D|miss a dose of insulin.||
0657|209|B|||
0657|210|R|STORAGE:  Different brands of this medication have different||
0657|211|R|storage needs. Check the product package for instructions on how||
0657|212|R|to store your brand, or ask your pharmacist. Protect insulin from||
0657|213|R|light and heat. Do not store in the bathroom. Do not freeze, and||
0657|214|R|do not use insulin that has been frozen. Throw away all insulin||
0657|215|R|products after the expiration date on the package, or after the||
0657|216|R|specified number of days after it has been opened or kept at room||
0657|217|R|temperature, whichever date is earlier. Keep all medications away||
0657|218|R|from children and pets.||
0657|219|R|   Do not flush medications down the toilet or pour them into a||
0657|220|R|drain unless instructed to do so. Properly discard this product||
0657|221|R|when it is expired or no longer needed. Consult your pharmacist||
0657|222|R|or local waste disposal company.||
0657|223|B|||
0657|224|M|MEDICAL ALERT:  Your condition can cause complications in a||
0657|225|M|medical emergency. For information about enrolling in MedicAlert,||
0657|226|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0657|227|B|||
0657|228|A|Information last revised April 2025.||
0657|229|A|Copyright(c) 2025 First Databank, Inc.||
0657|230|B|||
0659|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0659|002|Z|does NOT have all possible information about this product. This||
0659|003|Z|information does not assure that this product is safe, effective,||
0659|004|Z|or appropriate for you. This information is not individual||
0659|005|Z|medical advice and does not substitute for the advice of your||
0659|006|Z|health care professional. Always ask your health care||
0659|007|Z|professional for complete information about this product and your||
0659|008|Z|specific health needs.||
0659|009|B|||
0659|010|T|CICLOPIROX SHAMPOO - TOPICAL||
0659|011|F|(sye-kloe-PEER-ox)||
0659|012|B|||
0659|013|C|COMMON BRAND NAME(S): Loprox||
0659|014|B|||
0659|015|U|USES:  This medication is used to treat a certain scalp condition||
0659|016|U|(seborrheic dermatitis). Ciclopirox is an antifungal drug that||
0659|017|U|works by stopping the growth of fungus.||
0659|018|B|||
0659|019|H|HOW TO USE:  This medication is for use on the hair and scalp||
0659|020|H|only.||
0659|021|H|   Wet hair and scalp with water. Apply about one teaspoonful (5||
0659|022|H|milliliters) of this product to wet hair and massage it over your||
0659|023|H|entire scalp until it forms a lather. For long hair, two||
0659|024|H|teaspoonfuls (10 milliliters) of the product may be used. Leave||
0659|025|H|the medication on the scalp and hair for 3 minutes. Then rinse||
0659|026|H|the medication off completely.||
0659|027|H|   Avoid getting this medication in the eyes, nose, mouth, or||
0659|028|H|vaginal area. If you do get medication into these areas, rinse||
0659|029|H|with plenty of water.||
0659|030|H|   Use this medication as directed by your doctor, usually 2||
0659|031|H|times a week with at least 3 days between each use.||
0659|032|H|   Use this medication regularly to get the most benefit from it.||
0659|033|H|To help you remember, mark your calendar with a reminder||
0659|034|H|   Continue to use this medication for the full amount of time||
0659|035|H|prescribed, even if symptoms disappear after a few days.||
0659|036|H|   Tell your doctor if your condition gets worse or does not get||
0659|037|H|better after 4 weeks.||
0659|038|B|||
0659|039|S|SIDE EFFECTS:  Burning, redness, or itching at the application||
0659|040|S|site may occur. If any of these effects last or get worse, tell||
0659|041|S|your doctor or pharmacist promptly.||
0659|042|S|   In people with light-colored hair, changes in hair color have||
0659|043|S|rarely occurred.||
0659|044|S|   Remember that this medication has been prescribed because your||
0659|045|S|doctor has judged that the benefit to you is greater than the||
0659|046|S|risk of side effects. Many people using this medication do not||
0659|047|S|have serious side effects.||
0659|048|S|   Tell your doctor right away if you have any serious side||
0659|049|S|effects, including: blistering/swelling/oozing at the application||
0659|050|S|site.||
0659|051|S|   A very serious allergic reaction to this drug is rare.||
0659|052|S|However, get medical help right away if you notice any symptoms||
0659|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0659|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0659|055|S|breathing.||
0659|056|S|   This is not a complete list of possible side effects. If you||
0659|057|S|notice other effects not listed above, contact your doctor or||
0659|058|S|pharmacist.||
0659|059|S|   In the US -||
0659|060|S|   Call your doctor for medical advice about side effects. You||
0659|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0659|062|S|www.fda.gov/medwatch.||
0659|063|S|   In Canada - Call your doctor for medical advice about side||
0659|064|S|effects. You may report side effects to Health Canada at||
0659|065|S|1-866-234-2345.||
0659|066|B|||
0659|067|P|PRECAUTIONS:  Before using ciclopirox, tell your doctor or||
0659|068|P|pharmacist if you are allergic to it; or if you have any other||
0659|069|P|allergies. This product may contain inactive ingredients, which||
0659|070|P|can cause allergic reactions or other problems. Talk to your||
0659|071|P|pharmacist for more details.||
0659|072|P|   Before using this medication, tell your doctor or pharmacist||
0659|073|P|your medical history.||
0659|074|P|   Before having surgery, tell your doctors or dentist about all||
0659|075|P|the products you use (including prescription drugs,||
0659|076|P|nonprescription drugs, and herbal products).||
0659|077|P|   During pregnancy, this medication should be used only when||
0659|078|P|clearly needed. Discuss the risks and benefits with your doctor.||
0659|079|P|   It is unknown if this medication passes into breast milk.||
0659|080|P|Consult your doctor before breastfeeding.||
0659|081|B|||
0659|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0659|083|I|medications work or increase your risk for serious side effects.||
0659|084|I|This document does not contain all possible drug interactions.||
0659|085|I|Keep a list of all the products you use (including||
0659|086|I|prescription/nonprescription drugs and herbal products) and share||
0659|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
0659|088|I|the dosage of any medicines without your doctor's approval.||
0659|089|B|||
0659|090|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0659|091|O|has overdosed and has serious symptoms such as passing out or||
0659|092|O|trouble breathing, call 911. Otherwise, call a poison control||
0659|093|O|center right away. US residents can call 1-800-222-1222. Canada||
0659|094|O|residents can call 1-844-764-7669.||
0659|095|B|||
0659|096|N|NOTES:  Do not share this medication with others.||
0659|097|N|   This medication has been prescribed for your current condition||
0659|098|N|only. Do not use it later for another skin condition unless told||
0659|099|N|to do so by your doctor. A different medication may be necessary||
0659|100|N|in that case.||
0659|101|B|||
0659|102|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0659|103|D|Do not double the dose to catch up. Wait at least 3 days between||
0659|104|D|uses of the drug. If you have any questions, ask your doctor or||
0659|105|D|pharmacist right away for a new dosing schedule.||
0659|106|B|||
0659|107|R|STORAGE:  Store at room temperature. Keep all medications away||
0659|108|R|from children and pets.||
0659|109|R|   Do not flush medications down the toilet or pour them into a||
0659|110|R|drain unless instructed to do so. Properly discard this product||
0659|111|R|when it is expired or no longer needed. Consult your pharmacist||
0659|112|R|or local waste disposal company.||
0659|113|B|||
0659|114|A|Information last revised November 2024.||
0659|115|A|Copyright(c) 2025 First Databank, Inc.||
0659|116|B|||
0660|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0660|002|Z|does NOT have all possible information about this product. This||
0660|003|Z|information does not assure that this product is safe, effective,||
0660|004|Z|or appropriate for you. This information is not individual||
0660|005|Z|medical advice and does not substitute for the advice of your||
0660|006|Z|health care professional. Always ask your health care||
0660|007|Z|professional for complete information about this product and your||
0660|008|Z|specific health needs.||
0660|009|B|||
0660|010|T|CICLOPIROX SUSPENSION - TOPICAL||
0660|011|F|(sye-kloe-PEER-ox)||
0660|012|B|||
0660|013|C|COMMON BRAND NAME(S): Loprox||
0660|014|B|||
0660|015|U|USES:  This medication is used to treat fungal skin infections||
0660|016|U|such as athlete's foot, jock itch, and ringworm. This medication||
0660|017|U|is also used to treat a skin condition known as pityriasis (tinea||
0660|018|U|versicolor), a fungal infection that causes a lightening or||
0660|019|U|darkening of the skin of the neck, chest, arms, or legs.||
0660|020|U|Ciclopirox is an antifungal medication that works by stopping the||
0660|021|U|growth of fungus.||
0660|022|B|||
0660|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0660|024|H|thoroughly dry the area to be treated. Shake the bottle well||
0660|025|H|before each use. Apply a thin layer of the medication on and||
0660|026|H|around the affected area and gently rub into the skin as directed||
0660|027|H|by your doctor, usually twice daily. Wash your hands after using||
0660|028|H|unless the area being treated includes the hands. Do not wrap,||
0660|029|H|cover, or bandage the area unless directed to do so by your||
0660|030|H|doctor.||
0660|031|H|   Do not apply the medication in the eyes, nose, or mouth, or||
0660|032|H|inside the vagina. If you do get the medication in those areas,||
0660|033|H|rinse with plenty of water.||
0660|034|H|   Use this medication regularly in order to get the most benefit||
0660|035|H|from it. To help you remember, use it at the same times each day.||
0660|036|H|   Continue to use this medication for the full time prescribed,||
0660|037|H|even if symptoms disappear after a few days. Stopping the||
0660|038|H|medication too early may result in a return of the infection.||
0660|039|H|   Your condition should start to get better within the first||
0660|040|H|week of treatment. Tell your doctor if your condition gets worse||
0660|041|H|or if it does not get better after 2 weeks for pityriasis and||
0660|042|H|after 4 weeks for other fungal skin infections.||
0660|043|B|||
0660|044|S|SIDE EFFECTS:  Burning, redness, or itching at the application||
0660|045|S|site may occur. If any of these effects last or get worse, tell||
0660|046|S|your doctor or pharmacist promptly.||
0660|047|S|   Remember that this medication has been prescribed because your||
0660|048|S|doctor has judged that the benefit to you is greater than the||
0660|049|S|risk of side effects. Many people using this medication do not||
0660|050|S|have serious side effects.||
0660|051|S|   Tell your doctor right away if you have any serious side||
0660|052|S|effects, including: blistering/swelling/oozing at the application||
0660|053|S|site.||
0660|054|S|   A very serious allergic reaction to this drug is rare.||
0660|055|S|However, get medical help right away if you notice any symptoms||
0660|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0660|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0660|058|S|breathing.||
0660|059|S|   This is not a complete list of possible side effects. If you||
0660|060|S|notice other effects not listed above, contact your doctor or||
0660|061|S|pharmacist.||
0660|062|S|   In the US -||
0660|063|S|   Call your doctor for medical advice about side effects. You||
0660|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0660|065|S|www.fda.gov/medwatch.||
0660|066|S|   In Canada - Call your doctor for medical advice about side||
0660|067|S|effects. You may report side effects to Health Canada at||
0660|068|S|1-866-234-2345.||
0660|069|B|||
0660|070|P|PRECAUTIONS:  Before using ciclopirox, tell your doctor or||
0660|071|P|pharmacist if you are allergic to it; or if you have any other||
0660|072|P|allergies. This product may contain inactive ingredients, which||
0660|073|P|can cause allergic reactions or other problems. Talk to your||
0660|074|P|pharmacist for more details.||
0660|075|P|   Before using this medication, tell your doctor or pharmacist||
0660|076|P|your medical history.||
0660|077|P|   Before having surgery, tell your doctors or dentist about all||
0660|078|P|the products you use (including prescription drugs,||
0660|079|P|nonprescription drugs, and herbal products).||
0660|080|P|   During pregnancy, this medication should be used only when||
0660|081|P|clearly needed. Discuss the risks and benefits with your doctor.||
0660|082|P|   It is unknown if this medication passes into breast milk.||
0660|083|P|Consult your doctor before breastfeeding.||
0660|084|B|||
0660|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0660|086|I|medications work or increase your risk for serious side effects.||
0660|087|I|This document does not contain all possible drug interactions.||
0660|088|I|Keep a list of all the products you use (including||
0660|089|I|prescription/nonprescription drugs and herbal products) and share||
0660|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
0660|091|I|the dosage of any medicines without your doctor's approval.||
0660|092|B|||
0660|093|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0660|094|O|has overdosed and has serious symptoms such as passing out or||
0660|095|O|trouble breathing, call 911. Otherwise, call a poison control||
0660|096|O|center right away. US residents can call 1-800-222-1222. Canada||
0660|097|O|residents can call 1-844-764-7669.||
0660|098|B|||
0660|099|N|NOTES:  Do not share this medication with others.||
0660|100|N|   This medication has been prescribed for your current condition||
0660|101|N|only. Do not use it later for another skin infection unless told||
0660|102|N|to do so by your doctor. A different medication may be necessary||
0660|103|N|in that case.||
0660|104|N|   If you are treating athlete's foot, make sure to wear||
0660|105|N|well-fitting, ventilated shoes. Also, change socks at least once||
0660|106|N|daily.||
0660|107|B|||
0660|108|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0660|109|D|If it is near the time of the next dose, skip the missed dose.||
0660|110|D|Use your next dose at the regular time. Do not double the dose to||
0660|111|D|catch up.||
0660|112|B|||
0660|113|R|STORAGE:  Store at room temperature. Keep all medications away||
0660|114|R|from children and pets.||
0660|115|R|   Do not flush medications down the toilet or pour them into a||
0660|116|R|drain unless instructed to do so. Properly discard this product||
0660|117|R|when it is expired or no longer needed. Consult your pharmacist||
0660|118|R|or local waste disposal company.||
0660|119|B|||
0660|120|A|Information last revised November 2024.||
0660|121|A|Copyright(c) 2025 First Databank, Inc.||
0660|122|B|||
0661|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0661|002|Z|does NOT have all possible information about this product. This||
0661|003|Z|information does not assure that this product is safe, effective,||
0661|004|Z|or appropriate for you. This information is not individual||
0661|005|Z|medical advice and does not substitute for the advice of your||
0661|006|Z|health care professional. Always ask your health care||
0661|007|Z|professional for complete information about this product and your||
0661|008|Z|specific health needs.||
0661|009|B|||
0661|010|T|CILAZAPRIL/HYDROCHLOROTHIAZIDE - ORAL||
0661|011|F|(sye-LAY-za-pril/HYE-droe-KLOR-oh-THYE-a-zide)||
0661|012|B|||
0661|013|W|WARNING:  This medication can cause serious (possibly fatal) harm||
0661|014|W|to an unborn baby if used during pregnancy. It is important to||
0661|015|W|prevent pregnancy while taking this medication. Consult your||
0661|016|W|doctor for more details and to discuss the use of reliable forms||
0661|017|W|of birth control while taking this medication. If you are||
0661|018|W|planning pregnancy, become pregnant, or think you may be||
0661|019|W|pregnant, inform your doctor right away.||
0661|020|B|||
0661|021|U|USES:  This medication is used to treat high blood pressure||
0661|022|U|(hypertension). Lowering high blood pressure helps prevent||
0661|023|U|strokes, heart attacks, and kidney problems.||
0661|024|U|   This product contains two medications, cilazapril and||
0661|025|U|hydrochlorothiazide. Cilazapril is called an ACE inhibitor and||
0661|026|U|works by relaxing blood vessels so that blood can flow through||
0661|027|U|the body more easily. Hydrochlorothiazide (or "The thiazide||
0661|028|U|diuretic") increases the amount of urine you make, removing extra||
0661|029|U|water and salt from your body. Getting rid of extra water and||
0661|030|U|salt probably also helps to relax the blood vessels so that blood||
0661|031|U|can flow more easily. These medications are used together when||
0661|032|U|one drug is not controlling your blood pressure.||
0661|033|U|   This medication is not recommended as the first medication for||
0661|034|U|treating high blood pressure. Your doctor will usually start you||
0661|035|U|on the individual medications first, and then switch you over to||
0661|036|U|this combination product if this is the best dose combination for||
0661|037|U|you.||
0661|038|B|||
0661|039|H|HOW TO USE:  Take this medication by mouth with or without food||
0661|040|H|as directed by your doctor, usually once or twice daily. If you||
0661|041|H|take this drug too close to bedtime, you may need to wake up to||
0661|042|H|urinate. It is best to take this medication at least 4 hours||
0661|043|H|before your bedtime. Consult your doctor or pharmacist if you||
0661|044|H|have questions about your dosing schedule.||
0661|045|H|   If you are also taking cholestyramine or colestipol, take||
0661|046|H|cilazapril/hydrochlorothiazide at least 4 hours before or at||
0661|047|H|least 4 to 6 hours after either of those drugs.||
0661|048|H|   The dosage is based on your medical condition and response to||
0661|049|H|treatment||
0661|050|H|   Use this medication regularly in order to get the most benefit||
0661|051|H|from it. To help you remember, take it at the same time(s) each||
0661|052|H|day. Keep taking this medication even if you feel well. Most||
0661|053|H|people with high blood pressure do not feel sick. It may take up||
0661|054|H|to several weeks before the full benefit of this drug takes||
0661|055|H|effect.||
0661|056|H|   Tell your doctor if your condition does not get better or if||
0661|057|H|it gets worse (your blood pressure readings remain high or||
0661|058|H|increase).||
0661|059|B|||
0661|060|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
0661|061|S|body adjusts to the medication. Nausea or dry cough may also||
0661|062|S|occur. If any of these effects last or get worse, tell your||
0661|063|S|doctor or pharmacist promptly.||
0661|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
0661|065|S|slowly when rising from a sitting or lying position.||
0661|066|S|   Remember that this medication has been prescribed because your||
0661|067|S|doctor has judged that the benefit to you is greater than the||
0661|068|S|risk of side effects. Many people using this medication do not||
0661|069|S|have serious side effects.||
0661|070|S|   This product may cause dehydration and electrolyte imbalance.||
0661|071|S|Tell your doctor right away if you have any symptoms of||
0661|072|S|dehydration or electrolyte imbalance, including unusual dry||
0661|073|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0661|074|S|heartbeat, or confusion.||
0661|075|S|   Tell your doctor right away if you have any serious side||
0661|076|S|effects, including: swelling of the hands/feet, fainting,||
0661|077|S|mental/mood changes, numbness/tingling of the hands/feet,||
0661|078|S|muscle/joint aches, decreased sexual ability/interest, easy||
0661|079|S|bruising/bleeding, signs of kidney problems (such as change in||
0661|080|S|the amount of urine), decrease in vision, eye pain.||
0661|081|S|   This drug may rarely cause serious (possibly fatal) liver||
0661|082|S|problems. Get medical help right away if you have any symptoms of||
0661|083|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0661|084|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0661|085|S|urine.||
0661|086|S|   A very serious allergic reaction to this drug is rare.||
0661|087|S|However, get medical help right away if you notice any symptoms||
0661|088|S|of a serious allergic reaction, including: rash, itching/swelling||
0661|089|S|(especially of the face/tongue/throat/neck), severe dizziness,||
0661|090|S|trouble breathing.||
0661|091|S|   This is not a complete list of possible side effects. If you||
0661|092|S|notice other effects not listed above, contact your doctor or||
0661|093|S|pharmacist.||
0661|094|S|   In the US -||
0661|095|S|   Call your doctor for medical advice about side effects. You||
0661|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0661|097|S|www.fda.gov/medwatch.||
0661|098|S|   In Canada - Call your doctor for medical advice about side||
0661|099|S|effects. You may report side effects to Health Canada at||
0661|100|S|1-866-234-2345.||
0661|101|B|||
0661|102|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0661|103|P|pharmacist if you are allergic to either cilazapril or||
0661|104|P|hydrochlorothiazide; or to other ACE inhibitors (such as||
0661|105|P|captopril, lisinopril); or to other thiazides (such as||
0661|106|P|chlorothiazide); or if you have any other allergies. This product||
0661|107|P|may contain inactive ingredients, which can cause allergic||
0661|108|P|reactions or other problems. Talk to your pharmacist for more||
0661|109|P|details.||
0661|110|P|   Before using this medication, tell your doctor or pharmacist||
0661|111|P|your medical history, especially of: a history of an allergic||
0661|112|P|reaction that included swelling of the face/lips/tongue/throat||
0661|113|P|(angioedema), kidney problems (such as renal artery stenosis,||
0661|114|P|inability to make urine), blood exchange procedures (such as||
0661|115|P|apheresis, dialysis), liver disease, gout, untreated salt||
0661|116|P|imbalance (such as high calcium, high/low potassium, low||
0661|117|P|magnesium), dehydration, lupus, skin cancer.||
0661|118|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0661|119|P|can make you more dizzy. Do not drive, use machinery, or do||
0661|120|P|anything that needs alertness until you can do it safely. Limit||
0661|121|P|alcoholic beverages. Talk to your doctor if you are using||
0661|122|P|marijuana (cannabis).||
0661|123|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0661|124|P|and cause you to feel lightheaded. Tell your doctor if you have||
0661|125|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0661|126|P|of fluids unless your doctor tells you not to.||
0661|127|P|   Before having surgery, tell your doctor or dentist about all||
0661|128|P|the products you use (including prescription drugs,||
0661|129|P|nonprescription drugs, and herbal products).||
0661|130|P|   This medication may make you more sensitive to the sun. It may||
0661|131|P|also increase your risk for skin cancer, especially if you take||
0661|132|P|it for a long time. Limit your time in the sun. Avoid tanning||
0661|133|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0661|134|P|when outdoors. Tell your doctor right away if you get sunburned,||
0661|135|P|have skin blisters/redness, or notice new or changed moles/skin||
0661|136|P|lesions.||
0661|137|P|   This product may affect your potassium levels. Before using||
0661|138|P|potassium supplements or salt substitutes containing potassium,||
0661|139|P|consult your doctor or pharmacist.||
0661|140|P|   If you have diabetes, this product may increase your blood||
0661|141|P|sugar. Check your blood sugar regularly as directed and share the||
0661|142|P|results with your doctor. Tell your doctor right away if you have||
0661|143|P|symptoms of high blood sugar, such as increased thirst/urination.||
0661|144|P|Your doctor may need to adjust your diabetes medication, exercise||
0661|145|P|program, or diet.||
0661|146|P|   Older adults may be more sensitive to the side effects of this||
0661|147|P|drug, especially dizziness and change in the amount of urine||
0661|148|P|(kidney problems).||
0661|149|P|   Tell your doctor if you are pregnant or plan to become||
0661|150|P|pregnant. You should not become pregnant while using this||
0661|151|P|medication. Cilazapril may harm an unborn baby. If you become||
0661|152|P|pregnant, talk to your doctor right away about the risks and||
0661|153|P|benefits of this medication. (See also Warning section.)||
0661|154|P|   This medication passes into breast milk. Consult your doctor||
0661|155|P|before breastfeeding.||
0661|156|B|||
0661|157|I|DRUG INTERACTIONS:  See also Precautions section.||
0661|158|I|   Drug interactions may change how your medications work or||
0661|159|I|increase your risk for serious side effects. This document does||
0661|160|I|not contain all possible drug interactions. Keep a list of all||
0661|161|I|the products you use (including prescription/nonprescription||
0661|162|I|drugs and herbal products) and share it with your doctor and||
0661|163|I|pharmacist. Do not start, stop, or change the dosage of any||
0661|164|I|medicines without your doctor's approval.||
0661|165|I|   Some products that may interact with this drug are: aliskiren,||
0661|166|I|alpha blockers (such as prazosin, terazosin), certain||
0661|167|I|nonsteroidal anti-inflammatory drugs-NSAIDs (such as celecoxib,||
0661|168|I|ibuprofen, indomethacin), dofetilide, drugs that may increase the||
0661|169|I|level of potassium in the blood (such as ARBs including||
0661|170|I|losartan/valsartan, birth control pills containing drospirenone),||
0661|171|I|certain drugs that weaken the immune system/increase the risk of||
0661|172|I|infection (such as everolimus, sirolimus), lithium, probenecid,||
0661|173|I|gold injections, sacubitril.||
0661|174|I|   A very serious reaction may occur if you are getting||
0661|175|I|injections for bee/wasp sting allergy (desensitization) and are||
0661|176|I|also taking cilazapril with hydrochlorothiazide. Make sure all||
0661|177|I|your doctors know which medicines you are using.||
0661|178|I|   Some products have ingredients that could raise your blood||
0661|179|I|pressure. Tell your pharmacist what products you are using, and||
0661|180|I|ask how to use them safely (especially cough-and-cold products,||
0661|181|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0661|182|I|   This medication may interfere with certain lab tests (such as||
0661|183|I|parathyroid, protein-bound iodide, tyramine and phentolamine||
0661|184|I|tests), possibly causing false test results. Make sure lab||
0661|185|I|personnel and all your doctors know you use this drug.||
0661|186|B|||
0661|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0661|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0661|189|O|poison control center right away. US residents can call||
0661|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0661|191|O|Symptoms of overdose may include: severe dizziness.||
0661|192|B|||
0661|193|N|NOTES:  Do not share this medication with others. Lifestyle||
0661|194|N|changes such as stress reduction programs, exercise, and dietary||
0661|195|N|changes may increase the effectiveness of this medicine. Talk to||
0661|196|N|your doctor or pharmacist about lifestyle changes that might||
0661|197|N|benefit you.||
0661|198|N|   Lab and/or medical tests (such as complete blood count, blood||
0661|199|N|sodium and potassium levels, kidney function, liver function,||
0661|200|N|skin exams, cholesterol levels) should be done while you are||
0661|201|N|taking this medication. Keep all medical and lab appointments.||
0661|202|N|Consult your doctor for more details.||
0661|203|N|   Check your blood pressure regularly while taking this||
0661|204|N|medication, especially when you first start this drug or when||
0661|205|N|your dose is changed. Learn how to monitor your own blood||
0661|206|N|pressure at home, and share the results with your doctor.||
0661|207|B|||
0661|208|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0661|209|D|remember. If it is near the time of the next dose, skip the||
0661|210|D|missed dose. Take your next dose at the regular time. Do not||
0661|211|D|double the dose to catch up.||
0661|212|B|||
0661|213|R|STORAGE:  Store at room temperature away from light and moisture.||
0661|214|R|Do not store in the bathroom. Keep all medications away from||
0661|215|R|children and pets.||
0661|216|R|   Do not flush medications down the toilet or pour them into a||
0661|217|R|drain unless instructed to do so. Properly discard this product||
0661|218|R|when it is expired or no longer needed. Consult your pharmacist||
0661|219|R|or local waste disposal company.||
0661|220|B|||
0661|221|A|Information last revised April 2025.||
0661|222|A|Copyright(c) 2025 First Databank, Inc.||
0661|223|B|||
0662|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0662|002|Z|does NOT have all possible information about this product. This||
0662|003|Z|information does not assure that this product is safe, effective,||
0662|004|Z|or appropriate for you. This information is not individual||
0662|005|Z|medical advice and does not substitute for the advice of your||
0662|006|Z|health care professional. Always ask your health care||
0662|007|Z|professional for complete information about this product and your||
0662|008|Z|specific health needs.||
0662|009|B|||
0662|010|T|CICLOPIROX GEL - TOPICAL||
0662|011|F|(cyc-low-PIE-rocks)||
0662|012|B|||
0662|013|C|COMMON BRAND NAME(S): Loprox||
0662|014|B|||
0662|015|U|USES:  This medication is used to treat certain fungal skin||
0662|016|U|infections such as ringworm and athlete's foot between the toes.||
0662|017|U|It is also used to treat a certain scalp condition (seborrheic||
0662|018|U|dermatitis). Ciclopirox is an antifungal medication that works by||
0662|019|U|stopping the growth of fungus.||
0662|020|B|||
0662|021|H|HOW TO USE:  Use this medication on the skin only. Clean and dry||
0662|022|H|the area to be treated. Apply a thin layer of the medication on||
0662|023|H|and around the affected area and gently rub into the skin or||
0662|024|H|scalp as directed by your doctor, usually twice daily. Wash your||
0662|025|H|hands after using unless the area being treated includes the||
0662|026|H|hands. Do not wrap, cover, or bandage the area unless directed to||
0662|027|H|do so by your doctor.||
0662|028|H|   Do not apply the medication in the eyes, nose, or mouth, or||
0662|029|H|inside the vagina. If you do get the medication in those areas,||
0662|030|H|rinse with plenty of water.||
0662|031|H|   Use this medication regularly in order to get the most benefit||
0662|032|H|from it. To help you remember, use it at the same times each day.||
0662|033|H|   Continue to use this medication for the full time prescribed,||
0662|034|H|even if symptoms disappear after a few days. Stopping the||
0662|035|H|medication too early may result in a return of the infection.||
0662|036|H|   Tell your doctor if your condition gets worse or does not get||
0662|037|H|better after 4 weeks.||
0662|038|B|||
0662|039|S|SIDE EFFECTS:  Burning, stinging, redness, or itching at the||
0662|040|S|application site may occur. If any of these effects last or get||
0662|041|S|worse, tell your doctor or pharmacist promptly.||
0662|042|S|   Remember that this medication has been prescribed because your||
0662|043|S|doctor has judged that the benefit to you is greater than the||
0662|044|S|risk of side effects. Many people using this medication do not||
0662|045|S|have serious side effects.||
0662|046|S|   Tell your doctor right away if you have any serious side||
0662|047|S|effects, including: blistering/swelling/oozing at the application||
0662|048|S|site.||
0662|049|S|   A very serious allergic reaction to this drug is rare.||
0662|050|S|However, get medical help right away if you notice any symptoms||
0662|051|S|of a serious allergic reaction, including: rash, itching/swelling||
0662|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0662|053|S|breathing.||
0662|054|S|   This is not a complete list of possible side effects. If you||
0662|055|S|notice other effects not listed above, contact your doctor or||
0662|056|S|pharmacist.||
0662|057|S|   In the US -||
0662|058|S|   Call your doctor for medical advice about side effects. You||
0662|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0662|060|S|www.fda.gov/medwatch.||
0662|061|S|   In Canada - Call your doctor for medical advice about side||
0662|062|S|effects. You may report side effects to Health Canada at||
0662|063|S|1-866-234-2345.||
0662|064|B|||
0662|065|P|PRECAUTIONS:  Before using ciclopirox, tell your doctor or||
0662|066|P|pharmacist if you are allergic to it; or if you have any other||
0662|067|P|allergies. This product may contain inactive ingredients, which||
0662|068|P|can cause allergic reactions or other problems. Talk to your||
0662|069|P|pharmacist for more details.||
0662|070|P|   Before using this medication, tell your doctor or pharmacist||
0662|071|P|your medical history.||
0662|072|P|   Before having surgery, tell your doctors or dentist about all||
0662|073|P|the products you use (including prescription drugs,||
0662|074|P|nonprescription drugs, and herbal products).||
0662|075|P|   During pregnancy, this medication should be used only when||
0662|076|P|clearly needed. Discuss the risks and benefits with your doctor.||
0662|077|P|   It is unknown if this medication passes into breast milk.||
0662|078|P|Consult your doctor before breastfeeding.||
0662|079|B|||
0662|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0662|081|I|medications work or increase your risk for serious side effects.||
0662|082|I|This document does not contain all possible drug interactions.||
0662|083|I|Keep a list of all the products you use (including||
0662|084|I|prescription/nonprescription drugs and herbal products) and share||
0662|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
0662|086|I|the dosage of any medicines without your doctor's approval.||
0662|087|B|||
0662|088|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0662|089|O|has overdosed and has serious symptoms such as passing out or||
0662|090|O|trouble breathing, call 911. Otherwise, call a poison control||
0662|091|O|center right away. US residents can call 1-800-222-1222. Canada||
0662|092|O|residents can call 1-844-764-7669.||
0662|093|B|||
0662|094|N|NOTES:  Do not share this medication with others.||
0662|095|N|   This medication has been prescribed for your current condition||
0662|096|N|only. Do not use it later for another skin infection unless told||
0662|097|N|to do so by your doctor. A different medication may be necessary||
0662|098|N|in that case.||
0662|099|N|   If you are treating athlete's foot, make sure to wear||
0662|100|N|well-fitting, ventilated shoes. Also, change socks at least once||
0662|101|N|daily.||
0662|102|B|||
0662|103|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0662|104|D|If it is near the time of the next dose, skip the missed dose.||
0662|105|D|Use your next dose at the regular time. Do not double the dose to||
0662|106|D|catch up.||
0662|107|B|||
0662|108|R|STORAGE:  Store at room temperature away from heat. Keep all||
0662|109|R|medications away from children and pets.||
0662|110|R|   Do not flush medications down the toilet or pour them into a||
0662|111|R|drain unless instructed to do so. Properly discard this product||
0662|112|R|when it is expired or no longer needed. Consult your pharmacist||
0662|113|R|or local waste disposal company.||
0662|114|B|||
0662|115|A|Information last revised November 2024.||
0662|116|A|Copyright(c) 2025 First Databank, Inc.||
0662|117|B|||
0663|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0663|002|Z|does NOT have all possible information about this product. This||
0663|003|Z|information does not assure that this product is safe, effective,||
0663|004|Z|or appropriate for you. This information is not individual||
0663|005|Z|medical advice and does not substitute for the advice of your||
0663|006|Z|health care professional. Always ask your health care||
0663|007|Z|professional for complete information about this product and your||
0663|008|Z|specific health needs.||
0663|009|B|||
0663|010|T|CARBINOXAMINE - ORAL||
0663|011|F|(kar-bi-NOX-a-meen)||
0663|012|B|||
0663|013|C|COMMON BRAND NAME(S): Histex PD, Palgic||
0663|014|B|||
0663|015|U|USES:  Carbinoxamine is an antihistamine used to relieve symptoms||
0663|016|U|of allergy, hay fever, and the common cold. These symptoms||
0663|017|U|include rash, watery eyes, itchy eyes/nose/throat/skin, cough,||
0663|018|U|runny nose, and sneezing.||
0663|019|U|   This medication works by blocking a certain natural substance||
0663|020|U|(histamine) that your body makes during an allergic reaction. By||
0663|021|U|blocking another natural substance made by your body||
0663|022|U|(acetylcholine), it helps dry up some body fluids to relieve||
0663|023|U|symptoms such as watery eyes and runny nose.||
0663|024|U|   Cough-and-cold products have not been shown to be safe or||
0663|025|U|effective in children younger than 6 years. Do not use this||
0663|026|U|product to treat cold symptoms in children younger than 6 years||
0663|027|U|unless specifically directed by the doctor. Some products (such||
0663|028|U|as long-acting tablets/capsules) are not recommended for use in||
0663|029|U|children younger than 12 years. Ask your doctor or pharmacist for||
0663|030|U|more details about using your product safely.||
0663|031|U|   These products do not cure or shorten the length of the common||
0663|032|U|cold and may cause serious side effects. To decrease the risk for||
0663|033|U|serious side effects, carefully follow all dosage directions. Do||
0663|034|U|not use this product to make a child sleepy. Do not give other||
0663|035|U|cough-and-cold medication that might contain the same or similar||
0663|036|U|ingredients (see also Drug Interactions section). Ask the doctor||
0663|037|U|or pharmacist about other ways to relieve cough and cold symptoms||
0663|038|U|(such as drinking enough fluids, using a humidifier or saline||
0663|039|U|nose drops/spray).||
0663|040|B|||
0663|041|H|HOW TO USE:  Take the tablet, capsule, or liquid form by mouth||
0663|042|H|with or without food as directed by your doctor. This medication||
0663|043|H|may be taken with food or milk if stomach upset occurs.||
0663|044|H|   If you are using sustained-release tablets or capsules,||
0663|045|H|swallow the medication whole. Do not crush, chew, or break the||
0663|046|H|tablets or capsules. Doing so can destroy the long action of the||
0663|047|H|drug and may increase side effects.||
0663|048|H|   If you are using the liquid form of this medication, measure||
0663|049|H|the dose carefully using a special measuring device/cup. Do not||
0663|050|H|use a household spoon because you may not get the correct dose.||
0663|051|H|If your liquid form is a suspension, shake the bottle well before||
0663|052|H|each dose.||
0663|053|H|   The dosage is based on your age, medical condition, and||
0663|054|H|response to treatment. Do not increase your dose or take this||
0663|055|H|medication more often without your doctor's approval. Take this||
0663|056|H|medication regularly in order to get the most benefit from it. To||
0663|057|H|help you remember, take it at the same time(s) each day.||
0663|058|H|   Tell your doctor if your condition lasts or if it gets worse.||
0663|059|B|||
0663|060|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, constipation,||
0663|061|S|stomach upset, blurred vision, decreased coordination, or dry||
0663|062|S|mouth/nose/throat may occur. These effects may decrease as your||
0663|063|S|body adjusts to the medication. If any of these effects last or||
0663|064|S|get worse, contact your doctor or pharmacist promptly.||
0663|065|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0663|066|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0663|067|S|substitute. Carbinoxamine can dry up and thicken mucus in your||
0663|068|S|lungs, making it more difficult to breathe and clear your lungs.||
0663|069|S|To help prevent this effect, drink plenty of fluids unless||
0663|070|S|otherwise directed by your doctor.||
0663|071|S|   To reduce the risk of dizziness and lightheadedness, get up||
0663|072|S|slowly when rising from a sitting or lying position.||
0663|073|S|   Remember that this medication has been prescribed because your||
0663|074|S|doctor has judged that the benefit to you is greater than the||
0663|075|S|risk of side effects. Many people using this medication do not||
0663|076|S|have serious side effects.||
0663|077|S|   Tell your doctor right away if you have any serious side||
0663|078|S|effects, including: mental/mood changes (such as hallucinations,||
0663|079|S|irritability, nervousness, confusion), ringing in the ears,||
0663|080|S|trouble urinating, easy bruising/bleeding, fast/irregular||
0663|081|S|heartbeat, seizure.||
0663|082|S|   A very serious allergic reaction to this drug is rare.||
0663|083|S|However, get medical help right away if you notice any symptoms||
0663|084|S|of a serious allergic reaction, including: rash, itching/swelling||
0663|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0663|086|S|breathing.||
0663|087|S|   This is not a complete list of possible side effects. If you||
0663|088|S|notice other effects not listed above, contact your doctor or||
0663|089|S|pharmacist.||
0663|090|S|   In the US -||
0663|091|S|   Call your doctor for medical advice about side effects. You||
0663|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0663|093|S|www.fda.gov/medwatch.||
0663|094|S|   In Canada - Call your doctor for medical advice about side||
0663|095|S|effects. You may report side effects to Health Canada at||
0663|096|S|1-866-234-2345.||
0663|097|B|||
0663|098|P|PRECAUTIONS:  Before taking carbinoxamine, tell your doctor or||
0663|099|P|pharmacist if you are allergic to it; or if you have any other||
0663|100|P|allergies. This product may contain inactive ingredients, which||
0663|101|P|can cause allergic reactions or other problems. Talk to your||
0663|102|P|pharmacist for more details.||
0663|103|P|   Before using this medication, tell your doctor or pharmacist||
0663|104|P|your medical history, especially of: breathing problems (such as||
0663|105|P|asthma, emphysema), a certain eye problem (glaucoma), heart||
0663|106|P|problems, high blood pressure, liver disease, seizures, stomach||
0663|107|P|problems (such as ulcers, blockage), overactive thyroid||
0663|108|P|(hyperthyroidism), urination problems (such as trouble urinating||
0663|109|P|due to enlarged prostate, urinary retention).||
0663|110|P|   This drug may make you dizzy or drowsy or blur your vision.||
0663|111|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0663|112|P|drowsy. Do not drive, use machinery, or do anything that needs||
0663|113|P|alertness or clear vision until you can do it safely. Limit||
0663|114|P|alcoholic beverages. Talk to your doctor if you are using||
0663|115|P|marijuana (cannabis).||
0663|116|P|   Older adults may be more sensitive to the side effects of this||
0663|117|P|drug, especially drowsiness, dizziness, low blood pressure,||
0663|118|P|confusion, constipation, or trouble urinating. Drowsiness,||
0663|119|P|dizziness, and confusion can increase the risk of falling.||
0663|120|P|   Children may be more sensitive to the side effects of this||
0663|121|P|medication. In young children, this medication may cause||
0663|122|P|agitation/excitement instead of drowsiness.||
0663|123|P|   During pregnancy, this medication should be used only when||
0663|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
0663|125|P|   This drug may pass into breast milk and could have undesirable||
0663|126|P|effects on a nursing infant. Consult your doctor before||
0663|127|P|breastfeeding.||
0663|128|B|||
0663|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0663|130|I|medications work or increase your risk for serious side effects.||
0663|131|I|This document does not contain all possible drug interactions.||
0663|132|I|Keep a list of all the products you use (including||
0663|133|I|prescription/nonprescription drugs and herbal products) and share||
0663|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
0663|135|I|the dosage of any medicines without your doctor's approval.||
0663|136|I|   Some of the products that may interact with this drug include:||
0663|137|I|antihistamines applied to the skin (such as diphenhydramine||
0663|138|I|cream, ointment, spray).||
0663|139|I|   Tell your doctor or pharmacist if you are taking other||
0663|140|I|products that cause drowsiness such as opioid pain or cough||
0663|141|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0663|142|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0663|143|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0663|144|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0663|145|I|diphenhydramine).||
0663|146|I|   Check the labels on all your medicines (such as allergy or||
0663|147|I|cough-and-cold products) because they may contain ingredients||
0663|148|I|that cause drowsiness. Ask your pharmacist about using those||
0663|149|I|products safely.||
0663|150|I|   This medication may interfere with certain lab tests (such as||
0663|151|I|allergy skin test), possibly causing false test results. Make||
0663|152|I|sure lab personnel and all your doctors know you use this drug.||
0663|153|B|||
0663|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0663|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0663|156|O|poison control center right away. US residents can call||
0663|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0663|158|O|Symptoms of overdose may include: large pupils, flushing, fever,||
0663|159|O|hallucinations, weakness, shaking (tremor), muscle twitching,||
0663|160|O|loss of consciousness, seizures. In children, excitement may||
0663|161|O|occur first, and may be followed by loss of coordination,||
0663|162|O|drowsiness, loss of consciousness, seizures.||
0663|163|B|||
0663|164|N|NOTES:  Do not share this medication with others.||
0663|165|B|||
0663|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0663|167|D|remember. If it is near the time of your next dose, skip the||
0663|168|D|missed dose. Take your next dose at the regular time. Do not||
0663|169|D|double the dose to catch up.||
0663|170|B|||
0663|171|R|STORAGE:  Store at room temperature away from moisture and light.||
0663|172|R|Do not store in the bathroom. Do not freeze liquid forms of this||
0663|173|R|medication. Keep all medications away from children and pets.||
0663|174|R|   Do not flush medications down the toilet or pour them into a||
0663|175|R|drain unless instructed to do so. Properly discard this product||
0663|176|R|when it is expired or no longer needed. Consult your pharmacist||
0663|177|R|or local waste disposal company.||
0663|178|B|||
0663|179|A|Information last revised May 2024.||
0663|180|A|Copyright(c) 2025 First Databank, Inc.||
0663|181|B|||
0664|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0664|002|Z|does NOT have all possible information about this product. This||
0664|003|Z|information does not assure that this product is safe, effective,||
0664|004|Z|or appropriate for you. This information is not individual||
0664|005|Z|medical advice and does not substitute for the advice of your||
0664|006|Z|health care professional. Always ask your health care||
0664|007|Z|professional for complete information about this product and your||
0664|008|Z|specific health needs.||
0664|009|B|||
0664|010|T|DOXYLAMINE - ORAL||
0664|011|F|(dox-IL-a-meen)||
0664|012|B|||
0664|013|C|COMMON BRAND NAME(S): Unisom Sleep Aid||
0664|014|B|||
0664|015|U|USES:  Doxylamine is an antihistamine, used to relieve symptoms||
0664|016|U|of allergy, hay fever, and the common cold. This medication works||
0664|017|U|by blocking certain natural substances (histamine, acetylcholine)||
0664|018|U|that your body makes. This effect helps to relieve allergy/cold||
0664|019|U|symptoms such as watery eyes, runny nose, and sneezing.||
0664|020|U|Doxylamine is also used to help you relax and fall asleep.||
0664|021|U|   Cough-and-cold products have not been shown to be safe or||
0664|022|U|effective in children younger than 6 years. Do not use this||
0664|023|U|product to treat cold symptoms in children younger than 6 years||
0664|024|U|unless specifically directed by the doctor. Also, do not give the||
0664|025|U|25 milligram tablets to children younger than 12 years, unless||
0664|026|U|directed by the doctor. Ask your doctor or pharmacist for more||
0664|027|U|details about using your product safely.||
0664|028|U|   These products do not cure or shorten the length of the common||
0664|029|U|cold and may cause serious side effects. To decrease the risk for||
0664|030|U|serious side effects, carefully follow all dosage directions. Do||
0664|031|U|not use this product to make a child sleepy. Do not give other||
0664|032|U|cough-and-cold medication that might contain the same or similar||
0664|033|U|ingredients (see also Drug Interactions section). Ask the doctor||
0664|034|U|or pharmacist about other ways to relieve cough and cold symptoms||
0664|035|U|(such as drinking enough fluids, using a humidifier or saline||
0664|036|U|nose drops/spray).||
0664|037|B|||
0664|038|H|HOW TO USE:  Follow all directions on the product package. If||
0664|039|H|your doctor has prescribed this medication, take it as directed.||
0664|040|H|If you have any questions, ask your doctor or pharmacist.||
0664|041|H|   Take this medication by mouth with or without food. This||
0664|042|H|medication may be taken with food or milk if stomach upset||
0664|043|H|occurs.||
0664|044|H|   If you are using the chewable form of this medication, chew||
0664|045|H|thoroughly and then swallow.||
0664|046|H|   If you are using the liquid form of this medication, measure||
0664|047|H|the dose carefully using a special measuring device/spoon. Do not||
0664|048|H|use a household spoon because you may not get the correct dose.||
0664|049|H|   The dosage is based on your age, medical condition, and||
0664|050|H|response to treatment. Do not increase your dose or take this||
0664|051|H|medication more often than directed.||
0664|052|H|   To help you sleep, take this medication about 30 minutes||
0664|053|H|before bedtime. If you continue to have difficulty sleeping for||
0664|054|H|longer than 2 weeks, contact your doctor.||
0664|055|H|   If your condition lasts or gets worse, or if you think you may||
0664|056|H|have a serious medical problem, get medical help right away.||
0664|057|B|||
0664|058|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, constipation,||
0664|059|S|stomach upset, blurred vision, decreased coordination, or dry||
0664|060|S|mouth/nose/throat may occur. If any of these effects last or get||
0664|061|S|worse, contact your doctor or pharmacist promptly.||
0664|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
0664|063|S|slowly when rising from a sitting or lying position.||
0664|064|S|   If your doctor has directed you to use this medication,||
0664|065|S|remember that your doctor has judged that the benefit to you is||
0664|066|S|greater than the risk of side effects. Many people using this||
0664|067|S|medication do not have serious side effects.||
0664|068|S|   Tell your doctor right away if you have any serious side||
0664|069|S|effects, including: mental/mood changes (such as hallucinations,||
0664|070|S|irritability, nervousness, confusion), ringing in the ears,||
0664|071|S|trouble urinating, easy bruising/bleeding, fast/irregular||
0664|072|S|heartbeat.||
0664|073|S|   Get medical help right away if you have any very serious side||
0664|074|S|effects, including: seizure.||
0664|075|S|   A very serious allergic reaction to this drug is rare.||
0664|076|S|However, get medical help right away if you notice any symptoms||
0664|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0664|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0664|079|S|breathing.||
0664|080|S|   This is not a complete list of possible side effects. If you||
0664|081|S|notice other effects not listed above, contact your doctor or||
0664|082|S|pharmacist.||
0664|083|S|   In the US -||
0664|084|S|   Call your doctor for medical advice about side effects. You||
0664|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0664|086|S|www.fda.gov/medwatch.||
0664|087|S|   In Canada - Call your doctor for medical advice about side||
0664|088|S|effects. You may report side effects to Health Canada at||
0664|089|S|1-866-234-2345.||
0664|090|B|||
0664|091|P|PRECAUTIONS:  Before taking doxylamine, tell your doctor or||
0664|092|P|pharmacist if you are allergic to it; or if you have any other||
0664|093|P|allergies. This product may contain inactive ingredients, which||
0664|094|P|can cause allergic reactions or other problems. Talk to your||
0664|095|P|pharmacist for more details.||
0664|096|P|   Before using this medication, tell your doctor or pharmacist||
0664|097|P|your medical history, especially of: breathing problems (such as||
0664|098|P|asthma, emphysema), a certain eye problem (glaucoma), heart||
0664|099|P|problems, high blood pressure, liver disease, seizures, stomach||
0664|100|P|problems (such as ulcers, blockage), overactive thyroid||
0664|101|P|(hyperthyroidism), urination problems (such as trouble urinating||
0664|102|P|due to enlarged prostate, urinary retention).||
0664|103|P|   This drug may make you dizzy or drowsy or blur your vision.||
0664|104|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0664|105|P|drowsy. Do not drive, use machinery, or do anything that needs||
0664|106|P|alertness or clear vision until you can do it safely. Avoid||
0664|107|P|alcoholic beverages. Talk to your doctor if you are using||
0664|108|P|marijuana (cannabis).||
0664|109|P|   Liquid products may contain sugar. Caution is advised if you||
0664|110|P|have diabetes. Ask your doctor or pharmacist about using this||
0664|111|P|product safely.||
0664|112|P|   Older adults may be more sensitive to the side effects of this||
0664|113|P|drug, especially drowsiness, dizziness, low blood pressure,||
0664|114|P|confusion, constipation, or trouble urinating. Drowsiness,||
0664|115|P|dizziness, and confusion can increase the risk of falling.||
0664|116|P|   Children may be more sensitive to the effects of||
0664|117|P|antihistamines. In young children, this medication may cause||
0664|118|P|agitation/excitement instead of drowsiness.||
0664|119|P|   This product is safe to use during pregnancy.||
0664|120|P|   Based on information from related drugs, this medication may||
0664|121|P|pass into breast milk. Consult your doctor before breastfeeding.||
0664|122|B|||
0664|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0664|124|I|medications work or increase your risk for serious side effects.||
0664|125|I|This document does not contain all possible drug interactions.||
0664|126|I|Keep a list of all the products you use (including||
0664|127|I|prescription/nonprescription drugs and herbal products) and share||
0664|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
0664|129|I|the dosage of any medicines without your doctor's approval.||
0664|130|I|   Some products that may interact with this drug include:||
0664|131|I|antihistamines applied to the skin (such as diphenhydramine||
0664|132|I|cream, ointment, spray).||
0664|133|I|   Tell your doctor or pharmacist if you are taking other||
0664|134|I|products that cause drowsiness such as opioid pain or cough||
0664|135|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0664|136|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0664|137|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0664|138|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0664|139|I|diphenhydramine).||
0664|140|I|   Check the labels on all your medicines (such as allergy or||
0664|141|I|cough-and-cold products) because they may contain ingredients||
0664|142|I|that cause drowsiness. Ask your pharmacist about using those||
0664|143|I|products safely.||
0664|144|I|   This medication may interfere with certain lab tests (such as||
0664|145|I|urine drug screening tests), possibly causing false test results.||
0664|146|I|Make sure lab personnel and all your doctors know you use this||
0664|147|I|drug.||
0664|148|B|||
0664|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0664|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0664|151|O|poison control center right away. US residents can call||
0664|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0664|153|O|Symptoms of overdose may include: large pupils, flushing, fever,||
0664|154|O|hallucinations, weakness, shaking (tremor), muscle twitching,||
0664|155|O|loss of consciousness, seizures. In children, excitement may||
0664|156|O|occur first, and may be followed by loss of coordination,||
0664|157|O|drowsiness, loss of consciousness, seizures.||
0664|158|B|||
0664|159|N|NOTES:  Do not take for several days before allergy testing||
0664|160|N|because test results can be affected.||
0664|161|N|   Keep all medical and lab appointments.||
0664|162|B|||
0664|163|D|MISSED DOSE:  Not applicable.||
0664|164|B|||
0664|165|R|STORAGE:  Refer to storage information printed on the package. If||
0664|166|R|you have any questions about storage, ask your pharmacist. Keep||
0664|167|R|all products away from children and pets.||
0664|168|R|   Do not flush medications down the toilet or pour them into a||
0664|169|R|drain unless instructed to do so. Properly discard this product||
0664|170|R|when it is expired or no longer needed. Consult your pharmacist||
0664|171|R|or local waste disposal company.||
0664|172|B|||
0664|173|A|Information last revised May 2024.||
0664|174|A|Copyright(c) 2025 First Databank, Inc.||
0664|175|B|||
0665|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0665|002|Z|does NOT have all possible information about this product. This||
0665|003|Z|information does not assure that this product is safe, effective,||
0665|004|Z|or appropriate for you. This information is not individual||
0665|005|Z|medical advice and does not substitute for the advice of your||
0665|006|Z|health care professional. Always ask your health care||
0665|007|Z|professional for complete information about this product and your||
0665|008|Z|specific health needs.||
0665|009|B|||
0665|010|T|TRIPROLIDINE - ORAL||
0665|011|F|(trye-PROE-li-deen)||
0665|012|B|||
0665|013|C|COMMON BRAND NAME(S): Histex, Vanahist PD||
0665|014|B|||
0665|015|U|USES:  Triprolidine is an antihistamine used to relieve symptoms||
0665|016|U|of allergy, hay fever, and the common cold. These symptoms||
0665|017|U|include rash, watery eyes, itchy eyes/nose/throat/skin, cough,||
0665|018|U|runny nose, and sneezing.||
0665|019|U|   This medication works by blocking a certain natural substance||
0665|020|U|(histamine) that your body makes during an allergic reaction. By||
0665|021|U|blocking another natural substance made by your body||
0665|022|U|(acetylcholine), it helps dry up some body fluids to relieve||
0665|023|U|symptoms such as watery eyes and runny nose.||
0665|024|U|   Cough-and-cold products have not been shown to be safe or||
0665|025|U|effective in children younger than 6 years. Do not use this||
0665|026|U|product to treat cold symptoms in children younger than 6 years||
0665|027|U|unless specifically directed by the doctor. Some products (such||
0665|028|U|as long-acting tablets/capsules) are not recommended for use in||
0665|029|U|children younger than 12 years. Ask your doctor or pharmacist for||
0665|030|U|more details about using your product safely.||
0665|031|U|   These products do not cure or shorten the length of the common||
0665|032|U|cold and may cause serious side effects. To decrease the risk for||
0665|033|U|serious side effects, carefully follow all dosage directions. Do||
0665|034|U|not use this product to make a child sleepy. Do not give other||
0665|035|U|cough-and-cold medication that might contain the same or similar||
0665|036|U|ingredients (see also Drug Interactions section). Ask the doctor||
0665|037|U|or pharmacist about other ways to relieve cough and cold symptoms||
0665|038|U|(such as drinking enough fluids, using a humidifier or saline||
0665|039|U|nose drops/spray).||
0665|040|B|||
0665|041|H|HOW TO USE:  Take this medication by mouth with or without food||
0665|042|H|as directed by your doctor, usually every 6 hours. Do not take||
0665|043|H|more than 4 doses in a 24-hour period. Follow all directions on||
0665|044|H|the product package. This medication may be taken with food or||
0665|045|H|milk if stomach upset occurs.||
0665|046|H|   If you are using the liquid form of this medication, carefully||
0665|047|H|measure the dose using a special measuring device/spoon. Do not||
0665|048|H|use a household spoon because you may not get the correct dose.||
0665|049|H|   If you are using the chewable tablets, chew each tablet well||
0665|050|H|and swallow.||
0665|051|H|   The dosage is based on your age, medical condition, and||
0665|052|H|response to treatment. Do not increase your dose or take this||
0665|053|H|medication more often than directed. Do not take more of this||
0665|054|H|medication than recommended for your age. Use this medication||
0665|055|H|regularly to get the most benefit from it. To help you remember,||
0665|056|H|take it at the same times each day.||
0665|057|H|   If your symptoms do not get better after 7 days, if they get||
0665|058|H|worse, if you develop fever/chills, or if you think you may have||
0665|059|H|a serious medical problem, get medical help right away.||
0665|060|B|||
0665|061|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, nausea, vomiting,||
0665|062|S|loss of appetite, constipation, stomach upset, blurred vision,||
0665|063|S|decreased coordination, and dry mouth/nose/throat may occur.||
0665|064|S|These effects may decrease as your body adjusts to the||
0665|065|S|medication. If any of these effects last or get worse, contact||
0665|066|S|your doctor or pharmacist promptly.||
0665|067|S|   To reduce the risk of dizziness and lightheadedness, get up||
0665|068|S|slowly when rising from a sitting or lying position.||
0665|069|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0665|070|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0665|071|S|substitute. Triprolidine can dry up and thicken mucus in your||
0665|072|S|lungs, making it more difficult to breathe and clear your lungs.||
0665|073|S|To help prevent this effect, drink plenty of fluids unless||
0665|074|S|otherwise directed by your doctor.||
0665|075|S|   If your doctor has directed you to use this medication,||
0665|076|S|remember that your doctor has judged that the benefit to you is||
0665|077|S|greater than the risk of side effects. Many people using this||
0665|078|S|medication do not have serious side effects.||
0665|079|S|   Tell your doctor right away if you have any serious side||
0665|080|S|effects, including: mental/mood changes (such as hallucinations,||
0665|081|S|irritability, nervousness), ringing in the ears, trouble||
0665|082|S|urinating, easy bruising/bleeding, fast/irregular heartbeat,||
0665|083|S|seizures.||
0665|084|S|   A very serious allergic reaction to this drug is rare.||
0665|085|S|However, get medical help right away if you notice any symptoms||
0665|086|S|of a serious allergic reaction, including: rash, itching/swelling||
0665|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0665|088|S|breathing.||
0665|089|S|   This is not a complete list of possible side effects. If you||
0665|090|S|notice other effects not listed above, contact your doctor or||
0665|091|S|pharmacist.||
0665|092|S|   In the US -||
0665|093|S|   Call your doctor for medical advice about side effects. You||
0665|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0665|095|S|www.fda.gov/medwatch.||
0665|096|S|   In Canada - Call your doctor for medical advice about side||
0665|097|S|effects. You may report side effects to Health Canada at||
0665|098|S|1-866-234-2345.||
0665|099|B|||
0665|100|P|PRECAUTIONS:  Before taking triprolidine, tell your doctor or||
0665|101|P|pharmacist if you are allergic to it; or if you have any other||
0665|102|P|allergies. This product may contain inactive ingredients, which||
0665|103|P|can cause allergic reactions or other problems. Talk to your||
0665|104|P|pharmacist for more details.||
0665|105|P|   Before using this medication, tell your doctor or pharmacist||
0665|106|P|your medical history, especially of: breathing problems (such as||
0665|107|P|asthma, emphysema), a certain eye problem (glaucoma), heart||
0665|108|P|problems, high blood pressure, liver disease, seizures, stomach||
0665|109|P|problems (such as ulcers, blockage), overactive thyroid||
0665|110|P|(hyperthyroidism), urination problems (such as trouble urinating||
0665|111|P|due to enlarged prostate, urinary retention).||
0665|112|P|   This drug may make you dizzy or drowsy or blur your vision.||
0665|113|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0665|114|P|drowsy. Do not drive, use machinery, or do anything that needs||
0665|115|P|alertness or clear vision until you can do it safely. Avoid||
0665|116|P|alcoholic beverages. Talk to your doctor if you are using||
0665|117|P|marijuana (cannabis).||
0665|118|P|   Liquid products and chewable tablets may contain sugar and/or||
0665|119|P|aspartame. Liquid products may also contain alcohol. Caution is||
0665|120|P|advised if you have diabetes, liver disease, phenylketonuria||
0665|121|P|(PKU), or any other condition that requires you to limit/avoid||
0665|122|P|these substances in your diet. Ask your doctor or pharmacist||
0665|123|P|about using this product safely.||
0665|124|P|   Before having surgery, tell your doctor or dentist about all||
0665|125|P|the products you use (including prescription drugs,||
0665|126|P|nonprescription drugs, and herbal products).||
0665|127|P|   Older adults may be more sensitive to the side effects of this||
0665|128|P|drug, especially dizziness, drowsiness, confusion, and low blood||
0665|129|P|pressure.||
0665|130|P|   Children may be more sensitive to the side effects of||
0665|131|P|antihistamines. In young children, this medication may cause||
0665|132|P|agitation/excitement instead of drowsiness.||
0665|133|P|   During pregnancy, this medication should be used only when||
0665|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
0665|135|P|   This medication passes into breast milk. Consult your doctor||
0665|136|P|before breastfeeding.||
0665|137|B|||
0665|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0665|139|I|medications work or increase your risk for serious side effects.||
0665|140|I|This document does not contain all possible drug interactions.||
0665|141|I|Keep a list of all the products you use (including||
0665|142|I|prescription/nonprescription drugs and herbal products) and share||
0665|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
0665|144|I|the dosage of any medicines without your doctor's approval.||
0665|145|I|   Do not use with antihistamines applied to the skin (such as||
0665|146|I|diphenhydramine cream, ointment, spray) because increased side||
0665|147|I|effects may occur.||
0665|148|I|   Tell your doctor or pharmacist if you are taking other||
0665|149|I|products that cause drowsiness such as opioid pain or cough||
0665|150|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0665|151|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0665|152|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0665|153|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0665|154|I|diphenhydramine).||
0665|155|I|   Check the labels on all your medicines (such as allergy or||
0665|156|I|cough-and-cold products) because they may contain ingredients||
0665|157|I|that cause drowsiness. Ask your pharmacist about using those||
0665|158|I|products safely.||
0665|159|I|   This medication may interfere with certain lab tests (such as||
0665|160|I|allergy skin test), possibly causing false test results. Make||
0665|161|I|sure lab personnel and all your doctors know you use this drug.||
0665|162|B|||
0665|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0665|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0665|165|O|poison control center right away. US residents can call||
0665|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0665|167|O|Symptoms of overdose may include: large pupils, flushing, fever,||
0665|168|O|hallucinations, weakness, shaking (tremor), muscle twitching,||
0665|169|O|loss of consciousness, seizures. In children, excitement may||
0665|170|O|occur first, and may be followed by loss of coordination,||
0665|171|O|drowsiness, loss of consciousness, seizures.||
0665|172|B|||
0665|173|N|NOTES:  Keep all medical and lab appointments.||
0665|174|B|||
0665|175|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0665|176|D|remember. If it is near the time of the next dose, skip the||
0665|177|D|missed dose. Take your next dose at the regular time. Do not||
0665|178|D|double the dose to catch up.||
0665|179|B|||
0665|180|R|STORAGE:  Store at room temperature away from light and moisture.||
0665|181|R|Do not store in the bathroom. Do not freeze. Keep all medications||
0665|182|R|away from children and pets.||
0665|183|R|   Do not flush medications down the toilet or pour them into a||
0665|184|R|drain unless instructed to do so. Properly discard this product||
0665|185|R|when it is expired or no longer needed. Consult your pharmacist||
0665|186|R|or local waste disposal company.||
0665|187|B|||
0665|188|A|Information last revised November 2024.||
0665|189|A|Copyright(c) 2025 First Databank, Inc.||
0665|190|B|||
0666|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0666|002|Z|does NOT have all possible information about this product. This||
0666|003|Z|information does not assure that this product is safe, effective,||
0666|004|Z|or appropriate for you. This information is not individual||
0666|005|Z|medical advice and does not substitute for the advice of your||
0666|006|Z|health care professional. Always ask your health care||
0666|007|Z|professional for complete information about this product and your||
0666|008|Z|specific health needs.||
0666|009|B|||
0666|010|T|DEXCHLORPHENIRAMINE - ORAL||
0666|011|F|(DEX-klor-fen-IR-a-meen)||
0666|012|B|||
0666|013|C|COMMON BRAND NAME(S): Ryclora||
0666|014|B|||
0666|015|U|USES:  Dexchlorpheniramine is an antihistamine used to relieve||
0666|016|U|symptoms of allergy, hay fever, and the common cold. These||
0666|017|U|symptoms may include rash, watery eyes, itchy||
0666|018|U|eyes/nose/throat/skin, cough, runny nose, and sneezing.||
0666|019|U|   This medication works by blocking a certain natural substance||
0666|020|U|(histamine) that your body makes during an allergic reaction. It||
0666|021|U|also blocks another natural substance made by your body||
0666|022|U|(acetylcholine). Blocking acetylcholine helps lessen symptoms||
0666|023|U|such as watery eyes and runny nose.||
0666|024|U|   Cough-and-cold products have not been shown to be safe or||
0666|025|U|effective in children younger than 6 years. Do not use this||
0666|026|U|product to treat cold symptoms in children younger than 6 years||
0666|027|U|unless specifically directed by the doctor. Some products (such||
0666|028|U|as long-acting tablets/capsules) are not recommended for use in||
0666|029|U|children younger than 12 years. Ask your doctor or pharmacist for||
0666|030|U|more details about using your product safely.||
0666|031|U|   These products do not cure or shorten the length of the common||
0666|032|U|cold and may cause serious side effects. To decrease the risk for||
0666|033|U|serious side effects, carefully follow all dosage directions. Do||
0666|034|U|not use this product to make a child sleepy. Do not give other||
0666|035|U|cough-and-cold medications that contain the same or similar||
0666|036|U|ingredients (see also Drug Interactions section). Ask the doctor||
0666|037|U|or pharmacist about other ways to relieve cough and cold symptoms||
0666|038|U|(such as drinking enough fluids, using a humidifier or saline||
0666|039|U|nose drops/spray).||
0666|040|B|||
0666|041|H|HOW TO USE:  Take this medication by mouth with or without food||
0666|042|H|as directed by your doctor, usually every 4 to 6 hours. This||
0666|043|H|medication may be taken with food or milk if stomach upset||
0666|044|H|occurs.||
0666|045|H|   If you are using the liquid form of this medication, carefully||
0666|046|H|measure the dose using a special measuring device/spoon. Do not||
0666|047|H|use a household spoon because you may not get the correct dose.||
0666|048|H|   The dosage is based on your medical condition, age, and||
0666|049|H|response to treatment. Do not increase your dose or take this||
0666|050|H|medication more often than directed. Take this medication||
0666|051|H|regularly to get the most benefit from it. To help you remember,||
0666|052|H|take it at the same times each day.||
0666|053|H|   Tell your doctor if your condition does not get better or if||
0666|054|H|it gets worse.||
0666|055|B|||
0666|056|S|SIDE EFFECTS:  Drowsiness, dizziness, constipation, stomach||
0666|057|S|upset, blurred vision, or dry mouth/nose/throat may occur. If any||
0666|058|S|of these effects last or get worse, tell your doctor or||
0666|059|S|pharmacist promptly.||
0666|060|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0666|061|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0666|062|S|substitute.||
0666|063|S|   Remember that this medication has been prescribed because your||
0666|064|S|doctor has judged that the benefit to you is greater than the||
0666|065|S|risk of side effects. Many people using this medication do not||
0666|066|S|have serious side effects.||
0666|067|S|   Tell your doctor right away if you have any serious side||
0666|068|S|effects, including: mental/mood changes (such as restlessness,||
0666|069|S|confusion), trouble urinating, fast/irregular heartbeat.||
0666|070|S|   Get medical help right away if you have any very serious side||
0666|071|S|effects, including: seizure.||
0666|072|S|   A very serious allergic reaction to this drug is rare.||
0666|073|S|However, get medical help right away if you notice any symptoms||
0666|074|S|of a serious allergic reaction, including: rash, itching/swelling||
0666|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0666|076|S|breathing.||
0666|077|S|   This is not a complete list of possible side effects. If you||
0666|078|S|notice other effects not listed above, contact your doctor or||
0666|079|S|pharmacist.||
0666|080|S|   In the US -||
0666|081|S|   Call your doctor for medical advice about side effects. You||
0666|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0666|083|S|www.fda.gov/medwatch.||
0666|084|S|   In Canada - Call your doctor for medical advice about side||
0666|085|S|effects. You may report side effects to Health Canada at||
0666|086|S|1-866-234-2345.||
0666|087|B|||
0666|088|P|PRECAUTIONS:  Before taking dexchlorpheniramine, tell your doctor||
0666|089|P|or pharmacist if you are allergic to it; or to chlorpheniramine;||
0666|090|P|or if you have any other allergies. This product may contain||
0666|091|P|inactive ingredients, which can cause allergic reactions or other||
0666|092|P|problems. Talk to your pharmacist for more details.||
0666|093|P|   Before using this medication, tell your doctor or pharmacist||
0666|094|P|your medical history, especially of: breathing problems (such as||
0666|095|P|asthma, emphysema), glaucoma, heart problems, high blood||
0666|096|P|pressure, liver disease, seizures, stomach/intestinal problems||
0666|097|P|(such as ulcers, blockage), overactive thyroid (hyperthyroidism),||
0666|098|P|trouble urinating (such as due to enlarged prostate).||
0666|099|P|   This drug may make you dizzy or drowsy or cause blurred||
0666|100|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
0666|101|P|or drowsy. Do not drive, use machinery, or do anything that needs||
0666|102|P|alertness or clear vision until you can do it safely. Limit||
0666|103|P|alcoholic beverages. Talk to your doctor if you are using||
0666|104|P|marijuana (cannabis).||
0666|105|P|   Liquid products may contain alcohol, sugar, and/or aspartame.||
0666|106|P|Caution is advised if you have diabetes, liver disease,||
0666|107|P|phenylketonuria (PKU), or any other condition that requires you||
0666|108|P|to limit/avoid these substances in your diet. Ask your doctor or||
0666|109|P|pharmacist about using this product safely.||
0666|110|P|   Before having surgery, tell your doctor or dentist about all||
0666|111|P|the products you use (including prescription drugs,||
0666|112|P|nonprescription drugs, and herbal products).||
0666|113|P|   Older adults may be more sensitive to the side effects of this||
0666|114|P|drug, especially drowsiness, dizziness, confusion, constipation,||
0666|115|P|or trouble urinating. Drowsiness, dizziness, and confusion can||
0666|116|P|increase the risk of falling.||
0666|117|P|   Children may be more sensitive to the side effects of this||
0666|118|P|drug. This drug can often cause excitement in young children||
0666|119|P|instead of drowsiness.||
0666|120|P|   During pregnancy, this medication should be used only when||
0666|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
0666|122|P|   This medication passes into breast milk and may have||
0666|123|P|undesirable effects on a nursing infant. Consult your doctor||
0666|124|P|before breastfeeding.||
0666|125|B|||
0666|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0666|127|I|medications work or increase your risk for serious side effects.||
0666|128|I|This document does not contain all possible drug interactions.||
0666|129|I|Keep a list of all the products you use (including||
0666|130|I|prescription/nonprescription drugs and herbal products) and share||
0666|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
0666|132|I|the dosage of any medicines without your doctor's approval.||
0666|133|I|   Some products that may interact with this drug are:||
0666|134|I|antihistamines applied to the skin (such as diphenhydramine||
0666|135|I|cream, ointment, spray).||
0666|136|I|   Tell your doctor or pharmacist if you are taking other||
0666|137|I|products that cause drowsiness such as opioid pain or cough||
0666|138|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0666|139|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0666|140|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0666|141|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0666|142|I|diphenhydramine).||
0666|143|I|   Check the labels on all your medicines (such as allergy or||
0666|144|I|cough-and-cold products) because they may contain ingredients||
0666|145|I|that cause drowsiness. Ask your pharmacist about using those||
0666|146|I|products safely.||
0666|147|I|   Dexchlorpheniramine is very similar to chlorpheniramine. Do||
0666|148|I|not use medications containing chlorpheniramine while using||
0666|149|I|dexchlorpheniramine.||
0666|150|I|   This medication may interfere with certain lab tests (such as||
0666|151|I|allergy skin tests), possibly causing false test results. Make||
0666|152|I|sure lab personnel and all your doctors know you use this drug.||
0666|153|B|||
0666|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0666|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0666|156|O|poison control center right away. US residents can call||
0666|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0666|158|O|Symptoms of overdose may include: severe drowsiness, seizures,||
0666|159|O|widened pupils. In children, mental/mood changes (such as||
0666|160|O|restlessness, irritability, hallucinations) may occur before||
0666|161|O|drowsiness.||
0666|162|B|||
0666|163|N|NOTES:  Do not share this medication with others.||
0666|164|B|||
0666|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0666|166|D|remember. If it is near the time of your next dose, skip the||
0666|167|D|missed dose. Take your next dose at the regular time. Do not||
0666|168|D|double the dose to catch up.||
0666|169|B|||
0666|170|R|STORAGE:  Store at room temperature away from light and moisture.||
0666|171|R|Do not freeze liquid forms of this medication. Do not store in||
0666|172|R|the bathroom. Keep all medications away from children and pets.||
0666|173|R|   Do not flush medications down the toilet or pour them into a||
0666|174|R|drain unless instructed to do so. Properly discard this product||
0666|175|R|when it is expired or no longer needed. Consult your pharmacist||
0666|176|R|or local waste disposal company.||
0666|177|B|||
0666|178|A|Information last revised May 2024.||
0666|179|A|Copyright(c) 2025 First Databank, Inc.||
0666|180|B|||
0667|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0667|002|Z|does NOT have all possible information about this product. This||
0667|003|Z|information does not assure that this product is safe, effective,||
0667|004|Z|or appropriate for you. This information is not individual||
0667|005|Z|medical advice and does not substitute for the advice of your||
0667|006|Z|health care professional. Always ask your health care||
0667|007|Z|professional for complete information about this product and your||
0667|008|Z|specific health needs.||
0667|009|B|||
0667|010|T|CHLORPHENIRAMINE - ORAL||
0667|011|F|(klor-fen-EER-a-meen)||
0667|012|B|||
0667|013|C|COMMON BRAND NAME(S): Qdall AR||
0667|014|B|||
0667|015|U|USES:  Chlorpheniramine is an antihistamine used to relieve||
0667|016|U|symptoms of allergy, hay fever, and the common cold. These||
0667|017|U|symptoms include rash, watery eyes, itchy eyes/nose/throat/skin,||
0667|018|U|cough, runny nose, and sneezing.||
0667|019|U|   This medication works by blocking a certain natural substance||
0667|020|U|(histamine) that your body makes during an allergic reaction. By||
0667|021|U|blocking another natural substance made by your body||
0667|022|U|(acetylcholine), it helps dry up some body fluids to relieve||
0667|023|U|symptoms such as watery eyes and runny nose.||
0667|024|U|   Cough-and-cold products have not been shown to be safe or||
0667|025|U|effective in children younger than 6 years. Do not use this||
0667|026|U|product to treat cold symptoms in children younger than 6 years||
0667|027|U|unless specifically directed by the doctor. Some products (such||
0667|028|U|as long-acting tablets/capsules) are not recommended for use in||
0667|029|U|children younger than 12 years. Ask your doctor or pharmacist for||
0667|030|U|more details about using your product safely.||
0667|031|U|   These products do not cure or shorten the length of the common||
0667|032|U|cold and may cause serious side effects. To decrease the risk for||
0667|033|U|serious side effects, carefully follow all dosage directions. Do||
0667|034|U|not use this product to make a child sleepy. Do not give other||
0667|035|U|cough-and-cold medication that might contain the same or similar||
0667|036|U|ingredients (see also Drug Interactions section). Ask the doctor||
0667|037|U|or pharmacist about other ways to relieve cough and cold symptoms||
0667|038|U|(such as drinking enough fluids, using a humidifier or saline||
0667|039|U|nose drops/spray).||
0667|040|B|||
0667|041|H|HOW TO USE:  If you are taking the over-the-counter product, read||
0667|042|H|all directions on the product package before taking this||
0667|043|H|medication. If you have any questions, consult your pharmacist.||
0667|044|H|If your doctor has prescribed this medication, take it as||
0667|045|H|directed.||
0667|046|H|   Take the tablet, capsule, or liquid form by mouth with or||
0667|047|H|without food. Follow the directions for dosing on the label, or||
0667|048|H|take as directed by your doctor. This medication may be taken||
0667|049|H|with food or milk if stomach upset occurs.||
0667|050|H|   If you are taking the extended-release capsules, swallow them||
0667|051|H|whole. Do not crush or chew extended-release capsules or tablets.||
0667|052|H|Doing so can release all of the drug at once, increasing the risk||
0667|053|H|of side effects.||
0667|054|H|   If you are using the liquid form, use a medication measuring||
0667|055|H|device to carefully measure the prescribed dose. Do not use a||
0667|056|H|household spoon. If your liquid form is a suspension, shake the||
0667|057|H|bottle well before each dose.||
0667|058|H|   The dosage is based on your age, medical condition, and||
0667|059|H|response to treatment. Do not increase your dose or take this||
0667|060|H|medication more often than recommended by your doctor or the||
0667|061|H|package instructions without your doctor's approval. Take this||
0667|062|H|medication regularly in order to get the most benefit from it. To||
0667|063|H|help you remember, take it at the same time(s) each day.||
0667|064|H|   If your condition lasts or gets worse, or if you think you may||
0667|065|H|have a serious medical problem, get medical help right away.||
0667|066|B|||
0667|067|S|SIDE EFFECTS:  Drowsiness, dizziness, constipation, stomach||
0667|068|S|upset, blurred vision, or dry mouth/nose/throat may occur. If any||
0667|069|S|of these effects last or get worse, tell your doctor or||
0667|070|S|pharmacist promptly.||
0667|071|S|   To reduce the risk of dizziness and lightheadedness, get up||
0667|072|S|slowly when rising from a sitting or lying position.||
0667|073|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0667|074|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0667|075|S|substitute.||
0667|076|S|   If you are using a sustained-release product, an empty tablet||
0667|077|S|shell may appear in your stool. This is harmless.||
0667|078|S|   If your doctor has prescribed this medication, remember that||
0667|079|S|your doctor has judged that the benefit to you is greater than||
0667|080|S|the risk of side effects. Many people using this medication do||
0667|081|S|not have serious side effects.||
0667|082|S|   Tell your doctor right away if you have any serious side||
0667|083|S|effects, including: mental/mood changes (such as restlessness,||
0667|084|S|confusion), trouble urinating, fast/irregular heartbeat.||
0667|085|S|   Get medical help right away if you have any very serious side||
0667|086|S|effects, including: seizure.||
0667|087|S|   A very serious allergic reaction to this drug is rare.||
0667|088|S|However, get medical help right away if you notice any symptoms||
0667|089|S|of a serious allergic reaction, including: rash, itching/swelling||
0667|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0667|091|S|breathing.||
0667|092|S|   This is not a complete list of possible side effects. If you||
0667|093|S|notice other effects not listed above, contact your doctor or||
0667|094|S|pharmacist.||
0667|095|S|   In the US -||
0667|096|S|   Call your doctor for medical advice about side effects. You||
0667|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0667|098|S|www.fda.gov/medwatch.||
0667|099|S|   In Canada - Call your doctor for medical advice about side||
0667|100|S|effects. You may report side effects to Health Canada at||
0667|101|S|1-866-234-2345.||
0667|102|B|||
0667|103|P|PRECAUTIONS:  Before taking chlorpheniramine, tell your doctor or||
0667|104|P|pharmacist if you are allergic to it; or to dexchlorpheniramine;||
0667|105|P|or if you have any other allergies. This product may contain||
0667|106|P|inactive ingredients, which can cause allergic reactions or other||
0667|107|P|problems. Talk to your pharmacist for more details.||
0667|108|P|   Before using this medication, tell your doctor or pharmacist||
0667|109|P|your medical history, especially of: breathing problems (such as||
0667|110|P|asthma, emphysema), glaucoma, heart problems, high blood||
0667|111|P|pressure, liver disease, seizures, stomach/intestinal problems||
0667|112|P|(such as ulcers, blockage), overactive thyroid (hyperthyroidism),||
0667|113|P|trouble urinating (such as due to enlarged prostate).||
0667|114|P|   This drug may make you dizzy or drowsy or blur your vision.||
0667|115|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0667|116|P|drowsy. Do not drive, use machinery, or do anything that needs||
0667|117|P|alertness or clear vision until you can do it safely. Limit||
0667|118|P|alcoholic beverages. Talk to your doctor if you are using||
0667|119|P|marijuana (cannabis).||
0667|120|P|   Liquid products may contain aspartame, sugar and/or alcohol.||
0667|121|P|Caution is advised if you have diabetes, alcohol dependence,||
0667|122|P|liver disease, phenylketonuria (PKU), or any other condition that||
0667|123|P|requires you to limit/avoid these substances in your diet. Ask||
0667|124|P|your doctor or pharmacist about using this product safely.||
0667|125|P|   Before having surgery, tell your doctor or dentist about all||
0667|126|P|the products you use (including prescription drugs,||
0667|127|P|nonprescription drugs, and herbal products).||
0667|128|P|   Older adults may be more sensitive to the side effects of this||
0667|129|P|drug, especially drowsiness, dizziness, confusion, constipation,||
0667|130|P|or trouble urinating. Drowsiness, dizziness, and confusion can||
0667|131|P|increase the risk of falling.||
0667|132|P|   Children may be more sensitive to the side effects of this||
0667|133|P|drug. This drug can often cause excitement in young children||
0667|134|P|instead of drowsiness.||
0667|135|P|   During pregnancy, this medication should be used only when||
0667|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
0667|137|P|   Based on information from related drugs, this medication may||
0667|138|P|pass into breast milk. Consult your doctor before breastfeeding.||
0667|139|B|||
0667|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0667|141|I|medications work or increase your risk for serious side effects.||
0667|142|I|This document does not contain all possible drug interactions.||
0667|143|I|Keep a list of all the products you use (including||
0667|144|I|prescription/nonprescription drugs and herbal products) and share||
0667|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
0667|146|I|the dosage of any medicines without your doctor's approval.||
0667|147|I|   Some products that may interact with this drug are:||
0667|148|I|antihistamines applied to the skin (such as diphenhydramine||
0667|149|I|cream, ointment, spray).||
0667|150|I|   Tell your doctor or pharmacist if you are taking other||
0667|151|I|products that cause drowsiness such as opioid pain or cough||
0667|152|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0667|153|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0667|154|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0667|155|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
0667|156|I|diphenhydramine).||
0667|157|I|   Check the labels on all your medicines (such as allergy or||
0667|158|I|cough-and-cold products) because they may contain ingredients||
0667|159|I|that cause drowsiness. Ask your pharmacist about using those||
0667|160|I|products safely.||
0667|161|I|   Chlorpheniramine is very similar to dexchlorpheniramine. Do||
0667|162|I|not use medications containing dexchlorpheniramine while using||
0667|163|I|chlorpheniramine.||
0667|164|I|   This medication may interfere with certain lab tests (such as||
0667|165|I|allergy skin testing), possibly causing false test results. Make||
0667|166|I|sure lab personnel and all your doctors know you use this drug.||
0667|167|B|||
0667|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0667|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0667|170|O|poison control center right away. US residents can call||
0667|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0667|172|O|Symptoms of overdose may include: large pupils, flushing, fever,||
0667|173|O|hallucinations, weakness, shaking (tremor), muscle twitching,||
0667|174|O|loss of consciousness, seizures. In children, excitement may||
0667|175|O|occur first, and may be followed by loss of coordination,||
0667|176|O|drowsiness, loss of consciousness, seizures.||
0667|177|B|||
0667|178|N|NOTES:  If your doctor has prescribed this medication, do not||
0667|179|N|share it with others.||
0667|180|N|   Keep all medical and lab appointments.||
0667|181|B|||
0667|182|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0667|183|D|remember. If it is near the time of your next dose, skip the||
0667|184|D|missed dose. Take your next dose at the regular time. Do not||
0667|185|D|double the dose to catch up.||
0667|186|B|||
0667|187|R|STORAGE:  Store at room temperature away from moisture and light.||
0667|188|R|Do not store in the bathroom. Do not freeze liquid forms of this||
0667|189|R|medication. Keep all medications away from children and pets.||
0667|190|R|   Do not flush medications down the toilet or pour them into a||
0667|191|R|drain unless instructed to do so. Properly discard this product||
0667|192|R|when it is expired or no longer needed. Consult your pharmacist||
0667|193|R|or local waste disposal company.||
0667|194|B|||
0667|195|A|Information last revised June 2024.||
0667|196|A|Copyright(c) 2025 First Databank, Inc.||
0667|197|B|||
0670|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0670|002|Z|does NOT have all possible information about this product. This||
0670|003|Z|information does not assure that this product is safe, effective,||
0670|004|Z|or appropriate for you. This information is not individual||
0670|005|Z|medical advice and does not substitute for the advice of your||
0670|006|Z|health care professional. Always ask your health care||
0670|007|Z|professional for complete information about this product and your||
0670|008|Z|specific health needs.||
0670|009|B|||
0670|010|T|INSULIN HUMAN ISOPHANE SUSPENSION 70/REGULAR 30 - INJECTION||
0670|011|F|(IN-su-lin HUE-man EYE-soe-fane 70/Regular 30)||
0670|012|B|||
0670|013|C|COMMON BRAND NAME(S): Humulin 70-30, Novolin 70-30||
0670|014|B|||
0670|015|U|USES:  Combination isophane/regular insulin is used with a proper||
0670|016|U|diet and exercise program to control high blood sugar in people||
0670|017|U|with diabetes. Controlling high blood sugar helps prevent kidney||
0670|018|U|damage, blindness, nerve problems, loss of limbs, and sexual||
0670|019|U|function problems. Proper control of diabetes may also lessen||
0670|020|U|your risk of a heart attack or stroke.||
0670|021|U|   This man-made insulin product is the same as human insulin. It||
0670|022|U|replaces the insulin that your body would normally make. It is a||
0670|023|U|mixture of 70% intermediate-acting insulin (isophane) and 30%||
0670|024|U|short-acting insulin (regular). It starts to work as quickly as||
0670|025|U|regular insulin but lasts longer. This insulin product works by||
0670|026|U|helping blood sugar (glucose) get into cells so your body can use||
0670|027|U|it for energy. This product may be used alone or with other oral||
0670|028|U|diabetes drugs (such as metformin).||
0670|029|B|||
0670|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0670|031|H|from your pharmacist before you start using this medication and||
0670|032|H|each time you get a refill. Ask your health care professional how||
0670|033|H|to prepare and use this medication. If you have any questions,||
0670|034|H|ask your doctor or pharmacist.||
0670|035|H|   Inject this medication under the skin as directed by your||
0670|036|H|doctor, usually once or twice a day. The injection is given in||
0670|037|H|the stomach area, the thigh, the buttocks, or the back of the||
0670|038|H|upper arm. Do not inject into a vein or muscle because very low||
0670|039|H|blood sugar (hypoglycemia) may occur.||
0670|040|H|   The dosage is based on your medical condition and response to||
0670|041|H|treatment. Measure each dose very carefully because even small||
0670|042|H|changes in the amount of insulin may have a large effect on your||
0670|043|H|blood sugar.||
0670|044|H|   Before using, gently roll the vial or cartridge, turning it||
0670|045|H|upside down and back 10 times to mix the medication. Do not shake||
0670|046|H|the container. Check this product for particles or discoloration.||
0670|047|H|If either is present, do not use the insulin. Combination||
0670|048|H|isophane/regular insulin should look evenly cloudy/milky after||
0670|049|H|mixing. Do not use if you see clumps of white material, a||
0670|050|H|"frosty" appearance, or particles stuck to the sides of the vial||
0670|051|H|or cartridge.||
0670|052|H|   Before injecting each dose, clean the skin you are going to||
0670|053|H|inject into (the injection site) with rubbing alcohol. Change the||
0670|054|H|injection site each time to lessen injury under the skin (for||
0670|055|H|example, pits/lumps or thickened skin). Do not inject into skin||
0670|056|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
0670|057|H|not rub the injection site after a shot. Do not inject cold||
0670|058|H|insulin because this can be painful. The insulin container you||
0670|059|H|are currently using can be kept at room temperature. Learn how to||
0670|060|H|store and discard medical supplies safely.||
0670|061|H|   This product should not be mixed with any other insulin.||
0670|062|H|   Do not change brands or types of insulin without directions on||
0670|063|H|how to do so from your doctor.||
0670|064|H|   Do not share your pen device with another person, even if the||
0670|065|H|needle is changed. You may give other people a serious infection,||
0670|066|H|or get a serious infection from them.||
0670|067|H|   Use this medication regularly to get the most benefit from it.||
0670|068|H|To help you remember, use it at the same time(s) each day.||
0670|069|H|   Tell your doctor if your condition does not get better or if||
0670|070|H|it gets worse (your blood sugar is too high or too low).||
0670|071|B|||
0670|072|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
0670|073|S|irritation) or weight gain may occur. If any of these effects||
0670|074|S|last or get worse, tell your doctor or pharmacist promptly.||
0670|075|S|   Remember that this medication has been prescribed because your||
0670|076|S|doctor has judged that the benefit to you is greater than the||
0670|077|S|risk of side effects. Many people using this medication do not||
0670|078|S|have serious side effects.||
0670|079|S|   Tell your doctor right away if you have any serious side||
0670|080|S|effects, including: signs of low potassium level in the blood||
0670|081|S|(such as muscle cramps, weakness, irregular heartbeat).||
0670|082|S|   This medication can cause low blood sugar (hypoglycemia). This||
0670|083|S|may occur if you do not get enough calories from food or if you||
0670|084|S|do unusually heavy exercise. Symptoms of low blood sugar include||
0670|085|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
0670|086|S|dizziness, or tingling hands/feet. It is a good habit to carry||
0670|087|S|glucose tablets or gel to treat low blood sugar. If you don't||
0670|088|S|have these reliable forms of glucose, rapidly raise your blood||
0670|089|S|sugar by eating a quick source of sugar such as table sugar,||
0670|090|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
0670|091|S|doctor right away about the reaction and the use of this product.||
0670|092|S|To help prevent low blood sugar, eat meals on a regular schedule,||
0670|093|S|and do not skip meals. Check with your doctor or pharmacist to||
0670|094|S|find out what you should do if you miss a meal.||
0670|095|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0670|096|S|thirst/urination. If these symptoms occur, tell your doctor right||
0670|097|S|away. Your doctor may need to adjust your diabetes medication,||
0670|098|S|exercise program, or diet.||
0670|099|S|   A very serious allergic reaction to this drug is rare.||
0670|100|S|However, get medical help right away if you notice any symptoms||
0670|101|S|of a serious allergic reaction, including: rash, itching/swelling||
0670|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0670|103|S|breathing.||
0670|104|S|   This is not a complete list of possible side effects. If you||
0670|105|S|notice other effects not listed above, contact your doctor or||
0670|106|S|pharmacist.||
0670|107|S|   In the US -||
0670|108|S|   Call your doctor for medical advice about side effects. You||
0670|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0670|110|S|www.fda.gov/medwatch.||
0670|111|S|   In Canada - Call your doctor for medical advice about side||
0670|112|S|effects. You may report side effects to Health Canada at||
0670|113|S|1-866-234-2345.||
0670|114|B|||
0670|115|P|PRECAUTIONS:  Before using combination isophane/regular insulin,||
0670|116|P|tell your doctor or pharmacist if you are allergic to it; or to||
0670|117|P|other types of insulins; or if you have any other allergies. This||
0670|118|P|product may contain inactive ingredients, which can cause||
0670|119|P|allergic reactions or other problems. Talk to your pharmacist for||
0670|120|P|more details.||
0670|121|P|   Do not use this medication when you have low blood sugar||
0670|122|P|(hypoglycemia).||
0670|123|P|   Before using this medication, tell your doctor or pharmacist||
0670|124|P|your medical history, especially of: adrenal/pituitary gland||
0670|125|P|problems, kidney disease, liver disease, thyroid problems.||
0670|126|P|   You may experience blurred vision, dizziness, or drowsiness||
0670|127|P|due to extremely low or high blood sugar. Do not drive, use||
0670|128|P|machinery, or do anything that needs alertness or clear vision||
0670|129|P|until you can do it safely.||
0670|130|P|   Limit alcohol while using this medication because it can||
0670|131|P|increase your risk of developing low blood sugar.||
0670|132|P|   It may be harder to control your blood sugar when your body is||
0670|133|P|stressed (such as due to fever, infection, injury, or surgery).||
0670|134|P|Consult your doctor because this may require a change in your||
0670|135|P|treatment plan, medications, or blood sugar testing.||
0670|136|P|   Before having surgery, tell your doctor or dentist about all||
0670|137|P|the products you use (including prescription drugs,||
0670|138|P|nonprescription drugs, and herbal products).||
0670|139|P|   Check your blood sugar before and after exercise. You may need||
0670|140|P|a snack before exercising.||
0670|141|P|   If traveling across time zones, ask your doctor about how to||
0670|142|P|adjust your insulin schedule. Take extra insulin and supplies||
0670|143|P|with you.||
0670|144|P|   Older adults may be more sensitive to the side effects of this||
0670|145|P|drug, especially low blood sugar.||
0670|146|P|   Children may be more sensitive to the side effects of this||
0670|147|P|drug, especially low blood sugar.||
0670|148|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
0670|149|P|cause or worsen diabetes. Discuss a plan with your doctor for||
0670|150|P|managing your blood sugar while pregnant. Your doctor may change||
0670|151|P|your diabetes treatment during your pregnancy (such as diet and||
0670|152|P|medications including insulin).||
0670|153|P|   This medication passes into breast milk, but is unlikely to||
0670|154|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0670|155|P|Your insulin needs may change while breastfeeding.||
0670|156|B|||
0670|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0670|158|I|medications work or increase your risk for serious side effects.||
0670|159|I|This document does not contain all possible drug interactions.||
0670|160|I|Keep a list of all the products you use (including||
0670|161|I|prescription/nonprescription drugs and herbal products) and share||
0670|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
0670|163|I|the dosage of any medicines without your doctor's approval.||
0670|164|I|   A product that may interact with this drug is: repaglinide.||
0670|165|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0670|166|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0670|167|I|heartbeat you would usually feel when your blood sugar falls too||
0670|168|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0670|169|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0670|170|I|   Many drugs can affect your blood sugar levels, making it more||
0670|171|I|difficult to control your blood sugar. Before you start, stop, or||
0670|172|I|change any medication, talk with your doctor or pharmacist about||
0670|173|I|how the medication may affect your blood sugar. Check your blood||
0670|174|I|sugar regularly as directed by your doctor. Tell your doctor||
0670|175|I|about the results and of any symptoms of high or low blood sugar.||
0670|176|I|(See also Side Effects section.) Your doctor may need to adjust||
0670|177|I|your diabetes medication, exercise program, or diet.||
0670|178|B|||
0670|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0670|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0670|181|O|poison control center right away. US residents can call||
0670|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0670|183|O|Symptoms of overdose may include: signs of low blood sugar such||
0670|184|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
0670|185|B|||
0670|186|N|NOTES:  Do not share this medication, needles, or syringes with||
0670|187|N|others.||
0670|188|N|   Attend a diabetes education program to learn more about how to||
0670|189|N|manage your diabetes with medications, diet, exercise, and||
0670|190|N|regular medical exams.||
0670|191|N|   Learn the symptoms of high and low blood sugar and how to||
0670|192|N|treat low blood sugar. Check your blood sugar regularly as||
0670|193|N|directed and share the results with your doctor.||
0670|194|N|   Lab and/or medical tests (such as liver/kidney function,||
0670|195|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
0670|196|N|should be done while you are taking this medication. Keep all||
0670|197|N|medical and lab appointments.||
0670|198|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
0670|199|B|||
0670|200|D|MISSED DOSE:  It is very important to follow your insulin regimen||
0670|201|D|exactly. Ask your doctor ahead of time what you should do if you||
0670|202|D|miss a dose of insulin.||
0670|203|B|||
0670|204|R|STORAGE:  Different brands of this medication have different||
0670|205|R|storage needs. Check the product package for instructions on how||
0670|206|R|to store your brand, or ask your pharmacist. Protect insulin from||
0670|207|R|light and heat. Do not store in the bathroom. Do not freeze, and||
0670|208|R|do not use insulin that has been frozen. Throw away all insulin||
0670|209|R|products after the expiration date on the package, or after the||
0670|210|R|specified number of days after it has been opened or kept at room||
0670|211|R|temperature, whichever date is earlier. Keep all medications away||
0670|212|R|from children and pets.||
0670|213|R|   Do not flush medications down the toilet or pour them into a||
0670|214|R|drain unless instructed to do so. Properly discard this product||
0670|215|R|when it is expired or no longer needed. Consult your pharmacist||
0670|216|R|or local waste disposal company.||
0670|217|B|||
0670|218|M|MEDICAL ALERT:  Your condition can cause complications in a||
0670|219|M|medical emergency. For information about enrolling in MedicAlert,||
0670|220|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0670|221|B|||
0670|222|A|Information last revised April 2025.||
0670|223|A|Copyright(c) 2025 First Databank, Inc.||
0670|224|B|||
0674|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0674|002|Z|does NOT have all possible information about this product. This||
0674|003|Z|information does not assure that this product is safe, effective,||
0674|004|Z|or appropriate for you. This information is not individual||
0674|005|Z|medical advice and does not substitute for the advice of your||
0674|006|Z|health care professional. Always ask your health care||
0674|007|Z|professional for complete information about this product and your||
0674|008|Z|specific health needs.||
0674|009|B|||
0674|010|T|POTASSIUM EXTENDED-RELEASE - ORAL||
0674|011|F|(poe-TAS-ee-um)||
0674|012|B|||
0674|013|C|COMMON BRAND NAME(S): Micro-K||
0674|014|B|||
0674|015|U|USES:  This medication is a mineral supplement used to treat or||
0674|016|U|prevent low amounts of potassium in the blood. A normal level of||
0674|017|U|potassium in the blood is important. Potassium helps your cells,||
0674|018|U|kidneys, heart, muscles, and nerves work properly. Most people||
0674|019|U|get enough potassium by eating a well-balanced diet. Some||
0674|020|U|conditions that can lower your body's potassium level include||
0674|021|U|severe prolonged diarrhea and vomiting, hormone problems such as||
0674|022|U|hyperaldosteronism, or treatment with "water pills"/diuretics.||
0674|023|B|||
0674|024|H|HOW TO USE:  Take this medication by mouth as directed by your||
0674|025|H|doctor. To prevent stomach upset, take each dose with a meal and||
0674|026|H|a full glass of water (8 ounces/240 milliliters) unless your||
0674|027|H|doctor directs you otherwise. Do not lie down for at least 10||
0674|028|H|minutes after taking this medication.||
0674|029|H|   Swallow the capsules or tablets whole. Do not crush, or chew||
0674|030|H|extended-release capsules or tablets. Doing so can release all of||
0674|031|H|the drug at once, increasing the risk of side effects.||
0674|032|H|   Swallow the capsules whole. If you have trouble swallowing the||
0674|033|H|capsules, tell your doctor or pharmacist. Some brands may be||
0674|034|H|opened and the contents sprinkled onto a spoonful of cool, soft||
0674|035|H|food such as applesauce or pudding. Immediately swallow the||
0674|036|H|food/medication mixture without chewing. Do not prepare the||
0674|037|H|mixture ahead of time. Drink a glass of cool water after each||
0674|038|H|dose to make sure you swallow all the medication. Ask your||
0674|039|H|pharmacist if you have questions about your brand.||
0674|040|H|   Take this medication regularly to get the most benefit from||
0674|041|H|it. To help you remember, take it at the same time(s) each day.||
0674|042|H|The dosage is based on your medical condition and response to||
0674|043|H|treatment. Do not increase your dose or take it more often than||
0674|044|H|prescribed. Do not take more than 20 milliequivalents per dose.||
0674|045|H|   Tell your doctor if your condition does not get better or if||
0674|046|H|you have symptoms of low potassium in the blood (such as||
0674|047|H|irregular heartbeat, muscle weakness/cramps).||
0674|048|B|||
0674|049|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, gas, or diarrhea||
0674|050|S|may occur. If any of these effects last or get worse, tell your||
0674|051|S|doctor or pharmacist promptly.||
0674|052|S|   An empty tablet or capsule shell may appear in your stool.||
0674|053|S|This effect is harmless because your body has already absorbed||
0674|054|S|the medication.||
0674|055|S|   Remember that this medication has been prescribed because your||
0674|056|S|doctor has judged that the benefit to you is greater than the||
0674|057|S|risk of side effects. Many people using this medication do not||
0674|058|S|have serious side effects.||
0674|059|S|   Tell your doctor right away if you have any serious side||
0674|060|S|effects, including: difficult/painful swallowing, feeling as if||
0674|061|S|the capsule/tablet is stuck in your throat.||
0674|062|S|   Get medical help right away if you have any very serious side||
0674|063|S|effects, including: vomit that looks like coffee grounds,||
0674|064|S|stomach/abdominal pain, black/tarry stools.||
0674|065|S|   A very serious allergic reaction to this drug is rare.||
0674|066|S|However, get medical help right away if you notice any symptoms||
0674|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0674|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0674|069|S|breathing.||
0674|070|S|   This is not a complete list of possible side effects. If you||
0674|071|S|notice other effects not listed above, contact your doctor or||
0674|072|S|pharmacist.||
0674|073|S|   In the US -||
0674|074|S|   Call your doctor for medical advice about side effects. You||
0674|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0674|076|S|www.fda.gov/medwatch.||
0674|077|S|   In Canada - Call your doctor for medical advice about side||
0674|078|S|effects. You may report side effects to Health Canada at||
0674|079|S|1-866-234-2345.||
0674|080|B|||
0674|081|P|PRECAUTIONS:  Before taking potassium, tell your doctor or||
0674|082|P|pharmacist if you have any allergies. This product may contain||
0674|083|P|inactive ingredients, which can cause allergic reactions or other||
0674|084|P|problems. Talk to your pharmacist for more details.||
0674|085|P|   Before using this medication, tell your doctor or pharmacist||
0674|086|P|your medical history, especially of: heart problems, kidney||
0674|087|P|problems, high levels of potassium in the blood.||
0674|088|P|   Due to rare reports of stomach/intestinal ulcers and bleeding||
0674|089|P|with sustained-release potassium products, taking a liquid form||
0674|090|P|of potassium is preferred. Tell your doctor or pharmacist if you||
0674|091|P|have throat/stomach/intestinal problems such as blockage,||
0674|092|P|narrowing, or ulcers.||
0674|093|P|   Before having surgery, tell your doctor or dentist about all||
0674|094|P|the products you use (including prescription drugs,||
0674|095|P|nonprescription drugs, and herbal products).||
0674|096|P|   Before using other potassium supplements or salt substitutes||
0674|097|P|that contain potassium, consult your doctor or pharmacist. Too||
0674|098|P|much potassium may cause serious side effects. (See also Overdose||
0674|099|P|section.)||
0674|100|P|   During pregnancy, this medication should be used only when||
0674|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
0674|102|P|   Potassium passes into breast milk. Consult your doctor before||
0674|103|P|breastfeeding.||
0674|104|B|||
0674|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0674|106|I|medications work or increase your risk for serious side effects.||
0674|107|I|This document does not contain all possible drug interactions.||
0674|108|I|Keep a list of all the products you use (including||
0674|109|I|prescription/nonprescription drugs and herbal products) and share||
0674|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0674|111|I|the dosage of any medicines without your doctor's approval.||
0674|112|I|   Tell your doctor or pharmacist if you are regularly taking||
0674|113|I|other medications that can also raise your potassium level.||
0674|114|I|Examples include drospirenone, eplerenone, ACE inhibitors (such||
0674|115|I|as enalapril, lisinopril), angiotensin receptor blockers (such as||
0674|116|I|losartan, valsartan), potassium-sparing "water pills"/diuretics||
0674|117|I|(such as spironolactone, triamterene), among others.||
0674|118|I|   Also, tell your doctor or pharmacist if you take medications||
0674|119|I|that can slow down the movement of potassium in your stomach or||
0674|120|I|intestines, possibly increasing the risk of side effects (such as||
0674|121|I|ulcers). Examples include atropine, scopolamine, some||
0674|122|I|antihistamines such as diphenhydramine, antispasmodic drugs such||
0674|123|I|as dicyclomine/hyoscyamine, bladder control drugs such as||
0674|124|I|oxybutynin/tolterodine, certain drugs for Parkinson's disease||
0674|125|I|such as benztropine/trihexyphenidyl, among others.||
0674|126|B|||
0674|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0674|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0674|129|O|poison control center right away. US residents can call||
0674|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0674|131|O|Symptoms of overdose may include irregular heartbeat, muscle||
0674|132|O|weakness, confusion.||
0674|133|B|||
0674|134|N|NOTES:  Do not share this medication with others.||
0674|135|N|   Lab and/or medical tests (such as potassium blood level,||
0674|136|N|kidney function) should be done while you are taking this||
0674|137|N|medication. Keep all medical and lab appointments. Consult your||
0674|138|N|doctor for more details.||
0674|139|N|   Eat a well-balanced diet. Foods high in potassium include||
0674|140|N|bananas, oranges, cantaloupe, raisins, dates, prunes, avocados,||
0674|141|N|apricots, beans, broccoli, spinach, potatoes, lentils, chicken,||
0674|142|N|turkey, beef, and yogurt. Consult your doctor or dietician for||
0674|143|N|recommended foods.||
0674|144|B|||
0674|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0674|146|D|remember. If it is near the time of the next dose, skip the||
0674|147|D|missed dose. Take your next dose at the regular time. Do not||
0674|148|D|double the dose to catch up.||
0674|149|B|||
0674|150|R|STORAGE:  Store at room temperature away from light and moisture.||
0674|151|R|Do not store in the bathroom. Keep all medications away from||
0674|152|R|children and pets.||
0674|153|R|   Do not flush medications down the toilet or pour them into a||
0674|154|R|drain unless instructed to do so. Properly discard this product||
0674|155|R|when it is expired or no longer needed. Consult your pharmacist||
0674|156|R|or local waste disposal company.||
0674|157|B|||
0674|158|A|Information last revised November 2024.||
0674|159|A|Copyright(c) 2025 First Databank, Inc.||
0674|160|B|||
0678|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0678|002|Z|does NOT have all possible information about this product. This||
0678|003|Z|information does not assure that this product is safe, effective,||
0678|004|Z|or appropriate for you. This information is not individual||
0678|005|Z|medical advice and does not substitute for the advice of your||
0678|006|Z|health care professional. Always ask your health care||
0678|007|Z|professional for complete information about this product and your||
0678|008|Z|specific health needs.||
0678|009|B|||
0678|010|T|TERCONAZOLE CREAM, SUPPOSITORY - VAGINAL||
0678|011|F|(ter-KONE-a-zole)||
0678|012|B|||
0678|013|C|COMMON BRAND NAME(S): Terazol 3, Terazol 7||
0678|014|B|||
0678|015|U|USES:  This medication is used to treat vaginal yeast infections.||
0678|016|U|Terconazole reduces vaginal burning, itching, and discharge that||
0678|017|U|may occur with this condition. This medication is an azole||
0678|018|U|antifungal. It works by stopping the growth of yeast (fungus)||
0678|019|U|that causes the infection.||
0678|020|U|   If you have fever, chills, flu-like symptoms,||
0678|021|U|stomach/abdominal pain, or a bad-smelling vaginal discharge, do||
0678|022|U|not use this medication. Contact your doctor right away because||
0678|023|U|these may be signs of a more serious infection.||
0678|024|B|||
0678|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0678|026|H|from your pharmacist before you start using terconazole and each||
0678|027|H|time you get a refill. If you have any questions, ask your doctor||
0678|028|H|or pharmacist.||
0678|029|H|   This product is for vaginal use only. Wash your hands before||
0678|030|H|and after use. Avoid contact with your eyes. If it gets into your||
0678|031|H|eyes, wash them right away with plenty of water. Call your doctor||
0678|032|H|if eye irritation lasts.||
0678|033|H|   Use this product as directed by your doctor, usually once||
0678|034|H|daily at bedtime for 3 or 7 days (depending on product). The||
0678|035|H|dosage and length of treatment is based on your medical condition||
0678|036|H|and response to treatment.||
0678|037|H|   Learn all preparation and usage instructions in the product||
0678|038|H|package. If using the cream, use the applicator. If using the||
0678|039|H|suppository, you may use either the applicator or your finger to||
0678|040|H|insert it. Unwrap the suppository before use. Follow the package||
0678|041|H|instructions on how to fill the applicator with the cream or with||
0678|042|H|a suppository. Lie on your back with your knees toward your||
0678|043|H|chest. Insert the applicator or suppository into the vagina as||
0678|044|H|far as it will comfortably go. Slowly press the plunger of the||
0678|045|H|applicator in to release the medication. Clean the applicator||
0678|046|H|with warm soapy water, rinse well, and dry. If you have||
0678|047|H|itching/burning around the outside of the vagina (vulva), you may||
0678|048|H|also apply terconazole cream once daily to that area and rub in.||
0678|049|H|   Continue to use this medication every day until the full||
0678|050|H|prescribed amount is finished, even if symptoms disappear after 1||
0678|051|H|to 2 days. Stopping the medication too early may result in a||
0678|052|H|return of the infection.||
0678|053|H|   You may use this product during your menstrual period. Do not||
0678|054|H|use tampons or douches while using this medication. Unscented||
0678|055|H|sanitary napkins may be used for your menstrual period or to||
0678|056|H|protect your clothing from leakage of the medication.||
0678|057|H|   Tell your doctor if your condition does not get better or if||
0678|058|H|it returns within 2 months. You may need a different or||
0678|059|H|additional medication to treat your condition.||
0678|060|B|||
0678|061|S|SIDE EFFECTS:  Headache, increased vaginal/urethral||
0678|062|S|burning/itching/pain, or menstrual cramps may occur. If any of||
0678|063|S|these effects last or get worse, notify your doctor or pharmacist||
0678|064|S|promptly.||
0678|065|S|   Remember that this medication has been prescribed because your||
0678|066|S|doctor has judged that the benefit to you is greater than the||
0678|067|S|risk of side effects. Many people using this medication do not||
0678|068|S|have serious side effects.||
0678|069|S|   A very serious allergic reaction to this drug is rare.||
0678|070|S|However, get medical help right away if you notice any symptoms||
0678|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0678|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0678|073|S|breathing.||
0678|074|S|   This is not a complete list of possible side effects. If you||
0678|075|S|notice other effects not listed above, contact your doctor or||
0678|076|S|pharmacist.||
0678|077|S|   In the US -||
0678|078|S|   Call your doctor for medical advice about side effects. You||
0678|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0678|080|S|www.fda.gov/medwatch.||
0678|081|S|   In Canada - Call your doctor for medical advice about side||
0678|082|S|effects. You may report side effects to Health Canada at||
0678|083|S|1-866-234-2345.||
0678|084|B|||
0678|085|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0678|086|P|pharmacist if you are allergic to it; or to other azole||
0678|087|P|antifungal agents (such as clotrimazole, fluconazole); or if you||
0678|088|P|have any other allergies. This product may contain inactive||
0678|089|P|ingredients, which can cause allergic reactions or other||
0678|090|P|problems. Talk to your pharmacist for more details.||
0678|091|P|   Before using this medication, tell your doctor or pharmacist||
0678|092|P|your medical history, especially of: diabetes, immune system||
0678|093|P|problems (such as HIV-AIDS), frequent vaginal yeast infections||
0678|094|P|(more than 4 per year).||
0678|095|P|   Before having surgery, tell your doctor or dentist about all||
0678|096|P|the products you use (including prescription drugs,||
0678|097|P|nonprescription drugs, and herbal products).||
0678|098|P|   Ask your doctor whether you can have sexual intercourse while||
0678|099|P|using this product. The suppository (but not the cream form) may||
0678|100|P|damage rubber products (such as latex condoms, diaphragms,||
0678|101|P|cervical caps) and lead to failure. This can result in pregnancy.||
0678|102|P|Do not use these products during treatment with the suppository||
0678|103|P|form and for 3 days after treatment is over. Consult your doctor||
0678|104|P|about other forms of barrier protection/birth control (such as||
0678|105|P|polyurethane condoms) during this time or use the cream form of||
0678|106|P|this product.||
0678|107|P|   During pregnancy, this medication should be used only when||
0678|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
0678|109|P|Pregnant women should use extra care when using the vaginal||
0678|110|P|applicator. Follow your doctor's instructions closely on how to||
0678|111|P|insert the medication using the applicator. The manufacturer does||
0678|112|P|not recommend using this product during the first 3 months of||
0678|113|P|pregnancy. Discuss the risks and benefits with your doctor.||
0678|114|P|   It is unknown if this medication passes into breast milk.||
0678|115|P|Consult your doctor before breastfeeding.||
0678|116|B|||
0678|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0678|118|I|medications work or increase your risk for serious side effects.||
0678|119|I|This document does not contain all possible drug interactions.||
0678|120|I|Keep a list of all the products you use (including||
0678|121|I|prescription/nonprescription drugs and herbal products) and share||
0678|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
0678|123|I|the dosage of any medicines without your doctor's approval.||
0678|124|B|||
0678|125|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0678|126|O|has overdosed and has serious symptoms such as passing out or||
0678|127|O|trouble breathing, call 911. Otherwise, call a poison control||
0678|128|O|center right away. US residents can call 1-800-222-1222. Canada||
0678|129|O|residents can call 1-844-764-7669.||
0678|130|B|||
0678|131|N|NOTES:  Do not share this medication with others.||
0678|132|N|   To help prevent vaginal yeast infections, dry the genital area||
0678|133|N|thoroughly after showering, bathing, or swimming. Avoid wearing||
0678|134|N|tight jeans, nylon underwear, pantyhose, a wet bathing suit, or||
0678|135|N|damp/sweaty exercise clothes for long periods. Wear cotton||
0678|136|N|underwear, and change your underwear daily.||
0678|137|N|   This medication has been prescribed for your current condition||
0678|138|N|only. Do not use it later for another infection unless your||
0678|139|N|doctor tells you to.||
0678|140|N|   If your sexual partner experiences symptoms, they should||
0678|141|N|contact their doctor right away.||
0678|142|B|||
0678|143|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0678|144|D|If it is near the time of the next dose, skip the missed dose.||
0678|145|D|Use your next dose at the regular time. Do not double the dose to||
0678|146|D|catch up.||
0678|147|B|||
0678|148|R|STORAGE:  Store the cream or suppository at room temperature.||
0678|149|R|Keep all medications away from children and pets.||
0678|150|R|   Do not flush medications down the toilet or pour them into a||
0678|151|R|drain unless instructed to do so. Properly discard this product||
0678|152|R|when it is expired or no longer needed. Consult your pharmacist||
0678|153|R|or local waste disposal company.||
0678|154|B|||
0678|155|A|Information last revised November 2024.||
0678|156|A|Copyright(c) 2025 First Databank, Inc.||
0678|157|B|||
0679|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0679|002|Z|does NOT have all possible information about this product. This||
0679|003|Z|information does not assure that this product is safe, effective,||
0679|004|Z|or appropriate for you. This information is not individual||
0679|005|Z|medical advice and does not substitute for the advice of your||
0679|006|Z|health care professional. Always ask your health care||
0679|007|Z|professional for complete information about this product and your||
0679|008|Z|specific health needs.||
0679|009|B|||
0679|010|T|NORTRIPTYLINE - ORAL||
0679|011|F|(nor-TRIP-ti-leen)||
0679|012|B|||
0679|013|C|COMMON BRAND NAME(S): Aventyl, Pamelor||
0679|014|B|||
0679|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0679|016|W|of conditions, including depression and other mental/mood||
0679|017|W|disorders. These medications can help prevent suicidal||
0679|018|W|thoughts/attempts and provide other important benefits. However,||
0679|019|W|studies have shown that a small number of people (especially||
0679|020|W|people younger than 25) who take antidepressants for any||
0679|021|W|condition may experience worsening depression, other mental/mood||
0679|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0679|023|W|talk with the doctor about the risks and benefits of||
0679|024|W|antidepressant medication (especially for people younger than||
0679|025|W|25), even if treatment is not for a mental/mood condition. Tell||
0679|026|W|the doctor right away if you notice worsening depression/other||
0679|027|W|psychiatric conditions, unusual behavior changes (including||
0679|028|W|possible suicidal thoughts/attempts), or other mental/mood||
0679|029|W|changes (including new/worsening anxiety, panic attacks, trouble||
0679|030|W|sleeping, irritability, hostile/angry feelings, impulsive||
0679|031|W|actions, severe restlessness, very rapid speech). Be especially||
0679|032|W|watchful for these symptoms when a new antidepressant is started||
0679|033|W|or when the dose is changed.||
0679|034|B|||
0679|035|U|USES:  This medication is used to treat depression. Nortriptyline||
0679|036|U|belongs to a class of drugs known as tricyclic antidepressants.||
0679|037|U|It works by helping to restore the balance of certain natural||
0679|038|U|substances in the brain.||
0679|039|B|||
0679|040|V|OTHER USES:  This section contains uses of this drug that are not||
0679|041|V|listed in the approved professional labeling for the drug but||
0679|042|V|that may be prescribed by your health care professional. Use this||
0679|043|V|drug for a condition that is listed in this section only if it||
0679|044|V|has been so prescribed by your health care professional.||
0679|045|V|   This drug may also be used for nerve pain. It may also be used||
0679|046|V|to help quit smoking.||
0679|047|B|||
0679|048|H|HOW TO USE:  Read the Medication Guide provided by your||
0679|049|H|pharmacist before you start taking nortriptyline and each time||
0679|050|H|you get a refill. If you have any questions, consult your doctor||
0679|051|H|or pharmacist.||
0679|052|H|   Take this medication by mouth as directed by your doctor,||
0679|053|H|usually 1 to 4 times daily. If you are using the liquid form,||
0679|054|H|measure the dose carefully using a special measuring||
0679|055|H|device/spoon. Do not use a household spoon because you may not||
0679|056|H|get the correct dose.||
0679|057|H|   The dosage is based on your medical condition and response to||
0679|058|H|treatment. To reduce your risk of side effects (such as dry||
0679|059|H|mouth, dizziness), your doctor may direct you to start this||
0679|060|H|medication at a low dose and gradually increase your dose. Follow||
0679|061|H|your doctor's instructions carefully.||
0679|062|H|   Take this medication regularly in order to get the most||
0679|063|H|benefit from it. To help you remember, take it at the same||
0679|064|H|time(s) each day. Do not increase your dose or use this drug more||
0679|065|H|often or for longer than prescribed. Your condition will not||
0679|066|H|improve any faster, and your risk of side effects will increase.||
0679|067|H|   Keep taking this medication even if you feel well. Do not stop||
0679|068|H|taking this medication without consulting your doctor. Some||
0679|069|H|conditions may become worse when this drug is suddenly stopped.||
0679|070|H|Also, you may experience symptoms such as mood swings, headache,||
0679|071|H|tiredness, and sleep change. To prevent these symptoms while you||
0679|072|H|are stopping treatment with this drug, your doctor may reduce||
0679|073|H|your dose gradually. Consult your doctor or pharmacist for more||
0679|074|H|details. Report any new or worsening symptoms right away.||
0679|075|H|   This medication may not work right away. You may see some||
0679|076|H|benefit within a week. However, it may take up to 4 weeks before||
0679|077|H|you feel the full effect.||
0679|078|H|   Tell your doctor if your condition lasts or gets worse (such||
0679|079|H|as your feelings of sadness get worse, or you have thoughts of||
0679|080|H|suicide).||
0679|081|B|||
0679|082|S|SIDE EFFECTS:  See also Warning section.||
0679|083|S|   Drowsiness, dizziness, dry mouth, blurred vision,||
0679|084|S|constipation, weight gain, or trouble urinating may occur. If any||
0679|085|S|of these effects last or get worse, notify your doctor or||
0679|086|S|pharmacist promptly.||
0679|087|S|   To reduce the risk of dizziness and lightheadedness, get up||
0679|088|S|slowly when rising from a sitting or lying position.||
0679|089|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0679|090|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0679|091|S|substitute.||
0679|092|S|   To prevent constipation, eat dietary fiber, drink enough||
0679|093|S|water, and exercise. You may also need to take a laxative. Ask||
0679|094|S|your pharmacist which type of laxative is right for you.||
0679|095|S|   Remember that this medication has been prescribed because your||
0679|096|S|doctor has judged that the benefit to you is greater than the||
0679|097|S|risk of side effects. Many people using this medication do not||
0679|098|S|have serious side effects.||
0679|099|S|   Tell your doctor right away if you have any serious side||
0679|100|S|effects, including: heartburn that doesn't go away, shaking,||
0679|101|S|mask-like facial expressions, muscle spasms, severe||
0679|102|S|stomach/abdominal pain, decreased sexual ability/desire,||
0679|103|S|enlarged/painful breasts.||
0679|104|S|   This medication may increase serotonin and rarely cause a very||
0679|105|S|serious condition called serotonin syndrome/toxicity. The risk||
0679|106|S|increases if you are also taking other drugs that increase||
0679|107|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0679|108|S|take (see Drug Interactions section). Get medical help right away||
0679|109|S|if you develop some of the following symptoms: fast heartbeat,||
0679|110|S|hallucinations, loss of coordination, severe dizziness, severe||
0679|111|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0679|112|S|unusual agitation/restlessness.||
0679|113|S|   Get medical help right away if you have any very serious side||
0679|114|S|effects, including: severe dizziness, fast/irregular heartbeat,||
0679|115|S|fainting, seizures, eye pain/swelling/redness, widened pupils,||
0679|116|S|vision changes (such as seeing rainbows around lights at night).||
0679|117|S|   A very serious allergic reaction to this drug is rare.||
0679|118|S|However, get medical help right away if you notice any symptoms||
0679|119|S|of a serious allergic reaction, including: rash, itching/swelling||
0679|120|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0679|121|S|breathing.||
0679|122|S|   This is not a complete list of possible side effects. If you||
0679|123|S|notice other effects not listed above, contact your doctor or||
0679|124|S|pharmacist.||
0679|125|S|   In the US -||
0679|126|S|   Call your doctor for medical advice about side effects. You||
0679|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0679|128|S|www.fda.gov/medwatch.||
0679|129|S|   In Canada - Call your doctor for medical advice about side||
0679|130|S|effects. You may report side effects to Health Canada at||
0679|131|S|1-866-234-2345.||
0679|132|B|||
0679|133|P|PRECAUTIONS:  See also Warning section.||
0679|134|P|   Before taking nortriptyline, tell your doctor or pharmacist if||
0679|135|P|you are allergic to it; or to other tricyclic antidepressants||
0679|136|P|(such as amitriptyline); or if you have any other allergies. This||
0679|137|P|product may contain inactive ingredients, which can cause||
0679|138|P|allergic reactions or other problems. Talk to your pharmacist for||
0679|139|P|more details.||
0679|140|P|   Before using this medication, tell your doctor or pharmacist||
0679|141|P|your medical history, especially of: breathing problems, liver||
0679|142|P|problems, recent heart attack, problems urinating (such as due to||
0679|143|P|enlarged prostate), overactive thyroid (hyperthyroidism),||
0679|144|P|personal or family history of glaucoma (angle-closure type),||
0679|145|P|personal or family history of mental/mood conditions (such as||
0679|146|P|bipolar disorder, psychosis), family history of suicide,||
0679|147|P|seizures, conditions that may increase your risk of seizures||
0679|148|P|(such as other brain disease, alcohol withdrawal).||
0679|149|P|   Nortriptyline may cause a condition that affects the heart||
0679|150|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0679|151|P|serious (rarely fatal) fast/irregular heartbeat and other||
0679|152|P|symptoms (such as severe dizziness, fainting) that need medical||
0679|153|P|attention right away.||
0679|154|P|   The risk of QT prolongation may be increased if you have||
0679|155|P|certain medical conditions or are taking other drugs that may||
0679|156|P|cause QT prolongation. Before using nortriptyline, tell your||
0679|157|P|doctor or pharmacist of all the drugs you take and if you have||
0679|158|P|any of the following conditions: certain heart problems (heart||
0679|159|P|failure, slow heartbeat, Brugada syndrome, QT prolongation in the||
0679|160|P|EKG), family history of certain heart problems (QT prolongation||
0679|161|P|in the EKG, sudden cardiac death).||
0679|162|P|   Low levels of potassium or magnesium in the blood may also||
0679|163|P|increase your risk of QT prolongation. This risk may increase if||
0679|164|P|you use certain drugs (such as diuretics/"water pills") or if you||
0679|165|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0679|166|P|Talk to your doctor about using nortriptyline safely.||
0679|167|P|   This drug may make you dizzy or drowsy or blur your vision.||
0679|168|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0679|169|P|drowsy. Do not drive, use machinery, or do anything that needs||
0679|170|P|alertness or clear vision until you can do it safely. Limit||
0679|171|P|alcoholic beverages. Talk to your doctor if you are using||
0679|172|P|marijuana (cannabis).||
0679|173|P|   Before having surgery, tell your doctor or dentist about all||
0679|174|P|the products you use (including prescription drugs,||
0679|175|P|nonprescription drugs, and herbal products).||
0679|176|P|   This medication may make you more sensitive to the sun. Limit||
0679|177|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0679|178|P|sunscreen and wear protective clothing when outdoors. Tell your||
0679|179|P|doctor right away if you get sunburned or have skin||
0679|180|P|blisters/redness.||
0679|181|P|   The liquid form of this medication may contain alcohol.||
0679|182|P|Caution is advised if you have diabetes, alcohol dependence,||
0679|183|P|liver disease, or any other condition that requires you to||
0679|184|P|limit/avoid alcohol in your diet. Ask your doctor or pharmacist||
0679|185|P|about using this product safely.||
0679|186|P|   If you have diabetes, this drug may make it harder to control||
0679|187|P|your blood sugar levels. Monitor your blood sugar levels||
0679|188|P|regularly and tell your doctor of the results. Your doctor may||
0679|189|P|need to adjust your diabetes medication, exercise program, or||
0679|190|P|diet.||
0679|191|P|   Older adults may be more sensitive to the side effects of this||
0679|192|P|drug, especially dry mouth, dizziness, confusion, difficulty||
0679|193|P|urinating, and QT prolongation (see above).||
0679|194|P|   During pregnancy, this medication should be used only when||
0679|195|P|clearly needed. Since untreated mental/mood problems (such as||
0679|196|P|depression, anxiety, panic disorder) can be a serious condition,||
0679|197|P|do not stop using this medication unless directed by your doctor.||
0679|198|P|If you are planning pregnancy, become pregnant, or think you may||
0679|199|P|be pregnant, immediately discuss with your doctor the benefits||
0679|200|P|and risks of using this medication during pregnancy.||
0679|201|P|   This medication passes into breast milk and may have||
0679|202|P|undesirable effects on a nursing infant. Consult your doctor||
0679|203|P|before breastfeeding.||
0679|204|B|||
0679|205|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0679|206|I|medications work or increase your risk for serious side effects.||
0679|207|I|This document does not contain all possible drug interactions.||
0679|208|I|Keep a list of all the products you use (including||
0679|209|I|prescription/nonprescription drugs and herbal products) and share||
0679|210|I|it with your doctor and pharmacist. Do not start, stop, or change||
0679|211|I|the dosage of any medicines without your doctor's approval.||
0679|212|I|   Some products that may interact with this drug include: "blood||
0679|213|I|thinners" (such as warfarin), disulfiram, thyroid supplements,||
0679|214|I|certain drugs for high blood pressure (drugs that work in the||
0679|215|I|brain such as clonidine, guanabenz).||
0679|216|I|   Taking MAO inhibitors with this medication may cause a serious||
0679|217|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0679|218|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0679|219|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0679|220|I|selegiline, tranylcypromine) during treatment with this||
0679|221|I|medication. Most MAO inhibitors should also not be taken for two||
0679|222|I|weeks before and after treatment with this medication. Ask your||
0679|223|I|doctor when to start or stop taking this medication.||
0679|224|I|   The risk of serotonin syndrome/toxicity increases if you are||
0679|225|I|also taking other drugs that increase serotonin. Examples include||
0679|226|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0679|227|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0679|228|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0679|229|I|serotonin syndrome/toxicity may be more likely when you start or||
0679|230|I|increase the dose of these drugs.||
0679|231|I|   Other medications can affect the removal of nortriptyline from||
0679|232|I|your body, thereby affecting how nortriptyline works. These drugs||
0679|233|I|include cimetidine, drugs to treat irregular heart rate (such as||
0679|234|I|quinidine/propafenone/flecainide). This is not a complete list.||
0679|235|I|   Many drugs besides nortriptyline may affect the heart rhythm||
0679|236|I|(QT prolongation in the EKG), including amiodarone, dofetilide,||
0679|237|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
0679|238|I|(such as erythromycin), among others. Before using nortriptyline,||
0679|239|I|report all medications you are currently using to your doctor or||
0679|240|I|pharmacist.||
0679|241|I|   Tell your doctor or pharmacist if you are taking other||
0679|242|I|products that cause drowsiness, including alcohol, marijuana||
0679|243|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0679|244|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0679|245|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0679|246|I|codeine).||
0679|247|I|   Check the labels on all your medicines (such as allergy or||
0679|248|I|cough-and-cold products) because they may contain ingredients||
0679|249|I|that cause drowsiness. Ask your pharmacist about using those||
0679|250|I|products safely.||
0679|251|I|   Nortriptyline is very similar to amitriptyline. Do not use||
0679|252|I|medications containing amitriptyline while using nortriptyline.||
0679|253|B|||
0679|254|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0679|255|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0679|256|O|poison control center right away. US residents can call||
0679|257|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0679|258|O|Symptoms of overdose may include: extreme drowsiness,||
0679|259|O|hallucinations, fast/irregular heartbeat, fainting, slow/shallow||
0679|260|O|breathing, seizures.||
0679|261|B|||
0679|262|N|NOTES:  Do not share this medication with others.||
0679|263|N|   Lab and/or medical tests (such as EKG, liver function,||
0679|264|N|nortriptyline blood level) may be done while you are taking this||
0679|265|N|medication. Keep all medical and lab appointments. Consult your||
0679|266|N|doctor for more details.||
0679|267|B|||
0679|268|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0679|269|D|remember. If it is near the time of the next dose, skip the||
0679|270|D|missed dose. Take your next dose at the regular time. Do not||
0679|271|D|double the dose to catch up.||
0679|272|B|||
0679|273|R|STORAGE:  Store at room temperature away from light and moisture.||
0679|274|R|Do not store in the bathroom. Keep all medications away from||
0679|275|R|children and pets.||
0679|276|R|   Do not flush medications down the toilet or pour them into a||
0679|277|R|drain unless instructed to do so. Properly discard this product||
0679|278|R|when it is expired or no longer needed. Consult your pharmacist||
0679|279|R|or local waste disposal company.||
0679|280|B|||
0679|281|A|Information last revised May 2024.||
0679|282|A|Copyright(c) 2025 First Databank, Inc.||
0679|283|B|||
0680|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0680|002|Z|does NOT have all possible information about this product. This||
0680|003|Z|information does not assure that this product is safe, effective,||
0680|004|Z|or appropriate for you. This information is not individual||
0680|005|Z|medical advice and does not substitute for the advice of your||
0680|006|Z|health care professional. Always ask your health care||
0680|007|Z|professional for complete information about this product and your||
0680|008|Z|specific health needs.||
0680|009|B|||
0680|010|T|PROTRIPTYLINE - ORAL||
0680|011|F|(pro-TRIP-ti-leen)||
0680|012|B|||
0680|013|C|COMMON BRAND NAME(S): Vivactil||
0680|014|B|||
0680|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0680|016|W|of conditions, including depression and other mental/mood||
0680|017|W|disorders. These medications can help prevent suicidal||
0680|018|W|thoughts/attempts and provide other important benefits. However,||
0680|019|W|studies have shown that a small number of people (especially||
0680|020|W|people younger than 25) who take antidepressants for any||
0680|021|W|condition may experience worsening depression, other mental/mood||
0680|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0680|023|W|talk with the doctor about the risks and benefits of||
0680|024|W|antidepressant medication (especially for people younger than||
0680|025|W|25), even if treatment is not for a mental/mood condition. Tell||
0680|026|W|the doctor right away if you notice worsening depression/other||
0680|027|W|psychiatric conditions, unusual behavior changes (including||
0680|028|W|possible suicidal thoughts/attempts), or other mental/mood||
0680|029|W|changes (including new/worsening anxiety, panic attacks, trouble||
0680|030|W|sleeping, irritability, hostile/angry feelings, impulsive||
0680|031|W|actions, severe restlessness, very rapid speech). Be especially||
0680|032|W|watchful for these symptoms when a new antidepressant is started||
0680|033|W|or when the dose is changed.||
0680|034|B|||
0680|035|U|USES:  This medication is used to treat depression. Protriptyline||
0680|036|U|belongs to a class of drugs known as tricyclic antidepressants.||
0680|037|U|It works by helping to restore the balance of certain natural||
0680|038|U|substances in the brain.||
0680|039|B|||
0680|040|H|HOW TO USE:  Read the Medication Guide provided by your||
0680|041|H|pharmacist before you start taking protriptyline and each time||
0680|042|H|you get a refill. If you have any questions, consult your doctor||
0680|043|H|or pharmacist.||
0680|044|H|   Take this medication by mouth as directed by your doctor,||
0680|045|H|usually 1 to 4 times daily. The dosage is based on your medical||
0680|046|H|condition and response to treatment.||
0680|047|H|   To reduce your risk of side effects (such as dry mouth,||
0680|048|H|anxiety, dizziness), your doctor may direct you to start this||
0680|049|H|medication at a low dose and gradually increase your dose. Follow||
0680|050|H|your doctor's instructions carefully.||
0680|051|H|   Take this medication regularly in order to get the most||
0680|052|H|benefit from it. To help you remember, take it at the same||
0680|053|H|time(s) each day. Do not increase your dose or use this drug more||
0680|054|H|often or for longer than prescribed. Your condition will not||
0680|055|H|improve any faster, and your risk of side effects will increase.||
0680|056|H|   Keep taking this medication even if you feel well. Do not stop||
0680|057|H|taking this medication without consulting your doctor. Some||
0680|058|H|conditions may become worse when this drug is suddenly stopped.||
0680|059|H|Also, you may experience symptoms such as mood swings, headache,||
0680|060|H|tiredness, and sleep change. To prevent these symptoms while you||
0680|061|H|are stopping treatment with this drug, your doctor may reduce||
0680|062|H|your dose gradually. Consult your doctor or pharmacist for more||
0680|063|H|details. Report any new or worsening symptoms right away.||
0680|064|H|   This medication may not work right away. You may see some||
0680|065|H|benefit within a week. However, it may take up to 4 weeks before||
0680|066|H|you feel the full effect.||
0680|067|H|   Tell your doctor if your condition lasts or gets worse (such||
0680|068|H|as your feelings of sadness get worse, or you have thoughts of||
0680|069|H|suicide).||
0680|070|B|||
0680|071|S|SIDE EFFECTS:  See also Warning section.||
0680|072|S|   Drowsiness, dizziness, dry mouth, blurred vision,||
0680|073|S|constipation, weight gain, or trouble urinating may occur. If any||
0680|074|S|of these effects last or get worse, notify your doctor or||
0680|075|S|pharmacist promptly.||
0680|076|S|   To reduce the risk of dizziness and lightheadedness, get up||
0680|077|S|slowly when rising from a sitting or lying position.||
0680|078|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0680|079|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0680|080|S|substitute.||
0680|081|S|   To prevent constipation, eat dietary fiber, drink enough||
0680|082|S|water, and exercise. You may also need to take a laxative. Ask||
0680|083|S|your pharmacist which type of laxative is right for you.||
0680|084|S|   Remember that this medication has been prescribed because your||
0680|085|S|doctor has judged that the benefit to you is greater than the||
0680|086|S|risk of side effects. Many people using this medication do not||
0680|087|S|have serious side effects.||
0680|088|S|   Tell your doctor right away if you have any serious side||
0680|089|S|effects, including: heartburn that doesn't go away, mental/mood||
0680|090|S|changes (such as anxiety, agitation, confusion), shaking,||
0680|091|S|mask-like facial expressions, muscle spasms, severe||
0680|092|S|stomach/abdominal pain, decreased sexual ability/desire,||
0680|093|S|enlarged/painful breasts.||
0680|094|S|   Get medical help right away if you have any very serious side||
0680|095|S|effects, including: slow/fast/irregular heartbeat, seizures, eye||
0680|096|S|pain/swelling/redness, widened pupils, vision changes (such as||
0680|097|S|seeing rainbows around lights at night).||
0680|098|S|   A very serious allergic reaction to this drug is rare.||
0680|099|S|However, get medical help right away if you notice any symptoms||
0680|100|S|of a serious allergic reaction, including: rash, itching/swelling||
0680|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0680|102|S|breathing.||
0680|103|S|   This is not a complete list of possible side effects. If you||
0680|104|S|notice other effects not listed above, contact your doctor or||
0680|105|S|pharmacist.||
0680|106|S|   In the US -||
0680|107|S|   Call your doctor for medical advice about side effects. You||
0680|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0680|109|S|www.fda.gov/medwatch.||
0680|110|S|   In Canada - Call your doctor for medical advice about side||
0680|111|S|effects. You may report side effects to Health Canada at||
0680|112|S|1-866-234-2345.||
0680|113|B|||
0680|114|P|PRECAUTIONS:  See also Warning section.||
0680|115|P|   Before taking protriptyline, tell your doctor or pharmacist if||
0680|116|P|you are allergic to it; or to other tricyclic antidepressants||
0680|117|P|(such as nortriptyline); or if you have any other allergies. This||
0680|118|P|product may contain inactive ingredients, which can cause||
0680|119|P|allergic reactions or other problems. Talk to your pharmacist for||
0680|120|P|more details.||
0680|121|P|   Before using this medication, tell your doctor or pharmacist||
0680|122|P|your medical history, especially of: breathing problems, liver||
0680|123|P|problems, heart problems (such as recent heart attack), problems||
0680|124|P|urinating (such as due to enlarged prostate), overactive thyroid||
0680|125|P|(hyperthyroidism), personal or family history of glaucoma||
0680|126|P|(angle-closure type), personal or family history of mental/mood||
0680|127|P|conditions (such as bipolar disorder, psychosis), family history||
0680|128|P|of suicide, seizures, conditions that may increase your risk of||
0680|129|P|seizures (such as other brain disease, alcohol withdrawal).||
0680|130|P|   This drug may make you dizzy or drowsy or blur your vision.||
0680|131|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0680|132|P|drowsy. Do not drive, use machinery, or do anything that needs||
0680|133|P|alertness or clear vision until you can do it safely. Limit||
0680|134|P|alcoholic beverages. Talk to your doctor if you are using||
0680|135|P|marijuana (cannabis).||
0680|136|P|   Before having surgery, tell your doctor or dentist about all||
0680|137|P|the products you use (including prescription drugs,||
0680|138|P|nonprescription drugs, and herbal products).||
0680|139|P|   This medication may make you more sensitive to the sun. Limit||
0680|140|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0680|141|P|sunscreen and wear protective clothing when outdoors. Tell your||
0680|142|P|doctor right away if you get sunburned or have skin||
0680|143|P|blisters/redness.||
0680|144|P|   If you have diabetes, this drug may make it harder to control||
0680|145|P|your blood sugar levels. Monitor your blood sugar levels||
0680|146|P|regularly and tell your doctor of the results. Your doctor may||
0680|147|P|need to adjust your diabetes medication, exercise program, or||
0680|148|P|diet.||
0680|149|P|   Older adults may be more sensitive to the side effects of this||
0680|150|P|drug, especially dry mouth, dizziness, confusion, and difficulty||
0680|151|P|urinating.||
0680|152|P|   During pregnancy, this medication should be used only when||
0680|153|P|clearly needed. Since untreated mental/mood problems (such as||
0680|154|P|depression) can be a serious condition, do not stop using this||
0680|155|P|medication unless directed by your doctor. If you are planning||
0680|156|P|pregnancy, become pregnant, or think you may be pregnant,||
0680|157|P|immediately discuss with your doctor the benefits and risks of||
0680|158|P|using this medication during pregnancy.||
0680|159|P|   It is unknown if this drug passes into breast milk, but it may||
0680|160|P|have undesirable effects on a nursing infant. Consult your doctor||
0680|161|P|before breastfeeding.||
0680|162|B|||
0680|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0680|164|I|medications work or increase your risk for serious side effects.||
0680|165|I|This document does not contain all possible drug interactions.||
0680|166|I|Keep a list of all the products you use (including||
0680|167|I|prescription/nonprescription drugs and herbal products) and share||
0680|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
0680|169|I|the dosage of any medicines without your doctor's approval.||
0680|170|I|   Some products that may interact with this drug include:||
0680|171|I|thyroid supplements, certain drugs for high blood pressure (drugs||
0680|172|I|that work in the brain such as clonidine, guanabenz).||
0680|173|I|   Taking MAO inhibitors with this medication may cause a serious||
0680|174|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0680|175|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0680|176|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0680|177|I|selegiline, tranylcypromine) during treatment with this||
0680|178|I|medication. Most MAO inhibitors should also not be taken for two||
0680|179|I|weeks before and after treatment with this medication. Ask your||
0680|180|I|doctor when to start or stop taking this medication.||
0680|181|I|   Other medications can affect the removal of protriptyline from||
0680|182|I|your body, thereby affecting how protriptyline works. These drugs||
0680|183|I|include cimetidine, drugs to treat irregular heart rate (such as||
0680|184|I|quinidine/propafenone/flecainide), antidepressants (such as SSRIs||
0680|185|I|including paroxetine/fluoxetine/fluvoxamine). This is not a||
0680|186|I|complete list.||
0680|187|I|   Tell your doctor or pharmacist if you are taking other||
0680|188|I|products that cause drowsiness, including alcohol, marijuana||
0680|189|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0680|190|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0680|191|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0680|192|I|codeine).||
0680|193|I|   Check the labels on all your medicines (such as allergy or||
0680|194|I|cough-and-cold products) because they may contain ingredients||
0680|195|I|that cause drowsiness. Ask your pharmacist about using those||
0680|196|I|products safely.||
0680|197|B|||
0680|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0680|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0680|200|O|poison control center right away. US residents can call||
0680|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0680|202|O|Symptoms of overdose may include: extreme drowsiness,||
0680|203|O|hallucinations, fast/irregular heartbeat, fainting, slow/shallow||
0680|204|O|breathing, seizures.||
0680|205|B|||
0680|206|N|NOTES:  Do not share this medication with others.||
0680|207|N|   Lab and/or medical tests (such as EKG, liver function) may be||
0680|208|N|done while you are taking this medication. Keep all medical and||
0680|209|N|lab appointments. Consult your doctor for more details.||
0680|210|B|||
0680|211|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0680|212|D|remember. If it is near the time of the next dose, skip the||
0680|213|D|missed dose. Take your next dose at the regular time. Do not||
0680|214|D|double the dose to catch up.||
0680|215|B|||
0680|216|R|STORAGE:  Store at room temperature away from light and moisture.||
0680|217|R|Do not store in the bathroom. Keep all medications away from||
0680|218|R|children and pets.||
0680|219|R|   Do not flush medications down the toilet or pour them into a||
0680|220|R|drain unless instructed to do so. Properly discard this product||
0680|221|R|when it is expired or no longer needed. Consult your pharmacist||
0680|222|R|or local waste disposal company.||
0680|223|B|||
0680|224|A|Information last revised May 2024.||
0680|225|A|Copyright(c) 2025 First Databank, Inc.||
0680|226|B|||
0681|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0681|002|Z|does NOT have all possible information about this product. This||
0681|003|Z|information does not assure that this product is safe, effective,||
0681|004|Z|or appropriate for you. This information is not individual||
0681|005|Z|medical advice and does not substitute for the advice of your||
0681|006|Z|health care professional. Always ask your health care||
0681|007|Z|professional for complete information about this product and your||
0681|008|Z|specific health needs.||
0681|009|B|||
0681|010|T|AMITRIPTYLINE - ORAL||
0681|011|F|(AM-i-TRIP-ti-leen)||
0681|012|B|||
0681|013|C|COMMON BRAND NAME(S): Elavil||
0681|014|B|||
0681|015|W|WARNING:  Antidepressant medications are used to treat a variety||
0681|016|W|of conditions, including depression and other mental/mood||
0681|017|W|disorders. These medications can help prevent suicidal||
0681|018|W|thoughts/attempts and provide other important benefits. However,||
0681|019|W|studies have shown that a small number of people (especially||
0681|020|W|people younger than 25) who take antidepressants for any||
0681|021|W|condition may experience worsening depression, other mental/mood||
0681|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0681|023|W|talk with the doctor about the risks and benefits of||
0681|024|W|antidepressant medication (especially for people younger than||
0681|025|W|25), even if treatment is not for a mental/mood condition. Tell||
0681|026|W|the doctor right away if you notice worsening depression/other||
0681|027|W|psychiatric conditions, unusual behavior changes (including||
0681|028|W|possible suicidal thoughts/attempts), or other mental/mood||
0681|029|W|changes (including new/worsening anxiety, panic attacks, trouble||
0681|030|W|sleeping, irritability, hostile/angry feelings, impulsive||
0681|031|W|actions, severe restlessness, very rapid speech). Be especially||
0681|032|W|watchful for these symptoms when a new antidepressant is started||
0681|033|W|or when the dose is changed.||
0681|034|B|||
0681|035|U|USES:  This medication is used to treat depression. Amitriptyline||
0681|036|U|belongs to a class of drugs known as tricyclic antidepressants.||
0681|037|U|It works by helping to restore the balance of certain natural||
0681|038|U|substances in the brain.||
0681|039|B|||
0681|040|V|OTHER USES:  This section contains uses of this drug that are not||
0681|041|V|listed in the approved professional labeling for the drug but||
0681|042|V|that may be prescribed by your health care professional. Use this||
0681|043|V|drug for a condition that is listed in this section only if it||
0681|044|V|has been so prescribed by your health care professional.||
0681|045|V|   This drug may also be used for nerve pain (such as peripheral||
0681|046|V|neuropathy, postherpetic neuralgia), eating disorder (bulimia),||
0681|047|V|or other mental/mood problems (such as anxiety, panic disorder).||
0681|048|V|It may also be used to reduce the risk of migraine headaches.||
0681|049|B|||
0681|050|H|HOW TO USE:  Read the Medication Guide provided by your||
0681|051|H|pharmacist before you start taking amitriptyline and each time||
0681|052|H|you get a refill. If you have any questions, consult your doctor||
0681|053|H|or pharmacist.||
0681|054|H|   Take this medication by mouth as directed by your doctor,||
0681|055|H|usually 1 to 4 times daily. If you take it only once a day, take||
0681|056|H|it at bedtime to help reduce daytime sleepiness. The dosage is||
0681|057|H|based on your medical condition and response to treatment.||
0681|058|H|   To reduce your risk of side effects (such as drowsiness, dry||
0681|059|H|mouth, dizziness), your doctor may direct you to start this||
0681|060|H|medication at a low dose and gradually increase your dose. Follow||
0681|061|H|your doctor's instructions carefully.||
0681|062|H|   Take this medication regularly in order to get the most||
0681|063|H|benefit from it. To help you remember, take it at the same||
0681|064|H|time(s) each day. Do not increase your dose or use this drug more||
0681|065|H|often or for longer than prescribed. Your condition will not||
0681|066|H|improve any faster, and your risk of side effects will increase.||
0681|067|H|   Keep taking this medication even if you feel well. Do not stop||
0681|068|H|taking this medication without consulting your doctor. Some||
0681|069|H|conditions may become worse when this drug is suddenly stopped.||
0681|070|H|Also, you may experience symptoms such as mood swings, headache,||
0681|071|H|tiredness, and sleep change. To prevent these symptoms while you||
0681|072|H|are stopping treatment with this drug, your doctor may reduce||
0681|073|H|your dose gradually. Consult your doctor or pharmacist for more||
0681|074|H|details. Report any new or worsening symptoms right away.||
0681|075|H|   This medication may not work right away. You may see some||
0681|076|H|benefit within a week. However, it may take up to 4 weeks before||
0681|077|H|you feel the full effect.||
0681|078|H|   Tell your doctor if your condition lasts or gets worse (such||
0681|079|H|as your feelings of sadness get worse, or you have thoughts of||
0681|080|H|suicide).||
0681|081|B|||
0681|082|S|SIDE EFFECTS:  See also Warning section.||
0681|083|S|   Drowsiness, dizziness, dry mouth, blurred vision,||
0681|084|S|constipation, weight gain, or trouble urinating may occur. If any||
0681|085|S|of these effects last or get worse, notify your doctor or||
0681|086|S|pharmacist promptly.||
0681|087|S|   To reduce the risk of dizziness and lightheadedness, get up||
0681|088|S|slowly when rising from a sitting or lying position.||
0681|089|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0681|090|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0681|091|S|substitute.||
0681|092|S|   To prevent constipation, eat dietary fiber, drink enough||
0681|093|S|water, and exercise. You may also need to take a laxative. Ask||
0681|094|S|your pharmacist which type of laxative is right for you.||
0681|095|S|   Remember that this medication has been prescribed because your||
0681|096|S|doctor has judged that the benefit to you is greater than the||
0681|097|S|risk of side effects. Many people using this medication do not||
0681|098|S|have serious side effects.||
0681|099|S|   Tell your doctor right away if you have any serious side||
0681|100|S|effects, including: heartburn that doesn't go away, easy||
0681|101|S|bleeding/bruising, shaking, mask-like facial expressions, muscle||
0681|102|S|spasms, severe stomach/abdominal pain, decreased sexual||
0681|103|S|ability/desire, enlarged/painful breasts.||
0681|104|S|   Get medical help right away if you have any very serious side||
0681|105|S|effects, including: black stools, vomit that looks like coffee||
0681|106|S|grounds, fainting, seizures, eye pain/swelling/redness, widened||
0681|107|S|pupils, vision changes (such as seeing rainbows around lights at||
0681|108|S|night).||
0681|109|S|   This medication may increase serotonin and rarely cause a very||
0681|110|S|serious condition called serotonin syndrome/toxicity. The risk||
0681|111|S|increases if you are also taking other drugs that increase||
0681|112|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0681|113|S|take (see Drug Interactions section). Get medical help right away||
0681|114|S|if you develop some of the following symptoms: fast heartbeat,||
0681|115|S|hallucinations, loss of coordination, severe dizziness, severe||
0681|116|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0681|117|S|unusual agitation/restlessness.||
0681|118|S|   This medication may rarely cause a very serious condition||
0681|119|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0681|120|S|right away if you have any of the following symptoms: fever,||
0681|121|S|muscle stiffness, severe confusion, sweating, fast/irregular||
0681|122|S|heartbeat.||
0681|123|S|   A very serious allergic reaction to this drug is rare.||
0681|124|S|However, get medical help right away if you notice any symptoms||
0681|125|S|of a serious allergic reaction, including: rash, itching/swelling||
0681|126|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0681|127|S|breathing.||
0681|128|S|   This is not a complete list of possible side effects. If you||
0681|129|S|notice other effects not listed above, contact your doctor or||
0681|130|S|pharmacist.||
0681|131|S|   In the US -||
0681|132|S|   Call your doctor for medical advice about side effects. You||
0681|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0681|134|S|www.fda.gov/medwatch.||
0681|135|S|   In Canada - Call your doctor for medical advice about side||
0681|136|S|effects. You may report side effects to Health Canada at||
0681|137|S|1-866-234-2345.||
0681|138|B|||
0681|139|P|PRECAUTIONS:  See also Warning section.||
0681|140|P|   Before taking amitriptyline, tell your doctor or pharmacist if||
0681|141|P|you are allergic to it, or to other tricyclic antidepressants||
0681|142|P|(such as nortriptyline), or if you have any other allergies. This||
0681|143|P|product may contain inactive ingredients, which can cause||
0681|144|P|allergic reactions or other problems. Talk to your pharmacist for||
0681|145|P|more details.||
0681|146|P|   Before using this medication, tell your doctor or pharmacist||
0681|147|P|your medical history, especially of: bleeding problems, breathing||
0681|148|P|problems, liver problems, recent heart attack, problems urinating||
0681|149|P|(such as due to enlarged prostate), overactive thyroid||
0681|150|P|(hyperthyroidism), personal or family history of glaucoma||
0681|151|P|(angle-closure type), personal or family history of mental/mood||
0681|152|P|conditions (such as bipolar disorder, psychosis), family history||
0681|153|P|of suicide, seizures, conditions that may increase your risk of||
0681|154|P|seizures (such as other brain disease, alcohol withdrawal).||
0681|155|P|   Amitriptyline may cause a condition that affects the heart||
0681|156|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0681|157|P|serious (rarely fatal) fast/irregular heartbeat and other||
0681|158|P|symptoms (such as severe dizziness, fainting) that need medical||
0681|159|P|attention right away.||
0681|160|P|   The risk of QT prolongation may be increased if you have||
0681|161|P|certain medical conditions or are taking other drugs that may||
0681|162|P|cause QT prolongation. Before using amitriptyline, tell your||
0681|163|P|doctor or pharmacist of all the drugs you take and if you have||
0681|164|P|any of the following conditions: certain heart problems (heart||
0681|165|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0681|166|P|history of certain heart problems (QT prolongation in the EKG,||
0681|167|P|sudden cardiac death).||
0681|168|P|   Low levels of potassium or magnesium in the blood may also||
0681|169|P|increase your risk of QT prolongation. This risk may increase if||
0681|170|P|you use certain drugs (such as diuretics/"water pills") or if you||
0681|171|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0681|172|P|Talk to your doctor about using amitriptyline safely.||
0681|173|P|   This drug may make you dizzy or drowsy or blur your vision.||
0681|174|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0681|175|P|drowsy. Do not drive, use machinery, or do anything that needs||
0681|176|P|alertness or clear vision until you can do it safely. Avoid||
0681|177|P|alcoholic beverages. Talk to your doctor if you are using||
0681|178|P|marijuana (cannabis).||
0681|179|P|   Before having surgery, tell your doctor or dentist about all||
0681|180|P|the products you use (including prescription drugs,||
0681|181|P|nonprescription drugs, and herbal products).||
0681|182|P|   This medication may make you more sensitive to the sun. Limit||
0681|183|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0681|184|P|sunscreen and wear protective clothing when outdoors. Tell your||
0681|185|P|doctor right away if you get sunburned or have skin||
0681|186|P|blisters/redness.||
0681|187|P|   If you have diabetes, this drug may make it harder to control||
0681|188|P|your blood sugar levels. Monitor your blood sugar levels||
0681|189|P|regularly and tell your doctor of the results. Your doctor may||
0681|190|P|need to adjust your diabetes medication, exercise program, or||
0681|191|P|diet.||
0681|192|P|   Older adults may be more sensitive to the side effects of this||
0681|193|P|drug, especially bleeding, dry mouth, dizziness, drowsiness,||
0681|194|P|confusion, constipation, difficulty urinating, and QT||
0681|195|P|prolongation (see above). Dizziness, drowsiness, and confusion||
0681|196|P|can increase the risk of falling. Older adults may also be more||
0681|197|P|likely to develop low sodium in the blood, especially if they are||
0681|198|P|taking "water pills" (diuretics).||
0681|199|P|   During pregnancy, this medication should be used only when||
0681|200|P|clearly needed. Discuss the risks and benefits with your doctor.||
0681|201|P|   Since untreated mental/mood problems (such as depression,||
0681|202|P|anxiety, panic disorder) can be a serious condition, do not stop||
0681|203|P|using this medication unless directed by your doctor. If you are||
0681|204|P|planning pregnancy, become pregnant, or think you may be||
0681|205|P|pregnant, immediately discuss with your doctor the benefits and||
0681|206|P|risks of using this medication during pregnancy.||
0681|207|P|   This medication passes into breast milk and the effect on a||
0681|208|P|nursing infant is unknown. Consult your doctor before||
0681|209|P|breastfeeding.||
0681|210|B|||
0681|211|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0681|212|I|medications work or increase your risk for serious side effects.||
0681|213|I|This document does not contain all possible drug interactions.||
0681|214|I|Keep a list of all the products you use (including||
0681|215|I|prescription/nonprescription drugs and herbal products) and share||
0681|216|I|it with your doctor and pharmacist. Do not start, stop, or change||
0681|217|I|the dosage of any medicines without your doctor's approval.||
0681|218|I|   Some products that may interact with this drug are:||
0681|219|I|disulfiram, thyroid supplements, other drugs that can cause||
0681|220|I|bleeding/bruising (including antiplatelet drugs such as||
0681|221|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
0681|222|I|such as dabigatran/warfarin), certain drugs for high blood||
0681|223|I|pressure (drugs that work in the brain such as clonidine,||
0681|224|I|guanabenz).||
0681|225|I|   Taking MAO inhibitors with this medication may cause a serious||
0681|226|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0681|227|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0681|228|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0681|229|I|selegiline, tranylcypromine) during treatment with this||
0681|230|I|medication. Most MAO inhibitors should also not be taken for two||
0681|231|I|weeks before and after treatment with this medication. Ask your||
0681|232|I|doctor when to start or stop taking this medication.||
0681|233|I|   The risk of serotonin syndrome/toxicity increases if you are||
0681|234|I|also taking other drugs that increase serotonin. Examples include||
0681|235|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
0681|236|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0681|237|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0681|238|I|serotonin syndrome/toxicity may be more likely when you start or||
0681|239|I|increase the dose of these drugs.||
0681|240|I|   Other medications can affect the removal of amitriptyline from||
0681|241|I|your body, thereby affecting how amitriptyline works. These drugs||
0681|242|I|include cimetidine, drugs to treat irregular heart rate (such as||
0681|243|I|quinidine/propafenone/flecainide), among others.||
0681|244|I|   Many drugs besides amitriptyline may affect the heart rhythm||
0681|245|I|(QT prolongation in the EKG), including amiodarone, dofetilide,||
0681|246|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
0681|247|I|(such as erythromycin), among others. Before using amitriptyline,||
0681|248|I|report all medications you are currently using to your doctor or||
0681|249|I|pharmacist.||
0681|250|I|   Tell your doctor or pharmacist if you are taking other||
0681|251|I|products that cause drowsiness, including alcohol, marijuana||
0681|252|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0681|253|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0681|254|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0681|255|I|codeine).||
0681|256|I|   Check the labels on all your medicines (such as allergy or||
0681|257|I|cough-and-cold products) because they may contain ingredients||
0681|258|I|that cause drowsiness. Ask your pharmacist about using those||
0681|259|I|products safely.||
0681|260|I|   Aspirin can increase the risk of bleeding when used with this||
0681|261|I|medication. However, if your doctor has told you to take low-dose||
0681|262|I|aspirin to prevent heart attack or stroke (usually 81-162||
0681|263|I|milligrams a day), you should keep taking the aspirin unless your||
0681|264|I|doctor tells you not to. Ask your doctor or pharmacist for more||
0681|265|I|details.||
0681|266|I|   Amitriptyline is very similar to nortriptyline. Do not use||
0681|267|I|medications containing nortriptyline while using amitriptyline.||
0681|268|B|||
0681|269|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0681|270|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0681|271|O|poison control center right away. US residents can call||
0681|272|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0681|273|O|Symptoms of overdose may include: extreme drowsiness,||
0681|274|O|hallucinations, fast/irregular heartbeat, fainting, slow/shallow||
0681|275|O|breathing, seizures.||
0681|276|B|||
0681|277|N|NOTES:  Do not share this medication with others.||
0681|278|N|   Lab and/or medical tests (such as EKG, liver function,||
0681|279|N|amitriptyline blood level) may be done while you are taking this||
0681|280|N|medication. Keep all medical and lab appointments. Consult your||
0681|281|N|doctor for more details.||
0681|282|B|||
0681|283|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0681|284|D|remember. If it is near the time of the next dose, skip the||
0681|285|D|missed dose. Take your next dose at the regular time. Do not||
0681|286|D|double the dose to catch up.||
0681|287|B|||
0681|288|R|STORAGE:  Store at room temperature away from light and moisture.||
0681|289|R|Do not store in the bathroom. Keep all medications away from||
0681|290|R|children and pets.||
0681|291|R|   Do not flush medications down the toilet or pour them into a||
0681|292|R|drain unless instructed to do so. Properly discard this product||
0681|293|R|when it is expired or no longer needed. Consult your pharmacist||
0681|294|R|or local waste disposal company.||
0681|295|B|||
0681|296|A|Information last revised July 2025.||
0681|297|A|Copyright(c) 2025 First Databank, Inc.||
0681|298|B|||
0683|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0683|002|Z|does NOT have all possible information about this product. This||
0683|003|Z|information does not assure that this product is safe, effective,||
0683|004|Z|or appropriate for you. This information is not individual||
0683|005|Z|medical advice and does not substitute for the advice of your||
0683|006|Z|health care professional. Always ask your health care||
0683|007|Z|professional for complete information about this product and your||
0683|008|Z|specific health needs.||
0683|009|B|||
0683|010|T|CHLOROTHIAZIDE - ORAL||
0683|011|F|(KLOR-oh-THYE-a-zide)||
0683|012|B|||
0683|013|C|COMMON BRAND NAME(S): Diuril||
0683|014|B|||
0683|015|U|USES:  This medication is used to treat high blood pressure.||
0683|016|U|Lowering high blood pressure helps prevent strokes, heart||
0683|017|U|attacks, and kidney problems. Chlorothiazide is a "water pill"||
0683|018|U|(diuretic) that causes you to make more urine. This helps your||
0683|019|U|body get rid of extra salt and water.||
0683|020|U|   This medication is also used to decrease swelling (edema)||
0683|021|U|caused by conditions such as cancer, heart failure, liver||
0683|022|U|disease, and kidney disease. This effect can help your kidneys||
0683|023|U|work better and lessen symptoms such as trouble breathing and||
0683|024|U|swelling in your ankles, feet, hands, or belly.||
0683|025|B|||
0683|026|V|OTHER USES:  This section contains uses of this drug that are not||
0683|027|V|listed in the approved professional labeling for the drug but||
0683|028|V|that may be prescribed by your health care professional. Use this||
0683|029|V|drug for a condition that is listed in this section only if it||
0683|030|V|has been so prescribed by your health care professional.||
0683|031|V|   This drug may also be used for a condition known as "water||
0683|032|V|diabetes" (diabetes insipidus). It may also be used to reduce the||
0683|033|V|risk of calcium kidney stones.||
0683|034|B|||
0683|035|H|HOW TO USE:  Take this medication by mouth with or without food||
0683|036|H|as directed by your doctor, usually once or twice a day. If you||
0683|037|H|take this drug too close to bedtime, you may need to wake up to||
0683|038|H|urinate. It is best to take this medication at least 4 hours||
0683|039|H|before your bedtime.||
0683|040|H|   If you are using the liquid form of this medication, carefully||
0683|041|H|measure the dose using a special measuring device/spoon. Do not||
0683|042|H|use a household spoon because you may not get the correct dose.||
0683|043|H|Shake the bottle well before each dose.||
0683|044|H|   The dosage is based on your medical condition and response to||
0683|045|H|treatment. Children's dosage is also based on age and weight.||
0683|046|H|   Use this medication regularly to get the most benefit from it.||
0683|047|H|To help you remember, take it at the same time(s) each day. Keep||
0683|048|H|taking this medication even if you feel well. Most people with||
0683|049|H|high blood pressure do not feel sick.||
0683|050|H|   Cholestyramine and colestipol can decrease the absorption of||
0683|051|H|chlorothiazide. If you are taking either of these drugs, take||
0683|052|H|them at least 4 hours before or after taking chlorothiazide.||
0683|053|H|   Tell your doctor if your condition does not get better or if||
0683|054|H|it gets worse (for example, your blood pressure readings remain||
0683|055|H|high or increase).||
0683|056|B|||
0683|057|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, blurred||
0683|058|S|vision, loss of appetite, stomach upset, diarrhea, or||
0683|059|S|constipation may occur as your body adjusts to the medication.||
0683|060|S|You may also experience decreased sexual ability. If any of these||
0683|061|S|effects last or get worse, tell your doctor or pharmacist||
0683|062|S|promptly.||
0683|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
0683|064|S|slowly when rising from a sitting or lying position.||
0683|065|S|   Remember that this medication has been prescribed because your||
0683|066|S|doctor has judged that the benefit to you is greater than the||
0683|067|S|risk of side effects. Many people using this medication do not||
0683|068|S|have serious side effects.||
0683|069|S|   This medication can cause dehydration and electrolyte||
0683|070|S|imbalance. Tell your doctor right away if you have any symptoms||
0683|071|S|of dehydration or electrolyte imbalance, including unusual dry||
0683|072|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0683|073|S|heartbeat, or confusion.||
0683|074|S|   Tell your doctor right away if you have any serious side||
0683|075|S|effects, including: signs of liver problems (such as||
0683|076|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
0683|077|S|yellowing eyes/skin, dark urine), fainting, joint pain (such as||
0683|078|S|big toe pain), numbness/tingling of the arms/legs, easy||
0683|079|S|bruising/bleeding, unusual tiredness, signs of kidney problems||
0683|080|S|(such as change in the amount of urine).||
0683|081|S|   Get medical help right away if you have any very serious side||
0683|082|S|effects, including: decrease in vision, eye pain.||
0683|083|S|   A very serious allergic reaction to this drug is rare.||
0683|084|S|However, get medical help right away if you notice any symptoms||
0683|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0683|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0683|087|S|breathing.||
0683|088|S|   This is not a complete list of possible side effects. If you||
0683|089|S|notice other effects not listed above, contact your doctor or||
0683|090|S|pharmacist.||
0683|091|S|   In the US -||
0683|092|S|   Call your doctor for medical advice about side effects. You||
0683|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0683|094|S|www.fda.gov/medwatch.||
0683|095|S|   In Canada - Call your doctor for medical advice about side||
0683|096|S|effects. You may report side effects to Health Canada at||
0683|097|S|1-866-234-2345.||
0683|098|B|||
0683|099|P|PRECAUTIONS:  Before taking chlorothiazide, tell your doctor or||
0683|100|P|pharmacist if you are allergic to it; or if you have any other||
0683|101|P|allergies. This product may contain inactive ingredients, which||
0683|102|P|can cause allergic reactions or other problems. Talk to your||
0683|103|P|pharmacist for more details.||
0683|104|P|   Before using this medication, tell your doctor or pharmacist||
0683|105|P|your medical history, especially of: kidney disease, liver||
0683|106|P|disease, untreated salt/mineral imbalance (such as imbalance of||
0683|107|P|sodium, potassium, calcium, magnesium), dehydration, gout, lupus,||
0683|108|P|certain recent nerve surgery (sympathectomy).||
0683|109|P|   If you have diabetes, chlorothiazide may affect your blood||
0683|110|P|sugar. Check your blood sugar regularly as directed and share the||
0683|111|P|results with your doctor. Tell your doctor right away if you have||
0683|112|P|symptoms of high blood sugar such as increased thirst/urination.||
0683|113|P|Your doctor may need to adjust your diabetes medication, exercise||
0683|114|P|program, or diet.||
0683|115|P|   This drug may make you dizzy or blur your vision. Alcohol or||
0683|116|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
0683|117|P|machinery, or do anything that needs alertness or clear vision||
0683|118|P|until you can do it safely. Limit alcoholic beverages. Talk to||
0683|119|P|your doctor if you are using marijuana (cannabis).||
0683|120|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0683|121|P|and cause you to feel lightheaded. Tell your doctor if you have||
0683|122|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0683|123|P|of fluids unless your doctor tells you not to.||
0683|124|P|   This drug may decrease your potassium levels. Ask your doctor||
0683|125|P|about foods high in potassium (such as bananas, orange juice) or||
0683|126|P|about using a salt substitute containing potassium. A potassium||
0683|127|P|supplement may be prescribed by your doctor.||
0683|128|P|   This medication may make you more sensitive to the sun. Limit||
0683|129|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0683|130|P|sunscreen and wear protective clothing when outdoors. Tell your||
0683|131|P|doctor right away if you get sunburned or have skin||
0683|132|P|blisters/redness.||
0683|133|P|   Before having surgery, tell your doctor or dentist about all||
0683|134|P|the products you use (such as prescription drugs, nonprescription||
0683|135|P|drugs, and herbal products).||
0683|136|P|   Older adults may be more sensitive to the side effects of this||
0683|137|P|drug, especially dizziness.||
0683|138|P|   During pregnancy, this medication should be used only when||
0683|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
0683|140|P|   This drug passes into breast milk. Consult your doctor before||
0683|141|P|breastfeeding.||
0683|142|B|||
0683|143|I|DRUG INTERACTIONS:  See also How to Use section.||
0683|144|I|   Drug interactions may change how your medications work or||
0683|145|I|increase your risk for serious side effects. This document does||
0683|146|I|not contain all possible drug interactions. Keep a list of all||
0683|147|I|the products you use (such as prescription/nonprescription drugs||
0683|148|I|and herbal products) and share it with your doctor and||
0683|149|I|pharmacist. Do not start, stop, or change the dosage of any||
0683|150|I|medicines without your doctor's approval.||
0683|151|I|   Some products that may interact with this drug are:||
0683|152|I|dofetilide, lithium.||
0683|153|I|   Some products have ingredients that could raise your blood||
0683|154|I|pressure or worsen your swelling. Tell your pharmacist what||
0683|155|I|products you are using, and ask how to use them safely||
0683|156|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0683|157|I|ibuprofen/naproxen).||
0683|158|I|   This product may interfere with certain lab tests. Make sure||
0683|159|I|lab personnel and all your doctors know you use this drug.||
0683|160|B|||
0683|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0683|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0683|163|O|poison control center right away. US residents can call||
0683|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0683|165|O|Symptoms of overdose may include: severe dizziness, severe||
0683|166|O|weakness, fainting.||
0683|167|B|||
0683|168|N|NOTES:  Do not share this medication with others.||
0683|169|N|   Lifestyle changes that may help this medication work better||
0683|170|N|include exercising, stopping smoking, and eating a||
0683|171|N|low-cholesterol/low-fat diet. Consult your doctor for more||
0683|172|N|details.||
0683|173|N|   Lab and/or medical tests (such as potassium levels, kidney||
0683|174|N|function) may be done while you are taking this medication. Keep||
0683|175|N|all medical and lab appointments. Consult your doctor for more||
0683|176|N|details.||
0683|177|N|   Have your blood pressure checked regularly while taking this||
0683|178|N|medication. Learn how to monitor your own blood pressure at home,||
0683|179|N|and share the results with your doctor.||
0683|180|B|||
0683|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0683|182|D|remember. If it is near the time of the next dose, skip the||
0683|183|D|missed dose. Take your next dose at the regular time. Do not||
0683|184|D|double the dose to catch up.||
0683|185|B|||
0683|186|R|STORAGE:  Store at room temperature away from light and moisture.||
0683|187|R|Do not store in the bathroom. Do not freeze the liquid form of||
0683|188|R|this medication. Keep all medications away from children and||
0683|189|R|pets.||
0683|190|R|   Do not flush medications down the toilet or pour them into a||
0683|191|R|drain unless instructed to do so. Properly discard this product||
0683|192|R|when it is expired or no longer needed. Consult your pharmacist||
0683|193|R|or local waste disposal company.||
0683|194|B|||
0683|195|A|Information last revised April 2025.||
0683|196|A|Copyright(c) 2025 First Databank, Inc.||
0683|197|B|||
0684|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0684|002|Z|does NOT have all possible information about this product. This||
0684|003|Z|information does not assure that this product is safe, effective,||
0684|004|Z|or appropriate for you. This information is not individual||
0684|005|Z|medical advice and does not substitute for the advice of your||
0684|006|Z|health care professional. Always ask your health care||
0684|007|Z|professional for complete information about this product and your||
0684|008|Z|specific health needs.||
0684|009|B|||
0684|010|T|CHLORTHALIDONE - ORAL||
0684|011|F|(klor-THAL-i-done)||
0684|012|B|||
0684|013|C|COMMON BRAND NAME(S): Hemiclor, Thalitone||
0684|014|B|||
0684|015|U|USES:  Chlorthalidone is used to treat high blood pressure||
0684|016|U|(hypertension). Lowering high blood pressure helps prevent||
0684|017|U|strokes, heart attacks, and kidney problems. It is also used to||
0684|018|U|reduce extra salt and water in the body caused by conditions such||
0684|019|U|as heart failure, liver disease, and kidney disease. Decreasing||
0684|020|U|extra salt and water in the body helps to decrease swelling||
0684|021|U|(edema) and breathing problems caused by fluid in the lungs.||
0684|022|U|Chlorthalidone is a "water pill" (diuretic). It increases the||
0684|023|U|amount of urine you make, especially when you first start the||
0684|024|U|medication. It also helps to relax the blood vessels so that||
0684|025|U|blood can flow more easily.||
0684|026|B|||
0684|027|V|OTHER USES:  This section contains uses of this drug that are not||
0684|028|V|listed in the approved professional labeling for the drug but||
0684|029|V|that may be prescribed by your health care professional. Use this||
0684|030|V|drug for a condition that is listed in this section only if it||
0684|031|V|has been so prescribed by your health care professional.||
0684|032|V|   This drug may also be used for a condition known as "water||
0684|033|V|diabetes" (diabetes insipidus). It may also be used to reduce the||
0684|034|V|risk of calcium kidney stones in people with increased calcium in||
0684|035|V|their urine (hypercalciuria).||
0684|036|B|||
0684|037|H|HOW TO USE:  Take this medication by mouth with food as directed||
0684|038|H|by your doctor, usually once daily in the morning. It is best to||
0684|039|H|avoid taking this medication within 4 hours of your bedtime to||
0684|040|H|avoid having to get up to urinate. Consult your doctor or||
0684|041|H|pharmacist if you have questions about your dosing schedule.||
0684|042|H|   The dosage is based on your medical condition and response to||
0684|043|H|treatment.||
0684|044|H|   Use this medication regularly to get the most benefit from it.||
0684|045|H|To help you remember, take it at the same time each day. Keep||
0684|046|H|taking this medication even if you feel well. Most people with||
0684|047|H|high blood pressure do not feel sick.||
0684|048|H|   If you also take certain drugs to lower your cholesterol (bile||
0684|049|H|acid-binding resins such as cholestyramine or colestipol), take||
0684|050|H|this product at least 2 hours before or at least 4 hours after||
0684|051|H|these medications.||
0684|052|H|   Tell your doctor if your condition does not get better or if||
0684|053|H|it gets worse (for example, your blood pressure readings remain||
0684|054|H|high or increase).||
0684|055|B|||
0684|056|S|SIDE EFFECTS:  Dizziness, lightheadedness, or stomach upset may||
0684|057|S|occur. If any of these effects last or get worse, tell your||
0684|058|S|doctor or pharmacist promptly.||
0684|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
0684|060|S|slowly when rising from a sitting or lying position.||
0684|061|S|   Remember that this medication has been prescribed because your||
0684|062|S|doctor has judged that the benefit to you is greater than the||
0684|063|S|risk of side effects. Many people using this medication do not||
0684|064|S|have serious side effects.||
0684|065|S|   This medication may cause dehydration and electrolyte||
0684|066|S|imbalance. Tell your doctor right away if you have any symptoms||
0684|067|S|of dehydration or electrolyte imbalance, including unusual dry||
0684|068|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0684|069|S|heartbeat, or confusion.||
0684|070|S|   Tell your doctor right away if you have any serious side||
0684|071|S|effects, including: fainting, toe/joint pain, signs of kidney||
0684|072|S|problems (such as change in the amount of urine).||
0684|073|S|   Get medical help right away if you have any very serious side||
0684|074|S|effects, including: decrease in vision, eye pain.||
0684|075|S|   A very serious allergic reaction to this drug is rare.||
0684|076|S|However, get medical help right away if you notice any symptoms||
0684|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0684|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0684|079|S|breathing.||
0684|080|S|   This is not a complete list of possible side effects. If you||
0684|081|S|notice other effects not listed above, contact your doctor or||
0684|082|S|pharmacist.||
0684|083|S|   In the US -||
0684|084|S|   Call your doctor for medical advice about side effects. You||
0684|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0684|086|S|www.fda.gov/medwatch.||
0684|087|S|   In Canada - Call your doctor for medical advice about side||
0684|088|S|effects. You may report side effects to Health Canada at||
0684|089|S|1-866-234-2345.||
0684|090|B|||
0684|091|P|PRECAUTIONS:  Before taking chlorthalidone, tell your doctor or||
0684|092|P|pharmacist if you are allergic to it; or if you have any other||
0684|093|P|allergies. This product may contain inactive ingredients, which||
0684|094|P|can cause allergic reactions or other problems. Talk to your||
0684|095|P|pharmacist for more details.||
0684|096|P|   Before using this medication, tell your doctor or pharmacist||
0684|097|P|your medical history, especially of: kidney disease, liver||
0684|098|P|disease, gout, lupus, untreated mineral imbalance (such as low||
0684|099|P|potassium).||
0684|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0684|101|P|can make you more dizzy. Do not drive, use machinery, or do||
0684|102|P|anything that needs alertness until you can do it safely. Limit||
0684|103|P|alcoholic beverages. Talk to your doctor if you are using||
0684|104|P|marijuana (cannabis).||
0684|105|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0684|106|P|and cause you to feel lightheaded. Tell your doctor if you have||
0684|107|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0684|108|P|of fluids unless your doctor tells you not to.||
0684|109|P|   Before having surgery, tell your doctor or dentist about all||
0684|110|P|the products you use (including prescription drugs,||
0684|111|P|nonprescription drugs, and herbal products).||
0684|112|P|   If you have diabetes, this product may affect your blood||
0684|113|P|sugar. Check your blood sugar regularly as directed and share the||
0684|114|P|results with your doctor. Tell your doctor right away if you have||
0684|115|P|symptoms of high blood sugar such as increased thirst/urination.||
0684|116|P|Your doctor may need to adjust your diabetes medication, exercise||
0684|117|P|program, or diet.||
0684|118|P|   This medication may reduce the potassium levels in your blood.||
0684|119|P|Ask your doctor about adding potassium to your diet. A potassium||
0684|120|P|supplement may be prescribed by your doctor.||
0684|121|P|   This medication may make you more sensitive to the sun. Limit||
0684|122|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0684|123|P|sunscreen and wear protective clothing when outdoors. Tell your||
0684|124|P|doctor right away if you get sunburned or have skin||
0684|125|P|blisters/redness.||
0684|126|P|   Older adults may be more sensitive to the side effects of this||
0684|127|P|product, especially dizziness.||
0684|128|P|   During pregnancy, this medication should be used only when||
0684|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
0684|130|P|   This medication passes into breast milk. Consult your doctor||
0684|131|P|before breastfeeding.||
0684|132|B|||
0684|133|I|DRUG INTERACTIONS:  See also How to Use section.||
0684|134|I|   Drug interactions may change how your medications work or||
0684|135|I|increase your risk for serious side effects. This document does||
0684|136|I|not contain all possible drug interactions. Keep a list of all||
0684|137|I|the products you use (including prescription/nonprescription||
0684|138|I|drugs and herbal products) and share it with your doctor and||
0684|139|I|pharmacist. Do not start, stop, or change the dosage of any||
0684|140|I|medicines without your doctor's approval.||
0684|141|I|   Some products that may interact with this drug include:||
0684|142|I|dofetilide, lithium.||
0684|143|I|   Some products have ingredients that could raise your blood||
0684|144|I|pressure or worsen your heart failure. Tell your pharmacist what||
0684|145|I|products you are using, and ask how to use them safely||
0684|146|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
0684|147|I|ibuprofen/naproxen).||
0684|148|I|   This medication may interfere with certain lab tests (such as||
0684|149|I|parathyroid test, protein-bound iodide test), possibly causing||
0684|150|I|false test results. Make sure lab personnel and all your doctors||
0684|151|I|know you use this drug.||
0684|152|B|||
0684|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0684|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0684|155|O|poison control center right away. US residents can call||
0684|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0684|157|O|Symptoms of overdose may include: severe dizziness, fainting.||
0684|158|B|||
0684|159|N|NOTES:  Do not share this medication with others.||
0684|160|N|   Lifestyle changes that may help this medication work better||
0684|161|N|include stress reduction programs, exercise, and dietary changes.||
0684|162|N|Talk to your doctor or pharmacist about lifestyle changes that||
0684|163|N|might benefit you.||
0684|164|N|   Lab and/or medical tests (including kidney function, blood||
0684|165|N|mineral levels such as potassium) should be done while you are||
0684|166|N|taking this medication. Keep all medical and lab appointments.||
0684|167|N|Consult your doctor for more details.||
0684|168|N|   Check your blood pressure regularly while taking this||
0684|169|N|medication. Learn how to monitor your own blood pressure at home,||
0684|170|N|and share the results with your doctor.||
0684|171|B|||
0684|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0684|173|D|remember. If it is near the time of the next dose, skip the||
0684|174|D|missed dose. Take your next dose at the regular time. Do not||
0684|175|D|double the dose to catch up.||
0684|176|B|||
0684|177|R|STORAGE:  Store at room temperature away from light and moisture.||
0684|178|R|Do not store in the bathroom. Keep all medications away from||
0684|179|R|children and pets.||
0684|180|R|   Do not flush medications down the toilet or pour them into a||
0684|181|R|drain unless instructed to do so. Properly discard this product||
0684|182|R|when it is expired or no longer needed. Consult your pharmacist||
0684|183|R|or local waste disposal company.||
0684|184|B|||
0684|185|A|Information last revised May 2024.||
0684|186|A|Copyright(c) 2025 First Databank, Inc.||
0684|187|B|||
0685|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0685|002|Z|does NOT have all possible information about this product. This||
0685|003|Z|information does not assure that this product is safe, effective,||
0685|004|Z|or appropriate for you. This information is not individual||
0685|005|Z|medical advice and does not substitute for the advice of your||
0685|006|Z|health care professional. Always ask your health care||
0685|007|Z|professional for complete information about this product and your||
0685|008|Z|specific health needs.||
0685|009|B|||
0685|010|T|TRIHEXYPHENIDYL - ORAL||
0685|011|F|(try-hex-ee-FEH-nih-dill)||
0685|012|B|||
0685|013|C|COMMON BRAND NAME(S): Artane||
0685|014|B|||
0685|015|U|USES:  Trihexyphenidyl is used to treat symptoms of Parkinson's||
0685|016|U|disease or involuntary movements due to the side effects of||
0685|017|U|certain psychiatric drugs (antipsychotics such as||
0685|018|U|chlorpromazine/haloperidol). Trihexyphenidyl belongs to a class||
0685|019|U|of medication called anticholinergics that work by blocking a||
0685|020|U|certain natural substance (acetylcholine). This helps decrease||
0685|021|U|muscle stiffness, sweating, and the production of saliva, and||
0685|022|U|helps improve walking ability in people with Parkinson's disease.||
0685|023|U|   Anticholinergics can stop severe muscle spasms of the back,||
0685|024|U|neck, and eyes that are sometimes caused by psychiatric drugs. It||
0685|025|U|can also decrease other side effects such as muscle||
0685|026|U|stiffness/rigidity (extrapyramidal signs-EPS). It is not helpful||
0685|027|U|in treating movement problems caused by tardive dyskinesia and||
0685|028|U|may worsen them.||
0685|029|B|||
0685|030|H|HOW TO USE:  Take this medication by mouth as directed by your||
0685|031|H|doctor, usually 3 to 4 times a day with meals and at bedtime.||
0685|032|H|Your doctor may start you at a low dose and increase your dose||
0685|033|H|slowly to find the best dose for you. The dosage is based on your||
0685|034|H|medical condition, age, and response to treatment.||
0685|035|H|   If you are using the liquid form of this medication, measure||
0685|036|H|your dose with a special measuring spoon or device. Do not use a||
0685|037|H|household spoon because it may not provide the correct dose.||
0685|038|H|   Take this medication regularly in order to get the most||
0685|039|H|benefit from it. To help you remember, take it at the same times||
0685|040|H|each day.||
0685|041|H|   Take this medication at least 1 hour before antacids||
0685|042|H|containing magnesium, aluminum, or calcium. Allow at least 1-2||
0685|043|H|hours between doses of trihexyphenidyl and certain drugs for||
0685|044|H|diarrhea (adsorbent antidiarrheals such as kaolin, pectin,||
0685|045|H|attapulgite). Take this medication at least 2 hours after||
0685|046|H|ketoconazole. Antacids and some drugs for diarrhea may prevent||
0685|047|H|the full absorption of trihexyphenidyl, and this product may||
0685|048|H|prevent the complete absorption of ketoconazole when these||
0685|049|H|products are taken together.||
0685|050|H|   If you are taking this medication for side effects from||
0685|051|H|another medication, your doctor may instruct you to take it on a||
0685|052|H|regular schedule or only as needed. If you are taking this||
0685|053|H|medication for Parkinson's disease, your doctor may change the||
0685|054|H|dose of your other medications (such as levodopa). Follow your||
0685|055|H|doctor's instructions closely.||
0685|056|H|   Though it helps many people, this medication may sometimes||
0685|057|H|cause addiction. This risk may be higher if you have a substance||
0685|058|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0685|059|H|Do not increase your dose, take it more often, or use it for a||
0685|060|H|longer time than prescribed. Properly stop the medication when so||
0685|061|H|directed. Some conditions may become worse when the drug is||
0685|062|H|suddenly stopped. Your dose may need to be gradually decreased.||
0685|063|H|   When used for an extended period, this medication may not work||
0685|064|H|as well and may require different dosing. Talk with your doctor||
0685|065|H|if this medication stops working well. Tell your doctor if your||
0685|066|H|condition lasts or gets worse.||
0685|067|B|||
0685|068|S|SIDE EFFECTS:  Drowsiness, dizziness, constipation, flushing,||
0685|069|S|nausea, nervousness, blurred vision, or dry mouth may occur.||
0685|070|S|These effects usually lessen as your body gets used to the||
0685|071|S|medicine. If any of these effects last or get worse, contact your||
0685|072|S|doctor or pharmacist promptly.||
0685|073|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0685|074|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0685|075|S|substitute.||
0685|076|S|   To reduce the risk of dizziness and lightheadedness, get up||
0685|077|S|slowly when rising from a sitting or lying position.||
0685|078|S|   Remember that this medication has been prescribed because your||
0685|079|S|doctor has judged that the benefit to you is greater than the||
0685|080|S|risk of side effects. Many people using this medication do not||
0685|081|S|have serious side effects.||
0685|082|S|   Tell your doctor right away if you have any serious side||
0685|083|S|effects, including: decreased sexual ability, severe||
0685|084|S|stomach/abdominal pain, difficult/painful swallowing, difficulty||
0685|085|S|urinating, weakness.||
0685|086|S|   Get medical help right away if you have any very serious side||
0685|087|S|effects, including: chest pain, severe dizziness/fainting, high||
0685|088|S|fever, fast/irregular/slow heartbeat, mental/mood changes (such||
0685|089|S|as confusion, hallucinations, memory problems), eye||
0685|090|S|pain/swelling/redness, vision changes (such as seeing rainbows||
0685|091|S|around lights at night).||
0685|092|S|   A very serious allergic reaction to this drug is rare.||
0685|093|S|However, get medical help right away if you notice any symptoms||
0685|094|S|of a serious allergic reaction, including: rash, itching/swelling||
0685|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0685|096|S|breathing.||
0685|097|S|   This is not a complete list of possible side effects. If you||
0685|098|S|notice other effects not listed above, contact your doctor or||
0685|099|S|pharmacist.||
0685|100|S|   In the US -||
0685|101|S|   Call your doctor for medical advice about side effects. You||
0685|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0685|103|S|www.fda.gov/medwatch.||
0685|104|S|   In Canada - Call your doctor for medical advice about side||
0685|105|S|effects. You may report side effects to Health Canada at||
0685|106|S|1-866-234-2345.||
0685|107|B|||
0685|108|P|PRECAUTIONS:  Before taking trihexyphenidyl, tell your doctor or||
0685|109|P|pharmacist if you are allergic to it; or if you have any other||
0685|110|P|allergies. This product may contain inactive ingredients, which||
0685|111|P|can cause allergic reactions or other problems. Talk to your||
0685|112|P|pharmacist for more details.||
0685|113|P|   Before using this medication, tell your doctor or pharmacist||
0685|114|P|your medical history, especially of: glaucoma, breathing problems||
0685|115|P|(such as asthma, emphysema), diarrhea caused by an infection,||
0685|116|P|heart problems (such as angina, heart attack, heart failure,||
0685|117|P|fast/irregular heartbeat), high/low blood pressure,||
0685|118|P|stomach/intestinal problems (such as chronic constipation, ileus,||
0685|119|P|blockage, ulcerative colitis, acid reflux, ulcer), kidney||
0685|120|P|disease, liver disease, mental/mood problems (such as anxiety,||
0685|121|P|dementia, psychosis), certain muscle disease (myasthenia gravis),||
0685|122|P|certain nerve disease (autonomic neuropathy), seizure, stroke,||
0685|123|P|overactive thyroid (hyperthyroidism), problems urinating (such as||
0685|124|P|due to enlarged prostate, neurogenic bladder), personal or family||
0685|125|P|history of a substance use disorder (such as overuse of or||
0685|126|P|addiction to drugs/alcohol).||
0685|127|P|   This drug may make you dizzy or drowsy or blur your vision.||
0685|128|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0685|129|P|drowsy. Do not drive, use machinery, or do anything that needs||
0685|130|P|alertness or clear vision until you can do it safely. Avoid||
0685|131|P|alcoholic beverages. Talk to your doctor if you are using||
0685|132|P|marijuana (cannabis).||
0685|133|P|   This medication decreases saliva production, an effect that||
0685|134|P|can increase gum and tooth problems (such as cavities, gum||
0685|135|P|disease). Take special care with your dental hygiene (such as||
0685|136|P|brushing, flossing) and have regular dental check-ups.||
0685|137|P|   Liquid forms of this product may contain alcohol. Caution is||
0685|138|P|advised if you have diabetes, alcohol dependence, or liver||
0685|139|P|disease. Some medications (such as disulfiram, metronidazole) may||
0685|140|P|cause a serious reaction when combined with alcohol. Tell your||
0685|141|P|doctor if you are taking any medication that should not be used||
0685|142|P|with alcohol. Ask your doctor or pharmacist about using this||
0685|143|P|product safely.||
0685|144|P|   This drug may make you sweat less, making you more likely to||
0685|145|P|get heat stroke. Avoid doing things that may cause you to||
0685|146|P|overheat, such as hard work or exercise in hot weather, or using||
0685|147|P|hot tubs. When the weather is hot, drink a lot of fluids and||
0685|148|P|dress lightly. If you overheat, quickly look for a place to cool||
0685|149|P|down and rest. Get medical help right away if you have a fever||
0685|150|P|that does not go away, mental/mood changes, headache, or||
0685|151|P|dizziness.||
0685|152|P|   Older adults may be more sensitive to the side effects of this||
0685|153|P|drug, especially dizziness, drowsiness, heat stroke, memory||
0685|154|P|problems, difficulty urinating, and constipation. Dizziness and||
0685|155|P|drowsiness can increase the risk of falling.||
0685|156|P|   Children may be more sensitive to the side effects of this||
0685|157|P|drug, especially the effects on heart rate.||
0685|158|P|   During pregnancy, this medication should be used only when||
0685|159|P|clearly needed. Discuss the risks and benefits with your doctor.||
0685|160|P|   It is unknown if this drug passes into breast milk. Consult||
0685|161|P|your doctor before breastfeeding.||
0685|162|B|||
0685|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0685|164|I|medications work or increase your risk for serious side effects.||
0685|165|I|This document does not contain all possible drug interactions.||
0685|166|I|Keep a list of all the products you use (including||
0685|167|I|prescription/nonprescription drugs and herbal products) and share||
0685|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
0685|169|I|the dosage of any medicines without your doctor's approval.||
0685|170|I|   Some products that may interact with this drug are:||
0685|171|I|pramlintide, corticosteroids (such as prednisone), potassium||
0685|172|I|tablets/capsules.||
0685|173|I|   Tell your doctor or pharmacist if you are taking other||
0685|174|I|products that cause drowsiness such as opioid pain or cough||
0685|175|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0685|176|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0685|177|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0685|178|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0685|179|I|diphenhydramine).||
0685|180|I|   Check the labels on all your medicines (such as allergy or||
0685|181|I|cough-and-cold products) because they may contain ingredients||
0685|182|I|that cause drowsiness. Ask your pharmacist about using those||
0685|183|I|products safely.||
0685|184|B|||
0685|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0685|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0685|187|O|poison control center right away. US residents can call||
0685|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0685|189|O|Symptoms of overdose may include: unusually fast/slow heartbeat,||
0685|190|O|slow/shallow breathing, unconsciousness, seizures, loss of||
0685|191|O|coordination, fever, hot/dry/flushed skin, widened pupils, change||
0685|192|O|in vision, change in the amount of urine, confusion,||
0685|193|O|hallucinations.||
0685|194|B|||
0685|195|N|NOTES:  Do not share this medication with others.||
0685|196|N|   Lab and/or medical tests (such as eye exams) should be done||
0685|197|N|while you are taking this medication. Keep all medical and lab||
0685|198|N|appointments. Consult your doctor for more details.||
0685|199|B|||
0685|200|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0685|201|D|remember. If it is near the time of the next dose, skip the||
0685|202|D|missed dose. Take your next dose at the regular time. Do not||
0685|203|D|double the dose to catch up.||
0685|204|B|||
0685|205|R|STORAGE:  Store at room temperature away from light and moisture.||
0685|206|R|Do not store in the bathroom. Keep all medications away from||
0685|207|R|children and pets.||
0685|208|R|   Do not flush medications down the toilet or pour them into a||
0685|209|R|drain unless instructed to do so. Properly discard this product||
0685|210|R|when it is expired or no longer needed. Consult your pharmacist||
0685|211|R|or local waste disposal company.||
0685|212|B|||
0685|213|A|Information last revised October 2025.||
0685|214|A|Copyright(c) 2025 First Databank, Inc.||
0685|215|B|||
0686|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0686|002|Z|does NOT have all possible information about this product. This||
0686|003|Z|information does not assure that this product is safe, effective,||
0686|004|Z|or appropriate for you. This information is not individual||
0686|005|Z|medical advice and does not substitute for the advice of your||
0686|006|Z|health care professional. Always ask your health care||
0686|007|Z|professional for complete information about this product and your||
0686|008|Z|specific health needs.||
0686|009|B|||
0686|010|T|INSULIN DETEMIR - INJECTION||
0686|011|F|(IN-su-lin DET-e-mir)||
0686|012|B|||
0686|013|C|COMMON BRAND NAME(S): Levemir||
0686|014|B|||
0686|015|U|USES:  Insulin detemir is used with a proper diet and exercise||
0686|016|U|program to control high blood sugar in people with diabetes.||
0686|017|U|Controlling high blood sugar helps prevent kidney damage,||
0686|018|U|blindness, nerve problems, loss of limbs, and sexual function||
0686|019|U|problems. Proper control of diabetes may also lessen your risk of||
0686|020|U|a heart attack or stroke.||
0686|021|U|   Insulin detemir is a man-made product that is similar to human||
0686|022|U|insulin. It replaces the insulin that your body would normally||
0686|023|U|make. It acts longer than regular insulin, providing a low,||
0686|024|U|steady level of insulin. It works by helping blood sugar||
0686|025|U|(glucose) get into cells so your body can use it for energy.||
0686|026|U|Insulin detemir may be used with a shorter-acting insulin||
0686|027|U|product. It may also be used alone or with other diabetes drugs||
0686|028|U|(such as metformin, exenatide).||
0686|029|B|||
0686|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0686|031|H|from your pharmacist before you start using this medication and||
0686|032|H|each time you get a refill. Ask your health care professional how||
0686|033|H|to prepare and use this medication. If you have any questions,||
0686|034|H|ask your doctor or pharmacist.||
0686|035|H|   Inject this medication under the skin as directed by your||
0686|036|H|doctor, usually once or twice daily. Insulin detemir is usually||
0686|037|H|injected with the evening meal or at bedtime. If you are using it||
0686|038|H|twice a day, inject as directed by your doctor, usually your||
0686|039|H|first dose in the morning and your second dose with the evening||
0686|040|H|meal, at bedtime, or 12 hours after the morning dose. The||
0686|041|H|injection is given in the stomach area, the thigh, or the back of||
0686|042|H|the upper arm. Do not inject into a vein or muscle because very||
0686|043|H|low blood sugar (hypoglycemia) may occur.||
0686|044|H|   The dosage is based on your medical condition and response to||
0686|045|H|treatment. Measure each dose very carefully because even small||
0686|046|H|changes in the amount of insulin may have a large effect on your||
0686|047|H|blood sugar.||
0686|048|H|   Do not shake the container. Before using, check this product||
0686|049|H|for particles or discoloration. If either is present, do not use||
0686|050|H|the insulin. Before injecting each dose, clean the skin you are||
0686|051|H|going to inject into (the injection site) with rubbing alcohol.||
0686|052|H|Change the injection site each time to lessen injury under the||
0686|053|H|skin (for example, pits/lumps or thickened skin). Do not inject||
0686|054|H|into skin that is red, swollen, itchy, or damaged. To lessen||
0686|055|H|bruising, do not rub the injection site after a shot. Do not||
0686|056|H|inject cold insulin because this can be painful. The insulin||
0686|057|H|container you are currently using can be kept at room||
0686|058|H|temperature. Learn how to store and discard medical supplies||
0686|059|H|safely.||
0686|060|H|   This product should not be mixed with any other insulin. Do||
0686|061|H|not use insulin detemir in an infusion pump.||
0686|062|H|   Do not change brands or types of insulin without directions on||
0686|063|H|how to do so from your doctor.||
0686|064|H|   Do not share your pen device with another person, even if the||
0686|065|H|needle is changed. You may give other people a serious infection,||
0686|066|H|or get a serious infection from them.||
0686|067|H|   Use this medication regularly to get the most benefit from it.||
0686|068|H|To help you remember, use it at the same time(s) each day.||
0686|069|H|   Tell your doctor if your condition does not get better or if||
0686|070|H|it gets worse (your blood sugar is too high or too low).||
0686|071|B|||
0686|072|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
0686|073|S|irritation), weight gain, and swelling of the hands/feet may||
0686|074|S|occur. If any of these effects last or get worse, tell your||
0686|075|S|doctor or pharmacist promptly.||
0686|076|S|   Remember that this medication has been prescribed because your||
0686|077|S|doctor has judged that the benefit to you is greater than the||
0686|078|S|risk of side effects. Many people using this medication do not||
0686|079|S|have serious side effects.||
0686|080|S|   Tell your doctor right away if you have any serious side||
0686|081|S|effects, including: signs of low potassium level in the blood||
0686|082|S|(such as muscle cramps, weakness, irregular heartbeat).||
0686|083|S|   This medication can cause low blood sugar (hypoglycemia). This||
0686|084|S|may occur if you do not get enough calories from food or if you||
0686|085|S|do unusually heavy exercise. Symptoms of low blood sugar include||
0686|086|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
0686|087|S|dizziness, or tingling hands/feet. It is a good habit to carry||
0686|088|S|glucose tablets or gel to treat low blood sugar. If you don't||
0686|089|S|have these reliable forms of glucose, rapidly raise your blood||
0686|090|S|sugar by eating a quick source of sugar such as table sugar,||
0686|091|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
0686|092|S|doctor right away about the reaction and the use of this product.||
0686|093|S|To help prevent low blood sugar, eat meals on a regular schedule,||
0686|094|S|and do not skip meals. Check with your doctor or pharmacist to||
0686|095|S|find out what you should do if you miss a meal.||
0686|096|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0686|097|S|thirst/urination. If these symptoms occur, tell your doctor right||
0686|098|S|away. Your doctor may need to adjust your diabetes medication,||
0686|099|S|exercise program, or diet.||
0686|100|S|   A very serious allergic reaction to this drug is rare.||
0686|101|S|However, get medical help right away if you notice any symptoms||
0686|102|S|of a serious allergic reaction, including: rash, itching/swelling||
0686|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0686|104|S|breathing.||
0686|105|S|   This is not a complete list of possible side effects. If you||
0686|106|S|notice other effects not listed above, contact your doctor or||
0686|107|S|pharmacist.||
0686|108|S|   In the US -||
0686|109|S|   Call your doctor for medical advice about side effects. You||
0686|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0686|111|S|www.fda.gov/medwatch.||
0686|112|S|   In Canada - Call your doctor for medical advice about side||
0686|113|S|effects. You may report side effects to Health Canada at||
0686|114|S|1-866-234-2345.||
0686|115|B|||
0686|116|P|PRECAUTIONS:  Before using insulin detemir, tell your doctor or||
0686|117|P|pharmacist if you are allergic to it; or to other types of||
0686|118|P|insulins; or if you have any other allergies. This product may||
0686|119|P|contain inactive ingredients, which can cause allergic reactions||
0686|120|P|or other problems. Talk to your pharmacist for more details.||
0686|121|P|   Do not use this medication when you have low blood sugar||
0686|122|P|(hypoglycemia).||
0686|123|P|   Before using this medication, tell your doctor or pharmacist||
0686|124|P|your medical history, especially of: adrenal/pituitary gland||
0686|125|P|problems, kidney disease, liver disease, thyroid problems.||
0686|126|P|   You may experience blurred vision, dizziness, or drowsiness||
0686|127|P|due to extremely low or high blood sugar. Do not drive, use||
0686|128|P|machinery, or do anything that needs alertness or clear vision||
0686|129|P|until you can do it safely.||
0686|130|P|   Limit alcohol while taking this medication because it can||
0686|131|P|increase the risk of developing low blood sugar.||
0686|132|P|   It may be harder to control your blood sugar when your body is||
0686|133|P|stressed (such as due to fever, infection, injury, or surgery).||
0686|134|P|Consult your doctor because this may require a change in your||
0686|135|P|treatment plan, medications, or blood sugar testing.||
0686|136|P|   Before having surgery, tell your doctor or dentist about all||
0686|137|P|the products you use (including prescription drugs,||
0686|138|P|nonprescription drugs, and herbal products).||
0686|139|P|   Check your blood sugar readings before and after exercise. You||
0686|140|P|may need a snack before exercising.||
0686|141|P|   If traveling across time zones, ask your doctor about how to||
0686|142|P|adjust your insulin schedule. Take extra insulin and supplies||
0686|143|P|with you.||
0686|144|P|   Older adults may be more sensitive to the side effects of this||
0686|145|P|drug, especially low blood sugar.||
0686|146|P|   Children may be more sensitive to the side effects of this||
0686|147|P|drug, especially low blood sugar.||
0686|148|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
0686|149|P|cause or worsen diabetes. Discuss a plan with your doctor for||
0686|150|P|managing your blood sugar while pregnant. Your doctor may change||
0686|151|P|your diabetes treatment during your pregnancy (such as diet and||
0686|152|P|medications including insulin).||
0686|153|P|   This medication passes into breast milk, but is unlikely to||
0686|154|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0686|155|P|Your insulin needs may change while breastfeeding.||
0686|156|B|||
0686|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0686|158|I|medications work or increase your risk for serious side effects.||
0686|159|I|This document does not contain all possible drug interactions.||
0686|160|I|Keep a list of all the products you use (including||
0686|161|I|prescription/nonprescription drugs and herbal products) and share||
0686|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
0686|163|I|the dosage of any medicines without your doctor's approval.||
0686|164|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0686|165|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0686|166|I|heartbeat you would usually feel when your blood sugar falls too||
0686|167|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0686|168|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0686|169|I|   Many drugs can affect your blood sugar levels, making it more||
0686|170|I|difficult to control your blood sugar. Before you start, stop, or||
0686|171|I|change any medication, talk with your doctor or pharmacist about||
0686|172|I|how the medication may affect your blood sugar. Check your blood||
0686|173|I|sugar regularly as directed by your doctor. Tell your doctor||
0686|174|I|about the results and of any symptoms of high or low blood sugar.||
0686|175|I|(See also Side Effects section.) Your doctor may need to adjust||
0686|176|I|your diabetes medication, exercise program, or diet.||
0686|177|B|||
0686|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0686|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0686|180|O|poison control center right away. US residents can call||
0686|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0686|182|O|Symptoms of overdose may include: signs of low blood sugar such||
0686|183|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
0686|184|B|||
0686|185|N|NOTES:  Do not share this medication, needles, or syringes with||
0686|186|N|others.||
0686|187|N|   Attend a diabetes education program to learn more about how to||
0686|188|N|manage your diabetes with medications, diet, exercise, and||
0686|189|N|regular medical exams.||
0686|190|N|   Learn the symptoms of high and low blood sugar and how to||
0686|191|N|treat low blood sugar. Check your blood sugar regularly as||
0686|192|N|directed and share the results with your doctor.||
0686|193|N|   Lab and/or medical tests (such as liver/kidney function,||
0686|194|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
0686|195|N|should be done while you are taking this medication. Keep all||
0686|196|N|medical and lab appointments.||
0686|197|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
0686|198|B|||
0686|199|D|MISSED DOSE:  It is very important to follow your insulin regimen||
0686|200|D|exactly. Ask your doctor ahead of time what you should do if you||
0686|201|D|miss a dose of insulin.||
0686|202|B|||
0686|203|R|STORAGE:  It is best to refrigerate all unopened insulin||
0686|204|R|products. Unopened insulin detemir may also be stored at room||
0686|205|R|temperature, but it must be thrown away after 42 days. Opened||
0686|206|R|insulin detemir vials may be stored in the refrigerator or at||
0686|207|R|room temperature. Opened insulin detemir cartridges and pens can||
0686|208|R|only be stored at room temperature and should not be||
0686|209|R|refrigerated. Throw away all insulin detemir in use after 42||
0686|210|R|days, even if there is insulin left. Also throw away all insulin||
0686|211|R|products after the expiration date on the package. Do not freeze||
0686|212|R|and do not use insulin that has been frozen.||
0686|213|R|   Protect insulin from light and heat. Do not store in the||
0686|214|R|bathroom. Keep all medications away from children and pets.||
0686|215|R|   Do not flush medications down the toilet or pour them into a||
0686|216|R|drain unless instructed to do so. Properly discard this product||
0686|217|R|when it is expired or no longer needed. Consult your pharmacist||
0686|218|R|or local waste disposal company.||
0686|219|B|||
0686|220|M|MEDICAL ALERT:  Your condition can cause complications in a||
0686|221|M|medical emergency. For information about enrolling in MedicAlert,||
0686|222|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0686|223|B|||
0686|224|A|Information last revised April 2025.||
0686|225|A|Copyright(c) 2025 First Databank, Inc.||
0686|226|B|||
0687|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0687|002|Z|does NOT have all possible information about this product. This||
0687|003|Z|information does not assure that this product is safe, effective,||
0687|004|Z|or appropriate for you. This information is not individual||
0687|005|Z|medical advice and does not substitute for the advice of your||
0687|006|Z|health care professional. Always ask your health care||
0687|007|Z|professional for complete information about this product and your||
0687|008|Z|specific health needs.||
0687|009|B|||
0687|010|T|BENZTROPINE - ORAL||
0687|011|F|(BENZ-troe-peen)||
0687|012|B|||
0687|013|C|COMMON BRAND NAME(S): Cogentin||
0687|014|B|||
0687|015|U|USES:  Benztropine is used to treat symptoms of Parkinson's||
0687|016|U|disease or involuntary movements due to the side effects of||
0687|017|U|certain psychiatric drugs (antipsychotics such as||
0687|018|U|chlorpromazine/haloperidol). Benztropine belongs to a class of||
0687|019|U|medication called anticholinergics that work by blocking a||
0687|020|U|certain natural substance (acetylcholine). This helps decrease||
0687|021|U|muscle stiffness, sweating, and the production of saliva, and||
0687|022|U|helps improve walking ability in people with Parkinson's disease.||
0687|023|U|   Anticholinergics can stop severe muscle spasms of the back,||
0687|024|U|neck, and eyes that are sometimes caused by psychiatric drugs. It||
0687|025|U|can also decrease other side effects such as muscle||
0687|026|U|stiffness/rigidity (extrapyramidal signs-EPS). It is not helpful||
0687|027|U|in treating movement problems caused by tardive dyskinesia and||
0687|028|U|may worsen them. Benztropine should not be used by children||
0687|029|U|younger than 3 years.||
0687|030|B|||
0687|031|H|HOW TO USE:  Take this medication by mouth as directed by your||
0687|032|H|doctor, usually 2 to 4 times a day with meals and at bedtime or||
0687|033|H|as a single dose at bedtime. Your doctor may start you at a low||
0687|034|H|dose and increase your dose slowly to find the best dose for you.||
0687|035|H|The dosage is based on your medical condition, age, and response||
0687|036|H|to treatment.||
0687|037|H|   If you are using the oral solution, measure your dose with a||
0687|038|H|special measuring spoon or device. Do not use a household spoon||
0687|039|H|because it may not provide the correct dose.||
0687|040|H|   Take this medication regularly in order to get the most||
0687|041|H|benefit from it. To help you remember, take it at the same times||
0687|042|H|each day.||
0687|043|H|   Take this medication at least 1 hour before antacids||
0687|044|H|containing magnesium, aluminum, or calcium. Allow at least 1-2||
0687|045|H|hours between doses of benztropine and certain drugs for diarrhea||
0687|046|H|(adsorbent antidiarrheals such as kaolin, pectin, attapulgite).||
0687|047|H|Take this medication at least 2 hours after ketoconazole.||
0687|048|H|Antacids and some drugs for diarrhea may prevent the full||
0687|049|H|absorption of benztropine, and this product may prevent the||
0687|050|H|complete absorption of ketoconazole when these products are taken||
0687|051|H|together.||
0687|052|H|   If you are taking this medication for side effects from||
0687|053|H|another medication, your doctor may instruct you to take it on a||
0687|054|H|regular schedule or only as needed. If you are taking this||
0687|055|H|medication for Parkinson's disease, your doctor may change the||
0687|056|H|dose of your other medications (such as levodopa). Follow your||
0687|057|H|doctor's instructions closely.||
0687|058|H|   When this medication is used for a long time, it may not work||
0687|059|H|as well. Talk with your doctor if this medication stops working||
0687|060|H|well.||
0687|061|H|   Though it helps many people, this medication may sometimes||
0687|062|H|cause addiction. This risk may be higher if you have a substance||
0687|063|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0687|064|H|Take this medication exactly as prescribed to lower the risk of||
0687|065|H|addiction. Ask your doctor or pharmacist for more details.||
0687|066|H|   Do not increase your dose, use it more often, or use it for a||
0687|067|H|longer time than prescribed. Properly stop the medication when so||
0687|068|H|directed. Some conditions may become worse when the drug is||
0687|069|H|suddenly stopped. Your dose may need to be gradually decreased.||
0687|070|H|   It may take 2-3 days before the benefit of this drug takes||
0687|071|H|effect. Tell your doctor if your condition lasts or gets worse.||
0687|072|B|||
0687|073|S|SIDE EFFECTS:  Drowsiness, dizziness, constipation, flushing,||
0687|074|S|nausea, nervousness, blurred vision, or dry mouth may occur as||
0687|075|S|your body adjusts to the medication. If any of these effects last||
0687|076|S|or get worse, tell your doctor or pharmacist promptly.||
0687|077|S|   To reduce the risk of dizziness and lightheadedness, get up||
0687|078|S|slowly when rising from a sitting or lying position.||
0687|079|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0687|080|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0687|081|S|substitute.||
0687|082|S|   Remember that this medication has been prescribed because your||
0687|083|S|doctor has judged that the benefit to you is greater than the||
0687|084|S|risk of side effects. Many people using this medication do not||
0687|085|S|have serious side effects.||
0687|086|S|   Tell your doctor right away if you have any serious side||
0687|087|S|effects, including: high fever, decreased sexual ability, severe||
0687|088|S|stomach/abdominal pain, difficult/painful swallowing, difficulty||
0687|089|S|urinating, weakness.||
0687|090|S|   Get medical help right away if you have any very serious side||
0687|091|S|effects, including: chest pain, severe dizziness/fainting,||
0687|092|S|fast/irregular/slow heartbeat, mental/mood changes (such as||
0687|093|S|confusion, hallucinations, memory problems), eye||
0687|094|S|pain/swelling/redness, vision changes (such as seeing rainbows||
0687|095|S|around lights at night).||
0687|096|S|   A very serious allergic reaction to this drug is rare.||
0687|097|S|However, get medical help right away if you notice any symptoms||
0687|098|S|of a serious allergic reaction, including: rash, itching/swelling||
0687|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0687|100|S|breathing.||
0687|101|S|   This is not a complete list of possible side effects. If you||
0687|102|S|notice other effects not listed above, contact your doctor or||
0687|103|S|pharmacist.||
0687|104|S|   In the US -||
0687|105|S|   Call your doctor for medical advice about side effects. You||
0687|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0687|107|S|www.fda.gov/medwatch.||
0687|108|S|   In Canada - Call your doctor for medical advice about side||
0687|109|S|effects. You may report side effects to Health Canada at||
0687|110|S|1-866-234-2345.||
0687|111|B|||
0687|112|P|PRECAUTIONS:  Before taking benztropine, tell your doctor or||
0687|113|P|pharmacist if you are allergic to it; or if you have any other||
0687|114|P|allergies. This product may contain inactive ingredients, which||
0687|115|P|can cause allergic reactions or other problems. Talk to your||
0687|116|P|pharmacist for more details.||
0687|117|P|   Before using this medication, tell your doctor or pharmacist||
0687|118|P|your medical history, especially of: personal or family history||
0687|119|P|of glaucoma (angle-closure type), breathing problems (such as||
0687|120|P|asthma, emphysema), diarrhea caused by an infection, heart||
0687|121|P|problems (such as angina, heart attack, heart failure,||
0687|122|P|fast/irregular heartbeat), high/low blood pressure, intestinal||
0687|123|P|problems (such as chronic constipation, ileus, ulcerative||
0687|124|P|colitis, bowel obstruction), blockage of the||
0687|125|P|bladder/esophagus/stomach/intestines, kidney disease, liver||
0687|126|P|disease, mental/mood problems (such as anxiety, dementia,||
0687|127|P|psychosis), a certain muscle disease (myasthenia gravis), a||
0687|128|P|certain nerve disease (autonomic neuropathy), seizure, stomach||
0687|129|P|problems (such as acid reflux, hiatal hernia, ulcer), stroke,||
0687|130|P|overactive thyroid (hyperthyroidism), problems urinating (for||
0687|131|P|example, due to enlarged prostate, neurogenic bladder), personal||
0687|132|P|or family history of a substance use disorder (such as overuse of||
0687|133|P|or addiction to drugs/alcohol).||
0687|134|P|   This drug may make you dizzy or drowsy or blur your vision.||
0687|135|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0687|136|P|drowsy. Do not drive, use machinery, or do anything that needs||
0687|137|P|alertness or clear vision until you can do it safely. Avoid||
0687|138|P|alcoholic beverages. Talk to your doctor if you are using||
0687|139|P|marijuana (cannabis).||
0687|140|P|   This medication decreases saliva production, an effect that||
0687|141|P|can increase gum and tooth problems (such as cavities, gum||
0687|142|P|disease). Take special care with your dental hygiene (such as||
0687|143|P|brushing, flossing) and have regular dental check-ups.||
0687|144|P|   Benztropine may make you sweat less, making you more likely to||
0687|145|P|get heat stroke. Avoid doing things that may cause you to||
0687|146|P|overheat, such as hard work or exercise in hot weather, or using||
0687|147|P|hot tubs. When the weather is hot, drink a lot of fluids and||
0687|148|P|dress lightly. If you overheat, quickly look for a place to cool||
0687|149|P|down and rest. Get medical help right away if you have a fever||
0687|150|P|that does not go away, mental/mood changes, headache, or||
0687|151|P|dizziness.||
0687|152|P|   Older adults may be more sensitive to the side effects of this||
0687|153|P|drug, especially dizziness, drowsiness, heat stroke, memory||
0687|154|P|problems, difficulty urinating, and constipation. Dizziness and||
0687|155|P|drowsiness can increase the risk of falling.||
0687|156|P|   Children may be more sensitive to the side effects of this||
0687|157|P|drug, especially effects on heart rate.||
0687|158|P|   During pregnancy, this medication should be used only when||
0687|159|P|clearly needed. Discuss the risks and benefits with your doctor.||
0687|160|P|   It is unknown if this medication passes into breast milk.||
0687|161|P|Consult your doctor before breastfeeding.||
0687|162|B|||
0687|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0687|164|I|medications work or increase your risk for serious side effects.||
0687|165|I|This document does not contain all possible drug interactions.||
0687|166|I|Keep a list of all the products you use (including||
0687|167|I|prescription/nonprescription drugs and herbal products) and share||
0687|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
0687|169|I|the dosage of any medicines without your doctor's approval.||
0687|170|I|   Some products that may interact with this drug are: potassium||
0687|171|I|tablets/capsules, pramlintide.||
0687|172|I|   Tell your doctor or pharmacist if you are taking other||
0687|173|I|products that cause drowsiness such as opioid pain or cough||
0687|174|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0687|175|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0687|176|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0687|177|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0687|178|I|diphenhydramine).||
0687|179|I|   Check the labels on all your medicines (such as allergy or||
0687|180|I|cough-and-cold products) because they may contain ingredients||
0687|181|I|that cause drowsiness. Ask your pharmacist about using those||
0687|182|I|products safely.||
0687|183|I|   This medication may interfere with certain medical/lab tests||
0687|184|I|(including brain scan for Parkinson's disease), possibly causing||
0687|185|I|false test results. Make sure lab personnel and all your doctors||
0687|186|I|know you use this drug.||
0687|187|B|||
0687|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0687|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0687|190|O|poison control center right away. US residents can call||
0687|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0687|192|O|Symptoms of overdose may include: unusually fast/slow heartbeat,||
0687|193|O|slow/shallow breathing, unconsciousness, seizures, loss of||
0687|194|O|coordination, fever, hot/dry/flushed skin, widened pupils, change||
0687|195|O|in vision, change in the amount of urine, confusion,||
0687|196|O|hallucinations.||
0687|197|B|||
0687|198|N|NOTES:  Do not share this medication with others.||
0687|199|N|   Lab and/or medical tests (such as eye exams) should be done||
0687|200|N|while you are taking this medication. Keep all medical and lab||
0687|201|N|appointments. Consult your doctor for more details.||
0687|202|B|||
0687|203|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0687|204|D|remember. If it is near the time of the next dose, skip the||
0687|205|D|missed dose. Take your next dose at the regular time. Do not||
0687|206|D|double the dose to catch up.||
0687|207|B|||
0687|208|R|STORAGE:  Store at room temperature away from light and moisture.||
0687|209|R|Do not store in the bathroom. Keep all medications away from||
0687|210|R|children and pets.||
0687|211|R|   Do not flush medications down the toilet or pour them into a||
0687|212|R|drain unless instructed to do so. Properly discard this product||
0687|213|R|when it is expired or no longer needed. Consult your pharmacist||
0687|214|R|or local waste disposal company.||
0687|215|B|||
0687|216|A|Information last revised October 2025.||
0687|217|A|Copyright(c) 2025 First Databank, Inc.||
0687|218|B|||
0690|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0690|002|Z|does NOT have all possible information about this product. This||
0690|003|Z|information does not assure that this product is safe, effective,||
0690|004|Z|or appropriate for you. This information is not individual||
0690|005|Z|medical advice and does not substitute for the advice of your||
0690|006|Z|health care professional. Always ask your health care||
0690|007|Z|professional for complete information about this product and your||
0690|008|Z|specific health needs.||
0690|009|B|||
0690|010|T|ALBUTEROL (SALBUTAMOL) HFA INHALER - ORAL INHALATION||
0690|011|F|(al-BUE-ter-ol/sal-BUE-ta-mol)||
0690|012|B|||
0690|013|C|COMMON BRAND NAME(S): Proventil HFA, ProAir HFA, Ventolin HFA||
0690|014|B|||
0690|015|U|USES:  Albuterol (also known as salbutamol) is used to prevent||
0690|016|U|and treat wheezing and shortness of breath caused by breathing||
0690|017|U|problems (such as asthma, chronic obstructive pulmonary disease).||
0690|018|U|It is also used to prevent asthma brought on by exercise. It is a||
0690|019|U|quick-relief drug. Albuterol belongs to a class of drugs known as||
0690|020|U|bronchodilators. It works by relaxing the muscles around the||
0690|021|U|airways so that they open up and you can breathe more easily.||
0690|022|U|Controlling symptoms of breathing problems can decrease time lost||
0690|023|U|from work or school.||
0690|024|B|||
0690|025|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0690|026|H|your pharmacist before you start using this medication and each||
0690|027|H|time you get a refill. Follow the illustrated directions for the||
0690|028|H|proper use of this medication and proper cleaning of the||
0690|029|H|mouthpiece. If you have any questions, ask your doctor or||
0690|030|H|pharmacist.||
0690|031|H|   Shake the canister well before using. Follow the instructions||
0690|032|H|for test sprays in the air if you are using a canister for the||
0690|033|H|first time or if you have not used it for 2 weeks or more, or if||
0690|034|H|the inhaler has been dropped. A fine mist is a sign that the||
0690|035|H|inhaler is working properly. Avoid spraying the medication in||
0690|036|H|your eyes.||
0690|037|H|   Inhale this medication by mouth as directed by your doctor,||
0690|038|H|usually every 4 to 6 hours as needed. The dosage is based on your||
0690|039|H|medical condition and response to treatment. Do not increase your||
0690|040|H|dose or use this drug more often than prescribed without your||
0690|041|H|doctor's approval. Using too much of this medication will||
0690|042|H|increase your risk of serious (possibly fatal) side effects.||
0690|043|H|   If you are using this medication to prevent asthma brought on||
0690|044|H|by exercise, inhale as directed by your doctor, usually 2 puffs||
0690|045|H|15 to 30 minutes before exercise.||
0690|046|H|   It is recommended that you use a spacer device with this||
0690|047|H|medication. Ask your doctor or pharmacist for more information.||
0690|048|H|   If two inhalations are prescribed, wait at least 1 minute||
0690|049|H|between them.||
0690|050|H|   If you are using other inhalers at the same time, wait at||
0690|051|H|least 1 minute between the use of each medication.||
0690|052|H|   Always have this quick-relief inhaler with you. Keep track of||
0690|053|H|the number of inhalations you use, and discard the inhaler after||
0690|054|H|you have used the labeled number of inhalations on the product||
0690|055|H|package. Also count test sprays used to prime the inhaler.||
0690|056|H|   Learn which of your inhalers you should use every day||
0690|057|H|(controller drugs) and which you should use if your breathing||
0690|058|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
0690|059|H|time what you should do if you have new or worsening cough or||
0690|060|H|shortness of breath, wheezing, increased sputum, worsening peak||
0690|061|H|flow meter readings, waking up at night with trouble breathing,||
0690|062|H|if you use your quick-relief inhaler more often (more than 2 days||
0690|063|H|a week), or if your quick-relief inhaler does not seem to be||
0690|064|H|working well. Learn when you can treat sudden breathing problems||
0690|065|H|by yourself and when you must get medical help right away.||
0690|066|H|   Tell your doctor if your symptoms do not get better or if they||
0690|067|H|get worse.||
0690|068|B|||
0690|069|S|SIDE EFFECTS:  Nervousness, shaking (tremor), headache,||
0690|070|S|mouth/throat dryness or irritation, changes in taste, cough,||
0690|071|S|nausea or dizziness may occur. If any of these effects last or||
0690|072|S|get worse, tell your doctor or pharmacist promptly.||
0690|073|S|   Remember that this medication has been prescribed because your||
0690|074|S|doctor has judged that the benefit to you is greater than the||
0690|075|S|risk of side effects. Many people using this medication do not||
0690|076|S|have serious side effects.||
0690|077|S|   This medication may raise your blood pressure. Check your||
0690|078|S|blood pressure regularly and tell your doctor if the results are||
0690|079|S|high.||
0690|080|S|   Tell your doctor right away if you have any serious side||
0690|081|S|effects, including: fast/pounding heartbeat.||
0690|082|S|   Get medical help right away if you have any very serious side||
0690|083|S|effects, including: chest pain, irregular heartbeat, rapid||
0690|084|S|breathing, confusion.||
0690|085|S|   Rarely, this medication has caused severe (rarely fatal),||
0690|086|S|sudden worsening of breathing problems/asthma (paradoxical||
0690|087|S|bronchospasm). If you experience sudden wheezing, get medical||
0690|088|S|help right away.||
0690|089|S|   A very serious allergic reaction to this drug is rare.||
0690|090|S|However, get medical help right away if you notice any symptoms||
0690|091|S|of a serious allergic reaction, including: rash, itching/swelling||
0690|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0690|093|S|breathing.||
0690|094|S|   This is not a complete list of possible side effects. If you||
0690|095|S|notice other effects not listed above, contact your doctor or||
0690|096|S|pharmacist.||
0690|097|S|   In the US -||
0690|098|S|   Call your doctor for medical advice about side effects. You||
0690|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0690|100|S|www.fda.gov/medwatch.||
0690|101|S|   In Canada - Call your doctor for medical advice about side||
0690|102|S|effects. You may report side effects to Health Canada at||
0690|103|S|1-866-234-2345.||
0690|104|B|||
0690|105|P|PRECAUTIONS:  Before using albuterol, tell your doctor or||
0690|106|P|pharmacist if you are allergic to it; or if you have had a||
0690|107|P|serious reaction to similar drugs (such as levalbuterol,||
0690|108|P|metaproterenol, terbutaline); or if you have any other allergies.||
0690|109|P|This product may contain inactive ingredients, which can cause||
0690|110|P|allergic reactions or other problems. Talk to your pharmacist for||
0690|111|P|more details.||
0690|112|P|   Before using this medication, tell your doctor or pharmacist||
0690|113|P|your medical history, especially of: heart problems (such as||
0690|114|P|irregular heartbeat, angina, heart attack), high blood pressure,||
0690|115|P|seizure.||
0690|116|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0690|117|P|can make you more dizzy. Do not drive, use machinery, or do||
0690|118|P|anything that needs alertness until you can do it safely. Limit||
0690|119|P|alcoholic beverages. Talk to your doctor if you are using||
0690|120|P|marijuana (cannabis).||
0690|121|P|   Before having surgery, tell your doctor or dentist about all||
0690|122|P|the products you use (including prescription drugs,||
0690|123|P|nonprescription drugs, and herbal products).||
0690|124|P|   During pregnancy, this medication should be used only when||
0690|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
0690|126|P|   It is unknown if this medication passes into breast milk.||
0690|127|P|Consult your doctor before breastfeeding.||
0690|128|B|||
0690|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0690|130|I|medications work or increase your risk for serious side effects.||
0690|131|I|This document does not contain all possible drug interactions.||
0690|132|I|Keep a list of all the products you use (including||
0690|133|I|prescription/nonprescription drugs and herbal products) and share||
0690|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
0690|135|I|the dosage of any medicines without your doctor's approval.||
0690|136|I|   Albuterol is very similar to levalbuterol. Do not use||
0690|137|I|medications containing levalbuterol while using albuterol.||
0690|138|B|||
0690|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0690|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0690|141|O|poison control center right away. US residents can call||
0690|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0690|143|O|Symptoms of overdose may include: fast/pounding/irregular||
0690|144|O|heartbeat, severe shaking (tremors), seizures.||
0690|145|B|||
0690|146|N|NOTES:  Do not share this medication with others.||
0690|147|N|   Lab and/or medical tests (such as lung function, blood||
0690|148|N|pressure) should be done while you are using this medication.||
0690|149|N|Keep all medical and lab appointments. Consult your doctor for||
0690|150|N|more details.||
0690|151|N|   Avoid allergens/irritants such as smoke, pollen, pet dander,||
0690|152|N|dust, or molds that may worsen breathing problems.||
0690|153|N|   Learn to use a peak flow meter, use it daily, and promptly||
0690|154|N|report worsening breathing problems (such as readings in the||
0690|155|N|yellow/red range, increased use of quick-relief inhalers).||
0690|156|N|   Ask your doctor or pharmacist whether you should have an||
0690|157|N|annual flu shot.||
0690|158|B|||
0690|159|D|MISSED DOSE:  If you are using this medication on a prescribed||
0690|160|D|schedule and miss a dose, use it as soon as you remember. If it||
0690|161|D|is near the time of the next dose, skip the missed dose. Use your||
0690|162|D|next dose at the regular time. Do not double the dose to catch||
0690|163|D|up.||
0690|164|B|||
0690|165|R|STORAGE:  Store at room temperature away from light. It is best||
0690|166|R|to store the inhaler with the mouthpiece down. Do not puncture||
0690|167|R|the canister or expose it to high heat or open flame. Different||
0690|168|R|brands of this medication have different storage needs. Check the||
0690|169|R|product package for instructions on how to store your brand, or||
0690|170|R|ask your pharmacist. Keep all medications away from children and||
0690|171|R|pets.||
0690|172|R|   Do not flush medications down the toilet or pour them into a||
0690|173|R|drain unless instructed to do so. Properly discard this product||
0690|174|R|when it is expired or no longer needed. Consult your pharmacist||
0690|175|R|or local waste disposal company.||
0690|176|B|||
0690|177|M|MEDICAL ALERT:  Your condition can cause complications in a||
0690|178|M|medical emergency. For information about enrolling in MedicAlert,||
0690|179|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0690|180|B|||
0690|181|A|Information last revised October 2024.||
0690|182|A|Copyright(c) 2025 First Databank, Inc.||
0690|183|B|||
0691|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0691|002|Z|does NOT have all possible information about this product. This||
0691|003|Z|information does not assure that this product is safe, effective,||
0691|004|Z|or appropriate for you. This information is not individual||
0691|005|Z|medical advice and does not substitute for the advice of your||
0691|006|Z|health care professional. Always ask your health care||
0691|007|Z|professional for complete information about this product and your||
0691|008|Z|specific health needs.||
0691|009|B|||
0691|010|T|ETHOPROPAZINE - ORAL||
0691|011|F|(eth-oh-PRO-pa-zeen)||
0691|012|B|||
0691|013|U|USES:  This medication is used to treat symptoms of Parkinson's||
0691|014|U|disease or movement disorders (extrapyramidal signs-EPS) due to||
0691|015|U|the side effects of certain psychiatric drugs (antipsychotics||
0691|016|U|such as chlorpromazine/haloperidol). Ethopropazine belongs to a||
0691|017|U|class of medications called phenothiazines. It works by blocking||
0691|018|U|a certain natural substance (acetylcholine). This helps to||
0691|019|U|decrease symptoms such as muscle stiffness/spasms, shaking, and||
0691|020|U|excess saliva. Ethopropazine does not treat movement problems||
0691|021|U|caused by tardive dyskinesia and may worsen them.||
0691|022|B|||
0691|023|H|HOW TO USE:  Take this medication by mouth with or without food||
0691|024|H|as directed by your doctor, usually 2 to 3 times a day. Your||
0691|025|H|doctor may direct you to start this medication at a low dose and||
0691|026|H|gradually increase your dose to find the best dose for you. The||
0691|027|H|dosage is based on your medical condition and response to||
0691|028|H|treatment.||
0691|029|H|   Take this medication regularly to get the most benefit from||
0691|030|H|it. To help you remember, take it at the same times each day.||
0691|031|H|   Tell your doctor if your condition does not get better or if||
0691|032|H|it gets worse.||
0691|033|B|||
0691|034|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, blurred vision,||
0691|035|S|constipation, or dry mouth may occur as your body adjusts to the||
0691|036|S|medication. If any of these effects last or get worse, tell your||
0691|037|S|doctor or pharmacist promptly.||
0691|038|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0691|039|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0691|040|S|substitute.||
0691|041|S|   Remember that this medication has been prescribed because your||
0691|042|S|doctor has judged that the benefit to you is greater than the||
0691|043|S|risk of side effects. Many people using this medication do not||
0691|044|S|have serious side effects.||
0691|045|S|   Tell your doctor right away if you have any very serious side||
0691|046|S|effects, including: severe stomach/abdominal pain,||
0691|047|S|difficult/painful swallowing, numb/tingling skin, difficulty||
0691|048|S|urinating, easy bleeding/bruising, signs of infection (such as||
0691|049|S|sore throat that doesn't go away, chills), mental/mood changes||
0691|050|S|(such as confusion, hallucinations, memory problems).||
0691|051|S|   Get medical help right away if you have any very serious side||
0691|052|S|effects, including: eye pain/swelling/redness, vision changes||
0691|053|S|(such as seeing rainbows around lights at night).||
0691|054|S|   This medication may rarely cause a very serious condition||
0691|055|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0691|056|S|right away if you have any of the following symptoms: fever,||
0691|057|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
0691|058|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
0691|059|S|signs of kidney problems (such as change in the amount of urine).||
0691|060|S|   A very serious allergic reaction to this drug is rare.||
0691|061|S|However, get medical help right away if you notice any symptoms||
0691|062|S|of a serious allergic reaction, including: rash, itching/swelling||
0691|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0691|064|S|breathing.||
0691|065|S|   This is not a complete list of possible side effects. If you||
0691|066|S|notice other effects not listed above, contact your doctor or||
0691|067|S|pharmacist.||
0691|068|S|   In the US -||
0691|069|S|   Call your doctor for medical advice about side effects. You||
0691|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0691|071|S|www.fda.gov/medwatch.||
0691|072|S|   In Canada - Call your doctor for medical advice about side||
0691|073|S|effects. You may report side effects to Health Canada at||
0691|074|S|1-866-234-2345.||
0691|075|B|||
0691|076|P|PRECAUTIONS:  Before taking ethopropazine, tell your doctor or||
0691|077|P|pharmacist if you are allergic to it; or to other phenothiazines||
0691|078|P|(such as chlorpromazine); or if you have any other allergies.||
0691|079|P|This product may contain inactive ingredients, which can cause||
0691|080|P|allergic reactions or other problems. Talk to your pharmacist for||
0691|081|P|more details.||
0691|082|P|   Before using this medication, tell your doctor or pharmacist||
0691|083|P|your medical history, especially of: personal or family history||
0691|084|P|of glaucoma, breathing problems (such as asthma, emphysema),||
0691|085|P|heart problems (such as chest pain, heart attack, heart failure,||
0691|086|P|fast/irregular heartbeat), high blood pressure,||
0691|087|P|stomach/intestinal problems (such as blockage, ileus, ulcer,||
0691|088|P|ulcerative colitis), esophageal problems (such as heartburn,||
0691|089|P|hiatal hernia), kidney disease, liver disease, mental/mood||
0691|090|P|problems (such as anxiety, psychosis), myasthenia gravis,||
0691|091|P|seizure, overactive thyroid (hyperthyroidism), difficulty||
0691|092|P|urinating (for example, due to enlarged prostate).||
0691|093|P|   This drug may make you dizzy or drowsy or blur your vision.||
0691|094|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0691|095|P|drowsy. Do not drive, use machinery, or do anything that needs||
0691|096|P|alertness or clear vision until you can do it safely. Avoid||
0691|097|P|alcoholic beverages. Talk to your doctor if you are using||
0691|098|P|marijuana (cannabis).||
0691|099|P|   This drug may make you sweat less, making you more likely to||
0691|100|P|get heat stroke. Avoid doing things that may cause you to||
0691|101|P|overheat, such as hard work or exercise in hot weather, or using||
0691|102|P|hot tubs. When the weather is hot, drink a lot of fluids and||
0691|103|P|dress lightly. If you overheat, quickly look for a place to cool||
0691|104|P|down and rest. Get medical help right away if you have a fever||
0691|105|P|that does not go away, mental/mood changes, headache, or||
0691|106|P|dizziness.||
0691|107|P|   Before having surgery, tell your doctor or dentist about all||
0691|108|P|the products you use (including prescription drugs,||
0691|109|P|nonprescription drugs, and herbal products).||
0691|110|P|   Older adults may be more sensitive to the effects of this||
0691|111|P|drug, especially dizziness, difficulty urinating, and||
0691|112|P|constipation.||
0691|113|P|   During pregnancy, this medication should be used only when||
0691|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
0691|115|P|   It is unknown if this drug passes into breast milk. Consult||
0691|116|P|your doctor before breastfeeding.||
0691|117|B|||
0691|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0691|119|I|medications work or increase your risk for serious side effects.||
0691|120|I|This document does not contain all possible drug interactions.||
0691|121|I|Keep a list of all the products you use (including||
0691|122|I|prescription/nonprescription drugs and herbal products) and share||
0691|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
0691|124|I|the dosage of any medicines without your doctor's approval.||
0691|125|I|   Some products that may interact with this drug include:||
0691|126|I|metoclopramide, potassium tablets/capsules, pramlintide.||
0691|127|I|   Tell your doctor or pharmacist if you are taking other||
0691|128|I|products that cause drowsiness including alcohol, marijuana||
0691|129|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0691|130|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0691|131|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0691|132|I|codeine).||
0691|133|I|   Check the labels on all your medicines (such as allergy or||
0691|134|I|cough-and-cold products) because they may contain ingredients||
0691|135|I|that cause drowsiness. Ask your pharmacist about using those||
0691|136|I|products safely.||
0691|137|B|||
0691|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0691|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0691|140|O|poison control center right away. US residents can call||
0691|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0691|142|O|Symptoms of overdose may include: fast/slow/irregular heartbeat,||
0691|143|O|severe drowsiness/dizziness, slow/shallow breathing, seizures,||
0691|144|O|mental/mood changes (such as confusion, restlessness).||
0691|145|B|||
0691|146|N|NOTES:  Do not share this medication with others.||
0691|147|N|   Lab and/or medical tests (such as complete blood count, eye||
0691|148|N|exams) should be done while you are taking this medication. Keep||
0691|149|N|all medical and lab appointments. Consult your doctor for more||
0691|150|N|details.||
0691|151|B|||
0691|152|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0691|153|D|remember. If it is near the time of the next dose, skip the||
0691|154|D|missed dose. Take your next dose at the regular time. Do not||
0691|155|D|double the dose to catch up.||
0691|156|B|||
0691|157|R|STORAGE:  Store at room temperature away from light and moisture.||
0691|158|R|Do not store in the bathroom. Keep all medications away from||
0691|159|R|children and pets.||
0691|160|R|   Do not flush medications down the toilet or pour them into a||
0691|161|R|drain unless instructed to do so. Properly discard this product||
0691|162|R|when it is expired or no longer needed. Consult your pharmacist||
0691|163|R|or local waste disposal company.||
0691|164|B|||
0691|165|A|Information last revised April 2025.||
0691|166|A|Copyright(c) 2025 First Databank, Inc.||
0691|167|B|||
0694|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0694|002|Z|does NOT have all possible information about this product. This||
0694|003|Z|information does not assure that this product is safe, effective,||
0694|004|Z|or appropriate for you. This information is not individual||
0694|005|Z|medical advice and does not substitute for the advice of your||
0694|006|Z|health care professional. Always ask your health care||
0694|007|Z|professional for complete information about this product and your||
0694|008|Z|specific health needs.||
0694|009|B|||
0694|010|T|HALCINONIDE - TOPICAL||
0694|011|F|(hal-SIN-oh-nide)||
0694|012|B|||
0694|013|C|COMMON BRAND NAME(S): Halog||
0694|014|B|||
0694|015|U|USES:  This medication is used to treat a variety of skin||
0694|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0694|017|U|Halcinonide reduces the swelling, itching, and redness that can||
0694|018|U|occur in these types of conditions. This medication is a strong||
0694|019|U|corticosteroid.||
0694|020|B|||
0694|021|H|HOW TO USE:  Use this medication on the skin only. However, do||
0694|022|H|not use it on the face, groin, or underarms unless directed to do||
0694|023|H|so by your doctor.||
0694|024|H|   Wash and dry your hands. Before applying the medication, clean||
0694|025|H|and dry the affected area. Apply a thin film of the medication to||
0694|026|H|the affected area and gently rub in as directed by your doctor,||
0694|027|H|usually 2 to 3 times daily. Do not cover, bandage, or wrap the||
0694|028|H|area unless directed to do so by your doctor.||
0694|029|H|   After applying the medication, wash your hands unless you are||
0694|030|H|using this medication to treat the hands. When applying this||
0694|031|H|medication near the eyes, avoid getting it in the eyes as this||
0694|032|H|may worsen or cause glaucoma. Also, avoid getting this medication||
0694|033|H|in the eyes, nose, or mouth. If you get the medication in these||
0694|034|H|areas, rinse with plenty of water.||
0694|035|H|   Use this medication only for the condition for which it was||
0694|036|H|prescribed. Do not use it for longer than prescribed.||
0694|037|H|   Tell your doctor if your condition lasts or gets worse.||
0694|038|B|||
0694|039|S|SIDE EFFECTS:  Burning, itching, irritation, or dryness may occur||
0694|040|S|when this medication is first applied to the skin. This should||
0694|041|S|disappear in a few days as your body adjusts to the medication.||
0694|042|S|If any of these effects last or get worse, notify your doctor or||
0694|043|S|pharmacist promptly.||
0694|044|S|   Remember that this medication has been prescribed because your||
0694|045|S|doctor has judged that the benefit to you is greater than the||
0694|046|S|risk of side effects. Many people using this medication do not||
0694|047|S|have serious side effects.||
0694|048|S|   Tell your doctor right away if you have any serious side||
0694|049|S|effects, including: stretch marks, skin thinning/discoloration,||
0694|050|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0694|051|S|(folliculitis).||
0694|052|S|   Skin infections can become worse when this medication is used.||
0694|053|S|Notify your doctor if redness, swelling, or irritation does not||
0694|054|S|improve.||
0694|055|S|   Rarely, it is possible this medication will be absorbed from||
0694|056|S|the skin into the bloodstream. This can lead to side effects of||
0694|057|S|too much corticosteroid. These side effects are more likely in||
0694|058|S|children, and in people who use this medication for a long time||
0694|059|S|or over large areas of the skin. Tell your doctor right away if||
0694|060|S|any of the following side effects occur: unusual/extreme||
0694|061|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0694|062|S|thirst/urination, vision problems.||
0694|063|S|   A very serious allergic reaction to this drug is rare.||
0694|064|S|However, get medical help right away if you notice any symptoms||
0694|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0694|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0694|067|S|breathing.||
0694|068|S|   This is not a complete list of possible side effects. If you||
0694|069|S|notice other effects not listed above, contact your doctor or||
0694|070|S|pharmacist.||
0694|071|S|   In the US -||
0694|072|S|   Call your doctor for medical advice about side effects. You||
0694|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0694|074|S|www.fda.gov/medwatch.||
0694|075|S|   In Canada - Call your doctor for medical advice about side||
0694|076|S|effects. You may report side effects to Health Canada at||
0694|077|S|1-866-234-2345.||
0694|078|B|||
0694|079|P|PRECAUTIONS:  Before using halcinonide, tell your doctor or||
0694|080|P|pharmacist if you are allergic to it; or to other corticosteroids||
0694|081|P|(such as hydrocortisone, prednisone); or if you have any other||
0694|082|P|allergies. This product may contain inactive ingredients, which||
0694|083|P|can cause allergic reactions or other problems. Talk to your||
0694|084|P|pharmacist for more details.||
0694|085|P|   Before using this medication, tell your doctor or pharmacist||
0694|086|P|your medical history, especially of: poor blood circulation,||
0694|087|P|immune system problems.||
0694|088|P|   Do not use if there is an infection or sore present in the||
0694|089|P|area to be treated.||
0694|090|P|   Rarely, using corticosteroid medications for a long time or||
0694|091|P|over large areas of skin can make it more difficult for your body||
0694|092|P|to respond to physical stress. Before having surgery or emergency||
0694|093|P|treatment, or if you get a serious illness/injury, tell your||
0694|094|P|doctor or dentist that you are using this medication or have used||
0694|095|P|this medication within the past few months.||
0694|096|P|   Though it is unlikely, this medication may temporarily slow||
0694|097|P|down a child's growth if used for a long time. See the doctor||
0694|098|P|regularly so your child's height can be checked.||
0694|099|P|   During pregnancy, this medication should be used only when||
0694|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0694|101|P|   It is unknown if this drug passes into breast milk when||
0694|102|P|applied to the skin. Other medications in this class pass into||
0694|103|P|breast milk when taken by mouth. Consult your doctor before||
0694|104|P|breastfeeding.||
0694|105|B|||
0694|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0694|107|I|medications work or increase your risk for serious side effects.||
0694|108|I|This document does not contain all possible drug interactions.||
0694|109|I|Keep a list of all the products you use (including||
0694|110|I|prescription/nonprescription drugs and herbal products) and share||
0694|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0694|112|I|the dosage of any medicines without your doctor's approval.||
0694|113|B|||
0694|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0694|115|O|has overdosed and has serious symptoms such as passing out or||
0694|116|O|trouble breathing, call 911. Otherwise, call a poison control||
0694|117|O|center right away. US residents can call 1-800-222-1222. Canada||
0694|118|O|residents can call 1-844-764-7669.||
0694|119|B|||
0694|120|N|NOTES:  Do not share this medication with others.||
0694|121|N|   This medication has been prescribed for your current condition||
0694|122|N|only. Do not use it later for other skin problems unless told to||
0694|123|N|do so by your doctor. A different medication may be necessary in||
0694|124|N|those cases.||
0694|125|N|   Lab and/or medical tests (such as adrenal gland function) may||
0694|126|N|be done while you are using this medication, especially if you||
0694|127|N|use this drug for an extended period of time or apply it over||
0694|128|N|large areas of the body. Keep all medical and lab appointments.||
0694|129|N|Consult your doctor for more details.||
0694|130|B|||
0694|131|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0694|132|D|If it is near the time of the next dose, skip the missed dose.||
0694|133|D|Use your next dose at the regular time. Do not double the dose to||
0694|134|D|catch up.||
0694|135|B|||
0694|136|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
0694|137|R|medications away from children and pets.||
0694|138|R|   Do not flush medications down the toilet or pour them into a||
0694|139|R|drain unless instructed to do so. Properly discard this product||
0694|140|R|when it is expired or no longer needed. Consult your pharmacist||
0694|141|R|or local waste disposal company.||
0694|142|B|||
0694|143|A|Information last revised October 2024.||
0694|144|A|Copyright(c) 2025 First Databank, Inc.||
0694|145|B|||
0695|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0695|002|Z|does NOT have all possible information about this product. This||
0695|003|Z|information does not assure that this product is safe, effective,||
0695|004|Z|or appropriate for you. This information is not individual||
0695|005|Z|medical advice and does not substitute for the advice of your||
0695|006|Z|health care professional. Always ask your health care||
0695|007|Z|professional for complete information about this product and your||
0695|008|Z|specific health needs.||
0695|009|B|||
0695|010|T|MOMETASONE - TOPICAL||
0695|011|F|(mow-MET-uh-sown)||
0695|012|B|||
0695|013|C|COMMON BRAND NAME(S): Elocon||
0695|014|B|||
0695|015|U|USES:  This medication is used to treat skin conditions such as||
0695|016|U|eczema, psoriasis, allergies, and rash. Mometasone decreases||
0695|017|U|swelling (inflammation), itching, and redness. Mometasone is a||
0695|018|U|medium-strength corticosteroid. This medication is available in||
0695|019|U|several forms including cream, ointment, and lotion (solution).||
0695|020|U|Your doctor will choose the type of product based on the skin||
0695|021|U|condition/area of the body being treated.||
0695|022|B|||
0695|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0695|024|H|from your pharmacist before you start using this medication and||
0695|025|H|each time you get a refill. If you have any questions, ask your||
0695|026|H|doctor or pharmacist.||
0695|027|H|   This medication is for use only on certain areas of skin: do||
0695|028|H|not use it on the face, groin, or underarms, or for diaper rash,||
0695|029|H|unless directed to do so by your doctor.||
0695|030|H|   Wash and dry your hands before using. Clean and dry the||
0695|031|H|affected area. Apply as directed by your doctor, usually a thin||
0695|032|H|film of medication to the affected area once daily. Gently rub||
0695|033|H|in. Do not cover the treated area with bandages or other||
0695|034|H|dressings unless instructed to do so by your doctor.||
0695|035|H|   Do not wash or rinse the medication off immediately after||
0695|036|H|applying it. Wash your hands with soap and water after each use||
0695|037|H|unless you are using this medication to treat the hands. Avoid||
0695|038|H|getting this medication in your eyes, nose, or mouth. If this||
0695|039|H|occurs, rinse thoroughly with water and call your doctor if||
0695|040|H|irritation lasts.||
0695|041|H|   Use this medication regularly to get the most benefit from it.||
0695|042|H|To help you remember, use it at the same time each day. Do not||
0695|043|H|apply large amounts of this medication, use it more often, or use||
0695|044|H|it for longer than prescribed. Your condition will not improve||
0695|045|H|any faster, and your risk of side effects may increase.||
0695|046|H|   Tell your doctor if your condition does not get better after 2||
0695|047|H|weeks of treatment or if it gets worse.||
0695|048|B|||
0695|049|S|SIDE EFFECTS:  Burning, itching, or stinging may occur when you||
0695|050|S|apply this medication, but usually only lasts a short time. If||
0695|051|S|any of these effects last or get worse, tell your doctor or||
0695|052|S|pharmacist promptly.||
0695|053|S|   Remember that this medication has been prescribed because your||
0695|054|S|doctor has judged that the benefit to you is greater than the||
0695|055|S|risk of side effects. Many people using this medication do not||
0695|056|S|have serious side effects.||
0695|057|S|   Tell your doctor right away if you have any serious side||
0695|058|S|effects, including: stretch marks, skin thinning/discoloration,||
0695|059|S|acne, small red bumps on the skin (folliculitis).||
0695|060|S|   Rarely, it is possible this medication will be absorbed from||
0695|061|S|the skin into the bloodstream. This can lead to side effects of||
0695|062|S|too much corticosteroid. These side effects are more likely in||
0695|063|S|children, and in people who use this medication for a long time||
0695|064|S|or over large areas of the skin. Tell your doctor right away if||
0695|065|S|any of the following side effects occur: unusual/extreme||
0695|066|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0695|067|S|thirst/urination, vision problems.||
0695|068|S|   A very serious allergic reaction to this drug is rare.||
0695|069|S|However, get medical help right away if you notice any symptoms||
0695|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0695|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0695|072|S|breathing.||
0695|073|S|   This is not a complete list of possible side effects. If you||
0695|074|S|notice other effects not listed above, contact your doctor or||
0695|075|S|pharmacist.||
0695|076|S|   In the US -||
0695|077|S|   Call your doctor for medical advice about side effects. You||
0695|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0695|079|S|www.fda.gov/medwatch.||
0695|080|S|   In Canada - Call your doctor for medical advice about side||
0695|081|S|effects. You may report side effects to Health Canada at||
0695|082|S|1-866-234-2345.||
0695|083|B|||
0695|084|P|PRECAUTIONS:  Before using mometasone, tell your doctor or||
0695|085|P|pharmacist if you are allergic to it; or if you have any other||
0695|086|P|allergies. This product may contain inactive ingredients, which||
0695|087|P|can cause allergic reactions or other problems. Talk to your||
0695|088|P|pharmacist for more details.||
0695|089|P|   Before using this medication, tell your doctor or pharmacist||
0695|090|P|your medical history, especially of: poor blood circulation,||
0695|091|P|diabetes, immune system problems.||
0695|092|P|   Corticosteroids can make skin infections worse and more||
0695|093|P|difficult to treat. Tell your doctor if you have a skin infection||
0695|094|P|so it can be treated. Tell your doctor promptly if your condition||
0695|095|P|does not improve or if you have worsening skin symptoms.||
0695|096|P|   Rarely, using corticosteroid medications for a long time or||
0695|097|P|over large areas of skin can make it more difficult for your body||
0695|098|P|to respond to physical stress. Before having surgery or emergency||
0695|099|P|treatment, or if you get a serious illness/injury, tell your||
0695|100|P|doctor or dentist that you are using this medication or have used||
0695|101|P|this medication within the past few months.||
0695|102|P|   Before having surgery, tell your doctor or dentist about all||
0695|103|P|the products you use (including prescription drugs,||
0695|104|P|nonprescription drugs, and herbal products).||
0695|105|P|   Though it is unlikely, this medication may temporarily slow||
0695|106|P|down a child's growth if used for a long time. See the doctor||
0695|107|P|regularly so your child's height can be checked.||
0695|108|P|   During pregnancy, this medication should be used only when||
0695|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
0695|110|P|   It is unknown if this medication passes into breast milk.||
0695|111|P|Consult your doctor before breastfeeding.||
0695|112|B|||
0695|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0695|114|I|medications work or increase your risk for serious side effects.||
0695|115|I|This document does not contain all possible drug interactions.||
0695|116|I|Keep a list of all the products you use (including||
0695|117|I|prescription/nonprescription drugs and herbal products) and share||
0695|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
0695|119|I|the dosage of any medicines without your doctor's approval.||
0695|120|B|||
0695|121|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0695|122|O|has overdosed and has serious symptoms such as passing out or||
0695|123|O|trouble breathing, call 911. Otherwise, call a poison control||
0695|124|O|center right away. US residents can call 1-800-222-1222. Canada||
0695|125|O|residents can call 1-844-764-7669.||
0695|126|B|||
0695|127|N|NOTES:  Do not share this medication with others.||
0695|128|N|   This medication has been prescribed for your current condition||
0695|129|N|only. Do not use it later for other skin problems unless told to||
0695|130|N|do so by your doctor. A different medication may be necessary in||
0695|131|N|those cases.||
0695|132|N|   Lab and/or medical tests (such as adrenal gland function) may||
0695|133|N|be done while you are using this medication, especially if you||
0695|134|N|use this drug for an extended period of time or apply it over||
0695|135|N|large areas of the body. Keep all medical and lab appointments.||
0695|136|N|Consult your doctor for more details.||
0695|137|B|||
0695|138|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0695|139|D|If it is near the time of the next dose, skip the missed dose.||
0695|140|D|Use your next dose at the regular time. Do not double the dose to||
0695|141|D|catch up.||
0695|142|B|||
0695|143|R|STORAGE:  Store at room temperature. Keep all medications away||
0695|144|R|from children and pets.||
0695|145|R|   Do not flush medications down the toilet or pour them into a||
0695|146|R|drain unless instructed to do so. Properly discard this product||
0695|147|R|when it is expired or no longer needed. Consult your pharmacist||
0695|148|R|or local waste disposal company.||
0695|149|B|||
0695|150|A|Information last revised November 2024.||
0695|151|A|Copyright(c) 2025 First Databank, Inc.||
0695|152|B|||
0696|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0696|002|Z|does NOT have all possible information about this product. This||
0696|003|Z|information does not assure that this product is safe, effective,||
0696|004|Z|or appropriate for you. This information is not individual||
0696|005|Z|medical advice and does not substitute for the advice of your||
0696|006|Z|health care professional. Always ask your health care||
0696|007|Z|professional for complete information about this product and your||
0696|008|Z|specific health needs.||
0696|009|B|||
0696|010|T|ALCLOMETASONE - TOPICAL||
0696|011|F|(AL-kloe-MET-a-sone)||
0696|012|B|||
0696|013|C|COMMON BRAND NAME(S): Aclovate||
0696|014|B|||
0696|015|U|USES:  This medication is used to treat a variety of skin||
0696|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0696|017|U|Alclometasone reduces the swelling, itching, and redness that can||
0696|018|U|occur in these types of conditions. This medication is a low- to||
0696|019|U|medium-strength corticosteroid.||
0696|020|B|||
0696|021|H|HOW TO USE:  Use this medication on the skin only. However, do||
0696|022|H|not use it on the face, groin, or underarms, or for diaper rash,||
0696|023|H|unless directed to do so by your doctor.||
0696|024|H|   Wash and dry your hands before using. Clean and dry the||
0696|025|H|affected area. Apply a thin film of medication to the affected||
0696|026|H|area and gently rub in as directed by your doctor, usually 2 to 3||
0696|027|H|times daily. Do not bandage, cover, or wrap the area unless||
0696|028|H|directed to do so by your doctor.||
0696|029|H|   After applying the medication, wash your hands, unless you are||
0696|030|H|using this medication to treat the hands. When applying this||
0696|031|H|medication near the eyes, avoid getting it in the eyes because||
0696|032|H|this may worsen or cause glaucoma. Also, avoid getting this||
0696|033|H|medication in the eyes, nose, or mouth. If you get the medication||
0696|034|H|in these areas, rinse with plenty of water.||
0696|035|H|   Use this medication only for the condition for which it was||
0696|036|H|prescribed. Do not use it on a child for longer than 3 weeks in a||
0696|037|H|row unless directed to do so by the doctor.||
0696|038|H|   Tell your doctor if your condition lasts or gets worse after 2||
0696|039|H|weeks.||
0696|040|B|||
0696|041|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
0696|042|S|or redness of the skin may occur when this medication is first||
0696|043|S|applied to the skin. These effects should disappear in a few days||
0696|044|S|as your body adjusts to the medication. If any of these effects||
0696|045|S|last or get worse, notify your doctor or pharmacist promptly.||
0696|046|S|   Remember that this medication has been prescribed because your||
0696|047|S|doctor has judged that the benefit to you is greater than the||
0696|048|S|risk of side effects. Many people using this medication do not||
0696|049|S|have serious side effects.||
0696|050|S|   Tell your doctor right away if you have any serious side||
0696|051|S|effects, including: stretch marks, skin thinning/discoloration,||
0696|052|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0696|053|S|(folliculitis).||
0696|054|S|   Skin infections can become worse when using this medication.||
0696|055|S|Notify your doctor promptly if redness, swelling, or irritation||
0696|056|S|does not improve.||
0696|057|S|   Rarely, it is possible this medication will be absorbed from||
0696|058|S|the skin into the bloodstream. This can lead to side effects of||
0696|059|S|too much corticosteroid. These side effects are more likely in||
0696|060|S|children, and in people who use this medication for a long time||
0696|061|S|or over large areas of the skin. Tell your doctor right away if||
0696|062|S|any of the following side effects occur: unusual/extreme||
0696|063|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0696|064|S|thirst/urination, vision problems.||
0696|065|S|   A very serious allergic reaction to this drug is rare.||
0696|066|S|However, get medical help right away if you notice any symptoms||
0696|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0696|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0696|069|S|breathing.||
0696|070|S|   This is not a complete list of possible side effects. If you||
0696|071|S|notice other effects not listed above, contact your doctor or||
0696|072|S|pharmacist.||
0696|073|S|   In the US -||
0696|074|S|   Call your doctor for medical advice about side effects. You||
0696|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0696|076|S|www.fda.gov/medwatch.||
0696|077|S|   In Canada - Call your doctor for medical advice about side||
0696|078|S|effects. You may report side effects to Health Canada at||
0696|079|S|1-866-234-2345.||
0696|080|B|||
0696|081|P|PRECAUTIONS:  Before using alclometasone, tell your doctor or||
0696|082|P|pharmacist if you are allergic to it; or to other corticosteroids||
0696|083|P|(such as hydrocortisone, prednisone); or if you have any other||
0696|084|P|allergies. This product may contain inactive ingredients, which||
0696|085|P|can cause allergic reactions or other problems. Talk to your||
0696|086|P|pharmacist for more details.||
0696|087|P|   Before using this medication, tell your doctor or pharmacist||
0696|088|P|your medical history, especially of: poor blood circulation,||
0696|089|P|diabetes, immune system problems.||
0696|090|P|   Do not use if there is an infection or sore in the area to be||
0696|091|P|treated.||
0696|092|P|   Rarely, using corticosteroid medications for a long time or||
0696|093|P|over large areas of skin can make it more difficult for your body||
0696|094|P|to respond to physical stress. Before having surgery or emergency||
0696|095|P|treatment, or if you get a serious illness/injury, tell your||
0696|096|P|doctor or dentist that you are using this medication or have used||
0696|097|P|this medication within the past few months.||
0696|098|P|   Though it is unlikely, this medication may temporarily slow||
0696|099|P|down a child's growth if used for a long time. See the doctor||
0696|100|P|regularly so your child's height can be checked.||
0696|101|P|   During pregnancy, this medication should be used only when||
0696|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0696|103|P|   It is unknown if this drug passes into breast milk when||
0696|104|P|applied to the skin. Similar medications pass into breast milk||
0696|105|P|when taken by mouth. Consult your doctor before breastfeeding.||
0696|106|B|||
0696|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0696|108|I|medications work or increase your risk for serious side effects.||
0696|109|I|This document does not contain all possible drug interactions.||
0696|110|I|Keep a list of all the products you use (including||
0696|111|I|prescription/nonprescription drugs and herbal products) and share||
0696|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
0696|113|I|the dosage of any medicines without your doctor's approval.||
0696|114|B|||
0696|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0696|116|O|has overdosed and has serious symptoms such as passing out or||
0696|117|O|trouble breathing, call 911. Otherwise, call a poison control||
0696|118|O|center right away. US residents can call 1-800-222-1222. Canada||
0696|119|O|residents can call 1-844-764-7669.||
0696|120|B|||
0696|121|N|NOTES:  Do not share this medication with others.||
0696|122|N|   This medication has been prescribed for your current condition||
0696|123|N|only. Do not use it later for other skin problems unless told to||
0696|124|N|do so by your doctor. A different medication may be necessary in||
0696|125|N|those cases.||
0696|126|B|||
0696|127|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0696|128|D|If it is near the time of the next dose, skip the missed dose.||
0696|129|D|Use your next dose at the regular time. Do not double the dose to||
0696|130|D|catch up.||
0696|131|B|||
0696|132|R|STORAGE:  Store in the refrigerator or at room temperature. Keep||
0696|133|R|all medications away from children and pets.||
0696|134|R|   Do not flush medications down the toilet or pour them into a||
0696|135|R|drain unless instructed to do so. Properly discard this product||
0696|136|R|when it is expired or no longer needed. Consult your pharmacist||
0696|137|R|or local waste disposal company.||
0696|138|B|||
0696|139|A|Information last revised October 2024.||
0696|140|A|Copyright(c) 2025 First Databank, Inc.||
0696|141|B|||
0698|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0698|002|Z|does NOT have all possible information about this product. This||
0698|003|Z|information does not assure that this product is safe, effective,||
0698|004|Z|or appropriate for you. This information is not individual||
0698|005|Z|medical advice and does not substitute for the advice of your||
0698|006|Z|health care professional. Always ask your health care||
0698|007|Z|professional for complete information about this product and your||
0698|008|Z|specific health needs.||
0698|009|B|||
0698|010|T|MICONAZOLE NITRATE - VAGINAL||
0698|011|F|(mye-KON-a-zole NYE-trate)||
0698|012|B|||
0698|013|C|COMMON BRAND NAME(S): Monistat||
0698|014|B|||
0698|015|U|USES:  This medication is used to treat vaginal yeast infections.||
0698|016|U|Miconazole reduces vaginal burning, itching, and discharge that||
0698|017|U|may occur with this condition. This medication is an azole||
0698|018|U|antifungal. It works by stopping the growth of yeast (fungus)||
0698|019|U|that causes the infection. The vaginal product comes in 2 forms||
0698|020|U|(a vaginal cream or tablet). Some products also come with a skin||
0698|021|U|cream to be applied to the area around the outside of the vagina.||
0698|022|U|   Ask your doctor before using this medication for||
0698|023|U|self-treatment if this is your first vaginal infection. This||
0698|024|U|medication only works for vaginal fungal infections. You may have||
0698|025|U|a different type of infection (such as bacterial vaginosis) and||
0698|026|U|may need a different medication.||
0698|027|U|   If you have fever, chills, flu-like symptoms,||
0698|028|U|stomach/abdominal pain, or a bad-smelling vaginal discharge, do||
0698|029|U|not use this medication. Contact your doctor right away because||
0698|030|U|these may be signs of a more serious infection.||
0698|031|B|||
0698|032|H|HOW TO USE:  If you are using the over-the-counter product to||
0698|033|H|self-treat, read all directions on the product package before||
0698|034|H|using this medication. If you have any questions, consult your||
0698|035|H|pharmacist. If your doctor has prescribed this medication, use it||
0698|036|H|as directed.||
0698|037|H|   Read the Patient Information Leaflet available from your||
0698|038|H|pharmacist. Consult your doctor or pharmacist if you have any||
0698|039|H|questions.||
0698|040|H|   This product is for vaginal use only. Wash your hands before||
0698|041|H|and after use. Avoid contact of this product with your eyes. If||
0698|042|H|it gets into your eyes, wash them right away with plenty of||
0698|043|H|water. Call your doctor if eye irritation lasts.||
0698|044|H|   Dosage is based on your medical condition and response to||
0698|045|H|treatment. Use the medication usually once daily at bedtime for 1||
0698|046|H|to 7 nights depending on the product used, or as directed by your||
0698|047|H|doctor. If you are using the single dose tablet, it may be used||
0698|048|H|during the daytime or at bedtime.||
0698|049|H|   If using the vaginal cream, follow the package instructions on||
0698|050|H|how to fill/use the applicator with the cream. Lie on your back||
0698|051|H|with your knees toward your chest. Insert one applicator filled||
0698|052|H|with cream into the vagina as far as it will comfortably go.||
0698|053|H|Slowly press the plunger of the applicator in to apply the cream.||
0698|054|H|Make sure to insert the correct cream for use inside the vagina,||
0698|055|H|not the skin cream for use on the outer genital area (vulva).||
0698|056|H|   If using the vaginal tablet, you may use either the applicator||
0698|057|H|or your finger to insert the tablet. Unwrap the tablet before||
0698|058|H|use. Follow the package instructions on how to fill the||
0698|059|H|applicator with the vaginal tablet. Lie on your back with your||
0698|060|H|knees toward your chest. Insert the tablet or the applicator into||
0698|061|H|the vagina as far as it will comfortably go. Slowly press the||
0698|062|H|plunger of the applicator to release the tablet.||
0698|063|H|   If you have itching/burning around the outside of the vagina||
0698|064|H|(vulva), apply the skin cream to that area usually twice a day||
0698|065|H|for no more than 7 days. If you are using a product with only the||
0698|066|H|vaginal cream, you may apply a small amount of the vaginal cream||
0698|067|H|to the area.||
0698|068|H|   Continue to use this medication every day for the full time||
0698|069|H|prescribed, even if symptoms disappear after a few days or if||
0698|070|H|your menstrual period starts. Stopping the medication too soon||
0698|071|H|may allow the yeast infection to return.||
0698|072|H|   Do not use tampons, douches, spermicides or other vaginal||
0698|073|H|products while using this medication. Unscented sanitary napkins||
0698|074|H|may be used for your menstrual period or to protect your clothing||
0698|075|H|from leakage of the medication.||
0698|076|H|   Tell your doctor if your condition does not get better after 3||
0698|077|H|days or lasts more than 7 days, or if your infection returns||
0698|078|H|within 2 months. You may need a different or additional||
0698|079|H|medication to treat your condition.||
0698|080|B|||
0698|081|S|SIDE EFFECTS:  See also Uses section.||
0698|082|S|   Headache, vaginal/urethral burning/itching/pain, or lower||
0698|083|S|abdominal cramps may occur. If any of these effects last or get||
0698|084|S|worse, notify your doctor or pharmacist promptly.||
0698|085|S|   If your doctor has directed you to use this medication,||
0698|086|S|remember that your doctor has judged that the benefit to you is||
0698|087|S|greater than the risk of side effects. Many people using this||
0698|088|S|medication do not have serious side effects.||
0698|089|S|   A very serious allergic reaction to this drug is rare.||
0698|090|S|However, get medical help right away if you notice any symptoms||
0698|091|S|of a serious allergic reaction, including: rash, itching/swelling||
0698|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0698|093|S|breathing.||
0698|094|S|   This is not a complete list of possible side effects. If you||
0698|095|S|notice other effects not listed above, contact your doctor or||
0698|096|S|pharmacist.||
0698|097|S|   In the US -||
0698|098|S|   Call your doctor for medical advice about side effects. You||
0698|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0698|100|S|www.fda.gov/medwatch.||
0698|101|S|   In Canada - Call your doctor for medical advice about side||
0698|102|S|effects. You may report side effects to Health Canada at||
0698|103|S|1-866-234-2345.||
0698|104|B|||
0698|105|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0698|106|P|pharmacist if you are allergic to it; or to other azole||
0698|107|P|antifungal agents (such as terconazole, fluconazole); or if you||
0698|108|P|have any other allergies. This product may contain inactive||
0698|109|P|ingredients, which can cause allergic reactions or other||
0698|110|P|problems. Talk to your pharmacist for more details.||
0698|111|P|   If you have any of the following health problems, consult your||
0698|112|P|doctor or pharmacist before using this medication: diabetes,||
0698|113|P|immune system problems (such as HIV-AIDS), frequent vaginal yeast||
0698|114|P|infections (more than 3 in 6 months or 4 in 1 year).||
0698|115|P|   Before having surgery, tell your doctor or dentist about all||
0698|116|P|the products you use (including prescription drugs,||
0698|117|P|nonprescription drugs, and herbal products).||
0698|118|P|   Ask your doctor whether you can have sexual intercourse while||
0698|119|P|using this product. This product may weaken rubber products (such||
0698|120|P|as latex condoms, diaphragms, cervical caps) and lead to failure.||
0698|121|P|This can result in pregnancy. Do not use these products during||
0698|122|P|treatment with this medication and for 3 days after treatment is||
0698|123|P|over. Consult your doctor about other forms of barrier||
0698|124|P|protection/birth control (such as polyurethane condoms) during||
0698|125|P|this time.||
0698|126|P|   Do not use this medication for self-treatment if you are||
0698|127|P|pregnant. During pregnancy, this medication should be used only||
0698|128|P|when clearly needed. If you are pregnant, follow your doctor's||
0698|129|P|instructions on how to use the applicator to insert this||
0698|130|P|medication. Discuss the risks and benefits with your doctor.||
0698|131|P|   It is unknown if this drug passes into breast milk. Consult||
0698|132|P|your doctor before breastfeeding.||
0698|133|B|||
0698|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0698|135|I|medications work or increase your risk for serious side effects.||
0698|136|I|This document does not contain all possible drug interactions.||
0698|137|I|Keep a list of all the products you use (including||
0698|138|I|prescription/nonprescription drugs and herbal products) and share||
0698|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
0698|140|I|the dosage of any medicines without your doctor's approval.||
0698|141|I|   A product that may interact with this drug is: warfarin.||
0698|142|B|||
0698|143|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0698|144|O|has overdosed and has serious symptoms such as passing out or||
0698|145|O|trouble breathing, call 911. Otherwise, call a poison control||
0698|146|O|center right away. US residents can call 1-800-222-1222. Canada||
0698|147|O|residents can call 1-844-764-7669.||
0698|148|B|||
0698|149|N|NOTES:  Do not share this medication with others.||
0698|150|N|   To help prevent vaginal yeast infections, dry the genital area||
0698|151|N|thoroughly after showering, bathing, or swimming. Avoid wearing||
0698|152|N|tight jeans, nylon underwear, pantyhose, a wet bathing suit, or||
0698|153|N|damp/sweaty exercise clothes for long periods. Wear cotton||
0698|154|N|underwear, and change your underwear daily.||
0698|155|N|   If your sexual partner experiences symptoms, they should||
0698|156|N|contact their doctor right away.||
0698|157|B|||
0698|158|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0698|159|D|If it is near the time of the next dose, skip the missed dose.||
0698|160|D|Use your next dose at the regular time. Do not double the dose to||
0698|161|D|catch up.||
0698|162|B|||
0698|163|R|STORAGE:  Store at room temperature. Keep all medications away||
0698|164|R|from children and pets.||
0698|165|R|   Do not flush medications down the toilet or pour them into a||
0698|166|R|drain unless instructed to do so. Properly discard this product||
0698|167|R|when it is expired or no longer needed. Consult your pharmacist||
0698|168|R|or local waste disposal company.||
0698|169|B|||
0698|170|A|Information last revised November 2024.||
0698|171|A|Copyright(c) 2025 First Databank, Inc.||
0698|172|B|||
0699|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0699|002|Z|does NOT have all possible information about this product. This||
0699|003|Z|information does not assure that this product is safe, effective,||
0699|004|Z|or appropriate for you. This information is not individual||
0699|005|Z|medical advice and does not substitute for the advice of your||
0699|006|Z|health care professional. Always ask your health care||
0699|007|Z|professional for complete information about this product and your||
0699|008|Z|specific health needs.||
0699|009|B|||
0699|010|T|NEPAFENAC SUSPENSION - OPHTHALMIC||
0699|011|F|(ne-PA-fen-ak)||
0699|012|B|||
0699|013|C|COMMON BRAND NAME(S): Ilevro, Nevanac||
0699|014|B|||
0699|015|U|USES:  This medication is used to relieve eye pain, irritation,||
0699|016|U|and redness following cataract eye surgery. Nepafenac belongs to||
0699|017|U|a class of drugs known as nonsteroidal anti-inflammatory drugs||
0699|018|U|(NSAIDs). It works by blocking certain natural substances||
0699|019|U|(prostaglandins) in your body that cause pain and swelling.||
0699|020|B|||
0699|021|H|HOW TO USE:  Use this medication in the operated eye(s) as||
0699|022|H|directed by your doctor. The instructions for use depend on the||
0699|023|H|strength of the eye drops prescribed. This medication is usually||
0699|024|H|started 1 day before surgery, and continued on the day of surgery||
0699|025|H|and for 2 weeks after surgery. Follow your doctor's instructions||
0699|026|H|carefully.||
0699|027|H|   To apply eye drops, wash your hands first. Shake the bottle||
0699|028|H|well before each dose. To avoid contamination, do not touch the||
0699|029|H|dropper tip or let it touch your eye or any other surface.||
0699|030|H|   This medication should not be used while wearing contact||
0699|031|H|lenses. Consult your doctor or pharmacist for details.||
0699|032|H|   Tilt your head back, look upward, and gently pull down the||
0699|033|H|lower eyelid to make a pouch. Hold the dropper directly over your||
0699|034|H|eye and place one drop into the pouch. Look downward and gently||
0699|035|H|close your eyes for 1 to 2 minutes. Try not to blink and do not||
0699|036|H|rub your eye. Repeat these steps for your other eye if so||
0699|037|H|directed.||
0699|038|H|   Do not rinse the dropper. Replace the dropper cap after each||
0699|039|H|use.||
0699|040|H|   If you are using another kind of eye medication (such as drops||
0699|041|H|or ointments), wait at least 5 minutes before applying other||
0699|042|H|medications. Use eye drops before eye ointments to allow the eye||
0699|043|H|drops to enter the eye.||
0699|044|H|   Wait several minutes for your vision to clear before driving||
0699|045|H|or operating machinery.||
0699|046|H|   This medication is usually used for up to 14 days after eye||
0699|047|H|surgery or as directed by your doctor. Do not start using this||
0699|048|H|medication early, use it more often than prescribed, or keep||
0699|049|H|using it for longer than directed by your doctor. Prolonged use||
0699|050|H|of nepafenac eye drops (more than 2 weeks) may increase the risk||
0699|051|H|of very serious side effects of the eye.||
0699|052|H|   Tell your doctor if your condition lasts or gets worse.||
0699|053|B|||
0699|054|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
0699|055|S|eyes for 1-2 minutes when applied. Eye redness and headache may||
0699|056|S|also occur. If any of these effects last or get worse, notify||
0699|057|S|your doctor or pharmacist promptly.||
0699|058|S|   Remember that this medication has been prescribed because your||
0699|059|S|doctor has judged that the benefit to you is greater than the||
0699|060|S|risk of side effects. Many people using this medication do not||
0699|061|S|have serious side effects.||
0699|062|S|   Tell your doctor right away if you have any serious side||
0699|063|S|effects, including: eye swelling/pain, eye discharge/extreme||
0699|064|S|watering, vision changes.||
0699|065|S|   A very serious allergic reaction to this drug is rare.||
0699|066|S|However, get medical help right away if you notice any symptoms||
0699|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0699|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0699|069|S|breathing.||
0699|070|S|   This is not a complete list of possible side effects. If you||
0699|071|S|notice other effects not listed above, contact your doctor or||
0699|072|S|pharmacist.||
0699|073|S|   In the US -||
0699|074|S|   Call your doctor for medical advice about side effects. You||
0699|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0699|076|S|www.fda.gov/medwatch.||
0699|077|S|   In Canada - Call your doctor for medical advice about side||
0699|078|S|effects. You may report side effects to Health Canada at||
0699|079|S|1-866-234-2345.||
0699|080|B|||
0699|081|P|PRECAUTIONS:  Before using nepafenac, tell your doctor or||
0699|082|P|pharmacist if you are allergic to it; or to aspirin, or to other||
0699|083|P|NSAIDs (such as ibuprofen, celecoxib); or if you have any other||
0699|084|P|allergies. This product may contain inactive ingredients (such as||
0699|085|P|preservatives like benzalkonium chloride), which can cause||
0699|086|P|allergic reactions or other problems. Talk to your pharmacist for||
0699|087|P|more details.||
0699|088|P|   Before using this medication, tell your doctor or pharmacist||
0699|089|P|your medical history, especially of: asthma (including a history||
0699|090|P|of worsening breathing after taking aspirin or other NSAIDs),||
0699|091|P|bleeding problems, previous eye surgery, other eye problems (such||
0699|092|P|as dry eye syndrome, corneal problems), diabetes, rheumatoid||
0699|093|P|arthritis, nasal polyps.||
0699|094|P|   After you apply this drug, your vision may become temporarily||
0699|095|P|blurred or unstable. Do not drive, use machinery, or do anything||
0699|096|P|that needs clear vision until you can do it safely.||
0699|097|P|   During pregnancy, this medication should be used only when||
0699|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
0699|099|P|   It is unknown if this drug passes into breast milk. Consult||
0699|100|P|your doctor before breastfeeding.||
0699|101|B|||
0699|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0699|103|I|medications work or increase your risk for serious side effects.||
0699|104|I|This document does not contain all possible drug interactions.||
0699|105|I|Keep a list of all the products you use (including||
0699|106|I|prescription/nonprescription drugs and herbal products) and share||
0699|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
0699|108|I|the dosage of any medicines without your doctor's approval.||
0699|109|I|   Some products that may interact with this drug are:||
0699|110|I|anti-platelet medications (such as clopidogrel), "blood thinners"||
0699|111|I|(such as warfarin), corticosteroid drugs (such as prednisone),||
0699|112|I|other eye medications (such as corticosteroid eye drops).||
0699|113|I|   Check all prescription and nonprescription medicine labels||
0699|114|I|carefully since many medications contain pain relievers/fever||
0699|115|I|reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) which,||
0699|116|I|if used together with nepafenac, may increase your risk for||
0699|117|I|bleeding. However, if your doctor has told you to take low-dose||
0699|118|I|aspirin to prevent heart attack or stroke (usually 81-162||
0699|119|I|milligrams a day), you should keep taking the aspirin unless your||
0699|120|I|doctor tells you not to. Ask your doctor or pharmacist for more||
0699|121|I|details.||
0699|122|B|||
0699|123|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0699|124|O|has overdosed and has serious symptoms such as passing out or||
0699|125|O|trouble breathing, call 911. Otherwise, call a poison control||
0699|126|O|center right away. US residents can call 1-800-222-1222. Canada||
0699|127|O|residents can call 1-844-764-7669.||
0699|128|B|||
0699|129|N|NOTES:  Do not share this medication with others.||
0699|130|N|   This medication has been prescribed for your current condition||
0699|131|N|only. Do not use it later for another eye condition unless told||
0699|132|N|to do so by your doctor. A different medication may be necessary||
0699|133|N|in that case.||
0699|134|B|||
0699|135|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0699|136|D|If it is near the time of the next dose, skip the missed dose.||
0699|137|D|Use your next dose at the regular time. Do not double the dose to||
0699|138|D|catch up.||
0699|139|B|||
0699|140|R|STORAGE:  Store in the refrigerator or at room temperature away||
0699|141|R|from light. Do not freeze. Keep all medications away from||
0699|142|R|children and pets.||
0699|143|R|   Do not flush medications down the toilet or pour them into a||
0699|144|R|drain unless instructed to do so. Properly discard this product||
0699|145|R|when it is expired or no longer needed. Consult your pharmacist||
0699|146|R|or local waste disposal company.||
0699|147|B|||
0699|148|A|Information last revised May 2024.||
0699|149|A|Copyright(c) 2025 First Databank, Inc.||
0699|150|B|||
0702|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0702|002|Z|does NOT have all possible information about this product. This||
0702|003|Z|information does not assure that this product is safe, effective,||
0702|004|Z|or appropriate for you. This information is not individual||
0702|005|Z|medical advice and does not substitute for the advice of your||
0702|006|Z|health care professional. Always ask your health care||
0702|007|Z|professional for complete information about this product and your||
0702|008|Z|specific health needs.||
0702|009|B|||
0702|010|T|LIDOCAINE/HYDROCORTISONE - RECTAL||
0702|011|F|(LYE-doe-kane/hi-dro-KOR-tih-sown)||
0702|012|B|||
0702|013|C|COMMON BRAND NAME(S): Ana-Lex, Anamantle HC||
0702|014|B|||
0702|015|U|USES:  This combination medication is used to treat minor pain,||
0702|016|U|itching, swelling, and discomfort caused by hemorrhoids and other||
0702|017|U|problems of the anal area (such as anal fissures, itching). This||
0702|018|U|medication contains lidocaine, an anesthetic that works by||
0702|019|U|temporarily numbing the area. This product also contains||
0702|020|U|hydrocortisone, a corticosteroid that reduces redness, itching,||
0702|021|U|and swelling.||
0702|022|B|||
0702|023|H|HOW TO USE:  Follow all instructions in the product package for||
0702|024|H|using the applicator tip/cap/nozzle. Before use, clean the||
0702|025|H|affected area with mild soap and water, rinse well, and pat dry.||
0702|026|H|Your product may come with single-use wipes to cleanse the area||
0702|027|H|instead of using soap and water. Gently insert the applicator tip||
0702|028|H|just 1/2 to 1 inch (1.5 to 2.5 centimeters) inside the anus and||
0702|029|H|apply the product in and around the anal opening as directed in||
0702|030|H|the package instructions or by your doctor. When using a||
0702|031|H|single-use tube and applicator, discard after use. Do not reuse.||
0702|032|H|Do not insert any part of the container into the anus, and do not||
0702|033|H|insert the applicator tip/nozzle more than one-half to 1 inch||
0702|034|H|(2.5 centimeter) inside the anus. Do not use your finger to apply||
0702|035|H|the medication into the anus.||
0702|036|H|   To apply the product to the outside of the anus only, apply a||
0702|037|H|small amount to the affected area and rub in gently.||
0702|038|H|   Do not cover the area with plastic or waterproof bandages||
0702|039|H|unless directed to do so by your doctor. Covering the treated||
0702|040|H|area may increase the absorption of the medication through the||
0702|041|H|skin. This may improve how well the drug works, but it may also||
0702|042|H|increase the risk of side effects.||
0702|043|H|   Wash hands immediately after use. Avoid getting the product in||
0702|044|H|your eyes, nose, ears or mouth. If the medication gets in these||
0702|045|H|areas, rinse the area immediately with clean water.||
0702|046|H|   Use this product as directed by your doctor, usually twice||
0702|047|H|daily or after each bowel movement. The dosage is based on your||
0702|048|H|medical condition and response to treatment. Use this medication||
0702|049|H|regularly in order to get the most benefit from it. To help you||
0702|050|H|remember, use it at the same times each day.||
0702|051|H|   Do not use more of this product, use it more often, or keep||
0702|052|H|using it longer than prescribed by your doctor. If you have been||
0702|053|H|using this medication for a long time or in high doses, do not||
0702|054|H|suddenly stop using it without your doctor's approval. Some||
0702|055|H|conditions may become worse when this drug is suddenly stopped.||
0702|056|H|Your dose may need to be gradually decreased.||
0702|057|H|   Tell your doctor if your condition does not get better or if||
0702|058|H|it gets worse after 1 to 2 weeks.||
0702|059|B|||
0702|060|S|SIDE EFFECTS:  Redness, burning, or itching at the application||
0702|061|S|site may occur. If any of these effects last or get worse,||
0702|062|S|contact your doctor or pharmacist promptly.||
0702|063|S|   Remember that this medication has been prescribed because your||
0702|064|S|doctor has judged that the benefit to you is greater than the||
0702|065|S|risk of side effects. Many people using this medication do not||
0702|066|S|have serious side effects.||
0702|067|S|   Tell your doctor right away if you have any serious side||
0702|068|S|effects, including: rectal bleeding, change in skin appearance||
0702|069|S|(such as color, thickness), skin redness/tenderness/pus, signs of||
0702|070|S|infection (such as sore throat that doesn't go away, fever,||
0702|071|S|chills).||
0702|072|S|   Rarely, it is possible this medication will be absorbed into||
0702|073|S|the bloodstream. This can lead to side effects of too much||
0702|074|S|corticosteroid. These side effects are more likely in children||
0702|075|S|and people who use this medication for a long time. Tell your||
0702|076|S|doctor right away if any of the following side effects occur:||
0702|077|S|unusual/extreme tiredness, weight loss, headache, swelling||
0702|078|S|ankles/feet, increased thirst/urination, vision problems.||
0702|079|S|   Get medical help right away if you have any very serious side||
0702|080|S|effects, including: slow/shallow breathing, seizures,||
0702|081|S|pale/bluish/gray skin, shortness of breath, fast/slow/irregular||
0702|082|S|heartbeat.||
0702|083|S|   A very serious allergic reaction to this drug is rare.||
0702|084|S|However, get medical help right away if you notice any symptoms||
0702|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0702|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0702|087|S|breathing.||
0702|088|S|   This is not a complete list of possible side effects. If you||
0702|089|S|notice other effects not listed above, contact your doctor or||
0702|090|S|pharmacist.||
0702|091|S|   In the US -||
0702|092|S|   Call your doctor for medical advice about side effects. You||
0702|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0702|094|S|www.fda.gov/medwatch.||
0702|095|S|   In Canada - Call your doctor for medical advice about side||
0702|096|S|effects. You may report side effects to Health Canada at||
0702|097|S|1-866-234-2345.||
0702|098|B|||
0702|099|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0702|100|P|pharmacist if you are allergic to lidocaine; or to other amide||
0702|101|P|anesthetics (such as bupivacaine, prilocaine); or to||
0702|102|P|hydrocortisone; or if you have any other allergies. This product||
0702|103|P|may contain inactive ingredients, which can cause allergic||
0702|104|P|reactions or other problems. Talk to your pharmacist for more||
0702|105|P|details.||
0702|106|P|   Before using this medication, tell your doctor or pharmacist||
0702|107|P|your medical history, especially of: diabetes, eye problems,||
0702|108|P|current/recent infections (such as tuberculosis, chickenpox,||
0702|109|P|herpes, fungal infection), rectal sores/infections, liver||
0702|110|P|disease, stomach/intestinal problems, a certain blood disorder||
0702|111|P|(methemoglobinemia).||
0702|112|P|   Rarely, using corticosteroid medications for a long time can||
0702|113|P|make it more difficult for your body to respond to physical||
0702|114|P|stress. Before having surgery or emergency treatment, or if you||
0702|115|P|get a serious illness/injury, tell your doctor or dentist that||
0702|116|P|you are using this medication or have used this medication within||
0702|117|P|the past few months.||
0702|118|P|   Though it is unlikely, this medication may temporarily slow||
0702|119|P|down a child's growth if used for a long time. See the doctor||
0702|120|P|regularly so your child's height can be checked.||
0702|121|P|   During pregnancy, this medication should be used only when||
0702|122|P|clearly needed. It should not be used for long periods of time or||
0702|123|P|in large amounts. Discuss the risks and benefits with your||
0702|124|P|doctor.||
0702|125|P|   Lidocaine passes into breast milk. It is unknown if||
0702|126|P|hydrocortisone passes into breast milk. Consult your doctor||
0702|127|P|before breastfeeding.||
0702|128|B|||
0702|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0702|130|I|medications work or increase your risk for serious side effects.||
0702|131|I|This document does not contain all possible drug interactions.||
0702|132|I|Keep a list of all the products you use (including||
0702|133|I|prescription/nonprescription drugs and herbal products) and share||
0702|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
0702|135|I|the dosage of any medicines without your doctor's approval.||
0702|136|I|   A product that may interact with this drug is: desmopressin.||
0702|137|B|||
0702|138|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0702|139|O|has overdosed and has serious symptoms such as passing out or||
0702|140|O|trouble breathing, call 911. Otherwise, call a poison control||
0702|141|O|center right away. US residents can call 1-800-222-1222. Canada||
0702|142|O|residents can call 1-844-764-7669.||
0702|143|B|||
0702|144|N|NOTES:  Lab and/or medical tests (such as cortisol levels) may be||
0702|145|N|done while you are using this medication. Keep all medical and||
0702|146|N|lab appointments. Consult your doctor for more details.||
0702|147|N|   This medication has been prescribed for your current condition||
0702|148|N|only. Do not use it later for another condition unless told to do||
0702|149|N|so by your doctor. A different medication may be necessary in||
0702|150|N|that case.||
0702|151|B|||
0702|152|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
0702|153|D|unless it is almost time for the next dose. In that case, skip||
0702|154|D|the missed dose. Use your next dose at the regular time. Do not||
0702|155|D|double the dose to catch up.||
0702|156|B|||
0702|157|R|STORAGE:  Store at room temperature. Do not refrigerate or||
0702|158|R|freeze. Keep all medications away from children and pets.||
0702|159|R|   Do not flush medications down the toilet or pour them into a||
0702|160|R|drain unless instructed to do so. Properly discard this product||
0702|161|R|when it is expired or no longer needed. Consult your pharmacist||
0702|162|R|or local waste disposal company.||
0702|163|B|||
0702|164|A|Information last revised April 2025.||
0702|165|A|Copyright(c) 2025 First Databank, Inc.||
0702|166|B|||
0703|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0703|002|Z|does NOT have all possible information about this product. This||
0703|003|Z|information does not assure that this product is safe, effective,||
0703|004|Z|or appropriate for you. This information is not individual||
0703|005|Z|medical advice and does not substitute for the advice of your||
0703|006|Z|health care professional. Always ask your health care||
0703|007|Z|professional for complete information about this product and your||
0703|008|Z|specific health needs.||
0703|009|B|||
0703|010|T|OXYCODONE/ASPIRIN - ORAL||
0703|011|F|(ox-ee-KOH-doan/AS-pir-in)||
0703|012|B|||
0703|013|C|COMMON BRAND NAME(S): Endodan, Percodan||
0703|014|B|||
0703|015|W|WARNING:  Oxycodone/aspirin has a risk for abuse and addiction,||
0703|016|W|which can lead to overdose and death. Oxycodone/aspirin may also||
0703|017|W|cause severe, possibly fatal, breathing problems. To lower your||
0703|018|W|risk, your doctor should have you take the smallest dose of||
0703|019|W|oxycodone/aspirin that works, and take it for the shortest||
0703|020|W|possible time. See also How to Use section for more information||
0703|021|W|about addiction.||
0703|022|W|   Ask your doctor or pharmacist if you should have medication||
0703|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0703|024|W|Teach your family or household members about the signs of an||
0703|025|W|opioid overdose and how to treat it.||
0703|026|W|   The risk for severe breathing problems is higher when you||
0703|027|W|start this medication and after a dose increase, or if you take||
0703|028|W|the wrong dose/strength. Taking this medication with alcohol or||
0703|029|W|other drugs that can cause drowsiness or breathing problems may||
0703|030|W|cause very serious side effects, including death. Also, other||
0703|031|W|medications can affect the removal of oxycodone/aspirin from your||
0703|032|W|body, which may affect how oxycodone/aspirin works. Be sure you||
0703|033|W|know how to take oxycodone/aspirin and what other drugs you||
0703|034|W|should avoid taking with it. See also Drug Interactions section.||
0703|035|W|Get medical help right away if any of these very serious side||
0703|036|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
0703|037|W|severe drowsiness/dizziness, difficulty waking up.||
0703|038|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0703|039|W|or abuse. If someone accidentally swallows this drug, get medical||
0703|040|W|help right away.||
0703|041|B|||
0703|042|U|USES:  This medication is used to relieve moderate to moderately||
0703|043|U|severe pain. It contains 2 pain relievers: oxycodone and aspirin.||
0703|044|U|Oxycodone is an opioid pain reliever that acts on certain parts||
0703|045|U|of the brain to relieve pain. Aspirin is known as a salicylate||
0703|046|U|and a nonsteroidal anti-inflammatory drug (NSAID). It works by||
0703|047|U|blocking a certain natural substance in your body to reduce pain||
0703|048|U|and swelling, making you more comfortable and more able to||
0703|049|U|function normally.||
0703|050|B|||
0703|051|H|HOW TO USE:  Read the Medication Guide provided by your||
0703|052|H|pharmacist before you start taking oxycodone/aspirin and each||
0703|053|H|time you get a refill. If you have any questions, ask your doctor||
0703|054|H|or pharmacist.||
0703|055|H|   Take this medication by mouth as directed by your doctor. Take||
0703|056|H|it with a full glass (8 ounces or 240 milliliters) of water. Do||
0703|057|H|not lie down for at least 10 minutes after taking a dose. To help||
0703|058|H|prevent stomach upset, take it with food or milk. If you have||
0703|059|H|nausea, ask your doctor or pharmacist about ways to decrease||
0703|060|H|nausea (such as lying down for 1 to 2 hours with as little head||
0703|061|H|movement as possible). Follow your doctor's instructions exactly.||
0703|062|H|Your doctor may instruct you to take this medication only as||
0703|063|H|needed for shorter periods of pain (such as after surgery) or on||
0703|064|H|a regular schedule for ongoing pain (such as cancer pain).||
0703|065|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0703|066|H|using this medication unless your doctor or pharmacist says you||
0703|067|H|may do so safely. Grapefruit can increase the chance of side||
0703|068|H|effects with this medicine. Ask your doctor or pharmacist for||
0703|069|H|more details.||
0703|070|H|   If you are taking this medication as needed, remember to take||
0703|071|H|it as the first signs of pain occur. If you wait until the pain||
0703|072|H|has worsened, the medication may not work as well.||
0703|073|H|   The dosage is based on your medical condition, use of other||
0703|074|H|pain medications, and response to treatment. Do not increase your||
0703|075|H|dose without consulting your doctor or pharmacist. Do not take||
0703|076|H|more than 4 grams (4000 milligrams) of aspirin in 24 hours. Use||
0703|077|H|the smallest effective dose.||
0703|078|H|   If you have ongoing pain (such as due to cancer), your doctor||
0703|079|H|may direct you to also take long-acting opioid medications. In||
0703|080|H|that case, this medication might be used for sudden||
0703|081|H|(breakthrough) pain only as needed. Other pain relievers (such as||
0703|082|H|acetaminophen, ibuprofen) may also be prescribed with this||
0703|083|H|medication. Ask your doctor or pharmacist about using oxycodone||
0703|084|H|safely with other drugs.||
0703|085|H|   Suddenly stopping this medication may cause withdrawal,||
0703|086|H|especially if you have used it for a long time or in high doses.||
0703|087|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0703|088|H|Tell your doctor or pharmacist right away if you have any||
0703|089|H|withdrawal symptoms such as restlessness, mental/mood changes||
0703|090|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0703|091|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0703|092|H|aches, or sudden changes in behavior.||
0703|093|H|   When this medication is taken for a long time, it may not work||
0703|094|H|as well. Your doctor may need to increase your dose or change||
0703|095|H|your medication. Talk with your doctor if this medication stops||
0703|096|H|working well.||
0703|097|H|   Though it helps many people, this medication may sometimes||
0703|098|H|cause addiction. This risk may be higher if you have a||
0703|099|H|mental/mood disorder or a substance use disorder (such as overuse||
0703|100|H|of or addiction to drugs/alcohol). Take this medication exactly||
0703|101|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0703|102|H|pharmacist for more details.||
0703|103|H|   Tell your doctor if your pain does not get better or if it||
0703|104|H|gets worse, or if you have any new pain.||
0703|105|B|||
0703|106|S|SIDE EFFECTS:  See also Warning section.||
0703|107|S|   Nausea, vomiting, upset stomach, constipation, dizziness,||
0703|108|S|drowsiness, headache, increased sweating, dry mouth,||
0703|109|S|lightheadedness, or weakness may occur. Some of these side||
0703|110|S|effects may decrease after you have been using this medication||
0703|111|S|for a while. If any of these effects last or get worse, tell your||
0703|112|S|doctor or pharmacist promptly.||
0703|113|S|   To reduce the risk of dizziness and lightheadedness, get up||
0703|114|S|slowly when rising from a sitting or lying position.||
0703|115|S|   To prevent constipation, eat dietary fiber, drink enough||
0703|116|S|water, and exercise. You may also need to take a laxative. Ask||
0703|117|S|your pharmacist which type of laxative is right for you.||
0703|118|S|   Remember that this medication has been prescribed because your||
0703|119|S|doctor has judged that the benefit to you is greater than the||
0703|120|S|risk of side effects. Many people using this medication do not||
0703|121|S|have serious side effects.||
0703|122|S|   Tell your doctor right away if you have any serious side||
0703|123|S|effects, including: nausea that doesn't stop, interrupted||
0703|124|S|breathing during sleep (sleep apnea), slow/fast/irregular||
0703|125|S|heartbeat, mental/mood changes (such as depression,||
0703|126|S|hallucinations, confusion), difficult/painful urination, ringing||
0703|127|S|in the ears, decreased hearing, vision changes, easy||
0703|128|S|bruising/bleeding, stomach/abdominal pain, black stools, vomit||
0703|129|S|that looks like coffee grounds, yellowing eyes/skin, dark urine,||
0703|130|S|signs of kidney problems (such as change in the amount of urine),||
0703|131|S|signs of your adrenal glands not working well (such as loss of||
0703|132|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
0703|133|S|   Get medical help right away if you have any very serious side||
0703|134|S|effects, including: slow/shallow breathing, fainting, seizures,||
0703|135|S|severe drowsiness/difficulty waking up.||
0703|136|S|   A very serious allergic reaction to this drug is rare.||
0703|137|S|However, get medical help right away if you notice any symptoms||
0703|138|S|of a serious allergic reaction, including: fever, swollen lymph||
0703|139|S|nodes, rash, itching/swelling (especially of the||
0703|140|S|face/tongue/throat), severe dizziness, trouble breathing.||
0703|141|S|   This is not a complete list of possible side effects. If you||
0703|142|S|notice other effects not listed above, contact your doctor or||
0703|143|S|pharmacist.||
0703|144|S|   In the US -||
0703|145|S|   Call your doctor for medical advice about side effects. You||
0703|146|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0703|147|S|www.fda.gov/medwatch.||
0703|148|S|   In Canada - Call your doctor for medical advice about side||
0703|149|S|effects. You may report side effects to Health Canada at||
0703|150|S|1-866-234-2345.||
0703|151|B|||
0703|152|P|PRECAUTIONS:  Before taking oxycodone with aspirin, tell your||
0703|153|P|doctor or pharmacist if you are allergic to it; or to other||
0703|154|P|opioids (such as codeine, hydrocodone, oxymorphone), salicylates||
0703|155|P|(such as salsalate), or nonsteroidal anti-inflammatory drugs||
0703|156|P|(such as ibuprofen, naproxen, celecoxib); or if you have any||
0703|157|P|other allergies. This product may contain inactive ingredients,||
0703|158|P|which can cause allergic reactions or other problems. Talk to||
0703|159|P|your pharmacist for more details.||
0703|160|P|   Before using this medication, tell your doctor or pharmacist||
0703|161|P|your medical history, especially of: intestinal/bowel disorders||
0703|162|P|(such as paralytic ileus, infectious diarrhea, colitis,||
0703|163|P|blockage), kidney disease, liver disease, bleeding/blood-clotting||
0703|164|P|disorders (such as hemophilia, vitamin K deficiency, low platelet||
0703|165|P|count), stomach problems (such as ulcers, heartburn, stomach||
0703|166|P|pain), gout, lung diseases (such as asthma, chronic obstructive||
0703|167|P|pulmonary disease-COPD), breathing problems (such as slow/shallow||
0703|168|P|breathing, sleep apnea), growths in the nose (nasal polyps), a||
0703|169|P|certain spinal problem (kyphoscoliosis), certain heart problems||
0703|170|P|(such as low blood pressure, irregular heartbeat), personal or||
0703|171|P|family history of a substance use disorder (such as overuse of or||
0703|172|P|addiction to drugs/alcohol), brain disorders (such as seizures,||
0703|173|P|head injury, tumor, increased intracranial pressure), underactive||
0703|174|P|thyroid (hypothyroidism), difficulty urinating (for example, due||
0703|175|P|to enlarged prostate or narrowed urethra), disease of the||
0703|176|P|pancreas (such as pancreatitis), mental/mood disorders (such as||
0703|177|P|toxic psychosis), gallbladder disease, adrenal gland problem||
0703|178|P|(such as Addison's disease), certain enzyme deficiencies||
0703|179|P|(pyruvate kinase or G6PD deficiency).||
0703|180|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0703|181|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0703|182|P|machinery, or do anything that needs alertness until you can do||
0703|183|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0703|184|P|are using marijuana (cannabis).||
0703|185|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0703|186|P|and tobacco, especially when combined with this medicine, may||
0703|187|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0703|188|P|smoking. Consult your doctor or pharmacist for more information.||
0703|189|P|   Before having surgery, tell your doctor or dentist about all||
0703|190|P|the products you use (including prescription drugs,||
0703|191|P|nonprescription drugs, and herbal products).||
0703|192|P|   Older adults may be more sensitive to the side effects of this||
0703|193|P|drug, especially stomach/intestinal bleeding and ulcers,||
0703|194|P|drowsiness, dizziness, slow/shallow breathing, confusion,||
0703|195|P|difficulty urinating, and constipation.||
0703|196|P|   This product contains aspirin. Children and teenagers less||
0703|197|P|than 18 years old should not take aspirin if they have||
0703|198|P|chickenpox, flu, or any undiagnosed illness, or if they have||
0703|199|P|recently received a vaccine. In these cases, taking aspirin||
0703|200|P|increases the risk of Reye's syndrome, a rare but serious||
0703|201|P|illness.||
0703|202|P|   Before using this medication, women of childbearing age should||
0703|203|P|talk with their doctor(s) about the benefits and risks. Tell your||
0703|204|P|doctor if you are pregnant or if you plan to become pregnant.||
0703|205|P|This medication may harm an unborn baby and cause problems with||
0703|206|P|normal labor/delivery. It is not recommended for use in pregnancy||
0703|207|P|from 20 weeks until delivery. If your doctor decides that you||
0703|208|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0703|209|P|you should use the lowest effective dose for the shortest||
0703|210|P|possible time. You should not use this medication after 30 weeks||
0703|211|P|of pregnancy.||
0703|212|P|   This medication passes into breast milk and may have||
0703|213|P|undesirable effects on a nursing infant. Breastfeeding is not||
0703|214|P|recommended while using this medication. Consult your doctor||
0703|215|P|before breastfeeding.||
0703|216|B|||
0703|217|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
0703|218|I|   Drug interactions may change how your medications work or||
0703|219|I|increase your risk for serious side effects. This document does||
0703|220|I|not contain all possible drug interactions. Keep a list of all||
0703|221|I|the products you use (including prescription/nonprescription||
0703|222|I|drugs and herbal products) and share it with your doctor and||
0703|223|I|pharmacist. Do not start, stop, or change the dosage of any||
0703|224|I|medicines without your doctor's approval.||
0703|225|I|   Some of the products that may interact with this drug include:||
0703|226|I|acetazolamide, certain cancer drugs (mercaptopurine,||
0703|227|I|methotrexate), certain medications for pain (opioid partial||
0703|228|I|agonists such as butorphanol, nalbuphine, pentazocine),||
0703|229|I|cimetidine, corticosteroids (such as prednisone), mifepristone,||
0703|230|I|naltrexone, samidorphan.||
0703|231|I|   This medication may increase the risk of bleeding when taken||
0703|232|I|with other drugs that also may cause bleeding. Examples include||
0703|233|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0703|234|I|dabigatran/enoxaparin/warfarin, among others.||
0703|235|I|   Before using this product, consult your doctor if you have||
0703|236|I|recently received certain live vaccines (such as varicella||
0703|237|I|vaccine, live flu vaccine).||
0703|238|I|   Other medications can affect the removal of oxycodone from||
0703|239|I|your body, which may affect how oxycodone works. Examples include||
0703|240|I|azole antifungals (such as ketoconazole), macrolide antibiotics||
0703|241|I|(such as erythromycin), HIV medications (such as tipranavir),||
0703|242|I|rifamycins (such as rifabutin, rifampin), ritonavir, certain||
0703|243|I|drugs used to treat seizures (such as carbamazepine, phenytoin),||
0703|244|I|among others.||
0703|245|I|   The risk of serious side effects (such as slow/shallow||
0703|246|I|breathing, severe drowsiness/dizziness) may be increased if this||
0703|247|I|medication is taken with other products that may also cause||
0703|248|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0703|249|I|if you are taking other products such as other opioid pain or||
0703|250|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0703|251|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0703|252|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0703|253|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0703|254|I|cetirizine, diphenhydramine).||
0703|255|I|   Check the labels on all your medicines (such as allergy or||
0703|256|I|cough-and-cold products) because they may contain ingredients||
0703|257|I|that cause drowsiness. Ask your pharmacist about using those||
0703|258|I|products safely.||
0703|259|I|   Check all prescription and nonprescription medicine labels||
0703|260|I|carefully since many medications contain pain relievers/fever||
0703|261|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
0703|262|I|naproxen). These drugs are similar to this medication and may||
0703|263|I|increase your risk of side effects if taken together. Ask your||
0703|264|I|doctor or pharmacist for more details.||
0703|265|I|   This medication may interfere with certain lab tests (such as||
0703|266|I|blood amylase and lipase levels, urine sugar tests), possibly||
0703|267|I|causing false test results. Make sure lab personnel and all your||
0703|268|I|doctors know you use this drug.||
0703|269|B|||
0703|270|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0703|271|O|as passing out or trouble breathing, give them naloxone or||
0703|272|O|nalmefene if available, then call 911. If the person is awake and||
0703|273|O|has no symptoms, call a poison control center right away. US||
0703|274|O|residents can call 1-800-222-1222. Canada residents can call||
0703|275|O|1-844-764-7669. Symptoms of overdose may include: ringing in the||
0703|276|O|ears, fever, slow/shallow breathing, severe drowsiness, slow||
0703|277|O|heartbeat, severe dizziness, pinpoint pupils, cold/clammy skin,||
0703|278|O|limp/weak muscles, coma.||
0703|279|B|||
0703|280|N|NOTES:  Do not share this medication with others. Sharing it is||
0703|281|N|against the law.||
0703|282|N|   If you are using this medication regularly or at high doses,||
0703|283|N|lab and/or medical tests (such as kidney/liver function, blood||
0703|284|N|count) may be done while you are taking this medication. Keep all||
0703|285|N|medical and lab appointments. Consult your doctor for more||
0703|286|N|details.||
0703|287|N|   This medication has been prescribed for your current condition||
0703|288|N|only. Do not use it later for another condition unless your||
0703|289|N|doctor directs you to do so. A different medication may be||
0703|290|N|necessary in that case.||
0703|291|B|||
0703|292|D|MISSED DOSE:  If you take this medication regularly and you miss||
0703|293|D|a dose, take it as soon as you remember. If it is near the time||
0703|294|D|of the next dose, skip the missed dose. Take your next dose at||
0703|295|D|the regular time. Do not double the dose to catch up.||
0703|296|B|||
0703|297|R|STORAGE:  Store at room temperature away from light and moisture.||
0703|298|R|Do not store in the bathroom. Keep all medications away from||
0703|299|R|children and pets.||
0703|300|R|   Do not flush medications down the toilet or pour them into a||
0703|301|R|drain unless instructed to do so. Properly discard this product||
0703|302|R|when it is expired or no longer needed. For more details, read||
0703|303|R|the Medication Guide, or consult your pharmacist or local waste||
0703|304|R|disposal company.||
0703|305|B|||
0703|306|A|Information last revised August 2025.||
0703|307|A|Copyright(c) 2025 First Databank, Inc.||
0703|308|B|||
0704|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0704|002|Z|does NOT have all possible information about this product. This||
0704|003|Z|information does not assure that this product is safe, effective,||
0704|004|Z|or appropriate for you. This information is not individual||
0704|005|Z|medical advice and does not substitute for the advice of your||
0704|006|Z|health care professional. Always ask your health care||
0704|007|Z|professional for complete information about this product and your||
0704|008|Z|specific health needs.||
0704|009|B|||
0704|010|T|GUAIFENESIN/DEXTROMETHORPHAN - ORAL||
0704|011|F|(gweye-FEN-eh-sin/dex-trow-meth-OR-fan)||
0704|012|B|||
0704|013|C|COMMON BRAND NAME(S): Robitussin DM||
0704|014|B|||
0704|015|U|USES:  This combination medication is used to relieve coughs||
0704|016|U|caused by the common cold, bronchitis, and other breathing||
0704|017|U|illnesses. Guaifenesin belongs to a class of drugs known as||
0704|018|U|expectorants. It works by thinning and loosening mucus in the||
0704|019|U|airways, clearing congestion, and making breathing easier.||
0704|020|U|Dextromethorphan belongs to a class of drugs known as cough||
0704|021|U|suppressants. It acts on a part of the brain (cough center) to||
0704|022|U|reduce the urge to cough.||
0704|023|U|   If you are self-treating with this medication, it is important||
0704|024|U|to read the package instructions carefully before you start using||
0704|025|U|this product to be sure it is right for you. (See also||
0704|026|U|Precautions section.)||
0704|027|U|   Cough-and-cold products have not been shown to be safe or||
0704|028|U|effective in children younger than 6 years. Do not use this||
0704|029|U|product to treat cold symptoms in children younger than 6 years||
0704|030|U|unless specifically directed by the doctor. Some products (such||
0704|031|U|as long-acting tablets/capsules) are not recommended for use in||
0704|032|U|children younger than 12 years. Ask your doctor or pharmacist for||
0704|033|U|more details about using your product safely.||
0704|034|U|   These products do not cure or shorten the length of the common||
0704|035|U|cold and may cause serious side effects. To decrease the risk for||
0704|036|U|serious side effects, carefully follow all dosage directions. Do||
0704|037|U|not use this product to make a child sleepy. Do not give other||
0704|038|U|cough-and-cold medication that might contain the same or similar||
0704|039|U|ingredients (see also Drug Interactions section). Ask the doctor||
0704|040|U|or pharmacist about other ways to relieve cough and cold symptoms||
0704|041|U|(such as drinking enough fluids, using a humidifier or saline||
0704|042|U|nose drops/spray).||
0704|043|B|||
0704|044|H|HOW TO USE:  Take this medication by mouth with or without food,||
0704|045|H|as directed by your doctor. If you are self-treating, follow all||
0704|046|H|directions on the product package. If you have any questions, ask||
0704|047|H|your doctor or pharmacist.||
0704|048|H|   Drink plenty of fluids while taking this medication. Fluids||
0704|049|H|will help to break up mucus and clear congestion.||
0704|050|H|   Dosage is based on your age, medical condition, and response||
0704|051|H|to treatment. Do not increase your dose or take this drug more||
0704|052|H|often than directed.||
0704|053|H|   If you are using the liquid form of this medication, carefully||
0704|054|H|measure the dose using a special measuring device/spoon. Do not||
0704|055|H|use a household spoon because you may not get the correct dose.||
0704|056|H|   For powder packets, empty the entire contents of the packet||
0704|057|H|onto the tongue and swallow. To prevent a bitter taste, do not||
0704|058|H|chew. If you are taking the capsule form, swallow the capsule||
0704|059|H|whole.||
0704|060|H|   Improper use of this medication (abuse) may result in serious||
0704|061|H|harm (such as brain damage, seizure, death). Do not increase your||
0704|062|H|dose, take it more often, or use it for a longer time than||
0704|063|H|directed.||
0704|064|H|   Tell your doctor if your cough returns, or if it is||
0704|065|H|accompanied by a headache that doesn't go away, fever, severe||
0704|066|H|sore throat, rash, or if it lasts or gets worse after 7 days.||
0704|067|H|These may be signs of a serious medical problem. Get medical help||
0704|068|H|right away if you think you may have a serious medical problem.||
0704|069|B|||
0704|070|S|SIDE EFFECTS:  Dizziness, drowsiness, nausea, and vomiting may||
0704|071|S|occur. If any of these effects last or get worse, notify your||
0704|072|S|doctor or pharmacist promptly.||
0704|073|S|   If your doctor has directed you to use this medication,||
0704|074|S|remember that your doctor has judged that the benefit to you is||
0704|075|S|greater than the risk of side effects. Many people using this||
0704|076|S|medication do not have serious side effects.||
0704|077|S|   A very serious allergic reaction to this drug is rare.||
0704|078|S|However, get medical help right away if you notice any symptoms||
0704|079|S|of a serious allergic reaction, including: rash, itching/swelling||
0704|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0704|081|S|breathing.||
0704|082|S|   This is not a complete list of possible side effects. If you||
0704|083|S|notice other effects not listed above, contact your doctor or||
0704|084|S|pharmacist.||
0704|085|S|   In the US -||
0704|086|S|   Call your doctor for medical advice about side effects. You||
0704|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0704|088|S|www.fda.gov/medwatch.||
0704|089|S|   In Canada - Call your doctor for medical advice about side||
0704|090|S|effects. You may report side effects to Health Canada at||
0704|091|S|1-866-234-2345.||
0704|092|B|||
0704|093|P|PRECAUTIONS:  Before taking this drug, tell your doctor or||
0704|094|P|pharmacist if you are allergic to guaifenesin or||
0704|095|P|dextromethorphan; or if you have any other allergies. This||
0704|096|P|product may contain inactive ingredients, which can cause||
0704|097|P|allergic reactions or other problems. Talk to your pharmacist for||
0704|098|P|more details.||
0704|099|P|   Before using this medication, tell your doctor or pharmacist||
0704|100|P|your medical history, especially of: breathing problems (such as||
0704|101|P|emphysema, chronic bronchitis, asthma, smoker's cough), cough||
0704|102|P|with blood or large amounts of mucus, liver problems.||
0704|103|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0704|104|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0704|105|P|machinery, or do anything that needs alertness until you can do||
0704|106|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0704|107|P|are using marijuana (cannabis).||
0704|108|P|   Liquid forms of this product may contain sugar and/or alcohol.||
0704|109|P|Caution is advised if you have diabetes, liver disease, or any||
0704|110|P|other condition that requires you to limit/avoid these substances||
0704|111|P|in your diet. Ask your doctor or pharmacist about using this||
0704|112|P|product safely.||
0704|113|P|   The liquid forms and powder packets of this medication may||
0704|114|P|contain aspartame. If you have phenylketonuria (PKU) or any other||
0704|115|P|condition that requires you to restrict your intake of aspartame||
0704|116|P|(or phenylalanine), consult your doctor or pharmacist about using||
0704|117|P|this medication safely.||
0704|118|P|   Before having surgery, tell your doctor or dentist about all||
0704|119|P|the products you use (including prescription drugs,||
0704|120|P|nonprescription drugs, and herbal products).||
0704|121|P|   During pregnancy, this medication should be used only when||
0704|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
0704|123|P|   Dextromethorphan passes into breast milk. It is unknown if||
0704|124|P|guaifenesin passes into breast milk. Consult your doctor before||
0704|125|P|breastfeeding.||
0704|126|B|||
0704|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0704|128|I|medications work or increase your risk for serious side effects.||
0704|129|I|This document does not contain all possible drug interactions.||
0704|130|I|Keep a list of all the products you use (including||
0704|131|I|prescription/nonprescription drugs and herbal products) and share||
0704|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
0704|133|I|the dosage of any medicines without your doctor's approval.||
0704|134|I|   Taking certain MAO inhibitors with this medication may cause a||
0704|135|I|serious (possibly fatal) drug interaction. Avoid taking||
0704|136|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
0704|137|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
0704|138|I|tranylcypromine during treatment with this medication. Most MAO||
0704|139|I|inhibitors should also not be taken for two weeks before||
0704|140|I|treatment with this medication. Ask your doctor when to start or||
0704|141|I|stop taking this medication.||
0704|142|I|   A product that may interact with this drug is: rolapitant.||
0704|143|I|   Guaifenesin and dextromethorphan are available in both||
0704|144|I|prescription and nonprescription products. Check the labels of||
0704|145|I|all your medications to make sure you are not taking more than||
0704|146|I|one product containing guaifenesin or dextromethorphan.||
0704|147|I|   Guaifenesin may interfere with certain lab tests (such as||
0704|148|I|urine levels of certain acids), possibly causing false test||
0704|149|I|results. Make sure lab personnel and all your doctors know you||
0704|150|I|use this drug.||
0704|151|B|||
0704|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0704|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0704|154|O|poison control center right away. US residents can call||
0704|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0704|156|O|Symptoms of overdose may include: extreme drowsiness, blurred||
0704|157|O|vision, confusion, hallucinations, slow/shallow breathing,||
0704|158|O|seizures.||
0704|159|B|||
0704|160|N|NOTES:  If your doctor prescribed this medication, do not share||
0704|161|N|this medication with others.||
0704|162|N|   Keep all medical and lab appointments.||
0704|163|B|||
0704|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0704|165|D|remember. If it is near the time of the next dose, skip the||
0704|166|D|missed dose. Take your next dose at the regular time. Do not||
0704|167|D|double the dose to catch up.||
0704|168|B|||
0704|169|R|STORAGE:  Store at room temperature away from light and moisture.||
0704|170|R|Do not store in the bathroom. Do not freeze liquid forms of this||
0704|171|R|medication. Different brands of this medication have different||
0704|172|R|storage needs. Check the product package for instructions on how||
0704|173|R|to store your brand, or ask your pharmacist. Keep all medications||
0704|174|R|away from children and pets.||
0704|175|R|   Do not flush medications down the toilet or pour them into a||
0704|176|R|drain unless instructed to do so. Properly discard this product||
0704|177|R|when it is expired or no longer needed. Consult your pharmacist||
0704|178|R|or local waste disposal company.||
0704|179|B|||
0704|180|A|Information last revised July 2025.||
0704|181|A|Copyright(c) 2025 First Databank, Inc.||
0704|182|B|||
0705|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0705|002|Z|does NOT have all possible information about this product. This||
0705|003|Z|information does not assure that this product is safe, effective,||
0705|004|Z|or appropriate for you. This information is not individual||
0705|005|Z|medical advice and does not substitute for the advice of your||
0705|006|Z|health care professional. Always ask your health care||
0705|007|Z|professional for complete information about this product and your||
0705|008|Z|specific health needs.||
0705|009|B|||
0705|010|T|LEVOBUNOLOL - OPHTHALMIC||
0705|011|F|(lee-voe-BYOO-noe-lole)||
0705|012|B|||
0705|013|C|COMMON BRAND NAME(S): Betagan||
0705|014|B|||
0705|015|U|USES:  This medication is used alone or with other medications to||
0705|016|U|treat high pressure inside the eye due to glaucoma (open-angle||
0705|017|U|type) or other eye diseases (such as ocular hypertension).||
0705|018|U|Lowering high pressure inside the eye helps to prevent blindness.||
0705|019|U|Levobunolol belongs to a class of drugs known as beta blockers||
0705|020|U|and works by decreasing the amount of fluid production within the||
0705|021|U|eye.||
0705|022|B|||
0705|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0705|024|H|directed by your doctor, usually once or twice daily.||
0705|025|H|   To apply eye drops, wash your hands first. To avoid||
0705|026|H|contamination, do not touch the dropper tip or let it touch your||
0705|027|H|eye or any other surface.||
0705|028|H|   If you are wearing contact lenses, remove them before using||
0705|029|H|eye drops. Wait at least 15 minutes before replacing your contact||
0705|030|H|lenses.||
0705|031|H|   Tilt your head back, look upward, and pull down the lower||
0705|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0705|033|H|and place one drop into the pouch. Look downward and gently close||
0705|034|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0705|035|H|your eye (near the nose) and apply gentle pressure. This will||
0705|036|H|prevent the medication from draining out. Try not to blink and do||
0705|037|H|not rub your eye. Repeat these steps for your other eye if so||
0705|038|H|directed or if your dose is for more than 1 drop.||
0705|039|H|   Do not rinse the dropper. Replace the dropper cap after each||
0705|040|H|use.||
0705|041|H|   If you are using another kind of eye medication (such as drops||
0705|042|H|or ointments), wait at least 5 to 10 minutes before using the||
0705|043|H|other medications. Use eye drops before eye ointments to allow||
0705|044|H|the eye drops to enter the eye.||
0705|045|H|   Wait several minutes for your vision to clear before driving||
0705|046|H|or operating machinery.||
0705|047|H|   Use this medication regularly in order to get the most benefit||
0705|048|H|from it. To help you remember, use it at the same time(s) each||
0705|049|H|day. Keep using this medication even if you feel well. Most||
0705|050|H|people with glaucoma or high pressure in the eyes do not feel||
0705|051|H|sick.||
0705|052|B|||
0705|053|S|SIDE EFFECTS:  Temporary burning/stinging of the eye, itchy/red||
0705|054|S|eyes, headache, or dizziness may occur. If any of these effects||
0705|055|S|last or get worse, tell your doctor or pharmacist promptly.||
0705|056|S|   Remember that this medication has been prescribed because your||
0705|057|S|doctor has judged that the benefit to you is greater than the||
0705|058|S|risk of side effects. Many people using this medication do not||
0705|059|S|have serious side effects.||
0705|060|S|   Tell your doctor right away if you have any serious side||
0705|061|S|effects, including: eye pain/swelling/discharge, reduced feeling||
0705|062|S|in eye, slow/irregular heartbeat, muscle weakness, hair loss,||
0705|063|S|mental/mood changes, vision changes, tiredness, swelling of the||
0705|064|S|ankles/feet, sudden/unexplained weight gain.||
0705|065|S|   Get medical help right away if you have any very serious side||
0705|066|S|effects, including: trouble breathing, chest pain, weakness on||
0705|067|S|one side of the body, trouble speaking, confusion.||
0705|068|S|   A very serious allergic reaction to this drug is rare.||
0705|069|S|However, get medical help right away if you notice any symptoms||
0705|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0705|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0705|072|S|breathing.||
0705|073|S|   This is not a complete list of possible side effects. If you||
0705|074|S|notice other effects not listed above, contact your doctor or||
0705|075|S|pharmacist.||
0705|076|S|   In the US -||
0705|077|S|   Call your doctor for medical advice about side effects. You||
0705|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0705|079|S|www.fda.gov/medwatch.||
0705|080|S|   In Canada - Call your doctor for medical advice about side||
0705|081|S|effects. You may report side effects to Health Canada at||
0705|082|S|1-866-234-2345.||
0705|083|B|||
0705|084|P|PRECAUTIONS:  Before using levobunolol, tell your doctor or||
0705|085|P|pharmacist if you are allergic to it; or to other beta-blockers||
0705|086|P|(such as timolol, metipranolol); or if you have any other||
0705|087|P|allergies. This product may contain inactive ingredients (such as||
0705|088|P|preservatives like benzalkonium chloride, sulfites), which can||
0705|089|P|cause allergic reactions or other problems. Talk to your||
0705|090|P|pharmacist for more details.||
0705|091|P|   Before using this medication, tell your doctor or pharmacist||
0705|092|P|your medical history, especially of: breathing problems (such as||
0705|093|P|asthma, chronic obstructive pulmonary disease-COPD), heart||
0705|094|P|problems (such as heart failure, sinus bradycardia, second- or||
0705|095|P|third-degree atrioventricular block), blood circulation problems||
0705|096|P|(such as cerebrovascular insufficiency, Raynaud's disease),||
0705|097|P|overactive thyroid (hyperthyroidism), muscle weakness disorders||
0705|098|P|(such as myasthenia gravis).||
0705|099|P|   Before having surgery, tell your doctor or dentist about all||
0705|100|P|the products you use (including prescription drugs,||
0705|101|P|nonprescription drugs, and herbal products).||
0705|102|P|   This drug may make you dizzy or temporarily blur your vision.||
0705|103|P|Do not drive, use machinery, or do anything that needs alertness||
0705|104|P|or clear vision until you can do it safely. Limit alcoholic||
0705|105|P|beverages. Talk to your doctor if you are using marijuana||
0705|106|P|(cannabis).||
0705|107|P|   This product may prevent the fast/pounding heartbeat you would||
0705|108|P|usually feel when your blood sugar level falls too low||
0705|109|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0705|110|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0705|111|P|blood sugar level, such as dizziness and sweating, are not||
0705|112|P|affected by this drug.||
0705|113|P|   If you have diabetes, this product may make it harder to||
0705|114|P|control your blood sugar levels. Check your blood sugar levels||
0705|115|P|regularly as directed by your doctor. Tell your doctor right away||
0705|116|P|if you have symptoms of high blood sugar such as increased||
0705|117|P|thirst/urination. Your doctor may need to adjust your diabetes||
0705|118|P|medication, exercise program, or diet.||
0705|119|P|   During pregnancy, this medication should be used only when||
0705|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
0705|121|P|   It is unknown if this medication passes into breast milk.||
0705|122|P|Consult your doctor before breastfeeding.||
0705|123|B|||
0705|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0705|125|I|medications work or increase your risk for serious side effects.||
0705|126|I|This document does not contain all possible drug interactions.||
0705|127|I|Keep a list of all the products you use (including||
0705|128|I|prescription/nonprescription drugs and herbal products) and share||
0705|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
0705|130|I|the dosage of any medicines without your doctor's approval.||
0705|131|I|   Some products that may interact with this drug are: digoxin,||
0705|132|I|drugs for high blood pressure (including clonidine, oral beta||
0705|133|I|blockers such as propranolol, calcium channel blockers such as||
0705|134|I|diltiazem), epinephrine, phenothiazines (such as||
0705|135|I|prochlorperazine).||
0705|136|B|||
0705|137|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0705|138|O|has overdosed and has serious symptoms such as passing out or||
0705|139|O|trouble breathing, call 911. Otherwise, call a poison control||
0705|140|O|center right away. US residents can call 1-800-222-1222. Canada||
0705|141|O|residents can call 1-844-764-7669. If this product is||
0705|142|O|accidentally swallowed, you may experience symptoms such as||
0705|143|O|trouble breathing, slow/irregular heartbeat.||
0705|144|B|||
0705|145|N|NOTES:  Do not share this medication with others.||
0705|146|N|   Lab and/or medical tests (such as eye exams) should be done||
0705|147|N|while you are using this medication. Keep all medical and lab||
0705|148|N|appointments. Consult your doctor for more details.||
0705|149|B|||
0705|150|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0705|151|D|If it is near the time of the next dose, skip the missed dose.||
0705|152|D|Use your next dose at the regular time. Do not double the dose to||
0705|153|D|catch up.||
0705|154|B|||
0705|155|R|STORAGE:  Store at room temperature away from light. Keep all||
0705|156|R|medications away from children and pets.||
0705|157|R|   Do not flush medications down the toilet or pour them into a||
0705|158|R|drain unless instructed to do so. Properly discard this product||
0705|159|R|when it is expired or no longer needed. Consult your pharmacist||
0705|160|R|or local waste disposal company.||
0705|161|B|||
0705|162|A|Information last revised May 2024.||
0705|163|A|Copyright(c) 2025 First Databank, Inc.||
0705|164|B|||
0706|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0706|002|Z|does NOT have all possible information about this product. This||
0706|003|Z|information does not assure that this product is safe, effective,||
0706|004|Z|or appropriate for you. This information is not individual||
0706|005|Z|medical advice and does not substitute for the advice of your||
0706|006|Z|health care professional. Always ask your health care||
0706|007|Z|professional for complete information about this product and your||
0706|008|Z|specific health needs.||
0706|009|B|||
0706|010|T|MEDROXYPROGESTERONE ACETATE (CONTRACEPTIVE) - SUBCUTANEOUS||
0706|011|F|(med-ROX-ee-proe-JES-ter-one AS-e-tate)||
0706|012|B|||
0706|013|C|COMMON BRAND NAME(S): Depo-SubQ Provera||
0706|014|B|||
0706|015|W|WARNING:  This medication may cause serious bone loss which may||
0706|016|W|not return to normal after you stop using it. The risk of bone||
0706|017|W|loss increases with longer use of this medication and smoking. An||
0706|018|W|important time when your bones continue to build up is during||
0706|019|W|your teenage and young adult years. Use of this medication may||
0706|020|W|increase the risk of weak/brittle bones (osteoporosis), which can||
0706|021|W|lead to broken bones when you are older. Talk with your doctor||
0706|022|W|about the risks and benefits of this medication and other birth||
0706|023|W|control choices.||
0706|024|W|   This medication should not be used longer than 2 years for||
0706|025|W|birth control or for treatment of endometriosis unless other||
0706|026|W|methods/treatments will not work for you.||
0706|027|B|||
0706|028|U|USES:  This medication is used to prevent pregnancy.||
0706|029|U|Medroxyprogesterone is like a natural hormone made by the body.||
0706|030|U|   Medroxyprogesterone is also used to treat endometriosis. It||
0706|031|U|works by lowering the amount of certain hormones in the body and||
0706|032|U|decreasing the growth of abnormal tissues that cause||
0706|033|U|endometriosis. This helps reduce pain and other symptoms.||
0706|034|U|   This medication does not protect against sexually transmitted||
0706|035|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
0706|036|U|an effective barrier method (latex or polyurethane condom/dental||
0706|037|U|dams) during sexual activity will help to decrease your risk of||
0706|038|U|infection.||
0706|039|B|||
0706|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0706|041|H|from your pharmacist before you start using medroxyprogesterone||
0706|042|H|and each time you get a refill. If you have any questions, ask||
0706|043|H|your doctor or pharmacist.||
0706|044|H|   This medication is given by injection under the skin as||
0706|045|H|directed by your doctor, usually once every 3 months. The||
0706|046|H|injection is given in the stomach area or upper thigh. Before||
0706|047|H|starting this medication, you must have a negative pregnancy||
0706|048|H|test. The first injection is usually given during the first 5||
0706|049|H|days of your menstrual period or 6 weeks after the delivery of||
0706|050|H|your baby if you are breastfeeding. Follow your doctor's exact||
0706|051|H|instructions if you are switching from another birth control||
0706|052|H|method. Repeat the same dose every 12 to 14 weeks.||
0706|053|H|   Use this medication regularly to get the most benefit from it.||
0706|054|H|To help you remember, mark your calendar with a reminder. If more||
0706|055|H|than 14 weeks pass between injections, you could become pregnant.||
0706|056|H|Use a form of non-hormonal birth control (such as condoms,||
0706|057|H|diaphragm, spermicide) to prevent pregnancy until you can get the||
0706|058|H|next injection. Your doctor may direct you to first have a||
0706|059|H|pregnancy test before your next injection.||
0706|060|B|||
0706|061|S|SIDE EFFECTS:  Nausea, bloating, headache, changes in appetite,||
0706|062|S|weight gain, tiredness, swelling, acne, hot flashes, or breast||
0706|063|S|tenderness may occur. Vaginal bleeding between periods (spotting)||
0706|064|S|or missed/irregular periods may occur, especially during the||
0706|065|S|first few months of use. Injection site pain, swelling, redness,||
0706|066|S|bruising, or a hardened mass or lump may also occur. If any of||
0706|067|S|these effects last or get worse, tell your doctor or pharmacist||
0706|068|S|promptly. Your periods may stop completely after you have been||
0706|069|S|using this medication for about a year. If this occurs, your||
0706|070|S|periods will normally return after you stop using this||
0706|071|S|medication. If you miss a period and have missed an injection, or||
0706|072|S|if more than 14 weeks pass between injections and you think you||
0706|073|S|might be pregnant, contact your doctor for a pregnancy test.||
0706|074|S|   Remember that this medication has been prescribed because your||
0706|075|S|doctor has judged that the benefit to you is greater than the||
0706|076|S|risk of side effects. Many people using this medication do not||
0706|077|S|have serious side effects.||
0706|078|S|   Tell your doctor right away if you have any serious side||
0706|079|S|effects, including: nausea/vomiting that doesn't stop,||
0706|080|S|mental/mood changes (such as new/worsening depression), changes||
0706|081|S|in sexual interest/ability, swelling of the ankles/feet, bone||
0706|082|S|pain, unusual changes in vaginal bleeding (such as continuous||
0706|083|S|spotting, sudden heavy bleeding), severe stomach/abdominal/pelvic||
0706|084|S|pain, unusual weakness/tiredness, dark urine, yellowing||
0706|085|S|skin/eyes, seizure.||
0706|086|S|   This medication may increase your risk of breast cancer. Tell||
0706|087|S|your doctor right away if you have symptoms such as a lump in the||
0706|088|S|breast, nipple discharge. Ask your doctor for more details.||
0706|089|S|   Rarely, people using this medication have had very serious||
0706|090|S|(possibly fatal) problems from blood clots (such as heart attack,||
0706|091|S|stroke, blood clots in the lungs, legs, or eyes). Get medical||
0706|092|S|help right away if you have: shortness of breath/rapid breathing,||
0706|093|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
0706|094|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0706|095|S|sudden/severe headaches, trouble speaking, weakness on one side||
0706|096|S|of the body, sudden vision changes.||
0706|097|S|   A very serious allergic reaction to this drug is rare.||
0706|098|S|However, get medical help right away if you notice any symptoms||
0706|099|S|of a serious allergic reaction, including: rash, itching/swelling||
0706|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0706|101|S|breathing.||
0706|102|S|   This is not a complete list of possible side effects. If you||
0706|103|S|notice other effects not listed above, contact your doctor or||
0706|104|S|pharmacist.||
0706|105|S|   In the US -||
0706|106|S|   Call your doctor for medical advice about side effects. You||
0706|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0706|108|S|www.fda.gov/medwatch.||
0706|109|S|   In Canada - Call your doctor for medical advice about side||
0706|110|S|effects. You may report side effects to Health Canada at||
0706|111|S|1-866-234-2345.||
0706|112|B|||
0706|113|P|PRECAUTIONS:  Before using medroxyprogesterone, tell your doctor||
0706|114|P|or pharmacist if you are allergic to it; or if you have any other||
0706|115|P|allergies. This product may contain inactive ingredients, which||
0706|116|P|can cause allergic reactions or other problems. Talk to your||
0706|117|P|pharmacist for more details.||
0706|118|P|   Before using this medication, tell your doctor or pharmacist||
0706|119|P|your medical history, especially of: blood clots (for example, in||
0706|120|P|the legs, eyes, lungs), unexplained vaginal bleeding, asthma,||
0706|121|P|abnormal breast exam, personal or family history of cancer||
0706|122|P|(especially breast or cervical cancer), daily use of||
0706|123|P|alcohol/tobacco, depression, diabetes, eating disorder||
0706|124|P|(anorexia), heart problems (such as heart failure, irregular||
0706|125|P|heartbeat, previous heart attack), high blood pressure, kidney||
0706|126|P|disease, liver disease (including tumors), high cholesterol or||
0706|127|P|triglyceride (blood fat) levels, migraines, seizures, stroke or||
0706|128|P|"mini" stroke (transient ischemic attack), personal or family||
0706|129|P|history of bone disease (such as osteoporosis).||
0706|130|P|   Before having surgery, tell your doctor or dentist about all||
0706|131|P|the products you use (including prescription drugs,||
0706|132|P|nonprescription drugs, and herbal products).||
0706|133|P|   It may take longer for you to become pregnant after you stop||
0706|134|P|using this medication. Consult your doctor.||
0706|135|P|   This medication should not be used during pregnancy. If you||
0706|136|P|become pregnant or think you may be pregnant, tell your doctor||
0706|137|P|right away.||
0706|138|P|   This drug passes into breast milk. Consult your doctor before||
0706|139|P|breastfeeding.||
0706|140|B|||
0706|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0706|142|I|medications work or increase your risk for serious side effects.||
0706|143|I|This document does not contain all possible drug interactions.||
0706|144|I|Keep a list of all the products you use (including||
0706|145|I|prescription/nonprescription drugs and herbal products) and share||
0706|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
0706|147|I|the dosage of any medicines without your doctor's approval.||
0706|148|I|   A product that may interact with this drug is: warfarin.||
0706|149|I|   Some drugs may cause hormonal birth control to work less well||
0706|150|I|by decreasing the amount of birth control hormones in your body.||
0706|151|I|This effect can result in pregnancy. Examples include||
0706|152|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
0706|153|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
0706|154|I|seizures (such as barbiturates, carbamazepine, felbamate,||
0706|155|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
0706|156|I|nevirapine), among others.||
0706|157|I|   Tell your doctor when you start any new drug, and discuss if||
0706|158|I|you should use reliable backup birth control. Also tell your||
0706|159|I|doctor if you have any new spotting or breakthrough bleeding,||
0706|160|I|because these may be signs that your birth control is not working||
0706|161|I|well.||
0706|162|I|   This medication may interfere with certain lab tests (such as||
0706|163|I|certain hormone levels, blood tests for clotting factors,||
0706|164|I|thyroid/liver function tests), possibly causing false test||
0706|165|I|results. Make sure lab personnel and all your doctors know you||
0706|166|I|use this drug.||
0706|167|B|||
0706|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0706|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0706|170|O|poison control center right away. US residents can call||
0706|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0706|172|B|||
0706|173|N|NOTES:  Do not share this medication with others.||
0706|174|N|   Regular complete physical exams which include lab and/or||
0706|175|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
0706|176|N|Pap smear) should be done while you are using this medication.||
0706|177|N|Follow your doctor's instructions for examining your breasts, and||
0706|178|N|report any lumps right away. Keep all medical and lab||
0706|179|N|appointments. Consult your doctor for more details. Your doctor||
0706|180|N|may test your bone density while you are using this medication.||
0706|181|N|Be sure to get enough vitamin D and calcium in your diet. Ask||
0706|182|N|your doctor or pharmacist about calcium/vitamin D supplements to||
0706|183|N|help keep your bones healthy.||
0706|184|B|||
0706|185|D|MISSED DOSE:  It is important to get each dose of this medication||
0706|186|D|as scheduled. If you miss a dose and more than 14 weeks have||
0706|187|D|passed between injections, ask your doctor right away for||
0706|188|D|instructions. You will need a pregnancy test to make sure you are||
0706|189|D|not pregnant before getting another injection. Other birth||
0706|190|D|control methods (such as spermicide, condoms) must be used to||
0706|191|D|protect you from getting pregnant until you can get the next||
0706|192|D|injection.||
0706|193|B|||
0706|194|R|STORAGE:  Not applicable. This medication is given in a clinic or||
0706|195|R|doctor's office and will not be stored at home.||
0706|196|B|||
0706|197|A|Information last revised October 2025.||
0706|198|A|Copyright(c) 2025 First Databank, Inc.||
0706|199|B|||
0708|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0708|002|Z|does NOT have all possible information about this product. This||
0708|003|Z|information does not assure that this product is safe, effective,||
0708|004|Z|or appropriate for you. This information is not individual||
0708|005|Z|medical advice and does not substitute for the advice of your||
0708|006|Z|health care professional. Always ask your health care||
0708|007|Z|professional for complete information about this product and your||
0708|008|Z|specific health needs.||
0708|009|B|||
0708|010|T|LISOCABTAGENE MARALEUCEL - INJECTION||
0708|011|F|(LIS-oh-KAB-ta-jeen MAR-a-LOO-sel)||
0708|012|B|||
0708|013|C|COMMON BRAND NAME(S): Breyanzi||
0708|014|B|||
0708|015|W|WARNING:  This medication may cause a serious (even fatal)||
0708|016|W|reaction called cytokine release syndrome-CRS. Careful monitoring||
0708|017|W|and prompt treatment may decrease your risk. Before treatment||
0708|018|W|with this medication, tell your doctor your medical history,||
0708|019|W|especially of any current/recent infection. Tell your doctor||
0708|020|W|right away if you have any symptoms of CRS such as high fever,||
0708|021|W|trouble breathing, chills/shaking chills, severe||
0708|022|W|nausea/vomiting/diarrhea, severe muscle/joint pain, very low||
0708|023|W|blood pressure, dizziness/lightheadedness.||
0708|024|W|   Serious nerve problems can occur after treatment with||
0708|025|W|lisocabtagene maraleucel. Tell your doctor right away if you have||
0708|026|W|drowsiness, seizure(s), mental/mood changes (such as confusion,||
0708|027|W|anxiety, memory loss), or trouble with reading, writing,||
0708|028|W|speaking, or understanding.||
0708|029|W|   Although lisocabtagene maraleucel is used to treat cancer, it||
0708|030|W|may rarely increase your risk of developing other cancers. Tell||
0708|031|W|your doctor right away if you develop symptoms such as unusual||
0708|032|W|growths or lumps or swollen lymph nodes.||
0708|033|B|||
0708|034|U|USES:  Lisocabtagene maraleucel is used to treat certain types of||
0708|035|U|cancer (large B-cell lymphoma - LBCL, chronic lymphocytic||
0708|036|U|leukemia - CLL, small lymphocytic lymphoma - SLL, follicular||
0708|037|U|lymphoma - FL, mantle cell lymphoma - MCL). This type of||
0708|038|U|treatment is known as gene therapy. Lisocabtagene maraleucel is||
0708|039|U|made from your own white blood cells and is given only to you.||
0708|040|U|The white blood cells have been changed to have a specific||
0708|041|U|protein (chimeric antigen receptor-CAR) that helps your body slow||
0708|042|U|or stop the growth of certain cancer cells.||
0708|043|B|||
0708|044|H|HOW TO USE:  Read the Medication Guide provided by your health||
0708|045|H|care professional before you start using this product. If you||
0708|046|H|have any questions, ask your health care professionals.||
0708|047|H|   Your doctor will give you 3 days of chemotherapy before||
0708|048|H|treatment with this product to prepare your body.||
0708|049|H|   This product is given by slow injection into a vein as||
0708|050|H|directed by your doctor. You will receive injections of 2||
0708|051|H|different cell types, one right after another. Each cell type||
0708|052|H|injection will usually be given over less than 15 minutes. To||
0708|053|H|decrease the risk of side effects, your doctor may also give you||
0708|054|H|other medications (such as acetaminophen, diphenhydramine) before||
0708|055|H|injecting lisocabtagene maraleucel.||
0708|056|H|   Your doctor will check you daily for at least 7 days after||
0708|057|H|your treatment to see how well it works and help you manage any||
0708|058|H|side effects. You should plan to stay for at least 2 weeks near||
0708|059|H|the place of your treatment (for example, within 2 hours' drive).||
0708|060|B|||
0708|061|S|SIDE EFFECTS:  See also Warning section.||
0708|062|S|   Headache, tiredness, trouble sleeping, or loss of appetite may||
0708|063|S|occur. If any of these effects last or get worse, tell your||
0708|064|S|doctor or pharmacist promptly.||
0708|065|S|   People using this medication may have serious side effects.||
0708|066|S|However, you have been prescribed this drug because your doctor||
0708|067|S|has judged that the benefit to you is greater than the risk of||
0708|068|S|side effects. Careful monitoring by your doctor may decrease your||
0708|069|S|risk.||
0708|070|S|   Tell your doctor right away if you have any serious side||
0708|071|S|effects, including: fast/irregular heartbeat, signs of kidney||
0708|072|S|problems (such as change in the amount of urine).||
0708|073|S|   This product may cause a severe decrease in your blood cells,||
0708|074|S|which lowers your ability to fight infections and increases the||
0708|075|S|risk of anemia/bleeding problems. You may be more likely to get a||
0708|076|S|serious (rarely fatal) infection and any infection you have may||
0708|077|S|get worse. Tell your doctor right away if you develop signs of||
0708|078|S|infection (such as sore throat that doesn't go away, fever,||
0708|079|S|chills), easy or unusual bruising/bleeding, or unusual tiredness.||
0708|080|S|   A very serious allergic reaction to this drug is rare.||
0708|081|S|However, get medical help right away if you notice any symptoms||
0708|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0708|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0708|084|S|breathing.||
0708|085|S|   This is not a complete list of possible side effects. If you||
0708|086|S|notice other effects not listed above, contact your doctor or||
0708|087|S|pharmacist.||
0708|088|S|   In the US -||
0708|089|S|   Call your doctor for medical advice about side effects. You||
0708|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0708|091|S|www.fda.gov/medwatch.||
0708|092|S|   In Canada - Call your doctor for medical advice about side||
0708|093|S|effects. You may report side effects to Health Canada at||
0708|094|S|1-866-234-2345.||
0708|095|B|||
0708|096|P|PRECAUTIONS:  Before receiving lisocabtagene maraleucel, tell||
0708|097|P|your doctor or pharmacist if you have any allergies. This product||
0708|098|P|may contain inactive ingredients, which can cause allergic||
0708|099|P|reactions or other problems. Talk to your pharmacist for more||
0708|100|P|details.||
0708|101|P|   Before using this medication, tell your doctor or pharmacist||
0708|102|P|your medical history, especially of: heart problems, kidney/liver||
0708|103|P|problems, lung or breathing problems, nerve problems (such as||
0708|104|P|memory loss, seizures), past/current/recent infection.||
0708|105|P|   This product can make you more likely to get infections or may||
0708|106|P|make current infections worse. Stay away from anyone who has an||
0708|107|P|infection that may easily spread (such as chickenpox, COVID-19,||
0708|108|P|measles, flu). Talk to your doctor if you have been exposed to an||
0708|109|P|infection or for more details.||
0708|110|P|   Tell your health care professional that you are using||
0708|111|P|lisocabtagene maraleucel before having any||
0708|112|P|immunizations/vaccinations. Avoid contact with people who have||
0708|113|P|recently received live vaccines (such as flu vaccine inhaled||
0708|114|P|through the nose).||
0708|115|P|   To lower the chance of getting cut, bruised, or injured, use||
0708|116|P|caution with sharp objects like razors and nail cutters, and||
0708|117|P|avoid activities such as contact sports.||
0708|118|P|   This drug may make you drowsy or dizzy, affect your||
0708|119|P|coordination, or make it harder for you to think clearly. Alcohol||
0708|120|P|or marijuana (cannabis) can worsen these effects. Do not drive,||
0708|121|P|use machinery, or do anything that needs alertness until you can||
0708|122|P|do it safely (at least 2 weeks after receiving treatment is||
0708|123|P|recommended by the manufacturer). Limit alcoholic beverages. Talk||
0708|124|P|to your doctor if you are using marijuana (cannabis).||
0708|125|P|   Before having surgery, tell your doctor or dentist about all||
0708|126|P|the products you use (including prescription drugs,||
0708|127|P|nonprescription drugs, and herbal products).||
0708|128|P|   Tell your doctor if you are pregnant or plan to become||
0708|129|P|pregnant. You should not become pregnant while using this||
0708|130|P|product. Lisocabtagene maraleucel may harm an unborn baby. Your||
0708|131|P|doctor should order a pregnancy test before you start this||
0708|132|P|medication. If you become pregnant, talk to your doctor right||
0708|133|P|away about the risks and benefits of this medication.||
0708|134|P|   It is unknown if this product passes into breast milk. Consult||
0708|135|P|your doctor before breastfeeding.||
0708|136|B|||
0708|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0708|138|I|medications work or increase your risk for serious side effects.||
0708|139|I|This document does not contain all possible drug interactions.||
0708|140|I|Keep a list of all the products you use (including||
0708|141|I|prescription/nonprescription drugs and herbal products) and share||
0708|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
0708|143|I|the dosage of any medicines without your doctor's approval.||
0708|144|I|   This medication may interfere with certain lab tests (such as||
0708|145|I|some HIV tests), possibly causing false test results. Make sure||
0708|146|I|lab personnel and all your doctors know you use this drug.||
0708|147|B|||
0708|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0708|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0708|150|O|poison control center right away. US residents can call||
0708|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0708|152|B|||
0708|153|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
0708|154|N|should be done before and after you receive this product. Keep||
0708|155|N|all medical and lab appointments.||
0708|156|N|   After receiving this treatment, do not donate blood, organs,||
0708|157|N|tissues, or cells.||
0708|158|B|||
0708|159|D|MISSED DOSE:  Not applicable.||
0708|160|B|||
0708|161|R|STORAGE:  Not applicable. This product is given in a hospital or||
0708|162|R|clinic and will not be stored at home.||
0708|163|B|||
0708|164|M|MEDICAL ALERT:  Your condition can cause complications in a||
0708|165|M|medical emergency. For information about enrolling in MedicAlert,||
0708|166|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0708|167|B|||
0708|168|A|Information last revised June 2025.||
0708|169|A|Copyright(c) 2025 First Databank, Inc.||
0708|170|B|||
0710|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0710|002|Z|does NOT have all possible information about this product. This||
0710|003|Z|information does not assure that this product is safe, effective,||
0710|004|Z|or appropriate for you. This information is not individual||
0710|005|Z|medical advice and does not substitute for the advice of your||
0710|006|Z|health care professional. Always ask your health care||
0710|007|Z|professional for complete information about this product and your||
0710|008|Z|specific health needs.||
0710|009|B|||
0710|010|T|BISOPROLOL/HYDROCHLOROTHIAZIDE - ORAL||
0710|011|F|(BIS-oh-PROE-lol/HYE-droe-KLOR-oh-THYE-a-zide)||
0710|012|B|||
0710|013|C|COMMON BRAND NAME(S): Ziac||
0710|014|B|||
0710|015|W|WARNING:  If you have chest pain (angina) or heart disease (such||
0710|016|W|as coronary artery disease, ischemic heart disease, high blood||
0710|017|W|pressure), do not stop using this drug without first consulting||
0710|018|W|your doctor. Your condition may become worse when the drug is||
0710|019|W|suddenly stopped. If your doctor decides you should no longer use||
0710|020|W|this drug, you must gradually decrease your dose according to||
0710|021|W|your doctor's instructions.||
0710|022|W|   When gradually stopping this medication, it is recommended||
0710|023|W|that you temporarily limit physical activity to decrease strain||
0710|024|W|on the heart. Get medical help right away if you develop:||
0710|025|W|worsening chest pain, tightness or pressure in the chest, chest||
0710|026|W|pain spreading to the jaw/neck/arm, sweating, trouble breathing,||
0710|027|W|or fast/irregular heartbeat.||
0710|028|B|||
0710|029|U|USES:  This combination medication is used to treat high blood||
0710|030|U|pressure (hypertension). Lowering high blood pressure helps||
0710|031|U|prevent strokes, heart attacks, and kidney problems.||
0710|032|U|   This product contains two medications. Bisoprolol is a beta||
0710|033|U|blocker that works by blocking the effect of certain natural||
0710|034|U|chemicals (such as epinephrine) on the heart and blood vessels.||
0710|035|U|This slows your heartbeat, lowers blood pressure, and reduces||
0710|036|U|strain on the heart. Hydrochlorothiazide is a "water pill"||
0710|037|U|(diuretic) that works by increasing the amount of urine that you||
0710|038|U|make. This causes your body to get rid of extra salt and water,||
0710|039|U|which probably helps to relax the blood vessels so that blood can||
0710|040|U|flow more easily. These two drugs are used together when one||
0710|041|U|medication is not controlling your blood pressure. Using these||
0710|042|U|two drugs together can also reduce the amount of each drug you||
0710|043|U|must take, thereby decreasing the chances of side effects.||
0710|044|B|||
0710|045|H|HOW TO USE:  See also Warning section.||
0710|046|H|   Take this medication by mouth with or without food as directed||
0710|047|H|by your doctor, usually once daily. The dosage is based on your||
0710|048|H|medical condition and response to treatment.||
0710|049|H|   It is best to avoid taking this medication within 4 hours of||
0710|050|H|your bedtime to avoid having to get up to urinate. Consult your||
0710|051|H|doctor or pharmacist if you have questions about your dosing||
0710|052|H|schedule.||
0710|053|H|   If you are also taking cholestyramine or colestipol, take||
0710|054|H|bisoprolol/hydrochlorothiazide at least 4 hours before or at||
0710|055|H|least 4 to 6 hours after either of those drugs.||
0710|056|H|   Use this medication regularly in order to get the most benefit||
0710|057|H|from it. To help you remember, take it at the same time each day.||
0710|058|H|Keep taking this medication even if you feel well. Most people||
0710|059|H|with high blood pressure do not feel sick. It may take up to 3||
0710|060|H|weeks before you get the full benefit of this drug.||
0710|061|H|   Tell your doctor if your condition does not get better or if||
0710|062|H|it gets worse (your blood pressure readings remain high or||
0710|063|H|increase).||
0710|064|B|||
0710|065|S|SIDE EFFECTS:  See also Precautions section.||
0710|066|S|   Dizziness, lightheadedness, tiredness, and drowsiness may||
0710|067|S|occur as your body adjusts to the medication. Nausea, stomach||
0710|068|S|upset, diarrhea, cough, constipation and trouble sleeping may||
0710|069|S|also occur. If any of these effects last or get worse, tell your||
0710|070|S|doctor or pharmacist promptly.||
0710|071|S|   To reduce the risk of dizziness and lightheadedness, get up||
0710|072|S|slowly when rising from a sitting or lying position.||
0710|073|S|   This product may reduce blood flow to your hands and feet,||
0710|074|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0710|075|S|warmly and avoid tobacco use.||
0710|076|S|   Remember that this medication has been prescribed because your||
0710|077|S|doctor has judged that the benefit to you is greater than the||
0710|078|S|risk of side effects. Many people using this medication do not||
0710|079|S|have serious side effects.||
0710|080|S|   The hydrochlorothiazide in this product may cause dehydration||
0710|081|S|and electrolyte imbalance. Tell your doctor right away if you||
0710|082|S|have any symptoms of dehydration or electrolyte imbalance,||
0710|083|S|including unusual dry mouth/thirst, muscle cramps/weakness,||
0710|084|S|slow/fast/irregular heartbeat, or confusion.||
0710|085|S|   Tell your doctor right away if you have any serious side||
0710|086|S|effects, including: very slow/irregular heartbeat, fainting,||
0710|087|S|swelling of the ankles/feet, shortness of breath,||
0710|088|S|sudden/unexplained weight gain, loss of feeling/tingling in the||
0710|089|S|fingers/toes, hair loss, decrease in vision, eye pain,||
0710|090|S|mental/mood changes (such as nervousness, confusion), shaking,||
0710|091|S|decreased sexual ability/interest, muscle/joint pain, signs of||
0710|092|S|liver disease (such as nausea/vomiting that doesn't stop, loss of||
0710|093|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0710|094|S|urine), easy bruising/bleeding, signs of kidney problems (such as||
0710|095|S|change in the amount of urine).||
0710|096|S|   A very serious allergic reaction to this drug is rare.||
0710|097|S|However, get medical help right away if you notice any symptoms||
0710|098|S|of a serious allergic reaction, including: rash, itching/swelling||
0710|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0710|100|S|breathing.||
0710|101|S|   This is not a complete list of possible side effects. If you||
0710|102|S|notice other effects not listed above, contact your doctor or||
0710|103|S|pharmacist.||
0710|104|S|   In the US -||
0710|105|S|   Call your doctor for medical advice about side effects. You||
0710|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0710|107|S|www.fda.gov/medwatch.||
0710|108|S|   In Canada - Call your doctor for medical advice about side||
0710|109|S|effects. You may report side effects to Health Canada at||
0710|110|S|1-866-234-2345.||
0710|111|B|||
0710|112|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0710|113|P|pharmacist if you are allergic to bisoprolol or||
0710|114|P|hydrochlorothiazide; or to other beta blockers (such as||
0710|115|P|metoprolol, atenolol); or to other thiazide diuretics (such as||
0710|116|P|chlorothiazide); or if you have any other allergies. This product||
0710|117|P|may contain inactive ingredients, which can cause allergic||
0710|118|P|reactions or other problems. Talk to your pharmacist for more||
0710|119|P|details.||
0710|120|P|   Before using this medication, tell your doctor or pharmacist||
0710|121|P|your medical history, especially of: kidney disease, liver||
0710|122|P|disease, certain types of heart rhythm problems (such as sinus||
0710|123|P|bradycardia, second- or third-degree atrioventricular block),||
0710|124|P|heart failure, lung disease (such as asthma, bronchitis, chronic||
0710|125|P|obstructive pulmonary disease-COPD), overactive thyroid||
0710|126|P|(hyperthyroidism), diabetes, gout, untreated salt imbalance (such||
0710|127|P|as high calcium, low potassium/magnesium), dehydration, blood||
0710|128|P|circulation problems (such as peripheral vascular disease),||
0710|129|P|certain muscle diseases (such as myasthenia gravis), lupus,||
0710|130|P|recent nerve surgery (such as sympathectomy), skin cancer.||
0710|131|P|   Before having surgery, tell your doctor or dentist about all||
0710|132|P|the products you use (including prescription drugs,||
0710|133|P|nonprescription drugs, and herbal products).||
0710|134|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0710|135|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0710|136|P|machinery, or do anything that needs alertness until you can do||
0710|137|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0710|138|P|are using marijuana (cannabis).||
0710|139|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0710|140|P|and cause you to feel lightheaded. Tell your doctor if you have||
0710|141|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0710|142|P|of fluids unless your doctor tells you not to.||
0710|143|P|   This product may prevent the fast/pounding heartbeat you would||
0710|144|P|usually feel when your blood sugar level falls too low||
0710|145|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0710|146|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0710|147|P|blood sugar level, such as dizziness and sweating, are not||
0710|148|P|affected by this drug.||
0710|149|P|   If you have diabetes, this product may make it harder to||
0710|150|P|control your blood sugar levels. Check your blood sugar levels||
0710|151|P|regularly as directed by your doctor. Tell your doctor right away||
0710|152|P|if you have symptoms of high blood sugar such as increased||
0710|153|P|thirst/urination. Your doctor may need to adjust your diabetes||
0710|154|P|medication, exercise program, or diet.||
0710|155|P|   This medication may reduce the potassium levels in your blood.||
0710|156|P|Ask your doctor about adding potassium to your diet. A potassium||
0710|157|P|supplement may be prescribed by your doctor.||
0710|158|P|   This medication may make you more sensitive to the sun. It may||
0710|159|P|also increase your risk for skin cancer, especially if you take||
0710|160|P|it for a long time. Limit your time in the sun. Avoid tanning||
0710|161|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0710|162|P|when outdoors. Tell your doctor right away if you get sunburned,||
0710|163|P|have skin blisters/redness, or notice new or changed moles/skin||
0710|164|P|lesions.||
0710|165|P|   During pregnancy, this medication should be used only when||
0710|166|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0710|167|P|benefits with your doctor.||
0710|168|P|   This drug passes into breast milk and could have undesirable||
0710|169|P|effects on a nursing infant. Consult your doctor before||
0710|170|P|breastfeeding.||
0710|171|B|||
0710|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0710|173|I|medications work or increase your risk for serious side effects.||
0710|174|I|This document does not contain all possible drug interactions.||
0710|175|I|Keep a list of all the products you use (including||
0710|176|I|prescription/nonprescription drugs and herbal products) and share||
0710|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
0710|178|I|the dosage of any medicines without your doctor's approval.||
0710|179|I|   Some products that may interact with this drug are: alpha||
0710|180|I|blockers (such as prazosin, terazosin), digoxin, dofetilide,||
0710|181|I|drugs that affect heart rhythm (such as disopyramide),||
0710|182|I|epinephrine, fenoldopam, fingolimod, lithium, other drugs for||
0710|183|I|high blood pressure (such as clonidine), probenecid, St John's||
0710|184|I|wort.||
0710|185|I|   Some products have ingredients that could raise your blood||
0710|186|I|pressure. Tell your pharmacist what products you are using, and||
0710|187|I|ask how to use them safely (especially cough-and-cold products,||
0710|188|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0710|189|I|   This medication may interfere with certain lab tests (such as||
0710|190|I|parathyroid, protein-bound iodide, tyramine and phentolamine||
0710|191|I|tests), possibly causing false test results. Make sure lab||
0710|192|I|personnel and all your doctors know you use this drug.||
0710|193|B|||
0710|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0710|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0710|196|O|poison control center right away. US residents can call||
0710|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0710|198|O|Symptoms of overdose may include: very slow heartbeat, severe||
0710|199|O|dizziness, fainting, severe weakness, trouble breathing.||
0710|200|B|||
0710|201|N|NOTES:  Do not share this medication with others.||
0710|202|N|   Talk with your doctor about making changes to your lifestyle||
0710|203|N|that may increase the effectiveness of this medication (such as||
0710|204|N|stress reduction programs, exercise, and dietary changes).||
0710|205|N|   Lab and/or medical tests (such as potassium levels, liver||
0710|206|N|function, complete blood counts, skin exams, cholesterol levels)||
0710|207|N|should be done while you are taking this medication. Keep all||
0710|208|N|medical and lab appointments. Consult your doctor for more||
0710|209|N|details.||
0710|210|N|   Have your blood pressure checked regularly while taking this||
0710|211|N|medication. Learn how to monitor your own blood pressure at home,||
0710|212|N|and share the results with your doctor.||
0710|213|B|||
0710|214|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0710|215|D|remember. If it is near the time of the next dose, skip the||
0710|216|D|missed dose. Take your next dose at the regular time. Do not||
0710|217|D|double the dose to catch up.||
0710|218|B|||
0710|219|R|STORAGE:  Store at room temperature away from light and moisture.||
0710|220|R|Do not store in the bathroom. Keep all medications away from||
0710|221|R|children and pets.||
0710|222|R|   Do not flush medications down the toilet or pour them into a||
0710|223|R|drain unless instructed to do so. Properly discard this product||
0710|224|R|when it is expired or no longer needed. Consult your pharmacist||
0710|225|R|or local waste disposal company.||
0710|226|B|||
0710|227|A|Information last revised April 2025.||
0710|228|A|Copyright(c) 2025 First Databank, Inc.||
0710|229|B|||
0711|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0711|002|Z|does NOT have all possible information about this product. This||
0711|003|Z|information does not assure that this product is safe, effective,||
0711|004|Z|or appropriate for you. This information is not individual||
0711|005|Z|medical advice and does not substitute for the advice of your||
0711|006|Z|health care professional. Always ask your health care||
0711|007|Z|professional for complete information about this product and your||
0711|008|Z|specific health needs.||
0711|009|B|||
0711|010|T|PINDOLOL/HYDROCHLOROTHIAZIDE - ORAL||
0711|011|F|(PIN-doe-lole/HYE-droe-KLOR-oh-THYE-a-zide)||
0711|012|B|||
0711|013|W|WARNING:  If you have chest pain (angina) or heart disease (such||
0711|014|W|as coronary artery disease, ischemic heart disease, high blood||
0711|015|W|pressure), do not stop using this drug without first consulting||
0711|016|W|your doctor. Your condition may become worse when the drug is||
0711|017|W|suddenly stopped. If your doctor decides you should no longer use||
0711|018|W|this drug, you must gradually decrease your dose according to||
0711|019|W|your doctor's instructions.||
0711|020|W|   When gradually stopping this medication, it is recommended||
0711|021|W|that you temporarily limit physical activity to decrease strain||
0711|022|W|on the heart. Get medical help right away if you develop:||
0711|023|W|worsening chest pain, tightness or pressure in the chest, chest||
0711|024|W|pain spreading to the jaw/neck/arm, sweating, trouble breathing,||
0711|025|W|or fast/irregular heartbeat.||
0711|026|B|||
0711|027|U|USES:  This combination medication is used with or without other||
0711|028|U|medications to treat high blood pressure (hypertension). Lowering||
0711|029|U|high blood pressure helps prevent strokes, heart attacks, and||
0711|030|U|kidney problems.||
0711|031|U|   This product contains two medications. Pindolol is a beta||
0711|032|U|blocker that works by blocking the effect of certain natural||
0711|033|U|chemicals (such as epinephrine) on the heart and blood vessels.||
0711|034|U|This slows your heartbeat, lowers blood pressure, and reduces||
0711|035|U|strain on the heart. Hydrochlorothiazide is a "water pill"||
0711|036|U|(diuretic) that works by increasing the amount of urine that you||
0711|037|U|make. This causes your body to get rid of extra salt and water,||
0711|038|U|which probably helps to relax the blood vessels so that blood can||
0711|039|U|flow more easily. These two drugs are used together when one||
0711|040|U|medication is not controlling your blood pressure.||
0711|041|U|   This medication is not recommended as the first medication for||
0711|042|U|treating high blood pressure. Your doctor will usually start you||
0711|043|U|on the individual medications first, and then switch you over to||
0711|044|U|this combination product if this is the best dose combination for||
0711|045|U|you.||
0711|046|B|||
0711|047|H|HOW TO USE:  See also Warning section.||
0711|048|H|   Take this medication by mouth with or without food as directed||
0711|049|H|by your doctor, usually once daily. It is best to avoid taking||
0711|050|H|this medication within 4 hours of your bedtime to avoid having to||
0711|051|H|get up to urinate. Consult your doctor or pharmacist if you have||
0711|052|H|questions about your dosing schedule.||
0711|053|H|   The dosage is based on your medical condition and response to||
0711|054|H|treatment.||
0711|055|H|   If you also take certain drugs to lower your cholesterol (bile||
0711|056|H|acid-binding resins such as cholestyramine or colestipol), take||
0711|057|H|this product at least 4 hours before or at least 4 to 6 hours||
0711|058|H|after these medications.||
0711|059|H|   Use this medication regularly in order to get the most benefit||
0711|060|H|from it. To help you remember, take it at the same time each day.||
0711|061|H|Keep taking this medication even if you feel well. Most people||
0711|062|H|with high blood pressure do not feel sick. It may take up to||
0711|063|H|several weeks before you get the full benefit of this drug.||
0711|064|H|   Tell your doctor if your condition does not get better or if||
0711|065|H|it gets worse (your blood pressure readings remain high or||
0711|066|H|increase).||
0711|067|B|||
0711|068|S|SIDE EFFECTS:  See also Precautions section.||
0711|069|S|   Dizziness, lightheadedness, tiredness, blurred vision and||
0711|070|S|drowsiness may occur as your body adjusts to the medication.||
0711|071|S|Nausea, stomach upset, diarrhea, constipation and trouble||
0711|072|S|sleeping may also occur. If any of these effects last or get||
0711|073|S|worse, tell your doctor or pharmacist promptly.||
0711|074|S|   To reduce the risk of dizziness and lightheadedness, get up||
0711|075|S|slowly when rising from a sitting or lying position.||
0711|076|S|   This product may reduce blood flow to your hands and feet,||
0711|077|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0711|078|S|warmly and avoid tobacco use.||
0711|079|S|   Remember that this medication has been prescribed because your||
0711|080|S|doctor has judged that the benefit to you is greater than the||
0711|081|S|risk of side effects. Many people using this medication do not||
0711|082|S|have serious side effects.||
0711|083|S|   This product may cause dehydration and electrolyte imbalance.||
0711|084|S|Tell your doctor right away if you have any symptoms of||
0711|085|S|dehydration or electrolyte imbalance, including unusual dry||
0711|086|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0711|087|S|heartbeat, or confusion.||
0711|088|S|   Tell your doctor right away if you have any serious side||
0711|089|S|effects, including: fainting, very slow/irregular heartbeat,||
0711|090|S|swelling ankles/feet, sudden/unexplained weight gain, loss of||
0711|091|S|feeling/tingling in the fingers/toes, hair loss, mental/mood||
0711|092|S|changes (such as confusion, nervousness), decreased sexual||
0711|093|S|ability/interest, muscle/joint pain, decrease in vision, eye||
0711|094|S|pain, signs of liver problems (such as nausea/vomiting that||
0711|095|S|doesn't stop, yellowing eyes/skin, stomach/abdominal pain, dark||
0711|096|S|urine), shaking, easy bruising/bleeding, signs of infection (such||
0711|097|S|as sore throat that doesn't go away, fever, chills), signs of||
0711|098|S|kidney problems (such as change in the amount of urine).||
0711|099|S|   A very serious allergic reaction to this drug is rare.||
0711|100|S|However, get medical help right away if you notice any symptoms||
0711|101|S|of a serious allergic reaction, including: rash, itching/swelling||
0711|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0711|103|S|breathing.||
0711|104|S|   This is not a complete list of possible side effects. If you||
0711|105|S|notice other effects not listed above, contact your doctor or||
0711|106|S|pharmacist.||
0711|107|S|   In the US -||
0711|108|S|   Call your doctor for medical advice about side effects. You||
0711|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0711|110|S|www.fda.gov/medwatch.||
0711|111|S|   In Canada - Call your doctor for medical advice about side||
0711|112|S|effects. You may report side effects to Health Canada at||
0711|113|S|1-866-234-2345.||
0711|114|B|||
0711|115|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0711|116|P|pharmacist if you are allergic to pindolol or||
0711|117|P|hydrochlorothiazide; or to other beta blockers (such as||
0711|118|P|propranolol, atenolol); or to other thiazide diuretics (such as||
0711|119|P|chlorothiazide); or if you have any other allergies. This product||
0711|120|P|may contain inactive ingredients, which can cause allergic||
0711|121|P|reactions or other problems. Talk to your pharmacist for more||
0711|122|P|details.||
0711|123|P|   Before using this medication, tell your doctor or pharmacist||
0711|124|P|your medical history, especially of: breathing problems (asthma,||
0711|125|P|chronic obstructive pulmonary disease-COPD), kidney disease,||
0711|126|P|liver disease, heart problems (such as heart failure, heart||
0711|127|P|attack, slow heartbeat), pulmonary hypertension, overactive||
0711|128|P|thyroid (hyperthyroidism), diabetes, gout, untreated salt||
0711|129|P|imbalance (such as high calcium, low potassium/magnesium),||
0711|130|P|dehydration, certain muscle diseases (such as myasthenia gravis),||
0711|131|P|blood circulation problems (such as peripheral vascular disease),||
0711|132|P|lupus, recent nerve surgery (such as sympathectomy), skin cancer.||
0711|133|P|   Before having surgery, tell your doctor or dentist about all||
0711|134|P|the products you use (including prescription drugs,||
0711|135|P|nonprescription drugs, and herbal products).||
0711|136|P|   This drug may make you dizzy or drowsy or blur your vision.||
0711|137|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0711|138|P|drowsy. Do not drive, use machinery, or do anything that needs||
0711|139|P|alertness or clear vision until you can do it safely. Limit||
0711|140|P|alcoholic beverages. Talk to your doctor if you are using||
0711|141|P|marijuana (cannabis).||
0711|142|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0711|143|P|and cause you to feel lightheaded. Tell your doctor if you have||
0711|144|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0711|145|P|of fluids unless your doctor tells you not to.||
0711|146|P|   This product may prevent the fast/pounding heartbeat you would||
0711|147|P|usually feel when your blood sugar level falls too low||
0711|148|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0711|149|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0711|150|P|blood sugar level, such as dizziness and sweating, are not||
0711|151|P|affected by this drug.||
0711|152|P|   If you have diabetes, this product may make it harder to||
0711|153|P|control your blood sugar levels. Check your blood sugar levels||
0711|154|P|regularly as directed by your doctor. Tell your doctor right away||
0711|155|P|if you have symptoms of high blood sugar such as increased||
0711|156|P|thirst/urination. Your doctor may need to adjust your diabetes||
0711|157|P|medication, exercise program, or diet.||
0711|158|P|   This medication may reduce the potassium levels in your blood.||
0711|159|P|Ask your doctor about adding potassium to your diet. A potassium||
0711|160|P|supplement may be prescribed by your doctor.||
0711|161|P|   This medication may make you more sensitive to the sun. It may||
0711|162|P|also increase your risk for skin cancer, especially if you take||
0711|163|P|it for a long time. Limit your time in the sun. Avoid tanning||
0711|164|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0711|165|P|when outdoors. Tell your doctor right away if you get sunburned,||
0711|166|P|have skin blisters/redness, or notice new or changed moles/skin||
0711|167|P|lesions.||
0711|168|P|   Older adults may be at greater risk for side effects while||
0711|169|P|using this drug.||
0711|170|P|   During pregnancy, this medication should be used only when||
0711|171|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0711|172|P|benefits with your doctor.||
0711|173|P|   This medication passes into breast milk and may have||
0711|174|P|undesirable effects on a nursing infant. Consult your doctor||
0711|175|P|before breastfeeding.||
0711|176|B|||
0711|177|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0711|178|I|medications work or increase your risk for serious side effects.||
0711|179|I|This document does not contain all possible drug interactions.||
0711|180|I|Keep a list of all the products you use (including||
0711|181|I|prescription/nonprescription drugs and herbal products) and share||
0711|182|I|it with your doctor and pharmacist. Do not start, stop, or change||
0711|183|I|the dosage of any medicines without your doctor's approval.||
0711|184|I|   Some products that may interact with this drug include:||
0711|185|I|clonidine, dofetilide, epinephrine, fingolimod, lithium,||
0711|186|I|thioridazine.||
0711|187|I|   Some products have ingredients that could raise your blood||
0711|188|I|pressure. Tell your pharmacist what products you are using, and||
0711|189|I|ask how to use them safely (especially cough-and-cold products,||
0711|190|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0711|191|I|   This product can affect the results of certain lab tests (such||
0711|192|I|as parathyroid, protein-bound iodide, tyramine and phentolamine||
0711|193|I|tests). Make sure lab personnel and all your doctors know you use||
0711|194|I|this drug.||
0711|195|B|||
0711|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0711|197|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0711|198|O|poison control center right away. US residents can call||
0711|199|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0711|200|O|Symptoms of overdose may include: very slow heartbeat, severe||
0711|201|O|dizziness, fainting, severe weakness, trouble breathing.||
0711|202|B|||
0711|203|N|NOTES:  Do not share this medication with others.||
0711|204|N|   Talk with your doctor about making changes to your lifestyle||
0711|205|N|that may increase the effectiveness of this medication (such as||
0711|206|N|stress reduction programs, exercise, and dietary changes).||
0711|207|N|   Lab and/or medical tests (such as potassium levels, liver||
0711|208|N|function, complete blood counts, skin exams, cholesterol levels)||
0711|209|N|should be done while you are taking this medication. Keep all||
0711|210|N|medical and lab appointments. Consult your doctor for more||
0711|211|N|details.||
0711|212|N|   Have your blood pressure checked regularly while taking this||
0711|213|N|medication. Learn how to monitor your own blood pressure at home,||
0711|214|N|and share the results with your doctor.||
0711|215|B|||
0711|216|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0711|217|D|remember. If it is near the time of the next dose, skip the||
0711|218|D|missed dose. Take your next dose at the regular time. Do not||
0711|219|D|double the dose to catch up.||
0711|220|B|||
0711|221|R|STORAGE:  Store at room temperature away from light and moisture.||
0711|222|R|Do not store in the bathroom. Keep all medications away from||
0711|223|R|children and pets.||
0711|224|R|   Do not flush medications down the toilet or pour them into a||
0711|225|R|drain unless instructed to do so. Properly discard this product||
0711|226|R|when it is expired or no longer needed. Consult your pharmacist||
0711|227|R|or local waste disposal company.||
0711|228|B|||
0711|229|A|Information last revised April 2025.||
0711|230|A|Copyright(c) 2025 First Databank, Inc.||
0711|231|B|||
0712|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0712|002|Z|does NOT have all possible information about this product. This||
0712|003|Z|information does not assure that this product is safe, effective,||
0712|004|Z|or appropriate for you. This information is not individual||
0712|005|Z|medical advice and does not substitute for the advice of your||
0712|006|Z|health care professional. Always ask your health care||
0712|007|Z|professional for complete information about this product and your||
0712|008|Z|specific health needs.||
0712|009|B|||
0712|010|T|MINOCYCLINE EXTENDED-RELEASE - ORAL||
0712|011|F|(MIN-oh-SYE-kleen)||
0712|012|B|||
0712|013|C|COMMON BRAND NAME(S): Minolira, Solodyn, Ximino||
0712|014|B|||
0712|015|U|USES:  This medication is used to treat moderate to severe acne||
0712|016|U|in people 12 years and older. It helps to reduce the number of||
0712|017|U|pimples. Minocycline belongs to a class of drugs known as||
0712|018|U|tetracycline antibiotics. It works by stopping the growth of||
0712|019|U|bacteria that may make acne worse.||
0712|020|U|   This antibiotic treats acne that is thought to be caused by a||
0712|021|U|bacterial infection. It will not work for viral infections (such||
0712|022|U|as common cold, flu). Using any antibiotic when it is not needed||
0712|023|U|can cause it to not work for future infections.||
0712|024|B|||
0712|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0712|026|H|from your pharmacist before you start taking minocycline and each||
0712|027|H|time you get a refill. If you have any questions, ask your doctor||
0712|028|H|or pharmacist.||
0712|029|H|   Take this medication by mouth with or without food as directed||
0712|030|H|by your doctor, usually once a day. Swallow this medication||
0712|031|H|whole. Do not crush or chew. Doing so can release all of the drug||
0712|032|H|at once, increasing the risk of side effects.||
0712|033|H|   Take each dose with a full glass of water (8 ounces/240||
0712|034|H|milliliters) unless your doctor directs you otherwise. Do not lie||
0712|035|H|down for at least 10 minutes after taking this medication. For||
0712|036|H|this reason, do not take it right before bedtime. You may take||
0712|037|H|this medication with food to lessen the chance of irritating the||
0712|038|H|esophagus or stomach unless your doctor directs you otherwise.||
0712|039|H|   Take this medication 2 to 3 hours before or after taking any||
0712|040|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
0712|041|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
0712|042|H|sucralfate, vitamins/minerals, dairy products (such as milk,||
0712|043|H|yogurt), and juice with added calcium. These products bind with||
0712|044|H|minocycline, preventing your body from fully absorbing the drug.||
0712|045|H|   The dosage and length of treatment are based on your medical||
0712|046|H|condition, weight, and response to treatment.||
0712|047|H|   For the best effect, take this antibiotic at evenly spaced||
0712|048|H|times. To help you remember, take this medication at the same||
0712|049|H|time every day.||
0712|050|H|   Continue to take this medication for the prescribed length of||
0712|051|H|time. Do not skip doses. Stopping the medication too early or||
0712|052|H|skipping doses may allow bacteria to grow and make your treatment||
0712|053|H|work less well.||
0712|054|H|   Tell your doctor if your condition does not get better or if||
0712|055|H|it gets worse.||
0712|056|B|||
0712|057|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, lightheadedness,||
0712|058|S|dizziness, or a feeling of spinning may occur. If any of these||
0712|059|S|effects last or get worse, tell your doctor or pharmacist||
0712|060|S|promptly.||
0712|061|S|   Remember that this medication has been prescribed because your||
0712|062|S|doctor has judged that the benefit to you is greater than the||
0712|063|S|risk of side effects. Many people using this medication do not||
0712|064|S|have serious side effects.||
0712|065|S|   Tell your doctor right away if you have any serious side||
0712|066|S|effects, including: painful/difficult swallowing, hearing changes||
0712|067|S|(such as ringing in the ears, decreased hearing), joint||
0712|068|S|stiffness/pain/swelling, signs of kidney problems (such as change||
0712|069|S|in the amount of urine, pink urine), signs of liver problems||
0712|070|S|(such as loss of appetite, stomach/abdominal pain, yellowing||
0712|071|S|eyes/skin, dark urine), yellow-gray-brown tooth discoloration,||
0712|072|S|blue-gray skin/tongue/lips/gums.||
0712|073|S|   Minocycline may rarely cause increased pressure around the||
0712|074|S|brain (intracranial hypertension-IH). The risk of this side||
0712|075|S|effect is greater for women of childbearing age who are||
0712|076|S|overweight or who have had IH in the past. If IH develops, it||
0712|077|S|usually goes away after minocycline is stopped; however, there is||
0712|078|S|a chance of permanent vision loss or blindness. Get medical help||
0712|079|S|right away if you have: severe/lasting headache, vision changes||
0712|080|S|(such as blurred/double vision, decreased vision, sudden||
0712|081|S|blindness), nausea/vomiting that doesn't stop.||
0712|082|S|   This medication may rarely cause a severe intestinal condition||
0712|083|S|due to a bacteria called C. difficile. This condition may occur||
0712|084|S|during treatment or weeks to months after treatment has stopped.||
0712|085|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0712|086|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0712|087|S|stool.||
0712|088|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0712|089|S|products because they may make symptoms worse.||
0712|090|S|   Use of this medication for prolonged or repeated periods may||
0712|091|S|result in oral thrush or a new yeast infection. Contact your||
0712|092|S|doctor if you notice white patches in your mouth, a change in||
0712|093|S|vaginal discharge, or other new symptoms.||
0712|094|S|   A very serious allergic reaction to this drug is rare.||
0712|095|S|However, get medical help right away if you notice any symptoms||
0712|096|S|of a serious allergic reaction, including: fever that doesn't go||
0712|097|S|away, new or worsening lymph node swelling, rash,||
0712|098|S|itching/swelling (especially of the face/tongue/throat), severe||
0712|099|S|dizziness, trouble breathing.||
0712|100|S|   This is not a complete list of possible side effects. If you||
0712|101|S|notice other effects not listed above, contact your doctor or||
0712|102|S|pharmacist.||
0712|103|S|   In the US -||
0712|104|S|   Call your doctor for medical advice about side effects. You||
0712|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0712|106|S|www.fda.gov/medwatch.||
0712|107|S|   In Canada - Call your doctor for medical advice about side||
0712|108|S|effects. You may report side effects to Health Canada at||
0712|109|S|1-866-234-2345.||
0712|110|B|||
0712|111|P|PRECAUTIONS:  See also Side Effects section.||
0712|112|P|   Before taking minocycline, tell your doctor or pharmacist if||
0712|113|P|you are allergic to it; or to other tetracyclines (such as||
0712|114|P|doxycycline); or if you have any other allergies. This product||
0712|115|P|may contain inactive ingredients, which can cause allergic||
0712|116|P|reactions or other problems. Talk to your pharmacist for more||
0712|117|P|details.||
0712|118|P|   Before using this medication, tell your doctor or pharmacist||
0712|119|P|your medical history, especially of: kidney problems, liver||
0712|120|P|problems, trouble swallowing, esophagus problems (such as hiatal||
0712|121|P|hernia or reflux/heartburn).||
0712|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0712|123|P|can make you more dizzy. Do not drive, use machinery, or do||
0712|124|P|anything that needs alertness until you can do it safely. Limit||
0712|125|P|alcoholic beverages. Talk to your doctor if you are using||
0712|126|P|marijuana (cannabis).||
0712|127|P|   This medication may make you more sensitive to the sun. Limit||
0712|128|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0712|129|P|sunscreen and wear protective clothing when outdoors. Tell your||
0712|130|P|doctor right away if you get sunburned or have skin||
0712|131|P|blisters/redness.||
0712|132|P|   Minocycline may cause live bacterial vaccines (such as typhoid||
0712|133|P|vaccine) to not work well. Tell your health care professional||
0712|134|P|that you are using minocycline before having any||
0712|135|P|immunizations/vaccinations.||
0712|136|P|   Before having surgery, tell your doctor or dentist about all||
0712|137|P|the products you use (including prescription drugs,||
0712|138|P|nonprescription drugs, and herbal products).||
0712|139|P|   Children younger than 8 years may be more sensitive to the||
0712|140|P|side effects of minocycline, especially tooth discoloration.||
0712|141|P|Tooth discoloration has also occurred in older children and in||
0712|142|P|young adults. Discuss the risks and benefits of this medication||
0712|143|P|with the doctor.||
0712|144|P|   Tell your doctor if you are pregnant or plan to become||
0712|145|P|pregnant. You should not become pregnant while using minocycline.||
0712|146|P|Minocycline may harm an unborn baby. If you become pregnant, talk||
0712|147|P|to your doctor right away about the risks and benefits of this||
0712|148|P|medication.||
0712|149|P|   This medication passes into breast milk. Consult your doctor||
0712|150|P|before breastfeeding.||
0712|151|B|||
0712|152|I|DRUG INTERACTIONS:  See also How to Use section.||
0712|153|I|   Drug interactions may change how your medications work or||
0712|154|I|increase your risk for serious side effects. This document does||
0712|155|I|not contain all possible drug interactions. Keep a list of all||
0712|156|I|the products you use (including prescription/nonprescription||
0712|157|I|drugs and herbal products) and share it with your doctor and||
0712|158|I|pharmacist. Do not start, stop, or change the dosage of any||
0712|159|I|medicines without your doctor's approval.||
0712|160|I|   Some products that may interact with this drug are: retinoid||
0712|161|I|medications taken by mouth (such as acitretin, isotretinoin),||
0712|162|I|strontium.||
0712|163|I|   This medication may interfere with certain lab tests (such as||
0712|164|I|urine catecholamine levels), possibly causing false test results.||
0712|165|I|Make sure lab personnel and all your doctors know you use this||
0712|166|I|drug.||
0712|167|B|||
0712|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0712|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0712|170|O|poison control center right away. US residents can call||
0712|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0712|172|B|||
0712|173|N|NOTES:  Do not share this medication with others.||
0712|174|N|   This medication has been prescribed for your current condition||
0712|175|N|only. Do not use it later for another infection unless your||
0712|176|N|doctor tells you to.||
0712|177|N|   Lab and/or medical tests (such as complete blood count,||
0712|178|N|kidney/liver function) may be done while you are taking this||
0712|179|N|medication. Keep all medical and lab appointments.||
0712|180|B|||
0712|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0712|182|D|remember. If it is near the time of the next dose, skip the||
0712|183|D|missed dose. Take your next dose at the regular time. Do not||
0712|184|D|double the dose to catch up.||
0712|185|B|||
0712|186|R|STORAGE:  Store at room temperature away from light and moisture.||
0712|187|R|Do not store in the bathroom. Keep all medications away from||
0712|188|R|children and pets.||
0712|189|R|   Do not flush medications down the toilet or pour them into a||
0712|190|R|drain unless instructed to do so. Properly discard this product||
0712|191|R|when it is expired or no longer needed. Taking expired||
0712|192|R|minocycline can cause serious illness. Consult your pharmacist or||
0712|193|R|local waste disposal company.||
0712|194|B|||
0712|195|A|Information last revised September 2025.||
0712|196|A|Copyright(c) 2025 First Databank, Inc.||
0712|197|B|||
0713|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0713|002|Z|does NOT have all possible information about this product. This||
0713|003|Z|information does not assure that this product is safe, effective,||
0713|004|Z|or appropriate for you. This information is not individual||
0713|005|Z|medical advice and does not substitute for the advice of your||
0713|006|Z|health care professional. Always ask your health care||
0713|007|Z|professional for complete information about this product and your||
0713|008|Z|specific health needs.||
0713|009|B|||
0713|010|T|MEDROXYPROGESTERONE 100 MG TABLET - ORAL||
0713|011|F|(meh-DROX-ee-pro-JESS-tur-own)||
0713|012|B|||
0713|013|W|WARNING:  Very serious side effects have been reported in women||
0713|014|W|after menopause who have used medroxyprogesterone along with||
0713|015|W|another drug (estrogen) during combination hormone replacement||
0713|016|W|therapy. Treatment can rarely cause heart disease (for example,||
0713|017|W|heart attacks), stroke, serious blood clots (possibly in the||
0713|018|W|lungs and legs), dementia, and breast cancer. These risks appear||
0713|019|W|to depend on the length of treatment and other factors.||
0713|020|W|Combination hormone therapy should be used for the shortest||
0713|021|W|possible length of time at the lowest effective dose so that the||
0713|022|W|benefits are obtained while the chance of serious side effects||
0713|023|W|from long-term treatment is minimized. Discuss the risks and||
0713|024|W|benefits of this drug during your cancer treatment with your||
0713|025|W|doctor.||
0713|026|W|   If you use this medication for an extended period, you should||
0713|027|W|have a complete physical exam at regular intervals (for example,||
0713|028|W|once a year) or as directed by your doctor. See also Notes||
0713|029|W|section.||
0713|030|B|||
0713|031|U|USES:  Medroxyprogesterone is a type of hormone (progestin). This||
0713|032|U|medication is similar to the progesterone that your body||
0713|033|U|naturally makes. It is used to treat cancer of the uterus lining||
0713|034|U|(endometrial cancer). It is also used to treat certain types of||
0713|035|U|breast cancer in women after menopause. Medroxyprogesterone helps||
0713|036|U|to slow down the growth of the tumors.||
0713|037|B|||
0713|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0713|039|H|from your pharmacist before you start using this drug and each||
0713|040|H|time you get a refill. If you have any questions, ask your doctor||
0713|041|H|or pharmacist.||
0713|042|H|   Take this medication by mouth as directed by your doctor. The||
0713|043|H|dosage is based on your medical condition and response to||
0713|044|H|treatment.||
0713|045|H|   Do not increase your dose or take this medication more often||
0713|046|H|than prescribed. Your condition will not improve any faster, and||
0713|047|H|the risk of serious side effects may be increased.||
0713|048|H|   It may take up to 2 to 3 months to see a response to this||
0713|049|H|medication.||
0713|050|B|||
0713|051|S|SIDE EFFECTS:  See also Warning section.||
0713|052|S|   Nausea, bloating, increased appetite, breast||
0713|053|S|tenderness/swelling, headache, change in vaginal discharge, mood||
0713|054|S|swings, dizziness, drowsiness, or weight gain may occur. If any||
0713|055|S|of these effects last or get worse, notify your doctor or||
0713|056|S|pharmacist promptly.||
0713|057|S|   Remember that this medication has been prescribed because your||
0713|058|S|doctor has judged that the benefit to you is greater than the||
0713|059|S|risk of side effects. Many people using this medication do not||
0713|060|S|have serious side effects.||
0713|061|S|   Tell your doctor right away if you have any serious side||
0713|062|S|effects, including: unusual vaginal bleeding (such as spotting,||
0713|063|S|breakthrough bleeding), mental/mood changes (such as depression,||
0713|064|S|memory loss), swelling of the hands/feet, unusual fullness of the||
0713|065|S|face, frequent/burning/painful urination, breast lumps, dark||
0713|066|S|patches on the skin or face (melasma), yellowing eyes/skin,||
0713|067|S|unusual tiredness.||
0713|068|S|   This medication, especially when used along with an estrogen||
0713|069|S|product, may rarely cause very serious (possibly fatal) problems||
0713|070|S|from blood clots (such as heart attack, stroke, blood clots in||
0713|071|S|the lungs, legs, or eyes). Get medical help right away if you||
0713|072|S|have: chest/jaw/left arm pain, weakness on one side of the body,||
0713|073|S|trouble speaking, sudden vision changes, confusion, sudden/severe||
0713|074|S|headaches, sudden dizziness/fainting, shortness of breath/rapid||
0713|075|S|breathing, pain/swelling/warmth in the groin/calf, unusual||
0713|076|S|sweating.||
0713|077|S|   A very serious allergic reaction to this drug is rare.||
0713|078|S|However, get medical right away if you notice any symptoms of a||
0713|079|S|serious allergic reaction, including: rash, itching/swelling||
0713|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0713|081|S|breathing.||
0713|082|S|   This is not a complete list of possible side effects. If you||
0713|083|S|notice other effects not listed above, contact your doctor or||
0713|084|S|pharmacist.||
0713|085|S|   In the US -||
0713|086|S|   Call your doctor for medical advice about side effects. You||
0713|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0713|088|S|www.fda.gov/medwatch.||
0713|089|S|   In Canada - Call your doctor for medical advice about side||
0713|090|S|effects. You may report side effects to Health Canada at||
0713|091|S|1-866-234-2345.||
0713|092|B|||
0713|093|P|PRECAUTIONS:  See also Warning section.||
0713|094|P|   Before taking medroxyprogesterone, tell your doctor or||
0713|095|P|pharmacist if you are allergic to it; or if you have any other||
0713|096|P|allergies. This product may contain inactive ingredients (such as||
0713|097|P|soybeans), which can cause allergic reactions or other problems.||
0713|098|P|Some people who are allergic to peanuts may also be allergic to||
0713|099|P|soy. Talk to your pharmacist for more details.||
0713|100|P|   Before using this medication, tell your doctor or pharmacist||
0713|101|P|your medical history, especially of: blood clots, bleeding in the||
0713|102|P|brain, liver disease, vaginal bleeding of unknown cause, a loss||
0713|103|P|of pregnancy with some tissue remaining in the uterus ("missed||
0713|104|P|abortion"), family medical history (especially breast lumps and||
0713|105|P|cancer), kidney disease, obesity, heart disease (such as past||
0713|106|P|heart attacks, coronary artery disease, heart failure), high||
0713|107|P|blood pressure, seizures, migraine headaches, asthma, high blood||
0713|108|P|levels of cholesterol/fats, high blood levels of calcium, a||
0713|109|P|certain blood disorder (porphyria), depression, strokes, vision||
0713|110|P|loss caused by blood vessel disease in the eye, smoking.||
0713|111|P|   If you have diabetes, this medication may make it harder to||
0713|112|P|control your blood sugar levels. Monitor your blood sugar||
0713|113|P|regularly as directed by your doctor. Tell your doctor the||
0713|114|P|results and if you have any symptoms of high blood sugar such as||
0713|115|P|increased thirst/urination. Your anti-diabetic medication or diet||
0713|116|P|may need to be adjusted.||
0713|117|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0713|118|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0713|119|P|machinery, or do anything that needs alertness until you can do||
0713|120|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0713|121|P|are using marijuana (cannabis).||
0713|122|P|   Before having surgery, tell your doctor or dentist about all||
0713|123|P|the products you use (including prescription drugs,||
0713|124|P|nonprescription drugs, and herbal products).||
0713|125|P|   This medication may cause blotchy, dark areas on your face and||
0713|126|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0713|127|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0713|128|P|wear protective clothing when outdoors.||
0713|129|P|   This medication should not be used during pregnancy. If you||
0713|130|P|become pregnant or think you may be pregnant, tell your doctor||
0713|131|P|right away.||
0713|132|P|   This drug passes into breast milk. Consult your doctor before||
0713|133|P|breastfeeding.||
0713|134|B|||
0713|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0713|136|I|medications work or increase your risk for serious side effects.||
0713|137|I|This document does not contain all possible drug interactions.||
0713|138|I|Keep a list of all the products you use (including||
0713|139|I|prescription/nonprescription drugs and herbal products) and share||
0713|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
0713|141|I|the dosage of any medicines without your doctor's approval.||
0713|142|I|   A product that may interact with this drug is:||
0713|143|I|aminoglutethimide.||
0713|144|I|   Other medications can affect the removal of||
0713|145|I|medroxyprogesterone from your body, which may affect how||
0713|146|I|medroxyprogesterone works. Examples include rifamycins (such as||
0713|147|I|rifampin), St. John's wort, drugs used to treat seizures (such as||
0713|148|I|carbamazepine, phenobarbital, phenytoin).||
0713|149|I|   This medication may interfere with certain lab tests, possibly||
0713|150|I|causing false test results. Make sure lab personnel and all your||
0713|151|I|doctors know you use this drug.||
0713|152|B|||
0713|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0713|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0713|155|O|poison control center right away. US residents can call||
0713|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0713|157|O|Symptoms of overdose may include severe nausea and vomiting.||
0713|158|B|||
0713|159|N|NOTES:  Do not share this medication with others.||
0713|160|N|   Regular complete physical exams which include lab and/or||
0713|161|N|medical tests (such as blood pressure, breast exam/mammogram,||
0713|162|N|pelvic exam, Pap smear) should be done while you are taking this||
0713|163|N|medication. Follow your doctor's instructions for examining your||
0713|164|N|breasts, and report any lumps right away. Keep all medical and||
0713|165|N|lab appointments. Consult your doctor for more details.||
0713|166|B|||
0713|167|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0713|168|D|remember. If it is near the time of the next dose, skip the||
0713|169|D|missed dose. Take your next dose at the regular time. Do not||
0713|170|D|double the dose to catch up.||
0713|171|B|||
0713|172|R|STORAGE:  Store at room temperature away from light and moisture.||
0713|173|R|Do not store in the bathroom. Keep all medications away from||
0713|174|R|children and pets.||
0713|175|R|   Do not flush medications down the toilet or pour them into a||
0713|176|R|drain unless instructed to do so. Properly discard this product||
0713|177|R|when it is expired or no longer needed. Consult your pharmacist||
0713|178|R|or local waste disposal company.||
0713|179|B|||
0713|180|A|Information last revised July 2024.||
0713|181|A|Copyright(c) 2025 First Databank, Inc.||
0713|182|B|||
0714|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0714|002|Z|does NOT have all possible information about this product. This||
0714|003|Z|information does not assure that this product is safe, effective,||
0714|004|Z|or appropriate for you. This information is not individual||
0714|005|Z|medical advice and does not substitute for the advice of your||
0714|006|Z|health care professional. Always ask your health care||
0714|007|Z|professional for complete information about this product and your||
0714|008|Z|specific health needs.||
0714|009|B|||
0714|010|T|CHOLESTYRAMINE - ORAL||
0714|011|F|(KOE-le-STYE-ra-meen)||
0714|012|B|||
0714|013|C|COMMON BRAND NAME(S): Prevalite, Questran||
0714|014|B|||
0714|015|U|USES:  Cholestyramine is used along with a proper diet to lower||
0714|016|U|cholesterol in the blood. Lowering cholesterol helps decrease the||
0714|017|U|risk for strokes and heart attacks.||
0714|018|U|   In addition to a proper diet (such as a||
0714|019|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
0714|020|U|help this medication work better include exercising, losing||
0714|021|U|weight if overweight, and stopping smoking. Consult your doctor||
0714|022|U|for more details.||
0714|023|U|   Cholestyramine may also be used to treat itching in people||
0714|024|U|with too much bile acid caused by a certain type of liver/bile||
0714|025|U|duct disease (partial biliary obstruction).||
0714|026|U|   This medication is known as a bile acid-binding resin. It||
0714|027|U|works by removing bile acid from the body. In people with high||
0714|028|U|cholesterol, this causes the liver to make more bile acid by||
0714|029|U|using cholesterol in the blood. This helps to lower the||
0714|030|U|cholesterol levels.||
0714|031|B|||
0714|032|H|HOW TO USE:  Take this medication by mouth as directed by your||
0714|033|H|doctor, usually 1 to 2 times a day. This medication comes as a||
0714|034|H|powder with doses measured by the scoopful (using the provided||
0714|035|H|scoop) or in individual dose packets. Do not take your dose in||
0714|036|H|the dry powder form. Mix the medication in at least 2 to 6 ounces||
0714|037|H|(60 to 180 milliliters) of liquid (such as water, milk, fruit||
0714|038|H|juice), stir completely, and drink right away. Rinse your glass||
0714|039|H|with more liquid and drink the rinse liquid to be sure that you||
0714|040|H|have taken the entire dose. You may also mix this medication with||
0714|041|H|watery soups, applesauce, or a pulpy fruit which has a lot of||
0714|042|H|juice (such as crushed pineapple, peaches).||
0714|043|H|   Do not hold the mixture in your mouth for long since doing so||
0714|044|H|can damage your teeth. Practice good dental habits (such as||
0714|045|H|brushing and flossing your teeth regularly).||
0714|046|H|   The dosage is based on your medical condition and response to||
0714|047|H|treatment. To reduce your risk of side effects, your doctor may||
0714|048|H|direct you to start this medication at a low dose and gradually||
0714|049|H|increase your dose. Follow your doctor's instructions carefully.||
0714|050|H|It may take several weeks before you get the full benefit of this||
0714|051|H|drug.||
0714|052|H|   Cholestyramine may decrease your absorption of other||
0714|053|H|medications. Take your other medications as directed by your||
0714|054|H|doctor, usually at least 1 hour before or 4 to 6 hours after||
0714|055|H|cholestyramine. Ask your doctor or pharmacist for more||
0714|056|H|information or if you have any questions.||
0714|057|H|   Take this medication regularly in order to get the most||
0714|058|H|benefit from it. To help you remember, take it at the same||
0714|059|H|time(s) each day. Keep taking this medication even if you feel||
0714|060|H|well. Most people with high cholesterol do not feel sick.||
0714|061|B|||
0714|062|S|SIDE EFFECTS:  Constipation, stomach/abdominal pain, gas, nausea,||
0714|063|S|and vomiting may occur. If any of these effects last or get||
0714|064|S|worse, tell your doctor or pharmacist promptly.||
0714|065|S|   To prevent constipation, eat dietary fiber, drink enough||
0714|066|S|water, and exercise. You may also need to take a laxative. Ask||
0714|067|S|your pharmacist which type of laxative is right for you.||
0714|068|S|   Remember that this medication has been prescribed because your||
0714|069|S|doctor has judged that the benefit to you is greater than the||
0714|070|S|risk of side effects. Many people using this medication do not||
0714|071|S|have serious side effects.||
0714|072|S|   Tell your doctor right away if you have any serious side||
0714|073|S|effects, including: severe stomach/abdominal pain, unusual||
0714|074|S|bleeding/bruising, rapid breathing, confusion.||
0714|075|S|   A very serious allergic reaction to this drug is rare.||
0714|076|S|However, get medical help right away if you notice any symptoms||
0714|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0714|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0714|079|S|breathing.||
0714|080|S|   This is not a complete list of possible side effects. If you||
0714|081|S|notice other effects not listed above, contact your doctor or||
0714|082|S|pharmacist.||
0714|083|S|   In the US -||
0714|084|S|   Call your doctor for medical advice about side effects. You||
0714|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0714|086|S|www.fda.gov/medwatch.||
0714|087|S|   In Canada - Call your doctor for medical advice about side||
0714|088|S|effects. You may report side effects to Health Canada at||
0714|089|S|1-866-234-2345.||
0714|090|B|||
0714|091|P|PRECAUTIONS:  Before taking cholestyramine, tell your doctor or||
0714|092|P|pharmacist if you are allergic to it; or if you have any other||
0714|093|P|allergies. This product may contain inactive ingredients, which||
0714|094|P|can cause allergic reactions or other problems. Talk to your||
0714|095|P|pharmacist for more details.||
0714|096|P|   Before using this medication, tell your doctor or pharmacist||
0714|097|P|your medical history, especially of: constipation, hemorrhoids,||
0714|098|P|kidney disease.||
0714|099|P|   Some products may contain sugar or aspartame. Caution is||
0714|100|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
0714|101|P|condition that requires you to limit/avoid these substances in||
0714|102|P|your diet. Ask your doctor or pharmacist about using this product||
0714|103|P|safely.||
0714|104|P|   Because this drug can interfere with the absorption of certain||
0714|105|P|nutrients (such as folic acid, fat-soluble vitamins including A,||
0714|106|P|D, E, K), your doctor may direct you to take a multivitamin||
0714|107|P|supplement. Consult your doctor for more information.||
0714|108|P|   Before having surgery, tell your doctor or dentist about all||
0714|109|P|the products you use (including prescription drugs,||
0714|110|P|nonprescription drugs, and herbal products).||
0714|111|P|   Older adults may be more sensitive to the side effects of this||
0714|112|P|drug, especially constipation.||
0714|113|P|   During pregnancy, this medication should be used only when||
0714|114|P|clearly needed. It may affect the absorption of certain||
0714|115|P|nutrients. Discuss the risks and benefits with your doctor.||
0714|116|P|   This medication is unlikely to pass into breast milk. However,||
0714|117|P|it may affect the absorption of certain nutrients. Consult your||
0714|118|P|doctor before breastfeeding.||
0714|119|B|||
0714|120|I|DRUG INTERACTIONS:  See also How to Use section.||
0714|121|I|   Drug interactions may change how your medications work or||
0714|122|I|increase your risk for serious side effects. This document does||
0714|123|I|not contain all possible drug interactions. Keep a list of all||
0714|124|I|the products you use (including prescription/nonprescription||
0714|125|I|drugs and herbal products) and share it with your doctor and||
0714|126|I|pharmacist. Do not start, stop, or change the dosage of any||
0714|127|I|medicines without your doctor's approval.||
0714|128|I|   Some products that may interact with this drug include: "blood||
0714|129|I|thinners" (such as warfarin), mycophenolate, raloxifene.||
0714|130|B|||
0714|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0714|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0714|133|O|poison control center right away. US residents can call||
0714|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0714|135|O|Symptoms of overdose may include: severe stomach/abdominal pain.||
0714|136|B|||
0714|137|N|NOTES:  Do not share this medication with others.||
0714|138|N|   Lab and/or medical tests (such as blood||
0714|139|N|cholesterol/triglyceride levels, vitamin levels) should be done||
0714|140|N|while you are taking this medication. Keep all medical and lab||
0714|141|N|appointments. Consult your doctor for more details.||
0714|142|B|||
0714|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0714|144|D|remember. If it is near the time of the next dose, skip the||
0714|145|D|missed dose. Take your next dose at the regular time. Do not||
0714|146|D|double the dose to catch up.||
0714|147|B|||
0714|148|R|STORAGE:  Store at room temperature away from light and moisture.||
0714|149|R|The color of the medication may sometimes vary. This is normal||
0714|150|R|and will not affect how the drug works. If you have any questions||
0714|151|R|about storage, ask your pharmacist. Do not store the medication||
0714|152|R|in the bathroom. Keep all medications away from children and||
0714|153|R|pets.||
0714|154|R|   Do not flush medications down the toilet or pour them into a||
0714|155|R|drain unless instructed to do so. Properly discard this product||
0714|156|R|when it is expired or no longer needed. Consult your pharmacist||
0714|157|R|or local waste disposal company.||
0714|158|B|||
0714|159|A|Information last revised May 2024.||
0714|160|A|Copyright(c) 2025 First Databank, Inc.||
0714|161|B|||
0716|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0716|002|Z|does NOT have all possible information about this product. This||
0716|003|Z|information does not assure that this product is safe, effective,||
0716|004|Z|or appropriate for you. This information is not individual||
0716|005|Z|medical advice and does not substitute for the advice of your||
0716|006|Z|health care professional. Always ask your health care||
0716|007|Z|professional for complete information about this product and your||
0716|008|Z|specific health needs.||
0716|009|B|||
0716|010|T|CLOCORTOLONE - TOPICAL||
0716|011|F|(kloe-KOR-toe-lone)||
0716|012|B|||
0716|013|C|COMMON BRAND NAME(S): Cloderm||
0716|014|B|||
0716|015|U|USES:  This medication is used to treat a variety of skin||
0716|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0716|017|U|Clocortolone reduces the swelling, itching, and redness that can||
0716|018|U|occur in these types of conditions. This medication is a||
0716|019|U|medium-strength corticosteroid.||
0716|020|B|||
0716|021|H|HOW TO USE:  Use this medication on the skin only. However, do||
0716|022|H|not use it on the face, groin, or underarms unless directed to do||
0716|023|H|so by your doctor.||
0716|024|H|   Wash and dry your hands before using. Clean and dry the||
0716|025|H|affected area. Apply a thin film of medication to the affected||
0716|026|H|area and gently rub in as directed by your doctor, usually 3||
0716|027|H|times daily. Do not bandage, cover, or wrap the area unless||
0716|028|H|directed to do so by your doctor.||
0716|029|H|   After applying the medication, wash your hands unless you are||
0716|030|H|using this medication to treat the hands. When applying this||
0716|031|H|medication near the eyes, avoid getting it in the eyes because||
0716|032|H|this may worsen or cause glaucoma. Also, avoid getting this||
0716|033|H|medication in the nose or mouth. If you get the medication in||
0716|034|H|these areas, rinse with plenty of water.||
0716|035|H|   Use this medication only for the condition for which it was||
0716|036|H|prescribed. Do not use it for longer than prescribed.||
0716|037|H|   Tell your doctor if your condition lasts or gets worse after 2||
0716|038|H|weeks.||
0716|039|B|||
0716|040|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
0716|041|S|or redness at the application site may occur when this medication||
0716|042|S|is first applied to the skin. These effects should disappear in a||
0716|043|S|few days as your body adjusts to the medication. If any of these||
0716|044|S|effects last or get worse, notify your doctor or pharmacist||
0716|045|S|promptly.||
0716|046|S|   Remember that this medication has been prescribed because your||
0716|047|S|doctor has judged that the benefit to you is greater than the||
0716|048|S|risk of side effects. Many people using this medication do not||
0716|049|S|have serious side effects.||
0716|050|S|   Tell your doctor right away if you have any serious side||
0716|051|S|effects, including: stretch marks, skin thinning/discoloration,||
0716|052|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0716|053|S|(folliculitis).||
0716|054|S|   Skin infections can become worse when this medication is used.||
0716|055|S|Notify your doctor promptly if redness, swelling, or irritation||
0716|056|S|does not improve.||
0716|057|S|   Rarely, it is possible this medication will be absorbed from||
0716|058|S|the skin into the bloodstream. This can lead to side effects of||
0716|059|S|too much corticosteroid. These side effects are more likely in||
0716|060|S|children, and in people who use this medication for a long time||
0716|061|S|or over large areas of the skin. Tell your doctor right away if||
0716|062|S|any of the following side effects occur: unusual/extreme||
0716|063|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0716|064|S|thirst/urination, vision problems.||
0716|065|S|   A very serious allergic reaction to this drug is rare.||
0716|066|S|However, get medical help right away if you notice any symptoms||
0716|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0716|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0716|069|S|breathing.||
0716|070|S|   This is not a complete list of possible side effects. If you||
0716|071|S|notice other effects not listed above, contact your doctor or||
0716|072|S|pharmacist.||
0716|073|S|   In the US -||
0716|074|S|   Call your doctor for medical advice about side effects. You||
0716|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0716|076|S|www.fda.gov/medwatch.||
0716|077|S|   In Canada - Call your doctor for medical advice about side||
0716|078|S|effects. You may report side effects to Health Canada at||
0716|079|S|1-866-234-2345.||
0716|080|B|||
0716|081|P|PRECAUTIONS:  Before using clocortolone, tell your doctor or||
0716|082|P|pharmacist if you are allergic to it; or to other corticosteroids||
0716|083|P|(such as hydrocortisone, prednisone); or if you have any other||
0716|084|P|allergies. This product may contain inactive ingredients, which||
0716|085|P|can cause allergic reactions or other problems. Talk to your||
0716|086|P|pharmacist for more details.||
0716|087|P|   Before using this medication, tell your doctor or pharmacist||
0716|088|P|your medical history, especially of: poor blood circulation,||
0716|089|P|immune system problems.||
0716|090|P|   Do not use if there is an infection or sore in the area to be||
0716|091|P|treated.||
0716|092|P|   Rarely, using corticosteroid medications for a long time or||
0716|093|P|over large areas of skin can make it more difficult for your body||
0716|094|P|to respond to physical stress. Before having surgery or emergency||
0716|095|P|treatment, or if you get a serious illness/injury, tell your||
0716|096|P|doctor or dentist that you are using this medication or have used||
0716|097|P|this medication within the past few months.||
0716|098|P|   Though it is unlikely, this medication may temporarily slow||
0716|099|P|down a child's growth if used for a long time. See the doctor||
0716|100|P|regularly so your child's height can be checked.||
0716|101|P|   During pregnancy, this medication should be used only when||
0716|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0716|103|P|   It is unknown if this drug passes into breast milk when||
0716|104|P|applied to the skin. Similar medications pass into breast milk||
0716|105|P|when taken by mouth. Consult your doctor before breastfeeding.||
0716|106|B|||
0716|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0716|108|I|medications work or increase your risk for serious side effects.||
0716|109|I|This document does not contain all possible drug interactions.||
0716|110|I|Keep a list of all the products you use (including||
0716|111|I|prescription/nonprescription drugs and herbal products) and share||
0716|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
0716|113|I|the dosage of any medicines without your doctor's approval.||
0716|114|B|||
0716|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0716|116|O|has overdosed and has serious symptoms such as passing out or||
0716|117|O|trouble breathing, call 911. Otherwise, call a poison control||
0716|118|O|center right away. US residents can call 1-800-222-1222. Canada||
0716|119|O|residents can call 1-844-764-7669.||
0716|120|B|||
0716|121|N|NOTES:  Do not share this medication with others.||
0716|122|N|   This medication has been prescribed for your current condition||
0716|123|N|only. Do not use it later for other skin problems unless told to||
0716|124|N|do so by your doctor. A different medication may be necessary in||
0716|125|N|those cases.||
0716|126|N|   Lab and/or medical tests (such as adrenal gland function) may||
0716|127|N|be done while you are using this medication, especially if you||
0716|128|N|use this drug for an extended period of time or apply it over||
0716|129|N|large areas of the body. Keep all medical and lab appointments.||
0716|130|N|Consult your doctor for more details.||
0716|131|B|||
0716|132|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0716|133|D|If it is near the time of the next dose, skip the missed dose.||
0716|134|D|Use your next dose at the regular time. Do not double the dose to||
0716|135|D|catch up.||
0716|136|B|||
0716|137|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
0716|138|R|medications away from children and pets.||
0716|139|R|   Do not flush medications down the toilet or pour them into a||
0716|140|R|drain unless instructed to do so. Properly discard this product||
0716|141|R|when it is expired or no longer needed. Consult your pharmacist||
0716|142|R|or local waste disposal company.||
0716|143|B|||
0716|144|A|Information last revised October 2024.||
0716|145|A|Copyright(c) 2025 First Databank, Inc.||
0716|146|B|||
0717|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0717|002|Z|does NOT have all possible information about this product. This||
0717|003|Z|information does not assure that this product is safe, effective,||
0717|004|Z|or appropriate for you. This information is not individual||
0717|005|Z|medical advice and does not substitute for the advice of your||
0717|006|Z|health care professional. Always ask your health care||
0717|007|Z|professional for complete information about this product and your||
0717|008|Z|specific health needs.||
0717|009|B|||
0717|010|T|AMCINONIDE - TOPICAL||
0717|011|F|(am-SIN-oh-nide)||
0717|012|B|||
0717|013|C|COMMON BRAND NAME(S): Cyclocort||
0717|014|B|||
0717|015|U|USES:  This medication is used to treat a variety of skin||
0717|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0717|017|U|Amcinonide reduces the swelling, itching, and redness that can||
0717|018|U|occur in these types of conditions. This medication is a strong||
0717|019|U|corticosteroid.||
0717|020|B|||
0717|021|H|HOW TO USE:  Use this medication on the skin only. However, do||
0717|022|H|not use it on the face, groin, or underarms unless directed to do||
0717|023|H|so by your doctor.||
0717|024|H|   Wash and dry your hands. Before applying the medication, clean||
0717|025|H|and dry the affected area. If you are using the lotion, shake the||
0717|026|H|bottle well before using. Apply a thin film of the medication to||
0717|027|H|the affected area and gently rub in as directed by your doctor,||
0717|028|H|usually 2 to 3 times daily. Do not cover, bandage, or wrap the||
0717|029|H|area unless directed to do so by your doctor.||
0717|030|H|   After applying the medication, wash your hands unless you are||
0717|031|H|using this medication to treat the hands. When applying this||
0717|032|H|medication near the eyes, avoid getting it in the eyes as this||
0717|033|H|may worsen or cause glaucoma. Also, avoid getting this medication||
0717|034|H|in the nose or mouth. If you get the medication in these areas,||
0717|035|H|rinse with plenty of water.||
0717|036|H|   Use this medication only for the condition for which it was||
0717|037|H|prescribed. Do not use it for longer than prescribed.||
0717|038|H|   Tell your doctor if your condition lasts or gets worse after 2||
0717|039|H|weeks.||
0717|040|B|||
0717|041|S|SIDE EFFECTS:  Burning, itching, irritation, or dryness at the||
0717|042|S|application site may occur when this medication is first applied||
0717|043|S|to the skin. This should disappear in a few days as your body||
0717|044|S|adjusts to the medication. If any of these effects last or get||
0717|045|S|worse, notify your doctor or pharmacist promptly.||
0717|046|S|   Remember that this medication has been prescribed because your||
0717|047|S|doctor has judged that the benefit to you is greater than the||
0717|048|S|risk of side effects. Many people using this medication do not||
0717|049|S|have serious side effects.||
0717|050|S|   Tell your doctor right away if you have any serious side||
0717|051|S|effects, including: stretch marks, skin thinning/discoloration,||
0717|052|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0717|053|S|(folliculitis).||
0717|054|S|   Skin infections can become worse when this medication is used.||
0717|055|S|Notify your doctor if redness, swelling, or irritation does not||
0717|056|S|improve.||
0717|057|S|   Rarely, it is possible this medication will be absorbed from||
0717|058|S|the skin into the bloodstream. This can lead to side effects of||
0717|059|S|too much corticosteroid. These side effects are more likely in||
0717|060|S|children, and in people who use this medication for a long time||
0717|061|S|or over large areas of the skin. Tell your doctor right away if||
0717|062|S|any of the following side effects occur: unusual/extreme||
0717|063|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0717|064|S|thirst/urination, vision problems.||
0717|065|S|   A very serious allergic reaction to this drug is rare.||
0717|066|S|However, get medical help right away if you notice any symptoms||
0717|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0717|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0717|069|S|breathing.||
0717|070|S|   This is not a complete list of possible side effects. If you||
0717|071|S|notice other effects not listed above, contact your doctor or||
0717|072|S|pharmacist.||
0717|073|S|   In the US -||
0717|074|S|   Call your doctor for medical advice about side effects. You||
0717|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0717|076|S|www.fda.gov/medwatch.||
0717|077|S|   In Canada - Call your doctor for medical advice about side||
0717|078|S|effects. You may report side effects to Health Canada at||
0717|079|S|1-866-234-2345.||
0717|080|B|||
0717|081|P|PRECAUTIONS:  Before using amcinonide, tell your doctor or||
0717|082|P|pharmacist if you are allergic to it; or to other corticosteroids||
0717|083|P|(such as hydrocortisone, prednisone); or if you have any other||
0717|084|P|allergies. This product may contain inactive ingredients, which||
0717|085|P|can cause allergic reactions or other problems. Talk to your||
0717|086|P|pharmacist for more details.||
0717|087|P|   Before using this medication, tell your doctor or pharmacist||
0717|088|P|your medical history, especially of: poor blood circulation,||
0717|089|P|immune system problems.||
0717|090|P|   Do not use if there is an infection or sore present in the||
0717|091|P|area to be treated.||
0717|092|P|   Rarely, using corticosteroid medications for a long time or||
0717|093|P|over large areas of skin can make it more difficult for your body||
0717|094|P|to respond to physical stress. Before having surgery or emergency||
0717|095|P|treatment, or if you get a serious illness/injury, tell your||
0717|096|P|doctor or dentist that you are using this medication or have used||
0717|097|P|this medication within the past few months.||
0717|098|P|   Though it is unlikely, this medication may temporarily slow||
0717|099|P|down a child's growth if used for a long time. See the doctor||
0717|100|P|regularly so your child's height can be checked.||
0717|101|P|   During pregnancy, this medication should be used only when||
0717|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0717|103|P|   It is unknown if this drug passes into breast milk when||
0717|104|P|applied to the skin. Similar medications pass into breast milk||
0717|105|P|when taken by mouth. Consult your doctor before breastfeeding.||
0717|106|B|||
0717|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0717|108|I|medications work or increase your risk for serious side effects.||
0717|109|I|This document does not contain all possible drug interactions.||
0717|110|I|Keep a list of all the products you use (including||
0717|111|I|prescription/nonprescription drugs and herbal products) and share||
0717|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
0717|113|I|the dosage of any medicines without your doctor's approval.||
0717|114|B|||
0717|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0717|116|O|has overdosed and has serious symptoms such as passing out or||
0717|117|O|trouble breathing, call 911. Otherwise, call a poison control||
0717|118|O|center right away. US residents can call 1-800-222-1222. Canada||
0717|119|O|residents can call 1-844-764-7669.||
0717|120|B|||
0717|121|N|NOTES:  Do not share this medication with others.||
0717|122|N|   This medication has been prescribed for your current condition||
0717|123|N|only. Do not use it later for other skin problems unless told to||
0717|124|N|do so by your doctor. A different medication may be necessary in||
0717|125|N|those cases.||
0717|126|N|   Lab and/or medical tests (such as adrenal gland function) may||
0717|127|N|be done while you are using this medication, especially if you||
0717|128|N|use this drug for an extended period of time or apply it over||
0717|129|N|large areas of the body. Keep all medical and lab appointments.||
0717|130|N|Consult your doctor for more details.||
0717|131|B|||
0717|132|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0717|133|D|If it is near the time of the next dose, skip the missed dose.||
0717|134|D|Use your next dose at the regular time. Do not double the dose to||
0717|135|D|catch up.||
0717|136|B|||
0717|137|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
0717|138|R|medications away from children and pets.||
0717|139|R|   Do not flush medications down the toilet or pour them into a||
0717|140|R|drain unless instructed to do so. Properly discard this product||
0717|141|R|when it is expired or no longer needed. Consult your pharmacist||
0717|142|R|or local waste disposal company.||
0717|143|B|||
0717|144|A|Information last revised October 2024.||
0717|145|A|Copyright(c) 2025 First Databank, Inc.||
0717|146|B|||
0718|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0718|002|Z|does NOT have all possible information about this product. This||
0718|003|Z|information does not assure that this product is safe, effective,||
0718|004|Z|or appropriate for you. This information is not individual||
0718|005|Z|medical advice and does not substitute for the advice of your||
0718|006|Z|health care professional. Always ask your health care||
0718|007|Z|professional for complete information about this product and your||
0718|008|Z|specific health needs.||
0718|009|B|||
0718|010|T|HYDROCORTISONE BUTYRATE - TOPICAL||
0718|011|F|(HYE-droe-KOR-ti-sone BUE-ti-rate)||
0718|012|B|||
0718|013|C|COMMON BRAND NAME(S): Locoid||
0718|014|B|||
0718|015|U|USES:  This medication is used to treat a variety of skin||
0718|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0718|017|U|Hydrocortisone butyrate reduces the swelling, itching, and||
0718|018|U|redness that can occur in these types of conditions. The topical||
0718|019|U|solution is used to treat severe dandruff (seborrheic||
0718|020|U|dermatitis). This medication is a medium-strength corticosteroid.||
0718|021|B|||
0718|022|H|HOW TO USE:  Use this medication on the skin only. However, do||
0718|023|H|not use it on the face, groin, or underarms unless directed to do||
0718|024|H|so by your doctor.||
0718|025|H|   Wash and dry your hands before using. Clean and dry the||
0718|026|H|affected area. Apply a thin film of medication to the affected||
0718|027|H|area and gently rub in. Apply the ointment, cream, or solution||
0718|028|H|form of this medication as directed by your doctor, usually 2 to||
0718|029|H|3 times daily. Apply the lotion form of this medication as||
0718|030|H|directed by your doctor, usually 2 times daily. Do not bandage,||
0718|031|H|cover, or wrap the area unless directed to do so by your doctor.||
0718|032|H|   After applying the medication, wash your hands unless you are||
0718|033|H|using this medication to treat the hands. When applying this||
0718|034|H|medication near the eyes, avoid getting it in the eyes because||
0718|035|H|this may worsen or cause glaucoma. Also, avoid getting this||
0718|036|H|medication in the nose or mouth. If you get the medication in||
0718|037|H|these areas, rinse with plenty of water.||
0718|038|H|   Use this medication only for the condition for which it was||
0718|039|H|prescribed. Do not use it for longer than prescribed.||
0718|040|H|   Tell your doctor if your condition lasts or gets worse after 2||
0718|041|H|weeks.||
0718|042|B|||
0718|043|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
0718|044|S|or redness at the application site may occur when this medication||
0718|045|S|is first applied to the skin. These effects should disappear in a||
0718|046|S|few days as your body adjusts to the medication. If any of these||
0718|047|S|effects last or get worse, notify your doctor or pharmacist||
0718|048|S|promptly.||
0718|049|S|   Remember that this medication has been prescribed because your||
0718|050|S|doctor has judged that the benefit to you is greater than the||
0718|051|S|risk of side effects. Many people using this medication do not||
0718|052|S|have serious side effects.||
0718|053|S|   Tell your doctor right away if you have any serious side||
0718|054|S|effects, including: stretch marks, skin thinning/discoloration,||
0718|055|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0718|056|S|(folliculitis).||
0718|057|S|   Skin infections can become worse when this medication is used.||
0718|058|S|Notify your doctor promptly if redness, swelling, or irritation||
0718|059|S|does not improve.||
0718|060|S|   Rarely, it is possible this medication will be absorbed from||
0718|061|S|the skin into the bloodstream. This can lead to side effects of||
0718|062|S|too much corticosteroid. These side effects are more likely in||
0718|063|S|children, and in people who use this medication for a long time||
0718|064|S|or over large areas of the skin. Tell your doctor right away if||
0718|065|S|any of the following side effects occur: unusual/extreme||
0718|066|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0718|067|S|thirst/urination, vision problems.||
0718|068|S|   A very serious allergic reaction to this drug is rare.||
0718|069|S|However, get medical help right away if you notice any symptoms||
0718|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0718|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0718|072|S|breathing.||
0718|073|S|   This is not a complete list of possible side effects. If you||
0718|074|S|notice other effects not listed above, contact your doctor or||
0718|075|S|pharmacist.||
0718|076|S|   In the US -||
0718|077|S|   Call your doctor for medical advice about side effects. You||
0718|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0718|079|S|www.fda.gov/medwatch.||
0718|080|S|   In Canada - Call your doctor for medical advice about side||
0718|081|S|effects. You may report side effects to Health Canada at||
0718|082|S|1-866-234-2345.||
0718|083|B|||
0718|084|P|PRECAUTIONS:  Before using hydrocortisone butyrate, tell your||
0718|085|P|doctor or pharmacist if you are allergic to it; or to other||
0718|086|P|corticosteroids (such as prednisone, triamcinolone); or if you||
0718|087|P|have any other allergies. This product may contain inactive||
0718|088|P|ingredients, which can cause allergic reactions or other||
0718|089|P|problems. Talk to your pharmacist for more details.||
0718|090|P|   Before using this medication, tell your doctor or pharmacist||
0718|091|P|your medical history, especially of: poor blood circulation,||
0718|092|P|diabetes, immune system problems.||
0718|093|P|   Do not use if there is an infection or sore in the area to be||
0718|094|P|treated.||
0718|095|P|   Rarely, using corticosteroid medications for a long time or||
0718|096|P|over large areas of skin can make it more difficult for your body||
0718|097|P|to respond to physical stress. Before having surgery or emergency||
0718|098|P|treatment, or if you get a serious illness/injury, tell your||
0718|099|P|doctor or dentist that you are using this medication or have used||
0718|100|P|this medication within the past few months.||
0718|101|P|   Though it is unlikely, this medication may temporarily slow||
0718|102|P|down a child's growth if used for a long time. See the doctor||
0718|103|P|regularly so your child's height can be checked.||
0718|104|P|   During pregnancy, this medication should be used only when||
0718|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
0718|106|P|   It is unknown if this drug passes into breast milk when||
0718|107|P|applied to the skin. Similar medications pass into breast milk||
0718|108|P|when taken by mouth. Consult your doctor before breastfeeding.||
0718|109|B|||
0718|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0718|111|I|medications work or increase your risk for serious side effects.||
0718|112|I|This document does not contain all possible drug interactions.||
0718|113|I|Keep a list of all the products you use (including||
0718|114|I|prescription/nonprescription drugs and herbal products) and share||
0718|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
0718|116|I|the dosage of any medicines without your doctor's approval.||
0718|117|B|||
0718|118|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0718|119|O|has overdosed and has serious symptoms such as passing out or||
0718|120|O|trouble breathing, call 911. Otherwise, call a poison control||
0718|121|O|center right away. US residents can call 1-800-222-1222. Canada||
0718|122|O|residents can call 1-844-764-7669.||
0718|123|B|||
0718|124|N|NOTES:  Do not share this medication with others.||
0718|125|N|   This medication has been prescribed for your current condition||
0718|126|N|only. Do not use it later for other skin problems unless told to||
0718|127|N|do so by your doctor. A different medication may be necessary in||
0718|128|N|those cases.||
0718|129|N|   Lab and/or medical tests (such as adrenal gland function) may||
0718|130|N|be done while you are using this medication, especially if you||
0718|131|N|use this drug for an extended period of time or apply it over||
0718|132|N|large areas of the body. Keep all medical and lab appointments.||
0718|133|N|Consult your doctor for more details.||
0718|134|B|||
0718|135|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0718|136|D|If it is near the time of the next dose, skip the missed dose.||
0718|137|D|Use your next dose at the regular time. Do not double the dose to||
0718|138|D|catch up.||
0718|139|B|||
0718|140|R|STORAGE:  Store at room temperature. Keep all medications away||
0718|141|R|from children and pets.||
0718|142|R|   Do not flush medications down the toilet or pour them into a||
0718|143|R|drain unless instructed to do so. Properly discard this product||
0718|144|R|when it is expired or no longer needed. Consult your pharmacist||
0718|145|R|or local waste disposal company.||
0718|146|B|||
0718|147|A|Information last revised October 2024.||
0718|148|A|Copyright(c) 2025 First Databank, Inc.||
0718|149|B|||
0719|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0719|002|Z|does NOT have all possible information about this product. This||
0719|003|Z|information does not assure that this product is safe, effective,||
0719|004|Z|or appropriate for you. This information is not individual||
0719|005|Z|medical advice and does not substitute for the advice of your||
0719|006|Z|health care professional. Always ask your health care||
0719|007|Z|professional for complete information about this product and your||
0719|008|Z|specific health needs.||
0719|009|B|||
0719|010|T|FLUOCINONIDE - TOPICAL||
0719|011|F|(FLOO-oh-SIN-oh-nide)||
0719|012|B|||
0719|013|C|COMMON BRAND NAME(S): Fluovix, Lidex, Vanos||
0719|014|B|||
0719|015|U|USES:  This medication is used to treat a variety of skin||
0719|016|U|conditions (such as eczema, dermatitis, psoriasis, allergies,||
0719|017|U|rash). Fluocinonide reduces the swelling, itching, and redness||
0719|018|U|that can occur in these types of conditions. This medication is a||
0719|019|U|strong corticosteroid.||
0719|020|B|||
0719|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0719|022|H|from your pharmacist before you start using fluocinonide and each||
0719|023|H|time you get a refill. If you have any questions, ask your doctor||
0719|024|H|or pharmacist.||
0719|025|H|   This medication is for use on the skin only. Do not use it on||
0719|026|H|the face, groin, or underarms unless directed to do so by your||
0719|027|H|doctor.||
0719|028|H|   Wash and dry your hands before applying the medication, then||
0719|029|H|clean and dry the affected area. Apply a thin film of the||
0719|030|H|medication to the affected area and gently rub in as directed by||
0719|031|H|your doctor, usually 1 to 4 times daily depending on your brand.||
0719|032|H|Follow your doctor's instructions carefully. Do not cover,||
0719|033|H|bandage, or wrap the area unless directed to do so by your||
0719|034|H|doctor.||
0719|035|H|   After applying the medication, wash your hands unless you are||
0719|036|H|using this medication to treat the hands. If applying this||
0719|037|H|medication near the eyes, avoid getting it in the eyes as this||
0719|038|H|may worsen or cause glaucoma. Also avoid getting this medication||
0719|039|H|in the nose or mouth. If you get the medication in these areas,||
0719|040|H|rinse with plenty of water.||
0719|041|H|   Use this medication only for the condition prescribed. Do not||
0719|042|H|use it for longer than 2 weeks in a row or use more than 60 grams||
0719|043|H|per week unless directed to do so by your doctor.||
0719|044|H|   Tell your doctor if your condition lasts or gets worse after 2||
0719|045|H|weeks of treatment.||
0719|046|B|||
0719|047|S|SIDE EFFECTS:  Burning, stinging, itching, dryness, or redness||
0719|048|S|may occur when this medication is first applied to the skin. This||
0719|049|S|should disappear in a few days as your body adjusts to the||
0719|050|S|medication. If any of these effects last or get worse, tell your||
0719|051|S|doctor or pharmacist promptly.||
0719|052|S|   Remember that this medication has been prescribed because your||
0719|053|S|doctor has judged that the benefit to you is greater than the||
0719|054|S|risk of side effects. Many people using this medication do not||
0719|055|S|have serious side effects.||
0719|056|S|   Tell your doctor right away if you have any serious side||
0719|057|S|effects, including: stretch marks, skin thinning/discoloration,||
0719|058|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0719|059|S|(folliculitis).||
0719|060|S|   Skin infections can become worse when this medication is used.||
0719|061|S|Tell your doctor if redness, swelling, or irritation do not get||
0719|062|S|better.||
0719|063|S|   Rarely, it is possible this medication will be absorbed from||
0719|064|S|the skin into the bloodstream. This can lead to side effects of||
0719|065|S|too much corticosteroid. These side effects are more likely in||
0719|066|S|children, and in people who use this medication for a long time||
0719|067|S|or over large areas of the skin. Tell your doctor right away if||
0719|068|S|any of the following side effects occur: unusual/extreme||
0719|069|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0719|070|S|thirst/urination, vision problems.||
0719|071|S|   A very serious allergic reaction to this drug is rare.||
0719|072|S|However, get medical help right away if you notice any symptoms||
0719|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0719|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0719|075|S|breathing.||
0719|076|S|   This is not a complete list of possible side effects. If you||
0719|077|S|notice other effects not listed above, contact your doctor or||
0719|078|S|pharmacist.||
0719|079|S|   In the US -||
0719|080|S|   Call your doctor for medical advice about side effects. You||
0719|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0719|082|S|www.fda.gov/medwatch.||
0719|083|S|   In Canada - Call your doctor for medical advice about side||
0719|084|S|effects. You may report side effects to Health Canada at||
0719|085|S|1-866-234-2345.||
0719|086|B|||
0719|087|P|PRECAUTIONS:  Before using fluocinonide, tell your doctor or||
0719|088|P|pharmacist if you are allergic to it; or to other corticosteroids||
0719|089|P|(such as hydrocortisone, prednisone); or if you have any other||
0719|090|P|allergies. This product may contain inactive ingredients, which||
0719|091|P|can cause allergic reactions or other problems. Talk to your||
0719|092|P|pharmacist for more details.||
0719|093|P|   Before using this medication, tell your doctor or pharmacist||
0719|094|P|your medical history, especially of: poor blood circulation,||
0719|095|P|immune system problems.||
0719|096|P|   Do not use if there is an infection or sore present in the||
0719|097|P|area to be treated.||
0719|098|P|   Rarely, using corticosteroid medications for a long time or||
0719|099|P|over large areas of skin can make it more difficult for your body||
0719|100|P|to respond to physical stress. Before having surgery or emergency||
0719|101|P|treatment, or if you get a serious illness/injury, tell your||
0719|102|P|doctor or dentist that you are using this medication or have used||
0719|103|P|this medication within the past few months.||
0719|104|P|   Though it is unlikely, this medication may temporarily slow||
0719|105|P|down a child's growth if used for a long time. See the doctor||
0719|106|P|regularly so your child's height can be checked.||
0719|107|P|   During pregnancy, this medication should be used only when||
0719|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
0719|109|P|   It is unknown if this drug passes into breast milk when||
0719|110|P|applied to the skin. Similar medications pass into breast milk||
0719|111|P|when taken by mouth. Consult your doctor before breastfeeding.||
0719|112|B|||
0719|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0719|114|I|medications work or increase your risk for serious side effects.||
0719|115|I|This document does not contain all possible drug interactions.||
0719|116|I|Keep a list of all the products you use (including||
0719|117|I|prescription/nonprescription drugs and herbal products) and share||
0719|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
0719|119|I|the dosage of any medicines without your doctor's approval.||
0719|120|B|||
0719|121|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0719|122|O|has overdosed and has serious symptoms such as passing out or||
0719|123|O|trouble breathing, call 911. Otherwise, call a poison control||
0719|124|O|center right away. US residents can call 1-800-222-1222. Canada||
0719|125|O|residents can call 1-844-764-7669.||
0719|126|B|||
0719|127|N|NOTES:  Do not share this medication with others.||
0719|128|N|   This medication has been prescribed for your current condition||
0719|129|N|only. Do not use it later for another condition unless your||
0719|130|N|doctor tells you to.||
0719|131|N|   Lab tests (such as adrenal gland function) should be done||
0719|132|N|while you are using this medication, especially if you use this||
0719|133|N|medication for an extended period of time or apply it over large||
0719|134|N|areas of the body. Consult your doctor for more details. Keep all||
0719|135|N|medical and lab appointments.||
0719|136|B|||
0719|137|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0719|138|D|If it is near the time of the next dose, skip the missed dose.||
0719|139|D|Use your next dose at the regular time. Do not double the dose to||
0719|140|D|catch up.||
0719|141|B|||
0719|142|R|STORAGE:  Different brands of this medication have different||
0719|143|R|storage needs. Check the product package for instructions on how||
0719|144|R|to store your brand, or ask your pharmacist. Keep all medications||
0719|145|R|away from children and pets.||
0719|146|R|   Do not flush medications down the toilet or pour them into a||
0719|147|R|drain unless instructed to do so. Properly discard this product||
0719|148|R|when it is expired or no longer needed. Consult your pharmacist||
0719|149|R|or local waste disposal company.||
0719|150|B|||
0719|151|A|Information last revised January 2025.||
0719|152|A|Copyright(c) 2025 First Databank, Inc.||
0719|153|B|||
0720|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0720|002|Z|does NOT have all possible information about this product. This||
0720|003|Z|information does not assure that this product is safe, effective,||
0720|004|Z|or appropriate for you. This information is not individual||
0720|005|Z|medical advice and does not substitute for the advice of your||
0720|006|Z|health care professional. Always ask your health care||
0720|007|Z|professional for complete information about this product and your||
0720|008|Z|specific health needs.||
0720|009|B|||
0720|010|T|HYDROCORTISONE VALERATE - TOPICAL||
0720|011|F|(HYE-droe-KOR-ti-sone VAL-er-ate)||
0720|012|B|||
0720|013|C|COMMON BRAND NAME(S): Westcort||
0720|014|B|||
0720|015|U|USES:  This medication is used to treat a variety of skin||
0720|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0720|017|U|Hydrocortisone valerate reduces the swelling, itching, and||
0720|018|U|redness that can occur in these types of conditions. This||
0720|019|U|medication is a medium-strength corticosteroid.||
0720|020|B|||
0720|021|H|HOW TO USE:  Use this medication on the skin only. However, do||
0720|022|H|not use it on the face, groin, or underarms unless directed to do||
0720|023|H|so by your doctor.||
0720|024|H|   Wash and dry your hands before using. Clean and dry the||
0720|025|H|affected area. Apply a thin film of medication to the affected||
0720|026|H|area and gently rub in as directed by your doctor, usually 2 to 3||
0720|027|H|times daily. Do not bandage, cover, or wrap the area unless||
0720|028|H|directed to do so by your doctor.||
0720|029|H|   After applying the medication, wash your hands unless you are||
0720|030|H|using this medication to treat the hands. When applying this||
0720|031|H|medication near the eyes, avoid getting it in the eyes because||
0720|032|H|this may worsen or cause glaucoma. Also, avoid getting this||
0720|033|H|medication in the nose or mouth. If you get the medication in||
0720|034|H|these areas, rinse with plenty of water.||
0720|035|H|   Use this medication only for the condition for which it was||
0720|036|H|prescribed. Do not use it for longer than prescribed.||
0720|037|H|   Tell your doctor if your condition lasts or gets worse after 2||
0720|038|H|weeks.||
0720|039|B|||
0720|040|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
0720|041|S|or redness at the application site may occur when this medication||
0720|042|S|is first applied to the skin. These effects should disappear in a||
0720|043|S|few days as your body adjusts to the medication. If any of these||
0720|044|S|effects last or get worse, notify your doctor or pharmacist||
0720|045|S|promptly.||
0720|046|S|   Remember that this medication has been prescribed because your||
0720|047|S|doctor has judged that the benefit to you is greater than the||
0720|048|S|risk of side effects. Many people using this medication do not||
0720|049|S|have serious side effects.||
0720|050|S|   Tell your doctor right away if you have any serious side||
0720|051|S|effects, including: stretch marks, skin thinning/discoloration,||
0720|052|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0720|053|S|(folliculitis).||
0720|054|S|   Skin infections can become worse when this medication is used.||
0720|055|S|Notify your doctor promptly if redness, swelling, or irritation||
0720|056|S|does not improve.||
0720|057|S|   Rarely, it is possible this medication will be absorbed from||
0720|058|S|the skin into the bloodstream. This can lead to side effects of||
0720|059|S|too much corticosteroid. These side effects are more likely in||
0720|060|S|children, and in people who use this medication for a long time||
0720|061|S|or over large areas of the skin. Tell your doctor right away if||
0720|062|S|any of the following side effects occur: unusual/extreme||
0720|063|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0720|064|S|thirst/urination, vision problems.||
0720|065|S|   A very serious allergic reaction to this drug is rare.||
0720|066|S|However, get medical help right away if you notice any symptoms||
0720|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0720|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0720|069|S|breathing.||
0720|070|S|   This is not a complete list of possible side effects. If you||
0720|071|S|notice other effects not listed above, contact your doctor or||
0720|072|S|pharmacist.||
0720|073|S|   In the US -||
0720|074|S|   Call your doctor for medical advice about side effects. You||
0720|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0720|076|S|www.fda.gov/medwatch.||
0720|077|S|   In Canada - Call your doctor for medical advice about side||
0720|078|S|effects. You may report side effects to Health Canada at||
0720|079|S|1-866-234-2345.||
0720|080|B|||
0720|081|P|PRECAUTIONS:  Before using hydrocortisone valerate, tell your||
0720|082|P|doctor or pharmacist if you are allergic to it; or to other||
0720|083|P|corticosteroids (such as prednisone, triamcinolone); or if you||
0720|084|P|have any other allergies. This product may contain inactive||
0720|085|P|ingredients, which can cause allergic reactions or other||
0720|086|P|problems. Talk to your pharmacist for more details.||
0720|087|P|   Before using this medication, tell your doctor or pharmacist||
0720|088|P|your medical history, especially of: poor blood circulation,||
0720|089|P|diabetes, immune system problems.||
0720|090|P|   Do not use if there is an infection or sore in the area to be||
0720|091|P|treated.||
0720|092|P|   Rarely, using corticosteroid medications for a long time or||
0720|093|P|over large areas of skin can make it more difficult for your body||
0720|094|P|to respond to physical stress. Before having surgery or emergency||
0720|095|P|treatment, or if you get a serious illness/injury, tell your||
0720|096|P|doctor or dentist that you are using this medication or have used||
0720|097|P|this medication within the past few months.||
0720|098|P|   Though it is unlikely, this medication may temporarily slow||
0720|099|P|down a child's growth if used for a long time. See the doctor||
0720|100|P|regularly so your child's height can be checked.||
0720|101|P|   During pregnancy, this medication should be used only when||
0720|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0720|103|P|   It is unknown if this drug passes into breast milk when||
0720|104|P|applied to the skin. Similar medications pass into breast milk||
0720|105|P|when taken by mouth. Consult your doctor before breastfeeding.||
0720|106|B|||
0720|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0720|108|I|medications work or increase your risk for serious side effects.||
0720|109|I|This document does not contain all possible drug interactions.||
0720|110|I|Keep a list of all the products you use (including||
0720|111|I|prescription/nonprescription drugs and herbal products) and share||
0720|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
0720|113|I|the dosage of any medicines without your doctor's approval.||
0720|114|B|||
0720|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0720|116|O|has overdosed and has serious symptoms such as passing out or||
0720|117|O|trouble breathing, call 911. Otherwise, call a poison control||
0720|118|O|center right away. US residents can call 1-800-222-1222. Canada||
0720|119|O|residents can call 1-844-764-7669.||
0720|120|B|||
0720|121|N|NOTES:  Do not share this medication with others.||
0720|122|N|   This medication has been prescribed for your current condition||
0720|123|N|only. Do not use it later for other skin problems unless told to||
0720|124|N|do so by your doctor. A different medication may be necessary in||
0720|125|N|those cases.||
0720|126|N|   Lab and/or medical tests (such as adrenal gland function) may||
0720|127|N|be done while you are using this medication, especially if you||
0720|128|N|use this drug for an extended period of time or apply it over||
0720|129|N|large areas of the body. Keep all medical and lab appointments.||
0720|130|N|Consult your doctor for more details.||
0720|131|B|||
0720|132|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0720|133|D|If it is near the time of the next dose, skip the missed dose.||
0720|134|D|Use your next dose at the regular time. Do not double the dose to||
0720|135|D|catch up.||
0720|136|B|||
0720|137|R|STORAGE:  Store at room temperature. Keep all medications away||
0720|138|R|from children and pets.||
0720|139|R|   Do not flush medications down the toilet or pour them into a||
0720|140|R|drain unless instructed to do so. Properly discard this product||
0720|141|R|when it is expired or no longer needed. Consult your pharmacist||
0720|142|R|or local waste disposal company.||
0720|143|B|||
0720|144|A|Information last revised October 2024.||
0720|145|A|Copyright(c) 2025 First Databank, Inc.||
0720|146|B|||
0721|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0721|002|Z|does NOT have all possible information about this product. This||
0721|003|Z|information does not assure that this product is safe, effective,||
0721|004|Z|or appropriate for you. This information is not individual||
0721|005|Z|medical advice and does not substitute for the advice of your||
0721|006|Z|health care professional. Always ask your health care||
0721|007|Z|professional for complete information about this product and your||
0721|008|Z|specific health needs.||
0721|009|B|||
0721|010|T|FLUOCINOLONE ACETONIDE - TOPICAL||
0721|011|F|(FLOO-oh-SIN-oh-lone uh-SEET-oh-nide)||
0721|012|B|||
0721|013|C|COMMON BRAND NAME(S): Synalar||
0721|014|B|||
0721|015|U|USES:  This medication is used to treat a variety of skin||
0721|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0721|017|U|Fluocinolone reduces the swelling, itching, and redness that can||
0721|018|U|occur in these types of conditions. This medication is a||
0721|019|U|medium-strength corticosteroid.||
0721|020|B|||
0721|021|H|HOW TO USE:  Use this medication on the skin only. However, do||
0721|022|H|not use it on the face, groin, or underarms unless directed to do||
0721|023|H|so by your doctor.||
0721|024|H|   Wash and dry your hands before using. Clean and dry the||
0721|025|H|affected area. Apply a thin film of medication to the affected||
0721|026|H|area and gently rub in as directed by your doctor, usually 3 to 4||
0721|027|H|times daily. Do not bandage, cover, or wrap the area unless||
0721|028|H|directed to do so by your doctor.||
0721|029|H|   After applying the medication, wash your hands unless you are||
0721|030|H|using this medication to treat the hands. When applying this||
0721|031|H|medication near the eyes, avoid getting it in the eyes because||
0721|032|H|this may worsen or cause glaucoma. Also, avoid getting this||
0721|033|H|medication in the nose or mouth. If you get the medication in||
0721|034|H|these areas, rinse with plenty of water.||
0721|035|H|   Use this medication only for the condition for which it was||
0721|036|H|prescribed. Do not use it for longer than prescribed.||
0721|037|H|   Tell your doctor if your condition lasts or gets worse after 2||
0721|038|H|weeks.||
0721|039|B|||
0721|040|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
0721|041|S|or redness at the application site may occur when this medication||
0721|042|S|is first applied to the skin. These effects should disappear in a||
0721|043|S|few days as your body adjusts to the medication. If any of these||
0721|044|S|effects last or get worse, notify your doctor or pharmacist||
0721|045|S|promptly.||
0721|046|S|   Remember that this medication has been prescribed because your||
0721|047|S|doctor has judged that the benefit to you is greater than the||
0721|048|S|risk of side effects. Many people using this medication do not||
0721|049|S|have serious side effects.||
0721|050|S|   Tell your doctor right away if you have any serious side||
0721|051|S|effects, including: stretch marks, skin thinning/discoloration,||
0721|052|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0721|053|S|(folliculitis).||
0721|054|S|   Skin infections can become worse when this medication is used.||
0721|055|S|Notify your doctor promptly if redness, swelling, or irritation||
0721|056|S|does not improve.||
0721|057|S|   Rarely, it is possible this medication will be absorbed from||
0721|058|S|the skin into the bloodstream. This can lead to side effects of||
0721|059|S|too much corticosteroid. These side effects are more likely in||
0721|060|S|children, and in people who use this medication for a long time||
0721|061|S|or over large areas of the skin. Tell your doctor right away if||
0721|062|S|any of the following side effects occur: unusual/extreme||
0721|063|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0721|064|S|thirst/urination, vision problems.||
0721|065|S|   A very serious allergic reaction to this drug is rare.||
0721|066|S|However, get medical help right away if you notice any symptoms||
0721|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0721|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0721|069|S|breathing.||
0721|070|S|   This is not a complete list of possible side effects. If you||
0721|071|S|notice other effects not listed above, contact your doctor or||
0721|072|S|pharmacist.||
0721|073|S|   In the US -||
0721|074|S|   Call your doctor for medical advice about side effects. You||
0721|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0721|076|S|www.fda.gov/medwatch.||
0721|077|S|   In Canada - Call your doctor for medical advice about side||
0721|078|S|effects. You may report side effects to Health Canada at||
0721|079|S|1-866-234-2345.||
0721|080|B|||
0721|081|P|PRECAUTIONS:  Before using fluocinolone, tell your doctor or||
0721|082|P|pharmacist if you are allergic to it; or to other corticosteroids||
0721|083|P|(such as hydrocortisone, prednisone); or if you have any other||
0721|084|P|allergies. This product may contain inactive ingredients, which||
0721|085|P|can cause allergic reactions or other problems. Talk to your||
0721|086|P|pharmacist for more details.||
0721|087|P|   Before using this medication, tell your doctor or pharmacist||
0721|088|P|your medical history, especially of: poor blood circulation,||
0721|089|P|diabetes, immune system problems.||
0721|090|P|   Do not use if there is an infection or sore in the area to be||
0721|091|P|treated.||
0721|092|P|   Rarely, using corticosteroid medications for a long time or||
0721|093|P|over large areas of skin can make it more difficult for your body||
0721|094|P|to respond to physical stress. Before having surgery or emergency||
0721|095|P|treatment, or if you get a serious illness/injury, tell your||
0721|096|P|doctor or dentist that you are using this medication or have used||
0721|097|P|this medication within the past few months.||
0721|098|P|   Though it is unlikely, this medication may temporarily slow||
0721|099|P|down a child's growth if used for a long time. See the doctor||
0721|100|P|regularly so your child's height can be checked.||
0721|101|P|   During pregnancy, this medication should be used only when||
0721|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
0721|103|P|   It is unknown if this drug passes into breast milk when||
0721|104|P|applied to the skin. Similar medications pass into breast milk||
0721|105|P|when taken by mouth. Consult your doctor before breastfeeding.||
0721|106|B|||
0721|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0721|108|I|medications work or increase your risk for serious side effects.||
0721|109|I|This document does not contain all possible drug interactions.||
0721|110|I|Keep a list of all the products you use (including||
0721|111|I|prescription/nonprescription drugs and herbal products) and share||
0721|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
0721|113|I|the dosage of any medicines without your doctor's approval.||
0721|114|B|||
0721|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0721|116|O|has overdosed and has serious symptoms such as passing out or||
0721|117|O|trouble breathing, call 911. Otherwise, call a poison control||
0721|118|O|center right away. US residents can call 1-800-222-1222. Canada||
0721|119|O|residents can call 1-844-764-7669.||
0721|120|B|||
0721|121|N|NOTES:  Do not share this medication with others.||
0721|122|N|   This medication has been prescribed for your current condition||
0721|123|N|only. Do not use it later for other skin problems unless told to||
0721|124|N|do so by your doctor. A different medication may be necessary in||
0721|125|N|those cases.||
0721|126|N|   Lab and/or medical tests (such as adrenal gland function) may||
0721|127|N|be done while you are using this medication, especially if you||
0721|128|N|use this drug for an extended period of time or apply it over||
0721|129|N|large areas of the body. Keep all medical and lab appointments.||
0721|130|N|Consult your doctor for more details.||
0721|131|B|||
0721|132|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0721|133|D|If it is near the time of the next dose, skip the missed dose.||
0721|134|D|Use your next dose at the regular time. Do not double the dose to||
0721|135|D|catch up.||
0721|136|B|||
0721|137|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
0721|138|R|medications away from children and pets.||
0721|139|R|   Do not flush medications down the toilet or pour them into a||
0721|140|R|drain unless instructed to do so. Properly discard this product||
0721|141|R|when it is expired or no longer needed. Consult your pharmacist||
0721|142|R|or local waste disposal company.||
0721|143|B|||
0721|144|A|Information last revised October 2024.||
0721|145|A|Copyright(c) 2025 First Databank, Inc.||
0721|146|B|||
0722|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0722|002|Z|does NOT have all possible information about this product. This||
0722|003|Z|information does not assure that this product is safe, effective,||
0722|004|Z|or appropriate for you. This information is not individual||
0722|005|Z|medical advice and does not substitute for the advice of your||
0722|006|Z|health care professional. Always ask your health care||
0722|007|Z|professional for complete information about this product and your||
0722|008|Z|specific health needs.||
0722|009|B|||
0722|010|T|BETAMETHASONE VALERATE - TOPICAL||
0722|011|F|(BAY-ta-METH-a-sone VAL-er-ate)||
0722|012|B|||
0722|013|C|COMMON BRAND NAME(S): Beta-Val||
0722|014|B|||
0722|015|U|USES:  This medication is used to treat a variety of skin||
0722|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0722|017|U|Betamethasone reduces the swelling, itching, and redness that can||
0722|018|U|occur in these types of conditions. This medication is a||
0722|019|U|medium-strength corticosteroid.||
0722|020|B|||
0722|021|H|HOW TO USE:  Use this medication on the skin only. However, do||
0722|022|H|not use it on the face, groin, or underarms unless directed to do||
0722|023|H|so by your doctor.||
0722|024|H|   Wash and dry your hands before using. Clean and dry the||
0722|025|H|affected area. Apply a thin film of medication to the affected||
0722|026|H|area and gently rub in as directed by your doctor, usually 1 to 3||
0722|027|H|times daily. Do not bandage, cover, or wrap the area unless||
0722|028|H|directed to do so by your doctor.||
0722|029|H|   After applying the medication, wash your hands unless you are||
0722|030|H|using this medication to treat the hands. When applying this||
0722|031|H|medication near the eyes, avoid getting it in the eyes because||
0722|032|H|this may worsen or cause glaucoma. Also, avoid getting this||
0722|033|H|medication in the nose or mouth. If you get the medication in||
0722|034|H|these areas, rinse with plenty of water.||
0722|035|H|   Use this medication only for the condition for which it was||
0722|036|H|prescribed. Do not use it for longer than prescribed.||
0722|037|H|   Tell your doctor if your condition lasts or gets worse after 2||
0722|038|H|weeks.||
0722|039|B|||
0722|040|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
0722|041|S|or redness of the skin may occur when this medication is first||
0722|042|S|applied to the skin. These effects should disappear in a few days||
0722|043|S|as your body adjusts to the medication. If any of these effects||
0722|044|S|last or get worse, notify your doctor or pharmacist promptly.||
0722|045|S|   Remember that this medication has been prescribed because your||
0722|046|S|doctor has judged that the benefit to you is greater than the||
0722|047|S|risk of side effects. Many people using this medication do not||
0722|048|S|have serious side effects.||
0722|049|S|   Tell your doctor right away if you have any serious side||
0722|050|S|effects, including: stretch marks, skin thinning/discoloration,||
0722|051|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0722|052|S|(folliculitis).||
0722|053|S|   Skin infections can become worse when this medication is used.||
0722|054|S|Tell your doctor promptly if redness, swelling, or irritation||
0722|055|S|does not improve.||
0722|056|S|   Rarely, it is possible this medication will be absorbed from||
0722|057|S|the skin into the bloodstream. This can lead to side effects of||
0722|058|S|too much corticosteroid. These side effects are more likely in||
0722|059|S|children, and in people who use this medication for a long time||
0722|060|S|or over large areas of the skin. Tell your doctor right away if||
0722|061|S|any of the following side effects occur: unusual/extreme||
0722|062|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0722|063|S|thirst/urination, vision problems.||
0722|064|S|   A very serious allergic reaction to this drug is rare.||
0722|065|S|However, get medical help right away if you notice any symptoms||
0722|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0722|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0722|068|S|breathing.||
0722|069|S|   This is not a complete list of possible side effects. If you||
0722|070|S|notice other effects not listed above, contact your doctor or||
0722|071|S|pharmacist.||
0722|072|S|   In the US -||
0722|073|S|   Call your doctor for medical advice about side effects. You||
0722|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0722|075|S|www.fda.gov/medwatch.||
0722|076|S|   In Canada - Call your doctor for medical advice about side||
0722|077|S|effects. You may report side effects to Health Canada at||
0722|078|S|1-866-234-2345.||
0722|079|B|||
0722|080|P|PRECAUTIONS:  Before using betamethasone, tell your doctor or||
0722|081|P|pharmacist if you are allergic to it; or to other corticosteroids||
0722|082|P|(such as hydrocortisone, prednisone); or if you have any other||
0722|083|P|allergies. This product may contain inactive ingredients, which||
0722|084|P|can cause allergic reactions or other problems. Talk to your||
0722|085|P|pharmacist for more details.||
0722|086|P|   Before using this medication, tell your doctor or pharmacist||
0722|087|P|your medical history, especially of: poor blood circulation,||
0722|088|P|diabetes, immune system problems.||
0722|089|P|   Do not use if there is an infection or sore in the area to be||
0722|090|P|treated.||
0722|091|P|   Rarely, using corticosteroid medications for a long time or||
0722|092|P|over large areas of skin can make it more difficult for your body||
0722|093|P|to respond to physical stress. Before having surgery or emergency||
0722|094|P|treatment, or if you get a serious illness/injury, tell your||
0722|095|P|doctor or dentist that you are using this medication or have used||
0722|096|P|this medication within the past few months.||
0722|097|P|   Though it is unlikely, this medication may temporarily slow||
0722|098|P|down a child's growth if used for a long time. See the doctor||
0722|099|P|regularly so your child's height can be checked.||
0722|100|P|   During pregnancy, this medication should be used only when||
0722|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
0722|102|P|   It is unknown if this drug passes into breast milk. Similar||
0722|103|P|medications pass into breast milk. Consult your doctor before||
0722|104|P|breastfeeding.||
0722|105|B|||
0722|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0722|107|I|medications work or increase your risk for serious side effects.||
0722|108|I|This document does not contain all possible drug interactions.||
0722|109|I|Keep a list of all the products you use (such as||
0722|110|I|prescription/nonprescription drugs and herbal products) and share||
0722|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0722|112|I|the dosage of any medicines without your doctor's approval.||
0722|113|B|||
0722|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0722|115|O|has overdosed and has serious symptoms such as passing out or||
0722|116|O|trouble breathing, call 911. Otherwise, call a poison control||
0722|117|O|center right away. US residents can call 1-800-222-1222. Canada||
0722|118|O|residents can call 1-844-764-7669.||
0722|119|B|||
0722|120|N|NOTES:  Do not share this medication with others.||
0722|121|N|   This medication has been prescribed for your current condition||
0722|122|N|only. Do not use it later for other skin problems unless told to||
0722|123|N|do so by your doctor. A different medication may be necessary in||
0722|124|N|those cases.||
0722|125|N|   Lab and/or medical tests (such as adrenal gland function) may||
0722|126|N|be done while you are using this medication, especially if you||
0722|127|N|use this drug for an extended period of time or apply it over||
0722|128|N|large areas of the body. Keep all medical and lab appointments.||
0722|129|N|Consult your doctor for more details.||
0722|130|B|||
0722|131|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0722|132|D|If it is near the time of the next dose, skip the missed dose.||
0722|133|D|Use your next dose at the regular time. Do not double the dose to||
0722|134|D|catch up.||
0722|135|B|||
0722|136|R|STORAGE:  Store at room temperature. Keep all medications away||
0722|137|R|from children and pets.||
0722|138|R|   Do not flush medications down the toilet or pour them into a||
0722|139|R|drain unless instructed to do so. Properly discard this product||
0722|140|R|when it is expired or no longer needed. Consult your pharmacist||
0722|141|R|or local waste disposal company.||
0722|142|B|||
0722|143|A|Information last revised October 2024.||
0722|144|A|Copyright(c) 2025 First Databank, Inc.||
0722|145|B|||
0723|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0723|002|Z|does NOT have all possible information about this product. This||
0723|003|Z|information does not assure that this product is safe, effective,||
0723|004|Z|or appropriate for you. This information is not individual||
0723|005|Z|medical advice and does not substitute for the advice of your||
0723|006|Z|health care professional. Always ask your health care||
0723|007|Z|professional for complete information about this product and your||
0723|008|Z|specific health needs.||
0723|009|B|||
0723|010|T|CLOBETASOL - TOPICAL||
0723|011|F|(kloe-BAY-ta-sol)||
0723|012|B|||
0723|013|C|COMMON BRAND NAME(S): Cormax, Temovate||
0723|014|B|||
0723|015|U|USES:  This medication is used to treat a variety of skin||
0723|016|U|conditions (such as eczema, psoriasis, dermatitis, allergies,||
0723|017|U|rash). Clobetasol reduces the swelling, itching, and redness that||
0723|018|U|can occur in these types of conditions. This medication is a very||
0723|019|U|strong (super-high-potency) corticosteroid.||
0723|020|B|||
0723|021|H|HOW TO USE:  Use this medication on the skin only. Do not use it||
0723|022|H|on the face, groin, or underarms unless directed to do so by your||
0723|023|H|doctor.||
0723|024|H|   Wash and dry your hands before using. Clean and dry the||
0723|025|H|affected area. Apply a thin film of medication to the affected||
0723|026|H|area and gently rub in as directed by your doctor, usually 2||
0723|027|H|times daily. Do not bandage, cover, or wrap the area unless||
0723|028|H|directed to do so by your doctor.||
0723|029|H|   After applying the medication, wash your hands unless you are||
0723|030|H|using this medication to treat the hands. When applying this||
0723|031|H|medication near the eyes, avoid getting it in the eyes because||
0723|032|H|this may worsen or cause glaucoma. Also, avoid getting this||
0723|033|H|medication in the nose or mouth. If you get the medication in||
0723|034|H|these areas, rinse with plenty of water.||
0723|035|H|   Use this medication only for the condition prescribed. Do not||
0723|036|H|use it for longer than 2 weeks in a row or use more than 50 grams||
0723|037|H|per week unless directed to do so by your doctor.||
0723|038|H|   Tell your doctor if your condition lasts or gets worse after 2||
0723|039|H|weeks.||
0723|040|B|||
0723|041|S|SIDE EFFECTS:  Burning, stinging, itching, dryness, or redness at||
0723|042|S|the application site may occur when first applied to the skin.||
0723|043|S|This should disappear in a few days as your body adjusts to the||
0723|044|S|medication. If any of these effects last or get worse, notify||
0723|045|S|your doctor or pharmacist promptly.||
0723|046|S|   Remember that this medication has been prescribed because your||
0723|047|S|doctor has judged that the benefit to you is greater than the||
0723|048|S|risk of side effects. Many people using this medication do not||
0723|049|S|have serious side effects.||
0723|050|S|   Tell your doctor right away if you have any serious side||
0723|051|S|effects, including: stretch marks, skin thinning/discoloration,||
0723|052|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0723|053|S|(folliculitis).||
0723|054|S|   Skin infections can become worse when this medication is used.||
0723|055|S|Notify your doctor promptly if redness, swelling, or irritation||
0723|056|S|does not improve.||
0723|057|S|   Rarely, it is possible this medication will be absorbed from||
0723|058|S|the skin into the bloodstream. This can lead to side effects of||
0723|059|S|too much corticosteroid. These side effects are more likely in||
0723|060|S|children, and in people who use this medication for a long time||
0723|061|S|or over large areas of the skin. Tell your doctor right away if||
0723|062|S|any of the following side effects occur: unusual/extreme||
0723|063|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0723|064|S|thirst/urination, vision problems.||
0723|065|S|   A very serious allergic reaction to this drug is rare.||
0723|066|S|However, get medical help right away if you notice any symptoms||
0723|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0723|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0723|069|S|breathing.||
0723|070|S|   This is not a complete list of possible side effects. If you||
0723|071|S|notice other effects not listed above, contact your doctor or||
0723|072|S|pharmacist.||
0723|073|S|   In the US -||
0723|074|S|   Call your doctor for medical advice about side effects. You||
0723|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0723|076|S|www.fda.gov/medwatch.||
0723|077|S|   In Canada - Call your doctor for medical advice about side||
0723|078|S|effects. You may report side effects to Health Canada at||
0723|079|S|1-866-234-2345.||
0723|080|B|||
0723|081|P|PRECAUTIONS:  Before using clobetasol, tell your doctor or||
0723|082|P|pharmacist if you are allergic to it; or to other corticosteroids||
0723|083|P|(such as hydrocortisone, prednisone); or if you have any other||
0723|084|P|allergies. This product may contain inactive ingredients, which||
0723|085|P|can cause allergic reactions or other problems. Talk to your||
0723|086|P|pharmacist for more details.||
0723|087|P|   Before using this medication, tell your doctor or pharmacist||
0723|088|P|your medical history, especially of: poor blood circulation,||
0723|089|P|immune system problems, certain skin conditions (rosacea,||
0723|090|P|perioral dermatitis).||
0723|091|P|   Do not use if there is an infection or sore present in the||
0723|092|P|area to be treated.||
0723|093|P|   Rarely, using corticosteroid medications for a long time or||
0723|094|P|over large areas of skin can make it more difficult for your body||
0723|095|P|to respond to physical stress. Before having surgery or emergency||
0723|096|P|treatment, or if you get a serious illness/injury, tell your||
0723|097|P|doctor or dentist that you are using this medication or have used||
0723|098|P|this medication within the past few months.||
0723|099|P|   Though it is unlikely, this medication may temporarily slow||
0723|100|P|down a child's growth if used for a long time. See the doctor||
0723|101|P|regularly so your child's height can be checked.||
0723|102|P|   During pregnancy, this medication should be used only when||
0723|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
0723|104|P|   It is unknown if this drug passes into breast milk when||
0723|105|P|applied to the skin. Similar medications pass into breast milk||
0723|106|P|when taken by mouth. Consult your doctor before breastfeeding.||
0723|107|B|||
0723|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0723|109|I|medications work or increase your risk for serious side effects.||
0723|110|I|This document does not contain all possible drug interactions.||
0723|111|I|Keep a list of all the products you use (including||
0723|112|I|prescription/nonprescription drugs and herbal products) and share||
0723|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
0723|114|I|the dosage of any medicines without your doctor's approval.||
0723|115|B|||
0723|116|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0723|117|O|has overdosed and has serious symptoms such as passing out or||
0723|118|O|trouble breathing, call 911. Otherwise, call a poison control||
0723|119|O|center right away. US residents can call 1-800-222-1222. Canada||
0723|120|O|residents can call 1-844-764-7669.||
0723|121|B|||
0723|122|N|NOTES:  Do not share this medication with others.||
0723|123|N|   This medication has been prescribed for your current condition||
0723|124|N|only. Do not use it later for other skin problems unless told to||
0723|125|N|do so by your doctor. A different medication may be necessary in||
0723|126|N|those cases.||
0723|127|N|   Lab and/or medical tests (such as adrenal gland function) may||
0723|128|N|be done while you are using this medication, especially if you||
0723|129|N|use this drug for an extended period of time or apply it over||
0723|130|N|large areas of the body. Keep all medical and lab appointments.||
0723|131|N|Consult your doctor for more details.||
0723|132|B|||
0723|133|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0723|134|D|If it is near the time of the next dose, skip the missed dose.||
0723|135|D|Use your next dose at the regular time. Do not double the dose to||
0723|136|D|catch up.||
0723|137|B|||
0723|138|R|STORAGE:  Store at room temperature. Do not refrigerate or||
0723|139|R|freeze. Keep all medications away from children and pets.||
0723|140|R|   Do not flush medications down the toilet or pour them into a||
0723|141|R|drain unless instructed to do so. Properly discard this product||
0723|142|R|when it is expired or no longer needed. Consult your pharmacist||
0723|143|R|or local waste disposal company.||
0723|144|B|||
0723|145|A|Information last revised October 2024.||
0723|146|A|Copyright(c) 2025 First Databank, Inc.||
0723|147|B|||
0724|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0724|002|Z|does NOT have all possible information about this product. This||
0724|003|Z|information does not assure that this product is safe, effective,||
0724|004|Z|or appropriate for you. This information is not individual||
0724|005|Z|medical advice and does not substitute for the advice of your||
0724|006|Z|health care professional. Always ask your health care||
0724|007|Z|professional for complete information about this product and your||
0724|008|Z|specific health needs.||
0724|009|B|||
0724|010|T|BETAMETHASONE DIPROPIONATE - TOPICAL||
0724|011|F|(BAY-ta-METH-a-sone dye-PROP-pee-on-ate)||
0724|012|B|||
0724|013|C|COMMON BRAND NAME(S): Diprolene, Diprosone||
0724|014|B|||
0724|015|U|USES:  This medication is used to treat a variety of skin||
0724|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0724|017|U|Betamethasone reduces the swelling, itching, and redness that can||
0724|018|U|occur in these types of conditions. This medication is a strong||
0724|019|U|corticosteroid.||
0724|020|B|||
0724|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0724|022|H|from your pharmacist before you start using this medication and||
0724|023|H|each time you get a refill. If you have any questions, ask your||
0724|024|H|doctor or pharmacist.||
0724|025|H|   Use this medication on the skin only. However, do not use it||
0724|026|H|on the face, groin, or underarms or for diaper rash unless||
0724|027|H|directed to do so by your doctor.||
0724|028|H|   Wash and dry your hands. Before applying the medication, clean||
0724|029|H|and dry the affected area. Apply a thin film of the medication to||
0724|030|H|the affected area and gently rub in as directed by your doctor,||
0724|031|H|usually 1 to 2 times daily.||
0724|032|H|   Do not cover, bandage, or wrap the area unless directed to do||
0724|033|H|so by your doctor.||
0724|034|H|   If you are using the lotion form of this medication, shake the||
0724|035|H|bottle well before each dose.||
0724|036|H|   After applying the medication, wash your hands unless you are||
0724|037|H|using this medication to treat the hands. When applying this||
0724|038|H|medication near the eyes, avoid getting it in the eyes as this||
0724|039|H|may worsen or cause glaucoma. Also, avoid getting this medication||
0724|040|H|in the nose or mouth. If you get the medication in these areas,||
0724|041|H|rinse with plenty of water.||
0724|042|H|   Use this medication only for the condition for which it was||
0724|043|H|prescribed. Do not use it for longer than prescribed.||
0724|044|H|   Tell your doctor if your condition lasts or gets worse after 2||
0724|045|H|weeks.||
0724|046|B|||
0724|047|S|SIDE EFFECTS:  Burning, itching, irritation, or dryness at the||
0724|048|S|application site may occur when this medication is first applied||
0724|049|S|to the skin. This should disappear in a few days as your body||
0724|050|S|adjusts to the medication. If any of these effects last or get||
0724|051|S|worse, notify your doctor or pharmacist promptly.||
0724|052|S|   Remember that this medication has been prescribed because your||
0724|053|S|doctor has judged that the benefit to you is greater than the||
0724|054|S|risk of side effects. Many people using this medication do not||
0724|055|S|have serious side effects.||
0724|056|S|   Tell your doctor right away if you have any serious side||
0724|057|S|effects, including: stretch marks, skin thinning/discoloration,||
0724|058|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0724|059|S|(folliculitis).||
0724|060|S|   Skin infections can become worse when this medication is used.||
0724|061|S|Tell your doctor if redness, swelling, or irritation does not||
0724|062|S|improve.||
0724|063|S|   Rarely, it is possible this medication will be absorbed from||
0724|064|S|the skin into the bloodstream. This can lead to side effects of||
0724|065|S|too much corticosteroid. These side effects are more likely in||
0724|066|S|children, and in people who use this medication for a long time||
0724|067|S|or over large areas of the skin. Tell your doctor right away if||
0724|068|S|any of the following side effects occur: unusual/extreme||
0724|069|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0724|070|S|thirst/urination, vision problems.||
0724|071|S|   A very serious allergic reaction to this drug is rare.||
0724|072|S|However, get medical help right away if you notice any symptoms||
0724|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0724|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0724|075|S|breathing.||
0724|076|S|   This is not a complete list of possible side effects. If you||
0724|077|S|notice other effects not listed above, contact your doctor or||
0724|078|S|pharmacist.||
0724|079|S|   In the US -||
0724|080|S|   Call your doctor for medical advice about side effects. You||
0724|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0724|082|S|www.fda.gov/medwatch.||
0724|083|S|   In Canada - Call your doctor for medical advice about side||
0724|084|S|effects. You may report side effects to Health Canada at||
0724|085|S|1-866-234-2345.||
0724|086|B|||
0724|087|P|PRECAUTIONS:  Before using betamethasone, tell your doctor or||
0724|088|P|pharmacist if you are allergic to it; or to other corticosteroids||
0724|089|P|(such as hydrocortisone, prednisone); or if you have any other||
0724|090|P|allergies. This product may contain inactive ingredients, which||
0724|091|P|can cause allergic reactions or other problems. Talk to your||
0724|092|P|pharmacist for more details.||
0724|093|P|   Before using this medication, tell your doctor or pharmacist||
0724|094|P|your medical history, especially of: poor blood circulation,||
0724|095|P|immune system problems.||
0724|096|P|   Do not use if there is an infection or sore present in the||
0724|097|P|area to be treated.||
0724|098|P|   Rarely, using corticosteroid medications for a long time or||
0724|099|P|over large areas of skin can make it more difficult for your body||
0724|100|P|to respond to physical stress. Before having surgery or emergency||
0724|101|P|treatment, or if you get a serious illness/injury, tell your||
0724|102|P|doctor or dentist that you are using this medication or have used||
0724|103|P|this medication within the past few months.||
0724|104|P|   Though it is unlikely, this medication may temporarily slow||
0724|105|P|down a child's growth if used for a long time. See the doctor||
0724|106|P|regularly so your child's height can be checked.||
0724|107|P|   During pregnancy, this medication should be used only when||
0724|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
0724|109|P|   It is unknown if this drug passes into breast milk. Similar||
0724|110|P|medications pass into breast milk. Consult your doctor before||
0724|111|P|breastfeeding.||
0724|112|B|||
0724|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0724|114|I|medications work or increase your risk for serious side effects.||
0724|115|I|This document does not contain all possible drug interactions.||
0724|116|I|Keep a list of all the products you use (such as||
0724|117|I|prescription/nonprescription drugs and herbal products) and share||
0724|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
0724|119|I|the dosage of any medicines without your doctor's approval.||
0724|120|B|||
0724|121|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0724|122|O|has overdosed and has serious symptoms such as passing out or||
0724|123|O|trouble breathing, call 911. Otherwise, call a poison control||
0724|124|O|center right away. US residents can call 1-800-222-1222. Canada||
0724|125|O|residents can call 1-844-764-7669.||
0724|126|B|||
0724|127|N|NOTES:  Do not share this medication with others.||
0724|128|N|   This medication has been prescribed for your current condition||
0724|129|N|only. Do not use it later for other skin problems unless told to||
0724|130|N|do so by your doctor. A different medication may be necessary in||
0724|131|N|those cases.||
0724|132|N|   Lab and/or medical tests (such as adrenal gland function) may||
0724|133|N|be done while you are using this medication, especially if you||
0724|134|N|use this drug for an extended period of time or apply it over||
0724|135|N|large areas of the body. Keep all medical and lab appointments.||
0724|136|N|Consult your doctor for more details.||
0724|137|B|||
0724|138|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0724|139|D|If it is near the time of the next dose, skip the missed dose.||
0724|140|D|Use your next dose at the regular time. Do not double the dose to||
0724|141|D|catch up.||
0724|142|B|||
0724|143|R|STORAGE:  Store at room temperature. Keep all medications away||
0724|144|R|from children and pets.||
0724|145|R|   Do not flush medications down the toilet or pour them into a||
0724|146|R|drain unless instructed to do so. Properly discard this product||
0724|147|R|when it is expired or no longer needed. Consult your pharmacist||
0724|148|R|or local waste disposal company.||
0724|149|B|||
0724|150|A|Information last revised October 2024.||
0724|151|A|Copyright(c) 2025 First Databank, Inc.||
0724|152|B|||
0725|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0725|002|Z|does NOT have all possible information about this product. This||
0725|003|Z|information does not assure that this product is safe, effective,||
0725|004|Z|or appropriate for you. This information is not individual||
0725|005|Z|medical advice and does not substitute for the advice of your||
0725|006|Z|health care professional. Always ask your health care||
0725|007|Z|professional for complete information about this product and your||
0725|008|Z|specific health needs.||
0725|009|B|||
0725|010|T|RASAGILINE - ORAL||
0725|011|F|(ra-SA-ji-leen)||
0725|012|B|||
0725|013|C|COMMON BRAND NAME(S): Azilect||
0725|014|B|||
0725|015|U|USES:  Rasagiline is used alone or with other medications (such||
0725|016|U|as levodopa/carbidopa) to treat symptoms of Parkinson's disease.||
0725|017|U|It can help improve symptoms such as shakiness, stiffness, and||
0725|018|U|difficulty moving. It can also help reduce the amount of "off"||
0725|019|U|time (periods of slow movement or stiffness).||
0725|020|U|   Rasagiline belongs to a class of drugs known as MAO||
0725|021|U|inhibitors. It works by increasing the levels of certain natural||
0725|022|U|substances in the brain (such as dopamine, norepinephrine,||
0725|023|U|serotonin). Parkinson's disease is thought to be caused by too||
0725|024|U|little dopamine in the brain.||
0725|025|B|||
0725|026|H|HOW TO USE:  Take this medication by mouth with or without food||
0725|027|H|as directed by your doctor, usually once daily.||
0725|028|H|   The dosage is based on your medical condition, response to||
0725|029|H|treatment, and other medications you may be taking. Be sure to||
0725|030|H|tell your doctor and pharmacist about all the products you use||
0725|031|H|(including prescription drugs, nonprescription drugs, and herbal||
0725|032|H|products). Do not increase your dose or take it more often than||
0725|033|H|prescribed. Your condition will not improve any faster, and your||
0725|034|H|risk of side effects will increase.||
0725|035|H|   Do not stop taking this medication without consulting your||
0725|036|H|doctor. Some conditions may become worse when this drug is||
0725|037|H|suddenly stopped. Your dose may need to be gradually decreased.||
0725|038|H|   A very serious high blood pressure reaction may rarely occur||
0725|039|H|if you eat a large amount of tyramine while taking rasagiline and||
0725|040|H|for 2 weeks after you stop it. Avoid foods that are high in||
0725|041|H|tyramine, like aged cheeses (such as Stilton cheese). Consult||
0725|042|H|your doctor or dietician about which foods you should avoid and||
0725|043|H|if you do not feel well after eating or drinking certain foods||
0725|044|H|while taking this medication. See also Side Effects section.||
0725|045|H|   Tell your doctor if this medication stops working well or if||
0725|046|H|your condition gets worse.||
0725|047|B|||
0725|048|S|SIDE EFFECTS:  Dizziness, drowsiness, joint pain, heartburn,||
0725|049|S|nausea, dry mouth, weight loss, or stomach/abdominal pain may||
0725|050|S|occur. If any of these effects last or get worse, tell your||
0725|051|S|doctor or pharmacist promptly.||
0725|052|S|   To reduce the risk of dizziness and lightheadedness, get up||
0725|053|S|slowly when rising from a sitting or lying position, especially||
0725|054|S|when you first start taking rasagiline.||
0725|055|S|   Remember that this medication has been prescribed because your||
0725|056|S|doctor has judged that the benefit to you is greater than the||
0725|057|S|risk of side effects. Many people using this medication do not||
0725|058|S|have serious side effects.||
0725|059|S|   Tell your doctor right away if you have any serious side||
0725|060|S|effects, including: fainting, loss of balance, mental/mood||
0725|061|S|changes (such as confusion, depression, hallucinations),||
0725|062|S|worsening muscle stiffness/twitching/uncontrollable movements,||
0725|063|S|swollen ankles/legs, easy bleeding/bruising, unusual strong urges||
0725|064|S|(such as increased gambling, increased sexual urges).||
0725|065|S|   Some people taking rasagiline have fallen asleep suddenly||
0725|066|S|during their usual daily activities (such as talking on the||
0725|067|S|phone, driving). In some cases, sleep occurred without any||
0725|068|S|feelings of drowsiness beforehand. This sleep effect may occur||
0725|069|S|anytime during treatment with rasagiline even if you have used||
0725|070|S|this medication for a long time. If you experience increased||
0725|071|S|sleepiness or fall asleep during the day, do not drive or take||
0725|072|S|part in other possibly dangerous activities until you have||
0725|073|S|discussed this effect with your doctor. Your risk of this sleep||
0725|074|S|effect is increased by using alcohol or other medications that||
0725|075|S|can make you drowsy. See also Precautions section.||
0725|076|S|   This medication may increase serotonin and rarely cause a very||
0725|077|S|serious condition called serotonin syndrome/toxicity. The risk||
0725|078|S|increases if you are also taking other drugs that increase||
0725|079|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0725|080|S|take. Get medical help right away if you develop some of the||
0725|081|S|following symptoms: fast heartbeat, hallucinations, loss of||
0725|082|S|coordination, severe dizziness, severe nausea/vomiting/diarrhea,||
0725|083|S|twitching muscles, unexplained fever, unusual||
0725|084|S|agitation/restlessness.||
0725|085|S|   This drug may rarely cause an attack of extremely high blood||
0725|086|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
0725|087|S|food interactions can increase this risk (see How to Use and Drug||
0725|088|S|Interactions sections). Get medical help right away if any of||
0725|089|S|these serious side effects occur: severe headache,||
0725|090|S|fast/slow/irregular/pounding heartbeat, chest pain, neck||
0725|091|S|stiffness/soreness, severe nausea/vomiting, sweating/clammy skin||
0725|092|S|(sometimes with fever), widened pupils, vision changes (such as||
0725|093|S|double/blurred vision), sudden sensitivity to light||
0725|094|S|(photophobia).||
0725|095|S|   A very serious allergic reaction to this drug is rare.||
0725|096|S|However, get medical help right away if you notice any symptoms||
0725|097|S|of a serious allergic reaction, including: rash, itching/swelling||
0725|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0725|099|S|breathing.||
0725|100|S|   This is not a complete list of possible side effects. If you||
0725|101|S|notice other effects not listed above, contact your doctor or||
0725|102|S|pharmacist.||
0725|103|S|   In the US -||
0725|104|S|   Call your doctor for medical advice about side effects. You||
0725|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0725|106|S|www.fda.gov/medwatch.||
0725|107|S|   In Canada - Call your doctor for medical advice about side||
0725|108|S|effects. You may report side effects to Health Canada at||
0725|109|S|1-866-234-2345.||
0725|110|B|||
0725|111|P|PRECAUTIONS:  Before taking rasagiline, tell your doctor or||
0725|112|P|pharmacist if you are allergic to it; or if you have any other||
0725|113|P|allergies. This product may contain inactive ingredients, which||
0725|114|P|can cause allergic reactions or other problems. Talk to your||
0725|115|P|pharmacist for more details.||
0725|116|P|   Before using this medication, tell your doctor or pharmacist||
0725|117|P|your medical history, especially of: heart disease (such as||
0725|118|P|coronary artery disease, heart attack, chest pain, heart||
0725|119|P|failure), stroke, high blood pressure, severe/frequent headaches,||
0725|120|P|liver disease, mental/mood disorders (such as schizophrenia,||
0725|121|P|bipolar disorder, depression), diabetes, overactive thyroid, a||
0725|122|P|certain adrenal gland tumor (pheochromocytoma), sleep disorders.||
0725|123|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0725|124|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0725|125|P|machinery, or do anything that needs alertness until you can do||
0725|126|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0725|127|P|are using marijuana (cannabis). See also Side Effects section.||
0725|128|P|   Before having surgery, tell your doctor or dentist about all||
0725|129|P|the products you use (including prescription drugs,||
0725|130|P|nonprescription drugs, and herbal products).||
0725|131|P|   During pregnancy, this medication should be used only when||
0725|132|P|clearly needed. Discuss the risks and benefits with your doctor.||
0725|133|P|   It is unknown if this drug passes into breast milk. Consult||
0725|134|P|your doctor before breastfeeding.||
0725|135|B|||
0725|136|I|DRUG INTERACTIONS:  See also How to Use section.||
0725|137|I|   Drug interactions may change how your medications work or||
0725|138|I|increase your risk for serious side effects. This document does||
0725|139|I|not contain all possible drug interactions. Keep a list of all||
0725|140|I|the products you use (including prescription/nonprescription||
0725|141|I|drugs and herbal products) and share it with your doctor and||
0725|142|I|pharmacist. Do not start, stop, or change the dosage of any||
0725|143|I|medicines without your doctor's approval.||
0725|144|I|   Some products that may interact with this drug include: diet||
0725|145|I|pills/appetite suppressants (such as diethylpropion), drugs for||
0725|146|I|attention deficit disorder (such as atomoxetine,||
0725|147|I|methylphenidate), apraclonidine, bupropion, buspirone,||
0725|148|I|carbamazepine, cyclobenzaprine, deutetrabenazine,||
0725|149|I|dextromethorphan, methyldopa, metoclopramide, certain supplements||
0725|150|I|(such as tryptophan, tyramine), tetrabenazine, certain "triptans"||
0725|151|I|used to treat migraine headaches (such as rizatriptan,||
0725|152|I|sumatriptan, zolmitriptan), valbenazine.||
0725|153|I|   The risk of serotonin syndrome/toxicity increases if you are||
0725|154|I|also taking other drugs that increase serotonin. Examples include||
0725|155|I|street drugs such as MDMA/"ecstasy," St. John's wort, tramadol,||
0725|156|I|certain opioid medications (such as fentanyl, meperidine,||
0725|157|I|methadone, tapentadol), certain antidepressants (including||
0725|158|I|maprotiline, mirtazapine, SSRIs such as fluoxetine/paroxetine,||
0725|159|I|SNRIs such as duloxetine/venlafaxine, tricyclics such as||
0725|160|I|amitriptyline/doxepin), among others. The risk of serotonin||
0725|161|I|syndrome/toxicity may be more likely when you start or increase||
0725|162|I|the dose of these drugs.||
0725|163|I|   Some products can interact with rasagiline if you take them||
0725|164|I|together, or even if you take them weeks before or after taking||
0725|165|I|rasagiline. Tell your doctor or pharmacist if you take anything||
0725|166|I|in the list of products that may interact with this drug, or any||
0725|167|I|of the products that increase serotonin, within 2 weeks before or||
0725|168|I|after taking rasagiline. Also tell them if you have taken||
0725|169|I|fluoxetine within 5 weeks before starting rasagiline. Ask your||
0725|170|I|doctor how much time to wait between starting or stopping any of||
0725|171|I|these drugs and starting rasagiline.||
0725|172|I|   Taking other MAO inhibitors with this medication may cause a||
0725|173|I|serious (possibly fatal) drug interaction. Do not take any other||
0725|174|I|MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene||
0725|175|I|blue, moclobemide, phenelzine, procarbazine, safinamide,||
0725|176|I|selegiline, tranylcypromine) during treatment with this||
0725|177|I|medication. Most MAO inhibitors should also not be taken for two||
0725|178|I|weeks before and after treatment with this medication. Ask your||
0725|179|I|doctor when to start or stop taking this medication.||
0725|180|I|   Before using rasagiline, report the use of drugs that may||
0725|181|I|increase the risk of extremely high blood pressure (hypertensive||
0725|182|I|crisis) when combined with rasagiline, including herbal products||
0725|183|I|(such as ephedra/ma Huang), allergy and cough-and-cold products||
0725|184|I|(including dextromethorphan, decongestants such as||
0725|185|I|phenylephrine/pseudoephedrine), and stimulants (such as||
0725|186|I|amphetamines, ephedrine, epinephrine, phenylalanine). Rasagiline||
0725|187|I|should not be used with any of these medications. Talk to your||
0725|188|I|doctor or pharmacist for more details.||
0725|189|I|   Tell your doctor or pharmacist if you are taking other||
0725|190|I|products that cause drowsiness including alcohol, marijuana||
0725|191|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0725|192|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0725|193|I|zolpidem), muscle relaxants (such as carisoprodol), and opioid||
0725|194|I|pain relievers (such as codeine, hydrocodone).||
0725|195|B|||
0725|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0725|197|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0725|198|O|poison control center right away. US residents can call||
0725|199|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0725|200|O|Symptoms of overdose may not appear for up to 12 hours and may||
0725|201|O|include: irritability, restlessness, dizziness, drowsiness,||
0725|202|O|sweating, fast heartbeat, headache, confusion, seizures.||
0725|203|B|||
0725|204|N|NOTES:  Do not share this medication with others.||
0725|205|N|   Lab and/or medical tests (such as blood pressure) will be done||
0725|206|N|while you are taking this medication. Keep all medical and lab||
0725|207|N|appointments.||
0725|208|B|||
0725|209|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0725|210|D|remember. If it is near the time of the next dose, skip the||
0725|211|D|missed dose. Take your next dose at the regular time. Do not||
0725|212|D|double the dose to catch up.||
0725|213|B|||
0725|214|R|STORAGE:  Store at room temperature away from light and moisture.||
0725|215|R|Do not store in the bathroom. Keep all medications away from||
0725|216|R|children and pets.||
0725|217|R|   Do not flush medications down the toilet or pour them into a||
0725|218|R|drain unless instructed to do so. Properly discard this product||
0725|219|R|when it is expired or no longer needed. Consult your pharmacist||
0725|220|R|or local waste disposal company.||
0725|221|B|||
0725|222|A|Information last revised August 2024.||
0725|223|A|Copyright(c) 2025 First Databank, Inc.||
0725|224|B|||
0726|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0726|002|Z|does NOT have all possible information about this product. This||
0726|003|Z|information does not assure that this product is safe, effective,||
0726|004|Z|or appropriate for you. This information is not individual||
0726|005|Z|medical advice and does not substitute for the advice of your||
0726|006|Z|health care professional. Always ask your health care||
0726|007|Z|professional for complete information about this product and your||
0726|008|Z|specific health needs.||
0726|009|B|||
0726|010|T|SODIUM FLUORIDE/POTASSIUM NITRATE TOOTHPASTE - DENTAL||
0726|011|F|(SO-dee-um FLOOR-ide/poh-TASS-ee-um NYE-trate)||
0726|012|B|||
0726|013|C|COMMON BRAND NAME(S): Prevident 5000 Sensitive||
0726|014|B|||
0726|015|U|USES:  This medication is used to prevent cavities and to reduce||
0726|016|U|pain from sensitive teeth (dentinal hypersensitivity). Sodium||
0726|017|U|fluoride works by making the teeth stronger and more resistant to||
0726|018|U|decay caused by acid and bacteria. Potassium nitrate works by||
0726|019|U|calming the nerves in the teeth.||
0726|020|U|   Do not use this medication in children younger than 6 years||
0726|021|U|old unless directed by your doctor/dentist. Some products are not||
0726|022|U|recommended for use in children younger than 12 years. Ask your||
0726|023|U|doctor or dentist for more details about using this product||
0726|024|U|safely in children. Caregivers/parents should watch the child to||
0726|025|U|make sure the child does not swallow the medication while||
0726|026|U|brushing.||
0726|027|B|||
0726|028|H|HOW TO USE:  Use this medication as directed by your||
0726|029|H|doctor/dentist, usually twice daily (in the morning and evening).||
0726|030|H|   Use this medication in place of your regular toothpaste unless||
0726|031|H|otherwise directed by your doctor/dentist. Apply at least a 1||
0726|032|H|inch (2.5 centimeters) strip of the medication to a soft-bristled||
0726|033|H|toothbrush, and brush your teeth for at least 1 minute. Spit out||
0726|034|H|the medication after use. Some products recommend rinsing your||
0726|035|H|mouth thoroughly after use. If you are using the gel form of the||
0726|036|H|toothpaste, children should rinse their mouth thoroughly right||
0726|037|H|away after brushing. For adults, do not rinse your mouth, eat, or||
0726|038|H|drink for at least 30 minutes after use to get the best results.||
0726|039|H|   Do not swallow the medication. Make sure to brush all||
0726|040|H|sensitive areas of the teeth.||
0726|041|H|   Use this medication regularly in order to get the most benefit||
0726|042|H|from it. To help you remember, use it at the same times each day.||
0726|043|H|   Do not use this medication for longer than 4 weeks unless||
0726|044|H|directed by your doctor/dentist. Sensitive/painful teeth may||
0726|045|H|sometimes be a symptom of a serious problem that needs attention||
0726|046|H|from a dentist.||
0726|047|H|   Tell your doctor/dentist if your symptoms last or get worse.||
0726|048|B|||
0726|049|S|SIDE EFFECTS:  Mouth/gum irritation may rarely occur. If this||
0726|050|S|effect lasts or gets worse, contact your doctor/dentist or||
0726|051|S|pharmacist promptly.||
0726|052|S|   Tell your doctor/dentist right away if your teeth become||
0726|053|S|stained or pitted. This is often a result of too much fluoride.||
0726|054|S|   Remember that this medication has been prescribed because your||
0726|055|S|doctor has judged that the benefit to you is greater than the||
0726|056|S|risk of side effects. Many people using this medication do not||
0726|057|S|have serious side effects.||
0726|058|S|   A very serious allergic reaction to this drug is rare.||
0726|059|S|However, get medical help right away if you notice any symptoms||
0726|060|S|of a serious allergic reaction, including: rash, itching/swelling||
0726|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0726|062|S|breathing.||
0726|063|S|   This is not a complete list of possible side effects. If you||
0726|064|S|notice other effects not listed above, contact your||
0726|065|S|doctor/dentist or pharmacist.||
0726|066|S|   In the US -||
0726|067|S|   Call your doctor for medical advice about side effects. You||
0726|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0726|069|S|www.fda.gov/medwatch.||
0726|070|S|   In Canada - Call your doctor for medical advice about side||
0726|071|S|effects. You may report side effects to Health Canada at||
0726|072|S|1-866-234-2345.||
0726|073|B|||
0726|074|P|PRECAUTIONS:  Before using this medication, tell your||
0726|075|P|doctor/dentist or pharmacist if you are allergic to sodium||
0726|076|P|fluoride or potassium nitrate; or if you have any other||
0726|077|P|allergies. This product may contain inactive ingredients, which||
0726|078|P|can cause allergic reactions or other problems. Talk to your||
0726|079|P|pharmacist for more details.||
0726|080|P|   Before using this medication, tell your doctor/dentist or||
0726|081|P|pharmacist your medical history, especially of: mouth problems||
0726|082|P|(such as sores, mucositis).||
0726|083|P|   Tell your doctor if you are pregnant before using this||
0726|084|P|medication.||
0726|085|P|   It is unknown if this medication passes into breast milk.||
0726|086|P|However, it is unlikely to pass into breast milk. Consult your||
0726|087|P|doctor before breastfeeding.||
0726|088|B|||
0726|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0726|090|I|medications work or increase your risk for serious side effects.||
0726|091|I|This document does not contain all possible drug interactions.||
0726|092|I|Keep a list of all the products you use (including||
0726|093|I|prescription/nonprescription drugs and herbal products) and share||
0726|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
0726|095|I|the dosage of any medicines without your doctor's approval.||
0726|096|B|||
0726|097|O|OVERDOSE:  This medication may be harmful if swallowed in large||
0726|098|O|amounts. If someone has overdosed and has serious symptoms such||
0726|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0726|100|O|poison control center right away. US residents can call||
0726|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0726|102|O|Symptoms of overdose may include: burning in the mouth, sore||
0726|103|O|tongue, nausea/vomiting, diarrhea, increased saliva, stomach||
0726|104|O|pain/cramping, muscle weakness, shaking, seizures.||
0726|105|B|||
0726|106|N|NOTES:  Do not share this medication with others.||
0726|107|N|   Using this medication does not replace good dental habits.||
0726|108|N|Continue to floss your teeth regularly as directed by your||
0726|109|N|dentist, and have regular dental checkups.||
0726|110|N|   Sensitive teeth can be caused by damage to the hard outside||
0726|111|N|surface of the tooth (enamel). Avoid acidic food/drinks (such as||
0726|112|N|ginger ale, limes/lemons, citrus-based drinks, coffee), which can||
0726|113|N|damage the tooth enamel. Consult your doctor/dentist for more||
0726|114|N|details.||
0726|115|B|||
0726|116|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0726|117|D|If it is near the time of the next dose, skip the missed dose.||
0726|118|D|Use your next dose at the regular time. Do not double the dose to||
0726|119|D|catch up.||
0726|120|B|||
0726|121|R|STORAGE:  Store at room temperature. Keep all medications away||
0726|122|R|from children and pets.||
0726|123|R|   Do not flush medications down the toilet or pour them into a||
0726|124|R|drain unless instructed to do so. Properly discard this product||
0726|125|R|when it is expired or no longer needed. Consult your pharmacist||
0726|126|R|or local waste disposal company.||
0726|127|B|||
0726|128|A|Information last revised May 2024.||
0726|129|A|Copyright(c) 2025 First Databank, Inc.||
0726|130|B|||
0727|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0727|002|Z|does NOT have all possible information about this product. This||
0727|003|Z|information does not assure that this product is safe, effective,||
0727|004|Z|or appropriate for you. This information is not individual||
0727|005|Z|medical advice and does not substitute for the advice of your||
0727|006|Z|health care professional. Always ask your health care||
0727|007|Z|professional for complete information about this product and your||
0727|008|Z|specific health needs.||
0727|009|B|||
0727|010|T|LEVONORGESTREL/ETHINYL ESTRADIOL-EE 13 WEEK CONTRACEPTIVE - ORAL||
0727|011|F|(LEE-voe-nor-JES-trel/ETH-in-il es-tra-DYE-ole)||
0727|012|B|||
0727|013|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
0727|014|W|tobacco and are over 35 years old. Smoking raises your risk of||
0727|015|W|stroke, heart attack, blood clots, and high blood pressure from||
0727|016|W|hormonal birth control (such as the pill, patch, ring). The risk||
0727|017|W|of these serious problems increases with age and with the number||
0727|018|W|of cigarettes you smoke. Do not smoke or use tobacco.||
0727|019|B|||
0727|020|U|USES:  This combination hormone medication is used to prevent||
0727|021|U|pregnancy. It contains 2 hormones: a progestin (levonorgestrel)||
0727|022|U|and an estrogen (ethinyl estradiol).||
0727|023|U|   Besides preventing pregnancy, birth control pills may make||
0727|024|U|your periods more regular, decrease blood loss and painful||
0727|025|U|periods, decrease your risk of ovarian cysts, and also treat||
0727|026|U|acne.||
0727|027|U|   This medication does not protect against sexually transmitted||
0727|028|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
0727|029|U|an effective barrier method (latex or polyurethane condom/dental||
0727|030|U|dams) during sexual activity will help to decrease your risk of||
0727|031|U|infection.||
0727|032|B|||
0727|033|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0727|034|H|your pharmacist before you start using this product and each time||
0727|035|H|you get a refill. The leaflet contains very important information||
0727|036|H|on when to take your pills and what to do if you miss a dose. If||
0727|037|H|you have any questions, ask your doctor or pharmacist.||
0727|038|H|   Take this medication by mouth as directed by your doctor,||
0727|039|H|usually once daily. Pick a time of day that is easy for you to||
0727|040|H|remember, and take your pill at the same time each day.||
0727|041|H|   It is very important to keep taking this medication exactly as||
0727|042|H|prescribed by your doctor. Follow the package instructions to||
0727|043|H|find the first tablet, start with the first tablet in the pack,||
0727|044|H|and take them in the correct order. Do not skip any doses.||
0727|045|H|Pregnancy is more likely if you miss pills, start a new pack||
0727|046|H|late, or take your pill at a different time of the day than||
0727|047|H|usual.||
0727|048|H|   Vomiting or diarrhea can prevent your birth control pills from||
0727|049|H|working well. If you have vomiting or diarrhea, you may need to||
0727|050|H|use a backup birth control method (such as condoms, spermicide).||
0727|051|H|Follow the directions in the Patient Information Leaflet and||
0727|052|H|check with your doctor or pharmacist for more details.||
0727|053|H|   Taking this medication after your evening meal or at bedtime||
0727|054|H|may help if you have stomach upset or nausea with the medication.||
0727|055|H|You may choose to take this medication at another time of day||
0727|056|H|that is easier for you to remember. No matter what dosing||
0727|057|H|schedule you use, it is very important that you take this||
0727|058|H|medication at the same time each day, 24 hours apart. Ask your||
0727|059|H|doctor or pharmacist if you have any questions.||
0727|060|H|   Begin taking this medication on the first Sunday following the||
0727|061|H|beginning of your menstrual period. If your period begins on a||
0727|062|H|Sunday, begin taking this medication on that day. Your pill pack||
0727|063|H|contains 84 estrogen/progestin pills and 7 estrogen-only pills.||
0727|064|H|Take one estrogen/progestin pill daily for 84 days in a row. The||
0727|065|H|day after you finish all the combination pills, start taking one||
0727|066|H|estrogen-only pill daily for 7 days in a row. You should have||
0727|067|H|your period during the week you are taking the estrogen-only||
0727|068|H|pills. The day after you take the last estrogen-only pill, start||
0727|069|H|a new pack whether or not you have your period. If you do not get||
0727|070|H|your period, consult your doctor.||
0727|071|H|   If this is the first time you are using this medication, use a||
0727|072|H|backup form of non-hormonal birth control (such as condoms,||
0727|073|H|spermicide) for the first 7 days to prevent pregnancy until the||
0727|074|H|medication has enough time to work. If you start on the first day||
0727|075|H|of your period, you do not need to use backup birth control the||
0727|076|H|first week.||
0727|077|H|   Ask your doctor or pharmacist about how to switch from other||
0727|078|H|forms of hormonal birth control (such as patch, other birth||
0727|079|H|control pills) to this product. If any information is unclear,||
0727|080|H|consult the Patient Information Leaflet or your doctor or||
0727|081|H|pharmacist.||
0727|082|B|||
0727|083|S|SIDE EFFECTS:  Nausea, vomiting, headache, bloating, breast||
0727|084|S|tenderness, swelling of the ankles/feet (fluid retention), or||
0727|085|S|weight change may occur. Vaginal bleeding between periods||
0727|086|S|(spotting) may occur, especially during the first few months of||
0727|087|S|use. If any of these effects last or get worse, tell your doctor||
0727|088|S|or pharmacist promptly.||
0727|089|S|   You should not have your period during the 3 months that you||
0727|090|S|are taking the combination pills. Instead, you will have your||
0727|091|S|period once every 3 months, during the week that you are taking||
0727|092|S|the estrogen-only pills. This effect is normal with this product.||
0727|093|S|However, if you do not have your period while taking the||
0727|094|S|estrogen-only pills, contact your doctor for a pregnancy test.||
0727|095|S|   Remember that this medication has been prescribed because your||
0727|096|S|doctor has judged that the benefit to you is greater than the||
0727|097|S|risk of side effects. Many people using this medication do not||
0727|098|S|have serious side effects.||
0727|099|S|   This medication may raise your blood pressure. Check your||
0727|100|S|blood pressure regularly and tell your doctor if the results are||
0727|101|S|high.||
0727|102|S|   Tell your doctor right away if you have any serious side||
0727|103|S|effects, including: lumps in the breast, mental/mood changes||
0727|104|S|(such as new/worsening depression), severe stomach/abdominal||
0727|105|S|pain, unusual changes in vaginal bleeding (such as continuous||
0727|106|S|spotting, sudden heavy bleeding, missed periods), dark urine,||
0727|107|S|yellowing eyes/skin.||
0727|108|S|   This medication may rarely cause serious (sometimes fatal)||
0727|109|S|problems from blood clots (such as heart attack, stroke, blood||
0727|110|S|clots in the lungs or legs). Get medical help right away if you||
0727|111|S|have: chest/jaw/left arm pain, confusion, sudden||
0727|112|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0727|113|S|trouble speaking, shortness of breath/rapid breathing,||
0727|114|S|sudden/severe headaches, unusual sweating, weakness on one side||
0727|115|S|of the body, sudden vision changes.||
0727|116|S|   A very serious allergic reaction to this drug is rare.||
0727|117|S|However, get medical help right away if you notice any symptoms||
0727|118|S|of a serious allergic reaction, including: rash, itching/swelling||
0727|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0727|120|S|breathing.||
0727|121|S|   This is not a complete list of possible side effects. If you||
0727|122|S|notice other effects not listed above, contact your doctor or||
0727|123|S|pharmacist.||
0727|124|S|   In the US -||
0727|125|S|   Call your doctor for medical advice about side effects. You||
0727|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0727|127|S|www.fda.gov/medwatch.||
0727|128|S|   In Canada - Call your doctor for medical advice about side||
0727|129|S|effects. You may report side effects to Health Canada at||
0727|130|S|1-866-234-2345.||
0727|131|B|||
0727|132|P|PRECAUTIONS:  See also Warning section.||
0727|133|P|   Before using this medication, tell your doctor or pharmacist||
0727|134|P|if you are allergic to ethinyl estradiol or levonorgestrel; or to||
0727|135|P|other estrogens or progestins; or if you have any other||
0727|136|P|allergies. This product may contain inactive ingredients, which||
0727|137|P|can cause allergic reactions or other problems. Talk to your||
0727|138|P|pharmacist for more details.||
0727|139|P|   Before using this medication, tell your doctor or pharmacist||
0727|140|P|your medical history, especially of: blood clots (for example, in||
0727|141|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
0727|142|P|C or protein S deficiency), high blood pressure, abnormal breast||
0727|143|P|exam, cancer (especially endometrial or breast cancer), high||
0727|144|P|cholesterol or triglyceride (blood fat) levels, depression,||
0727|145|P|diabetes, family or personal history of a certain swelling||
0727|146|P|disorder (angioedema), gallbladder problems, severe||
0727|147|P|headaches/migraines, heart problems (such as heart valve disease,||
0727|148|P|irregular heartbeat, previous heart attack), history of yellowing||
0727|149|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
0727|150|P|birth control (such as pills, patch), kidney disease, liver||
0727|151|P|disease (including tumors), stroke, swelling (edema), thyroid||
0727|152|P|problems, unexplained vaginal bleeding.||
0727|153|P|   If you have diabetes, this medication may affect your blood||
0727|154|P|sugar. Check your blood sugar regularly as directed and share the||
0727|155|P|results with your doctor. Tell your doctor right away if you have||
0727|156|P|symptoms of high blood sugar such as increased thirst/urination.||
0727|157|P|Your doctor may need to adjust your diabetes medication, exercise||
0727|158|P|program, or diet.||
0727|159|P|   Tell your doctor if you just had or will be having surgery or||
0727|160|P|if you will be confined to a bed or chair for a long time (such||
0727|161|P|as a long plane flight). These conditions increase your risk of||
0727|162|P|getting blood clots, especially if you are using hormonal birth||
0727|163|P|control. You may need to stop this medication for a time or take||
0727|164|P|special precautions.||
0727|165|P|   Before having surgery, tell your doctor or dentist about all||
0727|166|P|the products you use (including prescription drugs,||
0727|167|P|nonprescription drugs, and herbal products).||
0727|168|P|   This medication may cause blotchy, dark areas on your face and||
0727|169|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0727|170|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0727|171|P|wear protective clothing when outdoors.||
0727|172|P|   If you are nearsighted or wear contact lenses, you may develop||
0727|173|P|vision problems or trouble wearing your contact lenses. Contact||
0727|174|P|your eye doctor if these problems occur.||
0727|175|P|   It may take longer for you to become pregnant after you stop||
0727|176|P|taking birth control pills. Consult your doctor.||
0727|177|P|   This medication should not be used during pregnancy. If you||
0727|178|P|become pregnant or think you may be pregnant, tell your doctor||
0727|179|P|right away. If you have just given birth or had a pregnancy||
0727|180|P|loss/abortion after the first 3 months, talk with your doctor||
0727|181|P|about reliable forms of birth control, and find out when it is||
0727|182|P|safe to start using birth control that contains a form of||
0727|183|P|estrogen, such as this medication.||
0727|184|P|   A small amount of this medication passes into breast milk and||
0727|185|P|may have undesirable effects on a nursing infant. Consult your||
0727|186|P|doctor before breastfeeding.||
0727|187|B|||
0727|188|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0727|189|I|medications work or increase your risk for serious side effects.||
0727|190|I|This document does not contain all possible drug interactions.||
0727|191|I|Keep a list of all the products you use (including||
0727|192|I|prescription/nonprescription drugs and herbal products) and share||
0727|193|I|it with your doctor and pharmacist. Do not start, stop, or change||
0727|194|I|the dosage of any medicines without your doctor's approval.||
0727|195|I|   Some products that may interact with this drug include:||
0727|196|I|aromatase inhibitors (such as anastrozole, exemestane),||
0727|197|I|fezolinetant, ospemifene, tamoxifen, tizanidine, tranexamic acid.||
0727|198|I|   Some drugs may cause hormonal birth control to work less well||
0727|199|I|by decreasing the amount of birth control hormones in your body.||
0727|200|I|This effect can result in pregnancy. Examples include||
0727|201|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
0727|202|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
0727|203|I|seizures (such as barbiturates, carbamazepine, felbamate,||
0727|204|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
0727|205|I|nevirapine), among others.||
0727|206|I|   Tell your doctor when you start any new drug, and discuss if||
0727|207|I|you should use reliable backup birth control. Also tell your||
0727|208|I|doctor if you have any new spotting or breakthrough bleeding,||
0727|209|I|because these may be signs that your birth control is not working||
0727|210|I|well.||
0727|211|I|   This medication may interfere with certain lab tests (such as||
0727|212|I|blood clotting factors, thyroid), possibly causing false test||
0727|213|I|results. Make sure lab personnel and all your doctors know you||
0727|214|I|use this drug.||
0727|215|B|||
0727|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0727|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0727|218|O|poison control center right away. US residents can call||
0727|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0727|220|O|Symptoms of overdose may include severe nausea and vomiting,||
0727|221|O|sudden/unusual vaginal bleeding.||
0727|222|B|||
0727|223|N|NOTES:  Do not share this medication with others.||
0727|224|N|   Regular complete physical exams which include lab and/or||
0727|225|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
0727|226|N|Pap smear) should be done while you are taking this medication.||
0727|227|N|Follow your doctor's instructions for examining your breasts, and||
0727|228|N|report any lumps right away. Keep all medical and lab||
0727|229|N|appointments. Consult your doctor for more details.||
0727|230|B|||
0727|231|D|MISSED DOSE:  Refer to the product package information for advice||
0727|232|D|on missed doses. You may need to use backup birth control (such||
0727|233|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
0727|234|D|pharmacist if you have any questions.||
0727|235|D|   If you often forget to take your pills as directed, contact||
0727|236|D|your doctor to discuss switching to another form of birth||
0727|237|D|control.||
0727|238|B|||
0727|239|R|STORAGE:  Store at room temperature away from light and moisture.||
0727|240|R|Do not store in the bathroom. Keep all medications away from||
0727|241|R|children and pets.||
0727|242|R|   Do not flush medications down the toilet or pour them into a||
0727|243|R|drain unless instructed to do so. Properly discard this product||
0727|244|R|when it is expired or no longer needed. Consult your pharmacist||
0727|245|R|or local waste disposal company.||
0727|246|B|||
0727|247|A|Information last revised October 2025.||
0727|248|A|Copyright(c) 2025 First Databank, Inc.||
0727|249|B|||
0728|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0728|002|Z|does NOT have all possible information about this product. This||
0728|003|Z|information does not assure that this product is safe, effective,||
0728|004|Z|or appropriate for you. This information is not individual||
0728|005|Z|medical advice and does not substitute for the advice of your||
0728|006|Z|health care professional. Always ask your health care||
0728|007|Z|professional for complete information about this product and your||
0728|008|Z|specific health needs.||
0728|009|B|||
0728|010|T|VARENICLINE - ORAL||
0728|011|F|(var-EN-i-kleen)||
0728|012|B|||
0728|013|C|COMMON BRAND NAME(S): Chantix||
0728|014|B|||
0728|015|U|USES:  Varenicline is used by adults to help stop smoking. To||
0728|016|U|increase your chance of success, use this medication with a||
0728|017|U|stop-smoking program that includes education, support, and||
0728|018|U|counseling. Quitting smoking lowers your risk of heart and lung||
0728|019|U|disease, as well as cancer. Varenicline works by blocking||
0728|020|U|nicotine's effects in the brain that make you want to smoke.||
0728|021|U|   Discuss the risks and benefits of this medication, as well as||
0728|022|U|other ways to quit smoking (such as nicotine replacement||
0728|023|U|treatment), with your doctor.||
0728|024|B|||
0728|025|H|HOW TO USE:  Read the Medication Guide provided by your||
0728|026|H|pharmacist before you start taking varenicline and each time you||
0728|027|H|get a refill. If you have any questions, ask your doctor or||
0728|028|H|pharmacist.||
0728|029|H|   There are different ways to use varenicline. One way is to set||
0728|030|H|a date to quit smoking before beginning treatment with this drug.||
0728|031|H|Begin taking varenicline as directed by your doctor, 1 to 2 weeks||
0728|032|H|before the quit date. Take one 0.5-milligram tablet once a day||
0728|033|H|for 3 days, then increase to one 0.5-milligram tablet twice a day||
0728|034|H|for 4 days. The dose is slowly increased to lessen the chance of||
0728|035|H|side effects (such as nausea, unusual dreams). It is okay to||
0728|036|H|smoke during this time. Stop smoking on the quit date. Take the||
0728|037|H|dose prescribed by your doctor twice a day for the rest of the||
0728|038|H|treatment period (usually 12 weeks).||
0728|039|H|   Another way to use varenicline is to start taking the drug||
0728|040|H|before you choose a date to quit smoking. Start with the||
0728|041|H|0.5-milligram tablets and increase the dose as directed by your||
0728|042|H|doctor. Pick a date to quit smoking that is between days 8 and 35||
0728|043|H|of treatment. Stop smoking on the date you have chosen. Take the||
0728|044|H|dose prescribed by your doctor for the rest of the treatment||
0728|045|H|period.||
0728|046|H|   If you are not able to pick a quit date, your doctor may||
0728|047|H|direct you to start taking this medication and gradually reduce||
0728|048|H|smoking with a goal to quit by the end of your treatment. Follow||
0728|049|H|your doctor's directions carefully and reduce smoking as||
0728|050|H|directed.||
0728|051|H|   If this medication comes in a dosing package, carefully follow||
0728|052|H|the directions on the dosing package. There are two types of||
0728|053|H|dosing packs: a starting pack and a continuing pack, each||
0728|054|H|containing different strengths of this medication. If this||
0728|055|H|medication comes in a bottle, carefully follow your doctor's||
0728|056|H|directions on the prescription label. If you have any questions||
0728|057|H|about how to take this medication, talk to your doctor or||
0728|058|H|pharmacist.||
0728|059|H|   Take this medication by mouth after eating food and with a||
0728|060|H|full glass of water.||
0728|061|H|   The dosage is based on your medical condition and response to||
0728|062|H|treatment.||
0728|063|H|   Do not increase your dose or take this medication more often||
0728|064|H|than prescribed. Your condition will not improve any faster, and||
0728|065|H|your risk of side effects will increase. Do not take more than 1||
0728|066|H|milligram twice a day.||
0728|067|H|   Take this medication regularly to get the most benefit from||
0728|068|H|it. To help you remember, take it at the same time(s) each day.||
0728|069|H|   Tell your doctor if you continue to smoke after a few weeks of||
0728|070|H|treatment. If you are not able to quit smoking after 12 weeks of||
0728|071|H|treatment, talk to your doctor.||
0728|072|H|   If you are successful and cigarette-free after 12 weeks of||
0728|073|H|treatment, your doctor may recommend another 12 weeks of||
0728|074|H|treatment with varenicline.||
0728|075|B|||
0728|076|S|SIDE EFFECTS:  See also Precautions section.||
0728|077|S|   Nausea, headache, vomiting, drowsiness, gas, constipation,||
0728|078|S|trouble sleeping, unusual dreams, or changes in taste may occur.||
0728|079|S|If any of these effects last or get worse, tell your doctor or||
0728|080|S|pharmacist promptly.||
0728|081|S|   Remember that this medication has been prescribed because your||
0728|082|S|doctor has judged that the benefit to you is greater than the||
0728|083|S|risk of side effects. Many people using this medication do not||
0728|084|S|have serious side effects.||
0728|085|S|   Tell your doctor right away if you have any serious side||
0728|086|S|effects, including: burning feeling in feet/toes, unusual pain in||
0728|087|S|the legs when walking.||
0728|088|S|   Stop taking varenicline and get medical help right away if you||
0728|089|S|have any very serious side effects, including: seizure, symptoms||
0728|090|S|of a heart attack (such as chest/jaw/left arm pain, shortness of||
0728|091|S|breath, unusual sweating), signs of a stroke (such as weakness on||
0728|092|S|one side of the body, trouble speaking, sudden vision changes,||
0728|093|S|confusion), harmful behavior to self/others/property.||
0728|094|S|   Rarely, varenicline may cause serious mental/mood changes,||
0728|095|S|even after stopping the medication. Drinking alcohol while taking||
0728|096|S|this medication may increase the risk for mental/mood changes.||
0728|097|S|Quitting smoking itself may also cause mental/mood changes. Stop||
0728|098|S|taking varenicline and tell your doctor or pharmacist right away||
0728|099|S|if you have symptoms such as depression/suicidal thoughts,||
0728|100|S|agitation, aggression, or other unusual thoughts or behavior.||
0728|101|S|   A very serious allergic reaction to this drug is rare.||
0728|102|S|However, get medical help right away if you notice any symptoms||
0728|103|S|of a serious allergic reaction, including: rash, itching/swelling||
0728|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0728|105|S|breathing.||
0728|106|S|   This is not a complete list of possible side effects. If you||
0728|107|S|notice other effects not listed above, contact your doctor or||
0728|108|S|pharmacist.||
0728|109|S|   In the US -||
0728|110|S|   Call your doctor for medical advice about side effects. You||
0728|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0728|112|S|www.fda.gov/medwatch.||
0728|113|S|   In Canada - Call your doctor for medical advice about side||
0728|114|S|effects. You may report side effects to Health Canada at||
0728|115|S|1-866-234-2345.||
0728|116|B|||
0728|117|P|PRECAUTIONS:  Before taking varenicline, tell your doctor or||
0728|118|P|pharmacist if you are allergic to it; or if you have any other||
0728|119|P|allergies. This product may contain inactive ingredients, which||
0728|120|P|can cause allergic reactions or other problems. Talk to your||
0728|121|P|pharmacist for more details.||
0728|122|P|   Before using this medication, tell your doctor or pharmacist||
0728|123|P|your medical history, especially of: kidney disease, mental/mood||
0728|124|P|disorders (such as schizophrenia, bipolar disorder, depression),||
0728|125|P|heart/blood vessel disease (such as coronary artery disease,||
0728|126|P|peripheral vascular disease, stroke), seizure.||
0728|127|P|   This drug may make you dizzy, drowsy, lose consciousness, or||
0728|128|P|make it difficult to concentrate. Alcohol or marijuana (cannabis)||
0728|129|P|can worsen these effects. Do not drive, use machinery, or do||
0728|130|P|anything that needs alertness until you can do it safely. Talk to||
0728|131|P|your doctor if you are using marijuana (cannabis).||
0728|132|P|   This drug may also make you more sensitive to alcohol||
0728|133|P|(including increased drunkenness, unusual behavior, and limited||
0728|134|P|or no memory of things that happened). Limit alcoholic beverages.||
0728|135|P|Be aware of how alcohol affects you while taking this medication.||
0728|136|P|   During pregnancy, this medication should be used only when||
0728|137|P|clearly needed. Discuss the risks and benefits with your doctor.||
0728|138|P|   It is unknown if this medication passes into breast milk.||
0728|139|P|Consult your doctor before breastfeeding.||
0728|140|B|||
0728|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0728|142|I|medications work or increase your risk for serious side effects.||
0728|143|I|This document does not contain all possible drug interactions.||
0728|144|I|Keep a list of all the products you use (including||
0728|145|I|prescription/nonprescription drugs and herbal products) and share||
0728|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
0728|147|I|the dosage of any medicines without your doctor's approval.||
0728|148|I|   Smoking can affect the way your body removes certain drugs||
0728|149|I|such as insulin, theophylline, warfarin, among others. When you||
0728|150|I|stop smoking, your doses of these drugs may need to be adjusted||
0728|151|I|by your doctor. Tell all your doctors and pharmacists that you||
0728|152|I|are quitting smoking and of all the products you take.||
0728|153|B|||
0728|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0728|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0728|156|O|poison control center right away. US residents can call||
0728|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0728|158|B|||
0728|159|N|NOTES:  Do not share this medication with others.||
0728|160|B|||
0728|161|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0728|162|D|remember. If it is near the time of the next dose, skip the||
0728|163|D|missed dose. Take your next dose at the regular time. Do not||
0728|164|D|double the dose to catch up.||
0728|165|B|||
0728|166|R|STORAGE:  Store at room temperature away from light and moisture.||
0728|167|R|Do not store in the bathroom. Keep all medications away from||
0728|168|R|children and pets.||
0728|169|R|   Do not flush medications down the toilet or pour them into a||
0728|170|R|drain unless instructed to do so. Properly discard this product||
0728|171|R|when it is expired or no longer needed. Consult your pharmacist||
0728|172|R|or local waste disposal company.||
0728|173|B|||
0728|174|A|Information last revised May 2024.||
0728|175|A|Copyright(c) 2025 First Databank, Inc.||
0728|176|B|||
0729|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0729|002|Z|does NOT have all possible information about this product. This||
0729|003|Z|information does not assure that this product is safe, effective,||
0729|004|Z|or appropriate for you. This information is not individual||
0729|005|Z|medical advice and does not substitute for the advice of your||
0729|006|Z|health care professional. Always ask your health care||
0729|007|Z|professional for complete information about this product and your||
0729|008|Z|specific health needs.||
0729|009|B|||
0729|010|T|DOXYCYCLINE 40 MG EXTENDED-RELEASE CAPSULE - ORAL||
0729|011|F|(dox-ee-SYE-kleen)||
0729|012|B|||
0729|013|C|COMMON BRAND NAME(S): Oracea||
0729|014|B|||
0729|015|U|USES:  This medication is used to treat a certain type of skin||
0729|016|U|condition called rosacea. It helps to reduce the number of||
0729|017|U|pimples and bumps on the face, but it may not decrease redness.||
0729|018|U|It works by reducing skin inflammation caused by rosacea.||
0729|019|U|   Although doxycycline belongs to the class of antibiotics known||
0729|020|U|as tetracyclines, this product does not work as an antibiotic||
0729|021|U|because it does not stop the growth of bacteria. Do not use this||
0729|022|U|product to treat any infection, including viral infections (such||
0729|023|U|as the common cold, flu). Use this medication only as prescribed||
0729|024|U|by your doctor.||
0729|025|B|||
0729|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0729|027|H|from your pharmacist before you start using this medication and||
0729|028|H|each time you get a refill. If you have any questions, ask your||
0729|029|H|doctor or pharmacist.||
0729|030|H|   This medication is best taken by mouth on an empty stomach (at||
0729|031|H|least 1 hour before or 2 hours after a meal) as directed by your||
0729|032|H|doctor, usually once daily in the morning. Swallow the capsules||
0729|033|H|whole. Do not crush or chew the capsules. Doing so can release||
0729|034|H|all of the drug at once, increasing the risk of side effects.||
0729|035|H|   Take this medication with a full glass of water (8 ounces/240||
0729|036|H|milliliters) unless directed otherwise. If stomach upset occurs,||
0729|037|H|taking it with food or milk may help. However, doxycycline may||
0729|038|H|not work as well if you take it with food or milk (or anything||
0729|039|H|high in calcium - more details below), so ask your doctor or||
0729|040|H|pharmacist if you may take it that way. Do not lie down for at||
0729|041|H|least 10 minutes after taking this medication.||
0729|042|H|   Take this medication 2 to 3 hours before or after taking any||
0729|043|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
0729|044|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
0729|045|H|sucralfate, vitamins/minerals, dairy products (such as milk,||
0729|046|H|yogurt), and juice with added calcium. These products bind with||
0729|047|H|doxycycline, preventing your body from fully absorbing the drug.||
0729|048|H|   For the best effect, take this antibiotic at evenly spaced||
0729|049|H|times. To help you remember, take it at the same time each day.||
0729|050|H|Do not skip doses or take more of this medication than||
0729|051|H|prescribed.||
0729|052|H|   Tell your doctor if your condition does not get better or if||
0729|053|H|it gets worse.||
0729|054|B|||
0729|055|S|SIDE EFFECTS:  Upset stomach, nausea, diarrhea, or mild headache||
0729|056|S|may occur. If any of these effects last or get worse, notify your||
0729|057|S|doctor or pharmacist promptly.||
0729|058|S|   Remember that this medication has been prescribed because your||
0729|059|S|doctor has judged that the benefit to you is greater than the||
0729|060|S|risk of side effects. Many people using this medication do not||
0729|061|S|have serious side effects.||
0729|062|S|   Tell your doctor right away if you have any serious side||
0729|063|S|effects, including: nausea/vomiting that doesn't stop,||
0729|064|S|difficult/painful swallowing, brown/gray tooth discoloration,||
0729|065|S|blue/gray/brown discoloration of the skin/lips/tongue/gums,||
0729|066|S|unusual tiredness, signs of kidney problems (such as change in||
0729|067|S|the amount of urine), hearing changes (such as ringing in the||
0729|068|S|ears, decreased hearing), severe stomach/abdominal pain.||
0729|069|S|   Tetracycline drugs such as doxycycline may rarely cause||
0729|070|S|increased pressure around the brain (intracranial||
0729|071|S|hypertension-IH). The risk of this side effect is greater for||
0729|072|S|women of childbearing age who are overweight or who have had IH||
0729|073|S|in the past. If IH develops, it usually goes away after||
0729|074|S|doxycycline is stopped; however, there is a chance of permanent||
0729|075|S|vision loss or blindness. Get medical help right away if you||
0729|076|S|have: nausea/vomiting that doesn't stop, headache that is severe||
0729|077|S|or doesn't go away, vision changes (such as blurred/double||
0729|078|S|vision, decreased vision, sudden blindness).||
0729|079|S|   This medication may rarely cause a severe intestinal condition||
0729|080|S|due to a bacteria called C. difficile. This condition may occur||
0729|081|S|during treatment or weeks to months after treatment has stopped.||
0729|082|S|Tell your doctor right away if you develop diarrhea that doesn't||
0729|083|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0729|084|S|stool.||
0729|085|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0729|086|S|products because they may make symptoms worse.||
0729|087|S|   Use of this medication for prolonged or repeated periods may||
0729|088|S|result in oral thrush or a new vaginal yeast infection (fungal||
0729|089|S|infections). Contact your doctor if you notice white patches in||
0729|090|S|your mouth, a change in vaginal discharge, or other new symptoms.||
0729|091|S|   A very serious allergic reaction to this drug is rare.||
0729|092|S|However, get medical help right away if you notice any symptoms||
0729|093|S|of a serious allergic reaction, including: fever that doesn't go||
0729|094|S|away, new or worsening lymph node swelling, rash,||
0729|095|S|itching/swelling (especially of the face/tongue/throat), severe||
0729|096|S|dizziness, trouble breathing.||
0729|097|S|   This is not a complete list of possible side effects. If you||
0729|098|S|notice other effects not listed above, contact your doctor or||
0729|099|S|pharmacist.||
0729|100|S|   In the US -||
0729|101|S|   Call your doctor for medical advice about side effects. You||
0729|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0729|103|S|www.fda.gov/medwatch.||
0729|104|S|   In Canada - Call your doctor for medical advice about side||
0729|105|S|effects. You may report side effects to Health Canada at||
0729|106|S|1-866-234-2345.||
0729|107|B|||
0729|108|P|PRECAUTIONS:  See also Side Effects section.||
0729|109|P|   Before taking doxycycline, tell your doctor or pharmacist if||
0729|110|P|you are allergic to it; or to tetracycline or related drugs (such||
0729|111|P|as minocycline); or if you have any other allergies. This product||
0729|112|P|may contain inactive ingredients, which can cause allergic||
0729|113|P|reactions or other problems. Talk to your pharmacist for more||
0729|114|P|details.||
0729|115|P|   Before using this medication, tell your doctor or pharmacist||
0729|116|P|your medical history, especially of: kidney disease, liver||
0729|117|P|disease, problems swallowing, esophagus problems (such as hiatal||
0729|118|P|hernia, reflux disease-GERD), stomach surgery (such as||
0729|119|P|gastrectomy, gastric bypass surgery), lupus.||
0729|120|P|   Doxycycline may cause live bacterial vaccines (such as typhoid||
0729|121|P|vaccine) to not work well. Tell your health care professional||
0729|122|P|that you are using doxycycline before having any||
0729|123|P|immunizations/vaccinations.||
0729|124|P|   This medication may make you more sensitive to the sun. Limit||
0729|125|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0729|126|P|sunscreen and wear protective clothing when outdoors. Tell your||
0729|127|P|doctor right away if you get sunburned or have skin||
0729|128|P|blisters/redness.||
0729|129|P|   Before having surgery, tell your doctor or dentist about all||
0729|130|P|the products you use (including prescription drugs,||
0729|131|P|nonprescription drugs, and herbal products).||
0729|132|P|   Children younger than 8 years may be more sensitive to the||
0729|133|P|side effects of doxycycline, especially tooth discoloration.||
0729|134|P|Tooth discoloration has also occurred in older children and young||
0729|135|P|adults. Discuss the risks and benefits of this medication with||
0729|136|P|the doctor.||
0729|137|P|   Tell your doctor if you are pregnant or plan to become||
0729|138|P|pregnant. You should not become pregnant while using doxycycline.||
0729|139|P|Doxycycline may harm an unborn baby. If you become pregnant, talk||
0729|140|P|to your doctor right away about the risks and benefits of this||
0729|141|P|medication.||
0729|142|P|   This medication passes into breast milk. Consult your doctor||
0729|143|P|before breastfeeding.||
0729|144|B|||
0729|145|I|DRUG INTERACTIONS:  See also How to Use section.||
0729|146|I|   Drug interactions may change how your medications work or||
0729|147|I|increase your risk for serious side effects. This document does||
0729|148|I|not contain all possible drug interactions. Keep a list of all||
0729|149|I|the products you use (including prescription/nonprescription||
0729|150|I|drugs and herbal products) and share it with your doctor and||
0729|151|I|pharmacist. Do not start, stop, or change the dosage of any||
0729|152|I|medicines without your doctor's approval.||
0729|153|I|   Some products that may interact with this drug include:||
0729|154|I|retinoid medications taken by mouth (such as acitretin,||
0729|155|I|isotretinoin), strontium.||
0729|156|I|   This medication may interfere with certain lab tests, possibly||
0729|157|I|causing false test results. Make sure lab personnel and all your||
0729|158|I|doctors know you use this drug.||
0729|159|B|||
0729|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0729|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0729|162|O|poison control center right away. US residents can call||
0729|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0729|164|B|||
0729|165|N|NOTES:  Do not share this medication with others.||
0729|166|N|   Lab and/or medical tests may be done while you are taking this||
0729|167|N|medication. Keep all medical and lab appointments. Consult your||
0729|168|N|doctor for more details.||
0729|169|B|||
0729|170|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0729|171|D|remember. If it is near the time of the next dose, skip the||
0729|172|D|missed dose. Take your next dose at the regular time. Do not||
0729|173|D|double the dose to catch up.||
0729|174|B|||
0729|175|R|STORAGE:  Store at room temperature away from light and moisture.||
0729|176|R|Do not store in the bathroom. Keep all medications away from||
0729|177|R|children and pets.||
0729|178|R|   Do not flush medications down the toilet or pour them into a||
0729|179|R|drain unless instructed to do so. Properly discard this product||
0729|180|R|when it is expired or no longer needed. Taking outdated||
0729|181|R|tetracycline-related drugs can result in serious illness. Consult||
0729|182|R|your pharmacist or local waste disposal company.||
0729|183|B|||
0729|184|A|Information last revised September 2025.||
0729|185|A|Copyright(c) 2025 First Databank, Inc.||
0729|186|B|||
0731|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0731|002|Z|does NOT have all possible information about this product. This||
0731|003|Z|information does not assure that this product is safe, effective,||
0731|004|Z|or appropriate for you. This information is not individual||
0731|005|Z|medical advice and does not substitute for the advice of your||
0731|006|Z|health care professional. Always ask your health care||
0731|007|Z|professional for complete information about this product and your||
0731|008|Z|specific health needs.||
0731|009|B|||
0731|010|T|BETAMETHASONE DIPROPIONATE AUGMENTED - TOPICAL||
0731|011|F|(BAY-ta-METH-a-sone dye-PROP-pee-on-ate)||
0731|012|B|||
0731|013|C|COMMON BRAND NAME(S): Diprolene||
0731|014|B|||
0731|015|U|USES:  This medication is used to treat a variety of skin||
0731|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0731|017|U|Betamethasone reduces the swelling, itching, and redness that can||
0731|018|U|occur in these types of conditions. This medication is a strong||
0731|019|U|to very strong (high- to super-high-potency) corticosteroid. The||
0731|020|U|strength depends on the form (cream, gel, or ointment) that you||
0731|021|U|use. For details on the strength of your product, ask your||
0731|022|U|pharmacist.||
0731|023|B|||
0731|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0731|025|H|from your pharmacist before you start using this medication and||
0731|026|H|each time you get a refill. If you have any questions, ask your||
0731|027|H|doctor or pharmacist.||
0731|028|H|   Use this medication on the skin only. However, do not use it||
0731|029|H|on the face, groin, or underarms or for diaper rash unless||
0731|030|H|directed to do so by your doctor.||
0731|031|H|   Wash and dry your hands. Before applying the medication, clean||
0731|032|H|and dry the affected area. Apply a thin film of the medication to||
0731|033|H|the affected area and gently rub in as directed by your doctor,||
0731|034|H|usually 1 to 2 times daily. Do not cover, bandage, or wrap the||
0731|035|H|area.||
0731|036|H|   After applying the medication, wash your hands unless you are||
0731|037|H|using this medication to treat the hands. When applying this||
0731|038|H|medication near the eyes, avoid getting it in the eyes as this||
0731|039|H|may worsen or cause glaucoma. Also, avoid getting this medication||
0731|040|H|in the nose or mouth. If you get the medication in these areas,||
0731|041|H|rinse with plenty of water.||
0731|042|H|   Use this medication only for the condition prescribed. Do not||
0731|043|H|use it for longer than 2 weeks in a row or use more than 50 grams||
0731|044|H|of the gel or more than 45 grams of the cream/ointment per week||
0731|045|H|unless directed to do so by your doctor.||
0731|046|H|   Tell your doctor if your condition lasts or gets worse after 2||
0731|047|H|weeks.||
0731|048|B|||
0731|049|S|SIDE EFFECTS:  Burning, itching, irritation, or dryness at the||
0731|050|S|application site may occur when this medication is first applied||
0731|051|S|to the skin. This should disappear in a few days as your body||
0731|052|S|adjusts to the medication. If any of these effects last or get||
0731|053|S|worse, notify your doctor or pharmacist promptly.||
0731|054|S|   Remember that this medication has been prescribed because your||
0731|055|S|doctor has judged that the benefit to you is greater than the||
0731|056|S|risk of side effects. Many people using this medication do not||
0731|057|S|have serious side effects.||
0731|058|S|   Tell your doctor right away if you have any serious side||
0731|059|S|effects, including: stretch marks, skin thinning/discoloration,||
0731|060|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0731|061|S|(folliculitis).||
0731|062|S|   Skin infections can become worse when this medication is used.||
0731|063|S|Tell your doctor if redness, swelling, or irritation does not||
0731|064|S|improve.||
0731|065|S|   Rarely, it is possible this medication will be absorbed from||
0731|066|S|the skin into the bloodstream. This can lead to side effects of||
0731|067|S|too much corticosteroid. These side effects are more likely in||
0731|068|S|children, and in people who use this medication for a long time||
0731|069|S|or over large areas of the skin. Tell your doctor right away if||
0731|070|S|any of the following side effects occur: unusual/extreme||
0731|071|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0731|072|S|thirst/urination, vision problems.||
0731|073|S|   A very serious allergic reaction to this drug is rare.||
0731|074|S|However, get medical help right away if you notice any symptoms||
0731|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0731|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0731|077|S|breathing.||
0731|078|S|   This is not a complete list of possible side effects. If you||
0731|079|S|notice other effects not listed above, contact your doctor or||
0731|080|S|pharmacist.||
0731|081|S|   In the US -||
0731|082|S|   Call your doctor for medical advice about side effects. You||
0731|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0731|084|S|www.fda.gov/medwatch.||
0731|085|S|   In Canada - Call your doctor for medical advice about side||
0731|086|S|effects. You may report side effects to Health Canada at||
0731|087|S|1-866-234-2345.||
0731|088|B|||
0731|089|P|PRECAUTIONS:  Before using betamethasone, tell your doctor or||
0731|090|P|pharmacist if you are allergic to it; or to other corticosteroids||
0731|091|P|(such as hydrocortisone, prednisone); or if you have any other||
0731|092|P|allergies. This product may contain inactive ingredients, which||
0731|093|P|can cause allergic reactions or other problems. Talk to your||
0731|094|P|pharmacist for more details.||
0731|095|P|   Before using this medication, tell your doctor or pharmacist||
0731|096|P|your medical history, especially of: poor blood circulation,||
0731|097|P|immune system problems, certain skin conditions if using the gel||
0731|098|P|(rosacea, perioral dermatitis).||
0731|099|P|   Do not use if there is an infection or sore present in the||
0731|100|P|area to be treated.||
0731|101|P|   Rarely, using corticosteroid medications for a long time or||
0731|102|P|over large areas of skin can make it more difficult for your body||
0731|103|P|to respond to physical stress. Before having surgery or emergency||
0731|104|P|treatment, or if you get a serious illness/injury, tell your||
0731|105|P|doctor or dentist that you are using this medication or have used||
0731|106|P|this medication within the past few months.||
0731|107|P|   Though it is unlikely, this medication may temporarily slow||
0731|108|P|down a child's growth if used for a long time. See the doctor||
0731|109|P|regularly so your child's height can be checked.||
0731|110|P|   During pregnancy, this medication should be used only when||
0731|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
0731|112|P|   It is unknown if this drug passes into breast milk. Similar||
0731|113|P|medications pass into breast milk. Consult your doctor before||
0731|114|P|breastfeeding.||
0731|115|B|||
0731|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0731|117|I|medications work or increase your risk for serious side effects.||
0731|118|I|This document does not contain all possible drug interactions.||
0731|119|I|Keep a list of all the products you use (such as||
0731|120|I|prescription/nonprescription drugs and herbal products) and share||
0731|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
0731|122|I|the dosage of any medicines without your doctor's approval.||
0731|123|B|||
0731|124|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0731|125|O|has overdosed and has serious symptoms such as passing out or||
0731|126|O|trouble breathing, call 911. Otherwise, call a poison control||
0731|127|O|center right away. US residents can call 1-800-222-1222. Canada||
0731|128|O|residents can call 1-844-764-7669.||
0731|129|B|||
0731|130|N|NOTES:  Do not share this medication with others.||
0731|131|N|   This medication has been prescribed for your current condition||
0731|132|N|only. Do not use it later for other skin problems unless told to||
0731|133|N|do so by your doctor. A different medication may be necessary in||
0731|134|N|those cases.||
0731|135|N|   Lab and/or medical tests (such as adrenal gland function) may||
0731|136|N|be done while you are using this medication, especially if you||
0731|137|N|use this drug for an extended period of time or apply it over||
0731|138|N|large areas of the body. Keep all medical and lab appointments.||
0731|139|N|Consult your doctor for more details.||
0731|140|B|||
0731|141|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0731|142|D|If it is near the time of the next dose, skip the missed dose.||
0731|143|D|Use your next dose at the regular time. Do not double the dose to||
0731|144|D|catch up.||
0731|145|B|||
0731|146|R|STORAGE:  Store at room temperature. Keep all medications away||
0731|147|R|from children and pets.||
0731|148|R|   Do not flush medications down the toilet or pour them into a||
0731|149|R|drain unless instructed to do so. Properly discard this product||
0731|150|R|when it is expired or no longer needed. Consult your pharmacist||
0731|151|R|or local waste disposal company.||
0731|152|B|||
0731|153|A|Information last revised October 2024.||
0731|154|A|Copyright(c) 2025 First Databank, Inc.||
0731|155|B|||
0732|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0732|002|Z|does NOT have all possible information about this product. This||
0732|003|Z|information does not assure that this product is safe, effective,||
0732|004|Z|or appropriate for you. This information is not individual||
0732|005|Z|medical advice and does not substitute for the advice of your||
0732|006|Z|health care professional. Always ask your health care||
0732|007|Z|professional for complete information about this product and your||
0732|008|Z|specific health needs.||
0732|009|B|||
0732|010|T|MORPHINE 20 MG/ML CONCENTRATE - ORAL||
0732|011|F|(MOR-feen)||
0732|012|B|||
0732|013|C|COMMON BRAND NAME(S): Roxanol||
0732|014|B|||
0732|015|W|WARNING:  This product is very strong. It should only be used if||
0732|016|W|you have been regularly taking moderate to large amounts of an||
0732|017|W|opioid pain medication. This strength may cause overdose (even||
0732|018|W|death) if taken by a person who has not been regularly taking||
0732|019|W|opioids. Each milliliter of this product contains 20 milligrams||
0732|020|W|of morphine. Do not confuse this product with other strengths of||
0732|021|W|morphine liquid. Also do not confuse the dose of morphine liquid||
0732|022|W|in milligrams (mg) with the dose in milliliters (mL). (See also||
0732|023|W|How to Use section.)||
0732|024|W|   Ask your doctor or pharmacist if you should have medication||
0732|025|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0732|026|W|Teach your family or household members about the signs of an||
0732|027|W|opioid overdose and how to treat it.||
0732|028|W|   Morphine has a risk for abuse and addiction, which can lead to||
0732|029|W|overdose and death. Morphine may also cause severe, possibly||
0732|030|W|fatal, breathing problems. To lower your risk, your doctor should||
0732|031|W|have you take the smallest dose of morphine that works, and take||
0732|032|W|it for the shortest possible time. See also How to Use section||
0732|033|W|for more information about addiction.||
0732|034|W|   The risk for severe breathing problems is higher when you||
0732|035|W|start this medication and after a dose increase, or if you take||
0732|036|W|the wrong dose/strength. Taking this medication with alcohol or||
0732|037|W|other drugs that can cause drowsiness or breathing problems may||
0732|038|W|cause very serious side effects, including death. Be sure you||
0732|039|W|know how to take morphine and what other drugs you should avoid||
0732|040|W|taking with it. See also Drug Interactions section. Get medical||
0732|041|W|help right away if any of these very serious side effects occur:||
0732|042|W|slow/shallow breathing, unusual lightheadedness, severe||
0732|043|W|drowsiness/dizziness, difficulty waking up.||
0732|044|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0732|045|W|or abuse. If someone accidentally swallows this drug, get medical||
0732|046|W|help right away.||
0732|047|W|   Before using this medication, women of childbearing age should||
0732|048|W|talk with their doctor(s) about the risks and benefits. Tell your||
0732|049|W|doctor if you are pregnant or if you plan to become pregnant.||
0732|050|W|During pregnancy, this medication should be used only when||
0732|051|W|clearly needed. It may slightly increase the risk of birth||
0732|052|W|defects if used during the first two months of pregnancy. Also,||
0732|053|W|using it for a long time or in high doses near the expected||
0732|054|W|delivery date may harm the unborn baby. To lessen the risk, take||
0732|055|W|the smallest effective dose for the shortest possible time.||
0732|056|W|Babies born to mothers who use this drug for a long time may||
0732|057|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0732|058|W|doctor right away if you notice any symptoms in your newborn baby||
0732|059|W|such as crying that doesn't stop, slow/shallow breathing,||
0732|060|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0732|061|W|difficulty gaining weight.||
0732|062|B|||
0732|063|U|USES:  Morphine is used to help relieve severe pain. It belongs||
0732|064|U|to a class of drugs known as opioid analgesics. It works in the||
0732|065|U|brain to change how your body feels and responds to pain.||
0732|066|B|||
0732|067|H|HOW TO USE:  See also Warning section.||
0732|068|H|   Read the Medication Guide provided by your pharmacist before||
0732|069|H|you start using morphine and each time you get a refill. If you||
0732|070|H|have any questions, ask your doctor or pharmacist.||
0732|071|H|   Take this medication by mouth as directed by your doctor. Ask||
0732|072|H|your pharmacist or doctor to show you the right way to measure||
0732|073|H|your dose. Carefully measure the dose using the medicine dropper||
0732|074|H|or oral syringe provided. Do not use a household spoon because||
0732|075|H|you may not get the correct dose.||
0732|076|H|   You may take this drug with or without food. If you have||
0732|077|H|nausea, it may help to take this drug with food. Ask your doctor||
0732|078|H|or pharmacist about other ways to decrease nausea (such as lying||
0732|079|H|down for 1 to 2 hours with as little head movement as possible).||
0732|080|H|   The dosage is based on your medical condition and response to||
0732|081|H|treatment. Do not increase your dose or use this drug more often||
0732|082|H|or for longer than prescribed because your risk of side effects||
0732|083|H|may increase. Properly stop the medication when so directed.||
0732|084|H|   Pain medications work best if they are used as the first signs||
0732|085|H|of pain occur. If you wait until the pain has worsened, the||
0732|086|H|medication may not work as well.||
0732|087|H|   If you have ongoing pain (such as due to cancer), your doctor||
0732|088|H|may direct you to also take long-acting opioid medications. In||
0732|089|H|that case, this medication might be used for sudden||
0732|090|H|(breakthrough) pain only as needed. Other pain relievers (such as||
0732|091|H|acetaminophen, ibuprofen) may also be prescribed with this||
0732|092|H|medication. Ask your doctor or pharmacist about using morphine||
0732|093|H|safely with other drugs.||
0732|094|H|   Suddenly stopping this medication may cause withdrawal,||
0732|095|H|especially if you have used it for a long time or in high doses.||
0732|096|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0732|097|H|Tell your doctor or pharmacist right away if you have any||
0732|098|H|withdrawal symptoms such as restlessness, mental/mood changes||
0732|099|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0732|100|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0732|101|H|aches, or sudden changes in behavior.||
0732|102|H|   When this medication is used for a long time, it may not work||
0732|103|H|as well. Talk with your doctor if this medication stops working||
0732|104|H|well.||
0732|105|H|   Though it helps many people, this medication may sometimes||
0732|106|H|cause addiction. This risk may be higher if you have a||
0732|107|H|mental/mood disorder or a substance use disorder (such as overuse||
0732|108|H|of or addiction to drugs/alcohol). Take this medication exactly||
0732|109|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0732|110|H|pharmacist for more details.||
0732|111|H|   Tell your doctor if your pain does not get better or if it||
0732|112|H|gets worse, or if you have any new pain.||
0732|113|B|||
0732|114|S|SIDE EFFECTS:  See also Warning section.||
0732|115|S|   Nausea, vomiting, constipation, sweating, lightheadedness,||
0732|116|S|dizziness, or drowsiness may occur. If any of these effects last||
0732|117|S|or get worse, tell your doctor or pharmacist promptly.||
0732|118|S|   To prevent constipation, eat dietary fiber, drink enough||
0732|119|S|water, and exercise. You may also need to take a laxative. Ask||
0732|120|S|your pharmacist which type of laxative is right for you.||
0732|121|S|   To reduce the risk of dizziness and lightheadedness, get up||
0732|122|S|slowly when rising from a sitting or lying position.||
0732|123|S|   Remember that this medication has been prescribed because your||
0732|124|S|doctor has judged that the benefit to you is greater than the||
0732|125|S|risk of side effects. Many people using this medication do not||
0732|126|S|have serious side effects.||
0732|127|S|   Tell your doctor right away if you have any serious side||
0732|128|S|effects, including: interrupted breathing during sleep (sleep||
0732|129|S|apnea), mental/mood changes (such as agitation, confusion,||
0732|130|S|hallucinations), stomach/abdominal pain, slow/fast heartbeat,||
0732|131|S|vision changes, difficulty urinating, signs of your adrenal||
0732|132|S|glands not working well (such as loss of appetite, unusual||
0732|133|S|tiredness, weight loss), trouble swallowing.||
0732|134|S|   Get medical help right away if you have any very serious side||
0732|135|S|effects, including: slow/shallow breathing, fainting, seizure,||
0732|136|S|severe drowsiness/difficulty waking up.||
0732|137|S|   A very serious allergic reaction to this drug is rare.||
0732|138|S|However, get medical help right away if you notice any symptoms||
0732|139|S|of a serious allergic reaction, including: rash, itching/swelling||
0732|140|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0732|141|S|breathing.||
0732|142|S|   This is not a complete list of possible side effects. If you||
0732|143|S|notice other effects not listed above, contact your doctor or||
0732|144|S|pharmacist.||
0732|145|S|   In the US -||
0732|146|S|   Call your doctor for medical advice about side effects. You||
0732|147|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0732|148|S|www.fda.gov/medwatch.||
0732|149|S|   In Canada - Call your doctor for medical advice about side||
0732|150|S|effects. You may report side effects to Health Canada at||
0732|151|S|1-866-234-2345.||
0732|152|B|||
0732|153|P|PRECAUTIONS:  Before using morphine, tell your doctor or||
0732|154|P|pharmacist if you are allergic to it; or to other opioid pain||
0732|155|P|medications (such as codeine); or if you have any other||
0732|156|P|allergies. This product may contain inactive ingredients, which||
0732|157|P|can cause allergic reactions or other problems. Talk to your||
0732|158|P|pharmacist for more details.||
0732|159|P|   Before using this medication, tell your doctor or pharmacist||
0732|160|P|your medical history, especially of: brain disorders (such as||
0732|161|P|head injury, tumor, seizures), breathing problems (such as||
0732|162|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0732|163|P|gallbladder disease, kidney disease, liver disease, mental/mood||
0732|164|P|disorders (such as confusion, depression, thoughts of suicide),||
0732|165|P|personal or family history of a substance use disorder (such as||
0732|166|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
0732|167|P|problems (such as blockage, constipation, diarrhea due to||
0732|168|P|infection, paralytic ileus), disease of the pancreas||
0732|169|P|(pancreatitis), difficulty urinating (such as due to enlarged||
0732|170|P|prostate).||
0732|171|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0732|172|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0732|173|P|machinery, or do anything that needs alertness until you can do||
0732|174|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0732|175|P|are using marijuana (cannabis).||
0732|176|P|   Before having surgery, tell your doctor or dentist about all||
0732|177|P|the products you use (including prescription drugs,||
0732|178|P|nonprescription drugs, and herbal products).||
0732|179|P|   Older adults may be more sensitive to the side effects of this||
0732|180|P|drug, especially confusion, dizziness, drowsiness, and||
0732|181|P|slow/shallow breathing.||
0732|182|P|   During pregnancy, this medication should be used only when||
0732|183|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0732|184|P|benefits with your doctor. (See also Warning section.)||
0732|185|P|   This drug passes into breast milk and may have undesirable||
0732|186|P|effects on a nursing infant. Tell the doctor right away if your||
0732|187|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0732|188|P|breathing. Consult your doctor before breastfeeding.||
0732|189|B|||
0732|190|I|DRUG INTERACTIONS:  See also Warning section.||
0732|191|I|   Drug interactions may change how your medications work or||
0732|192|I|increase your risk for serious side effects. This document does||
0732|193|I|not contain all possible drug interactions. Keep a list of all||
0732|194|I|the products you use (including prescription/nonprescription||
0732|195|I|drugs and herbal products) and share it with your doctor and||
0732|196|I|pharmacist. Do not start, stop, or change the dosage of any||
0732|197|I|medicines without your doctor's approval.||
0732|198|I|   Some products that may interact with this drug include:||
0732|199|I|certain pain medications (mixed opioid agonist-antagonists such||
0732|200|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0732|201|I|samidorphan.||
0732|202|I|   The risk of serious side effects (such as slow/shallow||
0732|203|I|breathing, severe drowsiness/dizziness) may be increased if this||
0732|204|I|medication is taken with other products that may also cause||
0732|205|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0732|206|I|if you are taking other products such as other opioid pain or||
0732|207|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0732|208|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0732|209|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0732|210|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0732|211|I|cetirizine, diphenhydramine).||
0732|212|I|   Check the labels on all your medicines (such as allergy or||
0732|213|I|cough-and-cold products) because they may contain ingredients||
0732|214|I|that cause drowsiness. Ask your pharmacist about using those||
0732|215|I|products safely.||
0732|216|I|   This medication may interfere with certain lab tests (such as||
0732|217|I|amylase and lipase levels), possibly causing false test results.||
0732|218|I|Make sure lab personnel and all your doctors know you use this||
0732|219|I|drug.||
0732|220|B|||
0732|221|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0732|222|O|as passing out or trouble breathing, give them naloxone or||
0732|223|O|nalmefene if available, then call 911. If the person is awake and||
0732|224|O|has no symptoms, call a poison control center right away. US||
0732|225|O|residents can call 1-800-222-1222. Canada residents can call||
0732|226|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0732|227|O|breathing, slow heartbeat, severe drowsiness, coma.||
0732|228|B|||
0732|229|N|NOTES:  Do not share this medication with others. Sharing it is||
0732|230|N|against the law.||
0732|231|N|   This medication has been prescribed for your current condition||
0732|232|N|only. Do not use it later for another condition unless your||
0732|233|N|doctor directs you to do so. A different medication may be||
0732|234|N|necessary in that case.||
0732|235|B|||
0732|236|D|MISSED DOSE:  If you are taking this medication on a regular||
0732|237|D|schedule and you miss a dose, take it as soon as you remember. If||
0732|238|D|it is near the time of the next dose, skip the missed dose. Take||
0732|239|D|your next dose at the regular time. Do not double the dose to||
0732|240|D|catch up.||
0732|241|B|||
0732|242|R|STORAGE:  Store at room temperature away from light and moisture.||
0732|243|R|Do not store in the bathroom. Keep all medications away from||
0732|244|R|children and pets. See also Warning section.||
0732|245|R|   Do not flush medications down the toilet or pour them into a||
0732|246|R|drain unless instructed to do so. Properly discard this product||
0732|247|R|when it is expired or no longer needed. For more details, read||
0732|248|R|the Medication Guide, or consult your pharmacist or local waste||
0732|249|R|disposal company.||
0732|250|B|||
0732|251|A|Information last revised August 2025.||
0732|252|A|Copyright(c) 2025 First Databank, Inc.||
0732|253|B|||
0733|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0733|002|Z|does NOT have all possible information about this product. This||
0733|003|Z|information does not assure that this product is safe, effective,||
0733|004|Z|or appropriate for you. This information is not individual||
0733|005|Z|medical advice and does not substitute for the advice of your||
0733|006|Z|health care professional. Always ask your health care||
0733|007|Z|professional for complete information about this product and your||
0733|008|Z|specific health needs.||
0733|009|B|||
0733|010|T|CLOBETASOL/EMOLLIENT - TOPICAL||
0733|011|F|(kloe-BAY-ta-sol/ee-MOL-yunt)||
0733|012|B|||
0733|013|C|COMMON BRAND NAME(S): Temovate E||
0733|014|B|||
0733|015|U|USES:  This medication is used to treat a variety of skin||
0733|016|U|conditions (such as psoriasis, eczema, dermatitis, allergies,||
0733|017|U|rash). Clobetasol reduces the swelling, itching, and redness that||
0733|018|U|can occur in these types of conditions. It also can heal the||
0733|019|U|rough, scaly patches on the skin seen with psoriasis. This||
0733|020|U|medication is a very strong (super-high-potency) corticosteroid.||
0733|021|U|This medication also contains emollients. Emollients soften and||
0733|022|U|moisturize the skin, leading to decreased itching and flaking.||
0733|023|U|Emollients also help to protect the skin against irritation.||
0733|024|B|||
0733|025|H|HOW TO USE:  Use this medication on the skin only. Do not use it||
0733|026|H|on the face, groin, or underarms unless directed to do so by your||
0733|027|H|doctor.||
0733|028|H|   Wash and dry your hands before using. Clean and dry the||
0733|029|H|affected area. Apply a thin film of medication to the affected||
0733|030|H|area and gently rub in as directed by your doctor, usually 2||
0733|031|H|times daily. Do not bandage, cover, or wrap the area unless||
0733|032|H|directed to do so by your doctor.||
0733|033|H|   After applying the medication, wash your hands unless you are||
0733|034|H|using this medication to treat the hands. When applying this||
0733|035|H|medication near the eyes, avoid getting it in the eyes because||
0733|036|H|this may worsen or cause glaucoma. Also, avoid getting this||
0733|037|H|medication in the nose or mouth. If you get the medication in||
0733|038|H|these areas, rinse with plenty of water.||
0733|039|H|   Use this medication only for the condition prescribed. Do not||
0733|040|H|use it for longer than 2 weeks in a row or use more than 50 grams||
0733|041|H|per week unless directed to do so by your doctor.||
0733|042|H|   Tell your doctor if your condition lasts or gets worse after 2||
0733|043|H|weeks.||
0733|044|B|||
0733|045|S|SIDE EFFECTS:  Burning, stinging, itching, dryness, or redness at||
0733|046|S|the application site may occur when first applied to the skin.||
0733|047|S|This should disappear in a few days as your body adjusts to the||
0733|048|S|medication. If any of these effects last or get worse, notify||
0733|049|S|your doctor or pharmacist promptly.||
0733|050|S|   Remember that this medication has been prescribed because your||
0733|051|S|doctor has judged that the benefit to you is greater than the||
0733|052|S|risk of side effects. Many people using this medication do not||
0733|053|S|have serious side effects.||
0733|054|S|   Tell your doctor right away if you have any serious side||
0733|055|S|effects, including: stretch marks, skin thinning/discoloration,||
0733|056|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0733|057|S|(folliculitis).||
0733|058|S|   Skin infections can become worse when this medication is used.||
0733|059|S|Notify your doctor promptly if redness, swelling, or irritation||
0733|060|S|does not improve.||
0733|061|S|   Rarely, it is possible this medication will be absorbed from||
0733|062|S|the skin into the bloodstream. This can lead to side effects of||
0733|063|S|too much corticosteroid. These side effects are more likely in||
0733|064|S|children, and in people who use this medication for a long time||
0733|065|S|or over large areas of the skin. Tell your doctor right away if||
0733|066|S|any of the following side effects occur: unusual/extreme||
0733|067|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0733|068|S|thirst/urination, vision problems.||
0733|069|S|   A very serious allergic reaction to this drug is rare.||
0733|070|S|However, get medical help right away if you notice any symptoms||
0733|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0733|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0733|073|S|breathing.||
0733|074|S|   This is not a complete list of possible side effects. If you||
0733|075|S|notice other effects not listed above, contact your doctor or||
0733|076|S|pharmacist.||
0733|077|S|   In the US -||
0733|078|S|   Call your doctor for medical advice about side effects. You||
0733|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0733|080|S|www.fda.gov/medwatch.||
0733|081|S|   In Canada - Call your doctor for medical advice about side||
0733|082|S|effects. You may report side effects to Health Canada at||
0733|083|S|1-866-234-2345.||
0733|084|B|||
0733|085|P|PRECAUTIONS:  Before using clobetasol, tell your doctor or||
0733|086|P|pharmacist if you are allergic to it; or to other corticosteroids||
0733|087|P|(such as hydrocortisone, prednisone); or if you have any other||
0733|088|P|allergies. This product may contain inactive ingredients, which||
0733|089|P|can cause allergic reactions or other problems. Talk to your||
0733|090|P|pharmacist for more details.||
0733|091|P|   Before using this medication, tell your doctor or pharmacist||
0733|092|P|your medical history, especially of: poor blood circulation,||
0733|093|P|immune system problems, certain skin conditions (rosacea,||
0733|094|P|perioral dermatitis).||
0733|095|P|   Do not use if there is an infection or sore present in the||
0733|096|P|area to be treated.||
0733|097|P|   Rarely, using corticosteroid medications for a long time or||
0733|098|P|over large areas of skin can make it more difficult for your body||
0733|099|P|to respond to physical stress. Before having surgery or emergency||
0733|100|P|treatment, or if you get a serious illness/injury, tell your||
0733|101|P|doctor or dentist that you are using this medication or have used||
0733|102|P|this medication within the past few months.||
0733|103|P|   Though it is unlikely, this medication may temporarily slow||
0733|104|P|down a child's growth if used for a long time. See the doctor||
0733|105|P|regularly so your child's height can be checked.||
0733|106|P|   During pregnancy, this medication should be used only when||
0733|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
0733|108|P|   It is unknown if this drug passes into breast milk when||
0733|109|P|applied to the skin. Similar medications pass into breast milk||
0733|110|P|when taken by mouth. Consult your doctor before breastfeeding.||
0733|111|B|||
0733|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0733|113|I|medications work or increase your risk for serious side effects.||
0733|114|I|This document does not contain all possible drug interactions.||
0733|115|I|Keep a list of all the products you use (including||
0733|116|I|prescription/nonprescription drugs and herbal products) and share||
0733|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
0733|118|I|the dosage of any medicines without your doctor's approval.||
0733|119|B|||
0733|120|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0733|121|O|has overdosed and has serious symptoms such as passing out or||
0733|122|O|trouble breathing, call 911. Otherwise, call a poison control||
0733|123|O|center right away. US residents can call 1-800-222-1222. Canada||
0733|124|O|residents can call 1-844-764-7669.||
0733|125|B|||
0733|126|N|NOTES:  Do not share this medication with others.||
0733|127|N|   This medication has been prescribed for your current condition||
0733|128|N|only. Do not use it later for other skin problems unless told to||
0733|129|N|do so by your doctor. A different medication may be necessary in||
0733|130|N|those cases.||
0733|131|N|   Lab and/or medical tests (such as adrenal gland function) may||
0733|132|N|be done while you are using this medication, especially if you||
0733|133|N|use this drug for an extended period of time or apply it over||
0733|134|N|large areas of the body. Keep all medical and lab appointments.||
0733|135|N|Consult your doctor for more details.||
0733|136|B|||
0733|137|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0733|138|D|If it is near the time of the next dose, skip the missed dose.||
0733|139|D|Use your next dose at the regular time. Do not double the dose to||
0733|140|D|catch up.||
0733|141|B|||
0733|142|R|STORAGE:  Store at room temperature. Do not refrigerate. Keep all||
0733|143|R|medications away from children and pets.||
0733|144|R|   Do not flush medications down the toilet or pour them into a||
0733|145|R|drain unless instructed to do so. Properly discard this product||
0733|146|R|when it is expired or no longer needed. Consult your pharmacist||
0733|147|R|or local waste disposal company.||
0733|148|B|||
0733|149|A|Information last revised October 2024.||
0733|150|A|Copyright(c) 2025 First Databank, Inc.||
0733|151|B|||
0734|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0734|002|Z|does NOT have all possible information about this product. This||
0734|003|Z|information does not assure that this product is safe, effective,||
0734|004|Z|or appropriate for you. This information is not individual||
0734|005|Z|medical advice and does not substitute for the advice of your||
0734|006|Z|health care professional. Always ask your health care||
0734|007|Z|professional for complete information about this product and your||
0734|008|Z|specific health needs.||
0734|009|B|||
0734|010|T|PREDNISOLONE DISINTEGRATING TABLET - ORAL||
0734|011|F|(pred-NIS-oh-lone)||
0734|012|B|||
0734|013|C|COMMON BRAND NAME(S): Orapred ODT||
0734|014|B|||
0734|015|U|USES:  Prednisolone is used to treat conditions such as||
0734|016|U|arthritis, blood disorders, severe allergic reactions, certain||
0734|017|U|cancers, eye conditions, skin/kidney/intestinal/lung diseases,||
0734|018|U|and immune system disorders. It decreases your immune system's||
0734|019|U|response to various diseases to reduce symptoms such as swelling,||
0734|020|U|pain and allergic-type reactions. This medication is a||
0734|021|U|corticosteroid hormone.||
0734|022|U|   Prednisolone may also be used with other medications in||
0734|023|U|hormone disorders.||
0734|024|B|||
0734|025|H|HOW TO USE:  Take this medication with food to prevent stomach||
0734|026|H|upset, as directed by your doctor. This medication is dissolved||
0734|027|H|in the mouth on top of the tongue.||
0734|028|H|   Do not remove the tablet from the blister pack until you are||
0734|029|H|ready to take it. With dry hands, peel back the foil on the||
0734|030|H|blister pack to carefully remove the tablet. Do not push the||
0734|031|H|tablet through the foil because the tablets break easily. Place||
0734|032|H|each dose on the tongue, allowing it to dissolve completely.||
0734|033|H|Swallow your dose with your saliva or with water. Do not crush,||
0734|034|H|split, or break the tablet before taking it.||
0734|035|H|   Follow your dosing instructions carefully. The dosage and||
0734|036|H|length of treatment are based on your medical condition and||
0734|037|H|response to treatment. Different dosing schedules exist for||
0734|038|H|prednisolone. If you are not taking the same dose each day or if||
0734|039|H|you take this medication every other day, it may help to mark||
0734|040|H|your calendar with a reminder. Consult your doctor or pharmacist||
0734|041|H|if you have questions.||
0734|042|H|   Do not stop taking this medication without consulting your||
0734|043|H|doctor. Some conditions may become worse when this drug is||
0734|044|H|suddenly stopped. Your dose may need to be gradually decreased.||
0734|045|H|   If you suddenly stop using this medication, you may have||
0734|046|H|withdrawal symptoms (such as weakness, weight loss, nausea,||
0734|047|H|muscle pain, headache, tiredness, dizziness). To help prevent||
0734|048|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0734|049|H|more likely if you have used prednisolone for a long time or in||
0734|050|H|high doses. Tell your doctor or pharmacist right away if you have||
0734|051|H|withdrawal. See also Precautions section.||
0734|052|H|   Tell your doctor if your condition does not get better or if||
0734|053|H|it gets worse.||
0734|054|B|||
0734|055|S|SIDE EFFECTS:  Nausea, vomiting, heartburn, headache, dizziness,||
0734|056|S|trouble sleeping, appetite changes, increased sweating, or acne||
0734|057|S|may occur. If any of these effects last or get worse, tell your||
0734|058|S|doctor or pharmacist promptly.||
0734|059|S|   Remember that this medication has been prescribed because your||
0734|060|S|doctor has judged that the benefit to you is greater than the||
0734|061|S|risk of side effects. Many people using this medication do not||
0734|062|S|have serious side effects.||
0734|063|S|   This medication may make your blood sugar rise, which can||
0734|064|S|cause or worsen diabetes. Tell your doctor right away if you have||
0734|065|S|symptoms of high blood sugar such as increased thirst/urination.||
0734|066|S|If you already have diabetes, check your blood sugar regularly as||
0734|067|S|directed and share the results with your doctor. Your doctor may||
0734|068|S|need to adjust your diabetes medication, exercise program, or||
0734|069|S|diet.||
0734|070|S|   This medication may lower your ability to fight infections.||
0734|071|S|This may make you more likely to get a serious (rarely fatal)||
0734|072|S|infection or make any infection you have worse. Tell your doctor||
0734|073|S|right away if you have any signs of infection (such as sore||
0734|074|S|throat that doesn't go away, fever, chills, white patches in the||
0734|075|S|mouth).||
0734|076|S|   Tell your doctor right away if you have any serious side||
0734|077|S|effects, including: unusual weight gain, menstrual period||
0734|078|S|changes, bone/joint pain, easy bruising/bleeding, mental/mood||
0734|079|S|changes (such as depression, mood swings, agitation), muscle||
0734|080|S|weakness/pain, puffy face, slow wound healing, swelling of the||
0734|081|S|hands/ankles/feet, thinning skin, unusual hair/skin growth,||
0734|082|S|vision problems, fast/slow/irregular heart beat, symptoms of||
0734|083|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
0734|084|S|black/tarry stools, vomit that looks like coffee grounds),||
0734|085|S|red/purple spots on the skin.||
0734|086|S|   Get medical help right away if you have any very serious side||
0734|087|S|effects, including: seizures.||
0734|088|S|   A very serious allergic reaction to this drug is rare.||
0734|089|S|However, get medical help right away if you notice any symptoms||
0734|090|S|of a serious allergic reaction, including: rash, itching/swelling||
0734|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0734|092|S|breathing.||
0734|093|S|   This is not a complete list of possible side effects. If you||
0734|094|S|notice other effects not listed above, contact your doctor or||
0734|095|S|pharmacist.||
0734|096|S|   In the US -||
0734|097|S|   Call your doctor for medical advice about side effects. You||
0734|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0734|099|S|www.fda.gov/medwatch.||
0734|100|S|   In Canada - Call your doctor for medical advice about side||
0734|101|S|effects. You may report side effects to Health Canada at||
0734|102|S|1-866-234-2345.||
0734|103|B|||
0734|104|P|PRECAUTIONS:  Before taking prednisolone, tell your doctor or||
0734|105|P|pharmacist if you are allergic to it; or to prednisone; or if you||
0734|106|P|have any other allergies. This product may contain inactive||
0734|107|P|ingredients, which can cause allergic reactions or other||
0734|108|P|problems. Talk to your pharmacist for more details.||
0734|109|P|   Before using this medication, tell your doctor or pharmacist||
0734|110|P|your medical history, especially of: bleeding problems, blood||
0734|111|P|clots, brittle bones (osteoporosis), diabetes, eye diseases (such||
0734|112|P|as cataracts, glaucoma, herpes infection of the eye), heart||
0734|113|P|problems (such as recent heart attack, heart failure), high blood||
0734|114|P|pressure, current/past infections (such as those caused by||
0734|115|P|tuberculosis, herpes, fungus, threadworm), kidney disease, liver||
0734|116|P|disease (such as hepatitis B), mental/mood conditions (such as||
0734|117|P|psychosis, anxiety, depression), stomach/intestinal problems||
0734|118|P|(such as ulcer, ulcerative colitis, diverticulitis), seizures, a||
0734|119|P|certain adrenal gland tumor (pheochromocytoma).||
0734|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0734|121|P|can make you more dizzy. Do not drive, use machinery, or do||
0734|122|P|anything that needs alertness until you can do it safely. Talk to||
0734|123|P|your doctor if you are using marijuana (cannabis).||
0734|124|P|   This medication may cause stomach bleeding. Daily use of||
0734|125|P|alcohol while using this medication may increase your risk for||
0734|126|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
0734|127|P|or pharmacist for more information.||
0734|128|P|   Prednisolone can make you more likely to get infections or may||
0734|129|P|make current infections worse. Stay away from anyone who has an||
0734|130|P|infection that may easily spread (such as chickenpox, COVID-19,||
0734|131|P|measles, flu). Talk to your doctor if you have been exposed to an||
0734|132|P|infection or for more details.||
0734|133|P|   Tell your health care professional that you are using||
0734|134|P|prednisolone before having any immunizations, vaccinations, or||
0734|135|P|skin tests. Avoid contact with people who have recently received||
0734|136|P|live vaccines (such as flu vaccine inhaled through the nose).||
0734|137|P|   Before having surgery, tell your doctor or dentist about all||
0734|138|P|the products you use (including prescription drugs,||
0734|139|P|nonprescription drugs, and herbal products).||
0734|140|P|   Using corticosteroid medications for a long time can make it||
0734|141|P|more difficult for your body to respond to physical stress.||
0734|142|P|Before having surgery or emergency treatment, or if you get a||
0734|143|P|serious illness/injury, tell your doctor or dentist that you are||
0734|144|P|using this medication or have used this medication within the||
0734|145|P|past 12 months. Tell your doctor right away if you develop||
0734|146|P|unusual/extreme tiredness or weight loss. If you will be using||
0734|147|P|this medication for a long time, carry a warning card or medical||
0734|148|P|ID bracelet that identifies your use of this medication.||
0734|149|P|   Older adults may be more sensitive to the side effects of this||
0734|150|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
0734|151|P|mental/mood changes (such as confusion).||
0734|152|P|   This medication may slow down a child's growth if used for a||
0734|153|P|long time. Consult the doctor or pharmacist for more details. See||
0734|154|P|the doctor regularly so your child's height and growth can be||
0734|155|P|checked.||
0734|156|P|   During pregnancy, this medication should be used only when||
0734|157|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
0734|158|P|risks and benefits with your doctor. Infants born to mothers who||
0734|159|P|have been using this medication for a long time may have hormone||
0734|160|P|problems. Tell your doctor right away if you notice symptoms such||
0734|161|P|as nausea/vomiting that doesn't stop, severe diarrhea, or||
0734|162|P|weakness in your newborn.||
0734|163|P|   This drug passes into breast milk, but is unlikely to harm a||
0734|164|P|nursing infant. Consult your doctor before breastfeeding.||
0734|165|B|||
0734|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0734|167|I|medications work or increase your risk for serious side effects.||
0734|168|I|This document does not contain all possible drug interactions.||
0734|169|I|Keep a list of all the products you use (including||
0734|170|I|prescription/nonprescription drugs and herbal products) and share||
0734|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
0734|172|I|the dosage of any medicines without your doctor's approval.||
0734|173|I|   Some products that may interact with this drug include:||
0734|174|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
0734|175|I|also cause bleeding/bruising (including antiplatelet drugs such||
0734|176|I|as clopidogrel, "blood thinners" such as warfarin/dabigatran,||
0734|177|I|NSAIDs such as ibuprofen, celecoxib, aspirin, salicylates).||
0734|178|I|   If your doctor has told you to take low-dose aspirin to||
0734|179|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0734|180|I|you should keep taking the aspirin unless your doctor tells you||
0734|181|I|not to. Ask your doctor or pharmacist for more details.||
0734|182|I|   Other medications can affect the removal of prednisolone from||
0734|183|I|your body, which may affect how prednisolone works. Examples||
0734|184|I|include azole antifungals (such as ketoconazole), cyclosporine,||
0734|185|I|estrogens, St. John's wort, some drugs used to treat seizures||
0734|186|I|(such as phenobarbital, phenytoin), among others.||
0734|187|I|   This medication may interfere with certain lab tests (such as||
0734|188|I|skin tests), possibly causing false test results. Make sure lab||
0734|189|I|personnel and all your doctors know you use this drug.||
0734|190|B|||
0734|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0734|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0734|193|O|poison control center right away. US residents can call||
0734|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0734|195|B|||
0734|196|N|NOTES:  Do not share this medication with others.||
0734|197|N|   If this medication is used for a long time, lab and/or medical||
0734|198|N|tests (such as blood sugar/mineral levels, blood pressure, eye||
0734|199|N|exams, bone density tests, height/weight measurements) should be||
0734|200|N|done while you are taking this medication. Keep all medical and||
0734|201|N|lab appointments. Consult your doctor for more details.||
0734|202|N|   This medication may cause bone loss (osteoporosis) when used||
0734|203|N|for a long time. Lifestyle changes that may help reduce the risk||
0734|204|N|of bone problems include doing weight-bearing exercise, stopping||
0734|205|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
0734|206|N|D. Talk to your doctor for more details.||
0734|207|B|||
0734|208|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0734|209|D|remember. If it is near the time of the next dose, skip the||
0734|210|D|missed dose. Take your next dose at the regular time. Do not||
0734|211|D|double the dose to catch up.||
0734|212|D|   If you do not take the same dose each day or if you take this||
0734|213|D|medication every other day, ask your doctor or pharmacist what||
0734|214|D|you should do if you miss a dose.||
0734|215|B|||
0734|216|R|STORAGE:  Store at room temperature away from light and moisture.||
0734|217|R|Do not store in the bathroom. Keep all medications away from||
0734|218|R|children and pets.||
0734|219|R|   Do not flush medications down the toilet or pour them into a||
0734|220|R|drain unless instructed to do so. Properly discard this product||
0734|221|R|when it is expired or no longer needed. Consult your pharmacist||
0734|222|R|or local waste disposal company.||
0734|223|B|||
0734|224|M|MEDICAL ALERT:  Your condition can cause complications in a||
0734|225|M|medical emergency. For information about enrolling in MedicAlert,||
0734|226|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0734|227|B|||
0734|228|A|Information last revised September 2025.||
0734|229|A|Copyright(c) 2025 First Databank, Inc.||
0734|230|B|||
0735|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0735|002|Z|does NOT have all possible information about this product. This||
0735|003|Z|information does not assure that this product is safe, effective,||
0735|004|Z|or appropriate for you. This information is not individual||
0735|005|Z|medical advice and does not substitute for the advice of your||
0735|006|Z|health care professional. Always ask your health care||
0735|007|Z|professional for complete information about this product and your||
0735|008|Z|specific health needs.||
0735|009|B|||
0735|010|T|HUMAN PAPILLOMAVIRUS VACCINE - INJECTION||
0735|011|B|||
0735|012|C|COMMON BRAND NAME(S): Gardasil, Gardasil 9||
0735|013|B|||
0735|014|U|USES:  This vaccine is used to help prevent cancer of the anus,||
0735|015|U|abnormal tissue growth of the anus, genital warts, or certain||
0735|016|U|head and neck cancers. In girls and women, it is also used to||
0735|017|U|prevent cancer of the cervix/vagina/vulva and abnormal tissue||
0735|018|U|growth in these areas that can lead to cancer. These conditions||
0735|019|U|are commonly caused by certain types of human papillomavirus||
0735|020|U|(HPV). This vaccine works by increasing the body's natural||
0735|021|U|defense (immunity) against the virus. This vaccine does not||
0735|022|U|protect against all types of HPV, only the types in the vaccine.||
0735|023|U|   Vaccines may not fully protect everyone who receives them.||
0735|024|B|||
0735|025|H|HOW TO USE:  Read all vaccine information available from your||
0735|026|H|health care professional before receiving the vaccine. If you||
0735|027|H|have any questions, ask your health care professional.||
0735|028|H|   This vaccine is given by injection into the muscle of the||
0735|029|H|thigh or upper arm by a health care professional.||
0735|030|H|   Vaccines are usually given in a series of doses to provide the||
0735|031|H|best protection. Closely follow the vaccination schedule provided||
0735|032|H|by your health care professional. To help you remember, mark your||
0735|033|H|calendar with a reminder.||
0735|034|H|   This vaccine may be given at the same time as other vaccines.||
0735|035|B|||
0735|036|S|SIDE EFFECTS:  Redness/itching/swelling/bruising/pain at the||
0735|037|S|injection site, fever, or headache may occur. If any of these||
0735|038|S|effects last or get worse, tell your health care professional||
0735|039|S|promptly.||
0735|040|S|   Rarely, some people have symptoms such as fainting, dizziness,||
0735|041|S|vision changes, or ringing in the ears just after getting a||
0735|042|S|vaccine injection. Seizure-like movements may also rarely happen||
0735|043|S|after injection with this vaccine. Tell your health care||
0735|044|S|professional right away if you have any of these symptoms.||
0735|045|S|Sitting or lying down may help, since these symptoms usually||
0735|046|S|don't last long.||
0735|047|S|   Remember that this vaccine has been prescribed because your||
0735|048|S|health care professional has judged that the benefit to you is||
0735|049|S|greater than the risk of side effects. Many people using this||
0735|050|S|vaccine do not have serious side effects.||
0735|051|S|   A very serious allergic reaction to this vaccine is rare.||
0735|052|S|However, get medical help right away if you notice any symptoms||
0735|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0735|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0735|055|S|breathing.||
0735|056|S|   This is not a complete list of possible side effects. If you||
0735|057|S|notice other effects not listed above, contact your health care||
0735|058|S|professional.||
0735|059|S|   Contact the health care professional for medical advice about||
0735|060|S|side effects. The following numbers do not provide medical||
0735|061|S|advice, but in the US you may report side effects to the Vaccine||
0735|062|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
0735|063|S|Canada, you may call the Vaccine Safety Section at Public Health||
0735|064|S|Agency of Canada at 1-866-844-0018.||
0735|065|B|||
0735|066|P|PRECAUTIONS:  Before receiving this vaccine, tell the health care||
0735|067|P|professional if you are allergic to it; or if you have any other||
0735|068|P|allergies. This product may contain inactive ingredients (such as||
0735|069|P|yeast), which can cause allergic reactions or other problems.||
0735|070|P|Talk to your health care professional for more details.||
0735|071|P|   Before receiving this vaccine, tell your health care||
0735|072|P|professional your medical history, especially of: current||
0735|073|P|fever/illness, immune system disorders (such as due to HIV||
0735|074|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
0735|075|P|radiation treatment), vaccination history (including previous||
0735|076|P|reactions to any vaccines).||
0735|077|P|   This vaccine is not recommended for use during pregnancy.||
0735|078|P|Consult your health care professional for more details.||
0735|079|P|   It is unknown if this vaccine passes into breast milk. Consult||
0735|080|P|your health care professional before breastfeeding.||
0735|081|B|||
0735|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0735|083|I|medications work or increase your risk for serious side effects.||
0735|084|I|This document does not contain all possible drug interactions.||
0735|085|I|Keep a list of all the products you use (including||
0735|086|I|prescription/nonprescription drugs and herbal products) and share||
0735|087|I|it with your health care professional. Do not start, stop, or||
0735|088|I|change the dosage of any medicines without your doctor's||
0735|089|I|approval.||
0735|090|I|   Some products that may interact with this vaccine are: drugs||
0735|091|I|that weaken the immune system (including cyclosporine,||
0735|092|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
0735|093|I|prednisone).||
0735|094|B|||
0735|095|O|OVERDOSE:  Not applicable.||
0735|096|B|||
0735|097|N|NOTES:  Keep all medical and lab appointments. Getting this||
0735|098|N|vaccine does not replace cervical cancer screening. Continue to||
0735|099|N|have regular obstetrician/gynecologist checkups.||
0735|100|N|   Keep vaccine records for yourself and your children and||
0735|101|N|provide them to the health care professionals to prevent||
0735|102|N|unnecessary re-vaccinations.||
0735|103|B|||
0735|104|D|MISSED DOSE:  It is important that you get each vaccination as||
0735|105|D|scheduled. Ask when you should get each dose and mark your||
0735|106|D|calendar with a reminder. If you miss a dose, call the health||
0735|107|D|care professional to reschedule.||
0735|108|B|||
0735|109|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
0735|110|R|light. Keep all medications away from children and pets.||
0735|111|R|   Do not flush medications down the toilet or pour them into a||
0735|112|R|drain unless instructed to do so. Properly discard this product||
0735|113|R|when it is expired or no longer needed. Consult your pharmacist||
0735|114|R|or local waste disposal company.||
0735|115|B|||
0735|116|A|Information last revised February 2025.||
0735|117|A|Copyright(c) 2025 First Databank, Inc.||
0735|118|B|||
0736|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0736|002|Z|does NOT have all possible information about this product. This||
0736|003|Z|information does not assure that this product is safe, effective,||
0736|004|Z|or appropriate for you. This information is not individual||
0736|005|Z|medical advice and does not substitute for the advice of your||
0736|006|Z|health care professional. Always ask your health care||
0736|007|Z|professional for complete information about this product and your||
0736|008|Z|specific health needs.||
0736|009|B|||
0736|010|T|TRAVOPROST/TIMOLOL SOLUTION - OPHTHALMIC||
0736|011|F|(TRA-voh-prost/TIE-moh-lohl)||
0736|012|B|||
0736|013|U|USES:  This combination product is used to treat high pressure||
0736|014|U|inside the eye due to glaucoma (open-angle type) or other eye||
0736|015|U|diseases (such as ocular hypertension). Lowering high pressure||
0736|016|U|inside the eye helps to prevent blindness. Travoprost is similar||
0736|017|U|to a natural chemical in the body (prostaglandin) and works by||
0736|018|U|controlling the flow of fluid within the eye to maintain a normal||
0736|019|U|pressure. Timolol belongs to a class of drugs known as||
0736|020|U|beta-blockers and works by decreasing the amount of fluid within||
0736|021|U|the eye.||
0736|022|U|   This medication is not recommended as the first medication for||
0736|023|U|treating glaucoma. Your doctor will usually start you on the||
0736|024|U|individual medications first, and then switch you over to this||
0736|025|U|combination product if this is the best combination for you.||
0736|026|B|||
0736|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0736|028|H|from your pharmacist before you start using travoprost/timolol||
0736|029|H|and each time you get a refill. If you have any questions, ask||
0736|030|H|your doctor or pharmacist.||
0736|031|H|   Use this medication in the affected eye(s) as directed by your||
0736|032|H|doctor, usually once a day in the morning.||
0736|033|H|   Remove contact lenses before using this medication because it||
0736|034|H|contains a preservative that can be absorbed by them. Wait at||
0736|035|H|least 15 minutes after using this medication before putting your||
0736|036|H|lenses back in.||
0736|037|H|   Do not use this medication more often because it will not work||
0736|038|H|as well.||
0736|039|H|   To apply eye drops, wash your hands first. To avoid||
0736|040|H|contamination, do not touch the dropper tip or let it touch your||
0736|041|H|eye or any other surface. Tilt your head back, look upward and||
0736|042|H|pull down the lower eyelid to make a pouch. Hold the dropper||
0736|043|H|directly over your eye and place one drop into the pouch. Look||
0736|044|H|downward and gently close your eyes for 1 to 2 minutes. Place one||
0736|045|H|finger at the corner of your eye (near the nose) and apply gentle||
0736|046|H|pressure. This will prevent the medication from draining out. Try||
0736|047|H|not to blink and do not rub your eye. Repeat these steps for your||
0736|048|H|other eye if so directed.||
0736|049|H|   Do not rinse the dropper. Replace the dropper cap after each||
0736|050|H|use.||
0736|051|H|   If you are using another kind of eye medication (such as drops||
0736|052|H|or ointments), wait at least 10 minutes before applying other||
0736|053|H|medications. Use eye drops before eye ointments to allow the eye||
0736|054|H|drops to enter the eye.||
0736|055|H|   Wait several minutes for your vision to clear before driving||
0736|056|H|or operating machinery.||
0736|057|H|   Use this medication regularly in order to get the most benefit||
0736|058|H|from it. Remember to use it at the same time each day. Keep using||
0736|059|H|travoprost/timolol even if you feel well. Most people with||
0736|060|H|glaucoma or high pressure in the eye do not have symptoms.||
0736|061|B|||
0736|062|S|SIDE EFFECTS:  Blurred vision, eye redness/discomfort/itching,||
0736|063|S|feeling as if something is in your eye, dry eyes, watering eyes,||
0736|064|S|eyelid crusting, increase in eyelash number/length/thickness,||
0736|065|S|darkening of the eyelashes and eyelids, eyelid changes, headache,||
0736|066|S|or increased sensitivity to light may occur. If any of these||
0736|067|S|effects last or get worse, notify your doctor or pharmacist||
0736|068|S|promptly.||
0736|069|S|   Travoprost may slowly (over months to years) cause brown||
0736|070|S|discoloration of the colored part of the eye (iris). If you are||
0736|071|S|using this medication in only one eye, only that iris may change||
0736|072|S|color. This color change may be permanent, but the long-term||
0736|073|S|effects are not known. Notify your doctor if this color change||
0736|074|S|occurs, and schedule regular eye exams to monitor it.||
0736|075|S|   Remember that this medication has been prescribed because your||
0736|076|S|doctor has judged that the benefit to you is greater than the||
0736|077|S|risk of side effects. Many people using this medication do not||
0736|078|S|have serious side effects.||
0736|079|S|   Tell your doctor right away if you have any serious side||
0736|080|S|effects, including: dizziness, eye pain/swelling/discharge,||
0736|081|S|swelling/redness of the eyelids, vision changes, slow/irregular||
0736|082|S|heartbeat, muscle weakness, unusual tiredness/weakness,||
0736|083|S|mental/mood changes (such as anxiety, depression),||
0736|084|S|coldness/numbness/pain in the hands or feet.||
0736|085|S|   Get medical help right away if you have any very serious side||
0736|086|S|effects, including: dizziness that doesn't stop, trouble||
0736|087|S|breathing, sudden unexplained weight gain, chest pain, weakness||
0736|088|S|on one side of the body, trouble speaking, confusion, fainting.||
0736|089|S|   A very serious allergic reaction to this drug is rare.||
0736|090|S|However, get medical help right away if you notice any symptoms||
0736|091|S|of a serious allergic reaction, including: rash, itching/swelling||
0736|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0736|093|S|breathing.||
0736|094|S|   This is not a complete list of possible side effects. If you||
0736|095|S|notice other effects not listed above, contact your doctor or||
0736|096|S|pharmacist.||
0736|097|S|   In the US -||
0736|098|S|   Call your doctor for medical advice about side effects. You||
0736|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0736|100|S|www.fda.gov/medwatch.||
0736|101|S|   In Canada - Call your doctor for medical advice about side||
0736|102|S|effects. You may report side effects to Health Canada at||
0736|103|S|1-866-234-2345.||
0736|104|B|||
0736|105|P|PRECAUTIONS:  Before using travoprost/timolol, tell your doctor||
0736|106|P|or pharmacist if you are allergic to it; or to similar drugs||
0736|107|P|(including beta-blockers such as betaxolol, levobunolol, or other||
0736|108|P|prostaglandin-like drugs such as bimatoprost, latanoprost), or if||
0736|109|P|you have any other allergies. This product may contain inactive||
0736|110|P|ingredients (such as preservatives like benzalkonium chloride),||
0736|111|P|which can cause allergic reactions or other problems. Talk to||
0736|112|P|your pharmacist for more details.||
0736|113|P|   Before using this medication, tell your doctor or pharmacist||
0736|114|P|your medical history, especially of: lung disease (such as||
0736|115|P|current or past history of asthma, severe chronic obstructive||
0736|116|P|pulmonary disease-COPD), certain types of irregular heartbeats||
0736|117|P|(such as sinus bradycardia, second- or third-degree AV block),||
0736|118|P|certain types of heart disease (such as severe heart failure,||
0736|119|P|cardiogenic shock), other eye problems (such as macular edema,||
0736|120|P|iritis, uveitis, lens extraction/aphakia), kidney disease, liver||
0736|121|P|disease, diabetes, low blood flow to the brain (cerebrovascular||
0736|122|P|insufficiency), overactive thyroid (hyperthyroidism), muscle||
0736|123|P|weakness disorders (such as myasthenia gravis), severe allergies.||
0736|124|P|   If you develop an eye infection or injury, or have eye||
0736|125|P|surgery, check with your doctor about whether you should continue||
0736|126|P|to use your current bottle of travoprost/timolol. Your doctor may||
0736|127|P|direct you to start using a new bottle.||
0736|128|P|   Before having surgery, tell your doctor or dentist about all||
0736|129|P|the products you use (including prescription drugs,||
0736|130|P|nonprescription drugs, and herbal products).||
0736|131|P|   This product may prevent the fast/pounding heartbeat you would||
0736|132|P|usually feel when your blood sugar level falls too low||
0736|133|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0736|134|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0736|135|P|blood sugar level, such as dizziness and sweating, are not||
0736|136|P|affected by this drug.||
0736|137|P|   If you have diabetes, this product may make it harder to||
0736|138|P|control your blood sugar levels. Check your blood sugar levels||
0736|139|P|regularly as directed by your doctor. Tell your doctor right away||
0736|140|P|if you have symptoms of high blood sugar such as increased||
0736|141|P|thirst/urination. Your doctor may need to adjust your diabetes||
0736|142|P|medication, exercise program, or diet.||
0736|143|P|   After you apply this drug, your vision may become temporarily||
0736|144|P|blurred. Do not drive, use machinery, or do anything that needs||
0736|145|P|clear vision until you can do it safely.||
0736|146|P|   During pregnancy, this medication should be used only when||
0736|147|P|clearly needed. Discuss the risks and benefits with your doctor.||
0736|148|P|   Timolol passes into breast milk. It is unknown if travoprost||
0736|149|P|passes into breast milk. Consult your doctor before||
0736|150|P|breastfeeding.||
0736|151|B|||
0736|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0736|153|I|medications work or increase your risk for serious side effects.||
0736|154|I|This document does not contain all possible drug interactions.||
0736|155|I|Keep a list of all the products you use (including||
0736|156|I|prescription/nonprescription drugs and herbal products) and share||
0736|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
0736|158|I|the dosage of any medicines without your doctor's approval.||
0736|159|I|   Some products that may interact with this drug include:||
0736|160|I|beta-blockers taken by mouth (such as propranolol), clonidine,||
0736|161|I|certain antidepressants (including SSRIs such as fluoxetine),||
0736|162|I|digoxin, epinephrine, eyelash treatment (such as topically||
0736|163|I|applied bimatoprost), methyldopa, prazosin, quinidine.||
0736|164|B|||
0736|165|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0736|166|O|has overdosed and has serious symptoms such as passing out or||
0736|167|O|trouble breathing, call 911. Otherwise, call a poison control||
0736|168|O|center right away. US residents can call 1-800-222-1222. Canada||
0736|169|O|residents can call 1-844-764-7669. If accidentally swallowed, you||
0736|170|O|may experience symptoms such as trouble breathing, slow/irregular||
0736|171|O|heartbeat, chest pain.||
0736|172|B|||
0736|173|N|NOTES:  Do not share this medication with others.||
0736|174|N|   Lab and/or medical tests (such as eye exams) may be done while||
0736|175|N|you are using this medication. Keep all medical and lab||
0736|176|N|appointments. Consult your doctor for more details.||
0736|177|B|||
0736|178|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0736|179|D|If it is near the time of the next dose, skip the missed dose.||
0736|180|D|Use your next dose at the regular time. Do not double the dose to||
0736|181|D|catch up.||
0736|182|B|||
0736|183|R|STORAGE:  Store in the refrigerator or at room temperature. Keep||
0736|184|R|all medications away from children and pets.||
0736|185|R|   Do not flush medications down the toilet or pour them into a||
0736|186|R|drain unless instructed to do so. Properly discard this product||
0736|187|R|when it is expired or no longer needed. Consult your pharmacist||
0736|188|R|or local waste disposal company.||
0736|189|B|||
0736|190|A|Information last revised May 2024.||
0736|191|A|Copyright(c) 2025 First Databank, Inc.||
0736|192|B|||
0738|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0738|002|Z|does NOT have all possible information about this product. This||
0738|003|Z|information does not assure that this product is safe, effective,||
0738|004|Z|or appropriate for you. This information is not individual||
0738|005|Z|medical advice and does not substitute for the advice of your||
0738|006|Z|health care professional. Always ask your health care||
0738|007|Z|professional for complete information about this product and your||
0738|008|Z|specific health needs.||
0738|009|B|||
0738|010|T|MECLOFENAMATE - ORAL||
0738|011|F|(me-KLOE-fen-am-ate SO-dee-um)||
0738|012|B|||
0738|013|C|COMMON BRAND NAME(S): Meclomen||
0738|014|B|||
0738|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0738|016|W|meclofenamate) may rarely increase the risk of a heart attack or||
0738|017|W|stroke. This effect can happen at any time while taking this drug||
0738|018|W|but is more likely if you take it for a long time. The risk may||
0738|019|W|be greater in older adults or if you have heart disease or||
0738|020|W|increased risk for heart disease (for example, due to smoking,||
0738|021|W|family history of heart disease, or conditions such as high blood||
0738|022|W|pressure or diabetes). Do not take this drug right before or||
0738|023|W|after heart bypass surgery (CABG).||
0738|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0738|025|W|bleeding from the stomach or intestines. This effect can occur||
0738|026|W|without warning symptoms at any time while taking this drug.||
0738|027|W|Older adults may be at higher risk for this effect.||
0738|028|W|   Stop taking meclofenamate and get medical help right away if||
0738|029|W|you notice any of these rare but serious side effects:||
0738|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0738|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0738|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0738|033|W|side of the body, trouble speaking, sudden vision changes.||
0738|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0738|035|W|of taking this drug.||
0738|036|B|||
0738|037|U|USES:  See also Warning section.||
0738|038|U|   Meclofenamate is used to relieve pain from various conditions||
0738|039|U|(such as headache, dental pain, muscle aches, and gout attacks)||
0738|040|U|and to decrease pain and blood loss from menstrual periods. It is||
0738|041|U|also used to reduce fever and to relieve minor aches and pain due||
0738|042|U|to the common cold or flu.||
0738|043|U|   Meclofenamate is also used to reduce pain, swelling, and joint||
0738|044|U|stiffness from arthritis.||
0738|045|U|   Meclofenamate is known as a nonsteroidal anti-inflammatory||
0738|046|U|drug (NSAID). It works by blocking your body's production of||
0738|047|U|certain natural substances that cause inflammation. This effect||
0738|048|U|helps to decrease swelling, pain, or fever.||
0738|049|U|   If you are treating a chronic condition such as arthritis, ask||
0738|050|U|your doctor about non-drug treatments and/or using other||
0738|051|U|medications to treat your pain.||
0738|052|B|||
0738|053|H|HOW TO USE:  Read the Medication Guide provided by your||
0738|054|H|pharmacist before you start taking meclofenamate and each time||
0738|055|H|you get a refill. If you have any questions, ask your doctor or||
0738|056|H|pharmacist.||
0738|057|H|   Take this medication by mouth as directed by your doctor,||
0738|058|H|usually 3 to 4 times a day or as needed. Take this medication||
0738|059|H|with a full glass of water (8 ounces or 240 milliliters) unless||
0738|060|H|your doctor directs you otherwise. Do not lie down for at least||
0738|061|H|10 minutes after taking this medication. If stomach upset occurs||
0738|062|H|while taking this medication, take it with food, milk, or an||
0738|063|H|antacid.||
0738|064|H|   The dosage and length of treatment are based on your medical||
0738|065|H|condition and response to treatment. To reduce your risk of||
0738|066|H|stomach bleeding and other side effects, take this medication at||
0738|067|H|the lowest effective dose for the shortest possible time. Do not||
0738|068|H|increase your dose or use this drug more often or for longer than||
0738|069|H|prescribed. For ongoing conditions such as arthritis, keep taking||
0738|070|H|this medication as directed. Discuss the risks and benefits with||
0738|071|H|your doctor or pharmacist.||
0738|072|H|   For certain conditions (such as arthritis), it may take up to||
0738|073|H|3 weeks of taking this drug regularly until you get the full||
0738|074|H|benefit.||
0738|075|H|   If you are taking this drug "as needed" (not on a regular||
0738|076|H|schedule), remember that pain medications work best if they are||
0738|077|H|used as the first signs of pain occur. If you wait until the pain||
0738|078|H|has worsened, the medicine may not work as well.||
0738|079|H|   Tell your doctor if your condition gets worse.||
0738|080|B|||
0738|081|S|SIDE EFFECTS:  See also Warning section.||
0738|082|S|   Upset stomach, diarrhea, nausea, vomiting, gas, heartburn,||
0738|083|S|dizziness, drowsiness, or headache may occur. If any of these||
0738|084|S|effects last or get worse, tell your doctor or pharmacist||
0738|085|S|promptly.||
0738|086|S|   Remember that this medication has been prescribed because your||
0738|087|S|doctor has judged that the benefit to you is greater than the||
0738|088|S|risk of side effects. Many people using this medication do not||
0738|089|S|have serious side effects.||
0738|090|S|   This medication may raise your blood pressure. Check your||
0738|091|S|blood pressure regularly and tell your doctor if the results are||
0738|092|S|high.||
0738|093|S|   Tell your doctor right away if you have any serious side||
0738|094|S|effects, including: hearing changes (such as ringing in the||
0738|095|S|ears), mental/mood changes, easy bleeding/bruising,||
0738|096|S|difficult/painful swallowing, signs of kidney problems (such as||
0738|097|S|change in the amount of urine, pink/bloody urine), symptoms of||
0738|098|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
0738|099|S|unusual/sudden weight gain).||
0738|100|S|   Meclofenamate may rarely cause serious (possibly fatal) liver||
0738|101|S|disease. Get medical help right away if you have any symptoms of||
0738|102|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0738|103|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0738|104|S|urine.||
0738|105|S|   A very serious allergic reaction to this drug is rare.||
0738|106|S|However, get medical help right away if you notice any symptoms||
0738|107|S|of a serious allergic reaction, including: fever, swollen lymph||
0738|108|S|nodes, rash, itching/swelling (especially of the||
0738|109|S|face/tongue/throat), severe dizziness, trouble breathing.||
0738|110|S|   This is not a complete list of possible side effects. If you||
0738|111|S|notice other effects not listed above, contact your doctor or||
0738|112|S|pharmacist.||
0738|113|S|   In the US -||
0738|114|S|   Call your doctor for medical advice about side effects. You||
0738|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0738|116|S|www.fda.gov/medwatch.||
0738|117|S|   In Canada - Call your doctor for medical advice about side||
0738|118|S|effects. You may report side effects to Health Canada at||
0738|119|S|1-866-234-2345.||
0738|120|B|||
0738|121|P|PRECAUTIONS:  See also Warning section.||
0738|122|P|   Before taking meclofenamate, tell your doctor or pharmacist if||
0738|123|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
0738|124|P|ibuprofen, naproxen, celecoxib); or if you have any other||
0738|125|P|allergies. This product may contain inactive ingredients, which||
0738|126|P|can cause allergic reactions or other problems. Talk to your||
0738|127|P|pharmacist for more details.||
0738|128|P|   Before using this medication, tell your doctor or pharmacist||
0738|129|P|your medical history, especially of: asthma (including a history||
0738|130|P|of worsening breathing after taking aspirin or other NSAIDs),||
0738|131|P|bleeding/clotting problems, blood disorders (such as anemia),||
0738|132|P|growths in the nose (nasal polyps), heart disease (such as||
0738|133|P|previous heart attack), high blood pressure, liver disease,||
0738|134|P|stroke, swelling (edema, fluid retention),||
0738|135|P|stomach/intestinal/esophagus problems (such as bleeding,||
0738|136|P|heartburn, ulcers).||
0738|137|P|   Kidney problems can sometimes occur with the use of NSAID||
0738|138|P|medications, including meclofenamate. Problems are more likely to||
0738|139|P|occur if you are dehydrated, have heart failure or kidney||
0738|140|P|disease, are an older adult, or if you take certain medications||
0738|141|P|(see also Drug Interactions section). Drink plenty of fluids as||
0738|142|P|directed by your doctor to prevent dehydration and tell your||
0738|143|P|doctor right away if you have pink/bloody urine or any unusual||
0738|144|P|change in the amount of urine.||
0738|145|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0738|146|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0738|147|P|machinery, or do anything that needs alertness until you can do||
0738|148|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0738|149|P|are using marijuana (cannabis).||
0738|150|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0738|151|P|and tobacco, especially when combined with this medicine, may||
0738|152|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0738|153|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
0738|154|P|may safely drink.||
0738|155|P|   Before having surgery, tell your doctor or dentist about all||
0738|156|P|the products you use (including prescription drugs,||
0738|157|P|nonprescription drugs, and herbal products).||
0738|158|P|   Older adults may be at greater risk for stomach/intestinal||
0738|159|P|bleeding, kidney problems, heart attack, and stroke while using||
0738|160|P|this drug.||
0738|161|P|   Before using this medication, women of childbearing age should||
0738|162|P|talk with their doctor(s) about the benefits and risks. Tell your||
0738|163|P|doctor if you are pregnant or if you plan to become pregnant.||
0738|164|P|This medication may harm an unborn baby and cause problems with||
0738|165|P|normal labor/delivery. It is not recommended for use in pregnancy||
0738|166|P|from 20 weeks until delivery. If your doctor decides that you||
0738|167|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0738|168|P|you should use the lowest effective dose for the shortest||
0738|169|P|possible time. You should not use this medication after 30 weeks||
0738|170|P|of pregnancy.||
0738|171|P|   This medication passes into breast milk. Consult your doctor||
0738|172|P|before breastfeeding.||
0738|173|B|||
0738|174|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0738|175|I|medications work or increase your risk for serious side effects.||
0738|176|I|This document does not contain all possible drug interactions.||
0738|177|I|Keep a list of all the products you use (including||
0738|178|I|prescription/nonprescription drugs and herbal products) and share||
0738|179|I|it with your doctor and pharmacist. Do not start, stop, or change||
0738|180|I|the dosage of any medicines without your doctor's approval.||
0738|181|I|   Some products that may interact with this drug are: aliskiren,||
0738|182|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
0738|183|I|receptor blockers (such as losartan, valsartan), cidofovir,||
0738|184|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
0738|185|I|methotrexate, "water pills" (diuretics such as furosemide).||
0738|186|I|   This medication may increase the risk of bleeding when taken||
0738|187|I|with other drugs that also may cause bleeding. Examples include||
0738|188|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0738|189|I|dabigatran/enoxaparin/warfarin, among others.||
0738|190|I|   Check all prescription and nonprescription medicine labels||
0738|191|I|carefully since many medications contain pain relievers/fever||
0738|192|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
0738|193|I|naproxen). These drugs are similar to meclofenamate and may||
0738|194|I|increase your risk of side effects if taken together. However, if||
0738|195|I|your doctor has told you to take low-dose aspirin to prevent||
0738|196|I|heart attack or stroke (usually 81-162 milligrams a day), you||
0738|197|I|should keep taking the aspirin unless your doctor tells you not||
0738|198|I|to. Ask your doctor or pharmacist for more details.||
0738|199|B|||
0738|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0738|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0738|202|O|poison control center right away. US residents can call||
0738|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0738|204|O|Symptoms of overdose may include: severe stomach pain,||
0738|205|O|slow/shallow breathing, seizures.||
0738|206|B|||
0738|207|N|NOTES:  Do not share this medication with others.||
0738|208|N|   Lab and/or medical tests (such as complete blood count, liver||
0738|209|N|and kidney function, blood pressure, eye exams) may be done while||
0738|210|N|you are using this medication. Keep all medical and lab||
0738|211|N|appointments. Consult your doctor for more details.||
0738|212|N|   Lifestyle changes (such as weight loss if needed,||
0738|213|N|strengthening/conditioning exercises) may help improve your||
0738|214|N|flexibility and joint function. Consult your doctor for specific||
0738|215|N|instructions.||
0738|216|B|||
0738|217|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
0738|218|D|(not just "as needed") and you miss a dose, take it as soon as||
0738|219|D|you remember. If it is near the time of the next dose, skip the||
0738|220|D|missed dose. Take your next dose at the regular time. Do not||
0738|221|D|double the dose to catch up.||
0738|222|B|||
0738|223|R|STORAGE:  Store at room temperature away from light and moisture.||
0738|224|R|Do not store in the bathroom. Keep all medications away from||
0738|225|R|children and pets.||
0738|226|R|   Do not flush medications down the toilet or pour them into a||
0738|227|R|drain unless instructed to do so. Properly discard this product||
0738|228|R|when it is expired or no longer needed. Consult your pharmacist||
0738|229|R|or local waste disposal company.||
0738|230|B|||
0738|231|A|Information last revised November 2025.||
0738|232|A|Copyright(c) 2025 First Databank, Inc.||
0738|233|B|||
0739|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0739|002|Z|does NOT have all possible information about this product. This||
0739|003|Z|information does not assure that this product is safe, effective,||
0739|004|Z|or appropriate for you. This information is not individual||
0739|005|Z|medical advice and does not substitute for the advice of your||
0739|006|Z|health care professional. Always ask your health care||
0739|007|Z|professional for complete information about this product and your||
0739|008|Z|specific health needs.||
0739|009|B|||
0739|010|T|TOLMETIN SODIUM - ORAL||
0739|011|F|(tole-MET-in SO-dee-um)||
0739|012|B|||
0739|013|C|COMMON BRAND NAME(S): Tolectin||
0739|014|B|||
0739|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0739|016|W|tolmetin) may rarely increase the risk for a heart attack or||
0739|017|W|stroke. This effect can happen at any time while taking this drug||
0739|018|W|but is more likely if you take it for a long time. The risk may||
0739|019|W|be greater in older adults or if you have heart disease or||
0739|020|W|increased risk for heart disease (for example, due to smoking,||
0739|021|W|family history of heart disease, or conditions such as high blood||
0739|022|W|pressure or diabetes). Do not take this drug right before or||
0739|023|W|after heart bypass surgery (CABG).||
0739|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
0739|025|W|bleeding from the stomach or intestines. This effect can occur||
0739|026|W|without warning symptoms at any time while taking this drug.||
0739|027|W|Older adults may be at higher risk for this effect.||
0739|028|W|   Stop taking this medication and get medical help right away if||
0739|029|W|you notice any of these rare but serious side effects:||
0739|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0739|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0739|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0739|033|W|side of the body, trouble speaking, sudden vision changes.||
0739|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0739|035|W|of taking this drug.||
0739|036|B|||
0739|037|U|USES:  Tolmetin is used alone or with other treatments to reduce||
0739|038|U|pain, swelling, and joint stiffness from rheumatoid arthritis and||
0739|039|U|osteoarthritis. It is also used for juvenile rheumatoid||
0739|040|U|arthritis.||
0739|041|U|   If you are treating a chronic condition such as arthritis, ask||
0739|042|U|your doctor about non-drug treatments and/or using other||
0739|043|U|medications to treat your pain. See also Warning section.||
0739|044|U|   Tolmetin is known as a nonsteroidal anti-inflammatory drug||
0739|045|U|(NSAID).||
0739|046|B|||
0739|047|V|OTHER USES:  This section contains uses of this drug that are not||
0739|048|V|listed in the approved professional labeling for the drug but||
0739|049|V|that may be prescribed by your health care professional. Use this||
0739|050|V|drug for a condition that is listed in this section only if it||
0739|051|V|has been so prescribed by your health care professional.||
0739|052|V|   This drug may also be used for arthritis of the spine or gout||
0739|053|V|attacks.||
0739|054|B|||
0739|055|H|HOW TO USE:  Read the Medication Guide provided by your||
0739|056|H|pharmacist before you start using tolmetin and each time you get||
0739|057|H|a refill. If you have any questions, consult your doctor or||
0739|058|H|pharmacist.||
0739|059|H|   Take this medication by mouth as directed by your doctor,||
0739|060|H|usually 3 times a day with a full glass of water (8 ounces or 240||
0739|061|H|milliliters). Do not lie down for at least 10 minutes after||
0739|062|H|taking this drug. If stomach upset occurs, take this medication||
0739|063|H|with food, milk, or an antacid (except sodium bicarbonate).||
0739|064|H|   The dosage is based on your medical condition and response to||
0739|065|H|treatment. Children's dosage is also based on weight. To reduce||
0739|066|H|your risk of stomach bleeding and other side effects, take this||
0739|067|H|medication at the lowest effective dose for the shortest possible||
0739|068|H|time. Do not increase your dose, take it more often, or take it||
0739|069|H|for a longer time than prescribed. Discuss the risks and benefits||
0739|070|H|with your doctor or pharmacist.||
0739|071|H|   Take this medication regularly in order to get the most||
0739|072|H|benefit from it. To help you remember, take it at the same times||
0739|073|H|each day. It may take 1 to 2 weeks of taking this drug regularly||
0739|074|H|until you get the full benefit.||
0739|075|H|   Tell your doctor if your condition gets worse or if you||
0739|076|H|develop new symptoms.||
0739|077|B|||
0739|078|S|SIDE EFFECTS:  See also Warning section.||
0739|079|S|   Nausea, vomiting, heartburn, dizziness, drowsiness, diarrhea,||
0739|080|S|and headache may occur. If any of these effects last or get||
0739|081|S|worse, tell your doctor or pharmacist promptly.||
0739|082|S|   Remember that this medication has been prescribed because your||
0739|083|S|doctor has judged that the benefit to you is greater than the||
0739|084|S|risk of side effects. Many people using this medication do not||
0739|085|S|have serious side effects.||
0739|086|S|   This medication may raise your blood pressure. Check your||
0739|087|S|blood pressure regularly and tell your doctor if the results are||
0739|088|S|high.||
0739|089|S|   Tell your doctor right away if you have any serious side||
0739|090|S|effects, including: fainting, fast/pounding heartbeat, hearing||
0739|091|S|changes (such as ringing in the ears), mental/mood changes,||
0739|092|S|difficult/painful swallowing, easy bruising/bleeding, signs of||
0739|093|S|kidney problems (such as change in the amount of urine), vision||
0739|094|S|changes, symptoms of heart failure (such as swelling ankles/feet,||
0739|095|S|unusual tiredness, unusual/sudden weight gain).||
0739|096|S|   This drug may rarely cause serious (possibly fatal) liver||
0739|097|S|disease. Get medical help right away if you have any symptoms of||
0739|098|S|liver damage, including: nausea/vomiting that doesn't stop,||
0739|099|S|stomach/abdominal pain, loss of appetite, dark urine, yellowing||
0739|100|S|eyes/skin.||
0739|101|S|   A very serious allergic reaction to this drug is rare.||
0739|102|S|However, get medical help right away if you notice any symptoms||
0739|103|S|of a serious allergic reaction, including: fever, swollen lymph||
0739|104|S|nodes, rash, itching/swelling (especially of the||
0739|105|S|face/tongue/throat), severe dizziness, trouble breathing.||
0739|106|S|   This is not a complete list of possible side effects. If you||
0739|107|S|notice other effects not listed above, contact your doctor or||
0739|108|S|pharmacist.||
0739|109|S|   In the US -||
0739|110|S|   Call your doctor for medical advice about side effects. You||
0739|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0739|112|S|www.fda.gov/medwatch.||
0739|113|S|   In Canada - Call your doctor for medical advice about side||
0739|114|S|effects. You may report side effects to Health Canada at||
0739|115|S|1-866-234-2345.||
0739|116|B|||
0739|117|P|PRECAUTIONS:  Before taking tolmetin, tell your doctor or||
0739|118|P|pharmacist if you are allergic to it; or to aspirin or other||
0739|119|P|NSAIDs (such as ibuprofen, naproxen, zomepirac, celecoxib); or if||
0739|120|P|you have any other allergies. This product may contain inactive||
0739|121|P|ingredients, which can cause allergic reactions or other||
0739|122|P|problems. Talk to your pharmacist for more details.||
0739|123|P|   Before using this medication, tell your doctor or pharmacist||
0739|124|P|your medical history, especially of: asthma (including a history||
0739|125|P|of worsening breathing after taking aspirin or other NSAIDs),||
0739|126|P|bleeding/clotting problems, blood disorders (such as anemia),||
0739|127|P|high blood pressure, diabetes, heart disease (such as history of||
0739|128|P|heart attack), liver disease, growths in the nose (nasal polyps),||
0739|129|P|obesity, tobacco use, stomach/intestine/esophagus problems||
0739|130|P|(bleeding sores/ulcer, gastrointestinal bleeding, reflux||
0739|131|P|disease), stroke, swelling of the ankles/feet/hands.||
0739|132|P|   Kidney problems can sometimes occur with the use of NSAID||
0739|133|P|medications, including tolmetin. Problems are more likely to||
0739|134|P|occur if you are dehydrated, have heart failure or kidney||
0739|135|P|disease, are an older adult, or if you take certain medications||
0739|136|P|(see also Drug Interactions section). Drink plenty of fluids as||
0739|137|P|directed by your doctor to prevent dehydration and tell your||
0739|138|P|doctor right away if you have a change in the amount of urine.||
0739|139|P|   Before having surgery, tell your doctor or dentist about all||
0739|140|P|the products you use (including prescription drugs,||
0739|141|P|nonprescription drugs, and herbal products).||
0739|142|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0739|143|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0739|144|P|machinery, or do anything that needs alertness until you can do||
0739|145|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0739|146|P|are using marijuana (cannabis).||
0739|147|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0739|148|P|and tobacco, especially when combined with this medicine, may||
0739|149|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0739|150|P|smoking. Consult your doctor or pharmacist for more information.||
0739|151|P|   This medicine contains sodium. If you are on a salt-restricted||
0739|152|P|diet or have any condition that requires you to restrict your||
0739|153|P|intake of salt, consult your doctor or pharmacist about using||
0739|154|P|this drug safely.||
0739|155|P|   Older adults may be at greater risk for stomach/intestinal||
0739|156|P|bleeding, kidney problems, heart attack, and stroke while using||
0739|157|P|this drug.||
0739|158|P|   Before using this medication, women of childbearing age should||
0739|159|P|talk with their doctor(s) about the benefits and risks. Tell your||
0739|160|P|doctor if you are pregnant or if you plan to become pregnant.||
0739|161|P|This medication may harm an unborn baby and cause problems with||
0739|162|P|normal labor/delivery. It is not recommended for use in pregnancy||
0739|163|P|from 20 weeks until delivery. If your doctor decides that you||
0739|164|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0739|165|P|you should use the lowest effective dose for the shortest||
0739|166|P|possible time. You should not use this medication after 30 weeks||
0739|167|P|of pregnancy.||
0739|168|P|   This drug passes into breast milk. Consult your doctor before||
0739|169|P|breastfeeding.||
0739|170|B|||
0739|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0739|172|I|medications work or increase your risk for serious side effects.||
0739|173|I|This document does not contain all possible drug interactions.||
0739|174|I|Keep a list of all the products you use (including||
0739|175|I|prescription/nonprescription drugs and herbal products) and share||
0739|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
0739|177|I|the dosage of any medicines without your doctor's approval.||
0739|178|I|   Some products that may interact with this drug include:||
0739|179|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
0739|180|I|angiotensin II receptor blockers (such as losartan, valsartan),||
0739|181|I|cidofovir, corticosteroids (such as prednisone), lithium,||
0739|182|I|methotrexate, "water pills" (diuretics such as furosemide).||
0739|183|I|   This medication may increase the risk of bleeding when taken||
0739|184|I|with other drugs that also may cause bleeding. Examples include||
0739|185|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0739|186|I|dabigatran/enoxaparin/warfarin, among others.||
0739|187|I|   Check all prescription and nonprescription medicine labels||
0739|188|I|carefully since many medications contain pain relievers/fever||
0739|189|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
0739|190|I|ketorolac). These drugs are similar to tolmetin and may increase||
0739|191|I|your risk of side effects if taken together. However, if your||
0739|192|I|doctor has told you to take low-dose aspirin to prevent heart||
0739|193|I|attack or stroke (usually 81-162 milligrams a day), you should||
0739|194|I|keep taking the aspirin unless your doctor tells you not to. Ask||
0739|195|I|your doctor or pharmacist for more details.||
0739|196|I|   This medication may interfere with certain lab tests (such as||
0739|197|I|protein in urine), possibly causing false test results. Make sure||
0739|198|I|lab personnel and all your doctors know you use this drug.||
0739|199|B|||
0739|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0739|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0739|202|O|poison control center right away. US residents can call||
0739|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0739|204|O|Symptoms of overdose may include: severe stomach pain, vomit that||
0739|205|O|looks like coffee grounds, extreme drowsiness, slow/shallow||
0739|206|O|breathing, seizures.||
0739|207|B|||
0739|208|N|NOTES:  Do not share this drug with others.||
0739|209|N|   Lab and/or medical tests (such as blood pressure, complete||
0739|210|N|blood count, eye exams, liver/kidney function) may be done while||
0739|211|N|you are taking this medication. Keep all medical and lab||
0739|212|N|appointments. Consult your doctor for more details.||
0739|213|B|||
0739|214|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0739|215|D|remember. If it is near the time of the next dose, skip the||
0739|216|D|missed dose. Take your next dose at the regular time. Do not||
0739|217|D|double the dose to catch up.||
0739|218|B|||
0739|219|R|STORAGE:  Store at room temperature away from light and moisture.||
0739|220|R|Do not store in the bathroom. Keep all medications away from||
0739|221|R|children and pets.||
0739|222|R|   Do not flush medications down the toilet or pour them into a||
0739|223|R|drain unless instructed to do so. Properly discard this product||
0739|224|R|when it is expired or no longer needed. Consult your pharmacist||
0739|225|R|or local waste disposal company.||
0739|226|B|||
0739|227|A|Information last revised November 2024.||
0739|228|A|Copyright(c) 2025 First Databank, Inc.||
0739|229|B|||
0740|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0740|002|Z|does NOT have all possible information about this product. This||
0740|003|Z|information does not assure that this product is safe, effective,||
0740|004|Z|or appropriate for you. This information is not individual||
0740|005|Z|medical advice and does not substitute for the advice of your||
0740|006|Z|health care professional. Always ask your health care||
0740|007|Z|professional for complete information about this product and your||
0740|008|Z|specific health needs.||
0740|009|B|||
0740|010|T|PHENTERMINE - ORAL||
0740|011|F|(FEN-ter-meen)||
0740|012|B|||
0740|013|C|COMMON BRAND NAME(S): Adipex-P, Ionamin, Pro-Fast||
0740|014|B|||
0740|015|U|USES:  Phentermine is used with a doctor-approved exercise,||
0740|016|U|behavior change, and reduced-calorie diet program to help you||
0740|017|U|lose weight. It is used by certain overweight people, such as||
0740|018|U|those who are obese or have weight-related medical problems.||
0740|019|U|Losing weight and keeping it off can lessen the many health risks||
0740|020|U|that come with obesity, including heart disease, diabetes, high||
0740|021|U|blood pressure, and a shorter life.||
0740|022|U|   It is not known how this medication helps people to lose||
0740|023|U|weight. It may work by decreasing your appetite, increasing the||
0740|024|U|amount of energy used by your body, or by affecting certain parts||
0740|025|U|of the brain. This medication is an appetite suppressant and||
0740|026|U|belongs to a class of drugs called sympathomimetic amines.||
0740|027|B|||
0740|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
0740|029|H|doctor, usually once a day, 1 hour before breakfast or 1 to 2||
0740|030|H|hours after breakfast. If needed, your doctor may adjust your||
0740|031|H|dose to take a small dose up to 3 times a day. Carefully follow||
0740|032|H|your doctor's instructions. Taking this medication late in the||
0740|033|H|day may cause trouble sleeping (insomnia).||
0740|034|H|   If you are using sustained-release capsules, the dose is||
0740|035|H|usually taken once a day before breakfast or at least 10 to 14||
0740|036|H|hours before bedtime. Swallow the medication whole. Do not crush||
0740|037|H|or chew sustained-release capsules. Doing so can release all of||
0740|038|H|the drug at once, increasing the risk of side effects.||
0740|039|H|   If you are using the tablets made to dissolve in the mouth,||
0740|040|H|the dose is usually taken once a day in the morning, with or||
0740|041|H|without food. First, dry your hands before handling the tablet.||
0740|042|H|Place your dose on top of the tongue until it dissolves, then||
0740|043|H|swallow it with or without water.||
0740|044|H|   The dosage and length of treatment are based on your medical||
0740|045|H|condition and response to treatment. Your doctor will adjust the||
0740|046|H|dose to find the best dose for you. Discuss the risks and||
0740|047|H|benefits, and the length of phentermine treatment, with your||
0740|048|H|doctor. To get the most benefit, take this medication regularly,||
0740|049|H|exactly as prescribed, and for as long as directed by your||
0740|050|H|doctor. To help you remember, take it at the same time(s) each||
0740|051|H|day.||
0740|052|H|   Caffeine can increase the side effects of this medication.||
0740|053|H|Avoid drinking large amounts of beverages containing caffeine||
0740|054|H|(coffee, tea, colas), eating large amounts of chocolate, or||
0740|055|H|taking nonprescription products that contain caffeine.||
0740|056|H|   If you suddenly stop using this medication, you may have||
0740|057|H|withdrawal symptoms (such as depression, severe tiredness). To||
0740|058|H|help prevent withdrawal, your doctor may lower your dose slowly.||
0740|059|H|Withdrawal is more likely if you have used phentermine for a long||
0740|060|H|time or in high doses. Tell your doctor or pharmacist right away||
0740|061|H|if you have withdrawal.||
0740|062|H|   Though it helps many people, this medication may sometimes||
0740|063|H|cause addiction. This risk may be higher if you have a substance||
0740|064|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0740|065|H|Do not increase your dose, take it more often, or use it for a||
0740|066|H|longer time than prescribed. Properly stop the medication when so||
0740|067|H|directed.||
0740|068|H|   This medication may stop working well after you have been||
0740|069|H|taking it for a few weeks. Talk with your doctor if this||
0740|070|H|medication stops working well. Do not increase the dose unless||
0740|071|H|directed by your doctor. Your doctor may direct you to stop||
0740|072|H|taking this medication.||
0740|073|B|||
0740|074|S|SIDE EFFECTS:  Dizziness, dry mouth, difficulty sleeping,||
0740|075|S|irritability, nausea, vomiting, diarrhea, or constipation may||
0740|076|S|occur. If any of these effects last or get worse, tell your||
0740|077|S|doctor or pharmacist promptly.||
0740|078|S|   Remember that this medication has been prescribed because your||
0740|079|S|doctor has judged that the benefit to you is greater than the||
0740|080|S|risk of side effects. Many people using this medication do not||
0740|081|S|have serious side effects.||
0740|082|S|   This medication may raise your blood pressure. Check your||
0740|083|S|blood pressure regularly and tell your doctor if the results are||
0740|084|S|high.||
0740|085|S|   Tell your doctor right away if you have any serious side||
0740|086|S|effects, including: fast/irregular/pounding heartbeat,||
0740|087|S|mental/mood changes (such as agitation, uncontrolled anger,||
0740|088|S|hallucinations, nervousness), uncontrolled muscle movements,||
0740|089|S|change in sexual ability/interest.||
0740|090|S|   Stop taking this medication and get medical help right away if||
0740|091|S|you have any very serious side effects, including: severe||
0740|092|S|headache, trouble speaking, seizure, weakness on one side of the||
0740|093|S|body, vision changes (such as blurred vision).||
0740|094|S|   This drug may rarely cause serious (sometimes fatal) lung or||
0740|095|S|heart problems (pulmonary hypertension, heart valve problems).||
0740|096|S|The risk may increase with longer use of this medication and use||
0740|097|S|of this drug along with other appetite-suppressant drugs/herbal||
0740|098|S|products. Stop taking this medication and get medical help right||
0740|099|S|away if you have any very serious side effects, including: chest||
0740|100|S|pain, difficulty breathing with exercise, decreased ability to||
0740|101|S|exercise, fainting, swelling of the legs/ankles/feet.||
0740|102|S|   A very serious allergic reaction to this drug is rare.||
0740|103|S|However, get medical help right away if you notice any symptoms||
0740|104|S|of a serious allergic reaction, including: rash, itching/swelling||
0740|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0740|106|S|breathing.||
0740|107|S|   This is not a complete list of possible side effects. If you||
0740|108|S|notice other effects not listed above, contact your doctor or||
0740|109|S|pharmacist.||
0740|110|S|   In the US -||
0740|111|S|   Call your doctor for medical advice about side effects. You||
0740|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0740|113|S|www.fda.gov/medwatch.||
0740|114|S|   In Canada - Call your doctor for medical advice about side||
0740|115|S|effects. You may report side effects to Health Canada at||
0740|116|S|1-866-234-2345.||
0740|117|B|||
0740|118|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0740|119|P|pharmacist if you are allergic to it; or to any other||
0740|120|P|sympathomimetic amines (including decongestants such as||
0740|121|P|pseudoephedrine, stimulants such as amphetamine, appetite||
0740|122|P|suppressants such as diethylpropion); or if you have any other||
0740|123|P|allergies. This product may contain inactive ingredients, which||
0740|124|P|can cause allergic reactions or other problems. Talk to your||
0740|125|P|pharmacist for more details.||
0740|126|P|   Before using this medication, tell your doctor or pharmacist||
0740|127|P|your medical history, especially of: diabetes, high blood||
0740|128|P|pressure, glaucoma, personal or family history of a substance use||
0740|129|P|disorder (such as overuse of or addiction to drugs/alcohol),||
0740|130|P|heart disease (such as chest pain, heart attack, heart murmur,||
0740|131|P|fast/irregular heartbeat, heart valve problems), mental/mood||
0740|132|P|problems (such as depression, thoughts of suicide, severe||
0740|133|P|anxiety/agitation), high blood pressure in the lungs (pulmonary||
0740|134|P|hypertension), stroke, overactive thyroid (hyperthyroidism),||
0740|135|P|kidney disease, seizures.||
0740|136|P|   This drug may make you dizzy or blur your vision. It may also||
0740|137|P|rarely make you drowsy. Alcohol or marijuana (cannabis) can make||
0740|138|P|you more dizzy or drowsy. Do not drive, use machinery, or do||
0740|139|P|anything that needs alertness or clear vision until you can do it||
0740|140|P|safely. Avoid alcoholic beverages. Talk to your doctor if you are||
0740|141|P|using marijuana (cannabis).||
0740|142|P|   If you have diabetes, check your blood sugar regularly as||
0740|143|P|directed and share the results with your doctor. Your doctor may||
0740|144|P|need to adjust your diabetes medication during treatment with||
0740|145|P|this drug.||
0740|146|P|   If you are using the tablets made to dissolve in the mouth,||
0740|147|P|your medication may contain aspartame. If you have||
0740|148|P|phenylketonuria (PKU) or any other condition that requires you to||
0740|149|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
0740|150|P|doctor or pharmacist about using this medication safely.||
0740|151|P|   Before having surgery, tell your doctor or dentist about all||
0740|152|P|the products you use (including prescription drugs,||
0740|153|P|nonprescription drugs, and herbal products).||
0740|154|P|   Older adults may be at greater risk for dizziness and high||
0740|155|P|blood pressure while using this drug.||
0740|156|P|   This medication must not be used during pregnancy. It may harm||
0740|157|P|an unborn baby. If you are pregnant or think you may be pregnant,||
0740|158|P|tell your doctor right away.||
0740|159|P|   This drug may pass into breast milk and could have undesirable||
0740|160|P|effects on a nursing infant. Breastfeeding is not recommended||
0740|161|P|while using this drug. Consult your doctor before breastfeeding.||
0740|162|B|||
0740|163|I|DRUG INTERACTIONS:  See also How to Use section.||
0740|164|I|   Drug interactions may change how your medications work or||
0740|165|I|increase your risk for serious side effects. This document does||
0740|166|I|not contain all possible drug interactions. Keep a list of all||
0740|167|I|the products you use (including prescription/nonprescription||
0740|168|I|drugs and herbal products) and share it with your doctor and||
0740|169|I|pharmacist. Do not start, stop, or change the dosage of any||
0740|170|I|medicines without your doctor's approval.||
0740|171|I|   This drug should not be used with certain medications because||
0740|172|I|very serious interactions may occur. If you are taking or have||
0740|173|I|taken other appetite-suppressant drugs in the past year (such as||
0740|174|I|diethylpropion, ephedra/ma huang), tell your doctor or pharmacist||
0740|175|I|before starting this medication.||
0740|176|I|   Taking MAO inhibitors with this medication may cause a serious||
0740|177|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0740|178|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0740|179|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0740|180|I|selegiline, tranylcypromine) during treatment with this||
0740|181|I|medication. Most MAO inhibitors should also not be taken for two||
0740|182|I|weeks before treatment with this medication. Ask your doctor when||
0740|183|I|to start or stop taking this medication.||
0740|184|I|   Some products that may interact with this drug are: high blood||
0740|185|I|pressure medicine (such as guanethidine, methyldopa),||
0740|186|I|phenothiazines (such as prochlorperazine, chlorpromazine), other||
0740|187|I|stimulants (including amphetamines, methylphenidate, street drugs||
0740|188|I|such as cocaine or MDMA/"ecstasy").||
0740|189|I|   Tell your doctor or pharmacist if you are taking other||
0740|190|I|products that cause drowsiness such as opioid pain or cough||
0740|191|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0740|192|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0740|193|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0740|194|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0740|195|I|diphenhydramine).||
0740|196|I|   Check the labels on all your medicines (such as allergy or||
0740|197|I|cough-and-cold products) because they may contain ingredients||
0740|198|I|that cause drowsiness. Ask your pharmacist about using those||
0740|199|I|products safely.||
0740|200|I|   Some products have ingredients that could raise your heart||
0740|201|I|rate or blood pressure. Tell your pharmacist what products you||
0740|202|I|are using, and ask how to use them safely (especially||
0740|203|I|cough-and-cold products or diet aids).||
0740|204|I|   This medication may interfere with certain medical/lab tests||
0740|205|I|(such as brain scan for Parkinson's disease), possibly causing||
0740|206|I|false test results. Make sure lab personnel and all your doctors||
0740|207|I|know you use this drug.||
0740|208|B|||
0740|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0740|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0740|211|O|poison control center right away. US residents can call||
0740|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0740|213|O|Symptoms of overdose may include: rapid breathing, unusual||
0740|214|O|restlessness, fast/slow/irregular heartbeat, chest pain,||
0740|215|O|hallucinations, seizures, loss of consciousness.||
0740|216|B|||
0740|217|N|NOTES:  Appetite suppressants should not be used in place of||
0740|218|N|proper diet. For best results, this drug must be used along with||
0740|219|N|a doctor-approved diet and exercise program.||
0740|220|N|   Do not share this medication with others. Sharing it is||
0740|221|N|against the law.||
0740|222|N|   Lab and/or medical tests (such as blood pressure, heart tests,||
0740|223|N|kidney tests) should be done while you are taking this||
0740|224|N|medication. Keep all medical and lab appointments. Consult your||
0740|225|N|doctor for more details.||
0740|226|B|||
0740|227|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0740|228|D|remember. If it is near the time of the next dose or late in the||
0740|229|D|evening, skip the missed dose. Take your next dose at the regular||
0740|230|D|time. Do not double the dose to catch up.||
0740|231|B|||
0740|232|R|STORAGE:  Store at room temperature away from light and moisture.||
0740|233|R|Do not store in the bathroom. Keep all medications away from||
0740|234|R|children and pets.||
0740|235|R|   Do not flush medications down the toilet or pour them into a||
0740|236|R|drain unless instructed to do so. Properly discard this product||
0740|237|R|when it is expired or no longer needed. Consult your pharmacist||
0740|238|R|or local waste disposal company.||
0740|239|B|||
0740|240|A|Information last revised July 2025.||
0740|241|A|Copyright(c) 2025 First Databank, Inc.||
0740|242|B|||
0741|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0741|002|Z|does NOT have all possible information about this product. This||
0741|003|Z|information does not assure that this product is safe, effective,||
0741|004|Z|or appropriate for you. This information is not individual||
0741|005|Z|medical advice and does not substitute for the advice of your||
0741|006|Z|health care professional. Always ask your health care||
0741|007|Z|professional for complete information about this product and your||
0741|008|Z|specific health needs.||
0741|009|B|||
0741|010|T|PHENDIMETRAZINE - ORAL||
0741|011|F|(FEN-dye-meh-TRA-zeen)||
0741|012|B|||
0741|013|C|COMMON BRAND NAME(S): Bontril PDM, Plegine||
0741|014|B|||
0741|015|U|USES:  Phendimetrazine is used with a doctor-approved exercise,||
0741|016|U|behavior change, and reduced-calorie diet program to help you||
0741|017|U|lose weight. It is used by certain overweight people, such as||
0741|018|U|those who are obese or have weight-related medical problems.||
0741|019|U|Losing weight and keeping it off can lessen the many health risks||
0741|020|U|that come with obesity, including heart disease, diabetes, high||
0741|021|U|blood pressure, and a shorter life.||
0741|022|U|   It is not known how this medication helps people to lose||
0741|023|U|weight. It may work by decreasing your appetite, increasing the||
0741|024|U|amount of energy used by your body, or by affecting certain parts||
0741|025|U|of the brain. This medication is an appetite suppressant and||
0741|026|U|belongs to a class of drugs called sympathomimetic amines.||
0741|027|B|||
0741|028|H|HOW TO USE:  Take the immediate-release form of this medication||
0741|029|H|by mouth as directed by your doctor, usually 2 to 3 times a day||
0741|030|H|(1 hour before meals). Taking this medication late in the day may||
0741|031|H|cause trouble sleeping (insomnia).||
0741|032|H|   The sustained-release form of phendimetrazine is usually taken||
0741|033|H|once a day 30 - 60 minutes before the morning meal. Swallow this||
0741|034|H|medication whole. Do not crush, chew, or break the capsules.||
0741|035|H|Doing so can destroy the long action of the drug and may increase||
0741|036|H|side effects.||
0741|037|H|   The dosage is based on your medical condition and response to||
0741|038|H|treatment. Your doctor will adjust the dose to find the best dose||
0741|039|H|for you. Use this medication regularly and exactly as prescribed||
0741|040|H|in order to get the most benefit from it. To help you remember,||
0741|041|H|take it at the same time(s) each day.||
0741|042|H|   Phendimetrazine is usually taken for only a few weeks at a||
0741|043|H|time. It should not be taken with other appetite suppressants||
0741|044|H|(see also Drug Interactions section). The possibility of serious||
0741|045|H|side effects increases with longer use of this medication and use||
0741|046|H|of this drug along with certain other diet drugs.||
0741|047|H|   Caffeine can increase the side effects of this medication.||
0741|048|H|Avoid drinking large amounts of beverages containing caffeine||
0741|049|H|(coffee, tea, colas), eating large amounts of chocolate, or||
0741|050|H|taking nonprescription products that contain caffeine.||
0741|051|H|   If you suddenly stop using this medication, you may have||
0741|052|H|withdrawal symptoms (such as depression, severe tiredness). To||
0741|053|H|help prevent withdrawal, your doctor may lower your dose slowly.||
0741|054|H|Withdrawal is more likely if you have used phendimetrazine for a||
0741|055|H|long time or in high doses. Tell your doctor or pharmacist right||
0741|056|H|away if you have withdrawal.||
0741|057|H|   Though it helps many people, this medication may sometimes||
0741|058|H|cause addiction. This risk may be higher if you have a substance||
0741|059|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0741|060|H|Do not increase your dose, take it more often, or use it for a||
0741|061|H|longer time than prescribed. Properly stop the medication when so||
0741|062|H|directed.||
0741|063|H|   This medication may stop working well after you have been||
0741|064|H|taking it for a while. Talk with your doctor if this medication||
0741|065|H|stops working well. Do not increase the dose unless directed by||
0741|066|H|your doctor. Your doctor may direct you to stop taking this||
0741|067|H|medication.||
0741|068|B|||
0741|069|S|SIDE EFFECTS:  Dizziness, dry mouth, difficulty sleeping,||
0741|070|S|irritability, nausea, vomiting, diarrhea, or constipation may||
0741|071|S|occur. If these effects last or get worse, notify your doctor or||
0741|072|S|pharmacist promptly.||
0741|073|S|   Remember that this medication has been prescribed because your||
0741|074|S|doctor has judged that the benefit to you is greater than the||
0741|075|S|risk of side effects. Many people using this medication do not||
0741|076|S|have serious side effects.||
0741|077|S|   This medication may raise your blood pressure. Check your||
0741|078|S|blood pressure regularly and tell your doctor if the results are||
0741|079|S|high.||
0741|080|S|   Tell your doctor right away if you have any serious side||
0741|081|S|effects, including: fast/irregular/pounding heartbeat,||
0741|082|S|mental/mood changes (such as agitation, uncontrolled anger,||
0741|083|S|hallucinations, nervousness), uncontrolled muscle movements,||
0741|084|S|change in sexual ability/interest.||
0741|085|S|   Get medical help right away if you have any very serious side||
0741|086|S|effects, including: severe headache, trouble speaking, seizure,||
0741|087|S|weakness on one side of the body, vision changes (such as blurred||
0741|088|S|vision).||
0741|089|S|   This drug may rarely cause serious (sometimes fatal) lung or||
0741|090|S|heart problems (pulmonary hypertension, heart valve problems).||
0741|091|S|The risk increases with longer use of this medication and use of||
0741|092|S|this drug along with other appetite-suppressant drugs/herbal||
0741|093|S|products. If you notice any of the following serious side||
0741|094|S|effects, stop taking this medication and tell your doctor or||
0741|095|S|pharmacist right away: chest pain, difficulty breathing with||
0741|096|S|exercise, decreased ability to exercise, fainting, swelling of||
0741|097|S|the legs/ankles/feet.||
0741|098|S|   A very serious allergic reaction to this drug is rare.||
0741|099|S|However, get medical help right away if you notice any symptoms||
0741|100|S|of a serious allergic reaction, including: rash, itching/swelling||
0741|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0741|102|S|breathing.||
0741|103|S|   This is not a complete list of possible side effects. If you||
0741|104|S|notice other effects not listed above, contact your doctor or||
0741|105|S|pharmacist.||
0741|106|S|   In the US -||
0741|107|S|   Call your doctor for medical advice about side effects. You||
0741|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0741|109|S|www.fda.gov/medwatch.||
0741|110|S|   In Canada - Call your doctor for medical advice about side||
0741|111|S|effects. You may report side effects to Health Canada at||
0741|112|S|1-866-234-2345.||
0741|113|B|||
0741|114|P|PRECAUTIONS:  Before taking phendimetrazine, tell your doctor or||
0741|115|P|pharmacist if you are allergic to it; or to any other||
0741|116|P|sympathomimetic amines (including decongestants such as||
0741|117|P|pseudoephedrine, stimulants such as amphetamine, appetite||
0741|118|P|suppressants such as phentermine); or if you have any other||
0741|119|P|allergies. This product may contain inactive ingredients, which||
0741|120|P|can cause allergic reactions or other problems. Talk to your||
0741|121|P|pharmacist for more details.||
0741|122|P|   Before using this medication, tell your doctor or pharmacist||
0741|123|P|your medical history, especially of: diabetes, high blood||
0741|124|P|pressure, glaucoma, heart problems (such as chest pain, heart||
0741|125|P|attack, heart murmur, fast/irregular heartbeat, heart valve||
0741|126|P|problems), mental/mood problems (such as severe||
0741|127|P|anxiety/agitation, depression, psychosis, schizophrenia), high||
0741|128|P|blood pressure in the lungs (pulmonary hypertension), kidney||
0741|129|P|disease, seizure problem, stroke, overactive thyroid||
0741|130|P|(hyperthyroidism), personal or family history of a substance use||
0741|131|P|disorder (such as overuse of or addiction to drugs/alcohol).||
0741|132|P|   This drug may make you dizzy or blur your vision. It may also||
0741|133|P|rarely make you drowsy. Alcohol or marijuana (cannabis) can make||
0741|134|P|you more dizzy or drowsy. Do not drive, use machinery, or do||
0741|135|P|anything that needs alertness or clear vision until you can do it||
0741|136|P|safely. Avoid alcoholic beverages. Talk to your doctor if you are||
0741|137|P|using marijuana (cannabis).||
0741|138|P|   If you have diabetes, check your blood sugar regularly as||
0741|139|P|directed and share the results with your doctor. Your doctor may||
0741|140|P|need to adjust your diabetes medication during treatment with||
0741|141|P|this drug.||
0741|142|P|   Before having surgery, tell your doctor or dentist about all||
0741|143|P|the products you use (including prescription drugs,||
0741|144|P|nonprescription drugs, and herbal products).||
0741|145|P|   Older adults may be at greater risk for dizziness and high||
0741|146|P|blood pressure while using this drug.||
0741|147|P|   This medication must not be used during pregnancy. Weight loss||
0741|148|P|offers no potential benefit to a pregnant woman and may harm an||
0741|149|P|unborn baby. If you become pregnant or think you may be pregnant,||
0741|150|P|tell your doctor right away.||
0741|151|P|   It is unknown if this drug passes into breast milk. However,||
0741|152|P|similar drugs pass into breast milk. Breastfeeding is not||
0741|153|P|recommended while using this drug. Consult your doctor before||
0741|154|P|breastfeeding.||
0741|155|B|||
0741|156|I|DRUG INTERACTIONS:  See also How to Use section.||
0741|157|I|   Drug interactions may change how your medications work or||
0741|158|I|increase your risk for serious side effects. This document does||
0741|159|I|not contain all possible drug interactions. Keep a list of all||
0741|160|I|the products you use (including prescription/nonprescription||
0741|161|I|drugs and herbal products) and share it with your doctor and||
0741|162|I|pharmacist. Do not start, stop, or change the dosage of any||
0741|163|I|medicines without your doctor's approval.||
0741|164|I|   Some products that may interact with this drug are: stimulants||
0741|165|I|(including amphetamines, methylphenidate, street drugs such as||
0741|166|I|cocaine or MDMA/"ecstasy").||
0741|167|I|   This drug should not be used with certain medications because||
0741|168|I|very serious interactions may occur. If you are taking or have||
0741|169|I|taken other appetite-suppressant drugs in the past year (such as||
0741|170|I|phentermine, ephedra/ma huang), tell your doctor or pharmacist||
0741|171|I|before starting this medication.||
0741|172|I|   Taking MAO inhibitors with this medication may cause a serious||
0741|173|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0741|174|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0741|175|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0741|176|I|selegiline, tranylcypromine) during treatment with this||
0741|177|I|medication. Most MAO inhibitors should also not be taken for two||
0741|178|I|weeks before treatment with this medication. Ask your doctor when||
0741|179|I|to start or stop taking this medication.||
0741|180|I|   Tell your doctor or pharmacist if you are taking other||
0741|181|I|products that cause drowsiness such as opioid pain or cough||
0741|182|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0741|183|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0741|184|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0741|185|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0741|186|I|diphenhydramine).||
0741|187|I|   Check the labels on all your medicines (such as allergy or||
0741|188|I|cough-and-cold products) because they may contain ingredients||
0741|189|I|that cause drowsiness. Ask your pharmacist about using those||
0741|190|I|products safely.||
0741|191|I|   Some products have ingredients that could raise your heart||
0741|192|I|rate or blood pressure. Tell your pharmacist what products you||
0741|193|I|are using, and ask how to use them safely (especially||
0741|194|I|cough-and-cold products or diet aids).||
0741|195|B|||
0741|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0741|197|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0741|198|O|poison control center right away. US residents can call||
0741|199|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0741|200|O|Symptoms of overdose may include: rapid breathing, unusual||
0741|201|O|restlessness, fast/slow/irregular heartbeat, chest pain,||
0741|202|O|hallucinations, seizures, loss of consciousness.||
0741|203|B|||
0741|204|N|NOTES:  Appetite suppressants should not be used in place of||
0741|205|N|proper diet. For best results, this drug must be used along with||
0741|206|N|a doctor-approved diet and exercise program.||
0741|207|N|   Do not share this medication with others. Sharing it is||
0741|208|N|against the law.||
0741|209|N|   Lab and/or medical tests (such as blood pressure, heart/kidney||
0741|210|N|function) may be done while you are taking this medication. Keep||
0741|211|N|all medical and lab appointments. Consult your doctor for more||
0741|212|N|details.||
0741|213|B|||
0741|214|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0741|215|D|remember. If it is near the time of the next dose or late in the||
0741|216|D|evening, skip the missed dose. Take your next dose at the regular||
0741|217|D|time. Do not double the dose to catch up.||
0741|218|B|||
0741|219|R|STORAGE:  Store at room temperature away from light and moisture.||
0741|220|R|Do not store in the bathroom. Keep all medications away from||
0741|221|R|children and pets.||
0741|222|R|   Do not flush medications down the toilet or pour them into a||
0741|223|R|drain unless instructed to do so. Properly discard this product||
0741|224|R|when it is expired or no longer needed. Consult your pharmacist||
0741|225|R|or local waste disposal company.||
0741|226|B|||
0741|227|A|Information last revised July 2025.||
0741|228|A|Copyright(c) 2025 First Databank, Inc.||
0741|229|B|||
0742|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0742|002|Z|does NOT have all possible information about this product. This||
0742|003|Z|information does not assure that this product is safe, effective,||
0742|004|Z|or appropriate for you. This information is not individual||
0742|005|Z|medical advice and does not substitute for the advice of your||
0742|006|Z|health care professional. Always ask your health care||
0742|007|Z|professional for complete information about this product and your||
0742|008|Z|specific health needs.||
0742|009|B|||
0742|010|T|SELEGILINE RAPIDLY DISSOLVING TABLET - ORAL||
0742|011|F|(seh-LEDGE-uh-leen)||
0742|012|B|||
0742|013|C|COMMON BRAND NAME(S): Zelapar||
0742|014|B|||
0742|015|U|USES:  This medication is used with levodopa/carbidopa to treat||
0742|016|U|movement disorders caused by Parkinson's disease. It does not||
0742|017|U|cure Parkinson's disease, but it may improve shakiness (tremor),||
0742|018|U|muscle stiffness, and sudden switching between normal movement||
0742|019|U|and stiffness ("on-off" problems). It may improve your range of||
0742|020|U|motion and ability to walk, dress, and exercise.||
0742|021|U|   Selegiline is an enzyme blocker (MAO inhibitor) that works by||
0742|022|U|slowing the breakdown of certain natural substances in the brain||
0742|023|U|(neurotransmitters such as dopamine, norepinephrine, and||
0742|024|U|serotonin).||
0742|025|B|||
0742|026|H|HOW TO USE:  Take this medication by dissolving the tablet on the||
0742|027|H|tongue as directed by your doctor, usually once a day in the||
0742|028|H|morning. Do not swallow the tablet or the dissolved medication||
0742|029|H|with saliva or water. It should be absorbed through the lining of||
0742|030|H|the mouth. To prevent accidentally swallowing any of the||
0742|031|H|medication, do not eat or drink anything for at least 5 minutes||
0742|032|H|before or after using this product.||
0742|033|H|   Dry your hands before peeling back the foil on the blister||
0742|034|H|pack to carefully remove a tablet. Do not push the tablet through||
0742|035|H|the foil. Immediately place the tablet on the tongue and allow it||
0742|036|H|to dissolve completely. Do not crush, split, or break the tablet||
0742|037|H|before taking it. Do not remove the tablet from the blister pack||
0742|038|H|until just before taking. Taking selegiline late in the day may||
0742|039|H|cause trouble sleeping.||
0742|040|H|   The dosage is based on your medical condition and response to||
0742|041|H|treatment. Your doctor may change your dose to find the best dose||
0742|042|H|for you. Do not increase your dose or take it more often than||
0742|043|H|directed.||
0742|044|H|   Your doctor may direct you to lower your levodopa dose if you||
0742|045|H|are having more side effects while using selegiline. Follow your||
0742|046|H|doctor's instructions closely. Do not stop or change the dose of||
0742|047|H|any of your medications without first talking with your doctor.||
0742|048|H|   Use this medication regularly in order to get the most benefit||
0742|049|H|from it. To help you remember, use it at the same time each day.||
0742|050|H|   Do not stop taking this medication without consulting your||
0742|051|H|doctor. Some conditions may become worse when the drug is||
0742|052|H|suddenly stopped. Your dose may need to be gradually decreased.||
0742|053|H|   A very serious high blood pressure reaction may rarely occur||
0742|054|H|if you eat a large amount of tyramine while taking this||
0742|055|H|medication. Avoid foods that are high in tyramine, like aged||
0742|056|H|cheeses (such as Stilton cheese). Consult your doctor or||
0742|057|H|dietician about which foods you should avoid and if you do not||
0742|058|H|feel well after eating or drinking certain foods while taking||
0742|059|H|this medication. See also Side Effects section.||
0742|060|H|   It may take a few weeks for the full benefits of the drug to||
0742|061|H|be noticed. Talk with your doctor if the medication stops working||
0742|062|H|well or if your condition gets worse.||
0742|063|B|||
0742|064|S|SIDE EFFECTS:  Dizziness, abdominal pain, dry mouth, nausea,||
0742|065|S|stomach upset, trouble sleeping, and headache may occur. Redness,||
0742|066|S|pain, and swelling of the mouth/throat may also occur. If any of||
0742|067|S|these effects last or get worse, notify your doctor or pharmacist||
0742|068|S|promptly.||
0742|069|S|   To reduce the risk of dizziness and lightheadedness, get up||
0742|070|S|slowly when rising from a sitting or lying position.||
0742|071|S|   If you are also taking levodopa, you may experience more side||
0742|072|S|effects from the levodopa when taking selegiline. Tell your||
0742|073|S|doctor right away if any of these side effects occur: nausea,||
0742|074|S|shakiness, muscle stiffness, mental/mood changes such as||
0742|075|S|hallucinations/abnormal dreams. Your doctor may need to change||
0742|076|S|your medication or dose. Do not stop or change the dose of your||
0742|077|S|levodopa without talking with your doctor first.||
0742|078|S|   Remember that this medication has been prescribed because your||
0742|079|S|doctor has judged that the benefit to you is greater than the||
0742|080|S|risk of side effects. Many people using this medication do not||
0742|081|S|have serious side effects.||
0742|082|S|   Some people taking selegiline have fallen asleep suddenly||
0742|083|S|during their usual daily activities (such as talking on the||
0742|084|S|phone, driving). In some cases, sleep occurred without any||
0742|085|S|feelings of drowsiness beforehand. This sleep effect may occur||
0742|086|S|anytime during treatment with selegiline even if you have used||
0742|087|S|this medication for a long time. If you experience increased||
0742|088|S|sleepiness or fall asleep during the day, do not drive or take||
0742|089|S|part in other possibly dangerous activities until you have||
0742|090|S|discussed this effect with your doctor. Your risk of this sleep||
0742|091|S|effect is increased by using alcohol or other medications that||
0742|092|S|can make you drowsy. See also Precautions section.||
0742|093|S|   Tell your doctor right away if you have any serious side||
0742|094|S|effects, including: fainting, loss of balance, mental/mood||
0742|095|S|changes (such as agitation, confusion, depression,||
0742|096|S|hallucinations), unusual strong urges (such as increased||
0742|097|S|gambling, increased sexual urges), worsening muscle||
0742|098|S|stiffness/twitching, changes in sexual ability/interest,||
0742|099|S|increased shaking (tremor), swollen ankles/legs, difficulty||
0742|100|S|urinating, unusual weight gain, easy bleeding/bruising,||
0742|101|S|black/tarry stools, vomit that looks like coffee grounds.||
0742|102|S|   This drug may rarely cause an attack of extremely high blood||
0742|103|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
0742|104|S|food interactions can increase this risk (See also How to Use and||
0742|105|S|Drug Interactions sections). Get medical help right away if any||
0742|106|S|of these serious side effects occur: frequent/severe headache,||
0742|107|S|fast/slow/irregular/pounding heartbeat, chest pain, neck||
0742|108|S|stiffness/soreness, severe nausea/vomiting, sweating/clammy skin||
0742|109|S|(sometimes with fever), widened pupils, vision changes (such as||
0742|110|S|double/blurred vision), sudden sensitivity to light||
0742|111|S|(photophobia).||
0742|112|S|   This medication may increase serotonin and rarely cause a very||
0742|113|S|serious condition called serotonin syndrome. The risk increases||
0742|114|S|if you are also taking other drugs that increase serotonin, so||
0742|115|S|tell your doctor or pharmacist of all the drugs you take. Get||
0742|116|S|medical help right away if you develop some of the following||
0742|117|S|symptoms: hallucinations, unusual restlessness, loss of||
0742|118|S|coordination, fast heartbeat, severe dizziness, unexplained||
0742|119|S|fever, severe nausea/vomiting/diarrhea, twitching muscle.||
0742|120|S|   A very serious allergic reaction to this drug is rare.||
0742|121|S|However, get medical help right away if you notice any symptoms||
0742|122|S|of a serious allergic reaction, including: rash, itching/swelling||
0742|123|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0742|124|S|breathing.||
0742|125|S|   This is not a complete list of possible side effects. If you||
0742|126|S|notice other effects not listed above, contact your doctor or||
0742|127|S|pharmacist.||
0742|128|S|   In the US -||
0742|129|S|   Call your doctor for medical advice about side effects. You||
0742|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0742|131|S|www.fda.gov/medwatch.||
0742|132|S|   In Canada - Call your doctor for medical advice about side||
0742|133|S|effects. You may report side effects to Health Canada at||
0742|134|S|1-866-234-2345.||
0742|135|B|||
0742|136|P|PRECAUTIONS:  Before taking selegiline, tell your doctor or||
0742|137|P|pharmacist if you are allergic to it; or if you have any other||
0742|138|P|allergies. This product may contain inactive ingredients, which||
0742|139|P|can cause allergic reactions or other problems. Talk to your||
0742|140|P|pharmacist for more details.||
0742|141|P|   Before using this medication, tell your doctor or pharmacist||
0742|142|P|your medical history, especially of: a certain adrenal gland||
0742|143|P|tumor (pheochromocytoma), cerebrovascular disease (such as||
0742|144|P|stroke), heart problems (such as heart failure, heart attack),||
0742|145|P|bleeding problems, peptic ulcer, history of severe/frequent||
0742|146|P|headaches, diabetes, personal/family history of mental/mood||
0742|147|P|disorders (such as schizophrenia, bipolar disorder),||
0742|148|P|personal/family history of high blood pressure, kidney disease,||
0742|149|P|liver disease, overactive thyroid (hyperthyroidism).||
0742|150|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0742|151|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0742|152|P|machinery, or do anything that needs alertness until you can do||
0742|153|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0742|154|P|are using marijuana (cannabis). See also Side Effects section.||
0742|155|P|   Before having surgery, tell your doctor or dentist about all||
0742|156|P|the products you use (including prescription drugs,||
0742|157|P|nonprescription drugs, and herbal products). You may need to stop||
0742|158|P|taking selegiline before surgery. Follow your doctor's||
0742|159|P|instructions carefully.||
0742|160|P|   This medicine may contain aspartame. If you have||
0742|161|P|phenylketonuria (PKU) or any other condition that requires you to||
0742|162|P|restrict your intake of aspartame (or phenylalanine), consult||
0742|163|P|your doctor or pharmacist about using this drug safely.||
0742|164|P|   Older adults may be more sensitive to the side effects of this||
0742|165|P|drug, especially dizziness from low blood pressure.||
0742|166|P|   During pregnancy, selegiline should be used only when clearly||
0742|167|P|needed. Discuss the risks and benefits with your doctor.||
0742|168|P|   It is unknown if this drug passes into breast milk. Because of||
0742|169|P|the possible risk to the infant, breastfeeding is not recommended||
0742|170|P|while using this drug and for 7 days after the last dose. Consult||
0742|171|P|your doctor before breastfeeding.||
0742|172|B|||
0742|173|I|DRUG INTERACTIONS:  See also How to Use section.||
0742|174|I|   Drug interactions may change how your medications work or||
0742|175|I|increase your risk for serious side effects. This document does||
0742|176|I|not contain all possible drug interactions. Keep a list of all||
0742|177|I|the products you use (including prescription/nonprescription||
0742|178|I|drugs and herbal products) and share it with your doctor and||
0742|179|I|pharmacist. Do not start, stop, or change the dosage of any||
0742|180|I|medicines without your doctor's approval.||
0742|181|I|   Some products that may interact with selegiline include:||
0742|182|I|antidepressants (including bupropion, maprotiline, mirtazapine),||
0742|183|I|other MAO inhibitors (isocarboxazid, linezolid, metaxalone,||
0742|184|I|methylene blue, moclobemide, phenelzine, procarbazine,||
0742|185|I|rasagiline, safinamide, tranylcypromine), appetite suppressants||
0742|186|I|(such as diethylpropion), drugs for attention deficit disorder||
0742|187|I|(such as atomoxetine, methylphenidate), apraclonidine, buspirone,||
0742|188|I|carbamazepine/oxcarbazepine, cyclobenzaprine, deutetrabenazine,||
0742|189|I|fentanyl, metoclopramide, street drugs (such as LSD, mescaline),||
0742|190|I|supplements (such as tryptophan, tyramine), tetrabenazine,||
0742|191|I|certain "triptans" used to treat migraine headaches (such as||
0742|192|I|rizatriptan, sumatriptan, zolmitriptan), valbenazine.||
0742|193|I|   The risk of serotonin syndrome/toxicity increases if you are||
0742|194|I|also taking other drugs that increase serotonin. Examples include||
0742|195|I|street drugs such as MDMA/"ecstasy," St. John's wort,||
0742|196|I|dextromethorphan, certain antidepressants (including SSRIs such||
0742|197|I|as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine,||
0742|198|I|TCAs such as amitriptyline/doxepin), certain opioid medications||
0742|199|I|(such as meperidine, methadone, pentazocine, propoxyphene,||
0742|200|I|tramadol, tapentadol), among others. The risk of serotonin||
0742|201|I|syndrome/toxicity may be more likely when you start or increase||
0742|202|I|the dose of these drugs.||
0742|203|I|   Tell your doctor or pharmacist if you are using any of these||
0742|204|I|medications before, during, or within 2 weeks after treatment||
0742|205|I|with selegiline. Tell your doctor or pharmacist if you have taken||
0742|206|I|fluoxetine during at least 5 weeks before starting selegiline.||
0742|207|I|Discuss with your doctor how much time to wait between starting||
0742|208|I|or stopping any of these drugs and taking selegiline.||
0742|209|I|   Before using selegiline, report the use of drugs that may||
0742|210|I|increase the risk of extremely high blood pressure (hypertensive||
0742|211|I|crisis) when combined with selegiline, including herbal products||
0742|212|I|(such as ephedra/ma huang), nasal decongestants (such as||
0742|213|I|phenylephrine, pseudoephedrine), and stimulants (such as||
0742|214|I|amphetamines, ephedrine, epinephrine, phenylalanine). Selegiline||
0742|215|I|should not be used with any of these medications. Talk to your||
0742|216|I|doctor or pharmacist for more details.||
0742|217|I|   Check the labels on all your medicines (such as allergy,||
0742|218|I|cough-and-cold products, diet pills) because they may contain||
0742|219|I|dextromethorphan, decongestants, or stimulants. Ask your||
0742|220|I|pharmacist about the safe use of those products.||
0742|221|I|   This medication may interfere with certain medical/lab tests||
0742|222|I|(such as brain scan for Parkinson's disease), possibly causing||
0742|223|I|false test results. Make sure lab personnel and all your doctors||
0742|224|I|know you use this drug.||
0742|225|B|||
0742|226|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0742|227|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0742|228|O|poison control center right away. US residents can call||
0742|229|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0742|230|O|Symptoms of overdose may not appear for up to 12 hours and may||
0742|231|O|include: restlessness, weakness, drowsiness, flushing, sweating,||
0742|232|O|fast heartbeat, confusion, seizures. You may need to follow a||
0742|233|O|tyramine-restricted diet for several weeks after a suspected||
0742|234|O|overdose.||
0742|235|B|||
0742|236|N|NOTES:  Do not share this medication with others.||
0742|237|N|   Lab and/or medical tests (such as blood pressure) should be||
0742|238|N|done while you are taking this medication. Keep all medical and||
0742|239|N|lab appointments. Consult your doctor for more details.||
0742|240|B|||
0742|241|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0742|242|D|remember. If it is near the time of the next dose, skip the||
0742|243|D|missed dose. Take your next dose at the regular time. Do not||
0742|244|D|double the dose to catch up.||
0742|245|B|||
0742|246|R|STORAGE:  Store at room temperature away from light and moisture.||
0742|247|R|Keep the blister packets in the pouch provided. Once the pouch is||
0742|248|R|opened, this medication expires after 3 months. Do not open||
0742|249|R|blister packet until you are ready to use the medication. Do not||
0742|250|R|store in the bathroom. Keep all medications away from children||
0742|251|R|and pets.||
0742|252|R|   Do not flush medications down the toilet or pour them into a||
0742|253|R|drain unless instructed to do so. Properly discard this product||
0742|254|R|when it is expired or no longer needed. Consult your pharmacist||
0742|255|R|or local waste disposal company.||
0742|256|B|||
0742|257|A|Information last revised November 2025.||
0742|258|A|Copyright(c) 2025 First Databank, Inc.||
0742|259|B|||
0743|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0743|002|Z|does NOT have all possible information about this product. This||
0743|003|Z|information does not assure that this product is safe, effective,||
0743|004|Z|or appropriate for you. This information is not individual||
0743|005|Z|medical advice and does not substitute for the advice of your||
0743|006|Z|health care professional. Always ask your health care||
0743|007|Z|professional for complete information about this product and your||
0743|008|Z|specific health needs.||
0743|009|B|||
0743|010|T|GENTIAN VIOLET SOLUTION - TOPICAL||
0743|011|F|(JEN-shun vye-oh-LET)||
0743|012|B|||
0743|013|U|USES:  Gentian violet is an antiseptic dye used to treat fungal||
0743|014|U|infections of the skin (such as ringworm, athlete's foot). It||
0743|015|U|also has weak antibacterial effects and may be used on minor cuts||
0743|016|U|and scrapes to prevent infection.||
0743|017|U|   This product has been withdrawn from the Canadian market due||
0743|018|U|to safety problems.||
0743|019|B|||
0743|020|V|OTHER USES:  This section contains uses of this drug that are not||
0743|021|V|listed in the approved professional labeling for the drug but||
0743|022|V|that may be prescribed by your health care professional. Use this||
0743|023|V|drug for a condition that is listed in this section only if it||
0743|024|V|has been so prescribed by your health care professional.||
0743|025|V|   Your doctor may also prescribe this medication for fungal||
0743|026|V|infections of the mouth (thrush).||
0743|027|B|||
0743|028|H|HOW TO USE:  Follow all directions on the product package. If you||
0743|029|H|have any questions, ask your doctor or pharmacist.||
0743|030|H|   Before use, clean the affected area, rinse well, and pat dry.||
0743|031|H|Make sure the area is dry before using this medication. Using a||
0743|032|H|cotton swab to avoid staining your hands, apply gentian violet to||
0743|033|H|the affected area, usually once or twice a day or as directed by||
0743|034|H|your doctor. Apply only to the affected area, and avoid||
0743|035|H|surrounding healthy skin.||
0743|036|H|   Wash hands immediately after use unless the area being treated||
0743|037|H|includes the hands. Avoid getting the product in your eyes. If||
0743|038|H|the medication gets into your eyes, rinse the area immediately||
0743|039|H|with clean water for at least 15 minutes. Seek medical attention||
0743|040|H|if your eye becomes irritated.||
0743|041|H|   Do not cover the area with plastic or waterproof bandages.||
0743|042|H|Covering the area may increase the risk of skin irritation.||
0743|043|H|   This product is for use on the outside of the body only. Do||
0743|044|H|not apply inside the mouth, nose, or ears unless directed by your||
0743|045|H|doctor. This medication is a dye and will stain skin and||
0743|046|H|clothing. Do not apply to open sores (skin ulcers). This may||
0743|047|H|cause permanent "tattooing" of the skin.||
0743|048|H|   If your doctor has prescribed this medication for areas in the||
0743|049|H|mouth, you/your child must be careful to avoid swallowing the||
0743|050|H|medication. If you have any questions about proper use, ask your||
0743|051|H|health care professional.||
0743|052|H|   Use this medication regularly in order to get the most benefit||
0743|053|H|from it. To help you remember, use it at the same time(s) each||
0743|054|H|day. If your doctor has prescribed this medication, continue to||
0743|055|H|use it until the full prescribed amount is finished, even if||
0743|056|H|symptoms improve after a few days. Stopping the medication too||
0743|057|H|early may allow the infection to return.||
0743|058|H|   Tell your doctor if the condition does not get better in 3||
0743|059|H|days or if it gets worse. If you think you may have a serious||
0743|060|H|medical problem, get medical help right away.||
0743|061|B|||
0743|062|S|SIDE EFFECTS:  Redness, swelling, or irritation at the||
0743|063|S|application site may occur. If any of these effects last or get||
0743|064|S|worse, tell your doctor or pharmacist promptly.||
0743|065|S|   If your doctor has directed you to use this medication,||
0743|066|S|remember that your doctor has judged that the benefit to you is||
0743|067|S|greater than the risk of side effects. Many people using this||
0743|068|S|medication do not have serious side effects.||
0743|069|S|   Stop using this medication and tell your doctor right away if||
0743|070|S|you have any serious side effects, including: new signs of a skin||
0743|071|S|infection (heat, tenderness, pus), skin sores.||
0743|072|S|   Skin sores are more likely to develop when the medication is||
0743|073|S|applied to skin folds (such as between the toes, beneath the||
0743|074|S|breasts). Be careful to apply only a small amount to skin fold||
0743|075|S|areas, and allow to dry completely before putting on shoes or||
0743|076|S|clothing.||
0743|077|S|   A very serious allergic reaction to this product is rare.||
0743|078|S|However, get medical help right away if you notice any symptoms||
0743|079|S|of a serious allergic reaction, including: rash, itching/swelling||
0743|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0743|081|S|breathing.||
0743|082|S|   This is not a complete list of possible side effects. If you||
0743|083|S|notice other effects not listed above, contact your doctor or||
0743|084|S|pharmacist.||
0743|085|S|   In the US -||
0743|086|S|   Call your doctor for medical advice about side effects. You||
0743|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0743|088|S|www.fda.gov/medwatch.||
0743|089|S|   In Canada - Call your doctor for medical advice about side||
0743|090|S|effects. You may report side effects to Health Canada at||
0743|091|S|1-866-234-2345.||
0743|092|B|||
0743|093|P|PRECAUTIONS:  Before using gentian violet, tell your doctor or||
0743|094|P|pharmacist if you are allergic to it; or to other dyes; or if you||
0743|095|P|have any other allergies. This product may contain inactive||
0743|096|P|ingredients, which can cause allergic reactions or other||
0743|097|P|problems. Talk to your pharmacist for more details.||
0743|098|P|   If you have a certain metabolic disease (porphyria), consult||
0743|099|P|your doctor or pharmacist before using this product.||
0743|100|P|   Tell your doctor if you are pregnant before using this||
0743|101|P|medication.||
0743|102|P|   It is unlikely that this product passes into breast milk.||
0743|103|P|Consult your doctor before breastfeeding.||
0743|104|B|||
0743|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0743|106|I|medications work or increase your risk for serious side effects.||
0743|107|I|This document does not contain all possible drug interactions.||
0743|108|I|Keep a list of all the products you use (including||
0743|109|I|prescription/nonprescription drugs and herbal products) and share||
0743|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0743|111|I|the dosage of any medicines without your doctor's approval.||
0743|112|B|||
0743|113|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0743|114|O|has overdosed and has serious symptoms such as passing out or||
0743|115|O|trouble breathing, call 911. Otherwise, call a poison control||
0743|116|O|center right away. US residents can call 1-800-222-1222. Canada||
0743|117|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0743|118|O|include: nausea, vomiting, diarrhea.||
0743|119|B|||
0743|120|N|NOTES:  Keep all medical and lab appointments.||
0743|121|B|||
0743|122|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0743|123|D|If it is near the time of the next dose, skip the missed dose.||
0743|124|D|Use your next dose at the regular time. Do not double the dose to||
0743|125|D|catch up.||
0743|126|B|||
0743|127|R|STORAGE:  Refer to storage information printed on the package. If||
0743|128|R|you have any questions about storage, ask your pharmacist. Keep||
0743|129|R|all medications and herbal products away from children and pets.||
0743|130|R|   Do not flush medications down the toilet or pour them into a||
0743|131|R|drain unless instructed to do so. Properly discard this product||
0743|132|R|when it is expired or no longer needed. Consult your pharmacist||
0743|133|R|or local waste disposal company.||
0743|134|B|||
0743|135|A|Information last revised November 2024.||
0743|136|A|Copyright(c) 2025 First Databank, Inc.||
0743|137|B|||
0744|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0744|002|Z|does NOT have all possible information about this product. This||
0744|003|Z|information does not assure that this product is safe, effective,||
0744|004|Z|or appropriate for you. This information is not individual||
0744|005|Z|medical advice and does not substitute for the advice of your||
0744|006|Z|health care professional. Always ask your health care||
0744|007|Z|professional for complete information about this product and your||
0744|008|Z|specific health needs.||
0744|009|B|||
0744|010|T|DEXAMETHASONE CONCENTRATE SOLUTION - ORAL||
0744|011|F|(dex-uh-METH-uh-sown)||
0744|012|B|||
0744|013|C|COMMON BRAND NAME(S): Dexamethasone Intensol||
0744|014|B|||
0744|015|U|USES:  Dexamethasone is used to treat conditions such as||
0744|016|U|arthritis, blood/hormone disorders, allergic reactions, skin||
0744|017|U|diseases, eye problems, breathing problems, bowel disorders,||
0744|018|U|cancer, and immune system disorders. It is also used as a test||
0744|019|U|for an adrenal gland disorder (Cushing's syndrome).||
0744|020|U|   Dexamethasone belongs to a class of drugs known as||
0744|021|U|corticosteroids. It decreases your immune system's response to||
0744|022|U|various diseases to reduce symptoms such as swelling and||
0744|023|U|allergic-type reactions.||
0744|024|B|||
0744|025|V|OTHER USES:  This section contains uses of this drug that are not||
0744|026|V|listed in the approved professional labeling for the drug but||
0744|027|V|that may be prescribed by your health care professional. Use this||
0744|028|V|drug for a condition that is listed in this section only if it||
0744|029|V|has been so prescribed by your health care professional.||
0744|030|V|   This drug may also be used to reduce the risk of nausea and||
0744|031|V|vomiting caused by cancer chemotherapy.||
0744|032|V|   Dexamethasone may also be used for COVID-19, but is only||
0744|033|V|effective in hospitalized patients who need supplemental oxygen||
0744|034|V|or a mechanical ventilator to breathe.||
0744|035|B|||
0744|036|H|HOW TO USE:  Take this medication by mouth as directed by your||
0744|037|H|doctor. Take with food or milk to prevent stomach upset.||
0744|038|H|   Before using this medication, check the liquid for particles.||
0744|039|H|Do not use this medication if it contains any particles.||
0744|040|H|   Use only the dropper provided with the product. Draw the||
0744|041|H|prescribed amount of the medication into the dropper, and then||
0744|042|H|squeeze into liquid (such as water, juice, soda) or semi-solid||
0744|043|H|food (such as applesauce, pudding). Stir the liquid or food||
0744|044|H|gently for a few seconds. Take the entire amount of the drug and||
0744|045|H|liquid/food mixture by mouth right away. Do not save for later.||
0744|046|H|   If you take this medication once daily, take it in the morning||
0744|047|H|before 9 AM. If you are taking this medication every other day or||
0744|048|H|on another schedule besides a daily one, it may help to mark your||
0744|049|H|calendar with a reminder.||
0744|050|H|   The dosage and length of treatment are based on your medical||
0744|051|H|condition and response to treatment. Take this medication exactly||
0744|052|H|as prescribed. Follow the dosing schedule carefully. Your doctor||
0744|053|H|may attempt to reduce your dose slowly from time to time to||
0744|054|H|minimize side effects.||
0744|055|H|   Do not stop taking this medication without consulting your||
0744|056|H|doctor. Some conditions may become worse when this drug is||
0744|057|H|suddenly stopped. Also, you may experience symptoms such as||
0744|058|H|nausea, dizziness, weakness, or muscle/joint pain. To prevent||
0744|059|H|these symptoms while you are stopping treatment with this drug,||
0744|060|H|your doctor may reduce your dose gradually. Consult your doctor||
0744|061|H|or pharmacist for more details. Report any new or worsening||
0744|062|H|symptoms right away.||
0744|063|H|   Tell your doctor if your condition does not get better or if||
0744|064|H|it gets worse.||
0744|065|B|||
0744|066|S|SIDE EFFECTS:  Stomach upset, heartburn, headache, trouble||
0744|067|S|sleeping, or increased appetite may occur. If any of these||
0744|068|S|effects last or get worse, tell your doctor or pharmacist||
0744|069|S|promptly.||
0744|070|S|   Remember that this medication has been prescribed because your||
0744|071|S|doctor has judged that the benefit to you is greater than the||
0744|072|S|risk of side effects. Many people using this medication do not||
0744|073|S|have serious side effects.||
0744|074|S|   Tell your doctor right away if you have any serious side||
0744|075|S|effects, including: signs of infection (such as sore throat that||
0744|076|S|doesn't go away, fever, chills), bone/joint pain,||
0744|077|S|fast/slow/irregular heartbeat, eye pain/pressure, vision||
0744|078|S|problems, unusual weight gain, puffy face, swelling of the||
0744|079|S|ankles/feet, symptoms of stomach/intestinal bleeding (such as||
0744|080|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
0744|081|S|coffee grounds), mental/mood changes (such as depression, mood||
0744|082|S|swings, agitation), menstrual period changes, muscle pain/cramps,||
0744|083|S|weakness, easy bruising/bleeding, slow wound healing, thinning||
0744|084|S|skin, seizures, red/purple spots on the skin.||
0744|085|S|   This medication may rarely make your blood sugar rise, which||
0744|086|S|can cause or worsen diabetes. Tell your doctor right away if you||
0744|087|S|have symptoms of high blood sugar such as increased||
0744|088|S|thirst/urination. If you already have diabetes, check your blood||
0744|089|S|sugar regularly as directed and share the results with your||
0744|090|S|doctor. Your doctor may need to adjust your diabetes medication,||
0744|091|S|exercise program, or diet.||
0744|092|S|   A very serious allergic reaction to this drug is rare.||
0744|093|S|However, get medical help right away if you notice any symptoms||
0744|094|S|of a serious allergic reaction, including: rash, itching/swelling||
0744|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0744|096|S|breathing.||
0744|097|S|   This is not a complete list of possible side effects. If you||
0744|098|S|notice other effects not listed above, contact your doctor or||
0744|099|S|pharmacist.||
0744|100|S|   In the US -||
0744|101|S|   Call your doctor for medical advice about side effects. You||
0744|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0744|103|S|www.fda.gov/medwatch.||
0744|104|S|   In Canada - Call your doctor for medical advice about side||
0744|105|S|effects. You may report side effects to Health Canada at||
0744|106|S|1-866-234-2345.||
0744|107|B|||
0744|108|P|PRECAUTIONS:  Before taking dexamethasone, tell your doctor or||
0744|109|P|pharmacist if you are allergic to it; or if you have any other||
0744|110|P|allergies. This product may contain inactive ingredients, which||
0744|111|P|can cause allergic reactions or other problems. Talk to your||
0744|112|P|pharmacist for more details.||
0744|113|P|   Before using this medication, tell your doctor or pharmacist||
0744|114|P|your medical history, especially of: infections (such as||
0744|115|P|tuberculosis, herpes, fungal infection), kidney disease, liver||
0744|116|P|disease (such as hepatitis B), mental/mood disorders (such as||
0744|117|P|psychosis, anxiety, depression), mineral imbalance (such as low||
0744|118|P|level of potassium/calcium in the blood), thyroid disease,||
0744|119|P|stomach/intestinal problems (such as ulcer, ulcerative colitis,||
0744|120|P|diverticulitis, unexplained diarrhea), high blood pressure, heart||
0744|121|P|problems (such as heart failure, recent heart attack), diabetes,||
0744|122|P|eye diseases (such as cataracts, glaucoma), bone loss||
0744|123|P|(osteoporosis), blood clots, a certain adrenal gland tumor||
0744|124|P|(pheochromocytoma).||
0744|125|P|   Using corticosteroid medications for a long time can make it||
0744|126|P|more difficult for your body to respond to physical stress.||
0744|127|P|Before having surgery or emergency treatment, or if you get a||
0744|128|P|serious illness/injury, tell your doctor or dentist that you are||
0744|129|P|using this medication or have used this medication within the||
0744|130|P|past 12 months. Tell your doctor right away if you develop||
0744|131|P|unusual/extreme tiredness or weight loss. If you will be using||
0744|132|P|this medication for a long time, carry a warning card or medical||
0744|133|P|ID bracelet that identifies your use of this medication.||
0744|134|P|   This medication may mask signs of infection. It can make you||
0744|135|P|more likely to get infections or may make current infections||
0744|136|P|worse. Stay away from anyone who has an infection that may easily||
0744|137|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0744|138|P|doctor if you have been exposed to an infection or for more||
0744|139|P|details.||
0744|140|P|   This medication may cause stomach bleeding. Daily use of||
0744|141|P|alcohol while using this medication may increase your risk for||
0744|142|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
0744|143|P|or pharmacist for more information.||
0744|144|P|   Tell your health care professional that you are using||
0744|145|P|dexamethasone before having any immunizations/vaccinations. Avoid||
0744|146|P|contact with people who have recently received live vaccines||
0744|147|P|(such as flu vaccine inhaled through the nose).||
0744|148|P|   This product contains alcohol. Caution is advised if you have||
0744|149|P|alcohol dependence, liver disease, or any other condition that||
0744|150|P|requires you to limit/avoid alcohol in your diet. Ask your doctor||
0744|151|P|or pharmacist about using this product safely.||
0744|152|P|   Older adults may be more sensitive to the side effects of this||
0744|153|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
0744|154|P|mental/mood changes (such as confusion).||
0744|155|P|   This medication may slow down a child's growth if used for a||
0744|156|P|long time. Consult the doctor or pharmacist for more details. See||
0744|157|P|the doctor regularly so your child's height and growth can be||
0744|158|P|checked.||
0744|159|P|   During pregnancy, this medication should be used only when||
0744|160|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
0744|161|P|risks and benefits with your doctor. Infants born to mothers who||
0744|162|P|have been using this medication for an extended time may have||
0744|163|P|hormone problems. Tell your doctor right away if you notice||
0744|164|P|symptoms such as nausea/vomiting that doesn't stop, severe||
0744|165|P|diarrhea, or weakness in your newborn.||
0744|166|P|   It is unknown if this medication passes into breast milk.||
0744|167|P|Consult your doctor before breastfeeding.||
0744|168|B|||
0744|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0744|170|I|medications work or increase your risk for serious side effects.||
0744|171|I|This document does not contain all possible drug interactions.||
0744|172|I|Keep a list of all the products you use (including||
0744|173|I|prescription/nonprescription drugs and herbal products) and share||
0744|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
0744|175|I|the dosage of any medicines without your doctor's approval.||
0744|176|I|   Some products that may interact with this drug include:||
0744|177|I|aldesleukin, desmopressin, drugs that can cause bleeding/bruising||
0744|178|I|(including antiplatelet drugs such as clopidogrel, "blood||
0744|179|I|thinners" such as dabigatran/warfarin, NSAIDs such as||
0744|180|I|aspirin/celecoxib/ibuprofen), mifepristone.||
0744|181|I|   This medication can speed up the removal of other medications||
0744|182|I|from your body, which may affect how they work. Examples of||
0744|183|I|affected drugs include certain cancer drugs (such as dasatinib,||
0744|184|I|lapatinib, sunitinib), praziquantel, rilpivirine, among others.||
0744|185|I|   If your doctor has told you to take low-dose aspirin to||
0744|186|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0744|187|I|you should keep taking the aspirin unless your doctor tells you||
0744|188|I|not to. Ask your doctor or pharmacist for more details.||
0744|189|I|   This medication may interfere with certain lab tests||
0744|190|I|(including skin tests), possibly causing false test results. Make||
0744|191|I|sure lab personnel and all your doctors know you use this drug.||
0744|192|B|||
0744|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0744|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0744|195|O|poison control center right away. US residents can call||
0744|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0744|197|B|||
0744|198|N|NOTES:  Do not share this medication with others.||
0744|199|N|   If this medication is used for a long time, lab and/or medical||
0744|200|N|tests (such as blood mineral levels, blood glucose, complete||
0744|201|N|blood count, bone density tests, blood pressure, eye exams)||
0744|202|N|should be done while you are taking this medication. Keep all||
0744|203|N|medical and lab appointments. Consult your doctor for more||
0744|204|N|details.||
0744|205|N|   This medication may cause bone loss (osteoporosis) when used||
0744|206|N|for a long time. Lifestyle changes that may help reduce the risk||
0744|207|N|of bone problems include doing weight-bearing exercise, stopping||
0744|208|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
0744|209|N|D. Talk to your doctor for more details.||
0744|210|B|||
0744|211|D|MISSED DOSE:  If you are taking this medication daily and on a||
0744|212|D|regular schedule, and you miss a dose, take it as soon as you||
0744|213|D|remember. If it is near the time of the next dose, skip the||
0744|214|D|missed dose. Take your next dose at the regular time. Do not||
0744|215|D|double the dose to catch up.||
0744|216|D|   If you are taking this medication every other day or are||
0744|217|D|slowly reducing your dose, and you miss a dose, then ask your||
0744|218|D|doctor or pharmacist right away for a new dosing schedule.||
0744|219|B|||
0744|220|R|STORAGE:  Store at room temperature. Do not freeze. Once the||
0744|221|R|bottle is opened, this medication expires after 90 days. Keep all||
0744|222|R|medications away from children and pets.||
0744|223|R|   Do not flush medications down the toilet or pour them into a||
0744|224|R|drain unless instructed to do so. Properly discard this product||
0744|225|R|when it is expired or no longer needed. Consult your pharmacist||
0744|226|R|or local waste disposal company.||
0744|227|B|||
0744|228|M|MEDICAL ALERT:  Your condition can cause complications in a||
0744|229|M|medical emergency. For information about enrolling in MedicAlert,||
0744|230|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0744|231|B|||
0744|232|A|Information last revised September 2025.||
0744|233|A|Copyright(c) 2025 First Databank, Inc.||
0744|234|B|||
0745|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0745|002|Z|does NOT have all possible information about this product. This||
0745|003|Z|information does not assure that this product is safe, effective,||
0745|004|Z|or appropriate for you. This information is not individual||
0745|005|Z|medical advice and does not substitute for the advice of your||
0745|006|Z|health care professional. Always ask your health care||
0745|007|Z|professional for complete information about this product and your||
0745|008|Z|specific health needs.||
0745|009|B|||
0745|010|T|DASATINIB - ORAL||
0745|011|F|(da-SA-ti-nib)||
0745|012|B|||
0745|013|C|COMMON BRAND NAME(S): Sprycel||
0745|014|B|||
0745|015|U|USES:  This medication is used to treat certain types of cancer||
0745|016|U|(chronic myeloid leukemia-CML, acute lymphoblastic leukemia-ALL).||
0745|017|U|It works by slowing or stopping the growth of cancer cells.||
0745|018|B|||
0745|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0745|020|H|from your pharmacist before you start taking dasatinib and each||
0745|021|H|time you get a refill. If you have any questions, ask your doctor||
0745|022|H|or pharmacist.||
0745|023|H|   Take this medication by mouth with or without food as directed||
0745|024|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
0745|025|H|not crush, chew, or break the tablets.||
0745|026|H|   The dosage is based on your medical condition, response to||
0745|027|H|treatment, lab tests, and other medications you may be taking.||
0745|028|H|Children's dosage is also based on weight. Be sure to tell your||
0745|029|H|doctor and pharmacist about all the products you use (including||
0745|030|H|prescription drugs, nonprescription drugs, and herbal products).||
0745|031|H|   Do not increase your dose or use this drug more often or for||
0745|032|H|longer than prescribed. Your condition will not improve any||
0745|033|H|faster, and your risk of serious side effects will increase.||
0745|034|H|   Avoid taking antacids (such as aluminum/magnesium hydroxide,||
0745|035|H|calcium carbonate) within 2 hours before or after taking this||
0745|036|H|medication because they will prevent your body from fully||
0745|037|H|absorbing this drug.||
0745|038|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0745|039|H|using this medication unless your doctor or pharmacist says you||
0745|040|H|may do so safely. Grapefruit can increase the chance of side||
0745|041|H|effects with this medicine. Ask your doctor or pharmacist for||
0745|042|H|more details.||
0745|043|H|   Since this drug can be absorbed through the skin and lungs and||
0745|044|H|may harm an unborn baby, women who are pregnant or who may become||
0745|045|H|pregnant should not handle this medication or breathe the dust||
0745|046|H|from the tablets.||
0745|047|B|||
0745|048|S|SIDE EFFECTS:  See also Precautions section.||
0745|049|S|   Diarrhea, nausea/vomiting, muscle/joint pain, or headache may||
0745|050|S|occur. If any of these effects last or get worse, tell your||
0745|051|S|doctor or pharmacist promptly.||
0745|052|S|   People using this medication may have serious side effects.||
0745|053|S|However, you have been prescribed this drug because your doctor||
0745|054|S|has judged that the benefit to you is greater than the risk of||
0745|055|S|side effects. Careful monitoring by your doctor may decrease your||
0745|056|S|risk.||
0745|057|S|   Tell your doctor right away if you have any serious side||
0745|058|S|effects, including: dry cough, swelling/pain in the||
0745|059|S|hands/ankles/feet, sudden/unexplained weight gain, shortness of||
0745|060|S|breath, signs of liver disease (such as nausea/vomiting that||
0745|061|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
0745|062|S|eyes/skin, dark urine).||
0745|063|S|   Get medical help right away if you have any very serious side||
0745|064|S|effects, including: vomit that looks like coffee grounds,||
0745|065|S|black/bloody stools, severe dizziness, fainting,||
0745|066|S|fast/slow/irregular heartbeat, chest pain, confusion, weakness on||
0745|067|S|one side of the body.||
0745|068|S|   Dasatinib sometimes causes side effects due to the rapid||
0745|069|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
0745|070|S|risk, your doctor may add a medication and tell you to drink||
0745|071|S|plenty of fluids. Tell your doctor right away if you have||
0745|072|S|symptoms such as: low back/side pain (flank pain), signs of||
0745|073|S|kidney problems (such as painful urination, pink/bloody urine,||
0745|074|S|change in the amount of urine), muscle spasms/weakness.||
0745|075|S|   This medication decreases bone marrow function, an effect that||
0745|076|S|may lead to a low number of blood cells such as red cells, white||
0745|077|S|cells, and platelets. This effect can cause anemia, decrease your||
0745|078|S|body's ability to fight an infection, or cause easy||
0745|079|S|bruising/bleeding. Tell your doctor right away if you develop any||
0745|080|S|of the following symptoms: unusual tiredness, pale skin, signs of||
0745|081|S|infection (such as sore throat that doesn't go away, fever,||
0745|082|S|chills), easy bruising/bleeding.||
0745|083|S|   A very serious allergic reaction to this drug is rare.||
0745|084|S|However, get medical help right away if you notice any symptoms||
0745|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0745|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0745|087|S|breathing.||
0745|088|S|   This is not a complete list of possible side effects. If you||
0745|089|S|notice other effects not listed above, contact your doctor or||
0745|090|S|pharmacist.||
0745|091|S|   In the US -||
0745|092|S|   Call your doctor for medical advice about side effects. You||
0745|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0745|094|S|www.fda.gov/medwatch.||
0745|095|S|   In Canada - Call your doctor for medical advice about side||
0745|096|S|effects. You may report side effects to Health Canada at||
0745|097|S|1-866-234-2345.||
0745|098|B|||
0745|099|P|PRECAUTIONS:  Before taking dasatinib, tell your doctor or||
0745|100|P|pharmacist if you are allergic to it; or if you have any other||
0745|101|P|allergies. This product may contain inactive ingredients (such as||
0745|102|P|lactose), which can cause allergic reactions or other problems.||
0745|103|P|Talk to your pharmacist for more details.||
0745|104|P|   Before using this medication, tell your doctor or pharmacist||
0745|105|P|your medical history, especially of: bleeding problems,||
0745|106|P|current/recent infection, heart problems (such as irregular||
0745|107|P|heartbeat), liver problems (such as hepatitis B).||
0745|108|P|   Dasatinib may cause a condition that affects the heart rhythm||
0745|109|P|(QT prolongation). QT prolongation can rarely cause serious||
0745|110|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0745|111|P|as severe dizziness, fainting) that need medical attention right||
0745|112|P|away.||
0745|113|P|   The risk of QT prolongation may be increased if you have||
0745|114|P|certain medical conditions or are taking other drugs that may||
0745|115|P|cause QT prolongation. Before using dasatinib, tell your doctor||
0745|116|P|or pharmacist of all the drugs you take and if you have any of||
0745|117|P|the following conditions: certain heart problems (heart failure,||
0745|118|P|slow heartbeat, QT prolongation in the EKG), family history of||
0745|119|P|certain heart problems (QT prolongation in the EKG, sudden||
0745|120|P|cardiac death).||
0745|121|P|   Low levels of potassium or magnesium in the blood may also||
0745|122|P|increase your risk of QT prolongation. This risk may increase if||
0745|123|P|you use certain drugs (such as diuretics/"water pills") or if you||
0745|124|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0745|125|P|Talk to your doctor about using dasatinib safely.||
0745|126|P|   Dasatinib can make you more likely to get infections or may||
0745|127|P|make current infections worse. Stay away from anyone who has an||
0745|128|P|infection that may easily spread (such as chickenpox, COVID-19,||
0745|129|P|measles, flu). Talk to your doctor if you have been exposed to an||
0745|130|P|infection or for more details.||
0745|131|P|   Tell your health care professional that you are using||
0745|132|P|dasatinib before having any immunizations/vaccinations. Avoid||
0745|133|P|contact with people who have recently received live vaccines||
0745|134|P|(such as flu vaccine inhaled through the nose).||
0745|135|P|   To lower the chance of getting cut, bruised, or injured, use||
0745|136|P|caution with sharp objects like razors and nail cutters, and||
0745|137|P|avoid activities such as contact sports.||
0745|138|P|   This medication may affect a child's bone growth and||
0745|139|P|development. Consult the doctor or pharmacist for more details.||
0745|140|P|   Older adults may be more sensitive to the side effects of this||
0745|141|P|drug, especially diarrhea, swelling hands/ankles/feet,||
0745|142|P|sudden/unexplained weight gain, unusual tiredness, shortness of||
0745|143|P|breath, and QT prolongation (see above).||
0745|144|P|   Since this drug can be absorbed through the skin and lungs and||
0745|145|P|may harm an unborn baby, women who are pregnant or who may become||
0745|146|P|pregnant should not handle this medication or breathe the dust||
0745|147|P|from the tablets.||
0745|148|P|   Tell your doctor if you are pregnant or plan to become||
0745|149|P|pregnant. You should not become pregnant while using dasatinib.||
0745|150|P|Dasatinib may harm an unborn baby. Your doctor should order a||
0745|151|P|pregnancy test before you start this medication. Men and women||
0745|152|P|using this medication should ask about reliable forms of birth||
0745|153|P|control during treatment and for 30 days after the last dose. If||
0745|154|P|you or your partner becomes pregnant, talk to your doctor right||
0745|155|P|away about the risks and benefits of this medication.||
0745|156|P|   It is unknown if this drug passes into breast milk. Because of||
0745|157|P|the possible risk to the infant, breastfeeding is not recommended||
0745|158|P|while using this drug and for 2 weeks after the last dose.||
0745|159|P|Consult your doctor before breastfeeding.||
0745|160|B|||
0745|161|I|DRUG INTERACTIONS:  See also How to Use section.||
0745|162|I|   Drug interactions may change how your medications work or||
0745|163|I|increase your risk for serious side effects. This document does||
0745|164|I|not contain all possible drug interactions. Keep a list of all||
0745|165|I|the products you use (including prescription/nonprescription||
0745|166|I|drugs and herbal products) and share it with your doctor and||
0745|167|I|pharmacist. Do not start, stop, or change the dosage of any||
0745|168|I|medicines without your doctor's approval.||
0745|169|I|   Some products that may interact with this drug are: other||
0745|170|I|drugs that can cause bleeding/bruising (including antiplatelet||
0745|171|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
0745|172|I|"blood thinners" such as warfarin/dabigatran), drugs that reduce||
0745|173|I|stomach acid (for example, antacids, H2 blockers such as||
0745|174|I|famotidine/ranitidine, proton pump inhibitors such as||
0745|175|I|omeprazole).||
0745|176|I|   Aspirin can increase the risk of bleeding when used with this||
0745|177|I|medication. However, if your doctor has told you to take low-dose||
0745|178|I|aspirin to prevent heart attack or stroke (usually 81-162||
0745|179|I|milligrams a day), you should keep taking the aspirin unless your||
0745|180|I|doctor tells you not to. Ask your doctor or pharmacist for more||
0745|181|I|details.||
0745|182|I|   Other medications can affect the removal of dasatinib from||
0745|183|I|your body, which may affect how dasatinib works. Examples include||
0745|184|I|azole antifungals (such as itraconazole, ketoconazole),||
0745|185|I|dexamethasone, macrolide antibiotics (such as clarithromycin),||
0745|186|I|rifamycins (such as rifampin, rifabutin), St. John's wort,||
0745|187|I|telithromycin, among others.||
0745|188|B|||
0745|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0745|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0745|191|O|poison control center right away. US residents can call||
0745|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0745|193|B|||
0745|194|N|NOTES:  Do not share this medication with others.||
0745|195|N|   Lab and/or medical tests (such as bone growth and development||
0745|196|N|in children, complete blood count, liver function) should be done||
0745|197|N|while you are taking this medication. Keep all medical and lab||
0745|198|N|appointments. Consult your doctor for more details.||
0745|199|B|||
0745|200|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
0745|201|D|next dose at the regular time. Do not double the dose to catch||
0745|202|D|up.||
0745|203|B|||
0745|204|R|STORAGE:  Store at room temperature away from light and moisture.||
0745|205|R|Do not store in the bathroom. Keep all medications away from||
0745|206|R|children and pets.||
0745|207|R|   Do not flush medications down the toilet or pour them into a||
0745|208|R|drain unless instructed to do so. Properly discard this product||
0745|209|R|when it is expired or no longer needed. Consult your pharmacist||
0745|210|R|or local waste disposal company.||
0745|211|B|||
0745|212|M|MEDICAL ALERT:  Your condition can cause complications in a||
0745|213|M|medical emergency. For information about enrolling in MedicAlert,||
0745|214|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0745|215|B|||
0745|216|A|Information last revised July 2024.||
0745|217|A|Copyright(c) 2025 First Databank, Inc.||
0745|218|B|||
0746|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0746|002|Z|does NOT have all possible information about this product. This||
0746|003|Z|information does not assure that this product is safe, effective,||
0746|004|Z|or appropriate for you. This information is not individual||
0746|005|Z|medical advice and does not substitute for the advice of your||
0746|006|Z|health care professional. Always ask your health care||
0746|007|Z|professional for complete information about this product and your||
0746|008|Z|specific health needs.||
0746|009|B|||
0746|010|T|NICOTINE LOZENGE - BUCCAL||
0746|011|F|(NICK-oh-teen)||
0746|012|B|||
0746|013|C|COMMON BRAND NAME(S): Commit, Nicorette||
0746|014|B|||
0746|015|U|USES:  This medication can help you quit smoking by replacing the||
0746|016|U|nicotine in cigarettes. The nicotine in tobacco is an important||
0746|017|U|part of cigarette addiction. When you stop smoking, your nicotine||
0746|018|U|levels drop quickly. This drop can cause withdrawal symptoms such||
0746|019|U|as craving tobacco, nervousness, irritability, headache, weight||
0746|020|U|gain, and difficulty concentrating.||
0746|021|U|   Stopping smoking is hard and your chance of success is best||
0746|022|U|when you are ready and have made a commitment to quit. Nicotine||
0746|023|U|replacement products are part of a total stop-smoking program||
0746|024|U|that includes behavior change, counseling, and support. Smoking||
0746|025|U|causes lung disease, cancer, and heart disease. Stopping smoking||
0746|026|U|is one of the most important things you can do to improve your||
0746|027|U|health and live longer.||
0746|028|B|||
0746|029|H|HOW TO USE:  If you are using the over-the-counter product, read||
0746|030|H|all directions on the product package before using this||
0746|031|H|medication. If your doctor has prescribed this medication, read||
0746|032|H|the Patient Information Leaflet if available from your pharmacist||
0746|033|H|before you start using this product and each time you get a||
0746|034|H|refill. If you have any questions, ask your doctor or pharmacist.||
0746|035|H|   Do not eat or drink anything for 15 minutes before using the||
0746|036|H|lozenge and while the lozenge is in your mouth.||
0746|037|H|   Start this medication on your quit (smoking) day. Suck on a||
0746|038|H|lozenge when you feel the urge to smoke. Place the lozenge in||
0746|039|H|your mouth and allow it to slowly dissolve over 20-30 minutes.||
0746|040|H|You may feel a warm, tingling sensation. Try not to swallow the||
0746|041|H|dissolved medication. Do not chew or swallow the lozenge.||
0746|042|H|Occasionally move the lozenge from one side of your mouth to the||
0746|043|H|other with your tongue.||
0746|044|H|   The best dose for you is the dose that decreases the urge to||
0746|045|H|smoke without side effects from too much nicotine. Your dose will||
0746|046|H|need to be adjusted to your needs, including smoking history and||
0746|047|H|medical condition. During the first 6 weeks, use 1 lozenge every||
0746|048|H|1-2 hours (at least 9 lozenges a day).||
0746|049|H|   Do not use more than 1 lozenge at a time or continuously use 1||
0746|050|H|lozenge right after another. Doing so may increase side effects||
0746|051|H|such as hiccups, heartburn, and nausea. Do not use more than 5||
0746|052|H|lozenges in 6 hours or more than 20 lozenges in a day. You may||
0746|053|H|use this product on a regular schedule as well as at times when||
0746|054|H|you have the urge to smoke.||
0746|055|H|   When you have stopped smoking and you have reached the best||
0746|056|H|dose and schedule for you, continue at that dose. After about 6||
0746|057|H|weeks, start using fewer lozenges each day as directed in the||
0746|058|H|package or by your doctor until you are no longer smoking and no||
0746|059|H|longer need nicotine replacement. It is important to complete the||
0746|060|H|treatment with this medication (12 weeks). If after the treatment||
0746|061|H|period, you still feel the need to use this medication to prevent||
0746|062|H|you from smoking, talk to your doctor.||
0746|063|H|   If you suddenly stop using this medication, you may have||
0746|064|H|withdrawal symptoms (such as tobacco cravings, nervousness,||
0746|065|H|irritability, headache). To help prevent withdrawal, your doctor||
0746|066|H|may lower your dose slowly. Withdrawal is more likely if you have||
0746|067|H|used nicotine for a long time or in high doses. Tell your doctor||
0746|068|H|or pharmacist right away if you have withdrawal.||
0746|069|H|   Some smokers are unsuccessful the first time they try to quit.||
0746|070|H|You may need to stop using this product and try again later. Many||
0746|071|H|people who cannot quit the first time are successful the next||
0746|072|H|time.||
0746|073|B|||
0746|074|S|SIDE EFFECTS:  Mouth sores, hiccups, nausea, sore throat,||
0746|075|S|headache, heartburn, or dizziness may occur. If any of these||
0746|076|S|effects last or get worse, stop using this medication and tell||
0746|077|S|your doctor or pharmacist promptly.||
0746|078|S|   Common nicotine withdrawal symptoms can occur when you stop||
0746|079|S|smoking and include dizziness, anxiety, depression, or trouble||
0746|080|S|sleeping, among others.||
0746|081|S|   If your doctor has directed you to use this medication,||
0746|082|S|remember that your doctor has judged that the benefit to you is||
0746|083|S|greater than the risk of side effects. Many people using this||
0746|084|S|medication do not have serious side effects. Serious side effects||
0746|085|S|are more likely if you continue to smoke while using this||
0746|086|S|product.||
0746|087|S|   Stop using this medication and tell your doctor right away if||
0746|088|S|you have any serious side effects, including: severe dizziness,||
0746|089|S|mental/mood changes (such as irritability, trouble sleeping,||
0746|090|S|vivid dreams), numbness/tingling in hands/feet, swelling||
0746|091|S|hands/ankles/feet.||
0746|092|S|   Stop using this medication and get medical help right away if||
0746|093|S|you have any very serious side effects, including: chest pain,||
0746|094|S|confusion, severe headache, fast/irregular/pounding heartbeat,||
0746|095|S|trouble speaking, weakness on one side of the body.||
0746|096|S|   A very serious allergic reaction to this drug is rare.||
0746|097|S|However, get medical help right away if you notice any symptoms||
0746|098|S|of a serious allergic reaction, including: rash, itching/swelling||
0746|099|S|(especially of the face/tongue/throat), trouble breathing.||
0746|100|S|   This is not a complete list of possible side effects. If you||
0746|101|S|notice other effects not listed above, contact your doctor or||
0746|102|S|pharmacist.||
0746|103|S|   In the US -||
0746|104|S|   Call your doctor for medical advice about side effects. You||
0746|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0746|106|S|www.fda.gov/medwatch.||
0746|107|S|   In Canada - Call your doctor for medical advice about side||
0746|108|S|effects. You may report side effects to Health Canada at||
0746|109|S|1-866-234-2345.||
0746|110|B|||
0746|111|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0746|112|P|pharmacist if you are allergic to it; or if you have any other||
0746|113|P|allergies. This product may contain inactive ingredients (such as||
0746|114|P|soya found in some brands), which can cause allergic reactions or||
0746|115|P|other problems. Talk to your pharmacist for more details.||
0746|116|P|   Before using this medication, tell your doctor or pharmacist||
0746|117|P|your medical history, especially of: blood vessel disease (such||
0746|118|P|as Raynaud's disease, stroke), diabetes, heart disease (such as||
0746|119|P|chest pain, heart attack, irregular heartbeat), high blood||
0746|120|P|pressure, liver disease, kidney disease, esophagus problems (such||
0746|121|P|as esophagitis), stomach/intestinal sores (peptic ulcers), a||
0746|122|P|certain adrenal gland tumor (pheochromocytoma), overactive||
0746|123|P|thyroid (hyperthyroidism), seizures.||
0746|124|P|   This medication may contain aspartame. If you have||
0746|125|P|phenylketonuria (PKU) or any other condition that requires you to||
0746|126|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
0746|127|P|doctor or pharmacist about using this medication safely.||
0746|128|P|   Before having surgery, tell your doctor or dentist about all||
0746|129|P|the products you use (including prescription drugs,||
0746|130|P|nonprescription drugs, and herbal products).||
0746|131|P|   Nicotine and smoking may harm an unborn baby. If you are||
0746|132|P|pregnant, try to stop smoking without using a nicotine||
0746|133|P|replacement product if possible. During pregnancy, this||
0746|134|P|medication should be used only when clearly needed. Discuss the||
0746|135|P|risks and benefits with your doctor.||
0746|136|P|   Nicotine from smoking and from this medication passes into||
0746|137|P|breast milk and could have undesirable effects on a nursing||
0746|138|P|infant. Smoking near an infant can also harm the infant. Consult||
0746|139|P|your doctor before breastfeeding.||
0746|140|B|||
0746|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0746|142|I|medications work or increase your risk for serious side effects.||
0746|143|I|This document does not contain all possible drug interactions.||
0746|144|I|Keep a list of all the products you use (including||
0746|145|I|prescription/nonprescription drugs and herbal products) and share||
0746|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
0746|147|I|the dosage of any medicines without your doctor's approval.||
0746|148|I|   Stopping smoking can change the way the liver removes certain||
0746|149|I|drugs from the body (including acetaminophen, caffeine, insulin,||
0746|150|I|oxazepam, pentazocine, propoxyphene, propranolol, theophylline,||
0746|151|I|tricyclic antidepressants such as amitriptyline/imipramine,||
0746|152|I|"water pills"/diuretics such as furosemide). Tell all your||
0746|153|I|doctors and pharmacists that you are quitting smoking.||
0746|154|B|||
0746|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0746|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0746|157|O|poison control center right away. US residents can call||
0746|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0746|159|O|Symptoms of overdose may include: confusion, drooling, seizure,||
0746|160|O|slow/shallow breathing, hearing problems.||
0746|161|B|||
0746|162|N|NOTES:  Do not share this medication with others.||
0746|163|B|||
0746|164|D|MISSED DOSE:  If you are using this on a regular schedule and you||
0746|165|D|miss a dose, use it as soon as you remember. If it is near the||
0746|166|D|time of the next dose, skip the missed dose. Use your next dose||
0746|167|D|at the regular time. Do not double the dose to catch up.||
0746|168|B|||
0746|169|R|STORAGE:  Store at room temperature away from light and moisture.||
0746|170|R|Do not store in the bathroom. Wrap any partly used lozenge in||
0746|171|R|paper and discard in the trash away from children and pets. Keep||
0746|172|R|all medications away from children and pets.||
0746|173|R|   Do not flush medications down the toilet or pour them into a||
0746|174|R|drain unless instructed to do so. Properly discard this product||
0746|175|R|when it is expired or no longer needed. Consult your pharmacist||
0746|176|R|or local waste disposal company.||
0746|177|B|||
0746|178|A|Information last revised August 2024.||
0746|179|A|Copyright(c) 2025 First Databank, Inc.||
0746|180|B|||
0747|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0747|002|Z|does NOT have all possible information about this product. This||
0747|003|Z|information does not assure that this product is safe, effective,||
0747|004|Z|or appropriate for you. This information is not individual||
0747|005|Z|medical advice and does not substitute for the advice of your||
0747|006|Z|health care professional. Always ask your health care||
0747|007|Z|professional for complete information about this product and your||
0747|008|Z|specific health needs.||
0747|009|B|||
0747|010|T|DARUNAVIR - ORAL||
0747|011|F|(dar-YOU-nah-veer)||
0747|012|B|||
0747|013|C|COMMON BRAND NAME(S): Prezista||
0747|014|B|||
0747|015|U|USES:  This drug is used with other HIV medications to help||
0747|016|U|control HIV infection. It helps to decrease the amount of HIV in||
0747|017|U|your body so your immune system can work better. This lowers your||
0747|018|U|chance of getting HIV complications (such as new infections,||
0747|019|U|cancer) and improves your quality of life.||
0747|020|U|   Darunavir belongs to a class of drugs known as protease||
0747|021|U|inhibitors. Darunavir must be given with certain other||
0747|022|U|medications (such as cobicistat, ritonavir) to increase ("boost")||
0747|023|U|the levels of darunavir. This helps darunavir work better.||
0747|024|U|   Darunavir is not a cure for HIV infection. To decrease your||
0747|025|U|risk of spreading HIV disease to others, continue to take all HIV||
0747|026|U|medications exactly as prescribed by your doctor. Use an||
0747|027|U|effective barrier method (latex or polyurethane condoms/dental||
0747|028|U|dams) during sexual activity as directed by your doctor. Do not||
0747|029|U|share personal items (such as needles/syringes, toothbrushes, and||
0747|030|U|razors) that may have contacted blood or other body fluids.||
0747|031|U|Consult your doctor or pharmacist for more details.||
0747|032|U|   This medication is not recommended for use in children younger||
0747|033|U|than 3 years due to the increased risk of serious side effects.||
0747|034|B|||
0747|035|V|OTHER USES:  This section contains uses of this drug that are not||
0747|036|V|listed in the approved professional labeling for the drug but||
0747|037|V|that may be prescribed by your health care professional. Use this||
0747|038|V|drug for a condition that is listed in this section only if it||
0747|039|V|has been so prescribed by your health care professional.||
0747|040|V|   This product may also be used to lessen the risk of HIV||
0747|041|V|infection after contact with the virus (for example, due to a||
0747|042|V|needle stick). Ask your doctor for more details.||
0747|043|B|||
0747|044|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0747|045|H|from your pharmacist before you start taking darunavir and each||
0747|046|H|time you get a refill. If you are using the liquid form of this||
0747|047|H|medication, carefully read the Instructions for Use provided with||
0747|048|H|the medication. If you have any questions, ask your doctor or||
0747|049|H|pharmacist.||
0747|050|H|   Take this medication by mouth with food as directed by your||
0747|051|H|doctor. Darunavir must be taken at the same time as certain other||
0747|052|H|medications, usually once or twice a day. (See also Uses||
0747|053|H|section.) If you have trouble swallowing the tablets, ask your||
0747|054|H|doctor if you should use the liquid form.||
0747|055|H|   If you are using the liquid form of this medication, shake the||
0747|056|H|bottle well before each dose. Carefully measure the dose using a||
0747|057|H|special measuring device/spoon. Do not use a household spoon||
0747|058|H|because you may not get the correct dose.||
0747|059|H|   The dosage is based on your age, lab tests, medical condition,||
0747|060|H|and response to treatment. Children's dosage is also based on||
0747|061|H|weight.||
0747|062|H|   It is very important to keep taking this medication (and other||
0747|063|H|HIV medications) exactly as prescribed by your doctor.||
0747|064|H|   For the best effect, take this medication at evenly spaced||
0747|065|H|times. To help you remember, take this medication at the same||
0747|066|H|time(s) every day.||
0747|067|H|   Do not take more or less of this drug than prescribed or stop||
0747|068|H|taking it (or other HIV medicines) even for a short time unless||
0747|069|H|directed to do so by your doctor. Skipping or changing your dose||
0747|070|H|without approval from your doctor may cause the amount of virus||
0747|071|H|to increase, make the infection more difficult to treat||
0747|072|H|(resistant), or worsen side effects.||
0747|073|B|||
0747|074|S|SIDE EFFECTS:  Since darunavir is always taken with other HIV||
0747|075|S|medications, it may be difficult to tell whether darunavir is||
0747|076|S|causing certain side effects. However, darunavir is known to||
0747|077|S|cause diarrhea, nausea, vomiting, stomach pain, and headache. If||
0747|078|S|any of these effects last or get worse, tell your doctor or||
0747|079|S|pharmacist promptly.||
0747|080|S|   Remember that this medication has been prescribed because your||
0747|081|S|doctor has judged that the benefit to you is greater than the||
0747|082|S|risk of side effects. Many people using this medication do not||
0747|083|S|have serious side effects.||
0747|084|S|   As your immune system gets stronger, it can begin to fight off||
0747|085|S|infections you already had, possibly causing disease symptoms to||
0747|086|S|come back. You could also have symptoms if your immune system||
0747|087|S|becomes overactive. This reaction may happen at any time (soon||
0747|088|S|after starting HIV treatment or many months later). Tell your||
0747|089|S|doctor right away if you have any serious symptoms, including:||
0747|090|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
0747|091|S|that doesn't go away, headaches that are severe or don't go away,||
0747|092|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
0747|093|S|changes, signs of infection (such as sore throat that doesn't go||
0747|094|S|away, fever, chills, non-healing skin sores), signs of an||
0747|095|S|overactive thyroid (such as irritability, nervousness, heat||
0747|096|S|intolerance, fast/pounding/irregular heartbeat).||
0747|097|S|   This medication may rarely make your blood sugar rise, which||
0747|098|S|can cause or worsen diabetes. Tell your doctor right away if you||
0747|099|S|have symptoms of high blood sugar such as increased||
0747|100|S|thirst/urination. If you already have diabetes, check your blood||
0747|101|S|sugar regularly as directed and share the results with your||
0747|102|S|doctor. Your doctor may need to adjust your diabetes medication,||
0747|103|S|exercise program, or diet.||
0747|104|S|   Get medical help right away if you have any very serious side||
0747|105|S|effects, including: symptoms of a heart attack (such as||
0747|106|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
0747|107|S|easy bruising/bleeding.||
0747|108|S|   This drug may rarely cause serious (possibly fatal) liver||
0747|109|S|problems. Get medical help right away if you have any symptoms of||
0747|110|S|liver damage, including: nausea/vomiting that doesn't stop,||
0747|111|S|severe stomach/abdominal pain, dark urine, yellowing eyes/skin.||
0747|112|S|   Changes in body fat may occur while you are taking this||
0747|113|S|medication (such as increased fat in the upper back and stomach||
0747|114|S|areas, decreased fat in the arms and legs). The cause and||
0747|115|S|long-term effects of these changes are unknown. Discuss the risks||
0747|116|S|and benefits of treatment with your doctor, as well as the||
0747|117|S|possible use of exercise to reduce this side effect.||
0747|118|S|   A very serious allergic reaction to this drug is rare.||
0747|119|S|However, get medical help right away if you notice any symptoms||
0747|120|S|of a serious allergic reaction, including: swollen lymph nodes,||
0747|121|S|rash, itching/swelling (especially of the face/tongue/throat),||
0747|122|S|severe dizziness, trouble breathing.||
0747|123|S|   Darunavir can commonly cause a rash that is usually not||
0747|124|S|serious. However, you may not be able to tell it apart from a||
0747|125|S|rare rash that could be a sign of a severe reaction. Get medical||
0747|126|S|help right away if you develop any rash, especially with symptoms||
0747|127|S|such as fever, tiredness, muscle/joint pain, blisters, mouth||
0747|128|S|sores, or red/swollen eyes.||
0747|129|S|   This is not a complete list of possible side effects. If you||
0747|130|S|notice other effects not listed above, contact your doctor or||
0747|131|S|pharmacist.||
0747|132|S|   In the US -||
0747|133|S|   Call your doctor for medical advice about side effects. You||
0747|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0747|135|S|www.fda.gov/medwatch.||
0747|136|S|   In Canada - Call your doctor for medical advice about side||
0747|137|S|effects. You may report side effects to Health Canada at||
0747|138|S|1-866-234-2345.||
0747|139|B|||
0747|140|P|PRECAUTIONS:  Before taking darunavir, tell your doctor or||
0747|141|P|pharmacist if you are allergic to it; or if you have any other||
0747|142|P|allergies. This product may contain inactive ingredients, which||
0747|143|P|can cause allergic reactions or other problems. Talk to your||
0747|144|P|pharmacist for more details.||
0747|145|P|   Before using this medication, tell your doctor or pharmacist||
0747|146|P|your medical history, especially of: liver problems (such as||
0747|147|P|hepatitis B or C), diabetes, a certain bleeding problem||
0747|148|P|(hemophilia), lipid problems (high cholesterol or||
0747|149|P|triglycerides/fats), heart problems (coronary artery disease,||
0747|150|P|heart attack).||
0747|151|P|   Before having surgery, tell your doctor or dentist about all||
0747|152|P|the products you use (including prescription drugs,||
0747|153|P|nonprescription drugs, and herbal products).||
0747|154|P|   Tell your doctor if you are pregnant before using this||
0747|155|P|medication. Treatment can lower the risk of passing HIV infection||
0747|156|P|to your baby. Discuss the risks and benefits with your doctor.||
0747|157|P|   This medication passes into breast milk. Because breast milk||
0747|158|P|may transmit HIV, consult your doctor before breastfeeding.||
0747|159|B|||
0747|160|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0747|161|I|medications work or increase your risk for serious side effects.||
0747|162|I|This document does not contain all possible drug interactions.||
0747|163|I|Keep a list of all the products you use (including||
0747|164|I|prescription/nonprescription drugs and herbal products) and share||
0747|165|I|it with your doctor and pharmacist. Do not start, stop, or change||
0747|166|I|the dosage of any medicines without your doctor's approval.||
0747|167|I|   Some of the products that may interact with this drug include:||
0747|168|I|orlistat, certain drugs used to treat seizures (such as||
0747|169|I|carbamazepine, phenytoin, primidone), barbiturates (such as||
0747|170|I|phenobarbital, secobarbital), a certain combination HIV||
0747|171|I|medication (elvitegravir/cobicistat/emtricitabine/tenofovir).||
0747|172|I|   Darunavir can slow down the removal of other drugs from your||
0747|173|I|body, which may affect how they work. Examples of affected drugs||
0747|174|I|include certain alpha blockers (such as alfuzosin, tamsulosin),||
0747|175|I|certain benzodiazepines (midazolam, triazolam), bosutinib,||
0747|176|I|dronedarone, ergot alkaloids (such as dihydroergotamine,||
0747|177|I|ergotamine), certain drugs to treat erectile dysfunction-ED or||
0747|178|I|pulmonary hypertension (such as avanafil, sildenafil),||
0747|179|I|lomitapide, pimozide, ranolazine, rivaroxaban, salmeterol,||
0747|180|I|certain "statin" cholesterol drugs (such as lovastatin,||
0747|181|I|simvastatin), tolvaptan, among others.||
0747|182|I|   Other medications can affect the removal of darunavir from||
0747|183|I|your body, which may affect how darunavir works. Examples include||
0747|184|I|apalutamide, garlic supplements, certain rifamycins (rifampin,||
0747|185|I|rifapentine), St. John's Wort, among others.||
0747|186|I|   This medication may decrease the effectiveness of hormonal||
0747|187|I|birth control such as pills, patch, or ring. This could cause||
0747|188|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0747|189|I|use reliable backup birth control methods while using this||
0747|190|I|medication. Also tell your doctor if you have any new spotting or||
0747|191|I|breakthrough bleeding, because these may be signs that your birth||
0747|192|I|control is not working well.||
0747|193|I|   Do not take this medication with other products that contain||
0747|194|I|darunavir.||
0747|195|B|||
0747|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0747|197|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0747|198|O|poison control center right away. US residents can call||
0747|199|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0747|200|B|||
0747|201|N|NOTES:  Do not share this medication with others.||
0747|202|N|   Lab and/or medical tests (such as liver function, viral load,||
0747|203|N|T-cell counts, triglycerides/cholesterol, blood sugar) should be||
0747|204|N|done while you are taking this medication. Keep all medical and||
0747|205|N|lab appointments. Consult your doctor for more details.||
0747|206|B|||
0747|207|D|MISSED DOSE:  If you are taking this medication 2 times daily and||
0747|208|D|you miss a dose, take it as soon as you remember. If it is less||
0747|209|D|than 6 hours before the next dose, skip the missed dose. Take||
0747|210|D|your next dose at the regular time. Do not double the dose to||
0747|211|D|catch up.||
0747|212|D|   If you are taking this medication once daily and you miss a||
0747|213|D|dose, take it as soon as you remember. If it is less than 12||
0747|214|D|hours before the next dose, skip the missed dose. Take your next||
0747|215|D|dose at the regular time. Do not double the dose to catch up.||
0747|216|B|||
0747|217|R|STORAGE:  Store at room temperature away from light and moisture.||
0747|218|R|Do not store in the bathroom. Keep the liquid form of this||
0747|219|R|medication in the original container. Do not refrigerate or||
0747|220|R|freeze the liquid form. Keep all medications away from children||
0747|221|R|and pets.||
0747|222|R|   Do not flush medications down the toilet or pour them into a||
0747|223|R|drain unless instructed to do so. Properly discard this product||
0747|224|R|when it is expired or no longer needed. Consult your pharmacist||
0747|225|R|or local waste disposal company.||
0747|226|B|||
0747|227|A|Information last revised April 2025.||
0747|228|A|Copyright(c) 2025 First Databank, Inc.||
0747|229|B|||
0749|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0749|002|Z|does NOT have all possible information about this product. This||
0749|003|Z|information does not assure that this product is safe, effective,||
0749|004|Z|or appropriate for you. This information is not individual||
0749|005|Z|medical advice and does not substitute for the advice of your||
0749|006|Z|health care professional. Always ask your health care||
0749|007|Z|professional for complete information about this product and your||
0749|008|Z|specific health needs.||
0749|009|B|||
0749|010|T|CALCIPOTRIENE SCALP SOLUTION - TOPICAL||
0749|011|F|(KAL-si-poe-TRYE-een)||
0749|012|B|||
0749|013|C|COMMON BRAND NAME(S): Dovonex||
0749|014|B|||
0749|015|U|USES:  This medication is used to treat long-term psoriasis of||
0749|016|U|the scalp. Calcipotriene is a form of vitamin D. It works by||
0749|017|U|slowing down the growth of skin cells.||
0749|018|B|||
0749|019|H|HOW TO USE:  Use this medication on the skin only. Comb the hair||
0749|020|H|first to remove any scaly flakes. Apply the medication only to||
0749|021|H|the affected areas of the scalp and gently rub in as directed by||
0749|022|H|your doctor, usually twice daily. Take care not to let any of the||
0749|023|H|solution spread onto the forehead or any unaffected area. Wash||
0749|024|H|your hands after using. Do not apply the medication on the face,||
0749|025|H|in the eyes, nose, or mouth, or inside the vagina. If you do get||
0749|026|H|the medication in those areas, flush with plenty of water.||
0749|027|H|   Do not apply more often or use longer than prescribed. This||
0749|028|H|may increase the risk of side effects.||
0749|029|H|   Use this medication regularly to get the most benefit from it.||
0749|030|H|To help you remember, use it at the same times each day.||
0749|031|H|   Tell your doctor if your condition does not get better or if||
0749|032|H|it gets worse. You should usually begin to see an improvement in||
0749|033|H|your skin condition after 2 weeks of treatment.||
0749|034|B|||
0749|035|S|SIDE EFFECTS:  Burning, stinging, tingling, rash, dry skin, or||
0749|036|S|irritation at the application site may occur. If any of these||
0749|037|S|effects last or get worse, tell your doctor or pharmacist||
0749|038|S|promptly.||
0749|039|S|   Remember that this medication has been prescribed because your||
0749|040|S|doctor has judged that the benefit to you is greater than the||
0749|041|S|risk of side effects. Many people using this medication do not||
0749|042|S|have serious side effects.||
0749|043|S|   Tell your doctor right away if you have any serious side||
0749|044|S|effects, including: skin thinning/discoloration, stretch marks,||
0749|045|S|small red bumps on the skin (folliculitis), unusual tiredness,||
0749|046|S|mental/mood changes, unexplained constipation.||
0749|047|S|   A very serious allergic reaction to this drug is rare.||
0749|048|S|However, get medical help right away if you notice any symptoms||
0749|049|S|of a serious allergic reaction, including: rash, itching/swelling||
0749|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0749|051|S|breathing.||
0749|052|S|   This is not a complete list of possible side effects. If you||
0749|053|S|notice other effects not listed above, contact your doctor or||
0749|054|S|pharmacist.||
0749|055|S|   In the US -||
0749|056|S|   Call your doctor for medical advice about side effects. You||
0749|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0749|058|S|www.fda.gov/medwatch.||
0749|059|S|   In Canada - Call your doctor for medical advice about side||
0749|060|S|effects. You may report side effects to Health Canada at||
0749|061|S|1-866-234-2345.||
0749|062|B|||
0749|063|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0749|064|P|pharmacist if you are allergic to it; or if you have any other||
0749|065|P|allergies. This product may contain inactive ingredients, which||
0749|066|P|can cause allergic reactions or other problems. Talk to your||
0749|067|P|pharmacist for more details.||
0749|068|P|   Before using this medication, tell your doctor or pharmacist||
0749|069|P|your medical history, especially of: high calcium/vitamin D||
0749|070|P|levels (hypercalcemia/hypervitaminosis D).||
0749|071|P|   This medication may make you more sensitive to the sun. Limit||
0749|072|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0749|073|P|sunscreen and wear protective clothing when outdoors. Tell your||
0749|074|P|doctor right away if you get sunburned or have skin||
0749|075|P|blisters/redness. Your doctor may direct you to limit or avoid||
0749|076|P|phototherapy while you use this product. Ask your doctor for||
0749|077|P|details.||
0749|078|P|   During pregnancy, this medication should be used only when||
0749|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
0749|080|P|   It is unknown if this drug passes into breast milk. Consult||
0749|081|P|your doctor before breastfeeding.||
0749|082|B|||
0749|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0749|084|I|medications work or increase your risk for serious side effects.||
0749|085|I|This document does not contain all possible drug interactions.||
0749|086|I|Keep a list of all the products you use (including||
0749|087|I|prescription/nonprescription drugs and herbal products) and share||
0749|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
0749|089|I|the dosage of any medicines without your doctor's approval.||
0749|090|I|   Some products that may interact with this drug are: other||
0749|091|I|products containing vitamin D.||
0749|092|B|||
0749|093|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0749|094|O|has overdosed and has serious symptoms such as passing out or||
0749|095|O|trouble breathing, call 911. Otherwise, call a poison control||
0749|096|O|center right away. US residents can call 1-800-222-1222. Canada||
0749|097|O|residents can call 1-844-764-7669.||
0749|098|B|||
0749|099|N|NOTES:  Do not share this medication with others.||
0749|100|N|   Lab and/or medical tests (such as calcium levels) may be done||
0749|101|N|while you are using this medication. Keep all medical and lab||
0749|102|N|appointments. Consult your doctor for more details.||
0749|103|N|   This medication has been prescribed for your current condition||
0749|104|N|only. Do not use it later for another skin condition unless told||
0749|105|N|to do so by your doctor. A different medication may be necessary||
0749|106|N|in that case.||
0749|107|B|||
0749|108|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0749|109|D|If it is near the time of the next dose, skip the missed dose.||
0749|110|D|Use your next dose at the regular time. Do not double the dose to||
0749|111|D|catch up.||
0749|112|B|||
0749|113|R|STORAGE:  Store at room temperature away from sunlight or open||
0749|114|R|flames. Do not freeze. Keep all medications away from children||
0749|115|R|and pets.||
0749|116|R|   Do not flush medications down the toilet or pour them into a||
0749|117|R|drain unless instructed to do so. Properly discard this product||
0749|118|R|when it is expired or no longer needed. Consult your pharmacist||
0749|119|R|or local waste disposal company.||
0749|120|B|||
0749|121|A|Information last revised November 2024.||
0749|122|A|Copyright(c) 2025 First Databank, Inc.||
0749|123|B|||
0750|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0750|002|Z|does NOT have all possible information about this product. This||
0750|003|Z|information does not assure that this product is safe, effective,||
0750|004|Z|or appropriate for you. This information is not individual||
0750|005|Z|medical advice and does not substitute for the advice of your||
0750|006|Z|health care professional. Always ask your health care||
0750|007|Z|professional for complete information about this product and your||
0750|008|Z|specific health needs.||
0750|009|B|||
0750|010|T|OXYMORPHONE - ORAL||
0750|011|F|(OX-i-MOR-fone)||
0750|012|B|||
0750|013|C|COMMON BRAND NAME(S): Opana||
0750|014|B|||
0750|015|W|WARNING:  Oxymorphone has a risk for abuse and addiction, which||
0750|016|W|can lead to overdose and death. Oxymorphone may also cause||
0750|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
0750|018|W|your doctor should have you take the smallest dose of oxymorphone||
0750|019|W|that works, and take it for the shortest possible time. See also||
0750|020|W|How to Use section for more information about addiction.||
0750|021|W|   Ask your doctor or pharmacist if you should have medication||
0750|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0750|023|W|Teach your family or household members about the signs of an||
0750|024|W|opioid overdose and how to treat it.||
0750|025|W|   The risk for severe breathing problems is higher when you||
0750|026|W|start this medication and after a dose increase, or if you take||
0750|027|W|the wrong dose/strength. Taking this medication with alcohol or||
0750|028|W|other drugs that can cause drowsiness or breathing problems may||
0750|029|W|cause very serious side effects, including death. Be sure you||
0750|030|W|know how to take oxymorphone and what other drugs you should||
0750|031|W|avoid taking with it. See also Drug Interactions section. Get||
0750|032|W|medical help right away if any of these very serious side effects||
0750|033|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
0750|034|W|drowsiness/dizziness, difficulty waking up.||
0750|035|W|   Do not drink alcohol or take any products that contain alcohol||
0750|036|W|while taking this medication. This may cause an increase of the||
0750|037|W|medication in your body that may be fatal.||
0750|038|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0750|039|W|or abuse. If someone accidentally swallows this drug, get medical||
0750|040|W|help right away.||
0750|041|W|   Before using this medication, women of childbearing age should||
0750|042|W|talk with their doctor(s) about the risks and benefits. Tell your||
0750|043|W|doctor if you are pregnant or if you plan to become pregnant.||
0750|044|W|During pregnancy, this medication should be used only when||
0750|045|W|clearly needed. It may slightly increase the risk of birth||
0750|046|W|defects if used during the first two months of pregnancy. Also,||
0750|047|W|using it for a long time or in high doses near the expected||
0750|048|W|delivery date may harm the unborn baby. To lessen the risk, take||
0750|049|W|the smallest effective dose for the shortest possible time.||
0750|050|W|Babies born to mothers who use this drug for a long time may||
0750|051|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0750|052|W|doctor right away if you notice any symptoms in your newborn baby||
0750|053|W|such as crying that doesn't stop, slow/shallow breathing,||
0750|054|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0750|055|W|difficulty gaining weight.||
0750|056|B|||
0750|057|U|USES:  Oxymorphone is used to help relieve moderate to severe||
0750|058|U|pain. It belongs to a class of drugs known as opioid analgesics.||
0750|059|U|It works in the brain to change how your body feels and responds||
0750|060|U|to pain.||
0750|061|B|||
0750|062|H|HOW TO USE:  Read the Medication Guide provided by your||
0750|063|H|pharmacist before you start taking oxymorphone and each time you||
0750|064|H|get a refill. If you have any questions, ask your doctor or||
0750|065|H|pharmacist.||
0750|066|H|   Take this medication by mouth without food (at least 1 hour||
0750|067|H|before or 2 hours after eating) as directed by your doctor,||
0750|068|H|usually every 4 to 6 hours. If you have nausea, ask your doctor||
0750|069|H|or pharmacist about ways to decrease nausea (such as lying down||
0750|070|H|for 1 to 2 hours with as little head movement as possible).||
0750|071|H|   The dosage is based on your medical condition and response to||
0750|072|H|treatment. Do not increase your dose or use this drug more often||
0750|073|H|or for longer than prescribed because your risk of side effects||
0750|074|H|may increase. Properly stop the medication when so directed.||
0750|075|H|   Pain medications work best if they are used as the first signs||
0750|076|H|of pain occur. If you wait until the pain has worsened, the||
0750|077|H|medication may not work as well.||
0750|078|H|   If you have ongoing pain (such as due to cancer), your doctor||
0750|079|H|may direct you to also take long-acting opioid medications. In||
0750|080|H|that case, this medication might be used for sudden||
0750|081|H|(breakthrough) pain only as needed. Other pain relievers (such as||
0750|082|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
0750|083|H|or pharmacist about using oxymorphone safely with other drugs.||
0750|084|H|   Suddenly stopping this medication may cause withdrawal,||
0750|085|H|especially if you have used it for a long time or in high doses.||
0750|086|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0750|087|H|Tell your doctor or pharmacist right away if you have any||
0750|088|H|withdrawal symptoms such as restlessness, mental/mood changes||
0750|089|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0750|090|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0750|091|H|aches, or sudden changes in behavior.||
0750|092|H|   When this medication is used for a long time, it may not work||
0750|093|H|as well. Talk with your doctor if this medication stops working||
0750|094|H|well.||
0750|095|H|   Though it helps many people, this medication may sometimes||
0750|096|H|cause addiction. This risk may be higher if you have a||
0750|097|H|mental/mood disorder or a substance use disorder (such as overuse||
0750|098|H|of or addiction to drugs/alcohol). Take this medication exactly||
0750|099|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0750|100|H|pharmacist for more details.||
0750|101|H|   Tell your doctor if your pain does not get better or if it||
0750|102|H|gets worse, or if you have any new pain.||
0750|103|B|||
0750|104|S|SIDE EFFECTS:  See also Warning section.||
0750|105|S|   Nausea, vomiting, fever, constipation, increased sweating,||
0750|106|S|lightheadedness, dizziness, or drowsiness may occur. If any of||
0750|107|S|these effects last or get worse, tell your doctor or pharmacist||
0750|108|S|promptly.||
0750|109|S|   To prevent constipation, eat dietary fiber, drink enough||
0750|110|S|water, and exercise. You may also need to take a laxative. Ask||
0750|111|S|your pharmacist which type of laxative is right for you.||
0750|112|S|   To reduce the risk of dizziness and lightheadedness, get up||
0750|113|S|slowly when rising from a sitting or lying position.||
0750|114|S|   Remember that this medication has been prescribed because your||
0750|115|S|doctor has judged that the benefit to you is greater than the||
0750|116|S|risk of side effects. Many people using this medication do not||
0750|117|S|have serious side effects.||
0750|118|S|   Tell your doctor right away if you have any serious side||
0750|119|S|effects, including: interrupted breathing during sleep (sleep||
0750|120|S|apnea), mental/mood changes (such as agitation, confusion,||
0750|121|S|hallucinations), stomach/abdominal pain, vision changes,||
0750|122|S|slow/fast heartbeat, difficulty urinating, signs of your adrenal||
0750|123|S|glands not working well (such as loss of appetite, unusual||
0750|124|S|tiredness, weight loss), trouble swallowing.||
0750|125|S|   Get medical help right away if you have any very serious side||
0750|126|S|effects, including: slow/shallow breathing, fainting, seizure,||
0750|127|S|severe drowsiness/difficulty waking up.||
0750|128|S|   A very serious allergic reaction to this drug is rare.||
0750|129|S|However, get medical help right away if you notice any symptoms||
0750|130|S|of a serious allergic reaction, including: rash, itching/swelling||
0750|131|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0750|132|S|breathing.||
0750|133|S|   This is not a complete list of possible side effects. If you||
0750|134|S|notice other effects not listed above, contact your doctor or||
0750|135|S|pharmacist.||
0750|136|S|   In the US -||
0750|137|S|   Call your doctor for medical advice about side effects. You||
0750|138|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0750|139|S|www.fda.gov/medwatch.||
0750|140|S|   In Canada - Call your doctor for medical advice about side||
0750|141|S|effects. You may report side effects to Health Canada at||
0750|142|S|1-866-234-2345.||
0750|143|B|||
0750|144|P|PRECAUTIONS:  Before taking oxymorphone, tell your doctor or||
0750|145|P|pharmacist if you are allergic to it; or to other opioid pain||
0750|146|P|medications (such as codeine, morphine, oxycodone); or if you||
0750|147|P|have any other allergies. This product may contain inactive||
0750|148|P|ingredients, which can cause allergic reactions or other||
0750|149|P|problems. Talk to your pharmacist for more details.||
0750|150|P|   Before using this medication, tell your doctor or pharmacist||
0750|151|P|your medical history, especially of: brain disorders (such as||
0750|152|P|head injury, tumor, seizures), breathing problems (such as||
0750|153|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0750|154|P|gallbladder disease, kidney disease, liver disease, mental/mood||
0750|155|P|disorders (such as confusion, depression, thoughts of suicide),||
0750|156|P|personal or family history of a substance use disorder (such as||
0750|157|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
0750|158|P|problems (such as blockage, constipation, diarrhea due to||
0750|159|P|infection, paralytic ileus), disease of the pancreas||
0750|160|P|(pancreatitis), difficulty urinating (such as due to enlarged||
0750|161|P|prostate).||
0750|162|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0750|163|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0750|164|P|machinery, or do anything that needs alertness until you can do||
0750|165|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0750|166|P|are using marijuana (cannabis).||
0750|167|P|   Before having surgery, tell your doctor or dentist about all||
0750|168|P|the products you use (including prescription drugs,||
0750|169|P|nonprescription drugs, and herbal products).||
0750|170|P|   Older adults may be more sensitive to the side effects of this||
0750|171|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
0750|172|P|breathing.||
0750|173|P|   During pregnancy, this medication should be used only when||
0750|174|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0750|175|P|benefits with your doctor. (See also Warning section.)||
0750|176|P|   It is unknown if this drug passes into breast milk. However,||
0750|177|P|similar drugs pass into breast milk and may have undesirable||
0750|178|P|effects on a nursing infant. Tell the doctor right away if your||
0750|179|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0750|180|P|breathing. Consult your doctor before breastfeeding.||
0750|181|B|||
0750|182|I|DRUG INTERACTIONS:  See also Warning section.||
0750|183|I|   Drug interactions may change how your medications work or||
0750|184|I|increase your risk for serious side effects. This document does||
0750|185|I|not contain all possible drug interactions. Keep a list of all||
0750|186|I|the products you use (including prescription/nonprescription||
0750|187|I|drugs and herbal products) and share it with your doctor and||
0750|188|I|pharmacist. Do not start, stop, or change the dosage of any||
0750|189|I|medicines without your doctor's approval.||
0750|190|I|   Some products that may interact with this drug include:||
0750|191|I|certain pain medications (mixed opioid agonist-antagonists such||
0750|192|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0750|193|I|samidorphan.||
0750|194|I|   The risk of serious side effects (such as slow/shallow||
0750|195|I|breathing, severe drowsiness/dizziness) may be increased if this||
0750|196|I|medication is taken with other products that may also cause||
0750|197|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0750|198|I|if you are taking other products such as other opioid pain or||
0750|199|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0750|200|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0750|201|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0750|202|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0750|203|I|cetirizine, diphenhydramine).||
0750|204|I|   Check the labels on all your medicines (such as allergy or||
0750|205|I|cough-and-cold products) because they may contain ingredients||
0750|206|I|that cause drowsiness. Ask your pharmacist about using those||
0750|207|I|products safely.||
0750|208|I|   This medication may interfere with certain lab tests (such as||
0750|209|I|amylase/lipase levels), possibly causing false test results. Make||
0750|210|I|sure lab personnel and all your doctors know you use this drug.||
0750|211|B|||
0750|212|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0750|213|O|as passing out or trouble breathing, give them naloxone or||
0750|214|O|nalmefene if available, then call 911. If the person is awake and||
0750|215|O|has no symptoms, call a poison control center right away. US||
0750|216|O|residents can call 1-800-222-1222. Canada residents can call||
0750|217|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0750|218|O|breathing, slow heartbeat, coma.||
0750|219|B|||
0750|220|N|NOTES:  Do not share this medication with others. Sharing it is||
0750|221|N|against the law.||
0750|222|N|   This medication has been prescribed for your current condition||
0750|223|N|only. Do not use it later for another condition unless your||
0750|224|N|doctor directs you to do so. A different medication may be||
0750|225|N|necessary in that case.||
0750|226|B|||
0750|227|D|MISSED DOSE:  If you are taking this medication on a regular||
0750|228|D|schedule and you miss a dose, take it as soon as you remember. If||
0750|229|D|it is near the time of the next dose, skip the missed dose. Take||
0750|230|D|your next dose at the regular time. Do not double the dose to||
0750|231|D|catch up.||
0750|232|B|||
0750|233|R|STORAGE:  Store at room temperature away from light and moisture.||
0750|234|R|Do not store in the bathroom. Keep all medications away from||
0750|235|R|children and pets. See also Warning section.||
0750|236|R|   Do not flush medications down the toilet or pour them into a||
0750|237|R|drain unless instructed to do so. Properly discard this product||
0750|238|R|when it is expired or no longer needed. For more details, read||
0750|239|R|the Medication Guide, or consult your pharmacist or local waste||
0750|240|R|disposal company.||
0750|241|B|||
0750|242|A|Information last revised August 2025.||
0750|243|A|Copyright(c) 2025 First Databank, Inc.||
0750|244|B|||
0751|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0751|002|Z|does NOT have all possible information about this product. This||
0751|003|Z|information does not assure that this product is safe, effective,||
0751|004|Z|or appropriate for you. This information is not individual||
0751|005|Z|medical advice and does not substitute for the advice of your||
0751|006|Z|health care professional. Always ask your health care||
0751|007|Z|professional for complete information about this product and your||
0751|008|Z|specific health needs.||
0751|009|B|||
0751|010|T|TAMSULOSIN CONTROLLED-RELEASE TABLET - ORAL||
0751|011|F|(tam-SOO-loe-sin)||
0751|012|B|||
0751|013|U|USES:  Tamsulosin is used by men to treat the symptoms of an||
0751|014|U|enlarged prostate (benign prostatic hyperplasia-BPH). It does not||
0751|015|U|shrink the prostate, but it works by relaxing the muscles in the||
0751|016|U|prostate and the bladder. This helps to relieve symptoms of BPH||
0751|017|U|such as difficulty in beginning the flow of urine, weak stream,||
0751|018|U|and the need to urinate often or urgently (including during the||
0751|019|U|middle of the night). Tamsulosin belongs to a class of drugs||
0751|020|U|known as alpha blockers.||
0751|021|U|   Do not use this medication to treat high blood pressure.||
0751|022|B|||
0751|023|V|OTHER USES:  This section contains uses of this drug that are not||
0751|024|V|listed in the approved professional labeling for the drug but||
0751|025|V|that may be prescribed by your health care professional. Use this||
0751|026|V|drug for a condition that is listed in this section only if it||
0751|027|V|has been so prescribed by your health care professional.||
0751|028|V|   This drug may also be used to help your body "pass," or get||
0751|029|V|rid of, kidney stones through urination. It may also be used for||
0751|030|V|bladder problems in women.||
0751|031|B|||
0751|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0751|033|H|from your pharmacist before you start taking this medication and||
0751|034|H|each time you get a refill. If you have any questions, ask your||
0751|035|H|doctor or pharmacist.||
0751|036|H|   Take this medication by mouth with or without food as directed||
0751|037|H|by your doctor, usually once daily.||
0751|038|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
0751|039|H|Doing so can release all of the drug at once, increasing the risk||
0751|040|H|of side effects.||
0751|041|H|   Tamsulosin may cause a sudden drop in your blood pressure,||
0751|042|H|which could lead to dizziness or fainting. This risk is higher||
0751|043|H|when you first start taking this drug or if you restart treatment||
0751|044|H|after you stop taking it. During these times, avoid situations||
0751|045|H|where you may be injured if you faint.||
0751|046|H|   To avoid injury from dizziness or fainting, your doctor may||
0751|047|H|tell you to take your first dose of tamsulosin at bedtime so that||
0751|048|H|your body can get used to its effects.||
0751|049|H|   Take this medication regularly to get the most benefit from||
0751|050|H|it. To help you remember, take it at the same time each day.||
0751|051|H|   It may take up to 4 weeks before your symptoms improve. Tell||
0751|052|H|your doctor if your condition does not get better or if it gets||
0751|053|H|worse.||
0751|054|B|||
0751|055|S|SIDE EFFECTS:  Dizziness, lightheadedness, or ejaculation||
0751|056|S|problems may occur. If any of these effects last or get worse,||
0751|057|S|tell your doctor or pharmacist promptly.||
0751|058|S|   To reduce the risk of dizziness and lightheadedness, get up||
0751|059|S|slowly when rising from a sitting or lying position.||
0751|060|S|   Remember that this medication has been prescribed because your||
0751|061|S|doctor has judged that the benefit to you is greater than the||
0751|062|S|risk of side effects. Many people using this medication do not||
0751|063|S|have serious side effects.||
0751|064|S|   Tell your doctor right away if you have any serious side||
0751|065|S|effects, including: fainting.||
0751|066|S|   Rarely, males may have a painful or prolonged erection lasting||
0751|067|S|4 or more hours. If this occurs, stop using this drug and get||
0751|068|S|medical help right away, or permanent problems could occur.||
0751|069|S|   A very serious allergic reaction to this drug is rare.||
0751|070|S|However, get medical help right away if you notice any symptoms||
0751|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0751|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0751|073|S|breathing.||
0751|074|S|   This is not a complete list of possible side effects. If you||
0751|075|S|notice other effects not listed above, contact your doctor or||
0751|076|S|pharmacist.||
0751|077|S|   In the US -||
0751|078|S|   Call your doctor for medical advice about side effects. You||
0751|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0751|080|S|www.fda.gov/medwatch.||
0751|081|S|   In Canada - Call your doctor for medical advice about side||
0751|082|S|effects. You may report side effects to Health Canada at||
0751|083|S|1-866-234-2345.||
0751|084|B|||
0751|085|P|PRECAUTIONS:  Before taking tamsulosin, tell your doctor or||
0751|086|P|pharmacist if you are allergic to it; or if you have any other||
0751|087|P|allergies. This product may contain inactive ingredients, which||
0751|088|P|can cause allergic reactions or other problems. Talk to your||
0751|089|P|pharmacist for more details.||
0751|090|P|   Before using this medication, tell your doctor or pharmacist||
0751|091|P|your medical history, especially of: low blood pressure, certain||
0751|092|P|eye problems (cataracts, glaucoma).||
0751|093|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0751|094|P|can make you more dizzy. Do not drive, use machinery, or do||
0751|095|P|anything that needs alertness until you can do it safely. Limit||
0751|096|P|alcoholic beverages. Talk to your doctor if you are using||
0751|097|P|marijuana (cannabis).||
0751|098|P|   Before having surgery (including cataract/glaucoma eye||
0751|099|P|surgery), tell your doctor or dentist if you are taking or have||
0751|100|P|ever taken this medication, and about all the other products you||
0751|101|P|use (including prescription drugs, nonprescription drugs, and||
0751|102|P|herbal products).||
0751|103|P|   Older adults may be more sensitive to the side effects of this||
0751|104|P|drug, especially dizziness and low blood pressure when getting up||
0751|105|P|from a sitting or lying position. These side effects can increase||
0751|106|P|the risk of falling.||
0751|107|P|   During pregnancy, this medication should be used only when||
0751|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
0751|109|P|   It is unknown if this medication passes into breast milk.||
0751|110|P|Consult your doctor before breastfeeding.||
0751|111|B|||
0751|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0751|113|I|medications work or increase your risk for serious side effects.||
0751|114|I|This document does not contain all possible drug interactions.||
0751|115|I|Keep a list of all the products you use (including||
0751|116|I|prescription/nonprescription drugs and herbal products) and share||
0751|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
0751|118|I|the dosage of any medicines without your doctor's approval.||
0751|119|I|   Some products that may interact with this drug include: other||
0751|120|I|alpha blocker drugs (such as prazosin, terazosin).||
0751|121|I|   If you are also taking a drug to treat erectile dysfunction-ED||
0751|122|I|or pulmonary hypertension (such as sildenafil, tadalafil), your||
0751|123|I|blood pressure may get too low which can lead to dizziness or||
0751|124|I|fainting. Your doctor may need to adjust your medications to||
0751|125|I|minimize this risk.||
0751|126|I|   Other medications can affect the removal of tamsulosin from||
0751|127|I|your body, which may affect how tamsulosin works. Examples||
0751|128|I|include adagrasib, azole antifungals (such as itraconazole,||
0751|129|I|ketoconazole), clarithromycin, cobicistat, HIV protease||
0751|130|I|inhibitors (such as lopinavir), mifepristone, ribociclib,||
0751|131|I|ritonavir, among others.||
0751|132|B|||
0751|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0751|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0751|135|O|poison control center right away. US residents can call||
0751|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0751|137|O|Symptoms of overdose may include: severe dizziness, fainting.||
0751|138|B|||
0751|139|N|NOTES:  Do not share this medication with others.||
0751|140|N|   Lab and/or medical tests (such as prostate exams, blood||
0751|141|N|pressure) should be done while you are taking this medication.||
0751|142|N|Keep all medical and lab appointments. Consult your doctor for||
0751|143|N|more details.||
0751|144|B|||
0751|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0751|146|D|remember. If it is near the time of the next dose, skip the||
0751|147|D|missed dose. Take your next dose at the regular time. Do not||
0751|148|D|double the dose to catch up.||
0751|149|B|||
0751|150|R|STORAGE:  Store at room temperature away from light and moisture.||
0751|151|R|Do not store in the bathroom. Keep all medications away from||
0751|152|R|children and pets.||
0751|153|R|   Do not flush medications down the toilet or pour them into a||
0751|154|R|drain unless instructed to do so. Properly discard this product||
0751|155|R|when it is expired or no longer needed. Consult your pharmacist||
0751|156|R|or local waste disposal company.||
0751|157|B|||
0751|158|A|Information last revised November 2024.||
0751|159|A|Copyright(c) 2025 First Databank, Inc.||
0751|160|B|||
0752|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0752|002|Z|does NOT have all possible information about this product. This||
0752|003|Z|information does not assure that this product is safe, effective,||
0752|004|Z|or appropriate for you. This information is not individual||
0752|005|Z|medical advice and does not substitute for the advice of your||
0752|006|Z|health care professional. Always ask your health care||
0752|007|Z|professional for complete information about this product and your||
0752|008|Z|specific health needs.||
0752|009|B|||
0752|010|T|OXYMORPHONE EXTENDED-RELEASE - ORAL||
0752|011|F|(OX-i-MOR-fone)||
0752|012|B|||
0752|013|C|COMMON BRAND NAME(S): Opana ER||
0752|014|B|||
0752|015|W|WARNING:  Oxymorphone has a risk for abuse and addiction, which||
0752|016|W|can lead to overdose and death. Oxymorphone may also cause||
0752|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
0752|018|W|your doctor should have you take the smallest dose of oxymorphone||
0752|019|W|that works, and take it for the shortest possible time. See also||
0752|020|W|How to Use section for more information about addiction.||
0752|021|W|   Ask your doctor or pharmacist if you should have medication||
0752|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0752|023|W|Teach your family or household members about the signs of an||
0752|024|W|opioid overdose and how to treat it.||
0752|025|W|   The risk for severe breathing problems is higher when you||
0752|026|W|start this medication and after a dose increase, or if you take||
0752|027|W|the wrong dose/strength. Taking this medication with alcohol or||
0752|028|W|other drugs that can cause drowsiness or breathing problems may||
0752|029|W|cause very serious side effects, including death. Be sure you||
0752|030|W|know how to take oxymorphone and what other drugs you should||
0752|031|W|avoid taking with it. See also Drug Interactions section. Get||
0752|032|W|medical help right away if any of these very serious side effects||
0752|033|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
0752|034|W|drowsiness/dizziness, difficulty waking up.||
0752|035|W|   This medication must be swallowed whole. Do not break, chew,||
0752|036|W|dissolve, or crush the medication. This may cause a rapid release||
0752|037|W|of the medication that may be fatal. Also, do not drink alcohol||
0752|038|W|or take any products that contain alcohol while taking this||
0752|039|W|medication. This may cause an increase of the medication in your||
0752|040|W|body that may be fatal.||
0752|041|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0752|042|W|or abuse. If someone accidentally swallows this drug, get medical||
0752|043|W|help right away.||
0752|044|W|   Before using this medication, women of childbearing age should||
0752|045|W|talk with their doctor(s) about the risks and benefits. Tell your||
0752|046|W|doctor if you are pregnant or if you plan to become pregnant.||
0752|047|W|During pregnancy, this medication should be used only when||
0752|048|W|clearly needed. It may slightly increase the risk of birth||
0752|049|W|defects if used during the first two months of pregnancy. Also,||
0752|050|W|using it for a long time or in high doses near the expected||
0752|051|W|delivery date may harm the unborn baby. To lessen the risk, take||
0752|052|W|the smallest effective dose for the shortest possible time.||
0752|053|W|Babies born to mothers who use this drug for a long time may||
0752|054|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0752|055|W|doctor right away if you notice any symptoms in your newborn baby||
0752|056|W|such as crying that doesn't stop, slow/shallow breathing,||
0752|057|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0752|058|W|difficulty gaining weight.||
0752|059|B|||
0752|060|U|USES:  Oxymorphone extended-release is used to help relieve||
0752|061|U|severe ongoing pain. It belongs to a class of drugs known as||
0752|062|U|long-acting opioid analgesics. It works in the brain to change||
0752|063|U|how your body feels and responds to pain.||
0752|064|U|   Do not use the extended-release form of oxymorphone to relieve||
0752|065|U|pain that is mild or that will go away in a few days. This||
0752|066|U|medication is not for occasional ("as needed") use.||
0752|067|B|||
0752|068|H|HOW TO USE:  See also Warning section.||
0752|069|H|   Read the Medication Guide provided by your pharmacist before||
0752|070|H|you start taking oxymorphone extended-release and each time you||
0752|071|H|get a refill. If you have any questions, ask your doctor or||
0752|072|H|pharmacist.||
0752|073|H|   Take this medication on a regular schedule as directed by your||
0752|074|H|doctor, not as needed for sudden (breakthrough) pain.||
0752|075|H|   Take this medication by mouth without food (at least 1 hour||
0752|076|H|before or 2 hours after eating) as directed by your doctor,||
0752|077|H|usually every 12 hours. Swallow the tablets whole. Do not break,||
0752|078|H|chew, dissolve, or crush them. Do not pre-soak, lick, or wet the||
0752|079|H|tablets before putting them in your mouth. Take one tablet at a||
0752|080|H|time with enough water to completely swallow the tablet. If you||
0752|081|H|have nausea, ask your doctor or pharmacist about ways to decrease||
0752|082|H|nausea (such as lying down for 1 to 2 hours with as little head||
0752|083|H|movement as possible).||
0752|084|H|   The dosage is based on your medical condition and response to||
0752|085|H|treatment. Do not increase your dose or use this drug more often||
0752|086|H|or for longer than prescribed because your risk of side effects||
0752|087|H|may increase. Properly stop the medication when so directed.||
0752|088|H|   Before you start using this medication, ask your doctor or||
0752|089|H|pharmacist if you should stop or change how you use your other||
0752|090|H|opioid medication(s). Other pain relievers (such as||
0752|091|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
0752|092|H|or pharmacist about using oxymorphone safely with other drugs.||
0752|093|H|   Suddenly stopping this medication may cause withdrawal,||
0752|094|H|especially if you have used it for a long time or in high doses.||
0752|095|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0752|096|H|Tell your doctor or pharmacist right away if you have any||
0752|097|H|withdrawal symptoms such as restlessness, mental/mood changes||
0752|098|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0752|099|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0752|100|H|aches, or sudden changes in behavior.||
0752|101|H|   When this medication is used for a long time, it may not work||
0752|102|H|as well. Talk with your doctor if this medication stops working||
0752|103|H|well.||
0752|104|H|   Though it helps many people, this medication may sometimes||
0752|105|H|cause addiction. This risk may be higher if you have a||
0752|106|H|mental/mood disorder or a substance use disorder (such as overuse||
0752|107|H|of or addiction to drugs/alcohol). Take this medication exactly||
0752|108|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0752|109|H|pharmacist for more details.||
0752|110|H|   Tell your doctor if your pain does not get better or if it||
0752|111|H|gets worse, or if you have any new pain.||
0752|112|B|||
0752|113|S|SIDE EFFECTS:  See also Warning section.||
0752|114|S|   Nausea, vomiting, headache, constipation, dry mouth, mild||
0752|115|S|itching, lightheadedness, dizziness, or drowsiness may occur. If||
0752|116|S|any of these effects last or get worse, tell your doctor or||
0752|117|S|pharmacist promptly.||
0752|118|S|   To prevent constipation, eat dietary fiber, drink enough||
0752|119|S|water, and exercise. You may also need to take a laxative. Ask||
0752|120|S|your pharmacist which type of laxative is right for you.||
0752|121|S|   To reduce the risk of dizziness and lightheadedness, get up||
0752|122|S|slowly when rising from a sitting or lying position.||
0752|123|S|   Sometimes a soft mass that looks like the tablet may appear in||
0752|124|S|your stool. This effect is harmless because your body has already||
0752|125|S|absorbed the medication.||
0752|126|S|   Remember that this medication has been prescribed because your||
0752|127|S|doctor has judged that the benefit to you is greater than the||
0752|128|S|risk of side effects. Many people using this medication do not||
0752|129|S|have serious side effects.||
0752|130|S|   Tell your doctor right away if you have any serious side||
0752|131|S|effects, including: interrupted breathing during sleep (sleep||
0752|132|S|apnea), mental/mood changes (such as agitation, confusion,||
0752|133|S|hallucinations), stomach/abdominal pain, vision changes,||
0752|134|S|slow/fast heartbeat, difficulty urinating, signs of your adrenal||
0752|135|S|glands not working well (such as loss of appetite, unusual||
0752|136|S|tiredness, weight loss), trouble swallowing.||
0752|137|S|   Get medical help right away if you have any very serious side||
0752|138|S|effects, including: slow/shallow breathing, fainting, seizure,||
0752|139|S|severe drowsiness/difficulty waking up.||
0752|140|S|   A very serious allergic reaction to this drug is rare.||
0752|141|S|However, get medical help right away if you notice any symptoms||
0752|142|S|of a serious allergic reaction, including: rash, itching/swelling||
0752|143|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0752|144|S|breathing.||
0752|145|S|   This is not a complete list of possible side effects. If you||
0752|146|S|notice other effects not listed above, contact your doctor or||
0752|147|S|pharmacist.||
0752|148|S|   In the US -||
0752|149|S|   Call your doctor for medical advice about side effects. You||
0752|150|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0752|151|S|www.fda.gov/medwatch.||
0752|152|S|   In Canada - Call your doctor for medical advice about side||
0752|153|S|effects. You may report side effects to Health Canada at||
0752|154|S|1-866-234-2345.||
0752|155|B|||
0752|156|P|PRECAUTIONS:  Before taking oxymorphone, tell your doctor or||
0752|157|P|pharmacist if you are allergic to it; or to other opioid pain||
0752|158|P|medications (such as codeine, morphine, oxycodone); or if you||
0752|159|P|have any other allergies. This product may contain inactive||
0752|160|P|ingredients, which can cause allergic reactions or other||
0752|161|P|problems. Talk to your pharmacist for more details.||
0752|162|P|   Before using this medication, tell your doctor or pharmacist||
0752|163|P|your medical history, especially of: brain disorders (such as||
0752|164|P|head injury, tumor, seizures), breathing problems (such as||
0752|165|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0752|166|P|gallbladder disease, kidney disease, liver disease, mental/mood||
0752|167|P|disorders (such as confusion, depression, thoughts of suicide),||
0752|168|P|personal or family history of a substance use disorder (such as||
0752|169|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
0752|170|P|problems (such as blockage, surgery, constipation, diarrhea due||
0752|171|P|to infection, paralytic ileus), cancer of the esophagus or colon,||
0752|172|P|difficulty swallowing, disease of the pancreas (pancreatitis),||
0752|173|P|difficulty urinating (such as due to enlarged prostate).||
0752|174|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0752|175|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0752|176|P|machinery, or do anything that needs alertness until you can do||
0752|177|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0752|178|P|are using marijuana (cannabis).||
0752|179|P|   Before having surgery, tell your doctor or dentist about all||
0752|180|P|the products you use (including prescription drugs,||
0752|181|P|nonprescription drugs, and herbal products).||
0752|182|P|   Older adults may be more sensitive to the side effects of the||
0752|183|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
0752|184|P|breathing.||
0752|185|P|   During pregnancy, this medication should be used only when||
0752|186|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0752|187|P|benefits with your doctor. (See also Warning section.)||
0752|188|P|   It is unknown if this drug passes into breast milk. However,||
0752|189|P|similar drugs pass into breast milk and may have undesirable||
0752|190|P|effects on a nursing infant. Tell the doctor right away if your||
0752|191|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0752|192|P|breathing. Consult your doctor before breastfeeding.||
0752|193|B|||
0752|194|I|DRUG INTERACTIONS:  See also Warning section.||
0752|195|I|   Drug interactions may change how your medications work or||
0752|196|I|increase your risk for serious side effects. This document does||
0752|197|I|not contain all possible drug interactions. Keep a list of all||
0752|198|I|the products you use (including prescription/nonprescription||
0752|199|I|drugs and herbal products) and share it with your doctor and||
0752|200|I|pharmacist. Do not start, stop, or change the dosage of any||
0752|201|I|medicines without your doctor's approval.||
0752|202|I|   Some products that may interact with this drug include:||
0752|203|I|certain pain medications (mixed opioid agonist-antagonists such||
0752|204|I|as butorphanol, nalbuphine, pentazocine), naltrexone, products||
0752|205|I|that contain alcohol (such as cough-and-cold syrups),||
0752|206|I|samidorphan.||
0752|207|I|   The risk of serious side effects (such as slow/shallow||
0752|208|I|breathing, severe drowsiness/dizziness) may be increased if this||
0752|209|I|medication is taken with other products that may also cause||
0752|210|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0752|211|I|if you are taking other products such as other opioid pain or||
0752|212|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0752|213|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0752|214|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0752|215|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0752|216|I|cetirizine, diphenhydramine).||
0752|217|I|   Check the labels on all your medicines (such as allergy or||
0752|218|I|cough-and-cold products) because they may contain ingredients||
0752|219|I|that cause drowsiness. Ask your pharmacist about using those||
0752|220|I|products safely.||
0752|221|I|   This medication may interfere with certain lab tests (such as||
0752|222|I|amylase and lipase levels), possibly causing false test results.||
0752|223|I|Make sure lab personnel and all your doctors know you use this||
0752|224|I|drug.||
0752|225|B|||
0752|226|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0752|227|O|as passing out or trouble breathing, give them naloxone or||
0752|228|O|nalmefene if available, then call 911. If the person is awake and||
0752|229|O|has no symptoms, call a poison control center right away. US||
0752|230|O|residents can call 1-800-222-1222. Canada residents can call||
0752|231|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0752|232|O|breathing, slow heartbeat, coma.||
0752|233|B|||
0752|234|N|NOTES:  Do not share this medication with others. Sharing it is||
0752|235|N|against the law.||
0752|236|N|   This medication has been prescribed for your current condition||
0752|237|N|only. Do not use it later for another condition unless your||
0752|238|N|doctor directs you to do so. A different medication may be||
0752|239|N|necessary in that case.||
0752|240|B|||
0752|241|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0752|242|D|remember. If it is near the time of the next dose, skip the||
0752|243|D|missed dose. Take your next dose at the regular time. Do not||
0752|244|D|double the dose to catch up.||
0752|245|B|||
0752|246|R|STORAGE:  Store at room temperature away from light and moisture.||
0752|247|R|Do not store in the bathroom. Keep all medications away from||
0752|248|R|children and pets. See also Warning section.||
0752|249|R|   Do not flush medications down the toilet or pour them into a||
0752|250|R|drain unless instructed to do so. Properly discard this product||
0752|251|R|when it is expired or no longer needed. For more details, read||
0752|252|R|the Medication Guide, or consult your pharmacist or local waste||
0752|253|R|disposal company.||
0752|254|B|||
0752|255|A|Information last revised August 2025.||
0752|256|A|Copyright(c) 2025 First Databank, Inc.||
0752|257|B|||
0756|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0756|002|Z|does NOT have all possible information about this product. This||
0756|003|Z|information does not assure that this product is safe, effective,||
0756|004|Z|or appropriate for you. This information is not individual||
0756|005|Z|medical advice and does not substitute for the advice of your||
0756|006|Z|health care professional. Always ask your health care||
0756|007|Z|professional for complete information about this product and your||
0756|008|Z|specific health needs.||
0756|009|B|||
0756|010|T|PHENOBARBITAL - ORAL||
0756|011|F|(fee-no-BARB-ih-tall)||
0756|012|B|||
0756|013|C|COMMON BRAND NAME(S): Luminal||
0756|014|B|||
0756|015|U|USES:  This medication is used alone or with other medications to||
0756|016|U|control seizures. Controlling and reducing seizures lets you do||
0756|017|U|more of your normal daily activities, reduces your risk of harm||
0756|018|U|when you lose consciousness, and lessens your risk for a possibly||
0756|019|U|life-threatening condition of frequent, repeated seizures.||
0756|020|U|Phenobarbital belongs to a class of drugs known as barbiturate||
0756|021|U|anticonvulsants/hypnotics. It works by controlling the abnormal||
0756|022|U|electrical activity in the brain that occurs during a seizure.||
0756|023|U|This medication is also used for a short time (usually no more||
0756|024|U|than 2 weeks) to help calm you or help you sleep during periods||
0756|025|U|of anxiety. It works by affecting certain parts of the brain to||
0756|026|U|cause calming.||
0756|027|B|||
0756|028|H|HOW TO USE:  Take this medication by mouth with or without food||
0756|029|H|as directed by your doctor, usually once daily at bedtime for||
0756|030|H|seizure control. Take with food or milk if stomach upset occurs.||
0756|031|H|If you are using the liquid form of this medication, measure the||
0756|032|H|dose carefully using a special measuring device/cup. Do not use a||
0756|033|H|household spoon because you may not get the correct dose.||
0756|034|H|   The dosage is based on your medical condition, phenobarbital||
0756|035|H|blood levels, and response to treatment. Children's dosage may||
0756|036|H|also be based on weight.||
0756|037|H|   Your doctor may direct you to start this medication at a low||
0756|038|H|dose and gradually increase your dose to prevent side effects||
0756|039|H|such as drowsiness and dizziness. Follow your doctor's||
0756|040|H|instructions carefully. Do not take more or less of this drug||
0756|041|H|than prescribed.||
0756|042|H|   It may take several weeks to reach the best dose for you and||
0756|043|H|completely control your seizures. This medication works best when||
0756|044|H|the amount of drug in your body is kept at a constant level. Take||
0756|045|H|it at the same time(s) each day.||
0756|046|H|   Do not stop taking this medication (and other anticonvulsant||
0756|047|H|medications) without consulting your doctor. Your seizures may||
0756|048|H|worsen or cause a very severe seizure that is difficult to treat||
0756|049|H|(status epilepticus) when this drug is suddenly stopped.||
0756|050|H|   If you suddenly stop using this medication, you may have||
0756|051|H|withdrawal symptoms (such as anxiety, hallucinations, twitching,||
0756|052|H|trouble sleeping). Withdrawal from phenobarbital can be severe||
0756|053|H|and include seizures and (rarely) death. To help prevent||
0756|054|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0756|055|H|more likely if you have used phenobarbital for a long time or in||
0756|056|H|high doses. Tell your doctor or pharmacist right away if you have||
0756|057|H|withdrawal.||
0756|058|H|   Though it helps many people, this medication may sometimes||
0756|059|H|cause addiction. This risk may be higher if you have a substance||
0756|060|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0756|061|H|Take this medication exactly as prescribed to lower the risk of||
0756|062|H|addiction. Ask your doctor or pharmacist for more details.||
0756|063|H|   When this medication is used for a long time for anxiety or to||
0756|064|H|help you sleep, it may not work as well. Phenobarbital should||
0756|065|H|only be used for a short time for anxiety or sleep. Talk with||
0756|066|H|your doctor if this medication stops working well.||
0756|067|H|   Tell your doctor if your anxiety or seizure control gets worse||
0756|068|H|(such as the number of seizures increases).||
0756|069|B|||
0756|070|S|SIDE EFFECTS:  Dizziness, drowsiness, excitation, headache,||
0756|071|S|tiredness, loss of appetite, nausea, or vomiting may occur as||
0756|072|S|your body adjusts to the medication. If any of these effects last||
0756|073|S|or get worse, notify your doctor or pharmacist promptly.||
0756|074|S|   Remember that this medication has been prescribed because your||
0756|075|S|doctor has judged that the benefit to you is greater than the||
0756|076|S|risk of side effects. Many people using this medication do not||
0756|077|S|have serious side effects.||
0756|078|S|   A small number of people who take anticonvulsants for any||
0756|079|S|condition (such as seizure, bipolar disorder, pain) may||
0756|080|S|experience depression, suicidal thoughts/attempts, or other||
0756|081|S|mental/mood problems. Tell your doctor right away if you or your||
0756|082|S|family/caregiver notice any unusual/sudden changes in your mood,||
0756|083|S|thoughts, or behavior including signs of depression, suicidal||
0756|084|S|thoughts/attempts, thoughts about harming yourself.||
0756|085|S|   Tell your doctor right away if you have any serious side||
0756|086|S|effects, including: staggering walk/clumsiness, double vision,||
0756|087|S|fainting, slow heartbeat, severe tiredness/weakness, pale skin.||
0756|088|S|   Get medical help right away if you have any very serious side||
0756|089|S|effects, including: slow/shallow breathing.||
0756|090|S|   A very serious allergic reaction to this drug is rare.||
0756|091|S|However, get medical help right away if you notice any symptoms||
0756|092|S|of a serious allergic reaction, including: fever, swollen lymph||
0756|093|S|nodes, rash, itching/swelling (especially of the||
0756|094|S|face/tongue/throat), severe dizziness, trouble breathing.||
0756|095|S|   This is not a complete list of possible side effects. If you||
0756|096|S|notice other effects not listed above, contact your doctor or||
0756|097|S|pharmacist.||
0756|098|S|   In the US -||
0756|099|S|   Call your doctor for medical advice about side effects. You||
0756|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0756|101|S|www.fda.gov/medwatch.||
0756|102|S|   In Canada - Call your doctor for medical advice about side||
0756|103|S|effects. You may report side effects to Health Canada at||
0756|104|S|1-866-234-2345.||
0756|105|B|||
0756|106|P|PRECAUTIONS:  Before taking phenobarbital, tell your doctor or||
0756|107|P|pharmacist if you are allergic to it; or to other barbiturates||
0756|108|P|(such as primidone, secobarbital); or to other anti-seizure||
0756|109|P|medications (such as carbamazepine, fosphenytoin, oxcarbazepine,||
0756|110|P|phenytoin); or if you have any other allergies. This product may||
0756|111|P|contain inactive ingredients, which can cause allergic reactions||
0756|112|P|or other problems. Talk to your pharmacist for more details.||
0756|113|P|   Before using this medication, tell your doctor or pharmacist||
0756|114|P|your medical history, especially of: certain hormone problems||
0756|115|P|(adrenal disease such as Addison's disease), liver problems,||
0756|116|P|kidney problems, lung disease (such as sleep apnea, chronic||
0756|117|P|obstructive pulmonary disease-COPD), mental/mood disorders (such||
0756|118|P|as depression, thoughts of suicide), personal or family history||
0756|119|P|of a substance use disorder (such as overuse of or addiction to||
0756|120|P|drugs/alcohol), personal/family history of a certain blood||
0756|121|P|disorder (porphyria), certain vitamin deficiencies (folic acid,||
0756|122|P|vitamin K).||
0756|123|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0756|124|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0756|125|P|machinery, or do anything that needs alertness until you can do||
0756|126|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0756|127|P|are using marijuana (cannabis).||
0756|128|P|   The liquid form of this product may contain alcohol or sugar.||
0756|129|P|Caution is advised if you have diabetes, alcohol dependence,||
0756|130|P|liver disease, or any other condition that requires you to||
0756|131|P|limit/avoid these substances in your diet. Ask your doctor or||
0756|132|P|pharmacist about using this product safely.||
0756|133|P|   Before having surgery, tell your doctor or dentist about all||
0756|134|P|the products you use (including prescription drugs,||
0756|135|P|nonprescription drugs, and herbal products).||
0756|136|P|   Older adults may be more sensitive to the side effects of this||
0756|137|P|drug, especially drowsiness and dizziness. However, this drug can||
0756|138|P|often cause excitement or confusion instead of drowsiness in||
0756|139|P|older adults. Drowsiness, confusion, and dizziness can increase||
0756|140|P|the risk of falling.||
0756|141|P|   Children may be more sensitive to the side effects of the||
0756|142|P|drug. This drug can often cause excitement instead of drowsiness||
0756|143|P|in young children.||
0756|144|P|   During pregnancy, this medication should be used only when||
0756|145|P|clearly needed. It may harm an unborn baby. Newborn babies of||
0756|146|P|mothers who use this medication late in pregnancy may have||
0756|147|P|symptoms such as slow/shallow breathing, nonstop crying, shaking,||
0756|148|P|or trouble feeding. However, since untreated seizures are a||
0756|149|P|serious condition that can harm both a pregnant woman and her||
0756|150|P|unborn baby, do not stop taking this medication unless directed||
0756|151|P|by your doctor. If you are planning pregnancy, become pregnant,||
0756|152|P|or think you may be pregnant, discuss with your doctor right away||
0756|153|P|the benefits and risks of using this medication during pregnancy.||
0756|154|P|Since birth control pills, patches, implants, and injections may||
0756|155|P|not work if taken with this medication (see also Drug||
0756|156|P|Interactions section), discuss reliable forms of birth control||
0756|157|P|with your doctor.||
0756|158|P|   This medication passes into breast milk and may cause||
0756|159|P|excessive sleepiness or feeding problems in the nursing infant.||
0756|160|P|Consult your doctor before breastfeeding.||
0756|161|B|||
0756|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0756|163|I|medications work or increase your risk for serious side effects.||
0756|164|I|This document does not contain all possible drug interactions.||
0756|165|I|Keep a list of all the products you use (including||
0756|166|I|prescription/nonprescription drugs and herbal products) and share||
0756|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
0756|168|I|the dosage of any medicines without your doctor's approval.||
0756|169|I|   Some products that may interact with this drug include:||
0756|170|I|darunavir, orlistat.||
0756|171|I|   Other medications can affect the removal of phenobarbital from||
0756|172|I|your body, which may affect how phenobarbital works. Examples||
0756|173|I|include St. John's wort, among others.||
0756|174|I|   This medication can speed up the removal of other medications||
0756|175|I|from your body, which may affect how they work. Examples of||
0756|176|I|affected drugs include artemether/lumefantrine, atazanavir,||
0756|177|I|cobicistat, etravirine, lurasidone, ranolazine, rilpivirine,||
0756|178|I|sofosbuvir, sorafenib, voriconazole, certain calcium channel||
0756|179|I|blockers (such as felodipine/nimodipine), among others.||
0756|180|I|   This medication may decrease the effectiveness of hormonal||
0756|181|I|birth control such as pills, patch, or ring. This could cause||
0756|182|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0756|183|I|use reliable backup birth control methods while using this||
0756|184|I|medication. Also tell your doctor if you have any new spotting or||
0756|185|I|breakthrough bleeding, because these may be signs that your birth||
0756|186|I|control is not working well.||
0756|187|I|   The risk of serious side effects (such as slow/shallow||
0756|188|I|breathing, severe drowsiness/dizziness) may be increased if this||
0756|189|I|medication is taken with other products that may also cause||
0756|190|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0756|191|I|if you are taking other products such as opioid pain or cough||
0756|192|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0756|193|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0756|194|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0756|195|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0756|196|I|diphenhydramine).||
0756|197|I|   Check the labels on all your medicines (such as allergy or||
0756|198|I|cough-and-cold products) because they may contain ingredients||
0756|199|I|that cause drowsiness. Ask your pharmacist about using those||
0756|200|I|products safely.||
0756|201|I|   Phenobarbital is very similar to primidone. Do not use||
0756|202|I|medications containing primidone while using phenobarbital.||
0756|203|B|||
0756|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0756|205|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0756|206|O|poison control center right away. US residents can call||
0756|207|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0756|208|O|Symptoms of overdose may include: severe tiredness/dizziness,||
0756|209|O|inability to wake up, very slow breathing rate.||
0756|210|B|||
0756|211|N|NOTES:  Do not share this medication with others. Sharing it is||
0756|212|N|against the law.||
0756|213|N|   For long-term use, lab and/or medical tests (such as||
0756|214|N|phenobarbital blood levels, blood counts, liver/kidney function)||
0756|215|N|should be done while you are taking this medication. Keep all||
0756|216|N|medical and lab appointments. Consult your doctor for more||
0756|217|N|details.||
0756|218|B|||
0756|219|D|MISSED DOSE:  If you are taking this medication to prevent||
0756|220|D|seizures and miss a dose, take it as soon as you remember unless||
0756|221|D|it is almost time for the next dose. In that case, skip the||
0756|222|D|missed dose. Take your next dose at the regular time. Do not||
0756|223|D|double the dose to catch up.||
0756|224|B|||
0756|225|R|STORAGE:  Store at room temperature away from light and moisture.||
0756|226|R|Do not store in the bathroom. Keep all medications away from||
0756|227|R|children and pets.||
0756|228|R|   Do not flush medications down the toilet or pour them into a||
0756|229|R|drain unless instructed to do so. Properly discard this product||
0756|230|R|when it is expired or no longer needed. Consult your pharmacist||
0756|231|R|or local waste disposal company.||
0756|232|B|||
0756|233|M|MEDICAL ALERT:  Your condition can cause complications in a||
0756|234|M|medical emergency. For information about enrolling in MedicAlert,||
0756|235|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0756|236|B|||
0756|237|A|Information last revised March 2025.||
0756|238|A|Copyright(c) 2025 First Databank, Inc.||
0756|239|B|||
0757|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0757|002|Z|does NOT have all possible information about this product. This||
0757|003|Z|information does not assure that this product is safe, effective,||
0757|004|Z|or appropriate for you. This information is not individual||
0757|005|Z|medical advice and does not substitute for the advice of your||
0757|006|Z|health care professional. Always ask your health care||
0757|007|Z|professional for complete information about this product and your||
0757|008|Z|specific health needs.||
0757|009|B|||
0757|010|T|MORPHINE SUPPOSITORY - RECTAL||
0757|011|F|(MORE-feen)||
0757|012|B|||
0757|013|C|COMMON BRAND NAME(S): Roxanol||
0757|014|B|||
0757|015|W|WARNING:  Morphine has a risk for abuse and addiction, which can||
0757|016|W|lead to overdose and death. Morphine may also cause severe,||
0757|017|W|possibly fatal, breathing problems. To lower your risk, your||
0757|018|W|doctor should have you use the smallest dose of morphine that||
0757|019|W|works, and use it for the shortest possible time. See also How to||
0757|020|W|Use section for more information about addiction.||
0757|021|W|   Ask your doctor or pharmacist if you should have medication||
0757|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0757|023|W|Teach your family or household members about the signs of an||
0757|024|W|opioid overdose and how to treat it.||
0757|025|W|   The risk for severe breathing problems is higher when you||
0757|026|W|start this medication and after a dose increase, or if you use||
0757|027|W|the wrong dose/strength. Using this medication with alcohol or||
0757|028|W|other drugs that can cause drowsiness or breathing problems may||
0757|029|W|cause very serious side effects, including death. Be sure you||
0757|030|W|know how to use morphine and what other drugs you should avoid||
0757|031|W|taking with it. See also Drug Interactions section. Get medical||
0757|032|W|help right away if any of these very serious side effects occur:||
0757|033|W|slow/shallow breathing, unusual lightheadedness, severe||
0757|034|W|drowsiness/dizziness, difficulty waking up.||
0757|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0757|036|W|or abuse. If someone accidentally swallows or uses this drug, get||
0757|037|W|medical help right away.||
0757|038|W|   Before using this medication, women of childbearing age should||
0757|039|W|talk with their doctor(s) about the risks and benefits. Tell your||
0757|040|W|doctor if you are pregnant or if you plan to become pregnant.||
0757|041|W|During pregnancy, this medication should be used only when||
0757|042|W|clearly needed. It may slightly increase the risk of birth||
0757|043|W|defects if used during the first two months of pregnancy. Also,||
0757|044|W|using it for a long time or in high doses near the expected||
0757|045|W|delivery date may harm the unborn baby. To lessen the risk, use||
0757|046|W|the smallest effective dose for the shortest possible time.||
0757|047|W|Babies born to mothers who use this drug for a long time may||
0757|048|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0757|049|W|doctor right away if you notice any symptoms in your newborn baby||
0757|050|W|such as crying that doesn't stop, slow/shallow breathing,||
0757|051|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0757|052|W|difficulty gaining weight.||
0757|053|B|||
0757|054|U|USES:  This medication is used to treat moderate-to-severe pain.||
0757|055|U|It acts on certain centers in the brain to give you pain relief.||
0757|056|U|This medication is an opioid analgesic.||
0757|057|B|||
0757|058|H|HOW TO USE:  Read the Medication Guide provided by your||
0757|059|H|pharmacist before you start using morphine and each time you get||
0757|060|H|a refill. If you have any questions, consult your doctor or||
0757|061|H|pharmacist.||
0757|062|H|   Unwrap and insert one suppository rectally as directed by your||
0757|063|H|doctor. Lie down on your left side with right knee bent. Gently||
0757|064|H|push the suppository into the rectum with your finger. Remain||
0757|065|H|lying down for a few minutes, and avoid having a bowel movement||
0757|066|H|for an hour or longer so the drug will be absorbed. The||
0757|067|H|suppository is for rectal use only.||
0757|068|H|   The dosage is based on your medical condition and response to||
0757|069|H|treatment. Pain medications work best if they are used as the||
0757|070|H|first signs of pain occur. If you wait until the pain has||
0757|071|H|worsened, the medication may not work as well.||
0757|072|H|   You may also take long-acting opioid medications or use opioid||
0757|073|H|patches for ongoing pain if so directed by your doctor. In that||
0757|074|H|case, this medication might be used for sudden (breakthrough)||
0757|075|H|pain only as needed. Also follow your doctor's or pharmacist's||
0757|076|H|instructions for safely using other pain relievers (such as||
0757|077|H|naproxen, ibuprofen). Ask your doctor or pharmacist about using||
0757|078|H|morphine safely with other drugs.||
0757|079|H|   Suddenly stopping this medication may cause withdrawal,||
0757|080|H|especially if you have used it for a long time or in high doses.||
0757|081|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0757|082|H|Tell your doctor or pharmacist right away if you have any||
0757|083|H|withdrawal symptoms such as restlessness, mental/mood changes||
0757|084|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0757|085|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0757|086|H|aches, or sudden changes in behavior.||
0757|087|H|   Though it helps many people, this medication may sometimes||
0757|088|H|cause addiction. This risk may be higher if you have a||
0757|089|H|mental/mood disorder or a substance use disorder (such as overuse||
0757|090|H|of or addiction to drugs/alcohol). Use this medication exactly as||
0757|091|H|prescribed to lower the risk of addiction. Ask your doctor or||
0757|092|H|pharmacist for more details.||
0757|093|H|   When used for an extended period, this medication may not work||
0757|094|H|as well and may require different dosing. Talk with your doctor||
0757|095|H|if this medication stops working well.||
0757|096|H|   Tell your doctor if your pain does not get better or if it||
0757|097|H|gets worse, or if you have any new pain.||
0757|098|B|||
0757|099|S|SIDE EFFECTS:  See also Warning section.||
0757|100|S|   Nausea, vomiting, dry mouth, constipation, increased sweating,||
0757|101|S|lightheadedness, dizziness, or drowsiness may occur. If any of||
0757|102|S|these effects last or get worse, notify your doctor or pharmacist||
0757|103|S|promptly.||
0757|104|S|   To prevent constipation, eat dietary fiber, drink enough||
0757|105|S|water, and exercise. You may also need to take a laxative. Ask||
0757|106|S|your pharmacist which type of laxative is right for you.||
0757|107|S|   To reduce the risk of dizziness and lightheadedness, get up||
0757|108|S|slowly when rising from a sitting or lying position.||
0757|109|S|   Remember that this medication has been prescribed because your||
0757|110|S|doctor has judged that the benefit to you is greater than the||
0757|111|S|risk of side effects. Many people using this medication do not||
0757|112|S|have serious side effects.||
0757|113|S|   Tell your doctor right away if you have any serious side||
0757|114|S|effects, including: interrupted breathing during sleep (sleep||
0757|115|S|apnea), mental/mood changes, vision changes, slow/fast heartbeat,||
0757|116|S|difficulty urinating, severe stomach/abdominal pain, signs of||
0757|117|S|your adrenal glands not working well (such as loss of appetite,||
0757|118|S|unusual tiredness, weight loss), trouble swallowing.||
0757|119|S|   Get medical help right away if you have any very serious side||
0757|120|S|effects, including: slow/shallow breathing, fainting, seizures,||
0757|121|S|severe drowsiness/difficulty waking up.||
0757|122|S|   A very serious allergic reaction to this drug is rare.||
0757|123|S|However, get medical help right away if you notice any symptoms||
0757|124|S|of a serious allergic reaction, including: rash, itching/swelling||
0757|125|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0757|126|S|breathing.||
0757|127|S|   This is not a complete list of possible side effects. If you||
0757|128|S|notice other effects not listed above, contact your doctor or||
0757|129|S|pharmacist.||
0757|130|S|   In the US -||
0757|131|S|   Call your doctor for medical advice about side effects. You||
0757|132|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0757|133|S|www.fda.gov/medwatch.||
0757|134|S|   In Canada - Call your doctor for medical advice about side||
0757|135|S|effects. You may report side effects to Health Canada at||
0757|136|S|1-866-234-2345.||
0757|137|B|||
0757|138|P|PRECAUTIONS:  Before using morphine, tell your doctor or||
0757|139|P|pharmacist if you are allergic to it; or to other opioid pain||
0757|140|P|medications (such as codeine); or if you have any other||
0757|141|P|allergies. This product may contain inactive ingredients, which||
0757|142|P|can cause allergic reactions or other problems. Talk to your||
0757|143|P|pharmacist for more details.||
0757|144|P|   Before using this medication, tell your doctor or pharmacist||
0757|145|P|your medical history, especially of: brain disorders (such as||
0757|146|P|head injury, tumor, seizures), breathing problems (such as||
0757|147|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0757|148|P|gallbladder disease, kidney disease, liver disease, mental/mood||
0757|149|P|disorders (such as confusion, depression, thoughts of suicide),||
0757|150|P|personal or family history of a substance use disorder (such as||
0757|151|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
0757|152|P|problems (such as blockage, constipation, diarrhea due to||
0757|153|P|infection, paralytic ileus), disease of the pancreas||
0757|154|P|(pancreatitis), difficulty urinating (such as due to enlarged||
0757|155|P|prostate).||
0757|156|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0757|157|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0757|158|P|machinery, or do anything that needs alertness until you can do||
0757|159|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0757|160|P|are using marijuana (cannabis).||
0757|161|P|   Before having surgery, tell your doctor or dentist about all||
0757|162|P|the products you use (including prescription drugs,||
0757|163|P|nonprescription drugs, and herbal products).||
0757|164|P|   Older adults may be more sensitive to the side effects of this||
0757|165|P|drug, especially confusion, dizziness, drowsiness, and||
0757|166|P|slow/shallow breathing.||
0757|167|P|   During pregnancy, this medication should be used only when||
0757|168|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0757|169|P|benefits with your doctor. (See also Warning section.)||
0757|170|P|   This drug passes into breast milk and may have undesirable||
0757|171|P|effects on a nursing infant. Tell the doctor right away if your||
0757|172|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0757|173|P|breathing. Consult your doctor before breastfeeding.||
0757|174|B|||
0757|175|I|DRUG INTERACTIONS:  See also Warning section.||
0757|176|I|   Drug interactions may change how your medications work or||
0757|177|I|increase your risk for serious side effects. This document does||
0757|178|I|not contain all possible drug interactions. Keep a list of all||
0757|179|I|the products you use (including prescription/nonprescription||
0757|180|I|drugs and herbal products) and share it with your doctor and||
0757|181|I|pharmacist. Do not start, stop, or change the dosage of any||
0757|182|I|medicines without your doctor's approval.||
0757|183|I|   Some products that may interact with this drug include:||
0757|184|I|certain pain medications (mixed opioid agonist/antagonists such||
0757|185|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0757|186|I|samidorphan.||
0757|187|I|   The risk of serious side effects (such as slow/shallow||
0757|188|I|breathing, severe drowsiness/dizziness) may be increased if this||
0757|189|I|medication is used with other products that may also cause||
0757|190|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0757|191|I|if you are using other products such as other opioid pain or||
0757|192|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0757|193|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0757|194|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0757|195|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0757|196|I|cetirizine, diphenhydramine).||
0757|197|I|   Check the labels on all your medicines (such as allergy or||
0757|198|I|cough-and-cold products) because they may contain ingredients||
0757|199|I|that cause drowsiness. Ask your pharmacist about using those||
0757|200|I|products safely.||
0757|201|I|   This medication may interfere with certain lab tests (such as||
0757|202|I|amylase and lipase levels), possibly causing false test results.||
0757|203|I|Make sure lab personnel and all your doctors know you use this||
0757|204|I|drug.||
0757|205|B|||
0757|206|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0757|207|O|has overdosed and has serious symptoms such as passing out or||
0757|208|O|trouble breathing, give them naloxone or nalmefene if available,||
0757|209|O|then call 911. If the person is awake and has no symptoms, call a||
0757|210|O|poison control center right away. US residents can call||
0757|211|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0757|212|O|Symptoms of overdose may include: slow/shallow breathing, slow||
0757|213|O|heartbeat, extreme drowsiness, coma.||
0757|214|B|||
0757|215|N|NOTES:  Do not share this medication with others. Sharing it is||
0757|216|N|against the law.||
0757|217|N|   This medication has been prescribed for your current condition||
0757|218|N|only. Do not use it later for another condition unless told to do||
0757|219|N|so by your doctor. A different medication may be necessary in||
0757|220|N|that case.||
0757|221|B|||
0757|222|D|MISSED DOSE:  If you use this medication regularly and miss a||
0757|223|D|dose, use it as soon as you remember. If it is near the time of||
0757|224|D|the next dose, skip the missed dose. Use your next dose at the||
0757|225|D|regular time. Do not double the dose to catch up.||
0757|226|B|||
0757|227|R|STORAGE:  Store at room temperature away from heat. Keep all||
0757|228|R|medications away from children and pets.||
0757|229|R|   Do not flush medications down the toilet or pour them into a||
0757|230|R|drain unless instructed to do so. Properly discard this product||
0757|231|R|when it is expired or no longer needed. Consult your pharmacist||
0757|232|R|or local waste disposal company.||
0757|233|B|||
0757|234|A|Information last revised August 2025.||
0757|235|A|Copyright(c) 2025 First Databank, Inc.||
0757|236|B|||
0760|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0760|002|Z|does NOT have all possible information about this product. This||
0760|003|Z|information does not assure that this product is safe, effective,||
0760|004|Z|or appropriate for you. This information is not individual||
0760|005|Z|medical advice and does not substitute for the advice of your||
0760|006|Z|health care professional. Always ask your health care||
0760|007|Z|professional for complete information about this product and your||
0760|008|Z|specific health needs.||
0760|009|B|||
0760|010|T|LEUPROLIDE 6 MONTH (42 or 45 MG) - SUBCUTANEOUS INJECTION||
0760|011|F|(LOO-proe-lide)||
0760|012|B|||
0760|013|C|COMMON BRAND NAME(S): Camcevi, Eligard||
0760|014|B|||
0760|015|U|USES:  Leuprolide is used to treat advanced prostate cancer. It||
0760|016|U|is not a cure. Most types of prostate cancer need the hormone||
0760|017|U|testosterone to grow and spread. Leuprolide works by reducing the||
0760|018|U|amount of testosterone that the body makes. This helps slow or||
0760|019|U|stop the growth of cancer cells and helps relieve symptoms such||
0760|020|U|as painful/difficult urination. Talk to your doctor about the||
0760|021|U|risks and benefits of treatment.||
0760|022|U|   Some brands of this medication are also used to stop early||
0760|023|U|puberty (precocious puberty) in children. It helps to delay||
0760|024|U|sexual development (such as growth of the breasts/testicles) and||
0760|025|U|the start of menstrual periods. It also helps slow down early||
0760|026|U|bone growth to increase the likelihood of reaching normal adult||
0760|027|U|height. Leuprolide works by decreasing the amount of sex hormones||
0760|028|U|that a child's body makes (estrogen in girls, testosterone in||
0760|029|U|boys).||
0760|030|B|||
0760|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0760|032|H|from your pharmacist before you start using leuprolide and each||
0760|033|H|time you get a refill. If you have any questions, ask your doctor||
0760|034|H|or pharmacist.||
0760|035|H|   This medication is given by injection under the skin by a||
0760|036|H|health care professional as directed by the doctor, usually every||
0760|037|H|6 months. This product slowly releases the medication into the||
0760|038|H|blood over a 6-month period.||
0760|039|H|   Use this medication regularly to get the most benefit from it.||
0760|040|H|To help you remember, mark your calendar with a reminder.||
0760|041|H|   During the first few weeks of treatment, your hormone levels||
0760|042|H|will actually go up before they go down. This is a normal||
0760|043|H|response to this medication. Your symptoms may get worse for a||
0760|044|H|few weeks.||
0760|045|H|   If you have prostate cancer that has spread to the spine or||
0760|046|H|caused urinary blockage, you may require closer monitoring by||
0760|047|H|your doctor, especially when you first start treatment. Tell your||
0760|048|H|doctor right away if you have any bone pain,||
0760|049|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
0760|050|H|painful/difficult urination, unusual weakness, or inability to||
0760|051|H|move.||
0760|052|H|   If you are using this medication to stop early puberty, you||
0760|053|H|may notice worsening symptoms (such as menstrual periods) at the||
0760|054|H|start of treatment. However, you should see an improvement in||
0760|055|H|symptoms usually within 1 to 2 months. Tell the doctor promptly||
0760|056|H|if new or worsened symptoms develop after starting treatment.||
0760|057|B|||
0760|058|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
0760|059|S|sweats, tiredness, swelling of the ankles/feet, increased||
0760|060|S|urination at night, dizziness, or mild burning/pain/bruising at||
0760|061|S|the injection site may occur. If any of these effects last or get||
0760|062|S|worse, tell your doctor or pharmacist promptly.||
0760|063|S|   Rarely in men, shrinking of the testicles, breast||
0760|064|S|tenderness/swelling, or reduced sexual interest/ability may also||
0760|065|S|occur as a result of lowered testosterone levels. Talk to your||
0760|066|S|doctor if these effects occur.||
0760|067|S|   In girls, when this medication is used regularly, it is||
0760|068|S|expected that the menstrual period will stop or decrease to light||
0760|069|S|bleeding/spotting during the first 2 months. Tell the doctor||
0760|070|S|promptly if regular periods continue after 2 months of treatment||
0760|071|S|with leuprolide.||
0760|072|S|   Remember that this medication has been prescribed because your||
0760|073|S|doctor has judged that the benefit to you is greater than the||
0760|074|S|risk of side effects. Many people using this medication do not||
0760|075|S|have serious side effects.||
0760|076|S|   Tell your doctor right away if you have any serious side||
0760|077|S|effects, including: new/worsening bone pain (in adults), easily||
0760|078|S|broken bones (in adults), increased thirst/urination (in adults),||
0760|079|S|mental/mood changes (such as depression, thoughts of suicide,||
0760|080|S|mood swings, aggression).||
0760|081|S|   In adults, leuprolide may rarely cause serious liver disease.||
0760|082|S|Tell your doctor right away if you develop signs of liver||
0760|083|S|disease, such as nausea/vomiting that doesn't stop, loss of||
0760|084|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0760|085|S|urine.||
0760|086|S|   In adults, this medication may rarely cause heart problems and||
0760|087|S|stroke. Get medical help right away if any of these very serious||
0760|088|S|side effects occur: symptoms of a heart attack (such as||
0760|089|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
0760|090|S|signs of a stroke (such as weakness on one side of the body,||
0760|091|S|trouble speaking, sudden vision changes, confusion),||
0760|092|S|fast/irregular heartbeat, severe dizziness, fainting.||
0760|093|S|   Get medical help right away if you have any very serious side||
0760|094|S|effects, including: seizures.||
0760|095|S|   Children using leuprolide may rarely be at risk for increased||
0760|096|S|pressure around the brain (intracranial hypertension). Get||
0760|097|S|medical help right away if any of these very serious side effects||
0760|098|S|occur: nausea/vomiting that doesn't stop, headache that is severe||
0760|099|S|or doesn't go away, eye pain, vision changes (such as||
0760|100|S|blurred/double vision, decreased vision), ringing in the ears.||
0760|101|S|   A very serious allergic reaction to this drug is rare.||
0760|102|S|However, get medical help right away if you notice any symptoms||
0760|103|S|of a serious allergic reaction, including: fever, swollen lymph||
0760|104|S|nodes, rash, itching/swelling (especially of the||
0760|105|S|face/tongue/throat), severe dizziness, trouble breathing.||
0760|106|S|   This is not a complete list of possible side effects. If you||
0760|107|S|notice other effects not listed above, contact your doctor or||
0760|108|S|pharmacist.||
0760|109|S|   In the US -||
0760|110|S|   Call your doctor for medical advice about side effects. You||
0760|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0760|112|S|www.fda.gov/medwatch.||
0760|113|S|   In Canada - Call your doctor for medical advice about side||
0760|114|S|effects. You may report side effects to Health Canada at||
0760|115|S|1-866-234-2345.||
0760|116|B|||
0760|117|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
0760|118|P|pharmacist if you are allergic to it; or to similar drugs (such||
0760|119|P|as histrelin, triptorelin); or if you have any other allergies.||
0760|120|P|This product may contain inactive ingredients, which can cause||
0760|121|P|allergic reactions or other problems. Talk to your pharmacist for||
0760|122|P|more details.||
0760|123|P|   Before using this medication, tell your doctor or pharmacist||
0760|124|P|your medical history, especially of: diabetes, heart disease||
0760|125|P|(such as heart attack), stroke, high cholesterol, mental/mood||
0760|126|P|problems (such as depression), seizures.||
0760|127|P|   In adults, leuprolide may weaken your bones and increase your||
0760|128|P|risk for bone loss (osteoporosis) if used for a long time. Before||
0760|129|P|using this medication, tell your doctor or pharmacist if you have||
0760|130|P|osteoporosis or if you have any of the following risk factors for||
0760|131|P|osteoporosis: long-term alcohol use, smoking, family history of||
0760|132|P|osteoporosis and broken bones, use of certain medications (for||
0760|133|P|example, corticosteroids such as prednisone, certain anti-seizure||
0760|134|P|drugs such as phenytoin).||
0760|135|P|   In adults, leuprolide may cause a condition that affects the||
0760|136|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
0760|137|P|serious (rarely fatal) fast/irregular heartbeat and other||
0760|138|P|symptoms (such as severe dizziness, fainting) that need medical||
0760|139|P|attention right away.||
0760|140|P|   The risk of QT prolongation may be increased if you have||
0760|141|P|certain medical conditions or are taking other drugs that may||
0760|142|P|cause QT prolongation. Before using leuprolide, tell your doctor||
0760|143|P|or pharmacist of all the drugs you take and if you have any of||
0760|144|P|the following conditions: certain heart problems (heart failure,||
0760|145|P|slow heartbeat, QT prolongation in the EKG), family history of||
0760|146|P|certain heart problems (QT prolongation in the EKG, sudden||
0760|147|P|cardiac death).||
0760|148|P|   Low levels of potassium or magnesium in the blood may also||
0760|149|P|increase your risk of QT prolongation. This risk may increase if||
0760|150|P|you use certain drugs (such as diuretics/"water pills") or if you||
0760|151|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0760|152|P|Talk to your doctor about using leuprolide safely.||
0760|153|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0760|154|P|can make you more dizzy. Do not drive, use machinery, or do||
0760|155|P|anything that needs alertness until you can do it safely. Limit||
0760|156|P|alcoholic beverages. Talk to your doctor if you are using||
0760|157|P|marijuana (cannabis).||
0760|158|P|   Before having surgery, tell your doctor or dentist about all||
0760|159|P|the products you use (including prescription drugs,||
0760|160|P|nonprescription drugs, and herbal products).||
0760|161|P|   Older adults may be more sensitive to the side effects of this||
0760|162|P|drug, especially QT prolongation (see above).||
0760|163|P|   This medication can affect fertility in males. Ask your doctor||
0760|164|P|for more details.||
0760|165|P|   This medication must not be used during pregnancy. It may harm||
0760|166|P|an unborn baby. It is important to prevent pregnancy while using||
0760|167|P|this medication. Consult your doctor for more details and to||
0760|168|P|discuss using reliable forms of non-hormonal birth control (such||
0760|169|P|as condoms, diaphragm with spermicide) while using this||
0760|170|P|medication. If you become pregnant or think you may be pregnant,||
0760|171|P|tell your doctor right away.||
0760|172|P|   It is unknown if leuprolide passes into breast milk. Because||
0760|173|P|of the possible risk to the infant, breastfeeding is not||
0760|174|P|recommended while using this medication. Consult your doctor||
0760|175|P|before breastfeeding.||
0760|176|B|||
0760|177|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0760|178|I|medications work or increase your risk for serious side effects.||
0760|179|I|This document does not contain all possible drug interactions.||
0760|180|I|Keep a list of all the products you use (including||
0760|181|I|prescription/nonprescription drugs and herbal products) and share||
0760|182|I|it with your doctor and pharmacist. Do not start, stop, or change||
0760|183|I|the dosage of any medicines without your doctor's approval.||
0760|184|I|   This medication may interfere with certain lab tests, possibly||
0760|185|I|causing false test results. Make sure lab personnel and all your||
0760|186|I|doctors know you use this drug.||
0760|187|B|||
0760|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0760|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0760|190|O|poison control center right away. US residents can call||
0760|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0760|192|B|||
0760|193|N|NOTES:  Do not share this medication with others.||
0760|194|N|   Lab and/or medical tests (such as hormone levels, PSA blood||
0760|195|N|test for men, blood glucose, cholesterol/triglyceride levels,||
0760|196|N|height measurements and bone tests in children) should be done||
0760|197|N|while you are using this medication. Keep all medical and lab||
0760|198|N|appointments. Consult your doctor for more details.||
0760|199|B|||
0760|200|D|MISSED DOSE:  It is important to get each dose of this medication||
0760|201|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
0760|202|D|right away for a new dosing schedule. Do not double the dose to||
0760|203|D|catch up.||
0760|204|B|||
0760|205|R|STORAGE:  Not applicable. This medication is given in a clinic or||
0760|206|R|doctor's office and will not be stored at home.||
0760|207|B|||
0760|208|A|Information last revised October 2024.||
0760|209|A|Copyright(c) 2025 First Databank, Inc.||
0760|210|B|||
0762|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0762|002|Z|does NOT have all possible information about this product. This||
0762|003|Z|information does not assure that this product is safe, effective,||
0762|004|Z|or appropriate for you. This information is not individual||
0762|005|Z|medical advice and does not substitute for the advice of your||
0762|006|Z|health care professional. Always ask your health care||
0762|007|Z|professional for complete information about this product and your||
0762|008|Z|specific health needs.||
0762|009|B|||
0762|010|T|KERATOLYTIC EMOLLIENTS - TOPICAL||
0762|011|B|||
0762|012|U|USES:  This medication has 2 types of ingredients (emollient,||
0762|013|U|keratolytic) that work together to treat or prevent dry, rough,||
0762|014|U|scaly, itchy skin (such as that caused by eczema, keratosis,||
0762|015|U|xerosis). Dry skin is caused by a loss of water in the upper||
0762|016|U|layer of the skin. Emollients are substances that soften and||
0762|017|U|moisturize the skin and decrease itching and flaking.||
0762|018|U|Emollients/moisturizers work by forming an oily layer on the top||
0762|019|U|of the skin that traps water in the skin. Petrolatum, lanolin,||
0762|020|U|mineral oil, and dimethicone are common emollients.||
0762|021|U|   Lactic acid, salicylic acid, and urea are keratolytics. They||
0762|022|U|increase moisture in the skin by softening/dissolving the horny||
0762|023|U|substance (keratin) holding the top layer of skin cells together.||
0762|024|U|This helps the dead skin cells fall off and helps the skin keep||
0762|025|U|more water in. Higher strengths of urea are used to treat corns,||
0762|026|U|callous, and some nail problems (such as ingrown nails). Urea is||
0762|027|U|also used to help remove dead tissue in some wounds to help wound||
0762|028|U|healing.||
0762|029|B|||
0762|030|H|HOW TO USE:  Use this product as directed. Follow all directions||
0762|031|H|on the product package and prescription label. If you have any||
0762|032|H|questions, ask your doctor or pharmacist.||
0762|033|H|   Some products need to be shaken before use. Check the label to||
0762|034|H|see if you should shake the bottle well before using. Apply to||
0762|035|H|the affected areas of the skin, usually 1 to 3 times a day or as||
0762|036|H|directed by your doctor. Rub in well until absorbed. How often||
0762|037|H|you apply the medication will depend on the product and your skin||
0762|038|H|condition.||
0762|039|H|   Apply to the skin/nails only. Avoid sensitive areas such as||
0762|040|H|your eyes, lips, inside your mouth/nose, and the vaginal/groin||
0762|041|H|area, unless your doctor directs you otherwise. Ask your doctor||
0762|042|H|or check the label for directions about any areas or types of||
0762|043|H|skin where you should not apply the product (such as on the face,||
0762|044|H|any areas of broken/chapped/cut/irritated/scraped skin, or on a||
0762|045|H|recently shaved area of the skin). Consult your doctor or||
0762|046|H|pharmacist for more details.||
0762|047|H|   Use this medication regularly to get the most benefit from it.||
0762|048|H|Most moisturizers need water to work well. Apply the product||
0762|049|H|after bathing/showering/shampooing while the skin is still damp.||
0762|050|H|For very dry skin, your doctor may instruct you to soak the area||
0762|051|H|before using the product. Long, hot, or frequent bathing/washing||
0762|052|H|can worsen dry skin.||
0762|053|H|   Tell your doctor if your condition lasts or gets worse.||
0762|054|B|||
0762|055|S|SIDE EFFECTS:  Burning, itching, stinging, redness, or irritation||
0762|056|S|may occur. If any of these effects last or get worse, tell your||
0762|057|S|doctor or pharmacist promptly.||
0762|058|S|   If your doctor has directed you to use this medication,||
0762|059|S|remember that your doctor has judged that the benefit to you is||
0762|060|S|greater than the risk of side effects. Many people using this||
0762|061|S|medication do not have serious side effects.||
0762|062|S|   Tell your doctor right away if you have any serious side||
0762|063|S|effects, including: unusual changes in the skin (such as||
0762|064|S|blistering, peeling, turning white/soft/soggy from too much||
0762|065|S|wetness), signs of skin infection.||
0762|066|S|   A very serious allergic reaction to this drug is rare.||
0762|067|S|However, get medical help right away if you notice any symptoms||
0762|068|S|of a serious allergic reaction, including: rash, itching/swelling||
0762|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0762|070|S|breathing.||
0762|071|S|   This is not a complete list of possible side effects. If you||
0762|072|S|notice other effects not listed above, contact your doctor or||
0762|073|S|pharmacist.||
0762|074|S|   In the US -||
0762|075|S|   Call your doctor for medical advice about side effects. You||
0762|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0762|077|S|www.fda.gov/medwatch.||
0762|078|S|   In Canada - Call your doctor for medical advice about side||
0762|079|S|effects. You may report side effects to Health Canada at||
0762|080|S|1-866-234-2345.||
0762|081|B|||
0762|082|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0762|083|P|pharmacist if you are allergic to any of the ingredients (such as||
0762|084|P|urea, lactic acid) in the product; or if you have any other||
0762|085|P|allergies. This product may contain inactive ingredients, which||
0762|086|P|can cause allergic reactions or other problems. Talk to your||
0762|087|P|pharmacist for more details.||
0762|088|P|   Before using this medication, tell your doctor or pharmacist||
0762|089|P|your medical history, especially of: skin cuts/infections/sores.||
0762|090|P|   This medication may make you more sensitive to the sun. Check||
0762|091|P|the label for any warnings or ask your doctor or pharmacist if||
0762|092|P|you need to take any special precautions when in the sun. Your||
0762|093|P|doctor/pharmacist may suggest that you limit your time in the||
0762|094|P|sun, avoid tanning booths and sunlamps, and use sunscreen and||
0762|095|P|wear protective clothing when outdoors. Tell your doctor right||
0762|096|P|away if you get sunburned or have skin blisters/redness.||
0762|097|P|   Some products may stain/discolor clothing. Ask your doctor or||
0762|098|P|pharmacist for more details.||
0762|099|P|   During pregnancy, this medication should be used only when||
0762|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0762|101|P|   It is unknown if this product passes into breast milk. Consult||
0762|102|P|your doctor before breastfeeding.||
0762|103|B|||
0762|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0762|105|I|medications work or increase your risk for serious side effects.||
0762|106|I|This document does not contain all possible drug interactions.||
0762|107|I|Keep a list of all the products you use (including||
0762|108|I|prescription/nonprescription drugs and herbal products) and share||
0762|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
0762|110|I|the dosage of any medicines without your doctor's approval.||
0762|111|B|||
0762|112|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0762|113|O|has overdosed and has serious symptoms such as passing out or||
0762|114|O|trouble breathing, call 911. Otherwise, call a poison control||
0762|115|O|center right away. US residents can call 1-800-222-1222. Canada||
0762|116|O|residents can call 1-844-764-7669.||
0762|117|B|||
0762|118|N|NOTES:  Do not share this medication with others.||
0762|119|N|   Some ways to help prevent dry skin include using lukewarm (not||
0762|120|N|hot) water when bathing, taking baths/showers less often (such as||
0762|121|N|every 1 to 2 days), keeping baths/showers short, and using a||
0762|122|N|humidifier when the air is very dry.||
0762|123|B|||
0762|124|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0762|125|D|If it is near the time of the next dose, skip the missed dose.||
0762|126|D|Use your next dose at the regular time. Do not use more often to||
0762|127|D|catch up.||
0762|128|B|||
0762|129|R|STORAGE:  Store at room temperature. Do not freeze. Some products||
0762|130|R|(such as foams) may be flammable. Keep those products away from||
0762|131|R|heat and open flame. Keep all medications away from children and||
0762|132|R|pets.||
0762|133|R|   Do not flush medications down the toilet or pour them into a||
0762|134|R|drain unless instructed to do so. Properly discard this product||
0762|135|R|when it is expired or no longer needed. Consult your pharmacist||
0762|136|R|or local waste disposal company.||
0762|137|B|||
0762|138|A|Information last revised July 2025.||
0762|139|A|Copyright(c) 2025 First Databank, Inc.||
0762|140|B|||
0763|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0763|002|Z|does NOT have all possible information about this product. This||
0763|003|Z|information does not assure that this product is safe, effective,||
0763|004|Z|or appropriate for you. This information is not individual||
0763|005|Z|medical advice and does not substitute for the advice of your||
0763|006|Z|health care professional. Always ask your health care||
0763|007|Z|professional for complete information about this product and your||
0763|008|Z|specific health needs.||
0763|009|B|||
0763|010|T|LEUPROLIDE MONTHLY (7.5 MG) - INTRAMUSCULAR INJECTION||
0763|011|F|(LOO-proe-lide)||
0763|012|B|||
0763|013|C|COMMON BRAND NAME(S): Lupron Depot||
0763|014|B|||
0763|015|U|USES:  Leuprolide is used to treat advanced prostate cancer. It||
0763|016|U|is not a cure. Most types of prostate cancer need the hormone||
0763|017|U|testosterone to grow and spread. Leuprolide works by reducing the||
0763|018|U|amount of testosterone that the body makes. This helps slow or||
0763|019|U|stop the growth of cancer cells and helps relieve symptoms such||
0763|020|U|as painful/difficult urination. Talk to your doctor about the||
0763|021|U|risks and benefits of treatment.||
0763|022|B|||
0763|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0763|024|H|from your pharmacist before you start using leuprolide and each||
0763|025|H|time you get a refill. If you have any questions, ask your doctor||
0763|026|H|or pharmacist.||
0763|027|H|   This medication is given by injection into a muscle by a||
0763|028|H|health care professional. It is given as directed by your doctor,||
0763|029|H|usually once a month (every 4 weeks). This product slowly||
0763|030|H|releases the medication into your blood over a 1-month period.||
0763|031|H|   Use this medication regularly to get the most benefit from it.||
0763|032|H|To help you remember, mark your calendar with a reminder.||
0763|033|H|   During the first few weeks of treatment, your hormone levels||
0763|034|H|will actually go up before they go down. This is a normal||
0763|035|H|response to this medication. Your symptoms may get worse for a||
0763|036|H|few weeks. If you have prostate cancer that has spread to the||
0763|037|H|spine or caused urinary blockage, you may require closer||
0763|038|H|monitoring by your doctor, especially when you first start||
0763|039|H|treatment. Tell your doctor right away if you have any bone pain,||
0763|040|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
0763|041|H|painful/difficult urination, unusual weakness, or inability to||
0763|042|H|move.||
0763|043|B|||
0763|044|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
0763|045|S|sweats, tiredness, swelling of the ankles/feet, increased||
0763|046|S|urination at night, dizziness, or mild burning/pain/bruising at||
0763|047|S|the injection site may occur. If any of these effects last or get||
0763|048|S|worse, tell your doctor or pharmacist promptly.||
0763|049|S|   Rarely, shrinking of the testicles, breast||
0763|050|S|tenderness/swelling, or reduced sexual interest/ability may also||
0763|051|S|occur as a result of lowered testosterone levels. Talk to your||
0763|052|S|doctor if these effects occur.||
0763|053|S|   Remember that this medication has been prescribed because your||
0763|054|S|doctor has judged that the benefit to you is greater than the||
0763|055|S|risk of side effects. Many people using this medication do not||
0763|056|S|have serious side effects.||
0763|057|S|   Tell your doctor right away if you have any serious side||
0763|058|S|effects, including: new/worsening bone pain, easily broken bones,||
0763|059|S|increased thirst/urination, mental/mood changes (such as||
0763|060|S|depression, thoughts of suicide, mood swings, aggression), signs||
0763|061|S|of liver disease (such as nausea/vomiting that doesn't stop, loss||
0763|062|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0763|063|S|urine).||
0763|064|S|   Get medical help right away if you have any very serious side||
0763|065|S|effects, including: symptoms of a heart attack (such as||
0763|066|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
0763|067|S|signs of a stroke (such as weakness on one side of the body,||
0763|068|S|trouble speaking, sudden vision changes, confusion), seizures,||
0763|069|S|fast/irregular heartbeat, severe dizziness, fainting.||
0763|070|S|   A very serious allergic reaction to this drug is rare.||
0763|071|S|However, get medical help right away if you notice any symptoms||
0763|072|S|of a serious allergic reaction, including: fever, swollen lymph||
0763|073|S|nodes, rash, itching/swelling (especially of the||
0763|074|S|face/tongue/throat), severe dizziness, trouble breathing.||
0763|075|S|   This is not a complete list of possible side effects. If you||
0763|076|S|notice other effects not listed above, contact your doctor or||
0763|077|S|pharmacist.||
0763|078|S|   In the US -||
0763|079|S|   Call your doctor for medical advice about side effects. You||
0763|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0763|081|S|www.fda.gov/medwatch.||
0763|082|S|   In Canada - Call your doctor for medical advice about side||
0763|083|S|effects. You may report side effects to Health Canada at||
0763|084|S|1-866-234-2345.||
0763|085|B|||
0763|086|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
0763|087|P|pharmacist if you are allergic to it; or to similar drugs (such||
0763|088|P|as histrelin, triptorelin); or if you have any other allergies.||
0763|089|P|This product may contain inactive ingredients, which can cause||
0763|090|P|allergic reactions or other problems. Talk to your pharmacist for||
0763|091|P|more details.||
0763|092|P|   Before using this medication, tell your doctor or pharmacist||
0763|093|P|your medical history, especially of: diabetes, heart disease||
0763|094|P|(such as heart attack), stroke, high cholesterol, mental/mood||
0763|095|P|problems (such as depression), seizures.||
0763|096|P|   Leuprolide may weaken your bones and increase your risk for||
0763|097|P|bone loss (osteoporosis) if used for a long time. Before using||
0763|098|P|this medication, tell your doctor or pharmacist if you have||
0763|099|P|osteoporosis or if you have any of the following risk factors for||
0763|100|P|osteoporosis: long-term alcohol use, smoking, family history of||
0763|101|P|osteoporosis and broken bones, use of certain medications (for||
0763|102|P|example, corticosteroids such as prednisone, certain anti-seizure||
0763|103|P|drugs such as phenytoin).||
0763|104|P|   Leuprolide may cause a condition that affects the heart rhythm||
0763|105|P|(QT prolongation). QT prolongation can rarely cause serious||
0763|106|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0763|107|P|as severe dizziness, fainting) that need medical attention right||
0763|108|P|away.||
0763|109|P|   The risk of QT prolongation may be increased if you have||
0763|110|P|certain medical conditions or are taking other drugs that may||
0763|111|P|cause QT prolongation. Before using leuprolide, tell your doctor||
0763|112|P|or pharmacist of all the drugs you take and if you have any of||
0763|113|P|the following conditions: certain heart problems (heart failure,||
0763|114|P|slow heartbeat, QT prolongation in the EKG), family history of||
0763|115|P|certain heart problems (QT prolongation in the EKG, sudden||
0763|116|P|cardiac death).||
0763|117|P|   Low levels of potassium or magnesium in the blood may also||
0763|118|P|increase your risk of QT prolongation. This risk may increase if||
0763|119|P|you use certain drugs (such as diuretics/"water pills") or if you||
0763|120|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0763|121|P|Talk to your doctor about using leuprolide safely.||
0763|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0763|123|P|can make you more dizzy. Do not drive, use machinery, or do||
0763|124|P|anything that needs alertness until you can do it safely. Limit||
0763|125|P|alcoholic beverages. Talk to your doctor if you are using||
0763|126|P|marijuana (cannabis).||
0763|127|P|   Before having surgery, tell your doctor or dentist about all||
0763|128|P|the products you use (including prescription drugs,||
0763|129|P|nonprescription drugs, and herbal products).||
0763|130|P|   Older adults may be more sensitive to the side effects of this||
0763|131|P|drug, especially QT prolongation (see above).||
0763|132|P|   This medication can affect fertility in males. Ask your doctor||
0763|133|P|for more details.||
0763|134|P|   This medication must not be used during pregnancy. It may harm||
0763|135|P|an unborn baby. It is important to prevent pregnancy while using||
0763|136|P|this medication. Consult your doctor for more details and to||
0763|137|P|discuss using reliable forms of non-hormonal birth control (such||
0763|138|P|as condoms, diaphragm with spermicide) while using this||
0763|139|P|medication. If you become pregnant or think you may be pregnant,||
0763|140|P|tell your doctor right away.||
0763|141|P|   It is unknown if leuprolide passes into breast milk. Because||
0763|142|P|of the possible risk to the infant, breastfeeding is not||
0763|143|P|recommended while using this medication. Consult your doctor||
0763|144|P|before breastfeeding.||
0763|145|B|||
0763|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0763|147|I|medications work or increase your risk for serious side effects.||
0763|148|I|This document does not contain all possible drug interactions.||
0763|149|I|Keep a list of all the products you use (including||
0763|150|I|prescription/nonprescription drugs and herbal products) and share||
0763|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
0763|152|I|the dosage of any medicines without your doctor's approval.||
0763|153|I|   This medication may interfere with certain lab tests, possibly||
0763|154|I|causing false test results. Make sure lab personnel and all your||
0763|155|I|doctors know you use this drug.||
0763|156|B|||
0763|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0763|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0763|159|O|poison control center right away. US residents can call||
0763|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0763|161|B|||
0763|162|N|NOTES:  Do not share this medication with others.||
0763|163|N|   Lab and/or medical tests (such as blood testosterone level,||
0763|164|N|PSA blood test, blood glucose, cholesterol/triglyceride levels)||
0763|165|N|should be done while you are using this medication. Keep all||
0763|166|N|medical and lab appointments. Consult your doctor for more||
0763|167|N|details.||
0763|168|B|||
0763|169|D|MISSED DOSE:  It is important to get each dose of this medication||
0763|170|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
0763|171|D|right away for a new dosing schedule. Do not double the dose to||
0763|172|D|catch up.||
0763|173|B|||
0763|174|R|STORAGE:  Not applicable. This medication is given in a clinic or||
0763|175|R|doctor's office and will not be stored at home.||
0763|176|B|||
0763|177|A|Information last revised October 2024.||
0763|178|A|Copyright(c) 2025 First Databank, Inc.||
0763|179|B|||
0764|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0764|002|Z|does NOT have all possible information about this product. This||
0764|003|Z|information does not assure that this product is safe, effective,||
0764|004|Z|or appropriate for you. This information is not individual||
0764|005|Z|medical advice and does not substitute for the advice of your||
0764|006|Z|health care professional. Always ask your health care||
0764|007|Z|professional for complete information about this product and your||
0764|008|Z|specific health needs.||
0764|009|B|||
0764|010|T|LEUPROLIDE 3 MONTH (22.5 MG) - INTRAMUSCULAR INJECTION||
0764|011|F|(LOO-proe-lide)||
0764|012|B|||
0764|013|C|COMMON BRAND NAME(S): Lupron Depot||
0764|014|B|||
0764|015|U|USES:  Leuprolide is used to treat advanced prostate cancer. It||
0764|016|U|is not a cure. Most types of prostate cancer need the hormone||
0764|017|U|testosterone to grow and spread. Leuprolide works by reducing the||
0764|018|U|amount of testosterone that the body makes. This helps slow or||
0764|019|U|stop the growth of cancer cells and helps relieve symptoms such||
0764|020|U|as painful/difficult urination. Talk to your doctor about the||
0764|021|U|risks and benefits of treatment.||
0764|022|B|||
0764|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0764|024|H|from your pharmacist before you start using leuprolide and each||
0764|025|H|time you get a refill. If you have any questions, ask your doctor||
0764|026|H|or pharmacist.||
0764|027|H|   This medication is given by injection into a muscle by a||
0764|028|H|health care professional. It is given as directed by your doctor,||
0764|029|H|usually once every 3 months (every 12 weeks). This product slowly||
0764|030|H|releases the medication into your blood over a 3-month period.||
0764|031|H|   Use this medication regularly to get the most benefit from it.||
0764|032|H|To help you remember, mark your calendar with a reminder.||
0764|033|H|   During the first few weeks of treatment, your hormone levels||
0764|034|H|will actually go up before they go down. This is a normal||
0764|035|H|response to this medication. Your symptoms may get worse for a||
0764|036|H|few weeks. If you have prostate cancer that has spread to the||
0764|037|H|spine or caused urinary blockage, you may require closer||
0764|038|H|monitoring by your doctor, especially when you first start||
0764|039|H|treatment. Tell your doctor right away if you have any bone pain,||
0764|040|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
0764|041|H|painful/difficult urination, unusual weakness, or inability to||
0764|042|H|move.||
0764|043|B|||
0764|044|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
0764|045|S|sweats, tiredness, swelling of the ankles/feet, increased||
0764|046|S|urination at night, dizziness, or mild burning/pain/bruising at||
0764|047|S|the injection site may occur. If any of these effects last or get||
0764|048|S|worse, tell your doctor or pharmacist promptly.||
0764|049|S|   Rarely, shrinking of the testicles, breast||
0764|050|S|tenderness/swelling, or reduced sexual interest/ability may also||
0764|051|S|occur as a result of lowered testosterone levels. Talk to your||
0764|052|S|doctor if these effects occur.||
0764|053|S|   Remember that this medication has been prescribed because your||
0764|054|S|doctor has judged that the benefit to you is greater than the||
0764|055|S|risk of side effects. Many people using this medication do not||
0764|056|S|have serious side effects.||
0764|057|S|   Tell your doctor right away if you have any serious side||
0764|058|S|effects, including: new/worsening bone pain, easily broken bones,||
0764|059|S|increased thirst/urination, mental/mood changes (such as||
0764|060|S|depression, thoughts of suicide, mood swings, aggression), signs||
0764|061|S|of liver disease (such as nausea/vomiting that doesn't stop, loss||
0764|062|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0764|063|S|urine).||
0764|064|S|   Get medical help right away if you have any very serious side||
0764|065|S|effects, including: symptoms of a heart attack (such as||
0764|066|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
0764|067|S|signs of a stroke (such as weakness on one side of the body,||
0764|068|S|trouble speaking, sudden vision changes, confusion), seizures,||
0764|069|S|fast/irregular heartbeat, severe dizziness, fainting.||
0764|070|S|   A very serious allergic reaction to this drug is rare.||
0764|071|S|However, get medical help right away if you notice any symptoms||
0764|072|S|of a serious allergic reaction, including: fever, swollen lymph||
0764|073|S|nodes, rash, itching/swelling (especially of the||
0764|074|S|face/tongue/throat), severe dizziness, trouble breathing.||
0764|075|S|   This is not a complete list of possible side effects. If you||
0764|076|S|notice other effects not listed above, contact your doctor or||
0764|077|S|pharmacist.||
0764|078|S|   In the US -||
0764|079|S|   Call your doctor for medical advice about side effects. You||
0764|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0764|081|S|www.fda.gov/medwatch.||
0764|082|S|   In Canada - Call your doctor for medical advice about side||
0764|083|S|effects. You may report side effects to Health Canada at||
0764|084|S|1-866-234-2345.||
0764|085|B|||
0764|086|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
0764|087|P|pharmacist if you are allergic to it; or to similar drugs (such||
0764|088|P|as histrelin, triptorelin); or if you have any other allergies.||
0764|089|P|This product may contain inactive ingredients, which can cause||
0764|090|P|allergic reactions or other problems. Talk to your pharmacist for||
0764|091|P|more details.||
0764|092|P|   Before using this medication, tell your doctor or pharmacist||
0764|093|P|your medical history, especially of: diabetes, heart disease||
0764|094|P|(such as heart attack), stroke, high cholesterol, mental/mood||
0764|095|P|problems (such as depression), seizures.||
0764|096|P|   Leuprolide may weaken your bones and increase your risk for||
0764|097|P|bone loss (osteoporosis) if used for a long time. Before using||
0764|098|P|this medication, tell your doctor or pharmacist if you have||
0764|099|P|osteoporosis or if you have any of the following risk factors for||
0764|100|P|osteoporosis: long-term alcohol use, smoking, family history of||
0764|101|P|osteoporosis and broken bones, use of certain medications (for||
0764|102|P|example, corticosteroids such as prednisone, certain anti-seizure||
0764|103|P|drugs such as phenytoin).||
0764|104|P|   Leuprolide may cause a condition that affects the heart rhythm||
0764|105|P|(QT prolongation). QT prolongation can rarely cause serious||
0764|106|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0764|107|P|as severe dizziness, fainting) that need medical attention right||
0764|108|P|away.||
0764|109|P|   The risk of QT prolongation may be increased if you have||
0764|110|P|certain medical conditions or are taking other drugs that may||
0764|111|P|cause QT prolongation. Before using leuprolide, tell your doctor||
0764|112|P|or pharmacist of all the drugs you take and if you have any of||
0764|113|P|the following conditions: certain heart problems (heart failure,||
0764|114|P|slow heartbeat, QT prolongation in the EKG), family history of||
0764|115|P|certain heart problems (QT prolongation in the EKG, sudden||
0764|116|P|cardiac death).||
0764|117|P|   Low levels of potassium or magnesium in the blood may also||
0764|118|P|increase your risk of QT prolongation. This risk may increase if||
0764|119|P|you use certain drugs (such as diuretics/"water pills") or if you||
0764|120|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0764|121|P|Talk to your doctor about using leuprolide safely.||
0764|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0764|123|P|can make you more dizzy. Do not drive, use machinery, or do||
0764|124|P|anything that needs alertness until you can do it safely. Limit||
0764|125|P|alcoholic beverages. Talk to your doctor if you are using||
0764|126|P|marijuana (cannabis).||
0764|127|P|   Before having surgery, tell your doctor or dentist about all||
0764|128|P|the products you use (including prescription drugs,||
0764|129|P|nonprescription drugs, and herbal products).||
0764|130|P|   Older adults may be more sensitive to the side effects of this||
0764|131|P|drug, especially QT prolongation (see above).||
0764|132|P|   This medication can affect fertility in males. Ask your doctor||
0764|133|P|for more details.||
0764|134|P|   This medication must not be used during pregnancy. It may harm||
0764|135|P|an unborn baby. It is important to prevent pregnancy while using||
0764|136|P|this medication. Consult your doctor for more details and to||
0764|137|P|discuss using reliable forms of non-hormonal birth control (such||
0764|138|P|as condoms, diaphragm with spermicide) while using this||
0764|139|P|medication. If you become pregnant or think you may be pregnant,||
0764|140|P|tell your doctor right away.||
0764|141|P|   It is unknown if leuprolide passes into breast milk. Because||
0764|142|P|of the possible risk to the infant, breastfeeding is not||
0764|143|P|recommended while using this medication. Consult your doctor||
0764|144|P|before breastfeeding.||
0764|145|B|||
0764|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0764|147|I|medications work or increase your risk for serious side effects.||
0764|148|I|This document does not contain all possible drug interactions.||
0764|149|I|Keep a list of all the products you use (including||
0764|150|I|prescription/nonprescription drugs and herbal products) and share||
0764|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
0764|152|I|the dosage of any medicines without your doctor's approval.||
0764|153|I|   This medication may interfere with certain lab tests, possibly||
0764|154|I|causing false test results. Make sure lab personnel and all your||
0764|155|I|doctors know you use this drug.||
0764|156|B|||
0764|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0764|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0764|159|O|poison control center right away. US residents can call||
0764|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0764|161|B|||
0764|162|N|NOTES:  Do not share this medication with others.||
0764|163|N|   Lab and/or medical tests (such as blood testosterone level,||
0764|164|N|PSA blood test, blood glucose, cholesterol/triglyceride levels)||
0764|165|N|should be done while you are using this medication. Keep all||
0764|166|N|medical and lab appointments. Consult your doctor for more||
0764|167|N|details.||
0764|168|B|||
0764|169|D|MISSED DOSE:  It is important to get each dose of this medication||
0764|170|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
0764|171|D|right away for a new dosing schedule. Do not double the dose to||
0764|172|D|catch up.||
0764|173|B|||
0764|174|R|STORAGE:  Not applicable. This medication is given in a clinic or||
0764|175|R|doctor's office and will not be stored at home.||
0764|176|B|||
0764|177|A|Information last revised October 2024.||
0764|178|A|Copyright(c) 2025 First Databank, Inc.||
0764|179|B|||
0765|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0765|002|Z|does NOT have all possible information about this product. This||
0765|003|Z|information does not assure that this product is safe, effective,||
0765|004|Z|or appropriate for you. This information is not individual||
0765|005|Z|medical advice and does not substitute for the advice of your||
0765|006|Z|health care professional. Always ask your health care||
0765|007|Z|professional for complete information about this product and your||
0765|008|Z|specific health needs.||
0765|009|B|||
0765|010|T|LEUPROLIDE 4 MONTH (30 MG) - INTRAMUSCULAR INJECTION||
0765|011|F|(LOO-proe-lide)||
0765|012|B|||
0765|013|C|COMMON BRAND NAME(S): Lupron Depot||
0765|014|B|||
0765|015|U|USES:  Leuprolide is used to treat advanced prostate cancer. It||
0765|016|U|is not a cure. Most types of prostate cancer need the hormone||
0765|017|U|testosterone to grow and spread. Leuprolide works by reducing the||
0765|018|U|amount of testosterone that the body makes. This helps slow or||
0765|019|U|stop the growth of cancer cells and helps relieve symptoms such||
0765|020|U|as painful/difficult urination. Talk to your doctor about the||
0765|021|U|risks and benefits of treatment.||
0765|022|B|||
0765|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0765|024|H|from your pharmacist before you start using leuprolide and each||
0765|025|H|time you get a refill. If you have any questions, ask your doctor||
0765|026|H|or pharmacist.||
0765|027|H|   This medication is given by injection into a muscle by a||
0765|028|H|health care professional. It is given as directed by your doctor,||
0765|029|H|usually once every 4 months (every 16 weeks). This product slowly||
0765|030|H|releases the medication into your blood over a 4-month period.||
0765|031|H|   Use this medication regularly to get the most benefit from it.||
0765|032|H|To help you remember, mark your calendar with a reminder.||
0765|033|H|   During the first few weeks of treatment, your hormone levels||
0765|034|H|will actually go up before they go down. This is a normal||
0765|035|H|response to this medication. Your symptoms may get worse for a||
0765|036|H|few weeks. If you have prostate cancer that has spread to the||
0765|037|H|spine or caused urinary blockage, you may require closer||
0765|038|H|monitoring by your doctor, especially when you first start||
0765|039|H|treatment. Tell your doctor right away if you have any bone pain,||
0765|040|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
0765|041|H|painful/difficult urination, unusual weakness, or inability to||
0765|042|H|move.||
0765|043|B|||
0765|044|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
0765|045|S|sweats, tiredness, swelling of the ankles/feet, increased||
0765|046|S|urination at night, dizziness, or mild burning/pain/bruising at||
0765|047|S|the injection site may occur. If any of these effects last or get||
0765|048|S|worse, tell your doctor or pharmacist promptly.||
0765|049|S|   Rarely, shrinking of the testicles, breast||
0765|050|S|tenderness/swelling, or reduced sexual interest/ability may also||
0765|051|S|occur as a result of lowered testosterone levels. Talk to your||
0765|052|S|doctor if these effects occur.||
0765|053|S|   Remember that this medication has been prescribed because your||
0765|054|S|doctor has judged that the benefit to you is greater than the||
0765|055|S|risk of side effects. Many people using this medication do not||
0765|056|S|have serious side effects.||
0765|057|S|   Tell your doctor right away if you have any serious side||
0765|058|S|effects, including: new/worsening bone pain, easily broken bones,||
0765|059|S|increased thirst/urination, mental/mood changes (such as||
0765|060|S|depression, thoughts of suicide, mood swings, aggression), signs||
0765|061|S|of liver disease (such as nausea/vomiting that doesn't stop, loss||
0765|062|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0765|063|S|urine).||
0765|064|S|   Get medical help right away if you have any very serious side||
0765|065|S|effects, including: symptoms of a heart attack (such as||
0765|066|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
0765|067|S|signs of a stroke (such as weakness on one side of the body,||
0765|068|S|trouble speaking, sudden vision changes, confusion), seizures,||
0765|069|S|fast/irregular heartbeat, severe dizziness, fainting.||
0765|070|S|   A very serious allergic reaction to this drug is rare.||
0765|071|S|However, get medical help right away if you notice any symptoms||
0765|072|S|of a serious allergic reaction, including: fever, swollen lymph||
0765|073|S|nodes, rash, itching/swelling (especially of the||
0765|074|S|face/tongue/throat), severe dizziness, trouble breathing.||
0765|075|S|   This is not a complete list of possible side effects. If you||
0765|076|S|notice other effects not listed above, contact your doctor or||
0765|077|S|pharmacist.||
0765|078|S|   In the US -||
0765|079|S|   Call your doctor for medical advice about side effects. You||
0765|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0765|081|S|www.fda.gov/medwatch.||
0765|082|S|   In Canada - Call your doctor for medical advice about side||
0765|083|S|effects. You may report side effects to Health Canada at||
0765|084|S|1-866-234-2345.||
0765|085|B|||
0765|086|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
0765|087|P|pharmacist if you are allergic to it; or to similar drugs (such||
0765|088|P|as histrelin, triptorelin); or if you have any other allergies.||
0765|089|P|This product may contain inactive ingredients, which can cause||
0765|090|P|allergic reactions or other problems. Talk to your pharmacist for||
0765|091|P|more details.||
0765|092|P|   Before using this medication, tell your doctor or pharmacist||
0765|093|P|your medical history, especially of: diabetes, heart disease||
0765|094|P|(such as heart attack), stroke, high cholesterol, mental/mood||
0765|095|P|problems (such as depression), seizures.||
0765|096|P|   Leuprolide may weaken your bones and increase your risk for||
0765|097|P|bone loss (osteoporosis) if used for a long time. Before using||
0765|098|P|this medication, tell your doctor or pharmacist if you have||
0765|099|P|osteoporosis or if you have any of the following risk factors for||
0765|100|P|osteoporosis: long-term alcohol use, smoking, family history of||
0765|101|P|osteoporosis and broken bones, use of certain medications (for||
0765|102|P|example, corticosteroids such as prednisone, certain anti-seizure||
0765|103|P|drugs such as phenytoin).||
0765|104|P|   Leuprolide may cause a condition that affects the heart rhythm||
0765|105|P|(QT prolongation). QT prolongation can rarely cause serious||
0765|106|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0765|107|P|as severe dizziness, fainting) that need medical attention right||
0765|108|P|away.||
0765|109|P|   The risk of QT prolongation may be increased if you have||
0765|110|P|certain medical conditions or are taking other drugs that may||
0765|111|P|cause QT prolongation. Before using leuprolide, tell your doctor||
0765|112|P|or pharmacist of all the drugs you take and if you have any of||
0765|113|P|the following conditions: certain heart problems (heart failure,||
0765|114|P|slow heartbeat, QT prolongation in the EKG), family history of||
0765|115|P|certain heart problems (QT prolongation in the EKG, sudden||
0765|116|P|cardiac death).||
0765|117|P|   Low levels of potassium or magnesium in the blood may also||
0765|118|P|increase your risk of QT prolongation. This risk may increase if||
0765|119|P|you use certain drugs (such as diuretics/"water pills") or if you||
0765|120|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0765|121|P|Talk to your doctor about using leuprolide safely.||
0765|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0765|123|P|can make you more dizzy. Do not drive, use machinery, or do||
0765|124|P|anything that needs alertness until you can do it safely. Limit||
0765|125|P|alcoholic beverages. Talk to your doctor if you are using||
0765|126|P|marijuana (cannabis).||
0765|127|P|   Before having surgery, tell your doctor or dentist about all||
0765|128|P|the products you use (including prescription drugs,||
0765|129|P|nonprescription drugs, and herbal products).||
0765|130|P|   Older adults may be more sensitive to the side effects of this||
0765|131|P|drug, especially QT prolongation (see above).||
0765|132|P|   This medication can affect fertility in males. Ask your doctor||
0765|133|P|for more details.||
0765|134|P|   This medication must not be used during pregnancy. It may harm||
0765|135|P|an unborn baby. It is important to prevent pregnancy while using||
0765|136|P|this medication. Consult your doctor for more details and to||
0765|137|P|discuss using reliable forms of non-hormonal birth control (such||
0765|138|P|as condoms, diaphragm with spermicide) while using this||
0765|139|P|medication. If you become pregnant or think you may be pregnant,||
0765|140|P|tell your doctor right away.||
0765|141|P|   It is unknown if leuprolide passes into breast milk. Because||
0765|142|P|of the possible risk to the infant, breastfeeding is not||
0765|143|P|recommended while using this medication. Consult your doctor||
0765|144|P|before breastfeeding.||
0765|145|B|||
0765|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0765|147|I|medications work or increase your risk for serious side effects.||
0765|148|I|This document does not contain all possible drug interactions.||
0765|149|I|Keep a list of all the products you use (including||
0765|150|I|prescription/nonprescription drugs and herbal products) and share||
0765|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
0765|152|I|the dosage of any medicines without your doctor's approval.||
0765|153|I|   This medication may interfere with certain lab tests, possibly||
0765|154|I|causing false test results. Make sure lab personnel and all your||
0765|155|I|doctors know you use this drug.||
0765|156|B|||
0765|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0765|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0765|159|O|poison control center right away. US residents can call||
0765|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0765|161|B|||
0765|162|N|NOTES:  Do not share this medication with others.||
0765|163|N|   Lab and/or medical tests (such as blood testosterone level,||
0765|164|N|PSA blood test, blood glucose, cholesterol/triglyceride levels)||
0765|165|N|should be done while you are using this medication. Keep all||
0765|166|N|medical and lab appointments. Consult your doctor for more||
0765|167|N|details.||
0765|168|B|||
0765|169|D|MISSED DOSE:  It is important to get each dose of this medication||
0765|170|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
0765|171|D|right away for a new dosing schedule. Do not double the dose to||
0765|172|D|catch up.||
0765|173|B|||
0765|174|R|STORAGE:  Not applicable. This medication is given in a clinic or||
0765|175|R|doctor's office and will not be stored at home.||
0765|176|B|||
0765|177|A|Information last revised October 2024.||
0765|178|A|Copyright(c) 2025 First Databank, Inc.||
0765|179|B|||
0766|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0766|002|Z|does NOT have all possible information about this product. This||
0766|003|Z|information does not assure that this product is safe, effective,||
0766|004|Z|or appropriate for you. This information is not individual||
0766|005|Z|medical advice and does not substitute for the advice of your||
0766|006|Z|health care professional. Always ask your health care||
0766|007|Z|professional for complete information about this product and your||
0766|008|Z|specific health needs.||
0766|009|B|||
0766|010|T|LEUPROLIDE 3 MONTH (11.25 MG) - INJECTION||
0766|011|F|(LOO-proe-lide)||
0766|012|B|||
0766|013|C|COMMON BRAND NAME(S): Lupron Depot||
0766|014|B|||
0766|015|U|USES:  Leuprolide is used to treat certain disorders (such as||
0766|016|U|endometriosis, uterine fibroids). For the treatment of uterine||
0766|017|U|fibroids, leuprolide is usually given with iron to help improve||
0766|018|U|anemia that is caused by too much vaginal bleeding. Leuprolide||
0766|019|U|helps to reduce symptoms such as pelvic pain, painful/heavy||
0766|020|U|menstrual periods, and abdominal bloating. It works by shrinking||
0766|021|U|the abnormal tissue that causes these symptoms. The abnormal||
0766|022|U|tissue needs the hormone estrogen to grow and spread. Leuprolide||
0766|023|U|helps to decrease the amount of estrogen that is made in the||
0766|024|U|body.||
0766|025|B|||
0766|026|V|OTHER USES:  This section contains uses of this drug that are not||
0766|027|V|listed in the approved professional labeling for the drug but||
0766|028|V|that may be prescribed by your health care professional. Use this||
0766|029|V|drug for a condition that is listed in this section only if it||
0766|030|V|has been so prescribed by your health care professional.||
0766|031|V|   This drug may also be used for prostate cancer.||
0766|032|B|||
0766|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0766|034|H|from your pharmacist before you start using leuprolide and each||
0766|035|H|time you get a refill. If you have any questions, ask your doctor||
0766|036|H|or pharmacist.||
0766|037|H|   This medication is given by injection into a muscle by a||
0766|038|H|health care professional. It is given as directed by your doctor,||
0766|039|H|usually once every 3 months. This product slowly releases the||
0766|040|H|medication into your blood over a 3-month period.||
0766|041|H|   The length of treatment is based on your medical condition,||
0766|042|H|response to treatment, and lab tests.||
0766|043|H|   Use this medication regularly to get the most benefit from it.||
0766|044|H|To help you remember, mark your calendar with a reminder.||
0766|045|H|   During the first few weeks of treatment, your hormone levels||
0766|046|H|will actually go up before they go down. This is a normal||
0766|047|H|response to this medication. Your symptoms may get worse for a||
0766|048|H|few weeks.||
0766|049|H|   Tell your doctor if your condition does not get better or if||
0766|050|H|it gets worse. It may take at least 3 months for your symptoms to||
0766|051|H|get better.||
0766|052|B|||
0766|053|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
0766|054|S|sweats, tiredness, headache, upset stomach, breast changes, acne,||
0766|055|S|joint/muscle aches, trouble sleeping, reduced sexual interest,||
0766|056|S|vaginal discomfort/dryness, swelling of the ankles/feet,||
0766|057|S|dizziness, or mild burning/pain/bruising at the injection site||
0766|058|S|may occur. If any of these effects last or get worse, tell your||
0766|059|S|doctor or pharmacist promptly.||
0766|060|S|   When this medication is used regularly, your menstrual period||
0766|061|S|should stop (or bleeding should get lighter). Menstrual periods||
0766|062|S|usually return within 3 months after treatment is stopped. Tell||
0766|063|S|your doctor promptly if regular periods continue during treatment||
0766|064|S|with leuprolide.||
0766|065|S|   Remember that this medication has been prescribed because your||
0766|066|S|doctor has judged that the benefit to you is greater than the||
0766|067|S|risk of side effects. Many people using this medication do not||
0766|068|S|have serious side effects.||
0766|069|S|   Tell your doctor right away if you have any serious side||
0766|070|S|effects, including: mental/mood changes (such as depression,||
0766|071|S|thoughts of suicide, mood swings, aggression), new/worsening bone||
0766|072|S|pain, easily broken bones.||
0766|073|S|   Get medical help right away if you have any very serious side||
0766|074|S|effects, including: seizures.||
0766|075|S|   A very serious allergic reaction to this drug is rare.||
0766|076|S|However, get medical help right away if you notice any symptoms||
0766|077|S|of a serious allergic reaction, including: fever, swollen lymph||
0766|078|S|nodes, rash, itching/swelling (especially of the||
0766|079|S|face/tongue/throat), severe dizziness, trouble breathing.||
0766|080|S|   This is not a complete list of possible side effects. If you||
0766|081|S|notice other effects not listed above, contact your doctor or||
0766|082|S|pharmacist.||
0766|083|S|   In the US -||
0766|084|S|   Call your doctor for medical advice about side effects. You||
0766|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0766|086|S|www.fda.gov/medwatch.||
0766|087|S|   In Canada - Call your doctor for medical advice about side||
0766|088|S|effects. You may report side effects to Health Canada at||
0766|089|S|1-866-234-2345.||
0766|090|B|||
0766|091|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
0766|092|P|pharmacist if you are allergic to it; or to similar drugs (such||
0766|093|P|as histrelin, triptorelin); or if you have any other allergies.||
0766|094|P|This product may contain inactive ingredients, which can cause||
0766|095|P|allergic reactions or other problems. Talk to your pharmacist for||
0766|096|P|more details.||
0766|097|P|   Before using this medication, tell your doctor or pharmacist||
0766|098|P|your medical history, especially of: high blood fat levels (such||
0766|099|P|as high cholesterol/triglycerides), mental/mood problems (such as||
0766|100|P|depression), vaginal bleeding of unknown cause, seizures.||
0766|101|P|   Leuprolide may weaken your bones and increase your risk for||
0766|102|P|bone loss (osteoporosis) if used for a long time. Before using||
0766|103|P|this medication, tell your doctor or pharmacist if you have||
0766|104|P|osteoporosis or if you have any of the following risk factors for||
0766|105|P|osteoporosis: long-term alcohol use, smoking, family history of||
0766|106|P|osteoporosis and broken bones, use of certain medications (for||
0766|107|P|example, corticosteroids such as prednisone, certain anti-seizure||
0766|108|P|drugs such as phenytoin).||
0766|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0766|110|P|can make you more dizzy. Do not drive, use machinery, or do||
0766|111|P|anything that needs alertness until you can do it safely. Limit||
0766|112|P|alcoholic beverages. Talk to your doctor if you are using||
0766|113|P|marijuana (cannabis).||
0766|114|P|   This medication must not be used during pregnancy. It may harm||
0766|115|P|an unborn baby. It is important to prevent pregnancy while using||
0766|116|P|this medication. Consult your doctor for more details and to||
0766|117|P|discuss using reliable forms of non-hormonal birth control (such||
0766|118|P|as condoms, diaphragm with spermicide) while using this||
0766|119|P|medication. If you become pregnant or think you may be pregnant,||
0766|120|P|tell your doctor right away.||
0766|121|P|   It is unknown if leuprolide passes into breast milk. Because||
0766|122|P|of the possible risk to the infant, breastfeeding is not||
0766|123|P|recommended while using this medication. Consult your doctor||
0766|124|P|before breastfeeding.||
0766|125|B|||
0766|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0766|127|I|medications work or increase your risk for serious side effects.||
0766|128|I|This document does not contain all possible drug interactions.||
0766|129|I|Keep a list of all the products you use (including||
0766|130|I|prescription/nonprescription drugs and herbal products) and share||
0766|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
0766|132|I|the dosage of any medicines without your doctor's approval.||
0766|133|I|   This medication may interfere with certain lab tests, possibly||
0766|134|I|causing false test results. Make sure lab personnel and all your||
0766|135|I|doctors know you use this drug.||
0766|136|B|||
0766|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0766|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0766|139|O|poison control center right away. US residents can call||
0766|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0766|141|B|||
0766|142|N|NOTES:  Do not share this medication with others.||
0766|143|N|   Lab and/or medical tests (such as hormone levels, bone tests,||
0766|144|N|cholesterol/triglyceride blood levels) should be done while you||
0766|145|N|are using this medication. Keep all medical and lab appointments.||
0766|146|N|Consult your doctor for more details.||
0766|147|B|||
0766|148|D|MISSED DOSE:  It is important to get each dose of this medication||
0766|149|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
0766|150|D|right away for a new dosing schedule. Do not double the dose to||
0766|151|D|catch up.||
0766|152|B|||
0766|153|R|STORAGE:  Not applicable. This medication is given in a clinic or||
0766|154|R|doctor's office and will not be stored at home.||
0766|155|B|||
0766|156|A|Information last revised October 2024.||
0766|157|A|Copyright(c) 2025 First Databank, Inc.||
0766|158|B|||
0767|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0767|002|Z|does NOT have all possible information about this product. This||
0767|003|Z|information does not assure that this product is safe, effective,||
0767|004|Z|or appropriate for you. This information is not individual||
0767|005|Z|medical advice and does not substitute for the advice of your||
0767|006|Z|health care professional. Always ask your health care||
0767|007|Z|professional for complete information about this product and your||
0767|008|Z|specific health needs.||
0767|009|B|||
0767|010|T|IMMUNE GLOBULIN - SUBCUTANEOUS INJECTION||
0767|011|F|(ih-MYOON GLOB-you-lin)||
0767|012|B|||
0767|013|C|COMMON BRAND NAME(S): Cutaquig, Hizentra, Vivaglobin||
0767|014|B|||
0767|015|W|WARNING:  This medication may rarely cause serious problems from||
0767|016|W|blood clots (such as heart attack, stroke, blood clots in the||
0767|017|W|lungs or legs). You may be at increased risk for blood clots if||
0767|018|W|you are an older adult, are severely dehydrated, have a catheter||
0767|019|W|in a vein close to your heart for giving medications, or have a||
0767|020|W|history of blood clots, heart/blood vessel disease, heart||
0767|021|W|failure, stroke, or if you are immobile (such as very long plane||
0767|022|W|flights or bedridden). If you use estrogen-containing products,||
0767|023|W|these may also increase your risk. Before using this medication,||
0767|024|W|discuss the risks and benefits and if you have any of these||
0767|025|W|conditions, report them to your doctor or pharmacist.||
0767|026|W|   The risk of blood clots may be decreased by infusing this||
0767|027|W|medication more slowly or by using a less concentrated form of||
0767|028|W|this medication if available. Being adequately hydrated before||
0767|029|W|receiving this medication may also help reduce this risk.||
0767|030|W|   Get medical help right away if any of these side effects||
0767|031|W|occur: shortness of breath/rapid breathing, chest/jaw/left arm||
0767|032|W|pain, unusual sweating, sudden dizziness/fainting,||
0767|033|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
0767|034|W|trouble speaking, weakness on one side of the body, sudden vision||
0767|035|W|changes, or confusion.||
0767|036|B|||
0767|037|U|USES:  This medication is used to boost the body's natural||
0767|038|U|defense system against infection in persons with a weakened||
0767|039|U|immune system (primary immune deficiency). Immune globulin||
0767|040|U|contains natural substances called antibodies (a type called IgG)||
0767|041|U|that come from healthy human blood (plasma). These antibodies||
0767|042|U|help protect your body against infections and help you to fight||
0767|043|U|an infection if you get sick.||
0767|044|U|   Some immune globulin products may also be used to treat a||
0767|045|U|certain nerve disorder (chronic inflammatory demyelinating||
0767|046|U|polyneuropathy-CIDP).||
0767|047|B|||
0767|048|H|HOW TO USE:  Read the Patient Information Leaflet and||
0767|049|H|Instructions for Use if available from your pharmacist before you||
0767|050|H|start using immune globulin and each time you get a refill. If||
0767|051|H|you have any questions, consult your doctor or pharmacist.||
0767|052|H|   This medication is given slowly by injection (infusion) under||
0767|053|H|the skin as directed by your doctor. The injection is given in||
0767|054|H|the abdomen, thighs, upper arms, or hips. Depending on your||
0767|055|H|product, this medication may be given as often as every day up to||
0767|056|H|once every 2 weeks. Follow your doctor's instructions carefully||
0767|057|H|on how often to receive this medication. The dosage is based on||
0767|058|H|your medical condition, weight, and response to treatment.||
0767|059|H|   If you are using this medication at home, learn all||
0767|060|H|preparation and usage instructions from your health care||
0767|061|H|professional and the product package.||
0767|062|H|   Do not shake this medication. Before using, check this product||
0767|063|H|for particles or discoloration. If either is present, do not use||
0767|064|H|the liquid. Before injecting each dose, clean the skin you are||
0767|065|H|going to inject into (the injection site) with rubbing alcohol.||
0767|066|H|Change the injection site(s) each time to lessen injury under the||
0767|067|H|skin. To lessen bruising, do not rub the injection site after||
0767|068|H|each dose. Learn how to store and discard medical supplies||
0767|069|H|safely.||
0767|070|H|   Patients who are getting immune globulin for the first time,||
0767|071|H|those who are switched from another brand of immune globulin, or||
0767|072|H|those who have not received immune globulin in the past 2 months||
0767|073|H|may be at risk of developing fever, chills, nausea, vomiting, and||
0767|074|H|rarely shock. It is recommended that these patients receive their||
0767|075|H|first dose of this medication in the doctor's office/clinic so||
0767|076|H|they can be monitored for these side effects.||
0767|077|H|   Use this medication regularly to get the most benefit from it.||
0767|078|H|To help you remember, mark your calendar with a reminder.||
0767|079|B|||
0767|080|S|SIDE EFFECTS:  See also Warning section.||
0767|081|S|   Mild swelling, redness, or itching at the injection site may||
0767|082|S|occur and usually lessen as your body adjusts to the medication.||
0767|083|S|Headache, upset stomach, fever, nausea, diarrhea, sore throat,||
0767|084|S|cough, or pain may also occur. If any of these effects last or||
0767|085|S|get worse, tell your doctor or pharmacist promptly.||
0767|086|S|   Remember that this medication has been prescribed because your||
0767|087|S|doctor has judged that the benefit to you is greater than the||
0767|088|S|risk of side effects. Many people using this medication do not||
0767|089|S|have serious side effects.||
0767|090|S|   Tell your doctor right away if you have any serious side||
0767|091|S|effects, including: signs of kidney problems (such as change in||
0767|092|S|the amount of urine), sudden weight gain, fast heartbeat.||
0767|093|S|   Get medical help right away if you have any very serious side||
0767|094|S|effects, including: severe headache, stiff neck, eye pain,||
0767|095|S|sensitivity to light, trouble breathing.||
0767|096|S|   A very serious allergic reaction to this drug is rare.||
0767|097|S|However, get medical help right away if you notice any symptoms||
0767|098|S|of a serious allergic reaction, including: rash, itching/swelling||
0767|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0767|100|S|breathing.||
0767|101|S|   This is not a complete list of possible side effects. If you||
0767|102|S|notice other effects not listed above, contact your doctor or||
0767|103|S|pharmacist.||
0767|104|S|   In the US -||
0767|105|S|   Call your doctor for medical advice about side effects. You||
0767|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0767|107|S|www.fda.gov/medwatch.||
0767|108|S|   In Canada - Call your doctor for medical advice about side||
0767|109|S|effects. You may report side effects to Health Canada at||
0767|110|S|1-866-234-2345.||
0767|111|B|||
0767|112|P|PRECAUTIONS:  See also Warning section.||
0767|113|P|   Before using this medication, tell your doctor or pharmacist||
0767|114|P|if you are allergic to it; or to other immune globulin products;||
0767|115|P|or if you have any other allergies. This product may contain||
0767|116|P|inactive ingredients (such as polysorbate 80), which can cause||
0767|117|P|allergic reactions or other problems. Talk to your pharmacist for||
0767|118|P|more details.||
0767|119|P|   Before using this medication, tell your doctor or pharmacist||
0767|120|P|your medical history, especially of: certain immune system||
0767|121|P|problems (selective immunoglobulin A deficiency with known||
0767|122|P|antibody against IgA, monoclonal gammopathy), kidney disease,||
0767|123|P|diabetes, current blood infection, severe loss of body fluids||
0767|124|P|(dehydration).||
0767|125|P|   Some immune globulin products are made with maltose. This||
0767|126|P|substance can cause false high blood sugar levels when your blood||
0767|127|P|sugar is normal or even low. If you have diabetes, check with||
0767|128|P|your pharmacist whether the product you are using contains||
0767|129|P|maltose and whether your blood sugar testing supplies will work||
0767|130|P|with this product. Rarely, serious problems have occurred when||
0767|131|P|too much insulin was given because of false high sugar readings||
0767|132|P|or when low blood sugar went untreated.||
0767|133|P|   Tell your doctor of any recent or planned||
0767|134|P|immunizations/vaccinations. This medication may prevent a good||
0767|135|P|response to certain live viral vaccines (such as measles, mumps,||
0767|136|P|rubella, varicella). If you have recently received any of these||
0767|137|P|vaccines, your doctor may have you tested for a response or have||
0767|138|P|you vaccinated again later. If you plan on getting any of these||
0767|139|P|vaccines, your doctor will instruct you about the best time to||
0767|140|P|receive them so you get a good response.||
0767|141|P|   This medication is made from human blood. Even though the||
0767|142|P|blood is carefully tested, and this medication goes through a||
0767|143|P|special manufacturing process, there is an extremely small chance||
0767|144|P|that you may get infections from the medication (for example,||
0767|145|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
0767|146|P|more information.||
0767|147|P|   Before having surgery, tell your doctor or dentist about all||
0767|148|P|the products you use (including prescription drugs,||
0767|149|P|nonprescription drugs, and herbal products).||
0767|150|P|   During pregnancy, this medication should be used only when||
0767|151|P|clearly needed. Discuss the risks and benefits with your doctor.||
0767|152|P|   It is unknown if this drug passes into breast milk. Consult||
0767|153|P|your doctor before breastfeeding.||
0767|154|B|||
0767|155|I|DRUG INTERACTIONS:  See also Warning section.||
0767|156|I|   Drug interactions may change how your medications work or||
0767|157|I|increase your risk for serious side effects. This document does||
0767|158|I|not contain all possible drug interactions. Keep a list of all||
0767|159|I|the products you use (including prescription/nonprescription||
0767|160|I|drugs and herbal products) and share it with your doctor and||
0767|161|I|pharmacist. Do not start, stop, or change the dosage of any||
0767|162|I|medicines without your doctor's approval.||
0767|163|I|   This medication may interfere with certain tests (including||
0767|164|I|certain blood sugar tests, blood type, Coombs test), possibly||
0767|165|I|causing false test results. This can lead to serious (possibly||
0767|166|I|fatal) consequences. Tell all lab personnel and all your doctors||
0767|167|I|and pharmacists that you use this medication, and which type of||
0767|168|I|blood sugar testing strips you use.||
0767|169|B|||
0767|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0767|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0767|172|O|poison control center right away. US residents can call||
0767|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0767|174|B|||
0767|175|N|NOTES:  Do not share this medication with others.||
0767|176|N|   Lab and/or medical tests (such as IgG levels, complete blood||
0767|177|N|count) should be done while you are using this medication. Keep||
0767|178|N|all medical and lab appointments. Consult your doctor for more||
0767|179|N|details.||
0767|180|B|||
0767|181|D|MISSED DOSE:  It is important to get each dose of this medication||
0767|182|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0767|183|D|right away for a new dosing schedule. Do not double the dose to||
0767|184|D|catch up.||
0767|185|B|||
0767|186|R|STORAGE:  Different brands of this medication have different||
0767|187|R|storage needs. Check the product package for instructions on how||
0767|188|R|to store your brand, or ask your pharmacist. Keep all medications||
0767|189|R|away from children and pets.||
0767|190|R|   Do not flush medications down the toilet or pour them into a||
0767|191|R|drain unless instructed to do so. Properly discard this product||
0767|192|R|when it is expired or no longer needed. Consult your pharmacist||
0767|193|R|or local waste disposal company.||
0767|194|B|||
0767|195|A|Information last revised June 2025.||
0767|196|A|Copyright(c) 2025 First Databank, Inc.||
0767|197|B|||
0768|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0768|002|Z|does NOT have all possible information about this product. This||
0768|003|Z|information does not assure that this product is safe, effective,||
0768|004|Z|or appropriate for you. This information is not individual||
0768|005|Z|medical advice and does not substitute for the advice of your||
0768|006|Z|health care professional. Always ask your health care||
0768|007|Z|professional for complete information about this product and your||
0768|008|Z|specific health needs.||
0768|009|B|||
0768|010|T|EFAVIRENZ/EMTRICITABINE/TENOFOVIR - ORAL||
0768|011|F|(eh-FAV-er-enz/em-tri-SITE-ah-bean/te-NOE-fo-veer)||
0768|012|B|||
0768|013|C|COMMON BRAND NAME(S): Atripla||
0768|014|B|||
0768|015|W|WARNING:  If you have hepatitis B infection, your hepatitis||
0768|016|W|symptoms may get worse or become very serious if you stop taking||
0768|017|W|this medication. Talk with your doctor before stopping this||
0768|018|W|medication. Your doctor will monitor liver tests for several||
0768|019|W|months after you stop efavirenz/emtricitabine/tenofovir. Tell||
0768|020|W|your doctor right away if you develop symptoms of worsening liver||
0768|021|W|problems.||
0768|022|B|||
0768|023|U|USES:  This product contains 3 different medications: efavirenz,||
0768|024|U|emtricitabine, and tenofovir. It is used alone or with other HIV||
0768|025|U|medications to help control HIV infection. It helps to decrease||
0768|026|U|the amount of HIV in your body so your immune system can work||
0768|027|U|better. This lowers your chance of getting HIV complications||
0768|028|U|(such as new infections, cancer) and improves your quality of||
0768|029|U|life. Efavirenz belongs to a class of drugs known as||
0768|030|U|non-nucleoside reverse transcriptase inhibitors (NNRTIs).||
0768|031|U|Emtricitabine and tenofovir belong to a class of drugs known as||
0768|032|U|nucleoside reverse transcriptase inhibitors (NRTIs).||
0768|033|U|   Efavirenz/emtricitabine/tenofovir is not a cure for HIV||
0768|034|U|infection. To decrease your risk of spreading HIV disease to||
0768|035|U|others, continue to take all HIV medications exactly as||
0768|036|U|prescribed by your doctor. Use an effective barrier method (latex||
0768|037|U|or polyurethane condoms/dental dams) during sexual activity as||
0768|038|U|directed by your doctor. Do not share personal items (such as||
0768|039|U|needles/syringes, toothbrushes, and razors) that may have||
0768|040|U|contacted blood or other body fluids. Consult your doctor or||
0768|041|U|pharmacist for more details.||
0768|042|B|||
0768|043|V|OTHER USES:  This section contains uses of this drug that are not||
0768|044|V|listed in the approved professional labeling for the drug but||
0768|045|V|that may be prescribed by your health care professional. Use this||
0768|046|V|drug for a condition that is listed in this section only if it||
0768|047|V|has been so prescribed by your health care professional.||
0768|048|V|   This product may also be used to lessen the risk of HIV||
0768|049|V|infection after contact with the virus (for example, due to a||
0768|050|V|needle stick). Ask your doctor for more details.||
0768|051|B|||
0768|052|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0768|053|H|from your pharmacist before you start taking||
0768|054|H|efavirenz/emtricitabine/tenofovir and each time you get a refill.||
0768|055|H|If you have any questions, ask your doctor or pharmacist.||
0768|056|H|   Take this medication by mouth on an empty stomach as directed||
0768|057|H|by your doctor, usually once daily at bedtime. Taking this||
0768|058|H|medication at bedtime helps to decrease some of the side effects.||
0768|059|H|See Side Effects section.||
0768|060|H|   Because this combination product has fixed doses of efavirenz,||
0768|061|H|emtricitabine, and tenofovir, you should only use it if your||
0768|062|H|doctor has determined that the doses of all 3 medications in this||
0768|063|H|product are right for you.||
0768|064|H|   It is very important to keep taking this medication (and other||
0768|065|H|HIV medications) exactly as prescribed by your doctor. Do not||
0768|066|H|skip any doses. Do not increase your dose, take this drug more||
0768|067|H|often than prescribed, or stop taking it (or other HIV medicines)||
0768|068|H|even for a short time unless directed to do so by your doctor.||
0768|069|H|Skipping or changing your dose without approval from your doctor||
0768|070|H|may cause the amount of virus to increase, make the infection||
0768|071|H|more difficult to treat (resistant), or worsen side effects.||
0768|072|H|   For the best effect, take this medication at evenly spaced||
0768|073|H|times. To help you remember, take this medication at the same||
0768|074|H|time every day.||
0768|075|B|||
0768|076|S|SIDE EFFECTS:  Dizziness, trouble sleeping, drowsiness, unusual||
0768|077|S|dreams, and trouble concentrating may often occur. These side||
0768|078|S|effects may begin 1-2 days after starting this medication and||
0768|079|S|usually go away in 2-4 weeks. They are also reduced by taking||
0768|080|S|this medication on an empty stomach at bedtime.||
0768|081|S|   Tiredness, headache, diarrhea, and skin discoloration (such as||
0768|082|S|small spots/freckles, darkening of the palms of the hands/soles||
0768|083|S|of the feet) may also occur.||
0768|084|S|   If any of these effects last or get worse, tell your doctor or||
0768|085|S|pharmacist promptly.||
0768|086|S|   Remember that this medication has been prescribed because your||
0768|087|S|doctor has judged that the benefit to you is greater than the||
0768|088|S|risk of side effects. Many people using this medication do not||
0768|089|S|have serious side effects.||
0768|090|S|   As your immune system gets stronger, it can begin to fight off||
0768|091|S|infections you already had, possibly causing disease symptoms to||
0768|092|S|come back. You could also have symptoms if your immune system||
0768|093|S|becomes overactive. This reaction may happen at any time (soon||
0768|094|S|after starting HIV treatment or many months later). Tell your||
0768|095|S|doctor right away if you have any serious symptoms, including:||
0768|096|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
0768|097|S|that doesn't go away, headaches that are severe or don't go away,||
0768|098|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
0768|099|S|changes, signs of infection (such as sore throat that doesn't go||
0768|100|S|away, fever, chills, swollen lymph nodes, non-healing skin||
0768|101|S|sores), signs of an overactive thyroid (such as irritability,||
0768|102|S|nervousness, heat intolerance, fast/pounding/irregular||
0768|103|S|heartbeat).||
0768|104|S|   Tell your doctor right away if you have any serious side||
0768|105|S|effects, including: mental/mood changes (such as depression, rare||
0768|106|S|thoughts of suicide, strange thoughts, anxiety, angry behavior,||
0768|107|S|hallucinations, confusion), loss of coordination, signs of kidney||
0768|108|S|problems (such as a change in the amount of urine), unusual||
0768|109|S|thirst, signs of pancreatitis (such as nausea, vomiting,||
0768|110|S|stomach/abdominal/back pain, fever).||
0768|111|S|   Rarely, this medication can cause severe (sometimes fatal)||
0768|112|S|liver and blood problems (lactic acidosis). Tell your doctor||
0768|113|S|right away if you develop symptoms of liver problems (such as||
0768|114|S|nausea/vomiting that doesn't stop, loss of appetite,||
0768|115|S|stomach/abdominal pain, yellowing eyes/skin, dark urine) or||
0768|116|S|lactic acidosis (such as deep/rapid breathing, drowsiness,||
0768|117|S|nausea/vomiting, unusual weakness).||
0768|118|S|   Changes in body fat may occur while you are taking this||
0768|119|S|medication (such as increased fat in the upper back and stomach||
0768|120|S|areas, decreased fat in the arms and legs). The cause and||
0768|121|S|long-term effects of these changes are unknown. Discuss the risks||
0768|122|S|and benefits of treatment with your doctor, as well as the||
0768|123|S|possible use of exercise to reduce this side effect.||
0768|124|S|   Tenofovir may increase the risk of bone loss. Discuss the||
0768|125|S|risks and benefits of treatment with your doctor, as well as the||
0768|126|S|possible use of calcium and vitamin D to reduce this side effect.||
0768|127|S|If you are at risk for bone loss, your doctor may monitor your||
0768|128|S|bone mineral density. Tell your doctor right away if any of the||
0768|129|S|following serious side effects occur: bone pain, easily broken||
0768|130|S|bones.||
0768|131|S|   Get medical help right away if you have any very serious side||
0768|132|S|effects, including: fast/irregular heartbeat, severe dizziness,||
0768|133|S|fainting.||
0768|134|S|   Efavirenz/emtricitabine/tenofovir can commonly cause a rash||
0768|135|S|that is usually not serious. However, you may not be able to tell||
0768|136|S|it apart from a rare rash that could be a sign of a severe||
0768|137|S|reaction. Get medical help right away if you develop any rash.||
0768|138|S|   A very serious allergic reaction to this drug is rare.||
0768|139|S|However, get medical help right away if you notice any symptoms||
0768|140|S|of a serious allergic reaction, including: rash, blisters,||
0768|141|S|peeling skin, fever, itching/swelling (especially of the||
0768|142|S|face/tongue/throat), severe dizziness, trouble breathing.||
0768|143|S|   This is not a complete list of possible side effects. If you||
0768|144|S|notice other effects not listed above, contact your doctor or||
0768|145|S|pharmacist.||
0768|146|S|   In the US -||
0768|147|S|   Call your doctor for medical advice about side effects. You||
0768|148|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0768|149|S|www.fda.gov/medwatch.||
0768|150|S|   In Canada - Call your doctor for medical advice about side||
0768|151|S|effects. You may report side effects to Health Canada at||
0768|152|S|1-866-234-2345.||
0768|153|B|||
0768|154|P|PRECAUTIONS:  Before taking efavirenz/emtricitabine/tenofovir,||
0768|155|P|tell your doctor or pharmacist if you are allergic to any of the||
0768|156|P|ingredients; or if you have any other allergies. This product may||
0768|157|P|contain inactive ingredients, which can cause allergic reactions||
0768|158|P|or other problems. Talk to your pharmacist for more details.||
0768|159|P|   Before using this medication, tell your doctor or pharmacist||
0768|160|P|your medical history, especially of: kidney problems, liver||
0768|161|P|problems (such as hepatitis B or C, cirrhosis), mental/mood||
0768|162|P|conditions (such as depression, thoughts of suicide, psychosis),||
0768|163|P|drug/substance/alcohol abuse, seizures, high||
0768|164|P|cholesterol/triglyceride levels, bone problems (such as bone||
0768|165|P|disease, bone loss/osteoporosis, weak/broken bones), disease of||
0768|166|P|the pancreas (pancreatitis).||
0768|167|P|   Efavirenz/emtricitabine/tenofovir may cause a condition that||
0768|168|P|affects the heart rhythm (QT prolongation). QT prolongation can||
0768|169|P|rarely cause serious (rarely fatal) fast/irregular heartbeat and||
0768|170|P|other symptoms (such as severe dizziness, fainting) that need||
0768|171|P|medical attention right away.||
0768|172|P|   The risk of QT prolongation may be increased if you have||
0768|173|P|certain medical conditions or are taking other drugs that may||
0768|174|P|cause QT prolongation. Before using||
0768|175|P|efavirenz/emtricitabine/tenofovir, tell your doctor or pharmacist||
0768|176|P|of all the drugs you take and if you have any of the following||
0768|177|P|conditions: certain heart problems (heart failure, slow||
0768|178|P|heartbeat, QT prolongation in the EKG), family history of certain||
0768|179|P|heart problems (QT prolongation in the EKG, sudden cardiac||
0768|180|P|death).||
0768|181|P|   Low levels of potassium or magnesium in the blood may also||
0768|182|P|increase your risk of QT prolongation. This risk may increase if||
0768|183|P|you use certain drugs (such as diuretics "water pills") or if you||
0768|184|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0768|185|P|Talk to your doctor about using efavirenz/emtricitabine/tenofovir||
0768|186|P|safely.||
0768|187|P|   This drug may make you dizzy or drowsy or cause trouble||
0768|188|P|concentrating. Alcohol or marijuana (cannabis) can worsen these||
0768|189|P|effects. Do not drive, use machinery, or do anything that needs||
0768|190|P|alertness until you can do it safely. Avoid alcoholic beverages||
0768|191|P|because they may also worsen the side effects of this medication||
0768|192|P|(such as liver problems, pancreatitis, mental/mood symptoms).||
0768|193|P|Talk to your doctor if you are using marijuana (cannabis).||
0768|194|P|   Before having surgery, tell your doctor or dentist about all||
0768|195|P|the products you use (including prescription drugs,||
0768|196|P|nonprescription drugs, and herbal products).||
0768|197|P|   A rash may be more common and serious in children taking this||
0768|198|P|medication. Report any rash right away. The doctor may prescribe||
0768|199|P|an antihistamine for your child to take before this medication is||
0768|200|P|started. Consult the doctor for more information.||
0768|201|P|   Older adults may be more sensitive to the side effects of this||
0768|202|P|drug, especially QT prolongation (see above).||
0768|203|P|   During pregnancy, this medication should be used only when||
0768|204|P|clearly needed. Treatment can lower the risk of passing HIV||
0768|205|P|infection to your baby, and efavirenz/emtricitabine/tenofovir may||
0768|206|P|be part of that treatment. Discuss the risks and benefits with||
0768|207|P|your doctor.||
0768|208|P|   This medication passes into breast milk. Because breast milk||
0768|209|P|may transmit HIV, consult your doctor before breastfeeding.||
0768|210|B|||
0768|211|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0768|212|I|medications work or increase your risk for serious side effects.||
0768|213|I|This document does not contain all possible drug interactions.||
0768|214|I|Keep a list of all the products you use (including||
0768|215|I|prescription/nonprescription drugs and herbal products) and share||
0768|216|I|it with your doctor and pharmacist. Do not start, stop, or change||
0768|217|I|the dosage of any medicines without your doctor's approval.||
0768|218|I|   Some products that may interact with this drug include:||
0768|219|I|orlistat, other drugs that may affect the kidneys (including||
0768|220|I|adefovir, cidofovir, aminoglycosides such as amikacin/||
0768|221|I|gentamicin).||
0768|222|I|   Do not take this medication with other products that contain||
0768|223|I|emtricitabine or tenofovir. Do not take this medication with||
0768|224|I|another efavirenz product unless specifically directed by your||
0768|225|I|doctor. Also, lamivudine is similar to emtricitabine and should||
0768|226|I|not be taken with this medication.||
0768|227|I|   Other medications can affect the removal of||
0768|228|I|efavirenz/emtricitabine/tenofovir from your body, which may||
0768|229|I|affect how this product works. Examples include some drugs used||
0768|230|I|to treat seizures (such as carbamazepine), among others.||
0768|231|I|   Efavirenz/emtricitabine/tenofovir can speed up the removal of||
0768|232|I|many other medications from your body, which may affect how they||
0768|233|I|work. Examples of affected drugs include atazanavir,||
0768|234|I|atovaquone/proguanil, azole antifungals (such as voriconazole),||
0768|235|I|bedaquiline, cabotegravir, cobicistat, elbasvir/grazoprevir,||
0768|236|I|elvitegravir, macrolide antibiotics (such as clarithromycin),||
0768|237|I|rilpivirine, sofosbuvir/velpatasvir, among others.||
0768|238|I|   This medication may decrease the effectiveness of hormonal||
0768|239|I|birth control such as pills, patch, or ring. This could cause||
0768|240|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0768|241|I|use reliable backup birth control methods while using this||
0768|242|I|medication. Also tell your doctor if you have any new spotting or||
0768|243|I|breakthrough bleeding, because these may be signs that your birth||
0768|244|I|control is not working well.||
0768|245|I|   Tell your doctor or pharmacist if you are taking other||
0768|246|I|products that cause drowsiness including alcohol, marijuana||
0768|247|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0768|248|I|drugs for sleep or anxiety (such as diazepam, zolpidem), muscle||
0768|249|I|relaxants, and opioid pain relievers (such as codeine).||
0768|250|I|   Check the labels on all your medicines (such as allergy or||
0768|251|I|cough-and-cold products) because they may contain ingredients||
0768|252|I|that cause drowsiness. Ask your pharmacist about using those||
0768|253|I|products safely.||
0768|254|I|   This medication may interfere with certain lab tests (such as||
0768|255|I|urine cannabinoid tests), possibly causing false test results.||
0768|256|I|Make sure lab personnel and all your doctors know you use this||
0768|257|I|drug.||
0768|258|B|||
0768|259|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0768|260|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0768|261|O|poison control center right away. US residents can call||
0768|262|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0768|263|B|||
0768|264|N|NOTES:  Do not share this medication with others.||
0768|265|N|   Lab and/or medical tests (such as kidney/liver function, test||
0768|266|N|for hepatitis B virus, viral load, T-cell counts, cholesterol and||
0768|267|N|triglyceride levels, blood mineral levels, bone density tests,||
0768|268|N|urine glucose/protein) should be done before you start taking||
0768|269|N|this medication and while you are taking it. Keep all medical and||
0768|270|N|lab appointments.||
0768|271|B|||
0768|272|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0768|273|D|remember. If it is near the time of the next dose, skip the||
0768|274|D|missed dose. Take your next dose at the regular time. Do not||
0768|275|D|double the dose to catch up.||
0768|276|B|||
0768|277|R|STORAGE:  Store in the original container at room temperature||
0768|278|R|away from light and moisture. Do not store in the bathroom. Keep||
0768|279|R|all medications away from children and pets.||
0768|280|R|   Do not flush medications down the toilet or pour them into a||
0768|281|R|drain unless instructed to do so. Properly discard this product||
0768|282|R|when it is expired or no longer needed. Consult your pharmacist||
0768|283|R|or local waste disposal company.||
0768|284|B|||
0768|285|A|Information last revised April 2025.||
0768|286|A|Copyright(c) 2025 First Databank, Inc.||
0768|287|B|||
0769|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0769|002|Z|does NOT have all possible information about this product. This||
0769|003|Z|information does not assure that this product is safe, effective,||
0769|004|Z|or appropriate for you. This information is not individual||
0769|005|Z|medical advice and does not substitute for the advice of your||
0769|006|Z|health care professional. Always ask your health care||
0769|007|Z|professional for complete information about this product and your||
0769|008|Z|specific health needs.||
0769|009|B|||
0769|010|T|ALUMINUM/MAGNESIUM ANTACID/SIMETHICONE - ORAL||
0769|011|F|(a-LOO-mi-num/mag-NEE-zee-um/sye-METH-i-kone)||
0769|012|B|||
0769|013|U|USES:  This medication is used to treat the symptoms of too much||
0769|014|U|stomach acid such as stomach upset, heartburn, and acid||
0769|015|U|indigestion. It is also used to relieve symptoms of extra gas||
0769|016|U|such as belching, bloating, and feelings of pressure/discomfort||
0769|017|U|in the stomach/gut. Simethicone helps break up gas bubbles in the||
0769|018|U|gut. Aluminum and magnesium antacids work quickly to lower the||
0769|019|U|acid in the stomach. Liquid antacids usually work faster/better||
0769|020|U|than tablets or capsules.||
0769|021|U|   This medication works only on existing acid in the stomach. It||
0769|022|U|does not prevent acid production. It may be used alone or with||
0769|023|U|other medications that lower acid production (including H2||
0769|024|U|blockers such as cimetidine/ranitidine and proton pump inhibitors||
0769|025|U|such as omeprazole).||
0769|026|U|   If you are self-treating with this medication, carefully read||
0769|027|U|the package instructions before you start using this product to||
0769|028|U|be sure it is right for you. Some products have similar brand||
0769|029|U|names but different active ingredients with different uses.||
0769|030|U|Taking the wrong product could harm you. Ask your pharmacist if||
0769|031|U|you have any questions about your product or its use.||
0769|032|B|||
0769|033|H|HOW TO USE:  Take this medication by mouth, usually after meals||
0769|034|H|and at bedtime as needed. Follow all the directions on the||
0769|035|H|product package or use as directed by your doctor. If you have||
0769|036|H|any questions, ask your doctor or pharmacist.||
0769|037|H|   If you are taking the chewable tablets, chew thoroughly before||
0769|038|H|swallowing, then drink a full glass of water (8 ounces or 240||
0769|039|H|milliliters).||
0769|040|H|   If you are using the liquid form of this medication, shake the||
0769|041|H|bottle well before pouring each dose. Measure the dose out||
0769|042|H|carefully using a medication spoon/cup. Do not use a household||
0769|043|H|spoon because you may not get the right dose. Refrigerating the||
0769|044|H|suspension may improve the flavor. Do not freeze. The liquid form||
0769|045|H|works best if taken without other fluids. You can mix your dose||
0769|046|H|with a little water if needed.||
0769|047|H|   If your acid problems last or get worse after you have used||
0769|048|H|this product for 1 week, or if you think you have a serious||
0769|049|H|medical problem, get medical help right away. If you are using||
0769|050|H|this medication regularly on a daily basis for more than 2 weeks,||
0769|051|H|you may have a medical problem that needs different treatment.||
0769|052|H|Ask your doctor whether this is the right medication for you.||
0769|053|B|||
0769|054|S|SIDE EFFECTS:  Nausea, constipation, diarrhea, or headache may||
0769|055|S|occur. If any of these effects last or get worse, tell your||
0769|056|S|doctor or pharmacist promptly.||
0769|057|S|   The magnesium in this product can cause diarrhea. Using an||
0769|058|S|antacid that contains only aluminum along with this product can||
0769|059|S|help control diarrhea. The aluminum in this product can cause||
0769|060|S|constipation. To minimize constipation, drink plenty of fluids||
0769|061|S|and exercise. Diarrhea is more common with this product than||
0769|062|S|constipation.||
0769|063|S|   If your doctor has directed you to use this medication,||
0769|064|S|remember that your doctor has judged that the benefit to you is||
0769|065|S|greater than the risk of side effects. Many people using this||
0769|066|S|medication do not have serious side effects.||
0769|067|S|   Aluminum-containing antacids bind to phosphate, an important||
0769|068|S|body chemical, in the gut. This can cause low phosphate levels,||
0769|069|S|especially if you use this medication in large doses and for a||
0769|070|S|long time. Tell your doctor right away if you have any of the||
0769|071|S|following symptoms of low phosphate: loss of appetite, unusual||
0769|072|S|tiredness, muscle weakness.||
0769|073|S|   Tell your doctor right away if you have any serious side||
0769|074|S|effects, including: dizziness, fainting.||
0769|075|S|   Get medical help right away if you have any very serious side||
0769|076|S|effects, including: slow/shallow breathing, slow/irregular||
0769|077|S|heartbeat, mental/mood changes (such as confusion), deep sleep,||
0769|078|S|pain with urination.||
0769|079|S|   A very serious allergic reaction to this drug is rare.||
0769|080|S|However, get medical help right away if you notice any symptoms||
0769|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0769|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0769|083|S|breathing.||
0769|084|S|   This is not a complete list of possible side effects. If you||
0769|085|S|notice other effects not listed above, contact your doctor or||
0769|086|S|pharmacist.||
0769|087|S|   In the US -||
0769|088|S|   Call your doctor for medical advice about side effects. You||
0769|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0769|090|S|www.fda.gov/medwatch.||
0769|091|S|   In Canada - Call your doctor for medical advice about side||
0769|092|S|effects. You may report side effects to Health Canada at||
0769|093|S|1-866-234-2345.||
0769|094|B|||
0769|095|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0769|096|P|pharmacist if you are allergic to aluminum hydroxide; or to||
0769|097|P|magnesium; or to simethicone; or if you have any other allergies.||
0769|098|P|This product may contain inactive ingredients, which can cause||
0769|099|P|allergic reactions or other problems. Talk to your pharmacist for||
0769|100|P|more details.||
0769|101|P|   If you have any of the following health problems, consult your||
0769|102|P|doctor or pharmacist before using this product: frequent alcohol||
0769|103|P|use, dehydration/fluid restriction, kidney problems (including||
0769|104|P|kidney stones).||
0769|105|P|   This medicine may contain aspartame. If you have||
0769|106|P|phenylketonuria (PKU) or any other condition that requires you to||
0769|107|P|restrict your intake of aspartame (or phenylalanine), consult||
0769|108|P|your doctor or pharmacist about using this drug safely.||
0769|109|P|   This medicine may contain sugar. If you have diabetes, consult||
0769|110|P|your doctor or pharmacist about using this drug safely.||
0769|111|P|   Before having surgery, tell your doctor or dentist about all||
0769|112|P|the products you use (including prescription drugs,||
0769|113|P|nonprescription drugs, and herbal products).||
0769|114|P|   During pregnancy, this medication should be used only when||
0769|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
0769|116|P|   This medication may pass into breast milk. Consult your doctor||
0769|117|P|before breastfeeding.||
0769|118|B|||
0769|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0769|120|I|medications work or increase your risk for serious side effects.||
0769|121|I|This document does not contain all possible drug interactions.||
0769|122|I|Keep a list of all the products you use (including||
0769|123|I|prescription/nonprescription drugs and herbal products) and share||
0769|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
0769|125|I|the dosage of any medicines without your doctor's approval.||
0769|126|I|   Antacids can interfere with the absorption of many other||
0769|127|I|drugs. Be sure to check with your pharmacist before taking||
0769|128|I|antacids with any other medication.||
0769|129|B|||
0769|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0769|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0769|132|O|poison control center right away. US residents can call||
0769|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0769|134|B|||
0769|135|N|NOTES:  Keep all medical and lab appointments.||
0769|136|N|   Lifestyle changes such as stress reduction programs, stopping||
0769|137|N|smoking, limiting alcohol, and diet changes (such as avoiding||
0769|138|N|caffeine, fatty foods, certain spices) may increase the||
0769|139|N|effectiveness of this medication. Talk to your doctor or||
0769|140|N|pharmacist about lifestyle changes that might benefit you.||
0769|141|B|||
0769|142|D|MISSED DOSE:  If you are taking this product on a regular||
0769|143|D|schedule and miss a dose, take it as soon as you remember. If it||
0769|144|D|is near the time of the next dose, skip the missed dose. Take||
0769|145|D|your next dose at the regular time. Do not double the dose to||
0769|146|D|catch up.||
0769|147|B|||
0769|148|R|STORAGE:  Store at room temperature away from light and moisture.||
0769|149|R|The liquid product may be stored in the refrigerator to improve||
0769|150|R|taste. Do not freeze. Do not store in the bathroom. Keep all||
0769|151|R|medications away from children and pets.||
0769|152|R|   Do not flush medications down the toilet or pour them into a||
0769|153|R|drain unless instructed to do so. Properly discard this product||
0769|154|R|when it is expired or no longer needed. Consult your pharmacist||
0769|155|R|or local waste disposal company.||
0769|156|B|||
0769|157|A|Information last revised October 2025.||
0769|158|A|Copyright(c) 2025 First Databank, Inc.||
0769|159|B|||
0770|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0770|002|Z|does NOT have all possible information about this product. This||
0770|003|Z|information does not assure that this product is safe, effective,||
0770|004|Z|or appropriate for you. This information is not individual||
0770|005|Z|medical advice and does not substitute for the advice of your||
0770|006|Z|health care professional. Always ask your health care||
0770|007|Z|professional for complete information about this product and your||
0770|008|Z|specific health needs.||
0770|009|B|||
0770|010|T|HISTRELIN - IMPLANT||
0770|011|F|(HISS-treh-lin)||
0770|012|B|||
0770|013|C|COMMON BRAND NAME(S): Supprelin LA, Vantas||
0770|014|B|||
0770|015|U|USES:  Histrelin is used to treat advanced prostate cancer. It is||
0770|016|U|not a cure. Most types of prostate cancer need the hormone||
0770|017|U|testosterone to grow and spread. Histrelin works by reducing the||
0770|018|U|amount of testosterone that the body makes. This helps slow or||
0770|019|U|stop the growth of cancer cells and helps relieve symptoms such||
0770|020|U|as painful/difficult urination. Talk to your doctor about the||
0770|021|U|risks and benefits of treatment.||
0770|022|U|   Histrelin is also used by children to treat early puberty||
0770|023|U|(central precocious puberty). It helps to slow abnormally fast||
0770|024|U|bone development so that height and growth rate are near normal||
0770|025|U|and to stop or reverse signs of early puberty (such as||
0770|026|U|breast/pubic hair growth in girls, pubic hair growth in boys).||
0770|027|U|Histrelin works by reducing the amount of testosterone and||
0770|028|U|estrogen. This medication is used until the doctor decides it is||
0770|029|U|time for puberty to resume.||
0770|030|B|||
0770|031|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0770|032|H|Patient Information Leaflet that comes with the histrelin||
0770|033|H|implant. If you have any questions, ask your doctor.||
0770|034|H|   Your doctor will surgically place the medicated implant under||
0770|035|H|the skin of your upper arm. The implant releases histrelin into||
0770|036|H|your blood slowly and continuously over 12 months. After 12||
0770|037|H|months, your doctor will remove the implant and replace it with a||
0770|038|H|new one. Consult your doctor for details.||
0770|039|H|   It is very important to keep the bandage in place for several||
0770|040|H|days until the surgical incision heals. Keep the incision clean||
0770|041|H|and dry. Avoid bathing and swimming for 24 hours after the||
0770|042|H|procedure. Also avoid any heavy lifting, bumping of the incision||
0770|043|H|site, or physical activity for 7 days after the procedure.||
0770|044|H|   When you first start this medication, new or worsening||
0770|045|H|symptoms may occur. This is a normal response by your body to||
0770|046|H|this drug. Such symptoms should get better after the first month||
0770|047|H|of treatment. Girls being treated for early puberty may notice||
0770|048|H|vaginal bleeding or an increase in breast size or pubic hair.||
0770|049|H|Boys being treated for early puberty may notice an increase in||
0770|050|H|pubic hair. Tell the doctor if the symptoms last or get worse||
0770|051|H|after 1 month.||
0770|052|H|   New or worsening symptoms may also occur at the beginning of||
0770|053|H|treatment for prostate cancer. Tell your doctor right away if you||
0770|054|H|experience any of the following serious side effects: bone pain,||
0770|055|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
0770|056|H|painful/difficult urination, unusual weakness, inability to move.||
0770|057|H|If you have prostate cancer that has spread to the spine or||
0770|058|H|caused problems urinating due to blockage, you may require closer||
0770|059|H|monitoring by your doctor, especially when you first start||
0770|060|H|treatment.||
0770|061|B|||
0770|062|S|SIDE EFFECTS:  Irritation at the implant site (such as bruising,||
0770|063|S|pain, redness), mood swings, or headache may occur. In adults||
0770|064|S|using this medication for prostate cancer, hot flashes||
0770|065|S|(flushing), increased sweating, night sweats, tiredness, swelling||
0770|066|S|of the ankles/feet, or constipation may occur. In girls using||
0770|067|S|this medication for early puberty, breast tenderness or abnormal||
0770|068|S|vaginal bleeding may occur. If any of these effects last or get||
0770|069|S|worse, tell your doctor or pharmacist promptly.||
0770|070|S|   Rarely, breast tenderness/swelling may occur in men and boys||
0770|071|S|as a result of lowered testosterone levels. Shrinking of the||
0770|072|S|testicles and reduced sexual interest/ability may also occur in||
0770|073|S|men. Talk to your doctor if these effects occur.||
0770|074|S|   Remember that this medication has been prescribed because your||
0770|075|S|doctor has judged that the benefit to you is greater than the||
0770|076|S|risk of side effects. Many people using this medication do not||
0770|077|S|have serious side effects.||
0770|078|S|   If you are using this medication for prostate cancer, tell||
0770|079|S|your doctor right away if you have any serious side effects,||
0770|080|S|including: new/worsening bone pain, easily broken bones,||
0770|081|S|increased thirst/urination, mental/mood changes (such as||
0770|082|S|depression), signs of liver disease (such as nausea/vomiting that||
0770|083|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
0770|084|S|eyes/skin, dark urine).||
0770|085|S|   Get medical help right away if you have any very serious side||
0770|086|S|effects, including: chest/jaw/left arm pain, fast/irregular||
0770|087|S|heartbeat, severe dizziness, fainting, weakness on one side of||
0770|088|S|the body, trouble speaking, seizures.||
0770|089|S|   Children using histrelin may be at risk for increased pressure||
0770|090|S|around the brain (intracranial hypertension). Get medical help||
0770|091|S|right away if your child has any of these very serious side||
0770|092|S|effects: nausea/vomiting that doesn't stop, headache that is||
0770|093|S|severe or doesn't go away, eye pain, vision changes (such as||
0770|094|S|blurred/double vision, decreased vision), ringing in the ears.||
0770|095|S|   A very serious allergic reaction to this drug is rare.||
0770|096|S|However, get medical help right away if you notice any symptoms||
0770|097|S|of a serious allergic reaction, including: fever, swollen lymph||
0770|098|S|nodes, rash, itching/swelling (especially of the||
0770|099|S|face/tongue/throat), severe dizziness, trouble breathing.||
0770|100|S|   This is not a complete list of possible side effects. If you||
0770|101|S|notice other effects not listed above, contact your doctor or||
0770|102|S|pharmacist.||
0770|103|S|   In the US -||
0770|104|S|   Call your doctor for medical advice about side effects. You||
0770|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0770|106|S|www.fda.gov/medwatch.||
0770|107|S|   In Canada - Call your doctor for medical advice about side||
0770|108|S|effects. You may report side effects to Health Canada at||
0770|109|S|1-866-234-2345.||
0770|110|B|||
0770|111|P|PRECAUTIONS:  Before using histrelin, tell your doctor or||
0770|112|P|pharmacist if you are allergic to it; or to similar drugs (such||
0770|113|P|as leuprolide); or if you have any other allergies. This product||
0770|114|P|may contain inactive ingredients, which can cause allergic||
0770|115|P|reactions or other problems. Talk to your pharmacist for more||
0770|116|P|details.||
0770|117|P|   Before using this medication, tell your doctor or pharmacist||
0770|118|P|your medical history, especially of: diabetes, heart disease||
0770|119|P|(such as heart attack), stroke, high cholesterol, seizures,||
0770|120|P|mental/mood problems (such as depression).||
0770|121|P|   If you are using this medication for prostate cancer,||
0770|122|P|histrelin may weaken your bones and increase your risk for bone||
0770|123|P|loss (osteoporosis) if used for a long time. Before using this||
0770|124|P|medication, tell your doctor or pharmacist if you have||
0770|125|P|osteoporosis or if you have any of the following risk factors for||
0770|126|P|osteoporosis: long-term alcohol use, smoking, family history of||
0770|127|P|osteoporosis and broken bones, use of certain medications||
0770|128|P|(including corticosteroids such as prednisone, certain||
0770|129|P|anti-seizure drugs such as phenytoin).||
0770|130|P|   Histrelin may cause a condition that affects the heart rhythm||
0770|131|P|(QT prolongation). QT prolongation can rarely cause serious||
0770|132|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0770|133|P|as severe dizziness, fainting) that need medical attention right||
0770|134|P|away.||
0770|135|P|   The risk of QT prolongation may be increased if you have||
0770|136|P|certain medical conditions or are taking other drugs that may||
0770|137|P|cause QT prolongation. Before using histrelin, tell your doctor||
0770|138|P|or pharmacist of all the drugs you take and if you have any of||
0770|139|P|the following conditions: certain heart problems (heart failure,||
0770|140|P|slow heartbeat, QT prolongation in the EKG), family history of||
0770|141|P|certain heart problems (QT prolongation in the EKG, sudden||
0770|142|P|cardiac death).||
0770|143|P|   Low levels of potassium or magnesium in the blood may also||
0770|144|P|increase your risk of QT prolongation. This risk may increase if||
0770|145|P|you use certain drugs (such as diuretics/"water pills") or if you||
0770|146|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0770|147|P|Talk to your doctor about using histrelin safely.||
0770|148|P|   Older adults may be more sensitive to the side effects of this||
0770|149|P|drug, especially QT prolongation (see above).||
0770|150|P|   This medication must not be used during pregnancy. It may harm||
0770|151|P|an unborn baby. Discuss the use of reliable forms of birth||
0770|152|P|control (such as condoms, birth control pills) with your doctor.||
0770|153|P|If you become pregnant or think you may be pregnant, tell your||
0770|154|P|doctor right away.||
0770|155|P|   It is unknown if this medication passes into breast milk.||
0770|156|P|Consult your doctor before breastfeeding.||
0770|157|B|||
0770|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0770|159|I|medications work or increase your risk for serious side effects.||
0770|160|I|This document does not contain all possible drug interactions.||
0770|161|I|Keep a list of all the products you use (including||
0770|162|I|prescription/nonprescription drugs and herbal products) and share||
0770|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
0770|164|I|the dosage of any medicines without your doctor's approval.||
0770|165|B|||
0770|166|O|OVERDOSE:  This implant may be harmful if swallowed. If someone||
0770|167|O|has swallowed it and has serious symptoms such as passing out or||
0770|168|O|trouble breathing, call 911. Otherwise, call a poison control||
0770|169|O|center right away. US residents can call 1-800-222-1222. Canada||
0770|170|O|residents can call 1-844-764-7669.||
0770|171|B|||
0770|172|N|NOTES:  Lab and/or medical tests (such as blood testosterone||
0770|173|N|level, PSA blood test if using for prostate cancer, blood||
0770|174|N|testosterone/estradiol level, height, bone age if using for early||
0770|175|N|puberty, blood glucose, cholesterol/triglyceride levels) should||
0770|176|N|be done while you are using this medication. Keep all medical and||
0770|177|N|lab appointments. Consult your doctor for more details.||
0770|178|N|   If you have radiology tests (X-rays, MRI), the histrelin||
0770|179|N|implant will not be affected or affect the results of these||
0770|180|N|tests. This implant does not show up on X-ray examination.||
0770|181|N|However, make sure radiology personnel and all your doctors know||
0770|182|N|you use this product.||
0770|183|B|||
0770|184|D|MISSED DOSE:  Rarely, the implant can come out of the upper arm.||
0770|185|D|If this occurs or you suspect that this has occurred, call your||
0770|186|D|doctor. Keep all appointments so your doctor can make sure the||
0770|187|D|implant is in place and working.||
0770|188|D|   To help prevent a missed dose, mark your calendar to keep||
0770|189|D|track of when to schedule the placement of your next implant.||
0770|190|B|||
0770|191|R|STORAGE:  Before implantation, the product should be||
0770|192|R|refrigerated. Protect from light and do not freeze.||
0770|193|R|   Do not flush medications down the toilet or pour them into a||
0770|194|R|drain unless instructed to do so. Properly discard this product||
0770|195|R|when it is expired or no longer needed. Consult your pharmacist||
0770|196|R|or local waste disposal company.||
0770|197|B|||
0770|198|A|Information last revised September 2025.||
0770|199|A|Copyright(c) 2025 First Databank, Inc.||
0770|200|B|||
0773|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0773|002|Z|does NOT have all possible information about this product. This||
0773|003|Z|information does not assure that this product is safe, effective,||
0773|004|Z|or appropriate for you. This information is not individual||
0773|005|Z|medical advice and does not substitute for the advice of your||
0773|006|Z|health care professional. Always ask your health care||
0773|007|Z|professional for complete information about this product and your||
0773|008|Z|specific health needs.||
0773|009|B|||
0773|010|T|ANIDULAFUNGIN - INJECTION||
0773|011|F|(ay-NID-ue-la-FUN-jin)||
0773|012|B|||
0773|013|C|COMMON BRAND NAME(S): Eraxis||
0773|014|B|||
0773|015|U|USES:  This medication is used to treat a variety of fungal||
0773|016|U|infections. Anidulafungin belongs to a class of drugs known as||
0773|017|U|echinocandins. It works by stopping the growth of fungi.||
0773|018|B|||
0773|019|H|HOW TO USE:  This medication is given by slow injection into a||
0773|020|H|vein as directed by your doctor, usually once a day. The dosage||
0773|021|H|and length of treatment are based on your medical condition and||
0773|022|H|response to treatment. Children's dosage is also based on weight.||
0773|023|H|   If you are using this medication at home, learn all||
0773|024|H|preparation and usage instructions from your health care||
0773|025|H|professional. Before using, check this product for particles or||
0773|026|H|discoloration. If either is present, do not use the liquid.||
0773|027|H|   Learn how to store and discard medical supplies safely.||
0773|028|H|   Infusion reactions may happen during the infusion of this||
0773|029|H|drug. Tell your doctor right away if you have any symptoms of||
0773|030|H|infusion reactions such as fever, chills, shortness of breath,||
0773|031|H|flushing, or dizziness.||
0773|032|H|   Continue to use this medication until the full prescribed||
0773|033|H|amount is finished, even if symptoms disappear after a few days.||
0773|034|H|Stopping the medication too early may result in a return of the||
0773|035|H|infection.||
0773|036|H|   Tell your doctor if your condition does not get better or if||
0773|037|H|it gets worse.||
0773|038|B|||
0773|039|S|SIDE EFFECTS:  See also How to Use section.||
0773|040|S|   Nausea/vomiting, diarrhea, trouble sleeping, or headache may||
0773|041|S|occur. If any of these effects last or get worse, tell your||
0773|042|S|doctor or pharmacist promptly.||
0773|043|S|   Remember that this medication has been prescribed because your||
0773|044|S|doctor has judged that the benefit to you is greater than the||
0773|045|S|risk of side effects. Many people using this medication do not||
0773|046|S|have serious side effects.||
0773|047|S|   Tell your doctor right away if you have any serious side||
0773|048|S|effects, including: signs of liver disease (such as||
0773|049|S|nausea/vomiting that doesn't stop, loss of appetite, dark urine,||
0773|050|S|stomach/abdominal pain, yellowing eyes/skin), swelling||
0773|051|S|ankles/feet/hands, mental/mood changes (such as confusion,||
0773|052|S|depression), muscle cramps, irregular heartbeat, unusual||
0773|053|S|tiredness, pain/redness/swelling of arms or legs.||
0773|054|S|   A very serious allergic reaction to this drug is rare.||
0773|055|S|However, get medical help right away if you notice any symptoms||
0773|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0773|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0773|058|S|breathing.||
0773|059|S|   This is not a complete list of possible side effects. If you||
0773|060|S|notice other effects not listed above, contact your doctor or||
0773|061|S|pharmacist.||
0773|062|S|   In the US -||
0773|063|S|   Call your doctor for medical advice about side effects. You||
0773|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0773|065|S|www.fda.gov/medwatch.||
0773|066|S|   In Canada - Call your doctor for medical advice about side||
0773|067|S|effects. You may report side effects to Health Canada at||
0773|068|S|1-866-234-2345.||
0773|069|B|||
0773|070|P|PRECAUTIONS:  Before using anidulafungin, tell your doctor or||
0773|071|P|pharmacist if you are allergic to it; or to other echinocandin||
0773|072|P|antifungal drugs (such as caspofungin, micafungin); or if you||
0773|073|P|have any other allergies. This product may contain inactive||
0773|074|P|ingredients (such as polysorbate 80), which can cause allergic||
0773|075|P|reactions or other problems. Talk to your pharmacist for more||
0773|076|P|details.||
0773|077|P|   Before using this medication, tell your doctor or pharmacist||
0773|078|P|your medical history, especially of: liver disease, a certain||
0773|079|P|genetic enzyme problem (hereditary fructose intolerance).||
0773|080|P|   Before having surgery, tell your doctor or dentist about all||
0773|081|P|the products you use (including prescription drugs,||
0773|082|P|nonprescription drugs, and herbal products).||
0773|083|P|   During pregnancy, this medication should be used only when||
0773|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
0773|085|P|   It is unknown if this medication passes into breast milk.||
0773|086|P|Consult your doctor before breastfeeding.||
0773|087|B|||
0773|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0773|089|I|medications work or increase your risk for serious side effects.||
0773|090|I|This document does not contain all possible drug interactions.||
0773|091|I|Keep a list of all the products you use (including||
0773|092|I|prescription/nonprescription drugs and herbal products) and share||
0773|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
0773|094|I|the dosage of any medicines without your doctor's approval.||
0773|095|B|||
0773|096|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0773|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0773|098|O|poison control center right away. US residents can call||
0773|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0773|100|B|||
0773|101|N|NOTES:  Lab and/or medical tests (such as liver function,||
0773|102|N|potassium blood levels) should be done while you are using this||
0773|103|N|medication. Keep all medical and lab appointments. Consult your||
0773|104|N|doctor for more details.||
0773|105|B|||
0773|106|D|MISSED DOSE:  It is important to get each dose of this medication||
0773|107|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0773|108|D|right away for a new dosing schedule. Do not double the dose to||
0773|109|D|catch up.||
0773|110|B|||
0773|111|R|STORAGE:  Consult the product instructions and your pharmacist||
0773|112|R|for storage details. Keep all medications away from children and||
0773|113|R|pets.||
0773|114|R|   Do not flush medications down the toilet or pour them into a||
0773|115|R|drain unless instructed to do so. Properly discard this product||
0773|116|R|when it is expired or no longer needed. Consult your pharmacist||
0773|117|R|or local waste disposal company.||
0773|118|B|||
0773|119|A|Information last revised November 2024.||
0773|120|A|Copyright(c) 2025 First Databank, Inc.||
0773|121|B|||
0776|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0776|002|Z|does NOT have all possible information about this product. This||
0776|003|Z|information does not assure that this product is safe, effective,||
0776|004|Z|or appropriate for you. This information is not individual||
0776|005|Z|medical advice and does not substitute for the advice of your||
0776|006|Z|health care professional. Always ask your health care||
0776|007|Z|professional for complete information about this product and your||
0776|008|Z|specific health needs.||
0776|009|B|||
0776|010|T|NAFCILLIN - INJECTION||
0776|011|F|(naff-SIL-in)||
0776|012|B|||
0776|013|C|COMMON BRAND NAME(S): Unipen||
0776|014|B|||
0776|015|U|USES:  This medication is used to treat a wide variety of||
0776|016|U|bacterial infections. This medication is known as a||
0776|017|U|penicillin-type antibiotic. It works by stopping the growth of||
0776|018|U|bacteria.||
0776|019|B|||
0776|020|H|HOW TO USE:  This medication is given by injection into a vein as||
0776|021|H|directed by your doctor, usually every 4 to 6 hours. The dosage||
0776|022|H|is based on your medical condition and response to treatment.||
0776|023|H|Children's dosage is also based on weight.||
0776|024|H|   If you are giving this medication to yourself at home, learn||
0776|025|H|all preparation and usage instructions from your health care||
0776|026|H|professional. Before using, check this product for particles or||
0776|027|H|discoloration. If either is present, do not use the liquid. Learn||
0776|028|H|how to store and discard medical supplies safely.||
0776|029|H|   If you are using the frozen pre-mixed solution, thaw the||
0776|030|H|medication at room temperature or in the refrigerator. If the||
0776|031|H|container is thawed in the refrigerator, let it come to room||
0776|032|H|temperature before using. Do not thaw by putting in a water bath||
0776|033|H|or microwave. After thawing, shake well and squeeze the container||
0776|034|H|to check for leaks. Discard the solution if the container leaks.||
0776|035|H|Do not re-freeze the solution after thawing.||
0776|036|H|   Give aminoglycosides (such as gentamicin) separately from this||
0776|037|H|medication. Do not mix together in the same IV fluid.||
0776|038|H|   For the best effect, use this antibiotic at evenly spaced||
0776|039|H|times. To help you remember, use this medication at the same||
0776|040|H|time(s) every day.||
0776|041|H|   Continue to use this medication until the full prescribed||
0776|042|H|amount is finished, even if symptoms disappear after a few days.||
0776|043|H|Stopping the medication too early may result in a return of the||
0776|044|H|infection.||
0776|045|H|   Tell your doctor if your condition lasts or gets worse.||
0776|046|B|||
0776|047|S|SIDE EFFECTS:  If this medication is injected into a muscle, pain||
0776|048|S|at the injection site may occur. If this effect lasts or gets||
0776|049|S|worse, notify your doctor or pharmacist promptly.||
0776|050|S|   Remember that this medication has been prescribed because your||
0776|051|S|doctor has judged that the benefit to you is greater than the||
0776|052|S|risk of side effects. Many people using this medication do not||
0776|053|S|have serious side effects.||
0776|054|S|   Tell your doctor right away if you have any serious side||
0776|055|S|effects, including: pain/swelling/skin peeling at injection site||
0776|056|S|(if this drug is injected into a vein), joint/muscle pain, signs||
0776|057|S|of kidney problems (such as change in the amount of urine,||
0776|058|S|pink/bloody/frothy/dark/cloudy urine), extreme tiredness, easy||
0776|059|S|bruising/bleeding, new signs of infection (such as sore throat||
0776|060|S|that doesn't go away, fever, chills), seizures, uncontrolled||
0776|061|S|movements, confusion, irregular heartbeat, muscle cramps,||
0776|062|S|weakness.||
0776|063|S|   This medication may rarely cause a severe intestinal condition||
0776|064|S|due to a bacteria called C. difficile. This condition may occur||
0776|065|S|during treatment or weeks to months after treatment has stopped.||
0776|066|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0776|067|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0776|068|S|stool.||
0776|069|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0776|070|S|products because they may make symptoms worse.||
0776|071|S|   Use of this medication for prolonged or repeated periods may||
0776|072|S|result in oral thrush or a new vaginal yeast infection. Contact||
0776|073|S|your doctor if you notice white patches in your mouth, a change||
0776|074|S|in vaginal discharge, or other new symptoms.||
0776|075|S|   A very serious allergic reaction to this drug is rare.||
0776|076|S|However, get medical help right away if you notice any symptoms||
0776|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0776|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0776|079|S|breathing.||
0776|080|S|   This is not a complete list of possible side effects. If you||
0776|081|S|notice other effects not listed above, contact your doctor or||
0776|082|S|pharmacist.||
0776|083|S|   In the US -||
0776|084|S|   Call your doctor for medical advice about side effects. You||
0776|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0776|086|S|www.fda.gov/medwatch.||
0776|087|S|   In Canada - Call your doctor for medical advice about side||
0776|088|S|effects. You may report side effects to Health Canada at||
0776|089|S|1-866-234-2345.||
0776|090|B|||
0776|091|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0776|092|P|pharmacist if you are allergic to it; or to penicillin or||
0776|093|P|cephalosporin antibiotics; or if you have any other allergies.||
0776|094|P|This product may contain inactive ingredients (such as corn for||
0776|095|P|products containing dextrose), which can cause allergic reactions||
0776|096|P|or other problems. Talk to your pharmacist for more details.||
0776|097|P|   Before using this medication, tell your doctor or pharmacist||
0776|098|P|your medical history, especially of: asthma, kidney disease,||
0776|099|P|liver disease.||
0776|100|P|   This medication contains sodium. This could affect you if you||
0776|101|P|are on a salt-restricted diet or if you have a condition which||
0776|102|P|could be worsened with an increase in salt intake (such as heart||
0776|103|P|failure). Consult your doctor or pharmacist for more information.||
0776|104|P|   Nafcillin may cause live bacterial vaccines (such as typhoid||
0776|105|P|vaccine) to not work well. Tell your health care professional||
0776|106|P|that you are using nafcillin before having any||
0776|107|P|immunizations/vaccinations.||
0776|108|P|   Older adults may be at greater risk for side effects while||
0776|109|P|using this drug.||
0776|110|P|   Newborns and infants may be a greater risk for side effects||
0776|111|P|while using this drug.||
0776|112|P|   During pregnancy, this medication should be used only when||
0776|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
0776|114|P|   This drug passes into breast milk. Consult your doctor before||
0776|115|P|breastfeeding.||
0776|116|B|||
0776|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0776|118|I|medications work or increase your risk for serious side effects.||
0776|119|I|This document does not contain all possible drug interactions.||
0776|120|I|Keep a list of all the products you use (including||
0776|121|I|prescription/nonprescription drugs and herbal products) and share||
0776|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
0776|123|I|the dosage of any medicines without your doctor's approval.||
0776|124|I|   Some products that may interact with this drug include: "blood||
0776|125|I|thinners" (such as warfarin), methotrexate, tetracyclines.||
0776|126|I|   This medication can speed up the removal of other medications||
0776|127|I|from your body, which may affect how they work. Examples of||
0776|128|I|affected drugs include daridorexant, elacestrant, mavacamten,||
0776|129|I|quizartinib, revumenib, among others.||
0776|130|I|   This medication may decrease the effectiveness of hormonal||
0776|131|I|birth control such as pills, patch, or ring. This could cause||
0776|132|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0776|133|I|use reliable backup birth control methods while using this||
0776|134|I|medication. Also tell your doctor if you have any new spotting or||
0776|135|I|breakthrough bleeding, because these may be signs that your birth||
0776|136|I|control is not working well.||
0776|137|I|   This medication may interfere with certain lab tests (such as||
0776|138|I|urine protein tests), possibly causing false test results. Make||
0776|139|I|sure lab personnel and all your doctors know you use this drug.||
0776|140|B|||
0776|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0776|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0776|143|O|poison control center right away. US residents can call||
0776|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0776|145|O|Symptoms of overdose may include: seizures, confusion,||
0776|146|O|mental/mood changes (such as agitation).||
0776|147|B|||
0776|148|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
0776|149|N|complete blood count) may be done while you are using this||
0776|150|N|medication. Keep all medical and lab appointments. Consult your||
0776|151|N|doctor for more details.||
0776|152|B|||
0776|153|D|MISSED DOSE:  It is important to get each dose of this medication||
0776|154|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0776|155|D|right away for a new dosing schedule. Do not double the dose to||
0776|156|D|catch up.||
0776|157|B|||
0776|158|R|STORAGE:  Consult the product instructions and your pharmacist||
0776|159|R|for storage details. Keep all medications away from children and||
0776|160|R|pets.||
0776|161|R|   Do not flush medications down the toilet or pour them into a||
0776|162|R|drain unless instructed to do so. Properly discard this product||
0776|163|R|when it is expired or no longer needed. Consult your pharmacist||
0776|164|R|or local waste disposal company.||
0776|165|B|||
0776|166|A|Information last revised April 2025.||
0776|167|A|Copyright(c) 2025 First Databank, Inc.||
0776|168|B|||
0777|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0777|002|Z|does NOT have all possible information about this product. This||
0777|003|Z|information does not assure that this product is safe, effective,||
0777|004|Z|or appropriate for you. This information is not individual||
0777|005|Z|medical advice and does not substitute for the advice of your||
0777|006|Z|health care professional. Always ask your health care||
0777|007|Z|professional for complete information about this product and your||
0777|008|Z|specific health needs.||
0777|009|B|||
0777|010|T|OXACILLIN - INJECTION||
0777|011|F|(OX-a-SIL-in)||
0777|012|B|||
0777|013|U|USES:  Oxacillin is used to treat a wide variety of bacterial||
0777|014|U|infections. It is a penicillin antibiotic. It works by stopping||
0777|015|U|the growth of bacteria.||
0777|016|B|||
0777|017|H|HOW TO USE:  This medication is given by injection into a vein or||
0777|018|H|into a muscle as directed by your doctor, usually every 4 to 6||
0777|019|H|hours. The dosage is based on your medical condition and response||
0777|020|H|to treatment. Children's dosage is also based on weight.||
0777|021|H|   If you are using this medication at home, learn all||
0777|022|H|preparation and usage instructions from your health care||
0777|023|H|professional. Before using, check this product for particles or||
0777|024|H|discoloration. If either is present, do not use the liquid. Learn||
0777|025|H|how to store and discard medical supplies safely.||
0777|026|H|   If you are using the frozen pre-mixed solution, thaw the||
0777|027|H|container at room temperature or in the refrigerator. If the bag||
0777|028|H|is thawed in the refrigerator, let it sit at room temperature for||
0777|029|H|at least 1 hour before using. Do not thaw by putting in warm/hot||
0777|030|H|water or microwaving. After thawing, shake well and squeeze the||
0777|031|H|container to check for leaks. Discard if the container leaks. Do||
0777|032|H|not re-freeze the solution after thawing.||
0777|033|H|   For the best effect, use this antibiotic at evenly spaced||
0777|034|H|times. To help you remember, use this medication at the same||
0777|035|H|time(s) every day.||
0777|036|H|   Continue to use this medication for the full time prescribed,||
0777|037|H|even if symptoms disappear after a few days. Stopping the||
0777|038|H|medication too early may result in a return of the infection.||
0777|039|H|   Tell your doctor if your condition lasts or gets worse.||
0777|040|B|||
0777|041|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site may||
0777|042|S|occur. If any of these effects last or get worse, tell your||
0777|043|S|doctor or pharmacist promptly.||
0777|044|S|   Remember that this medication has been prescribed because your||
0777|045|S|doctor has judged that the benefit to you is greater than the||
0777|046|S|risk of side effects. Many people using this medication do not||
0777|047|S|have serious side effects.||
0777|048|S|   Tell your doctor right away if you have any serious side||
0777|049|S|effects, including: easy bruising/bleeding, signs of a new||
0777|050|S|infection (such as sore throat that doesn't go away, fever,||
0777|051|S|chills), foamy/pink/bloody/dark urine, signs of kidney problems||
0777|052|S|(such as a change in the amount of urine), swelling||
0777|053|S|hands/ankles/feet, stomach/abdominal pain, nausea/vomiting that||
0777|054|S|doesn't stop, unusual tiredness, yellowing eyes/skin, seizures,||
0777|055|S|uncontrolled movements, mental/mood changes (such as confusion,||
0777|056|S|hallucinations).||
0777|057|S|   This medication may rarely cause a severe intestinal condition||
0777|058|S|due to a bacteria called C. difficile. This condition may occur||
0777|059|S|during treatment or weeks to months after treatment has stopped.||
0777|060|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0777|061|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0777|062|S|stool.||
0777|063|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0777|064|S|products because they may make symptoms worse.||
0777|065|S|   Use of this medication for prolonged or repeated periods may||
0777|066|S|result in oral thrush or a new yeast infection. Contact your||
0777|067|S|doctor if you notice white patches in your mouth, a change in||
0777|068|S|vaginal discharge, or other new symptoms.||
0777|069|S|   A very serious allergic reaction to this drug is rare.||
0777|070|S|However, get medical help right away if you notice any symptoms||
0777|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0777|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0777|073|S|breathing.||
0777|074|S|   This is not a complete list of possible side effects. If you||
0777|075|S|notice other effects not listed above, contact your doctor or||
0777|076|S|pharmacist.||
0777|077|S|   In the US -||
0777|078|S|   Call your doctor for medical advice about side effects. You||
0777|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0777|080|S|www.fda.gov/medwatch.||
0777|081|S|   In Canada - Call your doctor for medical advice about side||
0777|082|S|effects. You may report side effects to Health Canada at||
0777|083|S|1-866-234-2345.||
0777|084|B|||
0777|085|P|PRECAUTIONS:  Before using oxacillin, tell your doctor or||
0777|086|P|pharmacist if you are allergic to it; or to other antibiotics||
0777|087|P|(such as penicillins, cephalosporins); or if you have any other||
0777|088|P|allergies. This product may contain inactive ingredients (such as||
0777|089|P|corn for products containing dextrose), which can cause allergic||
0777|090|P|reactions or other problems. Talk to your pharmacist for more||
0777|091|P|details.||
0777|092|P|   Before using this medication, tell your doctor or pharmacist||
0777|093|P|your medical history, especially of: kidney disease, liver||
0777|094|P|disease.||
0777|095|P|   This medication contains sodium. Consult your doctor or||
0777|096|P|pharmacist if you are on a salt-restricted diet or if you have a||
0777|097|P|condition that could be worsened by an increase in salt intake||
0777|098|P|(such as heart failure, high blood pressure).||
0777|099|P|   Oxacillin may cause live bacterial vaccines (such as typhoid||
0777|100|P|vaccine) to not work well. Tell your health care professional||
0777|101|P|that you are using oxacillin before having any||
0777|102|P|immunizations/vaccinations.||
0777|103|P|   Before having surgery, tell your doctor or dentist about all||
0777|104|P|the products you use (including prescription drugs,||
0777|105|P|nonprescription drugs, and herbal products).||
0777|106|P|   Older adults may be more sensitive to the extra sodium in this||
0777|107|P|medication.||
0777|108|P|   During pregnancy, this medication should be used only when||
0777|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
0777|110|P|   This drug passes into breast milk in small amounts. Consult||
0777|111|P|your doctor before breastfeeding.||
0777|112|B|||
0777|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0777|114|I|medications work or increase your risk for serious side effects.||
0777|115|I|This document does not contain all possible drug interactions.||
0777|116|I|Keep a list of all the products you use (including||
0777|117|I|prescription/nonprescription drugs and herbal products) and share||
0777|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
0777|119|I|the dosage of any medicines without your doctor's approval.||
0777|120|I|   One product that may interact with this drug is: methotrexate.||
0777|121|I|   This medication may interfere with certain lab tests||
0777|122|I|(including certain urine protein tests), possibly causing false||
0777|123|I|test results. Make sure lab personnel and all your doctors know||
0777|124|I|you use this drug.||
0777|125|B|||
0777|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0777|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0777|128|O|poison control center right away. US residents can call||
0777|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0777|130|O|Symptoms of overdose may include: seizures, mental/mood changes||
0777|131|O|(such as agitation, confusion).||
0777|132|B|||
0777|133|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0777|134|N|sodium/potassium blood levels, kidney/liver function) should be||
0777|135|N|done while you are using this medication. Keep all medical and||
0777|136|N|lab appointments.||
0777|137|B|||
0777|138|D|MISSED DOSE:  It is important to get each dose of this medication||
0777|139|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0777|140|D|right away for a new dosing schedule. Do not double the dose to||
0777|141|D|catch up.||
0777|142|B|||
0777|143|R|STORAGE:  Consult the product instructions or your pharmacist for||
0777|144|R|storage details. Keep all medications away from children and||
0777|145|R|pets.||
0777|146|R|   Do not flush medications down the toilet or pour them into a||
0777|147|R|drain unless instructed to do so. Properly discard this product||
0777|148|R|when it is expired or no longer needed. Consult your pharmacist||
0777|149|R|or local waste disposal company.||
0777|150|B|||
0777|151|A|Information last revised January 2025.||
0777|152|A|Copyright(c) 2025 First Databank, Inc.||
0777|153|B|||
0780|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0780|002|Z|does NOT have all possible information about this product. This||
0780|003|Z|information does not assure that this product is safe, effective,||
0780|004|Z|or appropriate for you. This information is not individual||
0780|005|Z|medical advice and does not substitute for the advice of your||
0780|006|Z|health care professional. Always ask your health care||
0780|007|Z|professional for complete information about this product and your||
0780|008|Z|specific health needs.||
0780|009|B|||
0780|010|T|HYDROCORTISONE ACETATE - TOPICAL||
0780|011|F|(HYE-droe-KOR-ti-sone AS-e-tate)||
0780|012|B|||
0780|013|C|COMMON BRAND NAME(S): Cortaid, Nucort||
0780|014|B|||
0780|015|U|USES:  This medication is used to treat a variety of skin||
0780|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0780|017|U|Hydrocortisone acetate reduces the swelling, itching, and redness||
0780|018|U|that can occur in these types of conditions. This medication is a||
0780|019|U|mild corticosteroid.||
0780|020|B|||
0780|021|H|HOW TO USE:  Use this medication on the skin only. However, do||
0780|022|H|not use it on the face, groin, or underarms unless directed to do||
0780|023|H|so by your doctor.||
0780|024|H|   Wash and dry your hands before using. Clean and dry the||
0780|025|H|affected area. Apply a small amount of medication to the affected||
0780|026|H|area and gently rub in, usually 2 to 4 times daily or as directed||
0780|027|H|by your doctor. Do not bandage, cover, or wrap the area unless||
0780|028|H|directed to do so by your doctor. If used in the diaper area on||
0780|029|H|an infant, do not use tight-fitting diapers or plastic pants.||
0780|030|H|   After applying the medication, wash your hands. Avoid getting||
0780|031|H|this medication in the eyes, nose, or mouth. If you get the||
0780|032|H|medication in these areas, rinse with plenty of water.||
0780|033|H|   Use this medication only for the condition for which it was||
0780|034|H|prescribed. Do not use it for longer than prescribed.||
0780|035|H|   Tell your doctor if your condition lasts or gets worse after 2||
0780|036|H|weeks.||
0780|037|B|||
0780|038|S|SIDE EFFECTS:  Stinging, burning, irritation, dryness, or redness||
0780|039|S|at the application site may occur. Acne, excessive hair growth,||
0780|040|S|small red bumps on the skin (folliculitis), skin||
0780|041|S|thinning/discoloration, or stretch marks may also occur. If any||
0780|042|S|of these effects last or get worse, notify your doctor or||
0780|043|S|pharmacist promptly.||
0780|044|S|   If your doctor has directed you to use this medication,||
0780|045|S|remember that your doctor has judged that the benefit to you is||
0780|046|S|greater than the risk of side effects. Many people using this||
0780|047|S|medication do not have serious side effects.||
0780|048|S|   A very serious allergic reaction to this drug is rare.||
0780|049|S|However, get medical help right away if you notice any symptoms||
0780|050|S|of a serious allergic reaction, including: rash, itching/swelling||
0780|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0780|052|S|breathing.||
0780|053|S|   This is not a complete list of possible side effects. If you||
0780|054|S|notice other effects not listed above, contact your doctor or||
0780|055|S|pharmacist.||
0780|056|S|   In the US -||
0780|057|S|   Call your doctor for medical advice about side effects. You||
0780|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0780|059|S|www.fda.gov/medwatch.||
0780|060|S|   In Canada - Call your doctor for medical advice about side||
0780|061|S|effects. You may report side effects to Health Canada at||
0780|062|S|1-866-234-2345.||
0780|063|B|||
0780|064|P|PRECAUTIONS:  Before using hydrocortisone acetate, tell your||
0780|065|P|doctor or pharmacist if you are allergic to it; or to other||
0780|066|P|corticosteroids (such as prednisone, triamcinolone); or if you||
0780|067|P|have any other allergies. This product may contain inactive||
0780|068|P|ingredients (such as sulfites), which can cause allergic||
0780|069|P|reactions or other problems. Talk to your pharmacist for more||
0780|070|P|details.||
0780|071|P|   Before using this medication, tell your doctor or pharmacist||
0780|072|P|your medical history.||
0780|073|P|   Do not use if there is an infection or sore in the area to be||
0780|074|P|treated. Skin infections can become worse when this medication is||
0780|075|P|used. Notify your doctor promptly if redness, swelling, or||
0780|076|P|irritation does not improve.||
0780|077|P|   Children may be more sensitive to the effects of too much||
0780|078|P|corticosteroid medication. Consult your doctor for more details.||
0780|079|P|   During pregnancy, this medication should be used only when||
0780|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
0780|081|P|   It is unknown if this drug passes into breast milk when||
0780|082|P|applied to the skin. Similar medications pass into breast milk||
0780|083|P|when taken by mouth. Consult your doctor before breastfeeding.||
0780|084|B|||
0780|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0780|086|I|medications work or increase your risk for serious side effects.||
0780|087|I|This document does not contain all possible drug interactions.||
0780|088|I|Keep a list of all the products you use (including||
0780|089|I|prescription/nonprescription drugs and herbal products) and share||
0780|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
0780|091|I|the dosage of any medicines without your doctor's approval.||
0780|092|B|||
0780|093|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0780|094|O|has overdosed and has serious symptoms such as passing out or||
0780|095|O|trouble breathing, call 911. Otherwise, call a poison control||
0780|096|O|center right away. US residents can call 1-800-222-1222. Canada||
0780|097|O|residents can call 1-844-764-7669.||
0780|098|B|||
0780|099|N|NOTES:  Do not share this medication with others.||
0780|100|N|   This medication has been prescribed for your current condition||
0780|101|N|only. Do not use it later for other skin problems unless told to||
0780|102|N|do so by your doctor. A different medication may be necessary in||
0780|103|N|those cases.||
0780|104|B|||
0780|105|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0780|106|D|If it is near the time of the next dose, skip the missed dose.||
0780|107|D|Use your next dose at the regular time. Do not double the dose to||
0780|108|D|catch up.||
0780|109|B|||
0780|110|R|STORAGE:  Store at room temperature. Avoid freezing. Keep all||
0780|111|R|medications away from children and pets.||
0780|112|R|   Do not flush medications down the toilet or pour them into a||
0780|113|R|drain unless instructed to do so. Properly discard this product||
0780|114|R|when it is expired or no longer needed. Consult your pharmacist||
0780|115|R|or local waste disposal company.||
0780|116|B|||
0780|117|A|Information last revised October 2024.||
0780|118|A|Copyright(c) 2025 First Databank, Inc.||
0780|119|B|||
0781|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0781|002|Z|does NOT have all possible information about this product. This||
0781|003|Z|information does not assure that this product is safe, effective,||
0781|004|Z|or appropriate for you. This information is not individual||
0781|005|Z|medical advice and does not substitute for the advice of your||
0781|006|Z|health care professional. Always ask your health care||
0781|007|Z|professional for complete information about this product and your||
0781|008|Z|specific health needs.||
0781|009|B|||
0781|010|T|NEOMYCIN/BACITRACIN/POLYMYXIN OINTMENT - OPHTHALMIC||
0781|011|F|(nee-oh-MY-sin/bass-eh-TRAY-sin/paw-lee-MIX-in)||
0781|012|B|||
0781|013|C|COMMON BRAND NAME(S): Neosporin||
0781|014|B|||
0781|015|U|USES:  This medication is used to treat eye infections. This||
0781|016|U|product contains neomycin, bacitracin, and polymyxin, antibiotics||
0781|017|U|that work by stopping the growth of bacteria.||
0781|018|U|   This medication treats only bacterial eye infections. It will||
0781|019|U|not work for other types of eye infections (such as infections||
0781|020|U|caused by viruses, fungi, mycobacteria). Unnecessary use or||
0781|021|U|misuse of any antibiotic can lead to its decreased effectiveness.||
0781|022|B|||
0781|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0781|024|H|directed by your doctor, usually every 3 to 4 hours. The dosage||
0781|025|H|is based on your medical condition and response to treatment.||
0781|026|H|   Do not wear contact lenses while you are using this medicine.||
0781|027|H|Sterilize contact lenses according to manufacturer's directions,||
0781|028|H|and check with your doctor before you begin using them again.||
0781|029|H|   To apply the eye ointment, wash your hands first. To avoid||
0781|030|H|contamination, be careful not to touch the tube tip or let it||
0781|031|H|touch your eye or any other surface. Tilt your head back, look||
0781|032|H|upward, and pull down the lower eyelid to make a pouch. Place a||
0781|033|H|1/2 inch (1.5 centimeters) strip of ointment into the pouch by||
0781|034|H|squeezing the tube gently. Close the eye and roll the eyeball in||
0781|035|H|all directions to spread the medication. Try not to blink and do||
0781|036|H|not rub the eye. Repeat these steps for your other eye if so||
0781|037|H|directed. Wipe the tip of the ointment tube with a clean tissue||
0781|038|H|to remove extra medication before recapping it.||
0781|039|H|   If you are using another kind of eye medication (such as drops||
0781|040|H|or ointments), apply the eye drops first and wait at least 5||
0781|041|H|minutes before applying this eye ointment. Use eye drops before||
0781|042|H|eye ointments to allow the eye drops to enter the eye. If you are||
0781|043|H|using another type of eye ointment, wait at least 10 minutes||
0781|044|H|after using this medication before applying it.||
0781|045|H|   Wait several minutes for your vision to clear before driving||
0781|046|H|or operating machinery.||
0781|047|H|   Use this medication regularly in order to get the most benefit||
0781|048|H|from it. To help you remember, use it at the same time(s) each||
0781|049|H|day. Continue to use this medication for the full time||
0781|050|H|prescribed, even if symptoms disappear after a few days. Stopping||
0781|051|H|the medication too early may result in a return of the infection.||
0781|052|H|   Tell your doctor if your condition does not get better in a||
0781|053|H|few days or if you develop new or worsening eye symptoms (such as||
0781|054|H|discharge, swelling, redness, pain).||
0781|055|B|||
0781|056|S|SIDE EFFECTS:  Stinging/burning of the eyes for 1 to 2 minutes or||
0781|057|S|temporary blurred vision may occur when this medication is||
0781|058|S|applied. If any of these effects last or get worse, tell your||
0781|059|S|doctor or pharmacist promptly.||
0781|060|S|   Remember that this medication has been prescribed because your||
0781|061|S|doctor has judged that the benefit to you is greater than the||
0781|062|S|risk of side effects. Many people using this medication do not||
0781|063|S|have serious side effects.||
0781|064|S|   A very serious allergic reaction to this drug is rare.||
0781|065|S|However, get medical help right away if you notice any symptoms||
0781|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0781|067|S|(especially of the face/tongue/throat/eye/eyelid), severe||
0781|068|S|dizziness, trouble breathing.||
0781|069|S|   This is not a complete list of possible side effects. If you||
0781|070|S|notice other effects not listed above, contact your doctor or||
0781|071|S|pharmacist.||
0781|072|S|   In the US -||
0781|073|S|   Call your doctor for medical advice about side effects. You||
0781|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0781|075|S|www.fda.gov/medwatch.||
0781|076|S|   In Canada - Call your doctor for medical advice about side||
0781|077|S|effects. You may report side effects to Health Canada at||
0781|078|S|1-866-234-2345.||
0781|079|B|||
0781|080|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0781|081|P|pharmacist if you are allergic to neomycin, bacitracin, or||
0781|082|P|polymyxin; or to aminoglycoside antibiotics (such as gentamicin);||
0781|083|P|or if you have any other allergies. This product may contain||
0781|084|P|inactive ingredients, which can cause allergic reactions or other||
0781|085|P|problems. Talk to your pharmacist for more details.||
0781|086|P|   Before using this medication, tell your doctor or pharmacist||
0781|087|P|your medical history, especially of: other eye problems.||
0781|088|P|   After you apply this drug, your vision may become temporarily||
0781|089|P|blurred. Do not drive, use machinery, or do anything that needs||
0781|090|P|clear vision until you can do it safely.||
0781|091|P|   During pregnancy, this medication should be used only when||
0781|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
0781|093|P|   It is unknown if this drug passes into breast milk. Consult||
0781|094|P|your doctor before breastfeeding.||
0781|095|B|||
0781|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0781|097|I|medications work or increase your risk for serious side effects.||
0781|098|I|This document does not contain all possible drug interactions.||
0781|099|I|Keep a list of all the products you use (including||
0781|100|I|prescription/nonprescription drugs and herbal products) and share||
0781|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0781|102|I|the dosage of any medicines without your doctor's approval.||
0781|103|B|||
0781|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0781|105|O|has overdosed and has serious symptoms such as passing out or||
0781|106|O|trouble breathing, call 911. Otherwise, call a poison control||
0781|107|O|center right away. US residents can call 1-800-222-1222. Canada||
0781|108|O|residents can call 1-844-764-7669.||
0781|109|B|||
0781|110|N|NOTES:  Do not share this medication with others.||
0781|111|N|   This medication has been prescribed for your current condition||
0781|112|N|only. Throw away the unused medication after treatment is||
0781|113|N|completed. Do not use it later for another infection unless your||
0781|114|N|doctor tells you to.||
0781|115|B|||
0781|116|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0781|117|D|If it is near the time of the next dose, skip the missed dose.||
0781|118|D|Use your next dose at the regular time. Do not double the dose to||
0781|119|D|catch up.||
0781|120|B|||
0781|121|R|STORAGE:  Store at room temperature. Keep all medications away||
0781|122|R|from children and pets.||
0781|123|R|   Do not flush medications down the toilet or pour them into a||
0781|124|R|drain unless instructed to do so. Properly discard this product||
0781|125|R|when it is expired or no longer needed. Consult your pharmacist||
0781|126|R|or local waste disposal company.||
0781|127|B|||
0781|128|A|Information last revised November 2024.||
0781|129|A|Copyright(c) 2025 First Databank, Inc.||
0781|130|B|||
0782|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0782|002|Z|does NOT have all possible information about this product. This||
0782|003|Z|information does not assure that this product is safe, effective,||
0782|004|Z|or appropriate for you. This information is not individual||
0782|005|Z|medical advice and does not substitute for the advice of your||
0782|006|Z|health care professional. Always ask your health care||
0782|007|Z|professional for complete information about this product and your||
0782|008|Z|specific health needs.||
0782|009|B|||
0782|010|T|BACITRACIN/POLYMYXIN OINTMENT - OPHTHALMIC||
0782|011|F|(BAS-i-TRAY-sin/POL-ee-MIX-in)||
0782|012|B|||
0782|013|C|COMMON BRAND NAME(S): Polysporin||
0782|014|B|||
0782|015|U|USES:  This medication is used to treat eye infections. This||
0782|016|U|product contains bacitracin and polymyxin, antibiotics that work||
0782|017|U|by stopping the growth of bacteria.||
0782|018|U|   This medication treats only bacterial eye infections. It will||
0782|019|U|not work for other types of eye infections (such as infections||
0782|020|U|caused by viruses, fungi, mycobacteria). Unnecessary use or||
0782|021|U|misuse of any antibiotic can lead to its decreased effectiveness.||
0782|022|B|||
0782|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0782|024|H|directed by your doctor, usually every 3 to 4 hours. The dosage||
0782|025|H|is based on your medical condition and response to treatment.||
0782|026|H|   Do not wear contact lenses while you are using this medicine.||
0782|027|H|Sterilize contact lenses according to manufacturer's directions,||
0782|028|H|and check with your doctor before you begin using them again.||
0782|029|H|   To apply the eye ointment, wash your hands first. To avoid||
0782|030|H|contamination, be careful not to touch the tube tip or let it||
0782|031|H|touch your eye or any other surface. Tilt your head back, look||
0782|032|H|upward, and pull down the lower eyelid to make a pouch. Place a||
0782|033|H|1/2 inch (1.5 centimeters) strip of ointment into the pouch by||
0782|034|H|squeezing the tube gently. Close the eye and roll the eyeball in||
0782|035|H|all directions to spread the medication. Try not to blink and do||
0782|036|H|not rub the eye. Repeat these steps for your other eye if so||
0782|037|H|directed. Wipe the tip of the ointment tube with a clean tissue||
0782|038|H|to remove extra medication before recapping it.||
0782|039|H|   If you are using another kind of eye medication (such as drops||
0782|040|H|or ointments), apply the eye drops first and wait at least 5||
0782|041|H|minutes before applying this eye ointment. Use eye drops before||
0782|042|H|eye ointments to allow the eye drops to enter the eye. If you are||
0782|043|H|using another type of eye ointment, wait at least 10 minutes||
0782|044|H|after using this medication before applying it.||
0782|045|H|   Wait several minutes for your vision to clear before driving||
0782|046|H|or operating machinery.||
0782|047|H|   Use this medication regularly in order to get the most benefit||
0782|048|H|from it. To help you remember, use it at the same time(s) each||
0782|049|H|day. Continue to use this medication for the full time||
0782|050|H|prescribed, even if symptoms disappear after a few days. Stopping||
0782|051|H|the medication too early may result in a return of the infection.||
0782|052|H|   Tell your doctor if your condition does not get better in a||
0782|053|H|few days or if you develop new or worsening eye symptoms (such as||
0782|054|H|discharge, swelling, redness, pain).||
0782|055|B|||
0782|056|S|SIDE EFFECTS:  Stinging/burning of the eyes for 1 to 2 minutes or||
0782|057|S|temporary blurred vision may occur when this medication is||
0782|058|S|applied. If any of these effects last or get worse, tell your||
0782|059|S|doctor or pharmacist promptly.||
0782|060|S|   Remember that this medication has been prescribed because your||
0782|061|S|doctor has judged that the benefit to you is greater than the||
0782|062|S|risk of side effects. Many people using this medication do not||
0782|063|S|have serious side effects.||
0782|064|S|   A very serious allergic reaction to this product is rare.||
0782|065|S|However, get medical help right away if you notice any symptoms||
0782|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0782|067|S|(especially of the face/tongue/throat/eye/eyelid), severe||
0782|068|S|dizziness, trouble breathing.||
0782|069|S|   This is not a complete list of possible side effects. If you||
0782|070|S|notice other effects not listed above, contact your doctor or||
0782|071|S|pharmacist.||
0782|072|S|   In the US -||
0782|073|S|   Call your doctor for medical advice about side effects. You||
0782|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0782|075|S|www.fda.gov/medwatch.||
0782|076|S|   In Canada - Call your doctor for medical advice about side||
0782|077|S|effects. You may report side effects to Health Canada at||
0782|078|S|1-866-234-2345.||
0782|079|B|||
0782|080|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0782|081|P|pharmacist if you are allergic to bacitracin or polymyxin; or if||
0782|082|P|you have any other allergies. This product may contain inactive||
0782|083|P|ingredients, which can cause allergic reactions or other||
0782|084|P|problems. Talk to your pharmacist for more details.||
0782|085|P|   Before using this medication, tell your doctor or pharmacist||
0782|086|P|your medical history.||
0782|087|P|   After you apply this drug, your vision may become temporarily||
0782|088|P|blurred. Do not drive, use machinery, or do anything that needs||
0782|089|P|clear vision until you can do it safely.||
0782|090|P|   During pregnancy, this medication should be used only when||
0782|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
0782|092|P|   It is unknown if this drug passes into breast milk. Consult||
0782|093|P|your doctor before breastfeeding.||
0782|094|B|||
0782|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0782|096|I|medications work or increase your risk for serious side effects.||
0782|097|I|This document does not contain all possible drug interactions.||
0782|098|I|Keep a list of all the products you use (including||
0782|099|I|prescription/nonprescription drugs and herbal products) and share||
0782|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
0782|101|I|the dosage of any medicines without your doctor's approval.||
0782|102|B|||
0782|103|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0782|104|O|has overdosed and has serious symptoms such as passing out or||
0782|105|O|trouble breathing, call 911. Otherwise, call a poison control||
0782|106|O|center right away. US residents can call 1-800-222-1222. Canada||
0782|107|O|residents can call 1-844-764-7669.||
0782|108|B|||
0782|109|N|NOTES:  Do not share this medication with others.||
0782|110|N|   This medication has been prescribed for your current condition||
0782|111|N|only. Throw away the unused medication after treatment is||
0782|112|N|completed. Do not use it later for another infection unless your||
0782|113|N|doctor tells you to.||
0782|114|B|||
0782|115|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0782|116|D|If it is near the time of the next dose, skip the missed dose.||
0782|117|D|Use your next dose at the regular time. Do not double the dose to||
0782|118|D|catch up.||
0782|119|B|||
0782|120|R|STORAGE:  Store at room temperature. Keep all medications away||
0782|121|R|from children and pets.||
0782|122|R|   Do not flush medications down the toilet or pour them into a||
0782|123|R|drain unless instructed to do so. Properly discard this product||
0782|124|R|when it is expired or no longer needed. Consult your pharmacist||
0782|125|R|or local waste disposal company.||
0782|126|B|||
0782|127|A|Information last revised November 2024.||
0782|128|A|Copyright(c) 2025 First Databank, Inc.||
0782|129|B|||
0783|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0783|002|Z|does NOT have all possible information about this product. This||
0783|003|Z|information does not assure that this product is safe, effective,||
0783|004|Z|or appropriate for you. This information is not individual||
0783|005|Z|medical advice and does not substitute for the advice of your||
0783|006|Z|health care professional. Always ask your health care||
0783|007|Z|professional for complete information about this product and your||
0783|008|Z|specific health needs.||
0783|009|B|||
0783|010|T|THEOPHYLLINE LIQUID - ORAL||
0783|011|F|(thee-OF-i-lin)||
0783|012|B|||
0783|013|C|COMMON BRAND NAME(S): Elixophyllin||
0783|014|B|||
0783|015|U|USES:  Theophylline is used to treat lung diseases such as asthma||
0783|016|U|and COPD (bronchitis, emphysema). It must be used regularly to||
0783|017|U|prevent wheezing and shortness of breath. This medication belongs||
0783|018|U|to a class of drugs known as xanthines. It works by relaxing the||
0783|019|U|muscles around the airways so that they open up and you can||
0783|020|U|breathe more easily. It also decreases the lungs' response to||
0783|021|U|irritants. Controlling symptoms of breathing problems can||
0783|022|U|decrease time lost from work or school.||
0783|023|U|   This medication must be used regularly to be effective. It||
0783|024|U|does not work right away and should not be used to relieve sudden||
0783|025|U|breathing problems. If sudden shortness of breath occurs, use||
0783|026|U|your quick-relief inhaler as prescribed.||
0783|027|B|||
0783|028|H|HOW TO USE:  Take this medication by mouth with or without food||
0783|029|H|as directed by your doctor, usually 3 to 4 times daily. If this||
0783|030|H|medicine upsets your stomach, you may take it with food. Measure||
0783|031|H|the dose carefully using a special measuring device/cup. Do not||
0783|032|H|use a household spoon because you may not get the correct dose.||
0783|033|H|   The dosage is based on your medical condition, response to||
0783|034|H|treatment, age, weight, lab tests (theophylline blood levels),||
0783|035|H|and other medications you may be taking. Be sure to tell your||
0783|036|H|doctor and pharmacist about all the products you use (including||
0783|037|H|prescription drugs, nonprescription drugs, and herbal products).||
0783|038|H|To reduce your risk of side effects, your doctor may direct you||
0783|039|H|to start this medication at a low dose and gradually increase||
0783|040|H|your dose. Follow your doctor's instructions carefully.||
0783|041|H|   Certain diets (such as high protein/low carbohydrate or high||
0783|042|H|carbohydrate/low protein) may change the effect of theophylline.||
0783|043|H|Tell your doctor if you have any major changes in your diet. Your||
0783|044|H|doctor may need to adjust your dose.||
0783|045|H|   Caffeine and alcohol can increase the side effects of this||
0783|046|H|medication. Avoid drinking large amounts of beverages containing||
0783|047|H|alcohol or caffeine (such as coffee, tea, colas), eating large||
0783|048|H|amounts of chocolate, or taking nonprescription products that||
0783|049|H|contain caffeine.||
0783|050|H|   Take this medication regularly to get the most benefit from||
0783|051|H|it. To help you remember, take it at the same times each day.||
0783|052|H|Keep taking this medication even if you feel well. Do not||
0783|053|H|increase your dose, use this drug more often, or stop using it||
0783|054|H|without first consulting your doctor.||
0783|055|H|   Get medical help right away if your asthma symptoms worsen or||
0783|056|H|if you are using your quick-relief inhaler more than usual or||
0783|057|H|more often than prescribed.||
0783|058|B|||
0783|059|S|SIDE EFFECTS:  Nausea/vomiting, stomach/abdominal pain, headache,||
0783|060|S|trouble sleeping, diarrhea, irritability, restlessness,||
0783|061|S|nervousness, shaking, or increased urination may occur. If any of||
0783|062|S|these effects last or get worse, tell your doctor or pharmacist||
0783|063|S|promptly.||
0783|064|S|   Remember that this medication has been prescribed because your||
0783|065|S|doctor has judged that the benefit to you is greater than the||
0783|066|S|risk of side effects. Many people using this medication do not||
0783|067|S|have serious side effects.||
0783|068|S|   Tell your doctor right away if you have any serious side||
0783|069|S|effects, including: nausea/vomiting that doesn't stop,||
0783|070|S|fast/slow/irregular heartbeat, muscle cramps, fainting,||
0783|071|S|confusion, dizziness.||
0783|072|S|   Get medical help right away if you have any very serious side||
0783|073|S|effects, including: seizures.||
0783|074|S|   A very serious allergic reaction to this drug is rare.||
0783|075|S|However, get medical help right away if you notice any symptoms||
0783|076|S|of a serious allergic reaction, including: rash, itching/swelling||
0783|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0783|078|S|breathing.||
0783|079|S|   This is not a complete list of possible side effects. If you||
0783|080|S|notice other effects not listed above, contact your doctor or||
0783|081|S|pharmacist.||
0783|082|S|   In the US -||
0783|083|S|   Call your doctor for medical advice about side effects. You||
0783|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0783|085|S|www.fda.gov/medwatch.||
0783|086|S|   In Canada - Call your doctor for medical advice about side||
0783|087|S|effects. You may report side effects to Health Canada at||
0783|088|S|1-866-234-2345.||
0783|089|B|||
0783|090|P|PRECAUTIONS:  Before using theophylline, tell your doctor or||
0783|091|P|pharmacist if you are allergic to it; or to other xanthine drugs||
0783|092|P|(such as aminophylline, oxtriphylline, caffeine); or if you have||
0783|093|P|any other allergies. This product may contain inactive||
0783|094|P|ingredients, which can cause allergic reactions or other||
0783|095|P|problems. Talk to your pharmacist for more details.||
0783|096|P|   Before using this medication, tell your doctor or pharmacist||
0783|097|P|your medical history, especially of: stomach/intestinal ulcer,||
0783|098|P|seizures, thyroid disease, heart problems (such as heart failure,||
0783|099|P|irregular heartbeat), liver disease, high blood pressure.||
0783|100|P|   If you get sick or have a fever while taking this medication,||
0783|101|P|tell your doctor right away. The dose of your medicine may need||
0783|102|P|to be adjusted.||
0783|103|P|   This product may contain sugar and/or alcohol. Caution is||
0783|104|P|advised if you have diabetes, liver disease, or any other||
0783|105|P|condition that requires you to limit/avoid these substances in||
0783|106|P|your diet. Ask your doctor or pharmacist about using this product||
0783|107|P|safely.||
0783|108|P|   Before having surgery, tell your doctor or dentist about all||
0783|109|P|the products you use (including prescription drugs,||
0783|110|P|nonprescription drugs, and herbal products).||
0783|111|P|   Older adults may be more sensitive to the side effects of this||
0783|112|P|drug, especially fast/irregular heartbeat, or trouble sleeping.||
0783|113|P|Careful monitoring of side effects and drug blood levels is||
0783|114|P|recommended.||
0783|115|P|   Children may be more sensitive to the side effects of this||
0783|116|P|drug. Careful monitoring of side effects and drug blood levels is||
0783|117|P|recommended.||
0783|118|P|   During pregnancy, this medication should be used only when||
0783|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
0783|120|P|Changes in your body during the last 3 months of pregnancy may||
0783|121|P|affect the amount of this drug in your blood. Your doctor should||
0783|122|P|carefully monitor the amount of drug in your blood, as well as||
0783|123|P|any side effects, so that your dose may be changed if needed.||
0783|124|P|   This drug passes into breast milk and may have undesirable||
0783|125|P|effects on a nursing infant. Consult your doctor before||
0783|126|P|breastfeeding.||
0783|127|B|||
0783|128|I|DRUG INTERACTIONS:  See also How to Use section.||
0783|129|I|   Drug interactions may change how your medications work or||
0783|130|I|increase your risk for serious side effects. This document does||
0783|131|I|not contain all possible drug interactions. Keep a list of all||
0783|132|I|the products you use (including prescription/nonprescription||
0783|133|I|drugs and herbal products) and share it with your doctor and||
0783|134|I|pharmacist. Do not start, stop, or change the dosage of any||
0783|135|I|medicines without your doctor's approval.||
0783|136|I|   A product that may interact with this drug is: riociguat.||
0783|137|I|   Other medications can affect the removal of theophylline from||
0783|138|I|your body, which may affect how theophylline works. Examples||
0783|139|I|include cimetidine, disulfiram, fluvoxamine, interferon,||
0783|140|I|mexiletine, rifampin, drugs used to treat seizures (such as||
0783|141|I|carbamazepine, phenytoin), St. John's wort, viloxazine, among||
0783|142|I|others.||
0783|143|I|   Cigarette/marijuana (cannabis) smoking decreases blood levels||
0783|144|I|of this medication. Tell your doctor if you smoke or if you have||
0783|145|I|recently stopped smoking.||
0783|146|I|   Theophylline is very similar to aminophylline and||
0783|147|I|oxtriphylline. Do not use medications containing aminophylline or||
0783|148|I|oxtriphylline while using theophylline.||
0783|149|I|   This medication may interfere with certain lab tests (such as||
0783|150|I|blood sugar, cholesterol, uric acid, dipyridamole-thallium||
0783|151|I|imaging tests), possibly causing false test results. Make sure||
0783|152|I|lab personnel and all your doctors know you use this drug.||
0783|153|B|||
0783|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0783|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0783|156|O|poison control center right away. US residents can call||
0783|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0783|158|O|Symptoms of overdose may include: nausea/vomiting that doesn't||
0783|159|O|stop, seizures, muscle cramps, fast/irregular heartbeat,||
0783|160|O|mental/mood changes (such as agitation, confusion), vomit that||
0783|161|O|looks like coffee grounds.||
0783|162|B|||
0783|163|N|NOTES:  Do not share this medication with others.||
0783|164|N|   Lab and/or medical tests (such as theophylline blood levels)||
0783|165|N|should be done while you are taking this medication. Keep all||
0783|166|N|medical and lab appointments. Consult your doctor for more||
0783|167|N|details.||
0783|168|B|||
0783|169|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
0783|170|D|next dose at the regular time. Do not double the dose to catch||
0783|171|D|up.||
0783|172|B|||
0783|173|R|STORAGE:  Store at room temperature. Keep all medications away||
0783|174|R|from children and pets.||
0783|175|R|   Do not flush medications down the toilet or pour them into a||
0783|176|R|drain unless instructed to do so. Properly discard this product||
0783|177|R|when it is expired or no longer needed. Consult your pharmacist||
0783|178|R|or local waste disposal company.||
0783|179|B|||
0783|180|M|MEDICAL ALERT:  Your condition can cause complications in a||
0783|181|M|medical emergency. For information about enrolling in MedicAlert,||
0783|182|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0783|183|B|||
0783|184|A|Information last revised July 2025.||
0783|185|A|Copyright(c) 2025 First Databank, Inc.||
0783|186|B|||
0784|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0784|002|Z|does NOT have all possible information about this product. This||
0784|003|Z|information does not assure that this product is safe, effective,||
0784|004|Z|or appropriate for you. This information is not individual||
0784|005|Z|medical advice and does not substitute for the advice of your||
0784|006|Z|health care professional. Always ask your health care||
0784|007|Z|professional for complete information about this product and your||
0784|008|Z|specific health needs.||
0784|009|B|||
0784|010|T|EPINEPHRINE INHALER - ORAL INHALATION||
0784|011|F|(EP-i-NEF-rin)||
0784|012|B|||
0784|013|C|COMMON BRAND NAME(S): Primatene Mist||
0784|014|B|||
0784|015|U|USES:  Epinephrine is used to treat wheezing and shortness of||
0784|016|U|breath that commonly occur with asthma. Controlling these||
0784|017|U|symptoms can decrease time lost from work or school. Epinephrine||
0784|018|U|belongs to a class of drugs known as bronchodilators. It works by||
0784|019|U|relaxing the muscles around the airways so that they open up and||
0784|020|U|you can breathe more easily. Use this medication only if you have||
0784|021|U|been told by your doctor that you have asthma.||
0784|022|B|||
0784|023|H|HOW TO USE:  Read the Patient Information Leaflet for||
0784|024|H|instructions on proper use of this medication and the proper||
0784|025|H|cleaning of the mouthpiece. Consult your doctor or pharmacist if||
0784|026|H|you have any questions.||
0784|027|H|   Shake the canister well before each inhalation. Follow all||
0784|028|H|directions on the product package. If you have any questions, ask||
0784|029|H|your doctor or pharmacist. If you take other asthma drugs by||
0784|030|H|mouth or with inhaling devices, ask your doctor about how to||
0784|031|H|correctly take this medication with your other asthma medicines.||
0784|032|H|   Use this medication exactly as directed in the product||
0784|033|H|package. Inhale by mouth as needed. Take the cap off the||
0784|034|H|mouthpiece. Place the mouthpiece near your mouth and exhale.||
0784|035|H|Place the mouthpiece fully into your mouth and press the inhaler||
0784|036|H|as you breathe in deeply. Hold your breath for as long as||
0784|037|H|comfortable to allow the drug to be absorbed. If more than one||
0784|038|H|inhalation is needed, wait at least 1 full minute between||
0784|039|H|inhalations. Do not use again for at least 4 hours. If your||
0784|040|H|breathing does not get better within 20 minutes after using this||
0784|041|H|medication, or if your breathing gets worse, get medical help||
0784|042|H|right away.||
0784|043|H|   Rinse your mouth after using this medication to help prevent||
0784|044|H|dryness and throat irritation. Do not use more of this medication||
0784|045|H|or use it more often than recommended by the product package or||
0784|046|H|your doctor.||
0784|047|H|   Clean the mouthpiece after each day of use as directed. The||
0784|048|H|mouthpiece should also be cleaned if it is clogged or not working||
0784|049|H|properly.||
0784|050|H|   Caffeine can increase the side effects of this medication.||
0784|051|H|Avoid drinking large amounts of beverages containing caffeine||
0784|052|H|(coffee, tea, colas), eating large amounts of chocolate, or||
0784|053|H|taking nonprescription products that contain caffeine.||
0784|054|H|   Try to keep track of the number of inhalations used from each||
0784|055|H|canister. Discard the canister after you have used the number of||
0784|056|H|inhalations marked on the product package. Do not float the||
0784|057|H|inhaler in water to test if any more drug is left in it.||
0784|058|B|||
0784|059|S|SIDE EFFECTS:  Headache, nausea, vomiting, nervousness,||
0784|060|S|dizziness, shaking (tremor), trouble sleeping, stomach upset,||
0784|061|S|sweating, dry mouth, bad taste, cough, or sore throat may occur.||
0784|062|S|If any of these effects last or get worse, notify your doctor or||
0784|063|S|pharmacist promptly.||
0784|064|S|   If your doctor has directed you to use this medication,||
0784|065|S|remember that your doctor has judged that the benefit to you is||
0784|066|S|greater than the risk of side effects. Many people using this||
0784|067|S|medication do not have serious side effects.||
0784|068|S|   This medication may raise your blood pressure. Check your||
0784|069|S|blood pressure regularly and tell your doctor if the results are||
0784|070|S|high.||
0784|071|S|   Tell your doctor right away if you have any serious side||
0784|072|S|effects, including: fast/pounding/irregular heartbeat, muscle||
0784|073|S|cramps, weakness, mental/mood changes (such as anxiety,||
0784|074|S|hallucinations).||
0784|075|S|   Get medical help right away if you have any very serious side||
0784|076|S|effects, including: chest pain.||
0784|077|S|   Rarely, this medication has caused severe (rarely fatal),||
0784|078|S|sudden worsening of breathing problems/asthma (paradoxical||
0784|079|S|bronchospasm). If you experience sudden wheezing, get medical||
0784|080|S|help right away.||
0784|081|S|   A very serious allergic reaction to this drug is rare.||
0784|082|S|However, get medical help right away if you notice any symptoms||
0784|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0784|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0784|085|S|breathing.||
0784|086|S|   This is not a complete list of possible side effects. If you||
0784|087|S|notice other effects not listed above, contact your doctor or||
0784|088|S|pharmacist.||
0784|089|S|   In the US -||
0784|090|S|   Call your doctor for medical advice about side effects. You||
0784|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0784|092|S|www.fda.gov/medwatch.||
0784|093|S|   In Canada - Call your doctor for medical advice about side||
0784|094|S|effects. You may report side effects to Health Canada at||
0784|095|S|1-866-234-2345.||
0784|096|B|||
0784|097|P|PRECAUTIONS:  Before taking epinephrine, tell your doctor or||
0784|098|P|pharmacist if you are allergic to it; or to similar||
0784|099|P|bronchodilators (such as albuterol, levalbuterol, salmeterol); or||
0784|100|P|to sympathomimetic drugs (such as pseudoephedrine); or if you||
0784|101|P|have any other allergies. This product may contain inactive||
0784|102|P|ingredients, which can cause allergic reactions or other||
0784|103|P|problems. Talk to your pharmacist for more details.||
0784|104|P|   If you have any of the following health problems, consult your||
0784|105|P|doctor or pharmacist before using this product: heart disease||
0784|106|P|(such as high blood pressure, abnormal heart rhythm, coronary||
0784|107|P|insufficiency), seizures, overactive thyroid (hyperthyroidism),||
0784|108|P|diabetes, low blood potassium level (hypokalemia), glaucoma||
0784|109|P|(narrow-angle), Parkinson's disease, urination problems (such as||
0784|110|P|trouble urinating due to enlarged prostate).||
0784|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0784|112|P|can make you more dizzy. Do not drive, use machinery, or do||
0784|113|P|anything that needs alertness until you can do it safely. Limit||
0784|114|P|alcoholic beverages. Talk to your doctor if you are using||
0784|115|P|marijuana (cannabis).||
0784|116|P|   Before having surgery, tell your doctor or dentist about all||
0784|117|P|the products you use (including prescription drugs,||
0784|118|P|nonprescription drugs, and herbal products).||
0784|119|P|   Older adults may be more sensitive to the side effects of this||
0784|120|P|drug, especially the effects on the heart.||
0784|121|P|   During pregnancy, this medication should be used only when||
0784|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
0784|123|P|   It is unknown if this drug passes into breast milk. Consult||
0784|124|P|your doctor before breastfeeding.||
0784|125|B|||
0784|126|I|DRUG INTERACTIONS:  See also How to Use section.||
0784|127|I|   Drug interactions may change how your medications work or||
0784|128|I|increase your risk for serious side effects. This document does||
0784|129|I|not contain all possible drug interactions. Keep a list of all||
0784|130|I|the products you use (such as prescription/nonprescription drugs||
0784|131|I|and herbal products) and share it with your doctor and||
0784|132|I|pharmacist. Do not start, stop, or change the dosage of any||
0784|133|I|medicines without your doctor's approval.||
0784|134|I|   Some products that may interact with this drug are: some beta||
0784|135|I|blockers (such as propranolol), other sympathomimetic drugs (such||
0784|136|I|as ephedrine).||
0784|137|I|   Avoid taking MAO inhibitors (isocarboxazid, linezolid,||
0784|138|I|metaxalone, methylene blue, moclobemide, phenelzine,||
0784|139|I|procarbazine, rasagiline, safinamide, selegiline,||
0784|140|I|tranylcypromine) or tricyclic antidepressants (such as||
0784|141|I|amitriptyline, nortriptyline) within 2 weeks before, during, and||
0784|142|I|after treatment with this medication. In some cases a serious,||
0784|143|I|possibly fatal drug interaction may occur.||
0784|144|B|||
0784|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0784|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0784|147|O|poison control center right away. US residents can call||
0784|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0784|149|O|Symptoms of overdose may include: chest pain,||
0784|150|O|fast/pounding/irregular heartbeat, headache, shaking (tremors),||
0784|151|O|nervousness, weakness, severe dizziness, seizures.||
0784|152|B|||
0784|153|N|NOTES:  Do not share this medication with others.||
0784|154|N|   Avoid allergens, irritants, smoking, and other factors that||
0784|155|N|make asthma worse.||
0784|156|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
0784|157|N|EKG, blood potassium levels) may be done while you are using this||
0784|158|N|medication. Keep all medical and lab appointments. Consult your||
0784|159|N|doctor for more details.||
0784|160|N|   Learn to use a peak flow meter, use it daily, and promptly||
0784|161|N|report worsening asthma (such as readings in the yellow/red range||
0784|162|N|or increased use of quick-relief inhalers).||
0784|163|B|||
0784|164|D|MISSED DOSE:  Not applicable.||
0784|165|B|||
0784|166|R|STORAGE:  Store at room temperature. Do not puncture the canister||
0784|167|R|or expose it to high heat or open flame. Keep all medications||
0784|168|R|away from children and pets.||
0784|169|R|   Do not flush medications down the toilet or pour them into a||
0784|170|R|drain unless instructed to do so. Properly discard this product||
0784|171|R|when it is expired or no longer needed. Consult your pharmacist||
0784|172|R|or local waste disposal company.||
0784|173|B|||
0784|174|M|MEDICAL ALERT:  Your condition can cause complications in a||
0784|175|M|medical emergency. For information about enrolling in MedicAlert,||
0784|176|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0784|177|B|||
0784|178|A|Information last revised July 2025.||
0784|179|A|Copyright(c) 2025 First Databank, Inc.||
0784|180|B|||
0786|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0786|002|Z|does NOT have all possible information about this product. This||
0786|003|Z|information does not assure that this product is safe, effective,||
0786|004|Z|or appropriate for you. This information is not individual||
0786|005|Z|medical advice and does not substitute for the advice of your||
0786|006|Z|health care professional. Always ask your health care||
0786|007|Z|professional for complete information about this product and your||
0786|008|Z|specific health needs.||
0786|009|B|||
0786|010|T|FLUOCINOLONE (SCALP) OIL - TOPICAL||
0786|011|F|(FLOO-oh-SIN-oh-lone)||
0786|012|B|||
0786|013|C|COMMON BRAND NAME(S): Derma-Smoothe-FS||
0786|014|B|||
0786|015|U|USES:  This medication is used to treat scalp psoriasis.||
0786|016|U|Fluocinolone reduces the swelling, itching, and redness that||
0786|017|U|occurs with this condition. This medication is a low- to||
0786|018|U|medium-strength corticosteroid.||
0786|019|B|||
0786|020|H|HOW TO USE:  Shake well before each use. Use this medication on||
0786|021|H|the scalp only.||
0786|022|H|   Wet hair and scalp thoroughly before applying the medication.||
0786|023|H|Apply a thin film to scalp and massage well. Cover the scalp with||
0786|024|H|the shower cap provided for at least 4 hours or overnight.||
0786|025|H|Afterwards, wash off the medication with regular shampoo and||
0786|026|H|rinse well.||
0786|027|H|   After applying the medication, wash your hands. Avoid getting||
0786|028|H|this medication in the eyes, nose, or mouth. If you get the||
0786|029|H|medication in these areas, rinse with plenty of water. Do not use||
0786|030|H|this medication on your face, underarms or groin area.||
0786|031|H|   Use this medication regularly to get the most benefit from it.||
0786|032|H|To help you remember, use it at the same time each day.||
0786|033|H|   Tell your doctor if your condition lasts or gets worse after 2||
0786|034|H|weeks.||
0786|035|B|||
0786|036|S|SIDE EFFECTS:  Stinging, burning, irritation, dryness, or redness||
0786|037|S|at the application site may occur. Acne, excessive hair growth,||
0786|038|S|small red bumps on the skin (folliculitis), skin||
0786|039|S|thinning/discoloration, or stretch marks may also occur. If any||
0786|040|S|of these effects last or get worse, notify your doctor or||
0786|041|S|pharmacist promptly.||
0786|042|S|   Remember that this medication has been prescribed because your||
0786|043|S|doctor has judged that the benefit to you is greater than the||
0786|044|S|risk of side effects. Many people using this medication do not||
0786|045|S|have serious side effects.||
0786|046|S|   Rarely, it is possible this medication will be absorbed from||
0786|047|S|the skin into the bloodstream. This can lead to side effects of||
0786|048|S|too much corticosteroid. These side effects are more likely in||
0786|049|S|children, and in people who use this medication for a long time||
0786|050|S|or over large areas of the skin. Tell your doctor right away if||
0786|051|S|any of the following side effects occur: unusual/extreme||
0786|052|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0786|053|S|thirst/urination, vision problems.||
0786|054|S|   A very serious allergic reaction to this drug is rare.||
0786|055|S|However, get medical help right away if you notice any symptoms||
0786|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0786|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0786|058|S|breathing.||
0786|059|S|   This is not a complete list of possible side effects. If you||
0786|060|S|notice other effects not listed above, contact your doctor or||
0786|061|S|pharmacist.||
0786|062|S|   In the US -||
0786|063|S|   Call your doctor for medical advice about side effects. You||
0786|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0786|065|S|www.fda.gov/medwatch.||
0786|066|S|   In Canada - Call your doctor for medical advice about side||
0786|067|S|effects. You may report side effects to Health Canada at||
0786|068|S|1-866-234-2345.||
0786|069|B|||
0786|070|P|PRECAUTIONS:  Before using fluocinolone, tell your doctor or||
0786|071|P|pharmacist if you are allergic to it; or to other corticosteroids||
0786|072|P|(such as hydrocortisone, prednisone); or if you have any other||
0786|073|P|allergies. This product may contain inactive ingredients (such as||
0786|074|P|peanut oil), which can cause allergic reactions or other||
0786|075|P|problems. Talk to your pharmacist for more details.||
0786|076|P|   Before using this medication, tell your doctor or pharmacist||
0786|077|P|your medical history.||
0786|078|P|   Do not use if there is an infection or sore in the area to be||
0786|079|P|treated. Skin infections can become worse when this medication is||
0786|080|P|used. Notify your doctor promptly if redness, swelling, or||
0786|081|P|irritation does not improve.||
0786|082|P|   Rarely, using corticosteroid medications for a long time or||
0786|083|P|over large areas of skin can make it more difficult for your body||
0786|084|P|to respond to physical stress. Before having surgery or emergency||
0786|085|P|treatment, or if you get a serious illness/injury, tell your||
0786|086|P|doctor or dentist that you are using this medication or have used||
0786|087|P|this medication within the past few months.||
0786|088|P|   Though it is unlikely, this medication may temporarily slow||
0786|089|P|down a child's growth if used for a long time. See the doctor||
0786|090|P|regularly so your child's height can be checked.||
0786|091|P|   During pregnancy, this medication should be used only when||
0786|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
0786|093|P|   It is unknown if this drug passes into breast milk when||
0786|094|P|applied to the skin. Similar medications pass into breast milk||
0786|095|P|when taken by mouth. Consult your doctor before breastfeeding.||
0786|096|B|||
0786|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0786|098|I|medications work or increase your risk for serious side effects.||
0786|099|I|This document does not contain all possible drug interactions.||
0786|100|I|Keep a list of all the products you use (including||
0786|101|I|prescription/nonprescription drugs and herbal products) and share||
0786|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
0786|103|I|the dosage of any medicines without your doctor's approval.||
0786|104|B|||
0786|105|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0786|106|O|has overdosed and has serious symptoms such as passing out or||
0786|107|O|trouble breathing, call 911. Otherwise, call a poison control||
0786|108|O|center right away. US residents can call 1-800-222-1222. Canada||
0786|109|O|residents can call 1-844-764-7669.||
0786|110|B|||
0786|111|N|NOTES:  Do not share this medication with others.||
0786|112|N|   This medication has been prescribed for your current condition||
0786|113|N|only. Do not use it later for other skin problems unless told to||
0786|114|N|do so by your doctor. A different medication may be necessary in||
0786|115|N|those cases.||
0786|116|N|   Lab and/or medical tests (such as adrenal gland function) may||
0786|117|N|be done while you are using this medication, especially if you||
0786|118|N|use this drug for an extended period of time or apply it over||
0786|119|N|large areas of the body. Keep all medical and lab appointments.||
0786|120|N|Consult your doctor for more details.||
0786|121|B|||
0786|122|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0786|123|D|If it is near the time of the next dose, skip the missed dose.||
0786|124|D|Use your next dose at the regular time. Do not double the dose to||
0786|125|D|catch up.||
0786|126|B|||
0786|127|R|STORAGE:  Store at room temperature. Keep all medications away||
0786|128|R|from children and pets.||
0786|129|R|   Do not flush medications down the toilet or pour them into a||
0786|130|R|drain unless instructed to do so. Properly discard this product||
0786|131|R|when it is expired or no longer needed. Consult your pharmacist||
0786|132|R|or local waste disposal company.||
0786|133|B|||
0786|134|A|Information last revised October 2024.||
0786|135|A|Copyright(c) 2025 First Databank, Inc.||
0786|136|B|||
0787|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0787|002|Z|does NOT have all possible information about this product. This||
0787|003|Z|information does not assure that this product is safe, effective,||
0787|004|Z|or appropriate for you. This information is not individual||
0787|005|Z|medical advice and does not substitute for the advice of your||
0787|006|Z|health care professional. Always ask your health care||
0787|007|Z|professional for complete information about this product and your||
0787|008|Z|specific health needs.||
0787|009|B|||
0787|010|T|MICONAZOLE - TOPICAL||
0787|011|F|(mye-KON-a-zole)||
0787|012|B|||
0787|013|C|COMMON BRAND NAME(S): Lotrimin AF, Micatin, Monistat Derm||
0787|014|B|||
0787|015|U|USES:  Miconazole is used to treat skin infections such as||
0787|016|U|athlete's foot, jock itch, ringworm, and other fungal skin||
0787|017|U|infections (candidiasis). This medication is also used to treat a||
0787|018|U|skin condition known as pityriasis (tinea versicolor), a fungal||
0787|019|U|infection that causes a lightening or darkening of the skin of||
0787|020|U|the neck, chest, arms, or legs. Miconazole is an azole antifungal||
0787|021|U|that works by preventing the growth of fungus.||
0787|022|B|||
0787|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0787|024|H|thoroughly dry the area to be treated. Apply this medication to||
0787|025|H|the affected skin, usually twice a day or as directed by your||
0787|026|H|doctor. If you are using the spray form, shake the bottle well||
0787|027|H|before applying. The dosage and length of treatment depends on||
0787|028|H|the type of infection being treated. Do not apply this more often||
0787|029|H|than prescribed. Your condition will not clear faster, but side||
0787|030|H|effects may be increased.||
0787|031|H|   Apply enough medication to cover the affected area and some of||
0787|032|H|the surrounding skin. After applying this medication, wash your||
0787|033|H|hands. Do not wrap, cover or bandage the area unless directed to||
0787|034|H|do so by your doctor.||
0787|035|H|   Do not apply this medication in the eyes, nose, mouth, or||
0787|036|H|vagina.||
0787|037|H|   Use this medication regularly in order to get the most benefit||
0787|038|H|from it. Remember to use it at the same times each day.||
0787|039|H|   Continue to use this medication until the full prescribed||
0787|040|H|amount is finished, even if symptoms disappear after a few days.||
0787|041|H|Stopping the medication too early may result in a return of the||
0787|042|H|infection.||
0787|043|H|   Tell your doctor if your condition lasts or gets worse.||
0787|044|B|||
0787|045|S|SIDE EFFECTS:  Burning, stinging, swelling, irritation, redness,||
0787|046|S|pimple-like bumps, tenderness, or flaking of the treated skin may||
0787|047|S|occur. If any of these effects last or get worse, notify your||
0787|048|S|doctor or pharmacist promptly.||
0787|049|S|   If your doctor has directed you to use this medication,||
0787|050|S|remember that your doctor has judged that the benefit to you is||
0787|051|S|greater than the risk of side effects. Many people using this||
0787|052|S|medication do not have serious side effects.||
0787|053|S|   Tell your doctor right away if you have any serious side||
0787|054|S|effects, including: blistering, oozing, open sores.||
0787|055|S|   A very serious allergic reaction to this drug is rare.||
0787|056|S|However, get medical help right away if you notice any symptoms||
0787|057|S|of a serious allergic reaction, including: rash, itching/swelling||
0787|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0787|059|S|breathing.||
0787|060|S|   This is not a complete list of possible side effects. If you||
0787|061|S|notice other effects not listed above, contact your doctor or||
0787|062|S|pharmacist.||
0787|063|S|   In the US -||
0787|064|S|   Call your doctor for medical advice about side effects. You||
0787|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0787|066|S|www.fda.gov/medwatch.||
0787|067|S|   In Canada - Call your doctor for medical advice about side||
0787|068|S|effects. You may report side effects to Health Canada at||
0787|069|S|1-866-234-2345.||
0787|070|B|||
0787|071|P|PRECAUTIONS:  Before using miconazole, tell your doctor or||
0787|072|P|pharmacist if you are allergic to it; or to other azole||
0787|073|P|antifungals such as clotrimazole, econazole, or ketoconazole; or||
0787|074|P|if you have any other allergies. This product may contain||
0787|075|P|inactive ingredients, which can cause allergic reactions or other||
0787|076|P|problems. Talk to your pharmacist for more details.||
0787|077|P|   Before using this medication, tell your doctor or pharmacist||
0787|078|P|your medical history.||
0787|079|P|   Before having surgery, tell your doctor or dentist about all||
0787|080|P|the products you use (including prescription drugs,||
0787|081|P|nonprescription drugs, and herbal products).||
0787|082|P|   During pregnancy, this medication should be used only when||
0787|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
0787|084|P|   It is unknown if this drug passes into breast milk. Consult||
0787|085|P|your doctor before breastfeeding.||
0787|086|B|||
0787|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0787|088|I|medications work or increase your risk for serious side effects.||
0787|089|I|This document does not contain all possible drug interactions.||
0787|090|I|Keep a list of all the products you use (including||
0787|091|I|prescription/nonprescription drugs and herbal products) and share||
0787|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
0787|093|I|the dosage of any medicines without your doctor's approval.||
0787|094|B|||
0787|095|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0787|096|O|has overdosed and has serious symptoms such as passing out or||
0787|097|O|trouble breathing, call 911. Otherwise, call a poison control||
0787|098|O|center right away. US residents can call 1-800-222-1222. Canada||
0787|099|O|residents can call 1-844-764-7669.||
0787|100|B|||
0787|101|N|NOTES:  Do not share this medication with others.||
0787|102|N|   If your doctor has directed you to use this medication, use it||
0787|103|N|for your current condition only. Do not use it later for another||
0787|104|N|infection unless your doctor tells you to.||
0787|105|N|   When treating pityriasis, this medication may not cause an||
0787|106|N|immediate return to normal skin color. It may take several months||
0787|107|N|after treatment is completed for your natural skin color to||
0787|108|N|return.||
0787|109|B|||
0787|110|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0787|111|D|If it is near the time of the next dose, skip the missed dose.||
0787|112|D|Use your next dose at the regular time. Do not double the dose to||
0787|113|D|catch up.||
0787|114|B|||
0787|115|R|STORAGE:  Different brands of this medication have different||
0787|116|R|storage needs. Check the product package for instructions on how||
0787|117|R|to store your brand, or ask your pharmacist. Keep all medications||
0787|118|R|away from children and pets.||
0787|119|R|   Do not flush medications down the toilet or pour them into a||
0787|120|R|drain unless instructed to do so. Properly discard this product||
0787|121|R|when it is expired or no longer needed. Consult your pharmacist||
0787|122|R|or local waste disposal company.||
0787|123|B|||
0787|124|A|Information last revised September 2024.||
0787|125|A|Copyright(c) 2025 First Databank, Inc.||
0787|126|B|||
0790|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0790|002|Z|does NOT have all possible information about this product. This||
0790|003|Z|information does not assure that this product is safe, effective,||
0790|004|Z|or appropriate for you. This information is not individual||
0790|005|Z|medical advice and does not substitute for the advice of your||
0790|006|Z|health care professional. Always ask your health care||
0790|007|Z|professional for complete information about this product and your||
0790|008|Z|specific health needs.||
0790|009|B|||
0790|010|T|TOBRAMYCIN/LOTEPREDNOL SUSPENSION - OPHTHALMIC||
0790|011|F|(TOE-bra-MYE-sin/LOE-te-PRED-nol)||
0790|012|B|||
0790|013|C|COMMON BRAND NAME(S): Zylet||
0790|014|B|||
0790|015|U|USES:  This medication is used to treat conditions involving||
0790|016|U|swelling (inflammation) of the eyes and to treat or prevent||
0790|017|U|bacterial eye infections. This product contains tobramycin, an||
0790|018|U|antibiotic that works by stopping the growth of bacteria. It also||
0790|019|U|contains loteprednol, an anti-inflammatory corticosteroid that||
0790|020|U|works by reducing swelling, redness, and itching.||
0790|021|U|   This medication treats/prevents only bacterial eye infections.||
0790|022|U|It will not work for other types of eye infections and may worsen||
0790|023|U|them (such as infections caused by viruses, fungi, mycobacteria).||
0790|024|U|Unnecessary use or overuse of any antibiotic can lead to its||
0790|025|U|decreased effectiveness.||
0790|026|B|||
0790|027|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0790|028|H|directed by your doctor, usually every 4 to 6 hours.||
0790|029|H|   To apply eye drops, wash your hands first. To avoid||
0790|030|H|contamination, do not touch the dropper tip or let it touch your||
0790|031|H|eye or any other surface. Shake the bottle well before each dose.||
0790|032|H|   Do not wear contact lenses while you are using this medicine.||
0790|033|H|Sterilize contact lenses according to manufacturer's directions,||
0790|034|H|and check with your doctor before you begin using them again.||
0790|035|H|   Tilt your head back, look upward, and pull down the lower||
0790|036|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0790|037|H|and place one drop into the pouch. Look downward and gently close||
0790|038|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0790|039|H|your eye (near the nose) and apply gentle pressure. This will||
0790|040|H|prevent the medication from draining out. Try not to blink and do||
0790|041|H|not rub your eye. Repeat these steps if your dose is for more||
0790|042|H|than 1 drop and for your other eye if so directed. The dosage is||
0790|043|H|based on your medical condition and response to treatment.||
0790|044|H|   Do not rinse the dropper. Replace the dropper cap after each||
0790|045|H|use.||
0790|046|H|   If you are using another kind of eye medication (such as drops||
0790|047|H|or ointments), wait at least 5 minutes before applying other||
0790|048|H|medications. Use eye drops before eye ointments to allow the eye||
0790|049|H|drops to enter the eye.||
0790|050|H|   Do not use this medication more often than prescribed or for||
0790|051|H|longer than 2 weeks unless directed by your doctor.||
0790|052|H|   Wait several minutes for your vision to clear before driving||
0790|053|H|or operating machinery.||
0790|054|H|   Use this medication regularly in order to get the most benefit||
0790|055|H|from it. To help you remember, use it at the same times each day.||
0790|056|H|Continue to use this medication for the full time prescribed,||
0790|057|H|even if symptoms disappear after a few days. Stopping the||
0790|058|H|medication too early may result in a return of the infection.||
0790|059|H|   Tell your doctor if your condition does not get better in 2||
0790|060|H|days.||
0790|061|B|||
0790|062|S|SIDE EFFECTS:  Stinging/burning of the eyes for 1 to 2 minutes||
0790|063|S|may occur when this medication is applied. Headache may also||
0790|064|S|occur during treatment with this medication. If any of these||
0790|065|S|effects last or get worse, notify your doctor or pharmacist||
0790|066|S|promptly.||
0790|067|S|   Remember that this medication has been prescribed because your||
0790|068|S|doctor has judged that the benefit to you is greater than the||
0790|069|S|risk of side effects. Many people using this medication do not||
0790|070|S|have serious side effects.||
0790|071|S|   Use of this medication for prolonged/repeated periods may||
0790|072|S|result in a new fungal eye infection and may increase your risk||
0790|073|S|for other eye problems (such as glaucoma, cataracts, delayed||
0790|074|S|wound healing). Do not use this medication for longer than||
0790|075|S|prescribed. Tell your doctor right away if any of these unlikely||
0790|076|S|but serious side effects occur: new or worsening eye symptoms||
0790|077|S|(such as discharge, swelling, redness), vision problems, eye||
0790|078|S|pain.||
0790|079|S|   A very serious allergic reaction to this drug is rare.||
0790|080|S|However, get medical help right away if you notice any symptoms||
0790|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0790|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0790|083|S|breathing.||
0790|084|S|   This is not a complete list of possible side effects. If you||
0790|085|S|notice other effects not listed above, contact your doctor or||
0790|086|S|pharmacist.||
0790|087|S|   In the US -||
0790|088|S|   Call your doctor for medical advice about side effects. You||
0790|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0790|090|S|www.fda.gov/medwatch.||
0790|091|S|   In Canada - Call your doctor for medical advice about side||
0790|092|S|effects. You may report side effects to Health Canada at||
0790|093|S|1-866-234-2345.||
0790|094|B|||
0790|095|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0790|096|P|pharmacist if you are allergic to tobramycin or loteprednol; or||
0790|097|P|to aminoglycoside antibiotics (such as gentamicin, neomycin); or||
0790|098|P|to corticosteroids (such as hydrocortisone, prednisone); or if||
0790|099|P|you have any other allergies. This product may contain inactive||
0790|100|P|ingredients (such as preservatives like benzalkonium chloride),||
0790|101|P|which can cause allergic reactions or other problems. Talk to||
0790|102|P|your pharmacist for more details.||
0790|103|P|   Before using this medication, tell your doctor or pharmacist||
0790|104|P|your medical history, especially of: other eye problems (such as||
0790|105|P|glaucoma).||
0790|106|P|   After you apply this drug, your vision may become temporarily||
0790|107|P|blurred or unstable. Do not drive, use machinery, or do anything||
0790|108|P|that needs clear vision until you can do it safely.||
0790|109|P|   During pregnancy, this medication should be used only when||
0790|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
0790|111|P|   It is unknown if this drug passes into breast milk. Consult||
0790|112|P|your doctor before breastfeeding.||
0790|113|B|||
0790|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0790|115|I|medications work or increase your risk for serious side effects.||
0790|116|I|This document does not contain all possible drug interactions.||
0790|117|I|Keep a list of all the products you use (including||
0790|118|I|prescription/nonprescription drugs and herbal products) and share||
0790|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
0790|120|I|the dosage of any medicines without your doctor's approval.||
0790|121|B|||
0790|122|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0790|123|O|has overdosed and has serious symptoms such as passing out or||
0790|124|O|trouble breathing, call 911. Otherwise, call a poison control||
0790|125|O|center right away. US residents can call 1-800-222-1222. Canada||
0790|126|O|residents can call 1-844-764-7669.||
0790|127|B|||
0790|128|N|NOTES:  Do not share this medication with others.||
0790|129|N|   This medication has been prescribed for your current condition||
0790|130|N|only. Throw away the unused medication after treatment is||
0790|131|N|completed. Do not use it later for another infection unless your||
0790|132|N|doctor tells you to.||
0790|133|N|   If you use this medication for 10 days or longer, lab and/or||
0790|134|N|medical tests (such as eye exams) should be done while you are||
0790|135|N|using this medication. Keep all medical and lab appointments.||
0790|136|N|Consult your doctor for more details.||
0790|137|B|||
0790|138|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0790|139|D|If it is near the time of the next dose, skip the missed dose.||
0790|140|D|Use your next dose at the regular time. Do not double the dose to||
0790|141|D|catch up.||
0790|142|B|||
0790|143|R|STORAGE:  Store the bottle upright at room temperature. Do not||
0790|144|R|freeze. Throw away this medication and do not use it if the||
0790|145|R|solution turns brown or cloudy or contains particles. Keep all||
0790|146|R|medications away from children and pets.||
0790|147|R|   Do not flush medications down the toilet or pour them into a||
0790|148|R|drain unless instructed to do so. Properly discard this product||
0790|149|R|when it is expired or no longer needed. Consult your pharmacist||
0790|150|R|or local waste disposal company.||
0790|151|B|||
0790|152|A|Information last revised February 2025.||
0790|153|A|Copyright(c) 2025 First Databank, Inc.||
0790|154|B|||
0791|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0791|002|Z|does NOT have all possible information about this product. This||
0791|003|Z|information does not assure that this product is safe, effective,||
0791|004|Z|or appropriate for you. This information is not individual||
0791|005|Z|medical advice and does not substitute for the advice of your||
0791|006|Z|health care professional. Always ask your health care||
0791|007|Z|professional for complete information about this product and your||
0791|008|Z|specific health needs.||
0791|009|B|||
0791|010|T|CEFOTAXIME - INJECTION||
0791|011|F|(SEF-oh-TAX-eem)||
0791|012|B|||
0791|013|C|COMMON BRAND NAME(S): Claforan||
0791|014|B|||
0791|015|U|USES:  Cefotaxime is used to treat a wide variety of bacterial||
0791|016|U|infections. It may also be used to prevent infection from certain||
0791|017|U|surgeries. This medication belongs to a class of drugs known as||
0791|018|U|cephalosporin antibiotics. It works by stopping the growth of||
0791|019|U|bacteria.||
0791|020|B|||
0791|021|H|HOW TO USE:  This medication is given by injection into a muscle||
0791|022|H|or vein as directed by your doctor. If given by injection into a||
0791|023|H|vein, inject the drug slowly over at least 3 minutes to avoid||
0791|024|H|possible serious side effects (such as irregular heartbeat). The||
0791|025|H|dosage is based on your medical condition and response to||
0791|026|H|treatment.||
0791|027|H|   If you are using this medication at home, learn all||
0791|028|H|preparation and usage instructions from your health care||
0791|029|H|professional. Before using, check this product for particles or||
0791|030|H|discoloration. If either is present, do not use the liquid. Learn||
0791|031|H|how to store and discard medical supplies safely.||
0791|032|H|   If you are using the frozen pre-mixed solution, thaw the bag||
0791|033|H|at room temperature or in the refrigerator. If the bag is thawed||
0791|034|H|in the refrigerator, let it sit at room temperature at least 1||
0791|035|H|hour before using. Do not thaw by putting in a water bath or||
0791|036|H|microwaving. After thawing, shake well and squeeze the bag to||
0791|037|H|check for leaks. Discard solution if the bag leaks. Do not||
0791|038|H|re-freeze the solution after thawing.||
0791|039|H|   For the best effect, use this antibiotic at evenly spaced||
0791|040|H|times. To help you remember, use this medication at the same||
0791|041|H|time(s) every day.||
0791|042|H|   Continue to use this medication for the full time prescribed,||
0791|043|H|even if symptoms disappear after a few days. Stopping the||
0791|044|H|medication too early may result in a return of the infection.||
0791|045|H|   Tell your doctor if your condition lasts or gets worse.||
0791|046|B|||
0791|047|S|SIDE EFFECTS:  Swelling, redness, or pain at the injection site||
0791|048|S|may occur. If any of these effects last or get worse, tell your||
0791|049|S|doctor or pharmacist promptly.||
0791|050|S|   Remember that this medication has been prescribed because your||
0791|051|S|doctor has judged that the benefit to you is greater than the||
0791|052|S|risk of side effects. Many people using this medication do not||
0791|053|S|have serious side effects.||
0791|054|S|   Tell your doctor right away if you have any serious side||
0791|055|S|effects, including: easy bruising/bleeding, unusual tiredness,||
0791|056|S|uncontrollable movements, mental/mood changes (such as||
0791|057|S|confusion), seizures, signs of kidney problems (such as change in||
0791|058|S|the amount of urine), signs of liver problems (such as||
0791|059|S|nausea/vomiting that doesn't stop, loss of appetite,||
0791|060|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0791|061|S|   Get medical help right away if you have any very serious side||
0791|062|S|effects, including: fast/slow/irregular heartbeat.||
0791|063|S|   This medication may rarely cause a severe intestinal condition||
0791|064|S|due to a bacteria called C. difficile. This condition may occur||
0791|065|S|during treatment or weeks to months after treatment has stopped.||
0791|066|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0791|067|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0791|068|S|stool.||
0791|069|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0791|070|S|products because they may make symptoms worse.||
0791|071|S|   Use of this medication for prolonged or repeated periods may||
0791|072|S|result in oral thrush or a new yeast infection. Contact your||
0791|073|S|doctor if you notice white patches in your mouth, a change in||
0791|074|S|vaginal discharge, or other new symptoms.||
0791|075|S|   A very serious allergic reaction to this drug is rare.||
0791|076|S|However, get medical help right away if you notice any symptoms||
0791|077|S|of a serious allergic reaction, including: rash, itching/swelling||
0791|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0791|079|S|breathing.||
0791|080|S|   This is not a complete list of possible side effects. If you||
0791|081|S|notice other effects not listed above, contact your doctor or||
0791|082|S|pharmacist.||
0791|083|S|   In the US -||
0791|084|S|   Call your doctor for medical advice about side effects. You||
0791|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0791|086|S|www.fda.gov/medwatch.||
0791|087|S|   In Canada - Call your doctor for medical advice about side||
0791|088|S|effects. You may report side effects to Health Canada at||
0791|089|S|1-866-234-2345.||
0791|090|B|||
0791|091|P|PRECAUTIONS:  Before using cefotaxime, tell your doctor or||
0791|092|P|pharmacist if you are allergic to it; or to other antibiotics||
0791|093|P|(such as penicillins, other cephalosporins); or if you have any||
0791|094|P|other allergies. This product may contain inactive ingredients,||
0791|095|P|which can cause allergic reactions or other problems. Talk to||
0791|096|P|your pharmacist for more details.||
0791|097|P|   Before using this medication, tell your doctor or pharmacist||
0791|098|P|your medical history, especially of: kidney disease,||
0791|099|P|stomach/intestinal diseases (such as colitis).||
0791|100|P|   Cefotaxime may cause live bacterial vaccines (such as typhoid||
0791|101|P|vaccine) to not work well. Tell your health care professional||
0791|102|P|that you are using cefotaxime before having any||
0791|103|P|immunizations/vaccinations.||
0791|104|P|   Before having surgery, tell your doctor or dentist about all||
0791|105|P|the products you use (including prescription drugs,||
0791|106|P|nonprescription drugs, and herbal products).||
0791|107|P|   Tell your doctor if you are pregnant before using this||
0791|108|P|medication.||
0791|109|P|   This medication passes into breast milk in small amounts and||
0791|110|P|is unlikely to harm a nursing infant. Consult your doctor before||
0791|111|P|breastfeeding.||
0791|112|B|||
0791|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0791|114|I|medications work or increase your risk for serious side effects.||
0791|115|I|This document does not contain all possible drug interactions.||
0791|116|I|Keep a list of all the products you use (including||
0791|117|I|prescription/nonprescription drugs and herbal products) and share||
0791|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
0791|119|I|the dosage of any medicines without your doctor's approval.||
0791|120|I|   This medication may interfere with certain lab tests||
0791|121|I|(including certain urine glucose tests), possibly causing false||
0791|122|I|test results. Make sure lab personnel and all your doctors know||
0791|123|I|you use this drug.||
0791|124|B|||
0791|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0791|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0791|127|O|poison control center right away. US residents can call||
0791|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0791|129|O|Symptoms of overdose may include: seizures.||
0791|130|B|||
0791|131|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0791|132|N|kidney function) should be done while you are using this||
0791|133|N|medication. Keep all medical and lab appointments.||
0791|134|B|||
0791|135|D|MISSED DOSE:  It is important to get each dose of this medication||
0791|136|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0791|137|D|right away for a new dosing schedule. Do not double the dose to||
0791|138|D|catch up.||
0791|139|B|||
0791|140|R|STORAGE:  Consult the product instructions and your pharmacist||
0791|141|R|for storage details. Keep all medications away from children and||
0791|142|R|pets.||
0791|143|R|   Do not flush medications down the toilet or pour them into a||
0791|144|R|drain unless instructed to do so. Properly discard this product||
0791|145|R|when it is expired or no longer needed. Consult your pharmacist||
0791|146|R|or local waste disposal company.||
0791|147|B|||
0791|148|A|Information last revised January 2025.||
0791|149|A|Copyright(c) 2025 First Databank, Inc.||
0791|150|B|||
0792|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0792|002|Z|does NOT have all possible information about this product. This||
0792|003|Z|information does not assure that this product is safe, effective,||
0792|004|Z|or appropriate for you. This information is not individual||
0792|005|Z|medical advice and does not substitute for the advice of your||
0792|006|Z|health care professional. Always ask your health care||
0792|007|Z|professional for complete information about this product and your||
0792|008|Z|specific health needs.||
0792|009|B|||
0792|010|T|PERPHENAZINE - ORAL||
0792|011|F|(per-FEN-a-zeen)||
0792|012|B|||
0792|013|C|COMMON BRAND NAME(S): Trilafon||
0792|014|B|||
0792|015|W|WARNING:  There may be a slightly increased risk of serious,||
0792|016|W|possibly fatal side effects (such as heart failure,||
0792|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
0792|018|W|by older adults with dementia. This medication is not approved||
0792|019|W|for the treatment of dementia-related behavior problems. Discuss||
0792|020|W|the risks and benefits of this medication, as well as other||
0792|021|W|effective and possibly safer treatments for dementia-related||
0792|022|W|behavior problems, with the doctor.||
0792|023|B|||
0792|024|U|USES:  This medication is used to treat certain mental/mood||
0792|025|U|disorders (such as schizophrenia, manic phase of bipolar||
0792|026|U|disorder, schizoaffective disorder). Perphenazine belongs to a||
0792|027|U|class of drugs known as antipsychotics. It works by helping to||
0792|028|U|restore the balance of certain natural substances in the brain.||
0792|029|B|||
0792|030|H|HOW TO USE:  Take this medication by mouth with or without food||
0792|031|H|as directed by your doctor, usually 1 to 3 times a day.||
0792|032|H|   The dosage is based on your medical condition and response to||
0792|033|H|treatment. Your doctor may direct you to take a low dose at||
0792|034|H|first, gradually increasing the dose to lower the chance of side||
0792|035|H|effects (such as muscle spasms). Follow your doctor's directions||
0792|036|H|carefully.||
0792|037|H|   Take this medication regularly to get the most benefit from||
0792|038|H|it. To help you remember, take it at the same time(s) each day.||
0792|039|H|   Although you may notice some medication effects soon after||
0792|040|H|starting, it may take as much as 4 to 6 weeks of regular use to||
0792|041|H|see the full benefit. Do not stop taking this medication without||
0792|042|H|consulting your doctor. Your condition may become worse when the||
0792|043|H|drug is suddenly stopped. Your dose may need to be gradually||
0792|044|H|decreased.||
0792|045|H|   Tell your doctor if your condition does not get better or if||
0792|046|H|it gets worse.||
0792|047|B|||
0792|048|S|SIDE EFFECTS:  Drowsiness, constipation, dry mouth, dizziness,||
0792|049|S|lightheadedness, blurred vision, tiredness, or unexplained weight||
0792|050|S|gain may occur. If any of these effects last or get worse, notify||
0792|051|S|your doctor or pharmacist promptly.||
0792|052|S|   Dizziness and lightheadedness can increase the risk of||
0792|053|S|falling. Get up slowly when rising from a sitting or lying||
0792|054|S|position.||
0792|055|S|   Tell your doctor right away if any of these side effects||
0792|056|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
0792|057|S|mask-like expression of the face, drooling/trouble swallowing, or||
0792|058|S|shuffling walk. Your doctor may prescribe another medication to||
0792|059|S|decrease these side effects.||
0792|060|S|   Remember that this medication has been prescribed because your||
0792|061|S|doctor has judged that the benefit to you is greater than the||
0792|062|S|risk of side effects. Many people using this medication do not||
0792|063|S|have serious side effects.||
0792|064|S|   This medication may cause a condition known as tardive||
0792|065|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0792|066|S|your doctor right away if you develop any involuntary/repetitive||
0792|067|S|muscle movements such as lip smacking/puckering, tongue||
0792|068|S|thrusting, chewing, or finger/toe movements.||
0792|069|S|   In rare cases, perphenazine may increase your level of a||
0792|070|S|certain chemical made by the body (prolactin). For females, this||
0792|071|S|increase in prolactin may result in unwanted breast milk,||
0792|072|S|missed/stopped periods, or difficulty becoming pregnant. For||
0792|073|S|males, it may result in decreased sexual ability, inability to||
0792|074|S|produce sperm, or enlarged breasts. If you develop any of these||
0792|075|S|symptoms, tell your doctor right away.||
0792|076|S|   Tell your doctor right away if you have any serious side||
0792|077|S|effects, including: nausea that doesn't stop, difficulty||
0792|078|S|urinating, easy bruising/bleeding, slow heartbeat, signs of||
0792|079|S|infection (such as sore throat that doesn't go away, chills),||
0792|080|S|severe muscle spasm/cramping (such as twisting neck, arching||
0792|081|S|back, eyes rolling up), seizures, stomach/abdominal pain,||
0792|082|S|yellowing eyes/skin.||
0792|083|S|   Get medical help right away if you have any very serious side||
0792|084|S|effects, including: fast/irregular heartbeat, severe dizziness,||
0792|085|S|fainting.||
0792|086|S|   This medication may rarely cause a very serious condition||
0792|087|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0792|088|S|right away if you have any of the following symptoms: fever,||
0792|089|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
0792|090|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
0792|091|S|signs of kidney problems (such as change in the amount of urine).||
0792|092|S|   A very serious allergic reaction to this drug is rare.||
0792|093|S|However, get medical help right away if you notice any symptoms||
0792|094|S|of a serious allergic reaction, including: rash, itching/swelling||
0792|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0792|096|S|breathing.||
0792|097|S|   This is not a complete list of possible side effects. If you||
0792|098|S|notice other effects not listed above, contact your doctor or||
0792|099|S|pharmacist.||
0792|100|S|   In the US -||
0792|101|S|   Call your doctor for medical advice about side effects. You||
0792|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0792|103|S|www.fda.gov/medwatch.||
0792|104|S|   In Canada - Call your doctor for medical advice about side||
0792|105|S|effects. You may report side effects to Health Canada at||
0792|106|S|1-866-234-2345.||
0792|107|B|||
0792|108|P|PRECAUTIONS:  Before taking perphenazine, tell your doctor or||
0792|109|P|pharmacist if you are allergic to it, or to other phenothiazines||
0792|110|P|(such as chlorpromazine, fluphenazine), or if you have any other||
0792|111|P|allergies. This product may contain inactive ingredients, which||
0792|112|P|can cause allergic reactions or other problems. Talk to your||
0792|113|P|pharmacist for more details.||
0792|114|P|   Before using this medication, tell your doctor or pharmacist||
0792|115|P|your medical history, especially of: decreased bone marrow||
0792|116|P|function, serious head injury, liver problems, nervous system||
0792|117|P|problem (such as drug/alcohol overdose), Parkinson's disease,||
0792|118|P|history of alcohol/substance abuse, low blood pressure, breathing||
0792|119|P|problems (such as asthma, emphysema), breast cancer,||
0792|120|P|fast/irregular heartbeat, heart valve problems, a certain adrenal||
0792|121|P|gland tumor (pheochromocytoma), restless legs syndrome, seizure||
0792|122|P|disorder, a certain severe reaction to other medications||
0792|123|P|(neuroleptic malignant syndrome), difficulty urinating (such as||
0792|124|P|due to prostate problems).||
0792|125|P|   Perphenazine may cause a condition that affects the heart||
0792|126|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0792|127|P|serious (rarely fatal) fast/irregular heartbeat and other||
0792|128|P|symptoms (such as severe dizziness, fainting) that need medical||
0792|129|P|attention right away.||
0792|130|P|   The risk of QT prolongation may be increased if you have||
0792|131|P|certain medical conditions or are taking other drugs that may||
0792|132|P|cause QT prolongation. Before using perphenazine, tell your||
0792|133|P|doctor or pharmacist of all the drugs you take and if you have||
0792|134|P|any of the following conditions: certain heart problems (heart||
0792|135|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0792|136|P|history of certain heart problems (QT prolongation in the EKG,||
0792|137|P|sudden cardiac death).||
0792|138|P|   Low levels of potassium or magnesium in the blood may also||
0792|139|P|increase your risk of QT prolongation. This risk may increase if||
0792|140|P|you use certain drugs (such as diuretics "water pills") or if you||
0792|141|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0792|142|P|Talk to your doctor about using perphenazine safely.||
0792|143|P|   This drug may make you dizzy or drowsy or blur your vision.||
0792|144|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0792|145|P|drowsy. Do not drive, use machinery, or do anything that needs||
0792|146|P|alertness or clear vision until you can do it safely. Avoid||
0792|147|P|alcoholic beverages. Talk to your doctor if you are using||
0792|148|P|marijuana (cannabis).||
0792|149|P|   This medication may make you more sensitive to the sun. Limit||
0792|150|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0792|151|P|sunscreen and wear protective clothing when outdoors. Tell your||
0792|152|P|doctor right away if you get sunburned or have skin||
0792|153|P|blisters/redness.||
0792|154|P|   Before having surgery, tell your doctor or dentist about all||
0792|155|P|the products you use (including prescription drugs,||
0792|156|P|nonprescription drugs, and herbal products).||
0792|157|P|   Perphenazine may make you sweat less, making you more likely||
0792|158|P|to get heat stroke. Avoid doing things that may cause you to||
0792|159|P|overheat, such as hard work or exercise in hot weather, or using||
0792|160|P|hot tubs. When the weather is hot, drink a lot of fluids and||
0792|161|P|dress lightly. If you overheat, quickly look for a place to cool||
0792|162|P|down and rest. Get medical help right away if you have a fever||
0792|163|P|that does not go away, mental/mood changes, headache, or||
0792|164|P|dizziness.||
0792|165|P|   Children may be more sensitive to the side effects of this||
0792|166|P|drug, especially uncontrolled movements.||
0792|167|P|   Older adults may be more sensitive to the side effects of this||
0792|168|P|drug, especially dizziness, lightheadedness, drowsiness, muscle||
0792|169|P|spasm/stiffness, tardive dyskinesia, and QT prolongation (see||
0792|170|P|above). Drowsiness, dizziness, and lightheadedness can increase||
0792|171|P|the risk of falling.||
0792|172|P|   During pregnancy, this medication should be used only when||
0792|173|P|clearly needed. Babies born to mothers who have used this drug||
0792|174|P|during the last 3 months of pregnancy may rarely develop symptoms||
0792|175|P|including muscle stiffness or shakiness, drowsiness,||
0792|176|P|feeding/breathing difficulties, or constant crying. If you notice||
0792|177|P|any of these symptoms in your newborn especially during their||
0792|178|P|first month, tell the doctor right away.||
0792|179|P|   Since untreated mental/mood problems (such as schizophrenia,||
0792|180|P|bipolar disorder, schizoaffective disorder) can be a serious||
0792|181|P|condition, do not stop taking this medication unless directed by||
0792|182|P|your doctor. If you are planning pregnancy, become pregnant, or||
0792|183|P|think you may be pregnant, immediately discuss with your doctor||
0792|184|P|the benefits and risks of using this medication during pregnancy.||
0792|185|P|   Perphenazine passes into breast milk and may have undesirable||
0792|186|P|effects on a nursing infant. Consult your doctor before||
0792|187|P|breastfeeding.||
0792|188|B|||
0792|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0792|190|I|medications work or increase your risk for serious side effects.||
0792|191|I|This document does not contain all possible drug interactions.||
0792|192|I|Keep a list of all the products you use (including||
0792|193|I|prescription/nonprescription drugs and herbal products) and share||
0792|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
0792|195|I|the dosage of any medicines without your doctor's approval.||
0792|196|I|   Tell your doctor or pharmacist if you are taking other||
0792|197|I|products that cause drowsiness such as opioid pain or cough||
0792|198|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0792|199|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0792|200|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0792|201|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0792|202|I|diphenhydramine).||
0792|203|I|   Check the labels on all your medicines (such as allergy or||
0792|204|I|cough-and-cold products) because they may contain ingredients||
0792|205|I|that cause drowsiness. Ask your pharmacist about using those||
0792|206|I|products safely.||
0792|207|B|||
0792|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0792|209|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0792|210|O|poison control center right away. US residents can call||
0792|211|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0792|212|O|Symptoms of overdose may include: slow/shallow breathing,||
0792|213|O|inability to wake up (coma).||
0792|214|B|||
0792|215|N|NOTES:  Do not share this medication with others.||
0792|216|N|   Lab and/or medical tests (such as complete blood count, liver||
0792|217|N|function, eye exams) should be done while you are taking this||
0792|218|N|medication. Keep all medical and lab appointments. Consult your||
0792|219|N|doctor for more details.||
0792|220|B|||
0792|221|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0792|222|D|remember. If it is near the time of the next dose, skip the||
0792|223|D|missed dose. Take your next dose at the regular time. Do not||
0792|224|D|double the dose to catch up.||
0792|225|B|||
0792|226|R|STORAGE:  Store at room temperature away from light and moisture.||
0792|227|R|Do not store in the bathroom. Keep all medications away from||
0792|228|R|children and pets.||
0792|229|R|   Do not flush medications down the toilet or pour them into a||
0792|230|R|drain unless instructed to do so. Properly discard this product||
0792|231|R|when it is expired or no longer needed. Consult your pharmacist||
0792|232|R|or local waste disposal company.||
0792|233|B|||
0792|234|A|Information last revised October 2025.||
0792|235|A|Copyright(c) 2025 First Databank, Inc.||
0792|236|B|||
0793|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0793|002|Z|does NOT have all possible information about this product. This||
0793|003|Z|information does not assure that this product is safe, effective,||
0793|004|Z|or appropriate for you. This information is not individual||
0793|005|Z|medical advice and does not substitute for the advice of your||
0793|006|Z|health care professional. Always ask your health care||
0793|007|Z|professional for complete information about this product and your||
0793|008|Z|specific health needs.||
0793|009|B|||
0793|010|T|FLUTICASONE/SALMETEROL HFA INHALER - ORAL INHALATION||
0793|011|F|(floo-TIK-a-sone/sal-MET-er-all)||
0793|012|B|||
0793|013|C|COMMON BRAND NAME(S): Advair HFA||
0793|014|B|||
0793|015|U|USES:  This product is used to control and prevent symptoms||
0793|016|U|(wheezing and shortness of breath) caused by asthma. It contains||
0793|017|U|2 medications: fluticasone and salmeterol. Fluticasone belongs to||
0793|018|U|a class of drugs known as corticosteroids. It works by reducing||
0793|019|U|the irritation and swelling of the airways. Salmeterol belongs to||
0793|020|U|the class of drugs known as long-acting beta agonists. It works||
0793|021|U|by relaxing the muscles around the airways so that they open up||
0793|022|U|and you can breathe more easily. Controlling symptoms of||
0793|023|U|breathing problems can decrease time lost from work or school.||
0793|024|U|   When used alone, long-acting beta agonists (such as||
0793|025|U|salmeterol) may rarely increase the risk of serious (sometimes||
0793|026|U|fatal) asthma-related breathing problems. However, combination||
0793|027|U|inhaled corticosteroid and long-acting beta agonists, such as||
0793|028|U|this product, do not increase the risk of serious asthma-related||
0793|029|U|breathing problems. This product should be used when breathing||
0793|030|U|problems are not well controlled with one asthma-control||
0793|031|U|medication (such as inhaled corticosteroid) or if your asthma||
0793|032|U|symptoms need combination treatment.||
0793|033|U|   Before using this medication, it is important to learn how to||
0793|034|U|use it properly. This medication must be used regularly to be||
0793|035|U|effective. It does not work right away and should not be used to||
0793|036|U|relieve sudden asthma attacks. If an asthma attack occurs, use||
0793|037|U|your quick-relief inhaler (such as albuterol, also called||
0793|038|U|salbutamol in some countries) as prescribed.||
0793|039|B|||
0793|040|V|OTHER USES:  This section contains uses of this drug that are not||
0793|041|V|listed in the approved professional labeling for the drug but||
0793|042|V|that may be prescribed by your health care professional. Use this||
0793|043|V|drug for a condition that is listed in this section only if it||
0793|044|V|has been so prescribed by your health care professional.||
0793|045|V|   This drug may also be used to control symptoms (such as||
0793|046|V|wheezing and shortness of breath) caused by ongoing lung disease||
0793|047|V|(chronic obstructive pulmonary disease-COPD, which includes||
0793|048|V|chronic bronchitis and emphysema).||
0793|049|B|||
0793|050|H|HOW TO USE:  Read the Patient Information Leaflet and||
0793|051|H|Instructions for Use provided by your pharmacist before you start||
0793|052|H|using this medication and each time you get a refill. Follow the||
0793|053|H|illustrated directions for the proper use of this medication. If||
0793|054|H|you have any questions, ask your doctor or pharmacist.||
0793|055|H|   Follow the instructions for priming the inhaler if you are||
0793|056|H|using it for the first time, if you have not used it for a long||
0793|057|H|time (depending on your product, for more than 1 week or 4||
0793|058|H|weeks), or if you dropped the inhaler. When priming the inhaler,||
0793|059|H|make sure to spray away from the face so that you do not get the||
0793|060|H|medication into your eyes.||
0793|061|H|   Shake the inhaler well for 5 seconds before each use. Inhale||
0793|062|H|this medication by mouth as directed by your doctor, usually||
0793|063|H|twice daily (in the morning and evening, 12 hours apart).||
0793|064|H|   If two inhalations/puffs are prescribed, wait about 30 seconds||
0793|065|H|between them. Shake the inhaler well between each puff. If you||
0793|066|H|are using other inhalers at the same time, wait at least 1 minute||
0793|067|H|between using each medication, and use this drug last.||
0793|068|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
0793|069|H|from developing, gargle, rinse your mouth with water and spit out||
0793|070|H|after each use. Do not swallow the rinse water.||
0793|071|H|   Clean the inhaler at least once a week as directed.||
0793|072|H|   The dosage is based on your medical condition and response to||
0793|073|H|treatment.||
0793|074|H|   Use this medication regularly in order to get the most benefit||
0793|075|H|from it. This medication works best if used at evenly spaced||
0793|076|H|times. To help you remember, use it at the same times each day.||
0793|077|H|Do not increase your dose, use this medication more often, or||
0793|078|H|stop using it without first consulting your doctor. Also, do not||
0793|079|H|use other long-acting beta agonists while using this medication.||
0793|080|H|   If you have been using a quick-relief inhaler (such as||
0793|081|H|albuterol, also called salbutamol in some countries) on a regular||
0793|082|H|daily schedule (such as 4 times daily), you must stop this||
0793|083|H|schedule and only use the quick-relief inhaler as needed for||
0793|084|H|sudden shortness of breath/asthma attacks. Consult your doctor||
0793|085|H|for details.||
0793|086|H|   If you are regularly taking a different corticosteroid by||
0793|087|H|mouth (such as prednisone), you should not stop taking it unless||
0793|088|H|directed by your doctor. Some conditions (such as asthma,||
0793|089|H|allergies) may become worse when the drug is suddenly stopped. If||
0793|090|H|you suddenly stop taking the drug, you may also have withdrawal||
0793|091|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
0793|092|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
0793|093|H|doctor may slowly lower the dose of your old medication after you||
0793|094|H|begin using fluticasone/salmeterol. Tell your doctor or||
0793|095|H|pharmacist right away if you have withdrawal. See also||
0793|096|H|Precautions section.||
0793|097|H|   It may take 1 week or longer before you get the full benefit||
0793|098|H|of this drug. Tell your doctor if your symptoms do not get better||
0793|099|H|or if they get worse.||
0793|100|H|   Learn which of your inhalers you should use every day||
0793|101|H|(controller drugs) and which you should use if your breathing||
0793|102|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
0793|103|H|time what you should do if you have new or worsening cough or||
0793|104|H|shortness of breath, wheezing, increased sputum, worsening peak||
0793|105|H|flow meter readings, waking up at night with trouble breathing,||
0793|106|H|if you use your quick-relief inhaler more often (more than 2 days||
0793|107|H|a week), or if your quick-relief inhaler does not seem to be||
0793|108|H|working well. Learn when you can treat sudden breathing problems||
0793|109|H|by yourself and when you must get medical help right away.||
0793|110|B|||
0793|111|S|SIDE EFFECTS:  Hoarseness, throat irritation, headache, or||
0793|112|S|stomach upset may occur. If any of these effects last or get||
0793|113|S|worse, tell your doctor promptly.||
0793|114|S|   Remember that this medication has been prescribed because your||
0793|115|S|doctor has judged that the benefit to you is greater than the||
0793|116|S|risk of side effects. Many people using this medication do not||
0793|117|S|have serious side effects.||
0793|118|S|   This medication may raise your blood pressure. Check your||
0793|119|S|blood pressure regularly and tell your doctor if the results are||
0793|120|S|high.||
0793|121|S|   Rarely, this medication may cause severe sudden worsening of||
0793|122|S|breathing problems/asthma immediately after use. If you have||
0793|123|S|sudden worsening of breathing, use your quick-relief inhaler and||
0793|124|S|get medical help right away.||
0793|125|S|   Tell your doctor right away if you have any serious side||
0793|126|S|effects, including: white patches on tongue/in mouth, signs of||
0793|127|S|infection (such as sore throat that doesn't go away, fever,||
0793|128|S|chills), mental/mood changes (such as nervousness), trouble||
0793|129|S|sleeping, vision problems (such as blurred vision), increased||
0793|130|S|thirst/urination, muscle cramps, shaking (tremors).||
0793|131|S|   Get medical help right away if you have any very serious side||
0793|132|S|effects, including: chest pain, fast/irregular heartbeat, severe||
0793|133|S|dizziness, fainting, seizures.||
0793|134|S|   A very serious allergic reaction to this product is rare.||
0793|135|S|However, get medical help right away if you notice any symptoms||
0793|136|S|of a serious allergic reaction, including: rash, itching/swelling||
0793|137|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0793|138|S|breathing.||
0793|139|S|   This is not a complete list of possible side effects. If you||
0793|140|S|notice other effects not listed above, contact your doctor or||
0793|141|S|pharmacist.||
0793|142|S|   In the US -||
0793|143|S|   Call your doctor for medical advice about side effects. You||
0793|144|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0793|145|S|www.fda.gov/medwatch.||
0793|146|S|   In Canada - Call your doctor for medical advice about side||
0793|147|S|effects. You may report side effects to Health Canada at||
0793|148|S|1-866-234-2345.||
0793|149|B|||
0793|150|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0793|151|P|pharmacist if you are allergic to fluticasone or salmeterol; or||
0793|152|P|if you have any other allergies. This product may contain||
0793|153|P|inactive ingredients, which can cause allergic reactions or other||
0793|154|P|problems. Talk to your pharmacist for more details.||
0793|155|P|   Before using this medication, tell your doctor or pharmacist||
0793|156|P|your medical history, especially of: current/past infections||
0793|157|P|(such as tuberculosis, herpes), high blood pressure, bone loss||
0793|158|P|(osteoporosis), heart disease (such as chest pain, heart attack,||
0793|159|P|irregular heartbeat), overactive thyroid (hyperthyroidism),||
0793|160|P|diabetes, eye problems (such as cataracts, glaucoma), seizures,||
0793|161|P|liver disease.||
0793|162|P|   Salmeterol may cause a condition that affects the heart rhythm||
0793|163|P|(QT prolongation). QT prolongation can rarely cause serious||
0793|164|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0793|165|P|as severe dizziness, fainting) that need medical attention right||
0793|166|P|away.||
0793|167|P|   The risk of QT prolongation may be increased if you have||
0793|168|P|certain medical conditions or are taking other drugs that may||
0793|169|P|cause QT prolongation. Before using this product, tell your||
0793|170|P|doctor or pharmacist of all the drugs you take and if you have||
0793|171|P|any of the following conditions: certain heart problems (heart||
0793|172|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0793|173|P|history of certain heart problems (QT prolongation in the EKG,||
0793|174|P|sudden cardiac death).||
0793|175|P|   Low levels of potassium or magnesium in the blood may also||
0793|176|P|increase your risk of QT prolongation. This risk may increase if||
0793|177|P|you use certain drugs (such as diuretics/"water pills") or if you||
0793|178|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0793|179|P|Talk to your doctor about using this medication safely.||
0793|180|P|   This medication may mask signs of infection. It can make you||
0793|181|P|more likely to get infections or may make current infections||
0793|182|P|worse. Stay away from anyone who has an infection that may easily||
0793|183|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0793|184|P|doctor if you have been exposed to an infection or for more||
0793|185|P|details.||
0793|186|P|   If you have switched from a corticosteroid taken by mouth||
0793|187|P|(such as prednisone tablets) to this inhaler within the past 12||
0793|188|P|months, or if you have been using this product in||
0793|189|P|higher-than-usual doses for a long time, it may be more difficult||
0793|190|P|for your body to respond to physical stress. Before having||
0793|191|P|surgery or emergency treatment, or if you get a serious||
0793|192|P|illness/injury, tell your doctor or dentist that you are using||
0793|193|P|this medication or have used a corticosteroid taken by mouth||
0793|194|P|within the past 12 months. Tell your doctor right away if you||
0793|195|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
0793|196|P|card or medical ID bracelet that says you use (or have used)||
0793|197|P|corticosteroid medications.||
0793|198|P|   Before having surgery, tell your doctor or dentist about all||
0793|199|P|the products you use (including prescription drugs,||
0793|200|P|nonprescription drugs, and herbal products).||
0793|201|P|   Older adults with COPD may be at greater risk for pneumonia||
0793|202|P|while using this drug. Older adults may also be more sensitive to||
0793|203|P|the side effects of this drug, especially QT prolongation (see||
0793|204|P|above).||
0793|205|P|   This medication may temporarily slow down a child's growth if||
0793|206|P|used for a long time. However, poorly controlled asthma can also||
0793|207|P|slow down growth. See the doctor regularly so your child's height||
0793|208|P|can be checked.||
0793|209|P|   During pregnancy, this medication should be used only when||
0793|210|P|clearly needed. Discuss the risks and benefits with your doctor.||
0793|211|P|   It is unknown if this medication passes into breast milk.||
0793|212|P|Consult your doctor before breastfeeding.||
0793|213|B|||
0793|214|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0793|215|I|medications work or increase your risk for serious side effects.||
0793|216|I|This document does not contain all possible drug interactions.||
0793|217|I|Keep a list of all the products you use (including||
0793|218|I|prescription/nonprescription drugs and herbal products) and share||
0793|219|I|it with your doctor and pharmacist. Do not start, stop, or change||
0793|220|I|the dosage of any medicines without your doctor's approval.||
0793|221|I|   Some products that may interact with this drug include:||
0793|222|I|aldesleukin, desmopressin.||
0793|223|I|   Other medications can affect the removal of fluticasone and||
0793|224|I|salmeterol from your body, which may affect how this product||
0793|225|I|works. Examples include azole antifungals (such as ketoconazole),||
0793|226|I|cobicistat, macrolide antibiotics (such as clarithromycin), HIV||
0793|227|I|protease inhibitors (such as lopinavir), nefazodone, ritonavir,||
0793|228|I|telithromycin, among others.||
0793|229|B|||
0793|230|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0793|231|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0793|232|O|poison control center right away. US residents can call||
0793|233|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0793|234|O|Symptoms of overdose may include: shaking (tremors), chest pain,||
0793|235|O|fast/irregular heartbeat, seizures.||
0793|236|B|||
0793|237|N|NOTES:  Do not share this medication with others.||
0793|238|N|   Lab and/or medical tests (such as lung function, blood||
0793|239|N|pressure, bone density tests, eye exams) may be done while you||
0793|240|N|are using this medication. Keep all medical and lab appointments.||
0793|241|N|Consult your doctor for more details.||
0793|242|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
0793|243|N|mold that can worsen breathing problems. Because the flu virus||
0793|244|N|can also worsen breathing problems, ask your doctor or pharmacist||
0793|245|N|if you should have a flu shot every year.||
0793|246|N|   This medication may cause bone loss (osteoporosis) in adults||
0793|247|N|when used for a long time. Lifestyle changes that may help reduce||
0793|248|N|the risk of bone problems include doing weight-bearing exercise,||
0793|249|N|stopping smoking, limiting alcohol, and getting enough calcium||
0793|250|N|and vitamin D. Talk to your doctor for more details.||
0793|251|B|||
0793|252|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
0793|253|D|next dose at the regular time. Do not double the dose to catch||
0793|254|D|up.||
0793|255|B|||
0793|256|R|STORAGE:  Store at room temperature away from light and heat.||
0793|257|R|Store the inhaler with the mouthpiece down. Do not puncture the||
0793|258|R|canister or use near an open flame. Keep all medications away||
0793|259|R|from children and pets.||
0793|260|R|   Do not flush medications down the toilet or pour them into a||
0793|261|R|drain unless instructed to do so. Properly discard this product||
0793|262|R|when it is expired or no longer needed. Consult your pharmacist||
0793|263|R|or local waste disposal company.||
0793|264|B|||
0793|265|M|MEDICAL ALERT:  Your condition can cause complications in a||
0793|266|M|medical emergency. For information about enrolling in MedicAlert,||
0793|267|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0793|268|B|||
0793|269|A|Information last revised September 2025.||
0793|270|A|Copyright(c) 2025 First Databank, Inc.||
0793|271|B|||
0794|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0794|002|Z|does NOT have all possible information about this product. This||
0794|003|Z|information does not assure that this product is safe, effective,||
0794|004|Z|or appropriate for you. This information is not individual||
0794|005|Z|medical advice and does not substitute for the advice of your||
0794|006|Z|health care professional. Always ask your health care||
0794|007|Z|professional for complete information about this product and your||
0794|008|Z|specific health needs.||
0794|009|B|||
0794|010|T|ABATACEPT - INJECTION||
0794|011|F|(a-BAT-a-sept)||
0794|012|B|||
0794|013|C|COMMON BRAND NAME(S): Orencia||
0794|014|B|||
0794|015|U|USES:  This medication is used to treat rheumatoid arthritis, a||
0794|016|U|condition in which the body's own defense system (immune system)||
0794|017|U|attacks healthy tissue. This leads to swelling in the joints,||
0794|018|U|which causes pain and makes it harder to move. This medication is||
0794|019|U|also used to treat other types of arthritis (such as juvenile||
0794|020|U|idiopathic arthritis, psoriatic arthritis). Abatacept can also be||
0794|021|U|used to prevent a certain problem that can occur after stem cell||
0794|022|U|transplant (acute graft versus host disease).||
0794|023|U|   Abatacept works by weakening your immune system. For patients||
0794|024|U|with arthritis, this effect helps to slow down joint damage and||
0794|025|U|reduce joint pain and swelling so that they can move better.||
0794|026|B|||
0794|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0794|028|H|from your pharmacist before you start using abatacept and each||
0794|029|H|time you get a refill. If you have any questions, ask your doctor||
0794|030|H|or pharmacist.||
0794|031|H|   For the treatment of arthritis, this medication is given by||
0794|032|H|injection into a vein as directed by your doctor, usually over 30||
0794|033|H|minutes. It is usually given every 2 weeks for the first 3 doses,||
0794|034|H|then every 4 weeks.||
0794|035|H|   For the prevention of graft versus host disease, this||
0794|036|H|medication is given by injection into a vein as directed by your||
0794|037|H|doctor, usually over 60 minutes. The first dose of the medication||
0794|038|H|is usually given the day before transplantation and then the||
0794|039|H|medication is given on days 5, 14, and 28 after transplantation.||
0794|040|H|Take all other medications (such as medications to prevent||
0794|041|H|infection) prescribed by your doctor exactly as directed.||
0794|042|H|   The dosage is based on your medical condition and weight.||
0794|043|H|   Infusion reactions may happen during the infusion of this drug||
0794|044|H|and for a short time afterward. Tell your doctor right away if||
0794|045|H|you have any symptoms of infusion reactions such as shortness of||
0794|046|H|breath, dizziness, or headache.||
0794|047|H|   Use this medication regularly to get the most benefit from it.||
0794|048|H|To help you remember, mark your calendar with a reminder.||
0794|049|H|   Tell your doctor if your symptoms do not get better or if they||
0794|050|H|get worse.||
0794|051|B|||
0794|052|S|SIDE EFFECTS:  See also How to Use section.||
0794|053|S|   Headache, nausea, or cold symptoms such as stuffy head/nose||
0794|054|S|may occur. If any of these effects last or get worse, tell your||
0794|055|S|doctor or pharmacist promptly.||
0794|056|S|   Remember that this medication has been prescribed because your||
0794|057|S|doctor has judged that the benefit to you is greater than the||
0794|058|S|risk of side effects. Many people using this medication do not||
0794|059|S|have serious side effects.||
0794|060|S|   Because abatacept works by weakening the immune system, it may||
0794|061|S|lower your ability to fight infections. This may make you more||
0794|062|S|likely to get a serious (rarely fatal) infection or make any||
0794|063|S|infection you have worse. Tell your doctor right away if you have||
0794|064|S|any signs of infection (such as sore throat that doesn't go away,||
0794|065|S|fever, chills).||
0794|066|S|   Rarely, patients using abatacept have developed cancer (such||
0794|067|S|as lymphoma, lung/skin cancer). Tell your doctor right away if||
0794|068|S|you develop symptoms such as unusual lumps/growths/skin changes,||
0794|069|S|swollen lymph nodes, night sweats, unexplained weight loss,||
0794|070|S|shortness of breath, wheezing.||
0794|071|S|   A very serious allergic reaction to this drug is rare.||
0794|072|S|However, get medical help right away if you notice any symptoms||
0794|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0794|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0794|075|S|breathing.||
0794|076|S|   This is not a complete list of possible side effects. If you||
0794|077|S|notice other effects not listed above, contact your doctor or||
0794|078|S|pharmacist.||
0794|079|S|   In the US -||
0794|080|S|   Call your doctor for medical advice about side effects. You||
0794|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0794|082|S|www.fda.gov/medwatch.||
0794|083|S|   In Canada - Call your doctor for medical advice about side||
0794|084|S|effects. You may report side effects to Health Canada at||
0794|085|S|1-866-234-2345.||
0794|086|B|||
0794|087|P|PRECAUTIONS:  Before using abatacept, tell your doctor or||
0794|088|P|pharmacist if you are allergic to it; or if you have any other||
0794|089|P|allergies. This product may contain inactive ingredients, which||
0794|090|P|can cause allergic reactions or other problems. Talk to your||
0794|091|P|pharmacist for more details.||
0794|092|P|   Before using this medication, tell your doctor or pharmacist||
0794|093|P|your medical history, especially of: cancer, chronic obstructive||
0794|094|P|pulmonary disease-COPD, current/recent/returning infection (such||
0794|095|P|as tuberculosis, hepatitis), immune system disorder (such as HIV||
0794|096|P|infection, bone marrow disorder), diabetes.||
0794|097|P|   Abatacept can make you more likely to get infections or may||
0794|098|P|make current infections worse. Stay away from anyone who has an||
0794|099|P|infection that may easily spread (such as chickenpox, COVID-19,||
0794|100|P|measles, flu). Talk to your doctor if you have been exposed to an||
0794|101|P|infection or for more details.||
0794|102|P|   Tell your health care professional that you are using||
0794|103|P|abatacept before having any immunizations/vaccinations. Certain||
0794|104|P|types of vaccines (live vaccines) should not be given during or||
0794|105|P|within 3 months after the last dose of this medication. Avoid||
0794|106|P|contact with people who have recently received live vaccines||
0794|107|P|(such as flu vaccine inhaled through the nose).||
0794|108|P|   Children using this medication should have all recommended||
0794|109|P|vaccinations before starting treatment with abatacept. Ask the||
0794|110|P|child's doctor for details.||
0794|111|P|   Some abatacept products are made with maltose. This substance||
0794|112|P|can cause false high blood sugar levels when your blood sugar is||
0794|113|P|normal or even low. If you have diabetes, ask your pharmacist if||
0794|114|P|the product you are using contains maltose and if your blood||
0794|115|P|sugar testing supplies will work with this product. Rarely,||
0794|116|P|serious problems have occurred when too much insulin was given||
0794|117|P|because of false high blood sugar readings or when low blood||
0794|118|P|sugar went untreated.||
0794|119|P|   Before having surgery, tell your doctor or dentist about all||
0794|120|P|the products you use (including prescription drugs,||
0794|121|P|nonprescription drugs, and herbal products).||
0794|122|P|   During pregnancy, this medication should be used only when||
0794|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
0794|124|P|   It is unknown if this medication passes into breast milk.||
0794|125|P|Consult your doctor before breastfeeding.||
0794|126|B|||
0794|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0794|128|I|medications work or increase your risk for serious side effects.||
0794|129|I|This document does not contain all possible drug interactions.||
0794|130|I|Keep a list of all the products you use (including||
0794|131|I|prescription/nonprescription drugs and herbal products) and share||
0794|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
0794|133|I|the dosage of any medicines without your doctor's approval.||
0794|134|I|   Some products that may interact with this drug include:||
0794|135|I|anakinra, rituximab, TNF blocking agents (such as adalimumab,||
0794|136|I|etanercept, infliximab).||
0794|137|I|   This medication may interfere with certain lab tests||
0794|138|I|(including certain blood sugar tests), possibly causing false||
0794|139|I|test results. Make sure lab personnel and all your doctors know||
0794|140|I|you use this drug.||
0794|141|B|||
0794|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0794|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0794|144|O|poison control center right away. US residents can call||
0794|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0794|146|B|||
0794|147|N|NOTES:  Lab and/or medical tests (such as tuberculosis skin test,||
0794|148|N|test for hepatitis B virus, skin exams) should be done before you||
0794|149|N|start taking this medication and while you are taking it. Keep||
0794|150|N|all medical and lab appointments. Consult your doctor for more||
0794|151|N|details.||
0794|152|B|||
0794|153|D|MISSED DOSE:  It is important to get each dose of this medication||
0794|154|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0794|155|D|right away for a new dosing schedule.||
0794|156|B|||
0794|157|R|STORAGE:  Not applicable. This medication is given in a clinic||
0794|158|R|and will not be stored at home.||
0794|159|B|||
0794|160|M|MEDICAL ALERT:  Your condition can cause complications in a||
0794|161|M|medical emergency. For information about enrolling in MedicAlert,||
0794|162|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0794|163|B|||
0794|164|A|Information last revised May 2025.||
0794|165|A|Copyright(c) 2025 First Databank, Inc.||
0794|166|B|||
0795|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0795|002|Z|does NOT have all possible information about this product. This||
0795|003|Z|information does not assure that this product is safe, effective,||
0795|004|Z|or appropriate for you. This information is not individual||
0795|005|Z|medical advice and does not substitute for the advice of your||
0795|006|Z|health care professional. Always ask your health care||
0795|007|Z|professional for complete information about this product and your||
0795|008|Z|specific health needs.||
0795|009|B|||
0795|010|T|LITHIUM CONTROLLED-RELEASE - ORAL||
0795|011|F|(LITH-ee-um)||
0795|012|B|||
0795|013|C|COMMON BRAND NAME(S): Eskalith CR, Lithobid||
0795|014|B|||
0795|015|W|WARNING:  It is very important to have the right amount of||
0795|016|W|lithium in your body. Too much lithium may lead to unwanted||
0795|017|W|effects such as nausea, diarrhea, shaking of the hands,||
0795|018|W|dizziness, twitching, seizures, trouble speaking, confusion, or||
0795|019|W|increase in the amount of urine. Tell your doctor right away if||
0795|020|W|these effects occur.||
0795|021|W|   There is only a small difference between the correct amount of||
0795|022|W|lithium and too much lithium. It is important that your doctor||
0795|023|W|monitor you closely during treatment. Keep all medical and lab||
0795|024|W|appointments while you are taking lithium.||
0795|025|B|||
0795|026|U|USES:  This medication is used to treat manic-depressive disorder||
0795|027|U|(bipolar disorder). It works to stabilize the mood and reduce||
0795|028|U|extremes in behavior by restoring the balance of certain natural||
0795|029|U|substances (neurotransmitters) in the brain.||
0795|030|U|   Some of the benefits of continued use of this medication||
0795|031|U|include decreasing how often manic episodes occur and decreasing||
0795|032|U|the symptoms of manic episodes such as exaggerated feelings of||
0795|033|U|well-being, feelings that others wish to harm you, irritability,||
0795|034|U|anxiousness, rapid/loud speech, and aggressive/hostile behaviors.||
0795|035|B|||
0795|036|V|OTHER USES:  This section contains uses of this drug that are not||
0795|037|V|listed in the approved professional labeling for the drug but||
0795|038|V|that may be prescribed by your health care professional. Use this||
0795|039|V|drug for a condition that is listed in this section only if it||
0795|040|V|has been so prescribed by your health care professional.||
0795|041|V|   This drug may also be used to reduce the risk of a certain||
0795|042|V|type of headache (cluster headache).||
0795|043|B|||
0795|044|H|HOW TO USE:  There are different brands of this medication||
0795|045|H|available. They may not have the same effects. Do not change||
0795|046|H|brands without asking your doctor or pharmacist.||
0795|047|H|   Take this medication by mouth as directed by your doctor,||
0795|048|H|usually 2-3 times daily. Take lithium with or immediately after||
0795|049|H|meals to lessen stomach upset. Do not crush or chew this||
0795|050|H|medication. Doing so can release all of the drug at once,||
0795|051|H|increasing the risk of side effects. Also, do not split the||
0795|052|H|tablets unless they have a score line and your doctor or||
0795|053|H|pharmacist tells you to do so. Swallow the whole or split tablet||
0795|054|H|without crushing or chewing.||
0795|055|H|   Drink 8 to 12 glasses (8 ounces or 240 milliliters each) of||
0795|056|H|water or other fluid each day, and eat a healthy diet with normal||
0795|057|H|amounts of salt (sodium) as directed by your doctor or dietician||
0795|058|H|while taking this medication. Large changes in the amount of salt||
0795|059|H|in your diet may change your lithium blood levels. Do not change||
0795|060|H|the amount of salt in your diet unless your doctor tells you to||
0795|061|H|do so.||
0795|062|H|   Use this medication regularly to get the most benefit from it.||
0795|063|H|To help you remember, take it at the same times each day. The||
0795|064|H|dosage is based on your medical condition, lithium blood levels,||
0795|065|H|and response to treatment. This medication works best if the||
0795|066|H|amount of the drug in your body is kept at a constant level. Take||
0795|067|H|this drug at evenly spaced intervals.||
0795|068|H|   This medication must be taken exactly as prescribed. Keep||
0795|069|H|taking lithium even if you feel well. Do not stop taking this||
0795|070|H|drug without consulting your doctor. Some conditions may become||
0795|071|H|worse when this drug is suddenly stopped. Consult your doctor or||
0795|072|H|pharmacist for more details.||
0795|073|H|   Tell your doctor if your condition does not get better or if||
0795|074|H|it gets worse. It may take 1 to 3 weeks to notice improvement in||
0795|075|H|your condition.||
0795|076|B|||
0795|077|S|SIDE EFFECTS:  See also Warning section.||
0795|078|S|   Drowsiness, dizziness, tiredness, increased thirst, increased||
0795|079|S|frequency of urination, weight gain, and mildly shaking hands||
0795|080|S|(fine tremor) may occur. These should go away as your body||
0795|081|S|adjusts to the medication. If any of these effects last or get||
0795|082|S|worse, tell your doctor or pharmacist promptly.||
0795|083|S|   Remember that this medication has been prescribed because your||
0795|084|S|doctor has judged that the benefit to you is greater than the||
0795|085|S|risk of side effects. Many people using this medication do not||
0795|086|S|have serious side effects.||
0795|087|S|   Tell your doctor right away if you have any serious side||
0795|088|S|effects, including: diarrhea, vomiting, unsteady walk, confusion,||
0795|089|S|trouble speaking, blurred vision, severe hand trembling (coarse||
0795|090|S|tremor), vision changes (such as growing blind spot, vision||
0795|091|S|loss), joint swelling/pain, pain/discoloration of finger/toes,||
0795|092|S|cold hands/feet.||
0795|093|S|   Get medical help right away if you have any very serious side||
0795|094|S|effects, including: severe dizziness, fainting,||
0795|095|S|slow/fast/irregular heartbeat, shortness of breath, seizures.||
0795|096|S|   This medication may increase serotonin and rarely cause a very||
0795|097|S|serious condition called serotonin syndrome/toxicity. The risk||
0795|098|S|increases if you are also taking other drugs that increase||
0795|099|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0795|100|S|take (see Drug Interactions section). Get medical help right away||
0795|101|S|if you develop some of the following symptoms: fast heartbeat,||
0795|102|S|hallucinations, loss of coordination, severe dizziness, severe||
0795|103|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0795|104|S|unusual agitation/restlessness.||
0795|105|S|   A very serious allergic reaction to this drug is rare.||
0795|106|S|However, get medical help right away if you notice any symptoms||
0795|107|S|of a serious allergic reaction, including: swollen lymph nodes,||
0795|108|S|rash, itching/swelling (especially of the face/tongue/throat),||
0795|109|S|severe dizziness, trouble breathing.||
0795|110|S|   This is not a complete list of possible side effects. If you||
0795|111|S|notice other effects not listed above, contact your doctor or||
0795|112|S|pharmacist.||
0795|113|S|   In the US -||
0795|114|S|   Call your doctor for medical advice about side effects. You||
0795|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0795|116|S|www.fda.gov/medwatch.||
0795|117|S|   In Canada - Call your doctor for medical advice about side||
0795|118|S|effects. You may report side effects to Health Canada at||
0795|119|S|1-866-234-2345.||
0795|120|B|||
0795|121|P|PRECAUTIONS:  Before taking lithium, tell your doctor or||
0795|122|P|pharmacist if you are allergic to it; or if you have any other||
0795|123|P|allergies. This product may contain inactive ingredients, which||
0795|124|P|can cause allergic reactions or other problems. Talk to your||
0795|125|P|pharmacist for more details.||
0795|126|P|   Before using this medication, tell your doctor or pharmacist||
0795|127|P|your medical history, especially of: heart disease, kidney||
0795|128|P|disease, urinary problems (such as difficulty urinating),||
0795|129|P|underactive thyroid (hypothyroidism), seizures, Parkinson's||
0795|130|P|disease, leukemia, severe dehydration, any infection with high||
0795|131|P|fever, a certain skin disorder (psoriasis).||
0795|132|P|   Lithium treatment may rarely reveal an existing condition that||
0795|133|P|affects the heart rhythm (Brugada syndrome). Brugada syndrome is||
0795|134|P|an inherited, life-threatening heart problem that some people may||
0795|135|P|have without knowing it. It can cause a serious (possibly fatal)||
0795|136|P|abnormal heartbeat and other symptoms (such as severe dizziness,||
0795|137|P|fainting, shortness of breath) that need medical attention right||
0795|138|P|away. Brugada syndrome may cause death suddenly. Before starting||
0795|139|P|lithium treatment, tell your doctor if you have any of the||
0795|140|P|following risk factors: Brugada syndrome, unexplained fainting,||
0795|141|P|family history of certain heart problems (Brugada syndrome,||
0795|142|P|sudden unexplained death before 45 years old).||
0795|143|P|   This drug may make you dizzy or drowsy or blur your vision.||
0795|144|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0795|145|P|drowsy. Do not drive, use machinery, or do anything that needs||
0795|146|P|alertness or clear vision until you can do it safely. Limit||
0795|147|P|alcoholic beverages. Talk to your doctor if you are using||
0795|148|P|marijuana (cannabis).||
0795|149|P|   If heavy sweating or severe diarrhea occurs, check with your||
0795|150|P|doctor right away how to best keep taking lithium. Take care in||
0795|151|P|hot weather or during activities that cause you to sweat heavily||
0795|152|P|such as during hot baths, saunas, or exercise.||
0795|153|P|   Before having surgery, tell your doctor or dentist about all||
0795|154|P|the products you use (including prescription drugs,||
0795|155|P|nonprescription drugs, and herbal products).||
0795|156|P|   Tell your doctor if you are pregnant or plan to become||
0795|157|P|pregnant. You should not become pregnant while using lithium.||
0795|158|P|Lithium may harm an unborn baby. However, since untreated||
0795|159|P|mental/mood problems (such as bipolar disorder) can harm a||
0795|160|P|pregnant woman and her unborn baby, do not stop taking this||
0795|161|P|medication unless directed by your doctor. Instead, ask your||
0795|162|P|doctor if a different medication would be right for you. If you||
0795|163|P|are planning pregnancy, become pregnant, or think you may be||
0795|164|P|pregnant, talk to your doctor right away about the risks and||
0795|165|P|benefits of this medication.||
0795|166|P|   Lithium passes into breast milk and may have undesirable||
0795|167|P|effects on a nursing infant. Breastfeeding is not recommended||
0795|168|P|while using this medication. Consult your doctor before||
0795|169|P|breastfeeding.||
0795|170|B|||
0795|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0795|172|I|medications work or increase your risk for serious side effects.||
0795|173|I|This document does not contain all possible drug interactions.||
0795|174|I|Keep a list of all the products you use (including||
0795|175|I|prescription/nonprescription drugs and herbal products) and share||
0795|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
0795|177|I|the dosage of any medicines without your doctor's approval.||
0795|178|I|   Other medications can affect the removal of lithium from your||
0795|179|I|body, which may affect how lithium works. Examples include ACE||
0795|180|I|inhibitors (such as captopril, enalapril), ARBs (such as||
0795|181|I|losartan, valsartan), NSAIDs (such as celecoxib, ibuprofen),||
0795|182|I|"water pills" (diuretics such as hydrochlorothiazide,||
0795|183|I|furosemide), other drugs for mental/mood conditions (such as||
0795|184|I|chlorpromazine, haloperidol, thiothixene), among others. Your||
0795|185|I|doctor may need to adjust your dose of lithium if you are on||
0795|186|I|these medications.||
0795|187|I|   The risk of serotonin syndrome/toxicity increases if you are||
0795|188|I|also taking other drugs that increase serotonin. Some examples||
0795|189|I|are street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0795|190|I|antidepressants (such as SSRIs like fluoxetine/paroxetine, SNRIs||
0795|191|I|like duloxetine/venlafaxine), among others. The risk of serotonin||
0795|192|I|syndrome/toxicity may be more likely when you start or increase||
0795|193|I|the dose of these drugs.||
0795|194|I|   Eat a normal diet with an average amount of sodium. Consult||
0795|195|I|your doctor or dietician for more details.||
0795|196|B|||
0795|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0795|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0795|199|O|poison control center right away. US residents can call||
0795|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0795|201|O|Symptoms of overdose may include: diarrhea, vomiting, ringing in||
0795|202|O|the ears, blurred vision, trouble walking, unusual drowsiness,||
0795|203|O|seizures, shaking, loss of consciousness.||
0795|204|B|||
0795|205|N|NOTES:  Do not share this medication with others.||
0795|206|N|   Lab and/or medical tests (such as kidney/thyroid function,||
0795|207|N|lithium and calcium blood levels) should be done before you start||
0795|208|N|taking this medication and while you are taking it. Keep all||
0795|209|N|medical and lab appointments. Consult your doctor for more||
0795|210|N|details.||
0795|211|B|||
0795|212|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0795|213|D|remember. If it is within 6 hours of the next dose, skip the||
0795|214|D|missed dose. Take your next dose at the regular time. Do not||
0795|215|D|double the dose to catch up.||
0795|216|B|||
0795|217|R|STORAGE:  Store at room temperature away from light and moisture.||
0795|218|R|Do not store in the bathroom. Keep all medications away from||
0795|219|R|children and pets.||
0795|220|R|   Do not flush medications down the toilet or pour them into a||
0795|221|R|drain unless instructed to do so. Properly discard this product||
0795|222|R|when it is expired or no longer needed. Consult your pharmacist||
0795|223|R|or local waste disposal company.||
0795|224|B|||
0795|225|A|Information last revised November 2024.||
0795|226|A|Copyright(c) 2025 First Databank, Inc.||
0795|227|B|||
0798|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0798|002|Z|does NOT have all possible information about this product. This||
0798|003|Z|information does not assure that this product is safe, effective,||
0798|004|Z|or appropriate for you. This information is not individual||
0798|005|Z|medical advice and does not substitute for the advice of your||
0798|006|Z|health care professional. Always ask your health care||
0798|007|Z|professional for complete information about this product and your||
0798|008|Z|specific health needs.||
0798|009|B|||
0798|010|T|CEFAZOLIN - INJECTION||
0798|011|F|(sef-A-zoe-lin)||
0798|012|B|||
0798|013|C|COMMON BRAND NAME(S): Ancef||
0798|014|B|||
0798|015|U|USES:  Cefazolin is an antibiotic used to treat a wide variety of||
0798|016|U|bacterial infections. It may also be used before and during||
0798|017|U|certain surgeries to help prevent infection. This medication is||
0798|018|U|known as a cephalosporin antibiotic. It works by stopping the||
0798|019|U|growth of bacteria.||
0798|020|B|||
0798|021|H|HOW TO USE:  Depending on your specific product, this medication||
0798|022|H|is given by injection into a vein or into a muscle. Use this||
0798|023|H|product exactly as directed by your doctor. The dosage is based||
0798|024|H|on your medical condition and response to treatment. Children's||
0798|025|H|dosage is also based on weight.||
0798|026|H|   If you are giving this medication to yourself at home, learn||
0798|027|H|all preparation and usage instructions from your health care||
0798|028|H|professional. Before using, check this product for particles or||
0798|029|H|discoloration. If either is present, do not use the liquid. Learn||
0798|030|H|how to store and discard medical supplies safely.||
0798|031|H|   For the best effect, use this antibiotic at evenly spaced||
0798|032|H|times. To help you remember, use this medication at the same||
0798|033|H|time(s) every day.||
0798|034|H|   Continue to use this medication until the full prescribed||
0798|035|H|treatment period is finished, even if symptoms disappear after a||
0798|036|H|few days. Stopping the medication too early may result in a||
0798|037|H|return of the infection.||
0798|038|H|   Tell your doctor if your condition lasts or gets worse.||
0798|039|B|||
0798|040|S|SIDE EFFECTS:  Swelling, redness, pain, or soreness at the||
0798|041|S|injection site may occur. This medication may also rarely cause||
0798|042|S|loss of appetite, nausea, vomiting, diarrhea, or headache. If any||
0798|043|S|of these effects last or get worse, tell your doctor or||
0798|044|S|pharmacist promptly.||
0798|045|S|   Remember that this medication has been prescribed because your||
0798|046|S|doctor has judged that the benefit to you is greater than the||
0798|047|S|risk of side effects. Many people using this medication do not||
0798|048|S|have serious side effects.||
0798|049|S|   Tell your doctor right away if you have any serious side||
0798|050|S|effects, including: dark urine, easy bruising/bleeding,||
0798|051|S|fast/pounding/irregular heartbeat, seizures, unusual weakness,||
0798|052|S|yellowing eyes/skin, mental/mood changes (such as confusion).||
0798|053|S|   This medication may rarely cause a severe intestinal condition||
0798|054|S|due to a bacteria called C. difficile. This condition may occur||
0798|055|S|during treatment or weeks to months after treatment has stopped.||
0798|056|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0798|057|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0798|058|S|stool.||
0798|059|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0798|060|S|products because they may make symptoms worse.||
0798|061|S|   Use of this medication for prolonged or repeated periods may||
0798|062|S|result in oral thrush or a new vaginal yeast infection. Contact||
0798|063|S|your doctor if you notice white patches in your mouth, a change||
0798|064|S|in vaginal discharge, or other new symptoms.||
0798|065|S|   A very serious allergic reaction to this drug is rare.||
0798|066|S|However, get medical help right away if you notice any symptoms||
0798|067|S|of a serious allergic reaction, including: rash, itching/swelling||
0798|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0798|069|S|breathing.||
0798|070|S|   This is not a complete list of possible side effects. If you||
0798|071|S|notice other effects not listed above, contact your doctor or||
0798|072|S|pharmacist.||
0798|073|S|   In the US -||
0798|074|S|   Call your doctor for medical advice about side effects. You||
0798|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0798|076|S|www.fda.gov/medwatch.||
0798|077|S|   In Canada - Call your doctor for medical advice about side||
0798|078|S|effects. You may report side effects to Health Canada at||
0798|079|S|1-866-234-2345.||
0798|080|B|||
0798|081|P|PRECAUTIONS:  Before using cefazolin, tell your doctor or||
0798|082|P|pharmacist if you are allergic to it; or to other cephalosporins;||
0798|083|P|or to penicillins; or if you have any other allergies. This||
0798|084|P|product may contain inactive ingredients, which can cause||
0798|085|P|allergic reactions or other problems. Talk to your pharmacist for||
0798|086|P|more details.||
0798|087|P|   Before using this medication, tell your doctor or pharmacist||
0798|088|P|your medical history, especially of: kidney disease, liver||
0798|089|P|disease, stomach/intestinal diseases (such as colitis).||
0798|090|P|   Cefazolin may cause live bacterial vaccines (such as typhoid||
0798|091|P|vaccine) to not work well. Tell your health care professional||
0798|092|P|that you are using cefazolin before having any||
0798|093|P|immunizations/vaccinations.||
0798|094|P|   Before having surgery, tell your doctor or dentist about all||
0798|095|P|the products you use (including prescription drugs,||
0798|096|P|nonprescription drugs, and herbal products).||
0798|097|P|   Tell your doctor if you are pregnant before using this||
0798|098|P|medication.||
0798|099|P|   This medication passes into breast milk. Consult your doctor||
0798|100|P|before breastfeeding.||
0798|101|B|||
0798|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0798|103|I|medications work or increase your risk for serious side effects.||
0798|104|I|This document does not contain all possible drug interactions.||
0798|105|I|Keep a list of all the products you use (including||
0798|106|I|prescription/nonprescription drugs and herbal products) and share||
0798|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
0798|108|I|the dosage of any medicines without your doctor's approval.||
0798|109|I|   This medication may interfere with certain lab tests||
0798|110|I|(including Coombs' test, certain urine glucose tests), possibly||
0798|111|I|causing false test results. Make sure lab personnel and all your||
0798|112|I|doctors know you use this drug.||
0798|113|B|||
0798|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0798|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0798|116|O|poison control center right away. US residents can call||
0798|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0798|118|O|Symptoms of overdose may include: trouble breathing, seizures.||
0798|119|B|||
0798|120|N|NOTES:  Lab and/or medical tests (such as complete blood count or||
0798|121|N|kidney function) may be done while you are using this product.||
0798|122|N|Keep all medical and lab appointments. Consult your doctor for||
0798|123|N|more details.||
0798|124|B|||
0798|125|D|MISSED DOSE:  It is important to get each dose of this medication||
0798|126|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0798|127|D|right away for a new dosing schedule. Do not double the dose to||
0798|128|D|catch up.||
0798|129|B|||
0798|130|R|STORAGE:  Consult the product instructions and your pharmacist||
0798|131|R|for storage details. Keep all medications away from children and||
0798|132|R|pets.||
0798|133|R|   Do not flush medications down the toilet or pour them into a||
0798|134|R|drain unless instructed to do so. Properly discard this product||
0798|135|R|when it is expired or no longer needed. Consult your pharmacist||
0798|136|R|or local waste disposal company.||
0798|137|B|||
0798|138|A|Information last revised December 2024.||
0798|139|A|Copyright(c) 2025 First Databank, Inc.||
0798|140|B|||
0799|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0799|002|Z|does NOT have all possible information about this product. This||
0799|003|Z|information does not assure that this product is safe, effective,||
0799|004|Z|or appropriate for you. This information is not individual||
0799|005|Z|medical advice and does not substitute for the advice of your||
0799|006|Z|health care professional. Always ask your health care||
0799|007|Z|professional for complete information about this product and your||
0799|008|Z|specific health needs.||
0799|009|B|||
0799|010|T|CEFOXITIN - INJECTION||
0799|011|F|(sef-OX-i-tin)||
0799|012|B|||
0799|013|C|COMMON BRAND NAME(S): Mefoxin||
0799|014|B|||
0799|015|U|USES:  Cefoxitin is an antibiotic used to treat a wide variety of||
0799|016|U|bacterial infections. It may also be used before and during||
0799|017|U|certain surgeries to help prevent infection. This medication is||
0799|018|U|known as a cephalosporin antibiotic. It works by stopping the||
0799|019|U|growth of bacteria.||
0799|020|B|||
0799|021|H|HOW TO USE:  This medication is given by injection into a muscle||
0799|022|H|or vein as directed by your doctor. The dosage is based on your||
0799|023|H|medical condition and response to treatment.||
0799|024|H|   If you are giving this medication to yourself at home, learn||
0799|025|H|all preparation and usage instructions from your health care||
0799|026|H|professional. Before using, check this product for particles or||
0799|027|H|discoloration. If either is present, do not use the liquid. Learn||
0799|028|H|how to store and discard medical supplies safely.||
0799|029|H|   For the best effect, use this antibiotic at evenly spaced||
0799|030|H|times. To help you remember, use this medication at the same||
0799|031|H|time(s) every day.||
0799|032|H|   Continue to use this medication until the full prescribed||
0799|033|H|treatment period is finished, even if symptoms disappear after a||
0799|034|H|few days. Stopping the medication too early may result in a||
0799|035|H|return of the infection.||
0799|036|H|   Tell your doctor if your condition lasts or gets worse.||
0799|037|B|||
0799|038|S|SIDE EFFECTS:  Swelling, redness, pain, or soreness at the||
0799|039|S|injection site may occur. This medication may also rarely cause||
0799|040|S|loss of appetite, nausea, vomiting, diarrhea, or headache. If any||
0799|041|S|of these effects last or get worse, tell your doctor or||
0799|042|S|pharmacist promptly.||
0799|043|S|   Remember that this medication has been prescribed because your||
0799|044|S|doctor has judged that the benefit to you is greater than the||
0799|045|S|risk of side effects. Many people using this medication do not||
0799|046|S|have serious side effects.||
0799|047|S|   Tell your doctor right away if you have any serious side||
0799|048|S|effects, including: dark urine, easy bruising/bleeding,||
0799|049|S|fast/pounding/irregular heartbeat, seizures, unusual weakness,||
0799|050|S|yellowing eyes/skin, mental/mood changes (such as confusion).||
0799|051|S|   This medication may rarely cause a severe intestinal condition||
0799|052|S|due to a bacteria called C. difficile. This condition may occur||
0799|053|S|during treatment or weeks to months after treatment has stopped.||
0799|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0799|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0799|056|S|stool.||
0799|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0799|058|S|products because they may make symptoms worse.||
0799|059|S|   Use of this medication for prolonged or repeated periods may||
0799|060|S|result in oral thrush or a new vaginal yeast infection. Contact||
0799|061|S|your doctor if you notice white patches in your mouth, a change||
0799|062|S|in vaginal discharge, or other new symptoms.||
0799|063|S|   A very serious allergic reaction to this drug is rare.||
0799|064|S|However, get medical help right away if you notice any symptoms||
0799|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0799|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0799|067|S|breathing.||
0799|068|S|   This is not a complete list of possible side effects. If you||
0799|069|S|notice other effects not listed above, contact your doctor or||
0799|070|S|pharmacist.||
0799|071|S|   In the US -||
0799|072|S|   Call your doctor for medical advice about side effects. You||
0799|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0799|074|S|www.fda.gov/medwatch.||
0799|075|S|   In Canada - Call your doctor for medical advice about side||
0799|076|S|effects. You may report side effects to Health Canada at||
0799|077|S|1-866-234-2345.||
0799|078|B|||
0799|079|P|PRECAUTIONS:  Before using cefoxitin, tell your doctor or||
0799|080|P|pharmacist if you are allergic to it; or to other cephalosporins;||
0799|081|P|or to penicillins; or if you have any other allergies. This||
0799|082|P|product may contain inactive ingredients, which can cause||
0799|083|P|allergic reactions or other problems. Talk to your pharmacist for||
0799|084|P|more details.||
0799|085|P|   Before using this medication, tell your doctor or pharmacist||
0799|086|P|your medical history, especially of: kidney disease, liver||
0799|087|P|disease, stomach/intestinal diseases (such as colitis).||
0799|088|P|   Cefoxitin may cause live bacterial vaccines (such as typhoid||
0799|089|P|vaccine) to not work well. Tell your health care professional||
0799|090|P|that you are using cefoxitin before having any||
0799|091|P|immunizations/vaccinations.||
0799|092|P|   Before having surgery, tell your doctor or dentist about all||
0799|093|P|the products you use (including prescription drugs,||
0799|094|P|nonprescription drugs, and herbal products).||
0799|095|P|   Tell your doctor if you are pregnant before using this||
0799|096|P|medication.||
0799|097|P|   This medication passes into breast milk. Consult your doctor||
0799|098|P|before breastfeeding.||
0799|099|B|||
0799|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0799|101|I|medications work or increase your risk for serious side effects.||
0799|102|I|This document does not contain all possible drug interactions.||
0799|103|I|Keep a list of all the products you use (including||
0799|104|I|prescription/nonprescription drugs and herbal products) and share||
0799|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
0799|106|I|the dosage of any medicines without your doctor's approval.||
0799|107|I|   This medication may interfere with certain lab tests (such as||
0799|108|I|Coombs' test, urine glucose tests, serum or urine creatinine||
0799|109|I|tests), possibly causing false test results. Make sure lab||
0799|110|I|personnel and all your doctors know you use this drug.||
0799|111|B|||
0799|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0799|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0799|114|O|poison control center right away. US residents can call||
0799|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0799|116|O|Symptoms of overdose may include: trouble breathing, seizures.||
0799|117|B|||
0799|118|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0799|119|N|kidney function) may be done while you are using this product.||
0799|120|N|Keep all medical and lab appointments. Consult your doctor for||
0799|121|N|more details.||
0799|122|B|||
0799|123|D|MISSED DOSE:  It is important to get each dose of this medication||
0799|124|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0799|125|D|right away for a new dosing schedule. Do not double the dose to||
0799|126|D|catch up.||
0799|127|B|||
0799|128|R|STORAGE:  Consult the product instructions and your pharmacist||
0799|129|R|for storage details. Keep all medications away from children and||
0799|130|R|pets.||
0799|131|R|   Do not flush medications down the toilet or pour them into a||
0799|132|R|drain unless instructed to do so. Properly discard this product||
0799|133|R|when it is expired or no longer needed. Consult your pharmacist||
0799|134|R|or local waste disposal company.||
0799|135|B|||
0799|136|A|Information last revised December 2024.||
0799|137|A|Copyright(c) 2025 First Databank, Inc.||
0799|138|B|||
0800|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0800|002|Z|does NOT have all possible information about this product. This||
0800|003|Z|information does not assure that this product is safe, effective,||
0800|004|Z|or appropriate for you. This information is not individual||
0800|005|Z|medical advice and does not substitute for the advice of your||
0800|006|Z|health care professional. Always ask your health care||
0800|007|Z|professional for complete information about this product and your||
0800|008|Z|specific health needs.||
0800|009|B|||
0800|010|T|TERBUTALINE - SUBCUTANEOUS INJECTION||
0800|011|F|(ter-BYOO-ta-leen)||
0800|012|B|||
0800|013|C|COMMON BRAND NAME(S): Brethine||
0800|014|B|||
0800|015|W|WARNING:  Terbutaline should not be used for more than 2-3 days||
0800|016|W|when treating early labor. Using terbutaline for prevention or||
0800|017|W|prolonged treatment (greater than 2-3 days) of early labor has||
0800|018|W|risks to the mother that are greater than any possible benefits.||
0800|019|W|Serious (sometimes fatal) side effects have rarely occurred in||
0800|020|W|mothers using terbutaline during labor, such as chest pain,||
0800|021|W|fast/irregular heartbeats, and trouble breathing. Tell your||
0800|022|W|doctor right away should any of these side effects occur. If you||
0800|023|W|are pregnant or become pregnant and are using terbutaline for||
0800|024|W|another medical condition (such as asthma), talk to your doctor||
0800|025|W|or pharmacist about whether terbutaline is still right for you.||
0800|026|B|||
0800|027|U|USES:  Terbutaline is used to treat wheezing and shortness of||
0800|028|U|breath from lung problems (such as asthma, chronic obstructive||
0800|029|U|pulmonary disease-COPD, bronchitis, emphysema). Terbutaline||
0800|030|U|belongs to a class of drugs known as bronchodilators. It works by||
0800|031|U|relaxing the muscles around the airways so that they open up and||
0800|032|U|you can breathe more easily.||
0800|033|B|||
0800|034|V|OTHER USES:  This section contains uses of this drug that are not||
0800|035|V|listed in the approved professional labeling for the drug but||
0800|036|V|that may be prescribed by your health care professional. Use this||
0800|037|V|drug for a condition that is listed in this section only if it||
0800|038|V|has been so prescribed by your health care professional.||
0800|039|V|   This medication is also used in pregnant women for no more||
0800|040|V|than 2-3 days to stop early labor. See Warning Section.||
0800|041|B|||
0800|042|H|HOW TO USE:  This medication is given by injection under the skin||
0800|043|H|as directed by your doctor. The injection is given in the||
0800|044|H|shoulder/upper arm area. The dosage is based on your medical||
0800|045|H|condition and response to treatment. Do not use more than 0.5||
0800|046|H|milligrams of this medication over a 4-hour period.||
0800|047|H|   If you are giving this medication to yourself at home, learn||
0800|048|H|all preparation and usage instructions from your health care||
0800|049|H|professional. Before using, check this product for particles or||
0800|050|H|discoloration. If either is present, do not use the liquid. Learn||
0800|051|H|how to store and discard medical supplies safely.||
0800|052|H|   If you take other asthma drugs by mouth or with inhaling||
0800|053|H|devices, ask your doctor about how to correctly use this||
0800|054|H|medication with your other asthma medicines.||
0800|055|H|   Tell your doctor if your condition lasts or gets worse.||
0800|056|B|||
0800|057|S|SIDE EFFECTS:  Nervousness, shaking (tremor), dizziness,||
0800|058|S|drowsiness, headache, or pain at injection site may occur. If any||
0800|059|S|of these effects last or get worse, tell your doctor or||
0800|060|S|pharmacist promptly.||
0800|061|S|   Remember that this medication has been prescribed because your||
0800|062|S|doctor has judged that the benefit to you is greater than the||
0800|063|S|risk of side effects. Many people using this medication do not||
0800|064|S|have serious side effects.||
0800|065|S|   This medication may raise your blood pressure. Check your||
0800|066|S|blood pressure regularly and tell your doctor if the results are||
0800|067|S|high.||
0800|068|S|   Tell your doctor right away if you have any serious side||
0800|069|S|effects, including: fast/pounding/irregular heartbeat, muscle||
0800|070|S|cramps, weakness, seizures.||
0800|071|S|   Get medical help right away if you have any very serious side||
0800|072|S|effects, including: chest pain, rapid breathing, confusion.||
0800|073|S|   A very serious allergic reaction to this drug is rare.||
0800|074|S|However, get medical help right away if you notice any symptoms||
0800|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0800|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0800|077|S|breathing.||
0800|078|S|   This is not a complete list of possible side effects. If you||
0800|079|S|notice other effects not listed above, contact your doctor or||
0800|080|S|pharmacist. See Warning Section.||
0800|081|S|   In the US -||
0800|082|S|   Call your doctor for medical advice about side effects. You||
0800|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0800|084|S|www.fda.gov/medwatch.||
0800|085|S|   In Canada - Call your doctor for medical advice about side||
0800|086|S|effects. You may report side effects to Health Canada at||
0800|087|S|1-866-234-2345.||
0800|088|B|||
0800|089|P|PRECAUTIONS:  Before using terbutaline, tell your doctor or||
0800|090|P|pharmacist if you are allergic to it; or to similar||
0800|091|P|bronchodilators (such as albuterol, metaproterenol); or to||
0800|092|P|sympathomimetic drugs (such as epinephrine, pseudoephedrine); or||
0800|093|P|if you have any other allergies. This product may contain||
0800|094|P|inactive ingredients, which can cause allergic reactions or other||
0800|095|P|problems. Talk to your pharmacist for more details.||
0800|096|P|   Before using this medication, tell your doctor or pharmacist||
0800|097|P|your medical history, especially of: heart disease (such as||
0800|098|P|irregular heartbeat, coronary artery disease), high blood||
0800|099|P|pressure, seizures, overactive thyroid (hyperthyroidism),||
0800|100|P|diabetes, low blood potassium level (hypokalemia).||
0800|101|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0800|102|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0800|103|P|machinery, or do anything that needs alertness until you can do||
0800|104|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0800|105|P|are using marijuana (cannabis).||
0800|106|P|   Before having surgery, tell your doctor or dentist about all||
0800|107|P|the products you use (including prescription drugs,||
0800|108|P|nonprescription drugs, and herbal products).||
0800|109|P|   Older adults may be more sensitive to the side effects of this||
0800|110|P|drug, especially the effects on the heart.||
0800|111|P|   During pregnancy, this medication should be used only when||
0800|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
0800|113|P|See Warning Section.||
0800|114|P|   Terbutaline passes into breast milk. Consult your doctor||
0800|115|P|before breastfeeding.||
0800|116|B|||
0800|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0800|118|I|medications work or increase your risk for serious side effects.||
0800|119|I|This document does not contain all possible drug interactions.||
0800|120|I|Keep a list of all the products you use (including||
0800|121|I|prescription/nonprescription drugs and herbal products) and share||
0800|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
0800|123|I|the dosage of any medicines without your doctor's approval.||
0800|124|B|||
0800|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0800|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0800|127|O|poison control center right away. US residents can call||
0800|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0800|129|O|Symptoms of overdose may include: severe headache, severe||
0800|130|O|dizziness, seizures, fast/irregular heartbeat, chest pain.||
0800|131|B|||
0800|132|N|NOTES:  Do not share this medication with others.||
0800|133|N|   Lab and/or medical tests (such as potassium levels, heart||
0800|134|N|rate, blood pressure) may be done while you are using this||
0800|135|N|medication. Keep all medical and lab appointments. Consult your||
0800|136|N|doctor for more details.||
0800|137|N|   Avoid allergens, irritants, smoking, and other factors that||
0800|138|N|make asthma worse.||
0800|139|N|   Learn to use a peak flow meter, use it daily, and promptly||
0800|140|N|report worsening asthma (such as readings in the yellow/red range||
0800|141|N|or increased use of quick-relief inhalers).||
0800|142|B|||
0800|143|D|MISSED DOSE:  Not applicable.||
0800|144|B|||
0800|145|R|STORAGE:  Store at room temperature. Keep the medication in the||
0800|146|R|original carton to protect from light. Discard any unused||
0800|147|R|portion. Keep all medications away from children and pets.||
0800|148|R|   Do not flush medications down the toilet or pour them into a||
0800|149|R|drain unless instructed to do so. Properly discard this product||
0800|150|R|when it is expired or no longer needed. Consult your pharmacist||
0800|151|R|or local waste disposal company.||
0800|152|B|||
0800|153|M|MEDICAL ALERT:  Your condition can cause complications in a||
0800|154|M|medical emergency. For information about enrolling in MedicAlert,||
0800|155|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0800|156|B|||
0800|157|A|Information last revised September 2024.||
0800|158|A|Copyright(c) 2025 First Databank, Inc.||
0800|159|B|||
0801|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0801|002|Z|does NOT have all possible information about this product. This||
0801|003|Z|information does not assure that this product is safe, effective,||
0801|004|Z|or appropriate for you. This information is not individual||
0801|005|Z|medical advice and does not substitute for the advice of your||
0801|006|Z|health care professional. Always ask your health care||
0801|007|Z|professional for complete information about this product and your||
0801|008|Z|specific health needs.||
0801|009|B|||
0801|010|T|CEFTAZIDIME - INJECTION||
0801|011|F|(sef-TAZ-i-deem)||
0801|012|B|||
0801|013|C|COMMON BRAND NAME(S): Fortaz, Tazicef||
0801|014|B|||
0801|015|U|USES:  Ceftazidime is used to treat a wide variety of bacterial||
0801|016|U|infections. This medication belongs to a class of drugs known as||
0801|017|U|cephalosporin antibiotics. It works by stopping the growth of||
0801|018|U|bacteria.||
0801|019|B|||
0801|020|H|HOW TO USE:  This medication is given by injection into a muscle||
0801|021|H|or vein as directed by your doctor, usually every 8 to 12 hours.||
0801|022|H|The dosage is based on your medical condition and response to||
0801|023|H|treatment. Children's dosage is also based on weight.||
0801|024|H|   If you are using this medication at home, learn all||
0801|025|H|preparation and usage instructions from your health care||
0801|026|H|professional. Before using, check this product for particles or||
0801|027|H|discoloration. If either is present, do not use the liquid. Learn||
0801|028|H|how to store and discard medical supplies safely.||
0801|029|H|   If you are using the frozen pre-mixed solution, thaw the bag||
0801|030|H|at room temperature or in the refrigerator. If the bag is thawed||
0801|031|H|in the refrigerator, let it sit at room temperature at least 1||
0801|032|H|hour before using. Do not thaw by putting in a water bath or||
0801|033|H|microwaving. After thawing, shake well and squeeze the bag to||
0801|034|H|check for leaks. Discard solution if the bag leaks. Do not||
0801|035|H|re-freeze the solution after thawing.||
0801|036|H|   For the best effect, use this antibiotic at evenly spaced||
0801|037|H|times. To help you remember, use this medication at the same||
0801|038|H|time(s) every day.||
0801|039|H|   Continue to use this medication for the full time prescribed,||
0801|040|H|even if symptoms disappear after a few days. Stopping the||
0801|041|H|medication too early may result in a return of the infection.||
0801|042|H|   Tell your doctor if your condition lasts or gets worse.||
0801|043|B|||
0801|044|S|SIDE EFFECTS:  Swelling, redness, or pain at the injection site||
0801|045|S|may occur. If any of these effects last or get worse, tell your||
0801|046|S|doctor or pharmacist promptly.||
0801|047|S|   Remember that this medication has been prescribed because your||
0801|048|S|doctor has judged that the benefit to you is greater than the||
0801|049|S|risk of side effects. Many people using this medication do not||
0801|050|S|have serious side effects.||
0801|051|S|   Tell your doctor right away if you have any serious side||
0801|052|S|effects, including: easy bruising/bleeding, unusual tiredness,||
0801|053|S|shaking, muscle spasms, uncontrollable movements, mental/mood||
0801|054|S|changes (such as confusion), seizures, signs of kidney problems||
0801|055|S|(such as change in the amount of urine), signs of liver problems||
0801|056|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
0801|057|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0801|058|S|   This medication may rarely cause a severe intestinal condition||
0801|059|S|due to a bacteria called C. difficile. This condition may occur||
0801|060|S|during treatment or weeks to months after treatment has stopped.||
0801|061|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0801|062|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0801|063|S|stool.||
0801|064|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0801|065|S|products because they may make symptoms worse.||
0801|066|S|   Use of this medication for prolonged or repeated periods may||
0801|067|S|result in oral thrush or a new yeast infection. Contact your||
0801|068|S|doctor if you notice white patches in your mouth, a change in||
0801|069|S|vaginal discharge, or other new symptoms.||
0801|070|S|   A very serious allergic reaction to this drug is rare.||
0801|071|S|However, get medical help right away if you notice any symptoms||
0801|072|S|of a serious allergic reaction, including: rash, itching/swelling||
0801|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0801|074|S|breathing.||
0801|075|S|   This is not a complete list of possible side effects. If you||
0801|076|S|notice other effects not listed above, contact your doctor or||
0801|077|S|pharmacist.||
0801|078|S|   In the US -||
0801|079|S|   Call your doctor for medical advice about side effects. You||
0801|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0801|081|S|www.fda.gov/medwatch.||
0801|082|S|   In Canada - Call your doctor for medical advice about side||
0801|083|S|effects. You may report side effects to Health Canada at||
0801|084|S|1-866-234-2345.||
0801|085|B|||
0801|086|P|PRECAUTIONS:  Before using ceftazidime, tell your doctor or||
0801|087|P|pharmacist if you are allergic to it; or to other antibiotics||
0801|088|P|(such as penicillins, other cephalosporins); or if you have any||
0801|089|P|other allergies. This product may contain inactive ingredients,||
0801|090|P|which can cause allergic reactions or other problems. Talk to||
0801|091|P|your pharmacist for more details.||
0801|092|P|   Before using this medication, tell your doctor or pharmacist||
0801|093|P|your medical history, especially of: kidney disease,||
0801|094|P|stomach/intestinal diseases (such as colitis).||
0801|095|P|   Ceftazidime may cause live bacterial vaccines (such as typhoid||
0801|096|P|vaccine) to not work well. Tell your health care professional||
0801|097|P|that you are using ceftazidime before having any||
0801|098|P|immunizations/vaccinations.||
0801|099|P|   Before having surgery, tell your doctor or dentist about all||
0801|100|P|the products you use (including prescription drugs,||
0801|101|P|nonprescription drugs, and herbal products).||
0801|102|P|   Tell your doctor if you are pregnant before using this||
0801|103|P|medication.||
0801|104|P|   This medication passes into breast milk in small amounts and||
0801|105|P|is unlikely to harm a nursing infant. Consult your doctor before||
0801|106|P|breastfeeding.||
0801|107|B|||
0801|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0801|109|I|medications work or increase your risk for serious side effects.||
0801|110|I|This document does not contain all possible drug interactions.||
0801|111|I|Keep a list of all the products you use (including||
0801|112|I|prescription/nonprescription drugs and herbal products) and share||
0801|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
0801|114|I|the dosage of any medicines without your doctor's approval.||
0801|115|I|   This medication may interfere with certain lab tests (such as||
0801|116|I|certain urine glucose tests), possibly causing false test||
0801|117|I|results. Make sure lab personnel and all your doctors know you||
0801|118|I|use this drug.||
0801|119|B|||
0801|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0801|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0801|122|O|poison control center right away. US residents can call||
0801|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0801|124|O|Symptoms of overdose may include: seizures, coma.||
0801|125|B|||
0801|126|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0801|127|N|kidney function) should be done while you are using this||
0801|128|N|medication. Keep all medical and lab appointments.||
0801|129|B|||
0801|130|D|MISSED DOSE:  It is important to get each dose of this medication||
0801|131|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0801|132|D|right away for a new dosing schedule. Do not double the dose to||
0801|133|D|catch up.||
0801|134|B|||
0801|135|R|STORAGE:  Consult the product instructions and your pharmacist||
0801|136|R|for storage details. Keep all medications away from children and||
0801|137|R|pets.||
0801|138|R|   Do not flush medications down the toilet or pour them into a||
0801|139|R|drain unless instructed to do so. Properly discard this product||
0801|140|R|when it is expired or no longer needed. Consult your pharmacist||
0801|141|R|or local waste disposal company.||
0801|142|B|||
0801|143|A|Information last revised January 2025.||
0801|144|A|Copyright(c) 2025 First Databank, Inc.||
0801|145|B|||
0804|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0804|002|Z|does NOT have all possible information about this product. This||
0804|003|Z|information does not assure that this product is safe, effective,||
0804|004|Z|or appropriate for you. This information is not individual||
0804|005|Z|medical advice and does not substitute for the advice of your||
0804|006|Z|health care professional. Always ask your health care||
0804|007|Z|professional for complete information about this product and your||
0804|008|Z|specific health needs.||
0804|009|B|||
0804|010|T|CEFOTETAN - INJECTION||
0804|011|F|(sef-oh-TEE-tan)||
0804|012|B|||
0804|013|C|COMMON BRAND NAME(S): Cefotan||
0804|014|B|||
0804|015|U|USES:  Cefotetan is an antibiotic used to treat a wide variety of||
0804|016|U|bacterial infections. It may also be used before and during||
0804|017|U|certain surgeries to help prevent infection. This medication is||
0804|018|U|known as a cephalosporin antibiotic. It works by stopping the||
0804|019|U|growth of bacteria.||
0804|020|B|||
0804|021|H|HOW TO USE:  This medication is given by injection into a muscle||
0804|022|H|or vein as directed by your doctor. The dosage is based on your||
0804|023|H|medical condition and response to treatment.||
0804|024|H|   If you are using this medication at home, learn all||
0804|025|H|preparation and usage instructions from your health care||
0804|026|H|professional. Before using, check the product for particles or||
0804|027|H|discoloration. If either is present, do not use the liquid. Learn||
0804|028|H|how to store and discard medical supplies safely.||
0804|029|H|   For the best effect, use this antibiotic at evenly spaced||
0804|030|H|times. To help you remember, use this medication at the same||
0804|031|H|time(s) every day.||
0804|032|H|   Continue to use this medication until the full prescribed||
0804|033|H|treatment period is finished, even if symptoms disappear after a||
0804|034|H|few days. Stopping the medication too early may result in a||
0804|035|H|return of the infection.||
0804|036|H|   Tell your doctor if your condition lasts or gets worse.||
0804|037|B|||
0804|038|S|SIDE EFFECTS:  Swelling, redness, pain, or soreness at the||
0804|039|S|injection site may occur. This medication may also rarely cause||
0804|040|S|loss of appetite, nausea, vomiting, diarrhea, or headache. If any||
0804|041|S|of these effects last or get worse, tell your doctor or||
0804|042|S|pharmacist promptly.||
0804|043|S|   Remember that this medication has been prescribed because your||
0804|044|S|doctor has judged that the benefit to you is greater than the||
0804|045|S|risk of side effects. Many people using this medication do not||
0804|046|S|have serious side effects.||
0804|047|S|   Tell your doctor right away if you have any serious side||
0804|048|S|effects, including: dark urine, easy bruising/bleeding,||
0804|049|S|fast/pounding/irregular heartbeat, seizures, unusual weakness,||
0804|050|S|yellowing eyes/skin, mental/mood changes (such as confusion).||
0804|051|S|   This medication may rarely cause a severe intestinal condition||
0804|052|S|due to a bacteria called C. difficile. This condition may occur||
0804|053|S|during treatment or weeks to months after treatment has stopped.||
0804|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0804|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0804|056|S|stool.||
0804|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0804|058|S|products because they may make symptoms worse.||
0804|059|S|   Use of this medication for prolonged or repeated periods may||
0804|060|S|result in oral thrush or a new vaginal yeast infection. Contact||
0804|061|S|your doctor if you notice white patches in your mouth, a change||
0804|062|S|in vaginal discharge, or other new symptoms.||
0804|063|S|   A very serious allergic reaction to this drug is rare.||
0804|064|S|However, get medical help right away if you notice any symptoms||
0804|065|S|of a serious allergic reaction, including: rash, itching/swelling||
0804|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0804|067|S|breathing.||
0804|068|S|   This is not a complete list of possible side effects. If you||
0804|069|S|notice other effects not listed above, contact your doctor or||
0804|070|S|pharmacist.||
0804|071|S|   In the US -||
0804|072|S|   Call your doctor for medical advice about side effects. You||
0804|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0804|074|S|www.fda.gov/medwatch.||
0804|075|S|   In Canada - Call your doctor for medical advice about side||
0804|076|S|effects. You may report side effects to Health Canada at||
0804|077|S|1-866-234-2345.||
0804|078|B|||
0804|079|P|PRECAUTIONS:  Before using cefotetan, tell your doctor or||
0804|080|P|pharmacist if you are allergic to it; or to other cephalosporins;||
0804|081|P|or to penicillins; or if you have any other allergies. This||
0804|082|P|product may contain inactive ingredients, which can cause||
0804|083|P|allergic reactions or other problems. Talk to your pharmacist for||
0804|084|P|more details.||
0804|085|P|   Before using this medication, tell your doctor or pharmacist||
0804|086|P|your medical history, especially of: kidney disease, liver||
0804|087|P|disease, stomach/intestinal diseases (such as colitis), use/abuse||
0804|088|P|of alcohol.||
0804|089|P|   Avoid alcoholic beverages while taking this medication and for||
0804|090|P|at least 3 days after finishing this medicine. Drinking alcohol||
0804|091|P|may result in severe stomach upset/cramps, nausea, vomiting,||
0804|092|P|headache, and flushing.||
0804|093|P|   Cefotetan may cause live bacterial vaccines (such as typhoid||
0804|094|P|vaccine) to not work well. Tell your health care professional||
0804|095|P|that you are using cefotetan before having any||
0804|096|P|immunizations/vaccinations.||
0804|097|P|   Tell your doctor if you are pregnant before using this||
0804|098|P|medication.||
0804|099|P|   This medication passes into breast milk. Consult your doctor||
0804|100|P|before breastfeeding.||
0804|101|B|||
0804|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0804|103|I|medications work or increase your risk for serious side effects.||
0804|104|I|This document does not contain all possible drug interactions.||
0804|105|I|Keep a list of all the products you use (including||
0804|106|I|prescription/nonprescription drugs and herbal products) and share||
0804|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
0804|108|I|the dosage of any medicines without your doctor's approval.||
0804|109|I|   Some products that may interact with these drugs are:||
0804|110|I|aminoglycoside antibiotics (such as tobramycin, gentamicin),||
0804|111|I|"blood thinners" (such as warfarin).||
0804|112|I|   This medication may interfere with certain lab tests (such as||
0804|113|I|urine glucose tests, serum or urine creatinine tests), possibly||
0804|114|I|causing false test results. Make sure lab personnel and all your||
0804|115|I|doctors know you use this drug.||
0804|116|B|||
0804|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0804|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0804|119|O|poison control center right away. US residents can call||
0804|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0804|121|O|Symptoms of overdose may include: trouble breathing, seizures.||
0804|122|B|||
0804|123|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0804|124|N|kidney function) may be done while you are using this product.||
0804|125|N|Keep all medical and lab appointments. Consult your doctor for||
0804|126|N|more details.||
0804|127|B|||
0804|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0804|129|D|If it is near the time of the next dose, skip the missed dose.||
0804|130|D|Use your next dose at the regular time. Do not double the dose to||
0804|131|D|catch up.||
0804|132|B|||
0804|133|R|STORAGE:  Different brands/packaging of this medication have||
0804|134|R|different storage needs. Check the product package for||
0804|135|R|instructions on how to store your brand, or ask your pharmacist.||
0804|136|R|Keep all medications away from children and pets.||
0804|137|R|   Do not flush medications down the toilet or pour them into a||
0804|138|R|drain unless instructed to do so. Properly discard this product||
0804|139|R|when it is expired or no longer needed. Consult your pharmacist||
0804|140|R|or local waste disposal company.||
0804|141|B|||
0804|142|A|Information last revised February 2025.||
0804|143|A|Copyright(c) 2025 First Databank, Inc.||
0804|144|B|||
0805|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0805|002|Z|does NOT have all possible information about this product. This||
0805|003|Z|information does not assure that this product is safe, effective,||
0805|004|Z|or appropriate for you. This information is not individual||
0805|005|Z|medical advice and does not substitute for the advice of your||
0805|006|Z|health care professional. Always ask your health care||
0805|007|Z|professional for complete information about this product and your||
0805|008|Z|specific health needs.||
0805|009|B|||
0805|010|T|CEFUROXIME - INJECTION||
0805|011|F|(SEF-ue-ROX-eem)||
0805|012|B|||
0805|013|C|COMMON BRAND NAME(S): Zinacef||
0805|014|B|||
0805|015|U|USES:  Cefuroxime is used to treat a wide variety of bacterial||
0805|016|U|infections. It may also be used to prevent infection from certain||
0805|017|U|surgeries. This medication belongs to a class of drugs known as||
0805|018|U|cephalosporin antibiotics. It works by stopping the growth of||
0805|019|U|bacteria.||
0805|020|B|||
0805|021|H|HOW TO USE:  This medication is given by injection into a muscle||
0805|022|H|or vein as directed by your doctor, usually every 8 hours. The||
0805|023|H|dosage is based on your medical condition and response to||
0805|024|H|treatment.||
0805|025|H|   If you are using this medication at home, learn all||
0805|026|H|preparation and usage instructions from your health care||
0805|027|H|professional. Before using, check this product for particles or||
0805|028|H|discoloration. If either is present, do not use the liquid. Learn||
0805|029|H|how to store and discard medical supplies safely.||
0805|030|H|   If you are using the frozen pre-mixed solution, thaw the bag||
0805|031|H|at room temperature or in the refrigerator. If the bag is thawed||
0805|032|H|in the refrigerator, let it sit at room temperature at least 1||
0805|033|H|hour before using. Do not thaw by putting in a water bath or||
0805|034|H|microwaving. After thawing, shake well and squeeze the bag to||
0805|035|H|check for leaks. Discard solution if the bag leaks. Do not||
0805|036|H|re-freeze the solution after thawing.||
0805|037|H|   For the best effect, use this antibiotic at evenly spaced||
0805|038|H|times. To help you remember, use this medication at the same||
0805|039|H|time(s) every day.||
0805|040|H|   Continue to use this medication for the full time prescribed,||
0805|041|H|even if symptoms disappear after a few days. Stopping the||
0805|042|H|medication too early may result in a return of the infection.||
0805|043|H|   Tell your doctor if your condition lasts or gets worse.||
0805|044|B|||
0805|045|S|SIDE EFFECTS:  Swelling, redness, or pain at the injection site||
0805|046|S|may occur. If any of these effects last or get worse, tell your||
0805|047|S|doctor or pharmacist promptly.||
0805|048|S|   Remember that this medication has been prescribed because your||
0805|049|S|doctor has judged that the benefit to you is greater than the||
0805|050|S|risk of side effects. Many people using this medication do not||
0805|051|S|have serious side effects.||
0805|052|S|   Tell your doctor right away if you have any serious side||
0805|053|S|effects, including: easy bruising/bleeding, unusual tiredness,||
0805|054|S|uncontrollable movements, mental/mood changes (such as||
0805|055|S|confusion), seizures, signs of kidney problems (such as change in||
0805|056|S|the amount of urine), signs of liver problems (such as||
0805|057|S|nausea/vomiting that doesn't stop, loss of appetite,||
0805|058|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0805|059|S|   This medication may rarely cause a severe intestinal condition||
0805|060|S|due to a bacteria called C. difficile. This condition may occur||
0805|061|S|during treatment or weeks to months after treatment has stopped.||
0805|062|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0805|063|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0805|064|S|stool.||
0805|065|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0805|066|S|products because they may make symptoms worse.||
0805|067|S|   Use of this medication for prolonged or repeated periods may||
0805|068|S|result in oral thrush or a new yeast infection. Contact your||
0805|069|S|doctor if you notice white patches in your mouth, a change in||
0805|070|S|vaginal discharge, or other new symptoms.||
0805|071|S|   A very serious allergic reaction to this drug is rare.||
0805|072|S|However, get medical help right away if you notice any symptoms||
0805|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0805|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0805|075|S|breathing.||
0805|076|S|   This is not a complete list of possible side effects. If you||
0805|077|S|notice other effects not listed above, contact your doctor or||
0805|078|S|pharmacist.||
0805|079|S|   In the US -||
0805|080|S|   Call your doctor for medical advice about side effects. You||
0805|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0805|082|S|www.fda.gov/medwatch.||
0805|083|S|   In Canada - Call your doctor for medical advice about side||
0805|084|S|effects. You may report side effects to Health Canada at||
0805|085|S|1-866-234-2345.||
0805|086|B|||
0805|087|P|PRECAUTIONS:  Before using cefuroxime, tell your doctor or||
0805|088|P|pharmacist if you are allergic to it; or to other antibiotics||
0805|089|P|(such as penicillins, other cephalosporins); or if you have any||
0805|090|P|other allergies. This product may contain inactive ingredients,||
0805|091|P|which can cause allergic reactions or other problems. Talk to||
0805|092|P|your pharmacist for more details.||
0805|093|P|   Before using this medication, tell your doctor or pharmacist||
0805|094|P|your medical history, especially of: kidney disease,||
0805|095|P|stomach/intestinal diseases (such as colitis).||
0805|096|P|   Cefuroxime may cause live bacterial vaccines (such as typhoid||
0805|097|P|vaccine) to not work well. Tell your health care professional||
0805|098|P|that you are using cefuroxime before having any||
0805|099|P|immunizations/vaccinations.||
0805|100|P|   Before having surgery, tell your doctor or dentist about all||
0805|101|P|the products you use (including prescription drugs,||
0805|102|P|nonprescription drugs, and herbal products).||
0805|103|P|   Tell your doctor if you are pregnant before using this||
0805|104|P|medication.||
0805|105|P|   This medication passes into breast milk in small amounts and||
0805|106|P|is unlikely to harm a nursing infant. Consult your doctor before||
0805|107|P|breastfeeding.||
0805|108|B|||
0805|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0805|110|I|medications work or increase your risk for serious side effects.||
0805|111|I|This document does not contain all possible drug interactions.||
0805|112|I|Keep a list of all the products you use (including||
0805|113|I|prescription/nonprescription drugs and herbal products) and share||
0805|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
0805|115|I|the dosage of any medicines without your doctor's approval.||
0805|116|I|   This medication may interfere with certain lab tests||
0805|117|I|(including certain urine glucose tests), possibly causing false||
0805|118|I|test results. Make sure lab personnel and all your doctors know||
0805|119|I|you use this drug.||
0805|120|B|||
0805|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0805|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0805|123|O|poison control center right away. US residents can call||
0805|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0805|125|O|Symptoms of overdose may include: seizures.||
0805|126|B|||
0805|127|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0805|128|N|kidney function) should be done while you are using this||
0805|129|N|medication. Keep all medical and lab appointments.||
0805|130|B|||
0805|131|D|MISSED DOSE:  It is important to get each dose of this medication||
0805|132|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0805|133|D|right away for a new dosing schedule. Do not double the dose to||
0805|134|D|catch up.||
0805|135|B|||
0805|136|R|STORAGE:  Consult the product instructions and your pharmacist||
0805|137|R|for storage details. Keep all medications away from children and||
0805|138|R|pets.||
0805|139|R|   Do not flush medications down the toilet or pour them into a||
0805|140|R|drain unless instructed to do so. Properly discard this product||
0805|141|R|when it is expired or no longer needed. Consult your pharmacist||
0805|142|R|or local waste disposal company.||
0805|143|B|||
0805|144|A|Information last revised January 2025.||
0805|145|A|Copyright(c) 2025 First Databank, Inc.||
0805|146|B|||
0806|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0806|002|Z|does NOT have all possible information about this product. This||
0806|003|Z|information does not assure that this product is safe, effective,||
0806|004|Z|or appropriate for you. This information is not individual||
0806|005|Z|medical advice and does not substitute for the advice of your||
0806|006|Z|health care professional. Always ask your health care||
0806|007|Z|professional for complete information about this product and your||
0806|008|Z|specific health needs.||
0806|009|B|||
0806|010|T|ACETAMINOPHEN/CAFFEINE/DIHYDROCODEINE - ORAL||
0806|011|F|(a-SEET-a-MIN-oh-fen/KAF-een/dye-HYE-droe-KOE-deen)||
0806|012|B|||
0806|013|C|COMMON BRAND NAME(S): Panlor SS, Trezix||
0806|014|B|||
0806|015|W|WARNING:  Dihydrocodeine has a risk for abuse and addiction,||
0806|016|W|which can lead to overdose and death. Dihydrocodeine may also||
0806|017|W|cause severe, possibly fatal, breathing problems. To lower your||
0806|018|W|risk, your doctor should have you take the smallest dose of||
0806|019|W|dihydrocodeine that works, and take it for the shortest possible||
0806|020|W|time. See also How to Use section for more information about||
0806|021|W|addiction.||
0806|022|W|   Ask your doctor or pharmacist if you should have medication||
0806|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0806|024|W|Teach your family or household members about the signs of an||
0806|025|W|opioid overdose and how to treat it.||
0806|026|W|   The risk for severe breathing problems is higher when you||
0806|027|W|start this medication and after a dose increase, or if you take||
0806|028|W|the wrong dose/strength. Taking this medication with alcohol or||
0806|029|W|other drugs that can cause drowsiness or breathing problems may||
0806|030|W|cause very serious side effects, including death. Also, other||
0806|031|W|medications can affect the removal of dihydrocodeine from your||
0806|032|W|body, which may affect how dihydrocodeine works. Be sure you know||
0806|033|W|how to take this medication and what other drugs you should avoid||
0806|034|W|taking with it. See also Drug Interactions section. Get medical||
0806|035|W|help right away if any of these very serious side effects occur:||
0806|036|W|slow/shallow breathing, unusual lightheadedness, severe||
0806|037|W|drowsiness/dizziness, difficulty waking up.||
0806|038|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0806|039|W|or abuse. If someone accidentally swallows this drug, get medical||
0806|040|W|help right away.||
0806|041|W|   One ingredient in this product is acetaminophen. Taking too||
0806|042|W|much acetaminophen may cause serious (possibly fatal) liver||
0806|043|W|disease. Adults should not take more than 4000 milligrams (4||
0806|044|W|grams) of acetaminophen a day. People with liver problems and||
0806|045|W|children should take less acetaminophen. Ask your doctor or||
0806|046|W|pharmacist how much acetaminophen is safe to take.||
0806|047|W|   Do not use with any other drug containing acetaminophen||
0806|048|W|without asking your doctor or pharmacist first. Acetaminophen is||
0806|049|W|in many nonprescription and prescription medications (such as||
0806|050|W|pain/fever drugs or cough-and-cold products). Check the labels on||
0806|051|W|all your medicines to see if they contain acetaminophen, and ask||
0806|052|W|your pharmacist if you are unsure.||
0806|053|W|   Get medical help right away if you take too much acetaminophen||
0806|054|W|(overdose), even if you feel well. Overdose symptoms may include||
0806|055|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
0806|056|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
0806|057|W|   Daily alcohol use, especially when combined with||
0806|058|W|acetaminophen, may damage your liver. Avoid alcohol.||
0806|059|W|   Before using this medication, women of childbearing age should||
0806|060|W|talk with their doctor(s) about the risks and benefits. Tell your||
0806|061|W|doctor if you are pregnant or if you plan to become pregnant.||
0806|062|W|During pregnancy, this medication should be used only when||
0806|063|W|clearly needed. It may slightly increase the risk of birth||
0806|064|W|defects if used during the first two months of pregnancy. Also,||
0806|065|W|using it for a long time or in high doses near the expected||
0806|066|W|delivery date may harm the unborn baby. To lessen the risk, take||
0806|067|W|the smallest effective dose for the shortest possible time.||
0806|068|W|Babies born to mothers who use this drug for a long time may||
0806|069|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0806|070|W|doctor right away if you notice any symptoms in your newborn baby||
0806|071|W|such as crying that doesn't stop, slow/shallow breathing,||
0806|072|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0806|073|W|difficulty gaining weight.||
0806|074|W|   Children younger than 18 years should not use products that||
0806|075|W|contain dihydrocodeine. Some children are more sensitive to||
0806|076|W|dihydrocodeine and have had very serious (rarely fatal) breathing||
0806|077|W|problems such as slow/shallow breathing (see also Side Effects||
0806|078|W|section). The risk is greater in children who are obese or have||
0806|079|W|breathing problems, or after certain surgeries (including||
0806|080|W|tonsil/adenoid removal). Talk with your doctor or pharmacist||
0806|081|W|about the risks and benefits of this medication.||
0806|082|B|||
0806|083|U|USES:  See also Warning section.||
0806|084|U|   This combination medication is used to help relieve moderate||
0806|085|U|to severe pain. It contains an opioid pain reliever||
0806|086|U|(dihydrocodeine), a non-opioid pain reliever (acetaminophen), and||
0806|087|U|caffeine. Dihydrocodeine works in the brain to change how your||
0806|088|U|body feels and responds to pain. Acetaminophen can also reduce a||
0806|089|U|fever. Caffeine increases pain relief, especially for certain||
0806|090|U|types of headaches.||
0806|091|B|||
0806|092|H|HOW TO USE:  See also Warning section.||
0806|093|H|   Read the Medication Guide provided by your pharmacist before||
0806|094|H|you start taking acetaminophen/caffeine/dihydrocodeine and each||
0806|095|H|time you get a refill. If you have any questions, ask your doctor||
0806|096|H|or pharmacist.||
0806|097|H|   Take this medication by mouth as directed by your doctor,||
0806|098|H|usually every 4 hours as needed for pain. You may take this drug||
0806|099|H|with or without food. If you have nausea, it may help to take||
0806|100|H|this drug with food. Ask your doctor or pharmacist about other||
0806|101|H|ways to decrease nausea (such as lying down for 1 to 2 hours with||
0806|102|H|as little head movement as possible).||
0806|103|H|   The dosage is based on your medical condition and response to||
0806|104|H|treatment. Do not increase your dose or use this drug more often||
0806|105|H|or for longer than prescribed because your risk of side effects||
0806|106|H|may increase. Properly stop the medication when so directed.||
0806|107|H|   Pain medications work best if they are used as the first signs||
0806|108|H|of pain occur. If you wait until the pain has worsened, the||
0806|109|H|medication may not work as well.||
0806|110|H|   This product contains caffeine. Avoid drinking large amounts||
0806|111|H|of beverages containing caffeine (coffee, tea, colas), eating||
0806|112|H|large amounts of chocolate, or taking nonprescription products||
0806|113|H|that contain caffeine.||
0806|114|H|   Suddenly stopping this medication may cause withdrawal,||
0806|115|H|especially if you have used it for a long time or in high doses.||
0806|116|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0806|117|H|Tell your doctor or pharmacist right away if you have any||
0806|118|H|withdrawal symptoms such as restlessness, mental/mood changes||
0806|119|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0806|120|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0806|121|H|aches, or sudden changes in behavior.||
0806|122|H|   When this medication is used for a long time, it may not work||
0806|123|H|as well. Talk with your doctor if this medication stops working||
0806|124|H|well.||
0806|125|H|   Though it helps many people, this medication may sometimes||
0806|126|H|cause addiction. This risk may be higher if you have a||
0806|127|H|mental/mood disorder or a substance use disorder (such as overuse||
0806|128|H|of or addiction to drugs/alcohol). Take this medication exactly||
0806|129|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0806|130|H|pharmacist for more details.||
0806|131|H|   Tell your doctor if your pain does not get better or if it||
0806|132|H|gets worse, or if you have any new pain.||
0806|133|B|||
0806|134|S|SIDE EFFECTS:  See also Warning section.||
0806|135|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0806|136|S|drowsiness, headache, increased urination, or trouble sleeping||
0806|137|S|may occur. If any of these effects last or get worse, tell your||
0806|138|S|doctor or pharmacist promptly.||
0806|139|S|   To prevent constipation, eat dietary fiber, drink enough||
0806|140|S|water, and exercise. You may also need to take a laxative. Ask||
0806|141|S|your pharmacist which type of laxative is right for you.||
0806|142|S|   To reduce the risk of dizziness and lightheadedness, get up||
0806|143|S|slowly when rising from a sitting or lying position.||
0806|144|S|   Remember that this medication has been prescribed because your||
0806|145|S|doctor has judged that the benefit to you is greater than the||
0806|146|S|risk of side effects. Many people using this medication do not||
0806|147|S|have serious side effects.||
0806|148|S|   Tell your doctor right away if you have any serious side||
0806|149|S|effects, including: interrupted breathing during sleep (sleep||
0806|150|S|apnea), mental/mood changes (such as irritability, nervousness,||
0806|151|S|anxiety, hallucinations), fast/irregular heartbeat,||
0806|152|S|stomach/abdominal pain, difficulty urinating, vision changes,||
0806|153|S|shaking (tremor), signs of your adrenal glands not working well||
0806|154|S|(such as loss of appetite, unusual tiredness, weight loss),||
0806|155|S|trouble swallowing.||
0806|156|S|   Get medical help right away if you have any very serious side||
0806|157|S|effects, including: fainting, seizure.||
0806|158|S|   Dihydrocodeine is changed into a strong opioid drug||
0806|159|S|(dihydromorphine) in your body. In some people, this change||
0806|160|S|happens faster and more completely than usual, which increases||
0806|161|S|the risk of very serious side effects. Get medical help right||
0806|162|S|away if you notice any of the following: slow/shallow breathing,||
0806|163|S|severe drowsiness/difficulty waking up, confusion.||
0806|164|S|   A very serious allergic reaction to this drug is rare.||
0806|165|S|However, get medical help right away if you notice any symptoms||
0806|166|S|of a serious allergic reaction, including: rash, itching/swelling||
0806|167|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0806|168|S|breathing.||
0806|169|S|   This is not a complete list of possible side effects. If you||
0806|170|S|notice other effects not listed above, contact your doctor or||
0806|171|S|pharmacist.||
0806|172|S|   In the US -||
0806|173|S|   Call your doctor for medical advice about side effects. You||
0806|174|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0806|175|S|www.fda.gov/medwatch.||
0806|176|S|   In Canada - Call your doctor for medical advice about side||
0806|177|S|effects. You may report side effects to Health Canada at||
0806|178|S|1-866-234-2345.||
0806|179|B|||
0806|180|P|PRECAUTIONS:  See also Warning section.||
0806|181|P|   Before taking this product, tell your doctor or pharmacist if||
0806|182|P|you are allergic to dihydrocodeine, acetaminophen, or caffeine;||
0806|183|P|or to other opioid pain medications (such as codeine, morphine);||
0806|184|P|or if you have any other allergies. This product may contain||
0806|185|P|inactive ingredients, which can cause allergic reactions or other||
0806|186|P|problems. Talk to your pharmacist for more details.||
0806|187|P|   Before using this medication, tell your doctor or pharmacist||
0806|188|P|your medical history, especially of: brain disorders (such as||
0806|189|P|head injury, tumor, seizures), breathing problems (such as||
0806|190|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0806|191|P|gallbladder disease, heart problems (such as irregular heartbeat,||
0806|192|P|recent heart attack), kidney disease, liver disease, mental/mood||
0806|193|P|disorders (such as confusion, depression, thoughts of suicide),||
0806|194|P|personal or family history of a substance use disorder (such as||
0806|195|P|overuse of or addiction to drugs/alcohol), obesity,||
0806|196|P|stomach/intestinal problems (such as blockage, constipation,||
0806|197|P|diarrhea due to infection, paralytic ileus), disease of the||
0806|198|P|pancreas (pancreatitis), difficulty urinating (such as due to||
0806|199|P|enlarged prostate).||
0806|200|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0806|201|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0806|202|P|machinery, or do anything that needs alertness until you can do||
0806|203|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0806|204|P|are using marijuana (cannabis).||
0806|205|P|   Before having surgery or certain medical procedures (such as a||
0806|206|P|heart stress test or a procedure to restore a normal heart rhythm||
0806|207|P|if you have an unusually fast heartbeat), tell your doctor or||
0806|208|P|dentist that you use this medication and about all the products||
0806|209|P|you use (including prescription drugs, nonprescription drugs, and||
0806|210|P|herbal products).||
0806|211|P|   Older adults may be more sensitive to the side effects of this||
0806|212|P|drug, especially confusion, dizziness, drowsiness, trouble||
0806|213|P|sleeping, and slow/shallow breathing.||
0806|214|P|   During pregnancy, this medication should be used only when||
0806|215|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0806|216|P|benefits with your doctor.||
0806|217|P|   This medication passes into breast milk and may have||
0806|218|P|undesirable effects on a nursing infant, such as unusual||
0806|219|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
0806|220|P|limpness. Consult your doctor before breastfeeding.||
0806|221|B|||
0806|222|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
0806|223|I|   Drug interactions may change how your medications work or||
0806|224|I|increase your risk for serious side effects. This document does||
0806|225|I|not contain all possible drug interactions. Keep a list of all||
0806|226|I|the products you use (including prescription/nonprescription||
0806|227|I|drugs and herbal products) and share it with your doctor and||
0806|228|I|pharmacist. Do not start, stop, or change the dosage of any||
0806|229|I|medicines without your doctor's approval.||
0806|230|I|   Some products that may interact with this drug include:||
0806|231|I|certain pain medications (mixed opioid agonist-antagonists such||
0806|232|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0806|233|I|samidorphan.||
0806|234|I|   The risk of serious side effects (such as slow/shallow||
0806|235|I|breathing, severe drowsiness/dizziness) may be increased if this||
0806|236|I|medication is taken with other products that may also cause||
0806|237|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0806|238|I|if you are taking other products such as other opioid pain or||
0806|239|I|cough relievers (such as morphine, hydrocodone), alcohol,||
0806|240|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0806|241|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0806|242|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0806|243|I|cetirizine, diphenhydramine).||
0806|244|I|   Check the labels on all your medicines (such as allergy or||
0806|245|I|cough-and-cold products, pain relievers) because they may also||
0806|246|I|contain acetaminophen, caffeine, or ingredients that cause||
0806|247|I|drowsiness. Ask your pharmacist about using those products||
0806|248|I|safely.||
0806|249|I|   Other medications can affect the removal of this product from||
0806|250|I|your body, which may affect how this product works. Examples||
0806|251|I|include azole antifungals (such as ketoconazole), bupropion,||
0806|252|I|fluoxetine, levoketoconazole, macrolide antibiotics (such as||
0806|253|I|erythromycin), mifepristone, paroxetine, quinidine, rifamycins||
0806|254|I|(such as rifabutin, rifampin), ritonavir, certain drugs used to||
0806|255|I|treat seizures (such as carbamazepine, phenytoin), among others.||
0806|256|I|   This medication may interfere with certain medical/lab tests||
0806|257|I|(such as certain urine tests, amylase/lipase levels,||
0806|258|I|dipyridamole-thallium imaging tests), possibly causing false test||
0806|259|I|results. Make sure lab personnel and all your doctors know you||
0806|260|I|use this drug.||
0806|261|B|||
0806|262|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0806|263|O|as passing out or trouble breathing, give them naloxone or||
0806|264|O|nalmefene if available, then call 911. If the person is awake and||
0806|265|O|has no symptoms, call a poison control center right away. US||
0806|266|O|residents can call 1-800-222-1222. Canada residents can call||
0806|267|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0806|268|O|breathing, coma, seizures, nausea, vomiting, loss of appetite,||
0806|269|O|sweating, stomach/abdominal pain, extreme tiredness, yellowing||
0806|270|O|eyes/skin, dark urine.||
0806|271|B|||
0806|272|N|NOTES:  Do not share this medication with others. Sharing it is||
0806|273|N|against the law.||
0806|274|N|   This medication has been prescribed for your current condition||
0806|275|N|only. Do not use it later for another condition unless your||
0806|276|N|doctor directs you to do so. A different medication may be||
0806|277|N|necessary in that case.||
0806|278|B|||
0806|279|D|MISSED DOSE:  Not applicable.||
0806|280|B|||
0806|281|R|STORAGE:  Store at room temperature away from light and moisture.||
0806|282|R|Do not store in the bathroom. Keep all medications away from||
0806|283|R|children and pets.||
0806|284|R|   Do not flush medications down the toilet or pour them into a||
0806|285|R|drain unless instructed to do so. Properly discard this product||
0806|286|R|when it is expired or no longer needed. Consult your pharmacist||
0806|287|R|or local waste disposal company.||
0806|288|B|||
0806|289|A|Information last revised August 2025.||
0806|290|A|Copyright(c) 2025 First Databank, Inc.||
0806|291|B|||
0807|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0807|002|Z|does NOT have all possible information about this product. This||
0807|003|Z|information does not assure that this product is safe, effective,||
0807|004|Z|or appropriate for you. This information is not individual||
0807|005|Z|medical advice and does not substitute for the advice of your||
0807|006|Z|health care professional. Always ask your health care||
0807|007|Z|professional for complete information about this product and your||
0807|008|Z|specific health needs.||
0807|009|B|||
0807|010|T|ETONOGESTREL - IMPLANT||
0807|011|F|(e-TOE-noe-JES-trel)||
0807|012|B|||
0807|013|C|COMMON BRAND NAME(S): Implanon, Nexplanon||
0807|014|B|||
0807|015|U|USES:  This product is a small, thin plastic rod that is inserted||
0807|016|U|under the skin to prevent pregnancy. The rod slowly releases||
0807|017|U|etonogestrel into the body over a 3-year period. Etonogestrel is||
0807|018|U|similar to a natural hormone made in your body. This product does||
0807|019|U|not contain any estrogen.||
0807|020|U|   This medication may not work as well in women who are very||
0807|021|U|overweight or those taking certain drugs. (See also Drug||
0807|022|U|Interactions section.) Discuss your birth control options with||
0807|023|U|your doctor.||
0807|024|U|   This medication does not protect against sexually transmitted||
0807|025|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
0807|026|U|an effective barrier method (latex or polyurethane condom/dental||
0807|027|U|dams) during sexual activity will help to decrease your risk of||
0807|028|U|infection.||
0807|029|B|||
0807|030|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0807|031|H|your pharmacist or health care provider before the rod is placed.||
0807|032|H|If you have any questions, ask your doctor or pharmacist.||
0807|033|H|   Ask your doctor about the best time to schedule your||
0807|034|H|appointment to have the rod placed. Your doctor may want you to||
0807|035|H|have a pregnancy test first. The medication usually starts||
0807|036|H|working right away when the rod is inserted during the first 5||
0807|037|H|days of your period. If your appointment is at another time in||
0807|038|H|your menstrual cycle, you may need to use a non-hormonal form of||
0807|039|H|birth control (such as condoms, diaphragm, spermicide) for the||
0807|040|H|first 7 days after the rod is placed. Ask your doctor about||
0807|041|H|whether you need backup birth control.||
0807|042|H|   The rod will be inserted under the skin in your upper arm by a||
0807|043|H|health care professional. Usually it will be placed in the arm||
0807|044|H|that you do not write with. Be sure you can feel the rod||
0807|045|H|underneath your skin after it has been placed. If at any time you||
0807|046|H|cannot feel the rod underneath the skin or feel that the rod has||
0807|047|H|been bent or broken, tell your doctor right away.||
0807|048|H|   There will be 2 bandages covering the area where the rod is||
0807|049|H|placed. Leave the top bandage on for 24 hours. Keep the smaller||
0807|050|H|bandage on as directed by your doctor, usually for 3 to 5 days.||
0807|051|H|Keep the bandage clean and dry.||
0807|052|H|   The rod must be removed after 3 years and can be replaced if||
0807|053|H|continued birth control is desired. The rod can be removed at any||
0807|054|H|time by a trained health care professional if birth control is no||
0807|055|H|longer desired or if there are side effects.||
0807|056|B|||
0807|057|S|SIDE EFFECTS:  Nausea, stomach cramping/bloating, dizziness,||
0807|058|S|headache, breast tenderness, acne, hair loss, weight gain, and||
0807|059|S|vaginal irritation/discharge may occur. Pain, bruising, numbness,||
0807|060|S|infection, and scarring may occur at the site where the rod is||
0807|061|S|placed. If any of these effects last or get worse, tell your||
0807|062|S|doctor or pharmacist promptly.||
0807|063|S|   Your periods may be early or late, shorter or longer, heavier||
0807|064|S|or lighter than normal. You may also have some spotting between||
0807|065|S|periods, especially during the first several months of use. If||
0807|066|S|bleeding is prolonged (more than 8 days) or unusually heavy,||
0807|067|S|contact your doctor. If you miss 2 periods in a row, contact your||
0807|068|S|doctor for a pregnancy test.||
0807|069|S|   Remember that this medication has been prescribed because your||
0807|070|S|doctor has judged that the benefit to you is greater than the||
0807|071|S|risk of side effects. Many people using this medication do not||
0807|072|S|have serious side effects.||
0807|073|S|   Tell your doctor right away if you have any serious side||
0807|074|S|effects, including: mental/mood changes (such as new/worsening||
0807|075|S|depression), lump in the breast, unwanted facial/body hair,||
0807|076|S|severe stomach/abdominal/pelvic pain, unusual tiredness, dark||
0807|077|S|urine, yellowing eyes/skin, coughing up blood.||
0807|078|S|   Rarely, people using this medication have had very serious||
0807|079|S|(possibly fatal) problems from blood clots (such as heart attack,||
0807|080|S|stroke, blood clots in the lungs, legs, or eyes). Get medical||
0807|081|S|help right away if you have: shortness of breath/rapid breathing,||
0807|082|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
0807|083|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
0807|084|S|sudden/severe headaches, trouble speaking, weakness on one side||
0807|085|S|of the body, sudden vision changes.||
0807|086|S|   A very serious allergic reaction to this drug is rare.||
0807|087|S|However, get medical help right away if you notice any symptoms||
0807|088|S|of a serious allergic reaction, including: rash, itching/swelling||
0807|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0807|090|S|breathing.||
0807|091|S|   This is not a complete list of possible side effects. If you||
0807|092|S|notice other effects not listed above, contact your doctor or||
0807|093|S|pharmacist.||
0807|094|S|   In the US -||
0807|095|S|   Call your doctor for medical advice about side effects. You||
0807|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0807|097|S|www.fda.gov/medwatch.||
0807|098|S|   In Canada - Call your doctor for medical advice about side||
0807|099|S|effects. You may report side effects to Health Canada at||
0807|100|S|1-866-234-2345.||
0807|101|B|||
0807|102|P|PRECAUTIONS:  Before using etonogestrel, tell your doctor or||
0807|103|P|pharmacist if you are allergic to it; or to other progestins||
0807|104|P|(such as norethindrone, desogestrel); or to any anesthetics or||
0807|105|P|antiseptics that might be used in the procedure; or if you have||
0807|106|P|any other allergies. This product may contain inactive||
0807|107|P|ingredients, which can cause allergic reactions or other||
0807|108|P|problems. Talk to your pharmacist for more details.||
0807|109|P|   Before using this medication, tell your doctor or pharmacist||
0807|110|P|your medical history, especially of: blood clots (for example in||
0807|111|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
0807|112|P|C or protein S deficiency), high blood pressure, abnormal breast||
0807|113|P|exam, personal or family history of cancer (especially breast or||
0807|114|P|cervical cancer), high cholesterol or triglyceride (blood fat)||
0807|115|P|levels, depression, diabetes, gall bladder problems, severe||
0807|116|P|headaches/migraine, heart problems (such as heart valve disease,||
0807|117|P|irregular heartbeat, previous heart attack), history of yellowing||
0807|118|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
0807|119|P|birth control (such as pills, patch), kidney disease, liver||
0807|120|P|disease (including tumors), smoking, stroke, swelling (edema),||
0807|121|P|unexplained vaginal bleeding.||
0807|122|P|   Before having surgery, tell your doctor or dentist about all||
0807|123|P|the products you use (including prescription drugs,||
0807|124|P|nonprescription drugs, and herbal products).||
0807|125|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0807|126|P|can make you more dizzy. Do not drive, use machinery, or do||
0807|127|P|anything that needs alertness until you can do it safely. Limit||
0807|128|P|alcoholic beverages. Talk to your doctor if you are using||
0807|129|P|marijuana (cannabis).||
0807|130|P|   This medication may cause blotchy, dark areas on your face and||
0807|131|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0807|132|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0807|133|P|wear protective clothing when outdoors.||
0807|134|P|   If you are nearsighted or wear contact lenses, you may develop||
0807|135|P|vision problems or trouble wearing your contact lenses. Contact||
0807|136|P|your eye doctor if these problems occur.||
0807|137|P|   This product must not be used during pregnancy. If you become||
0807|138|P|pregnant or think you may be pregnant, tell your doctor right||
0807|139|P|away. A certain serious pregnancy problem (ectopic pregnancy) may||
0807|140|P|be more likely if you become pregnant while using this product.||
0807|141|P|   This medication passes into breast milk. Consult your doctor||
0807|142|P|before breastfeeding.||
0807|143|B|||
0807|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0807|145|I|medications work or increase your risk for serious side effects.||
0807|146|I|This document does not contain all possible drug interactions.||
0807|147|I|Keep a list of all the products you use (including||
0807|148|I|prescription/nonprescription drugs and herbal products) and share||
0807|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
0807|150|I|the dosage of any medicines without your doctor's approval.||
0807|151|I|   Some drugs may cause hormonal birth control to work less well||
0807|152|I|by decreasing the amount of birth control hormones in your body.||
0807|153|I|This effect can result in pregnancy. Examples include||
0807|154|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
0807|155|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
0807|156|I|seizures (such as barbiturates, carbamazepine, felbamate,||
0807|157|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
0807|158|I|nevirapine), among others.||
0807|159|I|   Tell your doctor when you start any new drug, and discuss if||
0807|160|I|you should use reliable backup birth control. Also tell your||
0807|161|I|doctor if you have any new spotting or breakthrough bleeding,||
0807|162|I|because these may be signs that your birth control is not working||
0807|163|I|well.||
0807|164|I|   This medication may interfere with certain lab tests (such as||
0807|165|I|sex-hormone-binding globulin, thyroid), possibly causing false||
0807|166|I|test results. Make sure lab personnel and all your doctors know||
0807|167|I|you use this drug.||
0807|168|B|||
0807|169|O|OVERDOSE:  This implant may be harmful if swallowed. If someone||
0807|170|O|has swallowed it and has serious symptoms such as passing out or||
0807|171|O|trouble breathing, call 911. Otherwise, call a poison control||
0807|172|O|center right away. US residents can call 1-800-222-1222. Canada||
0807|173|O|residents can call 1-844-764-7669.||
0807|174|B|||
0807|175|N|NOTES:  Regular complete physical exams which include lab and/or||
0807|176|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
0807|177|N|Pap smear) should be done while you are using this medication.||
0807|178|N|Follow your doctor's instructions for examining your breasts, and||
0807|179|N|report any lumps right away. Keep all medical and lab||
0807|180|N|appointments. Consult your doctor for more details.||
0807|181|B|||
0807|182|D|MISSED DOSE:  Not applicable.||
0807|183|B|||
0807|184|R|STORAGE:  Not applicable. This product is inserted in a hospital||
0807|185|R|or clinic or doctor's office and will not be stored at home.||
0807|186|B|||
0807|187|A|Information last revised October 2025.||
0807|188|A|Copyright(c) 2025 First Databank, Inc.||
0807|189|B|||
0808|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0808|002|Z|does NOT have all possible information about this product. This||
0808|003|Z|information does not assure that this product is safe, effective,||
0808|004|Z|or appropriate for you. This information is not individual||
0808|005|Z|medical advice and does not substitute for the advice of your||
0808|006|Z|health care professional. Always ask your health care||
0808|007|Z|professional for complete information about this product and your||
0808|008|Z|specific health needs.||
0808|009|B|||
0808|010|T|PIOGLITAZONE/GLIMEPIRIDE - ORAL||
0808|011|F|(PYE-oh-GLI-ta-zone/glih-MEH-pih-ride)||
0808|012|B|||
0808|013|C|COMMON BRAND NAME(S): Duetact||
0808|014|B|||
0808|015|W|WARNING:  Pioglitazone may rarely cause or worsen a certain heart||
0808|016|W|problem (heart failure). Tell your doctor right away if you||
0808|017|W|notice any symptoms of heart failure, including: shortness of||
0808|018|W|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
0808|019|W|weight gain.||
0808|020|W|   This medication is not recommended for people with certain||
0808|021|W|types of heart failure. Before using this medication, tell your||
0808|022|W|doctor if you have heart failure.||
0808|023|B|||
0808|024|U|USES:  This medication is a combination of 2 drugs, pioglitazone||
0808|025|U|and glimepiride. It is used along with a proper diet and exercise||
0808|026|U|program to control high blood sugar in patients with type 2||
0808|027|U|diabetes. Controlling high blood sugar helps prevent kidney||
0808|028|U|damage, blindness, nerve problems, loss of limbs, and sexual||
0808|029|U|function problems. Proper control of diabetes may also lessen||
0808|030|U|your risk of a heart attack or stroke.||
0808|031|U|   Pioglitazone belongs to a class of drugs known as||
0808|032|U|thiazolidinediones or "glitazones." It works by helping to||
0808|033|U|restore your body's proper response to insulin, thereby lowering||
0808|034|U|your blood sugar.||
0808|035|U|   Talk to your doctor about the risks and benefits of using||
0808|036|U|pioglitazone-containing products.||
0808|037|U|   Glimepiride belongs to a class of drugs known as||
0808|038|U|sulfonylureas. It works by causing the release of your body's||
0808|039|U|natural insulin.||
0808|040|B|||
0808|041|H|HOW TO USE:  Read the Medication Guide provided by your||
0808|042|H|pharmacist before you start taking this medication and each time||
0808|043|H|you get a refill. If you have any questions, ask your doctor or||
0808|044|H|pharmacist.||
0808|045|H|   Take this medication by mouth as directed by your doctor,||
0808|046|H|usually once daily with the first main meal of the day.||
0808|047|H|   The dosage is based on your medical condition and response to||
0808|048|H|treatment.||
0808|049|H|   Colesevelam can decrease the absorption of glimepiride. If you||
0808|050|H|are taking colesevelam, take this product at least 4 hours before||
0808|051|H|taking colesevelam.||
0808|052|H|   Use this medication regularly in order to get the most benefit||
0808|053|H|from it. Remember to take it at the same time each day. Monitor||
0808|054|H|your blood sugar on a regular basis, and share the results with||
0808|055|H|your doctor.||
0808|056|H|   It may take up to 2 to 3 months before you get the full||
0808|057|H|benefit of this drug.||
0808|058|B|||
0808|059|S|SIDE EFFECTS:  See also Warning section.||
0808|060|S|   Headache, dizziness, diarrhea, nausea, muscle pain, sore||
0808|061|S|throat, or tooth problems may occur. If any of these effects last||
0808|062|S|or get worse, tell your doctor or pharmacist promptly.||
0808|063|S|   Remember that this medication has been prescribed because your||
0808|064|S|doctor has judged that the benefit to you is greater than the||
0808|065|S|risk of side effects. Many people using this medication do not||
0808|066|S|have serious side effects.||
0808|067|S|   Tell your doctor right away if you have any serious side||
0808|068|S|effects, including: new/worsening vision problems (such as color||
0808|069|S|or night vision problems), bone fracture, reddish-colored urine,||
0808|070|S|urgent need to urinate, pain while urinating, signs of liver||
0808|071|S|disease (such as loss of appetite, yellowing eyes/skin, dark||
0808|072|S|urine), mental/mood changes (such as hallucinations, confusion),||
0808|073|S|seizures, easy bruising/bleeding, signs of infection (such as||
0808|074|S|sore throat that doesn't go away, fever, chills).||
0808|075|S|   This medication can cause low blood sugar (hypoglycemia). This||
0808|076|S|may occur if you do not get enough calories from food or if you||
0808|077|S|do unusually heavy exercise. Symptoms of low blood sugar include||
0808|078|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
0808|079|S|dizziness, or tingling hands/feet. It is a good habit to carry||
0808|080|S|glucose tablets or gel to treat low blood sugar. If you don't||
0808|081|S|have these reliable forms of glucose, rapidly raise your blood||
0808|082|S|sugar by eating a quick source of sugar such as table sugar,||
0808|083|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
0808|084|S|doctor right away about the reaction and the use of this product.||
0808|085|S|To help prevent low blood sugar, eat meals on a regular schedule,||
0808|086|S|and do not skip meals. Check with your doctor or pharmacist to||
0808|087|S|find out what you should do if you miss a meal.||
0808|088|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0808|089|S|thirst/urination. If these symptoms occur, tell your doctor right||
0808|090|S|away. Your doctor may need to adjust your diabetes medication,||
0808|091|S|exercise program, or diet.||
0808|092|S|   A very serious allergic reaction to this drug is rare.||
0808|093|S|However, get medical help right away if you notice any symptoms||
0808|094|S|of a serious allergic reaction, including: rash, itching/swelling||
0808|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0808|096|S|breathing.||
0808|097|S|   This is not a complete list of possible side effects. If you||
0808|098|S|notice other effects not listed above, contact your doctor or||
0808|099|S|pharmacist.||
0808|100|S|   In the US -||
0808|101|S|   Call your doctor for medical advice about side effects. You||
0808|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0808|103|S|www.fda.gov/medwatch.||
0808|104|S|   In Canada - Call your doctor for medical advice about side||
0808|105|S|effects. You may report side effects to Health Canada at||
0808|106|S|1-866-234-2345.||
0808|107|B|||
0808|108|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0808|109|P|pharmacist if you are allergic to pioglitazone or glimepiride; or||
0808|110|P|to other "glitazones" (such as rosiglitazone); or to other||
0808|111|P|sulfonylureas (such as glipizide, tolbutamide); or if you have||
0808|112|P|any other allergies. This product may contain inactive||
0808|113|P|ingredients, which can cause allergic reactions or other||
0808|114|P|problems. Talk to your pharmacist for more details.||
0808|115|P|   Before taking this medication, tell your doctor or pharmacist||
0808|116|P|your medical history, especially of: heart problems (such as||
0808|117|P|heart failure), fluid in your lungs, swelling (edema, fluid||
0808|118|P|retention), liver problems, kidney disease, thyroid problems,||
0808|119|P|certain hormonal conditions (adrenal/pituitary insufficiency,||
0808|120|P|syndrome of inappropriate secretion of antidiuretic||
0808|121|P|hormone-SIADH), mineral imbalance (hyponatremia), anemia, eye||
0808|122|P|(retina) problems, bladder cancer.||
0808|123|P|   You may experience blurred vision, dizziness, or drowsiness||
0808|124|P|due to extremely low or high blood sugar. Do not drive, use||
0808|125|P|machinery, or do anything that needs alertness or clear vision||
0808|126|P|until you can do it safely.||
0808|127|P|   Limit alcohol while taking this medication because it can||
0808|128|P|increase your risk of developing low blood sugar (hypoglycemia).||
0808|129|P|   It may be harder to control your blood sugar when your body is||
0808|130|P|stressed (such as due to fever, infection, injury, or surgery).||
0808|131|P|In these cases, consult your doctor because you may require a||
0808|132|P|change in your treatment plan, medications, or blood sugar||
0808|133|P|testing.||
0808|134|P|   This medication may make you more sensitive to the sun. Limit||
0808|135|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0808|136|P|sunscreen and wear protective clothing when outdoors. Tell your||
0808|137|P|doctor right away if you get sunburned or have skin||
0808|138|P|blisters/redness.||
0808|139|P|   This medication may increase the risk of bone fracture (such||
0808|140|P|as upper arm, hand, foot, ankle) in female patients. To lower the||
0808|141|P|chance of getting injured, use caution when doing activities such||
0808|142|P|as contact sports.||
0808|143|P|   Older adults maybe at greater risk for low blood sugar while||
0808|144|P|using this drug.||
0808|145|P|   This medication can cause changes in the menstrual cycle||
0808|146|P|(promote ovulation) and increase the risk of becoming pregnant.||
0808|147|P|Consult your doctor or pharmacist about the use of reliable birth||
0808|148|P|control while using this medication.||
0808|149|P|   During pregnancy, this medication should be used only when||
0808|150|P|clearly needed. Discuss the risks and benefits with your doctor.||
0808|151|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
0808|152|P|your doctor for managing your blood sugar while pregnant. Your||
0808|153|P|doctor may change your diabetes treatment during your pregnancy||
0808|154|P|(such as diet and medications including insulin).||
0808|155|P|   It is unknown if this medication passes into breast milk.||
0808|156|P|Because of the possible risk to the infant, breastfeeding is not||
0808|157|P|recommended while using this medication. Consult your doctor||
0808|158|P|before breastfeeding.||
0808|159|B|||
0808|160|I|DRUG INTERACTIONS:  See also How to Use section.||
0808|161|I|   Drug interactions may change how your medications work or||
0808|162|I|increase your risk for serious side effects. This document does||
0808|163|I|not contain all possible drug interactions. Keep a list of all||
0808|164|I|the products you use (including prescription/nonprescription||
0808|165|I|drugs and herbal products) and share it with your doctor and||
0808|166|I|pharmacist. Do not start, stop, or change the dosage of any||
0808|167|I|medicines without your doctor's approval.||
0808|168|I|   Other medications can affect the removal of pioglitazone from||
0808|169|I|your body, which may affect how pioglitazone works. Examples||
0808|170|I|include gemfibrozil, rifamycins including rifampin, among others.||
0808|171|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0808|172|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0808|173|I|heartbeat you would usually feel when your blood sugar falls too||
0808|174|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0808|175|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0808|176|I|   Many drugs can affect your blood sugar, making it harder to||
0808|177|I|control. Before you start, stop, or change any medication, talk||
0808|178|I|with your doctor or pharmacist about how the medication may||
0808|179|I|affect your blood sugar. Check your blood sugar regularly as||
0808|180|I|directed and share the results with your doctor. Tell your doctor||
0808|181|I|right away if you have symptoms of high or low blood sugar. (See||
0808|182|I|also Side Effects section.) Your doctor may need to adjust your||
0808|183|I|diabetes medication, exercise program, or diet.||
0808|184|B|||
0808|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0808|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0808|187|O|poison control center right away. US residents can call||
0808|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0808|189|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
0808|190|O|sweating, loss of consciousness.||
0808|191|B|||
0808|192|N|NOTES:  Do not share this medication with others.||
0808|193|N|   Attend a diabetes education program to learn more about how to||
0808|194|N|manage your diabetes with medications, diet, exercise, and||
0808|195|N|regular medical exams.||
0808|196|N|   Lifestyle changes that help promote healthy bones include||
0808|197|N|increasing weight-bearing exercise, eating well-balanced meals||
0808|198|N|containing adequate calcium and vitamin D, stopping smoking, and||
0808|199|N|limiting alcohol. Consult your doctor to see if you need to take||
0808|200|N|calcium/vitamin D supplements and discuss lifestyle changes that||
0808|201|N|might benefit you.||
0808|202|N|   Lab and/or medical tests (such as kidney/liver function,||
0808|203|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
0808|204|N|should be done while you are taking this medication. Keep all||
0808|205|N|medical and lab appointments. Check your blood sugar regularly as||
0808|206|N|directed and share the results with your doctor.||
0808|207|B|||
0808|208|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
0808|209|D|you remember. If it is near the time of the next dose, skip the||
0808|210|D|missed dose. Take your next dose at the regular time. Do not||
0808|211|D|double the dose to catch up.||
0808|212|B|||
0808|213|R|STORAGE:  Store at room temperature away from light and moisture.||
0808|214|R|Do not store in the bathroom. Keep all medications away from||
0808|215|R|children and pets.||
0808|216|R|   Do not flush medications down the toilet or pour them into a||
0808|217|R|drain unless instructed to do so. Properly discard this product||
0808|218|R|when it is expired or no longer needed. Consult your pharmacist||
0808|219|R|or local waste disposal company.||
0808|220|B|||
0808|221|M|MEDICAL ALERT:  Your condition can cause complications in a||
0808|222|M|medical emergency. For information about enrolling in MedicAlert,||
0808|223|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0808|224|B|||
0808|225|A|Information last revised November 2025.||
0808|226|A|Copyright(c) 2025 First Databank, Inc.||
0808|227|B|||
0809|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0809|002|Z|does NOT have all possible information about this product. This||
0809|003|Z|information does not assure that this product is safe, effective,||
0809|004|Z|or appropriate for you. This information is not individual||
0809|005|Z|medical advice and does not substitute for the advice of your||
0809|006|Z|health care professional. Always ask your health care||
0809|007|Z|professional for complete information about this product and your||
0809|008|Z|specific health needs.||
0809|009|B|||
0809|010|T|CEFTRIAXONE - INJECTION||
0809|011|F|(SEF-trye-AX-one)||
0809|012|B|||
0809|013|C|COMMON BRAND NAME(S): Rocephin||
0809|014|B|||
0809|015|U|USES:  Ceftriaxone is used to treat a wide variety of bacterial||
0809|016|U|infections. This medication belongs to a class of drugs known as||
0809|017|U|cephalosporin antibiotics. It works by stopping the growth of||
0809|018|U|bacteria.||
0809|019|U|   This drug is not recommended for use in newborns with high||
0809|020|U|blood bilirubin levels and premature infants due to increased||
0809|021|U|risk of side effects. Ask the doctor or pharmacist for details.||
0809|022|B|||
0809|023|V|OTHER USES:  This section contains uses of this drug that are not||
0809|024|V|listed in the approved professional labeling for the drug but||
0809|025|V|that may be prescribed by your health care professional. Use this||
0809|026|V|drug for a condition that is listed in this section only if it||
0809|027|V|has been so prescribed by your health care professional.||
0809|028|V|   This drug may also be used before dental procedures in people||
0809|029|V|with certain heart conditions (such as artificial heart valves)||
0809|030|V|to reduce the risk of a serious infection of the heart (bacterial||
0809|031|V|endocarditis).||
0809|032|B|||
0809|033|H|HOW TO USE:  This medication is given by injection into a muscle||
0809|034|H|or vein as directed by your doctor, usually once or twice daily.||
0809|035|H|The dosage is based on your medical condition and response to||
0809|036|H|treatment. Drink plenty of fluids while using this medication||
0809|037|H|unless your doctor directs you otherwise.||
0809|038|H|   If you are using this medication at home, learn all||
0809|039|H|preparation and usage instructions from your health care||
0809|040|H|professional. Avoid mixing ceftriaxone with IV fluids that have||
0809|041|H|calcium in them (such as Ringer's solution, Hartmann's solution,||
0809|042|H|parenteral nutrition-TPN/PPN). Consult your pharmacist for||
0809|043|H|details about the safe use of IV calcium products in infants,||
0809|044|H|children, and adults (see Precautions section). Before using,||
0809|045|H|check this product for particles or discoloration. If either is||
0809|046|H|present, do not use the liquid. Learn how to store and discard||
0809|047|H|medical supplies safely.||
0809|048|H|   For the best effect, use this antibiotic at evenly spaced||
0809|049|H|times. To help you remember, use this medication at the same||
0809|050|H|time(s) every day.||
0809|051|H|   Continue to use this medication for the full time prescribed,||
0809|052|H|even if symptoms disappear after a few days. Stopping the||
0809|053|H|medication too early may result in a return of the infection.||
0809|054|H|   Tell your doctor if your condition lasts or gets worse.||
0809|055|B|||
0809|056|S|SIDE EFFECTS:  Swelling, redness, or pain at the injection site||
0809|057|S|may occur. If any of these effects last or get worse, tell your||
0809|058|S|doctor or pharmacist promptly.||
0809|059|S|   Remember that this medication has been prescribed because your||
0809|060|S|doctor has judged that the benefit to you is greater than the||
0809|061|S|risk of side effects. Many people using this medication do not||
0809|062|S|have serious side effects.||
0809|063|S|   Tell your doctor right away if you have any serious side||
0809|064|S|effects, including: easy bruising/bleeding, unusual tiredness,||
0809|065|S|symptoms of gallbladder disease (such as stomach/abdominal pain,||
0809|066|S|nausea, vomiting), signs of kidney problems (such as change in||
0809|067|S|the amount of urine), pink/bloody/dark urine, painful/frequent||
0809|068|S|urination, back/side pain, yellowing eyes/skin, uncontrollable||
0809|069|S|movements, confusion, seizures.||
0809|070|S|   This medication may rarely cause a severe intestinal condition||
0809|071|S|due to a bacteria called C. difficile. This condition may occur||
0809|072|S|during treatment or weeks to months after treatment has stopped.||
0809|073|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0809|074|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0809|075|S|stool.||
0809|076|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0809|077|S|products because they may make symptoms worse.||
0809|078|S|   Use of this medication for prolonged or repeated periods may||
0809|079|S|result in oral thrush or a new yeast infection. Contact your||
0809|080|S|doctor if you notice white patches in your mouth, a change in||
0809|081|S|vaginal discharge, or other new symptoms.||
0809|082|S|   If ceftriaxone is mixed with a numbing medication (such as||
0809|083|S|lidocaine) before injection into a muscle, it may rarely cause a||
0809|084|S|serious blood problem (methemoglobinemia). Get medical help right||
0809|085|S|away if you have any very serious side effects, including:||
0809|086|S|pale/gray/blue skin, fast heartbeat, shortness of breath.||
0809|087|S|   A very serious allergic reaction to this drug is rare.||
0809|088|S|However, get medical help right away if you notice any symptoms||
0809|089|S|of a serious allergic reaction, including: rash, itching/swelling||
0809|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0809|091|S|breathing.||
0809|092|S|   This is not a complete list of possible side effects. If you||
0809|093|S|notice other effects not listed above, contact your doctor or||
0809|094|S|pharmacist.||
0809|095|S|   In the US -||
0809|096|S|   Call your doctor for medical advice about side effects. You||
0809|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0809|098|S|www.fda.gov/medwatch.||
0809|099|S|   In Canada - Call your doctor for medical advice about side||
0809|100|S|effects. You may report side effects to Health Canada at||
0809|101|S|1-866-234-2345.||
0809|102|B|||
0809|103|P|PRECAUTIONS:  Before using ceftriaxone, tell your doctor or||
0809|104|P|pharmacist if you are allergic to it; or to other antibiotics||
0809|105|P|(such as penicillins, other cephalosporins); or if you have any||
0809|106|P|other allergies. This product may contain inactive ingredients,||
0809|107|P|which can cause allergic reactions or other problems. Talk to||
0809|108|P|your pharmacist for more details.||
0809|109|P|   Before using this medication, tell your doctor or pharmacist||
0809|110|P|your medical history, especially of: gallbladder disease, kidney||
0809|111|P|disease, liver disease, stomach/intestinal diseases (such as||
0809|112|P|colitis).||
0809|113|P|   Do not give any products by vein that contain calcium||
0809|114|P|(including IV solutions such as Ringer's solution, Hartmann's||
0809|115|P|solution, parenteral nutrition-TPN/PPN) to a newborn less than 1||
0809|116|P|month old who is receiving this medication. Doing so can cause||
0809|117|P|serious problems in the vital organs.||
0809|118|P|   Ceftriaxone may cause live bacterial vaccines (such as typhoid||
0809|119|P|vaccine) to not work well. Tell your health care professional||
0809|120|P|that you are using ceftriaxone before having any||
0809|121|P|immunizations/vaccinations.||
0809|122|P|   Before having surgery, tell your doctor or dentist about all||
0809|123|P|the products you use (including prescription drugs,||
0809|124|P|nonprescription drugs, and herbal products).||
0809|125|P|   Tell your doctor if you are pregnant before using this||
0809|126|P|medication.||
0809|127|P|   This medication passes into breast milk in small amounts and||
0809|128|P|is unlikely to harm a nursing infant. Consult your doctor before||
0809|129|P|breastfeeding.||
0809|130|B|||
0809|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0809|132|I|medications work or increase your risk for serious side effects.||
0809|133|I|This document does not contain all possible drug interactions.||
0809|134|I|Keep a list of all the products you use (including||
0809|135|I|prescription/nonprescription drugs and herbal products) and share||
0809|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
0809|137|I|the dosage of any medicines without your doctor's approval.||
0809|138|I|   Some products that may interact with this drug include:||
0809|139|I|calcium-containing IV fluids.||
0809|140|I|   This medication may interfere with certain lab tests (such as||
0809|141|I|certain urine glucose tests), possibly causing false test||
0809|142|I|results. Make sure lab personnel and all your doctors know you||
0809|143|I|use this drug.||
0809|144|B|||
0809|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0809|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0809|147|O|poison control center right away. US residents can call||
0809|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0809|149|O|Symptoms of overdose may include: seizures.||
0809|150|B|||
0809|151|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0809|152|N|kidney function) should be done while you are using this||
0809|153|N|medication. Keep all medical and lab appointments.||
0809|154|B|||
0809|155|D|MISSED DOSE:  It is important to get each dose of this medication||
0809|156|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0809|157|D|right away for a new dosing schedule. Do not double the dose to||
0809|158|D|catch up.||
0809|159|B|||
0809|160|R|STORAGE:  Consult the product instructions and your pharmacist||
0809|161|R|for storage details. Keep all medications away from children and||
0809|162|R|pets.||
0809|163|R|   Do not flush medications down the toilet or pour them into a||
0809|164|R|drain unless instructed to do so. Properly discard this product||
0809|165|R|when it is expired or no longer needed. Consult your pharmacist||
0809|166|R|or local waste disposal company.||
0809|167|B|||
0809|168|A|Information last revised January 2025.||
0809|169|A|Copyright(c) 2025 First Databank, Inc.||
0809|170|B|||
0811|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0811|002|Z|does NOT have all possible information about this product. This||
0811|003|Z|information does not assure that this product is safe, effective,||
0811|004|Z|or appropriate for you. This information is not individual||
0811|005|Z|medical advice and does not substitute for the advice of your||
0811|006|Z|health care professional. Always ask your health care||
0811|007|Z|professional for complete information about this product and your||
0811|008|Z|specific health needs.||
0811|009|B|||
0811|010|T|DROSPIRENONE/ESTRADIOL - ORAL||
0811|011|F|(droh-SPYE-re-none/ess-truh-DYE-all)||
0811|012|B|||
0811|013|C|COMMON BRAND NAME(S): Angeliq||
0811|014|B|||
0811|015|W|WARNING:  Rarely, very serious side effects have occurred when||
0811|016|W|estrogen-only and combination hormone replacement therapies||
0811|017|W|(estrogen and progestin HRT) are used after menopause. Discuss||
0811|018|W|the risks and benefits of hormone treatment and your personal||
0811|019|W|health history with your doctor.||
0811|020|W|   Combination HRT should not be used to prevent heart disease or||
0811|021|W|dementia. Combination HRT may rarely cause serious problems from||
0811|022|W|blood clots (such as heart attack, stroke, blood clots in the||
0811|023|W|lungs or legs), dementia, and breast cancer. The risk for stroke||
0811|024|W|and breast cancer increases with age, especially for women older||
0811|025|W|than 75. Estrogens may also increase the risk of cancer of the||
0811|026|W|ovaries. Some of these risks appear to depend on the length of||
0811|027|W|time this drug is used and the amount of estrogen per dose. This||
0811|028|W|medication should be used for the shortest possible length of||
0811|029|W|time at the lowest effective dose, so you can obtain the benefits||
0811|030|W|and minimize the chance of serious side effects from long-term||
0811|031|W|treatment. Discuss the details with your doctor and check with||
0811|032|W|him/her regularly (such as every 3-6 months) to see if you still||
0811|033|W|need to take this medication.||
0811|034|W|   If you use this drug for an extended time, you should have a||
0811|035|W|complete physical exam at regular intervals (such as once a year)||
0811|036|W|or as directed by your doctor. See Notes section.||
0811|037|B|||
0811|038|U|USES:  This medication is used to reduce menopause symptoms. It||
0811|039|U|helps reduce episodes of flushing and sweating of the upper body||
0811|040|U|and face, commonly called hot flashes. It also helps treat||
0811|041|U|dryness, itching, and burning around the vagina. These symptoms||
0811|042|U|occur when a woman's body no longer makes the usual amount of||
0811|043|U|estrogen. This medication is a combination of 2 types of||
0811|044|U|hormones: an estrogen (estradiol) and a progestin (drospirenone).||
0811|045|U|A progestin is added to estrogen replacement therapy to reduce||
0811|046|U|the risk of cancer of the uterus. A woman who has had her uterus||
0811|047|U|removed does not need progestin and should not be treated with||
0811|048|U|this combination medication.||
0811|049|U|   If you need treatment only for vaginal menopause symptoms,||
0811|050|U|products applied directly inside the vagina should be considered||
0811|051|U|before medications that are taken by mouth, absorbed through the||
0811|052|U|skin, or injected.||
0811|053|B|||
0811|054|V|OTHER USES:  This section contains uses of this drug that are not||
0811|055|V|listed in the approved professional labeling for the drug but||
0811|056|V|that may be prescribed by your health care professional. Use this||
0811|057|V|drug for a condition that is listed in this section only if it||
0811|058|V|has been so prescribed by your health care professional.||
0811|059|V|   Certain combination HRT products may also be prescribed for||
0811|060|V|bone loss (osteoporosis) in people at high risk who cannot take||
0811|061|V|other drugs that are safe and effective to prevent or treat bone||
0811|062|V|loss (such as raloxifene, bisphosphonates such as alendronate).||
0811|063|V|These medicines should be considered for use before||
0811|064|V|estrogen/progestin HRT therapy for osteoporosis.||
0811|065|B|||
0811|066|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0811|067|H|from your pharmacist before you start using this medication and||
0811|068|H|each time you get a refill. If you have any questions, ask your||
0811|069|H|doctor or pharmacist.||
0811|070|H|   Take this medication by mouth as directed by your doctor,||
0811|071|H|usually once daily. Take this medication regularly to get the||
0811|072|H|most benefit from it. To help you remember, take it at the same||
0811|073|H|time each day.||
0811|074|H|   Tell your doctor if your condition does not get better or if||
0811|075|H|it gets worse.||
0811|076|B|||
0811|077|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, stomach||
0811|078|S|upset, bloating, irritability, changes in sleep patterns, nausea,||
0811|079|S|weight changes, increased/decreased interest in sex, change in||
0811|080|S|vaginal discharge, or breast tenderness may occur. If any of||
0811|081|S|these effects last or get worse, tell your doctor or pharmacist||
0811|082|S|promptly.||
0811|083|S|   Remember that this medication has been prescribed because your||
0811|084|S|doctor has judged that the benefit to you is greater than the||
0811|085|S|risk of side effects. Many people using this medication do not||
0811|086|S|have serious side effects.||
0811|087|S|   Tell your doctor right away if you have any serious side||
0811|088|S|effects, including: mental/mood changes (such as depression,||
0811|089|S|memory loss), breast lumps, nipple discharge, swelling of the||
0811|090|S|hands/feet, unusual vaginal bleeding (such as spotting,||
0811|091|S|breakthrough bleeding, prolonged/returning bleeding), yellowing||
0811|092|S|eyes/skin, stomach/abdominal pain, worsening of a seizure||
0811|093|S|condition, muscle weakness, signs of worsening diabetes control||
0811|094|S|(such as increased thirst and urination), symptoms of a high||
0811|095|S|potassium blood level (such as muscle weakness, slow/irregular||
0811|096|S|heartbeat).||
0811|097|S|   This medication may rarely cause serious (sometimes fatal)||
0811|098|S|problems from blood clots (such as heart attack, stroke, blood||
0811|099|S|clots in the lungs or legs). Get medical help right away if you||
0811|100|S|have: pain/swelling/warmth in the groin/calf, shortness of||
0811|101|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
0811|102|S|sweating, sudden dizziness/fainting, confusion, trouble speaking,||
0811|103|S|weakness on one side of the body, sudden vision changes,||
0811|104|S|sudden/severe headaches.||
0811|105|S|   A very serious allergic reaction to this drug is rare.||
0811|106|S|However, get medical help right away if you notice any symptoms||
0811|107|S|of a serious allergic reaction, including: rash, itching/swelling||
0811|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0811|109|S|breathing.||
0811|110|S|   This is not a complete list of possible side effects. If you||
0811|111|S|notice other effects not listed above, contact your doctor or||
0811|112|S|pharmacist.||
0811|113|S|   In the US -||
0811|114|S|   Call your doctor for medical advice about side effects. You||
0811|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0811|116|S|www.fda.gov/medwatch.||
0811|117|S|   In Canada - Call your doctor for medical advice about side||
0811|118|S|effects. You may report side effects to Health Canada at||
0811|119|S|1-866-234-2345.||
0811|120|B|||
0811|121|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0811|122|P|pharmacist if you are allergic to drospirenone or estradiol; or||
0811|123|P|to spironolactone; or if you have any other allergies. This||
0811|124|P|product may contain inactive ingredients, which can cause||
0811|125|P|allergic reactions or other problems. Talk to your pharmacist for||
0811|126|P|more details.||
0811|127|P|   Before using this medication, tell your doctor or pharmacist||
0811|128|P|your medical history, especially of: vaginal bleeding of unknown||
0811|129|P|cause, certain types of cancer (breast, ovary, uterus), blood||
0811|130|P|clotting disorders (such as protein C or protein S deficiency),||
0811|131|P|current/history of blood clots (such as in the legs, eyes,||
0811|132|P|lungs), stroke, liver disease, kidney disease, adrenal gland||
0811|133|P|problems, family medical history (including blood clots, breast||
0811|134|P|lumps/cancer), family or personal history of a certain swelling||
0811|135|P|disorder (angioedema), asthma, diabetes, seizures, migraine||
0811|136|P|headaches, heart disease (such as high blood pressure, heart||
0811|137|P|failure, heart attack), underactive thyroid (hypothyroidism), a||
0811|138|P|certain hormone problem (hypoparathyroidism), mineral imbalance||
0811|139|P|(high or low calcium blood level, high potassium blood level, low||
0811|140|P|sodium blood level), mental/mood disorders (such as depression,||
0811|141|P|memory loss), high blood pressure during pregnancy (toxemia),||
0811|142|P|yellowing eyes/skin (cholestatic jaundice) during pregnancy or||
0811|143|P|with past estrogen use, uterus problems (such as uterine||
0811|144|P|fibroids, endometriosis), high blood cholesterol/fat||
0811|145|P|(triglyceride) levels, gallbladder disease, obesity, a certain||
0811|146|P|metabolic disorder (porphyria), lupus.||
0811|147|P|   This drug may make you dizzy or lightheaded. Alcohol or||
0811|148|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
0811|149|P|machinery, or do anything that needs alertness until you can do||
0811|150|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0811|151|P|are using marijuana (cannabis).||
0811|152|P|   This product may increase your potassium levels. Before using||
0811|153|P|potassium supplements or salt substitutes that contain potassium,||
0811|154|P|consult your doctor or pharmacist.||
0811|155|P|   If you are nearsighted or wear contact lenses, you may develop||
0811|156|P|vision problems or trouble wearing your contact lenses. Consult||
0811|157|P|your eye doctor if these problems occur.||
0811|158|P|   This medication may cause blotchy, dark areas on your face and||
0811|159|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0811|160|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0811|161|P|wear protective clothing when outdoors.||
0811|162|P|   Do not smoke cigarettes or use tobacco. Smoking/using tobacco||
0811|163|P|while taking this medication further increase your risk for||
0811|164|P|stroke, blood clots, high blood pressure, and heart attacks,||
0811|165|P|especially in women older than 35.||
0811|166|P|   If you will be having surgery or will be confined to a chair||
0811|167|P|or bed for a long time (such as on a long plane flight), tell||
0811|168|P|your doctor beforehand. Special precautions may need to be taken||
0811|169|P|in these circumstances while you are taking this drug because of||
0811|170|P|the increased risk for blood clots.||
0811|171|P|   This medication should not be used during pregnancy. If you||
0811|172|P|become pregnant or think you may be pregnant, tell your doctor||
0811|173|P|right away.||
0811|174|P|   This medication is not effective for preventing a miscarriage||
0811|175|P|and should not be used for this purpose.||
0811|176|P|   This medication passes into breast milk. Consult your doctor||
0811|177|P|before breastfeeding.||
0811|178|B|||
0811|179|I|DRUG INTERACTIONS:  See also Precautions section.||
0811|180|I|   Drug interactions may change how your medications work or||
0811|181|I|increase your risk for serious side effects. This document does||
0811|182|I|not contain all possible drug interactions. Keep a list of all||
0811|183|I|the products you use (including prescription/nonprescription||
0811|184|I|drugs and herbal products) and share it with your doctor and||
0811|185|I|pharmacist. Do not start, stop, or change the dosage of any||
0811|186|I|medicines without your doctor's approval.||
0811|187|I|   Some products that may interact with this drug are: aromatase||
0811|188|I|inhibitors (such as anastrozole, exemestane),||
0811|189|I|atazanavir/cobicistat, corticosteroids (such as prednisone),||
0811|190|I|fezolinetant, ospemifene, raloxifene, tamoxifen, tizanidine,||
0811|191|I|tranexamic acid, warfarin.||
0811|192|I|   Drospirenone may raise your potassium blood level. Tell your||
0811|193|I|doctor if you are regularly taking other drugs/products that can||
0811|194|I|also raise your potassium level (including aliskiren, ACE||
0811|195|I|inhibitors such as enalapril/lisinopril, angiotensin receptor||
0811|196|I|blockers such as losartan/valsartan, heparin, NSAIDs such as||
0811|197|I|ibuprofen/naproxen, potassium-sparing "water pills"/diuretics||
0811|198|I|such as eplerenone/spironolactone/triamterene).||
0811|199|I|   Other medications can affect the removal of estrogen from your||
0811|200|I|body, which may affect how estrogen works. Examples include azole||
0811|201|I|antifungals (such as itraconazole), macrolide antibiotics (such||
0811|202|I|as erythromycin), rifamycins (such as rifabutin), St. John's||
0811|203|I|wort, drugs used to treat seizures (such as carbamazepine,||
0811|204|I|phenytoin), among others.||
0811|205|I|   This medication may interfere with certain lab tests, possibly||
0811|206|I|causing false test results. Make sure lab personnel and all your||
0811|207|I|doctors know you use this drug.||
0811|208|B|||
0811|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0811|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0811|211|O|poison control center right away. US residents can call||
0811|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0811|213|O|Symptoms of overdose may include: severe nausea/vomiting, unusual||
0811|214|O|vaginal bleeding in females.||
0811|215|B|||
0811|216|N|NOTES:  Do not share this medication with others. Regular||
0811|217|N|complete physical exams which include lab and/or medical tests||
0811|218|N|(such as blood pressure, breast exam/mammogram, pelvic exam, Pap||
0811|219|N|smear) should be done while you are taking this medication.||
0811|220|N|Follow your doctor's instructions for examining your breasts, and||
0811|221|N|report any lumps right away. Keep all medical and lab||
0811|222|N|appointments. Consult your doctor for more details.||
0811|223|N|   Lifestyle changes that help promote healthy bones include||
0811|224|N|increasing weight-bearing exercise, stopping smoking, limiting||
0811|225|N|alcohol, and eating well-balanced meals that contain adequate||
0811|226|N|calcium and vitamin D. Since you may also need to take calcium||
0811|227|N|and vitamin D supplements and make lifestyle changes, consult||
0811|228|N|your doctor for specific advice.||
0811|229|N|   Additional lifestyle changes (such as reducing stress, eating||
0811|230|N|a low fat/low salt diet, losing weight if you are overweight) to||
0811|231|N|control or prevent high blood pressure, high cholesterol, and||
0811|232|N|diabetes help to prevent heart disease and strokes. Keep your||
0811|233|N|mind active with mental exercises to help prevent dementia.||
0811|234|N|Discuss with your doctor lifestyle changes that might benefit||
0811|235|N|you.||
0811|236|N|   You can also manage hot flashes by keeping a cool body||
0811|237|N|temperature (such as by using a fan, drinking cool beverages,||
0811|238|N|dressing lightly/in layers, avoiding hot/spicy foods). Limiting||
0811|239|N|caffeine and alcohol, exercising regularly, and learning||
0811|240|N|relaxation techniques may help reduce hot flashes. Vaginal||
0811|241|N|lubricants can help lessen discomfort during intercourse.||
0811|242|B|||
0811|243|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0811|244|D|remember. If it is near the time of the next dose, skip the||
0811|245|D|missed dose. Take your next dose at the regular time. Do not||
0811|246|D|double the dose to catch up.||
0811|247|B|||
0811|248|R|STORAGE:  Store at room temperature away from light and moisture.||
0811|249|R|Do not store in the bathroom. Keep all medications away from||
0811|250|R|children and pets.||
0811|251|R|   Do not flush medications down the toilet or pour them into a||
0811|252|R|drain unless instructed to do so. Properly discard this product||
0811|253|R|when it is expired or no longer needed. Consult your pharmacist||
0811|254|R|or local waste disposal company.||
0811|255|B|||
0811|256|A|Information last revised October 2024.||
0811|257|A|Copyright(c) 2025 First Databank, Inc.||
0811|258|B|||
0814|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0814|002|Z|does NOT have all possible information about this product. This||
0814|003|Z|information does not assure that this product is safe, effective,||
0814|004|Z|or appropriate for you. This information is not individual||
0814|005|Z|medical advice and does not substitute for the advice of your||
0814|006|Z|health care professional. Always ask your health care||
0814|007|Z|professional for complete information about this product and your||
0814|008|Z|specific health needs.||
0814|009|B|||
0814|010|T|KETOCONAZOLE 2% GEL - TOPICAL||
0814|011|F|(kee-toe-CON-uh-zole)||
0814|012|B|||
0814|013|C|COMMON BRAND NAME(S): Xolegel||
0814|014|B|||
0814|015|U|USES:  This medication is used to treat a certain skin condition||
0814|016|U|(seborrheic dermatitis, a type of dandruff). In this condition,||
0814|017|U|it is believed that a fungus (Malassezia furfur) infects the skin||
0814|018|U|or scalp, resulting in dry, flaky skin (scales) on the scalp,||
0814|019|U|face, ears, chest, or upper back. Ketoconazole is an azole||
0814|020|U|antifungal drug that works by stopping the growth of fungus.||
0814|021|B|||
0814|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0814|023|H|from your pharmacist before you start using ketoconazole and each||
0814|024|H|time you get a refill. If you have any questions, ask your doctor||
0814|025|H|or pharmacist.||
0814|026|H|   Use this medication on the scalp and skin only. Clean and||
0814|027|H|thoroughly dry the area to be treated. Wash hands before and||
0814|028|H|after applying this medication. Apply it to the affected skin and||
0814|029|H|also to a small amount of the normal skin next to this area as||
0814|030|H|directed by your doctor, usually once a day. Length of treatment||
0814|031|H|depends on the response to treatment and is usually for 2 weeks.||
0814|032|H|Do not apply this more often than prescribed. Your condition will||
0814|033|H|not clear faster, but side effects may be increased.||
0814|034|H|   Do not get this medication in the eyes, nose, or mouth. If||
0814|035|H|this occurs, flush with plenty of water. If irritation occurs,||
0814|036|H|contact your doctor right away.||
0814|037|H|   Use this medication regularly to get the most benefit from it.||
0814|038|H|To help you remember, use it at the same time each day.||
0814|039|H|   Do not wash the treated area for at least 3 hours after||
0814|040|H|applying this medication. Wait at least 20 minutes before||
0814|041|H|applying makeup or sunscreen to the treated skin.||
0814|042|H|   Tell your doctor if your condition lasts or gets worse after 2||
0814|043|H|weeks.||
0814|044|B|||
0814|045|S|SIDE EFFECTS:  Burning, redness, or dryness of the treated skin||
0814|046|S|may occur. If any of these effects last or get worse, tell your||
0814|047|S|doctor or pharmacist promptly.||
0814|048|S|   Remember that this medication has been prescribed because your||
0814|049|S|doctor has judged that the benefit to you is greater than the||
0814|050|S|risk of side effects. Many people using this medication do not||
0814|051|S|have serious side effects.||
0814|052|S|   Tell your doctor right away if you have any serious side||
0814|053|S|effects, including: blisters/open sores on the treated skin, eye||
0814|054|S|swelling.||
0814|055|S|   A very serious allergic reaction to this drug is rare.||
0814|056|S|However, get medical help right away if you notice any symptoms||
0814|057|S|of a serious allergic reaction, including: rash, itching/swelling||
0814|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0814|059|S|breathing.||
0814|060|S|   This is not a complete list of possible side effects. If you||
0814|061|S|notice other effects not listed above, contact your doctor or||
0814|062|S|pharmacist.||
0814|063|S|   In the US -||
0814|064|S|   Call your doctor for medical advice about side effects. You||
0814|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0814|066|S|www.fda.gov/medwatch.||
0814|067|S|   In Canada - Call your doctor for medical advice about side||
0814|068|S|effects. You may report side effects to Health Canada at||
0814|069|S|1-866-234-2345.||
0814|070|B|||
0814|071|P|PRECAUTIONS:  Before using ketoconazole, tell your doctor or||
0814|072|P|pharmacist if you are allergic to it; or to other azole||
0814|073|P|antifungals such as clotrimazole, econazole, or miconazole; or if||
0814|074|P|you have any other allergies. This product may contain inactive||
0814|075|P|ingredients, which can cause allergic reactions or other||
0814|076|P|problems. Talk to your pharmacist for more details.||
0814|077|P|   Before using this medication, tell your doctor or pharmacist||
0814|078|P|your medical history.||
0814|079|P|   During pregnancy, this medication should be used only when||
0814|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
0814|081|P|   It is unknown if this drug passes into breast milk. Consult||
0814|082|P|your doctor before breastfeeding.||
0814|083|B|||
0814|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0814|085|I|medications work or increase your risk for serious side effects.||
0814|086|I|This document does not contain all possible drug interactions.||
0814|087|I|Keep a list of all the products you use (including||
0814|088|I|prescription/nonprescription drugs and herbal products) and share||
0814|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
0814|090|I|the dosage of any medicines without your doctor's approval.||
0814|091|B|||
0814|092|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0814|093|O|has overdosed and has serious symptoms such as passing out or||
0814|094|O|trouble breathing, call 911. Otherwise, call a poison control||
0814|095|O|center right away. US residents can call 1-800-222-1222. Canada||
0814|096|O|residents can call 1-844-764-7669.||
0814|097|B|||
0814|098|N|NOTES:  Do not share this medication with others.||
0814|099|N|   This medication has been prescribed for your current condition||
0814|100|N|only. Do not use it later for another skin condition unless told||
0814|101|N|to do so by your doctor. A different medication may be necessary||
0814|102|N|in that case.||
0814|103|B|||
0814|104|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0814|105|D|If it is near the time of the next dose, skip the missed dose.||
0814|106|D|Use your next dose at the regular time. Do not double the dose to||
0814|107|D|catch up.||
0814|108|B|||
0814|109|R|STORAGE:  Store at room temperature. This product is flammable.||
0814|110|R|Keep it away from heat and open flame. Keep all medications away||
0814|111|R|from children and pets.||
0814|112|R|   Do not flush medications down the toilet or pour them into a||
0814|113|R|drain unless instructed to do so. Properly discard this product||
0814|114|R|when it is expired or no longer needed. Consult your pharmacist||
0814|115|R|or local waste disposal company.||
0814|116|B|||
0814|117|A|Information last revised July 2025.||
0814|118|A|Copyright(c) 2025 First Databank, Inc.||
0814|119|B|||
0815|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0815|002|Z|does NOT have all possible information about this product. This||
0815|003|Z|information does not assure that this product is safe, effective,||
0815|004|Z|or appropriate for you. This information is not individual||
0815|005|Z|medical advice and does not substitute for the advice of your||
0815|006|Z|health care professional. Always ask your health care||
0815|007|Z|professional for complete information about this product and your||
0815|008|Z|specific health needs.||
0815|009|B|||
0815|010|T|UNDECYLENIC ACID - TOPICAL||
0815|011|F|(un-de-sil-EN-ik)||
0815|012|B|||
0815|013|U|USES:  This medication is used to treat skin fungal infections||
0815|014|U|such as athlete's foot and jock itch. Undecylenic acid is a fatty||
0815|015|U|acid that works by preventing the growth of fungus. This product||
0815|016|U|should not be used to treat fungal infections of the scalp or||
0815|017|U|nails.||
0815|018|B|||
0815|019|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0815|020|H|thoroughly dry the area to be treated. Apply this medication to||
0815|021|H|the affected skin, usually twice a day or as directed by your||
0815|022|H|doctor or the product package. The dosage and length of treatment||
0815|023|H|depends on the type of infection being treated.||
0815|024|H|   Apply enough medication to cover the affected area and some of||
0815|025|H|the surrounding skin. After applying this medication, wash your||
0815|026|H|hands. Do not wrap, cover or bandage the area.||
0815|027|H|   Do not apply this medication in the eyes, nose, mouth, or||
0815|028|H|vagina. If this occurs, flush with plenty of water. If irritation||
0815|029|H|occurs, contact your doctor right away.||
0815|030|H|   Use this medication regularly in order to get the most benefit||
0815|031|H|from it. Remember to use it at the same times each day.||
0815|032|H|   Continue to use this medication for the full time as directed,||
0815|033|H|even if symptoms disappear after a few days. Stopping the||
0815|034|H|medication too early may result in a return of the infection.||
0815|035|H|   Tell your doctor if your condition lasts after 2 to 4 weeks or||
0815|036|H|gets worse at any time, or if you think you may have a serious||
0815|037|H|medical problem.||
0815|038|B|||
0815|039|S|SIDE EFFECTS:  Irritation or burning of the treated skin may||
0815|040|S|occur. If any of these effects last or get worse, tell your||
0815|041|S|doctor or pharmacist promptly.||
0815|042|S|   If your doctor has directed you to use this medication,||
0815|043|S|remember that your doctor has judged that the benefit to you is||
0815|044|S|greater than the risk of side effects. Many people using this||
0815|045|S|medication do not have serious side effects.||
0815|046|S|   A very serious allergic reaction to this drug is rare.||
0815|047|S|However, get medical help right away if you notice any symptoms||
0815|048|S|of a serious allergic reaction, including: rash, itching/swelling||
0815|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0815|050|S|breathing.||
0815|051|S|   This is not a complete list of possible side effects. If you||
0815|052|S|notice other effects not listed above, contact your doctor or||
0815|053|S|pharmacist.||
0815|054|S|   In the US -||
0815|055|S|   Call your doctor for medical advice about side effects. You||
0815|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0815|057|S|www.fda.gov/medwatch.||
0815|058|S|   In Canada - Call your doctor for medical advice about side||
0815|059|S|effects. You may report side effects to Health Canada at||
0815|060|S|1-866-234-2345.||
0815|061|B|||
0815|062|P|PRECAUTIONS:  Before using undecylenic acid, tell your doctor or||
0815|063|P|pharmacist if you are allergic to it; or if you have any other||
0815|064|P|allergies. This product may contain inactive ingredients, which||
0815|065|P|can cause allergic reactions or other problems. Talk to your||
0815|066|P|pharmacist for more details.||
0815|067|P|   If you have any health problems, consult your doctor or||
0815|068|P|pharmacist before using this product.||
0815|069|P|   Before having surgery, tell your doctor or dentist about all||
0815|070|P|the products you use (including prescription drugs,||
0815|071|P|nonprescription drugs, and herbal products).||
0815|072|P|   Tell your doctor if you are pregnant before using this||
0815|073|P|medication.||
0815|074|P|   It is unknown if this drug passes into breast milk. Consult||
0815|075|P|your doctor before breastfeeding.||
0815|076|B|||
0815|077|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0815|078|I|medications work or increase your risk for serious side effects.||
0815|079|I|This document does not contain all possible drug interactions.||
0815|080|I|Keep a list of all the products you use (including||
0815|081|I|prescription/nonprescription drugs and herbal products) and share||
0815|082|I|it with your doctor and pharmacist. Do not start, stop, or change||
0815|083|I|the dosage of any medicines without your doctor's approval.||
0815|084|B|||
0815|085|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0815|086|O|has overdosed and has serious symptoms such as passing out or||
0815|087|O|trouble breathing, call 911. Otherwise, call a poison control||
0815|088|O|center right away. US residents can call 1-800-222-1222. Canada||
0815|089|O|residents can call 1-844-764-7669.||
0815|090|B|||
0815|091|N|NOTES:  Do not share this medication with others.||
0815|092|N|   When treating athlete's foot, wear well-ventilated shoes and||
0815|093|N|change socks at least once a day.||
0815|094|B|||
0815|095|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0815|096|D|If it is near the time of the next dose, skip the missed dose.||
0815|097|D|Use your next dose at the regular time. Do not double the dose to||
0815|098|D|catch up.||
0815|099|B|||
0815|100|R|STORAGE:  Refer to the storage information printed on the||
0815|101|R|package. Keep all medications away from children and pets.||
0815|102|R|   Do not flush medications down the toilet or pour them into a||
0815|103|R|drain unless instructed to do so. Properly discard this product||
0815|104|R|when it is expired or no longer needed. Consult your pharmacist||
0815|105|R|or local waste disposal company.||
0815|106|B|||
0815|107|A|Information last revised May 2024.||
0815|108|A|Copyright(c) 2025 First Databank, Inc.||
0815|109|B|||
0819|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0819|002|Z|does NOT have all possible information about this product. This||
0819|003|Z|information does not assure that this product is safe, effective,||
0819|004|Z|or appropriate for you. This information is not individual||
0819|005|Z|medical advice and does not substitute for the advice of your||
0819|006|Z|health care professional. Always ask your health care||
0819|007|Z|professional for complete information about this product and your||
0819|008|Z|specific health needs.||
0819|009|B|||
0819|010|T|MORPHINE - ORAL||
0819|011|F|(MORE-feen)||
0819|012|B|||
0819|013|C|COMMON BRAND NAME(S): MS-IR||
0819|014|B|||
0819|015|W|WARNING:  Morphine has a risk for abuse and addiction, which can||
0819|016|W|lead to overdose and death. Morphine may also cause severe,||
0819|017|W|possibly fatal, breathing problems. To lower your risk, your||
0819|018|W|doctor should have you take the smallest dose of morphine that||
0819|019|W|works, and take it for the shortest possible time. See also How||
0819|020|W|to Use section for more information about addiction.||
0819|021|W|   Ask your doctor or pharmacist if you should have medication||
0819|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0819|023|W|Teach your family or household members about the signs of an||
0819|024|W|opioid overdose and how to treat it.||
0819|025|W|   The risk for severe breathing problems is higher when you||
0819|026|W|start this medication and after a dose increase, or if you take||
0819|027|W|the wrong dose/strength. Taking this medication with alcohol or||
0819|028|W|other drugs that can cause drowsiness or breathing problems may||
0819|029|W|cause very serious side effects, including death. Be sure you||
0819|030|W|know how to take morphine and what other drugs you should avoid||
0819|031|W|taking with it. See also Drug Interactions section. Get medical||
0819|032|W|help right away if any of these very serious side effects occur:||
0819|033|W|slow/shallow breathing, unusual lightheadedness, severe||
0819|034|W|drowsiness/dizziness, difficulty waking up.||
0819|035|W|   The higher strength of morphine liquid (20 milligrams per||
0819|036|W|milliliter) should be used only if you have been regularly taking||
0819|037|W|moderate to large amounts of an opioid pain medication. This||
0819|038|W|strength may cause overdose (even death) if taken by a person who||
0819|039|W|has not been regularly taking opioids. Do not confuse the dose of||
0819|040|W|morphine liquid in milligrams (mg) with the dose in milliliters||
0819|041|W|(mL). (See also How to Use section.)||
0819|042|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0819|043|W|or abuse. If someone accidentally swallows this drug, get medical||
0819|044|W|help right away.||
0819|045|W|   Before using this medication, women of childbearing age should||
0819|046|W|talk with their doctor(s) about the risks and benefits. Tell your||
0819|047|W|doctor if you are pregnant or if you plan to become pregnant.||
0819|048|W|During pregnancy, this medication should be used only when||
0819|049|W|clearly needed. It may slightly increase the risk of birth||
0819|050|W|defects if used during the first two months of pregnancy. Also,||
0819|051|W|using it for a long time or in high doses near the expected||
0819|052|W|delivery date may harm the unborn baby. To lessen the risk, take||
0819|053|W|the smallest effective dose for the shortest possible time.||
0819|054|W|Babies born to mothers who use this drug for a long time may||
0819|055|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0819|056|W|doctor right away if you notice any symptoms in your newborn baby||
0819|057|W|such as crying that doesn't stop, slow/shallow breathing,||
0819|058|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0819|059|W|difficulty gaining weight.||
0819|060|B|||
0819|061|U|USES:  This medication is used to help relieve moderate to severe||
0819|062|U|pain. Morphine belongs to a class of drugs known as opioid||
0819|063|U|analgesics. It works in the brain to change how your body feels||
0819|064|U|and responds to pain.||
0819|065|B|||
0819|066|H|HOW TO USE:  Read the Medication Guide provided by your||
0819|067|H|pharmacist before you start taking morphine and each time you get||
0819|068|H|a refill. If you have any questions, ask your doctor or||
0819|069|H|pharmacist.||
0819|070|H|   Take this medication by mouth as directed by your doctor. You||
0819|071|H|may take this drug with or without food. If you have nausea, it||
0819|072|H|may help to take this drug with food. Ask your doctor or||
0819|073|H|pharmacist about other ways to decrease nausea (such as lying||
0819|074|H|down for 1 to 2 hours with as little head movement as possible).||
0819|075|H|   If you are using the liquid form of this medication, carefully||
0819|076|H|measure the dose using a special measuring device/spoon. Do not||
0819|077|H|use a household spoon because you may not get the correct dose.||
0819|078|H|Ask your pharmacist or doctor if you are not sure how to check or||
0819|079|H|measure the dose.||
0819|080|H|   The dosage is based on your medical condition and response to||
0819|081|H|treatment. Do not increase your dose, take the medication more||
0819|082|H|often, or take it for a longer time than prescribed. Properly||
0819|083|H|stop the medication when so directed.||
0819|084|H|   Pain medications work best if they are used when the first||
0819|085|H|signs of pain occur. If you wait until the pain has worsened, the||
0819|086|H|medication may not work as well.||
0819|087|H|   If you have ongoing pain (such as due to cancer), your doctor||
0819|088|H|may direct you to also take long-acting opioid medications. In||
0819|089|H|that case, this medication might be used for sudden||
0819|090|H|(breakthrough) pain only as needed. Other pain relievers (such as||
0819|091|H|acetaminophen, ibuprofen) may also be prescribed with this||
0819|092|H|medication. Ask your doctor or pharmacist about using morphine||
0819|093|H|safely with other drugs.||
0819|094|H|   Suddenly stopping this medication may cause withdrawal,||
0819|095|H|especially if you have used it for a long time or in high doses.||
0819|096|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0819|097|H|Tell your doctor or pharmacist right away if you have any||
0819|098|H|withdrawal symptoms such as restlessness, mental/mood changes||
0819|099|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0819|100|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0819|101|H|aches, or sudden changes in behavior.||
0819|102|H|   When this medication is used for a long time, it may not work||
0819|103|H|as well. Talk with your doctor if this medication stops working||
0819|104|H|well.||
0819|105|H|   Though it helps many people, this medication may sometimes||
0819|106|H|cause addiction. This risk may be higher if you have a||
0819|107|H|mental/mood disorder or a substance use disorder (such as overuse||
0819|108|H|of or addiction to drugs/alcohol). Take this medication exactly||
0819|109|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0819|110|H|pharmacist for more details.||
0819|111|H|   Tell your doctor if your pain does not get better or if it||
0819|112|H|gets worse, or if you have any new pain.||
0819|113|B|||
0819|114|S|SIDE EFFECTS:  See also Warning section.||
0819|115|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0819|116|S|drowsiness, or sweating may occur. Some of these side effects may||
0819|117|S|decrease after you have been using this medication for a while.||
0819|118|S|If any of these effects last or get worse, tell your doctor or||
0819|119|S|pharmacist promptly.||
0819|120|S|   To prevent constipation, eat dietary fiber, drink enough||
0819|121|S|water, and exercise. You may also need to take a laxative. Ask||
0819|122|S|your pharmacist which type of laxative is right for you.||
0819|123|S|   To reduce the risk of dizziness and lightheadedness, get up||
0819|124|S|slowly when rising from a sitting or lying position.||
0819|125|S|   Remember that this medication has been prescribed because your||
0819|126|S|doctor has judged that the benefit to you is greater than the||
0819|127|S|risk of side effects. Many people using this medication do not||
0819|128|S|have serious side effects.||
0819|129|S|   Tell your doctor right away if you have any serious side||
0819|130|S|effects, including: interrupted breathing during sleep (sleep||
0819|131|S|apnea), mental/mood changes (such as agitation, confusion,||
0819|132|S|hallucinations), severe stomach/abdominal pain, difficulty||
0819|133|S|urinating, signs of your adrenal glands not working well (such as||
0819|134|S|loss of appetite, unusual tiredness, weight loss), trouble||
0819|135|S|swallowing.||
0819|136|S|   Get medical help right away if you have any very serious side||
0819|137|S|effects, including: fainting, seizure, slow/shallow breathing,||
0819|138|S|severe drowsiness/difficulty waking up.||
0819|139|S|   A very serious allergic reaction to this drug is rare.||
0819|140|S|However, get medical help right away if you notice any symptoms||
0819|141|S|of a serious allergic reaction, including: rash, itching/swelling||
0819|142|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0819|143|S|breathing.||
0819|144|S|   This is not a complete list of possible side effects. If you||
0819|145|S|notice other effects not listed above, contact your doctor or||
0819|146|S|pharmacist.||
0819|147|S|   In the US -||
0819|148|S|   Call your doctor for medical advice about side effects. You||
0819|149|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0819|150|S|www.fda.gov/medwatch.||
0819|151|S|   In Canada - Call your doctor for medical advice about side||
0819|152|S|effects. You may report side effects to Health Canada at||
0819|153|S|1-866-234-2345.||
0819|154|B|||
0819|155|P|PRECAUTIONS:  Before taking morphine, tell your doctor or||
0819|156|P|pharmacist if you are allergic to it; or to other opioid pain||
0819|157|P|medications (such as codeine); or if you have any other||
0819|158|P|allergies. This product may contain inactive ingredients, which||
0819|159|P|can cause allergic reactions or other problems. Talk to your||
0819|160|P|pharmacist for more details.||
0819|161|P|   Before using this medication, tell your doctor or pharmacist||
0819|162|P|your medical history, especially of: brain disorders (such as||
0819|163|P|head injury, tumor, seizures), breathing problems (such as||
0819|164|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0819|165|P|kidney disease, liver disease, mental/mood disorders (such as||
0819|166|P|confusion, depression), personal or family history of a substance||
0819|167|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
0819|168|P|stomach/intestinal problems (such as blockage, constipation,||
0819|169|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
0819|170|P|(such as due to enlarged prostate), disease of the pancreas||
0819|171|P|(pancreatitis), gallbladder disease.||
0819|172|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0819|173|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0819|174|P|machinery, or do anything that needs alertness until you can do||
0819|175|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0819|176|P|are using marijuana (cannabis).||
0819|177|P|   Before having surgery, tell your doctor or dentist about all||
0819|178|P|the products you use (including prescription drugs,||
0819|179|P|nonprescription drugs, and herbal products).||
0819|180|P|   Liquid products may contain sugar, aspartame, and/or alcohol.||
0819|181|P|Caution is advised if you have diabetes, alcohol dependence,||
0819|182|P|liver disease, phenylketonuria (PKU), or any other condition that||
0819|183|P|requires you to limit/avoid these substances in your diet. Ask||
0819|184|P|your doctor or pharmacist about using this product safely.||
0819|185|P|   Older adults may be more sensitive to the side effects of this||
0819|186|P|drug, especially confusion, dizziness, drowsiness, and||
0819|187|P|slow/shallow breathing.||
0819|188|P|   During pregnancy, this medication should be used only when||
0819|189|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0819|190|P|benefits with your doctor. (See also Warning section.)||
0819|191|P|   This drug passes into breast milk and may have undesirable||
0819|192|P|effects on a nursing infant. Tell the doctor right away if your||
0819|193|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0819|194|P|breathing. Consult your doctor before breastfeeding.||
0819|195|B|||
0819|196|I|DRUG INTERACTIONS:  See also Warning section.||
0819|197|I|   Drug interactions may change how your medications work or||
0819|198|I|increase your risk for serious side effects. This document does||
0819|199|I|not contain all possible drug interactions. Keep a list of all||
0819|200|I|the products you use (including prescription/nonprescription||
0819|201|I|drugs and herbal products) and share it with your doctor and||
0819|202|I|pharmacist. Do not start, stop, or change the dosage of any||
0819|203|I|medicines without your doctor's approval.||
0819|204|I|   Some products that may interact with this drug include:||
0819|205|I|certain pain medications (mixed opioid agonist/antagonists such||
0819|206|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0819|207|I|samidorphan.||
0819|208|I|   The risk of serious side effects (such as slow/shallow||
0819|209|I|breathing, severe drowsiness/dizziness) may be increased if this||
0819|210|I|medication is taken with other products that may also cause||
0819|211|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0819|212|I|if you are taking other products such as other opioid pain or||
0819|213|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0819|214|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0819|215|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0819|216|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0819|217|I|cetirizine, diphenhydramine).||
0819|218|I|   Check the labels on all your medicines (such as allergy or||
0819|219|I|cough-and-cold products) because they may contain ingredients||
0819|220|I|that cause drowsiness. Ask your pharmacist about using those||
0819|221|I|products safely.||
0819|222|I|   This medication may interfere with certain lab tests (such as||
0819|223|I|amylase/lipase levels), possibly causing false test results. Make||
0819|224|I|sure lab personnel and all your doctors know you use this drug.||
0819|225|B|||
0819|226|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0819|227|O|as passing out or trouble breathing, give them naloxone or||
0819|228|O|nalmefene if available, then call 911. If the person is awake and||
0819|229|O|has no symptoms, call a poison control center right away. US||
0819|230|O|residents can call 1-800-222-1222. Canada residents can call||
0819|231|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0819|232|O|breathing, slow heartbeat, coma.||
0819|233|B|||
0819|234|N|NOTES:  Do not share this medication with others. Sharing it is||
0819|235|N|against the law.||
0819|236|N|   This medication has been prescribed for your current condition||
0819|237|N|only. Do not use it later for another condition unless told to do||
0819|238|N|so by your doctor. A different medication may be necessary in||
0819|239|N|that case.||
0819|240|B|||
0819|241|D|MISSED DOSE:  If you are taking this medication on a regular||
0819|242|D|schedule and miss a dose, take it as soon as you remember. If it||
0819|243|D|is near the time of the next dose, skip the missed dose. Take||
0819|244|D|your next dose at the regular time. Do not double the dose to||
0819|245|D|catch up.||
0819|246|B|||
0819|247|R|STORAGE:  Store at room temperature away from light and moisture.||
0819|248|R|Do not store in the bathroom. Keep all medications away from||
0819|249|R|children and pets. See also Warning section.||
0819|250|R|   Do not flush medications down the toilet or pour them into a||
0819|251|R|drain unless instructed to do so. Properly discard this product||
0819|252|R|when it is expired or no longer needed. For more details, read||
0819|253|R|the Medication Guide, or consult your pharmacist or local waste||
0819|254|R|disposal company.||
0819|255|B|||
0819|256|A|Information last revised August 2025.||
0819|257|A|Copyright(c) 2025 First Databank, Inc.||
0819|258|B|||
0821|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0821|002|Z|does NOT have all possible information about this product. This||
0821|003|Z|information does not assure that this product is safe, effective,||
0821|004|Z|or appropriate for you. This information is not individual||
0821|005|Z|medical advice and does not substitute for the advice of your||
0821|006|Z|health care professional. Always ask your health care||
0821|007|Z|professional for complete information about this product and your||
0821|008|Z|specific health needs.||
0821|009|B|||
0821|010|T|PSEUDOEPHEDRINE SUSTAINED-RELEASE - ORAL||
0821|011|F|(sue-doh-eff-ED-rin)||
0821|012|B|||
0821|013|C|COMMON BRAND NAME(S): Afrin, Dimetapp, Drixoral, Sudafed||
0821|014|B|||
0821|015|U|USES:  Pseudoephedrine is used for the temporary relief of stuffy||
0821|016|U|nose and sinus pain/pressure caused by infection (such as the||
0821|017|U|common cold, flu) or other breathing illnesses (such as hay||
0821|018|U|fever, allergies, bronchitis). Pseudoephedrine is a decongestant||
0821|019|U|(sympathomimetic). It works by narrowing the blood vessels to||
0821|020|U|decrease swelling and congestion.||
0821|021|U|   If you are self-treating with this medication, it is important||
0821|022|U|to read the manufacturer's package instructions carefully so you||
0821|023|U|know when to consult your doctor or pharmacist. (See also||
0821|024|U|Precautions section.)||
0821|025|U|   Cough-and-cold products have not been shown to be safe or||
0821|026|U|effective in children younger than 6 years. Long-acting||
0821|027|U|tablets/capsules are not recommended for use in children younger||
0821|028|U|than 12 years. Do not use this pseudoephedrine product in||
0821|029|U|children younger than 12 years unless specifically directed by||
0821|030|U|the doctor. Ask your doctor or pharmacist for more details about||
0821|031|U|using your product safely.||
0821|032|U|   These products do not cure or shorten the length of the common||
0821|033|U|cold and may cause serious side effects. To decrease the risk for||
0821|034|U|serious side effects, carefully follow all dosage directions. Do||
0821|035|U|not use this product to make a child sleepy. Do not give other||
0821|036|U|cough-and-cold medication that might contain the same or similar||
0821|037|U|ingredients (see also Drug Interactions section). Ask the doctor||
0821|038|U|or pharmacist about other ways to relieve cough and cold symptoms||
0821|039|U|(such as drinking enough fluids, using a humidifier or saline||
0821|040|U|nose drops/spray).||
0821|041|B|||
0821|042|V|OTHER USES:  This section contains uses of this drug that are not||
0821|043|V|listed in the approved professional labeling for the drug but||
0821|044|V|that may be prescribed by your health care professional. Use this||
0821|045|V|drug for a condition that is listed in this section only if it||
0821|046|V|has been so prescribed by your health care professional.||
0821|047|V|   Your doctor may direct you to use pseudoephedrine to decrease||
0821|048|V|pain and swelling in the ear or to help "open up" the ear canal||
0821|049|V|when there is a change in air pressure (such as during air||
0821|050|V|travel, underwater diving). Follow your doctor's directions||
0821|051|V|carefully.||
0821|052|B|||
0821|053|H|HOW TO USE:  If you are taking the over-the-counter product to||
0821|054|H|self-treat, read all directions on the product package before||
0821|055|H|taking this medication. If you have any questions, ask your||
0821|056|H|doctor or pharmacist. If your doctor has prescribed this||
0821|057|H|medication, take it as directed.||
0821|058|H|   Take this medication by mouth with or without food, usually||
0821|059|H|every 12 or 24 hours, depending on the product or as directed by||
0821|060|H|your doctor or the product package. Do not take more than 240||
0821|061|H|milligrams in a day. The dosage is based on your age, medical||
0821|062|H|condition, and response to treatment. Do not increase your dose||
0821|063|H|or take this drug more often than directed. Do not take more of||
0821|064|H|this medication than recommended for your age.||
0821|065|H|   If you are using the suspension (liquid), shake the bottle||
0821|066|H|well before each dose. Use a medication-measuring device or spoon||
0821|067|H|to carefully measure the dose. Do not use a household spoon||
0821|068|H|because you may not get the correct dose.||
0821|069|H|   Take the capsules or tablets with a full glass of water.||
0821|070|H|Swallow whole. Do not crush or chew the capsules or tablets.||
0821|071|H|Doing so can release all of the drug at once, increasing the risk||
0821|072|H|of side effects.||
0821|073|H|   There are many brands and forms of pseudoephedrine available.||
0821|074|H|Read the dosing instructions carefully for each product because||
0821|075|H|the amount of pseudoephedrine may be different between products.||
0821|076|H|Do not take more pseudoephedrine than recommended.||
0821|077|H|   Caffeine can increase the side effects of this medication.||
0821|078|H|Avoid drinking large amounts of beverages containing caffeine||
0821|079|H|(coffee, tea, colas), eating large amounts of chocolate, or||
0821|080|H|taking nonprescription products that contain caffeine.||
0821|081|H|   Tell your doctor if your symptoms do not get better after 7||
0821|082|H|days or if they get worse or return, or if you have a headache||
0821|083|H|that doesn't go away, fever, or rash. If you think you may have a||
0821|084|H|serious medical problem, get medical help right away.||
0821|085|B|||
0821|086|S|SIDE EFFECTS:  Nausea, vomiting, trouble sleeping, dizziness,||
0821|087|S|headache, or nervousness may occur. If any of these effects last||
0821|088|S|or get worse, tell your doctor or pharmacist promptly. Stop||
0821|089|S|taking this medication and tell your doctor promptly if you have||
0821|090|S|dizziness, nervousness, or trouble sleeping.||
0821|091|S|   With some products, an empty tablet shell may appear in your||
0821|092|S|stool. This effect is harmless because your body has already||
0821|093|S|absorbed the medication.||
0821|094|S|   If your doctor has directed you to use this medication,||
0821|095|S|remember that your doctor has judged that the benefit to you is||
0821|096|S|greater than the risk of side effects. Many people using this||
0821|097|S|medication do not have serious side effects.||
0821|098|S|   This medication may raise your blood pressure. Check your||
0821|099|S|blood pressure regularly and tell your doctor if the results are||
0821|100|S|high.||
0821|101|S|   Stop taking this medication and tell your doctor right away if||
0821|102|S|you have any serious side effects, including: stomach/abdominal||
0821|103|S|pain that doesn't go away, fast/irregular/pounding heartbeat,||
0821|104|S|mental/mood changes (such as anxiety, confusion, restlessness),||
0821|105|S|shaking (tremor), difficulty urinating.||
0821|106|S|   A very serious allergic reaction to this drug is rare.||
0821|107|S|However, get medical help right away if you notice any symptoms||
0821|108|S|of a serious allergic reaction, including: rash, itching/swelling||
0821|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0821|110|S|breathing.||
0821|111|S|   This is not a complete list of possible side effects. If you||
0821|112|S|notice other effects not listed above, contact your doctor or||
0821|113|S|pharmacist.||
0821|114|S|   In the US -||
0821|115|S|   Call your doctor for medical advice about side effects. You||
0821|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0821|117|S|www.fda.gov/medwatch.||
0821|118|S|   In Canada - Call your doctor for medical advice about side||
0821|119|S|effects. You may report side effects to Health Canada at||
0821|120|S|1-866-234-2345.||
0821|121|B|||
0821|122|P|PRECAUTIONS:  Before taking pseudoephedrine, tell your doctor or||
0821|123|P|pharmacist if you are allergic to it; or if you have any other||
0821|124|P|allergies. Also tell your doctor if you have had negative||
0821|125|P|reactions to other sympathomimetics (such as ephedrine,||
0821|126|P|phenylephrine). This product may contain inactive ingredients,||
0821|127|P|which can cause allergic reactions or other problems. Talk to||
0821|128|P|your pharmacist for more details.||
0821|129|P|   If you have any of the following health problems, consult your||
0821|130|P|doctor or pharmacist before using this product: diabetes, a||
0821|131|P|certain eye condition (glaucoma), heart problems (such as heart||
0821|132|P|attack, chest pain, heart failure), fast/irregular heart beat,||
0821|133|P|high blood pressure, kidney disease, overactive thyroid||
0821|134|P|(hyperthyroidism), difficulty urinating (such as due to enlarged||
0821|135|P|prostate).||
0821|136|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0821|137|P|can make you more dizzy. Do not drive, use machinery, or do||
0821|138|P|anything that needs alertness until you can do it safely. Limit||
0821|139|P|alcoholic beverages. Talk to your doctor if you are using||
0821|140|P|marijuana (cannabis).||
0821|141|P|   Liquid products may contain sugar, alcohol, or aspartame.||
0821|142|P|Caution is advised if you have diabetes, alcohol dependence,||
0821|143|P|liver disease, phenylketonuria (PKU), or any other condition that||
0821|144|P|requires you to limit/avoid these substances in your diet. Ask||
0821|145|P|your doctor or pharmacist about using this product safely.||
0821|146|P|   If you have a severe narrowing of the esophagus, stomach, or||
0821|147|P|intestine, you should not use the 240-milligram sustained-release||
0821|148|P|pseudoephedrine products due to the risk of blockage.||
0821|149|P|   Before having surgery, tell your doctor or dentist about all||
0821|150|P|the products you use (including prescription drugs,||
0821|151|P|nonprescription drugs, and herbal products).||
0821|152|P|   Older adults may be more sensitive to the side effects of this||
0821|153|P|drug, especially fast/irregular heartbeat, dizziness, problems||
0821|154|P|urinating, trouble sleeping, or confusion.||
0821|155|P|   Children may be more sensitive to the side effects of this||
0821|156|P|drug, especially restlessness.||
0821|157|P|   During pregnancy, this medication should be used only when||
0821|158|P|clearly needed. Discuss the risks and benefits with your doctor.||
0821|159|P|   Pseudoephedrine passes into breast milk. Consult your doctor||
0821|160|P|before breastfeeding.||
0821|161|B|||
0821|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0821|163|I|medications work or increase your risk for serious side effects.||
0821|164|I|This document does not contain all possible drug interactions.||
0821|165|I|Keep a list of all the products you use (including||
0821|166|I|prescription/nonprescription drugs and herbal products) and share||
0821|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
0821|168|I|the dosage of any medicines without your doctor's approval.||
0821|169|I|   Taking MAO inhibitors with this medication may cause a serious||
0821|170|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0821|171|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0821|172|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0821|173|I|selegiline, tranylcypromine) during treatment with this||
0821|174|I|medication. Most MAO inhibitors should also not be taken for two||
0821|175|I|weeks before treatment with this medication. Ask your doctor when||
0821|176|I|to start or stop taking this medication.||
0821|177|I|   Check the labels on all your medicines (such as allergy or||
0821|178|I|cough-and-cold products) because they may contain similar||
0821|179|I|ingredients (decongestants such as phenylephrine). Ask your||
0821|180|I|pharmacist about using those products safely.||
0821|181|B|||
0821|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0821|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0821|184|O|poison control center right away. US residents can call||
0821|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0821|186|O|Symptoms of overdose may include: slow/shallow breathing,||
0821|187|O|hallucinations, seizures.||
0821|188|B|||
0821|189|N|NOTES:  Keep all medical and lab appointments.||
0821|190|B|||
0821|191|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0821|192|D|remember. If it is near the time of the next dose, skip the||
0821|193|D|missed dose. Take your next dose at the regular time. Do not||
0821|194|D|double the dose to catch up.||
0821|195|B|||
0821|196|R|STORAGE:  Different brands of this medication have different||
0821|197|R|storage needs. Check the product package for instructions on how||
0821|198|R|to store your brand, or ask your pharmacist. Keep all medications||
0821|199|R|away from children and pets.||
0821|200|R|   Do not flush medications down the toilet or pour them into a||
0821|201|R|drain unless instructed to do so. Properly discard this product||
0821|202|R|when it is expired or no longer needed. Consult your pharmacist||
0821|203|R|or local waste disposal company.||
0821|204|B|||
0821|205|A|Information last revised November 2025.||
0821|206|A|Copyright(c) 2025 First Databank, Inc.||
0821|207|B|||
0822|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0822|002|Z|does NOT have all possible information about this product. This||
0822|003|Z|information does not assure that this product is safe, effective,||
0822|004|Z|or appropriate for you. This information is not individual||
0822|005|Z|medical advice and does not substitute for the advice of your||
0822|006|Z|health care professional. Always ask your health care||
0822|007|Z|professional for complete information about this product and your||
0822|008|Z|specific health needs.||
0822|009|B|||
0822|010|T|POSACONAZOLE SUSPENSION - ORAL||
0822|011|F|(POE-sa-KON-a-zole)||
0822|012|B|||
0822|013|C|COMMON BRAND NAME(S): Noxafil||
0822|014|B|||
0822|015|U|USES:  Posaconazole is used to prevent certain fungal infections||
0822|016|U|in patients who have severely weakened immune systems (such as||
0822|017|U|patients who have had chemotherapy). It is also used to treat||
0822|018|U|fungal infections in the mouth and throat. It belongs to a class||
0822|019|U|of drugs known as azole antifungals. It works by stopping the||
0822|020|U|growth of fungi.||
0822|021|B|||
0822|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0822|023|H|from your pharmacist before you start taking posaconazole and||
0822|024|H|each time you get a refill. If you have any questions, ask your||
0822|025|H|doctor or pharmacist.||
0822|026|H|   Take this medication by mouth with a full meal as directed by||
0822|027|H|your doctor. If you cannot take this medication with a full meal,||
0822|028|H|then take it with a liquid nutritional supplement or a carbonated||
0822|029|H|beverage (such as ginger ale). Shake the medication well before||
0822|030|H|using. Carefully measure the medication using the provided||
0822|031|H|dose-measuring spoon. Do not use a household spoon because you||
0822|032|H|may not get the correct dose.||
0822|033|H|   The dosage and length of treatment are based on your medical||
0822|034|H|condition and response to treatment.||
0822|035|H|   For the best effect, take this antifungal at evenly spaced||
0822|036|H|times. To help you remember, take this medication at the same||
0822|037|H|time(s) every day.||
0822|038|H|   Continue to take this medication until the full prescribed||
0822|039|H|amount is finished, even if symptoms disappear after a few days.||
0822|040|H|Stopping the medication too early may result in a return of the||
0822|041|H|infection.||
0822|042|H|   This form of posaconazole may deliver different amounts of||
0822|043|H|medication than the tablet and delayed-release suspension forms.||
0822|044|H|Do not switch between the different forms of this medication||
0822|045|H|without your doctor's permission and directions.||
0822|046|H|   Tell your doctor if you have severe diarrhea or vomiting.||
0822|047|H|Posaconazole may not work as well.||
0822|048|H|   Tell your doctor if your condition does not get better or if||
0822|049|H|it gets worse, or if you cannot take this medication with a full||
0822|050|H|meal, a carbonated beverage, or a liquid nutritional supplement.||
0822|051|B|||
0822|052|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, abdominal||
0822|053|S|pain, dizziness, trouble sleeping, or stomach upset may occur. If||
0822|054|S|any of these effects last or get worse, tell your doctor or||
0822|055|S|pharmacist promptly.||
0822|056|S|   Remember that this medication has been prescribed because your||
0822|057|S|doctor has judged that the benefit to you is greater than the||
0822|058|S|risk of side effects. Many people using this medication do not||
0822|059|S|have serious side effects.||
0822|060|S|   This medication may raise your blood pressure. Check your||
0822|061|S|blood pressure regularly and tell your doctor if the results are||
0822|062|S|high.||
0822|063|S|   Tell your doctor right away if you have any serious side||
0822|064|S|effects, including: swelling hands/ankles/feet, signs of||
0822|065|S|infection (such as sore throat that doesn't go away, fever,||
0822|066|S|chills), unusual tiredness, weakness, muscle cramps, mental/mood||
0822|067|S|changes, easy bruising/bleeding, vaginal bleeding, shortness of||
0822|068|S|breath, increased thirst/urination.||
0822|069|S|   Get medical help right away if you have any very serious side||
0822|070|S|effects, including: fast/irregular heartbeat, severe dizziness,||
0822|071|S|fainting.||
0822|072|S|   Posaconazole has rarely caused very serious (possibly fatal)||
0822|073|S|liver disease. Tell your doctor right away if you develop||
0822|074|S|symptoms of liver disease, such as: nausea/vomiting that doesn't||
0822|075|S|stop, loss of appetite, severe stomach/abdominal pain, yellowing||
0822|076|S|eyes/skin, dark urine.||
0822|077|S|   A very serious allergic reaction to this drug is rare.||
0822|078|S|However, get medical help right away if you notice any symptoms||
0822|079|S|of a serious allergic reaction, including: rash, itching/swelling||
0822|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0822|081|S|breathing.||
0822|082|S|   Posaconazole can commonly cause a mild rash that is usually||
0822|083|S|not serious. However, you may not be able to tell it apart from a||
0822|084|S|rare rash that could be a sign of a severe allergic reaction. Get||
0822|085|S|medical help right away if you develop any rash.||
0822|086|S|   This is not a complete list of possible side effects. If you||
0822|087|S|notice other effects not listed above, contact your doctor or||
0822|088|S|pharmacist.||
0822|089|S|   In the US -||
0822|090|S|   Call your doctor for medical advice about side effects. You||
0822|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0822|092|S|www.fda.gov/medwatch.||
0822|093|S|   In Canada - Call your doctor for medical advice about side||
0822|094|S|effects. You may report side effects to Health Canada at||
0822|095|S|1-866-234-2345.||
0822|096|B|||
0822|097|P|PRECAUTIONS:  Before taking posaconazole, tell your doctor or||
0822|098|P|pharmacist if you are allergic to it; or to other azole||
0822|099|P|antifungals (such as ketoconazole); or if you have any other||
0822|100|P|allergies. This product may contain inactive ingredients, which||
0822|101|P|can cause allergic reactions or other problems. Talk to your||
0822|102|P|pharmacist for more details.||
0822|103|P|   Before using this medication, tell your doctor or pharmacist||
0822|104|P|your medical history, especially of: liver disease, kidney||
0822|105|P|disease.||
0822|106|P|   Posaconazole may cause a condition that affects the heart||
0822|107|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0822|108|P|serious (rarely fatal) fast/irregular heartbeat and other||
0822|109|P|symptoms (such as severe dizziness, fainting) that need medical||
0822|110|P|attention right away.||
0822|111|P|   The risk of QT prolongation may be increased if you have||
0822|112|P|certain medical conditions or are taking other drugs that may||
0822|113|P|cause QT prolongation. Before using posaconazole, tell your||
0822|114|P|doctor or pharmacist of all the drugs you take and if you have||
0822|115|P|any of the following conditions: certain heart problems (heart||
0822|116|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0822|117|P|history of certain heart problems (QT prolongation in the EKG,||
0822|118|P|sudden cardiac death).||
0822|119|P|   Low levels of potassium or magnesium in the blood may also||
0822|120|P|increase your risk of QT prolongation. This risk may increase if||
0822|121|P|you use certain drugs (such as diuretics/"water pills") or if you||
0822|122|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0822|123|P|Talk to your doctor about using posaconazole safely.||
0822|124|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0822|125|P|can make you more dizzy. Do not drive, use machinery, or do||
0822|126|P|anything that needs alertness until you can do it safely. Avoid||
0822|127|P|alcoholic beverages. Talk to your doctor if you are using||
0822|128|P|marijuana (cannabis). Alcohol may also increase the risk of||
0822|129|P|serious liver problems.||
0822|130|P|   Before having surgery, tell your doctor or dentist about all||
0822|131|P|the products you use (including prescription drugs,||
0822|132|P|nonprescription drugs, and herbal products).||
0822|133|P|   Older adults may be more sensitive to the side effects of this||
0822|134|P|drug, especially QT prolongation (see above).||
0822|135|P|   During pregnancy, this medication should be used only when||
0822|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
0822|137|P|   It is unknown if this drug passes into breast milk. Consult||
0822|138|P|your doctor before breastfeeding.||
0822|139|B|||
0822|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0822|141|I|medications work or increase your risk for serious side effects.||
0822|142|I|This document does not contain all possible drug interactions.||
0822|143|I|Keep a list of all the products you use (including||
0822|144|I|prescription/nonprescription drugs and herbal products) and share||
0822|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
0822|146|I|the dosage of any medicines without your doctor's approval.||
0822|147|I|   Other medications can affect the removal of posaconazole from||
0822|148|I|your body, which may affect how posaconazole works. Examples||
0822|149|I|include cimetidine, efavirenz, proton pump inhibitors (such as||
0822|150|I|esomeprazole, pantoprazole), rifamycins (such as rifabutin),||
0822|151|I|certain drugs used to treat seizures (such as phenytoin), among||
0822|152|I|others.||
0822|153|I|   This drug can slow down the removal of other drugs from your||
0822|154|I|body, which may affect how they work. Examples of affected drugs||
0822|155|I|include certain alpha blockers (such as alfuzosin, silodosin,||
0822|156|I|tamsulosin), certain benzodiazepines (such as midazolam),||
0822|157|I|dronedarone, ergot alkaloids (such as ergotamine,||
0822|158|I|dihydroergotamine), pimozide, quinidine, rivaroxaban, sirolimus,||
0822|159|I|certain "statin" drugs (such as lovastatin, simvastatin),||
0822|160|I|venetoclax, among others.||
0822|161|I|   Many drugs besides posaconazole may affect the heart rhythm||
0822|162|I|(QT prolongation), including pacritinib, among others.||
0822|163|B|||
0822|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0822|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0822|166|O|poison control center right away. US residents can call||
0822|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0822|168|B|||
0822|169|N|NOTES:  Do not share this medication with others.||
0822|170|N|   This medication has been prescribed for your current condition||
0822|171|N|only. Do not use it later to treat or prevent another infection||
0822|172|N|unless your doctor tells you to.||
0822|173|N|   Lab and/or medical tests (such as liver function, blood||
0822|174|N|pressure, blood mineral levels such as calcium, magnesium,||
0822|175|N|potassium) should be done before you start using this medication||
0822|176|N|and while you are using it. Keep all medical and lab||
0822|177|N|appointments. Consult your doctor for more details.||
0822|178|B|||
0822|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0822|180|D|remember. If it is near the time of the next dose, skip the||
0822|181|D|missed dose. Take your next dose at the regular time. Do not||
0822|182|D|double the dose to catch up.||
0822|183|B|||
0822|184|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
0822|185|R|medications away from children and pets.||
0822|186|R|   Do not flush medications down the toilet or pour them into a||
0822|187|R|drain unless instructed to do so. Properly discard this product||
0822|188|R|when it is expired or no longer needed. Consult your pharmacist||
0822|189|R|or local waste disposal company.||
0822|190|B|||
0822|191|A|Information last revised April 2025.||
0822|192|A|Copyright(c) 2025 First Databank, Inc.||
0822|193|B|||
0823|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0823|002|Z|does NOT have all possible information about this product. This||
0823|003|Z|information does not assure that this product is safe, effective,||
0823|004|Z|or appropriate for you. This information is not individual||
0823|005|Z|medical advice and does not substitute for the advice of your||
0823|006|Z|health care professional. Always ask your health care||
0823|007|Z|professional for complete information about this product and your||
0823|008|Z|specific health needs.||
0823|009|B|||
0823|010|T|MORPHINE - INJECTION||
0823|011|F|(MORE-feen)||
0823|012|B|||
0823|013|C|COMMON BRAND NAME(S): Duramorph, Infumorph||
0823|014|B|||
0823|015|W|WARNING:  Morphine has a risk for abuse and addiction, which can||
0823|016|W|lead to overdose and death. Morphine may also cause severe,||
0823|017|W|possibly fatal, breathing problems. To lower your risk, your||
0823|018|W|doctor should have you use the smallest dose of morphine that||
0823|019|W|works, and use it for the shortest possible time. See also How to||
0823|020|W|Use section for more information about addiction.||
0823|021|W|   Ask your doctor or pharmacist if you should have medication||
0823|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0823|023|W|Teach your family or household members about the signs of an||
0823|024|W|opioid overdose and how to treat it.||
0823|025|W|   The risk for severe breathing problems is higher when you||
0823|026|W|start this medication and after a dose increase, or if you use||
0823|027|W|the wrong dose/strength. Using this medication with alcohol or||
0823|028|W|other drugs that can cause drowsiness or breathing problems may||
0823|029|W|cause very serious side effects, including death. Be sure you||
0823|030|W|know how to use morphine and what other drugs you should avoid||
0823|031|W|using with it. See also Drug Interactions section. Get medical||
0823|032|W|help right away if any of these very serious side effects occur:||
0823|033|W|slow/shallow breathing, unusual lightheadedness, severe||
0823|034|W|drowsiness/dizziness, difficulty waking up.||
0823|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0823|036|W|or abuse. If someone accidentally uses or swallows this drug, get||
0823|037|W|medical help right away.||
0823|038|W|   Before using this medication, women of childbearing age should||
0823|039|W|talk with their doctor(s) about the risks and benefits. Tell your||
0823|040|W|doctor if you are pregnant or if you plan to become pregnant.||
0823|041|W|During pregnancy, this medication should be used only when||
0823|042|W|clearly needed. It may slightly increase the risk of birth||
0823|043|W|defects if used during the first two months of pregnancy. Also,||
0823|044|W|using it for a long time or in high doses near the expected||
0823|045|W|delivery date may harm the unborn baby. To lessen the risk, use||
0823|046|W|the smallest effective dose for the shortest possible time.||
0823|047|W|Babies born to mothers who use this drug for a long time may||
0823|048|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0823|049|W|doctor right away if you notice any symptoms in your newborn baby||
0823|050|W|such as crying that doesn't stop, slow/shallow breathing,||
0823|051|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0823|052|W|difficulty gaining weight.||
0823|053|B|||
0823|054|U|USES:  This medication is used to treat severe pain. Morphine||
0823|055|U|belongs to a class of drugs known as opioid analgesics. It works||
0823|056|U|in the brain to change how your body feels and responds to pain.||
0823|057|B|||
0823|058|H|HOW TO USE:  Depending on your product, this medication is given||
0823|059|H|by injection into a vein, into a muscle, or under the skin. Use||
0823|060|H|this product exactly as directed by your doctor. If you have||
0823|061|H|nausea after using this medication, ask your doctor or pharmacist||
0823|062|H|about ways to decrease it (such as lying down for 1 to 2 hours||
0823|063|H|with as little head movement as possible).||
0823|064|H|   Preservative-free morphine may also be given by a doctor as an||
0823|065|H|injection into the area around the spinal cord||
0823|066|H|(epidural/intrathecal). In this case, the medication is first||
0823|067|H|given in the hospital where you can be monitored closely. If your||
0823|068|H|doctor directs you to keep using this medication at home, it is||
0823|069|H|usually given as a continuous injection using an infusion pump||
0823|070|H|placed under your skin.||
0823|071|H|   The dosage is based on your medical condition and response to||
0823|072|H|treatment. Children's dosage may also be based on weight. Do not||
0823|073|H|increase your dose, use the medication more often, or use it for||
0823|074|H|a longer time than prescribed. Properly stop the medication when||
0823|075|H|so directed.||
0823|076|H|   If you are using this medication at home, learn all||
0823|077|H|preparation and usage instructions from your health care||
0823|078|H|professional. Before using, check this product for particles or||
0823|079|H|discoloration. If either is present, do not use the liquid.||
0823|080|H|Before injecting each dose, clean the injection site with rubbing||
0823|081|H|alcohol. If this medication is given into a muscle or under the||
0823|082|H|skin, change the injection site each time to lessen injury under||
0823|083|H|the skin. Learn how to store and discard medical supplies safely.||
0823|084|H|   Pain medications work best if they are used when the first||
0823|085|H|signs of pain occur. If you wait until the pain has worsened, the||
0823|086|H|medication may not work as well.||
0823|087|H|   Suddenly stopping this medication may cause withdrawal,||
0823|088|H|especially if you have used it for a long time or in high doses.||
0823|089|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0823|090|H|Tell your doctor or pharmacist right away if you have any||
0823|091|H|withdrawal symptoms such as restlessness, mental/mood changes||
0823|092|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0823|093|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0823|094|H|aches, or sudden changes in behavior.||
0823|095|H|   When this medication is used for a long time, it may not work||
0823|096|H|as well. Your doctor may need to increase your dose or change||
0823|097|H|your medication. Talk with your doctor if this medication stops||
0823|098|H|working well.||
0823|099|H|   Though it helps many people, this medication may sometimes||
0823|100|H|cause addiction. This risk may be higher if you have a||
0823|101|H|mental/mood disorder or a substance use disorder (such as overuse||
0823|102|H|of or addiction to drugs/alcohol). Use this medication exactly as||
0823|103|H|prescribed to lower the risk of addiction. Ask your doctor or||
0823|104|H|pharmacist for more details.||
0823|105|H|   Tell your doctor if your pain does not get better or if it||
0823|106|H|gets worse, or if you have any new pain.||
0823|107|B|||
0823|108|S|SIDE EFFECTS:  See also Warning section.||
0823|109|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0823|110|S|drowsiness, increased sweating, or dry mouth may occur. Pain,||
0823|111|S|redness, or swelling at the injection site may occur if this||
0823|112|S|medication is given into a muscle or under the skin. If any of||
0823|113|S|these effects last or get worse, tell your doctor or pharmacist||
0823|114|S|promptly.||
0823|115|S|   To prevent constipation, eat dietary fiber, drink enough||
0823|116|S|water, and exercise. You may also need to take a laxative. Ask||
0823|117|S|your pharmacist which type of laxative is right for you.||
0823|118|S|   To reduce the risk of dizziness and lightheadedness, get up||
0823|119|S|slowly when rising from a sitting or lying position.||
0823|120|S|   Remember that this medication has been prescribed because your||
0823|121|S|doctor has judged that the benefit to you is greater than the||
0823|122|S|risk of side effects. Many people using this medication do not||
0823|123|S|have serious side effects.||
0823|124|S|   Tell your doctor right away if you have any serious side||
0823|125|S|effects, including: interrupted breathing during sleep (sleep||
0823|126|S|apnea), mental/mood changes (such as agitation, hallucinations,||
0823|127|S|confusion), difficulty urinating, vision changes, slow/fast||
0823|128|S|heartbeat, severe stomach/abdominal pain, signs of your adrenal||
0823|129|S|glands not working well (such as loss of appetite, unusual||
0823|130|S|tiredness, weight loss), trouble swallowing.||
0823|131|S|   Get medical help right away if you have any very serious side||
0823|132|S|effects, including: slow/shallow breathing, fainting, severe||
0823|133|S|drowsiness/difficulty waking up, seizures.||
0823|134|S|   A very serious allergic reaction to this drug is rare.||
0823|135|S|However, get medical help right away if you notice any symptoms||
0823|136|S|of a serious allergic reaction, including: rash, itching/swelling||
0823|137|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0823|138|S|breathing.||
0823|139|S|   This is not a complete list of possible side effects. If you||
0823|140|S|notice other effects not listed above, contact your doctor or||
0823|141|S|pharmacist.||
0823|142|S|   In the US -||
0823|143|S|   Call your doctor for medical advice about side effects. You||
0823|144|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0823|145|S|www.fda.gov/medwatch.||
0823|146|S|   In Canada - Call your doctor for medical advice about side||
0823|147|S|effects. You may report side effects to Health Canada at||
0823|148|S|1-866-234-2345.||
0823|149|B|||
0823|150|P|PRECAUTIONS:  Before using morphine injection, tell your doctor||
0823|151|P|or pharmacist if you are allergic to it; or to other opioid pain||
0823|152|P|medications (such as codeine); or if you have any other||
0823|153|P|allergies. This product may contain inactive ingredients (such as||
0823|154|P|sulfites found in some brands), which can cause allergic||
0823|155|P|reactions or other problems. Talk to your pharmacist for more||
0823|156|P|details.||
0823|157|P|   Before using this medication, tell your doctor or pharmacist||
0823|158|P|your medical history, especially of: brain disorders (such as||
0823|159|P|head injury, tumor, seizures), breathing problems (such as||
0823|160|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0823|161|P|gallbladder disease, kidney disease, liver disease, mental/mood||
0823|162|P|disorders (such as confusion, depression, thoughts of suicide),||
0823|163|P|personal or family history of a substance use disorder (such as||
0823|164|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
0823|165|P|problems (such as blockage, constipation, diarrhea due to||
0823|166|P|infection, paralytic ileus), disease of the pancreas||
0823|167|P|(pancreatitis), difficulty urinating (such as due to enlarged||
0823|168|P|prostate).||
0823|169|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0823|170|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0823|171|P|machinery, or do anything that needs alertness until you can do||
0823|172|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0823|173|P|are using marijuana (cannabis).||
0823|174|P|   Before having surgery, tell your doctor or dentist about all||
0823|175|P|the products you use (including prescription drugs,||
0823|176|P|nonprescription drugs, and herbal products).||
0823|177|P|   Older adults may be more sensitive to the side effects of this||
0823|178|P|drug, especially confusion, dizziness, drowsiness, and||
0823|179|P|slow/shallow breathing.||
0823|180|P|   During pregnancy, this medication should be used only when||
0823|181|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0823|182|P|benefits with your doctor. (See also Warning section.)||
0823|183|P|   This drug passes into breast milk and may have undesirable||
0823|184|P|effects on a nursing infant. Tell the doctor right away if your||
0823|185|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0823|186|P|breathing. Consult your doctor before breastfeeding.||
0823|187|B|||
0823|188|I|DRUG INTERACTIONS:  See also Warning section.||
0823|189|I|   Drug interactions may change how your medications work or||
0823|190|I|increase your risk for serious side effects. This document does||
0823|191|I|not contain all possible drug interactions. Keep a list of all||
0823|192|I|the products you use (including prescription/nonprescription||
0823|193|I|drugs and herbal products) and share it with your doctor and||
0823|194|I|pharmacist. Do not start, stop, or change the dosage of any||
0823|195|I|medicines without your doctor's approval.||
0823|196|I|   Some products that may interact with this drug are: certain||
0823|197|I|pain medications (mixed opioid agonist/antagonists such as||
0823|198|I|butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.||
0823|199|I|   The risk of serious side effects (such as slow/shallow||
0823|200|I|breathing, severe drowsiness/dizziness) may be increased if this||
0823|201|I|medication is used with other products that may also cause||
0823|202|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0823|203|I|if you are taking other products such as other opioid pain or||
0823|204|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0823|205|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0823|206|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0823|207|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0823|208|I|cetirizine, diphenhydramine).||
0823|209|I|   Check the labels on all your medicines (such as allergy or||
0823|210|I|cough-and-cold products) because they may contain ingredients||
0823|211|I|that cause drowsiness. Ask your pharmacist about using those||
0823|212|I|products safely.||
0823|213|I|   This medication may interfere with certain lab tests (such as||
0823|214|I|amylase/lipase levels), possibly causing false test results. Make||
0823|215|I|sure lab personnel and all your doctors know you use this drug.||
0823|216|B|||
0823|217|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0823|218|O|as passing out or trouble breathing, give them naloxone or||
0823|219|O|nalmefene if available, then call 911. If the person is awake and||
0823|220|O|has no symptoms, call a poison control center right away. US||
0823|221|O|residents can call 1-800-222-1222. Canada residents can call||
0823|222|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0823|223|O|breathing, severe drowsiness, coma.||
0823|224|B|||
0823|225|N|NOTES:  Do not share this medication with others. Sharing it is||
0823|226|N|against the law.||
0823|227|N|   This medication has been prescribed for your current condition||
0823|228|N|only. Do not use it later for another condition unless told to do||
0823|229|N|so by your doctor. A different medication may be necessary in||
0823|230|N|that case.||
0823|231|B|||
0823|232|D|MISSED DOSE:  If you use this medication regularly and miss a||
0823|233|D|dose, use it as soon as you remember. If it is near the time of||
0823|234|D|the next dose, skip the missed dose. Use your next dose at the||
0823|235|D|regular time. Do not double the dose to catch up.||
0823|236|B|||
0823|237|R|STORAGE:  Store at room temperature away from light. Different||
0823|238|R|brands/packaging of this medication may have different storage||
0823|239|R|requirements. Read the package labeling or ask your pharmacist||
0823|240|R|for the storage requirements for the product you are using. Keep||
0823|241|R|all medications away from children and pets.||
0823|242|R|   Do not flush medications down the toilet or pour them into a||
0823|243|R|drain unless instructed to do so. Properly discard this product||
0823|244|R|when it is expired or no longer needed. Consult your pharmacist||
0823|245|R|or local waste disposal company.||
0823|246|B|||
0823|247|A|Information last revised August 2025.||
0823|248|A|Copyright(c) 2025 First Databank, Inc.||
0823|249|B|||
0824|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0824|002|Z|does NOT have all possible information about this product. This||
0824|003|Z|information does not assure that this product is safe, effective,||
0824|004|Z|or appropriate for you. This information is not individual||
0824|005|Z|medical advice and does not substitute for the advice of your||
0824|006|Z|health care professional. Always ask your health care||
0824|007|Z|professional for complete information about this product and your||
0824|008|Z|specific health needs.||
0824|009|B|||
0824|010|T|NEOMYCIN - ORAL||
0824|011|F|(nee-oh-MY-sin)||
0824|012|B|||
0824|013|C|COMMON BRAND NAME(S): Mycifradin||
0824|014|B|||
0824|015|W|WARNING:  This medication can rarely cause serious kidney||
0824|016|W|problems and nerve damage, resulting in permanent hearing loss||
0824|017|W|(including deafness or decreased hearing) and balance problems.||
0824|018|W|These serious side effects may occur even in people without||
0824|019|W|kidney problems and taking usual doses. Hearing problems may||
0824|020|W|occur long after neomycin has been stopped. The risk is increased||
0824|021|W|if you are older, already have kidney disease, or if you have a||
0824|022|W|severe loss of body water (dehydration). Your risk is also||
0824|023|W|increased if you receive high doses, or with longer use of this||
0824|024|W|medication. Careful monitoring by your doctor (which may include||
0824|025|W|hearing, kidney, and urine tests) will reduce the risk of these||
0824|026|W|side effects. Avoid other medications that may increase your risk||
0824|027|W|for these serious side effects if taken together with neomycin||
0824|028|W|(See also Drug Interactions section). Tell your doctor right away||
0824|029|W|if you notice any signs of these serious side effects, including:||
0824|030|W|ringing/roaring sounds in the ears, hearing loss, dizziness, or||
0824|031|W|an unusual decrease in the amount of your urine.||
0824|032|W|   Severe muscle and breathing problems may also rarely occur.||
0824|033|B|||
0824|034|U|USES:  This medication is used to decrease the risk of infection||
0824|035|U|after certain intestinal surgeries. Neomycin belongs to a class||
0824|036|U|of drugs known as aminoglycoside antibiotics. It works by||
0824|037|U|stopping the growth of bacteria in the intestines.||
0824|038|U|   Neomycin may also be used along with a special diet to treat a||
0824|039|U|certain serious brain problem (hepatic encephalopathy). This||
0824|040|U|condition is caused by too much of a certain natural substance||
0824|041|U|(ammonia). Normally, the liver gets rid of ammonia, but liver||
0824|042|U|disease can cause too much ammonia to build up in the body. This||
0824|043|U|medication helps treat encephalopathy by killing certain||
0824|044|U|intestinal bacteria that make ammonia.||
0824|045|U|   This antibiotic treats only bacterial infections. It will not||
0824|046|U|work for viral infections (such as common cold, flu). Using any||
0824|047|U|antibiotic when it is not needed can cause it to not work for||
0824|048|U|future infections.||
0824|049|B|||
0824|050|H|HOW TO USE:  Take this medication by mouth exactly as prescribed||
0824|051|H|by your doctor.||
0824|052|H|   To decrease the risk of infection after intestinal surgery,||
0824|053|H|take this medication as directed by your doctor, usually for 3 or||
0824|054|H|4 doses the day before surgery. Carefully follow your doctor's||
0824|055|H|directions for any diet restrictions and using this medication or||
0824|056|H|other products before surgery.||
0824|057|H|   For treating hepatic encephalopathy, take this medication as||
0824|058|H|directed by your doctor, usually four times a day for 5 to 6||
0824|059|H|days.||
0824|060|H|   The dosage is based on your medical condition and response to||
0824|061|H|treatment. To decrease your risk of hearing loss and other side||
0824|062|H|effects, take this medication at the lowest effective dose for||
0824|063|H|the shortest possible time. Do not increase your dose, take it||
0824|064|H|more often, or take it for a longer time than prescribed. The||
0824|065|H|manufacturer recommends that this medication should not be taken||
0824|066|H|for longer than 2 weeks during each treatment period.||
0824|067|H|   If you are taking this medication for hepatic encephalopathy,||
0824|068|H|take it at evenly spaced times for the best effect. To help you||
0824|069|H|remember, take it at the same times each day. Tell your doctor if||
0824|070|H|your condition lasts or gets worse.||
0824|071|B|||
0824|072|S|SIDE EFFECTS:  See also Warning section.||
0824|073|S|   Nausea, vomiting, and diarrhea may occur. If any of these||
0824|074|S|effects last or get worse, tell your doctor or pharmacist||
0824|075|S|promptly.||
0824|076|S|   Remember that this medication has been prescribed because your||
0824|077|S|doctor has judged that the benefit to you is greater than the||
0824|078|S|risk of side effects. Many people using this medication do not||
0824|079|S|have serious side effects.||
0824|080|S|   Tell your doctor right away if you have any serious side||
0824|081|S|effects, including: difficulty walking, numbness/tingling, muscle||
0824|082|S|twitching or weakness, seizure.||
0824|083|S|   A very serious allergic reaction to this drug is rare.||
0824|084|S|However, get medical help right away if you notice any symptoms||
0824|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0824|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0824|087|S|breathing.||
0824|088|S|   This is not a complete list of possible side effects. If you||
0824|089|S|notice other effects not listed above, contact your doctor or||
0824|090|S|pharmacist.||
0824|091|S|   In the US -||
0824|092|S|   Call your doctor for medical advice about side effects. You||
0824|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0824|094|S|www.fda.gov/medwatch.||
0824|095|S|   In Canada - Call your doctor for medical advice about side||
0824|096|S|effects. You may report side effects to Health Canada at||
0824|097|S|1-866-234-2345.||
0824|098|B|||
0824|099|P|PRECAUTIONS:  Before taking neomycin, tell your doctor or||
0824|100|P|pharmacist if you are allergic to it; or to other aminoglycoside||
0824|101|P|antibiotics (such as tobramycin); or if you have any other||
0824|102|P|allergies. This product may contain inactive ingredients, which||
0824|103|P|can cause allergic reactions or other problems. Talk to your||
0824|104|P|pharmacist for more details.||
0824|105|P|   Before using this medication, tell your doctor or pharmacist||
0824|106|P|your medical history, especially of: hearing problems (including||
0824|107|P|deafness, decreased hearing), intestinal problems (including||
0824|108|P|blockage, swelling, ulcers), kidney problems, myasthenia gravis,||
0824|109|P|Parkinson's disease.||
0824|110|P|   High doses or longer use of neomycin may cause your body to||
0824|111|P|not properly absorb some foods, nutrients (such as iron, Vitamins||
0824|112|P|A and B-12), and drugs (such as digoxin, warfarin). Consult your||
0824|113|P|doctor for more details.||
0824|114|P|   Neomycin may cause live bacterial vaccines (such as typhoid||
0824|115|P|vaccine) to not work well. Tell your health care professional||
0824|116|P|that you are using neomycin before having any||
0824|117|P|immunizations/vaccinations.||
0824|118|P|   Before having surgery, tell your doctor or dentist about all||
0824|119|P|the products you use (including prescription drugs,||
0824|120|P|nonprescription drugs, and herbal products).||
0824|121|P|   Newborn and premature babies may be more sensitive to the side||
0824|122|P|effects of this drug, especially hearing problems.||
0824|123|P|   This medication is not recommended for use during pregnancy.||
0824|124|P|Although there have been reports of harm in babies born to women||
0824|125|P|using similar drugs, the risk for harm may not be the same with||
0824|126|P|this drug. Discuss the risks and benefits with your doctor.||
0824|127|P|   It is unknown if this drug passes into breast milk. However,||
0824|128|P|many doctors consider breastfeeding safe while using this||
0824|129|P|medication. Consult your doctor before breastfeeding.||
0824|130|B|||
0824|131|I|DRUG INTERACTIONS:  See also Precautions section.||
0824|132|I|   Drug interactions may change how your medications work or||
0824|133|I|increase your risk for serious side effects. This document does||
0824|134|I|not contain all possible drug interactions. Keep a list of all||
0824|135|I|the products you use (including prescription/nonprescription||
0824|136|I|drugs and herbal products) and share it with your health care||
0824|137|I|professional. Do not start, stop, or change the dosage of any||
0824|138|I|medicines without your doctor's approval.||
0824|139|I|   Other medications that may affect the kidneys or hearing may||
0824|140|I|increase the risk of kidney damage or hearing loss if taken with||
0824|141|I|neomycin. Some examples include: amikacin, tobramycin,||
0824|142|I|amphotericin B, cidofovir, cisplatin, polymyxin B, cephalosporins||
0824|143|I|such as cephaloridine, nonsteroidal anti-inflammatory drugs||
0824|144|I|(NSAIDs) such as ibuprofen, among others.||
0824|145|B|||
0824|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0824|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0824|148|O|poison control center right away. US residents can call||
0824|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0824|150|B|||
0824|151|N|NOTES:  Do not share this medication with others.||
0824|152|N|   Lab and/or medical tests (such as hearing tests, kidney||
0824|153|N|function) may be done while you are taking this medication. Keep||
0824|154|N|all medical and lab appointments. Consult your doctor for more||
0824|155|N|details.||
0824|156|B|||
0824|157|D|MISSED DOSE:  If you are taking this drug before a scheduled||
0824|158|D|surgery to prevent infection and you miss a dose, take it as soon||
0824|159|D|as you remember. If it is near the time of the next dose, keep||
0824|160|D|taking your dosing schedule as directed and ask your doctor or||
0824|161|D|pharmacist right away for a new dosing schedule. Do not double||
0824|162|D|the dose to catch up.||
0824|163|D|   If you are taking this drug to treat hepatic encephalopathy||
0824|164|D|and you miss a dose, take it as soon as you remember. If it is||
0824|165|D|near the time of the next dose, skip the missed dose. Take your||
0824|166|D|next dose at the regular time. Do not double the dose to catch||
0824|167|D|up.||
0824|168|B|||
0824|169|R|STORAGE:  Store at room temperature away from light and moisture.||
0824|170|R|Do not store in the bathroom. Keep all medications away from||
0824|171|R|children and pets.||
0824|172|R|   Do not flush medications down the toilet or pour them into a||
0824|173|R|drain unless instructed to do so. Properly discard this product||
0824|174|R|when it is expired or no longer needed. Consult your pharmacist||
0824|175|R|or local waste disposal company.||
0824|176|B|||
0824|177|A|Information last revised May 2024.||
0824|178|A|Copyright(c) 2025 First Databank, Inc.||
0824|179|B|||
0825|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0825|002|Z|does NOT have all possible information about this product. This||
0825|003|Z|information does not assure that this product is safe, effective,||
0825|004|Z|or appropriate for you. This information is not individual||
0825|005|Z|medical advice and does not substitute for the advice of your||
0825|006|Z|health care professional. Always ask your health care||
0825|007|Z|professional for complete information about this product and your||
0825|008|Z|specific health needs.||
0825|009|B|||
0825|010|T|SALICYLIC ACID 6% SHAMPOO - TOPICAL||
0825|011|F|(SAL-i-SIL-ik)||
0825|012|B|||
0825|013|C|COMMON BRAND NAME(S): Salex||
0825|014|B|||
0825|015|U|USES:  Salicylic acid is used on the skin/scalp to treat||
0825|016|U|psoriasis and other dry, scaly skin conditions. It belongs to the||
0825|017|U|same class of drugs as aspirin (salicylates). This medication||
0825|018|U|should not be used by children younger than 2 years.||
0825|019|U|   Salicylic acid causes the skin to shed dead cells from its top||
0825|020|U|layer by increasing the amount of moisture in the skin and||
0825|021|U|dissolving the substance that makes the cells clump together.||
0825|022|U|This effect makes it easier to shed the skin cells, softens the||
0825|023|U|top layer of skin, and decreases scaling and dryness.||
0825|024|B|||
0825|025|H|HOW TO USE:  Wet hair and scalp with water. Apply shampoo to||
0825|026|H|scalp. Work the shampoo into a lather and then rinse off. Use as||
0825|027|H|often as directed by your doctor. Once your condition has||
0825|028|H|improved, your doctor may direct you to use this product only||
0825|029|H|occasionally or to stop using it.||
0825|030|H|   This medication should be used on the skin/scalp only. Be||
0825|031|H|careful to avoid your eyes, nostrils, mouth, and genitals. If||
0825|032|H|contact occurs, flush the area with cool water for 15 minutes. Be||
0825|033|H|careful when applying this medication because it can irritate||
0825|034|H|normal skin around the treated area.||
0825|035|H|   Do not use large amounts, apply more often, or use for a||
0825|036|H|longer time than directed. Your condition will not clear faster,||
0825|037|H|but the chance for side effects may be increased.||
0825|038|H|   Tell your doctor if your condition lasts or gets worse.||
0825|039|B|||
0825|040|S|SIDE EFFECTS:  Burning, redness, and peeling skin near the||
0825|041|S|treated area may occur. If any of these effects last or get||
0825|042|S|worse, contact your doctor or pharmacist promptly.||
0825|043|S|   Remember that this medication has been prescribed because your||
0825|044|S|doctor has judged that the benefit to you is greater than the||
0825|045|S|risk of side effects. Many people using this medication do not||
0825|046|S|have serious side effects.||
0825|047|S|   A very serious allergic reaction to this drug is rare.||
0825|048|S|However, get medical help right away if you notice any symptoms||
0825|049|S|of a serious allergic reaction, including: rash, itching/swelling||
0825|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0825|051|S|breathing.||
0825|052|S|   This is not a complete list of possible side effects. If you||
0825|053|S|notice other effects not listed above, contact your doctor or||
0825|054|S|pharmacist.||
0825|055|S|   In the US -||
0825|056|S|   Call your doctor for medical advice about side effects. You||
0825|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0825|058|S|www.fda.gov/medwatch.||
0825|059|S|   In Canada - Call your doctor for medical advice about side||
0825|060|S|effects. You may report side effects to Health Canada at||
0825|061|S|1-866-234-2345.||
0825|062|B|||
0825|063|P|PRECAUTIONS:  Before using salicylic acid, tell your doctor or||
0825|064|P|pharmacist if you are allergic to it; or to aspirin; or if you||
0825|065|P|have any other allergies. This product may contain inactive||
0825|066|P|ingredients, which can cause allergic reactions or other||
0825|067|P|problems. Talk to your pharmacist for more details.||
0825|068|P|   Before using this medication, tell your doctor or pharmacist||
0825|069|P|your medical history, especially of: kidney problems, liver||
0825|070|P|problems.||
0825|071|P|   Before using this product, tell your doctor if your skin is||
0825|072|P|cut, scraped, or irritated.||
0825|073|P|   Though it is unlikely to occur, children may be at greater||
0825|074|P|risk for side effects from absorbing this medication into the||
0825|075|P|blood stream while using this drug. This medication is similar to||
0825|076|P|aspirin, and so it should not be used by children or teenagers||
0825|077|P|younger than 18 years with a virus infection (such as chicken||
0825|078|P|pox, flu) or if they have recently received a vaccine because of||
0825|079|P|the risk of developing a serious condition (Reye's syndrome).||
0825|080|P|   During pregnancy, this product should be used only when||
0825|081|P|clearly needed. Discuss the risks and benefits with your doctor.||
0825|082|P|   It is unknown if this medication passes into breast milk.||
0825|083|P|Consult your doctor before breastfeeding.||
0825|084|B|||
0825|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0825|086|I|medications work or increase your risk for serious side effects.||
0825|087|I|This document does not contain all possible drug interactions.||
0825|088|I|Keep a list of all the products you use (including||
0825|089|I|prescription/nonprescription drugs and herbal products) and share||
0825|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
0825|091|I|the dosage of any medicines without your doctor's approval.||
0825|092|B|||
0825|093|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0825|094|O|has overdosed and has serious symptoms such as passing out or||
0825|095|O|trouble breathing, call 911. Otherwise, call a poison control||
0825|096|O|center right away. US residents can call 1-800-222-1222. Canada||
0825|097|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0825|098|O|include: nausea, vomiting, dizziness, hearing problems,||
0825|099|O|tiredness, fast breathing.||
0825|100|B|||
0825|101|N|NOTES:  Do not share this medication with others.||
0825|102|N|   Avoid getting this medication on clothing, wood, plastic,||
0825|103|N|metal, or other surfaces because it can cause damage.||
0825|104|B|||
0825|105|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0825|106|D|If it is near the time of the next dose, skip the missed dose.||
0825|107|D|Use your next dose at the regular time. Do not double the dose to||
0825|108|D|catch up.||
0825|109|B|||
0825|110|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
0825|111|R|medications away from children and pets.||
0825|112|R|   Do not flush medications down the toilet or pour them into a||
0825|113|R|drain unless instructed to do so. Properly discard this product||
0825|114|R|when it is expired or no longer needed. Consult your pharmacist||
0825|115|R|or local waste disposal company.||
0825|116|B|||
0825|117|A|Information last revised May 2024.||
0825|118|A|Copyright(c) 2025 First Databank, Inc.||
0825|119|B|||
0826|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0826|002|Z|does NOT have all possible information about this product. This||
0826|003|Z|information does not assure that this product is safe, effective,||
0826|004|Z|or appropriate for you. This information is not individual||
0826|005|Z|medical advice and does not substitute for the advice of your||
0826|006|Z|health care professional. Always ask your health care||
0826|007|Z|professional for complete information about this product and your||
0826|008|Z|specific health needs.||
0826|009|B|||
0826|010|T|FENTANYL TABLET - BUCCAL||
0826|011|F|(FEN-ta-nil)||
0826|012|B|||
0826|013|C|COMMON BRAND NAME(S): Fentora||
0826|014|B|||
0826|015|W|WARNING:  See also Uses section.||
0826|016|W|   Fentanyl has a risk for abuse and addiction, which can lead to||
0826|017|W|overdose and death. Fentanyl may also cause severe, possibly||
0826|018|W|fatal, breathing problems. Do not use fentanyl buccal tablets||
0826|019|W|unless you have been regularly taking moderate to large amounts||
0826|020|W|of opioid pain medication. Otherwise, it may cause overdose (even||
0826|021|W|death). To lower your risk, your doctor should have you use the||
0826|022|W|smallest dose of fentanyl that works, and use it for the shortest||
0826|023|W|possible time. See also How to Use section for more information||
0826|024|W|about addiction.||
0826|025|W|   Ask your doctor or pharmacist if you should have medication||
0826|026|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0826|027|W|Teach your family or household members about the signs of an||
0826|028|W|opioid overdose and how to treat it.||
0826|029|W|   The risk for severe breathing problems is higher when you||
0826|030|W|start this medication and after a dose increase, or if you use||
0826|031|W|the wrong dose/strength. Using this medication with alcohol or||
0826|032|W|other drugs that can cause drowsiness or breathing problems may||
0826|033|W|cause very serious side effects, including death. Be sure you||
0826|034|W|know how to use fentanyl and what other drugs you should avoid||
0826|035|W|using with it. See also Drug Interactions section. Get medical||
0826|036|W|help right away if any of these very serious side effects occur:||
0826|037|W|slow/shallow breathing, unusual lightheadedness, severe||
0826|038|W|drowsiness/dizziness, difficulty waking up.||
0826|039|W|   Carefully follow the specific directions for using fentanyl||
0826|040|W|buccal tablets. Since they are not taken the same way, different||
0826|041|W|forms of fentanyl (including lozenges, buccal tablets, patches)||
0826|042|W|do not have the same effects at equal strengths and should not be||
0826|043|W|substituted for each other. Tell your doctor or pharmacist of all||
0826|044|W|medications that you use, especially of drugs that can affect how||
0826|045|W|fentanyl works. Do not start, stop, or change the dosage of any||
0826|046|W|medicines you are using without your doctor's approval.||
0826|047|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0826|048|W|or abuse. If someone accidentally swallows this drug, get medical||
0826|049|W|help right away.||
0826|050|W|   To receive fentanyl in the United States, you must understand,||
0826|051|W|agree to, and carefully follow the requirements of the REMS||
0826|052|W|Program for this medication. If you live in Canada or any other||
0826|053|W|country, consult your doctor and pharmacist for your country's||
0826|054|W|regulations.||
0826|055|W|   Before using this medication, women of childbearing age should||
0826|056|W|talk with their doctor(s) about the risks and benefits. Tell your||
0826|057|W|doctor if you are pregnant or if you plan to become pregnant.||
0826|058|W|During pregnancy, this medication should be used only when||
0826|059|W|clearly needed. It may slightly increase the risk of birth||
0826|060|W|defects if used during the first two months of pregnancy. Also,||
0826|061|W|using it for a long time or in high doses near the expected||
0826|062|W|delivery date may harm the unborn baby. To lessen the risk, use||
0826|063|W|the smallest effective dose for the shortest possible time.||
0826|064|W|Babies born to mothers who use this drug for a long time may||
0826|065|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0826|066|W|doctor right away if you notice any symptoms in your newborn baby||
0826|067|W|such as crying that doesn't stop, slow/shallow breathing,||
0826|068|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0826|069|W|difficulty gaining weight.||
0826|070|B|||
0826|071|U|USES:  This medication is used to help relieve sudden||
0826|072|U|(breakthrough) cancer pain in people who are regularly taking||
0826|073|U|moderate to large amounts of opioid pain medication. Fentanyl||
0826|074|U|belongs to a class of drugs known as opioid analgesics. It works||
0826|075|U|in the brain to change how your body feels and responds to pain.||
0826|076|U|   This medication should not be used to relieve mild or||
0826|077|U|short-term pain (such as due to headache/migraine, dental||
0826|078|U|procedures, surgery).||
0826|079|B|||
0826|080|H|HOW TO USE:  Read the Medication Guide provided by your||
0826|081|H|pharmacist before you start using fentanyl and each time you get||
0826|082|H|a refill. Learn all usage and disposal instructions. If you have||
0826|083|H|any questions, ask your doctor or pharmacist.||
0826|084|H|   Use this medication as directed by your doctor. Just before||
0826|085|H|using, open the blister pack unit as directed. Do not push the||
0826|086|H|tablet through the foil of the blister pack because this could||
0826|087|H|damage the tablet. Place the tablet in your mouth either above a||
0826|088|H|rear molar tooth between your upper cheek and gum or under the||
0826|089|H|tongue. Leave the medication in place until it is dissolved||
0826|090|H|(usually 14 to 25 minutes). Do not break, bite, chew, suck, or||
0826|091|H|swallow the tablet whole. You may feel a gentle bubbling in your||
0826|092|H|mouth while the tablet dissolves. Do not eat or drink anything||
0826|093|H|while the tablet dissolves. If there is still some tablet left||
0826|094|H|after 30 minutes, swallow it with a glass of water. If you are||
0826|095|H|placing the tablet between your cheek and gum, remember to change||
0826|096|H|sides of the mouth between doses.||
0826|097|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0826|098|H|using this medication unless your doctor or pharmacist says you||
0826|099|H|may do so safely. Grapefruit can increase the chance of side||
0826|100|H|effects with this medicine. Ask your doctor or pharmacist for||
0826|101|H|more details.||
0826|102|H|   If you start to have side effects (such as dizziness, feeling||
0826|103|H|sick to your stomach, severe drowsiness) before finishing a dose,||
0826|104|H|your doctor may need to adjust your dose. Rinse your mouth with||
0826|105|H|water and spit the rest of the tablet into a sink or toilet.||
0826|106|H|Rinse the sink or flush the toilet afterward to finish proper||
0826|107|H|disposal. Tell your doctor promptly if this happens.||
0826|108|H|   The dosage is based on your medical condition and response to||
0826|109|H|treatment. If you need a second dose, wait 30 minutes after||
0826|110|H|starting the first dose. Do not use more than 2 doses per episode||
0826|111|H|of breakthrough pain. Wait at least 4 hours before using fentanyl||
0826|112|H|buccal tablets again for another episode of breakthrough pain. Do||
0826|113|H|not increase your dose, take the medication more often, or take||
0826|114|H|it for a longer time than prescribed.||
0826|115|H|   Pain medications work best if they are used when the first||
0826|116|H|signs of pain occur. If you wait until the pain has worsened, the||
0826|117|H|medication may not work as well.||
0826|118|H|   You should continue to also take your long-acting opioid||
0826|119|H|medication as directed by your doctor. Other pain relievers (such||
0826|120|H|as acetaminophen, ibuprofen) may also be prescribed. Ask your||
0826|121|H|doctor or pharmacist about using fentanyl safely with other||
0826|122|H|drugs.||
0826|123|H|   Suddenly stopping this medication may cause withdrawal,||
0826|124|H|especially if you have used it for a long time or in high doses.||
0826|125|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0826|126|H|Tell your doctor or pharmacist right away if you have any||
0826|127|H|withdrawal symptoms such as restlessness, mental/mood changes||
0826|128|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0826|129|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0826|130|H|aches, or sudden changes in behavior.||
0826|131|H|   When this medication is used for a long time, it may not work||
0826|132|H|as well. Talk with your doctor if this medication stops working||
0826|133|H|well.||
0826|134|H|   Though it helps many people, this medication may sometimes||
0826|135|H|cause addiction. This risk may be higher if you have a||
0826|136|H|mental/mood disorder or a substance use disorder (such as overuse||
0826|137|H|of or addiction to drugs/alcohol). Use this medication exactly as||
0826|138|H|prescribed to lower the risk of addiction. Ask your doctor or||
0826|139|H|pharmacist for more details.||
0826|140|H|   Tell your doctor if your pain does not get better or if it||
0826|141|H|gets worse, or if you have any new pain. Also tell your doctor if||
0826|142|H|you have more than 4 episodes of breakthrough pain daily or if||
0826|143|H|you need to use 2 doses of medication for each episode of pain.||
0826|144|B|||
0826|145|S|SIDE EFFECTS:  See also Warning section.||
0826|146|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0826|147|S|drowsiness, or headache may occur. Pain, sores, or irritation in||
0826|148|S|the mouth (where the medication has been applied) may also occur.||
0826|149|S|Some of these side effects may decrease after you have been using||
0826|150|S|this medication for a while. If any of these effects last or get||
0826|151|S|worse, tell your doctor or pharmacist promptly.||
0826|152|S|   To prevent constipation, eat dietary fiber, drink enough||
0826|153|S|water, and exercise. You may also need to take a laxative. Ask||
0826|154|S|your pharmacist which type of laxative is right for you.||
0826|155|S|   To reduce the risk of dizziness and lightheadedness, get up||
0826|156|S|slowly when rising from a sitting or lying position.||
0826|157|S|   Remember that this medication has been prescribed because your||
0826|158|S|doctor has judged that the benefit to you is greater than the||
0826|159|S|risk of side effects. Many people using this medication do not||
0826|160|S|have serious side effects.||
0826|161|S|   Tell your doctor right away if you have any serious side||
0826|162|S|effects, including: interrupted breathing during sleep (sleep||
0826|163|S|apnea), mental/mood changes (such as agitation, confusion,||
0826|164|S|hallucinations), severe stomach/abdominal pain, difficulty||
0826|165|S|urinating, signs of your adrenal glands not working well (such as||
0826|166|S|loss of appetite, unusual tiredness, weight loss), trouble||
0826|167|S|swallowing.||
0826|168|S|   Get medical help right away if you have any very serious side||
0826|169|S|effects, including: fainting, seizure, slow/shallow breathing,||
0826|170|S|severe drowsiness/difficulty waking up.||
0826|171|S|   This medication may increase serotonin and rarely cause a very||
0826|172|S|serious condition called serotonin syndrome/toxicity. The risk||
0826|173|S|increases if you are also taking other drugs that increase||
0826|174|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0826|175|S|take (see Drug Interactions section). Get medical help right away||
0826|176|S|if you develop some of the following symptoms: fast heartbeat,||
0826|177|S|hallucinations, loss of coordination, severe dizziness, severe||
0826|178|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0826|179|S|unusual agitation/restlessness.||
0826|180|S|   A very serious allergic reaction to this drug is rare.||
0826|181|S|However, get medical help right away if you notice any symptoms||
0826|182|S|of a serious allergic reaction, including: rash, itching/swelling||
0826|183|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0826|184|S|breathing.||
0826|185|S|   This is not a complete list of possible side effects. If you||
0826|186|S|notice other effects not listed above, contact your doctor or||
0826|187|S|pharmacist.||
0826|188|S|   In the US -||
0826|189|S|   Call your doctor for medical advice about side effects. You||
0826|190|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0826|191|S|www.fda.gov/medwatch.||
0826|192|S|   In Canada - Call your doctor for medical advice about side||
0826|193|S|effects. You may report side effects to Health Canada at||
0826|194|S|1-866-234-2345.||
0826|195|B|||
0826|196|P|PRECAUTIONS:  Before taking fentanyl, tell your doctor or||
0826|197|P|pharmacist if you are allergic to it; or if you have any other||
0826|198|P|allergies. This product may contain inactive ingredients, which||
0826|199|P|can cause allergic reactions or other problems. Talk to your||
0826|200|P|pharmacist for more details.||
0826|201|P|   Before using this medication, tell your doctor or pharmacist||
0826|202|P|your medical history, especially of: brain disorders (such as||
0826|203|P|head injury, tumor, seizures), breathing problems (such as||
0826|204|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0826|205|P|kidney disease, liver disease, mental/mood disorders (such as||
0826|206|P|confusion, depression), personal or family history of a substance||
0826|207|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
0826|208|P|stomach/intestinal problems (such as blockage, constipation,||
0826|209|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
0826|210|P|(such as due to enlarged prostate), gallbladder disease, disease||
0826|211|P|of the pancreas (pancreatitis).||
0826|212|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0826|213|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0826|214|P|machinery, or do anything that needs alertness until you can do||
0826|215|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0826|216|P|are using marijuana (cannabis).||
0826|217|P|   Before having surgery, tell your doctor or dentist about all||
0826|218|P|the products you use (including prescription drugs,||
0826|219|P|nonprescription drugs, and herbal products).||
0826|220|P|   Older adults may be more sensitive to the side effects of this||
0826|221|P|drug, especially confusion, dizziness, drowsiness, and||
0826|222|P|slow/shallow breathing.||
0826|223|P|   During pregnancy, this medication should be used only when||
0826|224|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0826|225|P|benefits with your doctor. (See also Warning section.)||
0826|226|P|   This drug passes into breast milk and may have undesirable||
0826|227|P|effects on a nursing infant. Tell the doctor right away if your||
0826|228|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0826|229|P|breathing. Consult your doctor before breastfeeding.||
0826|230|B|||
0826|231|I|DRUG INTERACTIONS:  See also Warning section.||
0826|232|I|   Drug interactions may change how your medications work or||
0826|233|I|increase your risk for serious side effects. This document does||
0826|234|I|not contain all possible drug interactions. Keep a list of all||
0826|235|I|the products you use (including prescription/nonprescription||
0826|236|I|drugs and herbal products) and share it with your doctor and||
0826|237|I|pharmacist. Do not start, stop, or change the dosage of any||
0826|238|I|medicines without your doctor's approval.||
0826|239|I|   Some products that may interact with this drug include:||
0826|240|I|certain pain medications (mixed opioid agonist-antagonists such||
0826|241|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0826|242|I|samidorphan.||
0826|243|I|   Other medications can affect the removal of fentanyl from your||
0826|244|I|body, which may affect how fentanyl works. Examples include azole||
0826|245|I|antifungals (such as itraconazole, ketoconazole), calcium channel||
0826|246|I|blockers (such as diltiazem, verapamil), HIV protease inhibitors||
0826|247|I|(such as nelfinavir), macrolide antibiotics (such as||
0826|248|I|erythromycin), mifepristone, nefazodone, rifamycins (such as||
0826|249|I|rifabutin), ritonavir, certain drugs used to treat seizures (such||
0826|250|I|as carbamazepine, phenytoin), among others.||
0826|251|I|   Taking MAO inhibitors with this medication may cause a serious||
0826|252|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0826|253|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0826|254|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0826|255|I|selegiline, tranylcypromine) during treatment with this||
0826|256|I|medication. Most MAO inhibitors should also not be taken for two||
0826|257|I|weeks before treatment with this medication. Ask your doctor when||
0826|258|I|to start or stop taking this medication.||
0826|259|I|   The risk of serious side effects (such as slow/shallow||
0826|260|I|breathing, severe drowsiness/dizziness) may be increased if this||
0826|261|I|medication is used with other products that may also cause||
0826|262|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0826|263|I|if you are taking other products such as other opioid pain or||
0826|264|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0826|265|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0826|266|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0826|267|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0826|268|I|cetirizine, diphenhydramine).||
0826|269|I|   Check the labels on all your medicines (such as allergy or||
0826|270|I|cough-and-cold products) because they may contain ingredients||
0826|271|I|that cause drowsiness. Ask your pharmacist about using those||
0826|272|I|products safely.||
0826|273|I|   The risk of serotonin syndrome/toxicity increases if you are||
0826|274|I|also taking other drugs that increase serotonin. Some examples||
0826|275|I|are street drugs such as MDMA/ "ecstasy," St. John's wort,||
0826|276|I|certain antidepressants (such as SSRIs like||
0826|277|I|fluoxetine/paroxetine, SNRIs like duloxetine/venlafaxine), among||
0826|278|I|others. The risk of serotonin syndrome/toxicity may be more||
0826|279|I|likely when you start or increase the dose of these drugs.||
0826|280|I|   This medication may interfere with certain lab tests (such as||
0826|281|I|amylase/lipase levels), possibly causing false test results. Make||
0826|282|I|sure lab personnel and all your doctors know you use this drug.||
0826|283|B|||
0826|284|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0826|285|O|as passing out or trouble breathing, give them naloxone or||
0826|286|O|nalmefene if available, then call 911. If the person is awake and||
0826|287|O|has no symptoms, call a poison control center right away. US||
0826|288|O|residents can call 1-800-222-1222. Canada residents can call||
0826|289|O|1-844-764-7669. Symptoms of overdose may include: slow breathing,||
0826|290|O|slow heartbeat, coma.||
0826|291|B|||
0826|292|N|NOTES:  Do not share this medication with others. Sharing it is||
0826|293|N|against the law.||
0826|294|N|   This medication has been prescribed for your current condition||
0826|295|N|only. Do not use it later for another condition unless told to do||
0826|296|N|so by your doctor. A different medication may be necessary in||
0826|297|N|that case.||
0826|298|B|||
0826|299|D|MISSED DOSE:  Not applicable.||
0826|300|B|||
0826|301|R|STORAGE:  Store at room temperature away from light and moisture.||
0826|302|R|Do not freeze. Do not store in the bathroom. Keep all medications||
0826|303|R|away from children and pets. See also Warning section.||
0826|304|R|   Do not flush medications down the toilet or pour them into a||
0826|305|R|drain unless instructed to do so. Properly discard this product||
0826|306|R|when it is expired or no longer needed. For more details, read||
0826|307|R|the Medication Guide, or consult your pharmacist or local waste||
0826|308|R|disposal company.||
0826|309|B|||
0826|310|A|Information last revised August 2025.||
0826|311|A|Copyright(c) 2025 First Databank, Inc.||
0826|312|B|||
0827|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0827|002|Z|does NOT have all possible information about this product. This||
0827|003|Z|information does not assure that this product is safe, effective,||
0827|004|Z|or appropriate for you. This information is not individual||
0827|005|Z|medical advice and does not substitute for the advice of your||
0827|006|Z|health care professional. Always ask your health care||
0827|007|Z|professional for complete information about this product and your||
0827|008|Z|specific health needs.||
0827|009|B|||
0827|010|T|SALICYLIC ACID/FLEX COLLODION COMBINATIONS LIQUID - TOPICAL||
0827|011|F|(SAL-i-SIL-ik/flexible ko-LOE-dee-un)||
0827|012|B|||
0827|013|C|COMMON BRAND NAME(S): Freezone, Gordofilm||
0827|014|B|||
0827|015|U|USES:  Some brands of this product are used on the skin to treat||
0827|016|U|common skin and foot (plantar) warts, while other brands are used||
0827|017|U|to remove corns and calluses.||
0827|018|U|   This product contains 2 main ingredients. Salicylic acid is a||
0827|019|U|keratolytic. It belongs to the same class of drugs as aspirin||
0827|020|U|(salicylates). It works by breaking down the thick top layer of||
0827|021|U|skin and increasing the amount of moisture in the skin. It causes||
0827|022|U|the wart, corn, or callus to gradually peel off. Flexible||
0827|023|U|collodion works by forming a protective coating over the treated||
0827|024|U|area. It helps to keep the area clean and also keeps the||
0827|025|U|salicylic acid and moisture in contact with the skin.||
0827|026|U|   This product should not be used on the face or on moles,||
0827|027|U|birthmarks, warts with hair growing from them, or genital/anal||
0827|028|U|warts.||
0827|029|U|   If you are self-treating with this medication, it is important||
0827|030|U|to read the package instructions carefully before you start using||
0827|031|U|this product to be sure it is right for you. (See also||
0827|032|U|Precautions section.)||
0827|033|B|||
0827|034|H|HOW TO USE:  Use this product on the skin as directed by your||
0827|035|H|doctor. If you are self-treating, follow all directions on the||
0827|036|H|product package. If you have any questions, ask your doctor or||
0827|037|H|pharmacist.||
0827|038|H|   First wash the affected area. You may soak it in warm water||
0827|039|H|for about 5 minutes to soften it. Dry thoroughly. Your doctor may||
0827|040|H|direct you to use a rough towel, pumice stone, callus file, or||
0827|041|H|emery board to gently remove the top dead layers of thickened||
0827|042|H|skin after soaking and before applying the liquid. Do not use||
0827|043|H|sharp objects. Removing the dead skin helps the medication to||
0827|044|H|work better. Do not try to rub the wart, corn, or callus off.||
0827|045|H|   Using the applicator provided, apply a thin coat of the||
0827|046|H|medication (one drop at a time) to cover the entire wart, corn,||
0827|047|H|or callus. To minimize irritation, be careful not to get the||
0827|048|H|liquid on surrounding skin. Let dry. Repeat this procedure 1 to 2||
0827|049|H|times daily as needed until the wart, corn, or callus is removed.||
0827|050|H|For warts, you may use this product for up to 12 weeks. For corns||
0827|051|H|and calluses, you may use it for up to 2 weeks. Wash hands after||
0827|052|H|use.||
0827|053|H|   Do not use this product on skin that is irritated, red, or||
0827|054|H|infected. Avoid contact with the eyes and face. If this product||
0827|055|H|gets on these areas or on healthy surrounding skin, wash it off||
0827|056|H|right away. Flush the eyes with water for 15 minutes. If||
0827|057|H|irritation lasts, contact your doctor right away.||
0827|058|H|   Do not apply a large amount of this medication or apply it to||
0827|059|H|a large area. Do not use it more often or for longer than||
0827|060|H|directed. Your condition will not improve any faster, and your||
0827|061|H|risk of side effects will increase.||
0827|062|H|   Avoid inhaling the fumes from this product.||
0827|063|H|   If your condition lasts or gets worse, or if you think you may||
0827|064|H|have a serious medical problem, stop using this product and get||
0827|065|H|medical help right away.||
0827|066|B|||
0827|067|S|SIDE EFFECTS:  Mild skin burning, redness, and peeling of the||
0827|068|S|treated area may occur as expected. However, if any of these||
0827|069|S|effects last or get worse, tell your doctor or pharmacist||
0827|070|S|promptly.||
0827|071|S|   If your doctor has directed you to use this product, remember||
0827|072|S|that your doctor has judged that the benefit to you is greater||
0827|073|S|than the risk of side effects. Many people using this product do||
0827|074|S|not have serious side effects.||
0827|075|S|   Tell your doctor right away if you have any serious side||
0827|076|S|effects, including: unusual changes in the treated area (such as||
0827|077|S|discharge or bleeding, formation of a deep sore/ulcer).||
0827|078|S|   A very serious allergic reaction to this drug is rare.||
0827|079|S|However, get medical help right away if you notice any symptoms||
0827|080|S|of a serious allergic reaction, including: rash, itching/swelling||
0827|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0827|082|S|breathing.||
0827|083|S|   This is not a complete list of possible side effects. If you||
0827|084|S|notice other effects not listed above, contact your doctor or||
0827|085|S|pharmacist.||
0827|086|S|   In the US -||
0827|087|S|   Call your doctor for medical advice about side effects. You||
0827|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0827|089|S|www.fda.gov/medwatch.||
0827|090|S|   In Canada - Call your doctor for medical advice about side||
0827|091|S|effects. You may report side effects to Health Canada at||
0827|092|S|1-866-234-2345.||
0827|093|B|||
0827|094|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0827|095|P|pharmacist if you are allergic to salicylic acid, aspirin, or||
0827|096|P|nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen,||
0827|097|P|naproxen); or to flexible collodion; or if you have any other||
0827|098|P|allergies. This product may contain inactive ingredients, which||
0827|099|P|can cause allergic reactions or other problems. Talk to your||
0827|100|P|pharmacist for more details.||
0827|101|P|   Before using this product, tell your doctor or pharmacist your||
0827|102|P|medical history, especially of: skin irritation/infection/redness||
0827|103|P|in the area to be treated, diabetes, poor blood circulation (such||
0827|104|P|as peripheral vascular disease).||
0827|105|P|   Before having surgery, tell your doctor or dentist about all||
0827|106|P|the products you use (including prescription drugs,||
0827|107|P|nonprescription drugs, and herbal products).||
0827|108|P|   During pregnancy, this product should be used only when||
0827|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
0827|110|P|   It is unknown if this product passes into breast milk. Consult||
0827|111|P|your doctor before breastfeeding.||
0827|112|B|||
0827|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0827|114|I|medications work or increase your risk for serious side effects.||
0827|115|I|This document does not contain all possible drug interactions.||
0827|116|I|Keep a list of all the products you use (including||
0827|117|I|prescription/nonprescription drugs and herbal products) and share||
0827|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
0827|119|I|the dosage of any medicines without your doctor's approval.||
0827|120|B|||
0827|121|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0827|122|O|has overdosed and has serious symptoms such as passing out or||
0827|123|O|trouble breathing, call 911. Otherwise, call a poison control||
0827|124|O|center right away. US residents can call 1-800-222-1222. Canada||
0827|125|O|residents can call 1-844-764-7669.||
0827|126|B|||
0827|127|N|NOTES:  Keep all medical and lab appointments.||
0827|128|B|||
0827|129|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0827|130|D|If it is near the time of the next dose, skip the missed dose.||
0827|131|D|Use your next dose at the regular time. Do not double the dose to||
0827|132|D|catch up.||
0827|133|B|||
0827|134|R|STORAGE:  Store at room temperature. This product is flammable.||
0827|135|R|Keep it away from heat or open flame. Keep all medications away||
0827|136|R|from children and pets.||
0827|137|R|   Do not flush medications down the toilet or pour them into a||
0827|138|R|drain unless instructed to do so. Properly discard this product||
0827|139|R|when it is expired or no longer needed. Consult your pharmacist||
0827|140|R|or local waste disposal company.||
0827|141|B|||
0827|142|A|Information last revised July 2025.||
0827|143|A|Copyright(c) 2025 First Databank, Inc.||
0827|144|B|||
0829|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0829|002|Z|does NOT have all possible information about this product. This||
0829|003|Z|information does not assure that this product is safe, effective,||
0829|004|Z|or appropriate for you. This information is not individual||
0829|005|Z|medical advice and does not substitute for the advice of your||
0829|006|Z|health care professional. Always ask your health care||
0829|007|Z|professional for complete information about this product and your||
0829|008|Z|specific health needs.||
0829|009|B|||
0829|010|T|UREA (KERATOLYTIC) - TOPICAL||
0829|011|F|(ue-REE-a)||
0829|012|B|||
0829|013|C|COMMON BRAND NAME(S): Kerafoam, Keralac, Kerol, Umecta||
0829|014|B|||
0829|015|U|USES:  Urea is used to treat dry/rough skin conditions (such as||
0829|016|U|eczema, psoriasis, corns, callus) and some nail problems (such as||
0829|017|U|ingrown nails). It may also be used to help remove dead tissue in||
0829|018|U|some wounds to help wound healing. Urea is known as a||
0829|019|U|keratolytic. It increases moisture in the skin by||
0829|020|U|softening/dissolving the horny substance (keratin) holding the||
0829|021|U|top layer of skin cells together. This effect helps the dead skin||
0829|022|U|cells fall off and helps the skin keep more water in.||
0829|023|B|||
0829|024|H|HOW TO USE:  Use this product as directed. Follow all directions||
0829|025|H|on the product package and prescription label. If you have any||
0829|026|H|questions, ask your doctor or pharmacist.||
0829|027|H|   Some products need to be shaken well before use. Check the||
0829|028|H|label to see whether you should shake the bottle. Apply to the||
0829|029|H|affected areas of the skin/nails as directed by your doctor,||
0829|030|H|usually 1 to 3 times a day. Rub in well until absorbed. Wash your||
0829|031|H|hands after applying unless you are treating the hands. How often||
0829|032|H|you apply the medication will depend on the product and your skin||
0829|033|H|condition.||
0829|034|H|   Apply to the skin/nails only. Avoid sensitive areas such as||
0829|035|H|your eyes, lips, inside your mouth/nose, and the vaginal/groin||
0829|036|H|area, unless your doctor directs you otherwise. Ask your doctor||
0829|037|H|or check the label for directions about any areas or types of||
0829|038|H|skin where you should not apply the product (such as the face,||
0829|039|H|broken/chapped/cut/irritated/scraped skin, or recently shaved||
0829|040|H|skin). Ask your doctor if you should cover the treated area with||
0829|041|H|a bandage or gauze. Consult your doctor or pharmacist for more||
0829|042|H|details.||
0829|043|H|   Use this medication regularly to get the most benefit from it.||
0829|044|H|   Tell your doctor if your condition lasts or gets worse.||
0829|045|B|||
0829|046|S|SIDE EFFECTS:  Burning, itching, stinging, redness, or irritation||
0829|047|S|may occur. If any of these effects last or get worse, tell your||
0829|048|S|doctor or pharmacist promptly.||
0829|049|S|   Remember that this medication has been prescribed because your||
0829|050|S|doctor has judged that the benefit to you is greater than the||
0829|051|S|risk of side effects. Many people using this medication do not||
0829|052|S|have serious side effects.||
0829|053|S|   Tell your doctor right away if you have any serious side||
0829|054|S|effects, including: unusual changes in the skin (such as||
0829|055|S|blistering, peeling), signs of skin infection.||
0829|056|S|   A very serious allergic reaction to this drug is rare.||
0829|057|S|However, get medical help right away if you notice any symptoms||
0829|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0829|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0829|060|S|breathing.||
0829|061|S|   This is not a complete list of possible side effects. If you||
0829|062|S|notice other effects not listed above, contact your doctor or||
0829|063|S|pharmacist.||
0829|064|S|   In the US -||
0829|065|S|   Call your doctor for medical advice about side effects. You||
0829|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0829|067|S|www.fda.gov/medwatch.||
0829|068|S|   In Canada - Call your doctor for medical advice about side||
0829|069|S|effects. You may report side effects to Health Canada at||
0829|070|S|1-866-234-2345.||
0829|071|B|||
0829|072|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0829|073|P|pharmacist if you are allergic to it; or if you have any other||
0829|074|P|allergies. This product may contain inactive ingredients, which||
0829|075|P|can cause allergic reactions or other problems. Talk to your||
0829|076|P|pharmacist for more details.||
0829|077|P|   Before using this medication, tell your doctor or pharmacist||
0829|078|P|your medical history, especially of: skin cuts/infections/sores.||
0829|079|P|   Some products may make you more sensitive to the sun. Check||
0829|080|P|the label for any warnings or ask your doctor or pharmacist||
0829|081|P|whether you need to take any special precautions when in the sun.||
0829|082|P|Your doctor/pharmacist may suggest that you limit your time in||
0829|083|P|the sun, avoid tanning booths and sunlamps, and use sunscreen and||
0829|084|P|wear protective clothing when outdoors. Tell your doctor right||
0829|085|P|away if you get sunburned or have skin blisters/redness.||
0829|086|P|   Some products may stain/discolor clothing. Ask your doctor or||
0829|087|P|pharmacist for more details.||
0829|088|P|   During pregnancy, this medication should be used only when||
0829|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
0829|090|P|   It is unknown if drug passes into breast milk. Consult your||
0829|091|P|doctor before breastfeeding.||
0829|092|B|||
0829|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0829|094|I|medications work or increase your risk for serious side effects.||
0829|095|I|This document does not contain all possible drug interactions.||
0829|096|I|Keep a list of all the products you use (including||
0829|097|I|prescription/nonprescription drugs and herbal products) and share||
0829|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
0829|099|I|the dosage of any medicines without your doctor's approval.||
0829|100|B|||
0829|101|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0829|102|O|has overdosed and has serious symptoms such as passing out or||
0829|103|O|trouble breathing, call 911. Otherwise, call a poison control||
0829|104|O|center right away. US residents can call 1-800-222-1222. Canada||
0829|105|O|residents can call 1-844-764-7669.||
0829|106|B|||
0829|107|N|NOTES:  Do not share this medication with others.||
0829|108|N|   This medication has been prescribed for your current condition||
0829|109|N|only. Do not use it later for another condition unless told to do||
0829|110|N|so by your doctor. A different medication may be necessary in||
0829|111|N|that case.||
0829|112|B|||
0829|113|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0829|114|D|If it is near the time of the next dose, skip the missed dose.||
0829|115|D|Use your next dose at the regular time. Do not use more of this||
0829|116|D|product or use it more often to catch up.||
0829|117|B|||
0829|118|R|STORAGE:  Store at room temperature. Do not freeze. Store foam||
0829|119|R|product away from heat and open flame. Because the contents of||
0829|120|R|the foam canister are under pressure, do not puncture or burn the||
0829|121|R|container. Keep all medications away from children and pets.||
0829|122|R|   Do not flush medications down the toilet or pour them into a||
0829|123|R|drain unless instructed to do so. Properly discard this product||
0829|124|R|when it is expired or no longer needed. Consult your pharmacist||
0829|125|R|or local waste disposal company.||
0829|126|B|||
0829|127|A|Information last revised October 2024.||
0829|128|A|Copyright(c) 2025 First Databank, Inc.||
0829|129|B|||
0830|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0830|002|Z|does NOT have all possible information about this product. This||
0830|003|Z|information does not assure that this product is safe, effective,||
0830|004|Z|or appropriate for you. This information is not individual||
0830|005|Z|medical advice and does not substitute for the advice of your||
0830|006|Z|health care professional. Always ask your health care||
0830|007|Z|professional for complete information about this product and your||
0830|008|Z|specific health needs.||
0830|009|B|||
0830|010|T|CLINDAMYCIN SINGLE DOSE CREAM - VAGINAL||
0830|011|F|(KLIN-da-MYE-sin)||
0830|012|B|||
0830|013|C|COMMON BRAND NAME(S): Clindesse||
0830|014|B|||
0830|015|U|USES:  This medication is used to treat a certain type of vaginal||
0830|016|U|infection (bacterial vaginosis) in women who are not pregnant.||
0830|017|U|Clindamycin is an antibiotic that works by stopping the growth of||
0830|018|U|bacteria.||
0830|019|B|||
0830|020|H|HOW TO USE:  Read the Patient Information Leaflet that comes with||
0830|021|H|this product for instructions on the proper use of this||
0830|022|H|medication. Consult your doctor or pharmacist if you have any||
0830|023|H|questions.||
0830|024|H|   This product is for vaginal use only. Wash your hands before||
0830|025|H|and after use. Avoid contact of this cream with your eyes. If it||
0830|026|H|gets into your eyes, wash them right away with plenty of water.||
0830|027|H|Call your doctor if eye irritation lasts.||
0830|028|H|   Insert the applicator filled with medication high into the||
0830|029|H|vagina and press the plunger to release the medication. This||
0830|030|H|product is given as a single dose. This product may be used at||
0830|031|H|any time of the day because it is designed to leak very little||
0830|032|H|medication out of the vagina.||
0830|033|H|   Tell your doctor if your condition does not get better after||
0830|034|H|several days.||
0830|035|B|||
0830|036|S|SIDE EFFECTS:  Although uncommon, mild stomach upset may occur.||
0830|037|S|If this effect lasts or gets worse, tell your doctor or||
0830|038|S|pharmacist promptly.||
0830|039|S|   Rarely, vaginal discomfort/burning/itching/discharge may occur||
0830|040|S|or worsen. These symptoms may be due to a new vaginal infection||
0830|041|S|(such as a yeast/fungal infection). Contact your doctor if you||
0830|042|S|notice a change in vaginal discharge or other new vaginal||
0830|043|S|symptoms.||
0830|044|S|   Remember that this medication has been prescribed because your||
0830|045|S|doctor has judged that the benefit to you is greater than the||
0830|046|S|risk of side effects. Many people using this medication do not||
0830|047|S|have serious side effects.||
0830|048|S|   A very small amount of this medication may be absorbed into||
0830|049|S|your blood and may rarely cause a severe intestinal condition due||
0830|050|S|to a bacteria called C. difficile. This condition may occur||
0830|051|S|during treatment or weeks to months after treatment has stopped.||
0830|052|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0830|053|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0830|054|S|stool.||
0830|055|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0830|056|S|products because they may make symptoms worse.||
0830|057|S|   A very serious allergic reaction to this drug is rare.||
0830|058|S|However, get medical help right away if you notice any symptoms||
0830|059|S|of a serious allergic reaction, including: rash, itching/swelling||
0830|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0830|061|S|breathing.||
0830|062|S|   This is not a complete list of possible side effects. If you||
0830|063|S|notice other effects not listed above, contact your doctor or||
0830|064|S|pharmacist.||
0830|065|S|   In the US -||
0830|066|S|   Call your doctor for medical advice about side effects. You||
0830|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0830|068|S|www.fda.gov/medwatch.||
0830|069|S|   In Canada - Call your doctor for medical advice about side||
0830|070|S|effects. You may report side effects to Health Canada at||
0830|071|S|1-866-234-2345.||
0830|072|B|||
0830|073|P|PRECAUTIONS:  Before using clindamycin, tell your doctor or||
0830|074|P|pharmacist if you are allergic to it; or to lincomycin; or if you||
0830|075|P|have any other allergies. This product may contain inactive||
0830|076|P|ingredients, which can cause allergic reactions or other||
0830|077|P|problems. Talk to your pharmacist for more details.||
0830|078|P|   Before using this medication, tell your doctor or pharmacist||
0830|079|P|your medical history, especially of: intestinal disease (such as||
0830|080|P|C. difficile-associated diarrhea, enteritis, ulcerative colitis).||
0830|081|P|   Do not have vaginal intercourse or use tampons or douches||
0830|082|P|during treatment with this medication because these can cause the||
0830|083|P|cream to not work as well.||
0830|084|P|   The mineral oil in this product can weaken rubber products||
0830|085|P|such as latex condoms and diaphragms and lead to their failure.||
0830|086|P|Do not use these products during treatment with this medication||
0830|087|P|and for 5 days after treatment is over. Consult your doctor about||
0830|088|P|other forms of barrier protection/birth control (such as||
0830|089|P|polyurethane condoms) during this time.||
0830|090|P|   During pregnancy, this medication should be used only when||
0830|091|P|clearly needed. Antibiotics taken by mouth have been used to||
0830|092|P|treat vaginal infections during pregnancy, especially high-risk||
0830|093|P|pregnancies (such as if there is a risk of early childbirth).||
0830|094|P|Consult your doctor for more details and to discuss the risks and||
0830|095|P|benefits.||
0830|096|P|   It is unknown if the medication in this product passes into||
0830|097|P|breast milk. Consult your doctor before breastfeeding.||
0830|098|B|||
0830|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0830|100|I|medications work or increase your risk for serious side effects.||
0830|101|I|This document does not contain all possible drug interactions.||
0830|102|I|Keep a list of all the products you use (including||
0830|103|I|prescription/nonprescription drugs and herbal products) and share||
0830|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
0830|105|I|the dosage of any medicines without your doctor's approval.||
0830|106|B|||
0830|107|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0830|108|O|has overdosed and has serious symptoms such as passing out or||
0830|109|O|trouble breathing, call 911. Otherwise, call a poison control||
0830|110|O|center right away. US residents can call 1-800-222-1222. Canada||
0830|111|O|residents can call 1-844-764-7669.||
0830|112|B|||
0830|113|N|NOTES:  Do not share this medication with others.||
0830|114|N|   This medication has been prescribed for your current condition||
0830|115|N|only. Do not use it later for another infection unless your||
0830|116|N|doctor tells you to.||
0830|117|B|||
0830|118|D|MISSED DOSE:  Not applicable.||
0830|119|B|||
0830|120|R|STORAGE:  Store at room temperature away from heat. Keep all||
0830|121|R|medications away from children and pets.||
0830|122|R|   Do not flush medications down the toilet or pour them into a||
0830|123|R|drain unless instructed to do so. Properly discard this product||
0830|124|R|when it is expired or no longer needed. Consult your pharmacist||
0830|125|R|or local waste disposal company.||
0830|126|B|||
0830|127|A|Information last revised January 2025.||
0830|128|A|Copyright(c) 2025 First Databank, Inc.||
0830|129|B|||
0831|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0831|002|Z|does NOT have all possible information about this product. This||
0831|003|Z|information does not assure that this product is safe, effective,||
0831|004|Z|or appropriate for you. This information is not individual||
0831|005|Z|medical advice and does not substitute for the advice of your||
0831|006|Z|health care professional. Always ask your health care||
0831|007|Z|professional for complete information about this product and your||
0831|008|Z|specific health needs.||
0831|009|B|||
0831|010|T|DESONIDE FOAM - TOPICAL||
0831|011|F|(DES-oh-nide)||
0831|012|B|||
0831|013|C|COMMON BRAND NAME(S): Verdeso||
0831|014|B|||
0831|015|U|USES:  This medication is used to treat a certain skin condition||
0831|016|U|(atopic dermatitis). Desonide reduces the swelling, itching, and||
0831|017|U|redness that can occur in this type of condition. Desonide is a||
0831|018|U|mild corticosteroid.||
0831|019|B|||
0831|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0831|021|H|from your pharmacist before you start using desonide and each||
0831|022|H|time you get a refill. If you have any questions, ask your doctor||
0831|023|H|or pharmacist.||
0831|024|H|   Use this medication only on the skin.||
0831|025|H|   Shake the can well before using. Wash your hands. Clean and||
0831|026|H|dry the affected area. Hold the can upside down to spray the foam||
0831|027|H|onto the affected skin as directed by your doctor, usually 2||
0831|028|H|times daily. If you hold the bottle upright while spraying, you||
0831|029|H|may not get enough medication in the foam. If treating the face,||
0831|030|H|do not spray directly onto the face. Instead, spray the foam onto||
0831|031|H|the hand and then apply to the face. After applying the foam,||
0831|032|H|gently rub in until the medication disappears. Do not bandage,||
0831|033|H|wrap, or cover the area unless you are instructed to do so by||
0831|034|H|your doctor. If used in the diaper area on an infant, do not use||
0831|035|H|tight-fitting diapers or plastic pants.||
0831|036|H|   After applying the medication, wash and dry your hands, unless||
0831|037|H|you are using this medication to treat the hands. Avoid getting||
0831|038|H|this medication in the eyes, nose, or mouth. If you get the||
0831|039|H|medication in these areas, rinse with plenty of water.||
0831|040|H|   Use this medication only for the condition for which it was||
0831|041|H|prescribed. Do not use it for longer than prescribed.||
0831|042|H|   Tell your doctor if your condition lasts or gets worse after 4||
0831|043|H|weeks.||
0831|044|B|||
0831|045|S|SIDE EFFECTS:  Stinging, burning, irritation, dryness, or redness||
0831|046|S|at the application site may occur. Acne, new/unwanted hair||
0831|047|S|growth, small red bumps on the skin (folliculitis), skin||
0831|048|S|thinning/discoloration, or stretch marks may also occur. If any||
0831|049|S|of these effects last or get worse, tell your doctor or||
0831|050|S|pharmacist promptly.||
0831|051|S|   Remember that this medication has been prescribed because your||
0831|052|S|doctor has judged that the benefit to you is greater than the||
0831|053|S|risk of side effects. Many people using this medication do not||
0831|054|S|have serious side effects.||
0831|055|S|   Skin infections can become worse while you are using this||
0831|056|S|medication. Tell your doctor promptly if redness, swelling, or||
0831|057|S|irritation does not improve.||
0831|058|S|   A very serious allergic reaction to this drug is rare.||
0831|059|S|However, get medical help right away if you notice any symptoms||
0831|060|S|of a serious allergic reaction, including: rash, itching/swelling||
0831|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0831|062|S|breathing.||
0831|063|S|   This is not a complete list of possible side effects. If you||
0831|064|S|notice other effects not listed above, contact your doctor or||
0831|065|S|pharmacist.||
0831|066|S|   In the US -||
0831|067|S|   Call your doctor for medical advice about side effects. You||
0831|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0831|069|S|www.fda.gov/medwatch.||
0831|070|S|   In Canada - Call your doctor for medical advice about side||
0831|071|S|effects. You may report side effects to Health Canada at||
0831|072|S|1-866-234-2345.||
0831|073|B|||
0831|074|P|PRECAUTIONS:  Before using desonide, tell your doctor or||
0831|075|P|pharmacist if you are allergic to it; or to other corticosteroids||
0831|076|P|(such as hydrocortisone, prednisone); or if you have any other||
0831|077|P|allergies. This product may contain inactive ingredients, which||
0831|078|P|can cause allergic reactions or other problems. Talk to your||
0831|079|P|pharmacist for more details.||
0831|080|P|   Before using this medication, tell your doctor or pharmacist||
0831|081|P|your medical history.||
0831|082|P|   Do not use if there is an infection or sore in the area to be||
0831|083|P|treated.||
0831|084|P|   Before having surgery, tell your doctor or dentist about all||
0831|085|P|the products you use (including prescription drugs,||
0831|086|P|nonprescription drugs, and herbal products).||
0831|087|P|   Children may be more sensitive to the effects of too much||
0831|088|P|corticosteroid medication. Consult your doctor for more details.||
0831|089|P|   During pregnancy, this medication should be used only when||
0831|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
0831|091|P|   It is unknown if this medication, when applied to the skin,||
0831|092|P|passes into breast milk. However, similar drugs, when taken by||
0831|093|P|mouth, pass into breast milk. Consult your doctor before||
0831|094|P|breastfeeding.||
0831|095|B|||
0831|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0831|097|I|medications work or increase your risk for serious side effects.||
0831|098|I|This document does not contain all possible drug interactions.||
0831|099|I|Keep a list of all the products you use (including||
0831|100|I|prescription/nonprescription drugs and herbal products) and share||
0831|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0831|102|I|the dosage of any medicines without your doctor's approval.||
0831|103|B|||
0831|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0831|105|O|has overdosed and has serious symptoms such as passing out or||
0831|106|O|trouble breathing, call 911. Otherwise, call a poison control||
0831|107|O|center right away. US residents can call 1-800-222-1222. Canada||
0831|108|O|residents can call 1-844-764-7669.||
0831|109|B|||
0831|110|N|NOTES:  Do not share this medication with others.||
0831|111|N|   This medication has been prescribed for your current condition||
0831|112|N|only. Do not use it later for other skin problems unless told to||
0831|113|N|do so by your doctor. A different medication may be necessary in||
0831|114|N|those cases.||
0831|115|N|   Tell all your doctors that you use or have used this||
0831|116|N|medication.||
0831|117|B|||
0831|118|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0831|119|D|If it is near the time of the next dose, skip the missed dose.||
0831|120|D|Use your next dose at the regular time. Do not double the dose to||
0831|121|D|catch up.||
0831|122|B|||
0831|123|R|STORAGE:  Store at room temperature. Do not freeze. Do not||
0831|124|R|puncture the can or expose to high heat or open flame. Keep all||
0831|125|R|medications away from children and pets.||
0831|126|R|   Do not flush medications down the toilet or pour them into a||
0831|127|R|drain unless instructed to do so. Properly discard this product||
0831|128|R|when it is expired or no longer needed. Consult your pharmacist||
0831|129|R|or local waste disposal company.||
0831|130|B|||
0831|131|A|Information last revised October 2024.||
0831|132|A|Copyright(c) 2025 First Databank, Inc.||
0831|133|B|||
0832|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0832|002|Z|does NOT have all possible information about this product. This||
0832|003|Z|information does not assure that this product is safe, effective,||
0832|004|Z|or appropriate for you. This information is not individual||
0832|005|Z|medical advice and does not substitute for the advice of your||
0832|006|Z|health care professional. Always ask your health care||
0832|007|Z|professional for complete information about this product and your||
0832|008|Z|specific health needs.||
0832|009|B|||
0832|010|T|DEXAMETHASONE OINTMENT - OPHTHALMIC||
0832|011|F|(dex-a-METH-a-sone)||
0832|012|B|||
0832|013|C|COMMON BRAND NAME(S): Decadron||
0832|014|B|||
0832|015|U|USES:  This medication is used to treat certain eye conditions||
0832|016|U|due to inflammation or injury. Dexamethasone works by relieving||
0832|017|U|symptoms such as swelling, redness, and itching. It belongs to a||
0832|018|U|class of drugs known as corticosteroids.||
0832|019|B|||
0832|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0832|021|H|directed by your doctor, usually 3 to 4 times a day.||
0832|022|H|   Do not wear contact lenses while you are using this medicine.||
0832|023|H|Sterilize contact lenses according to the manufacturer's||
0832|024|H|directions, and check with your doctor before you begin using||
0832|025|H|them again.||
0832|026|H|   To apply the eye ointment, wash your hands first. To avoid||
0832|027|H|contamination, do not touch the tube tip or let it touch your eye||
0832|028|H|or any other surface. Gently pull down the lower eyelid to make a||
0832|029|H|pouch. Place a 1/2 inch (1.5 centimeters) strip of ointment into||
0832|030|H|the pouch. Gently close the eye and roll the eyeball in all||
0832|031|H|directions to spread the medication. Try not to blink and do not||
0832|032|H|rub the eye.||
0832|033|H|   Repeat these steps for your other eye if so directed. Wipe the||
0832|034|H|tip of the ointment tube with a clean tissue to remove extra||
0832|035|H|medication before recapping it.||
0832|036|H|   If you are using another kind of eye medication (for example,||
0832|037|H|other drops or ointments), apply the eye drops first and wait at||
0832|038|H|least 5 to 10 minutes before applying this eye ointment. Use eye||
0832|039|H|drops before eye ointments to allow the drops to enter the eye.||
0832|040|H|   Wait several minutes for your vision to clear before driving||
0832|041|H|or operating machinery.||
0832|042|H|   Use this medication regularly in order to get the most benefit||
0832|043|H|from it. To help you remember, use it at the same time(s) each||
0832|044|H|day.||
0832|045|H|   The dosage and length of treatment are based on your medical||
0832|046|H|condition and response to treatment. Do not use this medication||
0832|047|H|more often or for longer than prescribed because doing so may||
0832|048|H|increase your risk of side effects.||
0832|049|H|   Continue to use this medication for the full time prescribed.||
0832|050|H|Do not stop using this medication without consulting your doctor.||
0832|051|H|Some conditions may become worse when the drug is suddenly||
0832|052|H|stopped. Your dose may need to be gradually decreased.||
0832|053|H|   Do not use this product if it becomes contaminated (for||
0832|054|H|example, ointment turns a dark color or develops particles in||
0832|055|H|it). Use of contaminated eye medication can cause infection,||
0832|056|H|serious damage to the eye, and loss of vision. Contact your||
0832|057|H|doctor or pharmacist for more information.||
0832|058|H|   Tell your doctor if your condition does not get better in a||
0832|059|H|few days or if it gets worse.||
0832|060|B|||
0832|061|S|SIDE EFFECTS:  Temporary blurred vision may occur when you apply||
0832|062|S|this medication. Rarely, stinging/burning of the eyes for 1 to 2||
0832|063|S|minutes may also occur. If any of these effects last or get||
0832|064|S|worse, tell your doctor or pharmacist promptly.||
0832|065|S|   Remember that this medication has been prescribed because your||
0832|066|S|doctor has judged that the benefit to you is greater than the||
0832|067|S|risk of side effects. Many people using this medication do not||
0832|068|S|have serious side effects.||
0832|069|S|   Use of this medication for prolonged periods or in high doses||
0832|070|S|may cause serious eye problems (such as high pressure inside the||
0832|071|S|eyes and cataracts). Tell your doctor right away if any of these||
0832|072|S|serious side effects occur: vision problems, eye pain.||
0832|073|S|   This medication may mask the signs of an eye infection. It may||
0832|074|S|also put you at greater risk of developing an eye infection,||
0832|075|S|especially with prolonged use. Report any new or worsening||
0832|076|S|symptoms such as eye discharge/swelling/redness or no improvement||
0832|077|S|of your current eye condition. Your doctor will need to adjust||
0832|078|S|your treatment.||
0832|079|S|   Tell your doctor right away if you have any serious side||
0832|080|S|effects, including: headache, dizziness.||
0832|081|S|   A very serious allergic reaction to this drug is rare.||
0832|082|S|However, get medical help right away if you notice any symptoms||
0832|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0832|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0832|085|S|breathing.||
0832|086|S|   This is not a complete list of possible side effects. If you||
0832|087|S|notice other effects not listed above, contact your doctor or||
0832|088|S|pharmacist.||
0832|089|S|   In the US -||
0832|090|S|   Call your doctor for medical advice about side effects. You||
0832|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0832|092|S|www.fda.gov/medwatch.||
0832|093|S|   In Canada - Call your doctor for medical advice about side||
0832|094|S|effects. You may report side effects to Health Canada at||
0832|095|S|1-866-234-2345.||
0832|096|B|||
0832|097|P|PRECAUTIONS:  Before using dexamethasone, tell your doctor or||
0832|098|P|pharmacist if you are allergic to it; or if you have any other||
0832|099|P|allergies. This product may contain inactive ingredients, which||
0832|100|P|can cause allergic reactions or other problems. Talk to your||
0832|101|P|pharmacist for more details.||
0832|102|P|   Before using this medication, tell your doctor or pharmacist||
0832|103|P|your medical history, especially of: eye infections, recent eye||
0832|104|P|surgery, cataracts, glaucoma (open-angle type), severe||
0832|105|P|nearsightedness (myopia), diabetes.||
0832|106|P|   After you apply this drug, your vision may become temporarily||
0832|107|P|blurred. Do not drive, use machinery, or do anything that needs||
0832|108|P|clear vision until you can do it safely.||
0832|109|P|   Before having surgery, tell your doctor or dentist about all||
0832|110|P|the products you use (including prescription drugs,||
0832|111|P|nonprescription drugs, and herbal products).||
0832|112|P|   If you develop a new eye infection or injury, or require eye||
0832|113|P|surgery, ask your doctor if you should continue to use your||
0832|114|P|current tube of dexamethasone eye ointment or start a new tube.||
0832|115|P|   During pregnancy, this medication should be used only when||
0832|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
0832|117|P|   It is unknown if this medication passes into breast milk.||
0832|118|P|Consult your doctor before breastfeeding.||
0832|119|B|||
0832|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0832|121|I|medications work or increase your risk for serious side effects.||
0832|122|I|This document does not contain all possible drug interactions.||
0832|123|I|Keep a list of all the products you use (including||
0832|124|I|prescription/nonprescription drugs and herbal products) and share||
0832|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
0832|126|I|the dosage of any medicines without your doctor's approval.||
0832|127|B|||
0832|128|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0832|129|O|has overdosed and has serious symptoms such as passing out or||
0832|130|O|trouble breathing, call 911. Otherwise, call a poison control||
0832|131|O|center right away. US residents can call 1-800-222-1222. Canada||
0832|132|O|residents can call 1-844-764-7669.||
0832|133|B|||
0832|134|N|NOTES:  Do not share this medication with others.||
0832|135|N|   This medication has been prescribed for your current condition||
0832|136|N|only. Do not use it later for another eye condition unless told||
0832|137|N|to do so by your doctor. A different medication may be necessary||
0832|138|N|in that case.||
0832|139|N|   Lab and/or medical tests (such as eye exams, measurement of||
0832|140|N|the pressure inside the eyes) may be done while you are using||
0832|141|N|this medication. Keep all medical and lab appointments. Consult||
0832|142|N|your doctor for more details.||
0832|143|B|||
0832|144|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0832|145|D|If it is near the time of the next dose, skip the missed dose.||
0832|146|D|Use your next dose at the regular time. Do not double the dose to||
0832|147|D|catch up.||
0832|148|B|||
0832|149|R|STORAGE:  Store at room temperature. Keep all medications away||
0832|150|R|from children and pets.||
0832|151|R|   Do not flush medications down the toilet or pour them into a||
0832|152|R|drain unless instructed to do so. Properly discard this product||
0832|153|R|when it is expired or no longer needed. Consult your pharmacist||
0832|154|R|or local waste disposal company.||
0832|155|B|||
0832|156|A|Information last revised November 2024.||
0832|157|A|Copyright(c) 2025 First Databank, Inc.||
0832|158|B|||
0833|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0833|002|Z|does NOT have all possible information about this product. This||
0833|003|Z|information does not assure that this product is safe, effective,||
0833|004|Z|or appropriate for you. This information is not individual||
0833|005|Z|medical advice and does not substitute for the advice of your||
0833|006|Z|health care professional. Always ask your health care||
0833|007|Z|professional for complete information about this product and your||
0833|008|Z|specific health needs.||
0833|009|B|||
0833|010|T|DEXAMETHASONE SOLUTION/SUSPENSION - OPHTHALMIC/OTIC||
0833|011|F|(dex-a-METH-a-sone)||
0833|012|B|||
0833|013|C|COMMON BRAND NAME(S): Maxidex||
0833|014|B|||
0833|015|U|USES:  This medication is used to treat certain eye conditions||
0833|016|U|due to inflammation or injury. Dexamethasone works by relieving||
0833|017|U|symptoms such as swelling, redness, and itching. It belongs to a||
0833|018|U|class of drugs known as corticosteroids.||
0833|019|U|   This medication may also be used to treat swelling, redness,||
0833|020|U|and itching of the outer ear due to inflammatory conditions.||
0833|021|B|||
0833|022|H|HOW TO USE:  EYE: Unless otherwise directed by your doctor, do||
0833|023|H|not wear contact lenses while you are using this medicine.||
0833|024|H|Sterilize contact lenses according to the manufacturer's||
0833|025|H|directions, and check with your doctor before you begin using||
0833|026|H|them again.||
0833|027|H|   If your doctor does approve the wearing of contact lenses||
0833|028|H|during treatment with this medication, remove the lenses before||
0833|029|H|using the eye drops. The preservative in this product may be||
0833|030|H|absorbed by contact lenses. Wait at least 15 minutes after each||
0833|031|H|dose of the eye drop before wearing the lenses again.||
0833|032|H|   To apply eye drops, wash your hands first. If you are using a||
0833|033|H|suspension form of this medication, shake the bottle well before||
0833|034|H|using. To avoid contamination, do not touch the dropper tip or||
0833|035|H|let it touch your eye or any other surface.||
0833|036|H|   Tilt your head back, look upward, and pull down the lower||
0833|037|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0833|038|H|and place 1 drop into the pouch. Look downward and gently close||
0833|039|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0833|040|H|your eye (near the nose) and apply gentle pressure. This will||
0833|041|H|prevent the medication from draining out. Try not to blink and do||
0833|042|H|not rub your eye. Repeat these steps for your other eye if so||
0833|043|H|directed and if your dose is for more than 1 drop.||
0833|044|H|   Apply as often as directed by your doctor. Do not rinse the||
0833|045|H|dropper. Replace the dropper cap after each use.||
0833|046|H|   If you are using another kind of eye medication (for example,||
0833|047|H|other drops or ointments), wait at least 5 to 10 minutes before||
0833|048|H|applying other medications. Use eye drops before eye ointments to||
0833|049|H|allow the drops to enter the eye.||
0833|050|H|   Wait several minutes for your vision to clear before driving||
0833|051|H|or operating machinery.||
0833|052|H|   EAR: Clean and dry the ear canal before using this medication.||
0833|053|H|To make sure the right amount of medication is given, and to||
0833|054|H|avoid touching the ear with the dropper, have another person||
0833|055|H|insert the drops if possible. To lower the risk of dizziness,||
0833|056|H|hold the container in your hand for a few minutes in order to||
0833|057|H|warm it.||
0833|058|H|   To apply ear drops, wash your hands first. To avoid||
0833|059|H|contamination, do not touch the dropper tip or let it touch your||
0833|060|H|ear or any other surface. If you are using a suspension form of||
0833|061|H|this medication, shake the bottle well before using. Lie on your||
0833|062|H|side or tilt the affected ear upward. Hold the dropper directly||
0833|063|H|over the ear and place the prescribed number of drops into the||
0833|064|H|ear canal. To help the drops roll into the ear of an adult, hold||
0833|065|H|the earlobe up and back. For children, hold the earlobe down and||
0833|066|H|back. Keep the head tilted for 5 minutes, or insert a soft cotton||
0833|067|H|plug if so directed. Alternatively, your doctor may instruct you||
0833|068|H|to place a cotton/gauze plug in the ear canal, moisten it with||
0833|069|H|the medication, and leave it in the ear for 12 to 24 hours or as||
0833|070|H|directed. The plug should be replaced at least once a day.||
0833|071|H|   Repeat these steps for the other ear if so directed. Apply as||
0833|072|H|often as directed by your doctor. Do not rinse the dropper.||
0833|073|H|Replace the dropper cap after each use.||
0833|074|H|   Use this medication regularly in order to get the most benefit||
0833|075|H|from it. To help you remember, use it at the same time(s) each||
0833|076|H|day.||
0833|077|H|   The dosage and length of treatment are based on your medical||
0833|078|H|condition and response to treatment. Do not use this medication||
0833|079|H|more often or for longer than prescribed because doing so may||
0833|080|H|increase your risk of side effects.||
0833|081|H|   Continue to use this medication for the full time prescribed.||
0833|082|H|Do not stop using this medication without consulting your doctor.||
0833|083|H|Some conditions may become worse when the drug is suddenly||
0833|084|H|stopped. Your dose may need to be gradually decreased.||
0833|085|H|   Do not use this product if it becomes contaminated (for||
0833|086|H|example, drops turn a dark color). Use of contaminated eye||
0833|087|H|medication can cause infection, serious damage to the eye, and||
0833|088|H|loss of vision. Use of contaminated ear medication can cause||
0833|089|H|infection, serious damage to the ear, and hearing loss. Contact||
0833|090|H|your doctor or pharmacist for more information.||
0833|091|H|   Tell your doctor if your condition does not get better in a||
0833|092|H|few days or if it gets worse.||
0833|093|B|||
0833|094|S|SIDE EFFECTS:  Rarely, stinging/burning of the eyes for 1 to 2||
0833|095|S|minutes may occur when you apply this medication. If used in the||
0833|096|S|ear, stinging/burning may also rarely occur. If any of these||
0833|097|S|effects last or get worse, tell your doctor or pharmacist||
0833|098|S|promptly.||
0833|099|S|   Remember that this medication has been prescribed because your||
0833|100|S|doctor has judged that the benefit to you is greater than the||
0833|101|S|risk of side effects. Many people using this medication do not||
0833|102|S|have serious side effects.||
0833|103|S|   Use of this medication for prolonged periods or in high doses||
0833|104|S|may cause serious eye problems (such as high pressure inside the||
0833|105|S|eyes and cataracts). Tell your doctor right away if any of these||
0833|106|S|serious side effects occur: vision problems, eye pain.||
0833|107|S|   This medication may mask the signs of an eye/ear infection. It||
0833|108|S|may also put you at greater risk of developing an eye/ear||
0833|109|S|infection, especially with prolonged use. Report any new or||
0833|110|S|worsening symptoms such as eye/ear discharge/swelling/redness,||
0833|111|S|vision/hearing problems, or no improvement of your current||
0833|112|S|eye/ear condition. Your doctor will need to adjust your||
0833|113|S|treatment.||
0833|114|S|   Tell your doctor right away if you have any serious side||
0833|115|S|effects, including: headache, dizziness.||
0833|116|S|   A very serious allergic reaction to this drug is rare.||
0833|117|S|However, get medical help right away if you notice any symptoms||
0833|118|S|of a serious allergic reaction, including: rash, itching/swelling||
0833|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0833|120|S|breathing.||
0833|121|S|   This is not a complete list of possible side effects. If you||
0833|122|S|notice other effects not listed above, contact your doctor or||
0833|123|S|pharmacist.||
0833|124|S|   In the US -||
0833|125|S|   Call your doctor for medical advice about side effects. You||
0833|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0833|127|S|www.fda.gov/medwatch.||
0833|128|S|   In Canada - Call your doctor for medical advice about side||
0833|129|S|effects. You may report side effects to Health Canada at||
0833|130|S|1-866-234-2345.||
0833|131|B|||
0833|132|P|PRECAUTIONS:  Before using dexamethasone, tell your doctor or||
0833|133|P|pharmacist if you are allergic to it; or if you have any other||
0833|134|P|allergies. This product may contain inactive ingredients (such as||
0833|135|P|sulfites found in some brands), which can cause allergic||
0833|136|P|reactions or other problems. Talk to your pharmacist for more||
0833|137|P|details.||
0833|138|P|   Before using this medication, tell your doctor or pharmacist||
0833|139|P|your medical history, especially of: eye infections, recent eye||
0833|140|P|surgery, cataracts, glaucoma (open-angle type), severe||
0833|141|P|nearsightedness (myopia), diabetes, other ear problems (such as a||
0833|142|P|hole in your eardrum, ear infections).||
0833|143|P|   After you apply this drug in the eyes, your vision may become||
0833|144|P|temporarily blurred or unstable. Do not drive, use machinery, or||
0833|145|P|do anything that needs clear vision until you can do it safely.||
0833|146|P|   Before having surgery, tell your doctor or dentist about all||
0833|147|P|the products you use (including prescription drugs,||
0833|148|P|nonprescription drugs, and herbal products).||
0833|149|P|   If you develop a new eye infection or injury, or require eye||
0833|150|P|surgery, ask your doctor if you should continue to use your||
0833|151|P|current bottle of dexamethasone eye drops or start a new bottle.||
0833|152|P|   During pregnancy, this medication should be used only when||
0833|153|P|clearly needed. Discuss the risks and benefits with your doctor.||
0833|154|P|   It is unknown if this medication passes into breast milk.||
0833|155|P|Consult your doctor before breastfeeding.||
0833|156|B|||
0833|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0833|158|I|medications work or increase your risk for serious side effects.||
0833|159|I|This document does not contain all possible drug interactions.||
0833|160|I|Keep a list of all the products you use (including||
0833|161|I|prescription/nonprescription drugs and herbal products) and share||
0833|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
0833|163|I|the dosage of any medicines without your doctor's approval.||
0833|164|B|||
0833|165|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0833|166|O|has overdosed and has serious symptoms such as passing out or||
0833|167|O|trouble breathing, call 911. Otherwise, call a poison control||
0833|168|O|center right away. US residents can call 1-800-222-1222. Canada||
0833|169|O|residents can call 1-844-764-7669.||
0833|170|B|||
0833|171|N|NOTES:  Do not share this medication with others.||
0833|172|N|   This medication has been prescribed for your current condition||
0833|173|N|only. Do not use it later for another condition unless told to do||
0833|174|N|so by your doctor. A different medication may be necessary in||
0833|175|N|that case.||
0833|176|N|   Lab and/or medical tests (such as eye exams, measurement of||
0833|177|N|the pressure inside the eyes, ear exams) may be done while you||
0833|178|N|are using this medication. Keep all medical and lab appointments.||
0833|179|N|Consult your doctor for more details.||
0833|180|B|||
0833|181|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0833|182|D|If it is near the time of the next dose, skip the missed dose.||
0833|183|D|Use your next dose at the regular time. Do not double the dose to||
0833|184|D|catch up.||
0833|185|B|||
0833|186|R|STORAGE:  Different brands of this medication have different||
0833|187|R|storage needs. Check the product package for instructions on how||
0833|188|R|to store your brand, or ask your pharmacist. Keep the bottle||
0833|189|R|upright. Keep all medications away from children and pets.||
0833|190|R|   Do not flush medications down the toilet or pour them into a||
0833|191|R|drain unless instructed to do so. Properly discard this product||
0833|192|R|when it is expired or no longer needed. Consult your pharmacist||
0833|193|R|or local waste disposal company.||
0833|194|B|||
0833|195|A|Information last revised November 2024.||
0833|196|A|Copyright(c) 2025 First Databank, Inc.||
0833|197|B|||
0834|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0834|002|Z|does NOT have all possible information about this product. This||
0834|003|Z|information does not assure that this product is safe, effective,||
0834|004|Z|or appropriate for you. This information is not individual||
0834|005|Z|medical advice and does not substitute for the advice of your||
0834|006|Z|health care professional. Always ask your health care||
0834|007|Z|professional for complete information about this product and your||
0834|008|Z|specific health needs.||
0834|009|B|||
0834|010|T|LOTEPREDNOL 0.2% SUSPENSION - OPHTHALMIC||
0834|011|F|(LOE-te-PRED-nol)||
0834|012|B|||
0834|013|C|COMMON BRAND NAME(S): Alrex||
0834|014|B|||
0834|015|U|USES:  This medication is used to temporarily relieve seasonal||
0834|016|U|allergy symptoms of the eyes such as swelling, redness, and||
0834|017|U|itching. Loteprednol belongs to a class of drugs known as||
0834|018|U|corticosteroids.||
0834|019|B|||
0834|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0834|021|H|directed by your doctor, usually 4 times a day.||
0834|022|H|   If you wear contact lenses, ask your doctor if you should wear||
0834|023|H|them during treatment with this medicine. You should not wear||
0834|024|H|contact lenses if your eyes are red. Sterilize contact lenses||
0834|025|H|according to the manufacturer's directions, and check with your||
0834|026|H|doctor before you begin using them again.||
0834|027|H|   If your doctor does approve the wearing of contact lenses||
0834|028|H|during treatment with this medication, remove the lenses before||
0834|029|H|using the eye drops. The preservative in this product may be||
0834|030|H|absorbed by contact lenses. Wait at least 10 to 15 minutes after||
0834|031|H|each dose of the eye drop before wearing the lenses again.||
0834|032|H|   To apply eye drops, wash your hands first. Shake the bottle||
0834|033|H|well before using. To avoid contamination, do not touch the||
0834|034|H|dropper tip or let it touch your eye or any other surface.||
0834|035|H|   Tilt your head back, look upward, and pull down the lower||
0834|036|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0834|037|H|and place 1 drop into the pouch. Look downward and gently close||
0834|038|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0834|039|H|your eye (near the nose) and apply gentle pressure. This will||
0834|040|H|prevent the medication from draining out. Try not to blink and do||
0834|041|H|not rub your eye. Repeat these steps for your other eye if so||
0834|042|H|directed and if your dose is for more than 1 drop.||
0834|043|H|   Do not rinse the dropper. Replace the dropper cap after each||
0834|044|H|use.||
0834|045|H|   If you are using another kind of eye medication (for example,||
0834|046|H|other drops or ointments), wait at least 5 to 10 minutes before||
0834|047|H|applying other medications. Use eye drops before eye ointments to||
0834|048|H|allow the drops to enter the eye.||
0834|049|H|   Wait several minutes for your vision to clear before driving||
0834|050|H|or operating machinery.||
0834|051|H|   Use this medication regularly in order to get the most benefit||
0834|052|H|from it. To help you remember, use it at the same times each day.||
0834|053|H|   The dosage and length of treatment are based on your medical||
0834|054|H|condition and response to treatment. Do not use this medication||
0834|055|H|more often or for longer than prescribed because doing so may||
0834|056|H|increase your risk of side effects.||
0834|057|H|   Continue to use this medication for the full time prescribed.||
0834|058|H|Do not stop using this medication without consulting your doctor.||
0834|059|H|Some conditions may become worse when the drug is suddenly||
0834|060|H|stopped. Your dose may need to be gradually decreased.||
0834|061|H|   Do not use this product if it becomes contaminated (for||
0834|062|H|example, drops turn a dark color). Use of contaminated eye||
0834|063|H|medication can cause infection, serious damage to the eye, and||
0834|064|H|loss of vision. Contact your doctor or pharmacist for more||
0834|065|H|information.||
0834|066|H|   Tell your doctor if your condition does not get better after 2||
0834|067|H|days or if it gets worse.||
0834|068|B|||
0834|069|S|SIDE EFFECTS:  Stinging/burning of the eyes for 1 to 2 minutes||
0834|070|S|and temporary blurred vision may occur when you apply this||
0834|071|S|medication. If any of these effects last or get worse, tell your||
0834|072|S|doctor or pharmacist promptly.||
0834|073|S|   Remember that this medication has been prescribed because your||
0834|074|S|doctor has judged that the benefit to you is greater than the||
0834|075|S|risk of side effects. Many people using this medication do not||
0834|076|S|have serious side effects.||
0834|077|S|   Use of this medication for prolonged periods or in high doses||
0834|078|S|may cause serious eye problems (such as high pressure inside the||
0834|079|S|eyes and cataracts). Tell your doctor right away if any of these||
0834|080|S|serious side effects occur: vision problems, eye pain.||
0834|081|S|   This medication may mask the signs of an eye infection. It may||
0834|082|S|also put you at greater risk of developing an eye infection,||
0834|083|S|especially with prolonged use. Report any new or worsening||
0834|084|S|symptoms such as eye discharge/swelling/redness, vision problems,||
0834|085|S|or no improvement of your current eye condition. Your doctor will||
0834|086|S|need to adjust your treatment.||
0834|087|S|   Tell your doctor right away if you have any serious side||
0834|088|S|effects, including: headache, dizziness.||
0834|089|S|   A very serious allergic reaction to this drug is rare.||
0834|090|S|However, get medical help right away if you notice any symptoms||
0834|091|S|of a serious allergic reaction, including: rash, itching/swelling||
0834|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0834|093|S|breathing.||
0834|094|S|   This is not a complete list of possible side effects. If you||
0834|095|S|notice other effects not listed above, contact your doctor or||
0834|096|S|pharmacist.||
0834|097|S|   In the US -||
0834|098|S|   Call your doctor for medical advice about side effects. You||
0834|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0834|100|S|www.fda.gov/medwatch.||
0834|101|S|   In Canada - Call your doctor for medical advice about side||
0834|102|S|effects. You may report side effects to Health Canada at||
0834|103|S|1-866-234-2345.||
0834|104|B|||
0834|105|P|PRECAUTIONS:  Before using loteprednol, tell your doctor or||
0834|106|P|pharmacist if you are allergic to it; or if you have any other||
0834|107|P|allergies. This product may contain inactive ingredients, which||
0834|108|P|can cause allergic reactions or other problems. Talk to your||
0834|109|P|pharmacist for more details.||
0834|110|P|   Before using this medication, tell your doctor or pharmacist||
0834|111|P|your medical history, especially of: eye infections, recent eye||
0834|112|P|surgery, cataracts, glaucoma (open-angle type), severe||
0834|113|P|nearsightedness (myopia), diabetes.||
0834|114|P|   After you apply this drug, your vision may become temporarily||
0834|115|P|blurred. Do not drive, use machinery, or do anything that needs||
0834|116|P|clear vision until you can do it safely.||
0834|117|P|   Before having surgery, tell your doctor or dentist about all||
0834|118|P|the products you use (including prescription drugs,||
0834|119|P|nonprescription drugs, and herbal products).||
0834|120|P|   If you develop a new eye infection or injury, or require eye||
0834|121|P|surgery, ask your doctor if you should continue to use your||
0834|122|P|current bottle of loteprednol eye drops or start a new bottle.||
0834|123|P|   During pregnancy, this medication should be used only when||
0834|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
0834|125|P|   It is unknown if this medication passes into breast milk.||
0834|126|P|Consult your doctor before breastfeeding.||
0834|127|B|||
0834|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0834|129|I|medications work or increase your risk for serious side effects.||
0834|130|I|This document does not contain all possible drug interactions.||
0834|131|I|Keep a list of all the products you use (including||
0834|132|I|prescription/nonprescription drugs and herbal products) and share||
0834|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
0834|134|I|the dosage of any medicines without your doctor's approval.||
0834|135|B|||
0834|136|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0834|137|O|has overdosed and has serious symptoms such as passing out or||
0834|138|O|trouble breathing, call 911. Otherwise, call a poison control||
0834|139|O|center right away. US residents can call 1-800-222-1222. Canada||
0834|140|O|residents can call 1-844-764-7669.||
0834|141|B|||
0834|142|N|NOTES:  Do not share this medication with others.||
0834|143|N|   Avoid substances such as pollen and other irritants that may||
0834|144|N|trigger an allergic reaction. Applying cold compresses over the||
0834|145|N|eyes and using lubricating eye drops may also help reduce||
0834|146|N|allergic eye symptoms.||
0834|147|N|   This medication has been prescribed for your current condition||
0834|148|N|only. Do not use it later for another eye condition unless told||
0834|149|N|to do so by your doctor. A different medication may be necessary||
0834|150|N|in that case.||
0834|151|N|   With long-term use, lab and/or medical tests (such as eye||
0834|152|N|exams, measurement of the pressure inside the eyes) may be done||
0834|153|N|while you are using this medication. Keep all medical and lab||
0834|154|N|appointments. Consult your doctor for more details.||
0834|155|B|||
0834|156|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0834|157|D|If it is near the time of the next dose, skip the missed dose.||
0834|158|D|Use your next dose at the regular time. Do not double the dose to||
0834|159|D|catch up.||
0834|160|B|||
0834|161|R|STORAGE:  Store at room temperature. Do not freeze. Keep bottle||
0834|162|R|upright when not in use. Keep all medications away from children||
0834|163|R|and pets.||
0834|164|R|   Do not flush medications down the toilet or pour them into a||
0834|165|R|drain unless instructed to do so. Properly discard this product||
0834|166|R|when it is expired or no longer needed. Consult your pharmacist||
0834|167|R|or local waste disposal company.||
0834|168|B|||
0834|169|A|Information last revised October 2024.||
0834|170|A|Copyright(c) 2025 First Databank, Inc.||
0834|171|B|||
0835|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0835|002|Z|does NOT have all possible information about this product. This||
0835|003|Z|information does not assure that this product is safe, effective,||
0835|004|Z|or appropriate for you. This information is not individual||
0835|005|Z|medical advice and does not substitute for the advice of your||
0835|006|Z|health care professional. Always ask your health care||
0835|007|Z|professional for complete information about this product and your||
0835|008|Z|specific health needs.||
0835|009|B|||
0835|010|T|LOTEPREDNOL 0.5% SUSPENSION - OPHTHALMIC||
0835|011|F|(LOE-te-PRED-nol)||
0835|012|B|||
0835|013|C|COMMON BRAND NAME(S): Lotemax||
0835|014|B|||
0835|015|U|USES:  This medication is used to treat certain eye conditions||
0835|016|U|due to inflammation or injury. It is also used after eye surgery.||
0835|017|U|Loteprednol works by relieving symptoms such as swelling,||
0835|018|U|redness, and itching. It belongs to a class of drugs known as||
0835|019|U|corticosteroids.||
0835|020|B|||
0835|021|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0835|022|H|directed by your doctor, usually 4 times a day.||
0835|023|H|   Unless otherwise directed by your doctor, do not wear contact||
0835|024|H|lenses while you are using this medicine. Sterilize contact||
0835|025|H|lenses according to the manufacturer's directions, and check with||
0835|026|H|your doctor before you begin using them again.||
0835|027|H|   If your doctor does approve the wearing of contact lenses||
0835|028|H|during treatment with this medication, remove the lenses before||
0835|029|H|using the eye drops. The preservative in this product may be||
0835|030|H|absorbed by contact lenses. Wait at least 15 minutes after each||
0835|031|H|dose of the eye drop before wearing the lenses again.||
0835|032|H|   To apply eye drops, wash your hands first. Shake the bottle||
0835|033|H|well before using. To avoid contamination, do not touch the||
0835|034|H|dropper tip or let it touch your eye or any other surface.||
0835|035|H|   Tilt your head back, look upward, and pull down the lower||
0835|036|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0835|037|H|and place 1 drop into the pouch. Look downward and gently close||
0835|038|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
0835|039|H|your eye (near the nose) and apply gentle pressure. This will||
0835|040|H|prevent the medication from draining out. Try not to blink and do||
0835|041|H|not rub your eye. Repeat these steps for your other eye if so||
0835|042|H|directed and if your dose is for more than 1 drop.||
0835|043|H|   Do not rinse the dropper. Replace the dropper cap after each||
0835|044|H|use.||
0835|045|H|   If you are using another kind of eye medication (for example,||
0835|046|H|other drops or ointments), wait at least 5 to 10 minutes before||
0835|047|H|applying other medications. Use eye drops before eye ointments to||
0835|048|H|allow the drops to enter the eye.||
0835|049|H|   Wait several minutes for your vision to clear before driving||
0835|050|H|or operating machinery.||
0835|051|H|   Use this medication regularly in order to get the most benefit||
0835|052|H|from it. To help you remember, use it at the same time(s) each||
0835|053|H|day.||
0835|054|H|   The dosage and length of treatment are based on your medical||
0835|055|H|condition and response to treatment. Do not use this medication||
0835|056|H|more often or for longer than prescribed because doing so may||
0835|057|H|increase your risk of side effects.||
0835|058|H|   Continue to use this medication for the full time prescribed.||
0835|059|H|Do not stop using this medication without consulting your doctor.||
0835|060|H|Some conditions may become worse when the drug is suddenly||
0835|061|H|stopped. Your dose may need to be gradually decreased.||
0835|062|H|   Do not use this product if it becomes contaminated (for||
0835|063|H|example, drops turn a dark color). Use of contaminated eye||
0835|064|H|medication can cause infection, serious damage to the eye, and||
0835|065|H|loss of vision. Contact your doctor or pharmacist for more||
0835|066|H|information.||
0835|067|H|   Tell your doctor if your condition does not get better after 2||
0835|068|H|days or if it gets worse.||
0835|069|B|||
0835|070|S|SIDE EFFECTS:  Stinging/burning of the eyes for 1 to 2 minutes||
0835|071|S|and temporary blurred vision may occur when you apply this||
0835|072|S|medication. If any of these effects last or get worse, tell your||
0835|073|S|doctor or pharmacist promptly.||
0835|074|S|   Remember that this medication has been prescribed because your||
0835|075|S|doctor has judged that the benefit to you is greater than the||
0835|076|S|risk of side effects. Many people using this medication do not||
0835|077|S|have serious side effects.||
0835|078|S|   Use of this medication for prolonged periods or in high doses||
0835|079|S|may cause serious eye problems (such as high pressure inside the||
0835|080|S|eyes and cataracts). Tell your doctor right away if any of these||
0835|081|S|serious side effects occur: vision problems, eye pain.||
0835|082|S|   This medication may mask the signs of an eye infection. It may||
0835|083|S|also put you at greater risk of developing an eye infection,||
0835|084|S|especially with prolonged use. Report any new or worsening||
0835|085|S|symptoms such as eye discharge/swelling/redness, vision problems,||
0835|086|S|or no improvement of your current eye condition. Your doctor will||
0835|087|S|need to adjust your treatment.||
0835|088|S|   Tell your doctor right away if you have any serious side||
0835|089|S|effects, including: headache, dizziness.||
0835|090|S|   A very serious allergic reaction to this drug is rare.||
0835|091|S|However, get medical help right away if you notice any symptoms||
0835|092|S|of a serious allergic reaction, including: rash, itching/swelling||
0835|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0835|094|S|breathing.||
0835|095|S|   This is not a complete list of possible side effects. If you||
0835|096|S|notice other effects not listed above, contact your doctor or||
0835|097|S|pharmacist.||
0835|098|S|   In the US -||
0835|099|S|   Call your doctor for medical advice about side effects. You||
0835|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0835|101|S|www.fda.gov/medwatch.||
0835|102|S|   In Canada - Call your doctor for medical advice about side||
0835|103|S|effects. You may report side effects to Health Canada at||
0835|104|S|1-866-234-2345.||
0835|105|B|||
0835|106|P|PRECAUTIONS:  Before using loteprednol, tell your doctor or||
0835|107|P|pharmacist if you are allergic to it; or if you have any other||
0835|108|P|allergies. This product may contain inactive ingredients, which||
0835|109|P|can cause allergic reactions or other problems. Talk to your||
0835|110|P|pharmacist for more details.||
0835|111|P|   Before using this medication, tell your doctor or pharmacist||
0835|112|P|your medical history, especially of: eye infections, cataracts,||
0835|113|P|glaucoma (open-angle type), severe nearsightedness (myopia),||
0835|114|P|diabetes.||
0835|115|P|   After you apply this drug, your vision may become temporarily||
0835|116|P|blurred. Do not drive, use machinery, or do anything that needs||
0835|117|P|clear vision until you can do it safely.||
0835|118|P|   Before having surgery, tell your doctor or dentist about all||
0835|119|P|the products you use (including prescription drugs,||
0835|120|P|nonprescription drugs, and herbal products).||
0835|121|P|   If you develop a new eye infection or injury, or require eye||
0835|122|P|surgery, ask your doctor if you should continue to use your||
0835|123|P|current bottle of loteprednol eye drops or start a new bottle.||
0835|124|P|   During pregnancy, this medication should be used only when||
0835|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
0835|126|P|   It is unknown if this medication passes into breast milk.||
0835|127|P|Consult your doctor before breastfeeding.||
0835|128|B|||
0835|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0835|130|I|medications work or increase your risk for serious side effects.||
0835|131|I|This document does not contain all possible drug interactions.||
0835|132|I|Keep a list of all the products you use (including||
0835|133|I|prescription/nonprescription drugs and herbal products) and share||
0835|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
0835|135|I|the dosage of any medicines without your doctor's approval.||
0835|136|B|||
0835|137|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0835|138|O|has overdosed and has serious symptoms such as passing out or||
0835|139|O|trouble breathing, call 911. Otherwise, call a poison control||
0835|140|O|center right away. US residents can call 1-800-222-1222. Canada||
0835|141|O|residents can call 1-844-764-7669.||
0835|142|B|||
0835|143|N|NOTES:  Do not share this medication with others.||
0835|144|N|   This medication has been prescribed for your current condition||
0835|145|N|only. Do not use it later for another eye condition unless told||
0835|146|N|to do so by your doctor. A different medication may be necessary||
0835|147|N|in that case.||
0835|148|N|   Lab and/or medical tests (such as eye exams, measurement of||
0835|149|N|the pressure inside the eyes) may be done while you are using||
0835|150|N|this medication. Keep all medical and lab appointments. Consult||
0835|151|N|your doctor for more details.||
0835|152|B|||
0835|153|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0835|154|D|If it is near the time of the next dose, skip the missed dose.||
0835|155|D|Use your next dose at the regular time. Do not double the dose to||
0835|156|D|catch up.||
0835|157|B|||
0835|158|R|STORAGE:  Store at room temperature. Do not freeze. Keep bottle||
0835|159|R|upright when not in use. Keep all medications away from children||
0835|160|R|and pets.||
0835|161|R|   Do not flush medications down the toilet or pour them into a||
0835|162|R|drain unless instructed to do so. Properly discard this product||
0835|163|R|when it is expired or no longer needed. Consult your pharmacist||
0835|164|R|or local waste disposal company.||
0835|165|B|||
0835|166|A|Information last revised October 2024.||
0835|167|A|Copyright(c) 2025 First Databank, Inc.||
0835|168|B|||
0836|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0836|002|Z|does NOT have all possible information about this product. This||
0836|003|Z|information does not assure that this product is safe, effective,||
0836|004|Z|or appropriate for you. This information is not individual||
0836|005|Z|medical advice and does not substitute for the advice of your||
0836|006|Z|health care professional. Always ask your health care||
0836|007|Z|professional for complete information about this product and your||
0836|008|Z|specific health needs.||
0836|009|B|||
0836|010|T|SULFACETAMIDE DROPS - OPHTHALMIC||
0836|011|F|(SUL-fa-SEET-a-mide)||
0836|012|B|||
0836|013|C|COMMON BRAND NAME(S): Bleph-10||
0836|014|B|||
0836|015|U|USES:  This medication is used to treat bacterial eye infections||
0836|016|U|(such as conjunctivitis). It belongs to a class of drugs known as||
0836|017|U|sulfa antibiotics. Sulfacetamide works by stopping the growth of||
0836|018|U|bacteria.||
0836|019|U|   This medication treats only bacterial eye infections. It will||
0836|020|U|not work for other types of eye infections. Unnecessary use or||
0836|021|U|misuse of any antibiotic can lead to its decreased effectiveness.||
0836|022|B|||
0836|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0836|024|H|directed by your doctor, usually every 2 to 3 hours.||
0836|025|H|   Before using, check this product for discoloration. If the||
0836|026|H|product is discolored, do not use the liquid.||
0836|027|H|   To apply eye drops, wash your hands first. To avoid||
0836|028|H|contamination, do not touch the dropper tip or let it touch your||
0836|029|H|eye or any other surface. Use in the eyes only. Do not swallow or||
0836|030|H|inject.||
0836|031|H|   Do not wear contact lenses while you are using this medicine.||
0836|032|H|Sterilize contact lenses according to manufacturer's directions,||
0836|033|H|and check with your doctor before you begin using them again.||
0836|034|H|   Tilt your head back, look upward, and pull down the lower||
0836|035|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0836|036|H|and place one drop into the pouch as directed by your doctor.||
0836|037|H|Look downward, gently close your eyes, and place one finger at||
0836|038|H|the corner of your eye (near the nose). Apply gentle pressure for||
0836|039|H|1 to 2 minutes before opening your eyes. This will prevent the||
0836|040|H|medication from draining out. Try not to blink or rub your eye.||
0836|041|H|Repeat these steps for your other eye if so directed or if your||
0836|042|H|dose is for more than 1 drop. Do not rinse the dropper. Replace||
0836|043|H|the dropper cap after each use.||
0836|044|H|   The dosage is based on your medical condition and response to||
0836|045|H|treatment. Your doctor may direct you to use this medication more||
0836|046|H|often at first, then use it less often as the infection improves.||
0836|047|H|Follow your doctor's directions carefully. Your doctor may direct||
0836|048|H|you to use sulfacetamide drops during the day and the ointment at||
0836|049|H|bedtime.||
0836|050|H|   If you are using another kind of eye medication (such as drops||
0836|051|H|or ointments), wait at least 5 minutes before applying other||
0836|052|H|medications. Use eye drops before eye ointments to allow the||
0836|053|H|drops to enter the eye.||
0836|054|H|   Wait several minutes for your vision to clear before driving||
0836|055|H|or operating machinery.||
0836|056|H|   Use this medication regularly in order to get the most benefit||
0836|057|H|from it. To help you remember, use it at the same times each day.||
0836|058|H|Continue to use this medication for the full time prescribed,||
0836|059|H|even if symptoms disappear after a few days. Stopping the||
0836|060|H|medication too early may result in a return of the infection.||
0836|061|H|   Tell your doctor if your condition lasts or gets worse.||
0836|062|B|||
0836|063|S|SIDE EFFECTS:  Eye stinging/burning/redness and temporary blurred||
0836|064|S|vision may occur. If any of these effects last or get worse, tell||
0836|065|S|your doctor or pharmacist promptly.||
0836|066|S|   Remember that this medication has been prescribed because your||
0836|067|S|doctor has judged that the benefit to you is greater than the||
0836|068|S|risk of side effects. Many people using this medication do not||
0836|069|S|have serious side effects.||
0836|070|S|   Use of this medication for prolonged or repeated periods may||
0836|071|S|result in other types of eye infections, including fungal||
0836|072|S|infections. Stop using this medication and contact your doctor if||
0836|073|S|you notice new or worsening eye symptoms (such as pain, swelling,||
0836|074|S|thick discharge or pus).||
0836|075|S|   Rarely, sulfacetamide products used in the eye may be absorbed||
0836|076|S|and may cause serious side effects. Stop using this product and||
0836|077|S|tell your doctor right away if you have any serious side effects,||
0836|078|S|including: aching/swollen joints, rash on nose and cheeks, signs||
0836|079|S|of infection (such as sore throat that doesn't go away, fever,||
0836|080|S|chills), signs of anemia (such as unusual tiredness/weakness,||
0836|081|S|rapid breathing, fast heartbeat), unusual bleeding/bruising,||
0836|082|S|signs of liver problems (such as nausea that doesn't stop, dark||
0836|083|S|urine, yellowing eyes/skin, stomach/abdominal pain, vomiting),||
0836|084|S|mouth sores.||
0836|085|S|   A very serious allergic reaction to this drug is rare.||
0836|086|S|However, get medical help right away if you notice any symptoms||
0836|087|S|of a serious allergic reaction, including: rash, itching/swelling||
0836|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0836|089|S|breathing.||
0836|090|S|   This is not a complete list of possible side effects. If you||
0836|091|S|notice other effects not listed above, contact your doctor or||
0836|092|S|pharmacist.||
0836|093|S|   In the US -||
0836|094|S|   Call your doctor for medical advice about side effects. You||
0836|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0836|096|S|www.fda.gov/medwatch.||
0836|097|S|   In Canada - Call your doctor for medical advice about side||
0836|098|S|effects. You may report side effects to Health Canada at||
0836|099|S|1-866-234-2345.||
0836|100|B|||
0836|101|P|PRECAUTIONS:  Before using sulfacetamide, tell your doctor or||
0836|102|P|pharmacist if you are allergic to it; or to other sulfa||
0836|103|P|antibiotics (such as sulfamethoxazole); or if you have any other||
0836|104|P|allergies. This product may contain inactive ingredients, which||
0836|105|P|can cause allergic reactions or other problems. Talk to your||
0836|106|P|pharmacist for more details.||
0836|107|P|   Before using this medication, tell your doctor or pharmacist||
0836|108|P|your medical history, especially of: contact lens use.||
0836|109|P|   After you apply this drug, your vision may become temporarily||
0836|110|P|blurred. Do not drive, use machinery, or do anything that needs||
0836|111|P|clear vision until you can do it safely.||
0836|112|P|   Before having surgery, tell your doctor or dentist about all||
0836|113|P|the products you use (including prescription drugs,||
0836|114|P|nonprescription drugs, and herbal products).||
0836|115|P|   During pregnancy, this medication should be used only when||
0836|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
0836|117|P|   It is unknown if this drug passes into breast milk. Consult||
0836|118|P|your doctor before breastfeeding.||
0836|119|B|||
0836|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0836|121|I|medications work or increase your risk for serious side effects.||
0836|122|I|This document does not contain all possible drug interactions.||
0836|123|I|Keep a list of all the products you use (including||
0836|124|I|prescription/nonprescription drugs and herbal products) and share||
0836|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
0836|126|I|the dosage of any medicines without your doctor's approval.||
0836|127|I|   Some products that may interact with this drug are: silver||
0836|128|I|preparations for the eye (such as silver nitrate).||
0836|129|B|||
0836|130|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0836|131|O|has overdosed and has serious symptoms such as passing out or||
0836|132|O|trouble breathing, call 911. Otherwise, call a poison control||
0836|133|O|center right away. US residents can call 1-800-222-1222. Canada||
0836|134|O|residents can call 1-844-764-7669.||
0836|135|B|||
0836|136|N|NOTES:  Do not share this medication with others.||
0836|137|N|   This medication has been prescribed for your current condition||
0836|138|N|only. Do not use it later for another infection unless your||
0836|139|N|doctor tells you to.||
0836|140|B|||
0836|141|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0836|142|D|If it is near the time of the next dose, skip the missed dose.||
0836|143|D|Use your next dose at the regular time. Do not double the dose to||
0836|144|D|catch up.||
0836|145|B|||
0836|146|R|STORAGE:  Different brands of this medication have different||
0836|147|R|storage needs. Check the product package for instructions on how||
0836|148|R|to store your brand, or ask your pharmacist. Keep all medications||
0836|149|R|away from children and pets.||
0836|150|R|   Do not flush medications down the toilet or pour them into a||
0836|151|R|drain unless instructed to do so. Properly discard this product||
0836|152|R|when it is expired or no longer needed. Consult your pharmacist||
0836|153|R|or local waste disposal company.||
0836|154|B|||
0836|155|A|Information last revised April 2025.||
0836|156|A|Copyright(c) 2025 First Databank, Inc.||
0836|157|B|||
0837|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0837|002|Z|does NOT have all possible information about this product. This||
0837|003|Z|information does not assure that this product is safe, effective,||
0837|004|Z|or appropriate for you. This information is not individual||
0837|005|Z|medical advice and does not substitute for the advice of your||
0837|006|Z|health care professional. Always ask your health care||
0837|007|Z|professional for complete information about this product and your||
0837|008|Z|specific health needs.||
0837|009|B|||
0837|010|T|SULFACETAMIDE OINTMENT - OPHTHALMIC||
0837|011|F|(SUL-fa-SEET-a-mide)||
0837|012|B|||
0837|013|C|COMMON BRAND NAME(S): Cetamide||
0837|014|B|||
0837|015|U|USES:  This medication is used to treat bacterial eye infections||
0837|016|U|(such as conjunctivitis). It belongs to a class of drugs known as||
0837|017|U|sulfa antibiotics. Sulfacetamide works by stopping the growth of||
0837|018|U|bacteria.||
0837|019|U|   This medication treats only bacterial eye infections. It will||
0837|020|U|not work for other types of eye infections. Unnecessary use or||
0837|021|U|misuse of any antibiotic can lead to its decreased effectiveness.||
0837|022|B|||
0837|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0837|024|H|directed by your doctor, usually every 3 to 4 hours.||
0837|025|H|   To apply eye ointment, wash your hands first. To avoid||
0837|026|H|contamination, do not touch the tip of the tube or let it touch||
0837|027|H|your eye or any other surface. Apply to the eyes only. Do not||
0837|028|H|swallow or inject.||
0837|029|H|   Do not wear contact lenses while you are using this medicine.||
0837|030|H|Sterilize contact lenses according to manufacturer's directions,||
0837|031|H|and check with your doctor before you begin using them again.||
0837|032|H|   To apply eye ointments, tilt your head back, look up, and||
0837|033|H|gently pull down the lower eyelid to make a pouch. Place a||
0837|034|H|half-inch (1.3 centimeters) strip of ointment into the pouch.||
0837|035|H|Gently close the eye and roll the eyeball in all directions to||
0837|036|H|spread the medication. Try not to blink and do not rub the eye.||
0837|037|H|Repeat these steps for your other eye if so directed. Wipe the||
0837|038|H|tip of the ointment tube with a clean tissue to remove extra||
0837|039|H|medication before recapping it.||
0837|040|H|   The dosage is based on your medical condition and response to||
0837|041|H|treatment. Your doctor may direct you to use this medication more||
0837|042|H|often at first, then use it less often as the infection improves.||
0837|043|H|Follow your doctor's directions exactly. Your doctor may direct||
0837|044|H|you to use sulfacetamide drops during the day and the ointment at||
0837|045|H|bedtime.||
0837|046|H|   If you are using another kind of eye medication (such as drops||
0837|047|H|or ointments), wait at least 5 minutes before applying other||
0837|048|H|medications. Use eye drops before eye ointments to allow the||
0837|049|H|drops to enter the eye.||
0837|050|H|   Wait several minutes for your vision to clear before driving||
0837|051|H|or operating machinery.||
0837|052|H|   Use this medication regularly in order to get the most benefit||
0837|053|H|from it. To help you remember, use it at the same times each day.||
0837|054|H|Continue to use this medication for the full time prescribed,||
0837|055|H|even if symptoms disappear after a few days. Stopping the||
0837|056|H|medication too early may result in a return of the infection.||
0837|057|H|   Tell your doctor if your condition lasts or gets worse.||
0837|058|B|||
0837|059|S|SIDE EFFECTS:  Eye stinging/burning/redness and temporary blurred||
0837|060|S|vision may occur. If any of these effects last or get worse, tell||
0837|061|S|your doctor or pharmacist promptly.||
0837|062|S|   Remember that this medication has been prescribed because your||
0837|063|S|doctor has judged that the benefit to you is greater than the||
0837|064|S|risk of side effects. Many people using this medication do not||
0837|065|S|have serious side effects.||
0837|066|S|   Use of this medication for prolonged or repeated periods may||
0837|067|S|result in other types of eye infections, including fungal||
0837|068|S|infections. Stop using this medication and contact your doctor if||
0837|069|S|you notice new or worsening eye symptoms (such as pain, swelling,||
0837|070|S|thick discharge or pus).||
0837|071|S|   Rarely, sulfacetamide products used in the eye may be absorbed||
0837|072|S|and may cause serious side effects. Stop using this product and||
0837|073|S|tell your doctor right away if you have any serious side effects,||
0837|074|S|including: aching/swollen joints, rash on nose and cheeks, signs||
0837|075|S|of infection (such as sore throat that doesn't go away, fever,||
0837|076|S|chills), signs of anemia (such as unusual tiredness/weakness,||
0837|077|S|rapid breathing, fast heartbeat), unusual bleeding/bruising,||
0837|078|S|signs of liver problems (such as nausea that doesn't stop, dark||
0837|079|S|urine, yellowing eyes/skin, stomach/abdominal pain, vomiting),||
0837|080|S|mouth sores.||
0837|081|S|   A very serious allergic reaction to this drug is rare.||
0837|082|S|However, get medical help right away if you notice any symptoms||
0837|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0837|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0837|085|S|breathing.||
0837|086|S|   This is not a complete list of possible side effects. If you||
0837|087|S|notice other effects not listed above, contact your doctor or||
0837|088|S|pharmacist.||
0837|089|S|   In the US -||
0837|090|S|   Call your doctor for medical advice about side effects. You||
0837|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0837|092|S|www.fda.gov/medwatch.||
0837|093|S|   In Canada - Call your doctor for medical advice about side||
0837|094|S|effects. You may report side effects to Health Canada at||
0837|095|S|1-866-234-2345.||
0837|096|B|||
0837|097|P|PRECAUTIONS:  Before using sulfacetamide, tell your doctor or||
0837|098|P|pharmacist if you are allergic to it; or to other sulfa||
0837|099|P|antibiotics (such as sulfamethoxazole); or if you have any other||
0837|100|P|allergies. This product may contain inactive ingredients, which||
0837|101|P|can cause allergic reactions or other problems. Talk to your||
0837|102|P|pharmacist for more details.||
0837|103|P|   Before using this medication, tell your doctor or pharmacist||
0837|104|P|your medical history, especially of: contact lens use.||
0837|105|P|   After you apply this drug, your vision may become temporarily||
0837|106|P|blurred. Do not drive, use machinery, or do anything that needs||
0837|107|P|clear vision until you can do it safely.||
0837|108|P|   Before having surgery, tell your doctor or dentist about all||
0837|109|P|the products you use (including prescription drugs,||
0837|110|P|nonprescription drugs, and herbal products).||
0837|111|P|   During pregnancy, this medication should be used only when||
0837|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
0837|113|P|   It is unknown if this drug passes into breast milk. Consult||
0837|114|P|your doctor before breastfeeding.||
0837|115|B|||
0837|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0837|117|I|medications work or increase your risk for serious side effects.||
0837|118|I|This document does not contain all possible drug interactions.||
0837|119|I|Keep a list of all the products you use (including||
0837|120|I|prescription/nonprescription drugs and herbal products) and share||
0837|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
0837|122|I|the dosage of any medicines without your doctor's approval.||
0837|123|I|   Some products that may interact with this drug are: silver||
0837|124|I|preparations for the eye (such as silver nitrate).||
0837|125|B|||
0837|126|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0837|127|O|has overdosed and has serious symptoms such as passing out or||
0837|128|O|trouble breathing, call 911. Otherwise, call a poison control||
0837|129|O|center right away. US residents can call 1-800-222-1222. Canada||
0837|130|O|residents can call 1-844-764-7669.||
0837|131|B|||
0837|132|N|NOTES:  Do not share this medication with others.||
0837|133|N|   This medication has been prescribed for your current condition||
0837|134|N|only. Do not use it later for another infection unless your||
0837|135|N|doctor tells you to.||
0837|136|B|||
0837|137|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0837|138|D|If it is near the time of the next dose, skip the missed dose.||
0837|139|D|Use your next dose at the regular time. Do not double the dose to||
0837|140|D|catch up.||
0837|141|B|||
0837|142|R|STORAGE:  Different brands of this medication have different||
0837|143|R|storage needs. Check the product package for instructions on how||
0837|144|R|to store your brand, or ask your pharmacist. Keep all medications||
0837|145|R|away from children and pets.||
0837|146|R|   Do not flush medications down the toilet or pour them into a||
0837|147|R|drain unless instructed to do so. Properly discard this product||
0837|148|R|when it is expired or no longer needed. Consult your pharmacist||
0837|149|R|or local waste disposal company.||
0837|150|B|||
0837|151|A|Information last revised April 2025.||
0837|152|A|Copyright(c) 2025 First Databank, Inc.||
0837|153|B|||
0838|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0838|002|Z|does NOT have all possible information about this product. This||
0838|003|Z|information does not assure that this product is safe, effective,||
0838|004|Z|or appropriate for you. This information is not individual||
0838|005|Z|medical advice and does not substitute for the advice of your||
0838|006|Z|health care professional. Always ask your health care||
0838|007|Z|professional for complete information about this product and your||
0838|008|Z|specific health needs.||
0838|009|B|||
0838|010|T|SITAGLIPTIN - ORAL||
0838|011|F|(sit-a-GLIP-tin)||
0838|012|B|||
0838|013|C|COMMON BRAND NAME(S): Brynovin, Januvia, Zituvio||
0838|014|B|||
0838|015|U|USES:  Sitagliptin is used with a proper diet and exercise||
0838|016|U|program and possibly with other medications to control high blood||
0838|017|U|sugar. It is used in people with type 2 diabetes. Controlling||
0838|018|U|high blood sugar helps prevent kidney damage, blindness, nerve||
0838|019|U|problems, loss of limbs, and sexual function problems. Proper||
0838|020|U|control of diabetes may also lessen your risk of a heart attack||
0838|021|U|or stroke.||
0838|022|U|   Sitagliptin is a diabetes drug that works by increasing levels||
0838|023|U|of natural substances called incretins. Incretins help to control||
0838|024|U|blood sugar by increasing insulin release, especially after a||
0838|025|U|meal. They also decrease the amount of sugar your liver makes.||
0838|026|B|||
0838|027|H|HOW TO USE:  Read the Medication Guide provided by your||
0838|028|H|pharmacist before you start using sitagliptin and each time you||
0838|029|H|get a refill. If you have any questions, ask your doctor or||
0838|030|H|pharmacist.||
0838|031|H|   Take this medication by mouth with or without food as directed||
0838|032|H|by your doctor, usually once daily.||
0838|033|H|   If you are using the liquid form of this medication, carefully||
0838|034|H|measure the dose using a special measuring device/spoon. Do not||
0838|035|H|use a household spoon because you may not get the correct dose.||
0838|036|H|   The dosage is based on your medical condition and response to||
0838|037|H|treatment. Take this medication regularly to get the most benefit||
0838|038|H|from it. To help you remember, take it at the same time each day.||
0838|039|H|Carefully follow the medication treatment plan, meal plan, and||
0838|040|H|exercise program your doctor has recommended.||
0838|041|H|   Check your blood sugar regularly as directed by your doctor.||
0838|042|H|Keep track of the results, and share them with your doctor. Tell||
0838|043|H|your doctor if your blood sugar measurements are too high or too||
0838|044|H|low. Your dosage/treatment may need to be changed.||
0838|045|B|||
0838|046|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0838|047|S|because your doctor has judged that the benefit to you is greater||
0838|048|S|than the risk of side effects. Many people using this medication||
0838|049|S|do not have serious side effects.||
0838|050|S|   Sitagliptin does not usually cause low blood sugar||
0838|051|S|(hypoglycemia). Low blood sugar may occur if this drug is||
0838|052|S|prescribed with other diabetes medications, or if you do not get||
0838|053|S|enough calories from food, or if you do unusually heavy exercise.||
0838|054|S|Talk with your doctor or pharmacist about whether the dose of||
0838|055|S|your other diabetes medication(s) needs to be lowered. Symptoms||
0838|056|S|of low blood sugar include sudden sweating, shaking, fast||
0838|057|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
0838|058|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
0838|059|S|treat low blood sugar. If you don't have these reliable forms of||
0838|060|S|glucose, rapidly raise your blood sugar by eating a quick source||
0838|061|S|of sugar such as table sugar, honey, or candy, or drink fruit||
0838|062|S|juice or non-diet soda. Tell your doctor right away about the||
0838|063|S|reaction and the use of this product. To help prevent low blood||
0838|064|S|sugar, eat meals on a regular schedule, and do not skip meals.||
0838|065|S|Check with your doctor or pharmacist to find out what you should||
0838|066|S|do if you miss a meal.||
0838|067|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0838|068|S|thirst/urination. If these symptoms occur, tell your doctor right||
0838|069|S|away. Your doctor may need to adjust your diabetes medication,||
0838|070|S|exercise program, or diet.||
0838|071|S|   Tell your doctor right away of any serious side effects,||
0838|072|S|including: signs of kidney problems (such as change in the amount||
0838|073|S|of urine), joint pain, unusual skin blisters, signs of heart||
0838|074|S|failure (such as shortness of breath, swelling ankles/feet,||
0838|075|S|unusual tiredness, unusual/sudden weight gain).||
0838|076|S|   Get medical help right away if you have any very serious side||
0838|077|S|effects, including: signs of pancreatitis (such as||
0838|078|S|nausea/vomiting that doesn't stop, loss of appetite, severe||
0838|079|S|stomach/abdominal/back pain).||
0838|080|S|   A very serious allergic reaction to this drug is rare.||
0838|081|S|However, get medical help right away if you notice any symptoms||
0838|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0838|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0838|084|S|breathing.||
0838|085|S|   This is not a complete list of possible side effects. If you||
0838|086|S|notice other effects not listed above, contact your doctor or||
0838|087|S|pharmacist.||
0838|088|S|   In the US -||
0838|089|S|   Call your doctor for medical advice about side effects. You||
0838|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0838|091|S|www.fda.gov/medwatch.||
0838|092|S|   In Canada - Call your doctor for medical advice about side||
0838|093|S|effects. You may report side effects to Health Canada at||
0838|094|S|1-866-234-2345.||
0838|095|B|||
0838|096|P|PRECAUTIONS:  Before taking sitagliptin, tell your doctor or||
0838|097|P|pharmacist if you are allergic to it; or if you have any other||
0838|098|P|allergies. This product may contain inactive ingredients, which||
0838|099|P|can cause allergic reactions or other problems. Talk to your||
0838|100|P|pharmacist for more details.||
0838|101|P|   Before using this medication, tell your doctor or pharmacist||
0838|102|P|your medical history, especially of: kidney disease, heart||
0838|103|P|failure, disease of the pancreas (pancreatitis), stones in your||
0838|104|P|gallbladder (gallstones).||
0838|105|P|   You may experience blurred vision, dizziness, or drowsiness||
0838|106|P|due to extremely low or high blood sugar. Do not drive, use||
0838|107|P|machinery, or do anything that needs alertness or clear vision||
0838|108|P|until you can do it safely.||
0838|109|P|   Limit alcohol while taking this medication because it can||
0838|110|P|increase your risk of developing low blood sugar.||
0838|111|P|   It may be harder to control your blood sugar when your body is||
0838|112|P|stressed (such as due to fever, infection, injury, or surgery).||
0838|113|P|Consult your doctor because increased stress may require a change||
0838|114|P|in your treatment plan, medications, or blood sugar testing.||
0838|115|P|   Before having surgery, tell your doctor or dentist about all||
0838|116|P|the products you use (including prescription drugs,||
0838|117|P|nonprescription drugs, and herbal products).||
0838|118|P|   During pregnancy, this medication should be used only when||
0838|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
0838|120|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
0838|121|P|your doctor for managing your blood sugar while pregnant. Your||
0838|122|P|doctor may change your diabetes treatment during your pregnancy||
0838|123|P|(such as diet and medications including insulin).||
0838|124|P|   It is unknown if this drug passes into breast milk. Consult||
0838|125|P|your doctor before breastfeeding.||
0838|126|B|||
0838|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0838|128|I|medications work or increase your risk for serious side effects.||
0838|129|I|This document does not contain all possible drug interactions.||
0838|130|I|Keep a list of all the products you use (including||
0838|131|I|prescription/nonprescription drugs and herbal products) and share||
0838|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
0838|133|I|the dosage of any medicines without your doctor's approval.||
0838|134|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0838|135|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0838|136|I|heartbeat you would usually feel when your blood sugar falls too||
0838|137|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0838|138|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0838|139|I|   Many drugs can affect your blood sugar, making it harder to||
0838|140|I|control. Before you start, stop, or change any medication, talk||
0838|141|I|with your doctor or pharmacist about how the medication may||
0838|142|I|affect your blood sugar. Check your blood sugar regularly as||
0838|143|I|directed and share the results with your doctor. Tell your doctor||
0838|144|I|right away if you have symptoms of high or low blood sugar. (See||
0838|145|I|also Side Effects section.) Your doctor may need to adjust your||
0838|146|I|diabetes medication, exercise program, or diet.||
0838|147|B|||
0838|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0838|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0838|150|O|poison control center right away. US residents can call||
0838|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0838|152|B|||
0838|153|N|NOTES:  Do not share this medication with others.||
0838|154|N|   Lab and/or medical tests (such as kidney function, blood||
0838|155|N|glucose, hemoglobin A1c) should be done while you are taking this||
0838|156|N|medication. Keep all medical and lab appointments. Consult your||
0838|157|N|doctor for more details.||
0838|158|N|   Attend a diabetes education program to learn more about how to||
0838|159|N|manage your diabetes with medications, diet, exercise, and||
0838|160|N|regular medical exams.||
0838|161|N|   Learn the symptoms of high and low blood sugar and how to||
0838|162|N|treat low blood sugar. Check your blood sugar regularly as||
0838|163|N|directed.||
0838|164|B|||
0838|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0838|166|D|remember. If it is near the time of the next dose, skip the||
0838|167|D|missed dose. Take your next dose at the regular time. Do not||
0838|168|D|double the dose to catch up.||
0838|169|B|||
0838|170|R|STORAGE:  Store the tablets at room temperature away from light||
0838|171|R|and moisture. Do not store in the bathroom. Some brands of the||
0838|172|R|tablet form of this medication should be stored in their original||
0838|173|R|container and used within 3 months of opening the bottle. Check||
0838|174|R|the product package or ask your pharmacist about your specific||
0838|175|R|brand.||
0838|176|R|   Store the liquid form in the refrigerator away from light. Do||
0838|177|R|not freeze. Once the liquid bottle is opened, this medication||
0838|178|R|expires after 90 days. Keep all medications away from children||
0838|179|R|and pets.||
0838|180|R|   Do not flush medications down the toilet or pour them into a||
0838|181|R|drain unless instructed to do so. Properly discard this product||
0838|182|R|when it is expired or no longer needed. Consult your pharmacist||
0838|183|R|or local waste disposal company.||
0838|184|B|||
0838|185|M|MEDICAL ALERT:  Your condition can cause complications in a||
0838|186|M|medical emergency. For information about enrolling in MedicAlert,||
0838|187|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0838|188|B|||
0838|189|A|Information last revised November 2025.||
0838|190|A|Copyright(c) 2025 First Databank, Inc.||
0838|191|B|||
0839|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0839|002|Z|does NOT have all possible information about this product. This||
0839|003|Z|information does not assure that this product is safe, effective,||
0839|004|Z|or appropriate for you. This information is not individual||
0839|005|Z|medical advice and does not substitute for the advice of your||
0839|006|Z|health care professional. Always ask your health care||
0839|007|Z|professional for complete information about this product and your||
0839|008|Z|specific health needs.||
0839|009|B|||
0839|010|T|FACTOR VIII/VON WILLEBRAND FACTOR, HUMAN - INJECTION||
0839|011|F|(FAK-tor VIII/von-WIL-e-brand FAK-tor)||
0839|012|B|||
0839|013|C|COMMON BRAND NAME(S): Alphanate, Humate-P||
0839|014|B|||
0839|015|U|USES:  This product contains human factor VIII (also called||
0839|016|U|antihemophilic factor) and von Willebrand factor complex. Factors||
0839|017|U|are proteins normally found in the blood that help the blood to||
0839|018|U|thicken (clot) and stop any bleeding. People with low levels of||
0839|019|U|factor VIII and von Willebrand factor are at risk for bleeding||
0839|020|U|longer after an injury/surgery and for bleeding inside the body||
0839|021|U|(especially into the joints and muscles). This product is used to||
0839|022|U|temporarily replace the missing factors and reduce bleeding.||
0839|023|U|   Different brands of this product have different amounts of||
0839|024|U|these factors, and so have different uses. These products are not||
0839|025|U|interchangeable. Do not change brands of this medication without||
0839|026|U|the approval of your doctor. Some products are used to control||
0839|027|U|and prevent bleeding episodes in people with low levels of factor||
0839|028|U|VIII (hemophilia A). Some products are used to control and||
0839|029|U|prevent bleeding episodes in people with low levels of von||
0839|030|U|Willebrand factor (von Willebrand disease). Some products are||
0839|031|U|used to prevent excessive bleeding during and after surgery in||
0839|032|U|patients with von Willebrand disease.||
0839|033|B|||
0839|034|H|HOW TO USE:  This medication is given by slow injection into a||
0839|035|H|vein as directed by your doctor. How fast you receive this||
0839|036|H|medication depends on your dose and how you respond to it. See||
0839|037|H|Side Effects section.||
0839|038|H|   This medication is given in a hemophilia treatment center or||
0839|039|H|hospital. In some cases, patients may be able to give this||
0839|040|H|medication to themselves at home. If your doctor directs you to||
0839|041|H|give this medication at home, read the product information||
0839|042|H|available from your pharmacist before you start using this||
0839|043|H|medication and each time you get a refill. Learn all preparation||
0839|044|H|and usage instructions in the product package. If you have any||
0839|045|H|questions, ask your health care professional.||
0839|046|H|   If the medication and the solution used to mix it were||
0839|047|H|refrigerated, bring both to room temperature before combining.||
0839|048|H|After adding the solution to the powder, gently swirl the vial to||
0839|049|H|completely dissolve the powder. Do not shake the vial. Before||
0839|050|H|using, check this product for particles or discoloration. If||
0839|051|H|either is present, do not use the liquid. After the medication is||
0839|052|H|mixed, use right away.||
0839|053|H|   The dosage is based on your medical condition, weight, blood||
0839|054|H|test results, and response to treatment. Follow your doctor's||
0839|055|H|instructions closely. Ask your doctor or pharmacist if you have||
0839|056|H|any questions.||
0839|057|H|   Learn how to store and discard needles and medical supplies||
0839|058|H|safely. Consult your pharmacist.||
0839|059|H|   Tell your doctor if your condition does not get better or if||
0839|060|H|it gets worse.||
0839|061|B|||
0839|062|S|SIDE EFFECTS:  Flushing of the face, nausea, vomiting, and fast||
0839|063|S|heartbeat may sometimes occur and can be lessened by giving this||
0839|064|S|medication more slowly. Burning/redness/irritation at the||
0839|065|S|injection site, fever, chills, and numbness/tingling of the||
0839|066|S|hands/feet may also occur. If any of these effects last or get||
0839|067|S|worse, tell your doctor or pharmacist promptly.||
0839|068|S|   Remember that this medication has been prescribed because your||
0839|069|S|doctor has judged that the benefit to you is greater than the||
0839|070|S|risk of side effects. Many people using this medication do not||
0839|071|S|have serious side effects.||
0839|072|S|   Tell your doctor right away if you have any serious side||
0839|073|S|effects, including: signs of anemia (such as tiredness, low||
0839|074|S|energy, pale skin color, shortness of breath), new or worsening||
0839|075|S|bleeding/bruising.||
0839|076|S|   This medication may rarely cause serious blood clots. Get||
0839|077|S|medical help right away if you notice any of the following very||
0839|078|S|serious side effects: pain/swelling/warmth in the groin/calf,||
0839|079|S|chest/jaw/left arm pain, sudden vision changes, confusion,||
0839|080|S|trouble speaking, weakness on one side of the body, sudden/severe||
0839|081|S|headaches, sudden dizziness/fainting, shortness of breath/rapid||
0839|082|S|breathing, unusual sweating.||
0839|083|S|   A very serious allergic reaction to this drug is rare.||
0839|084|S|However, get medical help right away if you notice any symptoms||
0839|085|S|of a serious allergic reaction, including: rash, itching/swelling||
0839|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0839|087|S|breathing.||
0839|088|S|   This is not a complete list of possible side effects. If you||
0839|089|S|notice other effects not listed above, contact your doctor or||
0839|090|S|pharmacist.||
0839|091|S|   In the US -||
0839|092|S|   Call your doctor for medical advice about side effects. You||
0839|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0839|094|S|www.fda.gov/medwatch.||
0839|095|S|   In Canada - Call your doctor for medical advice about side||
0839|096|S|effects. You may report side effects to Health Canada at||
0839|097|S|1-866-234-2345.||
0839|098|B|||
0839|099|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0839|100|P|pharmacist if you are allergic to any clotting factor products;||
0839|101|P|or if you have any other allergies. This product may contain||
0839|102|P|inactive ingredients, which can cause allergic reactions or other||
0839|103|P|problems. Talk to your pharmacist for more details.||
0839|104|P|   Before using this medication, tell your doctor or pharmacist||
0839|105|P|your medical history.||
0839|106|P|   Manufacturers of some factor VIII products recommend that you||
0839|107|P|monitor your heartbeat during treatment. If your heart starts to||
0839|108|P|beat faster, it is recommended that you give this medication more||
0839|109|P|slowly or temporarily stop the infusion until your heart rate||
0839|110|P|returns to normal. Consult your doctor for more details.||
0839|111|P|   This medication is made from human blood. Even though the||
0839|112|P|blood is carefully tested, and this medication goes through a||
0839|113|P|special manufacturing process, there is an extremely small chance||
0839|114|P|that you may get infections from the medication (for example,||
0839|115|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
0839|116|P|more information.||
0839|117|P|   During pregnancy, this medication should be used only when||
0839|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
0839|119|P|   It is unknown if this drug passes into breast milk. Consult||
0839|120|P|your doctor before breastfeeding.||
0839|121|B|||
0839|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0839|123|I|medications work or increase your risk for serious side effects.||
0839|124|I|This document does not contain all possible drug interactions.||
0839|125|I|Keep a list of all the products you use (including||
0839|126|I|prescription/nonprescription drugs and herbal products) and share||
0839|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
0839|128|I|the dosage of any medicines without your doctor's approval.||
0839|129|B|||
0839|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0839|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0839|132|O|poison control center right away. US residents can call||
0839|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0839|134|B|||
0839|135|N|NOTES:  Do not share this medication with others.||
0839|136|N|   Lab tests (such as factor VIII levels, von Willebrand factor||
0839|137|N|levels, clotting tests) should be done while you are using this||
0839|138|N|medication. Keep all medical and lab appointments. Consult your||
0839|139|N|doctor for more details.||
0839|140|B|||
0839|141|D|MISSED DOSE:  It is important to follow the dosing schedule as||
0839|142|D|directed by your doctor. If you miss a dose, ask your doctor or||
0839|143|D|pharmacist right away for a new dosing schedule. Do not double||
0839|144|D|the dose to catch up.||
0839|145|B|||
0839|146|R|STORAGE:  Different brands of this medication have different||
0839|147|R|storage needs. Check the product package for instructions on how||
0839|148|R|to store your brand, or ask your pharmacist. Keep all medications||
0839|149|R|away from children and pets.||
0839|150|R|   Do not flush medications down the toilet or pour them into a||
0839|151|R|drain unless instructed to do so. Properly discard this product||
0839|152|R|when it is expired or no longer needed. Consult your pharmacist||
0839|153|R|or local waste disposal company.||
0839|154|B|||
0839|155|M|MEDICAL ALERT:  Your condition can cause complications in a||
0839|156|M|medical emergency. For information about enrolling in MedicAlert,||
0839|157|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0839|158|B|||
0839|159|A|Information last revised November 2024.||
0839|160|A|Copyright(c) 2025 First Databank, Inc.||
0839|161|B|||
0841|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0841|002|Z|does NOT have all possible information about this product. This||
0841|003|Z|information does not assure that this product is safe, effective,||
0841|004|Z|or appropriate for you. This information is not individual||
0841|005|Z|medical advice and does not substitute for the advice of your||
0841|006|Z|health care professional. Always ask your health care||
0841|007|Z|professional for complete information about this product and your||
0841|008|Z|specific health needs.||
0841|009|B|||
0841|010|T|GENTAMICIN DROPS - OPHTHALMIC||
0841|011|F|(jen-ta-MYE-sin)||
0841|012|B|||
0841|013|C|COMMON BRAND NAME(S): Garamycin, Gentak||
0841|014|B|||
0841|015|U|USES:  This medication is used to treat bacterial infections||
0841|016|U|(such as blepharitis, conjunctivitis) of the eye and the skin||
0841|017|U|around the eyes (such as eyelids). It is also used to prevent||
0841|018|U|infection after eye injury or surgery. It belongs to a class of||
0841|019|U|drugs known as aminoglycoside antibiotics. Gentamicin works by||
0841|020|U|killing the bacteria.||
0841|021|U|   This medication treats only bacterial eye infections. It will||
0841|022|U|not work for other types of eye infections. Unnecessary use or||
0841|023|U|misuse of any antibiotic can lead to its decreased effectiveness.||
0841|024|B|||
0841|025|H|HOW TO USE:  Use this medication in the affected eye(s) as||
0841|026|H|directed by your doctor, usually every 4 hours.||
0841|027|H|   To apply eye drops, wash your hands first. To avoid||
0841|028|H|contamination, do not touch the dropper tip or let it touch your||
0841|029|H|eye or any other surface. Use in the eyes only. Do not swallow or||
0841|030|H|inject.||
0841|031|H|   Do not wear contact lenses while you are using this||
0841|032|H|medication. Sterilize contact lenses according to the||
0841|033|H|manufacturer's directions, and check with your doctor before you||
0841|034|H|begin using them again.||
0841|035|H|   Tilt your head back, look upward, and pull down the lower||
0841|036|H|eyelid to make a pouch. Hold the dropper directly over your eye||
0841|037|H|and place one drop into the pouch as directed by your doctor.||
0841|038|H|Look downward, gently close your eyes, and place one finger at||
0841|039|H|the corner of your eye (near the nose). Apply gentle pressure for||
0841|040|H|1 to 2 minutes before opening your eyes. This will prevent the||
0841|041|H|medication from draining out. Try not to blink or rub your eye.||
0841|042|H|Repeat these steps for your other eye if so directed or if your||
0841|043|H|dose is for more than 1 drop. Do not rinse the dropper. Replace||
0841|044|H|the dropper cap after each use.||
0841|045|H|   The dosage is based on your medical condition and response to||
0841|046|H|treatment. Your doctor may direct you to use this medication more||
0841|047|H|often at first, then use it less often as the infection improves.||
0841|048|H|Follow your doctor's directions carefully. Your doctor may||
0841|049|H|prescribe gentamicin drops for use during the day and gentamicin||
0841|050|H|ointment at bedtime.||
0841|051|H|   If you are using another kind of eye medication (such as drops||
0841|052|H|or ointments), wait at least 5 minutes before applying other||
0841|053|H|medications. Use eye drops before eye ointments to allow the||
0841|054|H|drops to enter the eye.||
0841|055|H|   Wait several minutes for your vision to clear before driving||
0841|056|H|or operating machinery.||
0841|057|H|   Use this medication regularly in order to get the most benefit||
0841|058|H|from it. To help you remember, use it at the same times each day.||
0841|059|H|Continue to use this medication for the full time prescribed,||
0841|060|H|even if symptoms disappear after a few days. Stopping the||
0841|061|H|medication too early may result in a return of the infection.||
0841|062|H|   Tell your doctor if your condition lasts or gets worse.||
0841|063|B|||
0841|064|S|SIDE EFFECTS:  Eye stinging/burning/redness or temporary blurred||
0841|065|S|vision may occur. If any of these effects last or get worse, tell||
0841|066|S|your doctor or pharmacist promptly.||
0841|067|S|   Remember that this medication has been prescribed because your||
0841|068|S|doctor has judged that the benefit to you is greater than the||
0841|069|S|risk of side effects. Many people using this medication do not||
0841|070|S|have serious side effects.||
0841|071|S|   Use of this medication for prolonged or repeated periods may||
0841|072|S|result in other types of eye infections, including fungal||
0841|073|S|infections. Stop using this medication and contact your doctor if||
0841|074|S|you notice new or worsening eye symptoms (such as pain, swelling,||
0841|075|S|thick discharge or pus).||
0841|076|S|   Rarely, gentamicin products used in the eye may be absorbed||
0841|077|S|and may cause serious side effects. Tell your doctor right away||
0841|078|S|if you have any serious side effects, including: easy||
0841|079|S|bruising/bleeding, mental/mood changes (such as hallucinations).||
0841|080|S|   A very serious allergic reaction to this drug is rare.||
0841|081|S|However, get medical help right away if you notice any symptoms||
0841|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0841|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0841|084|S|breathing.||
0841|085|S|   This is not a complete list of possible side effects. If you||
0841|086|S|notice other effects not listed above, contact your doctor or||
0841|087|S|pharmacist.||
0841|088|S|   In the US -||
0841|089|S|   Call your doctor for medical advice about side effects. You||
0841|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0841|091|S|www.fda.gov/medwatch.||
0841|092|S|   In Canada - Call your doctor for medical advice about side||
0841|093|S|effects. You may report side effects to Health Canada at||
0841|094|S|1-866-234-2345.||
0841|095|B|||
0841|096|P|PRECAUTIONS:  Before using gentamicin, tell your doctor or||
0841|097|P|pharmacist if you are allergic to it; or to other aminoglycoside||
0841|098|P|antibiotics (such as tobramycin); or if you have any other||
0841|099|P|allergies. This product may contain inactive ingredients, which||
0841|100|P|can cause allergic reactions or other problems. Talk to your||
0841|101|P|pharmacist for more details.||
0841|102|P|   Before using this medication, tell your doctor or pharmacist||
0841|103|P|your medical history.||
0841|104|P|   After you apply this drug, your vision may become temporarily||
0841|105|P|blurred. Do not drive, use machinery, or do anything that needs||
0841|106|P|clear vision until you can do it safely.||
0841|107|P|   Before having surgery, tell your doctor or dentist about all||
0841|108|P|the products you use (including prescription drugs,||
0841|109|P|nonprescription drugs, and herbal products).||
0841|110|P|   During pregnancy, this medication should be used only when||
0841|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
0841|112|P|   This drug may pass into breast milk. Consult your doctor||
0841|113|P|before breastfeeding.||
0841|114|B|||
0841|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0841|116|I|medications work or increase your risk for serious side effects.||
0841|117|I|This document does not contain all possible drug interactions.||
0841|118|I|Keep a list of all the products you use (including||
0841|119|I|prescription/nonprescription drugs and herbal products) and share||
0841|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
0841|121|I|the dosage of any medicines without your doctor's approval.||
0841|122|B|||
0841|123|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0841|124|O|has overdosed and has serious symptoms such as passing out or||
0841|125|O|trouble breathing, call 911. Otherwise, call a poison control||
0841|126|O|center right away. US residents can call 1-800-222-1222. Canada||
0841|127|O|residents can call 1-844-764-7669.||
0841|128|B|||
0841|129|N|NOTES:  Do not share this medication with others.||
0841|130|N|   This medication has been prescribed for your current condition||
0841|131|N|only. Do not use it later for another infection unless your||
0841|132|N|doctor tells you to.||
0841|133|B|||
0841|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0841|135|D|If it is near the time of the next dose, skip the missed dose.||
0841|136|D|Use your next dose at the regular time. Do not double the dose to||
0841|137|D|catch up.||
0841|138|B|||
0841|139|R|STORAGE:  Different brands of this medication have different||
0841|140|R|storage needs. Check the product package for instructions on how||
0841|141|R|to store your brand, or ask your pharmacist. Do not freeze. Keep||
0841|142|R|all medications away from children and pets.||
0841|143|R|   Do not flush medications down the toilet or pour them into a||
0841|144|R|drain unless instructed to do so. Properly discard this product||
0841|145|R|when it is expired or no longer needed. Consult your pharmacist||
0841|146|R|or local waste disposal company.||
0841|147|B|||
0841|148|A|Information last revised May 2024.||
0841|149|A|Copyright(c) 2025 First Databank, Inc.||
0841|150|B|||
0844|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0844|002|Z|does NOT have all possible information about this product. This||
0844|003|Z|information does not assure that this product is safe, effective,||
0844|004|Z|or appropriate for you. This information is not individual||
0844|005|Z|medical advice and does not substitute for the advice of your||
0844|006|Z|health care professional. Always ask your health care||
0844|007|Z|professional for complete information about this product and your||
0844|008|Z|specific health needs.||
0844|009|B|||
0844|010|T|FRAMYCETIN/HYDROCORTISONE/DIBUCAINE/ESCULIN OINTMENT - RECTAL||
0844|011|F|(fram-eye-SEAT-in/hi-dro-KORT-ih-sown/DYE-byoo-kane/ES-kyu-lin)||
0844|012|B|||
0844|013|U|USES:  This combination medication is used to treat pain,||
0844|014|U|itching, swelling, and discomfort caused by hemorrhoids and other||
0844|015|U|problems of the anal area (such as anal fissures). It may also be||
0844|016|U|used before and after anal surgery (such as hemorrhoid removal||
0844|017|U|and anal fissure repair).||
0844|018|U|   This combination product contains dibucaine (also known as||
0844|019|U|cinchocaine), an anesthetic that works by temporarily numbing the||
0844|020|U|area, and hydrocortisone, a corticosteroid that reduces redness,||
0844|021|U|itching, and swelling. It also contains an aminoglycoside||
0844|022|U|antibiotic called framycetin (also known as neomycin B) that||
0844|023|U|works by stopping the growth of bacteria. Framycetin works only||
0844|024|U|on bacterial infections. It will not work for other types of||
0844|025|U|infections (such as infections caused by fungi, viruses).||
0844|026|U|Unnecessary use or misuse of any antibiotic can lead to its||
0844|027|U|decreased effectiveness.||
0844|028|U|   This product also contains esculin, a natural substance found||
0844|029|U|in horse chestnut. Esculin is similar to hydroxycoumarin, which||
0844|030|U|is a "blood thinner" (anticoagulant). It has been used to||
0844|031|U|decrease swelling. It may increase the risk of bleeding and may||
0844|032|U|be harmful if swallowed.||
0844|033|B|||
0844|034|H|HOW TO USE:  Follow all instructions in the product package for||
0844|035|H|using the applicator tip/cap/nozzle. Before use, clean the||
0844|036|H|affected area with mild soap and water, rinse well, and pat dry.||
0844|037|H|If applying inside the anus, gently insert the applicator tip||
0844|038|H|inside the anus and apply the product in and around the anal||
0844|039|H|opening as directed in the package instructions or by your||
0844|040|H|doctor. Do not insert any part of the container into the anus.||
0844|041|H|   To apply the product to the outside of the anus only, apply a||
0844|042|H|small amount to the affected area and rub in gently.||
0844|043|H|   Do not cover the area with plastic or waterproof bandages||
0844|044|H|unless directed to do so by your doctor. Covering the treated||
0844|045|H|area may increase the absorption of the medication through the||
0844|046|H|skin. This may improve how well the drug works, but it may also||
0844|047|H|increase the risk of side effects.||
0844|048|H|   Wash hands immediately after use. Avoid getting the product in||
0844|049|H|your eyes, nose, ears or mouth. If the medication gets in these||
0844|050|H|areas, rinse the area immediately with clean water.||
0844|051|H|   Use this product as directed by your doctor, usually twice||
0844|052|H|daily and after each bowel movement. The dosage is based on your||
0844|053|H|medical condition and response to treatment. Use this medication||
0844|054|H|regularly in order to get the most benefit from it. To help you||
0844|055|H|remember, use it at the same times each day.||
0844|056|H|   Do not use more of this product, use it more often, or keep||
0844|057|H|using it longer than prescribed by your doctor. If you have been||
0844|058|H|using this medication for a long time or in high doses, do not||
0844|059|H|suddenly stop using it without your doctor's approval. Some||
0844|060|H|conditions may become worse when this drug is suddenly stopped.||
0844|061|H|Your dose may need to be gradually decreased.||
0844|062|H|   Tell your doctor if your condition does not get better or if||
0844|063|H|it gets worse.||
0844|064|B|||
0844|065|S|SIDE EFFECTS:  Redness, burning, or itching at the application||
0844|066|S|site may occur. If any of these effects last or get worse, tell||
0844|067|S|your doctor or pharmacist promptly.||
0844|068|S|   Remember that this medication has been prescribed because your||
0844|069|S|doctor has judged that the benefit to you is greater than the||
0844|070|S|risk of side effects. Many people using this medication do not||
0844|071|S|have serious side effects.||
0844|072|S|   Tell your doctor right away if you have any serious side||
0844|073|S|effects, including: rectal bleeding, change in skin appearance||
0844|074|S|(such as color, thickness), skin redness/tenderness/pus, easy||
0844|075|S|bleeding/bruising, hearing problems (such as ringing in the||
0844|076|S|ears), slow/irregular heartbeat, signs of infection (such as sore||
0844|077|S|throat that doesn't go away, fever, chills).||
0844|078|S|   Rarely, it is possible this medication will be absorbed into||
0844|079|S|the bloodstream. This can lead to side effects of too much||
0844|080|S|corticosteroid. These side effects are more likely in children||
0844|081|S|and people who use this medication for a long time. Tell your||
0844|082|S|doctor right away if any of the following side effects occur:||
0844|083|S|unusual/extreme tiredness, weight loss, headache, swelling||
0844|084|S|ankles/feet, increased thirst/urination, vision problems.||
0844|085|S|   A very serious allergic reaction to this drug is rare.||
0844|086|S|However, get medical help right away if you notice any symptoms||
0844|087|S|of a serious allergic reaction, including: rash, itching/swelling||
0844|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0844|089|S|breathing.||
0844|090|S|   This is not a complete list of possible side effects. If you||
0844|091|S|notice other effects not listed above, contact your doctor or||
0844|092|S|pharmacist.||
0844|093|S|   In the US -||
0844|094|S|   Call your doctor for medical advice about side effects. You||
0844|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0844|096|S|www.fda.gov/medwatch.||
0844|097|S|   In Canada - Call your doctor for medical advice about side||
0844|098|S|effects. You may report side effects to Health Canada at||
0844|099|S|1-866-234-2345.||
0844|100|B|||
0844|101|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0844|102|P|pharmacist if you are allergic to dibucaine or other amide||
0844|103|P|anesthetics (such as bupivacaine, prilocaine), hydrocortisone or||
0844|104|P|other corticosteroids (such as prednisone), or framycetin or||
0844|105|P|other aminoglycoside antibiotics (such as neomycin); or to any||
0844|106|P|other ingredient in this product (such as esculin, lanolin); or||
0844|107|P|if you have any other allergies. This product may contain||
0844|108|P|inactive ingredients (such as latex), which can cause allergic||
0844|109|P|reactions or other problems. Talk to your pharmacist for more||
0844|110|P|details.||
0844|111|P|   Before using this medication, tell your doctor or pharmacist||
0844|112|P|your medical history, especially of: infections (especially||
0844|113|P|fungal/viral infections, tuberculosis, rectal sores/infections),||
0844|114|P|diabetes, eye problems (such as glaucoma), liver disease,||
0844|115|P|stomach/intestinal problems.||
0844|116|P|   Rarely, using corticosteroid medications for a long time can||
0844|117|P|make it more difficult for your body to respond to physical||
0844|118|P|stress. Before having surgery or emergency treatment, or if you||
0844|119|P|get a serious illness/injury, tell your doctor or dentist that||
0844|120|P|you are using this medication or have used this medication within||
0844|121|P|the past few months.||
0844|122|P|   Though it is unlikely, this medication may temporarily slow||
0844|123|P|down a child's growth if used for a long time. See the doctor||
0844|124|P|regularly so your child's height can be checked.||
0844|125|P|   During pregnancy, this medication should be used only when||
0844|126|P|clearly needed. It should not be used for long time or in large||
0844|127|P|amounts. Discuss the risks and benefits with your doctor.||
0844|128|P|   It is unknown if this medication passes into breast milk.||
0844|129|P|Consult your doctor before breastfeeding.||
0844|130|B|||
0844|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0844|132|I|medications work or increase your risk for serious side effects.||
0844|133|I|This document does not contain all possible drug interactions.||
0844|134|I|Keep a list of all the products you use (including||
0844|135|I|prescription/nonprescription drugs and herbal products) and share||
0844|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
0844|137|I|the dosage of any medicines without your doctor's approval.||
0844|138|I|   Some products that may interact with this drug are:||
0844|139|I|antiplatelet medication (such as clopidogrel), "blood thinners"||
0844|140|I|(such as warfarin), desmopressin.||
0844|141|B|||
0844|142|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0844|143|O|has overdosed and has serious symptoms such as passing out or||
0844|144|O|trouble breathing, call 911. Otherwise, call a poison control||
0844|145|O|center right away. US residents can call 1-800-222-1222. Canada||
0844|146|O|residents can call 1-844-764-7669.||
0844|147|B|||
0844|148|N|NOTES:  Lab and/or medical tests (such as cortisol levels) may be||
0844|149|N|done while you are using this medication. Keep all medical and||
0844|150|N|lab appointments. Consult your doctor for more details.||
0844|151|N|   This medication has been prescribed for your current condition||
0844|152|N|only. Do not use it later for another condition unless told to do||
0844|153|N|so by your doctor. A different medication may be necessary in||
0844|154|N|that case.||
0844|155|B|||
0844|156|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
0844|157|D|unless it is almost time for the next dose. In that case, skip||
0844|158|D|the missed dose. Use your next dose at the regular time. Do not||
0844|159|D|apply more of the medication or use more often to catch up.||
0844|160|B|||
0844|161|R|STORAGE:  Store at room temperature. Do not refrigerate. Keep all||
0844|162|R|medications away from children and pets.||
0844|163|R|   Do not flush medications down the toilet or pour them into a||
0844|164|R|drain unless instructed to do so. Properly discard this product||
0844|165|R|when it is expired or no longer needed. Consult your pharmacist||
0844|166|R|or local waste disposal company.||
0844|167|B|||
0844|168|A|Information last revised April 2025.||
0844|169|A|Copyright(c) 2025 First Databank, Inc.||
0844|170|B|||
0845|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0845|002|Z|does NOT have all possible information about this product. This||
0845|003|Z|information does not assure that this product is safe, effective,||
0845|004|Z|or appropriate for you. This information is not individual||
0845|005|Z|medical advice and does not substitute for the advice of your||
0845|006|Z|health care professional. Always ask your health care||
0845|007|Z|professional for complete information about this product and your||
0845|008|Z|specific health needs.||
0845|009|B|||
0845|010|T|BELLADONNA ALKALOIDS/PHENOBARBITAL - ORAL||
0845|011|F|(bell-a-DON-a al-KA-loyd/FEE-noe-BAR-bi-tal)||
0845|012|B|||
0845|013|U|USES:  This product contains several medications: belladonna||
0845|014|U|alkaloids (made up of the drugs hyoscyamine, atropine, and||
0845|015|U|scopolamine) and phenobarbital. Belladonna alkaloids help to||
0845|016|U|reduce the symptoms of stomach and intestinal cramping. They work||
0845|017|U|by slowing the natural movements of the gut and by relaxing the||
0845|018|U|muscles in the stomach and intestines. Belladonna alkaloids||
0845|019|U|belong to a class of drugs known as||
0845|020|U|anticholinergics/antispasmodics. Phenobarbital helps to reduce||
0845|021|U|anxiety. It acts on the brain to produce a calming effect.||
0845|022|U|Phenobarbital belongs to a class of drugs known as barbiturate||
0845|023|U|sedatives.||
0845|024|B|||
0845|025|V|OTHER USES:  This section contains uses of this drug that are not||
0845|026|V|listed in the approved professional labeling for the drug but||
0845|027|V|that may be prescribed by your health care professional. Use this||
0845|028|V|drug for a condition that is listed in this section only if it||
0845|029|V|has been so prescribed by your health care professional.||
0845|030|V|   This drug may also be used to relieve the symptoms of||
0845|031|V|irritable bowel syndrome.||
0845|032|B|||
0845|033|H|HOW TO USE:  Take this medication by mouth as directed by your||
0845|034|H|doctor. If you are taking the immediate-release tablets or liquid||
0845|035|H|form of this medication, take it as directed by your doctor,||
0845|036|H|usually 3 to 4 times a day.||
0845|037|H|   If you are using the liquid, carefully measure the dose using||
0845|038|H|a special measuring device/spoon. Do not use a household spoon||
0845|039|H|because you may not get the correct dose.||
0845|040|H|   If you are taking the extended-release tablets, take them as||
0845|041|H|directed by your doctor, usually every 12 hours. Do not crush or||
0845|042|H|chew extended-release tablets. Doing so can release all of the||
0845|043|H|drug at once, increasing the risk of side effects. Swallow the||
0845|044|H|whole tablet without crushing or chewing.||
0845|045|H|   Antacids lower the absorption of this medication. If you are||
0845|046|H|taking an antacid, take it at least 2 hours apart from this||
0845|047|H|medication.||
0845|048|H|   The dosage is based on your medical condition and response to||
0845|049|H|treatment. Children's dosage is also based on weight.||
0845|050|H|   Do not increase your dose or take this drug more often without||
0845|051|H|your doctor's approval. Your condition will not improve any||
0845|052|H|faster and the risk of serious side effects may increase.||
0845|053|H|   If you suddenly stop using this medication, you may have||
0845|054|H|withdrawal symptoms (such as anxiety, muscle twitching,||
0845|055|H|shakiness, dizziness, worsening weakness, nausea, vomiting).||
0845|056|H|Withdrawal from the phenobarbital can be severe and include||
0845|057|H|seizures and (rarely) death. To help prevent withdrawal, your||
0845|058|H|doctor may lower your dose slowly. Withdrawal is more likely if||
0845|059|H|you have used this medication for a long time or in high doses.||
0845|060|H|Tell your doctor or pharmacist right away if you have withdrawal.||
0845|061|H|   When this medication is used for a long time, it may not work||
0845|062|H|as well. Your doctor may need to increase your dose or change||
0845|063|H|your medication. Talk with your doctor if this medication stops||
0845|064|H|working well.||
0845|065|H|   Though it helps many people, this medication may sometimes||
0845|066|H|cause addiction. This risk may be higher if you have a substance||
0845|067|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0845|068|H|Take this medication exactly as prescribed to lower the risk of||
0845|069|H|addiction. Ask your doctor or pharmacist for more details.||
0845|070|H|   Tell your doctor if your condition lasts or gets worse.||
0845|071|B|||
0845|072|S|SIDE EFFECTS:  Dizziness, drowsiness, weakness, blurred vision,||
0845|073|S|dry eyes, dry mouth, nausea, constipation, and abdominal bloating||
0845|074|S|may occur. If any of these effects last or get worse, tell your||
0845|075|S|doctor or pharmacist promptly.||
0845|076|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0845|077|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0845|078|S|substitute. To relieve dry eyes, consult your pharmacist for||
0845|079|S|artificial tears or other eye lubricants.||
0845|080|S|   To prevent constipation, eat dietary fiber, drink enough||
0845|081|S|water, and exercise. You may also need to take a laxative. Ask||
0845|082|S|your pharmacist which type of laxative is right for you.||
0845|083|S|   Remember that this medication has been prescribed because your||
0845|084|S|doctor has judged that the benefit to you is greater than the||
0845|085|S|risk of side effects. Many people using this medication do not||
0845|086|S|have serious side effects.||
0845|087|S|   Tell your doctor right away if you have any serious side||
0845|088|S|effects, including: decreased sweating, dry/hot/flushed skin,||
0845|089|S|fast/irregular heartbeat, loss of coordination, trouble speaking,||
0845|090|S|fainting, mental/mood changes (such as confusion, agitation,||
0845|091|S|unusual excitement, depression, rare thoughts of suicide),||
0845|092|S|difficulty urinating, decreased sexual ability, signs of anemia||
0845|093|S|(such as unusual tiredness, pale skin), easy bruising/bleeding.||
0845|094|S|   Get medical help right away if you have any very serious side||
0845|095|S|effects, including: eye pain/swelling/redness, vision changes||
0845|096|S|(such as seeing rainbows around lights at night), slow/shallow||
0845|097|S|breathing.||
0845|098|S|   A very serious allergic reaction to this drug is rare.||
0845|099|S|However, get medical help right away if you notice any symptoms||
0845|100|S|of a serious allergic reaction, including: fever, swollen lymph||
0845|101|S|nodes, rash, itching/swelling (especially of the||
0845|102|S|face/tongue/throat), severe dizziness, trouble breathing.||
0845|103|S|   This is not a complete list of possible side effects. If you||
0845|104|S|notice other effects not listed above, contact your doctor or||
0845|105|S|pharmacist.||
0845|106|S|   In the US -||
0845|107|S|   Call your doctor for medical advice about side effects. You||
0845|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0845|109|S|www.fda.gov/medwatch.||
0845|110|S|   In Canada - Call your doctor for medical advice about side||
0845|111|S|effects. You may report side effects to Health Canada at||
0845|112|S|1-866-234-2345.||
0845|113|B|||
0845|114|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0845|115|P|pharmacist if you are allergic to hyoscyamine, atropine, or||
0845|116|P|scopolamine; or to anti-seizure medications (such as||
0845|117|P|carbamazepine, fosphenytoin, oxcarbazepine, phenytoin,||
0845|118|P|primidone); or if you have any other allergies. This product may||
0845|119|P|contain inactive ingredients, which can cause allergic reactions||
0845|120|P|or other problems. Talk to your pharmacist for more details.||
0845|121|P|   Before using this medication, tell your doctor or pharmacist||
0845|122|P|your medical history, especially of: personal or family history||
0845|123|P|of glaucoma (angle-closure type), problems with urination (due to||
0845|124|P|enlarged prostate, a blocked urinary tract), other||
0845|125|P|stomach/intestinal problems (such as slow gut, blockage,||
0845|126|P|ulcerative colitis, infection, little/no stomach acid,||
0845|127|P|ileostomy/colostomy patients with diarrhea), overactive thyroid,||
0845|128|P|heart problems (such as coronary artery disease, angina, heart||
0845|129|P|failure, fast/irregular heartbeat, heart problems due to severe||
0845|130|P|bleeding), high blood pressure, heartburn problems (such as acid||
0845|131|P|reflux, hiatal hernia, esophagus problems), certain nervous||
0845|132|P|system problem (autonomic neuropathy), myasthenia gravis, liver||
0845|133|P|problems, kidney problems, a certain blood disorder (porphyria),||
0845|134|P|restlessness or excitement during past use of phenobarbital,||
0845|135|P|breathing/lung problems, personal or family history of a||
0845|136|P|substance use disorder (such as overuse of or addiction to||
0845|137|P|drugs/alcohol), mental/mood conditions (such as depression,||
0845|138|P|thoughts of suicide, psychosis).||
0845|139|P|   This drug may make you dizzy or drowsy or blur your vision.||
0845|140|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0845|141|P|drowsy. Do not drive, use machinery, or do anything that needs||
0845|142|P|alertness or clear vision until you can do it safely. Avoid||
0845|143|P|alcoholic beverages. Talk to your doctor if you are using||
0845|144|P|marijuana (cannabis).||
0845|145|P|   The liquid form of this product may contain alcohol or sugar.||
0845|146|P|Caution is advised if you have diabetes, alcohol dependence,||
0845|147|P|liver disease, or any other condition that requires you to||
0845|148|P|limit/avoid these substances in your diet. Ask your doctor or||
0845|149|P|pharmacist about using this product safely.||
0845|150|P|   This medication may make you sweat less, making you more||
0845|151|P|likely to get heat stroke. Avoid doing things that may cause you||
0845|152|P|to overheat, such as hard work or exercise in hot weather, or||
0845|153|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0845|154|P|and dress lightly. If you overheat, quickly look for a place to||
0845|155|P|cool down and rest. Get medical help right away if you have a||
0845|156|P|fever that does not go away, mental/mood changes, headache, or||
0845|157|P|dizziness.||
0845|158|P|   Older adults may be more sensitive to the side effects of this||
0845|159|P|drug, especially drowsiness, confusion, unusual excitement,||
0845|160|P|constipation, and urination problems. Drowsiness and confusion||
0845|161|P|can increase the risk of falling.||
0845|162|P|   Children may be more sensitive to the side effects of this||
0845|163|P|drug. This drug can often cause excitement instead of drowsiness||
0845|164|P|in young children.||
0845|165|P|   Tell your doctor if you are pregnant or plan to become||
0845|166|P|pregnant. You should not become pregnant while using belladonna||
0845|167|P|alkaloids/phenobarbital. This medication may harm an unborn baby.||
0845|168|P|Ask about reliable forms of non-hormonal birth control (such as||
0845|169|P|condoms, diaphragm with spermicide) while using this medication.||
0845|170|P|If you become pregnant, talk to your doctor right away about the||
0845|171|P|risks and benefits of this medication.||
0845|172|P|   This medication passes into breast milk and may have||
0845|173|P|undesirable effects on a nursing infant. Consult your doctor||
0845|174|P|before breastfeeding.||
0845|175|B|||
0845|176|I|DRUG INTERACTIONS:  See also the How to Use section.||
0845|177|I|   Drug interactions may change how your medications work or||
0845|178|I|increase your risk for serious side effects. This document does||
0845|179|I|not contain all possible drug interactions. Keep a list of all||
0845|180|I|the products you use (including prescription/nonprescription||
0845|181|I|drugs and herbal products) and share it with your doctor and||
0845|182|I|pharmacist. Do not start, stop, or change the dosage of any||
0845|183|I|medicines without your doctor's approval.||
0845|184|I|   Some products that may interact with this drug include:||
0845|185|I|darunavir, potassium tablets/capsules, sodium oxybate, drugs that||
0845|186|I|are affected by slowed gut movement (such as pramlintide).||
0845|187|I|   This medication may affect the absorption of other products||
0845|188|I|such as griseofulvin, certain azole anti-fungal drugs||
0845|189|I|(ketoconazole, itraconazole), slowly dissolving forms of digoxin,||
0845|190|I|among others.||
0845|191|I|   Other medications can affect the removal of phenobarbital from||
0845|192|I|your body, which may affect how this product works. Examples||
0845|193|I|include St. John's wort, among others.||
0845|194|I|   Phenobarbital can speed up the removal of other medications||
0845|195|I|from your body, which may affect how they work. Examples of||
0845|196|I|affected drugs include artemether/lumefantrine, atazanavir,||
0845|197|I|cobicistat, etravirine, lurasidone, ranolazine, rilpivirine,||
0845|198|I|sofosbuvir, sorafenib, voriconazole, certain calcium channel||
0845|199|I|blockers (such as felodipine/nimodipine), among others.||
0845|200|I|   This medication may decrease the effectiveness of hormonal||
0845|201|I|birth control such as pills, patch, or ring. This could cause||
0845|202|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0845|203|I|use reliable backup birth control methods while using this||
0845|204|I|medication. Also tell your doctor if you have any new spotting or||
0845|205|I|breakthrough bleeding, because these may be signs that your birth||
0845|206|I|control is not working well.||
0845|207|I|   The risk of serious side effects (such as slow/shallow||
0845|208|I|breathing, severe drowsiness/dizziness) may be increased if this||
0845|209|I|medication is taken with other products that may also cause||
0845|210|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0845|211|I|if you are taking other products such as opioid pain or cough||
0845|212|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0845|213|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
0845|214|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0845|215|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0845|216|I|diphenhydramine).||
0845|217|I|   Check the labels on all your medicines (such as allergy or||
0845|218|I|cough-and-cold products, diet aids) because they may contain||
0845|219|I|ingredients that cause drowsiness or a fast heartbeat. Ask your||
0845|220|I|pharmacist about using those products safely.||
0845|221|I|   Phenobarbital is very similar to primidone. Do not use||
0845|222|I|medications containing primidone while using phenobarbital.||
0845|223|I|   This medication may interfere with certain lab tests (such as||
0845|224|I|gastric secretion tests), possibly causing false test results.||
0845|225|I|Make sure lab personnel and all your doctors know you use this||
0845|226|I|drug.||
0845|227|B|||
0845|228|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0845|229|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0845|230|O|poison control center right away. US residents can call||
0845|231|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0845|232|O|Symptoms of overdose may include: large pupils, hot/dry skin,||
0845|233|O|fever, severe dizziness, severe drowsiness, severe thirst,||
0845|234|O|mental/mood changes (such as confusion, unusual excitement),||
0845|235|O|fast/irregular heartbeat, muscle weakness, inability to move||
0845|236|O|(paralysis), slowed breathing, fainting, inability to wake up,||
0845|237|O|seizures.||
0845|238|B|||
0845|239|N|NOTES:  Do not share this medication with others.||
0845|240|N|   Management of digestive disorders may include lifestyle||
0845|241|N|changes such as stress reduction programs, exercise, stopping||
0845|242|N|smoking, and dietary changes, in addition to medication. Talk to||
0845|243|N|your doctor or pharmacist about lifestyle changes that might||
0845|244|N|benefit you.||
0845|245|N|   If this medication is used for a long time, lab and/or medical||
0845|246|N|tests (such as blood counts, liver function) may be done while||
0845|247|N|you are taking this medication. Keep all medical and lab||
0845|248|N|appointments. Consult your doctor for more details.||
0845|249|B|||
0845|250|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0845|251|D|remember. If it is near the time of the next dose, skip the||
0845|252|D|missed dose. Take your next dose at the regular time. Do not||
0845|253|D|double the dose to catch up.||
0845|254|B|||
0845|255|R|STORAGE:  Store at room temperature away from light and moisture.||
0845|256|R|Avoid freezing the liquid. Do not store in the bathroom. Keep all||
0845|257|R|medications away from children and pets.||
0845|258|R|   Do not flush medications down the toilet or pour them into a||
0845|259|R|drain unless instructed to do so. Properly discard this product||
0845|260|R|when it is expired or no longer needed. Consult your pharmacist||
0845|261|R|or local waste disposal company.||
0845|262|B|||
0845|263|A|Information last revised March 2025.||
0845|264|A|Copyright(c) 2025 First Databank, Inc.||
0845|265|B|||
0846|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0846|002|Z|does NOT have all possible information about this product. This||
0846|003|Z|information does not assure that this product is safe, effective,||
0846|004|Z|or appropriate for you. This information is not individual||
0846|005|Z|medical advice and does not substitute for the advice of your||
0846|006|Z|health care professional. Always ask your health care||
0846|007|Z|professional for complete information about this product and your||
0846|008|Z|specific health needs.||
0846|009|B|||
0846|010|T|FRAMYCETIN/HYDROCORTISONE/DIBUCAINE/ESCULIN SUPPOSITORY - RECTAL||
0846|011|F|(fram-eye-SEAT-in/hi-dro-KORT-ih-sown/DYE-byoo-kane/ES-kyu-lin)||
0846|012|B|||
0846|013|U|USES:  This combination medication is used to treat pain,||
0846|014|U|itching, swelling, and discomfort caused by hemorrhoids and other||
0846|015|U|problems of the anal area (such as anal fissures, itching). It||
0846|016|U|may also be used before and after anal surgery (such as||
0846|017|U|hemorrhoid removal and anal fissure repair).||
0846|018|U|   This combination product contains dibucaine (also known as||
0846|019|U|cinchocaine), an anesthetic that works by temporarily numbing the||
0846|020|U|area, and hydrocortisone, a corticosteroid that reduces redness,||
0846|021|U|itching, and swelling. It also contains an aminoglycoside||
0846|022|U|antibiotic called framycetin (also known as neomycin B) that||
0846|023|U|works by stopping the growth of bacteria. Framycetin works only||
0846|024|U|on bacterial infections. It will not work for other types of||
0846|025|U|infections (such as infections caused by fungi, viruses).||
0846|026|U|Unnecessary use or misuse of any antibiotic can lead to its||
0846|027|U|decreased effectiveness.||
0846|028|U|   This product also contains esculin, a natural substance found||
0846|029|U|in horse chestnut. Esculin is similar to hydroxycoumarin, which||
0846|030|U|is a "blood thinner" (anticoagulant). It has been used to||
0846|031|U|decrease swelling. It may increase the risk of bleeding and may||
0846|032|U|be harmful if swallowed.||
0846|033|B|||
0846|034|H|HOW TO USE:  Use this product in the rectum only.||
0846|035|H|   Unwrap the suppository and moisten it with a few drops of||
0846|036|H|water. Lie down on your left side with your right knee bent.||
0846|037|H|Gently push one suppository into the rectum with your finger.||
0846|038|H|Remain lying down for a few minutes, and avoid having a bowel||
0846|039|H|movement for at least 1 hour so the drug will be absorbed.||
0846|040|H|   Use this product as directed by your doctor, usually twice||
0846|041|H|daily and after each bowel movement. The dosage is based on your||
0846|042|H|medical condition and response to treatment. Use this medication||
0846|043|H|regularly in order to get the most benefit from it. To help you||
0846|044|H|remember, use it at the same times each day.||
0846|045|H|   Do not use more of this product, use it more often, or keep||
0846|046|H|using it longer than prescribed by your doctor. If you have been||
0846|047|H|using this medication for a long time or in high doses, do not||
0846|048|H|suddenly stop using it without your doctor's approval. Some||
0846|049|H|conditions may become worse when this drug is suddenly stopped.||
0846|050|H|Your dose may need to be gradually decreased.||
0846|051|H|   Wash hands immediately after use. Avoid getting the product in||
0846|052|H|your eyes, nose, ears or mouth. If the medication gets in these||
0846|053|H|areas, rinse the area immediately with clean water.||
0846|054|H|   Tell your doctor if your condition does not get better or if||
0846|055|H|it gets worse.||
0846|056|B|||
0846|057|S|SIDE EFFECTS:  Redness, burning, or itching may occur. If any of||
0846|058|S|these effects last or get worse, tell your doctor or pharmacist||
0846|059|S|promptly.||
0846|060|S|   Remember that this medication has been prescribed because your||
0846|061|S|doctor has judged that the benefit to you is greater than the||
0846|062|S|risk of side effects. Many people using this medication do not||
0846|063|S|have serious side effects.||
0846|064|S|   Tell your doctor right away if you have any serious side||
0846|065|S|effects, including: rectal bleeding, change in skin appearance||
0846|066|S|(such as color, thickness), skin redness/tenderness/pus, easy||
0846|067|S|bleeding/bruising, hearing problems (such as ringing in the||
0846|068|S|ears), slow/irregular heartbeat, signs of infection (such as sore||
0846|069|S|throat that doesn't go away, fever, chills).||
0846|070|S|   Rarely, it is possible this medication will be absorbed into||
0846|071|S|the bloodstream. This can lead to side effects of too much||
0846|072|S|corticosteroid. These side effects are more likely in children||
0846|073|S|and people who use this medication for a long time. Tell your||
0846|074|S|doctor right away if any of the following side effects occur:||
0846|075|S|unusual/extreme tiredness, weight loss, headache, swelling||
0846|076|S|ankles/feet, increased thirst/urination, vision problems.||
0846|077|S|   A very serious allergic reaction to this drug is rare.||
0846|078|S|However, get medical help right away if you notice any symptoms||
0846|079|S|of a serious allergic reaction, including: rash, itching/swelling||
0846|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0846|081|S|breathing.||
0846|082|S|   This is not a complete list of possible side effects. If you||
0846|083|S|notice other effects not listed above, contact your doctor or||
0846|084|S|pharmacist.||
0846|085|S|   In the US -||
0846|086|S|   Call your doctor for medical advice about side effects. You||
0846|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0846|088|S|www.fda.gov/medwatch.||
0846|089|S|   In Canada - Call your doctor for medical advice about side||
0846|090|S|effects. You may report side effects to Health Canada at||
0846|091|S|1-866-234-2345.||
0846|092|B|||
0846|093|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0846|094|P|pharmacist if you are allergic to dibucaine or other amide||
0846|095|P|anesthetics (such as bupivacaine, prilocaine), hydrocortisone or||
0846|096|P|other corticosteroids (such as prednisone), or framycetin or||
0846|097|P|other aminoglycoside antibiotics (such as neomycin); or to any||
0846|098|P|other ingredient in this product (such as esculin); or if you||
0846|099|P|have any other allergies. This product may contain inactive||
0846|100|P|ingredients (such as latex), which can cause allergic reactions||
0846|101|P|or other problems. Talk to your pharmacist for more details.||
0846|102|P|   Before using this medication, tell your doctor or pharmacist||
0846|103|P|your medical history, especially of: infections (especially||
0846|104|P|fungal/viral infections, tuberculosis, rectal sores/infections),||
0846|105|P|diabetes, eye problems (such as glaucoma), liver disease,||
0846|106|P|stomach/intestinal problems.||
0846|107|P|   Rarely, using corticosteroid medications for a long time can||
0846|108|P|make it more difficult for your body to respond to physical||
0846|109|P|stress. Before having surgery or emergency treatment, or if you||
0846|110|P|get a serious illness/injury, tell your doctor or dentist that||
0846|111|P|you are using this medication or have used this medication within||
0846|112|P|the past few months.||
0846|113|P|   Though it is unlikely, this medication may temporarily slow||
0846|114|P|down a child's growth if used for a long time. See the doctor||
0846|115|P|regularly so your child's height can be checked.||
0846|116|P|   During pregnancy, this medication should be used only when||
0846|117|P|clearly needed. It should not be used for a long time or in large||
0846|118|P|amounts. Discuss the risks and benefits with your doctor.||
0846|119|P|   It is unknown if this medication passes into breast milk.||
0846|120|P|Consult your doctor before breastfeeding.||
0846|121|B|||
0846|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0846|123|I|medications work or increase your risk for serious side effects.||
0846|124|I|This document does not contain all possible drug interactions.||
0846|125|I|Keep a list of all the products you use (including||
0846|126|I|prescription/nonprescription drugs and herbal products) and share||
0846|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
0846|128|I|the dosage of any medicines without your doctor's approval.||
0846|129|I|   Some products that may interact with this drug are:||
0846|130|I|antiplatelet medication (such as clopidogrel), "blood thinners"||
0846|131|I|(such as warfarin), desmopressin.||
0846|132|B|||
0846|133|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0846|134|O|has overdosed and has serious symptoms such as passing out or||
0846|135|O|trouble breathing, call 911. Otherwise, call a poison control||
0846|136|O|center right away. US residents can call 1-800-222-1222. Canada||
0846|137|O|residents can call 1-844-764-7669.||
0846|138|B|||
0846|139|N|NOTES:  Lab and/or medical tests (such as cortisol levels) may be||
0846|140|N|done while you are using this medication. Keep all medical and||
0846|141|N|lab appointments. Consult your doctor for more details.||
0846|142|N|   This medication has been prescribed for your current condition||
0846|143|N|only. Do not use it later for another condition unless told to do||
0846|144|N|so by your doctor. A different medication may be necessary in||
0846|145|N|that case.||
0846|146|B|||
0846|147|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
0846|148|D|unless it is almost time for the next dose. In that case, skip||
0846|149|D|the missed dose. Use your next dose at the regular time. Do not||
0846|150|D|double the dose to catch up.||
0846|151|B|||
0846|152|R|STORAGE:  Store at room temperature. Do not refrigerate. Keep all||
0846|153|R|medications away from children and pets.||
0846|154|R|   Do not flush medications down the toilet or pour them into a||
0846|155|R|drain unless instructed to do so. Properly discard this product||
0846|156|R|when it is expired or no longer needed. Consult your pharmacist||
0846|157|R|or local waste disposal company.||
0846|158|B|||
0846|159|A|Information last revised April 2025.||
0846|160|A|Copyright(c) 2025 First Databank, Inc.||
0846|161|B|||
0847|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0847|002|Z|does NOT have all possible information about this product. This||
0847|003|Z|information does not assure that this product is safe, effective,||
0847|004|Z|or appropriate for you. This information is not individual||
0847|005|Z|medical advice and does not substitute for the advice of your||
0847|006|Z|health care professional. Always ask your health care||
0847|007|Z|professional for complete information about this product and your||
0847|008|Z|specific health needs.||
0847|009|B|||
0847|010|T|LEVORPHANOL - ORAL||
0847|011|F|(lee-VOR-fa-nole)||
0847|012|B|||
0847|013|C|COMMON BRAND NAME(S): Levo-Dromoran||
0847|014|B|||
0847|015|W|WARNING:  Levorphanol has a risk for abuse and addiction, which||
0847|016|W|can lead to overdose and death. Levorphanol may also cause||
0847|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
0847|018|W|your doctor should have you take the smallest dose of levorphanol||
0847|019|W|that works, and take it for the shortest possible time. See also||
0847|020|W|How to Use section for more information about addiction.||
0847|021|W|   Ask your doctor or pharmacist if you should have medication||
0847|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0847|023|W|Teach your family or household members about the signs of an||
0847|024|W|opioid overdose and how to treat it.||
0847|025|W|   The risk for severe breathing problems is higher when you||
0847|026|W|start this medication and after a dose increase, or if you take||
0847|027|W|the wrong dose/strength. Taking this medication with alcohol or||
0847|028|W|other drugs that can cause drowsiness or breathing problems may||
0847|029|W|cause very serious side effects, including death. Be sure you||
0847|030|W|know how to take levorphanol and what other drugs you should||
0847|031|W|avoid taking with it. See also Drug Interactions section. Get||
0847|032|W|medical help right away if any of these very serious side effects||
0847|033|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
0847|034|W|drowsiness/dizziness, difficulty waking up.||
0847|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0847|036|W|or abuse. If someone accidentally swallows this drug, get medical||
0847|037|W|help right away.||
0847|038|W|   Before using this medication, women of childbearing age should||
0847|039|W|talk with their doctor(s) about the risks and benefits. Tell your||
0847|040|W|doctor if you are pregnant or if you plan to become pregnant.||
0847|041|W|During pregnancy, this medication should be used only when||
0847|042|W|clearly needed. It may slightly increase the risk of birth||
0847|043|W|defects if used during the first two months of pregnancy. Also,||
0847|044|W|using it for a long time or in high doses near the expected||
0847|045|W|delivery date may harm the unborn baby. To lessen the risk, take||
0847|046|W|the smallest effective dose for the shortest possible time.||
0847|047|W|Babies born to mothers who use this drug for a long time may||
0847|048|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0847|049|W|doctor right away if you notice any symptoms in your newborn baby||
0847|050|W|such as crying that doesn't stop, slow/shallow breathing,||
0847|051|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0847|052|W|difficulty gaining weight.||
0847|053|B|||
0847|054|U|USES:  This medication is used to treat moderate to severe pain.||
0847|055|U|Levorphanol is an opioid pain reliever. It acts on certain||
0847|056|U|centers in the brain to give you pain relief.||
0847|057|B|||
0847|058|H|HOW TO USE:  Read the Medication Guide provided by your||
0847|059|H|pharmacist before you start taking levorphanol and each time you||
0847|060|H|get a refill. If you have any questions, ask your doctor or||
0847|061|H|pharmacist.||
0847|062|H|   Take this medication by mouth with or without food as directed||
0847|063|H|by your doctor, usually every 6 to 8 hours as needed. If you have||
0847|064|H|nausea, you may take this drug with food, although this may cause||
0847|065|H|your body to absorb less of the drug and get less benefit from||
0847|066|H|it. Ask your doctor or pharmacist about other ways to decrease||
0847|067|H|nausea (such as lying down for 1-2 hours with as little head||
0847|068|H|movement as possible).||
0847|069|H|   The dosage is based on your medical condition, age, and||
0847|070|H|response to treatment. Pain medications work best if they are||
0847|071|H|used as the first signs of pain occur. If you wait until the pain||
0847|072|H|has worsened, the medication may not work as well.||
0847|073|H|   Before you start using this medication, ask your doctor or||
0847|074|H|pharmacist if you should stop or change how you use your other||
0847|075|H|opioid medication(s). Other pain relievers (such as||
0847|076|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
0847|077|H|or pharmacist about using levorphanol safely with other drugs.||
0847|078|H|   Suddenly stopping this medication may cause withdrawal,||
0847|079|H|especially if you have used it for a long time or in high doses.||
0847|080|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0847|081|H|Tell your doctor or pharmacist right away if you have any||
0847|082|H|withdrawal symptoms such as restlessness, mental/mood changes||
0847|083|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0847|084|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0847|085|H|aches, or sudden changes in behavior.||
0847|086|H|   Though it helps many people, this medication may sometimes||
0847|087|H|cause addiction. This risk may be higher if you have a||
0847|088|H|mental/mood disorder or a substance use disorder (such as overuse||
0847|089|H|of or addiction to drugs/alcohol). Take this medication exactly||
0847|090|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0847|091|H|pharmacist for more details.||
0847|092|H|   When used for an extended period, this medication may not work||
0847|093|H|as well and may require different dosing. Talk with your doctor||
0847|094|H|if this medication stops working well.||
0847|095|H|   Tell your doctor if your pain does not get better or if it||
0847|096|H|gets worse, or if you have any new pain.||
0847|097|B|||
0847|098|S|SIDE EFFECTS:  See also Warning section.||
0847|099|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0847|100|S|drowsiness, dry mouth, flushing, or vision problems may occur. If||
0847|101|S|any of these effects last or get worse, tell your doctor or||
0847|102|S|pharmacist promptly.||
0847|103|S|   To prevent constipation, eat dietary fiber, drink enough||
0847|104|S|water, and exercise. You may also need to take a laxative. Ask||
0847|105|S|your pharmacist which type of laxative is right for you.||
0847|106|S|   To reduce the risk of dizziness and lightheadedness, get up||
0847|107|S|slowly when rising from a sitting or lying position.||
0847|108|S|   Remember that this medication has been prescribed because your||
0847|109|S|doctor has judged that the benefit to you is greater than the||
0847|110|S|risk of side effects. Many people using this medication do not||
0847|111|S|have serious side effects.||
0847|112|S|   Tell your doctor right away if you have any serious side||
0847|113|S|effects, including: interrupted breathing during sleep (sleep||
0847|114|S|apnea), mental/mood changes (such as confusion, depression,||
0847|115|S|abnormal thoughts), trouble urinating, fast/slow/irregular||
0847|116|S|heartbeat, severe stomach/abdominal pain, signs of your adrenal||
0847|117|S|glands not working well (such as loss of appetite, unusual||
0847|118|S|tiredness, weight loss), trouble swallowing.||
0847|119|S|   Get medical help right away if you have any very serious side||
0847|120|S|effects, including: slow/shallow breathing, fainting, severe||
0847|121|S|drowsiness/difficulty waking up, seizures.||
0847|122|S|   A very serious allergic reaction to this drug is rare.||
0847|123|S|However, get medical help right away if you notice any symptoms||
0847|124|S|of a serious allergic reaction, including: rash, itching/swelling||
0847|125|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0847|126|S|breathing.||
0847|127|S|   This is not a complete list of possible side effects. If you||
0847|128|S|notice other effects not listed above, contact your doctor or||
0847|129|S|pharmacist.||
0847|130|S|   In the US -||
0847|131|S|   Call your doctor for medical advice about side effects. You||
0847|132|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0847|133|S|www.fda.gov/medwatch.||
0847|134|S|   In Canada - Call your doctor for medical advice about side||
0847|135|S|effects. You may report side effects to Health Canada at||
0847|136|S|1-866-234-2345.||
0847|137|B|||
0847|138|P|PRECAUTIONS:  Before taking levorphanol, tell your doctor or||
0847|139|P|pharmacist if you are allergic to it; or if you have any other||
0847|140|P|allergies. This product may contain inactive ingredients, which||
0847|141|P|can cause allergic reactions or other problems. Talk to your||
0847|142|P|pharmacist for more details.||
0847|143|P|   Before using this medication, tell your doctor or pharmacist||
0847|144|P|your medical history, especially of: brain disorders (such as||
0847|145|P|seizures, head injury, tumor, increased intracranial pressure),||
0847|146|P|heart problems (such as irregular heartbeat), low blood pressure,||
0847|147|P|certain bowel diseases (such as paralytic ileus, toxic||
0847|148|P|megacolon), breathing problems (such as asthma, chronic||
0847|149|P|obstructive pulmonary disease-COPD, emphysema, low oxygen/high||
0847|150|P|carbon dioxide in the blood, sleep apnea), disease of the||
0847|151|P|pancreas (such as pancreatitis), mental/mood disorders (such as||
0847|152|P|toxic psychosis), a certain spinal problem (kyphoscoliosis),||
0847|153|P|gallbladder disease, personal or family history of a substance||
0847|154|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
0847|155|P|kidney disease, liver disease, adrenal gland problem (such as||
0847|156|P|Addison's disease), difficulty urinating (such as due to enlarged||
0847|157|P|prostate or urethral stricture), underactive thyroid||
0847|158|P|(hypothyroidism).||
0847|159|P|   Before having surgery, tell your doctor or dentist about all||
0847|160|P|the products you use (including prescription drugs,||
0847|161|P|nonprescription drugs, and herbal products).||
0847|162|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0847|163|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0847|164|P|machinery, or do anything that needs alertness until you can do||
0847|165|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0847|166|P|are using marijuana (cannabis).||
0847|167|P|   Older adults may be more sensitive to the side effects of this||
0847|168|P|drug, especially confusion, dizziness, drowsiness, and||
0847|169|P|slow/shallow breathing.||
0847|170|P|   During pregnancy, this medication should be used only when||
0847|171|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0847|172|P|benefits with your doctor. (See also Warning section.)||
0847|173|P|   Based on information from related drugs, this medication may||
0847|174|P|pass into breast milk. Consult your doctor before breastfeeding.||
0847|175|B|||
0847|176|I|DRUG INTERACTIONS:  See also Warning section.||
0847|177|I|   Drug interactions may change how your medications work or||
0847|178|I|increase your risk for serious side effects. This document does||
0847|179|I|not contain all possible drug interactions. Keep a list of all||
0847|180|I|the products you use (including prescription/nonprescription||
0847|181|I|drugs and herbal products) and share it with your doctor and||
0847|182|I|pharmacist. Do not start, stop, or change the dosage of any||
0847|183|I|medicines without your doctor's approval.||
0847|184|I|   Some products that may interact with this drug include:||
0847|185|I|certain pain medications (mixed opioid agonist-antagonists such||
0847|186|I|as butorphanol, nalbuphine, pentazocine), cimetidine, MAO||
0847|187|I|inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue,||
0847|188|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0847|189|I|selegiline, tranylcypromine), naltrexone, samidorphan.||
0847|190|I|   The risk of serious side effects (such as slow/shallow||
0847|191|I|breathing, severe drowsiness/dizziness) may be increased if this||
0847|192|I|medication is taken with other products that may also cause||
0847|193|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0847|194|I|if you are taking other products such as other opioid pain or||
0847|195|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0847|196|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0847|197|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0847|198|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0847|199|I|cetirizine, diphenhydramine).||
0847|200|I|   Check the labels on all your medicines (such as allergy or||
0847|201|I|cough-and-cold products) because they may contain ingredients||
0847|202|I|that cause drowsiness. Ask your pharmacist about using those||
0847|203|I|products safely.||
0847|204|I|   This medication may interfere with certain lab tests (such as||
0847|205|I|amylase/lipase levels), possibly causing false test results. Make||
0847|206|I|sure lab personnel and all your doctors know you use this drug.||
0847|207|B|||
0847|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0847|209|O|as passing out or trouble breathing, give them naloxone or||
0847|210|O|nalmefene if available, then call 911. If the person is awake and||
0847|211|O|has no symptoms, call a poison control center right away. US||
0847|212|O|residents can call 1-800-222-1222. Canada residents can call||
0847|213|O|1-844-764-7669. Symptoms of overdose may include: slow breathing,||
0847|214|O|slow heartbeat, weak muscles, extreme drowsiness, coma.||
0847|215|B|||
0847|216|N|NOTES:  Do not share this medication with others. Sharing it is||
0847|217|N|against the law.||
0847|218|N|   This medication has been prescribed for your current condition||
0847|219|N|only. Do not use it later for another condition unless told to do||
0847|220|N|so by your doctor. A different medication may be necessary in||
0847|221|N|that case.||
0847|222|B|||
0847|223|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0847|224|D|remember. If it is near the time of the next dose, skip the||
0847|225|D|missed dose. Take your next dose at the regular time. Do not||
0847|226|D|double the dose to catch up.||
0847|227|B|||
0847|228|R|STORAGE:  Store at room temperature away from light and moisture.||
0847|229|R|Do not store in the bathroom. Keep all medications away from||
0847|230|R|children and pets.||
0847|231|R|   Do not flush medications down the toilet or pour them into a||
0847|232|R|drain unless instructed to do so. Properly discard this product||
0847|233|R|when it is expired or no longer needed. Consult your pharmacist||
0847|234|R|or local waste disposal company.||
0847|235|B|||
0847|236|A|Information last revised August 2025.||
0847|237|A|Copyright(c) 2025 First Databank, Inc.||
0847|238|B|||
0848|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0848|002|Z|does NOT have all possible information about this product. This||
0848|003|Z|information does not assure that this product is safe, effective,||
0848|004|Z|or appropriate for you. This information is not individual||
0848|005|Z|medical advice and does not substitute for the advice of your||
0848|006|Z|health care professional. Always ask your health care||
0848|007|Z|professional for complete information about this product and your||
0848|008|Z|specific health needs.||
0848|009|B|||
0848|010|T|ISOSORBIDE DINITRATE/HYDRALAZINE - ORAL||
0848|011|F|(EYE-soe-SOR-bide dye-NYE-trate/hye-DRAL-a-zeen)||
0848|012|B|||
0848|013|C|COMMON BRAND NAME(S): Bidil||
0848|014|B|||
0848|015|U|USES:  This medication contains 2 drugs (hydralazine and||
0848|016|U|isosorbide dinitrate) and is used with other medications to treat||
0848|017|U|heart failure. Both drugs are known as vasodilators. They work by||
0848|018|U|relaxing and widening blood vessels so blood can flow more easily||
0848|019|U|to the heart.||
0848|020|B|||
0848|021|H|HOW TO USE:  Take this medication by mouth as directed by your||
0848|022|H|doctor, usually 3 times daily.||
0848|023|H|   The dosage is based on your medical condition and response to||
0848|024|H|treatment. Your doctor may start you at a low dose and gradually||
0848|025|H|increase your dose. Follow your doctor's instructions carefully.||
0848|026|H|   Use this medication regularly to get the most benefit from it.||
0848|027|H|To help you remember, take it at the same times each day.||
0848|028|H|   Do not stop taking this medication without consulting your||
0848|029|H|doctor. Some conditions may become worse when the drug is||
0848|030|H|suddenly stopped. Your dose may need to be gradually decreased.||
0848|031|H|   Tell your doctor if your condition gets worse.||
0848|032|B|||
0848|033|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, nausea, and||
0848|034|S|flushing may occur as your body adjusts to the medication. If any||
0848|035|S|of these effects last or get worse, tell your doctor or||
0848|036|S|pharmacist promptly.||
0848|037|S|   Headache is often a sign that this medication is working. Your||
0848|038|S|doctor may recommend treating headaches with an over-the-counter||
0848|039|S|pain reliever (such as acetaminophen). If the headaches continue||
0848|040|S|or become severe, tell your doctor promptly.||
0848|041|S|   To reduce the risk of dizziness and lightheadedness, get up||
0848|042|S|slowly when rising from a sitting or lying position.||
0848|043|S|   Remember that this medication has been prescribed because your||
0848|044|S|doctor has judged that the benefit to you is greater than the||
0848|045|S|risk of side effects. Many people using this medication do not||
0848|046|S|have serious side effects.||
0848|047|S|   This medication may rarely cause nerve problems. Tell your||
0848|048|S|doctor promptly if you experience numbness or tingling. Your||
0848|049|S|doctor may recommend a vitamin B6 supplement (pyridoxine).||
0848|050|S|   Tell your doctor right away if you have any serious side||
0848|051|S|effects, including: severe tiredness, aching/swollen joints, rash||
0848|052|S|on nose and cheeks, swollen lymph nodes, signs of kidney problems||
0848|053|S|(such as change in the amount of urine, bloody/pink urine), signs||
0848|054|S|of infection (such as sore throat that doesn't go away, fever,||
0848|055|S|chills), easy bruising/bleeding, fainting,||
0848|056|S|fast/irregular/pounding heartbeat.||
0848|057|S|   Get medical help right away if you have any very serious side||
0848|058|S|effects, including: chest/jaw/left arm pain.||
0848|059|S|   A very serious allergic reaction to this drug is rare.||
0848|060|S|However, get medical help right away if you notice any symptoms||
0848|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0848|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0848|063|S|breathing.||
0848|064|S|   This is not a complete list of possible side effects. If you||
0848|065|S|notice other effects not listed above, contact your doctor or||
0848|066|S|pharmacist.||
0848|067|S|   In the US -||
0848|068|S|   Call your doctor for medical advice about side effects. You||
0848|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0848|070|S|www.fda.gov/medwatch.||
0848|071|S|   In Canada - Call your doctor for medical advice about side||
0848|072|S|effects. You may report side effects to Health Canada at||
0848|073|S|1-866-234-2345.||
0848|074|B|||
0848|075|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0848|076|P|pharmacist if you are allergic to either isosorbide dinitrate or||
0848|077|P|hydralazine; or to similar drugs (such as isosorbide mononitrate,||
0848|078|P|nitroglycerin); or if you have any other allergies. This product||
0848|079|P|may contain inactive ingredients, which can cause allergic||
0848|080|P|reactions or other problems. Talk to your pharmacist for more||
0848|081|P|details.||
0848|082|P|   Before using this medication, tell your doctor or pharmacist||
0848|083|P|your medical history, especially of: other heart problems (such||
0848|084|P|as recent heart attack, rheumatic heart disease of the mitral||
0848|085|P|valve), previous stroke, low blood pressure, blood vessel||
0848|086|P|problems, dehydration, recent head injury, anemia, kidney||
0848|087|P|problems.||
0848|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0848|089|P|can make you more dizzy. Do not drive, use machinery, or do||
0848|090|P|anything that needs alertness until you can do it safely. Limit||
0848|091|P|alcoholic beverages. Talk to your doctor if you are using||
0848|092|P|marijuana (cannabis).||
0848|093|P|   Before having surgery, tell your doctor or dentist about all||
0848|094|P|the products you use (including prescription drugs,||
0848|095|P|nonprescription drugs, and herbal products).||
0848|096|P|   Older adults may be more sensitive to the side effects of this||
0848|097|P|drug, especially dizziness and lightheadedness, which could||
0848|098|P|increase the risk of falls.||
0848|099|P|   During pregnancy, this medication should be used only when||
0848|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0848|101|P|   Hydralazine passes into breast milk. It is unknown if||
0848|102|P|isosorbide dinitrate passes into breast milk. Consult your doctor||
0848|103|P|before breastfeeding.||
0848|104|B|||
0848|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0848|106|I|medications work or increase your risk for serious side effects.||
0848|107|I|This document does not contain all possible drug interactions.||
0848|108|I|Keep a list of all the products you use (including||
0848|109|I|prescription/nonprescription drugs and herbal products) and share||
0848|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0848|111|I|the dosage of any medicines without your doctor's approval.||
0848|112|I|   Some products that may interact with this drug include:||
0848|113|I|certain drugs to treat migraine headaches (ergot alkaloids such||
0848|114|I|as ergotamine), drugs to treat erectile dysfunction-ED or||
0848|115|I|pulmonary hypertension (such as sildenafil, tadalafil), MAO||
0848|116|I|inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue,||
0848|117|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0848|118|I|selegiline, tranylcypromine), riociguat, vericiguat.||
0848|119|I|   Some products have ingredients that could worsen your heart||
0848|120|I|failure. Tell your pharmacist what products you are using, and||
0848|121|I|ask how to use them safely (especially cough-and-cold products,||
0848|122|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0848|123|I|   Isosorbide dinitrate is very similar to isosorbide||
0848|124|I|mononitrate. Do not use medications containing isosorbide||
0848|125|I|mononitrate while using isosorbide dinitrate.||
0848|126|I|   This medication may interfere with certain lab tests (such as||
0848|127|I|blood cholesterol levels), possibly causing false test results.||
0848|128|I|Make sure lab personnel and all your doctors know you use this||
0848|129|I|drug.||
0848|130|B|||
0848|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0848|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0848|133|O|poison control center right away. US residents can call||
0848|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0848|135|O|Symptoms of overdose may include: slow heartbeat, vision changes,||
0848|136|O|severe nausea/vomiting, sweating, cold/clammy skin, bluish||
0848|137|O|fingers/toes/lips, chest/jaw/left arm pain.||
0848|138|B|||
0848|139|N|NOTES:  Do not share this medication with others.||
0848|140|N|   Lab and/or medical tests (such as complete blood count, blood||
0848|141|N|pressure monitoring) should be done while you are taking this||
0848|142|N|medication. Keep all medical and lab appointments. Consult your||
0848|143|N|doctor for more details.||
0848|144|N|   Lifestyle changes such as exercise and dietary changes may||
0848|145|N|help this drug work better. Talk to your doctor or pharmacist||
0848|146|N|about lifestyle changes that might benefit you.||
0848|147|B|||
0848|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0848|149|D|remember. If it is near the time of the next dose, skip the||
0848|150|D|missed dose. Take your next dose at the regular time. Do not||
0848|151|D|double the dose to catch up.||
0848|152|B|||
0848|153|R|STORAGE:  Store at room temperature away from light and moisture.||
0848|154|R|Do not store in the bathroom. Keep all medications away from||
0848|155|R|children and pets.||
0848|156|R|   Do not flush medications down the toilet or pour them into a||
0848|157|R|drain unless instructed to do so. Properly discard this product||
0848|158|R|when it is expired or no longer needed. Consult your pharmacist||
0848|159|R|or local waste disposal company.||
0848|160|B|||
0848|161|A|Information last revised April 2025.||
0848|162|A|Copyright(c) 2025 First Databank, Inc.||
0848|163|B|||
0850|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0850|002|Z|does NOT have all possible information about this product. This||
0850|003|Z|information does not assure that this product is safe, effective,||
0850|004|Z|or appropriate for you. This information is not individual||
0850|005|Z|medical advice and does not substitute for the advice of your||
0850|006|Z|health care professional. Always ask your health care||
0850|007|Z|professional for complete information about this product and your||
0850|008|Z|specific health needs.||
0850|009|B|||
0850|010|T|HYDROMORPHONE - ORAL||
0850|011|F|(hye-droe-MOR-fone)||
0850|012|B|||
0850|013|C|COMMON BRAND NAME(S): Dilaudid||
0850|014|B|||
0850|015|W|WARNING:  Hydromorphone has a risk for abuse and addiction, which||
0850|016|W|can lead to overdose and death. Hydromorphone may also cause||
0850|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
0850|018|W|your doctor should have you take the smallest dose of||
0850|019|W|hydromorphone that works, and take it for the shortest possible||
0850|020|W|time. Also, if you are taking the liquid form of this medication,||
0850|021|W|follow the instructions carefully from your doctor or pharmacist||
0850|022|W|to measure out the proper dose. This will help to decrease the||
0850|023|W|risk of serious side effects. See also How to Use section for||
0850|024|W|more information about addiction and how to properly measure the||
0850|025|W|dose of the liquid.||
0850|026|W|   Ask your doctor or pharmacist if you should have medication||
0850|027|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0850|028|W|Teach your family or household members about the signs of an||
0850|029|W|opioid overdose and how to treat it.||
0850|030|W|   The risk for severe breathing problems is higher when you||
0850|031|W|start this medication and after a dose increase, or if you take||
0850|032|W|the wrong dose/strength. Taking this medication with alcohol or||
0850|033|W|other drugs that can cause drowsiness or breathing problems may||
0850|034|W|cause very serious side effects, including death. Be sure you||
0850|035|W|know how to take hydromorphone and what other drugs you should||
0850|036|W|avoid taking with it. See also Drug Interactions section. Get||
0850|037|W|medical help right away if any of these very serious side effects||
0850|038|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
0850|039|W|drowsiness/dizziness, difficulty waking up.||
0850|040|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0850|041|W|or abuse. If someone accidentally swallows this drug, get medical||
0850|042|W|help right away.||
0850|043|W|   Before using this medication, women of childbearing age should||
0850|044|W|talk with their doctor(s) about the risks and benefits. Tell your||
0850|045|W|doctor if you are pregnant or if you plan to become pregnant.||
0850|046|W|During pregnancy, this medication should be used only when||
0850|047|W|clearly needed. It may slightly increase the risk of birth||
0850|048|W|defects if used during the first two months of pregnancy. Also,||
0850|049|W|using it for a long time or in high doses near the expected||
0850|050|W|delivery date may harm the unborn baby. To lessen the risk, take||
0850|051|W|the smallest effective dose for the shortest possible time.||
0850|052|W|Babies born to mothers who use this drug for a long time may||
0850|053|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0850|054|W|doctor right away if you notice any symptoms in your newborn baby||
0850|055|W|such as crying that doesn't stop, slow/shallow breathing,||
0850|056|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0850|057|W|difficulty gaining weight.||
0850|058|B|||
0850|059|U|USES:  This medication is used to help relieve moderate to severe||
0850|060|U|pain. Hydromorphone belongs to a class of drugs known as opioid||
0850|061|U|analgesics. It works in the brain to change how your body feels||
0850|062|U|and responds to pain.||
0850|063|B|||
0850|064|H|HOW TO USE:  Read the Medication Guide provided by your||
0850|065|H|pharmacist before you start taking hydromorphone and each time||
0850|066|H|you get a refill. If you have any questions, ask your doctor or||
0850|067|H|pharmacist.||
0850|068|H|   Take this medication by mouth as directed by your doctor. You||
0850|069|H|may take this drug with or without food. If you have nausea, it||
0850|070|H|may help to take this drug with food. Ask your doctor or||
0850|071|H|pharmacist about other ways to decrease nausea (such as lying||
0850|072|H|down for 1 to 2 hours with as little head movement as possible).||
0850|073|H|   If you are using the liquid form of this medication, carefully||
0850|074|H|measure the dose using a special measuring device/spoon. Do not||
0850|075|H|use a household spoon because you may not get the correct dose.||
0850|076|H|Do not confuse the dose of hydromorphone liquid in milligrams||
0850|077|H|(mg) with the dose in milliliters (mL). Ask your pharmacist or||
0850|078|H|doctor if you are not sure how to check or measure the dose. If||
0850|079|H|your liquid is a suspension, shake the bottle well before each||
0850|080|H|dose.||
0850|081|H|   The dosage is based on your medical condition and response to||
0850|082|H|treatment. Do not increase your dose, take the medication more||
0850|083|H|often, or take it for a longer time than prescribed. Properly||
0850|084|H|stop the medication when so directed.||
0850|085|H|   Pain medications work best if they are used when the first||
0850|086|H|signs of pain occur. If you wait until the pain has worsened, the||
0850|087|H|medication may not work as well.||
0850|088|H|   If you have ongoing pain (such as due to cancer), your doctor||
0850|089|H|may direct you to also take long-acting opioid medications. In||
0850|090|H|that case, this medication might be used for sudden||
0850|091|H|(breakthrough) pain only as needed. Other pain relievers (such as||
0850|092|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
0850|093|H|or pharmacist about using hydromorphone safely with other drugs.||
0850|094|H|   Suddenly stopping this medication may cause withdrawal,||
0850|095|H|especially if you have used it for a long time or in high doses.||
0850|096|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0850|097|H|Tell your doctor or pharmacist right away if you have any||
0850|098|H|withdrawal symptoms such as restlessness, mental/mood changes||
0850|099|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0850|100|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0850|101|H|aches, or sudden changes in behavior.||
0850|102|H|   When this medication is used for a long time, it may not work||
0850|103|H|as well. Talk with your doctor if this medication stops working||
0850|104|H|well.||
0850|105|H|   Though it helps many people, this medication may sometimes||
0850|106|H|cause addiction. This risk may be higher if you have a||
0850|107|H|mental/mood disorder or a substance use disorder (such as overuse||
0850|108|H|of or addiction to drugs/alcohol). Take this medication exactly||
0850|109|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0850|110|H|pharmacist for more details.||
0850|111|H|   Tell your doctor if your pain does not get better or if it||
0850|112|H|gets worse, or if you have any new pain.||
0850|113|B|||
0850|114|S|SIDE EFFECTS:  See also Warning section.||
0850|115|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0850|116|S|drowsiness, sweating, flushing, or dry mouth may occur. Some of||
0850|117|S|these side effects may decrease after you have been using this||
0850|118|S|medication for a while. If any of these effects last or get||
0850|119|S|worse, tell your doctor or pharmacist promptly.||
0850|120|S|   To prevent constipation, eat dietary fiber, drink enough||
0850|121|S|water, and exercise. You may also need to take a laxative. Ask||
0850|122|S|your pharmacist which type of laxative is right for you.||
0850|123|S|   To reduce the risk of dizziness and lightheadedness, get up||
0850|124|S|slowly when rising from a sitting or lying position.||
0850|125|S|   Remember that this medication has been prescribed because your||
0850|126|S|doctor has judged that the benefit to you is greater than the||
0850|127|S|risk of side effects. Many people using this medication do not||
0850|128|S|have serious side effects.||
0850|129|S|   Tell your doctor right away if you have any serious side||
0850|130|S|effects, including: interrupted breathing during sleep (sleep||
0850|131|S|apnea), mental/mood changes (such as agitation, confusion,||
0850|132|S|hallucinations), severe stomach/abdominal pain, difficulty||
0850|133|S|urinating, signs of your adrenal glands not working well (such as||
0850|134|S|loss of appetite, unusual tiredness, weight loss), trouble||
0850|135|S|swallowing.||
0850|136|S|   Get medical help right away if you have any very serious side||
0850|137|S|effects, including: fainting, seizure, slow/shallow breathing,||
0850|138|S|severe drowsiness/difficulty waking up.||
0850|139|S|   A very serious allergic reaction to this drug is rare.||
0850|140|S|However, get medical help right away if you notice any symptoms||
0850|141|S|of a serious allergic reaction, including: rash, itching/swelling||
0850|142|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0850|143|S|breathing.||
0850|144|S|   This is not a complete list of possible side effects. If you||
0850|145|S|notice other effects not listed above, contact your doctor or||
0850|146|S|pharmacist.||
0850|147|S|   In the US -||
0850|148|S|   Call your doctor for medical advice about side effects. You||
0850|149|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0850|150|S|www.fda.gov/medwatch.||
0850|151|S|   In Canada - Call your doctor for medical advice about side||
0850|152|S|effects. You may report side effects to Health Canada at||
0850|153|S|1-866-234-2345.||
0850|154|B|||
0850|155|P|PRECAUTIONS:  Before taking hydromorphone, tell your doctor or||
0850|156|P|pharmacist if you are allergic to it; or to hydrocodone; or if||
0850|157|P|you have any other allergies. This product may contain inactive||
0850|158|P|ingredients (such as sulfites), which can cause allergic||
0850|159|P|reactions or other problems. Talk to your pharmacist for more||
0850|160|P|details.||
0850|161|P|   Before using this medication, tell your doctor or pharmacist||
0850|162|P|your medical history, especially of: brain disorders (such as||
0850|163|P|head injury, tumor, seizures), breathing problems (such as||
0850|164|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0850|165|P|kidney disease, liver disease, mental/mood disorders (such as||
0850|166|P|confusion, depression), personal or family history of a substance||
0850|167|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
0850|168|P|stomach/intestinal problems (such as blockage, constipation,||
0850|169|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
0850|170|P|(such as due to enlarged prostate), gallbladder disease, disease||
0850|171|P|of the pancreas (pancreatitis), underactive thyroid||
0850|172|P|(hypothyroidism), a certain spinal problem (kyphoscoliosis),||
0850|173|P|adrenal gland problem (such as Addison's disease).||
0850|174|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0850|175|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0850|176|P|machinery, or do anything that needs alertness until you can do||
0850|177|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0850|178|P|are using marijuana (cannabis).||
0850|179|P|   Liquid products may contain sugar. Caution is advised if you||
0850|180|P|have diabetes, or any other condition that requires you to||
0850|181|P|limit/avoid sugar in your diet. Ask your doctor or pharmacist||
0850|182|P|about using this product safely.||
0850|183|P|   Before having surgery, tell your doctor or dentist about all||
0850|184|P|the products you use (including prescription drugs,||
0850|185|P|nonprescription drugs, and herbal products).||
0850|186|P|   Older adults may be more sensitive to the side effects of this||
0850|187|P|drug, especially confusion, dizziness, drowsiness, and||
0850|188|P|slow/shallow breathing.||
0850|189|P|   During pregnancy, this medication should be used only when||
0850|190|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0850|191|P|benefits with your doctor. (See also Warning section.)||
0850|192|P|   This drug passes into breast milk and may have undesirable||
0850|193|P|effects on a nursing infant. Tell the doctor right away if your||
0850|194|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0850|195|P|breathing. Consult your doctor before breastfeeding.||
0850|196|B|||
0850|197|I|DRUG INTERACTIONS:  See also Warning section.||
0850|198|I|   Drug interactions may change how your medications work or||
0850|199|I|increase your risk for serious side effects. This document does||
0850|200|I|not contain all possible drug interactions. Keep a list of all||
0850|201|I|the products you use (including prescription/nonprescription||
0850|202|I|drugs and herbal products) and share it with your doctor and||
0850|203|I|pharmacist. Do not start, stop, or change the dosage of any||
0850|204|I|medicines without your doctor's approval.||
0850|205|I|   Some products that may interact with this drug include:||
0850|206|I|certain pain medications (mixed opioid agonist/antagonists such||
0850|207|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0850|208|I|samidorphan.||
0850|209|I|   The risk of serious side effects (such as slow/shallow||
0850|210|I|breathing, severe drowsiness/dizziness) may be increased if this||
0850|211|I|medication is taken with other products that may also cause||
0850|212|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0850|213|I|if you are taking other products such as other opioid pain or||
0850|214|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0850|215|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0850|216|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0850|217|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0850|218|I|cetirizine, diphenhydramine).||
0850|219|I|   Check the labels on all your medicines (such as allergy or||
0850|220|I|cough-and-cold products) because they may contain ingredients||
0850|221|I|that cause drowsiness. Ask your pharmacist about using those||
0850|222|I|products safely.||
0850|223|I|   This medication may interfere with certain lab tests (such as||
0850|224|I|amylase/lipase levels), possibly causing false test results. Make||
0850|225|I|sure lab personnel and all your doctors know you use this drug.||
0850|226|B|||
0850|227|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0850|228|O|as passing out or trouble breathing, give them naloxone or||
0850|229|O|nalmefene if available, then call 911. If the person is awake and||
0850|230|O|has no symptoms, call a poison control center right away. US||
0850|231|O|residents can call 1-800-222-1222. Canada residents can call||
0850|232|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0850|233|O|breathing, slow heartbeat, coma.||
0850|234|B|||
0850|235|N|NOTES:  Do not share this medication with others. Sharing it is||
0850|236|N|against the law.||
0850|237|N|   This medication has been prescribed for your current condition||
0850|238|N|only. Do not use it later for another condition unless told to do||
0850|239|N|so by your doctor. A different medication may be necessary in||
0850|240|N|that case.||
0850|241|B|||
0850|242|D|MISSED DOSE:  If you are taking this medication on a regular||
0850|243|D|schedule and miss a dose, take it as soon as you remember. If it||
0850|244|D|is near the time of the next dose, skip the missed dose. Take||
0850|245|D|your next dose at the regular time. Do not double the dose to||
0850|246|D|catch up.||
0850|247|B|||
0850|248|R|STORAGE:  Store at room temperature away from light and moisture.||
0850|249|R|Do not store in the bathroom. Keep all medications away from||
0850|250|R|children and pets. See also Warning section.||
0850|251|R|   Do not flush medications down the toilet or pour them into a||
0850|252|R|drain unless instructed to do so. Properly discard this product||
0850|253|R|when it is expired or no longer needed. For more details, read||
0850|254|R|the Medication Guide, or consult your pharmacist or local waste||
0850|255|R|disposal company.||
0850|256|B|||
0850|257|A|Information last revised August 2025.||
0850|258|A|Copyright(c) 2025 First Databank, Inc.||
0850|259|B|||
0851|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0851|002|Z|does NOT have all possible information about this product. This||
0851|003|Z|information does not assure that this product is safe, effective,||
0851|004|Z|or appropriate for you. This information is not individual||
0851|005|Z|medical advice and does not substitute for the advice of your||
0851|006|Z|health care professional. Always ask your health care||
0851|007|Z|professional for complete information about this product and your||
0851|008|Z|specific health needs.||
0851|009|B|||
0851|010|T|HYDROMORPHONE SUSTAINED-RELEASE - ORAL||
0851|011|F|(hye-droe-MOR-fone)||
0851|012|B|||
0851|013|W|WARNING:  Hydromorphone has a risk for abuse and addiction, which||
0851|014|W|can lead to overdose and death. Hydromorphone may also cause||
0851|015|W|severe, possibly fatal, breathing problems. To lower your risk,||
0851|016|W|your doctor should have you take the smallest dose of||
0851|017|W|hydromorphone that works, and take it for the shortest possible||
0851|018|W|time. See also How to Use section for more information about||
0851|019|W|addiction.||
0851|020|W|   Ask your doctor or pharmacist if you should have medication||
0851|021|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0851|022|W|Teach your family or household members about the signs of an||
0851|023|W|opioid overdose and how to treat it.||
0851|024|W|   The risk for severe breathing problems is higher when you||
0851|025|W|start this medication and after a dose increase, or if you take||
0851|026|W|the wrong dose/strength. Taking this medication with alcohol or||
0851|027|W|other drugs that can cause drowsiness or breathing problems may||
0851|028|W|cause very serious side effects, including death. Be sure you||
0851|029|W|know how to take hydromorphone and what other drugs you should||
0851|030|W|avoid taking with it. See also How to Use and Drug Interactions||
0851|031|W|sections. Get medical help right away if any of these very||
0851|032|W|serious side effects occur: slow/shallow breathing, unusual||
0851|033|W|lightheadedness, severe drowsiness/dizziness, difficulty waking||
0851|034|W|up.||
0851|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0851|036|W|or abuse. If someone accidentally swallows this drug, get medical||
0851|037|W|help right away.||
0851|038|W|   Before using this medication, women of childbearing age should||
0851|039|W|talk with their doctor(s) about the risks and benefits. Tell your||
0851|040|W|doctor if you are pregnant or if you plan to become pregnant.||
0851|041|W|During pregnancy, this medication should be used only when||
0851|042|W|clearly needed. It may slightly increase the risk of birth||
0851|043|W|defects if used during the first two months of pregnancy. Also,||
0851|044|W|using it for a long time or in high doses near the expected||
0851|045|W|delivery date may harm the unborn baby. To lessen the risk, take||
0851|046|W|the smallest effective dose for the shortest possible time.||
0851|047|W|Babies born to mothers who use this drug for a long time may||
0851|048|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0851|049|W|doctor right away if you notice any symptoms in your newborn baby||
0851|050|W|such as crying that doesn't stop, slow/shallow breathing,||
0851|051|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0851|052|W|difficulty gaining weight.||
0851|053|B|||
0851|054|U|USES:  This medication is used to treat severe ongoing pain||
0851|055|U|(usually lasting longer than a few days). It acts on certain||
0851|056|U|centers in the brain to give you pain relief. This medication is||
0851|057|U|a long-acting opioid pain reliever.||
0851|058|U|   You should use the stronger forms of this medication (18||
0851|059|U|milligrams or more per capsule) only if you have already been||
0851|060|U|regularly taking moderate to large amounts of a powerful opioid||
0851|061|U|medication (such as morphine, oxycodone). A person who has not||
0851|062|U|been taking powerful opioids regularly can develop serious||
0851|063|U|(possibly fatal) breathing problems (such as very slow/shallow||
0851|064|U|breathing) if they take these strong capsules.||
0851|065|U|   Do not use the sustained-release form of hydromorphone to||
0851|066|U|relieve pain that is mild or that will go away in a few days.||
0851|067|U|This medication is not for occasional ("as needed") use.||
0851|068|B|||
0851|069|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0851|070|H|from your pharmacist before you start taking hydromorphone and||
0851|071|H|each time you get a refill. If you have any questions, ask your||
0851|072|H|doctor or pharmacist.||
0851|073|H|   Take this medication by mouth with or without food as directed||
0851|074|H|by your doctor, usually every 12 hours. Take this medication on a||
0851|075|H|regular schedule as directed by your doctor, not as needed for||
0851|076|H|sudden (breakthrough) pain. If you have nausea, it may help to||
0851|077|H|take this drug with food. Ask your doctor or pharmacist about||
0851|078|H|other ways to decrease nausea (such as lying down for 1 to 2||
0851|079|H|hours with as little head movement as possible).||
0851|080|H|   Swallow the capsules whole. Do not crush, chew, or dissolve||
0851|081|H|the capsules or their contents. Doing so can destroy the long||
0851|082|H|action of the drug and may lead to the release of a very large||
0851|083|H|(possibly fatal) amount of drug into your body.||
0851|084|H|   If you are an adult and have trouble swallowing the capsule,||
0851|085|H|you may open the capsule and carefully sprinkle its contents on a||
0851|086|H|spoonful of soft, cool food (for example, applesauce) just before||
0851|087|H|you take it. Swallow all of the drug/food mixture right away||
0851|088|H|without chewing. Then rinse your mouth and swallow the rinse||
0851|089|H|liquid to make sure that you have swallowed all of the medicine.||
0851|090|H|Do not chew the mixture or prepare a supply in advance.||
0851|091|H|   Children should not be given this medication by opening the||
0851|092|H|capsules and sprinkling it on applesauce. There is a risk that a||
0851|093|H|child may chew the drug/food mixture, which can result in a fatal||
0851|094|H|overdose of hydromorphone. Talk to your doctor or pharmacist for||
0851|095|H|more details.||
0851|096|H|   The dosage is based on your medical condition and response to||
0851|097|H|treatment. Do not increase your dose, take the medication more||
0851|098|H|often, or take it for a longer time than prescribed. Properly||
0851|099|H|stop the medication when so directed.||
0851|100|H|   Before you start using this medication, ask your doctor or||
0851|101|H|pharmacist if you should stop or change how you use your other||
0851|102|H|opioid medication(s). Other pain relievers (such as||
0851|103|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
0851|104|H|or pharmacist about using hydromorphone safely with other drugs.||
0851|105|H|   Suddenly stopping this medication may cause withdrawal,||
0851|106|H|especially if you have used it for a long time or in high doses.||
0851|107|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0851|108|H|Tell your doctor or pharmacist right away if you have any||
0851|109|H|withdrawal symptoms such as restlessness, mental/mood changes||
0851|110|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0851|111|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0851|112|H|aches, or sudden changes in behavior.||
0851|113|H|   When this medication is used for a long time, it may not work||
0851|114|H|as well. Talk with your doctor if this medication stops working||
0851|115|H|well.||
0851|116|H|   Though it helps many people, this medication may sometimes||
0851|117|H|cause addiction. This risk may be higher if you have a||
0851|118|H|mental/mood disorder or a substance use disorder (such as overuse||
0851|119|H|of or addiction to drugs/alcohol). Take this medication exactly||
0851|120|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0851|121|H|pharmacist for more details.||
0851|122|H|   Tell your doctor if your pain does not get better or if it||
0851|123|H|gets worse, or if you have any new pain.||
0851|124|B|||
0851|125|S|SIDE EFFECTS:  See also Warning section.||
0851|126|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0851|127|S|drowsiness, increased sweating, or dry mouth may occur. If any of||
0851|128|S|these effects last or get worse, tell your doctor or pharmacist||
0851|129|S|promptly.||
0851|130|S|   To prevent constipation, eat dietary fiber, drink enough||
0851|131|S|water, and exercise. You may also need to take a laxative. Ask||
0851|132|S|your pharmacist which type of laxative is right for you.||
0851|133|S|   To reduce the risk of dizziness and lightheadedness, get up||
0851|134|S|slowly when rising from a sitting or lying position.||
0851|135|S|   Remember that this medication has been prescribed because your||
0851|136|S|doctor has judged that the benefit to you is greater than the||
0851|137|S|risk of side effects. Many people using this medication do not||
0851|138|S|have serious side effects.||
0851|139|S|   Tell your doctor right away if you have any serious side||
0851|140|S|effects, including: interrupted breathing during sleep (sleep||
0851|141|S|apnea), mental/mood changes (such as agitation, hallucinations,||
0851|142|S|confusion), difficulty urinating, vision changes, slow/fast||
0851|143|S|heartbeat, severe stomach/abdominal pain, signs of your adrenal||
0851|144|S|glands not working well (such as loss of appetite, unusual||
0851|145|S|tiredness, weight loss), trouble swallowing.||
0851|146|S|   Get medical help right away if you have any very serious side||
0851|147|S|effects, including: slow/shallow breathing, severe||
0851|148|S|drowsiness/difficulty waking up, fainting, seizures.||
0851|149|S|   A very serious allergic reaction to this drug is rare.||
0851|150|S|However, get medical help right away if you notice any symptoms||
0851|151|S|of a serious allergic reaction, including: rash, itching/swelling||
0851|152|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0851|153|S|breathing.||
0851|154|S|   This is not a complete list of possible side effects. If you||
0851|155|S|notice other effects not listed above, contact your doctor or||
0851|156|S|pharmacist.||
0851|157|S|   In the US -||
0851|158|S|   Call your doctor for medical advice about side effects. You||
0851|159|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0851|160|S|www.fda.gov/medwatch.||
0851|161|S|   In Canada - Call your doctor for medical advice about side||
0851|162|S|effects. You may report side effects to Health Canada at||
0851|163|S|1-866-234-2345.||
0851|164|B|||
0851|165|P|PRECAUTIONS:  Before taking hydromorphone, tell your doctor or||
0851|166|P|pharmacist if you are allergic to it; or to other opioid pain||
0851|167|P|medications (such as hydrocodone, morphine); or if you have any||
0851|168|P|other allergies. This product may contain inactive ingredients,||
0851|169|P|which can cause allergic reactions or other problems. Talk to||
0851|170|P|your pharmacist for more details.||
0851|171|P|   Before using this medication, tell your doctor or pharmacist||
0851|172|P|your medical history, especially of: kidney disease, liver||
0851|173|P|disease, lung disease (such as asthma, chronic obstructive||
0851|174|P|pulmonary disease-COPD), a certain spinal problem||
0851|175|P|(kyphoscoliosis), breathing problems (such as slow/shallow||
0851|176|P|breathing, sleep apnea), certain heart problems (irregular||
0851|177|P|heartbeat), personal or family history of a substance use||
0851|178|P|disorder (such as overuse of or addiction to drugs/alcohol),||
0851|179|P|brain disorders (such as seizures, head injury, tumor, increased||
0851|180|P|intracranial pressure), underactive thyroid (hypothyroidism),||
0851|181|P|difficulty urinating (for example, due to enlarged prostate or||
0851|182|P|narrowed urethra), disease of the pancreas (such as||
0851|183|P|pancreatitis), mental/mood disorders (such as toxic psychosis),||
0851|184|P|gallbladder disease, adrenal gland problem (such as Addison's||
0851|185|P|disease), intestinal disorders (such as colitis, blockage,||
0851|186|P|paralytic ileus, infectious diarrhea).||
0851|187|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0851|188|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0851|189|P|machinery, or do anything that needs alertness until you can do||
0851|190|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0851|191|P|are using marijuana (cannabis).||
0851|192|P|   Before having surgery, tell your doctor or dentist about all||
0851|193|P|the products you use (including prescription drugs,||
0851|194|P|nonprescription drugs, and herbal products).||
0851|195|P|   Older adults may be more sensitive to the side effects of this||
0851|196|P|drug, especially confusion, dizziness, drowsiness, and||
0851|197|P|slow/shallow breathing.||
0851|198|P|   During pregnancy, this medication should be used only when||
0851|199|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0851|200|P|benefits with your doctor. (See also Warning section.)||
0851|201|P|   This drug passes into breast milk and may have undesirable||
0851|202|P|effects on a nursing infant. Tell the doctor right away if your||
0851|203|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0851|204|P|breathing. Consult your doctor before breastfeeding.||
0851|205|B|||
0851|206|I|DRUG INTERACTIONS:  See also Warning section.||
0851|207|I|   Drug interactions may change how your medications work or||
0851|208|I|increase your risk for serious side effects. This document does||
0851|209|I|not contain all possible drug interactions. Keep a list of all||
0851|210|I|the products you use (including prescription/nonprescription||
0851|211|I|drugs and herbal products) and share it with your doctor and||
0851|212|I|pharmacist. Do not start, stop, or change the dosage of any||
0851|213|I|medicines without your doctor's approval.||
0851|214|I|   Some products that may interact with this drug include:||
0851|215|I|certain pain medications (mixed opioid agonist-antagonists such||
0851|216|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0851|217|I|samidorphan.||
0851|218|I|   The risk of serious side effects (such as slow/shallow||
0851|219|I|breathing, severe drowsiness/dizziness) may be increased if this||
0851|220|I|medication is taken with other products that may also cause||
0851|221|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0851|222|I|if you are taking other products such as other opioid pain or||
0851|223|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0851|224|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0851|225|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0851|226|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0851|227|I|cetirizine, diphenhydramine).||
0851|228|I|   Check the labels on all your medicines (such as allergy or||
0851|229|I|cough-and-cold products) because they may contain ingredients||
0851|230|I|that cause drowsiness. Ask your pharmacist about using those||
0851|231|I|products safely.||
0851|232|I|   This medication may interfere with certain lab tests (such as||
0851|233|I|amylase and lipase levels), possibly causing false test results.||
0851|234|I|Make sure lab personnel and all your doctors know you use this||
0851|235|I|drug.||
0851|236|B|||
0851|237|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0851|238|O|as passing out or trouble breathing, give them naloxone or||
0851|239|O|nalmefene if available, then call 911. If the person is awake and||
0851|240|O|has no symptoms, call a poison control center right away. US||
0851|241|O|residents can call 1-800-222-1222. Canada residents can call||
0851|242|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0851|243|O|breathing, severe drowsiness, slow heartbeat, severe dizziness,||
0851|244|O|pinpoint pupils, coma.||
0851|245|B|||
0851|246|N|NOTES:  Do not share this medication with others. Sharing it is||
0851|247|N|against the law.||
0851|248|N|   This medication has been prescribed for your current condition||
0851|249|N|only. Do not use it later for another condition unless told to do||
0851|250|N|so by your doctor. A different medication may be necessary in||
0851|251|N|that case.||
0851|252|B|||
0851|253|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0851|254|D|remember. If it is near the time of the next dose, skip the||
0851|255|D|missed dose. Take your next dose at the regular time. Do not||
0851|256|D|double the dose to catch up.||
0851|257|B|||
0851|258|R|STORAGE:  Store at room temperature away from light and moisture.||
0851|259|R|Do not store in the bathroom. Keep all medications away from||
0851|260|R|children and pets.||
0851|261|R|   Do not flush medications down the toilet or pour them into a||
0851|262|R|drain unless instructed to do so. Properly discard this product||
0851|263|R|when it is expired or no longer needed. Consult your pharmacist||
0851|264|R|or local waste disposal company.||
0851|265|B|||
0851|266|A|Information last revised August 2025.||
0851|267|A|Copyright(c) 2025 First Databank, Inc.||
0851|268|B|||
0852|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0852|002|Z|does NOT have all possible information about this product. This||
0852|003|Z|information does not assure that this product is safe, effective,||
0852|004|Z|or appropriate for you. This information is not individual||
0852|005|Z|medical advice and does not substitute for the advice of your||
0852|006|Z|health care professional. Always ask your health care||
0852|007|Z|professional for complete information about this product and your||
0852|008|Z|specific health needs.||
0852|009|B|||
0852|010|T|ERYTHROMYCIN - OPHTHALMIC||
0852|011|F|(eh-rith-row-MY-sin)||
0852|012|B|||
0852|013|C|COMMON BRAND NAME(S): Ilotycin||
0852|014|B|||
0852|015|U|USES:  This medication is used to treat certain eye infections||
0852|016|U|(such as conjunctivitis). It is also used to prevent certain eye||
0852|017|U|infections in newborns. It belongs to a class of drugs known as||
0852|018|U|macrolide antibiotics. Erythromycin works by stopping the growth||
0852|019|U|of bacteria.||
0852|020|U|   This medication treats only bacterial eye infections. It will||
0852|021|U|not work for other types of eye infections. Unnecessary use or||
0852|022|U|misuse of any antibiotic can lead to its decreased effectiveness.||
0852|023|B|||
0852|024|H|HOW TO USE:  To apply eye ointments, wash hands first. To avoid||
0852|025|H|contamination, do not touch the tube tip or let it touch your eye||
0852|026|H|or any other surface. Apply to the eyes only. Do not swallow or||
0852|027|H|inject.||
0852|028|H|   Do not wear contact lenses while you are using this||
0852|029|H|medication. Sterilize contact lenses according to the||
0852|030|H|manufacturer's directions, and check with your doctor before you||
0852|031|H|begin using them again.||
0852|032|H|   To apply eye ointments, tilt your head back, look up, and||
0852|033|H|gently pull down the lower eyelid to make a pouch. Place about a||
0852|034|H|half-inch (1 centimeter) strip of ointment into the pouch as||
0852|035|H|directed by your doctor. Gently close the eye and roll the||
0852|036|H|eyeball in all directions to spread the medication. Try not to||
0852|037|H|blink and do not rub the eye. Repeat these steps for your other||
0852|038|H|eye if so directed. Wipe the tip of the ointment tube with a||
0852|039|H|clean tissue to remove extra medication before recapping it.||
0852|040|H|   The dosage is based on your medical condition and response to||
0852|041|H|treatment. Do not increase your dose or use it more often than||
0852|042|H|directed.||
0852|043|H|   If you are using another kind of eye medication (such as drops||
0852|044|H|or ointments), wait at least 5 minutes before applying other||
0852|045|H|medications. Use eye drops before eye ointments to allow the||
0852|046|H|drops to enter the eye.||
0852|047|H|   Wait several minutes for your vision to clear before driving||
0852|048|H|or operating machinery.||
0852|049|H|   Use this medication regularly in order to get the most benefit||
0852|050|H|from it. To help you remember, use it at the same times each day.||
0852|051|H|Continue to use this medication for the full time prescribed,||
0852|052|H|even if symptoms disappear after a few days. Stopping the||
0852|053|H|medication too early may result in a return of the infection.||
0852|054|H|   Tell your doctor if your condition lasts or gets worse.||
0852|055|B|||
0852|056|S|SIDE EFFECTS:  Eye stinging/burning/redness or temporary blurred||
0852|057|S|vision may occur. If any of these effects last or get worse, tell||
0852|058|S|your doctor or pharmacist promptly.||
0852|059|S|   Remember that this medication has been prescribed because your||
0852|060|S|doctor has judged that the benefit to you is greater than the||
0852|061|S|risk of side effects. Many people using this medication do not||
0852|062|S|have serious side effects.||
0852|063|S|   Use of this medication for prolonged or repeated periods may||
0852|064|S|result in other types of eye infections, including fungal||
0852|065|S|infections. Stop using this medication and contact your doctor if||
0852|066|S|you notice new or worsening eye symptoms (such as pain, swelling,||
0852|067|S|thick discharge or pus).||
0852|068|S|   A very serious allergic reaction to this drug is rare.||
0852|069|S|However, get medical help right away if you notice any symptoms||
0852|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0852|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0852|072|S|breathing.||
0852|073|S|   This is not a complete list of possible side effects. If you||
0852|074|S|notice other effects not listed above, contact your doctor or||
0852|075|S|pharmacist.||
0852|076|S|   In the US -||
0852|077|S|   Call your doctor for medical advice about side effects. You||
0852|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0852|079|S|www.fda.gov/medwatch.||
0852|080|S|   In Canada - Call your doctor for medical advice about side||
0852|081|S|effects. You may report side effects to Health Canada at||
0852|082|S|1-866-234-2345.||
0852|083|B|||
0852|084|P|PRECAUTIONS:  Before using erythromycin, tell your doctor or||
0852|085|P|pharmacist if you are allergic to it; or to other macrolide||
0852|086|P|antibiotics (such as clarithromycin); or if you have any other||
0852|087|P|allergies. This product may contain inactive ingredients, which||
0852|088|P|can cause allergic reactions or other problems. Talk to your||
0852|089|P|pharmacist for more details.||
0852|090|P|   Before using this medication, tell your doctor or pharmacist||
0852|091|P|your medical history.||
0852|092|P|   After you apply this drug, your vision may become temporarily||
0852|093|P|blurred. Do not drive, use machinery, or do anything that needs||
0852|094|P|clear vision until you can do it safely.||
0852|095|P|   Before having surgery, tell your doctor or dentist about all||
0852|096|P|the products you use (including prescription drugs,||
0852|097|P|nonprescription drugs, and herbal products).||
0852|098|P|   During pregnancy, this medication should be used only when||
0852|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
0852|100|P|   It is unknown if erythromycin passes into breast milk when||
0852|101|P|given as an eye ointment. It is unlikely to harm a nursing||
0852|102|P|infant. Consult your doctor before breastfeeding.||
0852|103|B|||
0852|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0852|105|I|medications work or increase your risk for serious side effects.||
0852|106|I|This document does not contain all possible drug interactions.||
0852|107|I|Keep a list of all the products you use (including||
0852|108|I|prescription/nonprescription drugs and herbal products) and share||
0852|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
0852|110|I|the dosage of any medicines without your doctor's approval.||
0852|111|B|||
0852|112|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0852|113|O|has overdosed and has serious symptoms such as passing out or||
0852|114|O|trouble breathing, call 911. Otherwise, call a poison control||
0852|115|O|center right away. US residents can call 1-800-222-1222. Canada||
0852|116|O|residents can call 1-844-764-7669.||
0852|117|B|||
0852|118|N|NOTES:  Do not share this medication with others.||
0852|119|N|   This medication has been prescribed for your current condition||
0852|120|N|only. Do not use it later for another infection unless your||
0852|121|N|doctor tells you to.||
0852|122|B|||
0852|123|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0852|124|D|If it is near the time of the next dose, skip the missed dose.||
0852|125|D|Use your next dose at the regular time. Do not double the dose to||
0852|126|D|catch up.||
0852|127|B|||
0852|128|R|STORAGE:  Store at room temperature. Do not expose this drug to||
0852|129|R|high heat. Do not freeze. Keep all medications away from children||
0852|130|R|and pets.||
0852|131|R|   Do not flush medications down the toilet or pour them into a||
0852|132|R|drain unless instructed to do so. Properly discard this product||
0852|133|R|when it is expired or no longer needed. Consult your pharmacist||
0852|134|R|or local waste disposal company.||
0852|135|B|||
0852|136|A|Information last revised May 2024.||
0852|137|A|Copyright(c) 2025 First Databank, Inc.||
0852|138|B|||
0853|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0853|002|Z|does NOT have all possible information about this product. This||
0853|003|Z|information does not assure that this product is safe, effective,||
0853|004|Z|or appropriate for you. This information is not individual||
0853|005|Z|medical advice and does not substitute for the advice of your||
0853|006|Z|health care professional. Always ask your health care||
0853|007|Z|professional for complete information about this product and your||
0853|008|Z|specific health needs.||
0853|009|B|||
0853|010|T|HYDROMORPHONE SUPPOSITORY - RECTAL||
0853|011|F|(hye-droe-MOR-fone)||
0853|012|B|||
0853|013|C|COMMON BRAND NAME(S): Dilaudid||
0853|014|B|||
0853|015|W|WARNING:  Hydromorphone has a risk for abuse and addiction, which||
0853|016|W|can lead to overdose and death. Hydromorphone may also cause||
0853|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
0853|018|W|your doctor should have you use the smallest dose of||
0853|019|W|hydromorphone that works, and use it for the shortest possible||
0853|020|W|time. See also How to Use section for more information about||
0853|021|W|addiction.||
0853|022|W|   Ask your doctor or pharmacist if you should have medication||
0853|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0853|024|W|Teach your family or household members about the signs of an||
0853|025|W|opioid overdose and how to treat it.||
0853|026|W|   The risk for severe breathing problems is higher when you||
0853|027|W|start this medication and after a dose increase, or if you use||
0853|028|W|the wrong dose/strength. Using this medication with alcohol or||
0853|029|W|other drugs that can cause drowsiness or breathing problems may||
0853|030|W|cause very serious side effects, including death. Be sure you||
0853|031|W|know how to use hydromorphone and what other drugs you should||
0853|032|W|avoid using with it. See also Drug Interactions section. Get||
0853|033|W|medical help right away if any of these very serious side effects||
0853|034|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
0853|035|W|drowsiness/dizziness, difficulty waking up.||
0853|036|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0853|037|W|or abuse. If someone accidentally swallows this drug, get medical||
0853|038|W|help right away.||
0853|039|W|   Before using this medication, women of childbearing age should||
0853|040|W|talk with their doctor(s) about the risks and benefits. Tell your||
0853|041|W|doctor if you are pregnant or if you plan to become pregnant.||
0853|042|W|During pregnancy, this medication should be used only when||
0853|043|W|clearly needed. It may slightly increase the risk of birth||
0853|044|W|defects if used during the first two months of pregnancy. Also,||
0853|045|W|using it for a long time or in high doses near the expected||
0853|046|W|delivery date may harm the unborn baby. To lessen the risk, use||
0853|047|W|the smallest effective dose for the shortest possible time.||
0853|048|W|Babies born to mothers who use this drug for a long time may||
0853|049|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0853|050|W|doctor right away if you notice any symptoms in your newborn baby||
0853|051|W|such as crying that doesn't stop, slow/shallow breathing,||
0853|052|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0853|053|W|difficulty gaining weight.||
0853|054|B|||
0853|055|U|USES:  Hydromorphone is used to treat moderate to severe pain. It||
0853|056|U|acts on certain centers in the brain to give you pain relief.||
0853|057|U|This medication is an opioid pain reliever.||
0853|058|B|||
0853|059|H|HOW TO USE:  Wash your hands before and after using the||
0853|060|H|suppository. Unwrap and insert one suppository into the rectum as||
0853|061|H|directed by your doctor. Lie down on your left side with right||
0853|062|H|knee bent. Gently push the suppository into the rectum with your||
0853|063|H|finger. Remain lying down for a few minutes, and avoid having a||
0853|064|H|bowel movement for an hour or longer so the drug will be||
0853|065|H|absorbed. The suppository is for use in the rectum only.||
0853|066|H|   If you have nausea, ask your doctor or pharmacist about ways||
0853|067|H|to decrease nausea (such as lying down for 1 to 2 hours with as||
0853|068|H|little head movement as possible).||
0853|069|H|   The dosage is based on your medical condition and response to||
0853|070|H|treatment. Do not increase your dose, use the medication more||
0853|071|H|often, or use it for a longer time than prescribed. Properly stop||
0853|072|H|the medication when so directed.||
0853|073|H|   Pain medications work best if they are used when the first||
0853|074|H|signs of pain occur. If you wait until the pain has worsened, the||
0853|075|H|medication may not work as well.||
0853|076|H|   Suddenly stopping this medication may cause withdrawal,||
0853|077|H|especially if you have used it for a long time or in high doses.||
0853|078|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0853|079|H|Tell your doctor or pharmacist right away if you have any||
0853|080|H|withdrawal symptoms such as restlessness, mental/mood changes||
0853|081|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0853|082|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0853|083|H|aches, or sudden changes in behavior.||
0853|084|H|   When this medication is used for a long time, it may not work||
0853|085|H|as well. Talk with your doctor if this medication stops working||
0853|086|H|well.||
0853|087|H|   Though it helps many people, this medication may sometimes||
0853|088|H|cause addiction. This risk may be higher if you have a||
0853|089|H|mental/mood disorder or a substance use disorder (such as overuse||
0853|090|H|of or addiction to drugs/alcohol). Use this medication exactly as||
0853|091|H|prescribed to lower the risk of addiction. Ask your doctor or||
0853|092|H|pharmacist for more details.||
0853|093|H|   Tell your doctor if your pain does not get better or if it||
0853|094|H|gets worse, or if you have any new pain.||
0853|095|B|||
0853|096|S|SIDE EFFECTS:  See also Warning section.||
0853|097|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0853|098|S|drowsiness, increased sweating, or dry mouth may occur. If any of||
0853|099|S|these effects last or get worse, tell your doctor or pharmacist||
0853|100|S|promptly.||
0853|101|S|   To prevent constipation, eat dietary fiber, drink enough||
0853|102|S|water, and exercise. You may also need to take a laxative. Ask||
0853|103|S|your pharmacist which type of laxative is right for you.||
0853|104|S|   To reduce the risk of dizziness and lightheadedness, get up||
0853|105|S|slowly when rising from a sitting or lying position.||
0853|106|S|   Remember that this medication has been prescribed because your||
0853|107|S|doctor has judged that the benefit to you is greater than the||
0853|108|S|risk of side effects. Many people using this medication do not||
0853|109|S|have serious side effects.||
0853|110|S|   Tell your doctor right away if you have any serious side||
0853|111|S|effects, including: interrupted breathing during sleep (sleep||
0853|112|S|apnea), mental/mood changes (such as agitation, hallucinations,||
0853|113|S|confusion), difficulty urinating, vision changes, slow/fast||
0853|114|S|heartbeat, severe stomach/abdominal pain, signs of your adrenal||
0853|115|S|glands not working well (such as loss of appetite, unusual||
0853|116|S|tiredness, weight loss), trouble swallowing.||
0853|117|S|   Get medical help right away if you have any very serious side||
0853|118|S|effects, including: slow/shallow breathing, fainting, seizures,||
0853|119|S|severe drowsiness/difficulty waking up.||
0853|120|S|   A very serious allergic reaction to this drug is rare.||
0853|121|S|However, get medical help right away if you notice any symptoms||
0853|122|S|of a serious allergic reaction, including: rash, itching/swelling||
0853|123|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0853|124|S|breathing.||
0853|125|S|   This is not a complete list of possible side effects. If you||
0853|126|S|notice other effects not listed above, contact your doctor or||
0853|127|S|pharmacist.||
0853|128|S|   In the US -||
0853|129|S|   Call your doctor for medical advice about side effects. You||
0853|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0853|131|S|www.fda.gov/medwatch.||
0853|132|S|   In Canada - Call your doctor for medical advice about side||
0853|133|S|effects. You may report side effects to Health Canada at||
0853|134|S|1-866-234-2345.||
0853|135|B|||
0853|136|P|PRECAUTIONS:  Before using hydromorphone, tell your doctor or||
0853|137|P|pharmacist if you are allergic to it; or to other opioid pain||
0853|138|P|medications (such as hydrocodone, morphine); or if you have any||
0853|139|P|other allergies. This product may contain inactive ingredients,||
0853|140|P|which can cause allergic reactions or other problems. Talk to||
0853|141|P|your pharmacist for more details.||
0853|142|P|   Before using this medication, tell your doctor or pharmacist||
0853|143|P|your medical history, especially of: kidney disease, liver||
0853|144|P|disease, lung disease (such as asthma, chronic obstructive||
0853|145|P|pulmonary disease-COPD), a certain spinal problem||
0853|146|P|(kyphoscoliosis), breathing problems (such as slow/shallow||
0853|147|P|breathing, sleep apnea), certain heart problems (irregular||
0853|148|P|heartbeat), personal or family history of a substance use||
0853|149|P|disorder (such as overuse of or addiction to drugs/alcohol),||
0853|150|P|brain disorders (such as seizures, head injury, tumor, increased||
0853|151|P|intracranial pressure), underactive thyroid (hypothyroidism),||
0853|152|P|difficulty urinating (for example, due to enlarged prostate or||
0853|153|P|narrowed urethra), disease of the pancreas (such as||
0853|154|P|pancreatitis), mental/mood disorders (such as toxic psychosis),||
0853|155|P|gallbladder disease, adrenal gland problem (such as Addison's||
0853|156|P|disease), intestinal disorders (such as colitis, blockage,||
0853|157|P|paralytic ileus, infectious diarrhea).||
0853|158|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0853|159|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0853|160|P|machinery, or do anything that needs alertness until you can do||
0853|161|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0853|162|P|are using marijuana (cannabis).||
0853|163|P|   Before having surgery, tell your doctor or dentist about all||
0853|164|P|the products you use (including prescription drugs,||
0853|165|P|nonprescription drugs, and herbal products).||
0853|166|P|   Older adults may be more sensitive to the side effects of this||
0853|167|P|drug, especially confusion, dizziness, drowsiness, and||
0853|168|P|slow/shallow breathing.||
0853|169|P|   During pregnancy, this medication should be used only when||
0853|170|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0853|171|P|benefits with your doctor. (See also Warning section.)||
0853|172|P|   This drug passes into breast milk. Consult your doctor before||
0853|173|P|breastfeeding.||
0853|174|B|||
0853|175|I|DRUG INTERACTIONS:  See also Warning section.||
0853|176|I|   Drug interactions may change how your medications work or||
0853|177|I|increase your risk for serious side effects. This document does||
0853|178|I|not contain all possible drug interactions. Keep a list of all||
0853|179|I|the products you use (including prescription/nonprescription||
0853|180|I|drugs and herbal products) and share it with your doctor and||
0853|181|I|pharmacist. Do not start, stop, or change the dosage of any||
0853|182|I|medicines without your doctor's approval.||
0853|183|I|   Some products that may interact with this drug include:||
0853|184|I|certain pain medications (mixed opioid agonist-antagonists such||
0853|185|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0853|186|I|samidorphan.||
0853|187|I|   The risk of serious side effects (such as slow/shallow||
0853|188|I|breathing, severe drowsiness/dizziness) may be increased if this||
0853|189|I|medication is used with other products that may also cause||
0853|190|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0853|191|I|if you are using other products such as other opioid pain or||
0853|192|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0853|193|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0853|194|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0853|195|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0853|196|I|cetirizine, diphenhydramine).||
0853|197|I|   Check the labels on all your medicines (such as allergy or||
0853|198|I|cough-and-cold products) because they may contain ingredients||
0853|199|I|that cause drowsiness. Ask your pharmacist about using those||
0853|200|I|products safely.||
0853|201|I|   This medication may interfere with certain lab tests (such as||
0853|202|I|amylase and lipase levels), possibly causing false test results.||
0853|203|I|Make sure lab personnel and all your doctors know you use this||
0853|204|I|drug.||
0853|205|B|||
0853|206|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0853|207|O|as passing out or trouble breathing, give them naloxone or||
0853|208|O|nalmefene if available, then call 911. If the person is awake and||
0853|209|O|has no symptoms, call a poison control center right away. US||
0853|210|O|residents can call 1-800-222-1222. Canada residents can call||
0853|211|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0853|212|O|breathing, severe drowsiness, slow heartbeat, severe dizziness,||
0853|213|O|pinpoint pupils, coma.||
0853|214|B|||
0853|215|N|NOTES:  Do not share this medication with others. Sharing it is||
0853|216|N|against the law.||
0853|217|N|   This medication has been prescribed for your current condition||
0853|218|N|only. Do not use it later for another condition unless told to do||
0853|219|N|so by your doctor. A different medication may be necessary in||
0853|220|N|that case.||
0853|221|B|||
0853|222|D|MISSED DOSE:  If you use this medication regularly and miss a||
0853|223|D|dose, use it as soon as you remember. If it is near the time of||
0853|224|D|the next dose, skip the missed dose. Use your next dose at the||
0853|225|D|regular time. Do not double the dose to catch up.||
0853|226|B|||
0853|227|R|STORAGE:  Store in the refrigerator away from light. Keep all||
0853|228|R|medications away from children and pets.||
0853|229|R|   Do not flush medications down the toilet or pour them into a||
0853|230|R|drain unless instructed to do so. Properly discard this product||
0853|231|R|when it is expired or no longer needed. Consult your pharmacist||
0853|232|R|or local waste disposal company.||
0853|233|B|||
0853|234|A|Information last revised August 2025.||
0853|235|A|Copyright(c) 2025 First Databank, Inc.||
0853|236|B|||
0854|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0854|002|Z|does NOT have all possible information about this product. This||
0854|003|Z|information does not assure that this product is safe, effective,||
0854|004|Z|or appropriate for you. This information is not individual||
0854|005|Z|medical advice and does not substitute for the advice of your||
0854|006|Z|health care professional. Always ask your health care||
0854|007|Z|professional for complete information about this product and your||
0854|008|Z|specific health needs.||
0854|009|B|||
0854|010|T|HYDROXYZINE - INJECTION||
0854|011|F|(hye-DROX-i-zeen)||
0854|012|B|||
0854|013|C|COMMON BRAND NAME(S): Vistaril||
0854|014|B|||
0854|015|U|USES:  Hydroxyzine is used for the short-term treatment of||
0854|016|U|nervousness and tension that may occur with certain mental/mood||
0854|017|U|disorders (such as anxiety, dementia). It is also used to help||
0854|018|U|manage withdrawal symptoms (such as anxiety, agitation) in||
0854|019|U|alcoholics. Other uses include helping to decrease anxiety and||
0854|020|U|nausea before/after surgery or during childbirth or helping||
0854|021|U|certain opioid pain relievers (such as meperidine) work better.||
0854|022|U|   Hydroxyzine belongs to a class of medications called||
0854|023|U|antihistamines. It is thought to work by affecting certain||
0854|024|U|natural substances (acetylcholine, serotonin) in your body or by||
0854|025|U|acting directly on certain parts of the brain. Hydroxyzine also||
0854|026|U|blocks a natural substance that your body makes during an||
0854|027|U|allergic reaction (histamine).||
0854|028|B|||
0854|029|H|HOW TO USE:  This medication is given by injection into a muscle||
0854|030|H|as directed by your doctor. The dosage is based on your age,||
0854|031|H|weight, medical condition, and response to treatment.||
0854|032|H|   If you are giving this medication to yourself at home, learn||
0854|033|H|all preparation and usage instructions from your health care||
0854|034|H|professional. Before using, check this product for particles or||
0854|035|H|discoloration. If either is present, do not use the liquid. Learn||
0854|036|H|how to store and discard medical supplies safely.||
0854|037|B|||
0854|038|S|SIDE EFFECTS:  Drowsiness, dizziness, blurred vision, dry mouth,||
0854|039|S|constipation, or headache may occur. If any of these effects last||
0854|040|S|or get worse, tell your doctor or pharmacist promptly.||
0854|041|S|   To relieve dry mouth, suck on sugarless hard candy or ice||
0854|042|S|chips, chew sugarless gum, drink water, or use a saliva||
0854|043|S|substitute.||
0854|044|S|   To reduce the risk of dizziness and lightheadedness, get up||
0854|045|S|slowly when rising from a sitting or lying position.||
0854|046|S|   Remember that this medication has been prescribed because your||
0854|047|S|doctor has judged that the benefit to you is greater than the||
0854|048|S|risk of side effects. Many people using this medication do not||
0854|049|S|have serious side effects.||
0854|050|S|   Tell your doctor right away if you have any serious side||
0854|051|S|effects, including: mental/mood changes (such as worsening||
0854|052|S|anxiety, confusion, hallucinations), shaking (tremor), trouble||
0854|053|S|urinating, vision changes.||
0854|054|S|   Get medical help right away if you have any very serious side||
0854|055|S|effects, including: seizures, fast/irregular heartbeat, severe||
0854|056|S|dizziness, fainting.||
0854|057|S|   A very serious allergic reaction to this drug is rare.||
0854|058|S|However, get medical help right away if you notice any symptoms||
0854|059|S|of a serious allergic reaction, including: rash, itching/swelling||
0854|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0854|061|S|breathing.||
0854|062|S|   This is not a complete list of possible side effects. If you||
0854|063|S|notice other effects not listed above, contact your doctor or||
0854|064|S|pharmacist.||
0854|065|S|   In the US -||
0854|066|S|   Call your doctor for medical advice about side effects. You||
0854|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0854|068|S|www.fda.gov/medwatch.||
0854|069|S|   In Canada - Call your doctor for medical advice about side||
0854|070|S|effects. You may report side effects to Health Canada at||
0854|071|S|1-866-234-2345.||
0854|072|B|||
0854|073|P|PRECAUTIONS:  Before using hydroxyzine, tell your doctor or||
0854|074|P|pharmacist if you are allergic to it; or to cetirizine; or to||
0854|075|P|levocetirizine; or if you have any other allergies. This product||
0854|076|P|may contain inactive ingredients, which can cause allergic||
0854|077|P|reactions or other problems. Talk to your pharmacist for more||
0854|078|P|details.||
0854|079|P|   Before using this medication, tell your doctor or pharmacist||
0854|080|P|your medical history, especially of: breathing problems (such as||
0854|081|P|asthma, emphysema), a certain eye problem (glaucoma), high blood||
0854|082|P|pressure, kidney disease, liver disease, seizures,||
0854|083|P|stomach/intestine problems (such as ulcer, blockage), overactive||
0854|084|P|thyroid (hyperthyroidism), urination problems (such as due to||
0854|085|P|enlarged prostate, urinary retention).||
0854|086|P|   Hydroxyzine may cause a condition that affects the heart||
0854|087|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0854|088|P|serious (rarely fatal) fast/irregular heartbeat and other||
0854|089|P|symptoms (such as severe dizziness, fainting) that need medical||
0854|090|P|attention right away.||
0854|091|P|   The risk of QT prolongation may be increased if you have||
0854|092|P|certain medical conditions or are taking other drugs that may||
0854|093|P|cause QT prolongation. Before using hydroxyzine, tell your doctor||
0854|094|P|or pharmacist of all the drugs you take and if you have any of||
0854|095|P|the following conditions: certain heart problems (heart failure,||
0854|096|P|slow heartbeat, QT prolongation in the EKG), family history of||
0854|097|P|certain heart problems (QT prolongation in the EKG, sudden||
0854|098|P|cardiac death).||
0854|099|P|   Low levels of potassium or magnesium in the blood may also||
0854|100|P|increase your risk of QT prolongation. This risk may increase if||
0854|101|P|you use certain drugs (such as diuretics/"water pills") or if you||
0854|102|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0854|103|P|Talk to your doctor about using hydroxyzine safely.||
0854|104|P|   This drug may make you dizzy or drowsy or blur your vision.||
0854|105|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0854|106|P|drowsy. Do not drive, use machinery, or do anything that needs||
0854|107|P|alertness or clear vision until you can do it safely. Limit||
0854|108|P|alcoholic beverages. Talk to your doctor if you are using||
0854|109|P|marijuana (cannabis).||
0854|110|P|   Before having surgery, tell your doctor or dentist about all||
0854|111|P|the products you use (including prescription drugs,||
0854|112|P|nonprescription drugs, and herbal products).||
0854|113|P|   Older adults may be more sensitive to the side effects of this||
0854|114|P|drug, especially drowsiness, confusion, constipation, trouble||
0854|115|P|urinating or QT prolongation (see above). Drowsiness and||
0854|116|P|confusion can increase the risk of falling.||
0854|117|P|   Children may be more sensitive to the side effects of this||
0854|118|P|drug. This drug can often cause excitement in young children||
0854|119|P|instead of drowsiness.||
0854|120|P|   During pregnancy, this medication should be used only when||
0854|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
0854|122|P|   It is unknown if this drug passes into breast milk. Consult||
0854|123|P|your doctor before breastfeeding.||
0854|124|B|||
0854|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0854|126|I|medications work or increase your risk for serious side effects.||
0854|127|I|This document does not contain all possible drug interactions.||
0854|128|I|Keep a list of all the products you use (including||
0854|129|I|prescription/nonprescription drugs and herbal products) and share||
0854|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
0854|131|I|the dosage of any medicines without your doctor's approval.||
0854|132|I|   Tell your doctor or pharmacist if you are taking other||
0854|133|I|products that cause drowsiness such as opioid pain or cough||
0854|134|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0854|135|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0854|136|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0854|137|I|cyclobenzaprine), or other antihistamines (such as||
0854|138|I|diphenhydramine, promethazine).||
0854|139|I|   Check the labels on all your medicines (such as allergy or||
0854|140|I|cough-and-cold products) because they may contain ingredients||
0854|141|I|that cause drowsiness. Ask your pharmacist about using those||
0854|142|I|products safely.||
0854|143|I|   This medication may interfere with certain lab tests (such as||
0854|144|I|allergy skin tests, urine corticosteroids), possibly causing||
0854|145|I|false test results. Make sure lab personnel and all your doctors||
0854|146|I|know you use this drug.||
0854|147|B|||
0854|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0854|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0854|150|O|poison control center right away. US residents can call||
0854|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0854|152|O|Symptoms of overdose may include: severe dizziness/drowsiness.||
0854|153|B|||
0854|154|N|NOTES:  Do not share this medication with others.||
0854|155|B|||
0854|156|D|MISSED DOSE:  It is important to get each dose of this medication||
0854|157|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0854|158|D|right away for a new dosing schedule. Do not double the dose to||
0854|159|D|catch up.||
0854|160|B|||
0854|161|R|STORAGE:  Store at room temperature away from light. Keep all||
0854|162|R|medications away from children and pets.||
0854|163|R|   Do not flush medications down the toilet or pour them into a||
0854|164|R|drain unless instructed to do so. Properly discard this product||
0854|165|R|when it is expired or no longer needed. Consult your pharmacist||
0854|166|R|or local waste disposal company.||
0854|167|B|||
0854|168|A|Information last revised November 2024.||
0854|169|A|Copyright(c) 2025 First Databank, Inc.||
0854|170|B|||
0855|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0855|002|Z|does NOT have all possible information about this product. This||
0855|003|Z|information does not assure that this product is safe, effective,||
0855|004|Z|or appropriate for you. This information is not individual||
0855|005|Z|medical advice and does not substitute for the advice of your||
0855|006|Z|health care professional. Always ask your health care||
0855|007|Z|professional for complete information about this product and your||
0855|008|Z|specific health needs.||
0855|009|B|||
0855|010|T|PARICALCITOL - ORAL||
0855|011|F|(pear-ih-KAL-sit-ole)||
0855|012|B|||
0855|013|C|COMMON BRAND NAME(S): Zemplar||
0855|014|B|||
0855|015|U|USES:  Paricalcitol is used to treat and prevent high levels of a||
0855|016|U|certain natural substance made by the body (parathyroid hormone)||
0855|017|U|in patients with long-term kidney disease. In these patients, the||
0855|018|U|high level of parathyroid hormone is caused by a low level of||
0855|019|U|calcium and a certain kind of vitamin D. Too much parathyroid||
0855|020|U|hormone can cause serious problems such as bone disorders.||
0855|021|U|Paricalcitol is a man-made form of vitamin D. It helps to reduce||
0855|022|U|parathyroid hormone levels and may help your body absorb calcium||
0855|023|U|and phosphorus.||
0855|024|B|||
0855|025|H|HOW TO USE:  Take this medication by mouth with or without food||
0855|026|H|as directed by your doctor, usually once daily or 3 times a week.||
0855|027|H|If you are taking this medication 3 times a week, do not take it||
0855|028|H|more often than every other day.||
0855|029|H|   The dosage is based on your medical condition, lab tests, and||
0855|030|H|response to treatment.||
0855|031|H|   Use this medication regularly to get the most benefit from it.||
0855|032|H|To help you remember, take it at the same time each day. If you||
0855|033|H|are taking this medication on a schedule other than every day||
0855|034|H|(such as 3 times a week), it may help to mark your calendar with||
0855|035|H|a reminder.||
0855|036|H|   It is very important to follow the diet recommended by your||
0855|037|H|doctor to get the most benefit from this medication and to||
0855|038|H|prevent serious side effects. Do not take other||
0855|039|H|supplements/vitamins (such as calcium, vitamin D) unless ordered||
0855|040|H|by your doctor.||
0855|041|B|||
0855|042|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0855|043|S|because your doctor has judged that the benefit to you is greater||
0855|044|S|than the risk of side effects. Many people using this medication||
0855|045|S|do not have serious side effects.||
0855|046|S|   Tell your doctor right away if you have any serious side||
0855|047|S|effects, including: fast/slow/irregular heartbeat, seizures,||
0855|048|S|weakness, loss of appetite, back/bone/joint/muscle pain,||
0855|049|S|constipation, dry mouth, eye pain/redness/sensitivity to light,||
0855|050|S|headache, nausea/vomiting, drowsiness, stomach/abdominal pain,||
0855|051|S|increased thirst, signs of kidney problems (such as change in the||
0855|052|S|amount of urine), mental/mood changes (such as psychosis).||
0855|053|S|   A very serious allergic reaction to this drug is rare.||
0855|054|S|However, get medical help right away if you notice any symptoms||
0855|055|S|of a serious allergic reaction, including: rash, itching/swelling||
0855|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0855|057|S|breathing.||
0855|058|S|   This is not a complete list of possible side effects. If you||
0855|059|S|notice other effects not listed above, contact your doctor or||
0855|060|S|pharmacist.||
0855|061|S|   In the US -||
0855|062|S|   Call your doctor for medical advice about side effects. You||
0855|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0855|064|S|www.fda.gov/medwatch.||
0855|065|S|   In Canada - Call your doctor for medical advice about side||
0855|066|S|effects. You may report side effects to Health Canada at||
0855|067|S|1-866-234-2345.||
0855|068|B|||
0855|069|P|PRECAUTIONS:  Before taking paricalcitol, tell your doctor or||
0855|070|P|pharmacist if you are allergic to it; or to other vitamin D||
0855|071|P|products; or if you have any other allergies. This product may||
0855|072|P|contain inactive ingredients, which can cause allergic reactions||
0855|073|P|or other problems. Talk to your pharmacist for more details.||
0855|074|P|   Before using this medication, tell your doctor or pharmacist||
0855|075|P|your medical history, especially of: high levels of calcium||
0855|076|P|(hypercalcemia), high levels of vitamin D (hypervitaminosis D),||
0855|077|P|heart disease (such as irregular heartbeat, coronary artery||
0855|078|P|disease), seizures.||
0855|079|P|   Before having surgery, tell your doctor or dentist about all||
0855|080|P|the products you use (including prescription drugs,||
0855|081|P|nonprescription drugs, and herbal products).||
0855|082|P|   During pregnancy, this medication should be used only when||
0855|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
0855|084|P|   It is unknown if this medication passes into breast milk.||
0855|085|P|Consult your doctor before breastfeeding.||
0855|086|B|||
0855|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0855|088|I|medications work or increase your risk for serious side effects.||
0855|089|I|This document does not contain all possible drug interactions.||
0855|090|I|Keep a list of all the products you use (including||
0855|091|I|prescription/nonprescription drugs and herbal products) and share||
0855|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
0855|093|I|the dosage of any medicines without your doctor's approval.||
0855|094|I|   Some products that may interact with this drug include:||
0855|095|I|burosumab, other vitamin D products (such as ergocalciferol),||
0855|096|I|products that contain aluminum (such as certain antacids,||
0855|097|I|phosphate binders), corticosteroids (such as prednisone).||
0855|098|I|   Check the labels on all your prescription and||
0855|099|I|nonprescription/herbal products (such as antacids, vitamins)||
0855|100|I|because they may contain aluminum, calcium, phosphate, or vitamin||
0855|101|I|D. Ask your pharmacist about using those products safely.||
0855|102|I|   Certain medications can decrease the absorption of vitamin D||
0855|103|I|(bile acid sequestrants such as cholestyramine/colestipol,||
0855|104|I|mineral oil, orlistat). Separate your doses of these medications||
0855|105|I|as far as possible from your doses of vitamin D. It may be||
0855|106|I|easiest to take vitamin D at bedtime if you are also taking these||
0855|107|I|other medications. Ask your doctor or pharmacist about how long||
0855|108|I|you should wait between doses and for help finding a dosing||
0855|109|I|schedule that will work with all your medications.||
0855|110|I|   This medication may interfere with certain lab tests (such as||
0855|111|I|cholesterol tests), possibly causing false test results. Make||
0855|112|I|sure lab personnel and all your doctors know you use this drug.||
0855|113|B|||
0855|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0855|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0855|116|O|poison control center right away. US residents can call||
0855|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0855|118|O|Symptoms of overdose may include: weakness, headache, loss of||
0855|119|O|appetite, nausea, vomiting, stomach cramps, drowsiness.||
0855|120|B|||
0855|121|N|NOTES:  Do not share this medication with others.||
0855|122|N|   Lab and/or medical tests (such as calcium, phosphorus,||
0855|123|N|parathyroid hormone levels) should be done while you are taking||
0855|124|N|this medication. Keep all medical and lab appointments. Consult||
0855|125|N|your doctor for more details.||
0855|126|B|||
0855|127|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0855|128|D|remember. If it is near the time of the next dose, skip the||
0855|129|D|missed dose. Take your next dose at the regular time. Do not||
0855|130|D|double the dose to catch up.||
0855|131|B|||
0855|132|R|STORAGE:  Store at room temperature away from light and moisture.||
0855|133|R|Do not store in the bathroom. Keep all medications away from||
0855|134|R|children and pets.||
0855|135|R|   Do not flush medications down the toilet or pour them into a||
0855|136|R|drain unless instructed to do so. Properly discard this product||
0855|137|R|when it is expired or no longer needed. Consult your pharmacist||
0855|138|R|or local waste disposal company.||
0855|139|B|||
0855|140|A|Information last revised October 2024.||
0855|141|A|Copyright(c) 2025 First Databank, Inc.||
0855|142|B|||
0859|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0859|002|Z|does NOT have all possible information about this product. This||
0859|003|Z|information does not assure that this product is safe, effective,||
0859|004|Z|or appropriate for you. This information is not individual||
0859|005|Z|medical advice and does not substitute for the advice of your||
0859|006|Z|health care professional. Always ask your health care||
0859|007|Z|professional for complete information about this product and your||
0859|008|Z|specific health needs.||
0859|009|B|||
0859|010|T|HYDROCORTISONE - TOPICAL||
0859|011|F|(HYE-droe-KOR-ti-sone)||
0859|012|B|||
0859|013|C|COMMON BRAND NAME(S): Aquanil HC, Cetacort, Cortaid, Hytone||
0859|014|B|||
0859|015|U|USES:  This medication is used to treat a variety of skin||
0859|016|U|conditions (such as insect bites, poison oak/ivy, eczema,||
0859|017|U|dermatitis, allergies, rash, itching of the outer female||
0859|018|U|genitals, anal itching). Hydrocortisone reduces the swelling,||
0859|019|U|itching, and redness that can occur in these types of conditions.||
0859|020|U|This medication is a mild corticosteroid.||
0859|021|B|||
0859|022|H|HOW TO USE:  There are many hydrocortisone products available.||
0859|023|H|Many can be purchased without a prescription. Some products||
0859|024|H|require a prescription. Consult your doctor or pharmacist on the||
0859|025|H|choice of the product that is best for you.||
0859|026|H|   Use this medication on the skin only. However, do not use it||
0859|027|H|on the face or underarms unless directed to do so by your doctor.||
0859|028|H|Some products are meant to be used on the scalp for various||
0859|029|H|conditions. To correctly use these products, follow the||
0859|030|H|directions on the product package.||
0859|031|H|   Wash and dry your hands before using. Clean and dry the||
0859|032|H|affected area. If you are using the lotion or foam, shake it well||
0859|033|H|just before using. If you are using the spray, check the product||
0859|034|H|package to see if it needs to be shaken before each use. Apply a||
0859|035|H|small amount of medication to the affected area and gently rub||
0859|036|H|in, usually up to 4 times a day or as directed by your doctor or||
0859|037|H|the product package. The dosage and length of treatment depends||
0859|038|H|on the type of condition being treated. Do not bandage, cover, or||
0859|039|H|wrap the area unless directed to do so by your doctor. If used in||
0859|040|H|or near the diaper area on an infant, do not use tight-fitting||
0859|041|H|diapers or plastic pants.||
0859|042|H|   After applying the medication, wash your hands, unless the||
0859|043|H|hands are being treated. Avoid getting this medication in the||
0859|044|H|eyes, nose, or mouth. If you get the medication in these areas,||
0859|045|H|rinse with plenty of water. If irritation occurs or continues,||
0859|046|H|contact your doctor right away.||
0859|047|H|   Use this medication only for the condition for which it was||
0859|048|H|prescribed or a condition that is listed on the product package.||
0859|049|H|Do not use it for longer than directed by the product package or||
0859|050|H|your doctor.||
0859|051|H|   Tell your doctor if your condition lasts or gets worse after 7||
0859|052|H|days. If you think you may have a serious medical problem, get||
0859|053|H|medical help right away.||
0859|054|B|||
0859|055|S|SIDE EFFECTS:  Stinging, burning, irritation, dryness, or redness||
0859|056|S|at the application site may occur. Acne, unusual hair growth,||
0859|057|S|small red bumps on the skin (folliculitis), skin||
0859|058|S|thinning/discoloration, or stretch marks may also occur. If any||
0859|059|S|of these effects last or get worse, tell your doctor or||
0859|060|S|pharmacist promptly.||
0859|061|S|   If your doctor has directed you to use this medication,||
0859|062|S|remember that your doctor has judged that the benefit to you is||
0859|063|S|greater than the risk of side effects. Many people using this||
0859|064|S|medication do not have serious side effects.||
0859|065|S|   If the treated area starts to bleed, especially if you are||
0859|066|S|using this product for anal itching, contact your doctor right||
0859|067|S|away.||
0859|068|S|   A very serious allergic reaction to this drug is rare.||
0859|069|S|However, get medical help right away if you notice any symptoms||
0859|070|S|of a serious allergic reaction, including: rash, itching/swelling||
0859|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0859|072|S|breathing.||
0859|073|S|   This is not a complete list of possible side effects. If you||
0859|074|S|notice other effects not listed above, contact your doctor or||
0859|075|S|pharmacist.||
0859|076|S|   In the US -||
0859|077|S|   Call your doctor for medical advice about side effects. You||
0859|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0859|079|S|www.fda.gov/medwatch.||
0859|080|S|   In Canada - Call your doctor for medical advice about side||
0859|081|S|effects. You may report side effects to Health Canada at||
0859|082|S|1-866-234-2345.||
0859|083|B|||
0859|084|P|PRECAUTIONS:  Before using hydrocortisone, tell your doctor or||
0859|085|P|pharmacist if you are allergic to it; or to other corticosteroids||
0859|086|P|(such as prednisone, triamcinolone); or if you have any other||
0859|087|P|allergies. This product may contain inactive ingredients, which||
0859|088|P|can cause allergic reactions or other problems. Talk to your||
0859|089|P|pharmacist for more details.||
0859|090|P|   If you have any health problems, consult your doctor or||
0859|091|P|pharmacist before using this product.||
0859|092|P|   If you have itching of the outer female genitals with vaginal||
0859|093|P|discharge, consult your doctor before using this product.||
0859|094|P|   Do not use if there is an infection or sore in the area to be||
0859|095|P|treated. Skin infections can become worse when this medication is||
0859|096|P|used. Tell your doctor promptly if redness, swelling, or||
0859|097|P|irritation does not improve.||
0859|098|P|   Before having surgery, tell your doctor or dentist about all||
0859|099|P|the products you use (including prescription drugs,||
0859|100|P|nonprescription drugs, and herbal products).||
0859|101|P|   Children may be more sensitive to the effects of too much||
0859|102|P|corticosteroid medication. Consult your doctor for more details.||
0859|103|P|   During pregnancy, this medication should be used only when||
0859|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
0859|105|P|   It is unknown if this drug passes into breast milk when||
0859|106|P|applied to the skin. Similar medications pass into breast milk||
0859|107|P|when taken by mouth. Consult your doctor before breastfeeding.||
0859|108|B|||
0859|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0859|110|I|medications work or increase your risk for serious side effects.||
0859|111|I|This document does not contain all possible drug interactions.||
0859|112|I|Keep a list of all the products you use (including||
0859|113|I|prescription/nonprescription drugs and herbal products) and share||
0859|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
0859|115|I|the dosage of any medicines without your doctor's approval.||
0859|116|B|||
0859|117|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0859|118|O|has overdosed and has serious symptoms such as passing out or||
0859|119|O|trouble breathing, call 911. Otherwise, call a poison control||
0859|120|O|center right away. US residents can call 1-800-222-1222. Canada||
0859|121|O|residents can call 1-844-764-7669.||
0859|122|B|||
0859|123|N|NOTES:  Do not share this medication with others.||
0859|124|N|   If prescribed by your doctor, use this medication for your||
0859|125|N|current condition only. Do not use it later for other skin||
0859|126|N|problems unless told to do so by your doctor. A different||
0859|127|N|medication may be necessary in those cases.||
0859|128|N|   Keep all medical and lab appointments.||
0859|129|B|||
0859|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0859|131|D|If it is near the time of the next dose, skip the missed dose.||
0859|132|D|Use your next dose at the regular time. Do not double the dose to||
0859|133|D|catch up.||
0859|134|B|||
0859|135|R|STORAGE:  Refer to the storage information printed on the||
0859|136|R|package. Protect from light and moisture. If you have any||
0859|137|R|questions about storage, ask your pharmacist. Keep all||
0859|138|R|medications away from children and pets.||
0859|139|R|   Do not flush medications down the toilet or pour them into a||
0859|140|R|drain unless instructed to do so. Properly discard this product||
0859|141|R|when it is expired or no longer needed. Consult your pharmacist||
0859|142|R|or local waste disposal company.||
0859|143|B|||
0859|144|A|Information last revised November 2025.||
0859|145|A|Copyright(c) 2025 First Databank, Inc.||
0859|146|B|||
0860|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0860|002|Z|does NOT have all possible information about this product. This||
0860|003|Z|information does not assure that this product is safe, effective,||
0860|004|Z|or appropriate for you. This information is not individual||
0860|005|Z|medical advice and does not substitute for the advice of your||
0860|006|Z|health care professional. Always ask your health care||
0860|007|Z|professional for complete information about this product and your||
0860|008|Z|specific health needs.||
0860|009|B|||
0860|010|T|FLUOCINONIDE/EMOLLIENT - TOPICAL||
0860|011|F|(flew-oh-SIH-no-nide)||
0860|012|B|||
0860|013|C|COMMON BRAND NAME(S): Lidex-E||
0860|014|B|||
0860|015|U|USES:  This medication is used to treat a variety of skin||
0860|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
0860|017|U|Fluocinonide is a strong corticosteroid. It reduces the swelling,||
0860|018|U|itching, and redness that can occur in these types of conditions.||
0860|019|U|The fluocinonide is in a water-washable emollient base.||
0860|020|U|Emollients soften and moisturize the skin, leading to decreased||
0860|021|U|itching and flaking. Emollients also help to protect the skin||
0860|022|U|against irritation.||
0860|023|B|||
0860|024|H|HOW TO USE:  Use this medication on the skin only. However, do||
0860|025|H|not use it on the face, groin, or underarms unless directed to do||
0860|026|H|so by your doctor.||
0860|027|H|   Wash and dry your hands. Before applying the medication, clean||
0860|028|H|and dry the affected area. Apply a thin film of the medication to||
0860|029|H|the affected area and gently rub in as directed by your doctor,||
0860|030|H|usually 2 to 4 times daily. Do not cover, bandage, or wrap the||
0860|031|H|area unless directed to do so by your doctor.||
0860|032|H|   After applying the medication, wash your hands unless you are||
0860|033|H|using this medication to treat the hands. When applying this||
0860|034|H|medication near the eyes, avoid getting it in the eyes because||
0860|035|H|doing so may worsen or cause glaucoma. Also, avoid getting this||
0860|036|H|medication in the nose or mouth. If you get the medication in||
0860|037|H|these areas, rinse with plenty of water. If irritation occurs or||
0860|038|H|continues, contact your doctor right away.||
0860|039|H|   Use this medication only for the condition for which it was||
0860|040|H|prescribed. Do not use it for longer than prescribed.||
0860|041|H|   Tell your doctor if your condition lasts or gets worse after 2||
0860|042|H|weeks.||
0860|043|B|||
0860|044|S|SIDE EFFECTS:  Burning, itching, irritation, or dryness may occur||
0860|045|S|when this medication is first applied to the skin. Acne, unusual||
0860|046|S|hair growth, or small red bumps on the skin (folliculitis) may||
0860|047|S|also occur. If any of these effects last or get worse, tell your||
0860|048|S|doctor or pharmacist promptly.||
0860|049|S|   Remember that this medication has been prescribed because your||
0860|050|S|doctor has judged that the benefit to you is greater than the||
0860|051|S|risk of side effects. Many people using this medication do not||
0860|052|S|have serious side effects.||
0860|053|S|   Tell your doctor right away if you have any serious side||
0860|054|S|effects, including: stretch marks, skin thinning/discoloration.||
0860|055|S|   Skin infections can become worse when this medication is used.||
0860|056|S|Tell your doctor promptly if redness, swelling, or irritation||
0860|057|S|does not improve.||
0860|058|S|   Rarely, it is possible this medication will be absorbed from||
0860|059|S|the skin into the bloodstream. This can lead to side effects of||
0860|060|S|too much corticosteroid. These side effects are more likely in||
0860|061|S|children, and in people who use this medication for a long time||
0860|062|S|or over large areas of the skin. Tell your doctor right away if||
0860|063|S|any of the following side effects occur: unusual/extreme||
0860|064|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0860|065|S|thirst/urination, vision problems.||
0860|066|S|   A very serious allergic reaction to this drug is rare.||
0860|067|S|However, get medical help right away if you notice any symptoms||
0860|068|S|of a serious allergic reaction, including: rash, itching/swelling||
0860|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0860|070|S|breathing.||
0860|071|S|   This is not a complete list of possible side effects. If you||
0860|072|S|notice other effects not listed above, contact your doctor or||
0860|073|S|pharmacist.||
0860|074|S|   In the US -||
0860|075|S|   Call your doctor for medical advice about side effects. You||
0860|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0860|077|S|www.fda.gov/medwatch.||
0860|078|S|   In Canada - Call your doctor for medical advice about side||
0860|079|S|effects. You may report side effects to Health Canada at||
0860|080|S|1-866-234-2345.||
0860|081|B|||
0860|082|P|PRECAUTIONS:  Before using fluocinonide/emollients, tell your||
0860|083|P|doctor or pharmacist if you are allergic to it; or to other||
0860|084|P|corticosteroids (such as hydrocortisone, prednisone); or if you||
0860|085|P|have any other allergies. This product may contain inactive||
0860|086|P|ingredients, which can cause allergic reactions or other||
0860|087|P|problems. Talk to your pharmacist for more details.||
0860|088|P|   Before using this medication, tell your doctor or pharmacist||
0860|089|P|your medical history, especially of: poor blood circulation,||
0860|090|P|immune system problems.||
0860|091|P|   Do not use if there is an infection or sore present in the||
0860|092|P|area to be treated.||
0860|093|P|   Rarely, using corticosteroid medications for a long time or||
0860|094|P|over large areas of skin can make it more difficult for your body||
0860|095|P|to respond to physical stress. Before having surgery or emergency||
0860|096|P|treatment, or if you get a serious illness/injury, tell your||
0860|097|P|doctor or dentist that you are using this medication or have used||
0860|098|P|this medication within the past few months.||
0860|099|P|   Though it is unlikely, this medication may temporarily slow||
0860|100|P|down a child's growth if used for a long time. See the doctor||
0860|101|P|regularly so your child's height can be checked.||
0860|102|P|   During pregnancy, this medication should be used only when||
0860|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
0860|104|P|   It is unknown if this drug passes into breast milk when||
0860|105|P|applied to the skin. Similar medications pass into breast milk||
0860|106|P|when taken by mouth. Consult your doctor before breastfeeding.||
0860|107|B|||
0860|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0860|109|I|medications work or increase your risk for serious side effects.||
0860|110|I|This document does not contain all possible drug interactions.||
0860|111|I|Keep a list of all the products you use (including||
0860|112|I|prescription/nonprescription drugs and herbal products) and share||
0860|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
0860|114|I|the dosage of any medicines without your doctor's approval.||
0860|115|B|||
0860|116|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0860|117|O|has overdosed and has serious symptoms such as passing out or||
0860|118|O|trouble breathing, call 911. Otherwise, call a poison control||
0860|119|O|center right away. US residents can call 1-800-222-1222. Canada||
0860|120|O|residents can call 1-844-764-7669.||
0860|121|B|||
0860|122|N|NOTES:  Do not share this medication with others.||
0860|123|N|   This medication has been prescribed for your current condition||
0860|124|N|only. Do not use it later for other skin problems unless told to||
0860|125|N|do so by your doctor. A different medication may be necessary in||
0860|126|N|those cases.||
0860|127|N|   Lab and/or medical tests (such as adrenal gland function) may||
0860|128|N|be done while you are using this medication, especially if you||
0860|129|N|use this drug for an extended period of time or apply it over||
0860|130|N|large areas of the body. Keep all medical and lab appointments.||
0860|131|N|Consult your doctor for more details.||
0860|132|B|||
0860|133|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0860|134|D|If it is near the time of the next dose, skip the missed dose.||
0860|135|D|Use your next dose at the regular time. Do not double the dose to||
0860|136|D|catch up.||
0860|137|B|||
0860|138|R|STORAGE:  Different brands of this medication may have different||
0860|139|R|storage requirements. Refer to the package labeling or ask your||
0860|140|R|pharmacist for the storage requirements for the brand you are||
0860|141|R|using. Keep all medications away from children and pets.||
0860|142|R|   Do not flush medications down the toilet or pour them into a||
0860|143|R|drain unless instructed to do so. Properly discard this product||
0860|144|R|when it is expired or no longer needed. Consult your pharmacist||
0860|145|R|or local waste disposal company.||
0860|146|B|||
0860|147|A|Information last revised May 2024.||
0860|148|A|Copyright(c) 2025 First Databank, Inc.||
0860|149|B|||
0862|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0862|002|Z|does NOT have all possible information about this product. This||
0862|003|Z|information does not assure that this product is safe, effective,||
0862|004|Z|or appropriate for you. This information is not individual||
0862|005|Z|medical advice and does not substitute for the advice of your||
0862|006|Z|health care professional. Always ask your health care||
0862|007|Z|professional for complete information about this product and your||
0862|008|Z|specific health needs.||
0862|009|B|||
0862|010|T|METHYLPREDNISOLONE ACETATE SUSPENSION - INJECTION||
0862|011|F|(METH-il-pred-NIS-oh-lone AS-e-tate)||
0862|012|B|||
0862|013|C|COMMON BRAND NAME(S): Depo-Medrol||
0862|014|B|||
0862|015|U|USES:  Methylprednisolone is used to treat pain and swelling that||
0862|016|U|occurs with arthritis and other joint disorders. This medication||
0862|017|U|may also be used to treat various conditions such as blood||
0862|018|U|disorders, severe allergic reactions, certain cancers, eye||
0862|019|U|conditions, skin/intestinal/kidney/lung diseases, and immune||
0862|020|U|system disorders. It decreases your immune system's response to||
0862|021|U|these conditions and reduces symptoms such as swelling, pain, and||
0862|022|U|allergic-type reactions. Talk to your doctor about the risks and||
0862|023|U|benefits of methylprednisolone, especially if it is to be||
0862|024|U|injected near your spine (epidural). Rare but serious side||
0862|025|U|effects may occur with epidural use. Methylprednisolone is a||
0862|026|U|corticosteroid hormone.||
0862|027|U|   Methylprednisolone may also be used with other medications in||
0862|028|U|hormone disorders.||
0862|029|B|||
0862|030|H|HOW TO USE:  Shake this medication well before using. This||
0862|031|H|medication is usually injected into a joint as directed by your||
0862|032|H|doctor. Methylprednisolone may also be injected into a muscle or||
0862|033|H|into abnormal skin tissue. Follow your doctor's directions||
0862|034|H|carefully. The dosage is based on your medical condition and||
0862|035|H|response to treatment. Do not increase your dose or use this drug||
0862|036|H|more often than prescribed without consulting your doctor. Your||
0862|037|H|condition will not improve any faster, and your risk of side||
0862|038|H|effects will increase.||
0862|039|H|   If you are using this medication at home, learn all||
0862|040|H|preparation and usage instructions from your health care||
0862|041|H|professional. This medication should appear milky white. Before||
0862|042|H|using, check this product for particles or discoloration. If||
0862|043|H|either is present, do not use the liquid. Learn how to store and||
0862|044|H|discard medical supplies safely.||
0862|045|H|   If this medication is injected into a joint, be careful how||
0862|046|H|much pressure you put on that joint, even if it is feeling||
0862|047|H|better. Ask your doctor how much you can move/use the joint while||
0862|048|H|it is healing.||
0862|049|H|   Do not stop using this medication without consulting your||
0862|050|H|doctor. Some conditions may become worse when this drug is||
0862|051|H|suddenly stopped. Your dose may need to be gradually decreased.||
0862|052|H|   If you suddenly stop using this medication, you may have||
0862|053|H|withdrawal symptoms (such as weakness, weight loss, nausea,||
0862|054|H|muscle pain, headache, tiredness, dizziness). To help prevent||
0862|055|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0862|056|H|more likely if you have used methylprednisolone for a long time||
0862|057|H|or in high doses. Tell your doctor or pharmacist right away if||
0862|058|H|you have withdrawal. See also Precautions section.||
0862|059|H|   Tell your doctor if your condition does not get better or if||
0862|060|H|it gets worse.||
0862|061|B|||
0862|062|S|SIDE EFFECTS:  Nausea, vomiting, heartburn, headache, dizziness,||
0862|063|S|trouble sleeping, appetite changes, increased sweating, acne, or||
0862|064|S|pain/redness/swelling at the injection site may occur. If any of||
0862|065|S|these effects last or get worse, tell your doctor or pharmacist||
0862|066|S|promptly.||
0862|067|S|   Remember that this medication has been prescribed because your||
0862|068|S|doctor has judged that the benefit to you is greater than the||
0862|069|S|risk of side effects. Many people using this medication do not||
0862|070|S|have serious side effects.||
0862|071|S|   This medication may make your blood sugar rise, which can||
0862|072|S|cause or worsen diabetes. Tell your doctor right away if you have||
0862|073|S|symptoms of high blood sugar such as increased thirst/urination.||
0862|074|S|If you already have diabetes, check your blood sugar regularly as||
0862|075|S|directed and share the results with your doctor. Your doctor may||
0862|076|S|need to adjust your diabetes medication, exercise program, or||
0862|077|S|diet.||
0862|078|S|   This medication may lower your ability to fight infections.||
0862|079|S|This may make you more likely to get a serious (rarely fatal)||
0862|080|S|infection or make any infection you have worse. Tell your doctor||
0862|081|S|right away if you have any signs of infection (such as sore||
0862|082|S|throat that doesn't go away, fever, chills, white patches in the||
0862|083|S|mouth).||
0862|084|S|   Tell your doctor right away if you have any serious side||
0862|085|S|effects, including: unusual weight gain, menstrual period||
0862|086|S|changes, bone/joint pain, easy bruising/bleeding, mental/mood||
0862|087|S|changes (such as mood swings, depression, agitation), muscle||
0862|088|S|weakness/pain, puffy face, slow wound healing, swelling of the||
0862|089|S|ankles/feet/hands, thinning skin, unusual hair/skin growth,||
0862|090|S|vision problems, fast/slow/irregular heartbeat, symptoms of||
0862|091|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
0862|092|S|black/tarry stools, vomit that looks like coffee grounds),||
0862|093|S|red/purple spots on the skin.||
0862|094|S|   Get medical help right away if you have any very serious side||
0862|095|S|effects, including: seizures.||
0862|096|S|   A very serious allergic reaction to this drug is rare.||
0862|097|S|However, get medical help right away if you notice any symptoms||
0862|098|S|of a serious allergic reaction, including: rash, itching/swelling||
0862|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0862|100|S|breathing.||
0862|101|S|   This is not a complete list of possible side effects. If you||
0862|102|S|notice other effects not listed above, contact your doctor or||
0862|103|S|pharmacist.||
0862|104|S|   In the US -||
0862|105|S|   Call your doctor for medical advice about side effects. You||
0862|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0862|107|S|www.fda.gov/medwatch.||
0862|108|S|   In Canada - Call your doctor for medical advice about side||
0862|109|S|effects. You may report side effects to Health Canada at||
0862|110|S|1-866-234-2345.||
0862|111|B|||
0862|112|P|PRECAUTIONS:  Before using methylprednisolone, tell your doctor||
0862|113|P|or pharmacist if you are allergic to it; or to prednisone; or if||
0862|114|P|you have any other allergies. This product may contain inactive||
0862|115|P|ingredients, which can cause allergic reactions or other||
0862|116|P|problems. Talk to your pharmacist for more details.||
0862|117|P|   Before using this medication, tell your doctor or pharmacist||
0862|118|P|your medical history, especially of: bleeding problems, blood||
0862|119|P|clots, brittle bones (osteoporosis), diabetes, eye diseases (such||
0862|120|P|as cataracts, glaucoma, herpes infection of the eye), heart||
0862|121|P|problems (such as heart failure, recent heart attack), high blood||
0862|122|P|pressure, current/ past infections (such as those caused by||
0862|123|P|tuberculosis, threadworm, herpes, fungus), kidney disease, liver||
0862|124|P|disease (such as hepatitis B), mental/mood conditions (such as||
0862|125|P|psychosis, anxiety, depression), stomach/intestinal problems||
0862|126|P|(such as diverticulitis, ulcer, ulcerative colitis), seizures, a||
0862|127|P|certain adrenal gland tumor (pheochromocytoma).||
0862|128|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0862|129|P|can make you more dizzy. Do not drive, use machinery, or do||
0862|130|P|anything that needs alertness until you can do it safely. Talk to||
0862|131|P|your doctor if you are using marijuana (cannabis).||
0862|132|P|   This medication may cause stomach bleeding. Daily use of||
0862|133|P|alcohol while using this medication may increase your risk for||
0862|134|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
0862|135|P|or pharmacist for more information.||
0862|136|P|   Methylprednisolone can make you more likely to get infections||
0862|137|P|or may make current infections worse. Stay away from anyone who||
0862|138|P|has an infection that may easily spread (such as chickenpox,||
0862|139|P|COVID-19, measles, flu). Talk to your doctor if you have been||
0862|140|P|exposed to an infection or for more details.||
0862|141|P|   Tell your health care professional that you are using||
0862|142|P|methylprednisolone before having any immunizations, vaccinations,||
0862|143|P|or skin tests. Avoid contact with people who have recently||
0862|144|P|received live vaccines (such as flu vaccine inhaled through the||
0862|145|P|nose).||
0862|146|P|   Before having surgery, tell your doctor or dentist about all||
0862|147|P|the products you use (including prescription drugs,||
0862|148|P|nonprescription drugs, and herbal products).||
0862|149|P|   Using corticosteroid medications for a long time can make it||
0862|150|P|more difficult for your body to respond to physical stress.||
0862|151|P|Before having surgery or emergency treatment, or if you get a||
0862|152|P|serious illness/injury, tell your doctor or dentist that you are||
0862|153|P|using this medication or have used this medication within the||
0862|154|P|past 12 months. Tell your doctor right away if you develop||
0862|155|P|unusual/extreme tiredness or weight loss. If you will be using||
0862|156|P|this medication for a long time, carry a warning card or medical||
0862|157|P|ID bracelet that identifies your use of this medication. See also||
0862|158|P|Medical Alert section.||
0862|159|P|   Older adults may be more sensitive to the side effects of this||
0862|160|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
0862|161|P|mental/mood changes (such as confusion).||
0862|162|P|   This medication may slow down a child's growth if used for a||
0862|163|P|long time. Consult the doctor or pharmacist for more details. See||
0862|164|P|the doctor regularly so your child's height and growth can be||
0862|165|P|checked.||
0862|166|P|   During pregnancy, this medication should be used only when||
0862|167|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
0862|168|P|risks and benefits with your doctor. Infants born to mothers who||
0862|169|P|use this medication for a long time during pregnancy may have||
0862|170|P|hormone problems. Tell your doctor right away if you notice||
0862|171|P|symptoms such as nausea/vomiting that doesn't stop, severe||
0862|172|P|diarrhea, or weakness in your newborn.||
0862|173|P|   This medication passes into breast milk but is unlikely to||
0862|174|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0862|175|B|||
0862|176|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0862|177|I|medications work or increase your risk for serious side effects.||
0862|178|I|This document does not contain all possible drug interactions.||
0862|179|I|Keep a list of all the products you use (including||
0862|180|I|prescription/nonprescription drugs and herbal products) and share||
0862|181|I|it with your doctor and pharmacist. Do not start, stop, or change||
0862|182|I|the dosage of any medicines without your doctor's approval.||
0862|183|I|   Some products that may interact with this drug include:||
0862|184|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
0862|185|I|also cause bleeding/bruising (including antiplatelet drugs such||
0862|186|I|as clopidogrel, "blood thinners" such as warfarin/dabigatran,||
0862|187|I|NSAIDs such as ibuprofen, celecoxib, aspirin, salicylates).||
0862|188|I|   If your doctor has told you to take low-dose aspirin to||
0862|189|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0862|190|I|you should keep taking the aspirin unless your doctor tells you||
0862|191|I|not to. Ask your doctor or pharmacist for more details.||
0862|192|I|   Other medications can affect the removal of methylprednisolone||
0862|193|I|from your body, which may affect how methylprednisolone works.||
0862|194|I|Examples include azole antifungals (such as ketoconazole),||
0862|195|I|cyclosporine, estrogens, HIV protease inhibitors (such as||
0862|196|I|darunavir), macrolide antibiotics (such as erythromycin),||
0862|197|I|ritonavir, St. John's wort, some drugs used to treat seizures||
0862|198|I|(such as phenytoin, phenobarbital), among others.||
0862|199|I|   This medication may interfere with certain lab tests (such as||
0862|200|I|skin tests), possibly causing false test results. Make sure lab||
0862|201|I|personnel and all your doctors know you use this drug.||
0862|202|B|||
0862|203|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0862|204|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0862|205|O|poison control center right away. US residents can call||
0862|206|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0862|207|B|||
0862|208|N|NOTES:  Do not share this medication with others.||
0862|209|N|   If this medication is used for a long time, lab and/or medical||
0862|210|N|tests (such as blood sugar/mineral levels, blood pressure, eye||
0862|211|N|exams, bone density tests, height/weight measurements) should be||
0862|212|N|done while you are using this medication. Keep all medical and||
0862|213|N|lab appointments. Consult your doctor for more details.||
0862|214|N|   This medication may cause bone loss (osteoporosis) when used||
0862|215|N|for a long time. Lifestyle changes that may help reduce the risk||
0862|216|N|of bone problems include doing weight-bearing exercise, stopping||
0862|217|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
0862|218|N|D. Talk to your doctor for more details.||
0862|219|B|||
0862|220|D|MISSED DOSE:  It is important to get each dose of this medication||
0862|221|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0862|222|D|right away for a new dosing schedule. Do not double the dose to||
0862|223|D|catch up.||
0862|224|B|||
0862|225|R|STORAGE:  Store at room temperature. Keep all medications away||
0862|226|R|from children and pets.||
0862|227|R|   Do not flush medications down the toilet or pour them into a||
0862|228|R|drain unless instructed to do so. Properly discard this product||
0862|229|R|when it is expired or no longer needed. Consult your pharmacist||
0862|230|R|or local waste disposal company.||
0862|231|B|||
0862|232|A|Information last revised September 2025.||
0862|233|A|Copyright(c) 2025 First Databank, Inc.||
0862|234|B|||
0863|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0863|002|Z|does NOT have all possible information about this product. This||
0863|003|Z|information does not assure that this product is safe, effective,||
0863|004|Z|or appropriate for you. This information is not individual||
0863|005|Z|medical advice and does not substitute for the advice of your||
0863|006|Z|health care professional. Always ask your health care||
0863|007|Z|professional for complete information about this product and your||
0863|008|Z|specific health needs.||
0863|009|B|||
0863|010|T|CARVEDILOL EXTENDED-RELEASE - ORAL||
0863|011|F|(KAR-ve-DIL-ol)||
0863|012|B|||
0863|013|C|COMMON BRAND NAME(S): Coreg CR||
0863|014|B|||
0863|015|W|WARNING:  Do not stop taking this medication without consulting||
0863|016|W|your doctor. Some conditions may become worse when you suddenly||
0863|017|W|stop this drug. Some people who have suddenly stopped taking||
0863|018|W|similar drugs have had chest pain, heart attack, and irregular||
0863|019|W|heartbeat. If your doctor decides you should no longer use this||
0863|020|W|drug, your doctor may direct you to gradually decrease your dose||
0863|021|W|over 1 to 2 weeks.||
0863|022|W|   When gradually stopping this medication, it is recommended||
0863|023|W|that you temporarily limit physical activity to decrease strain||
0863|024|W|on the heart. Get medical help right away if you develop chest||
0863|025|W|pain/tightness/pressure, chest pain spreading to the||
0863|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
0863|027|W|fast/irregular heartbeat.||
0863|028|B|||
0863|029|U|USES:  Carvedilol is used to treat high blood pressure and heart||
0863|030|U|failure. It is also used after a heart attack to improve the||
0863|031|U|chance of survival if your heart is not pumping well. Lowering||
0863|032|U|high blood pressure helps prevent strokes, heart attacks, and||
0863|033|U|kidney problems.||
0863|034|U|   This drug works by blocking the action of certain natural||
0863|035|U|substances in your body, such as epinephrine, on the heart and||
0863|036|U|blood vessels. This effect lowers your heart rate, blood||
0863|037|U|pressure, and strain on your heart. Carvedilol belongs to a class||
0863|038|U|of drugs known as alpha and beta blockers.||
0863|039|B|||
0863|040|V|OTHER USES:  This section contains uses of this drug that are not||
0863|041|V|listed in the approved professional labeling for the drug but||
0863|042|V|that may be prescribed by your health care professional. Use this||
0863|043|V|drug for a condition that is listed in this section only if it||
0863|044|V|has been so prescribed by your health care professional.||
0863|045|V|   This drug may also be used for a certain type of irregular||
0863|046|V|heartbeat (atrial fibrillation). It may also be used after a||
0863|047|V|heart attack to reduce the risk of another heart attack.||
0863|048|B|||
0863|049|H|HOW TO USE:  See also Warning section.||
0863|050|H|   Read the Patient Information Leaflet if available from your||
0863|051|H|pharmacist before you start taking carvedilol and each time you||
0863|052|H|get a refill. If you have any questions, ask your doctor or||
0863|053|H|pharmacist.||
0863|054|H|   Take this medication by mouth with food as directed by your||
0863|055|H|doctor, usually once daily in the morning.||
0863|056|H|   Swallow the capsule whole. Do not crush or chew the capsule.||
0863|057|H|   If you cannot swallow the capsule, you may open the capsule||
0863|058|H|and sprinkle the beads over cool, smooth applesauce. Do not chew||
0863|059|H|the mixture because doing so may cause the drug to be released||
0863|060|H|too quickly, increasing side effects. Swallow all of the mixture||
0863|061|H|right away. Do not prepare the mixture ahead of time for later||
0863|062|H|use.||
0863|063|H|   The dosage is based on your medical condition and response to||
0863|064|H|treatment. To reduce your risk of side effects, your doctor may||
0863|065|H|direct you to start this medication at a low dose and gradually||
0863|066|H|increase your dose. Follow your doctor's instructions carefully.||
0863|067|H|   Take this medication regularly to get the most benefit from||
0863|068|H|it. To help you remember, take it at the same time each day.||
0863|069|H|   For the treatment of high blood pressure, it may take 1 to 2||
0863|070|H|weeks before you get the full benefit of this drug. Keep taking||
0863|071|H|this medication even if you feel well. Most people with high||
0863|072|H|blood pressure do not feel sick.||
0863|073|H|   Tell your doctor if your condition does not get better or if||
0863|074|H|it gets worse (for example, your blood pressure readings remain||
0863|075|H|high or increase, you have worsening symptoms of heart failure||
0863|076|H|like increased shortness of breath).||
0863|077|B|||
0863|078|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
0863|079|S|   Dizziness, lightheadedness, drowsiness, diarrhea, impotence,||
0863|080|S|or tiredness may occur. If any of these effects last or get||
0863|081|S|worse, tell your doctor or pharmacist promptly.||
0863|082|S|   To reduce the risk of dizziness and lightheadedness, get up||
0863|083|S|slowly when rising from a sitting or lying position. The risk of||
0863|084|S|dizziness is highest within 1 hour after you take your dose.||
0863|085|S|Starting treatment with a low dose and slowly increasing your||
0863|086|S|dose as directed by your doctor help to reduce the risk of||
0863|087|S|dizziness.||
0863|088|S|   This drug may reduce blood flow to your hands and feet,||
0863|089|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0863|090|S|warmly and avoid tobacco use.||
0863|091|S|   Remember that this medication has been prescribed because your||
0863|092|S|doctor has judged that the benefit to you is greater than the||
0863|093|S|risk of side effects. Many people using this medication do not||
0863|094|S|have serious side effects.||
0863|095|S|   Tell your doctor right away if you have any serious side||
0863|096|S|effects, including: very slow heartbeat, fainting, unusual||
0863|097|S|weakness, signs of kidney problems (such as change in the amount||
0863|098|S|of urine), numbness/tingling of the hands/feet, blue||
0863|099|S|fingers/toes, easy bruising/bleeding, mental/mood changes (such||
0863|100|S|as confusion, depression), seizures.||
0863|101|S|   Although this medication may be used to treat heart failure,||
0863|102|S|some people may rarely develop new or worsening symptoms of heart||
0863|103|S|failure, especially at the start of carvedilol treatment. Tell||
0863|104|S|your doctor right away if you develop any of these serious side||
0863|105|S|effects: shortness of breath, swelling ankles/feet, unusual||
0863|106|S|tiredness, unusual/sudden weight gain.||
0863|107|S|   A very serious allergic reaction to this drug is rare.||
0863|108|S|However, get medical help right away if you notice any symptoms||
0863|109|S|of a serious allergic reaction, including: rash, itching/swelling||
0863|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0863|111|S|breathing.||
0863|112|S|   This is not a complete list of possible side effects. If you||
0863|113|S|notice other effects not listed above, contact your doctor or||
0863|114|S|pharmacist.||
0863|115|S|   In the US -||
0863|116|S|   Call your doctor for medical advice about side effects. You||
0863|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0863|118|S|www.fda.gov/medwatch.||
0863|119|S|   In Canada - Call your doctor for medical advice about side||
0863|120|S|effects. You may report side effects to Health Canada at||
0863|121|S|1-866-234-2345.||
0863|122|B|||
0863|123|P|PRECAUTIONS:  Before taking carvedilol, tell your doctor or||
0863|124|P|pharmacist if you are allergic to it; or if you have any other||
0863|125|P|allergies. This product may contain inactive ingredients, which||
0863|126|P|can cause allergic reactions or other problems. Talk to your||
0863|127|P|pharmacist for more details.||
0863|128|P|   Before using this medication, tell your doctor or pharmacist||
0863|129|P|your medical history, especially of: certain types of||
0863|130|P|heartbeat/heart rhythm problems (such as slow/irregular||
0863|131|P|heartbeat, sick sinus syndrome, second- or third-degree||
0863|132|P|atrioventricular block), breathing problems (such as asthma,||
0863|133|P|chronic bronchitis, emphysema), severe heart failure requiring||
0863|134|P|hospitalization, liver disease, kidney disease, blood circulation||
0863|135|P|problems (such as Raynaud's disease, peripheral vascular||
0863|136|P|disease), serious allergic reactions including those needing||
0863|137|P|treatment with epinephrine, overactive thyroid disease||
0863|138|P|(hyperthyroidism), a certain adrenal gland tumor||
0863|139|P|(pheochromocytoma), other heart problems (such as Prinzmetal's||
0863|140|P|variant angina), a certain muscle disease (myasthenia gravis),||
0863|141|P|certain eye problems (cataracts, glaucoma).||
0863|142|P|   This drug may make you dizzy or drowsy or cause you to faint.||
0863|143|P|This is most likely to occur within 1 hour after taking your||
0863|144|P|dose, especially when you start carvedilol treatment or any time||
0863|145|P|your doctor increases your dose. During these periods, avoid||
0863|146|P|driving and doing hazardous tasks. Do not drive, use machinery,||
0863|147|P|or do anything that needs alertness until you can do it safely.||
0863|148|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0863|149|P|drowsy. Limit alcoholic beverages. Talk to your doctor if you are||
0863|150|P|using marijuana (cannabis).||
0863|151|P|   People who wear contact lenses may have dry eyes while taking||
0863|152|P|this medication.||
0863|153|P|   Before having surgery (including cataract/glaucoma eye||
0863|154|P|surgery), tell your doctor or dentist if you are taking or have||
0863|155|P|ever taken this medication, and about all the other products you||
0863|156|P|use (including prescription drugs, nonprescription drugs, and||
0863|157|P|herbal products).||
0863|158|P|   This product may prevent the fast/pounding heartbeat you would||
0863|159|P|usually feel when your blood sugar level falls too low||
0863|160|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0863|161|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0863|162|P|blood sugar level, such as dizziness and sweating, are not||
0863|163|P|affected by this drug.||
0863|164|P|   If you have diabetes, this product may make it harder to||
0863|165|P|control your blood sugar levels. Check your blood sugar levels||
0863|166|P|regularly as directed by your doctor. Tell your doctor right away||
0863|167|P|if you have symptoms of high blood sugar such as increased||
0863|168|P|thirst/urination. Your doctor may need to adjust your diabetes||
0863|169|P|medication, exercise program, or diet.||
0863|170|P|   Children may be at greater risk for low blood sugar||
0863|171|P|(hypoglycemia) while using this drug, especially if they are||
0863|172|P|vomiting or not eating regularly. To help prevent low blood||
0863|173|P|sugar, make sure children eat regularly. If your child cannot eat||
0863|174|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
0863|175|P|as sweating, shaking), tell the doctor right away.||
0863|176|P|   Older adults may be more sensitive to the side effects of this||
0863|177|P|drug, especially dizziness and lightheadedness.||
0863|178|P|   Tell your doctor if you are pregnant or plan to become||
0863|179|P|pregnant. You should not become pregnant while using carvedilol.||
0863|180|P|Carvedilol may harm an unborn baby. If you become pregnant, talk||
0863|181|P|to your doctor right away about the risks and benefits of this||
0863|182|P|medication.||
0863|183|P|   It is unknown if carvedilol passes into breast milk. However,||
0863|184|P|it is unlikely to pass into breast milk in large amounts. There||
0863|185|P|is a low risk that it may have undesirable effects on a nursing||
0863|186|P|infant. Consult your doctor before breastfeeding.||
0863|187|B|||
0863|188|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0863|189|I|medications work or increase your risk for serious side effects.||
0863|190|I|This document does not contain all possible drug interactions.||
0863|191|I|Keep a list of all the products you use (including||
0863|192|I|prescription/nonprescription drugs and herbal products) and share||
0863|193|I|it with your doctor and pharmacist. Do not start, stop, or change||
0863|194|I|the dosage of any medicines without your doctor's approval.||
0863|195|I|   One product that may interact with this drug is: fingolimod.||
0863|196|I|   Some products have ingredients that could raise your heart||
0863|197|I|rate or blood pressure or worsen your heart failure. Tell your||
0863|198|I|pharmacist what products you are using, and ask how to use them||
0863|199|I|safely (especially cough-and-cold products, diet aids, or NSAIDs||
0863|200|I|such as ibuprofen/naproxen).||
0863|201|B|||
0863|202|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0863|203|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0863|204|O|poison control center right away. US residents can call||
0863|205|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0863|206|O|Symptoms of overdose may include: very slow heartbeat, severe||
0863|207|O|dizziness, fainting, slow/shallow breathing, seizures.||
0863|208|B|||
0863|209|N|NOTES:  Do not share this medication with others.||
0863|210|N|   Lifestyle changes that may help this medication work better||
0863|211|N|include exercising, stopping smoking, and eating a||
0863|212|N|low-cholesterol/low-fat diet. Consult your doctor for more||
0863|213|N|details.||
0863|214|N|   Have your blood pressure and pulse (heart rate) checked||
0863|215|N|regularly while taking this medication. Learn how to monitor your||
0863|216|N|own blood pressure and pulse at home, and share the results with||
0863|217|N|your doctor.||
0863|218|N|   Lab and/or medical tests (such as kidney/liver function)||
0863|219|N|should be done while you are taking this medication. Keep all||
0863|220|N|medical and lab appointments. Consult your doctor for more||
0863|221|N|details.||
0863|222|B|||
0863|223|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0863|224|D|remember. If it is near the time of the next dose, skip the||
0863|225|D|missed dose. Take your next dose at the regular time. Do not||
0863|226|D|double the dose to catch up.||
0863|227|B|||
0863|228|R|STORAGE:  Store at room temperature away from light and moisture.||
0863|229|R|Do not store in the bathroom. Keep all medications away from||
0863|230|R|children and pets.||
0863|231|R|   Do not flush medications down the toilet or pour them into a||
0863|232|R|drain unless instructed to do so. Properly discard this product||
0863|233|R|when it is expired or no longer needed. Consult your pharmacist||
0863|234|R|or local waste disposal company.||
0863|235|B|||
0863|236|A|Information last revised August 2024.||
0863|237|A|Copyright(c) 2025 First Databank, Inc.||
0863|238|B|||
0864|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0864|002|Z|does NOT have all possible information about this product. This||
0864|003|Z|information does not assure that this product is safe, effective,||
0864|004|Z|or appropriate for you. This information is not individual||
0864|005|Z|medical advice and does not substitute for the advice of your||
0864|006|Z|health care professional. Always ask your health care||
0864|007|Z|professional for complete information about this product and your||
0864|008|Z|specific health needs.||
0864|009|B|||
0864|010|T|HYDROMORPHONE - INJECTION||
0864|011|F|(hye-droe-MOR-fone)||
0864|012|B|||
0864|013|C|COMMON BRAND NAME(S): Dilaudid, Dilaudid HP||
0864|014|B|||
0864|015|W|WARNING:  This medication comes in several strengths. Be sure you||
0864|016|W|are using the correct strength. The higher strength product||
0864|017|W|should only be used if you have been using opioid pain||
0864|018|W|medications for a long time. Use of the higher strength||
0864|019|W|medication by someone who is not regularly using opioid pain||
0864|020|W|relievers can cause very serious (possibly fatal) breathing||
0864|021|W|problems.||
0864|022|W|   Ask your doctor or pharmacist if you should have medication||
0864|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0864|024|W|Teach your family or household members about the signs of an||
0864|025|W|opioid overdose and how to treat it.||
0864|026|W|   Hydromorphone has a risk for abuse and addiction, which can||
0864|027|W|lead to overdose and death. Hydromorphone may also cause severe,||
0864|028|W|possibly fatal, breathing problems. To lower your risk, your||
0864|029|W|doctor should have you use the smallest dose of hydromorphone||
0864|030|W|that works, and use it for the shortest possible time. See also||
0864|031|W|How to Use section for more information about addiction.||
0864|032|W|   The risk for severe breathing problems is higher when you||
0864|033|W|start this medication and after a dose increase, or if you use||
0864|034|W|the wrong dose/strength. Using this medication with alcohol or||
0864|035|W|other drugs that can cause drowsiness or breathing problems may||
0864|036|W|cause very serious side effects, including death. Be sure you||
0864|037|W|know how to use hydromorphone and what other drugs you should||
0864|038|W|avoid using with it. See also Drug Interactions section. Get||
0864|039|W|medical help right away if any of these very serious side effects||
0864|040|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
0864|041|W|drowsiness/dizziness, difficulty waking up.||
0864|042|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0864|043|W|or abuse. If someone accidentally swallows this drug, get||
0864|044|W|emergency help right away.||
0864|045|W|   Before using this medication, women of childbearing age should||
0864|046|W|talk with their doctor(s) about the risks and benefits. Tell your||
0864|047|W|doctor if you are pregnant or if you plan to become pregnant.||
0864|048|W|During pregnancy, this medication should be used only when||
0864|049|W|clearly needed. It may slightly increase the risk of birth||
0864|050|W|defects if used during the first two months of pregnancy. Also,||
0864|051|W|using it for a long time or in high doses near the expected||
0864|052|W|delivery date may harm the unborn baby. To lessen the risk, use||
0864|053|W|the smallest effective dose for the shortest possible time.||
0864|054|W|Babies born to mothers who use this drug for a long time may||
0864|055|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0864|056|W|doctor right away if you notice any symptoms in your newborn baby||
0864|057|W|such as crying that doesn't stop, slow/shallow breathing,||
0864|058|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0864|059|W|difficulty gaining weight.||
0864|060|B|||
0864|061|U|USES:  This medication is used to relieve moderate to severe||
0864|062|U|pain. Hydromorphone is an opioid pain reliever. It acts on||
0864|063|U|certain centers in the brain to give you pain relief.||
0864|064|B|||
0864|065|H|HOW TO USE:  Depending on your product, this medication is given||
0864|066|H|by injection into a vein, into a muscle, or under the skin. Use||
0864|067|H|this product exactly as directed by your doctor. If you have||
0864|068|H|nausea after using this medication, ask your doctor or pharmacist||
0864|069|H|about ways to decrease it (such as lying down for 1 to 2 hours||
0864|070|H|with as little head movement as possible).||
0864|071|H|   The dosage is based on your medical condition and response to||
0864|072|H|treatment. Do not increase your dose, use the medication more||
0864|073|H|often, or use it for a longer time than prescribed. Properly stop||
0864|074|H|the medication when so directed.||
0864|075|H|   If you are using this medication at home, learn all||
0864|076|H|preparation and usage instructions from your health care||
0864|077|H|professional. Before using, check this product for particles or||
0864|078|H|discoloration. If either is present, do not use the liquid.||
0864|079|H|Before injecting each dose, clean the injection site with rubbing||
0864|080|H|alcohol. If this medication is given into a muscle or under the||
0864|081|H|skin, change the injection site each time to lessen injury under||
0864|082|H|the skin. Learn how to store and discard medical supplies safely.||
0864|083|H|   Pain medications work best if they are used when the first||
0864|084|H|signs of pain occur. If you wait until the pain has worsened, the||
0864|085|H|medication may not work as well.||
0864|086|H|   If you have ongoing pain (such as due to cancer), your doctor||
0864|087|H|may direct you to also take long-acting opioid medications. In||
0864|088|H|that case, this medication might be used for sudden||
0864|089|H|(breakthrough) pain only as needed. Other pain relievers (such as||
0864|090|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
0864|091|H|or pharmacist about using hydromorphone safely with other drugs.||
0864|092|H|   Suddenly stopping this medication may cause withdrawal,||
0864|093|H|especially if you have used it for a long time or in high doses.||
0864|094|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0864|095|H|Tell your doctor or pharmacist right away if you have any||
0864|096|H|withdrawal symptoms such as restlessness, mental/mood changes||
0864|097|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0864|098|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0864|099|H|aches, or sudden changes in behavior.||
0864|100|H|   When this medication is used for a long time, it may not work||
0864|101|H|as well. Talk with your doctor if this medication stops working||
0864|102|H|well.||
0864|103|H|   Though it helps many people, this medication may sometimes||
0864|104|H|cause addiction. This risk may be higher if you have a||
0864|105|H|mental/mood disorder or a substance use disorder (such as overuse||
0864|106|H|of or addiction to drugs/alcohol). Use this medication exactly as||
0864|107|H|prescribed to lower the risk of addiction. Ask your doctor or||
0864|108|H|pharmacist for more details.||
0864|109|H|   Tell your doctor if your pain does not get better or if it||
0864|110|H|gets worse, or if you have any new pain.||
0864|111|B|||
0864|112|S|SIDE EFFECTS:  See also Warning section.||
0864|113|S|   Nausea, vomiting, constipation, flushing, dry mouth,||
0864|114|S|lightheadedness, dizziness, drowsiness, or sweating may occur.||
0864|115|S|Pain, redness, or swelling at the injection site may also occur.||
0864|116|S|If any of these effects last or get worse, tell your doctor or||
0864|117|S|pharmacist promptly.||
0864|118|S|   To prevent constipation, eat dietary fiber, drink enough||
0864|119|S|water, and exercise. Consult your pharmacist for help in||
0864|120|S|selecting a laxative (such as a stimulant type with stool||
0864|121|S|softener).||
0864|122|S|   To reduce the risk of dizziness and lightheadedness, get up||
0864|123|S|slowly when rising from a sitting or lying position.||
0864|124|S|   Remember that this medication has been prescribed because your||
0864|125|S|doctor has judged that the benefit to you is greater than the||
0864|126|S|risk of side effects. Many people using this medication do not||
0864|127|S|have serious side effects.||
0864|128|S|   Tell your doctor right away if you have any serious side||
0864|129|S|effects, including: interrupted breathing during sleep (sleep||
0864|130|S|apnea), severe stomach/abdominal pain, fainting, mental/mood||
0864|131|S|changes (such as agitation, hallucinations, confusion), seizures,||
0864|132|S|difficulty urinating, signs of your adrenal glands not working||
0864|133|S|well (such as loss of appetite, unusual tiredness, weight loss),||
0864|134|S|trouble swallowing.||
0864|135|S|   Get medical help right away if you have any very serious side||
0864|136|S|effects, including: severe drowsiness/difficulty waking up,||
0864|137|S|slow/shallow/irregular breathing, fast/slow/irregular heartbeat.||
0864|138|S|   A very serious allergic reaction to this drug is rare.||
0864|139|S|However, get medical help right away if you notice any symptoms||
0864|140|S|of a serious allergic reaction, including: rash, itching/swelling||
0864|141|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0864|142|S|breathing.||
0864|143|S|   This is not a complete list of possible side effects. If you||
0864|144|S|notice other effects not listed above, contact your doctor or||
0864|145|S|pharmacist.||
0864|146|S|   In the US -||
0864|147|S|   Call your doctor for medical advice about side effects. You||
0864|148|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0864|149|S|www.fda.gov/medwatch.||
0864|150|S|   In Canada - Call your doctor for medical advice about side||
0864|151|S|effects. You may report side effects to Health Canada at||
0864|152|S|1-866-234-2345.||
0864|153|B|||
0864|154|P|PRECAUTIONS:  Before using hydromorphone, tell your doctor or||
0864|155|P|pharmacist if you are allergic to it; or to other opioid pain||
0864|156|P|medications (such as hydrocodone, morphine); or if you have any||
0864|157|P|other allergies. This product may contain inactive ingredients||
0864|158|P|(such as sulfites, latex), which can cause allergic reactions or||
0864|159|P|other problems. Talk to your pharmacist for more details.||
0864|160|P|   Before using this medication, tell your doctor or pharmacist||
0864|161|P|your medical history, especially of: stomach/intestinal problems||
0864|162|P|(such as blockage, constipation, diarrhea due to infection,||
0864|163|P|paralytic ileus), brain disorders (such as brain injury, tumor,||
0864|164|P|increased intracranial pressure, seizures), breathing problems||
0864|165|P|(such as emphysema, chronic bronchitis, asthma, sleep apnea),||
0864|166|P|heart problems (such as irregular heartbeat, heart failure, low||
0864|167|P|blood pressure), disease of the pancreas (such as pancreatitis),||
0864|168|P|mental/mood disorders (such as depression, psychosis), a certain||
0864|169|P|spinal problem (kyphoscoliosis), gallbladder disease, personal or||
0864|170|P|family history of a substance use disorder (such as overuse of or||
0864|171|P|addiction to drugs/alcohol), kidney disease, liver disease,||
0864|172|P|adrenal gland problem (such as Addison's disease), difficulty||
0864|173|P|urinating (such as due to enlarged prostate or urethral||
0864|174|P|stricture), underactive thyroid (hypothyroidism).||
0864|175|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0864|176|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0864|177|P|machinery, or do anything that needs alertness until you can do||
0864|178|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0864|179|P|are using marijuana (cannabis).||
0864|180|P|   Before having surgery, tell your doctor or dentist about all||
0864|181|P|the products you use (including prescription drugs,||
0864|182|P|nonprescription drugs, and herbal products).||
0864|183|P|   Older adults may be more sensitive to the side effects of this||
0864|184|P|drug, especially confusion, dizziness, drowsiness, and||
0864|185|P|slow/shallow breathing.||
0864|186|P|   During pregnancy, this medication should be used only when||
0864|187|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0864|188|P|benefits with your doctor. (See also Warning section.)||
0864|189|P|   This drug passes into breast milk and may have undesirable||
0864|190|P|effects on a nursing infant. Tell the doctor right away if your||
0864|191|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0864|192|P|breathing. Consult your doctor before breastfeeding.||
0864|193|B|||
0864|194|I|DRUG INTERACTIONS:  See also Warning section.||
0864|195|I|   Drug interactions may change how your medications work or||
0864|196|I|increase your risk for serious side effects. This document does||
0864|197|I|not contain all possible drug interactions. Keep a list of all||
0864|198|I|the products you use (including prescription/nonprescription||
0864|199|I|drugs and herbal products) and share it with your doctor and||
0864|200|I|pharmacist. Do not start, stop, or change the dosage of any||
0864|201|I|medicines without your doctor's approval.||
0864|202|I|   Some products that may interact with this drug include:||
0864|203|I|certain pain medications (mixed opioid agonists/antagonists such||
0864|204|I|as butorphanol, nalbuphine, pentazocine), cimetidine, drugs that||
0864|205|I|slow down the movement of the gut (such as belladonna alkaloids,||
0864|206|I|oxybutynin), naltrexone, samidorphan.||
0864|207|I|   The risk of serious side effects (such as slow/shallow||
0864|208|I|breathing, severe drowsiness/dizziness) may be increased if this||
0864|209|I|medication is used with other products that may also cause||
0864|210|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0864|211|I|if you are taking other products such as other opioid pain or||
0864|212|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0864|213|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0864|214|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0864|215|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0864|216|I|cetirizine, diphenhydramine).||
0864|217|I|   Check the labels on all your medicines (such as allergy or||
0864|218|I|cough-and-cold products) because they may contain ingredients||
0864|219|I|that cause drowsiness. Ask your pharmacist about using those||
0864|220|I|products safely.||
0864|221|I|   This medication may interfere with certain lab tests (such as||
0864|222|I|amylase/lipase levels), possibly causing false test results. Make||
0864|223|I|sure lab personnel and all your doctors know you use this drug.||
0864|224|B|||
0864|225|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0864|226|O|as passing out or trouble breathing, give them naloxone or||
0864|227|O|nalmefene if available, then call 911. If the person is awake and||
0864|228|O|has no symptoms, call a poison control center right away. US||
0864|229|O|residents can call 1-800-222-1222. Canada residents can call||
0864|230|O|1-844-764-7669. Symptoms of overdose may include: severe||
0864|231|O|drowsiness, inability to wake up, slow/shallow breathing, slow||
0864|232|O|heartbeat, cold/clammy skin, bluish skin/lips/nails, seizure,||
0864|233|O|coma.||
0864|234|B|||
0864|235|N|NOTES:  Do not share this medication with others. Sharing it is||
0864|236|N|against the law.||
0864|237|N|   This medication has been prescribed for your current condition||
0864|238|N|only. Do not use it later for another condition unless told to do||
0864|239|N|so by your doctor. A different medication may be necessary in||
0864|240|N|that case.||
0864|241|B|||
0864|242|D|MISSED DOSE:  If you are prescribed this medication on a regular||
0864|243|D|schedule and miss a dose, use it as soon as you remember. If it||
0864|244|D|is near the time of the next dose, skip the missed dose. Use your||
0864|245|D|next dose at the regular time. Do not double the dose to catch||
0864|246|D|up.||
0864|247|B|||
0864|248|R|STORAGE:  Store at room temperature away from light. Different||
0864|249|R|brands of this medication have different storage needs. Check the||
0864|250|R|product package for instructions on how to store your brand, or||
0864|251|R|ask your pharmacist. Keep all medications away from children and||
0864|252|R|pets.||
0864|253|R|   Do not flush medications down the toilet or pour them into a||
0864|254|R|drain unless instructed to do so. Properly discard this product||
0864|255|R|when it is expired or no longer needed. Consult your pharmacist||
0864|256|R|or local waste disposal company.||
0864|257|B|||
0864|258|A|Information last revised August 2025.||
0864|259|A|Copyright(c) 2025 First Databank, Inc.||
0864|260|B|||
0866|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0866|002|Z|does NOT have all possible information about this product. This||
0866|003|Z|information does not assure that this product is safe, effective,||
0866|004|Z|or appropriate for you. This information is not individual||
0866|005|Z|medical advice and does not substitute for the advice of your||
0866|006|Z|health care professional. Always ask your health care||
0866|007|Z|professional for complete information about this product and your||
0866|008|Z|specific health needs.||
0866|009|B|||
0866|010|T|SALICYLIC ACID (KERATOLYTIC) - TOPICAL||
0866|011|F|(SAL-i-SIL-ik)||
0866|012|B|||
0866|013|C|COMMON BRAND NAME(S): Duofilm, Virasal||
0866|014|B|||
0866|015|U|USES:  This medication is used on the skin to treat common skin||
0866|016|U|and foot (plantar) warts. Salicylic acid helps cause the wart to||
0866|017|U|gradually peel off. This medication is also used to help remove||
0866|018|U|corns and calluses. This product should not be used on the face||
0866|019|U|or on moles, birthmarks, warts with hair growing from them, or||
0866|020|U|genital/anal warts.||
0866|021|U|   Salicylic acid is a keratolytic. It belongs to the same class||
0866|022|U|of drugs as aspirin (salicylates). It works by increasing the||
0866|023|U|amount of moisture in the skin and dissolving the substance that||
0866|024|U|causes the skin cells to stick together. This makes it easier to||
0866|025|U|shed the skin cells. Warts are caused by a virus. Salicylic acid||
0866|026|U|does not affect the virus.||
0866|027|B|||
0866|028|H|HOW TO USE:  Follow all directions on the product package. If you||
0866|029|H|have any questions, ask your doctor or pharmacist.||
0866|030|H|   This medication is for use on the skin only. To avoid||
0866|031|H|irritation, do not let this medication come into contact with||
0866|032|H|your eyes, nose, mouth, groin, or any broken skin. If you do get||
0866|033|H|the medication in those areas, flush the area with cool water for||
0866|034|H|15 minutes. Wash hands after use.||
0866|035|H|   First, soak the corn, callus, or wart in warm water for about||
0866|036|H|5 minutes to soften the treatment area. Dry thoroughly. Your||
0866|037|H|doctor may direct you to use a pumice stone, callus file, or||
0866|038|H|emery board to carefully remove the top dead layers of skin after||
0866|039|H|soaking and before applying the medication. This dead skin||
0866|040|H|removal is only to help the medication work better. Do not try to||
0866|041|H|rub the wart or callus off.||
0866|042|H|   If you are using a liquid/gel, apply a few drops or a thin||
0866|043|H|coat of the medication to cover the entire wart, callus, or corn||
0866|044|H|using the applicator if provided. Be careful to apply it only to||
0866|045|H|the affected area and not the surrounding skin. Let dry for 5||
0866|046|H|minutes. Depending on the brand used, you may need to apply the||
0866|047|H|medication twice with each treatment. Check your product package||
0866|048|H|and follow the directions carefully. You may cover the area||
0866|049|H|loosely with a bandage. Repeat this procedure 1 to 2 times daily||
0866|050|H|for up to 2 weeks for corns and calluses and 12 weeks for warts||
0866|051|H|or as directed by your doctor.||
0866|052|H|   If you are using a medicated pad or bandage, you may need to||
0866|053|H|cut the pad so that it covers the treatment area completely but||
0866|054|H|does not touch the surrounding skin. Peel off the protective||
0866|055|H|covering and place the patch/bandage over the area. Leave in||
0866|056|H|place according to package directions. Remove and place a new||
0866|057|H|patch/bandage as directed (usually every 8 to 48 hours depending||
0866|058|H|on brand). Repeat this procedure for up to 2 weeks for corns and||
0866|059|H|calluses and 12 weeks for warts.||
0866|060|H|   Dosage is based on your medical condition, product type/brand,||
0866|061|H|and response to treatment. Do not use large amounts, apply this||
0866|062|H|medication more often, or use it for a longer period than||
0866|063|H|directed. Your condition will not clear faster, but the chance||
0866|064|H|for side effects may be increased.||
0866|065|H|   Use this medication regularly to get the most benefit from it.||
0866|066|H|To help you remember, use it at the same time each day.||
0866|067|H|   If your condition lasts or gets worse, or if you think you may||
0866|068|H|have a serious medical problem, get medical help right away.||
0866|069|B|||
0866|070|S|SIDE EFFECTS:  Slight burning, skin redness, and peeling may||
0866|071|S|occur. These effects are expected. If any of these effects||
0866|072|S|worsen, tell your doctor or pharmacist promptly.||
0866|073|S|   If your doctor has directed you to use this medication,||
0866|074|S|remember that your doctor has judged that the benefit to you is||
0866|075|S|greater than the risk of side effects. Many people using this||
0866|076|S|medication do not have serious side effects.||
0866|077|S|   Tell your doctor right away if you have any serious side||
0866|078|S|effects, including: spreading skin redness around the treated||
0866|079|S|area, signs of infection (such as pus, milky/bloody discharge),||
0866|080|S|formation of a deep sore (ulcer) at the treatment site.||
0866|081|S|   A very serious allergic reaction to this drug is rare.||
0866|082|S|However, get medical help right away if you notice any symptoms||
0866|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0866|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0866|085|S|breathing.||
0866|086|S|   This is not a complete list of possible side effects. If you||
0866|087|S|notice other effects not listed above, contact your doctor or||
0866|088|S|pharmacist.||
0866|089|S|   In the US -||
0866|090|S|   Call your doctor for medical advice about side effects. You||
0866|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0866|092|S|www.fda.gov/medwatch.||
0866|093|S|   In Canada - Call your doctor for medical advice about side||
0866|094|S|effects. You may report side effects to Health Canada at||
0866|095|S|1-866-234-2345.||
0866|096|B|||
0866|097|P|PRECAUTIONS:  Before using salicylic acid, tell your doctor or||
0866|098|P|pharmacist if you are allergic to it; or to nonsteroidal||
0866|099|P|anti-inflammatory drugs-NSAIDs (such as aspirin, ibuprofen,||
0866|100|P|naproxen); or if you have any other allergies. This product may||
0866|101|P|contain inactive ingredients, which can cause allergic reactions||
0866|102|P|or other problems. Talk to your pharmacist for more details.||
0866|103|P|   Before using this medication, tell your doctor or pharmacist||
0866|104|P|your medical history, especially of: diabetes, poor blood||
0866|105|P|circulation (such as peripheral vascular disease), skin||
0866|106|P|infection/irritation.||
0866|107|P|   If you are going to have an MRI test, tell testing personnel||
0866|108|P|if you are using the patch. Some patches may contain metals that||
0866|109|P|can cause serious burns during an MRI. Ask your doctor whether||
0866|110|P|you will need to remove your patch before the test and apply a||
0866|111|P|new patch afterward, and how to do so properly.||
0866|112|P|   During pregnancy, this product should be used only when||
0866|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
0866|114|P|   It is unknown if this drug passes into breast milk. Consult||
0866|115|P|your doctor before breastfeeding.||
0866|116|B|||
0866|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0866|118|I|medications work or increase your risk for serious side effects.||
0866|119|I|This document does not contain all possible drug interactions.||
0866|120|I|Keep a list of all the products you use (including||
0866|121|I|prescription/nonprescription drugs and herbal products) and share||
0866|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
0866|123|I|the dosage of any medicines without your doctor's approval.||
0866|124|B|||
0866|125|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0866|126|O|has overdosed and has serious symptoms such as passing out or||
0866|127|O|trouble breathing, call 911. Otherwise, call a poison control||
0866|128|O|center right away. US residents can call 1-800-222-1222. Canada||
0866|129|O|residents can call 1-844-764-7669.||
0866|130|B|||
0866|131|N|NOTES:  If your doctor has prescribed this medication for you, do||
0866|132|N|not share it with others.||
0866|133|B|||
0866|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0866|135|D|If it is near the time of the next dose, skip the missed dose.||
0866|136|D|Use your next dose at the regular time. Do not double the dose to||
0866|137|D|catch up.||
0866|138|B|||
0866|139|R|STORAGE:  Store at room temperature. Different brands of this||
0866|140|R|medication have different storage needs. Check the product||
0866|141|R|package for instructions on how to store your brand, or ask your||
0866|142|R|pharmacist. Keep all medications away from children and pets.||
0866|143|R|   Do not flush medications down the toilet or pour them into a||
0866|144|R|drain unless instructed to do so. Properly discard this product||
0866|145|R|when it is expired or no longer needed. Consult your pharmacist||
0866|146|R|or local waste disposal company.||
0866|147|B|||
0866|148|A|Information last revised May 2024.||
0866|149|A|Copyright(c) 2025 First Databank, Inc.||
0866|150|B|||
0867|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0867|002|Z|does NOT have all possible information about this product. This||
0867|003|Z|information does not assure that this product is safe, effective,||
0867|004|Z|or appropriate for you. This information is not individual||
0867|005|Z|medical advice and does not substitute for the advice of your||
0867|006|Z|health care professional. Always ask your health care||
0867|007|Z|professional for complete information about this product and your||
0867|008|Z|specific health needs.||
0867|009|B|||
0867|010|T|CLOBETASONE - TOPICAL||
0867|011|F|(kloe-BAY-ta-sone)||
0867|012|B|||
0867|013|U|USES:  This medication is used to treat a variety of skin||
0867|014|U|conditions (such as eczema, seborrheic dermatitis). Clobetasone||
0867|015|U|helps reduce swelling, itching, and redness. It is a||
0867|016|U|medium-strength medication in the class of drugs known as||
0867|017|U|anti-inflammatory corticosteroids.||
0867|018|B|||
0867|019|H|HOW TO USE:  This medication is for use on the skin only. Do not||
0867|020|H|use it on the face, groin, or underarms unless directed to do so||
0867|021|H|by your doctor.||
0867|022|H|   Wash your hands before using. Clean and dry the affected area||
0867|023|H|as directed. Then apply a small amount of medication in a thin||
0867|024|H|layer on the skin and rub in gently as directed by your doctor,||
0867|025|H|usually 2 to 3 times daily. Wash your hands after use, unless you||
0867|026|H|are using this product to treat the hands.||
0867|027|H|   Do not bandage, cover, or wrap the treated area unless you are||
0867|028|H|instructed to do so by your doctor.||
0867|029|H|   Do not use large amounts of this medication or apply this more||
0867|030|H|often or for a longer period than directed. Doing so may increase||
0867|031|H|the absorption of this medication into your blood, an effect that||
0867|032|H|may increase your risk of side effects. Ask your doctor about||
0867|033|H|ways to reduce this risk if you have large areas of the body to||
0867|034|H|be treated. Adults should not use more than 100 grams of this||
0867|035|H|medication in a week unless directed by the doctor.||
0867|036|H|   Avoid getting this medication in your eyes, nose, or mouth. If||
0867|037|H|this occurs, wipe off the medication and rinse thoroughly with||
0867|038|H|water. Caution is advised if you are using this medication near||
0867|039|H|the eyes because doing so may worsen or cause increased pressure||
0867|040|H|in the eyes (glaucoma). Ask your doctor for more information.||
0867|041|H|   Tell your doctor if your condition does not get better after 1||
0867|042|H|week.||
0867|043|B|||
0867|044|S|SIDE EFFECTS:  Burning, redness, irritation, or dryness of the||
0867|045|S|skin may occur. If any of these effects last or get worse, tell||
0867|046|S|your doctor or pharmacist promptly.||
0867|047|S|   Remember that this medication has been prescribed because your||
0867|048|S|doctor has judged that the benefit to you is greater than the||
0867|049|S|risk of side effects. Many people using this medication do not||
0867|050|S|have serious side effects.||
0867|051|S|   Tell your doctor right away if you have any serious side||
0867|052|S|effects, including: stretch marks, skin thinning/discoloration,||
0867|053|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
0867|054|S|(folliculitis).||
0867|055|S|   Rarely, use of this medication for prolonged or repeated||
0867|056|S|periods may result in skin infections (such as those caused by||
0867|057|S|fungi, bacteria). Contact your doctor if you notice any unusual||
0867|058|S|skin symptoms or if your condition does not improve. If you||
0867|059|S|develop an infection, you will need another medication to treat||
0867|060|S|it.||
0867|061|S|   Rarely, it is possible this medication will be absorbed from||
0867|062|S|the skin into the bloodstream. This can lead to side effects of||
0867|063|S|too much corticosteroid. These side effects are more likely in||
0867|064|S|children, and in people who use this medication for a long time||
0867|065|S|or over large areas of the skin. Tell your doctor right away if||
0867|066|S|any of the following side effects occur: unusual/extreme||
0867|067|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0867|068|S|thirst/urination, vision problems.||
0867|069|S|   A very serious allergic reaction to this drug is rare.||
0867|070|S|However, get medical help right away if you notice any symptoms||
0867|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0867|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0867|073|S|breathing.||
0867|074|S|   This is not a complete list of possible side effects. If you||
0867|075|S|notice other effects not listed above, contact your doctor or||
0867|076|S|pharmacist.||
0867|077|S|   In the US -||
0867|078|S|   Call your doctor for medical advice about side effects. You||
0867|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0867|080|S|www.fda.gov/medwatch.||
0867|081|S|   In Canada - Call your doctor for medical advice about side||
0867|082|S|effects. You may report side effects to Health Canada at||
0867|083|S|1-866-234-2345.||
0867|084|B|||
0867|085|P|PRECAUTIONS:  Before using clobetasone, tell your doctor or||
0867|086|P|pharmacist if you are allergic to it; or to other corticosteroids||
0867|087|P|(such as hydrocortisone, prednisone); or if you have any other||
0867|088|P|allergies. This product may contain inactive ingredients, which||
0867|089|P|can cause allergic reactions or other problems. Talk to your||
0867|090|P|pharmacist for more details.||
0867|091|P|   Before using this medication, tell your doctor or pharmacist||
0867|092|P|your medical history, especially of: skin infection (such as||
0867|093|P|herpes simplex, chickenpox), poor blood circulation, a weakened||
0867|094|P|immune system.||
0867|095|P|   Rarely, using corticosteroid medications for a long time or||
0867|096|P|over large areas of skin can make it more difficult for your body||
0867|097|P|to respond to physical stress. Before having surgery or emergency||
0867|098|P|treatment, or if you get a serious illness/injury, tell your||
0867|099|P|doctor or dentist that you are using this medication or have used||
0867|100|P|this medication within the past few months.||
0867|101|P|   Though it is unlikely, this medication may temporarily slow||
0867|102|P|down a child's growth if used for a long time. See the doctor||
0867|103|P|regularly so your child's height can be checked.||
0867|104|P|   During pregnancy, this medication should be used only when||
0867|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
0867|106|P|   It is unknown if this drug passes into breast milk. Consult||
0867|107|P|your doctor before breastfeeding.||
0867|108|B|||
0867|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0867|110|I|medications work or increase your risk for serious side effects.||
0867|111|I|This document does not contain all possible drug interactions.||
0867|112|I|Keep a list of all the products you use (including||
0867|113|I|prescription/nonprescription drugs and herbal products) and share||
0867|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
0867|115|I|the dosage of any medicines without your doctor's approval.||
0867|116|B|||
0867|117|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0867|118|O|has overdosed and has serious symptoms such as passing out or||
0867|119|O|trouble breathing, call 911. Otherwise, call a poison control||
0867|120|O|center right away. US residents can call 1-800-222-1222. Canada||
0867|121|O|residents can call 1-844-764-7669.||
0867|122|B|||
0867|123|N|NOTES:  Do not share this medication with others.||
0867|124|N|   This medication has been prescribed for your current condition||
0867|125|N|only. Do not use it later for another skin problem unless told to||
0867|126|N|do so by your doctor. A different medication may be necessary in||
0867|127|N|that case.||
0867|128|N|   Lab and/or medical tests (such as adrenal gland function) may||
0867|129|N|be done while you are using this medication, especially if you||
0867|130|N|use this drug for an extended period of time or apply it over||
0867|131|N|large areas of the body. Keep all medical and lab appointments.||
0867|132|N|Consult your doctor for more details.||
0867|133|B|||
0867|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0867|135|D|If it is near the time of the next dose, skip the missed dose.||
0867|136|D|Use your next dose at the regular time. Do not double the dose to||
0867|137|D|catch up.||
0867|138|B|||
0867|139|R|STORAGE:  Store at room temperature. Keep all medications away||
0867|140|R|from children and pets.||
0867|141|R|   Do not flush medications down the toilet or pour them into a||
0867|142|R|drain unless instructed to do so. Properly discard this product||
0867|143|R|when it is expired or no longer needed. Consult your pharmacist||
0867|144|R|or local waste disposal company.||
0867|145|B|||
0867|146|A|Information last revised November 2024.||
0867|147|A|Copyright(c) 2025 First Databank, Inc.||
0867|148|B|||
0868|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0868|002|Z|does NOT have all possible information about this product. This||
0868|003|Z|information does not assure that this product is safe, effective,||
0868|004|Z|or appropriate for you. This information is not individual||
0868|005|Z|medical advice and does not substitute for the advice of your||
0868|006|Z|health care professional. Always ask your health care||
0868|007|Z|professional for complete information about this product and your||
0868|008|Z|specific health needs.||
0868|009|B|||
0868|010|T|CLINDAMYCIN/TRETINOIN GEL - TOPICAL||
0868|011|F|(KLIN-da-MYE-sin/TREt-i-noyn)||
0868|012|B|||
0868|013|C|COMMON BRAND NAME(S): Ziana||
0868|014|B|||
0868|015|U|USES:  This combination medication is used to treat acne. It||
0868|016|U|helps decrease the number and severity of acne pimples and helps||
0868|017|U|pimples that do develop to heal more quickly. Tretinoin belongs||
0868|018|U|to a class of medications called retinoids. It works by affecting||
0868|019|U|the growth of skin cells. Clindamycin is an antibiotic that stops||
0868|020|U|the growth of bacteria that cause acne.||
0868|021|B|||
0868|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0868|023|H|from your pharmacist before you start using this product and each||
0868|024|H|time you get a refill. If you have any questions, ask your doctor||
0868|025|H|or pharmacist.||
0868|026|H|   Wash your hands before applying this medication. Gently clean||
0868|027|H|the affected skin with a mild/soapless cleanser and pat dry. Use||
0868|028|H|your fingertips to apply a small amount of medication (about the||
0868|029|H|size of a pea) in a thin layer over the face as directed by your||
0868|030|H|doctor, usually once daily at bedtime. Be careful to avoid the||
0868|031|H|eyes and lip area.||
0868|032|H|   Use this medication on the skin only. Do not apply to the||
0868|033|H|inner lip area or inside the nose/mouth. Do not apply to cut,||
0868|034|H|scraped, sunburned, or eczema-affected skin.||
0868|035|H|   Avoid getting this medication in your eyes. If this occurs,||
0868|036|H|flush with large amounts of water. Call your doctor if eye||
0868|037|H|irritation develops. Wash your hands after using the medication||
0868|038|H|to avoid accidentally getting it in your eyes.||
0868|039|H|   During the first few weeks of using this product, your acne||
0868|040|H|might appear worse because the medication is working on pimples||
0868|041|H|forming inside the skin. It may take several weeks to notice||
0868|042|H|results from this medication.||
0868|043|H|   Use it regularly in order to get the most benefit from it. To||
0868|044|H|help you remember, use it at the same time each day. Do not use a||
0868|045|H|larger amount or use it more often than recommended. Your skin||
0868|046|H|will not improve any faster, but your risk of redness, peeling,||
0868|047|H|and pain will increase.||
0868|048|H|   Tell your doctor if your condition lasts or gets worse.||
0868|049|B|||
0868|050|S|SIDE EFFECTS:  Skin redness, dryness, itching, peeling, mild||
0868|051|S|burning/stinging, or worsening of acne may occur during the first||
0868|052|S|2 to 4 weeks of using the medication. These effects usually||
0868|053|S|decrease with continued use. A daytime moisturizer may be helpful||
0868|054|S|for very dry skin (see Notes). If any of these effects last or||
0868|055|S|get worse, tell your doctor or pharmacist promptly. Your doctor||
0868|056|S|may want you to decrease how often you use the medication or stop||
0868|057|S|using it.||
0868|058|S|   Remember that this medication has been prescribed because your||
0868|059|S|doctor has judged that the benefit to you is greater than the||
0868|060|S|risk of side effects. Many people using this medication do not||
0868|061|S|have serious side effects.||
0868|062|S|   Tell your doctor right away if you have any serious side||
0868|063|S|effects, including: blistering/crusting of the skin, severe||
0868|064|S|burning/swelling of the skin.||
0868|065|S|   This medication may be absorbed into your bloodstream and very||
0868|066|S|rarely cause a severe intestinal condition due to a bacteria||
0868|067|S|called C. difficile. This condition may occur during treatment or||
0868|068|S|weeks to months after treatment has stopped. Tell your doctor||
0868|069|S|right away if you develop: diarrhea that doesn't stop, abdominal||
0868|070|S|or stomach pain/cramping, blood/mucus in your stool.||
0868|071|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0868|072|S|products because they may make symptoms worse.||
0868|073|S|   A very serious allergic reaction to this drug is rare.||
0868|074|S|However, get medical help right away if you notice any symptoms||
0868|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0868|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0868|077|S|breathing.||
0868|078|S|   This is not a complete list of possible side effects. If you||
0868|079|S|notice other effects not listed above, contact your doctor or||
0868|080|S|pharmacist.||
0868|081|S|   In the US -||
0868|082|S|   Call your doctor for medical advice about side effects. You||
0868|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0868|084|S|www.fda.gov/medwatch.||
0868|085|S|   In Canada - Call your doctor for medical advice about side||
0868|086|S|effects. You may report side effects to Health Canada at||
0868|087|S|1-866-234-2345.||
0868|088|B|||
0868|089|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0868|090|P|pharmacist if you are allergic to clindamycin or to tretinoin; or||
0868|091|P|to lincomycin; or to vitamin A-related drugs (other retinoids||
0868|092|P|such as isotretinoin); or if you have any other allergies. This||
0868|093|P|product may contain inactive ingredients, which can cause||
0868|094|P|allergic reactions or other problems. Talk to your pharmacist for||
0868|095|P|more details.||
0868|096|P|   Before using this medication, tell your doctor or pharmacist||
0868|097|P|your medical history, especially of: certain intestinal problems||
0868|098|P|(such as regional enteritis, ulcerative colitis, colitis caused||
0868|099|P|by the use of antibiotics, C. difficile-associated diarrhea,||
0868|100|P|Crohn's disease), eczema.||
0868|101|P|   This medication may make you more sensitive to the sun. Limit||
0868|102|P|your time in the sun. Avoid tanning booths and sunlamps. Weather||
0868|103|P|extremes such as wind or cold may also be irritating to the skin.||
0868|104|P|Use sunscreen daily and wear protective clothing when outdoors.||
0868|105|P|Tell your doctor right away if you get sunburned or have skin||
0868|106|P|blisters/redness. Wait until your skin has completely recovered||
0868|107|P|from a sunburn before using this product.||
0868|108|P|   Avoid electrolysis, waxing, and chemical depilatories for hair||
0868|109|P|removal on the treated areas while using this product.||
0868|110|P|   Before having surgery, tell your doctor or dentist about all||
0868|111|P|the products you use (including prescription drugs,||
0868|112|P|nonprescription drugs, and herbal products).||
0868|113|P|   During pregnancy, this medication should be used only when||
0868|114|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0868|115|P|benefits with your doctor.||
0868|116|P|   It is unknown if this drug passes into breast milk. Consult||
0868|117|P|your doctor before breastfeeding.||
0868|118|B|||
0868|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0868|120|I|medications work or increase your risk for serious side effects.||
0868|121|I|This document does not contain all possible drug interactions.||
0868|122|I|Keep a list of all the products you use (including||
0868|123|I|prescription/nonprescription drugs and herbal products) and share||
0868|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
0868|125|I|the dosage of any medicines without your doctor's approval.||
0868|126|I|   Avoid using other skin products that are harsh, irritating, or||
0868|127|I|drying on the treated area. These products include hair perming||
0868|128|I|solutions, alcohol/lime/menthol-containing products (such as||
0868|129|I|astringents, toners, shaving lotion), medicated or abrasive soaps||
0868|130|I|or cleansers, soaps and cosmetics with a strong drying effect||
0868|131|I|(such as alpha hydroxy acids, glycolic acid), and products||
0868|132|I|containing sulfur, resorcinol, or salicylic acid.||
0868|133|I|   Benzoyl peroxide can be very irritating and may decrease the||
0868|134|I|effectiveness of this medication if the two products are applied||
0868|135|I|at the same time. Talk with your doctor or pharmacist about using||
0868|136|I|prescription and non-prescription benzoyl peroxide products||
0868|137|I|safely.||
0868|138|B|||
0868|139|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0868|140|O|has overdosed and has serious symptoms such as passing out or||
0868|141|O|trouble breathing, call 911. Otherwise, call a poison control||
0868|142|O|center right away. US residents can call 1-800-222-1222. Canada||
0868|143|O|residents can call 1-844-764-7669.||
0868|144|B|||
0868|145|N|NOTES:  Do not share this medication with others.||
0868|146|N|   Some cosmetics and soaps may worsen your acne. Moisturizers||
0868|147|N|may be safe to use. When buying cosmetics, moisturizers, or other||
0868|148|N|skin care products, check the label for "non-comedogenic" or||
0868|149|N|"non-acnegenic." These products are unlikely to worsen your acne.||
0868|150|N|Ask your doctor or pharmacist which products are safe to use.||
0868|151|N|Remember, acne is not caused by dirt. Cleaning your skin too||
0868|152|N|often or too vigorously can irritate your skin and worsen acne.||
0868|153|B|||
0868|154|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0868|155|D|If it is near the time of the next dose, skip the missed dose.||
0868|156|D|Use your next dose at the regular time. Do not double the dose to||
0868|157|D|catch up.||
0868|158|B|||
0868|159|R|STORAGE:  Store at room temperature away from light. Do not||
0868|160|R|freeze. This medication is flammable. Keep it away from heat and||
0868|161|R|open flame. Keep all medications away from children and pets.||
0868|162|R|   Do not flush medications down the toilet or pour them into a||
0868|163|R|drain unless instructed to do so. Properly discard this product||
0868|164|R|when it is expired or no longer needed. Consult your pharmacist||
0868|165|R|or local waste disposal company.||
0868|166|B|||
0868|167|A|Information last revised July 2025.||
0868|168|A|Copyright(c) 2025 First Databank, Inc.||
0868|169|B|||
0872|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0872|002|Z|does NOT have all possible information about this product. This||
0872|003|Z|information does not assure that this product is safe, effective,||
0872|004|Z|or appropriate for you. This information is not individual||
0872|005|Z|medical advice and does not substitute for the advice of your||
0872|006|Z|health care professional. Always ask your health care||
0872|007|Z|professional for complete information about this product and your||
0872|008|Z|specific health needs.||
0872|009|B|||
0872|010|T|TRAMADOL EXTENDED-RELEASE - ORAL||
0872|011|F|(TRAH-muh-dall)||
0872|012|B|||
0872|013|C|COMMON BRAND NAME(S): ConZip, Ryzolt, Ultram ER||
0872|014|B|||
0872|015|W|WARNING:  Tramadol has a risk for abuse and addiction, which can||
0872|016|W|lead to overdose and death. Tramadol may also cause severe,||
0872|017|W|possibly fatal, breathing problems. To lower your risk, your||
0872|018|W|doctor should have you take the smallest dose of tramadol that||
0872|019|W|works, and take it for the shortest possible time. See also How||
0872|020|W|to Use section for more information about addiction.||
0872|021|W|   Ask your doctor or pharmacist if you should have medication||
0872|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0872|023|W|Teach your family or household members about the signs of an||
0872|024|W|opioid overdose and how to treat it.||
0872|025|W|   The risk for severe breathing problems is higher when you||
0872|026|W|start this medication and after a dose increase, or if you take||
0872|027|W|the wrong dose/strength. Taking this medication with alcohol or||
0872|028|W|other drugs that can cause drowsiness or breathing problems may||
0872|029|W|cause very serious side effects, including death. Also, other||
0872|030|W|medications can affect the removal of tramadol from your body,||
0872|031|W|which may affect how tramadol works. Be sure you know how to take||
0872|032|W|tramadol and what other drugs you should avoid taking with it.||
0872|033|W|See also Drug Interactions section. Get medical help right away||
0872|034|W|if any of these very serious side effects occur: slow/shallow||
0872|035|W|breathing, unusual lightheadedness, severe drowsiness/dizziness,||
0872|036|W|difficulty waking up.||
0872|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0872|038|W|or abuse. If someone accidentally swallows this drug, get medical||
0872|039|W|help right away.||
0872|040|W|   Before using this medication, women of childbearing age should||
0872|041|W|talk with their doctor(s) about the risks and benefits. Tell your||
0872|042|W|doctor if you are pregnant or if you plan to become pregnant.||
0872|043|W|During pregnancy, this medication should be used only when||
0872|044|W|clearly needed. It may slightly increase the risk of birth||
0872|045|W|defects if used during the first two months of pregnancy. Also,||
0872|046|W|using it for a long time or in high doses near the expected||
0872|047|W|delivery date may harm the unborn baby. To lessen the risk, take||
0872|048|W|the smallest effective dose for the shortest possible time.||
0872|049|W|Babies born to mothers who use this drug for a long time may||
0872|050|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0872|051|W|doctor right away if you notice any symptoms in your newborn baby||
0872|052|W|such as crying that doesn't stop, slow/shallow breathing,||
0872|053|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0872|054|W|difficulty gaining weight.||
0872|055|W|   Children younger than 18 years should not use products that||
0872|056|W|contain tramadol. Some children are more sensitive to tramadol||
0872|057|W|and have had very serious (rarely fatal) breathing problems such||
0872|058|W|as slow/shallow breathing (see also Side Effects section). The||
0872|059|W|risk is greater in children who are obese or have breathing||
0872|060|W|problems, or after certain surgeries (including tonsil/adenoid||
0872|061|W|removal). Talk with your doctor or pharmacist about the risks and||
0872|062|W|benefits of this medication.||
0872|063|B|||
0872|064|U|USES:  See also Warning section.||
0872|065|U|   This medication is used to help relieve severe ongoing pain.||
0872|066|U|Tramadol belongs to a class of drugs known as opioid analgesics.||
0872|067|U|It works in the brain to change how your body feels and responds||
0872|068|U|to pain.||
0872|069|B|||
0872|070|H|HOW TO USE:  Read the Medication Guide provided by your||
0872|071|H|pharmacist before you start taking tramadol and each time you get||
0872|072|H|a refill. If you have any questions, ask your doctor or||
0872|073|H|pharmacist.||
0872|074|H|   Take this medication on a regular schedule as directed by your||
0872|075|H|doctor, usually once daily (every 24 hours). If you have nausea,||
0872|076|H|it may help to take this drug with food. Ask your doctor or||
0872|077|H|pharmacist about other ways to decrease nausea (such as lying||
0872|078|H|down for 1 to 2 hours with as little head movement as possible).||
0872|079|H|   Do not crush, chew, or dissolve extended-release tablets or||
0872|080|H|capsules. Doing so can release all of the drug at once,||
0872|081|H|increasing the risk of side effects or overdose. Swallow whole||
0872|082|H|without crushing or chewing.||
0872|083|H|   The dosage is based on your medical condition and response to||
0872|084|H|treatment. To reduce your risk of side effects, your doctor may||
0872|085|H|direct you to start this medication at a low dose and gradually||
0872|086|H|increase your dose. Follow your doctor's instructions carefully.||
0872|087|H|Do not increase your dose, take the medication more often, or||
0872|088|H|take it for a longer time than prescribed. Properly stop the||
0872|089|H|medication when so directed.||
0872|090|H|   Before you start using this medication, ask your doctor or||
0872|091|H|pharmacist if you should stop or change how you use your other||
0872|092|H|opioid medication(s). Other pain relievers (such as||
0872|093|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
0872|094|H|or pharmacist about using tramadol safely with other drugs.||
0872|095|H|   Suddenly stopping this medication may cause withdrawal,||
0872|096|H|especially if you have used it for a long time or in high doses.||
0872|097|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0872|098|H|Tell your doctor or pharmacist right away if you have any||
0872|099|H|withdrawal symptoms such as restlessness, mental/mood changes||
0872|100|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0872|101|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0872|102|H|aches, or sudden changes in behavior.||
0872|103|H|   When this medication is used for a long time, it may not work||
0872|104|H|as well. Talk with your doctor if this medication stops working||
0872|105|H|well.||
0872|106|H|   Though it helps many people, this medication may sometimes||
0872|107|H|cause addiction. This risk may be higher if you have a||
0872|108|H|mental/mood disorder or a substance use disorder (such as overuse||
0872|109|H|of or addiction to drugs/alcohol). Take this medication exactly||
0872|110|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0872|111|H|pharmacist for more details.||
0872|112|H|   Tell your doctor if your pain does not get better or if it||
0872|113|H|gets worse, or if you have any new pain.||
0872|114|B|||
0872|115|S|SIDE EFFECTS:  See also Warning section.||
0872|116|S|   Nausea, vomiting, constipation, sweating, trouble sleeping,||
0872|117|S|dry mouth, tiredness, lightheadedness, dizziness, drowsiness, or||
0872|118|S|headache may occur. Some of these side effects may decrease after||
0872|119|S|you have been using this medication for a while. If any of these||
0872|120|S|effects last or get worse, tell your doctor or pharmacist||
0872|121|S|promptly.||
0872|122|S|   To prevent constipation, eat dietary fiber, drink enough||
0872|123|S|water, and exercise. You may also need to take a laxative. Ask||
0872|124|S|your pharmacist which type of laxative is right for you.||
0872|125|S|   To reduce the risk of dizziness and lightheadedness, get up||
0872|126|S|slowly when rising from a sitting or lying position.||
0872|127|S|   Remember that this medication has been prescribed because your||
0872|128|S|doctor has judged that the benefit to you is greater than the||
0872|129|S|risk of side effects. Many people using this medication do not||
0872|130|S|have serious side effects.||
0872|131|S|   Tell your doctor right away if you have any serious side||
0872|132|S|effects, including: interrupted breathing during sleep (sleep||
0872|133|S|apnea), mental/mood changes (such as agitation, hallucinations),||
0872|134|S|severe stomach/abdominal pain, difficulty urinating, signs of||
0872|135|S|your adrenal glands not working well (such as loss of appetite,||
0872|136|S|unusual tiredness, weight loss), trouble swallowing.||
0872|137|S|   Get medical help right away if you have any very serious side||
0872|138|S|effects, including: fast/irregular heartbeat, severe dizziness,||
0872|139|S|fainting, seizure.||
0872|140|S|   This medication may increase serotonin and rarely cause a very||
0872|141|S|serious condition called serotonin syndrome/toxicity. The risk||
0872|142|S|increases if you are also taking other drugs that increase||
0872|143|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0872|144|S|take (see Drug Interactions section). Get medical help right away||
0872|145|S|if you develop some of the following symptoms: fast heartbeat,||
0872|146|S|hallucinations, loss of coordination, severe dizziness, severe||
0872|147|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0872|148|S|unusual agitation/restlessness.||
0872|149|S|   Tramadol is changed into a strong opioid drug in your body. In||
0872|150|S|some people, this change happens faster and more completely than||
0872|151|S|usual, which increases the risk of very serious side effects. Get||
0872|152|S|medical help right away if you notice any of the following:||
0872|153|S|slow/shallow breathing, severe drowsiness/difficulty waking up,||
0872|154|S|confusion.||
0872|155|S|   A very serious allergic reaction to this drug is rare.||
0872|156|S|However, get medical help right away if you notice any of the||
0872|157|S|following symptoms: rash, itching/swelling (especially of the||
0872|158|S|face/tongue/throat), severe dizziness, trouble breathing.||
0872|159|S|   This is not a complete list of possible side effects. If you||
0872|160|S|notice other effects not listed above, contact your doctor or||
0872|161|S|pharmacist.||
0872|162|S|   In the US -||
0872|163|S|   Call your doctor for medical advice about side effects. You||
0872|164|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0872|165|S|www.fda.gov/medwatch.||
0872|166|S|   In Canada - Call your doctor for medical advice about side||
0872|167|S|effects. You may report side effects to Health Canada at||
0872|168|S|1-866-234-2345.||
0872|169|B|||
0872|170|P|PRECAUTIONS:  Before taking tramadol, tell your doctor or||
0872|171|P|pharmacist if you are allergic to it; or if you have any other||
0872|172|P|allergies. This product may contain inactive ingredients, which||
0872|173|P|can cause allergic reactions or other problems. Talk to your||
0872|174|P|pharmacist for more details.||
0872|175|P|   Before using this medication, tell your doctor or pharmacist||
0872|176|P|your medical history, especially of: brain disorders (such as||
0872|177|P|head injury, tumor, seizures), breathing problems (such as||
0872|178|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0872|179|P|kidney disease, liver disease, diabetes, mental/mood disorders||
0872|180|P|(such as confusion, depression, suicidal thoughts), personal or||
0872|181|P|family history of a substance use disorder (such as overuse of or||
0872|182|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
0872|183|P|blockage, constipation, diarrhea due to infection, paralytic||
0872|184|P|ileus), difficulty urinating (such as due to enlarged prostate),||
0872|185|P|gallbladder disease, disease of the pancreas (pancreatitis),||
0872|186|P|obesity.||
0872|187|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0872|188|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0872|189|P|machinery, or do anything that needs alertness until you can do||
0872|190|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0872|191|P|are using marijuana (cannabis).||
0872|192|P|   Tramadol may cause a condition that affects the heart rhythm||
0872|193|P|(QT prolongation). QT prolongation can rarely cause serious||
0872|194|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0872|195|P|as severe dizziness, fainting) that need medical attention right||
0872|196|P|away.||
0872|197|P|   The risk of QT prolongation may be increased if you have||
0872|198|P|certain medical conditions or are taking other drugs that may||
0872|199|P|cause QT prolongation. Before using tramadol, tell your doctor or||
0872|200|P|pharmacist of all the drugs you take and if you have any of the||
0872|201|P|following conditions: certain heart problems (heart failure, slow||
0872|202|P|heartbeat, QT prolongation in the EKG), family history of certain||
0872|203|P|heart problems (QT prolongation in the EKG, sudden cardiac||
0872|204|P|death).||
0872|205|P|   Low levels of potassium or magnesium in the blood may also||
0872|206|P|increase your risk of QT prolongation. This risk may increase if||
0872|207|P|you use certain drugs (such as diuretics/"water pills") or if you||
0872|208|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0872|209|P|Talk to your doctor about using tramadol safely.||
0872|210|P|   Before having surgery, tell your doctor or dentist about all||
0872|211|P|the products you use (including prescription drugs,||
0872|212|P|nonprescription drugs, and herbal products).||
0872|213|P|   Some children may be more sensitive to very serious side||
0872|214|P|effects of tramadol, such as extreme sleepiness, confusion, or||
0872|215|P|slow/shallow/noisy breathing. (See also Warning section.)||
0872|216|P|   Older adults may be more sensitive to the side effects of this||
0872|217|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
0872|218|P|breathing, and QT prolongation (see above). Older adults may also||
0872|219|P|be more likely to develop a type of salt imbalance (hyponatremia)||
0872|220|P|while using this drug.||
0872|221|P|   During pregnancy, this medication should be used only when||
0872|222|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0872|223|P|benefits with your doctor. (See also Warning section.)||
0872|224|P|   This medication passes into breast milk and may have||
0872|225|P|undesirable effects on a nursing infant (such as unusual||
0872|226|P|sleepiness, difficulty feeding, or trouble breathing).||
0872|227|P|Breastfeeding is not recommended while using this medication.||
0872|228|P|Consult your doctor before breastfeeding.||
0872|229|B|||
0872|230|I|DRUG INTERACTIONS:  See also Warning section.||
0872|231|I|   Drug interactions may change how your medications work or||
0872|232|I|increase your risk for serious side effects. This document does||
0872|233|I|not contain all possible drug interactions. Keep a list of all||
0872|234|I|the products you use (including prescription/nonprescription||
0872|235|I|drugs and herbal products) and share it with your doctor and||
0872|236|I|pharmacist. Do not start, stop, or change the dosage of any||
0872|237|I|medicines without your doctor's approval.||
0872|238|I|   Some products that may interact with this drug include:||
0872|239|I|certain pain medications (mixed opioid agonist-antagonists such||
0872|240|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0872|241|I|samidorphan.||
0872|242|I|   Taking MAO inhibitors with this medication may cause a serious||
0872|243|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0872|244|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0872|245|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0872|246|I|selegiline, tranylcypromine) during treatment with this||
0872|247|I|medication. Most MAO inhibitors should also not be taken for two||
0872|248|I|weeks before treatment with this medication. Ask your doctor when||
0872|249|I|to start or stop taking this medication.||
0872|250|I|   The risk of serotonin syndrome/toxicity increases if you are||
0872|251|I|also taking other drugs that increase serotonin. Examples include||
0872|252|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
0872|253|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0872|254|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0872|255|I|serotonin syndrome/toxicity may be more likely when you start or||
0872|256|I|increase the dose of these drugs.||
0872|257|I|   Other medications can affect the removal of tramadol from your||
0872|258|I|body, which may affect how tramadol works. Examples include azole||
0872|259|I|antifungals (such as itraconazole), macrolide antibiotics (such||
0872|260|I|as erythromycin), quinidine, rifamycins (such as rifampin),||
0872|261|I|ritonavir, drugs used to treat seizures (such as carbamazepine),||
0872|262|I|among others.||
0872|263|I|   The risk of serious side effects (such as slow/shallow||
0872|264|I|breathing, severe drowsiness/dizziness) may be increased if this||
0872|265|I|medication is taken with other products that may also cause||
0872|266|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0872|267|I|if you are taking other products such as other opioid pain or||
0872|268|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0872|269|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0872|270|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0872|271|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0872|272|I|cetirizine, diphenhydramine).||
0872|273|I|   Check the labels on all your medicines (such as allergy or||
0872|274|I|cough-and-cold products) because they may contain ingredients||
0872|275|I|that cause drowsiness. Ask your pharmacist about using those||
0872|276|I|products safely.||
0872|277|I|   This medication may interfere with certain lab tests (such as||
0872|278|I|amylase/lipase levels), possibly causing false test results. Make||
0872|279|I|sure lab personnel and all your doctors know you use this drug.||
0872|280|B|||
0872|281|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0872|282|O|as passing out or trouble breathing, give them naloxone or||
0872|283|O|nalmefene if available, then call 911. If the person is awake and||
0872|284|O|has no symptoms, call a poison control center right away. US||
0872|285|O|residents can call 1-800-222-1222. Canada residents can call||
0872|286|O|1-844-764-7669. Symptoms of overdose may include: slow breathing,||
0872|287|O|slow/irregular heartbeat, coma, seizure.||
0872|288|B|||
0872|289|N|NOTES:  Do not share this medication with others. Sharing it is||
0872|290|N|against the law.||
0872|291|N|   This medication has been prescribed for your current condition||
0872|292|N|only. Do not use it later for another condition unless told to do||
0872|293|N|so by your doctor. A different medication may be necessary in||
0872|294|N|that case.||
0872|295|B|||
0872|296|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0872|297|D|remember. If it is near the time of the next dose, skip the||
0872|298|D|missed dose. Take your next dose at the regular time. Do not||
0872|299|D|double the dose to catch up.||
0872|300|B|||
0872|301|R|STORAGE:  Store at room temperature away from moisture. Keep all||
0872|302|R|medications away from children and pets.||
0872|303|R|   Do not flush medications down the toilet or pour them into a||
0872|304|R|drain unless instructed to do so. Properly discard this product||
0872|305|R|when it is expired or no longer needed. Consult your pharmacist||
0872|306|R|or local waste disposal company.||
0872|307|B|||
0872|308|A|Information last revised August 2025.||
0872|309|A|Copyright(c) 2025 First Databank, Inc.||
0872|310|B|||
0873|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0873|002|Z|does NOT have all possible information about this product. This||
0873|003|Z|information does not assure that this product is safe, effective,||
0873|004|Z|or appropriate for you. This information is not individual||
0873|005|Z|medical advice and does not substitute for the advice of your||
0873|006|Z|health care professional. Always ask your health care||
0873|007|Z|professional for complete information about this product and your||
0873|008|Z|specific health needs.||
0873|009|B|||
0873|010|T|PHENYLEPHRINE HEMORRHOIDAL SUPPOSITORY - RECTAL||
0873|011|F|(FEN-il-EF-rin)||
0873|012|B|||
0873|013|C|COMMON BRAND NAME(S): Anu-med||
0873|014|B|||
0873|015|U|USES:  This medication is used to temporarily relieve swelling,||
0873|016|U|burning, pain, and itching caused by hemorrhoids. It contains||
0873|017|U|phenylephrine, which belongs to a class of drugs known as||
0873|018|U|sympathomimetic amines. It works by temporarily narrowing the||
0873|019|U|blood vessels in the area. This effect decreases swelling and||
0873|020|U|discomfort.||
0873|021|U|   Some products may also contain substances (such as cocoa||
0873|022|U|butter, hard fat, mineral oil, shark liver oil) that form a||
0873|023|U|protective barrier to prevent too much irritating contact with||
0873|024|U|stool.||
0873|025|U|   Do not use this product in children 12 years or younger||
0873|026|U|without talking with the doctor.||
0873|027|B|||
0873|028|H|HOW TO USE:  Follow all directions on the product package. If you||
0873|029|H|have any questions, ask your doctor or pharmacist.||
0873|030|H|   Before use, clean the area with mild soap and water, rinse||
0873|031|H|well, and pat dry.||
0873|032|H|   Use this product in the rectum only. This product is generally||
0873|033|H|used up to 4 times a day, usually one in the morning and one in||
0873|034|H|the evening, and after each bowel movement or as directed by your||
0873|035|H|doctor.||
0873|036|H|   Unwrap the suppository and moisten it with a few drops of||
0873|037|H|water to soften it. Lie on your left side with the right knee||
0873|038|H|bent. Carefully push the suppository (pointed end first) just||
0873|039|H|inside the rectum with your finger. Remain lying down for a few||
0873|040|H|minutes, and avoid having a bowel movement for at least 1 hour.||
0873|041|H|   Dosage is based on your medical condition and response to||
0873|042|H|treatment. Do not use more often or for a longer time than||
0873|043|H|directed.||
0873|044|H|   Tell your doctor if your symptoms do not get better within 7||
0873|045|H|days or if bleeding/worsening pain occurs. If you think you may||
0873|046|H|have a serious medical problem, get medical help right away.||
0873|047|B|||
0873|048|S|SIDE EFFECTS:  This medication does not usually have bothersome||
0873|049|S|side effects when used as directed. Mild pain/stinging may occur||
0873|050|S|if the rectal tissue is raw or bleeding. If any of these effects||
0873|051|S|last or get worse, tell your doctor or pharmacist promptly.||
0873|052|S|   If your doctor has directed you to use this medication,||
0873|053|S|remember that your doctor has judged that the benefit to you is||
0873|054|S|greater than the risk of side effects. Many people using this||
0873|055|S|medication do not have serious side effects.||
0873|056|S|   Stop using this medication and tell your doctor right away if||
0873|057|S|you have any serious side effects, including: fast/irregular||
0873|058|S|heartbeat, pounding headache, nervousness, shakiness (tremor),||
0873|059|S|trouble sleeping.||
0873|060|S|   A very serious allergic reaction to this drug is rare.||
0873|061|S|However, get medical help right away if you notice any symptoms||
0873|062|S|of a serious allergic reaction, including: rash, itching/swelling||
0873|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0873|064|S|breathing.||
0873|065|S|   This is not a complete list of possible side effects. If you||
0873|066|S|notice other effects not listed above, contact your doctor or||
0873|067|S|pharmacist.||
0873|068|S|   In the US -||
0873|069|S|   Call your doctor for medical advice about side effects. You||
0873|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0873|071|S|www.fda.gov/medwatch.||
0873|072|S|   In Canada - Call your doctor for medical advice about side||
0873|073|S|effects. You may report side effects to Health Canada at||
0873|074|S|1-866-234-2345.||
0873|075|B|||
0873|076|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0873|077|P|pharmacist if you are allergic to it; or to any of its||
0873|078|P|ingredients; or if you have any other allergies. This product may||
0873|079|P|contain inactive ingredients, which can cause allergic reactions||
0873|080|P|or other problems. Talk to your pharmacist for more details.||
0873|081|P|   If you have any of the following health problems, consult your||
0873|082|P|doctor or pharmacist before using this product: diabetes, heart||
0873|083|P|problems (such as chest pain, heart attack), high blood pressure,||
0873|084|P|overactive thyroid (hyperthyroidism), difficult urination due to||
0873|085|P|blockage (for example, due to an enlarged prostate).||
0873|086|P|   Before having surgery, tell your doctor or dentist about all||
0873|087|P|the products you use (including prescription drugs,||
0873|088|P|nonprescription drugs, and herbal products).||
0873|089|P|   During pregnancy, this medication should be used only when||
0873|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
0873|091|P|   It is unknown if this drug passes into breast milk. Consult||
0873|092|P|your doctor before breastfeeding.||
0873|093|B|||
0873|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0873|095|I|medications work or increase your risk for serious side effects.||
0873|096|I|This document does not contain all possible drug interactions.||
0873|097|I|Keep a list of all the products you use (including||
0873|098|I|prescription/nonprescription drugs and herbal products) and share||
0873|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
0873|100|I|the dosage of any medicines without your doctor's approval.||
0873|101|B|||
0873|102|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0873|103|O|has overdosed and has serious symptoms such as passing out or||
0873|104|O|trouble breathing, call 911. Otherwise, call a poison control||
0873|105|O|center right away. US residents can call 1-800-222-1222. Canada||
0873|106|O|residents can call 1-844-764-7669.||
0873|107|B|||
0873|108|N|NOTES:  To maintain normal bowel function and reduce the risk of||
0873|109|N|hemorrhoids, eat a proper diet high in fiber, drink 6 to 8||
0873|110|N|glasses of water each day, and exercise regularly.||
0873|111|B|||
0873|112|D|MISSED DOSE:  If you are using this product on a regular schedule||
0873|113|D|and miss a dose, use it as soon as you remember. If it is near||
0873|114|D|the time of the next dose, skip the missed dose. Use your next||
0873|115|D|dose at the regular time. Do not double the dose to catch up.||
0873|116|B|||
0873|117|R|STORAGE:  Store at room temperature. Different brands of this||
0873|118|R|medication may have different storage needs. Check the product||
0873|119|R|package for instructions on how to store your brand, or ask your||
0873|120|R|pharmacist. Keep all medications away from children and pets.||
0873|121|R|   Do not flush medications down the toilet or pour them into a||
0873|122|R|drain unless instructed to do so. Properly discard this product||
0873|123|R|when it is expired or no longer needed. Consult your pharmacist||
0873|124|R|or local waste disposal company.||
0873|125|B|||
0873|126|A|Information last revised June 2025.||
0873|127|A|Copyright(c) 2025 First Databank, Inc.||
0873|128|B|||
0875|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0875|002|Z|does NOT have all possible information about this product. This||
0875|003|Z|information does not assure that this product is safe, effective,||
0875|004|Z|or appropriate for you. This information is not individual||
0875|005|Z|medical advice and does not substitute for the advice of your||
0875|006|Z|health care professional. Always ask your health care||
0875|007|Z|professional for complete information about this product and your||
0875|008|Z|specific health needs.||
0875|009|B|||
0875|010|T|CICLESONIDE HFA INHALER - ORAL INHALATION||
0875|011|F|(sye-KLES-oh-nide)||
0875|012|B|||
0875|013|C|COMMON BRAND NAME(S): Alvesco||
0875|014|B|||
0875|015|U|USES:  Ciclesonide is used to prevent and reduce the symptoms||
0875|016|U|(wheezing and shortness of breath) caused by asthma. Controlling||
0875|017|U|asthma symptoms may decrease time lost from work or school. This||
0875|018|U|medication belongs to a class of drugs known as corticosteroids.||
0875|019|U|It works by reducing the swelling of the airways in the lungs to||
0875|020|U|make breathing easier.||
0875|021|U|   This medication must be taken regularly to be effective. It||
0875|022|U|does not work right away and should not be used to relieve sudden||
0875|023|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
0875|024|U|inhaler as prescribed. Keep track of how often you need to use||
0875|025|U|your quick-relief inhaler, and tell your doctor. If your||
0875|026|U|quick-relief inhaler does not seem to work as well, if you need||
0875|027|U|to use more than usual of your quick-relief inhaler for 2 or more||
0875|028|U|days in a row, or if you need to use more than one full canister||
0875|029|U|of your quick-relief inhaler over a 2-month period, get medical||
0875|030|U|help right away.||
0875|031|B|||
0875|032|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0875|033|H|your pharmacist before you start using ciclesonide and each time||
0875|034|H|you get a refill. If you have any questions, ask your doctor or||
0875|035|H|pharmacist.||
0875|036|H|   Inhale this medication by mouth as directed by your doctor. No||
0875|037|H|shaking of the inhaler is necessary before use. If the inhaler is||
0875|038|H|new or has not been used for 1 week or more, prime the inhaler||
0875|039|H|for use by spraying 3 puffs into the air. Remove the cover on the||
0875|040|H|mouthpiece. Breathe out as much as you comfortably can. Place the||
0875|041|H|mouthpiece into your mouth and close your lips tightly around it.||
0875|042|H|While breathing in slowly and deeply, press down on the canister||
0875|043|H|with your finger. After inhaling, try to hold your breath for at||
0875|044|H|least 10 seconds to get this medication into your lungs and allow||
0875|045|H|it to work properly.||
0875|046|H|   Dosage is based on your medical condition and response to||
0875|047|H|treatment.||
0875|048|H|   A spacer device may be used with this medication if you find||
0875|049|H|it difficult to use this inhaler. Ask your doctor or pharmacist||
0875|050|H|for more information.||
0875|051|H|   If your prescribed dose is 2 puffs, wait at least one minute||
0875|052|H|between them. If you are using other inhalers at the same time,||
0875|053|H|wait at least 1 minute between the use of each medication, and||
0875|054|H|use this drug (the corticosteroid) last.||
0875|055|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
0875|056|H|from developing, gargle, rinse your mouth with water and spit out||
0875|057|H|after each use. Do not swallow the rinse water.||
0875|058|H|   Clean the mouthpiece once a week with a dry tissue. Do not wet||
0875|059|H|the mouthpiece to clean it.||
0875|060|H|   Use this medication regularly to get the most benefit from it.||
0875|061|H|This medication works best when used at evenly spaced intervals.||
0875|062|H|To help you remember, use it at the same time each day. Do not||
0875|063|H|increase your dose, use this inhaler more often, or stop using it||
0875|064|H|without first consulting your doctor.||
0875|065|H|   Learn which of your inhalers you should use every day||
0875|066|H|(controller drugs) and which you should use if your breathing||
0875|067|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
0875|068|H|time what you should do if you have new or worsening cough or||
0875|069|H|shortness of breath, wheezing, increased sputum, worsening peak||
0875|070|H|flow meter readings, waking up at night with trouble breathing,||
0875|071|H|if you use your quick-relief inhaler more often (more than 2 days||
0875|072|H|a week), or if your quick-relief inhaler does not seem to be||
0875|073|H|working well. Learn when you can treat sudden breathing problems||
0875|074|H|by yourself and when you must get medical help right away.||
0875|075|H|   You may begin to feel this medication working within 24 hours,||
0875|076|H|but it may take several weeks or longer before the full benefit||
0875|077|H|of this drug takes effect. Tell your doctor if your symptoms do||
0875|078|H|not get better or if they get worse.||
0875|079|B|||
0875|080|S|SIDE EFFECTS:  See also Precautions section.||
0875|081|S|   Dry/irritated throat, hoarseness, a bad taste in the mouth, or||
0875|082|S|coughing may occur. If any of these effects last or get worse,||
0875|083|S|tell your doctor or pharmacist promptly.||
0875|084|S|   Remember that this medication has been prescribed because your||
0875|085|S|doctor has judged that the benefit to you is greater than the||
0875|086|S|risk of side effects. Many people using this medication do not||
0875|087|S|have serious side effects.||
0875|088|S|   Tell your doctor right away if you have any serious side||
0875|089|S|effects, including: white patches in your mouth or on your||
0875|090|S|tongue, headache that doesn't go away, vision changes, poor wound||
0875|091|S|healing, puffy face, unexpected weight gain, muscle||
0875|092|S|pain/weakness, mental/mood changes (such as depression,||
0875|093|S|agitation), increased thirst/urination.||
0875|094|S|   Rarely, this medication may cause severe sudden worsening of||
0875|095|S|breathing problems/asthma immediately after use. If you have||
0875|096|S|sudden worsening of breathing, use your quick-relief inhaler and||
0875|097|S|get medical help right away.||
0875|098|S|   A very serious allergic reaction to this drug is rare.||
0875|099|S|However, get medical help right away if you notice any symptoms||
0875|100|S|of a serious allergic reaction, including: rash, itching/swelling||
0875|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0875|102|S|breathing.||
0875|103|S|   This is not a complete list of possible side effects. If you||
0875|104|S|notice other effects not listed above, contact your doctor or||
0875|105|S|pharmacist.||
0875|106|S|   In the US -||
0875|107|S|   Call your doctor for medical advice about side effects. You||
0875|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0875|109|S|www.fda.gov/medwatch.||
0875|110|S|   In Canada - Call your doctor for medical advice about side||
0875|111|S|effects. You may report side effects to Health Canada at||
0875|112|S|1-866-234-2345.||
0875|113|B|||
0875|114|P|PRECAUTIONS:  Before using ciclesonide, tell your doctor or||
0875|115|P|pharmacist if you are allergic to it; or to other corticosteroids||
0875|116|P|(such as beclomethasone, fluticasone); or if you have any other||
0875|117|P|allergies. This product may contain inactive ingredients, which||
0875|118|P|can cause allergic reactions or other problems. Talk to your||
0875|119|P|pharmacist for more details.||
0875|120|P|   Before using this medication, tell your doctor or pharmacist||
0875|121|P|your medical history, especially of: tuberculosis, untreated||
0875|122|P|infections (such as those caused by fungus or bacteria), certain||
0875|123|P|eye problems (glaucoma, cataracts, herpes infection of the eye),||
0875|124|P|liver disease, adrenal gland problems (such as adrenal||
0875|125|P|insufficiency), underactive thyroid (hypothyroidism), bone loss||
0875|126|P|(osteoporosis).||
0875|127|P|   If you have switched from a corticosteroid taken by mouth||
0875|128|P|(such as prednisone tablets) to this inhaler within the past 12||
0875|129|P|months, or if you have been using this product in||
0875|130|P|higher-than-usual doses for a long time, it may be more difficult||
0875|131|P|for your body to respond to physical stress. Before having||
0875|132|P|surgery or emergency treatment, or if you get a serious||
0875|133|P|illness/injury, tell your doctor or dentist that you are using||
0875|134|P|this medication or have used a corticosteroid taken by mouth||
0875|135|P|within the past 12 months. Tell your doctor right away if you||
0875|136|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
0875|137|P|card or medical ID bracelet that says you use (or have used)||
0875|138|P|corticosteroid medications.||
0875|139|P|   This medication may mask signs of infection. It can make you||
0875|140|P|more likely to get infections or may make current infections||
0875|141|P|worse. Stay away from anyone who has an infection that may easily||
0875|142|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0875|143|P|doctor if you have been exposed to an infection or for more||
0875|144|P|details.||
0875|145|P|   When used for extended periods, medications similar to||
0875|146|P|ciclesonide may affect bone strength, especially in people who||
0875|147|P|smoke, have a family history of brittle bones (osteoporosis), or||
0875|148|P|take other medications that may weaken bones (such as phenytoin).||
0875|149|P|Bone density tests may help to determine whether you need||
0875|150|P|medication to treat or prevent this problem. Consult your doctor||
0875|151|P|for more information.||
0875|152|P|   This medication may temporarily slow down a child's growth if||
0875|153|P|used for a long time. However, poorly controlled asthma can also||
0875|154|P|slow down growth. See the doctor regularly so your child's height||
0875|155|P|can be checked.||
0875|156|P|   During pregnancy, this medication should be used only when||
0875|157|P|clearly needed. Discuss the risks and benefits with your doctor.||
0875|158|P|   It is unknown if this drug passes into breast milk. Consult||
0875|159|P|your doctor before breastfeeding.||
0875|160|B|||
0875|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0875|162|I|medications work or increase your risk for serious side effects.||
0875|163|I|This document does not contain all possible drug interactions.||
0875|164|I|Keep a list of all the products you use (including||
0875|165|I|prescription/nonprescription drugs and herbal products) and share||
0875|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
0875|167|I|the dosage of any medicines without your doctor's approval.||
0875|168|I|   Some products that may interact with this drug are:||
0875|169|I|aldesleukin, desmopressin, corticosteroids taken by mouth (such||
0875|170|I|as prednisone, dexamethasone), mifepristone.||
0875|171|I|   Other medications can affect the removal of ciclesonide from||
0875|172|I|your body, which may affect how ciclesonide works. Examples||
0875|173|I|include some azole antifungals (such as ketoconazole), HIV||
0875|174|I|protease inhibitors (such as nelfinavir), ritonavir, among||
0875|175|I|others.||
0875|176|B|||
0875|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0875|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0875|179|O|poison control center right away. US residents can call||
0875|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0875|181|B|||
0875|182|N|NOTES:  Do not share this medication with others.||
0875|183|N|   Lab and/or medical tests (such as morning cortisol levels, eye||
0875|184|N|exams, bone density tests) may be done while you are using this||
0875|185|N|medication. Keep all medical and lab appointments. Consult your||
0875|186|N|doctor for more details.||
0875|187|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
0875|188|N|mold that can worsen breathing problems. Because the flu virus||
0875|189|N|can also worsen breathing problems, ask your doctor or pharmacist||
0875|190|N|if you should have a flu shot every year.||
0875|191|N|   This medication may cause bone loss (osteoporosis) in adults||
0875|192|N|when used for a long time. Lifestyle changes that may help reduce||
0875|193|N|the risk of bone problems include doing weight-bearing exercise,||
0875|194|N|stopping smoking, limiting alcohol, and getting enough calcium||
0875|195|N|and vitamin D. Talk to your doctor for more details.||
0875|196|B|||
0875|197|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0875|198|D|If it is near the time of the next dose, skip the missed dose.||
0875|199|D|Use your next dose at the regular time. Do not double the dose to||
0875|200|D|catch up.||
0875|201|B|||
0875|202|R|STORAGE:  Store at room temperature away from heat. Do not||
0875|203|R|freeze. Do not puncture the canister or use near an open flame.||
0875|204|R|Keep all medications away from children and pets.||
0875|205|R|   Do not flush medications down the toilet or pour them into a||
0875|206|R|drain unless instructed to do so. Properly discard this product||
0875|207|R|when it is expired or no longer needed. Consult your pharmacist||
0875|208|R|or local waste disposal company.||
0875|209|B|||
0875|210|M|MEDICAL ALERT:  Your condition can cause complications in a||
0875|211|M|medical emergency. For information about enrolling in MedicAlert,||
0875|212|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0875|213|B|||
0875|214|A|Information last revised September 2025.||
0875|215|A|Copyright(c) 2025 First Databank, Inc.||
0875|216|B|||
0876|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0876|002|Z|does NOT have all possible information about this product. This||
0876|003|Z|information does not assure that this product is safe, effective,||
0876|004|Z|or appropriate for you. This information is not individual||
0876|005|Z|medical advice and does not substitute for the advice of your||
0876|006|Z|health care professional. Always ask your health care||
0876|007|Z|professional for complete information about this product and your||
0876|008|Z|specific health needs.||
0876|009|B|||
0876|010|T|ARIPIPRAZOLE EXTENDED-RELEASE - INJECTION||
0876|011|F|(AR-i-PIP-ra-zole)||
0876|012|B|||
0876|013|C|COMMON BRAND NAME(S): Abilify Asimtufii, Abilify Maintena,||
0876|014|C|Aristada||
0876|015|B|||
0876|016|W|WARNING:  There may be a slightly increased risk of serious,||
0876|017|W|possibly fatal side effects (such as stroke, heart failure,||
0876|018|W|fast/irregular heartbeat, pneumonia) when this medication is used||
0876|019|W|by older adults with dementia. This medication is not approved||
0876|020|W|for the treatment of dementia-related behavior problems. Discuss||
0876|021|W|the risks and benefits of this medication, as well as other||
0876|022|W|effective and possibly safer treatments for dementia-related||
0876|023|W|behavior problems, with the doctor.||
0876|024|B|||
0876|025|U|USES:  This medication is used to treat a certain mental/mood||
0876|026|U|disorder (schizophrenia). Some brands of this medication are also||
0876|027|U|used to treat bipolar disorder. Extended-release aripiprazole||
0876|028|U|injection is a long-acting form of aripiprazole. Aripiprazole||
0876|029|U|belongs to a class of drugs known as atypical antipsychotics. It||
0876|030|U|works by helping to restore the balance of certain natural||
0876|031|U|substances in the brain.||
0876|032|B|||
0876|033|H|HOW TO USE:  Read the Medication Guide provided by your||
0876|034|H|pharmacist before you start using aripiprazole and each time you||
0876|035|H|get a refill. If you have any questions, ask your doctor or||
0876|036|H|pharmacist.||
0876|037|H|   The extended-release injection should only be used if you have||
0876|038|H|already taken aripiprazole by mouth without any serious side||
0876|039|H|effects.||
0876|040|H|   Depending on your brand, this medication is given by injection||
0876|041|H|into the buttock or upper arm muscle by a health care||
0876|042|H|professional. Some brands may only be given by injection into the||
0876|043|H|buttock muscle. It is given as directed by your doctor, usually||
0876|044|H|once every month. Some doses may be given once every 6 weeks or||
0876|045|H|once every 2 months. Do not rub/massage the injection site after||
0876|046|H|your dose.||
0876|047|H|   After your first injection, your doctor may direct you to||
0876|048|H|continue to take your antipsychotic medication by mouth (such as||
0876|049|H|aripiprazole tablet/solution) for 2 to 3 weeks. This will help||
0876|050|H|maintain the right level of medication in your body as you switch||
0876|051|H|from receiving medication by mouth to receiving it by injection.||
0876|052|H|Follow your doctor's instructions carefully.||
0876|053|H|   The dosage is based on your medical condition, response to||
0876|054|H|treatment, and other medications you may be taking. Be sure to||
0876|055|H|tell your doctor and pharmacist about all the products you use||
0876|056|H|(including prescription drugs, nonprescription drugs, and herbal||
0876|057|H|products).||
0876|058|H|   It may take several weeks to get the full benefit of this||
0876|059|H|medication. Use this medication regularly to get the most benefit||
0876|060|H|from it. To help you remember, mark your calendar with a||
0876|061|H|reminder.||
0876|062|H|   Tell your doctor if your condition does not get better or if||
0876|063|H|it gets worse.||
0876|064|B|||
0876|065|S|SIDE EFFECTS:  See also Warning section.||
0876|066|S|   Dizziness, lightheadedness, drowsiness, tiredness, blurred||
0876|067|S|vision, weight gain, shaking (tremors), and redness/pain/swelling||
0876|068|S|at the injection site may occur. If any of these effects last or||
0876|069|S|get worse, tell your doctor or pharmacist promptly.||
0876|070|S|   Dizziness and lightheadedness can increase the risk of||
0876|071|S|falling. Get up slowly when rising from a sitting or lying||
0876|072|S|position.||
0876|073|S|   Remember that this medication has been prescribed because your||
0876|074|S|doctor has judged that the benefit to you is greater than the||
0876|075|S|risk of side effects. Many people using this medication do not||
0876|076|S|have serious side effects.||
0876|077|S|   Tell your doctor right away if you have any serious side||
0876|078|S|effects, including: fainting, trouble swallowing, restlessness||
0876|079|S|(especially in the legs), seizures, trouble controlling certain||
0876|080|S|urges (such as gambling, sex, eating or shopping), interrupted||
0876|081|S|breathing during sleep.||
0876|082|S|   This medication may rarely make your blood sugar rise, which||
0876|083|S|can cause or worsen diabetes. Tell your doctor right away if you||
0876|084|S|have symptoms of high blood sugar such as increased||
0876|085|S|thirst/urination. If you already have diabetes, check your blood||
0876|086|S|sugar regularly as directed and share the results with your||
0876|087|S|doctor. Your doctor may need to adjust your diabetes medication,||
0876|088|S|exercise program, or diet.||
0876|089|S|   This medication may rarely cause a condition known as tardive||
0876|090|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0876|091|S|your doctor right away if you develop any unusual uncontrolled||
0876|092|S|movements (especially of the face, mouth, tongue, arms, or legs).||
0876|093|S|   This medication may rarely cause a serious condition called||
0876|094|S|neuroleptic malignant syndrome (NMS). Get medical help right away||
0876|095|S|if you develop any of the following: fever, muscle||
0876|096|S|cramps/stiffness/pain/tenderness/weakness, severe tiredness,||
0876|097|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
0876|098|S|signs of kidney problems (such as change in the amount of urine).||
0876|099|S|   A very serious allergic reaction to this drug is rare.||
0876|100|S|However, get medical help right away if you notice any symptoms||
0876|101|S|of a serious allergic reaction, including: fever, swollen lymph||
0876|102|S|nodes, rash, itching/swelling (especially of the||
0876|103|S|face/tongue/throat), severe dizziness, trouble breathing.||
0876|104|S|   This is not a complete list of possible side effects. If you||
0876|105|S|notice other effects not listed above, contact your doctor or||
0876|106|S|pharmacist.||
0876|107|S|   In the US -||
0876|108|S|   Call your doctor for medical advice about side effects. You||
0876|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0876|110|S|www.fda.gov/medwatch.||
0876|111|S|   In Canada - Call your doctor for medical advice about side||
0876|112|S|effects. You may report side effects to Health Canada at||
0876|113|S|1-866-234-2345.||
0876|114|B|||
0876|115|P|PRECAUTIONS:  See also Warning and Side Effects sections.||
0876|116|P|   Before using aripiprazole, tell your doctor or pharmacist if||
0876|117|P|you are allergic to it; or if you have any other allergies. This||
0876|118|P|product may contain inactive ingredients, which can cause||
0876|119|P|allergic reactions or other problems. Talk to your pharmacist for||
0876|120|P|more details.||
0876|121|P|   Before using this medication, tell your doctor or pharmacist||
0876|122|P|your medical history, especially of: problems with receiving||
0876|123|P|injections into the buttocks, problems with blood flow in the||
0876|124|P|brain (such as cerebrovascular disease, stroke), blood clotting||
0876|125|P|problems (such as hemophilia, low platelets), diabetes (including||
0876|126|P|family history), heart problems (such as low blood pressure,||
0876|127|P|coronary artery disease), nervous system problems (such as||
0876|128|P|dementia, NMS, seizures), obesity, low white blood cell count||
0876|129|P|(including history of low white blood cell count caused by||
0876|130|P|medications), swallowing problems, breathing trouble during sleep||
0876|131|P|(sleep apnea).||
0876|132|P|   This drug may make you dizzy or drowsy or blur your vision.||
0876|133|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0876|134|P|drowsy. Do not drive, use machinery, or do anything that needs||
0876|135|P|alertness or clear vision until you can do it safely. Avoid||
0876|136|P|alcoholic beverages. Talk to your doctor if you are using||
0876|137|P|marijuana (cannabis).||
0876|138|P|   This medication may make you sweat less, making you more||
0876|139|P|likely to get heat stroke. Avoid doing things that may cause you||
0876|140|P|to overheat, such as hard work or exercise in hot weather, or||
0876|141|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0876|142|P|and dress lightly. If you overheat, quickly look for a place to||
0876|143|P|cool down and rest. Get medical help right away if you have a||
0876|144|P|fever that does not go away, mental/mood changes, headache, or||
0876|145|P|dizziness.||
0876|146|P|   Before having surgery, tell your doctor or dentist about all||
0876|147|P|the products you use (including prescription drugs,||
0876|148|P|nonprescription drugs, and herbal products).||
0876|149|P|   Older adults may be more sensitive to the side effects of this||
0876|150|P|drug, especially seizures, drowsiness, dizziness,||
0876|151|P|lightheadedness, confusion, tardive dyskinesia, swallowing||
0876|152|P|problems, and other serious (rarely fatal) side effects. (See||
0876|153|P|also Warning section.) Drowsiness, dizziness, lightheadedness,||
0876|154|P|and confusion can increase the risk of falling.||
0876|155|P|   During pregnancy, this medication should be used only when||
0876|156|P|clearly needed. Babies born to mothers who have used this drug||
0876|157|P|during the last 3 months of pregnancy may rarely develop symptoms||
0876|158|P|including muscle stiffness or shakiness, drowsiness,||
0876|159|P|feeding/breathing difficulties, or constant crying. If you notice||
0876|160|P|any of these symptoms in your newborn especially during their||
0876|161|P|first month, tell the doctor right away.||
0876|162|P|   Since untreated mental/mood problems (such as schizophrenia)||
0876|163|P|can be a serious condition, do not stop taking this medication||
0876|164|P|unless directed by your doctor. If you are planning pregnancy,||
0876|165|P|become pregnant, or think you may be pregnant, immediately||
0876|166|P|discuss with your doctor the benefits and risks of using this||
0876|167|P|medication during pregnancy.||
0876|168|P|   This medication passes into breast milk. Consult your doctor||
0876|169|P|before breastfeeding.||
0876|170|B|||
0876|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0876|172|I|medications work or increase your risk for serious side effects.||
0876|173|I|This document does not contain all possible drug interactions.||
0876|174|I|Keep a list of all the products you use (including||
0876|175|I|prescription/nonprescription drugs and herbal products) and share||
0876|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
0876|177|I|the dosage of any medicines without your doctor's approval.||
0876|178|I|   A product that may interact with this drug is: metoclopramide.||
0876|179|I|   Tell your doctor or pharmacist if you are taking other||
0876|180|I|products that cause drowsiness such as opioid pain or cough||
0876|181|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0876|182|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0876|183|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0876|184|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0876|185|I|diphenhydramine).||
0876|186|I|   Check the labels on all your medicines (such as allergy or||
0876|187|I|cough-and-cold products) because they may contain ingredients||
0876|188|I|that cause drowsiness. Ask your pharmacist about using those||
0876|189|I|products safely.||
0876|190|B|||
0876|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0876|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0876|193|O|poison control center right away. US residents can call||
0876|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0876|195|O|Symptoms of overdose may include: very fast heartbeat, loss of||
0876|196|O|consciousness.||
0876|197|B|||
0876|198|N|NOTES:  Lab and/or medical tests (such as blood sugar, weight,||
0876|199|N|cholesterol/triglyceride levels) may be done while you are using||
0876|200|N|this medication. Keep all medical and lab appointments. Consult||
0876|201|N|your doctor for more details.||
0876|202|B|||
0876|203|D|MISSED DOSE:  It is important to get each dose of this medication||
0876|204|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0876|205|D|right away for a new dosing schedule. Your doctor may direct you||
0876|206|D|to also take aripiprazole by mouth again for some time if more||
0876|207|D|than a certain number of weeks have passed since your last||
0876|208|D|injection. Follow your doctor's instructions carefully.||
0876|209|B|||
0876|210|R|STORAGE:  Not applicable. This medication is given in a hospital||
0876|211|R|or clinic and will not be stored at home.||
0876|212|B|||
0876|213|A|Information last revised September 2025.||
0876|214|A|Copyright(c) 2025 First Databank, Inc.||
0876|215|B|||
0878|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0878|002|Z|does NOT have all possible information about this product. This||
0878|003|Z|information does not assure that this product is safe, effective,||
0878|004|Z|or appropriate for you. This information is not individual||
0878|005|Z|medical advice and does not substitute for the advice of your||
0878|006|Z|health care professional. Always ask your health care||
0878|007|Z|professional for complete information about this product and your||
0878|008|Z|specific health needs.||
0878|009|B|||
0878|010|T|APOMORPHINE PEN - INJECTION||
0878|011|F|(A-poe-MOR-feen)||
0878|012|B|||
0878|013|C|COMMON BRAND NAME(S): Apokyn||
0878|014|B|||
0878|015|U|USES:  This medication is used to treat the symptoms of||
0878|016|U|Parkinson's disease. It can improve your ability to move during||
0878|017|U|frequent "off" periods. It can decrease shakiness (tremor),||
0878|018|U|stiffness, slowed movement, and unsteadiness. This medication is||
0878|019|U|thought to work by helping to restore the balance of a certain||
0878|020|U|natural substance (dopamine) in the brain.||
0878|021|U|   Apomorphine is used to treat "off" episodes when they occur.||
0878|022|U|It is not used to prevent "off" episodes. This drug should not be||
0878|023|U|used instead of your usual medications for Parkinson's disease.||
0878|024|U|Keep taking all your medications as directed by your doctor.||
0878|025|B|||
0878|026|H|HOW TO USE:  Read the Patient Information Leaflet and||
0878|027|H|Instructions for Use if available from your pharmacist before you||
0878|028|H|start using apomorphine and each time you get a refill. Ask your||
0878|029|H|health care professional how to prepare and use this medication.||
0878|030|H|If you have any questions, ask your doctor or pharmacist.||
0878|031|H|   Inject this medication under the skin as directed by your||
0878|032|H|doctor, usually as needed to treat decreased/frozen muscle||
0878|033|H|movement ("off" episode). The injection is given in the abdomen,||
0878|034|H|thighs, or upper arms. Do not inject this medication into a vein.||
0878|035|H|You may need to use this medication several times a day. Do not||
0878|036|H|use a second injection for the same "off" episode. Wait at least||
0878|037|H|2 hours between injections.||
0878|038|H|   The dosage is based on your medical condition and response to||
0878|039|H|treatment. To decrease the risk of side effects (such as nausea,||
0878|040|H|drowsiness, low blood pressure) when you first start using||
0878|041|H|apomorphine, your doctor will slowly increase your dosage until||
0878|042|H|the best dose for you is reached. Your doctor will usually have||
0878|043|H|you use the first dose in the office where your blood pressure||
0878|044|H|can be checked and you can be watched for side effects. Nausea is||
0878|045|H|very common with this medication. To decrease the risk of nausea,||
0878|046|H|your doctor may direct you to start taking another medication||
0878|047|H|(such as trimethobenzamide) 3 days before your first dose of||
0878|048|H|apomorphine and to keep taking as directed for up to 2 months.||
0878|049|H|   Before using, check this product for particles or||
0878|050|H|discoloration. If either is present, do not use the liquid.||
0878|051|H|Before injecting each dose, clean the skin you are going to||
0878|052|H|inject into (the injection site) with rubbing alcohol. Change the||
0878|053|H|injection site each time to lessen injury under the skin. Do not||
0878|054|H|inject into skin that is irritated, sore, or infected. To lessen||
0878|055|H|bruising, do not rub the injection site after a shot. Learn how||
0878|056|H|to store and discard medical supplies safely.||
0878|057|H|   Check the dose carefully before injecting. Apomorphine is||
0878|058|H|given by the milliliter, not by the milligram. There are 10||
0878|059|H|milligrams of drug in each milliliter of this liquid, so if the||
0878|060|H|wrong measuring unit is used, you may accidentally inject 10||
0878|061|H|times the amount of drug you need. Be sure you have the correct||
0878|062|H|dose to prevent accidental overdose. If you are not sure how to||
0878|063|H|measure your dose correctly, consult your pharmacist before||
0878|064|H|injecting.||
0878|065|H|   If you are using the prefilled cartridge/pen, keep track of||
0878|066|H|the doses used to make sure there is enough medication left in||
0878|067|H|the device to give you a full dose.||
0878|068|H|   Use this medication as prescribed. If you stop using this||
0878|069|H|medication for longer than 1 week, you may need to increase your||
0878|070|H|dose slowly back to your previous dosage. Talk with your doctor||
0878|071|H|about how to restart the medication. Do not stop using this||
0878|072|H|medication without your doctor's approval.||
0878|073|H|   If you are using this medication often and suddenly stop using||
0878|074|H|it, you may have withdrawal symptoms (such as anxiety,||
0878|075|H|depression, confusion, fever, muscle stiffness). To help prevent||
0878|076|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0878|077|H|more likely if you have used apomorphine for a long time or in||
0878|078|H|high doses. Tell your doctor or pharmacist right away if you have||
0878|079|H|withdrawal.||
0878|080|H|   Rarely, abnormal drug-seeking behavior (drug abuse) is||
0878|081|H|possible with this medication. Do not increase your dose or use||
0878|082|H|it more often than prescribed. Properly stop the medication when||
0878|083|H|so directed.||
0878|084|H|   Tell your doctor if your condition does not get better or if||
0878|085|H|it gets worse.||
0878|086|B|||
0878|087|S|SIDE EFFECTS:  Redness/swelling/pain/itching at the injection||
0878|088|S|site, nausea, vomiting, headache, sweating, dizziness,||
0878|089|S|drowsiness, yawning, or runny nose may occur. If any of these||
0878|090|S|effects last or get worse, tell your doctor or pharmacist||
0878|091|S|promptly.||
0878|092|S|   Remember that this medication has been prescribed because your||
0878|093|S|doctor has judged that the benefit to you is greater than the||
0878|094|S|risk of side effects. Many people using this medication do not||
0878|095|S|have serious side effects.||
0878|096|S|   Tell your doctor right away if you have any serious side||
0878|097|S|effects, including: uncontrolled movements, mental/mood changes||
0878|098|S|(such as confusion, agitation, hallucinations), muscle||
0878|099|S|cramps/spasm, swelling of the hands/legs/ankles/feet, unusual||
0878|100|S|strong urges (such as increased gambling, increased sexual||
0878|101|S|urges), unusual tiredness, pale skin.||
0878|102|S|   Get medical help right away if you have any very serious side||
0878|103|S|effects, including: chest pain, shortness of breath,||
0878|104|S|fast/irregular heartbeat, severe dizziness, fainting, trouble||
0878|105|S|speaking, vision changes, weakness on one side of the body.||
0878|106|S|   Some people using apomorphine have fallen asleep suddenly||
0878|107|S|during their usual daily activities (such as talking on the||
0878|108|S|phone, driving). In some cases, sleep occurred without any||
0878|109|S|feelings of drowsiness beforehand. This sleep effect may occur||
0878|110|S|anytime during treatment with apomorphine even if you have used||
0878|111|S|this medication for a long time. If you experience increased||
0878|112|S|sleepiness or fall asleep during the day, do not drive or take||
0878|113|S|part in other possibly dangerous activities until you have||
0878|114|S|discussed this effect with your doctor. Your risk of this sleep||
0878|115|S|effect is increased by using alcohol or other medications that||
0878|116|S|can make you drowsy. See also Precautions section.||
0878|117|S|   You may also develop a sudden drop in blood pressure that can||
0878|118|S|cause dizziness, nausea, and fainting. This effect may also||
0878|119|S|increase your risk of a fall. This drop in blood pressure is more||
0878|120|S|likely when you are first starting the medication, when your dose||
0878|121|S|is increased, or when you get up suddenly. To lower your risk,||
0878|122|S|get up slowly from a sitting or lying position. Avoid alcohol.||
0878|123|S|   Rarely, males may have a painful or prolonged erection lasting||
0878|124|S|4 or more hours. If this occurs, stop using this drug and get||
0878|125|S|medical help right away, or permanent problems could occur.||
0878|126|S|   A very serious allergic reaction to this drug is rare.||
0878|127|S|However, get medical help right away if you notice any symptoms||
0878|128|S|of a serious allergic reaction, including: rash, itching/swelling||
0878|129|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0878|130|S|breathing.||
0878|131|S|   This is not a complete list of possible side effects. If you||
0878|132|S|notice other effects not listed above, contact your doctor or||
0878|133|S|pharmacist.||
0878|134|S|   In the US -||
0878|135|S|   Call your doctor for medical advice about side effects. You||
0878|136|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0878|137|S|www.fda.gov/medwatch.||
0878|138|S|   In Canada - Call your doctor for medical advice about side||
0878|139|S|effects. You may report side effects to Health Canada at||
0878|140|S|1-866-234-2345.||
0878|141|B|||
0878|142|P|PRECAUTIONS:  Before using apomorphine, tell your doctor or||
0878|143|P|pharmacist if you are allergic to it; or if you have any other||
0878|144|P|allergies. This product may contain inactive ingredients (such as||
0878|145|P|sulfites), which can cause allergic reactions or other problems.||
0878|146|P|Talk to your pharmacist for more details.||
0878|147|P|   Before using this medication, tell your doctor or pharmacist||
0878|148|P|your medical history, especially of: asthma, heart problems (such||
0878|149|P|as chest pain, heart attack), mental/mood disorders (such as||
0878|150|P|hallucinations, psychosis, schizophrenia), kidney problems, liver||
0878|151|P|problems, low blood pressure, sleep disorder (such as sleep||
0878|152|P|apnea, narcolepsy), stroke.||
0878|153|P|   Apomorphine may cause a condition that affects the heart||
0878|154|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0878|155|P|serious (rarely fatal) fast/irregular heartbeat and other||
0878|156|P|symptoms (such as severe dizziness, fainting) that need medical||
0878|157|P|attention right away.||
0878|158|P|   The risk of QT prolongation may be increased if you have||
0878|159|P|certain medical conditions or are taking other drugs that may||
0878|160|P|cause QT prolongation. Before using apomorphine, tell your doctor||
0878|161|P|or pharmacist of all the drugs you take and if you have any of||
0878|162|P|the following conditions: certain heart problems (heart failure,||
0878|163|P|slow heartbeat, QT prolongation in the EKG), family history of||
0878|164|P|certain heart problems (QT prolongation in the EKG, sudden||
0878|165|P|cardiac death).||
0878|166|P|   Low levels of potassium or magnesium in the blood may also||
0878|167|P|increase your risk of QT prolongation. This risk may increase if||
0878|168|P|you use certain drugs (such as diuretics/"water pills") or if you||
0878|169|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0878|170|P|Talk to your doctor about using apomorphine safely.||
0878|171|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0878|172|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0878|173|P|machinery, or do anything that needs alertness until you can do||
0878|174|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0878|175|P|are using marijuana (cannabis). See also Side Effects section.||
0878|176|P|   Older adults may be more sensitive to the side effects of this||
0878|177|P|drug, especially falls, mental/mood changes (such as confusion,||
0878|178|P|hallucinations), and QT prolongation (see above).||
0878|179|P|   During pregnancy, this medication should be used only when||
0878|180|P|clearly needed. Discuss the risks and benefits with your doctor.||
0878|181|P|   It is unknown if this drug passes into breast milk. Consult||
0878|182|P|your doctor before breastfeeding.||
0878|183|B|||
0878|184|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0878|185|I|medications work or increase your risk for serious side effects.||
0878|186|I|This document does not contain all possible drug interactions.||
0878|187|I|Keep a list of all the products you use (including||
0878|188|I|prescription/nonprescription drugs and herbal products) and share||
0878|189|I|it with your doctor and pharmacist. Do not start, stop, or change||
0878|190|I|the dosage of any medicines without your doctor's approval.||
0878|191|I|   Some products that may interact with this drug are: alosetron,||
0878|192|I|certain drugs for nausea (including metoclopramide,||
0878|193|I|phenothiazines such as prochlorperazine, serotonin blockers such||
0878|194|I|as ondansetron, granisetron).||
0878|195|I|   Tell your doctor or pharmacist if you are taking other||
0878|196|I|products that cause drowsiness such as opioid pain or cough||
0878|197|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0878|198|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0878|199|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0878|200|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0878|201|I|diphenhydramine).||
0878|202|I|   Check the labels on all your medicines (such as allergy or||
0878|203|I|cough-and-cold products) because they may contain ingredients||
0878|204|I|that cause drowsiness. Ask your pharmacist about using those||
0878|205|I|products safely.||
0878|206|B|||
0878|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0878|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0878|209|O|poison control center right away. US residents can call||
0878|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0878|211|O|Symptoms of overdose may include: very severe nausea/vomiting,||
0878|212|O|loss of consciousness.||
0878|213|B|||
0878|214|N|NOTES:  Do not share this medication with others.||
0878|215|B|||
0878|216|D|MISSED DOSE:  Not applicable.||
0878|217|B|||
0878|218|R|STORAGE:  Store at room temperature away from moisture. Do not||
0878|219|R|store in the bathroom. Keep all medications away from children||
0878|220|R|and pets.||
0878|221|R|   Syringes can be filled the night before use and stored in the||
0878|222|R|refrigerator until the next day. Discard this type of pre-filled||
0878|223|R|syringe if not used in 24 hours.||
0878|224|R|   Do not flush medications down the toilet or pour them into a||
0878|225|R|drain unless instructed to do so. Properly discard this product||
0878|226|R|when it is expired or no longer needed. Consult your pharmacist||
0878|227|R|or local waste disposal company.||
0878|228|B|||
0878|229|A|Information last revised March 2025.||
0878|230|A|Copyright(c) 2025 First Databank, Inc.||
0878|231|B|||
0882|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0882|002|Z|does NOT have all possible information about this product. This||
0882|003|Z|information does not assure that this product is safe, effective,||
0882|004|Z|or appropriate for you. This information is not individual||
0882|005|Z|medical advice and does not substitute for the advice of your||
0882|006|Z|health care professional. Always ask your health care||
0882|007|Z|professional for complete information about this product and your||
0882|008|Z|specific health needs.||
0882|009|B|||
0882|010|T|PALIPERIDONE EXTENDED-RELEASE - ORAL||
0882|011|F|(PAL-ee-PER-i-done)||
0882|012|B|||
0882|013|C|COMMON BRAND NAME(S): Invega||
0882|014|B|||
0882|015|W|WARNING:  There may be a slightly increased risk of serious,||
0882|016|W|possibly fatal side effects (such as stroke, heart failure,||
0882|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
0882|018|W|by older adults with dementia. This medication is not approved||
0882|019|W|for the treatment of dementia-related behavior problems. Discuss||
0882|020|W|the risks and benefits of this medication, as well as other||
0882|021|W|effective and possibly safer treatments for dementia-related||
0882|022|W|behavior problems, with the doctor.||
0882|023|W|   If you are using paliperidone in combination with other||
0882|024|W|medication to treat depression, also carefully read the drug||
0882|025|W|information for the other medication.||
0882|026|B|||
0882|027|U|USES:  This medication is used to treat certain mental/mood||
0882|028|U|disorders (such as schizophrenia, schizoaffective disorder).||
0882|029|U|Paliperidone belongs to a class of drugs known as atypical||
0882|030|U|antipsychotics. It works by helping to restore the balance of||
0882|031|U|certain natural substances in the brain.||
0882|032|B|||
0882|033|V|OTHER USES:  This section contains uses of this drug that are not||
0882|034|V|listed in the approved professional labeling for the drug but||
0882|035|V|that may be prescribed by your health care professional. Use this||
0882|036|V|drug for a condition that is listed in this section only if it||
0882|037|V|has been so prescribed by your health care professional.||
0882|038|V|   This drug may also be used in combination with other||
0882|039|V|medication for depression.||
0882|040|B|||
0882|041|H|HOW TO USE:  Take this medication by mouth with or without food||
0882|042|H|as directed by your doctor, usually once daily. Swallow the||
0882|043|H|tablets whole with liquid. Do not crush or chew the tablets.||
0882|044|H|Doing so can release all of the drug at once, increasing the risk||
0882|045|H|of side effects.||
0882|046|H|   The dosage is based on your age, medical condition, and||
0882|047|H|response to treatment.||
0882|048|H|   Take this medication regularly to get the most benefit from||
0882|049|H|it. To help you remember, take it at the same time each day. Keep||
0882|050|H|taking this medication even if you feel well. Do not stop taking||
0882|051|H|this medication without consulting your doctor.||
0882|052|H|   Tell your doctor if your condition lasts or gets worse.||
0882|053|B|||
0882|054|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, drooling,||
0882|055|S|stomach/abdominal pain, weight gain, or tiredness may occur. If||
0882|056|S|any of these effects last or get worse, tell your doctor||
0882|057|S|promptly.||
0882|058|S|   Dizziness and lightheadedness can increase the risk of||
0882|059|S|falling. Get up slowly when rising from a sitting or lying||
0882|060|S|position.||
0882|061|S|   An empty tablet shell may appear in your stool. This effect is||
0882|062|S|harmless because your body has already absorbed the medication.||
0882|063|S|   Remember that this medication has been prescribed because your||
0882|064|S|doctor has judged that the benefit to you is greater than the||
0882|065|S|risk of side effects. Many people using this medication do not||
0882|066|S|have serious side effects.||
0882|067|S|   Tell your doctor right away if you have any serious side||
0882|068|S|effects, including: difficulty swallowing, muscle spasms, shaking||
0882|069|S|(tremor), mental/mood changes (such as restlessness), interrupted||
0882|070|S|breathing during sleep.||
0882|071|S|   This drug may rarely make your blood sugar rise, which can||
0882|072|S|cause or worsen diabetes. Tell your doctor right away if you have||
0882|073|S|symptoms of high blood sugar such as increased thirst/urination.||
0882|074|S|If you already have diabetes, check your blood sugar regularly as||
0882|075|S|directed and share the results with your doctor. Your doctor may||
0882|076|S|need to adjust your diabetes medication, exercise program, or||
0882|077|S|diet.||
0882|078|S|   This drug may also cause significant weight gain and a rise in||
0882|079|S|your blood cholesterol (or triglyceride) levels. These effects,||
0882|080|S|along with diabetes, may increase your risk for developing heart||
0882|081|S|disease. Discuss the risks and benefits of treatment with your||
0882|082|S|doctor. (See also Notes section.)||
0882|083|S|   Paliperidone may rarely cause a condition known as tardive||
0882|084|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0882|085|S|your doctor right away if you develop any unusual/uncontrolled||
0882|086|S|movements (especially of the face, lips, mouth, tongue, arms, or||
0882|087|S|legs).||
0882|088|S|   This medication may increase a certain natural substance||
0882|089|S|(prolactin) made by your body. For females, this increase in||
0882|090|S|prolactin may result in unwanted breast milk, missed/stopped||
0882|091|S|periods, or difficulty becoming pregnant. For males, it may||
0882|092|S|result in decreased sexual ability, inability to produce sperm,||
0882|093|S|or enlarged breasts. If you develop any of these symptoms, tell||
0882|094|S|your doctor right away.||
0882|095|S|   Get medical help right away if you have any very serious side||
0882|096|S|effects, including: severe dizziness, fainting, seizures.||
0882|097|S|   This medication may rarely cause a very serious condition||
0882|098|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0882|099|S|right away if you have any of the following symptoms: fever,||
0882|100|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
0882|101|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
0882|102|S|signs of kidney problems (such as change in the amount of urine).||
0882|103|S|   Rarely, males may have a painful or prolonged erection lasting||
0882|104|S|4 or more hours. If this occurs, stop using this drug and get||
0882|105|S|medical help right away, or permanent problems could occur.||
0882|106|S|   A very serious allergic reaction to this drug is rare.||
0882|107|S|However, get medical help right away if you notice any symptoms||
0882|108|S|of a serious allergic reaction, including: fever, swollen lymph||
0882|109|S|nodes, rash, itching/swelling (especially of the||
0882|110|S|face/tongue/throat), severe dizziness, trouble breathing.||
0882|111|S|   This is not a complete list of possible side effects. If you||
0882|112|S|notice other effects not listed above, contact your doctor or||
0882|113|S|pharmacist.||
0882|114|S|   In the US -||
0882|115|S|   Call your doctor for medical advice about side effects. You||
0882|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0882|117|S|www.fda.gov/medwatch.||
0882|118|S|   In Canada - Call your doctor for medical advice about side||
0882|119|S|effects. You may report side effects to Health Canada at||
0882|120|S|1-866-234-2345.||
0882|121|B|||
0882|122|P|PRECAUTIONS:  Before taking paliperidone, tell your doctor or||
0882|123|P|pharmacist if you are allergic to it; or to risperidone; or if||
0882|124|P|you have any other allergies. This product may contain inactive||
0882|125|P|ingredients, which can cause allergic reactions or other||
0882|126|P|problems. Talk to your pharmacist for more details.||
0882|127|P|   Before using this medication, tell your doctor or pharmacist||
0882|128|P|your medical history, especially of: liver disease, kidney||
0882|129|P|disease, seizures, low white blood cell count, Parkinson's||
0882|130|P|disease, dementia, esophagus/stomach/intestinal movement or||
0882|131|P|blockage disorders (such as difficulty swallowing, peritonitis,||
0882|132|P|cystic fibrosis, Meckel's diverticulum), certain eye problems||
0882|133|P|(cataracts, glaucoma), personal or family history of diabetes,||
0882|134|P|high cholesterol/triglyceride levels, heart disease, breathing||
0882|135|P|trouble during sleep (sleep apnea).||
0882|136|P|   Paliperidone may cause a condition that affects the heart||
0882|137|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0882|138|P|serious (rarely fatal) fast/irregular heartbeat and other||
0882|139|P|symptoms (such as severe dizziness, fainting) that need medical||
0882|140|P|attention right away.||
0882|141|P|   The risk of QT prolongation may be increased if you have||
0882|142|P|certain medical conditions or are taking other drugs that may||
0882|143|P|cause QT prolongation. Before using paliperidone, tell your||
0882|144|P|doctor or pharmacist of all the drugs you take and if you have||
0882|145|P|any of the following conditions: certain heart problems (heart||
0882|146|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0882|147|P|history of certain heart problems (QT prolongation in the EKG,||
0882|148|P|sudden cardiac death).||
0882|149|P|   Low levels of potassium or magnesium in the blood may also||
0882|150|P|increase your risk of QT prolongation. This risk may increase if||
0882|151|P|you use certain drugs (such as diuretics/"water pills") or if you||
0882|152|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0882|153|P|Talk to your doctor about using paliperidone safely.||
0882|154|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0882|155|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0882|156|P|machinery, or do anything that needs alertness until you can do||
0882|157|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0882|158|P|are using marijuana (cannabis).||
0882|159|P|   Before having surgery (including cataract/glaucoma eye||
0882|160|P|surgery), tell your doctor or dentist if you are taking or have||
0882|161|P|ever taken this medication, and about all the other products you||
0882|162|P|use (including prescription drugs, nonprescription drugs, and||
0882|163|P|herbal products).||
0882|164|P|   This medication may make you sweat less, making you more||
0882|165|P|likely to get heat stroke. Avoid doing things that may cause you||
0882|166|P|to overheat, such as hard work or exercise in hot weather, or||
0882|167|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0882|168|P|and dress lightly. If you overheat, quickly look for a place to||
0882|169|P|cool down and rest. Get medical help right away if you have a||
0882|170|P|fever that does not go away, mental/mood changes, headache, or||
0882|171|P|dizziness.||
0882|172|P|   Older adults may be more sensitive to the side effects of this||
0882|173|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
0882|174|P|prolongation (see above). Drowsiness, dizziness, and||
0882|175|P|lightheadedness can increase the risk of falling.||
0882|176|P|   During pregnancy, this medication should be used only when||
0882|177|P|clearly needed. Babies born to mothers who have used this drug||
0882|178|P|during the last 3 months of pregnancy may rarely develop symptoms||
0882|179|P|including muscle stiffness or shakiness, drowsiness,||
0882|180|P|feeding/breathing difficulties, or constant crying. If you notice||
0882|181|P|any of these symptoms in your newborn especially during their||
0882|182|P|first month, tell the doctor right away.||
0882|183|P|   Since untreated mental/mood problems (such as schizophrenia,||
0882|184|P|schizoaffective disorders, depression) can be a serious||
0882|185|P|condition, do not stop taking this medication unless directed by||
0882|186|P|your doctor. If you are planning pregnancy, become pregnant, or||
0882|187|P|think you may be pregnant, immediately discuss with your doctor||
0882|188|P|the benefits and risks of using this medication during pregnancy.||
0882|189|P|   This medication passes into breast milk and may have||
0882|190|P|undesirable effects on a nursing infant. Tell the doctor right||
0882|191|P|away if your baby develops symptoms such as muscle stiffness or||
0882|192|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
0882|193|P|your doctor before breastfeeding.||
0882|194|B|||
0882|195|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0882|196|I|medications work or increase your risk for serious side effects.||
0882|197|I|This document does not contain all possible drug interactions.||
0882|198|I|Keep a list of all the products you use (including||
0882|199|I|prescription/nonprescription drugs and herbal products) and share||
0882|200|I|it with your doctor and pharmacist. Do not start, stop, or change||
0882|201|I|the dosage of any medicines without your doctor's approval.||
0882|202|I|   A product that may interact with this drug is: metoclopramide.||
0882|203|I|   Many drugs besides paliperidone may affect the heart rhythm||
0882|204|I|(QT prolongation), including amiodarone, chlorpromazine,||
0882|205|I|moxifloxacin, quinidine, sotalol, procainamide, thioridazine,||
0882|206|I|among others.||
0882|207|I|   Tell your doctor or pharmacist if you are taking other||
0882|208|I|products that cause drowsiness such as opioid pain or cough||
0882|209|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0882|210|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0882|211|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0882|212|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0882|213|I|diphenhydramine).||
0882|214|I|   Check the labels on all your medicines (such as allergy or||
0882|215|I|cough-and-cold products) because they may contain ingredients||
0882|216|I|that cause drowsiness. Ask your pharmacist about using those||
0882|217|I|products safely.||
0882|218|B|||
0882|219|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0882|220|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0882|221|O|poison control center right away. US residents can call||
0882|222|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0882|223|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
0882|224|O|fast/irregular heartbeat, unusual/uncontrolled movements.||
0882|225|B|||
0882|226|N|NOTES:  Do not share this medication with others.||
0882|227|N|   Lab and/or medical tests (such as blood sugar, weight, blood||
0882|228|N|pressure, blood cholesterol/triglyceride levels) should be done||
0882|229|N|while you are taking this medication. Keep all medical and lab||
0882|230|N|appointments. Consult your doctor for more details.||
0882|231|B|||
0882|232|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0882|233|D|remember. If it is near the time of the next dose, skip the||
0882|234|D|missed dose. Take your next dose at the regular time. Do not||
0882|235|D|double the dose to catch up.||
0882|236|B|||
0882|237|R|STORAGE:  Store at room temperature away from light and moisture.||
0882|238|R|Do not store in the bathroom. Keep all medications away from||
0882|239|R|children and pets.||
0882|240|R|   Do not flush medications down the toilet or pour them into a||
0882|241|R|drain unless instructed to do so. Properly discard this product||
0882|242|R|when it is expired or no longer needed. Consult your pharmacist||
0882|243|R|or local waste disposal company.||
0882|244|B|||
0882|245|A|Information last revised May 2024.||
0882|246|A|Copyright(c) 2025 First Databank, Inc.||
0882|247|B|||
0884|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0884|002|Z|does NOT have all possible information about this product. This||
0884|003|Z|information does not assure that this product is safe, effective,||
0884|004|Z|or appropriate for you. This information is not individual||
0884|005|Z|medical advice and does not substitute for the advice of your||
0884|006|Z|health care professional. Always ask your health care||
0884|007|Z|professional for complete information about this product and your||
0884|008|Z|specific health needs.||
0884|009|B|||
0884|010|T|DESLORATADINE/PSEUDOEPHEDRINE EXTENDED-RELEASE - ORAL||
0884|011|F|(des-lor-AT-uh-deen/sue-doh-eff-ED-rin)||
0884|012|B|||
0884|013|C|COMMON BRAND NAME(S): Clarinex-D 12 Hour, Clarinex-D 24 Hour||
0884|014|B|||
0884|015|U|USES:  This medication is used to relieve allergy symptoms such||
0884|016|U|as watery eyes, runny/stuffy nose, itching eyes/nose, and||
0884|017|U|sneezing. It contains 2 medications: desloratadine and||
0884|018|U|pseudoephedrine. Desloratadine is an antihistamine and works by||
0884|019|U|blocking a certain natural substance (histamine) that your body||
0884|020|U|makes during an allergic reaction. Pseudoephedrine is a||
0884|021|U|decongestant and works by narrowing the blood vessels in the nose||
0884|022|U|to decrease swelling and congestion.||
0884|023|U|   This medication is not recommended for use in children younger||
0884|024|U|than 12 years of age due to the large amount of pseudoephedrine||
0884|025|U|in it.||
0884|026|B|||
0884|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0884|028|H|from your pharmacist before you start taking this product and||
0884|029|H|each time you get a refill. If you have any questions, ask your||
0884|030|H|doctor or pharmacist.||
0884|031|H|   Take this medication by mouth with or without food as directed||
0884|032|H|by your doctor. Swallow the tablets whole. Do not crush or chew||
0884|033|H|the tablets. Doing so can release all of the drug at once,||
0884|034|H|increasing the risk of side effects.||
0884|035|H|   Do not increase your dose or take this medication more often||
0884|036|H|than directed.||
0884|037|H|   Tell your doctor if your condition does not get better or if||
0884|038|H|it gets worse.||
0884|039|B|||
0884|040|S|SIDE EFFECTS:  Dizziness, tiredness, dry mouth, sore throat,||
0884|041|S|trouble sleeping, nausea, or headache may occur. If any of these||
0884|042|S|effects last or get worse, tell your doctor or pharmacist||
0884|043|S|promptly.||
0884|044|S|   Remember that this medication has been prescribed because your||
0884|045|S|doctor has judged that the benefit to you is greater than the||
0884|046|S|risk of side effects. Many people using this medication do not||
0884|047|S|have serious side effects.||
0884|048|S|   This medication may raise your blood pressure. Check your||
0884|049|S|blood pressure regularly and tell your doctor if the results are||
0884|050|S|high.||
0884|051|S|   Tell your doctor right away if you have any serious side||
0884|052|S|effects, including: fast/irregular/pounding heartbeat, shaking||
0884|053|S|(tremor), mental/mood changes (such as anxiety, confusion,||
0884|054|S|nervousness, restlessness), problems urinating.||
0884|055|S|   Get medical help right away if you have any very serious side||
0884|056|S|effects, including: seizures.||
0884|057|S|   A very serious allergic reaction to this drug is rare.||
0884|058|S|However, get medical help right away if you notice any symptoms||
0884|059|S|of a serious allergic reaction, including: rash, itching/swelling||
0884|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0884|061|S|breathing.||
0884|062|S|   This is not a complete list of possible side effects. If you||
0884|063|S|notice other effects not listed above, contact your doctor or||
0884|064|S|pharmacist.||
0884|065|S|   In the US -||
0884|066|S|   Call your doctor for medical advice about side effects. You||
0884|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0884|068|S|www.fda.gov/medwatch.||
0884|069|S|   In Canada - Call your doctor for medical advice about side||
0884|070|S|effects. You may report side effects to Health Canada at||
0884|071|S|1-866-234-2345.||
0884|072|B|||
0884|073|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0884|074|P|pharmacist if you are allergic to desloratadine or||
0884|075|P|pseudoephedrine; or to loratadine; or if you have any other||
0884|076|P|allergies. Also, tell your doctor if you have had serious side||
0884|077|P|effects from similar medications (such as other decongestants,||
0884|078|P|including phenylephrine). This product may contain inactive||
0884|079|P|ingredients, which can cause allergic reactions or other||
0884|080|P|problems. Talk to your pharmacist for more details.||
0884|081|P|   Before using this medication, tell your doctor or pharmacist||
0884|082|P|your medical history, especially of: glaucoma, difficulty||
0884|083|P|urinating (such as due to an enlarged prostate), high blood||
0884|084|P|pressure (hypertension), heart/blood vessel disease (such as||
0884|085|P|coronary artery disease), overactive thyroid (hyperthyroidism),||
0884|086|P|diabetes, kidney disease, liver disease.||
0884|087|P|   This drug does not usually make you drowsy when used at||
0884|088|P|recommended doses. However, this drug may make you dizzy. Alcohol||
0884|089|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
0884|090|P|use machinery, or do anything that needs alertness until you can||
0884|091|P|do it safely. Limit alcoholic beverages. Talk to your doctor if||
0884|092|P|you are using marijuana (cannabis).||
0884|093|P|   Before having surgery, tell your doctor or dentist about all||
0884|094|P|the products you use (including prescription drugs,||
0884|095|P|nonprescription drugs, and herbal products).||
0884|096|P|   Older adults may be more sensitive to the side effects of this||
0884|097|P|drug, especially fast/irregular heartbeat, dizziness, problems||
0884|098|P|urinating, trouble sleeping, or confusion.||
0884|099|P|   During pregnancy, this medication should be used only when||
0884|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0884|101|P|   This drug passes into breast milk. Consult your doctor before||
0884|102|P|breastfeeding.||
0884|103|B|||
0884|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0884|105|I|medications work or increase your risk for serious side effects.||
0884|106|I|This document does not contain all possible drug interactions.||
0884|107|I|Keep a list of all the products you use (including||
0884|108|I|prescription/nonprescription drugs and herbal products) and share||
0884|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
0884|110|I|the dosage of any medicines without your doctor's approval.||
0884|111|I|   Taking MAO inhibitors with this medication may cause a serious||
0884|112|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0884|113|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0884|114|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0884|115|I|selegiline, tranylcypromine) during treatment with this||
0884|116|I|medication. Most MAO inhibitors should also not be taken for two||
0884|117|I|weeks before treatment with this medication. Ask your doctor when||
0884|118|I|to start or stop taking this medication.||
0884|119|I|   Check the labels on all your medicines (such as cough-and-cold||
0884|120|I|products) because they may contain similar ingredients||
0884|121|I|(decongestants such as phenylephrine). Ask your pharmacist about||
0884|122|I|using those products safely.||
0884|123|I|   Desloratadine is very similar to loratadine. Do not use||
0884|124|I|medications containing loratadine while using desloratadine.||
0884|125|I|   This medication may interfere with certain lab tests (such as||
0884|126|I|allergy skin testing), possibly causing false test results. Make||
0884|127|I|sure lab personnel and all your doctors know you use this drug.||
0884|128|B|||
0884|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0884|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0884|131|O|poison control center right away. US residents can call||
0884|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0884|133|O|Symptoms of overdose may include: fast/irregular heartbeat,||
0884|134|O|mental/mood changes (such as anxiety, restlessness), drowsiness,||
0884|135|O|seizures.||
0884|136|B|||
0884|137|N|NOTES:  Do not share this medication with others.||
0884|138|B|||
0884|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0884|140|D|remember. If it is near the time of the next dose, skip the||
0884|141|D|missed dose. Take your next dose at the regular time. Do not||
0884|142|D|double the dose to catch up.||
0884|143|B|||
0884|144|R|STORAGE:  Store at room temperature away from light and moisture.||
0884|145|R|Do not store in the bathroom. Keep all medications away from||
0884|146|R|children and pets.||
0884|147|R|   Do not flush medications down the toilet or pour them into a||
0884|148|R|drain unless instructed to do so. Properly discard this product||
0884|149|R|when it is expired or no longer needed. Consult your pharmacist||
0884|150|R|or local waste disposal company.||
0884|151|B|||
0884|152|A|Information last revised July 2025.||
0884|153|A|Copyright(c) 2025 First Databank, Inc.||
0884|154|B|||
0885|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0885|002|Z|does NOT have all possible information about this product. This||
0885|003|Z|information does not assure that this product is safe, effective,||
0885|004|Z|or appropriate for you. This information is not individual||
0885|005|Z|medical advice and does not substitute for the advice of your||
0885|006|Z|health care professional. Always ask your health care||
0885|007|Z|professional for complete information about this product and your||
0885|008|Z|specific health needs.||
0885|009|B|||
0885|010|T|DIPHENHYDRAMINE - TOPICAL||
0885|011|F|(dye-fen-HI-druh-meen)||
0885|012|B|||
0885|013|C|COMMON BRAND NAME(S): Benadryl||
0885|014|B|||
0885|015|U|USES:  This medication is used to temporarily relieve itching and||
0885|016|U|pain caused by minor burns/cuts/scrapes, sunburn, insect bites,||
0885|017|U|minor skin irritations, or rashes from poison ivy, poison oak, or||
0885|018|U|poison sumac.||
0885|019|U|   Diphenhydramine belongs to a class of drugs known as||
0885|020|U|antihistamines. It works by blocking the effects of a certain||
0885|021|U|natural substance (histamine) that causes itching. This product||
0885|022|U|may also contain other ingredients (skin protectants such as||
0885|023|U|allantoin, zinc acetate) that may help relieve symptoms such as||
0885|024|U|dry skin, weeping, or oozing. Read the product package for more||
0885|025|U|information.||
0885|026|U|   Depending on the brand and the form of diphenhydramine skin||
0885|027|U|product you are using, the package information may state that its||
0885|028|U|use is not recommended in children younger than 2, 6, or 12 years||
0885|029|U|unless directed by the doctor.||
0885|030|U|   If you are self-treating with this medication, it is important||
0885|031|U|to read the package instructions carefully before you start using||
0885|032|U|this product to be sure it is right for you. (See also||
0885|033|U|Precautions section.)||
0885|034|B|||
0885|035|H|HOW TO USE:  Use this medication only on the skin as directed by||
0885|036|H|your doctor. If you are self-treating, follow all directions on||
0885|037|H|the product package. If you have any questions, ask your doctor||
0885|038|H|or pharmacist. Some products may need to be shaken well before||
0885|039|H|use.||
0885|040|H|   Before applying, clean the affected area with soap and water.||
0885|041|H|Gently pat dry. Apply to the affected area as directed, usually||
0885|042|H|no more than 3 to 4 times a day. Wash hands immediately after||
0885|043|H|use, unless the area being treated includes the hands.||
0885|044|H|   Do not use on large areas of the body or use more often than||
0885|045|H|directed. Your condition will not improve any faster, and your||
0885|046|H|risk of side effects will increase.||
0885|047|H|   Avoid getting the product in your eyes, nose, ears, or mouth.||
0885|048|H|If the medication gets in these areas, wipe it off and rinse the||
0885|049|H|area right away with water.||
0885|050|H|   Stop using this product and tell your doctor if your condition||
0885|051|H|gets worse, if symptoms do not get better within 7 days or last||
0885|052|H|after 7 days of treatment, or if symptoms clear up and return in||
0885|053|H|a few days. If you think you may have a serious medical problem,||
0885|054|H|get medical help right away.||
0885|055|B|||
0885|056|S|SIDE EFFECTS:  Mild stinging may occur. If this effect lasts or||
0885|057|S|gets worse, stop using this product and tell your doctor or||
0885|058|S|pharmacist promptly.||
0885|059|S|   If your doctor has directed you to use this medication,||
0885|060|S|remember that your doctor has judged that the benefit to you is||
0885|061|S|greater than the risk of side effects. Many people using this||
0885|062|S|medication do not have serious side effects.||
0885|063|S|   Though very unlikely, it is possible this medication could be||
0885|064|S|absorbed into your blood. Children using this drug for an||
0885|065|S|extended time over large areas of the skin (especially areas with||
0885|066|S|broken skin) may be at higher risk, especially if they also are||
0885|067|S|using other diphenhydramine products taken by mouth or applied to||
0885|068|S|the skin. Stop using this product and tell the doctor right away||
0885|069|S|if any of the following serious side effects occur: enlarged||
0885|070|S|pupils in the eyes, face flushing, mental/mood changes (such as||
0885|071|S|hallucinations, unusual excitement, confusion), difficulty||
0885|072|S|walking, difficulty urinating.||
0885|073|S|   A very serious allergic reaction to this drug is rare.||
0885|074|S|However, get medical help right away if you notice any symptoms||
0885|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0885|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0885|077|S|breathing.||
0885|078|S|   This is not a complete list of possible side effects. If you||
0885|079|S|notice other effects not listed above, contact your doctor or||
0885|080|S|pharmacist.||
0885|081|S|   In the US -||
0885|082|S|   Call your doctor for medical advice about side effects. You||
0885|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0885|084|S|www.fda.gov/medwatch.||
0885|085|S|   In Canada - Call your doctor for medical advice about side||
0885|086|S|effects. You may report side effects to Health Canada at||
0885|087|S|1-866-234-2345.||
0885|088|B|||
0885|089|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0885|090|P|pharmacist if you are allergic to diphenhydramine; or to any of||
0885|091|P|the other ingredients listed on the product package; or to||
0885|092|P|dimenhydrinate; or if you have any other allergies. This product||
0885|093|P|may contain inactive ingredients, which can cause allergic||
0885|094|P|reactions or other problems. Talk to your pharmacist for more||
0885|095|P|details.||
0885|096|P|   Before using this medication, tell your doctor or pharmacist||
0885|097|P|your medical history, especially if you are self-treating:||
0885|098|P|chickenpox, measles.||
0885|099|P|   Before having surgery, tell your doctor or dentist about all||
0885|100|P|the products you use (including prescription drugs,||
0885|101|P|nonprescription drugs, and herbal products).||
0885|102|P|   During pregnancy, this medication should be used only when||
0885|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
0885|104|P|   This medication may pass into breast milk. Consult your doctor||
0885|105|P|before breastfeeding.||
0885|106|B|||
0885|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0885|108|I|medications work or increase your risk for serious side effects.||
0885|109|I|This document does not contain all possible drug interactions.||
0885|110|I|Keep a list of all the products you use (including||
0885|111|I|prescription/nonprescription drugs and herbal products) and share||
0885|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
0885|113|I|the dosage of any medicines without your doctor's approval.||
0885|114|I|   Do not use with any other diphenhydramine product applied to||
0885|115|I|the skin or taken by mouth because increased side effects may||
0885|116|I|occur.||
0885|117|B|||
0885|118|O|OVERDOSE:  This product may be harmful if swallowed. If too much||
0885|119|O|of this medication is applied to the skin, wash it off with||
0885|120|O|plenty of soap and water. If someone has overdosed and has||
0885|121|O|serious symptoms such as passing out or trouble breathing, call||
0885|122|O|911. Otherwise, call a poison control center right away. US||
0885|123|O|residents can call 1-800-222-1222. Canada residents can call||
0885|124|O|1-844-764-7669. Symptoms of overdose may include: mental/mood||
0885|125|O|changes, confusion, dry mouth, trouble speaking, trembling||
0885|126|O|hands/feet, seizures.||
0885|127|B|||
0885|128|N|NOTES:  Keep all medical and lab appointments.||
0885|129|B|||
0885|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0885|131|D|If it is near the time of the next dose, skip the missed dose.||
0885|132|D|Use your next dose at the regular time. Do not double the dose to||
0885|133|D|catch up.||
0885|134|B|||
0885|135|R|STORAGE:  Store at room temperature. Different brands of this||
0885|136|R|medication have different storage needs. Check the product||
0885|137|R|package for instructions on how to store your brand, or ask your||
0885|138|R|pharmacist. Some products contain alcohol and are flammable. Keep||
0885|139|R|those products away from heat and open flame. Keep all||
0885|140|R|medications away from children and pets.||
0885|141|R|   Do not flush medications down the toilet or pour them into a||
0885|142|R|drain unless instructed to do so. Properly discard this product||
0885|143|R|when it is expired or no longer needed. Consult your pharmacist||
0885|144|R|or local waste disposal company.||
0885|145|B|||
0885|146|A|Information last revised July 2025.||
0885|147|A|Copyright(c) 2025 First Databank, Inc.||
0885|148|B|||
0886|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0886|002|Z|does NOT have all possible information about this product. This||
0886|003|Z|information does not assure that this product is safe, effective,||
0886|004|Z|or appropriate for you. This information is not individual||
0886|005|Z|medical advice and does not substitute for the advice of your||
0886|006|Z|health care professional. Always ask your health care||
0886|007|Z|professional for complete information about this product and your||
0886|008|Z|specific health needs.||
0886|009|B|||
0886|010|T|PRAMOXINE - TOPICAL||
0886|011|F|(pram-OX-een)||
0886|012|B|||
0886|013|C|COMMON BRAND NAME(S): Caladryl, Tronolane||
0886|014|B|||
0886|015|U|USES:  Pramoxine is used to temporarily relieve itching and pain||
0886|016|U|caused by minor skin irritation such as minor burns/cuts/scrapes,||
0886|017|U|sunburn, eczema, insect bites, cold sores, or rashes from poison||
0886|018|U|ivy, poison oak, or poison sumac. Some products containing||
0886|019|U|pramoxine are also used to temporarily relieve the itching and||
0886|020|U|discomfort from hemorrhoids and certain other problems of the||
0886|021|U|genital/anal area (such as anal fissures, itching around the||
0886|022|U|vagina/rectum). Pramoxine belongs to a class of drugs known as||
0886|023|U|local anesthetics. It works by numbing the skin to block the||
0886|024|U|feelings of pain and itching. This product may also contain other||
0886|025|U|ingredients including skin protectants (such as calamine, zinc||
0886|026|U|acetate, zinc oxide). Read the product package for more||
0886|027|U|information.||
0886|028|U|   Do not use pramoxine for skin irritation in children younger||
0886|029|U|than 2 years or use pramoxine for hemorrhoids or other||
0886|030|U|genital/anal conditions in children younger than 12 years unless||
0886|031|U|directed by the doctor.||
0886|032|U|   If you are self-treating with this medication, it is important||
0886|033|U|to read the package instructions carefully before you start using||
0886|034|U|this product to be sure it is right for you. (See also||
0886|035|U|Precautions section.)||
0886|036|B|||
0886|037|H|HOW TO USE:  This medication is for use only on the skin as||
0886|038|H|directed by your doctor. Do not apply on severely broken skin||
0886|039|H|areas such as open wounds, deep cuts, or serious burns. If you||
0886|040|H|are self-treating, follow all directions on the product package.||
0886|041|H|If you have any questions, ask your doctor or pharmacist.||
0886|042|H|   Gently clean and dry the affected area. If you are using a||
0886|043|H|lotion, spray, or foam product, shake the container well before||
0886|044|H|using as directed on the label. For skin irritation, apply to the||
0886|045|H|affected area usually up to 3 to 4 times a day or as directed by||
0886|046|H|your doctor. For hemorrhoids or other anal conditions, apply the||
0886|047|H|medication to the affected area usually after each bowel movement||
0886|048|H|or up to 4 to 5 times a day, or as directed by your doctor. Do||
0886|049|H|not use this medication inside the rectum. Spray the foam onto a||
0886|050|H|clean tissue and apply to the affected area. If you are using the||
0886|051|H|hemorrhoidal cream, you may use the applicator that comes with||
0886|052|H|it. Clean the applicator after each use.||
0886|053|H|   Wash your hands immediately after use, unless the area being||
0886|054|H|treated includes the hands.||
0886|055|H|   Do not use this product on large areas of the body or use it||
0886|056|H|more often than directed. Do not cover the area with waterproof||
0886|057|H|bandages or plastic, or apply heat unless told to do so by your||
0886|058|H|doctor. Your condition will not improve any faster, and your risk||
0886|059|H|of side effects will increase.||
0886|060|H|   Do not get the product in your eyes, nose, ears, or mouth. If||
0886|061|H|the medication gets in these areas, wipe it off and rinse right||
0886|062|H|away with water.||
0886|063|H|   Stop using this product and tell your doctor if your condition||
0886|064|H|gets worse, if symptoms do not get better within 7 days or last||
0886|065|H|after 7 days of treatment, or if symptoms clear up and return in||
0886|066|H|a few days. If you think you may have a serious medical problem,||
0886|067|H|get medical help right away.||
0886|068|B|||
0886|069|S|SIDE EFFECTS:  Burning or stinging may occur. If either of these||
0886|070|S|effects last or get worse, tell your doctor or pharmacist||
0886|071|S|promptly.||
0886|072|S|   If your doctor has directed you to use this product, remember||
0886|073|S|that your doctor has judged that the benefit to you is greater||
0886|074|S|than the risk of side effects. Many people using this product do||
0886|075|S|not have serious side effects.||
0886|076|S|   A very serious allergic reaction to this drug is rare.||
0886|077|S|However, get medical help right away if you notice any symptoms||
0886|078|S|of a serious allergic reaction, including: rash, itching/swelling||
0886|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0886|080|S|breathing.||
0886|081|S|   This is not a complete list of possible side effects. If you||
0886|082|S|notice other effects not listed above, contact your doctor or||
0886|083|S|pharmacist.||
0886|084|S|   In the US -||
0886|085|S|   Call your doctor for medical advice about side effects. You||
0886|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0886|087|S|www.fda.gov/medwatch.||
0886|088|S|   In Canada - Call your doctor for medical advice about side||
0886|089|S|effects. You may report side effects to Health Canada at||
0886|090|S|1-866-234-2345.||
0886|091|B|||
0886|092|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0886|093|P|pharmacist if you are allergic to pramoxine; or to any of the||
0886|094|P|other ingredients listed on the product package; or if you have||
0886|095|P|any other allergies. This product may contain inactive||
0886|096|P|ingredients, which can cause allergic reactions or other||
0886|097|P|problems. Talk to your pharmacist for more details.||
0886|098|P|   Before using this medication, tell your doctor or pharmacist||
0886|099|P|your medical history, especially of: deep/open/puncture wounds,||
0886|100|P|broken/damaged/blistered skin, animal bites, serious burns.||
0886|101|P|   If you are using this product for hemorrhoids and bleeding||
0886|102|P|from the rectum occurs, stop using it and consult your doctor||
0886|103|P|promptly.||
0886|104|P|   Before having surgery, tell your doctor or dentist about all||
0886|105|P|the products you use (including prescription drugs,||
0886|106|P|nonprescription drugs, and herbal products).||
0886|107|P|   During pregnancy, this medication should be used only when||
0886|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
0886|109|P|   It is unknown if this drug passes into breast milk. Consult||
0886|110|P|your doctor before breastfeeding.||
0886|111|B|||
0886|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0886|113|I|medications work or increase your risk for serious side effects.||
0886|114|I|This document does not contain all possible drug interactions.||
0886|115|I|Keep a list of all the products you use (including||
0886|116|I|prescription/nonprescription drugs and herbal products) and share||
0886|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
0886|118|I|the dosage of any medicines without your doctor's approval.||
0886|119|B|||
0886|120|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0886|121|O|has overdosed and has serious symptoms such as passing out or||
0886|122|O|trouble breathing, call 911. Otherwise, call a poison control||
0886|123|O|center right away. US residents can call 1-800-222-1222. Canada||
0886|124|O|residents can call 1-844-764-7669.||
0886|125|B|||
0886|126|N|NOTES:  Keep all medical and lab appointments.||
0886|127|B|||
0886|128|D|MISSED DOSE:  If you are using this product on a regular schedule||
0886|129|D|and miss a dose, use it as soon as you remember. If it is near||
0886|130|D|the time of the next dose, skip the missed dose. Use your next||
0886|131|D|dose at the regular time. Do not double the dose to catch up.||
0886|132|B|||
0886|133|R|STORAGE:  Store at room temperature. Different products have||
0886|134|R|different storage needs. Check the product package for||
0886|135|R|instructions on how to store it, or ask your pharmacist. Keep all||
0886|136|R|medications away from children and pets.||
0886|137|R|   Do not flush medications down the toilet or pour them into a||
0886|138|R|drain unless instructed to do so. Properly discard this product||
0886|139|R|when it is expired or no longer needed. Consult your pharmacist||
0886|140|R|or local waste disposal company.||
0886|141|B|||
0886|142|A|Information last revised November 2024.||
0886|143|A|Copyright(c) 2025 First Databank, Inc.||
0886|144|B|||
0887|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0887|002|Z|does NOT have all possible information about this product. This||
0887|003|Z|information does not assure that this product is safe, effective,||
0887|004|Z|or appropriate for you. This information is not individual||
0887|005|Z|medical advice and does not substitute for the advice of your||
0887|006|Z|health care professional. Always ask your health care||
0887|007|Z|professional for complete information about this product and your||
0887|008|Z|specific health needs.||
0887|009|B|||
0887|010|T|MULTIVITAMINS/MINERALS/OMEGA-3 FATTY ACIDS - ORAL||
0887|011|B|||
0887|012|W|WARNING:  If your brand of multivitamin contains iron, it is||
0887|013|W|important to keep this product out of reach of children.||
0887|014|W|Accidental overdose of iron-containing products is a leading||
0887|015|W|cause of fatal poisoning in children younger than 6 years. If||
0887|016|W|overdose does occur, get medical help right away or call a poison||
0887|017|W|control center.||
0887|018|B|||
0887|019|U|USES:  This medication contains vitamins, minerals, and fatty||
0887|020|U|acids. It is used to treat or prevent a lack of these nutrients||
0887|021|U|during pregnancy or due to poor diet or certain illnesses.||
0887|022|U|Vitamins, minerals, and fatty acids are important building blocks||
0887|023|U|of the body and help keep you in good health.||
0887|024|U|   This combination product may contain folic acid. Women who are||
0887|025|U|or may become pregnant should maintain adequate levels of folic||
0887|026|U|acid through either diet or supplements to prevent spinal cord||
0887|027|U|birth defects.||
0887|028|U|   Some supplement products have been found to contain possibly||
0887|029|U|harmful impurities/additives. Check with your pharmacist for more||
0887|030|U|details about the brand you use.||
0887|031|U|   The FDA has not reviewed this product for safety or||
0887|032|U|effectiveness. Consult your doctor or pharmacist for more||
0887|033|U|details.||
0887|034|B|||
0887|035|H|HOW TO USE:  Take this medication by mouth, usually once or twice||
0887|036|H|daily or as directed. Follow all directions on the product||
0887|037|H|package, or take as directed by your doctor. Do not take more||
0887|038|H|than the recommended dosage. If you have any questions, ask your||
0887|039|H|doctor or pharmacist.||
0887|040|H|   If you are taking the chewable tablets, chew each tablet well||
0887|041|H|and then swallow.||
0887|042|H|   Take this medication regularly to get the most benefit from||
0887|043|H|it. To help you remember, take it at the same time(s) each day.||
0887|044|B|||
0887|045|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
0887|046|S|occur. These effects are usually temporary and may disappear as||
0887|047|S|your body adjusts to this medication. If any of these effects||
0887|048|S|last or get worse, contact your doctor or pharmacist promptly.||
0887|049|S|   If your doctor has prescribed this medication, remember that||
0887|050|S|your doctor has judged that the benefit to you is greater than||
0887|051|S|the risk of side effects. Many people using this medication do||
0887|052|S|not have serious side effects.||
0887|053|S|   Tell your doctor right away if you have any serious side||
0887|054|S|effects, including: easy bleeding/bruising.||
0887|055|S|   A very serious allergic reaction to this drug is rare.||
0887|056|S|However, get medical help right away if you notice any symptoms||
0887|057|S|of a serious allergic reaction, including: rash, itching/swelling||
0887|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0887|059|S|breathing.||
0887|060|S|   This is not a complete list of possible side effects. If you||
0887|061|S|notice other effects not listed above, contact your doctor or||
0887|062|S|pharmacist.||
0887|063|S|   In the US -||
0887|064|S|   Call your doctor for medical advice about side effects. You||
0887|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0887|066|S|www.fda.gov/medwatch.||
0887|067|S|   In Canada - Call your doctor for medical advice about side||
0887|068|S|effects. You may report side effects to Health Canada at||
0887|069|S|1-866-234-2345.||
0887|070|B|||
0887|071|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0887|072|P|pharmacist if you are allergic to any of its ingredients; or to||
0887|073|P|fish or soy products; or if you have any other allergies. This||
0887|074|P|product may contain inactive ingredients, which can cause||
0887|075|P|allergic reactions or other problems. Talk to your pharmacist for||
0887|076|P|more details.||
0887|077|P|   Before taking this medication, tell your doctor or pharmacist||
0887|078|P|your medical history, especially of: bleeding disorders, kidney||
0887|079|P|problems, liver problems, stomach/intestinal problems (such as||
0887|080|P|ulcer, colitis).||
0887|081|P|   If your brand of multivitamin also contains folic acid, be||
0887|082|P|sure to tell your doctor or pharmacist if you have vitamin B12||
0887|083|P|deficiency (pernicious anemia) before taking it. Folic acid may||
0887|084|P|affect certain lab tests for vitamin B12 deficiency without||
0887|085|P|treating this anemia. Untreated vitamin B12 deficiency may result||
0887|086|P|in serious nerve problems (such as peripheral neuropathy).||
0887|087|P|Consult your doctor or pharmacist for details.||
0887|088|P|   Before having surgery, tell your doctor or dentist about all||
0887|089|P|the products you use (including prescription drugs,||
0887|090|P|nonprescription drugs, and herbal products).||
0887|091|P|   Tell your doctor if you are pregnant before taking this||
0887|092|P|medication.||
0887|093|P|   This medication passes into breast milk. Consult your doctor||
0887|094|P|before breastfeeding.||
0887|095|B|||
0887|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0887|097|I|medications work or increase your risk for serious side effects.||
0887|098|I|This document does not contain all possible drug interactions.||
0887|099|I|Keep a list of all the products you use (including||
0887|100|I|prescription/nonprescription drugs and herbal products) and share||
0887|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0887|102|I|the dosage of any medicines without your doctor's approval.||
0887|103|I|   If your brand of multivitamin also contains calcium, iron,||
0887|104|I|magnesium, or zinc, then it can decrease the absorption of||
0887|105|I|certain drugs, especially if you take them around the same time.||
0887|106|I|These drugs include bisphosphonates (such as alendronate),||
0887|107|I|levodopa, penicillamine, quinolone antibiotics (such as||
0887|108|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
0887|109|I|doxycycline, minocycline), thyroid medications (such as||
0887|110|I|levothyroxine), among others. Ask your doctor or pharmacist how||
0887|111|I|long you should wait between doses of this product and your other||
0887|112|I|medications and to find a dosing schedule that works for all your||
0887|113|I|medications.||
0887|114|B|||
0887|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0887|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0887|117|O|poison control center right away. US residents can call||
0887|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0887|119|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
0887|120|O|diarrhea.||
0887|121|B|||
0887|122|N|NOTES:  Keep all medical and lab appointments.||
0887|123|N|   This product is not a substitute for a proper diet. Remember||
0887|124|N|that it is best to get your vitamins and minerals from healthy||
0887|125|N|foods. Maintain a well-balanced diet and follow any dietary||
0887|126|N|guidelines as directed by your doctor.||
0887|127|B|||
0887|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0887|129|D|remember. If it is near the time of the next dose, skip the||
0887|130|D|missed dose. Take your next dose at the regular time. Do not||
0887|131|D|double the dose to catch up.||
0887|132|B|||
0887|133|R|STORAGE:  Store at room temperature away from light and moisture.||
0887|134|R|Avoid high heat or freezing. Do not store in the bathroom. Keep||
0887|135|R|all medications away from children and pets.||
0887|136|R|   Do not flush medications down the toilet or pour them into a||
0887|137|R|drain unless instructed to do so. Properly discard this product||
0887|138|R|when it is expired or no longer needed. Consult your pharmacist||
0887|139|R|or local waste disposal company.||
0887|140|B|||
0887|141|A|Information last revised October 2025.||
0887|142|A|Copyright(c) 2025 First Databank, Inc.||
0887|143|B|||
0889|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0889|002|Z|does NOT have all possible information about this product. This||
0889|003|Z|information does not assure that this product is safe, effective,||
0889|004|Z|or appropriate for you. This information is not individual||
0889|005|Z|medical advice and does not substitute for the advice of your||
0889|006|Z|health care professional. Always ask your health care||
0889|007|Z|professional for complete information about this product and your||
0889|008|Z|specific health needs.||
0889|009|B|||
0889|010|T|CODEINE/ACETAMINOPHEN/CAFFEINE - ORAL||
0889|011|F|(KOE-deen/a-SEET-a-MIN-oh-fen/KAF-een)||
0889|012|B|||
0889|013|W|WARNING:  Codeine has a risk for abuse and addiction, which can||
0889|014|W|lead to overdose and death. Codeine may also cause severe,||
0889|015|W|possibly fatal, breathing problems. To lower your risk, your||
0889|016|W|doctor should have you take the smallest dose of codeine that||
0889|017|W|works, and take it for the shortest possible time. See also How||
0889|018|W|to Use section for more information about addiction.||
0889|019|W|   Ask your doctor or pharmacist if you should have medication||
0889|020|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0889|021|W|Teach your family or household members about the signs of an||
0889|022|W|opioid overdose and how to treat it.||
0889|023|W|   The risk for severe breathing problems is higher when you||
0889|024|W|start this medication and after a dose increase, or if you take||
0889|025|W|the wrong dose/strength. Taking this medication with alcohol or||
0889|026|W|other drugs that can cause drowsiness or breathing problems may||
0889|027|W|cause very serious side effects, including death. Also, other||
0889|028|W|medications can affect the removal of codeine from your body,||
0889|029|W|which may affect how codeine works. Be sure you know how to take||
0889|030|W|this medication and what other drugs you should avoid taking with||
0889|031|W|it. See also Drug Interactions section. Get medical help right||
0889|032|W|away if any of these very serious side effects occur:||
0889|033|W|slow/shallow breathing, unusual lightheadedness, severe||
0889|034|W|drowsiness/dizziness, difficulty waking up.||
0889|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0889|036|W|or abuse. If someone accidentally swallows this drug, get medical||
0889|037|W|help right away.||
0889|038|W|   One ingredient in this product is acetaminophen. Taking too||
0889|039|W|much acetaminophen may cause serious (possibly fatal) liver||
0889|040|W|disease. Adults should not take more than 4000 milligrams (4||
0889|041|W|grams) of acetaminophen a day. People with liver problems and||
0889|042|W|children should take less acetaminophen. Ask your doctor or||
0889|043|W|pharmacist how much acetaminophen is safe to take.||
0889|044|W|   Do not use with any other drug containing acetaminophen||
0889|045|W|without asking your doctor or pharmacist first. Acetaminophen is||
0889|046|W|in many nonprescription and prescription medications (such as||
0889|047|W|pain/fever drugs or cough-and-cold products). Check the labels on||
0889|048|W|all your medicines to see if they contain acetaminophen, and ask||
0889|049|W|your pharmacist if you are unsure.||
0889|050|W|   Get medical help right away if you take too much acetaminophen||
0889|051|W|(overdose), even if you feel well. Overdose symptoms may include||
0889|052|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
0889|053|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
0889|054|W|   Daily alcohol use, especially when combined with||
0889|055|W|acetaminophen, may damage your liver. Avoid alcohol.||
0889|056|W|   Before using this medication, women of childbearing age should||
0889|057|W|talk with their doctor(s) about the risks and benefits. Tell your||
0889|058|W|doctor if you are pregnant or if you plan to become pregnant.||
0889|059|W|During pregnancy, this medication should be used only when||
0889|060|W|clearly needed. It may slightly increase the risk of birth||
0889|061|W|defects if used during the first two months of pregnancy. Also,||
0889|062|W|using it for a long time or in high doses near the expected||
0889|063|W|delivery date may harm the unborn baby. To lessen the risk, take||
0889|064|W|the smallest effective dose for the shortest possible time.||
0889|065|W|Babies born to mothers who use this drug for a long time may||
0889|066|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0889|067|W|doctor right away if you notice any symptoms in your newborn baby||
0889|068|W|such as crying that doesn't stop, slow/shallow breathing,||
0889|069|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0889|070|W|difficulty gaining weight.||
0889|071|W|   Children younger than 18 years should not use products that||
0889|072|W|contain codeine. Some children are more sensitive to codeine and||
0889|073|W|have had very serious (rarely fatal) breathing problems such as||
0889|074|W|slow/shallow breathing (see also Side Effects section). The risk||
0889|075|W|is greater in children who are obese or have breathing problems,||
0889|076|W|or after certain surgeries (including tonsil/adenoid removal).||
0889|077|W|Talk with your doctor or pharmacist about the risks and benefits||
0889|078|W|of this medication.||
0889|079|B|||
0889|080|U|USES:  See also Warning section.||
0889|081|U|   This combination medication is used to help relieve mild to||
0889|082|U|moderate pain (such as headaches, muscle pain). It contains an||
0889|083|U|opioid pain reliever (codeine), a non-opioid pain reliever||
0889|084|U|(acetaminophen), and caffeine. Codeine works in the brain to||
0889|085|U|change how your body feels and responds to pain. Acetaminophen||
0889|086|U|can also reduce a fever. Caffeine increases pain relief,||
0889|087|U|especially for certain types of headaches.||
0889|088|B|||
0889|089|H|HOW TO USE:  See also Warning section.||
0889|090|H|   Take this medication by mouth as directed by your doctor,||
0889|091|H|usually every 4 to 6 hours as needed for pain. You may take this||
0889|092|H|drug with or without food. If you have nausea, it may help to||
0889|093|H|take this drug with food. Ask your doctor or pharmacist about||
0889|094|H|other ways to decrease nausea (such as lying down for 1 to 2||
0889|095|H|hours with as little head movement as possible).||
0889|096|H|   The dosage is based on your medical condition and response to||
0889|097|H|treatment. Do not increase your dose or use this drug more often||
0889|098|H|or for longer than prescribed because your risk of side effects||
0889|099|H|may increase. Properly stop the medication when so directed.||
0889|100|H|   Pain medications work best if they are used as the first signs||
0889|101|H|of pain occur. If you wait until the pain has worsened, the||
0889|102|H|medication may not work as well.||
0889|103|H|   This product contains caffeine. Avoid drinking large amounts||
0889|104|H|of beverages containing caffeine (coffee, tea, colas), eating||
0889|105|H|large amounts of chocolate, or taking nonprescription products||
0889|106|H|that contain caffeine.||
0889|107|H|   Suddenly stopping this medication may cause withdrawal,||
0889|108|H|especially if you have used it for a long time or in high doses.||
0889|109|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0889|110|H|Tell your doctor or pharmacist right away if you have any||
0889|111|H|withdrawal symptoms such as restlessness, mental/mood changes||
0889|112|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0889|113|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0889|114|H|aches, or sudden changes in behavior.||
0889|115|H|   When this medication is used for a long time, it may not work||
0889|116|H|as well. Talk with your doctor if this medication stops working||
0889|117|H|well.||
0889|118|H|   Though it helps many people, this medication may sometimes||
0889|119|H|cause addiction. This risk may be higher if you have a||
0889|120|H|mental/mood disorder or a substance use disorder (such as overuse||
0889|121|H|of or addiction to drugs/alcohol). Take this medication exactly||
0889|122|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0889|123|H|pharmacist for more details.||
0889|124|H|   Tell your doctor if your pain does not get better or if it||
0889|125|H|gets worse, or if redness/swelling occurs in the area of pain, or||
0889|126|H|if you have new symptoms such as a high fever or new pain, or if||
0889|127|H|you have a headache that doesn't go away.||
0889|128|B|||
0889|129|S|SIDE EFFECTS:  See also Warning section.||
0889|130|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
0889|131|S|drowsiness, headache, increased urination, or trouble sleeping||
0889|132|S|may occur. If any of these effects last or get worse, tell your||
0889|133|S|doctor or pharmacist promptly.||
0889|134|S|   To prevent constipation, eat dietary fiber, drink enough||
0889|135|S|water, and exercise. You may also need to take a laxative. Ask||
0889|136|S|your pharmacist which type of laxative is right for you.||
0889|137|S|   To reduce the risk of dizziness and lightheadedness, get up||
0889|138|S|slowly when rising from a sitting or lying position.||
0889|139|S|   Remember that this medication has been prescribed because your||
0889|140|S|doctor has judged that the benefit to you is greater than the||
0889|141|S|risk of side effects. Many people using this medication do not||
0889|142|S|have serious side effects.||
0889|143|S|   Tell your doctor right away if you have any serious side||
0889|144|S|effects, including: interrupted breathing during sleep (sleep||
0889|145|S|apnea), mental/mood changes (such as irritability, nervousness,||
0889|146|S|anxiety, hallucinations), fast/irregular heartbeat,||
0889|147|S|stomach/abdominal pain, difficulty urinating, vision changes,||
0889|148|S|shaking (tremor), easy bruising/bleeding, signs of your adrenal||
0889|149|S|glands not working well (such as loss of appetite, unusual||
0889|150|S|tiredness, weight loss), trouble swallowing.||
0889|151|S|   Get medical help right away if you have any very serious side||
0889|152|S|effects, including: fainting, seizure.||
0889|153|S|   Codeine is changed into a strong opioid drug (morphine) in||
0889|154|S|your body. In some people, this change happens faster and more||
0889|155|S|completely than usual, which increases the risk of very serious||
0889|156|S|side effects. Get medical help right away if you notice any of||
0889|157|S|the following: slow/shallow breathing, severe||
0889|158|S|drowsiness/difficulty waking up, confusion.||
0889|159|S|   A very serious allergic reaction to this drug is rare.||
0889|160|S|However, get medical help right away if you notice any symptoms||
0889|161|S|of a serious allergic reaction, including: rash, itching/swelling||
0889|162|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0889|163|S|breathing.||
0889|164|S|   This is not a complete list of possible side effects. If you||
0889|165|S|notice other effects not listed above, contact your doctor or||
0889|166|S|pharmacist.||
0889|167|S|   In the US -||
0889|168|S|   Call your doctor for medical advice about side effects. You||
0889|169|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0889|170|S|www.fda.gov/medwatch.||
0889|171|S|   In Canada - Call your doctor for medical advice about side||
0889|172|S|effects. You may report side effects to Health Canada at||
0889|173|S|1-866-234-2345.||
0889|174|B|||
0889|175|P|PRECAUTIONS:  See also Warning section.||
0889|176|P|   Before taking this medication, tell your doctor or pharmacist||
0889|177|P|if you are allergic to codeine, acetaminophen, or caffeine; or to||
0889|178|P|other opioid pain medications (such as morphine); or if you have||
0889|179|P|any other allergies. This product may contain inactive||
0889|180|P|ingredients, which can cause allergic reactions or other||
0889|181|P|problems. Talk to your pharmacist for more details.||
0889|182|P|   Before using this medication, tell your doctor or pharmacist||
0889|183|P|your medical history, especially of: brain disorders (such as||
0889|184|P|head injury, tumor, seizures), breathing problems (such as||
0889|185|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0889|186|P|gallbladder disease, heart problems (such as irregular heartbeat,||
0889|187|P|recent heart attack), kidney disease, liver disease, mental/mood||
0889|188|P|disorders (such as confusion, depression, thoughts of suicide),||
0889|189|P|personal or family history of a substance use disorder (such as||
0889|190|P|overuse of or addiction to drugs/alcohol), obesity,||
0889|191|P|stomach/intestinal problems (such as blockage, constipation,||
0889|192|P|diarrhea due to infection, paralytic ileus), disease of the||
0889|193|P|pancreas (pancreatitis), difficulty urinating (such as due to||
0889|194|P|enlarged prostate).||
0889|195|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0889|196|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0889|197|P|machinery, or do anything that needs alertness until you can do||
0889|198|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0889|199|P|are using marijuana (cannabis).||
0889|200|P|   Before having surgery or certain medical procedures (such as a||
0889|201|P|heart stress test or a procedure to restore a normal heart rhythm||
0889|202|P|if you have an unusually fast heartbeat), tell your doctor or||
0889|203|P|dentist that you use this medication and about all the products||
0889|204|P|you use (including prescription drugs, nonprescription drugs, and||
0889|205|P|herbal products).||
0889|206|P|   Older adults may be more sensitive to the side effects of this||
0889|207|P|drug, especially confusion, dizziness, drowsiness, trouble||
0889|208|P|sleeping, and slow/shallow breathing.||
0889|209|P|   During pregnancy, this medication should be used only when||
0889|210|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0889|211|P|benefits with your doctor.||
0889|212|P|   This medication passes into breast milk and may have||
0889|213|P|undesirable effects on a nursing infant, such as unusual||
0889|214|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
0889|215|P|limpness. Consult your doctor before breastfeeding.||
0889|216|B|||
0889|217|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
0889|218|I|   Drug interactions may change how your medications work or||
0889|219|I|increase your risk for serious side effects. This document does||
0889|220|I|not contain all possible drug interactions. Keep a list of all||
0889|221|I|the products you use (including prescription/nonprescription||
0889|222|I|drugs and herbal products) and share it with your doctor and||
0889|223|I|pharmacist. Do not start, stop, or change the dosage of any||
0889|224|I|medicines without your doctor's approval.||
0889|225|I|   Some products that may interact with this drug include:||
0889|226|I|certain pain medications (mixed opioid agonist-antagonists such||
0889|227|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0889|228|I|samidorphan.||
0889|229|I|   The risk of serious side effects (such as slow/shallow||
0889|230|I|breathing, severe drowsiness/dizziness) may be increased if this||
0889|231|I|medication is taken with other products that may also cause||
0889|232|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0889|233|I|if you are taking other products such as other opioid pain or||
0889|234|I|cough relievers (such as morphine, hydrocodone), alcohol,||
0889|235|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0889|236|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0889|237|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0889|238|I|cetirizine, diphenhydramine).||
0889|239|I|   Check the labels on all your medicines (such as allergy or||
0889|240|I|cough-and-cold products, pain relievers) because they may also||
0889|241|I|contain acetaminophen, caffeine, or ingredients that cause||
0889|242|I|drowsiness. Ask your pharmacist about using those products||
0889|243|I|safely.||
0889|244|I|   Other medications can affect the removal of this product from||
0889|245|I|your body, which may affect how this product works. Examples||
0889|246|I|include azole antifungals (such as ketoconazole), bupropion,||
0889|247|I|fluoxetine, levoketoconazole, macrolide antibiotics (such as||
0889|248|I|erythromycin), paroxetine, quinidine, rifamycins (such as||
0889|249|I|rifabutin, rifampin), ritonavir, certain drugs used to treat||
0889|250|I|seizures (such as carbamazepine, phenytoin), among others.||
0889|251|I|   This medication may interfere with certain medical/lab tests||
0889|252|I|(such as certain urine tests, amylase/lipase levels,||
0889|253|I|dipyridamole-thallium imaging tests), possibly causing false test||
0889|254|I|results. Make sure lab personnel and all your doctors know you||
0889|255|I|use this drug.||
0889|256|B|||
0889|257|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0889|258|O|as passing out or trouble breathing, give them naloxone or||
0889|259|O|nalmefene if available, then call 911. If the person is awake and||
0889|260|O|has no symptoms, call a poison control center right away. US||
0889|261|O|residents can call 1-800-222-1222. Canada residents can call||
0889|262|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0889|263|O|breathing, coma, seizures, nausea, vomiting, loss of appetite,||
0889|264|O|sweating, stomach/abdominal pain, extreme tiredness, yellowing||
0889|265|O|eyes/skin, dark urine.||
0889|266|B|||
0889|267|N|NOTES:  Do not share this medication with others. Sharing it is||
0889|268|N|against the law.||
0889|269|N|   This medication has been prescribed for your current condition||
0889|270|N|only. Do not use it later for another condition unless your||
0889|271|N|doctor directs you to do so. A different medication may be||
0889|272|N|necessary in that case.||
0889|273|B|||
0889|274|D|MISSED DOSE:  Not applicable.||
0889|275|B|||
0889|276|R|STORAGE:  Store at room temperature away from light and moisture.||
0889|277|R|Do not store in the bathroom. Keep all medications away from||
0889|278|R|children and pets.||
0889|279|R|   Do not flush medications down the toilet or pour them into a||
0889|280|R|drain unless instructed to do so. Properly discard this product||
0889|281|R|when it is expired or no longer needed. Consult your pharmacist||
0889|282|R|or local waste disposal company.||
0889|283|B|||
0889|284|A|Information last revised August 2025.||
0889|285|A|Copyright(c) 2025 First Databank, Inc.||
0889|286|B|||
0895|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0895|002|Z|does NOT have all possible information about this product. This||
0895|003|Z|information does not assure that this product is safe, effective,||
0895|004|Z|or appropriate for you. This information is not individual||
0895|005|Z|medical advice and does not substitute for the advice of your||
0895|006|Z|health care professional. Always ask your health care||
0895|007|Z|professional for complete information about this product and your||
0895|008|Z|specific health needs.||
0895|009|B|||
0895|010|T|MESNA - ORAL||
0895|011|F|(MESS-na)||
0895|012|B|||
0895|013|C|COMMON BRAND NAME(S): Mesnex||
0895|014|B|||
0895|015|U|USES:  This medication is used to reduce the risk of bleeding in||
0895|016|U|the bladder (hemorrhagic cystitis), which is a very serious side||
0895|017|U|effect of treatment with a cancer chemotherapy drug called||
0895|018|U|ifosfamide. Mesna helps to protect the lining of the bladder||
0895|019|U|against damage from ifosfamide. The body breaks down ifosfamide||
0895|020|U|to form a product that can harm the bladder, and mesna works by||
0895|021|U|making this product less harmful. However, mesna does not change||
0895|022|U|ifosfamide's anti-cancer effects.||
0895|023|B|||
0895|024|V|OTHER USES:  This section contains uses of this drug that are not||
0895|025|V|listed in the approved professional labeling for the drug but||
0895|026|V|that may be prescribed by your health care professional. Use this||
0895|027|V|drug for a condition that is listed in this section only if it||
0895|028|V|has been so prescribed by your health care professional.||
0895|029|V|   This drug may also be used to reduce the risk of bleeding in||
0895|030|V|the bladder caused by another cancer chemotherapy drug called||
0895|031|V|cyclophosphamide.||
0895|032|B|||
0895|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0895|034|H|from your pharmacist before you start taking mesna and each time||
0895|035|H|you get a refill. If you have any questions, ask your doctor or||
0895|036|H|pharmacist.||
0895|037|H|   Take this medication by mouth. Follow the dosing schedule as||
0895|038|H|directed by your doctor. The dosage is based on your body size||
0895|039|H|and your dose of ifosfamide (or cyclophosphamide).||
0895|040|H|   While taking this medication, drink at least a quart (4 cups||
0895|041|H|or 1 liter) of liquid each day unless directed otherwise by your||
0895|042|H|doctor. Doing so will also help to reduce the bladder side||
0895|043|H|effects from the chemotherapy drug.||
0895|044|H|   Tell your doctor right away if you vomit within 2 hours of||
0895|045|H|taking a dose. Your doctor will determine if you should repeat||
0895|046|H|the dose or receive mesna by injection into a vein.||
0895|047|H|   Mesna is very effective in reducing the risk of hemorrhagic||
0895|048|H|cystitis in most patients. However, it may not work in a small||
0895|049|H|number of patients. Tell your doctor right away if you notice||
0895|050|H|that your urine is pink, red, or bloody.||
0895|051|B|||
0895|052|S|SIDE EFFECTS:  Headache, flushing, dizziness, drowsiness, nausea,||
0895|053|S|vomiting, loss of appetite, diarrhea, constipation, sensitive||
0895|054|S|skin, or flu-like symptoms (such as sore throat, cough, body||
0895|055|S|aches) may occur. If any of these effects last or get worse, tell||
0895|056|S|your doctor or pharmacist promptly.||
0895|057|S|   Remember that this medication has been prescribed because your||
0895|058|S|doctor has judged that the benefit to you is greater than the||
0895|059|S|risk of side effects. Many people using this medication do not||
0895|060|S|have serious side effects.||
0895|061|S|   Tell your doctor right away if you have any serious side||
0895|062|S|effects, including: fast heartbeat, swelling ankles/feet, muscle||
0895|063|S|weakness.||
0895|064|S|   Get medical help right away if you have any very serious side||
0895|065|S|effects, including: chest pain.||
0895|066|S|   A very serious allergic reaction to this drug is rare.||
0895|067|S|However, get medical help right away if you notice any symptoms||
0895|068|S|of a serious allergic reaction, including: fever, swollen lymph||
0895|069|S|nodes, rash, itching/swelling (especially of the||
0895|070|S|face/tongue/throat), severe dizziness, trouble breathing.||
0895|071|S|   This is not a complete list of possible side effects. If you||
0895|072|S|notice other effects not listed above, contact your doctor or||
0895|073|S|pharmacist.||
0895|074|S|   In the US -||
0895|075|S|   Call your doctor for medical advice about side effects. You||
0895|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0895|077|S|www.fda.gov/medwatch.||
0895|078|S|   In Canada - Call your doctor for medical advice about side||
0895|079|S|effects. You may report side effects to Health Canada at||
0895|080|S|1-866-234-2345.||
0895|081|B|||
0895|082|P|PRECAUTIONS:  Before taking mesna, tell your doctor or pharmacist||
0895|083|P|if you are allergic to it; or if you have any other allergies.||
0895|084|P|This product may contain inactive ingredients, which can cause||
0895|085|P|allergic reactions or other problems. Talk to your pharmacist for||
0895|086|P|more details.||
0895|087|P|   Before using this medication, tell your doctor or pharmacist||
0895|088|P|your medical history.||
0895|089|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0895|090|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0895|091|P|machinery, or do anything that needs alertness until you can do||
0895|092|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0895|093|P|are using marijuana (cannabis).||
0895|094|P|   Before having surgery, tell your doctor or dentist about all||
0895|095|P|the products you use (including prescription drugs,||
0895|096|P|nonprescription drugs, and herbal products).||
0895|097|P|   Tell your doctor if you are pregnant or plan to become||
0895|098|P|pregnant. Since mesna is used with a chemotherapy drug, you||
0895|099|P|should not become pregnant during treatment because the||
0895|100|P|chemotherapy drug may harm an unborn baby. Ask about reliable||
0895|101|P|forms of birth control while using this medication and||
0895|102|P|chemotherapy. If you become pregnant, talk to your doctor right||
0895|103|P|away about the risks and benefits of mesna and the chemotherapy||
0895|104|P|drug.||
0895|105|P|   It is unknown if mesna passes into breast milk. Since mesna is||
0895|106|P|given with a chemotherapy drug, breastfeeding is not recommended||
0895|107|P|while using this medication and for 1 week after the last dose of||
0895|108|P|mesna or the chemotherapy drug. Consult your doctor before||
0895|109|P|breastfeeding.||
0895|110|B|||
0895|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0895|112|I|medications work or increase your risk for serious side effects.||
0895|113|I|This document does not contain all possible drug interactions.||
0895|114|I|Keep a list of all the products you use (including||
0895|115|I|prescription/nonprescription drugs and herbal products) and share||
0895|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
0895|117|I|the dosage of any medicines without your doctor's approval.||
0895|118|I|   This medication may interfere with certain lab tests (such as||
0895|119|I|urine ketone test), possibly causing false test results. Make||
0895|120|I|sure lab personnel and all your doctors know you use this drug.||
0895|121|B|||
0895|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0895|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0895|124|O|poison control center right away. US residents can call||
0895|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0895|126|B|||
0895|127|N|NOTES:  Do not share this medication with others.||
0895|128|N|   This medication does not protect you from other side effects||
0895|129|N|of ifosfamide. Consult your doctor or pharmacist for more||
0895|130|N|information on how to manage other side effects.||
0895|131|N|   Small amounts of blood in the urine cannot be seen without a||
0895|132|N|microscope. A lab test to check for blood in your urine should be||
0895|133|N|done before each dose of ifosfamide. Keep all medical and lab||
0895|134|N|appointments. Consult your doctor for more details.||
0895|135|B|||
0895|136|D|MISSED DOSE:  It is important to take each dose of this||
0895|137|D|medication as scheduled. If you miss a dose, take it as soon as||
0895|138|D|you remember and contact your doctor for further instructions. Do||
0895|139|D|not double the dose to catch up.||
0895|140|B|||
0895|141|R|STORAGE:  Store at room temperature away from light and moisture.||
0895|142|R|Do not store in the bathroom. Keep all medications away from||
0895|143|R|children and pets.||
0895|144|R|   Do not flush medications down the toilet or pour them into a||
0895|145|R|drain unless instructed to do so. Properly discard this product||
0895|146|R|when it is expired or no longer needed. Consult your pharmacist||
0895|147|R|or local waste disposal company.||
0895|148|B|||
0895|149|A|Information last revised May 2024.||
0895|150|A|Copyright(c) 2025 First Databank, Inc.||
0895|151|B|||
0896|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0896|002|Z|does NOT have all possible information about this product. This||
0896|003|Z|information does not assure that this product is safe, effective,||
0896|004|Z|or appropriate for you. This information is not individual||
0896|005|Z|medical advice and does not substitute for the advice of your||
0896|006|Z|health care professional. Always ask your health care||
0896|007|Z|professional for complete information about this product and your||
0896|008|Z|specific health needs.||
0896|009|B|||
0896|010|T|SODIUM OXYBATE SOLUTION - ORAL||
0896|011|F|(SO-dee-um OX-eh-bait)||
0896|012|B|||
0896|013|C|COMMON BRAND NAME(S): Xyrem||
0896|014|B|||
0896|015|W|WARNING:  Sodium oxybate is a very powerful central nervous||
0896|016|W|system (CNS) depressant with a high risk of abuse. It may cause||
0896|017|W|slow/shallow breathing or severe drowsiness at recommended doses.||
0896|018|W|It must be used only for the purpose that your doctor prescribes.||
0896|019|W|It is against the law to use this drug for any other purposes.||
0896|020|W|Abuse or misuse of this drug can result in seizures, severe||
0896|021|W|difficulty breathing, loss of consciousness, and even death. It||
0896|022|W|must not be used with alcohol or other CNS depressants (see also||
0896|023|W|Drug Interactions section).||
0896|024|W|   To receive sodium oxybate in the United States, you must||
0896|025|W|understand, agree to, and carefully follow the requirements of||
0896|026|W|the REMS Program for this medication. If you live in Canada or||
0896|027|W|any other country, consult your doctor and pharmacist for your||
0896|028|W|country's regulations.||
0896|029|B|||
0896|030|U|USES:  See also Warning section.||
0896|031|U|   Sodium oxybate is used to treat narcolepsy, a condition that||
0896|032|U|causes severe daytime sleepiness. It can decrease daytime||
0896|033|U|sleepiness and also reduce the number of sudden short attacks of||
0896|034|U|weak/paralyzed muscles (known as cataplexy) that can occur in||
0896|035|U|patients with narcolepsy. This medication is also known as gamma||
0896|036|U|hydroxybutyrate (GHB).||
0896|037|B|||
0896|038|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
0896|039|H|provided by your pharmacist before you start using sodium oxybate||
0896|040|H|and each time you get a refill. If you have any questions, ask||
0896|041|H|your doctor or pharmacist.||
0896|042|H|   Take this medication by mouth at least 2 hours after eating in||
0896|043|H|2 separate doses as directed by your doctor. Prepare your 2 doses||
0896|044|H|as directed. The doses must each be mixed with 2 ounces (60||
0896|045|H|milliliters) of water. Take the first dose at bedtime while in||
0896|046|H|bed. Set an alarm clock to awaken you for the second dose in||
0896|047|H|2-and-a-half hours to 4 hours. Take the second dose while sitting||
0896|048|H|in bed, and turn off the alarm. If you have children or pets in||
0896|049|H|the house, be sure to use the caps that come with the medication||
0896|050|H|cups in the child-resistant position.||
0896|051|H|   The dosage is based on your medical condition, response to||
0896|052|H|treatment, and other medications you may be taking. Children's||
0896|053|H|dosage is also based on weight. Be sure to tell your doctor and||
0896|054|H|pharmacist about all the products you use (including prescription||
0896|055|H|drugs, nonprescription drugs, and herbal products). To reduce||
0896|056|H|your risk of side effects, your doctor may direct you to start||
0896|057|H|this medication at a low dose and gradually increase your dose||
0896|058|H|over 1 to 2 weeks. This process will continue until your doctor||
0896|059|H|has found the right dose for you. Follow your doctor's directions||
0896|060|H|carefully.||
0896|061|H|   Use this medication regularly to get the most benefit from it.||
0896|062|H|To help you remember, take it at the same times each night. Do||
0896|063|H|not increase your dose or use this drug more often or for longer||
0896|064|H|than prescribed. Your condition will not improve any faster, and||
0896|065|H|your risk of side effects will increase.||
0896|066|H|   If you suddenly stop using this medication, you may have||
0896|067|H|withdrawal symptoms (such as anxiety, psychosis, fast heartbeat,||
0896|068|H|trouble sleeping). To help prevent withdrawal, your doctor may||
0896|069|H|lower your dose slowly. Withdrawal is more likely if you have||
0896|070|H|used sodium oxybate solution for a long time or in high doses.||
0896|071|H|Tell your doctor or pharmacist right away if you have withdrawal.||
0896|072|H|   Tell your doctor if your condition lasts or gets worse.||
0896|073|B|||
0896|074|S|SIDE EFFECTS:  See also Warning section.||
0896|075|S|   Drowsiness, dizziness, nausea, vomiting, bedwetting, stomach||
0896|076|S|pain, diarrhea, increased sweating, or headache may occur. If any||
0896|077|S|of these effects last or get worse, tell your doctor or||
0896|078|S|pharmacist promptly.||
0896|079|S|   Remember that this medication has been prescribed because your||
0896|080|S|doctor has judged that the benefit to you is greater than the||
0896|081|S|risk of side effects. Many people using this medication do not||
0896|082|S|have serious side effects.||
0896|083|S|   Tell your doctor right away if you have any serious side||
0896|084|S|effects, including: mental/mood changes (such as confusion,||
0896|085|S|psychosis, hallucinations, agitation, depression, thoughts of||
0896|086|S|suicide), sleepwalking.||
0896|087|S|   Get medical help right away if you have any very serious side||
0896|088|S|effects, including: difficult/slow/shallow breathing (especially||
0896|089|S|during sleep).||
0896|090|S|   A very serious allergic reaction to this drug is rare.||
0896|091|S|However, get medical help right away if you notice any symptoms||
0896|092|S|of a serious allergic reaction, including: rash, itching/swelling||
0896|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0896|094|S|breathing.||
0896|095|S|   This is not a complete list of possible side effects. If you||
0896|096|S|notice other effects not listed above, contact your doctor or||
0896|097|S|pharmacist.||
0896|098|S|   In the US -||
0896|099|S|   Call your doctor for medical advice about side effects. You||
0896|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0896|101|S|www.fda.gov/medwatch.||
0896|102|S|   In Canada - Call your doctor for medical advice about side||
0896|103|S|effects. You may report side effects to Health Canada at||
0896|104|S|1-866-234-2345.||
0896|105|B|||
0896|106|P|PRECAUTIONS:  Before taking sodium oxybate, tell your doctor or||
0896|107|P|pharmacist if you are allergic to it; or if you have any other||
0896|108|P|allergies. This product may contain inactive ingredients, which||
0896|109|P|can cause allergic reactions or other problems. Talk to your||
0896|110|P|pharmacist for more details.||
0896|111|P|   Before using this medication, tell your doctor or pharmacist||
0896|112|P|your medical history, especially of: a certain rare metabolic||
0896|113|P|condition (succinic semialdehyde dehydrogenase deficiency), liver||
0896|114|P|disease, kidney disease, breathing problems (such as sleep apnea,||
0896|115|P|asthma), personal or family history of a substance use disorder||
0896|116|P|(such as overuse of or addiction to drugs/alcohol), heart||
0896|117|P|problems (such as heart failure, high blood pressure),||
0896|118|P|mental/mood problems (such as depression, family/personal history||
0896|119|P|of suicidal thoughts/attempts).||
0896|120|P|   Sleep disorders may decrease your ability to react quickly.||
0896|121|P|Though sodium oxybate helps keep you awake during the day, you||
0896|122|P|still may not be able to safely perform tasks that require||
0896|123|P|alertness (such as driving, flying). This drug may also make you||
0896|124|P|dizzy. Alcohol or marijuana (cannabis) can make you more dizzy.||
0896|125|P|For these reasons, do not drive, use machinery, or do anything||
0896|126|P|that needs alertness until you can do it safely. Always use great||
0896|127|P|care when doing these activities, and avoid them completely||
0896|128|P|during the first 6 hours after you take this medication. Avoid||
0896|129|P|alcoholic beverages because they increase the risk of serious||
0896|130|P|side effects. Talk to your doctor if you are using marijuana||
0896|131|P|(cannabis).||
0896|132|P|   This medication contains sodium. Consult your doctor for more||
0896|133|P|information if you are on a salt-restricted diet or if you have a||
0896|134|P|condition that could be worsened by increased salt intake (such||
0896|135|P|as heart failure, high blood pressure)||
0896|136|P|   Before having surgery, tell your doctor or dentist about all||
0896|137|P|the products you use (including prescription drugs,||
0896|138|P|nonprescription drugs, and herbal products).||
0896|139|P|   Older adults may be more sensitive to the side effects of this||
0896|140|P|drug, especially headaches.||
0896|141|P|   During pregnancy, this medication should be used only when||
0896|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
0896|143|P|   This drug passes into breast milk. Consult your doctor before||
0896|144|P|breastfeeding.||
0896|145|B|||
0896|146|I|DRUG INTERACTIONS:  See also Warning section.||
0896|147|I|   Drug interactions may change how your medications work or||
0896|148|I|increase your risk for serious side effects. This document does||
0896|149|I|not contain all possible drug interactions. Keep a list of all||
0896|150|I|the products you use (including prescription/nonprescription||
0896|151|I|drugs and herbal products) and share it with your doctor and||
0896|152|I|pharmacist. Do not start, stop, or change the dosage of any||
0896|153|I|medicines without your doctor's approval.||
0896|154|I|   The risk of serious side effects (such as slow/shallow||
0896|155|I|breathing, severe drowsiness/dizziness) may be increased if this||
0896|156|I|medication is taken with other products that may also cause||
0896|157|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0896|158|I|if you are using other products such as other opioid pain or||
0896|159|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0896|160|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0896|161|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0896|162|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0896|163|I|cetirizine, diphenhydramine).||
0896|164|I|   Check the labels on all your medicines (such as allergy or||
0896|165|I|cough-and-cold products) because they may contain ingredients||
0896|166|I|that cause drowsiness. Ask your pharmacist about using those||
0896|167|I|products safely.||
0896|168|B|||
0896|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0896|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0896|171|O|poison control center right away. US residents can call||
0896|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0896|173|O|Symptoms of overdose may include: lack of response, slow/shallow||
0896|174|O|breathing, seizures.||
0896|175|B|||
0896|176|N|NOTES:  Do not share this medication with others. Sharing it is||
0896|177|N|against the law.||
0896|178|B|||
0896|179|D|MISSED DOSE:  If you miss your first dose of the night, take it||
0896|180|D|as soon as you remember if it is before bedtime. If it is not at||
0896|181|D|bedtime or if it is your second dose, skip the missed dose. Take||
0896|182|D|your next dose at the regular time. Do not double the dose to||
0896|183|D|catch up.||
0896|184|B|||
0896|185|R|STORAGE:  Store at room temperature. Prepare each dose just||
0896|186|R|before bedtime. Use or properly discard prepared doses within 24||
0896|187|R|hours. Keep all medications away from children and pets.||
0896|188|R|   Do not flush medications down the toilet or pour them into a||
0896|189|R|drain unless instructed to do so. Properly discard this product||
0896|190|R|when it is expired or no longer needed. For more details, read||
0896|191|R|the Medication Guide, or consult your pharmacist or local waste||
0896|192|R|disposal company.||
0896|193|B|||
0896|194|A|Information last revised October 2024.||
0896|195|A|Copyright(c) 2025 First Databank, Inc.||
0896|196|B|||
0897|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0897|002|Z|does NOT have all possible information about this product. This||
0897|003|Z|information does not assure that this product is safe, effective,||
0897|004|Z|or appropriate for you. This information is not individual||
0897|005|Z|medical advice and does not substitute for the advice of your||
0897|006|Z|health care professional. Always ask your health care||
0897|007|Z|professional for complete information about this product and your||
0897|008|Z|specific health needs.||
0897|009|B|||
0897|010|T|NALTREXONE SUSPENSION - INJECTION||
0897|011|F|(nal-TREX-own)||
0897|012|B|||
0897|013|C|COMMON BRAND NAME(S): Vivitrol||
0897|014|B|||
0897|015|U|USES:  This medication is used to treat alcohol abuse. It is used||
0897|016|U|only in people who have been able to stop drinking for some time||
0897|017|U|before starting treatment with naltrexone. You should not be||
0897|018|U|drinking when you start naltrexone. It can help people drink less||
0897|019|U|alcohol or stop drinking altogether. Naltrexone works in the||
0897|020|U|brain to decrease the desire to drink. It does not work like some||
0897|021|U|other treatments for alcohol abuse (such as disulfiram). It will||
0897|022|U|not make you sick when taken with alcohol.||
0897|023|U|   This medication is also used to prevent relapse to opioid||
0897|024|U|abuse, after opioid detoxification. It works by blocking the||
0897|025|U|action of opioids. This medication must not be used in people||
0897|026|U|currently taking opiates, including methadone. Doing so can cause||
0897|027|U|sudden withdrawal symptoms.||
0897|028|U|   Naltrexone belongs to a class of drugs known as opiate||
0897|029|U|antagonists. It is used as part of a complete treatment program||
0897|030|U|for alcohol or opioid abuse (such as counseling, 12-step program,||
0897|031|U|lifestyle changes).||
0897|032|U|   Ask your doctor or pharmacist if you should have medication||
0897|033|U|available to treat opioid overdose (such as naloxone, nalmefene).||
0897|034|U|Teach your family or household members about the signs of an||
0897|035|U|opioid overdose and how to treat it.||
0897|036|B|||
0897|037|H|HOW TO USE:  Read the Medication Guide provided by your||
0897|038|H|pharmacist before you start using naltrexone and each time you||
0897|039|H|get a refill. If you have any questions, ask your doctor or||
0897|040|H|pharmacist.||
0897|041|H|   Before you receive this medication, you should have a urine||
0897|042|H|test to check for recent opiate drug use. Your doctor may give||
0897|043|H|you another medication (naloxone challenge test) to check for||
0897|044|H|opiate use. Do not use alcohol/any opiates for at least 7 days||
0897|045|H|before starting naltrexone. You may need to stop certain opiate||
0897|046|H|drugs (such as methadone) 10 to 14 days before starting||
0897|047|H|naltrexone.||
0897|048|H|   This medication is injected into a muscle in the buttock by a||
0897|049|H|health care professional. It is given as directed by your doctor,||
0897|050|H|usually once a month.||
0897|051|H|   The dosage is based on your medical condition and response to||
0897|052|H|treatment. Your doctor may start you at a lower dose and monitor||
0897|053|H|you for any side effects or withdrawal symptoms before increasing||
0897|054|H|your dose.||
0897|055|H|   Continue your treatment program and use this medication||
0897|056|H|regularly to get the most benefit from it. To help you remember,||
0897|057|H|mark your calendar with a reminder.||
0897|058|H|   Tell your doctor if you start drinking alcohol again or start||
0897|059|H|using drugs.||
0897|060|B|||
0897|061|S|SIDE EFFECTS:  Nausea, headache, dizziness, drowsiness, anxiety,||
0897|062|S|tiredness, and loss of appetite may occur. If you have been using||
0897|063|S|opiates regularly, mild opiate withdrawal symptoms may occur,||
0897|064|S|including abdominal cramps, restlessness, bone/joint pain, muscle||
0897|065|S|aches, and runny nose. If any of these effects last or get worse,||
0897|066|S|tell your doctor or pharmacist promptly.||
0897|067|S|   Pain/redness/swelling/itching/bruising at the injection site||
0897|068|S|may also occur. If any of these effects steadily worsen, or if||
0897|069|S|they last longer than two weeks, tell your doctor or pharmacist||
0897|070|S|right away. Rarely, a severe injection site reaction can cause||
0897|071|S|permanent injury if not treated.||
0897|072|S|   Remember that this medication has been prescribed because your||
0897|073|S|doctor has judged that the benefit to you is greater than the||
0897|074|S|risk of side effects. Many people using this medication do not||
0897|075|S|have serious side effects.||
0897|076|S|   Sudden opiate withdrawal symptoms can occur within minutes||
0897|077|S|after using naltrexone if you are physically addicted to opiates.||
0897|078|S|Tell your doctor right away if any of these withdrawal symptoms||
0897|079|S|occur: vomiting, diarrhea, mental/mood changes (such as anxiety,||
0897|080|S|confusion, extreme sleepiness, visual hallucinations).||
0897|081|S|   Tell your doctor right away if you have any serious side||
0897|082|S|effects, including: fast/irregular heartbeat, depression/rare||
0897|083|S|thoughts of suicide, signs of a serious breathing||
0897|084|S|problem/pneumonia (such as cough, shortness of breath, wheezing),||
0897|085|S|blisters/sores at injection site.||
0897|086|S|   Get medical help right away if you have any very serious side||
0897|087|S|effects, including: chest pain.||
0897|088|S|   Naltrexone may rarely cause serious liver disease. The risk is||
0897|089|S|increased when larger doses are used. Stop using this medication||
0897|090|S|and get medical help right away if you have any symptoms of liver||
0897|091|S|damage, including: dark urine, nausea/vomiting that doesn't stop,||
0897|092|S|loss of appetite, stomach/abdominal pain, yellowing eyes/skin.||
0897|093|S|   A very serious allergic reaction to this drug is rare.||
0897|094|S|However, get medical help right away if you notice any symptoms||
0897|095|S|of a serious allergic reaction, including: rash, itching/swelling||
0897|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0897|097|S|breathing.||
0897|098|S|   This is not a complete list of possible side effects. If you||
0897|099|S|notice other effects not listed above, contact your doctor or||
0897|100|S|pharmacist.||
0897|101|S|   In the US -||
0897|102|S|   Call your doctor for medical advice about side effects. You||
0897|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0897|104|S|www.fda.gov/medwatch.||
0897|105|S|   In Canada - Call your doctor for medical advice about side||
0897|106|S|effects. You may report side effects to Health Canada at||
0897|107|S|1-866-234-2345.||
0897|108|B|||
0897|109|P|PRECAUTIONS:  Before using naltrexone, tell your doctor or||
0897|110|P|pharmacist if you are allergic to it; or if you have any other||
0897|111|P|allergies. This product may contain inactive ingredients, which||
0897|112|P|can cause allergic reactions or other problems. Talk to your||
0897|113|P|pharmacist for more details.||
0897|114|P|   Before using this medication, tell your doctor or pharmacist||
0897|115|P|your medical history, especially of: current or recent use (in||
0897|116|P|the last 7 to 14 days) of any type of opioid drug (such as||
0897|117|P|morphine, methadone, buprenorphine), bleeding problems (such as||
0897|118|P|hemophilia, low platelets), kidney disease, liver problems.||
0897|119|P|   You should carry or wear medical identification stating that||
0897|120|P|you are using this drug so that appropriate treatment can be||
0897|121|P|given in a medical emergency.||
0897|122|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0897|123|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0897|124|P|machinery, or do anything that needs alertness until you can do||
0897|125|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0897|126|P|are using marijuana (cannabis).||
0897|127|P|   After stopping naltrexone treatment or missing a dose of||
0897|128|P|naltrexone, you may be more sensitive to lower doses of opioids,||
0897|129|P|increasing your risk of serious, possibly fatal side effects from||
0897|130|P|the opioid (such as decreased breathing, loss of consciousness).||
0897|131|P|You may also be more sensitive to lower doses of opioids near the||
0897|132|P|end of the month that you received naltrexone treatment.||
0897|133|P|   Before having surgery, tell your doctor or dentist about all||
0897|134|P|the products you use (including prescription drugs,||
0897|135|P|nonprescription drugs, and herbal products).||
0897|136|P|   This medication blocks the effects of opiate drugs (including||
0897|137|P|heroin) and similar drugs (opioids). However, large doses of||
0897|138|P|heroin or opioids can overcome this block. Trying to overcome||
0897|139|P|this block is very dangerous and may cause serious injury, loss||
0897|140|P|of consciousness, and death. Make sure you completely understand||
0897|141|P|and accept the risks and benefits of using this medication.||
0897|142|P|Follow your doctor's instructions closely.||
0897|143|P|   During pregnancy, this medication should be used only when||
0897|144|P|clearly needed. Discuss the risks and benefits with your doctor.||
0897|145|P|   This drug passes into breast milk. Consult your doctor before||
0897|146|P|breastfeeding.||
0897|147|B|||
0897|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0897|149|I|medications work or increase your risk for serious side effects.||
0897|150|I|This document does not contain all possible drug interactions.||
0897|151|I|Keep a list of all the products you use (including||
0897|152|I|prescription/nonprescription drugs and herbal products) and share||
0897|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
0897|154|I|the dosage of any medicines without your doctor's approval.||
0897|155|I|   Some products that may interact with this drug include: "blood||
0897|156|I|thinners" (such as warfarin, enoxaparin), dextromethorphan,||
0897|157|I|diarrhea medication (such as diphenoxylate), opioid pain or cough||
0897|158|I|relievers (such as codeine, hydrocodone).||
0897|159|I|   This medication may interfere with certain lab tests (such as||
0897|160|I|drug tests), possibly causing false test results. Make sure lab||
0897|161|I|personnel and all your doctors know you use this drug.||
0897|162|B|||
0897|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0897|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0897|165|O|poison control center right away. US residents can call||
0897|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0897|167|B|||
0897|168|N|NOTES:  Do not share this medication with others.||
0897|169|N|   Lab and/or medical tests (such as liver function) should be||
0897|170|N|done while you are using this medication. Keep all medical and||
0897|171|N|lab appointments. Consult your doctor for more details.||
0897|172|B|||
0897|173|D|MISSED DOSE:  See also Precautions section.||
0897|174|D|   It is important to get each dose of this medication as||
0897|175|D|scheduled. If you miss a dose, ask your doctor or pharmacist||
0897|176|D|right away for a new dosing schedule.||
0897|177|B|||
0897|178|R|STORAGE:  Not applicable. This medication is given in a clinic or||
0897|179|R|doctor's office and will not be stored at home.||
0897|180|B|||
0897|181|A|Information last revised August 2025.||
0897|182|A|Copyright(c) 2025 First Databank, Inc.||
0897|183|B|||
0900|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0900|002|Z|does NOT have all possible information about this product. This||
0900|003|Z|information does not assure that this product is safe, effective,||
0900|004|Z|or appropriate for you. This information is not individual||
0900|005|Z|medical advice and does not substitute for the advice of your||
0900|006|Z|health care professional. Always ask your health care||
0900|007|Z|professional for complete information about this product and your||
0900|008|Z|specific health needs.||
0900|009|B|||
0900|010|T|CLOBETASOL/EMOLLIENT FOAM - TOPICAL||
0900|011|F|(kloe-BAY-ta-sol/ee-MOL-yunt)||
0900|012|B|||
0900|013|C|COMMON BRAND NAME(S): Olux-E, Tovet||
0900|014|B|||
0900|015|U|USES:  This medication is used to treat a variety of skin||
0900|016|U|conditions (such as psoriasis, eczema, dermatitis, allergies,||
0900|017|U|rash). Clobetasol reduces the swelling, itching, and redness that||
0900|018|U|can occur in these types of conditions. It also can heal the||
0900|019|U|rough, scaly patches on the skin seen with psoriasis. Clobetasol||
0900|020|U|is a very strong (super-high-potency) corticosteroid. This||
0900|021|U|medication also contains emollients. Emollients soften and||
0900|022|U|moisturize the skin, leading to decreased itching and flaking.||
0900|023|U|Emollients also help to protect the skin against irritation.||
0900|024|U|   This medication is not recommended for use in children younger||
0900|025|U|than 12 years.||
0900|026|B|||
0900|027|H|HOW TO USE:  Use this medication on the skin only. Do not use it||
0900|028|H|on the face, groin, or underarms unless directed to do so by your||
0900|029|H|doctor.||
0900|030|H|   Wash and dry your hands before using. Clean and dry the||
0900|031|H|affected area. Shake the can well before each use. Apply a small||
0900|032|H|amount of medication to the affected area and gently rub in as||
0900|033|H|directed by your doctor, usually 2 times daily. Do not bandage,||
0900|034|H|cover, or wrap the area unless directed to do so by your doctor.||
0900|035|H|   After applying the medication, wash your hands unless you are||
0900|036|H|using this medication to treat the hands. When applying this||
0900|037|H|medication near the eyes, avoid getting it in the eyes because||
0900|038|H|doing so may worsen or cause glaucoma. Also, avoid getting this||
0900|039|H|medication in the nose or mouth. If you get the medication in||
0900|040|H|these areas, rinse with plenty of water. If irritation occurs,||
0900|041|H|contact your doctor right away.||
0900|042|H|   Use this medication only for the condition prescribed. Do not||
0900|043|H|use it for longer than 2 weeks in a row or use more than 50 grams||
0900|044|H|a week unless directed to do so by your doctor.||
0900|045|H|   This medication is flammable until dry. Avoid smoking or being||
0900|046|H|near open flames while using the medication and until the||
0900|047|H|medication has dried.||
0900|048|H|   Tell your doctor if your condition lasts or gets worse after 2||
0900|049|H|weeks.||
0900|050|B|||
0900|051|S|SIDE EFFECTS:  Burning, itching, irritation, or dryness may occur||
0900|052|S|when this medication is first applied to the skin. Acne, unusual||
0900|053|S|hair growth, or small red bumps on the skin (folliculitis) may||
0900|054|S|also occur. If any of these effects last or get worse, tell your||
0900|055|S|doctor or pharmacist promptly.||
0900|056|S|   Remember that this medication has been prescribed because your||
0900|057|S|doctor has judged that the benefit to you is greater than the||
0900|058|S|risk of side effects. Many people using this medication do not||
0900|059|S|have serious side effects.||
0900|060|S|   Tell your doctor right away if you have any serious side||
0900|061|S|effects, including: stretch marks, skin thinning/discoloration.||
0900|062|S|   Skin infections can become worse when this medication is used.||
0900|063|S|Tell your doctor promptly if redness, swelling, or irritation||
0900|064|S|does not improve.||
0900|065|S|   Rarely, it is possible this medication will be absorbed from||
0900|066|S|the skin into the bloodstream. This can lead to side effects of||
0900|067|S|too much corticosteroid. These side effects are more likely in||
0900|068|S|children, and in people who use this medication for a long time||
0900|069|S|or over large areas of the skin. Tell your doctor right away if||
0900|070|S|any of the following side effects occur: unusual/extreme||
0900|071|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0900|072|S|thirst/urination, vision problems.||
0900|073|S|   A very serious allergic reaction to this drug is rare.||
0900|074|S|However, get medical help right away if you notice any symptoms||
0900|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0900|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0900|077|S|breathing.||
0900|078|S|   This is not a complete list of possible side effects. If you||
0900|079|S|notice other effects not listed above, contact your doctor or||
0900|080|S|pharmacist.||
0900|081|S|   In the US -||
0900|082|S|   Call your doctor for medical advice about side effects. You||
0900|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0900|084|S|www.fda.gov/medwatch.||
0900|085|S|   In Canada - Call your doctor for medical advice about side||
0900|086|S|effects. You may report side effects to Health Canada at||
0900|087|S|1-866-234-2345.||
0900|088|B|||
0900|089|P|PRECAUTIONS:  Before using clobetasol/emollients, tell your||
0900|090|P|doctor or pharmacist if you are allergic to it; or to other||
0900|091|P|corticosteroids (such as hydrocortisone, prednisone); or if you||
0900|092|P|have any other allergies. This product may contain inactive||
0900|093|P|ingredients, which can cause allergic reactions or other||
0900|094|P|problems. Talk to your pharmacist for more details.||
0900|095|P|   Before using this medication, tell your doctor or pharmacist||
0900|096|P|your medical history, especially of: certain skin conditions||
0900|097|P|(rosacea, perioral dermatitis).||
0900|098|P|   Do not use if there is an infection or sore present in the||
0900|099|P|area to be treated.||
0900|100|P|   Rarely, using corticosteroid medications for a long time or||
0900|101|P|over large areas of skin can make it more difficult for your body||
0900|102|P|to respond to physical stress. Before having surgery or emergency||
0900|103|P|treatment, or if you get a serious illness/injury, tell your||
0900|104|P|doctor or dentist that you are using this medication or have used||
0900|105|P|this medication within the past few months.||
0900|106|P|   Though it is unlikely, this medication may temporarily slow||
0900|107|P|down a child's growth if used for a long time. See the doctor||
0900|108|P|regularly so your child's height can be checked.||
0900|109|P|   During pregnancy, this medication should be used only when||
0900|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
0900|111|P|   It is unknown if this drug passes into breast milk when||
0900|112|P|applied to the skin. Similar medications pass into breast milk||
0900|113|P|when taken by mouth. Consult your doctor before breastfeeding.||
0900|114|B|||
0900|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0900|116|I|medications work or increase your risk for serious side effects.||
0900|117|I|This document does not contain all possible drug interactions.||
0900|118|I|Keep a list of all the products you use (including||
0900|119|I|prescription/nonprescription drugs and herbal products) and share||
0900|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
0900|121|I|the dosage of any medicines without your doctor's approval.||
0900|122|B|||
0900|123|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0900|124|O|has overdosed and has serious symptoms such as passing out or||
0900|125|O|trouble breathing, call 911. Otherwise, call a poison control||
0900|126|O|center right away. US residents can call 1-800-222-1222. Canada||
0900|127|O|residents can call 1-844-764-7669.||
0900|128|B|||
0900|129|N|NOTES:  Do not share this medication with others.||
0900|130|N|   This medication has been prescribed for your current condition||
0900|131|N|only. Do not use it later for other skin problems unless told to||
0900|132|N|do so by your doctor. A different medication may be necessary in||
0900|133|N|those cases.||
0900|134|N|   Lab and/or medical tests (such as adrenal gland function) may||
0900|135|N|be done while you are using this medication, especially if you||
0900|136|N|use this drug for an extended period of time or apply it over||
0900|137|N|large areas of the body. Keep all medical and lab appointments.||
0900|138|N|Consult your doctor for more details.||
0900|139|B|||
0900|140|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0900|141|D|If it is near the time of the next dose, skip the missed dose.||
0900|142|D|Use your next dose at the regular time. Do not double the dose to||
0900|143|D|catch up.||
0900|144|B|||
0900|145|R|STORAGE:  Store at room temperature away from heat and open||
0900|146|R|flame. Do not puncture the can. Keep all medications away from||
0900|147|R|children and pets.||
0900|148|R|   Do not flush medications down the toilet or pour them into a||
0900|149|R|drain unless instructed to do so. Properly discard this product||
0900|150|R|when it is expired or no longer needed. Consult your pharmacist||
0900|151|R|or local waste disposal company.||
0900|152|B|||
0900|153|A|Information last revised July 2025.||
0900|154|A|Copyright(c) 2025 First Databank, Inc.||
0900|155|B|||
0901|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0901|002|Z|does NOT have all possible information about this product. This||
0901|003|Z|information does not assure that this product is safe, effective,||
0901|004|Z|or appropriate for you. This information is not individual||
0901|005|Z|medical advice and does not substitute for the advice of your||
0901|006|Z|health care professional. Always ask your health care||
0901|007|Z|professional for complete information about this product and your||
0901|008|Z|specific health needs.||
0901|009|B|||
0901|010|T|DESMOPRESSIN DISINTEGRATING TABLET - ORAL||
0901|011|F|(dess-mow-PRESS-in)||
0901|012|B|||
0901|013|C|COMMON BRAND NAME(S): Nocdurna||
0901|014|B|||
0901|015|W|WARNING:  Desmopressin can rarely cause a low level of sodium in||
0901|016|W|the blood (hyponatremia), which can be serious or even fatal.||
0901|017|W|Drinking too much liquid, using certain medications (such as||
0901|018|W|"water pills"/diuretics including furosemide, corticosteroids||
0901|019|W|such as prednisone), being 65 years or older, or having certain||
0901|020|W|medical conditions may increase the risk of low sodium in the||
0901|021|W|blood. Lab tests (such as urine tests, sodium blood levels) must||
0901|022|W|be done before you start using this medication and while you are||
0901|023|W|using it. Keep all medical and lab appointments.||
0901|024|W|   Tell your doctor right away if you develop symptoms of low||
0901|025|W|sodium in the blood, such as nausea, vomiting, headache, muscle||
0901|026|W|weakness/cramps, unusual tiredness, unusual drowsiness,||
0901|027|W|dizziness, restlessness, mental/mood changes including||
0901|028|W|confusion/irritability.||
0901|029|W|   Get medical help right away if you have any very serious side||
0901|030|W|effects, including seizure or trouble breathing.||
0901|031|B|||
0901|032|U|USES:  Desmopressin is used to control the amount of urine your||
0901|033|U|kidneys make. Normally, the amount of urine you make is||
0901|034|U|controlled by a certain substance in the body called vasopressin.||
0901|035|U|In people who have "water diabetes" (diabetes insipidus) or||
0901|036|U|certain kinds of head injury or brain surgery, the body does not||
0901|037|U|make enough vasopressin. Desmopressin is a man-made form of||
0901|038|U|vasopressin and is used to replace a low level of vasopressin.||
0901|039|U|This medication helps to control increased thirst and too much||
0901|040|U|urination due to these conditions, and helps prevent dehydration.||
0901|041|U|   Desmopressin is also used by adults who wake up 2 or more||
0901|042|U|times during the night to urinate due to a condition called||
0901|043|U|nocturnal polyuria. It helps reduce how often you wake up at||
0901|044|U|night to urinate.||
0901|045|U|   Desmopressin is also used to treat children who wet the bed at||
0901|046|U|night. It helps decrease the number of times the child urinates||
0901|047|U|and wets the bed.||
0901|048|B|||
0901|049|H|HOW TO USE:  Read the Medication Guide if available from your||
0901|050|H|pharmacist before you start taking desmopressin and each time you||
0901|051|H|get a refill. If you have any questions, ask your doctor or||
0901|052|H|pharmacist.||
0901|053|H|   To take this medication, remove the tablet from the packaging||
0901|054|H|with dry hands and place it under the tongue. Leave the tablet||
0901|055|H|under your tongue until it dissolves. Do not chew or swallow the||
0901|056|H|tablet whole.||
0901|057|H|   For the treatment of diabetes insipidus, take this medication||
0901|058|H|by mouth as directed by your doctor, usually 2 to 3 times a day.||
0901|059|H|   For the treatment of nighttime urination, take this medication||
0901|060|H|by mouth as directed by your doctor, usually once at bedtime.||
0901|061|H|Limit the fluids you drink, especially 1 hour before you take||
0901|062|H|this medication until 8 hours after the dose.||
0901|063|H|   For the treatment of bedwetting, take this medication usually||
0901|064|H|once a day 1 hour before bedtime. Children should limit the||
0901|065|H|fluids they drink after dinner, especially 1 hour before bedtime||
0901|066|H|until the next morning, or at least 8 hours after the dose. If||
0901|067|H|your child wakes up during the night, limit the amount that your||
0901|068|H|child drinks.||
0901|069|H|   Limit drinking water and other fluids while taking||
0901|070|H|desmopressin. Consult your doctor for details. If you find that||
0901|071|H|you are drinking more fluids than directed, tell your doctor||
0901|072|H|right away.||
0901|073|H|   Dosage is based on your medical condition and response to||
0901|074|H|treatment. Do not take more desmopressin or take it more often||
0901|075|H|than prescribed.||
0901|076|H|   Take this medication regularly to get the most benefit from||
0901|077|H|it. To help you remember, take it at the same time(s) each day.||
0901|078|H|   Tell your doctor if your condition does not get better or if||
0901|079|H|this medication stops working well.||
0901|080|B|||
0901|081|S|SIDE EFFECTS:  See also Warning section.||
0901|082|S|   Headache, nausea, upset stomach, or flushing of the face may||
0901|083|S|occur. If any of these effects last or get worse, tell your||
0901|084|S|doctor or pharmacist promptly.||
0901|085|S|   Remember that this medication has been prescribed because your||
0901|086|S|doctor has judged that the benefit to you is greater than the||
0901|087|S|risk of side effects. Many people using this medication do not||
0901|088|S|have serious side effects.||
0901|089|S|   A very serious allergic reaction to this drug is rare.||
0901|090|S|However, get medical help right away if you notice any symptoms||
0901|091|S|of a serious allergic reaction, including: rash, itching/swelling||
0901|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0901|093|S|breathing.||
0901|094|S|   This is not a complete list of possible side effects. If you||
0901|095|S|notice other effects not listed above, contact your doctor or||
0901|096|S|pharmacist.||
0901|097|S|   In the US -||
0901|098|S|   Call your doctor for medical advice about side effects. You||
0901|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0901|100|S|www.fda.gov/medwatch.||
0901|101|S|   In Canada - Call your doctor for medical advice about side||
0901|102|S|effects. You may report side effects to Health Canada at||
0901|103|S|1-866-234-2345.||
0901|104|B|||
0901|105|P|PRECAUTIONS:  Before taking desmopressin, tell your doctor or||
0901|106|P|pharmacist if you are allergic to it; or if you have any other||
0901|107|P|allergies. This product may contain inactive ingredients, which||
0901|108|P|can cause allergic reactions or other problems. Talk to your||
0901|109|P|pharmacist for more details.||
0901|110|P|   Before using this medication, tell your doctor or pharmacist||
0901|111|P|your medical history, especially of: kidney disease, heart||
0901|112|P|problems (such as blocked blood vessels, heart failure), high||
0901|113|P|blood pressure, a low level of sodium in the blood||
0901|114|P|(hyponatremia), conditions that may increase your risk of||
0901|115|P|fluid/mineral imbalance (such as cystic fibrosis, eating||
0901|116|P|disorders, urinary retention), the urge to drink too much water||
0901|117|P|without being thirsty, a certain brain disorder (syndrome of||
0901|118|P|inappropriate antidiuretic hormone secretion), a certain adrenal||
0901|119|P|gland problem (Addison's disease), bleeding/clotting problems.||
0901|120|P|   If you become dehydrated, your doctor will correct that||
0901|121|P|condition first before starting treatment with desmopressin.||
0901|122|P|   Limit alcohol because it can interfere with how well||
0901|123|P|desmopressin works.||
0901|124|P|   Tell the doctor right away if you develop any illness that can||
0901|125|P|cause water/mineral imbalance (including fever, diarrhea,||
0901|126|P|vomiting, infections such as flu) or if you have conditions that||
0901|127|P|require drinking more fluids (for example, exposure to very hot||
0901|128|P|weather, strenuous exercise). The doctor may need to stop or||
0901|129|P|adjust desmopressin treatment.||
0901|130|P|   Before having surgery, tell your doctor or dentist about all||
0901|131|P|the products you use (including prescription drugs,||
0901|132|P|nonprescription drugs, and herbal products).||
0901|133|P|   Children may be more sensitive to the side effects of this||
0901|134|P|drug, especially water/mineral imbalance and a low level of||
0901|135|P|sodium in the blood.||
0901|136|P|   Older adults may be at greater risk for water/mineral||
0901|137|P|imbalance and a low level of sodium in the blood while using this||
0901|138|P|drug.||
0901|139|P|   During pregnancy, this medication should be used only when||
0901|140|P|clearly needed. Discuss the risks and benefits with your doctor.||
0901|141|P|   This medication passes into breast milk. Consult your doctor||
0901|142|P|before breastfeeding.||
0901|143|B|||
0901|144|I|DRUG INTERACTIONS:  See also Warning section.||
0901|145|I|   Drug interactions may change how your medications work or||
0901|146|I|increase your risk for serious side effects. This document does||
0901|147|I|not contain all possible drug interactions. Keep a list of all||
0901|148|I|the products you use (including prescription/nonprescription||
0901|149|I|drugs and herbal products) and share it with your doctor and||
0901|150|I|pharmacist. Do not start, stop, or change the dosage of any||
0901|151|I|medicines without your doctor's approval.||
0901|152|I|   Some products that may interact with this drug are:||
0901|153|I|corticosteroids that are taken by mouth or inhaled (such as||
0901|154|I|fluticasone, prednisone), tolvaptan, "water pills"/diuretics||
0901|155|I|(such as furosemide).||
0901|156|B|||
0901|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0901|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0901|159|O|poison control center right away. US residents can call||
0901|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0901|161|O|Symptoms of overdose may include: headache that is severe or||
0901|162|O|doesn't go away, confusion, drowsiness, sudden weight gain.||
0901|163|B|||
0901|164|N|NOTES:  Do not share this medication with others.||
0901|165|B|||
0901|166|D|MISSED DOSE:  If you take 1 dose daily and miss a dose, take it||
0901|167|D|as soon as you remember. If you do not remember until the next||
0901|168|D|day, skip the missed dose. Take your next dose at the regular||
0901|169|D|time. Do not double the dose to catch up.||
0901|170|D|   If you take more than 1 dose daily and miss a dose, take it as||
0901|171|D|soon as you remember. If it is near the time of the next dose,||
0901|172|D|skip the missed dose. Take your next dose at the regular time. Do||
0901|173|D|not double the dose to catch up.||
0901|174|B|||
0901|175|R|STORAGE:  Store in the original package at room temperature away||
0901|176|R|from light and moisture. Do not store in the bathroom. Keep all||
0901|177|R|medications away from children and pets.||
0901|178|R|   Do not flush medications down the toilet or pour them into a||
0901|179|R|drain unless instructed to do so. Properly discard this product||
0901|180|R|when it is expired or no longer needed. Consult your pharmacist||
0901|181|R|or local waste disposal company.||
0901|182|B|||
0901|183|A|Information last revised May 2024.||
0901|184|A|Copyright(c) 2025 First Databank, Inc.||
0901|185|B|||
0903|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0903|002|Z|does NOT have all possible information about this product. This||
0903|003|Z|information does not assure that this product is safe, effective,||
0903|004|Z|or appropriate for you. This information is not individual||
0903|005|Z|medical advice and does not substitute for the advice of your||
0903|006|Z|health care professional. Always ask your health care||
0903|007|Z|professional for complete information about this product and your||
0903|008|Z|specific health needs.||
0903|009|B|||
0903|010|T|PACLITAXEL PROTEIN-BOUND - INJECTION||
0903|011|F|(pack-lih-TAX-el)||
0903|012|B|||
0903|013|C|COMMON BRAND NAME(S): Abraxane||
0903|014|B|||
0903|015|W|WARNING:  This medication may often cause a serious blood||
0903|016|W|disorder (decreased bone marrow function leading to a low number||
0903|017|W|of white blood cells). This effect can lower your body's ability||
0903|018|W|to fight an infection. Your doctor will monitor you closely and||
0903|019|W|check your blood often during treatment. If your white blood cell||
0903|020|W|count is too low, you should not receive this medication. Tell||
0903|021|W|your doctor right away if you develop any signs of infection||
0903|022|W|(such as sore throat that doesn't go away, fever, chills,||
0903|023|W|painful/difficult urination).||
0903|024|W|   This medication contains a form of paclitaxel that is bound to||
0903|025|W|a human protein called albumin. This product acts differently in||
0903|026|W|the body than other forms of paclitaxel. This product should not||
0903|027|W|be substituted for or used with any other forms of paclitaxel.||
0903|028|B|||
0903|029|U|USES:  This medication is used to treat certain cancers||
0903|030|U|(including breast, lung, and pancreatic cancer). Paclitaxel||
0903|031|U|belongs to a class of drugs known as chemotherapy drugs. It works||
0903|032|U|by slowing or stopping the growth of cancer cells.||
0903|033|B|||
0903|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0903|035|H|from your pharmacist before you start using paclitaxel and each||
0903|036|H|time you receive a dose. If you have any questions, ask your||
0903|037|H|doctor or pharmacist.||
0903|038|H|   This medication is given by injection into a vein by a health||
0903|039|H|care professional. It is given on a schedule as directed by your||
0903|040|H|doctor. The dosage is based on your medical condition, body size,||
0903|041|H|lab tests, and response to treatment.||
0903|042|B|||
0903|043|S|SIDE EFFECTS:  See also Warning section.||
0903|044|S|   Nausea, vomiting, diarrhea, mouth sores, headache,||
0903|045|S|muscle/joint pain, numbness/tingling/burning of the hands/feet,||
0903|046|S|weakness, or dizziness may occur. If any of these effects last or||
0903|047|S|get worse, tell your doctor promptly.||
0903|048|S|   Temporary hair loss may occur. Normal hair growth should||
0903|049|S|return after treatment has ended.||
0903|050|S|   People using this medication may have serious side effects.||
0903|051|S|However, you have been prescribed this drug because your doctor||
0903|052|S|has judged that the benefit to you is greater than the risk of||
0903|053|S|side effects. Careful monitoring by your doctor may decrease your||
0903|054|S|risk.||
0903|055|S|   Tell your doctor right away if you have any serious side||
0903|056|S|effects, including: signs of anemia (such as unusual tiredness,||
0903|057|S|pale skin), easy bruising/bleeding, fast/slow/irregular||
0903|058|S|heartbeat, pain/redness/swelling/weakness of the arms/legs, calf||
0903|059|S|pain/swelling that is warm to the touch, vision changes.||
0903|060|S|   This medication may rarely irritate the vein it is given into||
0903|061|S|or leak out of the vein and irritate the area. These effects may||
0903|062|S|cause redness, pain, swelling, discoloration, or unusual skin||
0903|063|S|reactions at the injection site, either while the drug is given||
0903|064|S|or rarely 7 to 10 days later. If this drug has leaked out of a||
0903|065|S|vein and caused a skin reaction in the past, you may rarely have||
0903|066|S|a skin reaction in that same area when the drug is given again,||
0903|067|S|even when it is given into another area. Tell your doctor right||
0903|068|S|away of any unusual skin/injection site symptoms.||
0903|069|S|   Get medical help right away if you have any very serious side||
0903|070|S|effects, including: chest/jaw/left arm pain, coughing up blood,||
0903|071|S|fainting, weakness on one side of the body, trouble speaking,||
0903|072|S|confusion, sudden severe headache.||
0903|073|S|   A very serious allergic reaction to this drug is rare.||
0903|074|S|However, get medical help right away if you notice any symptoms||
0903|075|S|of a serious allergic reaction, including: rash, itching/swelling||
0903|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0903|077|S|breathing.||
0903|078|S|   This is not a complete list of possible side effects. If you||
0903|079|S|notice other effects not listed above, contact your doctor or||
0903|080|S|pharmacist.||
0903|081|S|   In the US -||
0903|082|S|   Call your doctor for medical advice about side effects. You||
0903|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0903|084|S|www.fda.gov/medwatch.||
0903|085|S|   In Canada - Call your doctor for medical advice about side||
0903|086|S|effects. You may report side effects to Health Canada at||
0903|087|S|1-866-234-2345.||
0903|088|B|||
0903|089|P|PRECAUTIONS:  Before using paclitaxel, tell your doctor or||
0903|090|P|pharmacist if you are allergic to it; or to similar drugs||
0903|091|P|(taxane-type drugs such as docetaxel, cabazitaxel); or to||
0903|092|P|products containing human albumin; or if you have any other||
0903|093|P|allergies. This product may contain inactive ingredients, which||
0903|094|P|can cause allergic reactions or other problems. Talk to your||
0903|095|P|pharmacist for more details.||
0903|096|P|   Before using this medication, tell your doctor or pharmacist||
0903|097|P|your medical history, especially of: blood disorders (such as low||
0903|098|P|white blood cell count), decreased bone marrow function, current||
0903|099|P|infections, heart problems (such as fast/slow/irregular||
0903|100|P|heartbeat), high or low blood pressure, liver disease.||
0903|101|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0903|102|P|can make you more dizzy. Do not drive, use machinery, or do||
0903|103|P|anything that needs alertness until you can do it safely. Limit||
0903|104|P|alcoholic beverages. Talk to your doctor if you are using||
0903|105|P|marijuana (cannabis).||
0903|106|P|   Tell your health care professional that you are using||
0903|107|P|paclitaxel before having any immunizations/vaccinations. Avoid||
0903|108|P|contact with people who have recently received live vaccines||
0903|109|P|(such as flu vaccine inhaled through the nose).||
0903|110|P|   Paclitaxel can make you more likely to get infections or may||
0903|111|P|make current infections worse. Stay away from anyone who has an||
0903|112|P|infection that may easily spread (such as chickenpox, COVID-19,||
0903|113|P|measles, flu). Talk to your doctor if you have been exposed to an||
0903|114|P|infection or for more details.||
0903|115|P|   To lower the chance of getting cut, bruised, or injured, use||
0903|116|P|caution with sharp objects like safety razors and nail cutters,||
0903|117|P|and avoid activities such as contact sports.||
0903|118|P|   Before having surgery, tell your doctor or dentist about all||
0903|119|P|the products you use (including prescription drugs,||
0903|120|P|nonprescription drugs, and herbal products).||
0903|121|P|   This medication is made from human blood. Even though the||
0903|122|P|blood is carefully tested, and this medication goes through a||
0903|123|P|special manufacturing process, there is an extremely small chance||
0903|124|P|that you may get infections from the medication (for example,||
0903|125|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
0903|126|P|more information.||
0903|127|P|   Older adults may be more sensitive to the side effects of this||
0903|128|P|drug.||
0903|129|P|   Tell your doctor if you are pregnant or plan to become||
0903|130|P|pregnant. You should not become pregnant while using paclitaxel.||
0903|131|P|Paclitaxel may harm an unborn baby. Your doctor should order a||
0903|132|P|pregnancy test before you start this medication. Women using this||
0903|133|P|medication should ask about reliable forms of birth control||
0903|134|P|during treatment and for at least 6 months after the last dose.||
0903|135|P|Men using this medication should ask about reliable forms of||
0903|136|P|birth control during treatment and for some time after the last||
0903|137|P|dose. If you or your partner becomes pregnant, talk to your||
0903|138|P|doctor right away about the risks and benefits of this||
0903|139|P|medication.||
0903|140|P|   It is unknown if this drug passes into breast milk. Because of||
0903|141|P|the possible risk to the infant, breastfeeding is not recommended||
0903|142|P|while using this drug and for 2 weeks after the last dose.||
0903|143|P|Consult your doctor before breastfeeding.||
0903|144|B|||
0903|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0903|146|I|medications work or increase your risk for serious side effects.||
0903|147|I|This document does not contain all possible drug interactions.||
0903|148|I|Keep a list of all the products you use (including||
0903|149|I|prescription/nonprescription drugs and herbal products) and share||
0903|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
0903|151|I|the dosage of any medicines without your doctor's approval.||
0903|152|B|||
0903|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0903|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0903|155|O|poison control center right away. US residents can call||
0903|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0903|157|B|||
0903|158|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
0903|159|N|should be done while you are using this medication. Keep all||
0903|160|N|medical and lab appointments. Consult your doctor for more||
0903|161|N|details.||
0903|162|B|||
0903|163|D|MISSED DOSE:  It is important to get each dose of this medication||
0903|164|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0903|165|D|right away for a new dosing schedule.||
0903|166|B|||
0903|167|R|STORAGE:  Not applicable. This medication is given in a clinic||
0903|168|R|and will not be stored at home.||
0903|169|B|||
0903|170|M|MEDICAL ALERT:  Your condition can cause complications in a||
0903|171|M|medical emergency. For information about enrolling in MedicAlert,||
0903|172|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0903|173|B|||
0903|174|A|Information last revised April 2025.||
0903|175|A|Copyright(c) 2025 First Databank, Inc.||
0903|176|B|||
0904|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0904|002|Z|does NOT have all possible information about this product. This||
0904|003|Z|information does not assure that this product is safe, effective,||
0904|004|Z|or appropriate for you. This information is not individual||
0904|005|Z|medical advice and does not substitute for the advice of your||
0904|006|Z|health care professional. Always ask your health care||
0904|007|Z|professional for complete information about this product and your||
0904|008|Z|specific health needs.||
0904|009|B|||
0904|010|T|FLUDARABINE - ORAL||
0904|011|F|(flew-DARE-uh-bean)||
0904|012|B|||
0904|013|C|COMMON BRAND NAME(S): Oforta||
0904|014|B|||
0904|015|U|USES:  This medication is used to treat leukemia. It works by||
0904|016|U|slowing or stopping the growth of cancer cells.||
0904|017|B|||
0904|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0904|019|H|from your pharmacist before you start taking fludarabine and each||
0904|020|H|time you get a refill. If you have any questions, ask your doctor||
0904|021|H|or pharmacist.||
0904|022|H|   Take this medication by mouth with or without food as directed||
0904|023|H|by your doctor, usually once a day for 5 days in a row. This||
0904|024|H|5-day cycle may be repeated after 28 days, usually for up to 6||
0904|025|H|cycles. Swallow the tablet(s) whole with a glass of water. Do not||
0904|026|H|break, crush, or chew the tablets.||
0904|027|H|   Dosage is based on your medical condition, body size, and||
0904|028|H|response to treatment. Your doctor will check your blood counts||
0904|029|H|to make sure you can receive your next cycle. Keep all||
0904|030|H|medical/lab appointments.||
0904|031|H|   Do not increase your dose or take this medication more often||
0904|032|H|than prescribed. Your condition will not improve any faster, and||
0904|033|H|the risk of serious side effects may be increased.||
0904|034|H|   Since this drug can be absorbed through the skin and lungs,||
0904|035|H|women who are pregnant or who may become pregnant should not||
0904|036|H|handle this medication or breathe the dust from the tablets.||
0904|037|B|||
0904|038|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, tiredness, and loss of||
0904|039|S|appetite may occur. Nausea and vomiting can be severe. In some||
0904|040|S|cases, your doctor may prescribe medication to prevent or relieve||
0904|041|S|nausea and vomiting. Eating several small meals, not eating||
0904|042|S|before treatment, or limiting activity may help lessen some of||
0904|043|S|these effects. If these effects last or get worse, tell your||
0904|044|S|doctor or pharmacist promptly.||
0904|045|S|   Many people using this medication may have serious side||
0904|046|S|effects. However, you have been prescribed this drug because your||
0904|047|S|doctor has judged that the benefit to you is greater than the||
0904|048|S|risk of side effects. Careful monitoring by your doctor may||
0904|049|S|decrease your risk.||
0904|050|S|   Pain or sores in the mouth and throat may occur. Brush your||
0904|051|S|teeth gently/carefully, avoid using mouthwash that contains||
0904|052|S|alcohol, and rinse your mouth often with cool water mixed with||
0904|053|S|baking soda or salt. It may also be best to eat soft, moist||
0904|054|S|foods.||
0904|055|S|   Tell your doctor right away if you have any serious side||
0904|056|S|effects, including: easy bleeding/bruising, fast/irregular||
0904|057|S|heartbeat, swelling ankles/feet.||
0904|058|S|   Fludarabine may rarely cause severe (sometimes fatal) central||
0904|059|S|nervous system problems. Symptoms may not occur until weeks after||
0904|060|S|your last treatment. Tell your doctor right away if you notice||
0904|061|S|any vision changes, seizures, agitation, confusion, or||
0904|062|S|numbness/tingling.||
0904|063|S|   This medication may lower your ability to fight infections.||
0904|064|S|This may make you more likely to get a serious (rarely fatal)||
0904|065|S|infection or make any infection you have worse. Tell your doctor||
0904|066|S|right away if you have any signs of infection (such as sore||
0904|067|S|throat that doesn't go away, fever, chills).||
0904|068|S|   Fludarabine sometimes causes side effects due to the rapid||
0904|069|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
0904|070|S|risk, your doctor may add a medication and tell you to drink||
0904|071|S|plenty of fluids. Tell your doctor right away if you have||
0904|072|S|symptoms such as: low back/side pain (flank pain), signs of||
0904|073|S|kidney problems (such as painful urination, pink/bloody urine,||
0904|074|S|change in the amount of urine), muscle spasms/weakness.||
0904|075|S|   Get medical help right away if you have any very serious side||
0904|076|S|effects, including: cough that doesn't go away,||
0904|077|S|bloody/black/tarry stool, coughing up blood, painful/difficult||
0904|078|S|breathing, chest pain.||
0904|079|S|   A very serious allergic reaction to this drug is rare.||
0904|080|S|However, get medical help right away if you notice any symptoms||
0904|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0904|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0904|083|S|breathing.||
0904|084|S|   This is not a complete list of possible side effects. If you||
0904|085|S|notice other effects not listed above, contact your doctor or||
0904|086|S|pharmacist.||
0904|087|S|   In the US -||
0904|088|S|   Call your doctor for medical advice about side effects. You||
0904|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0904|090|S|www.fda.gov/medwatch.||
0904|091|S|   In Canada - Call your doctor for medical advice about side||
0904|092|S|effects. You may report side effects to Health Canada at||
0904|093|S|1-866-234-2345.||
0904|094|B|||
0904|095|P|PRECAUTIONS:  Before using fludarabine, tell your doctor or||
0904|096|P|pharmacist if you are allergic to it; or if you have any other||
0904|097|P|allergies. This product may contain inactive ingredients, which||
0904|098|P|can cause allergic reactions or other problems. Talk to your||
0904|099|P|pharmacist for more details.||
0904|100|P|   Before using this medication, tell your doctor or pharmacist||
0904|101|P|your medical history, especially of: current infections, certain||
0904|102|P|infections (opportunistic infections such as fungal infections),||
0904|103|P|certain virus conditions (herpes, chickenpox), blood disorders||
0904|104|P|(such as hemolytic anemia, clotting problems), immune system||
0904|105|P|problems, kidney problems, liver disease, skin cancer.||
0904|106|P|   Tell your health care professional that you are using||
0904|107|P|fludarabine before having any immunizations/vaccinations. Avoid||
0904|108|P|contact with people who have recently received live vaccines||
0904|109|P|(such as flu vaccine inhaled through the nose).||
0904|110|P|   Fludarabine can make you more likely to get infections or may||
0904|111|P|make current infections worse. Stay away from anyone who has an||
0904|112|P|infection that may easily spread (such as chickenpox, COVID-19,||
0904|113|P|measles, flu). Talk to your doctor if you have been exposed to an||
0904|114|P|infection or for more details.||
0904|115|P|   To lower your chance of getting cut, bruised, or injured, use||
0904|116|P|caution with sharp objects like razors and nail cutters, and||
0904|117|P|avoid activities such as contact sports.||
0904|118|P|   Before having surgery, tell your doctor or dentist about all||
0904|119|P|the products you use (including prescription drugs,||
0904|120|P|nonprescription drugs, and herbal products).||
0904|121|P|   Before receiving any blood transfusions, tell your doctor that||
0904|122|P|you are taking/have taken fludarabine.||
0904|123|P|   Older adults may be at greater risk for side effects (such as||
0904|124|P|infection, bleeding) while using this drug.||
0904|125|P|   Tell your doctor if you are pregnant or plan to become||
0904|126|P|pregnant. You should not become pregnant while using fludarabine.||
0904|127|P|Fludarabine may harm an unborn baby. Men and women using this||
0904|128|P|medication should ask about reliable forms of birth control||
0904|129|P|during treatment and for 6 months after the last dose. If you or||
0904|130|P|your partner becomes pregnant, talk to your doctor right away||
0904|131|P|about the risks and benefits of this medication.||
0904|132|P|   It is unknown if this medication passes into breast milk.||
0904|133|P|Because of the possible risk to the infant, breastfeeding is not||
0904|134|P|recommended while using this medication. Consult your doctor||
0904|135|P|before breastfeeding.||
0904|136|B|||
0904|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0904|138|I|medications work or increase your risk for serious side effects.||
0904|139|I|This document does not contain all possible drug interactions.||
0904|140|I|Keep a list of all the products you use (including||
0904|141|I|prescription/nonprescription drugs and herbal products) and share||
0904|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
0904|143|I|the dosage of any medicines without your doctor's approval.||
0904|144|I|   Some products that may interact with this drug are: "blood||
0904|145|I|thinners" (such as warfarin, enoxaparin), dipyridamole,||
0904|146|I|pentostatin, other drugs that weaken the immune system/increase||
0904|147|I|the risk of infection (such as natalizumab, rituximab),||
0904|148|I|salicylates/NSAIDs (such as aspirin, ibuprofen, naproxen).||
0904|149|I|   Check all prescription and nonprescription medicine labels||
0904|150|I|carefully since many contain pain relievers/fever reducers||
0904|151|I|(NSAIDs such as ibuprofen, naproxen, and aspirin) that can||
0904|152|I|increase your risk of bleeding. However, if your doctor has told||
0904|153|I|you to take low-dose aspirin to prevent heart attack or stroke||
0904|154|I|(usually 81-162 milligrams a day), you should keep taking the||
0904|155|I|aspirin unless your doctor tells you not to. Ask your doctor or||
0904|156|I|pharmacist for more details.||
0904|157|B|||
0904|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0904|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0904|160|O|poison control center right away. US residents can call||
0904|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0904|162|B|||
0904|163|N|NOTES:  Do not share this medication with others.||
0904|164|N|   Lab and/or medical tests (such as complete blood count, kidney||
0904|165|N|function) should be done while you are taking this medication.||
0904|166|N|Keep all medical and lab appointments. Consult your doctor for||
0904|167|N|more details.||
0904|168|B|||
0904|169|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0904|170|D|remember. If it is near the time of the next dose, skip the||
0904|171|D|missed dose. Take your next dose at the regular time. Do not||
0904|172|D|double the dose to catch up.||
0904|173|B|||
0904|174|R|STORAGE:  Store at room temperature away from light and moisture.||
0904|175|R|Do not freeze. Do not store in the bathroom. Keep all medications||
0904|176|R|away from children and pets.||
0904|177|R|   Do not flush medications down the toilet or pour them into a||
0904|178|R|drain unless instructed to do so. Properly discard this product||
0904|179|R|when it is expired or no longer needed. Consult your pharmacist||
0904|180|R|or local waste disposal company.||
0904|181|B|||
0904|182|M|MEDICAL ALERT:  Your condition can cause complications in a||
0904|183|M|medical emergency. For information about enrolling in MedicAlert,||
0904|184|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0904|185|B|||
0904|186|A|Information last revised April 2025.||
0904|187|A|Copyright(c) 2025 First Databank, Inc.||
0904|188|B|||
0905|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0905|002|Z|does NOT have all possible information about this product. This||
0905|003|Z|information does not assure that this product is safe, effective,||
0905|004|Z|or appropriate for you. This information is not individual||
0905|005|Z|medical advice and does not substitute for the advice of your||
0905|006|Z|health care professional. Always ask your health care||
0905|007|Z|professional for complete information about this product and your||
0905|008|Z|specific health needs.||
0905|009|B|||
0905|010|T|ZUCLOPENTHIXOL - ORAL||
0905|011|F|(zoo-kloh-pen-THICKS-ohl)||
0905|012|B|||
0905|013|W|WARNING:  This medication may rarely cause a serious, possibly||
0905|014|W|fatal condition called neuroleptic malignant syndrome (NMS). Get||
0905|015|W|medical help right away if you have any of the following||
0905|016|W|symptoms: fever, muscle stiffness/pain/tenderness/weakness,||
0905|017|W|severe tiredness, severe confusion, sweating, fast/irregular||
0905|018|W|heartbeat, dark urine, signs of kidney problems (such as change||
0905|019|W|in the amount of urine).||
0905|020|W|   There may be a slightly increased risk of serious, possibly||
0905|021|W|fatal side effects (such as heart failure, fast/irregular||
0905|022|W|heartbeat, pneumonia) when this medication is used by older||
0905|023|W|adults with dementia. This medication is not approved for the||
0905|024|W|treatment of dementia-related behavior problems. Discuss the||
0905|025|W|risks and benefits of this medication, as well as other effective||
0905|026|W|and possibly safer treatments for dementia-related behavior||
0905|027|W|problems, with the doctor.||
0905|028|B|||
0905|029|U|USES:  This medication is used to treat a certain mental/mood||
0905|030|U|disorder (schizophrenia). Zuclopenthixol belongs to a class of||
0905|031|U|drugs known as antipsychotics. It works by helping to restore the||
0905|032|U|balance of certain natural substances in the brain.||
0905|033|B|||
0905|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0905|035|H|from your pharmacist before you start taking zuclopenthixol and||
0905|036|H|each time you get a refill. If you have any questions, ask your||
0905|037|H|doctor or pharmacist.||
0905|038|H|   Take this medication by mouth with or without food as directed||
0905|039|H|by your doctor. Swallow the tablets whole with a glass of water.||
0905|040|H|Your doctor may direct you to take a low dose at first, gradually||
0905|041|H|increasing the dose to lower the chance of side effects such as||
0905|042|H|drowsiness. Your doctor will adjust your dose to find the best||
0905|043|H|dose for you. When you first start the medication, your doctor||
0905|044|H|may direct you to divide your dose and take the drug 2 to 3 times||
0905|045|H|a day. After you have been taking the medication for some time,||
0905|046|H|your doctor may direct you to take your medication as a single||
0905|047|H|dose, usually once daily at bedtime. Follow your doctor's||
0905|048|H|directions carefully.||
0905|049|H|   The dosage is based on your medical condition and response to||
0905|050|H|treatment. Use this medication regularly in order to get the most||
0905|051|H|benefit from it. To help you remember, use it at the same time(s)||
0905|052|H|each day.||
0905|053|H|   Do not stop taking this medication without consulting your||
0905|054|H|doctor. Some conditions may become worse when the drug is||
0905|055|H|suddenly stopped. Your dose may need to be gradually reduced.||
0905|056|H|   This medication does not work right away. It may take up to 1||
0905|057|H|to 2 weeks before you experience the full benefits. Tell your||
0905|058|H|doctor if your symptoms do not get better or if they get worse.||
0905|059|B|||
0905|060|S|SIDE EFFECTS:  See also Warning section.||
0905|061|S|   Dizziness, lightheadedness, drowsiness, constipation,||
0905|062|S|headache, dry mouth, blurred vision, difficulty urinating, and||
0905|063|S|tiredness may occur. If these effects last or get worse, tell||
0905|064|S|your doctor or pharmacist promptly.||
0905|065|S|   Dizziness and lightheadedness can increase the risk of||
0905|066|S|falling. Get up slowly when rising from a sitting or lying||
0905|067|S|position.||
0905|068|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0905|069|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0905|070|S|substitute.||
0905|071|S|   Tell your doctor right away if any of these side effects||
0905|072|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
0905|073|S|mask-like expression of the face, drooling/trouble swallowing, or||
0905|074|S|shuffling walk. Your doctor may prescribe another medication to||
0905|075|S|decrease these side effects.||
0905|076|S|   Remember that this medication has been prescribed because your||
0905|077|S|doctor has judged that the benefit to you is greater than the||
0905|078|S|risk of side effects. Many people using this medication do not||
0905|079|S|have serious side effects.||
0905|080|S|   In rare cases, zuclopenthixol may increase your level of a||
0905|081|S|certain substance made by the body (prolactin). For females, this||
0905|082|S|increase in prolactin may result in unwanted breast milk,||
0905|083|S|missed/stopped periods, or difficulty becoming pregnant. For||
0905|084|S|males, it may result in decreased sexual ability, inability to||
0905|085|S|produce sperm, or enlarged breasts. If you develop any of these||
0905|086|S|symptoms, tell your doctor right away.||
0905|087|S|   Rarely, males may have a painful or prolonged erection lasting||
0905|088|S|4 or more hours. If this occurs, stop using this drug and get||
0905|089|S|medical help right away, or permanent problems could occur.||
0905|090|S|   This medication may rarely cause a condition known as tardive||
0905|091|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0905|092|S|your doctor right away if you develop any uncontrollable||
0905|093|S|facial/muscle twitching/movements such as tongue thrusting,||
0905|094|S|chewing movements, unusual movements of the mouth/lips, or||
0905|095|S|shaking.||
0905|096|S|   Tell your doctor right away if you have any serious side||
0905|097|S|effects, including: nausea/vomiting that doesn't stop,||
0905|098|S|stomach/abdominal pain, yellowing eyes/skin.||
0905|099|S|   Get medical help right away if you have any very serious side||
0905|100|S|effects, including: slow heartbeat, chest pain, severe dizziness,||
0905|101|S|fainting, seizures.||
0905|102|S|   A very serious allergic reaction to this product is rare.||
0905|103|S|However, get medical help right away if you notice any symptoms||
0905|104|S|of a serious allergic reaction, including: rash, itching/swelling||
0905|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0905|106|S|breathing.||
0905|107|S|   This is not a complete list of possible side effects. If you||
0905|108|S|notice other effects not listed above, contact your doctor or||
0905|109|S|pharmacist.||
0905|110|S|   In the US -||
0905|111|S|   Call your doctor for medical advice about side effects. You||
0905|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0905|113|S|www.fda.gov/medwatch.||
0905|114|S|   In Canada - Call your doctor for medical advice about side||
0905|115|S|effects. You may report side effects to Health Canada at||
0905|116|S|1-866-234-2345.||
0905|117|B|||
0905|118|P|PRECAUTIONS:  Before taking zuclopenthixol, tell your doctor or||
0905|119|P|pharmacist if you are allergic to it; or if you have any other||
0905|120|P|allergies. This product may contain inactive ingredients, which||
0905|121|P|can cause allergic reactions or other problems. Talk to your||
0905|122|P|pharmacist for more details.||
0905|123|P|   Before using this medication, tell your doctor or pharmacist||
0905|124|P|your medical history, especially of: blood problems (such as low||
0905|125|P|number of red cells, white cells, or platelets), brain||
0905|126|P|injury/tumor, narrow-angle glaucoma, a certain adrenal gland||
0905|127|P|tumor (pheochromocytoma), breast cancer, breathing problems (such||
0905|128|P|as asthma, bronchitis), slowed gut movement (such as chronic||
0905|129|P|constipation, ileus, blockage), heart problems (such as angina,||
0905|130|P|irregular heartbeat), kidney disease, liver disease, certain||
0905|131|P|muscle problem (myasthenia gravis), neuroleptic malignant||
0905|132|P|syndrome, Parkinson's disease, pituitary tumor, regular/heavy use||
0905|133|P|of alcohol/sedatives, overactive thyroid (hyperthyroidism),||
0905|134|P|seizures, difficulty urinating (such as due to prostate||
0905|135|P|problems).||
0905|136|P|   Zuclopenthixol may cause a condition that affects the heart||
0905|137|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0905|138|P|serious (rarely fatal) fast/irregular heartbeat and other||
0905|139|P|symptoms (such as severe dizziness, fainting) that need medical||
0905|140|P|attention right away.||
0905|141|P|   The risk of QT prolongation may be increased if you have||
0905|142|P|certain medical conditions or are taking other drugs that may||
0905|143|P|cause QT prolongation. Before using zuclopenthixol, tell your||
0905|144|P|doctor or pharmacist of all the drugs you take and if you have||
0905|145|P|any of the following conditions: certain heart problems (heart||
0905|146|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0905|147|P|history of certain heart problems (QT prolongation in the EKG,||
0905|148|P|sudden cardiac death).||
0905|149|P|   Low levels of potassium or magnesium in the blood may also||
0905|150|P|increase your risk of QT prolongation. This risk may increase if||
0905|151|P|you use certain drugs (such as diuretics/"water pills") or if you||
0905|152|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0905|153|P|Talk to your doctor about using zuclopenthixol safely.||
0905|154|P|   This drug may make you dizzy or drowsy or blur your vision.||
0905|155|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0905|156|P|drowsy. Do not drive, use machinery, or do anything that needs||
0905|157|P|alertness or clear vision until you can do it safely. Limit||
0905|158|P|alcoholic beverages. Talk to your doctor if you are using||
0905|159|P|marijuana (cannabis).||
0905|160|P|   Before having procedures with injected dye (such as certain||
0905|161|P|X-ray procedures) or surgery, tell your doctor, radiologist, or||
0905|162|P|dentist that you are taking zuclopenthixol.||
0905|163|P|   This medication may make you sweat less, making you more||
0905|164|P|likely to get heat stroke. Avoid doing things that may cause you||
0905|165|P|to overheat, such as hard work or exercise in hot weather, or||
0905|166|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0905|167|P|and dress lightly. If you overheat, quickly look for a place to||
0905|168|P|cool down and rest. Get medical help right away if you have a||
0905|169|P|fever that does not go away, mental/mood changes, headache, or||
0905|170|P|dizziness.||
0905|171|P|   This medication may make you more sensitive to the sun. Limit||
0905|172|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0905|173|P|sunscreen and wear protective clothing when outdoors. Tell your||
0905|174|P|doctor right away if you get sunburned or have skin||
0905|175|P|blisters/redness.||
0905|176|P|   Older adults may be more sensitive to the side effects of this||
0905|177|P|drug, especially drowsiness, dizziness, lightheadedness,||
0905|178|P|difficulty urinating, and heart effects such as QT prolongation||
0905|179|P|(see above). Drowsiness, dizziness, and lightheadedness can||
0905|180|P|increase the risk of falling.||
0905|181|P|   During pregnancy, this medication should be used only when||
0905|182|P|clearly needed. Babies born to mothers who have used this drug||
0905|183|P|during the last 3 months of pregnancy may rarely develop symptoms||
0905|184|P|including muscle stiffness or shakiness, drowsiness,||
0905|185|P|feeding/breathing difficulties, or constant crying. If you notice||
0905|186|P|any of these symptoms in your newborn especially during their||
0905|187|P|first month, tell the doctor right away.||
0905|188|P|   Since untreated mental/mood problems (such as schizophrenia)||
0905|189|P|can be a serious condition, do not stop taking this medication||
0905|190|P|unless directed by your doctor. If you are planning pregnancy,||
0905|191|P|become pregnant, or think you may be pregnant, immediately||
0905|192|P|discuss with your doctor the benefits and risks of using this||
0905|193|P|medication during pregnancy.||
0905|194|P|   This drug passes into breast milk and could have undesirable||
0905|195|P|effects on a nursing infant. Breastfeeding is not recommended||
0905|196|P|while using this drug. Consult your doctor before breastfeeding.||
0905|197|B|||
0905|198|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0905|199|I|medications work or increase your risk for serious side effects.||
0905|200|I|This document does not contain all possible drug interactions.||
0905|201|I|Keep a list of all the products you use (including||
0905|202|I|prescription/nonprescription drugs and herbal products) and share||
0905|203|I|it with your doctor and pharmacist. Do not start, stop, or change||
0905|204|I|the dosage of any medicines without your doctor's approval.||
0905|205|I|   Some products that may interact with this drug include: alpha||
0905|206|I|blockers (such as doxazosin, prazosin, terazosin),||
0905|207|I|metoclopramide, piperazine, certain drugs for high blood pressure||
0905|208|I|(methyldopa, guanethidine, guanadrel, hydralazine).||
0905|209|I|   Many drugs besides zuclopenthixol may affect the heart rhythm||
0905|210|I|(QT prolongation), including amiodarone, dofetilide, pimozide,||
0905|211|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
0905|212|I|erythromycin), among others. Before using zuclopenthixol, report||
0905|213|I|all medications you are currently using to your doctor or||
0905|214|I|pharmacist.||
0905|215|I|   Tell your doctor or pharmacist if you are taking other||
0905|216|I|products that cause drowsiness such as opioid pain or cough||
0905|217|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0905|218|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0905|219|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0905|220|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0905|221|I|diphenhydramine).||
0905|222|I|   Check the labels on all your medicines (such as allergy or||
0905|223|I|cough-and-cold products) because they may contain ingredients||
0905|224|I|that cause drowsiness. Ask your pharmacist about using those||
0905|225|I|products safely.||
0905|226|B|||
0905|227|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0905|228|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0905|229|O|poison control center right away. US residents can call||
0905|230|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0905|231|B|||
0905|232|N|NOTES:  Do not share this medication with others.||
0905|233|N|   Lab and/or medical tests (such as eye exams) may be done while||
0905|234|N|you are taking this medication. Keep all medical and lab||
0905|235|N|appointments. Consult your doctor for more details.||
0905|236|B|||
0905|237|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0905|238|D|remember. If it is near the time of the next dose, skip the||
0905|239|D|missed dose. Take your next dose at the regular time. Do not||
0905|240|D|double the dose to catch up.||
0905|241|B|||
0905|242|R|STORAGE:  Store at room temperature away from light and moisture.||
0905|243|R|Do not store in the bathroom. Keep all medications away from||
0905|244|R|children and pets.||
0905|245|R|   Do not flush medications down the toilet or pour them into a||
0905|246|R|drain unless instructed to do so. Properly discard this product||
0905|247|R|when it is expired or no longer needed. Consult your pharmacist||
0905|248|R|or local waste disposal company.||
0905|249|B|||
0905|250|A|Information last revised October 2025.||
0905|251|A|Copyright(c) 2025 First Databank, Inc.||
0905|252|B|||
0907|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0907|002|Z|does NOT have all possible information about this product. This||
0907|003|Z|information does not assure that this product is safe, effective,||
0907|004|Z|or appropriate for you. This information is not individual||
0907|005|Z|medical advice and does not substitute for the advice of your||
0907|006|Z|health care professional. Always ask your health care||
0907|007|Z|professional for complete information about this product and your||
0907|008|Z|specific health needs.||
0907|009|B|||
0907|010|T|METHOCARBAMOL/IBUPROFEN - ORAL||
0907|011|F|(METH-oh-KAR-ba-mol/EYE-bue-PROE-fen)||
0907|012|B|||
0907|013|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0907|014|W|ibuprofen) may rarely increase the risk for a heart attack or||
0907|015|W|stroke. This effect can happen at any time while taking this drug||
0907|016|W|but is more likely if you take it for a long time. The risk may||
0907|017|W|be greater in older adults or if you have heart disease or||
0907|018|W|increased risk for heart disease (for example, due to smoking,||
0907|019|W|family history of heart disease, or conditions such as high blood||
0907|020|W|pressure or diabetes). Do not take this drug right before or||
0907|021|W|after heart bypass surgery (CABG).||
0907|022|W|   Also, this drug may rarely cause serious (rarely fatal)||
0907|023|W|bleeding from the stomach or intestines. This effect can occur||
0907|024|W|without warning symptoms at any time while taking this drug.||
0907|025|W|Older adults may be at higher risk for this effect.||
0907|026|W|   Stop taking this medication and get medical help right away if||
0907|027|W|you notice any of these rare but serious side effects:||
0907|028|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0907|029|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0907|030|W|shortness of breath, unusual sweating, confusion, weakness on one||
0907|031|W|side of the body, trouble speaking, sudden vision changes.||
0907|032|W|   Talk with your doctor or pharmacist about the risks and||
0907|033|W|benefits of treatment with this medication.||
0907|034|B|||
0907|035|U|USES:  This product is used to treat muscle spasm/pain.||
0907|036|U|Methocarbamol helps to relax the muscles. Ibuprofen is a||
0907|037|U|nonsteroidal anti-inflammatory drug (NSAID) that helps to||
0907|038|U|decrease pain and swelling.||
0907|039|B|||
0907|040|H|HOW TO USE:  Take this medication by mouth with or without food||
0907|041|H|as directed by your doctor. Do not increase your dose or use this||
0907|042|H|drug more often or for longer than prescribed. Your condition||
0907|043|H|will not improve any faster, and your risk of side effects will||
0907|044|H|increase. Take this medication with a full glass of water (8||
0907|045|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
0907|046|H|Do not lie down for at least 10 minutes after taking this||
0907|047|H|medication. If you have stomach upset while taking this||
0907|048|H|medication, take it with food or milk.||
0907|049|H|   The dosage is based on your medical condition and response to||
0907|050|H|treatment. To reduce your risk of stomach bleeding and other side||
0907|051|H|effects, take this medication at the lowest effective dose for||
0907|052|H|the shortest possible time.||
0907|053|H|   If you are taking this drug "as needed" (not on a regular||
0907|054|H|schedule), remember that pain medications work best if they are||
0907|055|H|used as the first signs of pain occur. If you wait until the||
0907|056|H|symptoms have worsened, the medicine may not work as well.||
0907|057|H|   Tell your doctor if your condition gets worse or if it lasts||
0907|058|H|for more than 5 days.||
0907|059|B|||
0907|060|S|SIDE EFFECTS:  See also Warning section.||
0907|061|S|   Upset stomach, nausea, vomiting, heartburn, diarrhea,||
0907|062|S|constipation, headache, dizziness, lightheadedness, or drowsiness||
0907|063|S|may occur. If any of these effects last or get worse, tell your||
0907|064|S|doctor or pharmacist promptly.||
0907|065|S|   Remember that this medication has been prescribed because your||
0907|066|S|doctor has judged that the benefit to you is greater than the||
0907|067|S|risk of side effects. Many people using this medication do not||
0907|068|S|have serious side effects.||
0907|069|S|   This medication may raise your blood pressure. Check your||
0907|070|S|blood pressure regularly and tell your doctor if the results are||
0907|071|S|high.||
0907|072|S|   Tell your doctor right away if you have any serious side||
0907|073|S|effects, including: hearing changes (such as ringing in the||
0907|074|S|ears), difficult/painful swallowing, fast/pounding heartbeat,||
0907|075|S|unexplained stiff neck, signs of kidney problems (such as change||
0907|076|S|in the amount of urine), mental/mood changes (such as confusion,||
0907|077|S|forgetfulness), vision changes (such as blurred vision),||
0907|078|S|frequent/painful urination, easy bruising/bleeding, symptoms of||
0907|079|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
0907|080|S|unusual/sudden weight gain).||
0907|081|S|   This drug may rarely cause serious (possibly fatal) liver||
0907|082|S|disease. Get medical help right away if you have any symptoms of||
0907|083|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0907|084|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
0907|085|S|eyes/skin.||
0907|086|S|   A very serious allergic reaction to this drug is rare.||
0907|087|S|However, get medical help right away if you notice any symptoms||
0907|088|S|of a serious allergic reaction, including: fever, swollen lymph||
0907|089|S|nodes, rash, itching/swelling (especially of the||
0907|090|S|face/tongue/throat), severe dizziness, trouble breathing.||
0907|091|S|   This is not a complete list of possible side effects. If you||
0907|092|S|notice other effects not listed above, contact your doctor or||
0907|093|S|pharmacist.||
0907|094|S|   In the US -||
0907|095|S|   Call your doctor for medical advice about side effects. You||
0907|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0907|097|S|www.fda.gov/medwatch.||
0907|098|S|   In Canada - Call your doctor for medical advice about side||
0907|099|S|effects. You may report side effects to Health Canada at||
0907|100|S|1-866-234-2345.||
0907|101|B|||
0907|102|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0907|103|P|pharmacist if you are allergic to methocarbamol or ibuprofen; or||
0907|104|P|to aspirin or other NSAIDs (such as naproxen, celecoxib); or if||
0907|105|P|you have any other allergies. This product may contain inactive||
0907|106|P|ingredients, which can cause allergic reactions or other||
0907|107|P|problems. Talk to your pharmacist for more details.||
0907|108|P|   Before using this medication, tell your doctor or pharmacist||
0907|109|P|your medical history, especially of: asthma (including a history||
0907|110|P|of worsening breathing after taking aspirin or other NSAIDs),||
0907|111|P|growths in the nose (nasal polyps), stomach/intestine/esophagus||
0907|112|P|problems (such as bleeding, heartburn, ulcers), liver disease,||
0907|113|P|heart disease (such as previous heart attack), blood disorders||
0907|114|P|(such as anemia, bleeding/clotting problems), stroke, high blood||
0907|115|P|pressure.||
0907|116|P|   Kidney problems can sometimes occur with the use of NSAID||
0907|117|P|medications, including ibuprofen. Problems are more likely to||
0907|118|P|occur if you are dehydrated, have heart failure or kidney||
0907|119|P|disease, are an older adult, or if you take certain medications||
0907|120|P|(see also Drug Interactions section). Drink plenty of fluids as||
0907|121|P|directed by your doctor to prevent dehydration and tell your||
0907|122|P|doctor right away if you have a change in the amount of urine.||
0907|123|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0907|124|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0907|125|P|machinery, or do anything that needs alertness until you can do||
0907|126|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0907|127|P|are using marijuana (cannabis).||
0907|128|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0907|129|P|and tobacco, especially when combined with this medicine, may||
0907|130|P|increase your risk for stomach bleeding. Avoid alcohol and stop||
0907|131|P|smoking. Consult your doctor or pharmacist for more information.||
0907|132|P|   Before having surgery, tell your doctor or dentist about all||
0907|133|P|the products you use (including prescription drugs,||
0907|134|P|nonprescription drugs, and herbal products).||
0907|135|P|   This medication may make you more sensitive to the sun. Limit||
0907|136|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0907|137|P|sunscreen and wear protective clothing when outdoors. Tell your||
0907|138|P|doctor right away if you get sunburned or have skin||
0907|139|P|blisters/redness.||
0907|140|P|   Older adults may be at greater risk for stomach/intestinal||
0907|141|P|bleeding, kidney problems, heart attack, stroke, slow/shallow||
0907|142|P|breathing, drowsiness, dizziness, and confusion. Drowsiness,||
0907|143|P|dizziness and confusion can increase the risk of falling.||
0907|144|P|   Before using this medication, women of childbearing age should||
0907|145|P|talk with their doctor(s) about the benefits and risks. Tell your||
0907|146|P|doctor if you are pregnant or if you plan to become pregnant.||
0907|147|P|This medication may harm an unborn baby and cause problems with||
0907|148|P|normal labor/delivery. It is not recommended for use in pregnancy||
0907|149|P|from 20 weeks until delivery. If your doctor decides that you||
0907|150|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0907|151|P|you should use the lowest effective dose for the shortest||
0907|152|P|possible time. You should not use this medication after 30 weeks||
0907|153|P|of pregnancy.||
0907|154|P|   It is unknown if methocarbamol passes into breast milk.||
0907|155|P|Ibuprofen passes into breast milk. Consult your doctor before||
0907|156|P|breastfeeding.||
0907|157|B|||
0907|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0907|159|I|medications work or increase your risk for serious side effects.||
0907|160|I|This document does not contain all possible drug interactions.||
0907|161|I|Keep a list of all the products you use (including||
0907|162|I|prescription/nonprescription drugs and herbal products) and share||
0907|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
0907|164|I|the dosage of any medicines without your doctor's approval.||
0907|165|I|   Some products that may interact with this drug include:||
0907|166|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
0907|167|I|angiotensin II receptor blockers (such as losartan, valsartan),||
0907|168|I|cidofovir, corticosteroids (such as dexamethasone), lithium,||
0907|169|I|methotrexate, "water pills" (diuretics such as furosemide).||
0907|170|I|   This medication may increase the risk of bleeding when taken||
0907|171|I|with other drugs that also may cause bleeding. Examples include||
0907|172|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0907|173|I|dabigatran/enoxaparin/warfarin, among others.||
0907|174|I|   Tell your doctor or pharmacist if you are taking other||
0907|175|I|products that cause drowsiness such as opioid pain or cough||
0907|176|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0907|177|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0907|178|I|lorazepam, zolpidem), other muscle relaxants (such as||
0907|179|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0907|180|I|cetirizine, diphenhydramine).||
0907|181|I|   Check the labels on all your medicines (such as allergy or||
0907|182|I|cough-and-cold products) because they may contain ingredients||
0907|183|I|that cause drowsiness. Ask your pharmacist about using those||
0907|184|I|products safely.||
0907|185|I|   Check all prescription and nonprescription medicine labels||
0907|186|I|carefully since many medications contain pain relievers/fever||
0907|187|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
0907|188|I|or naproxen). These drugs are similar to ibuprofen and may||
0907|189|I|increase your risk of side effects if taken together. However, if||
0907|190|I|your doctor has told you to take low-dose aspirin to prevent||
0907|191|I|heart attack or stroke (usually 81-162 milligrams a day), you||
0907|192|I|should keep taking the aspirin unless your doctor tells you not||
0907|193|I|to. Daily use of ibuprofen may decrease aspirin's ability to||
0907|194|I|prevent heart attack/stroke. Talk to your doctor about using a||
0907|195|I|different medication (such as acetaminophen) to treat pain/fever.||
0907|196|I|If you must take ibuprofen, talk to your doctor about taking||
0907|197|I|immediate-release aspirin (not enteric-coated/EC) while taking||
0907|198|I|ibuprofen. Take ibuprofen at least 8 hours before or at least 2||
0907|199|I|hours after your aspirin dose. Do not increase your daily dose of||
0907|200|I|aspirin or change the way you take aspirin/other medications||
0907|201|I|without your doctor's approval.||
0907|202|I|   This medication may interfere with certain lab tests (such as||
0907|203|I|5-HIAA/VMA urine screening tests), possibly causing false test||
0907|204|I|results. Make sure lab personnel and all your doctors know you||
0907|205|I|use this drug.||
0907|206|B|||
0907|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0907|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0907|209|O|poison control center right away. US residents can call||
0907|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0907|211|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
0907|212|O|severe stomach pain, seizures.||
0907|213|B|||
0907|214|N|NOTES:  Do not share this medication with others.||
0907|215|N|   This medication has been prescribed for your current condition||
0907|216|N|only. Do not use it later for another condition unless your||
0907|217|N|doctor directs you to do so. A different medication may be||
0907|218|N|necessary in that case.||
0907|219|N|   Lab and/or medical tests (such as blood pressure, complete||
0907|220|N|blood count, liver/kidney function) may be done while you are||
0907|221|N|taking this medication. Keep all medical and lab appointments.||
0907|222|N|Consult your doctor for more details.||
0907|223|B|||
0907|224|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
0907|225|D|(not just "as needed") and you miss a dose, take it as soon as||
0907|226|D|you remember. If it is near the time of the next dose, skip the||
0907|227|D|missed dose. Take your next dose at the regular time. Do not||
0907|228|D|double the dose to catch up.||
0907|229|B|||
0907|230|R|STORAGE:  Store at room temperature away from light and moisture.||
0907|231|R|Do not store in the bathroom. Keep all medications away from||
0907|232|R|children and pets.||
0907|233|R|   Do not flush medications down the toilet or pour them into a||
0907|234|R|drain unless instructed to do so. Properly discard this product||
0907|235|R|when it is expired or no longer needed. Consult your pharmacist||
0907|236|R|or local waste disposal company.||
0907|237|B|||
0907|238|A|Information last revised May 2024.||
0907|239|A|Copyright(c) 2025 First Databank, Inc.||
0907|240|B|||
0909|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0909|002|Z|does NOT have all possible information about this product. This||
0909|003|Z|information does not assure that this product is safe, effective,||
0909|004|Z|or appropriate for you. This information is not individual||
0909|005|Z|medical advice and does not substitute for the advice of your||
0909|006|Z|health care professional. Always ask your health care||
0909|007|Z|professional for complete information about this product and your||
0909|008|Z|specific health needs.||
0909|009|B|||
0909|010|T|ZUCLOPENTHIXOL ACETATE - INJECTION||
0909|011|F|(zoo-KLOE-pen-THIX-ol AS-e-tate)||
0909|012|B|||
0909|013|W|WARNING:  This medication may rarely cause a serious, possibly||
0909|014|W|fatal condition called neuroleptic malignant syndrome (NMS). Get||
0909|015|W|medical help right away if you have any of the following||
0909|016|W|symptoms: fever, muscle stiffness/pain/tenderness/weakness,||
0909|017|W|severe tiredness, severe confusion, sweating, fast/irregular||
0909|018|W|heartbeat, dark urine, signs of kidney problems (such as change||
0909|019|W|in the amount of urine).||
0909|020|W|   There may be a slightly increased risk of serious, possibly||
0909|021|W|fatal side effects (such as heart failure, fast/irregular||
0909|022|W|heartbeat, pneumonia) when this medication is used by older||
0909|023|W|adults with dementia. This medication is not approved for the||
0909|024|W|treatment of dementia-related behavior problems. Discuss the||
0909|025|W|risks and benefits of this medication, as well as other effective||
0909|026|W|and possibly safer treatments for dementia-related behavior||
0909|027|W|problems, with the doctor.||
0909|028|B|||
0909|029|U|USES:  This medication is used to treat severe symptoms of||
0909|030|U|certain mental/mood disorders (such as schizophrenia). It is||
0909|031|U|given by injection when quick relief of your symptoms is required||
0909|032|U|and you are unable to take the medication by mouth.||
0909|033|U|Zuclopenthixol belongs to a class of drugs known as||
0909|034|U|antipsychotics. It works by helping to restore the balance of||
0909|035|U|certain natural substances in the brain.||
0909|036|B|||
0909|037|H|HOW TO USE:  This medication is given by injection into a muscle||
0909|038|H|by a health care professional. Your dose may be repeated in 1 to||
0909|039|H|2 days after the first injection and then the medication is given||
0909|040|H|as directed by your doctor, usually every 2 to 3 days as needed.||
0909|041|H|The dosage is based on your condition and response to treatment.||
0909|042|H|   This medication should not be used for longer than 2 weeks or||
0909|043|H|more than 4 injections. After you are feeling better, your doctor||
0909|044|H|may switch you to medication taken by mouth or a longer-acting||
0909|045|H|injection.||
0909|046|H|   Do not stop using this medication without consulting your||
0909|047|H|doctor. Some conditions may become worse when the drug is||
0909|048|H|suddenly stopped. Your dose may need to be gradually reduced.||
0909|049|H|   This medication does not work right away. It may take 2 to 4||
0909|050|H|hours before you see an effect. Tell your doctor if your symptoms||
0909|051|H|do not get better or if they get worse.||
0909|052|B|||
0909|053|S|SIDE EFFECTS:  See also Warning section.||
0909|054|S|   Dizziness, lightheadedness, drowsiness, constipation,||
0909|055|S|headache, dry mouth, blurred vision, difficulty urinating,||
0909|056|S|tiredness, or pain/redness at the injection site may occur. If||
0909|057|S|these effects last or get worse, tell your doctor or pharmacist||
0909|058|S|promptly.||
0909|059|S|   Dizziness and lightheadedness can increase the risk of||
0909|060|S|falling. Get up slowly when rising from a sitting or lying||
0909|061|S|position.||
0909|062|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0909|063|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0909|064|S|substitute.||
0909|065|S|   Tell your doctor right away if any of these side effects||
0909|066|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
0909|067|S|mask-like expression of the face, drooling/trouble swallowing, or||
0909|068|S|shuffling walk. Your doctor may prescribe another medication to||
0909|069|S|decrease these side effects.||
0909|070|S|   Remember that this medication has been prescribed because your||
0909|071|S|doctor has judged that the benefit to you is greater than the||
0909|072|S|risk of side effects. Many people using this medication do not||
0909|073|S|have serious side effects.||
0909|074|S|   In rare cases, zuclopenthixol may increase your level of a||
0909|075|S|certain substance made by the body (prolactin). For females, this||
0909|076|S|increase in prolactin may result in unwanted breast milk,||
0909|077|S|missed/stopped periods, or difficulty becoming pregnant. For||
0909|078|S|males, it may result in decreased sexual ability, inability to||
0909|079|S|produce sperm, or enlarged breasts. If you develop any of these||
0909|080|S|symptoms, tell your doctor right away.||
0909|081|S|   Rarely, males may have a painful or prolonged erection lasting||
0909|082|S|4 or more hours. If this occurs, stop using this drug and get||
0909|083|S|medical help right away, or permanent problems could occur.||
0909|084|S|   This medication may rarely cause a condition known as tardive||
0909|085|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0909|086|S|your doctor right away if you develop any uncontrollable||
0909|087|S|facial/muscle twitching or movements such as tongue thrusting,||
0909|088|S|chewing movements, unusual movements of the mouth/lips, or||
0909|089|S|shaking.||
0909|090|S|   Tell your doctor right away if you have any serious side||
0909|091|S|effects, including: nausea/vomiting that doesn't stop,||
0909|092|S|stomach/abdominal pain, yellowing eyes/skin.||
0909|093|S|   Get medical help right away if you have any very serious side||
0909|094|S|effects, including: slow heartbeat, chest pain, severe dizziness,||
0909|095|S|fainting, seizures.||
0909|096|S|   A very serious allergic reaction to this product is rare.||
0909|097|S|However, get medical help right away if you notice any symptoms||
0909|098|S|of a serious allergic reaction, including: rash, itching/swelling||
0909|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0909|100|S|breathing.||
0909|101|S|   This is not a complete list of possible side effects. If you||
0909|102|S|notice other effects not listed above, contact your doctor or||
0909|103|S|pharmacist.||
0909|104|S|   In the US -||
0909|105|S|   Call your doctor for medical advice about side effects. You||
0909|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0909|107|S|www.fda.gov/medwatch.||
0909|108|S|   In Canada - Call your doctor for medical advice about side||
0909|109|S|effects. You may report side effects to Health Canada at||
0909|110|S|1-866-234-2345.||
0909|111|B|||
0909|112|P|PRECAUTIONS:  Before using zuclopenthixol, tell your doctor or||
0909|113|P|pharmacist if you are allergic to it; or if you have any other||
0909|114|P|allergies. This product may contain inactive ingredients, which||
0909|115|P|can cause allergic reactions or other problems. Talk to your||
0909|116|P|pharmacist for more details.||
0909|117|P|   Before using this medication, tell your doctor or pharmacist||
0909|118|P|your medical history, especially of: blood problems (such as low||
0909|119|P|number of red cells, white cells, or platelets), brain||
0909|120|P|injury/tumor, narrow-angle glaucoma, a certain adrenal gland||
0909|121|P|tumor (pheochromocytoma), breast cancer, breathing problems (such||
0909|122|P|as asthma, bronchitis), slowed gut movement (such as chronic||
0909|123|P|constipation, ileus, blockage), heart problems (such as angina,||
0909|124|P|irregular heartbeat), kidney disease, liver disease, certain||
0909|125|P|muscle problem (myasthenia gravis), neuroleptic malignant||
0909|126|P|syndrome, Parkinson's disease, pituitary tumor, regular/heavy use||
0909|127|P|of alcohol/sedatives, overactive thyroid (hyperthyroidism),||
0909|128|P|seizures, difficulty urinating (such as due to prostate||
0909|129|P|problems).||
0909|130|P|   Zuclopenthixol may cause a condition that affects the heart||
0909|131|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0909|132|P|serious (rarely fatal) fast/irregular heartbeat and other||
0909|133|P|symptoms (such as severe dizziness, fainting) that need medical||
0909|134|P|attention right away.||
0909|135|P|   The risk of QT prolongation may be increased if you have||
0909|136|P|certain medical conditions or are taking other drugs that may||
0909|137|P|cause QT prolongation. Before using zuclopenthixol, tell your||
0909|138|P|doctor or pharmacist of all the drugs you take and if you have||
0909|139|P|any of the following conditions: certain heart problems (heart||
0909|140|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0909|141|P|history of certain heart problems (QT prolongation in the EKG,||
0909|142|P|sudden cardiac death).||
0909|143|P|   Low levels of potassium or magnesium in the blood may also||
0909|144|P|increase your risk of QT prolongation. This risk may increase if||
0909|145|P|you use certain drugs (such as diuretics/"water pills") or if you||
0909|146|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0909|147|P|Talk to your doctor about using zuclopenthixol safely.||
0909|148|P|   This drug may make you dizzy or drowsy or blur your vision.||
0909|149|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0909|150|P|drowsy. Do not drive, use machinery, or do anything that needs||
0909|151|P|alertness or clear vision until you can do it safely. Limit||
0909|152|P|alcoholic beverages. Talk to your doctor if you are using||
0909|153|P|marijuana (cannabis).||
0909|154|P|   Before having procedures with injected dye (such as certain||
0909|155|P|X-ray procedures) or surgery, tell your doctor, radiologist, or||
0909|156|P|dentist that you are using zuclopenthixol.||
0909|157|P|   This medication may make you sweat less, making you more||
0909|158|P|likely to get heat stroke. Avoid doing things that may cause you||
0909|159|P|to overheat, such as hard work or exercise in hot weather, or||
0909|160|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0909|161|P|and dress lightly. If you overheat, quickly look for a place to||
0909|162|P|cool down and rest. Get medical help right away if you have a||
0909|163|P|fever that does not go away, mental/mood changes, headache, or||
0909|164|P|dizziness.||
0909|165|P|   This medication may make you more sensitive to the sun. Limit||
0909|166|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0909|167|P|sunscreen and wear protective clothing when outdoors. Tell your||
0909|168|P|doctor right away if you get sunburned or have skin||
0909|169|P|blisters/redness.||
0909|170|P|   Older adults may be more sensitive to the side effects of this||
0909|171|P|drug, especially drowsiness, dizziness, lightheadedness,||
0909|172|P|difficulty urinating, and heart effects such as QT prolongation||
0909|173|P|(see above). Drowsiness, dizziness, and lightheadedness can||
0909|174|P|increase the risk of falling.||
0909|175|P|   During pregnancy, this medication should be used only when||
0909|176|P|clearly needed. Babies born to mothers who have used this drug||
0909|177|P|during the last 3 months of pregnancy may rarely develop symptoms||
0909|178|P|including muscle stiffness or shakiness, drowsiness,||
0909|179|P|feeding/breathing difficulties, or constant crying. If you notice||
0909|180|P|any of these symptoms in your newborn especially during their||
0909|181|P|first month, tell the doctor right away.||
0909|182|P|   Since untreated mental/mood problems (such as schizophrenia)||
0909|183|P|can be a serious condition, do not stop taking this medication||
0909|184|P|unless directed by your doctor. If you are planning pregnancy,||
0909|185|P|become pregnant, or think you may be pregnant, immediately||
0909|186|P|discuss with your doctor the benefits and risks of using this||
0909|187|P|medication during pregnancy.||
0909|188|P|   This drug passes into breast milk and could have undesirable||
0909|189|P|effects on a nursing infant. Breastfeeding is not recommended||
0909|190|P|while using this drug. Consult your doctor before breastfeeding.||
0909|191|B|||
0909|192|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0909|193|I|medications work or increase your risk for serious side effects.||
0909|194|I|This document does not contain all possible drug interactions.||
0909|195|I|Keep a list of all the products you use (including||
0909|196|I|prescription/nonprescription drugs and herbal products) and share||
0909|197|I|it with your doctor and pharmacist. Do not start, stop, or change||
0909|198|I|the dosage of any medicines without your doctor's approval.||
0909|199|I|   Some products that may interact with this drug include: alpha||
0909|200|I|blockers (such as doxazosin, prazosin, terazosin),||
0909|201|I|metoclopramide, piperazine, certain drugs for high blood pressure||
0909|202|I|(methyldopa, guanethidine, guanadrel, hydralazine).||
0909|203|I|   Many drugs besides zuclopenthixol may affect the heart rhythm||
0909|204|I|(QT prolongation), including amiodarone, dofetilide, pimozide,||
0909|205|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
0909|206|I|erythromycin), among others. Before using zuclopenthixol, report||
0909|207|I|all medications you are currently using to your doctor or||
0909|208|I|pharmacist.||
0909|209|I|   Tell your doctor or pharmacist if you are taking other||
0909|210|I|products that cause drowsiness such as opioid pain or cough||
0909|211|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0909|212|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0909|213|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0909|214|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0909|215|I|diphenhydramine).||
0909|216|I|   Check the labels on all your medicines (such as allergy or||
0909|217|I|cough-and-cold products) because they may contain ingredients||
0909|218|I|that cause drowsiness. Ask your pharmacist about using those||
0909|219|I|products safely.||
0909|220|B|||
0909|221|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0909|222|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0909|223|O|poison control center right away. US residents can call||
0909|224|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0909|225|B|||
0909|226|N|NOTES:  Lab and/or medical tests (such as eye exams) may be done||
0909|227|N|while you are using this medication. Keep all medical and lab||
0909|228|N|appointments. Consult your doctor for more details.||
0909|229|B|||
0909|230|D|MISSED DOSE:  It is important to get each dose of this medication||
0909|231|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0909|232|D|right away for a new dosing schedule.||
0909|233|B|||
0909|234|R|STORAGE:  Not applicable. This medication is given in a hospital||
0909|235|R|and will not be stored at home.||
0909|236|B|||
0909|237|A|Information last revised October 2025.||
0909|238|A|Copyright(c) 2025 First Databank, Inc.||
0909|239|B|||
0910|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0910|002|Z|does NOT have all possible information about this product. This||
0910|003|Z|information does not assure that this product is safe, effective,||
0910|004|Z|or appropriate for you. This information is not individual||
0910|005|Z|medical advice and does not substitute for the advice of your||
0910|006|Z|health care professional. Always ask your health care||
0910|007|Z|professional for complete information about this product and your||
0910|008|Z|specific health needs.||
0910|009|B|||
0910|010|T|ZUCLOPENTHIXOL DECANOATE - INJECTION||
0910|011|F|(zoo-kloh-pen-THICKS-ohl)||
0910|012|B|||
0910|013|W|WARNING:  This medication may rarely cause a serious, possibly||
0910|014|W|fatal condition called neuroleptic malignant syndrome (NMS). Get||
0910|015|W|medical help right away if you have any of the following||
0910|016|W|symptoms: fever, muscle stiffness/pain/tenderness/weakness,||
0910|017|W|severe tiredness, severe confusion, sweating, fast/irregular||
0910|018|W|heartbeat, dark urine, signs of kidney problems (such as change||
0910|019|W|in the amount of urine).||
0910|020|W|   There may be a slightly increased risk of serious, possibly||
0910|021|W|fatal side effects (such as heart failure, fast/irregular||
0910|022|W|heartbeat, pneumonia) when this medication is used by older||
0910|023|W|adults with dementia. This medication is not approved for the||
0910|024|W|treatment of dementia-related behavior problems. Discuss the||
0910|025|W|risks and benefits of this medication, as well as other effective||
0910|026|W|and possibly safer treatments for dementia-related behavior||
0910|027|W|problems, with the doctor.||
0910|028|B|||
0910|029|U|USES:  This medication is used to treat a certain mental/mood||
0910|030|U|disorder (schizophrenia). Zuclopenthixol decanoate is a||
0910|031|U|long-acting form of zuclopenthixol. It may be used by people who||
0910|032|U|have trouble remembering to take medication every day.||
0910|033|U|Zuclopenthixol belongs to a class of drugs known as||
0910|034|U|antipsychotics. It works by helping to restore the balance of||
0910|035|U|certain natural substances in the brain.||
0910|036|B|||
0910|037|H|HOW TO USE:  This medication is given by injection into a muscle||
0910|038|H|by a health care professional. This medication is injected as||
0910|039|H|directed by your doctor, usually every 2 to 4 weeks. The dosage||
0910|040|H|is based on your medical condition and response to treatment.||
0910|041|H|   Use this medication regularly to get the most benefit from it.||
0910|042|H|To help you remember, mark your calendar with a reminder.||
0910|043|H|   This product does not work right away. It may take 1 to 2||
0910|044|H|weeks to notice an effect from this drug and up to 4 weeks to||
0910|045|H|experience the full effect. For severe agitation or other||
0910|046|H|symptoms, use a short-acting medication as directed by your||
0910|047|H|doctor. Your doctor may direct you to take a medication by mouth||
0910|048|H|or use a different injection until this medication starts to||
0910|049|H|work.||
0910|050|H|   Do not stop using this medication without consulting your||
0910|051|H|doctor. Some conditions may become worse when the drug is||
0910|052|H|suddenly stopped. Your dose may need to be gradually reduced.||
0910|053|H|   Tell your doctor if your symptoms do not get better or if they||
0910|054|H|get worse.||
0910|055|B|||
0910|056|S|SIDE EFFECTS:  See also Warning section.||
0910|057|S|   Dizziness, lightheadedness, drowsiness, constipation,||
0910|058|S|headache, dry mouth, blurred vision, difficulty urinating,||
0910|059|S|tiredness, or pain/redness at the injection site may occur. If||
0910|060|S|these effects last or get worse, tell your doctor or pharmacist||
0910|061|S|promptly.||
0910|062|S|   Dizziness and lightheadedness can increase the risk of||
0910|063|S|falling. Get up slowly when rising from a sitting or lying||
0910|064|S|position.||
0910|065|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
0910|066|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0910|067|S|substitute.||
0910|068|S|   Tell your doctor right away if any of these side effects||
0910|069|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
0910|070|S|mask-like expression of the face, drooling/trouble swallowing, or||
0910|071|S|shuffling walk. Your doctor may prescribe another medication to||
0910|072|S|decrease these side effects.||
0910|073|S|   Remember that this medication has been prescribed because your||
0910|074|S|doctor has judged that the benefit to you is greater than the||
0910|075|S|risk of side effects. Many people using this medication do not||
0910|076|S|have serious side effects.||
0910|077|S|   In rare cases, zuclopenthixol may increase your level of a||
0910|078|S|certain substance made by the body (prolactin). For females, this||
0910|079|S|increase in prolactin may result in unwanted breast milk,||
0910|080|S|missed/stopped periods, or difficulty becoming pregnant. For||
0910|081|S|males, it may result in decreased sexual ability, inability to||
0910|082|S|produce sperm, or enlarged breasts. If you develop any of these||
0910|083|S|symptoms, tell your doctor right away.||
0910|084|S|   Rarely, males may have a painful or prolonged erection lasting||
0910|085|S|4 or more hours. If this occurs, stop using this drug and get||
0910|086|S|medical help right away, or permanent problems could occur.||
0910|087|S|   This medication may rarely cause a condition known as tardive||
0910|088|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0910|089|S|your doctor right away if you develop any uncontrollable||
0910|090|S|facial/muscle twitching or movements such as tongue thrusting,||
0910|091|S|chewing movements, unusual movements of the mouth/lips, or||
0910|092|S|shaking.||
0910|093|S|   Tell your doctor right away if you have any serious side||
0910|094|S|effects, including: nausea/vomiting that doesn't stop,||
0910|095|S|stomach/abdominal pain, yellowing eyes/skin.||
0910|096|S|   Get medical help right away if you have any very serious side||
0910|097|S|effects, including: slow heartbeat, chest pain, severe dizziness,||
0910|098|S|fainting, seizures.||
0910|099|S|   A very serious allergic reaction to this product is rare.||
0910|100|S|However, get medical help right away if you notice any symptoms||
0910|101|S|of a serious allergic reaction, including: rash, itching/swelling||
0910|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0910|103|S|breathing.||
0910|104|S|   This is not a complete list of possible side effects. If you||
0910|105|S|notice other effects not listed above, contact your doctor or||
0910|106|S|pharmacist.||
0910|107|S|   In the US -||
0910|108|S|   Call your doctor for medical advice about side effects. You||
0910|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0910|110|S|www.fda.gov/medwatch.||
0910|111|S|   In Canada - Call your doctor for medical advice about side||
0910|112|S|effects. You may report side effects to Health Canada at||
0910|113|S|1-866-234-2345.||
0910|114|B|||
0910|115|P|PRECAUTIONS:  Before using zuclopenthixol, tell your doctor or||
0910|116|P|pharmacist if you are allergic to it; or if you have any other||
0910|117|P|allergies. This product may contain inactive ingredients, which||
0910|118|P|can cause allergic reactions or other problems. Talk to your||
0910|119|P|pharmacist for more details.||
0910|120|P|   Before using this medication, tell your doctor or pharmacist||
0910|121|P|your medical history, especially of: blood problems (such as low||
0910|122|P|number of red cells, white cells, or platelets), brain||
0910|123|P|injury/tumor, narrow-angle glaucoma, a certain adrenal gland||
0910|124|P|tumor (pheochromocytoma), breast cancer, breathing problems (such||
0910|125|P|as asthma, bronchitis), slowed gut movement (such as chronic||
0910|126|P|constipation, ileus, blockage), heart problems (such as angina,||
0910|127|P|irregular heartbeat), kidney disease, liver disease, certain||
0910|128|P|muscle problem (myasthenia gravis), neuroleptic malignant||
0910|129|P|syndrome, Parkinson's disease, pituitary tumor, regular/heavy use||
0910|130|P|of alcohol/sedatives, overactive thyroid (hyperthyroidism),||
0910|131|P|seizures, difficulty urinating (such as due to prostate||
0910|132|P|problems).||
0910|133|P|   Zuclopenthixol may cause a condition that affects the heart||
0910|134|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0910|135|P|serious (rarely fatal) fast/irregular heartbeat and other||
0910|136|P|symptoms (such as severe dizziness, fainting) that need medical||
0910|137|P|attention right away.||
0910|138|P|   The risk of QT prolongation may be increased if you have||
0910|139|P|certain medical conditions or are taking other drugs that may||
0910|140|P|cause QT prolongation. Before using zuclopenthixol, tell your||
0910|141|P|doctor or pharmacist of all the drugs you take and if you have||
0910|142|P|any of the following conditions: certain heart problems (heart||
0910|143|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0910|144|P|history of certain heart problems (QT prolongation in the EKG,||
0910|145|P|sudden cardiac death).||
0910|146|P|   Low levels of potassium or magnesium in the blood may also||
0910|147|P|increase your risk of QT prolongation. This risk may increase if||
0910|148|P|you use certain drugs (such as diuretics/"water pills") or if you||
0910|149|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0910|150|P|Talk to your doctor about using zuclopenthixol safely.||
0910|151|P|   This drug may make you dizzy or drowsy or blur your vision.||
0910|152|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0910|153|P|drowsy. Do not drive, use machinery, or do anything that needs||
0910|154|P|alertness or clear vision until you can do it safely. Limit||
0910|155|P|alcoholic beverages. Talk to your doctor if you are using||
0910|156|P|marijuana (cannabis).||
0910|157|P|   Before having procedures with injected dye (such as certain||
0910|158|P|X-ray procedures) or surgery, tell your doctor, radiologist, or||
0910|159|P|dentist that you are using zuclopenthixol.||
0910|160|P|   This medication may make you sweat less, making you more||
0910|161|P|likely to get heat stroke. Avoid doing things that may cause you||
0910|162|P|to overheat, such as hard work or exercise in hot weather, or||
0910|163|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0910|164|P|and dress lightly. If you overheat, quickly look for a place to||
0910|165|P|cool down and rest. Get medical help right away if you have a||
0910|166|P|fever that does not go away, mental/mood changes, headache, or||
0910|167|P|dizziness.||
0910|168|P|   This medication may make you more sensitive to the sun. Limit||
0910|169|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0910|170|P|sunscreen and wear protective clothing when outdoors. Tell your||
0910|171|P|doctor right away if you get sunburned or have skin||
0910|172|P|blisters/redness.||
0910|173|P|   Older adults may be more sensitive to the side effects of this||
0910|174|P|drug, especially drowsiness, dizziness, lightheadedness,||
0910|175|P|difficulty urinating, and heart effects such as QT prolongation||
0910|176|P|(see above). Drowsiness, dizziness, and lightheadedness can||
0910|177|P|increase the risk of falling.||
0910|178|P|   During pregnancy, this medication should be used only when||
0910|179|P|clearly needed. Babies born to mothers who have used this drug||
0910|180|P|during the last 3 months of pregnancy may rarely develop symptoms||
0910|181|P|including muscle stiffness or shakiness, drowsiness,||
0910|182|P|feeding/breathing difficulties, or constant crying. If you notice||
0910|183|P|any of these symptoms in your newborn especially during their||
0910|184|P|first month, tell the doctor right away.||
0910|185|P|   Since untreated mental/mood problems (such as schizophrenia)||
0910|186|P|can be a serious condition, do not stop taking this medication||
0910|187|P|unless directed by your doctor. If you are planning pregnancy,||
0910|188|P|become pregnant, or think you may be pregnant, immediately||
0910|189|P|discuss with your doctor the benefits and risks of using this||
0910|190|P|medication during pregnancy.||
0910|191|P|   This drug passes into breast milk and could have undesirable||
0910|192|P|effects on a nursing infant. Breastfeeding is not recommended||
0910|193|P|while using this drug. Consult your doctor before breastfeeding.||
0910|194|B|||
0910|195|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0910|196|I|medications work or increase your risk for serious side effects.||
0910|197|I|This document does not contain all possible drug interactions.||
0910|198|I|Keep a list of all the products you use (including||
0910|199|I|prescription/nonprescription drugs and herbal products) and share||
0910|200|I|it with your doctor and pharmacist. Do not start, stop, or change||
0910|201|I|the dosage of any medicines without your doctor's approval.||
0910|202|I|   Some products that may interact with this drug include: alpha||
0910|203|I|blockers (such as doxazosin, prazosin, terazosin),||
0910|204|I|metoclopramide, piperazine, certain drugs for high blood pressure||
0910|205|I|(methyldopa, guanethidine, guanadrel, hydralazine).||
0910|206|I|   Many drugs besides zuclopenthixol may affect the heart rhythm||
0910|207|I|(QT prolongation), including amiodarone, dofetilide, pimozide,||
0910|208|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
0910|209|I|erythromycin), among others. Before using zuclopenthixol, report||
0910|210|I|all medications you are currently using to your doctor or||
0910|211|I|pharmacist.||
0910|212|I|   Tell your doctor or pharmacist if you are taking other||
0910|213|I|products that cause drowsiness such as opioid pain or cough||
0910|214|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0910|215|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0910|216|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0910|217|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0910|218|I|diphenhydramine).||
0910|219|I|   Check the labels on all your medicines (such as allergy or||
0910|220|I|cough-and-cold products) because they may contain ingredients||
0910|221|I|that cause drowsiness. Ask your pharmacist about using those||
0910|222|I|products safely.||
0910|223|B|||
0910|224|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0910|225|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0910|226|O|poison control center right away. US residents can call||
0910|227|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0910|228|B|||
0910|229|N|NOTES:  Lab and/or medical tests (such as eye exams) may be done||
0910|230|N|while you are using this medication. Keep all medical and lab||
0910|231|N|appointments. Consult your doctor for more details.||
0910|232|B|||
0910|233|D|MISSED DOSE:  It is important to get each dose of this medication||
0910|234|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0910|235|D|right away for a new dosing schedule.||
0910|236|B|||
0910|237|R|STORAGE:  Not applicable. This medication is given in a hospital||
0910|238|R|and will not be stored at home.||
0910|239|B|||
0910|240|A|Information last revised October 2025.||
0910|241|A|Copyright(c) 2025 First Databank, Inc.||
0910|242|B|||
0911|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0911|002|Z|does NOT have all possible information about this product. This||
0911|003|Z|information does not assure that this product is safe, effective,||
0911|004|Z|or appropriate for you. This information is not individual||
0911|005|Z|medical advice and does not substitute for the advice of your||
0911|006|Z|health care professional. Always ask your health care||
0911|007|Z|professional for complete information about this product and your||
0911|008|Z|specific health needs.||
0911|009|B|||
0911|010|T|BECLOMETHASONE DIPROPIONATE - TOPICAL||
0911|011|F|(BE-kloe-METH-a-sone dye-PROE-pee-oh-nate)||
0911|012|B|||
0911|013|U|USES:  This medication is used to treat a variety of skin||
0911|014|U|conditions (such as psoriasis, eczema, dermatitis, allergies,||
0911|015|U|rash). Beclomethasone reduces the swelling, itching, and redness||
0911|016|U|that can occur in these types of conditions. It can also help to||
0911|017|U|heal the rough, scaly skin patches seen with psoriasis.||
0911|018|U|Beclomethasone is a strong (high-potency) corticosteroid.||
0911|019|B|||
0911|020|H|HOW TO USE:  Use this medication on the skin only. Do not use it||
0911|021|H|on the face, groin, or underarms unless directed to do so by your||
0911|022|H|doctor.||
0911|023|H|   Wash and dry your hands before using. Clean and dry the||
0911|024|H|affected area. Apply a small amount of medication to the affected||
0911|025|H|area and gently rub in as directed by your doctor, usually 2||
0911|026|H|times daily. Do not bandage, cover, or wrap the area unless||
0911|027|H|directed to do so by your doctor.||
0911|028|H|   After applying the medication, wash your hands unless you are||
0911|029|H|using this medication to treat the hands. When applying this||
0911|030|H|medication near the eyes, avoid getting it in the eyes because||
0911|031|H|doing so may worsen or cause glaucoma. Also, avoid getting this||
0911|032|H|medication in the nose or mouth. If you get the medication in||
0911|033|H|these areas, rinse with plenty of water. If irritation occurs,||
0911|034|H|contact your doctor right away.||
0911|035|H|   Tell your doctor if your condition lasts or gets worse after 2||
0911|036|H|to 4 weeks.||
0911|037|B|||
0911|038|S|SIDE EFFECTS:  Burning, itching, irritation, or dryness may occur||
0911|039|S|when this medication is first applied to the skin. Acne, unusual||
0911|040|S|hair growth, or small red bumps on the skin (folliculitis) may||
0911|041|S|also occur. If any of these effects last or get worse, tell your||
0911|042|S|doctor or pharmacist promptly.||
0911|043|S|   Remember that this medication has been prescribed because your||
0911|044|S|doctor has judged that the benefit to you is greater than the||
0911|045|S|risk of side effects. Many people using this medication do not||
0911|046|S|have serious side effects.||
0911|047|S|   Tell your doctor right away if you have any serious side||
0911|048|S|effects, including: stretch marks, skin thinning/discoloration.||
0911|049|S|   Skin infections can become worse when this medication is used.||
0911|050|S|Tell your doctor promptly if redness, swelling, or irritation||
0911|051|S|does not improve.||
0911|052|S|   Rarely, it is possible this medication will be absorbed from||
0911|053|S|the skin into the bloodstream. This can lead to side effects of||
0911|054|S|too much corticosteroid. These side effects are more likely in||
0911|055|S|children, and in people who use this medication for a long time||
0911|056|S|or over large areas of the skin. Tell your doctor right away if||
0911|057|S|any of the following side effects occur: unusual/extreme||
0911|058|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
0911|059|S|thirst/urination, vision problems.||
0911|060|S|   A very serious allergic reaction to this drug is rare.||
0911|061|S|However, get medical help right away if you notice any symptoms||
0911|062|S|of a serious allergic reaction, including: rash, itching/swelling||
0911|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0911|064|S|breathing.||
0911|065|S|   This is not a complete list of possible side effects. If you||
0911|066|S|notice other effects not listed above, contact your doctor or||
0911|067|S|pharmacist.||
0911|068|S|   In the US -||
0911|069|S|   Call your doctor for medical advice about side effects. You||
0911|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0911|071|S|www.fda.gov/medwatch.||
0911|072|S|   In Canada - Call your doctor for medical advice about side||
0911|073|S|effects. You may report side effects to Health Canada at||
0911|074|S|1-866-234-2345.||
0911|075|B|||
0911|076|P|PRECAUTIONS:  Before using beclomethasone, tell your doctor or||
0911|077|P|pharmacist if you are allergic to it; or to other corticosteroids||
0911|078|P|(such as hydrocortisone, prednisone); or if you have any other||
0911|079|P|allergies. This product may contain inactive ingredients, which||
0911|080|P|can cause allergic reactions or other problems. Talk to your||
0911|081|P|pharmacist for more details.||
0911|082|P|   Before using this medication, tell your doctor or pharmacist||
0911|083|P|your medical history, especially of: certain skin conditions||
0911|084|P|(rosacea, perioral dermatitis).||
0911|085|P|   Do not use this medication if there is an infection or sore||
0911|086|P|present in the area to be treated. Skin infections can become||
0911|087|P|worse when this medication is used. Tell your doctor promptly if||
0911|088|P|you experience signs of a skin infection such as increasing||
0911|089|P|redness, pus, swelling, or pain.||
0911|090|P|   Rarely, using corticosteroid medications for a long time or||
0911|091|P|over large areas of skin can make it more difficult for your body||
0911|092|P|to respond to physical stress. Before having surgery or emergency||
0911|093|P|treatment, or if you get a serious illness/injury, tell your||
0911|094|P|doctor or dentist that you are using this medication or have used||
0911|095|P|this medication within the past few months.||
0911|096|P|   Though it is unlikely, this medication may temporarily slow||
0911|097|P|down a child's growth if used for a long time. See the doctor||
0911|098|P|regularly so your child's height can be checked.||
0911|099|P|   During pregnancy, this medication should be used only when||
0911|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
0911|101|P|   It is unknown if this drug passes into breast milk when||
0911|102|P|applied to the skin. Similar medications pass into breast milk||
0911|103|P|when taken by mouth. Consult your doctor before breastfeeding.||
0911|104|B|||
0911|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0911|106|I|medications work or increase your risk for serious side effects.||
0911|107|I|This document does not contain all possible drug interactions.||
0911|108|I|Keep a list of all the products you use (including||
0911|109|I|prescription/nonprescription drugs and herbal products) and share||
0911|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0911|111|I|the dosage of any medicines without your doctor's approval.||
0911|112|B|||
0911|113|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0911|114|O|has overdosed and has serious symptoms such as passing out or||
0911|115|O|trouble breathing, call 911. Otherwise, call a poison control||
0911|116|O|center right away. US residents can call 1-800-222-1222. Canada||
0911|117|O|residents can call 1-844-764-7669.||
0911|118|B|||
0911|119|N|NOTES:  Do not share this medication with others.||
0911|120|N|   This medication has been prescribed for your current condition||
0911|121|N|only. Do not use it later for other skin problems unless told to||
0911|122|N|do so by your doctor. A different medication may be necessary in||
0911|123|N|those cases.||
0911|124|N|   Lab and/or medical tests (such as adrenal gland function) may||
0911|125|N|be done while you are using this medication, especially if you||
0911|126|N|use this drug for an extended period of time or apply it over||
0911|127|N|large areas of the body. Keep all medical and lab appointments.||
0911|128|N|Consult your doctor for more details.||
0911|129|B|||
0911|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0911|131|D|If it is near the time of the next dose, skip the missed dose.||
0911|132|D|Use your next dose at the regular time. Do not double the dose to||
0911|133|D|catch up.||
0911|134|B|||
0911|135|R|STORAGE:  Store at room temperature. Keep all medications away||
0911|136|R|from children and pets.||
0911|137|R|   Do not flush medications down the toilet or pour them into a||
0911|138|R|drain unless instructed to do so. Properly discard this product||
0911|139|R|when it is expired or no longer needed. Consult your pharmacist||
0911|140|R|or local waste disposal company.||
0911|141|B|||
0911|142|A|Information last revised May 2024.||
0911|143|A|Copyright(c) 2025 First Databank, Inc.||
0911|144|B|||
0912|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0912|002|Z|does NOT have all possible information about this product. This||
0912|003|Z|information does not assure that this product is safe, effective,||
0912|004|Z|or appropriate for you. This information is not individual||
0912|005|Z|medical advice and does not substitute for the advice of your||
0912|006|Z|health care professional. Always ask your health care||
0912|007|Z|professional for complete information about this product and your||
0912|008|Z|specific health needs.||
0912|009|B|||
0912|010|T|METHOCARBAMOL/ACETAMINOPHEN/CODEINE - ORAL||
0912|011|F|(METH-oh-KAR-ba-mol/a-SEET-a-MIN-oh-fen/KOE-deen)||
0912|012|B|||
0912|013|W|WARNING:  Codeine has a risk for abuse and addiction, which can||
0912|014|W|lead to overdose and death. Codeine may also cause severe,||
0912|015|W|possibly fatal, breathing problems. To lower your risk, your||
0912|016|W|doctor should have you take the smallest dose of codeine that||
0912|017|W|works, and take it for the shortest possible time. See also How||
0912|018|W|to Use section for more information about addiction.||
0912|019|W|   Ask your doctor or pharmacist if you should have medication||
0912|020|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0912|021|W|Teach your family or household members about the signs of an||
0912|022|W|opioid overdose and how to treat it.||
0912|023|W|   The risk for severe breathing problems is higher when you||
0912|024|W|start this medication and after a dose increase, or if you take||
0912|025|W|the wrong dose/strength. Taking this medication with alcohol or||
0912|026|W|other drugs that can cause drowsiness or breathing problems may||
0912|027|W|cause very serious side effects, including death. Also, other||
0912|028|W|medications can affect the removal of codeine from your body,||
0912|029|W|which may affect how codeine works. Be sure you know how to take||
0912|030|W|this medication and what other drugs you should avoid taking with||
0912|031|W|it. See also Drug Interactions section. Get medical help right||
0912|032|W|away if any of these very serious side effects occur:||
0912|033|W|slow/shallow breathing, unusual lightheadedness, severe||
0912|034|W|drowsiness/dizziness, difficulty waking up.||
0912|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0912|036|W|or abuse. If someone accidentally swallows this drug, get medical||
0912|037|W|help right away.||
0912|038|W|   One ingredient in this product is acetaminophen. Taking too||
0912|039|W|much acetaminophen may cause serious (possibly fatal) liver||
0912|040|W|disease. Adults should not take more than 4000 milligrams (4||
0912|041|W|grams) of acetaminophen a day. People with liver problems and||
0912|042|W|children should take less acetaminophen. Ask your doctor or||
0912|043|W|pharmacist how much acetaminophen is safe to take.||
0912|044|W|   Do not use with any other drug containing acetaminophen||
0912|045|W|without asking your doctor or pharmacist first. Acetaminophen is||
0912|046|W|in many nonprescription and prescription medications (such as||
0912|047|W|pain/fever drugs or cough-and-cold products). Check the labels on||
0912|048|W|all your medicines to see if they contain acetaminophen, and ask||
0912|049|W|your pharmacist if you are unsure.||
0912|050|W|   Get medical help right away if you take too much acetaminophen||
0912|051|W|(overdose), even if you feel well. Overdose symptoms may include||
0912|052|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
0912|053|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
0912|054|W|   Daily alcohol use, especially when combined with||
0912|055|W|acetaminophen, may damage your liver. Avoid alcohol.||
0912|056|W|   Before using this medication, women of childbearing age should||
0912|057|W|talk with their doctor(s) about the risks and benefits. Tell your||
0912|058|W|doctor if you are pregnant or if you plan to become pregnant.||
0912|059|W|During pregnancy, this medication should be used only when||
0912|060|W|clearly needed. It may slightly increase the risk of birth||
0912|061|W|defects if used during the first two months of pregnancy. Also,||
0912|062|W|using it for a long time or in high doses near the expected||
0912|063|W|delivery date may harm the unborn baby. To lessen the risk, take||
0912|064|W|the smallest effective dose for the shortest possible time.||
0912|065|W|Babies born to mothers who use this drug for a long time may||
0912|066|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0912|067|W|doctor right away if you notice any symptoms in your newborn baby||
0912|068|W|such as crying that doesn't stop, slow/shallow breathing,||
0912|069|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0912|070|W|difficulty gaining weight.||
0912|071|W|   Children younger than 18 years should not use products that||
0912|072|W|contain codeine. Some children are more sensitive to codeine and||
0912|073|W|have had very serious (rarely fatal) breathing problems such as||
0912|074|W|slow/shallow breathing (see also Side Effects section). The risk||
0912|075|W|is greater in children who are obese or have breathing problems,||
0912|076|W|or after certain surgeries (including tonsil/adenoid removal).||
0912|077|W|Talk with your doctor or pharmacist about the risks and benefits||
0912|078|W|of this medication.||
0912|079|B|||
0912|080|U|USES:  See also Warning section.||
0912|081|U|   This combination medication is used to treat muscle spasm with||
0912|082|U|moderate to severe pain. Methocarbamol helps to relax the||
0912|083|U|muscles. Acetaminophen helps to decrease the pain. Codeine is an||
0912|084|U|opioid pain reliever that works in the brain to change how your||
0912|085|U|body feels and responds to pain.||
0912|086|B|||
0912|087|H|HOW TO USE:  See also Warning section.||
0912|088|H|   Take this medication by mouth as directed by your doctor. Do||
0912|089|H|not increase your dose or use this drug more often or for longer||
0912|090|H|than prescribed. Your condition will not improve any faster, and||
0912|091|H|your risk of side effects will increase. You may take this drug||
0912|092|H|with or without food. If you have nausea, it may help to take||
0912|093|H|this drug with food. Ask your doctor or pharmacist about other||
0912|094|H|ways to decrease nausea (such as lying down for 1 to 2 hours with||
0912|095|H|as little head movement as possible).||
0912|096|H|   The dosage is based on your medical condition and response to||
0912|097|H|treatment. Properly stop the medication when so directed.||
0912|098|H|   Pain medications work best if they are used as the first signs||
0912|099|H|of pain occur. If you wait until the pain has worsened, the||
0912|100|H|medication may not work as well.||
0912|101|H|   If you suddenly stop using this medication, you may have||
0912|102|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
0912|103|H|nose, nausea, sweating, muscle aches). To help prevent||
0912|104|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0912|105|H|more likely if you have used this medication for a long time or||
0912|106|H|in high doses. Tell your doctor or pharmacist right away if you||
0912|107|H|have withdrawal.||
0912|108|H|   When this medication is used for a long time, it may not work||
0912|109|H|as well. Talk with your doctor if this medication stops working||
0912|110|H|well.||
0912|111|H|   Though it helps many people, this medication may sometimes||
0912|112|H|cause addiction. This risk may be higher if you have a||
0912|113|H|mental/mood disorder or a substance use disorder (such as overuse||
0912|114|H|of or addiction to drugs/alcohol). Take this medication exactly||
0912|115|H|as prescribed to lower the risk of addiction. Ask your doctor or||
0912|116|H|pharmacist for more details.||
0912|117|H|   Tell your doctor if your condition lasts or if it gets worse,||
0912|118|H|or if you have any new pain.||
0912|119|B|||
0912|120|S|SIDE EFFECTS:  See also Warning section.||
0912|121|S|   Drowsiness, dizziness, lightheadedness, nausea/vomiting,||
0912|122|S|stomach upset, blurred vision, or constipation may occur. If any||
0912|123|S|of these effects last or get worse, tell your doctor or||
0912|124|S|pharmacist promptly.||
0912|125|S|   To prevent constipation, eat dietary fiber, drink enough||
0912|126|S|water, and exercise. You may also need to take a laxative. Ask||
0912|127|S|your pharmacist which type of laxative is right for you.||
0912|128|S|   To reduce the risk of dizziness and lightheadedness, get up||
0912|129|S|slowly when rising from a sitting or lying position.||
0912|130|S|   Remember that this medication has been prescribed because your||
0912|131|S|doctor has judged that the benefit to you is greater than the||
0912|132|S|risk of side effects. Many people using this medication do not||
0912|133|S|have serious side effects.||
0912|134|S|   Tell your doctor right away if you have any serious side||
0912|135|S|effects, including: slow heartbeat, interrupted breathing during||
0912|136|S|sleep (sleep apnea), mental/mood changes (such as forgetfulness),||
0912|137|S|difficulty urinating, signs of your adrenal glands not working||
0912|138|S|well (such as loss of appetite, unusual tiredness, weight loss),||
0912|139|S|trouble swallowing.||
0912|140|S|   Get medical help right away if you have any very serious side||
0912|141|S|effects, including: fainting, seizures.||
0912|142|S|   Codeine is changed into a strong opioid drug (morphine) in||
0912|143|S|your body. In some people, this change happens faster and more||
0912|144|S|completely than usual, which increases the risk of very serious||
0912|145|S|side effects. Get medical help right away if you notice any of||
0912|146|S|the following: slow/shallow breathing, severe||
0912|147|S|drowsiness/difficulty waking up, confusion.||
0912|148|S|   A very serious allergic reaction to this drug is rare.||
0912|149|S|However, get medical help right away if you notice any symptoms||
0912|150|S|of a serious allergic reaction, including: rash, itching/swelling||
0912|151|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0912|152|S|breathing.||
0912|153|S|   This is not a complete list of possible side effects. If you||
0912|154|S|notice other effects not listed above, contact your doctor or||
0912|155|S|pharmacist.||
0912|156|S|   In the US -||
0912|157|S|   Call your doctor for medical advice about side effects. You||
0912|158|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0912|159|S|www.fda.gov/medwatch.||
0912|160|S|   In Canada - Call your doctor for medical advice about side||
0912|161|S|effects. You may report side effects to Health Canada at||
0912|162|S|1-866-234-2345.||
0912|163|B|||
0912|164|P|PRECAUTIONS:  See also Warning section.||
0912|165|P|   Before taking this medication, tell your doctor or pharmacist||
0912|166|P|if you are allergic to methocarbamol, acetaminophen, or codeine;||
0912|167|P|or to other opioid pain medications (such as morphine); or if you||
0912|168|P|have any other allergies. This product may contain inactive||
0912|169|P|ingredients, which can cause allergic reactions or other||
0912|170|P|problems. Talk to your pharmacist for more details.||
0912|171|P|   Before using this medication, tell your doctor or pharmacist||
0912|172|P|your medical history, especially of: brain disorders (such as||
0912|173|P|head injury, tumor, seizures), breathing problems (such as||
0912|174|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0912|175|P|stomach/intestinal problems (such as blockage, constipation,||
0912|176|P|diarrhea due to infection, paralytic ileus), liver disease,||
0912|177|P|kidney disease, mental/mood disorders (such as confusion,||
0912|178|P|depression, thoughts of suicide), personal or family history of a||
0912|179|P|substance use disorder (such as overuse of or addiction to||
0912|180|P|drugs/alcohol), difficulty urinating (such as due to enlarged||
0912|181|P|prostate), gallbladder disease, disease of the pancreas||
0912|182|P|(pancreatitis), obesity.||
0912|183|P|   This drug may make you dizzy or drowsy or blur your vision.||
0912|184|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0912|185|P|drowsy. Do not drive, use machinery, or do anything that needs||
0912|186|P|alertness or clear vision until you can do it safely. Avoid||
0912|187|P|alcoholic beverages. Talk to your doctor if you are using||
0912|188|P|marijuana (cannabis).||
0912|189|P|   Before having surgery, tell your doctor or dentist about all||
0912|190|P|the products you use (including prescription drugs,||
0912|191|P|nonprescription drugs, and herbal products).||
0912|192|P|   Older adults may be more sensitive to the side effects of this||
0912|193|P|drug, especially confusion, dizziness, drowsiness, and||
0912|194|P|slow/shallow breathing. Drowsiness, dizziness, and confusion can||
0912|195|P|increase the risk of falling.||
0912|196|P|   During pregnancy, this medication should be used only when||
0912|197|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0912|198|P|benefits with your doctor.||
0912|199|P|   This medication passes into breast milk and may have||
0912|200|P|undesirable effects on a nursing infant, such as unusual||
0912|201|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
0912|202|P|limpness. Consult your doctor before breastfeeding.||
0912|203|B|||
0912|204|I|DRUG INTERACTIONS:  See also Warning section.||
0912|205|I|   Drug interactions may change how your medications work or||
0912|206|I|increase your risk for serious side effects. This document does||
0912|207|I|not contain all possible drug interactions. Keep a list of all||
0912|208|I|the products you use (including prescription/nonprescription||
0912|209|I|drugs and herbal products) and share it with your doctor and||
0912|210|I|pharmacist. Do not start, stop, or change the dosage of any||
0912|211|I|medicines without your doctor's approval.||
0912|212|I|   Some products that may interact with this drug include:||
0912|213|I|certain pain medications (mixed opioid agonist-antagonists such||
0912|214|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0912|215|I|samidorphan.||
0912|216|I|   The risk of serious side effects (such as slow/shallow||
0912|217|I|breathing, severe drowsiness/dizziness) may be increased if this||
0912|218|I|medication is taken with other products that may also cause||
0912|219|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0912|220|I|if you are taking other products such as other opioid pain or||
0912|221|I|cough relievers (such as morphine, hydrocodone), alcohol,||
0912|222|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0912|223|I|alprazolam, lorazepam, zolpidem), other muscle relaxants (such as||
0912|224|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0912|225|I|cetirizine, diphenhydramine).||
0912|226|I|   Check the labels on all your medicines (such as allergy or||
0912|227|I|cough-and-cold products) because they may contain ingredients||
0912|228|I|that cause drowsiness. Ask your pharmacist about using those||
0912|229|I|products safely.||
0912|230|I|   Other medications can affect the removal of this product from||
0912|231|I|your body, which may affect how this product works. Examples||
0912|232|I|include azole antifungals (such as ketoconazole), bupropion,||
0912|233|I|fluoxetine, levoketoconazole, macrolide antibiotics (such as||
0912|234|I|erythromycin), paroxetine, quinidine, rifamycins (such as||
0912|235|I|rifabutin, rifampin), ritonavir, certain drugs used to treat||
0912|236|I|seizures (such as carbamazepine, phenytoin), among others.||
0912|237|I|   This medication may interfere with certain lab tests (such as||
0912|238|I|5-HIAA/VMA urine screening test, amylase/lipase levels), possibly||
0912|239|I|causing false test results. Make sure lab personnel and all your||
0912|240|I|doctors know you use this drug.||
0912|241|B|||
0912|242|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0912|243|O|as passing out or trouble breathing, give them naloxone or||
0912|244|O|nalmefene if available, then call 911. If the person is awake and||
0912|245|O|has no symptoms, call a poison control center right away. US||
0912|246|O|residents can call 1-800-222-1222. Canada residents can call||
0912|247|O|1-844-764-7669. Symptoms of overdose may include: severe||
0912|248|O|drowsiness/dizziness, slow/shallow breathing, nausea, vomiting,||
0912|249|O|loss of appetite, sweating, stomach/abdominal pain, extreme||
0912|250|O|tiredness, yellowing eyes/skin, dark urine, seizures, coma.||
0912|251|B|||
0912|252|N|NOTES:  Do not share this medication with others. Sharing it is||
0912|253|N|against the law.||
0912|254|N|   This medication has been prescribed for your current condition||
0912|255|N|only. Do not use it later for another condition unless your||
0912|256|N|doctor directs you to do so. A different medication may be||
0912|257|N|necessary in that case.||
0912|258|B|||
0912|259|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0912|260|D|remember. If it is near the time of the next dose, skip the||
0912|261|D|missed dose. Take your next dose at the regular time. Do not||
0912|262|D|double the dose to catch up.||
0912|263|B|||
0912|264|R|STORAGE:  Store at room temperature away from light and moisture.||
0912|265|R|Do not store in the bathroom. Keep all medications away from||
0912|266|R|children and pets.||
0912|267|R|   Do not flush medications down the toilet or pour them into a||
0912|268|R|drain unless instructed to do so. Properly discard this product||
0912|269|R|when it is expired or no longer needed. Consult your pharmacist||
0912|270|R|or local waste disposal company.||
0912|271|B|||
0912|272|A|Information last revised August 2025.||
0912|273|A|Copyright(c) 2025 First Databank, Inc.||
0912|274|B|||
0913|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0913|002|Z|does NOT have all possible information about this product. This||
0913|003|Z|information does not assure that this product is safe, effective,||
0913|004|Z|or appropriate for you. This information is not individual||
0913|005|Z|medical advice and does not substitute for the advice of your||
0913|006|Z|health care professional. Always ask your health care||
0913|007|Z|professional for complete information about this product and your||
0913|008|Z|specific health needs.||
0913|009|B|||
0913|010|T|MINERAL OIL - ORAL||
0913|011|F|(MIN-er-al oyl)||
0913|012|B|||
0913|013|U|USES:  Mineral oil is used to treat constipation. It is known as||
0913|014|U|a lubricant laxative. It works by keeping water in the stool and||
0913|015|U|intestines. This helps to soften the stool and also makes it||
0913|016|U|easier for stool to pass through the intestines.||
0913|017|U|   This medication should not be used by older adults, children||
0913|018|U|younger than 6 years, or by people who are bedridden.||
0913|019|B|||
0913|020|H|HOW TO USE:  Take this medication by mouth as directed by your||
0913|021|H|doctor. If you are self-treating, follow all directions on the||
0913|022|H|product package. If you have any questions, ask your doctor or||
0913|023|H|pharmacist.||
0913|024|H|   Carefully measure the dose using a special measuring||
0913|025|H|device/spoon. Do not use a household spoon because you may not||
0913|026|H|get the correct dose.||
0913|027|H|   Some brands require shaking the bottle well before each dose.||
0913|028|H|Check your product package to see if your brand needs to be||
0913|029|H|shaken.||
0913|030|H|   Because this drug can interfere with the absorption of certain||
0913|031|H|vitamins (fat-soluble vitamins including A, D, E, K), take this||
0913|032|H|medication on an empty stomach. Also, do not take this medication||
0913|033|H|for more than 7 days unless directed by your doctor.||
0913|034|H|   Do not lie down right away after taking this medication.||
0913|035|H|   Dosage is based on your age, medical condition, and response||
0913|036|H|to treatment. Do not increase your dose or take this drug more||
0913|037|H|often than directed.||
0913|038|H|   This product may decrease the absorption of other medications||
0913|039|H|you may be taking. Take this product at least 2 hours from your||
0913|040|H|other medications. Ask your doctor or pharmacist for more||
0913|041|H|information or if you have any questions.||
0913|042|H|   It may take 6 to 8 hours before this medication causes a bowel||
0913|043|H|movement. Tell your doctor if your condition lasts or gets worse,||
0913|044|H|or if bleeding from the rectum occurs. If you think you may have||
0913|045|H|a serious medical problem, get medical help right away.||
0913|046|B|||
0913|047|S|SIDE EFFECTS:  Mineral oil may leak from the rectum, especially||
0913|048|S|when taken at high doses. The leakage may dirty clothes and cause||
0913|049|S|irritation/itching around the anus. Lowering or dividing the dose||
0913|050|S|may help decrease this problem. If any of these effects last or||
0913|051|S|get worse, tell your doctor or pharmacist promptly.||
0913|052|S|   If your doctor has directed you to use this medication,||
0913|053|S|remember that your doctor has judged that the benefit to you is||
0913|054|S|greater than the risk of side effects. Many people using this||
0913|055|S|medication do not have serious side effects.||
0913|056|S|   Tell your doctor right away if you have any serious side||
0913|057|S|effects, including: cough that doesn't go away, difficulty||
0913|058|S|breathing.||
0913|059|S|   A very serious allergic reaction to this drug is rare.||
0913|060|S|However, get medical help right away if you notice any symptoms||
0913|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0913|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0913|063|S|breathing.||
0913|064|S|   This is not a complete list of possible side effects. If you||
0913|065|S|notice other effects not listed above, contact your doctor or||
0913|066|S|pharmacist.||
0913|067|S|   In the US -||
0913|068|S|   Call your doctor for medical advice about side effects. You||
0913|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0913|070|S|www.fda.gov/medwatch.||
0913|071|S|   In Canada - Call your doctor for medical advice about side||
0913|072|S|effects. You may report side effects to Health Canada at||
0913|073|S|1-866-234-2345.||
0913|074|B|||
0913|075|P|PRECAUTIONS:  Before taking mineral oil, tell your doctor or||
0913|076|P|pharmacist if you are allergic to it; or if you have any other||
0913|077|P|allergies. This product may contain inactive ingredients, which||
0913|078|P|can cause allergic reactions or other problems. Talk to your||
0913|079|P|pharmacist for more details.||
0913|080|P|   Before using this medication, tell your doctor or pharmacist||
0913|081|P|your medical history, especially of: difficulty swallowing,||
0913|082|P|appendicitis or symptoms of appendicitis (such as||
0913|083|P|nausea/vomiting, sudden or unexplained stomach/abdominal pain), a||
0913|084|P|sudden change in bowel habits that lasts for longer than 2 weeks,||
0913|085|P|bleeding from the rectum, stomach problems (such as a hiatal||
0913|086|P|hernia, gastroparesis).||
0913|087|P|   Before having surgery, tell your doctor or dentist about all||
0913|088|P|the products you use (including prescription drugs,||
0913|089|P|nonprescription drugs, and herbal products).||
0913|090|P|   Older adults are at a greater risk of accidentally inhaling||
0913|091|P|this medication when trying to swallow it.||
0913|092|P|   During pregnancy, this medication should be used only when||
0913|093|P|clearly needed. Using it for long periods is not recommended||
0913|094|P|because of possible harm to the unborn baby. Discuss the risks||
0913|095|P|and benefits with your doctor.||
0913|096|P|   It is unknown if this medication passes into breast milk.||
0913|097|P|Consult your doctor before breastfeeding.||
0913|098|B|||
0913|099|I|DRUG INTERACTIONS:  See also How to Use Section.||
0913|100|I|   Drug interactions may change how your medications work or||
0913|101|I|increase your risk for serious side effects. This document does||
0913|102|I|not contain all possible drug interactions. Keep a list of all||
0913|103|I|the products you use (including prescription/nonprescription||
0913|104|I|drugs and herbal products) and share it with your doctor and||
0913|105|I|pharmacist. Do not start, stop, or change the dosage of any||
0913|106|I|medicines without your doctor's approval.||
0913|107|I|   Some products that may interact with this drug include: "blood||
0913|108|I|thinners" (such as warfarin), stool softeners (such as docusate).||
0913|109|B|||
0913|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0913|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0913|112|O|poison control center right away. US residents can call||
0913|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0913|114|B|||
0913|115|N|NOTES:  Keep all medical and lab appointments.||
0913|116|N|   Lifestyle changes that may prevent or relieve constipation||
0913|117|N|include exercising, drinking enough water, and eating a proper||
0913|118|N|diet with fiber-rich foods such as bran, fresh fruits/vegetables.||
0913|119|N|Talk to your doctor or pharmacist about lifestyle changes that||
0913|120|N|might benefit you.||
0913|121|B|||
0913|122|D|MISSED DOSE:  If your doctor has directed you to take this||
0913|123|D|medication on a regular schedule and you miss a dose, take it as||
0913|124|D|soon as you remember. If it is near the time of the next dose,||
0913|125|D|skip the missed dose. Take your next dose at the regular time. Do||
0913|126|D|not double the dose to catch up.||
0913|127|B|||
0913|128|R|STORAGE:  Store at room temperature away from light. Keep all||
0913|129|R|medications away from children and pets.||
0913|130|R|   Do not flush medications down the toilet or pour them into a||
0913|131|R|drain unless instructed to do so. Properly discard this product||
0913|132|R|when it is expired or no longer needed. Consult your pharmacist||
0913|133|R|or local waste disposal company.||
0913|134|B|||
0913|135|A|Information last revised May 2024.||
0913|136|A|Copyright(c) 2025 First Databank, Inc.||
0913|137|B|||
0914|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0914|002|Z|does NOT have all possible information about this product. This||
0914|003|Z|information does not assure that this product is safe, effective,||
0914|004|Z|or appropriate for you. This information is not individual||
0914|005|Z|medical advice and does not substitute for the advice of your||
0914|006|Z|health care professional. Always ask your health care||
0914|007|Z|professional for complete information about this product and your||
0914|008|Z|specific health needs.||
0914|009|B|||
0914|010|T|BRIMONIDINE/TIMOLOL SOLUTION - OPHTHALMIC||
0914|011|F|(bri-MOE-ni-deen/TIM-oh-lol)||
0914|012|B|||
0914|013|C|COMMON BRAND NAME(S): Combigan||
0914|014|B|||
0914|015|U|USES:  This combination medication is used to treat high pressure||
0914|016|U|inside the eye due to glaucoma (open-angle type) or other eye||
0914|017|U|diseases (such as ocular hypertension). Lowering high pressure||
0914|018|U|inside the eye helps to prevent blindness. This product contains||
0914|019|U|brimonidine and timolol. These medications are used together when||
0914|020|U|1 drug is not controlling the pressure inside the eye.||
0914|021|U|Brimonidine works by allowing better fluid drainage from within||
0914|022|U|the eye and also by decreasing the amount of fluid formed in the||
0914|023|U|eye. It belongs to a class of drugs known as alpha agonists.||
0914|024|U|Timolol is thought to work by decreasing the amount of fluid||
0914|025|U|formed in the eye. Timolol belongs to a class of drugs known as||
0914|026|U|beta blockers.||
0914|027|U|   This medication is not recommended for use in children less||
0914|028|U|than 2 years old due to an increased risk of serious side||
0914|029|U|effects. Ask the doctor or pharmacist for more details.||
0914|030|B|||
0914|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0914|032|H|from your pharmacist before you start using this product and each||
0914|033|H|time you get a refill. If you have any questions, ask your doctor||
0914|034|H|or pharmacist.||
0914|035|H|   To apply eye drops, wash your hands first. To avoid||
0914|036|H|contamination, do not touch the dropper tip or let it touch your||
0914|037|H|eye or any other surface.||
0914|038|H|   Use this medication in the affected eye(s) as directed by your||
0914|039|H|doctor, usually 2 times daily (12 hours apart).||
0914|040|H|   The preservative in this product may be absorbed by contact||
0914|041|H|lenses. If you wear contact lenses, remove them before using the||
0914|042|H|eye drops. Wait at least 15 minutes after using this medication||
0914|043|H|before putting in your contact lenses.||
0914|044|H|   Tilt your head back, look up, and pull down the lower eyelid||
0914|045|H|to make a pouch. Hold the dropper directly over your eye and||
0914|046|H|place 1 drop in the pouch. Look down and gently close your eyes||
0914|047|H|for 1 to 2 minutes. Place one finger at the corner of your eye||
0914|048|H|(near the nose) and apply gentle pressure. This will prevent the||
0914|049|H|medication from draining away from the eye. Try not to blink and||
0914|050|H|do not rub your eye. Repeat these steps for your other eye if so||
0914|051|H|directed.||
0914|052|H|   Do not rinse the dropper. Replace the dropper cap after each||
0914|053|H|use.||
0914|054|H|   If you are using another kind of eye medication (such as drops||
0914|055|H|or ointments), wait at least 10 minutes before applying other||
0914|056|H|medications. Use eye drops before eye ointments to allow the eye||
0914|057|H|drops to enter the eye.||
0914|058|H|   Wait several minutes for your vision to clear before driving||
0914|059|H|or operating machinery.||
0914|060|H|   Use this medication regularly in order to get the most benefit||
0914|061|H|from it. To help you remember, use it at the same times each day.||
0914|062|H|Keep using this medication even if you feel well. Most people||
0914|063|H|with glaucoma or high pressure in the eyes do not feel sick.||
0914|064|B|||
0914|065|S|SIDE EFFECTS:  Temporary blurred vision, temporary||
0914|066|S|burning/stinging/itching/redness of the eye, watery eyes, dry||
0914|067|S|eyes, dry mouth, feeling as if something is in the eye, headache,||
0914|068|S|dizziness, or drowsiness may occur. If any of these effects last||
0914|069|S|or get worse, tell your doctor or pharmacist promptly.||
0914|070|S|   Remember that your doctor has prescribed this medication||
0914|071|S|because the benefit to you is greater than the risk of side||
0914|072|S|effects. Many people using this medication do not have serious||
0914|073|S|side effects.||
0914|074|S|   Tell your doctor right away if you have any serious side||
0914|075|S|effects, including: vision changes, eye sensitivity to light, eye||
0914|076|S|pain/swelling/discharge, slow/irregular heartbeat, muscle||
0914|077|S|weakness, unusual tiredness, mental/mood changes,||
0914|078|S|coldness/numbness/pain in the hands or feet, swelling||
0914|079|S|ankles/feet, sudden unexplained weight gain, shortness of breath.||
0914|080|S|   Get medical help right away if you have any very serious side||
0914|081|S|effects, including: dizziness that doesn't stop, trouble||
0914|082|S|breathing, chest pain, weakness on one side of the body, trouble||
0914|083|S|speaking, confusion, fainting.||
0914|084|S|   A very serious allergic reaction to this drug is rare.||
0914|085|S|However, get medical help right away if you notice any symptoms||
0914|086|S|of a serious allergic reaction, including: rash, itching/swelling||
0914|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0914|088|S|breathing.||
0914|089|S|   This is not a complete list of possible side effects. If you||
0914|090|S|notice other effects not listed above, contact your doctor or||
0914|091|S|pharmacist.||
0914|092|S|   In the US -||
0914|093|S|   Call your doctor for medical advice about side effects. You||
0914|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0914|095|S|www.fda.gov/medwatch.||
0914|096|S|   In Canada - Call your doctor for medical advice about side||
0914|097|S|effects. You may report side effects to Health Canada at||
0914|098|S|1-866-234-2345.||
0914|099|B|||
0914|100|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0914|101|P|pharmacist if you are allergic to brimonidine or timolol; or to||
0914|102|P|apraclonidine; or if you have any other allergies. This product||
0914|103|P|may contain inactive ingredients, which can cause allergic||
0914|104|P|reactions or other problems. Talk to your pharmacist for more||
0914|105|P|details.||
0914|106|P|   Before using this medication, tell your doctor or pharmacist||
0914|107|P|your medical history, especially of: lung disease (such as||
0914|108|P|current or past asthma, severe chronic obstructive pulmonary||
0914|109|P|disease-COPD), certain types of irregular heartbeats (sinus||
0914|110|P|bradycardia, second- or third-degree AV block), heart disease||
0914|111|P|(severe heart failure, cardiogenic shock), kidney disease, liver||
0914|112|P|disease, blood vessel disease (such as thromboangiitis||
0914|113|P|obliterans, Raynaud's phenomenon), blood circulation disorders||
0914|114|P|(cerebral/coronary insufficiency), dizziness after standing||
0914|115|P|(orthostatic hypotension), diabetes, depression, overactive||
0914|116|P|thyroid (hyperthyroidism), muscle weakness disorders (such as||
0914|117|P|myasthenia gravis), severe allergies.||
0914|118|P|   If you develop an eye infection or injury, or have eye||
0914|119|P|surgery, check with your doctor about whether you should continue||
0914|120|P|to use your current bottle of this medication. You may be advised||
0914|121|P|to start using a new bottle.||
0914|122|P|   Before having surgery, tell your doctor or dentist about all||
0914|123|P|the products you use (including prescription drugs,||
0914|124|P|nonprescription drugs, and herbal products).||
0914|125|P|   This product may prevent the fast/pounding heartbeat you would||
0914|126|P|usually feel when your blood sugar level falls too low||
0914|127|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
0914|128|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
0914|129|P|blood sugar level, such as dizziness and sweating, are not||
0914|130|P|affected by this drug.||
0914|131|P|   If you have diabetes, this product may make it harder to||
0914|132|P|control your blood sugar levels. Check your blood sugar levels||
0914|133|P|regularly as directed by your doctor. Tell your doctor right away||
0914|134|P|if you have symptoms of high blood sugar such as increased||
0914|135|P|thirst/urination. Your doctor may need to adjust your diabetes||
0914|136|P|medication, exercise program, or diet.||
0914|137|P|   This drug may make you dizzy or drowsy or temporarily blur||
0914|138|P|your vision. Alcohol or marijuana (cannabis) can make you more||
0914|139|P|dizzy or drowsy. Do not drive, use machinery, or do anything that||
0914|140|P|needs alertness or clear vision until you can do it safely. Limit||
0914|141|P|alcoholic beverages. Talk to your doctor if you are using||
0914|142|P|marijuana (cannabis).||
0914|143|P|   During pregnancy, this medication should be used only when||
0914|144|P|clearly needed. Discuss the risks and benefits with your doctor.||
0914|145|P|   This medication passes into breast milk, but is unlikely to||
0914|146|P|harm a nursing infant. Consult your doctor before breastfeeding.||
0914|147|B|||
0914|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0914|149|I|medications work or increase your risk for serious side effects.||
0914|150|I|This document does not contain all possible drug interactions.||
0914|151|I|Keep a list of all the products you use (including||
0914|152|I|prescription/nonprescription drugs and herbal products) and share||
0914|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
0914|154|I|the dosage of any medicines without your doctor's approval.||
0914|155|I|   Some products that may interact with this drug include: beta||
0914|156|I|blockers taken by mouth (such as propranolol), certain||
0914|157|I|antidepressants (SSRIs such as fluoxetine, tricyclics such as||
0914|158|I|amitriptyline), digoxin, epinephrine, high blood pressure||
0914|159|I|medications (such as clonidine, methyldopa), quinidine.||
0914|160|I|   Tell your doctor or pharmacist if you are using other products||
0914|161|I|that cause drowsiness such as opioid pain or cough relievers||
0914|162|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
0914|163|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
0914|164|I|zolpidem), muscle relaxants (such as carisoprodol,||
0914|165|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0914|166|I|diphenhydramine).||
0914|167|I|   Check the labels on all your medicines (such as allergy or||
0914|168|I|cough-and-cold products) because they may contain ingredients||
0914|169|I|that cause drowsiness. Ask your pharmacist about using those||
0914|170|I|products safely.||
0914|171|B|||
0914|172|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0914|173|O|has overdosed and has serious symptoms such as passing out or||
0914|174|O|trouble breathing, call 911. Otherwise, call a poison control||
0914|175|O|center right away. US residents can call 1-800-222-1222. Canada||
0914|176|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0914|177|O|include: trouble breathing, slow heartbeat.||
0914|178|B|||
0914|179|N|NOTES:  Do not share this medication with others.||
0914|180|N|   Lab and/or medical tests (such as eye exams, measuring||
0914|181|N|intraocular pressure) should be done while you are using this||
0914|182|N|medication. Keep all medical and lab appointments. Consult your||
0914|183|N|doctor for more details.||
0914|184|B|||
0914|185|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0914|186|D|If it is near the time of the next dose, skip the missed dose.||
0914|187|D|Use your next dose at the regular time. Do not double the dose to||
0914|188|D|catch up.||
0914|189|B|||
0914|190|R|STORAGE:  Store at room temperature away from light. Keep all||
0914|191|R|medications away from children and pets.||
0914|192|R|   Do not flush medications down the toilet or pour them into a||
0914|193|R|drain unless instructed to do so. Properly discard this product||
0914|194|R|when it is expired or no longer needed. Consult your pharmacist||
0914|195|R|or local waste disposal company.||
0914|196|B|||
0914|197|A|Information last revised May 2024.||
0914|198|A|Copyright(c) 2025 First Databank, Inc.||
0914|199|B|||
0915|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0915|002|Z|does NOT have all possible information about this product. This||
0915|003|Z|information does not assure that this product is safe, effective,||
0915|004|Z|or appropriate for you. This information is not individual||
0915|005|Z|medical advice and does not substitute for the advice of your||
0915|006|Z|health care professional. Always ask your health care||
0915|007|Z|professional for complete information about this product and your||
0915|008|Z|specific health needs.||
0915|009|B|||
0915|010|T|CLOTRIMAZOLE - TOPICAL||
0915|011|F|(kloe-TRIM-a-zole)||
0915|012|B|||
0915|013|C|COMMON BRAND NAME(S): Lotrimin||
0915|014|B|||
0915|015|U|USES:  Clotrimazole is used to treat skin infections such as||
0915|016|U|athlete's foot, jock itch, ringworm, and other fungal skin||
0915|017|U|infections (candidiasis). This medication is also used to treat a||
0915|018|U|skin condition known as pityriasis (tinea versicolor), a fungal||
0915|019|U|infection that causes a lightening or darkening of the skin of||
0915|020|U|the neck, chest, arms, or legs. Clotrimazole is an azole||
0915|021|U|antifungal that works by preventing the growth of fungus.||
0915|022|B|||
0915|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0915|024|H|thoroughly dry the area to be treated. Apply this medication to||
0915|025|H|the affected skin, usually twice a day or as directed by your||
0915|026|H|doctor. The dosage and length of treatment depends on the type of||
0915|027|H|infection being treated. Do not apply this more often than||
0915|028|H|prescribed. Your condition will not clear faster, but side||
0915|029|H|effects may be increased.||
0915|030|H|   Apply enough medication to cover the affected area and some of||
0915|031|H|the surrounding skin. After applying this medication, wash your||
0915|032|H|hands. Do not wrap, cover or bandage the area unless directed to||
0915|033|H|do so by your doctor.||
0915|034|H|   Avoid getting this medication in your eyes.||
0915|035|H|   Use this medication regularly in order to get the most benefit||
0915|036|H|from it. Remember to use it at the same times each day.||
0915|037|H|   Continue to use this medication until the full prescribed||
0915|038|H|amount is finished, even if symptoms disappear after a few days.||
0915|039|H|Stopping the medication too early may result in a return of the||
0915|040|H|infection.||
0915|041|H|   Tell your doctor if your condition lasts after 4 weeks of||
0915|042|H|treatment or gets worse at any time.||
0915|043|B|||
0915|044|S|SIDE EFFECTS:  Burning, stinging, swelling, irritation, redness,||
0915|045|S|pimple-like bumps, tenderness, or flaking of the treated skin may||
0915|046|S|occur. If any of these effects last or get worse, notify your||
0915|047|S|doctor or pharmacist promptly.||
0915|048|S|   If your doctor has directed you to use this medication,||
0915|049|S|remember that your doctor has judged that the benefit to you is||
0915|050|S|greater than the risk of side effects. Many people using this||
0915|051|S|medication do not have serious side effects.||
0915|052|S|   Tell your doctor right away if you have any serious side||
0915|053|S|effects, including: blistering, oozing, open sores.||
0915|054|S|   A very serious allergic reaction to this drug is rare.||
0915|055|S|However, get medical help right away if you notice any symptoms||
0915|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0915|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0915|058|S|breathing.||
0915|059|S|   This is not a complete list of possible side effects. If you||
0915|060|S|notice other effects not listed above, contact your doctor or||
0915|061|S|pharmacist.||
0915|062|S|   In the US -||
0915|063|S|   Call your doctor for medical advice about side effects. You||
0915|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0915|065|S|www.fda.gov/medwatch.||
0915|066|S|   In Canada - Call your doctor for medical advice about side||
0915|067|S|effects. You may report side effects to Health Canada at||
0915|068|S|1-866-234-2345.||
0915|069|B|||
0915|070|P|PRECAUTIONS:  Before using clotrimazole, tell your doctor or||
0915|071|P|pharmacist if you are allergic to it; or to other azole||
0915|072|P|antifungals such as econazole, ketoconazole, or miconazole; or if||
0915|073|P|you have any other allergies. This product may contain inactive||
0915|074|P|ingredients, which can cause allergic reactions or other||
0915|075|P|problems. Talk to your pharmacist for more details.||
0915|076|P|   Before using this medication, tell your doctor or pharmacist||
0915|077|P|your medical history.||
0915|078|P|   Before having surgery, tell your doctor or dentist about all||
0915|079|P|the products you use (including prescription drugs,||
0915|080|P|nonprescription drugs, and herbal products).||
0915|081|P|   During pregnancy, this medication should be used only when||
0915|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
0915|083|P|   It is unknown if this drug passes into breast milk. Consult||
0915|084|P|your doctor before breastfeeding.||
0915|085|B|||
0915|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0915|087|I|medications work or increase your risk for serious side effects.||
0915|088|I|This document does not contain all possible drug interactions.||
0915|089|I|Keep a list of all the products you use (including||
0915|090|I|prescription/nonprescription drugs and herbal products) and share||
0915|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
0915|092|I|the dosage of any medicines without your doctor's approval.||
0915|093|B|||
0915|094|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0915|095|O|has overdosed and has serious symptoms such as passing out or||
0915|096|O|trouble breathing, call 911. Otherwise, call a poison control||
0915|097|O|center right away. US residents can call 1-800-222-1222. Canada||
0915|098|O|residents can call 1-844-764-7669.||
0915|099|B|||
0915|100|N|NOTES:  Do not share this medication with others.||
0915|101|N|   If your doctor has directed you to use this medication, use it||
0915|102|N|for your current condition only. Do not use it later for another||
0915|103|N|infection unless your doctor tells you to.||
0915|104|N|   When treating pityriasis, this medication may not cause an||
0915|105|N|immediate return to normal skin color. It may take several months||
0915|106|N|after treatment is completed for your natural skin color to||
0915|107|N|return.||
0915|108|B|||
0915|109|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0915|110|D|If it is near the time of the next dose, skip the missed dose.||
0915|111|D|Use your next dose at the regular time. Do not double the dose to||
0915|112|D|catch up.||
0915|113|B|||
0915|114|R|STORAGE:  Different brands/strengths of this medication may have||
0915|115|R|different storage requirements. Read the package labeling or ask||
0915|116|R|your pharmacist for the storage requirements for the product you||
0915|117|R|are using. Keep all medications away from children and pets.||
0915|118|R|   Do not flush medications down the toilet or pour them into a||
0915|119|R|drain unless instructed to do so. Properly discard this product||
0915|120|R|when it is expired or no longer needed. Consult your pharmacist||
0915|121|R|or local waste disposal company.||
0915|122|B|||
0915|123|A|Information last revised November 2025.||
0915|124|A|Copyright(c) 2025 First Databank, Inc.||
0915|125|B|||
0917|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0917|002|Z|does NOT have all possible information about this product. This||
0917|003|Z|information does not assure that this product is safe, effective,||
0917|004|Z|or appropriate for you. This information is not individual||
0917|005|Z|medical advice and does not substitute for the advice of your||
0917|006|Z|health care professional. Always ask your health care||
0917|007|Z|professional for complete information about this product and your||
0917|008|Z|specific health needs.||
0917|009|B|||
0917|010|T|GLICLAZIDE EXTENDED-RELEASE - ORAL||
0917|011|F|(GLICK-luh-zide)||
0917|012|B|||
0917|013|U|USES:  Gliclazide is used with a proper diet and exercise program||
0917|014|U|to control high blood sugar in people with type 2 diabetes.||
0917|015|U|Controlling high blood sugar helps prevent kidney damage,||
0917|016|U|blindness, nerve problems, loss of limbs, and sexual function||
0917|017|U|problems. Proper control of diabetes may also lessen your risk of||
0917|018|U|a heart attack or stroke. Gliclazide belongs to the class of||
0917|019|U|drugs known as sulfonylureas. It lowers blood sugar by causing||
0917|020|U|the release of your body's natural insulin.||
0917|021|B|||
0917|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0917|023|H|from your pharmacist before you start using gliclazide and each||
0917|024|H|time you get a refill. If you have any questions, ask your doctor||
0917|025|H|or pharmacist.||
0917|026|H|   Take this medication by mouth with breakfast as directed by||
0917|027|H|your doctor, usually once daily. The dosage is based on your||
0917|028|H|medical condition and response to treatment.||
0917|029|H|   Do not crush or chew extended-release tablets. Doing so can||
0917|030|H|release all of the drug at once, increasing the risk of side||
0917|031|H|effects. Also, do not split the tablets unless they have a score||
0917|032|H|line and your doctor or pharmacist tells you to do so. Swallow||
0917|033|H|the whole or split tablet without crushing or chewing.||
0917|034|H|   To reduce your risk of side effects, your doctor may direct||
0917|035|H|you to start this medication at a low dose and gradually increase||
0917|036|H|your dose. Follow your doctor's instructions carefully.||
0917|037|H|   Use this medication regularly to get the most benefit from it.||
0917|038|H|To help you remember, take it at the same time each day.||
0917|039|H|   Tell your doctor if your condition does not get better or if||
0917|040|H|it gets worse (your blood sugar is too high or too low).||
0917|041|B|||
0917|042|S|SIDE EFFECTS:  Nausea, stomach upset, or diarrhea may occur. If||
0917|043|S|any of these effects last or get worse, tell your doctor or||
0917|044|S|pharmacist promptly.||
0917|045|S|   Remember that this medication has been prescribed because your||
0917|046|S|doctor has judged that the benefit to you is greater than the||
0917|047|S|risk of side effects. Many people using this medication do not||
0917|048|S|have serious side effects.||
0917|049|S|   Tell your doctor right away if you have any serious side||
0917|050|S|effects, including: signs of infection (such as sore throat that||
0917|051|S|doesn't go away, fever, chills), easy bleeding/bruising, signs of||
0917|052|S|liver disease (such as stomach/abdominal pain, yellowing||
0917|053|S|eyes/skin, dark urine), unusual/sudden weight gain, mental/mood||
0917|054|S|changes, swelling hands/feet, unusual tiredness/weakness.||
0917|055|S|   This medication can cause low blood sugar (hypoglycemia). This||
0917|056|S|may occur if you do not get enough calories from food or if you||
0917|057|S|do unusually heavy exercise. Symptoms of low blood sugar include||
0917|058|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
0917|059|S|dizziness, or tingling hands/feet. It is a good habit to carry||
0917|060|S|glucose tablets or gel to treat low blood sugar. If you don't||
0917|061|S|have these reliable forms of glucose, rapidly raise your blood||
0917|062|S|sugar by eating a quick source of sugar such as table sugar,||
0917|063|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
0917|064|S|doctor right away about the reaction and the use of this product.||
0917|065|S|To help prevent low blood sugar, eat meals on a regular schedule,||
0917|066|S|and do not skip meals. Check with your doctor or pharmacist to||
0917|067|S|find out what you should do if you miss a meal.||
0917|068|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0917|069|S|thirst/urination. If these symptoms occur, tell your doctor right||
0917|070|S|away. Your doctor may need to adjust your diabetes medication,||
0917|071|S|exercise program, or diet.||
0917|072|S|   A very serious allergic reaction to this drug is rare.||
0917|073|S|However, get medical help right away if you notice any symptoms||
0917|074|S|of a serious allergic reaction, including: rash, itching/swelling||
0917|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0917|076|S|breathing.||
0917|077|S|   This is not a complete list of possible side effects. If you||
0917|078|S|notice other effects not listed above, contact your doctor or||
0917|079|S|pharmacist.||
0917|080|S|   In the US -||
0917|081|S|   Call your doctor for medical advice about side effects. You||
0917|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0917|083|S|www.fda.gov/medwatch.||
0917|084|S|   In Canada - Call your doctor for medical advice about side||
0917|085|S|effects. You may report side effects to Health Canada at||
0917|086|S|1-866-234-2345.||
0917|087|B|||
0917|088|P|PRECAUTIONS:  Before taking gliclazide, tell your doctor or||
0917|089|P|pharmacist if you are allergic to it; or to other sulfonylureas||
0917|090|P|(such as glipizide); or if you have any other allergies. This||
0917|091|P|product may contain inactive ingredients, which can cause||
0917|092|P|allergic reactions or other problems. Talk to your pharmacist for||
0917|093|P|more details.||
0917|094|P|   Before using this medication, tell your doctor or pharmacist||
0917|095|P|your medical history, especially of: bleeding problems, liver||
0917|096|P|problems, kidney problems, thyroid disease, a certain metabolic||
0917|097|P|problem (porphyria), certain hormonal conditions||
0917|098|P|(adrenal/pituitary insufficiency).||
0917|099|P|   You may experience blurred vision, dizziness, or drowsiness||
0917|100|P|due to extremely low or high blood sugar. Do not drive, use||
0917|101|P|machinery, or do anything that needs alertness or clear vision||
0917|102|P|until you can do it safely.||
0917|103|P|   Limit alcohol while taking this medication because it can||
0917|104|P|increase your risk of developing low blood sugar. Rarely, alcohol||
0917|105|P|can interact with gliclazide and cause a serious reaction with||
0917|106|P|symptoms such as facial flushing, nausea, vomiting, dizziness, or||
0917|107|P|stomach pain. If you notice any of these effects, tell your||
0917|108|P|doctor right away.||
0917|109|P|   It may be harder to control your blood sugar when your body is||
0917|110|P|stressed (such as due to fever, infection, injury, or surgery).||
0917|111|P|Consult your doctor because this may require a change in your||
0917|112|P|treatment plan, medications, or blood sugar testing.||
0917|113|P|   This medication may make you more sensitive to the sun. Limit||
0917|114|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0917|115|P|sunscreen and wear protective clothing when outdoors. Tell your||
0917|116|P|doctor right away if you get sunburned or have skin||
0917|117|P|blisters/redness.||
0917|118|P|   Before having surgery, tell your doctor or dentist about all||
0917|119|P|the products you use (including prescription drugs,||
0917|120|P|nonprescription drugs, and herbal products).||
0917|121|P|   Older adults may be more sensitive to the side effects of the||
0917|122|P|drug, especially low blood sugar.||
0917|123|P|   Tell your doctor if you are pregnant or plan to become||
0917|124|P|pregnant. You should not become pregnant while using gliclazide.||
0917|125|P|Gliclazide may harm an unborn baby. If you become pregnant, talk||
0917|126|P|to your doctor right away about the risks and benefits of this||
0917|127|P|medication.||
0917|128|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
0917|129|P|your doctor for managing your blood sugar while pregnant. Your||
0917|130|P|doctor may change your diabetes treatment during your pregnancy||
0917|131|P|(such as diet and medications including insulin).||
0917|132|P|   It is unknown if this drug passes into breast milk. Because of||
0917|133|P|the possible risk to the infant, breastfeeding is not recommended||
0917|134|P|while using this drug. Consult your doctor before breastfeeding.||
0917|135|B|||
0917|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0917|137|I|medications work or increase your risk for serious side effects.||
0917|138|I|This document does not contain all possible drug interactions.||
0917|139|I|Keep a list of all the products you use (including||
0917|140|I|prescription/nonprescription drugs and herbal products) and share||
0917|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
0917|142|I|the dosage of any medicines without your doctor's approval.||
0917|143|I|   Many drugs can affect your blood sugar, making it harder to||
0917|144|I|control. Before you start, stop, or change any medication, talk||
0917|145|I|with your doctor or pharmacist about how the medication may||
0917|146|I|affect your blood sugar. Check your blood sugar regularly as||
0917|147|I|directed and share the results with your doctor. Tell your doctor||
0917|148|I|right away if you have symptoms of high or low blood sugar. (See||
0917|149|I|also Side Effects section.) Your doctor may need to adjust your||
0917|150|I|diabetes medication, exercise program, or diet.||
0917|151|I|   Beta blocker medications (such as metoprolol, propranolol,||
0917|152|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0917|153|I|heartbeat you would usually feel when your blood sugar falls too||
0917|154|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0917|155|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0917|156|B|||
0917|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0917|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0917|159|O|poison control center right away. US residents can call||
0917|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0917|161|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
0917|162|O|sweating, loss of consciousness.||
0917|163|B|||
0917|164|N|NOTES:  Do not share this medication with others.||
0917|165|N|   Attend a diabetes education program to learn more about how to||
0917|166|N|manage your diabetes with medications, diet, exercise, and||
0917|167|N|regular medical exams.||
0917|168|N|   Learn the symptoms of high and low blood sugar and how to||
0917|169|N|treat low blood sugar. Check your blood sugar regularly as||
0917|170|N|directed.||
0917|171|N|   Lab and/or medical tests (such as kidney/liver function,||
0917|172|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
0917|173|N|should be done while you are taking this medication. Keep all||
0917|174|N|medical and lab appointments.||
0917|175|B|||
0917|176|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
0917|177|D|next dose at the regular time. Do not double the dose to catch||
0917|178|D|up.||
0917|179|B|||
0917|180|R|STORAGE:  Store at room temperature away from light and moisture.||
0917|181|R|Do not store in the bathroom. Keep all medications away from||
0917|182|R|children and pets.||
0917|183|R|   Do not flush medications down the toilet or pour them into a||
0917|184|R|drain unless instructed to do so. Properly discard this product||
0917|185|R|when it is expired or no longer needed. Consult your pharmacist||
0917|186|R|or local waste disposal company.||
0917|187|B|||
0917|188|M|MEDICAL ALERT:  Your condition can cause complications in a||
0917|189|M|medical emergency. For information about enrolling in MedicAlert,||
0917|190|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0917|191|B|||
0917|192|A|Information last revised April 2025.||
0917|193|A|Copyright(c) 2025 First Databank, Inc.||
0917|194|B|||
0919|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0919|002|Z|does NOT have all possible information about this product. This||
0919|003|Z|information does not assure that this product is safe, effective,||
0919|004|Z|or appropriate for you. This information is not individual||
0919|005|Z|medical advice and does not substitute for the advice of your||
0919|006|Z|health care professional. Always ask your health care||
0919|007|Z|professional for complete information about this product and your||
0919|008|Z|specific health needs.||
0919|009|B|||
0919|010|T|NAPROXEN SUSTAINED-RELEASE - ORAL||
0919|011|F|(nah-PROX-en)||
0919|012|B|||
0919|013|C|COMMON BRAND NAME(S): Naprelan||
0919|014|B|||
0919|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
0919|016|W|naproxen) may rarely increase the risk for a heart attack or||
0919|017|W|stroke. This effect can happen at any time while taking this drug||
0919|018|W|but is more likely if you take it for a long time. The risk may||
0919|019|W|be greater in older adults or if you have heart disease or||
0919|020|W|increased risk for heart disease (for example, due to smoking,||
0919|021|W|family history of heart disease, or conditions such as high blood||
0919|022|W|pressure or diabetes). Do not take this drug right before or||
0919|023|W|after heart bypass surgery (CABG).||
0919|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
0919|025|W|from the stomach or intestines. This effect can occur without||
0919|026|W|warning at any time while taking this drug. Older adults may be||
0919|027|W|at higher risk for this effect.||
0919|028|W|   Stop taking naproxen and get medical help right away if you||
0919|029|W|notice any of these rare but serious side effects:||
0919|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
0919|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
0919|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
0919|033|W|side of the body, trouble speaking, sudden vision changes.||
0919|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
0919|035|W|of taking this drug.||
0919|036|B|||
0919|037|U|USES:  Naproxen is used to relieve pain from various conditions.||
0919|038|U|It also reduces pain, swelling, and joint stiffness caused by||
0919|039|U|arthritis, bursitis, and gout attacks. This medication is known||
0919|040|U|as a nonsteroidal anti-inflammatory drug (NSAID). It works by||
0919|041|U|blocking your body's production of certain natural substances||
0919|042|U|that cause inflammation.||
0919|043|U|   If you are treating a chronic condition such as arthritis, ask||
0919|044|U|your doctor about non-drug treatments and/or using other||
0919|045|U|medications to treat your pain. See also Warning section.||
0919|046|U|   Some brands of sustained-release naproxen take longer to be||
0919|047|U|absorbed and are not recommended for pain that needs quick relief||
0919|048|U|(such as during a gout attack). Ask your doctor or pharmacist if||
0919|049|U|you have questions about your particular brand.||
0919|050|B|||
0919|051|H|HOW TO USE:  Read the Medication Guide provided by your||
0919|052|H|pharmacist before you start using naproxen and each time you get||
0919|053|H|a refill. If you have any questions, ask your doctor or||
0919|054|H|pharmacist.||
0919|055|H|   Take this medication by mouth as directed by your doctor,||
0919|056|H|usually once daily with a full glass of water (8 ounces/240||
0919|057|H|milliliters). Do not lie down for at least 10 minutes after||
0919|058|H|taking this drug. To prevent stomach upset, take this medication||
0919|059|H|with food, milk, or an antacid.||
0919|060|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
0919|061|H|Doing so can release all of the drug at once, increasing the risk||
0919|062|H|of side effects.||
0919|063|H|   The dosage is based on your medical condition and response to||
0919|064|H|treatment. Your doctor will usually start you on the short-acting||
0919|065|H|form of this medication and switch you over to this form if it||
0919|066|H|provides the proper dose and if your pain/condition lasts for a||
0919|067|H|long time. To reduce your risk of stomach bleeding and other side||
0919|068|H|effects, take this medication at the lowest effective dose for||
0919|069|H|the shortest possible time. Do not increase your dose or take||
0919|070|H|this drug more often than directed. For ongoing conditions such||
0919|071|H|as arthritis, keep taking this medication as directed by your||
0919|072|H|doctor.||
0919|073|H|   Use this medication regularly to get the most benefit from it.||
0919|074|H|To help you remember, take it at the same time each day.||
0919|075|H|   For certain conditions (such as arthritis), it may take up to||
0919|076|H|two weeks of taking this drug regularly until you get the full||
0919|077|H|benefit.||
0919|078|H|   Tell your doctor if your condition does not get better or if||
0919|079|H|it gets worse.||
0919|080|B|||
0919|081|S|SIDE EFFECTS:  See also Warning section.||
0919|082|S|   Upset stomach, nausea, heartburn, headache, drowsiness, or||
0919|083|S|dizziness may occur. If any of these effects last or get worse,||
0919|084|S|tell your doctor or pharmacist promptly.||
0919|085|S|   Remember that this medication has been prescribed because your||
0919|086|S|doctor has judged that the benefit to you is greater than the||
0919|087|S|risk of side effects. Many people using this medication do not||
0919|088|S|have serious side effects.||
0919|089|S|   This medication may raise your blood pressure. Check your||
0919|090|S|blood pressure regularly and tell your doctor if the results are||
0919|091|S|high.||
0919|092|S|   Tell your doctor right away if you have any serious side||
0919|093|S|effects, including: easy bruising/bleeding, difficult/painful||
0919|094|S|swallowing, hearing changes (such as ringing in the ears),||
0919|095|S|mental/mood changes, signs of kidney problems (such as change in||
0919|096|S|the amount of urine), vision changes, symptoms of heart failure||
0919|097|S|(such as swelling ankles/feet, unusual tiredness, unusual/sudden||
0919|098|S|weight gain).||
0919|099|S|   This drug may rarely cause serious (possibly fatal) liver||
0919|100|S|disease. Get medical help right away if you have any symptoms of||
0919|101|S|liver damage, including: dark urine, nausea/vomiting that doesn't||
0919|102|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
0919|103|S|eyes/skin.||
0919|104|S|   A very serious allergic reaction to this drug is rare.||
0919|105|S|However, get medical help right away if you notice any symptoms||
0919|106|S|of a serious allergic reaction, including: fever, swollen lymph||
0919|107|S|nodes, rash, itching/swelling (especially of the||
0919|108|S|face/tongue/throat), severe dizziness, trouble breathing.||
0919|109|S|   This is not a complete list of possible side effects. If you||
0919|110|S|notice other effects not listed above, contact your doctor or||
0919|111|S|pharmacist.||
0919|112|S|   In the US -||
0919|113|S|   Call your doctor for medical advice about side effects. You||
0919|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0919|115|S|www.fda.gov/medwatch.||
0919|116|S|   In Canada - Call your doctor for medical advice about side||
0919|117|S|effects. You may report side effects to Health Canada at||
0919|118|S|1-866-234-2345.||
0919|119|B|||
0919|120|P|PRECAUTIONS:  Before taking naproxen, tell your doctor or||
0919|121|P|pharmacist if you are allergic to it; or to aspirin or other||
0919|122|P|NSAIDs (such as ibuprofen, celecoxib); or if you have any other||
0919|123|P|allergies. This product may contain inactive ingredients, which||
0919|124|P|can cause allergic reactions or other problems. Talk to your||
0919|125|P|pharmacist for more details.||
0919|126|P|   Before taking this medication, tell your doctor or pharmacist||
0919|127|P|your medical history, especially of: asthma (including a history||
0919|128|P|of worsening breathing after taking aspirin or other NSAIDs),||
0919|129|P|blood disorders (such as anemia, bleeding/clotting problems),||
0919|130|P|growths in the nose (nasal polyps), heart disease (such as||
0919|131|P|previous heart attack), high blood pressure, liver disease,||
0919|132|P|stroke, throat/stomach/intestinal problems (such as bleeding,||
0919|133|P|heartburn, ulcers).||
0919|134|P|   Kidney problems can sometimes occur with the use of NSAID||
0919|135|P|medications, including naproxen. Problems are more likely to||
0919|136|P|occur if you are dehydrated, have heart failure or kidney||
0919|137|P|disease, are an older adult, or if you take certain medications||
0919|138|P|(see also Drug Interactions section). Drink plenty of fluids as||
0919|139|P|directed by your doctor to prevent dehydration and tell your||
0919|140|P|doctor right away if you have a change in the amount of urine.||
0919|141|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0919|142|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0919|143|P|machinery, or do anything that needs alertness until you can do||
0919|144|P|it safely. Talk to your doctor if you are using marijuana||
0919|145|P|(cannabis).||
0919|146|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
0919|147|P|and tobacco, especially when combined with this medicine, may||
0919|148|P|increase your risk for stomach bleeding. Limit alcohol and stop||
0919|149|P|smoking. Consult your doctor or pharmacist for more information.||
0919|150|P|   This medication may make you more sensitive to the sun. Limit||
0919|151|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0919|152|P|sunscreen and wear protective clothing when outdoors. Tell your||
0919|153|P|doctor right away if you get sunburned or have skin||
0919|154|P|blisters/redness.||
0919|155|P|   Some naproxen products contain salt (sodium). Tell your doctor||
0919|156|P|if you are on a salt-restricted diet.||
0919|157|P|   Before having surgery, tell your doctor or dentist about all||
0919|158|P|the products you use (including prescription drugs,||
0919|159|P|nonprescription drugs, and herbal products).||
0919|160|P|   Older adults may be at greater risk for stomach/intestinal||
0919|161|P|bleeding, kidney problems, heart attack, and stroke while using||
0919|162|P|this drug.||
0919|163|P|   Before using this medication, women of childbearing age should||
0919|164|P|talk with their doctor(s) about the benefits and risks. Tell your||
0919|165|P|doctor if you are pregnant or if you plan to become pregnant.||
0919|166|P|This medication may harm an unborn baby and cause problems with||
0919|167|P|normal labor/delivery. It is not recommended for use in pregnancy||
0919|168|P|from 20 weeks until delivery. If your doctor decides that you||
0919|169|P|need to use this medication between 20 and 30 weeks of pregnancy,||
0919|170|P|you should use the lowest effective dose for the shortest||
0919|171|P|possible time. You should not use this medication after 30 weeks||
0919|172|P|of pregnancy.||
0919|173|P|   This drug passes into breast milk and may have undesirable||
0919|174|P|effects on a nursing infant. Consult your doctor before||
0919|175|P|breastfeeding.||
0919|176|B|||
0919|177|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0919|178|I|medications work or increase your risk for serious side effects.||
0919|179|I|This document does not contain all possible drug interactions.||
0919|180|I|Keep a list of all the products you use (including||
0919|181|I|prescription/nonprescription drugs and herbal products) and share||
0919|182|I|it with your doctor and pharmacist. Do not start, stop, or change||
0919|183|I|the dosage of any medicines without your doctor's approval.||
0919|184|I|   Products that may interact with this drug include: aliskiren,||
0919|185|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
0919|186|I|receptor blockers (such as losartan, valsartan), cidofovir,||
0919|187|I|corticosteroids (such as prednisone), lithium, "water pills"||
0919|188|I|(diuretics such as furosemide).||
0919|189|I|   This medication may increase the risk of bleeding when taken||
0919|190|I|with other drugs that also may cause bleeding. Examples include||
0919|191|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
0919|192|I|dabigatran/enoxaparin/warfarin, among others.||
0919|193|I|   Check all prescription and nonprescription medicine labels||
0919|194|I|carefully since many medications contain pain relievers/fever||
0919|195|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
0919|196|I|ketorolac). These drugs are similar to naproxen and may increase||
0919|197|I|your risk of side effects if taken together. However, if your||
0919|198|I|doctor has told you to take low-dose aspirin to prevent heart||
0919|199|I|attack or stroke (usually 81-162 milligrams a day), you should||
0919|200|I|keep taking the aspirin unless your doctor tells you not to.||
0919|201|I|Daily use of naproxen may decrease aspirin's ability to prevent||
0919|202|I|heart attack/stroke. Talk with your doctor about the risks and||
0919|203|I|benefits. Ask about other medications that can be used to treat||
0919|204|I|pain/fever.||
0919|205|I|   This medication may interfere with certain lab tests, possibly||
0919|206|I|causing false test results. Make sure lab personnel and all your||
0919|207|I|doctors know you use this drug.||
0919|208|B|||
0919|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0919|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0919|211|O|poison control center right away. US residents can call||
0919|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0919|213|O|Symptoms of overdose may include: severe stomach pain, extreme||
0919|214|O|drowsiness, seizures.||
0919|215|B|||
0919|216|N|NOTES:  Do not share this medication with others.||
0919|217|N|   Lab and/or medical tests (such as blood pressure, complete||
0919|218|N|blood count, liver/kidney function) may be done while you are||
0919|219|N|taking this medication. Keep all medical and lab appointments.||
0919|220|N|Consult your doctor for more details.||
0919|221|N|   If you have arthritis, lifestyle changes (such as weight loss||
0919|222|N|if needed, strengthening/conditioning exercises) may help improve||
0919|223|N|your flexibility and joint function. Consult your doctor for||
0919|224|N|specific instructions.||
0919|225|B|||
0919|226|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0919|227|D|remember. If it is near the time of the next dose, skip the||
0919|228|D|missed dose. Take your next dose at the regular time. Do not||
0919|229|D|double the dose to catch up.||
0919|230|B|||
0919|231|R|STORAGE:  Store at room temperature away from light and moisture.||
0919|232|R|Do not store in the bathroom. Keep all medications away from||
0919|233|R|children and pets.||
0919|234|R|   Do not flush medications down the toilet or pour them into a||
0919|235|R|drain unless instructed to do so. Properly discard this product||
0919|236|R|when it is expired or no longer needed. Consult your pharmacist||
0919|237|R|or local waste disposal company.||
0919|238|B|||
0919|239|A|Information last revised October 2024.||
0919|240|A|Copyright(c) 2025 First Databank, Inc.||
0919|241|B|||
0921|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0921|002|Z|does NOT have all possible information about this product. This||
0921|003|Z|information does not assure that this product is safe, effective,||
0921|004|Z|or appropriate for you. This information is not individual||
0921|005|Z|medical advice and does not substitute for the advice of your||
0921|006|Z|health care professional. Always ask your health care||
0921|007|Z|professional for complete information about this product and your||
0921|008|Z|specific health needs.||
0921|009|B|||
0921|010|T|ESOMEPRAZOLE DELAYED-RELEASE PACKET - ORAL||
0921|011|F|(ES-oh-MEP-ra-zole)||
0921|012|B|||
0921|013|C|COMMON BRAND NAME(S): Nexium||
0921|014|B|||
0921|015|U|USES:  Esomeprazole is used to treat certain stomach and||
0921|016|U|esophagus problems (such as acid reflux, ulcers). It works by||
0921|017|U|decreasing the amount of acid your stomach makes. It relieves||
0921|018|U|symptoms such as heartburn, difficulty swallowing, and cough.||
0921|019|U|This medication helps heal acid damage to the stomach and||
0921|020|U|esophagus, helps prevent ulcers, and may help prevent cancer of||
0921|021|U|the esophagus. Esomeprazole belongs to a class of drugs known as||
0921|022|U|proton pump inhibitors (PPIs).||
0921|023|B|||
0921|024|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0921|025|H|Patient Information Leaflet provided by your pharmacist before||
0921|026|H|you start taking esomeprazole and each time you get a refill. If||
0921|027|H|you have any questions, ask your doctor or pharmacist.||
0921|028|H|   Take this medication by mouth as directed by your doctor,||
0921|029|H|usually once daily, at least 1 hour before a meal. This||
0921|030|H|medication may also be given through a tube into the stomach||
0921|031|H|(nasogastric or gastric tube). The dosage and length of treatment||
0921|032|H|are based on your medical condition and response to treatment.||
0921|033|H|Children's dosage may be based on weight.||
0921|034|H|   If you are taking the 2.5-milligram-strength or||
0921|035|H|5-milligram-strength packets by mouth, empty the contents of a||
0921|036|H|packet into a container with 1 teaspoon (5 milliliters) of water.||
0921|037|H|Stir the mixture well and leave it for 2 to 3 minutes to thicken.||
0921|038|H|Stir again and drink all of the mixture within 30 minutes. If any||
0921|039|H|medication remains in the container, add more water, stir, and||
0921|040|H|drink right away to make sure you take the entire dose.||
0921|041|H|   If you are taking any other strength of this medication, empty||
0921|042|H|the contents of a packet into a container with 1 tablespoon (half||
0921|043|H|an ounce or 15 milliliters) of water. Stir the mixture well and||
0921|044|H|leave it for 2 to 3 minutes to thicken. Stir again and drink all||
0921|045|H|of the mixture within 30 minutes. If any medication remains in||
0921|046|H|the container, add more water, stir, and drink right away to make||
0921|047|H|sure you take the entire dose.||
0921|048|H|   Do not crush or chew the medication granules. Doing so may||
0921|049|H|destroy the drug.||
0921|050|H|   If you are giving this medication through a nasogastric or||
0921|051|H|gastric tube, ask your health care professional for detailed||
0921|052|H|instructions on how to properly mix and give it.||
0921|053|H|   If needed, antacids may be taken along with this medication.||
0921|054|H|If you are also taking sucralfate, take esomeprazole at least 30||
0921|055|H|minutes before sucralfate.||
0921|056|H|   Use this medication regularly to get the most benefit from it.||
0921|057|H|To help you remember, take it at the same time each day. Continue||
0921|058|H|to take this medication for the prescribed length of treatment||
0921|059|H|even if you are feeling better.||
0921|060|H|   Tell your doctor if your condition lasts or gets worse. The||
0921|061|H|risk of side effects goes up over time. Ask your doctor how long||
0921|062|H|you should take this medication.||
0921|063|B|||
0921|064|S|SIDE EFFECTS:  See also Precautions section.||
0921|065|S|   Headache or abdominal pain may occur. If any of these effects||
0921|066|S|last or get worse, tell your doctor or pharmacist promptly.||
0921|067|S|   Remember that this medication has been prescribed because your||
0921|068|S|doctor has judged that the benefit to you is greater than the||
0921|069|S|risk of side effects. Many people using this medication do not||
0921|070|S|have serious side effects.||
0921|071|S|   Tell your doctor right away if you have any serious side||
0921|072|S|effects, including: symptoms of a low magnesium blood level (such||
0921|073|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
0921|074|S|(such as rash on nose and cheeks, new or worsening joint pain),||
0921|075|S|signs of kidney problems (such as change in the amount of urine,||
0921|076|S|pink/bloody urine).||
0921|077|S|   This medication may rarely cause a severe intestinal condition||
0921|078|S|due to a bacteria called C. difficile. This condition may occur||
0921|079|S|during treatment or weeks to months after treatment has stopped.||
0921|080|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0921|081|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0921|082|S|stool.||
0921|083|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0921|084|S|products because they may make symptoms worse.||
0921|085|S|   Rarely, proton pump inhibitors (such as esomeprazole) have||
0921|086|S|caused vitamin B-12 deficiency. The risk is increased if they are||
0921|087|S|taken every day for a long time (3 years or longer). Tell your||
0921|088|S|doctor right away if you develop symptoms of vitamin B-12||
0921|089|S|deficiency (such as unusual weakness, sore tongue, or||
0921|090|S|numbness/tingling of the hands/feet).||
0921|091|S|   A very serious allergic reaction to this drug is rare.||
0921|092|S|However, get medical help right away if you notice any symptoms||
0921|093|S|of a serious allergic reaction, including: fever, swollen lymph||
0921|094|S|nodes, rash, itching/swelling (especially of the||
0921|095|S|face/tongue/throat), severe dizziness, trouble breathing.||
0921|096|S|   This is not a complete list of possible side effects. If you||
0921|097|S|notice other effects not listed above, contact your doctor or||
0921|098|S|pharmacist.||
0921|099|S|   In the US -||
0921|100|S|   Call your doctor for medical advice about side effects. You||
0921|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0921|102|S|www.fda.gov/medwatch.||
0921|103|S|   In Canada - Call your doctor for medical advice about side||
0921|104|S|effects. You may report side effects to Health Canada at||
0921|105|S|1-866-234-2345.||
0921|106|B|||
0921|107|P|PRECAUTIONS:  Before taking esomeprazole, tell your doctor or||
0921|108|P|pharmacist if you are allergic to it; or to other PPIs (such as||
0921|109|P|lansoprazole, omeprazole); or if you have any other allergies.||
0921|110|P|This product may contain inactive ingredients, which can cause||
0921|111|P|allergic reactions or other problems. Talk to your pharmacist for||
0921|112|P|more details.||
0921|113|P|   Before using this medication, tell your doctor or pharmacist||
0921|114|P|your medical history, especially of: liver disease, lupus.||
0921|115|P|   Some symptoms may actually be signs of a more serious||
0921|116|P|condition. Get medical help right away if you have: heartburn||
0921|117|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
0921|118|P|pain (especially with shortness of breath, unusual sweating),||
0921|119|P|unexplained weight loss.||
0921|120|P|   Before having surgery, tell your doctor or dentist about all||
0921|121|P|the products you use (including prescription drugs,||
0921|122|P|nonprescription drugs, and herbal products).||
0921|123|P|   Proton pump inhibitors (such as esomeprazole) may increase||
0921|124|P|your risk for bone fractures, especially with longer use, higher||
0921|125|P|doses, and in older adults. Talk with your doctor or pharmacist||
0921|126|P|about ways to prevent bone loss/fracture, such as by taking||
0921|127|P|calcium (such as calcium citrate) and vitamin D supplements.||
0921|128|P|   Older adults may be more sensitive to the side effects of this||
0921|129|P|drug, especially bone loss and fractures (see above), and C.||
0921|130|P|difficile infection (see Side Effects section).||
0921|131|P|   Children may be more sensitive to the side effects of this||
0921|132|P|drug, especially fever, cough, and infections of the||
0921|133|P|nose/throat/airways.||
0921|134|P|   During pregnancy, this medication should be used only when||
0921|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
0921|136|P|   It is unknown if this medication passes into breast milk.||
0921|137|P|However, similar drugs pass into breast milk. The effects on a||
0921|138|P|nursing infant are unknown. Consult your doctor before||
0921|139|P|breastfeeding.||
0921|140|B|||
0921|141|I|DRUG INTERACTIONS:  See also How to Use section.||
0921|142|I|   Drug interactions may change how your medications work or||
0921|143|I|increase your risk for serious side effects. This document does||
0921|144|I|not contain all possible drug interactions. Keep a list of all||
0921|145|I|the products you use (including prescription/nonprescription||
0921|146|I|drugs and herbal products) and share it with your doctor and||
0921|147|I|pharmacist. Do not start, stop, or change the dosage of any||
0921|148|I|medicines without your doctor's approval.||
0921|149|I|   Some products that may interact with this drug include:||
0921|150|I|clopidogrel, methotrexate (especially high-dose treatment),||
0921|151|I|rifampin, St John's wort.||
0921|152|I|   Some products need stomach acid so that the body can absorb||
0921|153|I|them properly. Esomeprazole decreases stomach acid, so it may||
0921|154|I|change how well these products work. Some affected products||
0921|155|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
0921|156|I|pazopanib, rilpivirine, sparsentan, certain azole antifungals||
0921|157|I|(itraconazole, ketoconazole, posaconazole), among others.||
0921|158|I|   Esomeprazole is very similar to omeprazole. Do not use any||
0921|159|I|medications containing omeprazole while using esomeprazole.||
0921|160|I|   This medication may interfere with certain lab tests, possibly||
0921|161|I|causing false test results. Make sure lab personnel and all your||
0921|162|I|doctors know you use this drug.||
0921|163|B|||
0921|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0921|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0921|166|O|poison control center right away. US residents can call||
0921|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0921|168|O|Symptoms of overdose may include: confusion, extreme sweating,||
0921|169|O|blurred vision, or unusually fast heartbeat.||
0921|170|B|||
0921|171|N|NOTES:  Do not share this medication with others.||
0921|172|N|   If your doctor instructs you to use this medication regularly||
0921|173|N|for a long time, lab and/or medical tests (such as a magnesium||
0921|174|N|blood test, vitamin B-12 levels) may be done while you are taking||
0921|175|N|this medication. Keep all medical and lab appointments. Consult||
0921|176|N|your doctor for more details.||
0921|177|B|||
0921|178|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0921|179|D|remember. If it is near the time of the next dose, skip the||
0921|180|D|missed dose. Take your next dose at the regular time. Do not||
0921|181|D|double the dose to catch up.||
0921|182|B|||
0921|183|R|STORAGE:  Store at room temperature away from moisture. Do not||
0921|184|R|open the packets until you are ready to use the medication. Do||
0921|185|R|not store in the bathroom. Keep all medications away from||
0921|186|R|children and pets.||
0921|187|R|   Do not flush medications down the toilet or pour them into a||
0921|188|R|drain unless instructed to do so. Properly discard this product||
0921|189|R|when it is expired or no longer needed. Consult your pharmacist||
0921|190|R|or local waste disposal company.||
0921|191|B|||
0921|192|A|Information last revised April 2025.||
0921|193|A|Copyright(c) 2025 First Databank, Inc.||
0921|194|B|||
0924|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0924|002|Z|does NOT have all possible information about this product. This||
0924|003|Z|information does not assure that this product is safe, effective,||
0924|004|Z|or appropriate for you. This information is not individual||
0924|005|Z|medical advice and does not substitute for the advice of your||
0924|006|Z|health care professional. Always ask your health care||
0924|007|Z|professional for complete information about this product and your||
0924|008|Z|specific health needs.||
0924|009|B|||
0924|010|T|ALISKIREN - ORAL||
0924|011|F|(AL-is-KYE-ren)||
0924|012|B|||
0924|013|C|COMMON BRAND NAME(S): Tekturna||
0924|014|B|||
0924|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
0924|016|W|unborn baby if used during pregnancy. It is important to prevent||
0924|017|W|pregnancy while taking this medication. Consult your doctor for||
0924|018|W|more details and to discuss the use of reliable forms of birth||
0924|019|W|control while taking this medication. If you are planning||
0924|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
0924|021|W|your doctor right away.||
0924|022|B|||
0924|023|U|USES:  This medication is used to treat high blood pressure||
0924|024|U|(hypertension). Lowering high blood pressure helps prevent||
0924|025|U|strokes, heart attacks, and kidney problems. Aliskiren works by||
0924|026|U|relaxing blood vessels so blood can flow more easily. It belongs||
0924|027|U|to a class of drugs known as direct renin inhibitors.||
0924|028|U|   This drug is not recommended for use in children younger than||
0924|029|U|2 years due to an increased risk of side effects.||
0924|030|B|||
0924|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0924|032|H|from your pharmacist before you start taking this medication and||
0924|033|H|each time you get a refill. If you have any questions, ask your||
0924|034|H|doctor or pharmacist.||
0924|035|H|   Take this medication by mouth as directed by your doctor,||
0924|036|H|usually once daily. You may take this medication with or without||
0924|037|H|food, but it is important to choose one way and take this||
0924|038|H|medication the same way with every dose. High-fat foods may||
0924|039|H|decrease how well this drug is absorbed by the body, so it is||
0924|040|H|best to avoid taking this medication with a high-fat meal.||
0924|041|H|   Do not take with fruit juices (such as apple, grapefruit, or||
0924|042|H|orange) since they may decrease the absorption of this drug.||
0924|043|H|   The dosage is based on your medical condition and response to||
0924|044|H|treatment.||
0924|045|H|   Take this medication regularly to get the most benefit from||
0924|046|H|it. To help you remember, take it at the same time each day. Keep||
0924|047|H|taking this medication even if you feel well. Most people with||
0924|048|H|high blood pressure do not feel sick. It may take 2 weeks before||
0924|049|H|you get the full benefit of this medication.||
0924|050|H|   Tell your doctor if your condition does not get better or if||
0924|051|H|it gets worse (your blood pressure readings remain high or||
0924|052|H|increase).||
0924|053|B|||
0924|054|S|SIDE EFFECTS:  Dizziness, lightheadedness, cough, diarrhea, or||
0924|055|S|tiredness may occur. If any of these effects last or get worse,||
0924|056|S|tell your doctor or pharmacist promptly.||
0924|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
0924|058|S|slowly when rising from a sitting or lying position.||
0924|059|S|   Remember that this medication has been prescribed because your||
0924|060|S|doctor has judged that the benefit to you is greater than the||
0924|061|S|risk of side effects. Many people using this medication do not||
0924|062|S|have serious side effects.||
0924|063|S|   Tell your doctor right away if you have any serious side||
0924|064|S|effects, including: fainting, symptoms of a high potassium blood||
0924|065|S|level (such as muscle weakness, slow/irregular heartbeat), signs||
0924|066|S|of kidney problems (such as change in the amount of urine).||
0924|067|S|   A very serious allergic reaction to this drug is rare.||
0924|068|S|However, get medical help right away if you notice any symptoms||
0924|069|S|of a serious allergic reaction, including: rash, itching/swelling||
0924|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0924|071|S|breathing.||
0924|072|S|   This is not a complete list of possible side effects. If you||
0924|073|S|notice other effects not listed above, contact your doctor or||
0924|074|S|pharmacist.||
0924|075|S|   In the US -||
0924|076|S|   Call your doctor for medical advice about side effects. You||
0924|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0924|078|S|www.fda.gov/medwatch.||
0924|079|S|   In Canada - Call your doctor for medical advice about side||
0924|080|S|effects. You may report side effects to Health Canada at||
0924|081|S|1-866-234-2345.||
0924|082|B|||
0924|083|P|PRECAUTIONS:  Before taking aliskiren, tell your doctor or||
0924|084|P|pharmacist if you are allergic to it; or if you have any other||
0924|085|P|allergies. This product may contain inactive ingredients, which||
0924|086|P|can cause allergic reactions or other problems. Talk to your||
0924|087|P|pharmacist for more details.||
0924|088|P|   Before using this medication, tell your doctor or pharmacist||
0924|089|P|your medical history, especially of: diabetes, kidney disease,||
0924|090|P|dehydration, high level of potassium in the blood.||
0924|091|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0924|092|P|can make you more dizzy. Do not drive, use machinery, or do||
0924|093|P|anything that needs alertness until you can do it safely. Limit||
0924|094|P|alcoholic beverages. Talk to your doctor if you are using||
0924|095|P|marijuana (cannabis).||
0924|096|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0924|097|P|and cause you to feel lightheaded. Tell your doctor if you have||
0924|098|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0924|099|P|of fluids unless your doctor tells you not to.||
0924|100|P|   This medication may increase your potassium levels. Before||
0924|101|P|using potassium supplements or salt substitutes that contain||
0924|102|P|potassium, consult your doctor or pharmacist.||
0924|103|P|   Before having surgery, tell your doctor or dentist about all||
0924|104|P|the products you use (including prescription drugs,||
0924|105|P|nonprescription drugs, and herbal products).||
0924|106|P|   Tell your doctor if you are pregnant or plan to become||
0924|107|P|pregnant. You should not become pregnant while using aliskiren.||
0924|108|P|Aliskiren may harm an unborn baby. If you become pregnant, talk||
0924|109|P|to your doctor right away about the risks and benefits of this||
0924|110|P|medication. See also Warning section.||
0924|111|P|   It is unknown if this drug passes into breast milk. Consult||
0924|112|P|your doctor before breastfeeding.||
0924|113|B|||
0924|114|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
0924|115|I|   Drug interactions may change how your medications work or||
0924|116|I|increase your risk for serious side effects. This document does||
0924|117|I|not contain all possible drug interactions. Keep a list of all||
0924|118|I|the products you use (including prescription/nonprescription||
0924|119|I|drugs and herbal products) and share it with your doctor and||
0924|120|I|pharmacist. Do not start, stop, or change the dosage of any||
0924|121|I|medicines without your doctor's approval.||
0924|122|I|   Some products that may interact with this drug include: drugs||
0924|123|I|that may increase the level of potassium in the blood (including||
0924|124|I|sparsentan, ACE inhibitors such as benazepril/lisinopril, ARBs||
0924|125|I|such as candesartan/losartan, birth control pills containing||
0924|126|I|drospirenone).||
0924|127|I|   Other medications can affect the removal of aliskiren from||
0924|128|I|your body, which may affect how aliskiren works. Examples include||
0924|129|I|itraconazole, cyclosporine, quinidine, among others.||
0924|130|I|   Some products have ingredients that could raise your blood||
0924|131|I|pressure. Tell your pharmacist what products you are using, and||
0924|132|I|ask how to use them safely (especially cough-and-cold products,||
0924|133|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0924|134|B|||
0924|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0924|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0924|137|O|poison control center right away. US residents can call||
0924|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0924|139|O|Symptoms of overdose may include: severe dizziness, fainting.||
0924|140|B|||
0924|141|N|NOTES:  Do not share this medication with others.||
0924|142|N|   Lifestyle changes that may help this medication work better||
0924|143|N|include exercising, stopping smoking, and eating a||
0924|144|N|low-cholesterol/low-fat diet. Consult your doctor for more||
0924|145|N|details.||
0924|146|N|   Lab and/or medical tests (such as kidney function, potassium||
0924|147|N|levels) should be done while you are taking this medication. Keep||
0924|148|N|all medical and lab appointments. Consult your doctor for more||
0924|149|N|details.||
0924|150|N|   Have your blood pressure checked regularly while taking this||
0924|151|N|medication. Learn how to monitor your own blood pressure at home,||
0924|152|N|and share the results with your doctor.||
0924|153|B|||
0924|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0924|155|D|remember. If it is near the time of the next dose, skip the||
0924|156|D|missed dose. Take your next dose at the regular time. Do not||
0924|157|D|double the dose to catch up.||
0924|158|B|||
0924|159|R|STORAGE:  Store in the original container at room temperature||
0924|160|R|away from light and moisture. Do not store in the bathroom. Keep||
0924|161|R|the drying agent (desiccant) in the container. Tightly close the||
0924|162|R|container when not in use. Keep all medications away from||
0924|163|R|children and pets.||
0924|164|R|   Do not flush medications down the toilet or pour them into a||
0924|165|R|drain unless instructed to do so. Properly discard this product||
0924|166|R|when it is expired or no longer needed. Consult your pharmacist||
0924|167|R|or local waste disposal company.||
0924|168|B|||
0924|169|A|Information last revised July 2024.||
0924|170|A|Copyright(c) 2025 First Databank, Inc.||
0924|171|B|||
0926|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0926|002|Z|does NOT have all possible information about this product. This||
0926|003|Z|information does not assure that this product is safe, effective,||
0926|004|Z|or appropriate for you. This information is not individual||
0926|005|Z|medical advice and does not substitute for the advice of your||
0926|006|Z|health care professional. Always ask your health care||
0926|007|Z|professional for complete information about this product and your||
0926|008|Z|specific health needs.||
0926|009|B|||
0926|010|T|CLOFARABINE - INJECTION||
0926|011|F|(kloe-FAR-a-been)||
0926|012|B|||
0926|013|C|COMMON BRAND NAME(S): Clolar||
0926|014|B|||
0926|015|U|USES:  Clofarabine is used to treat a certain type of cancer||
0926|016|U|(acute lymphoblastic leukemia-ALL). It works by slowing or||
0926|017|U|stopping the growth of cancer cells.||
0926|018|B|||
0926|019|H|HOW TO USE:  This medication is given by injection into a vein by||
0926|020|H|a health care professional. It is given over 2 hours as directed||
0926|021|H|by your doctor, usually once a day for 5 days in a row. A 5-day||
0926|022|H|course of this medication is called a cycle. This cycle is||
0926|023|H|repeated every 2 to 6 weeks depending on your response. The||
0926|024|H|dosage is based on your medical condition, body size, and||
0926|025|H|response to treatment.||
0926|026|H|   Drink plenty of fluids to prevent serious problems due to||
0926|027|H|dehydration.||
0926|028|H|   Avoid getting the medication on the skin or in the eyes,||
0926|029|H|mouth, or nose. If you do get the medication in those areas,||
0926|030|H|flush with plenty of water and tell your doctor right away.||
0926|031|B|||
0926|032|S|SIDE EFFECTS:  Pain at the injection site, tiredness, flushing,||
0926|033|S|headache, lightheadedness, drowsiness, back pain, diarrhea,||
0926|034|S|nausea, vomiting, and loss of appetite may occur. Nausea and||
0926|035|S|vomiting can be severe. In some cases, your doctor may prescribe||
0926|036|S|medication to prevent or relieve nausea and vomiting. Eating||
0926|037|S|several small meals, not eating before treatment, or limiting||
0926|038|S|activity may help lessen some of these effects. If these effects||
0926|039|S|last or get worse, tell your doctor or pharmacist promptly.||
0926|040|S|   People using this medication may have serious side effects.||
0926|041|S|However, you have been prescribed this drug because your doctor||
0926|042|S|has judged that the benefit to you is greater than the risk of||
0926|043|S|side effects. Careful monitoring by your doctor may decrease your||
0926|044|S|risk.||
0926|045|S|   Treatment with clofarabine may sometimes cause your hands/feet||
0926|046|S|to develop a skin reaction called hand-foot syndrome||
0926|047|S|(palmar-plantar erythrodysesthesia). You can prevent or reduce||
0926|048|S|these problems by protecting your hands and feet from a great||
0926|049|S|deal of heat or pressure. Avoid unnecessary exposure to heat||
0926|050|S|(such as hot dishwater, long hot baths). Avoid pressure on||
0926|051|S|elbows, knees, and soles of feet (such as leaning on elbows,||
0926|052|S|kneeling, taking long walks). Wear loose clothing. Depending on||
0926|053|S|how severe your hand-foot syndrome is, your doctor may prescribe||
0926|054|S|a medication to reduce the symptoms or decrease/delay your next||
0926|055|S|dose of clofarabine. If you experience pain/swelling/redness,||
0926|056|S|blisters, or numbness of the hands/feet that affects your usual||
0926|057|S|activities, tell your doctor right away.||
0926|058|S|   Tell your doctor right away if you have any serious side||
0926|059|S|effects, including: easy bleeding/bruising, muscle/joint pain,||
0926|060|S|swelling feet/ankles, mental/mood changes (such as anxiety,||
0926|061|S|depression), dark urine, yellowing skin/eyes, fast/difficult||
0926|062|S|breathing, fast heartbeat.||
0926|063|S|   This medication can lower the body's ability to fight an||
0926|064|S|infection. Tell your doctor right away if you develop any signs||
0926|065|S|of an infection (such as sore throat that doesn't go away, fever,||
0926|066|S|chills).||
0926|067|S|   This medication may rarely cause a serious bowel infection||
0926|068|S|(enterocolitis). This infection is more likely to occur within 30||
0926|069|S|days of treatment and when clofarabine is used with other||
0926|070|S|medications to treat cancer. Tell your doctor right away if you||
0926|071|S|develop: diarrhea that doesn't stop, abdominal or stomach||
0926|072|S|pain/cramping, mucus in your stool.||
0926|073|S|   Clofarabine sometimes causes side effects due to the rapid||
0926|074|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
0926|075|S|risk, your doctor may add a medication and tell you to drink||
0926|076|S|plenty of fluids. Tell your doctor right away if you have||
0926|077|S|symptoms such as: low back/side pain (flank pain), signs of||
0926|078|S|kidney problems (such as painful urination, pink/bloody urine,||
0926|079|S|change in the amount of urine), muscle spasms/weakness.||
0926|080|S|   This drug may rarely cause serious (rarely fatal) bleeding in||
0926|081|S|the brain or lungs, or bleeding from the stomach or intestines.||
0926|082|S|If you notice any of the following unlikely but serious side||
0926|083|S|effects, get medical help right away: nausea that doesn't stop,||
0926|084|S|dizziness/fainting, sudden vision changes, seizures, confusion,||
0926|085|S|trouble breathing, black/bloody stools, vomit that contains blood||
0926|086|S|or looks like coffee grounds.||
0926|087|S|   A very serious allergic reaction to this drug is rare.||
0926|088|S|However, get medical help right away if you notice any symptoms||
0926|089|S|of a serious allergic reaction, including: rash, itching/swelling||
0926|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0926|091|S|breathing.||
0926|092|S|   This is not a complete list of possible side effects. If you||
0926|093|S|notice other effects not listed above, contact your doctor or||
0926|094|S|pharmacist.||
0926|095|S|   In the US -||
0926|096|S|   Call your doctor for medical advice about side effects. You||
0926|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0926|098|S|www.fda.gov/medwatch.||
0926|099|S|   In Canada - Call your doctor for medical advice about side||
0926|100|S|effects. You may report side effects to Health Canada at||
0926|101|S|1-866-234-2345.||
0926|102|B|||
0926|103|P|PRECAUTIONS:  Before using clofarabine, tell your doctor or||
0926|104|P|pharmacist if you are allergic to it; or if you have any other||
0926|105|P|allergies. This product may contain inactive ingredients, which||
0926|106|P|can cause allergic reactions or other problems. Talk to your||
0926|107|P|pharmacist for more details.||
0926|108|P|   Before using this medication, tell your doctor or pharmacist||
0926|109|P|your medical history, especially of: blood/bleeding problems,||
0926|110|P|kidney disease, liver disease, recent/current infections.||
0926|111|P|   Clofarabine can make you more likely to get infections or may||
0926|112|P|make current infections worse. Stay away from anyone who has an||
0926|113|P|infection that may easily spread (such as chickenpox, COVID-19,||
0926|114|P|measles, flu). Talk to your doctor if you have been exposed to an||
0926|115|P|infection or for more details.||
0926|116|P|   Tell your health care professional that you are using||
0926|117|P|clofarabine before having any immunizations/vaccinations. Avoid||
0926|118|P|contact with people who have recently received live vaccines||
0926|119|P|(such as flu vaccine inhaled through the nose).||
0926|120|P|   To lower your risk of getting cut, bruised, or injured, use||
0926|121|P|caution with sharp objects like razors and nail cutters, and||
0926|122|P|avoid activities such as contact sports.||
0926|123|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0926|124|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0926|125|P|machinery, or do anything that needs alertness until you can do||
0926|126|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0926|127|P|are using marijuana (cannabis).||
0926|128|P|   Before having surgery, tell your doctor or dentist about all||
0926|129|P|the products you use (including prescription drugs,||
0926|130|P|nonprescription drugs, and herbal products).||
0926|131|P|   Tell your doctor if you are pregnant or plan to become||
0926|132|P|pregnant. You should not become pregnant while using clofarabine.||
0926|133|P|Clofarabine may harm an unborn baby. Your doctor should order a||
0926|134|P|pregnancy test before you start this medication. Women using this||
0926|135|P|medication should ask about reliable forms of birth control||
0926|136|P|during treatment and for 6 months after the last dose. Men using||
0926|137|P|this medication should ask about reliable forms of birth control||
0926|138|P|during treatment and for 3 months after the last dose. If you or||
0926|139|P|your partner becomes pregnant, talk to your doctor right away||
0926|140|P|about the risks and benefits of this medication.||
0926|141|P|   It is unknown if this drug passes into breast milk. Because of||
0926|142|P|the possible risk to the infant, breastfeeding is not recommended||
0926|143|P|while using this drug and for at least 2 weeks after the last||
0926|144|P|dose. Consult your doctor before breastfeeding.||
0926|145|B|||
0926|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0926|147|I|medications work or increase your risk for serious side effects.||
0926|148|I|This document does not contain all possible drug interactions.||
0926|149|I|Keep a list of all the products you use (including||
0926|150|I|prescription/nonprescription drugs and herbal products) and share||
0926|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
0926|152|I|the dosage of any medicines without your doctor's approval.||
0926|153|B|||
0926|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0926|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0926|156|O|poison control center right away. US residents can call||
0926|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0926|158|B|||
0926|159|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0926|160|N|kidney/liver function, bilirubin, blood pressure, lung function)||
0926|161|N|should be done while you are using this medication. Keep all||
0926|162|N|medical and lab appointments.||
0926|163|B|||
0926|164|D|MISSED DOSE:  It is important to get each dose of this medication||
0926|165|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0926|166|D|right away for a new dosing schedule.||
0926|167|B|||
0926|168|R|STORAGE:  Not applicable. This medication is given in a clinic||
0926|169|R|and will not be stored at home.||
0926|170|B|||
0926|171|M|MEDICAL ALERT:  Your condition can cause complications in a||
0926|172|M|medical emergency. For information about enrolling in MedicAlert,||
0926|173|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0926|174|B|||
0926|175|A|Information last revised April 2025.||
0926|176|A|Copyright(c) 2025 First Databank, Inc.||
0926|177|B|||
0927|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0927|002|Z|does NOT have all possible information about this product. This||
0927|003|Z|information does not assure that this product is safe, effective,||
0927|004|Z|or appropriate for you. This information is not individual||
0927|005|Z|medical advice and does not substitute for the advice of your||
0927|006|Z|health care professional. Always ask your health care||
0927|007|Z|professional for complete information about this product and your||
0927|008|Z|specific health needs.||
0927|009|B|||
0927|010|T|LAPATINIB - ORAL||
0927|011|F|(la-PA-ti-nib)||
0927|012|B|||
0927|013|C|COMMON BRAND NAME(S): Tykerb||
0927|014|B|||
0927|015|W|WARNING:  Rarely, people taking lapatinib have developed serious||
0927|016|W|(possibly fatal) liver problems. Your doctor will perform liver||
0927|017|W|function tests before and during treatment to monitor for this||
0927|018|W|side effect. Keep all medical/lab appointments. Tell your doctor||
0927|019|W|right away if you develop symptoms of liver disease such as||
0927|020|W|nausea that doesn't stop, stomach/abdominal pain, dark urine, or||
0927|021|W|yellowing eyes/skin. Do not restart this medication if you have||
0927|022|W|previously stopped taking it due to liver problems.||
0927|023|B|||
0927|024|U|USES:  Lapatinib is used to treat breast cancer. It works by||
0927|025|U|slowing or stopping the growth of cancer cells.||
0927|026|B|||
0927|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0927|028|H|from your pharmacist before you start using lapatinib and each||
0927|029|H|time you get a refill. If you have any questions, ask your doctor||
0927|030|H|or pharmacist.||
0927|031|H|   Take this medication by mouth 1 hour before or 1 hour after a||
0927|032|H|meal as directed by your doctor, usually once daily. It is||
0927|033|H|important that you do not take this medication more than once||
0927|034|H|daily.||
0927|035|H|   The dosage is based on your medical condition, response to||
0927|036|H|treatment, and other medications you may be taking. Be sure to||
0927|037|H|tell your doctor and pharmacist about all the products you use||
0927|038|H|(including prescription drugs, nonprescription drugs, and herbal||
0927|039|H|products).||
0927|040|H|   Do not increase your dose or take this medication more often||
0927|041|H|than prescribed. Your condition will not improve any faster, and||
0927|042|H|the risk of serious side effects may be increased.||
0927|043|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0927|044|H|using this medication unless your doctor or pharmacist says you||
0927|045|H|may do so safely. Grapefruit can increase the chance of side||
0927|046|H|effects with this medicine. Ask your doctor or pharmacist for||
0927|047|H|more details.||
0927|048|H|   Since this drug can be absorbed through the skin and lungs,||
0927|049|H|women who are pregnant or who may become pregnant should not||
0927|050|H|handle this medication or breathe the dust from the tablets.||
0927|051|H|   Follow your doctor's instructions on how to correctly take||
0927|052|H|capecitabine or letrozole with lapatinib.||
0927|053|B|||
0927|054|S|SIDE EFFECTS:  See also Warning section.||
0927|055|S|   Nausea, vomiting, upset stomach, mouth sores, mild rash, dry||
0927|056|S|skin, and trouble sleeping may occur. If any of these effects||
0927|057|S|last or get worse, tell your doctor or pharmacist promptly.||
0927|058|S|   Diarrhea is a common side effect and may become severe. Tell||
0927|059|S|your doctor right away if diarrhea occurs or if you have signs of||
0927|060|S|dehydration such as dizziness or decreased urination. Your doctor||
0927|061|S|should prescribe additional medication to help control your||
0927|062|S|symptoms. If your diarrhea becomes severe, your doctor may need||
0927|063|S|to stop or delay your lapatinib treatment.||
0927|064|S|   Treatment with this drug may sometimes cause your hands/feet||
0927|065|S|to develop a skin reaction called hand-foot syndrome||
0927|066|S|(palmar-plantar erythrodysesthesia). Tell your doctor right away||
0927|067|S|if you experience swelling, pain, redness, peeling, blisters, or||
0927|068|S|tingling/burning of the hands/feet. The symptoms can be made||
0927|069|S|worse by heat/pressure on your hands/feet. Avoid prolonged sun||
0927|070|S|exposure, tanning booths, and sunlamps, as well as unnecessary||
0927|071|S|exposure to heat (such as hot dishwater, long hot baths). Use a||
0927|072|S|sunscreen and wear protective clothing when outdoors. Avoid||
0927|073|S|pressure on elbows, knees, and soles of feet (such as leaning on||
0927|074|S|elbows, kneeling, taking long walks). Wear loose clothing and||
0927|075|S|comfortable shoes. Depending on how severe your hand-foot||
0927|076|S|syndrome is, your doctor may give you an additional medication to||
0927|077|S|reduce the symptoms, or stop or delay your lapatinib treatment.||
0927|078|S|   Remember that this medication has been prescribed because your||
0927|079|S|doctor has judged that the benefit to you is greater than the||
0927|080|S|risk of side effects. Many people using this medication do not||
0927|081|S|have serious side effects.||
0927|082|S|   Tell your doctor right away if you have any serious side||
0927|083|S|effects, including: unusual tiredness, shortness of breath,||
0927|084|S|swelling ankles/feet.||
0927|085|S|   Get medical help right away if you have any very serious side||
0927|086|S|effects, including: fast/pounding/irregular heartbeat, dizziness,||
0927|087|S|fainting.||
0927|088|S|   A very serious allergic reaction to this drug is rare.||
0927|089|S|However, get medical help right away if you notice any symptoms||
0927|090|S|of a serious allergic reaction, including: rash, itching/swelling||
0927|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0927|092|S|breathing.||
0927|093|S|   This is not a complete list of possible side effects. If you||
0927|094|S|notice other effects not listed above, contact your doctor or||
0927|095|S|pharmacist.||
0927|096|S|   In the US -||
0927|097|S|   Call your doctor for medical advice about side effects. You||
0927|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0927|099|S|www.fda.gov/medwatch.||
0927|100|S|   In Canada - Call your doctor for medical advice about side||
0927|101|S|effects. You may report side effects to Health Canada at||
0927|102|S|1-866-234-2345.||
0927|103|B|||
0927|104|P|PRECAUTIONS:  Before taking lapatinib, tell your doctor or||
0927|105|P|pharmacist if you are allergic to it; or if you have any other||
0927|106|P|allergies. This product may contain inactive ingredients, which||
0927|107|P|can cause allergic reactions or other problems. Talk to your||
0927|108|P|pharmacist for more details.||
0927|109|P|   Before using this medication, tell your doctor or pharmacist||
0927|110|P|your medical history, especially of: heart disease (such as||
0927|111|P|irregular heartbeat), liver disease.||
0927|112|P|   Lapatinib may cause a condition that affects the heart rhythm||
0927|113|P|(QT prolongation). QT prolongation can rarely cause serious||
0927|114|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0927|115|P|as severe dizziness, fainting) that need medical attention right||
0927|116|P|away.||
0927|117|P|   The risk of QT prolongation may be increased if you have||
0927|118|P|certain medical conditions or are taking other drugs that may||
0927|119|P|cause QT prolongation. Before using lapatinib, tell your doctor||
0927|120|P|or pharmacist of all the drugs you take and if you have any of||
0927|121|P|the following conditions: certain heart problems (heart failure,||
0927|122|P|slow heartbeat, QT prolongation in the EKG), family history of||
0927|123|P|certain heart problems (QT prolongation in the EKG, sudden||
0927|124|P|cardiac death).||
0927|125|P|   Low levels of potassium or magnesium in the blood may also||
0927|126|P|increase your risk of QT prolongation. This risk may increase if||
0927|127|P|you use certain drugs (such as diuretics/"water pills") or if you||
0927|128|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0927|129|P|Talk to your doctor about using lapatinib safely.||
0927|130|P|   Older adults may be more sensitive to the side effects of this||
0927|131|P|drug, especially QT prolongation (see above).||
0927|132|P|   Tell your doctor if you are pregnant or plan to become||
0927|133|P|pregnant. You should not become pregnant while using lapatinib.||
0927|134|P|Lapatinib may harm an unborn baby. Men and women using this||
0927|135|P|medication should ask about reliable forms of birth control||
0927|136|P|during treatment and for 1 week after the last dose. If you or||
0927|137|P|your partner becomes pregnant, talk to your doctor right away||
0927|138|P|about the risks and benefits of this medication.||
0927|139|P|   It is unknown if this medication passes into breast milk.||
0927|140|P|Because of the possible risk to the infant, breastfeeding is not||
0927|141|P|recommended while using this medication and for 1 week after the||
0927|142|P|last dose. Consult your doctor before breastfeeding.||
0927|143|B|||
0927|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0927|145|I|medications work or increase your risk for serious side effects.||
0927|146|I|This document does not contain all possible drug interactions.||
0927|147|I|Keep a list of all the products you use (including||
0927|148|I|prescription/nonprescription drugs and herbal products) and share||
0927|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
0927|150|I|the dosage of any medicines without your doctor's approval.||
0927|151|I|   This medication can slow down the removal of other medications||
0927|152|I|from your body, which may affect how they work. Examples of||
0927|153|I|affected drugs include certain "statin" cholesterol medications||
0927|154|I|(simvastatin, lovastatin, atorvastatin), digoxin, irinotecan,||
0927|155|I|tacrolimus, trazodone, among others.||
0927|156|I|   Other medications can affect the removal of lapatinib from||
0927|157|I|your body, which may affect how lapatinib works. Examples include||
0927|158|I|cimetidine, dexamethasone, ritonavir, St. John's wort, azole||
0927|159|I|antifungals (such as itraconazole, ketoconazole), macrolide||
0927|160|I|antibiotics (such as erythromycin, clarithromycin), rifamycins||
0927|161|I|(such as rifabutin), certain anti-seizure medicines (such as||
0927|162|I|phenytoin), among others.||
0927|163|I|   Many drugs besides lapatinib may affect the heart rhythm (QT||
0927|164|I|prolongation), including dofetilide, pimozide, procainamide,||
0927|165|I|amiodarone, quinidine, sotalol, macrolide antibiotics (such as||
0927|166|I|erythromycin), among others. Before using lapatinib, report all||
0927|167|I|medications you are currently using to your doctor or pharmacist.||
0927|168|B|||
0927|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0927|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0927|171|O|poison control center right away. US residents can call||
0927|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0927|173|O|Symptoms of overdose may include: severe diarrhea/vomiting.||
0927|174|B|||
0927|175|N|NOTES:  Do not share this medication with others.||
0927|176|N|   Lab and/or medical tests (such as EKG, blood mineral levels,||
0927|177|N|heart/liver function) should be done while you are taking this||
0927|178|N|medication. Keep all medical and lab appointments. Consult your||
0927|179|N|doctor for more details.||
0927|180|B|||
0927|181|D|MISSED DOSE:  It is important to take each dose of this||
0927|182|D|medication as scheduled. If you miss a dose, take it as soon as||
0927|183|D|you remember. If it is near the time of the next dose, skip the||
0927|184|D|missed dose. Take your next dose at the regular time. Do not||
0927|185|D|double the dose to catch up.||
0927|186|B|||
0927|187|R|STORAGE:  Store at room temperature away from light and moisture.||
0927|188|R|Do not store in the bathroom. Keep all medications away from||
0927|189|R|children and pets.||
0927|190|R|   Do not flush medications down the toilet or pour them into a||
0927|191|R|drain unless instructed to do so. Properly discard this product||
0927|192|R|when it is expired or no longer needed. Consult your pharmacist||
0927|193|R|or local waste disposal company.||
0927|194|B|||
0927|195|A|Information last revised January 2025.||
0927|196|A|Copyright(c) 2025 First Databank, Inc.||
0927|197|B|||
0928|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0928|002|Z|does NOT have all possible information about this product. This||
0928|003|Z|information does not assure that this product is safe, effective,||
0928|004|Z|or appropriate for you. This information is not individual||
0928|005|Z|medical advice and does not substitute for the advice of your||
0928|006|Z|health care professional. Always ask your health care||
0928|007|Z|professional for complete information about this product and your||
0928|008|Z|specific health needs.||
0928|009|B|||
0928|010|T|ARFORMOTEROL SOLUTION - INHALATION||
0928|011|F|(AR-for-MOE-ter-ol)||
0928|012|B|||
0928|013|C|COMMON BRAND NAME(S): Brovana||
0928|014|B|||
0928|015|U|USES:  Arformoterol is used as a long-term (maintenance)||
0928|016|U|treatment to prevent and decrease wheezing and shortness of||
0928|017|U|breath caused by breathing problems (such as chronic obstructive||
0928|018|U|pulmonary disease, including chronic bronchitis and emphysema).||
0928|019|U|Arformoterol belongs to the class of drugs known as long-acting||
0928|020|U|beta agonists (LABAs). Arformoterol is also known as a||
0928|021|U|bronchodilator. It works by relaxing the muscles around the||
0928|022|U|airways so that they open up and you can breathe more easily.||
0928|023|U|Controlling symptoms of breathing problems can decrease time lost||
0928|024|U|from work or school.||
0928|025|U|   This medication does not work right away and should not be||
0928|026|U|used for sudden attacks of breathing trouble. Your doctor must||
0928|027|U|prescribe a quick-relief medicine/inhaler (such as albuterol,||
0928|028|U|also known as salbutamol) for sudden shortness of breath while||
0928|029|U|you are using arformoterol. You should always have a quick-relief||
0928|030|U|inhaler with you.||
0928|031|U|   Arformoterol is not approved to treat asthma. People with||
0928|032|U|asthma using long-acting inhaled beta agonists (such as||
0928|033|U|arformoterol) without also using an inhaled corticosteroid may||
0928|034|U|have an increased risk of serious (sometimes fatal) breathing||
0928|035|U|problems.||
0928|036|B|||
0928|037|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0928|038|H|your pharmacist before you start using this medication and each||
0928|039|H|time you get a refill. This medication is used with a special||
0928|040|H|machine called a nebulizer that changes the solution to a fine||
0928|041|H|mist that you inhale. Learn how to prepare the solution and use||
0928|042|H|the nebulizer properly. If a child is using this medication, a||
0928|043|H|parent or other responsible adult may need to help the child use||
0928|044|H|the nebulizer properly. If you have any questions, ask your||
0928|045|H|doctor, pharmacist, or respiratory therapist.||
0928|046|H|   This product should be clear and colorless. Before using,||
0928|047|H|check this product for particles or discoloration. If either is||
0928|048|H|present, do not use the liquid.||
0928|049|H|   Using the nebulizer, inhale this medication into your lungs as||
0928|050|H|directed by your doctor, usually 2 times a day (once in the||
0928|051|H|morning and once in the evening). The 2 doses should be about 12||
0928|052|H|hours apart. Each treatment usually takes about 5 to 10 minutes.||
0928|053|H|Use this medication only through a nebulizer. Do not swallow or||
0928|054|H|inject the solution. Do not mix with other medicines in the||
0928|055|H|nebulizer. To prevent infections, clean the nebulizer and||
0928|056|H|mouthpiece/face mask according to the manufacturer's directions.||
0928|057|H|   Use this medication regularly to get the most benefit from it.||
0928|058|H|To help you remember, use it at the same times each day.||
0928|059|H|   The dosage is based on your medical condition, age, and||
0928|060|H|response to treatment. Do not use more of this medication or use||
0928|061|H|it more often than prescribed since this may cause serious side||
0928|062|H|effects. Do not use more than 30 micrograms of arformoterol a||
0928|063|H|day.||
0928|064|H|   If you have been using a quick-relief inhaler (albuterol,||
0928|065|H|salbutamol) on a regular daily schedule (such as 4 times daily),||
0928|066|H|your doctor will direct you to stop this schedule and only use||
0928|067|H|the quick-relief inhaler as needed for sudden shortness of||
0928|068|H|breath. Consult your doctor for details.||
0928|069|H|   Learn which of your inhalers/medications you should use every||
0928|070|H|day and which you should use if your breathing suddenly worsens||
0928|071|H|(quick-relief drugs). Ask your doctor ahead of time what you||
0928|072|H|should do if you have new or worsening cough or shortness of||
0928|073|H|breath, wheezing, increased sputum, worsening peak flow meter||
0928|074|H|readings, waking up at night with trouble breathing, if you use||
0928|075|H|your quick-relief inhaler more often (more than 2 days a week),||
0928|076|H|or if your quick-relief inhaler does not seem to be working well.||
0928|077|H|Learn when you can treat sudden breathing problems by yourself||
0928|078|H|and when you must get medical help right away.||
0928|079|H|   Tell your doctor if your symptoms do not get better or if they||
0928|080|H|get worse.||
0928|081|B|||
0928|082|S|SIDE EFFECTS:  Nervousness, dizziness, shaking (tremor),||
0928|083|S|headache, nausea, dry mouth, or trouble sleeping may occur. If||
0928|084|S|any of these effects last or get worse, tell your doctor or||
0928|085|S|pharmacist promptly.||
0928|086|S|   Remember that this medication has been prescribed because your||
0928|087|S|doctor has judged that the benefit to you is greater than the||
0928|088|S|risk of side effects. Many people using this medication do not||
0928|089|S|have serious side effects.||
0928|090|S|   This medication may raise your blood pressure. Check your||
0928|091|S|blood pressure regularly and tell your doctor if the results are||
0928|092|S|high.||
0928|093|S|   Tell your doctor right away if you have any serious side||
0928|094|S|effects, including: muscle cramps/weakness, increased||
0928|095|S|thirst/urination.||
0928|096|S|   Get medical help right away if you have any very serious side||
0928|097|S|effects, including: chest pain, rapid breathing, confusion,||
0928|098|S|fast/irregular heartbeat, severe dizziness, fainting.||
0928|099|S|   Rarely, this medication has caused severe (possibly fatal),||
0928|100|S|sudden worsening of breathing problems (paradoxical||
0928|101|S|bronchospasm). If you have trouble breathing or sudden wheezing,||
0928|102|S|use your quick-relief inhaler and get medical help right away.||
0928|103|S|   A very serious allergic reaction to this drug is rare.||
0928|104|S|However, get medical help right away if you notice any symptoms||
0928|105|S|of a serious allergic reaction, including: rash, itching/swelling||
0928|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0928|107|S|breathing.||
0928|108|S|   This is not a complete list of possible side effects. If you||
0928|109|S|notice other effects not listed above, contact your doctor or||
0928|110|S|pharmacist.||
0928|111|S|   In the US -||
0928|112|S|   Call your doctor for medical advice about side effects. You||
0928|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0928|114|S|www.fda.gov/medwatch.||
0928|115|S|   In Canada - Call your doctor for medical advice about side||
0928|116|S|effects. You may report side effects to Health Canada at||
0928|117|S|1-866-234-2345.||
0928|118|B|||
0928|119|P|PRECAUTIONS:  Before using arformoterol, tell your doctor or||
0928|120|P|pharmacist if you are allergic to it; or to formoterol; or if you||
0928|121|P|have any other allergies. This product may contain inactive||
0928|122|P|ingredients, which can cause allergic reactions or other||
0928|123|P|problems. Talk to your pharmacist for more details.||
0928|124|P|   Before using this medication, tell your doctor or pharmacist||
0928|125|P|your medical history, especially of: diabetes, heart problems||
0928|126|P|(such as irregular heartbeat, angina, previous heart attack),||
0928|127|P|high blood pressure, liver problems, seizures, overactive thyroid||
0928|128|P|(hyperthyroidism), swelling of an artery (aneurysm), a certain||
0928|129|P|adrenal gland tumor (pheochromocytoma).||
0928|130|P|   Arformoterol may cause a condition that affects the heart||
0928|131|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0928|132|P|serious (rarely fatal) fast/irregular heartbeat and other||
0928|133|P|symptoms (such as severe dizziness, fainting) that need medical||
0928|134|P|attention right away.||
0928|135|P|   The risk of QT prolongation may be increased if you have||
0928|136|P|certain medical conditions or are taking other drugs that may||
0928|137|P|cause QT prolongation. Before using arformoterol, tell your||
0928|138|P|doctor or pharmacist of all the drugs you take and if you have||
0928|139|P|any of the following conditions: certain heart problems (heart||
0928|140|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0928|141|P|history of certain heart problems (QT prolongation in the EKG,||
0928|142|P|sudden cardiac death).||
0928|143|P|   Low levels of potassium or magnesium in the blood may also||
0928|144|P|increase your risk of QT prolongation. This risk may increase if||
0928|145|P|you use certain drugs (such as diuretics/"water pills") or if you||
0928|146|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0928|147|P|Talk to your doctor about using arformoterol safely.||
0928|148|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0928|149|P|can make you more dizzy. Do not drive, use machinery, or do||
0928|150|P|anything that needs alertness until you can do it safely. Limit||
0928|151|P|alcoholic beverages. Talk to your doctor if you are using||
0928|152|P|marijuana (cannabis).||
0928|153|P|   Before having surgery, tell your doctor or dentist about all||
0928|154|P|the products you use (including prescription drugs,||
0928|155|P|nonprescription drugs, and herbal products).||
0928|156|P|   Older adults may be more sensitive to the side effects of this||
0928|157|P|drug, especially QT prolongation (see above).||
0928|158|P|   During pregnancy, this medication should be used only when||
0928|159|P|clearly needed. Discuss the risks and benefits with your doctor.||
0928|160|P|   It is unknown if this drug passes into breast milk. Consult||
0928|161|P|your doctor before breastfeeding.||
0928|162|B|||
0928|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0928|164|I|medications work or increase your risk for serious side effects.||
0928|165|I|This document does not contain all possible drug interactions.||
0928|166|I|Keep a list of all the products you use (including||
0928|167|I|prescription/nonprescription drugs and herbal products) and share||
0928|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
0928|169|I|the dosage of any medicines without your doctor's approval.||
0928|170|I|   Do not use other LABA drugs (such as formoterol, salmeterol)||
0928|171|I|while using this medication.||
0928|172|B|||
0928|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0928|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0928|175|O|poison control center right away. US residents can call||
0928|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0928|177|O|Symptoms of overdose may include: chest pain, fast/irregular||
0928|178|O|heartbeat, severe dizziness, fainting.||
0928|179|B|||
0928|180|N|NOTES:  Do not share this medication with others.||
0928|181|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
0928|182|N|EKG) may be done while you are using this medication. Keep all||
0928|183|N|medical and lab appointments. Consult your doctor for more||
0928|184|N|details.||
0928|185|N|   Avoid allergens/irritants that can worsen breathing problems,||
0928|186|N|such as smoke, pollen, pet dander, dust, or molds.||
0928|187|N|   Learn to use a peak flow meter, use it daily, and promptly||
0928|188|N|report worsening breathing problems (such as readings in the||
0928|189|N|yellow/red range, increased use of quick-relief inhalers).||
0928|190|N|   Because the flu virus can worsen breathing problems, ask your||
0928|191|N|doctor or pharmacist if you should have a flu shot every year.||
0928|192|B|||
0928|193|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0928|194|D|If it is near the time of the next dose, skip the missed dose.||
0928|195|D|Use your next dose at the regular time. Do not double the dose to||
0928|196|D|catch up.||
0928|197|B|||
0928|198|R|STORAGE:  Store in the refrigerator away from light. Keep the||
0928|199|R|medication in the sealed foil pouch until ready to use. After||
0928|200|R|opening the pouch, store the unused vials back in the pouch.||
0928|201|R|Unopened foil pouches may also be stored at room temperature if||
0928|202|R|needed. If the medication is stored at room temperature, discard||
0928|203|R|after 6 weeks. Keep all medications away from children and pets.||
0928|204|R|   Do not flush medications down the toilet or pour them into a||
0928|205|R|drain unless instructed to do so. Properly discard this product||
0928|206|R|when it is expired or no longer needed. Consult your pharmacist||
0928|207|R|or local waste disposal company.||
0928|208|B|||
0928|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
0928|210|M|medical emergency. For information about enrolling in MedicAlert,||
0928|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0928|212|B|||
0928|213|A|Information last revised November 2024.||
0928|214|A|Copyright(c) 2025 First Databank, Inc.||
0928|215|B|||
0929|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0929|002|Z|does NOT have all possible information about this product. This||
0929|003|Z|information does not assure that this product is safe, effective,||
0929|004|Z|or appropriate for you. This information is not individual||
0929|005|Z|medical advice and does not substitute for the advice of your||
0929|006|Z|health care professional. Always ask your health care||
0929|007|Z|professional for complete information about this product and your||
0929|008|Z|specific health needs.||
0929|009|B|||
0929|010|T|CALCIUM CARBONATE/SIMETHICONE CHEWABLE - ORAL||
0929|011|F|(KAL-see-um KAR-bo-nate/sye-METH-i-kone)||
0929|012|B|||
0929|013|U|USES:  This combination medication is used to treat symptoms||
0929|014|U|caused by too much stomach acid such as heartburn, upset stomach,||
0929|015|U|or indigestion. It is also used to treat symptoms of extra gas||
0929|016|U|such as bloating and feelings of pressure/discomfort in the||
0929|017|U|stomach/gut. Calcium carbonate is an antacid that works by||
0929|018|U|lowering the amount of acid in the stomach. Simethicone works by||
0929|019|U|breaking up gas bubbles in the gut.||
0929|020|U|   Check the ingredients on the label even if you have used the||
0929|021|U|product before. The manufacturer may have changed the||
0929|022|U|ingredients. Also, products with similar names may contain||
0929|023|U|different ingredients meant for different purposes. Taking the||
0929|024|U|wrong product could harm you.||
0929|025|B|||
0929|026|H|HOW TO USE:  Take this product by mouth as directed. Chew the||
0929|027|H|medication well before swallowing. Follow all directions on the||
0929|028|H|product package. Do not take more than the maximum recommended||
0929|029|H|dose stated on the product package. If you have any questions,||
0929|030|H|ask your doctor or pharmacist.||
0929|031|H|   Tell your doctor if your condition lasts or gets worse. Do not||
0929|032|H|take the maximum dose of the medication for more than 2 weeks||
0929|033|H|unless directed by your doctor. If you think you may have a||
0929|034|H|serious medical problem, get medical help right away.||
0929|035|B|||
0929|036|S|SIDE EFFECTS:  Constipation may occur. If this effect lasts or||
0929|037|S|gets worse, tell your doctor or pharmacist promptly.||
0929|038|S|   If your doctor has directed you to use this medication,||
0929|039|S|remember that your doctor has judged that the benefit to you is||
0929|040|S|greater than the risk of side effects. Many people using this||
0929|041|S|medication do not have serious side effects.||
0929|042|S|   Tell your doctor right away if you have any serious side||
0929|043|S|effects, including: loss of appetite, nausea/vomiting, unusual||
0929|044|S|weight loss, bone/muscle pain, mental/mood changes (such as||
0929|045|S|confusion), headache, increased thirst/urination, unusual||
0929|046|S|weakness/tiredness, signs of kidney problems (such as change in||
0929|047|S|the amount of urine).||
0929|048|S|   A very serious allergic reaction to this drug is rare.||
0929|049|S|However, get medical help right away if you notice any symptoms||
0929|050|S|of a serious allergic reaction, including: rash, itching/swelling||
0929|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0929|052|S|breathing.||
0929|053|S|   This is not a complete list of possible side effects. If you||
0929|054|S|notice other effects not listed above, contact your doctor or||
0929|055|S|pharmacist.||
0929|056|S|   In the US -||
0929|057|S|   Call your doctor for medical advice about side effects. You||
0929|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0929|059|S|www.fda.gov/medwatch.||
0929|060|S|   In Canada - Call your doctor for medical advice about side||
0929|061|S|effects. You may report side effects to Health Canada at||
0929|062|S|1-866-234-2345.||
0929|063|B|||
0929|064|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0929|065|P|pharmacist if you are allergic to calcium carbonate or||
0929|066|P|simethicone; or if you have any other allergies. This product may||
0929|067|P|contain inactive ingredients (such as soy), which can cause||
0929|068|P|allergic reactions or other problems. Talk to your pharmacist for||
0929|069|P|more details.||
0929|070|P|   If you have any of the following health problems, consult your||
0929|071|P|doctor or pharmacist before using this product: high calcium||
0929|072|P|levels (hypercalcemia), stomach/intestinal blockage, kidney||
0929|073|P|disease (such as kidney stones), dehydration.||
0929|074|P|   This medicine may contain sugar. If you have diabetes, consult||
0929|075|P|your doctor or pharmacist about using this drug safely.||
0929|076|P|   Before having surgery, tell your doctor or dentist about all||
0929|077|P|the products you use (including prescription drugs,||
0929|078|P|nonprescription drugs, and herbal products).||
0929|079|P|   If you are pregnant, tell your doctor before using this||
0929|080|P|medication.||
0929|081|P|   Calcium carbonate passes into breast milk. It is unknown if||
0929|082|P|simethicone passes into breast milk. Consult your doctor before||
0929|083|P|breastfeeding.||
0929|084|B|||
0929|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0929|086|I|medications work or increase your risk for serious side effects.||
0929|087|I|This document does not contain all possible drug interactions.||
0929|088|I|Keep a list of all the products you use (including||
0929|089|I|prescription/nonprescription drugs and herbal products) and share||
0929|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
0929|091|I|the dosage of any medicines without your doctor's approval.||
0929|092|I|   Antacids can interfere with the absorption of many other||
0929|093|I|drugs. Be sure to check with your pharmacist before taking||
0929|094|I|antacids with any other medication.||
0929|095|I|   Check the labels on all your prescription and||
0929|096|I|nonprescription/herbal products (such as supplements, vitamins)||
0929|097|I|because they may contain calcium. Ask your pharmacist about using||
0929|098|I|those products safely.||
0929|099|B|||
0929|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0929|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0929|102|O|poison control center right away. US residents can call||
0929|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0929|104|O|Symptoms of overdose may include: nausea/vomiting, loss of||
0929|105|O|appetite, mental/mood changes, headache, weakness, dizziness.||
0929|106|B|||
0929|107|N|NOTES:  Keep all medical and lab appointments.||
0929|108|N|   Lifestyle changes such as stress reduction programs, stopping||
0929|109|N|smoking, limiting alcohol, and diet changes (such as avoiding||
0929|110|N|caffeine/certain spices) may help to reduce heartburn and other||
0929|111|N|stomach acid problems. Talk to your doctor or pharmacist about||
0929|112|N|lifestyle changes that might benefit you.||
0929|113|B|||
0929|114|D|MISSED DOSE:  Not applicable.||
0929|115|B|||
0929|116|R|STORAGE:  Store at room temperature away from light and moisture.||
0929|117|R|Do not store in the bathroom. Keep all medications away from||
0929|118|R|children and pets.||
0929|119|R|   Do not flush medications down the toilet or pour them into a||
0929|120|R|drain unless instructed to do so. Properly discard this product||
0929|121|R|when it is expired or no longer needed. Consult your pharmacist||
0929|122|R|or local waste disposal company.||
0929|123|B|||
0929|124|A|Information last revised October 2025.||
0929|125|A|Copyright(c) 2025 First Databank, Inc.||
0929|126|B|||
0930|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0930|002|Z|does NOT have all possible information about this product. This||
0930|003|Z|information does not assure that this product is safe, effective,||
0930|004|Z|or appropriate for you. This information is not individual||
0930|005|Z|medical advice and does not substitute for the advice of your||
0930|006|Z|health care professional. Always ask your health care||
0930|007|Z|professional for complete information about this product and your||
0930|008|Z|specific health needs.||
0930|009|B|||
0930|010|T|BISMUTH SUBCITRATE/METRONIDAZOLE/TETRACYCLINE - ORAL||
0930|011|F|(BIZ-muth sub-SIT-rate/MET-roe-NYE-da-zole/TET-ra-SYE-kleen)||
0930|012|B|||
0930|013|C|COMMON BRAND NAME(S): Pylera||
0930|014|B|||
0930|015|U|USES:  This combination medication is used with an acid blocker||
0930|016|U|(for example, a proton pump inhibitor such as omeprazole). It is||
0930|017|U|used to treat stomach/intestinal ulcers caused by the bacteria H.||
0930|018|U|pylori and to prevent the ulcers from returning.||
0930|019|U|   Each capsule contains 3 medications: bismuth subcitrate,||
0930|020|U|metronidazole, and tetracycline. Bismuth subcitrate is often used||
0930|021|U|to treat upset stomach, but it is used in this combination to||
0930|022|U|help stop the growth of bacteria. Metronidazole and tetracycline||
0930|023|U|are antibiotics used to treat a wide variety of bacterial||
0930|024|U|infections. They work by stopping the growth of bacteria.||
0930|025|U|   This product treats only bacterial infections. It will not||
0930|026|U|work for viral infections (such as common cold, flu). Using any||
0930|027|U|antibiotic when it is not needed can cause it to not work for||
0930|028|U|future infections.||
0930|029|U|   This product is not recommended for use in children.||
0930|030|B|||
0930|031|H|HOW TO USE:  Take this medication by mouth as directed by your||
0930|032|H|doctor, usually 4 times daily (after meals and at bedtime) for 10||
0930|033|H|days. Take each dose (3 capsules) with a full glass of water (8||
0930|034|H|ounces or 240 milliliters) unless your doctor directs you||
0930|035|H|otherwise. Swallow the capsules whole. Do not crush or chew the||
0930|036|H|capsules. Do not lie down for at least 10 minutes after taking||
0930|037|H|this medication.||
0930|038|H|   Follow your doctor's instructions on how to correctly take an||
0930|039|H|acid blocker with this medication.||
0930|040|H|   Take this medication 2 to 3 hours before or after taking any||
0930|041|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
0930|042|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
0930|043|H|sucralfate, vitamins/minerals, dairy products (such as milk,||
0930|044|H|yogurt), and juice with added calcium. These products bind with||
0930|045|H|tetracycline, preventing your body from fully absorbing the drug.||
0930|046|H|   Take this medication regularly in order to get the most||
0930|047|H|benefit from it. Continue to take this medication and the acid||
0930|048|H|blocker until the full prescribed amount is finished, even if||
0930|049|H|symptoms disappear after a few days. Stopping the medication too||
0930|050|H|early may result in a return of the infection/ulcer.||
0930|051|H|   Tell your doctor if your condition lasts or gets worse.||
0930|052|B|||
0930|053|S|SIDE EFFECTS:  Nausea, diarrhea, upset stomach, abdominal pain,||
0930|054|S|changes in taste, headache, or dizziness may occur. If any of||
0930|055|S|these effects last or get worse, tell your doctor or pharmacist||
0930|056|S|promptly.||
0930|057|S|   Your tongue may turn dark in color while you are taking this||
0930|058|S|medication. This is harmless, and the effect will disappear when||
0930|059|S|you stop the medication.||
0930|060|S|   Remember that this medication has been prescribed because your||
0930|061|S|doctor has judged that the benefit to you is greater than the||
0930|062|S|risk of side effects. Many people using this medication do not||
0930|063|S|have serious side effects.||
0930|064|S|   Tell your doctor right away if you have any serious side||
0930|065|S|effects, including: numbness/tingling of arms/legs, discolored||
0930|066|S|teeth, mental/mood changes (such as confusion, anxiety,||
0930|067|S|irritability, depression), difficult/painful swallowing,||
0930|068|S|heartburn, fast/pounding heartbeat, ringing in the ears,||
0930|069|S|frequent/painful urination, stiff/painful neck, signs of kidney||
0930|070|S|problems (such as change in the amount of urine), easy||
0930|071|S|bruising/bleeding, unusual weakness/tiredness, seizures, chest||
0930|072|S|pain, symptoms of liver disease (such as loss of appetite, severe||
0930|073|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0930|074|S|   This product commonly causes dark stools that are usually not||
0930|075|S|serious. However, you may not be able to tell this effect apart||
0930|076|S|from blood in the stool, which could be a sign of a serious||
0930|077|S|condition. Tell your doctor right away if you have dark stools.||
0930|078|S|   Tetracycline may rarely cause increased pressure around the||
0930|079|S|brain (intracranial hypertension-IH). The risk of this side||
0930|080|S|effect is greater for women of childbearing age who are||
0930|081|S|overweight or who have had IH in the past. If IH develops, it||
0930|082|S|usually goes away after tetracycline is stopped; however, there||
0930|083|S|is a chance of permanent vision loss or blindness. Get medical||
0930|084|S|help right away if you have: headache that is severe or doesn't||
0930|085|S|go away, nausea/vomiting that doesn't stop, vision changes (such||
0930|086|S|as blurred/double vision, decreased vision, sudden blindness).||
0930|087|S|   This medication may rarely cause a severe intestinal condition||
0930|088|S|due to a bacteria called C. difficile. This condition may occur||
0930|089|S|during treatment or weeks to months after treatment has stopped.||
0930|090|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0930|091|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0930|092|S|stool.||
0930|093|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0930|094|S|products because they may make symptoms worse.||
0930|095|S|   This medication may sometimes cause oral thrush or a new yeast||
0930|096|S|infection. Contact your doctor if you notice white patches in||
0930|097|S|your mouth, a change in vaginal discharge, or other new symptoms.||
0930|098|S|   A very serious allergic reaction to this drug is rare.||
0930|099|S|However, get medical help right away if you notice any symptoms||
0930|100|S|of a serious allergic reaction, including: fever, swollen lymph||
0930|101|S|nodes, rash, itching/swelling (especially of the||
0930|102|S|face/tongue/throat), severe dizziness, trouble breathing.||
0930|103|S|   This is not a complete list of possible side effects. If you||
0930|104|S|notice other effects not listed above, contact your doctor or||
0930|105|S|pharmacist.||
0930|106|S|   In the US -||
0930|107|S|   Call your doctor for medical advice about side effects. You||
0930|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0930|109|S|www.fda.gov/medwatch.||
0930|110|S|   In Canada - Call your doctor for medical advice about side||
0930|111|S|effects. You may report side effects to Health Canada at||
0930|112|S|1-866-234-2345.||
0930|113|B|||
0930|114|P|PRECAUTIONS:  See also Side Effects section.||
0930|115|P|   Before taking this product, tell your doctor or pharmacist if||
0930|116|P|you are allergic to bismuth subcitrate, metronidazole, or||
0930|117|P|tetracycline; or to tinidazole; or to other tetracyclines (such||
0930|118|P|as doxycycline); or to other bismuth products (such as bismuth||
0930|119|P|subsalicylate); or if you have any other allergies. This product||
0930|120|P|may contain inactive ingredients, which can cause allergic||
0930|121|P|reactions or other problems. Talk to your pharmacist for more||
0930|122|P|details.||
0930|123|P|   Before using this medication, tell your doctor or pharmacist||
0930|124|P|your medical history, especially of: kidney disease, liver||
0930|125|P|disease, blood disorders, brain/spinal cord disorders (such as||
0930|126|P|seizures), trouble swallowing, esophagus problems (such as hiatal||
0930|127|P|hernia, reflux disease-GERD), a certain rare genetic disorder||
0930|128|P|(Cockayne syndrome).||
0930|129|P|   This product may cause live bacterial vaccines (such as||
0930|130|P|typhoid vaccine) to not work well. Tell your health care||
0930|131|P|professional that you are using this medication before having any||
0930|132|P|immunizations/vaccinations.||
0930|133|P|   Before having surgery, tell your doctor or dentist about all||
0930|134|P|the products you use (including prescription drugs,||
0930|135|P|nonprescription drugs, and herbal products).||
0930|136|P|   Tetracycline may make you more sensitive to the sun. Limit||
0930|137|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0930|138|P|sunscreen and wear protective clothing when outdoors. Tell your||
0930|139|P|doctor right away if you get sunburned or have skin||
0930|140|P|blisters/redness.||
0930|141|P|   Avoid alcoholic beverages and products containing propylene||
0930|142|P|glycol while taking this product and for at least 3 days after||
0930|143|P|finishing this product because severe stomach upset/cramps,||
0930|144|P|nausea, vomiting, headache, and flushing may occur.||
0930|145|P|   This product may make you dizzy. Alcohol or marijuana||
0930|146|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
0930|147|P|or do anything that needs alertness until you can do it safely.||
0930|148|P|Talk to your doctor if you are using marijuana (cannabis).||
0930|149|P|   Children should not take this product because it contains||
0930|150|P|tetracycline. Tetracycline may cause permanent tooth||
0930|151|P|discoloration and other problems in children younger than 8||
0930|152|P|years. Tooth discoloration has also occurred in older children||
0930|153|P|and young adults. Consult the doctor for more information.||
0930|154|P|   This product must not be used during pregnancy. It may harm an||
0930|155|P|unborn baby. Discuss the use of reliable forms of birth control||
0930|156|P|(such as condoms, birth control pills) with your doctor. If you||
0930|157|P|become pregnant or think you may be pregnant, tell your doctor||
0930|158|P|right away.||
0930|159|P|   This product contains drugs that may pass into breast milk.||
0930|160|P|Consult your doctor before breastfeeding.||
0930|161|B|||
0930|162|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
0930|163|I|   Drug interactions may change how your medications work or||
0930|164|I|increase your risk for serious side effects. This document does||
0930|165|I|not contain all possible drug interactions. Keep a list of all||
0930|166|I|the products you use (including prescription/nonprescription||
0930|167|I|drugs and herbal products) and share it with your doctor and||
0930|168|I|pharmacist. Do not start, stop, or change the dosage of any||
0930|169|I|medicines without your doctor's approval.||
0930|170|I|   Some products that may interact with this drug include:||
0930|171|I|alcohol-containing products (such as cough and cold syrups,||
0930|172|I|aftershave), atovaquone, digoxin, lithium, lopinavir/ritonavir||
0930|173|I|solution, products containing propylene glycol, retinoid||
0930|174|I|medications (such as acitretin, isotretinoin, tretinoin),||
0930|175|I|strontium.||
0930|176|I|   Do not take this product if you are also taking disulfiram or||
0930|177|I|if you have taken disulfiram within the last 2 weeks.||
0930|178|I|   This product may interfere with certain lab tests, possibly||
0930|179|I|causing false test results. This product may also interfere with||
0930|180|I|X-ray exams of the stomach/intestines. Make sure lab personnel||
0930|181|I|and all your doctors know you use this drug.||
0930|182|B|||
0930|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0930|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0930|185|O|poison control center right away. US residents can call||
0930|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0930|187|O|Symptoms of overdose may include: seizures.||
0930|188|B|||
0930|189|N|NOTES:  Do not share this medication with others.||
0930|190|N|   Lab and/or medical tests may be done while you are taking this||
0930|191|N|medication. Keep all medical and lab appointments. Consult your||
0930|192|N|doctor for more details.||
0930|193|N|   This medication has been prescribed for your current condition||
0930|194|N|only. Do not use it later for another infection unless your||
0930|195|N|doctor tells you to.||
0930|196|B|||
0930|197|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
0930|198|D|next dose at the regular time. Do not double the dose to catch||
0930|199|D|up. Contact your doctor if you miss more than 4 doses.||
0930|200|B|||
0930|201|R|STORAGE:  Store at room temperature away from light and moisture.||
0930|202|R|Do not store in the bathroom. Keep all medications away from||
0930|203|R|children and pets.||
0930|204|R|   Do not flush medications down the toilet or pour them into a||
0930|205|R|drain unless instructed to do so. Properly discard this product||
0930|206|R|when it is expired or no longer needed. Taking outdated||
0930|207|R|tetracycline can result in serious illness. Consult your||
0930|208|R|pharmacist or local waste disposal company.||
0930|209|B|||
0930|210|A|Information last revised September 2025.||
0930|211|A|Copyright(c) 2025 First Databank, Inc.||
0930|212|B|||
0931|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0931|002|Z|does NOT have all possible information about this product. This||
0931|003|Z|information does not assure that this product is safe, effective,||
0931|004|Z|or appropriate for you. This information is not individual||
0931|005|Z|medical advice and does not substitute for the advice of your||
0931|006|Z|health care professional. Always ask your health care||
0931|007|Z|professional for complete information about this product and your||
0931|008|Z|specific health needs.||
0931|009|B|||
0931|010|T|AZACITIDINE - INJECTION||
0931|011|F|(AY-za-SYE-ti-deen)||
0931|012|B|||
0931|013|C|COMMON BRAND NAME(S): Vidaza||
0931|014|B|||
0931|015|U|USES:  This medication is used to treat certain types of blood||
0931|016|U|cancers in which the bone marrow does not produce enough healthy||
0931|017|U|blood cells. People with these disorders usually have problems||
0931|018|U|such as infections, anemia, and easy bleeding/bruising.||
0931|019|U|Azacitidine works by helping your bone marrow make healthy blood||
0931|020|U|cells. It also kills abnormal blood cells that have grown too||
0931|021|U|fast and do not work properly.||
0931|022|U|   This form of azacitidine should not be used in place of the||
0931|023|U|form taken by mouth.||
0931|024|B|||
0931|025|H|HOW TO USE:  This medication is given by injection under the skin||
0931|026|H|or into a vein by a health care professional. It is injected as||
0931|027|H|directed by your doctor, usually once a day for 7 days in a row.||
0931|028|H|A 7-day course of this medication is called a cycle. This cycle||
0931|029|H|is repeated every 4 weeks depending on your response and blood||
0931|030|H|tests. The dosage is based on your medical condition, body size,||
0931|031|H|lab tests, and response to treatment.||
0931|032|B|||
0931|033|S|SIDE EFFECTS:  Redness/pain/bruising at the injection site,||
0931|034|S|tiredness, diarrhea, dizziness, trouble sleeping, constipation,||
0931|035|S|nausea, vomiting, mouth sores, dry skin, headache, and loss of||
0931|036|S|appetite may occur. Nausea and vomiting can be severe. In some||
0931|037|S|cases, your doctor may prescribe medication to prevent or relieve||
0931|038|S|nausea and vomiting. Eating several small meals, not eating||
0931|039|S|before treatment, or limiting activity may help lessen some of||
0931|040|S|these effects. If these effects last or worsen, tell your doctor||
0931|041|S|or pharmacist promptly.||
0931|042|S|   People using this medication may have serious side effects.||
0931|043|S|However, you have been prescribed this drug because your doctor||
0931|044|S|has judged that the benefit to you is greater than the risk of||
0931|045|S|side effects. Careful monitoring by your doctor may decrease your||
0931|046|S|risk.||
0931|047|S|   Tell your doctor right away if you have any serious side||
0931|048|S|effects, including: easy bleeding/bruising, chest pain,||
0931|049|S|muscle/joint pain, muscle cramps, irregular heartbeat,||
0931|050|S|mental/mood changes (such as anxiety), dark urine, yellowing||
0931|051|S|eyes/skin.||
0931|052|S|   This medication may lower your ability to fight infections.||
0931|053|S|This may make you more likely to get a serious (rarely fatal)||
0931|054|S|infection or make any infection you have worse. Tell your doctor||
0931|055|S|right away if you have any signs of infection (such as sore||
0931|056|S|throat that doesn't go away, fever, chills).||
0931|057|S|   Azacitidine sometimes causes side effects due to the rapid||
0931|058|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
0931|059|S|risk, your doctor may add a medication and tell you to drink||
0931|060|S|plenty of fluids. Tell your doctor right away if you have||
0931|061|S|symptoms such as: low back/side pain (flank pain), signs of||
0931|062|S|kidney problems (such as painful urination, pink/bloody urine,||
0931|063|S|change in the amount of urine), muscle spasms/weakness.||
0931|064|S|   A very serious allergic reaction to this drug is rare.||
0931|065|S|However, get medical help right away if you notice any symptoms||
0931|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0931|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0931|068|S|breathing.||
0931|069|S|   This is not a complete list of possible side effects. If you||
0931|070|S|notice other effects not listed above, contact your doctor or||
0931|071|S|pharmacist.||
0931|072|S|   In the US -||
0931|073|S|   Call your doctor for medical advice about side effects. You||
0931|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0931|075|S|www.fda.gov/medwatch.||
0931|076|S|   In Canada - Call your doctor for medical advice about side||
0931|077|S|effects. You may report side effects to Health Canada at||
0931|078|S|1-866-234-2345.||
0931|079|B|||
0931|080|P|PRECAUTIONS:  Before using azacitidine, tell your doctor or||
0931|081|P|pharmacist if you are allergic to it; or if you have any other||
0931|082|P|allergies. This product may contain inactive ingredients (such as||
0931|083|P|mannitol), which can cause allergic reactions or other problems.||
0931|084|P|Talk to your pharmacist for more details.||
0931|085|P|   Before using this medication, tell your doctor or pharmacist||
0931|086|P|your medical history, especially of: kidney disease, liver||
0931|087|P|disease (including cancer).||
0931|088|P|   Azacitidine can make you more likely to get infections or may||
0931|089|P|make current infections worse. Stay away from anyone who has an||
0931|090|P|infection that may easily spread (such as chickenpox, COVID-19,||
0931|091|P|measles, flu). Talk to your doctor if you have been exposed to an||
0931|092|P|infection or for more details.||
0931|093|P|   Tell your health care professional that you are using||
0931|094|P|azacitidine before having any immunizations/vaccinations. Avoid||
0931|095|P|contact with people who have recently received live vaccines||
0931|096|P|(such as flu vaccine inhaled through the nose).||
0931|097|P|   To lower your risk of getting cut, bruised, or injured, use||
0931|098|P|caution with sharp objects like razors and nail cutters, and||
0931|099|P|avoid activities such as contact sports.||
0931|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0931|101|P|can make you more dizzy. Do not drive, use machinery, or do||
0931|102|P|anything that needs alertness until you can do it safely. Limit||
0931|103|P|alcoholic beverages. Talk to your doctor if you are using||
0931|104|P|marijuana (cannabis).||
0931|105|P|   Tell your doctor if you are pregnant or plan to become||
0931|106|P|pregnant. You should not become pregnant while using azacitidine.||
0931|107|P|Azacitidine may harm an unborn baby. Your doctor should order a||
0931|108|P|pregnancy test before you start this medication. Women using this||
0931|109|P|medication should ask about reliable forms of birth control||
0931|110|P|during treatment and for 6 months after the last dose. Men using||
0931|111|P|this medication should ask about reliable forms of birth control||
0931|112|P|during treatment and for some time after the last dose. If you or||
0931|113|P|your partner becomes pregnant, talk to your doctor right away||
0931|114|P|about the risks and benefits of this medication.||
0931|115|P|   It is unknown if this drug passes into breast milk. Because of||
0931|116|P|the possible risk to the infant, breastfeeding is not recommended||
0931|117|P|while using this drug and for 1 week after the last dose. Consult||
0931|118|P|your doctor before breastfeeding.||
0931|119|B|||
0931|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0931|121|I|medications work or increase your risk for serious side effects.||
0931|122|I|This document does not contain all possible drug interactions.||
0931|123|I|Keep a list of all the products you use (including||
0931|124|I|prescription/nonprescription drugs and herbal products) and share||
0931|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
0931|126|I|the dosage of any medicines without your doctor's approval.||
0931|127|B|||
0931|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0931|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0931|130|O|poison control center right away. US residents can call||
0931|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0931|132|B|||
0931|133|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
0931|134|N|kidney/liver function, blood mineral levels) should be done||
0931|135|N|before you start using this medication and while you are using||
0931|136|N|it. Keep all medical and lab appointments.||
0931|137|B|||
0931|138|D|MISSED DOSE:  It is important to get each dose of this medication||
0931|139|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0931|140|D|right away for a new dosing schedule.||
0931|141|B|||
0931|142|R|STORAGE:  Not applicable. This medication is given in a clinic||
0931|143|R|and will not be stored at home.||
0931|144|B|||
0931|145|M|MEDICAL ALERT:  Your condition can cause complications in a||
0931|146|M|medical emergency. For information about enrolling in MedicAlert,||
0931|147|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0931|148|B|||
0931|149|A|Information last revised April 2025.||
0931|150|A|Copyright(c) 2025 First Databank, Inc.||
0931|151|B|||
0932|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0932|002|Z|does NOT have all possible information about this product. This||
0932|003|Z|information does not assure that this product is safe, effective,||
0932|004|Z|or appropriate for you. This information is not individual||
0932|005|Z|medical advice and does not substitute for the advice of your||
0932|006|Z|health care professional. Always ask your health care||
0932|007|Z|professional for complete information about this product and your||
0932|008|Z|specific health needs.||
0932|009|B|||
0932|010|T|METHOXSALEN - INJECTION||
0932|011|F|(meth-OX-a-len)||
0932|012|B|||
0932|013|C|COMMON BRAND NAME(S): Uvadex||
0932|014|B|||
0932|015|U|USES:  This medication is used to treat cutaneous T-cell lymphoma||
0932|016|U|(CTCL), a type of cancer that affects the skin and blood and||
0932|017|U|sometimes the lymph nodes and other organs. CTCL is caused by the||
0932|018|U|uncontrolled growth of abnormal white blood cells in the skin.||
0932|019|U|This drug is used in a procedure called photopheresis. Some of||
0932|020|U|your blood is removed from your body through a vein and goes into||
0932|021|U|a special machine that separates the white blood cells. The||
0932|022|U|machine adds methoxsalen to these white blood cells, then shines||
0932|023|U|ultraviolet (UV) light on them. Then the machine returns the||
0932|024|U|treated cells (and the rest of your blood) to your body through||
0932|025|U|the same vein. Your immune system is thought to react to the||
0932|026|U|treated cells and other similar untreated T-cells that are not||
0932|027|U|working properly. This effect helps to restore your immune||
0932|028|U|balance and lessens the skin problems (such as rash, plaques,||
0932|029|U|tumors) of CTCL. Methoxsalen is known as a psoralen||
0932|030|U|photosensitizer. It works by making the treated white blood cells||
0932|031|U|more sensitive to UV light.||
0932|032|B|||
0932|033|H|HOW TO USE:  See Uses section.||
0932|034|H|   This medication is injected into your collected white blood||
0932|035|H|cells during photopheresis by a health care professional. This||
0932|036|H|medication is used as directed by your doctor, usually once a day||
0932|037|H|for 2 days in a row. Photopheresis is usually repeated every 4||
0932|038|H|weeks depending on your response to treatment.||
0932|039|H|   The dosage is based on your medical condition, the amount of||
0932|040|H|white blood cells collected, and response to treatment.||
0932|041|B|||
0932|042|S|SIDE EFFECTS:  See also Precautions section.||
0932|043|S|   Dizziness, headache, weakness, leg cramps, or bitter/sour||
0932|044|S|taste in the mouth may occur. Skin freckling, dry skin, and skin||
0932|045|S|aging may also occur. If these effects last or get worse, tell||
0932|046|S|your doctor or pharmacist promptly.||
0932|047|S|   Remember that this medication has been prescribed because your||
0932|048|S|doctor has judged that the benefit to you is greater than the||
0932|049|S|risk of side effects. Many people using this medication do not||
0932|050|S|have serious side effects.||
0932|051|S|   Tell your doctor right away if you have any serious side||
0932|052|S|effects, including: depression, swollen ankles/feet, new/unusual||
0932|053|S|skin sores, irregular heartbeat.||
0932|054|S|   A very serious allergic reaction to this drug is rare.||
0932|055|S|However, get medical help right away if you notice any symptoms||
0932|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0932|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0932|058|S|breathing.||
0932|059|S|   This is not a complete list of possible side effects. If you||
0932|060|S|notice other effects not listed above, contact your doctor or||
0932|061|S|pharmacist.||
0932|062|S|   In the US -||
0932|063|S|   Call your doctor for medical advice about side effects. You||
0932|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0932|065|S|www.fda.gov/medwatch.||
0932|066|S|   In Canada - Call your doctor for medical advice about side||
0932|067|S|effects. You may report side effects to Health Canada at||
0932|068|S|1-866-234-2345.||
0932|069|B|||
0932|070|P|PRECAUTIONS:  Before using methoxsalen, tell your doctor or||
0932|071|P|pharmacist if you are allergic to it; or to sunlight; or if you||
0932|072|P|have any other allergies. This product may contain inactive||
0932|073|P|ingredients, which can cause allergic reactions or other||
0932|074|P|problems. Talk to your pharmacist for more details.||
0932|075|P|   Before using this medication, tell your doctor or pharmacist||
0932|076|P|your medical history, especially of: unusual or bad reactions to||
0932|077|P|other psoralen products, conditions that make you sensitive to||
0932|078|P|light (such as lupus, certain porphyrias, xeroderma pigmentosum,||
0932|079|P|albinism), removal of natural lens in the eye, coal tar/UVA||
0932|080|P|treatment, radiation treatment, arsenic treatments, other skin||
0932|081|P|cancer (melanoma, basal cell or squamous cell carcinomas),||
0932|082|P|cataracts, liver problems, kidney problems, heart problems.||
0932|083|P|   For 24 hours after treatment with this medication, your eyes||
0932|084|P|and skin will be more sensitive to the sun, including sunlight||
0932|085|P|through a glass window. Limit your time in the sun. Avoid tanning||
0932|086|P|booths and sunlamps. To protect your skin during this time, use||
0932|087|P|sunscreen and wear protective clothing when outdoors. To protect||
0932|088|P|your eyes, wear dark wrap-around UV-absorbing sunglasses. Tell||
0932|089|P|your doctor right away if you have vision changes, skin||
0932|090|P|blisters/redness/swelling/peeling, or if you get sunburned. Ask||
0932|091|P|your doctor for details.||
0932|092|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0932|093|P|can make you more dizzy. Do not drive, use machinery, or do||
0932|094|P|anything that needs alertness until you can do it safely. Limit||
0932|095|P|alcoholic beverages. Talk to your doctor if you are using||
0932|096|P|marijuana (cannabis).||
0932|097|P|   Tell your doctor if you are pregnant or plan to become||
0932|098|P|pregnant. You should not become pregnant while using methoxsalen.||
0932|099|P|Methoxsalen may harm an unborn baby. If you become pregnant, talk||
0932|100|P|to your doctor right away about the risks and benefits of this||
0932|101|P|medication.||
0932|102|P|   It is unknown if this drug passes into breast milk. Because of||
0932|103|P|the possible risk to the infant, breastfeeding is not recommended||
0932|104|P|while using this drug. Consult your doctor before breastfeeding.||
0932|105|B|||
0932|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0932|107|I|medications work or increase your risk for serious side effects.||
0932|108|I|This document does not contain all possible drug interactions.||
0932|109|I|Keep a list of all the products you use (including||
0932|110|I|prescription/nonprescription drugs and herbal products) and share||
0932|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
0932|112|I|the dosage of any medicines without your doctor's approval.||
0932|113|I|   A product that may interact with this drug is: fezolinetant.||
0932|114|B|||
0932|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0932|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0932|117|O|poison control center right away. US residents can call||
0932|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0932|119|O|Symptoms of overdose may include: serious burning/blistering of||
0932|120|O|skin.||
0932|121|B|||
0932|122|N|NOTES:  Lab and/or medical tests (such as blood counts) should be||
0932|123|N|done while you are using this medication. Keep all medical and||
0932|124|N|lab appointments. Consult your doctor for more details.||
0932|125|B|||
0932|126|D|MISSED DOSE:  It is important to get each scheduled treatment||
0932|127|D|with this medication as directed. If you miss a treatment, ask||
0932|128|D|your doctor for a new treatment schedule.||
0932|129|B|||
0932|130|R|STORAGE:  Not applicable. This medication is given in a hospital||
0932|131|R|or clinic and will not be stored at home.||
0932|132|B|||
0932|133|A|Information last revised May 2024.||
0932|134|A|Copyright(c) 2025 First Databank, Inc.||
0932|135|B|||
0933|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0933|002|Z|does NOT have all possible information about this product. This||
0933|003|Z|information does not assure that this product is safe, effective,||
0933|004|Z|or appropriate for you. This information is not individual||
0933|005|Z|medical advice and does not substitute for the advice of your||
0933|006|Z|health care professional. Always ask your health care||
0933|007|Z|professional for complete information about this product and your||
0933|008|Z|specific health needs.||
0933|009|B|||
0933|010|T|DECONGESTANT/DEXTROMETHORPHAN/ACETAMINOPHEN/GUAIFENESIN - ORAL||
0933|011|B|||
0933|012|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
0933|013|W|too much acetaminophen may cause serious (possibly fatal) liver||
0933|014|W|disease. Adults should not take more than 4000 milligrams (4||
0933|015|W|grams) of acetaminophen a day. People with liver problems and||
0933|016|W|children should take less acetaminophen. Ask your doctor or||
0933|017|W|pharmacist how much acetaminophen is safe to take.||
0933|018|W|   Do not use with any other drug containing acetaminophen||
0933|019|W|without asking your doctor or pharmacist first. Acetaminophen is||
0933|020|W|in many nonprescription and prescription medications (such as||
0933|021|W|pain/fever drugs or cough-and-cold products). Check the labels on||
0933|022|W|all your medicines to see if they contain acetaminophen, and ask||
0933|023|W|your pharmacist if you are unsure.||
0933|024|W|   Get medical help right away if you take too much acetaminophen||
0933|025|W|(overdose), even if you feel well. Overdose symptoms may include||
0933|026|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
0933|027|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
0933|028|W|   Daily alcohol use, especially when combined with||
0933|029|W|acetaminophen, may damage your liver. Avoid alcohol.||
0933|030|B|||
0933|031|U|USES:  This combination medication is used to temporarily treat||
0933|032|U|cough, chest congestion, fever, body aches, and stuffy nose||
0933|033|U|symptoms caused by the common cold, flu, or other breathing||
0933|034|U|illnesses (such as sinusitis, bronchitis). Guaifenesin is an||
0933|035|U|expectorant that helps to thin and loosen mucus in the lungs,||
0933|036|U|making it easier to cough up the mucus. Dextromethorphan is a||
0933|037|U|cough suppressant that affects a certain part of the brain (cough||
0933|038|U|center), reducing the urge to cough. Decongestants help to||
0933|039|U|relieve stuffy nose symptoms. This product also contains||
0933|040|U|acetaminophen (APAP), a non-aspirin pain reliever and fever||
0933|041|U|reducer.||
0933|042|U|   This medication is not usually used for ongoing coughs from||
0933|043|U|smoking, asthma, other long-term breathing problems (such as||
0933|044|U|emphysema), or coughs with a lot of mucus unless directed by your||
0933|045|U|doctor.||
0933|046|U|   Cough-and-cold products have not been shown to be safe or||
0933|047|U|effective in children younger than 6 years. Do not use this||
0933|048|U|product to treat cold symptoms in children younger than 6 years||
0933|049|U|unless specifically directed by the doctor. Some products (such||
0933|050|U|as long-acting tablets/capsules) are not recommended for use in||
0933|051|U|children younger than 12 years. Ask your doctor or pharmacist for||
0933|052|U|more details about using your product safely.||
0933|053|U|   These products do not cure or shorten the length of the common||
0933|054|U|cold and may cause serious side effects. To decrease the risk for||
0933|055|U|serious side effects, carefully follow all dosage directions. Do||
0933|056|U|not use this product to make a child sleepy. Do not give other||
0933|057|U|cough-and-cold medication that might contain the same or similar||
0933|058|U|ingredients (see also Drug Interactions section). Ask the doctor||
0933|059|U|or pharmacist about other ways to relieve cough and cold symptoms||
0933|060|U|(such as drinking enough fluids, using a humidifier or saline||
0933|061|U|nose drops/spray).||
0933|062|B|||
0933|063|H|HOW TO USE:  See also Warning section.||
0933|064|H|   If you are using the over-the-counter product, read and follow||
0933|065|H|all directions on the product package before taking this||
0933|066|H|medication.||
0933|067|H|   Take this medication by mouth with or without food, usually||
0933|068|H|every 4 to 6 hours as needed, or as directed by your doctor.||
0933|069|H|Drink plenty of fluids when you use this medication unless||
0933|070|H|otherwise directed by your doctor. The fluid will help loosen the||
0933|071|H|mucus in your lungs.||
0933|072|H|   If you are using a liquid form, carefully measure your dose||
0933|073|H|using a medication-measuring device or spoon. Do not use a||
0933|074|H|household spoon because you may not get the correct dose. For||
0933|075|H|some liquid products, you may need to shake the bottle well||
0933|076|H|before each dose. Check the directions on the product package.||
0933|077|H|   The dosage is based on your age, medical condition, and||
0933|078|H|response to treatment. Do not increase your dose or take this||
0933|079|H|medication more often than directed without your doctor's||
0933|080|H|approval. Improper use of this medication (abuse) may result in||
0933|081|H|serious harm (such as brain damage, seizure, death).||
0933|082|H|   Tell your doctor if your condition lasts for more than 5 to 7||
0933|083|H|days, if it gets worse, or if it occurs with headache that||
0933|084|H|doesn't go away, rash, or fever lasting more than 3 days. These||
0933|085|H|may be symptoms of a serious medical problem and should be||
0933|086|H|checked by a doctor.||
0933|087|B|||
0933|088|S|SIDE EFFECTS:  See also Warning section.||
0933|089|S|   Dizziness, drowsiness, headache, nausea, nervousness, or||
0933|090|S|trouble sleeping may occur. If any of these effects last or get||
0933|091|S|worse, contact your doctor or pharmacist promptly.||
0933|092|S|   If your doctor has prescribed this medication, remember that||
0933|093|S|your doctor has judged that the benefit to you is greater than||
0933|094|S|the risk of side effects. Many people using this medication do||
0933|095|S|not have serious side effects.||
0933|096|S|   This medication may raise your blood pressure. Check your||
0933|097|S|blood pressure regularly and tell your doctor if the results are||
0933|098|S|high.||
0933|099|S|   Tell your doctor right away if you have any serious side||
0933|100|S|effects, including: mental/mood changes (such as confusion,||
0933|101|S|hallucinations), shaking (tremors), weakness, problems urinating,||
0933|102|S|fast/slow/irregular heartbeat.||
0933|103|S|   A very serious allergic reaction to this drug is rare.||
0933|104|S|However, get medical help right away if you notice any symptoms||
0933|105|S|of a serious allergic reaction, including: rash, itching/swelling||
0933|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0933|107|S|breathing.||
0933|108|S|   This is not a complete list of possible side effects. If you||
0933|109|S|notice other effects not listed above, contact your doctor or||
0933|110|S|pharmacist.||
0933|111|S|   In the US -||
0933|112|S|   Call your doctor for medical advice about side effects. You||
0933|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0933|114|S|www.fda.gov/medwatch.||
0933|115|S|   In Canada - Call your doctor for medical advice about side||
0933|116|S|effects. You may report side effects to Health Canada at||
0933|117|S|1-866-234-2345.||
0933|118|B|||
0933|119|P|PRECAUTIONS:  See also Warning section.||
0933|120|P|   Before taking this medication, tell your doctor or pharmacist||
0933|121|P|if you are allergic to any of its ingredients; or if you have any||
0933|122|P|other allergies. This product may contain inactive ingredients,||
0933|123|P|which can cause allergic reactions or other problems. Talk to||
0933|124|P|your pharmacist for more details.||
0933|125|P|   Before using this medication, tell your doctor or pharmacist||
0933|126|P|your medical history, especially of: breathing problems (such as||
0933|127|P|asthma, emphysema), diabetes, a certain eye problem (glaucoma),||
0933|128|P|heart problems, high blood pressure, kidney problems, liver||
0933|129|P|disease, overactive thyroid (hyperthyroidism), trouble urinating||
0933|130|P|(such as due to enlarged prostate), use/abuse of alcohol.||
0933|131|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0933|132|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0933|133|P|machinery, or do anything that needs alertness until you can do||
0933|134|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0933|135|P|are using marijuana (cannabis).||
0933|136|P|   Liquid forms of this product may contain sugar, alcohol, or||
0933|137|P|aspartame. Caution is advised if you have diabetes, alcohol||
0933|138|P|dependence, liver disease, phenylketonuria (PKU), or any other||
0933|139|P|condition that requires you to limit/avoid these substances in||
0933|140|P|your diet. Ask your doctor or pharmacist about using this product||
0933|141|P|safely.||
0933|142|P|   Before having surgery, tell your doctor or dentist about all||
0933|143|P|the products you use (including prescription drugs,||
0933|144|P|nonprescription drugs, and herbal products).||
0933|145|P|   Older adults may be more sensitive to the side effects of this||
0933|146|P|drug, especially fast/irregular heartbeat, dizziness, problems||
0933|147|P|urinating, trouble sleeping, or confusion.||
0933|148|P|   During pregnancy, this medication should be used only if||
0933|149|P|clearly needed. Discuss the risks and benefits with your doctor.||
0933|150|P|   This medication may pass into breast milk. Consult your doctor||
0933|151|P|before breastfeeding.||
0933|152|B|||
0933|153|I|DRUG INTERACTIONS:  See also Warning section.||
0933|154|I|   Drug interactions may change how your medications work or||
0933|155|I|increase your risk for serious side effects. This document does||
0933|156|I|not contain all possible drug interactions. Keep a list of all||
0933|157|I|the products you use (including prescription/nonprescription||
0933|158|I|drugs and herbal products) and share it with your doctor and||
0933|159|I|pharmacist. Do not start, stop, or change the dosage of any||
0933|160|I|medicines without your doctor's approval.||
0933|161|I|   Taking certain MAO inhibitors with this medication may cause a||
0933|162|I|serious (possibly fatal) drug interaction. Avoid taking||
0933|163|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
0933|164|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
0933|165|I|tranylcypromine during treatment with this medication. Most MAO||
0933|166|I|inhibitors should also not be taken for two weeks before||
0933|167|I|treatment with this medication. Ask your doctor when to start or||
0933|168|I|stop taking this medication.||
0933|169|I|   Some products that may interact with this drug are:||
0933|170|I|ketoconazole, levoketoconazole, rolapitant.||
0933|171|I|   The ingredients in this product are available in many||
0933|172|I|prescription and nonprescription products. Check the labels on||
0933|173|I|all your medications carefully to make sure you are not taking||
0933|174|I|more than one product with the same ingredient(s). Consult your||
0933|175|I|pharmacist if you are unsure of the ingredients in any of your||
0933|176|I|medications.||
0933|177|I|   Tell your doctor or pharmacist if you are taking other||
0933|178|I|products that cause drowsiness such as opioid pain or cough||
0933|179|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0933|180|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0933|181|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0933|182|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0933|183|I|diphenhydramine).||
0933|184|I|   Check the labels on all your medicines (such as allergy or||
0933|185|I|cough-and-cold products) because they may contain ingredients||
0933|186|I|that cause drowsiness. Ask your pharmacist about using those||
0933|187|I|products safely.||
0933|188|I|   This medication may interfere with certain urine lab tests||
0933|189|I|(such as 5-HIAA levels, VMA levels), possibly causing false test||
0933|190|I|results. Make sure lab personnel and all your doctors know you||
0933|191|I|use this drug.||
0933|192|B|||
0933|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0933|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0933|195|O|poison control center right away. US residents can call||
0933|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0933|197|O|Symptoms of overdose may include: nausea, vomiting, loss of||
0933|198|O|appetite, sweating, stomach/abdominal pain, extreme tiredness,||
0933|199|O|yellowing eyes/skin, dark urine, agitation, confusion,||
0933|200|O|hallucinations, seizures.||
0933|201|B|||
0933|202|N|NOTES:  If your doctor has prescribed this medication for you, do||
0933|203|N|not share it with others.||
0933|204|N|   Keep all medical and lab appointments.||
0933|205|B|||
0933|206|D|MISSED DOSE:  If you are taking this medication on a regular||
0933|207|D|schedule and you miss a dose, take it as soon as you remember. If||
0933|208|D|it is near the time of the next dose, skip the missed dose. Take||
0933|209|D|your next dose at the regular time. Do not double the dose to||
0933|210|D|catch up.||
0933|211|B|||
0933|212|R|STORAGE:  Store at room temperature away from light and moisture.||
0933|213|R|Do not store in the bathroom. Keep all medications away from||
0933|214|R|children and pets.||
0933|215|R|   Do not flush medications down the toilet or pour them into a||
0933|216|R|drain unless instructed to do so. Properly discard this product||
0933|217|R|when it is expired or no longer needed. Consult your pharmacist||
0933|218|R|or local waste disposal company.||
0933|219|B|||
0933|220|A|Information last revised July 2025.||
0933|221|A|Copyright(c) 2025 First Databank, Inc.||
0933|222|B|||
0934|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0934|002|Z|does NOT have all possible information about this product. This||
0934|003|Z|information does not assure that this product is safe, effective,||
0934|004|Z|or appropriate for you. This information is not individual||
0934|005|Z|medical advice and does not substitute for the advice of your||
0934|006|Z|health care professional. Always ask your health care||
0934|007|Z|professional for complete information about this product and your||
0934|008|Z|specific health needs.||
0934|009|B|||
0934|010|T|SALBUTAMOL (ALBUTEROL) - INJECTION||
0934|011|F|(sal-BUE-ta-mol/al-BUE-ter-ol)||
0934|012|B|||
0934|013|U|USES:  Salbutamol (also known as albuterol) is used to treat||
0934|014|U|wheezing and shortness of breath caused by breathing problems||
0934|015|U|(such as asthma, bronchitis, emphysema). Salbutamol belongs to a||
0934|016|U|class of drugs known as bronchodilators. It works by relaxing the||
0934|017|U|muscles around the airways so that they open up and you can||
0934|018|U|breathe more easily.||
0934|019|B|||
0934|020|V|OTHER USES:  This section contains uses of this drug that are not||
0934|021|V|listed in the approved professional labeling for the drug but||
0934|022|V|that may be prescribed by your health care professional. Use this||
0934|023|V|drug for a condition that is listed in this section only if it||
0934|024|V|has been so prescribed by your health care professional.||
0934|025|V|   Although this use is not recommended by the manufacturer, this||
0934|026|V|medication has also been used by pregnant women to stop early||
0934|027|V|labor.||
0934|028|B|||
0934|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0934|030|H|from your pharmacist before you start receiving salbutamol by||
0934|031|H|injection. If you have any questions, ask your doctor or||
0934|032|H|pharmacist.||
0934|033|H|   This medication is given by injection into a vein as directed||
0934|034|H|by your doctor, usually by a health care professional. The dosage||
0934|035|H|is based on your medical condition and response to treatment.||
0934|036|H|   Tell your doctor if your condition does not get better or if||
0934|037|H|it gets worse.||
0934|038|B|||
0934|039|S|SIDE EFFECTS:  Nervousness, dizziness, shaking (tremor), trouble||
0934|040|S|sleeping, headache, nausea, vomiting, or pain at the injection||
0934|041|S|site may occur. If any of these effects last or get worse, tell||
0934|042|S|your doctor or pharmacist promptly.||
0934|043|S|   Remember that this medication has been prescribed because your||
0934|044|S|doctor has judged that the benefit to you is greater than the||
0934|045|S|risk of side effects. Many people using this medication do not||
0934|046|S|have serious side effects.||
0934|047|S|   This medication may raise your blood pressure. Check your||
0934|048|S|blood pressure regularly and tell your doctor if the results are||
0934|049|S|high.||
0934|050|S|   Tell your doctor right away if you have any serious side||
0934|051|S|effects, including: fast/pounding/irregular heartbeat, muscle||
0934|052|S|cramps/weakness, increased thirst/urination.||
0934|053|S|   Get medical help right away if you have any very serious side||
0934|054|S|effects, including: chest pain, rapid breathing, confusion.||
0934|055|S|   Rarely, this medication has caused severe (rarely fatal),||
0934|056|S|sudden worsening of breathing problems/asthma (paradoxical||
0934|057|S|bronchospasm). If you experience sudden wheezing, get medical||
0934|058|S|help right away.||
0934|059|S|   A very serious allergic reaction to this drug is rare.||
0934|060|S|However, get medical help right away if you notice any symptoms||
0934|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0934|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0934|063|S|breathing.||
0934|064|S|   This is not a complete list of possible side effects. If you||
0934|065|S|notice other effects not listed above, contact your doctor or||
0934|066|S|pharmacist.||
0934|067|S|   In the US -||
0934|068|S|   Call your doctor for medical advice about side effects. You||
0934|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0934|070|S|www.fda.gov/medwatch.||
0934|071|S|   In Canada - Call your doctor for medical advice about side||
0934|072|S|effects. You may report side effects to Health Canada at||
0934|073|S|1-866-234-2345.||
0934|074|B|||
0934|075|P|PRECAUTIONS:  Before using salbutamol, tell your doctor or||
0934|076|P|pharmacist if you are allergic to it; or to similar drugs (such||
0934|077|P|as levalbuterol, metaproterenol, salmeterol); or if you have any||
0934|078|P|other allergies. This product may contain inactive ingredients,||
0934|079|P|which can cause allergic reactions or other problems. Talk to||
0934|080|P|your pharmacist for more details.||
0934|081|P|   Before using this medication, tell your doctor or pharmacist||
0934|082|P|your medical history, especially of: diabetes, heart problems||
0934|083|P|(such as irregular heartbeat, angina, previous heart attack),||
0934|084|P|high blood pressure, seizure, low blood potassium level||
0934|085|P|(hypokalemia).||
0934|086|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0934|087|P|can make you more dizzy. Do not drive, use machinery, or do||
0934|088|P|anything that needs alertness until you can do it safely. Limit||
0934|089|P|alcoholic beverages. Talk to your doctor if you are using||
0934|090|P|marijuana (cannabis).||
0934|091|P|   Before having surgery, tell your doctor or dentist about all||
0934|092|P|the products you use (including prescription drugs,||
0934|093|P|nonprescription drugs, and herbal products).||
0934|094|P|   During pregnancy, this medication should be used only when||
0934|095|P|clearly needed. It is not recommended for use during the first or||
0934|096|P|second trimester of pregnancy by women who have an increased risk||
0934|097|P|of miscarriage. Discuss the risks and benefits with your doctor.||
0934|098|P|   It is unknown if this drug passes into breast milk. Consult||
0934|099|P|your doctor before breastfeeding.||
0934|100|B|||
0934|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0934|102|I|medications work or increase your risk for serious side effects.||
0934|103|I|This document does not contain all possible drug interactions.||
0934|104|I|Keep a list of all the products you use (including||
0934|105|I|prescription/nonprescription drugs and herbal products) and share||
0934|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
0934|107|I|the dosage of any medicines without your doctor's approval.||
0934|108|B|||
0934|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0934|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0934|111|O|poison control center right away. US residents can call||
0934|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0934|113|O|Symptoms of overdose may include: chest pain,||
0934|114|O|fast/pounding/irregular heartbeat, headache, shaking (tremors),||
0934|115|O|nervousness, weakness, severe dizziness, seizures.||
0934|116|B|||
0934|117|N|NOTES:  Lab and/or medical tests (such as blood pressure, heart||
0934|118|N|rate, EKG, blood potassium levels, blood sugar levels, lung||
0934|119|N|function) may be done while you are using this medication. Keep||
0934|120|N|all medical and lab appointments. Consult your doctor for more||
0934|121|N|details.||
0934|122|N|   Avoid allergens/irritants that can worsen breathing problems,||
0934|123|N|such as smoke, pollen, pet dander, dust, or molds.||
0934|124|N|   Learn to use a peak flow meter, use it daily, and promptly||
0934|125|N|report worsening breathing problems (such as readings in the||
0934|126|N|yellow/red range, increased use of quick-relief inhalers).||
0934|127|N|   Because the flu virus can worsen breathing problems, ask your||
0934|128|N|doctor or pharmacist if you should have a flu shot every year.||
0934|129|B|||
0934|130|D|MISSED DOSE:  Not applicable.||
0934|131|B|||
0934|132|R|STORAGE:  Not applicable. This medication is given in a hospital||
0934|133|R|or clinic and will not be stored at home.||
0934|134|B|||
0934|135|M|MEDICAL ALERT:  Your condition can cause complications in a||
0934|136|M|medical emergency. For information about enrolling in MedicAlert,||
0934|137|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0934|138|B|||
0934|139|A|Information last revised October 2024.||
0934|140|A|Copyright(c) 2025 First Databank, Inc.||
0934|141|B|||
0935|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0935|002|Z|does NOT have all possible information about this product. This||
0935|003|Z|information does not assure that this product is safe, effective,||
0935|004|Z|or appropriate for you. This information is not individual||
0935|005|Z|medical advice and does not substitute for the advice of your||
0935|006|Z|health care professional. Always ask your health care||
0935|007|Z|professional for complete information about this product and your||
0935|008|Z|specific health needs.||
0935|009|B|||
0935|010|T|PANITUMUMAB - INJECTION||
0935|011|F|(pan-i-TOOM-ue-mab)||
0935|012|B|||
0935|013|C|COMMON BRAND NAME(S): Vectibix||
0935|014|B|||
0935|015|W|WARNING:  Panitumumab has caused very serious skin reactions,||
0935|016|W|which can sometimes lead to serious infections. Tell your doctor||
0935|017|W|right away if you develop any signs of a skin reaction, including||
0935|018|W|acne, mild rash/itching, warmth/redness/swelling of the skin||
0935|019|W|(including around the nails), dry/flaking skin, or skin sores||
0935|020|W|(especially with pus). Get medical help right away if you develop||
0935|021|W|any signs of a serious infection (such as sepsis), including||
0935|022|W|fever, fast heartbeat, mental/mood changes (such as confusion),||
0935|023|W|or signs of kidney problems (such as change in the amount of||
0935|024|W|urine).||
0935|025|B|||
0935|026|U|USES:  This medication is used to treat a certain type of cancer||
0935|027|U|of the colon (large intestine) or rectum. Panitumumab is a||
0935|028|U|man-made protein (monoclonal antibody) that binds to a certain||
0935|029|U|protein (epidermal growth factor receptor-EGFR). It works by||
0935|030|U|slowing or stopping the growth of cancer cells.||
0935|031|B|||
0935|032|H|HOW TO USE:  This medication is given by injection into a vein by||
0935|033|H|a health care professional. It is given as directed by your||
0935|034|H|doctor, usually every 14 days. The dosage is based on your weight||
0935|035|H|and response to treatment.||
0935|036|H|   Infusion reactions may happen during the infusion of this||
0935|037|H|drug. Tell your doctor right away if you have any symptoms of||
0935|038|H|infusion reactions such as fever, chills, shortness of breath, or||
0935|039|H|dizziness. Your doctor may slow down or stop your treatment for||
0935|040|H|some time.||
0935|041|B|||
0935|042|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
0935|043|S|   Diarrhea, nausea, vomiting, tiredness, constipation, abdominal||
0935|044|S|pain, and growth of eyelashes may occur. If any of these effects||
0935|045|S|last or get worse, tell your doctor or pharmacist promptly.||
0935|046|S|   Remember that this medication has been prescribed because your||
0935|047|S|doctor has judged that the benefit to you is greater than the||
0935|048|S|risk of side effects. Many people using this medication do not||
0935|049|S|have serious side effects.||
0935|050|S|   Tell your doctor right away if you have any serious side||
0935|051|S|effects, including: swelling ankles/feet, unusual weakness,||
0935|052|S|irregular heartbeat, severe muscle spasms, mouth sores, signs of||
0935|053|S|eye problems (such as eye redness/itching/irritation, watery||
0935|054|S|eyes, vision changes), signs of lung disease (such as cough,||
0935|055|S|shortness of breath), menstrual changes.||
0935|056|S|   Prolonged and/or severe diarrhea may lead to dehydration and||
0935|057|S|electrolyte imbalance. Tell your doctor right away if you develop||
0935|058|S|any of the following: extreme thirst, decreased urination,||
0935|059|S|dizziness, fainting.||
0935|060|S|   Get medical help right away if you have any very serious side||
0935|061|S|effects, including: seizures.||
0935|062|S|   A very serious allergic reaction to this drug is rare.||
0935|063|S|However, get medical help right away if you notice any symptoms||
0935|064|S|of a serious allergic reaction, including: rash, itching/swelling||
0935|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0935|066|S|breathing.||
0935|067|S|   This is not a complete list of possible side effects. If you||
0935|068|S|notice other effects not listed above, contact your doctor or||
0935|069|S|pharmacist.||
0935|070|S|   In the US -||
0935|071|S|   Call your doctor for medical advice about side effects. You||
0935|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0935|073|S|www.fda.gov/medwatch.||
0935|074|S|   In Canada - Call your doctor for medical advice about side||
0935|075|S|effects. You may report side effects to Health Canada at||
0935|076|S|1-866-234-2345.||
0935|077|B|||
0935|078|P|PRECAUTIONS:  Before receiving panitumumab, tell your doctor or||
0935|079|P|pharmacist if you are allergic to it; or if you have any other||
0935|080|P|allergies. This product may contain inactive ingredients, which||
0935|081|P|can cause allergic reactions or other problems. Talk to your||
0935|082|P|pharmacist for more details.||
0935|083|P|   Before using this medication, tell your doctor or pharmacist||
0935|084|P|your medical history, especially of: lung disease (such as||
0935|085|P|pulmonary fibrosis, interstitial pneumonitis), low||
0935|086|P|magnesium/calcium blood levels.||
0935|087|P|   Sunlight may worsen any skin reactions that may occur while||
0935|088|P|you are receiving this drug. Limit your time in the sun. Avoid||
0935|089|P|tanning booths and sunlamps. Use sunscreen and wear protective||
0935|090|P|clothing when outdoors.||
0935|091|P|   Before having surgery, tell your doctor or dentist about all||
0935|092|P|the products you use (including prescription drugs,||
0935|093|P|nonprescription drugs, and herbal products).||
0935|094|P|   Tell your doctor if you are pregnant or plan to become||
0935|095|P|pregnant. You should not become pregnant while using panitumumab.||
0935|096|P|Panitumumab may harm an unborn baby. Ask about reliable forms of||
0935|097|P|birth control while using this medication and for 2 months after||
0935|098|P|the last dose. If you become pregnant, talk to your doctor right||
0935|099|P|away about the risks and benefits of this medication.||
0935|100|P|   Based on information from related drugs, this medication may||
0935|101|P|pass into breast milk. Breastfeeding is not recommended while||
0935|102|P|using this medication and for 2 months after the last dose.||
0935|103|P|Consult your doctor before breastfeeding.||
0935|104|B|||
0935|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0935|106|I|medications work or increase your risk for serious side effects.||
0935|107|I|This document does not contain all possible drug interactions.||
0935|108|I|Keep a list of all the products you use (including||
0935|109|I|prescription/nonprescription drugs and herbal products) and share||
0935|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0935|111|I|the dosage of any medicines without your doctor's approval.||
0935|112|B|||
0935|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0935|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0935|115|O|poison control center right away. US residents can call||
0935|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0935|117|B|||
0935|118|N|NOTES:  Lab and/or medical tests (such as magnesium/calcium||
0935|119|N|levels) should be done before you start using this medication,||
0935|120|N|while you are using it and for 8 weeks after completion of||
0935|121|N|treatment. Keep all medical and lab appointments. Consult your||
0935|122|N|doctor for more details.||
0935|123|B|||
0935|124|D|MISSED DOSE:  It is important to get each dose of this medication||
0935|125|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0935|126|D|right away for a new dosing schedule.||
0935|127|B|||
0935|128|R|STORAGE:  Not applicable. This medication is given in a clinic||
0935|129|R|and will not be stored at home.||
0935|130|B|||
0935|131|A|Information last revised May 2024.||
0935|132|A|Copyright(c) 2025 First Databank, Inc.||
0935|133|B|||
0936|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0936|002|Z|does NOT have all possible information about this product. This||
0936|003|Z|information does not assure that this product is safe, effective,||
0936|004|Z|or appropriate for you. This information is not individual||
0936|005|Z|medical advice and does not substitute for the advice of your||
0936|006|Z|health care professional. Always ask your health care||
0936|007|Z|professional for complete information about this product and your||
0936|008|Z|specific health needs.||
0936|009|B|||
0936|010|T|ECULIZUMAB - INJECTION||
0936|011|F|(e-kue-LIZ-oo-mab)||
0936|012|B|||
0936|013|C|COMMON BRAND NAME(S): Bkemv, Epysqli, Soliris||
0936|014|B|||
0936|015|W|WARNING:  Eculizumab can lower your body's ability to fight an||
0936|016|W|infection. It can increase your chance of getting a very serious||
0936|017|W|(possibly fatal) brain/spinal cord infection (meningitis). Get||
0936|018|W|medical help right away if you develop any signs of a severe||
0936|019|W|infection (including meningitis), such as nausea/vomiting that||
0936|020|W|doesn't stop, high fever, chills, severe headache, stiff neck,||
0936|021|W|mental/mood changes (such as confusion), eye sensitivity to||
0936|022|W|light.||
0936|023|W|   You should receive the vaccine for meningitis (meningococcal||
0936|024|W|vaccine) at least 2 weeks before receiving this medication. If||
0936|025|W|you have been previously vaccinated for meningitis, ask your||
0936|026|W|doctor if you need to be vaccinated again before receiving this||
0936|027|W|medication. The vaccine will protect most people, but meningitis||
0936|028|W|may occur even in people who have been vaccinated. You should||
0936|029|W|still watch for signs of meningitis even if you receive the||
0936|030|W|vaccine. Consult your doctor for more details.||
0936|031|W|   To receive eculizumab in the United States, you must||
0936|032|W|understand, agree to, and carefully follow the requirements of||
0936|033|W|the REMS Program for this medication. If you live in Canada or||
0936|034|W|any other country, consult your doctor and pharmacist for your||
0936|035|W|country's regulations.||
0936|036|B|||
0936|037|U|USES:  This medication is used to treat a certain blood disorder||
0936|038|U|(paroxysmal nocturnal hemoglobinuria). This disorder can cause a||
0936|039|U|decrease in red blood cells (anemia). This medication helps to||
0936|040|U|block the decrease in red blood cells and can improve the||
0936|041|U|symptoms of anemia (such as tiredness, shortness of breath) and||
0936|042|U|decrease the need for blood transfusions.||
0936|043|U|   This medication may also be used to treat a certain immune||
0936|044|U|system disorder (atypical Hemolytic Uremic Syndrome). It helps to||
0936|045|U|prevent blood clots caused by this disorder.||
0936|046|U|   Eculizumab is also used to treat a certain muscle condition||
0936|047|U|(generalized Myasthenia Gravis). It may help to improve symptoms||
0936|048|U|of this condition (such as difficulty swallowing, trouble||
0936|049|U|breathing).||
0936|050|U|   Eculizumab is also used to treat a certain nervous system||
0936|051|U|disorder that affects the spinal cord and eye nerve||
0936|052|U|(neuromyelitis optica spectrum disorder). It may help to reduce||
0936|053|U|the number of hospital stays due to the disease.||
0936|054|U|   This monograph is about the following eculizumab products:||
0936|055|U|eculizumab, eculizumab-aagh, eculizumab-aeeb.||
0936|056|B|||
0936|057|H|HOW TO USE:  Read the Medication Guide provided by your||
0936|058|H|pharmacist before you start using eculizumab and each time you||
0936|059|H|get an infusion. Carry the Patient Safety Card with you at all||
0936|060|H|times during treatment and for 3 months after your last dose of||
0936|061|H|eculizumab. If you have any questions, consult your doctor or||
0936|062|H|pharmacist.||
0936|063|H|   This medication is given by injection into a vein by a health||
0936|064|H|care professional as directed by your doctor. The dosage is based||
0936|065|H|on your medical condition. Children's dosage is also based on||
0936|066|H|weight.||
0936|067|H|   Infusion reactions may happen during the infusion of this||
0936|068|H|drug. Tell your doctor right away if you have any symptoms of||
0936|069|H|infusion reactions such as shortness of breath, chest||
0936|070|H|pain/tightness, dizziness, or feeling faint.||
0936|071|H|   Do not stop receiving this medication without consulting your||
0936|072|H|doctor. Your condition may become worse when the drug is stopped.||
0936|073|H|If you do stop receiving the medication, you may need to be||
0936|074|H|monitored by your doctor for at least 8 or 12 weeks to make sure||
0936|075|H|that your condition does not worsen. Consult your doctor for more||
0936|076|H|details and for symptoms to watch out for.||
0936|077|H|   Tell your doctor if your condition does not get better or if||
0936|078|H|it gets worse.||
0936|079|B|||
0936|080|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
0936|081|S|   Headache, diarrhea, nausea, or vomiting may occur. If any of||
0936|082|S|these effects last or get worse, tell your doctor or pharmacist||
0936|083|S|promptly.||
0936|084|S|   Remember that this medication has been prescribed because your||
0936|085|S|doctor has judged that the benefit to you is greater than the||
0936|086|S|risk of side effects. Many people using this medication do not||
0936|087|S|have serious side effects.||
0936|088|S|   Tell your doctor right away if you have any serious side||
0936|089|S|effects, including: signs of infection (such as sore throat that||
0936|090|S|doesn't go away, fever, painful/frequent urination), swelling||
0936|091|S|hands/ankles/feet, fast heartbeat, signs of kidney problems (such||
0936|092|S|as change in the amount of urine).||
0936|093|S|   If you have used a similar medication recently (C5 inhibitors||
0936|094|S|such as crovalimab, ravulizumab), you may be at increased risk||
0936|095|S|for other immune system problems. Tell your doctor right away if||
0936|096|S|you have symptoms such as: joint/muscle/bone pain,||
0936|097|S|numbness/tingling of the hands/feet, unusual tiredness/weakness,||
0936|098|S|stomach/abdominal pain.||
0936|099|S|   A very serious allergic reaction to this drug is rare.||
0936|100|S|However, get medical help right away if you notice any symptoms||
0936|101|S|of a serious allergic reaction, including: rash, itching/swelling||
0936|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0936|103|S|breathing.||
0936|104|S|   This is not a complete list of possible side effects. If you||
0936|105|S|notice other effects not listed above, contact your doctor or||
0936|106|S|pharmacist.||
0936|107|S|   In the US -||
0936|108|S|   Call your doctor for medical advice about side effects. You||
0936|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0936|110|S|www.fda.gov/medwatch.||
0936|111|S|   In Canada - Call your doctor for medical advice about side||
0936|112|S|effects. You may report side effects to Health Canada at||
0936|113|S|1-866-234-2345.||
0936|114|B|||
0936|115|P|PRECAUTIONS:  Before using eculizumab, tell your doctor or||
0936|116|P|pharmacist if you are allergic to it; or to other eculizumab||
0936|117|P|products; or if you have any other allergies. This product may||
0936|118|P|contain inactive ingredients, which can cause allergic reactions||
0936|119|P|or other problems. Talk to your pharmacist for more details.||
0936|120|P|   Before using this medication, tell your doctor or pharmacist||
0936|121|P|your medical history, especially of: current/recent infection||
0936|122|P|(especially of meningitis).||
0936|123|P|   Before having surgery, tell your doctor or dentist about all||
0936|124|P|the products you use (including prescription drugs,||
0936|125|P|nonprescription drugs, and herbal products).||
0936|126|P|   Eculizumab can make you more likely to get certain infections||
0936|127|P|(such as gonorrhea). Talk to your doctor for more details.||
0936|128|P|   Tell your doctor your vaccine history and ask if you need to||
0936|129|P|get any vaccines before starting treatment with this medication.||
0936|130|P|Tell your health care professional that you are using eculizumab||
0936|131|P|before having any immunizations/vaccinations. Avoid contact with||
0936|132|P|people who have recently received live vaccines (such as flu||
0936|133|P|vaccine inhaled through the nose).||
0936|134|P|   During pregnancy, this medication should be used only when||
0936|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
0936|136|P|   It is unknown if this drug passes into breast milk. Consult||
0936|137|P|your doctor before breastfeeding.||
0936|138|B|||
0936|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0936|140|I|medications work or increase your risk for serious side effects.||
0936|141|I|This document does not contain all possible drug interactions.||
0936|142|I|Keep a list of all the products you use (including||
0936|143|I|prescription/nonprescription drugs and herbal products) and share||
0936|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
0936|145|I|the dosage of any medicines without your doctor's approval.||
0936|146|B|||
0936|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0936|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0936|149|O|poison control center right away. US residents can call||
0936|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0936|151|B|||
0936|152|N|NOTES:  Lab and/or medical tests (such as LDH levels, kidney||
0936|153|N|function, complete blood count, blood pressure) should be done||
0936|154|N|while you are using this medication and for 8 or 12 weeks after||
0936|155|N|stopping treatment. Keep all medical and lab appointments.||
0936|156|N|Consult your doctor for more details.||
0936|157|B|||
0936|158|D|MISSED DOSE:  It is important to get each dose of this medication||
0936|159|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0936|160|D|right away for a new dosing schedule.||
0936|161|B|||
0936|162|R|STORAGE:  Not applicable. This medication is given in a clinic||
0936|163|R|and will not be stored at home.||
0936|164|B|||
0936|165|M|MEDICAL ALERT:  Your condition can cause complications in a||
0936|166|M|medical emergency. For information about enrolling in MedicAlert,||
0936|167|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0936|168|B|||
0936|169|A|Information last revised April 2025.||
0936|170|A|Copyright(c) 2025 First Databank, Inc.||
0936|171|B|||
0938|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0938|002|Z|does NOT have all possible information about this product. This||
0938|003|Z|information does not assure that this product is safe, effective,||
0938|004|Z|or appropriate for you. This information is not individual||
0938|005|Z|medical advice and does not substitute for the advice of your||
0938|006|Z|health care professional. Always ask your health care||
0938|007|Z|professional for complete information about this product and your||
0938|008|Z|specific health needs.||
0938|009|B|||
0938|010|T|SITAGLIPTIN/METFORMIN - ORAL||
0938|011|F|(sit-a-GLIP-tin/met-FOR-min)||
0938|012|B|||
0938|013|C|COMMON BRAND NAME(S): Janumet, Zituvimet||
0938|014|B|||
0938|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
0938|016|W|cause a serious (sometimes fatal) condition called lactic||
0938|017|W|acidosis. Lactic acidosis is more likely if you are an older||
0938|018|W|adult, if you have kidney or liver disease, dehydration, heart||
0938|019|W|failure, heavy alcohol use, if you have surgery, if you have||
0938|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
0938|021|W|you are using certain drugs. For some conditions, your doctor may||
0938|022|W|tell you to stop taking this medication for a short time. Ask||
0938|023|W|your doctor or pharmacist for more details.||
0938|024|W|   Stop taking this medication and get medical help right away if||
0938|025|W|you have any symptoms of lactic acidosis, such as unusual||
0938|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
0938|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
0938|028|W|or stomach pain with nausea/vomiting/diarrhea.||
0938|029|B|||
0938|030|U|USES:  This combination medication is used with a proper diet and||
0938|031|U|exercise program and possibly with other medications to control||
0938|032|U|high blood sugar. It is used in patients with type 2 diabetes.||
0938|033|U|   This product contains 2 medications. Sitagliptin works by||
0938|034|U|increasing levels of natural substances called incretins.||
0938|035|U|Incretins help to control blood sugar by increasing insulin||
0938|036|U|release, especially after a meal. They also decrease the amount||
0938|037|U|of sugar your liver makes. Metformin works by helping to restore||
0938|038|U|your body's proper response to the insulin you naturally produce.||
0938|039|U|It also decreases the amount of sugar that your liver makes and||
0938|040|U|that your stomach/intestines absorb.||
0938|041|U|   Controlling high blood sugar helps prevent kidney damage,||
0938|042|U|blindness, nerve problems, loss of limbs, and sexual function||
0938|043|U|problems. Proper control of diabetes may also lessen your risk of||
0938|044|U|a heart attack or stroke.||
0938|045|B|||
0938|046|H|HOW TO USE:  Read the Medication Guide provided by your||
0938|047|H|pharmacist before you start using sitagliptin/metformin and each||
0938|048|H|time you get a refill. If you have any questions, ask your doctor||
0938|049|H|or pharmacist.||
0938|050|H|   Take this medication by mouth as directed by your doctor,||
0938|051|H|usually twice a day with meals. Drink plenty of fluids while||
0938|052|H|taking this medication unless otherwise directed by your doctor.||
0938|053|H|Do not break/cut the tablet before taking it. If you have trouble||
0938|054|H|swallowing the tablet whole, tell your doctor.||
0938|055|H|   The dosage is based on your medical condition, response to||
0938|056|H|treatment, and other medications you may be taking. Be sure to||
0938|057|H|tell your doctor and pharmacist about all the products you use||
0938|058|H|(including prescription drugs, nonprescription drugs, and herbal||
0938|059|H|products). To reduce your risk of side effects (such as upset||
0938|060|H|stomach), your doctor may direct you to start this medication at||
0938|061|H|a low dose and gradually increase your dose. Follow your doctor's||
0938|062|H|instructions carefully.||
0938|063|H|   Take this medication regularly in order to get the most||
0938|064|H|benefit from it. Remember to use it at the same times each day.||
0938|065|H|   If you are already taking another diabetes drug (such as||
0938|066|H|pioglitazone), follow your doctor's directions carefully for||
0938|067|H|stopping/continuing the old drug and starting this medication.||
0938|068|H|Carefully follow the medication treatment plan, meal plan, and||
0938|069|H|exercise program your doctor has recommended.||
0938|070|H|   Check your blood sugar regularly as directed by your doctor.||
0938|071|H|Keep track of the results, and share them with your doctor. Tell||
0938|072|H|your doctor if your blood sugar measurements are too high or too||
0938|073|H|low. Your dosage/treatment may need to be changed.||
0938|074|B|||
0938|075|S|SIDE EFFECTS:  See also Warning section.||
0938|076|S|   Nausea, vomiting, stomach upset, diarrhea, headache, weakness,||
0938|077|S|or a metallic taste in the mouth may occur. If any of these||
0938|078|S|effects last or get worse, tell your doctor or pharmacist||
0938|079|S|promptly. If stomach symptoms return later (after taking the same||
0938|080|S|dose for several days or weeks), tell your doctor right away.||
0938|081|S|Stomach symptoms that occur after the first days of your||
0938|082|S|treatment may be signs of lactic acidosis.||
0938|083|S|   Remember that this medication has been prescribed because your||
0938|084|S|doctor has judged that the benefit to you is greater than the||
0938|085|S|risk of side effects. Many people using this medication do not||
0938|086|S|have serious side effects.||
0938|087|S|   This medication does not usually cause low blood sugar||
0938|088|S|(hypoglycemia). Low blood sugar may occur if this drug is||
0938|089|S|prescribed with other diabetes medications, or if you do not get||
0938|090|S|enough calories from food, or if you do unusually heavy exercise.||
0938|091|S|Talk with your doctor or pharmacist about whether the dose of||
0938|092|S|your other diabetes medication(s) needs to be lowered. Symptoms||
0938|093|S|of low blood sugar include sudden sweating, shaking, fast||
0938|094|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
0938|095|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
0938|096|S|treat low blood sugar. If you don't have these reliable forms of||
0938|097|S|glucose, rapidly raise your blood sugar by eating a quick source||
0938|098|S|of sugar such as table sugar, honey, or candy, or drink fruit||
0938|099|S|juice or non-diet soda. Tell your doctor right away about the||
0938|100|S|reaction and the use of this product. To help prevent low blood||
0938|101|S|sugar, eat meals on a regular schedule, and do not skip meals.||
0938|102|S|Check with your doctor or pharmacist to find out what you should||
0938|103|S|do if you miss a meal.||
0938|104|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
0938|105|S|thirst/urination. If these symptoms occur, tell your doctor right||
0938|106|S|away. Your doctor may need to adjust your diabetes medication,||
0938|107|S|exercise program, or diet.||
0938|108|S|   Tell your doctor right away of any serious side effects,||
0938|109|S|including: signs of kidney problems (such as change in the amount||
0938|110|S|of urine), joint pain, unusual skin blisters, signs of heart||
0938|111|S|failure (such as shortness of breath, swelling ankles/feet,||
0938|112|S|unusual tiredness, unusual/sudden weight gain).||
0938|113|S|   Get medical help right away if you have any very serious side||
0938|114|S|effects, including: signs of pancreatitis (such as||
0938|115|S|nausea/vomiting that doesn't stop, loss of appetite, severe||
0938|116|S|stomach/abdominal/back pain), lactic acidosis (see Warning||
0938|117|S|section).||
0938|118|S|   A very serious allergic reaction to this drug is rare.||
0938|119|S|However, get medical help right away if you notice any symptoms||
0938|120|S|of a serious allergic reaction, including: rash, itching/swelling||
0938|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0938|122|S|breathing.||
0938|123|S|   This is not a complete list of possible side effects. If you||
0938|124|S|notice other effects not listed above, contact your doctor or||
0938|125|S|pharmacist.||
0938|126|S|   In the US -||
0938|127|S|   Call your doctor for medical advice about side effects. You||
0938|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0938|129|S|www.fda.gov/medwatch.||
0938|130|S|   In Canada - Call your doctor for medical advice about side||
0938|131|S|effects. You may report side effects to Health Canada at||
0938|132|S|1-866-234-2345.||
0938|133|B|||
0938|134|P|PRECAUTIONS:  See also Warning section.||
0938|135|P|   Before taking this medication, tell your doctor or pharmacist||
0938|136|P|if you are allergic to sitagliptin or metformin; or if you have||
0938|137|P|any other allergies. This product may contain inactive||
0938|138|P|ingredients, which can cause allergic reactions or other||
0938|139|P|problems. Talk to your pharmacist for more details.||
0938|140|P|   Before using this medication, tell your doctor or pharmacist||
0938|141|P|your medical history, especially of: severe breathing problems||
0938|142|P|(such as obstructive lung disease, severe asthma), blood problems||
0938|143|P|(such as anemia, vitamin B12 deficiency), kidney disease, liver||
0938|144|P|disease, disease of the pancreas (pancreatitis), stones in your||
0938|145|P|gallbladder (gallstones).||
0938|146|P|   Before having surgery or any X-ray/scanning procedure using||
0938|147|P|iodinated contrast, tell your doctor or dentist about all the||
0938|148|P|products you use (including prescription drugs, nonprescription||
0938|149|P|drugs, and herbal products). You may need to stop this medication||
0938|150|P|for a short time for the surgery/procedure. Ask your doctor or||
0938|151|P|dentist for instructions before your surgery/procedure.||
0938|152|P|   You may experience blurred vision, dizziness, or drowsiness||
0938|153|P|due to extremely low or high blood sugar. Do not drive, use||
0938|154|P|machinery, or do anything that needs alertness or clear vision||
0938|155|P|until you can do it safely.||
0938|156|P|   Limit alcohol while using this medication because it can||
0938|157|P|increase your risk of lactic acidosis and developing low blood||
0938|158|P|sugar.||
0938|159|P|   High fever, "water pills" (diuretics such as||
0938|160|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
0938|161|P|may cause dehydration and increase your risk of lactic acidosis.||
0938|162|P|Stop taking this medication and tell your doctor right away if||
0938|163|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
0938|164|P|fluids to prevent dehydration unless your doctor directs you||
0938|165|P|otherwise.||
0938|166|P|   It may be harder to control your blood sugar when your body is||
0938|167|P|stressed (such as due to fever, infection, injury, or surgery).||
0938|168|P|Consult your doctor because increased stress may require a change||
0938|169|P|in your treatment plan, medications, or blood sugar testing.||
0938|170|P|   Older adults may be at greater risk for side effects such as||
0938|171|P|low blood sugar or lactic acidosis.||
0938|172|P|   During pregnancy, this medication should be used only when||
0938|173|P|clearly needed. Discuss the risks and benefits with your doctor.||
0938|174|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
0938|175|P|your doctor for managing your blood sugar while pregnant. Your||
0938|176|P|doctor may change your diabetes treatment during your pregnancy||
0938|177|P|(such as diet and medications including insulin).||
0938|178|P|   Metformin can cause changes in the menstrual cycle (promote||
0938|179|P|ovulation) and increase the risk of becoming pregnant. Consult||
0938|180|P|your doctor or pharmacist about the use of reliable birth control||
0938|181|P|while using this medication.||
0938|182|P|   Metformin passes into breast milk in small amounts. It is||
0938|183|P|unknown if sitagliptin passes into breast milk. Consult your||
0938|184|P|doctor before breastfeeding.||
0938|185|B|||
0938|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0938|187|I|medications work or increase your risk for serious side effects.||
0938|188|I|This document does not contain all possible drug interactions.||
0938|189|I|Keep a list of all the products you use (including||
0938|190|I|prescription/nonprescription drugs and herbal products) and share||
0938|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
0938|192|I|the dosage of any medicines without your doctor's approval.||
0938|193|I|   Beta-blocker medications (such as metoprolol, propranolol,||
0938|194|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
0938|195|I|heartbeat you would usually feel when your blood sugar falls too||
0938|196|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
0938|197|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
0938|198|I|   Many drugs can affect your blood sugar, making it harder to||
0938|199|I|control. Before you start, stop, or change any medication, talk||
0938|200|I|with your doctor or pharmacist about how the medication may||
0938|201|I|affect your blood sugar. Check your blood sugar regularly as||
0938|202|I|directed and share the results with your doctor. Tell your doctor||
0938|203|I|right away if you have symptoms of high or low blood sugar. (See||
0938|204|I|also Side Effects section.) Your doctor may need to adjust your||
0938|205|I|diabetes medication, exercise program, or diet.||
0938|206|B|||
0938|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0938|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0938|209|O|poison control center right away. US residents can call||
0938|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0938|211|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
0938|212|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
0938|213|O|rapid breathing, slow/irregular heartbeat.||
0938|214|B|||
0938|215|N|NOTES:  Do not share this medication with others.||
0938|216|N|   Attend a diabetes education program to learn more about how to||
0938|217|N|manage your diabetes with medications, diet, exercise, and||
0938|218|N|regular medical exams.||
0938|219|N|   Learn the symptoms of high and low blood sugar and how to||
0938|220|N|treat low blood sugar. Check your blood sugar regularly as||
0938|221|N|directed.||
0938|222|N|   Lab and/or medical tests (such as kidney function, liver||
0938|223|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
0938|224|N|should be done before you start taking this medication and while||
0938|225|N|you are taking it. Keep all medical and lab appointments. Consult||
0938|226|N|your doctor for more details.||
0938|227|B|||
0938|228|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0938|229|D|remember. If it is near the time of the next dose, skip the||
0938|230|D|missed dose. Take your next dose at the regular time. Do not||
0938|231|D|double the dose to catch up.||
0938|232|B|||
0938|233|R|STORAGE:  Store at room temperature away from light and moisture.||
0938|234|R|Do not store in the bathroom. Some brands of this medication||
0938|235|R|should be stored in their original container and used within 3||
0938|236|R|months of opening the bottle. Check the product package or ask||
0938|237|R|your pharmacist about your specific brand. Keep all medications||
0938|238|R|away from children and pets.||
0938|239|R|   Do not flush medications down the toilet or pour them into a||
0938|240|R|drain unless instructed to do so. Properly discard this product||
0938|241|R|when it is expired or no longer needed. Consult your pharmacist||
0938|242|R|or local waste disposal company.||
0938|243|B|||
0938|244|M|MEDICAL ALERT:  Your condition can cause complications in a||
0938|245|M|medical emergency. For information about enrolling in MedicAlert,||
0938|246|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0938|247|B|||
0938|248|A|Information last revised November 2025.||
0938|249|A|Copyright(c) 2025 First Databank, Inc.||
0938|250|B|||
0941|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0941|002|Z|does NOT have all possible information about this product. This||
0941|003|Z|information does not assure that this product is safe, effective,||
0941|004|Z|or appropriate for you. This information is not individual||
0941|005|Z|medical advice and does not substitute for the advice of your||
0941|006|Z|health care professional. Always ask your health care||
0941|007|Z|professional for complete information about this product and your||
0941|008|Z|specific health needs.||
0941|009|B|||
0941|010|T|CLOXACILLIN - INJECTION||
0941|011|F|(klox-a-SIL-in)||
0941|012|B|||
0941|013|U|USES:  Cloxacillin is used to treat a wide variety of bacterial||
0941|014|U|infections. This medication is a type of penicillin antibiotic.||
0941|015|U|It works by stopping the growth of bacteria.||
0941|016|B|||
0941|017|H|HOW TO USE:  Depending on your specific product, this medication||
0941|018|H|is given by injection into a vein or muscle as directed by your||
0941|019|H|doctor, usually every 6 hours. The dosage is based on your||
0941|020|H|medical condition and response to treatment. Children's dosage is||
0941|021|H|also based on weight.||
0941|022|H|   If you are giving this medication to yourself at home, learn||
0941|023|H|all preparation and usage instructions from your health care||
0941|024|H|professional. Before using, check this product for particles or||
0941|025|H|discoloration. If either is present, do not use the liquid. Learn||
0941|026|H|how to store and discard medical supplies safely.||
0941|027|H|   For the best effect, use this antibiotic at evenly spaced||
0941|028|H|times. To help you remember, use this medication at the same||
0941|029|H|time(s) every day.||
0941|030|H|   Continue to use this medication for the full time prescribed,||
0941|031|H|even if symptoms disappear after a few days. Stopping the||
0941|032|H|medication too early may result in a return of the infection.||
0941|033|H|   Tell your doctor if your condition lasts or gets worse.||
0941|034|B|||
0941|035|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, diarrhea, and gas||
0941|036|S|may occur. If any of these effects last or get worse, tell your||
0941|037|S|doctor or pharmacist promptly.||
0941|038|S|   Remember that this medication has been prescribed because your||
0941|039|S|doctor has judged that the benefit to you is greater than the||
0941|040|S|risk of side effects. Many people using this medication do not||
0941|041|S|have serious side effects.||
0941|042|S|   Tell your doctor right away if you have any serious side||
0941|043|S|effects, including: nausea/vomiting that doesn't stop,||
0941|044|S|pain/redness/swelling at the injection site or of the arms/legs,||
0941|045|S|unusual tiredness, joint/muscle pain or swelling, easy||
0941|046|S|bruising/bleeding, signs of kidney problems (such as change in||
0941|047|S|the amount of urine, pink urine), dark urine, stomach/abdominal||
0941|048|S|pain, yellowing eyes/skin.||
0941|049|S|   This medication may rarely cause a severe intestinal condition||
0941|050|S|due to a bacteria called C. difficile. This condition may occur||
0941|051|S|during treatment or weeks to months after treatment has stopped.||
0941|052|S|Tell your doctor right away if you develop: diarrhea that doesn't||
0941|053|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
0941|054|S|stool.||
0941|055|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
0941|056|S|products because they may make symptoms worse.||
0941|057|S|   Use of this medication for prolonged or repeated periods may||
0941|058|S|result in oral thrush or a new vaginal yeast infection (oral or||
0941|059|S|vaginal fungal infection). Contact your doctor if you notice||
0941|060|S|white patches in your mouth, a change in vaginal discharge, or||
0941|061|S|other new symptoms.||
0941|062|S|   A very serious allergic reaction to this drug is rare.||
0941|063|S|However, get medical help right away if you notice any symptoms||
0941|064|S|of a serious allergic reaction, including: fever that doesn't go||
0941|065|S|away, new or worsening lymph node swelling, rash,||
0941|066|S|itching/swelling (especially of the face/tongue/throat), severe||
0941|067|S|dizziness, trouble breathing.||
0941|068|S|   This is not a complete list of possible side effects. If you||
0941|069|S|notice other effects not listed above, contact your doctor or||
0941|070|S|pharmacist.||
0941|071|S|   In the US -||
0941|072|S|   Call your doctor for medical advice about side effects. You||
0941|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0941|074|S|www.fda.gov/medwatch.||
0941|075|S|   In Canada - Call your doctor for medical advice about side||
0941|076|S|effects. You may report side effects to Health Canada at||
0941|077|S|1-866-234-2345.||
0941|078|B|||
0941|079|P|PRECAUTIONS:  Before using cloxacillin, tell your doctor or||
0941|080|P|pharmacist if you are allergic to it; or to other antibiotics||
0941|081|P|including penicillin-type medications (such as amoxicillin,||
0941|082|P|ampicillin, penicillin) or cephalosporins (such as cephalexin,||
0941|083|P|cefuroxime); or if you have any other allergies. This product may||
0941|084|P|contain inactive ingredients, which can cause allergic reactions||
0941|085|P|or other problems. Talk to your pharmacist for more details.||
0941|086|P|   Before using this medication, tell your doctor or pharmacist||
0941|087|P|your medical history, especially of: kidney problems.||
0941|088|P|   This medication contains sodium. Consult your doctor if you||
0941|089|P|eat a salt-restricted diet or if you have a condition that could||
0941|090|P|be worsened by an increase in salt intake (such as heart||
0941|091|P|failure).||
0941|092|P|   Cloxacillin may cause live bacterial vaccines (such as typhoid||
0941|093|P|vaccine) to not work well. Tell your health care professional||
0941|094|P|that you are using cloxacillin before having any||
0941|095|P|immunizations/vaccinations.||
0941|096|P|   Older adults may be more sensitive to the side effects of this||
0941|097|P|drug.||
0941|098|P|   Newborns may be more sensitive to the side effects of this||
0941|099|P|drug.||
0941|100|P|   During pregnancy, this medication should be used only when||
0941|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
0941|102|P|   This drug passes into breast milk. Consult your doctor before||
0941|103|P|breastfeeding.||
0941|104|B|||
0941|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0941|106|I|medications work or increase your risk for serious side effects.||
0941|107|I|This document does not contain all possible drug interactions.||
0941|108|I|Keep a list of all the products you use (including||
0941|109|I|prescription/nonprescription drugs and herbal products) and share||
0941|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
0941|111|I|the dosage of any medicines without your doctor's approval.||
0941|112|I|   Some products that may interact with this drug include:||
0941|113|I|methotrexate, tetracyclines, warfarin.||
0941|114|I|   This medication may interfere with certain lab tests (such as||
0941|115|I|certain diabetic urine tests), possibly causing false test||
0941|116|I|results. Make sure lab personnel and all your doctors know you||
0941|117|I|use this drug.||
0941|118|B|||
0941|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0941|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0941|121|O|poison control center right away. US residents can call||
0941|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0941|123|O|Symptoms of overdose may include: mental/mood changes (such as||
0941|124|O|confusion), seizures.||
0941|125|B|||
0941|126|N|NOTES:  If you are using this drug for a long time, lab and/or||
0941|127|N|medical tests (such as kidney/liver function, complete blood||
0941|128|N|counts) should be done while you are using this medication. Keep||
0941|129|N|all medical and lab appointments. Consult your doctor for more||
0941|130|N|details.||
0941|131|B|||
0941|132|D|MISSED DOSE:  It is important to get each dose of this medication||
0941|133|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0941|134|D|right away for a new dosing schedule. Do not double the dose to||
0941|135|D|catch up.||
0941|136|B|||
0941|137|R|STORAGE:  Consult the product instructions and your pharmacist||
0941|138|R|for storage details. Keep all medications away from children and||
0941|139|R|pets.||
0941|140|R|   Do not flush medications down the toilet or pour them into a||
0941|141|R|drain unless instructed to do so. Properly discard this product||
0941|142|R|when it is expired or no longer needed. Consult your pharmacist||
0941|143|R|or local waste disposal company.||
0941|144|B|||
0941|145|A|Information last revised December 2024.||
0941|146|A|Copyright(c) 2025 First Databank, Inc.||
0941|147|B|||
0942|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0942|002|Z|does NOT have all possible information about this product. This||
0942|003|Z|information does not assure that this product is safe, effective,||
0942|004|Z|or appropriate for you. This information is not individual||
0942|005|Z|medical advice and does not substitute for the advice of your||
0942|006|Z|health care professional. Always ask your health care||
0942|007|Z|professional for complete information about this product and your||
0942|008|Z|specific health needs.||
0942|009|B|||
0942|010|T|RETAPAMULIN - TOPICAL||
0942|011|F|(RE-te-PAM-ue-lin)||
0942|012|B|||
0942|013|C|COMMON BRAND NAME(S): Altabax||
0942|014|B|||
0942|015|U|USES:  Retapamulin is used to treat a certain skin infection||
0942|016|U|(impetigo) caused by bacteria. It is an antibiotic that works by||
0942|017|U|stopping the growth of certain bacteria (Staphylococcus and||
0942|018|U|Streptococcus) on the skin.||
0942|019|B|||
0942|020|H|HOW TO USE:  Use this medication on the skin only. Clean and dry||
0942|021|H|the affected area first. Then apply a small amount of ointment to||
0942|022|H|the affected area as directed by your doctor, usually 2 times a||
0942|023|H|day for 5 days. Wash your hands after applying unless you are||
0942|024|H|treating an area on the hands.||
0942|025|H|   Do not use this medication around the eyes, nose, mouth, or||
0942|026|H|vaginal area, or on large areas of skin, unless otherwise||
0942|027|H|directed by your doctor. You may cover the treated area with a||
0942|028|H|bandage/gauze. This may help prevent your child from accidentally||
0942|029|H|getting the medication in their eyes, nose, or mouth.||
0942|030|H|   Use this medication regularly in order to get the most benefit||
0942|031|H|from it. Continue to use this medication for the full time||
0942|032|H|prescribed, even if symptoms disappear after a few days. Stopping||
0942|033|H|the medication too early may result in a return of the infection.||
0942|034|H|   You should see some improvement (healed/dry sores, decreased||
0942|035|H|redness) in 3 to 4 days. Tell your doctor if your condition does||
0942|036|H|not get better in 3 to 4 days.||
0942|037|B|||
0942|038|S|SIDE EFFECTS:  Mild burning, stinging, or itching may occur. If||
0942|039|S|any of these effects last or get worse, tell your doctor or||
0942|040|S|pharmacist promptly.||
0942|041|S|   Remember that this medication has been prescribed because your||
0942|042|S|doctor has judged that the benefit to you is greater than the||
0942|043|S|risk of side effects. Many people using this medication do not||
0942|044|S|have serious side effects.||
0942|045|S|   Tell your doctor right away if you have any serious side||
0942|046|S|effects, including: blistering/swelling/oozing skin.||
0942|047|S|   Use of this medication for prolonged or repeated periods may||
0942|048|S|result in a new infection (such as a fungal infection). Contact||
0942|049|S|your doctor if you notice signs of a new infection (such as||
0942|050|S|new/worsening sores, fever).||
0942|051|S|   A very serious allergic reaction to this drug is rare.||
0942|052|S|However, get medical help right away if you notice any symptoms||
0942|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0942|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0942|055|S|breathing.||
0942|056|S|   This is not a complete list of possible side effects. If you||
0942|057|S|notice other effects not listed above, contact your doctor or||
0942|058|S|pharmacist.||
0942|059|S|   In the US -||
0942|060|S|   Call your doctor for medical advice about side effects. You||
0942|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0942|062|S|www.fda.gov/medwatch.||
0942|063|S|   In Canada - Call your doctor for medical advice about side||
0942|064|S|effects. You may report side effects to Health Canada at||
0942|065|S|1-866-234-2345.||
0942|066|B|||
0942|067|P|PRECAUTIONS:  Before using retapamulin, tell the doctor or||
0942|068|P|pharmacist if you are allergic to it; or if you have any other||
0942|069|P|allergies. This product may contain inactive ingredients, which||
0942|070|P|can cause allergic reactions or other problems. Talk to your||
0942|071|P|pharmacist for more details.||
0942|072|P|   Before using this medication, tell the doctor or pharmacist||
0942|073|P|your medical history.||
0942|074|P|   Before having surgery, tell your doctor or dentist about all||
0942|075|P|the products you use (including prescription drugs,||
0942|076|P|nonprescription drugs, and herbal products).||
0942|077|P|   During pregnancy, this medication should be used only when||
0942|078|P|clearly needed. Discuss the risks and benefits with your doctor.||
0942|079|P|   It is unknown if this medication passes into breast milk.||
0942|080|P|Consult your doctor before breastfeeding.||
0942|081|B|||
0942|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0942|083|I|medications work or increase your risk for serious side effects.||
0942|084|I|This document does not contain all possible drug interactions.||
0942|085|I|Keep a list of all the products you use (including||
0942|086|I|prescription/nonprescription drugs and herbal products) and share||
0942|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
0942|088|I|the dosage of any medicines without your doctor's approval.||
0942|089|B|||
0942|090|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0942|091|O|has overdosed and has serious symptoms such as passing out or||
0942|092|O|trouble breathing, call 911. Otherwise, call a poison control||
0942|093|O|center right away. US residents can call 1-800-222-1222. Canada||
0942|094|O|residents can call 1-844-764-7669.||
0942|095|B|||
0942|096|N|NOTES:  Do not share this medication with others.||
0942|097|N|   This medication has been prescribed for your current condition||
0942|098|N|only. Do not use it later for another infection unless your||
0942|099|N|doctor tells you to.||
0942|100|B|||
0942|101|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0942|102|D|If it is near the time of the next dose, skip the missed dose.||
0942|103|D|Use your next dose at the regular time. Do not double the dose to||
0942|104|D|catch up.||
0942|105|B|||
0942|106|R|STORAGE:  Store at room temperature. Keep all medications away||
0942|107|R|from children and pets.||
0942|108|R|   Do not flush medications down the toilet or pour them into a||
0942|109|R|drain unless instructed to do so. Properly discard this product||
0942|110|R|when it is expired or no longer needed. Consult your pharmacist||
0942|111|R|or local waste disposal company.||
0942|112|B|||
0942|113|A|Information last revised November 2024.||
0942|114|A|Copyright(c) 2025 First Databank, Inc.||
0942|115|B|||
0943|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0943|002|Z|does NOT have all possible information about this product. This||
0943|003|Z|information does not assure that this product is safe, effective,||
0943|004|Z|or appropriate for you. This information is not individual||
0943|005|Z|medical advice and does not substitute for the advice of your||
0943|006|Z|health care professional. Always ask your health care||
0943|007|Z|professional for complete information about this product and your||
0943|008|Z|specific health needs.||
0943|009|B|||
0943|010|T|BUDESONIDE ENEMA - RECTAL||
0943|011|F|(bue-DES-oh-nide)||
0943|012|B|||
0943|013|U|USES:  This medication is used to treat symptoms of inflammatory||
0943|014|U|bowel disease (ulcerative colitis). Budesonide does not cure this||
0943|015|U|condition, but it may help relieve symptoms such as abdominal||
0943|016|U|pain, diarrhea, and bloody stools. Using this medication as an||
0943|017|U|enema allows it to work directly on the bowel and rectum.||
0943|018|U|Budesonide is a corticosteroid that works by decreasing swelling||
0943|019|U|(inflammation).||
0943|020|B|||
0943|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0943|022|H|from your pharmacist before you start using budesonide and each||
0943|023|H|time you get a refill. If you have any questions, ask your doctor||
0943|024|H|or pharmacist.||
0943|025|H|   Use this medication as an enema in the rectum as directed by||
0943|026|H|your doctor, usually once daily in the evening at bedtime.||
0943|027|H|Dissolve the tablet in the enema solution provided, shaking well||
0943|028|H|for at least 10 seconds. The mixed solution should be pale||
0943|029|H|yellow. After mixing, use the solution right away. Do not prepare||
0943|030|H|the solution in advance. Do not swallow the tablet.||
0943|031|H|   For best results, use after a bowel movement. Lie on your left||
0943|032|H|side with the left knee bent toward the chest. Gently insert the||
0943|033|H|nozzle into the rectum. Gently but firmly squeeze the bottle so||
0943|034|H|that all of the drug flows into the rectum. Straighten your leg,||
0943|035|H|roll over on your stomach, and stay in that position for at least||
0943|036|H|5 minutes. Keep the medicine in your rectum overnight or for as||
0943|037|H|long as possible.||
0943|038|H|   The dosage and length of treatment are based on your medical||
0943|039|H|condition and response to treatment.||
0943|040|H|   Use this medication regularly to get the most benefit from it.||
0943|041|H|To help you remember, use it at the same time each day.||
0943|042|H|   Do not increase your dose or use this drug more often or for||
0943|043|H|longer than prescribed. Your condition will not improve any||
0943|044|H|faster, and your risk of side effects will increase.||
0943|045|H|   Do not stop using this medication without consulting your||
0943|046|H|doctor. Some conditions may become worse when the drug is||
0943|047|H|suddenly stopped. Also, you may experience symptoms such as||
0943|048|H|extreme tiredness, muscle/joint pain, headache, weakness, or||
0943|049|H|nausea. To prevent these symptoms while you are stopping||
0943|050|H|treatment with this drug, your doctor may reduce your dose||
0943|051|H|gradually. Consult your doctor or pharmacist for more details.||
0943|052|H|Report any new or worsening symptoms right away.||
0943|053|H|   Tell your doctor if your condition lasts or gets worse.||
0943|054|B|||
0943|055|S|SIDE EFFECTS:  See also Precautions section.||
0943|056|S|   Gas, nausea, diarrhea, or trouble sleeping may occur. If any||
0943|057|S|of these effects last or get worse, tell your doctor or||
0943|058|S|pharmacist promptly.||
0943|059|S|   Remember that this medication has been prescribed because your||
0943|060|S|doctor has judged that the benefit to you is greater than the||
0943|061|S|risk of side effects. Many people using this medication do not||
0943|062|S|have serious side effects.||
0943|063|S|   Because this medication is used as an enema, serious side||
0943|064|S|effects are less likely than with corticosteroids taken by mouth.||
0943|065|S|Tell your doctor right away if any of these rare but very serious||
0943|066|S|side effects occur: headache that is severe or doesn't go away,||
0943|067|S|mental/mood changes (such as depression, mood swings, agitation,||
0943|068|S|confusion), unusual/extreme tiredness, weight loss, swelling||
0943|069|S|ankles/feet, bone pain, vision problems, increased||
0943|070|S|thirst/urination, symptoms of stomach/intestinal bleeding (such||
0943|071|S|as stomach/abdominal pain, black/tarry stools, vomit that looks||
0943|072|S|like coffee grounds).||
0943|073|S|   This medication may lower your ability to fight infections.||
0943|074|S|This may make you more likely to get a serious (rarely fatal)||
0943|075|S|infection or make any infection you have worse. Tell your doctor||
0943|076|S|right away if you have any signs of infection (such as sore||
0943|077|S|throat that doesn't go away, fever, chills).||
0943|078|S|   A very serious allergic reaction to this drug is rare.||
0943|079|S|However, get medical help right away if you notice any symptoms||
0943|080|S|of a serious allergic reaction, including: rash, itching/swelling||
0943|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0943|082|S|breathing.||
0943|083|S|   This is not a complete list of possible side effects. If you||
0943|084|S|notice other effects not listed above, contact your doctor or||
0943|085|S|pharmacist.||
0943|086|S|   In the US -||
0943|087|S|   Call your doctor for medical advice about side effects. You||
0943|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0943|089|S|www.fda.gov/medwatch.||
0943|090|S|   In Canada - Call your doctor for medical advice about side||
0943|091|S|effects. You may report side effects to Health Canada at||
0943|092|S|1-866-234-2345.||
0943|093|B|||
0943|094|P|PRECAUTIONS:  Before using budesonide, tell your doctor if you||
0943|095|P|are allergic to it; or if you have any other allergies. This||
0943|096|P|product may contain inactive ingredients, which can cause||
0943|097|P|allergic reactions or other problems. Talk to your pharmacist for||
0943|098|P|more details.||
0943|099|P|   Before using this medication, tell your doctor or pharmacist||
0943|100|P|your medical history, especially of: stomach/intestinal problems||
0943|101|P|(such as blockage, perforation, recent intestinal surgeries,||
0943|102|P|ulcer, diverticulitis, infections including abscesses and||
0943|103|P|peritonitis), current/past infections (such as tuberculosis,||
0943|104|P|ocular herpes simplex, fungal), mental/mood disorders (such as||
0943|105|P|depression, psychosis), diabetes, certain eye problems||
0943|106|P|(cataracts, glaucoma), high blood pressure, liver disease, bone||
0943|107|P|loss (osteoporosis), thyroid problems.||
0943|108|P|   Using corticosteroid medications for a long time can make it||
0943|109|P|more difficult for your body to respond to physical stress.||
0943|110|P|Before having surgery or emergency treatment, or if you get a||
0943|111|P|serious illness/injury, tell your doctor or dentist that you are||
0943|112|P|using this medication or have used this medication within the||
0943|113|P|past 12 months. Tell your doctor right away if you develop||
0943|114|P|unusual/extreme tiredness or weight loss. If you will be using||
0943|115|P|this medication for a long time, carry a warning card or medical||
0943|116|P|ID bracelet that identifies your use of this medication.||
0943|117|P|   Budesonide may mask signs of infection. It can make you more||
0943|118|P|likely to get infections or may make current infections worse.||
0943|119|P|Stay away from anyone who has an infection that may easily spread||
0943|120|P|(such as chickenpox, COVID-19, measles, flu). Talk to your doctor||
0943|121|P|if you have been exposed to an infection or for more details.||
0943|122|P|   Tell your health care professional that you are using||
0943|123|P|budesonide before having any immunizations/vaccinations. Avoid||
0943|124|P|contact with people who have recently received live vaccines||
0943|125|P|(such as flu vaccine inhaled through the nose).||
0943|126|P|   Older adults may be more sensitive to the side effects of this||
0943|127|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
0943|128|P|mental/mood changes (such as confusion).||
0943|129|P|   This medication may slow down a child's growth if used for a||
0943|130|P|long time. Consult the doctor or pharmacist for more details. See||
0943|131|P|the doctor regularly so your child's height and growth can be||
0943|132|P|checked.||
0943|133|P|   During pregnancy, this medication should be used only when||
0943|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
0943|135|P|Babies born to mothers who have used corticosteroids for a long||
0943|136|P|time may develop hormone problems. Tell your doctor right away if||
0943|137|P|you notice symptoms such as nausea/vomiting that doesn't stop,||
0943|138|P|severe diarrhea, or weakness in your newborn.||
0943|139|P|   This medication passes into breast milk. Consult your doctor||
0943|140|P|before breastfeeding.||
0943|141|B|||
0943|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0943|143|I|medications work or increase your risk for serious side effects.||
0943|144|I|This document does not contain all possible drug interactions.||
0943|145|I|Keep a list of all the products you use (including||
0943|146|I|prescription/nonprescription drugs and herbal products) and share||
0943|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
0943|148|I|the dosage of any medicines without your doctor's approval.||
0943|149|I|   Some products that may interact with this drug include:||
0943|150|I|aldesleukin, desmopressin, mifepristone, drugs that can cause||
0943|151|I|bleeding/bruising (including antiplatelet drugs such as||
0943|152|I|clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs||
0943|153|I|such as aspirin/celecoxib/ibuprofen).||
0943|154|I|   If your doctor has told you to take low-dose aspirin to||
0943|155|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
0943|156|I|you should keep taking the aspirin unless your doctor tells you||
0943|157|I|not to. Ask your doctor or pharmacist for more details.||
0943|158|B|||
0943|159|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0943|160|O|has overdosed and has serious symptoms such as passing out or||
0943|161|O|trouble breathing, call 911. Otherwise, call a poison control||
0943|162|O|center right away. US residents can call 1-800-222-1222. Canada||
0943|163|O|residents can call 1-844-764-7669.||
0943|164|B|||
0943|165|N|NOTES:  Do not share this medication with others.||
0943|166|N|   This medication may cause bone loss (osteoporosis) when used||
0943|167|N|for a long time. Lifestyle changes that may help reduce the risk||
0943|168|N|of bone problems include doing weight-bearing exercise, stopping||
0943|169|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
0943|170|N|D. Talk to your doctor for more details.||
0943|171|B|||
0943|172|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0943|173|D|If it is near the time of the next dose, skip the missed dose.||
0943|174|D|Use your next dose at the regular time. Do not double the dose to||
0943|175|D|catch up.||
0943|176|B|||
0943|177|R|STORAGE:  Store the tablet and unmixed solution at room||
0943|178|R|temperature. Keep all medications away from children and pets.||
0943|179|R|   Do not flush medications down the toilet or pour them into a||
0943|180|R|drain unless instructed to do so. Properly discard this product||
0943|181|R|when it is expired or no longer needed. Consult your pharmacist||
0943|182|R|or local waste disposal company.||
0943|183|B|||
0943|184|A|Information last revised September 2025.||
0943|185|A|Copyright(c) 2025 First Databank, Inc.||
0943|186|B|||
0944|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0944|002|Z|does NOT have all possible information about this product. This||
0944|003|Z|information does not assure that this product is safe, effective,||
0944|004|Z|or appropriate for you. This information is not individual||
0944|005|Z|medical advice and does not substitute for the advice of your||
0944|006|Z|health care professional. Always ask your health care||
0944|007|Z|professional for complete information about this product and your||
0944|008|Z|specific health needs.||
0944|009|B|||
0944|010|T|PHENYLEPHRINE - ORAL||
0944|011|F|(FEN-il-EF-rin)||
0944|012|B|||
0944|013|C|COMMON BRAND NAME(S): Sudafed PE, Sudogest PE||
0944|014|B|||
0944|015|U|USES:  Phenylephrine is used for the temporary relief of stuffy||
0944|016|U|nose, sinus, and ear symptoms caused by the common cold, flu,||
0944|017|U|allergies, or other breathing illnesses (such as sinusitis,||
0944|018|U|bronchitis). This medication works by decreasing swelling in the||
0944|019|U|nose and ears, thereby lessening discomfort and making it easier||
0944|020|U|to breathe.||
0944|021|U|   Cough-and-cold products have not been shown to be safe or||
0944|022|U|effective in children younger than 6 years. Do not use this||
0944|023|U|product to treat cold symptoms in children younger than 6 years||
0944|024|U|unless specifically directed by the doctor. Some products (such||
0944|025|U|as long-acting tablets/capsules) are not recommended for use in||
0944|026|U|children younger than 12 years. Ask your doctor or pharmacist for||
0944|027|U|more details about using your product safely.||
0944|028|U|   These products do not cure or shorten the length of the common||
0944|029|U|cold and may cause serious side effects. To decrease the risk for||
0944|030|U|serious side effects, carefully follow all dosage directions. Do||
0944|031|U|not use this product to make a child sleepy. Do not give other||
0944|032|U|cough-and-cold medication that might contain the same or similar||
0944|033|U|ingredients (see also Drug Interactions section). Ask the doctor||
0944|034|U|or pharmacist about other ways to relieve cough and cold symptoms||
0944|035|U|(such as drinking enough fluids, using a humidifier or saline||
0944|036|U|nose drops/spray).||
0944|037|B|||
0944|038|H|HOW TO USE:  If you are using the over-the-counter product, read||
0944|039|H|and follow all directions on the product package before taking||
0944|040|H|this medication.||
0944|041|H|   Take this medication by mouth with or without food or as||
0944|042|H|directed by your doctor. Taking it with food may decrease stomach||
0944|043|H|upset.||
0944|044|H|   If you are using the liquid, carefully measure your prescribed||
0944|045|H|dose using a medication-measuring device or spoon. Do not use a||
0944|046|H|household spoon because you may not get the correct dose.||
0944|047|H|   If you are using chewable tablets, chew each tablet thoroughly||
0944|048|H|before swallowing.||
0944|049|H|   If you are using a product made to dissolve in the mouth||
0944|050|H|(tablets or strips), dry your hands before handling the||
0944|051|H|medication. Place each dose on the tongue and allow to dissolve||
0944|052|H|completely, then swallow it with saliva or with water.||
0944|053|H|   The dosage is based on your age. Do not increase your dose or||
0944|054|H|take this medication more often than directed without your||
0944|055|H|doctor's approval. Improper use (abuse) of this medication may||
0944|056|H|result in serious harm (such as hallucinations, seizure, death).||
0944|057|H|   Tell your doctor if your symptoms get worse or do not get||
0944|058|H|better after 7 days, or if you have a fever or chills. If you||
0944|059|H|think you may have a serious medical problem, get medical help||
0944|060|H|right away.||
0944|061|B|||
0944|062|S|SIDE EFFECTS:  Mild upset stomach, trouble sleeping, dizziness,||
0944|063|S|lightheadedness, headache, nervousness, shaking, or fast||
0944|064|S|heartbeat may occur. If any of these effects last or get worse,||
0944|065|S|tell your doctor or pharmacist promptly.||
0944|066|S|   This product may reduce blood flow to your hands or feet,||
0944|067|S|causing them to feel cold. Smoking may worsen this effect. Dress||
0944|068|S|warmly and avoid tobacco use.||
0944|069|S|   If your doctor has directed you to use this medication,||
0944|070|S|remember that your doctor has judged that the benefit to you is||
0944|071|S|greater than the risk of side effects. Many people using this||
0944|072|S|medication do not have serious side effects.||
0944|073|S|   This medication may raise your blood pressure. Check your||
0944|074|S|blood pressure regularly and tell your doctor if the results are||
0944|075|S|high.||
0944|076|S|   Tell your doctor right away if you have any serious side||
0944|077|S|effects, including: fast/irregular heartbeat, severe/uncontrolled||
0944|078|S|shaking, difficulty urinating, seizures, mental/mood changes||
0944|079|S|(such as anxiety, panic, confusion, unusual thoughts/behavior).||
0944|080|S|   A very serious allergic reaction to this drug is rare.||
0944|081|S|However, get medical help right away if you notice any symptoms||
0944|082|S|of a serious allergic reaction, including: rash, itching/swelling||
0944|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0944|084|S|breathing.||
0944|085|S|   This is not a complete list of possible side effects. If you||
0944|086|S|notice other effects not listed above, contact your doctor or||
0944|087|S|pharmacist.||
0944|088|S|   In the US -||
0944|089|S|   Call your doctor for medical advice about side effects. You||
0944|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0944|091|S|www.fda.gov/medwatch.||
0944|092|S|   In Canada - Call your doctor for medical advice about side||
0944|093|S|effects. You may report side effects to Health Canada at||
0944|094|S|1-866-234-2345.||
0944|095|B|||
0944|096|P|PRECAUTIONS:  Before taking phenylephrine, tell your doctor or||
0944|097|P|pharmacist if you are allergic to it; or to||
0944|098|P|pseudoephedrine/ephedrine; or if you have any other allergies.||
0944|099|P|This product may contain inactive ingredients, which can cause||
0944|100|P|allergic reactions or other problems. Talk to your pharmacist for||
0944|101|P|more details.||
0944|102|P|   Before using this medication, tell your doctor or pharmacist||
0944|103|P|your medical history, especially of: blood vessel problems (such||
0944|104|P|as Raynaud's disease, low blood flow to the brain/legs/hands),||
0944|105|P|high blood pressure, diabetes, glaucoma, heart disease (such as||
0944|106|P|angina, fast/irregular heartbeat, heart failure), mental/mood||
0944|107|P|disorders (such as anxiety, bipolar disorder, mania), difficulty||
0944|108|P|sleeping, seizure disorder, overactive thyroid (hyperthyroidism),||
0944|109|P|trouble urinating (such as due to enlarged prostate).||
0944|110|P|   This drug may make you dizzy or lightheaded. Alcohol or||
0944|111|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
0944|112|P|machinery, or do anything that needs alertness until you can do||
0944|113|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0944|114|P|are using marijuana (cannabis).||
0944|115|P|   Liquid products, chewable tablets, or dissolving||
0944|116|P|tablets/strips may contain sugar or aspartame. Liquid products||
0944|117|P|may also contain alcohol. Caution is advised if you have||
0944|118|P|diabetes, alcohol dependence, liver disease, phenylketonuria||
0944|119|P|(PKU), or any other condition that requires you to limit/avoid||
0944|120|P|these substances in your diet. Ask your doctor or pharmacist||
0944|121|P|about using this product safely.||
0944|122|P|   Before having surgery, tell your doctor or dentist about all||
0944|123|P|the products you use (including prescription drugs,||
0944|124|P|nonprescription drugs, and herbal products).||
0944|125|P|   Older adults may be more sensitive to the side effects of this||
0944|126|P|drug, especially fast/irregular heartbeat, dizziness, problems||
0944|127|P|urinating, trouble sleeping, or confusion.||
0944|128|P|   During pregnancy, this medication should be used only when||
0944|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
0944|130|P|   This medication passes into breast milk. Consult your doctor||
0944|131|P|before breastfeeding.||
0944|132|B|||
0944|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0944|134|I|medications work or increase your risk for serious side effects.||
0944|135|I|This document does not contain all possible drug interactions.||
0944|136|I|Keep a list of all the products you use (including||
0944|137|I|prescription/nonprescription drugs and herbal products) and share||
0944|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
0944|139|I|the dosage of any medicines without your doctor's approval.||
0944|140|I|   Taking MAO inhibitors with this medication may cause a serious||
0944|141|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0944|142|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0944|143|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0944|144|I|selegiline, tranylcypromine) during treatment with this||
0944|145|I|medication. Most MAO inhibitors should also not be taken for two||
0944|146|I|weeks before treatment with this medication. Ask your doctor when||
0944|147|I|to start or stop taking this medication.||
0944|148|I|   Check the labels on all your medicines (such as allergy or||
0944|149|I|cough-and-cold products) because they may contain similar||
0944|150|I|ingredients (decongestants such as pseudoephedrine). Ask your||
0944|151|I|pharmacist about using those products safely.||
0944|152|B|||
0944|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0944|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0944|155|O|poison control center right away. US residents can call||
0944|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0944|157|O|Symptoms of overdose may include: severe dizziness/fainting,||
0944|158|O|hallucinations, fast/irregular heartbeat, slow/shallow breathing,||
0944|159|O|vomiting, seizures.||
0944|160|B|||
0944|161|N|NOTES:  If this product has been prescribed, do not share this||
0944|162|N|medication with others.||
0944|163|B|||
0944|164|D|MISSED DOSE:  If you are taking this medication on a prescribed||
0944|165|D|schedule and miss a dose, take it as soon as you remember. If it||
0944|166|D|is near the time of the next dose, skip the missed dose. Take||
0944|167|D|your next dose at the regular time. Do not double the dose to||
0944|168|D|catch up.||
0944|169|B|||
0944|170|R|STORAGE:  Store at room temperature away from light and moisture.||
0944|171|R|Do not store in the bathroom. Keep all medications away from||
0944|172|R|children and pets.||
0944|173|R|   Do not flush medications down the toilet or pour them into a||
0944|174|R|drain unless instructed to do so. Properly discard this product||
0944|175|R|when it is expired or no longer needed. Consult your pharmacist||
0944|176|R|or local waste disposal company.||
0944|177|B|||
0944|178|A|Information last revised July 2025.||
0944|179|A|Copyright(c) 2025 First Databank, Inc.||
0944|180|B|||
0945|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0945|002|Z|does NOT have all possible information about this product. This||
0945|003|Z|information does not assure that this product is safe, effective,||
0945|004|Z|or appropriate for you. This information is not individual||
0945|005|Z|medical advice and does not substitute for the advice of your||
0945|006|Z|health care professional. Always ask your health care||
0945|007|Z|professional for complete information about this product and your||
0945|008|Z|specific health needs.||
0945|009|B|||
0945|010|T|LISDEXAMFETAMINE - ORAL||
0945|011|F|(lis-DEX-am-FET-a-meen)||
0945|012|B|||
0945|013|C|COMMON BRAND NAME(S): Vyvanse||
0945|014|B|||
0945|015|W|WARNING:  Misuse or abuse of amphetamines may cause serious||
0945|016|W|(possibly fatal) heart and blood pressure problems.||
0945|017|W|Amphetamine-type medications can be habit-forming. Use only as||
0945|018|W|directed. If you use this drug for a long time, you may become||
0945|019|W|dependent on it and may have withdrawal symptoms after stopping||
0945|020|W|the drug. Consult your doctor or pharmacist for more details.||
0945|021|W|(See also How to Use section.)||
0945|022|B|||
0945|023|U|USES:  Lisdexamfetamine is used to treat attention deficit||
0945|024|U|hyperactivity disorder (ADHD) as part of a total treatment plan,||
0945|025|U|including psychological, social, and other treatments. It may||
0945|026|U|help to increase the ability to pay attention, stay focused, and||
0945|027|U|stop fidgeting. Lisdexamfetamine may also be used to treat binge||
0945|028|U|eating disorder (BED). It may help to reduce the number of binge||
0945|029|U|eating days.||
0945|030|U|   This medication is a stimulant. It is thought to work by||
0945|031|U|restoring the balance of certain natural chemicals||
0945|032|U|(neurotransmitters) in the brain.||
0945|033|U|   This medication is not recommended for use for weight loss due||
0945|034|U|to the risk of serious side effects.||
0945|035|B|||
0945|036|H|HOW TO USE:  Read the Medication Guide provided by your||
0945|037|H|pharmacist before you start taking lisdexamfetamine and each time||
0945|038|H|you get a refill. If you have any questions, ask your doctor or||
0945|039|H|pharmacist.||
0945|040|H|   Take this medication with or without food as directed by your||
0945|041|H|doctor, usually once daily in the morning. Do not take this||
0945|042|H|medication in the afternoon or evening because it may cause you||
0945|043|H|to have trouble sleeping. The dosage is based on your medical||
0945|044|H|condition and response to treatment. Your doctor may adjust your||
0945|045|H|dose to find the dose that is best for you. Follow your doctor's||
0945|046|H|instructions carefully.||
0945|047|H|   If you are taking the chewable tablet, chew the tablet||
0945|048|H|thoroughly and then swallow.||
0945|049|H|   If you are taking the capsule form of this medication, swallow||
0945|050|H|the capsule whole. However, if you have trouble swallowing the||
0945|051|H|capsule, you may open the capsule and pour all of its contents||
0945|052|H|(powder) in a glass of water or orange juice or mix it in yogurt.||
0945|053|H|Use a spoon to break apart any powder that is stuck together.||
0945|054|H|Stir well until the contents dissolve completely. Drink or eat||
0945|055|H|the mixture right away. Do not prepare a supply in advance. It is||
0945|056|H|normal to see a filmy coating on the inside of your glass or||
0945|057|H|container after you drink or eat all of the medicine.||
0945|058|H|   Use this medication regularly to get the most benefit from it.||
0945|059|H|To help you remember, take it at the same time each day.||
0945|060|H|   During treatment, your doctor may occasionally recommend||
0945|061|H|stopping the medication for a short time to see whether there are||
0945|062|H|any changes in your behavior and whether the medication is still||
0945|063|H|needed.||
0945|064|H|   If you suddenly stop using this medication, you may have||
0945|065|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
0945|066|H|mental/mood changes such as depression). To help prevent||
0945|067|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0945|068|H|more likely if you have used lisdexamfetamine for a long time or||
0945|069|H|in high doses. Tell your doctor or pharmacist right away if you||
0945|070|H|have withdrawal.||
0945|071|H|   Though it helps many people, this medication may sometimes||
0945|072|H|cause addiction. This risk may be higher if you have a substance||
0945|073|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0945|074|H|Do not increase your dose, take it more often, or use it for a||
0945|075|H|longer time than prescribed. Properly stop the medication when so||
0945|076|H|directed.||
0945|077|H|   When this medication is used for a long time, it may not work||
0945|078|H|as well. Talk with your doctor if this medication stops working||
0945|079|H|well.||
0945|080|H|   Tell your doctor if your condition does not get better or if||
0945|081|H|it gets worse.||
0945|082|B|||
0945|083|S|SIDE EFFECTS:  Nausea, vomiting, constipation, stomach/abdominal||
0945|084|S|pain, loss of appetite, dry mouth, headache, nervousness,||
0945|085|S|dizziness, trouble sleeping, sweating, weight loss, irritability,||
0945|086|S|and restlessness may occur. If any of these effects last or get||
0945|087|S|worse, tell your doctor or pharmacist promptly.||
0945|088|S|   Remember that this medication has been prescribed because your||
0945|089|S|doctor has judged that the benefit to you is greater than the||
0945|090|S|risk of side effects. Many people using this medication do not||
0945|091|S|have serious side effects.||
0945|092|S|   This medication may raise your blood pressure. Check your||
0945|093|S|blood pressure regularly and tell your doctor if the results are||
0945|094|S|high.||
0945|095|S|   Tell your doctor right away if you have any serious side||
0945|096|S|effects, including: blurred vision, fast/pounding/irregular||
0945|097|S|heartbeat, mental/mood/behavior changes (such as agitation,||
0945|098|S|aggression, mood swings, depression, hallucinations, abnormal||
0945|099|S|thoughts/behavior, suicidal thoughts/attempts), uncontrolled||
0945|100|S|movements, muscle twitching/shaking, signs of blood flow problems||
0945|101|S|in the fingers or toes (such as coldness, numbness, pain, or skin||
0945|102|S|color changes), unusual wounds on the fingers or toes, outbursts||
0945|103|S|of words/sounds, change in sexual ability/interest, swelling||
0945|104|S|ankles/feet, extreme tiredness, rapid/unexplained weight loss,||
0945|105|S|frequent/prolonged erections (in males).||
0945|106|S|   Get medical help right away if you have any very serious side||
0945|107|S|effects, including: shortness of breath, fainting, chest/jaw/left||
0945|108|S|arm pain, seizures, weakness on one side of the body, trouble||
0945|109|S|speaking, confusion, sudden vision changes.||
0945|110|S|   This medication may increase serotonin and rarely cause a very||
0945|111|S|serious condition called serotonin syndrome/toxicity. The risk||
0945|112|S|increases if you are also taking other drugs that increase||
0945|113|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
0945|114|S|take (see Drug Interactions section). Get medical help right away||
0945|115|S|if you develop some of the following symptoms: fast heartbeat,||
0945|116|S|hallucinations, loss of coordination, severe dizziness, severe||
0945|117|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
0945|118|S|unusual agitation/restlessness.||
0945|119|S|   A very serious allergic reaction to this drug is rare.||
0945|120|S|However, get medical help right away if you notice any symptoms||
0945|121|S|of a serious allergic reaction, including: rash, itching/swelling||
0945|122|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0945|123|S|breathing.||
0945|124|S|   This is not a complete list of possible side effects. If you||
0945|125|S|notice other effects not listed above, contact your doctor or||
0945|126|S|pharmacist.||
0945|127|S|   In the US -||
0945|128|S|   Call your doctor for medical advice about side effects. You||
0945|129|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0945|130|S|www.fda.gov/medwatch.||
0945|131|S|   In Canada - Call your doctor for medical advice about side||
0945|132|S|effects. You may report side effects to Health Canada at||
0945|133|S|1-866-234-2345.||
0945|134|B|||
0945|135|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
0945|136|P|pharmacist if you are allergic to it; or to other sympathomimetic||
0945|137|P|drugs (such as amphetamine or dextroamphetamine); or if you have||
0945|138|P|any other allergies. This product may contain inactive||
0945|139|P|ingredients, which can cause allergic reactions or other||
0945|140|P|problems. Talk to your pharmacist for more details.||
0945|141|P|   Before using this medication, tell your doctor or pharmacist||
0945|142|P|your medical history, especially of: blood circulation problems||
0945|143|P|(such as Raynaud's disease), certain mental/mood conditions (such||
0945|144|P|as severe agitation, psychosis), personal/family history of||
0945|145|P|mental/mood disorders (such as bipolar disorder, depression,||
0945|146|P|psychotic disorder, suicidal thoughts), heart problems (including||
0945|147|P|irregular heartbeat, coronary artery disease, previous heart||
0945|148|P|attack, heart failure, cardiomyopathy, problems with heart||
0945|149|P|structure such as valve problems), family history of heart||
0945|150|P|problems (such as sudden death, irregular heartbeat), history of||
0945|151|P|stroke, high blood pressure, overactive thyroid||
0945|152|P|(hyperthyroidism), a certain eye problem (glaucoma), seizures,||
0945|153|P|kidney disease, personal or family history of a substance use||
0945|154|P|disorder (such as overuse of or addiction to drugs/alcohol),||
0945|155|P|personal/family history of uncontrolled muscle movements (such as||
0945|156|P|Tourette's syndrome).||
0945|157|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0945|158|P|can make you more dizzy. Do not drive, use machinery, or do||
0945|159|P|anything that needs alertness until you can do it safely. Limit||
0945|160|P|alcoholic beverages. Talk to your doctor if you are using||
0945|161|P|marijuana (cannabis).||
0945|162|P|   Before having surgery, tell your doctor or dentist about all||
0945|163|P|the products you use (including prescription drugs,||
0945|164|P|nonprescription drugs, and herbal products).||
0945|165|P|   Children (especially those younger than 6) may be more||
0945|166|P|sensitive to the side effects of this drug, especially weight||
0945|167|P|loss. This medication may slow down a child's growth. The doctor||
0945|168|P|may recommend temporarily stopping the medication from time to||
0945|169|P|time to reduce this risk. Monitor your child's weight and height.||
0945|170|P|Consult your doctor or pharmacist for more details.||
0945|171|P|   During pregnancy, this medication should be used only if||
0945|172|P|clearly needed. Discuss the risks and benefits with your doctor.||
0945|173|P|Infants born to mothers who are dependent on this medication may||
0945|174|P|be born too soon (premature) and have low birth weight. They may||
0945|175|P|also have withdrawal symptoms. Tell your doctor right away if you||
0945|176|P|notice possible mood changes, agitation, or unusual tiredness in||
0945|177|P|your newborn.||
0945|178|P|   This medication passes into breast milk and may have||
0945|179|P|undesirable effects on a nursing infant. Breastfeeding is not||
0945|180|P|recommended while using this medication. Consult your doctor||
0945|181|P|before breastfeeding.||
0945|182|B|||
0945|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0945|184|I|medications work or increase your risk for serious side effects.||
0945|185|I|This document does not contain all possible drug interactions.||
0945|186|I|Keep a list of all the products you use (including||
0945|187|I|prescription/nonprescription drugs and herbal products) and share||
0945|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
0945|189|I|the dosage of any medicines without your doctor's approval.||
0945|190|I|   Taking MAO inhibitors with this medication may cause a serious||
0945|191|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0945|192|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0945|193|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0945|194|I|selegiline, tranylcypromine) during treatment with this||
0945|195|I|medication. Most MAO inhibitors should also not be taken for two||
0945|196|I|weeks before treatment with this medication. Ask your doctor when||
0945|197|I|to start or stop taking this medication.||
0945|198|I|   Some products have ingredients that could raise your heart||
0945|199|I|rate or blood pressure. Tell your pharmacist what products you||
0945|200|I|are using, and ask how to use them safely (especially||
0945|201|I|cough-and-cold products or diet aids).||
0945|202|I|   The risk of serotonin syndrome/toxicity increases if you are||
0945|203|I|also taking other drugs that increase serotonin. Examples include||
0945|204|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
0945|205|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
0945|206|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
0945|207|I|serotonin syndrome/toxicity may be more likely when you start or||
0945|208|I|increase the dose of these drugs.||
0945|209|I|   Lisdexamfetamine is very similar to amphetamine or||
0945|210|I|dextroamphetamine. Do not use medications containing amphetamine||
0945|211|I|or dextroamphetamine while using lisdexamfetamine.||
0945|212|I|   This medication may interfere with certain lab tests (such as||
0945|213|I|blood and urine steroid levels), possibly causing false test||
0945|214|I|results. Make sure lab personnel and all your doctors know you||
0945|215|I|use this drug.||
0945|216|B|||
0945|217|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0945|218|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0945|219|O|poison control center right away. US residents can call||
0945|220|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0945|221|O|Symptoms of overdose may include: severe mental/mood changes||
0945|222|O|(such as confusion, hallucinations), seizures, irregular||
0945|223|O|heartbeat, severe restlessness, fast breathing.||
0945|224|B|||
0945|225|N|NOTES:  Do not share this medication with others. Sharing it is||
0945|226|N|against the law.||
0945|227|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
0945|228|N|growth monitoring in children) may be done while you are taking||
0945|229|N|this medication. Keep all medical and lab appointments. Consult||
0945|230|N|your doctor for more details.||
0945|231|B|||
0945|232|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
0945|233|D|in the morning hours. If it is after noon or near the time of the||
0945|234|D|next dose, skip the missed dose. Take your next dose at the||
0945|235|D|regular time. Do not double the dose to catch up.||
0945|236|B|||
0945|237|R|STORAGE:  Store at room temperature away from light and moisture.||
0945|238|R|Do not store in the bathroom. Keep all medications away from||
0945|239|R|children and pets.||
0945|240|R|   Do not flush medications down the toilet or pour them into a||
0945|241|R|drain unless instructed to do so. Properly discard this product||
0945|242|R|when it is expired or no longer needed. Consult your pharmacist||
0945|243|R|or local waste disposal company.||
0945|244|B|||
0945|245|A|Information last revised September 2025.||
0945|246|A|Copyright(c) 2025 First Databank, Inc.||
0945|247|B|||
0946|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0946|002|Z|does NOT have all possible information about this product. This||
0946|003|Z|information does not assure that this product is safe, effective,||
0946|004|Z|or appropriate for you. This information is not individual||
0946|005|Z|medical advice and does not substitute for the advice of your||
0946|006|Z|health care professional. Always ask your health care||
0946|007|Z|professional for complete information about this product and your||
0946|008|Z|specific health needs.||
0946|009|B|||
0946|010|T|DEXTROMETHORPHAN/ACETAMINOPHEN - ORAL||
0946|011|F|(DEX-troe-meth-OR-fan/a-SEET-a-MIN-oh-fen)||
0946|012|B|||
0946|013|C|COMMON BRAND NAME(S): Tylenol Cough & Sore throat||
0946|014|B|||
0946|015|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
0946|016|W|too much acetaminophen may cause serious (possibly fatal) liver||
0946|017|W|disease. Adults should not take more than 4000 milligrams (4||
0946|018|W|grams) of acetaminophen a day. People with liver problems and||
0946|019|W|children should take less acetaminophen. Ask your doctor or||
0946|020|W|pharmacist how much acetaminophen is safe to take.||
0946|021|W|   Do not use with any other drug containing acetaminophen||
0946|022|W|without asking your doctor or pharmacist first. Acetaminophen is||
0946|023|W|in many nonprescription and prescription medications (such as||
0946|024|W|pain/fever drugs or cough-and-cold products). Check the labels on||
0946|025|W|all your medicines to see if they contain acetaminophen, and ask||
0946|026|W|your pharmacist if you are unsure.||
0946|027|W|   Get medical help right away if you take too much acetaminophen||
0946|028|W|(overdose), even if you feel well. Overdose symptoms may include||
0946|029|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
0946|030|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
0946|031|W|   Daily alcohol use, especially when combined with||
0946|032|W|acetaminophen, may damage your liver. Avoid alcohol.||
0946|033|B|||
0946|034|U|USES:  This combination product is used to temporarily treat||
0946|035|U|cough, fever, and other symptoms (such as headache, sore throat,||
0946|036|U|body aches) that are caused by the common cold, flu, or other||
0946|037|U|breathing illnesses (such as bronchitis). Dextromethorphan is a||
0946|038|U|cough suppressant that affects a certain part of the brain (cough||
0946|039|U|center), reducing the urge to cough. Acetaminophen is a||
0946|040|U|non-aspirin pain reliever and fever reducer.||
0946|041|U|   This product is not usually used for ongoing coughs from||
0946|042|U|smoking, asthma, or other long-term breathing problems (such as||
0946|043|U|emphysema), or for coughs with a lot of mucus, unless directed by||
0946|044|U|your doctor.||
0946|045|U|   Cough-and-cold products have not been shown to be safe or||
0946|046|U|effective in children younger than 6 years. Do not use this||
0946|047|U|product to treat cold symptoms in children younger than 6 years||
0946|048|U|unless specifically directed by the doctor. Some products (such||
0946|049|U|as long-acting tablets/capsules) are not recommended for use in||
0946|050|U|children younger than 12 years. Ask your doctor or pharmacist for||
0946|051|U|more details about using your product safely.||
0946|052|U|   These products do not cure or shorten the length of the common||
0946|053|U|cold and may cause serious side effects. To decrease the risk for||
0946|054|U|serious side effects, carefully follow all dosage directions. Do||
0946|055|U|not use this product to make a child sleepy. Do not give other||
0946|056|U|cough-and-cold medication that might contain the same or similar||
0946|057|U|ingredients (see also Drug Interactions section). Ask the doctor||
0946|058|U|or pharmacist about other ways to relieve cough and cold symptoms||
0946|059|U|(such as drinking enough fluids, using a humidifier or saline||
0946|060|U|nose drops/spray).||
0946|061|B|||
0946|062|H|HOW TO USE:  See also Warning section.||
0946|063|H|   Read and follow all directions on the product package before||
0946|064|H|taking this medication. If any of the information is unclear,||
0946|065|H|consult your doctor or pharmacist.||
0946|066|H|   Take this medication by mouth, usually every 4 to 6 hours as||
0946|067|H|needed, or as directed by your doctor. This medication can be||
0946|068|H|taken with food or milk if stomach upset occurs.||
0946|069|H|   If you are using the liquid form, carefully measure the dose||
0946|070|H|using a medication-measuring device or spoon. Do not use a||
0946|071|H|household spoon because you may not get the correct dose. If your||
0946|072|H|liquid is a suspension, shake the container well before measuring||
0946|073|H|each dose.||
0946|074|H|   If you are using the powder form, dissolve the contents of||
0946|075|H|each packet in 8 ounces (240 milliliters) of water as directed on||
0946|076|H|the product package. Drink within 10 to 15 minutes of mixing.||
0946|077|H|   If you are using chewable tablets, chew each tablet thoroughly||
0946|078|H|before swallowing.||
0946|079|H|   The dosage is based on age and weight. Check the package label||
0946|080|H|to find the correct dose.||
0946|081|H|   Improper use of this medication (abuse) may result in serious||
0946|082|H|harm (such as brain damage, seizure, death). Do not increase your||
0946|083|H|dose or take it more often than directed.||
0946|084|H|   Tell your doctor if your condition lasts for more than 7 days,||
0946|085|H|if it gets worse, or if it occurs with a headache that doesn't go||
0946|086|H|away, rash, or fever lasting more than 3 days.||
0946|087|B|||
0946|088|S|SIDE EFFECTS:  See also Warning section.||
0946|089|S|   Dizziness, drowsiness, nausea, or vomiting may occur. If any||
0946|090|S|of these effects last or get worse, tell your doctor or||
0946|091|S|pharmacist promptly.||
0946|092|S|   If your doctor has directed you to use this medication,||
0946|093|S|remember that your doctor has judged that the benefit to you is||
0946|094|S|greater than the risk of side effects. Many people using this||
0946|095|S|medication do not have serious side effects.||
0946|096|S|   A very serious allergic reaction to this drug is rare.||
0946|097|S|However, get medical help right away if you notice any symptoms||
0946|098|S|of a serious allergic reaction, including: rash, itching/swelling||
0946|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0946|100|S|breathing.||
0946|101|S|   This is not a complete list of possible side effects. If you||
0946|102|S|notice other effects not listed above, contact your doctor or||
0946|103|S|pharmacist.||
0946|104|S|   In the US -||
0946|105|S|   Call your doctor for medical advice about side effects. You||
0946|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0946|107|S|www.fda.gov/medwatch.||
0946|108|S|   In Canada - Call your doctor for medical advice about side||
0946|109|S|effects. You may report side effects to Health Canada at||
0946|110|S|1-866-234-2345.||
0946|111|B|||
0946|112|P|PRECAUTIONS:  See also Warning section.||
0946|113|P|   Before using this product, tell your doctor or pharmacist if||
0946|114|P|you are allergic to dextromethorphan or acetaminophen; or if you||
0946|115|P|have any other allergies. This product may contain inactive||
0946|116|P|ingredients, which can cause allergic reactions or other||
0946|117|P|problems. Talk to your pharmacist for more details.||
0946|118|P|   If you have any of the following health problems, consult your||
0946|119|P|doctor or pharmacist before using this product: breathing||
0946|120|P|problems (such as asthma, emphysema), liver disease, use/abuse of||
0946|121|P|alcohol.||
0946|122|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0946|123|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0946|124|P|machinery, or do anything that needs alertness until you can do||
0946|125|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0946|126|P|are using marijuana (cannabis).||
0946|127|P|   Liquid products, chewable tablets, and powder packets may||
0946|128|P|contain sugar or aspartame. Liquid products may also contain||
0946|129|P|alcohol. Caution is advised if you have diabetes, alcohol||
0946|130|P|dependence, liver disease, phenylketonuria (PKU), or any other||
0946|131|P|condition that requires you to limit/avoid these substances in||
0946|132|P|your diet. Ask your doctor or pharmacist about using this drug||
0946|133|P|safely.||
0946|134|P|   Some brands of this medication contain sodium. Ask your doctor||
0946|135|P|or pharmacist for more information if you are on a||
0946|136|P|salt-restricted diet or if you have a condition that could be||
0946|137|P|worsened by an increase in salt intake.||
0946|138|P|   Before having surgery, tell your doctor or dentist about all||
0946|139|P|the products you use (including prescription drugs,||
0946|140|P|nonprescription drugs, and herbal products).||
0946|141|P|   During pregnancy, this medication should be used only when||
0946|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
0946|143|P|   This medication passes into breast milk. Consult your doctor||
0946|144|P|before breastfeeding.||
0946|145|B|||
0946|146|I|DRUG INTERACTIONS:  See also Warning section.||
0946|147|I|   Drug interactions may change how your medications work or||
0946|148|I|increase your risk for serious side effects. This document does||
0946|149|I|not contain all possible drug interactions. Keep a list of all||
0946|150|I|the products you use (including prescription/nonprescription||
0946|151|I|drugs and herbal products) and share it with your doctor and||
0946|152|I|pharmacist. Do not start, stop, or change the dosage of any||
0946|153|I|medicines without your doctor's approval.||
0946|154|I|   Taking certain MAO inhibitors with this medication may cause a||
0946|155|I|serious (possibly fatal) drug interaction. Avoid taking||
0946|156|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
0946|157|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
0946|158|I|tranylcypromine during treatment with this medication. Most MAO||
0946|159|I|inhibitors should also not be taken for two weeks before||
0946|160|I|treatment with this medication. Ask your doctor when to start or||
0946|161|I|stop taking this medication.||
0946|162|I|   Some products that may interact with this drug are:||
0946|163|I|ketoconazole, levoketoconazole, rolapitant.||
0946|164|I|   The ingredients in this product are available in many||
0946|165|I|prescription and nonprescription products. Check the labels on||
0946|166|I|all your medications carefully to make sure you are not taking||
0946|167|I|more than one product with the same ingredient(s). Consult your||
0946|168|I|pharmacist if you are unsure of the ingredients in any of your||
0946|169|I|medications.||
0946|170|I|   Tell your doctor or pharmacist if you are taking other||
0946|171|I|products that cause drowsiness such as opioid pain or cough||
0946|172|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0946|173|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0946|174|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0946|175|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0946|176|I|diphenhydramine).||
0946|177|I|   Check the labels on all your medicines (such as allergy or||
0946|178|I|cough-and-cold products) because they may contain ingredients||
0946|179|I|that cause drowsiness. Ask your pharmacist about using those||
0946|180|I|products safely.||
0946|181|I|   This medication may interfere with certain urine lab tests||
0946|182|I|(such as 5-HIAA levels), possibly causing false test results.||
0946|183|I|Make sure lab personnel and all your doctors know you use this||
0946|184|I|drug.||
0946|185|B|||
0946|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0946|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0946|188|O|poison control center right away. US residents can call||
0946|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0946|190|O|Symptoms of overdose may include: nausea, vomiting, loss of||
0946|191|O|appetite, sweating, stomach/abdominal pain, extreme tiredness,||
0946|192|O|yellowing eyes/skin, dark urine, fast heartbeat, nervousness,||
0946|193|O|abnormal/extreme feelings of well-being (euphoria),||
0946|194|O|hallucinations, problems walking (staggering), agitation, severe||
0946|195|O|drowsiness.||
0946|196|B|||
0946|197|N|NOTES:  Keep all medical and lab appointments.||
0946|198|B|||
0946|199|D|MISSED DOSE:  If you are taking this product on a regular||
0946|200|D|schedule and miss a dose, take it as soon as you remember. If it||
0946|201|D|is near the time of the next dose, skip the missed dose. Take||
0946|202|D|your next dose at the regular time. Do not double the dose to||
0946|203|D|catch up.||
0946|204|B|||
0946|205|R|STORAGE:  Refer to storage information printed on the package.||
0946|206|R|Protect from light and moisture. Do not store in the bathroom.||
0946|207|R|Keep all medication away from children and pets.||
0946|208|R|   Do not flush medications down the toilet or pour them into a||
0946|209|R|drain unless instructed to do so. Properly discard this product||
0946|210|R|when it is expired or no longer needed. Consult your pharmacist||
0946|211|R|or local waste disposal company.||
0946|212|B|||
0946|213|A|Information last revised July 2025.||
0946|214|A|Copyright(c) 2025 First Databank, Inc.||
0946|215|B|||
0947|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0947|002|Z|does NOT have all possible information about this product. This||
0947|003|Z|information does not assure that this product is safe, effective,||
0947|004|Z|or appropriate for you. This information is not individual||
0947|005|Z|medical advice and does not substitute for the advice of your||
0947|006|Z|health care professional. Always ask your health care||
0947|007|Z|professional for complete information about this product and your||
0947|008|Z|specific health needs.||
0947|009|B|||
0947|010|T|PRALIDOXIME AUTO-INJECTOR - INJECTION||
0947|011|F|(PRAL-i-DOX-eem)||
0947|012|B|||
0947|013|U|USES:  This medication is used with atropine to treat nerve agent||
0947|014|U|poisoning by certain chemicals known as anticholinesterase agents||
0947|015|U|(such as organophosphate pesticides such as parathion, "nerve||
0947|016|U|gas" such as sarin, other nerve agents such as VX). Pralidoxime||
0947|017|U|works by restoring the activity of a certain natural substance||
0947|018|U|(cholinesterase) needed by nerves and muscles. Symptoms of nerve||
0947|019|U|agent poisoning may include trouble breathing, headache, runny||
0947|020|U|nose, drooling, vision changes, sweating, abdominal cramps,||
0947|021|U|nausea, vomiting, diarrhea, muscle twitching/jerking, drowsiness,||
0947|022|U|confusion, and seizures.||
0947|023|U|   Pralidoxime works mostly on the muscles (including breathing||
0947|024|U|muscles) to decrease twitching, cramping, weakness, and||
0947|025|U|paralysis. Another medication (atropine) is used to treat these||
0947|026|U|and other symptoms of nerve agent poisoning such as slow/shallow||
0947|027|U|breathing, wheezing, increased sweating/saliva, abdominal cramps,||
0947|028|U|vomiting, and diarrhea.||
0947|029|B|||
0947|030|H|HOW TO USE:  Talk with your doctor about when you should use this||
0947|031|H|product. Know the symptoms of nerve agent poisoning. (See also||
0947|032|H|Uses section.)||
0947|033|H|   Learn how to properly inject this medication in advance so you||
0947|034|H|will be prepared if you actually need to use it. Also teach||
0947|035|H|another person what to do in case you cannot inject the||
0947|036|H|medication yourself.||
0947|037|H|   This medication is given by injection into the muscle of the||
0947|038|H|outer thigh, through clothing if necessary, as soon as possible||
0947|039|H|after exposure to a nerve agent. Another drug (atropine) is||
0947|040|H|usually injected first. Inject this drug (pralidoxime) after the||
0947|041|H|atropine. Hold the injector firmly in place for 10 seconds.||
0947|042|H|Massage the area of injection.||
0947|043|H|   To prevent further exposure to poison, the victim (and any||
0947|044|H|others who treat or have contact with the victim) must right away||
0947|045|H|put on protective equipment (such as breathing mask, gloves) and||
0947|046|H|perform rapid decontamination procedures (such as removing||
0947|047|H|contaminated clothing, washing skin and hair with sodium||
0947|048|H|bicarbonate or alcohol).||
0947|049|H|   Pralidoxime is most effective when used within 24 hours after||
0947|050|H|exposure. If symptoms of poisoning (such as increase in saliva,||
0947|051|H|difficulty breathing, muscle weakness) are still present 15||
0947|052|H|minutes after the injections, you may give another dose of both||
0947|053|H|atropine and pralidoxime. If needed, you may give a third set of||
0947|054|H|injections 15 minutes later.||
0947|055|H|   Get medical help right away for follow-up treatment. Do not||
0947|056|H|give more than 3 injections unless directed by a doctor.||
0947|057|H|   Dosage is based on your medical condition and poisoning||
0947|058|H|symptoms.||
0947|059|B|||
0947|060|S|SIDE EFFECTS:  Dizziness, drowsiness, or pain at the injection||
0947|061|S|site may occur. Normal effects from atropine include flushing,||
0947|062|S|large pupils, fast heartbeat, and dryness of the mouth and nose.||
0947|063|S|If any of these effects last or get worse, tell your doctor,||
0947|064|S|pharmacist, or other health care professional promptly.||
0947|065|S|   Remember that this medication has been prescribed because your||
0947|066|S|doctor has judged that the benefit to you is greater than the||
0947|067|S|risk of side effects. Many people using this medication do not||
0947|068|S|have serious side effects.||
0947|069|S|   A very serious allergic reaction to this drug is rare.||
0947|070|S|However, get medical help right away if you notice any symptoms||
0947|071|S|of a serious allergic reaction, including: rash, itching/swelling||
0947|072|S|(especially of the face/tongue/throat), worsening dizziness,||
0947|073|S|worsening trouble breathing.||
0947|074|S|   This is not a complete list of possible side effects. If you||
0947|075|S|notice other effects not listed above, contact your doctor or||
0947|076|S|pharmacist.||
0947|077|S|   In the US -||
0947|078|S|   Call your doctor for medical advice about side effects. You||
0947|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0947|080|S|www.fda.gov/medwatch.||
0947|081|S|   In Canada - Call your doctor for medical advice about side||
0947|082|S|effects. You may report side effects to Health Canada at||
0947|083|S|1-866-234-2345.||
0947|084|B|||
0947|085|P|PRECAUTIONS:  Before using pralidoxime, tell your doctor or||
0947|086|P|pharmacist if you are allergic to it; or if you have any other||
0947|087|P|allergies. This product may contain inactive ingredients, which||
0947|088|P|can cause allergic reactions or other problems. Talk to your||
0947|089|P|pharmacist for more details.||
0947|090|P|   Before using this medication, tell your doctor or pharmacist||
0947|091|P|your medical history, especially of: kidney disease, a certain||
0947|092|P|nerve/muscle problem (myasthenia gravis).||
0947|093|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0947|094|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0947|095|P|machinery, or do anything that needs alertness until you can do||
0947|096|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0947|097|P|are using marijuana (cannabis).||
0947|098|P|   During pregnancy, this medication should be used only when||
0947|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
0947|100|P|   It is unknown if this drug passes into breast milk. Consult||
0947|101|P|your doctor before breastfeeding.||
0947|102|B|||
0947|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0947|104|I|medications work or increase your risk for serious side effects.||
0947|105|I|This document does not contain all possible drug interactions.||
0947|106|I|Keep a list of all the products you use (including||
0947|107|I|prescription/nonprescription drugs and herbal products) and share||
0947|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
0947|109|I|the dosage of any medicines without your doctor's approval.||
0947|110|B|||
0947|111|O|OVERDOSE:  If this drug is injected accidentally without exposure||
0947|112|O|to a nerve agent or if someone has overdosed and has serious||
0947|113|O|symptoms such as passing out or trouble breathing, call 911.||
0947|114|O|Otherwise, call a poison control center right away. US residents||
0947|115|O|can call 1-800-222-1222. Canada residents can call||
0947|116|O|1-844-764-7669. In people not exposed to nerve agents, symptoms||
0947|117|O|of overdose may include: dizziness, vision problems, headache,||
0947|118|O|nausea, fast heartbeat.||
0947|119|B|||
0947|120|N|NOTES:  After first-aid treatment and decontamination, more||
0947|121|N|treatment in a hospital is usually needed. Consult your doctor||
0947|122|N|for more details.||
0947|123|B|||
0947|124|D|MISSED DOSE:  Not applicable.||
0947|125|B|||
0947|126|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
0947|127|R|medications away from children and pets.||
0947|128|R|   From time to time, check the expiration date, and also check||
0947|129|R|this product visually for particles or discoloration. Replace the||
0947|130|R|unit before it expires or if particles/discoloration are present.||
0947|131|R|   Do not flush medications down the toilet or pour them into a||
0947|132|R|drain unless instructed to do so. Properly discard this||
0947|133|R|medication when it is expired, used, or no longer needed. Consult||
0947|134|R|your pharmacist or local waste disposal provider.||
0947|135|B|||
0947|136|A|Information last revised December 2024.||
0947|137|A|Copyright(c) 2025 First Databank, Inc.||
0947|138|B|||
0949|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0949|002|Z|does NOT have all possible information about this product. This||
0949|003|Z|information does not assure that this product is safe, effective,||
0949|004|Z|or appropriate for you. This information is not individual||
0949|005|Z|medical advice and does not substitute for the advice of your||
0949|006|Z|health care professional. Always ask your health care||
0949|007|Z|professional for complete information about this product and your||
0949|008|Z|specific health needs.||
0949|009|B|||
0949|010|T|MORPHINE AUTO-INJECTOR - INJECTION||
0949|011|F|(MOR-feen)||
0949|012|B|||
0949|013|W|WARNING:  Morphine has a risk for abuse and addiction, which can||
0949|014|W|lead to overdose and death. Morphine may also cause severe,||
0949|015|W|possibly fatal, breathing problems. To lower your risk, your||
0949|016|W|doctor should have you use the smallest dose of morphine that||
0949|017|W|works, and use it for the shortest possible time. See also How to||
0949|018|W|Use section for more information about addiction.||
0949|019|W|   Ask your doctor or pharmacist if you should have medication||
0949|020|W|available to treat opioid overdose (such as naloxone, nalmefene).||
0949|021|W|Teach your family or household members about the signs of an||
0949|022|W|opioid overdose and how to treat it.||
0949|023|W|   The risk for severe breathing problems is higher when you||
0949|024|W|start this medication and after a dose increase, or if you use||
0949|025|W|the wrong dose/strength. Using this medication with alcohol or||
0949|026|W|other drugs that can cause drowsiness or breathing problems may||
0949|027|W|cause very serious side effects, including death. Be sure you||
0949|028|W|know how to use morphine and what other drugs you should avoid||
0949|029|W|using with it. See also Drug Interactions section. Get medical||
0949|030|W|help right away if any of these very serious side effects occur:||
0949|031|W|slow/shallow breathing, unusual lightheadedness, severe||
0949|032|W|drowsiness/dizziness, difficulty waking up.||
0949|033|W|   Keep this medicine in a safe place to prevent theft, misuse,||
0949|034|W|or abuse. If someone accidentally uses or swallows this drug, get||
0949|035|W|medical help right away.||
0949|036|W|   Before using this medication, women of childbearing age should||
0949|037|W|talk with their doctor(s) about the risks and benefits. Tell your||
0949|038|W|doctor if you are pregnant or if you plan to become pregnant.||
0949|039|W|During pregnancy, this medication should be used only when||
0949|040|W|clearly needed. It may slightly increase the risk of birth||
0949|041|W|defects if used during the first two months of pregnancy. Also,||
0949|042|W|using it for a long time or in high doses near the expected||
0949|043|W|delivery date may harm the unborn baby. To lessen the risk, use||
0949|044|W|the smallest effective dose for the shortest possible time.||
0949|045|W|Babies born to mothers who use this drug for a long time may||
0949|046|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
0949|047|W|doctor right away if you notice any symptoms in your newborn baby||
0949|048|W|such as crying that doesn't stop, slow/shallow breathing,||
0949|049|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
0949|050|W|difficulty gaining weight.||
0949|051|B|||
0949|052|U|USES:  This product is used to treat moderate-to-severe pain in||
0949|053|U|emergencies. Morphine belongs to a class of drugs known as opioid||
0949|054|U|analgesics. It works in the brain to change how your body feels||
0949|055|U|and responds to pain.||
0949|056|U|   This product delivers one fixed dose of morphine and is not||
0949|057|U|recommended for use in children who are younger than 14 years or||
0949|058|U|who weigh less than 90 pounds (40 kilograms).||
0949|059|B|||
0949|060|H|HOW TO USE:  This medication is given by injection into the||
0949|061|H|muscle of the outer thigh, through clothing if necessary, as||
0949|062|H|directed. If you do not get good pain relief after 30 minutes, a||
0949|063|H|second dose may be given if so directed. This product is meant to||
0949|064|H|be used in emergencies only, so it is not usually given||
0949|065|H|repeatedly. However, if this product needs to be given||
0949|066|H|repeatedly, it is given as directed by the doctor, usually every||
0949|067|H|4 hours as needed.||
0949|068|H|   If you will be giving this medication to yourself, learn how||
0949|069|H|to properly inject this medication in advance so you will be||
0949|070|H|prepared if you actually need to use it. Lying down when||
0949|071|H|receiving this medication may help to reduce side effects such as||
0949|072|H|nausea, vomiting, and dizziness. Discard the injector properly||
0949|073|H|after use. If you have any questions about using this medication||
0949|074|H|properly, consult your doctor or pharmacist.||
0949|075|H|   Pain medications work best if they are used as the first signs||
0949|076|H|of pain occur. If you wait until the pain has worsened, the||
0949|077|H|medication may not work as well.||
0949|078|H|   Suddenly stopping this medication may cause withdrawal,||
0949|079|H|especially if you have used it for a long time or in high doses.||
0949|080|H|To prevent withdrawal, your doctor may lower your dose slowly.||
0949|081|H|Tell your doctor or pharmacist right away if you have any||
0949|082|H|withdrawal symptoms such as restlessness, mental/mood changes||
0949|083|H|(including anxiety, trouble sleeping, thoughts of suicide),||
0949|084|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
0949|085|H|aches, or sudden changes in behavior.||
0949|086|H|   Though it helps many people, this medication may sometimes||
0949|087|H|cause addiction. This risk may be higher if you have a||
0949|088|H|mental/mood disorder or a substance use disorder (such as overuse||
0949|089|H|of or addiction to drugs/alcohol). Use this medication exactly as||
0949|090|H|prescribed to lower the risk of addiction. Ask your doctor or||
0949|091|H|pharmacist for more details.||
0949|092|H|   This product is meant to be used in emergencies, not for a||
0949|093|H|long time. If morphine is used for a long time, it may not work||
0949|094|H|as well and may require different dosing. Talk with your doctor||
0949|095|H|if your morphine stops working well.||
0949|096|H|   Tell your doctor if your pain does not get better or if it||
0949|097|H|gets worse, or if you have any new pain.||
0949|098|B|||
0949|099|S|SIDE EFFECTS:  See also Warning section.||
0949|100|S|   Nausea, vomiting, dry mouth, constipation, flushing, increased||
0949|101|S|sweating, lightheadedness, swelling/pain/itching at injection||
0949|102|S|site, dizziness, or drowsiness may occur. If any of these effects||
0949|103|S|last or get worse, tell your doctor or pharmacist promptly.||
0949|104|S|   To reduce the risk of dizziness and lightheadedness, get up||
0949|105|S|slowly when rising from a sitting or lying position.||
0949|106|S|   To prevent constipation, eat dietary fiber, drink enough||
0949|107|S|water, and exercise. You may also need to take a laxative. Ask||
0949|108|S|your pharmacist which type of laxative is right for you.||
0949|109|S|   Remember that this medication has been prescribed because your||
0949|110|S|doctor has judged that the benefit to you is greater than the||
0949|111|S|risk of side effects. Many people using this medication do not||
0949|112|S|have serious side effects.||
0949|113|S|   Tell your doctor right away if you have any serious side||
0949|114|S|effects, including: interrupted breathing during sleep (sleep||
0949|115|S|apnea), severe stomach/abdominal pain, mental/mood changes,||
0949|116|S|vision changes, difficulty urinating, signs of your adrenal||
0949|117|S|glands not working well (such as loss of appetite, unusual||
0949|118|S|tiredness, weight loss), trouble swallowing.||
0949|119|S|   Get medical help right away if you have any very serious side||
0949|120|S|effects, including: slow/shallow breathing, fainting, slow/fast||
0949|121|S|heartbeat, severe drowsiness/difficulty waking up, seizures.||
0949|122|S|   A very serious allergic reaction to this drug is rare.||
0949|123|S|However, get medical help right away if you notice any symptoms||
0949|124|S|of a serious allergic reaction, including: rash, itching/swelling||
0949|125|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0949|126|S|breathing.||
0949|127|S|   This is not a complete list of possible side effects. If you||
0949|128|S|notice other effects not listed above, contact your doctor or||
0949|129|S|pharmacist.||
0949|130|S|   In the US -||
0949|131|S|   Call your doctor for medical advice about side effects. You||
0949|132|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0949|133|S|www.fda.gov/medwatch.||
0949|134|S|   In Canada - Call your doctor for medical advice about side||
0949|135|S|effects. You may report side effects to Health Canada at||
0949|136|S|1-866-234-2345.||
0949|137|B|||
0949|138|P|PRECAUTIONS:  Before using morphine, tell your doctor or||
0949|139|P|pharmacist if you are allergic to it; or to other opioid pain||
0949|140|P|medications (such as codeine); or if you have any other||
0949|141|P|allergies. This product may contain inactive ingredients, which||
0949|142|P|can cause allergic reactions or other problems. Talk to your||
0949|143|P|pharmacist for more details.||
0949|144|P|   Before using this medication, tell your doctor or pharmacist||
0949|145|P|your medical history, especially of: brain disorders (such as||
0949|146|P|head injury, tumor, seizures), breathing problems (such as||
0949|147|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
0949|148|P|kidney disease, liver disease, mental/mood disorders (such as||
0949|149|P|confusion, depression), personal or family history of a substance||
0949|150|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
0949|151|P|stomach/intestinal problems (such as blockage, constipation,||
0949|152|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
0949|153|P|(such as due to enlarged prostate), gallbladder disease, disease||
0949|154|P|of the pancreas (pancreatitis).||
0949|155|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0949|156|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0949|157|P|machinery, or do anything that needs alertness until you can do||
0949|158|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0949|159|P|are using marijuana (cannabis).||
0949|160|P|   Before having surgery, tell your doctor or dentist about all||
0949|161|P|the products you use (including prescription drugs,||
0949|162|P|nonprescription drugs, and herbal products).||
0949|163|P|   Older adults may be more sensitive to the side effects of this||
0949|164|P|drug, especially confusion, dizziness, drowsiness, and||
0949|165|P|slow/shallow breathing.||
0949|166|P|   During pregnancy, this medication should be used only when||
0949|167|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
0949|168|P|benefits with your doctor. (See also Warning section.)||
0949|169|P|   This drug passes into breast milk and may have undesirable||
0949|170|P|effects on a nursing infant. Tell the doctor right away if your||
0949|171|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
0949|172|P|breathing. Consult your doctor before breastfeeding.||
0949|173|B|||
0949|174|I|DRUG INTERACTIONS:  See also Warning section.||
0949|175|I|   Drug interactions may change how your medications work or||
0949|176|I|increase your risk for serious side effects. This document does||
0949|177|I|not contain all possible drug interactions. Keep a list of all||
0949|178|I|the products you use (including prescription/nonprescription||
0949|179|I|drugs and herbal products) and share it with your doctor and||
0949|180|I|pharmacist. Do not start, stop, or change the dosage of any||
0949|181|I|medicines without your doctor's approval.||
0949|182|I|   Some products that may interact with this drug include:||
0949|183|I|certain pain medications (mixed opioid agonist/antagonists such||
0949|184|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
0949|185|I|samidorphan.||
0949|186|I|   The risk of serious side effects (such as slow/shallow||
0949|187|I|breathing, severe drowsiness/dizziness) may be increased if this||
0949|188|I|medication is used with other products that may also cause||
0949|189|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
0949|190|I|if you are using other products such as other opioid pain or||
0949|191|I|cough relievers (such as codeine, hydrocodone), alcohol,||
0949|192|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
0949|193|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
0949|194|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
0949|195|I|cetirizine, diphenhydramine).||
0949|196|I|   Check the labels on all your medicines (such as allergy or||
0949|197|I|cough-and-cold products) because they may contain ingredients||
0949|198|I|that cause drowsiness. Ask your pharmacist about using those||
0949|199|I|products safely.||
0949|200|I|   This medication may interfere with certain lab tests (such as||
0949|201|I|amylase/lipase levels), possibly causing false test results. Make||
0949|202|I|sure lab personnel and all your doctors know you use this drug.||
0949|203|B|||
0949|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0949|205|O|as passing out or trouble breathing, give them naloxone or||
0949|206|O|nalmefene if available, then call 911. If the person is awake and||
0949|207|O|has no symptoms, call a poison control center right away. US||
0949|208|O|residents can call 1-800-222-1222. Canada residents can call||
0949|209|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
0949|210|O|breathing, severe drowsiness, coma.||
0949|211|B|||
0949|212|N|NOTES:  Do not share this medication with others. Sharing it is||
0949|213|N|against the law.||
0949|214|B|||
0949|215|D|MISSED DOSE:  Not applicable.||
0949|216|B|||
0949|217|R|STORAGE:  Store at room temperature away from light and moisture.||
0949|218|R|Do not freeze. Keep all medications away from children and pets.||
0949|219|R|   Do not flush medications down the toilet or pour them into a||
0949|220|R|drain unless instructed to do so. Properly discard this product||
0949|221|R|when it is expired or no longer needed. Consult your pharmacist||
0949|222|R|or local waste disposal company.||
0949|223|B|||
0949|224|A|Information last revised August 2025.||
0949|225|A|Copyright(c) 2025 First Databank, Inc.||
0949|226|B|||
0951|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0951|002|Z|does NOT have all possible information about this product. This||
0951|003|Z|information does not assure that this product is safe, effective,||
0951|004|Z|or appropriate for you. This information is not individual||
0951|005|Z|medical advice and does not substitute for the advice of your||
0951|006|Z|health care professional. Always ask your health care||
0951|007|Z|professional for complete information about this product and your||
0951|008|Z|specific health needs.||
0951|009|B|||
0951|010|T|DEXTROMETHORPHAN/DECONGESTANT/ACETAMINOPHEN - ORAL||
0951|011|B|||
0951|012|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
0951|013|W|too much acetaminophen may cause serious (possibly fatal) liver||
0951|014|W|disease. Adults should not take more than 4000 milligrams (4||
0951|015|W|grams) of acetaminophen a day. People with liver problems and||
0951|016|W|children should take less acetaminophen. Ask your doctor or||
0951|017|W|pharmacist how much acetaminophen is safe to take.||
0951|018|W|   Do not use with any other drug containing acetaminophen||
0951|019|W|without asking your doctor or pharmacist first. Acetaminophen is||
0951|020|W|in many nonprescription and prescription medications (such as||
0951|021|W|pain/fever drugs or cough-and-cold products). Check the labels on||
0951|022|W|all your medicines to see if they contain acetaminophen, and ask||
0951|023|W|your pharmacist if you are unsure.||
0951|024|W|   Get medical help right away if you take too much acetaminophen||
0951|025|W|(overdose), even if you feel well. Overdose symptoms may include||
0951|026|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
0951|027|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
0951|028|W|   Daily alcohol use, especially when combined with||
0951|029|W|acetaminophen, may damage your liver. Avoid alcohol.||
0951|030|B|||
0951|031|U|USES:  This combination medication is used to temporarily treat||
0951|032|U|cough, stuffy nose, body aches, and other symptoms (such as||
0951|033|U|fever, headache, sore throat) caused by the common cold, flu, or||
0951|034|U|other breathing illnesses (such as sinusitis, bronchitis).||
0951|035|U|Dextromethorphan is a cough suppressant that affects a certain||
0951|036|U|part of the brain (cough center), reducing the urge to cough.||
0951|037|U|Decongestants help to relieve stuffy nose symptoms. This product||
0951|038|U|also contains acetaminophen, a non-aspirin pain reliever and||
0951|039|U|fever reducer.||
0951|040|U|   This medication is usually not used for ongoing coughs from||
0951|041|U|smoking, asthma, or other long-term breathing problems (such as||
0951|042|U|emphysema), or for coughs with a lot of mucus, unless directed by||
0951|043|U|your doctor.||
0951|044|U|   Cough-and-cold products have not been shown to be safe or||
0951|045|U|effective in children younger than 6 years. Do not use this||
0951|046|U|product to treat cold symptoms in children younger than 6 years||
0951|047|U|unless specifically directed by the doctor. Some products (such||
0951|048|U|as long-acting tablets/capsules) are not recommended for use in||
0951|049|U|children younger than 12 years. Ask your doctor or pharmacist for||
0951|050|U|more details about using your product safely.||
0951|051|U|   These products do not cure or shorten the length of the common||
0951|052|U|cold and may cause serious side effects. To decrease the risk for||
0951|053|U|serious side effects, carefully follow all dosage directions. Do||
0951|054|U|not use this product to make a child sleepy. Do not give other||
0951|055|U|cough-and-cold medication that might contain the same or similar||
0951|056|U|ingredients (see also Drug Interactions section). Ask the doctor||
0951|057|U|or pharmacist about other ways to relieve cough and cold symptoms||
0951|058|U|(such as drinking enough fluids, using a humidifier or saline||
0951|059|U|nose drops/spray).||
0951|060|B|||
0951|061|H|HOW TO USE:  See also Warning section.||
0951|062|H|   If you are taking the over-the-counter product, read all||
0951|063|H|directions on the product package before taking this medication.||
0951|064|H|If you have any questions, consult your pharmacist.||
0951|065|H|   Take this medication by mouth with or without food or as||
0951|066|H|directed by your doctor. This medication can be taken with food||
0951|067|H|or milk if stomach upset occurs.||
0951|068|H|   If you are using a liquid form, carefully measure your||
0951|069|H|prescribed dose using a medication-measuring device or spoon. Do||
0951|070|H|not use a household spoon because you may not get the correct||
0951|071|H|dose. If your liquid form is a suspension, shake the bottle well||
0951|072|H|before each dose.||
0951|073|H|   Chewable forms of this medication should be chewed thoroughly||
0951|074|H|before swallowing.||
0951|075|H|   The dosage is based on your age. Do not increase your dose or||
0951|076|H|take this medication more often than directed without your||
0951|077|H|doctor's approval. Improper use of this medication (abuse) may||
0951|078|H|result in serious harm (such as brain damage, seizure, death).||
0951|079|H|   Tell your doctor if your condition lasts for more than 1 week,||
0951|080|H|if it gets worse, or if it occurs with headache that doesn't go||
0951|081|H|away, rash, or fever lasting more than 3 days. These may be||
0951|082|H|symptoms of a serious medical problem and should be checked by a||
0951|083|H|doctor.||
0951|084|B|||
0951|085|S|SIDE EFFECTS:  See also Warning section.||
0951|086|S|   Dizziness, drowsiness, headache, nausea, nervousness, or||
0951|087|S|trouble sleeping may occur. If any of these effects last or get||
0951|088|S|worse, contact your doctor or pharmacist promptly.||
0951|089|S|   If your doctor has directed you to use this medication,||
0951|090|S|remember that your doctor has judged that the benefit to you is||
0951|091|S|greater than the risk of side effects. Many people using this||
0951|092|S|medication do not have serious side effects.||
0951|093|S|   This medication may raise your blood pressure. Check your||
0951|094|S|blood pressure regularly and tell your doctor if the results are||
0951|095|S|high.||
0951|096|S|   Tell your doctor right away if you have any serious side||
0951|097|S|effects, including: mental/mood changes (such as confusion,||
0951|098|S|hallucinations), shaking (tremors), weakness, problems urinating.||
0951|099|S|   Get medical help right away if you have any very serious side||
0951|100|S|effects, including: chest pain, fast/irregular heartbeat.||
0951|101|S|   A very serious allergic reaction to this drug is rare.||
0951|102|S|However, get medical help right away if you notice any symptoms||
0951|103|S|of a serious allergic reaction, including: rash, itching/swelling||
0951|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0951|105|S|breathing.||
0951|106|S|   This is not a complete list of possible side effects. If you||
0951|107|S|notice other effects not listed above, contact your doctor or||
0951|108|S|pharmacist.||
0951|109|S|   In the US -||
0951|110|S|   Call your doctor for medical advice about side effects. You||
0951|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0951|112|S|www.fda.gov/medwatch.||
0951|113|S|   In Canada - Call your doctor for medical advice about side||
0951|114|S|effects. You may report side effects to Health Canada at||
0951|115|S|1-866-234-2345.||
0951|116|B|||
0951|117|P|PRECAUTIONS:  See also Warning section.||
0951|118|P|   Before taking this medication, tell your doctor or pharmacist||
0951|119|P|if you are allergic to any of its ingredients; or if you have any||
0951|120|P|other allergies. This product may contain inactive ingredients,||
0951|121|P|which can cause allergic reactions or other problems. Talk to||
0951|122|P|your pharmacist for more details.||
0951|123|P|   Before using this medication, tell your doctor or pharmacist||
0951|124|P|your medical history, especially of: breathing problems (such as||
0951|125|P|asthma, emphysema), diabetes, glaucoma, heart problems, high||
0951|126|P|blood pressure, kidney problems, liver disease, overactive||
0951|127|P|thyroid (hyperthyroidism), trouble urinating (such as due to||
0951|128|P|enlarged prostate), use/abuse of alcohol.||
0951|129|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0951|130|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0951|131|P|machinery, or do anything that needs alertness until you can do||
0951|132|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0951|133|P|are using marijuana (cannabis).||
0951|134|P|   Liquid or chewable forms of this product may contain sugar or||
0951|135|P|aspartame. Liquid forms may also contain alcohol. Caution is||
0951|136|P|advised if you have diabetes, alcohol dependence, liver disease,||
0951|137|P|phenylketonuria (PKU), or any other condition that requires you||
0951|138|P|to limit/avoid these substances in your diet. Ask your doctor or||
0951|139|P|pharmacist about using this product safely.||
0951|140|P|   Before having surgery, tell your doctor or dentist about all||
0951|141|P|the products you use (including prescription drugs,||
0951|142|P|nonprescription drugs, and herbal products).||
0951|143|P|   Older adults may be more sensitive to the side effects of this||
0951|144|P|drug, especially fast/irregular heartbeat, dizziness, problems||
0951|145|P|urinating, trouble sleeping, or confusion.||
0951|146|P|   During pregnancy, this medication should be used only if||
0951|147|P|clearly needed. Discuss the risks and benefits with your doctor.||
0951|148|P|   This medication may pass into breast milk. Consult your doctor||
0951|149|P|before breastfeeding.||
0951|150|B|||
0951|151|I|DRUG INTERACTIONS:  See also Warning section.||
0951|152|I|   Drug interactions may change how your medications work or||
0951|153|I|increase your risk for serious side effects. This document does||
0951|154|I|not contain all possible drug interactions. Keep a list of all||
0951|155|I|the products you use (including prescription/nonprescription||
0951|156|I|drugs and herbal products) and share it with your doctor and||
0951|157|I|pharmacist. Do not start, stop, or change the dosage of any||
0951|158|I|medicines without your doctor's approval.||
0951|159|I|   Taking certain MAO inhibitors with this medication may cause a||
0951|160|I|serious (possibly fatal) drug interaction. Avoid taking||
0951|161|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
0951|162|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
0951|163|I|tranylcypromine during treatment with this medication. Most MAO||
0951|164|I|inhibitors should also not be taken for two weeks before||
0951|165|I|treatment with this medication. Ask your doctor when to start or||
0951|166|I|stop taking this medication.||
0951|167|I|   Some products that may interact with this drug are:||
0951|168|I|ketoconazole, levoketoconazole, rolapitant.||
0951|169|I|   The ingredients in this product are available in many||
0951|170|I|prescription and nonprescription products. Check the labels on||
0951|171|I|all your medications carefully to make sure you are not taking||
0951|172|I|more than one product with the same ingredient(s). Consult your||
0951|173|I|pharmacist if you are unsure of the ingredients in any of your||
0951|174|I|medications.||
0951|175|I|   Tell your doctor or pharmacist if you are taking other||
0951|176|I|products that cause drowsiness such as opioid pain or cough||
0951|177|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0951|178|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0951|179|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0951|180|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0951|181|I|diphenhydramine).||
0951|182|I|   Check the labels on all your medicines (such as allergy or||
0951|183|I|cough-and-cold products) because they may contain ingredients||
0951|184|I|that cause drowsiness. Ask your pharmacist about using those||
0951|185|I|products safely.||
0951|186|I|   This medication may interfere with certain urine lab tests||
0951|187|I|(such as 5-HIAA levels), possibly causing false test results.||
0951|188|I|Make sure lab personnel and all your doctors know you use this||
0951|189|I|drug.||
0951|190|B|||
0951|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0951|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0951|193|O|poison control center right away. US residents can call||
0951|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0951|195|O|Symptoms of overdose may include: nausea, vomiting, loss of||
0951|196|O|appetite, sweating, stomach/abdominal pain, extreme tiredness,||
0951|197|O|yellowing eyes/skin, dark urine, agitation, confusion,||
0951|198|O|hallucinations, seizures.||
0951|199|B|||
0951|200|N|NOTES:  Keep all medical and lab appointments.||
0951|201|B|||
0951|202|D|MISSED DOSE:  If your doctor has directed you to take this||
0951|203|D|medication on a regular schedule and you miss a dose, take it as||
0951|204|D|soon as you remember. If it is near the time of the next dose,||
0951|205|D|skip the missed dose. Take your next dose at the regular time. Do||
0951|206|D|not double the dose to catch up.||
0951|207|B|||
0951|208|R|STORAGE:  Store as directed on the package label. Protect from||
0951|209|R|light and moisture. Do not store in the bathroom. If you have any||
0951|210|R|questions about storage, ask your pharmacist. Keep all||
0951|211|R|medications away from children and pets.||
0951|212|R|   Do not flush medications down the toilet or pour them into a||
0951|213|R|drain unless instructed to do so. Properly discard this product||
0951|214|R|when it is expired or no longer needed. Consult your pharmacist||
0951|215|R|or local waste disposal company.||
0951|216|B|||
0951|217|A|Information last revised July 2025.||
0951|218|A|Copyright(c) 2025 First Databank, Inc.||
0951|219|B|||
0952|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0952|002|Z|does NOT have all possible information about this product. This||
0952|003|Z|information does not assure that this product is safe, effective,||
0952|004|Z|or appropriate for you. This information is not individual||
0952|005|Z|medical advice and does not substitute for the advice of your||
0952|006|Z|health care professional. Always ask your health care||
0952|007|Z|professional for complete information about this product and your||
0952|008|Z|specific health needs.||
0952|009|B|||
0952|010|T|ZOLEDRONIC ACID SOLUTION - INJECTION||
0952|011|F|(ZOLE-eh-dron-ick)||
0952|012|B|||
0952|013|C|COMMON BRAND NAME(S): Reclast||
0952|014|B|||
0952|015|U|USES:  This medication is used to treat a certain type of bone||
0952|016|U|disease (Paget's disease) that causes abnormal and weak bones.||
0952|017|U|Zoledronic acid is also used to treat bone loss (osteoporosis) in||
0952|018|U|men and in women after menopause who are at high risk of having||
0952|019|U|broken bones (fractures). It may also be used to treat or prevent||
0952|020|U|osteoporosis in people who are taking corticosteroid medications||
0952|021|U|(such as prednisone) for long periods. It works by slowing the||
0952|022|U|breakdown of bone and keeping bones strong. It also helps to||
0952|023|U|reduce the risk of broken bones (fractures). This medication||
0952|024|U|belongs to a class of drugs known as bisphosphonates.||
0952|025|B|||
0952|026|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0952|027|H|Patient Information Leaflet provided by your pharmacist before||
0952|028|H|you start using this product and each time you get a refill. If||
0952|029|H|you have any questions, ask your doctor or pharmacist.||
0952|030|H|   This medication is given as a single dose as directed by your||
0952|031|H|doctor. It is given slowly into a vein over at least 15 minutes.||
0952|032|H|The dosage is based on your medical condition and response to||
0952|033|H|treatment.||
0952|034|H|   For the treatment of Paget's disease, this medication is given||
0952|035|H|as a single dose and may be repeated based on your symptoms. For||
0952|036|H|the treatment of osteoporosis, this medication is given as a||
0952|037|H|single dose once a year. Talk to your doctor about the risks and||
0952|038|H|benefits of long-term use of this medication.||
0952|039|H|   Eat and drink normally on the day of treatment. Drink at least||
0952|040|H|2 glasses of fluid before treatment unless otherwise directed by||
0952|041|H|your doctor. It is very important that you get plenty of fluids||
0952|042|H|when you are given this medication.||
0952|043|H|   If you are giving this medication to yourself at home, learn||
0952|044|H|all preparation and usage instructions from your health care||
0952|045|H|professional. Before using, check this product for particles or||
0952|046|H|discoloration. If either is present, do not use the liquid. Learn||
0952|047|H|how to store and discard medical supplies safely.||
0952|048|H|   Avoid mixing zoledronic acid with IV fluids that have calcium||
0952|049|H|in them (such as Ringer's solution, Hartmann's solution,||
0952|050|H|parenteral nutrition-TPN/PPN). Talk to your pharmacist for more||
0952|051|H|details.||
0952|052|H|   Your doctor may direct you to take calcium and vitamin D each||
0952|053|H|day. If you have Paget's disease, it is especially important that||
0952|054|H|you take the directed amount of calcium and vitamin D during the||
0952|055|H|2 weeks after your zoledronic acid dose. Vitamin D and calcium||
0952|056|H|are very important to prevent low levels of calcium in the blood.||
0952|057|H|Tell your doctor right away if you have any symptoms of low||
0952|058|H|calcium such as numbness/tingling (especially around the||
0952|059|H|lips/mouth) and muscle spasms.||
0952|060|B|||
0952|061|S|SIDE EFFECTS:  Nausea, tiredness, flu-like symptoms (such as||
0952|062|S|fever, chills, muscle/joint aches), dizziness, headache, or||
0952|063|S|pain/redness/swelling at the injection site may occur. Most of||
0952|064|S|these side effects are mild and occur within 3 days of treatment.||
0952|065|S|Flu-like symptoms may be reduced by taking acetaminophen or||
0952|066|S|ibuprofen after the treatment. If any of these effects worsen or||
0952|067|S|last more than 4 days, tell your doctor or pharmacist promptly.||
0952|068|S|   Remember that this medication has been prescribed because your||
0952|069|S|doctor has judged that the benefit to you is greater than the||
0952|070|S|risk of side effects. Many people using this medication do not||
0952|071|S|have serious side effects.||
0952|072|S|   Tell your doctor right away if you have any serious side||
0952|073|S|effects, including: increased or severe bone/joint/muscle pain,||
0952|074|S|new or unusual hip/thigh/groin pain, jaw/ear pain, unusual||
0952|075|S|weakness, eye problems (such as redness/itching/swelling,||
0952|076|S|sensitivity to light), muscle spasms, numb/tingling skin,||
0952|077|S|irregular heartbeat, sores in jaw/mouth.||
0952|078|S|   Get medical help right away if you have any serious side||
0952|079|S|effects, including: signs of kidney problems (such as change in||
0952|080|S|the amount of urine), seizures.||
0952|081|S|   A very serious allergic reaction to this drug is rare.||
0952|082|S|However, get medical help right away if you notice any symptoms||
0952|083|S|of a serious allergic reaction, including: rash, itching/swelling||
0952|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0952|085|S|breathing.||
0952|086|S|   This is not a complete list of possible side effects. If you||
0952|087|S|notice other effects not listed above, contact your doctor or||
0952|088|S|pharmacist.||
0952|089|S|   In the US -||
0952|090|S|   Call your doctor for medical advice about side effects. You||
0952|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0952|092|S|www.fda.gov/medwatch.||
0952|093|S|   In Canada - Call your doctor for medical advice about side||
0952|094|S|effects. You may report side effects to Health Canada at||
0952|095|S|1-866-234-2345.||
0952|096|B|||
0952|097|P|PRECAUTIONS:  Before using zoledronic acid, tell your doctor or||
0952|098|P|pharmacist if you are allergic to it; or to other bisphosphonates||
0952|099|P|such as alendronate or risedronate; or if you have trouble||
0952|100|P|breathing (wheezing) after taking aspirin; or if you have any||
0952|101|P|other allergies. This product may contain inactive ingredients,||
0952|102|P|which can cause allergic reactions or other problems. Talk to||
0952|103|P|your pharmacist for more details.||
0952|104|P|   Before using this medication, tell your doctor or pharmacist||
0952|105|P|your medical history, especially of: kidney problems, low calcium||
0952|106|P|levels in the blood, problem taking calcium/vitamin D||
0952|107|P|supplements, recent or planned dental surgery (such as tooth||
0952|108|P|removal), certain gut problems (malabsorption, surgery on the||
0952|109|P|small intestine), treatment with zoledronic acid (such as for||
0952|110|P|cancer), parathyroid/thyroid problems (such as||
0952|111|P|hypoparathyroidism, thyroid/parathyroid surgery), dehydration.||
0952|112|P|   Some people using zoledronic acid may have serious jawbone||
0952|113|P|problems. Your doctor should check your mouth before you start||
0952|114|P|this medication. Tell your dentist that you are using this||
0952|115|P|medication before you have any dental work done. To help prevent||
0952|116|P|jawbone problems, have regular dental exams and learn how to keep||
0952|117|P|your teeth and gums healthy. If you have jaw pain, tell your||
0952|118|P|doctor and dentist right away.||
0952|119|P|   Before having any surgery (especially dental procedures), tell||
0952|120|P|your doctor and dentist about this medication and all other||
0952|121|P|products you use (including prescription drugs, nonprescription||
0952|122|P|drugs, and herbal products). Your doctor or dentist may tell you||
0952|123|P|to stop using zoledronic acid before your surgery. Ask for||
0952|124|P|specific instructions about stopping or starting this medication.||
0952|125|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0952|126|P|can make you more dizzy. Do not drive, use machinery, or do||
0952|127|P|anything that needs alertness until you can do it safely. Limit||
0952|128|P|alcoholic beverages. Talk to your doctor if you are using||
0952|129|P|marijuana (cannabis).||
0952|130|P|   Older adults may be at greater risk for kidney problems while||
0952|131|P|using this drug.||
0952|132|P|   Tell your doctor if you are pregnant or plan to become||
0952|133|P|pregnant. Zoledronic acid may stay in your body for many years.||
0952|134|P|You should not become pregnant while using zoledronic acid.||
0952|135|P|Zoledronic acid may harm an unborn baby. Ask about reliable forms||
0952|136|P|of birth control while using this medication and after the last||
0952|137|P|dose. If you become pregnant, talk to your doctor right away||
0952|138|P|about the risks and benefits of this medication.||
0952|139|P|   It is unknown if this drug passes into breast milk. Because of||
0952|140|P|the possible risk to the infant, breastfeeding is not recommended||
0952|141|P|while using this drug and after stopping treatment. This||
0952|142|P|medication may stay in your body for many years. Consult your||
0952|143|P|doctor before breastfeeding.||
0952|144|B|||
0952|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0952|146|I|medications work or increase your risk for serious side effects.||
0952|147|I|This document does not contain all possible drug interactions.||
0952|148|I|Keep a list of all the products you use (including||
0952|149|I|prescription/nonprescription drugs and herbal products) and share||
0952|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
0952|151|I|the dosage of any medicines without your doctor's approval.||
0952|152|I|   Some products that may interact with this drug include:||
0952|153|I|calcium-containing IV fluids.||
0952|154|I|   There is another zoledronic acid product that is used to treat||
0952|155|I|bone problems that may occur with cancer. That product should not||
0952|156|I|be used together with this medication.||
0952|157|B|||
0952|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0952|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0952|160|O|poison control center right away. US residents can call||
0952|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0952|162|B|||
0952|163|N|NOTES:  Lifestyle changes that help promote healthy bones include||
0952|164|N|increasing weight-bearing exercise, stopping smoking, limiting||
0952|165|N|alcohol, and eating well-balanced meals that contain adequate||
0952|166|N|calcium and vitamin D. Since you may also need to take calcium||
0952|167|N|and vitamin D supplements and make lifestyle changes, consult||
0952|168|N|your doctor for specific advice.||
0952|169|N|   Lab and/or medical tests (such as calcium/phosphate/magnesium||
0952|170|N|blood levels, bone density tests, kidney function) will be done||
0952|171|N|before you start using this medication and while you are using||
0952|172|N|it. Keep all medical and lab appointments. Consult your doctor||
0952|173|N|for more details.||
0952|174|B|||
0952|175|D|MISSED DOSE:  Not applicable.||
0952|176|B|||
0952|177|R|STORAGE:  Consult the product instructions and your pharmacist||
0952|178|R|for storage details. Keep all medications away from children and||
0952|179|R|pets.||
0952|180|R|   Do not flush medications down the toilet or pour them into a||
0952|181|R|drain unless instructed to do so. Properly discard this product||
0952|182|R|when it is expired or no longer needed. Consult your pharmacist||
0952|183|R|or local waste disposal company.||
0952|184|B|||
0952|185|A|Information last revised November 2024.||
0952|186|A|Copyright(c) 2025 First Databank, Inc.||
0952|187|B|||
0954|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0954|002|Z|does NOT have all possible information about this product. This||
0954|003|Z|information does not assure that this product is safe, effective,||
0954|004|Z|or appropriate for you. This information is not individual||
0954|005|Z|medical advice and does not substitute for the advice of your||
0954|006|Z|health care professional. Always ask your health care||
0954|007|Z|professional for complete information about this product and your||
0954|008|Z|specific health needs.||
0954|009|B|||
0954|010|T|FLUTICASONE FUROATE SPRAY - NASAL||
0954|011|F|(floo-TIK-a-sone FURE-oh-ate)||
0954|012|B|||
0954|013|C|COMMON BRAND NAME(S): Veramyst||
0954|014|B|||
0954|015|U|USES:  Fluticasone is used to treat seasonal and year-round||
0954|016|U|allergy symptoms such as stuffy/runny nose, itching, and||
0954|017|U|sneezing. It may also reduce other symptoms of seasonal allergies||
0954|018|U|such as red, itchy, and watery eyes. This medication belongs to a||
0954|019|U|class of drugs known as corticosteroids. It works by reducing||
0954|020|U|swelling (inflammation) in the nasal passages.||
0954|021|B|||
0954|022|H|HOW TO USE:  If you are using the over-the-counter product to||
0954|023|H|self-treat, read and follow all directions on the product package||
0954|024|H|before using this medication. If your doctor has prescribed this||
0954|025|H|medication, read the Patient Information Leaflet before you start||
0954|026|H|using fluticasone and each time you get a refill. If you have any||
0954|027|H|questions, ask your doctor or pharmacist.||
0954|028|H|   Use this medication in the nose as directed by your doctor or||
0954|029|H|the product package, usually once a day. Do not spray in your||
0954|030|H|eyes or mouth.||
0954|031|H|   Gently blow your nose before using this drug. Shake the||
0954|032|H|container well before each use. Follow the instructions on how to||
0954|033|H|properly prime the bottle if you are using it for the first time,||
0954|034|H|if you have not used it for more than 30 days, or if you have||
0954|035|H|left the cap off for 5 or more days.||
0954|036|H|   The dosage is based on your age, medical condition, and||
0954|037|H|response to treatment. Do not increase your dose or use this drug||
0954|038|H|more often or for longer than directed. Your condition will not||
0954|039|H|improve any faster, and your risk of side effects will increase.||
0954|040|H|You may be directed to start with a higher dose of this drug for||
0954|041|H|the first week until you have begun to feel better, then decrease||
0954|042|H|your dose. Children may need to use this drug for a shorter||
0954|043|H|amount of time to lower the risk of side effects. If a child is||
0954|044|H|using the over-the-counter product, read the package information||
0954|045|H|to see how long he/she should use it and when you should check||
0954|046|H|with the doctor.||
0954|047|H|   Use this medication regularly to get the most benefit from it.||
0954|048|H|To help you remember, use it at the same time each day.||
0954|049|H|   Clean the applicator regularly. Keep track of the number of||
0954|050|H|sprays used from the container. Discard the container after you||
0954|051|H|have used the number of sprays specified on the manufacturer's||
0954|052|H|package.||
0954|053|H|   This medication does not work right away. It may take several||
0954|054|H|days before you get the full benefit of this drug. Tell your||
0954|055|H|doctor if your condition does not get better after 1 week or if||
0954|056|H|it gets worse. If you think you may have a serious medical||
0954|057|H|problem, get medical help right away.||
0954|058|B|||
0954|059|S|SIDE EFFECTS:  Nosebleeds or sores in the nose may occur. If||
0954|060|S|either of these effects lasts or gets worse, tell your doctor or||
0954|061|S|pharmacist promptly.||
0954|062|S|   If your doctor has directed you to use this medication,||
0954|063|S|remember that your doctor has judged that the benefit to you is||
0954|064|S|greater than the risk of side effects. Many people using this||
0954|065|S|medication do not have serious side effects.||
0954|066|S|   Tell your doctor right away if you have any serious side||
0954|067|S|effects, including: sore throat that doesn't go away, signs of||
0954|068|S|nasal damage (such as pain, severe nosebleeds, a constant||
0954|069|S|whistling sound from your nose), facial pain, eye pain, white||
0954|070|S|patches in your nose/back of your throat, painful swallowing.||
0954|071|S|   Rarely, it is possible that corticosteroids given in the nose||
0954|072|S|will be absorbed into the bloodstream. This can lead to side||
0954|073|S|effects of too much corticosteroid. These side effects are more||
0954|074|S|likely in children and people who use this medication for a long||
0954|075|S|time and in high doses. Tell your doctor right away if any of the||
0954|076|S|following side effects occur: unusual/extreme tiredness, weight||
0954|077|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
0954|078|S|vision problems.||
0954|079|S|   A very serious allergic reaction to this drug is rare.||
0954|080|S|However, get medical help right away if you notice any symptoms||
0954|081|S|of a serious allergic reaction, including: rash, itching/swelling||
0954|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0954|083|S|breathing.||
0954|084|S|   This is not a complete list of possible side effects. If you||
0954|085|S|notice other effects not listed above, contact your doctor or||
0954|086|S|pharmacist.||
0954|087|S|   In the US -||
0954|088|S|   Call your doctor for medical advice about side effects. You||
0954|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0954|090|S|www.fda.gov/medwatch.||
0954|091|S|   In Canada - Call your doctor for medical advice about side||
0954|092|S|effects. You may report side effects to Health Canada at||
0954|093|S|1-866-234-2345.||
0954|094|B|||
0954|095|P|PRECAUTIONS:  Before using fluticasone, tell your doctor or||
0954|096|P|pharmacist if you are allergic to it; or if you have any other||
0954|097|P|allergies. This product may contain inactive ingredients, which||
0954|098|P|can cause allergic reactions or other problems. Talk to your||
0954|099|P|pharmacist for more details.||
0954|100|P|   Before using this medication, tell your doctor or pharmacist||
0954|101|P|your medical history, especially of: recent nose problems (such||
0954|102|P|as injury, ulcers, surgery), infections (including tuberculosis,||
0954|103|P|herpes eye infection), certain eye problems (glaucoma,||
0954|104|P|cataracts), liver disease.||
0954|105|P|   Stay away from anyone who has an infection that may easily||
0954|106|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0954|107|P|doctor if you have been exposed to an infection or for more||
0954|108|P|details.||
0954|109|P|   Rarely, using corticosteroid medications for a long time can||
0954|110|P|make it more difficult for your body to respond to physical||
0954|111|P|stress. Before having surgery or emergency treatment, or if you||
0954|112|P|get a serious illness/injury, tell your doctor or dentist that||
0954|113|P|you are using this medication or have used this medication within||
0954|114|P|the past few months.||
0954|115|P|   Though it is unlikely, this medication may temporarily slow||
0954|116|P|down a child's growth if used for a long time. See the doctor||
0954|117|P|regularly so your child's height can be checked.||
0954|118|P|   During pregnancy, this medication should be used only when||
0954|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
0954|120|P|   It is unknown if this drug passes into breast milk. Consult||
0954|121|P|your doctor before breastfeeding.||
0954|122|B|||
0954|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0954|124|I|medications work or increase your risk for serious side effects.||
0954|125|I|This document does not contain all possible drug interactions.||
0954|126|I|Keep a list of all the products you use (including||
0954|127|I|prescription/nonprescription drugs and herbal products) and share||
0954|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
0954|129|I|the dosage of any medicines without your doctor's approval.||
0954|130|I|   Other medications can affect the removal of fluticasone from||
0954|131|I|your body, which may affect how fluticasone works. Examples||
0954|132|I|include HIV protease inhibitors (such as lopinavir), ritonavir,||
0954|133|I|among others.||
0954|134|B|||
0954|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0954|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0954|137|O|poison control center right away. US residents can call||
0954|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0954|139|B|||
0954|140|N|NOTES:  Do not share this medication with others.||
0954|141|N|   If you use this medication for a long time, lab and/or medical||
0954|142|N|tests (such as nose exams, height measurement in children) may be||
0954|143|N|done while you are using this medication. Keep all medical and||
0954|144|N|lab appointments. Consult your doctor for more details.||
0954|145|N|   Avoid substances (such as pollen, pet dander, dust mites,||
0954|146|N|mold, and smoke) that can worsen allergy symptoms.||
0954|147|B|||
0954|148|D|MISSED DOSE:  If you are using this product on a regular schedule||
0954|149|D|and miss a dose, use it as soon as you remember. If it is near||
0954|150|D|the time of the next dose, skip the missed dose. Use your next||
0954|151|D|dose at the regular time. Do not double the dose to catch up.||
0954|152|B|||
0954|153|R|STORAGE:  Store upright with the cap on at room temperature. Do||
0954|154|R|not refrigerate or freeze. Keep all medications away from||
0954|155|R|children and pets.||
0954|156|R|   Do not flush medications down the toilet or pour them into a||
0954|157|R|drain unless instructed to do so. Properly discard this product||
0954|158|R|when it is expired or no longer needed. Consult your pharmacist||
0954|159|R|or local waste disposal company.||
0954|160|B|||
0954|161|A|Information last revised November 2024.||
0954|162|A|Copyright(c) 2025 First Databank, Inc.||
0954|163|B|||
0957|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0957|002|Z|does NOT have all possible information about this product. This||
0957|003|Z|information does not assure that this product is safe, effective,||
0957|004|Z|or appropriate for you. This information is not individual||
0957|005|Z|medical advice and does not substitute for the advice of your||
0957|006|Z|health care professional. Always ask your health care||
0957|007|Z|professional for complete information about this product and your||
0957|008|Z|specific health needs.||
0957|009|B|||
0957|010|T|ROTIGOTINE PATCH - TRANSDERMAL||
0957|011|F|(roe-TIG-oh-teen)||
0957|012|B|||
0957|013|C|COMMON BRAND NAME(S): Neupro||
0957|014|B|||
0957|015|U|USES:  Rotigotine is used alone or with other medications to||
0957|016|U|treat Parkinson's disease. It can improve your ability to move||
0957|017|U|and decrease shakiness (tremor), stiffness, slowed movement, and||
0957|018|U|unsteadiness. Rotigotine is also used to treat restless legs||
0957|019|U|syndrome (RLS).||
0957|020|U|   Rotigotine is a dopamine agonist that works by helping to||
0957|021|U|restore the balance of a certain natural substance (dopamine) in||
0957|022|U|the brain.||
0957|023|B|||
0957|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0957|025|H|from your pharmacist before you start using rotigotine and each||
0957|026|H|time you get a refill. Learn how to use this patch properly. If||
0957|027|H|you have any questions, ask your doctor or pharmacist.||
0957|028|H|   Do not open the sealed pouch until ready to use. Do not cut||
0957|029|H|the patch or use the patch if it appears broken, cut, or damaged.||
0957|030|H|Open the pouch and remove the patch. Peel off the backing from||
0957|031|H|the patch as directed and apply the patch to a clean, dry, and||
0957|032|H|hairless area of the skin on the front of the abdomen, thigh,||
0957|033|H|hip, side of the lower back (flank), shoulder, or upper arm.||
0957|034|H|Press the patch firmly in place for about 30 seconds to make sure||
0957|035|H|it stays on. Do not apply the patch on oily, broken, or irritated||
0957|036|H|skin. Do not use creams, lotions, ointments, oils, or powders on||
0957|037|H|skin where you are applying the patch. Avoid applying the patch||
0957|038|H|to areas of the skin where it might be easily rubbed off (such as||
0957|039|H|on skin folds or under tight clothing). If applying to a hairy||
0957|040|H|area, shave the area at least 3 days before applying the patch.||
0957|041|H|Wash your hands with soap and water after handling the patch. Do||
0957|042|H|not touch your eyes or other objects until your hands are washed.||
0957|043|H|   The patch is usually worn for 1 day and replaced. Apply the||
0957|044|H|patch to a different area on your body each time to avoid||
0957|045|H|irritation. Wait at least 14 days before applying the patch to||
0957|046|H|the same area. If the patch irritates the skin, protect the area||
0957|047|H|from direct sunlight until the skin is completely healed.||
0957|048|H|Sunlight may cause the irritated skin to change color.||
0957|049|H|   The dosage is based on your medical condition and response to||
0957|050|H|treatment. To reduce your risk of side effects (such as nausea,||
0957|051|H|dizziness), your doctor may direct you to start at a low dose and||
0957|052|H|gradually increase your dose. Follow your doctor's instructions||
0957|053|H|carefully.||
0957|054|H|   Use this medication regularly to get the most benefit from it.||
0957|055|H|To help you remember, change your patch at the same time each||
0957|056|H|day.||
0957|057|H|   To prevent the patch from coming off, use care while||
0957|058|H|showering, bathing, and exercising. If the edges of the patch||
0957|059|H|start to loosen, you may tape it in place with bandage tape. If||
0957|060|H|the patch falls off, apply a new patch to a different area, and||
0957|061|H|change the patch at your usual time the next day.||
0957|062|H|   When changing your patch, carefully remove the old patch, fold||
0957|063|H|it in half with the sticky side together, and throw it away in||
0957|064|H|the trash away from children and pets. Do not touch the sticky||
0957|065|H|side with your fingers. Wash the application area with soap and||
0957|066|H|water. Use baby oil or mineral oil to remove any leftover||
0957|067|H|stickiness. Do not use solvents such as alcohol or nail polish||
0957|068|H|remover. Always wash your hands after handling the patch, being||
0957|069|H|careful not to touch your eyes or other objects until after you||
0957|070|H|have washed your hands.||
0957|071|H|   Do not stop using this medication without consulting your||
0957|072|H|doctor. Some conditions may become worse when this medication is||
0957|073|H|suddenly stopped. Also, if you suddenly stop using this||
0957|074|H|medication, you may have withdrawal symptoms (such as anxiety,||
0957|075|H|depression, confusion, fever, muscle stiffness). To help prevent||
0957|076|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
0957|077|H|more likely if you have used rotigotine for a long time or in||
0957|078|H|high doses. Tell your doctor or pharmacist right away if you have||
0957|079|H|withdrawal.||
0957|080|H|   Tell your doctor if your condition does not get better or if||
0957|081|H|it gets worse.||
0957|082|B|||
0957|083|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, dizziness,||
0957|084|S|drowsiness, lightheadedness, tiredness, trouble sleeping,||
0957|085|S|increased sweating, headache, or redness/itching/swelling at the||
0957|086|S|application site may occur. If any of these effects last or get||
0957|087|S|worse, tell your doctor or pharmacist promptly.||
0957|088|S|   Remember that this medication has been prescribed because your||
0957|089|S|doctor has judged that the benefit to you is greater than the||
0957|090|S|risk of side effects. Many people using this medication do not||
0957|091|S|have serious side effects.||
0957|092|S|   Tell your doctor right away if you have any serious side||
0957|093|S|effects, including: mental/mood changes (such as confusion,||
0957|094|S|agitation, hallucinations), severe dizziness, fainting, unusual||
0957|095|S|strong urges (such as increased gambling, increased sexual||
0957|096|S|urges), swelling ankles/feet, unusual weight gain, fast||
0957|097|S|heartbeat, new or worsening uncontrolled movements.||
0957|098|S|   Some people using rotigotine have fallen asleep suddenly||
0957|099|S|during their usual daily activities (such as talking on the||
0957|100|S|phone, driving). In some cases, sleep occurred without any||
0957|101|S|feelings of drowsiness beforehand. This sleep effect may occur||
0957|102|S|anytime during treatment with rotigotine even if you have used||
0957|103|S|this medication for a long time. If you experience increased||
0957|104|S|sleepiness or fall asleep during the day, do not drive or take||
0957|105|S|part in other possibly dangerous activities until you have||
0957|106|S|discussed this effect with your doctor. Your risk of this sleep||
0957|107|S|effect is increased by using alcohol or other medications that||
0957|108|S|can make you drowsy. See also Precautions section.||
0957|109|S|   This medication may increase or decrease your blood pressure.||
0957|110|S|You may develop a sudden drop in blood pressure that can cause||
0957|111|S|dizziness, lightheadedness, nausea, sweating, and fainting. This||
0957|112|S|is more likely when you first start the medication, when your||
0957|113|S|dose is increased, or when you get up suddenly. To reduce your||
0957|114|S|risk, get up slowly when rising from a sitting or lying position.||
0957|115|S|Talk to your doctor if you need to check your blood pressure||
0957|116|S|while using this medication.||
0957|117|S|   A very serious allergic reaction to this drug is rare.||
0957|118|S|However, get medical help right away if you notice any symptoms||
0957|119|S|of a serious allergic reaction, including: rash, itching/swelling||
0957|120|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0957|121|S|breathing.||
0957|122|S|   This is not a complete list of possible side effects. If you||
0957|123|S|notice other effects not listed above, contact your doctor or||
0957|124|S|pharmacist.||
0957|125|S|   In the US -||
0957|126|S|   Call your doctor for medical advice about side effects. You||
0957|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0957|128|S|www.fda.gov/medwatch.||
0957|129|S|   In Canada - Call your doctor for medical advice about side||
0957|130|S|effects. You may report side effects to Health Canada at||
0957|131|S|1-866-234-2345.||
0957|132|B|||
0957|133|P|PRECAUTIONS:  Before using rotigotine, tell your doctor or||
0957|134|P|pharmacist if you are allergic to it; or if you have any other||
0957|135|P|allergies. This product may contain inactive ingredients (such as||
0957|136|P|sulfites), which can cause allergic reactions or other problems.||
0957|137|P|Talk to your pharmacist for more details.||
0957|138|P|   Before using this medication, tell your doctor or pharmacist||
0957|139|P|your medical history, especially of: asthma, sleep disorders||
0957|140|P|(such as sleep apnea, narcolepsy), low/high blood pressure, heart||
0957|141|P|disease (such as heart failure), kidney disease, mental/mood||
0957|142|P|disorders (such as schizophrenia).||
0957|143|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0957|144|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0957|145|P|machinery, or do anything that needs alertness until you can do||
0957|146|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0957|147|P|are using marijuana (cannabis). See also Side Effects section.||
0957|148|P|   While wearing your patch, avoid exposing it to direct heat||
0957|149|P|(such as heating pads, electric blankets, heat lamps, saunas, hot||
0957|150|P|tubs, heated waterbeds, or prolonged direct sunlight). Heat may||
0957|151|P|cause more drug to be released into your body, increasing the||
0957|152|P|risk of side effects.||
0957|153|P|   Before having surgery, tell your doctor or dentist about all||
0957|154|P|the products you use (including prescription drugs,||
0957|155|P|nonprescription drugs, and herbal products).||
0957|156|P|   If you are going to have an MRI test or cardioversion, tell||
0957|157|P|the health care provider that you are using this patch. Some||
0957|158|P|patches may contain metals that can cause serious burns during an||
0957|159|P|MRI or cardioversion. Ask your doctor whether you will need to||
0957|160|P|remove your patch before the procedure and apply a new patch||
0957|161|P|afterward, and how to do so properly.||
0957|162|P|   Older adults may be more sensitive to the side effects of this||
0957|163|P|drug, especially mental/mood changes (such as hallucinations)||
0957|164|P|   During pregnancy, this medication should be used only when||
0957|165|P|clearly needed. Discuss the risks and benefits with your doctor.||
0957|166|P|   It is unknown if this drug passes into breast milk. Consult||
0957|167|P|your doctor before breastfeeding.||
0957|168|B|||
0957|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0957|170|I|medications work or increase your risk for serious side effects.||
0957|171|I|This document does not contain all possible drug interactions.||
0957|172|I|Keep a list of all the products you use (including||
0957|173|I|prescription/nonprescription drugs and herbal products) and share||
0957|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
0957|175|I|the dosage of any medicines without your doctor's approval.||
0957|176|I|   Tell your doctor or pharmacist if you are taking other||
0957|177|I|products that cause drowsiness including alcohol, marijuana||
0957|178|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
0957|179|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
0957|180|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
0957|181|I|codeine).||
0957|182|I|   Check the labels on all your medicines (such as allergy or||
0957|183|I|cough-and-cold products) because they may contain ingredients||
0957|184|I|that cause drowsiness. Ask your pharmacist about using those||
0957|185|I|products safely.||
0957|186|B|||
0957|187|O|OVERDOSE:  This medication patch may be harmful if chewed or||
0957|188|O|swallowed. If someone has overdosed, remove the patch if||
0957|189|O|possible. For serious symptoms such as passing out or trouble||
0957|190|O|breathing, call 911. Otherwise, call a poison control center||
0957|191|O|right away. US residents can call 1-800-222-1222. Canada||
0957|192|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0957|193|O|include: mental/mood changes (such as confusion, hallucinations),||
0957|194|O|uncontrolled movements, seizures.||
0957|195|B|||
0957|196|N|NOTES:  Do not share this medication with others.||
0957|197|B|||
0957|198|D|MISSED DOSE:  If you forget to change the patch, change it as||
0957|199|D|soon as you remember. Do not double the dose to catch up. Then go||
0957|200|D|back to your usual schedule for changing your patch.||
0957|201|B|||
0957|202|R|STORAGE:  Store the patches at room temperature. Do not open the||
0957|203|R|pouch until you are ready to use the patch. Keep all medications||
0957|204|R|away from children and pets.||
0957|205|R|   Do not flush medications down the toilet or pour them into a||
0957|206|R|drain unless instructed to do so. Properly discard this product||
0957|207|R|when it is expired or no longer needed. Consult your pharmacist||
0957|208|R|or local waste disposal company. (See also How to Use section.)||
0957|209|B|||
0957|210|A|Information last revised October 2024.||
0957|211|A|Copyright(c) 2025 First Databank, Inc.||
0957|212|B|||
0958|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0958|002|Z|does NOT have all possible information about this product. This||
0958|003|Z|information does not assure that this product is safe, effective,||
0958|004|Z|or appropriate for you. This information is not individual||
0958|005|Z|medical advice and does not substitute for the advice of your||
0958|006|Z|health care professional. Always ask your health care||
0958|007|Z|professional for complete information about this product and your||
0958|008|Z|specific health needs.||
0958|009|B|||
0958|010|T|SODIUM SULFACETAMIDE/SULFUR FOAM - TOPICAL||
0958|011|F|(SO-dee-um sull-fuh-SEET-uh-mide/SULL-fur)||
0958|012|B|||
0958|013|C|COMMON BRAND NAME(S): Clarifoam EF||
0958|014|B|||
0958|015|U|USES:  This medication is used to treat several skin problems||
0958|016|U|(acne, rosacea, seborrheic dermatitis). Sodium sulfacetamide||
0958|017|U|belongs to a class of drugs known as sulfa antibiotics. It works||
0958|018|U|by killing certain bacteria on the skin that can lead to acne and||
0958|019|U|other problems. The sulfur in this product helps to remove dead||
0958|020|U|skin and unclog pores.||
0958|021|B|||
0958|022|H|HOW TO USE:  Follow all directions on the product package. If you||
0958|023|H|have any questions, ask your doctor or pharmacist.||
0958|024|H|   Use this medication on the skin only. To avoid irritation, do||
0958|025|H|not let this medication come into contact with your eyes, nose,||
0958|026|H|mouth, or any broken skin (such as cuts, scrapes, rashes). If you||
0958|027|H|do get the medication in those areas, flush the area with cool||
0958|028|H|water. Wash your hands with soap and water after each||
0958|029|H|application.||
0958|030|H|   Clean the area of skin with a mild cleanser and pat dry. Shake||
0958|031|H|the container well before each use. Depending on the brand||
0958|032|H|prescribed, you may need to prime the container before first use||
0958|033|H|by pressing down for 3 to 5 seconds until foam appears. Follow||
0958|034|H|the package directions for your specific brand. Some brands||
0958|035|H|should be held upright to dispense the foam, while other brands||
0958|036|H|should be held with the nozzle pointing downward. Holding the||
0958|037|H|container the wrong way can cause an incorrect amount of||
0958|038|H|medication to be dispensed. Follow the package directions for||
0958|039|H|your specific brand. Apply a small amount of foam on the||
0958|040|H|fingertips and massage the foam into the affected area. Depending||
0958|041|H|on the brand used, wait between 1 to 10 minutes. Rinse the area||
0958|042|H|well with water and pat dry. Your doctor may direct you not to||
0958|043|H|wash the foam off. In that case, massage the foam into the||
0958|044|H|affected area and wipe off any extra foam.||
0958|045|H|   Use this product as directed by your doctor. The dosage is||
0958|046|H|based on the brand you use, your medical condition, and response||
0958|047|H|to treatment.||
0958|048|H|   Use this medication regularly to get the most benefit from it.||
0958|049|H|To help you remember, use it at the same time(s) each day. Do not||
0958|050|H|use more of this medication, use it more often, or keep using it||
0958|051|H|for longer than prescribed. Your skin will not improve any||
0958|052|H|faster, and your risk of side effects may be increased.||
0958|053|H|   Tell your doctor if your acne does not get better or if it||
0958|054|H|gets worse.||
0958|055|B|||
0958|056|S|SIDE EFFECTS:  Redness/itching/swelling/flaking at the site of||
0958|057|S|application may occur. If any of these effects last or get worse,||
0958|058|S|tell your doctor or pharmacist promptly.||
0958|059|S|   Remember that this medication has been prescribed because your||
0958|060|S|doctor has judged that the benefit to you is greater than the||
0958|061|S|risk of side effects. Many people using this medication do not||
0958|062|S|have serious side effects.||
0958|063|S|   Although this effect is unlikely with sulfa medications that||
0958|064|S|are applied to the skin, serious side effects have rarely||
0958|065|S|occurred with other sulfa antibiotics that are taken by mouth.||
0958|066|S|Tell your doctor right away if you have any serious side effects,||
0958|067|S|including: easy bleeding/bruising, unexplained fever, fast||
0958|068|S|heartbeat, signs of infection (such as sore throat that doesn't||
0958|069|S|go away, fever, chills), bluish/pale skin, severe||
0958|070|S|stomach/abdominal pain, unusual tiredness, dark urine, yellowing||
0958|071|S|eyes/skin.||
0958|072|S|   A very serious allergic reaction to this drug is rare.||
0958|073|S|However, get medical help right away if you notice any symptoms||
0958|074|S|of a serious allergic reaction, including: rash, itching/swelling||
0958|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0958|076|S|breathing.||
0958|077|S|   This is not a complete list of possible side effects. If you||
0958|078|S|notice other effects not listed above, contact your doctor or||
0958|079|S|pharmacist.||
0958|080|S|   In the US -||
0958|081|S|   Call your doctor for medical advice about side effects. You||
0958|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0958|083|S|www.fda.gov/medwatch.||
0958|084|S|   In Canada - Call your doctor for medical advice about side||
0958|085|S|effects. You may report side effects to Health Canada at||
0958|086|S|1-866-234-2345.||
0958|087|B|||
0958|088|P|PRECAUTIONS:  Before using sulfacetamide with sulfur, tell your||
0958|089|P|doctor or pharmacist if you are allergic to sulfacetamide or||
0958|090|P|sulfur; or to other sulfa antibiotics (such as sulfamethoxazole,||
0958|091|P|sulfisoxazole); or if you have any other allergies. This product||
0958|092|P|may contain inactive ingredients, which can cause allergic||
0958|093|P|reactions or other problems. Talk to your pharmacist for more||
0958|094|P|details.||
0958|095|P|   Before using this medication, tell your doctor or pharmacist||
0958|096|P|your medical history, especially of: kidney disease.||
0958|097|P|   This medication may make you more sensitive to the sun. Limit||
0958|098|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
0958|099|P|sunscreen and wear protective clothing when outdoors. Tell your||
0958|100|P|doctor right away if you get sunburned or have skin||
0958|101|P|blisters/redness.||
0958|102|P|   Before having surgery, tell your doctor or dentist about all||
0958|103|P|the products you use (including prescription drugs,||
0958|104|P|nonprescription drugs, and herbal products).||
0958|105|P|   During pregnancy, this medication should be used only when||
0958|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
0958|107|P|   It is unknown if this drug passes into breast milk. Consult||
0958|108|P|your doctor before breastfeeding.||
0958|109|B|||
0958|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0958|111|I|medications work or increase your risk for serious side effects.||
0958|112|I|This document does not contain all possible drug interactions.||
0958|113|I|Keep a list of all the products you use (including||
0958|114|I|prescription/nonprescription drugs and herbal products) and share||
0958|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
0958|116|I|the dosage of any medicines without your doctor's approval.||
0958|117|I|   Some products that may interact with this drug are: products||
0958|118|I|containing silver that are applied to the skin (such as silver||
0958|119|I|sulfadiazine).||
0958|120|B|||
0958|121|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0958|122|O|has overdosed and has serious symptoms such as passing out or||
0958|123|O|trouble breathing, call 911. Otherwise, call a poison control||
0958|124|O|center right away. US residents can call 1-800-222-1222. Canada||
0958|125|O|residents can call 1-844-764-7669.||
0958|126|B|||
0958|127|N|NOTES:  Do not share this medication with others.||
0958|128|N|   Keep all medical appointments.||
0958|129|B|||
0958|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0958|131|D|If it is near the time of the next dose, skip the missed dose.||
0958|132|D|Use your next dose at the regular time. Do not double the dose to||
0958|133|D|catch up.||
0958|134|B|||
0958|135|R|STORAGE:  Store the product upright at room temperature. Do not||
0958|136|R|freeze. The contents of this can are under pressure. Do not||
0958|137|R|puncture or burn the container. Do not expose to open flame or||
0958|138|R|heat. Keep all medications away from children and pets.||
0958|139|R|   Do not flush medications down the toilet or pour them into a||
0958|140|R|drain unless instructed to do so. Properly discard this product||
0958|141|R|when it is expired or no longer needed. Consult your pharmacist||
0958|142|R|or local waste disposal company.||
0958|143|B|||
0958|144|A|Information last revised April 2025.||
0958|145|A|Copyright(c) 2025 First Databank, Inc.||
0958|146|B|||
0962|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0962|002|Z|does NOT have all possible information about this product. This||
0962|003|Z|information does not assure that this product is safe, effective,||
0962|004|Z|or appropriate for you. This information is not individual||
0962|005|Z|medical advice and does not substitute for the advice of your||
0962|006|Z|health care professional. Always ask your health care||
0962|007|Z|professional for complete information about this product and your||
0962|008|Z|specific health needs.||
0962|009|B|||
0962|010|T|BUDESONIDE/FORMOTEROL HFA INHALER - ORAL INHALATION||
0962|011|F|(bue-DES-oh-nide/for-MOE-ter-ol)||
0962|012|B|||
0962|013|C|COMMON BRAND NAME(S): Symbicort||
0962|014|B|||
0962|015|U|USES:  This product is used to control and prevent symptoms||
0962|016|U|(wheezing and shortness of breath) caused by asthma or ongoing||
0962|017|U|lung disease (chronic obstructive pulmonary disease-COPD, which||
0962|018|U|includes chronic bronchitis and emphysema). It contains 2||
0962|019|U|medications: budesonide and formoterol. Budesonide belongs to a||
0962|020|U|class of drugs known as corticosteroids. It works by reducing the||
0962|021|U|irritation and swelling of the airways. Formoterol belongs to the||
0962|022|U|class of drugs known as long-acting beta agonists. It works by||
0962|023|U|relaxing the muscles around the airways so that they open up and||
0962|024|U|you can breathe more easily. Controlling symptoms of breathing||
0962|025|U|problems can decrease time lost from work or school.||
0962|026|U|   When used alone, long-acting beta agonists (such as||
0962|027|U|formoterol) may rarely increase the risk of serious (sometimes||
0962|028|U|fatal) asthma-related breathing problems. However, combination||
0962|029|U|inhaled corticosteroid and long-acting beta agonists, such as||
0962|030|U|this product, do not increase the risk of serious asthma-related||
0962|031|U|breathing problems.||
0962|032|U|   Before using this medication, it is important to learn how to||
0962|033|U|use it properly. If an asthma attack occurs, use your||
0962|034|U|quick-relief inhaler (such as albuterol, also called salbutamol||
0962|035|U|in some countries) as prescribed. See also How to Use section.||
0962|036|B|||
0962|037|V|OTHER USES:  This section contains uses of this drug that are not||
0962|038|V|listed in the approved professional labeling for the drug but||
0962|039|V|that may be prescribed by your health care professional. Use this||
0962|040|V|drug for a condition that is listed in this section only if it||
0962|041|V|has been so prescribed by your health care professional.||
0962|042|V|   This medication may also be used for sudden breathing problems||
0962|043|V|caused by asthma (asthma attack).||
0962|044|B|||
0962|045|H|HOW TO USE:  Read the Patient Information Leaflet and||
0962|046|H|Instructions for Use provided by your pharmacist before you start||
0962|047|H|using this medication and each time you get a refill. Follow the||
0962|048|H|illustrated directions for the proper use of this medication. If||
0962|049|H|you have any questions, ask your doctor or pharmacist.||
0962|050|H|   Follow the instructions for priming the inhaler if you are||
0962|051|H|using it for the first time, if you have not used it for more||
0962|052|H|than 7 days, or if the inhaler was dropped. When priming the||
0962|053|H|inhaler, make sure to spray away from the face so that you do not||
0962|054|H|get the medication into your eyes.||
0962|055|H|   Shake the inhaler well for 5 seconds before each use. Inhale||
0962|056|H|this medication by mouth as directed by your doctor, usually||
0962|057|H|twice daily (in the morning and evening, 12 hours apart).||
0962|058|H|   If your prescribed dose is 2 puffs, wait at least one minute||
0962|059|H|between them. If you are using other inhalers at the same time,||
0962|060|H|wait at least 1 minute between the use of each medication, and||
0962|061|H|use this drug last.||
0962|062|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
0962|063|H|from developing, gargle, rinse your mouth with water and spit out||
0962|064|H|after each use. Do not swallow the rinse water.||
0962|065|H|   Clean the inhaler once a week with a dry cloth. Do not take||
0962|066|H|the inhaler apart.||
0962|067|H|   The dosage is based on your medical condition and response to||
0962|068|H|treatment.||
0962|069|H|   Use this medication regularly in order to get the most benefit||
0962|070|H|from it. This medication works best if used at evenly spaced||
0962|071|H|times. To help you remember, use it at the same times each day.||
0962|072|H|Do not increase your dose, use this medication more often, or||
0962|073|H|stop using it without first consulting your doctor. Also, do not||
0962|074|H|use other long-acting beta agonists while using this medication.||
0962|075|H|   If you are regularly taking a different corticosteroid by||
0962|076|H|mouth (such as prednisone), you should not stop taking it unless||
0962|077|H|directed by your doctor. Some conditions (such as asthma,||
0962|078|H|allergies) may become worse when the drug is suddenly stopped. If||
0962|079|H|you suddenly stop taking the drug, you may also have withdrawal||
0962|080|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
0962|081|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
0962|082|H|doctor may slowly lower the dose of your old medication after you||
0962|083|H|begin using budesonide/formoterol. Tell your doctor or pharmacist||
0962|084|H|right away if you have withdrawal. See also Precautions section.||
0962|085|H|   If you have been using a quick-relief inhaler (such as||
0962|086|H|albuterol, also called salbutamol in some countries) on a regular||
0962|087|H|daily schedule (such as 4 times daily), you must stop this||
0962|088|H|schedule and only use the quick-relief inhaler as needed for||
0962|089|H|sudden shortness of breath/asthma attacks. Consult your doctor||
0962|090|H|for details.||
0962|091|H|   It may take 1 week or longer before you get the full benefit||
0962|092|H|of this drug. Tell your doctor if your symptoms do not get better||
0962|093|H|or if they get worse.||
0962|094|H|   Learn which of your inhalers you should use every day||
0962|095|H|(controller drugs) and which you should use if your breathing||
0962|096|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
0962|097|H|time what you should do if you have new or worsening cough or||
0962|098|H|shortness of breath, wheezing, increased sputum, worsening peak||
0962|099|H|flow meter readings, waking up at night with trouble breathing,||
0962|100|H|if you use your quick-relief inhaler more often (more than 2 days||
0962|101|H|a week), or if your quick-relief inhaler does not seem to be||
0962|102|H|working well. Learn when you can treat sudden breathing problems||
0962|103|H|by yourself and when you must get medical help right away.||
0962|104|B|||
0962|105|S|SIDE EFFECTS:  Headache, throat irritation, or stomach upset may||
0962|106|S|occur. If any of these effects last or get worse, tell your||
0962|107|S|doctor promptly.||
0962|108|S|   Remember that this medication has been prescribed because your||
0962|109|S|doctor has judged that the benefit to you is greater than the||
0962|110|S|risk of side effects. Many people using this medication do not||
0962|111|S|have serious side effects.||
0962|112|S|   This medication may raise your blood pressure. Check your||
0962|113|S|blood pressure regularly and tell your doctor if the results are||
0962|114|S|high.||
0962|115|S|   Rarely, this medication may cause severe sudden worsening of||
0962|116|S|breathing problems/asthma immediately after use. If you have||
0962|117|S|sudden worsening of breathing, use your quick-relief inhaler and||
0962|118|S|get medical help right away.||
0962|119|S|   Tell your doctor right away if you have any serious side||
0962|120|S|effects, including: white patches on tongue/in mouth, signs of||
0962|121|S|infection (such as sore throat that doesn't go away, fever,||
0962|122|S|chills), mental/mood changes (such as nervousness), trouble||
0962|123|S|sleeping, vision problems (such as blurred vision), increased||
0962|124|S|thirst/urination, muscle cramps, shaking (tremors).||
0962|125|S|   Get medical help right away if you have any very serious side||
0962|126|S|effects, including: chest pain, fast/slow/irregular heartbeat,||
0962|127|S|severe dizziness, fainting, seizures.||
0962|128|S|   A very serious allergic reaction to this product is rare.||
0962|129|S|However, get medical help right away if you notice any symptoms||
0962|130|S|of a serious allergic reaction, including: rash, itching/swelling||
0962|131|S|(especially of the face/tongue/throat), severe dizziness, sudden||
0962|132|S|trouble breathing.||
0962|133|S|   This is not a complete list of possible side effects. If you||
0962|134|S|notice other effects not listed above, contact your doctor or||
0962|135|S|pharmacist.||
0962|136|S|   In the US -||
0962|137|S|   Call your doctor for medical advice about side effects. You||
0962|138|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0962|139|S|www.fda.gov/medwatch.||
0962|140|S|   In Canada - Call your doctor for medical advice about side||
0962|141|S|effects. You may report side effects to Health Canada at||
0962|142|S|1-866-234-2345.||
0962|143|B|||
0962|144|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
0962|145|P|pharmacist if you are allergic to budesonide or formoterol; or to||
0962|146|P|arformoterol; or if you have any other allergies. This product||
0962|147|P|may contain inactive ingredients, which can cause allergic||
0962|148|P|reactions or other problems. Talk to your pharmacist for more||
0962|149|P|details.||
0962|150|P|   Before using this medication, tell your doctor or pharmacist||
0962|151|P|your medical history, especially of: current/past infections||
0962|152|P|(such as tuberculosis, herpes), high blood pressure, heart||
0962|153|P|disease (such as chest pain, heart attack, irregular heartbeat),||
0962|154|P|overactive thyroid (hyperthyroidism), seizures, bone loss||
0962|155|P|(osteoporosis), eye problems (such as cataracts, glaucoma),||
0962|156|P|diabetes, liver disease, swelling of an artery (aneurysm), a||
0962|157|P|certain adrenal gland tumor (pheochromocytoma).||
0962|158|P|   Formoterol may cause a condition that affects the heart rhythm||
0962|159|P|(QT prolongation). QT prolongation can rarely cause serious||
0962|160|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0962|161|P|as severe dizziness, fainting) that need medical attention right||
0962|162|P|away.||
0962|163|P|   The risk of QT prolongation may be increased if you have||
0962|164|P|certain medical conditions or are taking other drugs that may||
0962|165|P|cause QT prolongation. Before using this product, tell your||
0962|166|P|doctor or pharmacist of all the drugs you take and if you have||
0962|167|P|any of the following conditions: certain heart problems (heart||
0962|168|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0962|169|P|history of certain heart problems (QT prolongation in the EKG,||
0962|170|P|sudden cardiac death).||
0962|171|P|   Low levels of potassium or magnesium in the blood may also||
0962|172|P|increase your risk of QT prolongation. This risk may increase if||
0962|173|P|you use certain drugs (such as diuretics/"water pills") or if you||
0962|174|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0962|175|P|Talk to your doctor about using this medication safely.||
0962|176|P|   This medication may mask signs of infection. It can make you||
0962|177|P|more likely to get infections or may make current infections||
0962|178|P|worse. Stay away from anyone who has an infection that may easily||
0962|179|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
0962|180|P|doctor if you have been exposed to an infection or for more||
0962|181|P|details.||
0962|182|P|   If you have switched from a corticosteroid taken by mouth||
0962|183|P|(such as prednisone tablets) to this inhaler within the past 12||
0962|184|P|months, or if you have been using this product in||
0962|185|P|higher-than-usual doses for a long time, it may be more difficult||
0962|186|P|for your body to respond to physical stress. Before having||
0962|187|P|surgery or emergency treatment, or if you get a serious||
0962|188|P|illness/injury, tell your doctor or dentist that you are using||
0962|189|P|this medication or have used a corticosteroid taken by mouth||
0962|190|P|within the past 12 months. Tell your doctor right away if you||
0962|191|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
0962|192|P|card or medical ID bracelet that says you use (or have used)||
0962|193|P|corticosteroid medications.||
0962|194|P|   Before having surgery, tell your doctor or dentist about all||
0962|195|P|the products you use (including prescription drugs,||
0962|196|P|nonprescription drugs, and herbal products).||
0962|197|P|   This medication may temporarily slow down a child's growth if||
0962|198|P|used for a long time. However, poorly controlled asthma can also||
0962|199|P|slow down growth. See the doctor regularly so your child's height||
0962|200|P|can be checked.||
0962|201|P|   Older adults may be more sensitive to the side effects of this||
0962|202|P|drug, especially QT prolongation (see above).||
0962|203|P|   During pregnancy, this medication should be used only when||
0962|204|P|clearly needed. Discuss the risks and benefits with your doctor.||
0962|205|P|   Budesonide passes into breast milk. It is unknown if||
0962|206|P|formoterol passes into breast milk. Consult your doctor before||
0962|207|P|breastfeeding.||
0962|208|B|||
0962|209|I|DRUG INTERACTIONS:  See also Uses section.||
0962|210|I|   Drug interactions may change how your medications work or||
0962|211|I|increase your risk for serious side effects. This document does||
0962|212|I|not contain all possible drug interactions. Keep a list of all||
0962|213|I|the products you use (including prescription/nonprescription||
0962|214|I|drugs and herbal products) and share it with your doctor and||
0962|215|I|pharmacist. Do not start, stop, or change the dosage of any||
0962|216|I|medicines without your doctor's approval.||
0962|217|I|   Some products that may interact with this drug include:||
0962|218|I|aldesleukin, desmopressin, mifepristone.||
0962|219|B|||
0962|220|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0962|221|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0962|222|O|poison control center right away. US residents can call||
0962|223|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0962|224|O|Symptoms of overdose may include: shaking (tremors), chest pain,||
0962|225|O|fast/irregular heartbeat, seizures.||
0962|226|B|||
0962|227|N|NOTES:  Do not share this medication with others.||
0962|228|N|   Lab and/or medical tests (such as lung function, blood||
0962|229|N|pressure, bone density tests, eye exams) may be done while you||
0962|230|N|are using this medication. Keep all medical and lab appointments.||
0962|231|N|Consult your doctor for more details.||
0962|232|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
0962|233|N|mold that can worsen breathing problems. Because the flu virus||
0962|234|N|can also worsen breathing problems, ask your doctor or pharmacist||
0962|235|N|if you should have a flu shot every year.||
0962|236|N|   This medication may cause bone loss (osteoporosis) in adults||
0962|237|N|when used for a long time. Lifestyle changes that may help reduce||
0962|238|N|the risk of bone problems include doing weight-bearing exercise,||
0962|239|N|stopping smoking, limiting alcohol, and getting enough calcium||
0962|240|N|and vitamin D. Talk to your doctor for more details.||
0962|241|B|||
0962|242|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
0962|243|D|next dose at the regular time. Do not double the dose to catch||
0962|244|D|up.||
0962|245|B|||
0962|246|R|STORAGE:  Store at room temperature away from heat. Do not||
0962|247|R|puncture the canister or use near an open flame. Store the||
0962|248|R|inhaler with the mouthpiece down. Do not open the original foil||
0962|249|R|package until you are ready to use the medication. Once the foil||
0962|250|R|package is opened, this medication expires after 3 months. Keep||
0962|251|R|all medications away from children and pets.||
0962|252|R|   Do not flush medications down the toilet or pour them into a||
0962|253|R|drain unless instructed to do so. Properly discard this product||
0962|254|R|when it is expired or no longer needed. Consult your pharmacist||
0962|255|R|or local waste disposal company.||
0962|256|B|||
0962|257|M|MEDICAL ALERT:  Your condition can cause complications in a||
0962|258|M|medical emergency. For information about enrolling in MedicAlert,||
0962|259|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0962|260|B|||
0962|261|A|Information last revised September 2025.||
0962|262|A|Copyright(c) 2025 First Databank, Inc.||
0962|263|B|||
0963|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0963|002|Z|does NOT have all possible information about this product. This||
0963|003|Z|information does not assure that this product is safe, effective,||
0963|004|Z|or appropriate for you. This information is not individual||
0963|005|Z|medical advice and does not substitute for the advice of your||
0963|006|Z|health care professional. Always ask your health care||
0963|007|Z|professional for complete information about this product and your||
0963|008|Z|specific health needs.||
0963|009|B|||
0963|010|T|QUETIAPINE SUSTAINED-RELEASE - ORAL||
0963|011|F|(kweh-TIE-ah-peen)||
0963|012|B|||
0963|013|C|COMMON BRAND NAME(S): Seroquel XR||
0963|014|B|||
0963|015|W|WARNING:  There may be a slightly increased risk of serious,||
0963|016|W|possibly fatal side effects (such as stroke, heart failure,||
0963|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
0963|018|W|by older adults with dementia. This medication is not approved||
0963|019|W|for the treatment of dementia-related behavior problems. Discuss||
0963|020|W|the risks and benefits of this medication, as well as other||
0963|021|W|effective and possibly safer treatments for dementia-related||
0963|022|W|behavior problems, with the doctor.||
0963|023|W|   If you are using quetiapine in combination with other||
0963|024|W|medication to treat depression, also carefully read the drug||
0963|025|W|information for the other medication.||
0963|026|W|   Quetiapine sustained-release is used to treat certain||
0963|027|W|mental/mood disorders (such as schizophrenia, bipolar disorder,||
0963|028|W|sudden episodes of mania or depression associated with bipolar||
0963|029|W|disorder). It is also used with other medications to treat||
0963|030|W|depression. Drugs used to treat depression can help prevent||
0963|031|W|suicidal thoughts/attempts and provide other important benefits.||
0963|032|W|However, studies have shown that a small number of people||
0963|033|W|(especially people younger than 25) who take drugs to treat||
0963|034|W|depression may experience worsening depression, other mental/mood||
0963|035|W|symptoms, or suicidal thoughts/attempts. It is very important to||
0963|036|W|talk with the doctor about the risks and benefits of drugs used||
0963|037|W|to treat depression (especially for people younger than 25), even||
0963|038|W|if treatment is not for a mental/mood condition.||
0963|039|W|   Tell the doctor right away if you notice worsening||
0963|040|W|depression/other psychiatric conditions, unusual behavior changes||
0963|041|W|(including possible suicidal thoughts/attempts), or other||
0963|042|W|mental/mood changes (including new/worsening anxiety, panic||
0963|043|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
0963|044|W|impulsive actions, severe restlessness, very rapid speech). Be||
0963|045|W|especially watchful for these symptoms when a new drug to treat||
0963|046|W|depression is started or when the dose is changed.||
0963|047|W|   This medication is not approved for use in children under 10||
0963|048|W|years old.||
0963|049|B|||
0963|050|U|USES:  This medication is used to treat certain mental/mood||
0963|051|U|disorders (such as schizophrenia, bipolar disorder, sudden||
0963|052|U|episodes of mania or depression associated with bipolar||
0963|053|U|disorder). It is also used with other medications to treat||
0963|054|U|depression. Quetiapine belongs to a class of drugs known as||
0963|055|U|atypical antipsychotics. It works by helping to restore the||
0963|056|U|balance of certain natural substances in the brain.||
0963|057|B|||
0963|058|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0963|059|H|Patient Information Leaflet provided by your pharmacist before||
0963|060|H|you start using quetiapine and each time you get a refill. If you||
0963|061|H|have any questions, ask your doctor or pharmacist.||
0963|062|H|   Take this medication by mouth as directed by your doctor,||
0963|063|H|usually once daily in the evening without food or with a light||
0963|064|H|meal. Swallow the tablets whole. Do not crush or chew the||
0963|065|H|tablets. Doing so can release all of the drug at once, increasing||
0963|066|H|the risk of side effects.||
0963|067|H|   The dosage is based on your medical condition, response to||
0963|068|H|treatment, and other medications you may be taking. Be sure to||
0963|069|H|tell your doctor and pharmacist about all the products you use||
0963|070|H|(including prescription drugs, nonprescription drugs, and herbal||
0963|071|H|products).||
0963|072|H|   To reduce your risk of side effects, your doctor may direct||
0963|073|H|you to start this medication at a low dose and gradually increase||
0963|074|H|your dose. Follow your doctor's instructions carefully. Take this||
0963|075|H|medication regularly to get the most benefit from it. To help you||
0963|076|H|remember, take it at the same time each day.||
0963|077|H|   Do not increase your dose or use this drug more often or for||
0963|078|H|longer than prescribed. Your condition will not improve any||
0963|079|H|faster, and your risk of side effects will increase.||
0963|080|H|   Keep taking this medication even if you feel well. Do not stop||
0963|081|H|taking this medication without consulting your doctor. Some||
0963|082|H|conditions may become worse when this drug is suddenly stopped.||
0963|083|H|Also, you may experience symptoms such as trouble sleeping,||
0963|084|H|nausea, headache, diarrhea, irritability. Your dose may need to||
0963|085|H|be gradually decreased to reduce side effects. Report any new or||
0963|086|H|worsening symptoms right away.||
0963|087|H|   Tell your doctor if your condition lasts or gets worse.||
0963|088|B|||
0963|089|S|SIDE EFFECTS:  See also Warning section.||
0963|090|S|   Constipation, drowsiness, upset stomach, tiredness, weight||
0963|091|S|gain, blurred vision, or dry mouth may occur. If any of these||
0963|092|S|effects last or get worse, tell your doctor promptly.||
0963|093|S|   Dizziness or lightheadedness may occur, especially when you||
0963|094|S|first start or increase your dose of this drug. Dizziness and||
0963|095|S|lightheadedness can increase the risk of falling. Get up slowly||
0963|096|S|when rising from a sitting or lying position.||
0963|097|S|   Remember that this medication has been prescribed because your||
0963|098|S|doctor has judged that the benefit to you is greater than the||
0963|099|S|risk of side effects. Many people using this medication do not||
0963|100|S|have serious side effects.||
0963|101|S|   Tell your doctor right away if you have any serious side||
0963|102|S|effects, including: nausea/vomiting that doesn't stop,||
0963|103|S|constipation with abdominal pain that doesn't go away,||
0963|104|S|restlessness/constant need to move, shaking (tremor), mental/mood||
0963|105|S|changes (such as increased anxiety, depression, thoughts of||
0963|106|S|suicide), difficulty swallowing, loss of appetite, yellowing||
0963|107|S|eyes/skin, interrupted breathing during sleep, trouble urinating.||
0963|108|S|   Get medical help right away if you have any very serious side||
0963|109|S|effects, including: fainting, seizure, severe dizziness.||
0963|110|S|   This medication may rarely make your blood sugar rise, which||
0963|111|S|can cause or worsen diabetes. Tell your doctor right away if you||
0963|112|S|have symptoms of high blood sugar such as increased||
0963|113|S|thirst/urination. If you already have diabetes, check your blood||
0963|114|S|sugar regularly as directed and share the results with your||
0963|115|S|doctor. Your doctor may need to adjust your diabetes medication,||
0963|116|S|exercise program, or diet.||
0963|117|S|   This drug may also cause significant weight gain and a rise in||
0963|118|S|your blood cholesterol (or triglyceride) levels. These effects,||
0963|119|S|along with diabetes, may increase your risk for developing heart||
0963|120|S|disease. Discuss the risks and benefits of treatment with your||
0963|121|S|doctor. (See also Notes section.)||
0963|122|S|   Quetiapine may rarely cause a condition known as tardive||
0963|123|S|dyskinesia. In some cases, this condition may be permanent. Tell||
0963|124|S|your doctor right away if you develop any unusual/uncontrolled||
0963|125|S|movements (especially of the face, lips, mouth, tongue, arms or||
0963|126|S|legs).||
0963|127|S|   This medication may rarely cause a very serious condition||
0963|128|S|called neuroleptic malignant syndrome (NMS). Get medical help||
0963|129|S|right away if you have any of the following symptoms: fever,||
0963|130|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
0963|131|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
0963|132|S|signs of kidney problems (such as change in the amount of urine).||
0963|133|S|   Quetiapine may increase a certain natural substance||
0963|134|S|(prolactin) made by your body. For females, this increase in||
0963|135|S|prolactin may result in unwanted breast milk, missed/stopped||
0963|136|S|periods, or difficulty becoming pregnant. For males, it may||
0963|137|S|result in decreased sexual ability, inability to produce sperm,||
0963|138|S|or enlarged breasts. If you develop any of these symptoms, tell||
0963|139|S|your doctor right away.||
0963|140|S|   Rarely, males may have a painful or prolonged erection lasting||
0963|141|S|4 or more hours. If this occurs, stop using this drug and get||
0963|142|S|medical help right away, or permanent problems could occur.||
0963|143|S|   A very serious allergic reaction to this drug is rare.||
0963|144|S|However, get medical help right away if you notice any symptoms||
0963|145|S|of a serious allergic reaction, including: fever, swollen lymph||
0963|146|S|nodes, rash, itching/swelling (especially of the||
0963|147|S|face/tongue/throat), severe dizziness, trouble breathing.||
0963|148|S|   This is not a complete list of possible side effects. If you||
0963|149|S|notice other effects not listed above, contact your doctor or||
0963|150|S|pharmacist.||
0963|151|S|   In the US -||
0963|152|S|   Call your doctor for medical advice about side effects. You||
0963|153|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0963|154|S|www.fda.gov/medwatch.||
0963|155|S|   In Canada - Call your doctor for medical advice about side||
0963|156|S|effects. You may report side effects to Health Canada at||
0963|157|S|1-866-234-2345.||
0963|158|B|||
0963|159|P|PRECAUTIONS:  Before taking quetiapine, tell your doctor or||
0963|160|P|pharmacist if you are allergic to it; or if you have any other||
0963|161|P|allergies. This product may contain inactive ingredients, which||
0963|162|P|can cause allergic reactions or other problems. Talk to your||
0963|163|P|pharmacist for more details.||
0963|164|P|   Before using this medication, tell your doctor or pharmacist||
0963|165|P|your medical history, especially of: eye cataracts, liver||
0963|166|P|disease, low white blood cell count (including history of low||
0963|167|P|white blood cell count caused by medications), seizure disorder,||
0963|168|P|trouble swallowing, thyroid problems, stomach/intestinal blockage||
0963|169|P|(such as severe constipation, bowel obstruction),||
0963|170|P|stomach/intestines that are not moving (such as ileus), personal||
0963|171|P|or family history of diabetes, personal or family history of a||
0963|172|P|substance use disorder (such as overuse of or addiction to||
0963|173|P|drugs/alcohol), heart disease, high blood pressure, high||
0963|174|P|cholesterol/triglyceride levels, breathing trouble during sleep||
0963|175|P|(sleep apnea), difficulty urinating (for example, due to enlarged||
0963|176|P|prostate).||
0963|177|P|   This drug may make you dizzy or drowsy or blur your vision.||
0963|178|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0963|179|P|drowsy. Do not drive, use machinery, or do anything that needs||
0963|180|P|alertness or clear vision until you can do it safely. Avoid||
0963|181|P|alcoholic beverages. Talk to your doctor if you are using||
0963|182|P|marijuana (cannabis).||
0963|183|P|   Quetiapine may cause a condition that affects the heart rhythm||
0963|184|P|(QT prolongation). QT prolongation can rarely cause serious||
0963|185|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0963|186|P|as severe dizziness, fainting) that need medical attention right||
0963|187|P|away.||
0963|188|P|   The risk of QT prolongation may be increased if you have||
0963|189|P|certain medical conditions or are taking other drugs that may||
0963|190|P|cause QT prolongation. Before using quetiapine, tell your doctor||
0963|191|P|or pharmacist of all the drugs you take and if you have any of||
0963|192|P|the following conditions: certain heart problems (heart failure,||
0963|193|P|slow heartbeat, QT prolongation in the EKG), family history of||
0963|194|P|certain heart problems (QT prolongation in the EKG, sudden||
0963|195|P|cardiac death).||
0963|196|P|   Low levels of potassium or magnesium in the blood may also||
0963|197|P|increase your risk of QT prolongation. This risk may increase if||
0963|198|P|you use certain drugs (such as diuretics/"water pills") or if you||
0963|199|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0963|200|P|Talk to your doctor about using quetiapine safely.||
0963|201|P|   This medication may make you sweat less, making you more||
0963|202|P|likely to get heat stroke. Avoid doing things that may cause you||
0963|203|P|to overheat, such as hard work or exercise in hot weather, or||
0963|204|P|using hot tubs. When the weather is hot, drink a lot of fluids||
0963|205|P|and dress lightly. If you overheat, quickly look for a place to||
0963|206|P|cool down and rest. Get medical help right away if you have a||
0963|207|P|fever that does not go away, mental/mood changes, headache, or||
0963|208|P|dizziness.||
0963|209|P|   Before having surgery, tell your doctor or dentist about all||
0963|210|P|the products you use (including prescription drugs,||
0963|211|P|nonprescription drugs, and herbal products).||
0963|212|P|   Children may be at higher risk for certain side effects while||
0963|213|P|taking this medication, such as increased blood pressure or||
0963|214|P|increased prolactin (see also Side Effects section). Talk with||
0963|215|P|the doctor about the risks and benefits.||
0963|216|P|   Older adults may be more sensitive to the side effects of this||
0963|217|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
0963|218|P|prolongation (see above). Drowsiness, dizziness, and||
0963|219|P|lightheadedness can increase the risk of falling.||
0963|220|P|   During pregnancy, this medication should be used only when||
0963|221|P|clearly needed. Babies born to mothers who have used this drug||
0963|222|P|during the last 3 months of pregnancy may rarely develop symptoms||
0963|223|P|including muscle stiffness or shakiness, drowsiness,||
0963|224|P|feeding/breathing difficulties, or constant crying. If you notice||
0963|225|P|any of these symptoms in your newborn especially during their||
0963|226|P|first month, tell the doctor right away.||
0963|227|P|   Since untreated mental/mood problems (such as schizophrenia,||
0963|228|P|bipolar disorder, depression) can be a serious condition, do not||
0963|229|P|stop taking this medication unless directed by your doctor. If||
0963|230|P|you are planning pregnancy, become pregnant, or think you may be||
0963|231|P|pregnant, immediately discuss with your doctor the benefits and||
0963|232|P|risks of using this medication during pregnancy.||
0963|233|P|   This medication passes into breast milk and may have||
0963|234|P|undesirable effects on a nursing infant. Tell the doctor right||
0963|235|P|away if your baby develops symptoms such as muscle stiffness or||
0963|236|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
0963|237|P|your doctor before breastfeeding.||
0963|238|B|||
0963|239|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0963|240|I|medications work or increase your risk for serious side effects.||
0963|241|I|This document does not contain all possible drug interactions.||
0963|242|I|Keep a list of all the products you use (including||
0963|243|I|prescription/nonprescription drugs and herbal products) and share||
0963|244|I|it with your doctor and pharmacist. Do not start, stop, or change||
0963|245|I|the dosage of any medicines without your doctor's approval.||
0963|246|I|   Many drugs besides quetiapine may affect the heart rhythm (QT||
0963|247|I|prolongation), including amiodarone, moxifloxacin, procainamide,||
0963|248|I|quinidine, sotalol, thioridazine, among others.||
0963|249|I|   Other medications can affect the removal of quetiapine from||
0963|250|I|your body, which may affect how quetiapine works. Examples||
0963|251|I|include azole antifungals (such as itraconazole, ketoconazole),||
0963|252|I|drugs used to treat seizures (such as phenytoin), among others.||
0963|253|I|   Tell your doctor or pharmacist if you are taking other||
0963|254|I|products that cause drowsiness such as opioid pain or cough||
0963|255|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0963|256|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0963|257|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0963|258|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
0963|259|I|diphenhydramine).||
0963|260|I|   Check the labels on all your medicines (such as allergy or||
0963|261|I|cough-and-cold products) because they may contain ingredients||
0963|262|I|that cause drowsiness. Ask your pharmacist about using those||
0963|263|I|products safely.||
0963|264|I|   This medication may interfere with certain lab tests (such as||
0963|265|I|urine tests), possibly causing false test results. Make sure lab||
0963|266|I|personnel and all your doctors know you use this drug.||
0963|267|B|||
0963|268|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0963|269|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0963|270|O|poison control center right away. US residents can call||
0963|271|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0963|272|O|Symptoms of overdose may include: severe drowsiness, loss of||
0963|273|O|consciousness.||
0963|274|B|||
0963|275|N|NOTES:  Do not share this medication with others.||
0963|276|N|   Lab and/or medical tests (such as blood sugar, blood pressure,||
0963|277|N|cholesterol levels, eye exams, weight, blood counts) should be||
0963|278|N|done before you start taking this medication and while you are||
0963|279|N|taking it. Keep all medical and lab appointments. Consult your||
0963|280|N|doctor for more details.||
0963|281|B|||
0963|282|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0963|283|D|remember. If it is near the time of the next dose, skip the||
0963|284|D|missed dose. Take your next dose at the regular time. Do not||
0963|285|D|double the dose to catch up.||
0963|286|B|||
0963|287|R|STORAGE:  Store at room temperature away from light and moisture.||
0963|288|R|Do not store in the bathroom. Keep all medications away from||
0963|289|R|children and pets.||
0963|290|R|   Do not flush medications down the toilet or pour them into a||
0963|291|R|drain unless instructed to do so. Properly discard this product||
0963|292|R|when it is expired or no longer needed. Consult your pharmacist||
0963|293|R|or local waste disposal company.||
0963|294|B|||
0963|295|A|Information last revised May 2024.||
0963|296|A|Copyright(c) 2025 First Databank, Inc.||
0963|297|B|||
0964|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0964|002|Z|does NOT have all possible information about this product. This||
0964|003|Z|information does not assure that this product is safe, effective,||
0964|004|Z|or appropriate for you. This information is not individual||
0964|005|Z|medical advice and does not substitute for the advice of your||
0964|006|Z|health care professional. Always ask your health care||
0964|007|Z|professional for complete information about this product and your||
0964|008|Z|specific health needs.||
0964|009|B|||
0964|010|T|RAMIPRIL/HYDROCHLOROTHIAZIDE - ORAL||
0964|011|F|(RAM-ih-prill/HYE-droe-KLOR-oh-THYE-a-zide)||
0964|012|B|||
0964|013|W|WARNING:  This medication can cause serious (possibly fatal) harm||
0964|014|W|to an unborn baby if used during pregnancy. It is important to||
0964|015|W|prevent pregnancy while taking this medication. Consult your||
0964|016|W|doctor for more details and to discuss reliable forms of birth||
0964|017|W|control. If you are planning pregnancy, become pregnant, or think||
0964|018|W|you may be pregnant, tell your doctor right away.||
0964|019|B|||
0964|020|U|USES:  This medication is used to treat high blood pressure||
0964|021|U|(hypertension). Lowering high blood pressure helps prevent||
0964|022|U|strokes, heart attacks, and kidney problems.||
0964|023|U|   This product contains 2 medications, ramipril and||
0964|024|U|hydrochlorothiazide. Ramipril is called an ACE inhibitor and||
0964|025|U|works by relaxing blood vessels so that blood can flow through||
0964|026|U|the body more easily. Hydrochlorothiazide (or "The thiazide||
0964|027|U|diuretic") increases the amount of urine you make, removing extra||
0964|028|U|water and salt from your body. It also helps to relax the blood||
0964|029|U|vessels so that blood can flow through the body more easily.||
0964|030|U|   These medications are used together when one drug is not||
0964|031|U|controlling your blood pressure. Your doctor may direct you to||
0964|032|U|start taking the individual medications first, and then switch||
0964|033|U|you to this combination product if it is the best dose||
0964|034|U|combination for you.||
0964|035|B|||
0964|036|V|OTHER USES:  This section contains uses of this drug that are not||
0964|037|V|listed in the approved professional labeling for the drug but||
0964|038|V|that may be prescribed by your health care professional. Use this||
0964|039|V|drug for a condition that is listed in this section only if it||
0964|040|V|has been so prescribed by your health care professional.||
0964|041|V|   This drug may also be used for heart failure.||
0964|042|B|||
0964|043|H|HOW TO USE:  Take this medication by mouth with or without food||
0964|044|H|as directed by your doctor, usually once daily. Do not chew or||
0964|045|H|crush the tablet. If you take this drug too close to bedtime, you||
0964|046|H|may need to wake up to urinate. It is best to take this||
0964|047|H|medication when you first wake up for the day. Consult your||
0964|048|H|doctor or pharmacist if you have questions about your dosing||
0964|049|H|schedule.||
0964|050|H|   If you also take certain drugs to lower your cholesterol (bile||
0964|051|H|acid-binding resins such as cholestyramine or colestipol), take||
0964|052|H|this product at least 4 hours before or at least 4 to 6 hours||
0964|053|H|after these medications.||
0964|054|H|   The dosage is based on your medical condition and response to||
0964|055|H|treatment.||
0964|056|H|   Use this medication regularly in order to get the most benefit||
0964|057|H|from it. To help you remember, take it at the same time each day.||
0964|058|H|Keep taking this medication even if you feel well. Most people||
0964|059|H|with high blood pressure do not feel sick. It may take up to||
0964|060|H|several weeks before you get the full benefit of this drug.||
0964|061|H|   Do not stop taking this medication without first consulting||
0964|062|H|your doctor. Some conditions may become worse when the drug is||
0964|063|H|abruptly stopped. Your dose may need to be gradually decreased.||
0964|064|H|   Tell your doctor if your condition does not get better or if||
0964|065|H|it gets worse (your blood pressure readings remain high or||
0964|066|H|increase).||
0964|067|B|||
0964|068|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
0964|069|S|body adjusts to the medication. Headache or dry cough may also||
0964|070|S|occur. If any of these effects last or get worse, tell your||
0964|071|S|doctor or pharmacist promptly.||
0964|072|S|   To reduce the risk of dizziness and lightheadedness, get up||
0964|073|S|slowly when rising from a sitting or lying position.||
0964|074|S|   Remember that this medication has been prescribed because your||
0964|075|S|doctor has judged that the benefit to you is greater than the||
0964|076|S|risk of side effects. Many people using this medication do not||
0964|077|S|have serious side effects.||
0964|078|S|   This product may cause dehydration and electrolyte imbalance.||
0964|079|S|Tell your doctor right away if you have any symptoms of||
0964|080|S|dehydration or electrolyte imbalance, including unusual dry||
0964|081|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
0964|082|S|heartbeat, or confusion.||
0964|083|S|   Tell your doctor right away if you have any serious side||
0964|084|S|effects, including: fainting, swelling hands/feet, fast/irregular||
0964|085|S|heartbeat, mental/mood changes (such as depression, nervousness),||
0964|086|S|numbness/tingling of the hands/feet, muscle/joint aches, decrease||
0964|087|S|in vision, eye pain, easy bruising/bleeding, seizures, signs of||
0964|088|S|kidney problems (such as change in the amount of urine).||
0964|089|S|   This drug may rarely cause serious (possibly fatal) liver||
0964|090|S|problems. Get medical help right away if you have any symptoms of||
0964|091|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
0964|092|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
0964|093|S|urine.||
0964|094|S|   A very serious allergic reaction to this drug is rare.||
0964|095|S|However, get medical help right away if you notice any symptoms||
0964|096|S|of a serious allergic reaction, including: rash, itching/swelling||
0964|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0964|098|S|breathing.||
0964|099|S|   This is not a complete list of possible side effects. If you||
0964|100|S|notice other effects not listed above, contact your doctor or||
0964|101|S|pharmacist.||
0964|102|S|   In the US -||
0964|103|S|   Call your doctor for medical advice about side effects. You||
0964|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0964|105|S|www.fda.gov/medwatch.||
0964|106|S|   In Canada - Call your doctor for medical advice about side||
0964|107|S|effects. You may report side effects to Health Canada at||
0964|108|S|1-866-234-2345.||
0964|109|B|||
0964|110|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0964|111|P|pharmacist if you are allergic to either ramipril or||
0964|112|P|hydrochlorothiazide; or to other ACE inhibitors (such as||
0964|113|P|captopril, lisinopril); or to other thiazides (such as||
0964|114|P|chlorothiazide); or if you have any other allergies. This product||
0964|115|P|may contain inactive ingredients, which can cause allergic||
0964|116|P|reactions or other problems. Talk to your pharmacist for more||
0964|117|P|details.||
0964|118|P|   Before using this medication, tell your doctor or pharmacist||
0964|119|P|your medical history, especially of: a history of an allergic||
0964|120|P|reaction that included swelling of the face/lips/tongue/throat||
0964|121|P|(angioedema), kidney disease (such as renal artery stenosis),||
0964|122|P|untreated mineral imbalance (such as high calcium, high/low||
0964|123|P|potassium, low magnesium), dehydration, blood exchange procedures||
0964|124|P|(such as apheresis, dialysis), liver disease, gout, lupus, skin||
0964|125|P|cancer.||
0964|126|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0964|127|P|can make you more dizzy. Do not drive, use machinery, or do||
0964|128|P|anything that needs alertness until you can do it safely. Limit||
0964|129|P|alcoholic beverages. Talk to your doctor if you are using||
0964|130|P|marijuana (cannabis).||
0964|131|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0964|132|P|and cause you to feel lightheaded. Tell your doctor if you have||
0964|133|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0964|134|P|of fluids unless your doctor tells you not to.||
0964|135|P|   Before having surgery, tell your doctor or dentist about all||
0964|136|P|the products you use (including prescription drugs,||
0964|137|P|nonprescription drugs, and herbal products).||
0964|138|P|   This medication may make you more sensitive to the sun. It may||
0964|139|P|also increase your risk for skin cancer, especially if you take||
0964|140|P|it for a long time. Limit your time in the sun. Avoid tanning||
0964|141|P|booths and sunlamps. Use sunscreen and wear protective clothing||
0964|142|P|when outdoors. Tell your doctor right away if you get sunburned,||
0964|143|P|have skin blisters/redness, or notice new or changed moles/skin||
0964|144|P|lesions.||
0964|145|P|   This product may affect your potassium levels. Before using||
0964|146|P|potassium supplements or salt substitutes that contain potassium,||
0964|147|P|consult your doctor or pharmacist.||
0964|148|P|   If you have diabetes, this product may change your blood||
0964|149|P|sugar. Check your blood sugar regularly as directed and share the||
0964|150|P|results with your doctor. Tell your doctor right away if you have||
0964|151|P|symptoms of high blood sugar such as increased thirst/urination,||
0964|152|P|or signs of low blood sugar such as sudden sweating, shaking,||
0964|153|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
0964|154|P|hands/feet. Your doctor may need to adjust your diabetes||
0964|155|P|medication, exercise program, or diet.||
0964|156|P|   Older adults may be more sensitive to the side effects of this||
0964|157|P|drug, especially dizziness and change in the amount of urine||
0964|158|P|(kidney problems).||
0964|159|P|   Tell your doctor if you are pregnant or plan to become||
0964|160|P|pregnant. You should not become pregnant while using this||
0964|161|P|product. Ramipril may harm an unborn baby. If you become||
0964|162|P|pregnant, talk to your doctor right away about the risks and||
0964|163|P|benefits of this medication. (See also Warning section.)||
0964|164|P|   This medication passes into breast milk and may have||
0964|165|P|undesirable effects on a nursing infant. Consult your doctor||
0964|166|P|before breastfeeding.||
0964|167|B|||
0964|168|I|DRUG INTERACTIONS:  See also Precautions section.||
0964|169|I|   Drug interactions may change how your medications work or||
0964|170|I|increase your risk for serious side effects. This document does||
0964|171|I|not contain all possible drug interactions. Keep a list of all||
0964|172|I|the products you use (including prescription/nonprescription||
0964|173|I|drugs and herbal products) and share it with your doctor and||
0964|174|I|pharmacist. Do not start, stop, or change the dosage of any||
0964|175|I|medicines without your doctor's approval.||
0964|176|I|   Some products that may interact with this drug are: aliskiren,||
0964|177|I|alpha blockers (such as prazosin, terazosin), dofetilide, drugs||
0964|178|I|that may increase the level of potassium in the blood (such as||
0964|179|I|ARBs including losartan/valsartan, birth control pills containing||
0964|180|I|drospirenone), certain drugs that weaken the immune||
0964|181|I|system/increase the risk of infection (such as everolimus,||
0964|182|I|sirolimus), lithium, probenecid, telmisartan, gold injections,||
0964|183|I|sacubitril.||
0964|184|I|   Some products have ingredients that could raise your blood||
0964|185|I|pressure. Tell your pharmacist what products you are using, and||
0964|186|I|ask how to use them safely (especially cough-and-cold products,||
0964|187|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0964|188|I|   A very serious reaction may occur if you are getting||
0964|189|I|injections for bee/wasp sting allergy (desensitization) and are||
0964|190|I|also taking ramipril with hydrochlorothiazide. Make sure all your||
0964|191|I|doctors know which medicines you are using.||
0964|192|I|   This medication may interfere with certain lab tests (such as||
0964|193|I|parathyroid, protein-bound iodide, tyramine, and phentolamine||
0964|194|I|tests), possibly causing false test results. Make sure lab||
0964|195|I|personnel and all your doctors know you use this drug.||
0964|196|B|||
0964|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0964|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0964|199|O|poison control center right away. US residents can call||
0964|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0964|201|O|Symptoms of overdose may include: severe dizziness, fainting,||
0964|202|O|irregular heartbeat, seizures.||
0964|203|B|||
0964|204|N|NOTES:  Do not share this medication with others.||
0964|205|N|   Lifestyle changes such as stress reduction programs, exercise,||
0964|206|N|and dietary changes may increase the effectiveness of this||
0964|207|N|medicine. Talk to your doctor or pharmacist about lifestyle||
0964|208|N|changes that might benefit you.||
0964|209|N|   Lab and/or medical tests (such as complete blood count, blood||
0964|210|N|sodium and potassium levels, kidney/liver function, skin exams,||
0964|211|N|cholesterol levels) should be done while you are taking this||
0964|212|N|medication. Keep all medical and lab appointments. Consult your||
0964|213|N|doctor for more details.||
0964|214|N|   Check your blood pressure regularly while taking this||
0964|215|N|medication, especially when you first start this drug or when||
0964|216|N|your dose is changed. Learn how to monitor your own blood||
0964|217|N|pressure at home, and share the results with your doctor.||
0964|218|B|||
0964|219|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0964|220|D|remember. If it is near the time of the next dose, skip the||
0964|221|D|missed dose. Take your next dose at the regular time. Do not||
0964|222|D|double the dose to catch up.||
0964|223|B|||
0964|224|R|STORAGE:  Store at room temperature away from light and moisture.||
0964|225|R|Do not store in the bathroom. Keep all medications away from||
0964|226|R|children and pets.||
0964|227|R|   Do not flush medications down the toilet or pour them into a||
0964|228|R|drain unless instructed to do so. Properly discard this product||
0964|229|R|when it is expired or no longer needed. Consult your pharmacist||
0964|230|R|or local waste disposal company.||
0964|231|B|||
0964|232|A|Information last revised April 2025.||
0964|233|A|Copyright(c) 2025 First Databank, Inc.||
0964|234|B|||
0967|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0967|002|Z|does NOT have all possible information about this product. This||
0967|003|Z|information does not assure that this product is safe, effective,||
0967|004|Z|or appropriate for you. This information is not individual||
0967|005|Z|medical advice and does not substitute for the advice of your||
0967|006|Z|health care professional. Always ask your health care||
0967|007|Z|professional for complete information about this product and your||
0967|008|Z|specific health needs.||
0967|009|B|||
0967|010|T|LEVONORGESTREL/ETHINYL ESTRADIOL NON-CYCLIC CONTRACEPTIVE - ORAL||
0967|011|F|(LEE-voe-nor-JES-trel/ETH-i-nil ES-tra-DYE-ol)||
0967|012|B|||
0967|013|C|COMMON BRAND NAME(S): Amethyst, Lybrel||
0967|014|B|||
0967|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
0967|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
0967|017|W|stroke, heart attack, blood clots, and high blood pressure from||
0967|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
0967|019|W|of these serious problems increases with age and with the number||
0967|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
0967|021|B|||
0967|022|U|USES:  This combination hormone medication is used to prevent||
0967|023|U|pregnancy. It contains 2 hormones: levonorgestrel (a progestin)||
0967|024|U|and ethinyl estradiol (an estrogen).||
0967|025|U|   Besides preventing pregnancy, birth control pills may make||
0967|026|U|your periods more regular, decrease blood loss and painful||
0967|027|U|periods, decrease your risk of ovarian cysts, and also treat||
0967|028|U|acne.||
0967|029|U|   This medication does not protect against sexually transmitted||
0967|030|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
0967|031|U|an effective barrier method (latex or polyurethane condom/dental||
0967|032|U|dams) during sexual activity will help to decrease your risk of||
0967|033|U|infection.||
0967|034|B|||
0967|035|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0967|036|H|your pharmacist before you start using this product and each time||
0967|037|H|you get a refill. The leaflet contains very important information||
0967|038|H|on when to take your pills and what to do if you miss a dose. If||
0967|039|H|you have any questions, ask your doctor or pharmacist.||
0967|040|H|   Take this medication by mouth as directed by your doctor,||
0967|041|H|usually once daily. Pick a time of day that is easy for you to||
0967|042|H|remember, and take your pill at the same time each day.||
0967|043|H|   It is very important to keep taking this medication exactly as||
0967|044|H|prescribed by your doctor. Follow the package instructions to||
0967|045|H|find the first tablet, start with the first tablet in the pack,||
0967|046|H|and take them in the correct order. Do not skip any doses.||
0967|047|H|Pregnancy is more likely if you miss pills, start a new pack||
0967|048|H|late, or take your pill at a different time of the day than||
0967|049|H|usual.||
0967|050|H|   Taking this medication after your evening meal or at bedtime||
0967|051|H|may help if you have stomach upset or nausea with the medication.||
0967|052|H|You may choose to take this medication at another time of day||
0967|053|H|that is easier for you to remember. No matter what dosing||
0967|054|H|schedule you use, it is very important that you take this||
0967|055|H|medication at the same time each day, 24 hours apart.||
0967|056|H|   If you have vomiting or diarrhea within 4 hours after taking||
0967|057|H|your tablet, read the Patient Information Leaflet section titled||
0967|058|H|"What to Do if You Miss Tablets." Follow the instructions as if||
0967|059|H|you had missed your dose because vomiting/diarrhea can stop the||
0967|060|H|tablet from working.||
0967|061|H|   Your pill pack contains 28 pills with active medication. Take||
0967|062|H|one active pill (with hormones) once daily for 28 days in a row.||
0967|063|H|After taking the last tablet in your old pack, start a new pack||
0967|064|H|the next day. There is no break between packs, and there are no||
0967|065|H|"reminder" tablets (tablets without medication). Most women do||
0967|066|H|not have regular periods while taking this medication. You may||
0967|067|H|have some bleeding or spotting. If this happens, do not stop||
0967|068|H|taking your pills.||
0967|069|H|   If this is the first time you are using this medication and||
0967|070|H|you are not switching from another form of hormonal birth control||
0967|071|H|(such as patch, other birth control pills), take the first tablet||
0967|072|H|in the pack on the first day of your period. If your doctor||
0967|073|H|directs you to start this medication on any other day, use a||
0967|074|H|backup form of non-hormonal birth control (such as condoms,||
0967|075|H|spermicide) for the first 7 days to prevent pregnancy until the||
0967|076|H|medication has enough time to work. If you start on the first day||
0967|077|H|of your period, you do not need to use backup birth control the||
0967|078|H|first week.||
0967|079|H|   Ask your doctor or pharmacist for information about how to||
0967|080|H|switch from other forms of hormonal birth control (such as patch,||
0967|081|H|other birth control pills) to this product. If any information is||
0967|082|H|unclear, consult the Patient Information Leaflet or your doctor||
0967|083|H|or pharmacist.||
0967|084|B|||
0967|085|S|SIDE EFFECTS:  Nausea, vomiting, headache, abdominal||
0967|086|S|cramps/bloating, breast tenderness, swelling of the ankles/feet||
0967|087|S|(retaining fluid), or weight change may occur. If any of these||
0967|088|S|effects last or get worse, tell your doctor or pharmacist||
0967|089|S|promptly.||
0967|090|S|   Many women will not have regular periods while taking this||
0967|091|S|medication. This is normal. Vaginal bleeding/spotting is likely||
0967|092|S|to occur, especially during the first few months of use. If||
0967|093|S|bleeding is unusually heavy or lasts for more than 7 days in a||
0967|094|S|row, contact your doctor promptly.||
0967|095|S|   Remember that this medication has been prescribed because your||
0967|096|S|doctor has judged that the benefit to you is greater than the||
0967|097|S|risk of side effects. Many people using this medication do not||
0967|098|S|have serious side effects.||
0967|099|S|   This medication may raise your blood pressure. Check your||
0967|100|S|blood pressure regularly and tell your doctor if the results are||
0967|101|S|high.||
0967|102|S|   Tell your doctor right away if you have any serious side||
0967|103|S|effects, including: lumps in the breast, mental/mood changes||
0967|104|S|(such as new/worsening depression), unusual changes in vaginal||
0967|105|S|bleeding (such as continuous spotting, sudden heavy bleeding),||
0967|106|S|severe pain in the stomach/abdomen/pelvis, dark urine, yellowing||
0967|107|S|eyes/skin.||
0967|108|S|   This medication may rarely cause serious (sometimes fatal)||
0967|109|S|problems from blood clots (such as heart attack, stroke, blood||
0967|110|S|clots in the lungs or legs). Get medical help right away if you||
0967|111|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
0967|112|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
0967|113|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
0967|114|S|trouble speaking, weakness on one side of the body, sudden vision||
0967|115|S|changes.||
0967|116|S|   A very serious allergic reaction to this drug is rare.||
0967|117|S|However, get medical help right away if you notice any symptoms||
0967|118|S|of a serious allergic reaction, including: rash, itching/swelling||
0967|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0967|120|S|breathing.||
0967|121|S|   This is not a complete list of possible side effects. If you||
0967|122|S|notice other effects not listed above, contact your doctor or||
0967|123|S|pharmacist.||
0967|124|S|   In the US -||
0967|125|S|   Call your doctor for medical advice about side effects. You||
0967|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0967|127|S|www.fda.gov/medwatch.||
0967|128|S|   In Canada - Call your doctor for medical advice about side||
0967|129|S|effects. You may report side effects to Health Canada at||
0967|130|S|1-866-234-2345.||
0967|131|B|||
0967|132|P|PRECAUTIONS:  See also Warning section.||
0967|133|P|   Before taking levonorgestrel/ethinyl estradiol, tell your||
0967|134|P|doctor or pharmacist if you are allergic to it; or to any||
0967|135|P|estrogens (such as ethinyl estradiol, mestranol); or to any||
0967|136|P|progestins (such as norethindrone, desogestrel); or if you have||
0967|137|P|any other allergies. This product may contain inactive||
0967|138|P|ingredients, which can cause allergic reactions or other||
0967|139|P|problems. Talk to your pharmacist for more details.||
0967|140|P|   Before using this medication, tell your doctor or pharmacist||
0967|141|P|your medical history, especially of: blood clots (for example, in||
0967|142|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
0967|143|P|C or protein S deficiency), high blood pressure, abnormal breast||
0967|144|P|exam, cancer (especially endometrial and breast cancer), high||
0967|145|P|cholesterol or triglyceride (blood fat) levels, depression,||
0967|146|P|diabetes, family or personal history of a certain swelling||
0967|147|P|disorder (angioedema), gallbladder problems, severe||
0967|148|P|headaches/migraines, heart problems (such as heart valve disease,||
0967|149|P|irregular heartbeat, previous heart attack), history of yellowing||
0967|150|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
0967|151|P|birth control (such as pills, patch), kidney disease, liver||
0967|152|P|problems (including tumors), stroke, swelling (edema), thyroid||
0967|153|P|problems, unexplained vaginal bleeding, obesity.||
0967|154|P|   If you have diabetes, this medication may affect your blood||
0967|155|P|sugar. Check your blood sugar regularly as directed and share the||
0967|156|P|results with your doctor. Tell your doctor right away if you have||
0967|157|P|symptoms of high blood sugar such as increased thirst/urination.||
0967|158|P|Your doctor may need to adjust your diabetes medication, exercise||
0967|159|P|program, or diet.||
0967|160|P|   Tell your doctor if you just had or will be having surgery or||
0967|161|P|if you will be confined to a bed or chair for a long time (such||
0967|162|P|as a long plane flight). These conditions increase your risk of||
0967|163|P|getting blood clots, especially if you are using hormonal birth||
0967|164|P|control. You may need to stop this medication for a time or take||
0967|165|P|special precautions.||
0967|166|P|   Before having surgery, tell your doctor or dentist about all||
0967|167|P|the products you use (including prescription drugs,||
0967|168|P|nonprescription drugs, and herbal products).||
0967|169|P|   This medication may cause blotchy, dark areas on your face and||
0967|170|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
0967|171|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
0967|172|P|wear protective clothing when outdoors.||
0967|173|P|   If you are nearsighted or wear contact lenses, you may develop||
0967|174|P|vision problems or trouble wearing your contact lenses. Tell your||
0967|175|P|eye doctor if these problems occur.||
0967|176|P|   It may take longer for you to become pregnant after you stop||
0967|177|P|taking birth control pills. Consult your doctor for more||
0967|178|P|information.||
0967|179|P|   This medication should not be used during pregnancy. If you||
0967|180|P|become pregnant or think you may be pregnant, tell your doctor||
0967|181|P|right away. If you have just given birth or had a pregnancy loss||
0967|182|P|or abortion after the first 3 months, talk with your doctor about||
0967|183|P|reliable forms of birth control, and find out when it is safe to||
0967|184|P|start using birth control that contains a form of estrogen, such||
0967|185|P|as this medication.||
0967|186|P|   A small amount of this medication passes into breast milk and||
0967|187|P|may have undesirable effects on a nursing infant. Consult your||
0967|188|P|doctor before breastfeeding.||
0967|189|B|||
0967|190|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0967|191|I|medications work or increase your risk for serious side effects.||
0967|192|I|This document does not contain all possible drug interactions.||
0967|193|I|Keep a list of all the products you use (including||
0967|194|I|prescription/nonprescription drugs and herbal products) and share||
0967|195|I|it with your doctor and pharmacist. Do not start, stop, or change||
0967|196|I|the dosage of any medicines without your doctor's approval.||
0967|197|I|   Some products that may interact with this drug include:||
0967|198|I|aromatase inhibitors (such as anastrozole, exemestane),||
0967|199|I|fezolinetant, ospemifene, tamoxifen, tizanidine, tranexamic acid.||
0967|200|I|   Some drugs may cause hormonal birth control to work less well||
0967|201|I|by decreasing the amount of birth control hormones in your body.||
0967|202|I|This effect can result in pregnancy. Examples include||
0967|203|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
0967|204|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
0967|205|I|seizures (such as barbiturates, carbamazepine, felbamate,||
0967|206|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
0967|207|I|nevirapine), among others.||
0967|208|I|   Tell your doctor when you start any new drug, and discuss if||
0967|209|I|you should use reliable backup birth control. Also tell your||
0967|210|I|doctor if you have any new spotting or breakthrough bleeding,||
0967|211|I|because these may be signs that your birth control is not working||
0967|212|I|well.||
0967|213|I|   This medication may interfere with certain lab tests (such as||
0967|214|I|blood tests for clotting factors, thyroid), possibly causing||
0967|215|I|false test results. Make sure lab personnel and all your doctors||
0967|216|I|know you use this drug.||
0967|217|B|||
0967|218|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0967|219|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0967|220|O|poison control center right away. US residents can call||
0967|221|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0967|222|O|Symptoms of overdose may include: severe nausea and vomiting,||
0967|223|O|sudden/unusual vaginal bleeding.||
0967|224|B|||
0967|225|N|NOTES:  Do not share this medication with others.||
0967|226|N|   Regular complete physical exams which include lab and/or||
0967|227|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
0967|228|N|Pap smear) should be done while you are taking this medication.||
0967|229|N|Follow your doctor's instructions for examining your breasts, and||
0967|230|N|report any lumps right away. Keep all medical and lab||
0967|231|N|appointments. Consult your doctor for more details.||
0967|232|B|||
0967|233|D|MISSED DOSE:  Missed dose advice is different depending on the||
0967|234|D|brand used and the number of doses missed. Refer to the product||
0967|235|D|package information for advice on missed doses. You may need to||
0967|236|D|use backup birth control (such as condoms, spermicide) to prevent||
0967|237|D|pregnancy. Ask your doctor or pharmacist if you have any||
0967|238|D|questions.||
0967|239|D|   If you often forget to take the pill as directed, contact your||
0967|240|D|doctor to discuss switching to another form of birth control.||
0967|241|B|||
0967|242|R|STORAGE:  Store at room temperature away from light and moisture.||
0967|243|R|Do not store in the bathroom. Keep all medications away from||
0967|244|R|children and pets.||
0967|245|R|   Do not flush medications down the toilet or pour them into a||
0967|246|R|drain unless instructed to do so. Properly discard this product||
0967|247|R|when it is expired or no longer needed. Consult your pharmacist||
0967|248|R|or local waste disposal company.||
0967|249|B|||
0967|250|A|Information last revised October 2025.||
0967|251|A|Copyright(c) 2025 First Databank, Inc.||
0967|252|B|||
0968|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0968|002|Z|does NOT have all possible information about this product. This||
0968|003|Z|information does not assure that this product is safe, effective,||
0968|004|Z|or appropriate for you. This information is not individual||
0968|005|Z|medical advice and does not substitute for the advice of your||
0968|006|Z|health care professional. Always ask your health care||
0968|007|Z|professional for complete information about this product and your||
0968|008|Z|specific health needs.||
0968|009|B|||
0968|010|T|AMBRISENTAN - ORAL||
0968|011|F|(AM-bri-SEN-tan)||
0968|012|B|||
0968|013|C|COMMON BRAND NAME(S): Letairis||
0968|014|B|||
0968|015|W|WARNING:  This medication must not be used during pregnancy. It||
0968|016|W|may harm an unborn baby. It is important to prevent pregnancy||
0968|017|W|while taking this medication and for 1 month after treatment.||
0968|018|W|Female patients must use reliable birth control before starting||
0968|019|W|treatment, during treatment, and for 1 month after the last dose.||
0968|020|W|Ask your doctor which forms of birth control to use while taking||
0968|021|W|this medication. Female patients must take a pregnancy test||
0968|022|W|before starting treatment. If you become pregnant or think you||
0968|023|W|may be pregnant, tell your doctor right away.||
0968|024|B|||
0968|025|U|USES:  Ambrisentan is used to treat high blood pressure in the||
0968|026|U|lungs (pulmonary arterial hypertension). This condition is||
0968|027|U|thought to be caused by increased levels of a certain natural||
0968|028|U|substance (endothelin-1). This medication blocks the effects of||
0968|029|U|endothelin-1, thereby helping to decrease the blood pressure in||
0968|030|U|the lungs, slow the worsening of symptoms, and improve your||
0968|031|U|ability to exercise.||
0968|032|B|||
0968|033|H|HOW TO USE:  Read the Medication Guide provided by your||
0968|034|H|pharmacist before you start using ambrisentan and each time you||
0968|035|H|get a refill. If you have any questions, consult your doctor or||
0968|036|H|pharmacist.||
0968|037|H|   Take this medication by mouth with or without food as directed||
0968|038|H|by your doctor, usually once daily. Do not crush, chew, or break||
0968|039|H|the tablets.||
0968|040|H|   The dosage is based on your medical condition, response to||
0968|041|H|treatment, and other medications you may be taking. Be sure to||
0968|042|H|tell your doctor and pharmacist about all the products you use||
0968|043|H|(including prescription drugs, nonprescription drugs, and herbal||
0968|044|H|products).||
0968|045|H|   Use this medication regularly to get the most benefit from it.||
0968|046|H|To help you remember, take it at the same times each day.||
0968|047|H|   Do not stop taking this medication without consulting your||
0968|048|H|doctor. Some conditions may become worse when the drug is||
0968|049|H|suddenly stopped. Your dose may need to be gradually decreased.||
0968|050|H|   Since this drug can be absorbed through the skin and lungs and||
0968|051|H|may harm an unborn baby, women who are pregnant or who may become||
0968|052|H|pregnant should not handle this medication or breathe the dust||
0968|053|H|from the tablets.||
0968|054|H|   Tell your doctor if your condition lasts or gets worse.||
0968|055|B|||
0968|056|S|SIDE EFFECTS:  Stuffy nose, runny nose, or flushing may occur. If||
0968|057|S|any of these effects last or get worse, tell your doctor or||
0968|058|S|pharmacist promptly.||
0968|059|S|   Remember that this medication has been prescribed because your||
0968|060|S|doctor has judged that the benefit to you is greater than the||
0968|061|S|risk of side effects. Many people using this medication do not||
0968|062|S|have serious side effects.||
0968|063|S|   Tell your doctor right away if you have any serious side||
0968|064|S|effects, including: fast heartbeat, extreme tiredness, swelling||
0968|065|S|ankles/feet, sudden/unexplained weight gain.||
0968|066|S|   Other medications that are like ambrisentan may rarely cause||
0968|067|S|very serious liver problems. Tell your doctor right away if you||
0968|068|S|develop symptoms of liver disease, including: nausea/vomiting||
0968|069|S|that doesn't stop, loss of appetite, severe stomach/abdominal||
0968|070|S|pain, dark urine, yellowing eyes/skin.||
0968|071|S|   A very serious allergic reaction to this drug is rare.||
0968|072|S|However, get medical help right away if you notice any symptoms||
0968|073|S|of a serious allergic reaction, including: rash, itching/swelling||
0968|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0968|075|S|breathing.||
0968|076|S|   This is not a complete list of possible side effects. If you||
0968|077|S|notice other effects not listed above, contact your doctor or||
0968|078|S|pharmacist.||
0968|079|S|   In the US -||
0968|080|S|   Call your doctor for medical advice about side effects. You||
0968|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0968|082|S|www.fda.gov/medwatch.||
0968|083|S|   In Canada - Call your doctor for medical advice about side||
0968|084|S|effects. You may report side effects to Health Canada at||
0968|085|S|1-866-234-2345.||
0968|086|B|||
0968|087|P|PRECAUTIONS:  Before taking ambrisentan, tell your doctor or||
0968|088|P|pharmacist if you are allergic to it; or to other endothelin||
0968|089|P|receptor blockers (such as bosentan); or if you have any other||
0968|090|P|allergies. This product may contain inactive ingredients, which||
0968|091|P|can cause allergic reactions or other problems. Talk to your||
0968|092|P|pharmacist for more details.||
0968|093|P|   Before using this medication, tell your doctor or pharmacist||
0968|094|P|your medical history, especially of: liver disease, certain lung||
0968|095|P|conditions (pulmonary fibrosis), anemia.||
0968|096|P|   Before having surgery, tell your doctor or dentist about all||
0968|097|P|the products you use (including prescription drugs,||
0968|098|P|nonprescription drugs, and herbal products).||
0968|099|P|   Older adults may be at greater risk for swelling ankles/feet||
0968|100|P|while using this drug.||
0968|101|P|   This medication can affect fertility in males. Ask your doctor||
0968|102|P|for more details.||
0968|103|P|   Since this drug can be absorbed through the skin and lungs and||
0968|104|P|may harm an unborn baby, women who are pregnant or who may become||
0968|105|P|pregnant should not handle this medication or breathe the dust||
0968|106|P|from the tablets.||
0968|107|P|   This medication must not be used during pregnancy. It may harm||
0968|108|P|an unborn baby. Discuss the use of reliable forms of birth||
0968|109|P|control (such as condoms, birth control pills) before starting||
0968|110|P|treatment, during treatment, and for 1 month after the last dose.||
0968|111|P|If you become pregnant or think you may be pregnant, tell your||
0968|112|P|doctor right away. See also Warning section.||
0968|113|P|   It is unknown if this medication passes into breast milk.||
0968|114|P|Because of the possible risk to the infant, breastfeeding is not||
0968|115|P|recommended while using this medication. Consult your doctor||
0968|116|P|before breastfeeding.||
0968|117|B|||
0968|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0968|119|I|medications work or increase your risk for serious side effects.||
0968|120|I|This document does not contain all possible drug interactions.||
0968|121|I|Keep a list of all the products you use (including||
0968|122|I|prescription/nonprescription drugs and herbal products) and share||
0968|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
0968|124|I|the dosage of any medicines without your doctor's approval.||
0968|125|I|   A product that may interact with this drug is: sparsentan.||
0968|126|B|||
0968|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0968|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0968|129|O|poison control center right away. US residents can call||
0968|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0968|131|O|Symptoms of overdose may include: severe dizziness.||
0968|132|B|||
0968|133|N|NOTES:  Do not share this medication with others.||
0968|134|N|   Lab and/or medical tests (such as liver function, hemoglobin||
0968|135|N|level) will be done while you are taking this medication. Keep||
0968|136|N|all medical and lab appointments. Consult your doctor for more||
0968|137|N|details.||
0968|138|B|||
0968|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0968|140|D|remember. If it is near the time of the next dose, skip the||
0968|141|D|missed dose. Take your next dose at the regular time. Do not||
0968|142|D|double the dose to catch up.||
0968|143|B|||
0968|144|R|STORAGE:  Store at room temperature away from light and moisture.||
0968|145|R|Do not store in the bathroom. Keep all medications away from||
0968|146|R|children and pets.||
0968|147|R|   Do not flush medications down the toilet or pour them into a||
0968|148|R|drain unless instructed to do so. Properly discard this product||
0968|149|R|when it is expired or no longer needed. Consult your pharmacist||
0968|150|R|or local waste disposal company.||
0968|151|B|||
0968|152|A|Information last revised April 2025.||
0968|153|A|Copyright(c) 2025 First Databank, Inc.||
0968|154|B|||
0969|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0969|002|Z|does NOT have all possible information about this product. This||
0969|003|Z|information does not assure that this product is safe, effective,||
0969|004|Z|or appropriate for you. This information is not individual||
0969|005|Z|medical advice and does not substitute for the advice of your||
0969|006|Z|health care professional. Always ask your health care||
0969|007|Z|professional for complete information about this product and your||
0969|008|Z|specific health needs.||
0969|009|B|||
0969|010|T|PROTEIN C CONCENTRATE (HUMAN) - INJECTION||
0969|011|B|||
0969|012|C|COMMON BRAND NAME(S): Ceprotin||
0969|013|B|||
0969|014|U|USES:  Protein C is a natural substance in your body that helps||
0969|015|U|to decrease clotting in the blood vessels. This medication is||
0969|016|U|used to prevent and treat blood clots (such as venous thrombosis,||
0969|017|U|purpura fulminans) in people who are born with a severe lack of||
0969|018|U|protein C.||
0969|019|B|||
0969|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0969|021|H|from your pharmacist before you start using protein C concentrate||
0969|022|H|and each time you get a refill. If you have any questions, ask||
0969|023|H|your doctor or pharmacist.||
0969|024|H|   This medication is given by injection into a vein as directed||
0969|025|H|by your doctor. The dosage is based on your medical condition,||
0969|026|H|age, weight, lab tests, and response to treatment.||
0969|027|H|   Use this medication regularly to get the most benefit from it.||
0969|028|H|To help you remember, use it at the same times each day.||
0969|029|H|   Tell your doctor if your condition lasts or gets worse.||
0969|030|B|||
0969|031|S|SIDE EFFECTS:  Lightheadedness may occur. If this effect lasts or||
0969|032|S|gets worse, tell your doctor or pharmacist promptly.||
0969|033|S|   Remember that this medication has been prescribed because your||
0969|034|S|doctor has judged that the benefit to you is greater than the||
0969|035|S|risk of side effects. Many people using this medication do not||
0969|036|S|have serious side effects.||
0969|037|S|   Tell your doctor right away if you have any serious side||
0969|038|S|effects, including: easy or unusual bruising/bleeding, signs of||
0969|039|S|infection (such as sore throat that doesn't go away, fever,||
0969|040|S|chills), signs of liver disease (such as nausea/vomiting that||
0969|041|S|doesn't stop, dark urine, yellowing eyes/skin, severe||
0969|042|S|stomach/abdominal pain).||
0969|043|S|   A very serious allergic reaction to this drug is rare.||
0969|044|S|However, get medical help right away if you notice any symptoms||
0969|045|S|of a serious allergic reaction, including: rash, itching/swelling||
0969|046|S|(especially of the face/tongue/throat), severe dizziness, chest||
0969|047|S|pain, shortness of breath, trouble breathing.||
0969|048|S|   This is not a complete list of possible side effects. If you||
0969|049|S|notice other effects not listed above, contact the doctor.||
0969|050|S|   In the US -||
0969|051|S|   Call your doctor for medical advice about side effects. You||
0969|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0969|053|S|www.fda.gov/medwatch.||
0969|054|S|   In Canada - Call your doctor for medical advice about side||
0969|055|S|effects. You may report side effects to Health Canada at||
0969|056|S|1-866-234-2345.||
0969|057|B|||
0969|058|P|PRECAUTIONS:  Before using protein C concentrate, tell your||
0969|059|P|doctor or pharmacist if you are allergic to it; or to heparin; or||
0969|060|P|if you have any other allergies. This product may contain||
0969|061|P|inactive ingredients, which can cause allergic reactions or other||
0969|062|P|problems. Talk to your pharmacist for more details.||
0969|063|P|   Before using this medication, tell your doctor or pharmacist||
0969|064|P|your medical history, especially of: kidney disease, low platelet||
0969|065|P|counts after heparin treatment.||
0969|066|P|   This medication contains sodium. Consult your doctor or||
0969|067|P|pharmacist if you are on a salt-restricted diet or if you have a||
0969|068|P|condition that could be worsened by an increase in salt intake||
0969|069|P|(such as heart failure, high blood pressure).||
0969|070|P|   Before having surgery, tell your doctor or dentist about all||
0969|071|P|the products you use (including prescription drugs,||
0969|072|P|nonprescription drugs, and herbal products).||
0969|073|P|   This medication is made from human blood. Even though the||
0969|074|P|blood is carefully tested and this medication goes through a||
0969|075|P|special manufacturing process, there is an extremely small chance||
0969|076|P|that you may get infections from the medication (including virus||
0969|077|P|infections such as hepatitis). Consult your doctor or pharmacist||
0969|078|P|for more information, and ask whether you should get vaccinations||
0969|079|P|before receiving this medication.||
0969|080|P|   During pregnancy, this medication should be used only when||
0969|081|P|clearly needed. Discuss the risks and benefits with your doctor.||
0969|082|P|   It is unknown if this drug passes into breast milk. Consult||
0969|083|P|your doctor before breastfeeding.||
0969|084|B|||
0969|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0969|086|I|medications work or increase your risk for serious side effects.||
0969|087|I|This document does not contain all possible drug interactions.||
0969|088|I|Keep a list of all the products you use (including||
0969|089|I|prescription/nonprescription drugs and herbal products) and share||
0969|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
0969|091|I|the dosage of any medicines without your doctor's approval.||
0969|092|I|   Some products that may interact with this drug include:||
0969|093|I|anti-platelet medications (including clopidogrel, NSAIDs such as||
0969|094|I|aspirin/ibuprofen), "blood thinners" (such as enoxaparin,||
0969|095|I|heparin, warfarin), clot-dissolving drugs (including||
0969|096|I|thrombolytics such as alteplase).||
0969|097|I|   If your doctor has prescribed low doses of aspirin to prevent||
0969|098|I|heart attack or stroke (usually 81-162 milligrams a day), you||
0969|099|I|should continue to take the aspirin. Consult your doctor or||
0969|100|I|pharmacist for more details.||
0969|101|B|||
0969|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0969|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0969|104|O|poison control center right away. US residents can call||
0969|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0969|106|B|||
0969|107|N|NOTES:  Lab and/or medical tests (such as protein C||
0969|108|N|activity/levels) should be done while you are using this||
0969|109|N|medication. Keep all medical and lab appointments. Consult your||
0969|110|N|doctor for more details.||
0969|111|B|||
0969|112|D|MISSED DOSE:  It is important to get each dose of this medication||
0969|113|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0969|114|D|right away for a new dosing schedule.||
0969|115|B|||
0969|116|R|STORAGE:  Not applicable. This medication is given in a clinic||
0969|117|R|and will not be stored at home.||
0969|118|B|||
0969|119|A|Information last revised April 2025.||
0969|120|A|Copyright(c) 2025 First Databank, Inc.||
0969|121|B|||
0970|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0970|002|Z|does NOT have all possible information about this product. This||
0970|003|Z|information does not assure that this product is safe, effective,||
0970|004|Z|or appropriate for you. This information is not individual||
0970|005|Z|medical advice and does not substitute for the advice of your||
0970|006|Z|health care professional. Always ask your health care||
0970|007|Z|professional for complete information about this product and your||
0970|008|Z|specific health needs.||
0970|009|B|||
0970|010|T|BUSERELIN - INJECTION||
0970|011|F|(BUE-se-REL-in)||
0970|012|B|||
0970|013|U|USES:  Buserelin is used to treat advanced prostate cancer. It is||
0970|014|U|not a cure. Most types of prostate cancer need the hormone||
0970|015|U|testosterone to grow and spread. This medication works by||
0970|016|U|reducing the amount of testosterone that the body makes. This||
0970|017|U|effect helps slow or stop the growth of cancer cells and helps||
0970|018|U|relieve symptoms such as painful/difficult urination. Talk to||
0970|019|U|your doctor about the risks and benefits of treatment.||
0970|020|U|   Buserelin is a man-made hormone that is similar to a natural||
0970|021|U|hormone made by the body (gonadotropin-releasing hormone-GnRH).||
0970|022|B|||
0970|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0970|024|H|from your pharmacist before you start using this drug and each||
0970|025|H|time you get a refill. Ask your health care professional how to||
0970|026|H|prepare and use this medication. If you have any questions, ask||
0970|027|H|your doctor or pharmacist.||
0970|028|H|   Inject this medication under the skin as directed by your||
0970|029|H|doctor, usually every 8 hours for the first week of treatment,||
0970|030|H|and then once a day thereafter.||
0970|031|H|   Before using, check this product for particles or||
0970|032|H|discoloration. If either is present, do not use the liquid.||
0970|033|H|Before injecting each dose, clean the skin you are going to||
0970|034|H|inject into (the injection site) with rubbing alcohol. Change the||
0970|035|H|injection site each time to lessen injury under the skin. To||
0970|036|H|lessen bruising, do not rub the injection site after a shot.||
0970|037|H|Learn how to store and discard medical supplies safely.||
0970|038|H|   Buserelin works best when the amount of medicine in your body||
0970|039|H|is kept at a constant level. Use this drug regularly at evenly||
0970|040|H|spaced intervals. To help you remember, use it at the same||
0970|041|H|time(s) each day.||
0970|042|H|   Tell your doctor if your condition does not get better or if||
0970|043|H|it gets worse.||
0970|044|B|||
0970|045|S|SIDE EFFECTS:  Hot flashes (flushing), decreased sexual||
0970|046|S|interest/ability, swelling ankles/feet, upset stomach, joint||
0970|047|S|pain, dizziness, mood swings, breast pain/swelling, or||
0970|048|S|pain/redness/swelling at the injection site may occur. If any of||
0970|049|S|these effects last or get worse, tell your doctor or pharmacist||
0970|050|S|promptly.||
0970|051|S|   Remember that this medication has been prescribed because your||
0970|052|S|doctor has judged that the benefit to you is greater than the||
0970|053|S|risk of side effects. Many people using this medication do not||
0970|054|S|have serious side effects.||
0970|055|S|   During the first few weeks of treatment, your hormone levels||
0970|056|S|will actually increase before they decrease. This is your body's||
0970|057|S|normal response to this drug. Your symptoms may get worse for a||
0970|058|S|few weeks when you first start treatment. If your symptoms do not||
0970|059|S|improve after this time, consult your doctor promptly.||
0970|060|S|   If you have prostate cancer that has spread to the spine or||
0970|061|S|caused urinary blockage, your doctor may need to monitor your||
0970|062|S|condition more closely, especially during the first few weeks of||
0970|063|S|treatment. Tell your doctor right away if any of the following||
0970|064|S|serious symptoms occur or worsen: bone pain,||
0970|065|S|numbness/tingling/weakness of the arms/legs, blood in the urine,||
0970|066|S|painful/difficult urination, unusual weakness, inability to move.||
0970|067|S|   Tell your doctor right away if you have any serious side||
0970|068|S|effects, including: mental/mood changes (such as depression),||
0970|069|S|new/worsening bone pain, broken bones, signs of liver disease||
0970|070|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
0970|071|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0970|072|S|   This medication may rarely make your blood sugar rise, which||
0970|073|S|can cause or worsen diabetes. Tell your doctor right away if you||
0970|074|S|have symptoms of high blood sugar such as increased||
0970|075|S|thirst/urination. If you already have diabetes, check your blood||
0970|076|S|sugar regularly as directed and share the results with your||
0970|077|S|doctor. Your doctor may need to adjust your diabetes medication,||
0970|078|S|exercise program, or diet.||
0970|079|S|   Get medical help right away if you have any very serious side||
0970|080|S|effects, including: chest/jaw/left arm pain, trouble breathing,||
0970|081|S|weakness on one side of the body, trouble speaking,||
0970|082|S|fast/irregular heartbeat, severe dizziness, fainting.||
0970|083|S|   A very serious allergic reaction to this drug is rare.||
0970|084|S|However, get medical help right away if you notice any symptoms||
0970|085|S|of a serious allergic reaction, including: fever, swollen lymph||
0970|086|S|nodes, rash, itching/swelling (especially of the||
0970|087|S|face/tongue/throat), severe dizziness, trouble breathing.||
0970|088|S|   This is not a complete list of possible side effects. If you||
0970|089|S|notice other effects not listed above, contact your doctor or||
0970|090|S|pharmacist.||
0970|091|S|   In the US -||
0970|092|S|   Call your doctor for medical advice about side effects. You||
0970|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0970|094|S|www.fda.gov/medwatch.||
0970|095|S|   In Canada - Call your doctor for medical advice about side||
0970|096|S|effects. You may report side effects to Health Canada at||
0970|097|S|1-866-234-2345.||
0970|098|B|||
0970|099|P|PRECAUTIONS:  Before using buserelin, tell your doctor or||
0970|100|P|pharmacist if you are allergic to it; or if you have any other||
0970|101|P|allergies. This product may contain inactive ingredients, which||
0970|102|P|can cause allergic reactions or other problems. Talk to your||
0970|103|P|pharmacist for more details.||
0970|104|P|   Before using this medication, tell your doctor or pharmacist||
0970|105|P|your medical history, especially of: heart disease (such as heart||
0970|106|P|attack), stroke, high cholesterol, high blood pressure, diabetes,||
0970|107|P|mental/mood problems (such as depression).||
0970|108|P|   If buserelin is used for a long time, it may weaken your bones||
0970|109|P|and increase your risk for bone loss (osteoporosis). Before using||
0970|110|P|this medication, tell your doctor or pharmacist if you have||
0970|111|P|osteoporosis or if you have any of the following risk factors:||
0970|112|P|long-term alcohol use, smoking, family history of osteoporosis||
0970|113|P|and broken bones, use of certain medications (including||
0970|114|P|corticosteroids such as prednisone, certain anti-seizure drugs||
0970|115|P|such as phenytoin).||
0970|116|P|   Buserelin may cause a condition that affects the heart rhythm||
0970|117|P|(QT prolongation). QT prolongation can rarely cause serious||
0970|118|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0970|119|P|as severe dizziness, fainting) that need medical attention right||
0970|120|P|away.||
0970|121|P|   The risk of QT prolongation may be increased if you have||
0970|122|P|certain medical conditions or are taking other drugs that may||
0970|123|P|cause QT prolongation. Before using buserelin, tell your doctor||
0970|124|P|or pharmacist of all the drugs you take and if you have any of||
0970|125|P|the following conditions: certain heart problems (heart failure,||
0970|126|P|slow heartbeat, QT prolongation in the EKG), family history of||
0970|127|P|certain heart problems (QT prolongation in the EKG, sudden||
0970|128|P|cardiac death).||
0970|129|P|   Low levels of potassium or magnesium in the blood may also||
0970|130|P|increase your risk of QT prolongation. This risk may increase if||
0970|131|P|you use certain drugs (such as diuretics/"water pills") or if you||
0970|132|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0970|133|P|Talk to your doctor about using buserelin safely.||
0970|134|P|   If you have diabetes, this drug may make it harder to control||
0970|135|P|your blood sugar. Check your blood sugar regularly as directed||
0970|136|P|and share the results with your doctor. Tell your doctor right||
0970|137|P|away if you have symptoms of high blood sugar (see Side Effects||
0970|138|P|section). Your doctor may need to adjust your diabetes||
0970|139|P|medication, exercise program, or diet.||
0970|140|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0970|141|P|can make you more dizzy. Do not drive, use machinery, or do||
0970|142|P|anything that needs alertness until you can do it safely. Limit||
0970|143|P|alcoholic beverages. Talk to your doctor if you are using||
0970|144|P|marijuana (cannabis).||
0970|145|P|   Older adults may be more sensitive to the side effects of this||
0970|146|P|drug, especially QT prolongation (see above).||
0970|147|P|   Use of this medication for a long time may make the testicles||
0970|148|P|unable to produce testosterone or sperm. It is not known if these||
0970|149|P|effects go away in all men after the medication is stopped.||
0970|150|P|However, these effects alone should not be considered a reliable||
0970|151|P|form of birth control. Men using this medication should use||
0970|152|P|reliable birth control methods (such as condoms) to prevent||
0970|153|P|pregnancy. Ask your doctor for more details and to discuss||
0970|154|P|reliable forms of birth control.||
0970|155|P|   Buserelin has been used in women for other conditions. This||
0970|156|P|medication must not be used during pregnancy. It may harm an||
0970|157|P|unborn baby. Women should consult their doctor for more details||
0970|158|P|and to discuss reliable forms of non-hormonal birth control.||
0970|159|P|   When buserelin is used in women for other conditions, small||
0970|160|P|amounts of this medication pass into breast milk. Because of the||
0970|161|P|possible risk to the infant, breastfeeding is not recommended||
0970|162|P|while using this medication. Women should consult their doctor||
0970|163|P|before breastfeeding.||
0970|164|B|||
0970|165|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0970|166|I|medications work or increase your risk for serious side effects.||
0970|167|I|This document does not contain all possible drug interactions.||
0970|168|I|Keep a list of all the products you use (including||
0970|169|I|prescription/nonprescription drugs and herbal products) and share||
0970|170|I|it with your doctor and pharmacist. Do not start, stop, or change||
0970|171|I|the dosage of any medicines without your doctor's approval.||
0970|172|B|||
0970|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0970|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0970|175|O|poison control center right away. US residents can call||
0970|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0970|177|B|||
0970|178|N|NOTES:  Do not share this medication with others.||
0970|179|N|   Lab and/or medical tests (such as hormone levels, PSA blood||
0970|180|N|test, blood sugar, cholesterol/triglyceride levels, bone tests)||
0970|181|N|should be done while you are using this medication. Keep all||
0970|182|N|medical and lab appointments. Consult your doctor for more||
0970|183|N|details.||
0970|184|B|||
0970|185|D|MISSED DOSE:  It is important to get each dose of this medication||
0970|186|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0970|187|D|right away for a new dosing schedule. Do not double the dose to||
0970|188|D|catch up.||
0970|189|B|||
0970|190|R|STORAGE:  Store at room temperature. Keep the medication in the||
0970|191|R|original packaging to protect from light. This medication should||
0970|192|R|be discarded 14 days after opening. Keep all medications away||
0970|193|R|from children and pets.||
0970|194|R|   Do not flush medications down the toilet or pour them into a||
0970|195|R|drain unless instructed to do so. Properly discard this product||
0970|196|R|when it is expired or no longer needed. Consult your pharmacist||
0970|197|R|or local waste disposal company.||
0970|198|B|||
0970|199|A|Information last revised September 2025.||
0970|200|A|Copyright(c) 2025 First Databank, Inc.||
0970|201|B|||
0971|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0971|002|Z|does NOT have all possible information about this product. This||
0971|003|Z|information does not assure that this product is safe, effective,||
0971|004|Z|or appropriate for you. This information is not individual||
0971|005|Z|medical advice and does not substitute for the advice of your||
0971|006|Z|health care professional. Always ask your health care||
0971|007|Z|professional for complete information about this product and your||
0971|008|Z|specific health needs.||
0971|009|B|||
0971|010|T|TERBINAFINE GEL - TOPICAL||
0971|011|F|(ter-BIN-uh-feen)||
0971|012|B|||
0971|013|C|COMMON BRAND NAME(S): Lamisil AT||
0971|014|B|||
0971|015|U|USES:  This medication is used to treat a variety of fungal skin||
0971|016|U|infections such as ringworm, athlete's foot, and jock itch. It||
0971|017|U|also helps to relieve the itching, burning, cracking, and scaling||
0971|018|U|from these infections. Terbinafine is an antifungal that works by||
0971|019|U|preventing the growth of fungus.||
0971|020|B|||
0971|021|H|HOW TO USE:  Use this medication on the skin only. Clean and||
0971|022|H|thoroughly dry the area to be treated. Apply a thin layer of the||
0971|023|H|medication on and around the affected area, usually once daily as||
0971|024|H|directed on the product package. If you have any questions, ask||
0971|025|H|your doctor or pharmacist. Wash your hands after using unless the||
0971|026|H|area being treated includes the hands. Do not wrap, cover, or||
0971|027|H|bandage the area unless directed to do so by your doctor.||
0971|028|H|   Do not apply the medication in the eyes, nose, or mouth, or||
0971|029|H|inside the vagina. If you do get the medication in those areas,||
0971|030|H|flush with plenty of water.||
0971|031|H|   Do not apply this medication on the scalp or nails unless||
0971|032|H|directed by your doctor.||
0971|033|H|   Do not apply more often or use longer than directed. Doing so||
0971|034|H|may increase the risk of side effects.||
0971|035|H|   Use this medication regularly to get the most benefit from it.||
0971|036|H|To help you remember, use it at the same time each day.||
0971|037|H|   Continue to use this medication until the full treatment||
0971|038|H|period is finished, even if symptoms disappear after a few days.||
0971|039|H|Stopping the medication too early may result in a return of the||
0971|040|H|infection.||
0971|041|H|   Your condition may continue to improve after the full||
0971|042|H|treatment is finished. It may take several weeks after treatment||
0971|043|H|for the infection to completely heal. Tell your doctor if your||
0971|044|H|condition gets worse or if it does not get better within 2 weeks.||
0971|045|B|||
0971|046|S|SIDE EFFECTS:  Burning, irritation, or itching at the application||
0971|047|S|site may occur. If any of these effects last or get worse, tell||
0971|048|S|your doctor or pharmacist promptly.||
0971|049|S|   If your doctor has directed you to use this medication,||
0971|050|S|remember that your doctor has judged that the benefit to you is||
0971|051|S|greater than the risk of side effects. Many people using this||
0971|052|S|medication do not have serious side effects.||
0971|053|S|   Tell your doctor right away if you have any serious side||
0971|054|S|effects, including: blistering/swelling/oozing at the application||
0971|055|S|site.||
0971|056|S|   A very serious allergic reaction to this drug is rare.||
0971|057|S|However, get medical help right away if you notice any symptoms||
0971|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0971|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0971|060|S|breathing.||
0971|061|S|   This is not a complete list of possible side effects. If you||
0971|062|S|notice other effects not listed above, contact your doctor or||
0971|063|S|pharmacist.||
0971|064|S|   In the US -||
0971|065|S|   Call your doctor for medical advice about side effects. You||
0971|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0971|067|S|www.fda.gov/medwatch.||
0971|068|S|   In Canada - Call your doctor for medical advice about side||
0971|069|S|effects. You may report side effects to Health Canada at||
0971|070|S|1-866-234-2345.||
0971|071|B|||
0971|072|P|PRECAUTIONS:  Before using terbinafine, tell your doctor or||
0971|073|P|pharmacist if you are allergic to it; or to other allylamine||
0971|074|P|antifungals (such as naftifine); or if you have any other||
0971|075|P|allergies. This product may contain inactive ingredients, which||
0971|076|P|can cause allergic reactions or other problems. Talk to your||
0971|077|P|pharmacist for more details.||
0971|078|P|   If you have the following health problem, consult your doctor||
0971|079|P|or pharmacist before using this product: athlete's foot on the||
0971|080|P|bottom or side of the foot.||
0971|081|P|   During pregnancy, this medication should be used only when||
0971|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
0971|083|P|   It is unknown if this drug passes into breast milk when||
0971|084|P|applied to the skin. Other forms of this medication pass into||
0971|085|P|breast milk when taken by mouth. Consult your doctor before||
0971|086|P|breastfeeding.||
0971|087|B|||
0971|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0971|089|I|medications work or increase your risk for serious side effects.||
0971|090|I|This document does not contain all possible drug interactions.||
0971|091|I|Keep a list of all the products you use (including||
0971|092|I|prescription/nonprescription drugs and herbal products) and share||
0971|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
0971|094|I|the dosage of any medicines without your doctor's approval.||
0971|095|B|||
0971|096|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0971|097|O|has overdosed and has serious symptoms such as passing out or||
0971|098|O|trouble breathing, call 911. Otherwise, call a poison control||
0971|099|O|center right away. US residents can call 1-800-222-1222. Canada||
0971|100|O|residents can call 1-844-764-7669.||
0971|101|B|||
0971|102|N|NOTES:  Keep all medical and lab appointments.||
0971|103|N|   If you are treating athlete's foot, make sure to wear||
0971|104|N|well-fitting, ventilated shoes. Also, change shoes and socks at||
0971|105|N|least once daily.||
0971|106|B|||
0971|107|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0971|108|D|If it is near the time of the next dose, skip the missed dose.||
0971|109|D|Use your next dose at the regular time. Do not double the dose to||
0971|110|D|catch up.||
0971|111|B|||
0971|112|R|STORAGE:  Store at room temperature away from heat. Keep all||
0971|113|R|medications away from children and pets.||
0971|114|R|   Do not flush medications down the toilet or pour them into a||
0971|115|R|drain unless instructed to do so. Properly discard this product||
0971|116|R|when it is expired or no longer needed. Consult your pharmacist||
0971|117|R|or local waste disposal company.||
0971|118|B|||
0971|119|A|Information last revised November 2024.||
0971|120|A|Copyright(c) 2025 First Databank, Inc.||
0971|121|B|||
0972|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0972|002|Z|does NOT have all possible information about this product. This||
0972|003|Z|information does not assure that this product is safe, effective,||
0972|004|Z|or appropriate for you. This information is not individual||
0972|005|Z|medical advice and does not substitute for the advice of your||
0972|006|Z|health care professional. Always ask your health care||
0972|007|Z|professional for complete information about this product and your||
0972|008|Z|specific health needs.||
0972|009|B|||
0972|010|T|BUSERELIN - IMPLANT||
0972|011|F|(BUE-se-REL-in)||
0972|012|B|||
0972|013|U|USES:  Buserelin is used to treat advanced prostate cancer. It is||
0972|014|U|not a cure. Most types of prostate cancer need the hormone||
0972|015|U|testosterone to grow and spread. This medication works by||
0972|016|U|reducing the amount of testosterone that the body makes. This||
0972|017|U|effect helps slow or stop the growth of cancer cells and helps||
0972|018|U|relieve symptoms such as painful/difficult urination. Talk to||
0972|019|U|your doctor about the risks and benefits of treatment.||
0972|020|U|   Buserelin is a man-made hormone that is similar to a natural||
0972|021|U|hormone made by the body (gonadotropin-releasing hormone-GnRH).||
0972|022|B|||
0972|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0972|024|H|from your pharmacist before you start using buserelin and each||
0972|025|H|time you get a refill. If you have any questions, ask your doctor||
0972|026|H|or pharmacist.||
0972|027|H|   Your doctor will inject the medicated rods (implants) under||
0972|028|H|the skin of your abdomen. The implants release buserelin into||
0972|029|H|your blood slowly and continuously over several months. Buserelin||
0972|030|H|works best when the amount of medicine in your body is kept at a||
0972|031|H|constant level. Keep regularly scheduled appointments with your||
0972|032|H|doctor to have the implants replaced every few months.||
0972|033|H|   Tell your doctor if your condition does not get better or if||
0972|034|H|it gets worse.||
0972|035|B|||
0972|036|S|SIDE EFFECTS:  Hot flashes (flushing), decreased sexual||
0972|037|S|interest/ability, change in the amount of scalp/body hair, upset||
0972|038|S|stomach, joint pain, dizziness, mood swings, breast||
0972|039|S|pain/swelling, or pain/redness/swelling at the injection site may||
0972|040|S|occur. If any of these effects last or get worse, tell your||
0972|041|S|doctor or pharmacist promptly.||
0972|042|S|   Remember that this medication has been prescribed because your||
0972|043|S|doctor has judged that the benefit to you is greater than the||
0972|044|S|risk of side effects. Many people using this medication do not||
0972|045|S|have serious side effects.||
0972|046|S|   During the first few weeks of treatment, your hormone levels||
0972|047|S|will actually increase before they decrease. This is your body's||
0972|048|S|normal response to this drug. Your symptoms may get worse for a||
0972|049|S|few weeks when you first start treatment. If your symptoms do not||
0972|050|S|improve after this time, consult your doctor promptly.||
0972|051|S|   If you have prostate cancer that has spread to the spine or||
0972|052|S|caused urinary blockage, your doctor may need to monitor your||
0972|053|S|condition more closely, especially during the first few weeks of||
0972|054|S|treatment. Tell your doctor right away if any of the following||
0972|055|S|serious symptoms occur or worsen: bone pain,||
0972|056|S|numbness/tingling/weakness of the arms/legs, blood in the urine,||
0972|057|S|painful/difficult urination, unusual weakness, inability to move.||
0972|058|S|   Tell your doctor right away if you have any serious side||
0972|059|S|effects, including: mental/mood changes (such as depression),||
0972|060|S|new/worsening bone pain, broken bones, signs of liver disease||
0972|061|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
0972|062|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
0972|063|S|   This medication may rarely make your blood sugar rise, which||
0972|064|S|can cause or worsen diabetes. Tell your doctor right away if you||
0972|065|S|have symptoms of high blood sugar such as increased||
0972|066|S|thirst/urination. If you already have diabetes, check your blood||
0972|067|S|sugar regularly as directed and share the results with your||
0972|068|S|doctor. Your doctor may need to adjust your diabetes medication,||
0972|069|S|exercise program, or diet.||
0972|070|S|   Get medical help right away if you have any very serious side||
0972|071|S|effects, including: chest/jaw/left arm pain, trouble breathing,||
0972|072|S|weakness on one side of the body, trouble speaking,||
0972|073|S|fast/irregular heartbeat, severe dizziness, fainting.||
0972|074|S|   A very serious allergic reaction to this drug is rare.||
0972|075|S|However, get medical help right away if you notice any symptoms||
0972|076|S|of a serious allergic reaction, including: fever, swollen lymph||
0972|077|S|nodes, rash, itching/swelling (especially of the||
0972|078|S|face/tongue/throat), severe dizziness, trouble breathing.||
0972|079|S|   This is not a complete list of possible side effects. If you||
0972|080|S|notice other effects not listed above, contact your doctor or||
0972|081|S|pharmacist.||
0972|082|S|   In the US -||
0972|083|S|   Call your doctor for medical advice about side effects. You||
0972|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0972|085|S|www.fda.gov/medwatch.||
0972|086|S|   In Canada - Call your doctor for medical advice about side||
0972|087|S|effects. You may report side effects to Health Canada at||
0972|088|S|1-866-234-2345.||
0972|089|B|||
0972|090|P|PRECAUTIONS:  Before using buserelin, tell your doctor or||
0972|091|P|pharmacist if you are allergic to it; or if you have any other||
0972|092|P|allergies. This product may contain inactive ingredients, which||
0972|093|P|can cause allergic reactions or other problems. Talk to your||
0972|094|P|pharmacist for more details.||
0972|095|P|   Before using this medication, tell your doctor or pharmacist||
0972|096|P|your medical history, especially of: heart disease (such as heart||
0972|097|P|attack), stroke, high cholesterol, high blood pressure, diabetes,||
0972|098|P|mental/mood problems (such as depression).||
0972|099|P|   If buserelin is used for a long time, it may weaken your bones||
0972|100|P|and increase your risk for bone loss (osteoporosis). Before using||
0972|101|P|this medication, tell your doctor or pharmacist if you have||
0972|102|P|osteoporosis or if you have any of the following risk factors:||
0972|103|P|long-term alcohol use, smoking, family history of osteoporosis||
0972|104|P|and broken bones, use of certain medications (including||
0972|105|P|corticosteroids such as prednisone, certain anti-seizure drugs||
0972|106|P|such as phenytoin).||
0972|107|P|   Buserelin may cause a condition that affects the heart rhythm||
0972|108|P|(QT prolongation). QT prolongation can rarely cause serious||
0972|109|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0972|110|P|as severe dizziness, fainting) that need medical attention right||
0972|111|P|away.||
0972|112|P|   The risk of QT prolongation may be increased if you have||
0972|113|P|certain medical conditions or are taking other drugs that may||
0972|114|P|cause QT prolongation. Before using buserelin, tell your doctor||
0972|115|P|or pharmacist of all the drugs you take and if you have any of||
0972|116|P|the following conditions: certain heart problems (heart failure,||
0972|117|P|slow heartbeat, QT prolongation in the EKG), family history of||
0972|118|P|certain heart problems (QT prolongation in the EKG, sudden||
0972|119|P|cardiac death).||
0972|120|P|   Low levels of potassium or magnesium in the blood may also||
0972|121|P|increase your risk of QT prolongation. This risk may increase if||
0972|122|P|you use certain drugs (such as diuretics/"water pills") or if you||
0972|123|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0972|124|P|Talk to your doctor about using buserelin safely.||
0972|125|P|   If you have diabetes, this drug may make it harder to control||
0972|126|P|your blood sugar. Check your blood sugar regularly as directed||
0972|127|P|and share the results with your doctor. Tell your doctor right||
0972|128|P|away if you have symptoms of high blood sugar (see Side Effects||
0972|129|P|section). Your doctor may need to adjust your diabetes||
0972|130|P|medication, exercise program, or diet.||
0972|131|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0972|132|P|can make you more dizzy. Do not drive, use machinery, or do||
0972|133|P|anything that needs alertness until you can do it safely. Limit||
0972|134|P|alcoholic beverages. Talk to your doctor if you are using||
0972|135|P|marijuana (cannabis).||
0972|136|P|   Older adults may be more sensitive to the side effects of this||
0972|137|P|drug, especially QT prolongation (see above).||
0972|138|P|   Use of this medication for a long time may make the testicles||
0972|139|P|unable to produce testosterone or sperm. It is not known if these||
0972|140|P|effects go away in all men after the medication is stopped.||
0972|141|P|However, these effects alone should not be considered a reliable||
0972|142|P|form of birth control. Men using this medication should use||
0972|143|P|reliable birth control methods (such as condoms) to prevent||
0972|144|P|pregnancy. Ask your doctor for more details and to discuss||
0972|145|P|reliable forms of birth control.||
0972|146|P|   This product is not approved for use in women or children.||
0972|147|P|Buserelin must not be used during pregnancy. It may harm an||
0972|148|P|unborn baby. Consult your doctor for details.||
0972|149|B|||
0972|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0972|151|I|medications work or increase your risk for serious side effects.||
0972|152|I|This document does not contain all possible drug interactions.||
0972|153|I|Keep a list of all the products you use (including||
0972|154|I|prescription/nonprescription drugs and herbal products) and share||
0972|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
0972|156|I|the dosage of any medicines without your doctor's approval.||
0972|157|B|||
0972|158|O|OVERDOSE:  This implant may be harmful if swallowed. If someone||
0972|159|O|has swallowed it and has serious symptoms such as passing out or||
0972|160|O|trouble breathing, call 911. Otherwise, call a poison control||
0972|161|O|center right away. US residents can call 1-800-222-1222. Canada||
0972|162|O|residents can call 1-844-764-7669.||
0972|163|B|||
0972|164|N|NOTES:  Lab and/or medical tests (such as hormone levels, PSA||
0972|165|N|blood test, blood sugar, cholesterol/triglyceride levels, bone||
0972|166|N|tests) should be done while you are using this medication. Keep||
0972|167|N|all medical and lab appointments. Consult your doctor for more||
0972|168|N|details.||
0972|169|N|   If you have radiology tests (such as X-rays, MRI), make sure||
0972|170|N|radiology personnel and all your doctors know you use this||
0972|171|N|product.||
0972|172|B|||
0972|173|D|MISSED DOSE:  To help prevent a missed dose, mark your calendar||
0972|174|D|with your next scheduled implant appointment. Keep all medical||
0972|175|D|and lab appointments.||
0972|176|B|||
0972|177|R|STORAGE:  Before this product is placed in the body, store it at||
0972|178|R|room temperature away from heat. Keep all medications away from||
0972|179|R|children and pets.||
0972|180|R|   Do not flush medications down the toilet or pour them into a||
0972|181|R|drain unless instructed to do so. Properly discard this product||
0972|182|R|when it is expired or no longer needed. Consult your pharmacist||
0972|183|R|or local waste disposal company.||
0972|184|B|||
0972|185|A|Information last revised September 2025.||
0972|186|A|Copyright(c) 2025 First Databank, Inc.||
0972|187|B|||
0973|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0973|002|Z|does NOT have all possible information about this product. This||
0973|003|Z|information does not assure that this product is safe, effective,||
0973|004|Z|or appropriate for you. This information is not individual||
0973|005|Z|medical advice and does not substitute for the advice of your||
0973|006|Z|health care professional. Always ask your health care||
0973|007|Z|professional for complete information about this product and your||
0973|008|Z|specific health needs.||
0973|009|B|||
0973|010|T|AMLODIPINE/VALSARTAN - ORAL||
0973|011|F|(am-LOE-di-peen/val-SAR-tan)||
0973|012|B|||
0973|013|C|COMMON BRAND NAME(S): Exforge||
0973|014|B|||
0973|015|W|WARNING:  Valsartan can cause serious (possibly fatal) harm to an||
0973|016|W|unborn baby if used during pregnancy. It is important to prevent||
0973|017|W|pregnancy while taking this medication. Consult your doctor for||
0973|018|W|more details and to discuss the use of reliable forms of birth||
0973|019|W|control while taking this medication. If you are planning||
0973|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
0973|021|W|your doctor right away.||
0973|022|B|||
0973|023|U|USES:  This product is used to treat high blood pressure.||
0973|024|U|Lowering high blood pressure helps prevent strokes, heart||
0973|025|U|attacks, and kidney problems.||
0973|026|U|   This product contains 2 medications: amlodipine and valsartan.||
0973|027|U|They both work by relaxing blood vessels so blood can flow more||
0973|028|U|easily. Amlodipine is a calcium channel blocker and valsartan is||
0973|029|U|an angiotensin receptor blocker (ARB).||
0973|030|B|||
0973|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0973|032|H|from your pharmacist before you start taking this product and||
0973|033|H|each time you get a refill. If you have any questions, ask your||
0973|034|H|doctor or pharmacist.||
0973|035|H|   Take this medication by mouth with or without food as directed||
0973|036|H|by your doctor, usually once daily.||
0973|037|H|   The dosage is based on your medical condition and response to||
0973|038|H|treatment.||
0973|039|H|   Take this medication regularly to get the most benefit from||
0973|040|H|it. To help you remember, take it at the same time each day. It||
0973|041|H|may take several weeks before you get the full benefit of this||
0973|042|H|product. Keep taking this product even if you feel well. Most||
0973|043|H|people with high blood pressure do not feel sick.||
0973|044|H|   Tell your doctor if your condition does not get better or if||
0973|045|H|it gets worse (your blood pressure readings remain high or||
0973|046|H|increase).||
0973|047|B|||
0973|048|S|SIDE EFFECTS:  Dizziness, lightheadedness, or tiredness may occur||
0973|049|S|as your body adjusts to the medication. Dry cough or||
0973|050|S|abdominal/stomach pain may also occur. If any of these effects||
0973|051|S|last or get worse, tell your doctor or pharmacist promptly.||
0973|052|S|   To reduce the risk of dizziness and lightheadedness, get up||
0973|053|S|slowly when rising from a sitting or lying position.||
0973|054|S|   Remember that this medication has been prescribed because your||
0973|055|S|doctor has judged that the benefit to you is greater than the||
0973|056|S|risk of side effects. Many people using this medication do not||
0973|057|S|have serious side effects.||
0973|058|S|   Tell your doctor right away if you have any serious side||
0973|059|S|effects, including: swelling hands/ankles/feet, fainting, fast||
0973|060|S|heartbeat, signs of kidney problems (such as change in the amount||
0973|061|S|of urine), symptoms of a high potassium blood level (such as||
0973|062|S|muscle weakness, slow/irregular heartbeat), signs of infection||
0973|063|S|(such as sore throat that doesn't go away, fever, chills).||
0973|064|S|   Some people who already have severe heart disease may rarely||
0973|065|S|develop worsening chest pain or a heart attack after starting||
0973|066|S|this medication or increasing the dose. Get medical help right||
0973|067|S|away if you experience: worsening chest pain, symptoms of a heart||
0973|068|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
0973|069|S|unusual sweating).||
0973|070|S|   A very serious allergic reaction to this drug is rare.||
0973|071|S|However, get medical help right away if you notice any symptoms||
0973|072|S|of a serious allergic reaction, including: rash, itching/swelling||
0973|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0973|074|S|breathing.||
0973|075|S|   This is not a complete list of possible side effects. If you||
0973|076|S|notice other effects not listed above, contact your doctor or||
0973|077|S|pharmacist.||
0973|078|S|   In the US -||
0973|079|S|   Call your doctor for medical advice about side effects. You||
0973|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0973|081|S|www.fda.gov/medwatch.||
0973|082|S|   In Canada - Call your doctor for medical advice about side||
0973|083|S|effects. You may report side effects to Health Canada at||
0973|084|S|1-866-234-2345.||
0973|085|B|||
0973|086|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
0973|087|P|pharmacist if you are allergic to either amlodipine or valsartan,||
0973|088|P|or if you have any other allergies. This product may contain||
0973|089|P|inactive ingredients, which can cause allergic reactions or other||
0973|090|P|problems. Talk to your pharmacist for more details.||
0973|091|P|   Before using this medication, tell your doctor or pharmacist||
0973|092|P|your medical history, especially of: liver disease, a certain||
0973|093|P|heart valve condition (aortic stenosis), dehydration, high level||
0973|094|P|of potassium in the blood.||
0973|095|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0973|096|P|can make you more dizzy. Do not drive, use machinery, or do||
0973|097|P|anything that needs alertness until you can do it safely. Limit||
0973|098|P|alcoholic beverages. Talk to your doctor if you are using||
0973|099|P|marijuana (cannabis).||
0973|100|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
0973|101|P|and cause you to feel lightheaded. Tell your doctor if you have||
0973|102|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
0973|103|P|of fluids unless your doctor tells you not to.||
0973|104|P|   This product may increase your potassium levels. Before using||
0973|105|P|potassium supplements or salt substitutes that contain potassium,||
0973|106|P|consult your doctor or pharmacist.||
0973|107|P|   Before having surgery, tell your doctor or dentist about all||
0973|108|P|the products you use (including prescription drugs,||
0973|109|P|nonprescription drugs, and herbal products).||
0973|110|P|   Older adults may be more sensitive to the side effects of this||
0973|111|P|drug, especially dizziness and change in the amount of urine||
0973|112|P|(kidney problems).||
0973|113|P|   Tell your doctor if you are pregnant or plan to become||
0973|114|P|pregnant. You should not become pregnant while using this||
0973|115|P|medication. Valsartan may harm an unborn baby. If you become||
0973|116|P|pregnant, talk to your doctor right away about the risks and||
0973|117|P|benefits of this medication. See also Warning section.||
0973|118|P|   It is unknown if valsartan passes into breast milk. Amlodipine||
0973|119|P|passes into breast milk. Consult your doctor before||
0973|120|P|breastfeeding.||
0973|121|B|||
0973|122|I|DRUG INTERACTIONS:  See also Precautions section.||
0973|123|I|   Drug interactions may change how your medications work or||
0973|124|I|increase your risk for serious side effects. This document does||
0973|125|I|not contain all possible drug interactions. Keep a list of all||
0973|126|I|the products you use (including prescription/nonprescription||
0973|127|I|drugs and herbal products) and share it with your doctor and||
0973|128|I|pharmacist. Do not start, stop, or change the dosage of any||
0973|129|I|medicines without your doctor's approval.||
0973|130|I|   Some products that may interact with this drug include:||
0973|131|I|aliskiren, lithium, drugs that may increase the level of||
0973|132|I|potassium in the blood (such as sparsentan, ACE inhibitors||
0973|133|I|including benazepril/lisinopril, birth control pills containing||
0973|134|I|drospirenone).||
0973|135|I|   Some products have ingredients that could raise your blood||
0973|136|I|pressure. Tell your pharmacist what products you are using, and||
0973|137|I|ask how to use them safely (especially cough-and-cold products,||
0973|138|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
0973|139|B|||
0973|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0973|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0973|142|O|poison control center right away. US residents can call||
0973|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0973|144|O|Symptoms of overdose may include: severe dizziness, fainting.||
0973|145|B|||
0973|146|N|NOTES:  Do not share this medication with others.||
0973|147|N|   Lifestyle changes that may help this medication work better||
0973|148|N|include exercising, stopping smoking, and eating a||
0973|149|N|low-cholesterol/low-fat diet. Consult your doctor for more||
0973|150|N|details.||
0973|151|N|   Lab and/or medical tests (such as kidney function, potassium||
0973|152|N|levels) should be done while you are taking this product. Keep||
0973|153|N|all medical and lab appointments.||
0973|154|N|   Have your blood pressure checked regularly while taking this||
0973|155|N|medication. Learn how to monitor your own blood pressure at home,||
0973|156|N|and share the results with your doctor.||
0973|157|B|||
0973|158|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0973|159|D|remember. If it is near the time of the next dose, skip the||
0973|160|D|missed dose. Take your next dose at the regular time. Do not||
0973|161|D|double the dose to catch up.||
0973|162|B|||
0973|163|R|STORAGE:  Store at room temperature away from light and moisture.||
0973|164|R|Do not store in the bathroom. Keep all medications away from||
0973|165|R|children and pets.||
0973|166|R|   Do not flush medications down the toilet or pour them into a||
0973|167|R|drain unless instructed to do so. Properly discard this product||
0973|168|R|when it is expired or no longer needed. Consult your pharmacist||
0973|169|R|or local waste disposal company.||
0973|170|B|||
0973|171|A|Information last revised January 2025.||
0973|172|A|Copyright(c) 2025 First Databank, Inc.||
0973|173|B|||
0974|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0974|002|Z|does NOT have all possible information about this product. This||
0974|003|Z|information does not assure that this product is safe, effective,||
0974|004|Z|or appropriate for you. This information is not individual||
0974|005|Z|medical advice and does not substitute for the advice of your||
0974|006|Z|health care professional. Always ask your health care||
0974|007|Z|professional for complete information about this product and your||
0974|008|Z|specific health needs.||
0974|009|B|||
0974|010|T|ARMODAFINIL - ORAL||
0974|011|F|(AR-moe-DAF-i-nil)||
0974|012|B|||
0974|013|C|COMMON BRAND NAME(S): Nuvigil||
0974|014|B|||
0974|015|U|USES:  Armodafinil reduces extreme sleepiness due to narcolepsy||
0974|016|U|and other sleep disorders, such as periods of stopped breathing||
0974|017|U|during sleep (obstructive sleep apnea). It is also used to help||
0974|018|U|you stay awake during work hours if you have a work schedule that||
0974|019|U|keeps you from having a normal sleep routine (shift work sleep||
0974|020|U|disorder).||
0974|021|U|   This medication does not cure these sleep disorders and may||
0974|022|U|not get rid of all your sleepiness. Armodafinil does not take the||
0974|023|U|place of getting enough sleep. It should not be used to treat||
0974|024|U|tiredness or hold off sleep in people who do not have a sleep||
0974|025|U|disorder.||
0974|026|U|   It is not known how armodafinil works to keep you awake. It is||
0974|027|U|thought to work by affecting certain substances in the brain that||
0974|028|U|control the sleep/wake cycle.||
0974|029|B|||
0974|030|H|HOW TO USE:  Read the Medication Guide provided by your||
0974|031|H|pharmacist before you start using armodafinil and each time you||
0974|032|H|get a refill. If you have any questions, ask your doctor or||
0974|033|H|pharmacist.||
0974|034|H|   For narcolepsy and obstructive sleep apnea, take this||
0974|035|H|medication by mouth as directed by your doctor, usually once||
0974|036|H|daily in the morning. If you are using armodafinil for shift work||
0974|037|H|sleep disorder, take it as directed by your doctor, usually once||
0974|038|H|a day 1 hour before you start your work shift. You may take this||
0974|039|H|medication with or without food, but armodafinil may take longer||
0974|040|H|to work if you take it with food.||
0974|041|H|   If you are using this drug for sleep apnea, continue your||
0974|042|H|other treatment (such as the CPAP machine, mouth device) unless||
0974|043|H|your doctor tells you to stop.||
0974|044|H|   The dosage is based on your medical condition and response to||
0974|045|H|treatment. Take this medication regularly to get the most benefit||
0974|046|H|from it.||
0974|047|H|   Caffeine can increase the side effects of this medication.||
0974|048|H|Avoid drinking large amounts of beverages containing caffeine||
0974|049|H|(coffee, tea, colas), eating large amounts of chocolate, or||
0974|050|H|taking nonprescription products that contain caffeine.||
0974|051|H|   If you suddenly stop using this medication, you may have||
0974|052|H|withdrawal symptoms (such as shaking, sweating, chills, nausea,||
0974|053|H|vomiting, confusion). To help prevent withdrawal, your doctor may||
0974|054|H|lower your dose slowly. Withdrawal is more likely if you have||
0974|055|H|used armodafinil for a long time or in high doses. Tell your||
0974|056|H|doctor or pharmacist right away if you have withdrawal.||
0974|057|H|   When this medication is used for a long time, it may not work||
0974|058|H|as well. Talk with your doctor if this medication stops working||
0974|059|H|well.||
0974|060|H|   Though it helps many people, this medication may sometimes||
0974|061|H|cause addiction. This risk may be higher if you have a substance||
0974|062|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
0974|063|H|Take this medication exactly as prescribed to lower the risk of||
0974|064|H|addiction. Ask your doctor or pharmacist for more details.||
0974|065|H|   Tell your doctor if your condition does not get better or if||
0974|066|H|it gets worse.||
0974|067|B|||
0974|068|S|SIDE EFFECTS:  Headache, nausea, dry mouth, nervousness,||
0974|069|S|dizziness, or difficulty sleeping may occur. If any of these||
0974|070|S|effects last or get worse, tell your doctor or pharmacist||
0974|071|S|promptly.||
0974|072|S|   Remember that this medication has been prescribed because your||
0974|073|S|doctor has judged that the benefit to you is greater than the||
0974|074|S|risk of side effects. Many people using this medication do not||
0974|075|S|have serious side effects.||
0974|076|S|   Tell your doctor right away if you have any serious side||
0974|077|S|effects, including: fast/pounding/irregular heartbeat,||
0974|078|S|mental/mood changes (such as agitation, confusion, depression,||
0974|079|S|hallucinations, rare thoughts of suicide).||
0974|080|S|   Get medical help right away if you have any very serious side||
0974|081|S|effects, including: chest pain.||
0974|082|S|   A very serious allergic reaction to this drug is rare.||
0974|083|S|However, get medical help right away if you notice any symptoms||
0974|084|S|of a serious allergic reaction, including: fever, swollen lymph||
0974|085|S|nodes, rash, itching/swelling (especially of the||
0974|086|S|face/tongue/throat), severe dizziness, trouble breathing.||
0974|087|S|   This is not a complete list of possible side effects. If you||
0974|088|S|notice other effects not listed above, contact your doctor or||
0974|089|S|pharmacist.||
0974|090|S|   In the US -||
0974|091|S|   Call your doctor for medical advice about side effects. You||
0974|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0974|093|S|www.fda.gov/medwatch.||
0974|094|S|   In Canada - Call your doctor for medical advice about side||
0974|095|S|effects. You may report side effects to Health Canada at||
0974|096|S|1-866-234-2345.||
0974|097|B|||
0974|098|P|PRECAUTIONS:  Before taking armodafinil, tell your doctor or||
0974|099|P|pharmacist if you are allergic to it; or to modafinil; or if you||
0974|100|P|have any other allergies. This product may contain inactive||
0974|101|P|ingredients, which can cause allergic reactions or other||
0974|102|P|problems. Talk to your pharmacist for more details.||
0974|103|P|   Before using this medication, tell your doctor or pharmacist||
0974|104|P|your medical history, especially of: heart problems (such as||
0974|105|P|enlarged heart, mitral valve problem, chest pain, heart attack,||
0974|106|P|irregular heartbeat), heart problems after taking stimulant drugs||
0974|107|P|such as amphetamines (including chest pain, irregular heartbeat),||
0974|108|P|high blood pressure, liver problems, mental/mood disorders (such||
0974|109|P|as depression, mania, psychosis), personal or family history of a||
0974|110|P|substance use disorder (such as overuse of or addiction to||
0974|111|P|drugs/alcohol).||
0974|112|P|   Sleep disorders may reduce your ability to react quickly.||
0974|113|P|Though armodafinil helps keep you awake, you still may not be||
0974|114|P|able to safely do things that require quick reactions (such as||
0974|115|P|driving). This drug may also make you dizzy. Alcohol or marijuana||
0974|116|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
0974|117|P|or do anything that needs alertness until you can do it safely.||
0974|118|P|Avoid alcoholic beverages. Talk to your doctor if you are using||
0974|119|P|marijuana (cannabis).||
0974|120|P|   Before having surgery, tell your doctor or dentist about all||
0974|121|P|the products you use (including prescription drugs,||
0974|122|P|nonprescription drugs, and herbal products).||
0974|123|P|   Tell your doctor if you are pregnant or plan to become||
0974|124|P|pregnant. You should not become pregnant while using armodafinil.||
0974|125|P|Armodafinil may harm an unborn baby. Ask about reliable forms of||
0974|126|P|non-hormonal birth control (such as condoms, diaphragm with||
0974|127|P|spermicide) while using this medication and for 2 months after||
0974|128|P|the last dose. If you become pregnant, talk to your doctor right||
0974|129|P|away about the risks and benefits of this medication.||
0974|130|P|   It is unknown if this drug passes into breast milk. Consult||
0974|131|P|your doctor before breastfeeding.||
0974|132|B|||
0974|133|I|DRUG INTERACTIONS:  See also How to Use section.||
0974|134|I|   Drug interactions may change how your medications work or||
0974|135|I|increase your risk for serious side effects. This document does||
0974|136|I|not contain all possible drug interactions. Keep a list of all||
0974|137|I|the products you use (including prescription/nonprescription||
0974|138|I|drugs and herbal products) and share it with your doctor and||
0974|139|I|pharmacist. Do not start, stop, or change the dosage of any||
0974|140|I|medicines without your doctor's approval.||
0974|141|I|   Some products that may interact with this drug include: street||
0974|142|I|drugs (such as methamphetamine, MDMA/"ecstasy").||
0974|143|I|   This medication may decrease the effectiveness of hormonal||
0974|144|I|birth control such as pills, patch, or ring. This could cause||
0974|145|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0974|146|I|use reliable backup birth control methods while using this||
0974|147|I|medication and for 1 month after the last dose. Also tell your||
0974|148|I|doctor if you have any new spotting or breakthrough bleeding,||
0974|149|I|because these may be signs that your birth control is not working||
0974|150|I|well.||
0974|151|I|   Some products have ingredients that could raise your heart||
0974|152|I|rate or blood pressure. Tell your pharmacist what products you||
0974|153|I|are using, and ask how to use them safely (especially||
0974|154|I|cough-and-cold products or diet aids).||
0974|155|I|   Armodafinil is very similar to modafinil. Do not take||
0974|156|I|medications containing modafinil while using armodafinil.||
0974|157|B|||
0974|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0974|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0974|160|O|poison control center right away. US residents can call||
0974|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0974|162|O|Symptoms of overdose include: fast/irregular heartbeat, severe||
0974|163|O|restlessness, hallucinations.||
0974|164|B|||
0974|165|N|NOTES:  Do not share this medication with others. Sharing it is||
0974|166|N|against the law.||
0974|167|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
0974|168|N|may be done while you are taking this medication. Keep all||
0974|169|N|medical and lab appointments. Consult your doctor for more||
0974|170|N|details.||
0974|171|N|   Follow good sleep habits (such as sleeping in a dark/quiet||
0974|172|N|room, avoiding caffeine close to bedtime) which can help improve||
0974|173|N|your sleep if you have shift work sleep disorder.||
0974|174|B|||
0974|175|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0974|176|D|remember. If it is near the time of the next dose, skip the||
0974|177|D|missed dose. Take your next dose at the regular time. Do not||
0974|178|D|double the dose to catch up. Do not take missed doses close to||
0974|179|D|bedtime because doing so may make it harder to go to sleep.||
0974|180|B|||
0974|181|R|STORAGE:  Store at room temperature away from light and moisture.||
0974|182|R|Do not store in the bathroom. Keep all medications away from||
0974|183|R|children and pets.||
0974|184|R|   Do not flush medications down the toilet or pour them into a||
0974|185|R|drain unless instructed to do so. Properly discard this product||
0974|186|R|when it is expired or no longer needed. Consult your pharmacist||
0974|187|R|or local waste disposal company.||
0974|188|B|||
0974|189|A|Information last revised July 2025.||
0974|190|A|Copyright(c) 2025 First Databank, Inc.||
0974|191|B|||
0975|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0975|002|Z|does NOT have all possible information about this product. This||
0975|003|Z|information does not assure that this product is safe, effective,||
0975|004|Z|or appropriate for you. This information is not individual||
0975|005|Z|medical advice and does not substitute for the advice of your||
0975|006|Z|health care professional. Always ask your health care||
0975|007|Z|professional for complete information about this product and your||
0975|008|Z|specific health needs.||
0975|009|B|||
0975|010|T|PROGESTERONE SUPPOSITORY - VAGINAL||
0975|011|F|(pro-JESS-ter-own)||
0975|012|B|||
0975|013|C|COMMON BRAND NAME(S): Endometrin||
0975|014|B|||
0975|015|U|USES:  This medication contains a hormone called progesterone.||
0975|016|U|Progesterone and other hormones help you become and stay||
0975|017|U|pregnant. This medication is used to increase the level of||
0975|018|U|progesterone in women taking fertility treatments because these||
0975|019|U|treatments tend to decrease progesterone levels.||
0975|020|B|||
0975|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0975|022|H|from your pharmacist before you start using this drug and each||
0975|023|H|time you get a refill. If you have any questions, ask your doctor||
0975|024|H|or pharmacist.||
0975|025|H|   This medication is for vaginal use only. Unwrap the||
0975|026|H|suppository. Following the instructions, use the applicator to||
0975|027|H|insert this medication into the vagina as directed by your||
0975|028|H|doctor, usually 2 or 3 times a day. If you become pregnant,||
0975|029|H|continue to use this medication for up to a total of 10 weeks or||
0975|030|H|as directed by your doctor.||
0975|031|H|   Dosage is based on your medical condition and response to||
0975|032|H|treatment.||
0975|033|H|   To get the most benefit from this medication, use it regularly||
0975|034|H|at evenly spaced intervals. To help you remember, use it at the||
0975|035|H|same times each day.||
0975|036|B|||
0975|037|S|SIDE EFFECTS:  Bloating, stomach/abdominal pain, nausea, breast||
0975|038|S|tenderness, headache, drowsiness, mood swings, irritability, or||
0975|039|S|vaginal discomfort may occur. If any of these effects last or get||
0975|040|S|worse, tell your doctor or pharmacist promptly.||
0975|041|S|   Remember that this medication has been prescribed because your||
0975|042|S|doctor has judged that the benefit to you is greater than the||
0975|043|S|risk of side effects. Many people using this medication do not||
0975|044|S|have serious side effects.||
0975|045|S|   Tell your doctor right away if you have any serious side||
0975|046|S|effects, including: unusual vaginal bleeding, severe mental/mood||
0975|047|S|changes (such as depression), swelling ankles/feet, yellowing||
0975|048|S|eyes/skin, breast lumps.||
0975|049|S|   This medication, especially if used along with an estrogen||
0975|050|S|product, may rarely cause very serious (possibly fatal) problems||
0975|051|S|from blood clots (such as heart attack, stroke, blood clots in||
0975|052|S|the lungs, legs, or eyes). Get medical help right away if you||
0975|053|S|have: chest/jaw/left arm pain, weakness on one side of the body,||
0975|054|S|trouble speaking, sudden vision changes, confusion, sudden/severe||
0975|055|S|headaches, sudden dizziness/fainting, shortness of breath/rapid||
0975|056|S|breathing, pain/swelling/warmth in the groin/calf, unusual||
0975|057|S|sweating.||
0975|058|S|   A very serious allergic reaction to this drug is rare.||
0975|059|S|However, get medical help right away if you notice any symptoms||
0975|060|S|of a serious allergic reaction, including: rash, itching/swelling||
0975|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0975|062|S|breathing.||
0975|063|S|   This is not a complete list of possible side effects. If you||
0975|064|S|notice other effects not listed above, contact your doctor or||
0975|065|S|pharmacist.||
0975|066|S|   In the US -||
0975|067|S|   Call your doctor for medical advice about side effects. You||
0975|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0975|069|S|www.fda.gov/medwatch.||
0975|070|S|   In Canada - Call your doctor for medical advice about side||
0975|071|S|effects. You may report side effects to Health Canada at||
0975|072|S|1-866-234-2345.||
0975|073|B|||
0975|074|P|PRECAUTIONS:  Before using progesterone, tell your doctor or||
0975|075|P|pharmacist if you are allergic to it; or if you have any other||
0975|076|P|allergies. This product may contain inactive ingredients, which||
0975|077|P|can cause allergic reactions or other problems. Talk to your||
0975|078|P|pharmacist for more details.||
0975|079|P|   Before using this medication, tell your doctor or pharmacist||
0975|080|P|your medical history, especially of: blood clots, liver disease,||
0975|081|P|cancer (especially of the breast or other female organs), vaginal||
0975|082|P|bleeding of unknown cause, a loss of pregnancy with some tissue||
0975|083|P|remaining in the uterus ("missed abortion"), an abnormal||
0975|084|P|pregnancy where the fertilized egg is outside of the uterus||
0975|085|P|(ectopic pregnancy), kidney disease, heart disease (such as past||
0975|086|P|heart attacks, heart failure), high blood pressure, seizures,||
0975|087|P|migraine headaches, asthma, depression, diabetes, strokes, high||
0975|088|P|level of fats in the blood (high cholesterol/triglycerides).||
0975|089|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
0975|090|P|can make you more drowsy. Do not drive, use machinery, or do||
0975|091|P|anything that needs alertness or clear vision until you can do it||
0975|092|P|safely. Limit alcoholic beverages. Talk to your doctor if you are||
0975|093|P|using marijuana (cannabis). In general, alcohol is not||
0975|094|P|recommended for pregnant or possibly pregnant women due to||
0975|095|P|increased risk of harm to the baby.||
0975|096|P|   Before having surgery, tell your doctor or dentist about all||
0975|097|P|the products you use (including prescription drugs,||
0975|098|P|nonprescription drugs, and herbal products).||
0975|099|P|   This medication may be used in pregnancy as directed by your||
0975|100|P|doctor. Consult your doctor for more details.||
0975|101|P|   This drug passes into breast milk. Consult your doctor before||
0975|102|P|breastfeeding.||
0975|103|B|||
0975|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0975|105|I|medications work or increase your risk for serious side effects.||
0975|106|I|This document does not contain all possible drug interactions.||
0975|107|I|Keep a list of all the products you use (including||
0975|108|I|prescription/nonprescription drugs and herbal products) and share||
0975|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
0975|110|I|the dosage of any medicines without your doctor's approval.||
0975|111|I|   Do not use other vaginal products during treatment with this||
0975|112|I|medication unless otherwise directed by your doctor. Doing so may||
0975|113|I|affect how well the drug is absorbed by your body.||
0975|114|B|||
0975|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0975|116|O|has overdosed and has serious symptoms such as passing out or||
0975|117|O|trouble breathing, call 911. Otherwise, call a poison control||
0975|118|O|center right away. US residents can call 1-800-222-1222. Canada||
0975|119|O|residents can call 1-844-764-7669.||
0975|120|B|||
0975|121|N|NOTES:  Do not share this medication with others.||
0975|122|N|   Keep all medical and lab appointments.||
0975|123|B|||
0975|124|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0975|125|D|However, do not use more doses in a day than prescribed. If it is||
0975|126|D|near the time of the next dose, skip the missed dose. Use your||
0975|127|D|next dose at the regular time. Do not double the dose to catch||
0975|128|D|up.||
0975|129|B|||
0975|130|R|STORAGE:  Store at room temperature. Keep all medications away||
0975|131|R|from children and pets.||
0975|132|R|   Do not flush medications down the toilet or pour them into a||
0975|133|R|drain unless instructed to do so. Properly discard this product||
0975|134|R|when it is expired or no longer needed. Consult your pharmacist||
0975|135|R|or local waste disposal company.||
0975|136|B|||
0975|137|A|Information last revised June 2025.||
0975|138|A|Copyright(c) 2025 First Databank, Inc.||
0975|139|B|||
0976|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0976|002|Z|does NOT have all possible information about this product. This||
0976|003|Z|information does not assure that this product is safe, effective,||
0976|004|Z|or appropriate for you. This information is not individual||
0976|005|Z|medical advice and does not substitute for the advice of your||
0976|006|Z|health care professional. Always ask your health care||
0976|007|Z|professional for complete information about this product and your||
0976|008|Z|specific health needs.||
0976|009|B|||
0976|010|T|AZITHROMYCIN SOLUTION - OPHTHALMIC||
0976|011|F|(ay-ZITH-roe-MYE-sin)||
0976|012|B|||
0976|013|C|COMMON BRAND NAME(S): Azasite||
0976|014|B|||
0976|015|U|USES:  This medication is used to treat certain eye infections.||
0976|016|U|It is a macrolide antibiotic that works by stopping the growth of||
0976|017|U|bacteria.||
0976|018|U|   This medication treats only bacterial eye infections. It will||
0976|019|U|not work for other types of eye infections. Unnecessary use or||
0976|020|U|misuse of any antibiotic can lead to its decreased effectiveness.||
0976|021|B|||
0976|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0976|023|H|from your pharmacist before you start using azithromycin and each||
0976|024|H|time you get a refill. If you have any questions, ask your doctor||
0976|025|H|or pharmacist.||
0976|026|H|   Use this medication in the affected eye(s) as directed by your||
0976|027|H|doctor, usually twice daily (8 to 12 hours apart) for the first 2||
0976|028|H|days and then once daily for the next 5 days.||
0976|029|H|   To apply eye drops, wash your hands first. To avoid||
0976|030|H|contamination, do not touch the dropper tip or let it touch your||
0976|031|H|eye or any other surface.||
0976|032|H|   Do not wear contact lenses while you are using this medicine||
0976|033|H|or while you have the bacterial eye infection. Sterilize contact||
0976|034|H|lenses according to manufacturer's directions, and check with||
0976|035|H|your doctor before you begin using them again.||
0976|036|H|   If you are using this medication for the first time, hold the||
0976|037|H|dropper upright and remove the cap. This will release any extra||
0976|038|H|pressure in the dropper. Put the cap back on before shaking the||
0976|039|H|dropper.||
0976|040|H|   Before each use, hold the dropper upside down and shake once.||
0976|041|H|With the dropper still upside down, remove the cap. Tilt your||
0976|042|H|head back, look upward, and pull down the lower eyelid to make a||
0976|043|H|pouch. Hold the dropper directly over your eye and place 1 drop||
0976|044|H|into the pouch. Look downward and gently close your eyes for 1 to||
0976|045|H|2 minutes. Place one finger at the corner of your eye (near the||
0976|046|H|nose) and apply gentle pressure. This will prevent the medication||
0976|047|H|from draining out. Try not to blink and do not rub your eye.||
0976|048|H|Repeat these steps for your other eye if so directed.||
0976|049|H|   If you are using another kind of eye medication (such as drops||
0976|050|H|or ointments), wait at least 5 to 10 minutes before applying||
0976|051|H|other medications. Use eye drops before eye ointments to allow||
0976|052|H|the drops to enter the eye.||
0976|053|H|   Wait several minutes for your vision to clear before driving||
0976|054|H|or operating machinery.||
0976|055|H|   Use this medication regularly in order to get the most benefit||
0976|056|H|from it. To help you remember, use it at the same time(s) each||
0976|057|H|day. Keep using it for the full time prescribed. Stopping the||
0976|058|H|medication too soon may result in a return of the infection.||
0976|059|H|   Tell your doctor if your condition lasts or gets worse.||
0976|060|B|||
0976|061|S|SIDE EFFECTS:  Temporary eye irritation/stinging/burning or||
0976|062|S|blurred vision may occur. If any of these effects last or get||
0976|063|S|worse, tell your doctor or pharmacist promptly.||
0976|064|S|   Remember that this medication has been prescribed because your||
0976|065|S|doctor has judged that the benefit to you is greater than the||
0976|066|S|risk of side effects. Many people using this medication do not||
0976|067|S|have serious side effects.||
0976|068|S|   Tell your doctor right away if you have any serious side||
0976|069|S|effects, including: vision changes, eye pain.||
0976|070|S|   Use of this medication for prolonged or repeated periods may||
0976|071|S|result in other types of eye infections, including fungal||
0976|072|S|infections. Contact your doctor if you notice new or worsening||
0976|073|S|eye symptoms.||
0976|074|S|   A very serious allergic reaction to this drug is rare.||
0976|075|S|However, get medical help right away if you notice any symptoms||
0976|076|S|of a serious allergic reaction, including: rash, itching/swelling||
0976|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0976|078|S|breathing.||
0976|079|S|   This is not a complete list of possible side effects. If you||
0976|080|S|notice other effects not listed above, contact your doctor or||
0976|081|S|pharmacist.||
0976|082|S|   In the US -||
0976|083|S|   Call your doctor for medical advice about side effects. You||
0976|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0976|085|S|www.fda.gov/medwatch.||
0976|086|S|   In Canada - Call your doctor for medical advice about side||
0976|087|S|effects. You may report side effects to Health Canada at||
0976|088|S|1-866-234-2345.||
0976|089|B|||
0976|090|P|PRECAUTIONS:  Before using azithromycin, tell your doctor or||
0976|091|P|pharmacist if you are allergic to it; or to other macrolide||
0976|092|P|antibiotics such as erythromycin or clarithromycin; or to||
0976|093|P|ketolide antibiotics such as telithromycin; or if you have any||
0976|094|P|other allergies. This product may contain inactive ingredients,||
0976|095|P|which can cause allergic reactions or other problems. Talk to||
0976|096|P|your pharmacist for more details.||
0976|097|P|   Before using this medication, tell your doctor or pharmacist||
0976|098|P|your medical history, especially of: other eye problems.||
0976|099|P|   After you apply this drug, your vision may become temporarily||
0976|100|P|blurred. Do not drive, use machinery, or do anything that needs||
0976|101|P|clear vision until you can do it safely.||
0976|102|P|   During pregnancy, this medication should be used only when||
0976|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
0976|104|P|   It is unknown if azithromycin passes into breast milk. Consult||
0976|105|P|your doctor before breastfeeding.||
0976|106|B|||
0976|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0976|108|I|medications work or increase your risk for serious side effects.||
0976|109|I|This document does not contain all possible drug interactions.||
0976|110|I|Keep a list of all the products you use (including||
0976|111|I|prescription/nonprescription drugs and herbal products) and share||
0976|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
0976|113|I|the dosage of any medicines without your doctor's approval.||
0976|114|B|||
0976|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0976|116|O|has overdosed and has serious symptoms such as passing out or||
0976|117|O|trouble breathing, call 911. Otherwise, call a poison control||
0976|118|O|center right away. US residents can call 1-800-222-1222. Canada||
0976|119|O|residents can call 1-844-764-7669.||
0976|120|B|||
0976|121|N|NOTES:  Do not share this medication with others.||
0976|122|N|   This medication has been prescribed for your current condition||
0976|123|N|only. Throw away the unused medication after treatment is||
0976|124|N|completed or after 14 days (see also Storage section). Do not use||
0976|125|N|it later for another infection unless your doctor tells you to.||
0976|126|B|||
0976|127|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0976|128|D|If it is near the time of the next dose, skip the missed dose.||
0976|129|D|Use your next dose at the regular time. Do not double the dose to||
0976|130|D|catch up.||
0976|131|B|||
0976|132|R|STORAGE:  Store the unopened bottle in the refrigerator. Store||
0976|133|R|the opened bottle in the refrigerator or at room temperature.||
0976|134|R|Once the bottle is opened, this medication expires after 14 days.||
0976|135|R|Keep all medications away from children and pets.||
0976|136|R|   Do not flush medications down the toilet or pour them into a||
0976|137|R|drain unless instructed to do so. Properly discard this product||
0976|138|R|when it is expired or no longer needed. Consult your pharmacist||
0976|139|R|or local waste disposal company.||
0976|140|B|||
0976|141|A|Information last revised April 2025.||
0976|142|A|Copyright(c) 2025 First Databank, Inc.||
0976|143|B|||
0978|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0978|002|Z|does NOT have all possible information about this product. This||
0978|003|Z|information does not assure that this product is safe, effective,||
0978|004|Z|or appropriate for you. This information is not individual||
0978|005|Z|medical advice and does not substitute for the advice of your||
0978|006|Z|health care professional. Always ask your health care||
0978|007|Z|professional for complete information about this product and your||
0978|008|Z|specific health needs.||
0978|009|B|||
0978|010|T|TEMSIROLIMUS - INJECTION||
0978|011|F|(tem-sir-oh-LEE-muss)||
0978|012|B|||
0978|013|C|COMMON BRAND NAME(S): Torisel||
0978|014|B|||
0978|015|U|USES:  This medication is used to treat kidney cancer. It works||
0978|016|U|by slowing or stopping the growth of cancer cells.||
0978|017|B|||
0978|018|H|HOW TO USE:  This medication is given by injection into a vein by||
0978|019|H|a health care professional. It is given as directed by your||
0978|020|H|doctor, usually once a week (over 30 to 60 minutes). The dosage||
0978|021|H|is based on your medical condition, response to treatment, and||
0978|022|H|other medications you may be taking. Be sure to tell your doctor||
0978|023|H|and pharmacist about all the products you use (including||
0978|024|H|prescription drugs, nonprescription drugs, and herbal products).||
0978|025|H|   Infusion reactions may happen during the infusion of this||
0978|026|H|drug. Your doctor may prescribe other medications (such as||
0978|027|H|diphenhydramine) before each treatment to help prevent these side||
0978|028|H|effects. Tell your doctor right away if you have any symptoms of||
0978|029|H|infusion reactions such as flushing, chest pain, shortness of||
0978|030|H|breath, or dizziness. Your doctor may give you other medications||
0978|031|H|to help with these side effects or may slow down or stop your||
0978|032|H|treatment for some time.||
0978|033|H|   Use this medication regularly to get the most benefit from it.||
0978|034|H|To help you remember, mark your calendar with a reminder.||
0978|035|B|||
0978|036|S|SIDE EFFECTS:  See also How to Use section.||
0978|037|S|   Pain/sores in the mouth or throat, nausea, vomiting, diarrhea,||
0978|038|S|headache, changes in taste, weakness, and loss of appetite may||
0978|039|S|occur. If these effects last or get worse, tell your doctor or||
0978|040|S|pharmacist promptly.||
0978|041|S|   People using this medication may have serious side effects.||
0978|042|S|However, you have been prescribed this drug because your doctor||
0978|043|S|has judged that the benefit to you is greater than the risk of||
0978|044|S|side effects. Careful monitoring by your doctor may decrease your||
0978|045|S|risk.||
0978|046|S|   Tell your doctor right away if you have any serious side||
0978|047|S|effects, including: flushing, slow wound healing, swelling||
0978|048|S|ankles/feet, eye redness/itching, easy bruising/bleeding, unusual||
0978|049|S|tiredness, muscle cramps, fast/pounding heartbeat,||
0978|050|S|pain/redness/swelling of arms or legs, missed/heavy/painful||
0978|051|S|periods.||
0978|052|S|   This medication may lower your ability to fight infections.||
0978|053|S|This may make you more likely to get a serious (rarely fatal)||
0978|054|S|infection or make any infection you have worse. Tell your doctor||
0978|055|S|right away if you have any signs of infection (such as sore||
0978|056|S|throat that doesn't go away, fever, chills).||
0978|057|S|   Temsirolimus may cause your cholesterol/triglycerides or blood||
0978|058|S|sugar to increase. You may be required to have your||
0978|059|S|cholesterol/triglycerides or blood sugar checked periodically.||
0978|060|S|You may need medication to control your cholesterol/triglycerides||
0978|061|S|or blood sugar. Tell your doctor or pharmacist if you experience||
0978|062|S|symptoms of high blood sugar, including increased thirst/hunger,||
0978|063|S|frequent urination.||
0978|064|S|   This medication can rarely cause serious (rarely fatal) lung,||
0978|065|S|kidney, or intestinal problems. Tell your doctor right away if||
0978|066|S|you notice any symptoms of lung, kidney, or intestinal problems,||
0978|067|S|including: shortness of breath, rapid breathing, cough, change in||
0978|068|S|the amount of urine, frothy urine, severe abdominal pain,||
0978|069|S|black/bloody stool.||
0978|070|S|   This drug increases the risk of a possibly fatal brain||
0978|071|S|infection (PML - progressive multifocal leukoencephalopathy).||
0978|072|S|Tell your doctor right away if you have any of these symptoms:||
0978|073|S|clumsiness, sudden change in your thinking (such as confusion,||
0978|074|S|difficulty concentrating), difficulty moving muscles, seizure,||
0978|075|S|difficulty speaking.||
0978|076|S|   A very serious allergic reaction to this drug is rare.||
0978|077|S|However, get medical help right away if you notice any symptoms||
0978|078|S|of a serious allergic reaction, including: rash, itching/swelling||
0978|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0978|080|S|breathing.||
0978|081|S|   Temsirolimus can commonly cause a mild rash that is usually||
0978|082|S|not serious. However, you may not be able to tell it apart from a||
0978|083|S|rare rash that could be a sign of a severe allergic reaction. Get||
0978|084|S|medical help right away if you develop any rash.||
0978|085|S|   This is not a complete list of possible side effects. If you||
0978|086|S|notice other effects not listed above, contact your doctor or||
0978|087|S|pharmacist.||
0978|088|S|   In the US -||
0978|089|S|   Call your doctor for medical advice about side effects. You||
0978|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0978|091|S|www.fda.gov/medwatch.||
0978|092|S|   In Canada - Call your doctor for medical advice about side||
0978|093|S|effects. You may report side effects to Health Canada at||
0978|094|S|1-866-234-2345.||
0978|095|B|||
0978|096|P|PRECAUTIONS:  Before receiving temsirolimus, tell your doctor or||
0978|097|P|pharmacist if you are allergic to it; or to sirolimus; or if you||
0978|098|P|have any other allergies. This product may contain inactive||
0978|099|P|ingredients, which can cause allergic reactions or other||
0978|100|P|problems. Talk to your pharmacist for more details.||
0978|101|P|   Before using this medication, tell your doctor or pharmacist||
0978|102|P|your medical history, especially of: diabetes, high||
0978|103|P|cholesterol/triglyceride levels, liver disease, kidney disease,||
0978|104|P|recent/current infections or wounds, recent surgery, brain||
0978|105|P|cancer.||
0978|106|P|   Temsirolimus can make you more likely to get infections or may||
0978|107|P|make current infections worse. Stay away from anyone who has an||
0978|108|P|infection that may easily spread (such as chickenpox, COVID-19,||
0978|109|P|measles, flu). Talk to your doctor if you have been exposed to an||
0978|110|P|infection or for more details.||
0978|111|P|   Tell your health care professional that you are using||
0978|112|P|temsirolimus before having any immunizations/vaccinations. Avoid||
0978|113|P|contact with people who have recently received live vaccines||
0978|114|P|(such as flu vaccine inhaled through the nose).||
0978|115|P|   Before having surgery, tell your doctor or dentist about all||
0978|116|P|the products you use (including prescription drugs,||
0978|117|P|nonprescription drugs, and herbal products).||
0978|118|P|   Pain or sores in the mouth and throat may occur. Brush your||
0978|119|P|teeth gently/carefully, avoid using mouthwash that contains||
0978|120|P|alcohol, and rinse your mouth often with cool water mixed with||
0978|121|P|baking soda or salt. It may also be best to eat soft, moist||
0978|122|P|foods.||
0978|123|P|   Tell your doctor if you are pregnant or plan to become||
0978|124|P|pregnant. You should not become pregnant while using||
0978|125|P|temsirolimus. Temsirolimus may harm an unborn baby. Men and women||
0978|126|P|using this medication should ask about reliable forms of birth||
0978|127|P|control during treatment and for at least 3 months after the last||
0978|128|P|dose. If you or your partner becomes pregnant, talk to your||
0978|129|P|doctor right away about the risks and benefits of this||
0978|130|P|medication.||
0978|131|P|   It is unknown if this drug passes into breast milk. Because of||
0978|132|P|the possible risk to the infant, breastfeeding is not recommended||
0978|133|P|while using this drug and for 3 weeks after the last dose.||
0978|134|P|Consult your doctor before breastfeeding.||
0978|135|B|||
0978|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0978|137|I|medications work or increase your risk for serious side effects.||
0978|138|I|This document does not contain all possible drug interactions.||
0978|139|I|Keep a list of all the products you use (including||
0978|140|I|prescription/nonprescription drugs and herbal products) and share||
0978|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
0978|142|I|the dosage of any medicines without your doctor's approval.||
0978|143|I|   Some products that may interact with this drug include: ACE||
0978|144|I|inhibitors (such as benazepril, lisinopril), "blood thinners"||
0978|145|I|(such as warfarin, enoxaparin), other drugs that weaken the||
0978|146|I|immune system/increase the risk of infection (such as||
0978|147|I|cyclosporine, natalizumab, rituximab, tacrolimus), sunitinib.||
0978|148|I|   Other medications can affect the removal of temsirolimus from||
0978|149|I|your body, which may affect how temsirolimus works. Examples||
0978|150|I|include azole antifungals (such as itraconazole, ketoconazole,||
0978|151|I|voriconazole), enzalutamide, macrolide antibiotics (such as||
0978|152|I|clarithromycin, erythromycin), mifepristone, rifamycins (such as||
0978|153|I|rifampin, rifabutin), ritonavir, St. John's wort, among others.||
0978|154|I|   Temsirolimus is very similar to sirolimus. Do not use||
0978|155|I|medications containing sirolimus while using temsirolimus.||
0978|156|B|||
0978|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0978|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0978|159|O|poison control center right away. US residents can call||
0978|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0978|161|O|Symptoms of overdose may include: seizures, mental/mood changes,||
0978|162|O|trouble breathing.||
0978|163|B|||
0978|164|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
0978|165|N|cholesterol/triglyceride levels, blood glucose levels,||
0978|166|N|liver/kidney function, chest X-ray, urine tests) should be done||
0978|167|N|before you start using this medication and while you are using||
0978|168|N|it. Keep all medical and lab appointments. Consult your doctor||
0978|169|N|for more details.||
0978|170|B|||
0978|171|D|MISSED DOSE:  It is important to get each dose of this medication||
0978|172|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0978|173|D|right away for a new dosing schedule.||
0978|174|B|||
0978|175|R|STORAGE:  Not applicable. This medication is given in a clinic||
0978|176|R|and will not be stored at home.||
0978|177|B|||
0978|178|M|MEDICAL ALERT:  Your condition can cause complications in a||
0978|179|M|medical emergency. For information about enrolling in MedicAlert,||
0978|180|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0978|181|B|||
0978|182|A|Information last revised April 2025.||
0978|183|A|Copyright(c) 2025 First Databank, Inc.||
0978|184|B|||
0980|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0980|002|Z|does NOT have all possible information about this product. This||
0980|003|Z|information does not assure that this product is safe, effective,||
0980|004|Z|or appropriate for you. This information is not individual||
0980|005|Z|medical advice and does not substitute for the advice of your||
0980|006|Z|health care professional. Always ask your health care||
0980|007|Z|professional for complete information about this product and your||
0980|008|Z|specific health needs.||
0980|009|B|||
0980|010|T|TACROLIMUS EXTENDED-RELEASE - ORAL||
0980|011|F|(ta-KROE-li-mus)||
0980|012|B|||
0980|013|C|COMMON BRAND NAME(S): Astagraf XL, Envarsus XR||
0980|014|B|||
0980|015|W|WARNING:  Tacrolimus lowers the body's ability to fight an||
0980|016|W|infection/disease (immunosuppression). This effect may increase||
0980|017|W|your risk of developing an infection or certain types of cancer||
0980|018|W|(such as skin cancer, lymphoma). To reduce the risk of these||
0980|019|W|serious side effects, take this medication at the lowest||
0980|020|W|effective dose as directed by your doctor. Keep all medical and||
0980|021|W|lab appointments.||
0980|022|W|   Tell your doctor right away if you develop any of the||
0980|023|W|following: unusual skin changes, change in the appearance/size of||
0980|024|W|moles, unusual growths/lumps, swollen lymph nodes, night sweats,||
0980|025|W|unexplained weight loss, signs of infection (such as sore throat||
0980|026|W|that doesn't go away, fever, chills).||
0980|027|W|   This medication may increase the risk of death when it is used||
0980|028|W|by women to prevent organ rejection after a liver transplant.||
0980|029|W|Discuss the risks and benefits of this medication with the||
0980|030|W|doctor.||
0980|031|B|||
0980|032|U|USES:  Tacrolimus is used with other medications to prevent||
0980|033|U|rejection of a kidney transplant. This medication belongs to a||
0980|034|U|class of drugs known as immunosuppressants. It works by weakening||
0980|035|U|your body's defense system (immune system) to help your body||
0980|036|U|accept the new organ as if it were your own.||
0980|037|B|||
0980|038|V|OTHER USES:  This section contains uses of this drug that are not||
0980|039|V|listed in the approved professional labeling for the drug but||
0980|040|V|that may be prescribed by your health care professional. Use this||
0980|041|V|drug for a condition that is listed in this section only if it||
0980|042|V|has been so prescribed by your health care professional.||
0980|043|V|   This drug may also be used to reduce the risk of rejection of||
0980|044|V|other types of transplant (such as heart, liver). See also||
0980|045|V|Warning section.||
0980|046|B|||
0980|047|H|HOW TO USE:  Read the Medication Guide and, if available, the||
0980|048|H|Patient Information Leaflet provided by your pharmacist before||
0980|049|H|you start taking tacrolimus and each time you get a refill. If||
0980|050|H|you have any questions, ask your doctor or pharmacist.||
0980|051|H|   Take this medication by mouth on an empty stomach (1 hour||
0980|052|H|before or 2 hours after a meal) as directed by your doctor,||
0980|053|H|usually once daily in the morning. Talk to your doctor about how||
0980|054|H|to take this medication if you have nausea or an upset stomach.||
0980|055|H|   Swallow the medication whole. Do not crush or chew. Doing so||
0980|056|H|can release all of the drug at once, increasing the risk of side||
0980|057|H|effects.||
0980|058|H|   The dosage is based on your weight, medical condition, lab||
0980|059|H|tests (such as tacrolimus trough levels), response to treatment,||
0980|060|H|and previous dose of tacrolimus (if switching from the form of||
0980|061|H|this medication that is taken twice daily).||
0980|062|H|   Tacrolimus is available in different formulations (such as||
0980|063|H|immediate and extended-release). Do not switch between different||
0980|064|H|forms of tacrolimus without consulting your doctor.||
0980|065|H|   Do not increase your dose or take this medication more often||
0980|066|H|without your doctor's approval. Your condition will not improve||
0980|067|H|any faster and the risk of serious side effects may be increased.||
0980|068|H|Also, do not stop taking this medication without your doctor's||
0980|069|H|approval.||
0980|070|H|   Take this medication regularly in order to get the most||
0980|071|H|benefit from it. It is important to take all doses on time to||
0980|072|H|keep the amount of medicine in your body at a constant level.||
0980|073|H|Remember to take it at the same time each day.||
0980|074|H|   Avoid eating grapefruit or drinking grapefruit juice while||
0980|075|H|using this medication unless your doctor or pharmacist says you||
0980|076|H|may do so safely. Grapefruit can increase the chance of side||
0980|077|H|effects with this medicine. Ask your doctor or pharmacist for||
0980|078|H|more details.||
0980|079|H|   Since this drug can be absorbed through the skin and lungs and||
0980|080|H|may harm an unborn baby, women who are pregnant or who may become||
0980|081|H|pregnant should not handle this medication or breathe the dust||
0980|082|H|from the tablets.||
0980|083|H|   Tell your doctor if your condition gets worse.||
0980|084|B|||
0980|085|S|SIDE EFFECTS:  See also Warning section.||
0980|086|S|   Shaking, headache, diarrhea, nausea/vomiting, upset stomach,||
0980|087|S|and trouble sleeping may occur. If any of these effects last or||
0980|088|S|get worse, tell your doctor or pharmacist promptly.||
0980|089|S|   Remember that this medication has been prescribed because your||
0980|090|S|doctor has judged that the benefit to you is greater than the||
0980|091|S|risk of side effects. Many people using this medication do not||
0980|092|S|have serious side effects.||
0980|093|S|   Tell your doctor right away if you have any serious side||
0980|094|S|effects, including: signs of kidney problems (such as change in||
0980|095|S|the amount of urine), mental/mood changes, hearing problems (such||
0980|096|S|as hearing loss, ringing in the ears), numbness/tingling of the||
0980|097|S|hands/feet, dizziness, pain/redness/swelling of arms or legs,||
0980|098|S|easy bruising/bleeding, signs of liver problems (such as||
0980|099|S|nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
0980|100|S|urine, stomach/abdominal pain), muscle weakness, severe leg pain,||
0980|101|S|symptoms of heart failure (such as shortness of breath, swelling||
0980|102|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
0980|103|S|   This medication may also increase your risk of getting a rare||
0980|104|S|but very serious (sometimes fatal) brain infection (progressive||
0980|105|S|multifocal leukoencephalopathy-PML). Get medical help right away||
0980|106|S|if any of these rare but very serious side effects occur:||
0980|107|S|clumsiness, loss of coordination, weakness, sudden change in your||
0980|108|S|thinking (such as confusion, difficulty concentrating),||
0980|109|S|difficulty moving your muscles, problems with speech, seizure,||
0980|110|S|vision changes.||
0980|111|S|   Get medical help right away if you have any very serious side||
0980|112|S|effects, including: fainting, fast/irregular heartbeat, severe||
0980|113|S|dizziness, chest/jaw/left arm pain, black stools, vomit that||
0980|114|S|looks like coffee grounds.||
0980|115|S|   This medication may raise your blood pressure. Check your||
0980|116|S|blood pressure regularly and tell your doctor if the results are||
0980|117|S|high. Your doctor may control your blood pressure with||
0980|118|S|medication.||
0980|119|S|   Tacrolimus may cause diabetes. Tell your doctor or pharmacist||
0980|120|S|if you experience symptoms of high blood sugar such as increased||
0980|121|S|thirst/hunger, frequent urination.||
0980|122|S|   A very serious allergic reaction to this drug is rare.||
0980|123|S|However, get medical help right away if you notice any symptoms||
0980|124|S|of a serious allergic reaction, including: rash, itching/swelling||
0980|125|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0980|126|S|breathing.||
0980|127|S|   This is not a complete list of possible side effects. If you||
0980|128|S|notice other effects not listed above, contact your doctor or||
0980|129|S|pharmacist.||
0980|130|S|   In the US -||
0980|131|S|   Call your doctor for medical advice about side effects. You||
0980|132|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0980|133|S|www.fda.gov/medwatch.||
0980|134|S|   In Canada - Call your doctor for medical advice about side||
0980|135|S|effects. You may report side effects to Health Canada at||
0980|136|S|1-866-234-2345.||
0980|137|B|||
0980|138|P|PRECAUTIONS:  Before taking tacrolimus, tell your doctor or||
0980|139|P|pharmacist if you are allergic to it; or to other macrolide||
0980|140|P|medications (such as sirolimus); or if you have any other||
0980|141|P|allergies. This product may contain inactive ingredients, which||
0980|142|P|can cause allergic reactions or other problems. Talk to your||
0980|143|P|pharmacist for more details.||
0980|144|P|   Before using this medication, tell your doctor or pharmacist||
0980|145|P|your medical history, especially of: mineral imbalances (such as||
0980|146|P|high potassium), kidney disease, any recent/current infections,||
0980|147|P|cancer, liver disease, high blood pressure, diabetes.||
0980|148|P|   Tacrolimus may cause a condition that affects the heart rhythm||
0980|149|P|(QT prolongation). QT prolongation can rarely cause serious||
0980|150|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0980|151|P|as severe dizziness, fainting) that need medical attention right||
0980|152|P|away.||
0980|153|P|   The risk of QT prolongation may be increased if you have||
0980|154|P|certain medical conditions or are taking other drugs that may||
0980|155|P|cause QT prolongation. Before using tacrolimus, tell your doctor||
0980|156|P|or pharmacist of all the drugs you take and if you have any of||
0980|157|P|the following conditions: certain heart problems (heart failure,||
0980|158|P|slow heartbeat, QT prolongation in the EKG), family history of||
0980|159|P|certain heart problems (QT prolongation in the EKG, sudden||
0980|160|P|cardiac death).||
0980|161|P|   Low levels of potassium or magnesium in the blood may also||
0980|162|P|increase your risk of QT prolongation. This risk may increase if||
0980|163|P|you use certain drugs (such as diuretics/"water pills") or if you||
0980|164|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0980|165|P|Talk to your doctor about using tacrolimus safely.||
0980|166|P|   This medication may increase your risk of developing skin||
0980|167|P|cancer. Limit your time in the sun. Avoid tanning booths and||
0980|168|P|sunlamps. Use sunscreen and wear protective clothing when||
0980|169|P|outdoors.||
0980|170|P|   Tacrolimus can make you more likely to get infections or may||
0980|171|P|make current infections worse. Stay away from anyone who has an||
0980|172|P|infection that may easily spread (such as chickenpox, COVID-19,||
0980|173|P|measles, flu). Talk to your doctor if you have been exposed to an||
0980|174|P|infection or for more details.||
0980|175|P|   Tell your health care professional that you are using||
0980|176|P|tacrolimus before having any immunizations/vaccinations. Avoid||
0980|177|P|contact with people who have recently received live vaccines||
0980|178|P|(such as flu vaccine inhaled through the nose).||
0980|179|P|   This drug may increase your potassium levels. Before using||
0980|180|P|potassium supplements or salt substitutes that contain potassium,||
0980|181|P|consult your doctor or pharmacist.||
0980|182|P|   Before having surgery, tell your doctor or dentist about all||
0980|183|P|the products you use (including prescription drugs,||
0980|184|P|nonprescription drugs, and herbal products).||
0980|185|P|   Older adults may be more sensitive to the side effects of this||
0980|186|P|drug, especially QT prolongation (see above).||
0980|187|P|   Since this drug can be absorbed through the skin and lungs and||
0980|188|P|may harm an unborn baby, women who are pregnant or who may become||
0980|189|P|pregnant should not handle this medication or breathe the dust||
0980|190|P|from the tablets.||
0980|191|P|   Tell your doctor if you are pregnant or plan to become||
0980|192|P|pregnant. You should not become pregnant while using tacrolimus.||
0980|193|P|Tacrolimus may harm an unborn baby. Men and women using this||
0980|194|P|medication should ask about reliable forms of birth control||
0980|195|P|before and during treatment. If you or your partner becomes||
0980|196|P|pregnant, talk to your doctor right away about the risks and||
0980|197|P|benefits of this medication.||
0980|198|P|   This drug passes into breast milk and the effect on a nursing||
0980|199|P|infant is unknown. Consult your doctor before breastfeeding.||
0980|200|B|||
0980|201|I|DRUG INTERACTIONS:  See also How to Use section.||
0980|202|I|   Drug interactions may change how your medications work or||
0980|203|I|increase your risk for serious side effects. This document does||
0980|204|I|not contain all possible drug interactions. Keep a list of all||
0980|205|I|the products you use (including prescription/nonprescription||
0980|206|I|drugs and herbal products) and share it with your doctor and||
0980|207|I|pharmacist. Do not start, stop, or change the dosage of any||
0980|208|I|medicines without your doctor's approval.||
0980|209|I|   Some products that may interact with this drug include:||
0980|210|I|aluminum/magnesium antacid, cyclosporine, sirolimus,||
0980|211|I|temsirolimus, ziprasidone, other drugs that may increase the||
0980|212|I|level of potassium in the blood (such as "water pills" including||
0980|213|I|amiloride, spironolactone), other drugs that weaken the immune||
0980|214|I|system/increase the risk of infection (such as natalizumab,||
0980|215|I|rituximab).||
0980|216|I|   Avoid alcohol when using this medication because it may cause||
0980|217|I|the medication to be released too quickly and increase the risk||
0980|218|I|of side effects.||
0980|219|I|   Other medications can affect the removal of tacrolimus from||
0980|220|I|your body, which may affect how tacrolimus works. Examples||
0980|221|I|include azole antifungals (such as itraconazole, voriconazole),||
0980|222|I|cimetidine, danazol, ethinyl estradiol, methylprednisolone,||
0980|223|I|nefazodone, HIV protease inhibitors (such as nelfinavir),||
0980|224|I|rifamycins (such as rifampin, rifabutin), ritonavir, St. John's||
0980|225|I|wort, certain anti-seizure drugs (such as phenobarbital,||
0980|226|I|phenytoin), among others.||
0980|227|B|||
0980|228|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0980|229|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0980|230|O|poison control center right away. US residents can call||
0980|231|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0980|232|B|||
0980|233|N|NOTES:  Lab and/or medical tests (such as potassium levels, blood||
0980|234|N|pressure, blood sugar, tacrolimus trough level, kidney/liver||
0980|235|N|function) will be done while you are taking this medication. Keep||
0980|236|N|all medical and lab appointments. Consult your doctor for more||
0980|237|N|details.||
0980|238|N|   If you have had an organ transplant, it is recommended that||
0980|239|N|you attend a transplant education class or support group. Learn||
0980|240|N|the signs of organ rejection such as a feeling of being ill,||
0980|241|N|fever, or tenderness/pain around the transplanted organ. Tell||
0980|242|N|your doctor right away if you notice any of these signs.||
0980|243|B|||
0980|244|D|MISSED DOSE:  If you take the extended-release capsules: If you||
0980|245|D|miss a dose, take it as soon as you remember. If it is more than||
0980|246|D|14 hours after the missed dose, skip the missed dose. Take your||
0980|247|D|next dose at the regular time. Do not double the dose to catch||
0980|248|D|up.||
0980|249|D|   If you take the extended-release tablets: If you miss a dose,||
0980|250|D|take it as soon as you remember. If it is more than 15 hours||
0980|251|D|after the missed dose, skip the missed dose. Take your next dose||
0980|252|D|at the regular time. Do not double the dose to catch up.||
0980|253|B|||
0980|254|R|STORAGE:  Store at room temperature away from light and moisture.||
0980|255|R|Do not store in the bathroom. Keep all medications away from||
0980|256|R|children and pets.||
0980|257|R|   Do not flush medications down the toilet or pour them into a||
0980|258|R|drain unless instructed to do so. Properly discard this product||
0980|259|R|when it is expired or no longer needed. Consult your pharmacist||
0980|260|R|or local waste disposal company.||
0980|261|B|||
0980|262|M|MEDICAL ALERT:  Your condition can cause complications in a||
0980|263|M|medical emergency. For information about enrolling in MedicAlert,||
0980|264|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0980|265|B|||
0980|266|A|Information last revised April 2025.||
0980|267|A|Copyright(c) 2025 First Databank, Inc.||
0980|268|B|||
0981|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0981|002|Z|does NOT have all possible information about this product. This||
0981|003|Z|information does not assure that this product is safe, effective,||
0981|004|Z|or appropriate for you. This information is not individual||
0981|005|Z|medical advice and does not substitute for the advice of your||
0981|006|Z|health care professional. Always ask your health care||
0981|007|Z|professional for complete information about this product and your||
0981|008|Z|specific health needs.||
0981|009|B|||
0981|010|T|SODIUM PHOSPHATE MONOBASIC/DIBASIC SOLUTION - ORAL||
0981|011|F|(SOE-dee-um FOS-fate MAW-no-BAY-sik/dye-BAY-sik)||
0981|012|B|||
0981|013|W|WARNING:  Rarely, serious kidney problems have occurred with the||
0981|014|W|use of this product. Heart failure, kidney disease, bowel||
0981|015|W|problems (such as blockage, ulcerative colitis), or being older||
0981|016|W|than 55 years can increase the risk. Taking certain medications||
0981|017|W|that can affect the kidneys (see Drug Interactions section) can||
0981|018|W|also increase the risk. If any of these cautions apply to you,||
0981|019|W|talk with your doctor before using this drug.||
0981|020|B|||
0981|021|U|USES:  This medication may be used to relieve occasional||
0981|022|U|constipation. However, when treating constipation, you should use||
0981|023|U|milder products (such as stool softeners, bulk-forming laxatives)||
0981|024|U|whenever possible. Talk to your doctor or pharmacist about other||
0981|025|U|treatment options. Your doctor may also prescribe this product||
0981|026|U|(usually along with other products) to clean stool from the||
0981|027|U|intestines before surgery or certain bowel procedures (such as||
0981|028|U|colonoscopy, radiography). Use it only as directed by your||
0981|029|U|doctor.||
0981|030|U|   Sodium phosphate is a saline laxative that is thought to work||
0981|031|U|by increasing fluid in the small intestine. It usually results in||
0981|032|U|a bowel movement after 30 minutes to 6 hours.||
0981|033|U|   Do not use this medication in children younger than 5 years of||
0981|034|U|age unless directed by the doctor.||
0981|035|B|||
0981|036|H|HOW TO USE:  Read and follow all directions on the product||
0981|037|H|package. If you have any questions, ask your doctor or||
0981|038|H|pharmacist. To improve the taste, this product may be chilled in||
0981|039|H|the refrigerator before use. Do not freeze. Mix your dose in 8||
0981|040|H|ounces (240 milliliters) of liquid and drink the mixed solution.||
0981|041|H|Since your bowel movements can be very large/watery, drink plenty||
0981|042|H|of clear liquids so that you do not become dehydrated.||
0981|043|H|   If your doctor has directed you to use this product before||
0981|044|H|surgery or a bowel procedure, your doctor should tell you how||
0981|045|H|long before the surgery/procedure you should take this product.||
0981|046|H|Follow your doctor's directions closely. After taking the||
0981|047|H|medication, drink plenty of clear liquids as directed by your||
0981|048|H|doctor. Doing so will help prevent serious side effects (such as||
0981|049|H|kidney problems, dehydration). Talk with your doctor about types||
0981|050|H|of liquids you can drink before your procedure.||
0981|051|H|   Dosage is based on your medical condition, procedure, age, and||
0981|052|H|response to treatment. Do not take more of this medication than||
0981|053|H|directed, use this medication more often than once in 24 hours,||
0981|054|H|or use this medication for more than 3 days unless directed by||
0981|055|H|your doctor. Also, do not use any other laxative products while||
0981|056|H|using this product unless directed by your doctor. Doing so may||
0981|057|H|increase your risk for severe side effects.||
0981|058|H|   If you are seeing a doctor for any medical problems, are on a||
0981|059|H|salt-restricted diet, or if you are taking any other medications,||
0981|060|H|do not use this medication to treat yourself for constipation||
0981|061|H|without consulting your doctor.||
0981|062|H|   This medication may cause a condition known as laxative||
0981|063|H|dependence, especially if it has been used regularly for a long||
0981|064|H|time. In such cases, ongoing constipation and loss of normal||
0981|065|H|bowel function may occur. For most people with occasional||
0981|066|H|constipation, a bulk-forming laxative (such as psyllium) or a||
0981|067|H|stool softener (such as docusate) is a better and safer product.||
0981|068|H|To prevent laxative dependence, consult your doctor if you need||
0981|069|H|to use this medication or other laxative products for more than 7||
0981|070|H|days.||
0981|071|H|   Stop using this product and contact your doctor promptly if||
0981|072|H|you do not have a bowel movement within 6 hours of using this||
0981|073|H|product, if you have symptoms of dehydration (see Side Effects||
0981|074|H|section), if you bleed from the rectum, or if you think you may||
0981|075|H|have a serious medical problem.||
0981|076|B|||
0981|077|S|SIDE EFFECTS:  Mild abdominal discomfort/cramps, gas, or nausea||
0981|078|S|may occur. If any of these effects last or get worse, contact||
0981|079|S|your doctor or pharmacist promptly.||
0981|080|S|   If your doctor has directed you to use this product, remember||
0981|081|S|that your doctor has judged that the benefit to you is greater||
0981|082|S|than the risk of side effects. Many people using this product do||
0981|083|S|not have serious side effects.||
0981|084|S|   Diarrhea that doesn't stop may result in dehydration. This may||
0981|085|S|cause serious side effects to the kidneys and heart. Contact your||
0981|086|S|doctor promptly if you notice any symptoms of dehydration, such||
0981|087|S|as unusual dry mouth/increased thirst, lack of tears,||
0981|088|S|dizziness/lightheadedness, or pale/wrinkled skin.||
0981|089|S|   Tell your doctor right away if you have any serious side||
0981|090|S|effects, including: stomach/abdominal pain that is severe or||
0981|091|S|doesn't go away, diarrhea that doesn't stop, signs of kidney||
0981|092|S|problems (such as change in the amount of urine), bloody stools,||
0981|093|S|rectal bleeding, mental/mood changes (such as confusion, unusual||
0981|094|S|drowsiness), muscle weakness/spasm, swelling of the||
0981|095|S|hands/ankles/feet.||
0981|096|S|   Get medical help right away if you have any very serious side||
0981|097|S|effects, including: chest pain, slow/irregular/fast heartbeat,||
0981|098|S|seizures.||
0981|099|S|   A very serious allergic reaction to this drug is rare.||
0981|100|S|However, get medical help right away if you notice any symptoms||
0981|101|S|of a serious allergic reaction, including: rash, itching/swelling||
0981|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0981|103|S|breathing.||
0981|104|S|   This is not a complete list of possible side effects. If you||
0981|105|S|notice other effects not listed above, contact your doctor or||
0981|106|S|pharmacist.||
0981|107|S|   In the US -||
0981|108|S|   Call your doctor for medical advice about side effects. You||
0981|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0981|110|S|www.fda.gov/medwatch.||
0981|111|S|   In Canada - Call your doctor for medical advice about side||
0981|112|S|effects. You may report side effects to Health Canada at||
0981|113|S|1-866-234-2345.||
0981|114|B|||
0981|115|P|PRECAUTIONS:  Before taking sodium phosphate, tell your doctor or||
0981|116|P|pharmacist if you are allergic to it; or if you have any other||
0981|117|P|allergies. This product may contain inactive ingredients, which||
0981|118|P|can cause allergic reactions or other problems. Talk to your||
0981|119|P|pharmacist for more details.||
0981|120|P|   Before using this medication, tell your doctor or pharmacist||
0981|121|P|your medical history, especially of: dehydration, high/low levels||
0981|122|P|of certain minerals in the blood (such as potassium, calcium,||
0981|123|P|sodium, phosphate), kidney disease, current stomach/abdominal||
0981|124|P|symptoms (such as nausea/vomiting that doesn't stop, pain,||
0981|125|P|cramping), bowel problems (such as blockage, ulcerative colitis,||
0981|126|P|hemorrhoids), laxative use for constipation in the past week,||
0981|127|P|heart disease (such as heart failure, chest pain, irregular||
0981|128|P|heartbeat, edema), liver disease, sodium-restricted diet.||
0981|129|P|   Consult your doctor before using this product if you have had||
0981|130|P|a sudden change in bowel habits lasting more than 2 weeks or if||
0981|131|P|you need to use a laxative daily for more than 1 week. These||
0981|132|P|could be symptoms of a serious medical problem.||
0981|133|P|   Before having surgery, tell your doctor or dentist about all||
0981|134|P|the products you use (including prescription drugs,||
0981|135|P|nonprescription drugs, and herbal products).||
0981|136|P|   Young children may be more sensitive to the side effects of||
0981|137|P|this drug, especially dehydration and kidney problems.||
0981|138|P|   Older adults may be more sensitive to the side effects of this||
0981|139|P|drug, especially dehydration and kidney problems.||
0981|140|P|   During pregnancy, this medication should be used only when||
0981|141|P|clearly needed. Discuss the risks and benefits with your doctor.||
0981|142|P|   It is unknown if this drug passes into breast milk. Consult||
0981|143|P|your doctor before breastfeeding.||
0981|144|B|||
0981|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0981|146|I|medications work or increase your risk for serious side effects.||
0981|147|I|This document does not contain all possible drug interactions.||
0981|148|I|Keep a list of all the products you use (including||
0981|149|I|prescription/nonprescription drugs and herbal products) and share||
0981|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
0981|151|I|the dosage of any medicines without your doctor's approval.||
0981|152|I|   Some products that may interact with this drug include:||
0981|153|I|burosumab, other drugs that may affect the kidneys (for example,||
0981|154|I|ACE inhibitors such as lisinopril, ARBs such as valsartan,||
0981|155|I|diuretics/"water pills" such as furosemide/hydrochlorothiazide,||
0981|156|I|NSAIDs such as ibuprofen/naproxen).||
0981|157|I|   The watery bowel movements from sodium phosphate may cause||
0981|158|I|your body to absorb less of your regular medicines and get less||
0981|159|I|benefit from them. Consult your doctor or pharmacist about how to||
0981|160|I|reduce this effect.||
0981|161|B|||
0981|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0981|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0981|164|O|poison control center right away. US residents can call||
0981|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0981|166|O|Symptoms of overdose may include: muscle weakness,||
0981|167|O|fast/slow/irregular heartbeat, mental/mood changes (such as||
0981|168|O|confusion).||
0981|169|B|||
0981|170|N|NOTES:  Lab and/or medical tests (such as kidney function, blood||
0981|171|N|mineral levels) may be done while you are taking this medication.||
0981|172|N|Keep all medical and lab appointments. Consult your doctor for||
0981|173|N|more details.||
0981|174|N|   To maintain normal bowel habits, it is important to drink||
0981|175|N|plenty of fluids (four to six 8-ounce glasses daily), eat foods||
0981|176|N|high in fiber, and exercise regularly.||
0981|177|B|||
0981|178|D|MISSED DOSE:  Not applicable.||
0981|179|B|||
0981|180|R|STORAGE:  Refer to storage information on the package label. If||
0981|181|R|you have any questions about storage, ask your pharmacist. Do not||
0981|182|R|freeze. Keep all drug products away from children and pets.||
0981|183|R|   Do not flush medications down the toilet or pour them into a||
0981|184|R|drain unless instructed to do so. Properly discard this product||
0981|185|R|when it is expired or no longer needed. Consult your pharmacist||
0981|186|R|or local waste disposal company.||
0981|187|B|||
0981|188|A|Information last revised October 2024.||
0981|189|A|Copyright(c) 2025 First Databank, Inc.||
0981|190|B|||
0982|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0982|002|Z|does NOT have all possible information about this product. This||
0982|003|Z|information does not assure that this product is safe, effective,||
0982|004|Z|or appropriate for you. This information is not individual||
0982|005|Z|medical advice and does not substitute for the advice of your||
0982|006|Z|health care professional. Always ask your health care||
0982|007|Z|professional for complete information about this product and your||
0982|008|Z|specific health needs.||
0982|009|B|||
0982|010|T|TOCILIZUMAB - INJECTION||
0982|011|F|(TOE-si-LIZ-oo-mab)||
0982|012|B|||
0982|013|C|COMMON BRAND NAME(S): Actemra, Avtozma, Tofidence, Tyenne||
0982|014|B|||
0982|015|W|WARNING:  This medication may lower your ability to fight an||
0982|016|W|infection. This may make you more likely to get a serious (rarely||
0982|017|W|fatal) infection or make any infection you have worse. Your risk||
0982|018|W|may be increased if you are also taking other drugs that can||
0982|019|W|lower your ability to fight an infection (such as methotrexate or||
0982|020|W|corticosteroids). Before using tocilizumab, tell your doctor your||
0982|021|W|medical history, especially of any kind of infection. During||
0982|022|W|treatment, get medical help right away if you have any signs of||
0982|023|W|infection (such as sore throat that doesn't go away, fever,||
0982|024|W|swollen lymph nodes, chills, pain when urinating).||
0982|025|W|   Before starting this medication, your doctor should test you||
0982|026|W|for tuberculosis (TB), except if you are using this medication to||
0982|027|W|treat COVID-19. Your doctor should monitor you for symptoms of TB||
0982|028|W|during treatment with this drug. If needed, treatment for||
0982|029|W|tuberculosis or other infections should be given before receiving||
0982|030|W|this medication.||
0982|031|B|||
0982|032|U|USES:  This medication is used to treat rheumatoid arthritis in||
0982|033|U|adults and in children (such as systemic juvenile idiopathic||
0982|034|U|arthritis-SJIA, polyarticular juvenile idiopathic||
0982|035|U|arthritis-PJIA). It helps to reduce pain and swelling due to||
0982|036|U|rheumatoid arthritis. Tocilizumab can also be used to treat giant||
0982|037|U|cell arteritis. It helps to reduce swelling in your blood vessels||
0982|038|U|so blood can flow more easily. Tocilizumab may be used to treat a||
0982|039|U|reaction (Cytokine Release Syndrome-CRS) caused by certain cancer||
0982|040|U|treatments. Tocilizumab is also used in combination with a||
0982|041|U|corticosteroid (such as dexamethasone) to treat coronavirus||
0982|042|U|disease (COVID-19) in hospitalized patients who need supplemental||
0982|043|U|oxygen (including patients on a mechanical ventilator).||
0982|044|U|Tocilizumab belongs to a class of drugs known as Interleukin-6||
0982|045|U|(IL-6) blockers. It works by blocking IL-6, a substance made by||
0982|046|U|the body that causes swelling (inflammation).||
0982|047|U|   This monograph is about the following tocilizumab products:||
0982|048|U|tocilizumab, tocilizumab-aazg, tocilizumab-anoh, and||
0982|049|U|tocilizumab-bavi.||
0982|050|B|||
0982|051|H|HOW TO USE:  Read the Medication Guide provided by your||
0982|052|H|pharmacist before you start using tocilizumab and each time you||
0982|053|H|get a refill. If you have any questions, ask your doctor or||
0982|054|H|pharmacist.||
0982|055|H|   This medication is given by a health care professional as||
0982|056|H|directed by your doctor. It is given by slow injection into a||
0982|057|H|vein for 60 minutes. For the treatment of rheumatoid arthritis in||
0982|058|H|adults, PJIA, or giant cell arteritis, this medication is usually||
0982|059|H|given every 4 weeks. For the treatment of SJIA, this medication||
0982|060|H|is usually given every 2 weeks. For the treatment of CRS or||
0982|061|H|COVID-19, this medication is given once and then as directed by||
0982|062|H|your doctor if more doses are needed.||
0982|063|H|   The dosage is based on your medical condition, age, weight,||
0982|064|H|lab tests, and response to treatment.||
0982|065|H|   Use this medication regularly to get the most benefit from it.||
0982|066|H|To help you remember, mark your calendar with a reminder.||
0982|067|H|   Tell your doctor if your condition does not get better or if||
0982|068|H|it gets worse.||
0982|069|B|||
0982|070|S|SIDE EFFECTS:  See also Warning section.||
0982|071|S|   Headache or pain/redness/swelling at the injection site may||
0982|072|S|occur. If any of these effects last or get worse, tell your||
0982|073|S|doctor or pharmacist promptly.||
0982|074|S|   Remember that this medication has been prescribed because your||
0982|075|S|doctor has judged that the benefit to you is greater than the||
0982|076|S|risk of side effects. Many people using this medication do not||
0982|077|S|have serious side effects.||
0982|078|S|   Tell your doctor right away if you have any serious side||
0982|079|S|effects, including: signs of stomach/intestinal problems (such as||
0982|080|S|severe stomach/abdominal pain that doesn't go away, changes in||
0982|081|S|bowel movements).||
0982|082|S|   Tocilizumab has rarely caused very serious (possibly fatal)||
0982|083|S|liver disease. This effect may occur months to years after||
0982|084|S|starting this medication. Tell your doctor right away if you||
0982|085|S|develop symptoms of liver disease, such as nausea/vomiting that||
0982|086|S|doesn't stop, loss of appetite, yellowing eyes/skin, dark urine.||
0982|087|S|   A very serious allergic reaction to this drug is rare.||
0982|088|S|However, get medical help right away if you notice any symptoms||
0982|089|S|of a serious allergic reaction, including: rash, itching/swelling||
0982|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0982|091|S|breathing.||
0982|092|S|   This is not a complete list of possible side effects. If you||
0982|093|S|notice other effects not listed above, contact your doctor or||
0982|094|S|pharmacist.||
0982|095|S|   In the US -||
0982|096|S|   Call your doctor for medical advice about side effects. You||
0982|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0982|098|S|www.fda.gov/medwatch.||
0982|099|S|   In Canada - Call your doctor for medical advice about side||
0982|100|S|effects. You may report side effects to Health Canada at||
0982|101|S|1-866-234-2345.||
0982|102|B|||
0982|103|P|PRECAUTIONS:  Before receiving tocilizumab, tell your doctor or||
0982|104|P|pharmacist if you are allergic to it; or to any tocilizumab||
0982|105|P|products; or if you have any other allergies. This product may||
0982|106|P|contain inactive ingredients, which can cause allergic reactions||
0982|107|P|or other problems. Talk to your pharmacist for more details.||
0982|108|P|   Before using this medication, tell your doctor or pharmacist||
0982|109|P|your medical history, especially of: diabetes, immune system||
0982|110|P|problems, infections (including past/current/returning), liver||
0982|111|P|problems, low blood cell count, nervous system problems (such as||
0982|112|P|multiple sclerosis), stomach/abdominal problems (such as ulcers,||
0982|113|P|diverticulitis).||
0982|114|P|   Tocilizumab can make you more likely to get infections or may||
0982|115|P|make current infections worse. Stay away from anyone who has an||
0982|116|P|infection that may easily spread (such as chickenpox, COVID-19,||
0982|117|P|measles, tuberculosis, flu). Tell your doctor if you live in,||
0982|118|P|have lived in, or have traveled to certain areas where there is||
0982|119|P|an increased chance of getting certain kinds of fungal infections||
0982|120|P|(blastomycosis, coccidioidomycosis, histoplasmosis). Talk to your||
0982|121|P|doctor if you have been exposed to an infection or for more||
0982|122|P|details.||
0982|123|P|   Tell your health care professional that you are using||
0982|124|P|tocilizumab before having any immunizations/vaccinations. Avoid||
0982|125|P|contact with people who have recently received live vaccines||
0982|126|P|(such as flu vaccine inhaled through the nose).||
0982|127|P|   Drugs that affect the immune system (such as tocilizumab) may||
0982|128|P|increase your risk of certain cancers. Tell your doctor if you||
0982|129|P|have ever had any type of cancer.||
0982|130|P|   Before having surgery, tell your doctor or dentist about all||
0982|131|P|the products you use (including prescription drugs,||
0982|132|P|nonprescription drugs, and herbal products).||
0982|133|P|   During pregnancy, this medication should be used only when||
0982|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
0982|135|P|   It is unknown if this drug passes into breast milk and the||
0982|136|P|effect on a nursing infant is unknown. Consult your doctor before||
0982|137|P|breastfeeding.||
0982|138|B|||
0982|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0982|140|I|medications work or increase your risk for serious side effects.||
0982|141|I|This document does not contain all possible drug interactions.||
0982|142|I|Keep a list of all the products you use (including||
0982|143|I|prescription/nonprescription drugs and herbal products) and share||
0982|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
0982|145|I|the dosage of any medicines without your doctor's approval.||
0982|146|I|   Some products that may interact with this drug include: other||
0982|147|I|drugs that can affect the immune system (such as certolizumab).||
0982|148|I|   This medication can speed up the removal of other medications||
0982|149|I|from your body, which may affect how they work. Examples of||
0982|150|I|affected drugs include some cholesterol drugs such as||
0982|151|I|atorvastatin/lovastatin/simvastatin, omeprazole, warfarin, among||
0982|152|I|others.||
0982|153|I|   This medication may decrease the effectiveness of hormonal||
0982|154|I|birth control such as pills, patch, or ring. This could cause||
0982|155|I|pregnancy. Discuss with your doctor or pharmacist if you should||
0982|156|I|use reliable backup birth control methods while using this||
0982|157|I|medication. Also tell your doctor if you have any new spotting or||
0982|158|I|breakthrough bleeding, because these may be signs that your birth||
0982|159|I|control is not working well.||
0982|160|B|||
0982|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0982|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0982|163|O|poison control center right away. US residents can call||
0982|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0982|165|B|||
0982|166|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
0982|167|N|liver function, cholesterol tests) should be done before you||
0982|168|N|start using this medication and while you are using it. Keep all||
0982|169|N|medical and lab appointments. Consult your doctor for more||
0982|170|N|details.||
0982|171|B|||
0982|172|D|MISSED DOSE:  It is important to get each dose of this medication||
0982|173|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0982|174|D|right away for a new dosing schedule.||
0982|175|B|||
0982|176|R|STORAGE:  Not applicable. This medication is given in a clinic||
0982|177|R|and will not be stored at home.||
0982|178|B|||
0982|179|A|Information last revised September 2025.||
0982|180|A|Copyright(c) 2025 First Databank, Inc.||
0982|181|B|||
0983|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0983|002|Z|does NOT have all possible information about this product. This||
0983|003|Z|information does not assure that this product is safe, effective,||
0983|004|Z|or appropriate for you. This information is not individual||
0983|005|Z|medical advice and does not substitute for the advice of your||
0983|006|Z|health care professional. Always ask your health care||
0983|007|Z|professional for complete information about this product and your||
0983|008|Z|specific health needs.||
0983|009|B|||
0983|010|T|RIVASTIGMINE PATCH - TRANSDERMAL||
0983|011|F|(riv-uh-STIG-meen)||
0983|012|B|||
0983|013|C|COMMON BRAND NAME(S): Exelon||
0983|014|B|||
0983|015|U|USES:  Rivastigmine is used to treat confusion (dementia) related||
0983|016|U|to Alzheimer's disease and to Parkinson's disease. Rivastigmine||
0983|017|U|does not cure either of these diseases, but it may improve||
0983|018|U|memory, awareness, and the ability to perform daily functions.||
0983|019|U|This medication works by restoring the balance of natural||
0983|020|U|substances (neurotransmitters) in the brain.||
0983|021|B|||
0983|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0983|023|H|from your pharmacist before you start using this medication and||
0983|024|H|each time you get a refill. Follow all instructions for how to||
0983|025|H|properly apply and use the patches. If you have any questions,||
0983|026|H|consult your doctor or pharmacist.||
0983|027|H|   Apply the patch to the skin as directed by your doctor,||
0983|028|H|usually once daily. Do not open the sealed pouch until ready to||
0983|029|H|use. Open the pouch and remove the patch from the protective||
0983|030|H|liner. Do not cut the patch. Apply the patch as directed to a||
0983|031|H|clean, dry, hairless area on the back, upper arm, or chest.||
0983|032|H|Remove the old patch first before applying a new patch. Do not||
0983|033|H|wear 2 patches at the same time. Do not apply the patch to||
0983|034|H|red/irritated/broken areas of skin or to areas where you have||
0983|035|H|applied creams or lotions. Avoid applying it to areas where tight||
0983|036|H|clothing may rub the patch off. You can bathe with the patch on.||
0983|037|H|   When changing your patch, remove the old patch, fold it in||
0983|038|H|half with the sticky sides together, and throw it away out of||
0983|039|H|reach of children and pets. Apply a new patch to a different area||
0983|040|H|to prevent skin irritation. Do not apply a new patch to the same||
0983|041|H|area for at least 2 weeks.||
0983|042|H|   If the patch falls off before it is due to be changed, apply a||
0983|043|H|new patch right away and replace the new patch at the regularly||
0983|044|H|scheduled time the next day. Do not try to reapply the old patch||
0983|045|H|or use tape to keep a loose patch from falling off.||
0983|046|H|   Do not touch your eyes while you are handling the patch. Wash||
0983|047|H|your hands with soap and water after each application. If the||
0983|048|H|medication comes in contact with your eyes or if your eyes become||
0983|049|H|red after handling the patch, rinse your eyes right away with||
0983|050|H|water. Tell your doctor if the redness or other symptoms do not||
0983|051|H|go away.||
0983|052|H|   Dosage is based on your medical condition and response to||
0983|053|H|treatment. To reduce your risk of side effects (such as nausea||
0983|054|H|and diarrhea), your doctor will start this medication using a||
0983|055|H|lower dose of the patch and may increase your dose after 4 weeks.||
0983|056|H|Follow your doctor's instructions carefully. Do not increase your||
0983|057|H|dose or use this drug more often than prescribed. Do not apply||
0983|058|H|more than one patch per day or leave the patch on for longer than||
0983|059|H|prescribed. Your condition will not improve any faster, and your||
0983|060|H|risk of side effects will increase.||
0983|061|H|   Use this medication regularly to get the most benefit from it.||
0983|062|H|To help you remember, change your patch at the same time each||
0983|063|H|day.||
0983|064|H|   If you do not use rivastigmine for 3 or more days in row, talk||
0983|065|H|with your doctor before starting again. You may need to restart||
0983|066|H|at a lower dose.||
0983|067|H|   Tell your doctor if your condition gets worse.||
0983|068|B|||
0983|069|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite/weight loss,||
0983|070|S|diarrhea, weakness, dizziness, drowsiness, shakiness (tremors),||
0983|071|S|and skin irritation at the application site may occur. If any of||
0983|072|S|these effects last or get worse, contact your doctor or||
0983|073|S|pharmacist promptly.||
0983|074|S|   Remember that this medication has been prescribed because your||
0983|075|S|doctor has judged that the benefit to you is greater than the||
0983|076|S|risk of side effects. Many people using this medication do not||
0983|077|S|have serious side effects.||
0983|078|S|   Tell your doctor right away if any of these serious side||
0983|079|S|effects occur: slow heartbeat, black stools, vomit that looks||
0983|080|S|like coffee grounds, severe stomach/abdominal pain, seizures,||
0983|081|S|trouble urinating.||
0983|082|S|   Get medical help right away if you have any very serious side||
0983|083|S|effects, including: fast/irregular heartbeat, severe dizziness,||
0983|084|S|fainting.||
0983|085|S|   A very serious allergic reaction to this drug is rare.||
0983|086|S|However, get medical help right away if you notice any symptoms||
0983|087|S|of a serious allergic reaction, including: rash, itching/swelling||
0983|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0983|089|S|breathing.||
0983|090|S|   This is not a complete list of possible side effects. If you||
0983|091|S|notice other effects not listed above, contact your doctor or||
0983|092|S|pharmacist.||
0983|093|S|   In the US -||
0983|094|S|   Call your doctor for medical advice about side effects. You||
0983|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0983|096|S|www.fda.gov/medwatch.||
0983|097|S|   In Canada - Call your doctor for medical advice about side||
0983|098|S|effects. You may report side effects to Health Canada at||
0983|099|S|1-866-234-2345.||
0983|100|B|||
0983|101|P|PRECAUTIONS:  Before using rivastigmine, tell your doctor or||
0983|102|P|pharmacist if you are allergic to it (including any serious||
0983|103|P|allergic skin reaction with past use of the patch); or if you||
0983|104|P|have any other allergies. This product may contain inactive||
0983|105|P|ingredients, which can cause allergic reactions or other||
0983|106|P|problems. Talk to your pharmacist for more details.||
0983|107|P|   Before using this medication, tell your doctor or pharmacist||
0983|108|P|your medical history, especially of: breathing/lung problems||
0983|109|P|(such as asthma, COPD-chronic obstructive pulmonary disease),||
0983|110|P|stomach/intestinal problems (such as ulcers, bleeding), heart||
0983|111|P|problems (such as sick sinus syndrome, other conduction||
0983|112|P|disorders), fainting, seizures, problems urinating (such as due||
0983|113|P|to enlarged prostate), liver disease.||
0983|114|P|   Rivastigmine may cause a condition that affects the heart||
0983|115|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0983|116|P|serious (rarely fatal) fast/irregular heartbeat and other||
0983|117|P|symptoms (such as severe dizziness, fainting) that need medical||
0983|118|P|attention right away.||
0983|119|P|   The risk of QT prolongation may be increased if you have||
0983|120|P|certain medical conditions or are taking other drugs that may||
0983|121|P|cause QT prolongation. Before using rivastigmine, tell your||
0983|122|P|doctor or pharmacist of all the drugs you take and if you have||
0983|123|P|any of the following conditions: certain heart problems (heart||
0983|124|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0983|125|P|history of certain heart problems (QT prolongation in the EKG,||
0983|126|P|sudden cardiac death).||
0983|127|P|   Low levels of potassium or magnesium in the blood may also||
0983|128|P|increase your risk of QT prolongation. This risk may increase if||
0983|129|P|you use certain drugs (such as diuretics/"water pills") or if you||
0983|130|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0983|131|P|Talk to your doctor about using rivastigmine safely.||
0983|132|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0983|133|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0983|134|P|machinery, or do anything that needs alertness until you can do||
0983|135|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
0983|136|P|are using marijuana (cannabis).||
0983|137|P|   While wearing your patch, avoid exposing it to direct heat||
0983|138|P|(such as prolonged direct sunlight, heating pads, electric||
0983|139|P|blankets, heat lamps, saunas, hot tubs). Heat may cause more drug||
0983|140|P|to be released into your body, increasing the chance of side||
0983|141|P|effects.||
0983|142|P|   If you are going to have an MRI test, tell testing personnel||
0983|143|P|that you are using this patch. Some patches may contain metals||
0983|144|P|that can cause serious burns during an MRI. Ask your doctor||
0983|145|P|whether you will need to remove your patch before the test and||
0983|146|P|apply a new patch afterward, and how to do so properly.||
0983|147|P|   Before having surgery, tell your doctor or dentist about all||
0983|148|P|the products you use (including prescription drugs,||
0983|149|P|nonprescription drugs, and herbal products).||
0983|150|P|   Older adults may be more sensitive to the side effects of this||
0983|151|P|drug, especially QT prolongation (see above).||
0983|152|P|   During pregnancy, this medication should be used only when||
0983|153|P|clearly needed. Discuss the risks and benefits with your doctor.||
0983|154|P|   It is unknown if this medication passes into breast milk.||
0983|155|P|Consult your doctor before breastfeeding.||
0983|156|B|||
0983|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0983|158|I|medications work or increase your risk for serious side effects.||
0983|159|I|This document does not contain all possible drug interactions.||
0983|160|I|Keep a list of all the products you use (including||
0983|161|I|prescription/nonprescription drugs and herbal products) and share||
0983|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
0983|163|I|the dosage of any medicines without your doctor's approval.||
0983|164|I|   Some products that may interact with this drug include:||
0983|165|I|aspirin/nonsteroidal anti-inflammatory drugs (NSAIDs, such as||
0983|166|I|ibuprofen, naproxen), metoclopramide.||
0983|167|I|   Check all prescription and nonprescription medicine labels||
0983|168|I|carefully since many medications contain pain relievers/fever||
0983|169|I|reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that if||
0983|170|I|taken together with rivastigmine may increase your risk for||
0983|171|I|stomach/intestinal bleeding. However, if your doctor has told you||
0983|172|I|to take low-dose aspirin to prevent heart attack or stroke||
0983|173|I|(usually 81-162 milligrams a day), you should keep taking the||
0983|174|I|aspirin unless your doctor tells you not to. Ask your doctor or||
0983|175|I|pharmacist for more details.||
0983|176|B|||
0983|177|O|OVERDOSE:  This medication patch may be harmful if chewed or||
0983|178|O|swallowed. If someone has overdosed, remove the patch if||
0983|179|O|possible. For serious symptoms such as passing out or trouble||
0983|180|O|breathing, call 911. Otherwise, call a poison control center||
0983|181|O|right away. US residents can call 1-800-222-1222. Canada||
0983|182|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0983|183|O|include: nausea/vomiting that is severe or doesn't stop,||
0983|184|O|excessive sweating, very slow heartbeat, slow or shallow||
0983|185|O|breathing, seizure.||
0983|186|B|||
0983|187|N|NOTES:  Do not share this medication with others.||
0983|188|N|   Lab and/or medical tests (such as weight) should be done while||
0983|189|N|you are using this medication. Keep all medical and lab||
0983|190|N|appointments. Consult your doctor for more details.||
0983|191|B|||
0983|192|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0983|193|D|Replace the new patch at the regularly scheduled time the next||
0983|194|D|day. Do not use 2 patches to catch up.||
0983|195|B|||
0983|196|R|STORAGE:  Store at room temperature. Keep all medications away||
0983|197|R|from children and pets.||
0983|198|R|   Do not flush medications down the toilet or pour them into a||
0983|199|R|drain unless instructed to do so. Properly discard this product||
0983|200|R|when it is expired or no longer needed. Consult your pharmacist||
0983|201|R|or local waste disposal company.||
0983|202|B|||
0983|203|A|Information last revised February 2025.||
0983|204|A|Copyright(c) 2025 First Databank, Inc.||
0983|205|B|||
0984|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0984|002|Z|does NOT have all possible information about this product. This||
0984|003|Z|information does not assure that this product is safe, effective,||
0984|004|Z|or appropriate for you. This information is not individual||
0984|005|Z|medical advice and does not substitute for the advice of your||
0984|006|Z|health care professional. Always ask your health care||
0984|007|Z|professional for complete information about this product and your||
0984|008|Z|specific health needs.||
0984|009|B|||
0984|010|T|STREPTOMYCIN - INJECTION||
0984|011|F|(strep-toe-MYE-sin)||
0984|012|B|||
0984|013|W|WARNING:  This medication can sometimes cause serious nerve||
0984|014|W|damage, possibly resulting in permanent hearing loss and balance||
0984|015|W|problems. The risk is higher if you have kidney disease, if you||
0984|016|W|are receiving high doses of this medication, if you use this drug||
0984|017|W|for a long time, if you are an older adult (older than 60 years),||
0984|018|W|or if you develop a severe loss of body water (become||
0984|019|W|dehydrated). To reduce the risk of dehydration, drink plenty of||
0984|020|W|fluids while using this medication unless your doctor directs you||
0984|021|W|otherwise. Before starting streptomycin, tell your doctor if you||
0984|022|W|already have kidney or hearing problems.||
0984|023|W|   Tell your doctor right away if you notice ringing/roaring in||
0984|024|W|the ears, headache, hearing loss, balance problems, unusual||
0984|025|W|drowsiness, dizziness, vision changes, or numbness/tingling of||
0984|026|W|the skin.||
0984|027|W|   Your doctor will monitor your progress to reduce the risk of||
0984|028|W|these side effects and may test your hearing, kidneys, and||
0984|029|W|streptomycin blood level. This medication may be stopped if you||
0984|030|W|develop kidney problems or hearing problems.||
0984|031|W|   If possible, you should avoid using any other medications that||
0984|032|W|may harm the kidneys or nerves while using streptomycin (such as||
0984|033|W|cidofovir, cisplatin, cyclosporine, other aminoglycoside||
0984|034|W|antibiotics such as gentamicin/tobramycin, among others).||
0984|035|W|   Before having surgery, tell your doctor or dentist that you||
0984|036|W|are using this medication. This drug may affect many of the drugs||
0984|037|W|used during surgery and may increase your risk of side effects.||
0984|038|B|||
0984|039|U|USES:  This medication is used with other medications to treat||
0984|040|U|active tuberculosis (TB) infection if you cannot take other drugs||
0984|041|U|for TB or if you have a type of TB that cannot be treated with||
0984|042|U|other drugs (drug-resistant TB). Streptomycin belongs to a class||
0984|043|U|of drugs known as aminoglycoside antibiotics. It works by killing||
0984|044|U|the organisms that cause the infection.||
0984|045|U|   This drug may also be used to treat other serious infections||
0984|046|U|(such as Mycobacterium avium complex-MAC, tularemia,||
0984|047|U|endocarditis, plague) along with other medications.||
0984|048|B|||
0984|049|H|HOW TO USE:  This medication is given by injection into a muscle||
0984|050|H|as directed by your doctor. The dosage is based on your medical||
0984|051|H|condition, weight, streptomycin blood levels, and response to||
0984|052|H|treatment.||
0984|053|H|   When you start treatment for TB, this medication is usually||
0984|054|H|given once a day or as directed by your doctor. Medication to||
0984|055|H|treat tuberculosis is usually used for 9 months or longer. After||
0984|056|H|you receive streptomycin daily for 1 to 2 months, your doctor may||
0984|057|H|direct you to receive this medication less often (such as 2 to 3||
0984|058|H|times a week). Your doctor may direct you to stop using this||
0984|059|H|medication before stopping your other TB medications. It is very||
0984|060|H|important to keep using streptomycin and your other medications||
0984|061|H|exactly as prescribed by your doctor.||
0984|062|H|   If you are giving this medication to yourself at home, learn||
0984|063|H|all preparation and usage instructions from your health care||
0984|064|H|professional. Before using, check this product for particles or||
0984|065|H|discoloration. If either is present, do not use the liquid.||
0984|066|H|Before injecting each dose, clean the skin you are going to||
0984|067|H|inject into (the injection site) with rubbing alcohol. Change the||
0984|068|H|injection site each time to lessen injury under the skin. Learn||
0984|069|H|how to store and discard medical supplies safely.||
0984|070|H|   Do not stop taking this medication (or other TB||
0984|071|H|medicines/antibiotics) even for a short time unless directed to||
0984|072|H|do so by your doctor. Skipping or changing your dose without||
0984|073|H|approval from your doctor may worsen side effects or make the||
0984|074|H|infection (especially TB) more difficult to treat (resistant). If||
0984|075|H|TB becomes resistant to this medication, it might also become||
0984|076|H|resistant to other TB medications.||
0984|077|H|   For the best effect, use this antibiotic at evenly spaced||
0984|078|H|times. To help you remember, mark your calendar with a reminder.||
0984|079|H|   Tell your doctor right away if your infection symptoms return||
0984|080|H|(such as fever, chills, body aches) while you are using this||
0984|081|H|medication or after you stop using it.||
0984|082|B|||
0984|083|S|SIDE EFFECTS:  See also Warning section.||
0984|084|S|   Nausea, vomiting, stomach upset, or loss of appetite may||
0984|085|S|occur. Pain/irritation/redness may occur at the injection site.||
0984|086|S|If any of these effects last or get worse, tell your doctor or||
0984|087|S|pharmacist promptly.||
0984|088|S|   Remember that this medication has been prescribed because your||
0984|089|S|doctor has judged that the benefit to you is greater than the||
0984|090|S|risk of side effects. Many people using this medication do not||
0984|091|S|have serious side effects.||
0984|092|S|   Tell your doctor right away if you have any serious side||
0984|093|S|effects, including: muscle weakness, diarrhea that doesn't go||
0984|094|S|away even after stopping this medication, easy bleeding/bruising,||
0984|095|S|fast heartbeat, new signs of infections (such as sore throat that||
0984|096|S|doesn't go away, fever, chills), signs of kidney problems (such||
0984|097|S|as change in the amount of urine), unusual tiredness.||
0984|098|S|   Use of this medication for prolonged or repeated periods may||
0984|099|S|result in oral thrush or a new vaginal yeast infection. Contact||
0984|100|S|your doctor if you notice white patches in your mouth, a change||
0984|101|S|in vaginal discharge, or other new symptoms.||
0984|102|S|   A very serious allergic reaction to this drug is rare.||
0984|103|S|However, get medical help right away if you notice any symptoms||
0984|104|S|of a serious allergic reaction, including: rash, itching/swelling||
0984|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0984|106|S|breathing.||
0984|107|S|   This is not a complete list of possible side effects. If you||
0984|108|S|notice other effects not listed above, contact your doctor or||
0984|109|S|pharmacist.||
0984|110|S|   In the US -||
0984|111|S|   Call your doctor for medical advice about side effects. You||
0984|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0984|113|S|www.fda.gov/medwatch.||
0984|114|S|   In Canada - Call your doctor for medical advice about side||
0984|115|S|effects. You may report side effects to Health Canada at||
0984|116|S|1-866-234-2345.||
0984|117|B|||
0984|118|P|PRECAUTIONS:  See also Warning section.||
0984|119|P|   Before using streptomycin injection, tell your doctor or||
0984|120|P|pharmacist if you are allergic to it; or to other aminoglycoside||
0984|121|P|antibiotics (such as tobramycin, gentamicin); or if you have any||
0984|122|P|other allergies. This product may contain inactive ingredients,||
0984|123|P|which can cause allergic reactions or other problems. Talk to||
0984|124|P|your pharmacist for more details.||
0984|125|P|   Before using this medication, tell your doctor or pharmacist||
0984|126|P|your medical history, especially of: kidney problems, hearing||
0984|127|P|problems, dehydration, a certain muscle problem (myasthenia||
0984|128|P|gravis), burns over a large area of skin, cystic fibrosis.||
0984|129|P|   Streptomycin may cause live bacterial vaccines (such as BCG,||
0984|130|P|typhoid vaccine) to not work well. Tell your health care||
0984|131|P|professional that you are using streptomycin before having any||
0984|132|P|immunizations/vaccinations.||
0984|133|P|   Before having surgery, tell your doctor or dentist about all||
0984|134|P|the products you use (including prescription drugs,||
0984|135|P|nonprescription drugs, and herbal products).||
0984|136|P|   Older adults may be more sensitive to the side effects of this||
0984|137|P|drug, especially kidney and hearing effects.||
0984|138|P|   Tell your doctor if you are pregnant or plan to become||
0984|139|P|pregnant. You should not become pregnant while using||
0984|140|P|streptomycin. Streptomycin may harm an unborn baby. If you become||
0984|141|P|pregnant, talk to your doctor right away about the risks and||
0984|142|P|benefits of this medication.||
0984|143|P|   This medication passes into breast milk. Consult your doctor||
0984|144|P|before breastfeeding.||
0984|145|B|||
0984|146|I|DRUG INTERACTIONS:  See also Warning section.||
0984|147|I|   Drug interactions may change how your medications work or||
0984|148|I|increase your risk for serious side effects. This document does||
0984|149|I|not contain all possible drug interactions. Keep a list of all||
0984|150|I|the products you use (including prescription/nonprescription||
0984|151|I|drugs and herbal products) and share it with your doctor and||
0984|152|I|pharmacist. Do not start, stop, or change the dosage of any||
0984|153|I|medicines without your doctor's approval.||
0984|154|I|   Some products that may interact with this drug include:||
0984|155|I|amphotericin B, high doses of aspirin/NSAIDs such as||
0984|156|I|ibuprofen/naproxen.||
0984|157|I|   If your doctor has directed you to take low doses of aspirin||
0984|158|I|to prevent heart attack or stroke (usually 81-162 milligrams a||
0984|159|I|day), you should continue to take the aspirin. Consult your||
0984|160|I|doctor or pharmacist for more details.||
0984|161|B|||
0984|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0984|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0984|164|O|poison control center right away. US residents can call||
0984|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0984|166|O|Symptoms may include: extreme drowsiness, slow/shallow breathing,||
0984|167|O|inability to move.||
0984|168|B|||
0984|169|N|NOTES:  Lab and/or medical tests (such as kidney function,||
0984|170|N|hearing tests, streptomycin levels) should be done while you are||
0984|171|N|using this medication. Keep all medical and lab appointments.||
0984|172|N|Consult your doctor for more details.||
0984|173|B|||
0984|174|D|MISSED DOSE:  It is important to get each dose of this medication||
0984|175|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
0984|176|D|right away for a new dosing schedule.||
0984|177|B|||
0984|178|R|STORAGE:  Store unmixed medication at room temperature away from||
0984|179|R|light. Keep all medications away from children and pets.||
0984|180|R|   Do not flush medications down the toilet or pour them into a||
0984|181|R|drain unless instructed to do so. Properly discard this product||
0984|182|R|when it is expired or no longer needed. Consult your pharmacist||
0984|183|R|or local waste disposal company.||
0984|184|B|||
0984|185|A|Information last revised April 2025.||
0984|186|A|Copyright(c) 2025 First Databank, Inc.||
0984|187|B|||
0985|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0985|002|Z|does NOT have all possible information about this product. This||
0985|003|Z|information does not assure that this product is safe, effective,||
0985|004|Z|or appropriate for you. This information is not individual||
0985|005|Z|medical advice and does not substitute for the advice of your||
0985|006|Z|health care professional. Always ask your health care||
0985|007|Z|professional for complete information about this product and your||
0985|008|Z|specific health needs.||
0985|009|B|||
0985|010|T|PHENYLEPHRINE HEMORRHOIDAL GEL - TOPICAL||
0985|011|F|(FEN-il-EF-rin)||
0985|012|B|||
0985|013|C|COMMON BRAND NAME(S): Preparation H||
0985|014|B|||
0985|015|U|USES:  This medication is used to temporarily relieve swelling,||
0985|016|U|burning, pain, and itching caused by hemorrhoids. It contains||
0985|017|U|phenylephrine, which belongs to a class of drugs known as||
0985|018|U|sympathomimetic amines. It works by temporarily narrowing the||
0985|019|U|blood vessels in the area. This effect decreases swelling and||
0985|020|U|discomfort.||
0985|021|U|   Some products may also contain substances (such as cocoa||
0985|022|U|butter, hard fat, mineral oil, shark liver oil) that soothe or||
0985|023|U|form a protective barrier to prevent too much irritating contact||
0985|024|U|with stool.||
0985|025|U|   Do not use this product in children 12 years or younger||
0985|026|U|without talking with the doctor.||
0985|027|B|||
0985|028|H|HOW TO USE:  Follow all directions on the product package. If you||
0985|029|H|have any questions, ask your doctor or pharmacist. Before use,||
0985|030|H|clean the area with mild soap and water, rinse well, and pat dry.||
0985|031|H|   Apply the product to the skin of the affected area up to 4||
0985|032|H|times daily, usually in the morning and bedtime, or after each||
0985|033|H|bowel movement, or as directed by your doctor. Do not apply the||
0985|034|H|product inside the rectum.||
0985|035|H|   Dosage is based on your medical condition and response to||
0985|036|H|treatment. Do not use more often or for a longer time than||
0985|037|H|recommended.||
0985|038|H|   Tell your doctor if your symptoms do not get better within 7||
0985|039|H|days or if bleeding/worsening pain occurs. If you think you may||
0985|040|H|have a serious medical problem, get medical help right away.||
0985|041|B|||
0985|042|S|SIDE EFFECTS:  This medication does not usually have bothersome||
0985|043|S|side effects when used as directed. Mild pain/stinging may occur.||
0985|044|S|If any of these effects last or get worse, tell your doctor or||
0985|045|S|pharmacist promptly.||
0985|046|S|   If your doctor has directed you to use this medication,||
0985|047|S|remember that your doctor has judged that the benefit to you is||
0985|048|S|greater than the risk of side effects. Many people using this||
0985|049|S|medication do not have serious side effects.||
0985|050|S|   Stop using this medication and tell your doctor right away if||
0985|051|S|you have any serious side effects, including: fast/irregular||
0985|052|S|heartbeat, pounding headache, nervousness, shakiness (tremor),||
0985|053|S|trouble sleeping.||
0985|054|S|   A very serious allergic reaction to this drug is rare.||
0985|055|S|However, get medical help right away if you notice any symptoms||
0985|056|S|of a serious allergic reaction, including: rash, itching/swelling||
0985|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0985|058|S|breathing.||
0985|059|S|   This is not a complete list of possible side effects. If you||
0985|060|S|notice other effects not listed above, contact your doctor or||
0985|061|S|pharmacist.||
0985|062|S|   In the US -||
0985|063|S|   Call your doctor for medical advice about side effects. You||
0985|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0985|065|S|www.fda.gov/medwatch.||
0985|066|S|   In Canada - Call your doctor for medical advice about side||
0985|067|S|effects. You may report side effects to Health Canada at||
0985|068|S|1-866-234-2345.||
0985|069|B|||
0985|070|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0985|071|P|pharmacist if you are allergic to it; or to any of its||
0985|072|P|ingredients; or if you have any other allergies. This product may||
0985|073|P|contain inactive ingredients, which can cause allergic reactions||
0985|074|P|or other problems. Talk to your pharmacist for more details.||
0985|075|P|   If you have any of the following health problems, consult your||
0985|076|P|doctor or pharmacist before using this product: diabetes, heart||
0985|077|P|problems (such as chest pain, heart attack), high blood pressure,||
0985|078|P|overactive thyroid (hyperthyroidism), difficult urination due to||
0985|079|P|blockage (such as due to enlarged prostate).||
0985|080|P|   Before having surgery, tell your doctor or dentist about all||
0985|081|P|the products you use (including prescription drugs,||
0985|082|P|nonprescription drugs, and herbal products).||
0985|083|P|   During pregnancy, this medication should be used only when||
0985|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
0985|085|P|   It is unknown if this drug passes into breast milk. Consult||
0985|086|P|your doctor before breastfeeding.||
0985|087|B|||
0985|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0985|089|I|medications work or increase your risk for serious side effects.||
0985|090|I|This document does not contain all possible drug interactions.||
0985|091|I|Keep a list of all the products you use (including||
0985|092|I|prescription/nonprescription drugs and herbal products) and share||
0985|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
0985|094|I|the dosage of any medicines without your doctor's approval.||
0985|095|I|   Some products that may interact with this drug are: MAO||
0985|096|I|inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue,||
0985|097|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0985|098|I|selegiline, tranylcypromine).||
0985|099|B|||
0985|100|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0985|101|O|has overdosed and has serious symptoms such as passing out or||
0985|102|O|trouble breathing, call 911. Otherwise, call a poison control||
0985|103|O|center right away. US residents can call 1-800-222-1222. Canada||
0985|104|O|residents can call 1-844-764-7669.||
0985|105|B|||
0985|106|N|NOTES:  To maintain normal bowel function and reduce the risk of||
0985|107|N|hemorrhoids, eat a proper diet high in fiber, drink 6 to 8||
0985|108|N|glasses of water each day, and exercise regularly.||
0985|109|B|||
0985|110|D|MISSED DOSE:  If you are using this product on a regular schedule||
0985|111|D|and miss a dose, use it as soon as you remember. If it is near||
0985|112|D|the time of the next dose, skip the missed dose. Use your next||
0985|113|D|dose at the regular time. Do not double the dose to catch up.||
0985|114|B|||
0985|115|R|STORAGE:  Store at room temperature. Different brands of this||
0985|116|R|medication may have different storage needs. Check the product||
0985|117|R|package for instructions on how to store your brand, or ask your||
0985|118|R|pharmacist. Keep all medications away from children and pets.||
0985|119|R|   Do not flush medications down the toilet or pour them into a||
0985|120|R|drain unless instructed to do so. Properly discard this product||
0985|121|R|when it is expired or no longer needed. Consult your pharmacist||
0985|122|R|or local waste disposal company.||
0985|123|B|||
0985|124|A|Information last revised November 2024.||
0985|125|A|Copyright(c) 2025 First Databank, Inc.||
0985|126|B|||
0986|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0986|002|Z|does NOT have all possible information about this product. This||
0986|003|Z|information does not assure that this product is safe, effective,||
0986|004|Z|or appropriate for you. This information is not individual||
0986|005|Z|medical advice and does not substitute for the advice of your||
0986|006|Z|health care professional. Always ask your health care||
0986|007|Z|professional for complete information about this product and your||
0986|008|Z|specific health needs.||
0986|009|B|||
0986|010|T|HYDROGEN PEROXIDE LIQUID - TOPICAL||
0986|011|F|(HYE-droe-jen per-OX-ide)||
0986|012|B|||
0986|013|U|USES:  Hydrogen peroxide is a mild antiseptic used on the skin to||
0986|014|U|prevent infection of minor cuts, scrapes, and burns. It may also||
0986|015|U|be used as a mouth rinse to help remove mucus or to relieve minor||
0986|016|U|mouth irritation (such as due to canker/cold sores, gingivitis).||
0986|017|U|This product works by releasing oxygen when it is applied to the||
0986|018|U|affected area. The release of oxygen causes foaming, which helps||
0986|019|U|to remove dead skin and clean the area.||
0986|020|U|   This product should not be used to treat deep wounds, animal||
0986|021|U|bites, or serious burns.||
0986|022|B|||
0986|023|H|HOW TO USE:  Follow all directions on the product package. If you||
0986|024|H|have any questions, ask your doctor or pharmacist.||
0986|025|H|   Do not use in the eyes or apply over large areas of skin.||
0986|026|H|   If you are using this product on the skin, clean the affected||
0986|027|H|area before use. Apply a small amount of product on the affected||
0986|028|H|area, usually 1 to 3 times daily or as directed by your doctor.||
0986|029|H|If you apply a bandage after using this product, let the area dry||
0986|030|H|first.||
0986|031|H|   If you are using this product as a mouth rinse, mix with an||
0986|032|H|equal amount of water before using. Swish in the mouth over the||
0986|033|H|affected area for at least 1 minute, then spit out. Do not||
0986|034|H|swallow this product. Rinse up to 4 times daily or as directed by||
0986|035|H|your dentist or doctor.||
0986|036|H|   Use this product regularly in order to get the most benefit||
0986|037|H|from it. To help you remember, use it at the same time(s) each||
0986|038|H|day.||
0986|039|H|   Tell your doctor if your condition does not get better in 7||
0986|040|H|days or if it gets worse. If you think you may have a serious||
0986|041|H|medical problem, get medical help right away.||
0986|042|B|||
0986|043|S|SIDE EFFECTS:  Redness, stinging, or irritation at the||
0986|044|S|application site may occur. If any of these effects last or get||
0986|045|S|worse, contact your doctor or pharmacist promptly.||
0986|046|S|   If your doctor has directed you to use this product, remember||
0986|047|S|that your doctor has judged that the benefit to you is greater||
0986|048|S|than the risk of side effects. Many people using this medication||
0986|049|S|do not have serious side effects.||
0986|050|S|   Stop using this medication and tell your doctor if you have||
0986|051|S|signs of a skin infection (such as heat, tenderness, pus).||
0986|052|S|   A very serious allergic reaction to this drug is rare.||
0986|053|S|However, get medical help right away if you notice any symptoms||
0986|054|S|of a serious allergic reaction, including: rash, itching/swelling||
0986|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0986|056|S|breathing.||
0986|057|S|   This is not a complete list of possible side effects. If you||
0986|058|S|notice other effects not listed above, contact your doctor or||
0986|059|S|pharmacist.||
0986|060|S|   In the US -||
0986|061|S|   Call your doctor for medical advice about side effects. You||
0986|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0986|063|S|www.fda.gov/medwatch.||
0986|064|S|   In Canada - Call your doctor for medical advice about side||
0986|065|S|effects. You may report side effects to Health Canada at||
0986|066|S|1-866-234-2345.||
0986|067|B|||
0986|068|P|PRECAUTIONS:  Before using hydrogen peroxide, tell your doctor or||
0986|069|P|pharmacist if you are allergic to it; or if you have any other||
0986|070|P|allergies. This product may contain inactive ingredients, which||
0986|071|P|can cause allergic reactions or other problems. Talk to your||
0986|072|P|pharmacist for more details.||
0986|073|P|   This product is safe to use during pregnancy.||
0986|074|P|   It is unlikely that this product passes into breast milk.||
0986|075|P|Consult your doctor before breastfeeding.||
0986|076|B|||
0986|077|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0986|078|I|medications work or increase your risk for serious side effects.||
0986|079|I|This document does not contain all possible drug interactions.||
0986|080|I|Keep a list of all the products you use (including||
0986|081|I|prescription/nonprescription drugs and herbal products) and share||
0986|082|I|it with your doctor and pharmacist. Do not start, stop, or change||
0986|083|I|the dosage of any medicines without your doctor's approval.||
0986|084|B|||
0986|085|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0986|086|O|has overdosed and has serious symptoms such as passing out or||
0986|087|O|trouble breathing, call 911. Otherwise, call a poison control||
0986|088|O|center right away. US residents can call 1-800-222-1222. Canada||
0986|089|O|residents can call 1-844-764-7669.||
0986|090|B|||
0986|091|N|NOTES:  Keep all medical and lab appointments.||
0986|092|B|||
0986|093|D|MISSED DOSE:  If you are using this product on a regular schedule||
0986|094|D|and miss a dose, use it as soon as you remember. If it is near||
0986|095|D|the time of the next dose, skip the missed dose. Use your next||
0986|096|D|dose at the regular time. Do not double the dose to catch up.||
0986|097|B|||
0986|098|R|STORAGE:  Refer to storage information printed on the package. If||
0986|099|R|you have any questions about storage, ask your pharmacist. Keep||
0986|100|R|all medications away from children and pets.||
0986|101|R|   Do not flush medications down the toilet or pour them into a||
0986|102|R|drain unless instructed to do so. Properly discard this product||
0986|103|R|when it is expired or no longer needed. Consult your pharmacist||
0986|104|R|or local waste disposal company.||
0986|105|B|||
0986|106|A|Information last revised November 2024.||
0986|107|A|Copyright(c) 2025 First Databank, Inc.||
0986|108|B|||
0987|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0987|002|Z|does NOT have all possible information about this product. This||
0987|003|Z|information does not assure that this product is safe, effective,||
0987|004|Z|or appropriate for you. This information is not individual||
0987|005|Z|medical advice and does not substitute for the advice of your||
0987|006|Z|health care professional. Always ask your health care||
0987|007|Z|professional for complete information about this product and your||
0987|008|Z|specific health needs.||
0987|009|B|||
0987|010|T|HYDROGEN PEROXIDE RINSE - ORAL||
0987|011|F|(HYE-droe-jen per-OX-ide)||
0987|012|B|||
0987|013|C|COMMON BRAND NAME(S): Peroxyl||
0987|014|B|||
0987|015|U|USES:  Hydrogen peroxide rinse is a mild antiseptic used in the||
0987|016|U|mouth to help relieve minor mouth irritation (such as due to||
0987|017|U|canker/cold sores, gingivitis, dentures, orthodontic appliances).||
0987|018|U|It works by releasing oxygen when it is applied to the affected||
0987|019|U|area. The release of oxygen causes foaming, which helps to remove||
0987|020|U|mucus and clean the area.||
0987|021|B|||
0987|022|H|HOW TO USE:  Follow all directions on the product package. If you||
0987|023|H|have any questions, ask your doctor or pharmacist.||
0987|024|H|   If you are using the liquid form, some brands need to be mixed||
0987|025|H|with water before using. Others are ready to use. Follow the||
0987|026|H|directions for your brand. Carefully measure the dose using the||
0987|027|H|cap provided by the manufacturer or a special measuring device.||
0987|028|H|Swish in the mouth over the affected area for at least 1 minute,||
0987|029|H|then spit out. Do not swallow this product.||
0987|030|H|   If you are using the gel form, apply several drops to the||
0987|031|H|affected area of the mouth. Some liquid forms may also be applied||
0987|032|H|directly to the affected area. Allow to remain in place for at||
0987|033|H|least 1 minute, then spit out. Do not swallow this product.||
0987|034|H|   Use up to 4 times daily or as directed by your dentist or||
0987|035|H|doctor.||
0987|036|H|   Use this product regularly in order to get the most benefit||
0987|037|H|from it. To help you remember, use it at the same time(s) each||
0987|038|H|day.||
0987|039|H|   Tell your doctor if your condition does not get better in 7||
0987|040|H|days or if it gets worse. If you think you may have a serious||
0987|041|H|medical problem, get medical help right away.||
0987|042|B|||
0987|043|S|SIDE EFFECTS:  Redness, stinging, or irritation at the||
0987|044|S|application site may occur. If any of these effects last or get||
0987|045|S|worse, contact your doctor or pharmacist promptly.||
0987|046|S|   If your doctor has directed you to use this product, remember||
0987|047|S|that your doctor has judged that the benefit to you is greater||
0987|048|S|than the risk of side effects. Many people using this product do||
0987|049|S|not have serious side effects.||
0987|050|S|   A very serious allergic reaction to this drug is rare.||
0987|051|S|However, get medical help right away if you notice any symptoms||
0987|052|S|of a serious allergic reaction, including: rash, itching/swelling||
0987|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0987|054|S|breathing.||
0987|055|S|   This is not a complete list of possible side effects. If you||
0987|056|S|notice other effects not listed above, contact your doctor or||
0987|057|S|pharmacist.||
0987|058|S|   In the US -||
0987|059|S|   Call your doctor for medical advice about side effects. You||
0987|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0987|061|S|www.fda.gov/medwatch.||
0987|062|S|   In Canada - Call your doctor for medical advice about side||
0987|063|S|effects. You may report side effects to Health Canada at||
0987|064|S|1-866-234-2345.||
0987|065|B|||
0987|066|P|PRECAUTIONS:  Before using hydrogen peroxide, tell your doctor or||
0987|067|P|pharmacist if you are allergic to it; or if you have any other||
0987|068|P|allergies. This product may contain inactive ingredients, which||
0987|069|P|can cause allergic reactions or other problems. Talk to your||
0987|070|P|pharmacist for more details.||
0987|071|P|   This product is safe to use during pregnancy.||
0987|072|P|   It is unlikely that this product passes into breast milk.||
0987|073|P|Consult your doctor before breastfeeding.||
0987|074|B|||
0987|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0987|076|I|medications work or increase your risk for serious side effects.||
0987|077|I|This document does not contain all possible drug interactions.||
0987|078|I|Keep a list of all the products you use (including||
0987|079|I|prescription/nonprescription drugs and herbal products) and share||
0987|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
0987|081|I|the dosage of any medicines without your doctor's approval.||
0987|082|B|||
0987|083|O|OVERDOSE:  This product may be harmful if more than the amount||
0987|084|O|used to rinse is swallowed. If someone has overdosed and has||
0987|085|O|serious symptoms such as passing out or trouble breathing, call||
0987|086|O|911. Otherwise, call a poison control center right away. US||
0987|087|O|residents can call 1-800-222-1222. Canada residents can call||
0987|088|O|1-844-764-7669.||
0987|089|B|||
0987|090|N|NOTES:  Keep all medical and lab appointments.||
0987|091|B|||
0987|092|D|MISSED DOSE:  If you are using this product on a regular schedule||
0987|093|D|and miss a dose, use it as soon as you remember. If it is near||
0987|094|D|the time of the next dose, skip the missed dose. Use your next||
0987|095|D|dose at the regular time. Do not double the dose to catch up.||
0987|096|B|||
0987|097|R|STORAGE:  Refer to storage information printed on the package. If||
0987|098|R|you have any questions about storage, ask your pharmacist. Keep||
0987|099|R|all medications away from children and pets.||
0987|100|R|   Do not flush medications down the toilet or pour them into a||
0987|101|R|drain unless instructed to do so. Properly discard this product||
0987|102|R|when it is expired or no longer needed. Consult your pharmacist||
0987|103|R|or local waste disposal company.||
0987|104|B|||
0987|105|A|Information last revised November 2024.||
0987|106|A|Copyright(c) 2025 First Databank, Inc.||
0987|107|B|||
0988|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0988|002|Z|does NOT have all possible information about this product. This||
0988|003|Z|information does not assure that this product is safe, effective,||
0988|004|Z|or appropriate for you. This information is not individual||
0988|005|Z|medical advice and does not substitute for the advice of your||
0988|006|Z|health care professional. Always ask your health care||
0988|007|Z|professional for complete information about this product and your||
0988|008|Z|specific health needs.||
0988|009|B|||
0988|010|T|CYCLOBENZAPRINE EXTENDED-RELEASE - ORAL||
0988|011|F|(sye-klo-BENZ-uh-preen)||
0988|012|B|||
0988|013|C|COMMON BRAND NAME(S): Amrix||
0988|014|B|||
0988|015|U|USES:  Cyclobenzaprine is used short-term to treat muscle spasms.||
0988|016|U|It is usually used along with rest and physical therapy. It works||
0988|017|U|by helping to relax the muscles.||
0988|018|U|   This medication is not recommended for use in older adults||
0988|019|U|because they may be at greater risk for side effects while using||
0988|020|U|this drug. Ask the doctor or pharmacist for details.||
0988|021|B|||
0988|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0988|023|H|from your pharmacist before you start taking cyclobenzaprine and||
0988|024|H|each time you get a refill. If you have any questions, ask your||
0988|025|H|doctor or pharmacist.||
0988|026|H|   Take this medication by mouth with or without food as directed||
0988|027|H|by your doctor, usually once daily. Swallow the capsules whole.||
0988|028|H|Do not crush or chew the capsules. Doing so can release all of||
0988|029|H|the drug at once, increasing the risk of side effects. If you||
0988|030|H|have trouble swallowing the capsule, you may open the capsule and||
0988|031|H|carefully sprinkle its contents on a tablespoon of applesauce.||
0988|032|H|Swallow all of the mixture right away without chewing it. Then||
0988|033|H|rinse your mouth with water and swallow the rinse liquid to make||
0988|034|H|sure you have swallowed all of the medication. Do not prepare the||
0988|035|H|mixture ahead of time for later use. Doing so may destroy the||
0988|036|H|drug.||
0988|037|H|   The dosage is based on your medical condition and response to||
0988|038|H|treatment. This medication should only be used short-term (for 3||
0988|039|H|weeks or less) unless directed by your doctor. Do not increase||
0988|040|H|your dose or use this drug more often or for longer than||
0988|041|H|prescribed. Your condition will not improve any faster, and your||
0988|042|H|risk of side effects will increase.||
0988|043|H|   Tell your doctor if your condition lasts after 2 to 3 weeks or||
0988|044|H|if it gets worse.||
0988|045|B|||
0988|046|S|SIDE EFFECTS:  Drowsiness, dizziness, dry mouth, or tiredness may||
0988|047|S|occur. If any of these effects last or get worse, tell your||
0988|048|S|doctor or pharmacist promptly.||
0988|049|S|   Remember that this medication has been prescribed because your||
0988|050|S|doctor has judged that the benefit to you is greater than the||
0988|051|S|risk of side effects. Many people using this medication do not||
0988|052|S|have serious side effects.||
0988|053|S|   Tell your doctor right away if you have any serious side||
0988|054|S|effects, including: fast/irregular heartbeat, mental/mood changes||
0988|055|S|(such as confusion, hallucinations).||
0988|056|S|   A very serious allergic reaction to this drug is rare.||
0988|057|S|However, get medical help right away if you notice any symptoms||
0988|058|S|of a serious allergic reaction, including: rash, itching/swelling||
0988|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0988|060|S|breathing.||
0988|061|S|   This is not a complete list of possible side effects. If you||
0988|062|S|notice other effects not listed above, contact your doctor or||
0988|063|S|pharmacist.||
0988|064|S|   In the US -||
0988|065|S|   Call your doctor for medical advice about side effects. You||
0988|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0988|067|S|www.fda.gov/medwatch.||
0988|068|S|   In Canada - Call your doctor for medical advice about side||
0988|069|S|effects. You may report side effects to Health Canada at||
0988|070|S|1-866-234-2345.||
0988|071|B|||
0988|072|P|PRECAUTIONS:  Before taking cyclobenzaprine, tell your doctor or||
0988|073|P|pharmacist if you are allergic to it; or if you have any other||
0988|074|P|allergies. This product may contain inactive ingredients, which||
0988|075|P|can cause allergic reactions or other problems. Talk to your||
0988|076|P|pharmacist for more details.||
0988|077|P|   Before using this medication, tell your doctor or pharmacist||
0988|078|P|your medical history, especially of: liver disease, overactive||
0988|079|P|thyroid (hyperthyroidism), heart problems (such as irregular||
0988|080|P|heartbeat, heart block, heart failure, recent heart attack),||
0988|081|P|difficulty urinating (such as due to an enlarged prostate),||
0988|082|P|glaucoma.||
0988|083|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
0988|084|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
0988|085|P|machinery, or do anything that needs alertness until you can do||
0988|086|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
0988|087|P|are using marijuana (cannabis).||
0988|088|P|   Before having surgery, tell your doctor or dentist about all||
0988|089|P|the products you use (including prescription drugs,||
0988|090|P|nonprescription drugs, and herbal products).||
0988|091|P|   During pregnancy, this medication should be used only when||
0988|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
0988|093|P|   This medication passes into breast milk. Consult your doctor||
0988|094|P|before breastfeeding.||
0988|095|B|||
0988|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0988|097|I|medications work or increase your risk for serious side effects.||
0988|098|I|This document does not contain all possible drug interactions.||
0988|099|I|Keep a list of all the products you use (including||
0988|100|I|prescription/nonprescription drugs and herbal products) and share||
0988|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
0988|102|I|the dosage of any medicines without your doctor's approval.||
0988|103|I|   Some products that may interact with this drug include:||
0988|104|I|tricyclic antidepressants (such as amitriptyline, imipramine).||
0988|105|I|   Taking MAO inhibitors with this medication may cause a serious||
0988|106|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
0988|107|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
0988|108|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
0988|109|I|selegiline, tranylcypromine) during treatment with this||
0988|110|I|medication. Most MAO inhibitors should also not be taken for two||
0988|111|I|weeks before treatment with this medication. Ask your doctor when||
0988|112|I|to start or stop taking this medication.||
0988|113|I|   Before using this medication, report the use of drugs that||
0988|114|I|increase serotonin, including street drugs (such as||
0988|115|I|MDMA/"ecstasy"), St. John's wort, certain antidepressants||
0988|116|I|(including SSRIs such as fluoxetine/paroxetine, SNRIs such as||
0988|117|I|duloxetine/venlafaxine), tramadol, among others.||
0988|118|I|   Tell your doctor or pharmacist if you are taking other||
0988|119|I|products that cause drowsiness such as opioid pain or cough||
0988|120|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0988|121|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0988|122|I|lorazepam, zolpidem), other muscle relaxants (such as||
0988|123|I|carisoprodol, methocarbamol), or antihistamines (such as||
0988|124|I|cetirizine, diphenhydramine).||
0988|125|I|   Check the labels on all your medicines (such as allergy or||
0988|126|I|cough-and-cold products) because they may contain ingredients||
0988|127|I|that cause drowsiness. Ask your pharmacist about using those||
0988|128|I|products safely.||
0988|129|B|||
0988|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0988|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0988|132|O|poison control center right away. US residents can call||
0988|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0988|134|O|Symptoms of overdose may include: fast/irregular heartbeat,||
0988|135|O|fainting, severe drowsiness, trouble speaking, seizures,||
0988|136|O|mental/mood changes (such as confusion, hallucinations).||
0988|137|B|||
0988|138|N|NOTES:  Do not share this medication with others.||
0988|139|N|   This medication has been prescribed for your current condition||
0988|140|N|only. Do not use it later for another condition unless your||
0988|141|N|doctor directs you to do so. A different medication may be||
0988|142|N|necessary in that case.||
0988|143|B|||
0988|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0988|145|D|remember. If it is near the time of the next dose, skip the||
0988|146|D|missed dose. Take your next dose at the regular time. Do not||
0988|147|D|double the dose to catch up.||
0988|148|B|||
0988|149|R|STORAGE:  Store at room temperature away from light and moisture.||
0988|150|R|Do not store in the bathroom. Keep all medications away from||
0988|151|R|children and pets.||
0988|152|R|   Do not flush medications down the toilet or pour them into a||
0988|153|R|drain unless instructed to do so. Properly discard this product||
0988|154|R|when it is expired or no longer needed. Consult your pharmacist||
0988|155|R|or local waste disposal company.||
0988|156|B|||
0988|157|A|Information last revised August 2025.||
0988|158|A|Copyright(c) 2025 First Databank, Inc.||
0988|159|B|||
0989|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0989|002|Z|does NOT have all possible information about this product. This||
0989|003|Z|information does not assure that this product is safe, effective,||
0989|004|Z|or appropriate for you. This information is not individual||
0989|005|Z|medical advice and does not substitute for the advice of your||
0989|006|Z|health care professional. Always ask your health care||
0989|007|Z|professional for complete information about this product and your||
0989|008|Z|specific health needs.||
0989|009|B|||
0989|010|T|PHENYLEPHRINE/PRAMOXINE HEMORRHOIDAL CREAM - RECTAL||
0989|011|F|(FEN-il-EF-rin/pram-OX-een)||
0989|012|B|||
0989|013|C|COMMON BRAND NAME(S): Preparation H||
0989|014|B|||
0989|015|U|USES:  This medication is used to temporarily relieve swelling,||
0989|016|U|burning, pain, and itching caused by hemorrhoids. This product||
0989|017|U|contains phenylephrine and pramoxine.||
0989|018|U|   Phenylephrine is a sympathomimetic amine that works by||
0989|019|U|temporarily narrowing the blood vessels in the area. This effect||
0989|020|U|decreases swelling and discomfort. Pramoxine belongs to a class||
0989|021|U|of drugs known as local anesthetics. It works on nerves in the||
0989|022|U|skin to block or reduce the feeling of pain and itching.||
0989|023|U|   Some products may also contain substances (such as cocoa||
0989|024|U|butter, hard fat, mineral oil, shark liver oil) that soothe or||
0989|025|U|form a protective barrier to prevent too much irritating contact||
0989|026|U|with stool.||
0989|027|U|   Do not use this product in children 12 years or younger||
0989|028|U|without talking with the doctor.||
0989|029|B|||
0989|030|H|HOW TO USE:  Follow all directions on the product package. If you||
0989|031|H|have any questions, ask your doctor or pharmacist. Before use,||
0989|032|H|clean the area with mild soap and water, rinse well, and pat dry.||
0989|033|H|   Apply the product to the skin of the affected area up to 4||
0989|034|H|times daily, usually in the morning and bedtime, or after each||
0989|035|H|bowel movement, or as directed by your doctor. To apply this||
0989|036|H|product inside the lower part of the anus, use the applicator||
0989|037|H|tip/cap/nozzle. Follow all instructions in the product package,||
0989|038|H|or use as directed by your doctor. Do not apply the product high||
0989|039|H|up inside the rectum.||
0989|040|H|   Dosage is based on your medical condition and response to||
0989|041|H|treatment. Do not use more often or for a longer time than||
0989|042|H|recommended.||
0989|043|H|   Tell your doctor if your symptoms do not get better within 7||
0989|044|H|days or if bleeding/worsening pain occurs. If you think you may||
0989|045|H|have a serious medical problem, get medical help right away.||
0989|046|B|||
0989|047|S|SIDE EFFECTS:  This medication does not usually have bothersome||
0989|048|S|side effects when used as directed. Mild pain/stinging may occur.||
0989|049|S|If any of these effects last or get worse, tell your doctor or||
0989|050|S|pharmacist promptly.||
0989|051|S|   If your doctor has directed you to use this medication,||
0989|052|S|remember that your doctor has judged that the benefit to you is||
0989|053|S|greater than the risk of side effects. Many people using this||
0989|054|S|medication do not have serious side effects.||
0989|055|S|   Stop using this medication and tell your doctor right away if||
0989|056|S|you have any serious side effects, including: fast/irregular||
0989|057|S|heartbeat, pounding headache, nervousness, shakiness (tremor),||
0989|058|S|trouble sleeping.||
0989|059|S|   A very serious allergic reaction to this drug is rare.||
0989|060|S|However, get medical help right away if you notice any symptoms||
0989|061|S|of a serious allergic reaction, including: rash, itching/swelling||
0989|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0989|063|S|breathing.||
0989|064|S|   This is not a complete list of possible side effects. If you||
0989|065|S|notice other effects not listed above, contact your doctor or||
0989|066|S|pharmacist.||
0989|067|S|   In the US -||
0989|068|S|   Call your doctor for medical advice about side effects. You||
0989|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0989|070|S|www.fda.gov/medwatch.||
0989|071|S|   In Canada - Call your doctor for medical advice about side||
0989|072|S|effects. You may report side effects to Health Canada at||
0989|073|S|1-866-234-2345.||
0989|074|B|||
0989|075|P|PRECAUTIONS:  Before using this product, tell your doctor or||
0989|076|P|pharmacist if you are allergic to phenylephrine; or to pramoxine;||
0989|077|P|or to any of its ingredients; or if you have any other allergies.||
0989|078|P|This product may contain inactive ingredients, which can cause||
0989|079|P|allergic reactions or other problems. Talk to your pharmacist for||
0989|080|P|more details.||
0989|081|P|   If you have any of the following health problems, consult your||
0989|082|P|doctor or pharmacist before using this product: diabetes, heart||
0989|083|P|problems (such as chest pain, heart attack), high blood pressure,||
0989|084|P|overactive thyroid (hyperthyroidism), difficult urination due to||
0989|085|P|blockage (for example, caused by an enlarged prostate).||
0989|086|P|   Before having surgery, tell your doctor or dentist about all||
0989|087|P|the products you use (including prescription drugs,||
0989|088|P|nonprescription drugs, and herbal products).||
0989|089|P|   During pregnancy, this medication should be used only when||
0989|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
0989|091|P|   It is unknown if this drug passes into breast milk. Consult||
0989|092|P|your doctor before breastfeeding.||
0989|093|B|||
0989|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0989|095|I|medications work or increase your risk for serious side effects.||
0989|096|I|This document does not contain all possible drug interactions.||
0989|097|I|Keep a list of all the products you use (including||
0989|098|I|prescription/nonprescription drugs and herbal products) and share||
0989|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
0989|100|I|the dosage of any medicines without your doctor's approval.||
0989|101|B|||
0989|102|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0989|103|O|has overdosed and has serious symptoms such as passing out or||
0989|104|O|trouble breathing, call 911. Otherwise, call a poison control||
0989|105|O|center right away. US residents can call 1-800-222-1222. Canada||
0989|106|O|residents can call 1-844-764-7669.||
0989|107|B|||
0989|108|N|NOTES:  To maintain normal bowel function and reduce the risk of||
0989|109|N|hemorrhoids, eat a proper diet high in fiber, drink 6 to 8||
0989|110|N|glasses of water each day, and exercise regularly.||
0989|111|B|||
0989|112|D|MISSED DOSE:  If you are using this product on a regular schedule||
0989|113|D|and miss a dose, use it as soon as you remember. If it is near||
0989|114|D|the time of the next dose, skip the missed dose. Use your next||
0989|115|D|dose at the regular time. Do not double the dose to catch up.||
0989|116|B|||
0989|117|R|STORAGE:  Store at room temperature. Different brands of this||
0989|118|R|medication may have different storage needs. Check the product||
0989|119|R|package for instructions on how to store your brand, or ask your||
0989|120|R|pharmacist. Keep all medications away from children and pets.||
0989|121|R|   Do not flush medications down the toilet or pour them into a||
0989|122|R|drain unless instructed to do so. Properly discard this product||
0989|123|R|when it is expired or no longer needed. Consult your pharmacist||
0989|124|R|or local waste disposal company.||
0989|125|B|||
0989|126|A|Information last revised June 2025.||
0989|127|A|Copyright(c) 2025 First Databank, Inc.||
0989|128|B|||
0990|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0990|002|Z|does NOT have all possible information about this product. This||
0990|003|Z|information does not assure that this product is safe, effective,||
0990|004|Z|or appropriate for you. This information is not individual||
0990|005|Z|medical advice and does not substitute for the advice of your||
0990|006|Z|health care professional. Always ask your health care||
0990|007|Z|professional for complete information about this product and your||
0990|008|Z|specific health needs.||
0990|009|B|||
0990|010|T|MARAVIROC - ORAL||
0990|011|F|(MAR-a-VIR-ok)||
0990|012|B|||
0990|013|C|COMMON BRAND NAME(S): Selzentry||
0990|014|B|||
0990|015|W|WARNING:  This medication may rarely cause serious liver||
0990|016|W|problems. Symptoms of a serious allergic reaction may occur||
0990|017|W|before liver problems develop. Get medical help right away if you||
0990|018|W|have any symptoms of a serious allergic reaction or possible||
0990|019|W|liver damage such as: nausea/vomiting that doesn't stop, rash,||
0990|020|W|yellowing eyes/skin, dark urine, extreme tiredness. (See also||
0990|021|W|Side Effects section.)||
0990|022|B|||
0990|023|U|USES:  Maraviroc is used with other HIV medications to help||
0990|024|U|control HIV infection. It helps to decrease the amount of HIV in||
0990|025|U|your body so your immune system can work better. This lowers your||
0990|026|U|chance of getting HIV complications (such as new infections,||
0990|027|U|cancer) and improves your quality of life. Maraviroc belongs to a||
0990|028|U|class of drugs known as entry inhibitors. It works by blocking||
0990|029|U|the HIV virus from infecting healthy immune cells (T-cells).||
0990|030|U|   Maraviroc is not a cure for HIV infection. To decrease your||
0990|031|U|risk of spreading HIV disease to others, continue to take all HIV||
0990|032|U|medications exactly as prescribed by your doctor. Use an||
0990|033|U|effective barrier method (latex or polyurethane condoms/dental||
0990|034|U|dams) during sexual activity as directed by your doctor. Do not||
0990|035|U|share personal items (such as needles/syringes, toothbrushes, and||
0990|036|U|razors) that may have contacted blood or other body fluids.||
0990|037|U|Consult your doctor or pharmacist for more details.||
0990|038|B|||
0990|039|V|OTHER USES:  This section contains uses of this drug that are not||
0990|040|V|listed in the approved professional labeling for the drug but||
0990|041|V|that may be prescribed by your health care professional. Use this||
0990|042|V|drug for a condition that is listed in this section only if it||
0990|043|V|has been so prescribed by your health care professional.||
0990|044|V|   This product may also be used to lessen the risk of HIV||
0990|045|V|infection after contact with the virus (for example, due to a||
0990|046|V|needle stick). Ask your doctor for more details.||
0990|047|B|||
0990|048|H|HOW TO USE:  Read the Medication Guide provided by your||
0990|049|H|pharmacist before you start using maraviroc and each time you get||
0990|050|H|a refill. If you are using the liquid form of this medication,||
0990|051|H|also read the Instructions for Use. If you have any questions,||
0990|052|H|ask your doctor or pharmacist.||
0990|053|H|   Take this medication by mouth with or without food as directed||
0990|054|H|by your doctor, usually twice daily.||
0990|055|H|   The manufacturer directs not to split, crush, or chew the||
0990|056|H|tablet before taking it. However, many similar drugs||
0990|057|H|(immediate-release tablets) can be split, crushed, or chewed.||
0990|058|H|Follow your doctor's directions on how to take this medication.||
0990|059|H|   If you are using the liquid form of this medication, carefully||
0990|060|H|measure the dose using a special measuring device/spoon. Do not||
0990|061|H|use a household spoon because you may not get the correct dose.||
0990|062|H|   The dosage is based on your medical condition, response to||
0990|063|H|treatment, and other medications you may be taking. Children's||
0990|064|H|dosage is also based on weight. Be sure to tell your doctor and||
0990|065|H|pharmacist about all the products you use (including prescription||
0990|066|H|drugs, nonprescription drugs, and herbal products).||
0990|067|H|   It is very important to keep taking this medication (and other||
0990|068|H|HIV medications) exactly as prescribed by your doctor.||
0990|069|H|   For the best effect, take this medication at evenly spaced||
0990|070|H|times. To help you remember, take this medication at the same||
0990|071|H|times every day.||
0990|072|H|   Do not take more or less of this drug than prescribed or stop||
0990|073|H|taking it (or other HIV medicines) even for a short time unless||
0990|074|H|directed to do so by your doctor. Doing so may cause the amount||
0990|075|H|of virus to increase, make the infection more difficult to treat||
0990|076|H|(resistant), or worsen side effects.||
0990|077|B|||
0990|078|S|SIDE EFFECTS:  See also Warning section.||
0990|079|S|   Cough, stomach pain, or tiredness may occur. Lightheadedness||
0990|080|S|or dizziness while standing may also occur. If any of these||
0990|081|S|effects last or get worse, tell your doctor or pharmacist||
0990|082|S|promptly.||
0990|083|S|   To reduce the risk of dizziness and lightheadedness, get up||
0990|084|S|slowly when rising from a sitting or lying position.||
0990|085|S|   Remember that this medication has been prescribed because your||
0990|086|S|doctor has judged that the benefit to you is greater than the||
0990|087|S|risk of side effects. Many people using this medication do not||
0990|088|S|have serious side effects.||
0990|089|S|   As your immune system gets stronger, it can begin to fight off||
0990|090|S|infections you already had, possibly causing disease symptoms to||
0990|091|S|come back. You could also have symptoms if your immune system||
0990|092|S|becomes overactive. This reaction may happen at any time (soon||
0990|093|S|after starting HIV treatment or many months later). Tell your||
0990|094|S|doctor right away if you have any serious symptoms, including:||
0990|095|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
0990|096|S|that doesn't go away, headaches that are severe or don't go away,||
0990|097|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
0990|098|S|changes, signs of infection (such as sore throat that doesn't go||
0990|099|S|away, fever, chills, non-healing skin sores), signs of an||
0990|100|S|overactive thyroid (such as irritability, nervousness, heat||
0990|101|S|intolerance, fast/pounding/irregular heartbeat).||
0990|102|S|   Get medical help right away if you have any very serious side||
0990|103|S|effects, including: chest/jaw/left arm pain.||
0990|104|S|   A very serious allergic reaction to this drug is rare.||
0990|105|S|However, get medical help right away if you notice any symptoms||
0990|106|S|of a serious allergic reaction, including: swollen lymph nodes,||
0990|107|S|rash, itching/swelling (especially of the face/tongue/throat),||
0990|108|S|severe dizziness, trouble breathing.||
0990|109|S|   This is not a complete list of possible side effects. If you||
0990|110|S|notice other effects not listed above, contact your doctor or||
0990|111|S|pharmacist.||
0990|112|S|   In the US -||
0990|113|S|   Call your doctor for medical advice about side effects. You||
0990|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0990|115|S|www.fda.gov/medwatch.||
0990|116|S|   In Canada - Call your doctor for medical advice about side||
0990|117|S|effects. You may report side effects to Health Canada at||
0990|118|S|1-866-234-2345.||
0990|119|B|||
0990|120|P|PRECAUTIONS:  Before taking maraviroc, tell your doctor or||
0990|121|P|pharmacist if you are allergic to it; or if you have any other||
0990|122|P|allergies. This product may contain inactive ingredients, which||
0990|123|P|can cause allergic reactions or other problems. Talk to your||
0990|124|P|pharmacist for more details.||
0990|125|P|   Before taking this medication, tell your doctor or pharmacist||
0990|126|P|your medical history, especially of: heart disease (such as||
0990|127|P|previous heart attack), kidney disease, liver problems (including||
0990|128|P|hepatitis B or C infection), low blood pressure.||
0990|129|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0990|130|P|can make you more dizzy. Do not drive, use machinery, or do||
0990|131|P|anything that needs alertness until you can do it safely. Limit||
0990|132|P|alcoholic beverages. Talk to your doctor if you are using||
0990|133|P|marijuana (cannabis).||
0990|134|P|   Before having surgery, tell your doctor or dentist about all||
0990|135|P|the products you use (including prescription drugs,||
0990|136|P|nonprescription drugs, and herbal products).||
0990|137|P|   During pregnancy, this medication should be used only when||
0990|138|P|clearly needed. Treatment can lower the risk of passing HIV||
0990|139|P|infection to your baby, and maraviroc may be part of that||
0990|140|P|treatment. Discuss the risks and benefits with your doctor.||
0990|141|P|   It is unknown if this medication passes into breast milk.||
0990|142|P|Because breast milk may transmit HIV, consult your doctor before||
0990|143|P|breastfeeding.||
0990|144|B|||
0990|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0990|146|I|medications work or increase your risk for serious side effects.||
0990|147|I|This document does not contain all possible drug interactions.||
0990|148|I|Keep a list of all the products you use (including||
0990|149|I|prescription/nonprescription drugs and herbal products) and share||
0990|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
0990|151|I|the dosage of any medicines without your doctor's approval.||
0990|152|I|   Some products that may interact with this drug are: orlistat,||
0990|153|I|St. John's wort.||
0990|154|B|||
0990|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0990|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0990|157|O|poison control center right away. US residents can call||
0990|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0990|159|B|||
0990|160|N|NOTES:  Do not share this medication with others.||
0990|161|N|   Lab and/or medical tests (such as liver function, viral load,||
0990|162|N|T-cell counts) should be done before you start taking this||
0990|163|N|medication and while you are taking it. Keep all medical and lab||
0990|164|N|appointments. Consult your doctor for more details.||
0990|165|B|||
0990|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0990|167|D|remember. If it is near the time of the next dose, skip the||
0990|168|D|missed dose. Take your next dose at the regular time. Do not||
0990|169|D|double the dose to catch up.||
0990|170|B|||
0990|171|R|STORAGE:  Store at room temperature away from light and moisture.||
0990|172|R|Do not store in the bathroom. Keep all medications away from||
0990|173|R|children and pets.||
0990|174|R|   Do not flush medications down the toilet or pour them into a||
0990|175|R|drain unless instructed to do so. Properly discard this product||
0990|176|R|when it is expired or no longer needed. Consult your pharmacist||
0990|177|R|or local waste disposal company.||
0990|178|B|||
0990|179|A|Information last revised April 2025.||
0990|180|A|Copyright(c) 2025 First Databank, Inc.||
0990|181|B|||
0991|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0991|002|Z|does NOT have all possible information about this product. This||
0991|003|Z|information does not assure that this product is safe, effective,||
0991|004|Z|or appropriate for you. This information is not individual||
0991|005|Z|medical advice and does not substitute for the advice of your||
0991|006|Z|health care professional. Always ask your health care||
0991|007|Z|professional for complete information about this product and your||
0991|008|Z|specific health needs.||
0991|009|B|||
0991|010|T|TYPHOID VACCINE - INJECTION||
0991|011|B|||
0991|012|C|COMMON BRAND NAME(S): Typhim VI||
0991|013|B|||
0991|014|U|USES:  This vaccine is used to help prevent typhoid fever.||
0991|015|U|Typhoid fever is an infection that can be spread by eating||
0991|016|U|contaminated food or drinking contaminated water. This vaccine||
0991|017|U|works by increasing the body's natural defense (immunity) against||
0991|018|U|the bacteria.||
0991|019|U|   This vaccine is recommended for people who are traveling to||
0991|020|U|areas where the infection is common (such as Africa, Asia,||
0991|021|U|Central/South America), those who are in close contact to someone||
0991|022|U|with an ongoing typhoid infection, and those who work with the||
0991|023|U|bacteria (Salmonella typhi) in a lab.||
0991|024|U|   Vaccines may not fully protect everyone who receives them.||
0991|025|B|||
0991|026|H|HOW TO USE:  Read all vaccine information available from your||
0991|027|H|health care professional before receiving the vaccine. If you||
0991|028|H|have any questions, ask your health care professional.||
0991|029|H|   This vaccine is given by injection into a muscle by a health||
0991|030|H|care professional. It is given in the upper arm for adults or in||
0991|031|H|the thigh or upper arm for children.||
0991|032|H|   This vaccine should be given as a single injection at least 2||
0991|033|H|weeks before possible exposure to typhoid fever. It can be given||
0991|034|H|every 2 years thereafter if needed.||
0991|035|B|||
0991|036|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
0991|037|S|headache, or muscle pain may occur. If any of these effects last||
0991|038|S|or get worse, tell your health care professional promptly.||
0991|039|S|   Rarely, some people have symptoms such as fainting, dizziness,||
0991|040|S|vision changes, or ringing in the ears just after getting a||
0991|041|S|vaccine injection. Tell your health care professional right away||
0991|042|S|if you have any of these symptoms. Sitting or lying down may||
0991|043|S|help, since these symptoms usually don't last long.||
0991|044|S|   Remember that this vaccine has been prescribed because your||
0991|045|S|health care professional has judged that the benefit to you is||
0991|046|S|greater than the risk of side effects. Many people using this||
0991|047|S|vaccine do not have serious side effects.||
0991|048|S|   A very serious allergic reaction to this vaccine is rare.||
0991|049|S|However, get medical help right away if you notice any symptoms||
0991|050|S|of a serious allergic reaction, including: rash, itching/swelling||
0991|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0991|052|S|breathing.||
0991|053|S|   This is not a complete list of possible side effects. If you||
0991|054|S|notice other effects not listed above, contact your health care||
0991|055|S|professional.||
0991|056|S|   Contact the health care professional for medical advice about||
0991|057|S|side effects. The following numbers do not provide medical||
0991|058|S|advice, but in the US you may report side effects to the Vaccine||
0991|059|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
0991|060|S|Canada, you may call the Vaccine Safety Section at Public Health||
0991|061|S|Agency of Canada at 1-866-844-0018.||
0991|062|B|||
0991|063|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
0991|064|P|care professional if you are allergic to it; or if you have any||
0991|065|P|other allergies. This product may contain inactive ingredients,||
0991|066|P|which can cause allergic reactions or other problems. Talk to||
0991|067|P|your health care professional for more details.||
0991|068|P|   Before receiving this vaccine, tell your health care||
0991|069|P|professional your medical history, especially of: current||
0991|070|P|fever/illness, immune system disorders (such as due to HIV||
0991|071|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
0991|072|P|radiation treatment), vaccination history (including previous||
0991|073|P|reactions to any vaccines).||
0991|074|P|   During pregnancy, this vaccine should be used only when||
0991|075|P|clearly needed. Discuss the risks and benefits with your health||
0991|076|P|care professional.||
0991|077|P|   It is unknown if this vaccine passes into breast milk. Consult||
0991|078|P|your health care professional before breastfeeding.||
0991|079|B|||
0991|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0991|081|I|medications work or increase your risk for serious side effects.||
0991|082|I|This document does not contain all possible drug interactions.||
0991|083|I|Keep a list of all the products you use (including||
0991|084|I|prescription/nonprescription drugs and herbal products) and share||
0991|085|I|it with your health care professional. Do not start, stop, or||
0991|086|I|change the dosage of any medicines without your doctor's||
0991|087|I|approval.||
0991|088|I|   Some products that may interact with this vaccine are: drugs||
0991|089|I|that weaken the immune system (including cyclosporine,||
0991|090|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
0991|091|I|prednisone).||
0991|092|B|||
0991|093|O|OVERDOSE:  Not applicable.||
0991|094|B|||
0991|095|N|NOTES:  Keep all medical and lab appointments.||
0991|096|N|   Keep vaccine records for yourself and your children and||
0991|097|N|provide them to the health care professionals to prevent||
0991|098|N|unnecessary re-vaccinations.||
0991|099|B|||
0991|100|D|MISSED DOSE:  Not applicable.||
0991|101|B|||
0991|102|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
0991|103|R|light. Keep all medications away from children and pets.||
0991|104|R|   Do not flush medications down the toilet or pour them into a||
0991|105|R|drain unless instructed to do so. Properly discard this product||
0991|106|R|when it is expired or no longer needed. Consult your pharmacist||
0991|107|R|or local waste disposal company.||
0991|108|B|||
0991|109|A|Information last revised February 2025.||
0991|110|A|Copyright(c) 2025 First Databank, Inc.||
0991|111|B|||
0992|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0992|002|Z|does NOT have all possible information about this product. This||
0992|003|Z|information does not assure that this product is safe, effective,||
0992|004|Z|or appropriate for you. This information is not individual||
0992|005|Z|medical advice and does not substitute for the advice of your||
0992|006|Z|health care professional. Always ask your health care||
0992|007|Z|professional for complete information about this product and your||
0992|008|Z|specific health needs.||
0992|009|B|||
0992|010|T|HYDROXYZINE HYDROCHLORIDE - ORAL||
0992|011|F|(hye-DROX-i-zeen HYE-droe-KLOR-ide)||
0992|012|B|||
0992|013|C|COMMON BRAND NAME(S): Atarax||
0992|014|B|||
0992|015|U|USES:  Hydroxyzine is used to treat itching caused by allergies.||
0992|016|U|It is an antihistamine and works by blocking a certain natural||
0992|017|U|substance (histamine) that your body makes during an allergic||
0992|018|U|reaction. Hydroxyzine may also be used short-term to treat||
0992|019|U|anxiety or to help you feel sleepy/relaxed before and after||
0992|020|U|surgery.||
0992|021|B|||
0992|022|H|HOW TO USE:  Take this medication by mouth with or without food||
0992|023|H|as directed by your doctor, usually three or four times daily. If||
0992|024|H|you are using the liquid form of this medication, carefully||
0992|025|H|measure the dose using a special measuring device/spoon. Do not||
0992|026|H|use a household spoon because you may not get the correct dose.||
0992|027|H|   The dosage is based on your age, medical condition, and||
0992|028|H|response to treatment. Children's dosage may also be based on||
0992|029|H|weight. Do not increase your dose or take this medication more||
0992|030|H|often than directed.||
0992|031|H|   Tell your doctor if your condition does not get better or if||
0992|032|H|it gets worse.||
0992|033|B|||
0992|034|S|SIDE EFFECTS:  Drowsiness, dizziness, blurred vision,||
0992|035|S|constipation, or dry mouth may occur. If any of these effects||
0992|036|S|last or get worse, tell your doctor or pharmacist promptly.||
0992|037|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0992|038|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0992|039|S|substitute.||
0992|040|S|   Remember that this medication has been prescribed because your||
0992|041|S|doctor has judged that the benefit to you is greater than the||
0992|042|S|risk of side effects. Many people using this medication do not||
0992|043|S|have serious side effects.||
0992|044|S|   Tell your doctor right away if you have any serious side||
0992|045|S|effects, including: mental/mood changes (such as restlessness,||
0992|046|S|confusion, hallucinations), shaking (tremor), difficulty||
0992|047|S|urinating.||
0992|048|S|   Get medical help right away if you have any very serious side||
0992|049|S|effects, including: seizures, fast/irregular heartbeat, severe||
0992|050|S|dizziness, fainting.||
0992|051|S|   A very serious allergic reaction to this drug is rare.||
0992|052|S|However, get medical help right away if you notice any symptoms||
0992|053|S|of a serious allergic reaction, including: rash, itching/swelling||
0992|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0992|055|S|breathing.||
0992|056|S|   This is not a complete list of possible side effects. If you||
0992|057|S|notice other effects not listed above, contact your doctor or||
0992|058|S|pharmacist.||
0992|059|S|   In the US -||
0992|060|S|   Call your doctor for medical advice about side effects. You||
0992|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0992|062|S|www.fda.gov/medwatch.||
0992|063|S|   In Canada - Call your doctor for medical advice about side||
0992|064|S|effects. You may report side effects to Health Canada at||
0992|065|S|1-866-234-2345.||
0992|066|B|||
0992|067|P|PRECAUTIONS:  Before taking hydroxyzine, tell your doctor or||
0992|068|P|pharmacist if you are allergic to it; or to cetirizine; or to||
0992|069|P|levocetirizine; or if you have any other allergies. This product||
0992|070|P|may contain inactive ingredients, which can cause allergic||
0992|071|P|reactions or other problems. Talk to your pharmacist for more||
0992|072|P|details.||
0992|073|P|   Before using this medication, tell your doctor or pharmacist||
0992|074|P|your medical history, especially of: breathing problems (such as||
0992|075|P|emphysema, asthma), high pressure in the eye (glaucoma), high||
0992|076|P|blood pressure, kidney problems, liver problems, seizures,||
0992|077|P|stomach/intestine problems (such as ulcer, blockage), overactive||
0992|078|P|thyroid (hyperthyroidism), difficulty urinating (for example, due||
0992|079|P|to enlarged prostate).||
0992|080|P|   Hydroxyzine may cause a condition that affects the heart||
0992|081|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0992|082|P|serious (rarely fatal) fast/irregular heartbeat and other||
0992|083|P|symptoms (such as severe dizziness, fainting) that need medical||
0992|084|P|attention right away.||
0992|085|P|   The risk of QT prolongation may be increased if you have||
0992|086|P|certain medical conditions or are taking other drugs that may||
0992|087|P|cause QT prolongation. Before taking hydroxyzine, tell your||
0992|088|P|doctor or pharmacist of all the drugs you take and if you have||
0992|089|P|any of the following conditions: certain heart problems (heart||
0992|090|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0992|091|P|history of certain heart problems (QT prolongation in the EKG,||
0992|092|P|sudden cardiac death).||
0992|093|P|   Low levels of potassium or magnesium in the blood may also||
0992|094|P|increase your risk of QT prolongation. This risk may increase if||
0992|095|P|you use certain drugs (such as diuretics/"water pills") or if you||
0992|096|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0992|097|P|Talk to your doctor about taking hydroxyzine safely.||
0992|098|P|   This drug may make you dizzy or drowsy or blur your vision.||
0992|099|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0992|100|P|drowsy. Do not drive, use machinery, or do anything that needs||
0992|101|P|alertness or clear vision until you can do it safely. Avoid||
0992|102|P|alcoholic beverages. Talk to your doctor if you are using||
0992|103|P|marijuana (cannabis).||
0992|104|P|   Before having surgery, tell your doctor or dentist about all||
0992|105|P|the products you use (including prescription drugs,||
0992|106|P|nonprescription drugs, and herbal products).||
0992|107|P|   Liquid products may contain sugar and/or alcohol. Caution is||
0992|108|P|advised if you have diabetes, liver disease, or any other||
0992|109|P|condition that requires you to limit/avoid these substances in||
0992|110|P|your diet. Ask your doctor or pharmacist about using this product||
0992|111|P|safely.||
0992|112|P|   Children may be more sensitive to the side effects of this||
0992|113|P|drug. This drug can often cause excitement in young children||
0992|114|P|instead of drowsiness.||
0992|115|P|   Older adults may be more sensitive to the side effects of this||
0992|116|P|drug, especially drowsiness, confusion, constipation, trouble||
0992|117|P|urinating or QT prolongation (see above). Drowsiness and||
0992|118|P|confusion can increase the risk of falling.||
0992|119|P|   During pregnancy, this medication should be used only when||
0992|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
0992|121|P|   It is unknown if this drug passes into breast milk. Consult||
0992|122|P|your doctor before breastfeeding.||
0992|123|B|||
0992|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0992|125|I|medications work or increase your risk for serious side effects.||
0992|126|I|This document does not contain all possible drug interactions.||
0992|127|I|Keep a list of all the products you use (including||
0992|128|I|prescription/nonprescription drugs and herbal products) and share||
0992|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
0992|130|I|the dosage of any medicines without your doctor's approval.||
0992|131|I|   Tell your doctor or pharmacist if you are taking other||
0992|132|I|products that cause drowsiness such as opioid pain or cough||
0992|133|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0992|134|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0992|135|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0992|136|I|cyclobenzaprine), or other antihistamines (such as||
0992|137|I|diphenhydramine, promethazine).||
0992|138|I|   Check the labels on all your medicines (such as allergy or||
0992|139|I|cough-and-cold products) because they may contain ingredients||
0992|140|I|that cause drowsiness. Ask your pharmacist about using those||
0992|141|I|products safely.||
0992|142|I|   Do not use with any other antihistamines applied to the skin||
0992|143|I|(such as diphenhydramine cream, ointment, spray) because||
0992|144|I|increased side effects may occur.||
0992|145|I|   Hydroxyzine is very similar to cetirizine and levocetirizine.||
0992|146|I|Do not use these medications while using hydroxyzine.||
0992|147|I|   This medication may interfere with certain lab tests (such as||
0992|148|I|allergy skin testing, urine corticosteroids level), possibly||
0992|149|I|causing false test results. Make sure lab personnel and all your||
0992|150|I|doctors know you use this drug.||
0992|151|B|||
0992|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0992|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0992|154|O|poison control center right away. US residents can call||
0992|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0992|156|O|Symptoms of overdose may include: severe drowsiness, seizures. In||
0992|157|O|children, mental/mood changes (such as restlessness,||
0992|158|O|irritability) may occur before drowsiness.||
0992|159|B|||
0992|160|N|NOTES:  Do not share this medication with others.||
0992|161|B|||
0992|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0992|163|D|remember. If it is near the time of the next dose, skip the||
0992|164|D|missed dose. Take your next dose at the regular time. Do not||
0992|165|D|double the dose to catch up.||
0992|166|B|||
0992|167|R|STORAGE:  Store at room temperature away from light and moisture.||
0992|168|R|Do not store in the bathroom. Do not freeze liquid forms of this||
0992|169|R|medication. Keep all medications away from children and pets.||
0992|170|R|   Do not flush medications down the toilet or pour them into a||
0992|171|R|drain unless instructed to do so. Properly discard this product||
0992|172|R|when it is expired or no longer needed. Consult your pharmacist||
0992|173|R|or local waste disposal company.||
0992|174|B|||
0992|175|A|Information last revised October 2024.||
0992|176|A|Copyright(c) 2025 First Databank, Inc.||
0992|177|B|||
0993|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0993|002|Z|does NOT have all possible information about this product. This||
0993|003|Z|information does not assure that this product is safe, effective,||
0993|004|Z|or appropriate for you. This information is not individual||
0993|005|Z|medical advice and does not substitute for the advice of your||
0993|006|Z|health care professional. Always ask your health care||
0993|007|Z|professional for complete information about this product and your||
0993|008|Z|specific health needs.||
0993|009|B|||
0993|010|T|HYDROXYZINE PAMOATE - ORAL||
0993|011|F|(hye-DROX-i-zeen PAM-oh-ate)||
0993|012|B|||
0993|013|C|COMMON BRAND NAME(S): Vistaril||
0993|014|B|||
0993|015|U|USES:  Hydroxyzine is used to treat itching caused by allergies.||
0993|016|U|It is an antihistamine and works by blocking a certain natural||
0993|017|U|substance (histamine) that your body makes during an allergic||
0993|018|U|reaction. Hydroxyzine may also be used short-term to treat||
0993|019|U|anxiety or to help you feel sleepy/relaxed before and after||
0993|020|U|surgery.||
0993|021|B|||
0993|022|H|HOW TO USE:  Take this medication by mouth with or without food||
0993|023|H|as directed by your doctor, usually three or four times daily.||
0993|024|H|   The dosage is based on your age, medical condition, and||
0993|025|H|response to treatment. Children's dosage may also be based on||
0993|026|H|weight. Do not increase your dose or take this medication more||
0993|027|H|often than directed.||
0993|028|H|   Tell your doctor if your condition does not get better or if||
0993|029|H|it gets worse.||
0993|030|B|||
0993|031|S|SIDE EFFECTS:  Drowsiness, dizziness, blurred vision,||
0993|032|S|constipation, or dry mouth may occur. If any of these effects||
0993|033|S|last or get worse, tell your doctor or pharmacist promptly.||
0993|034|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
0993|035|S|chips, chew (sugarless) gum, drink water, or use a saliva||
0993|036|S|substitute.||
0993|037|S|   Remember that this medication has been prescribed because your||
0993|038|S|doctor has judged that the benefit to you is greater than the||
0993|039|S|risk of side effects. Many people using this medication do not||
0993|040|S|have serious side effects.||
0993|041|S|   Tell your doctor right away if you have any serious side||
0993|042|S|effects, including: mental/mood changes (such as restlessness,||
0993|043|S|confusion, hallucinations), shaking (tremor), difficulty||
0993|044|S|urinating.||
0993|045|S|   Get medical help right away if you have any very serious side||
0993|046|S|effects, including: seizures, fast/irregular heartbeat, severe||
0993|047|S|dizziness, fainting.||
0993|048|S|   A very serious allergic reaction to this drug is rare.||
0993|049|S|However, get medical help right away if you notice any symptoms||
0993|050|S|of a serious allergic reaction, including: rash, itching/swelling||
0993|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0993|052|S|breathing.||
0993|053|S|   This is not a complete list of possible side effects. If you||
0993|054|S|notice other effects not listed above, contact your doctor or||
0993|055|S|pharmacist.||
0993|056|S|   In the US -||
0993|057|S|   Call your doctor for medical advice about side effects. You||
0993|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0993|059|S|www.fda.gov/medwatch.||
0993|060|S|   In Canada - Call your doctor for medical advice about side||
0993|061|S|effects. You may report side effects to Health Canada at||
0993|062|S|1-866-234-2345.||
0993|063|B|||
0993|064|P|PRECAUTIONS:  Before taking hydroxyzine, tell your doctor or||
0993|065|P|pharmacist if you are allergic to it; or to cetirizine; or to||
0993|066|P|levocetirizine; or if you have any other allergies. This product||
0993|067|P|may contain inactive ingredients, which can cause allergic||
0993|068|P|reactions or other problems. Talk to your pharmacist for more||
0993|069|P|details.||
0993|070|P|   Before using this medication, tell your doctor or pharmacist||
0993|071|P|your medical history, especially of: breathing problems (such as||
0993|072|P|emphysema, asthma), high pressure in the eye (glaucoma), high||
0993|073|P|blood pressure, kidney problems, liver problems, seizures,||
0993|074|P|stomach/intestine problems (such as ulcer, blockage), overactive||
0993|075|P|thyroid (hyperthyroidism), difficulty urinating (for example, due||
0993|076|P|to enlarged prostate).||
0993|077|P|   Hydroxyzine may cause a condition that affects the heart||
0993|078|P|rhythm (QT prolongation). QT prolongation can rarely cause||
0993|079|P|serious (rarely fatal) fast/irregular heartbeat and other||
0993|080|P|symptoms (such as severe dizziness, fainting) that need medical||
0993|081|P|attention right away.||
0993|082|P|   The risk of QT prolongation may be increased if you have||
0993|083|P|certain medical conditions or are taking other drugs that may||
0993|084|P|cause QT prolongation. Before taking hydroxyzine, tell your||
0993|085|P|doctor or pharmacist of all the drugs you take and if you have||
0993|086|P|any of the following conditions: certain heart problems (heart||
0993|087|P|failure, slow heartbeat, QT prolongation in the EKG), family||
0993|088|P|history of certain heart problems (QT prolongation in the EKG,||
0993|089|P|sudden cardiac death).||
0993|090|P|   Low levels of potassium or magnesium in the blood may also||
0993|091|P|increase your risk of QT prolongation. This risk may increase if||
0993|092|P|you use certain drugs (such as diuretics/"water pills") or if you||
0993|093|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0993|094|P|Talk to your doctor about taking hydroxyzine safely.||
0993|095|P|   This drug may make you dizzy or drowsy or blur your vision.||
0993|096|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
0993|097|P|drowsy. Do not drive, use machinery, or do anything that needs||
0993|098|P|alertness or clear vision until you can do it safely. Avoid||
0993|099|P|alcoholic beverages. Talk to your doctor if you are using||
0993|100|P|marijuana (cannabis).||
0993|101|P|   Before having surgery, tell your doctor or dentist about all||
0993|102|P|the products you use (including prescription drugs,||
0993|103|P|nonprescription drugs, and herbal products).||
0993|104|P|   Children may be more sensitive to the side effects of this||
0993|105|P|drug. This drug can often cause excitement in young children||
0993|106|P|instead of drowsiness.||
0993|107|P|   Older adults may be more sensitive to the side effects of this||
0993|108|P|drug, especially drowsiness, confusion, constipation, trouble||
0993|109|P|urinating or QT prolongation (see above). Drowsiness and||
0993|110|P|confusion can increase the risk of falling.||
0993|111|P|   During pregnancy, this medication should be used only when||
0993|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
0993|113|P|   It is unknown if this drug passes into breast milk. Consult||
0993|114|P|your doctor before breastfeeding.||
0993|115|B|||
0993|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0993|117|I|medications work or increase your risk for serious side effects.||
0993|118|I|This document does not contain all possible drug interactions.||
0993|119|I|Keep a list of all the products you use (including||
0993|120|I|prescription/nonprescription drugs and herbal products) and share||
0993|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
0993|122|I|the dosage of any medicines without your doctor's approval.||
0993|123|I|   Tell your doctor or pharmacist if you are taking other||
0993|124|I|products that cause drowsiness such as opioid pain or cough||
0993|125|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
0993|126|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
0993|127|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
0993|128|I|cyclobenzaprine), or other antihistamines (such as||
0993|129|I|diphenhydramine, promethazine).||
0993|130|I|   Check the labels on all your medicines (such as allergy or||
0993|131|I|cough-and-cold products) because they may contain ingredients||
0993|132|I|that cause drowsiness. Ask your pharmacist about using those||
0993|133|I|products safely.||
0993|134|I|   Do not use with any other antihistamines applied to the skin||
0993|135|I|(such as diphenhydramine cream, ointment, spray) because||
0993|136|I|increased side effects may occur.||
0993|137|I|   Hydroxyzine is very similar to cetirizine and levocetirizine.||
0993|138|I|Do not use these medications while using hydroxyzine.||
0993|139|I|   This medication may interfere with certain lab tests (such as||
0993|140|I|allergy skin testing, urine corticosteroids level), possibly||
0993|141|I|causing false test results. Make sure lab personnel and all your||
0993|142|I|doctors know you use this drug.||
0993|143|B|||
0993|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0993|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0993|146|O|poison control center right away. US residents can call||
0993|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0993|148|O|Symptoms of overdose may include: severe drowsiness, seizures. In||
0993|149|O|children, mental/mood changes (such as restlessness,||
0993|150|O|irritability) may occur before drowsiness.||
0993|151|B|||
0993|152|N|NOTES:  Do not share this medication with others.||
0993|153|B|||
0993|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
0993|155|D|remember. If it is near the time of the next dose, skip the||
0993|156|D|missed dose. Take your next dose at the regular time. Do not||
0993|157|D|double the dose to catch up.||
0993|158|B|||
0993|159|R|STORAGE:  Store at room temperature away from light and moisture.||
0993|160|R|Do not store in the bathroom. Keep all medications away from||
0993|161|R|children and pets.||
0993|162|R|   Do not flush medications down the toilet or pour them into a||
0993|163|R|drain unless instructed to do so. Properly discard this product||
0993|164|R|when it is expired or no longer needed. Consult your pharmacist||
0993|165|R|or local waste disposal company.||
0993|166|B|||
0993|167|A|Information last revised October 2024.||
0993|168|A|Copyright(c) 2025 First Databank, Inc.||
0993|169|B|||
0994|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0994|002|Z|does NOT have all possible information about this product. This||
0994|003|Z|information does not assure that this product is safe, effective,||
0994|004|Z|or appropriate for you. This information is not individual||
0994|005|Z|medical advice and does not substitute for the advice of your||
0994|006|Z|health care professional. Always ask your health care||
0994|007|Z|professional for complete information about this product and your||
0994|008|Z|specific health needs.||
0994|009|B|||
0994|010|T|RANIBIZUMAB - INTRAOCULAR||
0994|011|F|(ra-ni-BIZ-oo-mab)||
0994|012|B|||
0994|013|C|COMMON BRAND NAME(S): Byooviz, Cimerli, Lucentis||
0994|014|B|||
0994|015|U|USES:  This medication is used to treat certain serious eye||
0994|016|U|conditions (such as age-related macular degeneration, macular||
0994|017|U|edema, diabetic retinopathy). It is used to help prevent||
0994|018|U|decreased vision and blindness. Ranibizumab works by slowing the||
0994|019|U|growth of abnormal new blood vessels in the eye and decreasing||
0994|020|U|leakage from these blood vessels.||
0994|021|U|   This monograph is about the following ranibizumab products:||
0994|022|U|ranibizumab, ranibizumab-eqrn, and ranibizumab-nuna.||
0994|023|B|||
0994|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
0994|025|H|from your pharmacist before you start receiving ranibizumab and||
0994|026|H|each time you get a refill. If you have any questions, ask your||
0994|027|H|doctor or pharmacist.||
0994|028|H|   This medication is given by injection into the affected eye(s)||
0994|029|H|by a health care professional. The affected eye is numbed before||
0994|030|H|each injection. Your eye will be monitored before the injection.||
0994|031|H|After the injection, you will remain in the doctor's office for a||
0994|032|H|while, and your eye will continue to be monitored.||
0994|033|H|   The dosage is based on your medical condition and response to||
0994|034|H|treatment. This medication is given as directed by your doctor,||
0994|035|H|usually once a month for most conditions.||
0994|036|H|   When treating age-related macular degeneration, if you are not||
0994|037|H|able to have monthly injections after your first few doses,||
0994|038|H|getting injections once every 2 or 3 months may be an option,||
0994|039|H|although not as effective as monthly injections. Consult your||
0994|040|H|doctor for more details.||
0994|041|H|   Use this medication regularly to get the most benefit from it.||
0994|042|H|   Tell your doctor if your condition does not get better or if||
0994|043|H|it gets worse.||
0994|044|B|||
0994|045|S|SIDE EFFECTS:  Mild discomfort or increased tears may occur in||
0994|046|S|the affected eye(s). If either of these effects lasts or gets||
0994|047|S|worse, tell your doctor or pharmacist promptly.||
0994|048|S|   Remember that this medication has been prescribed because your||
0994|049|S|doctor has judged that the benefit to you is greater than the||
0994|050|S|risk of side effects. Many people using this medication do not||
0994|051|S|have serious side effects.||
0994|052|S|   This medication may rarely increase your risk for developing||
0994|053|S|certain serious eye conditions (endophthalmitis, retinal||
0994|054|S|detachment, retinal vasculitis). Tell your doctor right away if||
0994|055|S|you notice any of these symptoms in the affected eye(s): pain,||
0994|056|S|redness, sensitivity to light, sudden change in vision.||
0994|057|S|   This medication may sometimes increase the risk of serious||
0994|058|S|(possibly fatal) blood clots. This may lead to stroke, heart||
0994|059|S|attack, and other blood vessel problems. Get medical help right||
0994|060|S|away if you develop: symptoms of stroke (such as weakness on one||
0994|061|S|side of the body, trouble speaking, sudden vision changes,||
0994|062|S|confusion), symptoms of a heart attack (such as chest/jaw/left||
0994|063|S|arm pain).||
0994|064|S|   A very serious allergic reaction to this drug is rare.||
0994|065|S|However, get medical help right away if you notice any symptoms||
0994|066|S|of a serious allergic reaction, including: rash, itching/swelling||
0994|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0994|068|S|breathing.||
0994|069|S|   This is not a complete list of possible side effects. If you||
0994|070|S|notice other effects not listed above, contact your doctor or||
0994|071|S|pharmacist.||
0994|072|S|   In the US -||
0994|073|S|   Call your doctor for medical advice about side effects. You||
0994|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0994|075|S|www.fda.gov/medwatch.||
0994|076|S|   In Canada - Call your doctor for medical advice about side||
0994|077|S|effects. You may report side effects to Health Canada at||
0994|078|S|1-866-234-2345.||
0994|079|B|||
0994|080|P|PRECAUTIONS:  Before receiving ranibizumab, tell your doctor or||
0994|081|P|pharmacist if you are allergic to it; or to other ranibizumab||
0994|082|P|products; or if you have any other allergies. This product may||
0994|083|P|contain inactive ingredients, which can cause allergic reactions||
0994|084|P|or other problems. Talk to your pharmacist for more details.||
0994|085|P|   Before using this medication, tell your doctor or pharmacist||
0994|086|P|your medical history, especially of: a current eye infection,||
0994|087|P|stroke.||
0994|088|P|   Before having surgery, tell your doctor or dentist about all||
0994|089|P|the products you use (including prescription drugs,||
0994|090|P|nonprescription drugs, and herbal products).||
0994|091|P|   This drug may cause blurred vision. Do not drive, use||
0994|092|P|machinery, or do anything that needs clear vision until you can||
0994|093|P|do it safely.||
0994|094|P|   During pregnancy, this medication should be used only when||
0994|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
0994|096|P|   It is unknown if this drug passes into breast milk. However,||
0994|097|P|this medication is unlikely to pass into breast milk. Consult||
0994|098|P|your doctor before breastfeeding.||
0994|099|B|||
0994|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0994|101|I|medications work or increase your risk for serious side effects.||
0994|102|I|This document does not contain all possible drug interactions.||
0994|103|I|Keep a list of all the products you use (including||
0994|104|I|prescription/nonprescription drugs and herbal products) and share||
0994|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
0994|106|I|the dosage of any medicines without your doctor's approval.||
0994|107|B|||
0994|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
0994|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
0994|110|O|poison control center right away. US residents can call||
0994|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
0994|112|B|||
0994|113|N|NOTES:  Medical tests (such as eye exams) should be done while||
0994|114|N|you are using this medication. Keep all medical appointments.||
0994|115|N|Consult your doctor for more details.||
0994|116|B|||
0994|117|D|MISSED DOSE:  It is important to get each dose of this medication||
0994|118|D|as scheduled. If you miss a dose, ask your doctor right away for||
0994|119|D|a new dosing schedule.||
0994|120|B|||
0994|121|R|STORAGE:  Not applicable. This medication is given in a clinic or||
0994|122|R|doctor's office and will not be stored at home.||
0994|123|B|||
0994|124|A|Information last revised October 2024.||
0994|125|A|Copyright(c) 2025 First Databank, Inc.||
0994|126|B|||
0997|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0997|002|Z|does NOT have all possible information about this product. This||
0997|003|Z|information does not assure that this product is safe, effective,||
0997|004|Z|or appropriate for you. This information is not individual||
0997|005|Z|medical advice and does not substitute for the advice of your||
0997|006|Z|health care professional. Always ask your health care||
0997|007|Z|professional for complete information about this product and your||
0997|008|Z|specific health needs.||
0997|009|B|||
0997|010|T|HYALURONATE - TOPICAL||
0997|011|F|(hi-uh-LYOU-ron-ate)||
0997|012|B|||
0997|013|C|COMMON BRAND NAME(S): Bionect||
0997|014|B|||
0997|015|U|USES:  This medication is used to protect skin ulcers, burns, or||
0997|016|U|wounds from irritation so that the skin can heal properly. Some||
0997|017|U|products are also used to help relieve itching and pain from||
0997|018|U|various skin conditions. Hyaluronate is the same as a natural||
0997|019|U|substance that is found in your body. It works by forming a||
0997|020|U|protective layer over the affected area.||
0997|021|B|||
0997|022|H|HOW TO USE:  Use this product on the skin only. If your product||
0997|023|H|is applied with your hands, wash your hands before and after each||
0997|024|H|use. Before using, clean the affected area as directed by your||
0997|025|H|doctor. Gently apply a thin layer of the medication to the||
0997|026|H|affected area(s) of skin as directed by your doctor, usually 2 to||
0997|027|H|3 times daily.||
0997|028|H|   If your product is a liquid suspension, shake the container||
0997|029|H|well before each use.||
0997|030|H|   How often you apply the medication is based on your medical||
0997|031|H|condition and response to treatment.||
0997|032|H|   Use this medication regularly to get the most benefit from it.||
0997|033|H|To help you remember, use it at the same times each day.||
0997|034|H|   Tell your doctor if your condition does not get better or if||
0997|035|H|it gets worse.||
0997|036|B|||
0997|037|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
0997|038|S|because your doctor has judged that the benefit to you is greater||
0997|039|S|than the risk of side effects. Many people using this medication||
0997|040|S|do not have serious side effects.||
0997|041|S|   A very serious allergic reaction to this drug is rare.||
0997|042|S|However, get medical help right away if you notice any symptoms||
0997|043|S|of a serious allergic reaction, including: rash, itching/swelling||
0997|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0997|045|S|breathing.||
0997|046|S|   This is not a complete list of possible side effects. If you||
0997|047|S|notice other effects not listed above, contact your doctor or||
0997|048|S|pharmacist.||
0997|049|S|   In the US -||
0997|050|S|   Call your doctor for medical advice about side effects. You||
0997|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0997|052|S|www.fda.gov/medwatch.||
0997|053|S|   In Canada - Call your doctor for medical advice about side||
0997|054|S|effects. You may report side effects to Health Canada at||
0997|055|S|1-866-234-2345.||
0997|056|B|||
0997|057|P|PRECAUTIONS:  Before using hyaluronate, tell your doctor or||
0997|058|P|pharmacist if you are allergic to it; or if you have any other||
0997|059|P|allergies. This product may contain inactive ingredients, which||
0997|060|P|can cause allergic reactions or other problems. Talk to your||
0997|061|P|pharmacist for more details.||
0997|062|P|   Before using this medication, tell your doctor or pharmacist||
0997|063|P|your medical history.||
0997|064|P|   If you are going to have an MRI test, tell testing personnel||
0997|065|P|that you are using this product. Some brands of this medication||
0997|066|P|may contain metals that can cause serious burns during an MRI and||
0997|067|P|should not be used before MRI imaging. Ask your doctor or||
0997|068|P|pharmacist for questions about your particular brand.||
0997|069|P|   During pregnancy, this medication should be used only when||
0997|070|P|clearly needed. Discuss the risks and benefits with your doctor.||
0997|071|P|   It is unknown if this drug passes into breast milk. Consult||
0997|072|P|your doctor before breastfeeding.||
0997|073|B|||
0997|074|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0997|075|I|medications work or increase your risk for serious side effects.||
0997|076|I|This document does not contain all possible drug interactions.||
0997|077|I|Keep a list of all the products you use (including||
0997|078|I|prescription/nonprescription drugs and herbal products) and share||
0997|079|I|it with your doctor and pharmacist. Do not start, stop, or change||
0997|080|I|the dosage of any medicines without your doctor's approval.||
0997|081|I|   Some products that may interact with this drug are: certain||
0997|082|I|disinfectants (such as benzalkonium chloride).||
0997|083|B|||
0997|084|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0997|085|O|has overdosed and has serious symptoms such as passing out or||
0997|086|O|trouble breathing, call 911. Otherwise, call a poison control||
0997|087|O|center right away. US residents can call 1-800-222-1222. Canada||
0997|088|O|residents can call 1-844-764-7669.||
0997|089|B|||
0997|090|N|NOTES:  Do not share this medication with others. Doing so may||
0997|091|N|spread infection.||
0997|092|N|   This medication has been prescribed for your current condition||
0997|093|N|only. Do not use it later for another skin condition unless told||
0997|094|N|to do so by your doctor.||
0997|095|N|   Some brands of this medication may also contain other||
0997|096|N|ingredients (such as aloe vera, allantoin) which may help provide||
0997|097|N|moisture or soothe the affected area(s). Ask your doctor or||
0997|098|N|pharmacist if you have any questions.||
0997|099|B|||
0997|100|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
0997|101|D|If it is near the time of the next dose, skip the missed dose.||
0997|102|D|Use your next dose at the regular time. Do not double the dose to||
0997|103|D|catch up.||
0997|104|B|||
0997|105|R|STORAGE:  Store at room temperature. Keep all medications away||
0997|106|R|from children and pets.||
0997|107|R|   Do not flush medications down the toilet or pour them into a||
0997|108|R|drain unless instructed to do so. Properly discard this product||
0997|109|R|when it is expired or no longer needed. Consult your pharmacist||
0997|110|R|or local waste disposal company.||
0997|111|B|||
0997|112|A|Information last revised May 2024.||
0997|113|A|Copyright(c) 2025 First Databank, Inc.||
0997|114|B|||
0998|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
0998|002|Z|does NOT have all possible information about this product. This||
0998|003|Z|information does not assure that this product is safe, effective,||
0998|004|Z|or appropriate for you. This information is not individual||
0998|005|Z|medical advice and does not substitute for the advice of your||
0998|006|Z|health care professional. Always ask your health care||
0998|007|Z|professional for complete information about this product and your||
0998|008|Z|specific health needs.||
0998|009|B|||
0998|010|T|FORMOTEROL SOLUTION - INHALATION||
0998|011|F|(for-MOW-ter-all)||
0998|012|B|||
0998|013|C|COMMON BRAND NAME(S): Perforomist||
0998|014|B|||
0998|015|U|USES:  Formoterol is used as a long-term (maintenance) treatment||
0998|016|U|to prevent or decrease breathing problems caused by ongoing lung||
0998|017|U|diseases (chronic obstructive pulmonary disease-COPD, including||
0998|018|U|chronic bronchitis and emphysema). Formoterol belongs to the||
0998|019|U|class of drugs known as long-acting inhaled beta-agonists||
0998|020|U|(LABAs). It works by relaxing the muscles around the airways so||
0998|021|U|that they open up and you can breathe more easily. This effect||
0998|022|U|helps to reduce wheezing, coughing, and shortness of breath.||
0998|023|U|   This medication does not work right away and should not be||
0998|024|U|used for sudden attacks of breathing trouble. Your doctor must||
0998|025|U|prescribe a quick-relief inhaler (such as albuterol, also called||
0998|026|U|salbutamol in some countries) for sudden shortness of breath||
0998|027|U|while you are using formoterol. You should always have a||
0998|028|U|quick-relief inhaler with you.||
0998|029|U|   This form of formoterol is not approved to treat asthma.||
0998|030|U|People with asthma using long-acting inhaled beta agonists (such||
0998|031|U|as formoterol) without also using an inhaled corticosteroid may||
0998|032|U|have an increased risk of serious (sometimes fatal) breathing||
0998|033|U|problems.||
0998|034|B|||
0998|035|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
0998|036|H|your pharmacist before you start using this medication and each||
0998|037|H|time you get a refill. This medication is used with a special||
0998|038|H|machine called a nebulizer that changes the solution to a fine||
0998|039|H|mist that you inhale. Learn all instructions for the use of this||
0998|040|H|medication and the nebulizer equipment. Do not use the solution||
0998|041|H|if it is discolored. If you have any questions, ask your doctor||
0998|042|H|or pharmacist.||
0998|043|H|   This medication does not require any mixing before use. Using||
0998|044|H|a mouthpiece or face mask with the nebulizer, inhale the||
0998|045|H|prescribed dose of medication into your lungs as directed by your||
0998|046|H|doctor, usually twice daily (morning and evening). The two doses||
0998|047|H|should be about 12 hours apart. Each treatment usually takes||
0998|048|H|about 9 minutes. Give this medication only through a nebulizer.||
0998|049|H|Do not swallow the solution. Do not mix with other medicines in||
0998|050|H|your nebulizer.||
0998|051|H|   Use this medication regularly to receive the most benefit from||
0998|052|H|it. To help you remember, use it at the same times each day. To||
0998|053|H|prevent infections, clean the nebulizer and mouthpiece/face mask||
0998|054|H|according to the manufacturer's directions.||
0998|055|H|   Do not use more of this medication or use it more often than||
0998|056|H|prescribed because doing so may cause serious side effects. The||
0998|057|H|manufacturer recommends that you do not use more than 2 vials a||
0998|058|H|day.||
0998|059|H|   Do not stop using this medication or change your dose without||
0998|060|H|consulting your doctor. Some conditions may become worse when the||
0998|061|H|drug is suddenly stopped. Your dose may need to be gradually||
0998|062|H|decreased.||
0998|063|H|   If you have been using a quick-relief inhaler (such as||
0998|064|H|albuterol, salbutamol) on a regular daily schedule (such as 4||
0998|065|H|times daily), your doctor will direct you to stop this schedule||
0998|066|H|and use the quick-relief inhaler only as needed for sudden||
0998|067|H|shortness of breath. Consult your doctor for details.||
0998|068|H|   Learn which of your medications/inhalers you should use every||
0998|069|H|day and which you should use if your breathing suddenly worsens||
0998|070|H|(quick-relief drugs). Ask your doctor ahead of time what you||
0998|071|H|should do if you have new or worsening cough or shortness of||
0998|072|H|breath, wheezing, increased sputum, waking up at night with||
0998|073|H|trouble breathing, if you use your quick-relief inhaler more||
0998|074|H|often, or if your quick-relief inhaler does not seem to be||
0998|075|H|working well. Learn when you can treat sudden breathing problems||
0998|076|H|by yourself and when you must get medical help right away.||
0998|077|H|   Tell your doctor if your symptoms do not get better or if they||
0998|078|H|get worse.||
0998|079|B|||
0998|080|S|SIDE EFFECTS:  Shakiness (tremor), nausea, headache, nervousness,||
0998|081|S|dizziness, dry mouth, or trouble sleeping may occur. If any of||
0998|082|S|these effects last or get worse, tell your doctor or pharmacist||
0998|083|S|promptly.||
0998|084|S|   Remember that this medication has been prescribed because your||
0998|085|S|doctor has judged that the benefit to you is greater than the||
0998|086|S|risk of side effects. Many people using this medication do not||
0998|087|S|have serious side effects.||
0998|088|S|   This medication may raise your blood pressure. Check your||
0998|089|S|blood pressure regularly and tell your doctor if the results are||
0998|090|S|high.||
0998|091|S|   Tell your doctor right away if you have any serious side||
0998|092|S|effects, including: muscle weakness/cramps, increased||
0998|093|S|thirst/urination.||
0998|094|S|   Get medical help right away if you have any very serious side||
0998|095|S|effects, including: chest pain, severe dizziness, fainting,||
0998|096|S|fast/irregular heartbeat.||
0998|097|S|   Rarely, this medication has caused severe (possibly fatal),||
0998|098|S|sudden worsening of breathing problems (paradoxical||
0998|099|S|bronchospasm). If you have trouble breathing or experience sudden||
0998|100|S|wheezing, use your quick-relief inhaler and get medical help||
0998|101|S|right away.||
0998|102|S|   A very serious allergic reaction to this drug is rare.||
0998|103|S|However, get medical help right away if you notice any symptoms||
0998|104|S|of a serious allergic reaction, including: rash, itching/swelling||
0998|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
0998|106|S|breathing.||
0998|107|S|   This is not a complete list of possible side effects. If you||
0998|108|S|notice other effects not listed above, contact your doctor or||
0998|109|S|pharmacist.||
0998|110|S|   In the US -||
0998|111|S|   Call your doctor for medical advice about side effects. You||
0998|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
0998|113|S|www.fda.gov/medwatch.||
0998|114|S|   In Canada - Call your doctor for medical advice about side||
0998|115|S|effects. You may report side effects to Health Canada at||
0998|116|S|1-866-234-2345.||
0998|117|B|||
0998|118|P|PRECAUTIONS:  Before using formoterol, tell your doctor or||
0998|119|P|pharmacist if you are allergic to it; or to arformoterol; or if||
0998|120|P|you have any other allergies. This product may contain inactive||
0998|121|P|ingredients, which can cause allergic reactions or other||
0998|122|P|problems. Talk to your pharmacist for more details.||
0998|123|P|   Before using this medication, tell your doctor or pharmacist||
0998|124|P|your medical history, especially of: diabetes, heart problems||
0998|125|P|(such as irregular heartbeat, angina), high blood pressure, liver||
0998|126|P|problems, overactive thyroid (hyperthyroidism), seizures,||
0998|127|P|swelling of an artery (aneurysm), a certain adrenal gland tumor||
0998|128|P|(pheochromocytoma).||
0998|129|P|   Formoterol may cause a condition that affects the heart rhythm||
0998|130|P|(QT prolongation). QT prolongation can rarely cause serious||
0998|131|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
0998|132|P|as severe dizziness, fainting) that need medical attention right||
0998|133|P|away.||
0998|134|P|   The risk of QT prolongation may be increased if you have||
0998|135|P|certain medical conditions or are taking other drugs that may||
0998|136|P|cause QT prolongation. Before using formoterol, tell your doctor||
0998|137|P|or pharmacist of all the drugs you take and if you have any of||
0998|138|P|the following conditions: certain heart problems (heart failure,||
0998|139|P|slow heartbeat, QT prolongation in the EKG), family history of||
0998|140|P|certain heart problems (QT prolongation in the EKG, sudden||
0998|141|P|cardiac death).||
0998|142|P|   Low levels of potassium or magnesium in the blood may also||
0998|143|P|increase your risk of QT prolongation. This risk may increase if||
0998|144|P|you use certain drugs (such as diuretics/"water pills") or if you||
0998|145|P|have conditions such as severe sweating, diarrhea, or vomiting.||
0998|146|P|Talk to your doctor about using formoterol safely.||
0998|147|P|   Before having surgery, tell your doctor or dentist about all||
0998|148|P|the products you use (including prescription drugs,||
0998|149|P|nonprescription drugs, and herbal products).||
0998|150|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
0998|151|P|can make you more dizzy. Do not drive, use machinery, or do||
0998|152|P|anything that needs alertness until you can do it safely. Limit||
0998|153|P|alcoholic beverages. Talk to your doctor if you are using||
0998|154|P|marijuana (cannabis).||
0998|155|P|   Older adults may be more sensitive to the side effects of this||
0998|156|P|drug, especially QT prolongation (see above).||
0998|157|P|   During pregnancy, this medication should be used only when||
0998|158|P|clearly needed. Discuss the risks and benefits with your doctor.||
0998|159|P|   It is unknown if this drug passes into breast milk. Consult||
0998|160|P|your doctor before breastfeeding.||
0998|161|B|||
0998|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
0998|163|I|medications work or increase your risk for serious side effects.||
0998|164|I|This document does not contain all possible drug interactions.||
0998|165|I|Keep a list of all the products you use (including||
0998|166|I|prescription/nonprescription drugs and herbal products) and share||
0998|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
0998|168|I|the dosage of any medicines without your doctor's approval.||
0998|169|I|   Do not use other LABA drugs (such as arformoterol, salmeterol)||
0998|170|I|while using this medication.||
0998|171|B|||
0998|172|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
0998|173|O|has overdosed and has serious symptoms such as passing out or||
0998|174|O|trouble breathing, call 911. Otherwise, call a poison control||
0998|175|O|center right away. US residents can call 1-800-222-1222. Canada||
0998|176|O|residents can call 1-844-764-7669. Symptoms of overdose may||
0998|177|O|include: chest pain, fast/irregular heartbeat, severe dizziness,||
0998|178|O|fainting.||
0998|179|B|||
0998|180|N|NOTES:  Do not share this medication with others.||
0998|181|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
0998|182|N|lung function) may be done while you are using this medication.||
0998|183|N|Keep all medical and lab appointments. Consult your doctor for||
0998|184|N|more details.||
0998|185|N|   Avoid smoking and other factors that make breathing worse.||
0998|186|N|   Ask your doctor or pharmacist whether you should have an||
0998|187|N|annual flu shot.||
0998|188|B|||
0998|189|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
0998|190|D|next dose at the regular time. Do not double the dose to catch||
0998|191|D|up.||
0998|192|B|||
0998|193|R|STORAGE:  Store in the refrigerator away from light. Keep the||
0998|194|R|medication in the protective pouch until ready to use. This||
0998|195|R|medication may also be stored at room temperature if needed. If||
0998|196|R|the medication is stored at room temperature, discard after 3||
0998|197|R|months. Keep all medications away from children and pets.||
0998|198|R|   Do not flush medications down the toilet or pour them into a||
0998|199|R|drain unless instructed to do so. Properly discard this product||
0998|200|R|when it is expired or no longer needed. Consult your pharmacist||
0998|201|R|or local waste disposal company.||
0998|202|B|||
0998|203|M|MEDICAL ALERT:  Your condition can cause complications in a||
0998|204|M|medical emergency. For information about enrolling in MedicAlert,||
0998|205|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
0998|206|B|||
0998|207|A|Information last revised October 2024.||
0998|208|A|Copyright(c) 2025 First Databank, Inc.||
0998|209|B|||
1002|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1002|002|Z|does NOT have all possible information about this product. This||
1002|003|Z|information does not assure that this product is safe, effective,||
1002|004|Z|or appropriate for you. This information is not individual||
1002|005|Z|medical advice and does not substitute for the advice of your||
1002|006|Z|health care professional. Always ask your health care||
1002|007|Z|professional for complete information about this product and your||
1002|008|Z|specific health needs.||
1002|009|B|||
1002|010|T|NELARABINE - INJECTION||
1002|011|F|(nel-AR-a-been)||
1002|012|B|||
1002|013|C|COMMON BRAND NAME(S): Arranon||
1002|014|B|||
1002|015|W|WARNING:  Rarely, serious nervous system problems have occurred||
1002|016|W|with the use of this medication. The risk may be increased if you||
1002|017|W|have previously received chemotherapy injection into the area||
1002|018|W|around the spinal cord (intrathecal) or radiation treatment to||
1002|019|W|the head/spine area. Tell your doctor right away if you notice||
1002|020|W|any symptoms of nervous system problems including: extreme||
1002|021|W|sleepiness, confusion, numbness/tingling in hands/feet, loss of||
1002|022|W|coordination, muscle weakness, or unsteadiness while walking. Get||
1002|023|W|medical help right away if any of the following symptoms occur:||
1002|024|W|inability to move (paralysis), seizure. These symptoms may not go||
1002|025|W|away completely even when treatment with nelarabine is stopped.||
1002|026|W|Consult your doctor for details.||
1002|027|B|||
1002|028|U|USES:  This medication is used to treat certain cancers||
1002|029|U|(leukemia, lymphoma). Nelarabine is a chemotherapy drug that||
1002|030|U|works by slowing or stopping the growth of cancer cells.||
1002|031|B|||
1002|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1002|033|H|from your pharmacist before you start using nelarabine and each||
1002|034|H|time you get a refill. If you have any questions, ask your doctor||
1002|035|H|or pharmacist.||
1002|036|H|   This medication is given by slow injection into a vein,||
1002|037|H|usually by a health care professional. Each treatment period is||
1002|038|H|called a cycle. In adults, it is usually given on days 1, 3, and||
1002|039|H|5 of each treatment cycle or as directed by your doctor. In||
1002|040|H|children, it is usually given daily for 5 days in a row during||
1002|041|H|each treatment cycle or as directed by the doctor.||
1002|042|H|   The dosage is based on your medical condition, age, body size,||
1002|043|H|and response to treatment. Your doctor will check your blood||
1002|044|H|counts to make sure you can receive your next cycle. Keep all||
1002|045|H|medical and lab appointments.||
1002|046|B|||
1002|047|S|SIDE EFFECTS:  See also Warning section.||
1002|048|S|   Headache, nausea, vomiting, loss of appetite, constipation,||
1002|049|S|diarrhea, cough, shortness of breath, dizziness, drowsiness, and||
1002|050|S|tiredness may occur. In some cases, your doctor may prescribe||
1002|051|S|medication to prevent or relieve nausea and vomiting. Eating||
1002|052|S|several small meals, not eating before treatment, or limiting||
1002|053|S|activity may help lessen some of these effects. If any of these||
1002|054|S|effects last or get worse, tell your doctor or pharmacist||
1002|055|S|promptly.||
1002|056|S|   People using this medication may have serious side effects.||
1002|057|S|However, you have been prescribed this drug because your doctor||
1002|058|S|has judged that the benefit to you is greater than the risk of||
1002|059|S|side effects. Careful monitoring by your doctor may decrease your||
1002|060|S|risk.||
1002|061|S|   Tell your doctor right away if you have any serious side||
1002|062|S|effects, including: easy bruising/bleeding, swelling ankles/feet.||
1002|063|S|   This medication can lower the body's ability to fight an||
1002|064|S|infection. Tell your doctor right away if you develop any signs||
1002|065|S|of an infection (such as sore throat that doesn't go away, fever,||
1002|066|S|chills).||
1002|067|S|   Nelarabine sometimes causes side effects due to the rapid||
1002|068|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1002|069|S|risk, your doctor may add a medication and tell you to drink||
1002|070|S|plenty of fluids. Tell your doctor right away if you have||
1002|071|S|symptoms such as: low back/side pain (flank pain), signs of||
1002|072|S|kidney problems (such as painful urination, pink/bloody urine,||
1002|073|S|change in the amount of urine), muscle spasms/weakness.||
1002|074|S|   A very serious allergic reaction to this drug is rare.||
1002|075|S|However, get medical help right away if you notice any symptoms||
1002|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1002|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1002|078|S|breathing.||
1002|079|S|   This is not a complete list of possible side effects. If you||
1002|080|S|notice other effects not listed above, contact your doctor or||
1002|081|S|pharmacist.||
1002|082|S|   In the US -||
1002|083|S|   Call your doctor for medical advice about side effects. You||
1002|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1002|085|S|www.fda.gov/medwatch.||
1002|086|S|   In Canada - Call your doctor for medical advice about side||
1002|087|S|effects. You may report side effects to Health Canada at||
1002|088|S|1-866-234-2345.||
1002|089|B|||
1002|090|P|PRECAUTIONS:  Before using nelarabine, tell your doctor or||
1002|091|P|pharmacist if you are allergic to it; or if you have any other||
1002|092|P|allergies. This product may contain inactive ingredients, which||
1002|093|P|can cause allergic reactions or other problems. Talk to your||
1002|094|P|pharmacist for more details.||
1002|095|P|   Before using this medication, tell your doctor or pharmacist||
1002|096|P|your medical history, especially of: blood/bleeding disorders||
1002|097|P|(such as anemia, low blood cell counts), kidney problems, liver||
1002|098|P|disease, numbness/tingling in hands/feet (peripheral neuropathy),||
1002|099|P|seizure.||
1002|100|P|   Nelarabine can make you more likely to get infections or may||
1002|101|P|make current infections worse. Stay away from anyone who has an||
1002|102|P|infection that may easily spread (such as chickenpox, COVID-19,||
1002|103|P|measles, flu). Talk to your doctor if you have been exposed to an||
1002|104|P|infection or for more details.||
1002|105|P|   Tell your health care professional that you are using||
1002|106|P|nelarabine before having any immunizations/vaccinations. Avoid||
1002|107|P|contact with people who have recently received live vaccines||
1002|108|P|(such as flu vaccine inhaled through the nose).||
1002|109|P|   To lower your risk of getting cut, bruised, or injured, use||
1002|110|P|caution with sharp objects like razors and nail cutters, and||
1002|111|P|avoid activities such as contact sports.||
1002|112|P|   Before having surgery, tell your doctor or dentist about all||
1002|113|P|the products you use (including prescription drugs,||
1002|114|P|nonprescription drugs, and herbal products).||
1002|115|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1002|116|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1002|117|P|machinery, or do anything that needs alertness until you can do||
1002|118|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1002|119|P|are using marijuana (cannabis).||
1002|120|P|   Older adults may be more sensitive to the side effects of this||
1002|121|P|drug, especially nervous system problems (such as||
1002|122|P|numbness/tingling in hands/feet).||
1002|123|P|   Tell your doctor if you are pregnant or plan to become||
1002|124|P|pregnant. You should not become pregnant while using nelarabine.||
1002|125|P|Nelarabine may harm an unborn baby. Your doctor should order a||
1002|126|P|pregnancy test before you start this medication. Women using this||
1002|127|P|medication should ask about reliable forms of birth control||
1002|128|P|during treatment. Men using this medication should use effective||
1002|129|P|barrier protection (such as latex or polyurethane condoms) during||
1002|130|P|treatment and for 3 months after the last dose. If you or your||
1002|131|P|partner become pregnant, talk to your doctor right away about the||
1002|132|P|risks and benefits of this medication.||
1002|133|P|   It is unknown if this drug passes into breast milk. Because of||
1002|134|P|the possible risk to the infant, breastfeeding is not recommended||
1002|135|P|while using this drug. Consult your doctor before breastfeeding.||
1002|136|B|||
1002|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1002|138|I|medications work or increase your risk for serious side effects.||
1002|139|I|This document does not contain all possible drug interactions.||
1002|140|I|Keep a list of all the products you use (including||
1002|141|I|prescription/nonprescription drugs and herbal products) and share||
1002|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
1002|143|I|the dosage of any medicines without your doctor's approval.||
1002|144|I|   Some products that may interact with this drug include: other||
1002|145|I|anti-cancer drugs (especially pentostatin).||
1002|146|I|   Tell your doctor or pharmacist if you are taking other||
1002|147|I|products that cause drowsiness such as opioid pain or cough||
1002|148|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1002|149|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1002|150|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1002|151|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1002|152|I|diphenhydramine).||
1002|153|I|   Check the labels on all your medicines (such as allergy or||
1002|154|I|cough-and-cold products) because they may contain ingredients||
1002|155|I|that cause drowsiness. Ask your pharmacist about using those||
1002|156|I|products safely.||
1002|157|B|||
1002|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1002|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1002|160|O|poison control center right away. US residents can call||
1002|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1002|162|B|||
1002|163|N|NOTES:  Lab and/or medical tests (such as complete blood count)||
1002|164|N|should be done while you are using this medication. Keep all||
1002|165|N|medical and lab appointments. Consult your doctor for more||
1002|166|N|details.||
1002|167|B|||
1002|168|D|MISSED DOSE:  It is important to get each dose of this medication||
1002|169|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1002|170|D|right away for a new dosing schedule. Do not double the dose to||
1002|171|D|catch up.||
1002|172|B|||
1002|173|R|STORAGE:  Not applicable. This medication is given in a clinic||
1002|174|R|and will not be stored at home.||
1002|175|B|||
1002|176|M|MEDICAL ALERT:  Your condition can cause complications in a||
1002|177|M|medical emergency. For information about enrolling in MedicAlert,||
1002|178|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1002|179|B|||
1002|180|A|Information last revised April 2025.||
1002|181|A|Copyright(c) 2025 First Databank, Inc.||
1002|182|B|||
1004|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1004|002|Z|does NOT have all possible information about this product. This||
1004|003|Z|information does not assure that this product is safe, effective,||
1004|004|Z|or appropriate for you. This information is not individual||
1004|005|Z|medical advice and does not substitute for the advice of your||
1004|006|Z|health care professional. Always ask your health care||
1004|007|Z|professional for complete information about this product and your||
1004|008|Z|specific health needs.||
1004|009|B|||
1004|010|T|METHSCOPOLAMINE - ORAL||
1004|011|F|(METH-skoe-POL-a-meen)||
1004|012|B|||
1004|013|C|COMMON BRAND NAME(S): Pamine, Pamine Forte||
1004|014|B|||
1004|015|U|USES:  Methscopolamine is used with other drugs to treat a||
1004|016|U|certain type of stomach/intestinal ulcer (peptic ulcer). This||
1004|017|U|medication may help relieve stomach/abdominal pain. However, it||
1004|018|U|has not been shown to be effective in healing these ulcers,||
1004|019|U|preventing them from returning, or preventing other problems||
1004|020|U|caused by ulcers. Methscopolamine works by decreasing the amount||
1004|021|U|of acid in the stomach. It also slows the natural movements of||
1004|022|U|the gut and relaxes the muscles in the stomach/intestines.||
1004|023|U|Methscopolamine belongs to a class of drugs known as||
1004|024|U|anticholinergics.||
1004|025|B|||
1004|026|H|HOW TO USE:  Take this medication by mouth as directed by your||
1004|027|H|doctor, usually 4 times a day (30 minutes before meals and at||
1004|028|H|bedtime).||
1004|029|H|   Antacids lower the absorption of methscopolamine. Do not take||
1004|030|H|this medication at the same time as antacids. If you are taking||
1004|031|H|an antacid, take it after meals and take methscopolamine before||
1004|032|H|meals.||
1004|033|H|   The dosage is based on your medical condition and response to||
1004|034|H|treatment.||
1004|035|H|   Do not increase your dose or take this drug more often without||
1004|036|H|your doctor's approval. Your condition will not improve any||
1004|037|H|faster and the risk of serious side effects may increase.||
1004|038|H|   Tell your doctor if your condition lasts or gets worse.||
1004|039|B|||
1004|040|S|SIDE EFFECTS:  Drowsiness, dizziness, weakness, blurred vision,||
1004|041|S|dry eyes, dry mouth, constipation, or abdominal bloating may||
1004|042|S|occur. If any of these effects last or get worse, tell your||
1004|043|S|doctor or pharmacist promptly.||
1004|044|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
1004|045|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1004|046|S|substitute. To relieve dry eyes, consult your pharmacist for||
1004|047|S|artificial tears or other eye lubricants.||
1004|048|S|   To prevent constipation, eat dietary fiber, drink enough||
1004|049|S|water, and exercise. You may also need to take a laxative. Ask||
1004|050|S|your pharmacist which type of laxative is right for you.||
1004|051|S|   Remember that this medication has been prescribed because your||
1004|052|S|doctor has judged that the benefit to you is greater than the||
1004|053|S|risk of side effects. Many people using this medication do not||
1004|054|S|have serious side effects.||
1004|055|S|   Tell your doctor right away if you have any serious side||
1004|056|S|effects, including: decreased sweating, dry/hot/flushed skin,||
1004|057|S|fast/irregular heartbeat, mental/mood changes (such as confusion,||
1004|058|S|hallucinations, agitation, nervousness, unusual excitement),||
1004|059|S|difficulty urinating, decreased sexual ability.||
1004|060|S|   Get medical help right away if you have any very serious side||
1004|061|S|effects, including: eye pain/swelling/redness, vision changes||
1004|062|S|(such as seeing rainbows around lights at night).||
1004|063|S|   A very serious allergic reaction to this drug is rare.||
1004|064|S|However, get medical help right away if you notice any symptoms||
1004|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1004|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1004|067|S|breathing.||
1004|068|S|   This is not a complete list of possible side effects. If you||
1004|069|S|notice other effects not listed above, contact your doctor or||
1004|070|S|pharmacist.||
1004|071|S|   In the US -||
1004|072|S|   Call your doctor for medical advice about side effects. You||
1004|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1004|074|S|www.fda.gov/medwatch.||
1004|075|S|   In Canada - Call your doctor for medical advice about side||
1004|076|S|effects. You may report side effects to Health Canada at||
1004|077|S|1-866-234-2345.||
1004|078|B|||
1004|079|P|PRECAUTIONS:  Before taking methscopolamine, tell your doctor or||
1004|080|P|pharmacist if you are allergic to it or to scopolamine; or if you||
1004|081|P|have any other allergies. This product may contain inactive||
1004|082|P|ingredients, which can cause allergic reactions or other||
1004|083|P|problems. Talk to your pharmacist for more details.||
1004|084|P|   Before using this medication, tell your doctor or pharmacist||
1004|085|P|your medical history, especially of: personal or family history||
1004|086|P|of glaucoma (angle-closure type), difficulty urinating (for||
1004|087|P|example, due to enlarged prostate), other stomach/intestinal||
1004|088|P|problems (such as slow gut, blockage, ulcerative colitis,||
1004|089|P|infection, ileostomy/colostomy patients with diarrhea),||
1004|090|P|overactive thyroid, heart problems (such as coronary artery||
1004|091|P|disease, angina, heart failure, fast/irregular heartbeat), high||
1004|092|P|blood pressure, heartburn problems (such as acid reflux, hiatal||
1004|093|P|hernia, esophagus problems), certain nervous system problem||
1004|094|P|(autonomic neuropathy), myasthenia gravis, liver problems, kidney||
1004|095|P|problems.||
1004|096|P|   This drug may make you dizzy or drowsy or blur your vision.||
1004|097|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1004|098|P|drowsy. Do not drive, use machinery, or do anything that needs||
1004|099|P|alertness or clear vision until you can do it safely. Limit||
1004|100|P|alcoholic beverages. Talk to your doctor if you are using||
1004|101|P|marijuana (cannabis).||
1004|102|P|   This medication may make you sweat less, making you more||
1004|103|P|likely to get heat stroke. Avoid doing things that may cause you||
1004|104|P|to overheat, such as hard work or exercise in hot weather, or||
1004|105|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1004|106|P|and dress lightly. If you overheat, quickly look for a place to||
1004|107|P|cool down and rest. Get medical help right away if you have a||
1004|108|P|fever that does not go away, mental/mood changes, headache, or||
1004|109|P|dizziness.||
1004|110|P|   Older adults may be more sensitive to the side effects of this||
1004|111|P|drug, especially drowsiness, confusion, unusual excitement,||
1004|112|P|constipation, and urination problems.||
1004|113|P|   During pregnancy, this medication should be used only when||
1004|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
1004|115|P|   It is unknown if this drug passes into breast milk. Consult||
1004|116|P|your doctor before breastfeeding.||
1004|117|B|||
1004|118|I|DRUG INTERACTIONS:  See also the How to Use section.||
1004|119|I|   Drug interactions may change how your medications work or||
1004|120|I|increase your risk for serious side effects. This document does||
1004|121|I|not contain all possible drug interactions. Keep a list of all||
1004|122|I|the products you use (including prescription/nonprescription||
1004|123|I|drugs and herbal products) and share it with your doctor and||
1004|124|I|pharmacist. Do not start, stop, or change the dosage of any||
1004|125|I|medicines without your doctor's approval.||
1004|126|I|   Some products that may interact with this drug include:||
1004|127|I|potassium tablets/capsules, drugs that are affected by slowed gut||
1004|128|I|movement (such as pramlintide).||
1004|129|I|   Tell your doctor or pharmacist if you are taking other||
1004|130|I|products that cause drowsiness including alcohol, marijuana||
1004|131|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1004|132|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1004|133|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1004|134|I|codeine).||
1004|135|I|   Check the labels on all your medicines (such as allergy or||
1004|136|I|cough-and-cold products, diet aids) because they may contain||
1004|137|I|ingredients that cause drowsiness or a fast heartbeat. Ask your||
1004|138|I|pharmacist about using those products safely.||
1004|139|I|   This medication may interfere with certain lab tests (such as||
1004|140|I|gastric secretion tests), possibly causing false test results.||
1004|141|I|Make sure lab personnel and all your doctors know you use this||
1004|142|I|drug.||
1004|143|B|||
1004|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1004|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1004|146|O|poison control center right away. US residents can call||
1004|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1004|148|O|Symptoms of overdose may include: large pupils, hot/dry skin,||
1004|149|O|fever, severe dizziness, severe thirst, difficulty swallowing,||
1004|150|O|mental/mood changes (such as confusion, unusual excitement),||
1004|151|O|fast/irregular heartbeat, muscle weakness, inability to move||
1004|152|O|(paralysis), slowed breathing, fainting, seizures.||
1004|153|B|||
1004|154|N|NOTES:  Do not share this medication with others.||
1004|155|N|   Lab and/or medical tests (such as blood cell counts, tests for||
1004|156|N|blood in your stools) should be done while you are taking this||
1004|157|N|medication. Keep all medical and lab appointments. Consult your||
1004|158|N|doctor for more details.||
1004|159|B|||
1004|160|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1004|161|D|remember. If it is near the time of the next dose, skip the||
1004|162|D|missed dose. Take your next dose at the regular time. Do not||
1004|163|D|double the dose to catch up.||
1004|164|B|||
1004|165|R|STORAGE:  Store at room temperature away from light and moisture.||
1004|166|R|Do not store in the bathroom. Keep all medications away from||
1004|167|R|children and pets.||
1004|168|R|   Do not flush medications down the toilet or pour them into a||
1004|169|R|drain unless instructed to do so. Properly discard this product||
1004|170|R|when it is expired or no longer needed. Consult your pharmacist||
1004|171|R|or local waste disposal company.||
1004|172|B|||
1004|173|A|Information last revised May 2024.||
1004|174|A|Copyright(c) 2025 First Databank, Inc.||
1004|175|B|||
1005|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1005|002|Z|does NOT have all possible information about this product. This||
1005|003|Z|information does not assure that this product is safe, effective,||
1005|004|Z|or appropriate for you. This information is not individual||
1005|005|Z|medical advice and does not substitute for the advice of your||
1005|006|Z|health care professional. Always ask your health care||
1005|007|Z|professional for complete information about this product and your||
1005|008|Z|specific health needs.||
1005|009|B|||
1005|010|T|LEVOCETIRIZINE - ORAL||
1005|011|F|(lee-voh-seh-TEER-ah-zeen)||
1005|012|B|||
1005|013|C|COMMON BRAND NAME(S): Xyzal||
1005|014|B|||
1005|015|U|USES:  Levocetirizine is an antihistamine used to relieve allergy||
1005|016|U|symptoms such as watery eyes, runny nose, itching eyes/nose, and||
1005|017|U|sneezing. It is also used to relieve itching and hives. It works||
1005|018|U|by blocking a certain natural substance (histamine) that your||
1005|019|U|body makes during an allergic reaction.||
1005|020|U|   Levocetirizine does not prevent hives or prevent/treat a||
1005|021|U|serious allergic reaction (such as anaphylaxis). If your doctor||
1005|022|U|has prescribed epinephrine to treat allergic reactions, always||
1005|023|U|carry your epinephrine injector with you. Do not use||
1005|024|U|levocetirizine in place of your epinephrine.||
1005|025|B|||
1005|026|H|HOW TO USE:  If you are taking the over-the-counter product to||
1005|027|H|self-treat, read and follow all directions on the product package||
1005|028|H|before taking this medication. If you have any questions, consult||
1005|029|H|your pharmacist. If your doctor has prescribed this medication,||
1005|030|H|take it as directed.||
1005|031|H|   This medication is taken by mouth with or without food,||
1005|032|H|usually once daily in the evening.||
1005|033|H|   If you are using the liquid form of this medication, measure||
1005|034|H|the dose carefully using a special measuring device/spoon. Do not||
1005|035|H|use a household spoon because you may not get the correct dose.||
1005|036|H|   The dosage is based on your age, medical condition, and||
1005|037|H|response to treatment. Do not increase your dose or take this||
1005|038|H|medication more often than directed.||
1005|039|H|   If your condition does not get better or if it gets worse, or||
1005|040|H|if you think you may have a serious medical problem, get medical||
1005|041|H|help right away.||
1005|042|B|||
1005|043|S|SIDE EFFECTS:  Drowsiness, tiredness, and dry mouth may occur.||
1005|044|S|Fever or cough may also occur, especially in children. If any of||
1005|045|S|these effects last or get worse, tell your doctor or pharmacist||
1005|046|S|promptly.||
1005|047|S|   If your doctor has directed you to use this medication,||
1005|048|S|remember that your doctor has judged that the benefit to you is||
1005|049|S|greater than the risk of side effects. Many people using this||
1005|050|S|medication do not have serious side effects.||
1005|051|S|   Tell your doctor right away if you have any serious side||
1005|052|S|effects, including: difficulty urinating, weakness.||
1005|053|S|   Rarely, severe itching may occur after stopping the long-term||
1005|054|S|use of this medication (taking the medication for a few months to||
1005|055|S|years). Talk to your doctor about the risks and benefits of this||
1005|056|S|medication, especially if you are using it regularly for a long||
1005|057|S|time. Tell your doctor right away if itching occurs after||
1005|058|S|stopping the medication.||
1005|059|S|   A very serious allergic reaction to this drug is rare.||
1005|060|S|However, get medical help right away if you notice any symptoms||
1005|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1005|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1005|063|S|breathing.||
1005|064|S|   This is not a complete list of possible side effects. If you||
1005|065|S|notice other effects not listed above, contact your doctor or||
1005|066|S|pharmacist.||
1005|067|S|   In the US -||
1005|068|S|   Call your doctor for medical advice about side effects. You||
1005|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1005|070|S|www.fda.gov/medwatch.||
1005|071|S|   In Canada - Call your doctor for medical advice about side||
1005|072|S|effects. You may report side effects to Health Canada at||
1005|073|S|1-866-234-2345.||
1005|074|B|||
1005|075|P|PRECAUTIONS:  Before taking levocetirizine, tell your doctor or||
1005|076|P|pharmacist if you are allergic to it; or to cetirizine; or to||
1005|077|P|hydroxyzine; or if you have any other allergies. This product may||
1005|078|P|contain inactive ingredients, which can cause allergic reactions||
1005|079|P|or other problems. Talk to your pharmacist for more details.||
1005|080|P|   Before using this medication, tell your doctor or pharmacist||
1005|081|P|your medical history, especially of: difficulty urinating (such||
1005|082|P|as due to an enlarged prostate), kidney disease.||
1005|083|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
1005|084|P|can make you more drowsy. Do not drive, use machinery, or do||
1005|085|P|anything that needs alertness until you can do it safely. Avoid||
1005|086|P|alcoholic beverages. Talk to your doctor if you are using||
1005|087|P|marijuana (cannabis).||
1005|088|P|   Liquid products may contain sugar and/or aspartame. Caution is||
1005|089|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
1005|090|P|condition that requires you to limit/avoid these substances in||
1005|091|P|your diet. Ask your doctor or pharmacist about using this||
1005|092|P|medication safely.||
1005|093|P|   Before having surgery, tell your doctor or dentist about all||
1005|094|P|the products you use (including prescription drugs,||
1005|095|P|nonprescription drugs, and herbal products).||
1005|096|P|   During pregnancy, this medication should be used only when||
1005|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
1005|098|P|   This medication passes into breast milk. Consult your doctor||
1005|099|P|before breastfeeding.||
1005|100|B|||
1005|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1005|102|I|medications work or increase your risk for serious side effects.||
1005|103|I|This document does not contain all possible drug interactions.||
1005|104|I|Keep a list of all the products you use (including||
1005|105|I|prescription/nonprescription drugs and herbal products) and share||
1005|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
1005|107|I|the dosage of any medicines without your doctor's approval.||
1005|108|I|   Tell your doctor or pharmacist if you are taking other||
1005|109|I|products that cause drowsiness such as opioid pain or cough||
1005|110|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1005|111|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1005|112|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1005|113|I|cyclobenzaprine), or other antihistamines (such as||
1005|114|I|diphenhydramine, promethazine).||
1005|115|I|   Check the labels on all your medicines (such as allergy or||
1005|116|I|cough-and-cold products) because they may contain ingredients||
1005|117|I|that cause drowsiness. Ask your pharmacist about using those||
1005|118|I|products safely.||
1005|119|I|   Do not use with any other antihistamines applied to the skin||
1005|120|I|(such as diphenhydramine cream, ointment, spray) because||
1005|121|I|increased side effects may occur.||
1005|122|I|   Levocetirizine is very similar to hydroxyzine and cetirizine.||
1005|123|I|Do not use these medications while using levocetirizine.||
1005|124|I|   This medication may interfere with certain lab tests (such as||
1005|125|I|allergy skin testing), possibly causing false test results. Make||
1005|126|I|sure lab personnel and all your doctors know you use this drug.||
1005|127|B|||
1005|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1005|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1005|130|O|poison control center right away. US residents can call||
1005|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1005|132|O|Symptoms of overdose may include: severe drowsiness. In children,||
1005|133|O|mental/mood changes (such as restlessness, agitation) may occur||
1005|134|O|before drowsiness.||
1005|135|B|||
1005|136|N|NOTES:  Keep all medical and lab appointments.||
1005|137|B|||
1005|138|D|MISSED DOSE:  If you are taking this medication on a regular||
1005|139|D|schedule and miss a dose, take it as soon as you remember. If it||
1005|140|D|is near the time of the next dose, skip the missed dose. Take||
1005|141|D|your next dose at the regular time. Do not double the dose to||
1005|142|D|catch up.||
1005|143|B|||
1005|144|R|STORAGE:  Store at room temperature away from light and moisture.||
1005|145|R|Do not store in the bathroom. Keep all medications away from||
1005|146|R|children and pets.||
1005|147|R|   Do not flush medications down the toilet or pour them into a||
1005|148|R|drain unless instructed to do so. Properly discard this product||
1005|149|R|when it is expired or no longer needed. Consult your pharmacist||
1005|150|R|or local waste disposal company.||
1005|151|B|||
1005|152|A|Information last revised May 2025.||
1005|153|A|Copyright(c) 2025 First Databank, Inc.||
1005|154|B|||
1006|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1006|002|Z|does NOT have all possible information about this product. This||
1006|003|Z|information does not assure that this product is safe, effective,||
1006|004|Z|or appropriate for you. This information is not individual||
1006|005|Z|medical advice and does not substitute for the advice of your||
1006|006|Z|health care professional. Always ask your health care||
1006|007|Z|professional for complete information about this product and your||
1006|008|Z|specific health needs.||
1006|009|B|||
1006|010|T|LORAZEPAM - SUBLINGUAL||
1006|011|F|(lor-AYE-zeh-pam)||
1006|012|B|||
1006|013|W|WARNING:  Lorazepam has a risk for abuse and addiction, which can||
1006|014|W|lead to overdose and death. Taking this medication with alcohol||
1006|015|W|or other drugs that can cause drowsiness or breathing problems||
1006|016|W|(especially opioid medications such as codeine, hydrocodone) may||
1006|017|W|cause very serious side effects, including death. To lower your||
1006|018|W|risk, your doctor should have you take the smallest dose of||
1006|019|W|lorazepam that works, and take it for the shortest possible time.||
1006|020|W|Be sure you know how to take lorazepam and what other drugs you||
1006|021|W|should avoid taking with it. See also Drug Interactions section.||
1006|022|W|Get medical help right away if any of these very serious side||
1006|023|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
1006|024|W|severe drowsiness/dizziness, difficulty waking up.||
1006|025|W|   Suddenly stopping this medication may cause serious (possibly||
1006|026|W|fatal) withdrawal, especially if you have used it for a long time||
1006|027|W|or in high doses. To prevent withdrawal, your doctor may lower||
1006|028|W|your dose slowly. Tell your doctor or pharmacist right away if||
1006|029|W|you have any withdrawal symptoms such as headaches, trouble||
1006|030|W|sleeping, restlessness, hallucinations/confusion, depression,||
1006|031|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
1006|032|W|to months.||
1006|033|B|||
1006|034|U|USES:  This medication is used to treat anxiety. Lorazepam||
1006|035|U|belongs to a class of drugs known as benzodiazepines which act on||
1006|036|U|the brain and nerves (central nervous system) to produce a||
1006|037|U|calming effect. This drug works by enhancing the effects of a||
1006|038|U|certain natural chemical in the body (GABA).||
1006|039|B|||
1006|040|V|OTHER USES:  This section contains uses of this drug that are not||
1006|041|V|listed in the approved professional labeling for the drug but||
1006|042|V|that may be prescribed by your health care professional. Use this||
1006|043|V|drug for a condition that is listed in this section only if it||
1006|044|V|has been so prescribed by your health care professional.||
1006|045|V|   If directed by your doctor, this drug may also be used for||
1006|046|V|sleeping trouble (insomnia) or to reduce the symptoms of alcohol||
1006|047|V|withdrawal. It may also be used to reduce the risk of nausea and||
1006|048|V|vomiting due to chemotherapy.||
1006|049|B|||
1006|050|H|HOW TO USE:  See also Warning section.||
1006|051|H|   Do not swallow whole. Place the tablet under the tongue. It||
1006|052|H|will dissolve in about 20 seconds. Wait at least 2 minutes before||
1006|053|H|swallowing to make sure all the drug is absorbed.||
1006|054|H|   The dosage is based on your medical condition, age, and||
1006|055|H|response to treatment. If directed by your doctor, use this||
1006|056|H|medication regularly in order to get the most benefit from it. To||
1006|057|H|help you remember, use it at the same time(s) each day.||
1006|058|H|   Do not suddenly stop using this drug without consulting your||
1006|059|H|doctor. Some conditions may become worse when this drug is||
1006|060|H|abruptly stopped. Your dose may need to be gradually decreased.||
1006|061|H|   When this medication is used for a long time, it may not work||
1006|062|H|as well. Talk with your doctor if this medication stops working||
1006|063|H|well.||
1006|064|H|   Though it helps many people, this medication may sometimes||
1006|065|H|cause addiction. This risk may be higher if you have a substance||
1006|066|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1006|067|H|Take this medication exactly as prescribed to lower the risk of||
1006|068|H|addiction. Ask your doctor or pharmacist for more details.||
1006|069|H|   Tell your doctor if your condition lasts or gets worse.||
1006|070|B|||
1006|071|S|SIDE EFFECTS:  See also Warning section.||
1006|072|S|   Drowsiness, dizziness, loss of coordination, headache, nausea,||
1006|073|S|blurred vision, change in sexual interest/ability, constipation,||
1006|074|S|heartburn, or change in appetite may occur. If any of these||
1006|075|S|effects last or get worse, tell your doctor or pharmacist||
1006|076|S|promptly.||
1006|077|S|   Remember that this medication has been prescribed because your||
1006|078|S|doctor has judged that the benefit to you is greater than the||
1006|079|S|risk of side effects. Many people using this medication do not||
1006|080|S|have serious side effects.||
1006|081|S|   Tell your doctor right away if you have any serious side||
1006|082|S|effects, including: mental/mood changes (such as hallucinations,||
1006|083|S|depression, thoughts of suicide), trouble speaking, vision||
1006|084|S|changes, unusual weakness, trouble walking, memory problems,||
1006|085|S|signs of infection (such as sore throat that doesn't go away,||
1006|086|S|fever, chills).||
1006|087|S|   Get medical help right away if you have any very serious side||
1006|088|S|effects, including: seizures, slow/shallow breathing.||
1006|089|S|   This medication can rarely have the opposite of its usual||
1006|090|S|calming effect. Symptoms of this opposite effect may include||
1006|091|S|agitation, irritability, violent behavior, confusion,||
1006|092|S|restlessness, excitement, and talking more than normal. Tell your||
1006|093|S|doctor right away if you notice any of these effects.||
1006|094|S|   A very serious allergic reaction to this drug is rare.||
1006|095|S|However, get medical help right away if you notice any symptoms||
1006|096|S|of a serious allergic reaction, including: rash, itching/swelling||
1006|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1006|098|S|breathing.||
1006|099|S|   This is not a complete list of possible side effects. If you||
1006|100|S|notice other effects not listed above, contact your doctor or||
1006|101|S|pharmacist.||
1006|102|S|   In the US -||
1006|103|S|   Call your doctor for medical advice about side effects. You||
1006|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1006|105|S|www.fda.gov/medwatch.||
1006|106|S|   In Canada - Call your doctor for medical advice about side||
1006|107|S|effects. You may report side effects to Health Canada at||
1006|108|S|1-866-234-2345.||
1006|109|B|||
1006|110|P|PRECAUTIONS:  Before taking lorazepam, tell your doctor or||
1006|111|P|pharmacist if you are allergic to it; or to other benzodiazepines||
1006|112|P|(such as alprazolam, clonazepam, diazepam); or if you have any||
1006|113|P|other allergies. This product may contain inactive ingredients,||
1006|114|P|which can cause allergic reactions or other problems. Talk to||
1006|115|P|your pharmacist for more details.||
1006|116|P|   Before using this medication, tell your doctor or pharmacist||
1006|117|P|your medical history, especially of: kidney disease, liver||
1006|118|P|disease, glaucoma, lung/breathing problems (such as sleep apnea),||
1006|119|P|mental/mood disorders (such as depression, psychosis), personal||
1006|120|P|or family history of a substance use disorder (such as overuse of||
1006|121|P|or addiction to drugs/alcohol).||
1006|122|P|   This drug may make you dizzy or drowsy or blur your vision.||
1006|123|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1006|124|P|drowsy. Do not drive, use machinery, or do anything that needs||
1006|125|P|alertness or clear vision until you can do it safely. Avoid||
1006|126|P|alcoholic beverages. Talk to your doctor if you are using||
1006|127|P|marijuana (cannabis).||
1006|128|P|   Before having surgery, tell your doctor or dentist about all||
1006|129|P|the products you use (including prescription drugs,||
1006|130|P|nonprescription drugs, and herbal products).||
1006|131|P|   Older adults may be more sensitive to the side effects of this||
1006|132|P|drug, especially loss of coordination and drowsiness. Loss of||
1006|133|P|coordination and drowsiness may increase the risk of falling.||
1006|134|P|Also, lorazepam may have the opposite of its usual calming effect||
1006|135|P|in older adults (see also Side Effects section).||
1006|136|P|   This drug may have the opposite of its usual calming effect in||
1006|137|P|children, causing restlessness, shaking, or mental/mood changes||
1006|138|P|(such as agitation, hallucinations).||
1006|139|P|   Tell your doctor if you are pregnant or plan to become||
1006|140|P|pregnant. You should not become pregnant while using lorazepam.||
1006|141|P|Lorazepam may harm an unborn baby. Newborn babies of mothers who||
1006|142|P|use this medication late in pregnancy may have symptoms such as||
1006|143|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
1006|144|P|feeding. If you become pregnant, talk to your doctor right away||
1006|145|P|about the risks and benefits of this medication.||
1006|146|P|   This drug passes into breast milk. Consult your doctor before||
1006|147|P|breastfeeding.||
1006|148|B|||
1006|149|I|DRUG INTERACTIONS:  See also Warning section.||
1006|150|I|   Drug interactions may change how your medications work or||
1006|151|I|increase your risk for serious side effects. This document does||
1006|152|I|not contain all possible drug interactions. Keep a list of all||
1006|153|I|the products you use (including prescription/nonprescription||
1006|154|I|drugs and herbal products) and share it with your doctor and||
1006|155|I|pharmacist. Do not start, stop, or change the dosage of any||
1006|156|I|medicines without your doctor's approval.||
1006|157|I|   Some products that may interact with this drug include:||
1006|158|I|clozapine, kava, sodium oxybate (also known as gamma||
1006|159|I|hydroxybutyrate or GHB).||
1006|160|I|   The risk of serious side effects (such as slow/shallow||
1006|161|I|breathing, severe drowsiness/dizziness) may be increased if this||
1006|162|I|medication is taken with other products that may also cause||
1006|163|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1006|164|I|if you are taking other products such as opioid pain or cough||
1006|165|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1006|166|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
1006|167|I|diazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1006|168|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1006|169|I|diphenhydramine).||
1006|170|I|   Check the labels on all your medicines (such as allergy or||
1006|171|I|cough-and-cold products) because they may contain ingredients||
1006|172|I|that cause drowsiness. Ask your pharmacist about using those||
1006|173|I|products safely.||
1006|174|B|||
1006|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1006|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1006|177|O|poison control center right away. US residents can call||
1006|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1006|179|O|Symptoms of overdose may include confusion, slow reflexes,||
1006|180|O|clumsiness, deep sleep, and loss of consciousness.||
1006|181|B|||
1006|182|N|NOTES:  Lifestyle changes such as starting a stress reduction||
1006|183|N|program may increase the effectiveness of this medication. Talk||
1006|184|N|to your doctor or pharmacist about lifestyle changes that might||
1006|185|N|benefit you.||
1006|186|N|   Do not share this medication with others. Sharing it is||
1006|187|N|against the law.||
1006|188|N|   Lab and/or medical tests (such as blood counts, liver||
1006|189|N|function) should be done while you are taking this medication.||
1006|190|N|Keep all medical and lab appointments. Consult your doctor for||
1006|191|N|more details.||
1006|192|B|||
1006|193|D|MISSED DOSE:  If you miss a dose and are taking more than 1 dose||
1006|194|D|daily, do not take it if it is almost time for the next dose.||
1006|195|D|Instead, skip the missed dose. Take your next dose at the regular||
1006|196|D|time. Do not double the dose to catch up. If you take it once||
1006|197|D|daily at bedtime and miss a dose, do not take it the following||
1006|198|D|morning. Call your doctor to find out what to do.||
1006|199|B|||
1006|200|R|STORAGE:  Store at room temperature away from light and moisture.||
1006|201|R|Do not store in the bathroom. Keep all medications away from||
1006|202|R|children and pets.||
1006|203|R|   Do not flush medications down the toilet or pour them into a||
1006|204|R|drain unless instructed to do so. Properly discard this product||
1006|205|R|when it is expired or no longer needed. Consult your pharmacist||
1006|206|R|or local waste disposal company.||
1006|207|B|||
1006|208|M|MEDICAL ALERT:  Your condition can cause complications in a||
1006|209|M|medical emergency. For information about enrolling in MedicAlert,||
1006|210|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1006|211|B|||
1006|212|A|Information last revised May 2025.||
1006|213|A|Copyright(c) 2025 First Databank, Inc.||
1006|214|B|||
1007|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1007|002|Z|does NOT have all possible information about this product. This||
1007|003|Z|information does not assure that this product is safe, effective,||
1007|004|Z|or appropriate for you. This information is not individual||
1007|005|Z|medical advice and does not substitute for the advice of your||
1007|006|Z|health care professional. Always ask your health care||
1007|007|Z|professional for complete information about this product and your||
1007|008|Z|specific health needs.||
1007|009|B|||
1007|010|T|BEXAROTENE GEL - TOPICAL||
1007|011|F|(bex-AR-oh-teen)||
1007|012|B|||
1007|013|C|COMMON BRAND NAME(S): Targretin||
1007|014|B|||
1007|015|U|USES:  Bexarotene is used to treat skin problems from a certain||
1007|016|U|type of cancer (cutaneous T-cell lymphoma-CTCL). It works by||
1007|017|U|slowing or stopping the growth of these cancer cells. Bexarotene||
1007|018|U|belongs to a class of drugs called retinoids (drugs related to||
1007|019|U|vitamin A).||
1007|020|B|||
1007|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1007|022|H|from your pharmacist before you start using bexarotene and each||
1007|023|H|time you get a refill. If you have any questions, consult your||
1007|024|H|doctor or pharmacist.||
1007|025|H|   This medication is for use on the skin only. Do not apply this||
1007|026|H|medication into mucous membranes such as the eyes, nose, mouth,||
1007|027|H|lips, vagina, tip of the penis, rectum, or anus. Avoid applying||
1007|028|H|to healthy areas of skin because irritation or redness can occur.||
1007|029|H|   Wash your hands right away with soap and water before and||
1007|030|H|after using this medication. Cover the affected skin area with a||
1007|031|H|generous layer of gel. Allow the gel to dry for 5 to 10 minutes||
1007|032|H|before covering the area with clothing. Apply this medication as||
1007|033|H|directed by your doctor, usually once every other day for the||
1007|034|H|first week, then increased at weekly intervals to once a day,||
1007|035|H|then twice a day, then 3 times a day, and then finally 4 times a||
1007|036|H|day. The dosage is based on your medical condition and response||
1007|037|H|to treatment. If side effects occur, your doctor may direct you||
1007|038|H|to apply this medication less often or temporarily stop use until||
1007|039|H|the side effects lessen.||
1007|040|H|   Do not cover, bandage, or wrap the treated area unless your||
1007|041|H|doctor directs you to do so. Wait at least 20 minutes after||
1007|042|H|showering or bathing before applying this medication. Use a mild||
1007|043|H|soap when washing the skin to reduce irritation. Avoid showering,||
1007|044|H|bathing, or swimming for at least 3 hours after applying this||
1007|045|H|medication.||
1007|046|H|   Use this medication regularly to get the most benefit from it.||
1007|047|H|To help you remember, use it at the same time(s) each day. You||
1007|048|H|may start to see some benefit as early as 4 weeks after starting||
1007|049|H|treatment, but usually you will not get the full benefit until||
1007|050|H|close to a year or more of use. Continue to use this medication||
1007|051|H|and do not stop until your doctor directs you to do so.||
1007|052|H|   Since this drug is absorbed through the skin and may harm an||
1007|053|H|unborn baby, women who are pregnant or who may become pregnant||
1007|054|H|should not handle this medication. Learn proper technique for||
1007|055|H|safe handling and disposal of this medicine and its container.||
1007|056|H|Consult your pharmacist.||
1007|057|B|||
1007|058|S|SIDE EFFECTS:  Pain, redness, irritation, itching, or flaking of||
1007|059|S|the skin may occur at the application site. If any of these||
1007|060|S|effects last or get worse, tell your doctor or pharmacist||
1007|061|S|promptly.||
1007|062|S|   Remember that this medication has been prescribed because your||
1007|063|S|doctor has judged that the benefit to you is greater than the||
1007|064|S|risk of side effects. Many people using this medication do not||
1007|065|S|have serious side effects.||
1007|066|S|   A very serious allergic reaction to this drug is rare.||
1007|067|S|However, get medical help right away if you notice any symptoms||
1007|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1007|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1007|070|S|breathing.||
1007|071|S|   Bexarotene can commonly cause a rash that is usually not||
1007|072|S|serious. However, you may not be able to tell it apart from a||
1007|073|S|rare rash that could be a sign of a severe reaction. Get medical||
1007|074|S|help right away if you develop any rash.||
1007|075|S|   This is not a complete list of possible side effects. If you||
1007|076|S|notice other effects not listed above, contact your doctor or||
1007|077|S|pharmacist.||
1007|078|S|   In the US -||
1007|079|S|   Call your doctor for medical advice about side effects. You||
1007|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1007|081|S|www.fda.gov/medwatch.||
1007|082|S|   In Canada - Call your doctor for medical advice about side||
1007|083|S|effects. You may report side effects to Health Canada at||
1007|084|S|1-866-234-2345.||
1007|085|B|||
1007|086|P|PRECAUTIONS:  Before using bexarotene, tell your doctor or||
1007|087|P|pharmacist if you are allergic to it; or to vitamin A-related||
1007|088|P|drugs (other retinoids such as isotretinoin); or if you have any||
1007|089|P|other allergies. This product may contain inactive ingredients,||
1007|090|P|which can cause allergic reactions or other problems. Talk to||
1007|091|P|your pharmacist for more details.||
1007|092|P|   Before using this medication, tell your doctor or pharmacist||
1007|093|P|your medical history, especially of: kidney problems, liver||
1007|094|P|problems.||
1007|095|P|   This medication may make you more sensitive to the sun. Limit||
1007|096|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1007|097|P|sunscreen and wear protective clothing when outdoors. Tell your||
1007|098|P|doctor right away if you get sunburned or have skin||
1007|099|P|blisters/redness.||
1007|100|P|   This medication must not be used during pregnancy. It may harm||
1007|101|P|an unborn baby. If you become pregnant or think you may be||
1007|102|P|pregnant, tell your doctor right away. To make sure that you are||
1007|103|P|not pregnant, you should have a pregnancy test before you start||
1007|104|P|treatment with bexarotene and every month while you are using||
1007|105|P|this medication. Consult your doctor to discuss reliable forms of||
1007|106|P|birth control. Use 2 effective forms of birth control together||
1007|107|P|(or completely avoid sexual intercourse) for 1 month before||
1007|108|P|treatment starts, during treatment, and for 1 month after you||
1007|109|P|stop treatment. Males using this medication with partners who are||
1007|110|P|pregnant or may become pregnant must use a condom during sexual||
1007|111|P|activity during treatment and for at least 1 month after||
1007|112|P|treatment ends.||
1007|113|P|   Since this drug is absorbed through the skin and may harm an||
1007|114|P|unborn baby, women who are pregnant or who may become pregnant||
1007|115|P|should not handle this medication.||
1007|116|P|   It is unknown if this medication passes into breast milk.||
1007|117|P|Because of the possible risk to the infant, breastfeeding is not||
1007|118|P|recommended while using this medication. Consult your doctor||
1007|119|P|before breastfeeding.||
1007|120|B|||
1007|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1007|122|I|medications work or increase your risk for serious side effects.||
1007|123|I|This document does not contain all possible drug interactions.||
1007|124|I|Keep a list of all the products you use (including||
1007|125|I|prescription/nonprescription drugs and herbal products) and share||
1007|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
1007|127|I|the dosage of any medicines without your doctor's approval.||
1007|128|I|   Some products that may interact with this drug are: insect||
1007|129|I|repellents that contain DEET, vitamins/supplements that contain||
1007|130|I|vitamin A.||
1007|131|B|||
1007|132|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1007|133|O|has overdosed and has serious symptoms such as passing out or||
1007|134|O|trouble breathing, call 911. Otherwise, call a poison control||
1007|135|O|center right away. US residents can call 1-800-222-1222. Canada||
1007|136|O|residents can call 1-844-764-7669.||
1007|137|B|||
1007|138|N|NOTES:  Do not share this medication with others.||
1007|139|B|||
1007|140|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1007|141|D|If it is near the time of the next dose, skip the missed dose.||
1007|142|D|Use your next dose at the regular time. Do not double the dose to||
1007|143|D|catch up.||
1007|144|B|||
1007|145|R|STORAGE:  Store at room temperature. Keep away from heat and open||
1007|146|R|flame. Keep all medications away from children and pets.||
1007|147|R|   Do not flush medications down the toilet or pour them into a||
1007|148|R|drain unless instructed to do so. Properly discard this product||
1007|149|R|when it is expired or no longer needed. Consult your pharmacist||
1007|150|R|or local waste disposal company.||
1007|151|B|||
1007|152|A|Information last revised May 2024.||
1007|153|A|Copyright(c) 2025 First Databank, Inc.||
1007|154|B|||
1009|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1009|002|Z|does NOT have all possible information about this product. This||
1009|003|Z|information does not assure that this product is safe, effective,||
1009|004|Z|or appropriate for you. This information is not individual||
1009|005|Z|medical advice and does not substitute for the advice of your||
1009|006|Z|health care professional. Always ask your health care||
1009|007|Z|professional for complete information about this product and your||
1009|008|Z|specific health needs.||
1009|009|B|||
1009|010|T|SULFACETAMIDE SODIUM CLEANSER - TOPICAL||
1009|011|F|(SUL-fa-SET-a-mide SOE-dee-um)||
1009|012|B|||
1009|013|C|COMMON BRAND NAME(S): Ovace Plus||
1009|014|B|||
1009|015|U|USES:  This medication is used as a skin cleansing product to||
1009|016|U|treat dandruff and other skin conditions (such as seborrheic||
1009|017|U|dermatitis). It is also used to treat certain bacterial skin||
1009|018|U|infections. Sulfacetamide is a sulfonamide antibiotic. It works||
1009|019|U|by stopping the growth of bacteria.||
1009|020|B|||
1009|021|H|HOW TO USE:  This medication is for use on the skin only.||
1009|022|H|   Wash the affected area with this product as directed by your||
1009|023|H|doctor, usually twice daily (morning and evening) for 8 to 10||
1009|024|H|days or. Wet the skin well and apply a generous amount to the||
1009|025|H|affected areas. Gently massage the medication with your fingers||
1009|026|H|into the affected area until a full lather appears. Rinse well||
1009|027|H|with plain water and pat area dry. Avoid getting this medication||
1009|028|H|in the eyes, nose, or mouth, or on the eyelids or lips. If you do||
1009|029|H|get the medication in those areas, wash with plenty of water.||
1009|030|H|   How often you use this medication is based on your medical||
1009|031|H|condition and response to treatment.||
1009|032|H|   At least once a week, wash your hair normally with regular||
1009|033|H|(non-medicated) shampoo.||
1009|034|H|   Use this medication regularly to get the most benefit from it.||
1009|035|H|To help you remember, use it at the same time(s) each day. Do not||
1009|036|H|use more of this medication, use it more often, or keep using it||
1009|037|H|for longer than prescribed. Your skin will not improve any||
1009|038|H|faster, and your risk of side effects may be increased.||
1009|039|H|   If too much dryness occurs, you may need to rinse the cleanser||
1009|040|H|off sooner or use the product less often. Ask your doctor or||
1009|041|H|pharmacist for more details.||
1009|042|H|   As your condition improves, your doctor may direct you to use||
1009|043|H|this product less often to keep your condition under control||
1009|044|H|(once/twice weekly or every other week). Tell your doctor if your||
1009|045|H|condition does not get better or if it gets worse.||
1009|046|B|||
1009|047|S|SIDE EFFECTS:  This medication may cause redness, stinging, or||
1009|048|S|burning of the skin. If any of these effects last or get worse,||
1009|049|S|tell your doctor or pharmacist promptly.||
1009|050|S|   Remember that this medication has been prescribed because your||
1009|051|S|doctor has judged that the benefit to you is greater than the||
1009|052|S|risk of side effects. Many people using this medication do not||
1009|053|S|have serious side effects.||
1009|054|S|   Rarely, serious side effects have occurred with other sulfa||
1009|055|S|antibiotics that are taken by mouth. Although this effect is||
1009|056|S|unlikely with sulfa medications that are applied to the skin,||
1009|057|S|tell your doctor right away if you have any serious side effects,||
1009|058|S|including: joint pain, butterfly-shaped rash around the nose and||
1009|059|S|cheeks, mouth sores, signs of infection (such as sore throat that||
1009|060|S|doesn't go away, fever, chills), unusual weakness/tiredness,||
1009|061|S|unusual bleeding/bruising, dark urine, yellowing eyes/skin.||
1009|062|S|   Use of this medication for prolonged or repeated periods may||
1009|063|S|result in a fungal skin infection. Do not use this medication for||
1009|064|S|longer than prescribed. Contact your doctor if you notice new or||
1009|065|S|worsening symptoms.||
1009|066|S|   A very serious allergic reaction to this drug is rare.||
1009|067|S|However, get medical help right away if you notice any symptoms||
1009|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1009|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1009|070|S|breathing.||
1009|071|S|   This is not a complete list of possible side effects. If you||
1009|072|S|notice other effects not listed above, contact your doctor or||
1009|073|S|pharmacist.||
1009|074|S|   In the US -||
1009|075|S|   Call your doctor for medical advice about side effects. You||
1009|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1009|077|S|www.fda.gov/medwatch.||
1009|078|S|   In Canada - Call your doctor for medical advice about side||
1009|079|S|effects. You may report side effects to Health Canada at||
1009|080|S|1-866-234-2345.||
1009|081|B|||
1009|082|P|PRECAUTIONS:  Before using sulfacetamide, tell your doctor or||
1009|083|P|pharmacist if you are allergic to it; or to other sulfonamides||
1009|084|P|such as sulfamethoxazole; or if you have any other allergies.||
1009|085|P|This product may contain inactive ingredients, which can cause||
1009|086|P|allergic reactions or other problems. Talk to your pharmacist for||
1009|087|P|more details.||
1009|088|P|   Before using this medication, tell your doctor or pharmacist||
1009|089|P|your medical history, especially of: broken/scraped/injured skin||
1009|090|P|in the affected area.||
1009|091|P|   This medication may make you more sensitive to the sun. Limit||
1009|092|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1009|093|P|sunscreen and wear protective clothing when outdoors. Tell your||
1009|094|P|doctor right away if you get sunburned or have skin||
1009|095|P|blisters/redness.||
1009|096|P|   Before having surgery, tell your doctor or dentist about all||
1009|097|P|the products you use (including prescription drugs,||
1009|098|P|nonprescription drugs, and herbal products).||
1009|099|P|   During pregnancy, this medication should be used only when||
1009|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
1009|101|P|   It is unknown if this drug passes into breast milk. Consult||
1009|102|P|your doctor before breastfeeding.||
1009|103|B|||
1009|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1009|105|I|medications work or increase your risk for serious side effects.||
1009|106|I|This document does not contain all possible drug interactions.||
1009|107|I|Keep a list of all the products you use (including||
1009|108|I|prescription/nonprescription drugs and herbal products) and share||
1009|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
1009|110|I|the dosage of any medicines without your doctor's approval.||
1009|111|I|   Some products that may interact with this drug are: products||
1009|112|I|containing silver that are applied to the skin (such as silver||
1009|113|I|sulfadiazine).||
1009|114|B|||
1009|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1009|116|O|has overdosed and has serious symptoms such as passing out or||
1009|117|O|trouble breathing, call 911. Otherwise, call a poison control||
1009|118|O|center right away. US residents can call 1-800-222-1222. Canada||
1009|119|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1009|120|O|include: nausea, vomiting, pink/red urine.||
1009|121|B|||
1009|122|N|NOTES:  Do not share this medication with others.||
1009|123|N|   This product may temporarily stain clothing. The stain will||
1009|124|N|usually wash out with normal cleaning.||
1009|125|B|||
1009|126|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1009|127|D|If it is near the time of the next dose, skip the missed dose.||
1009|128|D|Use your next dose at the regular time. Do not double the dose to||
1009|129|D|catch up.||
1009|130|B|||
1009|131|R|STORAGE:  Store at room temperature. Different brands of this||
1009|132|R|medication may have different storage requirements. Refer to the||
1009|133|R|package labeling or ask your pharmacist for the storage||
1009|134|R|requirements for the brand you are using. Do not freeze. This||
1009|135|R|medication may darken slightly over time. This darkening does not||
1009|136|R|change the effectiveness or safety of the medication. Keep all||
1009|137|R|medications away from children and pets.||
1009|138|R|   Do not flush medications down the toilet or pour them into a||
1009|139|R|drain unless instructed to do so. Properly discard this product||
1009|140|R|when it is expired or no longer needed. Consult your pharmacist||
1009|141|R|or local waste disposal company.||
1009|142|B|||
1009|143|A|Information last revised April 2025.||
1009|144|A|Copyright(c) 2025 First Databank, Inc.||
1009|145|B|||
1010|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1010|002|Z|does NOT have all possible information about this product. This||
1010|003|Z|information does not assure that this product is safe, effective,||
1010|004|Z|or appropriate for you. This information is not individual||
1010|005|Z|medical advice and does not substitute for the advice of your||
1010|006|Z|health care professional. Always ask your health care||
1010|007|Z|professional for complete information about this product and your||
1010|008|Z|specific health needs.||
1010|009|B|||
1010|010|T|VERAPAMIL - ORAL||
1010|011|F|(ver-AP-a-mil)||
1010|012|B|||
1010|013|C|COMMON BRAND NAME(S): Calan, Isoptin||
1010|014|B|||
1010|015|U|USES:  Verapamil is used to treat high blood pressure. Lowering||
1010|016|U|high blood pressure helps prevent strokes, heart attacks, and||
1010|017|U|kidney problems. Verapamil belongs to a class of drugs known as||
1010|018|U|calcium channel blockers. It works by relaxing blood vessels so||
1010|019|U|blood can flow more easily.||
1010|020|U|   Verapamil is also used to prevent chest pain (angina). It may||
1010|021|U|help to increase your ability to exercise and decrease how often||
1010|022|U|you may get angina attacks. Verapamil is also used to control||
1010|023|U|your heart rate if you have a fast/irregular heartbeat (such as||
1010|024|U|atrial fibrillation). It helps to lower the heart rate, helping||
1010|025|U|you to feel more comfortable and increase your ability to||
1010|026|U|exercise.||
1010|027|B|||
1010|028|V|OTHER USES:  This section contains uses of this drug that are not||
1010|029|V|listed in the approved professional labeling for the drug but||
1010|030|V|that may be prescribed by your health care professional. Use this||
1010|031|V|drug for a condition that is listed in this section only if it||
1010|032|V|has been so prescribed by your health care professional.||
1010|033|V|   This drug may also be used for another type of heart disease||
1010|034|V|(hypertrophic cardiomyopathy).||
1010|035|B|||
1010|036|H|HOW TO USE:  Take this medication by mouth with or without food||
1010|037|H|as directed by your doctor, usually 3 or 4 times daily.||
1010|038|H|   The dosage is based on your medical condition and response to||
1010|039|H|treatment.||
1010|040|H|   Use this medication regularly to get the most benefit from it.||
1010|041|H|To help you remember, take it at the same times each day.||
1010|042|H|   For the treatment of high blood pressure, it may take a week||
1010|043|H|before you get the full benefit of this drug. Keep taking this||
1010|044|H|medication even if you feel well. Most people with high blood||
1010|045|H|pressure do not feel sick.||
1010|046|H|   To prevent chest pain, it is very important to take this||
1010|047|H|medication regularly as prescribed. This drug should not be used||
1010|048|H|to treat chest pain when it occurs. Use other medications to||
1010|049|H|relieve sudden attacks as directed by your doctor (for example,||
1010|050|H|nitroglycerin tablets placed under the tongue). Consult your||
1010|051|H|doctor or pharmacist for details.||
1010|052|H|   Do not stop taking this medication without consulting your||
1010|053|H|doctor. Some conditions may become worse when this drug is||
1010|054|H|suddenly stopped. Your dose may need to be gradually decreased.||
1010|055|H|   Tell your doctor if your condition does not get better or if||
1010|056|H|it gets worse (for example, your blood pressure readings remain||
1010|057|H|high or increase, your chest pain occurs more often).||
1010|058|B|||
1010|059|S|SIDE EFFECTS:  Dizziness, slow heartbeat, constipation, nausea,||
1010|060|S|headache, or tiredness may occur. If any of these effects last or||
1010|061|S|get worse, tell your doctor or pharmacist promptly.||
1010|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
1010|063|S|slowly when rising from a sitting or lying position.||
1010|064|S|   Remember that this medication has been prescribed because your||
1010|065|S|doctor has judged that the benefit to you is greater than the||
1010|066|S|risk of side effects. Many people using this medication do not||
1010|067|S|have serious side effects.||
1010|068|S|   Tell your doctor right away if you have any serious side||
1010|069|S|effects, including: severe dizziness, fainting, new or worsening||
1010|070|S|symptoms of heart failure (such as shortness of breath, swelling||
1010|071|S|ankles/feet, unusual tiredness, unusual/sudden weight gain), very||
1010|072|S|slow heartbeat.||
1010|073|S|   This drug may rarely cause serious (possibly fatal) liver||
1010|074|S|disease. Get medical help right away if you have any symptoms of||
1010|075|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
1010|076|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1010|077|S|urine.||
1010|078|S|   A very serious allergic reaction to this drug is rare.||
1010|079|S|However, get medical help right away if you notice any symptoms||
1010|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1010|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1010|082|S|breathing.||
1010|083|S|   This is not a complete list of possible side effects. If you||
1010|084|S|notice other effects not listed above, contact your doctor or||
1010|085|S|pharmacist.||
1010|086|S|   In the US -||
1010|087|S|   Call your doctor for medical advice about side effects. You||
1010|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1010|089|S|www.fda.gov/medwatch.||
1010|090|S|   In Canada - Call your doctor for medical advice about side||
1010|091|S|effects. You may report side effects to Health Canada at||
1010|092|S|1-866-234-2345.||
1010|093|B|||
1010|094|P|PRECAUTIONS:  Before taking verapamil, tell your doctor or||
1010|095|P|pharmacist if you are allergic to it; or if you have any other||
1010|096|P|allergies. This product may contain inactive ingredients, which||
1010|097|P|can cause allergic reactions or other problems. Talk to your||
1010|098|P|pharmacist for more details.||
1010|099|P|   Before using this medication, tell your doctor or pharmacist||
1010|100|P|your medical history, especially of: certain types of heart||
1010|101|P|rhythm problems (such as second- or third-degree atrioventricular||
1010|102|P|block, sick sinus syndrome unless you have a pacemaker,||
1010|103|P|Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome),||
1010|104|P|heart failure, certain muscle/nerve disorders (muscular||
1010|105|P|dystrophy, myasthenia gravis), liver disease, kidney disease.||
1010|106|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1010|107|P|can make you more dizzy. Do not drive, use machinery, or do||
1010|108|P|anything that needs alertness until you can do it safely. Limit||
1010|109|P|alcoholic beverages. Talk to your doctor if you are using||
1010|110|P|marijuana (cannabis).||
1010|111|P|   Before having surgery, tell your doctor or dentist about all||
1010|112|P|the products you use (including prescription drugs,||
1010|113|P|nonprescription drugs, and herbal products).||
1010|114|P|   Older adults may be more sensitive to the side effects of this||
1010|115|P|drug, especially constipation, or swelling ankles/feet.||
1010|116|P|   During pregnancy, this medication should be used only when||
1010|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
1010|118|P|   This medication passes into breast milk, but is unlikely to||
1010|119|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1010|120|B|||
1010|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1010|122|I|medications work or increase your risk for serious side effects.||
1010|123|I|This document does not contain all possible drug interactions.||
1010|124|I|Keep a list of all the products you use (including||
1010|125|I|prescription/nonprescription drugs and herbal products) and share||
1010|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
1010|127|I|the dosage of any medicines without your doctor's approval.||
1010|128|I|   Some products that may interact with this drug include:||
1010|129|I|aliskiren, clonidine, disopyramide, dofetilide, fingolimod,||
1010|130|I|labetalol, lithium.||
1010|131|I|   Other medications can affect the removal of verapamil from||
1010|132|I|your body, which may affect how verapamil works. Examples include||
1010|133|I|erythromycin, rifamycins (such as rifampin), ritonavir, St.||
1010|134|I|John's wort, among others.||
1010|135|I|   Verapamil can slow down the removal of other medications from||
1010|136|I|your body, which may affect how they work. Examples of affected||
1010|137|I|drugs include colchicine, elacestrant, fezolinetant, flibanserin,||
1010|138|I|ivabradine, lomitapide, midazolam, rilzabrutinib, taletrectinib,||
1010|139|I|triazolam, among others.||
1010|140|I|   Some products have ingredients that could raise your heart||
1010|141|I|rate or blood pressure. Tell your pharmacist what products you||
1010|142|I|are using, and ask how to use them safely (especially||
1010|143|I|cough-and-cold products, diet aids, or NSAIDs such as||
1010|144|I|ibuprofen/naproxen).||
1010|145|B|||
1010|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1010|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1010|148|O|poison control center right away. US residents can call||
1010|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1010|150|O|Symptoms of overdose may include: very slow heartbeat, severe||
1010|151|O|dizziness, fainting.||
1010|152|B|||
1010|153|N|NOTES:  Do not share this medication with others.||
1010|154|N|   Lifestyle changes that may help this medication work better||
1010|155|N|include exercising, stopping smoking, and eating a||
1010|156|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1010|157|N|details.||
1010|158|N|   Lab and/or medical tests (such as liver function) should be||
1010|159|N|done while you are taking this medication. Keep all medical and||
1010|160|N|lab appointments. Consult your doctor for more details.||
1010|161|N|   Check your blood pressure and pulse (heart rate) regularly||
1010|162|N|while taking this medication. Learn how to check your own blood||
1010|163|N|pressure and pulse at home, and share the results with your||
1010|164|N|doctor.||
1010|165|N|   There are different brands and types of this medication||
1010|166|N|available. Some do not have the same effects. Do not change||
1010|167|N|brands or types without consulting your doctor or pharmacist.||
1010|168|B|||
1010|169|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1010|170|D|remember. If it is near the time of the next dose, skip the||
1010|171|D|missed dose. Take your next dose at the regular time. Do not||
1010|172|D|double the dose to catch up.||
1010|173|B|||
1010|174|R|STORAGE:  Store at room temperature away from light and moisture.||
1010|175|R|Do not store in the bathroom. Keep all medications away from||
1010|176|R|children and pets.||
1010|177|R|   Do not flush medications down the toilet or pour them into a||
1010|178|R|drain unless instructed to do so. Properly discard this product||
1010|179|R|when it is expired or no longer needed. Consult your pharmacist||
1010|180|R|or local waste disposal company.||
1010|181|B|||
1010|182|M|MEDICAL ALERT:  Your condition can cause complications in a||
1010|183|M|medical emergency. For information about enrolling in MedicAlert,||
1010|184|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1010|185|B|||
1010|186|A|Information last revised September 2025.||
1010|187|A|Copyright(c) 2025 First Databank, Inc.||
1010|188|B|||
1013|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1013|002|Z|does NOT have all possible information about this product. This||
1013|003|Z|information does not assure that this product is safe, effective,||
1013|004|Z|or appropriate for you. This information is not individual||
1013|005|Z|medical advice and does not substitute for the advice of your||
1013|006|Z|health care professional. Always ask your health care||
1013|007|Z|professional for complete information about this product and your||
1013|008|Z|specific health needs.||
1013|009|B|||
1013|010|T|TIMOLOL SOLUTION-GEL - OPHTHALMIC||
1013|011|F|(TIE-moh-lohl)||
1013|012|B|||
1013|013|C|COMMON BRAND NAME(S): Timoptic-XE||
1013|014|B|||
1013|015|U|USES:  This medication is used to treat high pressure inside the||
1013|016|U|eye due to glaucoma (open angle-type) or other eye diseases (such||
1013|017|U|as ocular hypertension). Lowering high pressure inside the eye||
1013|018|U|helps to prevent blindness. This medication works by decreasing||
1013|019|U|the amount of fluid within the eye. Timolol belongs to a class of||
1013|020|U|drugs known as beta-blockers.||
1013|021|B|||
1013|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1013|023|H|from your pharmacist before you start using timolol and each time||
1013|024|H|you get a refill. If you have any questions, ask your doctor or||
1013|025|H|pharmacist.||
1013|026|H|   Use this medication in the affected eye(s) as directed by your||
1013|027|H|doctor, usually once a day.||
1013|028|H|   Apply other eye medications at least 10 minutes before timolol||
1013|029|H|gel solution.||
1013|030|H|   To apply eye drops, wash your hands first. To avoid||
1013|031|H|contamination, do not touch the dropper tip or let it touch your||
1013|032|H|eye or any other surface.||
1013|033|H|   If you wear contact lenses, remove them before using the eye||
1013|034|H|drops. Ask your doctor how long you should wait after using this||
1013|035|H|medication before putting in your contact lenses.||
1013|036|H|   With the cap on tightly, turn the eye drop bottle upside down||
1013|037|H|and shake once before each use. You do not need to shake the||
1013|038|H|container more than once.||
1013|039|H|   Tilt your head back, look upward and pull down the lower||
1013|040|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1013|041|H|and place one drop in your eye. Look downward and gently close||
1013|042|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
1013|043|H|your eye (near the nose) and apply gentle pressure. Try not to||
1013|044|H|blink and do not rub your eye. This will prevent the medication||
1013|045|H|from draining out. Repeat these steps for your other eye if so||
1013|046|H|directed.||
1013|047|H|   Do not rinse the dropper. Replace the dropper cap after each||
1013|048|H|use.||
1013|049|H|   Wait several minutes for your vision to clear before driving||
1013|050|H|or operating machinery.||
1013|051|H|   Use this medication regularly in order to get the most benefit||
1013|052|H|from it. To help you remember, use it at the same time each day.||
1013|053|H|Keep using this medication even if you feel well. Most people||
1013|054|H|with glaucoma or high pressure in the eyes do not feel sick.||
1013|055|B|||
1013|056|S|SIDE EFFECTS:  Temporary blurred vision, temporary||
1013|057|S|burning/stinging/itching/redness of the eye, watery eyes, dry||
1013|058|S|eyes, feeling as if something is in the eye, or headache may||
1013|059|S|occur. If any of these effects last or get worse, notify your||
1013|060|S|doctor or pharmacist promptly.||
1013|061|S|   Remember that this medication has been prescribed because your||
1013|062|S|doctor has judged that the benefit to you is greater than the||
1013|063|S|risk of side effects. Many people using this medication do not||
1013|064|S|have serious side effects.||
1013|065|S|   Tell your doctor right away if you have any serious side||
1013|066|S|effects, including: dizziness, eye pain/swelling/discharge,||
1013|067|S|slow/irregular heartbeat, muscle weakness, mental/mood changes,||
1013|068|S|coldness/numbness/pain in the hands or feet, vision changes,||
1013|069|S|unusual tiredness/weakness.||
1013|070|S|   Get medical help right away if you have any very serious side||
1013|071|S|effects, including: dizziness that doesn't stop, trouble||
1013|072|S|breathing, sudden unexplained weight gain, chest pain, weakness||
1013|073|S|on one side of the body, trouble speaking, confusion, fainting.||
1013|074|S|   A very serious allergic reaction to this drug is rare.||
1013|075|S|However, get medical help right away if you notice any symptoms||
1013|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1013|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1013|078|S|breathing.||
1013|079|S|   This is not a complete list of possible side effects. If you||
1013|080|S|notice other effects not listed above, contact your doctor or||
1013|081|S|pharmacist.||
1013|082|S|   In the US -||
1013|083|S|   Call your doctor for medical advice about side effects. You||
1013|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1013|085|S|www.fda.gov/medwatch.||
1013|086|S|   In Canada - Call your doctor for medical advice about side||
1013|087|S|effects. You may report side effects to Health Canada at||
1013|088|S|1-866-234-2345.||
1013|089|B|||
1013|090|P|PRECAUTIONS:  Before using timolol, tell your doctor or||
1013|091|P|pharmacist if you are allergic to it; or if you have any other||
1013|092|P|allergies. This product may contain inactive ingredients, which||
1013|093|P|can cause allergic reactions or other problems. Talk to your||
1013|094|P|pharmacist for more details.||
1013|095|P|   Before using this medication, tell your doctor or pharmacist||
1013|096|P|your medical history, especially of: lung disease (such as||
1013|097|P|current or past history of asthma, severe chronic obstructive||
1013|098|P|pulmonary disease), certain types of irregular heartbeats (such||
1013|099|P|as sinus bradycardia, second or third degree AV block), certain||
1013|100|P|types of heart disease (such as severe heart failure), kidney||
1013|101|P|disease, liver disease, diabetes, low blood flow to the brain||
1013|102|P|(cerebrovascular insufficiency), overactive thyroid disease,||
1013|103|P|muscle weakness disorders, severe allergies.||
1013|104|P|   If you develop an eye infection or injury, or have eye||
1013|105|P|surgery, check with your doctor about whether you should continue||
1013|106|P|to use your current bottle of timolol. You may be advised to||
1013|107|P|start using a new bottle.||
1013|108|P|   Before having surgery, tell your doctor or dentist about all||
1013|109|P|the products you use (including prescription drugs,||
1013|110|P|nonprescription drugs, and herbal products).||
1013|111|P|   This product may prevent the fast/pounding heartbeat you would||
1013|112|P|usually feel when your blood sugar level falls too low||
1013|113|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
1013|114|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
1013|115|P|blood sugar level, such as dizziness and sweating, are not||
1013|116|P|affected by this drug.||
1013|117|P|   If you have diabetes, this product may make it harder to||
1013|118|P|control your blood sugar levels. Check your blood sugar levels||
1013|119|P|regularly as directed by your doctor. Tell your doctor right away||
1013|120|P|if you have symptoms of high blood sugar such as increased||
1013|121|P|thirst/urination. Your doctor may need to adjust your diabetes||
1013|122|P|medication, exercise program, or diet.||
1013|123|P|   After you apply this drug, your vision may become temporarily||
1013|124|P|blurred. Do not drive, use machinery, or do anything that needs||
1013|125|P|clear vision until you can do it safely.||
1013|126|P|   During pregnancy, this medication should be used only when||
1013|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
1013|128|P|   This drug passes into breast milk. Consult your doctor before||
1013|129|P|breastfeeding.||
1013|130|B|||
1013|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1013|132|I|medications work or increase your risk for serious side effects.||
1013|133|I|This document does not contain all possible drug interactions.||
1013|134|I|Keep a list of all the products you use (including||
1013|135|I|prescription/nonprescription drugs and herbal products) and share||
1013|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
1013|137|I|the dosage of any medicines without your doctor's approval.||
1013|138|I|   Some products that may interact with this drug include: oral||
1013|139|I|beta-blockers (such as propranolol), clonidine, certain||
1013|140|I|antidepressants (including SSRIs such as fluoxetine), digoxin,||
1013|141|I|epinephrine, methyldopa, quinidine.||
1013|142|B|||
1013|143|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1013|144|O|has overdosed and has serious symptoms such as passing out or||
1013|145|O|trouble breathing, call 911. Otherwise, call a poison control||
1013|146|O|center right away. US residents can call 1-800-222-1222. Canada||
1013|147|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1013|148|O|include: trouble breathing or slow/irregular heartbeat.||
1013|149|B|||
1013|150|N|NOTES:  Do not share this medication with others.||
1013|151|N|   Lab and/or medical tests (such as eye exams) should be done||
1013|152|N|while you are using this medication. Keep all medical and lab||
1013|153|N|appointments. Consult your doctor for more details.||
1013|154|B|||
1013|155|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1013|156|D|If it is near the time of the next dose, skip the missed dose.||
1013|157|D|Use your next dose at the regular time. Do not double the dose to||
1013|158|D|catch up.||
1013|159|B|||
1013|160|R|STORAGE:  Different brands of this medication have different||
1013|161|R|storage needs. Check the product package for instructions on how||
1013|162|R|to store your brand, or ask your pharmacist. Keep all medications||
1013|163|R|away from children and pets.||
1013|164|R|   This product is normally colorless. Discard the solution if it||
1013|165|R|changes color, becomes cloudy, or develops particles.||
1013|166|R|   Do not flush medications down the toilet or pour them into a||
1013|167|R|drain unless instructed to do so. Properly discard this product||
1013|168|R|when it is expired or no longer needed. Consult your pharmacist||
1013|169|R|or local waste disposal company.||
1013|170|B|||
1013|171|A|Information last revised November 2024.||
1013|172|A|Copyright(c) 2025 First Databank, Inc.||
1013|173|B|||
1014|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1014|002|Z|does NOT have all possible information about this product. This||
1014|003|Z|information does not assure that this product is safe, effective,||
1014|004|Z|or appropriate for you. This information is not individual||
1014|005|Z|medical advice and does not substitute for the advice of your||
1014|006|Z|health care professional. Always ask your health care||
1014|007|Z|professional for complete information about this product and your||
1014|008|Z|specific health needs.||
1014|009|B|||
1014|010|T|KETOCONAZOLE FOAM - TOPICAL||
1014|011|F|(kee-toe-CON-uh-zole)||
1014|012|B|||
1014|013|C|COMMON BRAND NAME(S): Extina||
1014|014|B|||
1014|015|U|USES:  This medication is used to treat a certain skin condition||
1014|016|U|(seborrheic dermatitis). In this condition, it is believed that a||
1014|017|U|fungus (Malassezia furfur) infects the skin, resulting in dry,||
1014|018|U|flaky skin (scaling) on the scalp, face, ears, chest, or upper||
1014|019|U|back. Ketoconazole is an azole antifungal drug that works by||
1014|020|U|stopping the growth of fungus.||
1014|021|B|||
1014|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1014|023|H|from your pharmacist before you start using ketoconazole and each||
1014|024|H|time you get a refill. If you have any questions, ask your doctor||
1014|025|H|or pharmacist.||
1014|026|H|   If the can is warm or the foam is runny, place the can under||
1014|027|H|cool running water for a few minutes before using.||
1014|028|H|   Use this medication on the skin only. Clean and thoroughly dry||
1014|029|H|the area to be treated. To keep the medication from melting on||
1014|030|H|your fingers, wash your hands with cold water and dry thoroughly||
1014|031|H|before applying. Hold the can upright. Do not spray the||
1014|032|H|medication directly on the affected area or on your hands.||
1014|033|H|Instead, spray the medication into the cap of the can or some||
1014|034|H|other cool, clean surface. Using your fingertips, pick up the||
1014|035|H|medication and gently and thoroughly rub into the affected areas||
1014|036|H|as directed by your doctor, usually 2 times daily for 4 weeks. If||
1014|037|H|treating the scalp, part your hair 1 section at a time, and apply||
1014|038|H|the medication directly to the affected scalp area, not the hair.||
1014|039|H|   Do not apply this medication in the eyes, nose, mouth, or||
1014|040|H|inside the vagina. If you do get the medication in those areas,||
1014|041|H|flush with plenty of water.||
1014|042|H|   Wash your hands after applying the medication.||
1014|043|H|   Use this medication regularly to get the most benefit from it.||
1014|044|H|To help you remember, use it at the same times each day.||
1014|045|H|   Tell your doctor if your condition gets worse or does not get||
1014|046|H|better after 4 weeks of treatment.||
1014|047|B|||
1014|048|S|SIDE EFFECTS:  Burning or irritation at the application site may||
1014|049|S|occur. If either of these effects last or get worse, tell your||
1014|050|S|doctor or pharmacist promptly.||
1014|051|S|   Remember that this medication has been prescribed because your||
1014|052|S|doctor has judged that the benefit to you is greater than the||
1014|053|S|risk of side effects. Many people using this medication do not||
1014|054|S|have serious side effects.||
1014|055|S|   A very serious allergic reaction to this drug is rare.||
1014|056|S|However, get medical help right away if you notice any symptoms||
1014|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1014|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1014|059|S|breathing.||
1014|060|S|   This is not a complete list of possible side effects. If you||
1014|061|S|notice other effects not listed above, contact your doctor or||
1014|062|S|pharmacist.||
1014|063|S|   In the US -||
1014|064|S|   Call your doctor for medical advice about side effects. You||
1014|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1014|066|S|www.fda.gov/medwatch.||
1014|067|S|   In Canada - Call your doctor for medical advice about side||
1014|068|S|effects. You may report side effects to Health Canada at||
1014|069|S|1-866-234-2345.||
1014|070|B|||
1014|071|P|PRECAUTIONS:  Before using ketoconazole, tell your doctor or||
1014|072|P|pharmacist if you are allergic to it; or to other azole||
1014|073|P|antifungals (such as clotrimazole, miconazole); or if you have||
1014|074|P|any other allergies. This product may contain inactive||
1014|075|P|ingredients, which can cause allergic reactions or other||
1014|076|P|problems. Talk to your pharmacist for more details.||
1014|077|P|   Before using this medication, tell your doctor or pharmacist||
1014|078|P|your medical history.||
1014|079|P|   This medication may make you more sensitive to the sun. Limit||
1014|080|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1014|081|P|sunscreen and wear protective clothing when outdoors. Tell your||
1014|082|P|doctor right away if you get sunburned or have skin||
1014|083|P|blisters/redness.||
1014|084|P|   During pregnancy, this medication should be used only when||
1014|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
1014|086|P|   It is unknown if this drug passes into breast milk when||
1014|087|P|applied to the skin. Consult your doctor before breastfeeding.||
1014|088|B|||
1014|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1014|090|I|medications work or increase your risk for serious side effects.||
1014|091|I|This document does not contain all possible drug interactions.||
1014|092|I|Keep a list of all the products you use (including||
1014|093|I|prescription/nonprescription drugs and herbal products) and share||
1014|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
1014|095|I|the dosage of any medicines without your doctor's approval.||
1014|096|B|||
1014|097|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1014|098|O|has overdosed and has serious symptoms such as passing out or||
1014|099|O|trouble breathing, call 911. Otherwise, call a poison control||
1014|100|O|center right away. US residents can call 1-800-222-1222. Canada||
1014|101|O|residents can call 1-844-764-7669.||
1014|102|B|||
1014|103|N|NOTES:  Do not share this medication with others.||
1014|104|N|   This medication has been prescribed for your current condition||
1014|105|N|only. Do not use it later for another skin condition unless told||
1014|106|N|to do so by your doctor. A different medication may be necessary||
1014|107|N|in that case.||
1014|108|B|||
1014|109|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1014|110|D|If it is near the time of the next dose, skip the missed dose.||
1014|111|D|Use your next dose at the regular time. Do not double the dose to||
1014|112|D|catch up.||
1014|113|B|||
1014|114|R|STORAGE:  Store at room temperature. Do not store in the||
1014|115|R|refrigerator or freezer. This product is flammable. Keep it away||
1014|116|R|from heat and open flame. Keep all medications away from children||
1014|117|R|and pets.||
1014|118|R|   Do not flush medications down the toilet or pour them into a||
1014|119|R|drain unless instructed to do so. Properly discard this product||
1014|120|R|when it is expired or no longer needed. Consult your pharmacist||
1014|121|R|or local waste disposal company.||
1014|122|B|||
1014|123|A|Information last revised July 2025.||
1014|124|A|Copyright(c) 2025 First Databank, Inc.||
1014|125|B|||
1016|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1016|002|Z|does NOT have all possible information about this product. This||
1016|003|Z|information does not assure that this product is safe, effective,||
1016|004|Z|or appropriate for you. This information is not individual||
1016|005|Z|medical advice and does not substitute for the advice of your||
1016|006|Z|health care professional. Always ask your health care||
1016|007|Z|professional for complete information about this product and your||
1016|008|Z|specific health needs.||
1016|009|B|||
1016|010|T|MICONAZOLE/ZINC OXIDE/PETROLATUM - TOPICAL||
1016|011|F|(mye-KON-a-zole/zink-OX-ide/peh-truh-LAY-tum)||
1016|012|B|||
1016|013|C|COMMON BRAND NAME(S): Vusion||
1016|014|B|||
1016|015|U|USES:  This product is used by children to treat diaper rash with||
1016|016|U|a yeast infection, along with proper cleaning of the diaper area||
1016|017|U|and frequent diaper changes. Miconazole is an azole antifungal||
1016|018|U|that works by preventing the growth of fungus. Zinc oxide and||
1016|019|U|petrolatum work by forming a barrier on the skin to protect it||
1016|020|U|from moisture and irritation.||
1016|021|U|   This product should not be used long-term or to prevent diaper||
1016|022|U|rash. Unnecessary use or misuse of this product can lead to its||
1016|023|U|decreased effectiveness.||
1016|024|B|||
1016|025|H|HOW TO USE:  Use this product on the skin only. Wash your hands||
1016|026|H|before and after applying this product. Gently clean the diaper||
1016|027|H|area with warm water and then pat dry. Gently apply a thin layer||
1016|028|H|of this medication to the affected area as directed by your||
1016|029|H|doctor, usually during each diaper change. Do not rub the||
1016|030|H|medication into the skin or it may cause more irritation. This||
1016|031|H|medication is usually used for 7 days.||
1016|032|H|   Do not apply the medication in the eyes, nose, mouth, or||
1016|033|H|inside the vagina. If you do get the medication in those areas,||
1016|034|H|flush with plenty of water.||
1016|035|H|   Use this medication regularly for the most benefit. Remember||
1016|036|H|to use it with every diaper change.||
1016|037|H|   Continue to use this product for the full length of treatment,||
1016|038|H|even if symptoms disappear after a few days. Stopping the||
1016|039|H|medication too early may result in a return of the infection.||
1016|040|H|   Do not use this product for longer than prescribed.||
1016|041|H|   Tell the doctor if your child's condition lasts after 7 days||
1016|042|H|of treatment or if it gets worse.||
1016|043|B|||
1016|044|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1016|045|S|because the doctor has judged that the benefit to your child is||
1016|046|S|greater than the risk of side effects. Many people using this||
1016|047|S|medication do not have serious side effects.||
1016|048|S|   Tell your doctor right away if you have any serious side||
1016|049|S|effects, including: increased irritation at the application site.||
1016|050|S|   A very serious allergic reaction to this drug is rare.||
1016|051|S|However, get medical help right away if you notice any symptoms||
1016|052|S|of a serious allergic reaction, including: rash, itching/swelling||
1016|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1016|054|S|breathing.||
1016|055|S|   This is not a complete list of possible side effects. If you||
1016|056|S|notice other effects not listed above, contact your doctor or||
1016|057|S|pharmacist.||
1016|058|S|   In the US -||
1016|059|S|   Call your doctor for medical advice about side effects. You||
1016|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1016|061|S|www.fda.gov/medwatch.||
1016|062|S|   In Canada - Call your doctor for medical advice about side||
1016|063|S|effects. You may report side effects to Health Canada at||
1016|064|S|1-866-234-2345.||
1016|065|B|||
1016|066|P|PRECAUTIONS:  Before using this product, tell the doctor or||
1016|067|P|pharmacist if your child is allergic to miconazole, zinc oxide,||
1016|068|P|or petrolatum; or to other azole antifungals (such as||
1016|069|P|clotrimazole, ketoconazole); or if your child has any other||
1016|070|P|allergies. This product may contain inactive ingredients, which||
1016|071|P|can cause allergic reactions or other problems. Talk to your||
1016|072|P|pharmacist for more details.||
1016|073|P|   Before using this medication, tell the doctor or pharmacist||
1016|074|P|your child's medical history.||
1016|075|P|   During pregnancy, this medication should be used only when||
1016|076|P|clearly needed. Pregnant women should use caution when applying||
1016|077|P|this medication on their children. Discuss the risks and benefits||
1016|078|P|with your doctor.||
1016|079|P|   It is unknown if this drug passes into breast milk.||
1016|080|P|Breastfeeding women should use caution when applying this||
1016|081|P|medication on their children. Consult your doctor before||
1016|082|P|breastfeeding.||
1016|083|B|||
1016|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1016|085|I|medications work or increase your risk for serious side effects.||
1016|086|I|This document does not contain all possible drug interactions.||
1016|087|I|Keep a list of all the products your child uses (including||
1016|088|I|prescription/nonprescription drugs and herbal products) and share||
1016|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
1016|090|I|the dosage of any medicines without your doctor's approval.||
1016|091|B|||
1016|092|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1016|093|O|has overdosed and has serious symptoms such as passing out or||
1016|094|O|trouble breathing, call 911. Otherwise, call a poison control||
1016|095|O|center right away. US residents can call 1-800-222-1222. Canada||
1016|096|O|residents can call 1-844-764-7669.||
1016|097|B|||
1016|098|N|NOTES:  Do not share this medication with others.||
1016|099|N|   This medication should be used for your baby's current||
1016|100|N|condition only. Do not use it later for another condition unless||
1016|101|N|told to do so by the doctor. A different medication may be||
1016|102|N|necessary in those cases.||
1016|103|N|   This product is not meant to replace frequent diaper changes.||
1016|104|N|To help the diaper rash heal and to prevent future diaper rashes,||
1016|105|N|check your baby's diaper often, and change the diaper whenever it||
1016|106|N|appears wet/dirty.||
1016|107|B|||
1016|108|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1016|109|D|If it is near the time of the next diaper change, skip the missed||
1016|110|D|dose. Use your next dose at the regular time. Do not double the||
1016|111|D|dose to catch up.||
1016|112|B|||
1016|113|R|STORAGE:  Store at room temperature. Keep all medications away||
1016|114|R|from children and pets.||
1016|115|R|   Do not flush medications down the toilet or pour them into a||
1016|116|R|drain unless instructed to do so. Properly discard this product||
1016|117|R|when it is expired or no longer needed. Consult your pharmacist||
1016|118|R|or local waste disposal company.||
1016|119|B|||
1016|120|A|Information last revised May 2024.||
1016|121|A|Copyright(c) 2025 First Databank, Inc.||
1016|122|B|||
1018|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1018|002|Z|does NOT have all possible information about this product. This||
1018|003|Z|information does not assure that this product is safe, effective,||
1018|004|Z|or appropriate for you. This information is not individual||
1018|005|Z|medical advice and does not substitute for the advice of your||
1018|006|Z|health care professional. Always ask your health care||
1018|007|Z|professional for complete information about this product and your||
1018|008|Z|specific health needs.||
1018|009|B|||
1018|010|T|BUTORPHANOL - NASAL||
1018|011|F|(bue-TOR-fa-nol TAR-trate)||
1018|012|B|||
1018|013|C|COMMON BRAND NAME(S): Stadol NS||
1018|014|B|||
1018|015|W|WARNING:  Butorphanol has a risk for abuse and addiction, which||
1018|016|W|can lead to overdose and death. Butorphanol may also cause||
1018|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
1018|018|W|your doctor should have you use the smallest dose of butorphanol||
1018|019|W|that works, and use it for the shortest possible time. See also||
1018|020|W|How to Use section for more information about addiction.||
1018|021|W|   Ask your doctor or pharmacist if you should have medication||
1018|022|W|available to treat opioid overdose (such as naloxone, nalmefene)||
1018|023|W|Teach your family or household members about the signs of an||
1018|024|W|opioid overdose and how to treat it.||
1018|025|W|   The risk for severe breathing problems is higher when you||
1018|026|W|start this medication and after a dose increase, or if you use||
1018|027|W|the wrong dose/strength. Using this medication with alcohol or||
1018|028|W|other drugs that can cause drowsiness or breathing problems may||
1018|029|W|cause very serious side effects, including death. Also, other||
1018|030|W|medications can affect the removal of butorphanol from your body,||
1018|031|W|which may affect how butorphanol works. Be sure you know how to||
1018|032|W|use butorphanol and what other drugs you should avoid taking with||
1018|033|W|it. See also Drug Interactions section. Get medical help right||
1018|034|W|away if any of these very serious side effects occur:||
1018|035|W|slow/shallow breathing, unusual lightheadedness, severe||
1018|036|W|drowsiness/dizziness, difficulty waking up.||
1018|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1018|038|W|or abuse. If someone accidentally swallows or uses this drug, get||
1018|039|W|medical help right away.||
1018|040|W|   Before using this medication, women of childbearing age should||
1018|041|W|talk with their doctor(s) about the risks and benefits. Tell your||
1018|042|W|doctor if you are pregnant or if you plan to become pregnant.||
1018|043|W|During pregnancy, this medication should be used only when||
1018|044|W|clearly needed. It may slightly increase the risk of birth||
1018|045|W|defects if used during the first two months of pregnancy. Also,||
1018|046|W|using it for a long time or in high doses near the expected||
1018|047|W|delivery date may harm the unborn baby. To lessen the risk, use||
1018|048|W|the smallest effective dose for the shortest possible time.||
1018|049|W|Babies born to mothers who use this drug for a long time may||
1018|050|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1018|051|W|doctor right away if you notice any symptoms in your newborn baby||
1018|052|W|such as crying that doesn't stop, slow/shallow breathing,||
1018|053|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1018|054|W|difficulty gaining weight.||
1018|055|B|||
1018|056|U|USES:  This medication is used to treat moderate to severe pain,||
1018|057|U|including pain from surgery, muscle pain, and migraine headaches.||
1018|058|U|Butorphanol is an opioid pain reliever similar to morphine. It||
1018|059|U|acts on certain centers in the brain to give you pain relief.||
1018|060|U|   Butorphanol can also block the effects of opioids and can||
1018|061|U|cause withdrawal symptoms in people dependent on opioids. If||
1018|062|U|possible, people who have recently used opioids in high doses or||
1018|063|U|for a long time should not use butorphanol. (See also Side||
1018|064|U|Effects section.)||
1018|065|B|||
1018|066|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1018|067|H|Patient Information Leaflet provided by your pharmacist before||
1018|068|H|you start using butorphanol and each time you get a refill. If||
1018|069|H|you have any questions, ask your doctor or pharmacist.||
1018|070|H|   This medication is a nasal spray. Have your doctor or||
1018|071|H|pharmacist show the proper way to use the nasal spray. For best||
1018|072|H|results, blow your nose gently before using. Follow the patient||
1018|073|H|instruction leaflet for priming the pump before first use. If the||
1018|074|H|spray has not been used in 48 hours, you may need to prime the||
1018|075|H|pump again before use.||
1018|076|H|   Use this product as directed by your doctor, usually every 3||
1018|077|H|to 4 hours as needed. This drug can cause a drop in blood||
1018|078|H|pressure, especially within the first hour after use. This can||
1018|079|H|cause dizziness, lightheadedness, and fainting. To lower this||
1018|080|H|risk, remain sitting or lying down after using this medication.||
1018|081|H|Follow your doctor's directions carefully.||
1018|082|H|   The dosage is based on your medical condition and response to||
1018|083|H|treatment. Do not increase the dose or use it more often than||
1018|084|H|directed by your doctor. Pain medications work best if they are||
1018|085|H|used as the first signs of pain occur. If you wait until the pain||
1018|086|H|has worsened, the medication may not work as well.||
1018|087|H|   If you use a nasal decongestant spray (such as oxymetazoline),||
1018|088|H|the decongestant may make this pain medication work more slowly.||
1018|089|H|Ask your doctor or pharmacist about using these 2 medications.||
1018|090|H|   If you have nausea, ask your doctor or pharmacist about ways||
1018|091|H|to decrease it (such as lying down for 1 to 2 hours with as||
1018|092|H|little head movement as possible).||
1018|093|H|   Suddenly stopping this medication may cause withdrawal,||
1018|094|H|especially if you have used it for a long time or in high doses.||
1018|095|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1018|096|H|Tell your doctor or pharmacist right away if you have any||
1018|097|H|withdrawal symptoms such as restlessness, mental/mood changes||
1018|098|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1018|099|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1018|100|H|aches, or sudden changes in behavior.||
1018|101|H|   Though it helps many people, this medication may sometimes||
1018|102|H|cause addiction. This risk may be higher if you have a||
1018|103|H|mental/mood disorder or a substance use disorder (such as overuse||
1018|104|H|of or addiction to drugs/alcohol). Use this medication exactly as||
1018|105|H|prescribed to lower the risk of addiction. Ask your doctor or||
1018|106|H|pharmacist for more details.||
1018|107|H|   When used for an extended period, this medication may not work||
1018|108|H|as well and may require different dosing. Talk with your doctor||
1018|109|H|if this medication stops working well.||
1018|110|H|   Tell your doctor if your pain does not get better or if it||
1018|111|H|gets worse, or if you have any new pain.||
1018|112|B|||
1018|113|S|SIDE EFFECTS:  See also Warning section.||
1018|114|S|   Drowsiness, dizziness, blurred vision, flushing, headache,||
1018|115|S|nausea, vomiting, constipation, nasal irritation/congestion,||
1018|116|S|trouble sleeping, dry mouth, and sweating may occur. If any of||
1018|117|S|these effects last or get worse, tell your doctor or pharmacist||
1018|118|S|promptly.||
1018|119|S|   To prevent constipation, eat dietary fiber, drink enough||
1018|120|S|water, and exercise. You may also need to take a laxative. Ask||
1018|121|S|your pharmacist which type of laxative is right for you.||
1018|122|S|   To reduce the risk of dizziness and lightheadedness, get up||
1018|123|S|slowly when rising from a sitting or lying position.||
1018|124|S|   Remember that this medication has been prescribed because your||
1018|125|S|doctor has judged that the benefit to you is greater than the||
1018|126|S|risk of side effects. Many people using this medication do not||
1018|127|S|have serious side effects.||
1018|128|S|   Tell your doctor right away if you have any serious side||
1018|129|S|effects, including: bleeding from the nose, interrupted breathing||
1018|130|S|during sleep (sleep apnea), mental/mood changes (such as anxiety,||
1018|131|S|confusion, hallucinations), fast/slow/irregular heartbeat, severe||
1018|132|S|stomach/abdominal pain, difficulty urinating, signs of your||
1018|133|S|adrenal glands not working well (such as loss of appetite,||
1018|134|S|unusual tiredness, weight loss), trouble swallowing.||
1018|135|S|   Get medical help right away if you have any very serious side||
1018|136|S|effects, including: difficult/slow/shallow breathing, severe||
1018|137|S|drowsiness/difficulty waking up, seizures.||
1018|138|S|   A very serious allergic reaction to this drug is rare.||
1018|139|S|However, get medical help right away if you notice any symptoms||
1018|140|S|of a serious allergic reaction, including: rash, itching/swelling||
1018|141|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1018|142|S|breathing.||
1018|143|S|   This is not a complete list of possible side effects. If you||
1018|144|S|notice other effects not listed above, contact your doctor or||
1018|145|S|pharmacist.||
1018|146|S|   In the US -||
1018|147|S|   Call your doctor for medical advice about side effects. You||
1018|148|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1018|149|S|www.fda.gov/medwatch.||
1018|150|S|   In Canada - Call your doctor for medical advice about side||
1018|151|S|effects. You may report side effects to Health Canada at||
1018|152|S|1-866-234-2345.||
1018|153|B|||
1018|154|P|PRECAUTIONS:  Before using butorphanol, tell your doctor or||
1018|155|P|pharmacist if you are allergic to it; or if you have any other||
1018|156|P|allergies. This product may contain inactive ingredients (such as||
1018|157|P|benzethonium chloride), which can cause allergic reactions or||
1018|158|P|other problems. Talk to your pharmacist for more details.||
1018|159|P|   Before using this medication, tell your doctor or pharmacist||
1018|160|P|your medical history, especially of: abdominal problems (such as||
1018|161|P|gallbladder disease, pancreatitis), adrenal gland problems (such||
1018|162|P|as Addison's disease), brain disorders (such as seizures, head||
1018|163|P|injury, tumor, increased intracranial pressure), heart problems||
1018|164|P|(such as irregular heartbeat, chest pain, recent heart attack),||
1018|165|P|high blood pressure, kidney disease, liver disease, breathing||
1018|166|P|problems (such as asthma, chronic obstructive pulmonary||
1018|167|P|disease-COPD, sleep apnea), mental/mood disorders (such as toxic||
1018|168|P|psychosis), a certain spinal problem (kyphoscoliosis),||
1018|169|P|stomach/intestinal problems (such as diarrhea due to infection,||
1018|170|P|paralytic ileus), personal or family history of a substance use||
1018|171|P|disorder (such as overuse of or addiction to drugs/alcohol),||
1018|172|P|difficulty urinating (such as due to enlarged prostate or||
1018|173|P|urethral stricture), underactive thyroid (hypothyroidism).||
1018|174|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1018|175|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1018|176|P|machinery, or do anything that needs alertness until you can do||
1018|177|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1018|178|P|are using marijuana (cannabis).||
1018|179|P|   Before having surgery, tell your doctor or dentist about all||
1018|180|P|the products you use (including prescription drugs,||
1018|181|P|nonprescription drugs, and herbal products).||
1018|182|P|   Older adults may be more sensitive to the side effects of this||
1018|183|P|drug, especially confusion, dizziness, drowsiness, and||
1018|184|P|slow/shallow breathing.||
1018|185|P|   During pregnancy, this medication should be used only when||
1018|186|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1018|187|P|benefits with your doctor. (See also Warning section.)||
1018|188|P|   This drug passes into breast milk. Consult your doctor before||
1018|189|P|breastfeeding.||
1018|190|B|||
1018|191|I|DRUG INTERACTIONS:  See also Warning section.||
1018|192|I|   Drug interactions may change how your medications work or||
1018|193|I|increase your risk for serious side effects. This document does||
1018|194|I|not contain all possible drug interactions. Keep a list of all||
1018|195|I|the products you use (including prescription/nonprescription||
1018|196|I|drugs and herbal products) and share it with your doctor and||
1018|197|I|pharmacist. Do not start, stop, or change the dosage of any||
1018|198|I|medicines without your doctor's approval.||
1018|199|I|   Some products that may interact with this drug include: MAO||
1018|200|I|inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue,||
1018|201|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1018|202|I|selegiline, tranylcypromine), naltrexone, nasal decongestants||
1018|203|I|(such as oxymetazoline), samidorphan.||
1018|204|I|   The risk of serious side effects (such as slow/shallow||
1018|205|I|breathing, severe drowsiness/dizziness) may be increased if this||
1018|206|I|medication is used with other products that may also cause||
1018|207|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1018|208|I|if you are taking other products such as other opioid pain or||
1018|209|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1018|210|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1018|211|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1018|212|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1018|213|I|cetirizine, diphenhydramine).||
1018|214|I|   Check the labels on all your medicines (such as allergy or||
1018|215|I|cough-and-cold products) because they may contain ingredients||
1018|216|I|that cause drowsiness. Ask your pharmacist about using those||
1018|217|I|products safely.||
1018|218|I|   Other medications can affect the removal of butorphanol from||
1018|219|I|your body, which may affect how butorphanol works. Examples||
1018|220|I|include azole antifungals (such as ketoconazole), macrolide||
1018|221|I|antibiotics (such as erythromycin), rifamycins (such as||
1018|222|I|rifabutin, rifampin), ritonavir, certain drugs used to treat||
1018|223|I|seizures (such as carbamazepine, phenytoin), among others.||
1018|224|I|   This medication may interfere with certain lab tests (such as||
1018|225|I|amylase/lipase levels), possibly causing false test results. Make||
1018|226|I|sure lab personnel and all your doctors know you use this drug.||
1018|227|B|||
1018|228|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1018|229|O|as passing out or trouble breathing, give them naloxone or||
1018|230|O|nalmefene if available, then call 911. If the person is awake and||
1018|231|O|has no symptoms, call a poison control center right away. US||
1018|232|O|residents can call 1-800-222-1222. Canada residents can call||
1018|233|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1018|234|O|breathing, coma.||
1018|235|B|||
1018|236|N|NOTES:  Do not share this medication with others. Sharing it is||
1018|237|N|against the law.||
1018|238|N|   This medication has been prescribed for your current condition||
1018|239|N|only. Do not use it later for another condition unless told to do||
1018|240|N|so by your doctor. A different medication may be necessary in||
1018|241|N|that case.||
1018|242|B|||
1018|243|D|MISSED DOSE:  Not applicable.||
1018|244|B|||
1018|245|R|STORAGE:  Store at room temperature. Keep all medications away||
1018|246|R|from children and pets.||
1018|247|R|   Do not flush medications down the toilet or pour them into a||
1018|248|R|drain unless instructed to do so. Properly discard this product||
1018|249|R|when it is expired or no longer needed. Consult your pharmacist||
1018|250|R|or local waste disposal company.||
1018|251|B|||
1018|252|A|Information last revised August 2025.||
1018|253|A|Copyright(c) 2025 First Databank, Inc.||
1018|254|B|||
1019|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1019|002|Z|does NOT have all possible information about this product. This||
1019|003|Z|information does not assure that this product is safe, effective,||
1019|004|Z|or appropriate for you. This information is not individual||
1019|005|Z|medical advice and does not substitute for the advice of your||
1019|006|Z|health care professional. Always ask your health care||
1019|007|Z|professional for complete information about this product and your||
1019|008|Z|specific health needs.||
1019|009|B|||
1019|010|T|DIVALPROEX SODIUM EXTENDED-RELEASE - ORAL||
1019|011|F|(dye-VAL-pro-ex SO-dee-um)||
1019|012|B|||
1019|013|C|COMMON BRAND NAME(S): Depakote ER||
1019|014|B|||
1019|015|W|WARNING:  Rarely, this medication has caused serious (sometimes||
1019|016|W|fatal) liver problems, usually within the first 6 months of||
1019|017|W|starting treatment. Lab tests should be performed before you||
1019|018|W|start treatment and periodically during treatment, especially||
1019|019|W|within the first 6 months, to monitor this side effect.||
1019|020|W|   The risk of serious liver problems is increased in children||
1019|021|W|younger than 2 years, especially if they have an inherited||
1019|022|W|metabolic disorder, severe seizure disorder with mental||
1019|023|W|retardation, organic brain disease, or if they take more than one||
1019|024|W|seizure medication. Talk with the doctor about the risks and||
1019|025|W|benefits of using this medication in children younger than 2||
1019|026|W|years.||
1019|027|W|   Due to an increased risk for liver problems, people with||
1019|028|W|certain inherited metabolic disorders (such as||
1019|029|W|Alpers-Huttenlocher syndrome) should not use this medication.||
1019|030|W|Children younger than 2 years who might have these disorders||
1019|031|W|should not use this medication. Children older than 2 years who||
1019|032|W|might have these disorders should be closely monitored during||
1019|033|W|treatment with divalproex sodium. Talk to your doctor for||
1019|034|W|details.||
1019|035|W|   This medication has rarely caused severe (sometimes fatal)||
1019|036|W|disease of the pancreas (pancreatitis). This may occur at any||
1019|037|W|time during treatment and can quickly worsen.||
1019|038|W|   Tell your doctor right away if you develop symptoms of liver||
1019|039|W|problems or pancreatitis such as nausea/vomiting that doesn't||
1019|040|W|stop, unusual tiredness, weakness, swelling of the face,||
1019|041|W|stomach/abdominal pain, loss of appetite, dark urine, or||
1019|042|W|yellowing eyes/skin.||
1019|043|W|   Taking this medication during pregnancy can cause birth||
1019|044|W|defects, may lower your child's IQ, and may increase the risk of||
1019|045|W|your child having certain brain/mental disorders (such as autism,||
1019|046|W|attention deficit/hyperactivity disorder). Men and women using||
1019|047|W|this medication should discuss the risks and benefits of this||
1019|048|W|medication, other treatment options, and use of reliable forms of||
1019|049|W|birth control with their doctor. If you are planning pregnancy,||
1019|050|W|or if you or your partner becomes pregnant or may be pregnant,||
1019|051|W|immediately talk to your doctor. If you are taking divalproex||
1019|052|W|sodium only to prevent migraine headaches, this medication must||
1019|053|W|not be used during pregnancy. If you are taking divalproex sodium||
1019|054|W|to treat seizures or mental/mood problems (such as bipolar||
1019|055|W|disorder), do not stop taking this medication unless directed by||
1019|056|W|your doctor. Untreated seizures and mental/mood problems (such as||
1019|057|W|bipolar disorder) are serious conditions that can harm both a||
1019|058|W|pregnant woman and her unborn baby.||
1019|059|B|||
1019|060|U|USES:  This medication is used to treat seizure disorders,||
1019|061|U|mental/mood conditions (such as manic phase of bipolar disorder),||
1019|062|U|and to prevent migraine headaches. It works by restoring the||
1019|063|U|balance of certain natural substances (neurotransmitters) in the||
1019|064|U|brain.||
1019|065|B|||
1019|066|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1019|067|H|Patient Information Leaflet provided by your pharmacist before||
1019|068|H|you start taking divalproex sodium and each time you get a||
1019|069|H|refill. If you have any questions, ask your doctor or pharmacist.||
1019|070|H|   Take this medication by mouth as directed by your doctor,||
1019|071|H|usually once daily. You may take it with food if stomach upset||
1019|072|H|occurs. Swallow the tablets whole. Do not crush or chew the||
1019|073|H|tablets. Doing so can release all of the drug at once, increasing||
1019|074|H|the risk of side effects.||
1019|075|H|   The dosage is based on your age, weight, medical condition,||
1019|076|H|response to treatment, and other medications you may be taking.||
1019|077|H|Be sure to tell your doctor and pharmacist about all the products||
1019|078|H|you use (including prescription drugs, nonprescription drugs, and||
1019|079|H|herbal products). Use this medication regularly in order to get||
1019|080|H|the most benefit from it. Remember to use it at the same time||
1019|081|H|each day to keep the amount of medication in your blood constant.||
1019|082|H|   If this medication is used for seizures, do not stop taking it||
1019|083|H|without consulting your doctor. Your condition may become worse||
1019|084|H|if the drug is suddenly stopped. Your dose may need to be||
1019|085|H|gradually decreased.||
1019|086|H|   Divalproex sodium does not relieve acute migraine headaches.||
1019|087|H|Take other medications as directed by your doctor for acute||
1019|088|H|attacks.||
1019|089|H|   Tell your doctor if your condition does not get better.||
1019|090|B|||
1019|091|S|SIDE EFFECTS:  See also Warning section.||
1019|092|S|   Diarrhea, dizziness, drowsiness, hair loss, blurred/double||
1019|093|S|vision, change in menstrual periods, ringing in the ears,||
1019|094|S|shakiness (tremor), unsteadiness, weight changes may occur. If||
1019|095|S|any of these effects last or get worse, tell your doctor or||
1019|096|S|pharmacist promptly.||
1019|097|S|   Remember that this medication has been prescribed because your||
1019|098|S|doctor has judged that the benefit to you is greater than the||
1019|099|S|risk of side effects. Many people using this medication do not||
1019|100|S|have serious side effects.||
1019|101|S|   A small number of people who take anticonvulsants for any||
1019|102|S|condition (such as seizure, bipolar disorder, pain) may||
1019|103|S|experience depression, suicidal thoughts/attempts, or other||
1019|104|S|mental/mood problems. Tell your doctor right away if you or your||
1019|105|S|family/caregiver notice any unusual/sudden changes in your mood,||
1019|106|S|thoughts, or behavior including signs of depression, suicidal||
1019|107|S|thoughts/attempts, thoughts about harming yourself.||
1019|108|S|   Severe (sometimes fatal) brain disorder (encephalopathy) has||
1019|109|S|rarely occurred, particularly in patients with certain metabolic||
1019|110|S|disorders (urea cycle disorders). Tell your doctor right away if||
1019|111|S|you develop unexplained weakness, vomiting, or sudden mental/mood||
1019|112|S|changes (such as confusion).||
1019|113|S|   Get medical help right away if you have any very serious side||
1019|114|S|effects, including: chest pain, easy bruising/unexplained||
1019|115|S|bleeding, fast/slow/irregular heartbeat, swelling of hands/feet,||
1019|116|S|uncontrolled eye movement (nystagmus), feeling cold/shivering,||
1019|117|S|rapid breathing, loss of consciousness.||
1019|118|S|   A very serious allergic reaction to this drug is rare.||
1019|119|S|However, get medical help right away if you notice any symptoms||
1019|120|S|of a serious allergic reaction, including: fever, swollen lymph||
1019|121|S|nodes, rash, itching/swelling (especially of the||
1019|122|S|face/tongue/throat), severe dizziness, trouble breathing.||
1019|123|S|   This is not a complete list of possible side effects. If you||
1019|124|S|notice other effects not listed above, contact your doctor or||
1019|125|S|pharmacist.||
1019|126|S|   In the US -||
1019|127|S|   Call your doctor for medical advice about side effects. You||
1019|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1019|129|S|www.fda.gov/medwatch.||
1019|130|S|   In Canada - Call your doctor for medical advice about side||
1019|131|S|effects. You may report side effects to Health Canada at||
1019|132|S|1-866-234-2345.||
1019|133|B|||
1019|134|P|PRECAUTIONS:  See also Warning section.||
1019|135|P|   Before taking divalproex sodium, tell your doctor or||
1019|136|P|pharmacist if you are allergic to it; or to valproic acid or||
1019|137|P|valproate sodium; or if you have any other allergies. This||
1019|138|P|product may contain inactive ingredients, which can cause||
1019|139|P|allergic reactions or other problems. Talk to your pharmacist for||
1019|140|P|more details.||
1019|141|P|   Before using this medication, tell your doctor or pharmacist||
1019|142|P|your medical history, especially of: liver disease, pancreatitis,||
1019|143|P|certain metabolic disorders (such as urea cycle disorders,||
1019|144|P|Alpers-Huttenlocher syndrome), alcohol abuse, bleeding problems,||
1019|145|P|brain disease (dementia), kidney disease, dehydration, poor||
1019|146|P|nutrition.||
1019|147|P|   To lower the chance of getting cut, bruised, or injured, use||
1019|148|P|caution with sharp objects like razors and nail cutters, and||
1019|149|P|avoid activities such as contact sports.||
1019|150|P|   Before having surgery, tell your doctor or dentist about all||
1019|151|P|the products you use (including prescription drugs,||
1019|152|P|nonprescription drugs, and herbal products).||
1019|153|P|   This drug may make you dizzy or drowsy or blur your vision.||
1019|154|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1019|155|P|drowsy. Do not drive, use machinery, or do anything that needs||
1019|156|P|alertness or clear vision until you can do it safely. Avoid||
1019|157|P|alcoholic beverages. Talk to your doctor if you are using||
1019|158|P|marijuana (cannabis).||
1019|159|P|   Children younger than 6 years may be at greater risk for liver||
1019|160|P|problems and pancreatitis.||
1019|161|P|   Older adults may be more sensitive to the side effects of this||
1019|162|P|drug, especially drowsiness, dizziness, unsteadiness, or tremor.||
1019|163|P|Drowsiness, dizziness, unsteadiness can increase the risk of||
1019|164|P|falling.||
1019|165|P|   Tell your doctor if you are pregnant or plan to become||
1019|166|P|pregnant. You should not become pregnant while using divalproex||
1019|167|P|sodium. Divalproex sodium may harm an unborn baby. If you become||
1019|168|P|pregnant, talk to your doctor right away about the risks and||
1019|169|P|benefits of this medication. See also Warning section.||
1019|170|P|   This medication passes into breast milk. Consult your doctor||
1019|171|P|before breastfeeding.||
1019|172|B|||
1019|173|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1019|174|I|medications work or increase your risk for serious side effects.||
1019|175|I|This document does not contain all possible drug interactions.||
1019|176|I|Keep a list of all the products you use (including||
1019|177|I|prescription/nonprescription drugs and herbal products) and share||
1019|178|I|it with your doctor and pharmacist. Do not start, stop, or change||
1019|179|I|the dosage of any medicines without your doctor's approval.||
1019|180|I|   Some products that may interact with this drug include:||
1019|181|I|certain antidepressants (such as amitriptyline, nortriptyline,||
1019|182|I|phenelzine), certain antibiotics (carbapenems such as imipenem),||
1019|183|I|mefloquine, orlistat, other medications for seizure (such as||
1019|184|I|ethosuximide, lamotrigine, rufinamide, topiramate), vorinostat,||
1019|185|I|warfarin, zidovudine.||
1019|186|I|   Tell your doctor or pharmacist if you are taking other||
1019|187|I|products that cause drowsiness including alcohol, marijuana||
1019|188|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1019|189|I|drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle||
1019|190|I|relaxants (such as carisoprodol, cyclobenzaprine), and opioid||
1019|191|I|pain relievers (such as codeine, hydrocodone).||
1019|192|I|   Check the labels on all your medicines (such as allergy or||
1019|193|I|cough-and-cold products) because they may contain ingredients||
1019|194|I|that cause drowsiness. Ask your pharmacist about using those||
1019|195|I|products safely.||
1019|196|I|   This drug may interfere with certain lab tests (such as urine||
1019|197|I|ketones). Make sure lab personnel and your doctors know you use||
1019|198|I|this medication.||
1019|199|B|||
1019|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1019|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1019|202|O|poison control center right away. US residents can call||
1019|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1019|204|O|Symptoms of overdose may include: excessive drowsiness, coma,||
1019|205|O|irregular/slow heartbeat.||
1019|206|B|||
1019|207|N|NOTES:  Do not share this medication with others.||
1019|208|N|   Lab and/or medical tests (such as drug levels, liver function,||
1019|209|N|complete blood counts, clotting tests) should be done before you||
1019|210|N|start taking this medication and while you are taking it. Keep||
1019|211|N|all medical and lab appointments. Consult your doctor for more||
1019|212|N|details.||
1019|213|B|||
1019|214|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1019|215|D|remember. If it is near the time of the next dose, skip the||
1019|216|D|missed dose. Take your next dose at the regular time. Do not||
1019|217|D|double the dose to catch up.||
1019|218|B|||
1019|219|R|STORAGE:  Store at room temperature away from light and moisture.||
1019|220|R|Do not store in the bathroom. Keep all medications away from||
1019|221|R|children and pets.||
1019|222|R|   Do not flush medications down the toilet or pour them into a||
1019|223|R|drain unless instructed to do so. Properly discard this product||
1019|224|R|when it is expired or no longer needed. Consult your pharmacist||
1019|225|R|or local waste disposal company.||
1019|226|B|||
1019|227|M|MEDICAL ALERT:  Your condition can cause complications in a||
1019|228|M|medical emergency. For information about enrolling in MedicAlert,||
1019|229|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1019|230|B|||
1019|231|A|Information last revised January 2025.||
1019|232|A|Copyright(c) 2025 First Databank, Inc.||
1019|233|B|||
1020|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1020|002|Z|does NOT have all possible information about this product. This||
1020|003|Z|information does not assure that this product is safe, effective,||
1020|004|Z|or appropriate for you. This information is not individual||
1020|005|Z|medical advice and does not substitute for the advice of your||
1020|006|Z|health care professional. Always ask your health care||
1020|007|Z|professional for complete information about this product and your||
1020|008|Z|specific health needs.||
1020|009|B|||
1020|010|T|MESALAMINE (5-AMINOSALICYLIC ACID) DELAYED-RELEASE - ORAL||
1020|011|F|(me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id)||
1020|012|B|||
1020|013|C|COMMON BRAND NAME(S): Asacol, Delzicol||
1020|014|B|||
1020|015|U|USES:  This medication is used to treat a certain bowel disease||
1020|016|U|(ulcerative colitis). It helps to reduce symptoms of ulcerative||
1020|017|U|colitis such as diarrhea, rectal bleeding, and stomach pain.||
1020|018|U|Mesalamine belongs to a class of drugs known as aminosalicylates.||
1020|019|U|It works by decreasing swelling in the colon.||
1020|020|B|||
1020|021|V|OTHER USES:  This section contains uses of this drug that are not||
1020|022|V|listed in the approved professional labeling for the drug but||
1020|023|V|that may be prescribed by your health care professional. Use this||
1020|024|V|drug for a condition that is listed in this section only if it||
1020|025|V|has been so prescribed by your health care professional.||
1020|026|V|   This drug may also be used for Crohn's disease.||
1020|027|B|||
1020|028|H|HOW TO USE:  Take this medication by mouth with or without food||
1020|029|H|as directed by your doctor, usually 3 times daily. Some brands||
1020|030|H|should be taken on an empty stomach at least 1 hour before or 2||
1020|031|H|hours after a meal. Consult your doctor or pharmacist for details||
1020|032|H|for your particular brand.||
1020|033|H|   Swallow this medication whole. Do not crush, chew, or break.||
1020|034|H|Doing so can keep the drug from being released properly into the||
1020|035|H|colon.||
1020|036|H|   Drink plenty of fluids during treatment with this medication||
1020|037|H|unless otherwise directed by your doctor. This will help prevent||
1020|038|H|kidney stones.||
1020|039|H|   The dosage is based on your medical condition and response to||
1020|040|H|treatment. Children's dosage is also based on weight. Different||
1020|041|H|brands of this medication deliver different amounts of||
1020|042|H|medication. Do not switch brands without your doctor's permission||
1020|043|H|and directions.||
1020|044|H|   Use this medication regularly to get the most benefit from it.||
1020|045|H|To help you remember, take it at the same times each day.||
1020|046|H|   Tell your doctor if your condition does not get better or if||
1020|047|H|it gets worse.||
1020|048|B|||
1020|049|S|SIDE EFFECTS:  Stomach upset, nausea/vomiting, constipation,||
1020|050|S|headache, or joint/muscle pain may occur. If any of these effects||
1020|051|S|last or get worse, tell your doctor or pharmacist promptly.||
1020|052|S|   You may sometimes see whole or partial tablets/capsules in||
1020|053|S|your stool. If this occurs often, tell your doctor. You may not||
1020|054|S|be absorbing enough of the medication.||
1020|055|S|   Remember that this medication has been prescribed because your||
1020|056|S|doctor has judged that the benefit to you is greater than the||
1020|057|S|risk of side effects. Many people using this medication do not||
1020|058|S|have serious side effects.||
1020|059|S|   Rarely, mesalamine can worsen ulcerative colitis. Tell your||
1020|060|S|doctor right away if your symptoms worsen after starting this||
1020|061|S|medication (such as increased abdominal pain/cramping, bloody||
1020|062|S|diarrhea).||
1020|063|S|   Tell your doctor right away if you have any serious side||
1020|064|S|effects, including: nausea/vomiting that doesn't stop, signs of||
1020|065|S|kidney problems (such as change in the amount of urine, blood in||
1020|066|S|the urine), dark urine, severe stomach/abdominal pain, yellowing||
1020|067|S|eyes/skin, chest pain, shortness of breath.||
1020|068|S|   A very serious allergic reaction to this drug is rare.||
1020|069|S|However, get medical help right away if you notice any symptoms||
1020|070|S|of a serious allergic reaction, including: fever, swollen lymph||
1020|071|S|nodes, rash, itching/swelling (especially of the||
1020|072|S|face/tongue/throat), severe dizziness, trouble breathing.||
1020|073|S|   This is not a complete list of possible side effects. If you||
1020|074|S|notice other effects not listed above, contact your doctor or||
1020|075|S|pharmacist.||
1020|076|S|   In the US -||
1020|077|S|   Call your doctor for medical advice about side effects. You||
1020|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1020|079|S|www.fda.gov/medwatch.||
1020|080|S|   In Canada - Call your doctor for medical advice about side||
1020|081|S|effects. You may report side effects to Health Canada at||
1020|082|S|1-866-234-2345.||
1020|083|B|||
1020|084|P|PRECAUTIONS:  Before taking mesalamine, tell your doctor or||
1020|085|P|pharmacist if you are allergic to it; or to other||
1020|086|P|aminosalicylates (such as balsalazide, olsalazine); or to||
1020|087|P|salicylates (such as aspirin, salsalate); or to sulfasalazine; or||
1020|088|P|if you have any other allergies. This product may contain||
1020|089|P|inactive ingredients, which can cause allergic reactions or other||
1020|090|P|problems. Talk to your pharmacist for more details.||
1020|091|P|   Before using this medication, tell your doctor or pharmacist||
1020|092|P|your medical history, especially of: kidney disease, liver||
1020|093|P|disease, stomach blockage (such as pyloric stenosis).||
1020|094|P|   This medication may make you more sensitive to the sun,||
1020|095|P|especially if you have skin problems (such as atopic dermatitis,||
1020|096|P|eczema). Limit your time in the sun. Avoid tanning booths and||
1020|097|P|sunlamps. Use sunscreen and wear protective clothing when||
1020|098|P|outdoors. Tell your doctor right away if you get sunburned or||
1020|099|P|have skin blisters/redness.||
1020|100|P|   Before having surgery, tell your doctor or dentist about all||
1020|101|P|the products you use (including prescription drugs,||
1020|102|P|nonprescription drugs, and herbal products).||
1020|103|P|   This medication is similar to aspirin. Children and teenagers||
1020|104|P|younger than 18 years should not take aspirin or aspirin-related||
1020|105|P|medications (such as salicylates) if they have chickenpox, flu,||
1020|106|P|or any undiagnosed illness, or if they have recently received a||
1020|107|P|vaccine. In these cases, taking aspirin increases the risk of||
1020|108|P|Reye's syndrome, a rare but serious illness.||
1020|109|P|   During pregnancy, this medication should be used only when||
1020|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
1020|111|P|   This medication passes into breast milk and may have||
1020|112|P|undesirable effects on a nursing infant. Consult your doctor||
1020|113|P|before breastfeeding.||
1020|114|B|||
1020|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1020|116|I|medications work or increase your risk for serious side effects.||
1020|117|I|This document does not contain all possible drug interactions.||
1020|118|I|Keep a list of all the products you use (including||
1020|119|I|prescription/nonprescription drugs and herbal products) and share||
1020|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1020|121|I|the dosage of any medicines without your doctor's approval.||
1020|122|I|   Mesalamine is very similar to balsalazide, olsalazine, and||
1020|123|I|sulfasalazine. Do not use medications containing balsalazide,||
1020|124|I|olsalazine, or sulfasalazine while using mesalamine.||
1020|125|I|   This medication may interfere with certain lab tests (such as||
1020|126|I|urine normetanephrine levels), possibly causing false test||
1020|127|I|results. Make sure lab personnel and all your doctors know you||
1020|128|I|use this drug.||
1020|129|B|||
1020|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1020|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1020|132|O|poison control center right away. US residents can call||
1020|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1020|134|O|Symptoms of overdose may include: ringing in the ears, confusion,||
1020|135|O|rapid breathing, seizures.||
1020|136|B|||
1020|137|N|NOTES:  Do not share this medication with others.||
1020|138|N|   Lab and/or medical tests (such as liver/kidney function) may||
1020|139|N|be done before you start taking this medication and while you are||
1020|140|N|taking it. Keep all medical and lab appointments. Consult your||
1020|141|N|doctor for more details.||
1020|142|B|||
1020|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1020|144|D|remember. If it is near the time of the next dose, skip the||
1020|145|D|missed dose. Take your next dose at the regular time. Do not||
1020|146|D|double the dose to catch up.||
1020|147|B|||
1020|148|R|STORAGE:  Store at room temperature away from light and moisture.||
1020|149|R|Do not store in the bathroom. If your medication bottle comes||
1020|150|R|with a desiccant, keep the desiccant in the bottle. Tightly close||
1020|151|R|the bottle when not in use. Keep all medications away from||
1020|152|R|children and pets.||
1020|153|R|   Do not flush medications down the toilet or pour them into a||
1020|154|R|drain unless instructed to do so. Properly discard this product||
1020|155|R|when it is expired or no longer needed. Consult your pharmacist||
1020|156|R|or local waste disposal company.||
1020|157|B|||
1020|158|A|Information last revised October 2024.||
1020|159|A|Copyright(c) 2025 First Databank, Inc.||
1020|160|B|||
1021|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1021|002|Z|does NOT have all possible information about this product. This||
1021|003|Z|information does not assure that this product is safe, effective,||
1021|004|Z|or appropriate for you. This information is not individual||
1021|005|Z|medical advice and does not substitute for the advice of your||
1021|006|Z|health care professional. Always ask your health care||
1021|007|Z|professional for complete information about this product and your||
1021|008|Z|specific health needs.||
1021|009|B|||
1021|010|T|TRIAMCINOLONE - DENTAL||
1021|011|F|(tri-am-SIN-oh-lone)||
1021|012|B|||
1021|013|C|COMMON BRAND NAME(S): Kenalog in Orabase, Oralone||
1021|014|B|||
1021|015|U|USES:  This medication is used for the temporary relief of||
1021|016|U|symptoms from mouth sores due to injury. This drug comes in a||
1021|017|U|dental paste that allows it to stick to the inside of the||
1021|018|U|mouth/cheeks/gums. It works by reducing the swelling, itching,||
1021|019|U|and pain that can occur with mouth sores. This medication is||
1021|020|U|known as a medium-strength corticosteroid.||
1021|021|B|||
1021|022|H|HOW TO USE:  Do not apply this medication in the eyes or on the||
1021|023|H|skin. It is to be used only inside the mouth.||
1021|024|H|   Dab or press (do not rub) a small amount of paste onto the||
1021|025|H|area to be treated until the paste sticks and a smooth, slippery||
1021|026|H|film develops. A cotton swab may be used to apply the paste. Do||
1021|027|H|not attempt to spread or rub the paste in. This will only cause||
1021|028|H|it to become crumbly, grainy, or gritty.||
1021|029|H|   Apply to the affected area as directed by your doctor or||
1021|030|H|dentist, usually 2 to 3 times daily after meals or at bedtime.||
1021|031|H|   The treated area should not be bandaged or otherwise covered||
1021|032|H|or wrapped unless your doctor or dentist directs you to do so.||
1021|033|H|   Mouth infections may worsen while you are using this||
1021|034|H|medication. Tell your doctor or dentist if your condition lasts||
1021|035|H|or gets worse after 7 to 14 days of treatment.||
1021|036|B|||
1021|037|S|SIDE EFFECTS:  Burning, itching, irritation, dryness, or redness||
1021|038|S|of the treated area may occur. If any of these effects last or||
1021|039|S|get worse, notify your doctor, dentist, or pharmacist promptly.||
1021|040|S|   Remember that this medication has been prescribed because your||
1021|041|S|doctor or dentist has judged that the benefit to you is greater||
1021|042|S|than the risk of side effects. Many people using this medication||
1021|043|S|do not have serious side effects.||
1021|044|S|   Tell your doctor right away if you have any serious side||
1021|045|S|effects, including: blistering, peeling.||
1021|046|S|   Rarely, it is possible this medication will be absorbed from||
1021|047|S|the mouth into the bloodstream. This can lead to side effects of||
1021|048|S|too much corticosteroid. These side effects are more likely in||
1021|049|S|children, and in people who use this medication for a long time.||
1021|050|S|Tell your doctor right away if any of the following side effects||
1021|051|S|occur: unusual/extreme tiredness, weight loss, headache, swelling||
1021|052|S|ankles/feet, increased thirst/urination, vision problems.||
1021|053|S|   A very serious allergic reaction to this drug is rare.||
1021|054|S|However, get medical help right away if you notice any symptoms||
1021|055|S|of a serious allergic reaction, including: rash, itching/swelling||
1021|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1021|057|S|breathing.||
1021|058|S|   This is not a complete list of possible side effects. If you||
1021|059|S|notice other effects not listed above, contact your doctor or||
1021|060|S|pharmacist.||
1021|061|S|   In the US -||
1021|062|S|   Call your doctor for medical advice about side effects. You||
1021|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1021|064|S|www.fda.gov/medwatch.||
1021|065|S|   In Canada - Call your doctor for medical advice about side||
1021|066|S|effects. You may report side effects to Health Canada at||
1021|067|S|1-866-234-2345.||
1021|068|B|||
1021|069|P|PRECAUTIONS:  Before using triamcinolone, tell your doctor or||
1021|070|P|pharmacist if you are allergic to it; or to other steroids (such||
1021|071|P|as hydrocortisone); or if you have any other allergies. This||
1021|072|P|product may contain inactive ingredients, which can cause||
1021|073|P|allergic reactions or other problems. Talk to your pharmacist for||
1021|074|P|more details.||
1021|075|P|   Before using this medication, tell your doctor, dentist, or||
1021|076|P|pharmacist your medical history, especially of: herpes-type||
1021|077|P|infection, other infections/sores of the mouth or throat.||
1021|078|P|   Rarely, using corticosteroid medications for a long time can||
1021|079|P|make it more difficult for your body to respond to physical||
1021|080|P|stress. Before having surgery or emergency treatment, or if you||
1021|081|P|get a serious illness/injury, tell your doctor or dentist that||
1021|082|P|you are using this medication or have used this medication within||
1021|083|P|the past few months.||
1021|084|P|   Though it is unlikely, this medication may temporarily slow||
1021|085|P|down a child's growth if used for a long time. See the doctor||
1021|086|P|regularly so your child's height can be checked.||
1021|087|P|   During pregnancy, this medication should be used only when||
1021|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
1021|089|P|   It is unknown if this form of triamcinolone passes into breast||
1021|090|P|milk. Consult your doctor before breastfeeding.||
1021|091|B|||
1021|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1021|093|I|medications work or increase your risk for serious side effects.||
1021|094|I|This document does not contain all possible drug interactions.||
1021|095|I|Keep a list of all the products you use (including||
1021|096|I|prescription/nonprescription drugs and herbal products) and share||
1021|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
1021|098|I|the dosage of any medicines without your doctor's approval.||
1021|099|B|||
1021|100|O|OVERDOSE:  Overdose with this medication is unlikely even if||
1021|101|O|swallowed. However, if someone has overdosed and has serious||
1021|102|O|symptoms such as passing out or trouble breathing, call 911.||
1021|103|O|Otherwise, call a poison control center right away. US residents||
1021|104|O|can call 1-800-222-1222. Canada residents can call||
1021|105|O|1-844-764-7669.||
1021|106|B|||
1021|107|N|NOTES:  Do not share this medication with others.||
1021|108|N|   This medication has been prescribed for your current condition||
1021|109|N|only. Do not use it later for another occurrence. A different||
1021|110|N|medication may be necessary in those cases.||
1021|111|N|   If you are directed to use this medication for a long time,||
1021|112|N|lab and/or medical tests (such as adrenal gland function, morning||
1021|113|N|cortisol blood test) may be done while you are using this||
1021|114|N|medication. Keep all medical and lab appointments. Consult your||
1021|115|N|doctor for more details.||
1021|116|B|||
1021|117|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1021|118|D|If it is near the time of the next dose, skip the missed dose.||
1021|119|D|Use your next dose at the regular time. Do not double the dose to||
1021|120|D|catch up.||
1021|121|B|||
1021|122|R|STORAGE:  Store at room temperature. Keep all medications away||
1021|123|R|from children and pets.||
1021|124|R|   Do not flush medications down the toilet or pour them into a||
1021|125|R|drain unless instructed to do so. Properly discard this product||
1021|126|R|when it is expired or no longer needed. Consult your pharmacist||
1021|127|R|or local waste disposal company.||
1021|128|B|||
1021|129|A|Information last revised January 2025.||
1021|130|A|Copyright(c) 2025 First Databank, Inc.||
1021|131|B|||
1023|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1023|002|Z|does NOT have all possible information about this product. This||
1023|003|Z|information does not assure that this product is safe, effective,||
1023|004|Z|or appropriate for you. This information is not individual||
1023|005|Z|medical advice and does not substitute for the advice of your||
1023|006|Z|health care professional. Always ask your health care||
1023|007|Z|professional for complete information about this product and your||
1023|008|Z|specific health needs.||
1023|009|B|||
1023|010|T|MESALAMINE (5-AMINOSALICYLIC ACID) DELAYED-RELEASE 1.2 GM - ORAL||
1023|011|F|(me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id)||
1023|012|B|||
1023|013|C|COMMON BRAND NAME(S): Lialda||
1023|014|B|||
1023|015|U|USES:  This medication is used to treat a certain bowel disease||
1023|016|U|(ulcerative colitis). It helps to reduce symptoms of ulcerative||
1023|017|U|colitis such as diarrhea, rectal bleeding, and stomach pain.||
1023|018|U|Mesalamine belongs to a class of drugs known as aminosalicylates.||
1023|019|U|It works by decreasing swelling in the colon.||
1023|020|B|||
1023|021|V|OTHER USES:  This section contains uses of this drug that are not||
1023|022|V|listed in the approved professional labeling for the drug but||
1023|023|V|that may be prescribed by your health care professional. Use this||
1023|024|V|drug for a condition that is listed in this section only if it||
1023|025|V|has been so prescribed by your health care professional.||
1023|026|V|   This drug may also be used for Crohn's disease.||
1023|027|B|||
1023|028|H|HOW TO USE:  Take this medication by mouth with a meal as||
1023|029|H|directed by your doctor, usually once daily.||
1023|030|H|   Swallow this medication whole. Do not crush, chew, or break||
1023|031|H|the tablets. Doing so can keep the drug from being released||
1023|032|H|properly into the colon.||
1023|033|H|   Drink plenty of fluids during treatment with this medication||
1023|034|H|unless otherwise directed by your doctor. This will help prevent||
1023|035|H|kidney stones.||
1023|036|H|   The dosage is based on your medical condition and response to||
1023|037|H|treatment. Children's dosage is also based on weight.||
1023|038|H|   Use this medication regularly to get the most benefit from it.||
1023|039|H|To help you remember, take it at the same time each day.||
1023|040|H|   Tell your doctor if your condition does not get better or if||
1023|041|H|it gets worse.||
1023|042|B|||
1023|043|S|SIDE EFFECTS:  Headache or abdominal pain may occur. If either of||
1023|044|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1023|045|S|promptly.||
1023|046|S|   Remember that this medication has been prescribed because your||
1023|047|S|doctor has judged that the benefit to you is greater than the||
1023|048|S|risk of side effects. Many people using this medication do not||
1023|049|S|have serious side effects.||
1023|050|S|   Rarely, mesalamine can worsen ulcerative colitis. Tell your||
1023|051|S|doctor right away if your symptoms worsen after starting this||
1023|052|S|medication (such as increased abdominal pain/cramping, bloody||
1023|053|S|diarrhea).||
1023|054|S|   Tell your doctor right away if you have any serious side||
1023|055|S|effects, including: nausea/vomiting that doesn't stop, signs of||
1023|056|S|kidney problems (such as change in the amount of urine, blood in||
1023|057|S|the urine), dark urine, severe stomach/abdominal pain, yellowing||
1023|058|S|eyes/skin, chest pain, shortness of breath.||
1023|059|S|   A very serious allergic reaction to this drug is rare.||
1023|060|S|However, get medical help right away if you notice any symptoms||
1023|061|S|of a serious allergic reaction, including: fever, swollen lymph||
1023|062|S|nodes, rash, itching/swelling (especially of the||
1023|063|S|face/tongue/throat), severe dizziness, trouble breathing.||
1023|064|S|   This is not a complete list of possible side effects. If you||
1023|065|S|notice other effects not listed above, contact your doctor or||
1023|066|S|pharmacist.||
1023|067|S|   In the US -||
1023|068|S|   Call your doctor for medical advice about side effects. You||
1023|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1023|070|S|www.fda.gov/medwatch.||
1023|071|S|   In Canada - Call your doctor for medical advice about side||
1023|072|S|effects. You may report side effects to Health Canada at||
1023|073|S|1-866-234-2345.||
1023|074|B|||
1023|075|P|PRECAUTIONS:  Before taking mesalamine, tell your doctor or||
1023|076|P|pharmacist if you are allergic to it; or to other||
1023|077|P|aminosalicylates (such as balsalazide, olsalazine); or to||
1023|078|P|salicylates (such as aspirin, salsalate); or to sulfasalazine; or||
1023|079|P|if you have any other allergies. This product may contain||
1023|080|P|inactive ingredients, which can cause allergic reactions or other||
1023|081|P|problems. Talk to your pharmacist for more details.||
1023|082|P|   Before using this medication, tell your doctor or pharmacist||
1023|083|P|your medical history, especially of: kidney disease, liver||
1023|084|P|disease, stomach blockage (such as pyloric stenosis).||
1023|085|P|   This medication may make you more sensitive to the sun,||
1023|086|P|especially if you have skin problems (such as atopic dermatitis,||
1023|087|P|eczema). Limit your time in the sun. Avoid tanning booths and||
1023|088|P|sunlamps. Use sunscreen and wear protective clothing when||
1023|089|P|outdoors. Tell your doctor right away if you get sunburned or||
1023|090|P|have skin blisters/redness.||
1023|091|P|   Before having surgery, tell your doctor or dentist about all||
1023|092|P|the products you use (including prescription drugs,||
1023|093|P|nonprescription drugs, and herbal products).||
1023|094|P|   This medication is similar to aspirin. Children and teenagers||
1023|095|P|younger than 18 years should not take aspirin or aspirin-related||
1023|096|P|medications (such as salicylates) if they have chickenpox, flu,||
1023|097|P|or any undiagnosed illness, or if they have recently received a||
1023|098|P|vaccine. In these cases, taking aspirin increases the risk of||
1023|099|P|Reye's syndrome, a rare but serious illness.||
1023|100|P|   During pregnancy, this medication should be used only when||
1023|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
1023|102|P|   This medication passes into breast milk and may have||
1023|103|P|undesirable effects on a nursing infant. Consult your doctor||
1023|104|P|before breastfeeding.||
1023|105|B|||
1023|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1023|107|I|medications work or increase your risk for serious side effects.||
1023|108|I|This document does not contain all possible drug interactions.||
1023|109|I|Keep a list of all the products you use (including||
1023|110|I|prescription/nonprescription drugs and herbal products) and share||
1023|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
1023|112|I|the dosage of any medicines without your doctor's approval.||
1023|113|I|   Mesalamine is very similar to balsalazide, olsalazine, and||
1023|114|I|sulfasalazine. Do not use medications containing balsalazide,||
1023|115|I|olsalazine, or sulfasalazine while using mesalamine.||
1023|116|I|   This medication may interfere with certain lab tests (such as||
1023|117|I|urine normetanephrine levels), possibly causing false test||
1023|118|I|results. Make sure lab personnel and all your doctors know you||
1023|119|I|use this drug.||
1023|120|B|||
1023|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1023|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1023|123|O|poison control center right away. US residents can call||
1023|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1023|125|O|Symptoms of overdose may include: ringing in the ears, confusion,||
1023|126|O|rapid breathing, seizures.||
1023|127|B|||
1023|128|N|NOTES:  Do not share this medication with others.||
1023|129|N|   Lab and/or medical tests (such as liver/kidney function) may||
1023|130|N|be done before you start taking this medication and while you are||
1023|131|N|taking it. Keep all medical and lab appointments. Consult your||
1023|132|N|doctor for more details.||
1023|133|B|||
1023|134|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1023|135|D|remember. If it is near the time of the next dose, skip the||
1023|136|D|missed dose. Take your next dose at the regular time. Do not||
1023|137|D|double the dose to catch up.||
1023|138|B|||
1023|139|R|STORAGE:  Store at room temperature away from light and moisture.||
1023|140|R|Do not store in the bathroom. Keep all medications away from||
1023|141|R|children and pets.||
1023|142|R|   Do not flush medications down the toilet or pour them into a||
1023|143|R|drain unless instructed to do so. Properly discard this product||
1023|144|R|when it is expired or no longer needed. Consult your pharmacist||
1023|145|R|or local waste disposal company.||
1023|146|B|||
1023|147|A|Information last revised October 2024.||
1023|148|A|Copyright(c) 2025 First Databank, Inc.||
1023|149|B|||
1027|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1027|002|Z|does NOT have all possible information about this product. This||
1027|003|Z|information does not assure that this product is safe, effective,||
1027|004|Z|or appropriate for you. This information is not individual||
1027|005|Z|medical advice and does not substitute for the advice of your||
1027|006|Z|health care professional. Always ask your health care||
1027|007|Z|professional for complete information about this product and your||
1027|008|Z|specific health needs.||
1027|009|B|||
1027|010|T|ESTRADIOL CYPIONATE - INJECTION||
1027|011|F|(ES-tra-DYE-ol sip-EYE-oh-nate)||
1027|012|B|||
1027|013|C|COMMON BRAND NAME(S): Depo-Estradiol||
1027|014|B|||
1027|015|W|WARNING:  Estrogens, either used alone or with another hormone||
1027|016|W|(progestin), have rarely caused very serious side effects.||
1027|017|W|Discuss the risks and benefits of hormone treatment with your||
1027|018|W|doctor. Estrogens should not be used to prevent heart disease or||
1027|019|W|dementia.||
1027|020|W|   Estrogens can increase the risk of cancer of the uterus||
1027|021|W|(endometrial cancer). Taking a progestin as directed by your||
1027|022|W|doctor can help decrease this risk. Tell your doctor right away||
1027|023|W|if you have any unusual vaginal bleeding.||
1027|024|W|   In postmenopausal women, estrogens, taken with or without a||
1027|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
1027|026|W|stroke, dementia, and serious blood clots. When used along with a||
1027|027|W|progestin, estrogens also increase the risk of heart disease||
1027|028|W|(such as heart attacks).||
1027|029|W|   The risk for serious side effects may depend on the dose of||
1027|030|W|estrogen and the length of time it is used. This medication||
1027|031|W|should be used at the lowest effective dose and for the shortest||
1027|032|W|amount of time. Discuss the use of this medication with your||
1027|033|W|doctor regularly (for example, every 3 to 6 months) to see if you||
1027|034|W|still need to use it. If you will be using this medication||
1027|035|W|long-term, you should have regular complete physical exams (for||
1027|036|W|example, once a year) as directed by your doctor. See also Notes||
1027|037|W|section.||
1027|038|B|||
1027|039|U|USES:  This medication is a hormone (estrogen). It is used by||
1027|040|U|women to help reduce symptoms of menopause (such as hot flashes,||
1027|041|U|vaginal dryness). These symptoms are caused by the body making||
1027|042|U|less estrogen. If you are using this medication to treat symptoms||
1027|043|U|only in and around the vagina, products applied directly inside||
1027|044|U|the vagina should be considered before medications that are taken||
1027|045|U|by mouth, absorbed through the skin, or injected. This medication||
1027|046|U|may also be used by women who are not able to produce enough||
1027|047|U|estrogen (for example, due to hypogonadism, primary ovarian||
1027|048|U|failure).||
1027|049|B|||
1027|050|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1027|051|H|from your pharmacist before you start using this medication and||
1027|052|H|each time you get a refill. If you have any questions, ask your||
1027|053|H|doctor or pharmacist.||
1027|054|H|   This medication is injected into a muscle as directed by your||
1027|055|H|doctor, usually every 3 to 4 weeks. The dosage is based on your||
1027|056|H|medical condition and response to treatment.||
1027|057|H|   If you are using this medication at home, learn all||
1027|058|H|preparation and usage instructions from your health care||
1027|059|H|professional. If stored at low temperatures, crystal may form in||
1027|060|H|the liquid. To dissolve these crystals, simply warm the product||
1027|061|H|to room temperature prior to use. Before using, check this||
1027|062|H|product for particles or discoloration. If either is present, do||
1027|063|H|not use the liquid. Learn how to store and discard medical||
1027|064|H|supplies safely.||
1027|065|H|   Use this medication regularly to get the most benefit from it.||
1027|066|H|To help you remember, mark your calendar with a reminder.||
1027|067|H|   Tell your doctor if your condition does not get better or if||
1027|068|H|it gets worse.||
1027|069|B|||
1027|070|S|SIDE EFFECTS:  See also Warning section.||
1027|071|S|   Nausea/vomiting, bloating, breast tenderness, headache, or||
1027|072|S|weight changes may occur. If any of these effects last or get||
1027|073|S|worse, tell your doctor or pharmacist promptly.||
1027|074|S|   Remember that this medication has been prescribed because your||
1027|075|S|doctor has judged that the benefit to you is greater than the||
1027|076|S|risk of side effects. Many people using this medication do not||
1027|077|S|have serious side effects.||
1027|078|S|   Tell your doctor right away if you have any serious side||
1027|079|S|effects, including: nausea/vomiting that doesn't stop,||
1027|080|S|mental/mood changes (such as depression, memory loss), breast||
1027|081|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
1027|082|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
1027|083|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
1027|084|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
1027|085|S|increased thirst/urination.||
1027|086|S|   This medication may rarely cause serious (sometimes fatal)||
1027|087|S|problems from blood clots (such as heart attack, stroke, blood||
1027|088|S|clots in the lungs or legs). Get medical help right away if you||
1027|089|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
1027|090|S|headaches, weakness on one side of the body, confusion, trouble||
1027|091|S|speaking, sudden vision changes, pain/swelling/warmth in the||
1027|092|S|groin/calf, shortness of breath/rapid breathing, sudden||
1027|093|S|dizziness/fainting.||
1027|094|S|   A very serious allergic reaction to this drug is rare.||
1027|095|S|However, get medical help right away if you notice any symptoms||
1027|096|S|of a serious allergic reaction, including: rash, itching/swelling||
1027|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1027|098|S|breathing.||
1027|099|S|   This is not a complete list of possible side effects. If you||
1027|100|S|notice other effects not listed above, contact your doctor or||
1027|101|S|pharmacist.||
1027|102|S|   In the US -||
1027|103|S|   Call your doctor for medical advice about side effects. You||
1027|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1027|105|S|www.fda.gov/medwatch.||
1027|106|S|   In Canada - Call your doctor for medical advice about side||
1027|107|S|effects. You may report side effects to Health Canada at||
1027|108|S|1-866-234-2345.||
1027|109|B|||
1027|110|P|PRECAUTIONS:  Before using estradiol cypionate, tell your doctor||
1027|111|P|or pharmacist if you are allergic to it; or if you have any other||
1027|112|P|allergies. This product may contain inactive ingredients, which||
1027|113|P|can cause allergic reactions or other problems. Talk to your||
1027|114|P|pharmacist for more details.||
1027|115|P|   Before using this medication, tell your doctor or pharmacist||
1027|116|P|your medical history, especially of: vaginal bleeding of unknown||
1027|117|P|cause, certain cancers (such as breast cancer, cancer of the||
1027|118|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
1027|119|P|heart attack), liver disease, kidney disease, family medical||
1027|120|P|history (especially breast lumps, cancer, blood clots), family or||
1027|121|P|personal history of a certain swelling disorder (angioedema),||
1027|122|P|blood clotting disorders (such as protein C or protein S||
1027|123|P|deficiency), high blood pressure, diabetes, high blood||
1027|124|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
1027|125|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
1027|126|P|calcium in the blood), a certain hormone problem||
1027|127|P|(hypoparathyroidism), uterus problems (such as fibroids,||
1027|128|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
1027|129|P|headaches, a certain blood disorder (porphyria), mental/mood||
1027|130|P|disorders (such as dementia, depression).||
1027|131|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
1027|132|P|further increases your risk of stroke, blood clots, high blood||
1027|133|P|pressure, and heart attack, especially in women older than 35.||
1027|134|P|   Tell your doctor if you just had or will be having surgery, or||
1027|135|P|if you will be confined to a chair or bed for a long time (such||
1027|136|P|as a long plane flight). These conditions increase your risk of||
1027|137|P|getting blood clots, especially if you are using an estrogen||
1027|138|P|product. You may need to stop this medication for a time or take||
1027|139|P|special precautions.||
1027|140|P|   This medication may cause blotchy, dark areas on your face and||
1027|141|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
1027|142|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
1027|143|P|wear protective clothing when outdoors.||
1027|144|P|   If you are nearsighted or wear contact lenses, you may develop||
1027|145|P|vision problems or trouble wearing your contact lenses. Contact||
1027|146|P|your eye doctor if these problems occur.||
1027|147|P|   Children may be more sensitive to the side effects of this||
1027|148|P|drug. It may affect their growth/development. Discuss the||
1027|149|P|possible effects of this medication with the doctor, and monitor||
1027|150|P|your child's growth periodically.||
1027|151|P|   This medication should not be used during pregnancy. If you||
1027|152|P|become pregnant or think you may be pregnant, tell your doctor||
1027|153|P|right away.||
1027|154|P|   This medication passes into breast milk. Consult your doctor||
1027|155|P|before breastfeeding.||
1027|156|B|||
1027|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1027|158|I|medications work or increase your risk for serious side effects.||
1027|159|I|This document does not contain all possible drug interactions.||
1027|160|I|Keep a list of all the products you use (including||
1027|161|I|prescription/nonprescription drugs and herbal products) and share||
1027|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
1027|163|I|the dosage of any medicines without your doctor's approval.||
1027|164|I|   Some products that may interact with this drug include:||
1027|165|I|aromatase inhibitors (such as anastrozole, exemestane,||
1027|166|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
1027|167|I|tamoxifen, toremifene, tranexamic acid.||
1027|168|I|   This medication may interfere with certain lab tests (such as||
1027|169|I|metyrapone test), possibly causing false test results. Make sure||
1027|170|I|lab personnel and all your doctors know you use this drug.||
1027|171|B|||
1027|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1027|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1027|174|O|poison control center right away. US residents can call||
1027|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1027|176|O|Symptoms of overdose may include: severe nausea/vomiting, unusual||
1027|177|O|vaginal bleeding.||
1027|178|B|||
1027|179|N|NOTES:  Do not share this medication with others.||
1027|180|N|   Regular complete physical exams which include lab and/or||
1027|181|N|medical tests (such as blood pressure, breast exam/mammogram,||
1027|182|N|pelvic exam, Pap smear) should be done while you are using this||
1027|183|N|medication. Follow your doctor's instructions for examining your||
1027|184|N|breasts, and report any lumps right away. Keep all medical and||
1027|185|N|lab appointments. Consult your doctor for more details.||
1027|186|N|   Preventing or controlling high blood pressure, high||
1027|187|N|cholesterol, and diabetes can help to reduce your chances of||
1027|188|N|heart disease and stroke. Lifestyle changes that can help to||
1027|189|N|control or prevent these diseases include reducing stress, eating||
1027|190|N|a low fat/salt diet, losing weight if overweight, exercising||
1027|191|N|regularly, and stopping smoking. Keep your mind active with||
1027|192|N|mental exercises (such as reading, solving crossword puzzles) to||
1027|193|N|help prevent dementia. Talk to your doctor about lifestyle||
1027|194|N|changes that might benefit you.||
1027|195|N|   Lifestyle changes that may help reduce hot flashes include||
1027|196|N|stopping smoking, dressing lightly or in layers,||
1027|197|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
1027|198|N|reducing stress, and exercising regularly.||
1027|199|B|||
1027|200|D|MISSED DOSE:  It is important to get each dose of this medication||
1027|201|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1027|202|D|right away for a new dosing schedule. Do not double the dose to||
1027|203|D|catch up.||
1027|204|B|||
1027|205|R|STORAGE:  Store at room temperature. Keep all medications away||
1027|206|R|from children and pets.||
1027|207|R|   Do not flush medications down the toilet or pour them into a||
1027|208|R|drain unless instructed to do so. Properly discard this product||
1027|209|R|when it is expired or no longer needed. Consult your pharmacist||
1027|210|R|or local waste disposal company.||
1027|211|B|||
1027|212|A|Information last revised December 2024.||
1027|213|A|Copyright(c) 2025 First Databank, Inc.||
1027|214|B|||
1028|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1028|002|Z|does NOT have all possible information about this product. This||
1028|003|Z|information does not assure that this product is safe, effective,||
1028|004|Z|or appropriate for you. This information is not individual||
1028|005|Z|medical advice and does not substitute for the advice of your||
1028|006|Z|health care professional. Always ask your health care||
1028|007|Z|professional for complete information about this product and your||
1028|008|Z|specific health needs.||
1028|009|B|||
1028|010|T|ZILEUTON EXTENDED-RELEASE - ORAL||
1028|011|F|(zye-LOO-ton)||
1028|012|B|||
1028|013|C|COMMON BRAND NAME(S): Zyflo CR||
1028|014|B|||
1028|015|U|USES:  Zileuton is used to control and prevent symptoms (such as||
1028|016|U|wheezing and shortness of breath) caused by asthma. Controlling||
1028|017|U|symptoms of asthma helps you maintain your normal activities and||
1028|018|U|cuts down on time lost from work or school.||
1028|019|U|   This medication must be used regularly to be effective. It||
1028|020|U|does not work right away and should not be used to relieve sudden||
1028|021|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
1028|022|U|inhaler (such as albuterol, salbutamol) as prescribed.||
1028|023|U|   This drug is not recommended for use in children younger than||
1028|024|U|12 years due to possible risk of liver problems.||
1028|025|B|||
1028|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1028|027|H|from your pharmacist before you start taking zileuton and each||
1028|028|H|time you get a refill. If you have any questions, ask your doctor||
1028|029|H|or pharmacist.||
1028|030|H|   Take this medication by mouth with food as directed by your||
1028|031|H|doctor, usually 2 times daily (within 1 hour after the morning||
1028|032|H|and evening meal). Swallow the tablets whole. Do not crush, chew,||
1028|033|H|or split the tablets. Doing so can release all of the drug at||
1028|034|H|once, increasing the risk of side effects.||
1028|035|H|   Use this medication regularly to get the most benefit from it.||
1028|036|H|To help you remember, take it at the same times each day. Keep||
1028|037|H|taking this medication even if you feel well. Do not increase||
1028|038|H|your dose, use this drug more often, or stop using it without||
1028|039|H|first consulting your doctor.||
1028|040|H|   Get medical help right away if your asthma symptoms worsen or||
1028|041|H|if you are using your quick-relief inhaler more than usual or||
1028|042|H|more often than prescribed.||
1028|043|B|||
1028|044|S|SIDE EFFECTS:  Nausea or diarrhea may occur. If either of these||
1028|045|S|effects lasts or gets worse, tell your doctor or pharmacist||
1028|046|S|promptly.||
1028|047|S|   Remember that this medication has been prescribed because your||
1028|048|S|doctor has judged that the benefit to you is greater than the||
1028|049|S|risk of side effects. Many people using this medication do not||
1028|050|S|have serious side effects.||
1028|051|S|   Tell your doctor right away if you have any serious side||
1028|052|S|effects, including: symptoms of liver disease (such as||
1028|053|S|nausea/vomiting that doesn't stop, loss of appetite,||
1028|054|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1028|055|S|mental/mood changes (such as trouble sleeping, agitation,||
1028|056|S|hallucinations, depression, thoughts of suicide).||
1028|057|S|   A very serious allergic reaction to this drug is rare.||
1028|058|S|However, get medical help right away if you notice any symptoms||
1028|059|S|of a serious allergic reaction, including: rash, itching/swelling||
1028|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1028|061|S|breathing.||
1028|062|S|   This is not a complete list of possible side effects. If you||
1028|063|S|notice other effects not listed above, contact your doctor or||
1028|064|S|pharmacist.||
1028|065|S|   In the US -||
1028|066|S|   Call your doctor for medical advice about side effects. You||
1028|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1028|068|S|www.fda.gov/medwatch.||
1028|069|S|   In Canada - Call your doctor for medical advice about side||
1028|070|S|effects. You may report side effects to Health Canada at||
1028|071|S|1-866-234-2345.||
1028|072|B|||
1028|073|P|PRECAUTIONS:  Before taking zileuton, tell your doctor or||
1028|074|P|pharmacist if you are allergic to it; or if you have any other||
1028|075|P|allergies. This product may contain inactive ingredients, which||
1028|076|P|can cause allergic reactions or other problems. Talk to your||
1028|077|P|pharmacist for more details.||
1028|078|P|   Before using this medication, tell your doctor or pharmacist||
1028|079|P|your medical history, especially of: liver disease, alcohol use.||
1028|080|P|   Before having surgery, tell your doctor or dentist about all||
1028|081|P|the products you use (including prescription drugs,||
1028|082|P|nonprescription drugs, and herbal products).||
1028|083|P|   Older women may be at greater risk for liver problems while||
1028|084|P|using this drug.||
1028|085|P|   During pregnancy, this medication should be used only when||
1028|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
1028|087|P|   It is unknown if this medication passes into breast milk.||
1028|088|P|Consult your doctor before breastfeeding.||
1028|089|B|||
1028|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1028|091|I|medications work or increase your risk for serious side effects.||
1028|092|I|This document does not contain all possible drug interactions.||
1028|093|I|Keep a list of all the products you use (including||
1028|094|I|prescription/nonprescription drugs and herbal products) and share||
1028|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
1028|096|I|the dosage of any medicines without your doctor's approval.||
1028|097|I|   This medication can slow down the removal of other medications||
1028|098|I|from your body, which may affect how they work. Examples of||
1028|099|I|affected drugs include fezolinetant, pimozide, among others.||
1028|100|B|||
1028|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1028|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1028|103|O|poison control center right away. US residents can call||
1028|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1028|105|B|||
1028|106|N|NOTES:  Do not share this medication with others.||
1028|107|N|   Lab and/or medical tests (such as liver/lung function) should||
1028|108|N|be done while you are taking this medication. Keep all medical||
1028|109|N|and lab appointments. Consult your doctor for more details.||
1028|110|N|   Avoid substances that can worsen breathing problems by causing||
1028|111|N|irritation or allergic reaction, such as smoke, pollen, pet||
1028|112|N|dander, dust, and mold.||
1028|113|B|||
1028|114|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1028|115|D|next dose at the regular time. Do not double the dose to catch||
1028|116|D|up.||
1028|117|B|||
1028|118|R|STORAGE:  Store at room temperature away from light and moisture.||
1028|119|R|Do not store in the bathroom. Keep all medications away from||
1028|120|R|children and pets.||
1028|121|R|   Do not flush medications down the toilet or pour them into a||
1028|122|R|drain unless instructed to do so. Properly discard this product||
1028|123|R|when it is expired or no longer needed. Consult your pharmacist||
1028|124|R|or local waste disposal company.||
1028|125|B|||
1028|126|M|MEDICAL ALERT:  Your condition can cause complications in a||
1028|127|M|medical emergency. For information about enrolling in MedicAlert,||
1028|128|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1028|129|B|||
1028|130|A|Information last revised May 2024.||
1028|131|A|Copyright(c) 2025 First Databank, Inc.||
1028|132|B|||
1029|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1029|002|Z|does NOT have all possible information about this product. This||
1029|003|Z|information does not assure that this product is safe, effective,||
1029|004|Z|or appropriate for you. This information is not individual||
1029|005|Z|medical advice and does not substitute for the advice of your||
1029|006|Z|health care professional. Always ask your health care||
1029|007|Z|professional for complete information about this product and your||
1029|008|Z|specific health needs.||
1029|009|B|||
1029|010|T|AMLODIPINE/OLMESARTAN - ORAL||
1029|011|F|(am-LOE-di-peen/OL-me-SAR-tan)||
1029|012|B|||
1029|013|C|COMMON BRAND NAME(S): Azor||
1029|014|B|||
1029|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
1029|016|W|unborn baby if used during pregnancy. It is important to prevent||
1029|017|W|pregnancy while taking this medication. Consult your doctor for||
1029|018|W|more details and to discuss the use of reliable forms of birth||
1029|019|W|control while taking this medication. If you are planning||
1029|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
1029|021|W|your doctor right away.||
1029|022|B|||
1029|023|U|USES:  This product is used to treat high blood pressure||
1029|024|U|(hypertension). Lowering high blood pressure helps prevent||
1029|025|U|strokes, heart attacks, and kidney problems.||
1029|026|U|   This product contains 2 medications: amlodipine and||
1029|027|U|olmesartan. They both work by relaxing blood vessels so blood can||
1029|028|U|flow more easily. Amlodipine is a calcium channel blocker and||
1029|029|U|olmesartan is an angiotensin receptor blocker (ARB).||
1029|030|B|||
1029|031|H|HOW TO USE:  Take this medication by mouth with or without food||
1029|032|H|as directed by your doctor, usually once daily.||
1029|033|H|   The dosage is based on your medical condition and response to||
1029|034|H|treatment. To reduce your risk of side effects, your doctor may||
1029|035|H|direct you to start this medication at a low dose and gradually||
1029|036|H|increase your dose. Follow your doctor's instructions carefully.||
1029|037|H|   If you also take certain drugs to lower your cholesterol (bile||
1029|038|H|acid-binding resins such as cholestyramine, colesevelam,||
1029|039|H|colestipol), take amlodipine/olmesartan at least 4 hours before||
1029|040|H|any of these medications.||
1029|041|H|   Take this medication regularly to get the most benefit from||
1029|042|H|it. To help you remember, take it at the same time each day. Keep||
1029|043|H|taking this medication even if you feel well. Most people with||
1029|044|H|high blood pressure do not feel sick. It may take up to 2 weeks||
1029|045|H|before you get the full benefit of this drug.||
1029|046|H|   Tell your doctor if your condition does not get better or if||
1029|047|H|it gets worse (your blood pressure readings remain high or||
1029|048|H|increase).||
1029|049|B|||
1029|050|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
1029|051|S|body adjusts to the medication. Headache or flushing may also||
1029|052|S|occur. If any of these effects last or get worse, tell your||
1029|053|S|doctor or pharmacist promptly.||
1029|054|S|   To reduce the risk of dizziness and lightheadedness, get up||
1029|055|S|slowly when rising from a sitting or lying position.||
1029|056|S|   Remember that this medication has been prescribed because your||
1029|057|S|doctor has judged that the benefit to you is greater than the||
1029|058|S|risk of side effects. Many people using this medication do not||
1029|059|S|have serious side effects.||
1029|060|S|   Tell your doctor right away if you have any serious side||
1029|061|S|effects, including: diarrhea that is severe or doesn't stop,||
1029|062|S|swelling hands/ankles/feet, fainting, fast heartbeat, signs of||
1029|063|S|kidney problems (such as change in the amount of urine), symptoms||
1029|064|S|of a high potassium blood level (such as muscle weakness,||
1029|065|S|slow/irregular heartbeat).||
1029|066|S|   Some people who already have severe heart disease may rarely||
1029|067|S|develop worsening chest pain or a heart attack after starting||
1029|068|S|this medication or increasing the dose. Get medical help right||
1029|069|S|away if you experience: worsening chest pain, symptoms of a heart||
1029|070|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
1029|071|S|unusual sweating).||
1029|072|S|   A very serious allergic reaction to this drug is rare.||
1029|073|S|However, get medical help right away if you notice any symptoms||
1029|074|S|of a serious allergic reaction, including: rash, itching/swelling||
1029|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1029|076|S|breathing.||
1029|077|S|   This is not a complete list of possible side effects. If you||
1029|078|S|notice other effects not listed above, contact your doctor or||
1029|079|S|pharmacist.||
1029|080|S|   In the US -||
1029|081|S|   Call your doctor for medical advice about side effects. You||
1029|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1029|083|S|www.fda.gov/medwatch.||
1029|084|S|   In Canada - Call your doctor for medical advice about side||
1029|085|S|effects. You may report side effects to Health Canada at||
1029|086|S|1-866-234-2345.||
1029|087|B|||
1029|088|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1029|089|P|pharmacist if you are allergic to either amlodipine or||
1029|090|P|olmesartan, or if you have any other allergies. This product may||
1029|091|P|contain inactive ingredients, which can cause allergic reactions||
1029|092|P|or other problems. Talk to your pharmacist for more details.||
1029|093|P|   Before using this medication, tell your doctor or pharmacist||
1029|094|P|your medical history, especially of: kidney disease, liver||
1029|095|P|disease, a certain heart valve condition (aortic stenosis),||
1029|096|P|dehydration, high level of potassium in the blood.||
1029|097|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1029|098|P|can make you more dizzy. Do not drive, use machinery, or do||
1029|099|P|anything that needs alertness until you can do it safely. Limit||
1029|100|P|alcoholic beverages. Talk to your doctor if you are using||
1029|101|P|marijuana (cannabis).||
1029|102|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1029|103|P|and cause you to feel lightheaded. Tell your doctor if you have||
1029|104|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1029|105|P|of fluids unless your doctor tells you not to.||
1029|106|P|   This product may increase your potassium levels. Before using||
1029|107|P|potassium supplements or salt substitutes that contain potassium,||
1029|108|P|consult your doctor or pharmacist.||
1029|109|P|   Before having surgery, tell your doctor or dentist about all||
1029|110|P|the products you use (including prescription drugs,||
1029|111|P|nonprescription drugs, and herbal products).||
1029|112|P|   Older adults may be more sensitive to the side effects of this||
1029|113|P|drug, especially dizziness and change in the amount of urine||
1029|114|P|(kidney problems).||
1029|115|P|   Tell your doctor if you are pregnant or plan to become||
1029|116|P|pregnant. You should not become pregnant while using this||
1029|117|P|medication. Olmesartan may harm an unborn baby. If you become||
1029|118|P|pregnant, talk to your doctor right away about the risks and||
1029|119|P|benefits of this medication. See also Warning section.||
1029|120|P|   Amlodipine passes into breast milk. It is unknown if||
1029|121|P|olmesartan passes into breast milk. Consult your doctor before||
1029|122|P|breastfeeding.||
1029|123|B|||
1029|124|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
1029|125|I|   Drug interactions may change how your medications work or||
1029|126|I|increase your risk for serious side effects. This document does||
1029|127|I|not contain all possible drug interactions. Keep a list of all||
1029|128|I|the products you use (including prescription/nonprescription||
1029|129|I|drugs and herbal products) and share it with your doctor and||
1029|130|I|pharmacist. Do not start, stop, or change the dosage of any||
1029|131|I|medicines without your doctor's approval.||
1029|132|I|   Some products that may interact with this drug include:||
1029|133|I|aliskiren, lithium, drugs that may increase the level of||
1029|134|I|potassium in the blood (such as sparsentan, ACE inhibitors||
1029|135|I|including benazepril/lisinopril, birth control pills containing||
1029|136|I|drospirenone).||
1029|137|I|   Some products have ingredients that could raise your blood||
1029|138|I|pressure. Tell your pharmacist what products you are using, and||
1029|139|I|ask how to use them safely (especially cough-and-cold products,||
1029|140|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1029|141|B|||
1029|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1029|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1029|144|O|poison control center right away. US residents can call||
1029|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1029|146|O|Symptoms of overdose may include: severe dizziness, fainting.||
1029|147|B|||
1029|148|N|NOTES:  Do not share this medication with others.||
1029|149|N|   Lifestyle changes that may help this medication work better||
1029|150|N|include exercising, stopping smoking, and eating a||
1029|151|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1029|152|N|details.||
1029|153|N|   Lab and/or medical tests (such as potassium levels, kidney||
1029|154|N|function) should be done while you are taking this medication.||
1029|155|N|Keep all medical and lab appointments. Consult your doctor for||
1029|156|N|more details.||
1029|157|N|   Have your blood pressure checked regularly while taking this||
1029|158|N|medication. Learn how to monitor your own blood pressure at home,||
1029|159|N|and share the results with your doctor.||
1029|160|B|||
1029|161|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1029|162|D|remember. If it is near the time of the next dose, skip the||
1029|163|D|missed dose. Take your next dose at the regular time. Do not||
1029|164|D|double the dose to catch up.||
1029|165|B|||
1029|166|R|STORAGE:  Store at room temperature away from light and moisture.||
1029|167|R|Do not store in the bathroom. Keep all medications away from||
1029|168|R|children and pets.||
1029|169|R|   Do not flush medications down the toilet or pour them into a||
1029|170|R|drain unless instructed to do so. Properly discard this product||
1029|171|R|when it is expired or no longer needed. Consult your pharmacist||
1029|172|R|or local waste disposal company.||
1029|173|B|||
1029|174|A|Information last revised May 2024.||
1029|175|A|Copyright(c) 2025 First Databank, Inc.||
1029|176|B|||
1031|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1031|002|Z|does NOT have all possible information about this product. This||
1031|003|Z|information does not assure that this product is safe, effective,||
1031|004|Z|or appropriate for you. This information is not individual||
1031|005|Z|medical advice and does not substitute for the advice of your||
1031|006|Z|health care professional. Always ask your health care||
1031|007|Z|professional for complete information about this product and your||
1031|008|Z|specific health needs.||
1031|009|B|||
1031|010|T|LANREOTIDE DEPOT - INJECTION||
1031|011|F|(lan-REE-oh-tide)||
1031|012|B|||
1031|013|C|COMMON BRAND NAME(S): Somatuline||
1031|014|B|||
1031|015|U|USES:  This medication is a long-acting form of lanreotide.||
1031|016|U|Lanreotide is used to treat a condition called acromegaly that||
1031|017|U|occurs when the body makes too much of a certain natural||
1031|018|U|substance called growth hormone. It is used when surgery or||
1031|019|U|radiation treatment have not been fully successful or cannot be||
1031|020|U|used. Treating acromegaly helps reduce the risk of serious||
1031|021|U|problems such as diabetes and heart disease. Lanreotide works by||
1031|022|U|decreasing the amount of growth hormone to normal levels.||
1031|023|U|   This drug is not a cure for acromegaly. It is used for the||
1031|024|U|long-term treatment of this condition.||
1031|025|U|   This medication is also used to treat certain cancer or tumors||
1031|026|U|of the stomach, intestines, or pancreas. It may help to slow down||
1031|027|U|the growth of these tumors. Lanreotide is also used to treat||
1031|028|U|carcinoid syndrome. It may help reduce the need to use another||
1031|029|U|medication to treat diarrhea or flushing caused by carcinoid||
1031|030|U|syndrome.||
1031|031|B|||
1031|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1031|033|H|from your pharmacist before you start using lanreotide and before||
1031|034|H|each monthly injection. If you have any questions, ask your||
1031|035|H|doctor or pharmacist.||
1031|036|H|   This medication is given by injection under the skin by a||
1031|037|H|health care professional. It is given as directed by your doctor,||
1031|038|H|usually once every 4 weeks. The injection is given in the||
1031|039|H|buttocks. To reduce irritation from the injection, your doctor||
1031|040|H|will alternate between the left and right buttock with each dose.||
1031|041|H|The dosage is based on your medical condition and response to||
1031|042|H|treatment.||
1031|043|H|   Use this medication regularly to get the most benefit from it.||
1031|044|H|To help you remember, mark your calendar with a reminder.||
1031|045|H|   Tell your doctor if your condition does not get better or if||
1031|046|H|it gets worse.||
1031|047|B|||
1031|048|S|SIDE EFFECTS:  Headache, muscle/joint pain, dizziness, nausea,||
1031|049|S|vomiting, diarrhea, constipation, stomach upset, gas, or bloating||
1031|050|S|may occur. Pain and irritation at the injection site may also||
1031|051|S|occur. If any of these effects last or get worse, tell your||
1031|052|S|doctor or pharmacist promptly.||
1031|053|S|   Remember that this medication has been prescribed because your||
1031|054|S|doctor has judged that the benefit to you is greater than the||
1031|055|S|risk of side effects. Many people using this medication do not||
1031|056|S|have serious side effects.||
1031|057|S|   Tell your doctor right away if you have any serious side||
1031|058|S|effects, including: signs of gallbladder problems/gallstones||
1031|059|S|(such as fever, stomach/abdominal pain, severe nausea/vomiting,||
1031|060|S|yellowing eyes/skin, unexplained pain in the back/right||
1031|061|S|shoulder), signs of an underactive thyroid (such as unexplained||
1031|062|S|weight gain, cold intolerance, severe constipation,||
1031|063|S|unusual/extreme tiredness, growth/lump/swelling on the front of||
1031|064|S|the neck), slow heartbeat, mental/mood changes (such as||
1031|065|S|depression), weight loss, change in stool color.||
1031|066|S|   This medication may rarely cause changes in blood sugar,||
1031|067|S|especially if you have diabetes. Symptoms of high blood sugar||
1031|068|S|include increased thirst and urination. Symptoms of low blood||
1031|069|S|sugar include nervousness, shakiness, sweating, fast heartbeat,||
1031|070|S|and hunger. Tell your doctor right away if you experience||
1031|071|S|symptoms of high or low blood sugar while using this medication.||
1031|072|S|Monitor your blood sugar levels as directed by your doctor. Your||
1031|073|S|doctor may need to adjust your diabetes medications.||
1031|074|S|   This medication may raise your blood pressure. Check your||
1031|075|S|blood pressure regularly and tell your doctor if the results are||
1031|076|S|high.||
1031|077|S|   A very serious allergic reaction to this drug is rare.||
1031|078|S|However, get medical help right away if you notice any symptoms||
1031|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1031|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1031|081|S|breathing.||
1031|082|S|   This is not a complete list of possible side effects. If you||
1031|083|S|notice other effects not listed above, contact your doctor or||
1031|084|S|pharmacist.||
1031|085|S|   In the US -||
1031|086|S|   Call your doctor for medical advice about side effects. You||
1031|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1031|088|S|www.fda.gov/medwatch.||
1031|089|S|   In Canada - Call your doctor for medical advice about side||
1031|090|S|effects. You may report side effects to Health Canada at||
1031|091|S|1-866-234-2345.||
1031|092|B|||
1031|093|P|PRECAUTIONS:  Before using lanreotide, tell your doctor or||
1031|094|P|pharmacist if you are allergic to it; or if you have any other||
1031|095|P|allergies. This product may contain inactive ingredients (such as||
1031|096|P|dry natural rubber/latex found in the packaging), which can cause||
1031|097|P|allergic reactions or other problems. Talk to your pharmacist for||
1031|098|P|more details.||
1031|099|P|   Before using this medication, tell your doctor or pharmacist||
1031|100|P|your medical history, especially of: kidney disease, liver||
1031|101|P|disease, diabetes, heart problems (such as slow heartbeat, high||
1031|102|P|blood pressure, heart valve problems), thyroid problems,||
1031|103|P|gallbladder problems (such as gallstones).||
1031|104|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1031|105|P|can make you more dizzy. Do not drive, use machinery, or do||
1031|106|P|anything that needs alertness until you can do it safely. Limit||
1031|107|P|alcoholic beverages. Talk to your doctor if you are using||
1031|108|P|marijuana (cannabis).||
1031|109|P|   Before having surgery, tell your doctor or dentist about all||
1031|110|P|the products you use (including prescription drugs,||
1031|111|P|nonprescription drugs, and herbal products).||
1031|112|P|   During pregnancy, this medication should be used only when||
1031|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
1031|114|P|   It is unknown if this drug passes into breast milk. Consult||
1031|115|P|your doctor before breastfeeding.||
1031|116|B|||
1031|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1031|118|I|medications work or increase your risk for serious side effects.||
1031|119|I|This document does not contain all possible drug interactions.||
1031|120|I|Keep a list of all the products you use (including||
1031|121|I|prescription/nonprescription drugs and herbal products) and share||
1031|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
1031|123|I|the dosage of any medicines without your doctor's approval.||
1031|124|I|   A product that may interact with this drug is: pegvisomant.||
1031|125|B|||
1031|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1031|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1031|128|O|poison control center right away. US residents can call||
1031|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1031|130|B|||
1031|131|N|NOTES:  Lab and/or medical tests (such as growth hormone levels,||
1031|132|N|blood glucose tests, thyroid function, blood pressure, heart||
1031|133|N|rate) should be done while you are using this medication. Keep||
1031|134|N|all medical and lab appointments. Consult your doctor for more||
1031|135|N|details.||
1031|136|B|||
1031|137|D|MISSED DOSE:  It is important to get each dose of this medication||
1031|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1031|139|D|right away for a new dosing schedule.||
1031|140|B|||
1031|141|R|STORAGE:  Not applicable. This medication is given in a clinic||
1031|142|R|and will not be stored at home.||
1031|143|B|||
1031|144|A|Information last revised October 2024.||
1031|145|A|Copyright(c) 2025 First Databank, Inc.||
1031|146|B|||
1032|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1032|002|Z|does NOT have all possible information about this product. This||
1032|003|Z|information does not assure that this product is safe, effective,||
1032|004|Z|or appropriate for you. This information is not individual||
1032|005|Z|medical advice and does not substitute for the advice of your||
1032|006|Z|health care professional. Always ask your health care||
1032|007|Z|professional for complete information about this product and your||
1032|008|Z|specific health needs.||
1032|009|B|||
1032|010|T|TRAVOPROST SOLUTION - OPHTHALMIC||
1032|011|F|(TRA-voh-prost)||
1032|012|B|||
1032|013|C|COMMON BRAND NAME(S): Travatan||
1032|014|B|||
1032|015|U|USES:  Travoprost is used to treat high pressure inside the eye||
1032|016|U|due to glaucoma (open-angle type) or other eye diseases (such as||
1032|017|U|ocular hypertension). Lowering high pressure inside the eye can||
1032|018|U|help prevent blindness. This medication works by regulating the||
1032|019|U|flow of fluid within the eye to maintain a normal pressure.||
1032|020|B|||
1032|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1032|022|H|from your pharmacist before you start using travoprost and each||
1032|023|H|time you get a refill. If you have any questions, ask your doctor||
1032|024|H|or pharmacist.||
1032|025|H|   Use this medication in the affected eye(s) as directed by your||
1032|026|H|doctor, usually once a day in the evening. Do not use travoprost||
1032|027|H|more often because it will not work as well.||
1032|028|H|   To apply eye drops, wash your hands first. To avoid||
1032|029|H|contamination, do not touch the dropper tip or let it touch your||
1032|030|H|eye or any other surface.||
1032|031|H|   Remove contact lenses before using this medication if your||
1032|032|H|brand contains the preservative benzalkonium chloride. This||
1032|033|H|preservative can be absorbed by contact lenses. Wait at least 15||
1032|034|H|minutes after using this medication before putting your lenses||
1032|035|H|back in.||
1032|036|H|   Tilt your head back, look upward and pull down the lower||
1032|037|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1032|038|H|and place one drop into the pouch. Look downward and gently close||
1032|039|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
1032|040|H|your eye (near the nose) and apply gentle pressure. This will||
1032|041|H|prevent the medication from draining out. Try not to blink and do||
1032|042|H|not rub your eye. Repeat these steps for your other eye if so||
1032|043|H|directed.||
1032|044|H|   Do not rinse the dropper. Replace the dropper cap after each||
1032|045|H|use.||
1032|046|H|   If you are using another kind of eye medication (such as drops||
1032|047|H|or ointments), wait at least 5 minutes before applying other||
1032|048|H|medications. Use eye drops before eye ointments to allow the eye||
1032|049|H|drops to enter the eye.||
1032|050|H|   Wait several minutes for your vision to clear before driving||
1032|051|H|or operating machinery.||
1032|052|H|   Use this medication regularly in order to get the most benefit||
1032|053|H|from it. Remember to use it at the same time each day. Keep using||
1032|054|H|travoprost even if you feel well. Most people with glaucoma or||
1032|055|H|high pressure in the eye do not have symptoms.||
1032|056|B|||
1032|057|S|SIDE EFFECTS:  Blurred vision, eye redness/discomfort/itching,||
1032|058|S|feeling as if something is in your eye, dry eyes, tearing, eyelid||
1032|059|S|crusting, increase in eyelash number/length/thickness, darkening||
1032|060|S|of the eyelashes and eyelids, eyelid changes, or increased||
1032|061|S|sensitivity to light may occur. If any of these effects last or||
1032|062|S|get worse, notify your doctor or pharmacist promptly.||
1032|063|S|   This medication may slowly (over months to years) cause brown||
1032|064|S|discoloration of the colored portion of the eye (iris). If you||
1032|065|S|are using travoprost in only one eye, only that iris may change||
1032|066|S|color. This color change may be permanent, but the long-term||
1032|067|S|effects are uncertain. Notify your doctor if this occurs and||
1032|068|S|schedule regular eye exams to monitor it.||
1032|069|S|   Remember that this medication has been prescribed because your||
1032|070|S|doctor has judged that the benefit to you is greater than the||
1032|071|S|risk of side effects. Many people using this medication do not||
1032|072|S|have serious side effects.||
1032|073|S|   Tell your doctor right away if you have any serious side||
1032|074|S|effects, including: vision changes, eye pain, swelling/redness of||
1032|075|S|the eyelids.||
1032|076|S|   A very serious allergic reaction to this drug is rare.||
1032|077|S|However, get medical help right away if you notice any symptoms||
1032|078|S|of a serious allergic reaction, including: rash, itching/swelling||
1032|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1032|080|S|breathing.||
1032|081|S|   This is not a complete list of possible side effects. If you||
1032|082|S|notice other effects not listed above, contact your doctor or||
1032|083|S|pharmacist.||
1032|084|S|   In the US -||
1032|085|S|   Call your doctor for medical advice about side effects. You||
1032|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1032|087|S|www.fda.gov/medwatch.||
1032|088|S|   In Canada - Call your doctor for medical advice about side||
1032|089|S|effects. You may report side effects to Health Canada at||
1032|090|S|1-866-234-2345.||
1032|091|B|||
1032|092|P|PRECAUTIONS:  Before using travoprost, tell your doctor or||
1032|093|P|pharmacist if you are allergic to it; or to similar drugs (such||
1032|094|P|as bimatoprost, latanoprost); or if you have any other allergies.||
1032|095|P|This product may contain inactive ingredients (such as||
1032|096|P|preservatives like benzalkonium chloride found in some brands),||
1032|097|P|which can cause allergic reactions or other problems. Talk to||
1032|098|P|your pharmacist for more details.||
1032|099|P|   Before using this medication, tell your doctor or pharmacist||
1032|100|P|your medical history, especially of: other eye problems (such as||
1032|101|P|macular edema, iritis, uveitis, lens extraction/aphakia).||
1032|102|P|   If you develop an eye infection or injury, or have eye||
1032|103|P|surgery, check with your doctor about the continued use of your||
1032|104|P|current bottle of travoprost. You may be advised to start using a||
1032|105|P|new bottle.||
1032|106|P|   After you apply this drug, your vision may become temporarily||
1032|107|P|blurred. Do not drive, use machinery, or do anything that needs||
1032|108|P|clear vision until you can do it safely.||
1032|109|P|   During pregnancy, this medication should be used only when||
1032|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
1032|111|P|   It is unknown if this medication passes into breast milk.||
1032|112|P|Consult your doctor before breastfeeding.||
1032|113|B|||
1032|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1032|115|I|medications work or increase your risk for serious side effects.||
1032|116|I|This document does not contain all possible drug interactions.||
1032|117|I|Keep a list of all the products you use (including||
1032|118|I|prescription/nonprescription drugs and herbal products) and share||
1032|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
1032|120|I|the dosage of any medicines without your doctor's approval.||
1032|121|I|   Some products that may interact with this drug are: eyelash||
1032|122|I|treatment (such as topically applied bimatoprost).||
1032|123|B|||
1032|124|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1032|125|O|has overdosed and has serious symptoms such as passing out or||
1032|126|O|trouble breathing, call 911. Otherwise, call a poison control||
1032|127|O|center right away. US residents can call 1-800-222-1222. Canada||
1032|128|O|residents can call 1-844-764-7669.||
1032|129|B|||
1032|130|N|NOTES:  Do not share this medication with others.||
1032|131|N|   Lab and/or medical tests (such as eye exams) should be done||
1032|132|N|while you are using this medication. Keep all medical and lab||
1032|133|N|appointments. Consult your doctor for more details.||
1032|134|B|||
1032|135|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1032|136|D|If it is near the time of the next dose, skip the missed dose.||
1032|137|D|Use your next dose at the regular time. Do not double the dose to||
1032|138|D|catch up.||
1032|139|B|||
1032|140|R|STORAGE:  Store in the refrigerator or at room temperature. Keep||
1032|141|R|all medications away from children and pets.||
1032|142|R|   Do not flush medications down the toilet or pour them into a||
1032|143|R|drain unless instructed to do so. Properly discard this product||
1032|144|R|when it is expired or no longer needed. Consult your pharmacist||
1032|145|R|or local waste disposal company.||
1032|146|B|||
1032|147|A|Information last revised May 2024.||
1032|148|A|Copyright(c) 2025 First Databank, Inc.||
1032|149|B|||
1033|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1033|002|Z|does NOT have all possible information about this product. This||
1033|003|Z|information does not assure that this product is safe, effective,||
1033|004|Z|or appropriate for you. This information is not individual||
1033|005|Z|medical advice and does not substitute for the advice of your||
1033|006|Z|health care professional. Always ask your health care||
1033|007|Z|professional for complete information about this product and your||
1033|008|Z|specific health needs.||
1033|009|B|||
1033|010|T|FAMOTIDINE SUSPENSION - ORAL||
1033|011|F|(fa-MOE-ti-deen)||
1033|012|B|||
1033|013|C|COMMON BRAND NAME(S): Pepcid||
1033|014|B|||
1033|015|U|USES:  Famotidine is used to treat ulcers of the stomach and||
1033|016|U|intestines and to prevent intestinal ulcers from coming back||
1033|017|U|after they have healed. This medication is also used to treat||
1033|018|U|certain stomach and throat (esophagus) problems (such as erosive||
1033|019|U|esophagitis, gastroesophageal reflux disease-GERD,||
1033|020|U|Zollinger-Ellison syndrome). It works by decreasing the amount of||
1033|021|U|acid your stomach makes. It relieves symptoms such as cough that||
1033|022|U|doesn't go away, stomach pain, heartburn, and difficulty||
1033|023|U|swallowing. Famotidine belongs to a class of drugs known as H2||
1033|024|U|blockers.||
1033|025|B|||
1033|026|H|HOW TO USE:  Take this medication by mouth with or without food||
1033|027|H|as directed by your doctor, usually once or twice a day. If you||
1033|028|H|are taking this medication once daily, it is usually taken right||
1033|029|H|before bedtime.||
1033|030|H|   Shake the bottle well for 5 to10 seconds before each dose.||
1033|031|H|Carefully measure the dose using a special measuring||
1033|032|H|device/spoon. Do not use a household spoon because you may not||
1033|033|H|get the correct dose.||
1033|034|H|   The dosage and length of treatment are based on your medical||
1033|035|H|condition and response to treatment. Children's dosage may also||
1033|036|H|be based on weight. Follow your doctor's instructions carefully.||
1033|037|H|   If needed, antacids may be taken along with this medication.||
1033|038|H|   Use this medication regularly to get the most benefit from it.||
1033|039|H|To help you remember, take it at the same time(s) each day. Do||
1033|040|H|not increase your dose or use this drug more often or for longer||
1033|041|H|than prescribed. Your condition will not improve any faster, and||
1033|042|H|your risk of side effects will increase. Continue to take this||
1033|043|H|medication for the prescribed length of treatment even if you are||
1033|044|H|feeling better.||
1033|045|H|   Tell your doctor if your condition does not get better or if||
1033|046|H|it gets worse.||
1033|047|B|||
1033|048|S|SIDE EFFECTS:  Headache, constipation, or diarrhea may occur. If||
1033|049|S|any of these effects last or get worse, tell your doctor or||
1033|050|S|pharmacist promptly.||
1033|051|S|   Remember that this medication has been prescribed because your||
1033|052|S|doctor has judged that the benefit to you is greater than the||
1033|053|S|risk of side effects. Many people using this medication do not||
1033|054|S|have serious side effects.||
1033|055|S|   Tell your doctor right away if you have any serious side||
1033|056|S|effects, including: easy bleeding/bruising, signs of infection||
1033|057|S|(such as sore throat that doesn't go away, fever, chills),||
1033|058|S|mental/mood changes (such as agitation, confusion, depression,||
1033|059|S|hallucinations).||
1033|060|S|   Get medical help right away if you have any very serious side||
1033|061|S|effects, including: fast/slow/irregular heartbeat, severe||
1033|062|S|dizziness, fainting, seizure.||
1033|063|S|   A very serious allergic reaction to this drug is rare.||
1033|064|S|However, get medical help right away if you notice any symptoms||
1033|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1033|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1033|067|S|breathing.||
1033|068|S|   This is not a complete list of possible side effects. If you||
1033|069|S|notice other effects not listed above, contact your doctor or||
1033|070|S|pharmacist.||
1033|071|S|   In the US -||
1033|072|S|   Call your doctor for medical advice about side effects. You||
1033|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1033|074|S|www.fda.gov/medwatch.||
1033|075|S|   In Canada - Call your doctor for medical advice about side||
1033|076|S|effects. You may report side effects to Health Canada at||
1033|077|S|1-866-234-2345.||
1033|078|B|||
1033|079|P|PRECAUTIONS:  Before taking famotidine, tell your doctor or||
1033|080|P|pharmacist if you are allergic to it; or to other H2 blockers||
1033|081|P|(cimetidine, ranitidine, nizatidine); or if you have any other||
1033|082|P|allergies. This product may contain inactive ingredients, which||
1033|083|P|can cause allergic reactions or other problems. Talk to your||
1033|084|P|pharmacist for more details.||
1033|085|P|   Before using this medication, tell your doctor or pharmacist||
1033|086|P|your medical history, especially of: immune system problems,||
1033|087|P|kidney problems, liver problems, lung diseases (such as asthma,||
1033|088|P|chronic obstructive pulmonary disease-COPD), other stomach||
1033|089|P|problems (such as tumors).||
1033|090|P|   Some symptoms may actually be signs of a more serious||
1033|091|P|condition. Get medical help right away if you have: heartburn||
1033|092|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
1033|093|P|pain (especially with shortness of breath, unusual sweating),||
1033|094|P|unexplained weight loss.||
1033|095|P|   Before having surgery, tell your doctor or dentist about all||
1033|096|P|the products you use (including prescription drugs,||
1033|097|P|nonprescription drugs, and herbal products).||
1033|098|P|   Older adults may be more sensitive to the side effects of this||
1033|099|P|drug, especially mental/mood changes (such as confusion),||
1033|100|P|seizure, or unusual tiredness.||
1033|101|P|   During pregnancy, this medication should be used only when||
1033|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
1033|103|P|   This medication passes into breast milk. Consult your doctor||
1033|104|P|before breastfeeding.||
1033|105|B|||
1033|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1033|107|I|medications work or increase your risk for serious side effects.||
1033|108|I|This document does not contain all possible drug interactions.||
1033|109|I|Keep a list of all the products you use (including||
1033|110|I|prescription/nonprescription drugs and herbal products) and share||
1033|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
1033|112|I|the dosage of any medicines without your doctor's approval.||
1033|113|I|   A product that may interact with this drug is: fezolinetant.||
1033|114|I|   Some products need stomach acid so that the body can absorb||
1033|115|I|them properly. Famotidine decreases stomach acid, so it may||
1033|116|I|change how well these products work. Some affected products||
1033|117|I|include atazanavir, dasatinib, certain azole antifungals (such as||
1033|118|I|itraconazole, ketoconazole), levoketoconazole, pazopanib,||
1033|119|I|sparsentan, among others.||
1033|120|I|   Do not take this medication with other products that contain||
1033|121|I|famotidine or other H2 blockers (cimetidine, nizatidine,||
1033|122|I|ranitidine).||
1033|123|B|||
1033|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1033|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1033|126|O|poison control center right away. US residents can call||
1033|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1033|128|B|||
1033|129|N|NOTES:  Do not share this medication with others.||
1033|130|N|   Lifestyle changes such as stress reduction programs, stopping||
1033|131|N|smoking, limiting alcohol, and diet changes (such as avoiding||
1033|132|N|caffeine and certain spices) may help this medication work||
1033|133|N|better. Talk to your doctor or pharmacist about lifestyle changes||
1033|134|N|that might benefit you.||
1033|135|N|   Lab and/or medical tests (such as endoscopy, kidney function)||
1033|136|N|may be done while you are taking this medication. Keep all||
1033|137|N|medical and lab appointments. Consult your doctor for more||
1033|138|N|details.||
1033|139|B|||
1033|140|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1033|141|D|remember. If it is near the time of the next dose, skip the||
1033|142|D|missed dose. Take your next dose at the regular time. Do not||
1033|143|D|double the dose to catch up.||
1033|144|B|||
1033|145|R|STORAGE:  Store at room temperature away from light. Do not||
1033|146|R|freeze. Discard any unused portion after 30 days. Keep all||
1033|147|R|medications away from children and pets.||
1033|148|R|   Do not flush medications down the toilet or pour them into a||
1033|149|R|drain unless instructed to do so. Properly discard this product||
1033|150|R|when it is expired or no longer needed. Consult your pharmacist||
1033|151|R|or local waste disposal company.||
1033|152|B|||
1033|153|A|Information last revised October 2024.||
1033|154|A|Copyright(c) 2025 First Databank, Inc.||
1033|155|B|||
1034|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1034|002|Z|does NOT have all possible information about this product. This||
1034|003|Z|information does not assure that this product is safe, effective,||
1034|004|Z|or appropriate for you. This information is not individual||
1034|005|Z|medical advice and does not substitute for the advice of your||
1034|006|Z|health care professional. Always ask your health care||
1034|007|Z|professional for complete information about this product and your||
1034|008|Z|specific health needs.||
1034|009|B|||
1034|010|T|HALOPERIDOL DECANOATE - INTRAMUSCULAR INJECTION||
1034|011|F|(hal-oh-PAIR-ih-doll deck-ah-NO-ate)||
1034|012|B|||
1034|013|C|COMMON BRAND NAME(S): Haldol||
1034|014|B|||
1034|015|W|WARNING:  There may be a slightly increased risk of serious,||
1034|016|W|possibly fatal side effects (such as heart failure,||
1034|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1034|018|W|by older adults with dementia. This medication is not approved||
1034|019|W|for the treatment of dementia-related behavior problems. Discuss||
1034|020|W|the risks and benefits of this medication, as well as other||
1034|021|W|effective and possibly safer treatments for dementia-related||
1034|022|W|behavior problems, with the doctor.||
1034|023|B|||
1034|024|U|USES:  This medication is used to treat a certain mental/mood||
1034|025|U|disorder (schizophrenia). Haloperidol decanoate is a long-acting||
1034|026|U|form of haloperidol. It may be used by people who have trouble||
1034|027|U|remembering to take medication every day. Haloperidol belongs to||
1034|028|U|a class of drugs known as antipsychotics. It works by helping to||
1034|029|U|restore the balance of certain natural substances in the brain.||
1034|030|B|||
1034|031|V|OTHER USES:  This section contains uses of this drug that are not||
1034|032|V|listed in the approved professional labeling for the drug but||
1034|033|V|that may be prescribed by your health care professional. Use this||
1034|034|V|drug for a condition that is listed in this section only if it||
1034|035|V|has been so prescribed by your health care professional.||
1034|036|V|   This drug may also be used for severe behavior problems in||
1034|037|V|hyperactive children when other treatments or medications have||
1034|038|V|not worked.||
1034|039|B|||
1034|040|H|HOW TO USE:  This medication is the long-acting form of||
1034|041|H|haloperidol. It is usually used in people who have taken the form||
1034|042|H|of haloperidol that is taken by mouth. It is injected deep into a||
1034|043|H|muscle (usually the buttocks) by a healthcare professional. Your||
1034|044|H|first dose may be divided and given as separate injections, 3 to||
1034|045|H|7 days apart. After your doctor has found the best dose for you,||
1034|046|H|this medication is usually given once every 3 to 4 weeks. The||
1034|047|H|dosage is based on your condition and response to treatment.||
1034|048|H|   This medication takes a while to start working, so you will||
1034|049|H|need to continue to take your other medication by mouth until||
1034|050|H|your doctor tells you to stop.||
1034|051|H|   This medication must be used as prescribed. Do not suddenly||
1034|052|H|stop using this drug without consulting your doctor. Some||
1034|053|H|conditions may worsen if the medication is suddenly stopped.||
1034|054|H|   Tell your doctor if your symptoms do not get better or if they||
1034|055|H|get worse.||
1034|056|B|||
1034|057|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, difficulty||
1034|058|S|urinating, trouble sleeping, headache, anxiety, or pain at the||
1034|059|S|injection site may occur. If any of these effects last or get||
1034|060|S|worse, tell your doctor or pharmacist promptly.||
1034|061|S|   Dizziness and lightheadedness can increase the risk of||
1034|062|S|falling. Get up slowly when rising from a sitting or lying||
1034|063|S|position.||
1034|064|S|   Tell your doctor right away if any of these side effects||
1034|065|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
1034|066|S|mask-like expression of the face, drooling/trouble swallowing, or||
1034|067|S|shuffling walk. Your doctor may prescribe another medication to||
1034|068|S|decrease these side effects.||
1034|069|S|   Remember that this medication has been prescribed because your||
1034|070|S|doctor has judged that the benefit to you is greater than the||
1034|071|S|risk of side effects. Many people using this medication do not||
1034|072|S|have serious side effects.||
1034|073|S|   This medication may rarely cause a condition known as tardive||
1034|074|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1034|075|S|your doctor right away if you develop any facial/muscle twitching||
1034|076|S|such as tongue thrusting, chewing movements, puffing or puckering||
1034|077|S|of your mouth, or uncontrollable shaking.||
1034|078|S|   Tell your doctor right away if you have any serious side||
1034|079|S|effects, including: nausea/vomiting that doesn't stop,||
1034|080|S|stomach/abdominal pain, yellowing of eyes/skin, seizures, signs||
1034|081|S|of infection (such as sore throat that doesn't go away, fever,||
1034|082|S|chills).||
1034|083|S|   Get medical help right away if you have any very serious side||
1034|084|S|effects, including: slow heartbeat, severe dizziness, chest pain,||
1034|085|S|fainting.||
1034|086|S|   This medication may rarely cause a very serious condition||
1034|087|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1034|088|S|right away if you have any of the following symptoms: fever,||
1034|089|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1034|090|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1034|091|S|signs of kidney problems (such as change in the amount of urine).||
1034|092|S|   In rare cases, haloperidol may increase your level of a||
1034|093|S|certain chemical made by the body (prolactin). For females, this||
1034|094|S|increase in prolactin may result in unwanted breast milk,||
1034|095|S|missed/stopped periods, or difficulty becoming pregnant. For||
1034|096|S|males, it may result in decreased sexual ability, inability to||
1034|097|S|produce sperm, or enlarged breasts. If you develop any of these||
1034|098|S|symptoms, tell your doctor right away.||
1034|099|S|   Rarely, males may have a painful or prolonged erection lasting||
1034|100|S|4 or more hours. If this occurs, stop using this drug and get||
1034|101|S|medical help right away, or permanent problems could occur.||
1034|102|S|   A very serious allergic reaction to this drug is rare.||
1034|103|S|However, get medical help right away if you notice any symptoms||
1034|104|S|of a serious allergic reaction, including: rash, itching/swelling||
1034|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1034|106|S|breathing.||
1034|107|S|   This is not a complete list of possible side effects. If you||
1034|108|S|notice other effects not listed above, contact your doctor or||
1034|109|S|pharmacist.||
1034|110|S|   In the US -||
1034|111|S|   Call your doctor for medical advice about side effects. You||
1034|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1034|113|S|www.fda.gov/medwatch.||
1034|114|S|   In Canada - Call your doctor for medical advice about side||
1034|115|S|effects. You may report side effects to Health Canada at||
1034|116|S|1-866-234-2345.||
1034|117|B|||
1034|118|P|PRECAUTIONS:  Before using haloperidol, tell your doctor or||
1034|119|P|pharmacist if you are allergic to it; or if you have any other||
1034|120|P|allergies. This product may contain inactive ingredients (such as||
1034|121|P|sesame oil), which can cause allergic reactions or other||
1034|122|P|problems. Talk to your pharmacist for more details.||
1034|123|P|   Before using this medication, tell your doctor or pharmacist||
1034|124|P|your medical history, especially of: a certain severe nervous||
1034|125|P|system problem (severe CNS depression), Parkinson's disease,||
1034|126|P|bipolar disorder, difficulty urinating (such as due to prostate||
1034|127|P|problems), glaucoma, heart problems (such as angina), overactive||
1034|128|P|thyroid (hyperthyroidism), seizures, low white blood cell count.||
1034|129|P|   Haloperidol decanoate may cause a condition that affects the||
1034|130|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
1034|131|P|serious (rarely fatal) fast/irregular heartbeat and other||
1034|132|P|symptoms (such as severe dizziness, fainting) that need medical||
1034|133|P|attention right away.||
1034|134|P|   The risk of QT prolongation may be increased if you have||
1034|135|P|certain medical conditions or are taking other drugs that may||
1034|136|P|cause QT prolongation. Before using haloperidol decanoate, tell||
1034|137|P|your doctor or pharmacist of all the drugs you take and if you||
1034|138|P|have any of the following conditions: certain heart problems||
1034|139|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
1034|140|P|family history of certain heart problems (QT prolongation in the||
1034|141|P|EKG, sudden cardiac death).||
1034|142|P|   Low levels of potassium or magnesium in the blood may also||
1034|143|P|increase your risk of QT prolongation. This risk may increase if||
1034|144|P|you use certain drugs (such as diuretics/"water pills") or if you||
1034|145|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1034|146|P|Talk to your doctor about using haloperidol decanoate safely.||
1034|147|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1034|148|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1034|149|P|machinery, or do anything that needs alertness until you can do||
1034|150|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1034|151|P|are using marijuana (cannabis).||
1034|152|P|   Before having surgery, tell your doctor or dentist about all||
1034|153|P|the products you use (including prescription drugs,||
1034|154|P|nonprescription drugs, and herbal products).||
1034|155|P|   This medication may make you sweat less, making you more||
1034|156|P|likely to get heat stroke. Avoid doing things that may cause you||
1034|157|P|to overheat, such as hard work or exercise in hot weather, or||
1034|158|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1034|159|P|and dress lightly. If you overheat, quickly look for a place to||
1034|160|P|cool down and rest. Get medical help right away if you have a||
1034|161|P|fever that does not go away, mental/mood changes, headache, or||
1034|162|P|dizziness.||
1034|163|P|   Children may be more sensitive to the side effects of this||
1034|164|P|drug, especially uncontrolled movements.||
1034|165|P|   Older adults may be more sensitive to the side effects of this||
1034|166|P|drug, especially drowsiness, dizziness, lightheadedness,||
1034|167|P|difficulty urinating, and heart effects such as QT prolongation||
1034|168|P|(see above). Drowsiness, dizziness, and lightheadedness can||
1034|169|P|increase the risk of falling.||
1034|170|P|   During pregnancy, this medication should be used only when||
1034|171|P|clearly needed. Babies born to mothers who have used this drug||
1034|172|P|during the last 3 months of pregnancy may rarely develop symptoms||
1034|173|P|including muscle stiffness or shakiness, drowsiness,||
1034|174|P|feeding/breathing difficulties, or constant crying. If you notice||
1034|175|P|any of these symptoms in your newborn especially during their||
1034|176|P|first month, tell the doctor right away.||
1034|177|P|   Since untreated mental/mood problems (such as schizophrenia)||
1034|178|P|can be a serious condition, do not stop taking this medication||
1034|179|P|unless directed by your doctor. If you are planning pregnancy,||
1034|180|P|become pregnant, or think you may be pregnant, immediately||
1034|181|P|discuss with your doctor the benefits and risks of using this||
1034|182|P|medication during pregnancy.||
1034|183|P|   This drug passes into breast milk and could have undesirable||
1034|184|P|effects on a nursing infant. Consult your doctor before||
1034|185|P|breastfeeding.||
1034|186|B|||
1034|187|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1034|188|I|medications work or increase your risk for serious side effects.||
1034|189|I|This document does not contain all possible drug interactions.||
1034|190|I|Keep a list of all the products you use (including||
1034|191|I|prescription/nonprescription drugs and herbal products) and share||
1034|192|I|it with your doctor and pharmacist. Do not start, stop, or change||
1034|193|I|the dosage of any medicines without your doctor's approval.||
1034|194|I|   Some products that may interact with this drug include:||
1034|195|I|cabergoline, ketoconazole, lithium, methyldopa, paroxetine,||
1034|196|I|pergolide.||
1034|197|I|   Many drugs besides haloperidol decanoate may affect the heart||
1034|198|I|rhythm (QT prolongation), including amiodarone, dofetilide,||
1034|199|I|pimozide, quinidine, sotalol, procainamide, and macrolide||
1034|200|I|antibiotics (such as erythromycin), among others. Before using||
1034|201|I|haloperidol, report all medications you are currently using to||
1034|202|I|your doctor or pharmacist.||
1034|203|I|   Tell your doctor or pharmacist if you are taking other||
1034|204|I|products that cause drowsiness such as opioid pain or cough||
1034|205|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1034|206|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1034|207|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1034|208|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1034|209|I|diphenhydramine).||
1034|210|I|   Check the labels on all your medicines (such as allergy or||
1034|211|I|cough-and-cold products) because they may contain ingredients||
1034|212|I|that cause drowsiness. Ask your pharmacist about using those||
1034|213|I|products safely.||
1034|214|B|||
1034|215|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1034|216|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1034|217|O|poison control center right away. US residents can call||
1034|218|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1034|219|B|||
1034|220|N|NOTES:  Not applicable.||
1034|221|B|||
1034|222|D|MISSED DOSE:  If you miss an appointment, call your doctor as||
1034|223|D|soon as possible to set up an appointment. It is important that||
1034|224|D|you stay on schedule with this medication.||
1034|225|B|||
1034|226|R|STORAGE:  Not applicable. This medication is given in a doctor's||
1034|227|R|office and will not be stored at home.||
1034|228|B|||
1034|229|A|Information last revised April 2025.||
1034|230|A|Copyright(c) 2025 First Databank, Inc.||
1034|231|B|||
1035|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1035|002|Z|does NOT have all possible information about this product. This||
1035|003|Z|information does not assure that this product is safe, effective,||
1035|004|Z|or appropriate for you. This information is not individual||
1035|005|Z|medical advice and does not substitute for the advice of your||
1035|006|Z|health care professional. Always ask your health care||
1035|007|Z|professional for complete information about this product and your||
1035|008|Z|specific health needs.||
1035|009|B|||
1035|010|T|VITAMIN E PEG - ORAL||
1035|011|B|||
1035|012|C|COMMON BRAND NAME(S): Liqui-E||
1035|013|B|||
1035|014|U|USES:  This product is a man-made form of vitamin E, a fatty||
1035|015|U|substance that the body needs. Natural vitamin E is found in||
1035|016|U|high-fat foods such as nuts and oils. This product provides||
1035|017|U|vitamin E to people who cannot absorb fats due to disease (such||
1035|018|U|as cholestatic liver disease, short bowel syndrome). A low level||
1035|019|U|of vitamin E in the body is rare. Most people who eat a normal||
1035|020|U|diet do not need extra vitamin E.||
1035|021|U|   Too little vitamin E can cause nerve problems (numbness,||
1035|022|U|tingling, loss of balance). Vitamin E is important in protecting||
1035|023|U|your body's cells from damage. It is known as an antioxidant.||
1035|024|B|||
1035|025|H|HOW TO USE:  Take this product by mouth, usually once daily or as||
1035|026|H|directed by your doctor. Follow all directions on the product||
1035|027|H|package. If you have any questions, ask your doctor or||
1035|028|H|pharmacist.||
1035|029|H|   Shake the container well before measuring each dose. Carefully||
1035|030|H|measure the dose using a special measuring device/spoon. Do not||
1035|031|H|use a household spoon because you may not get the correct dose.||
1035|032|H|The dosage is based on your medical condition and response to||
1035|033|H|treatment. Do not increase your dose or take it more often than||
1035|034|H|recommended. Taking too much vitamin E may increase your risk of||
1035|035|H|side effects.||
1035|036|H|   High doses of vitamin E (more than 400 units a day) may||
1035|037|H|increase the chance of rare but very serious side effects. There||
1035|038|H|is no proof that high doses of vitamin E help to prevent or treat||
1035|039|H|heart disease. There is very little evidence that it helps||
1035|040|H|prevent or treat Alzheimer's disease. In some people, high doses||
1035|041|H|may even be harmful. Before taking extra vitamin E, discuss the||
1035|042|H|risks and benefits with your doctor or pharmacist.||
1035|043|H|   If your doctor prescribes this product for low levels||
1035|044|H|(deficiency) of vitamin E, use it regularly to get the most||
1035|045|H|benefit from it. To help you remember, take it at the same time||
1035|046|H|each day. You should see improvement of symptoms such as||
1035|047|H|numbness/tingling of the hands/feet and weakness. Tell your||
1035|048|H|doctor if your condition lasts or gets worse. If you think you||
1035|049|H|may have a serious medical problem, get medical help right away.||
1035|050|B|||
1035|051|S|SIDE EFFECTS:  Vitamin E does not usually cause side effects when||
1035|052|S|used in recommended doses. However, if vitamin E is taken in high||
1035|053|S|doses (more than 400 units a day) or for a long time, side||
1035|054|S|effects such as nausea, diarrhea, stomach cramps, tiredness,||
1035|055|S|blurred vision, and headache may rarely occur. If any of these||
1035|056|S|effects last or get worse, tell your doctor or pharmacist||
1035|057|S|promptly.||
1035|058|S|   If your doctor has directed you to use this medication,||
1035|059|S|remember that your doctor has judged that the benefit to you is||
1035|060|S|greater than the risk of side effects. Many people using this||
1035|061|S|medication do not have serious side effects.||
1035|062|S|   Tell your doctor right away if you have any serious side||
1035|063|S|effects, including: easy bleeding/bruising.||
1035|064|S|   A very serious allergic reaction to this drug is rare.||
1035|065|S|However, get medical help right away if you notice any symptoms||
1035|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1035|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1035|068|S|breathing.||
1035|069|S|   This is not a complete list of possible side effects. If you||
1035|070|S|notice other effects not listed above, contact your doctor or||
1035|071|S|pharmacist.||
1035|072|S|   In the US -||
1035|073|S|   Call your doctor for medical advice about side effects. You||
1035|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1035|075|S|www.fda.gov/medwatch.||
1035|076|S|   In Canada - Call your doctor for medical advice about side||
1035|077|S|effects. You may report side effects to Health Canada at||
1035|078|S|1-866-234-2345.||
1035|079|B|||
1035|080|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1035|081|P|pharmacist if you are allergic to vitamin E; or to polyethylene||
1035|082|P|glycol or other ingredients listed on the package label; or if||
1035|083|P|you have any other allergies. This product may contain inactive||
1035|084|P|ingredients, which can cause allergic reactions or other||
1035|085|P|problems. Talk to your pharmacist for more details.||
1035|086|P|   If you have any of the following health problems, consult your||
1035|087|P|doctor or pharmacist before using this product: blood||
1035|088|P|clotting/bleeding problems (such as stomach ulcers, hemophilia,||
1035|089|P|low platelets), certain type of stroke (hemorrhagic), liver||
1035|090|P|disease.||
1035|091|P|   Before having surgery, tell your doctor or dentist about all||
1035|092|P|the products you use (including prescription drugs,||
1035|093|P|nonprescription drugs, and herbal products). Your doctor may||
1035|094|P|direct you to stop taking this product 1 month before surgery to||
1035|095|P|prevent bleeding problems.||
1035|096|P|   During pregnancy, this product should be used only when||
1035|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
1035|098|P|   It is unknown if this product passes into breast milk. Consult||
1035|099|P|your doctor before breastfeeding.||
1035|100|B|||
1035|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1035|102|I|medications work or increase your risk for serious side effects.||
1035|103|I|This document does not contain all possible drug interactions.||
1035|104|I|Keep a list of all the products you use (including||
1035|105|I|prescription/nonprescription drugs and herbal products) and share||
1035|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
1035|107|I|the dosage of any medicines without your doctor's approval.||
1035|108|I|   Some drugs that may interact with this product are:||
1035|109|I|anti-platelet drugs (such as aspirin, clopidogrel), "blood||
1035|110|I|thinners" (such as warfarin), herbal products that can increase||
1035|111|I|your risk of bleeding (such as garlic, gingko), fat-soluble||
1035|112|I|supplements (such as vitamins A/D/E/K, coenzyme Q), iron||
1035|113|I|supplements, selenium.||
1035|114|I|   If your doctor has directed you to take low doses of aspirin||
1035|115|I|(usually 81-162 milligrams a day) or other treatment to prevent||
1035|116|I|heart attack or stroke, you should continue to take them. Consult||
1035|117|I|your doctor or pharmacist for more details.||
1035|118|I|   Check the labels on all your prescription and||
1035|119|I|nonprescription/herbal products because they may contain vitamin||
1035|120|I|E. Ask your doctor or pharmacist about using those products||
1035|121|I|safely.||
1035|122|B|||
1035|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1035|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1035|125|O|poison control center right away. US residents can call||
1035|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1035|127|B|||
1035|128|N|NOTES:  Keep all medical and lab appointments.||
1035|129|N|   Eat a well-balanced diet. Foods high in vitamin E include||
1035|130|N|vegetable oils, wheat germ oil, whole grain cereals, meat,||
1035|131|N|poultry, and green leafy vegetables.||
1035|132|B|||
1035|133|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1035|134|D|remember. If it is near the time of the next dose, skip the||
1035|135|D|missed dose. Take your next dose at the regular time. Do not||
1035|136|D|double the dose to catch up.||
1035|137|B|||
1035|138|R|STORAGE:  Store at room temperature away from heat, light, and||
1035|139|R|moisture. Some brands should be stored in the refrigerator after||
1035|140|R|opening. Refer to storage information printed on the package. Do||
1035|141|R|not store in the bathroom. Keep all medications away from||
1035|142|R|children and pets.||
1035|143|R|   Do not flush medications down the toilet or pour them into a||
1035|144|R|drain unless instructed to do so. Properly discard this product||
1035|145|R|when it is expired or no longer needed. Consult your pharmacist||
1035|146|R|or local waste disposal company.||
1035|147|B|||
1035|148|A|Information last revised November 2025.||
1035|149|A|Copyright(c) 2025 First Databank, Inc.||
1035|150|B|||
1036|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1036|002|Z|does NOT have all possible information about this product. This||
1036|003|Z|information does not assure that this product is safe, effective,||
1036|004|Z|or appropriate for you. This information is not individual||
1036|005|Z|medical advice and does not substitute for the advice of your||
1036|006|Z|health care professional. Always ask your health care||
1036|007|Z|professional for complete information about this product and your||
1036|008|Z|specific health needs.||
1036|009|B|||
1036|010|T|RALTEGRAVIR - ORAL||
1036|011|F|(ral-TEG-ra-vir)||
1036|012|B|||
1036|013|C|COMMON BRAND NAME(S): Isentress||
1036|014|B|||
1036|015|U|USES:  Raltegravir is used with other HIV medications to help||
1036|016|U|control HIV infection. It helps to decrease the amount of HIV in||
1036|017|U|your body so your immune system can work better. This lowers your||
1036|018|U|chance of getting HIV complications (such as new infections,||
1036|019|U|cancer) and improves your quality of life. Raltegravir is known||
1036|020|U|as an integrase inhibitor. It blocks the virus from growing and||
1036|021|U|infecting more cells.||
1036|022|U|   Raltegravir is not a cure for HIV infection. To decrease your||
1036|023|U|risk of spreading HIV disease to others, continue to take all HIV||
1036|024|U|medications exactly as prescribed by your doctor. Use an||
1036|025|U|effective barrier method (latex or polyurethane condoms/dental||
1036|026|U|dams) during sexual activity as directed by your doctor. Do not||
1036|027|U|share personal items (such as needles/syringes, toothbrushes, and||
1036|028|U|razors) that may have contacted blood or other body fluids.||
1036|029|U|Consult your doctor or pharmacist for more details.||
1036|030|B|||
1036|031|V|OTHER USES:  This section contains uses of this drug that are not||
1036|032|V|listed in the approved professional labeling for the drug but||
1036|033|V|that may be prescribed by your health care professional. Use this||
1036|034|V|drug for a condition that is listed in this section only if it||
1036|035|V|has been so prescribed by your health care professional.||
1036|036|V|   This product may also be used to lessen the risk of HIV||
1036|037|V|infection after contact with the virus (for example, due to a||
1036|038|V|needle stick). Ask your doctor for more details.||
1036|039|B|||
1036|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1036|041|H|from your pharmacist before you start taking raltegravir and each||
1036|042|H|time you get a refill. If you have any questions, ask your doctor||
1036|043|H|or pharmacist.||
1036|044|H|   Take this medication by mouth with or without food as directed||
1036|045|H|by your doctor, usually once or twice daily.||
1036|046|H|   The dosage is based on your medical condition, response to||
1036|047|H|treatment, and other medications you may be taking. Be sure to||
1036|048|H|tell your doctor and pharmacist about all the products you use||
1036|049|H|(including prescription drugs, nonprescription drugs, and herbal||
1036|050|H|products).||
1036|051|H|   The manufacturer directs to swallow this medication whole.||
1036|052|H|However, many similar drugs (immediate-release tablets) can be||
1036|053|H|split/crushed. Follow your doctor's directions on how to take||
1036|054|H|this medication.||
1036|055|H|   Avoid using antacids that contain aluminum or magnesium while||
1036|056|H|taking this medication. These antacids can make raltegravir work||
1036|057|H|less well.||
1036|058|H|   It is very important to keep taking this medication (and other||
1036|059|H|HIV medications) exactly as prescribed by your doctor. Do not||
1036|060|H|skip any doses.||
1036|061|H|   Do not increase your dose or use this drug more often or for||
1036|062|H|longer than prescribed. Your condition will not improve any||
1036|063|H|faster, and your risk of side effects will increase.||
1036|064|H|   Do not take less of this drug than prescribed or stop taking||
1036|065|H|it (or other HIV medicines) even for a short time unless directed||
1036|066|H|to do so by your doctor. Doing so may cause the amount of virus||
1036|067|H|to increase and/or make the infection more difficult to treat||
1036|068|H|(resistant).||
1036|069|H|   For the best effect, take this medication at evenly spaced||
1036|070|H|times. To help you remember, take this medication at the same||
1036|071|H|time(s) every day.||
1036|072|H|   Do not switch between the film-coated tablet, the chewable||
1036|073|H|tablet, or the powder packet for oral suspension forms of||
1036|074|H|raltegravir without asking your doctor or pharmacist first.||
1036|075|B|||
1036|076|S|SIDE EFFECTS:  Headache, nausea, and trouble sleeping may occur.||
1036|077|S|If any of these effects last or get worse, tell your doctor or||
1036|078|S|pharmacist promptly.||
1036|079|S|   Remember that this medication has been prescribed because your||
1036|080|S|doctor has judged that the benefit to you is greater than the||
1036|081|S|risk of side effects. Many people using this medication do not||
1036|082|S|have serious side effects.||
1036|083|S|   As your immune system gets stronger, it can begin to fight off||
1036|084|S|infections you already had, possibly causing disease symptoms to||
1036|085|S|come back. You could also have symptoms if your immune system||
1036|086|S|becomes overactive. This reaction may happen at any time (soon||
1036|087|S|after starting HIV treatment or many months later). Tell your||
1036|088|S|doctor right away if you have any serious symptoms, including:||
1036|089|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1036|090|S|that doesn't go away, headaches that are severe or don't go away,||
1036|091|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1036|092|S|changes, signs of infection (such as sore throat that doesn't go||
1036|093|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1036|094|S|sores), signs of an overactive thyroid (such as irritability,||
1036|095|S|nervousness, heat intolerance, fast/pounding/irregular||
1036|096|S|heartbeat).||
1036|097|S|   Tell your doctor right away if you have any serious side||
1036|098|S|effects, including: nausea/vomiting that doesn't stop, signs of||
1036|099|S|kidney problems (such as change in the amount of urine), loss of||
1036|100|S|appetite, severe stomach/abdominal pain, dark urine, yellowing||
1036|101|S|eyes/skin.||
1036|102|S|   Changes in body fat may occur while you are taking this||
1036|103|S|medication (such as increased fat in the upper back and stomach||
1036|104|S|areas, decreased fat in the arms and legs). The cause and||
1036|105|S|long-term effects of these changes are unknown. Discuss the risks||
1036|106|S|and benefits of treatment with your doctor, as well as the||
1036|107|S|possible use of exercise to reduce this side effect.||
1036|108|S|   A very serious allergic reaction to this drug is rare.||
1036|109|S|However, get medical help right away if you notice any symptoms||
1036|110|S|of a serious allergic reaction, including: rash (especially if||
1036|111|S|you also have fever, blisters, mouth sores, eye redness/swelling,||
1036|112|S|muscle/joint pain), itching/swelling (especially of the||
1036|113|S|face/tongue/throat), severe dizziness, trouble breathing.||
1036|114|S|   This is not a complete list of possible side effects. If you||
1036|115|S|notice other effects not listed above, contact your doctor or||
1036|116|S|pharmacist.||
1036|117|S|   In the US -||
1036|118|S|   Call your doctor for medical advice about side effects. You||
1036|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1036|120|S|www.fda.gov/medwatch.||
1036|121|S|   In Canada - Call your doctor for medical advice about side||
1036|122|S|effects. You may report side effects to Health Canada at||
1036|123|S|1-866-234-2345.||
1036|124|B|||
1036|125|P|PRECAUTIONS:  Before taking raltegravir, tell your doctor or||
1036|126|P|pharmacist if you are allergic to it; or if you have any other||
1036|127|P|allergies. This product may contain inactive ingredients, which||
1036|128|P|can cause allergic reactions or other problems. Talk to your||
1036|129|P|pharmacist for more details.||
1036|130|P|   Before using this medication, tell your doctor or pharmacist||
1036|131|P|your medical history, especially of: liver disease (such as||
1036|132|P|hepatitis B, hepatitis C), muscle disorders (such as||
1036|133|P|rhabdomyolysis, myopathy), high blood levels of creatine kinase||
1036|134|P|(high CK test results).||
1036|135|P|   Before having surgery, tell your doctor or dentist about all||
1036|136|P|the products you use (including prescription drugs,||
1036|137|P|nonprescription drugs, and herbal products).||
1036|138|P|   During pregnancy, this medication should be used only when||
1036|139|P|clearly needed. Treatment can lower the risk of passing HIV||
1036|140|P|infection to your baby, and raltegravir may be part of that||
1036|141|P|treatment. Discuss the risks and benefits with your doctor.||
1036|142|P|   This medication passes into breast milk. Because breast milk||
1036|143|P|may transmit HIV, consult your doctor before breastfeeding.||
1036|144|B|||
1036|145|I|DRUG INTERACTIONS:  See also How to Use section.||
1036|146|I|   Drug interactions may change how your medications work or||
1036|147|I|increase your risk for serious side effects. This document does||
1036|148|I|not contain all possible drug interactions. Keep a list of all||
1036|149|I|the products you use (including prescription/nonprescription||
1036|150|I|drugs and herbal products) and share it with your doctor and||
1036|151|I|pharmacist. Do not start, stop, or change the dosage of any||
1036|152|I|medicines without your doctor's approval.||
1036|153|I|   A product that may interact with this drug is: orlistat.||
1036|154|B|||
1036|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1036|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1036|157|O|poison control center right away. US residents can call||
1036|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1036|159|B|||
1036|160|N|NOTES:  Do not share this medication with others.||
1036|161|N|   Lab and/or medical tests (such as viral load, T-cell counts)||
1036|162|N|should be done while you are taking this medication. Keep all||
1036|163|N|medical and lab appointments. Consult your doctor for more||
1036|164|N|details.||
1036|165|B|||
1036|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1036|167|D|remember. If it is near the time of the next dose, skip the||
1036|168|D|missed dose. Take your next dose at the regular time. Do not||
1036|169|D|double the dose to catch up.||
1036|170|B|||
1036|171|R|STORAGE:  Store in the original package at room temperature away||
1036|172|R|from light and moisture. Do not store in the bathroom. Keep the||
1036|173|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1036|174|R|when not in use. Keep all medications away from children and||
1036|175|R|pets.||
1036|176|R|   Do not flush medications down the toilet or pour them into a||
1036|177|R|drain unless instructed to do so. Properly discard this product||
1036|178|R|when it is expired or no longer needed. Consult your pharmacist||
1036|179|R|or local waste disposal company.||
1036|180|B|||
1036|181|A|Information last revised April 2025.||
1036|182|A|Copyright(c) 2025 First Databank, Inc.||
1036|183|B|||
1037|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1037|002|Z|does NOT have all possible information about this product. This||
1037|003|Z|information does not assure that this product is safe, effective,||
1037|004|Z|or appropriate for you. This information is not individual||
1037|005|Z|medical advice and does not substitute for the advice of your||
1037|006|Z|health care professional. Always ask your health care||
1037|007|Z|professional for complete information about this product and your||
1037|008|Z|specific health needs.||
1037|009|B|||
1037|010|T|FLUOCINOLONE OIL - OTIC||
1037|011|F|(FLOO-oh-SIN-oh-lone)||
1037|012|B|||
1037|013|C|COMMON BRAND NAME(S): Dermotic||
1037|014|B|||
1037|015|U|USES:  This medication is used to treat eczema of the outer ear||
1037|016|U|(also known as chronic itchy ear). The main symptom is itchiness,||
1037|017|U|but redness, flaking, or oozing may also occur. Fluocinolone||
1037|018|U|reduces these symptoms. This medication is a low- to||
1037|019|U|medium-strength corticosteroid.||
1037|020|B|||
1037|021|H|HOW TO USE:  To apply ear drops, wash your hands first. To avoid||
1037|022|H|contamination, do not touch the dropper tip or let it touch your||
1037|023|H|ear or any other surface. Lie on your side or tilt the affected||
1037|024|H|ear upward. Hold the dropper directly over the ear, and place the||
1037|025|H|prescribed number of drops into the ear canal as directed by your||
1037|026|H|doctor, usually twice a day. To help the drops roll into the ear||
1037|027|H|of an adult, hold the earlobe up and back. In children, hold the||
1037|028|H|earlobe down and back. Keep the head tilted for about 1 minute,||
1037|029|H|or insert a soft cotton plug if so directed. Remove the plug||
1037|030|H|after 1 minute. Repeat for the other ear if so directed. Do not||
1037|031|H|rinse the dropper. Replace the cap after use. Do not bandage,||
1037|032|H|cover, or wrap the area unless directed to do so by your doctor.||
1037|033|H|   Avoid getting this medication in the eyes, nose, or mouth. If||
1037|034|H|you get the medication in these areas, rinse with plenty of||
1037|035|H|water.||
1037|036|H|   Dosage is based on your medical condition and response to||
1037|037|H|treatment.||
1037|038|H|   Use this medication regularly to get the most benefit from it.||
1037|039|H|To help you remember, use it at the same times each day.||
1037|040|H|   Use this medication only for the condition for which it was||
1037|041|H|prescribed. Do not use it for longer than prescribed.||
1037|042|H|   Tell your doctor if your condition lasts or gets worse after 2||
1037|043|H|weeks.||
1037|044|B|||
1037|045|S|SIDE EFFECTS:  Stinging, burning, irritation, dryness, or redness||
1037|046|S|at the application site may occur. If any of these effects last||
1037|047|S|or get worse, tell your doctor or pharmacist promptly.||
1037|048|S|   Remember that this medication has been prescribed because your||
1037|049|S|doctor has judged that the benefit to you is greater than the||
1037|050|S|risk of side effects. Many people using this medication do not||
1037|051|S|have serious side effects.||
1037|052|S|   A very serious allergic reaction to this drug is rare.||
1037|053|S|However, get medical help right away if you notice any symptoms||
1037|054|S|of a serious allergic reaction, including: rash, itching/swelling||
1037|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1037|056|S|breathing.||
1037|057|S|   This is not a complete list of possible side effects. If you||
1037|058|S|notice other effects not listed above, contact your doctor or||
1037|059|S|pharmacist.||
1037|060|S|   In the US -||
1037|061|S|   Call your doctor for medical advice about side effects. You||
1037|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1037|063|S|www.fda.gov/medwatch.||
1037|064|S|   In Canada - Call your doctor for medical advice about side||
1037|065|S|effects. You may report side effects to Health Canada at||
1037|066|S|1-866-234-2345.||
1037|067|B|||
1037|068|P|PRECAUTIONS:  Before using fluocinolone, tell your doctor or||
1037|069|P|pharmacist if you are allergic to it; or to other corticosteroids||
1037|070|P|(such as hydrocortisone, prednisone); or if you have any other||
1037|071|P|allergies. This product may contain inactive ingredients (such as||
1037|072|P|peanut oil), which can cause allergic reactions or other||
1037|073|P|problems. Talk to your pharmacist for more details.||
1037|074|P|   Before using this medication, tell your doctor or pharmacist||
1037|075|P|your medical history.||
1037|076|P|   Do not use if there is an infection or sore in the area to be||
1037|077|P|treated. Skin infections can become worse when this medication is||
1037|078|P|used. Tell your doctor promptly if redness, swelling, or||
1037|079|P|irritation does not improve.||
1037|080|P|   During pregnancy, this product should be used only when||
1037|081|P|clearly needed. Discuss the risks and benefits with your doctor.||
1037|082|P|   It is unknown if this drug passes into breast milk when||
1037|083|P|applied to the skin. Similar medications pass into breast milk||
1037|084|P|when taken by mouth. Consult your doctor before breastfeeding.||
1037|085|B|||
1037|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1037|087|I|medications work or increase your risk for serious side effects.||
1037|088|I|This document does not contain all possible drug interactions.||
1037|089|I|Keep a list of all the products you use (including||
1037|090|I|prescription/nonprescription drugs and herbal products) and share||
1037|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
1037|092|I|the dosage of any medicines without your doctor's approval.||
1037|093|B|||
1037|094|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1037|095|O|has overdosed and has serious symptoms such as passing out or||
1037|096|O|trouble breathing, call 911. Otherwise, call a poison control||
1037|097|O|center right away. US residents can call 1-800-222-1222. Canada||
1037|098|O|residents can call 1-844-764-7669.||
1037|099|B|||
1037|100|N|NOTES:  Do not share this medication with others.||
1037|101|B|||
1037|102|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1037|103|D|If it is near the time of the next dose, skip the missed dose.||
1037|104|D|Use your next dose at the regular time. Do not double the dose to||
1037|105|D|catch up.||
1037|106|B|||
1037|107|R|STORAGE:  Different brands of this medication have different||
1037|108|R|storage needs. Check the product package for instructions on how||
1037|109|R|to store your brand, or ask your pharmacist. Keep all medications||
1037|110|R|away from children and pets.||
1037|111|R|   Do not flush medications down the toilet or pour them into a||
1037|112|R|drain unless instructed to do so. Properly discard this product||
1037|113|R|when it is expired or no longer needed. Consult your pharmacist||
1037|114|R|or local waste disposal company.||
1037|115|B|||
1037|116|A|Information last revised September 2024.||
1037|117|A|Copyright(c) 2025 First Databank, Inc.||
1037|118|B|||
1038|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1038|002|Z|does NOT have all possible information about this product. This||
1038|003|Z|information does not assure that this product is safe, effective,||
1038|004|Z|or appropriate for you. This information is not individual||
1038|005|Z|medical advice and does not substitute for the advice of your||
1038|006|Z|health care professional. Always ask your health care||
1038|007|Z|professional for complete information about this product and your||
1038|008|Z|specific health needs.||
1038|009|B|||
1038|010|T|VITAMIN A - ORAL||
1038|011|B|||
1038|012|C|COMMON BRAND NAME(S): Aquasol A||
1038|013|B|||
1038|014|U|USES:  Vitamin A is used to prevent or treat low levels of the||
1038|015|U|vitamin in people who do not get enough of it from their diets.||
1038|016|U|Most people who eat a normal diet do not need extra vitamin A.||
1038|017|U|However, some conditions (such as protein deficiency, diabetes,||
1038|018|U|hyperthyroidism, liver/pancreas problems) can cause low levels of||
1038|019|U|vitamin A. Vitamin A plays an important role in the body. It is||
1038|020|U|needed for growth and bone development and to maintain the health||
1038|021|U|of the skin and eyesight. Low levels of vitamin A may cause||
1038|022|U|vision problems (such as night blindness) and permanent eye||
1038|023|U|damage.||
1038|024|B|||
1038|025|H|HOW TO USE:  Take this vitamin by mouth with or without food,||
1038|026|H|usually once daily. Follow all directions on the product package,||
1038|027|H|or take as directed by your doctor. If you have any questions,||
1038|028|H|ask your doctor or pharmacist.||
1038|029|H|   If you are using the liquid form of this medication, shake the||
1038|030|H|bottle well before each dose. Carefully measure the dose using a||
1038|031|H|special measuring device/spoon. Do not use a household spoon||
1038|032|H|because you may not get the correct dose.||
1038|033|H|   Dosage is based on your age, medical condition, and response||
1038|034|H|to treatment.||
1038|035|H|   Use this vitamin regularly to get the most benefit from it. To||
1038|036|H|help you remember, take it at the same time each day. Do not||
1038|037|H|increase your dose or use this vitamin more often than||
1038|038|H|recommended. Your condition will not improve any faster, and your||
1038|039|H|risk of side effects will increase.||
1038|040|H|   Tell your doctor if your condition lasts or gets worse. If you||
1038|041|H|think you may have a serious medical problem, get medical help||
1038|042|H|right away.||
1038|043|B|||
1038|044|S|SIDE EFFECTS:  This vitamin usually has no side effects when used||
1038|045|S|in recommended doses. If you have any unusual effects, contact||
1038|046|S|your doctor or pharmacist promptly.||
1038|047|S|   A very serious allergic reaction to this vitamin is rare.||
1038|048|S|However, get medical help right away if you notice any symptoms||
1038|049|S|of a serious allergic reaction, including: rash, itching/swelling||
1038|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1038|051|S|breathing.||
1038|052|S|   This is not a complete list of possible side effects. If you||
1038|053|S|notice other effects not listed above, contact your doctor or||
1038|054|S|pharmacist.||
1038|055|S|   In the US -||
1038|056|S|   Call your doctor for medical advice about side effects. You||
1038|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1038|058|S|www.fda.gov/medwatch.||
1038|059|S|   In Canada - Call your doctor for medical advice about side||
1038|060|S|effects. You may report side effects to Health Canada at||
1038|061|S|1-866-234-2345.||
1038|062|B|||
1038|063|P|PRECAUTIONS:  Before taking vitamin A, tell your doctor or||
1038|064|P|pharmacist if you are allergic to it; or if you have any other||
1038|065|P|allergies. This product may contain inactive ingredients (such as||
1038|066|P|soy found in some brands),which can cause allergic reactions or||
1038|067|P|other problems. Talk to your pharmacist for more details.||
1038|068|P|   Before having surgery, tell your doctor or dentist about all||
1038|069|P|the products you use (including prescription drugs,||
1038|070|P|nonprescription drugs, and herbal products).||
1038|071|P|   During pregnancy, this vitamin has been found to be safe only||
1038|072|P|when used in recommended doses. It must not be used in doses that||
1038|073|P|are higher than recommended because doing so may harm an unborn||
1038|074|P|baby. Consult your doctor for more details.||
1038|075|P|   This vitamin passes into breast milk and is considered safe||
1038|076|P|during breastfeeding when used in recommended doses. Consult your||
1038|077|P|doctor for more information.||
1038|078|B|||
1038|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1038|080|I|medications work or increase your risk for serious side effects.||
1038|081|I|This document does not contain all possible drug interactions.||
1038|082|I|Keep a list of all the products you use (including||
1038|083|I|prescription/nonprescription drugs and herbal products) and share||
1038|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
1038|085|I|the dosage of any medicines without your doctor's approval.||
1038|086|I|   Some products that may interact with this vitamin are:||
1038|087|I|acitretin, alitretinoin, bexarotene, cholestyramine,||
1038|088|I|isotretinoin, tretinoin, other products that contain vitamin A||
1038|089|I|(such as multivitamins), warfarin.||
1038|090|I|   Avoid taking vitamin A at the same time as you take neomycin,||
1038|091|I|orlistat, and mineral oil. If you take any of these medications,||
1038|092|I|separate your doses from your dose of vitamin A by at least 2||
1038|093|I|hours.||
1038|094|B|||
1038|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1038|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1038|097|O|poison control center right away. US residents can call||
1038|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1038|099|O|Symptoms of overdose may include: severe headache, tiredness,||
1038|100|O|dizziness, mental/mood changes (such as irritability,||
1038|101|O|depression), vision changes (such as double vision, blurred||
1038|102|O|vision), dry/peeling skin, bone/joint pain, loss of appetite,||
1038|103|O|yellowing skin/eyes, dark urine, severe stomach/abdominal pain.||
1038|104|B|||
1038|105|N|NOTES:  This product is not a substitute for a proper diet. It is||
1038|106|N|best to get your vitamins from healthy foods. Vitamin A is||
1038|107|N|commonly found in fruits (such as apricots, oranges, peaches),||
1038|108|N|vegetables (such as carrots, sweet potatoes, spinach), dairy||
1038|109|N|products, and eggs, among others. Consult your doctor,||
1038|110|N|pharmacist, or nutritionist for more details.||
1038|111|B|||
1038|112|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1038|113|D|remember. If it is near the time of the next dose, skip the||
1038|114|D|missed dose. Take your next dose at the regular time. Do not||
1038|115|D|double the dose to catch up.||
1038|116|B|||
1038|117|R|STORAGE:  Different brands of this vitamin have different storage||
1038|118|R|needs. Check the product package for instructions on how to store||
1038|119|R|your brand, or ask your pharmacist. Do not store in the bathroom.||
1038|120|R|Keep all medications away from children and pets.||
1038|121|R|   Do not flush medications down the toilet or pour them into a||
1038|122|R|drain unless instructed to do so. Properly discard this product||
1038|123|R|when it is expired or no longer needed. Consult your pharmacist||
1038|124|R|or local waste disposal company.||
1038|125|B|||
1038|126|A|Information last revised May 2025.||
1038|127|A|Copyright(c) 2025 First Databank, Inc.||
1038|128|B|||
1039|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1039|002|Z|does NOT have all possible information about this product. This||
1039|003|Z|information does not assure that this product is safe, effective,||
1039|004|Z|or appropriate for you. This information is not individual||
1039|005|Z|medical advice and does not substitute for the advice of your||
1039|006|Z|health care professional. Always ask your health care||
1039|007|Z|professional for complete information about this product and your||
1039|008|Z|specific health needs.||
1039|009|B|||
1039|010|T|BEXAROTENE - ORAL||
1039|011|F|(bex-AR-oh-teen)||
1039|012|B|||
1039|013|C|COMMON BRAND NAME(S): Targretin||
1039|014|B|||
1039|015|W|WARNING:  This medication can cause severe birth defects if used||
1039|016|W|during pregnancy. Women who are pregnant must not use bexarotene.||
1039|017|W|If pregnancy occurs, notify your doctor right away. You should||
1039|018|W|have a pregnancy test and birth control counseling from your||
1039|019|W|doctor before you start treatment with bexarotene and every month||
1039|020|W|while you are taking the medication. Use 2 effective forms of||
1039|021|W|birth control together (or completely avoid sexual intercourse)||
1039|022|W|starting 1 month before treatment starts, during treatment, and||
1039|023|W|for 1 month after you stop. One of your forms of birth control||
1039|024|W|should be non-hormonal (for example, a barrier method such as||
1039|025|W|condoms/cervical cap/diaphragm, copper coil IUD, or spermicide).||
1039|026|W|   Males taking this medication should use a condom during sexual||
1039|027|W|activity with a woman who is pregnant or may become pregnant,||
1039|028|W|continuing until 1 month after their last dose.||
1039|029|B|||
1039|030|U|USES:  Bexarotene is used to treat skin problems from a certain||
1039|031|U|type of cancer (cutaneous T-cell lymphoma-CTCL). It belongs to a||
1039|032|U|class of drugs called retinoids (vitamin A derivatives).||
1039|033|U|Bexarotene works by slowing or stopping the growth of cells.||
1039|034|B|||
1039|035|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1039|036|H|from your pharmacist before you start using bexarotene and each||
1039|037|H|time you get a refill. If you have any questions, consult your||
1039|038|H|doctor or pharmacist.||
1039|039|H|   Take this medication by mouth with or immediately after a meal||
1039|040|H|as directed by your doctor, usually once daily. The dosage is||
1039|041|H|based on your body size, medical condition, and response to||
1039|042|H|treatment. Swallow the medication whole. Do not crush or chew the||
1039|043|H|medication. Do not use the capsule if it is broken or leaking. If||
1039|044|H|the contents of the capsule touch your skin, immediately wash the||
1039|045|H|area with soap and water and tell your doctor.||
1039|046|H|   Do not increase your dose or take this medication more often||
1039|047|H|than prescribed. Your condition will not improve any faster, and||
1039|048|H|the risk of serious side effects may be increased.||
1039|049|H|   It may take up to several months of continued use to see a||
1039|050|H|response to treatment. Your dosage may need to be adjusted by||
1039|051|H|your doctor during this time.||
1039|052|H|   Since this drug can be absorbed through the skin and lungs and||
1039|053|H|may harm an unborn baby, women who are pregnant or who may become||
1039|054|H|pregnant should not handle this medication or breathe the dust||
1039|055|H|from the capsules. Learn proper technique for safe handling and||
1039|056|H|disposal of this medicine and its container. Consult your||
1039|057|H|pharmacist.||
1039|058|B|||
1039|059|S|SIDE EFFECTS:  Headache, tiredness, nausea, vomiting, dry skin,||
1039|060|S|diarrhea, or trouble sleeping may occur. If any of these effects||
1039|061|S|last or get worse, notify your doctor.||
1039|062|S|   Remember that this medication has been prescribed because your||
1039|063|S|doctor has judged that the benefit to you is greater than the||
1039|064|S|risk of side effects. Many people using this medication do not||
1039|065|S|have serious side effects.||
1039|066|S|   This medication can often increase the level of "bad" fats||
1039|067|S|(cholesterol/triglyceride) in your blood. Your doctor will order||
1039|068|S|blood tests to measure these fats. If your blood fat levels get||
1039|069|S|too high, your bexarotene dose may need to be lowered or stopped,||
1039|070|S|or you may need to start cholesterol medication.||
1039|071|S|   This medication can cause an underactive thyroid||
1039|072|S|(hypothyroidism). Tell your doctor right away if any of these||
1039|073|S|symptoms of low thyroid occur: unusual weight gain, feeling cold,||
1039|074|S|constipation, slow heartbeat, low on energy. Your doctor will||
1039|075|S|order a blood test and may start you on thyroid medication.||
1039|076|S|   Tell your doctor right away if you have any serious side||
1039|077|S|effects, including: swelling of the hands/feet, muscle||
1039|078|S|pain/stiffness/cramps, fast/pounding heartbeat, mental/mood||
1039|079|S|changes (such as depression, anxiety, thoughts of suicide),||
1039|080|S|nausea/vomiting that doesn't stop, stomach/abdominal/back pain,||
1039|081|S|dark urine, vision changes, yellowing eyes/skin.||
1039|082|S|   This medication can lower the body's ability to fight an||
1039|083|S|infection. Tell your doctor right away if you have any signs of||
1039|084|S|an infection (such as sore throat that doesn't go away, fever,||
1039|085|S|chills).||
1039|086|S|   A very serious allergic reaction to this drug is rare.||
1039|087|S|However, get medical help right away if you notice any symptoms||
1039|088|S|of a serious allergic reaction, including: rash, itching/swelling||
1039|089|S|(especially of the face/tongue/throat), dizziness, trouble||
1039|090|S|breathing.||
1039|091|S|   This is not a complete list of possible side effects. If you||
1039|092|S|notice other effects not listed above, contact your doctor or||
1039|093|S|pharmacist.||
1039|094|S|   In the US -||
1039|095|S|   Call your doctor for medical advice about side effects. You||
1039|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1039|097|S|www.fda.gov/medwatch.||
1039|098|S|   In Canada - Call your doctor for medical advice about side||
1039|099|S|effects. You may report side effects to Health Canada at||
1039|100|S|1-866-234-2345.||
1039|101|B|||
1039|102|P|PRECAUTIONS:  Before taking bexarotene, tell your doctor or||
1039|103|P|pharmacist if you are allergic to it; or to vitamin A-related||
1039|104|P|drugs (other retinoids such as isotretinoin); or if you have any||
1039|105|P|other allergies. This product may contain inactive ingredients,||
1039|106|P|which can cause allergic reactions or other problems. Talk to||
1039|107|P|your pharmacist for more details.||
1039|108|P|   Before using this medication, tell your doctor or pharmacist||
1039|109|P|your medical history, especially of: pancreatitis, frequent||
1039|110|P|alcohol use, cataracts, high blood fats (high||
1039|111|P|cholesterol/triglyceride), diabetes, gallbladder disease, liver||
1039|112|P|problems, mental/mood problems (such as depression), thyroid||
1039|113|P|problems (such as hypothyroidism).||
1039|114|P|   This medication may make you more sensitive to the sun. Limit||
1039|115|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1039|116|P|sunscreen and wear protective clothing when outdoors. Tell your||
1039|117|P|doctor right away if you get sunburned or have skin||
1039|118|P|blisters/redness.||
1039|119|P|   Bexarotene can make you more likely to get infections or may||
1039|120|P|make current infections worse. Stay away from anyone who has an||
1039|121|P|infection that may easily spread (such as chickenpox, COVID-19,||
1039|122|P|measles, flu). Talk to your doctor if you have been exposed to an||
1039|123|P|infection or for more details.||
1039|124|P|   This medication must not be used during pregnancy. If you||
1039|125|P|become pregnant or think you may be pregnant, inform your doctor||
1039|126|P|right away. (See also Warning section.)||
1039|127|P|   Since this drug can be absorbed through the skin and lungs and||
1039|128|P|may harm an unborn baby, women who are pregnant or who may become||
1039|129|P|pregnant should not handle this medication or breathe the dust||
1039|130|P|from the capsules.||
1039|131|P|   It is unknown if this medication passes into breast milk.||
1039|132|P|Because of the possible risk to the infant, breastfeeding is not||
1039|133|P|recommended while using this medication. Consult your doctor||
1039|134|P|before breastfeeding.||
1039|135|B|||
1039|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1039|137|I|medications work or increase your risk for serious side effects.||
1039|138|I|This document does not contain all possible drug interactions.||
1039|139|I|Keep a list of all the products you use (including||
1039|140|I|prescription/nonprescription drugs and herbal products) and share||
1039|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
1039|142|I|the dosage of any medicines without your doctor's approval.||
1039|143|I|   Some products that may interact with this drug are:||
1039|144|I|gemfibrozil, tamoxifen, vitamins/supplements that contain vitamin||
1039|145|I|A.||
1039|146|I|   This medication may decrease the effectiveness of hormonal||
1039|147|I|birth control such as pills, patch, or ring. This could cause||
1039|148|I|pregnancy. Discuss with your doctor or pharmacist about using a||
1039|149|I|reliable backup birth control method while using this medication.||
1039|150|I|Also tell your doctor if you have any new spotting or||
1039|151|I|breakthrough bleeding, because these may be signs that your birth||
1039|152|I|control is not working well. See also Warning section.||
1039|153|I|   This medication may interfere with certain lab tests (such as||
1039|154|I|CA-125 levels), possibly causing false test results. Make sure||
1039|155|I|lab personnel and all your doctors know you use this drug.||
1039|156|B|||
1039|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1039|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1039|159|O|poison control center right away. US residents can call||
1039|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1039|161|B|||
1039|162|N|NOTES:  Do not share this medication with others.||
1039|163|N|   Lab and/or medical tests (such as pregnancy tests,||
1039|164|N|liver/thyroid function, cholesterol/triglyceride levels, white||
1039|165|N|blood count) should be done while you are taking this medication.||
1039|166|N|Keep all medical and lab appointments. Consult your doctor for||
1039|167|N|more details.||
1039|168|B|||
1039|169|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
1039|170|D|you remember. If it is near the time of the next dose, skip the||
1039|171|D|missed dose. Take your next dose at the regular time. Do not||
1039|172|D|double the dose to catch up.||
1039|173|B|||
1039|174|R|STORAGE:  Store at room temperature or in the refrigerator away||
1039|175|R|from light and moisture. Do not store in the bathroom. Keep all||
1039|176|R|medications away from children and pets.||
1039|177|R|   Do not flush medications down the toilet or pour them into a||
1039|178|R|drain unless instructed to do so. Properly discard this product||
1039|179|R|when it is expired or no longer needed. Consult your pharmacist||
1039|180|R|or local waste disposal company.||
1039|181|B|||
1039|182|M|MEDICAL ALERT:  Your condition can cause complications in a||
1039|183|M|medical emergency. For information about enrolling in MedicAlert,||
1039|184|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1039|185|B|||
1039|186|A|Information last revised April 2025.||
1039|187|A|Copyright(c) 2025 First Databank, Inc.||
1039|188|B|||
1041|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1041|002|Z|does NOT have all possible information about this product. This||
1041|003|Z|information does not assure that this product is safe, effective,||
1041|004|Z|or appropriate for you. This information is not individual||
1041|005|Z|medical advice and does not substitute for the advice of your||
1041|006|Z|health care professional. Always ask your health care||
1041|007|Z|professional for complete information about this product and your||
1041|008|Z|specific health needs.||
1041|009|B|||
1041|010|T|CARBIDOPA - ORAL||
1041|011|F|(KAR-bi-DOE-pa)||
1041|012|B|||
1041|013|C|COMMON BRAND NAME(S): Lodosyn||
1041|014|B|||
1041|015|U|USES:  This medication is used with a combination||
1041|016|U|levodopa/carbidopa product to treat symptoms of Parkinson's||
1041|017|U|disease or Parkinson-like symptoms (such as shakiness, stiffness,||
1041|018|U|difficulty moving). Carbidopa must be taken together with a drug||
1041|019|U|that contains levodopa to be effective. If used alone, carbidopa||
1041|020|U|has no effect on Parkinson's symptoms. Parkinson's disease is||
1041|021|U|thought to be caused by too little of a naturally occurring||
1041|022|U|substance (dopamine) in the brain. Levodopa changes into dopamine||
1041|023|U|in the brain, helping to control movement. Carbidopa prevents the||
1041|024|U|breakdown of levodopa in the bloodstream so more levodopa can||
1041|025|U|enter the brain. Carbidopa can also reduce some of levodopa's||
1041|026|U|side effects such as nausea and vomiting.||
1041|027|B|||
1041|028|H|HOW TO USE:  Take this medication by mouth with or without food||
1041|029|H|as directed by your doctor. You may be directed to take this||
1041|030|H|medication with one, some, or all of your levodopa/carbidopa||
1041|031|H|doses. Follow your doctor's instructions carefully. The dosage is||
1041|032|H|based on your medical condition and response to treatment.||
1041|033|H|   Since this medication is always taken with a||
1041|034|H|levodopa-containing product, it is best to avoid a high-protein||
1041|035|H|diet (it decreases the amount of levodopa that your body takes||
1041|036|H|in) during treatment, unless directed otherwise by your doctor.||
1041|037|H|Separate your dose of this medication by as many hours as||
1041|038|H|possible from any iron supplements or products containing iron||
1041|039|H|(such as multivitamins with minerals) you may take. Iron can||
1041|040|H|reduce the amount of levodopa absorbed by the body. Consult your||
1041|041|H|doctor or pharmacist for more details.||
1041|042|H|   Use this medication regularly to get the most benefit from it.||
1041|043|H|To help you remember, take it at the same time(s) each day.||
1041|044|H|   Some patients may experience a "wearing-off" (worsening of||
1041|045|H|symptoms) before the next dose is due. An "on-off" effect might||
1041|046|H|also occur, in which sudden short periods of stiffness occur. If||
1041|047|H|these effects occur, contact your doctor for possible dose||
1041|048|H|adjustments that may help to lessen this effect.||
1041|049|H|   Do not stop taking this medication and the levodopa-containing||
1041|050|H|product without consulting your doctor. Some conditions may||
1041|051|H|become worse when these drugs are quickly reduced or suddenly||
1041|052|H|stopped. Your dose may need to be gradually reduced. (See also||
1041|053|H|Side Effects section.)||
1041|054|H|   Tell your doctor if your condition does not get better or if||
1041|055|H|it gets worse.||
1041|056|B|||
1041|057|S|SIDE EFFECTS:  Side effects with carbidopa are rare and usually||
1041|058|S|occur due to the levodopa-containing product that is taken||
1041|059|S|together with it. The following side effects in this section may||
1041|060|S|occur due to levodopa.||
1041|061|S|   Dizziness, lightheadedness, nausea, vomiting, loss of||
1041|062|S|appetite, trouble sleeping, unusual dreams, or headache may||
1041|063|S|occur. If any of these effects last or get worse, tell your||
1041|064|S|doctor or pharmacist promptly.||
1041|065|S|   This medication (or levodopa) may cause saliva, urine, or||
1041|066|S|sweat to turn a dark color. This effect is harmless, but your||
1041|067|S|clothes may be stained.||
1041|068|S|   To reduce the risk of dizziness and lightheadedness, get up||
1041|069|S|slowly when rising from a sitting or lying position.||
1041|070|S|   Remember that this medication has been prescribed because your||
1041|071|S|doctor has judged that the benefit to you is greater than the||
1041|072|S|risk of side effects. Many people using this medication do not||
1041|073|S|have serious side effects.||
1041|074|S|   Some people taking this medication along with||
1041|075|S|levodopa/carbidopa have fallen asleep suddenly during their usual||
1041|076|S|daily activities (such as talking on the phone, driving). In some||
1041|077|S|cases, sleep occurred without any feelings of drowsiness||
1041|078|S|beforehand. This sleep effect may occur anytime during treatment||
1041|079|S|with carbidopa and levodopa/carbidopa even if you have used these||
1041|080|S|medications for a long time. If you experience increased||
1041|081|S|sleepiness or fall asleep during the day, do not drive or do||
1041|082|S|other possibly dangerous activities until you have discussed this||
1041|083|S|effect with your doctor. Your risk of this sleep effect is||
1041|084|S|increased by using alcohol or other medications that can make you||
1041|085|S|drowsy. See also Precautions section.||
1041|086|S|   Tell your doctor right away if you have any serious side||
1041|087|S|effects, including: new/worsening movements you can't||
1041|088|S|control/spasms, greatly increased eye blinking/twitching, vision||
1041|089|S|changes (such as blurred/double vision), eye pain, severe||
1041|090|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
1041|091|S|coffee grounds, mental/mood changes (such as agitation,||
1041|092|S|hallucinations, depression, thoughts of suicide), signs of||
1041|093|S|infection (such as sore throat that doesn't go away, fever,||
1041|094|S|chills), easy bleeding/bruising, unusual tiredness, tingling of||
1041|095|S|the hands/feet, unusual strong urges (such as increased gambling,||
1041|096|S|increased sexual urges).||
1041|097|S|   Get medical help right away if you have any very serious side||
1041|098|S|effects, including: chest pain, fainting.||
1041|099|S|   Abruptly stopping or reducing the dose of this medication and||
1041|100|S|levodopa/carbidopa may rarely cause a serious condition called||
1041|101|S|neuroleptic malignant syndrome (NMS). Get medical help right away||
1041|102|S|if you have any of the following symptoms: fever, unusual muscle||
1041|103|S|stiffness, severe confusion, sweating, fast/irregular heartbeat.||
1041|104|S|   A very serious allergic reaction to this drug is rare.||
1041|105|S|However, get medical help right away if you notice any symptoms||
1041|106|S|of a serious allergic reaction, including: rash, itching/swelling||
1041|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1041|108|S|breathing.||
1041|109|S|   This is not a complete list of possible side effects. If you||
1041|110|S|notice other effects not listed above, contact your doctor or||
1041|111|S|pharmacist.||
1041|112|S|   In the US -||
1041|113|S|   Call your doctor for medical advice about side effects. You||
1041|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1041|115|S|www.fda.gov/medwatch.||
1041|116|S|   In Canada - Call your doctor for medical advice about side||
1041|117|S|effects. You may report side effects to Health Canada at||
1041|118|S|1-866-234-2345.||
1041|119|B|||
1041|120|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1041|121|P|pharmacist if you are allergic to it; or to foscarbidopa; or if||
1041|122|P|you have any other allergies. This product may contain inactive||
1041|123|P|ingredients, which can cause allergic reactions or other||
1041|124|P|problems. Talk to your pharmacist for more details.||
1041|125|P|   Before using this medication, tell your doctor or pharmacist||
1041|126|P|your medical history, especially of: liver disease, glaucoma,||
1041|127|P|breathing problems (such as asthma), heart disease (such as heart||
1041|128|P|attack, irregular heartbeat), kidney disease, stomach/intestinal||
1041|129|P|ulcer, mental/mood disorders (such as depression, schizophrenia),||
1041|130|P|blood disorders, seizures, sleep disorder.||
1041|131|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1041|132|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1041|133|P|machinery, or do anything that needs alertness until you can do||
1041|134|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1041|135|P|are using marijuana (cannabis). See also Side Effects section.||
1041|136|P|   Before having surgery, tell your doctor or dentist about all||
1041|137|P|the products you use (including prescription drugs,||
1041|138|P|nonprescription drugs, and herbal products).||
1041|139|P|   During pregnancy, this medication should be used only when||
1041|140|P|clearly needed. Discuss the risks and benefits with your doctor.||
1041|141|P|   It is unknown if this medication passes into breast milk.||
1041|142|P|Consult your doctor before breastfeeding.||
1041|143|B|||
1041|144|I|DRUG INTERACTIONS:  See also How to Use section.||
1041|145|I|   Drug interactions may change how your medications work or||
1041|146|I|increase your risk for serious side effects. This document does||
1041|147|I|not contain all possible drug interactions. Keep a list of all||
1041|148|I|the products you use (including prescription/nonprescription||
1041|149|I|drugs and herbal products) and share it with your doctor and||
1041|150|I|pharmacist. Do not start, stop, or change the dosage of any||
1041|151|I|medicines without your doctor's approval.||
1041|152|I|   Some products that may interact with this drug (or levodopa)||
1041|153|I|include: certain drugs used to treat high blood pressure (such as||
1041|154|I|methyldopa), tetrabenazine.||
1041|155|I|   Taking MAO inhibitors with this medication (along with a||
1041|156|I|levodopa-containing product) may cause a serious (possibly fatal)||
1041|157|I|drug interaction. Avoid taking MAO inhibitors (isocarboxazid,||
1041|158|I|linezolid, metaxalone, methylene blue, moclobemide, phenelzine,||
1041|159|I|procarbazine, tranylcypromine) during treatment with this||
1041|160|I|medication. Most MAO inhibitors should also not be taken for two||
1041|161|I|weeks before treatment with this medication. However, certain MAO||
1041|162|I|inhibitors (rasagiline, safinamide, selegiline) may be used with||
1041|163|I|careful monitoring by your doctor. Ask your doctor when to start||
1041|164|I|or stop taking this medication.||
1041|165|I|   This medication (or levodopa) may interfere with certain lab||
1041|166|I|tests (such as urine catecholamine/glucose/ketone tests),||
1041|167|I|possibly causing false test results. Make sure lab personnel and||
1041|168|I|all your doctors know you use this drug.||
1041|169|B|||
1041|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1041|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1041|172|O|poison control center right away. US residents can call||
1041|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1041|174|B|||
1041|175|N|NOTES:  Do not share this medication with others.||
1041|176|N|   Lab and/or medical tests (such as complete blood count,||
1041|177|N|heart/kidney/liver function, blood pressure) should be done while||
1041|178|N|you are taking this medication. Keep all medical and lab||
1041|179|N|appointments. Consult your doctor for more details.||
1041|180|B|||
1041|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1041|182|D|remember. If it is near the time of the next dose, skip the||
1041|183|D|missed dose. Take your next dose at the regular time. Do not||
1041|184|D|double the dose to catch up.||
1041|185|B|||
1041|186|R|STORAGE:  Store at room temperature away from light and moisture.||
1041|187|R|Do not store in the bathroom. Keep all medications away from||
1041|188|R|children and pets.||
1041|189|R|   Do not flush medications down the toilet or pour them into a||
1041|190|R|drain unless instructed to do so. Properly discard this product||
1041|191|R|when it is expired or no longer needed. Consult your pharmacist||
1041|192|R|or local waste disposal company.||
1041|193|B|||
1041|194|A|Information last revised April 2025.||
1041|195|A|Copyright(c) 2025 First Databank, Inc.||
1041|196|B|||
1042|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1042|002|Z|does NOT have all possible information about this product. This||
1042|003|Z|information does not assure that this product is safe, effective,||
1042|004|Z|or appropriate for you. This information is not individual||
1042|005|Z|medical advice and does not substitute for the advice of your||
1042|006|Z|health care professional. Always ask your health care||
1042|007|Z|professional for complete information about this product and your||
1042|008|Z|specific health needs.||
1042|009|B|||
1042|010|T|IXABEPILONE - INJECTION||
1042|011|F|(IX-a-BEP-i-lone)||
1042|012|B|||
1042|013|C|COMMON BRAND NAME(S): Ixempra||
1042|014|B|||
1042|015|W|WARNING:  Ixabepilone should not be used with capecitabine if||
1042|016|W|blood tests show you have liver problems. Using these 2||
1042|017|W|medications together may increase the risk of severe (sometimes||
1042|018|W|fatal) immune problems and serious infection.||
1042|019|B|||
1042|020|U|USES:  This medication is used to treat advanced breast cancer.||
1042|021|U|Ixabepilone is a chemotherapy drug that works to slow or stop||
1042|022|U|cancer cell growth.||
1042|023|B|||
1042|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1042|025|H|from your pharmacist before you start using ixabepilone and each||
1042|026|H|time you receive a dose. If you have any questions, ask your||
1042|027|H|doctor or pharmacist.||
1042|028|H|   This medication is usually given by injection into a vein over||
1042|029|H|3 hours by a health care professional. It is given as directed by||
1042|030|H|your doctor, usually every 3 weeks. You will need blood tests||
1042|031|H|(complete blood count) before each appointment. Your doctor will||
1042|032|H|adjust the dosage and how often you receive the medication based||
1042|033|H|on the blood tests.||
1042|034|H|   Your doctor will direct you to take 2 types of antihistamines||
1042|035|H|(such as diphenhydramine and ranitidine) by mouth 1 hour before||
1042|036|H|your treatment to prevent or lessen a severe allergic reaction.||
1042|037|H|Your doctor may give you another medication (a corticosteroid||
1042|038|H|such as dexamethasone) and give ixabepilone over more than 3||
1042|039|H|hours if you had a severe reaction during your last treatment.||
1042|040|H|   The dosage is based on your medical condition, body size, and||
1042|041|H|response to treatment.||
1042|042|B|||
1042|043|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
1042|044|S|weakness, tiredness, muscle/joint pain, nausea, vomiting,||
1042|045|S|diarrhea, loss of appetite, headache, dizziness, or drowsiness||
1042|046|S|may occur. Nausea and vomiting may be severe in some patients.||
1042|047|S|Your doctor may prescribe medication to prevent or relieve nausea||
1042|048|S|and vomiting. Eating several small meals, not eating before||
1042|049|S|treatment, or limiting activity may help lessen some of these||
1042|050|S|effects. If any of these effects last or get worse, tell your||
1042|051|S|doctor or pharmacist promptly.||
1042|052|S|   Temporary hair loss may occur. Normal hair growth should||
1042|053|S|return after treatment has ended.||
1042|054|S|   People using this medication may have serious side effects.||
1042|055|S|However, you have been prescribed this drug because your doctor||
1042|056|S|has judged that the benefit to you is greater than the risk of||
1042|057|S|side effects. Careful monitoring by your doctor may decrease your||
1042|058|S|risk.||
1042|059|S|   This medication can lower your body's ability to fight an||
1042|060|S|infection. Tell your doctor right away if you develop any signs||
1042|061|S|of an infection (such as sore throat that doesn't go away,||
1042|062|S|painful urination, fever, chills).||
1042|063|S|   Painful sores on the lips, mouth, and throat may occur. To||
1042|064|S|decrease the risk, limit hot foods and drinks, brush your teeth||
1042|065|S|carefully, avoid using mouthwash that contains alcohol, and rinse||
1042|066|S|your mouth often with cool water.||
1042|067|S|   Tell your doctor right away if you have any serious side||
1042|068|S|effects, including: swollen hands/ankles/feet, fainting, pale||
1042|069|S|skin, easy/unusual bruising/bleeding, sudden weight gain, signs||
1042|070|S|of dehydration (such as decreased urination, increased thirst,||
1042|071|S|dry mouth).||
1042|072|S|   Ixabepilone can sometimes affect how your nerves work||
1042|073|S|(peripheral neuropathy). Tell your doctor right away if you||
1042|074|S|develop pain/burning/numbness/tingling of the hands/feet.||
1042|075|S|   You may lessen these types of nerve problems by avoiding cold||
1042|076|S|drinks and ice and by dressing warmly. Tell your doctor right||
1042|077|S|away if your nerve problems begin to interfere with your normal||
1042|078|S|daily activities (such as walking, writing, eating).||
1042|079|S|   Treatment with ixabepilone may sometimes cause your hands/feet||
1042|080|S|to develop a skin reaction called hand-foot syndrome||
1042|081|S|(palmar-plantar erythrodysesthesia), especially when this drug is||
1042|082|S|given with capecitabine. You can prevent or reduce these problems||
1042|083|S|by protecting your hands and feet from a great deal of heat or||
1042|084|S|pressure. Avoid unnecessary exposure to heat (such as hot||
1042|085|S|dishwater, long hot baths). Avoid pressure on elbows, knees, and||
1042|086|S|soles of feet (such as leaning on elbows, kneeling, long walks).||
1042|087|S|Wear loose clothing. Depending on how severe your hand-foot||
1042|088|S|syndrome is, your doctor may prescribe a medication to reduce the||
1042|089|S|symptoms or decrease/delay your next treatment. If you experience||
1042|090|S|pain/swelling/redness, blisters, or numbness of the hands/feet||
1042|091|S|that affects your usual activities, tell your doctor right away.||
1042|092|S|   Get medical help right away if you have any very serious side||
1042|093|S|effects, including: fast/irregular heartbeat, shortness of||
1042|094|S|breath, chest pain, bloody/black stools, vomit that looks like||
1042|095|S|coffee grounds, vision changes, seizures, sudden confusion.||
1042|096|S|   A very serious allergic reaction to this drug is rare.||
1042|097|S|However, get medical help right away if you notice any symptoms||
1042|098|S|of a serious allergic reaction, including: rash, itching/swelling||
1042|099|S|(especially of the face/tongue/throat), face flushing, tight||
1042|100|S|feeling in chest, severe dizziness, trouble breathing.||
1042|101|S|   This is not a complete list of possible side effects. If you||
1042|102|S|notice other effects not listed above, contact your doctor or||
1042|103|S|pharmacist.||
1042|104|S|   In the US -||
1042|105|S|   Call your doctor for medical advice about side effects. You||
1042|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1042|107|S|www.fda.gov/medwatch.||
1042|108|S|   In Canada - Call your doctor for medical advice about side||
1042|109|S|effects. You may report side effects to Health Canada at||
1042|110|S|1-866-234-2345.||
1042|111|B|||
1042|112|P|PRECAUTIONS:  Before using ixabepilone, tell your doctor or||
1042|113|P|pharmacist if you are allergic to it; or if you have any other||
1042|114|P|allergies. This product may contain inactive ingredients (such as||
1042|115|P|polyoxyethylated castor oil), which can cause allergic reactions||
1042|116|P|or other problems. Talk to your pharmacist for more details.||
1042|117|P|   Before using this medication, tell your doctor or pharmacist||
1042|118|P|your medical history, especially of: bleeding problems, diabetes,||
1042|119|P|heart problems (such as chest pain, heart failure, heart attack),||
1042|120|P|liver problems, bone marrow problems (such as low white count,||
1042|121|P|anemia), nerve problem (peripheral neuropathy).||
1042|122|P|   This medication contains alcohol. It may make you dizzy or||
1042|123|P|drowsy. Marijuana (cannabis) can make you more dizzy or drowsy.||
1042|124|P|Do not drive, use machinery, or do anything that needs alertness||
1042|125|P|until you can do it safely. Limit alcoholic beverages. Talk to||
1042|126|P|your doctor if you are using marijuana (cannabis).||
1042|127|P|   Tell your health care professional that you are using||
1042|128|P|ixabepilone before having any immunizations/vaccinations. Avoid||
1042|129|P|contact with people who have recently received live vaccines||
1042|130|P|(such as flu vaccine inhaled through the nose).||
1042|131|P|   To lower your risk of getting cut, bruised, or injured, use||
1042|132|P|caution with sharp objects like razors and nail cutters, and||
1042|133|P|avoid activities such as contact sports.||
1042|134|P|   Tell your doctor if you are pregnant or plan to become||
1042|135|P|pregnant. You should not become pregnant while using ixabepilone.||
1042|136|P|Ixabepilone may harm an unborn baby. Your doctor should order a||
1042|137|P|pregnancy test before you start this medication. Women using this||
1042|138|P|medication should ask about reliable forms of birth control||
1042|139|P|during treatment and for 7 months after the last dose. Men using||
1042|140|P|this medication should ask about reliable forms of birth control||
1042|141|P|during treatment and for 4 months after the last dose. If you or||
1042|142|P|your partner becomes pregnant, talk to your doctor right away||
1042|143|P|about the risks and benefits of this medication.||
1042|144|P|   It is unknown if this drug passes into breast milk. Because of||
1042|145|P|the possible risk to the infant, breastfeeding is not recommended||
1042|146|P|while using this drug and for at least 2 weeks after the last||
1042|147|P|dose. Consult your doctor before breastfeeding.||
1042|148|B|||
1042|149|I|DRUG INTERACTIONS:  See also Warning section.||
1042|150|I|   Drug interactions may change how your medications work or||
1042|151|I|increase your risk for serious side effects. This document does||
1042|152|I|not contain all possible drug interactions. Keep a list of all||
1042|153|I|the products you use (including prescription/nonprescription||
1042|154|I|drugs and herbal products) and share it with your doctor and||
1042|155|I|pharmacist. Do not start, stop, or change the dosage of any||
1042|156|I|medicines without your doctor's approval.||
1042|157|I|   Some products that may interact with this drug include: drugs||
1042|158|I|that cause a reaction with alcohol (such as disulfiram,||
1042|159|I|metronidazole).||
1042|160|I|   Other medications can affect the removal of ixabepilone from||
1042|161|I|your body, which may affect how ixabepilone works. Examples||
1042|162|I|include azole antifungals (such as itraconazole, ketoconazole),||
1042|163|I|macrolide antibiotics (such as clarithromycin, erythromycin),||
1042|164|I|rifamycins (such as rifabutin), ritonavir, St. John's wort, drugs||
1042|165|I|used to treat seizures (such as carbamazepine, phenytoin), among||
1042|166|I|others.||
1042|167|I|   Tell your doctor or pharmacist if you are taking other||
1042|168|I|products that cause drowsiness including alcohol, marijuana||
1042|169|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1042|170|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1042|171|I|zolpidem), muscle relaxants (such as carisoprodol,||
1042|172|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
1042|173|I|hydrocodone).||
1042|174|I|   Check the labels on all your medicines (such as allergy or||
1042|175|I|cough-and-cold products) because they may contain ingredients||
1042|176|I|that cause drowsiness. Ask your pharmacist about using those||
1042|177|I|products safely.||
1042|178|B|||
1042|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1042|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1042|181|O|poison control center right away. US residents can call||
1042|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1042|183|B|||
1042|184|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1042|185|N|liver function) should be done while you are using this||
1042|186|N|medication. Keep all medical and lab appointments. Consult your||
1042|187|N|doctor for more details.||
1042|188|B|||
1042|189|D|MISSED DOSE:  It is important to get each dose of this medication||
1042|190|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1042|191|D|right away for a new dosing schedule.||
1042|192|B|||
1042|193|R|STORAGE:  Not applicable. This medication is given in a clinic||
1042|194|R|and will not be stored at home.||
1042|195|B|||
1042|196|M|MEDICAL ALERT:  Your condition can cause complications in a||
1042|197|M|medical emergency. For information about enrolling in MedicAlert,||
1042|198|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1042|199|B|||
1042|200|A|Information last revised April 2025.||
1042|201|A|Copyright(c) 2025 First Databank, Inc.||
1042|202|B|||
1043|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1043|002|Z|does NOT have all possible information about this product. This||
1043|003|Z|information does not assure that this product is safe, effective,||
1043|004|Z|or appropriate for you. This information is not individual||
1043|005|Z|medical advice and does not substitute for the advice of your||
1043|006|Z|health care professional. Always ask your health care||
1043|007|Z|professional for complete information about this product and your||
1043|008|Z|specific health needs.||
1043|009|B|||
1043|010|T|FUROSEMIDE 500 MG TABLET - ORAL||
1043|011|F|(fyou-ROW-seh-mide)||
1043|012|B|||
1043|013|W|WARNING:  This is a very potent medication. Using too much of||
1043|014|W|this drug can lead to serious water and mineral loss. It is||
1043|015|W|important that you are closely monitored by your doctor. Tell||
1043|016|W|your doctor right away if you become very thirsty or confused, or||
1043|017|W|develop muscle cramps/weakness while taking this medication.||
1043|018|W|   See also Side Effects section.||
1043|019|B|||
1043|020|U|USES:  Furosemide is a "water pill" (diuretic) that increases the||
1043|021|U|amount of urine you make, which causes your body to get rid of||
1043|022|U|excess water. This drug is used on a short-term basis in a||
1043|023|U|hospital setting. It is used to treat adults with severe kidney||
1043|024|U|disease who have not responded to usual doses of furosemide.||
1043|025|B|||
1043|026|H|HOW TO USE:  Take this medication by mouth with or without food||
1043|027|H|as directed by your doctor, usually for 1 or 2 doses. The dosage||
1043|028|H|is based on your medical condition and response to treatment.||
1043|029|H|   Sucralfate, cholestyramine, and colestipol can decrease the||
1043|030|H|absorption of furosemide. If you are taking any of these drugs,||
1043|031|H|separate them from furosemide by at least 2 hours.||
1043|032|H|   Tell your doctor if your condition lasts or gets worse.||
1043|033|B|||
1043|034|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, blurred||
1043|035|S|vision, loss of appetite, stomach upset, diarrhea, or||
1043|036|S|constipation may occur as your body adjusts to the medication. If||
1043|037|S|any of these effects last or get worse, notify your doctor or||
1043|038|S|pharmacist promptly.||
1043|039|S|   To reduce the risk of dizziness and lightheadedness, get up||
1043|040|S|slowly when rising from a sitting or lying position.||
1043|041|S|   Remember that this medication has been prescribed because your||
1043|042|S|doctor has judged that the benefit to you is greater than the||
1043|043|S|risk of side effects. Many people using this medication do not||
1043|044|S|have serious side effects.||
1043|045|S|   This medication may cause dehydration and electrolyte||
1043|046|S|imbalance. Tell your doctor right away if you have any symptoms||
1043|047|S|of dehydration or electrolyte imbalance, including unusual dry||
1043|048|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
1043|049|S|heartbeat, or confusion.||
1043|050|S|   Tell your doctor right away if you have any serious side||
1043|051|S|effects, including: signs of kidney problems (such as change in||
1043|052|S|the amount of urine), fainting, numbness/tingling of the||
1043|053|S|arms/legs, ringing in the ears, hearing loss, signs of liver||
1043|054|S|problems (such as stomach/abdominal pain, yellowing eyes/skin).||
1043|055|S|   A very serious allergic reaction to this drug is rare.||
1043|056|S|However, get medical help right away if you notice any symptoms||
1043|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1043|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1043|059|S|breathing.||
1043|060|S|   This is not a complete list of possible side effects. If you||
1043|061|S|notice other effects not listed above, contact your doctor or||
1043|062|S|pharmacist.||
1043|063|S|   In the US -||
1043|064|S|   Call your doctor for medical advice about side effects. You||
1043|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1043|066|S|www.fda.gov/medwatch.||
1043|067|S|   In Canada - Call your doctor for medical advice about side||
1043|068|S|effects. You may report side effects to Health Canada at||
1043|069|S|1-866-234-2345.||
1043|070|B|||
1043|071|P|PRECAUTIONS:  Before taking furosemide, tell your doctor or||
1043|072|P|pharmacist if you are allergic to it; or if you have any other||
1043|073|P|allergies. This product may contain inactive ingredients, which||
1043|074|P|can cause allergic reactions or other problems. Talk to your||
1043|075|P|pharmacist for more details.||
1043|076|P|   Before using this medication, tell your doctor or pharmacist||
1043|077|P|your medical history, especially of: kidney disease, liver||
1043|078|P|disease, gout, lupus.||
1043|079|P|   If you have diabetes, furosemide may make it harder to control||
1043|080|P|your blood sugar. Check your blood sugar regularly as directed||
1043|081|P|and share the results with your doctor.||
1043|082|P|   This drug may reduce the potassium levels in your blood. Ask||
1043|083|P|your doctor about adding potassium to your diet. A potassium||
1043|084|P|supplement may be prescribed by your doctor.||
1043|085|P|   This medication may make you more sensitive to the sun. Limit||
1043|086|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1043|087|P|sunscreen and wear protective clothing when outdoors. Tell your||
1043|088|P|doctor right away if you get sunburned or have skin||
1043|089|P|blisters/redness.||
1043|090|P|   This drug may make you dizzy or drowsy or blur your vision.||
1043|091|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1043|092|P|drowsy. Do not drive, use machinery, or do anything that needs||
1043|093|P|alertness or clear vision until you can do it safely. Limit||
1043|094|P|alcoholic beverages. Talk to your doctor if you are using||
1043|095|P|marijuana (cannabis).||
1043|096|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1043|097|P|and cause you to feel lightheaded. Tell your doctor if you have||
1043|098|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1043|099|P|of fluids unless your doctor tells you not to.||
1043|100|P|   Before having surgery, tell your doctor or dentist about all||
1043|101|P|the products you use (including prescription drugs,||
1043|102|P|nonprescription drugs, and herbal products). Your doctor may tell||
1043|103|P|you to temporarily stop treatment with this medication before||
1043|104|P|certain medical, surgical, or dental procedures.||
1043|105|P|   Older adults may be more sensitive to the side effects of this||
1043|106|P|drug, especially dizziness and water/mineral loss.||
1043|107|P|   During pregnancy, furosemide should be used only when clearly||
1043|108|P|needed. Discuss the risks and benefits with your doctor.||
1043|109|P|   This drug passes into breast milk. Consult your doctor before||
1043|110|P|breastfeeding.||
1043|111|B|||
1043|112|I|DRUG INTERACTIONS:  See also the How to Use section.||
1043|113|I|   Drug interactions may change how your medications work or||
1043|114|I|increase your risk for serious side effects. This document does||
1043|115|I|not contain all possible drug interactions. Keep a list of all||
1043|116|I|the products you use (including prescription/nonprescription||
1043|117|I|drugs and herbal products) and share it with your doctor and||
1043|118|I|pharmacist. Do not start, stop, or change the dosage of any||
1043|119|I|medicines without your doctor's approval.||
1043|120|I|   Some products that may interact with this drug include:||
1043|121|I|desmopressin, ethacrynic acid, lithium.||
1043|122|I|   Some products have ingredients that could raise your blood||
1043|123|I|pressure or worsen your swelling. Tell your pharmacist what||
1043|124|I|products you are using, and ask how to use them safely||
1043|125|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
1043|126|I|ibuprofen/naproxen).||
1043|127|I|   This medication may interfere with certain lab tests (such as||
1043|128|I|thyroid hormone levels), possibly causing false test results.||
1043|129|I|Make sure lab personnel and all your doctors know you use this||
1043|130|I|drug.||
1043|131|B|||
1043|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1043|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1043|134|O|poison control center right away. US residents can call||
1043|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1043|136|B|||
1043|137|N|NOTES:  Do not share this medication with others.||
1043|138|N|   Lab and/or medical tests (such as kidney function, blood||
1043|139|N|mineral levels such as sodium/potassium) should be done while you||
1043|140|N|are using this medication. Consult your doctor for more details.||
1043|141|N|   Have your blood pressure checked regularly while taking this||
1043|142|N|medication. Discuss with your doctor how to monitor your own||
1043|143|N|blood pressure.||
1043|144|B|||
1043|145|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1043|146|D|If it is near the time of the next dose, skip the missed dose.||
1043|147|D|Use your next dose at the regular time. Do not double the dose to||
1043|148|D|catch up.||
1043|149|B|||
1043|150|R|STORAGE:  Store at room temperature away from light and moisture.||
1043|151|R|Do not store in the bathroom. Keep all medications away from||
1043|152|R|children and pets.||
1043|153|R|   Do not flush medications down the toilet or pour them into a||
1043|154|R|drain unless instructed to do so. Properly discard this product||
1043|155|R|when it is expired or no longer needed. Consult your pharmacist||
1043|156|R|or local waste disposal company.||
1043|157|B|||
1043|158|A|Information last revised October 2024.||
1043|159|A|Copyright(c) 2025 First Databank, Inc.||
1043|160|B|||
1044|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1044|002|Z|does NOT have all possible information about this product. This||
1044|003|Z|information does not assure that this product is safe, effective,||
1044|004|Z|or appropriate for you. This information is not individual||
1044|005|Z|medical advice and does not substitute for the advice of your||
1044|006|Z|health care professional. Always ask your health care||
1044|007|Z|professional for complete information about this product and your||
1044|008|Z|specific health needs.||
1044|009|B|||
1044|010|T|NILOTINIB CAPSULE - ORAL||
1044|011|F|(nye-LOE-ti-nib)||
1044|012|B|||
1044|013|C|COMMON BRAND NAME(S): Tasigna||
1044|014|B|||
1044|015|W|WARNING:  This drug can rarely cause serious (possibly fatal)||
1044|016|W|irregular heartbeats (QT prolongation). Nilotinib should not be||
1044|017|W|used by people with low blood levels of certain minerals||
1044|018|W|(potassium, magnesium) or a certain heart problem (long QT||
1044|019|W|syndrome). To lower your risk, your doctor will order certain||
1044|020|W|blood tests (potassium/magnesium levels, liver function tests)||
1044|021|W|before and during treatment with nilotinib. You should have a||
1044|022|W|heart test (EKG) before starting nilotinib. The EKG should be||
1044|023|W|repeated 7 days after your first dose, when your dose is changed,||
1044|024|W|and periodically while you are taking nilotinib.||
1044|025|W|   To decrease the risk of this effect, do not eat for 2 hours||
1044|026|W|before or 1 hour after taking your dose. Foods/other drugs may||
1044|027|W|increase the risk of an irregular heartbeat. Before taking this||
1044|028|W|drug, tell your doctor or pharmacist of all the products you use.||
1044|029|W|Keep a list of all your medications with you, and share the list||
1044|030|W|with your doctor and pharmacist. See also How to Use and Drug||
1044|031|W|Interactions sections.||
1044|032|W|   Nilotinib may come in different forms (such as tablet,||
1044|033|W|capsule). Do not switch between different forms without||
1044|034|W|consulting your doctor.||
1044|035|B|||
1044|036|U|USES:  Nilotinib is used to treat a certain type of blood cancer||
1044|037|U|(chronic myelogenous leukemia-CML). It works by slowing or||
1044|038|U|stopping the growth of cancer cells.||
1044|039|B|||
1044|040|H|HOW TO USE:  Read the Medication Guide provided by your||
1044|041|H|pharmacist before you start using nilotinib and each time you get||
1044|042|H|a refill. If you have any questions, consult your doctor or||
1044|043|H|pharmacist.||
1044|044|H|   Take this medication by mouth on an empty stomach as directed||
1044|045|H|by your doctor, usually twice daily (about 12 hours apart).||
1044|046|H|Swallow the capsule whole with water. Do not open, break, or chew||
1044|047|H|the capsules. Do not eat any food for at least 2 hours before or||
1044|048|H|for 1 hour after taking your dose. Taking this medication with||
1044|049|H|food can increase the amount of drug in your body and increase||
1044|050|H|the risk of serious side effects.||
1044|051|H|   If you are unable to swallow the capsules, ask your pharmacist||
1044|052|H|if your brand may be opened and sprinkled onto applesauce.||
1044|053|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1044|054|H|using this medication unless your doctor or pharmacist says you||
1044|055|H|may do so safely. Grapefruit can increase the chance of side||
1044|056|H|effects with this medicine. Ask your doctor or pharmacist for||
1044|057|H|more details.||
1044|058|H|   Drink plenty of fluids during treatment with this medication,||
1044|059|H|unless otherwise directed by your doctor.||
1044|060|H|   Medications that reduce stomach acid (such as antacids, proton||
1044|061|H|pump inhibitors/PPIs, H2 blockers) may make nilotinib work less||
1044|062|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
1044|063|H|using this medication. If you take antacids, take them 2 hours||
1044|064|H|before or 2 hours after nilotinib. If you take H2 blockers (such||
1044|065|H|as famotidine, nizatidine), take them 10 hours before or 2 hours||
1044|066|H|after nilotinib.||
1044|067|H|   The dosage is based on your medical condition, response to||
1044|068|H|treatment, lab tests, and other medications you may be taking. Be||
1044|069|H|sure to tell your doctor and pharmacist about all the products||
1044|070|H|you use (including prescription drugs, nonprescription drugs, and||
1044|071|H|herbal products). Children's dosage is also based on body size.||
1044|072|H|   Do not increase your dose or take this medication more often||
1044|073|H|than prescribed. Your condition will not improve any faster, and||
1044|074|H|the risk of serious side effects will increase.||
1044|075|H|   Since this drug can be absorbed through the skin and lungs and||
1044|076|H|may harm an unborn baby, women who are pregnant or who may become||
1044|077|H|pregnant should not handle this medication or breathe the dust||
1044|078|H|from the capsules.||
1044|079|B|||
1044|080|S|SIDE EFFECTS:  See also Warning section.||
1044|081|S|   Nausea, vomiting, headache, tiredness, constipation, or||
1044|082|S|diarrhea may occur. If any of these effects last or get worse,||
1044|083|S|tell your doctor or pharmacist promptly.||
1044|084|S|   People using this medication may have serious side effects.||
1044|085|S|However, you have been prescribed this drug because your doctor||
1044|086|S|has judged that the benefit to you is greater than the risk of||
1044|087|S|side effects. Careful monitoring by your doctor may decrease your||
1044|088|S|risk.||
1044|089|S|   This medication decreases bone marrow function, an effect that||
1044|090|S|may lead to a low number of blood cells such as red cells, white||
1044|091|S|cells, and platelets. This effect can cause anemia, decrease your||
1044|092|S|body's ability to fight an infection, or cause easy||
1044|093|S|bruising/bleeding. Tell your doctor right away if you develop any||
1044|094|S|of the following serious symptoms: unusual tiredness, pale skin,||
1044|095|S|signs of infection (such as sore throat that doesn't go away,||
1044|096|S|fever, chills), easy bruising/bleeding (such as bloody/black||
1044|097|S|stool).||
1044|098|S|   Nilotinib sometimes causes side effects due to the rapid||
1044|099|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1044|100|S|risk, your doctor may add a medication and tell you to drink||
1044|101|S|plenty of fluids. Tell your doctor right away if you have||
1044|102|S|symptoms such as: low back/side pain (flank pain), signs of||
1044|103|S|kidney problems (such as painful urination, pink/bloody urine,||
1044|104|S|change in the amount of urine), muscle spasms/weakness.||
1044|105|S|   Tell your doctor right away if you have any serious side||
1044|106|S|effects, including: severe stomach/abdominal pain, toe/joint||
1044|107|S|pain, swelling hands/ankles/feet, unusual/rapid weight gain,||
1044|108|S|symptoms of high blood sugar (such as increased||
1044|109|S|thirst/urination), signs of liver disease (such as||
1044|110|S|nausea/vomiting that doesn't stop, loss of appetite,||
1044|111|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1044|112|S|   Get medical help right away if you have any very serious side||
1044|113|S|effects, including: fast/pounding/irregular heartbeat, severe||
1044|114|S|dizziness, fainting, seizures, signs of a heart attack (such as||
1044|115|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
1044|116|S|signs of a stroke (such as weakness on one side of the body,||
1044|117|S|trouble speaking, sudden vision changes, confusion), signs of||
1044|118|S|bleeding in the brain (such as sudden severe headache, sudden||
1044|119|S|vision changes, confusion, loss of consciousness), signs of blood||
1044|120|S|circulation disease (such as numbness/pain in the legs, leg pain||
1044|121|S|with physical activity, decrease in walking distance).||
1044|122|S|   A very serious allergic reaction to this drug is rare.||
1044|123|S|However, get medical help right away if you notice any symptoms||
1044|124|S|of a serious allergic reaction, including: rash, itching/swelling||
1044|125|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1044|126|S|breathing.||
1044|127|S|   This is not a complete list of possible side effects. If you||
1044|128|S|notice other effects not listed above, contact your doctor or||
1044|129|S|pharmacist.||
1044|130|S|   In the US -||
1044|131|S|   Call your doctor for medical advice about side effects. You||
1044|132|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1044|133|S|www.fda.gov/medwatch.||
1044|134|S|   In Canada - Call your doctor for medical advice about side||
1044|135|S|effects. You may report side effects to Health Canada at||
1044|136|S|1-866-234-2345.||
1044|137|B|||
1044|138|P|PRECAUTIONS:  Before taking nilotinib, tell your doctor or||
1044|139|P|pharmacist if you are allergic to it; or if you have any other||
1044|140|P|allergies. This product may contain inactive ingredients, which||
1044|141|P|can cause allergic reactions or other problems. Talk to your||
1044|142|P|pharmacist for more details.||
1044|143|P|   Before using this medication, tell your doctor or pharmacist||
1044|144|P|your medical history, especially of: liver disease, pancreatitis,||
1044|145|P|heart disease (such as coronary artery disease, chest pain, heart||
1044|146|P|attack), high blood pressure, high cholesterol, diabetes, stroke||
1044|147|P|(including "mini-strokes" or transient ischemic attacks), blood||
1044|148|P|circulation disease (peripheral arterial disease), blood vessel||
1044|149|P|disease (hardening of the arteries/atherosclerosis), stomach||
1044|150|P|surgery (such as gastrectomy), lactose/galactose intolerance.||
1044|151|P|   Nilotinib may cause a condition that affects the heart rhythm||
1044|152|P|(QT prolongation). QT prolongation can rarely cause serious||
1044|153|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1044|154|P|as severe dizziness, fainting) that need medical attention right||
1044|155|P|away.||
1044|156|P|   The risk of QT prolongation may be increased if you have||
1044|157|P|certain medical conditions or are taking other drugs that may||
1044|158|P|cause QT prolongation. Before using nilotinib, tell your doctor||
1044|159|P|or pharmacist of all the drugs you take and if you have any of||
1044|160|P|the following conditions: certain heart problems (heart failure,||
1044|161|P|slow heartbeat, QT prolongation in the EKG), family history of||
1044|162|P|certain heart problems (QT prolongation in the EKG, sudden||
1044|163|P|cardiac death).||
1044|164|P|   Low levels of potassium or magnesium in the blood may also||
1044|165|P|increase your risk of QT prolongation. This risk may increase if||
1044|166|P|you use certain drugs (such as diuretics/"water pills") or if you||
1044|167|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1044|168|P|Talk to your doctor about using nilotinib safely.||
1044|169|P|   Before having surgery, tell your doctor or dentist about all||
1044|170|P|the products you use (including prescription drugs,||
1044|171|P|nonprescription drugs, and herbal products).||
1044|172|P|   Nilotinib can make you more likely to get infections or may||
1044|173|P|make current infections worse. Stay away from anyone who has an||
1044|174|P|infection that may easily spread (such as chickenpox, COVID-19,||
1044|175|P|measles, flu). Talk to your doctor if you have been exposed to an||
1044|176|P|infection or for more details.||
1044|177|P|   Tell your health care professional that you are using||
1044|178|P|nilotinib before having any immunizations/vaccinations. Avoid||
1044|179|P|contact with people who have recently received live vaccines||
1044|180|P|(such as flu vaccine inhaled through the nose).||
1044|181|P|   To lower the chance of getting cut, bruised, or injured, use||
1044|182|P|caution with sharp objects like razors and nail cutters, and||
1044|183|P|avoid activities such as contact sports.||
1044|184|P|   Children may be more sensitive to the side effects of this||
1044|185|P|drug, especially liver disease and slowed growth and development.||
1044|186|P|Consult the doctor or pharmacist for more details. See the doctor||
1044|187|P|regularly so your child's liver function, height, weight, and||
1044|188|P|development can be checked.||
1044|189|P|   Older adults may be more sensitive to the side effects of this||
1044|190|P|drug, especially QT prolongation (see above).||
1044|191|P|   Since this drug can be absorbed through the skin and lungs and||
1044|192|P|may harm an unborn baby, women who are pregnant or who may become||
1044|193|P|pregnant should not handle this medication or breathe the dust||
1044|194|P|from the capsules.||
1044|195|P|   Tell your doctor if you are pregnant or plan to become||
1044|196|P|pregnant. You should not become pregnant while using nilotinib.||
1044|197|P|Nilotinib may harm an unborn baby. Your doctor should order a||
1044|198|P|pregnancy test before you start this medication. Ask about||
1044|199|P|reliable forms of birth control while using this medication and||
1044|200|P|for 14 days after the last dose. If you become pregnant, talk to||
1044|201|P|your doctor right away about the risks and benefits of this||
1044|202|P|medication.||
1044|203|P|   It is unknown if this drug passes into breast milk. Because of||
1044|204|P|the possible risk to the infant, breastfeeding is not recommended||
1044|205|P|while using this drug and for 14 days after the last dose.||
1044|206|P|Consult your doctor before breastfeeding.||
1044|207|B|||
1044|208|I|DRUG INTERACTIONS:  See also How to Use section.||
1044|209|I|   Drug interactions may change how your medications work or||
1044|210|I|increase your risk for serious side effects. This document does||
1044|211|I|not contain all possible drug interactions. Keep a list of all||
1044|212|I|the products you use (including prescription/nonprescription||
1044|213|I|drugs and herbal products) and share it with your doctor and||
1044|214|I|pharmacist. Do not start, stop, or change the dosage of any||
1044|215|I|medicines without your doctor's approval.||
1044|216|I|   Some products that may interact with this drug are:||
1044|217|I|elacestrant, flibanserin.||
1044|218|I|   Other medications can affect the removal of nilotinib from||
1044|219|I|your body, which may affect how nilotinib works. Examples include||
1044|220|I|azole antifungals (such as itraconazole, ketoconazole), macrolide||
1044|221|I|antibiotics (such as clarithromycin), rifamycins (such as||
1044|222|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
1044|223|I|seizures (such as carbamazepine, phenytoin), among others.||
1044|224|I|   Many drugs besides nilotinib may affect the heart rhythm (QT||
1044|225|I|prolongation), such as amiodarone, dofetilide, pimozide,||
1044|226|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
1044|227|I|erythromycin), among others.||
1044|228|B|||
1044|229|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1044|230|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1044|231|O|poison control center right away. US residents can call||
1044|232|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1044|233|B|||
1044|234|N|NOTES:  Do not share this medication with others.||
1044|235|N|   Lab and/or medical tests (such as growth and development||
1044|236|N|checks for children, complete blood count, EKG, blood mineral||
1044|237|N|levels, liver function, lipase levels, uric acid level,||
1044|238|N|cholesterol level, blood sugar) should be done while you are||
1044|239|N|taking this medication. Keep all medical and lab appointments.||
1044|240|N|Consult your doctor for more details.||
1044|241|B|||
1044|242|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1044|243|D|next dose at the regular time. Do not double the dose to catch||
1044|244|D|up.||
1044|245|B|||
1044|246|R|STORAGE:  Store at room temperature away from light and moisture.||
1044|247|R|Do not store in the bathroom. Keep all medications away from||
1044|248|R|children and pets.||
1044|249|R|   Do not flush medications down the toilet or pour them into a||
1044|250|R|drain unless instructed to do so. Properly discard this product||
1044|251|R|when it is expired or no longer needed. Consult your pharmacist||
1044|252|R|or local waste disposal company.||
1044|253|B|||
1044|254|M|MEDICAL ALERT:  Your condition can cause complications in a||
1044|255|M|medical emergency. For information about enrolling in MedicAlert,||
1044|256|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1044|257|B|||
1044|258|A|Information last revised September 2025.||
1044|259|A|Copyright(c) 2025 First Databank, Inc.||
1044|260|B|||
1045|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1045|002|Z|does NOT have all possible information about this product. This||
1045|003|Z|information does not assure that this product is safe, effective,||
1045|004|Z|or appropriate for you. This information is not individual||
1045|005|Z|medical advice and does not substitute for the advice of your||
1045|006|Z|health care professional. Always ask your health care||
1045|007|Z|professional for complete information about this product and your||
1045|008|Z|specific health needs.||
1045|009|B|||
1045|010|T|VITAMIN B12/FOLIC ACID/VITAMIN B6/OMEGA-3 FATTY ACIDS - ORAL||
1045|011|B|||
1045|012|C|COMMON BRAND NAME(S): Animi-3||
1045|013|B|||
1045|014|U|USES:  This product contains vitamin B12, folic acid, vitamin B6,||
1045|015|U|and omega-3 fatty acids. It is used to treat or prevent a lack of||
1045|016|U|these nutrients during pregnancy or due to poor diet or certain||
1045|017|U|illnesses. Vitamins are important building blocks of the body and||
1045|018|U|help keep you in good health. Women who are or may become||
1045|019|U|pregnant should maintain adequate levels of folic acid through||
1045|020|U|either diet or supplements to prevent spinal cord birth defects.||
1045|021|U|Omega-3 fatty acids are thought to help reduce the risk of heart||
1045|022|U|disease and also to promote healthy skin.||
1045|023|U|   Some supplement products have been found to contain possibly||
1045|024|U|harmful impurities/additives. Check with your pharmacist for more||
1045|025|U|details about the brand you use.||
1045|026|U|   The FDA has not reviewed this product for safety or||
1045|027|U|effectiveness. Consult your doctor or pharmacist for more||
1045|028|U|details.||
1045|029|B|||
1045|030|H|HOW TO USE:  Take this medication by mouth with or without food||
1045|031|H|as directed by your doctor, usually once daily. If stomach upset||
1045|032|H|occurs, it may help to take this product with food.||
1045|033|H|   Use this medication regularly in order to get the most benefit||
1045|034|H|from it. To help you remember, use it at the same time each day.||
1045|035|H|The dosage is based on your medical condition and response to||
1045|036|H|treatment.||
1045|037|B|||
1045|038|S|SIDE EFFECTS:  Nausea, stomach upset, diarrhea, or flushing may||
1045|039|S|occur. If any of these effects last or get worse, tell your||
1045|040|S|doctor or pharmacist promptly.||
1045|041|S|   Remember that this medication has been prescribed because your||
1045|042|S|doctor has judged that the benefit to you is greater than the||
1045|043|S|risk of side effects. Many people using this medication do not||
1045|044|S|have serious side effects.||
1045|045|S|   Tell your doctor right away if you have any serious side||
1045|046|S|effects, including: easy bruising/bleeding.||
1045|047|S|   A very serious allergic reaction to this drug is rare.||
1045|048|S|However, get medical help right away if you notice any symptoms||
1045|049|S|of a serious allergic reaction, including: rash, itching/swelling||
1045|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1045|051|S|breathing.||
1045|052|S|   This is not a complete list of possible side effects. If you||
1045|053|S|notice other effects not listed above, contact your doctor or||
1045|054|S|pharmacist.||
1045|055|S|   In the US -||
1045|056|S|   Call your doctor for medical advice about side effects. You||
1045|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1045|058|S|www.fda.gov/medwatch.||
1045|059|S|   In Canada - Call your doctor for medical advice about side||
1045|060|S|effects. You may report side effects to Health Canada at||
1045|061|S|1-866-234-2345.||
1045|062|B|||
1045|063|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1045|064|P|pharmacist if you are allergic to any of its ingredients; or to||
1045|065|P|fish or soy products; or if you have any other allergies. This||
1045|066|P|product may contain inactive ingredients, which can cause||
1045|067|P|allergic reactions or other problems. Talk to your pharmacist for||
1045|068|P|more details.||
1045|069|P|   Before taking this medication, tell your doctor or pharmacist||
1045|070|P|your medical history, especially of: certain blood disorders||
1045|071|P|(such as pernicious anemia, other anemias).||
1045|072|P|   Before having surgery, tell your doctor or dentist about all||
1045|073|P|the products you use (including prescription drugs,||
1045|074|P|nonprescription drugs, and herbal products).||
1045|075|P|   During pregnancy, this medication should be used only when||
1045|076|P|clearly needed. Discuss the risks and benefits with your doctor.||
1045|077|P|   This medication passes into breast milk. Consult your doctor||
1045|078|P|before breastfeeding.||
1045|079|B|||
1045|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1045|081|I|medications work or increase your risk for serious side effects.||
1045|082|I|This document does not contain all possible drug interactions.||
1045|083|I|Keep a list of all the products you use (including||
1045|084|I|prescription/nonprescription drugs and herbal products) and share||
1045|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
1045|086|I|the dosage of any medicines without your doctor's approval.||
1045|087|I|   This product may interfere with certain lab tests (such as||
1045|088|I|intrinsic factor antibodies, certain urobilinogen tests),||
1045|089|I|possibly causing false test results. Make sure lab personnel and||
1045|090|I|all your doctors know you use this product.||
1045|091|B|||
1045|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1045|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1045|094|O|poison control center right away. US residents can call||
1045|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1045|096|B|||
1045|097|N|NOTES:  Do not share this medication with others.||
1045|098|N|   Lab and/or medical tests (such as complete blood count,||
1045|099|N|vitamin B12 levels in the blood) may be done while you are taking||
1045|100|N|this medication. Keep all medical and lab appointments. Consult||
1045|101|N|your doctor for more details.||
1045|102|N|   Remember that it is best to get your vitamins and minerals||
1045|103|N|from healthy foods. Maintain a well-balanced diet, and follow any||
1045|104|N|dietary guidelines as directed by your doctor. B vitamins,||
1045|105|N|including folic acid, are naturally found in leafy greens, other||
1045|106|N|vegetables, and citrus fruits. Folic acid is also found in||
1045|107|N|enriched grains such as bread, pasta, and cereal.||
1045|108|B|||
1045|109|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1045|110|D|remember. If it is near the time of the next dose, skip the||
1045|111|D|missed dose. Take your next dose at the regular time. Do not||
1045|112|D|double the dose to catch up.||
1045|113|B|||
1045|114|R|STORAGE:  Store at room temperature away from light and moisture.||
1045|115|R|Do not store in the bathroom. Keep all medications away from||
1045|116|R|children and pets.||
1045|117|R|   Do not flush medications down the toilet or pour them into a||
1045|118|R|drain unless instructed to do so. Properly discard this product||
1045|119|R|when it is expired or no longer needed. Consult your pharmacist||
1045|120|R|or local waste disposal company.||
1045|121|B|||
1045|122|A|Information last revised October 2025.||
1045|123|A|Copyright(c) 2025 First Databank, Inc.||
1045|124|B|||
1046|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1046|002|Z|does NOT have all possible information about this product. This||
1046|003|Z|information does not assure that this product is safe, effective,||
1046|004|Z|or appropriate for you. This information is not individual||
1046|005|Z|medical advice and does not substitute for the advice of your||
1046|006|Z|health care professional. Always ask your health care||
1046|007|Z|professional for complete information about this product and your||
1046|008|Z|specific health needs.||
1046|009|B|||
1046|010|T|FLOXURIDINE - INJECTION||
1046|011|F|(flox-YOUR-eh-deen)||
1046|012|B|||
1046|013|C|COMMON BRAND NAME(S): FUDR||
1046|014|B|||
1046|015|U|USES:  Floxuridine is used to treat certain types of||
1046|016|U|stomach/intestinal cancer that have spread to the liver. It is a||
1046|017|U|chemotherapy drug that is used to slow or stop cancer cell||
1046|018|U|growth.||
1046|019|B|||
1046|020|H|HOW TO USE:  This medication is given by injection into an artery||
1046|021|H|using a continuous infusion pump. It is given through a catheter||
1046|022|H|placed inside the artery that supplies blood to the tumor. This||
1046|023|H|method directs the medication to the tumor so that it can have a||
1046|024|H|stronger effect on the tumor with less risk of serious side||
1046|025|H|effects in the rest of the body. When starting the first course||
1046|026|H|of treatment with this medication, you should be in a hospital||
1046|027|H|where you can be monitored for possible serious side effects.||
1046|028|H|   This medication will be prepared and mixed for you by a health||
1046|029|H|care professional. The dosage is based on your medical condition,||
1046|030|H|weight, and response to treatment.||
1046|031|H|   This medication should be used as long as you continue to||
1046|032|H|benefit from the treatment. When serious side effects appear,||
1046|033|H|your doctor will stop treatment with this medication. After the||
1046|034|H|side effects have lessened, treatment will resume.||
1046|035|B|||
1046|036|S|SIDE EFFECTS:  Nausea, vomiting, mild diarrhea, loss of appetite,||
1046|037|S|tiredness, redness at the injection site, or dry skin may occur.||
1046|038|S|Nausea and vomiting can be severe. In some cases, your doctor may||
1046|039|S|prescribe medication to prevent or relieve nausea and vomiting.||
1046|040|S|Eating several small meals or limiting activity may help lessen||
1046|041|S|some of these effects. If any of these effects last or get worse,||
1046|042|S|tell your doctor or pharmacist promptly.||
1046|043|S|   Temporary hair loss may occur. Normal hair growth should||
1046|044|S|return after treatment has ended.||
1046|045|S|   People using this medication may have serious side effects.||
1046|046|S|However, you have been prescribed this drug because your doctor||
1046|047|S|has judged that the benefit to you is greater than the risk of||
1046|048|S|side effects. Careful monitoring by your doctor may decrease your||
1046|049|S|risk.||
1046|050|S|   This medication can lower the body's ability to fight an||
1046|051|S|infection. Tell your doctor right away if you develop any signs||
1046|052|S|of an infection (such as sore throat that doesn't go away, fever,||
1046|053|S|chills).||
1046|054|S|   Tell your doctor right away if you have any serious side||
1046|055|S|effects, including: vomiting/diarrhea that is severe or doesn't||
1046|056|S|stop, mouth sores, sore throat, painful/difficult swallowing,||
1046|057|S|easy or unusual bruising/bleeding, black stools, blood/mucus in||
1046|058|S|the stools, vomit that looks like coffee grounds, cramps/pain in||
1046|059|S|the stomach/abdomen, yellowing eyes/skin, dark urine, weakness,||
1046|060|S|weight loss, skin problems (such as peeling/darkening of the||
1046|061|S|skin), muscle/joint pain.||
1046|062|S|   Get medical help right away if you have any very serious side||
1046|063|S|effects, including: chest/jaw/left arm pain,||
1046|064|S|warmth/swelling/pain/leaking at the injection site,||
1046|065|S|pain/swelling/redness/weakness of the arms or legs, calf||
1046|066|S|pain/swelling that is warm to the touch, shortness of breath,||
1046|067|S|coughing up blood, sudden vision changes, weakness on one side of||
1046|068|S|the body, severe clumsiness/trouble walking, trouble speaking,||
1046|069|S|confusion, severe headache.||
1046|070|S|   A very serious allergic reaction to this drug is rare.||
1046|071|S|However, get medical help right away if you notice any symptoms||
1046|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1046|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1046|074|S|breathing.||
1046|075|S|   This is not a complete list of possible side effects. If you||
1046|076|S|notice other effects not listed above, contact your doctor or||
1046|077|S|pharmacist.||
1046|078|S|   In the US -||
1046|079|S|   Call your doctor for medical advice about side effects. You||
1046|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1046|081|S|www.fda.gov/medwatch.||
1046|082|S|   In Canada - Call your doctor for medical advice about side||
1046|083|S|effects. You may report side effects to Health Canada at||
1046|084|S|1-866-234-2345.||
1046|085|B|||
1046|086|P|PRECAUTIONS:  Before using floxuridine, tell your doctor or||
1046|087|P|pharmacist if you are allergic to it; or to fluorouracil; or if||
1046|088|P|you have any other allergies. This product may contain inactive||
1046|089|P|ingredients, which can cause allergic reactions or other||
1046|090|P|problems. Talk to your pharmacist for more details.||
1046|091|P|   Before using this medication, tell your doctor or pharmacist||
1046|092|P|your medical history, especially of: poor nutrition, decreased||
1046|093|P|bone marrow function/blood cell disorders (such as anemia,||
1046|094|P|leukopenia, thrombocytopenia), a serious infection, liver||
1046|095|P|problems, kidney problems, past high-dose radiation treatment of||
1046|096|P|the pelvis.||
1046|097|P|   Tell your health care professional that you are using||
1046|098|P|floxuridine before having any immunizations/vaccinations. Avoid||
1046|099|P|contact with people who have recently received live vaccines||
1046|100|P|(such as flu vaccine inhaled through the nose).||
1046|101|P|   Floxuridine can make you more likely to get infections or may||
1046|102|P|make current infections worse. Stay away from anyone who has an||
1046|103|P|infection that may easily spread (such as chickenpox, COVID-19,||
1046|104|P|measles, flu). Talk to your doctor if you have been exposed to an||
1046|105|P|infection or for more details.||
1046|106|P|   To lower the chance of getting cut, bruised, or injured, use||
1046|107|P|caution with sharp objects like safety razors and nail cutters,||
1046|108|P|and avoid activities such as contact sports.||
1046|109|P|   This medication may make you more sensitive to the sun. Limit||
1046|110|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1046|111|P|sunscreen and wear protective clothing when outdoors. Tell your||
1046|112|P|doctor right away if you get sunburned or have skin||
1046|113|P|blisters/redness.||
1046|114|P|   Before having surgery, tell your doctor or dentist about all||
1046|115|P|the products you use (including prescription drugs,||
1046|116|P|nonprescription drugs, and herbal products).||
1046|117|P|   Tell your doctor if you are pregnant or plan to become||
1046|118|P|pregnant. You should not become pregnant while using floxuridine.||
1046|119|P|Floxuridine may harm an unborn baby. Ask about reliable forms of||
1046|120|P|birth control while using this medication. If you become||
1046|121|P|pregnant, talk to your doctor right away about the risks and||
1046|122|P|benefits of this medication.||
1046|123|P|   It is unknown if this drug passes into breast milk. Because of||
1046|124|P|the possible risk to the infant, breastfeeding is not recommended||
1046|125|P|while using this drug. Consult your doctor before breastfeeding.||
1046|126|B|||
1046|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1046|128|I|medications work or increase your risk for serious side effects.||
1046|129|I|This document does not contain all possible drug interactions.||
1046|130|I|Keep a list of all the products you use (including||
1046|131|I|prescription/nonprescription drugs and herbal products) and share||
1046|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
1046|133|I|the dosage of any medicines without your doctor's approval.||
1046|134|I|   Some products that may interact with this drug include: drugs||
1046|135|I|that may decrease bone marrow function (such as azathioprine,||
1046|136|I|trimethoprim/sulfamethoxazole), past or present use of||
1046|137|I|alkylating-type cancer drugs (such as melphalan).||
1046|138|I|   Floxuridine is very similar to fluorouracil. Do not use||
1046|139|I|medications containing fluorouracil while using floxuridine.||
1046|140|B|||
1046|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1046|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1046|143|O|poison control center right away. US residents can call||
1046|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1046|145|B|||
1046|146|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
1046|147|N|should be done while you are using this medication. Keep all||
1046|148|N|medical and lab appointments. Consult your doctor for more||
1046|149|N|details.||
1046|150|B|||
1046|151|D|MISSED DOSE:  The drug is given continuously as an infusion. If||
1046|152|D|your infusion is interrupted, contact your doctor or pharmacist||
1046|153|D|right away.||
1046|154|B|||
1046|155|R|STORAGE:  Consult the product instructions and your pharmacist||
1046|156|R|for storage details. Keep all medications away from children and||
1046|157|R|pets.||
1046|158|R|   Do not flush medications down the toilet or pour them into a||
1046|159|R|drain unless instructed to do so. Properly discard this product||
1046|160|R|when it is expired or no longer needed. Consult your pharmacist||
1046|161|R|or local waste disposal company.||
1046|162|B|||
1046|163|M|MEDICAL ALERT:  Your condition can cause complications in a||
1046|164|M|medical emergency. For information about enrolling in MedicAlert,||
1046|165|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1046|166|B|||
1046|167|A|Information last revised April 2025.||
1046|168|A|Copyright(c) 2025 First Databank, Inc.||
1046|169|B|||
1047|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1047|002|Z|does NOT have all possible information about this product. This||
1047|003|Z|information does not assure that this product is safe, effective,||
1047|004|Z|or appropriate for you. This information is not individual||
1047|005|Z|medical advice and does not substitute for the advice of your||
1047|006|Z|health care professional. Always ask your health care||
1047|007|Z|professional for complete information about this product and your||
1047|008|Z|specific health needs.||
1047|009|B|||
1047|010|T|VENLAFAXINE SUSTAINED-RELEASE - ORAL||
1047|011|F|(ven-luh-FAX-een)||
1047|012|B|||
1047|013|C|COMMON BRAND NAME(S): Effexor XR||
1047|014|B|||
1047|015|W|WARNING:  Antidepressant medications are used to treat a variety||
1047|016|W|of conditions, including depression and other mental/mood||
1047|017|W|disorders. These medications can help prevent suicidal||
1047|018|W|thoughts/attempts and provide other important benefits. However,||
1047|019|W|a small number of people (especially people younger than 25) who||
1047|020|W|take antidepressants for any condition may experience worsening||
1047|021|W|depression, other mental/mood symptoms, or suicidal||
1047|022|W|thoughts/attempts. It is very important to talk with the doctor||
1047|023|W|about the risks and benefits of antidepressant medication||
1047|024|W|(especially for people younger than 25), even if treatment is not||
1047|025|W|for a mental/mood condition.||
1047|026|W|   Tell the doctor right away if you notice worsening||
1047|027|W|depression/other psychiatric conditions, unusual behavior changes||
1047|028|W|(including possible suicidal thoughts/attempts), or other||
1047|029|W|mental/mood changes (including new/worsening anxiety, panic||
1047|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1047|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
1047|032|W|especially watchful for these symptoms when a new antidepressant||
1047|033|W|is started or when the dose is changed.||
1047|034|B|||
1047|035|U|USES:  This medication is used to treat certain mental/mood||
1047|036|U|disorders (such as depression, anxiety, panic attacks, and social||
1047|037|U|anxiety disorder). Venlafaxine belongs to a class of drugs known||
1047|038|U|as serotonin-norepinephrine reuptake inhibitors (SNRIs). It works||
1047|039|U|by helping to restore the balance of certain natural substances||
1047|040|U|(serotonin and norepinephrine) in the brain.||
1047|041|B|||
1047|042|V|OTHER USES:  This section contains uses of this drug that are not||
1047|043|V|listed in the approved professional labeling for the drug but||
1047|044|V|that may be prescribed by your health care professional. Use this||
1047|045|V|drug for a condition that is listed in this section only if it||
1047|046|V|has been so prescribed by your health care professional.||
1047|047|V|   This drug may also be used for hot flashes that occur with||
1047|048|V|menopause. It may also be used for nerve pain.||
1047|049|B|||
1047|050|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1047|051|H|Patient Information Leaflet provided by your pharmacist before||
1047|052|H|you start using venlafaxine and each time you get a refill. If||
1047|053|H|you have any questions, ask your doctor or pharmacist.||
1047|054|H|   Take this medication by mouth as directed by your doctor,||
1047|055|H|usually once daily with food, either in the morning or evening.||
1047|056|H|   Do not crush, chew, or dissolve this medication. Doing so can||
1047|057|H|release all of the drug at once, increasing the risk of side||
1047|058|H|effects. Swallow whole without crushing or chewing.||
1047|059|H|   If you are taking the capsules, swallow them whole. If you||
1047|060|H|have trouble swallowing the capsules whole, you may open the||
1047|061|H|capsule and sprinkle the contents onto a spoonful of applesauce.||
1047|062|H|Swallow all of the mixture right away without chewing. Drink a||
1047|063|H|glass of water after each dose.||
1047|064|H|   The dosage is based on your medical condition and response to||
1047|065|H|treatment. To reduce your risk of side effects, your doctor may||
1047|066|H|direct you to start this medication at a low dose and gradually||
1047|067|H|increase your dose. Follow your doctor's instructions carefully.||
1047|068|H|Take this medication regularly to get the most benefit from it.||
1047|069|H|To help you remember, take it at the same time each day.||
1047|070|H|   Keep taking this medication even if you feel well. Do not stop||
1047|071|H|taking this medication without consulting your doctor. Some||
1047|072|H|conditions may become worse when this drug is suddenly stopped.||
1047|073|H|Also, you may experience symptoms such as confusion, mood swings,||
1047|074|H|blurred vision, headache, tiredness, sleep changes, and brief||
1047|075|H|feelings similar to electric shock. Your dose may need to be||
1047|076|H|gradually decreased to reduce side effects. Report any new or||
1047|077|H|worsening symptoms right away.||
1047|078|H|   It may take several weeks to feel the benefit of this||
1047|079|H|medication. Tell your doctor if your condition lasts or gets||
1047|080|H|worse.||
1047|081|B|||
1047|082|S|SIDE EFFECTS:  See also Warning section.||
1047|083|S|   Nausea, drowsiness, dizziness, dry mouth, constipation, loss||
1047|084|S|of appetite, blurred vision, nervousness, trouble sleeping,||
1047|085|S|unusual sweating, or yawning may occur. If any of these effects||
1047|086|S|last or get worse, tell your doctor promptly.||
1047|087|S|   Remember that this medication has been prescribed because your||
1047|088|S|doctor has judged that the benefit to you is greater than the||
1047|089|S|risk of side effects. Many people using this medication do not||
1047|090|S|have serious side effects.||
1047|091|S|   This medication may raise your blood pressure. Check your||
1047|092|S|blood pressure regularly and tell your doctor if the results are||
1047|093|S|high.||
1047|094|S|   Tell your doctor right away if you have any serious side||
1047|095|S|effects, including: easy bleeding/bruising, decreased interest in||
1047|096|S|sex, changes in sexual ability, muscle cramps/weakness, shaking||
1047|097|S|(tremor).||
1047|098|S|   Get medical help right away if you have any very serious side||
1047|099|S|effects, including: cough that doesn't go away, shortness of||
1047|100|S|breath, chest pain, severe/pounding headache, black stools, vomit||
1047|101|S|that looks like coffee grounds, eye pain/swelling/redness,||
1047|102|S|widened pupils, vision changes (such as seeing rainbows around||
1047|103|S|lights at night), seizure.||
1047|104|S|   This medication may increase serotonin and rarely cause a very||
1047|105|S|serious condition called serotonin syndrome/toxicity. The risk||
1047|106|S|increases if you are also taking other drugs that increase||
1047|107|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1047|108|S|take (see Drug Interactions section). Get medical help right away||
1047|109|S|if you develop some of the following symptoms: fast heartbeat,||
1047|110|S|hallucinations, loss of coordination, severe dizziness, severe||
1047|111|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1047|112|S|unusual agitation/restlessness.||
1047|113|S|   A very serious allergic reaction to this drug is rare.||
1047|114|S|However, get medical help right away if you notice any symptoms||
1047|115|S|of a serious allergic reaction, including: rash, itching/swelling||
1047|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1047|117|S|breathing.||
1047|118|S|   This is not a complete list of possible side effects. If you||
1047|119|S|notice other effects not listed above, contact your doctor or||
1047|120|S|pharmacist.||
1047|121|S|   In the US -||
1047|122|S|   Call your doctor for medical advice about side effects. You||
1047|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1047|124|S|www.fda.gov/medwatch.||
1047|125|S|   In Canada - Call your doctor for medical advice about side||
1047|126|S|effects. You may report side effects to Health Canada at||
1047|127|S|1-866-234-2345.||
1047|128|B|||
1047|129|P|PRECAUTIONS:  Before taking venlafaxine, tell your doctor or||
1047|130|P|pharmacist if you are allergic to it; or to desvenlafaxine; or if||
1047|131|P|you have any other allergies. This product may contain inactive||
1047|132|P|ingredients, which can cause allergic reactions or other||
1047|133|P|problems. Talk to your pharmacist for more details.||
1047|134|P|   Before using this medication, tell your doctor or pharmacist||
1047|135|P|your medical history, especially of: bleeding problems, personal||
1047|136|P|or family history of glaucoma (angle-closure type), high blood||
1047|137|P|pressure, heart problems (such as heart failure, previous heart||
1047|138|P|attack), high cholesterol, kidney disease, liver disease, seizure||
1047|139|P|disorder, thyroid disease.||
1047|140|P|   This drug may make you dizzy or drowsy or blur your vision.||
1047|141|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1047|142|P|drowsy. Do not drive, use machinery, or do anything that needs||
1047|143|P|alertness or clear vision until you can do it safely. Avoid||
1047|144|P|alcoholic beverages. Talk to your doctor if you are using||
1047|145|P|marijuana (cannabis).||
1047|146|P|   Before having surgery, tell your doctor or dentist about all||
1047|147|P|the products you use (including prescription drugs,||
1047|148|P|nonprescription drugs, and herbal products).||
1047|149|P|   Older adults may be more sensitive to the side effects of this||
1047|150|P|drug, especially dizziness when standing. Older adults may also||
1047|151|P|be more likely to develop a type of salt imbalance||
1047|152|P|(hyponatremia), especially if they are taking "water pills"||
1047|153|P|(diuretics). Dizziness and salt imbalance can increase the risk||
1047|154|P|of falling. Older adults may also be at greater risk for bleeding||
1047|155|P|while using this drug.||
1047|156|P|   Children may be more sensitive to the side effects of the||
1047|157|P|drug, especially loss of appetite and weight loss. Monitor weight||
1047|158|P|and height in children who are taking this drug.||
1047|159|P|   During pregnancy, this medication should be used only when||
1047|160|P|clearly needed. It may harm an unborn baby. Also, babies born to||
1047|161|P|mothers who have used this drug during the last 3 months of||
1047|162|P|pregnancy may rarely develop withdrawal symptoms such as||
1047|163|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
1047|164|P|constant crying. If you notice any of these symptoms in your||
1047|165|P|newborn, tell the doctor promptly.||
1047|166|P|   Since untreated mental/mood problems (such as depression,||
1047|167|P|anxiety, panic attacks) can be a serious condition, do not stop||
1047|168|P|taking this medication unless directed by your doctor. If you are||
1047|169|P|planning pregnancy, become pregnant, or think you may be||
1047|170|P|pregnant, immediately discuss the benefits and risks of using||
1047|171|P|this medication during pregnancy with your doctor.||
1047|172|P|   This drug passes into breast milk and may have undesirable||
1047|173|P|effects on a nursing infant. Consult your doctor before||
1047|174|P|breastfeeding.||
1047|175|B|||
1047|176|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1047|177|I|medications work or increase your risk for serious side effects.||
1047|178|I|This document does not contain all possible drug interactions.||
1047|179|I|Keep a list of all the products you use (including||
1047|180|I|prescription/nonprescription drugs and herbal products) and share||
1047|181|I|it with your doctor and pharmacist. Do not start, stop, or change||
1047|182|I|the dosage of any medicines without your doctor's approval.||
1047|183|I|   Some products that may interact with this drug are: other||
1047|184|I|drugs that can cause bleeding/bruising (including antiplatelet||
1047|185|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
1047|186|I|"blood thinners" such as dabigatran/warfarin).||
1047|187|I|   Aspirin can increase the risk of bleeding when used with this||
1047|188|I|medication. However, if your doctor has told you to take low-dose||
1047|189|I|aspirin to prevent heart attack or stroke (usually 81-162||
1047|190|I|milligrams a day), you should keep taking the aspirin unless your||
1047|191|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1047|192|I|details.||
1047|193|I|   Taking MAO inhibitors with this medication may cause a serious||
1047|194|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1047|195|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1047|196|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1047|197|I|selegiline, tranylcypromine) during treatment with this||
1047|198|I|medication. Most MAO inhibitors should also not be taken for two||
1047|199|I|weeks before and at least 7 days after treatment with this||
1047|200|I|medication. Ask your doctor when to start or stop taking this||
1047|201|I|medication.||
1047|202|I|   The risk of serotonin syndrome/toxicity increases if you are||
1047|203|I|also taking other drugs that increase serotonin. Examples include||
1047|204|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1047|205|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1047|206|I|other SNRIs such as duloxetine/milnacipran), tryptophan, among||
1047|207|I|others. The risk of serotonin syndrome/toxicity may be more||
1047|208|I|likely when you start or increase the dose of these drugs.||
1047|209|I|   Tell your doctor or pharmacist if you are taking other||
1047|210|I|products that cause drowsiness such as opioid pain or cough||
1047|211|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1047|212|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1047|213|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1047|214|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1047|215|I|diphenhydramine).||
1047|216|I|   Check the labels on all your medicines (such as allergy or||
1047|217|I|cough-and-cold products) because they may contain ingredients||
1047|218|I|that cause drowsiness. Ask your pharmacist about using those||
1047|219|I|products safely.||
1047|220|I|   Venlafaxine is very similar to desvenlafaxine. Do not take||
1047|221|I|medications containing desvenlafaxine while using venlafaxine.||
1047|222|I|   This medication may interfere with certain lab tests||
1047|223|I|(including urine tests for amphetamines), possibly causing false||
1047|224|I|test results. Make sure lab personnel and all your doctors know||
1047|225|I|you use this drug.||
1047|226|B|||
1047|227|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1047|228|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1047|229|O|poison control center right away. US residents can call||
1047|230|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1047|231|O|Symptoms of overdose may include: severe drowsiness, seizures,||
1047|232|O|fast/irregular heartbeat.||
1047|233|B|||
1047|234|N|NOTES:  Do not share this medication with others.||
1047|235|N|   Lab and/or medical tests (such as blood pressure, cholesterol)||
1047|236|N|should be done while you are taking this medication. Keep all||
1047|237|N|medical and lab appointments. Consult your doctor for more||
1047|238|N|details.||
1047|239|B|||
1047|240|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1047|241|D|remember. If it is near the time of the next dose, skip the||
1047|242|D|missed dose. Take your next dose at the regular time. Do not||
1047|243|D|double the dose to catch up.||
1047|244|B|||
1047|245|R|STORAGE:  Store at room temperature away from light and moisture.||
1047|246|R|Do not store in the bathroom. Keep all medications away from||
1047|247|R|children and pets.||
1047|248|R|   Do not flush medications down the toilet or pour them into a||
1047|249|R|drain unless instructed to do so. Properly discard this product||
1047|250|R|when it is expired or no longer needed. Consult your pharmacist||
1047|251|R|or local waste disposal company.||
1047|252|B|||
1047|253|A|Information last revised May 2024.||
1047|254|A|Copyright(c) 2025 First Databank, Inc.||
1047|255|B|||
1048|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1048|002|Z|does NOT have all possible information about this product. This||
1048|003|Z|information does not assure that this product is safe, effective,||
1048|004|Z|or appropriate for you. This information is not individual||
1048|005|Z|medical advice and does not substitute for the advice of your||
1048|006|Z|health care professional. Always ask your health care||
1048|007|Z|professional for complete information about this product and your||
1048|008|Z|specific health needs.||
1048|009|B|||
1048|010|T|ISOSORBIDE MONONITRATE SUSTAINED-RELEASE - ORAL||
1048|011|F|(EYE-soe-SOR-bide MON-oh-NYE-trate)||
1048|012|B|||
1048|013|C|COMMON BRAND NAME(S): Imdur||
1048|014|B|||
1048|015|U|USES:  Isosorbide mononitrate is used to prevent chest pain||
1048|016|U|(angina) in patients with a certain heart condition (coronary||
1048|017|U|artery disease). This medication belongs to a class of drugs||
1048|018|U|known as nitrates. It works by relaxing and widening blood||
1048|019|U|vessels so blood can flow more easily to the heart.||
1048|020|U|   This medication will not relieve chest pain once it occurs.||
1048|021|U|Also, it is not intended to be taken just before physical||
1048|022|U|activities (such as exercise or sexual intercourse) to prevent||
1048|023|U|chest pain. Other medications may be prescribed by your doctor||
1048|024|U|for these conditions. Consult your doctor for more details.||
1048|025|B|||
1048|026|H|HOW TO USE:  Take this medication by mouth as directed by your||
1048|027|H|doctor, usually once daily when you wake up. Swallow this||
1048|028|H|medication whole with a half glass of water (4 ounces/120||
1048|029|H|milliliters) unless your doctor directs you otherwise. Do not||
1048|030|H|crush or chew this medication. Doing so can release all of the||
1048|031|H|drug at once, increasing the risk of side effects. Also, do not||
1048|032|H|split the tablets unless they have a score line and your doctor||
1048|033|H|or pharmacist tells you to do so. Swallow the whole or split||
1048|034|H|tablet without crushing or chewing.||
1048|035|H|   Use this medication regularly to get the most benefit from it.||
1048|036|H|To help you remember, take it at the same time each day. Do not||
1048|037|H|stop taking it without consulting your doctor. Some conditions||
1048|038|H|may become worse when the drug is suddenly stopped. Your dose may||
1048|039|H|need to be gradually decreased.||
1048|040|H|   Although unlikely, when this medication is used for a long||
1048|041|H|time, it may not work as well and may require different dosing.||
1048|042|H|Tell your doctor if this medication stops working well (for||
1048|043|H|example, you have more frequent or worsening chest pain).||
1048|044|B|||
1048|045|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, nausea, and||
1048|046|S|flushing may occur as your body adjusts to this medication. If||
1048|047|S|any of these effects last or get worse, tell your doctor or||
1048|048|S|pharmacist promptly.||
1048|049|S|   Headache is often a sign that this medication is working. Your||
1048|050|S|doctor may recommend treating headaches with an over-the-counter||
1048|051|S|pain reliever (such as acetaminophen, aspirin). If headaches||
1048|052|S|continue or become severe, tell your doctor promptly.||
1048|053|S|   To reduce the risk of dizziness and lightheadedness, get up||
1048|054|S|slowly when rising from a sitting or lying position.||
1048|055|S|   An empty tablet shell may appear in your stool. This effect is||
1048|056|S|harmless since your body has already absorbed the medication.||
1048|057|S|   Remember that this medication has been prescribed because your||
1048|058|S|doctor has judged that the benefit to you is greater than the||
1048|059|S|risk of side effects. Many people using this medication do not||
1048|060|S|have serious side effects.||
1048|061|S|   Tell your doctor right away if you have any serious side||
1048|062|S|effects, including: fainting, fast/irregular/pounding heartbeat.||
1048|063|S|   A very serious allergic reaction to this drug is rare.||
1048|064|S|However, get medical help right away if you notice any symptoms||
1048|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1048|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1048|067|S|breathing.||
1048|068|S|   This is not a complete list of possible side effects. If you||
1048|069|S|notice other effects not listed above, contact your doctor or||
1048|070|S|pharmacist.||
1048|071|S|   In the US -||
1048|072|S|   Call your doctor for medical advice about side effects. You||
1048|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1048|074|S|www.fda.gov/medwatch.||
1048|075|S|   In Canada - Call your doctor for medical advice about side||
1048|076|S|effects. You may report side effects to Health Canada at||
1048|077|S|1-866-234-2345.||
1048|078|B|||
1048|079|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1048|080|P|pharmacist if you are allergic to it; or to similar drugs (such||
1048|081|P|as isosorbide dinitrate, nitroglycerin); or if you have any other||
1048|082|P|allergies. This product may contain inactive ingredients, which||
1048|083|P|can cause allergic reactions or other problems. Talk to your||
1048|084|P|pharmacist for more details.||
1048|085|P|   Before using this medication, tell your doctor or pharmacist||
1048|086|P|your medical history, especially of: low blood pressure.||
1048|087|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1048|088|P|can make you more dizzy. Do not drive, use machinery, or do||
1048|089|P|anything that needs alertness until you can do it safely. Limit||
1048|090|P|alcoholic beverages. Talk to your doctor if you are using||
1048|091|P|marijuana (cannabis).||
1048|092|P|   Before having surgery, tell your doctor or dentist about all||
1048|093|P|the products you use (including prescription drugs,||
1048|094|P|nonprescription drugs, and herbal products).||
1048|095|P|   Older adults may be more sensitive to the side effects of this||
1048|096|P|medication, especially dizziness and lightheadedness, which could||
1048|097|P|increase the risk of falls.||
1048|098|P|   During pregnancy, this medication should be used only when||
1048|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
1048|100|P|   It is unknown if this medication passes into breast milk.||
1048|101|P|Consult your doctor before breastfeeding.||
1048|102|B|||
1048|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1048|104|I|medications work or increase your risk for serious side effects.||
1048|105|I|This document does not contain all possible drug interactions.||
1048|106|I|Keep a list of all the products you use (including||
1048|107|I|prescription/nonprescription drugs and herbal products) and share||
1048|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
1048|109|I|the dosage of any medicines without your doctor's approval.||
1048|110|I|   Some products that may interact with this drug include: drugs||
1048|111|I|to treat erectile dysfunction-ED or pulmonary hypertension (such||
1048|112|I|as sildenafil, tadalafil), riociguat, vericiguat.||
1048|113|I|   Some products have ingredients that could worsen your heart||
1048|114|I|failure. Tell your pharmacist what products you are using, and||
1048|115|I|ask how to use them safely (especially cough-and-cold products,||
1048|116|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1048|117|I|   Isosorbide mononitrate is very similar to isosorbide||
1048|118|I|dinitrate. Do not use medications containing isosorbide dinitrate||
1048|119|I|while using isosorbide mononitrate.||
1048|120|I|   This medication may interfere with certain lab tests (such as||
1048|121|I|cholesterol levels), possibly causing false test results. Make||
1048|122|I|sure lab personnel and all your doctors know you use this drug.||
1048|123|B|||
1048|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1048|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1048|126|O|poison control center right away. US residents can call||
1048|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1048|128|O|Symptoms of overdose may include: slow heartbeat, vision changes,||
1048|129|O|severe nausea/vomiting, sweating, cold/clammy skin, bluish||
1048|130|O|fingers/toes/lips.||
1048|131|B|||
1048|132|N|NOTES:  Do not share this medication with others.||
1048|133|N|   Lab and/or medical tests (such as blood pressure) should be||
1048|134|N|done while you are taking this medication. Keep all medical and||
1048|135|N|lab appointments. Consult your doctor for more details.||
1048|136|N|   Lifestyle changes such as dietary changes, exercise, and not||
1048|137|N|smoking may help this drug work better. Talk to your doctor or||
1048|138|N|pharmacist about lifestyle changes that might benefit you.||
1048|139|B|||
1048|140|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1048|141|D|remember. If it is more than 6 hours after the missed dose, skip||
1048|142|D|the missed dose. Take your next dose at the regular time. Do not||
1048|143|D|double the dose to catch up.||
1048|144|B|||
1048|145|R|STORAGE:  Store at room temperature away from light and moisture.||
1048|146|R|Do not store in the bathroom. Keep all medications away from||
1048|147|R|children and pets.||
1048|148|R|   Do not flush medications down the toilet or pour them into a||
1048|149|R|drain unless instructed to do so. Properly discard this product||
1048|150|R|when it is expired or no longer needed. Consult your pharmacist||
1048|151|R|or local waste disposal company.||
1048|152|B|||
1048|153|M|MEDICAL ALERT:  Your condition can cause complications in a||
1048|154|M|medical emergency. For information about enrolling in MedicAlert,||
1048|155|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1048|156|B|||
1048|157|A|Information last revised May 2024.||
1048|158|A|Copyright(c) 2025 First Databank, Inc.||
1048|159|B|||
1049|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1049|002|Z|does NOT have all possible information about this product. This||
1049|003|Z|information does not assure that this product is safe, effective,||
1049|004|Z|or appropriate for you. This information is not individual||
1049|005|Z|medical advice and does not substitute for the advice of your||
1049|006|Z|health care professional. Always ask your health care||
1049|007|Z|professional for complete information about this product and your||
1049|008|Z|specific health needs.||
1049|009|B|||
1049|010|T|FLURBIPROFEN - OPHTHALMIC||
1049|011|F|(flewr-BIH-pro-fen)||
1049|012|B|||
1049|013|C|COMMON BRAND NAME(S): Ocufen||
1049|014|B|||
1049|015|U|USES:  This medication is used before certain types of eye||
1049|016|U|surgery (such as cataract removal). It prevents the pupil of the||
1049|017|U|eye from narrowing. This effect makes it easier for the doctor to||
1049|018|U|examine the inside of the eye, to remove the cataract, and to||
1049|019|U|replace it with a new lens. Flurbiprofen belongs to a class of||
1049|020|U|drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs).||
1049|021|B|||
1049|022|V|OTHER USES:  This section contains uses of this drug that are not||
1049|023|V|listed in the approved professional labeling for the drug but||
1049|024|V|that may be prescribed by your health care professional. Use this||
1049|025|V|drug for a condition that is listed in this section only if it||
1049|026|V|has been so prescribed by your health care professional.||
1049|027|V|   This drug may also be used for pain, swelling, and redness||
1049|028|V|after eye surgery.||
1049|029|B|||
1049|030|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1049|031|H|directed by your doctor, usually every 30 minutes starting 2||
1049|032|H|hours before surgery for a total of 4 drops. If you are directed||
1049|033|H|to use this medication after eye surgery, follow your doctor's||
1049|034|H|instructions.||
1049|035|H|   Do not wear contact lenses while you are using this medicine.||
1049|036|H|Sterilize contact lenses according to the manufacturer's||
1049|037|H|directions, and check with your doctor before you begin using||
1049|038|H|them again.||
1049|039|H|   To apply eye drops, wash your hands first. To avoid||
1049|040|H|contamination, do not touch the dropper tip or let it touch your||
1049|041|H|eye or any other surface.||
1049|042|H|   Tilt your head back, look upward, and pull down the lower||
1049|043|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1049|044|H|and place 1 drop into the pouch. Look downward and gently close||
1049|045|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
1049|046|H|your eye (near the nose) and apply gentle pressure. This will||
1049|047|H|prevent the medication from draining out. Try not to blink and do||
1049|048|H|not rub your eye.||
1049|049|H|   Do not rinse the dropper. Replace the dropper cap after each||
1049|050|H|use.||
1049|051|H|   If you are using another kind of eye medication (for example,||
1049|052|H|other drops or ointments), wait at least 5 to 10 minutes before||
1049|053|H|applying other medications. Use eye drops before eye ointments to||
1049|054|H|allow the drops to enter the eye.||
1049|055|H|   This medication is intended for short-term use only. Do not||
1049|056|H|use this medication more often or for longer than prescribed||
1049|057|H|because doing so may increase your risk of serious side effects.||
1049|058|H|   Do not use this product if it becomes contaminated (for||
1049|059|H|example, drops turn cloudy or a dark color). Use of contaminated||
1049|060|H|eye medication can cause infection, serious damage to the eye,||
1049|061|H|and loss of vision. Contact your doctor or pharmacist for more||
1049|062|H|information.||
1049|063|H|   If you are instructed to use this medication after eye||
1049|064|H|surgery, tell your doctor if your symptoms last or get worse.||
1049|065|B|||
1049|066|S|SIDE EFFECTS:  Stinging/burning of the eyes for 1 to 2 minutes||
1049|067|S|may occur when you apply this medication. If any of these effects||
1049|068|S|last or get worse, tell your doctor or pharmacist promptly.||
1049|069|S|   Remember that this medication has been prescribed because your||
1049|070|S|doctor has judged that the benefit to you is greater than the||
1049|071|S|risk of side effects. Many people using this medication do not||
1049|072|S|have serious side effects.||
1049|073|S|   Tell your doctor right away if you have any serious side||
1049|074|S|effects, including: eye pain, decreased vision, bleeding in the||
1049|075|S|eye (increased redness in the eye).||
1049|076|S|   A very serious allergic reaction to this drug is rare.||
1049|077|S|However, get medical help right away if you notice any symptoms||
1049|078|S|of a serious allergic reaction, including: rash, itching/swelling||
1049|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1049|080|S|breathing.||
1049|081|S|   This is not a complete list of possible side effects. If you||
1049|082|S|notice other effects not listed above, contact your doctor or||
1049|083|S|pharmacist.||
1049|084|S|   In the US -||
1049|085|S|   Call your doctor for medical advice about side effects. You||
1049|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1049|087|S|www.fda.gov/medwatch.||
1049|088|S|   In Canada - Call your doctor for medical advice about side||
1049|089|S|effects. You may report side effects to Health Canada at||
1049|090|S|1-866-234-2345.||
1049|091|B|||
1049|092|P|PRECAUTIONS:  Before using flurbiprofen, tell your doctor or||
1049|093|P|pharmacist if you are allergic to it; or to aspirin or other||
1049|094|P|NSAIDs (such as ibuprofen, celecoxib); or if you have any other||
1049|095|P|allergies. This product may contain inactive ingredients (such as||
1049|096|P|preservatives like thimerosal), which can cause allergic||
1049|097|P|reactions or other problems. Talk to your pharmacist for more||
1049|098|P|details.||
1049|099|P|   Before using this medication, tell your doctor or pharmacist||
1049|100|P|your medical history, especially of: asthma (including a history||
1049|101|P|of worsening breathing after taking aspirin or other NSAIDs),||
1049|102|P|growths in the nose (nasal polyps), bleeding or clotting||
1049|103|P|problems, other eye problems (such as cornea problems, dry eye||
1049|104|P|syndrome, past eye surgeries), diabetes, rheumatoid arthritis.||
1049|105|P|   After you apply this drug, your vision may become temporarily||
1049|106|P|blurred or unstable. Do not drive, use machinery, or do anything||
1049|107|P|that needs clear vision until you can do it safely.||
1049|108|P|   Before having surgery, tell your doctor or dentist about all||
1049|109|P|the products you use (including prescription drugs,||
1049|110|P|nonprescription drugs, and herbal products).||
1049|111|P|   During pregnancy, this medication should be used only when||
1049|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
1049|113|P|   It is unknown if this drug passes into breast milk. Consult||
1049|114|P|your doctor before breastfeeding.||
1049|115|B|||
1049|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1049|117|I|medications work or increase your risk for serious side effects.||
1049|118|I|This document does not contain all possible drug interactions.||
1049|119|I|Keep a list of all the products you use (including||
1049|120|I|prescription/nonprescription drugs and herbal products) and share||
1049|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
1049|122|I|the dosage of any medicines without your doctor's approval.||
1049|123|I|   Some products that may interact with this drug include:||
1049|124|I|corticosteroids (such as prednisone).||
1049|125|I|   This medication may increase the risk of bleeding when used||
1049|126|I|with other drugs that also may cause bleeding. Examples include||
1049|127|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1049|128|I|dabigatran/enoxaparin/warfarin, among others.||
1049|129|I|   Check all prescription and nonprescription medicine labels||
1049|130|I|carefully since many medications contain pain relievers/fever||
1049|131|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These||
1049|132|I|drugs are similar to flurbiprofen and may increase your risk of||
1049|133|I|side effects if taken together. However, if your doctor has told||
1049|134|I|you to take low-dose aspirin to prevent heart attack or stroke||
1049|135|I|(usually 81-162 milligrams a day), you should keep taking the||
1049|136|I|aspirin unless your doctor tells you not to. Ask your doctor or||
1049|137|I|pharmacist for more details.||
1049|138|B|||
1049|139|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1049|140|O|has overdosed and has serious symptoms such as passing out or||
1049|141|O|trouble breathing, call 911. Otherwise, call a poison control||
1049|142|O|center right away. US residents can call 1-800-222-1222. Canada||
1049|143|O|residents can call 1-844-764-7669.||
1049|144|B|||
1049|145|N|NOTES:  Do not share this medication with others.||
1049|146|N|   This medication has been prescribed for your current condition||
1049|147|N|only. Do not use it later for another eye condition unless told||
1049|148|N|to do so by your doctor. A different medication may be necessary||
1049|149|N|in that case.||
1049|150|B|||
1049|151|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1049|152|D|If it is near the time of the next dose, skip the missed dose.||
1049|153|D|Use your next dose at the regular time. Do not double the dose to||
1049|154|D|catch up.||
1049|155|B|||
1049|156|R|STORAGE:  Store at room temperature away from light. Keep all||
1049|157|R|medications away from children and pets.||
1049|158|R|   Do not flush medications down the toilet or pour them into a||
1049|159|R|drain unless instructed to do so. Properly discard this product||
1049|160|R|when it is expired or no longer needed. Consult your pharmacist||
1049|161|R|or local waste disposal company.||
1049|162|B|||
1049|163|A|Information last revised May 2024.||
1049|164|A|Copyright(c) 2025 First Databank, Inc.||
1049|165|B|||
1050|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1050|002|Z|does NOT have all possible information about this product. This||
1050|003|Z|information does not assure that this product is safe, effective,||
1050|004|Z|or appropriate for you. This information is not individual||
1050|005|Z|medical advice and does not substitute for the advice of your||
1050|006|Z|health care professional. Always ask your health care||
1050|007|Z|professional for complete information about this product and your||
1050|008|Z|specific health needs.||
1050|009|B|||
1050|010|T|PENICILLIN V POTASSIUM LIQUID - ORAL||
1050|011|F|(pen-ih-SILL-in VEE poh-TASS-ee-um)||
1050|012|B|||
1050|013|C|COMMON BRAND NAME(S): Pen-Vee K, Veetids||
1050|014|B|||
1050|015|U|USES:  Penicillin is an antibiotic used to treat and prevent a||
1050|016|U|wide variety of bacterial infections. It works by stopping the||
1050|017|U|growth of bacteria.||
1050|018|U|   This antibiotic treats only bacterial infections. It will not||
1050|019|U|work for viral infections (such as common cold, flu). Using any||
1050|020|U|antibiotic when it is not needed can cause it to not work for||
1050|021|U|future infections.||
1050|022|B|||
1050|023|H|HOW TO USE:  Shake the bottle well before each dose. Carefully||
1050|024|H|measure the dose using a special measuring device/spoon. Do not||
1050|025|H|use a household spoon because you may not get the correct dose.||
1050|026|H|This medication may be taken with or without food. However,||
1050|027|H|penicillin is best absorbed when taken on an empty stomach (1||
1050|028|H|hour before or 2 hours after meals).||
1050|029|H|   The dosage is based on your medical condition and response to||
1050|030|H|treatment. Children's dosage is also based on weight.||
1050|031|H|   For the best effect, take this antibiotic at evenly spaced||
1050|032|H|times. To help you remember, take this medication at the same||
1050|033|H|time(s) every day.||
1050|034|H|   Continue to take this medication until the full prescribed||
1050|035|H|amount is finished, even if symptoms disappear after a few days.||
1050|036|H|Stopping the medication too early may result in a return of the||
1050|037|H|infection.||
1050|038|H|   Tell your doctor if your condition lasts or gets worse.||
1050|039|B|||
1050|040|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, diarrhea, and||
1050|041|S|mouth sores may occur. If any of these effects last or get worse,||
1050|042|S|notify your doctor or pharmacist promptly.||
1050|043|S|   Although uncommon, you may develop a black, "hairy" tongue||
1050|044|S|while taking this medication. This effect is harmless and usually||
1050|045|S|goes away after treatment. Maintain good oral hygiene, and brush||
1050|046|S|your tongue with a soft toothbrush twice a day. Consult your||
1050|047|S|doctor or pharmacist for more information.||
1050|048|S|   Remember that this medication has been prescribed because your||
1050|049|S|doctor has judged that the benefit to you is greater than the||
1050|050|S|risk of side effects. Many people using this medication do not||
1050|051|S|have serious side effects.||
1050|052|S|   Tell your doctor right away if you have any serious side||
1050|053|S|effects, including: unusual tiredness, joint/muscle pain, easy||
1050|054|S|bruising/bleeding.||
1050|055|S|   This medication may rarely cause a severe intestinal condition||
1050|056|S|due to a bacteria called C. difficile. This condition may occur||
1050|057|S|during treatment or weeks to months after treatment has stopped.||
1050|058|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1050|059|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1050|060|S|stool.||
1050|061|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1050|062|S|products because they may make symptoms worse.||
1050|063|S|   Use of this medication for prolonged or repeated periods may||
1050|064|S|result in oral thrush or a new vaginal yeast infection (oral or||
1050|065|S|vaginal fungal infection). Contact your doctor if you notice||
1050|066|S|white patches in your mouth, a change in vaginal discharge or||
1050|067|S|other new symptoms.||
1050|068|S|   A very serious allergic reaction to this drug is rare.||
1050|069|S|However, get medical help right away if you notice any symptoms||
1050|070|S|of a serious allergic reaction, including: rash, itching/swelling||
1050|071|S|(especially of the face/tongue/throat), new fever, severe||
1050|072|S|dizziness, trouble breathing.||
1050|073|S|   This is not a complete list of possible side effects. If you||
1050|074|S|notice other effects not listed above, contact your doctor or||
1050|075|S|pharmacist.||
1050|076|S|   In the US -||
1050|077|S|   Call your doctor for medical advice about side effects. You||
1050|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1050|079|S|www.fda.gov/medwatch.||
1050|080|S|   In Canada - Call your doctor for medical advice about side||
1050|081|S|effects. You may report side effects to Health Canada at||
1050|082|S|1-866-234-2345.||
1050|083|B|||
1050|084|P|PRECAUTIONS:  Before taking penicillin, tell your doctor or||
1050|085|P|pharmacist if you are allergic to it; or to other antibiotics||
1050|086|P|including penicillin-type medications (such as amoxicillin,||
1050|087|P|ampicillin) or cephalosporins (such as cephalexin, cefuroxime);||
1050|088|P|or if you have any other allergies. This product may contain||
1050|089|P|inactive ingredients, which can cause allergic reactions or other||
1050|090|P|problems. Talk to your pharmacist for more details.||
1050|091|P|   Before using this medication, tell your doctor or pharmacist||
1050|092|P|your medical history, especially of: kidney problems.||
1050|093|P|   This medication may contain aspartame. If you have||
1050|094|P|phenylketonuria (PKU) or any other condition that requires you to||
1050|095|P|restrict your intake of aspartame (or phenylalanine), consult||
1050|096|P|your doctor or pharmacist regarding the safe use of this||
1050|097|P|medicine.||
1050|098|P|   Penicillin may cause live bacterial vaccines (such as typhoid||
1050|099|P|vaccine) to not work well. Tell your health care professional||
1050|100|P|that you are using penicillin before having any||
1050|101|P|immunizations/vaccinations.||
1050|102|P|   During pregnancy, this medication should be used only when||
1050|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
1050|104|P|   This drug passes into breast milk. Consult your doctor before||
1050|105|P|breastfeeding.||
1050|106|B|||
1050|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1050|108|I|medications work or increase your risk for serious side effects.||
1050|109|I|This document does not contain all possible drug interactions.||
1050|110|I|Keep a list of all the products you use (including||
1050|111|I|prescription/nonprescription drugs and herbal products) and share||
1050|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
1050|113|I|the dosage of any medicines without your doctor's approval.||
1050|114|I|   Some products that may interact with this drug are:||
1050|115|I|methotrexate, khat, guar gum.||
1050|116|I|   This medication may interfere with certain lab tests (such as||
1050|117|I|certain diabetic urine tests), possibly causing false test||
1050|118|I|results. Make sure lab personnel and all your doctors know you||
1050|119|I|use this drug.||
1050|120|B|||
1050|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1050|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1050|123|O|poison control center right away. US residents can call||
1050|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1050|125|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
1050|126|O|severe vomiting.||
1050|127|B|||
1050|128|N|NOTES:  Do not share this medication with others.||
1050|129|N|   This medication has been prescribed for your current condition||
1050|130|N|only. Do not use it later for another infection unless your||
1050|131|N|doctor tells you to.||
1050|132|N|   With long term treatment, lab and/or medical tests (such as||
1050|133|N|kidney function, complete blood counts) should be done while you||
1050|134|N|are taking this medication. Keep all medical and lab||
1050|135|N|appointments. Consult your doctor for more details.||
1050|136|B|||
1050|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1050|138|D|remember. If it is near the time of the next dose, skip the||
1050|139|D|missed dose. Take your next dose at the regular time. Do not||
1050|140|D|double the dose to catch up.||
1050|141|B|||
1050|142|R|STORAGE:  Store in the refrigerator. Throw away any unused||
1050|143|R|portion after 14 days since the drug loses potency after that||
1050|144|R|time. Keep all medications away from children and pets.||
1050|145|R|   Do not flush medications down the toilet or pour them into a||
1050|146|R|drain unless instructed to do so. Properly discard this product||
1050|147|R|when it is expired or no longer needed. Consult your pharmacist||
1050|148|R|or local waste disposal company.||
1050|149|B|||
1050|150|A|Information last revised October 2024.||
1050|151|A|Copyright(c) 2025 First Databank, Inc.||
1050|152|B|||
1051|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1051|002|Z|does NOT have all possible information about this product. This||
1051|003|Z|information does not assure that this product is safe, effective,||
1051|004|Z|or appropriate for you. This information is not individual||
1051|005|Z|medical advice and does not substitute for the advice of your||
1051|006|Z|health care professional. Always ask your health care||
1051|007|Z|professional for complete information about this product and your||
1051|008|Z|specific health needs.||
1051|009|B|||
1051|010|T|ALMOTRIPTAN - ORAL||
1051|011|F|(AL-moe-TRIP-tan)||
1051|012|B|||
1051|013|C|COMMON BRAND NAME(S): Axert||
1051|014|B|||
1051|015|U|USES:  Almotriptan is used to treat migraines. It helps to||
1051|016|U|relieve headache, pain, and other migraine symptoms (including||
1051|017|U|nausea, vomiting, sensitivity to light/sound). Prompt treatment||
1051|018|U|helps you return to your normal routine and may decrease your||
1051|019|U|need for other pain medications. Almotriptan belongs to a class||
1051|020|U|of drugs known as triptans. It affects a certain natural||
1051|021|U|substance (serotonin) that narrows blood vessels in the brain. It||
1051|022|U|may also relieve pain by affecting certain nerves in the brain.||
1051|023|U|   Almotriptan does not prevent future migraines or lessen how||
1051|024|U|often you get migraine attacks.||
1051|025|B|||
1051|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1051|027|H|from your pharmacist before you start taking almotriptan and each||
1051|028|H|time you get a refill. If you have any questions, ask your doctor||
1051|029|H|or pharmacist.||
1051|030|H|   If you have a higher risk for heart problems (see||
1051|031|H|Precautions), your doctor may perform a heart exam before you||
1051|032|H|start taking almotriptan. He/she may also direct you to use your||
1051|033|H|first dose of this medication in the office/clinic to monitor for||
1051|034|H|serious side effects (such as chest pain). Talk to your doctor||
1051|035|H|for details.||
1051|036|H|   Take this medication by mouth with or without food as directed||
1051|037|H|by your doctor at the first sign of a migraine. Do not take||
1051|038|H|almotriptan to prevent a migraine.||
1051|039|H|   If there is no improvement in your symptoms, do not take more||
1051|040|H|doses of this medication before talking to your doctor. If your||
1051|041|H|symptoms are only partly relieved, or if your headache comes||
1051|042|H|back, you may take a second dose after 2 hours. Do not take more||
1051|043|H|than 2 doses in a 24-hour period.||
1051|044|H|   The dosage is based on your medical condition, response to||
1051|045|H|treatment, and other medications you may be taking. Be sure to||
1051|046|H|tell your doctor and pharmacist about all the products you use||
1051|047|H|(including prescription drugs, nonprescription drugs, and herbal||
1051|048|H|products).||
1051|049|H|   If you are using drugs for migraine attacks on 10 or more days||
1051|050|H|each month, the drugs may actually make your headaches worse||
1051|051|H|(medication overuse headache). Do not use medications more often||
1051|052|H|or for longer than directed. Tell your doctor if you need to use||
1051|053|H|this medication more often, or if the medication is not working||
1051|054|H|as well, or if your headaches get worse.||
1051|055|B|||
1051|056|S|SIDE EFFECTS:  Drowsiness, dizziness, nausea, sensations of||
1051|057|S|tingling/numbness/prickling, or dry mouth may occur. If any of||
1051|058|S|these effects last or get worse, tell your doctor or pharmacist||
1051|059|S|promptly.||
1051|060|S|   Remember that this medication has been prescribed because your||
1051|061|S|doctor has judged that the benefit to you is greater than the||
1051|062|S|risk of side effects. Many people using this medication do not||
1051|063|S|have serious side effects.||
1051|064|S|   Tell your doctor right away if you have any serious side||
1051|065|S|effects, including: blue fingers/toes/nails, cold sensation of||
1051|066|S|hands/feet, hearing changes, mental/mood changes.||
1051|067|S|   This medication may raise your blood pressure. Check your||
1051|068|S|blood pressure regularly and tell your doctor if the results are||
1051|069|S|high.||
1051|070|S|   Almotriptan can commonly cause chest/jaw/neck tightness, pain,||
1051|071|S|or pressure that is usually not serious. However, these side||
1051|072|S|effects are like symptoms of a heart attack, which may include||
1051|073|S|chest/jaw/left arm pain, shortness of breath, or unusual||
1051|074|S|sweating. Get medical help right away if these or other serious||
1051|075|S|side effects occur, including: fast/irregular heartbeat,||
1051|076|S|fainting, severe stomach/abdominal pain, bloody diarrhea, signs||
1051|077|S|of a stroke (such as weakness on one side of the body, trouble||
1051|078|S|speaking, sudden vision changes, confusion).||
1051|079|S|   This medication may increase serotonin and rarely cause a very||
1051|080|S|serious condition called serotonin syndrome/toxicity. The risk||
1051|081|S|increases if you are also taking other drugs that increase||
1051|082|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1051|083|S|take (see Drug Interactions section). Get medical help right away||
1051|084|S|if you develop some of the following symptoms: fast heartbeat,||
1051|085|S|hallucinations, loss of coordination, severe dizziness, severe||
1051|086|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1051|087|S|unusual agitation/restlessness.||
1051|088|S|   A very serious allergic reaction to this drug is rare.||
1051|089|S|However, get medical help right away if you notice any symptoms||
1051|090|S|of a serious allergic reaction, including: rash, itching/swelling||
1051|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1051|092|S|breathing.||
1051|093|S|   This is not a complete list of possible side effects. If you||
1051|094|S|notice other effects not listed above, contact your doctor or||
1051|095|S|pharmacist.||
1051|096|S|   In the US -||
1051|097|S|   Call your doctor for medical advice about side effects. You||
1051|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1051|099|S|www.fda.gov/medwatch.||
1051|100|S|   In Canada - Call your doctor for medical advice about side||
1051|101|S|effects. You may report side effects to Health Canada at||
1051|102|S|1-866-234-2345.||
1051|103|B|||
1051|104|P|PRECAUTIONS:  See also How to Use section.||
1051|105|P|   Before taking almotriptan, tell your doctor or pharmacist if||
1051|106|P|you are allergic to it; or to other triptan migraine drugs; or if||
1051|107|P|you have any other allergies. This product may contain inactive||
1051|108|P|ingredients, which can cause allergic reactions or other||
1051|109|P|problems. Talk to your pharmacist for more details.||
1051|110|P|   Before using this medication, tell your doctor or pharmacist||
1051|111|P|your medical history, especially of: blood circulation problems||
1051|112|P|(for example, in your legs, arms/hands, or stomach), certain||
1051|113|P|types of headaches (hemiplegic or basilar migraine), heart||
1051|114|P|problems (such as chest pain, irregular heartbeat, previous heart||
1051|115|P|attack), stroke or "mini-stroke" (transient ischemic attack),||
1051|116|P|kidney disease, liver disease.||
1051|117|P|   Certain conditions can increase your risk for heart problems.||
1051|118|P|Tell your doctor if you have any of these conditions, including:||
1051|119|P|diabetes, family history of heart disease, high blood pressure,||
1051|120|P|high cholesterol, overweight, smoker, postmenopausal (women), age||
1051|121|P|more than 40 years (men).||
1051|122|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1051|123|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1051|124|P|machinery, or do anything that needs alertness until you can do||
1051|125|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1051|126|P|are using marijuana (cannabis).||
1051|127|P|   Before having surgery, tell your doctor or dentist about all||
1051|128|P|the products you use (including prescription drugs,||
1051|129|P|nonprescription drugs, and herbal products).||
1051|130|P|   The risk of heart disease, liver disease, and high blood||
1051|131|P|pressure increases with age. Older adults may be more sensitive||
1051|132|P|to the side effects of this drug, especially increased blood||
1051|133|P|pressure and heart problems.||
1051|134|P|   During pregnancy, this medication should be used only when||
1051|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
1051|136|P|   It is unknown if this medication passes into breast milk.||
1051|137|P|Consult your doctor before breastfeeding.||
1051|138|B|||
1051|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1051|140|I|medications work or increase your risk for serious side effects.||
1051|141|I|This document does not contain all possible drug interactions.||
1051|142|I|Keep a list of all the products you use (including||
1051|143|I|prescription/nonprescription drugs and herbal products) and share||
1051|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
1051|145|I|the dosage of any medicines without your doctor's approval.||
1051|146|I|   The risk of serotonin syndrome/toxicity increases if you are||
1051|147|I|also taking other drugs that increase serotonin. Examples include||
1051|148|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1051|149|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1051|150|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1051|151|I|serotonin syndrome/toxicity may be more likely when you start or||
1051|152|I|increase the dose of these drugs.||
1051|153|I|   If you also take any ergotamine medication (such as||
1051|154|I|dihydroergotamine) or other "triptan" drugs (such as||
1051|155|I|zolmitriptan, rizatriptan), you will need to separate your||
1051|156|I|almotriptan dose from your dose of these other medications to||
1051|157|I|lessen the chance of serious side effects. Ask your doctor how||
1051|158|I|long you should wait between your doses of these drugs.||
1051|159|B|||
1051|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1051|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1051|162|O|poison control center right away. US residents can call||
1051|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1051|164|B|||
1051|165|N|NOTES:  Do not share this medication with others.||
1051|166|N|   Certain foods, beverages, or food additives (such as red wine,||
1051|167|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
1051|168|N|patterns such as irregular eating/sleeping habits or stress may||
1051|169|N|bring on a migraine headache. Avoiding such "triggers" may help||
1051|170|N|lessen migraine attacks. Consult your doctor for more details.||
1051|171|N|   Lab and/or medical tests (such as blood pressure) may be done||
1051|172|N|while you are using this medication. Keep all medical and lab||
1051|173|N|appointments.||
1051|174|B|||
1051|175|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
1051|176|B|||
1051|177|R|STORAGE:  Store at room temperature away from light and moisture.||
1051|178|R|Keep all medications away from children and pets.||
1051|179|R|   Do not flush medications down the toilet or pour them into a||
1051|180|R|drain unless instructed to do so. Properly discard this product||
1051|181|R|when it is expired or no longer needed. Consult your pharmacist||
1051|182|R|or local waste disposal company.||
1051|183|B|||
1051|184|A|Information last revised May 2024.||
1051|185|A|Copyright(c) 2025 First Databank, Inc.||
1051|186|B|||
1052|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1052|002|Z|does NOT have all possible information about this product. This||
1052|003|Z|information does not assure that this product is safe, effective,||
1052|004|Z|or appropriate for you. This information is not individual||
1052|005|Z|medical advice and does not substitute for the advice of your||
1052|006|Z|health care professional. Always ask your health care||
1052|007|Z|professional for complete information about this product and your||
1052|008|Z|specific health needs.||
1052|009|B|||
1052|010|T|KETOCONAZOLE CREAM - TOPICAL||
1052|011|F|(kee-toe-CON-uh-zole)||
1052|012|B|||
1052|013|C|COMMON BRAND NAME(S): Nizoral||
1052|014|B|||
1052|015|U|USES:  Ketoconazole is used to treat skin infections such as||
1052|016|U|athlete's foot, jock itch, ringworm, and certain kinds of||
1052|017|U|dandruff. This medication is also used to treat a skin condition||
1052|018|U|known as pityriasis (tinea versicolor), a fungal infection that||
1052|019|U|causes a lightening or darkening of the skin of the neck, chest,||
1052|020|U|arms, or legs. Ketoconazole is an azole antifungal that works by||
1052|021|U|preventing the growth of fungus.||
1052|022|B|||
1052|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
1052|024|H|thoroughly dry the area to be treated. Apply this medication to||
1052|025|H|the affected skin, usually once or twice a day or as directed by||
1052|026|H|your doctor. The dosage and length of treatment depends on the||
1052|027|H|type of infection being treated. Do not apply this more often||
1052|028|H|than prescribed. Your condition will not clear faster, but side||
1052|029|H|effects may be increased.||
1052|030|H|   Apply enough medication to cover the affected skin and some of||
1052|031|H|the surrounding skin. After applying this medication, wash your||
1052|032|H|hands. Do not wrap, cover or bandage the area unless directed to||
1052|033|H|do so by your doctor.||
1052|034|H|   Do not apply this medication in the eyes, nose, mouth, or||
1052|035|H|vagina. If this medication gets in the eyes (for example, when||
1052|036|H|used to treat dandruff), rinse thoroughly with water.||
1052|037|H|   Use this medication regularly in order to get the most benefit||
1052|038|H|from it. Remember to use it at the same time(s) each day.||
1052|039|H|   Continue to use this medication until the full prescribed||
1052|040|H|amount is finished, even if symptoms disappear after a few days.||
1052|041|H|Stopping the medication too early may result in a return of the||
1052|042|H|infection.||
1052|043|H|   Tell your doctor if your condition lasts after the prescribed||
1052|044|H|amount of treatment or if it gets worse at any time.||
1052|045|B|||
1052|046|S|SIDE EFFECTS:  Stinging, swelling, irritation, or redness of the||
1052|047|S|treated skin may occur. If any of these effects last or get||
1052|048|S|worse, notify your doctor or pharmacist promptly.||
1052|049|S|   Remember that this medication has been prescribed because your||
1052|050|S|doctor has judged that the benefit to you is greater than the||
1052|051|S|risk of side effects. Many people using this medication do not||
1052|052|S|have serious side effects.||
1052|053|S|   Tell your doctor right away if you have any serious side||
1052|054|S|effects, including: blistering, open sores.||
1052|055|S|   A very serious allergic reaction to this drug is rare.||
1052|056|S|However, get medical help right away if you notice any symptoms||
1052|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1052|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1052|059|S|breathing.||
1052|060|S|   This is not a complete list of possible side effects. If you||
1052|061|S|notice other effects not listed above, contact your doctor or||
1052|062|S|pharmacist.||
1052|063|S|   In the US -||
1052|064|S|   Call your doctor for medical advice about side effects. You||
1052|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1052|066|S|www.fda.gov/medwatch.||
1052|067|S|   In Canada - Call your doctor for medical advice about side||
1052|068|S|effects. You may report side effects to Health Canada at||
1052|069|S|1-866-234-2345.||
1052|070|B|||
1052|071|P|PRECAUTIONS:  Before using ketoconazole, tell your doctor or||
1052|072|P|pharmacist if you are allergic to it; or to other azole||
1052|073|P|antifungals such as clotrimazole, econazole, or miconazole; or if||
1052|074|P|you have any other allergies. This product may contain inactive||
1052|075|P|ingredients, which can cause allergic reactions or other||
1052|076|P|problems. Talk to your pharmacist for more details.||
1052|077|P|   Before using this medication, tell your doctor or pharmacist||
1052|078|P|your medical history.||
1052|079|P|   Before having surgery, tell your doctor or dentist about all||
1052|080|P|the products you use (including prescription drugs,||
1052|081|P|nonprescription drugs, and herbal products).||
1052|082|P|   This medication should be used only if clearly needed during||
1052|083|P|pregnancy. Discuss the risks and benefits with your doctor.||
1052|084|P|   It is unknown if this drug passes into breast milk. Consult||
1052|085|P|your doctor before breastfeeding.||
1052|086|B|||
1052|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1052|088|I|medications work or increase your risk for serious side effects.||
1052|089|I|This document does not contain all possible drug interactions.||
1052|090|I|Keep a list of all the products you use (including||
1052|091|I|prescription/nonprescription drugs and herbal products) and share||
1052|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
1052|093|I|the dosage of any medicines without your doctor's approval.||
1052|094|B|||
1052|095|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1052|096|O|has overdosed and has serious symptoms such as passing out or||
1052|097|O|trouble breathing, call 911. Otherwise, call a poison control||
1052|098|O|center right away. US residents can call 1-800-222-1222. Canada||
1052|099|O|residents can call 1-844-764-7669.||
1052|100|B|||
1052|101|N|NOTES:  Do not share this medication with others.||
1052|102|N|   This medication has been prescribed for your current condition||
1052|103|N|only. Do not use it later for another infection unless your||
1052|104|N|doctor tells you to.||
1052|105|N|   When treating pityriasis, this medication may not cause an||
1052|106|N|immediate return to normal skin color. It may take several months||
1052|107|N|after treatment is completed for your natural skin color to||
1052|108|N|return.||
1052|109|B|||
1052|110|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1052|111|D|If it is near the time of the next dose, skip the missed dose.||
1052|112|D|Use your next dose at the regular time. Do not double the dose to||
1052|113|D|catch up.||
1052|114|B|||
1052|115|R|STORAGE:  Store at room temperature. Keep all medications away||
1052|116|R|from children and pets.||
1052|117|R|   Do not flush medications down the toilet or pour them into a||
1052|118|R|drain unless instructed to do so. Properly discard this product||
1052|119|R|when it is expired or no longer needed. Consult your pharmacist||
1052|120|R|or local waste disposal company.||
1052|121|B|||
1052|122|A|Information last revised November 2025.||
1052|123|A|Copyright(c) 2025 First Databank, Inc.||
1052|124|B|||
1054|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1054|002|Z|does NOT have all possible information about this product. This||
1054|003|Z|information does not assure that this product is safe, effective,||
1054|004|Z|or appropriate for you. This information is not individual||
1054|005|Z|medical advice and does not substitute for the advice of your||
1054|006|Z|health care professional. Always ask your health care||
1054|007|Z|professional for complete information about this product and your||
1054|008|Z|specific health needs.||
1054|009|B|||
1054|010|T|DECONGESTANT/OPIOID ANTITUSSIVE/GUAIFENESIN - ORAL||
1054|011|B|||
1054|012|C|COMMON BRAND NAME(S): Maxifed CD, Maxifed-G CD||
1054|013|B|||
1054|014|W|WARNING:  This medication has a risk for abuse and addiction,||
1054|015|W|which can lead to overdose and death. This medication may also||
1054|016|W|cause severe, possibly fatal, breathing problems. To lower your||
1054|017|W|risk, your doctor should have you take the smallest dose that||
1054|018|W|works, and take it for the shortest possible time. See also How||
1054|019|W|to Use section for more information about addiction.||
1054|020|W|   The risk for severe breathing problems is higher when you||
1054|021|W|start this medication, or if you take the wrong dose or take more||
1054|022|W|of this medication than prescribed. Taking this medication with||
1054|023|W|alcohol or other drugs that can cause drowsiness or breathing||
1054|024|W|problems may cause very serious side effects, including death.||
1054|025|W|Also, other medications can affect the removal of this product||
1054|026|W|from your body, which may affect how it works. Be sure you know||
1054|027|W|how to take this product and what other drugs you should avoid||
1054|028|W|taking with it. See also Drug Interactions section. Get medical||
1054|029|W|help right away if any of these very serious side effects occur:||
1054|030|W|slow/shallow breathing, unusual lightheadedness, severe||
1054|031|W|drowsiness/dizziness, difficulty waking up.||
1054|032|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1054|033|W|or abuse. If someone accidentally swallows this drug, get medical||
1054|034|W|help right away.||
1054|035|W|   Before using this medication, women of childbearing age should||
1054|036|W|talk with their doctor(s) about the risks and benefits. Tell your||
1054|037|W|doctor if you are pregnant or think you may be pregnant. During||
1054|038|W|pregnancy, this medication is not recommended. It may slightly||
1054|039|W|increase the risk of birth defects if used during the first two||
1054|040|W|months of pregnancy. Also, using it for a long time or in high||
1054|041|W|doses near the expected delivery date may harm the unborn baby.||
1054|042|W|To lessen the risk, take the smallest effective dose for the||
1054|043|W|shortest possible time. Babies born to mothers who use this drug||
1054|044|W|for a long time may develop severe (possibly fatal) withdrawal||
1054|045|W|symptoms. Tell the doctor right away if you notice any symptoms||
1054|046|W|in your newborn baby such as crying that doesn't stop,||
1054|047|W|slow/shallow breathing, irritability, shaking, vomiting,||
1054|048|W|diarrhea, poor feeding, or difficulty gaining weight.||
1054|049|B|||
1054|050|U|USES:  This combination medication is used to temporarily treat||
1054|051|U|cough, chest congestion, and stuffy nose symptoms caused by the||
1054|052|U|common cold, flu, or other breathing illnesses (such as||
1054|053|U|sinusitis, bronchitis). Guaifenesin is an expectorant that helps||
1054|054|U|thin and loosen mucus in the lungs, making it easier to cough up||
1054|055|U|the mucus. The decongestant helps relieve stuffy nose symptoms.||
1054|056|U|This product also contains an opioid cough suppressant||
1054|057|U|(antitussive) that affects a certain part of the brain, reducing||
1054|058|U|the urge to cough.||
1054|059|U|   This medication is not usually used for ongoing coughs from||
1054|060|U|smoking, asthma, other long-term breathing problems (such as||
1054|061|U|emphysema), or coughs with a lot of mucus unless directed by your||
1054|062|U|doctor.||
1054|063|U|   Opioid cough suppressants should not be used by children||
1054|064|U|younger than 18 years. Children are at higher risk for serious||
1054|065|U|(even fatal) side effects, especially breathing problems. Talk||
1054|066|U|with the doctor about the risks and benefits of this medication.||
1054|067|U|   Cough-and-cold products do not cure colds. Cough due to a||
1054|068|U|common cold often does not need to be treated with medicine. Ask||
1054|069|U|your doctor or pharmacist about other ways to relieve cough and||
1054|070|U|cold symptoms, such as drinking enough fluids, using a||
1054|071|U|humidifier, or saline nose drops/spray.||
1054|072|B|||
1054|073|H|HOW TO USE:  Read the Medication Guide provided by your||
1054|074|H|pharmacist before you start taking this product and each time you||
1054|075|H|get a refill. If you have any questions, ask your doctor or||
1054|076|H|pharmacist.||
1054|077|H|   Take this medication by mouth with or without food with a full||
1054|078|H|glass of water (8 ounces or 240 milliliters) as directed by your||
1054|079|H|doctor. This medication can be taken with food if stomach upset||
1054|080|H|occurs. Drink plenty of fluids when you use this medication||
1054|081|H|unless otherwise directed by your doctor. The fluid will help||
1054|082|H|loosen the mucus in your lungs.||
1054|083|H|   If you are using the liquid form, use a medication-measuring||
1054|084|H|device or spoon to carefully measure the prescribed dose. Do not||
1054|085|H|use a household spoon because you may not get the correct dose.||
1054|086|H|If your liquid form is a suspension, shake the bottle well before||
1054|087|H|each dose.||
1054|088|H|   The dosage is based on your medical condition and response to||
1054|089|H|treatment.||
1054|090|H|   Do not increase your dose or use this product more often or||
1054|091|H|for longer than prescribed. Your condition will not improve any||
1054|092|H|faster, and your risk of side effects will increase.||
1054|093|H|   If you suddenly stop using this medication, you may have||
1054|094|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
1054|095|H|nose, nausea, sweating, muscle aches). To help prevent||
1054|096|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1054|097|H|more likely if you have used this medication regularly for a long||
1054|098|H|time (more than a few weeks) or in high doses. Tell your doctor||
1054|099|H|or pharmacist right away if you have withdrawal.||
1054|100|H|   Though it helps many people, this product may sometimes cause||
1054|101|H|addiction. This risk may be higher if you have a mental/mood||
1054|102|H|disorder or a substance use disorder (such as overuse of or||
1054|103|H|addiction to drugs/alcohol). Take this product exactly as||
1054|104|H|prescribed to lower the risk of addiction. Ask your doctor or||
1054|105|H|pharmacist for more details.||
1054|106|H|   When used for an extended time, this medication may not work||
1054|107|H|as well and may require different dosing. Talk with your doctor||
1054|108|H|if this medication stops working well.||
1054|109|H|   Tell your doctor if your cough does not get better in 5 days.||
1054|110|H|Also, tell your doctor if your condition gets worse, or if you||
1054|111|H|have a headache that doesn't go away, fever, or rash. These may||
1054|112|H|be symptoms of a serious medical problem and should be checked by||
1054|113|H|a doctor.||
1054|114|B|||
1054|115|S|SIDE EFFECTS:  See also Warning section.||
1054|116|S|   Dizziness, drowsiness, headache, upset stomach, nausea,||
1054|117|S|constipation, nervousness, or trouble sleeping may occur. If any||
1054|118|S|of these effects last or get worse, contact your doctor or||
1054|119|S|pharmacist promptly.||
1054|120|S|   To reduce the risk of dizziness and lightheadedness, get up||
1054|121|S|slowly when rising from a sitting or lying position.||
1054|122|S|   Remember that this medication has been prescribed because your||
1054|123|S|doctor has judged that the benefit to you is greater than the||
1054|124|S|risk of side effects. Many people using this medication do not||
1054|125|S|have serious side effects.||
1054|126|S|   This medication may raise your blood pressure. Check your||
1054|127|S|blood pressure regularly and tell your doctor if the results are||
1054|128|S|high.||
1054|129|S|   Tell your doctor right away if you have any serious side||
1054|130|S|effects, including: interrupted breathing during sleep (sleep||
1054|131|S|apnea), mental/mood changes (such as hallucinations), shaking,||
1054|132|S|trouble urinating, weakness, fast/irregular heartbeat, trouble||
1054|133|S|swallowing.||
1054|134|S|   Get medical help right away if you have any very serious side||
1054|135|S|effects, including: seizure.||
1054|136|S|   This product may cause serious mental/mood changes and very||
1054|137|S|serious (rarely fatal) breathing problems. This product may||
1054|138|S|contain codeine or dihydrocodeine. Codeine and dihydrocodeine are||
1054|139|S|changed into strong opioid drugs (morphine or dihydromorphine) in||
1054|140|S|your body. In some people this happens faster and more completely||
1054|141|S|than usual, which increases the risk of very serious side||
1054|142|S|effects. Get medical help right away if you notice any of the||
1054|143|S|following: slow/shallow breathing, severe drowsiness/difficulty||
1054|144|S|waking up, confusion.||
1054|145|S|   A very serious allergic reaction to this drug is rare.||
1054|146|S|However, get medical help right away if you notice any symptoms||
1054|147|S|of a serious allergic reaction, including: rash, itching/swelling||
1054|148|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1054|149|S|breathing.||
1054|150|S|   This is not a complete list of possible side effects. If you||
1054|151|S|notice other effects not listed above, contact your doctor or||
1054|152|S|pharmacist.||
1054|153|S|   In the US -||
1054|154|S|   Call your doctor for medical advice about side effects. You||
1054|155|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1054|156|S|www.fda.gov/medwatch.||
1054|157|S|   In Canada - Call your doctor for medical advice about side||
1054|158|S|effects. You may report side effects to Health Canada at||
1054|159|S|1-866-234-2345.||
1054|160|B|||
1054|161|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1054|162|P|pharmacist if you are allergic to it; or if you have any other||
1054|163|P|allergies. This product may contain inactive ingredients, which||
1054|164|P|can cause allergic reactions or other problems. Talk to your||
1054|165|P|pharmacist for more details.||
1054|166|P|   Before using this medication, tell your doctor or pharmacist||
1054|167|P|your medical history, especially of: abdominal problems (such as||
1054|168|P|chronic constipation, ileus, gallbladder disease, pancreatitis),||
1054|169|P|adrenal gland problem (such as Addison's disease), blood vessel||
1054|170|P|problems (such as Raynaud's disease, low blood flow to the||
1054|171|P|brain/legs/hands), certain brain disorders (such as head injury,||
1054|172|P|tumor, increased pressure in the brain, seizures), breathing||
1054|173|P|problems (such as asthma, emphysema, sleep apnea), diabetes,||
1054|174|P|glaucoma, heart problems, high blood pressure, kidney problems,||
1054|175|P|liver disease, mental/mood problems (such as depression,||
1054|176|P|psychosis), thyroid problems (such as hyperthyroidism,||
1054|177|P|hypothyroidism), trouble urinating (such as due to enlarged||
1054|178|P|prostate), personal or family history of a substance use disorder||
1054|179|P|(such as overuse of or addiction to drugs/alcohol), obesity.||
1054|180|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1054|181|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1054|182|P|machinery, or do anything that needs alertness until you can do||
1054|183|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1054|184|P|are using marijuana (cannabis).||
1054|185|P|   This medicine may contain aspartame. If you have||
1054|186|P|phenylketonuria (PKU) or any other condition that requires you to||
1054|187|P|restrict your intake of aspartame (or phenylalanine), consult||
1054|188|P|your doctor or pharmacist regarding the safe use of this||
1054|189|P|medicine.||
1054|190|P|   This medication may contain sugar and/or alcohol. Caution is||
1054|191|P|advised if you have diabetes, alcohol dependence, or liver||
1054|192|P|disease. Ask your doctor or pharmacist about the safe use of this||
1054|193|P|product.||
1054|194|P|   Before having surgery, tell your doctor or dentist about all||
1054|195|P|the products you use (including prescription drugs,||
1054|196|P|nonprescription drugs, and herbal products).||
1054|197|P|   Older adults may be more sensitive to the side effects of this||
1054|198|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
1054|199|P|breathing, fast/irregular heartbeat, problems urinating, or||
1054|200|P|trouble sleeping.||
1054|201|P|   Tell your doctor if you are pregnant or think you may be||
1054|202|P|pregnant. During pregnancy, this product is not recommended. It||
1054|203|P|may harm an unborn baby. Talk to your doctor about the risks and||
1054|204|P|benefits of this medication. See also Warning section.||
1054|205|P|   This product may pass into breast milk and may have||
1054|206|P|undesirable effects on a nursing infant (such as unusual||
1054|207|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
1054|208|P|limpness). Consult your doctor before breastfeeding.||
1054|209|B|||
1054|210|I|DRUG INTERACTIONS:  See also Warning section.||
1054|211|I|   Drug interactions may change how your medications work or||
1054|212|I|increase your risk for serious side effects. This document does||
1054|213|I|not contain all possible drug interactions. Keep a list of all||
1054|214|I|the products you use (including prescription/nonprescription||
1054|215|I|drugs and herbal products) and share it with your doctor and||
1054|216|I|pharmacist. Do not start, stop, or change the dosage of any||
1054|217|I|medicines without your doctor's approval.||
1054|218|I|   Some products that may interact with this drug include:||
1054|219|I|naltrexone, samidorphan.||
1054|220|I|   Taking MAO inhibitors with this medication may cause a serious||
1054|221|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1054|222|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1054|223|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1054|224|I|selegiline, tranylcypromine) during treatment with this||
1054|225|I|medication. Most MAO inhibitors should also not be taken for two||
1054|226|I|weeks before treatment with this medication. Ask your doctor when||
1054|227|I|to start or stop taking this medication.||
1054|228|I|   The risk of serious side effects (such as slow/shallow||
1054|229|I|breathing, severe drowsiness/dizziness) may be increased if this||
1054|230|I|medication is taken with other products that may also cause||
1054|231|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1054|232|I|if you are taking other products such as other opioid pain or||
1054|233|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1054|234|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1054|235|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1054|236|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1054|237|I|cetirizine, diphenhydramine).||
1054|238|I|   Guaifenesin and decongestants are available in both||
1054|239|I|prescription and nonprescription products. Check the labels on||
1054|240|I|all your medications carefully to make sure you are not taking||
1054|241|I|more than one product containing these ingredients.||
1054|242|I|   Check the labels on all your medicines (such as allergy or||
1054|243|I|cough-and-cold products) because they may contain ingredients||
1054|244|I|that cause drowsiness. Ask your pharmacist about using those||
1054|245|I|products safely.||
1054|246|I|   Other medications can affect the removal of this product from||
1054|247|I|your body, which may affect how this product works. Examples||
1054|248|I|include azole antifungals (such as ketoconazole), bupropion,||
1054|249|I|fluoxetine, macrolide antibiotics (such as erythromycin),||
1054|250|I|paroxetine, quinidine, rifamycins (such as rifabutin, rifampin),||
1054|251|I|ritonavir, certain drugs used to treat seizures (such as||
1054|252|I|carbamazepine, phenytoin), among others.||
1054|253|I|   This medication may interfere with certain lab tests (such as||
1054|254|I|5-HIAA levels, VMA levels, amylase/lipase levels), possibly||
1054|255|I|causing false test results. Make sure lab personnel and all your||
1054|256|I|doctors know you use this drug.||
1054|257|B|||
1054|258|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1054|259|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1054|260|O|poison control center right away. US residents can call||
1054|261|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1054|262|O|Symptoms of overdose may include: confusion, cold/clammy skin,||
1054|263|O|fast/irregular heartbeat, slow/shallow breathing, seizures, coma.||
1054|264|B|||
1054|265|N|NOTES:  Do not share this medication with others. Sharing it is||
1054|266|N|against the law.||
1054|267|B|||
1054|268|D|MISSED DOSE:  If you are prescribed this medication on a regular||
1054|269|D|schedule and miss a dose, take it as soon as you remember. If it||
1054|270|D|is near the time of the next dose, skip the missed dose. Take||
1054|271|D|your next dose at the regular time. Do not double the dose to||
1054|272|D|catch up.||
1054|273|B|||
1054|274|R|STORAGE:  Store at room temperature away from light and moisture.||
1054|275|R|Do not store in the bathroom. Keep all medications away from||
1054|276|R|children and pets.||
1054|277|R|   Do not flush medications down the toilet or pour them into a||
1054|278|R|drain unless instructed to do so. Properly discard this product||
1054|279|R|when it is expired or no longer needed. Consult your pharmacist||
1054|280|R|or local waste disposal company.||
1054|281|B|||
1054|282|A|Information last revised August 2025.||
1054|283|A|Copyright(c) 2025 First Databank, Inc.||
1054|284|B|||
1055|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1055|002|Z|does NOT have all possible information about this product. This||
1055|003|Z|information does not assure that this product is safe, effective,||
1055|004|Z|or appropriate for you. This information is not individual||
1055|005|Z|medical advice and does not substitute for the advice of your||
1055|006|Z|health care professional. Always ask your health care||
1055|007|Z|professional for complete information about this product and your||
1055|008|Z|specific health needs.||
1055|009|B|||
1055|010|T|DICLOFENAC - TRANSDERMAL||
1055|011|F|(dye-KLOE-fen-ack)||
1055|012|B|||
1055|013|C|COMMON BRAND NAME(S): Flector, Licart||
1055|014|B|||
1055|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1055|016|W|diclofenac) may rarely increase the risk for a heart attack or||
1055|017|W|stroke. This effect can happen at any time while using this drug||
1055|018|W|but is more likely if you use it for a long time. The risk may be||
1055|019|W|greater in older adults or if you have heart disease or increased||
1055|020|W|risk for heart disease (for example, due to smoking, family||
1055|021|W|history of heart disease, or conditions such as high blood||
1055|022|W|pressure or diabetes). Do not use this drug right before or after||
1055|023|W|heart bypass surgery (CABG).||
1055|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
1055|025|W|bleeding from the stomach or intestines. This effect can occur||
1055|026|W|without warning symptoms at any time while using this drug. Older||
1055|027|W|adults may be at higher risk for this effect.||
1055|028|W|   Stop using diclofenac and get medical help right away if you||
1055|029|W|notice any of these rare but serious side effects:||
1055|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
1055|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1055|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
1055|033|W|side of the body, trouble speaking, sudden vision changes.||
1055|034|B|||
1055|035|U|USES:  Diclofenac patches are used to relieve pain from various||
1055|036|U|conditions (such as sprained ankle). This medication is known as||
1055|037|U|a nonsteroidal anti-inflammatory drug (NSAID).||
1055|038|U|   If you are treating a chronic condition such as arthritis, ask||
1055|039|U|your doctor about non-drug treatments and/or using other||
1055|040|U|medications to treat your pain. See also Warning section.||
1055|041|B|||
1055|042|H|HOW TO USE:  Read the Medication Guide provided by your||
1055|043|H|pharmacist before you start using diclofenac and each time you||
1055|044|H|get a refill. If you have any questions, consult your doctor or||
1055|045|H|pharmacist.||
1055|046|H|   The patch comes in a resealable envelope. When opening the||
1055|047|H|envelope for the first time, cut it open as instructed. Remove a||
1055|048|H|patch from the envelope and reseal the envelope. It is important||
1055|049|H|to reseal the envelope after each opening, or the remaining||
1055|050|H|patches will not stick correctly.||
1055|051|H|   Before applying the patch, remove the clear liner. Apply the||
1055|052|H|patch to the skin to cover the most painful area. Do not apply||
1055|053|H|the patch on burns, cuts, or irritated skin (such as eczema). Use||
1055|054|H|the patch as directed by your doctor. Depending on your product,||
1055|055|H|the patch is usually changed every 12 or 24 hours. Follow the||
1055|056|H|directions carefully. Fold the used patch in half with the sticky||
1055|057|H|sides together, and discard out of reach of children and pets.||
1055|058|H|   If the patch begins to peel off, you may tape the edges to the||
1055|059|H|skin.||
1055|060|H|   Do not wear the patch during bathing or showering. Take||
1055|061|H|baths/showers at times that you normally change the patch.||
1055|062|H|   To avoid getting the medication in your eyes, nose, mouth, or||
1055|063|H|vaginal area, wash your hands after handling the patch. If the||
1055|064|H|medication or patch does come in contact with those areas, flush||
1055|065|H|with plenty of water. Contact your doctor right away if||
1055|066|H|irritation lasts||
1055|067|H|   Dosage is based on your medical condition and response to||
1055|068|H|treatment. To reduce side effect risks (such as stomach||
1055|069|H|bleeding), use this medication at the lowest effective dose for||
1055|070|H|the shortest possible length of time. Do not increase your dose||
1055|071|H|or use it more often than prescribed. Discuss the risks and||
1055|072|H|benefits with your doctor or pharmacist.||
1055|073|H|   If you are using this drug "as needed" (not on a regular||
1055|074|H|schedule), remember that pain medications work best if they are||
1055|075|H|used as the first signs of pain occur. If you wait until the pain||
1055|076|H|has worsened, the medicine may not work as well.||
1055|077|H|   Tell your doctor if your pain lasts or gets worse.||
1055|078|B|||
1055|079|S|SIDE EFFECTS:  See also Warning section.||
1055|080|S|   Itching, burning, irritation, redness, or dry skin may occur||
1055|081|S|at the application site. If any of these effects last or get||
1055|082|S|worse, tell your doctor or pharmacist promptly.||
1055|083|S|   Remember that this medication has been prescribed because your||
1055|084|S|doctor has judged that the benefit to you is greater than the||
1055|085|S|risk of side effects. Many people using this medication do not||
1055|086|S|have serious side effects.||
1055|087|S|   This medication may raise your blood pressure. Check your||
1055|088|S|blood pressure regularly and tell your doctor if the results are||
1055|089|S|high.||
1055|090|S|   Tell your doctor right away if you have any serious side||
1055|091|S|effects, including: signs of kidney problems (such as change in||
1055|092|S|the amount of urine), symptoms of heart failure (such as swelling||
1055|093|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
1055|094|S|   This drug may rarely cause serious (possibly fatal) liver||
1055|095|S|problems. Get medical help right away if you have any symptoms of||
1055|096|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1055|097|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
1055|098|S|eyes/skin.||
1055|099|S|   A very serious allergic reaction to this drug is rare.||
1055|100|S|However, get medical help right away if you notice any symptoms||
1055|101|S|of a serious allergic reaction, including: fever, swollen lymph||
1055|102|S|nodes, rash, itching/swelling (especially of the||
1055|103|S|face/tongue/throat), severe dizziness, trouble breathing.||
1055|104|S|   This is not a complete list of possible side effects. If you||
1055|105|S|notice other effects not listed above, contact your doctor or||
1055|106|S|pharmacist.||
1055|107|S|   In the US -||
1055|108|S|   Call your doctor for medical advice about side effects. You||
1055|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1055|110|S|www.fda.gov/medwatch.||
1055|111|S|   In Canada - Call your doctor for medical advice about side||
1055|112|S|effects. You may report side effects to Health Canada at||
1055|113|S|1-866-234-2345.||
1055|114|B|||
1055|115|P|PRECAUTIONS:  Before using diclofenac, tell your doctor or||
1055|116|P|pharmacist if you are allergic to it; or to aspirin; or to other||
1055|117|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
1055|118|P|any other allergies. This product may contain inactive||
1055|119|P|ingredients, which can cause allergic reactions or other||
1055|120|P|problems. Talk to your pharmacist for more details.||
1055|121|P|   Before using this medication, tell your doctor or pharmacist||
1055|122|P|your medical history, especially of: asthma (including a history||
1055|123|P|of worsening breathing after taking aspirin or other NSAIDs),||
1055|124|P|stomach/intestine problems (such as bleeding, ulcers), liver||
1055|125|P|disease, heart disease (such as history of heart attack), high||
1055|126|P|blood pressure, stroke, swelling (edema, water retention), blood||
1055|127|P|disorders (such as anemia, bleeding/clotting problems), growths||
1055|128|P|in the nose (nasal polyps).||
1055|129|P|   Kidney problems can sometimes occur with the use of NSAID||
1055|130|P|medications, including diclofenac. Problems are more likely to||
1055|131|P|occur if you are dehydrated, have heart failure or kidney||
1055|132|P|disease, are an older adult, or if you take certain medications||
1055|133|P|(see also Drug Interactions section). Drink plenty of fluids as||
1055|134|P|directed by your doctor to prevent dehydration and tell your||
1055|135|P|doctor right away if you have a change in the amount of urine.||
1055|136|P|   Before having surgery, tell your doctor or dentist about all||
1055|137|P|the products you use (including prescription drugs,||
1055|138|P|nonprescription drugs, and herbal products).||
1055|139|P|   If you are going to have an MRI test, tell testing personnel||
1055|140|P|that you are using this patch. Some patches may contain metals||
1055|141|P|that can cause serious burns during an MRI. Ask your doctor||
1055|142|P|whether you will need to remove your patch before the test and||
1055|143|P|apply a new patch afterward, and how to do so properly.||
1055|144|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1055|145|P|and tobacco may increase your risk for stomach bleeding,||
1055|146|P|especially when combined with this medicine. Limit alcohol and||
1055|147|P|stop smoking. Consult your doctor or pharmacist for more||
1055|148|P|information.||
1055|149|P|   This medication may make you more sensitive to the sun. Limit||
1055|150|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1055|151|P|sunscreen and wear protective clothing when outdoors. Tell your||
1055|152|P|doctor right away if you get sunburned or have skin||
1055|153|P|blisters/redness.||
1055|154|P|   Older adults may be at greater risk for stomach/intestinal||
1055|155|P|bleeding, kidney problems, heart attack, and stroke while using||
1055|156|P|this drug.||
1055|157|P|   Before using this medication, women of childbearing age should||
1055|158|P|talk with their doctor(s) about the benefits and risks. Tell your||
1055|159|P|doctor if you are pregnant or if you plan to become pregnant.||
1055|160|P|This medication may harm an unborn baby and cause problems with||
1055|161|P|normal labor/delivery. It is not recommended for use in pregnancy||
1055|162|P|from 20 weeks until delivery. If your doctor decides that you||
1055|163|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1055|164|P|you should use the lowest effective dose for the shortest||
1055|165|P|possible time. You should not use this medication after 30 weeks||
1055|166|P|of pregnancy.||
1055|167|P|   This medication passes into breast milk, but is unlikely to||
1055|168|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1055|169|B|||
1055|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1055|171|I|medications work or increase your risk for serious side effects.||
1055|172|I|This document does not contain all possible drug interactions.||
1055|173|I|Keep a list of all the products you use (including||
1055|174|I|prescription/nonprescription drugs and herbal products) and share||
1055|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
1055|176|I|the dosage of any medicines without your doctor's approval.||
1055|177|I|   Some products that may interact with this drug include:||
1055|178|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1055|179|I|angiotensin II receptor blockers (such as losartan, valsartan),||
1055|180|I|cidofovir, corticosteroids (such as prednisone), lithium,||
1055|181|I|methotrexate, "water pills" (diuretics such as furosemide).||
1055|182|I|   This medication may increase the risk of bleeding when used||
1055|183|I|with other drugs that also may cause bleeding. Examples include||
1055|184|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1055|185|I|dabigatran/enoxaparin/warfarin, among others.||
1055|186|I|   Check all prescription and nonprescription medicine labels||
1055|187|I|carefully since many medications contain pain relievers/fever||
1055|188|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
1055|189|I|ketorolac). These drugs are similar to diclofenac and may||
1055|190|I|increase your risk of side effects if taken together. However, if||
1055|191|I|your doctor has told you to take low-dose aspirin to prevent||
1055|192|I|heart attack or stroke (usually 81-162 milligrams a day), you||
1055|193|I|should keep taking the aspirin unless your doctor tells you not||
1055|194|I|to. Ask your doctor or pharmacist for more details.||
1055|195|B|||
1055|196|O|OVERDOSE:  This medication patch may be harmful if chewed or||
1055|197|O|swallowed. If someone has overdosed, remove the patch if||
1055|198|O|possible. For serious symptoms such as passing out or trouble||
1055|199|O|breathing, call 911. Otherwise, call a poison control center||
1055|200|O|right away. US residents can call 1-800-222-1222. Canada||
1055|201|O|residents can call 1-844-764-7669.||
1055|202|B|||
1055|203|N|NOTES:  Do not share this medication with others.||
1055|204|N|   Lab and/or medical tests (such as blood pressure, complete||
1055|205|N|blood count, liver/kidney function) should be done while you are||
1055|206|N|using this medication. Keep all medical and lab appointments.||
1055|207|N|Consult your doctor for more details.||
1055|208|B|||
1055|209|D|MISSED DOSE:  If you are prescribed this drug on a regular||
1055|210|D|schedule (not just "as needed") and you miss a dose, use it as||
1055|211|D|soon as you remember. If it is near the time of the next dose,||
1055|212|D|skip the missed dose. Use your next dose at the regular time. Do||
1055|213|D|not double the dose to catch up.||
1055|214|B|||
1055|215|R|STORAGE:  Store patches in the envelope at room temperature.||
1055|216|R|Always reseal envelope after opening. The patches expire after a||
1055|217|R|certain amount of time after the envelope is first opened. Check||
1055|218|R|the product packaging for more details. Keep all medications away||
1055|219|R|from children and pets.||
1055|220|R|   Do not flush medications down the toilet or pour them into a||
1055|221|R|drain unless instructed to do so. Properly discard this product||
1055|222|R|when it is expired or no longer needed. Consult your pharmacist||
1055|223|R|or local waste disposal company.||
1055|224|B|||
1055|225|A|Information last revised May 2024.||
1055|226|A|Copyright(c) 2025 First Databank, Inc.||
1055|227|B|||
1056|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1056|002|Z|does NOT have all possible information about this product. This||
1056|003|Z|information does not assure that this product is safe, effective,||
1056|004|Z|or appropriate for you. This information is not individual||
1056|005|Z|medical advice and does not substitute for the advice of your||
1056|006|Z|health care professional. Always ask your health care||
1056|007|Z|professional for complete information about this product and your||
1056|008|Z|specific health needs.||
1056|009|B|||
1056|010|T|COAL TAR - TOPICAL||
1056|011|F|(kole-tar)||
1056|012|B|||
1056|013|C|COMMON BRAND NAME(S): Fototar, Scytera||
1056|014|B|||
1056|015|U|USES:  This medication is used on the skin to treat the itching,||
1056|016|U|scaling, and flaking due to skin conditions such as psoriasis or||
1056|017|U|seborrheic dermatitis. Coal tar belongs to a class of drugs known||
1056|018|U|as keratoplastics. It works by causing the skin to shed dead||
1056|019|U|cells from its top layer and slow down the growth of skin cells.||
1056|020|U|This effect decreases scaling and dryness. Coal tar can also||
1056|021|U|decrease itchiness from these skin conditions.||
1056|022|B|||
1056|023|V|OTHER USES:  This section contains uses of this product that are||
1056|024|V|not listed in the approved professional labeling for the product||
1056|025|V|but that may be prescribed by your health care professional. Use||
1056|026|V|this product for a condition that is listed in this section only||
1056|027|V|if it has been so prescribed by your health care professional.||
1056|028|V|   This product may also be used for other types of rashes (such||
1056|029|V|as eczema, atopic dermatitis, chronic exudative dermatitis).||
1056|030|B|||
1056|031|H|HOW TO USE:  Follow all directions on the product package. Check||
1056|032|H|the label to see if you need to shake the product before using.||
1056|033|H|If you have any questions, ask your doctor or pharmacist.||
1056|034|H|   This medication is for use on the skin only. To avoid||
1056|035|H|irritation, do not let this medication come into contact with||
1056|036|H|your eyes, nose, mouth, groin, or rectum. If you do get the||
1056|037|H|medication in those areas, flush the area with cool water for 15||
1056|038|H|minutes. Wash hands after use.||
1056|039|H|   Apply a small amount to the affected area. Massage in gently.||
1056|040|H|Apply usually 1 to 4 times a day or as directed by your doctor.||
1056|041|H|Allow to air dry before touching clothing. Do not apply to broken||
1056|042|H|or infected skin unless directed by your doctor.||
1056|043|H|   To treat the scalp, apply the solution according to the||
1056|044|H|package directions. Coal tar products may also be used in the||
1056|045|H|bath or as a hand/foot soak. Follow package directions carefully.||
1056|046|H|Rinse off well. Coal tar products can make the shower/bath very||
1056|047|H|slippery. Be careful not to fall.||
1056|048|H|   The dosage is based on your medical condition, product||
1056|049|H|type/brand, and response to treatment. Do not use large amounts||
1056|050|H|of this medication, use it more often, or use it for a longer||
1056|051|H|period than directed. Your condition will not clear faster, but||
1056|052|H|the chance for side effects may be increased.||
1056|053|H|   Some products contain alcohol and are flammable until dry.||
1056|054|H|Avoid smoking or being near open flames while using those||
1056|055|H|products and until the product has dried.||
1056|056|H|   Use this medication regularly to get the most benefit from it.||
1056|057|H|To help you remember, use it at the same time(s) each day.||
1056|058|H|   Tell your doctor if your condition lasts or gets worse. If||
1056|059|H|your skin condition covers a large area of skin, or if you think||
1056|060|H|you may have a serious medical problem, get medical help right||
1056|061|H|away.||
1056|062|B|||
1056|063|S|SIDE EFFECTS:  Skin/scalp irritation or staining of skin/hair||
1056|064|S|(especially in patients with blonde, bleached, dyed, or gray||
1056|065|S|hair) may occur. If skin irritation develops or worsens, stop||
1056|066|S|using this product and tell your doctor or pharmacist promptly.||
1056|067|S|   If your doctor has directed you to use this medication,||
1056|068|S|remember that your doctor has judged that the benefit to you is||
1056|069|S|greater than the risk of side effects. Many people using this||
1056|070|S|medication do not have serious side effects.||
1056|071|S|   Long-term use of this product can cause hair follicle problems||
1056|072|S|(tar acne). Contact your doctor if you notice new skin bumps||
1056|073|S|and/or acne in the treated area.||
1056|074|S|   A very serious allergic reaction to this drug is rare.||
1056|075|S|However, get medical help right away if you notice any symptoms||
1056|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1056|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1056|078|S|breathing.||
1056|079|S|   This is not a complete list of possible side effects. If you||
1056|080|S|notice other effects not listed above, contact your doctor or||
1056|081|S|pharmacist.||
1056|082|S|   In the US -||
1056|083|S|   Call your doctor for medical advice about side effects. You||
1056|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1056|085|S|www.fda.gov/medwatch.||
1056|086|S|   In Canada - Call your doctor for medical advice about side||
1056|087|S|effects. You may report side effects to Health Canada at||
1056|088|S|1-866-234-2345.||
1056|089|B|||
1056|090|P|PRECAUTIONS:  Before using coal tar, tell your doctor or||
1056|091|P|pharmacist if you are allergic to it; or if you have any other||
1056|092|P|allergies. This product may contain inactive ingredients, which||
1056|093|P|can cause allergic reactions or other problems. Talk to your||
1056|094|P|pharmacist for more details.||
1056|095|P|   Before using this medication, tell your doctor or pharmacist||
1056|096|P|your medical history.||
1056|097|P|   This medication may make you more sensitive to the sun. Be||
1056|098|P|sure to completely wash off the medication before light treatment||
1056|099|P|or going out into the sun as directed by your doctor. Avoid sun||
1056|100|P|exposure, tanning booths, and sunlamps for at least 24 hours||
1056|101|P|after using this medication unless your doctor directs you||
1056|102|P|otherwise. Other medications may also increase your sun||
1056|103|P|sensitivity. Ask your doctor or pharmacist for more details. Tell||
1056|104|P|your doctor right away if you get sunburned or have skin||
1056|105|P|blisters/redness.||
1056|106|P|   Before having surgery, tell your doctor or dentist about all||
1056|107|P|the products you use (including prescription drugs,||
1056|108|P|nonprescription drugs, and herbal products).||
1056|109|P|   During pregnancy, this medication should be used only when||
1056|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
1056|111|P|   It is unknown if this drug passes into breast milk. Consult||
1056|112|P|your doctor before breastfeeding.||
1056|113|B|||
1056|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1056|115|I|medications work or increase your risk for serious side effects.||
1056|116|I|This document does not contain all possible drug interactions.||
1056|117|I|Keep a list of all the products you use (including||
1056|118|I|prescription/nonprescription drugs and herbal products) and share||
1056|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
1056|120|I|the dosage of any medicines without your doctor's approval.||
1056|121|B|||
1056|122|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1056|123|O|has overdosed and has serious symptoms such as passing out or||
1056|124|O|trouble breathing, call 911. Otherwise, call a poison control||
1056|125|O|center right away. US residents can call 1-800-222-1222. Canada||
1056|126|O|residents can call 1-844-764-7669.||
1056|127|B|||
1056|128|N|NOTES:  This product may stain clothing. Avoid allowing this||
1056|129|N|medication to touch clothing before it dries.||
1056|130|N|   If your doctor has prescribed this medication for you, do not||
1056|131|N|share it with others.||
1056|132|B|||
1056|133|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1056|134|D|If it is near the time of the next dose, skip the missed dose.||
1056|135|D|Use your next dose at the regular time. Do not double the dose to||
1056|136|D|catch up.||
1056|137|B|||
1056|138|R|STORAGE:  Store at room temperature. Different brands of this||
1056|139|R|medication may have different storage requirements. Refer to the||
1056|140|R|package labeling or ask your pharmacist for the storage||
1056|141|R|requirements for the brand you are using. Some products may||
1056|142|R|contain alcohol and are flammable. Keep those products away from||
1056|143|R|heat and open flame. Keep all medications away from children and||
1056|144|R|pets.||
1056|145|R|   Do not flush medications down the toilet or pour them into a||
1056|146|R|drain unless instructed to do so. Properly discard this product||
1056|147|R|when it is expired or no longer needed. Consult your pharmacist||
1056|148|R|or local waste disposal company.||
1056|149|B|||
1056|150|A|Information last revised November 2025.||
1056|151|A|Copyright(c) 2025 First Databank, Inc.||
1056|152|B|||
1057|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1057|002|Z|does NOT have all possible information about this product. This||
1057|003|Z|information does not assure that this product is safe, effective,||
1057|004|Z|or appropriate for you. This information is not individual||
1057|005|Z|medical advice and does not substitute for the advice of your||
1057|006|Z|health care professional. Always ask your health care||
1057|007|Z|professional for complete information about this product and your||
1057|008|Z|specific health needs.||
1057|009|B|||
1057|010|T|PHENYTOIN SUSPENSION - ORAL||
1057|011|F|(FEN-i-toyn)||
1057|012|B|||
1057|013|C|COMMON BRAND NAME(S): Dilantin||
1057|014|B|||
1057|015|U|USES:  Phenytoin is used to prevent and control seizures (also||
1057|016|U|called an anticonvulsant or antiepileptic drug). It works by||
1057|017|U|reducing the spread of seizure activity in the brain.||
1057|018|B|||
1057|019|V|OTHER USES:  This section contains uses of this drug that are not||
1057|020|V|listed in the approved professional labeling for the drug but||
1057|021|V|that may be prescribed by your health care professional. Use this||
1057|022|V|drug for a condition that is listed in this section only if it||
1057|023|V|has been so prescribed by your health care professional.||
1057|024|V|   This drug may also be used for certain types of irregular||
1057|025|V|heartbeats.||
1057|026|B|||
1057|027|H|HOW TO USE:  Read the Medication Guide provided by your||
1057|028|H|pharmacist before you start taking phenytoin and each time you||
1057|029|H|get a refill. If you have any questions, ask your doctor or||
1057|030|H|pharmacist.||
1057|031|H|   Shake this medication well before each dose. Take this||
1057|032|H|medication by mouth as directed by your doctor, usually 2 or 3||
1057|033|H|times a day. This product is not recommended for use once a day.||
1057|034|H|You may take it with food if stomach upset occurs.||
1057|035|H|   Carefully measure the dose using a special measuring||
1057|036|H|device/spoon/syringe. Do not use a household spoon because you||
1057|037|H|may not get the correct dose.||
1057|038|H|   Use this medication regularly in order to get the most benefit||
1057|039|H|from it. It is important to take all doses on time to keep the||
1057|040|H|amount of medicine in your body at a constant level. Remember to||
1057|041|H|use it at the same times each day. The dosage is based on your||
1057|042|H|medical condition, lab tests, and response to treatment.||
1057|043|H|Children's dosage is also based on weight.||
1057|044|H|   Antacids and nutritional tube-feeding (enteral) products may||
1057|045|H|decrease the absorption of phenytoin. Do not take these products||
1057|046|H|at the same time as your phenytoin dose. Separate liquid||
1057|047|H|nutritional products at least 1 hour before and 1 hour after your||
1057|048|H|phenytoin dose, or as directed by your doctor.||
1057|049|H|   Do not stop taking this medication without consulting your||
1057|050|H|doctor. Seizures may become worse when the drug is suddenly||
1057|051|H|stopped. Your dose may need to be gradually decreased.||
1057|052|H|   Tell your doctor if your condition does not get better or if||
1057|053|H|it gets worse.||
1057|054|B|||
1057|055|S|SIDE EFFECTS:  Headache, nausea, vomiting, constipation,||
1057|056|S|dizziness, feeling of spinning, drowsiness, trouble sleeping, or||
1057|057|S|nervousness may occur. If any of these effects last or get worse,||
1057|058|S|tell your doctor or pharmacist promptly.||
1057|059|S|   Phenytoin may cause swelling and bleeding of the gums. Massage||
1057|060|S|your gums and brush and floss your teeth regularly to minimize||
1057|061|S|this problem. See your dentist regularly.||
1057|062|S|   Remember that this medication has been prescribed because your||
1057|063|S|doctor has judged that the benefit to you is greater than the||
1057|064|S|risk of side effects. Many people using this medication do not||
1057|065|S|have serious side effects.||
1057|066|S|   Tell your doctor right away if you have any serious side||
1057|067|S|effects, including: slow heartbeat, unusual eye movements, loss||
1057|068|S|of coordination, trouble speaking, confusion, muscle twitching,||
1057|069|S|double/blurred vision, tingling of the hands/feet, facial changes||
1057|070|S|(such as swollen lips, butterfly-shaped rash around the||
1057|071|S|nose/cheeks), excessive hair growth, increased thirst/urination,||
1057|072|S|unusual tiredness, bone/joint pain, easily broken bones.||
1057|073|S|   A small number of people who take anticonvulsants for any||
1057|074|S|condition (such as seizure, bipolar disorder, pain) may||
1057|075|S|experience depression, suicidal thoughts/attempts, or other||
1057|076|S|mental/mood problems. Tell your doctor right away if you or your||
1057|077|S|family/caregiver notice any unusual/sudden changes in your mood,||
1057|078|S|thoughts, or behavior including signs of depression, suicidal||
1057|079|S|thoughts/attempts, thoughts about harming yourself.||
1057|080|S|   Rarely, males may have a painful or prolonged erection lasting||
1057|081|S|4 or more hours. If this occurs, stop using this drug and get||
1057|082|S|medical help right away, or permanent problems could occur.||
1057|083|S|   Get medical help right away if you have any very serious side||
1057|084|S|effects, including: uncontrolled muscle movements, signs of liver||
1057|085|S|problems (such as nausea/vomiting that doesn't stop,||
1057|086|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
1057|087|S|bruising/bleeding.||
1057|088|S|   A very serious allergic reaction to this drug is rare.||
1057|089|S|However, get medical help right away if you notice any symptoms||
1057|090|S|of a serious allergic reaction, including: fever, swollen lymph||
1057|091|S|nodes, rash, itching/swelling (especially of the||
1057|092|S|face/tongue/throat), severe dizziness, trouble breathing.||
1057|093|S|   This is not a complete list of possible side effects. If you||
1057|094|S|notice other effects not listed above, contact your doctor or||
1057|095|S|pharmacist.||
1057|096|S|   In the US -||
1057|097|S|   Call your doctor for medical advice about side effects. You||
1057|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1057|099|S|www.fda.gov/medwatch.||
1057|100|S|   In Canada - Call your doctor for medical advice about side||
1057|101|S|effects. You may report side effects to Health Canada at||
1057|102|S|1-866-234-2345.||
1057|103|B|||
1057|104|P|PRECAUTIONS:  Before taking phenytoin, tell your doctor or||
1057|105|P|pharmacist if you are allergic to it; or to other anti-seizure||
1057|106|P|medications (such as carbamazepine, ethosuximide, ethotoin,||
1057|107|P|fosphenytoin, oxcarbazepine, phenobarbital, primidone,||
1057|108|P|trimethadione); or if you have any other allergies. This product||
1057|109|P|may contain inactive ingredients, which can cause allergic||
1057|110|P|reactions or other problems. Talk to your pharmacist for more||
1057|111|P|details.||
1057|112|P|   Before using this medication, tell your doctor or pharmacist||
1057|113|P|your medical history, especially of: alcohol use, certain blood||
1057|114|P|conditions (porphyria), diabetes, liver disease (including liver||
1057|115|P|disease caused by past phenytoin use), lupus, folate or vitamin||
1057|116|P|B-12 deficiency (megaloblastic anemia).||
1057|117|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1057|118|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1057|119|P|machinery, or do anything that needs alertness until you can do||
1057|120|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1057|121|P|are using marijuana (cannabis). Alcohol may also affect your||
1057|122|P|blood levels of this drug.||
1057|123|P|   Before having surgery, tell your doctor or dentist about all||
1057|124|P|the products you use (including prescription drugs,||
1057|125|P|nonprescription drugs, and herbal products).||
1057|126|P|   If you have diabetes, this product may make it harder to||
1057|127|P|control your blood sugar. Check your blood sugar regularly as||
1057|128|P|directed and share the results with your doctor. Your doctor may||
1057|129|P|need to adjust your diabetes medication, exercise program, or||
1057|130|P|diet.||
1057|131|P|   Vitamin D supplements may be necessary to prevent weakening of||
1057|132|P|the bones (osteomalacia). Discuss this with your doctor.||
1057|133|P|   During pregnancy, this medication should be used only when||
1057|134|P|clearly needed. It may harm an unborn baby. However, since||
1057|135|P|untreated seizures are a serious condition that can harm both a||
1057|136|P|pregnant woman and her unborn baby, do not stop taking this||
1057|137|P|medication unless directed by your doctor. If you are planning||
1057|138|P|pregnancy, become pregnant, or think you may be pregnant,||
1057|139|P|immediately talk to your doctor about the benefits and risks of||
1057|140|P|using this medication during pregnancy. Since birth control||
1057|141|P|pills, patches, implants, and injections may not work if taken||
1057|142|P|with this medication (see also Drug Interactions section),||
1057|143|P|discuss reliable forms of birth control with your doctor.||
1057|144|P|   Phenytoin passes into breast milk. Consult your doctor before||
1057|145|P|breastfeeding.||
1057|146|B|||
1057|147|I|DRUG INTERACTIONS:  See also How to Use section.||
1057|148|I|   Drug interactions may change how your medications work or||
1057|149|I|increase your risk for serious side effects. This document does||
1057|150|I|not contain all possible drug interactions. Keep a list of all||
1057|151|I|the products you use (including prescription/nonprescription||
1057|152|I|drugs and herbal products) and share it with your doctor and||
1057|153|I|pharmacist. Do not start, stop, or change the dosage of any||
1057|154|I|medicines without your doctor's approval.||
1057|155|I|   Some products that may interact with this drug include:||
1057|156|I|colesevelam, orlistat, sucralfate.||
1057|157|I|   Other medications can affect the removal of phenytoin from||
1057|158|I|your body, which may affect how phenytoin works. Examples include||
1057|159|I|amiodarone, azapropazone, azole antifungals (such as||
1057|160|I|itraconazole), macrolide antibiotics (such as erythromycin),||
1057|161|I|estrogens, isoniazid, rifamycins (such as rifabutin), St. John's||
1057|162|I|wort, among others.||
1057|163|I|   Phenytoin can speed up the removal of other medications from||
1057|164|I|your body, which may affect how they work. Examples of affected||
1057|165|I|drugs include atazanavir, some drugs to treat cancer (such as||
1057|166|I|imatinib, irinotecan), cobicistat, corticosteroids (such as||
1057|167|I|prednisone), doravirine, etravirine, felodipine, nisoldipine,||
1057|168|I|quetiapine, quinidine, rilpivirine, suvorexant, telithromycin,||
1057|169|I|theophylline, vitamin D, among others.||
1057|170|I|   This medication may decrease the effectiveness of hormonal||
1057|171|I|birth control such as pills, patch, or ring. This could cause||
1057|172|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1057|173|I|use reliable backup birth control methods while using this||
1057|174|I|medication. Also tell your doctor if you have any new spotting or||
1057|175|I|breakthrough bleeding, because these may be signs that your birth||
1057|176|I|control is not working well.||
1057|177|I|   This medication may interfere with certain lab tests, possibly||
1057|178|I|causing false test results. Make sure lab personnel and all your||
1057|179|I|doctors know you use this drug.||
1057|180|B|||
1057|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1057|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1057|183|O|poison control center right away. US residents can call||
1057|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1057|185|O|Symptoms of overdose may include: severe mental/mood changes,||
1057|186|O|severe drowsiness, loss of consciousness, slowed breathing.||
1057|187|B|||
1057|188|N|NOTES:  Do not share this medication with others.||
1057|189|N|   Lab and/or medical tests (such as phenytoin blood levels,||
1057|190|N|liver function, complete blood count) should be done while you||
1057|191|N|are taking this medication. Keep all medical and lab||
1057|192|N|appointments. Consult your doctor for more details.||
1057|193|N|   Do not change from one brand of this product to another, or to||
1057|194|N|another dose form of this drug (such as capsules) without||
1057|195|N|consulting your doctor or pharmacist. Your dosage may have to be||
1057|196|N|adjusted.||
1057|197|B|||
1057|198|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1057|199|D|remember. If it is within 4 hours of the next dose, skip the||
1057|200|D|missed dose. Take your next dose at the regular time. Do not||
1057|201|D|double the dose to catch up. Check with your doctor if you miss||
1057|202|D|doses for more than 2 days in a row.||
1057|203|B|||
1057|204|R|STORAGE:  Store at room temperature away from light and moisture.||
1057|205|R|Do not freeze. Do not store in the bathroom. Keep all medications||
1057|206|R|away from children and pets.||
1057|207|R|   Do not flush medications down the toilet or pour them into a||
1057|208|R|drain unless instructed to do so. Properly discard this product||
1057|209|R|when it is expired or no longer needed. Consult your pharmacist||
1057|210|R|or local waste disposal company.||
1057|211|B|||
1057|212|M|MEDICAL ALERT:  Your condition can cause complications in a||
1057|213|M|medical emergency. For information about enrolling in MedicAlert,||
1057|214|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1057|215|B|||
1057|216|A|Information last revised October 2024.||
1057|217|A|Copyright(c) 2025 First Databank, Inc.||
1057|218|B|||
1060|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1060|002|Z|does NOT have all possible information about this product. This||
1060|003|Z|information does not assure that this product is safe, effective,||
1060|004|Z|or appropriate for you. This information is not individual||
1060|005|Z|medical advice and does not substitute for the advice of your||
1060|006|Z|health care professional. Always ask your health care||
1060|007|Z|professional for complete information about this product and your||
1060|008|Z|specific health needs.||
1060|009|B|||
1060|010|T|OPIOID ANTITUSSIVE/ANTIHISTAMINE/ACETAMINOPHEN - ORAL||
1060|011|B|||
1060|012|W|WARNING:  This medication has a risk for abuse and addiction,||
1060|013|W|which can lead to overdose and death. This medication may also||
1060|014|W|cause severe, possibly fatal, breathing problems. To lower your||
1060|015|W|risk, your doctor should have you take the smallest dose that||
1060|016|W|works, and take it for the shortest possible time. See also How||
1060|017|W|to Use section for more information about addiction.||
1060|018|W|   The risk for severe breathing problems is higher when you||
1060|019|W|start this medication, or if you take the wrong dose or take more||
1060|020|W|of this medication than prescribed. Taking this medication with||
1060|021|W|alcohol or other drugs that can cause drowsiness or breathing||
1060|022|W|problems may cause very serious side effects, including death.||
1060|023|W|Also, other medications can affect the removal of this product||
1060|024|W|from your body, which may affect how it works. Be sure you know||
1060|025|W|how to take this product and what other drugs you should avoid||
1060|026|W|taking with it. See also Drug Interactions section. Get medical||
1060|027|W|help right away if any of these very serious side effects occur:||
1060|028|W|slow/shallow breathing, unusual lightheadedness, severe||
1060|029|W|drowsiness/dizziness, difficulty waking up.||
1060|030|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1060|031|W|or abuse. If someone accidentally swallows this drug, get medical||
1060|032|W|help right away.||
1060|033|W|   Before using this medication, women of childbearing age should||
1060|034|W|talk with their doctor(s) about the risks and benefits. Tell your||
1060|035|W|doctor if you are pregnant or think you may be pregnant. During||
1060|036|W|pregnancy, this medication is not recommended. It may slightly||
1060|037|W|increase the risk of birth defects if used during the first two||
1060|038|W|months of pregnancy. Also, using it for a long time or in high||
1060|039|W|doses near the expected delivery date may harm the unborn baby.||
1060|040|W|To lessen the risk, take the smallest effective dose for the||
1060|041|W|shortest possible time. Babies born to mothers who use this drug||
1060|042|W|for a long time may develop severe (possibly fatal) withdrawal||
1060|043|W|symptoms. Tell the doctor right away if you notice any symptoms||
1060|044|W|in your newborn baby such as crying that doesn't stop,||
1060|045|W|slow/shallow breathing, irritability, shaking, vomiting,||
1060|046|W|diarrhea, poor feeding, or difficulty gaining weight.||
1060|047|W|   One ingredient in this product is acetaminophen. Taking too||
1060|048|W|much acetaminophen may cause serious (possibly fatal) liver||
1060|049|W|disease. Adults should not take more than 4000 milligrams (4||
1060|050|W|grams) of acetaminophen a day. People with liver problems and||
1060|051|W|children should take less acetaminophen. Ask your doctor or||
1060|052|W|pharmacist how much acetaminophen is safe to take.||
1060|053|W|   Do not use with any other drug containing acetaminophen||
1060|054|W|without asking your doctor or pharmacist first. Acetaminophen is||
1060|055|W|in many nonprescription and prescription medications (such as||
1060|056|W|pain/fever drugs or cough-and-cold products). Check the labels on||
1060|057|W|all your medicines to see if they contain acetaminophen, and ask||
1060|058|W|your pharmacist if you are unsure.||
1060|059|W|   Get medical help right away if you take too much acetaminophen||
1060|060|W|(overdose), even if you feel well. Overdose symptoms may include||
1060|061|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
1060|062|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
1060|063|W|   Daily alcohol use, especially when combined with||
1060|064|W|acetaminophen, may damage your liver. Avoid alcohol.||
1060|065|B|||
1060|066|U|USES:  This combination product is used to treat symptoms caused||
1060|067|U|by the common cold, flu, allergies, hay fever, or other breathing||
1060|068|U|illnesses (such as sinusitis, bronchitis). This product contains||
1060|069|U|an opioid cough suppressant (antitussive) that affects a certain||
1060|070|U|part of the brain, reducing the urge to cough. Antihistamines||
1060|071|U|relieve watery eyes, itchy eyes/nose/throat, runny nose, and||
1060|072|U|sneezing. Acetaminophen is a non-aspirin pain reliever and fever||
1060|073|U|reducer.||
1060|074|U|   Opioid cough suppressants should not be used by children||
1060|075|U|younger than 18 years. Children are at higher risk for serious||
1060|076|U|(even fatal) side effects, especially breathing problems. Talk||
1060|077|U|with the doctor about the risks and benefits of this medication.||
1060|078|U|   Cough-and-cold products do not cure colds. Cough due to a||
1060|079|U|common cold often does not need to be treated with medicine. Ask||
1060|080|U|your doctor or pharmacist about other ways to relieve cough and||
1060|081|U|cold symptoms, such as drinking enough fluids, using a||
1060|082|U|humidifier, or saline nose drops/spray.||
1060|083|B|||
1060|084|H|HOW TO USE:  See also Warning section.||
1060|085|H|   Take this medication by mouth with or without food as directed||
1060|086|H|by your doctor, usually every 4 to 6 hours as needed. This||
1060|087|H|medication may be taken with food or milk if stomach upset||
1060|088|H|occurs. The dosage is based on your medical condition and||
1060|089|H|response to treatment.||
1060|090|H|   Do not increase your dose or use this product more often or||
1060|091|H|for longer than prescribed. Your condition will not improve any||
1060|092|H|faster, and your risk of side effects will increase.||
1060|093|H|   If you suddenly stop using this medication, you may have||
1060|094|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
1060|095|H|nose, nausea, sweating, muscle aches). To help prevent||
1060|096|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1060|097|H|more likely if you have used this medication regularly for a long||
1060|098|H|time (more than a few weeks) or in high doses. Tell your doctor||
1060|099|H|or pharmacist right away if you have withdrawal.||
1060|100|H|   Though it helps many people, this product may sometimes cause||
1060|101|H|addiction. This risk may be higher if you have a mental/mood||
1060|102|H|disorder or a substance use disorder (such as overuse of or||
1060|103|H|addiction to drugs/alcohol). Take this product exactly as||
1060|104|H|prescribed to lower the risk of addiction. Ask your doctor or||
1060|105|H|pharmacist for more details.||
1060|106|H|   When used for an extended time, this medication may not work||
1060|107|H|as well and may require different dosing. Talk with your doctor||
1060|108|H|if this medication stops working well.||
1060|109|H|   Tell your doctor if your cough does not get better in 5 days.||
1060|110|H|Also, tell your doctor if your condition gets worse, or if you||
1060|111|H|have a headache that doesn't go away, fever, or rash. These may||
1060|112|H|be symptoms of a serious medical problem and should be checked by||
1060|113|H|a doctor.||
1060|114|B|||
1060|115|S|SIDE EFFECTS:  See also Warning section.||
1060|116|S|   Drowsiness, dizziness, headache, blurred vision, upset||
1060|117|S|stomach, nausea, constipation, or dry mouth/nose/throat may||
1060|118|S|occur. If any of these effects last or get worse, tell your||
1060|119|S|doctor or pharmacist promptly.||
1060|120|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
1060|121|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1060|122|S|substitute. This medication can dry up and thicken mucus in your||
1060|123|S|lungs, making it more difficult to breathe and clear your lungs.||
1060|124|S|To help prevent this effect, drink plenty of fluids unless||
1060|125|S|otherwise directed by your doctor.||
1060|126|S|   To reduce the risk of dizziness and lightheadedness, get up||
1060|127|S|slowly when rising from a sitting or lying position.||
1060|128|S|   Remember that this medication has been prescribed because your||
1060|129|S|doctor has judged that the benefit to you is greater than the||
1060|130|S|risk of side effects. Many people using this medication do not||
1060|131|S|have serious side effects.||
1060|132|S|   Tell your doctor right away if you have any serious side||
1060|133|S|effects, including: interrupted breathing during sleep (sleep||
1060|134|S|apnea), mental/mood changes (such as hallucinations), ringing in||
1060|135|S|the ears, trouble urinating, easy bruising/bleeding,||
1060|136|S|fast/slow/irregular heartbeat, trouble swallowing.||
1060|137|S|   Get medical help right away if you have any very serious side||
1060|138|S|effects, including: seizure.||
1060|139|S|   This product may cause serious mental/mood changes and very||
1060|140|S|serious (rarely fatal) breathing problems. This product may||
1060|141|S|contain codeine or dihydrocodeine. Codeine and dihydrocodeine are||
1060|142|S|changed into strong opioid drugs (morphine or dihydromorphine) in||
1060|143|S|your body. In some people this happens faster and more completely||
1060|144|S|than usual, which increases the risk of very serious side||
1060|145|S|effects. Get medical help right away if you notice any of the||
1060|146|S|following: slow/shallow breathing, severe drowsiness/difficulty||
1060|147|S|waking up, confusion.||
1060|148|S|   A very serious allergic reaction to this drug is rare.||
1060|149|S|However, get medical help right away if you notice any symptoms||
1060|150|S|of a serious allergic reaction, including: rash, itching/swelling||
1060|151|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1060|152|S|breathing.||
1060|153|S|   This is not a complete list of possible side effects. If you||
1060|154|S|notice other effects not listed above, contact your doctor or||
1060|155|S|pharmacist.||
1060|156|S|   In the US -||
1060|157|S|   Call your doctor for medical advice about side effects. You||
1060|158|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1060|159|S|www.fda.gov/medwatch.||
1060|160|S|   In Canada - Call your doctor for medical advice about side||
1060|161|S|effects. You may report side effects to Health Canada at||
1060|162|S|1-866-234-2345.||
1060|163|B|||
1060|164|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1060|165|P|pharmacist if you are allergic to any of its ingredients; or if||
1060|166|P|you have any other allergies. This product may contain inactive||
1060|167|P|ingredients, which can cause allergic reactions or other||
1060|168|P|problems. Talk to your pharmacist for more details.||
1060|169|P|   Before using this medication, tell your doctor or pharmacist||
1060|170|P|your medical history, especially of: abdominal problems (such as||
1060|171|P|chronic constipation, ileus, gallbladder disease, pancreatitis),||
1060|172|P|adrenal gland problem (such as Addison's disease), certain brain||
1060|173|P|disorders (such as head injury, tumor, increased intracranial||
1060|174|P|pressure), breathing problems (such as asthma, emphysema, sleep||
1060|175|P|apnea), diabetes, glaucoma, heart problems, high blood pressure,||
1060|176|P|kidney problems, liver disease, mental/mood problems (such as||
1060|177|P|depression, psychosis), seizures, stomach/intestinal problems||
1060|178|P|(such as ulcers, blockage), underactive thyroid (hypothyroidism),||
1060|179|P|urination problems (such as trouble urinating due to enlarged||
1060|180|P|prostate, urinary retention), personal or family history of a||
1060|181|P|substance use disorder (such as overuse of or addiction to||
1060|182|P|drugs/alcohol), obesity.||
1060|183|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1060|184|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1060|185|P|machinery, or do anything that needs alertness until you can do||
1060|186|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1060|187|P|are using marijuana (cannabis).||
1060|188|P|   Before having surgery, tell your doctor or dentist about all||
1060|189|P|the products you use (including prescription drugs,||
1060|190|P|nonprescription drugs, and herbal products).||
1060|191|P|   Older adults may be more sensitive to the side effects of this||
1060|192|P|drug, especially confusion, dizziness, drowsiness, and||
1060|193|P|slow/shallow breathing.||
1060|194|P|   Tell your doctor if you are pregnant or think you may be||
1060|195|P|pregnant. During pregnancy, this product is not recommended. It||
1060|196|P|may harm an unborn baby. Talk to your doctor about the risks and||
1060|197|P|benefits of this medication. See also Warning section.||
1060|198|P|   This product may pass into breast milk and may have||
1060|199|P|undesirable effects on a nursing infant (such as unusual||
1060|200|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
1060|201|P|limpness). Consult your doctor before breastfeeding.||
1060|202|B|||
1060|203|I|DRUG INTERACTIONS:  See also Warning section.||
1060|204|I|   Drug interactions may change how your medications work or||
1060|205|I|increase your risk for serious side effects. This document does||
1060|206|I|not contain all possible drug interactions. Keep a list of all||
1060|207|I|the products you use (including prescription/nonprescription||
1060|208|I|drugs and herbal products) and share it with your doctor and||
1060|209|I|pharmacist. Do not start, stop, or change the dosage of any||
1060|210|I|medicines without your doctor's approval.||
1060|211|I|   Some products that may interact with this drug include:||
1060|212|I|antihistamines applied to the skin (such as diphenhydramine||
1060|213|I|cream, ointment, spray), naltrexone, samidorphan.||
1060|214|I|   The ingredients in this product are available in many||
1060|215|I|prescription and nonprescription products. Check the labels on||
1060|216|I|all your medications carefully to make sure you are not taking||
1060|217|I|more than one product with the same ingredient(s). Consult your||
1060|218|I|pharmacist if you are unsure about the ingredients in any of your||
1060|219|I|medications.||
1060|220|I|   The risk of serious side effects (such as slow/shallow||
1060|221|I|breathing, severe drowsiness/dizziness) may be increased if this||
1060|222|I|medication is taken with other products that may also cause||
1060|223|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1060|224|I|if you are taking other products such as other opioid pain or||
1060|225|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1060|226|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1060|227|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1060|228|I|carisoprodol, cyclobenzaprine), or other antihistamines (such as||
1060|229|I|cetirizine, diphenhydramine).||
1060|230|I|   Check the labels on all your medicines (such as allergy or||
1060|231|I|cough-and-cold products) because they may contain ingredients||
1060|232|I|that cause drowsiness. Ask your pharmacist about using those||
1060|233|I|products safely.||
1060|234|I|   Other medications can affect the removal of this product from||
1060|235|I|your body, which may affect how this product works. Examples||
1060|236|I|include azole antifungals (such as ketoconazole), bupropion,||
1060|237|I|fluoxetine, macrolide antibiotics (such as erythromycin),||
1060|238|I|levoketoconazole, paroxetine, quinidine, rifamycins (such as||
1060|239|I|rifabutin, rifampin), ritonavir, certain drugs used to treat||
1060|240|I|seizures (such as carbamazepine, phenytoin), among others.||
1060|241|I|   This medication may interfere with certain lab tests (such as||
1060|242|I|amylase/lipase levels, urine drug screening tests, allergy skin||
1060|243|I|test), possibly causing false test results. Make sure lab||
1060|244|I|personnel and all your doctors know you use this drug.||
1060|245|B|||
1060|246|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1060|247|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1060|248|O|poison control center right away. US residents can call||
1060|249|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1060|250|O|Symptoms of overdose may include: severe drowsiness, slow/shallow||
1060|251|O|breathing, nausea, vomiting, loss of appetite, sweating,||
1060|252|O|stomach/abdominal pain, extreme tiredness, yellowing eyes/skin,||
1060|253|O|dark urine, confusion, cold/clammy skin, fast/slow/irregular||
1060|254|O|heartbeat, seizures, coma.||
1060|255|B|||
1060|256|N|NOTES:  Do not share this medication with others. Sharing it is||
1060|257|N|against the law.||
1060|258|B|||
1060|259|D|MISSED DOSE:  If you are prescribed this medication on a regular||
1060|260|D|schedule and miss a dose, take it as soon as you remember. If it||
1060|261|D|is near the time of the next dose, skip the missed dose. Take||
1060|262|D|your next dose at the regular time. Do not double the dose to||
1060|263|D|catch up.||
1060|264|B|||
1060|265|R|STORAGE:  Store at room temperature away from light and moisture.||
1060|266|R|Do not store in the bathroom. Keep all medications away from||
1060|267|R|children and pets.||
1060|268|R|   Do not flush medications down the toilet or pour them into a||
1060|269|R|drain unless instructed to do so. Properly discard this product||
1060|270|R|when it is expired or no longer needed. Consult your pharmacist||
1060|271|R|or local waste disposal company.||
1060|272|B|||
1060|273|A|Information last revised August 2025.||
1060|274|A|Copyright(c) 2025 First Databank, Inc.||
1060|275|B|||
1061|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1061|002|Z|does NOT have all possible information about this product. This||
1061|003|Z|information does not assure that this product is safe, effective,||
1061|004|Z|or appropriate for you. This information is not individual||
1061|005|Z|medical advice and does not substitute for the advice of your||
1061|006|Z|health care professional. Always ask your health care||
1061|007|Z|professional for complete information about this product and your||
1061|008|Z|specific health needs.||
1061|009|B|||
1061|010|T|MIGLITOL - ORAL||
1061|011|F|(MIG-li-tol)||
1061|012|B|||
1061|013|C|COMMON BRAND NAME(S): Glyset||
1061|014|B|||
1061|015|U|USES:  Miglitol is used with a proper diet and exercise program||
1061|016|U|to control high blood sugar in people with type 2 diabetes.||
1061|017|U|Controlling high blood sugar helps prevent kidney damage,||
1061|018|U|blindness, nerve problems, loss of limbs, and sexual function||
1061|019|U|problems. Proper control of diabetes may also lessen your risk of||
1061|020|U|a heart attack or stroke. Miglitol works in your intestines to||
1061|021|U|slow the breakdown and absorption of carbohydrates from foods||
1061|022|U|that you eat. This effect helps lessen your blood sugar rise||
1061|023|U|after a meal.||
1061|024|B|||
1061|025|H|HOW TO USE:  Take this medication by mouth as directed by your||
1061|026|H|doctor, usually 3 times daily with the first bite of a meal. The||
1061|027|H|dosage is based on your medical condition and response to||
1061|028|H|treatment.||
1061|029|H|   Use this medication regularly to get the most benefit from it.||
1061|030|H|To help you remember, take it at the same times each day.||
1061|031|H|   Tell your doctor if your condition does not get better or if||
1061|032|H|it gets worse (your blood sugar is too high or too low).||
1061|033|B|||
1061|034|S|SIDE EFFECTS:  Diarrhea, gas, or abdominal discomfort/pain may||
1061|035|S|occur as your body adjusts to this medication during the first||
1061|036|S|few weeks. These side effects usually lessen with time. If any of||
1061|037|S|these effects last or get worse, tell your doctor or pharmacist||
1061|038|S|promptly.||
1061|039|S|   Remember that this medication has been prescribed because your||
1061|040|S|doctor has judged that the benefit to you is greater than the||
1061|041|S|risk of side effects. Many people using this medication do not||
1061|042|S|have serious side effects.||
1061|043|S|   Miglitol does not usually cause low blood sugar||
1061|044|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1061|045|S|prescribed with other diabetes medications, or if you do not get||
1061|046|S|enough calories from food, or if you do unusually heavy exercise.||
1061|047|S|Talk with your doctor or pharmacist about whether the dose of||
1061|048|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1061|049|S|of low blood sugar include sudden sweating, shaking, fast||
1061|050|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1061|051|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1061|052|S|treat low blood sugar. If you don't have these reliable forms of||
1061|053|S|glucose, rapidly raise your blood sugar by eating some honey or||
1061|054|S|drinking a glass of orange juice. Do not use table sugar or drink||
1061|055|S|non-diet soda to relieve these symptoms because miglitol slows||
1061|056|S|the breakdown of table sugar. Tell your doctor right away about||
1061|057|S|the reaction and the use of this product. To help prevent low||
1061|058|S|blood sugar, eat meals on a regular schedule and do not skip||
1061|059|S|meals. Check with your doctor or pharmacist to find out what you||
1061|060|S|should do if you miss a meal.||
1061|061|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1061|062|S|thirst/urination. If these symptoms occur, tell your doctor right||
1061|063|S|away. Your doctor may need to adjust your diabetes medication,||
1061|064|S|exercise program, or diet.||
1061|065|S|   This medication may rarely cause a serious intestinal||
1061|066|S|condition (pneumatosis cystoides intestinalis). Tell your doctor||
1061|067|S|right away if you develop: diarrhea that doesn't stop,||
1061|068|S|constipation, blood/mucus in stool.||
1061|069|S|   A very serious allergic reaction to this drug is rare.||
1061|070|S|However, get medical help right away if you notice any symptoms||
1061|071|S|of a serious allergic reaction, including: rash, itching/swelling||
1061|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1061|073|S|breathing.||
1061|074|S|   This is not a complete list of possible side effects. If you||
1061|075|S|notice other effects not listed above, contact your doctor or||
1061|076|S|pharmacist.||
1061|077|S|   In the US -||
1061|078|S|   Call your doctor for medical advice about side effects. You||
1061|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1061|080|S|www.fda.gov/medwatch.||
1061|081|S|   In Canada - Call your doctor for medical advice about side||
1061|082|S|effects. You may report side effects to Health Canada at||
1061|083|S|1-866-234-2345.||
1061|084|B|||
1061|085|P|PRECAUTIONS:  Before taking miglitol, tell your doctor or||
1061|086|P|pharmacist if you are allergic to it; or if you have any other||
1061|087|P|allergies. This product may contain inactive ingredients, which||
1061|088|P|can cause allergic reactions or other problems. Talk to your||
1061|089|P|pharmacist for more details.||
1061|090|P|   Before using this medication, tell your doctor or pharmacist||
1061|091|P|your medical history, especially of: intestine/bowel problems||
1061|092|P|(such as inflammatory bowel disease, blockage, ulcers), kidney||
1061|093|P|problems.||
1061|094|P|   You may experience blurred vision, dizziness, or drowsiness||
1061|095|P|due to extremely low or high blood sugar. Do not drive, use||
1061|096|P|machinery, or do anything that needs alertness or clear vision||
1061|097|P|until you can do it safely.||
1061|098|P|   Limit alcohol while taking this medication because it can||
1061|099|P|increase your risk of developing low blood sugar.||
1061|100|P|   It may be harder to control your blood sugar when your body is||
1061|101|P|stressed (such as due to fever, infection, injury, or surgery).||
1061|102|P|Consult your doctor because this may require a change in your||
1061|103|P|treatment plan, medications, or blood sugar testing.||
1061|104|P|   Before having surgery, tell your doctor or dentist about all||
1061|105|P|the products you use (including prescription drugs,||
1061|106|P|nonprescription drugs, and herbal products).||
1061|107|P|   During pregnancy, this medication should be used only when||
1061|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
1061|109|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1061|110|P|your doctor for managing your blood sugar while pregnant. Your||
1061|111|P|doctor may change your diabetes treatment during your pregnancy||
1061|112|P|(such as diet and medications including insulin).||
1061|113|P|   This drug passes into breast milk in small amounts but is||
1061|114|P|unlikely to harm a nursing infant. Consult your doctor before||
1061|115|P|breastfeeding.||
1061|116|B|||
1061|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1061|118|I|medications work or increase your risk for serious side effects.||
1061|119|I|This document does not contain all possible drug interactions.||
1061|120|I|Keep a list of all the products you use (including||
1061|121|I|prescription/nonprescription drugs and herbal products) and share||
1061|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
1061|123|I|the dosage of any medicines without your doctor's approval.||
1061|124|I|   Some products that may interact with this drug are: charcoal||
1061|125|I|products taken by mouth, digestive enzyme products (such as||
1061|126|I|amylase, pancreatin), pramlintide.||
1061|127|I|   Beta blocker medications (such as metoprolol, propranolol,||
1061|128|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1061|129|I|heartbeat you would usually feel when your blood sugar falls too||
1061|130|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1061|131|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1061|132|I|   Many drugs can affect your blood sugar, making it harder to||
1061|133|I|control. Before you start, stop, or change any medication, talk||
1061|134|I|with your doctor or pharmacist about how the medication may||
1061|135|I|affect your blood sugar. Check your blood sugar regularly as||
1061|136|I|directed and share the results with your doctor. Tell your doctor||
1061|137|I|right away if you have symptoms of high or low blood sugar. (See||
1061|138|I|also Side Effects section.) Your doctor may need to adjust your||
1061|139|I|diabetes medication, exercise program, or diet.||
1061|140|B|||
1061|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1061|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1061|143|O|poison control center right away. US residents can call||
1061|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1061|145|B|||
1061|146|N|NOTES:  Do not share this medication with others.||
1061|147|N|   Attend a diabetes education program to learn more about how to||
1061|148|N|manage your diabetes with medications, diet, exercise, and||
1061|149|N|regular medical exams.||
1061|150|N|   Learn the symptoms of high and low blood sugar and how to||
1061|151|N|treat low blood sugar. Check your blood sugar regularly as||
1061|152|N|directed.||
1061|153|N|   Lab and/or medical tests (such as kidney function, hemoglobin||
1061|154|N|A1c) should be done while you are taking this medication. Keep||
1061|155|N|all medical and lab appointments.||
1061|156|B|||
1061|157|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1061|158|D|remember. If it is near the time of the next dose, skip the||
1061|159|D|missed dose. Take your next dose at the regular time. Do not||
1061|160|D|double the dose to catch up.||
1061|161|B|||
1061|162|R|STORAGE:  Store at room temperature away from light and moisture.||
1061|163|R|Do not store in the bathroom. Keep all medications away from||
1061|164|R|children and pets.||
1061|165|R|   Do not flush medications down the toilet or pour them into a||
1061|166|R|drain unless instructed to do so. Properly discard this product||
1061|167|R|when it is expired or no longer needed. Consult your pharmacist||
1061|168|R|or local waste disposal company.||
1061|169|B|||
1061|170|M|MEDICAL ALERT:  Your condition can cause complications in a||
1061|171|M|medical emergency. For information about enrolling in MedicAlert,||
1061|172|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1061|173|B|||
1061|174|A|Information last revised May 2025.||
1061|175|A|Copyright(c) 2025 First Databank, Inc.||
1061|176|B|||
1063|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1063|002|Z|does NOT have all possible information about this product. This||
1063|003|Z|information does not assure that this product is safe, effective,||
1063|004|Z|or appropriate for you. This information is not individual||
1063|005|Z|medical advice and does not substitute for the advice of your||
1063|006|Z|health care professional. Always ask your health care||
1063|007|Z|professional for complete information about this product and your||
1063|008|Z|specific health needs.||
1063|009|B|||
1063|010|T|PRAMLINTIDE - INJECTION||
1063|011|F|(PRAM-lin-tide)||
1063|012|B|||
1063|013|C|COMMON BRAND NAME(S): Symlinpen||
1063|014|B|||
1063|015|W|WARNING:  Pramlintide may increase the risk of very low blood||
1063|016|W|sugar when used with insulin, particularly in patients with type||
1063|017|W|1 diabetes. This reaction is most likely to occur within 3 hours||
1063|018|W|after an injection. Your doctor may decrease your insulin dose||
1063|019|W|when you start pramlintide. Low blood sugar makes it hard to||
1063|020|W|think clearly, drive a car, use heavy machinery, or safely||
1063|021|W|participate in other activities that include a risk of hurting||
1063|022|W|yourself or others. (See also Side Effects and Precautions||
1063|023|W|sections.)||
1063|024|B|||
1063|025|U|USES:  Pramlintide is used with mealtime insulin and a proper||
1063|026|U|diet and exercise program to control high blood sugar in people||
1063|027|U|with type 1 and type 2 diabetes. It is used when patients who are||
1063|028|U|already using insulin need better blood sugar control.||
1063|029|U|Controlling high blood sugar helps prevent kidney damage,||
1063|030|U|blindness, nerve problems, loss of limbs, and sexual function||
1063|031|U|problems. Proper control of diabetes may also lessen your risk of||
1063|032|U|a heart attack or stroke.||
1063|033|U|   Pramlintide acts like a certain natural substance called||
1063|034|U|amylin, which lowers blood sugar. This drug works by slowing the||
1063|035|U|movement of food through your stomach. It also decreases your||
1063|036|U|appetite and the amount of sugar your liver makes. Pramlintide||
1063|037|U|does not replace insulin, but it may lower the amount of insulin||
1063|038|U|you need.||
1063|039|U|   This medication should not be used by people who are unable to||
1063|040|U|tell when they have symptoms of low blood sugar (such as||
1063|041|U|children).||
1063|042|B|||
1063|043|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1063|044|H|provided by your pharmacist before you start using pramlintide||
1063|045|H|and each time you get a refill. Ask your health care professional||
1063|046|H|how to prepare and use this medication. If you have any||
1063|047|H|questions, consult your doctor or pharmacist.||
1063|048|H|   Inject this medication under the skin just before each main||
1063|049|H|meal. Do not use pramlintide if your blood sugar is too low, if||
1063|050|H|you are planning to eat a small meal (less than 250 calories or||
1063|051|H|30 grams of carbohydrate), or if you are skipping a meal. The||
1063|052|H|injection is given in the thigh or abdomen. The dosage is based||
1063|053|H|on your medical condition and response to treatment. To reduce||
1063|054|H|the risk of nausea, your doctor may direct you to start at a low||
1063|055|H|dose of pramlintide and gradually increase the dose. Your doctor||
1063|056|H|may also direct you to lower your insulin dose and to check your||
1063|057|H|blood sugar more often. Do not change your dosage without||
1063|058|H|consulting your doctor.||
1063|059|H|   If the medication is in the refrigerator, take the medication||
1063|060|H|out of the refrigerator and allow it to reach room temperature||
1063|061|H|before you inject it. Before using, check this product for||
1063|062|H|particles or discoloration. If either is present, do not use the||
1063|063|H|liquid. Before injecting each dose, clean the skin you are going||
1063|064|H|to inject into (the injection site) with rubbing alcohol. Change||
1063|065|H|the injection site each time to lessen injury under the skin.||
1063|066|H|Never mix pramlintide and insulin in the same syringe or at the||
1063|067|H|same injection site. Inject pramlintide in an area that is at||
1063|068|H|least 2 inches (5 centimeters) away from your insulin injection||
1063|069|H|site. To lessen bruising, do not rub the injection site after a||
1063|070|H|shot. Learn how to store and discard medical supplies safely.||
1063|071|H|   Use this medication regularly in order to get the most benefit||
1063|072|H|from it.||
1063|073|H|   Do not share your pen device with another person, even if the||
1063|074|H|needle is changed. You may give other people a serious infection,||
1063|075|H|or get a serious infection from them.||
1063|076|H|   Tell your doctor if your condition does not get better or if||
1063|077|H|it gets worse (your blood sugar is too high or too low).||
1063|078|B|||
1063|079|S|SIDE EFFECTS:  Nausea, vomiting, tiredness, and upset stomach may||
1063|080|S|occur as your body adjusts to the medication. Nausea can be||
1063|081|S|reduced by starting at a low dose and increasing the dose slowly.||
1063|082|S|Redness, swelling and itching at the injection site may occur and||
1063|083|S|usually go away in a few days. If any of these effects last or||
1063|084|S|get worse, contact your doctor or pharmacist promptly.||
1063|085|S|   Remember that this medication has been prescribed because your||
1063|086|S|doctor has judged that the benefit to you is greater than the||
1063|087|S|risk of side effects. Many people using this medication do not||
1063|088|S|have serious side effects.||
1063|089|S|   Pramlintide does not usually cause low blood sugar||
1063|090|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1063|091|S|prescribed with other diabetes medications, or if you do not get||
1063|092|S|enough calories from food, or if you do unusually heavy exercise.||
1063|093|S|Talk with your doctor or pharmacist about whether the dose of||
1063|094|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1063|095|S|of low blood sugar include sudden sweating, shaking, fast||
1063|096|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1063|097|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1063|098|S|treat low blood sugar. If you don't have these reliable forms of||
1063|099|S|glucose, rapidly raise your blood sugar by eating a quick source||
1063|100|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1063|101|S|juice or non-diet soda. Tell your doctor right away about the||
1063|102|S|reaction and the use of this product. To help prevent low blood||
1063|103|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1063|104|S|Check with your doctor or pharmacist to find out what you should||
1063|105|S|do if you miss a meal.||
1063|106|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1063|107|S|thirst/urination. If these symptoms occur, tell your doctor right||
1063|108|S|away. Your doctor may need to adjust your diabetes medication,||
1063|109|S|exercise program, or diet.||
1063|110|S|   A very serious allergic reaction to this drug is rare.||
1063|111|S|However, get medical help right away if you notice any symptoms||
1063|112|S|of a serious allergic reaction, including: rash, itching/swelling||
1063|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1063|114|S|breathing.||
1063|115|S|   This is not a complete list of possible side effects. If you||
1063|116|S|notice other effects not listed above, contact your doctor or||
1063|117|S|pharmacist.||
1063|118|S|   In the US -||
1063|119|S|   Call your doctor for medical advice about side effects. You||
1063|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1063|121|S|www.fda.gov/medwatch.||
1063|122|S|   In Canada - Call your doctor for medical advice about side||
1063|123|S|effects. You may report side effects to Health Canada at||
1063|124|S|1-866-234-2345.||
1063|125|B|||
1063|126|P|PRECAUTIONS:  Before using pramlintide, tell your doctor or||
1063|127|P|pharmacist if you are allergic to it; or if you have any other||
1063|128|P|allergies. This product may contain inactive ingredients (such as||
1063|129|P|the preservative metacresol), which can cause allergic reactions||
1063|130|P|or other problems. Talk to your pharmacist for more details.||
1063|131|P|   Before using pramlintide, tell your doctor or pharmacist your||
1063|132|P|medical history, especially of: stomach/intestinal disorders (for||
1063|133|P|example, digestion problems such as gastroparesis), attacks of||
1063|134|P|low blood sugar (hypoglycemia) that required treatment.||
1063|135|P|   You may experience blurred vision, dizziness, or drowsiness||
1063|136|P|due to extremely low or high blood sugar. Do not drive, use||
1063|137|P|machinery, or do anything that needs alertness or clear vision||
1063|138|P|until you can do it safely. Limit alcoholic beverages because||
1063|139|P|alcohol can affect your blood sugar.||
1063|140|P|   It may be harder to control your blood sugar when your body is||
1063|141|P|stressed (such as due to fever, infection, injury, or surgery).||
1063|142|P|Consult your doctor because this may require a change in your||
1063|143|P|treatment plan, medications, or blood sugar testing.||
1063|144|P|   During pregnancy, this medication should be used only when||
1063|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
1063|146|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1063|147|P|your doctor for managing your blood sugar while pregnant. Your||
1063|148|P|doctor may change your diabetes treatment during your pregnancy||
1063|149|P|(such as diet and medications including insulin).||
1063|150|P|   It is unknown if pramlintide passes into breast milk. Consult||
1063|151|P|your doctor before breastfeeding.||
1063|152|B|||
1063|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1063|154|I|medications work or increase your risk for serious side effects.||
1063|155|I|This document does not contain all possible drug interactions.||
1063|156|I|Keep a list of all the products you use (including||
1063|157|I|prescription/nonprescription drugs and herbal products) and share||
1063|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
1063|159|I|the dosage of any medicines without your doctor's approval.||
1063|160|I|   Some products that may interact with this drug are: diabetes||
1063|161|I|drugs (including alpha glucosidase inhibitors such as||
1063|162|I|acarbose/miglitol), darifenacin, drugs for high blood pressure||
1063|163|I|that may make it harder to notice symptoms of low blood sugar||
1063|164|I|(such as clonidine, guanethidine), drugs that slow down or speed||
1063|165|I|up movement of food through your stomach (causing constipation or||
1063|166|I|diarrhea; drugs such as atropine, exenatide, metoclopramide),||
1063|167|I|solifenacin.||
1063|168|I|   Some other medications may not work as well if used at the||
1063|169|I|same time as pramlintide. Affected products include antibiotics,||
1063|170|I|birth control pills, pain relievers (such as acetaminophen),||
1063|171|I|among others. If you are using any of the those drugs, use them||
1063|172|I|at least 1 hour before or 2 hours after your injection. If you||
1063|173|I|have any questions about when to take your other medications, ask||
1063|174|I|your pharmacist.||
1063|175|I|   If you are using a medication that needs to be taken with||
1063|176|I|food, take it with a small meal or snack (less than 250 calories||
1063|177|I|or 30 grams of carbohydrate) at a time when you do not normally||
1063|178|I|inject pramlintide.||
1063|179|I|   Beta blocker medications (such as metoprolol, propranolol,||
1063|180|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1063|181|I|heartbeat you would usually feel when your blood sugar falls too||
1063|182|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
1063|183|I|dizziness, hunger, or sweating are unaffected by these drugs.||
1063|184|I|   Many drugs can affect your blood sugar, making it harder to||
1063|185|I|control. Before you start, stop, or change any medication, talk||
1063|186|I|with your doctor or pharmacist about how the medication may||
1063|187|I|affect your blood sugar. Check your blood sugar regularly as||
1063|188|I|directed and share the results with your doctor. Tell your doctor||
1063|189|I|right away if you have symptoms of high or low blood sugar. (See||
1063|190|I|also Side Effects section.) Your doctor may need to adjust your||
1063|191|I|diabetes medication, exercise program, or diet.||
1063|192|B|||
1063|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1063|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1063|195|O|poison control center right away. US residents can call||
1063|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1063|197|O|Symptoms of overdose may include: severe nausea, vomiting,||
1063|198|O|diarrhea, flushing, dizziness.||
1063|199|B|||
1063|200|N|NOTES:  Do not share this medication, syringes, or needles with||
1063|201|N|others.||
1063|202|N|   Attend a diabetes education program to learn more about how to||
1063|203|N|manage your diabetes with medications, diet, exercise, and||
1063|204|N|regular medical exams.||
1063|205|N|   Lab and/or medical tests (such as fasting blood glucose,||
1063|206|N|hemoglobin A1c) should be done while you are using this||
1063|207|N|medication. Keep all medical and lab appointments. Check your||
1063|208|N|blood sugar regularly as directed (usually before and after meals||
1063|209|N|and at bedtime) and share the results with your doctor.||
1063|210|B|||
1063|211|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1063|212|D|next dose at the regular time. Do not double the dose to catch||
1063|213|D|up.||
1063|214|B|||
1063|215|R|STORAGE:  Store unused injectors in the refrigerator away from||
1063|216|R|light. Do not freeze. Do not use this medication if it has been||
1063|217|R|frozen. Once used, this product may be stored in the refrigerator||
1063|218|R|or at room temperature. Discard the used injector after 30 days.||
1063|219|R|Keep all medications away from children and pets.||
1063|220|R|   Do not flush medications down the toilet or pour them into a||
1063|221|R|drain unless instructed to do so. Properly discard this product||
1063|222|R|when it is expired or no longer needed. Consult your pharmacist||
1063|223|R|or local waste disposal company.||
1063|224|B|||
1063|225|M|MEDICAL ALERT:  Your condition can cause complications in a||
1063|226|M|medical emergency. For information about enrolling in MedicAlert,||
1063|227|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1063|228|B|||
1063|229|A|Information last revised November 2025.||
1063|230|A|Copyright(c) 2025 First Databank, Inc.||
1063|231|B|||
1064|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1064|002|Z|does NOT have all possible information about this product. This||
1064|003|Z|information does not assure that this product is safe, effective,||
1064|004|Z|or appropriate for you. This information is not individual||
1064|005|Z|medical advice and does not substitute for the advice of your||
1064|006|Z|health care professional. Always ask your health care||
1064|007|Z|professional for complete information about this product and your||
1064|008|Z|specific health needs.||
1064|009|B|||
1064|010|T|BROMFENAC - OPHTHALMIC||
1064|011|F|(BROME-fen-ak)||
1064|012|B|||
1064|013|C|COMMON BRAND NAME(S): Bromday, Prolensa, Xibrom||
1064|014|B|||
1064|015|U|USES:  This medication is used to treat swelling (inflammation)||
1064|016|U|and pain in the eye after a certain type of eye surgery (cataract||
1064|017|U|surgery). Bromfenac belongs to a class of drugs known as||
1064|018|U|nonsteroidal anti-inflammatory drugs (NSAIDs). It works by||
1064|019|U|blocking the effects of certain natural substances||
1064|020|U|(prostaglandins) that cause pain and inflammation.||
1064|021|B|||
1064|022|H|HOW TO USE:  Read the Instructions for Use if available from your||
1064|023|H|pharmacist before you start using bromfenac and each time you get||
1064|024|H|a refill. If you have any questions, ask your doctor or||
1064|025|H|pharmacist.||
1064|026|H|   Use this medication in the affected eye(s) as directed by your||
1064|027|H|doctor, usually once or twice a day for 2 weeks.||
1064|028|H|   Your doctor may direct you to start using this medication the||
1064|029|H|day before or the day after your surgery. Place 1 drop into the||
1064|030|H|affected eye. Carefully follow your doctor's specific directions.||
1064|031|H|   To apply eye drops, wash your hands first. To avoid||
1064|032|H|contamination, do not touch the dropper tip or let it touch your||
1064|033|H|eye or any other surface.||
1064|034|H|   This medication should not be used while wearing contact||
1064|035|H|lenses. Consult your doctor or pharmacist for details.||
1064|036|H|   If you are wearing contact lenses, remove them before using||
1064|037|H|eye drops. Tilt your head back, look upward, and pull down the||
1064|038|H|lower eyelid to make a pouch. Hold the dropper directly over your||
1064|039|H|eye and place 1 drop into the pouch. Look downward and gently||
1064|040|H|close your eyes for 1 to 2 minutes. Place one finger at the||
1064|041|H|corner of your eye (near the nose) and apply gentle pressure.||
1064|042|H|This will prevent the medication from draining out. Try not to||
1064|043|H|blink and do not rub your eye.||
1064|044|H|   Do not rinse the dropper. Replace the dropper cap after each||
1064|045|H|use.||
1064|046|H|   If you are using another kind of eye medication (such as drops||
1064|047|H|or ointments), wait at least 5 to 10 minutes before applying||
1064|048|H|other medications. Use eye drops before eye ointments to allow||
1064|049|H|the drops to enter the eye.||
1064|050|H|   Wait several minutes for your vision to clear before driving||
1064|051|H|or operating machinery.||
1064|052|H|   Use this medication regularly in order to get the most benefit||
1064|053|H|from it. To help you remember, use it at the same time(s) each||
1064|054|H|day. Keep using it for the full time prescribed.||
1064|055|H|   Do not apply this medication more often than prescribed or||
1064|056|H|keep using it for longer than directed by your doctor. Prolonged||
1064|057|H|use of bromfenac eye drops may increase the risk of very serious||
1064|058|H|side effects of the eye.||
1064|059|B|||
1064|060|S|SIDE EFFECTS:  Temporary irritation/burning/stinging of the eye,||
1064|061|S|temporary blurred vision, watery eyes, or headache may occur. If||
1064|062|S|any of these effects last or get worse, tell your doctor or||
1064|063|S|pharmacist promptly.||
1064|064|S|   Remember that this medication has been prescribed because your||
1064|065|S|doctor has judged that the benefit to you is greater than the||
1064|066|S|risk of side effects. Many people using this medication do not||
1064|067|S|have serious side effects.||
1064|068|S|   Tell your doctor right away if you have any serious side||
1064|069|S|effects, including: severe pain/redness in the eye, sensitivity||
1064|070|S|of the eyes to light (photophobia), eye discharge,||
1064|071|S|blurry/abnormal vision, feeling as if something is in the eye,||
1064|072|S|itching/redness/pain around the eyes.||
1064|073|S|   A very serious allergic reaction to this drug is rare.||
1064|074|S|However, get medical help right away if you notice any symptoms||
1064|075|S|of a serious allergic reaction, including: rash, itching/swelling||
1064|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1064|077|S|breathing.||
1064|078|S|   If you notice other effects not listed above, contact your||
1064|079|S|doctor or pharmacist.||
1064|080|S|   In the US -||
1064|081|S|   Call your doctor for medical advice about side effects. You||
1064|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1064|083|S|www.fda.gov/medwatch.||
1064|084|S|   In Canada - Call your doctor for medical advice about side||
1064|085|S|effects. You may report side effects to Health Canada at||
1064|086|S|1-866-234-2345.||
1064|087|B|||
1064|088|P|PRECAUTIONS:  Before using bromfenac, tell your doctor or||
1064|089|P|pharmacist if you are allergic to it; or to aspirin or other||
1064|090|P|NSAIDs (such as naproxen, celecoxib); or if you have any other||
1064|091|P|allergies. This product may contain inactive ingredients (such as||
1064|092|P|sulfites), which can cause allergic reactions or other problems.||
1064|093|P|Talk to your pharmacist for more details.||
1064|094|P|   Before using this medication, tell your doctor or pharmacist||
1064|095|P|your medical history, especially of: asthma (including a history||
1064|096|P|of worsening breathing after taking aspirin or other NSAIDs),||
1064|097|P|bleeding disorders, other eye problems (such as dry eye syndrome,||
1064|098|P|corneal problems), diabetes, rheumatoid arthritis, growths in the||
1064|099|P|nose (nasal polyps).||
1064|100|P|   After you apply this drug, your vision may become temporarily||
1064|101|P|blurred. Do not drive, use machinery, or do anything that needs||
1064|102|P|clear vision until you can do it safely.||
1064|103|P|   Before having surgery, tell your doctor or dentist about all||
1064|104|P|the products you use (including prescription drugs,||
1064|105|P|nonprescription drugs, and herbal products).||
1064|106|P|   During pregnancy, this medication should be used only when||
1064|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
1064|108|P|   It is unknown if this drug passes into breast milk. Consult||
1064|109|P|your doctor before breastfeeding.||
1064|110|B|||
1064|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1064|112|I|medications work or increase your risk for serious side effects.||
1064|113|I|This document does not contain all possible drug interactions.||
1064|114|I|Keep a list of all the products you use (including||
1064|115|I|prescription/nonprescription drugs and herbal products) and share||
1064|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1064|117|I|the dosage of any medicines without your doctor's approval.||
1064|118|I|   Some products that may interact with this drug are:||
1064|119|I|anti-platelet medications (such as clopidogrel), other NSAID||
1064|120|I|medications (such as aspirin, ibuprofen), blood thinners (such as||
1064|121|I|warfarin, heparin).||
1064|122|I|   If your doctor has directed you to take low doses of aspirin||
1064|123|I|to prevent heart attack or stroke (usually 81-162 milligrams a||
1064|124|I|day), you should continue to take the aspirin. Consult your||
1064|125|I|doctor or pharmacist for more details.||
1064|126|B|||
1064|127|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1064|128|O|has overdosed and has serious symptoms such as passing out or||
1064|129|O|trouble breathing, call 911. Otherwise, call a poison control||
1064|130|O|center right away. US residents can call 1-800-222-1222. Canada||
1064|131|O|residents can call 1-844-764-7669.||
1064|132|B|||
1064|133|N|NOTES:  Do not share this medication with others.||
1064|134|B|||
1064|135|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1064|136|D|If it is near the time of the next dose, skip the missed dose.||
1064|137|D|Use your next dose at the regular time. Do not double the dose to||
1064|138|D|catch up.||
1064|139|B|||
1064|140|R|STORAGE:  Store at room temperature. Keep all medications away||
1064|141|R|from children and pets.||
1064|142|R|   Do not flush medications down the toilet or pour them into a||
1064|143|R|drain unless instructed to do so. Properly discard this product||
1064|144|R|when it is expired or no longer needed. Consult your pharmacist||
1064|145|R|or local waste disposal company.||
1064|146|B|||
1064|147|A|Information last revised May 2024.||
1064|148|A|Copyright(c) 2025 First Databank, Inc.||
1064|149|B|||
1065|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1065|002|Z|does NOT have all possible information about this product. This||
1065|003|Z|information does not assure that this product is safe, effective,||
1065|004|Z|or appropriate for you. This information is not individual||
1065|005|Z|medical advice and does not substitute for the advice of your||
1065|006|Z|health care professional. Always ask your health care||
1065|007|Z|professional for complete information about this product and your||
1065|008|Z|specific health needs.||
1065|009|B|||
1065|010|T|DICLOFENAC 1% - TOPICAL||
1065|011|F|(dye-KLOE-fen-ak)||
1065|012|B|||
1065|013|C|COMMON BRAND NAME(S): Voltaren||
1065|014|B|||
1065|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1065|016|W|diclofenac) may rarely increase the risk for a heart attack or||
1065|017|W|stroke. This effect can happen at any time while using this drug||
1065|018|W|but is more likely if you use it for a long time. The risk may be||
1065|019|W|greater in older adults or if you have heart disease or increased||
1065|020|W|risk for heart disease (for example, due to smoking, family||
1065|021|W|history of heart disease, or conditions such as high blood||
1065|022|W|pressure or diabetes). Do not use this drug right before or after||
1065|023|W|heart bypass surgery (CABG).||
1065|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
1065|025|W|bleeding from the stomach or intestines. This side effect can||
1065|026|W|occur without warning symptoms at any time while using||
1065|027|W|diclofenac. Older adults may be at higher risk for this effect.||
1065|028|W|(See also Precautions and Drug Interactions sections.)||
1065|029|W|   Stop using diclofenac and get medical help right away if you||
1065|030|W|notice any of the following rare but very serious side effects:||
1065|031|W|stomach/abdominal pain that doesn't go away, black/bloody stools,||
1065|032|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1065|033|W|shortness of breath, unusual sweating, confusion, weakness on one||
1065|034|W|side of the body, sudden vision changes, trouble speaking.||
1065|035|W|   Talk with your doctor or pharmacist about the benefits and||
1065|036|W|risks of using this medication.||
1065|037|B|||
1065|038|U|USES:  See also Warning section.||
1065|039|U|   This medication is used to relieve joint pain from arthritis.||
1065|040|U|Diclofenac belongs to a class of drugs known as nonsteroidal||
1065|041|U|anti-inflammatory drugs (NSAIDs).||
1065|042|U|   If you are treating a chronic condition such as arthritis, ask||
1065|043|U|your doctor about non-drug treatments and/or using other||
1065|044|U|medications to treat your pain.||
1065|045|B|||
1065|046|H|HOW TO USE:  Read the Medication Guide and Patient Instructions||
1065|047|H|for Use provided by your pharmacist before you start using||
1065|048|H|diclofenac and each time you get a refill. If you have any||
1065|049|H|questions, ask your doctor or pharmacist.||
1065|050|H|   This medication is for use on the skin only. To measure the||
1065|051|H|right dose, use the dosing card(s) provided with the medication.||
1065|052|H|Place a dosing card on a flat surface so that you can read the||
1065|053|H|print on the card. Squeeze an even line of the medication from||
1065|054|H|the tube onto the dosing card, using the marks on the card to||
1065|055|H|measure the prescribed dose. Gently rub the medication into the||
1065|056|H|entire affected joint as directed by your doctor, usually 4 times||
1065|057|H|daily. You may use the dosing card to apply the medication. Do||
1065|058|H|not apply the medication on skin that has cuts, infections, or||
1065|059|H|rashes.||
1065|060|H|   If the package instructions direct you to reuse the dosing||
1065|061|H|card, then after each use, hold the card with your fingertips,||
1065|062|H|rinse, and dry. When you are ready to discard the dosing card,||
1065|063|H|fold the card in half with the medication side inside and throw||
1065|064|H|away out of the reach of children and pets. Wash your hands after||
1065|065|H|using the medication unless you are using it to treat the hands.||
1065|066|H|Do not shower, bathe, or wash any treated areas for at least an||
1065|067|H|hour after applying the medication. Wait at least 10 minutes||
1065|068|H|before covering the treated area with gloves or clothing. Do not||
1065|069|H|wrap, bandage, or apply heat (such as a heating pad) to the||
1065|070|H|treated area.||
1065|071|H|   The dosage is based on your medical condition and response to||
1065|072|H|treatment. Do not apply more than 16 grams of diclofenac per day||
1065|073|H|to any single joint of the lower body (such as knee, ankle,||
1065|074|H|foot). Do not apply more than 8 grams of diclofenac per day to||
1065|075|H|any single joint of the upper body (such as hand, wrist, elbow).||
1065|076|H|No matter how many joints you are treating, do not use more than||
1065|077|H|a total of 32 grams of diclofenac per day.||
1065|078|H|   Discuss the risks and benefits of using this drug with your||
1065|079|H|doctor or pharmacist. To reduce the risk of side effects, use||
1065|080|H|this medication at the lowest effective dose for the shortest||
1065|081|H|possible time. Do not increase your dose, use it more often than||
1065|082|H|prescribed, or apply the medication to any area not prescribed by||
1065|083|H|your doctor.||
1065|084|H|   Do not get the medication in the eyes, nose, or mouth. If you||
1065|085|H|do get the medication in those areas, flush with plenty of water.||
1065|086|H|Contact your doctor right away if irritation lasts..||
1065|087|H|   For certain conditions (such as arthritis), it may take up to||
1065|088|H|2 weeks of using this drug regularly until you get the full||
1065|089|H|benefit.||
1065|090|H|   If you are using this drug "as needed" (not on a regular||
1065|091|H|schedule), remember that pain medications work best if they are||
1065|092|H|used as the first signs of pain occur. If you wait until the pain||
1065|093|H|has worsened, the medication may not work as well.||
1065|094|H|   Tell your doctor if your pain lasts or gets worse.||
1065|095|B|||
1065|096|S|SIDE EFFECTS:  See also Warning section.||
1065|097|S|   Skin irritation/redness may occur at the application site. If||
1065|098|S|this effect lasts or gets worse, tell your doctor or pharmacist||
1065|099|S|promptly.||
1065|100|S|   Remember that this medication has been prescribed because your||
1065|101|S|doctor has judged that the benefit to you is greater than the||
1065|102|S|risk of side effects. Many people using this medication do not||
1065|103|S|have serious side effects.||
1065|104|S|   This medication may raise your blood pressure. Check your||
1065|105|S|blood pressure regularly and tell your doctor if the results are||
1065|106|S|high.||
1065|107|S|   Tell your doctor right away if you have any serious side||
1065|108|S|effects, including: signs of kidney problems (such as change in||
1065|109|S|the amount of urine), symptoms of heart failure (such as swelling||
1065|110|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
1065|111|S|   This drug may rarely cause serious (possibly fatal) liver||
1065|112|S|disease. Get medical help right away if you have any symptoms of||
1065|113|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1065|114|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1065|115|S|urine.||
1065|116|S|   A very serious allergic reaction to this drug is rare.||
1065|117|S|However, get medical help right away if you notice any symptoms||
1065|118|S|of a serious allergic reaction, including: fever, swollen lymph||
1065|119|S|nodes, rash, itching/swelling (especially of the||
1065|120|S|face/tongue/throat), severe dizziness, trouble breathing.||
1065|121|S|   This is not a complete list of possible side effects. If you||
1065|122|S|notice other effects not listed above, contact your doctor or||
1065|123|S|pharmacist.||
1065|124|S|   In the US -||
1065|125|S|   Call your doctor for medical advice about side effects. You||
1065|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1065|127|S|www.fda.gov/medwatch.||
1065|128|S|   In Canada - Call your doctor for medical advice about side||
1065|129|S|effects. You may report side effects to Health Canada at||
1065|130|S|1-866-234-2345.||
1065|131|B|||
1065|132|P|PRECAUTIONS:  See also Warning section.||
1065|133|P|   Before using diclofenac, tell your doctor or pharmacist if you||
1065|134|P|are allergic to it; or to aspirin or other NSAIDs (such as||
1065|135|P|ibuprofen, naproxen, celecoxib); or if you have any other||
1065|136|P|allergies. This product may contain inactive ingredients, which||
1065|137|P|can cause allergic reactions or other problems. Talk to your||
1065|138|P|pharmacist for more details.||
1065|139|P|   Before using this medication, tell your doctor or pharmacist||
1065|140|P|your medical history, especially of: asthma (including a history||
1065|141|P|of worsening breathing after taking aspirin or other NSAIDs),||
1065|142|P|liver disease, stomach/intestine problems (such as bleeding,||
1065|143|P|ulcers), heart disease (such as previous heart attack), high||
1065|144|P|blood pressure, stroke, swelling (edema, fluid retention), blood||
1065|145|P|disorders (such as anemia), bleeding/clotting problems, growths||
1065|146|P|in the nose (nasal polyps).||
1065|147|P|   Kidney problems can sometimes occur with the use of NSAID||
1065|148|P|medications, including diclofenac. Problems are more likely to||
1065|149|P|occur if you are dehydrated, have heart failure or kidney||
1065|150|P|disease, are an older adult, or if you take certain medications||
1065|151|P|(see also Drug Interactions section). Drink plenty of fluids as||
1065|152|P|directed by your doctor to prevent dehydration and tell your||
1065|153|P|doctor right away if you have a change in the amount of urine.||
1065|154|P|   Before having surgery, tell your doctor or dentist about all||
1065|155|P|the products you use (including prescription drugs,||
1065|156|P|nonprescription drugs, and herbal products).||
1065|157|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1065|158|P|and tobacco while using this medicine may increase your risk for||
1065|159|P|stomach bleeding. Limit alcohol and stop smoking. Ask your doctor||
1065|160|P|or pharmacist about how much alcohol you may safely drink.||
1065|161|P|   This medication may make the treated area more sensitive to||
1065|162|P|the sun. Limit your time in the sun. Avoid tanning booths and||
1065|163|P|sunlamps. Wear protective clothing when outdoors. Ask your doctor||
1065|164|P|whether you should use sunscreen along with this medication. Tell||
1065|165|P|your doctor right away if you get sunburned or have skin||
1065|166|P|blisters/redness.||
1065|167|P|   Older adults may be at greater risk for stomach/intestinal||
1065|168|P|bleeding, kidney problems, heart attack, and stroke while using||
1065|169|P|this drug.||
1065|170|P|   Before using this medication, women of childbearing age should||
1065|171|P|talk with their doctor(s) about the benefits and risks. Tell your||
1065|172|P|doctor if you are pregnant or if you plan to become pregnant.||
1065|173|P|This medication may harm an unborn baby and cause problems with||
1065|174|P|normal labor/delivery. It is not recommended for use in pregnancy||
1065|175|P|from 20 weeks until delivery. If your doctor decides that you||
1065|176|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1065|177|P|you should use the lowest effective dose for the shortest||
1065|178|P|possible time. You should not use this medication after 30 weeks||
1065|179|P|of pregnancy.||
1065|180|P|   It is unknown if this form of diclofenac passes into breast||
1065|181|P|milk. Consult your doctor before breastfeeding.||
1065|182|B|||
1065|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1065|184|I|medications work or increase your risk for serious side effects.||
1065|185|I|This document does not contain all possible drug interactions.||
1065|186|I|Keep a list of all the products you use (including||
1065|187|I|prescription/nonprescription drugs and herbal products) and share||
1065|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
1065|189|I|the dosage of any medicines without your doctor's approval.||
1065|190|I|   Some products that may interact with this drug include:||
1065|191|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1065|192|I|angiotensin II receptor blockers (such as losartan, valsartan),||
1065|193|I|cidofovir, corticosteroids (such as dexamethasone, prednisone),||
1065|194|I|lithium, methotrexate, other products applied to treated skin,||
1065|195|I|"water pills" (diuretics such as furosemide).||
1065|196|I|   This medication may increase the risk of bleeding when used||
1065|197|I|with other drugs that also may cause bleeding. Examples include||
1065|198|I|antiplatelet drugs such as clopidogrel, "blood thinners" such as||
1065|199|I|dabigatran/enoxaparin/warfarin, erlotinib, among others.||
1065|200|I|   Check all prescription and nonprescription medicine labels||
1065|201|I|carefully since many medications contain pain relievers/fever||
1065|202|I|reducers (aspirin, NSAIDs such as ibuprofen, naproxen, or||
1065|203|I|ketorolac). These drugs are similar to diclofenac and may||
1065|204|I|increase your risk of side effects if taken together. However, if||
1065|205|I|your doctor has told you to take low-dose aspirin to prevent||
1065|206|I|heart attack or stroke (usually 81-162 milligrams a day), you||
1065|207|I|should keep taking the aspirin unless your doctor tells you not||
1065|208|I|to. Ask your doctor or pharmacist for more details.||
1065|209|B|||
1065|210|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1065|211|O|has overdosed and has serious symptoms such as passing out or||
1065|212|O|trouble breathing, call 911. Otherwise, call a poison control||
1065|213|O|center right away. US residents can call 1-800-222-1222. Canada||
1065|214|O|residents can call 1-844-764-7669. Symptoms of||
1065|215|O|overdose/swallowing may include: severe stomach pain, change in||
1065|216|O|the amount of urine, slow/shallow breathing.||
1065|217|B|||
1065|218|N|NOTES:  Do not share this medication with others.||
1065|219|N|   Lab and/or medical tests (such as blood pressure, complete||
1065|220|N|blood count, liver/kidney function) should be done while you are||
1065|221|N|using this medication. Keep all medical and lab appointments.||
1065|222|N|Consult your doctor for more details.||
1065|223|N|   Lifestyle changes (such as weight loss if needed,||
1065|224|N|strengthening/conditioning exercises) may help improve your||
1065|225|N|flexibility and joint function. Consult your doctor for specific||
1065|226|N|instructions.||
1065|227|B|||
1065|228|D|MISSED DOSE:  If you are prescribed this drug on a regular||
1065|229|D|schedule (not just "as needed") and you miss a dose, use it as||
1065|230|D|soon as you remember. If it is near the time of the next dose,||
1065|231|D|skip the missed dose. Use your next dose at the regular time. Do||
1065|232|D|not double the dose to catch up.||
1065|233|B|||
1065|234|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
1065|235|R|medications away from children and pets.||
1065|236|R|   Do not flush medications down the toilet or pour them into a||
1065|237|R|drain unless instructed to do so. Properly discard this product||
1065|238|R|when it is expired or no longer needed. Consult your pharmacist||
1065|239|R|or local waste disposal company.||
1065|240|B|||
1065|241|A|Information last revised November 2025.||
1065|242|A|Copyright(c) 2025 First Databank, Inc.||
1065|243|B|||
1066|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1066|002|Z|does NOT have all possible information about this product. This||
1066|003|Z|information does not assure that this product is safe, effective,||
1066|004|Z|or appropriate for you. This information is not individual||
1066|005|Z|medical advice and does not substitute for the advice of your||
1066|006|Z|health care professional. Always ask your health care||
1066|007|Z|professional for complete information about this product and your||
1066|008|Z|specific health needs.||
1066|009|B|||
1066|010|T|FUSIDIC ACID - OPHTHALMIC||
1066|011|F|(fue-SID-ik)||
1066|012|B|||
1066|013|U|USES:  This medication is used to treat infections of the eye.||
1066|014|U|Fusidic acid is an antibiotic that works by stopping the growth||
1066|015|U|of bacteria.||
1066|016|U|   This medication treats only bacterial eye infections. It will||
1066|017|U|not work for other types of eye infections. Unnecessary use or||
1066|018|U|misuse of any antibiotic can lead to its decreased effectiveness.||
1066|019|B|||
1066|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1066|021|H|from your pharmacist before you start using fusidic acid and each||
1066|022|H|time you get a refill. If you have any questions, ask your doctor||
1066|023|H|or pharmacist.||
1066|024|H|   Use this medication in the affected eye(s) as directed by your||
1066|025|H|doctor, usually every 12 hours.||
1066|026|H|   Do not wear contact lenses while you are using this medicine.||
1066|027|H|Sterilize contact lenses according to manufacturer's directions,||
1066|028|H|and check with your doctor before you begin using them again.||
1066|029|H|   To apply eye drops, wash your hands first. To avoid||
1066|030|H|contamination, do not touch the dropper tip or let it touch your||
1066|031|H|eye or any other surface. Tilt your head back, look upward, and||
1066|032|H|pull down the lower eyelid to make a pouch. Hold the dropper||
1066|033|H|directly over your eye and place 1 drop into the pouch. Look||
1066|034|H|downward and gently close your eyes for 1 to 2 minutes. Place one||
1066|035|H|finger at the corner of your eye (near the nose) and apply gentle||
1066|036|H|pressure. This will prevent the medication from draining out. Try||
1066|037|H|not to blink and do not rub your eye.||
1066|038|H|   Repeat these steps if applying this medication to your other||
1066|039|H|eye. Even though you may have an infection in only one eye, your||
1066|040|H|doctor may direct you to treat both eyes so that the healthy eye||
1066|041|H|does not become infected as well. Do not rinse the dropper. If||
1066|042|H|you are using the multi-dose tube, replace the cap after each||
1066|043|H|use. If you are using the single-dose dropper, discard the||
1066|044|H|dropper after using.||
1066|045|H|   You may notice a white powder around your eye that forms as||
1066|046|H|the drop dries. This is normal and not harmful. You may wipe the||
1066|047|H|powder away with a soft tissue or cotton pad.||
1066|048|H|   If the doctor has directed you to give the drops to a child,||
1066|049|H|you may put the drops in their eyes when they are lying down or||
1066|050|H|asleep.||
1066|051|H|   If you are using another kind of eye medication (such as drops||
1066|052|H|or ointments), wait at least 5 to 10 minutes before applying||
1066|053|H|other medications. Use eye drops before eye ointments to allow||
1066|054|H|the drops to enter the eye.||
1066|055|H|   Wait several minutes for your vision to clear before driving||
1066|056|H|or operating machinery.||
1066|057|H|   Use this medication regularly to get the most benefit from it.||
1066|058|H|To help you remember, use it at the same times each day. Continue||
1066|059|H|to use this medication for the full time prescribed, even if||
1066|060|H|symptoms disappear after a few days. Stopping the medication too||
1066|061|H|early may result in a return of the infection.||
1066|062|H|   Tell your doctor if your condition lasts or gets worse after 7||
1066|063|H|days.||
1066|064|B|||
1066|065|S|SIDE EFFECTS:  Temporary eye irritation/stinging/watering or||
1066|066|S|blurred vision may occur. If any of these effects last or get||
1066|067|S|worse, tell your doctor or pharmacist promptly.||
1066|068|S|   Remember that this medication has been prescribed because your||
1066|069|S|doctor has judged that the benefit to you is greater than the||
1066|070|S|risk of side effects. Many people using this medication do not||
1066|071|S|have serious side effects.||
1066|072|S|   Use of this medication for prolonged or repeated periods may||
1066|073|S|result in other types of eye infections. Do not use it for longer||
1066|074|S|than prescribed. Contact your doctor if you notice new or||
1066|075|S|worsening eye symptoms.||
1066|076|S|   A very serious allergic reaction to this drug is rare.||
1066|077|S|However, get medical help right away if you notice any symptoms||
1066|078|S|of a serious allergic reaction, including: rash, itching/swelling||
1066|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1066|080|S|breathing.||
1066|081|S|   This is not a complete list of possible side effects. If you||
1066|082|S|notice other effects not listed above, contact your doctor or||
1066|083|S|pharmacist.||
1066|084|S|   In the US -||
1066|085|S|   Call your doctor for medical advice about side effects. You||
1066|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1066|087|S|www.fda.gov/medwatch.||
1066|088|S|   In Canada - Call your doctor for medical advice about side||
1066|089|S|effects. You may report side effects to Health Canada at||
1066|090|S|1-866-234-2345.||
1066|091|B|||
1066|092|P|PRECAUTIONS:  Before using fusidic acid, tell your doctor or||
1066|093|P|pharmacist if you are allergic to it; or if you have any other||
1066|094|P|allergies. This product may contain inactive ingredients (such as||
1066|095|P|preservatives like benzalkonium chloride), which can cause||
1066|096|P|allergic reactions or other problems. Talk to your pharmacist for||
1066|097|P|more details.||
1066|098|P|   Before using this medication, tell your doctor or pharmacist||
1066|099|P|your medical history, especially of: other eye problems, contact||
1066|100|P|lens use.||
1066|101|P|   After you apply this drug, your vision may become temporarily||
1066|102|P|blurred. Do not drive, use machinery, or do anything that needs||
1066|103|P|clear vision until you can do it safely.||
1066|104|P|   During pregnancy, this medication should be used only when||
1066|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
1066|106|P|   It is unknown if this drug passes into breast milk. Consult||
1066|107|P|your doctor before breastfeeding.||
1066|108|B|||
1066|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1066|110|I|medications work or increase your risk for serious side effects.||
1066|111|I|This document does not contain all possible drug interactions.||
1066|112|I|Keep a list of all the products you use (including||
1066|113|I|prescription/nonprescription drugs and herbal products) and share||
1066|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
1066|115|I|the dosage of any medicines without your doctor's approval.||
1066|116|B|||
1066|117|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1066|118|O|has overdosed and has serious symptoms such as passing out or||
1066|119|O|trouble breathing, call 911. Otherwise, call a poison control||
1066|120|O|center right away. US residents can call 1-800-222-1222. Canada||
1066|121|O|residents can call 1-844-764-7669.||
1066|122|B|||
1066|123|N|NOTES:  Do not share this medication with others.||
1066|124|N|   This medication has been prescribed for your current condition||
1066|125|N|only. Throw away the unused medication after treatment is||
1066|126|N|completed. Do not use it later for another infection unless your||
1066|127|N|doctor tells you to.||
1066|128|B|||
1066|129|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1066|130|D|If it is near the time of the next dose, skip the missed dose.||
1066|131|D|Use your next dose at the regular time. Do not double the dose to||
1066|132|D|catch up.||
1066|133|B|||
1066|134|R|STORAGE:  Store at room temperature or in the refrigerator. Once||
1066|135|R|the multi-dose tube is opened, this medication expires after 1||
1066|136|R|month. Keep all medications away from children and pets.||
1066|137|R|   Do not flush medications down the toilet or pour them into a||
1066|138|R|drain unless instructed to do so. Properly discard this product||
1066|139|R|when it is expired or no longer needed. Consult your pharmacist||
1066|140|R|or local waste disposal company.||
1066|141|B|||
1066|142|A|Information last revised September 2024.||
1066|143|A|Copyright(c) 2025 First Databank, Inc.||
1066|144|B|||
1067|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1067|002|Z|does NOT have all possible information about this product. This||
1067|003|Z|information does not assure that this product is safe, effective,||
1067|004|Z|or appropriate for you. This information is not individual||
1067|005|Z|medical advice and does not substitute for the advice of your||
1067|006|Z|health care professional. Always ask your health care||
1067|007|Z|professional for complete information about this product and your||
1067|008|Z|specific health needs.||
1067|009|B|||
1067|010|T|SINECATECHINS (CAMELLIA SINENSIS) OINTMENT - TOPICAL||
1067|011|F|(sin-e-KAT-e-kins/kuh-MEE-lee-uh SI-nuhn-sis)||
1067|012|B|||
1067|013|C|COMMON BRAND NAME(S): Veregen||
1067|014|B|||
1067|015|U|USES:  Sinecatechins are used to treat warts on and around the||
1067|016|U|genitals and anus. These warts are caused by the human||
1067|017|U|papillomavirus (HPV). Sinecatechins are natural substances found||
1067|018|U|in certain green tea leaves. It is not known how this medication||
1067|019|U|works.||
1067|020|U|   This medication does not cure warts, but it may help the||
1067|021|U|infection clear faster. New warts may occur during or after||
1067|022|U|treatment. This medication does not prevent the spread of warts||
1067|023|U|through sexual contact, and it may weaken condoms and diaphragms.||
1067|024|U|Talk to your doctor about safer sex practices.||
1067|025|B|||
1067|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1067|027|H|from your pharmacist before you start using this product and each||
1067|028|H|time you get a refill. If you have any questions, ask your doctor||
1067|029|H|or pharmacist.||
1067|030|H|   Use this medication on the skin only. Wash your hands before||
1067|031|H|and after applying. Apply the ointment to all warts as directed||
1067|032|H|by your doctor, usually 3 times a day. Use your finger to apply a||
1067|033|H|small amount, about 0.2 inches (0.5 centimeters), to completely||
1067|034|H|cover each wart with a thin layer. Do not wash off the ointment||
1067|035|H|from the previous treatment before re-applying. Always re-apply||
1067|036|H|the ointment after taking your usual baths/showers. Do not cover||
1067|037|H|the treated area with bandages or other waterproof dressings. You||
1067|038|H|may cover the area with cotton gauze or cotton underwear. Do not||
1067|039|H|use more often or for longer than prescribed.||
1067|040|H|   Male patients who are not circumcised and who are treating||
1067|041|H|warts under the foreskin should pull the foreskin back and clean||
1067|042|H|the area daily, then apply this medication.||
1067|043|H|   Women using tampons should insert the tampon before applying||
1067|044|H|the ointment. If you need to change the tampon while the ointment||
1067|045|H|is on the skin, avoid getting the ointment inside the vagina.||
1067|046|H|   Do not use this medication inside the vagina or anus or on an||
1067|047|H|open sore. Avoid touching your eyes, nose, or mouth while the||
1067|048|H|ointment is on your finger. If you get this medication in those||
1067|049|H|areas, flush with plenty of water. If irritation occurs, contact||
1067|050|H|your doctor right away.||
1067|051|H|   Avoid sexual contact while using this product. This product||
1067|052|H|may weaken condoms and vaginal diaphragms. This effect increases||
1067|053|H|the risk of pregnancy and passing sexually transmitted disease||
1067|054|H|(including genital warts) to others. Wash the product off before||
1067|055|H|sexual activity. Ask your doctor about safer sex practices.||
1067|056|H|   Use this medication regularly to get the most benefit from it.||
1067|057|H|Continue treatment until the warts are gone. Do not use for||
1067|058|H|longer than 16 weeks unless directed by your doctor. Tell your||
1067|059|H|doctor if your condition does not get better or if new warts||
1067|060|H|appear.||
1067|061|B|||
1067|062|S|SIDE EFFECTS:  Mild skin reactions such as||
1067|063|S|itching/burning/pain/swelling/reddening of the treated area may||
1067|064|S|occur. If any of these effects last or get worse, tell your||
1067|065|S|doctor or pharmacist promptly.||
1067|066|S|   Remember that this medication has been prescribed because your||
1067|067|S|doctor has judged that the benefit to you is greater than the||
1067|068|S|risk of side effects. Many people using this medication do not||
1067|069|S|have serious side effects.||
1067|070|S|   Tell your doctor right away if you have any serious side||
1067|071|S|effects, including: blistering/oozing/peeling skin in treated||
1067|072|S|area, open sore in treated area (skin ulcer).||
1067|073|S|   If you are an uncircumcised male who is using this drug to||
1067|074|S|treat warts on the penis, narrowing of the foreskin (phimosis)||
1067|075|S|may rarely occur. If you notice tightening/pain in your foreskin,||
1067|076|S|tell your doctor right away.||
1067|077|S|   A very serious allergic reaction to this drug is rare.||
1067|078|S|However, get medical help right away if you notice any symptoms||
1067|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1067|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1067|081|S|breathing.||
1067|082|S|   This is not a complete list of possible side effects. If you||
1067|083|S|notice other effects not listed above, contact your doctor or||
1067|084|S|pharmacist.||
1067|085|S|   In the US -||
1067|086|S|   Call your doctor for medical advice about side effects. You||
1067|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1067|088|S|www.fda.gov/medwatch.||
1067|089|S|   In Canada - Call your doctor for medical advice about side||
1067|090|S|effects. You may report side effects to Health Canada at||
1067|091|S|1-866-234-2345.||
1067|092|B|||
1067|093|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1067|094|P|pharmacist if you are allergic to it; or if you are allergic to||
1067|095|P|green tea; or if you have any other allergies. This product may||
1067|096|P|contain inactive ingredients, which can cause allergic reactions||
1067|097|P|or other problems. Talk to your pharmacist for more details.||
1067|098|P|   Before using this medication, tell your doctor or pharmacist||
1067|099|P|your medical history, especially of: open sores in the area being||
1067|100|P|treated, recent/unhealed treatment or wound on the wart area||
1067|101|P|(such as podophyllin, liquid nitrogen, surgery), immune system||
1067|102|P|problem.||
1067|103|P|   This product may stain clothing and bedding.||
1067|104|P|   Do not expose the treated area to sunlight, tanning booths, or||
1067|105|P|sunlamps.||
1067|106|P|   Genital/anal warts are caused by a virus called human||
1067|107|P|papillomavirus (HPV). This product does not destroy the virus but||
1067|108|P|only helps to get rid of the wart. New warts may form even while||
1067|109|P|you are being treated.||
1067|110|P|   You may also be able to infect any sexual partner who comes||
1067|111|P|into contact with the areas of skin infected with HPV. To reduce||
1067|112|P|the risk of spreading HPV to others, always use effective barrier||
1067|113|P|protections (such as latex or polyurethane condoms, dental dams)||
1067|114|P|during all sexual activity. Consult your doctor or pharmacist for||
1067|115|P|more details.||
1067|116|P|   During treatment of genital/anal warts, avoid all sexual||
1067|117|P|contact while the ointment is on the skin. Condoms, dental dams,||
1067|118|P|and diaphragms may be weakened by the ointment. They may not work||
1067|119|P|as well to prevent pregnancy or the spread of HPV or other||
1067|120|P|sexually transmitted diseases (such as HIV).||
1067|121|P|   During pregnancy, this medication should be used only when||
1067|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
1067|123|P|   It is unknown if this drug passes into breast milk. Consult||
1067|124|P|your doctor before breastfeeding.||
1067|125|B|||
1067|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1067|127|I|medications work or increase your risk for serious side effects.||
1067|128|I|This document does not contain all possible drug interactions.||
1067|129|I|Keep a list of all the products you use (including||
1067|130|I|prescription/nonprescription drugs and herbal products) and share||
1067|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
1067|132|I|the dosage of any medicines without your doctor's approval.||
1067|133|B|||
1067|134|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1067|135|O|has overdosed and has serious symptoms such as passing out or||
1067|136|O|trouble breathing, call 911. Otherwise, call a poison control||
1067|137|O|center right away. US residents can call 1-800-222-1222. Canada||
1067|138|O|residents can call 1-844-764-7669.||
1067|139|B|||
1067|140|N|NOTES:  Do not share this medication with others.||
1067|141|N|   This medication has been prescribed for your current condition||
1067|142|N|only. Do not use it later for another infection unless your||
1067|143|N|doctor tells you to.||
1067|144|N|   Be sure to keep all medical appointments. HPV can increase the||
1067|145|N|risk of cancer of the cervix. It is very important that women||
1067|146|N|exposed to HPV have regular PAP tests to check for cancer.||
1067|147|B|||
1067|148|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1067|149|D|If it is near the time of the next dose, skip the missed dose.||
1067|150|D|Use your next dose at the regular time. Do not double the dose to||
1067|151|D|catch up.||
1067|152|B|||
1067|153|R|STORAGE:  Store in the refrigerator or at room temperature. Do||
1067|154|R|not freeze. Keep all medications away from children and pets.||
1067|155|R|   Do not flush medications down the toilet or pour them into a||
1067|156|R|drain unless instructed to do so. Properly discard this product||
1067|157|R|when it is expired or no longer needed. Consult your pharmacist||
1067|158|R|or local waste disposal company.||
1067|159|B|||
1067|160|A|Information last revised November 2024.||
1067|161|A|Copyright(c) 2025 First Databank, Inc.||
1067|162|B|||
1068|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1068|002|Z|does NOT have all possible information about this product. This||
1068|003|Z|information does not assure that this product is safe, effective,||
1068|004|Z|or appropriate for you. This information is not individual||
1068|005|Z|medical advice and does not substitute for the advice of your||
1068|006|Z|health care professional. Always ask your health care||
1068|007|Z|professional for complete information about this product and your||
1068|008|Z|specific health needs.||
1068|009|B|||
1068|010|T|METYROSINE - ORAL||
1068|011|F|(me-TYE-roe-seen)||
1068|012|B|||
1068|013|C|COMMON BRAND NAME(S): Demser||
1068|014|B|||
1068|015|U|USES:  This medication is used to treat high blood pressure in||
1068|016|U|people with a certain adrenal gland tumor (pheochromocytoma).||
1068|017|U|Metyrosine is used to prevent high blood pressure before and||
1068|018|U|immediately after surgery to remove the tumor. It is also used||
1068|019|U|long-term in people who cannot have the surgery. It is not used||
1068|020|U|for other kinds of high blood pressure.||
1068|021|U|   Metyrosine prevents the tumor from making certain natural||
1068|022|U|substances (catecholamines) that raise the blood pressure and||
1068|023|U|make the heart beat faster. Lowering the amount of catecholamines||
1068|024|U|lessens the risk of a very serious attack of high blood pressure||
1068|025|U|(hypertensive crisis).||
1068|026|B|||
1068|027|H|HOW TO USE:  Take this medication by mouth with or without food||
1068|028|H|as directed by your doctor, usually 4 times a day. The dosage is||
1068|029|H|based on your medical condition and response to treatment.||
1068|030|H|   Your doctor may direct you to start taking this drug at a low||
1068|031|H|dose and slowly increase your dose until you are taking the best||
1068|032|H|dose for you. Your doctor will check your blood pressure and||
1068|033|H|order lab tests (such as urine tests for catecholamines) to find||
1068|034|H|the best dose.||
1068|035|H|   During treatment with this medication, it is important that||
1068|036|H|you get plenty of fluids and pass urine often to help avoid||
1068|037|H|kidney and bladder side effects. Ask your doctor how much fluid||
1068|038|H|you should drink and how often you should urinate each day, and||
1068|039|H|follow these instructions carefully.||
1068|040|H|   Use this medication regularly to get the most benefit from it.||
1068|041|H|To help you remember, take it at the same times each day. Do not||
1068|042|H|stop taking this medication without consulting your doctor. Keep||
1068|043|H|taking this medication even if you feel well. Most people with||
1068|044|H|high blood pressure do not feel sick. You may have trouble||
1068|045|H|sleeping (insomnia) for 2 to 3 days after you stop taking this||
1068|046|H|medication. Tell your doctor if these symptoms last or get worse||
1068|047|H|or if you have other symptoms of very high blood pressure (such||
1068|048|H|as headache, nausea, sweating, fast heartbeat).||
1068|049|H|   This medication is usually taken for at least 5 to 7 days||
1068|050|H|before surgery.||
1068|051|H|   Tell your doctor if your condition does not get better or if||
1068|052|H|it gets worse (for example, your blood pressure readings remain||
1068|053|H|high or increase, you have headache, nausea, sweating, fast||
1068|054|H|heartbeat).||
1068|055|B|||
1068|056|S|SIDE EFFECTS:  Drowsiness, tiredness, dizziness, lightheadedness,||
1068|057|S|dry mouth, and diarrhea may occur as your body adjusts to the||
1068|058|S|medication. If any of these effects last or get worse, tell your||
1068|059|S|doctor or pharmacist promptly.||
1068|060|S|   To reduce the risk of dizziness and lightheadedness, get up||
1068|061|S|slowly when rising from a sitting or lying position.||
1068|062|S|   Remember that this medication has been prescribed because your||
1068|063|S|doctor has judged that the benefit to you is greater than the||
1068|064|S|risk of side effects. Many people using this medication do not||
1068|065|S|have serious side effects.||
1068|066|S|   Tell your doctor right away if you have any serious side||
1068|067|S|effects, including: difficulty speaking, drooling,||
1068|068|S|unwanted/uncontrolled movements, muscle stiffness, shaking||
1068|069|S|(tremor), decrease in sexual ability, tenderness/swelling of the||
1068|070|S|breast, mental/mood changes (such as confusion, depression,||
1068|071|S|severe anxiety), signs of kidney problems (such as change in the||
1068|072|S|amount of urine, painful urination, pink/bloody urine).||
1068|073|S|   A very serious allergic reaction to this drug is rare.||
1068|074|S|However, get medical help right away if you notice any symptoms||
1068|075|S|of a serious allergic reaction, including: rash, itching/swelling||
1068|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1068|077|S|breathing.||
1068|078|S|   This is not a complete list of possible side effects. If you||
1068|079|S|notice other effects not listed above, contact your doctor or||
1068|080|S|pharmacist.||
1068|081|S|   In the US -||
1068|082|S|   Call your doctor for medical advice about side effects. You||
1068|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1068|084|S|www.fda.gov/medwatch.||
1068|085|S|   In Canada - Call your doctor for medical advice about side||
1068|086|S|effects. You may report side effects to Health Canada at||
1068|087|S|1-866-234-2345.||
1068|088|B|||
1068|089|P|PRECAUTIONS:  Before taking metyrosine, tell your doctor or||
1068|090|P|pharmacist if you are allergic to it; or if you have any other||
1068|091|P|allergies. This product may contain inactive ingredients, which||
1068|092|P|can cause allergic reactions or other problems. Talk to your||
1068|093|P|pharmacist for more details.||
1068|094|P|   Before using this medication, tell your doctor or pharmacist||
1068|095|P|your medical history, especially of: kidney disease, liver||
1068|096|P|disease, dehydration.||
1068|097|P|   Before having surgery, tell your doctor or dentist about all||
1068|098|P|the products you use (including prescription drugs,||
1068|099|P|nonprescription drugs, and herbal products).||
1068|100|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1068|101|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1068|102|P|machinery, or do anything that needs alertness until you can do||
1068|103|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1068|104|P|are using marijuana (cannabis). Alcohol may also cause you to||
1068|105|P|become dehydrated.||
1068|106|P|   During pregnancy, this medication should be used only when||
1068|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
1068|108|P|   It is unknown if this drug passes into breast milk. Consult||
1068|109|P|your doctor before breastfeeding.||
1068|110|B|||
1068|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1068|112|I|medications work or increase your risk for serious side effects.||
1068|113|I|This document does not contain all possible drug interactions.||
1068|114|I|Keep a list of all the products you use (including||
1068|115|I|prescription/nonprescription drugs and herbal products) and share||
1068|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1068|117|I|the dosage of any medicines without your doctor's approval.||
1068|118|I|   Some products that may interact with this drug are:||
1068|119|I|anti-psychotic medication (such as haloperidol, thiothixene),||
1068|120|I|certain drugs (phenothiazines) used to treat mental/mood||
1068|121|I|conditions or nausea (such as chlorpromazine, prochlorperazine).||
1068|122|I|   Tell your doctor or pharmacist if you are taking other||
1068|123|I|products that cause drowsiness such as opioid pain or cough||
1068|124|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1068|125|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1068|126|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1068|127|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1068|128|I|diphenhydramine).||
1068|129|I|   Check the labels on all your medicines (such as allergy or||
1068|130|I|cough-and-cold products) because they may contain ingredients||
1068|131|I|that cause drowsiness. Ask your pharmacist about using those||
1068|132|I|products safely.||
1068|133|I|   Some products have ingredients that could raise your blood||
1068|134|I|pressure. Tell your pharmacist what products you are using, and||
1068|135|I|ask how to use them safely (especially cough-and-cold products,||
1068|136|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1068|137|B|||
1068|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1068|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1068|140|O|poison control center right away. US residents can call||
1068|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1068|142|B|||
1068|143|N|NOTES:  Do not share this medication with others.||
1068|144|N|   Lab and/or medical tests (such as blood pressure, EKG, urine||
1068|145|N|catecholamine tests) should be done while you are taking this||
1068|146|N|medication. Keep all medical and lab appointments. Consult your||
1068|147|N|doctor for more details.||
1068|148|N|   Have your blood pressure checked regularly while taking this||
1068|149|N|medication. Learn how to monitor your own blood pressure at home,||
1068|150|N|and share the results with your doctor.||
1068|151|B|||
1068|152|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1068|153|D|remember. If it is near the time of the next dose, skip the||
1068|154|D|missed dose. Take your next dose at the regular time. Do not||
1068|155|D|double the dose to catch up.||
1068|156|B|||
1068|157|R|STORAGE:  Store at room temperature away from light and moisture.||
1068|158|R|Do not store in the bathroom. Keep all medications away from||
1068|159|R|children and pets.||
1068|160|R|   Do not flush medications down the toilet or pour them into a||
1068|161|R|drain unless instructed to do so. Properly discard this product||
1068|162|R|when it is expired or no longer needed. Consult your pharmacist||
1068|163|R|or local waste disposal company.||
1068|164|B|||
1068|165|A|Information last revised May 2024.||
1068|166|A|Copyright(c) 2025 First Databank, Inc.||
1068|167|B|||
1069|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1069|002|Z|does NOT have all possible information about this product. This||
1069|003|Z|information does not assure that this product is safe, effective,||
1069|004|Z|or appropriate for you. This information is not individual||
1069|005|Z|medical advice and does not substitute for the advice of your||
1069|006|Z|health care professional. Always ask your health care||
1069|007|Z|professional for complete information about this product and your||
1069|008|Z|specific health needs.||
1069|009|B|||
1069|010|T|CIDOFOVIR - INJECTION||
1069|011|F|(sye-DOH-foh-veer)||
1069|012|B|||
1069|013|C|COMMON BRAND NAME(S): Vistide||
1069|014|B|||
1069|015|W|WARNING:  This medication may cause serious (possibly fatal)||
1069|016|W|kidney problems. To prevent kidney problems, your doctor will||
1069|017|W|usually prescribe another medication (probenecid) and direct you||
1069|018|W|to receive fluids into a vein. Avoid other medications that may||
1069|019|W|also damage your kidneys (see also Drug Interactions section).||
1069|020|W|Tell your doctor right away if you have any signs of kidney||
1069|021|W|problems, such as change in the amount of urine, frothy urine, or||
1069|022|W|bloody/pink urine.||
1069|023|W|   This medication can lower the body's ability to fight an||
1069|024|W|infection. Tell your doctor right away if you develop any signs||
1069|025|W|of an infection (such as sore throat that doesn't go away, fever,||
1069|026|W|chills).||
1069|027|W|   Lab and/or medical tests (such as kidney function, complete||
1069|028|W|blood counts) should be performed before each dose to check for||
1069|029|W|these side effects. Consult your doctor for more details. Keep||
1069|030|W|all medical and lab appointments.||
1069|031|W|   Cidofovir has caused tumors in lab animals. Although there is||
1069|032|W|no information in humans, cidofovir should be considered||
1069|033|W|cancer-causing (carcinogenic). See also How to Use section.||
1069|034|B|||
1069|035|U|USES:  This drug is used with probenecid to treat a certain viral||
1069|036|U|eye infection (retinitis due to cytomegalovirus-CMV) in people||
1069|037|U|with AIDS. It lowers your risk of blindness and other vision||
1069|038|U|problems. Cidofovir belongs to a class of drugs known as||
1069|039|U|antivirals. It works by stopping the growth of the virus.||
1069|040|U|   Cidofovir is not a cure for CMV retinitis, and your disease||
1069|041|U|may still worsen during and after treatment.||
1069|042|B|||
1069|043|V|OTHER USES:  This section contains uses of this drug that are not||
1069|044|V|listed in the approved professional labeling for the drug but||
1069|045|V|that may be prescribed by your health care professional. Use this||
1069|046|V|drug for a condition that is listed in this section only if it||
1069|047|V|has been so prescribed by your health care professional.||
1069|048|V|   This drug may also be used for herpes simplex virus infections||
1069|049|V|that have not responded to other treatment.||
1069|050|B|||
1069|051|H|HOW TO USE:  This medication is given by injection into a vein as||
1069|052|H|directed by your doctor, usually every 1 to 2 weeks. It is||
1069|053|H|injected slowly into a vein over 1 hour. This medication should||
1069|054|H|not be injected into the eyes. Permanent loss of vision may||
1069|055|H|occur.||
1069|056|H|   Dosage is based on your medical condition, body weight, and||
1069|057|H|response to treatment. You will usually receive IV fluids before||
1069|058|H|your dose of cidofovir. Your doctor will also direct you to take||
1069|059|H|probenecid by mouth before and after you receive cidofovir. To||
1069|060|H|prevent kidney problems, drink plenty of fluids unless otherwise||
1069|061|H|directed by your doctor. This is especially important if you are||
1069|062|H|vomiting or having diarrhea.||
1069|063|H|   If you are giving this medication to yourself at home, learn||
1069|064|H|all preparation and usage instructions from your health care||
1069|065|H|professional. Before using, check this product for particles or||
1069|066|H|discoloration. If either is present, do not use the liquid. Learn||
1069|067|H|how to store and discard medical supplies safely.||
1069|068|H|   It is very important to use the probenecid with this||
1069|069|H|medication exactly as prescribed by your doctor. Nausea and||
1069|070|H|vomiting due to probenecid may be prevented by taking it after||
1069|071|H|meals. Your doctor may also prescribe another medication to||
1069|072|H|prevent nausea, and may direct you to take antihistamines (such||
1069|073|H|as diphenhydramine) and/or acetaminophen to prevent allergic||
1069|074|H|reactions to probenecid.||
1069|075|H|   Use this medication regularly to get the most benefit from it.||
1069|076|H|To help you remember, mark your calendar with a reminder.||
1069|077|H|   Do not use more or less of this drug than prescribed or stop||
1069|078|H|using it (or your HIV medicines) even for a short time unless||
1069|079|H|directed to do so by your doctor. Doing so may cause the amount||
1069|080|H|of virus to increase, make the infection more difficult to treat||
1069|081|H|(resistant), or worsen side effects.||
1069|082|H|   Avoid direct contact of this medicine with the||
1069|083|H|skin/eyes/mouth. If contact occurs, wash thoroughly with soap and||
1069|084|H|water. For eyes, rinse with a steady stream of tap water for at||
1069|085|H|least 5 minutes.||
1069|086|B|||
1069|087|S|SIDE EFFECTS:  See also Warning section.||
1069|088|S|   Nausea may occur. Headache, nausea, and vomiting may occur||
1069|089|S|with probenecid use. If any of these effects last or get worse,||
1069|090|S|tell your doctor or pharmacist promptly.||
1069|091|S|   Remember that this medication has been prescribed because your||
1069|092|S|doctor has judged that the benefit to you is greater than the||
1069|093|S|risk of side effects. Many people using this medication do not||
1069|094|S|have serious side effects.||
1069|095|S|   Tell your doctor right away if you have any serious side||
1069|096|S|effects, including: nausea/vomiting that doesn't stop, dark||
1069|097|S|urine, swelling, loss of appetite, unusual||
1069|098|S|tiredness/sluggishness, stomach/abdominal pain, muscle loss,||
1069|099|S|signs of infection (such as sore throat that doesn't go away,||
1069|100|S|fever, chills), vision changes, new/increased eye redness or||
1069|101|S|irritation, new/increased eye pain, mental/mood changes (such as||
1069|102|S|confusion), yellowing eyes/skin.||
1069|103|S|   A very serious allergic reaction to this drug is rare.||
1069|104|S|However, get medical help right away if you notice any symptoms||
1069|105|S|of a serious allergic reaction, including: rash, itching/swelling||
1069|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1069|107|S|breathing.||
1069|108|S|   This is not a complete list of possible side effects. If you||
1069|109|S|notice other effects not listed above, contact your doctor or||
1069|110|S|pharmacist.||
1069|111|S|   In the US -||
1069|112|S|   Call your doctor for medical advice about side effects. You||
1069|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1069|114|S|www.fda.gov/medwatch.||
1069|115|S|   In Canada - Call your doctor for medical advice about side||
1069|116|S|effects. You may report side effects to Health Canada at||
1069|117|S|1-866-234-2345.||
1069|118|B|||
1069|119|P|PRECAUTIONS:  Before using cidofovir, tell your doctor or||
1069|120|P|pharmacist if you are allergic to it; or to other antivirals||
1069|121|P|(such as ganciclovir); or to probenecid; or to other sulfa drugs||
1069|122|P|(such as sulfamethoxazole); or if you have any other allergies.||
1069|123|P|This product may contain inactive ingredients, which can cause||
1069|124|P|allergic reactions or other problems. Talk to your pharmacist for||
1069|125|P|more details.||
1069|126|P|   Before using this medication, tell your doctor or pharmacist||
1069|127|P|your medical history, especially of: diabetes, ganciclovir eye||
1069|128|P|implant, kidney disease.||
1069|129|P|   This drug may cause vision changes. Do not drive, use||
1069|130|P|machinery, or do anything that needs clear vision until you can||
1069|131|P|do it safely. Limit alcoholic beverages.||
1069|132|P|   Older adults may be at a greater risk for kidney damage while||
1069|133|P|using this drug.||
1069|134|P|   During pregnancy, cidofovir should be used only when clearly||
1069|135|P|needed. It may harm an unborn baby. Discuss the risks and||
1069|136|P|benefits with your doctor. The manufacturer recommends avoiding||
1069|137|P|pregnancy. To prevent pregnancy, men with female partners should||
1069|138|P|use effective barrier protections (such as latex or polyurethane||
1069|139|P|condoms) during all sexual activity during treatment and for at||
1069|140|P|least 90 days after stopping the medication. Women should use||
1069|141|P|effective forms of birth control (such as birth control pills and||
1069|142|P|condoms) during treatment and for at least 1 month after stopping||
1069|143|P|the medication.||
1069|144|P|   It is unknown if this medication passes into breast milk. If||
1069|145|P|you have HIV, breast milk may transmit HIV. Consult your doctor||
1069|146|P|before breastfeeding.||
1069|147|B|||
1069|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1069|149|I|medications work or increase your risk for serious side effects.||
1069|150|I|This document does not contain all possible drug interactions.||
1069|151|I|Keep a list of all the products you use (including||
1069|152|I|prescription/nonprescription drugs and herbal products) and share||
1069|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
1069|154|I|the dosage of any medicines without your doctor's approval.||
1069|155|I|   Avoid taking other medications that may damage your kidneys||
1069|156|I|(such as amphotericin B, foscarnet, pentamidine, vancomycin,||
1069|157|I|aminoglycosides including tobramycin, nonsteroidal||
1069|158|I|anti-inflammatory drugs-NSAIDs including ibuprofen) within 7 days||
1069|159|I|before and during treatment with this medication. In some cases,||
1069|160|I|serious (possibly fatal) kidney damage may occur. See also||
1069|161|I|Warning section.||
1069|162|I|   Check the labels on all your medicines because they may||
1069|163|I|contain NSAIDs (such as ibuprofen, naproxen). Ask your pharmacist||
1069|164|I|about using those products safely.||
1069|165|B|||
1069|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1069|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1069|168|O|poison control center right away. US residents can call||
1069|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1069|170|O|Symptoms of overdose may include: change in the amount of urine.||
1069|171|B|||
1069|172|N|NOTES:  Lab and/or medical tests (such as eye exams) should be||
1069|173|N|done while you are using this medication. Keep all medical and||
1069|174|N|lab appointments. Consult your doctor for more details.||
1069|175|N|   To decrease your risk of spreading HIV disease to others, use||
1069|176|N|an effective barrier method (such as latex or polyurethane||
1069|177|N|condoms/dental dams) during sexual activity. Consult your doctor||
1069|178|N|or pharmacist for more details.||
1069|179|B|||
1069|180|D|MISSED DOSE:  It is important to get each dose of this medication||
1069|181|D|as scheduled. If you miss a dose of cidofovir, ask your doctor or||
1069|182|D|pharmacist right away for a new dosing schedule. Do not double||
1069|183|D|the dose to catch up. If you miss a dose of the probenecid, tell||
1069|184|D|your doctor or pharmacist right away. You may have to reschedule||
1069|185|D|your cidofovir dose.||
1069|186|B|||
1069|187|R|STORAGE:  Consult the product instructions and your pharmacist||
1069|188|R|for storage details. Keep all medications away from children and||
1069|189|R|pets.||
1069|190|R|   Do not flush medications down the toilet or pour them into a||
1069|191|R|drain unless instructed to do so. Properly discard this product||
1069|192|R|when it is expired or no longer needed. Consult your pharmacist||
1069|193|R|or local waste disposal company.||
1069|194|B|||
1069|195|A|Information last revised April 2025.||
1069|196|A|Copyright(c) 2025 First Databank, Inc.||
1069|197|B|||
1071|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1071|002|Z|does NOT have all possible information about this product. This||
1071|003|Z|information does not assure that this product is safe, effective,||
1071|004|Z|or appropriate for you. This information is not individual||
1071|005|Z|medical advice and does not substitute for the advice of your||
1071|006|Z|health care professional. Always ask your health care||
1071|007|Z|professional for complete information about this product and your||
1071|008|Z|specific health needs.||
1071|009|B|||
1071|010|T|SULFAMETHOXAZOLE/TRIMETHOPRIM SUSPENSION - ORAL||
1071|011|F|(sull-fuh-meth-OX-uh-zole/try-METH-oh-prim)||
1071|012|B|||
1071|013|C|COMMON BRAND NAME(S): Septra||
1071|014|B|||
1071|015|U|USES:  This medication is a combination of two antibiotics:||
1071|016|U|sulfamethoxazole and trimethoprim. It is used to treat a wide||
1071|017|U|variety of bacterial infections (such as middle ear, urine,||
1071|018|U|respiratory, and intestinal infections). It is also used to||
1071|019|U|prevent and treat a certain type of pneumonia||
1071|020|U|(pneumocystis-type).||
1071|021|U|   This medication should not be used by children less than 2||
1071|022|U|months of age due to the risk of serious side effects.||
1071|023|U|   This medication treats only certain types of infections. It||
1071|024|U|will not work for viral infections (such as flu). Unnecessary use||
1071|025|U|or misuse of any antibiotic can lead to its decreased||
1071|026|U|effectiveness.||
1071|027|B|||
1071|028|H|HOW TO USE:  Shake this medication well before each dose.||
1071|029|H|Carefully measure the dose using a special measuring||
1071|030|H|device/spoon. Do not use a household spoon because you may not||
1071|031|H|get the correct dose. Take this medication by mouth with a full||
1071|032|H|glass of water (8 ounces / 240 milliliters) as directed by your||
1071|033|H|doctor. If stomach upset occurs, take with food or milk. Drink||
1071|034|H|plenty of fluids while taking this medication to lower the||
1071|035|H|unlikely risk of kidney stones forming, unless your doctor||
1071|036|H|advises you otherwise. The dosage is based on your medical||
1071|037|H|condition and response to treatment.||
1071|038|H|   For the best effect, take this antibiotic at evenly spaced||
1071|039|H|times. To help you remember, take this medication at the same||
1071|040|H|time(s) every day.||
1071|041|H|   Continue to take this medication until the full prescribed||
1071|042|H|amount is finished, even if symptoms disappear after a few days.||
1071|043|H|Stopping the medication too early may result in a return of the||
1071|044|H|infection.||
1071|045|H|   Tell your doctor if your condition lasts or gets worse.||
1071|046|B|||
1071|047|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, and loss of appetite||
1071|048|S|may occur. If any of these effects last or get worse, tell your||
1071|049|S|doctor or pharmacist promptly.||
1071|050|S|   Remember that this medication has been prescribed because your||
1071|051|S|doctor has judged that the benefit to you is greater than the||
1071|052|S|risk of side effects. Many people using this medication do not||
1071|053|S|have serious side effects.||
1071|054|S|   Tell your doctor right away if you have any serious side||
1071|055|S|effects, including: muscle weakness, mental/mood changes, signs||
1071|056|S|of kidney problems (such as change in the amount of urine, blood||
1071|057|S|in the urine), extreme drowsiness, signs of low blood sugar (such||
1071|058|S|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
1071|059|S|vision, dizziness, or tingling hands/feet).||
1071|060|S|   Get medical help right away if you have any very serious side||
1071|061|S|effects, including: headache that doesn't go away, neck||
1071|062|S|stiffness, seizures, slow/irregular heartbeat.||
1071|063|S|   This medication may rarely cause a severe intestinal condition||
1071|064|S|due to a bacteria called C. difficile. This condition may occur||
1071|065|S|during treatment or weeks to months after treatment has stopped.||
1071|066|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1071|067|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1071|068|S|stool.||
1071|069|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1071|070|S|products because they may make symptoms worse.||
1071|071|S|   Use of this medication for prolonged or repeated periods may||
1071|072|S|result in oral thrush or a new yeast infection. Contact your||
1071|073|S|doctor if you notice white patches in your mouth, a change in||
1071|074|S|vaginal discharge, or other new symptoms.||
1071|075|S|   This medication may rarely cause serious (possibly fatal)||
1071|076|S|allergic reactions and other side effects such as a severe||
1071|077|S|peeling skin rash (such as Stevens-Johnson syndrome), blood||
1071|078|S|disorders (such as agranulocytosis, aplastic anemia), liver||
1071|079|S|damage, or lung injury. If you notice any of the following, get||
1071|080|S|medical help right away: sore throat or fever that doesn't go||
1071|081|S|away, cough that doesn't go away, nausea/vomiting that doesn't||
1071|082|S|stop, skin rash/blisters, itching/swelling (especially of the||
1071|083|S|face/tongue/throat), new or worsening lymph node swelling, severe||
1071|084|S|dizziness, paleness, chest pain, joint pain/aches, trouble||
1071|085|S|breathing, easy bleeding/bruising, yellowing eyes/skin, unusual||
1071|086|S|tiredness, dark urine.||
1071|087|S|   This is not a complete list of possible side effects. If you||
1071|088|S|notice other effects not listed above, contact your doctor or||
1071|089|S|pharmacist.||
1071|090|S|   In the US -||
1071|091|S|   Call your doctor for medical advice about side effects. You||
1071|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1071|093|S|www.fda.gov/medwatch.||
1071|094|S|   In Canada - Call your doctor for medical advice about side||
1071|095|S|effects. You may report side effects to Health Canada at||
1071|096|S|1-866-234-2345.||
1071|097|B|||
1071|098|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1071|099|P|pharmacist if you are allergic to sulfamethoxazole or||
1071|100|P|trimethoprim; or to sulfa medications; or if you have any other||
1071|101|P|allergies. This product may contain inactive ingredients, which||
1071|102|P|can cause allergic reactions or other problems. Talk to your||
1071|103|P|pharmacist for more details.||
1071|104|P|   Before using this medication, tell your doctor or pharmacist||
1071|105|P|your medical history, especially of: kidney disease, liver||
1071|106|P|disease, certain blood disorders (such as porphyria, anemia due||
1071|107|P|to folate vitamin deficiency), history of blood disorders caused||
1071|108|P|by trimethoprim or sulfa medications, vitamin deficiency (folate||
1071|109|P|or folic acid), severe allergies, asthma, decreased bone marrow||
1071|110|P|function (bone marrow suppression), a certain metabolic disorder||
1071|111|P|(G6PD deficiency), underactive thyroid, mineral imbalances (such||
1071|112|P|as high level of potassium or low level of sodium in the blood).||
1071|113|P|   This medication may cause live bacterial vaccines (such as||
1071|114|P|typhoid vaccine) to not work well. Tell your health care||
1071|115|P|professional that you are using this medication before having any||
1071|116|P|immunizations/vaccinations.||
1071|117|P|   Before having surgery, tell your doctor or dentist about all||
1071|118|P|the products you use (including prescription drugs,||
1071|119|P|nonprescription drugs, and herbal products).||
1071|120|P|   This medication may make you more sensitive to the sun. Limit||
1071|121|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1071|122|P|sunscreen and wear protective clothing when outdoors. Get medical||
1071|123|P|help right away if you get sunburned or have skin||
1071|124|P|blisters/redness.||
1071|125|P|   If you have diabetes, this product may affect your blood||
1071|126|P|sugar. Check your blood sugar regularly as directed and share the||
1071|127|P|results with your doctor. Tell your doctor right away if you have||
1071|128|P|symptoms of low blood sugar (see Side Effects section). Your||
1071|129|P|doctor may need to adjust your diabetes medication, exercise||
1071|130|P|program, or diet.||
1071|131|P|   Older adults may be more sensitive to the side effects of this||
1071|132|P|drug, especially skin reactions, blood disorders, easy||
1071|133|P|bleeding/bruising, and a high potassium blood level.||
1071|134|P|   Patients with AIDS may be more sensitive to the side effects||
1071|135|P|of this drug, especially skin reactions, fever, and blood||
1071|136|P|disorders.||
1071|137|P|   Tell your doctor if you are pregnant or plan to become||
1071|138|P|pregnant. You should not become pregnant while using||
1071|139|P|sulfamethoxazole/trimethoprim. This medication may harm an unborn||
1071|140|P|baby. If you become pregnant, talk to your doctor right away||
1071|141|P|about the risks and benefits of this medication.||
1071|142|P|   This drug passes into breast milk. This drug may have||
1071|143|P|undesirable effects on infants who are ill or premature or have||
1071|144|P|certain disorders (jaundice, high blood levels of bilirubin, G6PD||
1071|145|P|deficiency). Breastfeeding is not recommended for infants with||
1071|146|P|these conditions. Consult your doctor before breastfeeding.||
1071|147|B|||
1071|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1071|149|I|medications work or increase your risk for serious side effects.||
1071|150|I|This document does not contain all possible drug interactions.||
1071|151|I|Keep a list of all the products you use (including||
1071|152|I|prescription/nonprescription drugs and herbal products) and share||
1071|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
1071|154|I|the dosage of any medicines without your doctor's approval.||
1071|155|I|   Some products that may interact with this drug include: "blood||
1071|156|I|thinners" (such as warfarin), dofetilide, methenamine,||
1071|157|I|methotrexate.||
1071|158|I|   This medication may interfere with certain lab tests, possibly||
1071|159|I|causing false test results. Make sure lab personnel and all your||
1071|160|I|doctors know you use this drug.||
1071|161|B|||
1071|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1071|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1071|164|O|poison control center right away. US residents can call||
1071|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1071|166|O|Symptoms of overdose may include: severe||
1071|167|O|nausea/vomiting/diarrhea, severe dizziness or drowsiness,||
1071|168|O|mental/mood changes.||
1071|169|B|||
1071|170|N|NOTES:  Do not share this medication with others.||
1071|171|N|   This medication has been prescribed for your current condition||
1071|172|N|only. Do not use it later for another infection unless your||
1071|173|N|doctor tells you to.||
1071|174|N|   If taking this medication for a long time, lab and/or medical||
1071|175|N|tests (such as complete blood count, kidney function, potassium||
1071|176|N|blood level, cultures) should be done while you are taking this||
1071|177|N|medication. Keep all medical and lab appointments. Consult your||
1071|178|N|doctor for more details.||
1071|179|B|||
1071|180|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1071|181|D|remember. If it is near the time of the next dose, skip the||
1071|182|D|missed dose. Take your next dose at the regular time. Do not||
1071|183|D|double the dose to catch up.||
1071|184|B|||
1071|185|R|STORAGE:  Store at room temperature away from light. Keep all||
1071|186|R|medications away from children and pets.||
1071|187|R|   Do not flush medications down the toilet or pour them into a||
1071|188|R|drain unless instructed to do so. Properly discard this product||
1071|189|R|when it is expired or no longer needed. Consult your pharmacist||
1071|190|R|or local waste disposal company.||
1071|191|B|||
1071|192|A|Information last revised May 2025.||
1071|193|A|Copyright(c) 2025 First Databank, Inc.||
1071|194|B|||
1072|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1072|002|Z|does NOT have all possible information about this product. This||
1072|003|Z|information does not assure that this product is safe, effective,||
1072|004|Z|or appropriate for you. This information is not individual||
1072|005|Z|medical advice and does not substitute for the advice of your||
1072|006|Z|health care professional. Always ask your health care||
1072|007|Z|professional for complete information about this product and your||
1072|008|Z|specific health needs.||
1072|009|B|||
1072|010|T|NEBIVOLOL - ORAL||
1072|011|F|(ne-BIV-oh-lol)||
1072|012|B|||
1072|013|C|COMMON BRAND NAME(S): Bystolic||
1072|014|B|||
1072|015|W|WARNING:  Do not stop taking this medication without consulting||
1072|016|W|your doctor. Some conditions may become worse when you suddenly||
1072|017|W|stop this drug. Some people who have suddenly stopped taking||
1072|018|W|similar drugs have had chest pain, heart attack, and irregular||
1072|019|W|heartbeat. If your doctor decides you should no longer use this||
1072|020|W|drug, your doctor may direct you to gradually decrease your dose||
1072|021|W|over 1 to 2 weeks.||
1072|022|W|   When gradually stopping this medication, it is recommended||
1072|023|W|that you temporarily limit physical activity to decrease strain||
1072|024|W|on the heart. Get medical help right away if you develop chest||
1072|025|W|pain/tightness/pressure, chest pain spreading to the||
1072|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
1072|027|W|fast/irregular heartbeat.||
1072|028|B|||
1072|029|U|USES:  Nebivolol is used to treat high blood pressure. Lowering||
1072|030|U|high blood pressure helps prevent strokes, heart attacks, and||
1072|031|U|kidney problems.||
1072|032|U|   This medication belongs to a class of drugs known as beta||
1072|033|U|blockers. It works by blocking the action of certain natural||
1072|034|U|substances in your body, such as epinephrine, on the heart and||
1072|035|U|blood vessels. This effect lowers heart rate, blood pressure, and||
1072|036|U|strain on the heart.||
1072|037|B|||
1072|038|V|OTHER USES:  This section contains uses of this drug that are not||
1072|039|V|listed in the approved professional labeling for the drug but||
1072|040|V|that may be prescribed by your health care professional. Use this||
1072|041|V|drug for a condition that is listed in this section only if it||
1072|042|V|has been so prescribed by your health care professional.||
1072|043|V|   This drug may also be used after a heart attack to improve||
1072|044|V|survival. It may also be used to reduce the risk of chest pain||
1072|045|V|(angina).||
1072|046|B|||
1072|047|H|HOW TO USE:  See also Warning section.||
1072|048|H|   Read the Patient Information Leaflet if available from your||
1072|049|H|pharmacist before you start taking nebivolol and each time you||
1072|050|H|get a refill. If you have any questions, ask your doctor or||
1072|051|H|pharmacist.||
1072|052|H|   Take this medication by mouth with or without food as directed||
1072|053|H|by your doctor, usually once daily. The dosage is based on your||
1072|054|H|medical condition and response to treatment.||
1072|055|H|   Use this medication regularly to get the most benefit from it.||
1072|056|H|To help you remember, take it at the same time each day.||
1072|057|H|   It may take several weeks before you get the full benefit of||
1072|058|H|this drug. Keep taking this medication even if you feel well.||
1072|059|H|Most people with high blood pressure do not feel sick.||
1072|060|H|   Tell your doctor if your condition does not get better or if||
1072|061|H|it gets worse (your blood pressure readings remain high or||
1072|062|H|increase).||
1072|063|B|||
1072|064|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
1072|065|S|   Headache, dizziness, lightheadedness, tiredness, nausea, slow||
1072|066|S|heartbeat, or trouble sleeping may occur. If any of these effects||
1072|067|S|last or get worse, tell your doctor or pharmacist promptly.||
1072|068|S|   To reduce the risk of dizziness and lightheadedness, get up||
1072|069|S|slowly when rising from a sitting or lying position.||
1072|070|S|   This drug may reduce blood flow to your hands and feet,||
1072|071|S|causing them to feel cold. Smoking may worsen this effect. Dress||
1072|072|S|warmly and avoid tobacco use.||
1072|073|S|   Remember that this medication has been prescribed because your||
1072|074|S|doctor has judged that the benefit to you is greater than the||
1072|075|S|risk of side effects. Many people using this medication do not||
1072|076|S|have serious side effects.||
1072|077|S|   Tell your doctor right away if you have any serious side||
1072|078|S|effects, including: blue fingers/toes, fainting, very slow||
1072|079|S|heartbeat, new or worsening symptoms of heart failure (such as||
1072|080|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
1072|081|S|unusual/sudden weight gain), mental/mood changes (such as||
1072|082|S|confusion, mood swings, depression).||
1072|083|S|   A very serious allergic reaction to this drug is rare.||
1072|084|S|However, get medical help right away if you notice any symptoms||
1072|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1072|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1072|087|S|breathing.||
1072|088|S|   This is not a complete list of possible side effects. If you||
1072|089|S|notice other effects not listed above, contact your doctor or||
1072|090|S|pharmacist.||
1072|091|S|   In the US -||
1072|092|S|   Call your doctor for medical advice about side effects. You||
1072|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1072|094|S|www.fda.gov/medwatch.||
1072|095|S|   In Canada - Call your doctor for medical advice about side||
1072|096|S|effects. You may report side effects to Health Canada at||
1072|097|S|1-866-234-2345.||
1072|098|B|||
1072|099|P|PRECAUTIONS:  Before taking nebivolol, tell your doctor or||
1072|100|P|pharmacist if you are allergic to it; or if you have any other||
1072|101|P|allergies. This product may contain inactive ingredients, which||
1072|102|P|can cause allergic reactions or other problems. Talk to your||
1072|103|P|pharmacist for more details.||
1072|104|P|   Before using this medication, tell your doctor or pharmacist||
1072|105|P|your medical history, especially of: certain types of heart||
1072|106|P|rhythm problems (such as a slow heartbeat, second- or||
1072|107|P|third-degree atrioventricular block), blood circulation problems||
1072|108|P|(such as Raynaud's disease, peripheral vascular disease),||
1072|109|P|breathing problems (such as asthma, chronic bronchitis,||
1072|110|P|emphysema), kidney disease, liver disease, heart failure,||
1072|111|P|mental/mood disorders (such as depression), a certain muscle||
1072|112|P|disease (myasthenia gravis), overactive thyroid disease||
1072|113|P|(hyperthyroidism), serious allergic reactions, including those||
1072|114|P|needing treatment with epinephrine.||
1072|115|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1072|116|P|can make you more dizzy. Do not drive, use machinery, or do||
1072|117|P|anything that needs alertness until you can do it safely. Limit||
1072|118|P|alcoholic beverages. Talk to your doctor if you are using||
1072|119|P|marijuana (cannabis).||
1072|120|P|   Before having surgery, tell your doctor or dentist about all||
1072|121|P|the products you use (including prescription drugs,||
1072|122|P|nonprescription drugs, and herbal products).||
1072|123|P|   This product may prevent the fast/pounding heartbeat you would||
1072|124|P|usually feel when your blood sugar level falls too low||
1072|125|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
1072|126|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
1072|127|P|blood sugar level, such as dizziness and sweating, are not||
1072|128|P|affected by this drug.||
1072|129|P|   If you have diabetes, this product may make it harder to||
1072|130|P|control your blood sugar levels. Check your blood sugar levels||
1072|131|P|regularly as directed by your doctor. Tell your doctor right away||
1072|132|P|if you have symptoms of high blood sugar such as increased||
1072|133|P|thirst/urination. Your doctor may need to adjust your diabetes||
1072|134|P|medication, exercise program, or diet.||
1072|135|P|   Children may be at greater risk for low blood sugar||
1072|136|P|(hypoglycemia) while using this drug, especially if they are||
1072|137|P|vomiting or not eating regularly. To help prevent low blood||
1072|138|P|sugar, make sure children eat regularly. If your child cannot eat||
1072|139|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
1072|140|P|as sweating, shaking), tell the doctor right away.||
1072|141|P|   During pregnancy, this medication should be used only when||
1072|142|P|clearly needed. Babies born to mothers taking this drug during||
1072|143|P|pregnancy may have a low birth weight and require monitoring for||
1072|144|P|problems such as low blood pressure, slow heartbeat, low blood||
1072|145|P|sugar, and slow/shallow breathing. Discuss the risks and benefits||
1072|146|P|with your doctor.||
1072|147|P|   It is unknown if this medication passes into breast milk.||
1072|148|P|Consult your doctor before breastfeeding.||
1072|149|B|||
1072|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1072|151|I|medications work or increase your risk for serious side effects.||
1072|152|I|This document does not contain all possible drug interactions.||
1072|153|I|Keep a list of all the products you use (including||
1072|154|I|prescription/nonprescription drugs and herbal products) and share||
1072|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
1072|156|I|the dosage of any medicines without your doctor's approval.||
1072|157|I|   A product that may interact with this drug is: fingolimod.||
1072|158|I|   Some products have ingredients that could raise your heart||
1072|159|I|rate or blood pressure. Tell your pharmacist what products you||
1072|160|I|are using, and ask how to use them safely (especially||
1072|161|I|cough-and-cold products, diet aids, or NSAIDs such as||
1072|162|I|ibuprofen/naproxen).||
1072|163|B|||
1072|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1072|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1072|166|O|poison control center right away. US residents can call||
1072|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1072|168|O|Symptoms of overdose may include: unusually slow heartbeat,||
1072|169|O|fainting.||
1072|170|B|||
1072|171|N|NOTES:  Do not share this medication with others.||
1072|172|N|   Talk with your doctor about making changes to your lifestyle||
1072|173|N|that may help this medication work better (such as stress||
1072|174|N|reduction programs, exercise, and dietary changes).||
1072|175|N|   Check your blood pressure and pulse (heart rate) regularly||
1072|176|N|while taking this medication. Learn how to check your blood||
1072|177|N|pressure and pulse at home, and share the results with your||
1072|178|N|doctor.||
1072|179|B|||
1072|180|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1072|181|D|remember. If it is near the time of the next dose, skip the||
1072|182|D|missed dose. Take your next dose at the regular time. Do not||
1072|183|D|double the dose to catch up.||
1072|184|B|||
1072|185|R|STORAGE:  Store at room temperature away from light and moisture.||
1072|186|R|Do not store in the bathroom. Keep all medications away from||
1072|187|R|children and pets.||
1072|188|R|   Do not flush medications down the toilet or pour them into a||
1072|189|R|drain unless instructed to do so. Properly discard this product||
1072|190|R|when it is expired or no longer needed. Consult your pharmacist||
1072|191|R|or local waste disposal company.||
1072|192|B|||
1072|193|A|Information last revised May 2024.||
1072|194|A|Copyright(c) 2025 First Databank, Inc.||
1072|195|B|||
1073|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1073|002|Z|does NOT have all possible information about this product. This||
1073|003|Z|information does not assure that this product is safe, effective,||
1073|004|Z|or appropriate for you. This information is not individual||
1073|005|Z|medical advice and does not substitute for the advice of your||
1073|006|Z|health care professional. Always ask your health care||
1073|007|Z|professional for complete information about this product and your||
1073|008|Z|specific health needs.||
1073|009|B|||
1073|010|T|BENDAMUSTINE - INJECTION||
1073|011|F|(BEN-da-MUS-teen)||
1073|012|B|||
1073|013|C|COMMON BRAND NAME(S): Bendeka, Treanda||
1073|014|B|||
1073|015|U|USES:  This medication is used to treat certain types of cancer.||
1073|016|U|Bendamustine belongs to a class of cancer chemotherapy drugs||
1073|017|U|known as alkylating agents. It works by killing cancer cells or||
1073|018|U|slowing their growth.||
1073|019|B|||
1073|020|H|HOW TO USE:  This medication is injected slowly into a vein by a||
1073|021|H|health care professional as directed by your doctor.||
1073|022|H|   The dosage is based on your medical condition, body size, and||
1073|023|H|response to treatment. Before each cycle, you should have blood||
1073|024|H|tests to find the best dose for you and to see whether you need||
1073|025|H|to wait before receiving this drug again.||
1073|026|H|   Infusion reactions may happen during the infusion of this||
1073|027|H|drug. Your doctor may prescribe other medications (including a||
1073|028|H|fever reducer, an antihistamine, a corticosteroid such as||
1073|029|H|dexamethasone) to help prevent these side effects. Tell your||
1073|030|H|doctor right away if you have any symptoms of infusion reactions||
1073|031|H|such as fever or chills.||
1073|032|H|   If bendamustine leaks out of the vein into the surrounding||
1073|033|H|area, it may cause serious skin and tissue damage. Tell your||
1073|034|H|health care professional right away if you experience pain,||
1073|035|H|irritation, redness, or swelling at the injection site. Prompt||
1073|036|H|treatment of the leakage will help reduce discomfort and possible||
1073|037|H|skin damage.||
1073|038|B|||
1073|039|S|SIDE EFFECTS:  See also How to Use section.||
1073|040|S|   Nausea, vomiting, diarrhea, tiredness, headache, dizziness,||
1073|041|S|weakness, or mouth sores may occur. If these effects last or get||
1073|042|S|worse, tell your doctor or pharmacist promptly.||
1073|043|S|   People using this medication may have serious side effects.||
1073|044|S|However, you have been prescribed this drug because your doctor||
1073|045|S|has judged that the benefit to you is greater than the risk of||
1073|046|S|side effects. Careful monitoring by your doctor may decrease your||
1073|047|S|risk.||
1073|048|S|   Tell your doctor right away if you have any serious side||
1073|049|S|effects, including: unusual tiredness, pale skin, easy||
1073|050|S|bruising/bleeding, swelling ankles/feet/hands, unusual skin||
1073|051|S|changes, signs of liver disease (such as nausea/vomiting that||
1073|052|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
1073|053|S|eyes/skin, dark urine).||
1073|054|S|   This medication may lower your ability to fight infections.||
1073|055|S|This may make you more likely to get a serious (rarely fatal)||
1073|056|S|infection or make any infection you have worse. Get medical help||
1073|057|S|right away if you have any signs of infections (such as a sore||
1073|058|S|throat that doesn't go away, fever, chills, swollen lymph nodes).||
1073|059|S|   Bendamustine sometimes causes side effects due to the rapid||
1073|060|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1073|061|S|risk, your doctor may add a medication and tell you to drink||
1073|062|S|plenty of fluids. Tell your doctor right away if you have||
1073|063|S|symptoms such as: low back/side pain (flank pain), signs of||
1073|064|S|kidney problems (such as painful urination, pink/bloody urine,||
1073|065|S|change in the amount of urine), muscle spasms/weakness.||
1073|066|S|   This medication may increase your risk of getting a rare but||
1073|067|S|very serious (possibly fatal) brain infection (progressive||
1073|068|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1073|069|S|if you have any of these side effects: clumsiness, loss of||
1073|070|S|coordination/balance, weakness, sudden change in your thinking||
1073|071|S|(such as confusion, difficulty concentrating, memory loss),||
1073|072|S|difficulty talking/walking, seizure, vision changes.||
1073|073|S|   Some people treated with this medication may rarely get other||
1073|074|S|cancers (such as skin cancer). Consult your doctor for more||
1073|075|S|details.||
1073|076|S|   Bendamustine can commonly cause a rash that is usually not||
1073|077|S|serious. However, you may not be able to tell it apart from a||
1073|078|S|rare rash that could be a sign of a severe reaction. Get medical||
1073|079|S|help right away if you develop any rash.||
1073|080|S|   A very serious allergic reaction to this drug is rare.||
1073|081|S|However, get medical help right away if you notice any symptoms||
1073|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1073|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1073|084|S|breathing.||
1073|085|S|   This is not a complete list of possible side effects. If you||
1073|086|S|notice other effects not listed above, contact your doctor or||
1073|087|S|pharmacist promptly.||
1073|088|S|   In the US -||
1073|089|S|   Call your doctor for medical advice about side effects. You||
1073|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1073|091|S|www.fda.gov/medwatch.||
1073|092|S|   In Canada - Call your doctor for medical advice about side||
1073|093|S|effects. You may report side effects to Health Canada at||
1073|094|S|1-866-234-2345.||
1073|095|B|||
1073|096|P|PRECAUTIONS:  Before using bendamustine, tell your doctor or||
1073|097|P|pharmacist if you are allergic to it; or if you have any other||
1073|098|P|allergies. This product may contain inactive ingredients (such as||
1073|099|P|mannitol), which can cause allergic reactions or other problems.||
1073|100|P|Talk to your pharmacist for more details.||
1073|101|P|   Before using this medication, tell your doctor or pharmacist||
1073|102|P|your medical history, especially of: blood/bone marrow disorders,||
1073|103|P|kidney problems, liver problems, recent/current infection.||
1073|104|P|   Bendamustine can make you more likely to get infections or may||
1073|105|P|make current infections worse. Stay away from anyone who has an||
1073|106|P|infection that may easily spread (such as chickenpox, COVID-19,||
1073|107|P|measles, flu). Talk to your doctor if you have been exposed to an||
1073|108|P|infection or for more details.||
1073|109|P|   Tell your health care professional that you are using||
1073|110|P|bendamustine before having any immunizations/vaccinations. Avoid||
1073|111|P|contact with people who have recently received live vaccines||
1073|112|P|(such as flu vaccine inhaled through the nose).||
1073|113|P|   To lower the chance of getting cut, bruised, or injured, use||
1073|114|P|caution with sharp objects like razors and nail cutters, and||
1073|115|P|avoid activities such as contact sports.||
1073|116|P|   This drug may make you dizzy or tired. Alcohol or marijuana||
1073|117|P|(cannabis) can make you more dizzy or tired. Do not drive, use||
1073|118|P|machinery, or do anything that needs alertness until you can do||
1073|119|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1073|120|P|are using marijuana (cannabis).||
1073|121|P|   This medication can affect fertility in males. Ask your doctor||
1073|122|P|for more details.||
1073|123|P|   Tell your doctor if you are pregnant or plan to become||
1073|124|P|pregnant. You should not become pregnant while using||
1073|125|P|bendamustine. Bendamustine may harm an unborn baby. Your doctor||
1073|126|P|should order a pregnancy test before you start this medication.||
1073|127|P|Men and women using this medication should ask about reliable||
1073|128|P|forms of birth control during treatment and for some time after||
1073|129|P|the last dose. If you or your partner becomes pregnant, talk to||
1073|130|P|your doctor right away about the risks and benefits of this||
1073|131|P|medication.||
1073|132|P|   It is unknown if this drug passes into breast milk. Because of||
1073|133|P|the possible risk to the infant, breastfeeding is not recommended||
1073|134|P|while using this drug and for 1 week after the last dose. Consult||
1073|135|P|your doctor before breastfeeding.||
1073|136|B|||
1073|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1073|138|I|medications work or increase your risk for serious side effects.||
1073|139|I|This document does not contain all possible drug interactions.||
1073|140|I|Keep a list of all the products you use (including||
1073|141|I|prescription/nonprescription drugs and herbal products) and share||
1073|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
1073|143|I|the dosage of any medicines without your doctor's approval.||
1073|144|I|   Some products that may interact with this drug include:||
1073|145|I|idelalisib, other drugs that weaken the immune system/increase||
1073|146|I|the risk of infection (such as natalizumab, rituximab).||
1073|147|B|||
1073|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1073|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1073|150|O|poison control center right away. US residents can call||
1073|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1073|152|O|Symptoms of overdose may include fast/irregular heartbeat and||
1073|153|O|fainting.||
1073|154|B|||
1073|155|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1073|156|N|liver/kidney function, skin exams) should be done while you are||
1073|157|N|using this medication. Keep all medical and lab appointments.||
1073|158|N|Consult your doctor for more details.||
1073|159|B|||
1073|160|D|MISSED DOSE:  It is important to get each dose of this medication||
1073|161|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1073|162|D|right away for a new dosing schedule.||
1073|163|B|||
1073|164|R|STORAGE:  Not applicable. This medication is given in a clinic||
1073|165|R|and will not be stored at home.||
1073|166|B|||
1073|167|M|MEDICAL ALERT:  Your condition can cause complications in a||
1073|168|M|medical emergency. For information about enrolling in MedicAlert,||
1073|169|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1073|170|B|||
1073|171|A|Information last revised May 2025.||
1073|172|A|Copyright(c) 2025 First Databank, Inc.||
1073|173|B|||
1074|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1074|002|Z|does NOT have all possible information about this product. This||
1074|003|Z|information does not assure that this product is safe, effective,||
1074|004|Z|or appropriate for you. This information is not individual||
1074|005|Z|medical advice and does not substitute for the advice of your||
1074|006|Z|health care professional. Always ask your health care||
1074|007|Z|professional for complete information about this product and your||
1074|008|Z|specific health needs.||
1074|009|B|||
1074|010|T|CREATINE - ORAL||
1074|011|F|(kree-AT-in)||
1074|012|B|||
1074|013|U|USES:  Creatine has been used mainly for improving exercise||
1074|014|U|performance and increasing muscle strength.||
1074|015|U|   It has also been used for muscle disorders (such as McArdle's||
1074|016|U|disease), Parkinson's disease, and heart failure. Using this||
1074|017|U|product without proper medical care for conditions such as heart||
1074|018|U|failure may cause or worsen serious health problems. Consult your||
1074|019|U|doctor for proper treatment of your condition.||
1074|020|U|   Creatine is the same as a substance made by your body that is||
1074|021|U|found mostly in the muscles. It helps to provide energy to the||
1074|022|U|muscles.||
1074|023|U|   Some herbal/diet supplement products have been found to||
1074|024|U|contain possibly harmful impurities/additives. Check with your||
1074|025|U|pharmacist for more details about the brand you use.||
1074|026|U|   The FDA has not reviewed this product for safety or||
1074|027|U|effectiveness. Consult your doctor or pharmacist for more||
1074|028|U|details.||
1074|029|B|||
1074|030|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
1074|031|H|directions and warnings on the product package. If you have any||
1074|032|H|questions, ask your doctor or pharmacist.||
1074|033|H|   If you are taking the liquid form, carefully measure the dose||
1074|034|H|using a special measuring device/spoon. Do not use a household||
1074|035|H|spoon because you may not get the correct dose.||
1074|036|H|   If you are taking the chewable form of this product, chew it||
1074|037|H|thoroughly before swallowing.||
1074|038|H|   Drink plenty of water while using this product unless your||
1074|039|H|doctor directs you otherwise.||
1074|040|H|   If your condition lasts or gets worse, or if you think you may||
1074|041|H|have a serious medical problem, get medical help right away.||
1074|042|B|||
1074|043|S|SIDE EFFECTS:  Nausea, upset stomach, or diarrhea may occur. If||
1074|044|S|any of these effects last or get worse, tell your doctor or||
1074|045|S|pharmacist promptly.||
1074|046|S|   Tell your doctor right away if you have any serious side||
1074|047|S|effects, including: muscle cramps, reduced ability to tolerate||
1074|048|S|heat, symptoms of dehydration (such as unusual decreased||
1074|049|S|urination, unusual dry mouth/thirst, fast heartbeat,||
1074|050|S|dizziness/lightheadedness), signs of kidney problems (such as||
1074|051|S|change in the amount of urine).||
1074|052|S|   Get medical help right away if you have any very serious side||
1074|053|S|effects, including: seizures.||
1074|054|S|   A very serious allergic reaction to this product is rare.||
1074|055|S|However, get medical help right away if you notice any symptoms||
1074|056|S|of a serious allergic reaction, including: rash, itching/swelling||
1074|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1074|058|S|breathing.||
1074|059|S|   This is not a complete list of possible side effects. If you||
1074|060|S|notice other effects not listed above, contact your doctor or||
1074|061|S|pharmacist.||
1074|062|S|   In the US -||
1074|063|S|   Call your doctor for medical advice about side effects. You||
1074|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1074|065|S|www.fda.gov/medwatch.||
1074|066|S|   In Canada - Call your doctor for medical advice about side||
1074|067|S|effects. You may report side effects to Health Canada at||
1074|068|S|1-866-234-2345.||
1074|069|B|||
1074|070|P|PRECAUTIONS:  Before taking creatine, tell your doctor or||
1074|071|P|pharmacist if you are allergic to it; or if you have any other||
1074|072|P|allergies. This product may contain inactive ingredients, which||
1074|073|P|can cause allergic reactions or other problems. Talk to your||
1074|074|P|pharmacist for more details.||
1074|075|P|   Before using this product, tell your doctor or pharmacist your||
1074|076|P|medical history, especially of: kidney disease, liver disease,||
1074|077|P|diabetes.||
1074|078|P|   Liquid forms of this product may contain sugar and/or alcohol.||
1074|079|P|Caution is advised if you have diabetes, alcohol dependence, or||
1074|080|P|liver disease. Ask your doctor or pharmacist about using this||
1074|081|P|product safely.||
1074|082|P|   Children may be more sensitive to the effects of this product.||
1074|083|P|   This product is not recommended for use during pregnancy.||
1074|084|P|Consult your doctor for more details.||
1074|085|P|   It is unknown if this product passes into breast milk. Because||
1074|086|P|of the possible risk to the infant, breastfeeding is not||
1074|087|P|recommended while using this product. Consult your doctor before||
1074|088|P|breastfeeding.||
1074|089|B|||
1074|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1074|091|I|medications work or increase your risk for serious side effects.||
1074|092|I|This document does not contain all possible drug interactions.||
1074|093|I|Keep a list of all the products you use (including||
1074|094|I|prescription/nonprescription drugs and herbal products) and share||
1074|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
1074|096|I|the dosage of any medicines without your doctor's approval.||
1074|097|I|   Some drugs that may interact with this product are: drugs that||
1074|098|I|may harm the kidneys (including NSAIDs such as||
1074|099|I|ibuprofen/naproxen), "water pills" (diuretics such as||
1074|100|I|hydrochlorothiazide).||
1074|101|I|   This product may interfere with certain lab tests (such as||
1074|102|I|kidney function tests), possibly causing false test results. Make||
1074|103|I|sure lab personnel and all your doctors know you use this||
1074|104|I|product.||
1074|105|B|||
1074|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1074|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1074|108|O|poison control center right away. US residents can call||
1074|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1074|110|B|||
1074|111|N|NOTES:  Lab and/or medical tests (such as kidney function) may be||
1074|112|N|done while you are taking this product. Keep all medical and lab||
1074|113|N|appointments. Consult your doctor for more details.||
1074|114|B|||
1074|115|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1074|116|D|remember. If it is near the time of the next dose, skip the||
1074|117|D|missed dose. Take your next dose at the regular time. Do not||
1074|118|D|double the dose to catch up.||
1074|119|B|||
1074|120|R|STORAGE:  Refer to storage information printed on the package. If||
1074|121|R|you have any questions about storage, ask your pharmacist. Keep||
1074|122|R|all medications and herbal products away from children and pets.||
1074|123|R|   Do not flush medications down the toilet or pour them into a||
1074|124|R|drain unless instructed to do so. Properly discard this product||
1074|125|R|when it is expired or no longer needed. Consult your pharmacist||
1074|126|R|or local waste disposal company.||
1074|127|B|||
1074|128|A|Information last revised August 2025.||
1074|129|A|Copyright(c) 2025 First Databank, Inc.||
1074|130|B|||
1075|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1075|002|Z|does NOT have all possible information about this product. This||
1075|003|Z|information does not assure that this product is safe, effective,||
1075|004|Z|or appropriate for you. This information is not individual||
1075|005|Z|medical advice and does not substitute for the advice of your||
1075|006|Z|health care professional. Always ask your health care||
1075|007|Z|professional for complete information about this product and your||
1075|008|Z|specific health needs.||
1075|009|B|||
1075|010|T|QUINAPRIL - ORAL||
1075|011|F|(KWIN-a-pril)||
1075|012|B|||
1075|013|C|COMMON BRAND NAME(S): Accupril||
1075|014|B|||
1075|015|W|WARNING:  Quinapril can cause serious (possibly fatal) harm to an||
1075|016|W|unborn baby if used during pregnancy. It is important to prevent||
1075|017|W|pregnancy while taking this medication. Consult your doctor for||
1075|018|W|more details and to discuss the use of reliable forms of birth||
1075|019|W|control while taking this medication. If you are planning||
1075|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
1075|021|W|your doctor right away.||
1075|022|B|||
1075|023|U|USES:  Quinapril is used to treat high blood pressure. Lowering||
1075|024|U|high blood pressure helps prevent strokes, heart attacks, and||
1075|025|U|kidney problems. This medication is also used to treat heart||
1075|026|U|failure. Quinapril belongs to a class of drugs known as ACE||
1075|027|U|inhibitors. It works by relaxing blood vessels so blood can flow||
1075|028|U|more easily.||
1075|029|B|||
1075|030|V|OTHER USES:  This section contains uses of this drug that are not||
1075|031|V|listed in the approved professional labeling for the drug but||
1075|032|V|that may be prescribed by your health care professional. Use this||
1075|033|V|drug for a condition that is listed in this section only if it||
1075|034|V|has been so prescribed by your health care professional.||
1075|035|V|   This medication may also be used for kidney disease and to||
1075|036|V|help protect the kidneys from harm due to diabetes.||
1075|037|B|||
1075|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1075|039|H|from your pharmacist before you start taking quinapril and each||
1075|040|H|time you get a refill. If you have any questions, ask your doctor||
1075|041|H|or pharmacist.||
1075|042|H|   Take this medication by mouth with or without food as directed||
1075|043|H|by your doctor, usually once or twice a day. High-fat meals may||
1075|044|H|decrease the absorption of this medication.||
1075|045|H|   To reduce your risk of side effects, your doctor may direct||
1075|046|H|you to start this medication at a low dose and gradually increase||
1075|047|H|your dose. Follow your doctor's instructions carefully.||
1075|048|H|   The dosage is based on your medical condition and response to||
1075|049|H|treatment.||
1075|050|H|   Take this medication regularly to get the most benefit from||
1075|051|H|it. To help you remember, take it at the same time(s) each day.||
1075|052|H|Keep taking this medication even if you feel well. Most people||
1075|053|H|with high blood pressure do not feel sick.||
1075|054|H|   For the treatment of high blood pressure, it may take 1 to 2||
1075|055|H|weeks before you get the full benefit of this medication. For the||
1075|056|H|treatment of heart failure, it may take weeks to months before||
1075|057|H|you get the full benefit of this medication.||
1075|058|H|   This product contains magnesium which may interfere with the||
1075|059|H|absorption of some medications. See the Drug Interactions section||
1075|060|H|and consult your pharmacist for more information.||
1075|061|H|   Tell your doctor if your condition does not get better or if||
1075|062|H|it gets worse (for example, your blood pressure readings remain||
1075|063|H|high or increase).||
1075|064|B|||
1075|065|S|SIDE EFFECTS:  Dizziness, lightheadedness, or tiredness may occur||
1075|066|S|as your body adjusts to the medication. Dry cough, nausea, or||
1075|067|S|vomiting may also occur. If any of these effects last or get||
1075|068|S|worse, tell your doctor or pharmacist promptly.||
1075|069|S|   Remember that this medication has been prescribed because your||
1075|070|S|doctor has judged that the benefit to you is greater than the||
1075|071|S|risk of side effects. Many people using this medication do not||
1075|072|S|have serious side effects.||
1075|073|S|   Tell your doctor right away if you have any serious side||
1075|074|S|effects, including: symptoms of a high potassium blood level||
1075|075|S|(such as muscle weakness, slow/irregular heartbeat), fainting.||
1075|076|S|   Although quinapril may be used to prevent kidney problems or||
1075|077|S|treat people who have kidney problems, it may also rarely cause||
1075|078|S|serious kidney problems or make them worse. Your doctor will||
1075|079|S|check your kidney function while you are taking quinapril. Tell||
1075|080|S|your doctor right away if you have any signs of kidney problems||
1075|081|S|such as a change in the amount of urine.||
1075|082|S|   This drug may rarely cause serious (possibly fatal) liver||
1075|083|S|problems. Get medical help right away if you have any symptoms of||
1075|084|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1075|085|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1075|086|S|urine.||
1075|087|S|   A very serious allergic reaction to this drug is rare.||
1075|088|S|However, get medical help right away if you notice any symptoms||
1075|089|S|of a serious allergic reaction, including: rash, itching/swelling||
1075|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1075|091|S|breathing.||
1075|092|S|   This is not a complete list of possible side effects. If you||
1075|093|S|notice other effects not listed above, contact your doctor or||
1075|094|S|pharmacist.||
1075|095|S|   In the US -||
1075|096|S|   Call your doctor for medical advice about side effects. You||
1075|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1075|098|S|www.fda.gov/medwatch.||
1075|099|S|   In Canada - Call your doctor for medical advice about side||
1075|100|S|effects. You may report side effects to Health Canada at||
1075|101|S|1-866-234-2345.||
1075|102|B|||
1075|103|P|PRECAUTIONS:  Before taking quinapril, tell your doctor or||
1075|104|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
1075|105|P|(such as benazepril); or if you have any other allergies. This||
1075|106|P|product may contain inactive ingredients, which can cause||
1075|107|P|allergic reactions or other problems. Talk to your pharmacist for||
1075|108|P|more details.||
1075|109|P|   Before using this medication, tell your doctor or pharmacist||
1075|110|P|your medical history, especially of: history of an allergic||
1075|111|P|reaction which included swelling of the face/lips/tongue/throat||
1075|112|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
1075|113|P|dialysis), high level of potassium in the blood, liver disease.||
1075|114|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1075|115|P|can make you more dizzy. Do not drive, use machinery, or do||
1075|116|P|anything that needs alertness until you can do it safely. Limit||
1075|117|P|alcoholic beverages. Talk to your doctor if you are using||
1075|118|P|marijuana (cannabis).||
1075|119|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1075|120|P|and cause you to feel lightheaded. Tell your doctor if you have||
1075|121|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1075|122|P|of fluids unless your doctor tells you not to.||
1075|123|P|   Before having surgery, tell your doctor or dentist about all||
1075|124|P|the products you use (including prescription drugs,||
1075|125|P|nonprescription drugs, and herbal products).||
1075|126|P|   This product may increase your potassium levels. Before using||
1075|127|P|potassium supplements or salt substitutes that contain potassium,||
1075|128|P|consult your doctor or pharmacist.||
1075|129|P|   Older adults may be more sensitive to the side effects of this||
1075|130|P|drug, including dizziness and increases in potassium level.||
1075|131|P|   Tell your doctor if you are pregnant or plan to become||
1075|132|P|pregnant. You should not become pregnant while using quinapril.||
1075|133|P|Quinapril may harm an unborn baby. If you become pregnant, talk||
1075|134|P|to your doctor right away about the risks and benefits of this||
1075|135|P|medication. (See also Warning section.)||
1075|136|P|   This medication passes into breast milk. Consult your doctor||
1075|137|P|before breastfeeding.||
1075|138|B|||
1075|139|I|DRUG INTERACTIONS:  See also Precautions section.||
1075|140|I|   Drug interactions may change how your medications work or||
1075|141|I|increase your risk for serious side effects. This document does||
1075|142|I|not contain all possible drug interactions. Keep a list of all||
1075|143|I|the products you use (including prescription/nonprescription||
1075|144|I|drugs and herbal products) and share it with your doctor and||
1075|145|I|pharmacist. Do not start, stop, or change the dosage of any||
1075|146|I|medicines without your doctor's approval.||
1075|147|I|   Some products that may interact with this drug include:||
1075|148|I|aliskiren, gold injections, lithium, sacubitril, certain drugs||
1075|149|I|that weaken the immune system/increase the risk of infection||
1075|150|I|(such as everolimus, sirolimus), drugs that may increase the||
1075|151|I|level of potassium in the blood (such as ARBs including||
1075|152|I|losartan/valsartan, birth control pills containing drospirenone).||
1075|153|I|   This product contains magnesium which can interfere with your||
1075|154|I|body's ability to absorb certain drugs, especially if you take||
1075|155|I|them around the same time. These drugs include quinolone||
1075|156|I|antibiotics (such as ciprofloxacin, levofloxacin), tetracycline||
1075|157|I|antibiotics (such as doxycycline, minocycline), thyroid||
1075|158|I|medications (such as levothyroxine), and drugs for osteoporosis||
1075|159|I|(bisphosphonates such as alendronate). This is not a complete||
1075|160|I|list. Ask your doctor or pharmacist how long to wait between||
1075|161|I|doses and when you should take your medications.||
1075|162|I|   Some products have ingredients that could raise your blood||
1075|163|I|pressure or worsen your heart failure. Tell your pharmacist what||
1075|164|I|products you are using, and ask how to use them safely||
1075|165|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
1075|166|I|ibuprofen/naproxen).||
1075|167|I|   A very serious reaction may occur if you are getting||
1075|168|I|injections for bee/wasp sting allergy (desensitization) and are||
1075|169|I|also taking quinapril. Make sure all your doctors know which||
1075|170|I|medicines you are using.||
1075|171|B|||
1075|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1075|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1075|174|O|poison control center right away. US residents can call||
1075|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1075|176|O|Symptoms of overdose may include: severe dizziness, fainting.||
1075|177|B|||
1075|178|N|NOTES:  Do not share this medication with others.||
1075|179|N|   Lifestyle changes that may help this medication work better||
1075|180|N|include exercising, stopping smoking, and eating a||
1075|181|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1075|182|N|details.||
1075|183|N|   Lab and/or medical tests (such as kidney function, potassium||
1075|184|N|levels) should be done while you are taking this medication. Keep||
1075|185|N|all medical and lab appointments. Consult your doctor for more||
1075|186|N|details.||
1075|187|N|   Check your blood pressure and pulse (heart rate) regularly||
1075|188|N|while taking this medication. Learn how to check your own blood||
1075|189|N|pressure and pulse at home, and share the results with your||
1075|190|N|doctor.||
1075|191|B|||
1075|192|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1075|193|D|remember. If it is near the time of the next dose, skip the||
1075|194|D|missed dose. Take your next dose at the regular time. Do not||
1075|195|D|double the dose to catch up.||
1075|196|B|||
1075|197|R|STORAGE:  Store at room temperature away from light and moisture.||
1075|198|R|Do not store in the bathroom. Keep all medications away from||
1075|199|R|children and pets.||
1075|200|R|   Do not flush medications down the toilet or pour them into a||
1075|201|R|drain unless instructed to do so. Properly discard this product||
1075|202|R|when it is expired or no longer needed. Consult your pharmacist||
1075|203|R|or local waste disposal company.||
1075|204|B|||
1075|205|A|Information last revised May 2024.||
1075|206|A|Copyright(c) 2025 First Databank, Inc.||
1075|207|B|||
1077|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1077|002|Z|does NOT have all possible information about this product. This||
1077|003|Z|information does not assure that this product is safe, effective,||
1077|004|Z|or appropriate for you. This information is not individual||
1077|005|Z|medical advice and does not substitute for the advice of your||
1077|006|Z|health care professional. Always ask your health care||
1077|007|Z|professional for complete information about this product and your||
1077|008|Z|specific health needs.||
1077|009|B|||
1077|010|T|ETRAVIRINE - ORAL||
1077|011|F|(et-ra-VIR-een)||
1077|012|B|||
1077|013|C|COMMON BRAND NAME(S): Intelence||
1077|014|B|||
1077|015|U|USES:  Etravirine is used with other HIV medications to help||
1077|016|U|control HIV infection. It helps to decrease the amount of HIV in||
1077|017|U|your body so your immune system can work better. This lowers your||
1077|018|U|chance of getting HIV complications (such as new infections,||
1077|019|U|cancer) and improves your quality of life. This medication is||
1077|020|U|usually prescribed to people who have taken other HIV medications||
1077|021|U|(such as efavirenz, nevirapine, delavirdine) that did not work||
1077|022|U|well enough to control their HIV. Etravirine is known as a||
1077|023|U|non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks||
1077|024|U|the virus from growing and infecting more cells.||
1077|025|U|   Etravirine is not a cure for HIV infection. To decrease your||
1077|026|U|risk of spreading HIV disease to others, continue to take all HIV||
1077|027|U|medications exactly as prescribed by your doctor. Use an||
1077|028|U|effective barrier method (latex or polyurethane condoms/dental||
1077|029|U|dams) during sexual activity as directed by your doctor. Do not||
1077|030|U|share personal items (such as needles/syringes, toothbrushes, and||
1077|031|U|razors) that may have contacted blood or other body fluids.||
1077|032|U|Consult your doctor or pharmacist for more details.||
1077|033|B|||
1077|034|V|OTHER USES:  This section contains uses of this drug that are not||
1077|035|V|listed in the approved professional labeling for the drug but||
1077|036|V|that may be prescribed by your health care professional. Use this||
1077|037|V|drug for a condition that is listed in this section only if it||
1077|038|V|has been so prescribed by your health care professional.||
1077|039|V|   This product may also be used to lessen the risk of HIV||
1077|040|V|infection after contact with the virus (for example, due to a||
1077|041|V|needle stick). Ask your doctor for more details.||
1077|042|B|||
1077|043|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1077|044|H|from your pharmacist before you start using etravirine and each||
1077|045|H|time you get a refill. If you have any questions, ask your doctor||
1077|046|H|or pharmacist.||
1077|047|H|   Take this medication by mouth after a meal as directed by your||
1077|048|H|doctor, usually 2 times daily. Swallow the medication whole. Do||
1077|049|H|not crush, chew, or split the tablets.||
1077|050|H|   Children's dosage is based on weight.||
1077|051|H|   If you have trouble swallowing this medication whole, you may||
1077|052|H|place your dose in a glass with about 1 teaspoonful (5||
1077|053|H|milliliters) of water to dissolve the tablet. If needed, add more||
1077|054|H|water to cover the tablet. Stir the mixture well until it looks||
1077|055|H|milky. Use only water to first dissolve the tablet. Then add||
1077|056|H|about 1 tablespoonful (15 milliliters) of water, orange juice, or||
1077|057|H|milk to the glass and drink all of it right away. Rinse the glass||
1077|058|H|with more water, orange juice, or milk and drink all of it. Rinse||
1077|059|H|and drink several times to make sure you have taken the whole||
1077|060|H|dose. You should not mix the drug with warm or carbonated drinks.||
1077|061|H|   It is very important to keep taking this medication (and other||
1077|062|H|HIV medications) exactly as prescribed by your doctor. Do not||
1077|063|H|increase your dose or take this medication more often than||
1077|064|H|prescribed. Your condition will not improve any faster, and the||
1077|065|H|risk of serious side effects may be increased.||
1077|066|H|   Do not take less of this drug than prescribed or stop taking||
1077|067|H|it (or other HIV medicines) even for a short time unless directed||
1077|068|H|to do so by your doctor. Doing so may cause the amount of virus||
1077|069|H|to increase and/or make the infection more difficult to treat||
1077|070|H|(resistant).||
1077|071|H|   For the best effect, take this medication at evenly spaced||
1077|072|H|times. To help you remember, take this medication at the same||
1077|073|H|times every day.||
1077|074|B|||
1077|075|S|SIDE EFFECTS:  Nausea may occur. If this effect lasts or gets||
1077|076|S|worse, tell your doctor or pharmacist promptly.||
1077|077|S|   Remember that this medication has been prescribed because your||
1077|078|S|doctor has judged that the benefit to you is greater than the||
1077|079|S|risk of side effects. Many people using this medication do not||
1077|080|S|have serious side effects.||
1077|081|S|   As your immune system gets stronger, it can begin to fight off||
1077|082|S|infections you already had, possibly causing disease symptoms to||
1077|083|S|come back. You could also have symptoms if your immune system||
1077|084|S|becomes overactive. This reaction may happen at any time (soon||
1077|085|S|after starting HIV treatment or many months later). Tell your||
1077|086|S|doctor right away if you have any serious symptoms, including:||
1077|087|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1077|088|S|that doesn't go away, headaches that are severe or don't go away,||
1077|089|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1077|090|S|changes, signs of infection (such as sore throat that doesn't go||
1077|091|S|away, fever, chills, non-healing skin sores), signs of an||
1077|092|S|overactive thyroid (such as irritability, nervousness, heat||
1077|093|S|intolerance, fast/pounding/irregular heartbeat), signs of liver||
1077|094|S|disease (such as nausea/vomiting that doesn't stop, loss of||
1077|095|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1077|096|S|urine).||
1077|097|S|   Tell your doctor right away if you have any serious side||
1077|098|S|effects, including: increased thirst/urination, signs of kidney||
1077|099|S|problems (such as change in the amount of urine), mental/mood||
1077|100|S|changes (such as nervousness, confusion), seizures.||
1077|101|S|   Get medical help right away if you have any very serious side||
1077|102|S|effects, including: chest/jaw/left arm pain.||
1077|103|S|   Changes in body fat may occur while you are taking this||
1077|104|S|medication (such as increased fat in the upper back and stomach||
1077|105|S|areas, decreased fat in the arms and legs). The cause and||
1077|106|S|long-term effects of these changes are unknown. Discuss the risks||
1077|107|S|and benefits of treatment with your doctor, as well as the||
1077|108|S|possible role of exercise to reduce this side effect.||
1077|109|S|   A very serious allergic reaction to this drug is rare.||
1077|110|S|However, get medical help right away if you notice any symptoms||
1077|111|S|of a serious allergic reaction, including: swollen lymph nodes,||
1077|112|S|rash, itching/swelling (especially of the face/tongue/throat),||
1077|113|S|severe dizziness, trouble breathing.||
1077|114|S|   Etravirine can commonly cause a mild rash that is usually not||
1077|115|S|serious. The rash usually occurs during the second week of||
1077|116|S|treatment and goes away in 1 to 2 weeks. However, you may not be||
1077|117|S|able to tell it apart from a rare rash that could be a sign of a||
1077|118|S|severe allergic reaction. Get medical help right away if you||
1077|119|S|develop any rash, especially with symptoms such as fever,||
1077|120|S|tiredness, muscle/joint pain, blisters, mouth sores, or||
1077|121|S|red/swollen eyes.||
1077|122|S|   This is not a complete list of possible side effects. If you||
1077|123|S|notice other effects not listed above, contact your doctor or||
1077|124|S|pharmacist.||
1077|125|S|   In the US -||
1077|126|S|   Call your doctor for medical advice about side effects. You||
1077|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1077|128|S|www.fda.gov/medwatch.||
1077|129|S|   In Canada - Call your doctor for medical advice about side||
1077|130|S|effects. You may report side effects to Health Canada at||
1077|131|S|1-866-234-2345.||
1077|132|B|||
1077|133|P|PRECAUTIONS:  Before taking etravirine, tell your doctor or||
1077|134|P|pharmacist if you are allergic to it; or if you have any other||
1077|135|P|allergies. This product may contain inactive ingredients, which||
1077|136|P|can cause allergic reactions or other problems. Talk to your||
1077|137|P|pharmacist for more details.||
1077|138|P|   Before using this medication, tell your doctor or pharmacist||
1077|139|P|your medical history, especially of: liver disease (such as||
1077|140|P|hepatitis B, hepatitis C).||
1077|141|P|   Before having surgery, tell your doctor or dentist about all||
1077|142|P|the products you use (including prescription drugs,||
1077|143|P|nonprescription drugs, and herbal products).||
1077|144|P|   Children may be more sensitive to the side effects of this||
1077|145|P|drug, especially rash.||
1077|146|P|   Tell your doctor if you are pregnant before using this||
1077|147|P|medication. Treatment can lower the risk of passing HIV infection||
1077|148|P|to your baby. Discuss the risks and benefits with your doctor.||
1077|149|P|   This medication passes into breast milk. Because breast milk||
1077|150|P|may transmit HIV, consult your doctor before breastfeeding.||
1077|151|B|||
1077|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1077|153|I|medications work or increase your risk for serious side effects.||
1077|154|I|This document does not contain all possible drug interactions.||
1077|155|I|Keep a list of all the products you use (including||
1077|156|I|prescription/nonprescription drugs and herbal products) and share||
1077|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
1077|158|I|the dosage of any medicines without your doctor's approval.||
1077|159|I|   A product that may interact with this drug is: orlistat.||
1077|160|I|   Make sure your doctor is aware of all the HIV drugs you are||
1077|161|I|taking. This medication may interact with other HIV medications.||
1077|162|I|Your doctor may need to change your treatment or monitor you more||
1077|163|I|closely if you are taking a certain combination of HIV||
1077|164|I|medications. Consult your doctor or pharmacist for more details.||
1077|165|I|   Other medications can affect the removal of etravirine from||
1077|166|I|your body, which may affect how etravirine works. Examples||
1077|167|I|include macrolide antibiotics (such as erythromycin,||
1077|168|I|clarithromycin), rifamycins (such as rifabutin, rifampin,||
1077|169|I|rifapentine), St. John's wort, drugs used to treat seizures (such||
1077|170|I|as carbamazepine, phenobarbital, phenytoin, primidone), among||
1077|171|I|others.||
1077|172|I|   This medication can speed up or slow down the removal of other||
1077|173|I|medications from your body, which may affect how they work.||
1077|174|I|Examples of affected drugs include clopidogrel, cobicistat,||
1077|175|I|medications for heart rhythm (such as amiodarone, disopyramide),||
1077|176|I|"blood thinners" (such as warfarin), certain "statin" cholesterol||
1077|177|I|medications (atorvastatin, fluvastatin, lovastatin, simvastatin),||
1077|178|I|drugs to treat erectile dysfunction-ED or pulmonary hypertension||
1077|179|I|(such as sildenafil, tadalafil), among others.||
1077|180|B|||
1077|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1077|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1077|183|O|poison control center right away. US residents can call||
1077|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1077|185|B|||
1077|186|N|NOTES:  Do not share this medication with others.||
1077|187|N|   Lab and/or medical tests (such as viral load, T-cell counts)||
1077|188|N|should be done while you are taking this medication. Keep all||
1077|189|N|medical and lab appointments. Consult your doctor for more||
1077|190|N|details.||
1077|191|B|||
1077|192|D|MISSED DOSE:  If you miss a dose, take it after a meal as soon as||
1077|193|D|you remember. If it is more than 6 hours after the missed dose,||
1077|194|D|skip the missed dose. Take your next dose at the regular time. Do||
1077|195|D|not double the dose to catch up.||
1077|196|B|||
1077|197|R|STORAGE:  Store in the original bottle at room temperature away||
1077|198|R|from light and moisture. Do not store in the bathroom. Keep the||
1077|199|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1077|200|R|when not in use. Keep all medications away from children and||
1077|201|R|pets.||
1077|202|R|   Do not flush medications down the toilet or pour them into a||
1077|203|R|drain unless instructed to do so. Properly discard this product||
1077|204|R|when it is expired or no longer needed. Consult your pharmacist||
1077|205|R|or local waste disposal company.||
1077|206|B|||
1077|207|A|Information last revised May 2025.||
1077|208|A|Copyright(c) 2025 First Databank, Inc.||
1077|209|B|||
1080|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1080|002|Z|does NOT have all possible information about this product. This||
1080|003|Z|information does not assure that this product is safe, effective,||
1080|004|Z|or appropriate for you. This information is not individual||
1080|005|Z|medical advice and does not substitute for the advice of your||
1080|006|Z|health care professional. Always ask your health care||
1080|007|Z|professional for complete information about this product and your||
1080|008|Z|specific health needs.||
1080|009|B|||
1080|010|T|BENZPHETAMINE - ORAL||
1080|011|F|(benz-FET-a-meen)||
1080|012|B|||
1080|013|C|COMMON BRAND NAME(S): Didrex||
1080|014|B|||
1080|015|U|USES:  Benzphetamine is used short-term along with a||
1080|016|U|doctor-approved, reduced-calorie diet, exercise, and behavior||
1080|017|U|change program to help you lose weight. It is used in people who||
1080|018|U|are significantly overweight (obese) and have not been able to||
1080|019|U|lose enough weight with diet and exercise alone. Losing weight||
1080|020|U|and keeping it off can reduce the many health risks that come||
1080|021|U|with obesity, including heart disease, diabetes, high blood||
1080|022|U|pressure, and a shorter life.||
1080|023|U|   It is not known how this medication helps people to lose||
1080|024|U|weight. It may work by decreasing your appetite, increasing the||
1080|025|U|amount of energy used by your body, or by affecting certain parts||
1080|026|U|of the brain. This medication is an appetite suppressant and||
1080|027|U|belongs to a class of drugs called sympathomimetic amines.||
1080|028|B|||
1080|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
1080|030|H|doctor, usually 1 to 3 times a day. Taking this medication late||
1080|031|H|in the day may cause trouble sleeping (insomnia).||
1080|032|H|   The dosage is based on your medical condition and response to||
1080|033|H|treatment. Your doctor will adjust the dose to find the best dose||
1080|034|H|for you. Use this medication regularly and exactly as prescribed||
1080|035|H|in order to get the most benefit from it. To help you remember,||
1080|036|H|take it at the same time(s) each day.||
1080|037|H|   Benzphetamine is usually taken for only a few weeks at a time.||
1080|038|H|It should not be taken with other appetite suppressants (see also||
1080|039|H|Drug Interactions section). The possibility of serious side||
1080|040|H|effects increases with longer use of this medication and use of||
1080|041|H|this drug along with certain other diet drugs.||
1080|042|H|   Caffeine can increase the side effects of this medication.||
1080|043|H|Avoid drinking large amounts of beverages containing caffeine||
1080|044|H|(coffee, tea, colas), eating large amounts of chocolate, or||
1080|045|H|taking nonprescription products that contain caffeine.||
1080|046|H|   If you suddenly stop using this medication, you may have||
1080|047|H|withdrawal symptoms (such as depression, severe tiredness). To||
1080|048|H|help prevent withdrawal, your doctor may lower your dose slowly.||
1080|049|H|Withdrawal is more likely if you have used benzphetamine for a||
1080|050|H|long time or in high doses. Tell your doctor or pharmacist right||
1080|051|H|away if you have withdrawal.||
1080|052|H|   Though it helps many people, this medication may sometimes||
1080|053|H|cause addiction. This risk may be higher if you have a substance||
1080|054|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1080|055|H|Do not increase your dose, take it more often, or use it for a||
1080|056|H|longer time than prescribed. Properly stop the medication when so||
1080|057|H|directed.||
1080|058|H|   This medication may stop working well after you have been||
1080|059|H|taking it for a while. Talk with your doctor if this medication||
1080|060|H|stops working well. Do not increase the dose unless directed by||
1080|061|H|your doctor. Your doctor may direct you to stop taking this||
1080|062|H|medication.||
1080|063|B|||
1080|064|S|SIDE EFFECTS:  Dizziness, dry mouth, difficulty sleeping,||
1080|065|S|irritability, nausea, vomiting, diarrhea, or constipation may||
1080|066|S|occur. If these effects last or get worse, notify your doctor or||
1080|067|S|pharmacist promptly.||
1080|068|S|   Remember that this medication has been prescribed because your||
1080|069|S|doctor has judged that the benefit to you is greater than the||
1080|070|S|risk of side effects. Many people using this medication do not||
1080|071|S|have serious side effects.||
1080|072|S|   This medication may raise your blood pressure. Check your||
1080|073|S|blood pressure regularly and tell your doctor if the results are||
1080|074|S|high.||
1080|075|S|   Tell your doctor right away if you have any serious side||
1080|076|S|effects, including: fast/irregular/pounding heartbeat,||
1080|077|S|mental/mood changes (such as agitation, uncontrolled anger,||
1080|078|S|hallucinations, nervousness), uncontrolled muscle movements,||
1080|079|S|change in sexual ability/interest.||
1080|080|S|   Get medical help right away if you have any very serious side||
1080|081|S|effects, including: severe headache, trouble speaking, seizure,||
1080|082|S|weakness on one side of the body, vision changes (such as blurred||
1080|083|S|vision).||
1080|084|S|   This drug may rarely cause serious (sometimes fatal) lung or||
1080|085|S|heart problems (pulmonary hypertension, heart valve problems).||
1080|086|S|The risk increases with longer use of this medication and use of||
1080|087|S|this drug along with other appetite-suppressant drugs/herbal||
1080|088|S|products. If you notice any of the following unlikely but very||
1080|089|S|serious side effects, stop taking this medication and consult||
1080|090|S|your doctor or pharmacist right away: chest pain, difficulty||
1080|091|S|breathing with exercise, decreased ability to exercise, fainting,||
1080|092|S|swelling of the legs/ankles/feet.||
1080|093|S|   A very serious allergic reaction to this drug is rare.||
1080|094|S|However, get medical help right away if you notice any symptoms||
1080|095|S|of a serious allergic reaction, including: rash, itching/swelling||
1080|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1080|097|S|breathing.||
1080|098|S|   This is not a complete list of possible side effects. If you||
1080|099|S|notice other effects not listed above, contact your doctor or||
1080|100|S|pharmacist.||
1080|101|S|   In the US -||
1080|102|S|   Call your doctor for medical advice about side effects. You||
1080|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1080|104|S|www.fda.gov/medwatch.||
1080|105|S|   In Canada - Call your doctor for medical advice about side||
1080|106|S|effects. You may report side effects to Health Canada at||
1080|107|S|1-866-234-2345.||
1080|108|B|||
1080|109|P|PRECAUTIONS:  Before taking benzphetamine, tell your doctor or||
1080|110|P|pharmacist if you are allergic to it; or to any other||
1080|111|P|sympathomimetic amines (including decongestants such as||
1080|112|P|pseudoephedrine, stimulants such as amphetamine, appetite||
1080|113|P|suppressants such as phentermine); or if you have any other||
1080|114|P|allergies. This product may contain inactive ingredients, which||
1080|115|P|can cause allergic reactions or other problems. Talk to your||
1080|116|P|pharmacist for more details.||
1080|117|P|   Before using this medication, tell your doctor or pharmacist||
1080|118|P|your medical history, especially of: heart disease (such as chest||
1080|119|P|pain, heart attack, heart murmur, fast/irregular heartbeat, heart||
1080|120|P|valve problems), high blood pressure, glaucoma, personal or||
1080|121|P|family history of a substance use disorder (such as overuse of or||
1080|122|P|addiction to drugs/alcohol), mental/mood problems (such as severe||
1080|123|P|anxiety, bipolar disorder, psychosis, schizophrenia), high blood||
1080|124|P|pressure in the lungs (pulmonary hypertension), stroke,||
1080|125|P|overactive thyroid (hyperthyroidism), diabetes, kidney disease,||
1080|126|P|seizures.||
1080|127|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1080|128|P|can make you more dizzy. Do not drive, use machinery, or do||
1080|129|P|anything that needs alertness until you can do it safely. Avoid||
1080|130|P|alcoholic beverages. Talk to your doctor if you are using||
1080|131|P|marijuana (cannabis).||
1080|132|P|   If you have diabetes, check your blood sugar regularly as||
1080|133|P|directed and share the results with your doctor. Your doctor may||
1080|134|P|need to adjust your diabetes medication during treatment with||
1080|135|P|this drug.||
1080|136|P|   Before having surgery, tell your doctor or dentist about all||
1080|137|P|the products you use (including prescription drugs,||
1080|138|P|nonprescription drugs, and herbal products).||
1080|139|P|   Older adults may be at greater risk for dizziness and high||
1080|140|P|blood pressure while using this drug.||
1080|141|P|   Benzphetamine must not be used during pregnancy. It may harm||
1080|142|P|an unborn baby. If you become pregnant or think you may be||
1080|143|P|pregnant, inform your doctor right away. Infants born to mothers||
1080|144|P|who have been using this medication for a long time or in high||
1080|145|P|doses may have withdrawal symptoms such as irritability or||
1080|146|P|extreme tiredness. Tell your doctor right away if you notice any||
1080|147|P|of these symptoms in your newborn.||
1080|148|P|   This drug may pass into breast milk and could have undesirable||
1080|149|P|effects on a nursing infant. Breastfeeding is not recommended||
1080|150|P|while using this drug. Consult your doctor before breastfeeding.||
1080|151|B|||
1080|152|I|DRUG INTERACTIONS:  See also How to Use section.||
1080|153|I|   Drug interactions may change how your medications work or||
1080|154|I|increase your risk for serious side effects. This document does||
1080|155|I|not contain all possible drug interactions. Keep a list of all||
1080|156|I|the products you use (including prescription/nonprescription||
1080|157|I|drugs and herbal products) and share it with your doctor and||
1080|158|I|pharmacist. Do not start, stop, or change the dosage of any||
1080|159|I|medicines without your doctor's approval.||
1080|160|I|   Some products that may interact with this drug include:||
1080|161|I|phenothiazines (such as prochlorperazine, chlorpromazine), other||
1080|162|I|stimulants (including amphetamines, methylphenidate, street drugs||
1080|163|I|such as cocaine or MDMA/"ecstasy").||
1080|164|I|   If you are taking or have taken other appetite-suppressant||
1080|165|I|drugs in the past year (such as phentermine, ephedra/ma huang),||
1080|166|I|tell your doctor or pharmacist before starting this medication.||
1080|167|I|   Taking MAO inhibitors with this medication may cause a serious||
1080|168|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1080|169|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1080|170|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1080|171|I|selegiline, tranylcypromine) during treatment with this||
1080|172|I|medication. Most MAO inhibitors should also not be taken for two||
1080|173|I|weeks before treatment with this medication. Ask your doctor when||
1080|174|I|to start or stop taking this medication.||
1080|175|I|   Some products have ingredients that could raise your heart||
1080|176|I|rate or blood pressure. Tell your pharmacist what products you||
1080|177|I|are using, and ask how to use them safely (especially||
1080|178|I|cough-and-cold products or diet aids).||
1080|179|B|||
1080|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1080|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1080|182|O|poison control center right away. US residents can call||
1080|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1080|184|O|Symptoms of overdose may include: rapid breathing, unusual||
1080|185|O|restlessness, fast/slow/irregular heartbeat, chest pain,||
1080|186|O|hallucinations, seizures, loss of consciousness.||
1080|187|B|||
1080|188|N|NOTES:  Do not share this medication with others. Sharing it is||
1080|189|N|against the law.||
1080|190|N|   Appetite suppressants should not be used in place of proper||
1080|191|N|diet. For best results, this drug must be used along with a||
1080|192|N|doctor-approved diet and exercise program.||
1080|193|N|   Lab and/or medical tests (such as blood pressure, heart/kidney||
1080|194|N|function) may be done while you are taking this medication. Keep||
1080|195|N|all medical and lab appointments. Consult your doctor for more||
1080|196|N|details.||
1080|197|B|||
1080|198|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1080|199|D|remember. If it is near the time of the next dose or late in the||
1080|200|D|evening, skip the missed dose. Take your next dose at the regular||
1080|201|D|time. Do not double the dose to catch up.||
1080|202|B|||
1080|203|R|STORAGE:  Store at room temperature away from light and moisture.||
1080|204|R|Keep all medications away from children and pets.||
1080|205|R|   Do not flush medications down the toilet or pour them into a||
1080|206|R|drain unless instructed to do so. Properly discard this product||
1080|207|R|when it is expired or no longer needed. Consult your pharmacist||
1080|208|R|or local waste disposal company.||
1080|209|B|||
1080|210|A|Information last revised July 2025.||
1080|211|A|Copyright(c) 2025 First Databank, Inc.||
1080|212|B|||
1081|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1081|002|Z|does NOT have all possible information about this product. This||
1081|003|Z|information does not assure that this product is safe, effective,||
1081|004|Z|or appropriate for you. This information is not individual||
1081|005|Z|medical advice and does not substitute for the advice of your||
1081|006|Z|health care professional. Always ask your health care||
1081|007|Z|professional for complete information about this product and your||
1081|008|Z|specific health needs.||
1081|009|B|||
1081|010|T|ALISKIREN/HYDROCHLOROTHIAZIDE - ORAL||
1081|011|F|(AL-is-KYE-ren/HYE-droe-KLOR-oh-THYE-a-zide)||
1081|012|B|||
1081|013|C|COMMON BRAND NAME(S): Tekturna HCT||
1081|014|B|||
1081|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
1081|016|W|unborn baby if used during pregnancy. It is important to prevent||
1081|017|W|pregnancy while taking this medication. Consult your doctor for||
1081|018|W|more details and to discuss the use of reliable forms of birth||
1081|019|W|control while taking this medication. If you are planning||
1081|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
1081|021|W|your doctor right away.||
1081|022|B|||
1081|023|U|USES:  This product is used to treat high blood pressure||
1081|024|U|(hypertension). Lowering high blood pressure helps prevent||
1081|025|U|strokes, heart attacks, and kidney problems.||
1081|026|U|   This product contains 2 medications: aliskiren and||
1081|027|U|hydrochlorothiazide. Aliskiren works by relaxing blood vessels so||
1081|028|U|blood can flow more easily. It belongs to a class of drugs known||
1081|029|U|as direct renin inhibitors. Hydrochlorothiazide causes your body||
1081|030|U|to get rid of extra salt and water by making more urine. It is||
1081|031|U|called a "water pill" or diuretic.||
1081|032|B|||
1081|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1081|034|H|from your pharmacist before you start using this product and each||
1081|035|H|time you get a refill. If you have any questions, ask your doctor||
1081|036|H|or pharmacist.||
1081|037|H|   Take this medication by mouth as directed by your doctor,||
1081|038|H|usually once daily. You may take this medication with or without||
1081|039|H|food, but it is important to choose one way and take this||
1081|040|H|medication the same way with every dose. High-fat foods may||
1081|041|H|decrease how well this drug is absorbed by the body, so it is||
1081|042|H|best to avoid taking this medication with a high-fat meal. Also,||
1081|043|H|if you take this drug too close to bedtime, you may need to wake||
1081|044|H|up to urinate. It is best to take this medication at least 4||
1081|045|H|hours before your bedtime.||
1081|046|H|   Do not take with fruit juices (such as apple, grapefruit, or||
1081|047|H|orange) since they may decrease the absorption of this drug.||
1081|048|H|   If you also take certain drugs to lower your cholesterol (bile||
1081|049|H|acid-binding resins such as cholestyramine, colestipol), take||
1081|050|H|aliskiren/hydrochlorothiazide at least 4 hours before or at least||
1081|051|H|4 to 6 hours after these medications.||
1081|052|H|   The dosage is based on your medical condition and response to||
1081|053|H|treatment.||
1081|054|H|   Take this medication regularly to get the most benefit from||
1081|055|H|it. To help you remember, take it at the same time each day. Keep||
1081|056|H|taking this medication even if you feel well. Most people with||
1081|057|H|high blood pressure do not feel sick. It may take up to 4 weeks||
1081|058|H|before you get the full benefit of this drug.||
1081|059|H|   Tell your doctor if your condition does not get better or if||
1081|060|H|it gets worse (your blood pressure readings remain high or||
1081|061|H|increase).||
1081|062|B|||
1081|063|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
1081|064|S|body adjusts to the medication. Dry cough or diarrhea may also||
1081|065|S|occur. If any of these effects last or get worse, tell your||
1081|066|S|doctor or pharmacist promptly.||
1081|067|S|   To reduce the risk of dizziness and lightheadedness, get up||
1081|068|S|slowly when rising from a sitting or lying position.||
1081|069|S|   Remember that this medication has been prescribed because your||
1081|070|S|doctor has judged that the benefit to you is greater than the||
1081|071|S|risk of side effects. Many people using this medication do not||
1081|072|S|have serious side effects.||
1081|073|S|   This product may cause dehydration and electrolyte imbalance.||
1081|074|S|Tell your doctor right away if you have any symptoms of||
1081|075|S|dehydration or electrolyte imbalance, including unusual dry||
1081|076|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
1081|077|S|heartbeat, or confusion.||
1081|078|S|   Tell your doctor right away if you have any serious side||
1081|079|S|effects, including: fainting, severe tiredness, big toe/joint||
1081|080|S|pain, signs of kidney problems (such as change in the amount of||
1081|081|S|urine).||
1081|082|S|   Get medical help right away if you have any very serious side||
1081|083|S|effects, including: decrease in vision, eye pain.||
1081|084|S|   A very serious allergic reaction to this drug is rare.||
1081|085|S|However, get medical help right away if you notice any symptoms||
1081|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1081|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1081|088|S|breathing.||
1081|089|S|   This is not a complete list of possible side effects. If you||
1081|090|S|notice other effects not listed above, contact your doctor or||
1081|091|S|pharmacist.||
1081|092|S|   In the US -||
1081|093|S|   Call your doctor for medical advice about side effects. You||
1081|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1081|095|S|www.fda.gov/medwatch.||
1081|096|S|   In Canada - Call your doctor for medical advice about side||
1081|097|S|effects. You may report side effects to Health Canada at||
1081|098|S|1-866-234-2345.||
1081|099|B|||
1081|100|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1081|101|P|pharmacist if you are allergic to aliskiren or||
1081|102|P|hydrochlorothiazide; or if you have any other allergies. This||
1081|103|P|product may contain inactive ingredients, which can cause||
1081|104|P|allergic reactions or other problems. Talk to your pharmacist for||
1081|105|P|more details.||
1081|106|P|   Before using this medication, tell your doctor or pharmacist||
1081|107|P|your medical history, especially of: diabetes, kidney disease,||
1081|108|P|liver disease, dehydration, untreated electrolytes imbalance||
1081|109|P|(such as high/low potassium, low magnesium, high calcium), gout,||
1081|110|P|lupus, skin cancer.||
1081|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1081|112|P|can make you more dizzy. Do not drive, use machinery, or do||
1081|113|P|anything that needs alertness until you can do it safely. Limit||
1081|114|P|alcoholic beverages. Talk to your doctor if you are using||
1081|115|P|marijuana (cannabis).||
1081|116|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1081|117|P|and cause you to feel lightheaded. Tell your doctor if you have||
1081|118|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1081|119|P|of fluids unless your doctor tells you not to.||
1081|120|P|   If you have diabetes, this product may affect your blood||
1081|121|P|sugar. Check your blood sugar regularly as directed and share the||
1081|122|P|results with your doctor. Your doctor may need to adjust your||
1081|123|P|diabetes medication, exercise program, or diet.||
1081|124|P|   This product may affect your potassium levels. Before using||
1081|125|P|potassium supplements or salt substitutes that contain potassium,||
1081|126|P|consult your doctor or pharmacist.||
1081|127|P|   This medication may make you more sensitive to the sun. It may||
1081|128|P|also increase your risk for skin cancer, especially if you take||
1081|129|P|it for a long time. Limit your time in the sun. Avoid tanning||
1081|130|P|booths and sunlamps. Use sunscreen and wear protective clothing||
1081|131|P|when outdoors. Tell your doctor right away if you get sunburned,||
1081|132|P|have skin blisters/redness, or notice new or changed moles/skin||
1081|133|P|lesions.||
1081|134|P|   Before having surgery, tell your doctor or dentist about all||
1081|135|P|the products you use (including prescription drugs,||
1081|136|P|nonprescription drugs, and herbal products).||
1081|137|P|   Older adults may be more sensitive to the effects of this||
1081|138|P|product, especially dizziness.||
1081|139|P|   Tell your doctor if you are pregnant or plan to become||
1081|140|P|pregnant. You should not become pregnant while using this||
1081|141|P|medication. Aliskiren may harm an unborn baby. If you become||
1081|142|P|pregnant, talk to your doctor right away about the risks and||
1081|143|P|benefits of this medication. See also Warning section.||
1081|144|P|   It is unknown if aliskiren passes into breast milk.||
1081|145|P|Hydrochlorothiazide passes into breast milk. Consult your doctor||
1081|146|P|before breastfeeding.||
1081|147|B|||
1081|148|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
1081|149|I|   Drug interactions may change how your medications work or||
1081|150|I|increase your risk for serious side effects. This document does||
1081|151|I|not contain all possible drug interactions. Keep a list of all||
1081|152|I|the products you use (including prescription/nonprescription||
1081|153|I|drugs and herbal products) and share it with your doctor and||
1081|154|I|pharmacist. Do not start, stop, or change the dosage of any||
1081|155|I|medicines without your doctor's approval.||
1081|156|I|   Some products that may interact with this drug include:||
1081|157|I|dofetilide, lithium, drugs that may increase the level of||
1081|158|I|potassium in the blood (including sparsentan, ACE inhibitors such||
1081|159|I|as benazepril/lisinopril, ARBs such as candesartan/losartan,||
1081|160|I|birth control pills containing drospirenone).||
1081|161|I|   Other medications can affect the removal of aliskiren from||
1081|162|I|your body, which may affect how aliskiren works. Examples include||
1081|163|I|itraconazole, cyclosporine, quinidine, among others.||
1081|164|I|   Some products have ingredients that could raise your blood||
1081|165|I|pressure. Tell your pharmacist what products you are using, and||
1081|166|I|ask how to use them safely (especially cough-and-cold products,||
1081|167|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1081|168|I|   This medication may interfere with certain lab tests, possibly||
1081|169|I|causing false test results. Make sure lab personnel and all your||
1081|170|I|doctors know you use this drug.||
1081|171|B|||
1081|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1081|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1081|174|O|poison control center right away. US residents can call||
1081|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1081|176|O|Symptoms of overdose may include: severe dizziness, fainting.||
1081|177|B|||
1081|178|N|NOTES:  Do not share this medication with others.||
1081|179|N|   Lifestyle changes that may help this medication work better||
1081|180|N|include exercising, stopping smoking, and eating a||
1081|181|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1081|182|N|details.||
1081|183|N|   Lab and/or medical tests (including kidney function, blood||
1081|184|N|mineral levels such as potassium, skin exams, cholesterol levels)||
1081|185|N|should be done while you are taking this medication. Keep all||
1081|186|N|medical and lab appointments.||
1081|187|N|   Have your blood pressure checked regularly while taking this||
1081|188|N|medication. Learn how to monitor your own blood pressure at home,||
1081|189|N|and share the results with your doctor.||
1081|190|B|||
1081|191|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1081|192|D|remember. If it is near the time of the next dose, skip the||
1081|193|D|missed dose. Take your next dose at the regular time. Do not||
1081|194|D|double the dose to catch up.||
1081|195|B|||
1081|196|R|STORAGE:  Store at room temperature away from light and moisture.||
1081|197|R|Do not store in the bathroom. Keep all medications away from||
1081|198|R|children and pets.||
1081|199|R|   Do not flush medications down the toilet or pour them into a||
1081|200|R|drain unless instructed to do so. Properly discard this product||
1081|201|R|when it is expired or no longer needed. Consult your pharmacist||
1081|202|R|or local waste disposal company.||
1081|203|B|||
1081|204|A|Information last revised March 2025.||
1081|205|A|Copyright(c) 2025 First Databank, Inc.||
1081|206|B|||
1083|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1083|002|Z|does NOT have all possible information about this product. This||
1083|003|Z|information does not assure that this product is safe, effective,||
1083|004|Z|or appropriate for you. This information is not individual||
1083|005|Z|medical advice and does not substitute for the advice of your||
1083|006|Z|health care professional. Always ask your health care||
1083|007|Z|professional for complete information about this product and your||
1083|008|Z|specific health needs.||
1083|009|B|||
1083|010|T|KETOTIFEN - ORAL||
1083|011|F|(key-toe-TIFF-en)||
1083|012|B|||
1083|013|U|USES:  Ketotifen is used as a long-term (maintenance) treatment||
1083|014|U|in children to prevent or decrease wheezing and troubled||
1083|015|U|breathing caused by allergic-type asthma. It is usually used||
1083|016|U|along with other medications for asthma (including||
1083|017|U|corticosteroids such as prednisone, inhaled beta agonists such as||
1083|018|U|salbutamol). This medication is an antihistamine. It improves||
1083|019|U|breathing by decreasing swelling and inflammation of the airways||
1083|020|U|in the lungs. Controlling symptoms of asthma can increase the||
1083|021|U|ability to exercise/play and decrease time lost from school.||
1083|022|U|   This medication does not work right away and should not be||
1083|023|U|used for sudden attacks of shortness of breath/asthma. Your||
1083|024|U|doctor must prescribe a quick-relief medicine/inhaler (such as||
1083|025|U|salbutamol, albuterol) for sudden shortness of breath/asthma||
1083|026|U|attacks while you are on this medication. You should always have||
1083|027|U|a quick-relief inhaler with you. Consult your doctor or||
1083|028|U|pharmacist for more details.||
1083|029|B|||
1083|030|H|HOW TO USE:  Take this medication by mouth with or without food||
1083|031|H|as directed by your doctor, usually twice daily. Do not crush or||
1083|032|H|chew the tablets. Doing so may increase side effects.||
1083|033|H|   Dosage is based on your age and response to treatment. Your||
1083|034|H|doctor may start you at a lower dose and slowly adjust the dose||
1083|035|H|to lessen side effects (such as drowsiness). Use this medication||
1083|036|H|regularly to get the most benefit from it. To help you remember,||
1083|037|H|take it at the same times each day.||
1083|038|H|   Do not stop using this medication or change your dose without||
1083|039|H|consulting your doctor. Some conditions may become worse when the||
1083|040|H|drug is suddenly stopped. Your dose may need to be gradually||
1083|041|H|decreased.||
1083|042|H|   This medication does not work right away. It may take 2 to 3||
1083|043|H|months for this medication to have an effect. Your doctor may||
1083|044|H|also adjust the dosage of your other asthma medications while you||
1083|045|H|are taking ketotifen. If you are regularly taking corticosteroids||
1083|046|H|(such as prednisone, fluticasone), you should not stop using||
1083|047|H|them, and you should not replace them with ketotifen. Carefully||
1083|048|H|follow your doctor's directions for taking all your medicines.||
1083|049|B|||
1083|050|S|SIDE EFFECTS:  Drowsiness, increased appetite/weight,||
1083|051|S|irritability, trouble sleeping, and nervousness may occur.||
1083|052|S|Infrequent side effects include temporary dry mouth or slight||
1083|053|S|dizziness. If any of these effects last or get worse, tell your||
1083|054|S|doctor or pharmacist promptly.||
1083|055|S|   Remember that this medication has been prescribed because your||
1083|056|S|doctor has judged that the benefit to you is greater than the||
1083|057|S|risk of side effects. Many people using this medication do not||
1083|058|S|have serious side effects.||
1083|059|S|   Tell your doctor right away if you have any serious side||
1083|060|S|effects, including: easy bruising/bleeding, symptoms of liver||
1083|061|S|disease (such as nausea/vomiting that doesn't stop, dark urine,||
1083|062|S|stomach/abdominal pain, yellowing eyes/skin), urination problems||
1083|063|S|(especially symptoms of frequent/burning/painful urination).||
1083|064|S|   A very serious allergic reaction to this drug is rare.||
1083|065|S|However, get medical help right away if you notice any symptoms||
1083|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1083|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1083|068|S|breathing.||
1083|069|S|   This is not a complete list of possible side effects. If you||
1083|070|S|notice other effects not listed above, contact your doctor or||
1083|071|S|pharmacist.||
1083|072|S|   In the US -||
1083|073|S|   Call your doctor for medical advice about side effects. You||
1083|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1083|075|S|www.fda.gov/medwatch.||
1083|076|S|   In Canada - Call your doctor for medical advice about side||
1083|077|S|effects. You may report side effects to Health Canada at||
1083|078|S|1-866-234-2345.||
1083|079|B|||
1083|080|P|PRECAUTIONS:  Before taking ketotifen, tell your doctor or||
1083|081|P|pharmacist if you are allergic to it; or if you have any other||
1083|082|P|allergies. This product may contain inactive ingredients, which||
1083|083|P|can cause allergic reactions or other problems. Talk to your||
1083|084|P|pharmacist for more details.||
1083|085|P|   Before using this medication, tell your doctor or pharmacist||
1083|086|P|your medical history, especially of: diabetes, seizure disorders||
1083|087|P|(such as epilepsy).||
1083|088|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1083|089|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1083|090|P|machinery, ride a bicycle, or do anything that needs alertness||
1083|091|P|until you can do it safely. Limit alcoholic beverages. Talk to||
1083|092|P|your doctor if you are using marijuana (cannabis).||
1083|093|P|   During pregnancy, this medication should be used only when||
1083|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
1083|095|P|   It is unknown if this medication passes into breast milk.||
1083|096|P|Consult your doctor before breastfeeding.||
1083|097|B|||
1083|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1083|099|I|medications work or increase your risk for serious side effects.||
1083|100|I|This document does not contain all possible drug interactions.||
1083|101|I|Keep a list of all the products you use (including||
1083|102|I|prescription/nonprescription drugs and herbal products) and share||
1083|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
1083|104|I|the dosage of any medicines without your doctor's approval.||
1083|105|I|   Tell your doctor or pharmacist if you are taking other||
1083|106|I|products that cause drowsiness such as opioid pain or cough||
1083|107|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1083|108|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1083|109|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1083|110|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1083|111|I|diphenhydramine).||
1083|112|I|   Check the labels on all your medicines (such as allergy or||
1083|113|I|cough-and-cold products) because they may contain ingredients||
1083|114|I|that cause drowsiness. Ask your pharmacist about using those||
1083|115|I|products safely.||
1083|116|B|||
1083|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1083|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1083|119|O|poison control center right away. US residents can call||
1083|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1083|121|O|Symptoms of overdose may include: unusual drowsiness, confusion,||
1083|122|O|fast heartbeat, fainting, seizures.||
1083|123|B|||
1083|124|N|NOTES:  Do not share this medication with others.||
1083|125|N|   Lab and/or medical tests (such as complete blood count,||
1083|126|N|pulmonary function) may be done while you are taking this||
1083|127|N|medication. Keep all medical and lab appointments. Consult your||
1083|128|N|doctor for more details.||
1083|129|B|||
1083|130|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1083|131|D|remember. If it is near the time of the next dose, skip the||
1083|132|D|missed dose. Take your next dose at the regular time. Do not||
1083|133|D|double the dose to catch up.||
1083|134|B|||
1083|135|R|STORAGE:  Store at room temperature away from light and moisture.||
1083|136|R|Do not store in the bathroom. Keep all medications away from||
1083|137|R|children and pets.||
1083|138|R|   Do not flush medications down the toilet or pour them into a||
1083|139|R|drain unless instructed to do so. Properly discard this product||
1083|140|R|when it is expired or no longer needed. Consult your pharmacist||
1083|141|R|or local waste disposal company.||
1083|142|B|||
1083|143|A|Information last revised May 2024.||
1083|144|A|Copyright(c) 2025 First Databank, Inc.||
1083|145|B|||
1084|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1084|002|Z|does NOT have all possible information about this product. This||
1084|003|Z|information does not assure that this product is safe, effective,||
1084|004|Z|or appropriate for you. This information is not individual||
1084|005|Z|medical advice and does not substitute for the advice of your||
1084|006|Z|health care professional. Always ask your health care||
1084|007|Z|professional for complete information about this product and your||
1084|008|Z|specific health needs.||
1084|009|B|||
1084|010|T|DALTEPARIN VIAL - INJECTION||
1084|011|F|(DAL-te-PAR-in)||
1084|012|B|||
1084|013|C|COMMON BRAND NAME(S): Fragmin||
1084|014|B|||
1084|015|W|WARNING:  People using this medication may bleed near the spinal||
1084|016|W|cord after certain spinal procedures. Bleeding in this area can||
1084|017|W|cause paralysis that lasts a long time or could become permanent.||
1084|018|W|Talk with your doctor about the benefits and risks before any||
1084|019|W|spinal procedure. Your doctor may direct you to stop this||
1084|020|W|medication for a certain amount of time before and after the||
1084|021|W|procedure. Carefully follow your doctor's directions.||
1084|022|W|   The risk of bleeding may be higher if you have a deformed||
1084|023|W|spine, or have had spinal procedures/surgery before (such as||
1084|024|W|epidural catheter placement, difficult epidural/spinal puncture),||
1084|025|W|or are taking other drugs that can cause bleeding/bruising||
1084|026|W|(including antiplatelet drugs such as clopidogrel, "blood||
1084|027|W|thinners" such as warfarin/rivaroxaban, nonsteroidal||
1084|028|W|anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your||
1084|029|W|doctor right away if you notice symptoms such as back pain, leg||
1084|030|W|numbness/tingling/weakness, loss of control of the bowels or||
1084|031|W|bladder (incontinence).||
1084|032|B|||
1084|033|U|USES:  Dalteparin is used to treat and prevent harmful blood||
1084|034|U|clots. Preventing harmful blood clots helps to reduce the risk of||
1084|035|U|a stroke or heart attack. This medication helps keep your blood||
1084|036|U|flowing smoothly by lowering the activity of clotting proteins in||
1084|037|U|the blood. Dalteparin is a type of heparin, and works as an||
1084|038|U|anticoagulant (commonly called a "blood thinner").||
1084|039|U|   Conditions that increase your risk of developing blood clots||
1084|040|U|include certain types of surgeries (such as hip replacement,||
1084|041|U|abdominal surgery), long periods of being in one position||
1084|042|U|(immobile), certain types of heart attack, and a certain type of||
1084|043|U|chest pain called unstable angina. For some medical conditions,||
1084|044|U|dalteparin may be used in combination with other "blood||
1084|045|U|thinners."||
1084|046|U|   Dalteparin may also be used to treat and prevent clots from||
1084|047|U|coming back in patients with cancer.||
1084|048|B|||
1084|049|V|OTHER USES:  This section contains uses of this drug that are not||
1084|050|V|listed in the approved professional labeling for the drug but||
1084|051|V|that may be prescribed by your health care professional. Use this||
1084|052|V|drug for a condition that is listed in this section only if it||
1084|053|V|has been so prescribed by your health care professional.||
1084|054|V|   This drug may also be used to reduce the risk of blood||
1084|055|V|clotting in hemodialysis machines.||
1084|056|B|||
1084|057|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1084|058|H|from your pharmacist before you start using dalteparin and each||
1084|059|H|time you get a refill. If you have any questions, ask your doctor||
1084|060|H|or pharmacist.||
1084|061|H|   Inject this medication under the skin as directed by your||
1084|062|H|doctor, usually once or twice daily. The injection is given in||
1084|063|H|the abdomen or thighs. Do not inject into a muscle. The dosage||
1084|064|H|and length of treatment are based on your medical condition,||
1084|065|H|weight, and response to treatment. This medication may also be||
1084|066|H|given by injection into a vein by a health care professional, as||
1084|067|H|directed by your doctor, for certain conditions.||
1084|068|H|   If you are using this medication at home, learn all||
1084|069|H|preparation and usage instructions from your health care||
1084|070|H|professional and the product package. Before using, check this||
1084|071|H|product for particles or discoloration. If either is present, do||
1084|072|H|not use the liquid. This medication should not be mixed with or||
1084|073|H|added to any other medication. Before injecting each dose, clean||
1084|074|H|the skin you are going to inject into (the injection site) with||
1084|075|H|rubbing alcohol. Change the injection site each time to lessen||
1084|076|H|injury under the skin. To lessen bruising, do not rub the||
1084|077|H|injection site after a shot. Learn how to store and discard||
1084|078|H|medical supplies safely.||
1084|079|H|   To prevent blood clots due to surgery, your doctor may direct||
1084|080|H|you to start using this medication before or after surgery and||
1084|081|H|continue for several days. Follow your doctor's directions||
1084|082|H|closely.||
1084|083|H|   Use this medication regularly to get the most benefit from it.||
1084|084|H|To help you remember, use it at the same time(s) each day.||
1084|085|B|||
1084|086|S|SIDE EFFECTS:  See also Warning section.||
1084|087|S|   Irritation, bruising, and pain at the injection site may||
1084|088|S|occur. If any of these effects last or get worse, tell your||
1084|089|S|doctor or pharmacist promptly.||
1084|090|S|   Remember that this medication has been prescribed because your||
1084|091|S|doctor has judged that the benefit to you is greater than the||
1084|092|S|risk of side effects. Many people using this medication do not||
1084|093|S|have serious side effects.||
1084|094|S|   This medication can cause bleeding if its effect on your blood||
1084|095|S|clotting proteins is too much. Tell your doctor right away if you||
1084|096|S|have any serious signs of bleeding, including: unusual||
1084|097|S|pain/swelling/discomfort, unusual or prolonged bleeding, unusual||
1084|098|S|or easy bruising, dark urine, black stools, severe headache,||
1084|099|S|confusion, vision changes, unusual dizziness, fainting, seizures,||
1084|100|S|weakness, numbness.||
1084|101|S|   A very serious allergic reaction to this drug is rare.||
1084|102|S|However, get medical help right away if you notice any symptoms||
1084|103|S|of a serious allergic reaction, including: rash, itching/swelling||
1084|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1084|105|S|breathing.||
1084|106|S|   This is not a complete list of possible side effects. If you||
1084|107|S|notice other effects not listed above, contact your doctor or||
1084|108|S|pharmacist.||
1084|109|S|   In the US -||
1084|110|S|   Call your doctor for medical advice about side effects. You||
1084|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1084|112|S|www.fda.gov/medwatch.||
1084|113|S|   In Canada - Call your doctor for medical advice about side||
1084|114|S|effects. You may report side effects to Health Canada at||
1084|115|S|1-866-234-2345.||
1084|116|B|||
1084|117|P|PRECAUTIONS:  Before using dalteparin, tell your doctor or||
1084|118|P|pharmacist if you are allergic to it; or to heparins or pork||
1084|119|P|products; or if you have any other allergies. This product may||
1084|120|P|contain inactive ingredients (such as benzyl alcohol), which can||
1084|121|P|cause allergic reactions or other problems. Talk to your||
1084|122|P|pharmacist for more details.||
1084|123|P|   Before using this medication, tell your doctor or pharmacist||
1084|124|P|your medical history, especially of: serious active bleeding,||
1084|125|P|artificial heart valves, bleeding or blood disorders (low||
1084|126|P|platelet counts), certain eye problems (hypertensive or diabetic||
1084|127|P|retinopathy), high blood pressure, infection of the heart, kidney||
1084|128|P|disease, liver disease, low platelet counts after previous||
1084|129|P|heparin treatment, certain stomach/intestinal problems (such as||
1084|130|P|active or recent ulcers), stroke, recent spinal procedures or||
1084|131|P|puncture, spine problems (such as spinal deformity), recent||
1084|132|P|eye/brain/spinal cord surgery.||
1084|133|P|   Limit alcohol while using this drug because it may increase||
1084|134|P|the risk of stomach bleeding.||
1084|135|P|   Before having surgery, tell your doctor or dentist about all||
1084|136|P|the products you use (including prescription drugs,||
1084|137|P|nonprescription drugs, and herbal products).||
1084|138|P|   To lower the chance of getting cut, bruised, or injured, use||
1084|139|P|caution with sharp objects like razors and nail cutters, and||
1084|140|P|avoid activities such as contact sports.||
1084|141|P|   Older adults may be more sensitive to the side effects of this||
1084|142|P|drug, especially bleeding.||
1084|143|P|   During pregnancy, this medication should be used only when||
1084|144|P|clearly needed. Discuss the risks and benefits with your doctor.||
1084|145|P|   This medication passes into breast milk. Consult your doctor||
1084|146|P|before breastfeeding.||
1084|147|B|||
1084|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1084|149|I|medications work or increase your risk for serious side effects.||
1084|150|I|This document does not contain all possible drug interactions.||
1084|151|I|Keep a list of all the products you use (including||
1084|152|I|prescription/nonprescription drugs and herbal products) and share||
1084|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
1084|154|I|the dosage of any medicines without your doctor's approval.||
1084|155|I|   A product that may interact with this drug is: mifepristone.||
1084|156|I|   This medication is sometimes used together with other drugs||
1084|157|I|that have "blood thinning" or anti-platelet effects such as||
1084|158|I|aspirin, clopidogrel, or warfarin. When these combinations are||
1084|159|I|prescribed by your doctor, you will require closer monitoring to||
1084|160|I|minimize your risk of bleeding. Keep all medical and lab||
1084|161|I|appointments.||
1084|162|I|   Check all prescription and nonprescription medicine labels||
1084|163|I|carefully since many medications contain pain relievers/fever||
1084|164|I|reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) which||
1084|165|I|can increase the risk of bleeding/anti-platelet effect when used||
1084|166|I|with dalteparin. However, if your doctor has told you to take||
1084|167|I|low-dose aspirin to prevent heart attack or stroke (usually||
1084|168|I|81-162 milligrams a day), you should keep taking the aspirin||
1084|169|I|unless your doctor tells you not to. Ask your doctor or||
1084|170|I|pharmacist for more details.||
1084|171|B|||
1084|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1084|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1084|174|O|poison control center right away. US residents can call||
1084|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1084|176|O|Symptoms of overdose may include: excessive bleeding and||
1084|177|O|bruising.||
1084|178|B|||
1084|179|N|NOTES:  Do not share this medication with others.||
1084|180|N|   Lab and/or medical tests (such as complete blood count,||
1084|181|N|anti-factor Xa blood levels) should be done while you are using||
1084|182|N|this medication. Keep all medical and lab appointments. Consult||
1084|183|N|your doctor for more details.||
1084|184|B|||
1084|185|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1084|186|D|If it is near the time of the next dose, skip the missed dose.||
1084|187|D|Use your next dose at the regular time. Do not double the dose to||
1084|188|D|catch up.||
1084|189|B|||
1084|190|R|STORAGE:  Store at room temperature. Keep all medications away||
1084|191|R|from children and pets.||
1084|192|R|   After you first use a multiple-dose vial, store it at room||
1084|193|R|temperature for up to 2 weeks. Discard it after 2 weeks.||
1084|194|R|   Do not flush medications down the toilet or pour them into a||
1084|195|R|drain unless instructed to do so. Properly discard this product||
1084|196|R|when it is expired or no longer needed. Consult your pharmacist||
1084|197|R|or local waste disposal company.||
1084|198|B|||
1084|199|M|MEDICAL ALERT:  Your condition can cause complications in a||
1084|200|M|medical emergency. For information about enrolling in MedicAlert,||
1084|201|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1084|202|B|||
1084|203|A|Information last revised December 2024.||
1084|204|A|Copyright(c) 2025 First Databank, Inc.||
1084|205|B|||
1085|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1085|002|Z|does NOT have all possible information about this product. This||
1085|003|Z|information does not assure that this product is safe, effective,||
1085|004|Z|or appropriate for you. This information is not individual||
1085|005|Z|medical advice and does not substitute for the advice of your||
1085|006|Z|health care professional. Always ask your health care||
1085|007|Z|professional for complete information about this product and your||
1085|008|Z|specific health needs.||
1085|009|B|||
1085|010|T|FOSAPREPITANT - INJECTION||
1085|011|F|(FOS-a-PRE-pi-tant)||
1085|012|B|||
1085|013|C|COMMON BRAND NAME(S): Emend, Focinvez||
1085|014|B|||
1085|015|U|USES:  Fosaprepitant is used with other medications to help||
1085|016|U|prevent nausea and vomiting caused by cancer drug treatment||
1085|017|U|(chemotherapy). Fosaprepitant works by blocking one of the body's||
1085|018|U|natural substances (substance P/neurokinin 1) that causes||
1085|019|U|vomiting.||
1085|020|U|   This medication will not treat nausea or vomiting that has||
1085|021|U|already started. Ask your doctor what you should do if you||
1085|022|U|already have nausea or vomiting.||
1085|023|B|||
1085|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1085|025|H|from your pharmacist before you start using fosaprepitant and||
1085|026|H|each time you get treatment. If you have any questions, ask your||
1085|027|H|doctor or pharmacist.||
1085|028|H|   This medication is given by injection into a vein by a health||
1085|029|H|care professional as directed by your doctor. The infusion of||
1085|030|H|this medication is usually finished about 30 minutes before the||
1085|031|H|start of chemotherapy. Your doctor may also direct you to take a||
1085|032|H|form of this medication given by mouth (aprepitant) for the next||
1085|033|H|2 days. Follow your doctor's instructions carefully. Children's||
1085|034|H|dosage is based on weight and age. If you have any questions, ask||
1085|035|H|your doctor or pharmacist.||
1085|036|H|   Severe allergic reactions may happen during the infusion of||
1085|037|H|this drug and for a short time afterward. Get medical help right||
1085|038|H|away if you have any symptoms of allergic reactions such as||
1085|039|H|flushing, redness, or trouble breathing. Your doctor may stop||
1085|040|H|your treatment.||
1085|041|H|   Tell your doctor if you vomit or feel nauseated.||
1085|042|B|||
1085|043|S|SIDE EFFECTS:  See also How to Use section.||
1085|044|S|   Tiredness or hiccups may occur. If either of these effects||
1085|045|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
1085|046|S|   Remember that this medication has been prescribed because your||
1085|047|S|doctor has judged that the benefit to you is greater than the||
1085|048|S|risk of side effects. Many people using this medication do not||
1085|049|S|have serious side effects.||
1085|050|S|   Tell your doctor right away if you have any serious side||
1085|051|S|effects, including: redness/sores/pain/swelling at or near the||
1085|052|S|injection site.||
1085|053|S|   A very serious allergic reaction to this drug is rare.||
1085|054|S|However, get medical help right away if you notice any symptoms||
1085|055|S|of a serious allergic reaction, including: rash, itching/swelling||
1085|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1085|057|S|breathing.||
1085|058|S|   This is not a complete list of possible side effects. If you||
1085|059|S|notice other effects not listed above, contact your doctor or||
1085|060|S|pharmacist.||
1085|061|S|   In the US -||
1085|062|S|   Call your doctor for medical advice about side effects. You||
1085|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1085|064|S|www.fda.gov/medwatch.||
1085|065|S|   In Canada - Call your doctor for medical advice about side||
1085|066|S|effects. You may report side effects to Health Canada at||
1085|067|S|1-866-234-2345.||
1085|068|B|||
1085|069|P|PRECAUTIONS:  Before using fosaprepitant, tell your doctor or||
1085|070|P|pharmacist if you are allergic to it; or to aprepitant; or if you||
1085|071|P|have any other allergies. This product may contain inactive||
1085|072|P|ingredients, which can cause allergic reactions or other||
1085|073|P|problems. Talk to your pharmacist for more details.||
1085|074|P|   Before using this medication, tell your doctor or pharmacist||
1085|075|P|your medical history, especially of: liver disease.||
1085|076|P|   Before having surgery, tell your doctor or dentist about all||
1085|077|P|the products you use (including prescription drugs,||
1085|078|P|nonprescription drugs, and herbal products).||
1085|079|P|   During pregnancy, this medication should be used only when||
1085|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
1085|081|P|   It is unknown if this drug passes into breast milk. Consult||
1085|082|P|your doctor before breastfeeding.||
1085|083|B|||
1085|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1085|085|I|medications work or increase your risk for serious side effects.||
1085|086|I|This document does not contain all possible drug interactions.||
1085|087|I|Keep a list of all the products you use (including||
1085|088|I|prescription/nonprescription drugs and herbal products) and share||
1085|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
1085|090|I|the dosage of any medicines without your doctor's approval.||
1085|091|I|   Other medications can affect the removal of fosaprepitant from||
1085|092|I|your body, which may affect how fosaprepitant works. Examples||
1085|093|I|include azole antifungals (such as itraconazole, ketoconazole),||
1085|094|I|diltiazem, macrolide antibiotics (such as clarithromycin,||
1085|095|I|erythromycin), nefazodone, HIV protease inhibitors (such as||
1085|096|I|nelfinavir), rifamycins (such as rifampin, rifabutin), ritonavir,||
1085|097|I|St. John's wort, certain anti-seizure medicines (such as||
1085|098|I|carbamazepine, phenytoin), among others.||
1085|099|I|   Fosaprepitant can both speed up or slow down the removal of||
1085|100|I|other medications from your body, which may affect how they work.||
1085|101|I|Examples of affected drugs include flibanserin, lomitapide,||
1085|102|I|pimozide, among others.||
1085|103|I|   If you take warfarin, this drug may affect how well warfarin||
1085|104|I|works in your body. Your doctor should test your blood during the||
1085|105|I|2 weeks after your fosaprepitant treatment to measure how well||
1085|106|I|warfarin is working.||
1085|107|I|   This medication may decrease the effectiveness of hormonal||
1085|108|I|birth control such as pills, patch, or ring. This could cause||
1085|109|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1085|110|I|use reliable backup birth control methods while using this||
1085|111|I|medication and for 1 month after the last dose. Also tell your||
1085|112|I|doctor if you have any new spotting or breakthrough bleeding,||
1085|113|I|because these may be signs that your birth control is not working||
1085|114|I|well.||
1085|115|I|   Fosaprepitant is very similar to aprepitant. Do not use||
1085|116|I|aprepitant while using fosaprepitant.||
1085|117|B|||
1085|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1085|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1085|120|O|poison control center right away. US residents can call||
1085|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1085|122|B|||
1085|123|N|NOTES:  Not applicable.||
1085|124|B|||
1085|125|D|MISSED DOSE:  It is important to get each dose of this medication||
1085|126|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1085|127|D|right away for a new dosing schedule. Do not double the dose to||
1085|128|D|catch up.||
1085|129|B|||
1085|130|R|STORAGE:  Not applicable. This medication is given in a clinic||
1085|131|R|and will not be stored at home.||
1085|132|B|||
1085|133|A|Information last revised May 2024.||
1085|134|A|Copyright(c) 2025 First Databank, Inc.||
1085|135|B|||
1086|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1086|002|Z|does NOT have all possible information about this product. This||
1086|003|Z|information does not assure that this product is safe, effective,||
1086|004|Z|or appropriate for you. This information is not individual||
1086|005|Z|medical advice and does not substitute for the advice of your||
1086|006|Z|health care professional. Always ask your health care||
1086|007|Z|professional for complete information about this product and your||
1086|008|Z|specific health needs.||
1086|009|B|||
1086|010|T|DEXTROMETHORPHAN/DECONGESTANT/ACETAMINOPHEN/ANTIHISTAMINE - ORAL||
1086|011|B|||
1086|012|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
1086|013|W|too much acetaminophen may cause serious (possibly fatal) liver||
1086|014|W|disease. Adults should not take more than 4000 milligrams (4||
1086|015|W|grams) of acetaminophen a day. People with liver problems and||
1086|016|W|children should take less acetaminophen. Ask your doctor or||
1086|017|W|pharmacist how much acetaminophen is safe to take.||
1086|018|W|   Do not use with any other drug containing acetaminophen||
1086|019|W|without asking your doctor or pharmacist first. Acetaminophen is||
1086|020|W|in many nonprescription and prescription medications (such as||
1086|021|W|pain/fever drugs or cough-and-cold products). Check the labels on||
1086|022|W|all your medicines to see if they contain acetaminophen, and ask||
1086|023|W|your pharmacist if you are unsure.||
1086|024|W|   Get medical help right away if you take too much acetaminophen||
1086|025|W|(overdose), even if you feel well. Overdose symptoms may include||
1086|026|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
1086|027|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
1086|028|W|   Daily alcohol use, especially when combined with||
1086|029|W|acetaminophen, may damage your liver. Avoid alcohol.||
1086|030|B|||
1086|031|U|USES:  This combination medication is used to temporarily treat||
1086|032|U|symptoms caused by the common cold, flu, allergies, or other||
1086|033|U|breathing illnesses (such as sinusitis, bronchitis).||
1086|034|U|Dextromethorphan is a cough suppressant that affects a certain||
1086|035|U|part of the brain, reducing the urge to cough. Decongestants help||
1086|036|U|relieve stuffy nose and ear congestion symptoms. Acetaminophen||
1086|037|U|(APAP) is a non-aspirin pain reliever and fever reducer.||
1086|038|U|Antihistamines help relieve watery eyes, itchy eyes/nose/throat,||
1086|039|U|runny nose, and sneezing.||
1086|040|U|   This medication is not usually used for ongoing coughs from||
1086|041|U|smoking, asthma, or other long-term breathing problems (such as||
1086|042|U|emphysema), or for coughs with a lot of mucus, unless directed by||
1086|043|U|your doctor.||
1086|044|U|   Cough-and-cold products have not been shown to be safe or||
1086|045|U|effective in children younger than 6 years. Do not use this||
1086|046|U|product to treat cold symptoms in children younger than 6 years||
1086|047|U|unless specifically directed by the doctor. Some products (such||
1086|048|U|as long-acting tablets/capsules) are not recommended for use in||
1086|049|U|children younger than 12 years. Ask your doctor or pharmacist for||
1086|050|U|more details about using your product safely.||
1086|051|U|   These products do not cure or shorten the length of the common||
1086|052|U|cold and may cause serious side effects. To decrease the risk for||
1086|053|U|serious side effects, carefully follow all dosage directions. Do||
1086|054|U|not use this product to make a child sleepy. Do not give other||
1086|055|U|cough-and-cold medication that might contain the same or similar||
1086|056|U|ingredients (see also Drug Interactions section). Ask the doctor||
1086|057|U|or pharmacist about other ways to relieve cough and cold symptoms||
1086|058|U|(such as drinking enough fluids, using a humidifier or saline||
1086|059|U|nose drops/spray).||
1086|060|B|||
1086|061|H|HOW TO USE:  See also Warning section.||
1086|062|H|   If you are taking the over-the-counter product, read and||
1086|063|H|follow all directions on the package label. If your doctor has||
1086|064|H|prescribed this medication for you, take as directed by your||
1086|065|H|doctor. If you have any questions, consult your doctor or||
1086|066|H|pharmacist.||
1086|067|H|   Take this medication by mouth with or without food or as||
1086|068|H|directed by your doctor. If stomach upset occurs, it may help to||
1086|069|H|take this medication with food or milk. Drink plenty of fluids||
1086|070|H|when you use this medication unless otherwise directed by your||
1086|071|H|doctor. The fluid will help loosen the mucus in your lungs.||
1086|072|H|   If you are using the liquid form of this medication, carefully||
1086|073|H|measure the dose using a special measuring device/spoon. Do not||
1086|074|H|use a household spoon because you may not get the correct dose.||
1086|075|H|If your liquid form is a suspension, shake the bottle well before||
1086|076|H|each dose.||
1086|077|H|   If you are taking extended-release capsules, swallow them||
1086|078|H|whole. Do not crush or chew extended-release capsules or tablets.||
1086|079|H|Doing so can release all of the drug at once, increasing the risk||
1086|080|H|of side effects. Also, do not split extended-release tablets||
1086|081|H|unless they have a score line and your doctor or pharmacist tells||
1086|082|H|you to do so. Swallow the whole or split tablet without crushing||
1086|083|H|or chewing.||
1086|084|H|   If you are taking the chewable form of this medication, chew||
1086|085|H|it thoroughly before swallowing.||
1086|086|H|   The dosage is based on your age, medical condition, and||
1086|087|H|response to treatment. Do not increase your dose, take it more||
1086|088|H|often, or use it for a longer time than directed. Improper use of||
1086|089|H|this medication (abuse) may result in serious harm (including||
1086|090|H|brain damage, seizure, death).||
1086|091|H|   Tell your doctor if your condition lasts for more than 1 week,||
1086|092|H|if it gets worse, or if it occurs with a headache that doesn't go||
1086|093|H|away, rash, or fever lasting more than 3 days. These may be||
1086|094|H|symptoms of a serious medical problem and should be checked by a||
1086|095|H|doctor.||
1086|096|B|||
1086|097|S|SIDE EFFECTS:  See also Warning section.||
1086|098|S|   Drowsiness, dizziness, blurred vision, upset stomach, nausea,||
1086|099|S|nervousness, constipation, or dry mouth/nose/throat may occur. If||
1086|100|S|any of these effects last or get worse, tell your doctor or||
1086|101|S|pharmacist promptly.||
1086|102|S|   If your doctor has prescribed this medication, remember that||
1086|103|S|your doctor has judged that the benefit to you is greater than||
1086|104|S|the risk of side effects. Many people using this medication do||
1086|105|S|not have serious side effects.||
1086|106|S|   This medication may raise your blood pressure. Check your||
1086|107|S|blood pressure regularly and tell your doctor if the results are||
1086|108|S|high.||
1086|109|S|   Tell your doctor right away if you have any serious side||
1086|110|S|effects, including: mental/mood changes (such as confusion,||
1086|111|S|hallucinations), shaking, trouble urinating, fast/slow/irregular||
1086|112|S|heartbeat, seizure.||
1086|113|S|   A very serious allergic reaction to this drug is rare.||
1086|114|S|However, get medical help right away if you notice any symptoms||
1086|115|S|of a serious allergic reaction, including: rash, itching/swelling||
1086|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1086|117|S|breathing.||
1086|118|S|   This is not a complete list of possible side effects. If you||
1086|119|S|notice other effects not listed above, contact your doctor or||
1086|120|S|pharmacist.||
1086|121|S|   In the US -||
1086|122|S|   Call your doctor for medical advice about side effects. You||
1086|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1086|124|S|www.fda.gov/medwatch.||
1086|125|S|   In Canada - Call your doctor for medical advice about side||
1086|126|S|effects. You may report side effects to Health Canada at||
1086|127|S|1-866-234-2345.||
1086|128|B|||
1086|129|P|PRECAUTIONS:  See also Warning section.||
1086|130|P|   Before taking this product, tell your doctor or pharmacist if||
1086|131|P|you are allergic to any of its ingredients; or if you have any||
1086|132|P|other allergies. This product may contain inactive ingredients,||
1086|133|P|which can cause allergic reactions or other problems. Talk to||
1086|134|P|your pharmacist for more details.||
1086|135|P|   If you have any of the following health problems, consult your||
1086|136|P|doctor or pharmacist before using this medication: breathing||
1086|137|P|problems (such as asthma, emphysema), diabetes, glaucoma, heart||
1086|138|P|problems, high blood pressure, kidney problems, liver disease,||
1086|139|P|seizures, stomach/intestinal problems (such as blockage,||
1086|140|P|constipation, ulcers), overactive thyroid (hyperthyroidism),||
1086|141|P|urination problems (such as trouble urinating due to enlarged||
1086|142|P|prostate, urinary retention).||
1086|143|P|   This drug may make you dizzy or drowsy or blur your vision.||
1086|144|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1086|145|P|drowsy. Do not drive, use machinery, or do anything that needs||
1086|146|P|alertness or clear vision until you can do it safely. Avoid||
1086|147|P|alcoholic beverages. Talk to your doctor if you are using||
1086|148|P|marijuana (cannabis).||
1086|149|P|   Some brands of this product may contain sugar, alcohol, or||
1086|150|P|aspartame. Caution is advised if you have diabetes, alcohol||
1086|151|P|dependence, liver disease, phenylketonuria (PKU), or any other||
1086|152|P|condition that requires you to limit/avoid these substances in||
1086|153|P|your diet. Ask your doctor or pharmacist about using this product||
1086|154|P|safely.||
1086|155|P|   Before having surgery, tell your doctor or dentist about all||
1086|156|P|the products you use (including prescription drugs,||
1086|157|P|nonprescription drugs, and herbal products).||
1086|158|P|   Older adults may be more sensitive to the side effects of this||
1086|159|P|drug, especially dizziness, drowsiness, mental/mood changes,||
1086|160|P|constipation, trouble urinating, fast heartbeat, and blood||
1086|161|P|pressure changes. Dizziness, drowsiness and confusion can||
1086|162|P|increase the risk of falling.||
1086|163|P|   During pregnancy, this medication should be used only when||
1086|164|P|clearly needed. Discuss the risks and benefits with your doctor.||
1086|165|P|   This medication may pass into breast milk and may have||
1086|166|P|undesirable effects on a nursing infant. Consult your doctor||
1086|167|P|before breastfeeding.||
1086|168|B|||
1086|169|I|DRUG INTERACTIONS:  See also Warning section.||
1086|170|I|   Drug interactions may change how your medications work or||
1086|171|I|increase your risk for serious side effects. This document does||
1086|172|I|not contain all possible drug interactions. Keep a list of all||
1086|173|I|the products you use (including prescription/nonprescription||
1086|174|I|drugs and herbal products) and share it with your doctor and||
1086|175|I|pharmacist. Do not start, stop, or change the dosage of any||
1086|176|I|medicines without your doctor's approval.||
1086|177|I|   Taking certain MAO inhibitors with this medication may cause a||
1086|178|I|serious (possibly fatal) drug interaction. Avoid taking||
1086|179|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
1086|180|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
1086|181|I|tranylcypromine during treatment with this medication. Most MAO||
1086|182|I|inhibitors should also not be taken for two weeks before||
1086|183|I|treatment with this medication. Ask your doctor when to start or||
1086|184|I|stop taking this medication.||
1086|185|I|   Some products that may interact with this drug are:||
1086|186|I|antihistamines applied to the skin (such as diphenhydramine||
1086|187|I|cream, ointment, spray), ketoconazole, levoketoconazole,||
1086|188|I|rolapitant.||
1086|189|I|   Tell your doctor or pharmacist if you are taking other||
1086|190|I|products that cause drowsiness such as opioid pain or cough||
1086|191|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1086|192|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1086|193|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1086|194|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1086|195|I|diphenhydramine).||
1086|196|I|   The ingredients in this product are available in many||
1086|197|I|prescription and nonprescription products. Check the labels on||
1086|198|I|all your medicines (such as pain/fever drugs, diet aids, or||
1086|199|I|cough-and-cold/allergy products) because they may contain the||
1086|200|I|same or similar ingredients. Using these drugs along with this||
1086|201|I|product could increase side effects (such as fast heartbeat,||
1086|202|I|increased blood pressure, or drowsiness). Ask your pharmacist||
1086|203|I|about using those products safely.||
1086|204|I|   This medication may interfere with certain lab tests (such as||
1086|205|I|urine drug screening tests, urine 5-HIAA, allergy skin test),||
1086|206|I|possibly causing false test results. Make sure lab personnel and||
1086|207|I|all your doctors know you use this drug.||
1086|208|B|||
1086|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1086|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1086|211|O|poison control center right away. US residents can call||
1086|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1086|213|O|Symptoms of overdose may include: nausea, vomiting, loss of||
1086|214|O|appetite, sweating, stomach/abdominal pain, extreme tiredness,||
1086|215|O|agitation, confusion, flushing, hallucinations, yellowing||
1086|216|O|eyes/skin, dark urine, seizures. In children, excitement may||
1086|217|O|occur first, and may be followed by: loss of coordination,||
1086|218|O|drowsiness, loss of consciousness, seizures.||
1086|219|B|||
1086|220|N|NOTES:  Keep all medical and lab appointments.||
1086|221|B|||
1086|222|D|MISSED DOSE:  If you are taking this product on a regular||
1086|223|D|schedule and miss a dose, take it as soon as you remember. If it||
1086|224|D|is near the time of the next dose, skip the missed dose. Take||
1086|225|D|your next dose at the regular time. Do not double the dose to||
1086|226|D|catch up.||
1086|227|B|||
1086|228|R|STORAGE:  Store at room temperature away from light and moisture.||
1086|229|R|Do not store in the bathroom. Do not freeze liquid forms of this||
1086|230|R|medication. Keep all medications away from children and pets.||
1086|231|R|   Do not flush medications down the toilet or pour them into a||
1086|232|R|drain unless instructed to do so. Properly discard this product||
1086|233|R|when it is expired or no longer needed. Consult your pharmacist||
1086|234|R|or local waste disposal company.||
1086|235|B|||
1086|236|A|Information last revised July 2025.||
1086|237|A|Copyright(c) 2025 First Databank, Inc.||
1086|238|B|||
1087|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1087|002|Z|does NOT have all possible information about this product. This||
1087|003|Z|information does not assure that this product is safe, effective,||
1087|004|Z|or appropriate for you. This information is not individual||
1087|005|Z|medical advice and does not substitute for the advice of your||
1087|006|Z|health care professional. Always ask your health care||
1087|007|Z|professional for complete information about this product and your||
1087|008|Z|specific health needs.||
1087|009|B|||
1087|010|T|ORPHENADRINE - ORAL||
1087|011|F|(or-FEN-uh-dreen)||
1087|012|B|||
1087|013|C|COMMON BRAND NAME(S): Norflex||
1087|014|B|||
1087|015|U|USES:  Orphenadrine is used to treat muscle spasms/pain. It is||
1087|016|U|usually used along with rest, physical therapy, and other||
1087|017|U|treatment.||
1087|018|B|||
1087|019|H|HOW TO USE:  Take this medication by mouth with or without food||
1087|020|H|as directed by your doctor. Do not increase your dose or use this||
1087|021|H|drug more often or for longer than prescribed. Your condition||
1087|022|H|will not improve any faster, and your risk of side effects will||
1087|023|H|increase.||
1087|024|H|   If you are using the extended-release tablets, swallow the||
1087|025|H|tablets whole. Do not crush or chew the tablets. Doing so can||
1087|026|H|release all of the drug at once, increasing the risk of side||
1087|027|H|effects.||
1087|028|H|   Tell your doctor if your condition does not get better or if||
1087|029|H|it gets worse.||
1087|030|B|||
1087|031|S|SIDE EFFECTS:  Dry mouth, dizziness, drowsiness, lightheadedness,||
1087|032|S|blurred vision, nausea, vomiting, and constipation may occur. If||
1087|033|S|any of these effects last or get worse, tell your doctor or||
1087|034|S|pharmacist promptly.||
1087|035|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
1087|036|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1087|037|S|substitute.||
1087|038|S|   Remember that this medication has been prescribed because your||
1087|039|S|doctor has judged that the benefit to you is greater than the||
1087|040|S|risk of side effects. Many people using this medication do not||
1087|041|S|have serious side effects.||
1087|042|S|   Tell your doctor right away if you have any serious side||
1087|043|S|effects, including: mental/mood changes (such as confusion,||
1087|044|S|anxiety, hallucinations), shaking (tremor), fast/pounding||
1087|045|S|heartbeat, fainting, difficulty urinating, eye pain.||
1087|046|S|   A very serious allergic reaction to this drug is rare.||
1087|047|S|However, get medical help right away if you notice any symptoms||
1087|048|S|of a serious allergic reaction, including: rash, itching/swelling||
1087|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1087|050|S|breathing.||
1087|051|S|   This is not a complete list of possible side effects. If you||
1087|052|S|notice other effects not listed above, contact your doctor or||
1087|053|S|pharmacist.||
1087|054|S|   In the US -||
1087|055|S|   Call your doctor for medical advice about side effects. You||
1087|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1087|057|S|www.fda.gov/medwatch.||
1087|058|S|   In Canada - Call your doctor for medical advice about side||
1087|059|S|effects. You may report side effects to Health Canada at||
1087|060|S|1-866-234-2345.||
1087|061|B|||
1087|062|P|PRECAUTIONS:  Before taking orphenadrine, tell your doctor or||
1087|063|P|pharmacist if you are allergic to it; or if you have any other||
1087|064|P|allergies. This product may contain inactive ingredients, which||
1087|065|P|can cause allergic reactions or other problems. Talk to your||
1087|066|P|pharmacist for more details.||
1087|067|P|   Before using this medication, tell your doctor or pharmacist||
1087|068|P|your medical history, especially of: high pressure in the eye||
1087|069|P|(glaucoma), stomach/intestinal/esophagus problems (such as||
1087|070|P|ulcers, blockage), difficulty urinating (such as due to enlarged||
1087|071|P|prostate), a certain type of muscle/nerve disease (myasthenia||
1087|072|P|gravis), heart problems (such as fast/irregular heartbeat, heart||
1087|073|P|failure).||
1087|074|P|   This drug may make you dizzy or drowsy or blur your vision.||
1087|075|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1087|076|P|drowsy. Do not drive, use machinery, or do anything that needs||
1087|077|P|alertness or clear vision until you can do it safely. Limit||
1087|078|P|alcoholic beverages. Talk to your doctor if you are using||
1087|079|P|marijuana (cannabis).||
1087|080|P|   Before having surgery, tell your doctor or dentist about all||
1087|081|P|the products you use (including prescription drugs,||
1087|082|P|nonprescription drugs, and herbal products).||
1087|083|P|   Older adults may be more sensitive to the side effects of this||
1087|084|P|drug, especially confusion, drowsiness, constipation, or trouble||
1087|085|P|urinating. Confusion and drowsiness can increase the risk of||
1087|086|P|falling.||
1087|087|P|   During pregnancy, this medication should be used only when||
1087|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
1087|089|P|   It is unknown if this drug passes into breast milk. Consult||
1087|090|P|your doctor before breastfeeding.||
1087|091|B|||
1087|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1087|093|I|medications work or increase your risk for serious side effects.||
1087|094|I|This document does not contain all possible drug interactions.||
1087|095|I|Keep a list of all the products you use (including||
1087|096|I|prescription/nonprescription drugs and herbal products) and share||
1087|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
1087|098|I|the dosage of any medicines without your doctor's approval.||
1087|099|I|   Tell your doctor or pharmacist if you are taking other||
1087|100|I|products that cause drowsiness such as opioid pain or cough||
1087|101|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1087|102|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1087|103|I|lorazepam, zolpidem), other muscle relaxants (such as||
1087|104|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1087|105|I|cetirizine, diphenhydramine).||
1087|106|I|   Check the labels on all your medicines (such as allergy or||
1087|107|I|cough-and-cold products) because they may contain ingredients||
1087|108|I|that cause drowsiness. Ask your pharmacist about using those||
1087|109|I|products safely.||
1087|110|B|||
1087|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1087|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1087|113|O|poison control center right away. US residents can call||
1087|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1087|115|O|Symptoms of overdose may include: unusual excitement,||
1087|116|O|fast/irregular heartbeat, seizures.||
1087|117|B|||
1087|118|N|NOTES:  Do not share this medication with others.||
1087|119|N|   This medication has been prescribed for your current condition||
1087|120|N|only. Do not use it later for another condition unless your||
1087|121|N|doctor directs you to do so. A different medication may be||
1087|122|N|necessary in that case.||
1087|123|N|   If you are taking this medication for a long time, lab and/or||
1087|124|N|medical tests may be done while you are taking this medication.||
1087|125|N|Keep all medical and lab appointments. Consult your doctor for||
1087|126|N|more details.||
1087|127|B|||
1087|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1087|129|D|remember. If it is near the time of the next dose, skip the||
1087|130|D|missed dose. Take your next dose at the regular time. Do not||
1087|131|D|double the dose to catch up.||
1087|132|B|||
1087|133|R|STORAGE:  Store at room temperature away from light and moisture.||
1087|134|R|Do not store in the bathroom. Keep all medications away from||
1087|135|R|children and pets.||
1087|136|R|   Do not flush medications down the toilet or pour them into a||
1087|137|R|drain unless instructed to do so. Properly discard this product||
1087|138|R|when it is expired or no longer needed. Consult your pharmacist||
1087|139|R|or local waste disposal company.||
1087|140|B|||
1087|141|A|Information last revised October 2024.||
1087|142|A|Copyright(c) 2025 First Databank, Inc.||
1087|143|B|||
1088|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1088|002|Z|does NOT have all possible information about this product. This||
1088|003|Z|information does not assure that this product is safe, effective,||
1088|004|Z|or appropriate for you. This information is not individual||
1088|005|Z|medical advice and does not substitute for the advice of your||
1088|006|Z|health care professional. Always ask your health care||
1088|007|Z|professional for complete information about this product and your||
1088|008|Z|specific health needs.||
1088|009|B|||
1088|010|T|FRAMYCETIN/GRAMICIDIN/DEXAMETHASONE SOLUTION - OPHTHALMIC/OTIC||
1088|011|F|(fram-eye-SEAT-in/gram-ih-SYE-din/dex-uh-METH-uh-sown)||
1088|012|B|||
1088|013|U|USES:  This medication is used to prevent and treat bacterial||
1088|014|U|infections of the eye and outer ear. It is also used to treat||
1088|015|U|redness/swelling/itching (inflammation) of the eye/ear from other||
1088|016|U|causes (such as allergy, rosacea, seborrhea, eczema). This||
1088|017|U|product contains framycetin (also known as neomycin B) and||
1088|018|U|gramicidin, antibiotics that work by stopping the growth of||
1088|019|U|bacteria. It also contains dexamethasone, an anti-inflammatory||
1088|020|U|corticosteroid that works by reducing redness, swelling, and||
1088|021|U|itching.||
1088|022|U|   This medication treats/prevents only bacterial infections. It||
1088|023|U|will not work for other types of ear/eye infections and may||
1088|024|U|worsen them (such as infections caused by viruses, fungi,||
1088|025|U|mycobacteria). Using any antibiotic when it is not needed can||
1088|026|U|cause it to not work for future infections.||
1088|027|B|||
1088|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1088|029|H|from your pharmacist before you start using this product and each||
1088|030|H|time you get a refill. If you have any questions, ask your doctor||
1088|031|H|or pharmacist.||
1088|032|H|   This medication is for use in the eye or ear only. Do not take||
1088|033|H|by mouth.||
1088|034|H|   Wash your hands first before using this product. To avoid||
1088|035|H|contamination, do not touch the dropper tip or let it touch your||
1088|036|H|ear/eye or any other surface. Do not use the same bottle/dropper||
1088|037|H|in both the eye and the ear.||
1088|038|H|   EYE: Apply the medication to the affected eye(s) as directed||
1088|039|H|by your doctor, usually 3 to 4 times a day. Your doctor may||
1088|040|H|instruct you to use it more often for the first 2 to 3 days||
1088|041|H|(every 1 to 2 hours). Your dosage is based on your medical||
1088|042|H|condition and response to treatment. Do not use this medication||
1088|043|H|more often than prescribed or for longer than 10 days unless||
1088|044|H|directed by your doctor. Follow your doctor's instructions||
1088|045|H|carefully.||
1088|046|H|   Tilt your head back, look upward, and pull down the lower||
1088|047|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1088|048|H|and place 1 drop into the pouch. Look downward and gently close||
1088|049|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
1088|050|H|your eye (near the nose) and apply gentle pressure. This will||
1088|051|H|prevent the medication from draining out. Try not to blink and do||
1088|052|H|not rub your eye. Repeat these steps if your dose is for more||
1088|053|H|than 1 drop and for your other eye if so directed. Repeat as||
1088|054|H|often as directed by your doctor.||
1088|055|H|   If you are using another kind of eye medication (such as drops||
1088|056|H|or ointments), wait at least 5 minutes before applying other||
1088|057|H|medications. Use eye drops before eye ointments to allow the eye||
1088|058|H|drops to enter the eye.||
1088|059|H|   Do not rinse the dropper. Replace the dropper cap after each||
1088|060|H|use.||
1088|061|H|   Do not wear contact lenses while you are using this medicine.||
1088|062|H|Sterilize contact lenses according to manufacturer's directions,||
1088|063|H|and check with your doctor before you begin using them again.||
1088|064|H|   Wait several minutes for your vision to clear before driving||
1088|065|H|or operating machinery.||
1088|066|H|   EAR: Use this medication as directed by your doctor, usually 3||
1088|067|H|to 4 times daily. First, clean and dry the outer ear. To make||
1088|068|H|sure that the right amount of medication is given, and to avoid||
1088|069|H|touching the ear with the dropper, have another person insert the||
1088|070|H|drops if possible. To make it more comfortable to use, you may||
1088|071|H|hold the container in your hand for a few minutes to warm the||
1088|072|H|solution.||
1088|073|H|   To apply ear drops, wash your hands first. To avoid||
1088|074|H|contamination, do not touch the dropper tip or let it touch your||
1088|075|H|ear or any other surface. Lie on your side or tilt the affected||
1088|076|H|ear upward. Hold the dropper directly over the ear, and place the||
1088|077|H|prescribed number of drops into the ear canal. To help the drops||
1088|078|H|roll into the ear of an adult, hold the earlobe up and back. In||
1088|079|H|children, hold the earlobe down and back. Keep the head tilted||
1088|080|H|for about 5 minutes or insert a soft cotton plug if so directed.||
1088|081|H|Repeat for the other ear if so directed.||
1088|082|H|   Your doctor may direct you to give this medication in another||
1088|083|H|way by placing a cotton wick in the ear canal and moistening it||
1088|084|H|with the prescribed number of drops. The wick should be replaced||
1088|085|H|at least once a day.||
1088|086|H|   Do not rinse the dropper. Replace the cap after each use.||
1088|087|H|   Your dosage is based on your medical condition and response to||
1088|088|H|treatment. Do not use this medication more often than prescribed||
1088|089|H|or for longer than 5 to 7 days unless directed by your doctor.||
1088|090|H|   For the best effect, use this medication at evenly spaced||
1088|091|H|times. To help you remember, use it at the same times each day.||
1088|092|H|Continue to use this medication until the full prescribed amount||
1088|093|H|is finished, even if symptoms disappear after a few days.||
1088|094|H|Stopping the medication too early may result in a return of the||
1088|095|H|infection. If treatment is for allergies/swelling, then stopping||
1088|096|H|too soon may result in a return of symptoms.||
1088|097|H|   Tell your doctor if your condition lasts or gets worse.||
1088|098|B|||
1088|099|S|SIDE EFFECTS:  Stinging/burning (more common when used in the||
1088|100|S|eyes) for 1 to 2 minutes may occur when this medication is||
1088|101|S|applied. If any of these effects last or get worse, tell your||
1088|102|S|doctor or pharmacist promptly.||
1088|103|S|   Remember that this medication has been prescribed because your||
1088|104|S|doctor has judged that the benefit to you is greater than the||
1088|105|S|risk of side effects. Many people using this medication do not||
1088|106|S|have serious side effects.||
1088|107|S|   Use of this medication for prolonged/repeated periods may||
1088|108|S|result in a new fungal eye infection and may increase your risk||
1088|109|S|for other eye problems (such as glaucoma, cataracts, delayed||
1088|110|S|wound healing). Do not use this medication for longer than||
1088|111|S|prescribed.||
1088|112|S|   Tell your doctor right away if you have any serious side||
1088|113|S|effects, including: new or worsening eye/ear symptoms (such as||
1088|114|S|discharge, pus, swelling, redness), dizziness/feeling of||
1088|115|S|spinning, vision changes, eye pain, hearing loss, ringing in the||
1088|116|S|ears, unsteadiness/loss of balance.||
1088|117|S|   A very serious allergic reaction to this drug is rare.||
1088|118|S|However, get medical help right away if you notice any symptoms||
1088|119|S|of a serious allergic reaction, including: rash, itching/swelling||
1088|120|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1088|121|S|breathing.||
1088|122|S|   This is not a complete list of possible side effects. If you||
1088|123|S|notice other effects not listed above, contact your doctor or||
1088|124|S|pharmacist.||
1088|125|S|   In the US -||
1088|126|S|   Call your doctor for medical advice about side effects. You||
1088|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1088|128|S|www.fda.gov/medwatch.||
1088|129|S|   In Canada - Call your doctor for medical advice about side||
1088|130|S|effects. You may report side effects to Health Canada at||
1088|131|S|1-866-234-2345.||
1088|132|B|||
1088|133|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1088|134|P|pharmacist if you are allergic to framycetin, gramicidin, or||
1088|135|P|dexamethasone; or to other aminoglycoside antibiotics (such as||
1088|136|P|gentamicin, neomycin); or to other corticosteroids (such as||
1088|137|P|hydrocortisone, prednisone); or if you have any other allergies.||
1088|138|P|This product may contain inactive ingredients, which can cause||
1088|139|P|allergic reactions or other problems. Talk to your pharmacist for||
1088|140|P|more details.||
1088|141|P|   Before using this medication, tell your doctor or pharmacist||
1088|142|P|your medical history, especially of: glaucoma/increased pressure||
1088|143|P|inside the eye (if you are using this drug as eye drops), ear or||
1088|144|P|eye infections due to fungus or certain viruses (herpes) or||
1088|145|P|bacteria (tuberculosis, chlamydia), punctured eardrum (if you are||
1088|146|P|using this drug as ear drops), recent ear/eye surgery or injury||
1088|147|P|(such as cataract, ear tubes), diabetes.||
1088|148|P|   If you are using this product in your eye(s), your vision may||
1088|149|P|become temporarily blurred. Do not drive, use machinery, or do||
1088|150|P|anything that needs clear vision until you can do it safely.||
1088|151|P|   During pregnancy, this medication should be used only when||
1088|152|P|clearly needed. Discuss the risks and benefits with your doctor.||
1088|153|P|   It is unknown if this drug passes into breast milk. Consult||
1088|154|P|your doctor before breastfeeding.||
1088|155|B|||
1088|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1088|157|I|medications work or increase your risk for serious side effects.||
1088|158|I|This document does not contain all possible drug interactions.||
1088|159|I|Keep a list of all the products you use (including||
1088|160|I|prescription/nonprescription drugs and herbal products) and share||
1088|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
1088|162|I|the dosage of any medicines without your doctor's approval.||
1088|163|B|||
1088|164|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1088|165|O|has overdosed and has serious symptoms such as passing out or||
1088|166|O|trouble breathing, call 911. Otherwise, call a poison control||
1088|167|O|center right away. US residents can call 1-800-222-1222. Canada||
1088|168|O|residents can call 1-844-764-7669.||
1088|169|B|||
1088|170|N|NOTES:  Do not share this medication with others.||
1088|171|N|   This medication has been prescribed for your current condition||
1088|172|N|only. Throw away the unused medication after treatment is||
1088|173|N|completed. Do not use it later for another infection unless your||
1088|174|N|doctor tells you to.||
1088|175|N|   If you use this medication for more than 5 to 10 days, lab||
1088|176|N|and/or medical tests (such as ear or eye exams) should be done||
1088|177|N|while you are using this medication. Keep all medical and lab||
1088|178|N|appointments. Consult your doctor for more details.||
1088|179|B|||
1088|180|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1088|181|D|If it is near the time of the next dose, skip the missed dose.||
1088|182|D|Use your next dose at the regular time. Do not double the dose to||
1088|183|D|catch up.||
1088|184|B|||
1088|185|R|STORAGE:  Store at room temperature. Once the bottle is opened,||
1088|186|R|this medication expires after 28 days. Keep all medications away||
1088|187|R|from children and pets.||
1088|188|R|   Do not flush medications down the toilet or pour them into a||
1088|189|R|drain unless instructed to do so. Properly discard this product||
1088|190|R|when it is expired or no longer needed. Consult your pharmacist||
1088|191|R|or local waste disposal company.||
1088|192|B|||
1088|193|A|Information last revised September 2024.||
1088|194|A|Copyright(c) 2025 First Databank, Inc.||
1088|195|B|||
1089|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1089|002|Z|does NOT have all possible information about this product. This||
1089|003|Z|information does not assure that this product is safe, effective,||
1089|004|Z|or appropriate for you. This information is not individual||
1089|005|Z|medical advice and does not substitute for the advice of your||
1089|006|Z|health care professional. Always ask your health care||
1089|007|Z|professional for complete information about this product and your||
1089|008|Z|specific health needs.||
1089|009|B|||
1089|010|T|ESTRADIOL SPRAY - TRANSDERMAL||
1089|011|F|(ES-tra-DYE-ol)||
1089|012|B|||
1089|013|C|COMMON BRAND NAME(S): Evamist||
1089|014|B|||
1089|015|W|WARNING:  Estrogens, either used alone or with another hormone||
1089|016|W|(progestin), have rarely caused very serious side effects.||
1089|017|W|Discuss the risks and benefits of hormone treatment with your||
1089|018|W|doctor. Estrogens should not be used to prevent heart disease or||
1089|019|W|dementia.||
1089|020|W|   Estrogens can increase the risk of cancer of the uterus||
1089|021|W|(endometrial cancer). Taking a progestin as directed by your||
1089|022|W|doctor can help decrease this risk. Tell your doctor right away||
1089|023|W|if you have any unusual vaginal bleeding.||
1089|024|W|   In postmenopausal women, estrogens, taken with or without a||
1089|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
1089|026|W|stroke, dementia, and serious blood clots. When used along with a||
1089|027|W|progestin, estrogens also increase the risk of heart disease||
1089|028|W|(such as heart attacks).||
1089|029|W|   The risk for serious side effects may depend on the dose of||
1089|030|W|estrogen and the length of time it is used. This medication||
1089|031|W|should be used at the lowest effective dose and for the shortest||
1089|032|W|amount of time. Discuss the use of this medication with your||
1089|033|W|doctor regularly (for example, every 3 to 6 months) to see if you||
1089|034|W|still need to use it. If you will be taking this medication||
1089|035|W|long-term, you should have regular complete physical exams (for||
1089|036|W|example, once a year) as directed by your doctor. See also Notes||
1089|037|W|section.||
1089|038|W|   Do not let other people, especially children, come into||
1089|039|W|contact with this medication. They may be accidentally exposed to||
1089|040|W|this medication through contact with your forearm where you||
1089|041|W|sprayed it. If this occurs, a child may have unwanted side||
1089|042|W|effects. Tell the doctor right away if you notice unexpected||
1089|043|W|signs of puberty in a child such as an increase in breast or||
1089|044|W|nipple size. These side effects usually go away when exposure to||
1089|045|W|this medication stops. To decrease this risk, carefully follow||
1089|046|W|all directions for the proper use of this drug. See also the How||
1089|047|W|to Use section.||
1089|048|B|||
1089|049|U|USES:  This medication is a hormone (estrogen). It is absorbed||
1089|050|U|through the skin and enters into the bloodstream. It is used by||
1089|051|U|women to help reduce a certain symptom of menopause (hot||
1089|052|U|flashes). Symptoms of menopause are caused by the body making||
1089|053|U|less estrogen. If you are using estrogens to treat only vaginal||
1089|054|U|symptoms of menopause (such as vaginal dryness/burning/itching),||
1089|055|U|products applied directly inside the vagina should be considered||
1089|056|U|before medications that are taken by mouth, absorbed through the||
1089|057|U|skin, or injected.||
1089|058|B|||
1089|059|V|OTHER USES:  This section contains uses of this drug that are not||
1089|060|V|listed in the approved professional labeling for the drug but||
1089|061|V|that may be prescribed by your health care professional. Use this||
1089|062|V|drug for a condition that is listed in this section only if it||
1089|063|V|has been so prescribed by your health care professional.||
1089|064|V|   Certain estrogen products may also be prescribed for bone loss||
1089|065|V|(osteoporosis) in women after menopause. However, there are other||
1089|066|V|medications (such as raloxifene, bisphosphonates including||
1089|067|V|alendronate) that are also effective in preventing bone loss and||
1089|068|V|may be safer. These medications should be considered for use||
1089|069|V|before estrogen treatment.||
1089|070|B|||
1089|071|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1089|072|H|from your pharmacist before you start using this medication and||
1089|073|H|each time you get a refill. Learn how to use the spray correctly.||
1089|074|H|If you have any questions, ask your doctor or pharmacist.||
1089|075|H|   Follow the instructions for priming the spray if you are using||
1089|076|H|it for the first time.||
1089|077|H|   Keep the spray upright when using. Spray this medication on||
1089|078|H|clean, dry skin of the inside area of your forearm (between the||
1089|079|H|elbow and the wrist) as directed by your doctor, usually once||
1089|080|H|daily in the morning. If your dose is for more than 1 spray, do||
1089|081|H|not use more than 1 spray on the same area of the skin. The||
1089|082|H|application sites should be next to each other but not||
1089|083|H|overlapping. Avoid applying this medication to broken, irritated||
1089|084|H|skin. Do not apply this medication to other areas of the body,||
1089|085|H|including the breast, face, or in or around the vagina.||
1089|086|H|   The dosage is based on your medical condition and response to||
1089|087|H|treatment. Do not increase your dose or use this medication more||
1089|088|H|often than prescribed.||
1089|089|H|   Replace the cap on the spray after each use. After applying||
1089|090|H|this medication, wash your hands thoroughly with soap and water.||
1089|091|H|Wait at least 2 minutes for the application site to dry||
1089|092|H|completely before dressing. Do not rub the medication into the||
1089|093|H|skin. Cover the application site with clothing (such as a||
1089|094|H|long-sleeve shirt) to prevent others from touching the||
1089|095|H|application area and being exposed to the drug. If someone||
1089|096|H|accidentally touches the application site, have them wash the||
1089|097|H|area of contact on their body with soap and water as soon as||
1089|098|H|possible. Also, keep pets from coming into contact with the||
1089|099|H|application site.||
1089|100|H|   To get the best effect, wait at least 1 hour before washing||
1089|101|H|the application site to allow the drug to be absorbed through the||
1089|102|H|skin.||
1089|103|H|   Use this medication regularly to get the most benefit from it.||
1089|104|H|To help you remember, use it at the same time each day.||
1089|105|H|   Avoid getting this medication in the eyes. If this medication||
1089|106|H|gets in the eyes, rinse them right away with warm water. Tell||
1089|107|H|your doctor if you get any eye irritation.||
1089|108|H|   This medication is flammable until dry. Avoid smoking or being||
1089|109|H|near open flames while using the medication and until the||
1089|110|H|medication has dried.||
1089|111|H|   Keep track of the number of sprays you use. Discard the||
1089|112|H|container after you have used the labeled number of sprays on the||
1089|113|H|product package, even if there is medication left in the||
1089|114|H|container.||
1089|115|H|   Tell your doctor if your condition does not get better or if||
1089|116|H|it gets worse.||
1089|117|B|||
1089|118|S|SIDE EFFECTS:  See also Warning section.||
1089|119|S|   Nausea/vomiting, bloating, breast tenderness, headache, or||
1089|120|S|weight changes may occur. If any of these effects last or get||
1089|121|S|worse, tell your doctor or pharmacist promptly.||
1089|122|S|   Remember that this medication has been prescribed because your||
1089|123|S|doctor has judged that the benefit to you is greater than the||
1089|124|S|risk of side effects. Many people using this medication do not||
1089|125|S|have serious side effects.||
1089|126|S|   Tell your doctor right away if you have any serious side||
1089|127|S|effects, including: nausea/vomiting that doesn't stop,||
1089|128|S|mental/mood changes (such as depression, memory loss), breast||
1089|129|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
1089|130|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
1089|131|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
1089|132|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
1089|133|S|increased thirst/urination.||
1089|134|S|   This medication may rarely cause serious (sometimes fatal)||
1089|135|S|problems from blood clots (such as heart attack, stroke, blood||
1089|136|S|clots in the lungs or legs). Get medical help right away if you||
1089|137|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
1089|138|S|headaches, weakness on one side of the body, confusion, trouble||
1089|139|S|speaking, sudden vision changes, pain/swelling/warmth in the||
1089|140|S|groin/calf, shortness of breath/rapid breathing, sudden||
1089|141|S|dizziness/fainting.||
1089|142|S|   A very serious allergic reaction to this product is rare.||
1089|143|S|However, get medical help right away if you notice any symptoms||
1089|144|S|of a serious allergic reaction, including: rash, itching/swelling||
1089|145|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1089|146|S|breathing.||
1089|147|S|   This is not a complete list of possible side effects. If you||
1089|148|S|notice other effects not listed above, contact your doctor or||
1089|149|S|pharmacist.||
1089|150|S|   In the US -||
1089|151|S|   Call your doctor for medical advice about side effects. You||
1089|152|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1089|153|S|www.fda.gov/medwatch.||
1089|154|S|   In Canada - Call your doctor for medical advice about side||
1089|155|S|effects. You may report side effects to Health Canada at||
1089|156|S|1-866-234-2345.||
1089|157|B|||
1089|158|P|PRECAUTIONS:  Before using estradiol, tell your doctor or||
1089|159|P|pharmacist if you are allergic to it; or if you have any other||
1089|160|P|allergies. This product may contain inactive ingredients, which||
1089|161|P|can cause allergic reactions or other problems. Talk to your||
1089|162|P|pharmacist for more details.||
1089|163|P|   Before using this medication, tell your doctor or pharmacist||
1089|164|P|your medical history, especially of: vaginal bleeding of unknown||
1089|165|P|cause, certain cancers (such as breast cancer, cancer of the||
1089|166|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
1089|167|P|heart attack), liver disease, kidney disease, family medical||
1089|168|P|history (especially breast lumps, cancer, blood clots), family or||
1089|169|P|personal history of a certain swelling disorder (angioedema),||
1089|170|P|blood clotting disorders (such as protein C or protein S||
1089|171|P|deficiency), high blood pressure, diabetes, high||
1089|172|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
1089|173|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
1089|174|P|calcium in the blood), a certain hormone problem||
1089|175|P|(hypoparathyroidism), uterus problems (such as fibroids,||
1089|176|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
1089|177|P|headaches, mental/mood disorders (such as dementia, depression),||
1089|178|P|a certain blood disorder (porphyria).||
1089|179|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
1089|180|P|further increases your risk of stroke, blood clots, high blood||
1089|181|P|pressure, and heart attack, especially in women older than 35.||
1089|182|P|   Tell your doctor if you just had or will be having surgery, or||
1089|183|P|if you will be confined to a chair or bed for a long time (such||
1089|184|P|as a long plane flight). These conditions increase your risk of||
1089|185|P|getting blood clots, especially if you are using an estrogen||
1089|186|P|product. You may need to stop this medication for a time or take||
1089|187|P|special precautions.||
1089|188|P|   This drug may cause blotchy, dark areas on your face and skin||
1089|189|P|(melasma). Sunlight may worsen this effect. Limit your time in||
1089|190|P|the sun. Avoid tanning booths and sunlamps. Wear protective||
1089|191|P|clothing when outdoors. Ask your doctor or pharmacist about using||
1089|192|P|sunscreen with this medication. Sunscreen may affect the||
1089|193|P|absorption of this medication if applied on the area of the skin||
1089|194|P|where the medication was applied.||
1089|195|P|   If you are nearsighted or wear contact lenses, you may develop||
1089|196|P|vision problems or trouble wearing your contact lenses. Contact||
1089|197|P|your eye doctor if these problems occur.||
1089|198|P|   This product is not meant for children. See the Warning||
1089|199|P|section about the risks to children if they are accidentally||
1089|200|P|exposed to this medication.||
1089|201|P|   This medication should not be used during pregnancy. If you||
1089|202|P|become pregnant or think you may be pregnant, tell your doctor||
1089|203|P|right away.||
1089|204|P|   This medication passes into breast milk. Consult your doctor||
1089|205|P|before breastfeeding.||
1089|206|B|||
1089|207|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1089|208|I|medications work or increase your risk for serious side effects.||
1089|209|I|This document does not contain all possible drug interactions.||
1089|210|I|Keep a list of all the products you use (including||
1089|211|I|prescription/nonprescription drugs and herbal products) and share||
1089|212|I|it with your doctor and pharmacist. Do not start, stop, or change||
1089|213|I|the dosage of any medicines without your doctor's approval.||
1089|214|I|   Some products that may interact with this drug include:||
1089|215|I|aromatase inhibitors (such as anastrozole, exemestane,||
1089|216|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
1089|217|I|tamoxifen, toremifene, tranexamic acid.||
1089|218|I|   This medication may interfere with certain lab tests, possibly||
1089|219|I|causing false test results. Make sure lab personnel and all your||
1089|220|I|doctors know you use this drug.||
1089|221|B|||
1089|222|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1089|223|O|has overdosed and has serious symptoms such as passing out or||
1089|224|O|trouble breathing, call 911. Otherwise, call a poison control||
1089|225|O|center right away. US residents can call 1-800-222-1222. Canada||
1089|226|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1089|227|O|include: severe nausea/vomiting, unusual vaginal bleeding.||
1089|228|B|||
1089|229|N|NOTES:  Do not share this medication with others.||
1089|230|N|   Regular complete physical exams which include lab and/or||
1089|231|N|medical tests (such as blood pressure, breast exam/mammogram,||
1089|232|N|pelvic exam, Pap smear) should be done while you are using this||
1089|233|N|medication. Follow your doctor's instructions for examining your||
1089|234|N|breasts, and report any lumps right away. Keep all medical and||
1089|235|N|lab appointments. Consult your doctor for more details.||
1089|236|N|   Preventing or controlling high blood pressure, high||
1089|237|N|cholesterol, and diabetes can help to reduce your chances of||
1089|238|N|heart disease and stroke. Lifestyle changes that can help to||
1089|239|N|control or prevent these diseases include reducing stress, eating||
1089|240|N|a low fat/salt diet, losing weight if overweight, exercising||
1089|241|N|regularly, and stopping smoking. Keep your mind active with||
1089|242|N|mental exercises (such as reading, solving crossword puzzles) to||
1089|243|N|help prevent dementia. Talk to your doctor about lifestyle||
1089|244|N|changes that might benefit you.||
1089|245|N|   Lifestyle changes that may help reduce hot flashes include||
1089|246|N|stopping smoking, dressing lightly or in layers,||
1089|247|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
1089|248|N|reducing stress, and exercising regularly.||
1089|249|B|||
1089|250|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1089|251|D|If it is within 12 hours of the next dose, skip the missed dose.||
1089|252|D|Use your next dose at the regular time. Do not double the dose to||
1089|253|D|catch up.||
1089|254|B|||
1089|255|R|STORAGE:  Store at room temperature away from heat. Do not store||
1089|256|R|near an open flame. Keep all medications away from children and||
1089|257|R|pets.||
1089|258|R|   Do not flush medications down the toilet or pour them into a||
1089|259|R|drain unless instructed to do so. Properly discard this product||
1089|260|R|when it is expired or no longer needed. Consult your pharmacist||
1089|261|R|or local waste disposal company.||
1089|262|B|||
1089|263|A|Information last revised July 2025.||
1089|264|A|Copyright(c) 2025 First Databank, Inc.||
1089|265|B|||
1090|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1090|002|Z|does NOT have all possible information about this product. This||
1090|003|Z|information does not assure that this product is safe, effective,||
1090|004|Z|or appropriate for you. This information is not individual||
1090|005|Z|medical advice and does not substitute for the advice of your||
1090|006|Z|health care professional. Always ask your health care||
1090|007|Z|professional for complete information about this product and your||
1090|008|Z|specific health needs.||
1090|009|B|||
1090|010|T|DESVENLAFAXINE EXTENDED-RELEASE - ORAL||
1090|011|F|(des-VEN-la-FAX-een)||
1090|012|B|||
1090|013|C|COMMON BRAND NAME(S): Pristiq||
1090|014|B|||
1090|015|W|WARNING:  Antidepressant medications are used to treat a variety||
1090|016|W|of conditions, including depression and other mental/mood||
1090|017|W|disorders. These medications can help prevent suicidal||
1090|018|W|thoughts/attempts and provide other important benefits. However,||
1090|019|W|studies have shown that a small number of people (especially||
1090|020|W|people younger than 25) who take antidepressants for any||
1090|021|W|condition may experience worsening depression, other mental/mood||
1090|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
1090|023|W|talk with the doctor about the risks and benefits of||
1090|024|W|antidepressant medication (especially for people younger than||
1090|025|W|25), even if treatment is not for a mental/mood condition.||
1090|026|W|   Tell the doctor right away if you notice worsening||
1090|027|W|depression/other psychiatric conditions, unusual behavior changes||
1090|028|W|(including possible suicidal thoughts/attempts), or other||
1090|029|W|mental/mood changes (including new/worsening anxiety, panic||
1090|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1090|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
1090|032|W|especially watchful for these symptoms when a new antidepressant||
1090|033|W|is started or when the dose is changed.||
1090|034|B|||
1090|035|U|USES:  This medication is used to treat depression.||
1090|036|U|Desvenlafaxine belongs to a class of drugs known as||
1090|037|U|serotonin-norepinephrine reuptake inhibitors (SNRIs). It works by||
1090|038|U|helping to restore the balance of certain natural substances||
1090|039|U|(serotonin and norepinephrine) in the brain.||
1090|040|B|||
1090|041|V|OTHER USES:  This section contains uses of this drug that are not||
1090|042|V|listed in the approved professional labeling for the drug but||
1090|043|V|that may be prescribed by your health care professional. Use this||
1090|044|V|drug for a condition that is listed in this section only if it||
1090|045|V|has been so prescribed by your health care professional.||
1090|046|V|   This drug may also be used for anxiety, panic attacks, or hot||
1090|047|V|flashes that occur with menopause.||
1090|048|B|||
1090|049|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1090|050|H|Patient Information Leaflet provided by your pharmacist before||
1090|051|H|you start taking desvenlafaxine and each time you get a refill.||
1090|052|H|If you have any questions, ask your doctor or pharmacist.||
1090|053|H|   Take this medication by mouth with or without food as directed||
1090|054|H|by your doctor, usually once daily. The dosage is based on your||
1090|055|H|medical condition and response to treatment.||
1090|056|H|   Do not crush, chew, or dissolve this medication in water.||
1090|057|H|Doing so can release all of the drug at once, increasing the risk||
1090|058|H|of side effects. Swallow the tablets whole.||
1090|059|H|   To reduce your risk of side effects, your doctor may direct||
1090|060|H|you to start this medication at a low dose and gradually increase||
1090|061|H|your dose. Follow your doctor's instructions carefully. Do not||
1090|062|H|increase your dose or use this drug more often or for longer than||
1090|063|H|prescribed. Your condition will not improve any faster, and your||
1090|064|H|risk of side effects will increase. Use this medication regularly||
1090|065|H|to get the most benefit from it. To help you remember, use it at||
1090|066|H|the same time each day.||
1090|067|H|   Keep taking this medication even if you feel well. Do not stop||
1090|068|H|taking this medication without consulting your doctor. Some||
1090|069|H|conditions may become worse when this drug is suddenly stopped.||
1090|070|H|Also, you may experience symptoms such as mood swings, blurred||
1090|071|H|vision, headache, tiredness, sleep changes, and brief feelings||
1090|072|H|similar to electric shock. To prevent these symptoms while you||
1090|073|H|are stopping treatment with this drug, your doctor may reduce||
1090|074|H|your dose gradually. Consult your doctor or pharmacist for more||
1090|075|H|details. Report any new or worsening symptoms right away.||
1090|076|H|   If you are switching from another antidepressant to||
1090|077|H|desvenlafaxine, your doctor should slowly reduce the dose of your||
1090|078|H|old antidepressant to prevent withdrawal reactions from the other||
1090|079|H|antidepressant. Ask your doctor or pharmacist for more details.||
1090|080|H|   It may take several weeks before you get the full benefit of||
1090|081|H|this medication. Tell your doctor if your condition does not get||
1090|082|H|better or if it gets worse.||
1090|083|B|||
1090|084|S|SIDE EFFECTS:  See also Warning section.||
1090|085|S|   Drowsiness, dizziness, nausea, dry mouth, constipation, loss||
1090|086|S|of appetite, weight loss, blurred vision, nervousness, trouble||
1090|087|S|sleeping, or excessive sweating may occur. If any of these||
1090|088|S|effects last or get worse, tell your doctor or pharmacist||
1090|089|S|promptly.||
1090|090|S|   This medication may raise your blood pressure. Check your||
1090|091|S|blood pressure regularly and tell your doctor if the results are||
1090|092|S|high.||
1090|093|S|   An empty tablet shell may appear in your stool. This effect is||
1090|094|S|harmless because your body has already absorbed the medication.||
1090|095|S|   Remember that this medication has been prescribed because your||
1090|096|S|doctor has judged that the benefit to you is greater than the||
1090|097|S|risk of side effects. Many people using this medication do not||
1090|098|S|have serious side effects.||
1090|099|S|   Tell your doctor right away if you have any serious side||
1090|100|S|effects, including: severe/pounding headache, shakiness (tremor),||
1090|101|S|decreased interest in sex, changes in sexual ability, easy||
1090|102|S|bleeding/bruising.||
1090|103|S|   Get medical help right away if you have any very serious side||
1090|104|S|effects, including: cough that doesn't go away, shortness of||
1090|105|S|breath, chest pain, black stools, vomit that looks like coffee||
1090|106|S|grounds, eye pain/swelling/redness, widened pupils, vision||
1090|107|S|changes (such as seeing rainbows around lights at night),||
1090|108|S|seizures.||
1090|109|S|   This medication may increase serotonin and rarely cause a very||
1090|110|S|serious condition called serotonin syndrome/toxicity. The risk||
1090|111|S|increases if you are also taking other drugs that increase||
1090|112|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1090|113|S|take (see Drug Interactions section). Get medical help right away||
1090|114|S|if you develop some of the following symptoms: fast heartbeat,||
1090|115|S|hallucinations, loss of coordination, severe dizziness, severe||
1090|116|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1090|117|S|unusual agitation/restlessness.||
1090|118|S|   A very serious allergic reaction to this drug is rare.||
1090|119|S|However, get medical help right away if you notice any symptoms||
1090|120|S|of a serious allergic reaction, including: rash, itching/swelling||
1090|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1090|122|S|breathing.||
1090|123|S|   This is not a complete list of possible side effects. If you||
1090|124|S|notice other effects not listed above, contact your doctor or||
1090|125|S|pharmacist.||
1090|126|S|   In the US -||
1090|127|S|   Call your doctor for medical advice about side effects. You||
1090|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1090|129|S|www.fda.gov/medwatch.||
1090|130|S|   In Canada - Call your doctor for medical advice about side||
1090|131|S|effects. You may report side effects to Health Canada at||
1090|132|S|1-866-234-2345.||
1090|133|B|||
1090|134|P|PRECAUTIONS:  Before taking desvenlafaxine, tell your doctor or||
1090|135|P|pharmacist if you are allergic to it; or to venlafaxine; or if||
1090|136|P|you have any other allergies. This product may contain inactive||
1090|137|P|ingredients, which can cause allergic reactions or other||
1090|138|P|problems. Talk to your pharmacist for more details.||
1090|139|P|   Before using this medication, tell your doctor or pharmacist||
1090|140|P|your medical history, especially of: personal or family history||
1090|141|P|of psychiatric disorders (such as bipolar/manic-depressive||
1090|142|P|disorder), personal or family history of suicide attempts,||
1090|143|P|bleeding problems, personal or family history of glaucoma||
1090|144|P|(angle-closure type), high blood pressure, heart problems (such||
1090|145|P|as chest pain, heart failure, heart attack), history of stroke,||
1090|146|P|high cholesterol, kidney disease, liver disease, seizure||
1090|147|P|disorder, low sodium in the blood (hyponatremia).||
1090|148|P|   This drug may make you dizzy or drowsy or blur your vision.||
1090|149|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1090|150|P|drowsy. Do not drive, use machinery, or do anything that needs||
1090|151|P|alertness or clear vision until you can do it safely. Avoid||
1090|152|P|alcoholic beverages. Talk to your doctor if you are using||
1090|153|P|marijuana (cannabis).||
1090|154|P|   Before having surgery, tell your doctor or dentist about all||
1090|155|P|the products you use (including prescription drugs,||
1090|156|P|nonprescription drugs, and herbal products).||
1090|157|P|   Older adults may be more sensitive to the side effects of this||
1090|158|P|drug, especially dizziness when standing. Older adults may also||
1090|159|P|be more likely to develop a type of salt imbalance||
1090|160|P|(hyponatremia), especially if they are taking "water pills"||
1090|161|P|(diuretics). Dizziness and salt imbalance can increase the risk||
1090|162|P|of falling. Older adults may also be at greater risk for bleeding||
1090|163|P|while using this drug.||
1090|164|P|   Based on information for a similar drug (venlafaxine),||
1090|165|P|children may be more sensitive to the side effects of this drug,||
1090|166|P|especially loss of appetite and weight loss. Monitor height and||
1090|167|P|weight in children who are taking this drug. Consult your doctor||
1090|168|P|or pharmacist for more details.||
1090|169|P|   During pregnancy, this medication should be used only when||
1090|170|P|clearly needed. It may harm an unborn baby. Also, babies born to||
1090|171|P|mothers who have used this drug during the last 3 months of||
1090|172|P|pregnancy may rarely develop withdrawal symptoms such as||
1090|173|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
1090|174|P|constant crying. If you notice any of these symptoms in your||
1090|175|P|newborn, tell the doctor promptly.||
1090|176|P|   Since untreated mental/mood problems (such as depression,||
1090|177|P|anxiety, and panic attacks) can be a serious condition, do not||
1090|178|P|stop taking this medication unless directed by your doctor. If||
1090|179|P|you are planning pregnancy, become pregnant, or think you may be||
1090|180|P|pregnant, immediately discuss with your doctor the benefits and||
1090|181|P|risks of using this medication during pregnancy.||
1090|182|P|   This drug passes into breast milk and may have undesirable||
1090|183|P|effects on a nursing infant. Consult your doctor before||
1090|184|P|breastfeeding.||
1090|185|B|||
1090|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1090|187|I|medications work or increase your risk for serious side effects.||
1090|188|I|This document does not contain all possible drug interactions.||
1090|189|I|Keep a list of all the products you use (including||
1090|190|I|prescription/nonprescription drugs and herbal products) and share||
1090|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
1090|192|I|the dosage of any medicines without your doctor's approval.||
1090|193|I|   Some products that may interact with this drug are: other||
1090|194|I|drugs that can cause bleeding/bruising (including antiplatelet||
1090|195|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
1090|196|I|"blood thinners" such as dabigatran/warfarin).||
1090|197|I|   Aspirin can increase the risk of bleeding when used with this||
1090|198|I|medication. However, if your doctor has told you to take low-dose||
1090|199|I|aspirin to prevent heart attack or stroke (usually 81-162||
1090|200|I|milligrams a day), you should keep taking the aspirin unless your||
1090|201|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1090|202|I|details.||
1090|203|I|   Taking MAO inhibitors with this medication may cause a serious||
1090|204|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1090|205|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1090|206|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1090|207|I|selegiline, tranylcypromine) during treatment with this||
1090|208|I|medication. Most MAO inhibitors should also not be taken for two||
1090|209|I|weeks before and at least 7 days after treatment with this||
1090|210|I|medication. Ask your doctor when to start or stop taking this||
1090|211|I|medication.||
1090|212|I|   The risk of serotonin syndrome/toxicity increases if you are||
1090|213|I|also taking other drugs that increase serotonin. Examples include||
1090|214|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1090|215|I|antidepressants (including other SNRIs such as||
1090|216|I|duloxetine/milnacipran, SSRIs such as fluoxetine/paroxetine),||
1090|217|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
1090|218|I|may be more likely when you start or increase the dose of these||
1090|219|I|drugs.||
1090|220|I|   Tell your doctor or pharmacist if you are taking other||
1090|221|I|products that cause drowsiness such as opioid pain or cough||
1090|222|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1090|223|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1090|224|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1090|225|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1090|226|I|diphenhydramine).||
1090|227|I|   Check the labels on all your medicines (such as allergy or||
1090|228|I|cough-and-cold products) because they may contain ingredients||
1090|229|I|that cause drowsiness. Ask your pharmacist about using those||
1090|230|I|products safely.||
1090|231|I|   Desvenlafaxine is very similar to venlafaxine. Do not use||
1090|232|I|medications containing venlafaxine while using desvenlafaxine.||
1090|233|I|   This medication may interfere with certain lab tests||
1090|234|I|(including urine tests for amphetamines), possibly causing false||
1090|235|I|test results. Make sure lab personnel and all your doctors know||
1090|236|I|you use this drug.||
1090|237|B|||
1090|238|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1090|239|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1090|240|O|poison control center right away. US residents can call||
1090|241|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1090|242|O|Symptoms of overdose may include: severe drowsiness, seizures,||
1090|243|O|fast/irregular heartbeat.||
1090|244|B|||
1090|245|N|NOTES:  Do not share this medication with others.||
1090|246|N|   Lab and/or medical tests (such as blood pressure, cholesterol,||
1090|247|N|growth monitoring in children) should be done while you are||
1090|248|N|taking this medication. Keep all medical and lab appointments.||
1090|249|N|Consult your doctor for more details.||
1090|250|B|||
1090|251|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1090|252|D|remember. If it is near the time of the next dose, skip the||
1090|253|D|missed dose. Take your next dose at the regular time. Do not||
1090|254|D|double the dose to catch up.||
1090|255|B|||
1090|256|R|STORAGE:  Store at room temperature away from light and moisture.||
1090|257|R|Do not store in the bathroom. Keep all medications away from||
1090|258|R|children and pets.||
1090|259|R|   Do not flush medications down the toilet or pour them into a||
1090|260|R|drain unless instructed to do so. Properly discard this product||
1090|261|R|when it is expired or no longer needed. Consult your pharmacist||
1090|262|R|or local waste disposal company.||
1090|263|B|||
1090|264|A|Information last revised November 2024.||
1090|265|A|Copyright(c) 2025 First Databank, Inc.||
1090|266|B|||
1092|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1092|002|Z|does NOT have all possible information about this product. This||
1092|003|Z|information does not assure that this product is safe, effective,||
1092|004|Z|or appropriate for you. This information is not individual||
1092|005|Z|medical advice and does not substitute for the advice of your||
1092|006|Z|health care professional. Always ask your health care||
1092|007|Z|professional for complete information about this product and your||
1092|008|Z|specific health needs.||
1092|009|B|||
1092|010|T|SIMVASTATIN - ORAL||
1092|011|F|(SIM-va-STAT-in)||
1092|012|B|||
1092|013|C|COMMON BRAND NAME(S): Zocor||
1092|014|B|||
1092|015|U|USES:  Simvastatin is used along with a proper diet to help lower||
1092|016|U|"bad" cholesterol and fats (such as LDL, triglycerides) and raise||
1092|017|U|"good" cholesterol (HDL) in the blood. It belongs to a group of||
1092|018|U|drugs known as "statins." It works by reducing the amount of||
1092|019|U|cholesterol made by the liver. Lowering "bad" cholesterol and||
1092|020|U|triglycerides and raising "good" cholesterol decreases the risk||
1092|021|U|of heart disease and helps prevent strokes and heart attacks.||
1092|022|U|   In addition to eating a proper diet (such as a||
1092|023|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
1092|024|U|help this medication work better include exercising, losing||
1092|025|U|weight if overweight, and stopping smoking. Consult your doctor||
1092|026|U|for more details.||
1092|027|B|||
1092|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1092|029|H|from your pharmacist before you start taking simvastatin and each||
1092|030|H|time you get a refill. If you have any questions, ask your doctor||
1092|031|H|or pharmacist.||
1092|032|H|   Take this medication by mouth as directed by your doctor,||
1092|033|H|usually once daily in the evening. If you are using the tablet||
1092|034|H|form of this medication, you may take this medication with or||
1092|035|H|without food.||
1092|036|H|   If you are using the liquid form of this medication, take this||
1092|037|H|medication on an empty stomach. Shake the bottle well for at||
1092|038|H|least 20 seconds before each dose. Carefully measure the dose||
1092|039|H|using a special measuring device/spoon. Do not use a household||
1092|040|H|spoon because you may not get the correct dose.||
1092|041|H|   The dosage is based on your medical condition, response to||
1092|042|H|treatment, age, and other medications you may be taking. Be sure||
1092|043|H|to tell your doctor and pharmacist about all the products you use||
1092|044|H|(including prescription drugs, nonprescription drugs, and herbal||
1092|045|H|products).||
1092|046|H|   The usual maximum dose for this medication is 40 milligrams a||
1092|047|H|day. If you have been instructed by your doctor to take more than||
1092|048|H|40 milligrams, continue on that same dose. However, promptly talk||
1092|049|H|with your doctor about the risks and benefits of your higher||
1092|050|H|dose.||
1092|051|H|   Do not increase your dose or take this medication more often||
1092|052|H|than prescribed. Your condition will not improve any faster, and||
1092|053|H|the risk of serious side effects may be increased.||
1092|054|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1092|055|H|using this medication unless your doctor or pharmacist says you||
1092|056|H|may do so safely. Grapefruit can increase the chance of side||
1092|057|H|effects with this medicine. Ask your doctor or pharmacist for||
1092|058|H|more details.||
1092|059|H|   Take this medication regularly in order to get the most||
1092|060|H|benefit from it. Remember to take it at the same time each day.||
1092|061|H|Keep taking this medication even if you feel well. Most people||
1092|062|H|with high cholesterol or triglycerides do not feel sick.||
1092|063|H|   It is very important to continue to follow your doctor's||
1092|064|H|advice about diet and exercise. It may take up to 4 weeks before||
1092|065|H|you get the full benefit of this drug.||
1092|066|B|||
1092|067|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1092|068|S|because your doctor has judged that the benefit to you is greater||
1092|069|S|than the risk of side effects. Many people using this medication||
1092|070|S|do not have serious side effects.||
1092|071|S|   A very small number of people taking simvastatin may have mild||
1092|072|S|memory problems or confusion. If these rare effects occur, talk||
1092|073|S|to your doctor.||
1092|074|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
1092|075|S|doctor about the benefits and risks.||
1092|076|S|   This drug may rarely cause muscle problems (which can rarely||
1092|077|S|lead to very serious conditions called rhabdomyolysis and||
1092|078|S|autoimmune myopathy). Older adults and Chinese people may be at||
1092|079|S|higher risk. Tell your doctor right away if you develop any of||
1092|080|S|these symptoms during treatment and if these symptoms last after||
1092|081|S|your doctor stops this drug: muscle pain/tenderness/weakness||
1092|082|S|(especially with fever or unusual tiredness), signs of kidney||
1092|083|S|problems (such as change in the amount of urine).||
1092|084|S|   This medication may rarely cause liver problems. Tell your||
1092|085|S|doctor right away if you develop symptoms of liver problems,||
1092|086|S|including: nausea/vomiting that doesn't stop, yellowing||
1092|087|S|eyes/skin, dark urine, stomach/abdominal pain.||
1092|088|S|   A very serious allergic reaction to this drug is rare.||
1092|089|S|However, get medical help right away if you notice any symptoms||
1092|090|S|of a serious allergic reaction, including: rash, itching/swelling||
1092|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1092|092|S|breathing.||
1092|093|S|   This is not a complete list of possible side effects. If you||
1092|094|S|notice other effects not listed above, contact your doctor or||
1092|095|S|pharmacist.||
1092|096|S|   In the US -||
1092|097|S|   Call your doctor for medical advice about side effects. You||
1092|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1092|099|S|www.fda.gov/medwatch.||
1092|100|S|   In Canada - Call your doctor for medical advice about side||
1092|101|S|effects. You may report side effects to Health Canada at||
1092|102|S|1-866-234-2345.||
1092|103|B|||
1092|104|P|PRECAUTIONS:  Before taking simvastatin, tell your doctor or||
1092|105|P|pharmacist if you are allergic to it; or if you have any other||
1092|106|P|allergies. This product may contain inactive ingredients, which||
1092|107|P|can cause allergic reactions or other problems. Talk to your||
1092|108|P|pharmacist for more details.||
1092|109|P|   Before using this medication, tell your doctor or pharmacist||
1092|110|P|your medical history, especially of: liver disease, kidney||
1092|111|P|disease, alcohol use.||
1092|112|P|   Before having surgery, tell your doctor or dentist about all||
1092|113|P|the products you use (including prescription drugs,||
1092|114|P|nonprescription drugs, and herbal products).||
1092|115|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
1092|116|P|your risk for liver problems, especially when combined with||
1092|117|P|simvastatin. Ask your doctor or pharmacist for more information.||
1092|118|P|   Older adults may be more sensitive to the side effects of this||
1092|119|P|drug, especially muscle problems.||
1092|120|P|   During pregnancy, this medication should be used only when||
1092|121|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1092|122|P|benefits with your doctor.||
1092|123|P|   It is unknown if this medication passes into breast milk.||
1092|124|P|Because of the possible risk to the infant, breastfeeding is not||
1092|125|P|recommended while using this medication. Consult your doctor||
1092|126|P|before breastfeeding.||
1092|127|B|||
1092|128|I|DRUG INTERACTIONS:  See also How to Use section.||
1092|129|I|   Drug interactions may change how your medications work or||
1092|130|I|increase your risk for serious side effects. This document does||
1092|131|I|not contain all possible drug interactions. Keep a list of all||
1092|132|I|the products you use (including prescription/nonprescription||
1092|133|I|drugs and herbal products) and share it with your doctor and||
1092|134|I|pharmacist. Do not start, stop, or change the dosage of any||
1092|135|I|medicines without your doctor's approval.||
1092|136|I|   Some products that may interact with this drug include: "blood||
1092|137|I|thinners" (such as warfarin), cyclosporine, danazol, daptomycin,||
1092|138|I|gemfibrozil.||
1092|139|I|   Other medications can affect the removal of simvastatin from||
1092|140|I|your body, which may affect how simvastatin works. Examples||
1092|141|I|include certain azole antifungals (such as itraconazole,||
1092|142|I|ketoconazole, posaconazole, voriconazole), cobicistat,||
1092|143|I|colchicine, macrolide antibiotics (such as clarithromycin,||
1092|144|I|erythromycin), nefazodone, HIV protease inhibitors (such as||
1092|145|I|nelfinavir), ritonavir, telithromycin, among others.||
1092|146|I|   Chinese people should not take niacin at doses used to lower||
1092|147|I|cholesterol (1 gram or more) when taking this medication. Doing||
1092|148|I|so may increase the risk of side effects (especially muscle||
1092|149|I|problems). Talk with your doctor for details.||
1092|150|I|   Do not take any red yeast rice products while you are taking||
1092|151|I|simvastatin because some red yeast rice products may also contain||
1092|152|I|a statin called lovastatin. Taking simvastatin and red yeast rice||
1092|153|I|products together can increase your risk of serious muscle and||
1092|154|I|liver problems.||
1092|155|B|||
1092|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1092|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1092|158|O|poison control center right away. US residents can call||
1092|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1092|160|B|||
1092|161|N|NOTES:  Do not share this medication with others.||
1092|162|N|   Lab and/or medical tests (such as blood||
1092|163|N|cholesterol/triglyceride levels, liver function) should be done||
1092|164|N|while you are taking this medication. Keep all medical and lab||
1092|165|N|appointments. Consult your doctor for more details.||
1092|166|B|||
1092|167|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1092|168|D|remember. If it is near the time of the next dose, skip the||
1092|169|D|missed dose. Take your next dose at the regular time. Do not||
1092|170|D|double the dose to catch up.||
1092|171|B|||
1092|172|R|STORAGE:  Store at room temperature away from light and moisture.||
1092|173|R|Do not refrigerate or freeze. Do not store in the bathroom. For||
1092|174|R|the suspension form, once the bottle is opened, the medication||
1092|175|R|expires after one month. Keep all medications away from children||
1092|176|R|and pets.||
1092|177|R|   Do not flush medications down the toilet or pour them into a||
1092|178|R|drain unless instructed to do so. Properly discard this product||
1092|179|R|when it is expired or no longer needed. Consult your pharmacist||
1092|180|R|or local waste disposal company.||
1092|181|B|||
1092|182|A|Information last revised September 2024.||
1092|183|A|Copyright(c) 2025 First Databank, Inc.||
1092|184|B|||
1093|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1093|002|Z|does NOT have all possible information about this product. This||
1093|003|Z|information does not assure that this product is safe, effective,||
1093|004|Z|or appropriate for you. This information is not individual||
1093|005|Z|medical advice and does not substitute for the advice of your||
1093|006|Z|health care professional. Always ask your health care||
1093|007|Z|professional for complete information about this product and your||
1093|008|Z|specific health needs.||
1093|009|B|||
1093|010|T|CIPROFLOXACIN - INJECTION||
1093|011|F|(SIP-roe-FLOX-a-sin)||
1093|012|B|||
1093|013|C|COMMON BRAND NAME(S): Cipro||
1093|014|B|||
1093|015|W|WARNING:  Quinolone antibiotics (including ciprofloxacin) may||
1093|016|W|cause serious and possibly permanent tendon damage (such as||
1093|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
1093|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
1093|019|W|help right away if you have any of the following symptoms:||
1093|020|W|pain/numbness/burning/tingling/weakness in your||
1093|021|W|arms/hands/legs/feet, changes in how you sense||
1093|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
1093|023|W|headache, vision changes, shaking (tremors), seizures,||
1093|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
1093|025|W|hallucinations, depression, rare thoughts of suicide).||
1093|026|W|   Tendon damage may occur during or after treatment with this||
1093|027|W|medication. Stop exercising, rest, and get medical help right||
1093|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
1093|029|W|risk for tendon problems is greater if you are over 60 years of||
1093|030|W|age, if you are taking corticosteroids (such as prednisone), or||
1093|031|W|if you have a kidney, heart, or lung transplant.||
1093|032|W|   This medication may make a certain muscle condition||
1093|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
1093|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
1093|035|W|unsteady walk) or trouble breathing.||
1093|036|W|   Discuss the risks and benefits with your doctor before using||
1093|037|W|this medication.||
1093|038|B|||
1093|039|U|USES:  This medication is used to treat a variety of bacterial||
1093|040|U|infections. Ciprofloxacin belongs to a class of drugs called||
1093|041|U|quinolone antibiotics. It works by stopping the growth of||
1093|042|U|bacteria.||
1093|043|B|||
1093|044|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1093|045|H|Patient Information Leaflet provided by your pharmacist before||
1093|046|H|you start using ciprofloxacin and each time you get a refill. If||
1093|047|H|you have any questions, ask your doctor or pharmacist.||
1093|048|H|   This medication is given by injection into a vein as directed||
1093|049|H|by your doctor, usually 2 to 3 times a day. It should be injected||
1093|050|H|slowly over 1 hour. The dosage is based on your medical condition||
1093|051|H|and response to treatment. Children's dosage is also based on||
1093|052|H|weight.||
1093|053|H|   If you are giving this medication to yourself at home, learn||
1093|054|H|all preparation and usage instructions from your health care||
1093|055|H|professional. Before using, check this product for particles or||
1093|056|H|discoloration. If either is present, do not use the liquid. Learn||
1093|057|H|how to store and discard medical supplies safely.||
1093|058|H|   Drink plenty of fluids while using this medication unless your||
1093|059|H|doctor tells you otherwise.||
1093|060|H|   Ciprofloxacin may increase and/or prolong the effects of||
1093|061|H|caffeine. Avoid drinking large amounts of beverages containing||
1093|062|H|caffeine (coffee, tea, colas), eating large amounts of chocolate,||
1093|063|H|or taking nonprescription products that contain caffeine.||
1093|064|H|   For the best effect, use this antibiotic at evenly spaced||
1093|065|H|times. To help you remember, use this medication at the same||
1093|066|H|time(s) every day.||
1093|067|H|   Continue to take this medication until the full prescribed||
1093|068|H|amount is finished, even if symptoms disappear after a few days.||
1093|069|H|Stopping the medication too early may result in a return of the||
1093|070|H|infection.||
1093|071|H|   Tell your doctor if your condition lasts or gets worse.||
1093|072|B|||
1093|073|S|SIDE EFFECTS:  See also Warning section.||
1093|074|S|   Diarrhea, nausea, dizziness, lightheadedness, or trouble||
1093|075|S|sleeping may occur. If any of these effects last or get worse,||
1093|076|S|tell your doctor or pharmacist promptly.||
1093|077|S|   Remember that this medication has been prescribed because your||
1093|078|S|doctor has judged that the benefit to you is greater than the||
1093|079|S|risk of side effects. Many people using this medication do not||
1093|080|S|have serious side effects.||
1093|081|S|   Tell your doctor right away if you have any serious side||
1093|082|S|effects, including: redness/swelling/pain at the injection site,||
1093|083|S|signs of kidney problems (such as change in the amount of urine,||
1093|084|S|red/pink urine), easy or unusual bruising/bleeding, signs of a||
1093|085|S|new infection (such as sore throat that doesn't go away, fever),||
1093|086|S|signs of liver problems (such as nausea/vomiting that doesn't||
1093|087|S|stop, unusual tiredness, stomach/abdominal pain, yellowing||
1093|088|S|eyes/skin, dark urine).||
1093|089|S|   Get medical help right away if you have any very serious side||
1093|090|S|effects, including: severe dizziness, fainting, chest pain,||
1093|091|S|fast/irregular heartbeat, signs of a tear/break in the main blood||
1093|092|S|vessel called the aorta (such as sudden/severe pain in the||
1093|093|S|stomach/chest/back, shortness of breath).||
1093|094|S|   This medication may rarely cause a severe intestinal condition||
1093|095|S|due to a bacteria called C. difficile. This condition may occur||
1093|096|S|during treatment or weeks to months after treatment has stopped.||
1093|097|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1093|098|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1093|099|S|stool.||
1093|100|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1093|101|S|products because they may make symptoms worse.||
1093|102|S|   Use of this medication for prolonged or repeated periods may||
1093|103|S|result in oral thrush or a new yeast infection. Contact your||
1093|104|S|doctor if you notice white patches in your mouth, a change in||
1093|105|S|vaginal discharge, or other new symptoms.||
1093|106|S|   A very serious allergic reaction to this drug is rare.||
1093|107|S|However, get medical help right away if you notice any symptoms||
1093|108|S|of a serious allergic reaction, including: rash, itching/swelling||
1093|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1093|110|S|breathing.||
1093|111|S|   This is not a complete list of possible side effects. If you||
1093|112|S|notice other effects not listed above, contact your doctor or||
1093|113|S|pharmacist.||
1093|114|S|   In the US -||
1093|115|S|   Call your doctor for medical advice about side effects. You||
1093|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1093|117|S|www.fda.gov/medwatch.||
1093|118|S|   In Canada - Call your doctor for medical advice about side||
1093|119|S|effects. You may report side effects to Health Canada at||
1093|120|S|1-866-234-2345.||
1093|121|B|||
1093|122|P|PRECAUTIONS:  Before using ciprofloxacin, tell your doctor or||
1093|123|P|pharmacist if you are allergic to it; or to other quinolone||
1093|124|P|antibiotics (such as gatifloxacin, levofloxacin); or if you have||
1093|125|P|any other allergies. This product may contain inactive||
1093|126|P|ingredients, which can cause allergic reactions or other||
1093|127|P|problems. Talk to your pharmacist for more details.||
1093|128|P|   Before using this medication, tell your doctor or pharmacist||
1093|129|P|your medical history, especially of: seizures, conditions that||
1093|130|P|increase your risk of seizures (such as brain/head injury, brain||
1093|131|P|tumors, cerebral atherosclerosis), nerve problems (such as||
1093|132|P|peripheral neuropathy), kidney disease, liver disease,||
1093|133|P|mental/mood disorders (such as depression), myasthenia gravis,||
1093|134|P|joint/tendon problems (such as tendonitis, bursitis), heart||
1093|135|P|problems (such as slow/fast/irregular heartbeat, recent heart||
1093|136|P|attack), blood vessel problems (such as aneurysm or blockage of||
1093|137|P|the aorta or other blood vessels, hardening of the arteries),||
1093|138|P|high blood pressure, certain genetic conditions (Marfan syndrome,||
1093|139|P|Ehlers-Danlos syndrome).||
1093|140|P|   Ciprofloxacin may cause a condition that affects the heart||
1093|141|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1093|142|P|serious (rarely fatal) fast/irregular heartbeat and other||
1093|143|P|symptoms (such as severe dizziness, fainting) that need medical||
1093|144|P|attention right away.||
1093|145|P|   The risk of QT prolongation may be increased if you have||
1093|146|P|certain medical conditions or are taking other drugs that may||
1093|147|P|cause QT prolongation. Before using ciprofloxacin, tell your||
1093|148|P|doctor or pharmacist of all the drugs you take and if you have||
1093|149|P|any of the following conditions: certain heart problems (heart||
1093|150|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1093|151|P|history of certain heart problems (QT prolongation in the EKG,||
1093|152|P|sudden cardiac death).||
1093|153|P|   Low levels of potassium or magnesium in the blood may also||
1093|154|P|increase your risk of QT prolongation. This risk may increase if||
1093|155|P|you use certain drugs (such as diuretics/"water pills") or if you||
1093|156|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1093|157|P|Talk to your doctor about using ciprofloxacin safely.||
1093|158|P|   This medication may rarely cause serious changes in blood||
1093|159|P|sugar, especially if you have diabetes. Check your blood sugar||
1093|160|P|regularly as directed and share the results with your doctor.||
1093|161|P|Watch for symptoms of high blood sugar such as increased||
1093|162|P|thirst/urination. Ciprofloxacin may increase the||
1093|163|P|blood-sugar-lowering effects of the medication glyburide. Also||
1093|164|P|watch for symptoms of low blood sugar such as sudden sweating,||
1093|165|P|shaking, fast heartbeat, hunger, blurred vision, dizziness, or||
1093|166|P|tingling hands/feet. It is a good habit to carry glucose tablets||
1093|167|P|or gel to treat low blood sugar. If you don't have these reliable||
1093|168|P|forms of glucose, rapidly raise your blood sugar by eating a||
1093|169|P|quick source of sugar such as table sugar, honey, or candy, or by||
1093|170|P|drinking fruit juice or non- diet soda. Tell your doctor right||
1093|171|P|away about the reaction and the use of this product. To help||
1093|172|P|prevent low blood sugar, eat meals on a regular schedule, and do||
1093|173|P|not skip meals. Your doctor may need to switch you to another||
1093|174|P|antibiotic or adjust your diabetes medications if any reaction||
1093|175|P|occurs.||
1093|176|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1093|177|P|can make you more dizzy. Do not drive, use machinery, or do||
1093|178|P|anything that needs alertness until you can do it safely. Limit||
1093|179|P|alcoholic beverages. Talk to your doctor if you are using||
1093|180|P|marijuana (cannabis).||
1093|181|P|   This medication may make you more sensitive to the sun. Limit||
1093|182|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1093|183|P|sunscreen and wear protective clothing when outdoors. Tell your||
1093|184|P|doctor right away if you get sunburned or have skin||
1093|185|P|blisters/redness.||
1093|186|P|   Ciprofloxacin may cause live bacterial vaccines (such as||
1093|187|P|typhoid vaccine) to not work well. Tell your health care||
1093|188|P|professional that you are using ciprofloxacin before having any||
1093|189|P|immunizations/vaccinations.||
1093|190|P|   Before having surgery, tell your doctor or dentist about all||
1093|191|P|the products you use (including prescription drugs,||
1093|192|P|nonprescription drugs, and herbal products).||
1093|193|P|   Children may be more sensitive to the side effects of this||
1093|194|P|drug, especially joint/tendon problems.||
1093|195|P|   Older adults may be at greater risk for tendon problems||
1093|196|P|(especially if they are also taking corticosteroids such as||
1093|197|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
1093|198|P|tear/break in the main blood vessel (aorta).||
1093|199|P|   During pregnancy, this medication should be used only when||
1093|200|P|clearly needed. Discuss the risks and benefits with your doctor.||
1093|201|P|   This medication passes into breast milk and may have||
1093|202|P|undesirable effects on a nursing infant. Consult your doctor||
1093|203|P|before breastfeeding.||
1093|204|B|||
1093|205|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
1093|206|I|   Drug interactions may change how your medications work or||
1093|207|I|increase your risk for serious side effects. This document does||
1093|208|I|not contain all possible drug interactions. Keep a list of all||
1093|209|I|the products you use (including prescription/nonprescription||
1093|210|I|drugs and herbal products) and share it with your doctor and||
1093|211|I|pharmacist. Do not start, stop, or change the dosage of any||
1093|212|I|medicines without your doctor's approval.||
1093|213|I|   Some products that may interact with this drug include: "blood||
1093|214|I|thinners" (such as acenocoumarol, warfarin), strontium.||
1093|215|I|   Many drugs besides ciprofloxacin may affect the heart rhythm||
1093|216|I|(QT prolongation), including amiodarone, dofetilide, quinidine,||
1093|217|I|procainamide, sotalol, among others.||
1093|218|I|   This medication can slow down the removal of other medications||
1093|219|I|from your body, which may affect how they work. Examples of||
1093|220|I|affected drugs include duloxetine, fezolinetant, pirfenidone,||
1093|221|I|tasimelteon, tizanidine, vorasidenib, among others.||
1093|222|B|||
1093|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1093|224|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1093|225|O|poison control center right away. US residents can call||
1093|226|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1093|227|B|||
1093|228|N|NOTES:  If you are using this drug for a long time, lab and/or||
1093|229|N|medical tests (such as kidney/liver function, complete blood||
1093|230|N|count) should be done while you are using this medication. Keep||
1093|231|N|all medical and lab appointments. Consult your doctor for more||
1093|232|N|details.||
1093|233|B|||
1093|234|D|MISSED DOSE:  It is important to get each dose of this medication||
1093|235|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1093|236|D|right away for a new dosing schedule. Do not double the dose to||
1093|237|D|catch up.||
1093|238|B|||
1093|239|R|STORAGE:  Consult the product instructions and your pharmacist||
1093|240|R|for storage details. Keep all medications away from children and||
1093|241|R|pets.||
1093|242|R|   Do not flush medications down the toilet or pour them into a||
1093|243|R|drain unless instructed to do so. Properly discard this product||
1093|244|R|when it is expired or no longer needed. Consult your pharmacist||
1093|245|R|or local waste disposal company.||
1093|246|B|||
1093|247|A|Information last revised July 2025.||
1093|248|A|Copyright(c) 2025 First Databank, Inc.||
1093|249|B|||
1094|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1094|002|Z|does NOT have all possible information about this product. This||
1094|003|Z|information does not assure that this product is safe, effective,||
1094|004|Z|or appropriate for you. This information is not individual||
1094|005|Z|medical advice and does not substitute for the advice of your||
1094|006|Z|health care professional. Always ask your health care||
1094|007|Z|professional for complete information about this product and your||
1094|008|Z|specific health needs.||
1094|009|B|||
1094|010|T|FLUVOXAMINE EXTENDED-RELEASE - ORAL||
1094|011|F|(floo-VOX-a-meen)||
1094|012|B|||
1094|013|C|COMMON BRAND NAME(S): Luvox CR||
1094|014|B|||
1094|015|W|WARNING:  Antidepressant medications are used to treat a variety||
1094|016|W|of conditions, including depression and other mental/mood||
1094|017|W|disorders. These medications can help prevent suicidal||
1094|018|W|thoughts/attempts and provide other important benefits. However,||
1094|019|W|studies have shown that a small number of people (especially||
1094|020|W|people younger than 25) who take antidepressants for any||
1094|021|W|condition may experience worsening depression, other mental/mood||
1094|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
1094|023|W|talk with the doctor about the risks and benefits of||
1094|024|W|antidepressant medication (especially for people younger than||
1094|025|W|25), even if treatment is not for a mental/mood condition.||
1094|026|W|   Tell the doctor right away if you notice worsening||
1094|027|W|depression/other psychiatric conditions, unusual behavior changes||
1094|028|W|(including possible suicidal thoughts/attempts), or other||
1094|029|W|mental/mood changes (including new/worsening anxiety, panic||
1094|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1094|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
1094|032|W|especially watchful for these symptoms when a new antidepressant||
1094|033|W|is started or when the dose is changed.||
1094|034|B|||
1094|035|U|USES:  This medication is used to treat obsessive-compulsive||
1094|036|U|disorder (OCD). Fluvoxamine belongs to a class of drugs known as||
1094|037|U|selective serotonin reuptake inhibitors (SSRIs). It works by||
1094|038|U|helping to restore the balance of a certain natural substance||
1094|039|U|(serotonin) in the brain.||
1094|040|B|||
1094|041|V|OTHER USES:  This section contains uses of this drug that are not||
1094|042|V|listed in the approved professional labeling for the drug but||
1094|043|V|that may be prescribed by your health care professional. Use this||
1094|044|V|drug for a condition that is listed in this section only if it||
1094|045|V|has been so prescribed by your health care professional.||
1094|046|V|   This drug may also be used for anxiety disorders, depression,||
1094|047|V|post-traumatic stress disorder, or binge eating disorder (BED).||
1094|048|B|||
1094|049|H|HOW TO USE:  Read the Medication Guide provided by your||
1094|050|H|pharmacist before you start using fluvoxamine and each time you||
1094|051|H|get a refill. If you have any questions, consult your doctor or||
1094|052|H|pharmacist.||
1094|053|H|   Take this medication by mouth with or without food as directed||
1094|054|H|by your doctor, usually once daily at bedtime.||
1094|055|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
1094|056|H|Doing so can release all of the drug at once, increasing the risk||
1094|057|H|of side effects.||
1094|058|H|   The dosage is based on your medical condition, response to||
1094|059|H|treatment, age, and other medications you may be taking. Be sure||
1094|060|H|to tell your doctor and pharmacist about all the products you use||
1094|061|H|(including prescription drugs, nonprescription drugs, and herbal||
1094|062|H|products). To reduce your risk of side effects, your doctor may||
1094|063|H|direct you to start this medication at a low dose and gradually||
1094|064|H|increase your dose. Follow your doctor's instructions carefully.||
1094|065|H|   Do not increase your dose or use this drug more often or for||
1094|066|H|longer than prescribed. Your condition will not improve any||
1094|067|H|faster, and your risk of side effects will increase. Take this||
1094|068|H|medication regularly to get the most benefit from it. To help you||
1094|069|H|remember, take it at the same time(s) each day.||
1094|070|H|   Keep taking this medication even if you feel well. Do not stop||
1094|071|H|taking this medication without consulting your doctor. Some||
1094|072|H|conditions may become worse when this drug is suddenly stopped.||
1094|073|H|Also, you may experience symptoms such as mood swings, headache,||
1094|074|H|tiredness, sleep changes, and brief feelings similar to electric||
1094|075|H|shock. To prevent these symptoms while you are stopping treatment||
1094|076|H|with this drug, your doctor may reduce your dose gradually.||
1094|077|H|Consult your doctor or pharmacist for more details. Report any||
1094|078|H|new or worsening symptoms right away.||
1094|079|H|   This medication can increase the effects of caffeine. Avoid||
1094|080|H|drinking large amounts of beverages containing caffeine (coffee,||
1094|081|H|tea, colas), eating large amounts of chocolate, or taking||
1094|082|H|nonprescription products that contain caffeine.||
1094|083|H|   It may take up to several weeks before you get the full||
1094|084|H|benefit of this drug.||
1094|085|H|   Tell your doctor if your condition does not get better or if||
1094|086|H|it gets worse.||
1094|087|B|||
1094|088|S|SIDE EFFECTS:  See also Warning section.||
1094|089|S|   Nausea, vomiting, drowsiness, dizziness, loss of appetite,||
1094|090|S|trouble sleeping, weakness, and sweating may occur. If any of||
1094|091|S|these effects last or get worse, tell your doctor or pharmacist||
1094|092|S|promptly.||
1094|093|S|   Remember that this medication has been prescribed because your||
1094|094|S|doctor has judged that the benefit to you is greater than the||
1094|095|S|risk of side effects. Many people using this medication do not||
1094|096|S|have serious side effects.||
1094|097|S|   Tell your doctor right away if you have any serious side||
1094|098|S|effects, including: easy bleeding/bruising, muscle pain, shaking||
1094|099|S|(tremor), decreased interest in sex, changes in sexual ability,||
1094|100|S|pounding heartbeat.||
1094|101|S|   Get medical help right away if you have any very serious side||
1094|102|S|effects, including: fainting, irregular heartbeat, black stools,||
1094|103|S|vomit that looks like coffee grounds, seizures, eye||
1094|104|S|pain/swelling/redness, widened pupils, vision changes (such as||
1094|105|S|seeing rainbows around lights at night, blurred vision).||
1094|106|S|   This medication may increase serotonin and rarely cause a very||
1094|107|S|serious condition called serotonin syndrome/toxicity. The risk||
1094|108|S|increases if you are also taking other drugs that increase||
1094|109|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1094|110|S|take (see Drug Interactions section). Get medical help right away||
1094|111|S|if you develop some of the following symptoms: fast heartbeat,||
1094|112|S|hallucinations, loss of coordination, severe dizziness, severe||
1094|113|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1094|114|S|unusual agitation/restlessness.||
1094|115|S|   Rarely, males may have a painful or prolonged erection lasting||
1094|116|S|4 or more hours. If this occurs, stop using this drug and get||
1094|117|S|medical help right away, or permanent problems could occur.||
1094|118|S|   A very serious allergic reaction to this drug is rare.||
1094|119|S|However, get medical help right away if you notice any symptoms||
1094|120|S|of a serious allergic reaction, including: rash, itching/swelling||
1094|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1094|122|S|breathing.||
1094|123|S|   This is not a complete list of possible side effects. If you||
1094|124|S|notice other effects not listed above, contact your doctor or||
1094|125|S|pharmacist.||
1094|126|S|   In the US -||
1094|127|S|   Call your doctor for medical advice about side effects. You||
1094|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1094|129|S|www.fda.gov/medwatch.||
1094|130|S|   In Canada - Call your doctor for medical advice about side||
1094|131|S|effects. You may report side effects to Health Canada at||
1094|132|S|1-866-234-2345.||
1094|133|B|||
1094|134|P|PRECAUTIONS:  Before taking fluvoxamine, tell your doctor or||
1094|135|P|pharmacist if you are allergic to it; or if you have any other||
1094|136|P|allergies. This product may contain inactive ingredients, which||
1094|137|P|can cause allergic reactions or other problems. Talk to your||
1094|138|P|pharmacist for more details.||
1094|139|P|   Before using this medication, tell your doctor or pharmacist||
1094|140|P|your medical history, especially of: personal or family history||
1094|141|P|of bipolar/manic-depressive disorder, personal or family history||
1094|142|P|of suicide attempts, liver disease, seizures, low sodium in the||
1094|143|P|blood, bleeding problems, personal or family history of glaucoma||
1094|144|P|(angle-closure type).||
1094|145|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1094|146|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1094|147|P|machinery, or do anything that needs alertness until you can do||
1094|148|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1094|149|P|are using marijuana (cannabis).||
1094|150|P|   Fluvoxamine may cause a condition that affects the heart||
1094|151|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1094|152|P|serious (rarely fatal) fast/irregular heartbeat and other||
1094|153|P|symptoms (such as severe dizziness, fainting) that need medical||
1094|154|P|attention right away.||
1094|155|P|   The risk of QT prolongation may be increased if you have||
1094|156|P|certain medical conditions or are taking other drugs that may||
1094|157|P|cause QT prolongation. Before using fluvoxamine, tell your doctor||
1094|158|P|or pharmacist of all the drugs you take and if you have any of||
1094|159|P|the following conditions: certain heart problems (heart failure,||
1094|160|P|slow heartbeat, QT prolongation in the EKG), family history of||
1094|161|P|certain heart problems (QT prolongation in the EKG, sudden||
1094|162|P|cardiac death).||
1094|163|P|   Low levels of potassium or magnesium in the blood may also||
1094|164|P|increase your risk of QT prolongation. This risk may increase if||
1094|165|P|you use certain drugs (such as diuretics "water pills") or if you||
1094|166|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1094|167|P|Talk to your doctor about using fluvoxamine safely.||
1094|168|P|   Before having surgery, tell your doctor or dentist about all||
1094|169|P|the products you use (including prescription drugs,||
1094|170|P|nonprescription drugs, and herbal products).||
1094|171|P|   Older adults may be more sensitive to the side effects of this||
1094|172|P|drug, especially bleeding, or loss of coordination, QT||
1094|173|P|prolongation. Older adults may also be more likely to develop a||
1094|174|P|type of salt imbalance (hyponatremia), especially if they are||
1094|175|P|taking "water pills" (diuretics). Loss of coordination can||
1094|176|P|increase the risk of falling.||
1094|177|P|   Children may be more sensitive to the side effects of this||
1094|178|P|drug, especially loss of appetite and weight loss. Monitor weight||
1094|179|P|and height in children who are taking this drug.||
1094|180|P|   During pregnancy, this medication should be used only when||
1094|181|P|clearly needed. It may harm an unborn baby. Also, babies born to||
1094|182|P|mothers who have used this drug during the last 3 months of||
1094|183|P|pregnancy may rarely develop withdrawal symptoms such as||
1094|184|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
1094|185|P|constant crying. If you notice any of these symptoms in your||
1094|186|P|newborn, tell the doctor promptly.||
1094|187|P|   Since untreated mental/mood problems (such as depression,||
1094|188|P|obsessive compulsive disorder, post-traumatic stress disorder)||
1094|189|P|can be a serious condition, do not stop taking this medication||
1094|190|P|unless directed by your doctor. If you are planning pregnancy,||
1094|191|P|become pregnant, or think you may be pregnant, immediately||
1094|192|P|discuss with your doctor the benefits and risks of using this||
1094|193|P|medication during pregnancy.||
1094|194|P|   This drug passes into breast milk and may have undesirable||
1094|195|P|effects on a nursing infant. Consult your doctor before||
1094|196|P|breastfeeding.||
1094|197|B|||
1094|198|I|DRUG INTERACTIONS:  See also How to Use section.||
1094|199|I|   Drug interactions may change how your medications work or||
1094|200|I|increase your risk for serious side effects. This document does||
1094|201|I|not contain all possible drug interactions. Keep a list of all||
1094|202|I|the products you use (including prescription/nonprescription||
1094|203|I|drugs and herbal products) and share it with your doctor and||
1094|204|I|pharmacist. Do not start, stop, or change the dosage of any||
1094|205|I|medicines without your doctor's approval.||
1094|206|I|   Some products that may interact with this drug are: other||
1094|207|I|drugs that can cause bleeding/bruising (including antiplatelet||
1094|208|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
1094|209|I|"blood thinners" such as dabigatran/warfarin).||
1094|210|I|   Aspirin can increase the risk of bleeding when used with this||
1094|211|I|medication. However, if your doctor has told you to take low-dose||
1094|212|I|aspirin to prevent heart attack or stroke (usually 81-162||
1094|213|I|milligrams a day), you should keep taking the aspirin unless your||
1094|214|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1094|215|I|details.||
1094|216|I|   Many drugs besides fluvoxamine may affect the heart rhythm (QT||
1094|217|I|prolongation), including pimozide, thioridazine, among others.||
1094|218|I|   This medication can slow down the removal of other medications||
1094|219|I|from your body, which may affect how they work. Examples of||
1094|220|I|affected drugs include alosetron, clozapine, methadone,||
1094|221|I|melatonin, ramelteon, tacrine, tizanidine, vorasidenib, certain||
1094|222|I|benzodiazepines (such as alprazolam, diazepam, triazolam),||
1094|223|I|tricyclic antidepressants (such as imipramine), among others.||
1094|224|I|   Taking MAO inhibitors with this medication may cause a serious||
1094|225|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1094|226|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1094|227|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1094|228|I|selegiline, tranylcypromine) during treatment with this||
1094|229|I|medication. Most MAO inhibitors should also not be taken for two||
1094|230|I|weeks before and after treatment with this medication. Ask your||
1094|231|I|doctor when to start or stop taking this medication.||
1094|232|I|   The risk of serotonin syndrome/toxicity increases if you are||
1094|233|I|also taking other drugs that increase serotonin. Examples include||
1094|234|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1094|235|I|antidepressants (including other SSRIs such as||
1094|236|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
1094|237|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
1094|238|I|may be more likely when you start or increase the dose of these||
1094|239|I|drugs.||
1094|240|I|   Tell your doctor or pharmacist if you are taking other||
1094|241|I|products that cause drowsiness including alcohol, marijuana||
1094|242|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1094|243|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1094|244|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1094|245|I|codeine).||
1094|246|I|   Check the labels on all your medicines (such as allergy or||
1094|247|I|cough-and-cold products) because they may contain ingredients||
1094|248|I|that cause drowsiness. Ask your pharmacist about using those||
1094|249|I|products safely.||
1094|250|I|   Cigarette smoking decreases blood levels of this medication.||
1094|251|I|Tell your doctor if you smoke or if you have recently stopped||
1094|252|I|smoking.||
1094|253|I|   This medication may interfere with certain medical/lab tests||
1094|254|I|(such as brain scan for Parkinson's disease), possibly causing||
1094|255|I|false test results. Make sure lab personnel and all your doctors||
1094|256|I|know you use this drug.||
1094|257|B|||
1094|258|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1094|259|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1094|260|O|poison control center right away. US residents can call||
1094|261|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1094|262|O|Symptoms of overdose may include: fast/slow/irregular heartbeat,||
1094|263|O|trouble breathing, seizures.||
1094|264|B|||
1094|265|N|NOTES:  Do not share this medication with others.||
1094|266|N|   Keep all medical and lab appointments.||
1094|267|B|||
1094|268|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1094|269|D|remember. If it is near the time of the next dose, skip the||
1094|270|D|missed dose. Take your next dose at the regular time. Do not||
1094|271|D|double the dose to catch up.||
1094|272|B|||
1094|273|R|STORAGE:  Store at room temperature away from light and moisture.||
1094|274|R|Do not store in the bathroom. Keep all medications away from||
1094|275|R|children and pets.||
1094|276|R|   Do not flush medications down the toilet or pour them into a||
1094|277|R|drain unless instructed to do so. Properly discard this product||
1094|278|R|when it is expired or no longer needed. Consult your pharmacist||
1094|279|R|or local waste disposal company.||
1094|280|B|||
1094|281|A|Information last revised July 2025.||
1094|282|A|Copyright(c) 2025 First Databank, Inc.||
1094|283|B|||
1096|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1096|002|Z|does NOT have all possible information about this product. This||
1096|003|Z|information does not assure that this product is safe, effective,||
1096|004|Z|or appropriate for you. This information is not individual||
1096|005|Z|medical advice and does not substitute for the advice of your||
1096|006|Z|health care professional. Always ask your health care||
1096|007|Z|professional for complete information about this product and your||
1096|008|Z|specific health needs.||
1096|009|B|||
1096|010|T|NON-OPIOID ANTITUSSIVE W/DECONGESTANT - ORAL||
1096|011|B|||
1096|012|U|USES:  This combination product is used for the temporary||
1096|013|U|treatment of cough, stuffy nose, and sinus pain/pressure caused||
1096|014|U|by infection (such as the common cold, flu) or other breathing||
1096|015|U|illnesses (such as hay fever, bronchitis). This product contains||
1096|016|U|a decongestant (such as pseudoephedrine, phenylephrine) that||
1096|017|U|works by narrowing the blood vessels to help relieve stuffy nose||
1096|018|U|symptoms and sinus pressure. This product also contains a||
1096|019|U|non-opioid cough suppressant (such as dextromethorphan,||
1096|020|U|chlophedianol). It affects a certain part of the brain (cough||
1096|021|U|center) to help you stop coughing. Talk with your doctor before||
1096|022|U|using this product for a chronic cough from smoking or a cough||
1096|023|U|with too much/thick mucus.||
1096|024|U|   Cough-and-cold products have not been shown to be safe or||
1096|025|U|effective in children younger than 6 years. Do not use this||
1096|026|U|product to treat cold symptoms in children younger than 6 years||
1096|027|U|unless specifically directed by the doctor. Some products (such||
1096|028|U|as long-acting tablets/capsules) are not recommended for use in||
1096|029|U|children younger than 12 years. Ask your doctor or pharmacist for||
1096|030|U|more details about using your product safely.||
1096|031|U|   These products do not cure or shorten the length of the common||
1096|032|U|cold and may cause serious side effects. To decrease the risk for||
1096|033|U|serious side effects, carefully follow all dosage directions. Do||
1096|034|U|not use this product to make a child sleepy. Do not give other||
1096|035|U|cough-and-cold medication that might contain the same or similar||
1096|036|U|ingredients (see also Drug Interactions section). Ask the doctor||
1096|037|U|or pharmacist about other ways to relieve cough and cold symptoms||
1096|038|U|(such as drinking enough fluids, using a humidifier or saline||
1096|039|U|nose drops/spray).||
1096|040|B|||
1096|041|H|HOW TO USE:  If you are taking the over-the-counter product to||
1096|042|H|self-treat, follow all directions on the product package before||
1096|043|H|taking this medication. If you have any questions, ask your||
1096|044|H|doctor or pharmacist. If your doctor has prescribed this||
1096|045|H|medication, take it as directed.||
1096|046|H|   Take the tablet, capsule, or liquid form by mouth with or||
1096|047|H|without food. This medication may be taken with food or milk if||
1096|048|H|stomach upset occurs.||
1096|049|H|   The dosage is based on your age, medical condition, and||
1096|050|H|response to treatment. Do not increase your dose or take this||
1096|051|H|drug more often than directed. Do not take more of this||
1096|052|H|medication than recommended for your age. There are many brands||
1096|053|H|and forms of this product available. Read the dosing instructions||
1096|054|H|carefully for each product because the amount of cough||
1096|055|H|suppressant and decongestant may be different between products.||
1096|056|H|   If you are using the chewable tablets, chew each tablet well||
1096|057|H|and swallow. If you are using the liquid form of this medication,||
1096|058|H|measure the dose carefully using a special measuring device/cup.||
1096|059|H|Do not use a household spoon because you may not get the correct||
1096|060|H|dose.||
1096|061|H|   If you are using a product made to dissolve in the mouth (such||
1096|062|H|as strips), dry your hands before handling the medication. Place||
1096|063|H|each dose on the tongue and allow to dissolve completely, then||
1096|064|H|swallow it with saliva or with water.||
1096|065|H|   Caffeine can increase the side effects of this medication.||
1096|066|H|Avoid drinking large amounts of beverages containing caffeine||
1096|067|H|(coffee, tea, colas), eating large amounts of chocolate, or||
1096|068|H|taking nonprescription products that contain caffeine.||
1096|069|H|   Improper use of dextromethorphan (abuse) may result in serious||
1096|070|H|harm (such as brain damage, seizure, death). Do not increase your||
1096|071|H|dose, take it more often, or use it for a longer time than||
1096|072|H|directed.||
1096|073|H|   Tell your doctor if your symptoms do not get better after 7||
1096|074|H|days or if they get worse or return, or if you have a headache||
1096|075|H|that doesn't go away, fever, or rash. If you think you may have a||
1096|076|H|serious medical problem, get medical help right away.||
1096|077|B|||
1096|078|S|SIDE EFFECTS:  Nausea, vomiting, trouble sleeping, dizziness,||
1096|079|S|headache, or nervousness may occur. If any of these effects last||
1096|080|S|or get worse, tell your doctor or pharmacist promptly. Stop||
1096|081|S|taking this medication and tell your doctor promptly if you have||
1096|082|S|dizziness, nervousness, or trouble sleeping.||
1096|083|S|   If your doctor has directed you to use this medication,||
1096|084|S|remember that your doctor has judged that the benefit to you is||
1096|085|S|greater than the risk of side effects. Many people using this||
1096|086|S|medication do not have serious side effects.||
1096|087|S|   This medication may raise your blood pressure. Check your||
1096|088|S|blood pressure regularly and tell your doctor if the results are||
1096|089|S|high.||
1096|090|S|   Stop taking this medication and tell your doctor right away if||
1096|091|S|you have any serious side effects, including:||
1096|092|S|fast/irregular/pounding heartbeat, mental/mood changes (such as||
1096|093|S|confusion, hallucinations, nervousness), seizures, shaking||
1096|094|S|(tremors), trouble urinating.||
1096|095|S|   A very serious allergic reaction to this drug is rare.||
1096|096|S|However, get medical help right away if you notice any symptoms||
1096|097|S|of a serious allergic reaction, including: rash, itching/swelling||
1096|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1096|099|S|breathing.||
1096|100|S|   This is not a complete list of possible side effects. If you||
1096|101|S|notice other effects not listed above, contact your doctor or||
1096|102|S|pharmacist.||
1096|103|S|   In the US -||
1096|104|S|   Call your doctor for medical advice about side effects. You||
1096|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1096|106|S|www.fda.gov/medwatch.||
1096|107|S|   In Canada - Call your doctor for medical advice about side||
1096|108|S|effects. You may report side effects to Health Canada at||
1096|109|S|1-866-234-2345.||
1096|110|B|||
1096|111|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1096|112|P|pharmacist if you are allergic to it; or if you have any other||
1096|113|P|allergies. Also tell your doctor if you have had negative||
1096|114|P|reactions to any sympathomimetics (such as pseudoephedrine,||
1096|115|P|phenylephrine). This product may contain inactive ingredients,||
1096|116|P|which can cause allergic reactions or other problems. Talk to||
1096|117|P|your pharmacist for more details.||
1096|118|P|   If you have any of the following health problems, consult your||
1096|119|P|doctor or pharmacist before using this product: couch with a lot||
1096|120|P|of mucus, chronic cough (such as with asthma, emphysema,||
1096|121|P|smoking), diabetes, a certain eye condition (glaucoma), heart||
1096|122|P|problems (such as heart attack, chest pain, heart failure),||
1096|123|P|fast/irregular heart beat, high blood pressure, liver disease,||
1096|124|P|kidney problems, overactive thyroid (hyperthyroidism), difficulty||
1096|125|P|urinating (such as due to enlarged prostate).||
1096|126|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1096|127|P|can make you more dizzy. Do not drive, use machinery, or do||
1096|128|P|anything that needs alertness until you can do it safely. Limit||
1096|129|P|alcoholic beverages. Talk to your doctor if you are using||
1096|130|P|marijuana (cannabis).||
1096|131|P|   Liquid forms, chewable tablets, or forms of this product made||
1096|132|P|to dissolve in the mouth may contain sugar, alcohol, or||
1096|133|P|aspartame. Caution is advised if you have diabetes, alcohol||
1096|134|P|dependence, liver disease, phenylketonuria (PKU), or any other||
1096|135|P|condition that requires you to limit/avoid these substances in||
1096|136|P|your diet. Ask your doctor or pharmacist about using this product||
1096|137|P|safely.||
1096|138|P|   Before having surgery, tell your doctor or dentist about all||
1096|139|P|the products you use (including prescription drugs,||
1096|140|P|nonprescription drugs, and herbal products).||
1096|141|P|   Older adults may be more sensitive to the side effects of this||
1096|142|P|drug, especially fast/irregular heartbeat, dizziness, problems||
1096|143|P|urinating, trouble sleeping, or confusion.||
1096|144|P|   Children may be more sensitive to the effects of this||
1096|145|P|medication, especially agitation.||
1096|146|P|   During pregnancy, this medication should be used only when||
1096|147|P|clearly needed. Discuss the risks and benefits with your doctor.||
1096|148|P|   This medication may pass into breast milk. Consult your doctor||
1096|149|P|before breastfeeding.||
1096|150|B|||
1096|151|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1096|152|I|medications work or increase your risk for serious side effects.||
1096|153|I|This document does not contain all possible drug interactions.||
1096|154|I|Keep a list of all the products you use (including||
1096|155|I|prescription/nonprescription drugs and herbal products) and share||
1096|156|I|it with your doctor and pharmacist. Do not start, stop, or change||
1096|157|I|the dosage of any medicines without your doctor's approval.||
1096|158|I|   Taking certain MAO inhibitors with this medication may cause a||
1096|159|I|serious (possibly fatal) drug interaction. Avoid taking||
1096|160|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
1096|161|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
1096|162|I|tranylcypromine during treatment with this medication. Most MAO||
1096|163|I|inhibitors should also not be taken for two weeks before||
1096|164|I|treatment with this medication. Ask your doctor when to start or||
1096|165|I|stop taking this medication.||
1096|166|I|   Check the labels on all your medicines (such as allergy or||
1096|167|I|cough-and-cold products) because they may contain similar||
1096|168|I|ingredients (decongestants such as phenylephrine or cough||
1096|169|I|suppressants). Ask your pharmacist about using those products||
1096|170|I|safely.||
1096|171|B|||
1096|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1096|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1096|174|O|poison control center right away. US residents can call||
1096|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1096|176|O|Symptoms of overdose may include: agitation, confusion,||
1096|177|O|hallucinations, seizures.||
1096|178|B|||
1096|179|N|NOTES:  This medication is for temporary use only. Do not use for||
1096|180|N|more than 7 days without first consulting your doctor.||
1096|181|B|||
1096|182|D|MISSED DOSE:  If you are taking this product on a regular||
1096|183|D|schedule and miss a dose, take it as soon as you remember. If it||
1096|184|D|is near the time of the next dose, skip the missed dose. Take||
1096|185|D|your next dose at the regular time. Do not double the dose to||
1096|186|D|catch up.||
1096|187|B|||
1096|188|R|STORAGE:  Different brands of this medication have different||
1096|189|R|storage needs. Check the product package for instructions on how||
1096|190|R|to store your brand, or ask your pharmacist. Keep all medications||
1096|191|R|away from children and pets.||
1096|192|R|   Do not flush medications down the toilet or pour them into a||
1096|193|R|drain unless instructed to do so. Properly discard this product||
1096|194|R|when it is expired or no longer needed. Consult your pharmacist||
1096|195|R|or local waste disposal company.||
1096|196|B|||
1096|197|A|Information last revised July 2025.||
1096|198|A|Copyright(c) 2025 First Databank, Inc.||
1096|199|B|||
1098|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1098|002|Z|does NOT have all possible information about this product. This||
1098|003|Z|information does not assure that this product is safe, effective,||
1098|004|Z|or appropriate for you. This information is not individual||
1098|005|Z|medical advice and does not substitute for the advice of your||
1098|006|Z|health care professional. Always ask your health care||
1098|007|Z|professional for complete information about this product and your||
1098|008|Z|specific health needs.||
1098|009|B|||
1098|010|T|RILONACEPT - INJECTION||
1098|011|F|(ri-LON-a-sept)||
1098|012|B|||
1098|013|C|COMMON BRAND NAME(S): Arcalyst||
1098|014|B|||
1098|015|U|USES:  Rilonacept is used to treat a certain type heart disease||
1098|016|U|(recurrent pericarditis). This medication reduces the risk of the||
1098|017|U|heart disease from coming back.||
1098|018|U|   This medication is also used to treat a certain group of||
1098|019|U|inherited disorders called cryopyrin-associated periodic||
1098|020|U|syndromes (CAPS), including familial cold autoinflammatory||
1098|021|U|syndrome and Muckle-Wells syndrome. Rilonacept works by blocking||
1098|022|U|a certain natural protein in your body (interleukin-1) that may||
1098|023|U|worsen the symptoms of CAPS. Rilonacept does not cure CAPS, but||
1098|024|U|it can help lessen the symptoms, including rash, joint pain,||
1098|025|U|fever, and tiredness.||
1098|026|U|   This medication is also used to treat a condition of a lack of||
1098|027|U|the natural protein interleukin-1 receptor antagonist (Deficiency||
1098|028|U|of Interleukin-1 Receptor Antagonist-DIRA).||
1098|029|B|||
1098|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1098|031|H|from your pharmacist before you start using rilonacept and each||
1098|032|H|time you get a refill. Ask your health care professional how to||
1098|033|H|prepare and use this medication. If you have any questions, ask||
1098|034|H|your doctor or pharmacist.||
1098|035|H|   Inject this medication under the skin as directed by your||
1098|036|H|doctor, usually once weekly. The injection is given in the thigh,||
1098|037|H|abdomen, or upper arm. The dosage is based on your age, weight,||
1098|038|H|medical condition, and response to treatment.||
1098|039|H|   Before using, check this product for particles or||
1098|040|H|discoloration. If either is present, do not use the liquid.||
1098|041|H|Before injecting each dose, clean the skin you are going to||
1098|042|H|inject into (the injection site) with rubbing alcohol. Change the||
1098|043|H|injection site each time to lessen injury under the skin. Do not||
1098|044|H|inject into skin that is tender, red, or hard. To lessen||
1098|045|H|bruising, do not rub the injection site after a shot. Learn how||
1098|046|H|to store and discard medical supplies safely.||
1098|047|H|   Use this medication regularly to get the most benefit from it.||
1098|048|H|To help you remember, use it on the same day each week. Mark your||
1098|049|H|calendar with a reminder.||
1098|050|H|   Tell your doctor if your condition does not get better or if||
1098|051|H|it gets worse.||
1098|052|B|||
1098|053|S|SIDE EFFECTS:  Bruising, itching, pain, redness, swelling, or||
1098|054|S|hardening of the skin at the injection site may occur. Injection||
1098|055|S|site reactions usually go away after 1 or 2 days. If any of these||
1098|056|S|effects last or get worse, tell your doctor or pharmacist||
1098|057|S|promptly.||
1098|058|S|   Remember that this medication has been prescribed because your||
1098|059|S|doctor has judged that the benefit to you is greater than the||
1098|060|S|risk of side effects. Many people using this medication do not||
1098|061|S|have serious side effects.||
1098|062|S|   This medication may lower your ability to fight infections.||
1098|063|S|This may make you more likely to get a serious infection or make||
1098|064|S|any infection you have worse. Tell your doctor right away if you||
1098|065|S|have any signs of infection (such as sore throat that doesn't go||
1098|066|S|away, fever, chills).||
1098|067|S|   This medication can affect the amount of cholesterol and other||
1098|068|S|fats (lipids) in your blood. Your doctor may periodically order||
1098|069|S|lab tests to monitor this side effect and prescribe treatment if||
1098|070|S|needed.||
1098|071|S|   A very serious allergic reaction to this drug is rare.||
1098|072|S|However, get medical help right away if you notice any symptoms||
1098|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1098|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1098|075|S|breathing.||
1098|076|S|   This is not a complete list of possible side effects. If you||
1098|077|S|notice other effects not listed above, contact your doctor or||
1098|078|S|pharmacist.||
1098|079|S|   In the US -||
1098|080|S|   Call your doctor for medical advice about side effects. You||
1098|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1098|082|S|www.fda.gov/medwatch.||
1098|083|S|   In Canada - Call your doctor for medical advice about side||
1098|084|S|effects. You may report side effects to Health Canada at||
1098|085|S|1-866-234-2345.||
1098|086|B|||
1098|087|P|PRECAUTIONS:  Before using rilonacept, tell your doctor or||
1098|088|P|pharmacist if you are allergic to it; or if you have any other||
1098|089|P|allergies. This product may contain inactive ingredients, which||
1098|090|P|can cause allergic reactions or other problems. Talk to your||
1098|091|P|pharmacist for more details.||
1098|092|P|   Before using this medication, tell your doctor or pharmacist||
1098|093|P|your medical history, especially of: breathing problems (such as||
1098|094|P|asthma), cancer, cuts or open sores, diabetes, immune system||
1098|095|P|problems (such as HIV infection), current/recent/returning||
1098|096|P|infection (including hepatitis and tuberculosis).||
1098|097|P|   Rilonacept can make you more likely to get infections or may||
1098|098|P|make current infections worse. Stay away from anyone who has an||
1098|099|P|infection that may easily spread (such as chickenpox, COVID-19,||
1098|100|P|measles, flu). Talk to your doctor if you have been exposed to an||
1098|101|P|infection or for more details.||
1098|102|P|   Tell your health care professional that you are using||
1098|103|P|rilonacept before having any immunizations/vaccinations. Avoid||
1098|104|P|contact with people who have recently received live vaccines||
1098|105|P|(such as flu vaccine inhaled through the nose).||
1098|106|P|   Before having surgery, tell your doctor or dentist about all||
1098|107|P|the products you use (including prescription drugs,||
1098|108|P|nonprescription drugs, and herbal products).||
1098|109|P|   During pregnancy, this medication should be used only when||
1098|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
1098|111|P|   It is unknown if this drug passes into breast milk. Consult||
1098|112|P|your doctor before breastfeeding.||
1098|113|B|||
1098|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1098|115|I|medications work or increase your risk for serious side effects.||
1098|116|I|This document does not contain all possible drug interactions.||
1098|117|I|Keep a list of all the products you use (including||
1098|118|I|prescription/nonprescription drugs and herbal products) and share||
1098|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
1098|120|I|the dosage of any medicines without your doctor's approval.||
1098|121|I|   Some products that may interact with this drug include:||
1098|122|I|anti-cancer drugs, corticosteroids, drugs that block tumor||
1098|123|I|necrosis factor-TNF (such as adalimumab, etanercept, infliximab),||
1098|124|I|other drugs that block interleukin-1 (such as anakinra).||
1098|125|B|||
1098|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1098|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1098|128|O|poison control center right away. US residents can call||
1098|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1098|130|B|||
1098|131|N|NOTES:  Do not share this medication with others.||
1098|132|N|   Lab and/or medical tests (such as cholesterol, C-reactive||
1098|133|N|protein, serum amyloid A) may be done while you are using this||
1098|134|N|medication. Keep all medical and lab appointments. Consult your||
1098|135|N|doctor for more details.||
1098|136|B|||
1098|137|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1098|138|D|If it is less than 24 hours before the next dose, skip the missed||
1098|139|D|dose. Use your next dose at the regular time. Do not double the||
1098|140|D|dose to catch up.||
1098|141|B|||
1098|142|R|STORAGE:  Store the unmixed vial in the refrigerator. Keep the||
1098|143|R|medication in the original carton to protect from light. After||
1098|144|R|mixing, store at room temperature away from light. Use within 3||
1098|145|R|hours of mixing, and discard any unused portion. Keep all||
1098|146|R|medications away from children and pets.||
1098|147|R|   Do not flush medications down the toilet or pour them into a||
1098|148|R|drain unless instructed to do so. Properly discard this product||
1098|149|R|when it is expired or no longer needed. Consult your pharmacist||
1098|150|R|or local waste disposal company.||
1098|151|B|||
1098|152|A|Information last revised April 2025.||
1098|153|A|Copyright(c) 2025 First Databank, Inc.||
1098|154|B|||
1099|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1099|002|Z|does NOT have all possible information about this product. This||
1099|003|Z|information does not assure that this product is safe, effective,||
1099|004|Z|or appropriate for you. This information is not individual||
1099|005|Z|medical advice and does not substitute for the advice of your||
1099|006|Z|health care professional. Always ask your health care||
1099|007|Z|professional for complete information about this product and your||
1099|008|Z|specific health needs.||
1099|009|B|||
1099|010|T|CICLESONIDE SPRAY - NASAL||
1099|011|F|(sye-KLES-oh-nide)||
1099|012|B|||
1099|013|C|COMMON BRAND NAME(S): Omnaris||
1099|014|B|||
1099|015|U|USES:  This medication is used to treat symptoms of the nose||
1099|016|U|(stuffiness or congestion, runny nose, itching, and sneezing)||
1099|017|U|caused by seasonal and year-round nasal allergies. Ciclesonide||
1099|018|U|works by reducing the swelling (inflammation) of the nasal||
1099|019|U|passages. It belongs to the class of drugs known as||
1099|020|U|corticosteroids.||
1099|021|B|||
1099|022|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1099|023|H|your pharmacist before you start using ciclesonide and each time||
1099|024|H|you get a refill. If you have any questions, ask your doctor or||
1099|025|H|pharmacist.||
1099|026|H|   Gently blow your nose before using this drug. Shake the||
1099|027|H|container gently before each use. Remove the dust cap. Follow the||
1099|028|H|instructions on how to properly prime the bottle when you first||
1099|029|H|use each bottle or if you have not used it for 4 days. A fine||
1099|030|H|spray means that the pump is primed properly.||
1099|031|H|   Use this medication as directed by your doctor, usually once a||
1099|032|H|day. Do not use more than 2 sprays in each nostril daily as this||
1099|033|H|may increase the risk of side effects. Avoid spraying this||
1099|034|H|medication in your eyes or directly onto the nasal septum (the||
1099|035|H|wall between the two nostrils). Follow the detailed instructions||
1099|036|H|for using the spray.||
1099|037|H|   After each use, wipe the spray tip with a clean tissue and||
1099|038|H|replace the protective cap. If the spray tip becomes blocked, do||
1099|039|H|not try to unblock the nasal applicator by using a sharp object.||
1099|040|H|Look at the Patient Information Leaflet to learn how to correctly||
1099|041|H|unblock the spray bottle.||
1099|042|H|   Use this medication regularly to get the most benefit from it.||
1099|043|H|To help you remember, use it at the same time each day.||
1099|044|H|   This medication does not work right away. Some people will||
1099|045|H|feel this medication working within 2 days, but it may take up to||
1099|046|H|2 weeks for seasonal allergy relief, and up to 5 weeks for||
1099|047|H|year-round allergy relief. When using ciclesonide to prevent||
1099|048|H|seasonal allergy symptoms, start this medication 2-4 weeks before||
1099|049|H|pollen season begins.||
1099|050|H|   Keep track of the number of sprays used from each container.||
1099|051|H|Discard the container after you have used the number of sprays||
1099|052|H|specified on the manufacturer's package or 4 months after you||
1099|053|H|removed the bottle from the foil pouch it came in, whichever||
1099|054|H|comes first.||
1099|055|H|   Tell your doctor if your condition lasts or gets worse.||
1099|056|B|||
1099|057|S|SIDE EFFECTS:  Nosebleeds, irritation of the nose, or ear pain||
1099|058|S|may occur. If any of these effects last or get worse, tell your||
1099|059|S|doctor or pharmacist promptly.||
1099|060|S|   Remember that this medication has been prescribed because your||
1099|061|S|doctor has judged that the benefit to you is greater than the||
1099|062|S|risk of side effects. Many people using this medication do not||
1099|063|S|have serious side effects.||
1099|064|S|   Rarely, it is possible that corticosteroids given in the nose||
1099|065|S|will be absorbed into the bloodstream. This can lead to side||
1099|066|S|effects of too much corticosteroid. These side effects are more||
1099|067|S|likely in children and people who use this medication for a long||
1099|068|S|time and in high doses. Tell your doctor right away if any of the||
1099|069|S|following side effects occur: unusual/extreme tiredness, weight||
1099|070|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
1099|071|S|vision problems.||
1099|072|S|   Using corticosteroids in the nose for a long time may rarely||
1099|073|S|cause fungal infections of the nose or throat. Tell your doctor||
1099|074|S|right away if you develop any of the following: fever, pain in||
1099|075|S|the nose, severe sore throat, pain when swallowing, white patches||
1099|076|S|on the back of the throat.||
1099|077|S|   Tell your doctor right away if you have any serious side||
1099|078|S|effects, including: severe nosebleeds, severe pain in the nose,||
1099|079|S|whistling sound while breathing, eye pain.||
1099|080|S|   A very serious allergic reaction to this drug is rare.||
1099|081|S|However, get medical help right away if you notice any symptoms||
1099|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1099|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1099|084|S|breathing.||
1099|085|S|   This is not a complete list of possible side effects. If you||
1099|086|S|notice other effects not listed above, contact your doctor or||
1099|087|S|pharmacist.||
1099|088|S|   In the US -||
1099|089|S|   Call your doctor for medical advice about side effects. You||
1099|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1099|091|S|www.fda.gov/medwatch.||
1099|092|S|   In Canada - Call your doctor for medical advice about side||
1099|093|S|effects. You may report side effects to Health Canada at||
1099|094|S|1-866-234-2345.||
1099|095|B|||
1099|096|P|PRECAUTIONS:  Before using ciclesonide, tell your doctor or||
1099|097|P|pharmacist if you are allergic to it; or if you have any other||
1099|098|P|allergies. This product may contain inactive ingredients, which||
1099|099|P|can cause allergic reactions or other problems. Talk to your||
1099|100|P|pharmacist for more details.||
1099|101|P|   Before using this medication, tell your doctor or pharmacist||
1099|102|P|your medical history, especially of: recent nose problems (such||
1099|103|P|as injury, ulcers, surgery), current/past infections (including||
1099|104|P|tuberculosis, herpes eye infection), certain eye problems||
1099|105|P|(glaucoma, cataracts).||
1099|106|P|   Stay away from anyone who has an infection that may easily||
1099|107|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1099|108|P|doctor if you have been exposed to an infection or for more||
1099|109|P|details.||
1099|110|P|   Rarely, using corticosteroid medications for a long time can||
1099|111|P|make it more difficult for your body to respond to physical||
1099|112|P|stress. Before having surgery or emergency treatment, or if you||
1099|113|P|get a serious illness/injury, tell your doctor or dentist that||
1099|114|P|you are using this medication or have used this medication within||
1099|115|P|the past few months.||
1099|116|P|   Though it is unlikely, this medication may temporarily slow||
1099|117|P|down a child's growth if used for a long time. See the doctor||
1099|118|P|regularly so your child's height can be checked.||
1099|119|P|   During pregnancy, this medication should be used only when||
1099|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
1099|121|P|   It is unknown if this drug passes into breast milk. Consult||
1099|122|P|your doctor before breastfeeding.||
1099|123|B|||
1099|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1099|125|I|medications work or increase your risk for serious side effects.||
1099|126|I|This document does not contain all possible drug interactions.||
1099|127|I|Keep a list of all the products you use (including||
1099|128|I|prescription/nonprescription drugs and herbal products) and share||
1099|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
1099|130|I|the dosage of any medicines without your doctor's approval.||
1099|131|B|||
1099|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1099|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1099|134|O|poison control center right away. US residents can call||
1099|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1099|136|B|||
1099|137|N|NOTES:  Do not share this medication with others.||
1099|138|N|   If you use this medication for a long time, lab and/or medical||
1099|139|N|tests (such as nose exams, height measurement in children) may be||
1099|140|N|done while you are using this medication. Keep all medical and||
1099|141|N|lab appointments. Consult your doctor for more details.||
1099|142|N|   Ask your doctor for ways to reduce your exposure to substances||
1099|143|N|(such as pollen, pet dander, dust mites, mold, smoke) that can||
1099|144|N|worsen allergy symptoms.||
1099|145|B|||
1099|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1099|147|D|If it is near the time of the next dose, skip the missed dose.||
1099|148|D|Use your next dose at the regular time. Do not double the dose to||
1099|149|D|catch up.||
1099|150|B|||
1099|151|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
1099|152|R|medications away from children and pets.||
1099|153|R|   Do not flush medications down the toilet or pour them into a||
1099|154|R|drain unless instructed to do so. Properly discard this product||
1099|155|R|when it is expired or no longer needed. Consult your pharmacist||
1099|156|R|or local waste disposal company.||
1099|157|B|||
1099|158|A|Information last revised May 2024.||
1099|159|A|Copyright(c) 2025 First Databank, Inc.||
1099|160|B|||
1100|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1100|002|Z|does NOT have all possible information about this product. This||
1100|003|Z|information does not assure that this product is safe, effective,||
1100|004|Z|or appropriate for you. This information is not individual||
1100|005|Z|medical advice and does not substitute for the advice of your||
1100|006|Z|health care professional. Always ask your health care||
1100|007|Z|professional for complete information about this product and your||
1100|008|Z|specific health needs.||
1100|009|B|||
1100|010|T|SUMATRIPTAN/NAPROXEN - ORAL||
1100|011|F|(SOO-ma-TRIP-tan/na-PROX-en)||
1100|012|B|||
1100|013|C|COMMON BRAND NAME(S): Treximet||
1100|014|B|||
1100|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1100|016|W|naproxen) may rarely increase the risk for a heart attack or||
1100|017|W|stroke. This effect can happen at any time while taking this drug||
1100|018|W|but is more likely if you take it for a long time. The risk may||
1100|019|W|be greater in older adults or if you have heart disease or||
1100|020|W|increased risk for heart disease (for example, due to smoking,||
1100|021|W|family history of heart disease, or conditions such as high blood||
1100|022|W|pressure or diabetes). Do not take this drug right before or||
1100|023|W|after heart bypass surgery (CABG).||
1100|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
1100|025|W|from the stomach or intestines. This effect can occur without||
1100|026|W|warning at any time while taking this drug. Older adults may be||
1100|027|W|at higher risk for this effect.||
1100|028|W|   Stop taking this medication and get medical help right away if||
1100|029|W|you notice any of these rare but serious side effects:||
1100|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
1100|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1100|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
1100|033|W|side of the body, trouble speaking, sudden vision changes.||
1100|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
1100|035|W|of taking this drug.||
1100|036|B|||
1100|037|U|USES:  This combination product contains two ingredients:||
1100|038|U|naproxen and sumatriptan. It helps to relieve headache, pain, and||
1100|039|U|other migraine symptoms (including nausea, vomiting, sensitivity||
1100|040|U|to light/sound) in adults and in children 12 years or older.||
1100|041|U|Prompt treatment helps you return to your normal routine and may||
1100|042|U|decrease your need for other pain medications.||
1100|043|U|   Naproxen is known as a nonsteroidal anti-inflammatory drug||
1100|044|U|(NSAID). It is used to relieve pain. Sumatriptan belongs to a||
1100|045|U|class of drugs called triptans. It affects a certain natural||
1100|046|U|substance (serotonin) that causes narrowing of blood vessels in||
1100|047|U|the brain. It may also relieve pain by affecting certain nerves||
1100|048|U|in the brain.||
1100|049|U|   This medication does not prevent future migraines or lessen||
1100|050|U|how often you get migraine attacks.||
1100|051|B|||
1100|052|H|HOW TO USE:  Read the Medication Guide provided by your||
1100|053|H|pharmacist before you start using this product and each time you||
1100|054|H|get a refill. If you have any questions, ask your doctor or||
1100|055|H|pharmacist.||
1100|056|H|   Take this medication by mouth at the first sign of a migraine||
1100|057|H|as directed by your doctor, with a full glass of water (8||
1100|058|H|ounces/240 milliliters). Do not lie down for at least 10 minutes||
1100|059|H|after taking this drug. To prevent stomach upset, take this||
1100|060|H|medication with food, milk, or an antacid. Do not break, crush,||
1100|061|H|or chew the tablet.||
1100|062|H|   The dosage is based on your medical condition, age, and||
1100|063|H|response to treatment. If there is no improvement in your||
1100|064|H|symptoms, do not take more doses of this medication before||
1100|065|H|talking to your doctor. If your symptoms are only partly||
1100|066|H|relieved, or if your headache comes back, you may take another||
1100|067|H|dose at least two hours after the first dose. Do not take more||
1100|068|H|than 2 doses in a 24-hour period.||
1100|069|H|   If you have a higher risk for heart problems (see||
1100|070|H|Precautions), your doctor may perform a heart exam before you||
1100|071|H|start taking this medication. He/she may also direct you to take||
1100|072|H|your first dose of this medication in the office/clinic to||
1100|073|H|monitor for serious side effects (such as chest pain). Talk to||
1100|074|H|your doctor for details.||
1100|075|H|   If you are using drugs for migraine attacks on 10 or more days||
1100|076|H|each month, the drugs may actually make your headaches worse||
1100|077|H|(medication overuse headache). Do not use medications more often||
1100|078|H|or for longer than directed. Tell your doctor if you need to use||
1100|079|H|this medication more often, or if the medication is not working||
1100|080|H|as well, or if your headaches get worse.||
1100|081|B|||
1100|082|S|SIDE EFFECTS:  See also Warning section.||
1100|083|S|   Flushing, feelings of tingling/numbness/prickling/heat,||
1100|084|S|nausea, upset stomach, tiredness, weakness, drowsiness, or||
1100|085|S|dizziness may occur. If any of these effects last or get worse,||
1100|086|S|tell your doctor or pharmacist promptly.||
1100|087|S|   Remember that this medication has been prescribed because your||
1100|088|S|doctor has judged that the benefit to you is greater than the||
1100|089|S|risk of side effects. Many people using this medication do not||
1100|090|S|have serious side effects.||
1100|091|S|   This medication may raise your blood pressure. Check your||
1100|092|S|blood pressure regularly and tell your doctor if the results are||
1100|093|S|high.||
1100|094|S|   Tell your doctor right away if you have any serious side||
1100|095|S|effects, including: blue fingers/toes/nails, cold hands/feet,||
1100|096|S|difficult/painful swallowing, easy bleeding/bruising, hearing||
1100|097|S|changes (such as ringing in the ears), mental/mood changes, signs||
1100|098|S|of kidney problems (such as change in the amount of urine),||
1100|099|S|symptoms of heart failure (such as swelling ankles/feet, unusual||
1100|100|S|tiredness, unusual/sudden weight gain).||
1100|101|S|   Sumatriptan can commonly cause chest/jaw/neck tightness, pain,||
1100|102|S|or pressure that is usually not serious. However, these side||
1100|103|S|effects are like symptoms of a heart attack, which may include||
1100|104|S|chest/jaw/left arm pain, shortness of breath, or unusual||
1100|105|S|sweating. Get medical help right away if these or other serious||
1100|106|S|side effects occur, including: fast/irregular heartbeat,||
1100|107|S|fainting, severe stomach/abdominal pain, bloody diarrhea,||
1100|108|S|seizure, signs of a stroke (such as weakness on one side of the||
1100|109|S|body, trouble speaking, sudden vision changes, confusion).||
1100|110|S|   This drug may rarely cause serious (possibly fatal) liver||
1100|111|S|disease. Get medical help right away if you have any symptoms of||
1100|112|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1100|113|S|of appetite, dark urine, yellowing eyes/skin.||
1100|114|S|   This medication may increase serotonin and rarely cause a very||
1100|115|S|serious condition called serotonin syndrome/toxicity. The risk||
1100|116|S|increases if you are also taking other drugs that increase||
1100|117|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1100|118|S|take (see Drug Interactions section). Get medical help right away||
1100|119|S|if you develop some of the following symptoms: fast heartbeat,||
1100|120|S|hallucinations, loss of coordination, severe dizziness, severe||
1100|121|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1100|122|S|unusual agitation/restlessness.||
1100|123|S|   A very serious allergic reaction to this drug is rare.||
1100|124|S|However, get medical help right away if you notice any symptoms||
1100|125|S|of a serious allergic reaction, including: fever, swollen lymph||
1100|126|S|nodes, rash, itching/swelling (especially of the||
1100|127|S|face/tongue/throat), severe dizziness, trouble breathing.||
1100|128|S|   This is not a complete list of possible side effects. If you||
1100|129|S|notice other effects not listed above, contact your doctor or||
1100|130|S|pharmacist.||
1100|131|S|   In the US -||
1100|132|S|   Call your doctor for medical advice about side effects. You||
1100|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1100|134|S|www.fda.gov/medwatch.||
1100|135|S|   In Canada - Call your doctor for medical advice about side||
1100|136|S|effects. You may report side effects to Health Canada at||
1100|137|S|1-866-234-2345.||
1100|138|B|||
1100|139|P|PRECAUTIONS:  See also Warning section.||
1100|140|P|   Before taking this product, tell your doctor or pharmacist if||
1100|141|P|you are allergic to naproxen or to sumatriptan; or to aspirin or||
1100|142|P|other NSAIDs (such as ibuprofen, celecoxib); or if you have any||
1100|143|P|other allergies. This product may contain inactive ingredients,||
1100|144|P|which can cause allergic reactions or other problems. Talk to||
1100|145|P|your pharmacist for more details.||
1100|146|P|   Before taking this medication, tell your doctor or pharmacist||
1100|147|P|your medical history, especially of: asthma (including a history||
1100|148|P|of worsening breathing after taking aspirin or other NSAIDs),||
1100|149|P|blood circulation problems (for example, in your legs,||
1100|150|P|arms/hands, or stomach), blood disorders (such as anemia,||
1100|151|P|bleeding/clotting problems), growths in the nose (nasal polyps),||
1100|152|P|certain types of headaches (hemiplegic or basilar migraine),||
1100|153|P|heart problems (such as chest pain, irregular heartbeat, previous||
1100|154|P|heart attack), liver disease, seizure, stroke or "mini-stroke"||
1100|155|P|(transient ischemic attack), throat/stomach/intestinal problems||
1100|156|P|(such as bleeding, heartburn, ulcers), swelling (edema, fluid||
1100|157|P|retention).||
1100|158|P|   Certain conditions can increase your risk for heart problems.||
1100|159|P|Tell your doctor if you have any of these conditions, including:||
1100|160|P|high blood pressure, high cholesterol, diabetes, family history||
1100|161|P|of heart disease, overweight, smoker, postmenopausal (women), age||
1100|162|P|more than 40 years (men).||
1100|163|P|   Kidney problems can sometimes occur with the use of NSAID||
1100|164|P|medications, including naproxen. Problems are more likely to||
1100|165|P|occur if you are dehydrated, have heart failure or kidney||
1100|166|P|disease, are an older adult, or if you take certain medications||
1100|167|P|(see also Drug Interactions section). Drink plenty of fluids as||
1100|168|P|directed by your doctor to prevent dehydration and tell your||
1100|169|P|doctor right away if you have a change in the amount of urine.||
1100|170|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1100|171|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1100|172|P|machinery, or do anything that needs alertness until you can do||
1100|173|P|it safely. Talk to your doctor if you are using marijuana||
1100|174|P|(cannabis).||
1100|175|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1100|176|P|and tobacco, especially when combined with this medicine, may||
1100|177|P|increase your risk for stomach bleeding. Limit alcohol and stop||
1100|178|P|smoking. Consult your doctor or pharmacist for more information.||
1100|179|P|   This product contains salt (sodium). Before using this drug,||
1100|180|P|tell your doctor if you are limiting the amount of salt in your||
1100|181|P|diet.||
1100|182|P|   Before having surgery, tell your doctor or dentist about all||
1100|183|P|the products you use (including prescription drugs,||
1100|184|P|nonprescription drugs, and herbal products).||
1100|185|P|   This medication may make you more sensitive to the sun. Limit||
1100|186|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1100|187|P|sunscreen and wear protective clothing when outdoors. Tell your||
1100|188|P|doctor right away if you get sunburned or have skin||
1100|189|P|blisters/redness.||
1100|190|P|   Older adults may be at greater risk for stomach/intestinal||
1100|191|P|bleeding, increased blood pressure, kidney problems, heart||
1100|192|P|attack, and stroke while using this drug.||
1100|193|P|   Before using this medication, women of childbearing age should||
1100|194|P|talk with their doctor(s) about the benefits and risks. Tell your||
1100|195|P|doctor if you are pregnant or if you plan to become pregnant.||
1100|196|P|This medication may harm an unborn baby and cause problems with||
1100|197|P|normal labor/delivery. It is not recommended for use in pregnancy||
1100|198|P|from 20 weeks until delivery. If your doctor decides that you||
1100|199|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1100|200|P|you should use the lowest effective dose for the shortest||
1100|201|P|possible time. You should not use this medication after 30 weeks||
1100|202|P|of pregnancy.||
1100|203|P|   These drugs pass into breast milk and may have undesirable||
1100|204|P|effects on a nursing infant. Consult your doctor before||
1100|205|P|breastfeeding.||
1100|206|B|||
1100|207|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1100|208|I|medications work or increase your risk for serious side effects.||
1100|209|I|This document does not contain all possible drug interactions.||
1100|210|I|Keep a list of all the products you use (including||
1100|211|I|prescription/nonprescription drugs and herbal products) and share||
1100|212|I|it with your doctor and pharmacist. Do not start, stop, or change||
1100|213|I|the dosage of any medicines without your doctor's approval.||
1100|214|I|   Some products that may interact with this drug include:||
1100|215|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1100|216|I|angiotensin II receptor blockers (such as losartan, valsartan),||
1100|217|I|cidofovir, corticosteroids (such as prednisone), "water pills"||
1100|218|I|(diuretics such as furosemide).||
1100|219|I|   Taking MAO inhibitors with this medication may cause a serious||
1100|220|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
1100|221|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1100|222|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1100|223|I|selegiline, tranylcypromine) during treatment with this||
1100|224|I|medication. Most MAO inhibitors should also not be taken for two||
1100|225|I|weeks before treatment with this medication. Ask your doctor when||
1100|226|I|to start or stop taking this medication.||
1100|227|I|   The risk of serotonin syndrome/toxicity increases if you are||
1100|228|I|also taking other drugs that increase serotonin. Examples include||
1100|229|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1100|230|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1100|231|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1100|232|I|serotonin syndrome/toxicity may be more likely when you start or||
1100|233|I|increase the dose of these drugs.||
1100|234|I|   This medication may increase the risk of bleeding when taken||
1100|235|I|with other drugs that also may cause bleeding. Examples include||
1100|236|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1100|237|I|dabigatran/enoxaparin/warfarin, among others.||
1100|238|I|   Check all prescription and nonprescription medicine labels||
1100|239|I|carefully since many medications contain pain relievers/fever||
1100|240|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
1100|241|I|ketorolac). These drugs are similar to naproxen and may increase||
1100|242|I|your risk of side effects if taken together. However, if your||
1100|243|I|doctor has told you to take low-dose aspirin to prevent heart||
1100|244|I|attack or stroke (usually 81-162 milligrams a day), you should||
1100|245|I|keep taking the aspirin unless your doctor tells you not to.||
1100|246|I|Daily use of naproxen may decrease aspirin's ability to prevent||
1100|247|I|heart attack/stroke. Talk with your doctor about the risks and||
1100|248|I|benefits. Ask about other medications that can be used to treat||
1100|249|I|pain/fever.||
1100|250|I|   If you also take any ergotamine medication (such as||
1100|251|I|dihydroergotamine) or other "triptan" drugs (such as||
1100|252|I|zolmitriptan, rizatriptan), you will need to separate your dose||
1100|253|I|of this medication from your dose of these other medications to||
1100|254|I|lessen the chance of serious side effects. Ask your doctor how||
1100|255|I|long you should wait between your doses of these drugs.||
1100|256|I|   This medication may interfere with certain lab tests (such as||
1100|257|I|bleeding times, adrenal function tests), possibly causing false||
1100|258|I|test results. Make sure lab personnel and all your doctors know||
1100|259|I|you use this drug.||
1100|260|B|||
1100|261|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1100|262|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1100|263|O|poison control center right away. US residents can call||
1100|264|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1100|265|O|Symptoms of overdose may include: severe stomach pain, extreme||
1100|266|O|drowsiness, seizures.||
1100|267|B|||
1100|268|N|NOTES:  Do not share this medication with others.||
1100|269|N|   Certain foods, beverages, or food additives (such as red wine,||
1100|270|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
1100|271|N|patterns such as irregular eating/sleeping habits or stress may||
1100|272|N|bring on a migraine headache. Avoiding these "triggers" may help||
1100|273|N|lessen migraine attacks. Consult your doctor for more details.||
1100|274|N|   Lab and/or medical tests (such as blood pressure, complete||
1100|275|N|blood count, kidney/liver function) may be done while you are||
1100|276|N|taking this medication. Keep all medical and lab appointments.||
1100|277|N|Consult your doctor for more details.||
1100|278|B|||
1100|279|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
1100|280|B|||
1100|281|R|STORAGE:  Store in the original container at room temperature||
1100|282|R|away from light and moisture. Do not store in the bathroom. Keep||
1100|283|R|the drying agent (desiccant) in the bottle. Tightly close the||
1100|284|R|bottle when not in use. Keep all medications away from children||
1100|285|R|and pets.||
1100|286|R|   Do not flush medications down the toilet or pour them into a||
1100|287|R|drain unless instructed to do so. Properly discard this product||
1100|288|R|when it is expired or no longer needed. Consult your pharmacist||
1100|289|R|or local waste disposal company.||
1100|290|B|||
1100|291|A|Information last revised July 2024.||
1100|292|A|Copyright(c) 2025 First Databank, Inc.||
1100|293|B|||
1101|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1101|002|Z|does NOT have all possible information about this product. This||
1101|003|Z|information does not assure that this product is safe, effective,||
1101|004|Z|or appropriate for you. This information is not individual||
1101|005|Z|medical advice and does not substitute for the advice of your||
1101|006|Z|health care professional. Always ask your health care||
1101|007|Z|professional for complete information about this product and your||
1101|008|Z|specific health needs.||
1101|009|B|||
1101|010|T|OLOPATADINE SPRAY - NASAL||
1101|011|F|(oh-low-PAT-uh-deen)||
1101|012|B|||
1101|013|C|COMMON BRAND NAME(S): Patanase||
1101|014|B|||
1101|015|U|USES:  Olopatadine is used to relieve symptoms of seasonal||
1101|016|U|allergies that occur in the nose, such as runny/itchy/stuffy||
1101|017|U|nose, sneezing, and post-nasal drip. This medication is an||
1101|018|U|antihistamine. It works by blocking certain natural substances||
1101|019|U|called histamines that are responsible for allergic symptoms.||
1101|020|U|   Do not use this medication in children younger than 2 years||
1101|021|U|unless specifically directed by the doctor. To decrease the risk||
1101|022|U|for serious side effects, carefully follow all of the doctor's||
1101|023|U|dosage directions. Do not give other cough and cold medication||
1101|024|U|that might contain the same or similar ingredients (see also Drug||
1101|025|U|Interactions section). Ask your doctor or pharmacist about other||
1101|026|U|ways to relieve cough and cold symptoms (such as saline nose||
1101|027|U|drops/spray, using a humidifier or infant nasal suction bulb).||
1101|028|B|||
1101|029|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1101|030|H|your pharmacist before you start using olopatadine and each time||
1101|031|H|you get a refill. Follow the instructions on how to properly use||
1101|032|H|this medication. If you have any questions, ask your doctor or||
1101|033|H|pharmacist.||
1101|034|H|   Follow the instructions for properly priming the spray pump||
1101|035|H|before using the bottle for the first time and if you have not||
1101|036|H|used the medication for more than 7 days. Avoid spraying in your||
1101|037|H|eyes or directly onto the nasal septum (the wall between the two||
1101|038|H|nostrils).||
1101|039|H|   Use this medication in your nose as directed by your doctor,||
1101|040|H|usually twice a day in both nostrils.||
1101|041|H|   Use this medication regularly to get the most benefit from it.||
1101|042|H|To help you remember, use it at the same times each day.||
1101|043|H|   Keep track of the number of sprays you use, including test||
1101|044|H|sprays used to prime the bottle. Discard the bottle after you||
1101|045|H|have used the labeled number of sprays on the product package,||
1101|046|H|even if the bottle is not completely empty. By doing this, you||
1101|047|H|can be sure that you get the correct amount of drug in each||
1101|048|H|spray.||
1101|049|H|   Tell your doctor if your symptoms do not get better.||
1101|050|B|||
1101|051|S|SIDE EFFECTS:  A bitter taste in the mouth, nosebleeds, or||
1101|052|S|irritation/soreness in the nose may occur. Drowsiness may rarely||
1101|053|S|occur. If any of these effects last or get worse, tell your||
1101|054|S|doctor or pharmacist promptly.||
1101|055|S|   The bitter taste can be reduced by sniffing gently through||
1101|056|S|your nose after each spray, rather than breathing in through your||
1101|057|S|nose so deeply that the medication goes to the back of your||
1101|058|S|throat and gets into your mouth.||
1101|059|S|   Remember that this medication has been prescribed because your||
1101|060|S|doctor has judged that the benefit to you is greater than the||
1101|061|S|risk of side effects. Many people using this medication do not||
1101|062|S|have serious side effects.||
1101|063|S|   Tell your doctor right away if you have any serious side||
1101|064|S|effects, including: sores in your nose, hole in the nasal septum.||
1101|065|S|   A very serious allergic reaction to this drug is rare.||
1101|066|S|However, get medical help right away if you notice any symptoms||
1101|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1101|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1101|069|S|breathing.||
1101|070|S|   This is not a complete list of possible side effects. If you||
1101|071|S|notice other effects not listed above, contact your doctor or||
1101|072|S|pharmacist.||
1101|073|S|   In the US -||
1101|074|S|   Call your doctor for medical advice about side effects. You||
1101|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1101|076|S|www.fda.gov/medwatch.||
1101|077|S|   In Canada - Call your doctor for medical advice about side||
1101|078|S|effects. You may report side effects to Health Canada at||
1101|079|S|1-866-234-2345.||
1101|080|B|||
1101|081|P|PRECAUTIONS:  Before using olopatadine, tell your doctor or||
1101|082|P|pharmacist if you are allergic to it; or if you have any other||
1101|083|P|allergies. This product may contain inactive ingredients, which||
1101|084|P|can cause allergic reactions or other problems. Talk to your||
1101|085|P|pharmacist for more details.||
1101|086|P|   Before using this medication, tell your doctor or pharmacist||
1101|087|P|your medical history.||
1101|088|P|   This drug may rarely make you drowsy. Alcohol or marijuana||
1101|089|P|(cannabis) can make you more drowsy. Do not drive, use machinery,||
1101|090|P|or do anything that needs alertness until you can do it safely.||
1101|091|P|Limit alcoholic beverages. Talk to your doctor if you are using||
1101|092|P|marijuana (cannabis).||
1101|093|P|   During pregnancy, this medication should be used only when||
1101|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
1101|095|P|   It is unknown if this drug passes into breast milk. Consult||
1101|096|P|your doctor before breastfeeding.||
1101|097|B|||
1101|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1101|099|I|medications work or increase your risk for serious side effects.||
1101|100|I|This document does not contain all possible drug interactions.||
1101|101|I|Keep a list of all the products you use (including||
1101|102|I|prescription/nonprescription drugs and herbal products) and share||
1101|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
1101|104|I|the dosage of any medicines without your doctor's approval.||
1101|105|I|   Tell your doctor or pharmacist if you are taking other||
1101|106|I|products that cause drowsiness such as opioid pain or cough||
1101|107|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1101|108|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1101|109|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1101|110|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1101|111|I|diphenhydramine).||
1101|112|I|   Check the labels on all your medicines (such as allergy or||
1101|113|I|cough-and-cold products) because they may contain ingredients||
1101|114|I|that cause drowsiness. Ask your pharmacist about using those||
1101|115|I|products safely.||
1101|116|B|||
1101|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1101|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1101|119|O|poison control center right away. US residents can call||
1101|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1101|121|O|Symptoms of overdose in adults may include drowsiness. In||
1101|122|O|children, overdose symptoms may include restlessness/agitation,||
1101|123|O|and may be followed by drowsiness.||
1101|124|B|||
1101|125|N|NOTES:  Do not share this medication with others.||
1101|126|B|||
1101|127|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1101|128|D|If it is near the time of the next dose, skip the missed dose.||
1101|129|D|Use your next dose at the regular time. Do not double the dose to||
1101|130|D|catch up.||
1101|131|B|||
1101|132|R|STORAGE:  Store at room temperature. Keep all medications away||
1101|133|R|from children and pets.||
1101|134|R|   Do not flush medications down the toilet or pour them into a||
1101|135|R|drain unless instructed to do so. Properly discard this product||
1101|136|R|when it is expired or no longer needed. Consult your pharmacist||
1101|137|R|or local waste disposal company.||
1101|138|B|||
1101|139|A|Information last revised November 2024.||
1101|140|A|Copyright(c) 2025 First Databank, Inc.||
1101|141|B|||
1102|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1102|002|Z|does NOT have all possible information about this product. This||
1102|003|Z|information does not assure that this product is safe, effective,||
1102|004|Z|or appropriate for you. This information is not individual||
1102|005|Z|medical advice and does not substitute for the advice of your||
1102|006|Z|health care professional. Always ask your health care||
1102|007|Z|professional for complete information about this product and your||
1102|008|Z|specific health needs.||
1102|009|B|||
1102|010|T|RISEDRONATE 150 MG - ORAL||
1102|011|F|(riss-ED-row-nate)||
1102|012|B|||
1102|013|C|COMMON BRAND NAME(S): Actonel||
1102|014|B|||
1102|015|U|USES:  Risedronate is used to prevent and treat certain types of||
1102|016|U|bone loss (osteoporosis) in adults. Osteoporosis causes bones to||
1102|017|U|become thinner and break more easily. Your chance of developing||
1102|018|U|osteoporosis increases as you age, after menopause, or if you||
1102|019|U|take corticosteroid medications (such as prednisone) for a long||
1102|020|U|time.||
1102|021|U|   This medication works by slowing bone loss to help maintain||
1102|022|U|strong bones and reduces the risk of broken bones (fractures).||
1102|023|U|Risedronate belongs to a class of medications called||
1102|024|U|bisphosphonates.||
1102|025|B|||
1102|026|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1102|027|H|Patient Information Leaflet provided by your pharmacist before||
1102|028|H|you start using risedronate and each time you get a refill.||
1102|029|H|Follow the instructions very closely to make sure you absorb as||
1102|030|H|much of the drug as possible and reduce the risk of injury to||
1102|031|H|your esophagus. If you have any questions, ask your doctor or||
1102|032|H|pharmacist.||
1102|033|H|   Take this medication by mouth as directed by your doctor,||
1102|034|H|usually once a month. Take it after getting up for the day and||
1102|035|H|before taking your first food, beverage, or other medication. Do||
1102|036|H|not take it at bedtime or while you are still in bed.||
1102|037|H|   Take this medication with a full glass of plain water (6 to 8||
1102|038|H|ounces or 180 to 240 milliliters). Do not take it with any other||
1102|039|H|beverage. Swallow the tablet whole. Do not chew or suck on it.||
1102|040|H|Then stay fully upright (sitting, standing, or walking) for at||
1102|041|H|least 30 minutes, and do not lie down until after your first food||
1102|042|H|of the day. Wait at least 30 minutes after taking risedronate||
1102|043|H|before you eat or drink anything other than plain water and||
1102|044|H|before taking any other medication by mouth.||
1102|045|H|   Calcium or iron supplements, vitamins with minerals, antacids||
1102|046|H|containing calcium/magnesium/aluminum, dairy products (such as||
1102|047|H|milk, yogurt), and juice with added calcium may interfere with||
1102|048|H|absorption of risedronate. Medications such as quinapril,||
1102|049|H|sucralfate, and bismuth subsalicylate may also interfere with||
1102|050|H|absorption. Do not take these products for at least 30 minutes||
1102|051|H|after taking risedronate.||
1102|052|H|   Take this medication regularly to get the most benefit from||
1102|053|H|it. To help you remember, take it on the same day each month.||
1102|054|H|Mark your calendar with a reminder. Talk to your doctor about the||
1102|055|H|risks and benefits of long-term use of this medication.||
1102|056|B|||
1102|057|S|SIDE EFFECTS:  Upset stomach may occur. Although uncommon, mild||
1102|058|S|flu-like symptoms (such as fever, tiredness, muscle aches) may||
1102|059|S|occur within several days of taking your first monthly dose, but||
1102|060|S|usually last less than a week. If any of these effects last or||
1102|061|S|get worse, tell your doctor or pharmacist promptly.||
1102|062|S|   Remember that this medication has been prescribed because your||
1102|063|S|doctor has judged that the benefit to you is greater than the||
1102|064|S|risk of side effects. Many people using this medication do not||
1102|065|S|have serious side effects.||
1102|066|S|   Tell your doctor right away if you have any serious side||
1102|067|S|effects, including: increased or severe bone/joint/muscle pain,||
1102|068|S|new or unusual hip/thigh/groin pain, jaw pain, eye/vision||
1102|069|S|problems.||
1102|070|S|   This medication may rarely cause irritation and ulcers in your||
1102|071|S|stomach or esophagus. Get medical help right away if any of these||
1102|072|S|serious side effects occur: new/severe/worsening heartburn, chest||
1102|073|S|pain, difficult or painful swallowing, severe stomach/abdominal||
1102|074|S|pain, black/tarry stools, vomit that looks like coffee grounds.||
1102|075|S|   A very serious allergic reaction to this drug is rare.||
1102|076|S|However, get medical help right away if you notice any symptoms||
1102|077|S|of a serious allergic reaction, including: rash, itching/swelling||
1102|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1102|079|S|breathing.||
1102|080|S|   This is not a complete list of possible side effects. If you||
1102|081|S|notice other effects not listed above, contact your doctor or||
1102|082|S|pharmacist.||
1102|083|S|   In the US -||
1102|084|S|   Call your doctor for medical advice about side effects. You||
1102|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1102|086|S|www.fda.gov/medwatch.||
1102|087|S|   In Canada - Call your doctor for medical advice about side||
1102|088|S|effects. You may report side effects to Health Canada at||
1102|089|S|1-866-234-2345.||
1102|090|B|||
1102|091|P|PRECAUTIONS:  Before taking risedronate, tell your doctor or||
1102|092|P|pharmacist if you are allergic to it; or to other bisphosphonates||
1102|093|P|(such as alendronate); or if you have any other allergies. This||
1102|094|P|product may contain inactive ingredients, which can cause||
1102|095|P|allergic reactions or other problems. Talk to your pharmacist for||
1102|096|P|more details.||
1102|097|P|   Before using this medication, tell your doctor or pharmacist||
1102|098|P|your medical history, especially of: esophagus problems (such as||
1102|099|P|heartburn, narrowing of the esophagus, achalasia), difficult or||
1102|100|P|painful swallowing, low levels of calcium in the blood||
1102|101|P|(hypocalcemia), inability to sit upright or stand for at least 30||
1102|102|P|minutes, stomach/intestinal disorders (such as ulcers), severe||
1102|103|P|kidney disease.||
1102|104|P|   Some people taking risedronate may have serious jawbone||
1102|105|P|problems. Your doctor should check your mouth before you start||
1102|106|P|this medication. Tell your dentist that you are taking this||
1102|107|P|medication before you have any dental work done. To help prevent||
1102|108|P|jawbone problems, have regular dental exams and learn how to keep||
1102|109|P|your teeth and gums healthy. If you have jaw pain, tell your||
1102|110|P|doctor and dentist right away.||
1102|111|P|   Before having any surgery (especially dental procedures), tell||
1102|112|P|your doctor and dentist about this medication and all other||
1102|113|P|products you use (including prescription drugs, nonprescription||
1102|114|P|drugs, and herbal products). Your doctor or dentist may tell you||
1102|115|P|to stop taking risedronate before your surgery. Ask for specific||
1102|116|P|instructions about stopping or starting this medication.||
1102|117|P|   Tell your doctor if you are pregnant or plan to become||
1102|118|P|pregnant. Risedronate may stay in your body for many years. You||
1102|119|P|should not become pregnant while using risedronate. Discuss the||
1102|120|P|risks and benefits with your doctor.||
1102|121|P|   It is unknown if this drug passes into breast milk. Consult||
1102|122|P|your doctor before breastfeeding.||
1102|123|B|||
1102|124|I|DRUG INTERACTIONS:  See also How to Use section.||
1102|125|I|   Drug interactions may change how your medications work or||
1102|126|I|increase your risk for serious side effects. This document does||
1102|127|I|not contain all possible drug interactions. Keep a list of all||
1102|128|I|the products you use (including prescription/nonprescription||
1102|129|I|drugs and herbal products) and share it with your doctor and||
1102|130|I|pharmacist. Do not start, stop, or change the dosage of any||
1102|131|I|medicines without your doctor's approval.||
1102|132|I|   This medication may interfere with certain lab tests (such as||
1102|133|I|bone-imaging tests), possibly causing false test results. Make||
1102|134|I|sure lab personnel and all your doctors know you use this drug.||
1102|135|B|||
1102|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1102|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1102|138|O|poison control center right away. US residents can call||
1102|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1102|140|B|||
1102|141|N|NOTES:  Do not share this medication with others.||
1102|142|N|   Lifestyle changes that help promote healthy bones include||
1102|143|N|increasing weight-bearing exercise, stopping smoking, limiting||
1102|144|N|alcohol, and eating well-balanced meals that contain adequate||
1102|145|N|calcium and vitamin D. Since you may also need to take calcium||
1102|146|N|and vitamin D supplements and make lifestyle changes, consult||
1102|147|N|your doctor for specific advice.||
1102|148|N|   Lab and/or medical tests (x-rays, height, blood mineral||
1102|149|N|levels) should be done while you are taking this medication. Keep||
1102|150|N|all medical and lab appointments. Consult your doctor for more||
1102|151|N|details.||
1102|152|B|||
1102|153|D|MISSED DOSE:  If you miss your dose when you first get up for the||
1102|154|D|day, do not take it later in the day. If you miss a dose and next||
1102|155|D|month's scheduled dose is more than 7 days away, take the missed||
1102|156|D|dose the next day when you first get up. Then take your next dose||
1102|157|D|at the regular time. Do not take more than 1 dose within 7 days.||
1102|158|D|   If you miss a dose and next month's scheduled dose is less||
1102|159|D|than 7 days away, skip the missed dose. Take your next dose at||
1102|160|D|the regular time. Do not double the dose to catch up.||
1102|161|D|   If you have any questions, ask your doctor or pharmacist.||
1102|162|B|||
1102|163|R|STORAGE:  Store at room temperature away from light and moisture.||
1102|164|R|Do not store in the bathroom. Keep all medications away from||
1102|165|R|children and pets.||
1102|166|R|   Do not flush medications down the toilet or pour them into a||
1102|167|R|drain unless instructed to do so. Properly discard this product||
1102|168|R|when it is expired or no longer needed. Consult your pharmacist||
1102|169|R|or local waste disposal company.||
1102|170|B|||
1102|171|A|Information last revised September 2025.||
1102|172|A|Copyright(c) 2025 First Databank, Inc.||
1102|173|B|||
1103|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1103|002|Z|does NOT have all possible information about this product. This||
1103|003|Z|information does not assure that this product is safe, effective,||
1103|004|Z|or appropriate for you. This information is not individual||
1103|005|Z|medical advice and does not substitute for the advice of your||
1103|006|Z|health care professional. Always ask your health care||
1103|007|Z|professional for complete information about this product and your||
1103|008|Z|specific health needs.||
1103|009|B|||
1103|010|T|CERTOLIZUMAB - INJECTION||
1103|011|F|(SER-toe-LIZ-oo-mab)||
1103|012|B|||
1103|013|C|COMMON BRAND NAME(S): Cimzia||
1103|014|B|||
1103|015|W|WARNING:  This medication can decrease your body's ability to||
1103|016|W|fight an infection. This effect can lead to very serious||
1103|017|W|(possibly fatal) infections (such as fungal infections, bacterial||
1103|018|W|infections including tuberculosis). You should have a||
1103|019|W|tuberculosis (TB) skin test before and during treatment with this||
1103|020|W|medication. Also tell your doctor your medical history,||
1103|021|W|especially of past/recent/current infections. You should also||
1103|022|W|tell your doctor if you have lived or traveled in areas where||
1103|023|W|certain fungal infections (such as coccidioidomycosis,||
1103|024|W|histoplasmosis) are common or if you have been near someone with||
1103|025|W|tuberculosis. Tell your doctor right away if you develop signs of||
1103|026|W|an infection while using this drug, such as sore throat or cough||
1103|027|W|that doesn't go away, fever, chills, night sweats,||
1103|028|W|painful/frequent urination, unusual vaginal discharge, white||
1103|029|W|patches in the mouth (oral thrush).||
1103|030|W|   If you are diagnosed with TB, you must first be treated for it||
1103|031|W|before you start certolizumab to prevent a serious TB infection.||
1103|032|W|   Though it is very unlikely to happen, there is a risk||
1103|033|W|(especially in children/teens/young adults) of developing cancer||
1103|034|W|(such as lymphoma, skin) due to this medication or due to your||
1103|035|W|medical condition. Discuss the risks and benefits of treatment||
1103|036|W|with your doctor. Tell your doctor right away if you develop||
1103|037|W|symptoms such as fever that doesn't go away, unusual||
1103|038|W|lumps/growths, skin changes, swollen lymph nodes, swollen or||
1103|039|W|painful abdomen, unexplained weight loss, or night sweats.||
1103|040|B|||
1103|041|U|USES:  This medication is used to reduce pain and swelling due to||
1103|042|U|certain inflammatory conditions (such as rheumatoid arthritis,||
1103|043|U|psoriatic arthritis, ankylosing spondylitis, plaque psoriasis,||
1103|044|U|polyarticular juvenile idiopathic arthritis). Some brands may||
1103|045|U|also be used to treat a certain type of spine condition (axial||
1103|046|U|spondyloarthritis) or a certain bowel condition (Crohn's||
1103|047|U|disease). Certolizumab belongs to a class of drugs known as tumor||
1103|048|U|necrosis factor (TNF) blockers. It works by blocking TNF, a||
1103|049|U|substance made by the body that causes inflammation.||
1103|050|B|||
1103|051|H|HOW TO USE:  Read the Medication Guide and the Instructions for||
1103|052|H|Use provided by your pharmacist before you start using||
1103|053|H|certolizumab and each time you get a refill. If you have any||
1103|054|H|questions, consult your doctor or pharmacist.||
1103|055|H|   Inject this medication under the skin as directed by your||
1103|056|H|doctor. The injection is given in the stomach or thigh area. The||
1103|057|H|dosage is based on your medical condition and response to||
1103|058|H|treatment. Children's dosage is also based on weight.||
1103|059|H|   If you are giving this medication to yourself at home, learn||
1103|060|H|all preparation and usage instructions from your health care||
1103|061|H|professional. Take the medication out of the refrigerator 30||
1103|062|H|minutes before you inject it to allow it to reach room||
1103|063|H|temperature. Do not warm up this medication any other way (for||
1103|064|H|example, do not heat it in the microwave or place it in hot||
1103|065|H|water). Before using, check this product for particles or||
1103|066|H|discoloration. If either is present, do not use the liquid.||
1103|067|H|Before injecting each dose, clean the skin you are going to||
1103|068|H|inject into (the injection site) with rubbing alcohol. Change the||
1103|069|H|injection site each time to lessen injury under the skin. Do not||
1103|070|H|inject into skin that is sore, bruised, red, scaly, or hard. To||
1103|071|H|lessen bruising, do not rub the injection site after a shot.||
1103|072|H|Learn how to store and discard medical supplies safely.||
1103|073|H|   Use this medication regularly to get the most benefit from it.||
1103|074|H|To help you remember, mark your calendar with a reminder.||
1103|075|H|   Tell your doctor if your condition does not get better or if||
1103|076|H|it gets worse.||
1103|077|B|||
1103|078|S|SIDE EFFECTS:  See also Warning section.||
1103|079|S|   Cough, sore throat, stuffy/runny nose, or joint pain may||
1103|080|S|occur. If any of these effects last or get worse, tell your||
1103|081|S|doctor or pharmacist promptly.||
1103|082|S|   Remember that this medication has been prescribed because your||
1103|083|S|doctor has judged that the benefit to you is greater than the||
1103|084|S|risk of side effects. Many people using this medication do not||
1103|085|S|have serious side effects.||
1103|086|S|   Tell your doctor right away if you have any serious side||
1103|087|S|effects, including: easy bruising/bleeding, swollen joints, rash||
1103|088|S|on nose and cheeks, eye pain, vision changes, dizziness,||
1103|089|S|numbness/tingling of arms/legs, seizures, new or worsening||
1103|090|S|symptoms of heart failure (such as shortness of breath, swelling||
1103|091|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
1103|092|S|   Certolizumab may rarely cause serious (possibly fatal) liver||
1103|093|S|disease in people exposed to hepatitis B virus. Your doctor may||
1103|094|S|order blood tests and watch for symptoms during treatment and for||
1103|095|S|several months after your last treatment. Get medical help right||
1103|096|S|away if you have any symptoms of liver damage, including:||
1103|097|S|nausea/vomiting that doesn't stop, stomach/abdominal pain, dark||
1103|098|S|urine, yellowing eyes/skin.||
1103|099|S|   A very serious allergic reaction to this drug is rare.||
1103|100|S|However, get medical help right away if you notice any symptoms||
1103|101|S|of a serious allergic reaction, including: rash, itching/swelling||
1103|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1103|103|S|breathing.||
1103|104|S|   This is not a complete list of possible side effects. If you||
1103|105|S|notice other effects not listed above, contact your doctor or||
1103|106|S|pharmacist.||
1103|107|S|   In the US -||
1103|108|S|   Call your doctor for medical advice about side effects. You||
1103|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1103|110|S|www.fda.gov/medwatch.||
1103|111|S|   In Canada - Call your doctor for medical advice about side||
1103|112|S|effects. You may report side effects to Health Canada at||
1103|113|S|1-866-234-2345.||
1103|114|B|||
1103|115|P|PRECAUTIONS:  Before using certolizumab, tell your doctor or||
1103|116|P|pharmacist if you are allergic to it; or if you have any other||
1103|117|P|allergies. This product may contain inactive ingredients (such as||
1103|118|P|latex found in the rubber syringe cap of some brands), which can||
1103|119|P|cause allergic reactions or other problems. Talk to your||
1103|120|P|pharmacist for more details.||
1103|121|P|   Before using this medication, tell your doctor or pharmacist||
1103|122|P|your medical history, especially of: any current/recent infection||
1103|123|P|(such as HIV, hepatitis B, tuberculosis), any infection that||
1103|124|P|keeps coming back, cuts or open sores, cancer, diabetes, heart||
1103|125|P|failure, blood/bone marrow disorders, history of cancer (such as||
1103|126|P|lymphoma), brain/nervous system disorders (such as multiple||
1103|127|P|sclerosis, seizures).||
1103|128|P|   Certolizumab can make you more likely to get infections or may||
1103|129|P|make current infections worse. Stay away from anyone who has an||
1103|130|P|infection that may easily spread (such as chickenpox, COVID-19,||
1103|131|P|measles, flu). Talk to your doctor if you have been exposed to an||
1103|132|P|infection or for more details.||
1103|133|P|   Tell your health care professional that you are using||
1103|134|P|certolizumab before having any immunizations/vaccinations. Avoid||
1103|135|P|contact with people who have recently received live vaccines||
1103|136|P|(such as flu vaccine inhaled through the nose).||
1103|137|P|   To lower the chance of getting cut, bruised, or injured, use||
1103|138|P|caution with sharp objects like razors and nail cutters, and||
1103|139|P|avoid activities such as contact sports.||
1103|140|P|   Before having surgery, tell your doctor or dentist about all||
1103|141|P|the products you use (including prescription drugs,||
1103|142|P|nonprescription drugs, and herbal products).||
1103|143|P|   Older adults are more sensitive to the effects of this drug,||
1103|144|P|especially the risk of infections.||
1103|145|P|   During pregnancy, this medication should be used only when||
1103|146|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1103|147|P|benefits with your doctor. Mothers who have used this medication||
1103|148|P|during pregnancy should ask a doctor about||
1103|149|P|immunizations/vaccinations for their newborn babies.||
1103|150|P|   This medication passes into breast milk Consult your doctor||
1103|151|P|before breastfeeding.||
1103|152|B|||
1103|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1103|154|I|medications work or increase your risk for serious side effects.||
1103|155|I|This document does not contain all possible drug interactions.||
1103|156|I|Keep a list of all the products you use (including||
1103|157|I|prescription/nonprescription drugs and herbal products) and share||
1103|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
1103|159|I|the dosage of any medicines without your doctor's approval.||
1103|160|I|   Some products that may interact with this drug include:||
1103|161|I|abatacept, anakinra, other drugs that weaken the immune system||
1103|162|I|(such as azathioprine, cancer chemotherapy, cyclosporine).||
1103|163|I|   This medication may interfere with certain lab tests (such as||
1103|164|I|aPTT tests), possibly causing false test results. Make sure lab||
1103|165|I|personnel and all your doctors know you use this drug.||
1103|166|B|||
1103|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1103|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1103|169|O|poison control center right away. US residents can call||
1103|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1103|171|B|||
1103|172|N|NOTES:  Do not share this medication with others.||
1103|173|N|   Lab and/or medical tests (such as complete blood count, liver||
1103|174|N|function, skin exams) may be done while you are using this||
1103|175|N|medication. Keep all medical and lab appointments. Consult your||
1103|176|N|doctor for more details.||
1103|177|B|||
1103|178|D|MISSED DOSE:  It is important to get each dose of this medication||
1103|179|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1103|180|D|right away for a new dosing schedule. Do not double the dose to||
1103|181|D|catch up.||
1103|182|B|||
1103|183|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1103|184|R|medication in the original package to protect from light. This||
1103|185|R|medication may also be stored at room temperature if needed. If||
1103|186|R|the medication is stored at room temperature, do not put it back||
1103|187|R|in the refrigerator and discard within the time directed in the||
1103|188|R|product instructions. Keep all medications away from children and||
1103|189|R|pets.||
1103|190|R|   Do not flush medications down the toilet or pour them into a||
1103|191|R|drain unless instructed to do so. Properly discard this product||
1103|192|R|when it is expired or no longer needed. Consult your pharmacist||
1103|193|R|or local waste disposal company.||
1103|194|B|||
1103|195|M|MEDICAL ALERT:  Your condition can cause complications in a||
1103|196|M|medical emergency. For information about enrolling in MedicAlert,||
1103|197|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1103|198|B|||
1103|199|A|Information last revised May 2025.||
1103|200|A|Copyright(c) 2025 First Databank, Inc.||
1103|201|B|||
1105|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1105|002|Z|does NOT have all possible information about this product. This||
1105|003|Z|information does not assure that this product is safe, effective,||
1105|004|Z|or appropriate for you. This information is not individual||
1105|005|Z|medical advice and does not substitute for the advice of your||
1105|006|Z|health care professional. Always ask your health care||
1105|007|Z|professional for complete information about this product and your||
1105|008|Z|specific health needs.||
1105|009|B|||
1105|010|T|METHOCARBAMOL - ORAL||
1105|011|F|(meth-oh-KAR-ba-mole)||
1105|012|B|||
1105|013|C|COMMON BRAND NAME(S): Robaxin||
1105|014|B|||
1105|015|U|USES:  Methocarbamol is used to treat muscle spasms/pain. It is||
1105|016|U|usually used along with rest, physical therapy, and other||
1105|017|U|treatment. It works by helping to relax the muscles.||
1105|018|B|||
1105|019|H|HOW TO USE:  Take this medication by mouth with or without food||
1105|020|H|as directed by your doctor. Do not increase your dose or use this||
1105|021|H|drug more often or for longer than prescribed. Your condition||
1105|022|H|will not improve any faster, and your risk of side effects will||
1105|023|H|increase.||
1105|024|H|   The dosage is based on your medical condition and response to||
1105|025|H|treatment.||
1105|026|H|   Tell your doctor if your condition does not get better or if||
1105|027|H|it gets worse.||
1105|028|B|||
1105|029|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, stomach||
1105|030|S|upset, nausea/vomiting, or blurred vision may occur. If any of||
1105|031|S|these effects last or get worse, tell your doctor or pharmacist||
1105|032|S|promptly.||
1105|033|S|   Remember that this medication has been prescribed because your||
1105|034|S|doctor has judged that the benefit to you is greater than the||
1105|035|S|risk of side effects. Many people using this medication do not||
1105|036|S|have serious side effects.||
1105|037|S|   Tell your doctor right away if you have any serious side||
1105|038|S|effects, including: nausea/vomiting that doesn't stop, fainting,||
1105|039|S|slow heartbeat, yellowing eyes/skin, mental/mood changes (such as||
1105|040|S|confusion, forgetfulness).||
1105|041|S|   A very serious allergic reaction to this drug is rare.||
1105|042|S|However, get medical help right away if you notice any symptoms||
1105|043|S|of a serious allergic reaction, including: rash, itching/swelling||
1105|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1105|045|S|breathing.||
1105|046|S|   This is not a complete list of possible side effects. If you||
1105|047|S|notice other effects not listed above, contact your doctor or||
1105|048|S|pharmacist.||
1105|049|S|   In the US -||
1105|050|S|   Call your doctor for medical advice about side effects. You||
1105|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1105|052|S|www.fda.gov/medwatch.||
1105|053|S|   In Canada - Call your doctor for medical advice about side||
1105|054|S|effects. You may report side effects to Health Canada at||
1105|055|S|1-866-234-2345.||
1105|056|B|||
1105|057|P|PRECAUTIONS:  Before taking methocarbamol, tell your doctor or||
1105|058|P|pharmacist if you are allergic to it; or if you have any other||
1105|059|P|allergies. This product may contain inactive ingredients, which||
1105|060|P|can cause allergic reactions or other problems. Talk to your||
1105|061|P|pharmacist for more details.||
1105|062|P|   Before using this medication, tell your doctor or pharmacist||
1105|063|P|your medical history, especially of: liver disease.||
1105|064|P|   This drug may make you dizzy or drowsy or blur your vision.||
1105|065|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1105|066|P|drowsy. Do not drive, use machinery, or do anything that needs||
1105|067|P|alertness or clear vision until you can do it safely. Avoid||
1105|068|P|alcoholic beverages. Talk to your doctor if you are using||
1105|069|P|marijuana (cannabis).||
1105|070|P|   Before having surgery, tell your doctor or dentist about all||
1105|071|P|the products you use (including prescription drugs,||
1105|072|P|nonprescription drugs, and herbal products).||
1105|073|P|   Older adults may be more sensitive to the side effects of this||
1105|074|P|drug, especially confusion, dizziness, or drowsiness. These side||
1105|075|P|effects can increase the risk of falling.||
1105|076|P|   During pregnancy, this medication should be used only when||
1105|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
1105|078|P|   It is unknown if this drug passes into breast milk. Consult||
1105|079|P|your doctor before breastfeeding.||
1105|080|B|||
1105|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1105|082|I|medications work or increase your risk for serious side effects.||
1105|083|I|This document does not contain all possible drug interactions.||
1105|084|I|Keep a list of all the products you use (including||
1105|085|I|prescription/nonprescription drugs and herbal products) and share||
1105|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
1105|087|I|the dosage of any medicines without your doctor's approval.||
1105|088|I|   Tell your doctor or pharmacist if you are taking other||
1105|089|I|products that cause drowsiness such as opioid pain or cough||
1105|090|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1105|091|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1105|092|I|lorazepam, zolpidem), other muscle relaxants (such as||
1105|093|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1105|094|I|cetirizine, diphenhydramine).||
1105|095|I|   Check the labels on all your medicines (such as allergy or||
1105|096|I|cough-and-cold products) because they may contain ingredients||
1105|097|I|that cause drowsiness. Ask your pharmacist about using those||
1105|098|I|products safely.||
1105|099|I|   This medication may interfere with certain lab tests (such as||
1105|100|I|VMA or 5-HIAA urine screening test), possibly causing false test||
1105|101|I|results. Make sure lab personnel and all your doctors know you||
1105|102|I|use this drug.||
1105|103|B|||
1105|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1105|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1105|106|O|poison control center right away. US residents can call||
1105|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1105|108|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
1105|109|O|seizures, loss of consciousness.||
1105|110|B|||
1105|111|N|NOTES:  Do not share this medication with others.||
1105|112|N|   This medication has been prescribed for your current condition||
1105|113|N|only. Do not use it later for another condition unless your||
1105|114|N|doctor directs you to do so. A different medication may be||
1105|115|N|necessary in that case.||
1105|116|B|||
1105|117|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1105|118|D|remember. If it is near the time of the next dose, skip the||
1105|119|D|missed dose. Take your next dose at the regular time. Do not||
1105|120|D|double the dose to catch up.||
1105|121|B|||
1105|122|R|STORAGE:  Store at room temperature away from light and moisture.||
1105|123|R|Do not store in the bathroom. Keep all medications away from||
1105|124|R|children and pets.||
1105|125|R|   Do not flush medications down the toilet or pour them into a||
1105|126|R|drain unless instructed to do so. Properly discard this product||
1105|127|R|when it is expired or no longer needed. Consult your pharmacist||
1105|128|R|or local waste disposal company.||
1105|129|B|||
1105|130|A|Information last revised October 2024.||
1105|131|A|Copyright(c) 2025 First Databank, Inc.||
1105|132|B|||
1109|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1109|002|Z|does NOT have all possible information about this product. This||
1109|003|Z|information does not assure that this product is safe, effective,||
1109|004|Z|or appropriate for you. This information is not individual||
1109|005|Z|medical advice and does not substitute for the advice of your||
1109|006|Z|health care professional. Always ask your health care||
1109|007|Z|professional for complete information about this product and your||
1109|008|Z|specific health needs.||
1109|009|B|||
1109|010|T|PEG/ELECTROLYTE - ORAL||
1109|011|F|(PEG/ih-LECK-troh-lite)||
1109|012|B|||
1109|013|U|USES:  PEG (polyethylene glycol) with electrolyte is used to||
1109|014|U|clean out the intestines before certain bowel exam procedures||
1109|015|U|such as colonoscopy or barium enema X-rays. It is a laxative that||
1109|016|U|works by drawing large amounts of water into the colon. This||
1109|017|U|effect results in watery bowel movements. Clearing stool from the||
1109|018|U|intestines helps your doctor to better examine the intestines||
1109|019|U|during your procedure.||
1109|020|B|||
1109|021|H|HOW TO USE:  Some brands of this product come with a Medication||
1109|022|H|Guide. If available, read the Medication Guide provided by your||
1109|023|H|pharmacist before you start taking this product. If you have any||
1109|024|H|questions, ask your doctor or pharmacist.||
1109|025|H|   Follow any special diet instructions provided by your doctor.||
1109|026|H|Do not eat solid food, usually starting on the day before your||
1109|027|H|procedure until after your procedure.||
1109|028|H|   This product must be mixed with water as directed before use.||
1109|029|H|Carefully read and follow all directions to mix this product.||
1109|030|H|After mixing, place the container in the refrigerator. Chilling||
1109|031|H|the mixed liquid will improve its taste.||
1109|032|H|   This product may cause certain liquid thickeners (starch-based||
1109|033|H|products) to not work well, which may increase the risk of||
1109|034|H|choking. If you are using liquid thickeners with this product,||
1109|035|H|talk to your pharmacist to select a liquid thickener which will||
1109|036|H|not interact with this product.||
1109|037|H|   The dosage is based on your medical condition, procedure, and||
1109|038|H|response to treatment.||
1109|039|H|   Drink the mixture by mouth as directed by your doctor. It is||
1109|040|H|best to drink the mixed liquid quickly instead of sipping slowly.||
1109|041|H|The mixture may also be given through a nose-to-stomach||
1109|042|H|(nasogastric) tube. Follow the specific directions given by your||
1109|043|H|doctor for when and how much to drink. Be sure to finish drinking||
1109|044|H|the amount directed by your doctor.||
1109|045|H|   Watery bowel movements usually begin within 1 hour after you||
1109|046|H|start to drink the mixed liquid. Drink plenty of clear liquids as||
1109|047|H|directed by your doctor to prevent becoming dehydrated.||
1109|048|H|   Avoid taking other medications by mouth within 1 hour before||
1109|049|H|you start taking this product. Doing so may make the other||
1109|050|H|medication work less well. Ask your doctor or pharmacist if you||
1109|051|H|are not sure when to take your other medications.||
1109|052|B|||
1109|053|S|SIDE EFFECTS:  Nausea, bloating, or feelings of fullness in the||
1109|054|S|stomach/abdomen are very common. Stomach/abdominal cramps,||
1109|055|S|vomiting, and anal irritation occur less often. If any of these||
1109|056|S|effects last or get worse, tell your doctor or pharmacist||
1109|057|S|promptly.||
1109|058|S|   Remember that this medication has been prescribed because your||
1109|059|S|doctor has judged that the benefit to you is greater than the||
1109|060|S|risk of side effects. Many people using this medication do not||
1109|061|S|have serious side effects.||
1109|062|S|   Tell your doctor right away if you have any serious side||
1109|063|S|effects, including: stomach/abdominal pain that is severe or||
1109|064|S|doesn't go away, vomit that is bloody or looks like coffee||
1109|065|S|grounds, chest pain, fainting, fast/irregular heartbeat, sudden||
1109|066|S|shortness of breath, bloody stools, rectal bleeding, seizure,||
1109|067|S|signs of kidney problems (such as change in the amount of urine).||
1109|068|S|   A very serious allergic reaction to this drug is rare.||
1109|069|S|However, get medical help right away if you notice any symptoms||
1109|070|S|of a serious allergic reaction, including: rash, itching/swelling||
1109|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1109|072|S|breathing.||
1109|073|S|   This is not a complete list of possible side effects. If you||
1109|074|S|notice other effects not listed above, contact your doctor or||
1109|075|S|pharmacist.||
1109|076|S|   In the US -||
1109|077|S|   Call your doctor for medical advice about side effects. You||
1109|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1109|079|S|www.fda.gov/medwatch.||
1109|080|S|   In Canada - Call your doctor for medical advice about side||
1109|081|S|effects. You may report side effects to Health Canada at||
1109|082|S|1-866-234-2345.||
1109|083|B|||
1109|084|P|PRECAUTIONS:  Before taking electrolyte with PEG, tell your||
1109|085|P|doctor or pharmacist if you are allergic to it; or if you have||
1109|086|P|any other allergies. This product may contain inactive||
1109|087|P|ingredients, which can cause allergic reactions or other||
1109|088|P|problems. Talk to your pharmacist for more details.||
1109|089|P|   Before using this medication, tell your doctor or pharmacist||
1109|090|P|your medical history, especially of: certain stomach/intestinal||
1109|091|P|problems (such as toxic colitis, obstruction, ulcerative||
1109|092|P|colitis), trouble swallowing (such as poor gag reflex,||
1109|093|P|aspiration), history of vomiting easily/often, heart problems||
1109|094|P|(such as heart failure, irregular heartbeat, QT prolongation in||
1109|095|P|the EKG), kidney problems, seizure disorder, mineral imbalances||
1109|096|P|(such as low level of sodium in the blood).||
1109|097|P|   Before having surgery, tell your doctor or dentist about all||
1109|098|P|the products you use (including prescription drugs,||
1109|099|P|nonprescription drugs, and herbal products).||
1109|100|P|   Children may be more sensitive to the side effects of this||
1109|101|P|drug, especially dehydration. Room temperature solution is better||
1109|102|P|for infants. Children younger than 2 years may be more likely to||
1109|103|P|develop low blood sugar from not eating. Get medical help right||
1109|104|P|away if you notice symptoms of low blood sugar in your child,||
1109|105|P|such as shakiness, unusual sleepiness, abnormal/prolonged crying.||
1109|106|P|   During pregnancy, this medication should be used only when||
1109|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
1109|108|P|   It is unknown if this drug passes into breast milk. Consult||
1109|109|P|your doctor before breastfeeding.||
1109|110|B|||
1109|111|I|DRUG INTERACTIONS:  See also How to Use section.||
1109|112|I|   Drug interactions may change how your medications work or||
1109|113|I|increase your risk for serious side effects. This document does||
1109|114|I|not contain all possible drug interactions. Keep a list of all||
1109|115|I|the products you use (including prescription/nonprescription||
1109|116|I|drugs and herbal products) and share it with your doctor and||
1109|117|I|pharmacist. Do not start, stop, or change the dosage of any||
1109|118|I|medicines without your doctor's approval.||
1109|119|B|||
1109|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1109|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1109|122|O|poison control center right away. US residents can call||
1109|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1109|124|B|||
1109|125|N|NOTES:  Do not share this medication with others.||
1109|126|B|||
1109|127|D|MISSED DOSE:  Not applicable.||
1109|128|B|||
1109|129|R|STORAGE:  Different brands of this medication have different||
1109|130|R|storage needs. Check the product package for instructions on how||
1109|131|R|to store your brand, or ask your pharmacist. Keep all medications||
1109|132|R|away from children and pets.||
1109|133|R|   Do not flush medications down the toilet or pour them into a||
1109|134|R|drain unless instructed to do so. Properly discard this product||
1109|135|R|when it is expired or no longer needed. Consult your pharmacist||
1109|136|R|or local waste disposal company.||
1109|137|B|||
1109|138|A|Information last revised May 2024.||
1109|139|A|Copyright(c) 2025 First Databank, Inc.||
1109|140|B|||
1110|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1110|002|Z|does NOT have all possible information about this product. This||
1110|003|Z|information does not assure that this product is safe, effective,||
1110|004|Z|or appropriate for you. This information is not individual||
1110|005|Z|medical advice and does not substitute for the advice of your||
1110|006|Z|health care professional. Always ask your health care||
1110|007|Z|professional for complete information about this product and your||
1110|008|Z|specific health needs.||
1110|009|B|||
1110|010|T|BETAMETHASONE/CALCIPOTRIENE (CALCIPOTRIOL) SCALP - TOPICAL||
1110|011|F|(BAY-ta-METH-a-sone/KAL-si-poe-TRYE-een/KAL-si-poe-TRYE-ol)||
1110|012|B|||
1110|013|C|COMMON BRAND NAME(S): Taclonex Scalp||
1110|014|B|||
1110|015|U|USES:  This product contains 2 drugs (betamethasone and||
1110|016|U|calcipotriene) and is used to treat psoriasis of the scalp. Some||
1110|017|U|brands of this medication are also used to treat psoriasis on the||
1110|018|U|body. Betamethasone is a very strong corticosteroid drug that||
1110|019|U|helps decrease the swelling, redness, and itching of the skin||
1110|020|U|that occurs with this condition. Calcipotriene, which is also||
1110|021|U|known as calcipotriol in other countries, is a form of vitamin D.||
1110|022|U|It works by slowing down the growth of skin cells so that they do||
1110|023|U|not build up into thickened, scaly skin patches.||
1110|024|U|   This medication should not be used if you have certain types||
1110|025|U|of psoriasis (skin patches with pus-filled blisters, psoriasis||
1110|026|U|with intense redness/shedding/oozing). Consult your doctor for||
1110|027|U|more information.||
1110|028|U|   This product is not recommended for use in children because||
1110|029|U|they may be at an increased risk for side effects. See also Side||
1110|030|U|Effects and Precautions sections.||
1110|031|B|||
1110|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1110|033|H|from your pharmacist before you start using this product and each||
1110|034|H|time you get a refill. If you have any questions, ask your doctor||
1110|035|H|or pharmacist.||
1110|036|H|   This medication is for use on the scalp. Do not apply this||
1110|037|H|product 12 hours before or after any chemical treatments to your||
1110|038|H|hair. Shake the bottle well before use. Part your hair, apply the||
1110|039|H|product only to the affected area(s) of the scalp, and gently rub||
1110|040|H|in as directed by your doctor, usually once daily. Wash your||
1110|041|H|hands after using, but do not wash your hair right after applying||
1110|042|H|this product. Avoid getting any medication in the eyes or ears.||
1110|043|H|If this occurs, immediately rinse with plenty of water. Do not||
1110|044|H|apply this product to the face, underarms, or groin area.||
1110|045|H|   If your doctor has directed you to use this product on your||
1110|046|H|body, follow your doctor's directions for how much to use and||
1110|047|H|where to use it. Apply to affected areas and gently rub in. Wash||
1110|048|H|your hands after using.||
1110|049|H|   Do not use this medication more often or for longer than||
1110|050|H|directed. Do not use more than 100 grams of this product a week||
1110|051|H|unless directed and closely monitored by your doctor. Do not||
1110|052|H|bandage, wrap, or cover the treated area unless your doctor||
1110|053|H|instructs you to do so. Do not use this product on large areas of||
1110|054|H|damaged skin. Following these instructions helps to reduce your||
1110|055|H|risk of side effects.||
1110|056|H|   Tell your doctor if your condition does not get better or if||
1110|057|H|it gets worse. It may take up to 2 weeks to see any improvement.||
1110|058|B|||
1110|059|S|SIDE EFFECTS:  Itching, burning, redness, or irritation of the||
1110|060|S|skin may occur. If any of these effects last or get worse, tell||
1110|061|S|your doctor or pharmacist promptly.||
1110|062|S|   Remember that this medication has been prescribed because your||
1110|063|S|doctor has judged that the benefit to you is greater than the||
1110|064|S|risk of side effects. Many people using this medication do not||
1110|065|S|have serious side effects.||
1110|066|S|   Tell your doctor right away if you have any serious side||
1110|067|S|effects, including: skin thinning/discoloration/"stretch marks",||
1110|068|S|small red bumps on the skin (folliculitis), worsening of||
1110|069|S|psoriasis.||
1110|070|S|   This medication may rarely cause an increase in the level of||
1110|071|S|calcium in your blood or urine. Tell your doctor right away if||
1110|072|S|you notice any of the following unlikely but serious side||
1110|073|S|effects: mental/mood changes, unexplained constipation,||
1110|074|S|pink/bloody urine, painful urination.||
1110|075|S|   Rarely, it is possible this medication will be absorbed from||
1110|076|S|the skin into the bloodstream. This can lead to side effects of||
1110|077|S|too much corticosteroid. These side effects are more likely in||
1110|078|S|children, and in people who use this medication for a long time||
1110|079|S|or over large areas of the skin. Tell your doctor right away if||
1110|080|S|any of the following side effects occur: unusual/extreme||
1110|081|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
1110|082|S|thirst/urination, vision problems.||
1110|083|S|   A very serious allergic reaction to this drug is rare.||
1110|084|S|However, get medical help right away if you notice any symptoms||
1110|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1110|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1110|087|S|breathing.||
1110|088|S|   This is not a complete list of possible side effects. If you||
1110|089|S|notice other effects not listed above, contact your doctor or||
1110|090|S|pharmacist.||
1110|091|S|   In the US -||
1110|092|S|   Call your doctor for medical advice about side effects. You||
1110|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1110|094|S|www.fda.gov/medwatch.||
1110|095|S|   In Canada - Call your doctor for medical advice about side||
1110|096|S|effects. You may report side effects to Health Canada at||
1110|097|S|1-866-234-2345.||
1110|098|B|||
1110|099|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1110|100|P|pharmacist if you are allergic to betamethasone or calcipotriene;||
1110|101|P|or if you have any other allergies. This product may contain||
1110|102|P|inactive ingredients, which can cause allergic reactions or other||
1110|103|P|problems. Talk to your pharmacist for more details.||
1110|104|P|   Before using this medication, tell your doctor your medical||
1110|105|P|history, especially of: a certain mineral imbalance (high calcium||
1110|106|P|levels in the blood or urine), thin skin in the area to be||
1110|107|P|treated, liver disease.||
1110|108|P|   If you have a skin infection (such as chickenpox, herpes||
1110|109|P|simplex) or a skin problem other than psoriasis, it should be||
1110|110|P|treated before you start this medication. Betamethasone and other||
1110|111|P|corticosteroid drugs can slow down your body's response to||
1110|112|P|antibiotic drugs and make it more difficult to clear an||
1110|113|P|infection.||
1110|114|P|   This medication may make you more sensitive to the sun. Limit||
1110|115|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1110|116|P|sunscreen and wear protective clothing when outdoors. Tell your||
1110|117|P|doctor right away if you get sunburned or have skin||
1110|118|P|blisters/redness. Your doctor may direct you to limit or avoid||
1110|119|P|phototherapy while you use this product. Ask your doctor for||
1110|120|P|details.||
1110|121|P|   Rarely, using corticosteroid medications for a long time or||
1110|122|P|over large areas of skin can make it more difficult for your body||
1110|123|P|to respond to physical stress. Before having surgery or emergency||
1110|124|P|treatment, or if you get a serious illness/injury, tell your||
1110|125|P|doctor or dentist that you are using this medication or have used||
1110|126|P|this medication within the past few months.||
1110|127|P|   Though it is unlikely, this medication may temporarily slow||
1110|128|P|down a child's growth if used for a long time. See the doctor||
1110|129|P|regularly so your child's height can be checked.||
1110|130|P|   During pregnancy, this medication should be used only when||
1110|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
1110|132|P|   It is unknown if this drug passes into breast milk. Consult||
1110|133|P|your doctor before breastfeeding.||
1110|134|B|||
1110|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1110|136|I|medications work or increase your risk for serious side effects.||
1110|137|I|This document does not contain all possible drug interactions.||
1110|138|I|Keep a list of all the products you use (including||
1110|139|I|prescription/nonprescription drugs and herbal products) and share||
1110|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
1110|141|I|the dosage of any medicines without your doctor's approval.||
1110|142|B|||
1110|143|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1110|144|O|has overdosed and has serious symptoms such as passing out or||
1110|145|O|trouble breathing, call 911. Otherwise, call a poison control||
1110|146|O|center right away. US residents can call 1-800-222-1222. Canada||
1110|147|O|residents can call 1-844-764-7669.||
1110|148|B|||
1110|149|N|NOTES:  Do not share this medication with others.||
1110|150|N|   Lab and/or medical tests (such as adrenal gland function) may||
1110|151|N|be done while you are using this medication, especially if you||
1110|152|N|use this drug for an extended period of time or apply it over||
1110|153|N|large areas of the body. Keep all medical and lab appointments.||
1110|154|N|Consult your doctor for more details.||
1110|155|N|   Try to identify and reduce the triggers that may worsen your||
1110|156|N|psoriasis (such as stress, skin injury, smoking). Discuss with||
1110|157|N|your doctor additional ways to control symptoms.||
1110|158|B|||
1110|159|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1110|160|D|If it is near the time of the next dose, skip the missed dose.||
1110|161|D|Use your next dose at the regular time. Do not double the dose to||
1110|162|D|catch up.||
1110|163|B|||
1110|164|R|STORAGE:  Store at room temperature. Do not refrigerate. Keep the||
1110|165|R|medication in the outer carton when not in use. Once the bottle||
1110|166|R|is opened, this medication expires after 6 months. Keep all||
1110|167|R|medications away from children and pets.||
1110|168|R|   Do not flush medications down the toilet or pour them into a||
1110|169|R|drain unless instructed to do so. Properly discard this product||
1110|170|R|when it is expired or no longer needed. Consult your pharmacist||
1110|171|R|or local waste disposal company.||
1110|172|B|||
1110|173|A|Information last revised November 2024.||
1110|174|A|Copyright(c) 2025 First Databank, Inc.||
1110|175|B|||
1111|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1111|002|Z|does NOT have all possible information about this product. This||
1111|003|Z|information does not assure that this product is safe, effective,||
1111|004|Z|or appropriate for you. This information is not individual||
1111|005|Z|medical advice and does not substitute for the advice of your||
1111|006|Z|health care professional. Always ask your health care||
1111|007|Z|professional for complete information about this product and your||
1111|008|Z|specific health needs.||
1111|009|B|||
1111|010|T|PEG/ELECTROLYTE 2 LITERS - ORAL||
1111|011|F|(PEG/ih-LECK-troh-lite)||
1111|012|B|||
1111|013|U|USES:  PEG (polyethylene glycol) with electrolyte is used to||
1111|014|U|clean out the intestines before certain bowel exam procedures||
1111|015|U|such as colonoscopy or barium enema X-rays. It is a laxative that||
1111|016|U|works by drawing large amounts of water into the colon. This||
1111|017|U|effect results in watery bowel movements. Clearing stool from the||
1111|018|U|intestines helps your doctor to better examine the intestines||
1111|019|U|during your procedure.||
1111|020|B|||
1111|021|H|HOW TO USE:  Read the Medication Guide provided by your||
1111|022|H|pharmacist before you start taking this medication and each time||
1111|023|H|you get a new prescription for it. If you have any questions, ask||
1111|024|H|your doctor or pharmacist.||
1111|025|H|   Follow any special diet instructions provided by your doctor.||
1111|026|H|Be sure to ask your doctor about acceptable foods/liquids you may||
1111|027|H|eat or drink before the procedure; otherwise the exam may have to||
1111|028|H|be repeated. Finish your evening meal at least 1 hour before||
1111|029|H|starting this medication. After you start drinking this||
1111|030|H|medication, do not eat any solid food until after your procedure||
1111|031|H|is done. To prevent becoming dehydrated, drink plenty of clear||
1111|032|H|liquids as directed by your doctor.||
1111|033|H|   Before using this product, mix it as directed. Read and follow||
1111|034|H|all directions provided by the manufacturer to mix this product.||
1111|035|H|After mixing, you may place the container in the refrigerator||
1111|036|H|until ready to drink. Chilling the mixed liquid may improve its||
1111|037|H|taste.||
1111|038|H|   This product may cause certain liquid thickeners (starch-based||
1111|039|H|products) to not work well, which may increase the risk of||
1111|040|H|choking. If you are using liquid thickeners with this product,||
1111|041|H|talk to your pharmacist to select a liquid thickener which will||
1111|042|H|not interact with this product.||
1111|043|H|   Take this product by mouth without food as directed by your||
1111|044|H|doctor. The dosage is based on your age and medical condition.||
1111|045|H|   The night before your procedure, quickly drink one 8-ounce||
1111|046|H|glass (240 milliliters) of the mixture every 15 minutes until you||
1111|047|H|finish the first container (1 liter), or take as directed by your||
1111|048|H|doctor. Drink the second liter of prepared solution either the||
1111|049|H|night before your procedure (one-and-a-half hours after the first||
1111|050|H|liter) or on the morning of your procedure as directed by your||
1111|051|H|doctor. After drinking each liter of the prepared solution, you||
1111|052|H|should drink additional amounts of water or other clear liquid as||
1111|053|H|directed by your doctor or on the Instructions for Use leaflet.||
1111|054|H|   It is best to drink the mixed liquid quickly instead of||
1111|055|H|sipping slowly. Ask your doctor or pharmacist if you have any||
1111|056|H|questions about how to mix or take this product or what to expect||
1111|057|H|after taking this product.||
1111|058|H|   Watery bowel movements usually begin about 1 hour after you||
1111|059|H|start to drink the mixed liquid. The bowel movements can be very||
1111|060|H|large and watery.||
1111|061|H|   Do not take any other medications by mouth within 1 hour of||
1111|062|H|starting to drink the mixed liquid because your body may not||
1111|063|H|absorb the other medications. Ask your doctor or pharmacist if||
1111|064|H|you are not sure when to take your other medications.||
1111|065|B|||
1111|066|S|SIDE EFFECTS:  Very watery bowel movements are expected with this||
1111|067|S|medication. Nausea, bloating, or feelings of fullness in the||
1111|068|S|stomach/abdomen are very common. Stomach/abdominal cramps,||
1111|069|S|vomiting, and anal irritation occur less often. If any of these||
1111|070|S|effects last or get worse, tell your doctor or pharmacist||
1111|071|S|promptly.||
1111|072|S|   If severe bloating or abdominal pain occurs, drink the mixture||
1111|073|S|more slowly or temporarily stop drinking the mixture until the||
1111|074|S|symptoms improve.||
1111|075|S|   Remember that this medication has been prescribed because your||
1111|076|S|doctor has judged that the benefit to you is greater than the||
1111|077|S|risk of side effects. Many people using this medication do not||
1111|078|S|have serious side effects.||
1111|079|S|   Tell your doctor right away if you have any serious side||
1111|080|S|effects, including: stomach/abdominal pain that is severe or||
1111|081|S|doesn't go away, vomit that is bloody or looks like coffee||
1111|082|S|grounds, chest pain, fast/slow/irregular heartbeat, dizziness,||
1111|083|S|fainting, seizures, sudden shortness of breath, signs of kidney||
1111|084|S|problems (such as change in the amount of urine), bloody stools,||
1111|085|S|rectal bleeding.||
1111|086|S|   A very serious allergic reaction to this drug is rare.||
1111|087|S|However, get medical help right away if you notice any symptoms||
1111|088|S|of a serious allergic reaction, including: rash, itching/swelling||
1111|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1111|090|S|breathing.||
1111|091|S|   This is not a complete list of possible side effects. If you||
1111|092|S|notice other effects not listed above, contact your doctor or||
1111|093|S|pharmacist.||
1111|094|S|   In the US -||
1111|095|S|   Call your doctor for medical advice about side effects. You||
1111|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1111|097|S|www.fda.gov/medwatch.||
1111|098|S|   In Canada - Call your doctor for medical advice about side||
1111|099|S|effects. You may report side effects to Health Canada at||
1111|100|S|1-866-234-2345.||
1111|101|B|||
1111|102|P|PRECAUTIONS:  Before taking PEG with electrolyte, tell your||
1111|103|P|doctor or pharmacist if you are allergic to it; or if you have||
1111|104|P|any other allergies. This product may contain inactive||
1111|105|P|ingredients, which can cause allergic reactions or other||
1111|106|P|problems. Talk to your pharmacist for more details.||
1111|107|P|   Before using this medication, tell your doctor or pharmacist||
1111|108|P|your medical history, especially of: stomach/intestinal problems||
1111|109|P|(such as hole in the intestines, ulcers, blockage, toxic colitis,||
1111|110|P|toxic megacolon, ulcerative colitis, ileus), swallowing problems,||
1111|111|P|history of vomiting easily/often, certain metabolic problem (G6PD||
1111|112|P|deficiency), kidney problems, heart problems (such as irregular||
1111|113|P|heartbeat), seizures, mineral imbalances (such as low level of||
1111|114|P|sodium in the blood).||
1111|115|P|   This medicine may contain aspartame. If you have||
1111|116|P|phenylketonuria (PKU) or any other condition that requires you to||
1111|117|P|restrict your intake of aspartame (or phenylalanine), consult||
1111|118|P|your doctor or pharmacist about using this drug safely.||
1111|119|P|   Older adults may be more sensitive to the side effects of this||
1111|120|P|drug, especially dehydration and loss of salts in the blood (such||
1111|121|P|as potassium, sodium).||
1111|122|P|   Children may be more sensitive to the side effects of this||
1111|123|P|drug, especially dehydration and loss of salts in the blood (such||
1111|124|P|as potassium, sodium).||
1111|125|P|   During pregnancy, this medication should be used only when||
1111|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
1111|127|P|   It is unknown if this drug passes into breast milk. Consult||
1111|128|P|your doctor before breastfeeding.||
1111|129|B|||
1111|130|I|DRUG INTERACTIONS:  See also How to Use section.||
1111|131|I|   Drug interactions may change how your medications work or||
1111|132|I|increase your risk for serious side effects. This document does||
1111|133|I|not contain all possible drug interactions. Keep a list of all||
1111|134|I|the products you use (including prescription/nonprescription||
1111|135|I|drugs and herbal products) and share it with your doctor and||
1111|136|I|pharmacist. Do not start, stop, or change the dosage of any||
1111|137|I|medicines without your doctor's approval.||
1111|138|I|   Some products (especially drugs that can change the amount of||
1111|139|I|water, sodium, or potassium in your body) that may interact with||
1111|140|I|this drug include: "water pills" such as thiazide diuretics, some||
1111|141|I|heart/blood pressure medications called ACE inhibitors (such as||
1111|142|I|captopril, enalapril).||
1111|143|B|||
1111|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1111|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1111|146|O|poison control center right away. US residents can call||
1111|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1111|148|B|||
1111|149|N|NOTES:  Do not share this medication with others.||
1111|150|N|   Lab tests (such as sodium, potassium levels) may be done||
1111|151|N|before or after taking this medication. Keep all medical and lab||
1111|152|N|appointments. Consult your doctor for more details.||
1111|153|B|||
1111|154|D|MISSED DOSE:  Not applicable.||
1111|155|B|||
1111|156|R|STORAGE:  Store the unmixed powder at room temperature away from||
1111|157|R|light and moisture. Do not store in the bathroom. After mixing||
1111|158|R|the solution, you may store it in the refrigerator. Use within 24||
1111|159|R|hours after mixing. Discard any unused mixture. Keep all||
1111|160|R|medications away from children and pets.||
1111|161|R|   Do not flush medications down the toilet or pour them into a||
1111|162|R|drain unless instructed to do so. Properly discard this product||
1111|163|R|when it is expired or no longer needed. Consult your pharmacist||
1111|164|R|or local waste disposal company.||
1111|165|B|||
1111|166|A|Information last revised May 2024.||
1111|167|A|Copyright(c) 2025 First Databank, Inc.||
1111|168|B|||
1112|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1112|002|Z|does NOT have all possible information about this product. This||
1112|003|Z|information does not assure that this product is safe, effective,||
1112|004|Z|or appropriate for you. This information is not individual||
1112|005|Z|medical advice and does not substitute for the advice of your||
1112|006|Z|health care professional. Always ask your health care||
1112|007|Z|professional for complete information about this product and your||
1112|008|Z|specific health needs.||
1112|009|B|||
1112|010|T|METHYLNALTREXONE - INJECTION||
1112|011|F|(METH-il-nal-TREX-one)||
1112|012|B|||
1112|013|C|COMMON BRAND NAME(S): Relistor||
1112|014|B|||
1112|015|U|USES:  This medication is used to treat constipation caused by||
1112|016|U|opioid medication. It blocks the effect of opioids on the gut||
1112|017|U|without blocking the effect on pain. Methylnaltrexone belongs to||
1112|018|U|a class of medications known as opioid antagonists.||
1112|019|B|||
1112|020|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1112|021|H|provided by your pharmacist before you start using||
1112|022|H|methylnaltrexone and each time you get a refill. Ask your health||
1112|023|H|care professional how to prepare and use this medication. If you||
1112|024|H|have any questions, ask your doctor or pharmacist.||
1112|025|H|   Inject this medication under the skin as directed by your||
1112|026|H|doctor, usually once daily on a set schedule or once every other||
1112|027|H|day as needed. Follow your doctor's instructions carefully. Do||
1112|028|H|not use more than once in 24 hours. The injection is given in the||
1112|029|H|upper arm, abdomen, or thigh. Do not inject into a muscle or||
1112|030|H|vein. The dosage is based on your weight, medical condition, and||
1112|031|H|response to treatment.||
1112|032|H|   Before using, check this product for particles or||
1112|033|H|discoloration. If either is present, do not use the liquid.||
1112|034|H|Before injecting each dose, clean the skin you are going to||
1112|035|H|inject into (the injection site) with rubbing alcohol. Change the||
1112|036|H|injection site each time to lessen injury under the skin. To||
1112|037|H|lessen bruising, do not rub the injection site after a shot.||
1112|038|H|Learn how to store and discard medical supplies safely.||
1112|039|H|   Ask your doctor if you should keep using your usual||
1112|040|H|medications for constipation. This medication is used only for||
1112|041|H|constipation caused by opioids. Stop using methylnaltrexone when||
1112|042|H|you stop using opioid pain medication unless otherwise directed||
1112|043|H|by your doctor.||
1112|044|H|   Make sure you are close to a bathroom after using this||
1112|045|H|medication. This medication works quickly. Most people have a||
1112|046|H|bowel movement within a few minutes to a few hours after using||
1112|047|H|this medication.||
1112|048|H|   Tell your doctor if your condition lasts or gets worse.||
1112|049|B|||
1112|050|S|SIDE EFFECTS:  Stomach/abdominal pain, nausea, gas, dizziness,||
1112|051|S|fever, or diarrhea may occur. Pain, redness, or swelling at the||
1112|052|S|injection site may also occur. If any of these effects lasts or||
1112|053|S|gets worse, tell your doctor or pharmacist promptly.||
1112|054|S|   To reduce the risk of dizziness and lightheadedness, get up||
1112|055|S|slowly when rising from a sitting or lying position.||
1112|056|S|   Remember that this medication has been prescribed because your||
1112|057|S|doctor has judged that the benefit to you is greater than the||
1112|058|S|risk of side effects. Many people using this medication do not||
1112|059|S|have serious side effects.||
1112|060|S|   Stop using methylnaltrexone and tell your doctor right away if||
1112|061|S|you have diarrhea that doesn't stop.||
1112|062|S|   Opioid withdrawal symptoms may occur in some people. Tell your||
1112|063|S|doctor right away if any of these withdrawal symptoms occur:||
1112|064|S|sweating, chills, abdominal cramps, diarrhea, mental/mood changes||
1112|065|S|(such as anxiety, confusion, extreme sleepiness, visual||
1112|066|S|hallucinations), yawning.||
1112|067|S|   This drug may rarely cause a serious tear in the stomach or||
1112|068|S|intestinal wall (perforation). Stop using this medication and get||
1112|069|S|medical help right away if any of these very serious side effects||
1112|070|S|occur: severe stomach/abdominal pain that doesn't go away, fever,||
1112|071|S|severe dizziness, fainting, severe nausea/vomiting.||
1112|072|S|   A very serious allergic reaction to this drug is rare.||
1112|073|S|However, get medical help right away if you notice any symptoms||
1112|074|S|of a serious allergic reaction, including: rash, itching/swelling||
1112|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1112|076|S|breathing.||
1112|077|S|   This is not a complete list of possible side effects. If you||
1112|078|S|notice other effects not listed above, contact your doctor or||
1112|079|S|pharmacist.||
1112|080|S|   In the US -||
1112|081|S|   Call your doctor for medical advice about side effects. You||
1112|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1112|083|S|www.fda.gov/medwatch.||
1112|084|S|   In Canada - Call your doctor for medical advice about side||
1112|085|S|effects. You may report side effects to Health Canada at||
1112|086|S|1-866-234-2345.||
1112|087|B|||
1112|088|P|PRECAUTIONS:  Before using methylnaltrexone, tell your doctor or||
1112|089|P|pharmacist if you are allergic to it; or if you have any other||
1112|090|P|allergies. This product may contain inactive ingredients, which||
1112|091|P|can cause allergic reactions or other problems. Talk to your||
1112|092|P|pharmacist for more details.||
1112|093|P|   Before using this medication, tell your doctor or pharmacist||
1112|094|P|your medical history, especially of: stomach/intestinal problems||
1112|095|P|(such as blockage, ulcers, tumors, Crohn's disease,||
1112|096|P|diverticulitis), kidney disease, liver disease.||
1112|097|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1112|098|P|can make you more dizzy. Do not drive, use machinery, or do||
1112|099|P|anything that needs alertness until you can do it safely. Limit||
1112|100|P|alcoholic beverages. Talk to your doctor if you are using||
1112|101|P|marijuana (cannabis).||
1112|102|P|   Before having surgery, tell your doctor or dentist about all||
1112|103|P|the products you use (including prescription drugs,||
1112|104|P|nonprescription drugs, and herbal products).||
1112|105|P|   During pregnancy, this medication should be used only when||
1112|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
1112|107|P|   It is unknown if this medication passes into breast milk.||
1112|108|P|Consult your doctor before breastfeeding.||
1112|109|B|||
1112|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1112|111|I|medications work or increase your risk for serious side effects.||
1112|112|I|This document does not contain all possible drug interactions.||
1112|113|I|Keep a list of all the products you use (including||
1112|114|I|prescription/nonprescription drugs and herbal products) and share||
1112|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
1112|116|I|the dosage of any medicines without your doctor's approval.||
1112|117|B|||
1112|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1112|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1112|120|O|poison control center right away. US residents can call||
1112|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1112|122|B|||
1112|123|N|NOTES:  Do not share this medication with others.||
1112|124|B|||
1112|125|D|MISSED DOSE:  It is important to get each dose of this medication||
1112|126|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1112|127|D|right away for a new dosing schedule. Do not double the dose to||
1112|128|D|catch up.||
1112|129|B|||
1112|130|R|STORAGE:  Store at room temperature away from light. Do not||
1112|131|R|freeze. If you are using the vial form and draw the medication||
1112|132|R|into a syringe, you may store that syringe at room temperature||
1112|133|R|for up to 24 hours. Each vial is for a single use only. Discard||
1112|134|R|any unused medication remaining in the vial after removing your||
1112|135|R|dose. Keep all medications away from children and pets.||
1112|136|R|   Do not flush medications down the toilet or pour them into a||
1112|137|R|drain unless instructed to do so. Properly discard this product||
1112|138|R|when it is expired or no longer needed. Consult your pharmacist||
1112|139|R|or local waste disposal company.||
1112|140|B|||
1112|141|A|Information last revised October 2024.||
1112|142|A|Copyright(c) 2025 First Databank, Inc.||
1112|143|B|||
1113|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1113|002|Z|does NOT have all possible information about this product. This||
1113|003|Z|information does not assure that this product is safe, effective,||
1113|004|Z|or appropriate for you. This information is not individual||
1113|005|Z|medical advice and does not substitute for the advice of your||
1113|006|Z|health care professional. Always ask your health care||
1113|007|Z|professional for complete information about this product and your||
1113|008|Z|specific health needs.||
1113|009|B|||
1113|010|T|ACETAMINOPHEN/ANTIHISTAMINE - ORAL||
1113|011|B|||
1113|012|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
1113|013|W|too much acetaminophen may cause serious (possibly fatal) liver||
1113|014|W|disease. Adults should not take more than 4000 milligrams (4||
1113|015|W|grams) of acetaminophen a day. People with liver problems and||
1113|016|W|children should take less acetaminophen. Ask your doctor or||
1113|017|W|pharmacist how much acetaminophen is safe to take.||
1113|018|W|   Do not use with any other drug containing acetaminophen||
1113|019|W|without asking your doctor or pharmacist first. Acetaminophen is||
1113|020|W|in many nonprescription and prescription medications (such as||
1113|021|W|pain/fever drugs or cough-and-cold products). Check the labels on||
1113|022|W|all your medicines to see if they contain acetaminophen, and ask||
1113|023|W|your pharmacist if you are unsure.||
1113|024|W|   Get medical help right away if you take too much acetaminophen||
1113|025|W|(overdose), even if you feel well. Overdose symptoms may include||
1113|026|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
1113|027|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
1113|028|W|   Daily alcohol use, especially when combined with||
1113|029|W|acetaminophen, may damage your liver. Avoid alcohol.||
1113|030|B|||
1113|031|U|USES:  This combination product contains 2 medications,||
1113|032|U|acetaminophen and an antihistamine. Acetaminophen helps to reduce||
1113|033|U|fever and/or mild to moderate pain (such as headache, backache,||
1113|034|U|aches/pains due to muscle strain, cold, or flu). The||
1113|035|U|antihistamine in this product may cause drowsiness, so it can||
1113|036|U|also be used as a nighttime sleep aid. Antihistamines can also be||
1113|037|U|used to help relieve allergy or cold symptoms such as watery||
1113|038|U|eyes, itchy eyes/nose/throat, runny nose, and sneezing.||
1113|039|U|   Cough-and-cold products have not been shown to be safe or||
1113|040|U|effective in children younger than 6 years. Do not use this||
1113|041|U|product to treat cold symptoms in children younger than 6 years||
1113|042|U|unless specifically directed by the doctor. Some products (such||
1113|043|U|as long-acting tablets/capsules) are not recommended for use in||
1113|044|U|children younger than 12 years. Ask your doctor or pharmacist for||
1113|045|U|more details about using your product safely.||
1113|046|U|   These products do not cure or shorten the length of the common||
1113|047|U|cold and may cause serious side effects. To decrease the risk for||
1113|048|U|serious side effects, carefully follow all dosage directions. Do||
1113|049|U|not use this product to make a child sleepy. Do not give other||
1113|050|U|cough-and-cold medication that might contain the same or similar||
1113|051|U|ingredients (see also Drug Interactions section). Ask the doctor||
1113|052|U|or pharmacist about other ways to relieve cough and cold symptoms||
1113|053|U|(such as drinking enough fluids, using a humidifier or saline||
1113|054|U|nose drops/spray).||
1113|055|B|||
1113|056|H|HOW TO USE:  See also Warning section.||
1113|057|H|   If you are taking an over-the-counter product, read all||
1113|058|H|directions on the product package before taking this medication.||
1113|059|H|If you have any questions, consult your pharmacist. If your||
1113|060|H|doctor has prescribed this medication, take it as directed.||
1113|061|H|   Take this medication by mouth with or without food or as||
1113|062|H|directed by your doctor. If stomach upset occurs, you may take||
1113|063|H|this medication with food or milk.||
1113|064|H|   If you are using the liquid form, carefully measure your||
1113|065|H|prescribed dose using a medication-measuring device or spoon. Do||
1113|066|H|not use a household spoon because you may not get the correct||
1113|067|H|dose.||
1113|068|H|   If you are using the powder form, follow the instructions on||
1113|069|H|the product package. Some brands should be dissolved in water||
1113|070|H|before swallowing.||
1113|071|H|   If you are taking extended-release capsules, swallow them||
1113|072|H|whole. Do not crush or chew extended-release capsules or tablets.||
1113|073|H|Doing so can release all of the drug at once, increasing the risk||
1113|074|H|of side effects. Also, do not split extended-release tablets||
1113|075|H|unless they have a score line and your doctor or pharmacist tells||
1113|076|H|you to do so. Swallow the whole or split tablet without crushing||
1113|077|H|or chewing.||
1113|078|H|   If you are taking the chewable form of this medication, chew||
1113|079|H|it thoroughly before swallowing.||
1113|080|H|   The dosage is based on your medical condition and response to||
1113|081|H|treatment. Pain medications work best if they are used as the||
1113|082|H|first signs of pain occur. If you wait until the symptoms have||
1113|083|H|worsened, the medication may not work as well.||
1113|084|H|   Do not take this product for pain more than 10 days (adults)||
1113|085|H|or 5 days (children) unless directed by a doctor. Do not take||
1113|086|H|this product for fever more than 3 days unless directed by your||
1113|087|H|doctor. If your condition lasts or gets worse, or if you think||
1113|088|H|you may have a serious medical problem, get medical help right||
1113|089|H|away.||
1113|090|B|||
1113|091|S|SIDE EFFECTS:  See also Warning section.||
1113|092|S|   Dizziness, drowsiness, constipation, stomach upset, blurred||
1113|093|S|vision, or dry mouth/nose/throat may occur. If any of these||
1113|094|S|effects last or get worse, tell your doctor or pharmacist||
1113|095|S|promptly.||
1113|096|S|   If your doctor has prescribed this medication, remember that||
1113|097|S|your doctor has judged that the benefit to you is greater than||
1113|098|S|the risk of side effects. Many people using this medication do||
1113|099|S|not have serious side effects.||
1113|100|S|   Tell your doctor right away if you have any serious side||
1113|101|S|effects, including: mental/mood changes (such as confusion),||
1113|102|S|trouble urinating.||
1113|103|S|   A very serious allergic reaction to this drug is rare.||
1113|104|S|However, get medical help right away if you notice any symptoms||
1113|105|S|of a serious allergic reaction, including: rash, itching/swelling||
1113|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1113|107|S|breathing.||
1113|108|S|   This is not a complete list of possible side effects. If you||
1113|109|S|notice other effects not listed above, contact your doctor or||
1113|110|S|pharmacist.||
1113|111|S|   In the US -||
1113|112|S|   Call your doctor for medical advice about side effects. You||
1113|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1113|114|S|www.fda.gov/medwatch.||
1113|115|S|   In Canada - Call your doctor for medical advice about side||
1113|116|S|effects. You may report side effects to Health Canada at||
1113|117|S|1-866-234-2345.||
1113|118|B|||
1113|119|P|PRECAUTIONS:  See also Warning section.||
1113|120|P|   Before taking this medication, tell your doctor or pharmacist||
1113|121|P|if you are allergic to acetaminophen or antihistamines; or if you||
1113|122|P|have any other allergies. This product may contain inactive||
1113|123|P|ingredients, which can cause allergic reactions or other||
1113|124|P|problems. Talk to your pharmacist for more details.||
1113|125|P|   Before using this medication, tell your doctor or pharmacist||
1113|126|P|your medical history, especially of: breathing problems (such as||
1113|127|P|asthma, chronic obstructive pulmonary disease-COPD), glaucoma,||
1113|128|P|heart disease, high blood pressure, liver disease,||
1113|129|P|stomach/intestinal problems (such as blockage, constipation,||
1113|130|P|ulcers), overactive thyroid gland (hyperthyroidism), urination||
1113|131|P|problems (such as trouble urinating due to enlarged prostate,||
1113|132|P|urinary retention).||
1113|133|P|   This drug may make you dizzy or drowsy or blur your vision.||
1113|134|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1113|135|P|drowsy. Do not drive, use machinery, or do anything that needs||
1113|136|P|alertness or clear vision until you can do it safely. Avoid||
1113|137|P|alcoholic beverages. Talk to your doctor if you are using||
1113|138|P|marijuana (cannabis).||
1113|139|P|   Liquid and powder products may contain alcohol, sugar, and/or||
1113|140|P|aspartame. Caution is advised if you have diabetes, alcohol||
1113|141|P|dependence, liver disease, phenylketonuria (PKU), or any other||
1113|142|P|condition that requires you to limit/avoid these substances in||
1113|143|P|your diet. Ask your doctor or pharmacist about using this product||
1113|144|P|safely.||
1113|145|P|   Some brands of this medication contain sodium. Ask your doctor||
1113|146|P|or pharmacist for more information if you are on a||
1113|147|P|salt-restricted diet or if you have a condition that could be||
1113|148|P|worsened by an increase in salt intake.||
1113|149|P|   Before having surgery, tell your doctor or dentist about all||
1113|150|P|the products you use (including prescription drugs,||
1113|151|P|nonprescription drugs, and herbal products).||
1113|152|P|   Children may be more sensitive to the side effects of||
1113|153|P|antihistamines. In young children, this drug may cause agitation||
1113|154|P|and excitement instead of drowsiness.||
1113|155|P|   Older adults may be more sensitive to the side effects of this||
1113|156|P|drug, especially dizziness, drowsiness, confusion, constipation,||
1113|157|P|or trouble urinating. Dizziness, drowsiness, and confusion can||
1113|158|P|increase the risk of falling.||
1113|159|P|   During pregnancy, this medication should be used only when||
1113|160|P|clearly needed. Discuss the risks and benefits with your doctor.||
1113|161|P|   This drug may pass into breast milk and may have undesirable||
1113|162|P|effects on a nursing infant. Consult your doctor before||
1113|163|P|breastfeeding.||
1113|164|B|||
1113|165|I|DRUG INTERACTIONS:  See also Warning section.||
1113|166|I|   Drug interactions may change how your medications work or||
1113|167|I|increase your risk for serious side effects. This document does||
1113|168|I|not contain all possible drug interactions. Keep a list of all||
1113|169|I|the products you use (including prescription/nonprescription||
1113|170|I|drugs and herbal products) and share it with your doctor and||
1113|171|I|pharmacist. Do not start, stop, or change the dosage of any||
1113|172|I|medicines without your doctor's approval.||
1113|173|I|   Some products that may interact with this drug are:||
1113|174|I|antihistamines applied to the skin (such as diphenhydramine||
1113|175|I|cream, ointment, spray), ketoconazole, levoketoconazole.||
1113|176|I|   Tell your doctor or pharmacist if you are taking other||
1113|177|I|products that cause drowsiness such as opioid pain or cough||
1113|178|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1113|179|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1113|180|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1113|181|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1113|182|I|diphenhydramine).||
1113|183|I|   Antihistamines are ingredients found in many nonprescription||
1113|184|I|products and in some combination prescription medications. Check||
1113|185|I|the labels on all your medicines (such as allergy or||
1113|186|I|cough-and-cold products) because they may also contain an||
1113|187|I|antihistamine or other ingredients that cause drowsiness. Ask||
1113|188|I|your pharmacist about using those products safely.||
1113|189|I|   This medication may interfere with certain medical/lab tests||
1113|190|I|(such as urine 5-HIAA, allergy skin tests), possibly causing||
1113|191|I|false test results. Make sure lab personnel and all your doctors||
1113|192|I|know you use this drug.||
1113|193|B|||
1113|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1113|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1113|196|O|poison control center right away. US residents can call||
1113|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1113|198|O|Symptoms of overdose may include: nausea, vomiting, loss of||
1113|199|O|appetite, sweating, stomach/abdominal pain, extreme tiredness,||
1113|200|O|agitation, confusion, flushing, hallucinations, yellowing||
1113|201|O|eyes/skin, dark urine, seizures. In children, excitement may||
1113|202|O|occur first, and may be followed by: loss of coordination,||
1113|203|O|drowsiness, loss of consciousness, seizures.||
1113|204|B|||
1113|205|N|NOTES:  If your doctor has prescribed this medication, do not||
1113|206|N|share it with others.||
1113|207|N|   Keep all medical and lab appointments.||
1113|208|B|||
1113|209|D|MISSED DOSE:  If you are taking this product on a regular||
1113|210|D|schedule and miss a dose, take it as soon as you remember. If it||
1113|211|D|is near the time of the next dose, skip the missed dose. Take||
1113|212|D|your next dose at the regular time. Do not double the dose to||
1113|213|D|catch up.||
1113|214|B|||
1113|215|R|STORAGE:  Store at room temperature away from light and moisture.||
1113|216|R|Do not store in the bathroom. Do not freeze liquid forms of this||
1113|217|R|product. Keep all medications away from children and pets.||
1113|218|R|   Do not flush medications down the toilet or pour them into a||
1113|219|R|drain unless instructed to do so. Properly discard this product||
1113|220|R|when it is expired or no longer needed. Consult your pharmacist||
1113|221|R|or local waste disposal company.||
1113|222|B|||
1113|223|A|Information last revised May 2025.||
1113|224|A|Copyright(c) 2025 First Databank, Inc.||
1113|225|B|||
1114|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1114|002|Z|does NOT have all possible information about this product. This||
1114|003|Z|information does not assure that this product is safe, effective,||
1114|004|Z|or appropriate for you. This information is not individual||
1114|005|Z|medical advice and does not substitute for the advice of your||
1114|006|Z|health care professional. Always ask your health care||
1114|007|Z|professional for complete information about this product and your||
1114|008|Z|specific health needs.||
1114|009|B|||
1114|010|T|TROSPIUM EXTENDED-RELEASE - ORAL||
1114|011|F|(TROSE-pee-um)||
1114|012|B|||
1114|013|C|COMMON BRAND NAME(S): Sanctura XR||
1114|014|B|||
1114|015|U|USES:  This medication is used to treat an overactive bladder. By||
1114|016|U|relaxing the muscles in the bladder, trospium improves your||
1114|017|U|ability to control your urination. It helps to reduce leaking of||
1114|018|U|urine, feelings of needing to urinate right away, and frequent||
1114|019|U|trips to the bathroom. Trospium belongs to a class of drugs known||
1114|020|U|as antispasmodics. It is also known as an antimuscarinic.||
1114|021|B|||
1114|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1114|023|H|from your pharmacist before you start using trospium and each||
1114|024|H|time you get a refill. If you have any questions, ask your doctor||
1114|025|H|or pharmacist.||
1114|026|H|   Take this medication by mouth on an empty stomach (at least 1||
1114|027|H|hour before a meal) as directed by your doctor, usually once||
1114|028|H|daily. The dosage is based on your medical condition and response||
1114|029|H|to treatment.||
1114|030|H|   Swallow the capsule whole. Do not crush or chew the capsule.||
1114|031|H|Also avoid drinking alcohol or taking any product containing||
1114|032|H|alcohol for 2 hours before and after taking this medication.||
1114|033|H|Alcohol can destroy the long action of the drug and may increase||
1114|034|H|side effects.||
1114|035|H|   If you cannot swallow the capsule, you may open the capsule||
1114|036|H|and place the beads in a small amount of water or directly onto||
1114|037|H|the tongue. Do not crush or chew the beads because doing so may||
1114|038|H|cause the drug to be released too quickly, increasing side||
1114|039|H|effects. Swallow all of the beads right away.||
1114|040|H|   Use this medication regularly to get the most benefit from it.||
1114|041|H|To help you remember, take it at the same time each day.||
1114|042|H|   Tell your doctor if your condition does not get better or if||
1114|043|H|it gets worse.||
1114|044|B|||
1114|045|S|SIDE EFFECTS:  Dry mouth, constipation, stomach upset, dry eyes,||
1114|046|S|dry nose, dizziness, blurred vision, or drowsiness may occur. If||
1114|047|S|any of these effects last or get worse, tell your doctor or||
1114|048|S|pharmacist promptly.||
1114|049|S|   Remember that this medication has been prescribed because your||
1114|050|S|doctor has judged that the benefit to you is greater than the||
1114|051|S|risk of side effects. Many people using this medication do not||
1114|052|S|have serious side effects.||
1114|053|S|   Tell your doctor right away if you have any serious side||
1114|054|S|effects, including: eye pain, difficulty urinating, fast||
1114|055|S|heartbeat, mental/mood changes (such as hallucinations,||
1114|056|S|confusion).||
1114|057|S|   A very serious allergic reaction to this drug is rare.||
1114|058|S|However, get medical help right away if you notice any symptoms||
1114|059|S|of a serious allergic reaction, including: rash, itching/swelling||
1114|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1114|061|S|breathing.||
1114|062|S|   This is not a complete list of possible side effects. If you||
1114|063|S|notice other effects not listed above, contact your doctor or||
1114|064|S|pharmacist.||
1114|065|S|   In the US -||
1114|066|S|   Call your doctor for medical advice about side effects. You||
1114|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1114|068|S|www.fda.gov/medwatch.||
1114|069|S|   In Canada - Call your doctor for medical advice about side||
1114|070|S|effects. You may report side effects to Health Canada at||
1114|071|S|1-866-234-2345.||
1114|072|B|||
1114|073|P|PRECAUTIONS:  Before taking trospium, tell your doctor or||
1114|074|P|pharmacist if you are allergic to it; or if you have any other||
1114|075|P|allergies. This product may contain inactive ingredients, which||
1114|076|P|can cause allergic reactions or other problems. Talk to your||
1114|077|P|pharmacist for more details.||
1114|078|P|   Before using this medication, tell your doctor or pharmacist||
1114|079|P|your medical history, especially of: glaucoma, kidney disease,||
1114|080|P|liver disease, stomach/intestinal problems (such as blockage,||
1114|081|P|constipation, ulcerative colitis), myasthenia gravis, inability||
1114|082|P|to urinate (urinary retention).||
1114|083|P|   This drug may make you dizzy or drowsy or blur your vision.||
1114|084|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1114|085|P|drowsy. Do not drive, use machinery, or do anything that needs||
1114|086|P|alertness or clear vision until you can do it safely. Limit||
1114|087|P|alcoholic beverages. Talk to your doctor if you are using||
1114|088|P|marijuana (cannabis).||
1114|089|P|   This medication may make you sweat less, making you more||
1114|090|P|likely to get heat stroke. Avoid doing things that may cause you||
1114|091|P|to overheat, such as hard work or exercise in hot weather, or||
1114|092|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1114|093|P|and dress lightly. If you overheat, quickly look for a place to||
1114|094|P|cool down and rest. Get medical help right away if you have a||
1114|095|P|fever that does not go away, mental/mood changes, headache, or||
1114|096|P|dizziness.||
1114|097|P|   Older adults may be more sensitive to the side effects of this||
1114|098|P|drug, especially constipation, dry mouth, drowsiness, confusion,||
1114|099|P|or trouble urinating. Drowsiness and confusion can increase the||
1114|100|P|risk of falling.||
1114|101|P|   During pregnancy, this medication should be used only when||
1114|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
1114|103|P|   It is unknown if this drug passes into breast milk. Consult||
1114|104|P|your doctor before breastfeeding.||
1114|105|B|||
1114|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1114|107|I|medications work or increase your risk for serious side effects.||
1114|108|I|This document does not contain all possible drug interactions.||
1114|109|I|Keep a list of all the products you use (including||
1114|110|I|prescription/nonprescription drugs and herbal products) and share||
1114|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
1114|112|I|the dosage of any medicines without your doctor's approval.||
1114|113|I|   Some products that may interact with this drug are: potassium||
1114|114|I|tablets/capsules, pramlintide.||
1114|115|I|   Tell your doctor or pharmacist if you are taking other||
1114|116|I|products that cause drowsiness, including alcohol, marijuana||
1114|117|I|(cannabis), certain antihistamines (such as cetirizine,||
1114|118|I|diphenhydramine), drugs for sleep or anxiety (such as alprazolam,||
1114|119|I|diazepam, zolpidem), muscle relaxants, and opioid pain relievers||
1114|120|I|(such as codeine).||
1114|121|I|   Check the labels on all your medicines (such as allergy or||
1114|122|I|cough-and-cold products) because they may contain ingredients||
1114|123|I|that cause drowsiness. Ask your pharmacist about using those||
1114|124|I|products safely.||
1114|125|B|||
1114|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1114|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1114|128|O|poison control center right away. US residents can call||
1114|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1114|130|O|Symptoms of overdose may include: fast heartbeat, widened pupils.||
1114|131|B|||
1114|132|N|NOTES:  Do not share this medication with others.||
1114|133|B|||
1114|134|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1114|135|D|remember, at least 2 hours after a meal or 1 hour before your||
1114|136|D|next meal. If it is near the time of your next dose, skip the||
1114|137|D|missed dose. Take your next dose at the regular time. Do not||
1114|138|D|double the dose to catch up.||
1114|139|B|||
1114|140|R|STORAGE:  Store at room temperature away from light and moisture.||
1114|141|R|Do not store in the bathroom. Keep all medications away from||
1114|142|R|children and pets.||
1114|143|R|   Do not flush medications down the toilet or pour them into a||
1114|144|R|drain unless instructed to do so. Properly discard this product||
1114|145|R|when it is expired or no longer needed. Consult your pharmacist||
1114|146|R|or local waste disposal company.||
1114|147|B|||
1114|148|A|Information last revised October 2024.||
1114|149|A|Copyright(c) 2025 First Databank, Inc.||
1114|150|B|||
1116|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1116|002|Z|does NOT have all possible information about this product. This||
1116|003|Z|information does not assure that this product is safe, effective,||
1116|004|Z|or appropriate for you. This information is not individual||
1116|005|Z|medical advice and does not substitute for the advice of your||
1116|006|Z|health care professional. Always ask your health care||
1116|007|Z|professional for complete information about this product and your||
1116|008|Z|specific health needs.||
1116|009|B|||
1116|010|T|ROPINIROLE EXTENDED-RELEASE - ORAL||
1116|011|F|(row-PIN-uh-roll)||
1116|012|B|||
1116|013|C|COMMON BRAND NAME(S): Requip XL||
1116|014|B|||
1116|015|U|USES:  This medication is used alone or with other medications to||
1116|016|U|treat Parkinson's disease. It can improve your ability to move||
1116|017|U|and decrease shakiness (tremor), stiffness, slowed movement, and||
1116|018|U|unsteadiness. It may also decrease the number of episodes of not||
1116|019|U|being able to move ("on-off syndrome").||
1116|020|U|   Ropinirole works by helping to restore the balance of a||
1116|021|U|certain natural substance (dopamine) in the brain.||
1116|022|B|||
1116|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1116|024|H|from your pharmacist before you start taking ropinirole and each||
1116|025|H|time you get a refill. If you have any questions, ask your doctor||
1116|026|H|or pharmacist.||
1116|027|H|   Take this medication by mouth with or without food as directed||
1116|028|H|by your doctor, usually once daily. Taking this medication with||
1116|029|H|food may decrease the risk of nausea. Swallow the tablets whole.||
1116|030|H|Do not crush or chew the tablets. Doing so can release all of the||
1116|031|H|drug at once, increasing the risk of side effects.||
1116|032|H|   The dosage is based on your medical condition and response to||
1116|033|H|treatment. Your doctor may direct you to start this medication at||
1116|034|H|a low dose and gradually increase your dose to reduce the risk of||
1116|035|H|side effects. Follow your doctor's instructions carefully.||
1116|036|H|   Use this medication regularly to get the most benefit from it.||
1116|037|H|To help you remember, use it at the same time each day. If you||
1116|038|H|stop taking this medication for several days, you may need to||
1116|039|H|slowly increase your dose back to your previous dosage. Talk with||
1116|040|H|your doctor about how to restart this medication.||
1116|041|H|   Do not stop taking this medication without consulting your||
1116|042|H|doctor. Some conditions may become worse when this medication is||
1116|043|H|suddenly stopped. Also, if you suddenly stop using this||
1116|044|H|medication, you may have withdrawal symptoms (such as anxiety,||
1116|045|H|depression, confusion, fever, muscle stiffness). To help prevent||
1116|046|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1116|047|H|more likely if you have used ropinirole for a long time or in||
1116|048|H|high doses. Tell your doctor or pharmacist right away if you have||
1116|049|H|withdrawal.||
1116|050|H|   Tell your doctor if your condition does not get better or if||
1116|051|H|it gets worse.||
1116|052|B|||
1116|053|S|SIDE EFFECTS:  Nausea, vomiting, drowsiness, dizziness, abdominal||
1116|054|S|pain/discomfort, or headache may occur. If these effects last or||
1116|055|S|get worse, tell your doctor promptly.||
1116|056|S|   Remember that this medication has been prescribed because your||
1116|057|S|doctor has judged that the benefit to you is greater than the||
1116|058|S|risk of side effects. Many people using this medication do not||
1116|059|S|have serious side effects.||
1116|060|S|   You may develop a sudden drop in blood pressure, which can||
1116|061|S|cause dizziness, nausea, and fainting. This is more likely when||
1116|062|S|you are first starting the medication, when your dose is||
1116|063|S|increased, or when you get up suddenly. To lower your risk, get||
1116|064|S|up slowly from a sitting or lying position.||
1116|065|S|   This medication may also raise your blood pressure. Check your||
1116|066|S|blood pressure regularly and tell your doctor if the results are||
1116|067|S|high.||
1116|068|S|   Tell your doctor right away if you have any serious side||
1116|069|S|effects, including: new or worsening uncontrolled movements||
1116|070|S|(dyskinesia), mental/mood changes (such as confusion, agitation,||
1116|071|S|hallucinations), unusual strong urges (such as increased||
1116|072|S|gambling, increased sexual urges).||
1116|073|S|   Some people taking ropinirole have fallen asleep suddenly||
1116|074|S|during their usual daily activities (such as talking on the||
1116|075|S|phone, driving). In some cases, sleep occurred without any||
1116|076|S|feelings of drowsiness beforehand. This sleep effect may occur||
1116|077|S|anytime during treatment with ropinirole even if you have used||
1116|078|S|this medication for a long time. If you experience increased||
1116|079|S|sleepiness or fall asleep during the day, do not drive or take||
1116|080|S|part in other possibly dangerous activities until you have||
1116|081|S|discussed this effect with your doctor. Your risk of this sleep||
1116|082|S|effect is increased by using alcohol or other medications that||
1116|083|S|can make you drowsy. See also Precautions section.||
1116|084|S|   A very serious allergic reaction to this drug is rare.||
1116|085|S|However, get medical help right away if you notice any symptoms||
1116|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1116|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1116|088|S|breathing.||
1116|089|S|   This is not a complete list of possible side effects. If you||
1116|090|S|notice other effects not listed above, contact your doctor or||
1116|091|S|pharmacist.||
1116|092|S|   In the US -||
1116|093|S|   Call your doctor for medical advice about side effects. You||
1116|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1116|095|S|www.fda.gov/medwatch.||
1116|096|S|   In Canada - Call your doctor for medical advice about side||
1116|097|S|effects. You may report side effects to Health Canada at||
1116|098|S|1-866-234-2345.||
1116|099|B|||
1116|100|P|PRECAUTIONS:  Before taking ropinirole, tell your doctor or||
1116|101|P|pharmacist if you are allergic to it; or if you have any other||
1116|102|P|allergies. This product may contain inactive ingredients, which||
1116|103|P|can cause allergic reactions or other problems. Talk to your||
1116|104|P|pharmacist for more details.||
1116|105|P|   Before using this medication, tell your doctor or pharmacist||
1116|106|P|your medical history, especially of: heart disease, high or low||
1116|107|P|blood pressure, sleep disorder (such as sleep apnea, narcolepsy),||
1116|108|P|mental/mood disorder, liver problems.||
1116|109|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1116|110|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1116|111|P|machinery, or do anything that needs alertness until you can do||
1116|112|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1116|113|P|are using marijuana (cannabis). See also Side Effects section.||
1116|114|P|   Before having surgery, tell your doctor or dentist about all||
1116|115|P|the products you use (including prescription drugs,||
1116|116|P|nonprescription drugs, and herbal products).||
1116|117|P|   Older adults may be more sensitive to the side effects of this||
1116|118|P|drug, especially mental/mood changes (such as hallucinations),||
1116|119|P|nausea, and vomiting.||
1116|120|P|   During pregnancy, this medication should be used only when||
1116|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
1116|122|P|   It is unknown if this medication passes into breast milk.||
1116|123|P|Consult your doctor before breastfeeding.||
1116|124|B|||
1116|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1116|126|I|medications work or increase your risk for serious side effects.||
1116|127|I|This document does not contain all possible drug interactions.||
1116|128|I|Keep a list of all the products you use (including||
1116|129|I|prescription/nonprescription drugs and herbal products) and share||
1116|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
1116|131|I|the dosage of any medicines without your doctor's approval.||
1116|132|I|   A product that may interact with this drug is: metoclopramide.||
1116|133|I|   Other medications can affect the removal of ropinirole from||
1116|134|I|your body, which may affect how ropinirole works. Examples||
1116|135|I|include cimetidine, fluvoxamine, mexiletine, omeprazole, among||
1116|136|I|others.||
1116|137|I|   Tell your doctor or pharmacist if you are taking other||
1116|138|I|products that can cause drowsiness, including alcohol, marijuana||
1116|139|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1116|140|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1116|141|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1116|142|I|codeine).||
1116|143|I|   Check the labels on all your medicines (such as allergy or||
1116|144|I|cough-and-cold products) because they may contain ingredients||
1116|145|I|that cause drowsiness. Ask your pharmacist about using those||
1116|146|I|products safely.||
1116|147|I|   Cigarette smoking decreases blood levels of this medication.||
1116|148|I|Tell your doctor if you smoke or if you have recently stopped||
1116|149|I|smoking.||
1116|150|B|||
1116|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1116|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1116|153|O|poison control center right away. US residents can call||
1116|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1116|155|B|||
1116|156|N|NOTES:  Do not share this medication with others.||
1116|157|B|||
1116|158|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1116|159|D|remember. If it is near the time of the next dose, skip the||
1116|160|D|missed dose. Take your next dose at the regular time. Do not||
1116|161|D|double the dose to catch up.||
1116|162|B|||
1116|163|R|STORAGE:  Store at room temperature away from light and moisture.||
1116|164|R|Do not store in the bathroom. Keep all medications away from||
1116|165|R|children and pets.||
1116|166|R|   Do not flush medications down the toilet or pour them into a||
1116|167|R|drain unless instructed to do so. Properly discard this product||
1116|168|R|when it is expired or no longer needed. Consult your pharmacist||
1116|169|R|or local waste disposal company.||
1116|170|B|||
1116|171|A|Information last revised May 2024.||
1116|172|A|Copyright(c) 2025 First Databank, Inc.||
1116|173|B|||
1117|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1117|002|Z|does NOT have all possible information about this product. This||
1117|003|Z|information does not assure that this product is safe, effective,||
1117|004|Z|or appropriate for you. This information is not individual||
1117|005|Z|medical advice and does not substitute for the advice of your||
1117|006|Z|health care professional. Always ask your health care||
1117|007|Z|professional for complete information about this product and your||
1117|008|Z|specific health needs.||
1117|009|B|||
1117|010|T|DIPHTHERIA/TETANUS/PERTUSSIS/POLIO/HAEMOPHILUS VACCINE-INJECTION||
1117|011|F|(dip-THEER-ee-uh/TET-un-us/per-TUSS-iss/POE-lee-oh/||
1117|012|F|hee-MAW-fih-liss)||
1117|013|B|||
1117|014|C|COMMON BRAND NAME(S): Pentacel||
1117|015|B|||
1117|016|U|USES:  This vaccine is used to help prevent diphtheria, tetanus||
1117|017|U|(lockjaw), pertussis (whooping cough), polio, and Haemophilus||
1117|018|U|influenzae B infection. Vaccination is the best way to protect||
1117|019|U|against these life-threatening infections. This vaccine works by||
1117|020|U|increasing the body's natural defense (immunity) against the||
1117|021|U|bacteria/virus.||
1117|022|U|   This vaccine is usually given to children between 6 weeks and||
1117|023|U|4 years old.||
1117|024|U|   Vaccines may not fully protect everyone who receives them.||
1117|025|B|||
1117|026|H|HOW TO USE:  Read all vaccine information available from your||
1117|027|H|health care professional before receiving the vaccine. If you||
1117|028|H|have any questions, ask your health care professional.||
1117|029|H|   This vaccine is given by injection into a muscle by a health||
1117|030|H|care professional. It is given in the upper arm for children and||
1117|031|H|in the thigh for infants.||
1117|032|H|   Vaccines are usually given in a series of doses to provide the||
1117|033|H|best protection. Closely follow the vaccination schedule provided||
1117|034|H|by your health care professional. To help you remember, mark your||
1117|035|H|calendar with a reminder.||
1117|036|H|   This vaccine may be given at the same time as other vaccines.||
1117|037|B|||
1117|038|S|SIDE EFFECTS:  Pain/swelling/redness at the injection site,||
1117|039|S|fever, irritability/crying, vomiting, loss of appetite, and||
1117|040|S|diarrhea may occur. If any of these effects last or get worse,||
1117|041|S|tell the health care professional promptly.||
1117|042|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1117|043|S|vision changes, or ringing in the ears just after getting a||
1117|044|S|vaccine injection. Tell the health care professional right away||
1117|045|S|if your child has any of these symptoms. Sitting or lying down||
1117|046|S|may help, since these symptoms usually don't last long.||
1117|047|S|   Remember that this vaccine has been prescribed because the||
1117|048|S|health care professional has judged that the benefit to your||
1117|049|S|child is greater than the risk of side effects. Many people using||
1117|050|S|this vaccine do not have serious side effects.||
1117|051|S|   Tell your health care professional right away if your child||
1117|052|S|has any serious side effects, including: high fever (105 degrees||
1117|053|S|F/40 degrees C or higher), nonstop crying (beginning within 48||
1117|054|S|hours of the injection and lasting longer than 3 hours),||
1117|055|S|seizures, little or no response to sound/touch, weak/floppy||
1117|056|S|muscles, severe pain/swelling at the injection site.||
1117|057|S|   A very serious allergic reaction to this vaccine is rare.||
1117|058|S|However, get medical help right away if you notice any symptoms||
1117|059|S|of a serious allergic reaction, including: rash, itching/swelling||
1117|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1117|061|S|breathing.||
1117|062|S|   This is not a complete list of possible side effects. If you||
1117|063|S|notice other effects not listed above, contact the health care||
1117|064|S|professional.||
1117|065|S|   Contact the health care professional for medical advice about||
1117|066|S|side effects. The following numbers do not provide medical||
1117|067|S|advice, but in the US you may report side effects to the Vaccine||
1117|068|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1117|069|S|Canada, you may call the Vaccine Safety Section at Public Health||
1117|070|S|Agency of Canada at 1-866-844-0018.||
1117|071|B|||
1117|072|P|PRECAUTIONS:  Before your child receives this vaccine, tell the||
1117|073|P|health care professional if your child is allergic to it; or if||
1117|074|P|your child has any other allergies. This product may contain||
1117|075|P|inactive ingredients (such as latex), which can cause allergic||
1117|076|P|reactions or other problems. Talk to your health care||
1117|077|P|professional for more details.||
1117|078|P|   Before receiving this vaccine, tell the health care||
1117|079|P|professional your child's medical history, especially of: current||
1117|080|P|fever/illness, nervous system disorders (such as seizures,||
1117|081|P|encephalopathy, Guillain-Barre syndrome), immune system disorders||
1117|082|P|(such as due to HIV infection, certain cancers such as||
1117|083|P|leukemia/lymphoma, cancer or radiation treatment), vaccination||
1117|084|P|history (including previous reactions to any vaccines).||
1117|085|P|   This vaccine is not usually used by adults. It is unlikely to||
1117|086|P|be used during pregnancy or breastfeeding. Consult the health||
1117|087|P|care professional if you have any questions about using this||
1117|088|P|vaccine.||
1117|089|B|||
1117|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1117|091|I|medications work or increase your risk for serious side effects.||
1117|092|I|This document does not contain all possible drug interactions.||
1117|093|I|Keep a list of all the products your child uses (including||
1117|094|I|prescription/nonprescription drugs and herbal products) and share||
1117|095|I|it with the health care professional. Do not start, stop, or||
1117|096|I|change the dosage of any medicines without the doctor's approval.||
1117|097|I|   Some products that may interact with this vaccine are: drugs||
1117|098|I|that weaken the immune system (including cyclosporine,||
1117|099|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1117|100|I|prednisone).||
1117|101|I|   This vaccine may interfere with certain lab tests (such as||
1117|102|I|antigen tests), possibly causing false test results. Make sure||
1117|103|I|lab personnel and all the doctors know your child recently||
1117|104|I|received this vaccine.||
1117|105|B|||
1117|106|O|OVERDOSE:  Not applicable.||
1117|107|B|||
1117|108|N|NOTES:  Keep all medical and lab appointments.||
1117|109|N|   Keep vaccine records for yourself and your children and||
1117|110|N|provide them to the health care professionals to prevent||
1117|111|N|unnecessary re-vaccinations.||
1117|112|B|||
1117|113|D|MISSED DOSE:  It is important that your child gets each||
1117|114|D|vaccination as scheduled. Ask when your child should get each||
1117|115|D|dose and mark your calendar with a reminder. If your child misses||
1117|116|D|a dose, call the health care professional to reschedule.||
1117|117|B|||
1117|118|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
1117|119|R|light. Keep all medications away from children and pets.||
1117|120|R|   Do not flush medications down the toilet or pour them into a||
1117|121|R|drain unless instructed to do so. Properly discard this product||
1117|122|R|when it is expired or no longer needed. Consult your pharmacist||
1117|123|R|or local waste disposal company.||
1117|124|B|||
1117|125|A|Information last revised February 2025.||
1117|126|A|Copyright(c) 2025 First Databank, Inc.||
1117|127|B|||
1119|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1119|002|Z|does NOT have all possible information about this product. This||
1119|003|Z|information does not assure that this product is safe, effective,||
1119|004|Z|or appropriate for you. This information is not individual||
1119|005|Z|medical advice and does not substitute for the advice of your||
1119|006|Z|health care professional. Always ask your health care||
1119|007|Z|professional for complete information about this product and your||
1119|008|Z|specific health needs.||
1119|009|B|||
1119|010|T|DIPHTHERIA/TETANUS/PERTUSSIS/POLIO VACCINE - INJECTION||
1119|011|F|(dip-THEER-ee-uh/TET-un-us/per-TUSS-iss/POE-lee-oh)||
1119|012|B|||
1119|013|C|COMMON BRAND NAME(S): Kinrix, Quadracel||
1119|014|B|||
1119|015|U|USES:  This vaccine is used to help prevent diphtheria, tetanus||
1119|016|U|(lockjaw), pertussis (whooping cough), and polio. Vaccination is||
1119|017|U|the best way to protect against these life-threatening diseases.||
1119|018|U|This vaccine works by increasing the body's natural defense||
1119|019|U|(immunity) against the bacteria/virus.||
1119|020|U|   Vaccines may not fully protect everyone who receives them.||
1119|021|B|||
1119|022|H|HOW TO USE:  Read all vaccine information available from your||
1119|023|H|health care professional before receiving the vaccine. If you||
1119|024|H|have any questions, ask your health care professional.||
1119|025|H|   This vaccine is given by injection into a muscle by a health||
1119|026|H|care professional. It is given in the upper arm for children and||
1119|027|H|adults and in the thigh for infants.||
1119|028|H|   Vaccines are usually given in a series of doses to provide the||
1119|029|H|best protection. Closely follow the vaccination schedule provided||
1119|030|H|by the health care professional. To help you remember, mark your||
1119|031|H|calendar with a reminder.||
1119|032|B|||
1119|033|S|SIDE EFFECTS:  Pain/swelling/redness at the injection site,||
1119|034|S|fever, tiredness, headache, nausea, and loss of appetite may||
1119|035|S|occur. If any of these effects last or get worse, tell the health||
1119|036|S|care professional promptly.||
1119|037|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1119|038|S|vision changes, or ringing in the ears just after getting a||
1119|039|S|vaccine injection. Tell the health care professional right away||
1119|040|S|if you have any of these symptoms. Sitting or lying down may||
1119|041|S|help, since these symptoms usually don't last long.||
1119|042|S|   Remember that this vaccine has been prescribed because the||
1119|043|S|health care professional has judged that the benefit to you or||
1119|044|S|your child is greater than the risk of side effects. Many people||
1119|045|S|using this vaccine do not have serious side effects.||
1119|046|S|   Tell your health care professional right away if you or your||
1119|047|S|child have any serious side effects, including: high fever (105||
1119|048|S|degrees F/40 degrees C or higher), seizures, muscle weakness,||
1119|049|S|numbness/tingling, severe pain/swelling at the injection site.||
1119|050|S|   A very serious allergic reaction to this vaccine is rare.||
1119|051|S|However, get medical help right away if you notice any symptoms||
1119|052|S|of a serious allergic reaction, including: rash, itching/swelling||
1119|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1119|054|S|breathing.||
1119|055|S|   This is not a complete list of possible side effects. If you||
1119|056|S|notice other effects not listed above, contact the health care||
1119|057|S|professional.||
1119|058|S|   Contact the health care professional for medical advice about||
1119|059|S|side effects. The following numbers do not provide medical||
1119|060|S|advice, but in the US you may report side effects to the Vaccine||
1119|061|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1119|062|S|Canada, you may call the Vaccine Safety Section at Public Health||
1119|063|S|Agency of Canada at 1-866-844-0018.||
1119|064|B|||
1119|065|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
1119|066|P|care professional if you are allergic to it; or if you have any||
1119|067|P|other allergies. This product may contain inactive ingredients||
1119|068|P|(such as latex found in some brands, neomycin, polymyxin B),||
1119|069|P|which can cause allergic reactions or other problems. Talk to||
1119|070|P|your health care professional for more details.||
1119|071|P|   Before receiving this vaccine, tell the health care||
1119|072|P|professional your medical history, especially of: current||
1119|073|P|fever/illness, nervous system disorders (such as seizures,||
1119|074|P|encephalopathy, Guillain-Barre syndrome), immune system disorders||
1119|075|P|(such as due to HIV infection, certain cancers such as||
1119|076|P|leukemia/lymphoma, cancer or radiation treatment), vaccination||
1119|077|P|history (including previous reactions to any vaccines).||
1119|078|P|   During pregnancy, this vaccine should be used only when||
1119|079|P|clearly needed. Discuss the risks and benefits with your health||
1119|080|P|care professional.||
1119|081|P|   It is unknown if this vaccine passes into breast milk. Consult||
1119|082|P|your health care professional before breastfeeding.||
1119|083|B|||
1119|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1119|085|I|medications work or increase your risk for serious side effects.||
1119|086|I|This document does not contain all possible drug interactions.||
1119|087|I|Keep a list of all the products you use (including||
1119|088|I|prescription/nonprescription drugs and herbal products) and share||
1119|089|I|it with your health care professional. Do not start, stop, or||
1119|090|I|change the dosage of any medicines without your doctor's||
1119|091|I|approval.||
1119|092|I|   Some products that may interact with this vaccine are: drugs||
1119|093|I|that weaken the immune system (including cyclosporine,||
1119|094|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1119|095|I|prednisone).||
1119|096|B|||
1119|097|O|OVERDOSE:  Not applicable.||
1119|098|B|||
1119|099|N|NOTES:  Keep all medical and lab appointments.||
1119|100|N|   Keep vaccine records for yourself and your children and||
1119|101|N|provide them to the health care professionals to prevent||
1119|102|N|unnecessary re-vaccinations.||
1119|103|B|||
1119|104|D|MISSED DOSE:  It is important that you or your child gets each||
1119|105|D|vaccination as scheduled. Ask when you or your child should get||
1119|106|D|each dose and mark your calendar with a reminder. If you or your||
1119|107|D|child miss a dose, call the health care professional to||
1119|108|D|reschedule.||
1119|109|B|||
1119|110|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
1119|111|R|medications away from children and pets.||
1119|112|R|   Do not flush medications down the toilet or pour them into a||
1119|113|R|drain unless instructed to do so. Properly discard this product||
1119|114|R|when it is expired or no longer needed. Consult your pharmacist||
1119|115|R|or local waste disposal company.||
1119|116|B|||
1119|117|A|Information last revised February 2025.||
1119|118|A|Copyright(c) 2025 First Databank, Inc.||
1119|119|B|||
1120|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1120|002|Z|does NOT have all possible information about this product. This||
1120|003|Z|information does not assure that this product is safe, effective,||
1120|004|Z|or appropriate for you. This information is not individual||
1120|005|Z|medical advice and does not substitute for the advice of your||
1120|006|Z|health care professional. Always ask your health care||
1120|007|Z|professional for complete information about this product and your||
1120|008|Z|specific health needs.||
1120|009|B|||
1120|010|T|PROGESTERONE - ORAL||
1120|011|F|(pro-JESS-ter-own)||
1120|012|B|||
1120|013|C|COMMON BRAND NAME(S): Prometrium||
1120|014|B|||
1120|015|W|WARNING:  Progesterone is sometimes used with another medication||
1120|016|W|(a type of estrogen) as combination hormone replacement therapy||
1120|017|W|(HRT) in women after menopause. Combination HRT may rarely cause||
1120|018|W|very serious (possibly fatal) problems from blood clots (such as||
1120|019|W|heart attack, stroke, blood clots in the lungs or legs),||
1120|020|W|dementia, and breast cancer. Some of these risks appear to depend||
1120|021|W|on the length of treatment and other factors. Combination HRT||
1120|022|W|should be used for the shortest possible length of time at the||
1120|023|W|lowest effective dose so you can obtain the benefits and minimize||
1120|024|W|the chance of serious side effects from long-term treatment.||
1120|025|W|Combination HRT should not be used to prevent heart disease or||
1120|026|W|dementia. Discuss the risks and benefits of treatment and your||
1120|027|W|personal health history with your doctor. If you take combination||
1120|028|W|HRT, check with your doctor regularly (such as every 3-6 months)||
1120|029|W|to see if you still need to take it.||
1120|030|W|   If you use this medication for an extended period, you should||
1120|031|W|have a complete physical exam at regular intervals (such as once||
1120|032|W|a year) or as directed by your doctor. See also Notes section.||
1120|033|B|||
1120|034|U|USES:  Progesterone is a type of hormone (progestin). This||
1120|035|U|medication is similar to the progesterone that your body||
1120|036|U|naturally makes and is given to replace the hormone when your||
1120|037|U|body is not making enough of it. In women who are not pregnant||
1120|038|U|and not going through menopause, this medication is used to||
1120|039|U|restore normal menstrual periods that have stopped for several||
1120|040|U|months (amenorrhea).||
1120|041|U|   Progesterone is also used as part of combination hormone||
1120|042|U|replacement therapy with estrogens to reduce menopause symptoms||
1120|043|U|(such as hot flashes). Progesterone is added to estrogen||
1120|044|U|replacement therapy to reduce the risk of cancer of the uterus.||
1120|045|U|   This medication is not for use in children.||
1120|046|U|   Progesterone must not be used to test for pregnancy.||
1120|047|B|||
1120|048|V|OTHER USES:  This section contains uses of this drug that are not||
1120|049|V|listed in the approved professional labeling for the drug but||
1120|050|V|that may be prescribed by your health care professional. Use this||
1120|051|V|drug for a condition that is listed in this section only if it||
1120|052|V|has been so prescribed by your health care professional.||
1120|053|V|   This drug may also be used to maintain pregnancy.||
1120|054|B|||
1120|055|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1120|056|H|from your pharmacist before you start using this drug and each||
1120|057|H|time you get a refill. If you have any questions, ask your doctor||
1120|058|H|or pharmacist.||
1120|059|H|   Take this medication by mouth as directed by your doctor,||
1120|060|H|usually once a day at bedtime. If you have trouble swallowing the||
1120|061|H|pills, take with a full glass of water while standing up. Follow||
1120|062|H|the dosing schedule carefully. Ask your doctor if you have any||
1120|063|H|questions. The dosage is based on your medical condition and||
1120|064|H|response to treatment.||
1120|065|H|   Tell your doctor if your condition does not get better or if||
1120|066|H|it gets worse.||
1120|067|B|||
1120|068|S|SIDE EFFECTS:  See also Warning section.||
1120|069|S|   Nausea, bloating, breast tenderness, headache, change in||
1120|070|S|vaginal discharge, mood swings, blurred vision, dizziness, or||
1120|071|S|drowsiness may occur. If any of these effects last or get worse,||
1120|072|S|notify your doctor or pharmacist promptly.||
1120|073|S|   Remember that this medication has been prescribed because your||
1120|074|S|doctor has judged that the benefit to you is greater than the||
1120|075|S|risk of side effects. Many people using this medication do not||
1120|076|S|have serious side effects.||
1120|077|S|   Tell your doctor right away if you have any serious side||
1120|078|S|effects, including: nausea/vomiting that doesn't stop, unusual||
1120|079|S|vaginal bleeding (such as spotting, breakthrough bleeding),||
1120|080|S|mental/mood changes (such as depression, memory loss), swelling||
1120|081|S|of the hands/feet, frequent/burning/painful urination, breast||
1120|082|S|lumps, dark patches on the skin or face (melasma), yellowing||
1120|083|S|eyes/skin, stomach/abdominal pain, dark urine, unusual tiredness.||
1120|084|S|   This medication, especially if used along with an estrogen||
1120|085|S|product, may rarely cause very serious (possibly fatal) problems||
1120|086|S|from blood clots (such as heart attack, stroke, blood clots in||
1120|087|S|the lungs, legs, or eyes). Get medical help right away if you||
1120|088|S|have: chest/jaw/left arm pain, weakness on one side of the body,||
1120|089|S|trouble speaking, sudden vision changes, confusion, sudden/severe||
1120|090|S|headaches, sudden dizziness/fainting, shortness of breath/rapid||
1120|091|S|breathing, pain/swelling/warmth in the groin/calf, unusual||
1120|092|S|sweating.||
1120|093|S|   A very serious allergic reaction to this drug is rare.||
1120|094|S|However, get medical help right away if you notice any symptoms||
1120|095|S|of a serious allergic reaction, including: rash, itching/swelling||
1120|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1120|097|S|breathing.||
1120|098|S|   This is not a complete list of possible side effects. If you||
1120|099|S|notice other effects not listed above, contact your doctor or||
1120|100|S|pharmacist.||
1120|101|S|   In the US -||
1120|102|S|   Call your doctor for medical advice about side effects. You||
1120|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1120|104|S|www.fda.gov/medwatch.||
1120|105|S|   In Canada - Call your doctor for medical advice about side||
1120|106|S|effects. You may report side effects to Health Canada at||
1120|107|S|1-866-234-2345.||
1120|108|B|||
1120|109|P|PRECAUTIONS:  See also Warning section.||
1120|110|P|   Before taking progesterone, tell your doctor or pharmacist if||
1120|111|P|you are allergic to it; or if you have any other allergies. This||
1120|112|P|product may contain inactive ingredients (such as peanut oil),||
1120|113|P|which can cause allergic reactions or other problems. Talk to||
1120|114|P|your pharmacist for more details.||
1120|115|P|   Before using this medication, tell your doctor or pharmacist||
1120|116|P|your medical history, especially of: blood clots, history of||
1120|117|P|bleeding in the brain, liver disease, vaginal bleeding of unknown||
1120|118|P|cause, a loss of pregnancy with some tissue remaining in the||
1120|119|P|uterus ("missed abortion"), personal or family history of cancer||
1120|120|P|(especially breast or other female organs), kidney disease,||
1120|121|P|obesity, heart disease (such as past heart attacks, coronary||
1120|122|P|artery disease, heart failure), high blood pressure, seizures,||
1120|123|P|migraine headaches, asthma, high blood levels of||
1120|124|P|cholesterol/fats, depression, diabetes, strokes, smoking, lupus.||
1120|125|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1120|126|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1120|127|P|machinery, or do anything that needs alertness until you can do||
1120|128|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1120|129|P|are using marijuana (cannabis).||
1120|130|P|   Before having surgery, tell your doctor or dentist about all||
1120|131|P|the products you use (including prescription drugs,||
1120|132|P|nonprescription drugs, and herbal products).||
1120|133|P|   This medication may cause blotchy, dark areas on your face and||
1120|134|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
1120|135|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
1120|136|P|wear protective clothing when outdoors.||
1120|137|P|   This medication may be used during pregnancy only as directed||
1120|138|P|by your doctor. Discuss the risks and benefits with your doctor.||
1120|139|P|   This drug passes into breast milk. Consult your doctor before||
1120|140|P|breastfeeding.||
1120|141|B|||
1120|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1120|143|I|medications work or increase your risk for serious side effects.||
1120|144|I|This document does not contain all possible drug interactions.||
1120|145|I|Keep a list of all the products you use (including||
1120|146|I|prescription/nonprescription drugs and herbal products) and share||
1120|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
1120|148|I|the dosage of any medicines without your doctor's approval.||
1120|149|I|   This medication may interfere with certain lab tests, possibly||
1120|150|I|causing false test results. Make sure lab personnel and all your||
1120|151|I|doctors know you use this drug.||
1120|152|B|||
1120|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1120|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1120|155|O|poison control center right away. US residents can call||
1120|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1120|157|O|Symptoms of overdose may include severe nausea and vomiting.||
1120|158|B|||
1120|159|N|NOTES:  Do not share this medication with others.||
1120|160|N|   Regular complete physical exams which include lab and/or||
1120|161|N|medical tests (such as blood pressure, breast exam/mammogram,||
1120|162|N|pelvic exam, Pap smear) should be done while you are taking this||
1120|163|N|medication. Follow your doctor's instructions for examining your||
1120|164|N|breasts, and report any lumps right away. Keep all medical and||
1120|165|N|lab appointments. Consult your doctor for more details.||
1120|166|B|||
1120|167|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1120|168|D|remember. If it is near the time of the next dose, skip the||
1120|169|D|missed dose. Take your next dose at the regular time. Do not||
1120|170|D|double the dose to catch up.||
1120|171|B|||
1120|172|R|STORAGE:  Store at room temperature away from light and moisture.||
1120|173|R|Do not store in the bathroom. Keep all medications away from||
1120|174|R|children and pets.||
1120|175|R|   Do not flush medications down the toilet or pour them into a||
1120|176|R|drain unless instructed to do so. Properly discard this product||
1120|177|R|when it is expired or no longer needed. Consult your pharmacist||
1120|178|R|or local waste disposal company.||
1120|179|B|||
1120|180|A|Information last revised October 2024.||
1120|181|A|Copyright(c) 2025 First Databank, Inc.||
1120|182|B|||
1122|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1122|002|Z|does NOT have all possible information about this product. This||
1122|003|Z|information does not assure that this product is safe, effective,||
1122|004|Z|or appropriate for you. This information is not individual||
1122|005|Z|medical advice and does not substitute for the advice of your||
1122|006|Z|health care professional. Always ask your health care||
1122|007|Z|professional for complete information about this product and your||
1122|008|Z|specific health needs.||
1122|009|B|||
1122|010|T|DABIGATRAN - ORAL||
1122|011|F|(DA-bi-GAT-ran)||
1122|012|B|||
1122|013|C|COMMON BRAND NAME(S): Pradaxa||
1122|014|B|||
1122|015|W|WARNING:  Do not stop taking dabigatran unless directed by your||
1122|016|W|doctor. If you stop taking this medication early, you have a||
1122|017|W|higher risk of forming a serious blood clot (such as a stroke,||
1122|018|W|blood clot in the legs/lungs). Your doctor may direct you to take||
1122|019|W|a different "blood thinning" or antiplatelet medication to reduce||
1122|020|W|your risk. Get medical help right away if you have weakness on||
1122|021|W|one side of the body, trouble speaking, sudden vision changes,||
1122|022|W|confusion, chest pain, trouble breathing, or pain/warmth/swelling||
1122|023|W|in the legs.||
1122|024|W|   People taking this medication may bleed near the spinal cord||
1122|025|W|after certain spinal procedures. Bleeding in this area can cause||
1122|026|W|paralysis that lasts a long time or could become permanent.||
1122|027|W|Before any spinal procedure, ask your doctor about the benefits||
1122|028|W|and risks. The risk of bleeding may be higher if you have a||
1122|029|W|deformed spine, or have had spinal procedures/surgery before||
1122|030|W|(such as epidural catheter placement, difficult epidural/spinal||
1122|031|W|puncture), or are taking other drugs that can cause||
1122|032|W|bleeding/bruising (including antiplatelet drugs such as||
1122|033|W|clopidogrel, "blood thinners" such as warfarin/enoxaparin,||
1122|034|W|nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen).||
1122|035|W|Tell your doctor right away if you notice symptoms such as back||
1122|036|W|pain, leg numbness/tingling/weakness, loss of control of the||
1122|037|W|bowels or bladder (incontinence).||
1122|038|B|||
1122|039|U|USES:  Dabigatran is used to prevent stroke and harmful blood||
1122|040|U|clots (such as in your legs or lungs) if you have a certain type||
1122|041|U|of irregular heartbeat (atrial fibrillation). Dabigatran is also||
1122|042|U|used to treat blood clots in the veins of your legs (deep vein||
1122|043|U|thrombosis) or lungs (pulmonary embolism) and to reduce the risk||
1122|044|U|of them occurring again. This medication may also be used to||
1122|045|U|prevent these blood clots from forming after hip replacement||
1122|046|U|surgery. Dabigatran is an anticoagulant that works by blocking a||
1122|047|U|certain substance (a clotting protein called thrombin) in your||
1122|048|U|blood. This helps to keep blood flowing smoothly in your body.||
1122|049|U|   Dabigatran should not be used to prevent blood clots from||
1122|050|U|forming after artificial heart valve replacement. If you have had||
1122|051|U|heart valve surgery, talk to your doctor about the best||
1122|052|U|medication for you. Do not stop taking any medication, including||
1122|053|U|dabigatran, without talking to your doctor first.||
1122|054|B|||
1122|055|V|OTHER USES:  This section contains uses of this drug that are not||
1122|056|V|listed in the approved professional labeling for the drug but||
1122|057|V|that may be prescribed by your health care professional. Use this||
1122|058|V|drug for a condition that is listed in this section only if it||
1122|059|V|has been so prescribed by your health care professional.||
1122|060|V|   This drug may also be used to reduce the risk of blood clots||
1122|061|V|forming in your legs or lungs after knee replacement surgery.||
1122|062|B|||
1122|063|H|HOW TO USE:  See also Warning section.||
1122|064|H|   Read the Medication Guide and, if available, the Patient||
1122|065|H|Information Leaflet provided by your pharmacist before you start||
1122|066|H|taking dabigatran and each time you get a refill. If you have any||
1122|067|H|questions, ask your doctor or pharmacist.||
1122|068|H|   Take this medication by mouth with or without food as directed||
1122|069|H|by your doctor, usually twice a day. Children should take the||
1122|070|H|first dose in the morning and the second dose in the evening||
1122|071|H|(about 12 hours apart). To prevent clots after hip or knee||
1122|072|H|replacement surgery, take it as directed by your doctor, usually||
1122|073|H|once a day. Avoid antacids within 24 hours after surgery, or||
1122|074|H|dabigatran may not work as well. If you have stomach upset while||
1122|075|H|taking this medication, take it with food.||
1122|076|H|   Swallow the capsules whole with a full glass of water (8||
1122|077|H|ounces/240 milliliters). Do not crush, chew, or break open the||
1122|078|H|capsules. Doing so can release all of the drug at once,||
1122|079|H|increasing the risk of side effects. Do not put this medication||
1122|080|H|in a pill box or medication reminder box. It must be kept tightly||
1122|081|H|closed in the original bottle (or blister package) to protect it||
1122|082|H|from moisture. See also Storage section for more important||
1122|083|H|details.||
1122|084|H|   The dosage is based on your medical condition, response to||
1122|085|H|treatment, and other medications you may be taking. Children's||
1122|086|H|dosage is also based on age and weight. Be sure to tell your||
1122|087|H|doctor and pharmacist about all the products you use (including||
1122|088|H|prescription drugs, nonprescription drugs, and herbal products).||
1122|089|H|   Use this medication regularly to get the most benefit from it.||
1122|090|H|To help you remember, take it at the same time(s) each day.||
1122|091|H|   It is very important to take it exactly as directed. Do not||
1122|092|H|increase your dose or take this drug more often than directed. Do||
1122|093|H|not stop taking this medication without consulting your doctor.||
1122|094|B|||
1122|095|S|SIDE EFFECTS:  See also Warning section.||
1122|096|S|   Easy bruising, minor bleeding (such as nosebleed, bleeding||
1122|097|S|from cuts), upset stomach, or heartburn may occur. If any of||
1122|098|S|these effects last or get worse, tell your doctor or pharmacist||
1122|099|S|promptly.||
1122|100|S|   Remember that this medication has been prescribed because your||
1122|101|S|doctor has judged that the benefit to you is greater than the||
1122|102|S|risk of side effects. Many people using this medication do not||
1122|103|S|have serious side effects.||
1122|104|S|   This medication can cause serious bleeding if it affects your||
1122|105|S|blood clotting proteins too much. Tell your doctor right away if||
1122|106|S|you have any signs of serious bleeding, including: nosebleeds||
1122|107|S|that happen often or don't stop, unusual tiredness/weakness,||
1122|108|S|unusual pain/swelling/discomfort, unusual/easy bruising,||
1122|109|S|prolonged bleeding from cuts or gums, unusually heavy/prolonged||
1122|110|S|menstrual flow, pink/dark urine, coughing up blood, vomit that is||
1122|111|S|bloody or looks like coffee grounds, severe headache,||
1122|112|S|dizziness/fainting, bloody/black/tarry stools.||
1122|113|S|   Get medical help right away if you have any signs of very||
1122|114|S|serious bleeding, including: vision changes, confusion, trouble||
1122|115|S|speaking, weakness on one side of the body.||
1122|116|S|   A very serious allergic reaction to this drug is rare.||
1122|117|S|However, get medical help right away if you notice any symptoms||
1122|118|S|of a serious allergic reaction, including: rash, itching/swelling||
1122|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1122|120|S|breathing.||
1122|121|S|   This is not a complete list of possible side effects. If you||
1122|122|S|notice other effects not listed above, contact your doctor or||
1122|123|S|pharmacist.||
1122|124|S|   In the US -||
1122|125|S|   Call your doctor for medical advice about side effects. You||
1122|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1122|127|S|www.fda.gov/medwatch.||
1122|128|S|   In Canada - Call your doctor for medical advice about side||
1122|129|S|effects. You may report side effects to Health Canada at||
1122|130|S|1-866-234-2345.||
1122|131|B|||
1122|132|P|PRECAUTIONS:  Before taking dabigatran, tell your doctor or||
1122|133|P|pharmacist if you are allergic to it; or if you have any other||
1122|134|P|allergies. This product may contain inactive ingredients, which||
1122|135|P|can cause allergic reactions or other problems. Talk to your||
1122|136|P|pharmacist for more details.||
1122|137|P|   Before using this medication, tell your doctor or pharmacist||
1122|138|P|your medical history, especially of: mechanical heart valve,||
1122|139|P|kidney disease, bleeding problems (such as bleeding of the||
1122|140|P|stomach/intestines, bleeding in the brain), blood disorders (such||
1122|141|P|as anemia, hemophilia, thrombocytopenia), liver disease, recent||
1122|142|P|major injury/surgery, stroke, a certain clotting disorder||
1122|143|P|(antiphospholipid syndrome), frequent falls/injuries.||
1122|144|P|   Before having surgery or any medical/dental procedures||
1122|145|P|(especially spinal puncture or spinal/epidural anesthesia), tell||
1122|146|P|your doctor or dentist that you are taking this medication and||
1122|147|P|about all the products you use (including prescription drugs,||
1122|148|P|nonprescription drugs, and herbal products). Your doctor or||
1122|149|P|dentist may tell you to stop taking dabigatran before your||
1122|150|P|surgery. Ask for specific instructions about stopping or starting||
1122|151|P|this medication.||
1122|152|P|   This medication may cause stomach bleeding. Daily use of||
1122|153|P|alcohol while using this medicine may increase your risk for||
1122|154|P|stomach bleeding. Limit alcoholic beverages. Ask your doctor or||
1122|155|P|pharmacist about how much alcohol you may safely drink.||
1122|156|P|   This medication can cause heavy bleeding. To lower the chance||
1122|157|P|of getting cut, bruised, or injured, use caution with sharp||
1122|158|P|objects like razors and nail cutters, and avoid activities such||
1122|159|P|as contact sports. Use an electric razor when shaving and a soft||
1122|160|P|toothbrush when brushing your teeth. If you fall or injure||
1122|161|P|yourself, especially if you hit your head, call your doctor right||
1122|162|P|away. Your doctor may need to check you.||
1122|163|P|   Older adults may be at greater risk for bleeding while using||
1122|164|P|this drug.||
1122|165|P|   During pregnancy, this medication should be used only when||
1122|166|P|clearly needed. Discuss the risks and benefits with your doctor.||
1122|167|P|   This medication passes into breast milk. Consult your doctor||
1122|168|P|before breastfeeding.||
1122|169|B|||
1122|170|I|DRUG INTERACTIONS:  See also Warning section.||
1122|171|I|   Drug interactions may change how your medications work or||
1122|172|I|increase your risk for serious side effects. This document does||
1122|173|I|not contain all possible drug interactions. Keep a list of all||
1122|174|I|the products you use (including prescription/nonprescription||
1122|175|I|drugs and herbal products) and share it with your doctor and||
1122|176|I|pharmacist. Do not start, stop, or change the dosage of any||
1122|177|I|medicines without your doctor's approval.||
1122|178|I|   Some products that may interact with this drug include:||
1122|179|I|mifepristone, other drugs that can cause bleeding/bruising||
1122|180|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
1122|181|I|ibuprofen/naproxen, "blood thinners" such as warfarin/apixaban).||
1122|182|I|   Aspirin can increase the risk of bleeding when used with this||
1122|183|I|medication. However, if your doctor has told you to take low-dose||
1122|184|I|aspirin to prevent heart attack or stroke (usually 81-162||
1122|185|I|milligrams a day), you should keep taking the aspirin unless your||
1122|186|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1122|187|I|details.||
1122|188|I|   Other medications can affect the removal of dabigatran from||
1122|189|I|your body, which may affect how dabigatran works. Examples||
1122|190|I|include apalutamide, cobicistat, cyclosporine, dronedarone,||
1122|191|I|ketoconazole, lorlatinib, rifampin, St. John's wort, drugs used||
1122|192|I|to treat seizures (such as carbamazepine, phenytoin), among||
1122|193|I|others.||
1122|194|B|||
1122|195|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1122|196|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1122|197|O|poison control center right away. US residents can call||
1122|198|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1122|199|O|Symptoms of overdose may include: bloody/black/tarry stools,||
1122|200|O|pink/dark urine, unusual/prolonged bleeding.||
1122|201|B|||
1122|202|N|NOTES:  Do not share this medication with others.||
1122|203|N|   Lab and/or medical tests (such as kidney/liver function,||
1122|204|N|clotting times) may be done while you are taking this medication.||
1122|205|N|Keep all medical and lab appointments. Consult your doctor for||
1122|206|N|more details.||
1122|207|B|||
1122|208|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1122|209|D|remember. If it is less than 6 hours before the next dose, skip||
1122|210|D|the missed dose. Take your next dose at the regular time. Do not||
1122|211|D|double the dose to catch up.||
1122|212|B|||
1122|213|R|STORAGE:  See also How to Use section.||
1122|214|R|   Store in the original bottle at room temperature away from||
1122|215|R|light and moisture. Do not store in the bathroom. Once the bottle||
1122|216|R|is opened, this medication expires after 4 months. If your||
1122|217|R|capsules are in a blister package, keep the medication in the||
1122|218|R|blister package until ready to use. Keep all medications away||
1122|219|R|from children and pets.||
1122|220|R|   Do not flush medications down the toilet or pour them into a||
1122|221|R|drain unless instructed to do so. Properly discard this product||
1122|222|R|when it is expired or no longer needed. Consult your pharmacist||
1122|223|R|or local waste disposal company.||
1122|224|B|||
1122|225|M|MEDICAL ALERT:  Your condition can cause complications in a||
1122|226|M|medical emergency. For information about enrolling in MedicAlert,||
1122|227|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1122|228|B|||
1122|229|A|Information last revised July 2025.||
1122|230|A|Copyright(c) 2025 First Databank, Inc.||
1122|231|B|||
1124|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1124|002|Z|does NOT have all possible information about this product. This||
1124|003|Z|information does not assure that this product is safe, effective,||
1124|004|Z|or appropriate for you. This information is not individual||
1124|005|Z|medical advice and does not substitute for the advice of your||
1124|006|Z|health care professional. Always ask your health care||
1124|007|Z|professional for complete information about this product and your||
1124|008|Z|specific health needs.||
1124|009|B|||
1124|010|T|NISOLDIPINE (10, 20, 30, OR 40 MG) SUSTAINED-ACTION - ORAL||
1124|011|F|(nye-SOL-di-peen)||
1124|012|B|||
1124|013|C|COMMON BRAND NAME(S): Sular||
1124|014|B|||
1124|015|U|USES:  Nisoldipine is used with or without other medications to||
1124|016|U|treat high blood pressure (hypertension). Lowering high blood||
1124|017|U|pressure helps prevent strokes, heart attacks, and kidney||
1124|018|U|problems. Nisoldipine is called a calcium channel blocker. It||
1124|019|U|works by relaxing blood vessels so blood can flow more easily.||
1124|020|B|||
1124|021|H|HOW TO USE:  Take this medication by mouth on an empty stomach or||
1124|022|H|with a low-fat meal as directed by your doctor, usually once||
1124|023|H|daily. Do not take within 1 hour before or 2 hours after a||
1124|024|H|high-fat meal. Doing so may increase side effects.||
1124|025|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1124|026|H|Doing so can release all of the drug at once, increasing the risk||
1124|027|H|of side effects.||
1124|028|H|   This medication comes in different sustained-action forms with||
1124|029|H|different strengths. Check with your doctor or pharmacist that||
1124|030|H|you are taking the correct dose and form. Do not take a different||
1124|031|H|strength or form without checking with your doctor or pharmacist||
1124|032|H|first.||
1124|033|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1124|034|H|using this medication unless your doctor or pharmacist says you||
1124|035|H|may do so safely. Grapefruit can increase the chance of side||
1124|036|H|effects with this medicine. Ask your doctor or pharmacist for||
1124|037|H|more details.||
1124|038|H|   The dosage is based on your medical condition and response to||
1124|039|H|treatment. Your doctor may gradually increase your dose. Follow||
1124|040|H|your doctor's instructions carefully.||
1124|041|H|   Use this medication regularly to get the most benefit from it.||
1124|042|H|To help you remember, take it at the same time each day. Keep||
1124|043|H|taking this medication even if you feel well. Most people with||
1124|044|H|high blood pressure do not feel sick.||
1124|045|H|   Tell your doctor if your condition does not get better or if||
1124|046|H|it gets worse (your blood pressure readings remain high or||
1124|047|H|increase).||
1124|048|B|||
1124|049|S|SIDE EFFECTS:  Dizziness, swelling ankles/feet, flushing, or||
1124|050|S|headache may occur. If any of these effects last or get worse,||
1124|051|S|tell your doctor or pharmacist promptly.||
1124|052|S|   To reduce the risk of dizziness and lightheadedness, get up||
1124|053|S|slowly when rising from a sitting or lying position.||
1124|054|S|   An empty tablet shell may appear in your stool. This effect is||
1124|055|S|harmless because your body has already absorbed the medication.||
1124|056|S|   Remember that this medication has been prescribed because your||
1124|057|S|doctor has judged that the benefit to you is greater than the||
1124|058|S|risk of side effects. Many people using this medication do not||
1124|059|S|have serious side effects.||
1124|060|S|   Tell your doctor right away if you have any serious side||
1124|061|S|effects, including: fast/irregular/pounding heartbeat, fainting,||
1124|062|S|vision changes.||
1124|063|S|   Some people who already have severe heart disease may rarely||
1124|064|S|develop worsening chest pain or a heart attack after starting||
1124|065|S|this medication or increasing the dose. Get medical help right||
1124|066|S|away if you experience: worsening chest pain, symptoms of a heart||
1124|067|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
1124|068|S|unusual sweating).||
1124|069|S|   A very serious allergic reaction to this drug is rare.||
1124|070|S|However, get medical help right away if you notice any symptoms||
1124|071|S|of a serious allergic reaction, including: rash, itching/swelling||
1124|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1124|073|S|breathing.||
1124|074|S|   This is not a complete list of possible side effects. If you||
1124|075|S|notice other effects not listed above, contact your doctor or||
1124|076|S|pharmacist.||
1124|077|S|   In the US -||
1124|078|S|   Call your doctor for medical advice about side effects. You||
1124|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1124|080|S|www.fda.gov/medwatch.||
1124|081|S|   In Canada - Call your doctor for medical advice about side||
1124|082|S|effects. You may report side effects to Health Canada at||
1124|083|S|1-866-234-2345.||
1124|084|B|||
1124|085|P|PRECAUTIONS:  Before taking nisoldipine, tell your doctor or||
1124|086|P|pharmacist if you are allergic to it; or to other dihydropyridine||
1124|087|P|calcium channel blockers (such as amlodipine, nifedipine); or if||
1124|088|P|you have any other allergies. This product may contain inactive||
1124|089|P|ingredients, which can cause allergic reactions or other||
1124|090|P|problems. Talk to your pharmacist for more details.||
1124|091|P|   Before using this medication, tell your doctor or pharmacist||
1124|092|P|your medical history, especially of: a certain structural heart||
1124|093|P|problem (aortic stenosis), liver disease.||
1124|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1124|095|P|can make you more dizzy. Do not drive, use machinery, or do||
1124|096|P|anything that needs alertness until you can do it safely. Limit||
1124|097|P|alcoholic beverages. Talk to your doctor if you are using||
1124|098|P|marijuana (cannabis).||
1124|099|P|   Before having surgery, tell your doctor or dentist about all||
1124|100|P|the products you use (including prescription drugs,||
1124|101|P|nonprescription drugs, and herbal products).||
1124|102|P|   During pregnancy, this medication should be used only when||
1124|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
1124|104|P|   It is unknown if this medication passes into breast milk.||
1124|105|P|Consult your doctor before breastfeeding.||
1124|106|B|||
1124|107|I|DRUG INTERACTIONS:  See also the How to Use section.||
1124|108|I|   Drug interactions may change how your medications work or||
1124|109|I|increase your risk for serious side effects. This document does||
1124|110|I|not contain all possible drug interactions. Keep a list of all||
1124|111|I|the products you use (including prescription/nonprescription||
1124|112|I|drugs and herbal products) and share it with your doctor and||
1124|113|I|pharmacist. Do not start, stop, or change the dosage of any||
1124|114|I|medicines without your doctor's approval.||
1124|115|I|   Other medications can affect the removal of nisoldipine from||
1124|116|I|your body, which may affect how nisoldipine works. Examples||
1124|117|I|include apalutamide, azole antifungals (such as itraconazole,||
1124|118|I|ketoconazole), cimetidine, enzalutamide, ivosidenib, macrolide||
1124|119|I|antibiotics (such as erythromycin), mitotane, rifamycins (such as||
1124|120|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
1124|121|I|as carbamazepine, phenytoin), among others.||
1124|122|I|   Some products have ingredients that could raise your heart||
1124|123|I|rate or blood pressure. Tell your pharmacist what products you||
1124|124|I|are using, and ask how to use them safely (especially||
1124|125|I|cough-and-cold products, diet aids, or NSAIDs such as||
1124|126|I|ibuprofen/naproxen).||
1124|127|B|||
1124|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1124|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1124|130|O|poison control center right away. US residents can call||
1124|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1124|132|B|||
1124|133|N|NOTES:  Do not share this medication with others. Talk with your||
1124|134|N|doctor about making lifestyle changes that may help this||
1124|135|N|medication work better (such as stress reduction programs,||
1124|136|N|exercise, and dietary changes).||
1124|137|N|   Lab and/or medical tests (such as liver function, heart exam,||
1124|138|N|blood pressure) may be done while you are taking this medication.||
1124|139|N|Keep all medical and lab appointments. Consult your doctor for||
1124|140|N|more details.||
1124|141|N|   Have your blood pressure checked regularly while taking this||
1124|142|N|medication. Learn how to monitor your own blood pressure at home,||
1124|143|N|and share the results with your doctor.||
1124|144|B|||
1124|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1124|146|D|remember. If it is near the time of the next dose, skip the||
1124|147|D|missed dose. Take your next dose at the regular time. Do not||
1124|148|D|double the dose to catch up.||
1124|149|B|||
1124|150|R|STORAGE:  Store at room temperature away from light and moisture.||
1124|151|R|Do not store in the bathroom. Keep all medications away from||
1124|152|R|children and pets.||
1124|153|R|   Do not flush medications down the toilet or pour them into a||
1124|154|R|drain unless instructed to do so. Properly discard this product||
1124|155|R|when it is expired or no longer needed. Consult your pharmacist||
1124|156|R|or local waste disposal company.||
1124|157|B|||
1124|158|A|Information last revised July 2025.||
1124|159|A|Copyright(c) 2025 First Databank, Inc.||
1124|160|B|||
1126|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1126|002|Z|does NOT have all possible information about this product. This||
1126|003|Z|information does not assure that this product is safe, effective,||
1126|004|Z|or appropriate for you. This information is not individual||
1126|005|Z|medical advice and does not substitute for the advice of your||
1126|006|Z|health care professional. Always ask your health care||
1126|007|Z|professional for complete information about this product and your||
1126|008|Z|specific health needs.||
1126|009|B|||
1126|010|T|DIFLUPREDNATE - OPHTHALMIC||
1126|011|F|(DYE-floo-PRED-nate)||
1126|012|B|||
1126|013|C|COMMON BRAND NAME(S): Durezol||
1126|014|B|||
1126|015|U|USES:  This medication is used to treat swelling and pain after||
1126|016|U|eye surgery. It may also be used to treat a certain serious eye||
1126|017|U|problem (endogenous anterior uveitis). This medication belongs to||
1126|018|U|a class of drugs known as corticosteroids.||
1126|019|B|||
1126|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1126|021|H|directed by your doctor, usually 4 times a day.||
1126|022|H|   To apply eye drops, wash your hands first. To avoid||
1126|023|H|contamination, do not touch the dropper tip or let it touch your||
1126|024|H|eye or any other surface.||
1126|025|H|   If you are wearing contact lenses, remove them before using||
1126|026|H|eye drops. Wait at least 10 minutes before replacing your contact||
1126|027|H|lenses.||
1126|028|H|   Tilt your head back, look upward, and pull down the lower||
1126|029|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1126|030|H|and place 1 drop into the pouch. Look downward and gently close||
1126|031|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
1126|032|H|your eye (near the nose) and apply gentle pressure. This will||
1126|033|H|prevent the medication from draining out. Try not to blink and do||
1126|034|H|not rub your eye. Repeat these steps for your other eye if so||
1126|035|H|directed or if your dose is for more than 1 drop.||
1126|036|H|   Do not rinse the dropper. Replace the dropper cap after each||
1126|037|H|use.||
1126|038|H|   Use this medication exactly as directed by your doctor. Your||
1126|039|H|doctor may direct you to use this medication more often at the||
1126|040|H|beginning of treatment and then reduce your dose gradually. Do||
1126|041|H|not stop using this medication without consulting your doctor.||
1126|042|H|Some conditions may become worse when the drug is suddenly||
1126|043|H|stopped.||
1126|044|H|   Wait several minutes for your vision to clear before driving||
1126|045|H|or operating machinery.||
1126|046|H|   Use this medication regularly to get the most benefit from it.||
1126|047|H|To help you remember, use it at the same time(s) each day. Keep||
1126|048|H|using it for the full time prescribed.||
1126|049|H|   If you are using another kind of eye medication (for example,||
1126|050|H|drops or ointments), wait at least 5 to 10 minutes before||
1126|051|H|applying other medications. Use eye drops before eye ointments to||
1126|052|H|allow the drops to enter the eye.||
1126|053|H|   Tell your doctor if your condition lasts or does not get||
1126|054|H|better.||
1126|055|B|||
1126|056|S|SIDE EFFECTS:  Temporary blurred vision may occur. If this effect||
1126|057|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
1126|058|S|   Remember that this medication has been prescribed because your||
1126|059|S|doctor has judged that the benefit to you is greater than the||
1126|060|S|risk of side effects. Many people using this medication do not||
1126|061|S|have serious side effects.||
1126|062|S|   Use of this medication for prolonged or repeated periods may||
1126|063|S|result in a new fungal infection. Do not use this medication for||
1126|064|S|longer than prescribed.||
1126|065|S|   Tell your doctor right away if you have any serious side||
1126|066|S|effects, including: new or increased eye||
1126|067|S|pain/swelling/discharge/redness, eye pain/discomfort in bright||
1126|068|S|light, vision changes.||
1126|069|S|   A very serious allergic reaction to this drug is rare.||
1126|070|S|However, get medical help right away if you notice any symptoms||
1126|071|S|of a serious allergic reaction, including: rash, itching/swelling||
1126|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1126|073|S|breathing.||
1126|074|S|   This is not a complete list of possible side effects. If you||
1126|075|S|notice other effects not listed above, contact your doctor or||
1126|076|S|pharmacist.||
1126|077|S|   In the US -||
1126|078|S|   Call your doctor for medical advice about side effects. You||
1126|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1126|080|S|www.fda.gov/medwatch.||
1126|081|S|   In Canada - Call your doctor for medical advice about side||
1126|082|S|effects. You may report side effects to Health Canada at||
1126|083|S|1-866-234-2345.||
1126|084|B|||
1126|085|P|PRECAUTIONS:  Before using difluprednate, tell your doctor or||
1126|086|P|pharmacist if you are allergic to it; or if you have any other||
1126|087|P|allergies. This product may contain inactive ingredients, which||
1126|088|P|can cause allergic reactions or other problems. Talk to your||
1126|089|P|pharmacist for more details.||
1126|090|P|   Before using this medication, tell your doctor or pharmacist||
1126|091|P|your medical history, especially of: current or past eye||
1126|092|P|infection (including viral infections such as herpes simplex||
1126|093|P|keratitis), cataracts, glaucoma.||
1126|094|P|   After you apply this drug, your vision may become temporarily||
1126|095|P|blurred. Do not drive, use machinery, or do anything that needs||
1126|096|P|clear vision until you can do it safely.||
1126|097|P|   During pregnancy, this medication should be used only when||
1126|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
1126|099|P|   It is unknown if difluprednate passes into breast milk.||
1126|100|P|Consult your doctor before breastfeeding.||
1126|101|B|||
1126|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1126|103|I|medications work or increase your risk for serious side effects.||
1126|104|I|This document does not contain all possible drug interactions.||
1126|105|I|Keep a list of all the products you use (including||
1126|106|I|prescription/nonprescription drugs and herbal products) and share||
1126|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1126|108|I|the dosage of any medicines without your doctor's approval.||
1126|109|B|||
1126|110|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1126|111|O|has overdosed and has serious symptoms such as passing out or||
1126|112|O|trouble breathing, call 911. Otherwise, call a poison control||
1126|113|O|center right away. US residents can call 1-800-222-1222. Canada||
1126|114|O|residents can call 1-844-764-7669.||
1126|115|B|||
1126|116|N|NOTES:  Do not share this medication with others.||
1126|117|N|   Lab and/or medical tests (such as intraocular pressure) may be||
1126|118|N|done while you are using this medication. Keep all medical and||
1126|119|N|lab appointments. Consult your doctor for more details.||
1126|120|B|||
1126|121|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1126|122|D|If it is near the time of the next dose, skip the missed dose.||
1126|123|D|Use your next dose at the regular time. Do not double the dose to||
1126|124|D|catch up.||
1126|125|B|||
1126|126|R|STORAGE:  Store at room temperature away from light. Keep all||
1126|127|R|medications away from children and pets.||
1126|128|R|   Do not flush medications down the toilet or pour them into a||
1126|129|R|drain unless instructed to do so. Properly discard this product||
1126|130|R|when it is expired or no longer needed. Consult your pharmacist||
1126|131|R|or local waste disposal company.||
1126|132|B|||
1126|133|A|Information last revised November 2024.||
1126|134|A|Copyright(c) 2025 First Databank, Inc.||
1126|135|B|||
1127|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1127|002|Z|does NOT have all possible information about this product. This||
1127|003|Z|information does not assure that this product is safe, effective,||
1127|004|Z|or appropriate for you. This information is not individual||
1127|005|Z|medical advice and does not substitute for the advice of your||
1127|006|Z|health care professional. Always ask your health care||
1127|007|Z|professional for complete information about this product and your||
1127|008|Z|specific health needs.||
1127|009|B|||
1127|010|T|MEASLES/MUMPS/RUBELLA/VARICELLA VACCINE - INJECTION||
1127|011|F|(MEE-zulz/mumps/roo-BEL-a/VAR-i-SEL-a)||
1127|012|B|||
1127|013|C|COMMON BRAND NAME(S): ProQuad||
1127|014|B|||
1127|015|U|USES:  This vaccine is used to help prevent measles (also known||
1127|016|U|as rubeola), mumps, rubella (also known as German measles), and||
1127|017|U|varicella (also known as chickenpox). These infections may cause||
1127|018|U|serious problems (such as deafness, lung/brain problems, harm to||
1127|019|U|an unborn baby). Vaccination is the best way to protect against||
1127|020|U|these life-threatening infections. This vaccine is usually given||
1127|021|U|to children between 12 months and 12 years old.||
1127|022|U|   This vaccine contains live viruses that have been weakened. It||
1127|023|U|works by increasing the body's natural defense (immunity) against||
1127|024|U|the viruses.||
1127|025|U|   Vaccines may not fully protect everyone who receives them.||
1127|026|B|||
1127|027|H|HOW TO USE:  Read all vaccine information available from your||
1127|028|H|health care professional before receiving the vaccine. If you||
1127|029|H|have any questions, ask your health care professional.||
1127|030|H|   This vaccine is given by injection by a health care||
1127|031|H|professional. Depending on the brand, it may be given either||
1127|032|H|under the skin or into the muscle of the upper arm.||
1127|033|H|   Vaccines are usually given in a series of doses to provide the||
1127|034|H|best protection. Closely follow the vaccination schedule provided||
1127|035|H|by the health care professional. To help you remember, mark your||
1127|036|H|calendar with a reminder.||
1127|037|H|   This vaccine may be given at the same time as other vaccines.||
1127|038|B|||
1127|039|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
1127|040|S|fever, or mild rash may occur. If any of these effects last or||
1127|041|S|get worse, tell the health care professional promptly.||
1127|042|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1127|043|S|vision changes, or ringing in the ears just after getting a||
1127|044|S|vaccine injection. Tell the health care professional right away||
1127|045|S|if your child has any of these symptoms. Sitting or lying down||
1127|046|S|may help, since these symptoms usually don't last long.||
1127|047|S|   Remember that this vaccine has been prescribed because the||
1127|048|S|health care professional has judged that the benefit to your||
1127|049|S|child is greater than the risk of side effects. Many people using||
1127|050|S|this vaccine do not have serious side effects.||
1127|051|S|   Tell the health care professional right away if your child has||
1127|052|S|any serious side effects, including: joint pain/stiffness, easy||
1127|053|S|bruising/bleeding, seizures, mental/mood changes (such as||
1127|054|S|confusion).||
1127|055|S|   A very serious allergic reaction to this vaccine is rare.||
1127|056|S|However, get medical help right away if you notice any symptoms||
1127|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1127|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1127|059|S|breathing.||
1127|060|S|   This is not a complete list of possible side effects. If you||
1127|061|S|notice other effects not listed above, contact the health care||
1127|062|S|professional.||
1127|063|S|   Contact the health care professional for medical advice about||
1127|064|S|side effects. The following numbers do not provide medical||
1127|065|S|advice, but in the US you may report side effects to the Vaccine||
1127|066|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1127|067|S|Canada, you may call the Vaccine Safety Section at Public Health||
1127|068|S|Agency of Canada at 1-866-844-0018.||
1127|069|B|||
1127|070|P|PRECAUTIONS:  Before your child receives this vaccine, tell the||
1127|071|P|health care professional if your child is allergic to it; or if||
1127|072|P|your child has any other allergies. This product may contain||
1127|073|P|inactive ingredients (such as neomycin), which can cause allergic||
1127|074|P|reactions or other problems. Talk to your health care||
1127|075|P|professional for more details.||
1127|076|P|   Before receiving this vaccine, tell the health care||
1127|077|P|professional your child's medical history, especially of: current||
1127|078|P|fever/illness (such as tuberculosis), immune system disorders||
1127|079|P|(such as due to HIV infection, certain cancers such as||
1127|080|P|leukemia/lymphoma, cancer or radiation treatment), bleeding/blood||
1127|081|P|clotting problems (such as hemophilia, low platelets), brain||
1127|082|P|disorders (such as seizures, head injury), blood/plasma||
1127|083|P|transfusions, vaccination history (including previous reactions||
1127|084|P|to any vaccines).||
1127|085|P|   There is a small risk that your child may expose others to||
1127|086|P|infection with chickenpox for up to 6 weeks after your child has||
1127|087|P|been vaccinated. If your child develops a rash after getting the||
1127|088|P|vaccine, your child should avoid being in the same room with||
1127|089|P|newborn babies (especially if born prematurely), pregnant women||
1127|090|P|who have not had chickenpox, and people with immune system||
1127|091|P|problems until the rash has dried and crusted over.||
1127|092|P|   Tell your health care professional if you are pregnant or plan||
1127|093|P|to become pregnant. This vaccine should not be given if you are||
1127|094|P|pregnant. It may harm an unborn baby. Avoid getting pregnant for||
1127|095|P|4 weeks after receiving this vaccine. Talk to your health care||
1127|096|P|professional for details.||
1127|097|P|   The rubella vaccine virus passes into breast milk. It is||
1127|098|P|unknown if the measles, mumps, or varicella vaccine virus passes||
1127|099|P|into breast milk. Consult your health care professional before||
1127|100|P|breastfeeding.||
1127|101|B|||
1127|102|I|DRUG INTERACTIONS:  Drug interactions may change how your child's||
1127|103|I|medications work or increase your child's risk for serious side||
1127|104|I|effects. This document does not contain all possible drug||
1127|105|I|interactions. Keep a list of all the products your child uses||
1127|106|I|(including prescription/nonprescription drugs and herbal||
1127|107|I|products) and share it with the health care professional. Do not||
1127|108|I|start, stop, or change the dosage of any medicines without your||
1127|109|I|child's doctor's approval.||
1127|110|I|   Some products that may interact with this vaccine are: drugs||
1127|111|I|that weaken the immune system (such as cyclosporine, tacrolimus,||
1127|112|I|cancer chemotherapy, corticosteroids such as prednisone), immune||
1127|113|I|globulin, certain antiviral drugs (such as acyclovir,||
1127|114|I|famciclovir, and valacyclovir).||
1127|115|I|   Avoid giving your child aspirin or aspirin-like medications||
1127|116|I|(such as salsalate) for 6 weeks after your child has been||
1127|117|I|vaccinated.||
1127|118|I|   This vaccine may interfere with certain lab tests (such as TB||
1127|119|I|skin test), possibly causing false test results. Make sure lab||
1127|120|I|personnel and all the doctors know that your child has recently||
1127|121|I|received this vaccine.||
1127|122|B|||
1127|123|O|OVERDOSE:  Not applicable.||
1127|124|B|||
1127|125|N|NOTES:  Keep all medical and lab appointments.||
1127|126|N|   Keep vaccine records for yourself and your children and||
1127|127|N|provide them to the health care professionals to prevent||
1127|128|N|unnecessary re-vaccinations.||
1127|129|B|||
1127|130|D|MISSED DOSE:  It is important that your child gets each||
1127|131|D|vaccination as scheduled. Ask when your child should get each||
1127|132|D|dose and mark your calendar with a reminder. If your child misses||
1127|133|D|a dose, call the health care professional to reschedule.||
1127|134|B|||
1127|135|R|STORAGE:  Different brands of this medication have different||
1127|136|R|storage needs. Check the product package for instructions on how||
1127|137|R|to store your brand, or ask your pharmacist. Protect from light.||
1127|138|R|Keep all medications away from children and pets.||
1127|139|R|   Do not flush medications down the toilet or pour them into a||
1127|140|R|drain unless instructed to do so. Properly discard this product||
1127|141|R|when it is expired or no longer needed. Consult your pharmacist||
1127|142|R|or local waste disposal company.||
1127|143|B|||
1127|144|A|Information last revised February 2025.||
1127|145|A|Copyright(c) 2025 First Databank, Inc.||
1127|146|B|||
1129|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1129|002|Z|does NOT have all possible information about this product. This||
1129|003|Z|information does not assure that this product is safe, effective,||
1129|004|Z|or appropriate for you. This information is not individual||
1129|005|Z|medical advice and does not substitute for the advice of your||
1129|006|Z|health care professional. Always ask your health care||
1129|007|Z|professional for complete information about this product and your||
1129|008|Z|specific health needs.||
1129|009|B|||
1129|010|T|ROMIPLOSTIM - INJECTION||
1129|011|F|(ROE-mi-PLOE-stim)||
1129|012|B|||
1129|013|C|COMMON BRAND NAME(S): Nplate||
1129|014|B|||
1129|015|U|USES:  This medication is used to treat a certain blood disorder||
1129|016|U|(idiopathic thrombocytopenia purpura - ITP) in which the blood||
1129|017|U|does not clot properly due to a lack of platelets. Platelets are||
1129|018|U|a type of blood cell needed to form blood clots and prevent||
1129|019|U|bleeding. Romiplostim decreases your risk of bleeding by||
1129|020|U|increasing the number of platelets. Romiplostim is also given to||
1129|021|U|people whose ability to make platelets is reduced due to exposure||
1129|022|U|to large amounts of radiation. Romiplostim acts like a certain||
1129|023|U|natural substance (thrombopoietin) that causes the body to||
1129|024|U|produce platelets.||
1129|025|B|||
1129|026|H|HOW TO USE:  Read the Medication Guide provided by your||
1129|027|H|pharmacist before you start using romiplostim and each time you||
1129|028|H|get a refill. If you have any questions, consult your doctor or||
1129|029|H|pharmacist.||
1129|030|H|   This medication is given by injection under the skin by a||
1129|031|H|health care professional. It is given as directed by your doctor,||
1129|032|H|usually once a week. The dosage is based on your medical||
1129|033|H|condition, weight, lab tests, and response to treatment.||
1129|034|H|   Your risk of bleeding may increase when you stop using||
1129|035|H|romiplostim. Your doctor should order weekly blood tests for at||
1129|036|H|least 2 weeks after your last dose. Tell your doctor right away||
1129|037|H|if you develop any bleeding/bruising.||
1129|038|H|   When used for an extended period, this medication may not work||
1129|039|H|as well and may require different dosing. Talk with your doctor||
1129|040|H|if this medication stops working well.||
1129|041|H|   Tell your doctor if your condition (bleeding/bruising) lasts||
1129|042|H|or gets worse.||
1129|043|B|||
1129|044|S|SIDE EFFECTS:  Headache, joint/muscle pain, dizziness, heartburn,||
1129|045|S|abdominal pain, tingling/numbness in hands/feet, and trouble||
1129|046|S|sleeping may occur. In children, fever, mouth/throat pain,||
1129|047|S|diarrhea, easy bruising, or swelling hands/ankles/feet may also||
1129|048|S|occur. If any of these effects last or get worse, tell your||
1129|049|S|doctor or pharmacist promptly.||
1129|050|S|   Remember that this medication has been prescribed because your||
1129|051|S|doctor has judged that the benefit to you is greater than the||
1129|052|S|risk of side effects. Many people using this medication do not||
1129|053|S|have serious side effects.||
1129|054|S|   This medication may rarely cause serious problems from blood||
1129|055|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1129|056|S|legs), especially if your platelet counts are too high. Keep all||
1129|057|S|medical/lab test appointments. Get medical help right away if you||
1129|058|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1129|059|S|pain, sudden dizziness/fainting, pain/swelling/warmth in the||
1129|060|S|groin/calf, trouble speaking, weakness on one side of the body,||
1129|061|S|sudden vision changes, confusion, unusual sweating, sudden/severe||
1129|062|S|headaches.||
1129|063|S|   A very serious allergic reaction to this drug is rare.||
1129|064|S|However, get medical help right away if you notice any symptoms||
1129|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1129|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1129|067|S|breathing.||
1129|068|S|   This is not a complete list of possible side effects. If you||
1129|069|S|notice other effects not listed above, contact your doctor or||
1129|070|S|pharmacist.||
1129|071|S|   In the US -||
1129|072|S|   Call your doctor for medical advice about side effects. You||
1129|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1129|074|S|www.fda.gov/medwatch.||
1129|075|S|   In Canada - Call your doctor for medical advice about side||
1129|076|S|effects. You may report side effects to Health Canada at||
1129|077|S|1-866-234-2345.||
1129|078|B|||
1129|079|P|PRECAUTIONS:  Before using romiplostim, tell your doctor or||
1129|080|P|pharmacist if you are allergic to it; or if you have any other||
1129|081|P|allergies. This product may contain inactive ingredients, which||
1129|082|P|can cause allergic reactions or other problems. Talk to your||
1129|083|P|pharmacist for more details.||
1129|084|P|   Before using this medication, tell your doctor or pharmacist||
1129|085|P|your medical history, especially of: blood clots, other blood||
1129|086|P|disorders (such as blood cancer, myelodysplastic syndrome), liver||
1129|087|P|disease.||
1129|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1129|089|P|can make you more dizzy. Do not drive, use machinery, or do||
1129|090|P|anything that needs alertness until you can do it safely. Limit||
1129|091|P|alcoholic beverages. Talk to your doctor if you are using||
1129|092|P|marijuana (cannabis).||
1129|093|P|   Before having surgery, tell your doctor or dentist about all||
1129|094|P|the products you use (including prescription drugs,||
1129|095|P|nonprescription drugs, and herbal products).||
1129|096|P|   During pregnancy, this medication should be used only when||
1129|097|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1129|098|P|benefits with your doctor.||
1129|099|P|   It is unknown if this drug passes into breast milk. Consult||
1129|100|P|your doctor before breastfeeding.||
1129|101|B|||
1129|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1129|103|I|medications work or increase your risk for serious side effects.||
1129|104|I|This document does not contain all possible drug interactions.||
1129|105|I|Keep a list of all the products you use (including||
1129|106|I|prescription/nonprescription drugs and herbal products) and share||
1129|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1129|108|I|the dosage of any medicines without your doctor's approval.||
1129|109|B|||
1129|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1129|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1129|112|O|poison control center right away. US residents can call||
1129|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1129|114|O|Symptoms of overdose may include: pain/swelling/warmth in the||
1129|115|O|groin/calf, sudden shortness of breath, coughing up blood, sudden||
1129|116|O|dizziness/fainting, chest/jaw/left arm pain, trouble speaking,||
1129|117|O|weakness on one side of the body, vision problems/changes.||
1129|118|B|||
1129|119|N|NOTES:  Lab and/or medical tests (such as blood and platelet||
1129|120|N|counts) should be done before you start using this medication and||
1129|121|N|while you are using it. Keep all medical and lab appointments.||
1129|122|N|Consult your doctor for more details.||
1129|123|B|||
1129|124|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
1129|125|D|right away for a new dosing schedule.||
1129|126|B|||
1129|127|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1129|128|R|doctor's office and will not be stored at home.||
1129|129|B|||
1129|130|M|MEDICAL ALERT:  Your condition can cause complications in a||
1129|131|M|medical emergency. For information about enrolling in MedicAlert,||
1129|132|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1129|133|B|||
1129|134|A|Information last revised July 2024.||
1129|135|A|Copyright(c) 2025 First Databank, Inc.||
1129|136|B|||
1130|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1130|002|Z|does NOT have all possible information about this product. This||
1130|003|Z|information does not assure that this product is safe, effective,||
1130|004|Z|or appropriate for you. This information is not individual||
1130|005|Z|medical advice and does not substitute for the advice of your||
1130|006|Z|health care professional. Always ask your health care||
1130|007|Z|professional for complete information about this product and your||
1130|008|Z|specific health needs.||
1130|009|B|||
1130|010|T|DECONGESTANT/ACETAMINOPHEN/ANTIHISTAMINE - ORAL||
1130|011|B|||
1130|012|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
1130|013|W|too much acetaminophen may cause serious (possibly fatal) liver||
1130|014|W|disease. Adults should not take more than 4000 milligrams (4||
1130|015|W|grams) of acetaminophen a day. People with liver problems and||
1130|016|W|children should take less acetaminophen. Ask your doctor or||
1130|017|W|pharmacist how much acetaminophen is safe to take.||
1130|018|W|   Do not use with any other drug containing acetaminophen||
1130|019|W|without asking your doctor or pharmacist first. Acetaminophen is||
1130|020|W|in many nonprescription and prescription medications (such as||
1130|021|W|pain/fever drugs or cough-and-cold products). Check the labels on||
1130|022|W|all your medicines to see if they contain acetaminophen, and ask||
1130|023|W|your pharmacist if you are unsure.||
1130|024|W|   Get medical help right away if you take too much acetaminophen||
1130|025|W|(overdose), even if you feel well. Overdose symptoms may include||
1130|026|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
1130|027|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
1130|028|W|   Daily alcohol use, especially when combined with||
1130|029|W|acetaminophen, may damage your liver. Avoid alcohol.||
1130|030|B|||
1130|031|U|USES:  This combination medication is used to temporarily treat||
1130|032|U|symptoms caused by the common cold, flu, allergies, or other||
1130|033|U|breathing illnesses (such as sinusitis, bronchitis).||
1130|034|U|Decongestants help relieve stuffy nose, sinus, and ear congestion||
1130|035|U|symptoms. Acetaminophen (APAP) is a non-aspirin pain reliever and||
1130|036|U|fever reducer. Antihistamines help relieve watery eyes, itchy||
1130|037|U|eyes/nose/throat, runny nose, and sneezing.||
1130|038|U|   Cough-and-cold products have not been shown to be safe or||
1130|039|U|effective in children younger than 6 years. Do not use this||
1130|040|U|product to treat cold symptoms in children younger than 6 years||
1130|041|U|unless specifically directed by the doctor. Some products (such||
1130|042|U|as long-acting tablets/capsules) are not recommended for use in||
1130|043|U|children younger than 12 years. Ask your doctor or pharmacist for||
1130|044|U|more details about using your product safely.||
1130|045|U|   These products do not cure or shorten the length of the common||
1130|046|U|cold and may cause serious side effects. To decrease the risk for||
1130|047|U|serious side effects, carefully follow all dosage directions. Do||
1130|048|U|not use this product to make a child sleepy. Do not give other||
1130|049|U|cough-and-cold medication that might contain the same or similar||
1130|050|U|ingredients (see also Drug Interactions section). Ask the doctor||
1130|051|U|or pharmacist about other ways to relieve cough and cold symptoms||
1130|052|U|(such as drinking enough fluids, using a humidifier or saline||
1130|053|U|nose drops/spray).||
1130|054|B|||
1130|055|H|HOW TO USE:  See also Warning section.||
1130|056|H|   If you are taking the over-the-counter product, read and||
1130|057|H|follow all directions on the package label. If your doctor has||
1130|058|H|prescribed this medication for you, take as directed by your||
1130|059|H|doctor. If you have any questions, consult your doctor or||
1130|060|H|pharmacist.||
1130|061|H|   Take this medication by mouth with or without food or as||
1130|062|H|directed by your doctor. If stomach upset occurs, it may help to||
1130|063|H|take this medication with food or milk. Drink plenty of fluids||
1130|064|H|when you use this medication unless otherwise directed by your||
1130|065|H|doctor. The fluid will help loosen the mucus in your lungs.||
1130|066|H|   If you are using the liquid form of this medication, carefully||
1130|067|H|measure the dose using a special measuring device/spoon. Do not||
1130|068|H|use a household spoon because you may not get the correct dose.||
1130|069|H|If your liquid form is a suspension, shake the bottle well before||
1130|070|H|each dose.||
1130|071|H|   If you are taking the extended-release capsules, swallow them||
1130|072|H|whole. Do not crush or chew extended-release capsules or tablets.||
1130|073|H|Doing so can release all of the drug at once, increasing the risk||
1130|074|H|of side effects. Also, do not split extended-release tablets||
1130|075|H|unless they have a score line and your doctor or pharmacist tells||
1130|076|H|you to do so. Swallow the whole or split tablet without crushing||
1130|077|H|or chewing.||
1130|078|H|   If you are taking the chewable form of this medication, chew||
1130|079|H|it thoroughly before swallowing.||
1130|080|H|   The dosage is based on your age, medical condition, and||
1130|081|H|response to treatment. Do not increase your dose, take it more||
1130|082|H|often, or use it for a longer time than directed. Do not give||
1130|083|H|children medicines labeled only for adults.||
1130|084|H|   Tell your doctor if your condition lasts for more than 1 week,||
1130|085|H|if it gets worse, or if it occurs with headache that doesn't go||
1130|086|H|away, rash, or fever lasting more than 3 days. These may be||
1130|087|H|symptoms of a serious medical problem and should be checked by a||
1130|088|H|doctor. Depending on the symptoms being treated, you may need to||
1130|089|H|contact your doctor earlier than 1 week, if they last or get||
1130|090|H|worse. Check your specific package label for when to contact your||
1130|091|H|doctor.||
1130|092|B|||
1130|093|S|SIDE EFFECTS:  See also Warning section.||
1130|094|S|   Drowsiness, dizziness, blurred vision, upset stomach, nausea,||
1130|095|S|nervousness, or dry mouth/nose/throat may occur. If any of these||
1130|096|S|effects last or get worse, tell your doctor or pharmacist||
1130|097|S|promptly.||
1130|098|S|   If your doctor has prescribed this medication, remember that||
1130|099|S|your doctor has judged that the benefit to you is greater than||
1130|100|S|the risk of side effects. Many people using this medication do||
1130|101|S|not have serious side effects.||
1130|102|S|   This medication may raise your blood pressure. Check your||
1130|103|S|blood pressure regularly and tell your doctor if the results are||
1130|104|S|high.||
1130|105|S|   Tell your doctor right away if you have any serious side||
1130|106|S|effects, including: mental/mood changes (such as confusion,||
1130|107|S|hallucinations), shaking, trouble urinating, fast/slow/irregular||
1130|108|S|heartbeat, seizure.||
1130|109|S|   A very serious allergic reaction to this drug is rare.||
1130|110|S|However, get medical help right away if you notice any symptoms||
1130|111|S|of a serious allergic reaction, including: rash, itching/swelling||
1130|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1130|113|S|breathing.||
1130|114|S|   This is not a complete list of possible side effects. If you||
1130|115|S|notice other effects not listed above, contact your doctor or||
1130|116|S|pharmacist.||
1130|117|S|   In the US -||
1130|118|S|   Call your doctor for medical advice about side effects. You||
1130|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1130|120|S|www.fda.gov/medwatch.||
1130|121|S|   In Canada - Call your doctor for medical advice about side||
1130|122|S|effects. You may report side effects to Health Canada at||
1130|123|S|1-866-234-2345.||
1130|124|B|||
1130|125|P|PRECAUTIONS:  See also Warning section.||
1130|126|P|   Before taking this product, tell your doctor or pharmacist if||
1130|127|P|you are allergic to any of its ingredients; or if you have any||
1130|128|P|other allergies. This product may contain inactive ingredients,||
1130|129|P|which can cause allergic reactions or other problems. Talk to||
1130|130|P|your pharmacist for more details.||
1130|131|P|   If you have any of the following health problems, consult your||
1130|132|P|doctor or pharmacist before using this medication: breathing||
1130|133|P|problems (such as asthma, emphysema), diabetes, glaucoma, heart||
1130|134|P|problems, high blood pressure, kidney problems, liver disease,||
1130|135|P|seizures, stomach/intestinal problems (such as blockage,||
1130|136|P|constipation, ulcers), overactive thyroid (hyperthyroidism),||
1130|137|P|urination problems (such as trouble urinating due to enlarged||
1130|138|P|prostate, urinary retention).||
1130|139|P|   This drug may make you dizzy or drowsy or blur your vision.||
1130|140|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1130|141|P|drowsy. Do not drive, use machinery, or do anything that needs||
1130|142|P|alertness or clear vision until you can do it safely. Avoid||
1130|143|P|alcoholic beverages. Talk to your doctor if you are using||
1130|144|P|marijuana (cannabis).||
1130|145|P|   Some brands of this product may contain sugar, alcohol, or||
1130|146|P|aspartame. Caution is advised if you have diabetes, alcohol||
1130|147|P|dependence, liver disease, phenylketonuria (PKU), or any other||
1130|148|P|condition that requires you to limit/avoid these substances in||
1130|149|P|your diet. Ask your doctor or pharmacist about using this product||
1130|150|P|safely.||
1130|151|P|   Before having surgery, tell your doctor or dentist about all||
1130|152|P|the products you use (including prescription drugs,||
1130|153|P|nonprescription drugs, and herbal products).||
1130|154|P|   Children may be more sensitive to the side effects of this||
1130|155|P|drug. In young children, antihistamines may cause||
1130|156|P|agitation/excitement instead of drowsiness.||
1130|157|P|   Older adults may be more sensitive to the side effects of this||
1130|158|P|drug, especially dizziness, drowsiness, confusion, constipation,||
1130|159|P|trouble urinating, fast/irregular heartbeat, or trouble sleeping.||
1130|160|P|Dizziness, drowsiness, trouble sleeping, and confusion can||
1130|161|P|increase the risk of falling.||
1130|162|P|   During pregnancy, this medication should be used only when||
1130|163|P|clearly needed. Discuss the risks and benefits with your doctor.||
1130|164|P|   This medication may pass into breast milk and may have||
1130|165|P|undesirable effects on a nursing infant. Consult your doctor||
1130|166|P|before breastfeeding.||
1130|167|B|||
1130|168|I|DRUG INTERACTIONS:  See also Warning section.||
1130|169|I|   Drug interactions may change how your medications work or||
1130|170|I|increase your risk for serious side effects. This document does||
1130|171|I|not contain all possible drug interactions. Keep a list of all||
1130|172|I|the products you use (including prescription/nonprescription||
1130|173|I|drugs and herbal products) and share it with your doctor and||
1130|174|I|pharmacist. Do not start, stop, or change the dosage of any||
1130|175|I|medicines without your doctor's approval.||
1130|176|I|   Some products that may interact with this drug are:||
1130|177|I|ketoconazole, levoketoconazole.||
1130|178|I|   Taking MAO inhibitors with this medication may cause a serious||
1130|179|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1130|180|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1130|181|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1130|182|I|selegiline, tranylcypromine) during treatment with this||
1130|183|I|medication. Most MAO inhibitors should also not be taken for two||
1130|184|I|weeks before treatment with this medication. Ask your doctor when||
1130|185|I|to start or stop taking this medication.||
1130|186|I|   Tell your doctor or pharmacist if you are taking other||
1130|187|I|products that cause drowsiness such as opioid pain or cough||
1130|188|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1130|189|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1130|190|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1130|191|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1130|192|I|diphenhydramine).||
1130|193|I|   The ingredients in this product are available in many||
1130|194|I|prescription and nonprescription products. Check the labels on||
1130|195|I|all your medicines (such as pain/fever drugs, diet aids, or||
1130|196|I|cough-and-cold/allergy products) because they may contain the||
1130|197|I|same or similar ingredients. Using these drugs along with this||
1130|198|I|product could increase side effects (such as fast heartbeat,||
1130|199|I|increased blood pressure, or drowsiness). Ask your pharmacist||
1130|200|I|about using those products safely.||
1130|201|I|   Do not use with any other antihistamines applied to the skin||
1130|202|I|(such as diphenhydramine cream, ointment, spray) because||
1130|203|I|increased side effects may occur.||
1130|204|I|   This medication may interfere with certain lab tests (such as||
1130|205|I|urine drug screening tests, urine 5-HIAA, allergy skin test),||
1130|206|I|possibly causing false test results. Make sure lab personnel and||
1130|207|I|all your doctors know you use this drug.||
1130|208|B|||
1130|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1130|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1130|211|O|poison control center right away. US residents can call||
1130|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1130|213|O|Symptoms of overdose may include: nausea, vomiting, loss of||
1130|214|O|appetite, sweating, stomach/abdominal pain, extreme tiredness,||
1130|215|O|agitation, confusion, flushing, hallucinations, yellowing||
1130|216|O|eyes/skin, dark urine, seizures. In children, excitement may||
1130|217|O|occur first, and may be followed by: loss of coordination,||
1130|218|O|drowsiness, loss of consciousness, seizures.||
1130|219|B|||
1130|220|N|NOTES:  Keep all medical and lab appointments.||
1130|221|B|||
1130|222|D|MISSED DOSE:  If you are taking this product on a regular||
1130|223|D|schedule and miss a dose, take it as soon as you remember. If it||
1130|224|D|is near the time of the next dose, skip the missed dose. Take||
1130|225|D|your next dose at the regular time. Do not double the dose to||
1130|226|D|catch up.||
1130|227|B|||
1130|228|R|STORAGE:  Store at room temperature away from light and moisture.||
1130|229|R|Do not store in the bathroom. Do not freeze liquid forms of this||
1130|230|R|medication. Keep all medications away from children and pets.||
1130|231|R|   Do not flush medications down the toilet or pour them into a||
1130|232|R|drain unless instructed to do so. Properly discard this product||
1130|233|R|when it is expired or no longer needed. Consult your pharmacist||
1130|234|R|or local waste disposal company.||
1130|235|B|||
1130|236|A|Information last revised July 2025.||
1130|237|A|Copyright(c) 2025 First Databank, Inc.||
1130|238|B|||
1131|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1131|002|Z|does NOT have all possible information about this product. This||
1131|003|Z|information does not assure that this product is safe, effective,||
1131|004|Z|or appropriate for you. This information is not individual||
1131|005|Z|medical advice and does not substitute for the advice of your||
1131|006|Z|health care professional. Always ask your health care||
1131|007|Z|professional for complete information about this product and your||
1131|008|Z|specific health needs.||
1131|009|B|||
1131|010|T|DECONGESTANT/ACETAMINOPHEN - ORAL||
1131|011|B|||
1131|012|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
1131|013|W|too much acetaminophen may cause serious (possibly fatal) liver||
1131|014|W|disease. Adults should not take more than 4000 milligrams (4||
1131|015|W|grams) of acetaminophen a day. People with liver problems and||
1131|016|W|children should take less acetaminophen. Ask your doctor or||
1131|017|W|pharmacist how much acetaminophen is safe to take.||
1131|018|W|   Do not use with any other drug containing acetaminophen||
1131|019|W|without asking your doctor or pharmacist first. Acetaminophen is||
1131|020|W|in many nonprescription and prescription medications (such as||
1131|021|W|pain/fever drugs or cough-and-cold products). Check the labels on||
1131|022|W|all your medicines to see if they contain acetaminophen, and ask||
1131|023|W|your pharmacist if you are unsure.||
1131|024|W|   Get medical help right away if you take too much acetaminophen||
1131|025|W|(overdose), even if you feel well. Overdose symptoms may include||
1131|026|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
1131|027|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine||
1131|028|W|   Daily alcohol use, especially when combined with||
1131|029|W|acetaminophen, may damage your liver. Avoid alcohol.||
1131|030|B|||
1131|031|U|USES:  This combination medication is used to temporarily treat||
1131|032|U|symptoms caused by the common cold, flu, allergies, or other||
1131|033|U|breathing illnesses (such as sinusitis, bronchitis).||
1131|034|U|Decongestants help relieve stuffy nose, sinus, and ear congestion||
1131|035|U|symptoms. Acetaminophen (APAP) is a non-aspirin pain reliever and||
1131|036|U|fever reducer.||
1131|037|U|   Cough-and-cold products have not been shown to be safe or||
1131|038|U|effective in children younger than 6 years. Do not use this||
1131|039|U|product to treat cold symptoms in children younger than 6 years||
1131|040|U|unless specifically directed by the doctor. Some products (such||
1131|041|U|as long-acting tablets/capsules) are not recommended for use in||
1131|042|U|children younger than 12 years. Ask your doctor or pharmacist for||
1131|043|U|more details about using your product safely.||
1131|044|U|   These products do not cure or shorten the length of the common||
1131|045|U|cold and may cause serious side effects. To decrease the risk for||
1131|046|U|serious side effects, carefully follow all dosage directions. Do||
1131|047|U|not use this product to make a child sleepy. Do not give other||
1131|048|U|cough-and-cold medication that might contain the same or similar||
1131|049|U|ingredients (see also Drug Interactions section). Ask the doctor||
1131|050|U|or pharmacist about other ways to relieve cough and cold symptoms||
1131|051|U|(such as drinking enough fluids, using a humidifier or saline||
1131|052|U|nose drops/spray).||
1131|053|B|||
1131|054|H|HOW TO USE:  See also Warning section.||
1131|055|H|   Read and follow all directions on the package label. Do not||
1131|056|H|give children medicines labeled only for adults. If you have any||
1131|057|H|questions, consult your pharmacist.||
1131|058|H|   Take this medication by mouth with or without food, usually||
1131|059|H|every 4 to 6 hours as needed or as directed by your doctor.||
1131|060|H|   If you are using the liquid form of this medication, carefully||
1131|061|H|measure the dose using a special measuring device/spoon. Do not||
1131|062|H|use a household spoon because you may not get the correct dose.||
1131|063|H|If your liquid form is a suspension, shake the bottle well before||
1131|064|H|each dose.||
1131|065|H|   The dosage is based on your age, medical condition, and||
1131|066|H|response to treatment. Do not increase your dose, take it more||
1131|067|H|often, or use it for a longer time than directed.||
1131|068|H|   Tell your doctor if your condition lasts for more than 1 week,||
1131|069|H|if it gets worse, or if it occurs with a headache that doesn't go||
1131|070|H|away, rash, or fever lasting more than 3 days. These may be||
1131|071|H|symptoms of a serious medical problem and should be checked by a||
1131|072|H|doctor.||
1131|073|B|||
1131|074|S|SIDE EFFECTS:  See also Warning section.||
1131|075|S|   Upset stomach, nausea, dizziness, trouble sleeping, or||
1131|076|S|nervousness may occur. If any of these effects last or get worse,||
1131|077|S|tell your doctor or pharmacist promptly.||
1131|078|S|   If your doctor has prescribed this medication, remember that||
1131|079|S|your doctor has judged that the benefit to you is greater than||
1131|080|S|the risk of side effects. Many people using this medication do||
1131|081|S|not have serious side effects.||
1131|082|S|   This medication may raise your blood pressure. Check your||
1131|083|S|blood pressure regularly and tell your doctor if the results are||
1131|084|S|high.||
1131|085|S|   Tell your doctor right away if you have any serious side||
1131|086|S|effects, including: mental/mood changes (such as confusion,||
1131|087|S|hallucinations), fast/irregular heartbeat, problems urinating.||
1131|088|S|   A very serious allergic reaction to this drug is rare.||
1131|089|S|However, get medical help right away if you notice any symptoms||
1131|090|S|of a serious allergic reaction, including: rash, itching/swelling||
1131|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1131|092|S|breathing.||
1131|093|S|   This is not a complete list of possible side effects. If you||
1131|094|S|notice other effects not listed above, contact your doctor or||
1131|095|S|pharmacist.||
1131|096|S|   In the US -||
1131|097|S|   Call your doctor for medical advice about side effects. You||
1131|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1131|099|S|www.fda.gov/medwatch.||
1131|100|S|   In Canada - Call your doctor for medical advice about side||
1131|101|S|effects. You may report side effects to Health Canada at||
1131|102|S|1-866-234-2345.||
1131|103|B|||
1131|104|P|PRECAUTIONS:  See also Warning section.||
1131|105|P|   Before taking this product, tell your doctor or pharmacist if||
1131|106|P|you are allergic to any of its ingredients; or if you have any||
1131|107|P|other allergies. This product may contain inactive ingredients,||
1131|108|P|which can cause allergic reactions or other problems. Talk to||
1131|109|P|your pharmacist for more details.||
1131|110|P|   If you have any of the following health problems, consult your||
1131|111|P|doctor or pharmacist before using this medication: breathing||
1131|112|P|problems (such as asthma, emphysema), diabetes, glaucoma, heart||
1131|113|P|problems, high blood pressure, liver disease, kidney problems,||
1131|114|P|overactive thyroid (hyperthyroidism), urination problems (such as||
1131|115|P|trouble urinating due to enlarged prostate, urinary retention).||
1131|116|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1131|117|P|can make you more dizzy. Do not drive, use machinery, or do||
1131|118|P|anything that needs alertness until you can do it safely. Avoid||
1131|119|P|alcoholic beverages. Talk to your doctor if you are using||
1131|120|P|marijuana (cannabis).||
1131|121|P|   Some brands of this product may contain sugar, alcohol, or||
1131|122|P|aspartame. Caution is advised if you have diabetes, alcohol||
1131|123|P|dependence, liver disease, phenylketonuria (PKU), or any other||
1131|124|P|condition that requires you to limit/avoid these substances in||
1131|125|P|your diet. Ask your doctor or pharmacist about using this product||
1131|126|P|safely.||
1131|127|P|   Before having surgery, tell your doctor or dentist about all||
1131|128|P|the products you use (including prescription drugs,||
1131|129|P|nonprescription drugs, and herbal products).||
1131|130|P|   Children may be more sensitive to the side effects of this||
1131|131|P|drug, especially excitation and agitation.||
1131|132|P|   Older adults may be more sensitive to the side effects of this||
1131|133|P|drug, especially fast/irregular heartbeat, dizziness, problems||
1131|134|P|urinating, trouble sleeping, or confusion.||
1131|135|P|   During pregnancy, this medication should be used only when||
1131|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
1131|137|P|   This medication may pass into breast milk. Consult your doctor||
1131|138|P|before breastfeeding.||
1131|139|B|||
1131|140|I|DRUG INTERACTIONS:  See also Warning section.||
1131|141|I|   Drug interactions may change how your medications work or||
1131|142|I|increase your risk for serious side effects. This document does||
1131|143|I|not contain all possible drug interactions. Keep a list of all||
1131|144|I|the products you use (including prescription/nonprescription||
1131|145|I|drugs and herbal products) and share it with your doctor and||
1131|146|I|pharmacist. Do not start, stop, or change the dosage of any||
1131|147|I|medicines without your doctor's approval.||
1131|148|I|   Some products that may interact with this drug are:||
1131|149|I|ketoconazole, levoketoconazole.||
1131|150|I|   Taking MAO inhibitors with this medication may cause a serious||
1131|151|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1131|152|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1131|153|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1131|154|I|selegiline, tranylcypromine) during treatment with this||
1131|155|I|medication. Most MAO inhibitors should also not be taken for two||
1131|156|I|weeks before treatment with this medication. Ask your doctor when||
1131|157|I|to start or stop taking this medication.||
1131|158|I|   The ingredients in this product are available in many||
1131|159|I|prescription and nonprescription products. Check the labels on||
1131|160|I|all your medicines (such as pain/fever drugs, diet aids, or||
1131|161|I|cold/allergy products) because they may contain the same or||
1131|162|I|similar ingredients. Using these drugs along with this product||
1131|163|I|could increase side effects (such as fast heartbeat or increased||
1131|164|I|blood pressure). Ask your pharmacist about using those products||
1131|165|I|safely.||
1131|166|I|   This medication may interfere with certain lab tests (such as||
1131|167|I|urine 5-HIAA), possibly causing false test results. Make sure lab||
1131|168|I|personnel and all your doctors know you use this drug.||
1131|169|B|||
1131|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1131|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1131|172|O|poison control center right away. US residents can call||
1131|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1131|174|O|Symptoms of overdose may include: fast/irregular heartbeat,||
1131|175|O|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
1131|176|O|pain, extreme tiredness, yellowing eyes/skin, dark urine,||
1131|177|O|hallucinations, seizures.||
1131|178|B|||
1131|179|N|NOTES:  Keep all medical and lab appointments.||
1131|180|B|||
1131|181|D|MISSED DOSE:  If you are taking this product on a regular||
1131|182|D|schedule and miss a dose, take it as soon as you remember. If it||
1131|183|D|is near the time of the next dose, skip the missed dose. Take||
1131|184|D|your next dose at the regular time. Do not double the dose to||
1131|185|D|catch up.||
1131|186|B|||
1131|187|R|STORAGE:  Store room temperature away from light and moisture. Do||
1131|188|R|not store in the bathroom. Do not freeze liquid forms of this||
1131|189|R|medication. Keep all medications away from children and pets.||
1131|190|R|   Do not flush medications down the toilet or pour them into a||
1131|191|R|drain unless instructed to do so. Properly discard this product||
1131|192|R|when it is expired or no longer needed. Consult your pharmacist||
1131|193|R|or local waste disposal company.||
1131|194|B|||
1131|195|A|Information last revised July 2025.||
1131|196|A|Copyright(c) 2025 First Databank, Inc.||
1131|197|B|||
1132|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1132|002|Z|does NOT have all possible information about this product. This||
1132|003|Z|information does not assure that this product is safe, effective,||
1132|004|Z|or appropriate for you. This information is not individual||
1132|005|Z|medical advice and does not substitute for the advice of your||
1132|006|Z|health care professional. Always ask your health care||
1132|007|Z|professional for complete information about this product and your||
1132|008|Z|specific health needs.||
1132|009|B|||
1132|010|T|NABILONE - ORAL||
1132|011|F|(NAB-i-lone)||
1132|012|B|||
1132|013|C|COMMON BRAND NAME(S): Cesamet||
1132|014|B|||
1132|015|U|USES:  This medication is used to treat severe nausea and||
1132|016|U|vomiting caused by cancer drug treatment (chemotherapy). Nabilone||
1132|017|U|is a man-made drug similar to the natural substances found in||
1132|018|U|marijuana (cannabis). It is works by decreasing the signals in||
1132|019|U|the brain that lead to nausea and vomiting.||
1132|020|B|||
1132|021|H|HOW TO USE:  See also Side Effects section.||
1132|022|H|   Read the Patient Information Leaflet if available from your||
1132|023|H|pharmacist before you start taking nabilone and each time you get||
1132|024|H|a refill. If you have any questions, ask your doctor or||
1132|025|H|pharmacist.||
1132|026|H|   Take this medication by mouth as directed by your doctor,||
1132|027|H|usually 2 to 3 times a day. The first dose may be taken the night||
1132|028|H|before chemotherapy treatment. On the day you start chemotherapy,||
1132|029|H|take nabilone 1 to 3 hours before chemotherapy begins. Continue||
1132|030|H|to take this medication as directed by your doctor throughout||
1132|031|H|your chemotherapy treatment cycle. Your doctor may also direct||
1132|032|H|you to keep taking this medication until 24 to 48 hours after||
1132|033|H|your treatment cycle ends. Follow your doctor's instructions||
1132|034|H|carefully.||
1132|035|H|   The dosage is based on your medical condition and response to||
1132|036|H|treatment.||
1132|037|H|   Use this medication regularly throughout your treatment cycle||
1132|038|H|to get the most benefit from it. To help you remember, take it at||
1132|039|H|the same times each day. This medication should not be taken on||
1132|040|H|an "as needed" basis.||
1132|041|H|   Do not increase your dose or use this drug more often or for||
1132|042|H|longer than prescribed. Your condition will not improve any||
1132|043|H|faster, and your risk of side effects will increase.||
1132|044|H|   If you suddenly stop using this medication, you may have||
1132|045|H|withdrawal symptoms (such as irritability, trouble sleeping,||
1132|046|H|sweating, and diarrhea). To help prevent withdrawal, your doctor||
1132|047|H|may lower your dose slowly. Withdrawal is more likely if you have||
1132|048|H|used nabilone for a long time or in high doses. Tell your doctor||
1132|049|H|or pharmacist right away if you have withdrawal.||
1132|050|H|   Though it helps many people, this medication may sometimes||
1132|051|H|cause addiction. This risk may be higher if you have a substance||
1132|052|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1132|053|H|Take this medication exactly as prescribed to lower the risk of||
1132|054|H|addiction. Ask your doctor or pharmacist for more details.||
1132|055|H|   Tell your doctor if your condition lasts or gets worse.||
1132|056|B|||
1132|057|S|SIDE EFFECTS:  Dizziness, drowsiness, dry mouth, feeling "high,"||
1132|058|S|an exaggerated sense of well-being (euphoria), lightheadedness,||
1132|059|S|headache, trouble sleeping, or memory problems may occur. If any||
1132|060|S|of these effects last or get worse, tell your doctor or||
1132|061|S|pharmacist promptly.||
1132|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
1132|063|S|slowly when rising from a sitting or lying position.||
1132|064|S|   People using this medication may have serious side effects.||
1132|065|S|However, you have been prescribed this drug because your doctor||
1132|066|S|has judged that the benefit to you is greater than the risk of||
1132|067|S|side effects. Careful monitoring by your doctor may decrease your||
1132|068|S|risk.||
1132|069|S|   Tell your doctor right away if you have any serious side||
1132|070|S|effects, including: fainting, unusual weakness, vision changes,||
1132|071|S|mental/mood changes (such as depression, anxiety, panic,||
1132|072|S|paranoia, hallucinations, psychosis).||
1132|073|S|   Because nabilone can cause mental, mood, or behavior changes,||
1132|074|S|a responsible caretaker should closely supervise you while you||
1132|075|S|are taking this medication. If you have any such effects, remain||
1132|076|S|calm and tell your doctor right away. Do not take any more||
1132|077|S|nabilone until after you consult with your doctor.||
1132|078|S|   Get medical help right away if you have any very serious side||
1132|079|S|effects, including: fast heartbeat, seizures.||
1132|080|S|   A very serious allergic reaction to this drug is rare.||
1132|081|S|However, get medical help right away if you notice any symptoms||
1132|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1132|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1132|084|S|breathing.||
1132|085|S|   This is not a complete list of possible side effects. If you||
1132|086|S|notice other effects not listed above, contact your doctor or||
1132|087|S|pharmacist.||
1132|088|S|   In the US -||
1132|089|S|   Call your doctor for medical advice about side effects. You||
1132|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1132|091|S|www.fda.gov/medwatch.||
1132|092|S|   In Canada - Call your doctor for medical advice about side||
1132|093|S|effects. You may report side effects to Health Canada at||
1132|094|S|1-866-234-2345.||
1132|095|B|||
1132|096|P|PRECAUTIONS:  Before taking nabilone, tell your doctor or||
1132|097|P|pharmacist if you are allergic to it; or to marijuana (cannabis)||
1132|098|P|or related products; or if you have any other allergies. This||
1132|099|P|product may contain inactive ingredients, which can cause||
1132|100|P|allergic reactions or other problems. Talk to your pharmacist for||
1132|101|P|more details.||
1132|102|P|   Before using this medication, tell your doctor or pharmacist||
1132|103|P|your medical history, especially of: liver disease, high blood||
1132|104|P|pressure, heart disease, mental/mood conditions (such as mania,||
1132|105|P|depression, schizophrenia), personal or family history of a||
1132|106|P|substance use disorder (such as overuse of or addiction to||
1132|107|P|drugs/alcohol).||
1132|108|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1132|109|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1132|110|P|machinery, or do anything that needs alertness until you can do||
1132|111|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1132|112|P|are using marijuana (cannabis).||
1132|113|P|   Before having surgery, tell your doctor or dentist about all||
1132|114|P|the products you use (including prescription drugs,||
1132|115|P|nonprescription drugs, and herbal products).||
1132|116|P|   Children may be more sensitive to the side effects of this||
1132|117|P|drug, especially mental/mood changes.||
1132|118|P|   Older adults may be more sensitive to the side effects of this||
1132|119|P|drug, especially dizziness, lightheadedness, and mental/mood||
1132|120|P|changes.||
1132|121|P|   Tell your doctor if you are pregnant or plan to become||
1132|122|P|pregnant. You should not become pregnant while using nabilone.||
1132|123|P|Nabilone may harm an unborn baby. If you become pregnant, talk to||
1132|124|P|your doctor right away about the risks and benefits of this||
1132|125|P|medication.||
1132|126|P|   It is unknown if this medication passes into breast milk.||
1132|127|P|However, similar drugs pass into breast milk and may have||
1132|128|P|undesirable effects on a nursing infant. Breastfeeding is not||
1132|129|P|recommended while using this medication. Consult your doctor||
1132|130|P|before breastfeeding.||
1132|131|B|||
1132|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1132|133|I|medications work or increase your risk for serious side effects.||
1132|134|I|This document does not contain all possible drug interactions.||
1132|135|I|Keep a list of all the products you use (including||
1132|136|I|prescription/nonprescription drugs and herbal products) and share||
1132|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
1132|138|I|the dosage of any medicines without your doctor's approval.||
1132|139|I|   Tell your doctor or pharmacist if you are taking other||
1132|140|I|products that cause drowsiness including alcohol, marijuana||
1132|141|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1132|142|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1132|143|I|zolpidem), muscle relaxants (such as carisoprodol,||
1132|144|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
1132|145|I|hydrocodone).||
1132|146|I|   Check the labels on all your medicines (such as allergy or||
1132|147|I|cough-and-cold products) because they may contain ingredients||
1132|148|I|that cause drowsiness. Ask your pharmacist about using those||
1132|149|I|products safely.||
1132|150|B|||
1132|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1132|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1132|153|O|poison control center right away. US residents can call||
1132|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1132|155|O|Symptoms of overdose may include: fast heartbeat, severe||
1132|156|O|dizziness, hallucinations, anxiety, difficulty breathing, loss of||
1132|157|O|consciousness.||
1132|158|B|||
1132|159|N|NOTES:  Do not share this medication with others. Sharing it is||
1132|160|N|against the law.||
1132|161|B|||
1132|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1132|163|D|remember. If it is near the time of the next dose, skip the||
1132|164|D|missed dose. Take your next dose at the regular time. Do not||
1132|165|D|double the dose to catch up.||
1132|166|B|||
1132|167|R|STORAGE:  Store at room temperature away from light and moisture.||
1132|168|R|Do not store in the bathroom. Keep all medications away from||
1132|169|R|children and pets.||
1132|170|R|   Do not flush medications down the toilet or pour them into a||
1132|171|R|drain unless instructed to do so. Properly discard this product||
1132|172|R|when it is expired or no longer needed. Consult your pharmacist||
1132|173|R|or local waste disposal company.||
1132|174|B|||
1132|175|A|Information last revised May 2024.||
1132|176|A|Copyright(c) 2025 First Databank, Inc.||
1132|177|B|||
1133|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1133|002|Z|does NOT have all possible information about this product. This||
1133|003|Z|information does not assure that this product is safe, effective,||
1133|004|Z|or appropriate for you. This information is not individual||
1133|005|Z|medical advice and does not substitute for the advice of your||
1133|006|Z|health care professional. Always ask your health care||
1133|007|Z|professional for complete information about this product and your||
1133|008|Z|specific health needs.||
1133|009|B|||
1133|010|T|PACLITAXEL - INJECTION||
1133|011|F|(pack-lih-TAX-el)||
1133|012|B|||
1133|013|C|COMMON BRAND NAME(S): Onxol, Taxol||
1133|014|B|||
1133|015|W|WARNING:  Paclitaxel may rarely cause serious (rarely fatal)||
1133|016|W|allergic reactions. Patients who experience a severe allergic||
1133|017|W|reaction with this drug must never use it again. Your doctor may||
1133|018|W|prescribe other medications (such as antihistamines,||
1133|019|W|corticosteroids) to help prevent an allergic reaction. However,||
1133|020|W|severe allergic reactions may still occur in a few patients. Get||
1133|021|W|medical help right away if you develop any signs of an allergic||
1133|022|W|reaction such as rash, itching, swelling, severe dizziness,||
1133|023|W|trouble breathing, or chest pain.||
1133|024|W|   This medication may often cause a serious blood disorder||
1133|025|W|(decreased bone marrow function leading to a low number of white||
1133|026|W|blood cells). This effect can lower your body's ability to fight||
1133|027|W|an infection. Your doctor will monitor you closely and check your||
1133|028|W|blood often during treatment. If your white blood cell count is||
1133|029|W|too low, you should not receive this medication. Tell your doctor||
1133|030|W|right away if you develop any signs of infection (such as sore||
1133|031|W|throat that doesn't go away, fever, chills, painful/difficult||
1133|032|W|urination).||
1133|033|B|||
1133|034|U|USES:  Paclitaxel is used to treat various types of cancer. It is||
1133|035|U|a cancer chemotherapy drug that works by slowing or stopping||
1133|036|U|cancer cell growth.||
1133|037|B|||
1133|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1133|039|H|from your pharmacist before you start using paclitaxel and each||
1133|040|H|time you receive a dose. If you have any questions, ask your||
1133|041|H|doctor or pharmacist.||
1133|042|H|   This medication is given by injection into a vein by a health||
1133|043|H|care professional. It is given on a schedule as directed by your||
1133|044|H|doctor. The dosage is based on your medical condition, body size,||
1133|045|H|and response to treatment.||
1133|046|B|||
1133|047|S|SIDE EFFECTS:  See also Warning section.||
1133|048|S|   Nausea, vomiting, diarrhea, mouth sores, muscle/joint pain,||
1133|049|S|numbness/tingling/burning of the hands/feet, flushing, dizziness,||
1133|050|S|or drowsiness may occur. If any of these effects last or get||
1133|051|S|worse, tell your doctor promptly.||
1133|052|S|   Temporary hair loss may occur. Normal hair growth should||
1133|053|S|return after treatment has ended.||
1133|054|S|   This medication may rarely cause changes to your blood||
1133|055|S|pressure and heart rate. You should be closely monitored for||
1133|056|S|these changes during the infusion of this medication. Tell your||
1133|057|S|doctor promptly if you have increasing dizziness, headache, or a||
1133|058|S|fast/slow/irregular heartbeat.||
1133|059|S|   People using this medication may have serious side effects.||
1133|060|S|However, you have been prescribed this drug because your doctor||
1133|061|S|has judged that the benefit to you is greater than the risk of||
1133|062|S|side effects. Careful monitoring by your doctor may decrease your||
1133|063|S|risk.||
1133|064|S|   Tell your doctor right away if you have any serious side||
1133|065|S|effects, including: nausea/vomiting that doesn't stop, signs of||
1133|066|S|anemia (such as unusual tiredness, pale skin), easy||
1133|067|S|bruising/bleeding, fainting, confusion,||
1133|068|S|pain/redness/swelling/weakness of the arms/legs, calf||
1133|069|S|pain/swelling that is warm to the touch, coughing up blood,||
1133|070|S|stomach/abdominal pain, yellowing eyes/skin, dark urine,||
1133|071|S|vision/hearing changes, seizures.||
1133|072|S|   This medication may rarely irritate the vein it is given into||
1133|073|S|or leak out of the vein and irritate the area. These effects may||
1133|074|S|cause redness, pain, swelling, discoloration, or unusual skin||
1133|075|S|reactions at the injection site, either while the drug is given||
1133|076|S|or rarely 7 to 10 days later. If this drug has leaked out of a||
1133|077|S|vein and caused a skin reaction in the past, you may rarely have||
1133|078|S|a skin reaction in that same area when the drug is given again,||
1133|079|S|even when it is given into another area. Tell your doctor right||
1133|080|S|away of any unusual skin/injection site symptoms.||
1133|081|S|   This is not a complete list of possible side effects. If you||
1133|082|S|notice other effects not listed above, contact your doctor or||
1133|083|S|pharmacist.||
1133|084|S|   In the US -||
1133|085|S|   Call your doctor for medical advice about side effects. You||
1133|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1133|087|S|www.fda.gov/medwatch.||
1133|088|S|   In Canada - Call your doctor for medical advice about side||
1133|089|S|effects. You may report side effects to Health Canada at||
1133|090|S|1-866-234-2345.||
1133|091|B|||
1133|092|P|PRECAUTIONS:  Before using paclitaxel, tell your doctor or||
1133|093|P|pharmacist if you are allergic to it; or to similar drugs||
1133|094|P|(taxane-type drugs such as docetaxel, cabazitaxel); or if you||
1133|095|P|have any other allergies. This product may contain inactive||
1133|096|P|ingredients (such as polyoxyethylated castor oil), which can||
1133|097|P|cause allergic reactions or other problems. Talk to your||
1133|098|P|pharmacist for more details.||
1133|099|P|   Before using this medication, tell your doctor or pharmacist||
1133|100|P|your medical history, especially of: blood disorders (such as low||
1133|101|P|white blood cell count), decreased bone marrow function, current||
1133|102|P|infections, heart problems (such as fast/slow/irregular||
1133|103|P|heartbeat), high or low blood pressure, liver disease.||
1133|104|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1133|105|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1133|106|P|machinery, or do anything that needs alertness until you can do||
1133|107|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1133|108|P|are using marijuana (cannabis).||
1133|109|P|   Tell your health care professional that you are using||
1133|110|P|paclitaxel before having any immunizations/vaccinations. Avoid||
1133|111|P|contact with people who have recently received live vaccines||
1133|112|P|(such as flu vaccine inhaled through the nose).||
1133|113|P|   Paclitaxel can make you more likely to get infections or may||
1133|114|P|make current infections worse. Stay away from anyone who has an||
1133|115|P|infection that may easily spread (such as chickenpox, COVID-19,||
1133|116|P|measles, flu). Talk to your doctor if you have been exposed to an||
1133|117|P|infection or for more details.||
1133|118|P|   To lower the chance of getting cut, bruised, or injured, use||
1133|119|P|caution with sharp objects like safety razors and nail cutters,||
1133|120|P|and avoid activities such as contact sports.||
1133|121|P|   Before having surgery, tell your doctor or dentist about all||
1133|122|P|the products you use (including prescription drugs,||
1133|123|P|nonprescription drugs, and herbal products).||
1133|124|P|   This product contains alcohol. Children may be more sensitive||
1133|125|P|to the side effects of alcohol, especially drowsiness and||
1133|126|P|confusion.||
1133|127|P|   Older adults may be more sensitive to the side effects of this||
1133|128|P|drug, especially the decrease in bone marrow function and||
1133|129|P|numbness/tingling/burning of the hands/feet.||
1133|130|P|   Tell your doctor if you are pregnant or plan to become||
1133|131|P|pregnant. You should not become pregnant while using paclitaxel.||
1133|132|P|Paclitaxel may harm an unborn baby. Your doctor should order a||
1133|133|P|pregnancy test before you start this medication. Men and women||
1133|134|P|using this medication should ask about reliable forms of birth||
1133|135|P|control during treatment and for some time afterwards. If you or||
1133|136|P|your partner becomes pregnant, talk to your doctor right away||
1133|137|P|about the risks and benefits of this medication.||
1133|138|P|   It is unknown if this drug passes into breast milk. Because of||
1133|139|P|the possible risk to the infant, breastfeeding is not recommended||
1133|140|P|while using this drug. Consult your doctor before breastfeeding.||
1133|141|B|||
1133|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1133|143|I|medications work or increase your risk for serious side effects.||
1133|144|I|This document does not contain all possible drug interactions.||
1133|145|I|Keep a list of all the products you use (including||
1133|146|I|prescription/nonprescription drugs and herbal products) and share||
1133|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
1133|148|I|the dosage of any medicines without your doctor's approval.||
1133|149|I|   Tell your doctor or pharmacist if you are taking other||
1133|150|I|products that cause drowsiness such as opioid pain or cough||
1133|151|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1133|152|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1133|153|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1133|154|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1133|155|I|diphenhydramine).||
1133|156|I|   Check the labels on all your medicines (such as allergy or||
1133|157|I|cough-and-cold products) because they may contain ingredients||
1133|158|I|that cause drowsiness. Ask your pharmacist about using those||
1133|159|I|products safely.||
1133|160|B|||
1133|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1133|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1133|163|O|poison control center right away. US residents can call||
1133|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1133|165|B|||
1133|166|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
1133|167|N|should be done while you are using this medication. Keep all||
1133|168|N|medical and lab appointments. Consult your doctor for more||
1133|169|N|details.||
1133|170|B|||
1133|171|D|MISSED DOSE:  It is important to get each dose of this medication||
1133|172|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1133|173|D|right away for a new dosing schedule.||
1133|174|B|||
1133|175|R|STORAGE:  Not applicable. This medication is given in a clinic||
1133|176|R|and will not be stored at home.||
1133|177|B|||
1133|178|M|MEDICAL ALERT:  Your condition can cause complications in a||
1133|179|M|medical emergency. For information about enrolling in MedicAlert,||
1133|180|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1133|181|B|||
1133|182|A|Information last revised April 2025.||
1133|183|A|Copyright(c) 2025 First Databank, Inc.||
1133|184|B|||
1134|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1134|002|Z|does NOT have all possible information about this product. This||
1134|003|Z|information does not assure that this product is safe, effective,||
1134|004|Z|or appropriate for you. This information is not individual||
1134|005|Z|medical advice and does not substitute for the advice of your||
1134|006|Z|health care professional. Always ask your health care||
1134|007|Z|professional for complete information about this product and your||
1134|008|Z|specific health needs.||
1134|009|B|||
1134|010|T|PEGASPARGASE - INJECTION||
1134|011|F|(peg-ASP-are-gace)||
1134|012|B|||
1134|013|C|COMMON BRAND NAME(S): Oncaspar||
1134|014|B|||
1134|015|U|USES:  This medication is usually used to treat acute lymphocytic||
1134|016|U|leukemia (ALL), especially in patients who are allergic to||
1134|017|U|L-asparaginase. It works by starving tumor cells of a certain||
1134|018|U|amino acid (asparagine), causing the tumor cells to die.||
1134|019|B|||
1134|020|H|HOW TO USE:  This medication is given by injection into a vein or||
1134|021|H|a muscle by a health care professional. The dosage is based on||
1134|022|H|your body size and response to treatment.||
1134|023|H|   To help prevent side effects (infusion and allergic||
1134|024|H|reactions), your doctor may direct you to use other medications||
1134|025|H|before you receive this medication. Use these additional||
1134|026|H|medications exactly as directed by your doctor.||
1134|027|B|||
1134|028|S|SIDE EFFECTS:  Nausea, vomiting, weakness, diarrhea, or||
1134|029|S|pain/swelling/redness at injection site may occur. If any of||
1134|030|S|these effects last or get worse, tell your doctor or pharmacist||
1134|031|S|promptly.||
1134|032|S|   Remember that this medication has been prescribed because your||
1134|033|S|doctor has judged that the benefit to you is greater than the||
1134|034|S|risk of side effects. Many people using this medication do not||
1134|035|S|have serious side effects.||
1134|036|S|   Tell your doctor right away if you have any serious side||
1134|037|S|effects, including: severe stomach/abdominal pain, swelling of||
1134|038|S|the stomach/abdomen, signs of liver disease (such as||
1134|039|S|nausea/vomiting that doesn't stop, loss of appetite, yellowing||
1134|040|S|eyes/skin, dark urine), signs of infection (such as sore throat||
1134|041|S|that doesn't go away, fever, chills), increased thirst/urination,||
1134|042|S|easy bruising/bleeding, pain/redness/swelling/numbness/tingling||
1134|043|S|of the arms or legs.||
1134|044|S|   Get medical help right away if you have any very serious side||
1134|045|S|effects, including: sudden shortness of breath, chest pain,||
1134|046|S|severe headache, seizures, trouble speaking, confusion, vision||
1134|047|S|changes, weakness on one side of the body.||
1134|048|S|   A very serious allergic reaction to this drug is rare.||
1134|049|S|However, get medical help right away if you notice any symptoms||
1134|050|S|of a serious allergic reaction, including: rash, itching/swelling||
1134|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1134|052|S|breathing.||
1134|053|S|   This is not a complete list of possible side effects. If you||
1134|054|S|notice other effects not listed above, contact your doctor or||
1134|055|S|pharmacist.||
1134|056|S|   In the US -||
1134|057|S|   Call your doctor for medical advice about side effects. You||
1134|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1134|059|S|www.fda.gov/medwatch.||
1134|060|S|   In Canada - Call your doctor for medical advice about side||
1134|061|S|effects. You may report side effects to Health Canada at||
1134|062|S|1-866-234-2345.||
1134|063|B|||
1134|064|P|PRECAUTIONS:  Before using pegaspargase, tell your doctor or||
1134|065|P|pharmacist if you are allergic to it; or to L-asparaginase; or if||
1134|066|P|you have any other allergies. This product may contain inactive||
1134|067|P|ingredients, which can cause allergic reactions or other||
1134|068|P|problems. Talk to your pharmacist for more details.||
1134|069|P|   Before using this medication, tell your doctor or pharmacist||
1134|070|P|your medical history, especially of: history of a serious||
1134|071|P|reaction to L-asparaginase (such as bleeding, blood clots,||
1134|072|P|pancreatitis), diabetes, clotting/bleeding disorders, liver||
1134|073|P|disease, pancreatitis.||
1134|074|P|   Do not have immunizations/vaccinations without the consent of||
1134|075|P|your doctor, and avoid contact with people who have recently||
1134|076|P|received oral polio vaccine or flu vaccine inhaled through the||
1134|077|P|nose.||
1134|078|P|   Wash your hands well to prevent the spread of infections.||
1134|079|P|   To lower your risk of getting cut, bruised, or injured, use||
1134|080|P|caution with sharp objects like razors and nail cutters, and||
1134|081|P|avoid activities such as contact sports.||
1134|082|P|   This drug may rarely make your blood sugar rise, which can||
1134|083|P|cause or worsen diabetes. If you have diabetes, check your blood||
1134|084|P|sugar regularly as directed and share the results with your||
1134|085|P|doctor. Tell your doctor right away if you have symptoms of high||
1134|086|P|blood sugar such as increased thirst/urination. Your doctor may||
1134|087|P|need to adjust your diabetes medication, exercise program, or||
1134|088|P|diet.||
1134|089|P|   Tell your doctor if you are pregnant or plan to become||
1134|090|P|pregnant. You should not become pregnant while using||
1134|091|P|pegaspargase. Pegaspargase may harm an unborn baby. Your doctor||
1134|092|P|should order a pregnancy test before you start this medication.||
1134|093|P|Ask about reliable forms of non-hormonal birth control (such as||
1134|094|P|condoms, diaphragm with spermicide) while using this medication||
1134|095|P|and for 3 months after the last dose. If you become pregnant,||
1134|096|P|talk to your doctor right away about the risks and benefits of||
1134|097|P|this medication.||
1134|098|P|   It is unknown if this drug passes into breast milk. Because of||
1134|099|P|the possible risk to the infant, breastfeeding is not recommended||
1134|100|P|while using this drug and for at least 1 month after the last||
1134|101|P|dose. Consult your doctor before breastfeeding.||
1134|102|B|||
1134|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1134|104|I|medications work or increase your risk for serious side effects.||
1134|105|I|This document does not contain all possible drug interactions.||
1134|106|I|Keep a list of all the products you use (including||
1134|107|I|prescription/nonprescription drugs and herbal products) and share||
1134|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
1134|109|I|the dosage of any medicines without your doctor's approval.||
1134|110|B|||
1134|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1134|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1134|113|O|poison control center right away. US residents can call||
1134|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1134|115|B|||
1134|116|N|NOTES:  Lab and/or medical tests (such as prothrombin time,||
1134|117|N|complete blood counts, liver function, amylase levels, blood||
1134|118|N|sugar) should be done while you are using this medication. Keep||
1134|119|N|all medical and lab appointments. Consult your doctor for more||
1134|120|N|details.||
1134|121|B|||
1134|122|D|MISSED DOSE:  It is important to get each dose of this medication||
1134|123|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1134|124|D|right away for a new dosing schedule.||
1134|125|B|||
1134|126|R|STORAGE:  Not applicable. This medication is given in a clinic||
1134|127|R|and will not be stored at home.||
1134|128|B|||
1134|129|M|MEDICAL ALERT:  Your condition can cause complications in a||
1134|130|M|medical emergency. For information about enrolling in MedicAlert,||
1134|131|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1134|132|B|||
1134|133|A|Information last revised April 2025.||
1134|134|A|Copyright(c) 2025 First Databank, Inc.||
1134|135|B|||
1135|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1135|002|Z|does NOT have all possible information about this product. This||
1135|003|Z|information does not assure that this product is safe, effective,||
1135|004|Z|or appropriate for you. This information is not individual||
1135|005|Z|medical advice and does not substitute for the advice of your||
1135|006|Z|health care professional. Always ask your health care||
1135|007|Z|professional for complete information about this product and your||
1135|008|Z|specific health needs.||
1135|009|B|||
1135|010|T|DACARBAZINE - INJECTION||
1135|011|F|(duh-KAR-buh-zeen)||
1135|012|B|||
1135|013|C|COMMON BRAND NAME(S): DTIC-Dome||
1135|014|B|||
1135|015|W|WARNING:  This medication may often cause serious blood disorders||
1135|016|W|(decreased bone marrow function leading to a low number of red||
1135|017|W|blood cells, white blood cells, and platelets). These effects can||
1135|018|W|cause anemia, lower your body's ability to fight an infection,||
1135|019|W|and increase your risk of bleeding. Dacarbazine may also cause||
1135|020|W|rare but serious liver problems. These side effects may rarely be||
1135|021|W|life-threatening. Your doctor will monitor you closely while you||
1135|022|W|are receiving this medication.||
1135|023|W|   Tell your doctor right away if you develop any of the||
1135|024|W|following symptoms: nausea/vomiting that doesn't stop, unusual||
1135|025|W|tiredness, pale skin, easy bruising/bleeding, signs of infection||
1135|026|W|(such as sore throat that doesn't go away, fever, chills), dark||
1135|027|W|urine, yellowing eyes/skin, stomach/abdominal pain.||
1135|028|B|||
1135|029|U|USES:  Dacarbazine is used to treat certain types of cancer, such||
1135|030|U|as skin cancer and Hodgkin's disease. It is a cancer chemotherapy||
1135|031|U|drug that is used to slow or stop cancer cell growth.||
1135|032|B|||
1135|033|H|HOW TO USE:  This medication is given by injection into a vein by||
1135|034|H|a health care professional. It is given on a schedule as directed||
1135|035|H|by your doctor. The dosage is based on your medical condition,||
1135|036|H|body size, and response to treatment.||
1135|037|B|||
1135|038|S|SIDE EFFECTS:  See also Warning section.||
1135|039|S|   Nausea, vomiting, and loss of appetite commonly occur.||
1135|040|S|Vomiting may last up to 12 hours. Your doctor may prescribe||
1135|041|S|medication to prevent or relieve nausea and vomiting. Eating||
1135|042|S|several small meals, not eating for 4 to 6 hours before||
1135|043|S|treatment, or limiting activity may help lessen these effects.||
1135|044|S|These symptoms usually decrease after 1 to 2 days. Diarrhea,||
1135|045|S|flu-like symptoms (such as discomfort, uneasiness, body aches,||
1135|046|S|headache), blurred vision, or flushing/numbness/tingling of the||
1135|047|S|face may also occur. If any of these effects last or get worse,||
1135|048|S|tell your doctor or pharmacist promptly.||
1135|049|S|   Temporary hair loss may occur. Normal hair growth should||
1135|050|S|return after treatment has ended.||
1135|051|S|   People using this medication may have serious side effects.||
1135|052|S|However, you have been prescribed this drug because your doctor||
1135|053|S|has judged that the benefit to you is greater than the risk of||
1135|054|S|side effects. Careful monitoring by your doctor may decrease your||
1135|055|S|risk.||
1135|056|S|   If this medication leaks out of the vein into the tissue under||
1135|057|S|the skin, it may cause serious tissue damage. Tell your doctor||
1135|058|S|right away if you experience pain, burning, redness, or swelling||
1135|059|S|at the injection site.||
1135|060|S|   Tell your doctor right away if you have any serious side||
1135|061|S|effects, including: mouth sores, confusion, seizures.||
1135|062|S|   A very serious allergic reaction to this drug is rare.||
1135|063|S|However, get medical help right away if you notice any symptoms||
1135|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1135|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1135|066|S|breathing.||
1135|067|S|   This is not a complete list of possible side effects. If you||
1135|068|S|notice other effects not listed above, contact your doctor or||
1135|069|S|pharmacist.||
1135|070|S|   In the US -||
1135|071|S|   Call your doctor for medical advice about side effects. You||
1135|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1135|073|S|www.fda.gov/medwatch.||
1135|074|S|   In Canada - Call your doctor for medical advice about side||
1135|075|S|effects. You may report side effects to Health Canada at||
1135|076|S|1-866-234-2345.||
1135|077|B|||
1135|078|P|PRECAUTIONS:  Before using dacarbazine, tell your doctor or||
1135|079|P|pharmacist if you are allergic to it; or if you have any other||
1135|080|P|allergies. This product may contain inactive ingredients, which||
1135|081|P|can cause allergic reactions or other problems. Talk to your||
1135|082|P|pharmacist for more details.||
1135|083|P|   Before using this medication, tell your doctor or pharmacist||
1135|084|P|your medical history, especially of: kidney disease, liver||
1135|085|P|disease, blood disorders, decreased bone marrow function, current||
1135|086|P|infections.||
1135|087|P|   Tell your health care professional that you are using||
1135|088|P|dacarbazine before having any immunizations/vaccinations. Avoid||
1135|089|P|contact with people who have recently received live vaccines||
1135|090|P|(such as flu vaccine inhaled through the nose).||
1135|091|P|   Dacarbazine can make you more likely to get infections or may||
1135|092|P|make current infections worse. Stay away from anyone who has an||
1135|093|P|infection that may easily spread (such as chickenpox, COVID-19,||
1135|094|P|measles, flu). Talk to your doctor if you have been exposed to an||
1135|095|P|infection or for more details.||
1135|096|P|   To lower the chance of getting cut, bruised, or injured, use||
1135|097|P|caution with sharp objects like safety razors and nail cutters,||
1135|098|P|and avoid activities such as contact sports.||
1135|099|P|   This drug may rarely cause blurred vision. Do not drive, use||
1135|100|P|machinery, or do anything that needs clear vision until you can||
1135|101|P|do it safely.||
1135|102|P|   This medication may make you more sensitive to the sun. Limit||
1135|103|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1135|104|P|sunscreen and wear protective clothing when outdoors. Tell your||
1135|105|P|doctor right away if you get sunburned or have skin||
1135|106|P|blisters/redness.||
1135|107|P|   During pregnancy, this medication should be used only when||
1135|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
1135|109|P|   It is unknown if this drug passes into breast milk. Because of||
1135|110|P|the possible risk to the infant, breastfeeding is not recommended||
1135|111|P|while using this drug. Consult your doctor before breastfeeding.||
1135|112|B|||
1135|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1135|114|I|medications work or increase your risk for serious side effects.||
1135|115|I|This document does not contain all possible drug interactions.||
1135|116|I|Keep a list of all the products you use (including||
1135|117|I|prescription/nonprescription drugs and herbal products) and share||
1135|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
1135|119|I|the dosage of any medicines without your doctor's approval.||
1135|120|B|||
1135|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1135|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1135|123|O|poison control center right away. US residents can call||
1135|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1135|125|B|||
1135|126|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
1135|127|N|should be done while you are using this medication. Keep all||
1135|128|N|medical and lab appointments. Consult your doctor for more||
1135|129|N|details.||
1135|130|B|||
1135|131|D|MISSED DOSE:  It is important to get each dose of this medication||
1135|132|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1135|133|D|right away for a new dosing schedule.||
1135|134|B|||
1135|135|R|STORAGE:  Not applicable. This medication is given in a clinic||
1135|136|R|and will not be stored at home.||
1135|137|B|||
1135|138|M|MEDICAL ALERT:  Your condition can cause complications in a||
1135|139|M|medical emergency. For information about enrolling in MedicAlert,||
1135|140|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1135|141|B|||
1135|142|A|Information last revised April 2025.||
1135|143|A|Copyright(c) 2025 First Databank, Inc.||
1135|144|B|||
1136|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1136|002|Z|does NOT have all possible information about this product. This||
1136|003|Z|information does not assure that this product is safe, effective,||
1136|004|Z|or appropriate for you. This information is not individual||
1136|005|Z|medical advice and does not substitute for the advice of your||
1136|006|Z|health care professional. Always ask your health care||
1136|007|Z|professional for complete information about this product and your||
1136|008|Z|specific health needs.||
1136|009|B|||
1136|010|T|IRINOTECAN - INJECTION||
1136|011|F|(eye-ree-no-TEE-kan)||
1136|012|B|||
1136|013|C|COMMON BRAND NAME(S): Camptosar||
1136|014|B|||
1136|015|W|WARNING:  You will be closely monitored (for example, by having||
1136|016|W|blood tests) by your doctor while using this medication. Keep all||
1136|017|W|medical and lab appointments.||
1136|018|W|   Irinotecan may cause severe diarrhea, which can occur during||
1136|019|W|or right after you receive this medication and/or more than 24||
1136|020|W|hours afterward. If the diarrhea starts right away, you may also||
1136|021|W|have other side effects such as runny nose, increased saliva,||
1136|022|W|watery eyes, sweating, stomach cramps, or flushing. If the||
1136|023|W|diarrhea starts later, it could be a different type that may not||
1136|024|W|stop and can cause serious (possibly fatal) loss of too much body||
1136|025|W|water (dehydration), mineral imbalance, or serious infection||
1136|026|W|(sepsis). Tell your doctor right away if you have diarrhea and/or||
1136|027|W|any of the symptoms that occur with the early form of diarrhea.||
1136|028|W|Also tell your doctor if you have stomach/abdominal pain, extreme||
1136|029|W|thirst, very dry mouth, muscle cramps/weakness,||
1136|030|W|fast/slow/irregular heartbeat, fainting, dizziness,||
1136|031|W|lightheadedness, or signs of infection (such as sore throat that||
1136|032|W|doesn't go away, fever, chills). Your doctor should prescribe||
1136|033|W|other medications to treat the diarrhea and other symptoms.||
1136|034|W|   This medication may cause very serious (possibly fatal) blood||
1136|035|W|disorders (decreased bone marrow function leading to low number||
1136|036|W|of blood cells such as white cells, red cells, and platelets).||
1136|037|W|This effect can decrease your body's ability to fight an||
1136|038|W|infection, cause your body to bruise or bleed easier, or cause||
1136|039|W|anemia. Tell your doctor right away if you develop any of the||
1136|040|W|following: signs of infection (such as sore throat that doesn't||
1136|041|W|go away, fever, chills), easy bruising/bleeding, unusual||
1136|042|W|tiredness, fast/pounding heartbeat.||
1136|043|B|||
1136|044|U|USES:  This medication is used to treat cancer of the colon and||
1136|045|U|rectum.||
1136|046|B|||
1136|047|V|OTHER USES:  This section contains uses of this drug that are not||
1136|048|V|listed in the approved professional labeling for the drug but||
1136|049|V|that may be prescribed by your health care professional. Use this||
1136|050|V|drug for a condition that is listed in this section only if it||
1136|051|V|has been so prescribed by your health care professional.||
1136|052|V|   This drug may also be used for other types of cancer (such as||
1136|053|V|lung, bone cancer).||
1136|054|B|||
1136|055|H|HOW TO USE:  This medication is given by injection into a vein by||
1136|056|H|a health care professional. The dosage is based on your medical||
1136|057|H|condition, body size, and response to treatment.||
1136|058|H|   If this medication comes into contact with your skin, wash the||
1136|059|H|skin right away and completely with soap and water. If this||
1136|060|H|medication gets into your eyes, mouth, or nose, flush completely||
1136|061|H|with plenty of water. Consult your doctor for more details.||
1136|062|B|||
1136|063|S|SIDE EFFECTS:  See also Warning section.||
1136|064|S|   Nausea, vomiting, loss of appetite, constipation, cough,||
1136|065|S|drowsiness, mouth sores, weakness, or trouble sleeping may occur.||
1136|066|S|Nausea and vomiting can be severe. In some cases, your doctor may||
1136|067|S|prescribe medication to prevent or relieve nausea and vomiting.||
1136|068|S|Eating several small meals, not eating before treatment, or||
1136|069|S|limiting activity may help lessen some of these effects. If these||
1136|070|S|effects last or get worse, or if you are unable to drink/eat||
1136|071|S|because of nausea/vomiting, tell your doctor or pharmacist||
1136|072|S|promptly.||
1136|073|S|   Temporary hair loss may occur. Normal hair growth should||
1136|074|S|return after treatment has ended.||
1136|075|S|   To reduce the risk of dizziness and lightheadedness, get up||
1136|076|S|slowly when rising from a sitting or lying position.||
1136|077|S|   Remember that this medication has been prescribed because your||
1136|078|S|doctor has judged that the benefit to you is greater than the||
1136|079|S|risk of side effects. Many people using this medication do not||
1136|080|S|have serious side effects.||
1136|081|S|   Tell your doctor right away if you have any serious side||
1136|082|S|effects, including: pain/redness/swelling at the injection site||
1136|083|S|or arms/legs, numbness/tingling/burning of arms/legs,||
1136|084|S|black/bloody stools, signs of kidney problems (such as change in||
1136|085|S|the amount of urine), lung problems (such as shortness of breath,||
1136|086|S|cough).||
1136|087|S|   Get medical help right away if you have any very serious side||
1136|088|S|effects, including: chest pain, weakness on one side of the body,||
1136|089|S|trouble speaking, confusion, trouble breathing.||
1136|090|S|   A very serious allergic reaction to this drug is rare.||
1136|091|S|However, get medical help right away if you notice any symptoms||
1136|092|S|of a serious allergic reaction, including: rash, itching/swelling||
1136|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1136|094|S|breathing.||
1136|095|S|   Irinotecan can commonly cause a mild rash that is usually not||
1136|096|S|serious. However, you may not be able to tell it apart from a||
1136|097|S|rare rash that could be a sign of a severe allergic reaction. Get||
1136|098|S|medical help right away if you develop any rash.||
1136|099|S|   This is not a complete list of possible side effects. If you||
1136|100|S|notice other effects not listed above, contact your doctor or||
1136|101|S|pharmacist.||
1136|102|S|   In the US -||
1136|103|S|   Call your doctor for medical advice about side effects. You||
1136|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1136|105|S|www.fda.gov/medwatch.||
1136|106|S|   In Canada - Call your doctor for medical advice about side||
1136|107|S|effects. You may report side effects to Health Canada at||
1136|108|S|1-866-234-2345.||
1136|109|B|||
1136|110|P|PRECAUTIONS:  Before using irinotecan, tell your doctor or||
1136|111|P|pharmacist if you are allergic to it; or if you have any other||
1136|112|P|allergies. This product may contain inactive ingredients, which||
1136|113|P|can cause allergic reactions or other problems. Talk to your||
1136|114|P|pharmacist for more details.||
1136|115|P|   Before using this drug, tell your doctor your medical history,||
1136|116|P|including: bowel blockage (such as paralytic ileus), certain||
1136|117|P|genetic metabolism disorder (fructose intolerance), radiation||
1136|118|P|treatments, blood/bone marrow disorders (such as low||
1136|119|P|platelet/neutrophil/red blood cell levels), diabetes, liver||
1136|120|P|disease, kidney disease, lung disease.||
1136|121|P|   Before having surgery, tell your doctor or dentist about all||
1136|122|P|the products you use (including prescription drugs,||
1136|123|P|nonprescription drugs, and herbal products).||
1136|124|P|   This drug may make you dizzy or drowsy or blur your vision.||
1136|125|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1136|126|P|drowsy. Do not drive, use machinery, or do anything that needs||
1136|127|P|alertness or clear vision until you can do it safely. Limit||
1136|128|P|alcoholic beverages. Talk to your doctor if you are using||
1136|129|P|marijuana (cannabis).||
1136|130|P|   Do not have immunizations/vaccinations without the consent of||
1136|131|P|your doctor, and avoid contact with people who have recently||
1136|132|P|received oral polio vaccine or flu vaccine inhaled through the||
1136|133|P|nose.||
1136|134|P|   To lower your risk of getting cut, bruised, or injured, use||
1136|135|P|caution with sharp objects like razors and nail cutters, and||
1136|136|P|avoid activities such as contact sports.||
1136|137|P|   Wash your hands well to prevent the spread of infections.||
1136|138|P|   Older adults may be at greater risk for diarrhea while using||
1136|139|P|this drug.||
1136|140|P|   Tell your doctor if you are pregnant or plan to become||
1136|141|P|pregnant. You should not become pregnant while using irinotecan.||
1136|142|P|Irinotecan may harm an unborn baby. Your doctor should order a||
1136|143|P|pregnancy test before you start this medication. Women using this||
1136|144|P|medication should ask about reliable forms of birth control||
1136|145|P|during treatment and for 6 months after the last dose. Men using||
1136|146|P|this medication should ask about reliable forms of birth control||
1136|147|P|during treatment and for 3 months after the last dose. If you or||
1136|148|P|your partner becomes pregnant, talk to your doctor right away||
1136|149|P|about the risks and benefits of this medication.||
1136|150|P|   This drug passes into breast milk. Because of the possible||
1136|151|P|risk to the infant, breastfeeding is not recommended while using||
1136|152|P|this drug and for at least 7 days after the last dose. Consult||
1136|153|P|your doctor before breastfeeding.||
1136|154|B|||
1136|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1136|156|I|medications work or increase your risk for serious side effects.||
1136|157|I|This document does not contain all possible drug interactions.||
1136|158|I|Keep a list of all the products you use (including||
1136|159|I|prescription/nonprescription drugs and herbal products) and share||
1136|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
1136|161|I|the dosage of any medicines without your doctor's approval.||
1136|162|I|   Some products that may interact with this drug include:||
1136|163|I|laxatives, "water pills"/diuretics (such as furosemide).||
1136|164|I|   Other medications can affect the removal of irinotecan from||
1136|165|I|your body, which may affect how irinotecan works. Examples||
1136|166|I|include adagrasib, azole antifungals (such as ketoconazole,||
1136|167|I|itraconazole), clarithromycin, gemfibrozil, nefazodone, HIV||
1136|168|I|protease inhibitors (such as atazanavir), rifamycins (such as||
1136|169|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
1136|170|I|seizures (such as carbamazepine, phenytoin), among others.||
1136|171|I|   Avoid eating foods or taking products containing turmeric||
1136|172|I|(curcumin) while being treated with irinotecan. It may decrease||
1136|173|I|this medication's effects. Consult your doctor or pharmacist for||
1136|174|I|more details.||
1136|175|B|||
1136|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1136|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1136|178|O|poison control center right away. US residents can call||
1136|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1136|180|O|Symptoms of overdose may include: signs of infection (such as||
1136|181|O|sore throat that doesn't go away, fever), severe diarrhea.||
1136|182|B|||
1136|183|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1136|184|N|hemoglobin, platelets) should be done while you are using this||
1136|185|N|medication. Keep all medical and lab appointments. Consult your||
1136|186|N|doctor for more details.||
1136|187|B|||
1136|188|D|MISSED DOSE:  It is important to get each dose of this medication||
1136|189|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1136|190|D|right away for a new dosing schedule.||
1136|191|B|||
1136|192|R|STORAGE:  Consult the product instructions and your pharmacist||
1136|193|R|for storage details. Keep all medications away from children and||
1136|194|R|pets.||
1136|195|R|   Do not flush medications down the toilet or pour them into a||
1136|196|R|drain unless instructed to do so. Properly discard this product||
1136|197|R|when it is expired or no longer needed. Consult your pharmacist||
1136|198|R|or local waste disposal company.||
1136|199|B|||
1136|200|M|MEDICAL ALERT:  Your condition can cause complications in a||
1136|201|M|medical emergency. For information about enrolling in MedicAlert,||
1136|202|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1136|203|B|||
1136|204|A|Information last revised May 2025.||
1136|205|A|Copyright(c) 2025 First Databank, Inc.||
1136|206|B|||
1137|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1137|002|Z|does NOT have all possible information about this product. This||
1137|003|Z|information does not assure that this product is safe, effective,||
1137|004|Z|or appropriate for you. This information is not individual||
1137|005|Z|medical advice and does not substitute for the advice of your||
1137|006|Z|health care professional. Always ask your health care||
1137|007|Z|professional for complete information about this product and your||
1137|008|Z|specific health needs.||
1137|009|B|||
1137|010|T|ANASTROZOLE - ORAL||
1137|011|F|(an-AS-troe-zole)||
1137|012|B|||
1137|013|C|COMMON BRAND NAME(S): Arimidex||
1137|014|B|||
1137|015|U|USES:  Anastrozole is used to treat breast cancer in women after||
1137|016|U|menopause. Some breast cancers are made to grow faster by a||
1137|017|U|natural hormone called estrogen. Anastrozole decreases the amount||
1137|018|U|of estrogen the body makes and helps to slow or reverse the||
1137|019|U|growth of these breast cancers.||
1137|020|B|||
1137|021|V|OTHER USES:  This section contains uses of this drug that are not||
1137|022|V|listed in the approved professional labeling for the drug but||
1137|023|V|that may be prescribed by your health care professional. Use this||
1137|024|V|drug for a condition that is listed in this section only if it||
1137|025|V|has been so prescribed by your health care professional.||
1137|026|V|   This medication may also be used to reduce the chances of||
1137|027|V|breast cancer in high-risk patients.||
1137|028|B|||
1137|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1137|030|H|from your pharmacist before you start taking anastrozole and each||
1137|031|H|time you get a refill. If you have any questions, ask your doctor||
1137|032|H|or pharmacist.||
1137|033|H|   Take this medication by mouth with or without food as directed||
1137|034|H|by your doctor, usually once a day.||
1137|035|H|   Use this medication regularly to get the most benefit from it.||
1137|036|H|To help you remember, take it at the same time each day.||
1137|037|H|   Do not increase your dose or use this drug more often or for||
1137|038|H|longer than prescribed. Your condition will not improve any||
1137|039|H|faster, and your risk of serious side effects will increase.||
1137|040|H|   Since this drug can be absorbed through the skin and lungs and||
1137|041|H|may harm an unborn baby, women who are pregnant or who may become||
1137|042|H|pregnant should not handle this medication or breathe the dust||
1137|043|H|from the tablets.||
1137|044|B|||
1137|045|S|SIDE EFFECTS:  Hot flashes, headache, bone pain, trouble||
1137|046|S|sleeping, dizziness, stomach upset, nausea/vomiting,||
1137|047|S|constipation, diarrhea, loss of appetite, weight gain,||
1137|048|S|tiredness/weakness, increased coughing, or sore throat may occur.||
1137|049|S|If any of these effects last or get worse, tell your doctor or||
1137|050|S|pharmacist promptly.||
1137|051|S|   Remember that this medication has been prescribed because your||
1137|052|S|doctor has judged that the benefit to you is greater than the||
1137|053|S|risk of side effects. Many people using this medication do not||
1137|054|S|have serious side effects.||
1137|055|S|   Tell your doctor right away if you have any serious side||
1137|056|S|effects, including: easily broken bones, pain/swelling of the||
1137|057|S|joint/muscle/tendon, mental/mood changes (such as depression),||
1137|058|S|numb/tingling skin, swelling hands/ankle/feet, shortness of||
1137|059|S|breath, unusual vaginal discharge/bleeding/burning/itching/odor,||
1137|060|S|pain/redness/swelling of arms or legs, vision changes, signs of||
1137|061|S|liver disease (such as nausea/vomiting that doesn't stop,||
1137|062|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1137|063|S|   Get medical help right away if you have any very serious side||
1137|064|S|effects, including: chest/jaw/left arm pain, confusion, trouble||
1137|065|S|speaking, weakness on one side of the body.||
1137|066|S|   A very serious allergic reaction to this drug is rare.||
1137|067|S|However, get medical help right away if you notice any symptoms||
1137|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1137|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1137|070|S|breathing.||
1137|071|S|   This is not a complete list of possible side effects. If you||
1137|072|S|notice other effects not listed above, contact your doctor or||
1137|073|S|pharmacist.||
1137|074|S|   In the US -||
1137|075|S|   Call your doctor for medical advice about side effects. You||
1137|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1137|077|S|www.fda.gov/medwatch.||
1137|078|S|   In Canada - Call your doctor for medical advice about side||
1137|079|S|effects. You may report side effects to Health Canada at||
1137|080|S|1-866-234-2345.||
1137|081|B|||
1137|082|P|PRECAUTIONS:  Before taking anastrozole, tell your doctor or||
1137|083|P|pharmacist if you are allergic to it; or if you have any other||
1137|084|P|allergies. This product may contain inactive ingredients, which||
1137|085|P|can cause allergic reactions or other problems. Talk to your||
1137|086|P|pharmacist for more details.||
1137|087|P|   Before using this medication, tell your doctor or pharmacist||
1137|088|P|your medical history, especially of: heart disease (such as||
1137|089|P|history of heart attack), bone loss (osteoporosis), liver||
1137|090|P|disease, high blood pressure, blood clots.||
1137|091|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1137|092|P|can make you more dizzy. Do not drive, use machinery, or do||
1137|093|P|anything that needs alertness until you can do it safely. Limit||
1137|094|P|alcoholic beverages. Talk to your doctor if you are using||
1137|095|P|marijuana (cannabis).||
1137|096|P|   Before having surgery, tell your doctor or dentist about all||
1137|097|P|the products you use (including prescription drugs,||
1137|098|P|nonprescription drugs, and herbal products).||
1137|099|P|   Since this drug can be absorbed through the skin and lungs and||
1137|100|P|may harm an unborn baby, women who are pregnant or who may become||
1137|101|P|pregnant should not handle this medication or breathe the dust||
1137|102|P|from the tablets.||
1137|103|P|   Anastrozole is used mainly in women after menopause. If you||
1137|104|P|have not gone through menopause, this medication must not be used||
1137|105|P|during pregnancy. It may harm an unborn baby. Discuss the use of||
1137|106|P|reliable forms of birth control (such as latex condoms) while||
1137|107|P|taking this medication and for at least 3 weeks after stopping||
1137|108|P|treatment with your doctor. Products containing estrogen (such as||
1137|109|P|birth control pills) should not be used. If you become pregnant||
1137|110|P|or think you may be pregnant, tell your doctor right away.||
1137|111|P|   It is unknown if this drug passes into breast milk. Because of||
1137|112|P|the possible risk to the infant, breastfeeding is not recommended||
1137|113|P|while using this drug and for at least 2 weeks after the last||
1137|114|P|dose. Consult your doctor before breastfeeding.||
1137|115|B|||
1137|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1137|117|I|medications work or increase your risk for serious side effects.||
1137|118|I|This document does not contain all possible drug interactions.||
1137|119|I|Keep a list of all the products you use (including||
1137|120|I|prescription/nonprescription drugs and herbal products) and share||
1137|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
1137|122|I|the dosage of any medicines without your doctor's approval.||
1137|123|I|   Some products that may interact with this drug are: estrogens,||
1137|124|I|tamoxifen, tibolone.||
1137|125|B|||
1137|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1137|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1137|128|O|poison control center right away. US residents can call||
1137|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1137|130|B|||
1137|131|N|NOTES:  Do not share this medication with others.||
1137|132|N|   Lab and/or medical tests (such as cholesterol levels, liver||
1137|133|N|function, bone density) should be done while you are taking this||
1137|134|N|medication. Keep all medical and lab appointments. Consult your||
1137|135|N|doctor for more details.||
1137|136|N|   This medication can increase the risk of bone loss||
1137|137|N|(osteoporosis). Talk with your doctor about your risk, and about||
1137|138|N|available treatments for osteoporosis. Lifestyle changes that may||
1137|139|N|help reduce the risk of bone problems include doing||
1137|140|N|weight-bearing exercise, stopping smoking, limiting alcohol, and||
1137|141|N|getting enough calcium and vitamin D.||
1137|142|B|||
1137|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1137|144|D|remember. If it is near the time of the next dose, skip the||
1137|145|D|missed dose. Take your next dose at the regular time. Do not||
1137|146|D|double the dose to catch up.||
1137|147|B|||
1137|148|R|STORAGE:  Store at room temperature away from light and moisture.||
1137|149|R|Do not store in the bathroom. Keep all medications away from||
1137|150|R|children and pets.||
1137|151|R|   Do not flush medications down the toilet or pour them into a||
1137|152|R|drain unless instructed to do so. Properly discard this product||
1137|153|R|when it is expired or no longer needed. Consult your pharmacist||
1137|154|R|or local waste disposal company.||
1137|155|B|||
1137|156|A|Information last revised September 2025.||
1137|157|A|Copyright(c) 2025 First Databank, Inc.||
1137|158|B|||
1138|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1138|002|Z|does NOT have all possible information about this product. This||
1138|003|Z|information does not assure that this product is safe, effective,||
1138|004|Z|or appropriate for you. This information is not individual||
1138|005|Z|medical advice and does not substitute for the advice of your||
1138|006|Z|health care professional. Always ask your health care||
1138|007|Z|professional for complete information about this product and your||
1138|008|Z|specific health needs.||
1138|009|B|||
1138|010|T|RITONAVIR - ORAL||
1138|011|F|(rye-TAWN-uh-veer)||
1138|012|B|||
1138|013|C|COMMON BRAND NAME(S): Norvir||
1138|014|B|||
1138|015|W|WARNING:  Ritonavir may interact with many different types of||
1138|016|W|medicines, in some cases causing severe (sometimes fatal)||
1138|017|W|reactions. Consult your doctor or pharmacist about which||
1138|018|W|medications should not be taken with ritonavir. (See also Drug||
1138|019|W|Interactions section.)||
1138|020|B|||
1138|021|U|USES:  This drug is used with other HIV medications to help||
1138|022|U|control HIV infection. It helps to decrease the amount of HIV in||
1138|023|U|your body so your immune system can work better. This lowers your||
1138|024|U|chance of getting HIV complications (such as new infections,||
1138|025|U|cancer) and improves your quality of life.||
1138|026|U|   Ritonavir belongs to a class of drugs known as protease||
1138|027|U|inhibitors. It increases ("boosts") the levels of other protease||
1138|028|U|inhibitors, which helps these medications work better.||
1138|029|U|   Ritonavir is not a cure for HIV infection. To decrease your||
1138|030|U|risk of spreading HIV disease to others, continue to take all HIV||
1138|031|U|medications exactly as prescribed by your doctor. Use an||
1138|032|U|effective barrier method (latex or polyurethane condoms/dental||
1138|033|U|dams) during sexual activity as directed by your doctor. Do not||
1138|034|U|share personal items (such as needles/syringes, toothbrushes, and||
1138|035|U|razors) that may have contacted blood or other body fluids.||
1138|036|U|Consult your doctor or pharmacist for more details.||
1138|037|B|||
1138|038|V|OTHER USES:  This section contains uses of this drug that are not||
1138|039|V|listed in the approved professional labeling for the drug but||
1138|040|V|that may be prescribed by your health care professional. Use this||
1138|041|V|drug for a condition that is listed in this section only if it||
1138|042|V|has been so prescribed by your health care professional.||
1138|043|V|   This product may also be used to lessen the risk of HIV||
1138|044|V|infection after contact with the virus (for example, due to a||
1138|045|V|needle stick). Ask your doctor for more details.||
1138|046|B|||
1138|047|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1138|048|H|from your pharmacist before you start taking ritonavir and each||
1138|049|H|time you get a refill. If you have any questions, ask your doctor||
1138|050|H|or pharmacist.||
1138|051|H|   Take this medication by mouth with a meal as directed by your||
1138|052|H|doctor, usually 1 to 2 times daily. Take ritonavir at the same||
1138|053|H|time(s) as your other HIV protease inhibitor. Swallow the tablet||
1138|054|H|form of this medication whole. Do not crush, chew, or break the||
1138|055|H|tablets.||
1138|056|H|   The dosage is based on your medical condition, response to||
1138|057|H|treatment, and other medications you may be taking. Be sure to||
1138|058|H|tell your doctor and pharmacist about all the products you use||
1138|059|H|(including prescription drugs, nonprescription drugs, and herbal||
1138|060|H|products). Children's dosage may also be based on body size.||
1138|061|H|   For the best effect, take this medication at evenly spaced||
1138|062|H|times. To help you remember, take this medication at the same||
1138|063|H|time(s) every day.||
1138|064|H|   The tablet and capsule forms of this medication may deliver||
1138|065|H|different amounts of medication. Do not switch between the tablet||
1138|066|H|and capsule forms without your doctor's permission and||
1138|067|H|directions.||
1138|068|H|   It is very important to keep taking this medication (and other||
1138|069|H|HIV medications) exactly as prescribed by your doctor. Do not||
1138|070|H|take more or less of this drug than prescribed or stop taking it||
1138|071|H|(or other HIV medicines) even for a short time unless directed to||
1138|072|H|do so by your doctor. Skipping or changing your dose without||
1138|073|H|approval from your doctor may cause the amount of virus to||
1138|074|H|increase, make the infection more difficult to treat, or worsen||
1138|075|H|side effects.||
1138|076|B|||
1138|077|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, heartburn, stomach||
1138|078|S|pain, dizziness, tiredness, weakness, changes in taste, or||
1138|079|S|tingling/numbness of mouth area may occur. If any of these||
1138|080|S|effects last or get worse, tell your doctor or pharmacist||
1138|081|S|promptly.||
1138|082|S|   Remember that this medication has been prescribed because your||
1138|083|S|doctor has judged that the benefit to you is greater than the||
1138|084|S|risk of side effects. Many people using this medication do not||
1138|085|S|have serious side effects.||
1138|086|S|   As your immune system gets stronger, it can begin to fight off||
1138|087|S|infections you already had, possibly causing disease symptoms to||
1138|088|S|come back. You could also have symptoms if your immune system||
1138|089|S|becomes overactive. This reaction may happen at any time (soon||
1138|090|S|after starting HIV treatment or many months later). Tell your||
1138|091|S|doctor right away if you have any serious symptoms, including:||
1138|092|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1138|093|S|that doesn't go away, headaches that are severe or don't go away,||
1138|094|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1138|095|S|changes, signs of infection (such as sore throat that doesn't go||
1138|096|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1138|097|S|sores), signs of an overactive thyroid (such as irritability,||
1138|098|S|nervousness, heat intolerance, fast/pounding/irregular||
1138|099|S|heartbeat).||
1138|100|S|   Tell your doctor right away if you have any serious side||
1138|101|S|effects, including: nausea/vomiting that doesn't stop,||
1138|102|S|stomach/abdominal pain, dark urine, loss of appetite, yellowing||
1138|103|S|eyes/skin, mental/mood changes (such as depression, anxiety),||
1138|104|S|increased urination (especially at night), increased thirst.||
1138|105|S|   Get medical help right away if you have any very serious side||
1138|106|S|effects, including: symptoms of a heart attack (such as||
1138|107|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
1138|108|S|easy bruising/bleeding, fainting, fast/irregular heartbeat.||
1138|109|S|   Changes in body fat may occur while you are taking this||
1138|110|S|medication (such as increased fat in the upper back and stomach||
1138|111|S|areas, decreased fat in the arms and legs). The cause and||
1138|112|S|long-term effects of these changes are unknown. Discuss the risks||
1138|113|S|and benefits of treatment with your doctor, as well as the||
1138|114|S|possible use of exercise to reduce this side effect.||
1138|115|S|   A very serious allergic reaction to this drug is rare.||
1138|116|S|However, get medical help right away if you notice any symptoms||
1138|117|S|of a serious allergic reaction, including: rash, itching/swelling||
1138|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1138|119|S|breathing.||
1138|120|S|   This is not a complete list of possible side effects. If you||
1138|121|S|notice other effects not listed above, contact your doctor or||
1138|122|S|pharmacist.||
1138|123|S|   In the US -||
1138|124|S|   Call your doctor for medical advice about side effects. You||
1138|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1138|126|S|www.fda.gov/medwatch.||
1138|127|S|   In Canada - Call your doctor for medical advice about side||
1138|128|S|effects. You may report side effects to Health Canada at||
1138|129|S|1-866-234-2345.||
1138|130|B|||
1138|131|P|PRECAUTIONS:  Before taking ritonavir, tell your doctor or||
1138|132|P|pharmacist if you are allergic to it; or if you have any other||
1138|133|P|allergies. This product may contain inactive ingredients, which||
1138|134|P|can cause allergic reactions or other problems. Talk to your||
1138|135|P|pharmacist for more details.||
1138|136|P|   Before using this medication, tell your doctor or pharmacist||
1138|137|P|your medical history, especially of: diabetes, heart problems||
1138|138|P|(coronary artery disease, heart attack), hemophilia, high||
1138|139|P|cholesterol/triglycerides, liver problems (such as hepatitis B,||
1138|140|P|hepatitis C), pancreatitis.||
1138|141|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1138|142|P|can make you more dizzy. Do not drive, use machinery, or do||
1138|143|P|anything that needs alertness until you can do it safely. Limit||
1138|144|P|alcoholic beverages. Talk to your doctor if you are using||
1138|145|P|marijuana (cannabis).||
1138|146|P|   If you have diabetes, this product may increase your blood||
1138|147|P|sugar. Check your blood sugar regularly as directed and share the||
1138|148|P|results with your doctor. Tell your doctor right away if you have||
1138|149|P|symptoms of high blood sugar such as increased thirst/urination.||
1138|150|P|Your doctor may need to adjust your diabetes medication, exercise||
1138|151|P|program, or diet.||
1138|152|P|   Before having surgery, tell your doctor or dentist about all||
1138|153|P|the products you use (including prescription drugs,||
1138|154|P|nonprescription drugs, and herbal products).||
1138|155|P|   Tell your doctor if you are pregnant before using this||
1138|156|P|medication. Treatment can lower the risk of passing HIV infection||
1138|157|P|to your baby. Discuss the risks and benefits with your doctor.||
1138|158|P|   This medication passes into breast milk. Because breast milk||
1138|159|P|may transmit HIV, consult your doctor before breastfeeding.||
1138|160|B|||
1138|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1138|162|I|medications work or increase your risk for serious side effects.||
1138|163|I|This document does not contain all possible drug interactions.||
1138|164|I|Keep a list of all the products you use (including||
1138|165|I|prescription/nonprescription drugs and herbal products) and share||
1138|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
1138|167|I|the dosage of any medicines without your doctor's approval.||
1138|168|I|   Ritonavir interacts with many medications. Some products that||
1138|169|I|may interact with this drug include: cobicistat, disulfiram,||
1138|170|I|orlistat.||
1138|171|I|   Ritonavir can slow down or speed up the removal of other||
1138|172|I|medications from your body, which may affect how they work.||
1138|173|I|Examples of affected drugs include alfuzosin, antiarrhythmics||
1138|174|I|(such as amiodarone, flecainide, propafenone, quinidine), azole||
1138|175|I|antifungals (such as voriconazole), certain benzodiazepines||
1138|176|I|(midazolam, triazolam), certain "blood thinners" (such as||
1138|177|I|rivaroxaban, warfarin), eletriptan, drugs to treat erectile||
1138|178|I|dysfunction-ED or pulmonary hypertension (such as avanafil,||
1138|179|I|sildenafil), ergot alkaloids (such as dihydroergotamine,||
1138|180|I|ergonovine, ergotamine, methylergonovine), lurasidone, certain||
1138|181|I|opioid pain medications (such as fentanyl, meperidine), pimozide,||
1138|182|I|ranolazine, salmeterol, "statin" cholesterol drugs (such as||
1138|183|I|simvastatin, lovastatin), among others.||
1138|184|I|   Other medications can affect the removal of ritonavir from||
1138|185|I|your body, which may affect how ritonavir works. Examples include||
1138|186|I|apalutamide, rifampin, St. John's wort, among others.||
1138|187|I|   This medication may decrease the effectiveness of hormonal||
1138|188|I|birth control such as pills, patch, or ring. This could cause||
1138|189|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1138|190|I|use reliable backup birth control methods while using this||
1138|191|I|medication. Also tell your doctor if you have any new spotting or||
1138|192|I|breakthrough bleeding, because these may be signs that your birth||
1138|193|I|control is not working well.||
1138|194|B|||
1138|195|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1138|196|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1138|197|O|poison control center right away. US residents can call||
1138|198|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1138|199|B|||
1138|200|N|NOTES:  Do not share this medication with others.||
1138|201|N|   Lab and/or medical tests (such as liver function, viral load,||
1138|202|N|T-cell counts, triglycerides/cholesterol, blood sugar) should be||
1138|203|N|done while you are taking this medication. Keep all medical and||
1138|204|N|lab appointments. Consult your doctor for more details.||
1138|205|B|||
1138|206|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1138|207|D|remember. If it is near the time of the next dose, skip the||
1138|208|D|missed dose. Take your next dose at the regular time. Do not||
1138|209|D|double the dose to catch up.||
1138|210|B|||
1138|211|R|STORAGE:  Store the capsules in the refrigerator away from light.||
1138|212|R|Do not freeze. The capsules may also be stored at room||
1138|213|R|temperature if needed. If the capsules are stored at room||
1138|214|R|temperature, discard after 30 days. Store the tablets at room||
1138|215|R|temperature away from light and moisture. Do not store in the||
1138|216|R|bathroom. Keep all medications away from children and pets.||
1138|217|R|   Do not flush medications down the toilet or pour them into a||
1138|218|R|drain unless instructed to do so. Properly discard this product||
1138|219|R|when it is expired or no longer needed. Consult your pharmacist||
1138|220|R|or local waste disposal company.||
1138|221|B|||
1138|222|A|Information last revised April 2025.||
1138|223|A|Copyright(c) 2025 First Databank, Inc.||
1138|224|B|||
1139|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1139|002|Z|does NOT have all possible information about this product. This||
1139|003|Z|information does not assure that this product is safe, effective,||
1139|004|Z|or appropriate for you. This information is not individual||
1139|005|Z|medical advice and does not substitute for the advice of your||
1139|006|Z|health care professional. Always ask your health care||
1139|007|Z|professional for complete information about this product and your||
1139|008|Z|specific health needs.||
1139|009|B|||
1139|010|T|TOPOTECAN - ORAL||
1139|011|F|(TOE-poe-TEE-kan)||
1139|012|B|||
1139|013|C|COMMON BRAND NAME(S): Hycamtin||
1139|014|B|||
1139|015|W|WARNING:  Topotecan decreases bone marrow function. This effect||
1139|016|W|may lead to a low number of blood cells such as red cells, white||
1139|017|W|cells, and platelets. A low number of blood cells can cause||
1139|018|W|anemia, decrease your body's ability to fight an infection, or||
1139|019|W|cause your body to bruise or bleed more easily. Tell your doctor||
1139|020|W|right away if you develop any of the following symptoms: unusual||
1139|021|W|tiredness, pale skin, signs of infection (such as sore throat||
1139|022|W|that doesn't go away, fever, chills), easy bruising/bleeding.||
1139|023|W|   Your doctor will order frequent blood tests to monitor your||
1139|024|W|bone marrow function while you are taking this medication. Keep||
1139|025|W|all medical and lab appointments.||
1139|026|B|||
1139|027|U|USES:  This medication is used to treat small cell lung cancer.||
1139|028|U|It works by killing cancer cells or slowing their growth.||
1139|029|B|||
1139|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1139|031|H|from your pharmacist before you start taking topotecan and each||
1139|032|H|time you get a refill. If you have any questions, ask your doctor||
1139|033|H|or pharmacist.||
1139|034|H|   Take this medication by mouth with or without food as directed||
1139|035|H|by your doctor, usually once daily for 5 days. Each 5-day||
1139|036|H|treatment period is called a cycle. You will usually repeat this||
1139|037|H|cycle every 21 days. The dosage is based on your body size,||
1139|038|H|medical condition, lab tests, and response to treatment.||
1139|039|H|   Swallow the capsules whole. Do not open, crush, or chew the||
1139|040|H|capsules. If the capsule contents touch your skin, wash the skin||
1139|041|H|right away and completely with soap and water. If the contents||
1139|042|H|get into your eyes, mouth, or nose, flush right away with water||
1139|043|H|for at least 15 minutes. Consult your doctor if you have||
1139|044|H|redness/burning/swelling on the area of skin the contents touched||
1139|045|H|or if the contents get into your eyes.||
1139|046|H|   If you vomit after taking a dose, do not take another dose at||
1139|047|H|that time. Take your next dose on your usual dosing schedule.||
1139|048|H|   All people should wash their hands carefully after handling||
1139|049|H|this drug. Women who are pregnant or who may become pregnant||
1139|050|H|should not handle this medication.||
1139|051|B|||
1139|052|S|SIDE EFFECTS:  See also Warning section.||
1139|053|S|   Nausea, vomiting, diarrhea, tiredness, loss of appetite,||
1139|054|S|weakness, and fever may occur. If these effects last or get||
1139|055|S|worse, tell your doctor or pharmacist promptly. Nausea and||
1139|056|S|vomiting can be severe. In some cases, your doctor may prescribe||
1139|057|S|medication to prevent or relieve nausea and vomiting. Eating||
1139|058|S|several small meals, not eating before treatment, or limiting||
1139|059|S|activity may help lessen some of these effects.||
1139|060|S|   Diarrhea can also be severe and may require treatment in a||
1139|061|S|hospital. Tell your doctor right away if you have any diarrhea||
1139|062|S|with fever, diarrhea with stomach pain, or diarrhea 3 or more||
1139|063|S|times a day.||
1139|064|S|   Temporary hair loss may occur. However, normal hair growth||
1139|065|S|should return after treatment has ended.||
1139|066|S|   Remember that this medication has been prescribed because your||
1139|067|S|doctor has judged that the benefit to you is greater than the||
1139|068|S|risk of side effects. Many people using this medication do not||
1139|069|S|have serious side effects.||
1139|070|S|   Tell your doctor right away if you have any serious side||
1139|071|S|effects, including: lung problems (such as cough, shortness of||
1139|072|S|breath).||
1139|073|S|   A very serious allergic reaction to this drug is rare.||
1139|074|S|However, get medical help right away if you notice any symptoms||
1139|075|S|of a serious allergic reaction, including: rash, itching/swelling||
1139|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1139|077|S|breathing.||
1139|078|S|   This is not a complete list of possible side effects. If you||
1139|079|S|notice other effects not listed above, contact your doctor or||
1139|080|S|pharmacist.||
1139|081|S|   In the US -||
1139|082|S|   Call your doctor for medical advice about side effects. You||
1139|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1139|084|S|www.fda.gov/medwatch.||
1139|085|S|   In Canada - Call your doctor for medical advice about side||
1139|086|S|effects. You may report side effects to Health Canada at||
1139|087|S|1-866-234-2345.||
1139|088|B|||
1139|089|P|PRECAUTIONS:  Before using topotecan, tell your doctor or||
1139|090|P|pharmacist if you are allergic to it; or if you have any other||
1139|091|P|allergies. This product may contain inactive ingredients, which||
1139|092|P|can cause allergic reactions or other problems. Talk to your||
1139|093|P|pharmacist for more details.||
1139|094|P|   Before using this medication, tell your doctor or pharmacist||
1139|095|P|your medical history, especially of: kidney problems.||
1139|096|P|   This drug may make you feel weak or tired. Alcohol or||
1139|097|P|marijuana (cannabis) can make you more tired. Do not drive, use||
1139|098|P|machinery, or do anything that needs alertness until you can do||
1139|099|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1139|100|P|are using marijuana (cannabis).||
1139|101|P|   Topotecan can make you more likely to get infections or may||
1139|102|P|make current infections worse. Stay away from anyone who has an||
1139|103|P|infection that may easily spread (such as chickenpox, COVID-19,||
1139|104|P|measles, flu). Talk to your doctor if you have been exposed to an||
1139|105|P|infection or for more details.||
1139|106|P|   Tell your health care professional that you are using||
1139|107|P|topotecan before having any immunizations/vaccinations. Avoid||
1139|108|P|contact with people who have recently received live vaccines||
1139|109|P|(such as flu vaccine inhaled through the nose).||
1139|110|P|   To lower the chance of getting cut, bruised, or injured, use||
1139|111|P|caution with sharp objects like razors and nail cutters, and||
1139|112|P|avoid activities such as contact sports.||
1139|113|P|   Before having surgery, tell your doctor or dentist about all||
1139|114|P|the products you use (including prescription drugs,||
1139|115|P|nonprescription drugs, and herbal products).||
1139|116|P|   Older adults may be more sensitive to the effects of this||
1139|117|P|drug, especially diarrhea and decreased bone marrow function.||
1139|118|P|   This medication can affect fertility in both males and||
1139|119|P|females. Ask your doctor for more details.||
1139|120|P|   Tell your doctor if you are pregnant or plan to become||
1139|121|P|pregnant. You should not become pregnant while using topotecan.||
1139|122|P|Topotecan may harm an unborn baby. Women using this medication||
1139|123|P|should ask about reliable forms of birth control during treatment||
1139|124|P|and for 6 months after the last dose. Men using this medication||
1139|125|P|should ask about reliable forms of birth control during treatment||
1139|126|P|and for 3 months after the last dose. If you or your partner||
1139|127|P|becomes pregnant, talk to your doctor right away about the risks||
1139|128|P|and benefits of this medication.||
1139|129|P|   It is unknown if this drug passes into breast milk. Because of||
1139|130|P|the possible risk to the infant, breastfeeding is not recommended||
1139|131|P|while using this drug and for 1 week after the last dose. Consult||
1139|132|P|your doctor before breastfeeding.||
1139|133|B|||
1139|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1139|135|I|medications work or increase your risk for serious side effects.||
1139|136|I|This document does not contain all possible drug interactions.||
1139|137|I|Keep a list of all the products you use (including||
1139|138|I|prescription/nonprescription drugs and herbal products) and share||
1139|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
1139|140|I|the dosage of any medicines without your doctor's approval.||
1139|141|I|   Other medications can affect the removal of topotecan from||
1139|142|I|your body, which may affect how topotecan works. Examples include||
1139|143|I|azole antifungals (such as ketoconazole), cyclosporine, macrolide||
1139|144|I|antibiotics (such as erythromycin), ritonavir, among others.||
1139|145|B|||
1139|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1139|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1139|148|O|poison control center right away. US residents can call||
1139|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1139|150|B|||
1139|151|N|NOTES:  Do not share this medication with others.||
1139|152|N|   Lab and/or medical tests (such as complete blood count, kidney||
1139|153|N|function) should be done while you are taking this medication.||
1139|154|N|Keep all medical and lab appointments. Consult your doctor for||
1139|155|N|more details.||
1139|156|B|||
1139|157|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1139|158|D|next dose at the regular time. Do not double the dose to catch||
1139|159|D|up.||
1139|160|B|||
1139|161|R|STORAGE:  Store in the refrigerator. Keep all medications away||
1139|162|R|from children and pets.||
1139|163|R|   Do not flush medications down the toilet or pour them into a||
1139|164|R|drain unless instructed to do so. Properly discard this product||
1139|165|R|when it is expired or no longer needed. Consult your pharmacist||
1139|166|R|or local waste disposal company.||
1139|167|B|||
1139|168|M|MEDICAL ALERT:  Your condition can cause complications in a||
1139|169|M|medical emergency. For information about enrolling in MedicAlert,||
1139|170|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1139|171|B|||
1139|172|A|Information last revised May 2024.||
1139|173|A|Copyright(c) 2025 First Databank, Inc.||
1139|174|B|||
1140|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1140|002|Z|does NOT have all possible information about this product. This||
1140|003|Z|information does not assure that this product is safe, effective,||
1140|004|Z|or appropriate for you. This information is not individual||
1140|005|Z|medical advice and does not substitute for the advice of your||
1140|006|Z|health care professional. Always ask your health care||
1140|007|Z|professional for complete information about this product and your||
1140|008|Z|specific health needs.||
1140|009|B|||
1140|010|T|ASPIRIN, BUFFERED WITH CA/AL/MG ANTACID - ORAL||
1140|011|B|||
1140|012|C|COMMON BRAND NAME(S): Ascriptin, Bufferin||
1140|013|B|||
1140|014|U|USES:  This product is a combination of aspirin and an antacid||
1140|015|U|(such as calcium carbonate, aluminum hydroxide, or magnesium||
1140|016|U|oxide). The antacid helps reduce heartburn and upset stomach that||
1140|017|U|aspirin may cause. Aspirin is used to reduce fever and relieve||
1140|018|U|mild to moderate pain from conditions such as muscle aches,||
1140|019|U|toothaches, common cold, and headaches. It may also be used to||
1140|020|U|reduce pain and swelling in conditions such as arthritis.||
1140|021|U|   Aspirin is known as a salicylate and a nonsteroidal||
1140|022|U|anti-inflammatory drug (NSAID). It works by blocking a certain||
1140|023|U|natural substance in your body to reduce pain and swelling.||
1140|024|U|Consult your doctor before treating a child younger than 12||
1140|025|U|years.||
1140|026|U|   Your doctor may direct you to take a low dose of aspirin to||
1140|027|U|prevent blood clots. This effect reduces the risk of stroke and||
1140|028|U|heart attack. If you have recently had surgery on clogged||
1140|029|U|arteries (such as bypass surgery, carotid endarterectomy,||
1140|030|U|coronary stent), your doctor may direct you to use aspirin in low||
1140|031|U|doses as a "blood thinner" to prevent blood clots.||
1140|032|B|||
1140|033|H|HOW TO USE:  If you are taking this medication for||
1140|034|H|self-treatment, follow all directions on the product package. If||
1140|035|H|you have any questions, ask your doctor or pharmacist. If your||
1140|036|H|doctor has directed you to take this medication, take it exactly||
1140|037|H|as prescribed.||
1140|038|H|   Take this medication by mouth. Drink a full glass of water (8||
1140|039|H|ounces/240 milliliters) with it unless your doctor tells you||
1140|040|H|otherwise. Do not lie down for at least 10 minutes after you have||
1140|041|H|taken this drug. If stomach upset occurs while you are taking||
1140|042|H|this medication, you may take it with food or milk.||
1140|043|H|   The dosage and length of treatment are based on your medical||
1140|044|H|condition and response to treatment. Read the product label to||
1140|045|H|find recommendations on how many tablets you can take in a||
1140|046|H|24-hour period and how long you may self-treat before seeking||
1140|047|H|medical advice. Do not take more medication or take it for longer||
1140|048|H|than recommended unless directed by your doctor. Use the smallest||
1140|049|H|effective dose. Consult your doctor or pharmacist if you have any||
1140|050|H|questions.||
1140|051|H|   If you are taking this medication for self-treatment of||
1140|052|H|headache, get medical help right away if you also have trouble||
1140|053|H|speaking, weakness on one side of the body, or sudden vision||
1140|054|H|changes. Before using this drug, consult a doctor or pharmacist||
1140|055|H|if you have headaches caused by head injury, coughing, or||
1140|056|H|bending, or if you have a headache with vomiting that is severe||
1140|057|H|or doesn't go away, fever, and stiff neck.||
1140|058|H|   If you are taking this medication as needed (not on a regular||
1140|059|H|schedule), remember that pain medications work best if they are||
1140|060|H|used as the first signs of pain occur. If you wait until the pain||
1140|061|H|has worsened, the medicine may not work as well.||
1140|062|H|   You should not take this medication for self-treatment of pain||
1140|063|H|for longer than 10 days. You should not use this drug to||
1140|064|H|self-treat a fever that lasts longer than 3 days. In these cases,||
1140|065|H|consult a doctor because you may have a more serious condition.||
1140|066|H|Tell your doctor promptly if you develop ringing in the ears or||
1140|067|H|difficulty hearing.||
1140|068|H|   If your condition lasts or gets worse (such as new or unusual||
1140|069|H|symptoms, redness/swelling of the painful area, pain/fever that||
1140|070|H|does not go away or gets worse) or if you think you may have a||
1140|071|H|serious medical problem, tell your doctor promptly.||
1140|072|B|||
1140|073|S|SIDE EFFECTS:  Upset stomach and heartburn may occur. If either||
1140|074|S|of these effects last or get worse, tell your doctor or||
1140|075|S|pharmacist promptly.||
1140|076|S|   If your doctor has directed you to use this medication,||
1140|077|S|remember that your doctor has judged that the benefit to you is||
1140|078|S|greater than the risk of side effects. Many people using this||
1140|079|S|medication do not have serious side effects.||
1140|080|S|   Tell your doctor right away if you have any serious side||
1140|081|S|effects, including: nausea/vomiting that is severe or doesn't||
1140|082|S|stop, easy bruising/bleeding, difficulty hearing, ringing in the||
1140|083|S|ears, signs of kidney problems (such as change in the amount of||
1140|084|S|urine), unexplained tiredness, dizziness, dark urine, yellowing||
1140|085|S|eyes/skin.||
1140|086|S|   This drug may rarely cause serious bleeding from the||
1140|087|S|stomach/intestine or other areas of the body. If you notice any||
1140|088|S|of the following serious side effects, get medical help right||
1140|089|S|away: stomach/abdominal pain that is severe or doesn't go away,||
1140|090|S|black/tarry stools, vomit that looks like coffee grounds, trouble||
1140|091|S|speaking, weakness on one side of the body, sudden vision changes||
1140|092|S|or severe headache.||
1140|093|S|   A very serious allergic reaction to this drug is rare.||
1140|094|S|However, get medical help right away if you notice any symptoms||
1140|095|S|of a serious allergic reaction, including: fever, swollen lymph||
1140|096|S|nodes, rash, itching/swelling (especially of the||
1140|097|S|face/tongue/throat), severe dizziness, trouble breathing.||
1140|098|S|   This is not a complete list of possible side effects. If you||
1140|099|S|notice other effects not listed above, contact your doctor or||
1140|100|S|pharmacist.||
1140|101|S|   In the US -||
1140|102|S|   Call your doctor for medical advice about side effects. You||
1140|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1140|104|S|www.fda.gov/medwatch.||
1140|105|S|   In Canada - Call your doctor for medical advice about side||
1140|106|S|effects. You may report side effects to Health Canada at||
1140|107|S|1-866-234-2345.||
1140|108|B|||
1140|109|P|PRECAUTIONS:  Before taking aspirin, tell your doctor or||
1140|110|P|pharmacist if you are allergic to it; or to other salicylates||
1140|111|P|(such as choline salicylate); or to other pain relievers or fever||
1140|112|P|reducers (NSAIDs such as ibuprofen, naproxen); or if you have any||
1140|113|P|other allergies. This product may contain inactive ingredients,||
1140|114|P|which can cause allergic reactions or other problems. Talk to||
1140|115|P|your pharmacist for more details.||
1140|116|P|   If you have any of the following health problems, consult your||
1140|117|P|doctor or pharmacist before using this medication:||
1140|118|P|bleeding/blood-clotting disorders (such as hemophilia, vitamin K||
1140|119|P|deficiency, low platelet count), kidney disease, liver disease,||
1140|120|P|stomach problems (such as ulcers, heartburn, stomach pain),||
1140|121|P|asthma (including a history of worsening breathing after taking||
1140|122|P|aspirin or other NSAIDs), growths in the nose (nasal polyps),||
1140|123|P|gout, certain enzyme deficiencies (pyruvate kinase or G6PD||
1140|124|P|deficiency).||
1140|125|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1140|126|P|and tobacco, especially when combined with this product, may||
1140|127|P|increase your risk for this side effect. Limit alcoholic||
1140|128|P|beverages, and stop smoking. Check with your doctor or pharmacist||
1140|129|P|for more information.||
1140|130|P|   Before having surgery, tell your doctor or dentist about all||
1140|131|P|the products you use (including prescription drugs,||
1140|132|P|nonprescription drugs, and herbal products).||
1140|133|P|   Children and teenagers less than 18 years old should not take||
1140|134|P|aspirin if they have chickenpox, flu, or any undiagnosed illness||
1140|135|P|or if they have recently received a vaccine. In these cases,||
1140|136|P|taking aspirin increases the risk of Reye's syndrome, a rare but||
1140|137|P|serious illness. Tell your doctor promptly if you see changes in||
1140|138|P|behavior with nausea and vomiting. This may be an early sign of||
1140|139|P|Reye's syndrome.||
1140|140|P|   Older adults may be more sensitive to the side effects of this||
1140|141|P|drug, especially stomach/intestinal bleeding and ulcers.||
1140|142|P|   Aspirin is not recommended for use to treat pain or fever||
1140|143|P|during pregnancy. Before using this medication, women of||
1140|144|P|childbearing age should talk with their doctor(s) about the||
1140|145|P|benefits and risks. Tell your doctor if you are pregnant or if||
1140|146|P|you plan to become pregnant. This medication may harm an unborn||
1140|147|P|baby and cause problems with normal labor/delivery. It is not||
1140|148|P|recommended for use in pregnancy from 20 weeks until delivery. If||
1140|149|P|your doctor decides that you need to use this medication between||
1140|150|P|20 and 30 weeks of pregnancy, you should use the lowest effective||
1140|151|P|dose for the shortest possible time. In some cases, low-dose||
1140|152|P|aspirin (usually 81-162 milligrams a day) may be used safely||
1140|153|P|during pregnancy to prevent certain conditions. Talk to your||
1140|154|P|doctor for more details.||
1140|155|P|   Aspirin passes into breast milk. When used in large amounts||
1140|156|P|(such as to treat pain or fever), it may harm a nursing infant||
1140|157|P|and breastfeeding is not recommended while using this medication.||
1140|158|P|However, low-dose aspirin for heart attack or stroke prevention||
1140|159|P|may be used if directed by your doctor. Consult your doctor||
1140|160|P|before breastfeeding.||
1140|161|B|||
1140|162|I|DRUG INTERACTIONS:  See also How to Use section.||
1140|163|I|   Drug interactions may change how your medications work or||
1140|164|I|increase your risk for serious side effects. This document does||
1140|165|I|not contain all possible drug interactions. Keep a list of all||
1140|166|I|the products you use (including prescription/nonprescription||
1140|167|I|drugs and herbal products) and share it with your doctor and||
1140|168|I|pharmacist. Do not start, stop, or change the dosage of any||
1140|169|I|medicines without your doctor's approval.||
1140|170|I|   Some products that may interact with this drug include:||
1140|171|I|acetazolamide, "blood thinners" (such as warfarin, heparin),||
1140|172|I|corticosteroids (such as prednisone), dichlorphenamide,||
1140|173|I|methotrexate, mifepristone, valproic acid, herbal medications||
1140|174|I|(such as ginkgo biloba).||
1140|175|I|   This product contains antacids. Antacids can interfere with||
1140|176|I|the absorption of many other drugs. Be sure to check with your||
1140|177|I|pharmacist before taking this product with any other medication.||
1140|178|I|   Before using this product, consult your doctor if you have||
1140|179|I|recently received certain live vaccines (such as varicella||
1140|180|I|vaccine, live flu vaccine).||
1140|181|I|   Check all prescription and nonprescription medicine labels||
1140|182|I|carefully since many medications contain pain relievers/fever||
1140|183|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
1140|184|I|naproxen). These drugs are similar to this medication and may||
1140|185|I|increase your risk of side effects if taken together.||
1140|186|I|   Daily use of NSAIDs (such as ibuprofen) may decrease aspirin's||
1140|187|I|ability to prevent heart attack/stroke. If you are taking||
1140|188|I|low-dose aspirin for prevention of heart attack/stroke, consult||
1140|189|I|your doctor or pharmacist for more details and to discuss other||
1140|190|I|possible treatments (such as acetaminophen) for your pain/fever.||
1140|191|I|   This medication may interfere with certain lab tests (such as||
1140|192|I|certain urine sugar tests), possibly causing false test results.||
1140|193|I|Make sure lab personnel and all your doctors know you use this||
1140|194|I|drug.||
1140|195|B|||
1140|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1140|197|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1140|198|O|poison control center right away. US residents can call||
1140|199|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1140|200|O|Symptoms of overdose may include: burning pain in the||
1140|201|O|throat/stomach, confusion, mental/mood changes, fainting,||
1140|202|O|weakness, ringing in the ears, fever, rapid breathing, change in||
1140|203|O|the amount of urine, seizures, loss of consciousness.||
1140|204|B|||
1140|205|N|NOTES:  If you use this medication regularly or at high doses,||
1140|206|N|lab and/or medical tests (such as liver/kidney function, blood||
1140|207|N|count, salicylate level) may be done while you are taking this||
1140|208|N|medication. Keep all medical and lab appointments. Consult your||
1140|209|N|doctor for more details.||
1140|210|N|   There are many different aspirin products. Some have special||
1140|211|N|coatings and some are long-acting. Ask your doctor or pharmacist||
1140|212|N|to recommend the best product for you.||
1140|213|B|||
1140|214|D|MISSED DOSE:  If your doctor directs you to take this drug on a||
1140|215|D|regular schedule (not just "as needed") and you miss a dose, take||
1140|216|D|it as soon as you remember. If it is near the time of the next||
1140|217|D|dose, skip the missed dose. Take your next dose at the regular||
1140|218|D|time. Do not double the dose to catch up.||
1140|219|B|||
1140|220|R|STORAGE:  Store at room temperature away from moisture and light.||
1140|221|R|Do not store in the bathroom. Do not use any aspirin product that||
1140|222|R|has a strong vinegar-like smell. Keep all medications away from||
1140|223|R|children and pets.||
1140|224|R|   Do not flush medications down the toilet or pour them into a||
1140|225|R|drain unless instructed to do so. Properly discard this product||
1140|226|R|when it is expired or no longer needed. Consult your pharmacist||
1140|227|R|or local waste disposal company.||
1140|228|B|||
1140|229|A|Information last revised November 2025.||
1140|230|A|Copyright(c) 2025 First Databank, Inc.||
1140|231|B|||
1142|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1142|002|Z|does NOT have all possible information about this product. This||
1142|003|Z|information does not assure that this product is safe, effective,||
1142|004|Z|or appropriate for you. This information is not individual||
1142|005|Z|medical advice and does not substitute for the advice of your||
1142|006|Z|health care professional. Always ask your health care||
1142|007|Z|professional for complete information about this product and your||
1142|008|Z|specific health needs.||
1142|009|B|||
1142|010|T|GRANISETRON - TRANSDERMAL||
1142|011|F|(gra-NIS-e-tron)||
1142|012|B|||
1142|013|C|COMMON BRAND NAME(S): Sancuso||
1142|014|B|||
1142|015|U|USES:  This medication is used to prevent nausea and vomiting||
1142|016|U|caused by cancer drug treatment (chemotherapy). It works by||
1142|017|U|blocking one of the body's natural substances (serotonin) that||
1142|018|U|can cause vomiting.||
1142|019|B|||
1142|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1142|021|H|from your pharmacist before you start using this medication and||
1142|022|H|each time you get a refill. Follow all instructions for how to||
1142|023|H|properly apply and use the patch. Do not cut the patch into||
1142|024|H|smaller sizes. Do not use the patch if it appears broken, cut, or||
1142|025|H|damaged. If you have any questions, ask your doctor or||
1142|026|H|pharmacist.||
1142|027|H|   Apply this medication to the skin as directed by your doctor,||
1142|028|H|usually 1 to 2 days (24 to 48 hours) before your chemotherapy||
1142|029|H|treatment. Do not open the sealed pouch until you are ready to||
1142|030|H|use the patch. Open the pouch and remove the patch from the||
1142|031|H|protective liner. Apply the patch as directed to a clean and dry||
1142|032|H|area on the outside part of your upper arm. Do not apply the||
1142|033|H|patch to recently shaved or oily/red/irritated/broken areas of||
1142|034|H|skin or to areas where you have applied skin products such as||
1142|035|H|creams or lotions. You can bathe and shower with the patch on.||
1142|036|H|Wash your hands with soap and water after each application. Do||
1142|037|H|not apply a heating pad or other heat to the patch area since||
1142|038|H|this may increase the risk of side effects.||
1142|039|H|   Wear the patch during your chemotherapy treatment until at||
1142|040|H|least 24 hours after you finish treatment. Do not wear the patch||
1142|041|H|for more than 7 days in a row. Consult your doctor for more||
1142|042|H|details on how long you should wear your patch.||
1142|043|H|   If the patch does not stick well, apply medical tape or||
1142|044|H|surgical bandages to the edges of the patch to keep the patch in||
1142|045|H|place. Do not completely cover the patch.||
1142|046|H|   When it is time to remove the patch, peel it off gently. Fold||
1142|047|H|it in half with the sticky sides together, and discard in the||
1142|048|H|trash away from children and pets. Do not reuse the patch. Wash||
1142|049|H|the application site and your hands with soap and water. The||
1142|050|H|application site may have some mild redness, which should go away||
1142|051|H|within 3 days. Contact your doctor if the redness continues after||
1142|052|H|3 days.||
1142|053|H|   Use this medication exactly as directed to get the most||
1142|054|H|benefit from it. Do not use more medication than prescribed. Tell||
1142|055|H|your doctor if nausea occurs with your chemotherapy treatment.||
1142|056|B|||
1142|057|S|SIDE EFFECTS:  Constipation may occur. If this effect lasts or||
1142|058|S|gets worse, tell your doctor promptly.||
1142|059|S|   Remember that this medication has been prescribed because your||
1142|060|S|doctor has judged that the benefit to you is greater than the||
1142|061|S|risk of side effects. Many people using this medication do not||
1142|062|S|have serious side effects.||
1142|063|S|   Tell your doctor right away if you have any serious side||
1142|064|S|effects, including: stomach/abdominal pain or swelling.||
1142|065|S|   This medication may increase serotonin and rarely cause a very||
1142|066|S|serious condition called serotonin syndrome/toxicity. The risk||
1142|067|S|increases if you are also taking other drugs that increase||
1142|068|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1142|069|S|take (see Drug Interactions section). Get medical help right away||
1142|070|S|if you develop some of the following symptoms: fast heartbeat,||
1142|071|S|hallucinations, loss of coordination, severe dizziness, severe||
1142|072|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1142|073|S|unusual agitation/restlessness.||
1142|074|S|   A very serious allergic reaction to this drug is rare.||
1142|075|S|However, get medical help right away if you notice any symptoms||
1142|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1142|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1142|078|S|breathing.||
1142|079|S|   This is not a complete list of possible side effects. If you||
1142|080|S|notice other effects not listed above, contact your doctor or||
1142|081|S|pharmacist.||
1142|082|S|   In the US -||
1142|083|S|   Call your doctor for medical advice about side effects. You||
1142|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1142|085|S|www.fda.gov/medwatch.||
1142|086|S|   In Canada - Call your doctor for medical advice about side||
1142|087|S|effects. You may report side effects to Health Canada at||
1142|088|S|1-866-234-2345.||
1142|089|B|||
1142|090|P|PRECAUTIONS:  Before using granisetron, tell your doctor or||
1142|091|P|pharmacist if you are allergic to it; or if you have any other||
1142|092|P|allergies. This product may contain inactive ingredients, which||
1142|093|P|can cause allergic reactions or other problems. Talk to your||
1142|094|P|pharmacist for more details.||
1142|095|P|   Before using this medication, tell your doctor or pharmacist||
1142|096|P|your medical history, especially of: stomach/intestinal problems||
1142|097|P|(such as ileus, swelling).||
1142|098|P|   This medication may be affected by sunlight or may make the||
1142|099|P|application site more sensitive to sunlight. While wearing the||
1142|100|P|patch, keep it covered (such as under clothing) to avoid exposing||
1142|101|P|it to sunlight and sunlamps. Avoid tanning booths. After removing||
1142|102|P|the patch, keep the application site covered for another 10 days.||
1142|103|P|Tell your doctor right away if you get sunburned or have skin||
1142|104|P|blisters/redness.||
1142|105|P|   If you are going to have an MRI test, tell testing personnel||
1142|106|P|that you are using this patch. Some patches may contain metals||
1142|107|P|that can cause serious burns during an MRI. Ask your doctor||
1142|108|P|whether you will need to remove your patch before the test and||
1142|109|P|apply a new patch afterward, and how to do so properly.||
1142|110|P|   Before having surgery, tell your doctor or dentist about all||
1142|111|P|the products you use (including prescription drugs,||
1142|112|P|nonprescription drugs, and herbal products).||
1142|113|P|   During pregnancy, this medication should be used only when||
1142|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
1142|115|P|   It is unknown if this medication passes into breast milk.||
1142|116|P|Consult your doctor before breastfeeding.||
1142|117|B|||
1142|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1142|119|I|medications work or increase your risk for serious side effects.||
1142|120|I|This document does not contain all possible drug interactions.||
1142|121|I|Keep a list of all the products you use (including||
1142|122|I|prescription/nonprescription drugs and herbal products) and share||
1142|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
1142|124|I|the dosage of any medicines without your doctor's approval.||
1142|125|I|   A product that may interact with this drug is: apomorphine.||
1142|126|I|   The risk of serotonin syndrome/toxicity increases if you are||
1142|127|I|also taking other drugs that increase serotonin. Examples include||
1142|128|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1142|129|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1142|130|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1142|131|I|serotonin syndrome/toxicity may be more likely when you start or||
1142|132|I|increase the dose of these drugs.||
1142|133|B|||
1142|134|O|OVERDOSE:  This medication patch may be harmful if chewed or||
1142|135|O|swallowed. If someone has overdosed, remove the patch if||
1142|136|O|possible. For serious symptoms such as passing out or trouble||
1142|137|O|breathing, call 911. Otherwise, call a poison control center||
1142|138|O|right away. US residents can call 1-800-222-1222. Canada||
1142|139|O|residents can call 1-844-764-7669.||
1142|140|B|||
1142|141|N|NOTES:  Do not share this medication with others.||
1142|142|B|||
1142|143|D|MISSED DOSE:  Tell your doctor if you miss your dose or did not||
1142|144|D|use your dose at the correct time before your scheduled||
1142|145|D|chemotherapy appointment. Your treatment may need to be||
1142|146|D|rescheduled.||
1142|147|B|||
1142|148|R|STORAGE:  Store the patch at room temperature away from heat. Do||
1142|149|R|not open the pouch until you are ready to use the patch. Keep all||
1142|150|R|medications away from children and pets.||
1142|151|R|   Do not flush medications down the toilet or pour them into a||
1142|152|R|drain unless instructed to do so. Properly discard this product||
1142|153|R|when it is expired or no longer needed. Consult your pharmacist||
1142|154|R|or local waste disposal company.||
1142|155|B|||
1142|156|A|Information last revised July 2024.||
1142|157|A|Copyright(c) 2025 First Databank, Inc.||
1142|158|B|||
1144|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1144|002|Z|does NOT have all possible information about this product. This||
1144|003|Z|information does not assure that this product is safe, effective,||
1144|004|Z|or appropriate for you. This information is not individual||
1144|005|Z|medical advice and does not substitute for the advice of your||
1144|006|Z|health care professional. Always ask your health care||
1144|007|Z|professional for complete information about this product and your||
1144|008|Z|specific health needs.||
1144|009|B|||
1144|010|T|DEXTROMETHORPHAN/ACETAMINOPHEN/ANTIHISTAMINE - ORAL||
1144|011|B|||
1144|012|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
1144|013|W|too much acetaminophen may cause serious (possibly fatal) liver||
1144|014|W|disease. Adults should not take more than 4000 milligrams (4||
1144|015|W|grams) of acetaminophen a day. People with liver problems and||
1144|016|W|children should take less acetaminophen. Ask your doctor or||
1144|017|W|pharmacist how much acetaminophen is safe to take.||
1144|018|W|   Do not use with any other drug containing acetaminophen||
1144|019|W|without asking your doctor or pharmacist first. Acetaminophen is||
1144|020|W|in many nonprescription and prescription medications (such as||
1144|021|W|pain/fever drugs or cough-and-cold products). Check the labels on||
1144|022|W|all your medicines to see if they contain acetaminophen, and ask||
1144|023|W|your pharmacist if you are unsure.||
1144|024|W|   Get medical help right away if you take too much acetaminophen||
1144|025|W|(overdose), even if you feel well. Overdose symptoms may include||
1144|026|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
1144|027|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
1144|028|W|   Daily alcohol use, especially when combined with||
1144|029|W|acetaminophen, may damage your liver. Avoid alcohol||
1144|030|B|||
1144|031|U|USES:  This combination medication is used to temporarily treat||
1144|032|U|symptoms caused by the common cold, flu, allergies, or other||
1144|033|U|breathing illnesses (such as sinusitis, bronchitis).||
1144|034|U|Dextromethorphan is a cough suppressant that affects a certain||
1144|035|U|part of the brain, reducing the urge to cough. Acetaminophen||
1144|036|U|(APAP) is a non-aspirin pain reliever and fever reducer.||
1144|037|U|Antihistamines help relieve watery eyes, itchy eyes/nose/throat,||
1144|038|U|runny nose, and sneezing.||
1144|039|U|   This medication is not usually used for ongoing coughs from||
1144|040|U|smoking, asthma, or other long-term breathing problems (such as||
1144|041|U|emphysema), or for coughs with a lot of mucus, unless directed by||
1144|042|U|your doctor.||
1144|043|U|   Cough-and-cold products have not been shown to be safe or||
1144|044|U|effective in children younger than 6 years. Do not use this||
1144|045|U|product to treat cold symptoms in children younger than 6 years||
1144|046|U|unless specifically directed by the doctor. Some products (such||
1144|047|U|as long-acting tablets/capsules) are not recommended for use in||
1144|048|U|children younger than 12 years. Ask your doctor or pharmacist for||
1144|049|U|more details about using your product safely.||
1144|050|U|   These products do not cure or shorten the length of the common||
1144|051|U|cold and may cause serious side effects. To decrease the risk for||
1144|052|U|serious side effects, carefully follow all dosage directions. Do||
1144|053|U|not use this product to make a child sleepy. Do not give other||
1144|054|U|cough-and-cold medication that might contain the same or similar||
1144|055|U|ingredients (see also Drug Interactions section). Ask the doctor||
1144|056|U|or pharmacist about other ways to relieve cough and cold symptoms||
1144|057|U|(such as drinking enough fluids, using a humidifier or saline||
1144|058|U|nose drops/spray).||
1144|059|B|||
1144|060|H|HOW TO USE:  See also Warning section.||
1144|061|H|   Read and follow all directions on the package label. Do not||
1144|062|H|give children medicines labeled only for adults. If you have any||
1144|063|H|questions, consult your pharmacist.||
1144|064|H|   Take this medication by mouth with or without food, usually||
1144|065|H|every 4 to 6 hours as needed or as directed by your doctor. If||
1144|066|H|stomach upset occurs, it may help to take this medication with||
1144|067|H|food or milk. Drink plenty of fluids when you use this medication||
1144|068|H|unless otherwise directed by your doctor. The fluid will help||
1144|069|H|loosen the mucus in your lungs.||
1144|070|H|   If you are using the liquid form of this medication, carefully||
1144|071|H|measure the dose using a special measuring device/spoon. Do not||
1144|072|H|use a household spoon because you may not get the correct dose.||
1144|073|H|If your liquid form is a suspension, shake the bottle well before||
1144|074|H|each dose.||
1144|075|H|   If you are using the powder form, dissolve the contents of||
1144|076|H|each packet in 8 ounces (240 milliliters) of water as directed on||
1144|077|H|the product package. Drink within 10 to 15 minutes of mixing.||
1144|078|H|   The dosage is based on your age, medical condition, and||
1144|079|H|response to treatment. Do not increase your dose, take it more||
1144|080|H|often, or use it for a longer time than directed. Improper use||
1144|081|H|(abuse) of this medication may result in serious harm (including||
1144|082|H|brain damage, seizure, death).||
1144|083|H|   Tell your doctor if your condition lasts for more than 1 week,||
1144|084|H|if it gets worse, or if it occurs with a headache that doesn't go||
1144|085|H|away, rash, or fever lasting more than 3 days. These may be||
1144|086|H|symptoms of a serious medical problem and should be checked by a||
1144|087|H|doctor.||
1144|088|B|||
1144|089|S|SIDE EFFECTS:  See also Warning section.||
1144|090|S|   Drowsiness, dizziness, blurred vision, upset stomach, nausea,||
1144|091|S|constipation, or dry mouth/nose/throat may occur. If any of these||
1144|092|S|effects last or get worse, tell your doctor or pharmacist||
1144|093|S|promptly.||
1144|094|S|   If your doctor has directed you to use this medication,||
1144|095|S|remember that your doctor has judged that the benefit to you is||
1144|096|S|greater than the risk of side effects. Many people using this||
1144|097|S|medication do not have serious side effects.||
1144|098|S|   Tell your doctor right away if you have any serious side||
1144|099|S|effects, including: mental/mood changes (such as confusion,||
1144|100|S|hallucinations), trouble urinating, fast/irregular heartbeat,||
1144|101|S|seizure.||
1144|102|S|   A very serious allergic reaction to this drug is rare.||
1144|103|S|However, get medical help right away if you notice any symptoms||
1144|104|S|of a serious allergic reaction, including: rash, itching/swelling||
1144|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1144|106|S|breathing.||
1144|107|S|   This is not a complete list of possible side effects. If you||
1144|108|S|notice other effects not listed above, contact your doctor or||
1144|109|S|pharmacist.||
1144|110|S|   In the US -||
1144|111|S|   Call your doctor for medical advice about side effects. You||
1144|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1144|113|S|www.fda.gov/medwatch.||
1144|114|S|   In Canada - Call your doctor for medical advice about side||
1144|115|S|effects. You may report side effects to Health Canada at||
1144|116|S|1-866-234-2345.||
1144|117|B|||
1144|118|P|PRECAUTIONS:  See also Warning section.||
1144|119|P|   Before taking this product, tell your doctor or pharmacist if||
1144|120|P|you are allergic to any of its ingredients; or if you have any||
1144|121|P|other allergies. This product may contain inactive ingredients,||
1144|122|P|which can cause allergic reactions or other problems. Talk to||
1144|123|P|your pharmacist for more details.||
1144|124|P|   If you have any of the following health problems, consult your||
1144|125|P|doctor or pharmacist before using this medication: breathing||
1144|126|P|problems (such as asthma, emphysema), diabetes, glaucoma, heart||
1144|127|P|problems, high blood pressure, kidney problems, liver disease,||
1144|128|P|seizures, stomach/intestinal problems (such as blockage,||
1144|129|P|constipation, ulcers), overactive thyroid (hyperthyroidism),||
1144|130|P|urination problems (such as trouble urinating due to enlarged||
1144|131|P|prostate, urinary retention).||
1144|132|P|   This drug may make you dizzy or drowsy or blur your vision.||
1144|133|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1144|134|P|drowsy. Do not drive, use machinery, or do anything that needs||
1144|135|P|alertness or clear vision until you can do it safely. Avoid||
1144|136|P|alcoholic beverages. Talk to your doctor if you are using||
1144|137|P|marijuana (cannabis).||
1144|138|P|   Some brands of this product may contain sugar, alcohol, or||
1144|139|P|aspartame. Caution is advised if you have diabetes, alcohol||
1144|140|P|dependence, liver disease, phenylketonuria (PKU), or any other||
1144|141|P|condition that requires you to limit/avoid these substances in||
1144|142|P|your diet. Ask your doctor or pharmacist about using this product||
1144|143|P|safely.||
1144|144|P|   Before having surgery, tell your doctor or dentist about all||
1144|145|P|the products you use (including prescription drugs,||
1144|146|P|nonprescription drugs, and herbal products).||
1144|147|P|   Children may be more sensitive to the side effects of this||
1144|148|P|drug. In young children, antihistamines may cause||
1144|149|P|agitation/excitement instead of drowsiness.||
1144|150|P|   Older adults may be more sensitive to the side effects of this||
1144|151|P|drug, especially dizziness, drowsiness, constipation, trouble||
1144|152|P|urinating, or mental/mood changes. Dizziness, drowsiness, and||
1144|153|P|confusion can increase the risk of falling.||
1144|154|P|   During pregnancy, this medication should be used only when||
1144|155|P|clearly needed. Discuss the risks and benefits with your doctor.||
1144|156|P|   This medication may pass into breast milk and may have||
1144|157|P|undesirable effects on a nursing infant. Consult your doctor||
1144|158|P|before breastfeeding.||
1144|159|B|||
1144|160|I|DRUG INTERACTIONS:  See also Warning section.||
1144|161|I|   Drug interactions may change how your medications work or||
1144|162|I|increase your risk for serious side effects. This document does||
1144|163|I|not contain all possible drug interactions. Keep a list of all||
1144|164|I|the products you use (including prescription/nonprescription||
1144|165|I|drugs and herbal products) and share it with your doctor and||
1144|166|I|pharmacist. Do not start, stop, or change the dosage of any||
1144|167|I|medicines without your doctor's approval.||
1144|168|I|   Some products that may interact with this drug are:||
1144|169|I|antihistamines applied to the skin (such as diphenhydramine||
1144|170|I|cream, ointment, spray), ketoconazole, levoketoconazole,||
1144|171|I|rolapitant.||
1144|172|I|   Taking certain MAO inhibitors with this medication may cause a||
1144|173|I|serious (possibly fatal) drug interaction. Avoid taking||
1144|174|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
1144|175|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
1144|176|I|tranylcypromine during treatment with this medication. Most MAO||
1144|177|I|inhibitors should also not be taken for two weeks before||
1144|178|I|treatment with this medication. Ask your doctor when to start or||
1144|179|I|stop taking this medication.||
1144|180|I|   Tell your doctor or pharmacist if you are taking other||
1144|181|I|products that cause drowsiness such as opioid pain or cough||
1144|182|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1144|183|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1144|184|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1144|185|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1144|186|I|diphenhydramine).||
1144|187|I|   The ingredients in this product are available in many||
1144|188|I|prescription and nonprescription products. Check the labels on||
1144|189|I|all your medicines (such as pain/fever drugs, diet aids, or||
1144|190|I|cough-and-cold/allergy products) because they may contain the||
1144|191|I|same or similar ingredients. Using these drugs along with this||
1144|192|I|product could increase side effects. Ask your pharmacist about||
1144|193|I|using those products safely.||
1144|194|I|   This medication may interfere with certain lab tests (such as||
1144|195|I|urine drug screening tests, urine 5-HIAA, allergy skin test),||
1144|196|I|possibly causing false test results. Make sure lab personnel and||
1144|197|I|all your doctors know you use this drug.||
1144|198|B|||
1144|199|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1144|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1144|201|O|poison control center right away. US residents can call||
1144|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1144|203|O|Symptoms of overdose may include: nausea, vomiting, loss of||
1144|204|O|appetite, sweating, stomach/abdominal pain, extreme tiredness,||
1144|205|O|agitation, confusion, flushing, hallucinations, yellowing||
1144|206|O|eyes/skin, dark urine, seizures. In children, excitement may||
1144|207|O|occur first, and may be followed by: loss of coordination,||
1144|208|O|drowsiness, loss of consciousness, seizures.||
1144|209|B|||
1144|210|N|NOTES:  Keep all medical and lab appointments.||
1144|211|B|||
1144|212|D|MISSED DOSE:  If you are taking this product on a regular||
1144|213|D|schedule and miss a dose, take it as soon as you remember. If it||
1144|214|D|is near the time of the next dose, skip the missed dose. Take||
1144|215|D|your next dose at the regular time. Do not double the dose to||
1144|216|D|catch up.||
1144|217|B|||
1144|218|R|STORAGE:  Store at room temperature away from light and moisture.||
1144|219|R|Do not store in the bathroom. Do not freeze liquid forms of this||
1144|220|R|medication. Keep all medications away from children and pets.||
1144|221|R|   Do not flush medications down the toilet or pour them into a||
1144|222|R|drain unless instructed to do so. Properly discard this product||
1144|223|R|when it is expired or no longer needed. Consult your pharmacist||
1144|224|R|or local waste disposal company.||
1144|225|B|||
1144|226|A|Information last revised May 2025.||
1144|227|A|Copyright(c) 2025 First Databank, Inc.||
1144|228|B|||
1145|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1145|002|Z|does NOT have all possible information about this product. This||
1145|003|Z|information does not assure that this product is safe, effective,||
1145|004|Z|or appropriate for you. This information is not individual||
1145|005|Z|medical advice and does not substitute for the advice of your||
1145|006|Z|health care professional. Always ask your health care||
1145|007|Z|professional for complete information about this product and your||
1145|008|Z|specific health needs.||
1145|009|B|||
1145|010|T|EXPECTORANT/DECONGESTANT/ACETAMINOPHEN - ORAL||
1145|011|B|||
1145|012|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
1145|013|W|too much acetaminophen may cause serious (possibly fatal) liver||
1145|014|W|disease. Adults should not take more than 4000 milligrams (4||
1145|015|W|grams) of acetaminophen a day. People with liver problems and||
1145|016|W|children should take less acetaminophen. Ask your doctor or||
1145|017|W|pharmacist how much acetaminophen is safe to take.||
1145|018|W|   Do not use with any other drug containing acetaminophen||
1145|019|W|without asking your doctor or pharmacist first. Acetaminophen is||
1145|020|W|in many nonprescription and prescription medications (such as||
1145|021|W|pain/fever drugs or cough-and-cold products). Check the labels on||
1145|022|W|all your medicines to see if they contain acetaminophen, and ask||
1145|023|W|your pharmacist if you are unsure.||
1145|024|W|   Get medical help right away if you take too much acetaminophen||
1145|025|W|(overdose), even if you feel well. Overdose symptoms may include||
1145|026|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
1145|027|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
1145|028|W|   Daily alcohol use, especially when combined with||
1145|029|W|acetaminophen, may damage your liver. Avoid alcohol.||
1145|030|B|||
1145|031|U|USES:  This combination medication is used to temporarily treat||
1145|032|U|symptoms caused by the common cold, flu, allergies, or other||
1145|033|U|breathing illnesses (such as sinusitis, bronchitis). The||
1145|034|U|expectorant helps thin and loosen mucus in the lungs, making it||
1145|035|U|easier to cough up the mucus. Decongestants help relieve stuffy||
1145|036|U|nose, sinus, and ear congestion symptoms. Acetaminophen (APAP) is||
1145|037|U|a non-aspirin pain reliever and fever reducer.||
1145|038|U|   This medication is not usually used for ongoing coughs from||
1145|039|U|smoking, asthma, other long-term breathing problems (such as||
1145|040|U|emphysema), or coughs with a lot of mucus unless directed by your||
1145|041|U|doctor.||
1145|042|U|   Cough-and-cold products have not been shown to be safe or||
1145|043|U|effective in children younger than 6 years. Do not use this||
1145|044|U|product to treat cold symptoms in children younger than 6 years||
1145|045|U|unless specifically directed by the doctor. Some products (such||
1145|046|U|as long-acting tablets/capsules) are not recommended for use in||
1145|047|U|children younger than 12 years. Ask your doctor or pharmacist for||
1145|048|U|more details about using your product safely.||
1145|049|U|   These products do not cure or shorten the length of the common||
1145|050|U|cold and may cause serious side effects. To decrease the risk for||
1145|051|U|serious side effects, carefully follow all dosage directions. Do||
1145|052|U|not use this product to make a child sleepy. Do not give other||
1145|053|U|cough-and-cold medication that might contain the same or similar||
1145|054|U|ingredients (see also Drug Interactions section). Ask the doctor||
1145|055|U|or pharmacist about other ways to relieve cough and cold symptoms||
1145|056|U|(such as drinking enough fluids, using a humidifier or saline||
1145|057|U|nose drops/spray).||
1145|058|B|||
1145|059|H|HOW TO USE:  See also Warning section.||
1145|060|H|   Read and follow all directions on the package label. If you||
1145|061|H|have any questions, consult your pharmacist.||
1145|062|H|   Take this medication by mouth with or without food, usually||
1145|063|H|every 4 to 6 hours as needed or as directed by your doctor. Drink||
1145|064|H|plenty of fluids when you use this medication unless otherwise||
1145|065|H|directed by your doctor. The fluid will help loosen the mucus in||
1145|066|H|your lungs.||
1145|067|H|   If you are using the liquid form of this medication, carefully||
1145|068|H|measure the dose using a special measuring device/spoon. Do not||
1145|069|H|use a household spoon because you may not get the correct dose.||
1145|070|H|If your liquid form is a suspension, shake the bottle well before||
1145|071|H|each dose.||
1145|072|H|   The dosage is based on your age, medical condition, and||
1145|073|H|response to treatment. Do not increase your dose, take it more||
1145|074|H|often, or use it for a longer time than directed. Do not give||
1145|075|H|children medicines labeled only for adults.||
1145|076|H|   Tell your doctor if your condition lasts for more than 1 week,||
1145|077|H|if it gets worse, or if it occurs with a headache that doesn't go||
1145|078|H|away, rash, or fever lasting more than 3 days. These may be||
1145|079|H|symptoms of a serious medical problem and should be checked by a||
1145|080|H|doctor.||
1145|081|B|||
1145|082|S|SIDE EFFECTS:  See also Warning section.||
1145|083|S|   Upset stomach, nausea, dizziness, trouble sleeping, or||
1145|084|S|nervousness may occur. If any of these effects last or get worse,||
1145|085|S|tell your doctor or pharmacist promptly.||
1145|086|S|   If your doctor has directed you to use this medication,||
1145|087|S|remember that your doctor has judged that the benefit to you is||
1145|088|S|greater than the risk of side effects. Many people using this||
1145|089|S|medication do not have serious side effects.||
1145|090|S|   This medication may raise your blood pressure. Check your||
1145|091|S|blood pressure regularly and tell your doctor if the results are||
1145|092|S|high.||
1145|093|S|   Tell your doctor right away if you have any serious side||
1145|094|S|effects, including: mental/mood changes (such as confusion,||
1145|095|S|hallucinations), fast/irregular heartbeat, problems urinating.||
1145|096|S|   A very serious allergic reaction to this drug is rare.||
1145|097|S|However, get medical help right away if you notice any symptoms||
1145|098|S|of a serious allergic reaction, including: rash, itching/swelling||
1145|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1145|100|S|breathing.||
1145|101|S|   This is not a complete list of possible side effects. If you||
1145|102|S|notice other effects not listed above, contact your doctor or||
1145|103|S|pharmacist.||
1145|104|S|   In the US -||
1145|105|S|   Call your doctor for medical advice about side effects. You||
1145|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1145|107|S|www.fda.gov/medwatch.||
1145|108|S|   In Canada - Call your doctor for medical advice about side||
1145|109|S|effects. You may report side effects to Health Canada at||
1145|110|S|1-866-234-2345.||
1145|111|B|||
1145|112|P|PRECAUTIONS:  See also Warning section.||
1145|113|P|   Before taking this product, tell your doctor or pharmacist if||
1145|114|P|you are allergic to any of its ingredients; or if you have any||
1145|115|P|other allergies. This product may contain inactive ingredients,||
1145|116|P|which can cause allergic reactions or other problems. Talk to||
1145|117|P|your pharmacist for more details.||
1145|118|P|   If you have any of the following health problems, consult your||
1145|119|P|doctor or pharmacist before using this medication: breathing||
1145|120|P|problems (such as asthma, emphysema), diabetes, glaucoma, heart||
1145|121|P|problems, high blood pressure, liver disease, kidney problems,||
1145|122|P|overactive thyroid (hyperthyroidism), urination problems (such as||
1145|123|P|trouble urinating due to enlarged prostate, urinary retention).||
1145|124|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1145|125|P|can make you more dizzy. Do not drive, use machinery, or do||
1145|126|P|anything that needs alertness until you can do it safely. Avoid||
1145|127|P|alcoholic beverages. Talk to your doctor if you are using||
1145|128|P|marijuana (cannabis).||
1145|129|P|   Some brands of this product may contain sugar, alcohol, or||
1145|130|P|aspartame. Caution is advised if you have diabetes, alcohol||
1145|131|P|dependence, liver disease, phenylketonuria (PKU) or any other||
1145|132|P|condition that requires you to limit/avoid these substances in||
1145|133|P|your diet. Ask your doctor or pharmacist about using this product||
1145|134|P|safely.||
1145|135|P|   Before having surgery, tell your doctor or dentist about all||
1145|136|P|the products you use (including prescription drugs,||
1145|137|P|nonprescription drugs, and herbal products).||
1145|138|P|   Infants or children may be more sensitive to the side effects||
1145|139|P|of this drug, especially excitation and agitation.||
1145|140|P|   Older adults may be more sensitive to the side effects of this||
1145|141|P|drug, especially fast/irregular heartbeat, dizziness, problems||
1145|142|P|urinating, trouble sleeping, or confusion.||
1145|143|P|   During pregnancy, this medication should be used only when||
1145|144|P|clearly needed. Discuss the risks and benefits with your doctor.||
1145|145|P|   This medication may pass into breast milk. Consult your doctor||
1145|146|P|before breastfeeding.||
1145|147|B|||
1145|148|I|DRUG INTERACTIONS:  See also Warning section.||
1145|149|I|   Drug interactions may change how your medications work or||
1145|150|I|increase your risk for serious side effects. This document does||
1145|151|I|not contain all possible drug interactions. Keep a list of all||
1145|152|I|the products you use (including prescription/nonprescription||
1145|153|I|drugs and herbal products) and share it with your doctor and||
1145|154|I|pharmacist. Do not start, stop, or change the dosage of any||
1145|155|I|medicines without your doctor's approval.||
1145|156|I|   Some products that may interact with this drug are:||
1145|157|I|ketoconazole, levoketoconazole.||
1145|158|I|   Taking MAO inhibitors with this medication may cause a serious||
1145|159|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1145|160|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1145|161|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1145|162|I|selegiline, tranylcypromine) during treatment with this||
1145|163|I|medication. Most MAO inhibitors should also not be taken for two||
1145|164|I|weeks before treatment with this medication. Ask your doctor when||
1145|165|I|to start or stop taking this medication.||
1145|166|I|   The ingredients in this product are available in many||
1145|167|I|prescription and nonprescription products. Check the labels on||
1145|168|I|all your medicines (such as pain/fever drugs, diet aids, or||
1145|169|I|cold/allergy products) because they may contain the same or||
1145|170|I|similar ingredients. Using these drugs along with this product||
1145|171|I|could increase side effects (such as fast heartbeat or increased||
1145|172|I|blood pressure). Ask your pharmacist about using those products||
1145|173|I|safely.||
1145|174|I|   This medication may interfere with certain lab tests (such as||
1145|175|I|urine 5-HIAA), possibly causing false test results. Make sure lab||
1145|176|I|personnel and all your doctors know you use this drug.||
1145|177|B|||
1145|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1145|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1145|180|O|poison control center right away. US residents can call||
1145|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1145|182|O|Symptoms of overdose may include: fast/irregular heartbeat,||
1145|183|O|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
1145|184|O|pain, extreme tiredness, yellowing eyes/skin, dark urine,||
1145|185|O|hallucinations, seizures.||
1145|186|B|||
1145|187|N|NOTES:  Keep all medical and lab appointments.||
1145|188|B|||
1145|189|D|MISSED DOSE:  If you are taking this product on a regular||
1145|190|D|schedule and miss a dose, take it as soon as you remember. If it||
1145|191|D|is near the time of the next dose, skip the missed dose. Take||
1145|192|D|your next dose at the regular time. Do not double the dose to||
1145|193|D|catch up.||
1145|194|B|||
1145|195|R|STORAGE:  Store at room temperature away from light and moisture.||
1145|196|R|Do not store in the bathroom. Keep all medications away from||
1145|197|R|children and pets.||
1145|198|R|   Do not flush medications down the toilet or pour them into a||
1145|199|R|drain unless instructed to do so. Properly discard this product||
1145|200|R|when it is expired or no longer needed. Consult your pharmacist||
1145|201|R|or local waste disposal company.||
1145|202|B|||
1145|203|A|Information last revised July 2025.||
1145|204|A|Copyright(c) 2025 First Databank, Inc.||
1145|205|B|||
1148|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1148|002|Z|does NOT have all possible information about this product. This||
1148|003|Z|information does not assure that this product is safe, effective,||
1148|004|Z|or appropriate for you. This information is not individual||
1148|005|Z|medical advice and does not substitute for the advice of your||
1148|006|Z|health care professional. Always ask your health care||
1148|007|Z|professional for complete information about this product and your||
1148|008|Z|specific health needs.||
1148|009|B|||
1148|010|T|DAPSONE GEL - TOPICAL||
1148|011|F|(DAP-sone)||
1148|012|B|||
1148|013|C|COMMON BRAND NAME(S): Aczone||
1148|014|B|||
1148|015|U|USES:  This medication is used to treat acne. It helps decrease||
1148|016|U|the number and severity of acne pimples and helps pimples that do||
1148|017|U|develop to heal more quickly. Dapsone is an antibiotic. It is not||
1148|018|U|known how dapsone works to treat acne.||
1148|019|B|||
1148|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1148|021|H|from your pharmacist before you start using dapsone and each time||
1148|022|H|you get a refill. If you have any questions, ask your doctor or||
1148|023|H|pharmacist.||
1148|024|H|   Wash your hands before and after applying this medication.||
1148|025|H|Gently clean the affected skin with a mild/soapless cleanser and||
1148|026|H|pat dry. Apply a small amount of medication (about the size of a||
1148|027|H|pea) in a thin layer to the affected areas of skin as directed by||
1148|028|H|your doctor. Depending on your brand, this medication is usually||
1148|029|H|used once or twice a day. Rub in gently. Be careful to avoid the||
1148|030|H|eyes and lip area.||
1148|031|H|   Use this medication on the skin only. Do not apply to the||
1148|032|H|inside of the mouth/nose or in or around the groin/vaginal area.||
1148|033|H|   Avoid getting this medication in your eyes. If this occurs,||
1148|034|H|flush with large amounts of water. Call your doctor if eye||
1148|035|H|irritation develops. Wash your hands after using the medication||
1148|036|H|to avoid accidentally getting it in your eyes.||
1148|037|H|   Use this product regularly to get the most benefit from it. To||
1148|038|H|help you remember, use it at the same time(s) each day. Do not||
1148|039|H|use a larger amount or use it more often than directed. Your skin||
1148|040|H|will not improve any faster and you may have a greater risk of||
1148|041|H|side effects.||
1148|042|H|   Tell your doctor if your condition does not get better or if||
1148|043|H|it gets worse after 12 weeks.||
1148|044|B|||
1148|045|S|SIDE EFFECTS:  Skin redness, peeling, oiliness, or dryness may||
1148|046|S|occur. If any of these effects last or get worse, tell your||
1148|047|S|doctor or pharmacist promptly.||
1148|048|S|   Remember that this medication has been prescribed because your||
1148|049|S|doctor has judged that the benefit to you is greater than the||
1148|050|S|risk of side effects. Many people using this medication do not||
1148|051|S|have serious side effects.||
1148|052|S|   Tell your doctor right away if you have any serious side||
1148|053|S|effects, including: mental/mood changes (such as depression,||
1148|054|S|agitation), unusual tiredness/weakness, dark urine, shortness of||
1148|055|S|breath.||
1148|056|S|   Get medical help right away if you have any very serious side||
1148|057|S|effects, including: blue/grey lips or nails.||
1148|058|S|   A very serious allergic reaction to this drug is rare.||
1148|059|S|However, get medical help right away if you notice any symptoms||
1148|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1148|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1148|062|S|breathing.||
1148|063|S|   This is not a complete list of possible side effects. If you||
1148|064|S|notice other effects not listed above, contact your doctor or||
1148|065|S|pharmacist.||
1148|066|S|   In the US -||
1148|067|S|   Call your doctor for medical advice about side effects. You||
1148|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1148|069|S|www.fda.gov/medwatch.||
1148|070|S|   In Canada - Call your doctor for medical advice about side||
1148|071|S|effects. You may report side effects to Health Canada at||
1148|072|S|1-866-234-2345.||
1148|073|B|||
1148|074|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1148|075|P|pharmacist if you are allergic to dapsone; or if you have any||
1148|076|P|other allergies. This product may contain inactive ingredients,||
1148|077|P|which can cause allergic reactions or other problems. Talk to||
1148|078|P|your pharmacist for more details.||
1148|079|P|   Before using this medication, tell your doctor or pharmacist||
1148|080|P|your medical history, especially of: a certain enzyme deficiency||
1148|081|P|(G6PD deficiency), a certain blood disorder (methemoglobinemia).||
1148|082|P|   Before having surgery, tell your doctor or dentist about all||
1148|083|P|the products you use (including prescription drugs,||
1148|084|P|nonprescription drugs, and herbal products).||
1148|085|P|   During pregnancy, this medication should be used only when||
1148|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
1148|087|P|   Dapsone passes into breast milk. Consult your doctor before||
1148|088|P|breastfeeding.||
1148|089|B|||
1148|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1148|091|I|medications work or increase your risk for serious side effects.||
1148|092|I|This document does not contain all possible drug interactions.||
1148|093|I|Keep a list of all the products you use (including||
1148|094|I|prescription/nonprescription drugs and herbal products) and share||
1148|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
1148|096|I|the dosage of any medicines without your doctor's approval.||
1148|097|I|   Some products that may interact with this drug include:||
1148|098|I|dapsone taken by mouth, drugs to treat malaria (such as||
1148|099|I|chloroquine), trimethoprim/sulfamethoxazole.||
1148|100|I|   Benzoyl peroxide is a commonly used medication for acne. Using||
1148|101|I|benzoyl peroxide at the same time as dapsone gel may cause your||
1148|102|I|skin to temporarily change color (yellow/orange). Talk with your||
1148|103|I|doctor or pharmacist and ask if you should be using prescription||
1148|104|I|or non-prescription benzoyl peroxide products and how to use them||
1148|105|I|safely.||
1148|106|B|||
1148|107|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1148|108|O|has overdosed and has serious symptoms such as passing out or||
1148|109|O|trouble breathing, call 911. Otherwise, call a poison control||
1148|110|O|center right away. US residents can call 1-800-222-1222. Canada||
1148|111|O|residents can call 1-844-764-7669.||
1148|112|B|||
1148|113|N|NOTES:  Do not share this medication with others.||
1148|114|N|   Some cosmetics and soaps may worsen your acne. Moisturizers||
1148|115|N|may be safe to use. When buying cosmetics, moisturizers, or other||
1148|116|N|skin care products, check the label for "non-comedogenic" or||
1148|117|N|"non-acnegenic." These products are unlikely to worsen your acne.||
1148|118|N|Ask your doctor or pharmacist which products are safe to use.||
1148|119|N|Remember, acne is not caused by dirt. Cleaning your skin too||
1148|120|N|often or too vigorously can irritate your skin and worsen acne.||
1148|121|B|||
1148|122|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1148|123|D|If it is near the time of the next dose, skip the missed dose.||
1148|124|D|Use your next dose at the regular time. Do not double the dose to||
1148|125|D|catch up.||
1148|126|B|||
1148|127|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
1148|128|R|medications away from children and pets.||
1148|129|R|   Do not flush medications down the toilet or pour them into a||
1148|130|R|drain unless instructed to do so. Properly discard this product||
1148|131|R|when it is expired or no longer needed. Consult your pharmacist||
1148|132|R|or local waste disposal company.||
1148|133|B|||
1148|134|A|Information last revised May 2024.||
1148|135|A|Copyright(c) 2025 First Databank, Inc.||
1148|136|B|||
1150|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1150|002|Z|does NOT have all possible information about this product. This||
1150|003|Z|information does not assure that this product is safe, effective,||
1150|004|Z|or appropriate for you. This information is not individual||
1150|005|Z|medical advice and does not substitute for the advice of your||
1150|006|Z|health care professional. Always ask your health care||
1150|007|Z|professional for complete information about this product and your||
1150|008|Z|specific health needs.||
1150|009|B|||
1150|010|T|CEFTOBIPROLE - INJECTION||
1150|011|F|(SEF-toe-BYE-prole)||
1150|012|B|||
1150|013|C|COMMON BRAND NAME(S): Zevtera||
1150|014|B|||
1150|015|U|USES:  Ceftobiprole is used to treat a variety of bacterial||
1150|016|U|infections. This medication is known as a cephalosporin||
1150|017|U|antibiotic. It works by stopping the growth of bacteria.||
1150|018|B|||
1150|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1150|020|H|from your health care professional before you start using||
1150|021|H|ceftobiprole. If you have any questions, ask your doctor or||
1150|022|H|pharmacist.||
1150|023|H|   This medication is given by injection into a vein as directed||
1150|024|H|by your doctor, usually every 8 hours. It is injected slowly into||
1150|025|H|a vein over 2 hours. The dosage is based on your medical||
1150|026|H|condition and response to treatment. Children's dosage is also||
1150|027|H|based on weight and age.||
1150|028|H|   For the best effect, use this antibiotic at evenly spaced||
1150|029|H|times. To help you remember, use this medication at the same||
1150|030|H|times every day.||
1150|031|H|   If you are using this medication at home, learn all||
1150|032|H|preparation and usage instructions from your health care||
1150|033|H|professional. Before using, check this product for particles or||
1150|034|H|discoloration. If either is present, do not use the liquid. Learn||
1150|035|H|how to store and discard medical supplies safely.||
1150|036|H|   Continue to use this medication until the full prescribed||
1150|037|H|amount is finished, even if symptoms disappear after a few days.||
1150|038|H|Stopping the medication too early may result in a return of the||
1150|039|H|infection.||
1150|040|H|   Tell your doctor if your condition lasts or gets worse.||
1150|041|B|||
1150|042|S|SIDE EFFECTS:  Pain, redness, and swelling at the injection site||
1150|043|S|may occur. Nausea, vomiting, diarrhea, unusual taste, and||
1150|044|S|headache may also occur. If any of these effects last or get||
1150|045|S|worse, tell your doctor or pharmacist promptly.||
1150|046|S|   Remember that this medication has been prescribed because your||
1150|047|S|doctor has judged that the benefit to you is greater than the||
1150|048|S|risk of side effects. Many people using this medication do not||
1150|049|S|have serious side effects.||
1150|050|S|   This medication may rarely cause a severe intestinal condition||
1150|051|S|due to a bacteria called C. difficile. This condition may occur||
1150|052|S|during treatment or weeks to months after treatment has stopped.||
1150|053|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1150|054|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1150|055|S|stool.||
1150|056|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1150|057|S|products because they may make symptoms worse.||
1150|058|S|   Use of this medication for prolonged or repeated periods may||
1150|059|S|result in oral thrush or a new yeast infection. Contact your||
1150|060|S|doctor if you notice white patches in your mouth, a change in||
1150|061|S|vaginal discharge, or other new symptoms.||
1150|062|S|   Get medical help right away if you have any very serious side||
1150|063|S|effects, including: seizure.||
1150|064|S|   A very serious allergic reaction to this drug is rare.||
1150|065|S|However, get medical help right away if you notice any symptoms||
1150|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1150|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1150|068|S|breathing.||
1150|069|S|   This is not a complete list of possible side effects. If you||
1150|070|S|notice other effects not listed above, contact your doctor or||
1150|071|S|pharmacist.||
1150|072|S|   In the US -||
1150|073|S|   Call your doctor for medical advice about side effects. You||
1150|074|S|may report side effects to FDA at 1-800-FDA-1088.||
1150|075|S|   In Canada - Call your doctor for medical advice about side||
1150|076|S|effects. You may report side effects to Health Canada at||
1150|077|S|1-866-234-2345.||
1150|078|B|||
1150|079|P|PRECAUTIONS:  Before using ceftobiprole, tell your doctor or||
1150|080|P|pharmacist if you are allergic to it; or to other cephalosporins;||
1150|081|P|or to penicillins; or if you have any other allergies. This||
1150|082|P|product may contain inactive ingredients, which can cause||
1150|083|P|allergic reactions or other problems. Talk to your pharmacist for||
1150|084|P|more details.||
1150|085|P|   Before using this medication, tell your doctor or pharmacist||
1150|086|P|your medical history, especially of: kidney disease, seizure||
1150|087|P|disorder.||
1150|088|P|   Ceftobiprole may cause live bacterial vaccines (such as||
1150|089|P|typhoid vaccine) to not work well. Tell your health care||
1150|090|P|professional that you are using ceftobiprole before having any||
1150|091|P|immunizations/vaccinations.||
1150|092|P|   Before having surgery, tell your doctor or dentist about all||
1150|093|P|the products you use (including prescription drugs,||
1150|094|P|nonprescription drugs, and herbal products).||
1150|095|P|   During pregnancy, this medication should be used only when||
1150|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
1150|097|P|   It is unknown if this drug passes into breast milk. Consult||
1150|098|P|your doctor before breastfeeding.||
1150|099|B|||
1150|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1150|101|I|medications work or increase your risk for serious side effects.||
1150|102|I|This document does not contain all possible drug interactions.||
1150|103|I|Keep a list of all the products you use (including||
1150|104|I|prescription/nonprescription drugs and herbal products) and share||
1150|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
1150|106|I|the dosage of any medicines without your doctor's approval.||
1150|107|I|   This medication may interfere with certain lab tests (such as||
1150|108|I|Coombs' test, urine glucose tests), possibly causing false test||
1150|109|I|results. Make sure lab personnel and all your doctors know you||
1150|110|I|use this drug.||
1150|111|B|||
1150|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1150|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1150|114|O|poison control center right away. US residents can call||
1150|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1150|116|B|||
1150|117|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1150|118|N|kidney function) may be done before you start using this||
1150|119|N|medication and while you are using it. Keep all medical and lab||
1150|120|N|appointments.||
1150|121|B|||
1150|122|D|MISSED DOSE:  It is important to get each dose of this medication||
1150|123|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1150|124|D|right away for a new dosing schedule. Do not double the dose to||
1150|125|D|catch up.||
1150|126|B|||
1150|127|R|STORAGE:  Consult the product instructions and your pharmacist||
1150|128|R|for storage details. Keep all medications away from children and||
1150|129|R|pets.||
1150|130|R|   Do not flush medications down the toilet or pour them into a||
1150|131|R|drain unless instructed to do so. Properly discard this product||
1150|132|R|when it is expired or no longer needed. Consult your pharmacist||
1150|133|R|or local waste disposal company.||
1150|134|B|||
1150|135|A|Information last revised April 2025.||
1150|136|A|Copyright(c) 2025 First Databank, Inc.||
1150|137|B|||
1151|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1151|002|Z|does NOT have all possible information about this product. This||
1151|003|Z|information does not assure that this product is safe, effective,||
1151|004|Z|or appropriate for you. This information is not individual||
1151|005|Z|medical advice and does not substitute for the advice of your||
1151|006|Z|health care professional. Always ask your health care||
1151|007|Z|professional for complete information about this product and your||
1151|008|Z|specific health needs.||
1151|009|B|||
1151|010|T|DICLOFENAC GEL - TOPICAL||
1151|011|F|(dye-KLOE-fen-ak)||
1151|012|B|||
1151|013|U|USES:  This medication is used to relieve joint and muscle pain||
1151|014|U|(such as a sprained ankle, muscle strain). Diclofenac is known as||
1151|015|U|a nonsteroidal anti-inflammatory drug (NSAID).||
1151|016|U|   Check the ingredients on the label even if you have used the||
1151|017|U|product before. The manufacturer may have changed the||
1151|018|U|ingredients. Also, products with similar names may contain||
1151|019|U|different ingredients meant for different purposes. Taking the||
1151|020|U|wrong product could harm you.||
1151|021|B|||
1151|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1151|023|H|from your pharmacist before you start using diclofenac. Read all||
1151|024|H|directions on the product package before using this medication.||
1151|025|H|If you have any questions, consult your pharmacist.||
1151|026|H|   This medication is for use on the skin only. Follow all||
1151|027|H|directions for the proper use of this medication. Wash and dry||
1151|028|H|your hands before applying the medication, then clean and dry the||
1151|029|H|affected area. Gently rub the medication into the affected joint||
1151|030|H|or muscle as directed by your doctor. Wash your hands after||
1151|031|H|using, unless you are using this medication to treat the hands.||
1151|032|H|   Follow the directions on the package label. To reduce your||
1151|033|H|risk of stomach bleeding and other side effects, use the lowest||
1151|034|H|effective dose for the shortest possible time. Do not increase||
1151|035|H|your dose or use it for more than 7 days unless otherwise||
1151|036|H|directed.||
1151|037|H|   Pain medications work best if they are used as the first signs||
1151|038|H|of pain occur. If you wait until the pain has worsened, the||
1151|039|H|medication may not work as well.||
1151|040|H|   Do not apply the medication on open skin wounds,||
1151|041|H|infected/scraped/burned skin, or irritated skin (such as eczema).||
1151|042|H|Do not wrap or bandage the treated area unless directed by the||
1151|043|H|doctor. Do not get the medication in the eyes, nose, mouth, or||
1151|044|H|vaginal/anal area. If you do get the medication in these areas,||
1151|045|H|flush with plenty of water. Contact your doctor right away if||
1151|046|H|irritation lasts.||
1151|047|H|   This medication may contain an ingredient that is flammable||
1151|048|H|when it gets on fabric (such as clothes, bedding). Avoid smoking||
1151|049|H|or being near open flames while using the medication.||
1151|050|H|   Tell your doctor if your pain does not get better within 7||
1151|051|H|days or if it gets worse.||
1151|052|B|||
1151|053|S|SIDE EFFECTS:  Rash, irritation, redness, or itching at the||
1151|054|S|application site may occur. If any of these effects last or get||
1151|055|S|worse, tell your doctor or pharmacist promptly.||
1151|056|S|   If your doctor has directed you to use this medication,||
1151|057|S|remember that your doctor has judged that the benefit to you is||
1151|058|S|greater than the risk of side effects. Many people using this||
1151|059|S|medication do not have serious side effects.||
1151|060|S|   This medication may raise your blood pressure. Check your||
1151|061|S|blood pressure regularly and tell your doctor if the results are||
1151|062|S|high.||
1151|063|S|   Tell your doctor right away if you have any serious side||
1151|064|S|effects, including: skin discoloration/peeling/blistering at the||
1151|065|S|application site, signs of kidney problems (such as change in the||
1151|066|S|amount of urine), symptoms of heart failure (such as swelling||
1151|067|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
1151|068|S|   Other medications similar to this medication may rarely cause||
1151|069|S|serious bleeding from the stomach or intestines. Rarely, related||
1151|070|S|drugs have caused blood clots to form, resulting in heart attacks||
1151|071|S|and strokes. If you notice any of the following rare but very||
1151|072|S|serious side effects, stop using this medication and get medical||
1151|073|S|help right away: stomach/abdominal pain that doesn't go away,||
1151|074|S|black/bloody stools, vomit that looks like coffee grounds,||
1151|075|S|chest/jaw/left arm pain, shortness of breath, unusual sweating,||
1151|076|S|sudden vision changes, weakness on one side of the body, trouble||
1151|077|S|speaking, confusion.||
1151|078|S|   This drug may rarely cause serious (possibly fatal) liver||
1151|079|S|disease. Get medical help right away if you have any symptoms of||
1151|080|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1151|081|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1151|082|S|urine.||
1151|083|S|   A very serious allergic reaction to this drug is rare.||
1151|084|S|However, get medical help right away if you notice any symptoms||
1151|085|S|of a serious allergic reaction, including: fever, swollen lymph||
1151|086|S|nodes, rash, itching/swelling (especially of the||
1151|087|S|face/tongue/throat), severe dizziness, trouble breathing.||
1151|088|S|   This is not a complete list of possible side effects. If you||
1151|089|S|notice other effects not listed above, contact your doctor or||
1151|090|S|pharmacist.||
1151|091|S|   In the US -||
1151|092|S|   Call your doctor for medical advice about side effects. You||
1151|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1151|094|S|www.fda.gov/medwatch.||
1151|095|S|   In Canada - Call your doctor for medical advice about side||
1151|096|S|effects. You may report side effects to Health Canada at||
1151|097|S|1-866-234-2345.||
1151|098|B|||
1151|099|P|PRECAUTIONS:  Before using diclofenac, tell your doctor or||
1151|100|P|pharmacist if you are allergic to it; or to aspirin or other||
1151|101|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
1151|102|P|any other allergies. This product may contain inactive||
1151|103|P|ingredients, which can cause allergic reactions or other||
1151|104|P|problems. Talk to your pharmacist for more details.||
1151|105|P|   If you have any of the following health problems, consult your||
1151|106|P|doctor or pharmacist before using this medication: asthma||
1151|107|P|(including a history of worsening breathing after taking aspirin||
1151|108|P|or other NSAIDs), liver disease, stomach/intestine problems (such||
1151|109|P|as bleeding, ulcers), heart disease (such as history of heart||
1151|110|P|attack), high blood pressure, stroke, recent heart bypass surgery||
1151|111|P|(CABG), swelling (edema, fluid retention), diabetes, blood||
1151|112|P|disorders (such as anemia), bleeding/clotting problems, growths||
1151|113|P|in the nose (nasal polyps).||
1151|114|P|   Kidney problems can sometimes occur with the use of NSAID||
1151|115|P|medications, including diclofenac. Problems are more likely to||
1151|116|P|occur if you are dehydrated, have heart failure or kidney||
1151|117|P|disease, are an older adult, or if you take certain medications||
1151|118|P|(see also Drug Interactions section). Drink plenty of fluids as||
1151|119|P|directed by your doctor to prevent dehydration and tell your||
1151|120|P|doctor right away if you have a change in the amount of urine.||
1151|121|P|   Before having surgery, tell your doctor or dentist about all||
1151|122|P|the products you use (including prescription drugs,||
1151|123|P|nonprescription drugs, and herbal products).||
1151|124|P|   This medicine may rarely cause stomach bleeding. Daily use of||
1151|125|P|alcohol and tobacco while using this medicine may increase your||
1151|126|P|risk for stomach bleeding. Limit alcohol and stop smoking. Ask||
1151|127|P|your doctor or pharmacist about how much alcohol you may safely||
1151|128|P|drink.||
1151|129|P|   This medication may make you more sensitive to the sun. Limit||
1151|130|P|your time in the sun. Avoid tanning booths and sunlamps. Wear||
1151|131|P|protective clothing when outdoors. Ask your doctor or pharmacist||
1151|132|P|whether you should use sunscreen along with this medication. Tell||
1151|133|P|your doctor right away if you get sunburned or have skin||
1151|134|P|blisters/redness.||
1151|135|P|   Older adults may be at greater risk for stomach/intestinal||
1151|136|P|bleeding, kidney problems, heart attack, and stroke while using||
1151|137|P|this drug.||
1151|138|P|   Before using this medication, women of childbearing age should||
1151|139|P|talk with their doctor(s) about the benefits and risks. Tell your||
1151|140|P|doctor if you are pregnant or if you plan to become pregnant.||
1151|141|P|This medication may harm an unborn baby and cause problems with||
1151|142|P|normal labor/delivery. It is not recommended for use in pregnancy||
1151|143|P|from 20 weeks until delivery. If your doctor decides that you||
1151|144|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1151|145|P|you should use the lowest effective dose for the shortest||
1151|146|P|possible time. You should not use this medication after 30 weeks||
1151|147|P|of pregnancy.||
1151|148|P|   It is unknown if this form of diclofenac passes into breast||
1151|149|P|milk. Consult your doctor before breastfeeding.||
1151|150|B|||
1151|151|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1151|152|I|medications work or increase your risk for serious side effects.||
1151|153|I|This document does not contain all possible drug interactions.||
1151|154|I|Keep a list of all the products you use (including||
1151|155|I|prescription/nonprescription drugs and herbal products) and share||
1151|156|I|it with your doctor and pharmacist. Do not start, stop, or change||
1151|157|I|the dosage of any medicines without your doctor's approval.||
1151|158|I|   Some products that may interact with this drug include:||
1151|159|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1151|160|I|angiotensin II receptor blockers (such as losartan, valsartan),||
1151|161|I|cidofovir, corticosteroids (such as dexamethasone, prednisone),||
1151|162|I|lithium, methotrexate, "water pills" (diuretics such as||
1151|163|I|furosemide).||
1151|164|I|   This medication may increase the risk of bleeding when used||
1151|165|I|with other drugs that also may cause bleeding. Examples include||
1151|166|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1151|167|I|dabigatran/enoxaparin/warfarin, among others.||
1151|168|I|   Check all prescription and nonprescription medicine labels||
1151|169|I|carefully since many medications contain pain relievers/fever||
1151|170|I|reducers (aspirin, NSAIDs such as ibuprofen, naproxen, or||
1151|171|I|ketorolac). These drugs are similar to diclofenac and may||
1151|172|I|increase your risk of side effects if taken together. However, if||
1151|173|I|your doctor has told you to take low-dose aspirin to prevent||
1151|174|I|heart attack or stroke (usually 81-162 milligrams a day), you||
1151|175|I|should keep taking the aspirin unless your doctor tells you not||
1151|176|I|to. Ask your doctor or pharmacist for more details.||
1151|177|B|||
1151|178|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1151|179|O|has overdosed and has serious symptoms such as passing out or||
1151|180|O|trouble breathing, call 911. Otherwise, call a poison control||
1151|181|O|center right away. US residents can call 1-800-222-1222. Canada||
1151|182|O|residents can call 1-844-764-7669. Symptoms of||
1151|183|O|overdose/swallowing may include: severe stomach pain, change in||
1151|184|O|the amount of urine, slow/shallow breathing.||
1151|185|B|||
1151|186|N|NOTES:  Do not share this medication with others.||
1151|187|N|   Lab and/or medical tests (such as blood pressure, complete||
1151|188|N|blood count, liver/kidney function) may be done while you are||
1151|189|N|using this medication. Keep all medical and lab appointments.||
1151|190|N|Consult your doctor for more details.||
1151|191|B|||
1151|192|D|MISSED DOSE:  Not applicable.||
1151|193|B|||
1151|194|R|STORAGE:  Store at room temperature. Keep all medications away||
1151|195|R|from children and pets.||
1151|196|R|   Do not flush medications down the toilet or pour them into a||
1151|197|R|drain unless instructed to do so. Properly discard this product||
1151|198|R|when it is expired or no longer needed. Consult your pharmacist||
1151|199|R|or local waste disposal company.||
1151|200|B|||
1151|201|A|Information last revised November 2025.||
1151|202|A|Copyright(c) 2025 First Databank, Inc.||
1151|203|B|||
1153|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1153|002|Z|does NOT have all possible information about this product. This||
1153|003|Z|information does not assure that this product is safe, effective,||
1153|004|Z|or appropriate for you. This information is not individual||
1153|005|Z|medical advice and does not substitute for the advice of your||
1153|006|Z|health care professional. Always ask your health care||
1153|007|Z|professional for complete information about this product and your||
1153|008|Z|specific health needs.||
1153|009|B|||
1153|010|T|RIVAROXABAN - ORAL||
1153|011|F|(RIV-a-ROX-a-ban)||
1153|012|B|||
1153|013|C|COMMON BRAND NAME(S): Xarelto||
1153|014|B|||
1153|015|W|WARNING:  Do not stop taking rivaroxaban unless directed by your||
1153|016|W|doctor. If you stop taking this medication early, you have a||
1153|017|W|higher risk of forming a serious blood clot (such as a stroke,||
1153|018|W|blood clot in the legs/lungs). Your doctor may direct you to take||
1153|019|W|a different "blood thinning" or antiplatelet medication to reduce||
1153|020|W|your risk. Get medical help right away if you have weakness on||
1153|021|W|one side of the body, trouble speaking, sudden vision changes,||
1153|022|W|confusion, chest pain, trouble breathing, or pain/warmth/swelling||
1153|023|W|in the legs.||
1153|024|W|   People taking this medication may bleed near the spinal cord||
1153|025|W|after certain spinal procedures. Bleeding in this area can cause||
1153|026|W|paralysis that lasts a long time or could become permanent.||
1153|027|W|Before any spinal procedure, ask your doctor about the benefits||
1153|028|W|and risks. The risk of bleeding may be higher if you have a||
1153|029|W|deformed spine, or have had spinal procedures/surgery before||
1153|030|W|(such as epidural catheter placement, difficult epidural/spinal||
1153|031|W|puncture), or are taking other drugs that can cause||
1153|032|W|bleeding/bruising (including antiplatelet drugs such as||
1153|033|W|clopidogrel, "blood thinners" such as warfarin/enoxaparin,||
1153|034|W|nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen).||
1153|035|W|Tell your doctor right away if you notice symptoms such as back||
1153|036|W|pain, leg numbness/tingling/weakness, loss of control of the||
1153|037|W|bowels or bladder (incontinence).||
1153|038|B|||
1153|039|U|USES:  Rivaroxaban is used to prevent blood clots from forming||
1153|040|U|due to a certain irregular heartbeat (atrial fibrillation) or||
1153|041|U|after hip or knee replacement surgery. It is also used to prevent||
1153|042|U|blood clots from forming in high-risk patients with limited||
1153|043|U|mobility during their hospital stay and after discharge. In||
1153|044|U|addition, rivaroxaban is used to treat blood clots (such as in||
1153|045|U|deep vein thrombosis-DVT or pulmonary embolus-PE) and to prevent||
1153|046|U|the blood clots from forming again. Rivaroxaban may be used in||
1153|047|U|children to prevent blood clots from forming after a certain||
1153|048|U|heart surgery (Fontan procedure).||
1153|049|U|   Rivaroxaban is an anticoagulant that works by blocking certain||
1153|050|U|clotting proteins in your blood.||
1153|051|B|||
1153|052|H|HOW TO USE:  Read the Medication Guide provided by your||
1153|053|H|pharmacist before you start taking rivaroxaban and each time you||
1153|054|H|get a refill. If you have any questions, ask your doctor or||
1153|055|H|pharmacist.||
1153|056|H|   Take this medication by mouth as directed by your doctor. If||
1153|057|H|you are taking this drug to prevent strokes and blood clots that||
1153|058|H|may form due to an irregular heartbeat, the dose is usually taken||
1153|059|H|once a day with the evening meal. If you are taking this||
1153|060|H|medication to prevent blood clots due to other conditions (such||
1153|061|H|as after knee or hip replacement surgery, during a hospital stay||
1153|062|H|and after discharge, after Fontan procedure), the dose is usually||
1153|063|H|taken once a day. For adults taking rivaroxaban to treat blood||
1153|064|H|clots, the dose is usually taken twice a day for the first 3||
1153|065|H|weeks, and then once a day. For children taking rivaroxaban to||
1153|066|H|treat blood clots, the dose is usually taken once a day. If you||
1153|067|H|are taking this medication to lower the risk of blood clots from||
1153|068|H|forming again, the dose is usually taken once a day. Carefully||
1153|069|H|follow your doctor's directions. Do not increase your dose, take||
1153|070|H|it more often, or stop taking it unless you are told to do so by||
1153|071|H|your doctor.||
1153|072|H|   The 10 milligrams tablet may be taken with or without food.||
1153|073|H|The 15 milligrams and 20 milligrams tablet should be taken with||
1153|074|H|food. If you have any questions about how to take rivaroxaban,||
1153|075|H|ask your doctor or pharmacist.||
1153|076|H|   If you are unable to swallow whole tablets, you may crush the||
1153|077|H|tablet and mix it with applesauce. Eat the entire mixture right||
1153|078|H|away. Do not prepare a supply for future use.||
1153|079|H|   If you are giving this medication through a tube into the||
1153|080|H|stomach (nasogastric or gastric tube), ask your health care||
1153|081|H|professional for detailed instructions on how to properly mix and||
1153|082|H|give it.||
1153|083|H|   The dosage and length of treatment is based on your medical||
1153|084|H|condition and response to treatment. Children's dosage is also||
1153|085|H|based on weight.||
1153|086|H|   Use this medication regularly to get the most benefit from it.||
1153|087|H|To help you remember, take it at the same time(s) each day.||
1153|088|B|||
1153|089|S|SIDE EFFECTS:  See also Warning section.||
1153|090|S|   Easy bruising or minor bleeding (such as nosebleed, bleeding||
1153|091|S|from cuts) may occur. If any of these effects last or get worse,||
1153|092|S|tell your doctor or pharmacist promptly.||
1153|093|S|   Remember that this medication has been prescribed because your||
1153|094|S|doctor has judged that the benefit to you is greater than the||
1153|095|S|risk of side effects. Many people using this medication do not||
1153|096|S|have serious side effects.||
1153|097|S|   This medication can cause serious bleeding if it affects your||
1153|098|S|blood clotting proteins too much. Tell your doctor right away if||
1153|099|S|you have any signs of serious bleeding, including: nosebleeds||
1153|100|S|that happen often or don't stop, unusual tiredness/weakness,||
1153|101|S|unusual pain/swelling/discomfort, unusual bruising, prolonged||
1153|102|S|bleeding from cuts or gums, unusually heavy/prolonged menstrual||
1153|103|S|flow, pink/dark urine, coughing up blood, vomit that is bloody or||
1153|104|S|looks like coffee grounds, severe headache, dizziness/fainting,||
1153|105|S|bloody/black/tarry stools, difficulty swallowing.||
1153|106|S|   Get medical help right away if you have any signs of very||
1153|107|S|serious bleeding, including: vision changes, confusion, trouble||
1153|108|S|speaking, weakness on one side of the body, injury to the spleen||
1153|109|S|(such as stomach/abdominal pain, shoulder pain).||
1153|110|S|   A very serious allergic reaction to this drug is rare.||
1153|111|S|However, get medical help right away if you notice any symptoms||
1153|112|S|of a serious allergic reaction, including: rash, itching/swelling||
1153|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1153|114|S|breathing.||
1153|115|S|   This is not a complete list of possible side effects. If you||
1153|116|S|notice other effects not listed above, contact your doctor or||
1153|117|S|pharmacist.||
1153|118|S|   In the US -||
1153|119|S|   Call your doctor for medical advice about side effects. You||
1153|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1153|121|S|www.fda.gov/medwatch.||
1153|122|S|   In Canada - Call your doctor for medical advice about side||
1153|123|S|effects. You may report side effects to Health Canada at||
1153|124|S|1-866-234-2345.||
1153|125|B|||
1153|126|P|PRECAUTIONS:  Before taking rivaroxaban, tell your doctor or||
1153|127|P|pharmacist if you are allergic to it; or if you have any other||
1153|128|P|allergies. This product may contain inactive ingredients, which||
1153|129|P|can cause allergic reactions or other problems. Talk to your||
1153|130|P|pharmacist for more details.||
1153|131|P|   Before using this medication, tell your doctor or pharmacist||
1153|132|P|your medical history, especially of: cancer, liver disease,||
1153|133|P|kidney disease, bleeding problems (such as bleeding of the||
1153|134|P|stomach/intestines, bleeding in the brain), stroke, artificial||
1153|135|P|heart valves, recent major injury/surgery, blood disorders (such||
1153|136|P|as anemia, hemophilia, thrombocytopenia), frequent||
1153|137|P|falls/injuries, certain eye problem (retinopathy), a certain||
1153|138|P|clotting disorder (antiphospholipid syndrome), certain hereditary||
1153|139|P|enzyme problems (such as galactose intolerance, Lapp lactase||
1153|140|P|deficiency, glucose-galactose malabsorption).||
1153|141|P|   Before having surgery or any medical/dental procedures||
1153|142|P|(especially spinal puncture or spinal/epidural anesthesia), tell||
1153|143|P|your doctor or dentist that you are taking this medication and||
1153|144|P|about all the products you use (including prescription drugs,||
1153|145|P|nonprescription drugs, and herbal products). Your doctor or||
1153|146|P|dentist may tell you to stop taking rivaroxaban before your||
1153|147|P|surgery. Ask for specific instructions about stopping or starting||
1153|148|P|this medication.||
1153|149|P|   This medication may cause stomach bleeding. Daily use of||
1153|150|P|alcohol while using this medicine will increase your risk for||
1153|151|P|stomach bleeding. Limit alcoholic beverages. Ask your doctor or||
1153|152|P|pharmacist about how much alcohol you may safely drink.||
1153|153|P|   This medication can cause heavy bleeding. To lower the chance||
1153|154|P|of getting cut, bruised, or injured, use caution with sharp||
1153|155|P|objects like razors and nail cutters, and avoid activities such||
1153|156|P|as contact sports. Use an electric razor when shaving and a soft||
1153|157|P|toothbrush when brushing your teeth. If you fall or injure||
1153|158|P|yourself, especially if you hit your head, call your doctor right||
1153|159|P|away. Your doctor may need to check you.||
1153|160|P|   Older adults may be more sensitive to the side effects of this||
1153|161|P|drug, especially bleeding.||
1153|162|P|   During pregnancy, this medication should be used only when||
1153|163|P|clearly needed. Discuss the risks and benefits with your doctor.||
1153|164|P|   This medication may pass into breast milk. Consult your doctor||
1153|165|P|before breastfeeding.||
1153|166|B|||
1153|167|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1153|168|I|medications work or increase your risk for serious side effects.||
1153|169|I|This document does not contain all possible drug interactions.||
1153|170|I|Keep a list of all the products you use (including||
1153|171|I|prescription/nonprescription drugs and herbal products) and share||
1153|172|I|it with your doctor and pharmacist. Do not start, stop, or change||
1153|173|I|the dosage of any medicines without your doctor's approval.||
1153|174|I|   Some products that may interact with this drug include:||
1153|175|I|mifepristone, other drugs that can cause bleeding/bruising||
1153|176|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
1153|177|I|ibuprofen/naproxen, "blood thinners" such as||
1153|178|I|warfarin/enoxaparin), certain antidepressants (including SSRIs||
1153|179|I|such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine).||
1153|180|I|   Other medications can affect the removal of rivaroxaban from||
1153|181|I|your body, which may affect how rivaroxaban works. Examples||
1153|182|I|include cobicistat, dronedarone, ritonavir, certain azole||
1153|183|I|antifungals (itraconazole, ketoconazole, posaconazole), HIV||
1153|184|I|protease inhibitors (such as lopinavir), rifamycins (such as||
1153|185|I|rifampin), St. John's wort, drugs used to treat seizures (such as||
1153|186|I|carbamazepine, phenytoin, phenobarbital), among others.||
1153|187|I|   Aspirin can increase the risk of bleeding when used with this||
1153|188|I|medication. However, if your doctor has told you to take low-dose||
1153|189|I|aspirin to prevent heart attack or stroke (usually 81-162||
1153|190|I|milligrams a day), you should keep taking the aspirin unless your||
1153|191|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1153|192|I|details.||
1153|193|B|||
1153|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1153|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1153|196|O|poison control center right away. US residents can call||
1153|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1153|198|O|Symptoms of overdose may include: bloody/black/tarry stools,||
1153|199|O|pink/dark urine, unusual/prolonged bleeding.||
1153|200|B|||
1153|201|N|NOTES:  Do not share this medication with others.||
1153|202|N|   Lab and/or medical tests (such as hematocrit/hemoglobin, red||
1153|203|N|blood cell count) may be done while you are taking this||
1153|204|N|medication. Keep all medical and lab appointments. Consult your||
1153|205|N|doctor for more details.||
1153|206|B|||
1153|207|D|MISSED DOSE:  If you are taking this medication once a day and||
1153|208|D|miss a dose, take it as soon as you remember. If it is near the||
1153|209|D|time of the next dose, skip the missed dose. Take your next dose||
1153|210|D|at the regular time. Do not double the dose to catch up.||
1153|211|D|   If you are taking this medication twice a day and miss a dose,||
1153|212|D|take it as soon as you remember. If you missed the morning dose||
1153|213|D|and it is near the time of the evening dose, you may take both||
1153|214|D|doses together. Then take your next dose at the regular time.||
1153|215|B|||
1153|216|R|STORAGE:  Store at room temperature away from light and moisture.||
1153|217|R|Do not store in the bathroom. Keep all medications away from||
1153|218|R|children and pets.||
1153|219|R|   Use/discard the crushed tablet mixture within 4 hours. (See||
1153|220|R|also How to Use section.)||
1153|221|R|   Do not flush medications down the toilet or pour them into a||
1153|222|R|drain unless instructed to do so. Properly discard this product||
1153|223|R|when it is expired or no longer needed. Consult your pharmacist||
1153|224|R|or local waste disposal company.||
1153|225|B|||
1153|226|M|MEDICAL ALERT:  Your condition can cause complications in a||
1153|227|M|medical emergency. For information about enrolling in MedicAlert,||
1153|228|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1153|229|B|||
1153|230|A|Information last revised June 2025.||
1153|231|A|Copyright(c) 2025 First Databank, Inc.||
1153|232|B|||
1155|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1155|002|Z|does NOT have all possible information about this product. This||
1155|003|Z|information does not assure that this product is safe, effective,||
1155|004|Z|or appropriate for you. This information is not individual||
1155|005|Z|medical advice and does not substitute for the advice of your||
1155|006|Z|health care professional. Always ask your health care||
1155|007|Z|professional for complete information about this product and your||
1155|008|Z|specific health needs.||
1155|009|B|||
1155|010|T|TETRABENAZINE - ORAL||
1155|011|F|(TE-tra-BEN-a-zeen)||
1155|012|B|||
1155|013|C|COMMON BRAND NAME(S): Xenazine||
1155|014|B|||
1155|015|W|WARNING:  Tetrabenazine can sometimes increase the risk of||
1155|016|W|depression and suicidal thoughts/attempts. People with||
1155|017|W|Huntington's disease are more likely to have depression and||
1155|018|W|suicidal thoughts/attempts. Discuss the risks and benefits of||
1155|019|W|this medication with your doctor. People who are not being||
1155|020|W|treated for their depression and suicidal thoughts/attempts, or||
1155|021|W|people who have ongoing symptoms of these conditions (even with||
1155|022|W|medication/treatment) must not use tetrabenazine. Tell your||
1155|023|W|doctor right away if you or your family/caregivers notice that||
1155|024|W|you have new/worsening symptoms of depression, sadness, loss of||
1155|025|W|interest in activities you used to enjoy, suicidal||
1155|026|W|thoughts/attempts, or other mental/mood/behavior changes (such as||
1155|027|W|new/worsening anxiety, panic attacks, trouble sleeping,||
1155|028|W|irritability, hostile/angry feelings, strong/abnormal urges,||
1155|029|W|severe restlessness, very rapid speech).||
1155|030|B|||
1155|031|U|USES:  Tetrabenazine is used to decrease the uncontrollable||
1155|032|U|movements (chorea) caused by Huntington's disease. However, it is||
1155|033|U|not a cure for the disease. Reducing the chorea will help you||
1155|034|U|take part in more of your normal daily activities. This||
1155|035|U|medication is thought to work by decreasing the amount of certain||
1155|036|U|natural substances in the brain (monoamines such as dopamine,||
1155|037|U|serotonin, and norepinephrine), which are involved with nerve and||
1155|038|U|muscle function. Tetrabenazine belongs to a class of drugs called||
1155|039|U|monoamine depletors.||
1155|040|B|||
1155|041|H|HOW TO USE:  Read the Medication Guide provided by your||
1155|042|H|pharmacist before you start using tetrabenazine and each time you||
1155|043|H|get a refill. If you have any questions, consult your doctor or||
1155|044|H|pharmacist.||
1155|045|H|   Take this medication by mouth with or without food as directed||
1155|046|H|by your doctor, usually once a day in the morning when you first||
1155|047|H|start treatment. Your doctor may gradually increase your dose to||
1155|048|H|2 or 3 times a day over several weeks. A slow increase in your||
1155|049|H|dose will help your doctor find the best dose for you while||
1155|050|H|keeping side effects as low as possible.||
1155|051|H|   The dosage is based on your medical condition, response to||
1155|052|H|treatment, and other medications you may be taking. Be sure to||
1155|053|H|tell your doctor and pharmacist about all the products you use||
1155|054|H|(including prescription drugs, nonprescription drugs, and herbal||
1155|055|H|products).||
1155|056|H|   Take this medication regularly to get the most benefit from||
1155|057|H|it. To help you remember, take it at the same time(s) each day.||
1155|058|H|   If you stop taking this drug for several days, then start||
1155|059|H|taking it again, you may need to slowly increase your dose until||
1155|060|H|you reach the regular dose you had been taking. Follow your||
1155|061|H|doctor's directions on how to restart treatment.||
1155|062|H|   Tell your doctor if your uncontrolled movements do not get||
1155|063|H|better or if they get worse.||
1155|064|B|||
1155|065|S|SIDE EFFECTS:  See also Warning section.||
1155|066|S|   Drowsiness, trouble sleeping, tiredness, dizziness, nausea,||
1155|067|S|and vomiting may occur. If any of these effects last or get||
1155|068|S|worse, tell your doctor or pharmacist promptly. Your doctor may||
1155|069|S|need to adjust your dose to reduce these side effects.||
1155|070|S|   To reduce the risk of dizziness and lightheadedness, get up||
1155|071|S|slowly when rising from a sitting or lying position.||
1155|072|S|   Remember that this medication has been prescribed because your||
1155|073|S|doctor has judged that the benefit to you is greater than the||
1155|074|S|risk of side effects. Many people using this medication do not||
1155|075|S|have serious side effects.||
1155|076|S|   Sometimes tetrabenazine can cause side effects that are||
1155|077|S|similar to the symptoms of worsening Huntington's disease. Your||
1155|078|S|doctor may need to adjust your dose to see if these side effects||
1155|079|S|are due to the drug or to the disease. Tell your doctor right||
1155|080|S|away if any of these serious side effects occur: mental/mood||
1155|081|S|changes (such as new/worsening depression, suicidal||
1155|082|S|thoughts/attempts, problems with thinking), Parkinson's disease||
1155|083|S|symptoms (such as shaking/tremors, slowed movement, loss of||
1155|084|S|balance), trouble swallowing, restlessness.||
1155|085|S|   Tell your doctor right away if you have any serious side||
1155|086|S|effects, including: signs of increased prolactin hormone (such as||
1155|087|S|enlarged breasts, abnormal breast milk production, decreased||
1155|088|S|sexual ability, a change in menstrual cycle).||
1155|089|S|   This medication may rarely cause a very serious condition||
1155|090|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1155|091|S|right away if you have any of the following symptoms: fever,||
1155|092|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1155|093|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1155|094|S|signs of kidney problems (such as change in the amount of urine).||
1155|095|S|   A very serious allergic reaction to this drug is rare.||
1155|096|S|However, get medical help right away if you notice any symptoms||
1155|097|S|of a serious allergic reaction, including: rash, itching/swelling||
1155|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1155|099|S|breathing.||
1155|100|S|   This is not a complete list of possible side effects. If you||
1155|101|S|notice other effects not listed above, contact your doctor or||
1155|102|S|pharmacist.||
1155|103|S|   In the US -||
1155|104|S|   Call your doctor for medical advice about side effects. You||
1155|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1155|106|S|www.fda.gov/medwatch.||
1155|107|S|   In Canada - Call your doctor for medical advice about side||
1155|108|S|effects. You may report side effects to Health Canada at||
1155|109|S|1-866-234-2345.||
1155|110|B|||
1155|111|P|PRECAUTIONS:  See also Warning section.||
1155|112|P|   Before taking tetrabenazine, tell your doctor or pharmacist if||
1155|113|P|you are allergic to it; or to deutetrabenazine; or if you have||
1155|114|P|any other allergies. This product may contain inactive||
1155|115|P|ingredients, which can cause allergic reactions or other||
1155|116|P|problems. Talk to your pharmacist for more details.||
1155|117|P|   Before using this medication, tell your doctor or pharmacist||
1155|118|P|your medical history, especially of: breast cancer, liver||
1155|119|P|problems, certain heart problems (fast/slow/irregular heartbeat,||
1155|120|P|QT prolongation in the EKG).||
1155|121|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1155|122|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1155|123|P|machinery, or do anything that needs alertness until you can do||
1155|124|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1155|125|P|are using marijuana (cannabis).||
1155|126|P|   Before having surgery, tell your doctor or dentist about all||
1155|127|P|the products you use (including prescription drugs,||
1155|128|P|nonprescription drugs, and herbal products).||
1155|129|P|   During pregnancy, this medication should be used only when||
1155|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
1155|131|P|   It is unknown if this drug passes into breast milk. Consult||
1155|132|P|your doctor before breastfeeding.||
1155|133|B|||
1155|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1155|135|I|medications work or increase your risk for serious side effects.||
1155|136|I|This document does not contain all possible drug interactions.||
1155|137|I|Keep a list of all the products you use (including||
1155|138|I|prescription/nonprescription drugs and herbal products) and share||
1155|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
1155|140|I|the dosage of any medicines without your doctor's approval.||
1155|141|I|   Some products that may interact with this drug are:||
1155|142|I|valbenazine.||
1155|143|I|   Taking MAO inhibitors with this medication may cause a serious||
1155|144|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
1155|145|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1155|146|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1155|147|I|selegiline, tranylcypromine) during treatment with this||
1155|148|I|medication. Most MAO inhibitors should also not be taken for two||
1155|149|I|weeks before and after treatment with this medication. Ask your||
1155|150|I|doctor when to start or stop taking this medication.||
1155|151|I|   Tetrabenazine is very similar to deutetrabenazine. Do not use||
1155|152|I|medications containing deutetrabenazine while using||
1155|153|I|tetrabenazine.||
1155|154|B|||
1155|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1155|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1155|157|O|poison control center right away. US residents can call||
1155|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1155|159|O|Symptoms of overdose may include: muscle stiffness/pain, fixed||
1155|160|O|upward position of the eyeballs, sweating, dizziness, severe||
1155|161|O|drowsiness.||
1155|162|B|||
1155|163|N|NOTES:  Do not share this medication with others.||
1155|164|N|   Lab and/or medical tests may be done while you are taking this||
1155|165|N|medication. Keep all medical and lab appointments. Consult your||
1155|166|N|doctor for more details.||
1155|167|B|||
1155|168|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1155|169|D|remember. If it is near the time of the next dose, skip the||
1155|170|D|missed dose. Take your next dose at the regular time. Do not||
1155|171|D|double the dose to catch up.||
1155|172|B|||
1155|173|R|STORAGE:  Store at room temperature away from light and moisture.||
1155|174|R|Do not store in the bathroom. Keep all medications away from||
1155|175|R|children and pets.||
1155|176|R|   Do not flush medications down the toilet or pour them into a||
1155|177|R|drain unless instructed to do so. Properly discard this product||
1155|178|R|when it is expired or no longer needed. Consult your pharmacist||
1155|179|R|or local waste disposal company.||
1155|180|B|||
1155|181|A|Information last revised November 2024.||
1155|182|A|Copyright(c) 2025 First Databank, Inc.||
1155|183|B|||
1158|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1158|002|Z|does NOT have all possible information about this product. This||
1158|003|Z|information does not assure that this product is safe, effective,||
1158|004|Z|or appropriate for you. This information is not individual||
1158|005|Z|medical advice and does not substitute for the advice of your||
1158|006|Z|health care professional. Always ask your health care||
1158|007|Z|professional for complete information about this product and your||
1158|008|Z|specific health needs.||
1158|009|B|||
1158|010|T|ELTROMBOPAG - ORAL||
1158|011|F|(el-TROM-boe-pag)||
1158|012|B|||
1158|013|C|COMMON BRAND NAME(S): Alvaiz, Promacta||
1158|014|B|||
1158|015|W|WARNING:  Eltrombopag may rarely cause severe (possibly fatal)||
1158|016|W|liver problems. People with a certain liver problem (chronic||
1158|017|W|hepatitis C) who are taking this medication with ribavirin and||
1158|018|W|interferon may sometimes experience worsening of their liver||
1158|019|W|problem. To help decrease the risk of liver problems, your doctor||
1158|020|W|will order lab tests (liver function tests) before you start||
1158|021|W|eltrombopag and while you are taking it. Keep all medical and lab||
1158|022|W|appointments. Get medical help right away if you develop new or||
1158|023|W|worsening symptoms of liver problems (such as nausea/vomiting||
1158|024|W|that doesn't stop, loss of appetite, stomach/abdominal pain,||
1158|025|W|stomach/abdominal swelling, dark urine, yellowing eyes/skin,||
1158|026|W|mental/mood changes). Talk with your doctor about the risks and||
1158|027|W|benefits of this medication.||
1158|028|B|||
1158|029|U|USES:  This medication is used to treat low platelet levels in||
1158|030|U|people who have a certain blood disorder called chronic immune||
1158|031|U|(idiopathic) thrombocytopenia purpura (ITP) or who have chronic||
1158|032|U|hepatitis C. It may also be used to treat people with a certain||
1158|033|U|blood disorder (aplastic anemia). Platelets are a type of blood||
1158|034|U|cell needed to form blood clots and prevent bleeding. Eltrombopag||
1158|035|U|decreases your risk of bleeding by increasing the number of||
1158|036|U|platelets. Eltrombopag acts like a certain natural substance||
1158|037|U|(thrombopoietin) that causes the body to produce platelets.||
1158|038|B|||
1158|039|H|HOW TO USE:  Read the Medication Guide provided by your||
1158|040|H|pharmacist before you start using eltrombopag and each time you||
1158|041|H|get a refill. If you have any questions, consult your doctor or||
1158|042|H|pharmacist.||
1158|043|H|   There are different brands and forms of eltrombopag available,||
1158|044|H|and the doses may be different. Do not change brands or forms||
1158|045|H|without first consulting your doctor or pharmacist.||
1158|046|H|   Take this medication by mouth as directed by your doctor,||
1158|047|H|usually once daily. Take it without a meal or with a meal low in||
1158|048|H|calcium (50 milligrams or less). Ask your doctor or pharmacist||
1158|049|H|for details.||
1158|050|H|   Take this medication at least 2 hours before or 4 hours after||
1158|051|H|taking any products that contain magnesium, aluminum, or||
1158|052|H|calcium-rich foods (containing more than 50 milligrams calcium).||
1158|053|H|Some examples include antacids, dairy products (such as milk,||
1158|054|H|yogurt), juice with added calcium, vitamins/minerals, quinapril,||
1158|055|H|and sucralfate. Follow the same instructions with bismuth||
1158|056|H|subsalicylate, iron, selenium, and zinc. These products may keep||
1158|057|H|eltrombopag from working well.||
1158|058|H|   The manufacturer directs not to split, chew, or crush the||
1158|059|H|tablet before taking it, and not to mix it with food or liquid.||
1158|060|H|However, many similar drugs (immediate-release tablets) can be||
1158|061|H|split, chewed, or crushed. Follow your doctor's directions on how||
1158|062|H|to take this medication. The manufacturer also states that the||
1158|063|H|powder from the tablet may stain surfaces.||
1158|064|H|   If you are using the suspension powder, read the||
1158|065|H|manufacturer's Instructions for Use before you start using this||
1158|066|H|medication. Ask your health care provider if you have any||
1158|067|H|questions. Carefully follow the directions to mix and use each||
1158|068|H|dose. Use the provided mixing bottle to mix each dose with cool||
1158|069|H|or cold water. Gently and slowly shake the mixing bottle for at||
1158|070|H|least 20 seconds to mix the water with the powder. After mixing,||
1158|071|H|give this medication right away. Use the provided special||
1158|072|H|measuring device (oral syringe) to prepare and give each dose. Do||
1158|073|H|not use a household spoon because you may not get the correct||
1158|074|H|dose. Do not re-use the oral syringe. Use a new oral syringe for||
1158|075|H|each dose. If not used right away, the mixed medication may be||
1158|076|H|stored at room temperature for up to 30 minutes. After 30||
1158|077|H|minutes, throw away any unused mixture, or any mixture left in||
1158|078|H|the bottle. Clean the mixing supplies as directed.||
1158|079|H|   Take this medication regularly to get the most benefit from||
1158|080|H|it. To help you remember, take it at the same time each day. The||
1158|081|H|dosage is based on your medical condition, response to treatment,||
1158|082|H|age, and lab tests. Your doctor will order blood tests (platelet||
1158|083|H|counts) to find the right dose for you. Keep all medical/lab||
1158|084|H|appointments. Follow your doctor's directions carefully. If you||
1158|085|H|are of East-Asian/Southeast-Asian descent or if you have liver||
1158|086|H|problems, your doctor may direct you to start with a lower dose||
1158|087|H|because you may be more sensitive to its effects.||
1158|088|H|   Your risk of bleeding may increase when you stop using||
1158|089|H|eltrombopag. After your last dose, your doctor should order a||
1158|090|H|blood test once a week for at least 4 weeks to check your||
1158|091|H|platelet count. Tell your doctor right away if you develop any||
1158|092|H|bleeding/bruising.||
1158|093|H|   Ask your doctor if you should keep taking your other||
1158|094|H|medications for ITP (such as corticosteroids, azathioprine,||
1158|095|H|danazol) while you are using eltrombopag.||
1158|096|H|   Tell your doctor if your condition (bleeding/bruising) does||
1158|097|H|not get better or if it gets worse.||
1158|098|B|||
1158|099|S|SIDE EFFECTS:  See also Warning section.||
1158|100|S|   Nausea, diarrhea, headache, muscle pain, and tingling/numbness||
1158|101|S|may occur. If any of these effects last or get worse, tell your||
1158|102|S|doctor or pharmacist promptly.||
1158|103|S|   Remember that this medication has been prescribed because your||
1158|104|S|doctor has judged that the benefit to you is greater than the||
1158|105|S|risk of side effects. Many people using this medication do not||
1158|106|S|have serious side effects.||
1158|107|S|   Tell your doctor right away if you have any serious side||
1158|108|S|effects, including: vision changes.||
1158|109|S|   This medication may rarely cause serious problems from blood||
1158|110|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1158|111|S|legs) especially if your platelet counts are too high. Keep all||
1158|112|S|medical/lab test appointments. Get medical help right away if you||
1158|113|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1158|114|S|pain, sudden dizziness/fainting, pain/swelling/warmth in the||
1158|115|S|groin/calf, trouble speaking, weakness on one side of the body,||
1158|116|S|unusual sweating, confusion, sudden/severe headaches, sudden||
1158|117|S|vision changes.||
1158|118|S|   Eltrombopag can commonly cause a rash that is usually not||
1158|119|S|serious. However, you may not be able to tell it apart from a||
1158|120|S|rare rash that could be a sign of a severe reaction. Get medical||
1158|121|S|help right away if you develop any rash.||
1158|122|S|   A very serious allergic reaction to this drug is rare.||
1158|123|S|However, get medical help right away if you notice any symptoms||
1158|124|S|of a serious allergic reaction, including: rash, itching/swelling||
1158|125|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1158|126|S|breathing.||
1158|127|S|   This is not a complete list of possible side effects. If you||
1158|128|S|notice other effects not listed above, contact your doctor or||
1158|129|S|pharmacist.||
1158|130|S|   In the US -||
1158|131|S|   Call your doctor for medical advice about side effects. You||
1158|132|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1158|133|S|www.fda.gov/medwatch.||
1158|134|S|   In Canada - Call your doctor for medical advice about side||
1158|135|S|effects. You may report side effects to Health Canada at||
1158|136|S|1-866-234-2345.||
1158|137|B|||
1158|138|P|PRECAUTIONS:  Before using eltrombopag, tell your doctor or||
1158|139|P|pharmacist if you are allergic to it; or if you have any other||
1158|140|P|allergies. This product may contain inactive ingredients, which||
1158|141|P|can cause allergic reactions or other problems. Talk to your||
1158|142|P|pharmacist for more details.||
1158|143|P|   Before using this medication, tell your doctor or pharmacist||
1158|144|P|your medical history, especially of: blood clots/clotting||
1158|145|P|problems (such as Factor V Leiden), other blood disorders (such||
1158|146|P|as blood cancer, myelodysplastic syndrome), certain eye problem||
1158|147|P|(cataracts), liver disease.||
1158|148|P|   Before having surgery, tell your doctor or dentist about all||
1158|149|P|the products you use (including prescription drugs,||
1158|150|P|nonprescription drugs, and herbal products).||
1158|151|P|   Although this medication increases platelets and decreases the||
1158|152|P|risk of bleeding, continue to avoid activities that can increase||
1158|153|P|your risk of bleeding (such as contact sports, using sharp||
1158|154|P|objects like razors and nail cutters).||
1158|155|P|   Tell your doctor if you are pregnant or plan to become||
1158|156|P|pregnant. You should not become pregnant while using eltrombopag.||
1158|157|P|Eltrombopag may harm an unborn baby. Ask about reliable forms of||
1158|158|P|birth control while using this medication and for 7 days after||
1158|159|P|the last dose. If you become pregnant, talk to your doctor right||
1158|160|P|away about the risks and benefits of this medication.||
1158|161|P|   It is unknown if this medication passes into breast milk.||
1158|162|P|Because of the possible risk to the infant, breastfeeding is not||
1158|163|P|recommended while using this medication. Consult your doctor||
1158|164|P|before breastfeeding.||
1158|165|B|||
1158|166|I|DRUG INTERACTIONS:  See also How to Use.||
1158|167|I|   Drug interactions may change how your medications work or||
1158|168|I|increase your risk for serious side effects. This document does||
1158|169|I|not contain all possible drug interactions. Keep a list of all||
1158|170|I|the products you use (including prescription/nonprescription||
1158|171|I|drugs and herbal products) and share it with your doctor and||
1158|172|I|pharmacist. Do not start, stop, or change the dosage of any||
1158|173|I|medicines without your doctor's approval.||
1158|174|I|   This medication may interfere with certain lab tests||
1158|175|I|(creatinine and bilirubin), possibly causing false test results.||
1158|176|I|Make sure lab personnel and all your doctors know you use this||
1158|177|I|drug.||
1158|178|B|||
1158|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1158|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1158|181|O|poison control center right away. US residents can call||
1158|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1158|183|B|||
1158|184|N|NOTES:  Do not share this medication with others.||
1158|185|N|   Lab and/or medical tests (such as complete blood count, eye||
1158|186|N|exams) should be done before you start taking this medication and||
1158|187|N|while you are taking it. Keep all medical and lab appointments.||
1158|188|N|See also Warnings section. Consult your doctor for more details.||
1158|189|B|||
1158|190|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1158|191|D|next dose at the regular time. Do not double the dose to catch||
1158|192|D|up. Do not take more than 1 dose in 24 hours.||
1158|193|B|||
1158|194|R|STORAGE:  Different brands and forms of this medication have||
1158|195|R|different storage needs. Check the product package for storage||
1158|196|R|instructions or ask your pharmacist. Keep all medications away||
1158|197|R|from children and pets.||
1158|198|R|   Do not flush medications down the toilet or pour them into a||
1158|199|R|drain unless instructed to do so. Properly discard this product||
1158|200|R|when it is expired or no longer needed. Consult your pharmacist||
1158|201|R|or local waste disposal company.||
1158|202|B|||
1158|203|M|MEDICAL ALERT:  Your condition can cause complications in a||
1158|204|M|medical emergency. For information about enrolling in MedicAlert,||
1158|205|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1158|206|B|||
1158|207|A|Information last revised September 2025.||
1158|208|A|Copyright(c) 2025 First Databank, Inc.||
1158|209|B|||
1159|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1159|002|Z|does NOT have all possible information about this product. This||
1159|003|Z|information does not assure that this product is safe, effective,||
1159|004|Z|or appropriate for you. This information is not individual||
1159|005|Z|medical advice and does not substitute for the advice of your||
1159|006|Z|health care professional. Always ask your health care||
1159|007|Z|professional for complete information about this product and your||
1159|008|Z|specific health needs.||
1159|009|B|||
1159|010|T|AMOXICILLIN EXTENDED-RELEASE TABLET- ORAL||
1159|011|F|(a-MOX-i-SIL-in)||
1159|012|B|||
1159|013|C|COMMON BRAND NAME(S): Moxatag||
1159|014|B|||
1159|015|U|USES:  Amoxicillin is used to treat a wide variety of bacterial||
1159|016|U|infections. This medication is a penicillin-type antibiotic. It||
1159|017|U|works by stopping the growth of bacteria.||
1159|018|U|   This antibiotic treats only bacterial infections. It will not||
1159|019|U|work for viral infections (such as common cold, flu). Using any||
1159|020|U|antibiotic when it is not needed can cause it to not work for||
1159|021|U|future infections.||
1159|022|B|||
1159|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
1159|024|H|doctor, within 1 hour of finishing a meal, usually once a day.||
1159|025|H|The dosage is based on your medical condition and response to||
1159|026|H|treatment.||
1159|027|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1159|028|H|Doing so can release all of the drug at once, increasing the risk||
1159|029|H|of side effects.||
1159|030|H|   Drink plenty of fluids while using this medication unless your||
1159|031|H|doctor tells you otherwise.||
1159|032|H|   For the best effect, take this antibiotic at evenly spaced||
1159|033|H|times. To help you remember, take this medication at the same||
1159|034|H|time(s) every day.||
1159|035|H|   Continue to take this medication until the full prescribed||
1159|036|H|amount is finished, even if symptoms disappear after a few days.||
1159|037|H|Stopping the medication too early may result in a return of the||
1159|038|H|infection.||
1159|039|H|   Tell your doctor if your condition lasts or gets worse.||
1159|040|B|||
1159|041|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. If any of||
1159|042|S|these effects last or get worse, tell your doctor or pharmacist||
1159|043|S|promptly.||
1159|044|S|   Remember that this medication has been prescribed because your||
1159|045|S|doctor has judged that the benefit to you is greater than the||
1159|046|S|risk of side effects. Many people using this medication do not||
1159|047|S|have serious side effects.||
1159|048|S|   Use of this medication for prolonged or repeated periods may||
1159|049|S|result in oral thrush or a new vaginal yeast infection (oral or||
1159|050|S|vaginal fungal infection). Contact your doctor if you notice||
1159|051|S|white patches in your mouth, a change in vaginal discharge or||
1159|052|S|other new symptoms.||
1159|053|S|   Tell your doctor right away if you have any serious side||
1159|054|S|effects, including: signs of liver disease (such as||
1159|055|S|nausea/vomiting that doesn't stop, loss of appetite,||
1159|056|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
1159|057|S|bruising or bleeding.||
1159|058|S|   This medication may rarely cause a severe intestinal condition||
1159|059|S|due to a bacteria called C. difficile. This condition may occur||
1159|060|S|during treatment or weeks to months after treatment has stopped.||
1159|061|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1159|062|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1159|063|S|stool.||
1159|064|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1159|065|S|products because they may make symptoms worse.||
1159|066|S|   A very serious allergic reaction to this drug is rare.||
1159|067|S|However, get medical help right away if you notice any symptoms||
1159|068|S|of a serious allergic reaction, including: fever that doesn't go||
1159|069|S|away, new or worsening lymph node swelling, rash,||
1159|070|S|itching/swelling (especially of the face/tongue/throat), severe||
1159|071|S|dizziness, trouble breathing.||
1159|072|S|   Amoxicillin can commonly cause a mild rash that is usually not||
1159|073|S|serious. However, you may not be able to tell it apart from a||
1159|074|S|rare rash that could be a sign of a severe allergic reaction. Get||
1159|075|S|medical help right away if you develop any rash.||
1159|076|S|   This is not a complete list of possible side effects. If you||
1159|077|S|notice other effects not listed above, contact your doctor or||
1159|078|S|pharmacist.||
1159|079|S|   In the US -||
1159|080|S|   Call your doctor for medical advice about side effects. You||
1159|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1159|082|S|www.fda.gov/medwatch.||
1159|083|S|   In Canada - Call your doctor for medical advice about side||
1159|084|S|effects. You may report side effects to Health Canada at||
1159|085|S|1-866-234-2345.||
1159|086|B|||
1159|087|P|PRECAUTIONS:  Before taking amoxicillin, tell your doctor or||
1159|088|P|pharmacist if you are allergic to it; or to penicillin or||
1159|089|P|cephalosporin antibiotics; or if you have any other allergies.||
1159|090|P|This product may contain inactive ingredients, which can cause||
1159|091|P|allergic reactions or other problems. Talk to your pharmacist for||
1159|092|P|more details.||
1159|093|P|   Before using this medication, tell your doctor or pharmacist||
1159|094|P|your medical history, especially of: kidney disease, a certain||
1159|095|P|type of viral infection (infectious mononucleosis).||
1159|096|P|   Amoxicillin may cause live bacterial vaccines (such as typhoid||
1159|097|P|vaccine) to not work well. Tell your health care professional||
1159|098|P|that you are using amoxicillin before having any||
1159|099|P|immunizations/vaccinations.||
1159|100|P|   Before having surgery, tell your doctor or dentist about all||
1159|101|P|the products you use (including prescription drugs,||
1159|102|P|nonprescription drugs, and herbal products).||
1159|103|P|   During pregnancy, this medication should be used only when||
1159|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
1159|105|P|   Amoxicillin passes into breast milk. Consult your doctor||
1159|106|P|before breastfeeding.||
1159|107|B|||
1159|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1159|109|I|medications work or increase your risk for serious side effects.||
1159|110|I|This document does not contain all possible drug interactions.||
1159|111|I|Keep a list of all the products you use (including||
1159|112|I|prescription/nonprescription drugs and herbal products) and share||
1159|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
1159|114|I|the dosage of any medicines without your doctor's approval.||
1159|115|I|   A product that may interact with this drug is: methotrexate.||
1159|116|I|   This medication may interfere with certain lab tests (such as||
1159|117|I|certain diabetic urine tests), possibly causing false test||
1159|118|I|results. Make sure lab personnel and all your doctors know you||
1159|119|I|use this drug.||
1159|120|B|||
1159|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1159|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1159|123|O|poison control center right away. US residents can call||
1159|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1159|125|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
1159|126|O|severe vomiting, a severe decrease in the amount of urine, or||
1159|127|O|seizures.||
1159|128|B|||
1159|129|N|NOTES:  Do not share this medication with others.||
1159|130|N|   This medication has been prescribed for your current condition||
1159|131|N|only. Do not use it later for another infection unless your||
1159|132|N|doctor tells you to.||
1159|133|N|   With prolonged treatment, lab and/or medical tests (such as||
1159|134|N|kidney/liver function, complete blood counts) may be done while||
1159|135|N|you are taking this medication. Keep all medical and lab||
1159|136|N|appointments. Consult your doctor for more details.||
1159|137|B|||
1159|138|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1159|139|D|If it is near the time of the next dose, skip the missed dose.||
1159|140|D|Use your next dose at the regular time. Do not double the dose to||
1159|141|D|catch up.||
1159|142|B|||
1159|143|R|STORAGE:  Store at room temperature away from light and moisture.||
1159|144|R|Do not store in the bathroom. Keep all medications away from||
1159|145|R|children and pets.||
1159|146|R|   Do not flush medications down the toilet or pour them into a||
1159|147|R|drain unless instructed to do so. Properly discard this product||
1159|148|R|when it is expired or no longer needed. Consult your pharmacist||
1159|149|R|or local waste disposal company.||
1159|150|B|||
1159|151|A|Information last revised May 2024.||
1159|152|A|Copyright(c) 2025 First Databank, Inc.||
1159|153|B|||
1160|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1160|002|Z|does NOT have all possible information about this product. This||
1160|003|Z|information does not assure that this product is safe, effective,||
1160|004|Z|or appropriate for you. This information is not individual||
1160|005|Z|medical advice and does not substitute for the advice of your||
1160|006|Z|health care professional. Always ask your health care||
1160|007|Z|professional for complete information about this product and your||
1160|008|Z|specific health needs.||
1160|009|B|||
1160|010|T|RUFINAMIDE - ORAL||
1160|011|F|(roo-FIN-a-mide)||
1160|012|B|||
1160|013|C|COMMON BRAND NAME(S): Banzel||
1160|014|B|||
1160|015|U|USES:  Rufinamide is used with other medications to prevent or||
1160|016|U|control seizures (epilepsy) associated with Lennox-Gastaut||
1160|017|U|syndrome (LGS).||
1160|018|U|   This medication is an anticonvulsant. Rufinamide is thought to||
1160|019|U|work by acting on the sodium channels in the brain that carry||
1160|020|U|excessive electrical charges that may cause seizures.||
1160|021|B|||
1160|022|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1160|023|H|Instructions for Use provided by your pharmacist before you start||
1160|024|H|using rufinamide and each time you get a refill. If you have any||
1160|025|H|questions, consult your doctor or pharmacist.||
1160|026|H|   Take this medication by mouth with food as directed by your||
1160|027|H|doctor, usually twice daily. The dosage is based on your medical||
1160|028|H|condition and response to treatment. Children's dosage is also||
1160|029|H|based on weight.||
1160|030|H|   If you are using the suspension form of this medication, shake||
1160|031|H|the bottle well before each dose. Measure each dose carefully||
1160|032|H|with the provided oral dosing syringe. Do not use a household||
1160|033|H|spoon because you may not get the correct dose. Rinse the syringe||
1160|034|H|with tap water after each use.||
1160|035|H|   To reduce your risk of side effects, your doctor may direct||
1160|036|H|you to start this medication at a low dose and gradually increase||
1160|037|H|your dose. It is very important to follow your doctor's dosing||
1160|038|H|instructions exactly. It may take several weeks to reach the best||
1160|039|H|dose for you and to get the full benefit from this medication.||
1160|040|H|Take this medication regularly in order to get the most benefit||
1160|041|H|from it. To help you remember, take it at the same times each||
1160|042|H|day. This drug works best when the amount of medicine in your||
1160|043|H|body is kept at a constant level. It is best to take rufinamide||
1160|044|H|at evenly spaced intervals throughout the day and night.||
1160|045|H|   Do not stop taking this medication without consulting your||
1160|046|H|doctor. Some conditions (such as seizures) may become worse when||
1160|047|H|the drug is suddenly stopped. Your dose may need to be gradually||
1160|048|H|decreased.||
1160|049|H|   Tell your doctor if your condition does not get better or if||
1160|050|H|it gets worse.||
1160|051|B|||
1160|052|S|SIDE EFFECTS:  Drowsiness, dizziness, loss of coordination,||
1160|053|S|trouble walking, tiredness, headache, nausea, vomiting, loss of||
1160|054|S|appetite, or blurred/double vision may occur. If any of these||
1160|055|S|effects last or get worse, tell your doctor or pharmacist||
1160|056|S|promptly.||
1160|057|S|   Remember that this medication has been prescribed because your||
1160|058|S|doctor has judged that the benefit to you is greater than the||
1160|059|S|risk of side effects. Many people using this medication do not||
1160|060|S|have serious side effects.||
1160|061|S|   A small number of people who take anticonvulsants for any||
1160|062|S|condition (such as seizure, bipolar disorder, pain) may||
1160|063|S|experience depression, suicidal thoughts/attempts, or other||
1160|064|S|mental/mood problems. Tell your doctor right away if you or your||
1160|065|S|family/caregiver notice any unusual/sudden changes in your mood,||
1160|066|S|thoughts, or behavior including signs of depression, suicidal||
1160|067|S|thoughts/attempts, thoughts about harming yourself.||
1160|068|S|   A very serious allergic reaction to this drug is rare.||
1160|069|S|However, get medical help right away if you notice any symptoms||
1160|070|S|of a serious allergic reaction, including: fever, swollen lymph||
1160|071|S|nodes, rash, itching/swelling (especially of the||
1160|072|S|face/tongue/throat), severe dizziness, trouble breathing.||
1160|073|S|   This is not a complete list of possible side effects. If you||
1160|074|S|notice other effects not listed above, contact your doctor or||
1160|075|S|pharmacist.||
1160|076|S|   In the US -||
1160|077|S|   Call your doctor for medical advice about side effects. You||
1160|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1160|079|S|www.fda.gov/medwatch.||
1160|080|S|   In Canada - Call your doctor for medical advice about side||
1160|081|S|effects. You may report side effects to Health Canada at||
1160|082|S|1-866-234-2345.||
1160|083|B|||
1160|084|P|PRECAUTIONS:  Before taking rufinamide, tell your doctor or||
1160|085|P|pharmacist if you are allergic to it; or if you have any other||
1160|086|P|allergies. This product may contain inactive ingredients, which||
1160|087|P|can cause allergic reactions or other problems. Talk to your||
1160|088|P|pharmacist for more details.||
1160|089|P|   Before using this medication, tell your doctor or pharmacist||
1160|090|P|your medical history, especially of: family history of a certain||
1160|091|P|heart problem (QT shortening in the EKG), kidney disease, liver||
1160|092|P|disease, mental/mood disorders (such as depression, thoughts of||
1160|093|P|suicide).||
1160|094|P|   This drug may make you dizzy or drowsy or blur your vision. It||
1160|095|P|may also cause double vision. Alcohol or marijuana (cannabis) can||
1160|096|P|make you more dizzy or drowsy. Do not drive, use machinery, or do||
1160|097|P|anything that needs alertness or clear vision until you can do it||
1160|098|P|safely. Limit alcoholic beverages. Talk to your doctor if you are||
1160|099|P|using marijuana (cannabis).||
1160|100|P|   During pregnancy, this medication should be used only when||
1160|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
1160|102|P|   It is unknown if this medication passes into breast milk.||
1160|103|P|Consult your doctor before breastfeeding.||
1160|104|B|||
1160|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1160|106|I|medications work or increase your risk for serious side effects.||
1160|107|I|This document does not contain all possible drug interactions.||
1160|108|I|Keep a list of all the products you use (including||
1160|109|I|prescription/nonprescription drugs and herbal products) and share||
1160|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
1160|111|I|the dosage of any medicines without your doctor's approval.||
1160|112|I|   Some products that may interact with this drug are: orlistat,||
1160|113|I|valproate.||
1160|114|I|   This medication may decrease the effectiveness of hormonal||
1160|115|I|birth control such as pills, patch, or ring. This could cause||
1160|116|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1160|117|I|use reliable backup birth control methods while using this||
1160|118|I|medication. Also tell your doctor if you have any new spotting or||
1160|119|I|breakthrough bleeding, because these may be signs that your birth||
1160|120|I|control is not working well.||
1160|121|I|   Tell your doctor or pharmacist if you are taking other||
1160|122|I|products that cause drowsiness including alcohol, marijuana||
1160|123|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1160|124|I|drugs for sleep or anxiety (such as diazepam, triazolam,||
1160|125|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1160|126|I|codeine).||
1160|127|I|   Check the labels on all your medicines (such as allergy or||
1160|128|I|cough-and-cold products) because they may contain ingredients||
1160|129|I|that cause drowsiness. Ask your pharmacist about using those||
1160|130|I|products safely.||
1160|131|B|||
1160|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1160|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1160|134|O|poison control center right away. US residents can call||
1160|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1160|136|B|||
1160|137|N|NOTES:  Do not share this medication with others.||
1160|138|N|   Lab and/or medical tests (such as liver function, complete||
1160|139|N|blood counts) should be done while you are taking this||
1160|140|N|medication. Keep all medical and lab appointments. Consult your||
1160|141|N|doctor for more details.||
1160|142|B|||
1160|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1160|144|D|remember. If it is near the time of the next dose, skip the||
1160|145|D|missed dose. Take your next dose at the regular time. Do not||
1160|146|D|double the dose to catch up.||
1160|147|B|||
1160|148|R|STORAGE:  Store at room temperature away from light and moisture.||
1160|149|R|Do not store in the bathroom. If using the suspension, store the||
1160|150|R|bottle upright. Once the bottle for the suspension form is||
1160|151|R|opened, the medication expires after 90 days. Keep all||
1160|152|R|medications away from children and pets.||
1160|153|R|   Do not flush medications down the toilet or pour them into a||
1160|154|R|drain unless instructed to do so. Properly discard this product||
1160|155|R|when it is expired or no longer needed. Consult your pharmacist||
1160|156|R|or local waste disposal company.||
1160|157|B|||
1160|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
1160|159|M|medical emergency. For information about enrolling in MedicAlert,||
1160|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1160|161|B|||
1160|162|A|Information last revised November 2024.||
1160|163|A|Copyright(c) 2025 First Databank, Inc.||
1160|164|B|||
1161|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1161|002|Z|does NOT have all possible information about this product. This||
1161|003|Z|information does not assure that this product is safe, effective,||
1161|004|Z|or appropriate for you. This information is not individual||
1161|005|Z|medical advice and does not substitute for the advice of your||
1161|006|Z|health care professional. Always ask your health care||
1161|007|Z|professional for complete information about this product and your||
1161|008|Z|specific health needs.||
1161|009|B|||
1161|010|T|CARBIDOPA/LEVODOPA GEL - INTESTINAL||
1161|011|F|(KAR-bi-DOE-pa/LEE-voe-DOE-pa)||
1161|012|B|||
1161|013|U|USES:  This product is used to treat symptoms of Parkinson's||
1161|014|U|disease (such as shakiness, stiffness, difficulty moving). It is||
1161|015|U|used when the usual medications taken by mouth for Parkinson's||
1161|016|U|disease are not effective. Parkinson's disease is thought to be||
1161|017|U|caused by too little of a naturally occurring substance||
1161|018|U|(dopamine) in the brain. Levodopa changes into dopamine in the||
1161|019|U|brain, helping to control movement. Carbidopa prevents the||
1161|020|U|breakdown of levodopa in the bloodstream so more levodopa can||
1161|021|U|enter the brain. Carbidopa can also reduce some of levodopa's||
1161|022|U|side effects such as nausea and vomiting.||
1161|023|B|||
1161|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1161|025|H|from your pharmacist before you start using this product and each||
1161|026|H|time you get a refill. If you have any questions, ask your doctor||
1161|027|H|or pharmacist.||
1161|028|H|   This medication is given as a continuous infusion into the||
1161|029|H|small intestine using an infusion pump. It is given throughout||
1161|030|H|the day, usually stopping at bedtime. At bedtime, take your dose||
1161|031|H|of carbidopa/levodopa tablets by mouth as directed. This||
1161|032|H|medication can only be prescribed by doctors who have completed a||
1161|033|H|special program which explains the risks, benefits, and use of||
1161|034|H|this product. When you first start using this medication, it is||
1161|035|H|given through a tube through the nose into the small intestine.||
1161|036|H|After a few days, if the doctor decides that this product is||
1161|037|H|right for you, then the medication will be given through a tube||
1161|038|H|through the abdomen into the small intestine. The tube through||
1161|039|H|the abdomen will require surgery.||
1161|040|H|   Follow all instructions from your health care professional||
1161|041|H|about how to properly use and prepare this medication and the||
1161|042|H|infusion pump. The cassettes containing the medication should not||
1161|043|H|be used longer than 16 hours or re-used. Learn how to properly||
1161|044|H|care for the tube insertion site and how to avoid infection. Also||
1161|045|H|learn how to store and discard medical supplies safely. If you||
1161|046|H|have any questions about the use of this medication or the||
1161|047|H|infusion pump, consult your health care professional.||
1161|048|H|   The dosage is based on your medical condition and response to||
1161|049|H|treatment. Your daily dose is made up of a morning dose, a||
1161|050|H|continuous dose, and extra doses. An extra dose is a small dose||
1161|051|H|of this medication that can be given as needed during the day to||
1161|052|H|treat sudden "off" symptoms.||
1161|053|H|   It is best to avoid a high-protein diet (it decreases the||
1161|054|H|amount of levodopa that your body takes in) during treatment,||
1161|055|H|unless directed otherwise by your doctor. Separate your dose of||
1161|056|H|this medication by as many hours as possible from any iron||
1161|057|H|supplements or products containing iron (such as multivitamins||
1161|058|H|with minerals) you may take. Iron can reduce the amount of this||
1161|059|H|medication absorbed by the body. Consult your doctor or||
1161|060|H|pharmacist for more details.||
1161|061|H|   Do not stop using this medication without consulting your||
1161|062|H|doctor. Some conditions may become worse when this medication is||
1161|063|H|suddenly stopped. Also, if you suddenly stop using this||
1161|064|H|medication, you may have withdrawal symptoms (such as anxiety,||
1161|065|H|depression, confusion, fever, muscle stiffness). To help prevent||
1161|066|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1161|067|H|more likely if you have used this medication for a long time or||
1161|068|H|in high doses. Tell your doctor or pharmacist right away if you||
1161|069|H|have withdrawal.||
1161|070|H|   Tell your doctor if your condition does not get better or if||
1161|071|H|it gets worse, or if you need more than 5 extra doses of the||
1161|072|H|medication per day.||
1161|073|B|||
1161|074|S|SIDE EFFECTS:  Dizziness, lightheadedness, nausea, vomiting,||
1161|075|S|trouble sleeping, unusual dreams, or headache may occur. If any||
1161|076|S|of these effects last or get worse, tell your doctor or||
1161|077|S|pharmacist promptly.||
1161|078|S|   This medication may cause saliva, urine, or sweat to turn a||
1161|079|S|dark color. This effect is harmless, but your clothes may be||
1161|080|S|stained.||
1161|081|S|   To reduce the risk of dizziness and lightheadedness, get up||
1161|082|S|slowly when rising from a sitting or lying position.||
1161|083|S|   Remember that this medication has been prescribed because your||
1161|084|S|doctor has judged that the benefit to you is greater than the||
1161|085|S|risk of side effects. Many people using this medication do not||
1161|086|S|have serious side effects.||
1161|087|S|   Some people using this medication have fallen asleep suddenly||
1161|088|S|during their usual daily activities (such as talking on the||
1161|089|S|phone, driving). In some cases, sleep occurred without any||
1161|090|S|feelings of drowsiness beforehand. This sleep effect may occur||
1161|091|S|anytime during treatment with this medication even if you have||
1161|092|S|used this medication for a long time. If you experience increased||
1161|093|S|sleepiness or fall asleep during the day, do not drive or do||
1161|094|S|other possibly dangerous activities until you have discussed this||
1161|095|S|effect with your doctor. Your risk of this sleep effect is||
1161|096|S|increased by using alcohol or other medications that can make you||
1161|097|S|drowsy. See also Precautions section.||
1161|098|S|   Tell your doctor right away if you have any serious side||
1161|099|S|effects, including: new/worsening movements you can't||
1161|100|S|control/spasms, greatly increased eye blinking/twitching, vision||
1161|101|S|changes (such as blurred/double/decreased vision), eye pain,||
1161|102|S|mental/mood changes (such as confusion, agitation,||
1161|103|S|hallucinations), easy bruising/bleeding, unusual tiredness,||
1161|104|S|tingling/numbness/weakness of the hands/feet, unusual strong||
1161|105|S|urges (such as increased gambling, increased sexual urges).||
1161|106|S|   This medication may raise your blood pressure. Check your||
1161|107|S|blood pressure regularly and tell your doctor if the results are||
1161|108|S|high.||
1161|109|S|   Get medical help right away if you have any very serious side||
1161|110|S|effects, including: nausea/vomiting/constipation that doesn't go||
1161|111|S|away, vomit that looks like coffee grounds, bloody/black/tarry||
1161|112|S|stools, stomach/abdominal pain, signs of infection (such as sore||
1161|113|S|throat that doesn't go away, fever, chills),||
1161|114|S|redness/swelling/pain/oozing around the tube site, chest pain,||
1161|115|S|fainting.||
1161|116|S|   Abruptly stopping or reducing the dose of this medication may||
1161|117|S|rarely cause a very serious condition called neuroleptic||
1161|118|S|malignant syndrome (NMS). Get medical help right away if you have||
1161|119|S|any of the following symptoms: fever, unusual muscle stiffness,||
1161|120|S|severe confusion, sweating, fast/irregular heartbeat.||
1161|121|S|   A very serious allergic reaction to this drug is rare.||
1161|122|S|However, get medical help right away if you notice any symptoms||
1161|123|S|of a serious allergic reaction, including: rash, itching/swelling||
1161|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1161|125|S|breathing.||
1161|126|S|   This is not a complete list of possible side effects. If you||
1161|127|S|notice other effects not listed above, contact your doctor or||
1161|128|S|pharmacist.||
1161|129|S|   In the US -||
1161|130|S|   Call your doctor for medical advice about side effects. You||
1161|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1161|132|S|www.fda.gov/medwatch.||
1161|133|S|   In Canada - Call your doctor for medical advice about side||
1161|134|S|effects. You may report side effects to Health Canada at||
1161|135|S|1-866-234-2345.||
1161|136|B|||
1161|137|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1161|138|P|pharmacist if you are allergic to carbidopa or levodopa; or to||
1161|139|P|foscarbidopa or foslevodopa; or if you have any other allergies.||
1161|140|P|This product may contain inactive ingredients, which can cause||
1161|141|P|allergic reactions or other problems. Talk to your pharmacist for||
1161|142|P|more details.||
1161|143|P|   Before using this medication, tell your doctor or pharmacist||
1161|144|P|your medical history, especially of: liver disease, glaucoma,||
1161|145|P|breathing problems (such as asthma), heart disease (such as||
1161|146|P|irregular heartbeat, heart attack), kidney disease,||
1161|147|P|stomach/intestinal problems (such as ulcers, past||
1161|148|P|stomach/abdominal surgery, ileus), mental/mood disorders (such as||
1161|149|P|depression, schizophrenia), blood disorders, bleeding disorders,||
1161|150|P|seizures, sleep disorder, disease of the pancreas (pancreatitis),||
1161|151|P|high blood pressure, numbness/tingling of the hands/feet.||
1161|152|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1161|153|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1161|154|P|machinery, or do anything that needs alertness until you can do||
1161|155|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1161|156|P|are using marijuana (cannabis). See also Side Effects section.||
1161|157|P|   Before having surgery, tell your doctor or dentist about all||
1161|158|P|the products you use (including prescription drugs,||
1161|159|P|nonprescription drugs, and herbal products).||
1161|160|P|   During pregnancy, this medication should be used only when||
1161|161|P|clearly needed. Discuss the risks and benefits with your doctor.||
1161|162|P|   Levodopa passes into breast milk. It is unknown if carbidopa||
1161|163|P|passes into breast milk. Consult your doctor before||
1161|164|P|breastfeeding.||
1161|165|B|||
1161|166|I|DRUG INTERACTIONS:  See also How to Use section.||
1161|167|I|   Drug interactions may change how your medications work or||
1161|168|I|increase your risk for serious side effects. This document does||
1161|169|I|not contain all possible drug interactions. Keep a list of all||
1161|170|I|the products you use (including prescription/nonprescription||
1161|171|I|drugs and herbal products) and share it with your doctor and||
1161|172|I|pharmacist. Do not start, stop, or change the dosage of any||
1161|173|I|medicines without your doctor's approval.||
1161|174|I|   Taking MAO inhibitors with this medication may cause a serious||
1161|175|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1161|176|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1161|177|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
1161|178|I|treatment with this medication. Most MAO inhibitors should also||
1161|179|I|not be taken for two weeks before treatment with this medication.||
1161|180|I|However, certain MAO inhibitors (rasagiline, safinamide,||
1161|181|I|selegiline) may be used with careful monitoring by your doctor.||
1161|182|I|Ask your doctor when to start or stop taking this medication.||
1161|183|I|   This medication may interfere with certain lab tests (such as||
1161|184|I|urine catecholamine/glucose/ketone tests), possibly causing false||
1161|185|I|test results. Make sure lab personnel and all your doctors know||
1161|186|I|you use this drug.||
1161|187|B|||
1161|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1161|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1161|190|O|poison control center right away. US residents can call||
1161|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1161|192|O|Symptoms of overdose may include: severe dizziness, irregular||
1161|193|O|heartbeat, mental/mood changes (such as agitation).||
1161|194|B|||
1161|195|N|NOTES:  Do not share this medication with others.||
1161|196|N|   Lab and/or medical tests (such as complete blood count,||
1161|197|N|heart/kidney/liver function, blood pressure) should be done while||
1161|198|N|you are using this medication. Keep all medical and lab||
1161|199|N|appointments. Consult your doctor for more details.||
1161|200|B|||
1161|201|D|MISSED DOSE:  This drug is to be given continuously as an||
1161|202|D|infusion throughout the day, usually stopping at bedtime. If your||
1161|203|D|infusion is interrupted, contact your doctor or pharmacist right||
1161|204|D|away.||
1161|205|B|||
1161|206|R|STORAGE:  Store the cassettes in the refrigerator away from||
1161|207|R|light. Do not freeze. Keep the medication in the original carton||
1161|208|R|until ready for use. The gel in the cassette may become slightly||
1161|209|R|yellow when it is near its expiration date or when it has been||
1161|210|R|used for close to 16 hours. This is normal and will not affect||
1161|211|R|how the drug works. Keep all medications away from children and||
1161|212|R|pets.||
1161|213|R|   Do not flush medications down the toilet or pour them into a||
1161|214|R|drain unless instructed to do so. Properly discard this product||
1161|215|R|when it is expired or no longer needed. Consult your pharmacist||
1161|216|R|or local waste disposal company.||
1161|217|B|||
1161|218|A|Information last revised April 2025.||
1161|219|A|Copyright(c) 2025 First Databank, Inc.||
1161|220|B|||
1163|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1163|002|Z|does NOT have all possible information about this product. This||
1163|003|Z|information does not assure that this product is safe, effective,||
1163|004|Z|or appropriate for you. This information is not individual||
1163|005|Z|medical advice and does not substitute for the advice of your||
1163|006|Z|health care professional. Always ask your health care||
1163|007|Z|professional for complete information about this product and your||
1163|008|Z|specific health needs.||
1163|009|B|||
1163|010|T|ADAPALENE/BENZOYL PEROXIDE GEL - TOPICAL||
1163|011|F|(a-DAP-a-leen/BEN-zoe-il per-OX-ide)||
1163|012|B|||
1163|013|C|COMMON BRAND NAME(S): Epiduo||
1163|014|B|||
1163|015|U|USES:  This medication is used on the skin to treat acne. This||
1163|016|U|medication is a combination of adapalene (a retinoid) and benzoyl||
1163|017|U|peroxide (an antibiotic and skin-peeling agent). This product may||
1163|018|U|decrease the number and severity of acne pimples and promote||
1163|019|U|quick healing of pimples that do appear.||
1163|020|U|   Adapalene works by affecting the growth of cells and||
1163|021|U|decreasing swelling and inflammation. Benzoyl peroxide works by||
1163|022|U|reducing the amount of acne-causing bacteria and by causing the||
1163|023|U|skin to dry and peel off..||
1163|024|B|||
1163|025|H|HOW TO USE:  Wash your hands before applying this medication.||
1163|026|H|Gently clean the affected skin with a mild or soapless cleanser||
1163|027|H|and pat dry. Apply a thin layer of this medication as directed by||
1163|028|H|your doctor, usually once daily. Use your fingertips to apply a||
1163|029|H|small amount of medication (about the size of a pea) to the||
1163|030|H|affected areas of skin.||
1163|031|H|   Use this medication on the skin only. Do not apply to the||
1163|032|H|inner lip area, inside the nose/mouth, or on mucous membranes. Do||
1163|033|H|not apply to cut, scraped, sunburned or eczema-affected skin.||
1163|034|H|   Avoid getting this medication in your eyes. If this medication||
1163|035|H|gets into your eyes, flush with large amounts of water. Call your||
1163|036|H|doctor if eye irritation develops. Wash your hands after using||
1163|037|H|the medication to avoid accidentally getting it in your eyes.||
1163|038|H|   The dosage and treatment plan is based on your medical||
1163|039|H|condition and response to treatment.||
1163|040|H|   During the first few weeks of using adapalene, your acne might||
1163|041|H|appear worse because the medication is working on pimples forming||
1163|042|H|inside the skin.||
1163|043|H|   Use this medication regularly to get the most benefit from it.||
1163|044|H|To help you remember, use it at the same time each day. Do not||
1163|045|H|use a larger amount or use it more often than recommended. Your||
1163|046|H|skin will not improve any faster, and it will increase the risk||
1163|047|H|of developing redness, peeling, and pain.||
1163|048|H|   Tell your doctor if your condition does not get better or if||
1163|049|H|it gets worse.||
1163|050|H|   Since this drug is absorbed through the skin and may harm an||
1163|051|H|unborn baby, women who are pregnant or who may become pregnant||
1163|052|H|should not handle this medication.||
1163|053|B|||
1163|054|S|SIDE EFFECTS:  Skin redness, dryness, peeling, mild burning,||
1163|055|S|swelling, or worsening of acne may occur during the first 4 weeks||
1163|056|S|of using this product. These effects usually decrease with||
1163|057|S|continued use. If any of these effects last or get worse, notify||
1163|058|S|your doctor or pharmacist promptly. Your doctor may want you to||
1163|059|S|use a moisturizer, decrease how often you use the product, or||
1163|060|S|have you stop using it.||
1163|061|S|   Remember that this medication has been prescribed because your||
1163|062|S|doctor has judged that the benefit to you is greater than the||
1163|063|S|risk of side effects. Many people using this medication do not||
1163|064|S|have serious side effects.||
1163|065|S|   A very serious allergic reaction to this drug is rare.||
1163|066|S|However, get medical help right away if you notice any symptoms||
1163|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1163|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1163|069|S|breathing.||
1163|070|S|   This is not a complete list of possible side effects. If you||
1163|071|S|notice other effects not listed above, contact your doctor or||
1163|072|S|pharmacist.||
1163|073|S|   In the US -||
1163|074|S|   Call your doctor for medical advice about side effects. You||
1163|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1163|076|S|www.fda.gov/medwatch.||
1163|077|S|   In Canada - Call your doctor for medical advice about side||
1163|078|S|effects. You may report side effects to Health Canada at||
1163|079|S|1-866-234-2345.||
1163|080|B|||
1163|081|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1163|082|P|pharmacist if you are allergic to adapalene or benzoyl peroxide;||
1163|083|P|or to vitamin A-related drugs (other retinoids such as||
1163|084|P|isotretinoin); or if you have any other allergies. This product||
1163|085|P|may contain inactive ingredients, which can cause allergic||
1163|086|P|reactions or other problems. Talk to your pharmacist for more||
1163|087|P|details.||
1163|088|P|   Before using this medication, tell your doctor or pharmacist||
1163|089|P|your medical history, especially of: other skin conditions (such||
1163|090|P|as eczema).||
1163|091|P|   This drug may bleach hair or colored fabric (such as clothing,||
1163|092|P|bedding, and towels). Use caution when applying near the||
1163|093|P|hairline, while dressing, and while choosing towel and bed sheet||
1163|094|P|colors (if leaving on the skin overnight).||
1163|095|P|   This medication may make you more sensitive to the sun. Limit||
1163|096|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1163|097|P|sunscreen and wear protective clothing when outdoors. Tell your||
1163|098|P|doctor right away if you get sunburned or have skin||
1163|099|P|blisters/redness. Wait until your skin has completely recovered||
1163|100|P|from a sunburn before using this product. Weather extremes such||
1163|101|P|as wind or cold may also be irritating to the skin.||
1163|102|P|   Avoid electrolysis, waxing and chemical depilatories for hair||
1163|103|P|removal on the treated areas while using this product.||
1163|104|P|   Since this drug is absorbed through the skin and may harm an||
1163|105|P|unborn baby, women who are pregnant or who may become pregnant||
1163|106|P|should not handle this medication.||
1163|107|P|   Tell your doctor if you are pregnant or plan to become||
1163|108|P|pregnant. You should not become pregnant while using this||
1163|109|P|medication. Adapalene may harm an unborn baby. If you become||
1163|110|P|pregnant, talk to your doctor right away about the risks and||
1163|111|P|benefits of this medication.||
1163|112|P|   It is unknown if this drug passes into breast milk when used||
1163|113|P|on the skin. Consult your doctor before breastfeeding.||
1163|114|B|||
1163|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1163|116|I|medications work or increase your risk for serious side effects.||
1163|117|I|This document does not contain all possible drug interactions.||
1163|118|I|Keep a list of all the products you use (including||
1163|119|I|prescription/nonprescription drugs and herbal products) and share||
1163|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1163|121|I|the dosage of any medicines without your doctor's approval.||
1163|122|I|   Some products that may interact with this drug include: other||
1163|123|I|acne skin treatments (such as tretinoin, dapsone).||
1163|124|I|   Avoid using other skin products that are harsh, irritating, or||
1163|125|I|drying on the treated area. These products include hair perming||
1163|126|I|solutions, alcohol/lime/menthol-containing products (such as||
1163|127|I|astringents, toners, shaving lotion), medicated or abrasive soaps||
1163|128|I|or cleansers, soaps and cosmetics with a strong drying effect||
1163|129|I|(such as alpha hydroxy acids, glycolic acid), and products||
1163|130|I|containing sulfur, resorcinol, salicylic acid.||
1163|131|I|   If you have recently used products containing sulfur,||
1163|132|I|resorcinol or salicylic acid, use this product with caution. Wait||
1163|133|I|until the effects of such products on the skin have decreased||
1163|134|I|before using this product.||
1163|135|B|||
1163|136|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1163|137|O|has overdosed and has serious symptoms such as passing out or||
1163|138|O|trouble breathing, call 911. Otherwise, call a poison control||
1163|139|O|center right away. US residents can call 1-800-222-1222. Canada||
1163|140|O|residents can call 1-844-764-7669.||
1163|141|B|||
1163|142|N|NOTES:  Do not share this medication with others.||
1163|143|N|   Cosmetics may be used, but clean skin thoroughly before||
1163|144|N|applying the medication.||
1163|145|N|   Some cosmetics and soaps may worsen your acne. Moisturizers||
1163|146|N|may be safe to use. When buying cosmetics, moisturizers, or other||
1163|147|N|skin care products, check the label for "non-comedogenic" or||
1163|148|N|"non-acnegenic." These products are unlikely to worsen your acne.||
1163|149|N|Ask your doctor or pharmacist which products are safe to use.||
1163|150|N|Remember, acne is not caused by dirt. Cleaning your skin too||
1163|151|N|often or too vigorously can irritate your skin and worsen acne.||
1163|152|B|||
1163|153|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
1163|154|D|remember. If it is near the time of the next dose, skip the||
1163|155|D|missed dose. Use your next dose at the regular time. Do not||
1163|156|D|double the dose to catch up.||
1163|157|B|||
1163|158|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
1163|159|R|medications away from children and pets.||
1163|160|R|   Do not flush medications down the toilet or pour them into a||
1163|161|R|drain unless instructed to do so. Properly discard this product||
1163|162|R|when it is expired or no longer needed. Consult your pharmacist||
1163|163|R|or local waste disposal company.||
1163|164|B|||
1163|165|A|Information last revised October 2024.||
1163|166|A|Copyright(c) 2025 First Databank, Inc.||
1163|167|B|||
1164|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1164|002|Z|does NOT have all possible information about this product. This||
1164|003|Z|information does not assure that this product is safe, effective,||
1164|004|Z|or appropriate for you. This information is not individual||
1164|005|Z|medical advice and does not substitute for the advice of your||
1164|006|Z|health care professional. Always ask your health care||
1164|007|Z|professional for complete information about this product and your||
1164|008|Z|specific health needs.||
1164|009|B|||
1164|010|T|C1-ESTERASE INHIBITOR - INJECTION||
1164|011|B|||
1164|012|C|COMMON BRAND NAME(S): Cinryze||
1164|013|B|||
1164|014|U|USES:  This medication is used to help prevent swelling problems||
1164|015|U|that occur with a certain immune disease passed down through||
1164|016|U|families (hereditary angioedema-HAE). HAE is caused by low levels||
1164|017|U|or improper function of a natural substance produced by the body||
1164|018|U|(C1-inhibitor). Symptoms such as rapid swelling of the hands,||
1164|019|U|feet, limbs, face, tongue, or throat can occur. Swelling of the||
1164|020|U|intestinal tract may cause symptoms such as abdominal cramps,||
1164|021|U|diarrhea, or vomiting. Attacks of swelling may occur without||
1164|022|U|reason. However, anxiety, stress, sickness, and surgery may||
1164|023|U|trigger attacks in some people. This medication increases the||
1164|024|U|level of C1-inhibitor to help prevent attacks of sudden swelling||
1164|025|U|due to hereditary angioedema.||
1164|026|B|||
1164|027|H|HOW TO USE:  Read the Patient Information Leaflet and||
1164|028|H|Instructions for Use if available from your pharmacist before you||
1164|029|H|start using this medication and each time you get a refill. If||
1164|030|H|you have any questions, ask your doctor or pharmacist.||
1164|031|H|   This medication is given by injection into a vein as directed||
1164|032|H|by your doctor, usually every 3 or 4 days. The dosage is based on||
1164|033|H|your medical condition and response to treatment.||
1164|034|H|   If you are using this medication at home, learn all||
1164|035|H|preparation and usage instructions from your health care||
1164|036|H|professional. Before using, check this product for particles or||
1164|037|H|discoloration. If either is present, do not use the liquid. Learn||
1164|038|H|how to store and discard medical supplies safely.||
1164|039|H|   Use this medication regularly to get the most benefit from it.||
1164|040|H|   Tell your doctor if your condition does not get better or if||
1164|041|H|it gets worse.||
1164|042|B|||
1164|043|S|SIDE EFFECTS:  Headache may occur. Other side effects are||
1164|044|S|uncommon. If you notice any unusual side effects, tell your||
1164|045|S|doctor or pharmacist promptly.||
1164|046|S|   Remember that this medication has been prescribed because your||
1164|047|S|doctor has judged that the benefit to you is greater than the||
1164|048|S|risk of side effects. Many people using this medication do not||
1164|049|S|have serious side effects.||
1164|050|S|   This medication may rarely cause serious problems from blood||
1164|051|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1164|052|S|legs), especially when used at high doses. You may be at||
1164|053|S|increased risk for blood clots if you have a history of blood||
1164|054|S|clots, heart/blood vessel disease, heart failure, stroke, or if||
1164|055|S|you are immobile (such as on very long plane flights or being||
1164|056|S|bedridden). If you use estrogen-containing products, these may||
1164|057|S|also increase your risk. Before using this medication, if you||
1164|058|S|have any of these conditions report them to your doctor or||
1164|059|S|pharmacist. Get medical help right away if any of these side||
1164|060|S|effects occur: shortness of breath/rapid breathing,||
1164|061|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1164|062|S|dizziness/fainting, new pain/swelling/warmth in the groin/calf,||
1164|063|S|sudden/severe headaches, trouble speaking, weakness on one side||
1164|064|S|of the body, sudden vision changes.||
1164|065|S|   A very serious allergic reaction to this drug is rare.||
1164|066|S|However, get medical help right away if you notice any symptoms||
1164|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1164|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1164|069|S|breathing.||
1164|070|S|   This is not a complete list of possible side effects. If you||
1164|071|S|notice other effects not listed above, contact your doctor or||
1164|072|S|pharmacist.||
1164|073|S|   In the US -||
1164|074|S|   Call your doctor for medical advice about side effects. You||
1164|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1164|076|S|www.fda.gov/medwatch.||
1164|077|S|   In Canada - Call your doctor for medical advice about side||
1164|078|S|effects. You may report side effects to Health Canada at||
1164|079|S|1-866-234-2345.||
1164|080|B|||
1164|081|P|PRECAUTIONS:  Before using C1-inhibitor, tell your doctor or||
1164|082|P|pharmacist if you are allergic to it; or if you have any other||
1164|083|P|allergies. This product may contain inactive ingredients, which||
1164|084|P|can cause allergic reactions or other problems. Talk to your||
1164|085|P|pharmacist for more details.||
1164|086|P|   Before using this medication, tell your doctor or pharmacist||
1164|087|P|your medical history, especially of: blood clots (such as in the||
1164|088|P|lungs, legs).||
1164|089|P|   This medication is made from human blood. Even though the||
1164|090|P|blood is carefully tested and this medication goes through a||
1164|091|P|special manufacturing process, there is an extremely small chance||
1164|092|P|that you may get infections from the medication (for example,||
1164|093|P|virus infections such as hepatitis). Consult your doctor or||
1164|094|P|pharmacist for more information.||
1164|095|P|   Before having surgery, tell your doctor or dentist about all||
1164|096|P|the products you use (including prescription drugs,||
1164|097|P|nonprescription drugs, and herbal products).||
1164|098|P|   During pregnancy, this medication should be used only when||
1164|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
1164|100|P|   It is unknown if this drug passes into breast milk. Consult||
1164|101|P|your doctor before breastfeeding.||
1164|102|B|||
1164|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1164|104|I|medications work or increase your risk for serious side effects.||
1164|105|I|This document does not contain all possible drug interactions.||
1164|106|I|Keep a list of all the products you use (including||
1164|107|I|prescription/nonprescription drugs and herbal products) and share||
1164|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
1164|109|I|the dosage of any medicines without your doctor's approval.||
1164|110|B|||
1164|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1164|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1164|113|O|poison control center right away. US residents can call||
1164|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1164|115|B|||
1164|116|N|NOTES:  Do not share this medication with others.||
1164|117|N|   Before traveling, talk to your doctor to make sure you have||
1164|118|N|enough of this medication.||
1164|119|B|||
1164|120|D|MISSED DOSE:  It is important to get each dose of this medication||
1164|121|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1164|122|D|right away for a new dosing schedule. Do not double the dose to||
1164|123|D|catch up.||
1164|124|B|||
1164|125|R|STORAGE:  Store the unmixed vial in the refrigerator or at room||
1164|126|R|temperature. Do not freeze. Keep the medication in the original||
1164|127|R|carton to protect from light. After mixing, use this medication||
1164|128|R|right away or within 3 hours. Do not refrigerate the mixed||
1164|129|R|solution. Discard any unused portion. Keep all medications away||
1164|130|R|from children and pets.||
1164|131|R|   Do not flush medications down the toilet or pour them into a||
1164|132|R|drain unless instructed to do so. Properly discard this product||
1164|133|R|when it is expired or no longer needed. Consult your pharmacist||
1164|134|R|or local waste disposal company.||
1164|135|B|||
1164|136|A|Information last revised November 2024.||
1164|137|A|Copyright(c) 2025 First Databank, Inc.||
1164|138|B|||
1165|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1165|002|Z|does NOT have all possible information about this product. This||
1165|003|Z|information does not assure that this product is safe, effective,||
1165|004|Z|or appropriate for you. This information is not individual||
1165|005|Z|medical advice and does not substitute for the advice of your||
1165|006|Z|health care professional. Always ask your health care||
1165|007|Z|professional for complete information about this product and your||
1165|008|Z|specific health needs.||
1165|009|B|||
1165|010|T|DIPHTH/TETANUS/PERTUSS/HEP B/POLIO/HAEMOPH B VACCINE - INJECTION||
1165|011|F|(dif-THEER-ee-a/TET-a-nus/per-TUS-is/HEP-a-TYE-tis/POE-lee-oh/||
1165|012|F|HEE-moe-FIL-us vak-SEEN)||
1165|013|B|||
1165|014|C|COMMON BRAND NAME(S): Vaxelis||
1165|015|B|||
1165|016|U|USES:  This vaccine is used to help prevent diphtheria, tetanus||
1165|017|U|(lockjaw), pertussis (whooping cough), hepatitis B, polio, and||
1165|018|U|Haemophilus influenzae B infection. Vaccination is the best way||
1165|019|U|to protect against these life-threatening infections. This||
1165|020|U|vaccine works by increasing the body's natural defense (immunity)||
1165|021|U|against the bacteria/virus.||
1165|022|U|   This vaccine is usually given to infants and children.||
1165|023|U|   Vaccines may not fully protect everyone who receives them.||
1165|024|B|||
1165|025|H|HOW TO USE:  Read all vaccine information available from your||
1165|026|H|health care professional before receiving the vaccine. If you||
1165|027|H|have any questions, ask your health care professional.||
1165|028|H|   This vaccine is given by injection into a muscle by a health||
1165|029|H|care professional. It is given in the upper arm for children and||
1165|030|H|in the thigh for infants.||
1165|031|H|   Vaccines are usually given in a series of doses to provide the||
1165|032|H|best protection. Closely follow the vaccination schedule provided||
1165|033|H|by your health care professional. To help you remember, mark your||
1165|034|H|calendar with a reminder.||
1165|035|B|||
1165|036|S|SIDE EFFECTS:  Pain/swelling/redness at the injection site,||
1165|037|S|fever, irritability/crying, vomiting, loss of appetite, and||
1165|038|S|diarrhea may occur. If any of these effects last or get worse,||
1165|039|S|tell the health care professional promptly.||
1165|040|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1165|041|S|vision changes, or ringing in the ears just after getting a||
1165|042|S|vaccine injection. Tell the health care professional right away||
1165|043|S|if your child has any of these symptoms. Sitting or lying down||
1165|044|S|may help, since these symptoms usually don't last long.||
1165|045|S|   Remember that this vaccine has been prescribed because the||
1165|046|S|health care professional has judged that the benefit to your||
1165|047|S|child is greater than the risk of side effects. Many people using||
1165|048|S|this vaccine do not have serious side effects.||
1165|049|S|   Tell your health care professional right away if your child||
1165|050|S|has any serious side effects, including: high fever (105 degrees||
1165|051|S|F/40 degrees C or higher), nonstop crying (beginning within 48||
1165|052|S|hours of the injection and lasting longer than 3 hours),||
1165|053|S|seizures, little or no response to sound/touch, weak/floppy||
1165|054|S|muscles, severe pain/swelling at the injection site.||
1165|055|S|   A very serious allergic reaction to this vaccine is rare.||
1165|056|S|However, get medical help right away if you notice any symptoms||
1165|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1165|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1165|059|S|breathing.||
1165|060|S|   This is not a complete list of possible side effects. If you||
1165|061|S|notice other effects not listed above, contact the health care||
1165|062|S|professional.||
1165|063|S|   Contact the health care professional for medical advice about||
1165|064|S|side effects. The following numbers do not provide medical||
1165|065|S|advice, but in the US you may report side effects to the Vaccine||
1165|066|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1165|067|S|Canada, you may call the Vaccine Safety Section at Public Health||
1165|068|S|Agency of Canada at 1-866-844-0018.||
1165|069|B|||
1165|070|P|PRECAUTIONS:  Before your child receives this vaccine, tell the||
1165|071|P|health care professional if your child is allergic to it; or if||
1165|072|P|your child has any other allergies. This product may contain||
1165|073|P|inactive ingredients (such as neomycin, polymyxin B), which can||
1165|074|P|cause allergic reactions or other problems. Talk to your health||
1165|075|P|care professional for more details.||
1165|076|P|   Before receiving this vaccine, tell the health care||
1165|077|P|professional your child's medical history, especially of: current||
1165|078|P|fever/illness, nervous system disorders (such as seizures,||
1165|079|P|encephalopathy, Guillain-Barre syndrome), immune system disorders||
1165|080|P|(such as due to HIV infection, certain cancers such as||
1165|081|P|leukemia/lymphoma, cancer or radiation treatment), vaccination||
1165|082|P|history (including previous reactions to any vaccines).||
1165|083|P|   This vaccine is not usually used by adults. It is unlikely to||
1165|084|P|be used during pregnancy or breastfeeding. Consult the health||
1165|085|P|care professional if you have any questions about using this||
1165|086|P|vaccine.||
1165|087|B|||
1165|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1165|089|I|medications work or increase your risk for serious side effects.||
1165|090|I|This document does not contain all possible drug interactions.||
1165|091|I|Keep a list of all the products your child uses (including||
1165|092|I|prescription/nonprescription drugs and herbal products) and share||
1165|093|I|it with the health care professional. Do not start, stop, or||
1165|094|I|change the dosage of any medicines without the doctor's approval.||
1165|095|I|   Some products that may interact with this vaccine are: drugs||
1165|096|I|that weaken the immune system (including cyclosporine,||
1165|097|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1165|098|I|prednisone).||
1165|099|I|   This vaccine may interfere with certain lab tests (such as||
1165|100|I|antigen tests), possibly causing false test results. Make sure||
1165|101|I|lab personnel and all the doctors know your child recently||
1165|102|I|received this vaccine.||
1165|103|B|||
1165|104|O|OVERDOSE:  Not applicable.||
1165|105|B|||
1165|106|N|NOTES:  Keep all medical and lab appointments.||
1165|107|N|   Keep vaccine records for yourself and your children and||
1165|108|N|provide them to the health care professionals to prevent||
1165|109|N|unnecessary re-vaccinations.||
1165|110|B|||
1165|111|D|MISSED DOSE:  It is important that your child gets each||
1165|112|D|vaccination as scheduled. Ask when your child should get each||
1165|113|D|dose and mark your calendar with a reminder. If your child misses||
1165|114|D|a dose, call the health care professional to reschedule.||
1165|115|B|||
1165|116|R|STORAGE:  Store in the refrigerator away from light. Do not||
1165|117|R|freeze. Keep all medications away from children and pets.||
1165|118|R|   Do not flush medications down the toilet or pour them into a||
1165|119|R|drain unless instructed to do so. Properly discard this product||
1165|120|R|when it is expired or no longer needed. Consult your pharmacist||
1165|121|R|or local waste disposal company.||
1165|122|B|||
1165|123|A|Information last revised February 2025.||
1165|124|A|Copyright(c) 2025 First Databank, Inc.||
1165|125|B|||
1166|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1166|002|Z|does NOT have all possible information about this product. This||
1166|003|Z|information does not assure that this product is safe, effective,||
1166|004|Z|or appropriate for you. This information is not individual||
1166|005|Z|medical advice and does not substitute for the advice of your||
1166|006|Z|health care professional. Always ask your health care||
1166|007|Z|professional for complete information about this product and your||
1166|008|Z|specific health needs.||
1166|009|B|||
1166|010|T|BIMATOPROST SOLUTION - TOPICAL||
1166|011|F|(bye-MAT-oh-prost)||
1166|012|B|||
1166|013|C|COMMON BRAND NAME(S): Latisse||
1166|014|B|||
1166|015|U|USES:  This medication is used to treat patients with not enough||
1166|016|U|or inadequate eyelashes. Bimatoprost makes the eyelashes more||
1166|017|U|noticeable by causing more eyelashes to grow and making them||
1166|018|U|longer, thicker, and darker. Bimatoprost is similar to a natural||
1166|019|U|chemical in the body (prostaglandin).||
1166|020|U|   Bimatoprost is also used to treat glaucoma. If you are already||
1166|021|U|using or are directed to use bimatoprost to treat glaucoma, be||
1166|022|U|careful not to get this eyelash medication into your eyes.||
1166|023|U|Getting extra bimatoprost in your eyes may make it less effective||
1166|024|U|for treating glaucoma. Talk to your doctor or pharmacist for more||
1166|025|U|details.||
1166|026|B|||
1166|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1166|028|H|from your pharmacist before you start using bimatoprost and each||
1166|029|H|time you get a refill. Learn how to properly apply this||
1166|030|H|medication. If you have any questions, ask your doctor or||
1166|031|H|pharmacist.||
1166|032|H|   Use this medication as directed by your doctor, usually once||
1166|033|H|daily in the evening.||
1166|034|H|   To apply this medication, first wash your hands and face.||
1166|035|H|Remove any makeup and contact lenses. Contact lenses may be||
1166|036|H|reinserted 15 minutes after applying this medication. Place one||
1166|037|H|drop of this medication onto the provided applicator. Then right||
1166|038|H|away draw the applicator carefully across the skin of the upper||
1166|039|H|eyelid margin at the bottom of the eyelashes going from the inner||
1166|040|H|part of your lash line to the outer part. Blot any excess||
1166|041|H|solution that is applied beyond the eyelid margin. Throw away the||
1166|042|H|applicator after applying the medication. Repeat with a new||
1166|043|H|applicator for the other upper eyelid. This medication is not for||
1166|044|H|use on the lower eyelids.||
1166|045|H|   If any medication gets into the eye, do not rinse your eye. It||
1166|046|H|is not likely to cause any harm if this medication gets into the||
1166|047|H|eye, because it is the same medication that is used in the eyes||
1166|048|H|to treat glaucoma.||
1166|049|H|   To avoid contamination, do not touch the dropper tip or let it||
1166|050|H|touch your eyelashes or any other surface. Do not rinse the||
1166|051|H|dropper. Replace the dropper cap after each use, and keep the cap||
1166|052|H|tightly closed.||
1166|053|H|   Use this medication regularly to get the most benefit from it.||
1166|054|H|To help you remember, use it at the same time each evening. Do||
1166|055|H|not use more of this medication than recommended. Using more will||
1166|056|H|not make this medication work faster. It may take up to 2 months||
1166|057|H|before the full benefits of using this medication are seen.||
1166|058|H|   When this medication is stopped, expect the appearance of the||
1166|059|H|eyelashes to return to the way they looked before starting||
1166|060|H|treatment with bimatoprost.||
1166|061|H|   It is possible that the effects between your two sets of||
1166|062|H|eyelashes may not be the same. There may be differences in||
1166|063|H|eyelash length, thickness, fullness, color, number or direction||
1166|064|H|of growth. If any of these occur, talk to your doctor.||
1166|065|B|||
1166|066|S|SIDE EFFECTS:  Eye redness/discomfort/itching/dryness or eyelid||
1166|067|S|redness may occur. If any of these effects last or get worse,||
1166|068|S|tell your doctor or pharmacist promptly.||
1166|069|S|   It is possible for hair growth to happen in other areas of||
1166|070|S|your skin where this medication often touches. Be sure to wipe||
1166|071|S|any extra medication after applying it to the eyelash margins||
1166|072|S|(see also How to Use section).||
1166|073|S|   Remember that this medication has been prescribed because your||
1166|074|S|doctor has judged that the benefit to you is greater than the||
1166|075|S|risk of side effects. Many people using this medication do not||
1166|076|S|have serious side effects.||
1166|077|S|   When the eye drop form of this medication is applied directly||
1166|078|S|into the eyes to treat glaucoma, it may slowly (over months to||
1166|079|S|years) cause brown discoloration of the colored portion of the||
1166|080|S|eye (iris). This form of bimatoprost used to improve eyelash||
1166|081|S|appearance could also have this effect. Also, this medication may||
1166|082|S|cause eyelid changes or a darkening of the skin around the base||
1166|083|S|of the eyelashes. After stopping use, eyelid skin darkening||
1166|084|S|should go away after several weeks to months. However other side||
1166|085|S|effects (such as discoloration of the iris) may be permanent.||
1166|086|S|Tell your doctor if any of these side effects occur.||
1166|087|S|   Tell your doctor right away if you have any serious side||
1166|088|S|effects, including: eye pain, suspected eye infection (discharge,||
1166|089|S|unusual redness, swelling of eyes), rapid vision changes (such as||
1166|090|S|loss of vision).||
1166|091|S|   A very serious allergic reaction to this drug is rare.||
1166|092|S|However, get medical help right away if you notice any symptoms||
1166|093|S|of a serious allergic reaction, including: rash, itching/swelling||
1166|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1166|095|S|breathing.||
1166|096|S|   This is not a complete list of possible side effects. If you||
1166|097|S|notice other effects not listed above, contact your doctor or||
1166|098|S|pharmacist.||
1166|099|S|   In the US -||
1166|100|S|   Call your doctor for medical advice about side effects. You||
1166|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1166|102|S|www.fda.gov/medwatch.||
1166|103|S|   In Canada - Call your doctor for medical advice about side||
1166|104|S|effects. You may report side effects to Health Canada at||
1166|105|S|1-866-234-2345.||
1166|106|B|||
1166|107|P|PRECAUTIONS:  Before using bimatoprost, tell your doctor or||
1166|108|P|pharmacist if you are allergic to it; or to similar drugs (such||
1166|109|P|as latanoprost, travoprost); or if you have any other allergies.||
1166|110|P|This product may contain inactive ingredients (such as||
1166|111|P|preservatives like benzalkonium chloride), which can cause||
1166|112|P|allergic reactions or other problems (such as discoloration of||
1166|113|P|contact lenses). Talk to your pharmacist for more details.||
1166|114|P|   Before using this medication, tell your doctor or pharmacist||
1166|115|P|your medical history, especially of: eye pressure problems (such||
1166|116|P|as glaucoma), other eye problems (such as macular edema, iritis,||
1166|117|P|uveitis, lens extraction/aphakia).||
1166|118|P|   If you develop a new eye condition (such as infection, eye||
1166|119|P|surgery, eye injury) while using this medication, discuss with||
1166|120|P|your doctor whether you should start using a new bottle.||
1166|121|P|   If you are having your eye pressure tested, tell the testing||
1166|122|P|personnel (such as optometrist or ophthalmologist) that you are||
1166|123|P|using this medication.||
1166|124|P|   During pregnancy, this medication should be used only when||
1166|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
1166|126|P|   It is unknown if this drug passes into breast milk. Consult||
1166|127|P|your doctor before breastfeeding.||
1166|128|B|||
1166|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1166|130|I|medications work or increase your risk for serious side effects.||
1166|131|I|This document does not contain all possible drug interactions.||
1166|132|I|Keep a list of all the products you use (including||
1166|133|I|prescription/nonprescription drugs and herbal products) and share||
1166|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
1166|135|I|the dosage of any medicines without your doctor's approval.||
1166|136|I|   Some products that may interact with this drug are: certain||
1166|137|I|glaucoma eye drops (such as bimatoprost, latanoprost,||
1166|138|I|travoprost).||
1166|139|B|||
1166|140|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1166|141|O|has overdosed and has serious symptoms such as passing out or||
1166|142|O|trouble breathing, call 911. Otherwise, call a poison control||
1166|143|O|center right away. US residents can call 1-800-222-1222. Canada||
1166|144|O|residents can call 1-844-764-7669.||
1166|145|B|||
1166|146|N|NOTES:  Do not share this medication with others.||
1166|147|N|   This medication has been prescribed for your current condition||
1166|148|N|only. Do not use it for another condition unless told to do so by||
1166|149|N|your doctor.||
1166|150|B|||
1166|151|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1166|152|D|next dose at the regular time. Do not double the dose to catch||
1166|153|D|up.||
1166|154|B|||
1166|155|R|STORAGE:  Store in the refrigerator or at room temperature. Keep||
1166|156|R|all medications away from children and pets.||
1166|157|R|   Do not flush medications down the toilet or pour them into a||
1166|158|R|drain unless instructed to do so. Properly discard this product||
1166|159|R|when it is expired or no longer needed. Consult your pharmacist||
1166|160|R|or local waste disposal company.||
1166|161|B|||
1166|162|A|Information last revised May 2024.||
1166|163|A|Copyright(c) 2025 First Databank, Inc.||
1166|164|B|||
1168|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1168|002|Z|does NOT have all possible information about this product. This||
1168|003|Z|information does not assure that this product is safe, effective,||
1168|004|Z|or appropriate for you. This information is not individual||
1168|005|Z|medical advice and does not substitute for the advice of your||
1168|006|Z|health care professional. Always ask your health care||
1168|007|Z|professional for complete information about this product and your||
1168|008|Z|specific health needs.||
1168|009|B|||
1168|010|T|LABETALOL - ORAL||
1168|011|F|(luh-BET-uh-lol)||
1168|012|B|||
1168|013|C|COMMON BRAND NAME(S): Normodyne, Trandate||
1168|014|B|||
1168|015|W|WARNING:  Do not stop taking this medication without consulting||
1168|016|W|your doctor. Some conditions may become worse when you suddenly||
1168|017|W|stop this drug. Some people who have suddenly stopped taking||
1168|018|W|similar drugs have had chest pain, heart attack, and irregular||
1168|019|W|heartbeat. If your doctor decides you should no longer use this||
1168|020|W|drug, your doctor may direct you to gradually decrease your dose||
1168|021|W|over 1 to 2 weeks.||
1168|022|W|   When gradually stopping this medication, it is recommended||
1168|023|W|that you temporarily limit physical activity to decrease strain||
1168|024|W|on the heart. Get medical help right away if you develop chest||
1168|025|W|pain/tightness/pressure, chest pain spreading to the||
1168|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
1168|027|W|fast/irregular heartbeat.||
1168|028|B|||
1168|029|U|USES:  Labetalol is used with or without other medications to||
1168|030|U|treat high blood pressure (hypertension). Lowering high blood||
1168|031|U|pressure helps prevent strokes, heart attacks, and kidney||
1168|032|U|problems.||
1168|033|U|   This medication is both an alpha blocker and beta blocker. It||
1168|034|U|works by blocking the action of certain natural chemicals in your||
1168|035|U|body such as epinephrine on the heart and blood vessels. This||
1168|036|U|effect lowers the heart rate, blood pressure, and strain on the||
1168|037|U|heart.||
1168|038|B|||
1168|039|H|HOW TO USE:  See also Warning section.||
1168|040|H|   Take this medication by mouth as directed by your doctor,||
1168|041|H|usually twice a day. You may take this medication with or without||
1168|042|H|food, but it is important to choose one way and take this||
1168|043|H|medication the same way with every dose.||
1168|044|H|   The dosage is based on your medical condition and response to||
1168|045|H|treatment. To reduce your risk of side effects, your doctor may||
1168|046|H|direct you to start this medication at a low dose and gradually||
1168|047|H|increase your dose. Follow your doctor's instructions carefully.||
1168|048|H|   Use this medication regularly to get the most benefit from it.||
1168|049|H|To help you remember, take it at the same times each day.||
1168|050|H|   For the treatment of high blood pressure, it may take several||
1168|051|H|weeks before you get the full benefit of this drug. Keep taking||
1168|052|H|this medication even if you feel well. Most people with high||
1168|053|H|blood pressure do not feel sick.||
1168|054|H|   Tell your doctor if your condition does not get better or if||
1168|055|H|it gets worse (your blood pressure readings remain high or||
1168|056|H|increase).||
1168|057|B|||
1168|058|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
1168|059|S|   Dizziness and tiredness may occur. Scalp tingling may also||
1168|060|S|occur as your body adjusts to the medication. Decreased sexual||
1168|061|S|ability has been reported rarely. If any of these effects last or||
1168|062|S|get worse, tell your doctor or pharmacist promptly.||
1168|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
1168|064|S|slowly when rising from a sitting or lying position.||
1168|065|S|   This drug may reduce blood flow to your hands and feet,||
1168|066|S|causing them to feel cold. Smoking may worsen this effect. Dress||
1168|067|S|warmly and avoid tobacco use.||
1168|068|S|   Remember that this medication has been prescribed because your||
1168|069|S|doctor has judged that the benefit to you is greater than the||
1168|070|S|risk of side effects. Many people using this medication do not||
1168|071|S|have serious side effects.||
1168|072|S|   Tell your doctor right away if you have any serious side||
1168|073|S|effects, including: very slow heartbeat, fainting, blue||
1168|074|S|fingers/toes, new or worsening symptoms of heart failure (such as||
1168|075|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
1168|076|S|unusual/sudden weight gain), mental/mood changes (such as||
1168|077|S|confusion, mood swings, depression).||
1168|078|S|   This drug may rarely cause serious (rarely fatal) liver||
1168|079|S|disease. If you notice any of the following rare but serious side||
1168|080|S|effects, get medical help right away: nausea/vomiting that||
1168|081|S|doesn't stop, severe stomach/abdominal pain, yellowing eyes/skin,||
1168|082|S|dark urine.||
1168|083|S|   A very serious allergic reaction to this drug is rare.||
1168|084|S|However, get medical help right away if you notice any symptoms||
1168|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1168|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1168|087|S|breathing.||
1168|088|S|   This is not a complete list of possible side effects. If you||
1168|089|S|notice other effects not listed above, contact your doctor or||
1168|090|S|pharmacist.||
1168|091|S|   In the US -||
1168|092|S|   Call your doctor for medical advice about side effects. You||
1168|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1168|094|S|www.fda.gov/medwatch.||
1168|095|S|   In Canada - Call your doctor for medical advice about side||
1168|096|S|effects. You may report side effects to Health Canada at||
1168|097|S|1-866-234-2345.||
1168|098|B|||
1168|099|P|PRECAUTIONS:  Before taking labetalol, tell your doctor or||
1168|100|P|pharmacist if you are allergic to it; or if you have any other||
1168|101|P|allergies. This product may contain inactive ingredients, which||
1168|102|P|can cause allergic reactions or other problems. Talk to your||
1168|103|P|pharmacist for more details.||
1168|104|P|   Before using this medication, tell your doctor or pharmacist||
1168|105|P|your medical history, especially of: heart problems (such as||
1168|106|P|heart failure, slow heartbeat, second- or third-degree||
1168|107|P|atrioventricular block), breathing problems (such as asthma,||
1168|108|P|chronic bronchitis, emphysema), kidney disease, liver disease,||
1168|109|P|overactive thyroid disease (hyperthyroidism), serious allergic||
1168|110|P|reactions including those needing treatment with epinephrine,||
1168|111|P|blood circulation problems (such as Raynaud's disease, peripheral||
1168|112|P|vascular disease), mental/mood disorders (such as depression), a||
1168|113|P|certain muscle disease (myasthenia gravis), certain eye problems||
1168|114|P|(cataracts, glaucoma).||
1168|115|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1168|116|P|can make you more dizzy. Do not drive, use machinery, or do||
1168|117|P|anything that needs alertness until you can do it safely. Limit||
1168|118|P|alcoholic beverages. Talk to your doctor if you are using||
1168|119|P|marijuana (cannabis).||
1168|120|P|   Before having surgery (including cataract/glaucoma eye||
1168|121|P|surgery), tell your doctor or dentist if you are taking or have||
1168|122|P|ever taken this medication, and about all the other products you||
1168|123|P|use (including prescription drugs, nonprescription drugs, and||
1168|124|P|herbal products).||
1168|125|P|   This product may prevent the fast/pounding heartbeat you would||
1168|126|P|usually feel when your blood sugar level falls too low||
1168|127|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
1168|128|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
1168|129|P|blood sugar level, such as dizziness and sweating, are not||
1168|130|P|affected by this drug.||
1168|131|P|   If you have diabetes, this product may make it harder to||
1168|132|P|control your blood sugar levels. Check your blood sugar levels||
1168|133|P|regularly as directed by your doctor. Tell your doctor right away||
1168|134|P|if you have symptoms of high blood sugar such as increased||
1168|135|P|thirst/urination. Your doctor may need to adjust your diabetes||
1168|136|P|medication, exercise program, or diet.||
1168|137|P|   Children may be at greater risk for low blood sugar||
1168|138|P|(hypoglycemia) while using this drug, especially if they are||
1168|139|P|vomiting or not eating regularly. To help prevent low blood||
1168|140|P|sugar, make sure children eat regularly. If your child cannot eat||
1168|141|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
1168|142|P|as sweating, shaking), tell the doctor right away.||
1168|143|P|   Older adults may be more sensitive to the side effects of this||
1168|144|P|drug, including dizziness and lightheadedness. These side effects||
1168|145|P|can increase the risk of falling.||
1168|146|P|   Labetalol has been used to treat high blood pressure in||
1168|147|P|pregnant women. It is important to control high blood pressure||
1168|148|P|for the health of the mother and unborn baby. If you are planning||
1168|149|P|pregnancy, become pregnant, or think you may be pregnant, discuss||
1168|150|P|with your doctor the benefits and risks of using this medication||
1168|151|P|during pregnancy. Rarely, babies born to mothers who took||
1168|152|P|labetalol during pregnancy may have symptoms of low blood||
1168|153|P|pressure, slow heartbeat, slow breathing, and low blood sugar||
1168|154|P|(such as shaking, unusual sweating) for a few days after||
1168|155|P|delivery. Tell the doctor right away if you notice any of these||
1168|156|P|symptoms in your newborn.||
1168|157|P|   This medication passes into breast milk, and the effect on a||
1168|158|P|nursing infant is unknown. Consult your doctor before||
1168|159|P|breastfeeding.||
1168|160|B|||
1168|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1168|162|I|medications work or increase your risk for serious side effects.||
1168|163|I|This document does not contain all possible drug interactions.||
1168|164|I|Keep a list of all the products you use (including||
1168|165|I|prescription/nonprescription drugs and herbal products) and share||
1168|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
1168|167|I|the dosage of any medicines without your doctor's approval.||
1168|168|I|   Some products that may interact with this drug include:||
1168|169|I|cimetidine, diltiazem, fingolimod, verapamil.||
1168|170|I|   Some products have ingredients that could raise your heart||
1168|171|I|rate or blood pressure. Tell your pharmacist what products you||
1168|172|I|are using, and ask how to use them safely (especially||
1168|173|I|cough-and-cold products, diet aids, or NSAIDs such as||
1168|174|I|ibuprofen/naproxen).||
1168|175|I|   This medication may interfere with certain medical/lab tests,||
1168|176|I|possibly causing false test results. Make sure lab personnel and||
1168|177|I|all your doctors know you use this drug.||
1168|178|B|||
1168|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1168|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1168|181|O|poison control center right away. US residents can call||
1168|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1168|183|O|Symptoms of overdose may include: very slow heartbeat, severe||
1168|184|O|dizziness, severe weakness, fainting, trouble breathing.||
1168|185|B|||
1168|186|N|NOTES:  Do not share this medication with others.||
1168|187|N|   Talk with your doctor about making changes to your lifestyle||
1168|188|N|that may help this medication work better (such as stress||
1168|189|N|reduction programs, exercise, and dietary changes).||
1168|190|N|   Have your blood pressure and pulse (heart rate) checked||
1168|191|N|regularly while taking this medication. Learn how to check your||
1168|192|N|own blood pressure and pulse at home, and share the results with||
1168|193|N|your doctor.||
1168|194|N|   Lab and/or medical tests (such as liver function) should be||
1168|195|N|done while you are taking this medication. Keep all medical and||
1168|196|N|lab appointments. Consult your doctor for more details.||
1168|197|B|||
1168|198|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1168|199|D|remember. If it is near the time of the next dose, skip the||
1168|200|D|missed dose. Take your next dose at the regular time. Do not||
1168|201|D|double the dose to catch up.||
1168|202|B|||
1168|203|R|STORAGE:  Store at room temperature away from light and moisture.||
1168|204|R|Do not store in the bathroom. Keep all medications away from||
1168|205|R|children and pets.||
1168|206|R|   Do not flush medications down the toilet or pour them into a||
1168|207|R|drain unless instructed to do so. Properly discard this product||
1168|208|R|when it is expired or no longer needed. Consult your pharmacist||
1168|209|R|or local waste disposal company.||
1168|210|B|||
1168|211|A|Information last revised May 2024.||
1168|212|A|Copyright(c) 2025 First Databank, Inc.||
1168|213|B|||
1169|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1169|002|Z|does NOT have all possible information about this product. This||
1169|003|Z|information does not assure that this product is safe, effective,||
1169|004|Z|or appropriate for you. This information is not individual||
1169|005|Z|medical advice and does not substitute for the advice of your||
1169|006|Z|health care professional. Always ask your health care||
1169|007|Z|professional for complete information about this product and your||
1169|008|Z|specific health needs.||
1169|009|B|||
1169|010|T|POLIOVIRUS VACCINE - INJECTION||
1169|011|F|(POE-lee-oh)||
1169|012|B|||
1169|013|C|COMMON BRAND NAME(S): Ipol||
1169|014|B|||
1169|015|U|USES:  This vaccine is used to help prevent polio. Polio is a||
1169|016|U|disease caused by a virus that affects mainly young children. It||
1169|017|U|can be spread by person-to-person contact or by eating/drinking||
1169|018|U|contaminated food or water. Most people who get infected with||
1169|019|U|polio have mild or no symptoms. However, some infections can be||
1169|020|U|very serious and can cause inability to move (paralysis) in part||
1169|021|U|of the body, such as the arms, legs, or breathing muscles.||
1169|022|U|Vaccination is the best way to protect against this||
1169|023|U|life-threatening disease. This vaccine works by increasing the||
1169|024|U|body's natural defense (immunity) against the virus.||
1169|025|U|   Polio vaccine is usually given to infants and children. It may||
1169|026|U|also be given to adults who haven't been immunized or who may be||
1169|027|U|at increased risk for polio infection (for example, traveling to||
1169|028|U|countries where polio is common).||
1169|029|U|   Vaccines may not fully protect everyone who receives them.||
1169|030|B|||
1169|031|H|HOW TO USE:  Read all vaccine information available from your||
1169|032|H|health care professional before receiving the vaccine. If you||
1169|033|H|have any questions, ask your health care professional.||
1169|034|H|   This vaccine is given by injection into a muscle or under the||
1169|035|H|skin by a health care professional. It is given in the upper arm||
1169|036|H|for children and adults and in the thigh for infants.||
1169|037|H|   Vaccines are usually given in a series of doses to provide the||
1169|038|H|best protection. Closely follow the vaccination schedule provided||
1169|039|H|by your health care professional. To help you remember, mark your||
1169|040|H|calendar with a reminder.||
1169|041|H|   This vaccine may be given at the same time as other vaccines.||
1169|042|B|||
1169|043|S|SIDE EFFECTS:  Redness/swelling/tenderness at the injection site,||
1169|044|S|fever, irritability, and tiredness may occur. If any of these||
1169|045|S|effects last or get worse, tell your health care professional||
1169|046|S|promptly.||
1169|047|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1169|048|S|vision changes, or ringing in the ears just after getting a||
1169|049|S|vaccine injection. Tell your health care professional right away||
1169|050|S|if you have any of these symptoms. Sitting or lying down may||
1169|051|S|help, since these symptoms usually don't last long.||
1169|052|S|   Remember that this vaccine has been prescribed because your||
1169|053|S|health care professional has judged that the benefit to you is||
1169|054|S|greater than the risk of side effects. Many people using this||
1169|055|S|vaccine do not have serious side effects.||
1169|056|S|   A very serious allergic reaction to this vaccine is rare.||
1169|057|S|However, get medical help right away if you notice any symptoms||
1169|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1169|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1169|060|S|breathing.||
1169|061|S|   This is not a complete list of possible side effects. If you||
1169|062|S|notice other effects not listed above, contact your health care||
1169|063|S|professional.||
1169|064|S|   Contact the health care professional for medical advice about||
1169|065|S|side effects. The following numbers do not provide medical||
1169|066|S|advice, but in the US you may report side effects to the Vaccine||
1169|067|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1169|068|S|Canada, you may call the Vaccine Safety Section at Public Health||
1169|069|S|Agency of Canada at 1-866-844-0018.||
1169|070|B|||
1169|071|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
1169|072|P|care professional if you are allergic to it; or if you have any||
1169|073|P|other allergies. This product may contain inactive ingredients||
1169|074|P|(such as neomycin, streptomycin, polymyxin B, 2-phenoxyethanol,||
1169|075|P|formaldehyde), which can cause allergic reactions or other||
1169|076|P|problems. Talk to your health care professional for more details.||
1169|077|P|   Before receiving this vaccine, tell your health care||
1169|078|P|professional your medical history, especially of: current||
1169|079|P|fever/illness, immune system disorders (such as due to HIV||
1169|080|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
1169|081|P|radiation treatment), vaccination history (including previous||
1169|082|P|reactions to any vaccines).||
1169|083|P|   During pregnancy, this vaccine should be used only when||
1169|084|P|clearly needed. Discuss the risks and benefits with your health||
1169|085|P|care professional.||
1169|086|P|   It is unknown if this vaccine passes into breast milk. Consult||
1169|087|P|your health care professional before breastfeeding.||
1169|088|B|||
1169|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1169|090|I|medications work or increase your risk for serious side effects.||
1169|091|I|This document does not contain all possible drug interactions.||
1169|092|I|Keep a list of all the products you use (including||
1169|093|I|prescription/nonprescription drugs and herbal products) and share||
1169|094|I|it with your health care professional. Do not start, stop, or||
1169|095|I|change the dosage of any medicines without your doctor's||
1169|096|I|approval.||
1169|097|I|   Some products that may interact with this vaccine are: drugs||
1169|098|I|that weaken the immune system (including cyclosporine,||
1169|099|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1169|100|I|prednisone).||
1169|101|B|||
1169|102|O|OVERDOSE:  Not applicable.||
1169|103|B|||
1169|104|N|NOTES:  Keep all medical and lab appointments.||
1169|105|N|   Keep vaccine records for yourself and your children and||
1169|106|N|provide them to the health care professionals to prevent||
1169|107|N|unnecessary re-vaccinations.||
1169|108|B|||
1169|109|D|MISSED DOSE:  It is important that you get each vaccination as||
1169|110|D|scheduled. Ask when you should get each dose and mark your||
1169|111|D|calendar with a reminder. If you miss a dose, call the health||
1169|112|D|care professional to reschedule.||
1169|113|B|||
1169|114|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
1169|115|R|light. Keep all medications away from children and pets.||
1169|116|R|   Do not flush medications down the toilet or pour them into a||
1169|117|R|drain unless instructed to do so. Properly discard this product||
1169|118|R|when it is expired or no longer needed. Consult your pharmacist||
1169|119|R|or local waste disposal company.||
1169|120|B|||
1169|121|A|Information last revised January 2025.||
1169|122|A|Copyright(c) 2025 First Databank, Inc.||
1169|123|B|||
1170|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1170|002|Z|does NOT have all possible information about this product. This||
1170|003|Z|information does not assure that this product is safe, effective,||
1170|004|Z|or appropriate for you. This information is not individual||
1170|005|Z|medical advice and does not substitute for the advice of your||
1170|006|Z|health care professional. Always ask your health care||
1170|007|Z|professional for complete information about this product and your||
1170|008|Z|specific health needs.||
1170|009|B|||
1170|010|T|PRAMOXINE/HYDROCORTISONE AEROSOL FOAM - RECTAL||
1170|011|F|(pram-OX-een/hi-dro-KOR-tih-sown)||
1170|012|B|||
1170|013|C|COMMON BRAND NAME(S): Proctofoam-HC||
1170|014|B|||
1170|015|U|USES:  This combination medication is used to treat minor pain,||
1170|016|U|itching, swelling, and discomfort caused by hemorrhoids and other||
1170|017|U|problems of the anal area (such as anal fissures). This||
1170|018|U|medication contains pramoxine, an anesthetic that works by||
1170|019|U|temporarily numbing the area. This product also contains||
1170|020|U|hydrocortisone, a corticosteroid that reduces redness, itching,||
1170|021|U|and swelling.||
1170|022|B|||
1170|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1170|024|H|from your pharmacist before you start using this product and each||
1170|025|H|time you get a refill. If you have any questions, ask your doctor||
1170|026|H|or pharmacist.||
1170|027|H|   If possible, clean the affected area with mild soap and water,||
1170|028|H|rinse well, and pat dry. Shake the foam canister well before||
1170|029|H|using. After filling the applicator, hold it by the barrel and||
1170|030|H|gently insert the applicator tip just 1/2 to 1 inch (1.5 to 2.5||
1170|031|H|centimeters) inside the anus. Push the plunger to release the||
1170|032|H|foam, then gently withdraw the applicator. Take the applicator||
1170|033|H|apart and clean it thoroughly with warm water. Do not insert any||
1170|034|H|part of the foam canister into the anus, and do not insert the||
1170|035|H|applicator more than 1/2 to 1 inch (1.5 to 2.5 centimeters)||
1170|036|H|inside the anus. Do not use your finger or a tissue to apply this||
1170|037|H|product inside the anus.||
1170|038|H|   To apply the product to the outside of the anus, spray a small||
1170|039|H|amount of foam onto a tissue and gently pat onto the affected||
1170|040|H|area. Do not cover the area with plastic or waterproof bandages||
1170|041|H|unless directed to do so by your doctor. Covering the treated||
1170|042|H|area may increase the absorption of the medication through the||
1170|043|H|skin. This may improve how well the drug works, but it may also||
1170|044|H|increase the risk of side effects.||
1170|045|H|   Wash hands immediately after use. Avoid getting the product in||
1170|046|H|your eyes, nose, ears or mouth. If the medication gets in these||
1170|047|H|areas, rinse the area immediately with clean water.||
1170|048|H|   Use this product as directed by your doctor, usually 3 to 4||
1170|049|H|times daily, or after each bowel movement. The dosage is based on||
1170|050|H|your medical condition and response to treatment. Use this||
1170|051|H|medication regularly in order to get the most benefit from it. To||
1170|052|H|help you remember, use it at the same times each day.||
1170|053|H|   Do not use more of this product, use it more often, or keep||
1170|054|H|using it longer than prescribed by your doctor. If you have been||
1170|055|H|using this medication for a long time or in high doses, do not||
1170|056|H|suddenly stop using it without your doctor's approval. Some||
1170|057|H|conditions may become worse when this drug is suddenly stopped.||
1170|058|H|Your dose may need to be gradually decreased.||
1170|059|H|   Tell your doctor if your condition does not get better or if||
1170|060|H|it gets worse after 2 to 3 weeks.||
1170|061|B|||
1170|062|S|SIDE EFFECTS:  Redness, burning, or itching at the application||
1170|063|S|site may occur. If any of these effects last or get worse,||
1170|064|S|contact your doctor or pharmacist promptly.||
1170|065|S|   Remember that this medication has been prescribed because your||
1170|066|S|doctor has judged that the benefit to you is greater than the||
1170|067|S|risk of side effects. Many people using this medication do not||
1170|068|S|have serious side effects.||
1170|069|S|   Tell your doctor right away if you have any serious side||
1170|070|S|effects, including: rectal bleeding, change in skin appearance||
1170|071|S|(such as color, thickness), skin redness/tenderness/pus, signs of||
1170|072|S|infection (such as sore throat that doesn't go away, fever,||
1170|073|S|chills).||
1170|074|S|   Rarely, it is possible this medication will be absorbed into||
1170|075|S|the bloodstream. This can lead to side effects of too much||
1170|076|S|corticosteroid. These side effects are more likely in children||
1170|077|S|and people who use this medication for a long time. Tell your||
1170|078|S|doctor right away if any of the following side effects occur:||
1170|079|S|unusual/extreme tiredness, weight loss, headache, swelling||
1170|080|S|ankles/feet, increased thirst/urination, vision problems.||
1170|081|S|   A very serious allergic reaction to this drug is rare.||
1170|082|S|However, get medical help right away if you notice any symptoms||
1170|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1170|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1170|085|S|breathing.||
1170|086|S|   This is not a complete list of possible side effects. If you||
1170|087|S|notice other effects not listed above, contact your doctor or||
1170|088|S|pharmacist.||
1170|089|S|   In the US -||
1170|090|S|   Call your doctor for medical advice about side effects. You||
1170|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1170|092|S|www.fda.gov/medwatch.||
1170|093|S|   In Canada - Call your doctor for medical advice about side||
1170|094|S|effects. You may report side effects to Health Canada at||
1170|095|S|1-866-234-2345.||
1170|096|B|||
1170|097|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1170|098|P|pharmacist if you are allergic to pramoxine; or to||
1170|099|P|hydrocortisone; or if you have any other allergies. This product||
1170|100|P|may contain inactive ingredients, which can cause allergic||
1170|101|P|reactions or other problems. Talk to your pharmacist for more||
1170|102|P|details.||
1170|103|P|   Before using this medication, tell your doctor or pharmacist||
1170|104|P|your medical history, especially of: diabetes, eye problems,||
1170|105|P|infections (especially rectal sores/infections), liver disease,||
1170|106|P|stomach/intestinal problems.||
1170|107|P|   Rarely, using corticosteroid medications for a long time can||
1170|108|P|make it more difficult for your body to respond to physical||
1170|109|P|stress. Before having surgery or emergency treatment, or if you||
1170|110|P|get a serious illness/injury, tell your doctor or dentist that||
1170|111|P|you are using this medication or have used this medication within||
1170|112|P|the past few months.||
1170|113|P|   Though it is unlikely, this medication may temporarily slow||
1170|114|P|down a child's growth if used for a long time. See the doctor||
1170|115|P|regularly so your child's height can be checked.||
1170|116|P|   During pregnancy, this medication should be used only when||
1170|117|P|clearly needed. It should not be used for long periods of time or||
1170|118|P|in large amounts. Discuss the risks and benefits with your||
1170|119|P|doctor.||
1170|120|P|   It is unknown if this medication passes into breast milk.||
1170|121|P|Consult your doctor before breastfeeding.||
1170|122|B|||
1170|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1170|124|I|medications work or increase your risk for serious side effects.||
1170|125|I|This document does not contain all possible drug interactions.||
1170|126|I|Keep a list of all the products you use (including||
1170|127|I|prescription/nonprescription drugs and herbal products) and share||
1170|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
1170|129|I|the dosage of any medicines without your doctor's approval.||
1170|130|I|   A product that may interact with this drug is: desmopressin.||
1170|131|B|||
1170|132|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1170|133|O|has overdosed and has serious symptoms such as passing out or||
1170|134|O|trouble breathing, call 911. Otherwise, call a poison control||
1170|135|O|center right away. US residents can call 1-800-222-1222. Canada||
1170|136|O|residents can call 1-844-764-7669.||
1170|137|B|||
1170|138|N|NOTES:  Lab and/or medical tests (such as cortisol levels) may be||
1170|139|N|done while you are using this medication. Keep all medical and||
1170|140|N|lab appointments. Consult your doctor for more details.||
1170|141|N|   This medication has been prescribed for your current condition||
1170|142|N|only. Do not use it later for another condition unless told to do||
1170|143|N|so by your doctor. A different medication may be necessary in||
1170|144|N|that case.||
1170|145|B|||
1170|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
1170|147|D|unless it is almost time for the next dose. In that case, skip||
1170|148|D|the missed dose. Use your next dose at the regular time. Do not||
1170|149|D|double the dose to catch up.||
1170|150|B|||
1170|151|R|STORAGE:  Store the foam canister upright at room temperature||
1170|152|R|away from heat. Do not refrigerate. The contents of this||
1170|153|R|container are under pressure. Do not burn or puncture the aerosol||
1170|154|R|container. Keep all medications away from children and pets.||
1170|155|R|   Do not flush medications down the toilet or pour them into a||
1170|156|R|drain unless instructed to do so. Properly discard this product||
1170|157|R|when it is expired or no longer needed. Consult your pharmacist||
1170|158|R|or local waste disposal company.||
1170|159|B|||
1170|160|A|Information last revised April 2025.||
1170|161|A|Copyright(c) 2025 First Databank, Inc.||
1170|162|B|||
1171|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1171|002|Z|does NOT have all possible information about this product. This||
1171|003|Z|information does not assure that this product is safe, effective,||
1171|004|Z|or appropriate for you. This information is not individual||
1171|005|Z|medical advice and does not substitute for the advice of your||
1171|006|Z|health care professional. Always ask your health care||
1171|007|Z|professional for complete information about this product and your||
1171|008|Z|specific health needs.||
1171|009|B|||
1171|010|T|CARBAMIDE PEROXIDE - OTIC||
1171|011|F|(KAR-buh-mide purr-OX-ide)||
1171|012|B|||
1171|013|C|COMMON BRAND NAME(S): Auro, Debrox||
1171|014|B|||
1171|015|U|USES:  This medication is used to treat earwax buildup. It helps||
1171|016|U|to soften, loosen, and remove the earwax. Too much earwax can||
1171|017|U|block the ear canal and reduce hearing. This medication releases||
1171|018|U|oxygen and starts to foam when it comes in contact with the skin.||
1171|019|U|The foaming helps break up and remove the earwax.||
1171|020|U|   Consult your doctor before using this product in children||
1171|021|U|younger than 12 years.||
1171|022|B|||
1171|023|H|HOW TO USE:  This medication is for use only in the ear. Apply||
1171|024|H|this medication into the ear, usually twice daily or as directed||
1171|025|H|by your doctor. Do not use this medication for more than 4 days||
1171|026|H|at a time unless your doctor instructs you to. Follow all||
1171|027|H|directions on the product package. If you have any questions, ask||
1171|028|H|your doctor or pharmacist.||
1171|029|H|   To make sure that the right amount of medication is given, and||
1171|030|H|to avoid touching the ear with the dropper, have another person||
1171|031|H|give the drops if possible. To lower the risk of dizziness, hold||
1171|032|H|the container in your hand for a few minutes to warm it.||
1171|033|H|   To apply ear drops, wash your hands first. To avoid||
1171|034|H|contamination, do not touch the dropper tip or let it touch your||
1171|035|H|ear or any other surface. Lie on your side or tilt the affected||
1171|036|H|ear upward. Hold the dropper directly over the ear and place 5 to||
1171|037|H|10 drops into the ear canal. To help the drops roll into the ear||
1171|038|H|of an adult, hold the earlobe up and back. In children, hold the||
1171|039|H|earlobe down and back. Keep the head tilted for several minutes||
1171|040|H|or insert a soft cotton plug in the ear.||
1171|041|H|   If there is any wax remaining after treatment, it may be||
1171|042|H|removed by gently rinsing the ear with warm water or using an ear||
1171|043|H|syringe with a soft rubber bulb. Consult your doctor or||
1171|044|H|pharmacist about using an ear syringe safely.||
1171|045|H|   Do not rinse the dropper. Replace the dropper cap after use.||
1171|046|H|   Avoid getting this medication in your eyes. If this occurs,||
1171|047|H|rinse the eyes thoroughly with water.||
1171|048|H|   If your condition lasts after 4 days of use or if it gets||
1171|049|H|worse, or if you think you may have a serious medical problem,||
1171|050|H|get medical help right away.||
1171|051|B|||
1171|052|S|SIDE EFFECTS:  Side effects usually do not occur with this||
1171|053|S|product.||
1171|054|S|   If your doctor has directed you to use this medication,||
1171|055|S|remember that your doctor has judged that the benefit to you is||
1171|056|S|greater than the risk of side effects. Many people using this||
1171|057|S|medication do not have serious side effects.||
1171|058|S|   A very serious allergic reaction to this drug is rare.||
1171|059|S|However, get medical help right away if you notice any symptoms||
1171|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1171|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1171|062|S|breathing.||
1171|063|S|   This is not a complete list of possible side effects. If you||
1171|064|S|notice other effects not listed above, contact your doctor or||
1171|065|S|pharmacist.||
1171|066|S|   In the US -||
1171|067|S|   Call your doctor for medical advice about side effects. You||
1171|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1171|069|S|www.fda.gov/medwatch.||
1171|070|S|   In Canada - Call your doctor for medical advice about side||
1171|071|S|effects. You may report side effects to Health Canada at||
1171|072|S|1-866-234-2345.||
1171|073|B|||
1171|074|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1171|075|P|pharmacist if you are allergic to it; or if you have any other||
1171|076|P|allergies. This product may contain inactive ingredients, which||
1171|077|P|can cause allergic reactions or other problems. Talk to your||
1171|078|P|pharmacist for more details.||
1171|079|P|   If you have any of the following health problems, consult your||
1171|080|P|doctor or pharmacist before using this product: other ear||
1171|081|P|problems (such as ear drainage, infection, pain, rash, injury,||
1171|082|P|recent ear surgery, hole/perforation in the eardrum), dizziness.||
1171|083|P|   Tell your doctor if you are pregnant or breastfeeding before||
1171|084|P|using this medication.||
1171|085|B|||
1171|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1171|087|I|medications work or increase your risk for serious side effects.||
1171|088|I|This document does not contain all possible drug interactions.||
1171|089|I|Keep a list of all the products you use (including||
1171|090|I|prescription/nonprescription drugs and herbal products) and share||
1171|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
1171|092|I|the dosage of any medicines without your doctor's approval.||
1171|093|B|||
1171|094|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1171|095|O|has overdosed and has serious symptoms such as passing out or||
1171|096|O|trouble breathing, call 911. Otherwise, call a poison control||
1171|097|O|center right away. US residents can call 1-800-222-1222. Canada||
1171|098|O|residents can call 1-844-764-7669.||
1171|099|B|||
1171|100|N|NOTES:  Do not share this medication with others.||
1171|101|B|||
1171|102|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1171|103|D|If it is near the time of the next dose, skip the missed dose.||
1171|104|D|Use your next dose at the regular time. Do not double the dose to||
1171|105|D|catch up.||
1171|106|B|||
1171|107|R|STORAGE:  Store at room temperature away from direct sunlight and||
1171|108|R|heat. Refer to storage information printed on the package. If you||
1171|109|R|have any questions about storage, ask your pharmacist. Keep all||
1171|110|R|medications away from children and pets.||
1171|111|R|   Do not flush medications down the toilet or pour them into a||
1171|112|R|drain unless instructed to do so. Properly discard this product||
1171|113|R|when it is expired or no longer needed. Consult your pharmacist||
1171|114|R|or local waste disposal company.||
1171|115|B|||
1171|116|A|Information last revised May 2024.||
1171|117|A|Copyright(c) 2025 First Databank, Inc.||
1171|118|B|||
1173|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1173|002|Z|does NOT have all possible information about this product. This||
1173|003|Z|information does not assure that this product is safe, effective,||
1173|004|Z|or appropriate for you. This information is not individual||
1173|005|Z|medical advice and does not substitute for the advice of your||
1173|006|Z|health care professional. Always ask your health care||
1173|007|Z|professional for complete information about this product and your||
1173|008|Z|specific health needs.||
1173|009|B|||
1173|010|T|OMEPRAZOLE DELAYED-RELEASE PACKET - ORAL||
1173|011|F|(oh-MEH-pruh-zole)||
1173|012|B|||
1173|013|C|COMMON BRAND NAME(S): Prilosec||
1173|014|B|||
1173|015|U|USES:  Omeprazole is used to treat certain stomach and esophagus||
1173|016|U|problems (such as acid reflux, ulcers). It works by decreasing||
1173|017|U|the amount of acid your stomach makes. It relieves symptoms such||
1173|018|U|as heartburn, difficulty swallowing, and cough. This medication||
1173|019|U|helps heal acid damage to the stomach and esophagus, helps||
1173|020|U|prevent ulcers, and may help prevent cancer of the esophagus.||
1173|021|U|Omeprazole belongs to a class of drugs known as proton pump||
1173|022|U|inhibitors (PPIs).||
1173|023|B|||
1173|024|H|HOW TO USE:  Read the Medication Guide provided by your||
1173|025|H|pharmacist before you start taking omeprazole and each time you||
1173|026|H|get a refill. If you have any questions, ask your doctor or||
1173|027|H|pharmacist.||
1173|028|H|   Take this medication by mouth before a meal as directed by||
1173|029|H|your doctor, usually once daily. This medication may also be||
1173|030|H|given through a tube into the stomach (nasogastric or gastric||
1173|031|H|tube). The dosage and length of treatment are based on your||
1173|032|H|medical condition and response to treatment. Children's dosage is||
1173|033|H|also based on weight.||
1173|034|H|   If you are taking this medication by mouth, empty the contents||
1173|035|H|of a packet into a container with 1 to 3 teaspoons (5 to 15||
1173|036|H|milliliters) of water. Check the manufacturer package directions||
1173|037|H|for the proper amount of water to use for your dose. Stir the||
1173|038|H|mixture well and leave it for 2 to 3 minutes to thicken. Stir||
1173|039|H|again and drink all of the mixture within 30 minutes. If any||
1173|040|H|medication remains in the container, add more water, stir, and||
1173|041|H|drink right away to make sure you take the entire dose. Do not||
1173|042|H|crush or chew the medication granules. Doing so may destroy the||
1173|043|H|drug.||
1173|044|H|   If you are giving this medication through a nasogastric or||
1173|045|H|gastric tube, ask your health care professional for detailed||
1173|046|H|instructions on how to properly mix and give it.||
1173|047|H|   If needed, antacids may be taken along with this medication.||
1173|048|H|If you are also taking sucralfate, take omeprazole at least 30||
1173|049|H|minutes before sucralfate.||
1173|050|H|   Use this medication regularly to get the most benefit from it.||
1173|051|H|To help you remember, take it at the same time each day. Continue||
1173|052|H|to take this medication for the prescribed length of treatment||
1173|053|H|even if you are feeling better.||
1173|054|H|   Tell your doctor if your condition lasts or gets worse. The||
1173|055|H|risk of side effects goes up over time. Ask your doctor how long||
1173|056|H|you should take this medication.||
1173|057|B|||
1173|058|S|SIDE EFFECTS:  See also Precautions section.||
1173|059|S|   Headache or abdominal pain may occur. If any of these effects||
1173|060|S|last or get worse, tell your doctor or pharmacist promptly.||
1173|061|S|   Remember that this medication has been prescribed because your||
1173|062|S|doctor has judged that the benefit to you is greater than the||
1173|063|S|risk of side effects. Many people using this medication do not||
1173|064|S|have serious side effects.||
1173|065|S|   Tell your doctor right away if you have any serious side||
1173|066|S|effects, including: symptoms of a low magnesium blood level (such||
1173|067|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
1173|068|S|(such as rash on nose and cheeks, new or worsening joint pain),||
1173|069|S|signs of kidney problems (such as change in the amount of urine,||
1173|070|S|pink/bloody urine).||
1173|071|S|   This medication may rarely cause a severe intestinal condition||
1173|072|S|due to a bacteria called C. difficile. This condition may occur||
1173|073|S|during treatment or weeks to months after treatment has stopped.||
1173|074|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1173|075|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1173|076|S|stool.||
1173|077|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1173|078|S|products because they may make symptoms worse.||
1173|079|S|   Rarely, proton pump inhibitors (such as omeprazole) have||
1173|080|S|caused vitamin B-12 deficiency. The risk is increased if they are||
1173|081|S|taken every day for a long time (3 years or longer). Tell your||
1173|082|S|doctor right away if you develop symptoms of vitamin B-12||
1173|083|S|deficiency (such as unusual weakness, sore tongue, or||
1173|084|S|numbness/tingling of the hands/feet).||
1173|085|S|   A very serious allergic reaction to this drug is rare.||
1173|086|S|However, get medical help right away if you notice any symptoms||
1173|087|S|of a serious allergic reaction, including: fever, swollen lymph||
1173|088|S|nodes, rash, itching/swelling (especially of the||
1173|089|S|face/tongue/throat), severe dizziness, trouble breathing.||
1173|090|S|   This is not a complete list of possible side effects. If you||
1173|091|S|notice other effects not listed above, contact your doctor or||
1173|092|S|pharmacist.||
1173|093|S|   In the US -||
1173|094|S|   Call your doctor for medical advice about side effects. You||
1173|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1173|096|S|www.fda.gov/medwatch.||
1173|097|S|   In Canada - Call your doctor for medical advice about side||
1173|098|S|effects. You may report side effects to Health Canada at||
1173|099|S|1-866-234-2345.||
1173|100|B|||
1173|101|P|PRECAUTIONS:  Before taking omeprazole, tell your doctor or||
1173|102|P|pharmacist if you are allergic to it; or to similar drugs (such||
1173|103|P|as esomeprazole, lansoprazole, pantoprazole); or if you have any||
1173|104|P|other allergies. This product may contain inactive ingredients,||
1173|105|P|which can cause allergic reactions or other problems. Talk to||
1173|106|P|your pharmacist for more details.||
1173|107|P|   Before using this medication, tell your doctor or pharmacist||
1173|108|P|your medical history, especially of: liver disease, lupus.||
1173|109|P|   Some symptoms may actually be signs of a more serious||
1173|110|P|condition. Get medical help right away if you have: heartburn||
1173|111|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
1173|112|P|pain (especially with shortness of breath, unusual sweating),||
1173|113|P|unexplained weight loss.||
1173|114|P|   Before having surgery, tell your doctor or dentist about all||
1173|115|P|the products you use (including prescription drugs,||
1173|116|P|nonprescription drugs, and herbal products).||
1173|117|P|   Proton pump inhibitors (such as omeprazole) may increase your||
1173|118|P|risk for bone fractures, especially with longer use, higher||
1173|119|P|doses, and in older adults. Talk with your doctor or pharmacist||
1173|120|P|about ways to prevent bone loss/fracture, such as by taking||
1173|121|P|calcium (such as calcium citrate) and vitamin D supplements.||
1173|122|P|   Older adults may be more sensitive to the side effects of this||
1173|123|P|drug, especially bone loss and fractures (see above), and C.||
1173|124|P|difficile infection (see Side Effects section).||
1173|125|P|   Children may be more sensitive to the side effects of this||
1173|126|P|drug, especially fever, cough, and infections of the||
1173|127|P|nose/throat/airways.||
1173|128|P|   During pregnancy, this medication should be used only when||
1173|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
1173|130|P|   This medication passes into breast milk. The effects on a||
1173|131|P|nursing infant are unknown. Consult your doctor before||
1173|132|P|breastfeeding.||
1173|133|B|||
1173|134|I|DRUG INTERACTIONS:  See also How to Use section.||
1173|135|I|   Drug interactions may change how your medications work or||
1173|136|I|increase your risk for serious side effects. This document does||
1173|137|I|not contain all possible drug interactions. Keep a list of all||
1173|138|I|the products you use (including prescription/nonprescription||
1173|139|I|drugs and herbal products) and share it with your doctor and||
1173|140|I|pharmacist. Do not start, stop, or change the dosage of any||
1173|141|I|medicines without your doctor's approval.||
1173|142|I|   Some products that may interact with this drug include:||
1173|143|I|clopidogrel, methotrexate (especially high-dose treatment),||
1173|144|I|rifampin, St John's wort.||
1173|145|I|   Some products need stomach acid so that the body can absorb||
1173|146|I|them properly. Omeprazole decreases stomach acid, so it may||
1173|147|I|change how well these products work. Some affected products||
1173|148|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
1173|149|I|pazopanib, rilpivirine, sparsentan, certain azole antifungals||
1173|150|I|(itraconazole, ketoconazole, posaconazole), among others.||
1173|151|I|   Omeprazole is very similar to esomeprazole. Do not use any||
1173|152|I|medications containing esomeprazole while using omeprazole.||
1173|153|I|   This medication may interfere with certain lab tests, possibly||
1173|154|I|causing false test results. Make sure lab personnel and all your||
1173|155|I|doctors know you use this drug.||
1173|156|B|||
1173|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1173|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1173|159|O|poison control center right away. US residents can call||
1173|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1173|161|O|Symptoms of overdose may include: confusion, unusual sweating,||
1173|162|O|blurred vision, unusually fast heartbeat.||
1173|163|B|||
1173|164|N|NOTES:  Do not share this medication with others.||
1173|165|N|   If your doctor instructs you to use this medication regularly||
1173|166|N|for a long time, lab and/or medical tests (such as a magnesium||
1173|167|N|blood test, vitamin B-12 levels) may be done while you are taking||
1173|168|N|this medication. Keep all medical and lab appointments. Consult||
1173|169|N|your doctor for more details.||
1173|170|B|||
1173|171|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1173|172|D|remember. If it is near the time of the next dose, skip the||
1173|173|D|missed dose. Take your next dose at the regular time. Do not||
1173|174|D|double the dose to catch up.||
1173|175|B|||
1173|176|R|STORAGE:  Store at room temperature away from moisture. Do not||
1173|177|R|open the packets until you are ready to use the medication. Do||
1173|178|R|not store in the bathroom. Keep all medications away from||
1173|179|R|children and pets.||
1173|180|R|   Do not flush medications down the toilet or pour them into a||
1173|181|R|drain unless instructed to do so. Properly discard this product||
1173|182|R|when it is expired or no longer needed. Consult your pharmacist||
1173|183|R|or local waste disposal company.||
1173|184|B|||
1173|185|A|Information last revised April 2025.||
1173|186|A|Copyright(c) 2025 First Databank, Inc.||
1173|187|B|||
1175|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1175|002|Z|does NOT have all possible information about this product. This||
1175|003|Z|information does not assure that this product is safe, effective,||
1175|004|Z|or appropriate for you. This information is not individual||
1175|005|Z|medical advice and does not substitute for the advice of your||
1175|006|Z|health care professional. Always ask your health care||
1175|007|Z|professional for complete information about this product and your||
1175|008|Z|specific health needs.||
1175|009|B|||
1175|010|T|DEXLANSOPRAZOLE - ORAL||
1175|011|F|(DEX-lan-SOE-pra-zole)||
1175|012|B|||
1175|013|C|COMMON BRAND NAME(S): Dexilant||
1175|014|B|||
1175|015|U|USES:  Dexlansoprazole is used to treat certain stomach and||
1175|016|U|esophagus problems (such as acid reflux). It works by decreasing||
1175|017|U|the amount of acid your stomach makes. It relieves symptoms such||
1175|018|U|as heartburn, difficulty swallowing, and cough. This medication||
1175|019|U|helps heal acid damage to the stomach and esophagus, helps||
1175|020|U|prevent ulcers, and may help prevent cancer of the esophagus.||
1175|021|U|Dexlansoprazole belongs to a class of drugs known as proton pump||
1175|022|U|inhibitors (PPIs).||
1175|023|U|   Dexlansoprazole is not recommended for use in children younger||
1175|024|U|than 2 years due to an increased risk of serious side effects.||
1175|025|U|Ask the doctor or pharmacist for details.||
1175|026|B|||
1175|027|V|OTHER USES:  This section contains uses of this drug that are not||
1175|028|V|listed in the approved professional labeling for the drug but||
1175|029|V|that may be prescribed by your health care professional. Use this||
1175|030|V|drug for a condition that is listed in this section only if it||
1175|031|V|has been so prescribed by your health care professional.||
1175|032|V|   This drug may also be used for stomach ulcers.||
1175|033|B|||
1175|034|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1175|035|H|Patient Information Leaflet provided by your pharmacist before||
1175|036|H|you start taking dexlansoprazole and each time you get a refill.||
1175|037|H|If you have any questions, ask your doctor or pharmacist.||
1175|038|H|   Take this medication by mouth with or without food as directed||
1175|039|H|by your doctor, usually once daily. If your symptoms usually||
1175|040|H|occur after a meal, your doctor may direct you to take your dose||
1175|041|H|every day before the same meal for best results. The dosage and||
1175|042|H|length of treatment are based on your medical condition and||
1175|043|H|response to treatment.||
1175|044|H|   Do not crush or chew the capsules. Swallow this medication||
1175|045|H|whole. If you have trouble swallowing this medication whole, you||
1175|046|H|may open the capsule and sprinkle the contents onto 1 tablespoon||
1175|047|H|(15 milliliters) of applesauce. Swallow all of the drug/food||
1175|048|H|mixture right away without chewing it. Do not prepare the mixture||
1175|049|H|ahead of time for later use. Doing so may destroy the drug.||
1175|050|H|   If you are giving this drug with a liquid medication measuring||
1175|051|H|device/syringe, or through a tube into the stomach (nasogastric||
1175|052|H|or gastric tube), ask your health care professional for detailed||
1175|053|H|instructions on how to properly mix and give it.||
1175|054|H|   If needed, antacids may be taken along with this medication.||
1175|055|H|If you are also taking sucralfate, take dexlansoprazole at least||
1175|056|H|30 minutes before sucralfate.||
1175|057|H|   Use this medication regularly to get the most benefit from it.||
1175|058|H|To help you remember, take it at the same time each day. Continue||
1175|059|H|to take this medication for the prescribed length of treatment||
1175|060|H|even if you are feeling better.||
1175|061|H|   Tell your doctor if your condition lasts or gets worse. The||
1175|062|H|risk of side effects goes up over time. Ask your doctor how long||
1175|063|H|you should take this medication.||
1175|064|B|||
1175|065|S|SIDE EFFECTS:  Diarrhea may occur. If this effect lasts or gets||
1175|066|S|worse, tell your doctor or pharmacist promptly.||
1175|067|S|   Remember that this medication has been prescribed because your||
1175|068|S|doctor has judged that the benefit to you is greater than the||
1175|069|S|risk of side effects. Many people using this medication do not||
1175|070|S|have serious side effects.||
1175|071|S|   Tell your doctor right away if you have any serious side||
1175|072|S|effects, including: symptoms of a low magnesium blood level (such||
1175|073|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
1175|074|S|(such as rash on nose and cheeks, new or worsening joint pain),||
1175|075|S|signs of kidney problems (such as change in the amount of urine,||
1175|076|S|pink/bloody urine).||
1175|077|S|   This medication may rarely cause a severe intestinal condition||
1175|078|S|due to a bacteria called C. difficile. This condition may occur||
1175|079|S|during treatment or weeks to months after treatment has stopped.||
1175|080|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1175|081|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1175|082|S|stool.||
1175|083|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1175|084|S|products because they may make symptoms worse.||
1175|085|S|   Rarely, proton pump inhibitors (such as dexlansoprazole) have||
1175|086|S|caused vitamin B-12 deficiency. The risk is increased if they are||
1175|087|S|taken every day for a long time (3 years or longer). Tell your||
1175|088|S|doctor right away if you develop symptoms of vitamin B-12||
1175|089|S|deficiency (such as unusual weakness, sore tongue, or||
1175|090|S|numbness/tingling of the hands/feet).||
1175|091|S|   A very serious allergic reaction to this drug is rare.||
1175|092|S|However, get medical help right away if you notice any symptoms||
1175|093|S|of a serious allergic reaction, including: fever, swollen lymph||
1175|094|S|nodes, rash, itching/swelling (especially of the||
1175|095|S|face/tongue/throat), severe dizziness, trouble breathing.||
1175|096|S|   This is not a complete list of possible side effects. If you||
1175|097|S|notice other effects not listed above, contact your doctor or||
1175|098|S|pharmacist.||
1175|099|S|   In the US -||
1175|100|S|   Call your doctor for medical advice about side effects. You||
1175|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1175|102|S|www.fda.gov/medwatch.||
1175|103|S|   In Canada - Call your doctor for medical advice about side||
1175|104|S|effects. You may report side effects to Health Canada at||
1175|105|S|1-866-234-2345.||
1175|106|B|||
1175|107|P|PRECAUTIONS:  Before taking dexlansoprazole, tell your doctor or||
1175|108|P|pharmacist if you are allergic to it; or to similar drugs (such||
1175|109|P|as lansoprazole, omeprazole); or if you have any other allergies.||
1175|110|P|This product may contain inactive ingredients, which can cause||
1175|111|P|allergic reactions or other problems. Talk to your pharmacist for||
1175|112|P|more details.||
1175|113|P|   Before using this medication, tell your doctor or pharmacist||
1175|114|P|your medical history, especially of: liver disease, lupus.||
1175|115|P|   Some symptoms may actually be signs of a more serious||
1175|116|P|condition. Get medical help right away if you have: heartburn||
1175|117|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
1175|118|P|pain (especially with shortness of breath, unusual sweating),||
1175|119|P|unexplained weight loss.||
1175|120|P|   Before having surgery, tell your doctor or dentist about all||
1175|121|P|the products you use (including prescription drugs,||
1175|122|P|nonprescription drugs, and herbal products).||
1175|123|P|   Proton pump inhibitors (such as dexlansoprazole) may increase||
1175|124|P|your risk for bone fractures, especially with longer use, higher||
1175|125|P|doses, and in older adults. Talk with your doctor or pharmacist||
1175|126|P|about ways to prevent bone loss/fracture, such as by taking||
1175|127|P|calcium (such as calcium citrate) and vitamin D supplements.||
1175|128|P|   Older adults may be more sensitive to the side effects of this||
1175|129|P|drug, especially bone loss and fractures (see above), and C.||
1175|130|P|difficile infection (see Side Effects section).||
1175|131|P|   During pregnancy, this medication should be used only when||
1175|132|P|clearly needed. Discuss the risks and benefits with your doctor.||
1175|133|P|   It is unknown if this drug passes into breast milk. However,||
1175|134|P|similar drugs pass into breast milk. The effects on a nursing||
1175|135|P|infant are unknown. Consult your doctor before breastfeeding.||
1175|136|B|||
1175|137|I|DRUG INTERACTIONS:  See also How to Use section.||
1175|138|I|   Drug interactions may change how your medications work or||
1175|139|I|increase your risk for serious side effects. This document does||
1175|140|I|not contain all possible drug interactions. Keep a list of all||
1175|141|I|the products you use (including prescription/nonprescription||
1175|142|I|drugs and herbal products) and share it with your doctor and||
1175|143|I|pharmacist. Do not start, stop, or change the dosage of any||
1175|144|I|medicines without your doctor's approval.||
1175|145|I|   A product that may interact with this drug is: methotrexate||
1175|146|I|(especially high-dose treatment).||
1175|147|I|   Some products need stomach acid so that the body can absorb||
1175|148|I|them properly. Dexlansoprazole decreases stomach acid, so it may||
1175|149|I|change how well these products work. Some affected products||
1175|150|I|include ampicillin, atazanavir, erlotinib, levoketoconazole,||
1175|151|I|nelfinavir, pazopanib, rilpivirine, sparsentan, certain azole||
1175|152|I|antifungals (itraconazole, ketoconazole, posaconazole), among||
1175|153|I|others.||
1175|154|I|   Dexlansoprazole is very similar to lansoprazole. Do not use||
1175|155|I|medications containing lansoprazole while using dexlansoprazole.||
1175|156|I|   This medication may interfere with certain lab tests, possibly||
1175|157|I|causing false test results. Make sure lab personnel and all your||
1175|158|I|doctors know you use this drug.||
1175|159|B|||
1175|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1175|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1175|162|O|poison control center right away. US residents can call||
1175|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1175|164|B|||
1175|165|N|NOTES:  Do not share this medication with others.||
1175|166|N|   If your doctor instructs you to use this medication regularly||
1175|167|N|for a long time, lab and/or medical tests (such as a magnesium||
1175|168|N|blood test, vitamin B-12 levels) may be done while you are taking||
1175|169|N|this medication. Keep all medical and lab appointments. Consult||
1175|170|N|your doctor for more details.||
1175|171|B|||
1175|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1175|173|D|remember. If it is near the time of the next dose, skip the||
1175|174|D|missed dose. Take your next dose at the regular time. Do not||
1175|175|D|double the dose to catch up.||
1175|176|B|||
1175|177|R|STORAGE:  Store at room temperature away from light and moisture.||
1175|178|R|Do not store in the bathroom. Keep all medications away from||
1175|179|R|children and pets.||
1175|180|R|   Do not flush medications down the toilet or pour them into a||
1175|181|R|drain unless instructed to do so. Properly discard this product||
1175|182|R|when it is expired or no longer needed. Consult your pharmacist||
1175|183|R|or local waste disposal company.||
1175|184|B|||
1175|185|A|Information last revised June 2024.||
1175|186|A|Copyright(c) 2025 First Databank, Inc.||
1175|187|B|||
1176|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1176|002|Z|does NOT have all possible information about this product. This||
1176|003|Z|information does not assure that this product is safe, effective,||
1176|004|Z|or appropriate for you. This information is not individual||
1176|005|Z|medical advice and does not substitute for the advice of your||
1176|006|Z|health care professional. Always ask your health care||
1176|007|Z|professional for complete information about this product and your||
1176|008|Z|specific health needs.||
1176|009|B|||
1176|010|T|CALCITRIOL OINTMENT - TOPICAL||
1176|011|F|(KAL-si-TRYE-ol)||
1176|012|B|||
1176|013|C|COMMON BRAND NAME(S): Vectical||
1176|014|B|||
1176|015|U|USES:  This medication is used to treat psoriasis. Calcitriol is||
1176|016|U|a form of vitamin D. It works by slowing down the growth of||
1176|017|U|cells.||
1176|018|B|||
1176|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1176|020|H|from your pharmacist before you start using calcitriol and each||
1176|021|H|time you get a refill. If you have any questions, ask your doctor||
1176|022|H|or pharmacist.||
1176|023|H|   Use this medication on the skin only. Wash the affected area||
1176|024|H|and pat dry. Apply a thin layer of medication as directed by your||
1176|025|H|doctor, usually twice daily (once in the morning and once in the||
1176|026|H|evening). Apply only to the areas of skin affected by psoriasis.||
1176|027|H|Gently rub in. Wash your hands after using, unless you are using||
1176|028|H|this medication to treat the hands. Do not apply calcitriol to||
1176|029|H|the face, in the eyes, nose, or mouth, or inside the vagina. If||
1176|030|H|you do get the medication in those areas, flush with plenty of||
1176|031|H|water.||
1176|032|H|   Do not apply to a larger area of skin, apply more often, or||
1176|033|H|use longer than prescribed. Your skin will not improve any faster||
1176|034|H|and this may increase the risk of side effects. Discuss with your||
1176|035|H|doctor the maximum amount of medication you may use per day (or||
1176|036|H|per week). Do not cover, bandage, or wrap the area unless||
1176|037|H|directed to do so by your doctor. Do not apply to more than||
1176|038|H|one-third of your body.||
1176|039|H|   Use this medication regularly to get the most benefit from it.||
1176|040|H|To help you remember, use it at the same times each day.||
1176|041|H|   Tell your doctor if your condition does not get better or if||
1176|042|H|it gets worse. You should usually begin to see an improvement in||
1176|043|H|your skin condition after 4 weeks of treatment.||
1176|044|B|||
1176|045|S|SIDE EFFECTS:  Pain, burning, itching, redness, or peeling at the||
1176|046|S|application site may occur. If any of these effects last or get||
1176|047|S|worse, notify your doctor or pharmacist promptly.||
1176|048|S|   Remember that this medication has been prescribed because your||
1176|049|S|doctor has judged that the benefit to you is greater than the||
1176|050|S|risk of side effects. Many people using this medication do not||
1176|051|S|have serious side effects.||
1176|052|S|   This medication may rarely increase calcium in your blood.||
1176|053|S|Tell your doctor right away if any of these symptoms of high||
1176|054|S|calcium occur: unusual tiredness, mental/mood changes,||
1176|055|S|unexplained constipation, pink/bloody urine, painful urination.||
1176|056|S|   A very serious allergic reaction to this drug is rare.||
1176|057|S|However, get medical help right away if you notice any symptoms||
1176|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1176|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1176|060|S|breathing.||
1176|061|S|   This is not a complete list of possible side effects. If you||
1176|062|S|notice other effects not listed above, contact your doctor or||
1176|063|S|pharmacist.||
1176|064|S|   In the US -||
1176|065|S|   Call your doctor for medical advice about side effects. You||
1176|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1176|067|S|www.fda.gov/medwatch.||
1176|068|S|   In Canada - Call your doctor for medical advice about side||
1176|069|S|effects. You may report side effects to Health Canada at||
1176|070|S|1-866-234-2345.||
1176|071|B|||
1176|072|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1176|073|P|pharmacist if you are allergic to it; or to other vitamin D||
1176|074|P|products; or if you have any other allergies. This product may||
1176|075|P|contain inactive ingredients, which can cause allergic reactions||
1176|076|P|or other problems. Talk to your pharmacist for more details.||
1176|077|P|   Before using this medication, tell your doctor or pharmacist||
1176|078|P|your medical history, especially of: high calcium/vitamin D||
1176|079|P|levels (hypercalcemia/hypervitaminosis D), kidney disease, liver||
1176|080|P|disease.||
1176|081|P|   This medication may make you more sensitive to the sun. Limit||
1176|082|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1176|083|P|sunscreen and wear protective clothing when outdoors. Tell your||
1176|084|P|doctor right away if you get sunburned or have skin||
1176|085|P|blisters/redness. Your doctor may direct you to limit or avoid||
1176|086|P|phototherapy while you use this product. Ask your doctor for||
1176|087|P|details.||
1176|088|P|   During pregnancy, this medication should be used only when||
1176|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
1176|090|P|   It is unknown if this drug passes into breast milk. Consult||
1176|091|P|your doctor before breastfeeding.||
1176|092|B|||
1176|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1176|094|I|medications work or increase your risk for serious side effects.||
1176|095|I|This document does not contain all possible drug interactions.||
1176|096|I|Keep a list of all the products you use (including||
1176|097|I|prescription/nonprescription drugs and herbal products) and share||
1176|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
1176|099|I|the dosage of any medicines without your doctor's approval.||
1176|100|I|   Some products that may interact with this drug include: other||
1176|101|I|products containing vitamin D, drugs that can increase calcium||
1176|102|I|levels (such as thiazide "water pills", calcium supplements).||
1176|103|I|   Calcitriol ointment may be irritating to the skin. Ask your||
1176|104|I|doctor or pharmacist about the safe use of other skin products||
1176|105|I|that may have a drying effect (such as astringents, peeling||
1176|106|I|agents).||
1176|107|B|||
1176|108|O|OVERDOSE:  This medication may be harmful if applied to large||
1176|109|O|areas or swallowed. If someone has overdosed and has serious||
1176|110|O|symptoms such as passing out or trouble breathing, call 911.||
1176|111|O|Otherwise, call a poison control center right away. US residents||
1176|112|O|can call 1-800-222-1222. Canada residents can call||
1176|113|O|1-844-764-7669. Symptoms of overdose may include: nausea,||
1176|114|O|vomiting, loss of appetite, muscle weakness, depression.||
1176|115|B|||
1176|116|N|NOTES:  Do not share this medication with others.||
1176|117|N|   Lab and/or medical tests (such as calcium levels) may be done||
1176|118|N|while you are using this medication. Keep all medical and lab||
1176|119|N|appointments. Consult your doctor for more details.||
1176|120|N|   This medication has been prescribed for your current condition||
1176|121|N|only. Do not use it later for another skin condition unless told||
1176|122|N|to do so by your doctor. A different medication may be necessary||
1176|123|N|in that case.||
1176|124|B|||
1176|125|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1176|126|D|If it is near the time of the next dose, skip the missed dose.||
1176|127|D|Use your next dose at the regular time. Do not double the dose to||
1176|128|D|catch up.||
1176|129|B|||
1176|130|R|STORAGE:  Store at room temperature. Do not freeze or||
1176|131|R|refrigerate. Keep all medications away from children and pets.||
1176|132|R|   Do not flush medications down the toilet or pour them into a||
1176|133|R|drain unless instructed to do so. Properly discard this product||
1176|134|R|when it is expired or no longer needed. Consult your pharmacist||
1176|135|R|or local waste disposal company.||
1176|136|B|||
1176|137|A|Information last revised November 2024.||
1176|138|A|Copyright(c) 2025 First Databank, Inc.||
1176|139|B|||
1177|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1177|002|Z|does NOT have all possible information about this product. This||
1177|003|Z|information does not assure that this product is safe, effective,||
1177|004|Z|or appropriate for you. This information is not individual||
1177|005|Z|medical advice and does not substitute for the advice of your||
1177|006|Z|health care professional. Always ask your health care||
1177|007|Z|professional for complete information about this product and your||
1177|008|Z|specific health needs.||
1177|009|B|||
1177|010|T|FEBUXOSTAT - ORAL||
1177|011|F|(feb-UX-oh-stat)||
1177|012|B|||
1177|013|C|COMMON BRAND NAME(S): Uloric||
1177|014|B|||
1177|015|W|WARNING:  Febuxostat may rarely cause very serious side effects||
1177|016|W|including heart attack, stroke, or possibly fatal heart-related||
1177|017|W|problems. Before taking this medication, tell your doctor if you||
1177|018|W|have heart disease, chest pain (angina), or have had a heart||
1177|019|W|attack or stroke in the past since these conditions may increase||
1177|020|W|your risk. Discuss the risks and benefits of this medication and||
1177|021|W|treatment options with your doctor. Get medical help right away||
1177|022|W|if you have any of these very serious side effects:||
1177|023|W|chest/jaw/left arm pain, unusual sweating, shortness of breath,||
1177|024|W|fast/irregular heartbeat, dizziness, fainting, weakness on one||
1177|025|W|side of the body, sudden vision changes, confusion, trouble||
1177|026|W|speaking, sudden severe headache.||
1177|027|B|||
1177|028|U|USES:  Febuxostat is used to lower uric acid levels in people||
1177|029|U|with gout. Febuxostat works by reducing the amount of uric acid||
1177|030|U|made by the body. An increased uric acid level can cause gout.||
1177|031|U|   Because of the risk of very serious heart-related problems and||
1177|032|U|stroke with febuxostat (see also Warning section), febuxostat||
1177|033|U|should be used only after treatment with a medication called||
1177|034|U|allopurinol did not work to lower your uric acid level, caused||
1177|035|U|serious side effects, or is not recommended by your doctor.||
1177|036|U|Febuxostat should be used only if you have symptoms caused by a||
1177|037|U|high blood uric acid level.||
1177|038|B|||
1177|039|H|HOW TO USE:  Read the Medication Guide provided by your||
1177|040|H|pharmacist before you start taking febuxostat and each time you||
1177|041|H|get a refill. If you have any questions, ask your doctor or||
1177|042|H|pharmacist.||
1177|043|H|   Take this medication by mouth with or without food as directed||
1177|044|H|by your doctor, usually once daily.||
1177|045|H|   The dosage is based on your medical condition and response to||
1177|046|H|treatment. Use this medication regularly to get the most benefit||
1177|047|H|from it. To help you remember, take it at the same time each day.||
1177|048|H|   You may have more gout attacks for several months after||
1177|049|H|starting this medicine while the body removes extra uric acid.||
1177|050|H|Febuxostat is not a pain reliever. Your doctor may prescribe||
1177|051|H|medication (such as colchicine, NSAIDs such as ibuprofen,||
1177|052|H|naproxen, or indomethacin) to prevent/treat a gout attack during||
1177|053|H|the first several months you are taking febuxostat. Continue to||
1177|054|H|take your prescribed medicines for gout attacks as directed by||
1177|055|H|your doctor.||
1177|056|H|   Tell your doctor if your condition lasts or gets worse.||
1177|057|B|||
1177|058|S|SIDE EFFECTS:  See also Warning section.||
1177|059|S|   Nausea may occur. If this effect lasts or gets worse, tell||
1177|060|S|your doctor or pharmacist promptly.||
1177|061|S|   Remember that this medication has been prescribed because your||
1177|062|S|doctor has judged that the benefit to you is greater than the||
1177|063|S|risk of side effects. Many people using this medication do not||
1177|064|S|have serious side effects.||
1177|065|S|   Febuxostat may rarely cause serious (possibly fatal) liver||
1177|066|S|disease. Tell your doctor right away if you develop symptoms of||
1177|067|S|liver disease, including nausea that doesn't stop,||
1177|068|S|stomach/abdominal pain, dark urine, yellowing eyes/skin.||
1177|069|S|   Tell your doctor right away if you have any serious side||
1177|070|S|effects, including: pink/bloody urine, painful urination.||
1177|071|S|   Febuxostat may cause a rash that could be a sign of a severe||
1177|072|S|reaction. Get medical help right away if you develop any rash.||
1177|073|S|   A very serious allergic reaction to this drug is rare.||
1177|074|S|However, get medical help right away if you notice any symptoms||
1177|075|S|of a serious allergic reaction, including: fever, swollen lymph||
1177|076|S|nodes, rash, itching/swelling (especially of the||
1177|077|S|face/tongue/throat), severe dizziness, trouble breathing.||
1177|078|S|   This is not a complete list of possible side effects. If you||
1177|079|S|notice other effects not listed above, contact your doctor or||
1177|080|S|pharmacist.||
1177|081|S|   In the US -||
1177|082|S|   Call your doctor for medical advice about side effects. You||
1177|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1177|084|S|www.fda.gov/medwatch.||
1177|085|S|   In Canada - Call your doctor for medical advice about side||
1177|086|S|effects. You may report side effects to Health Canada at||
1177|087|S|1-866-234-2345.||
1177|088|B|||
1177|089|P|PRECAUTIONS:  See also Warning section.||
1177|090|P|   Before taking febuxostat, tell your doctor or pharmacist if||
1177|091|P|you are allergic to it; or if you have any other allergies. This||
1177|092|P|product may contain inactive ingredients, which can cause||
1177|093|P|allergic reactions or other problems. Talk to your pharmacist for||
1177|094|P|more details.||
1177|095|P|   Before using this medication, tell your doctor or pharmacist||
1177|096|P|your medical history, especially of: cancer, heart disease (such||
1177|097|P|as heart attack, chest pain/angina), stroke, liver disease,||
1177|098|P|kidney disease, organ transplant.||
1177|099|P|   Before having surgery, tell your doctor or dentist about all||
1177|100|P|the products you use (including prescription drugs,||
1177|101|P|nonprescription drugs, and herbal products).||
1177|102|P|   During pregnancy, this medication should be used only when||
1177|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
1177|104|P|   It is unknown if febuxostat passes into breast milk. Consult||
1177|105|P|your doctor before breastfeeding.||
1177|106|B|||
1177|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1177|108|I|medications work or increase your risk for serious side effects.||
1177|109|I|This document does not contain all possible drug interactions.||
1177|110|I|Keep a list of all the products you use (including||
1177|111|I|prescription/nonprescription drugs and herbal products) and share||
1177|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
1177|113|I|the dosage of any medicines without your doctor's approval.||
1177|114|I|   Some products that may interact with this drug include:||
1177|115|I|azathioprine, mercaptopurine.||
1177|116|B|||
1177|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1177|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1177|119|O|poison control center right away. US residents can call||
1177|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1177|121|B|||
1177|122|N|NOTES:  Do not share this medication with others.||
1177|123|N|   Lab and/or medical tests (such as uric acid blood level, liver||
1177|124|N|function) should be done before you start taking this medication||
1177|125|N|and while you are taking it. Keep all medical and lab||
1177|126|N|appointments. Consult your doctor for more details.||
1177|127|B|||
1177|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1177|129|D|remember. If it is near the time of the next dose, skip the||
1177|130|D|missed dose. Take your next dose at the regular time. Do not||
1177|131|D|double the dose to catch up.||
1177|132|B|||
1177|133|R|STORAGE:  Store at room temperature away from light and moisture.||
1177|134|R|Do not store in the bathroom. Keep all medications away from||
1177|135|R|children and pets.||
1177|136|R|   Do not flush medications down the toilet or pour them into a||
1177|137|R|drain unless instructed to do so. Properly discard this product||
1177|138|R|when it is expired or no longer needed. Consult your pharmacist||
1177|139|R|or local waste disposal company.||
1177|140|B|||
1177|141|A|Information last revised September 2024.||
1177|142|A|Copyright(c) 2025 First Databank, Inc.||
1177|143|B|||
1178|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1178|002|Z|does NOT have all possible information about this product. This||
1178|003|Z|information does not assure that this product is safe, effective,||
1178|004|Z|or appropriate for you. This information is not individual||
1178|005|Z|medical advice and does not substitute for the advice of your||
1178|006|Z|health care professional. Always ask your health care||
1178|007|Z|professional for complete information about this product and your||
1178|008|Z|specific health needs.||
1178|009|B|||
1178|010|T|HEPATITIS B IMMUNE GLOBULIN - INJECTION||
1178|011|F|(hep-a-TYE-tis bee i-MYUN-GLOB-yoo-lin)||
1178|012|B|||
1178|013|C|COMMON BRAND NAME(S): Hepagam B, Hyperhep B, Nabi-HB||
1178|014|B|||
1178|015|W|WARNING:  This medication may rarely cause serious problems from||
1178|016|W|blood clots (such as heart attack, stroke, blood clots in the||
1178|017|W|lungs or legs). You may be at increased risk for blood clots if||
1178|018|W|you are an older adult, are severely dehydrated, have a catheter||
1178|019|W|in a vein close to your heart for giving medications, or have a||
1178|020|W|history of blood clots, heart/blood vessel disease, heart||
1178|021|W|failure, stroke, or if you are immobile (such as very long plane||
1178|022|W|flights or bedridden). If you use estrogen-containing products,||
1178|023|W|these may also increase your risk. Before using this medication,||
1178|024|W|discuss the risks and benefits and if you have any of these||
1178|025|W|conditions, report them to your doctor or pharmacist.||
1178|026|W|   Being adequately hydrated before and after receiving this||
1178|027|W|medication may help reduce your risk of blood clots. If you are||
1178|028|W|receiving this medication into a vein, the risk may also be||
1178|029|W|decreased by infusing this medication more slowly or by using a||
1178|030|W|less concentrated form of this medication if available.||
1178|031|W|   Get medical help right away if any of these side effects||
1178|032|W|occur: shortness of breath/rapid breathing, chest/jaw/left arm||
1178|033|W|pain, unusual sweating, sudden dizziness/fainting,||
1178|034|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1178|035|W|trouble speaking, weakness on one side of the body, sudden vision||
1178|036|W|changes, or confusion.||
1178|037|B|||
1178|038|U|USES:  This medication is used to prevent a certain serious virus||
1178|039|U|infection (hepatitis B) in people who have been exposed to this||
1178|040|U|virus under certain conditions (such as direct contact with blood||
1178|041|U|or body fluids containing this virus). Certain brands of this||
1178|042|U|medication may also be given after a liver transplant to prevent||
1178|043|U|return of hepatitis B infection in people with previous||
1178|044|U|infection. Ask your doctor or pharmacist if you have questions||
1178|045|U|about your particular brand. This medication is made from healthy||
1178|046|U|human blood that has high levels of certain defensive substances||
1178|047|U|(antibodies) that help fight hepatitis B.||
1178|048|B|||
1178|049|H|HOW TO USE:  If this medication is given for prevention of||
1178|050|H|hepatitis B after direct exposure to the virus, it is given by||
1178|051|H|injection into a muscle by a healthcare professional. It is best||
1178|052|H|to receive this medication as soon as possible after exposure. If||
1178|053|H|you wait too long after being exposed, the medication may not be||
1178|054|H|effective. Your doctor may also recommend vaccination after||
1178|055|H|receiving this medication. Talk with your doctor about the best||
1178|056|H|treatment for you.||
1178|057|H|   If this medication is given after a liver transplant to||
1178|058|H|prevent return of hepatitis B infection, it is given by injection||
1178|059|H|into a vein by a healthcare professional. For this use, it should||
1178|060|H|be given on a regular schedule. To help you remember, mark your||
1178|061|H|calendar with a reminder.||
1178|062|H|   The dosage and schedule of injections is based on your medical||
1178|063|H|condition, weight, and response to treatment.||
1178|064|B|||
1178|065|S|SIDE EFFECTS:  See also Warning section.||
1178|066|S|   Redness, pain, or tenderness at the injection site may occur.||
1178|067|S|Nausea, vomiting, fever, chills, dizziness, headache, or||
1178|068|S|back/joint pain may also occur. If any of these effects last or||
1178|069|S|get worse, tell your doctor or pharmacist promptly.||
1178|070|S|   Remember that this medication has been prescribed because your||
1178|071|S|doctor has judged that the benefit to you is greater than the||
1178|072|S|risk of side effects. Many people using this medication do not||
1178|073|S|have serious side effects.||
1178|074|S|   A very serious allergic reaction to this drug is rare.||
1178|075|S|However, get medical help right away if you notice any symptoms||
1178|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1178|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1178|078|S|breathing.||
1178|079|S|   This is not a complete list of possible side effects. If you||
1178|080|S|notice other effects not listed above, contact your doctor or||
1178|081|S|pharmacist promptly.||
1178|082|S|   In the US -||
1178|083|S|   Call your doctor for medical advice about side effects. You||
1178|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1178|085|S|www.fda.gov/medwatch.||
1178|086|S|   In Canada - Call your doctor for medical advice about side||
1178|087|S|effects. You may report side effects to Health Canada at||
1178|088|S|1-866-234-2345.||
1178|089|B|||
1178|090|P|PRECAUTIONS:  See also Warning section.||
1178|091|P|   Before receiving hepatitis B immune globulin, tell your doctor||
1178|092|P|or pharmacist if you are allergic to it; or to other immune||
1178|093|P|globulin products; or if you have any other allergies. This||
1178|094|P|product may contain inactive ingredients, which can cause||
1178|095|P|allergic reactions or other problems. Talk to your pharmacist for||
1178|096|P|more details.||
1178|097|P|   Before using this medication, tell your doctor or pharmacist||
1178|098|P|your medical history, especially of: bleeding/blood clotting||
1178|099|P|problems, a certain immune system problem (immunoglobulin A||
1178|100|P|deficiency).||
1178|101|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1178|102|P|can make you more dizzy. Do not drive, use machinery, or do||
1178|103|P|anything that needs alertness until you can do it safely. Limit||
1178|104|P|alcoholic beverages. Talk to your doctor if you are using||
1178|105|P|marijuana (cannabis).||
1178|106|P|   This medication is made from human blood. Even though the||
1178|107|P|blood is carefully tested, and this medication goes through a||
1178|108|P|special manufacturing process, there is an extremely small chance||
1178|109|P|that you may get infections (such as hepatitis A) from the||
1178|110|P|medication. Consult your doctor or pharmacist for more||
1178|111|P|information.||
1178|112|P|   Some immune globulin products are made with maltose. This||
1178|113|P|substance can cause false high blood sugar levels when your blood||
1178|114|P|sugar is normal or even low. If you have diabetes, check with||
1178|115|P|your doctor or pharmacist whether the product you are using||
1178|116|P|contains maltose and whether your blood sugar testing supplies||
1178|117|P|will work with this product. Rarely, serious problems have||
1178|118|P|occurred when too much insulin was given because of false high||
1178|119|P|sugar readings or when low blood sugar went untreated.||
1178|120|P|   Tell your doctor of any recent or planned||
1178|121|P|immunizations/vaccinations. This medication may prevent a good||
1178|122|P|response to certain live viral vaccines (such as measles, mumps,||
1178|123|P|rubella, varicella). If you have recently received any of these||
1178|124|P|vaccines, your doctor may have you tested for a response or have||
1178|125|P|you vaccinated again later. If you plan on getting any of these||
1178|126|P|vaccines, your doctor will instruct you about the best time to||
1178|127|P|receive them so you get a good response.||
1178|128|P|   Before having surgery, tell your doctor or dentist about all||
1178|129|P|the products you use (including prescription drugs,||
1178|130|P|nonprescription drugs, and herbal products).||
1178|131|P|   During pregnancy, this medication should be used only when||
1178|132|P|clearly needed. Discuss the risks and benefits with your doctor.||
1178|133|P|   It is unknown if this drug passes into breast milk. Consult||
1178|134|P|your doctor before breastfeeding.||
1178|135|B|||
1178|136|I|DRUG INTERACTIONS:  See also Warning section.||
1178|137|I|   Drug interactions may change how your medications work or||
1178|138|I|increase your risk for serious side effects. This document does||
1178|139|I|not contain all possible drug interactions. Keep a list of all||
1178|140|I|the products you use (including prescription/nonprescription||
1178|141|I|drugs and herbal products) and share it with your doctor and||
1178|142|I|pharmacist. Do not start, stop, or change the dosage of any||
1178|143|I|medicines without your doctor's approval.||
1178|144|I|   This medication may interfere with certain lab tests||
1178|145|I|(including certain blood sugar tests, Coomb's test), possibly||
1178|146|I|causing false test results. The blood sugar interference can lead||
1178|147|I|to serious (possibly fatal) consequences. Make sure lab personnel||
1178|148|I|and all your doctors and pharmacists know you use this drug, and||
1178|149|I|which type of blood sugar testing strips you use.||
1178|150|B|||
1178|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1178|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1178|153|O|poison control center right away. US residents can call||
1178|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1178|155|B|||
1178|156|N|NOTES:  If you are receiving this medication on a regular||
1178|157|N|schedule, lab and/or medical tests (such as levels of antibody in||
1178|158|N|the blood) may be done while you are using this medication. Keep||
1178|159|N|all medical and lab appointments. Consult your doctor for more||
1178|160|N|details.||
1178|161|B|||
1178|162|D|MISSED DOSE:  It is important to get each dose of this medication||
1178|163|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1178|164|D|right away for a new dosing schedule.||
1178|165|B|||
1178|166|R|STORAGE:  Not applicable. This medication is given in a hospital||
1178|167|R|or doctor's office and will not be stored at home.||
1178|168|B|||
1178|169|A|Information last revised June 2025.||
1178|170|A|Copyright(c) 2025 First Databank, Inc.||
1178|171|B|||
1179|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1179|002|Z|does NOT have all possible information about this product. This||
1179|003|Z|information does not assure that this product is safe, effective,||
1179|004|Z|or appropriate for you. This information is not individual||
1179|005|Z|medical advice and does not substitute for the advice of your||
1179|006|Z|health care professional. Always ask your health care||
1179|007|Z|professional for complete information about this product and your||
1179|008|Z|specific health needs.||
1179|009|B|||
1179|010|T|GRISEOFULVIN TABLET - ORAL||
1179|011|F|(GRISS-ee-oh-FULL-vin)||
1179|012|B|||
1179|013|C|COMMON BRAND NAME(S): Fulvicin, Grifulvin V, Gris-Peg, Grisactin||
1179|014|B|||
1179|015|U|USES:  This medication is used to treat fungal infections of the||
1179|016|U|skin, hair, and nails that do not respond to creams/lotions.||
1179|017|U|Clearing such infections will get rid of symptoms such as||
1179|018|U|itching, red/peeling/scaly skin, and discolored nails. This||
1179|019|U|medication works by stopping the growth of fungi. It does not||
1179|020|U|treat infections due to bacteria or yeast.||
1179|021|B|||
1179|022|H|HOW TO USE:  Take this medication by mouth as directed by your||
1179|023|H|doctor. For the best absorption, it is best taken with or after a||
1179|024|H|meal containing a moderate amount of fat. Talk to your doctor or||
1179|025|H|pharmacist about specific dietary instructions, especially if you||
1179|026|H|are on a low-fat diet.||
1179|027|H|   The dosage is based on your medical condition and response to||
1179|028|H|treatment. Children's dosage is also based on weight. The length||
1179|029|H|of treatment depends on the type of infection you have. It may||
1179|030|H|take several weeks to months to complete treatment for infections||
1179|031|H|of the scalp, feet, and body. Nail infections may require several||
1179|032|H|months to a year or longer to treat.||
1179|033|H|   Antifungal medications work best when the amount of medicine||
1179|034|H|in your body is kept at a constant level. Take this drug at||
1179|035|H|evenly spaced intervals.||
1179|036|H|   Continue to take this medication for the full time prescribed,||
1179|037|H|even if symptoms disappear after a few days. Stopping the||
1179|038|H|medication too early may result in a return of the infection.||
1179|039|H|   Tell your doctor if your condition lasts or gets worse.||
1179|040|B|||
1179|041|S|SIDE EFFECTS:  Headache, nausea, vomiting, diarrhea, stomach||
1179|042|S|upset, tiredness, dizziness, or trouble sleeping may occur. If||
1179|043|S|any of these effects last or get worse, tell your doctor or||
1179|044|S|pharmacist promptly.||
1179|045|S|   Remember that this medication has been prescribed because your||
1179|046|S|doctor has judged that the benefit to you is greater than the||
1179|047|S|risk of side effects. Many people using this medication do not||
1179|048|S|have serious side effects.||
1179|049|S|   Tell your doctor right away if you have any serious side||
1179|050|S|effects, including: numbness/tingling of the hands/feet,||
1179|051|S|mental/mood changes (such as confusion, trouble doing normal||
1179|052|S|activities), hearing changes, butterfly-shaped facial rash||
1179|053|S|(around the nose and cheeks), joint/muscle pain, signs of liver||
1179|054|S|disease (such as nausea/vomiting that doesn't stop,||
1179|055|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
1179|056|S|of kidney problems (such as change in the amount of urine, frothy||
1179|057|S|urine), signs of infection (such as sore throat that doesn't go||
1179|058|S|away, fever, chills).||
1179|059|S|   Use of this medication for prolonged or repeated periods may||
1179|060|S|result in oral thrush or a new vaginal yeast infection (oral or||
1179|061|S|vaginal fungal infection). Contact your doctor if you notice||
1179|062|S|white patches in your mouth, a change in vaginal discharge, or||
1179|063|S|other new symptoms.||
1179|064|S|   A very serious allergic reaction to this drug is rare.||
1179|065|S|However, get medical help right away if you notice any symptoms||
1179|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1179|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1179|068|S|breathing.||
1179|069|S|   This is not a complete list of possible side effects. If you||
1179|070|S|notice other effects not listed above, contact your doctor or||
1179|071|S|pharmacist.||
1179|072|S|   In the US -||
1179|073|S|   Call your doctor for medical advice about side effects. You||
1179|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1179|075|S|www.fda.gov/medwatch.||
1179|076|S|   In Canada - Call your doctor for medical advice about side||
1179|077|S|effects. You may report side effects to Health Canada at||
1179|078|S|1-866-234-2345.||
1179|079|B|||
1179|080|P|PRECAUTIONS:  Before taking griseofulvin, tell your doctor or||
1179|081|P|pharmacist if you are allergic to it; or if you have any other||
1179|082|P|allergies. This product may contain inactive ingredients, which||
1179|083|P|can cause allergic reactions or other problems. Talk to your||
1179|084|P|pharmacist for more details.||
1179|085|P|   Before using this medication, tell your doctor or pharmacist||
1179|086|P|your medical history, especially of: a certain blood disorder||
1179|087|P|(porphyria), liver disease, lupus.||
1179|088|P|   This drug may make you dizzy or less alert. Alcohol or||
1179|089|P|marijuana (cannabis) can make you more dizzy or much less alert.||
1179|090|P|Do not drive, use machinery, or do anything that needs alertness||
1179|091|P|until you can do it safely. Avoid alcoholic beverages while you||
1179|092|P|are taking this drug unless your doctor gives permission.||
1179|093|P|Drinking alcohol during treatment with this drug could result in||
1179|094|P|a fast heartbeat and flushing of the skin. Talk to your doctor if||
1179|095|P|you are using marijuana (cannabis).||
1179|096|P|   This medication may make you more sensitive to the sun. Limit||
1179|097|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1179|098|P|sunscreen and wear protective clothing when outdoors. Tell your||
1179|099|P|doctor right away if you get sunburned or have skin||
1179|100|P|blisters/redness.||
1179|101|P|   Tell your doctor if you are pregnant or plan to become||
1179|102|P|pregnant. You should not become pregnant while using||
1179|103|P|griseofulvin. Griseofulvin may harm an unborn baby. Ask about||
1179|104|P|reliable forms of birth control while using this medication and||
1179|105|P|for 1 month after the last dose. If you become pregnant, talk to||
1179|106|P|your doctor right away about the risks and benefits of this||
1179|107|P|medication. (See also Drug Interactions section.)||
1179|108|P|   The effects of this drug on human sperm are unknown. However,||
1179|109|P|based on animal cell studies, the manufacturer recommends waiting||
1179|110|P|for a period of time after completing griseofulvin treatment||
1179|111|P|before trying to father a child. Discuss the risks and benefits||
1179|112|P|with your doctor, and ask how long to wait after your last dose||
1179|113|P|before trying to father a child.||
1179|114|P|   It is unknown if this drug passes into breast milk. Consult||
1179|115|P|your doctor before breastfeeding.||
1179|116|B|||
1179|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1179|118|I|medications work or increase your risk for serious side effects.||
1179|119|I|This document does not contain all possible drug interactions.||
1179|120|I|Keep a list of all the products you use (including||
1179|121|I|prescription/nonprescription drugs and herbal products) and share||
1179|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
1179|123|I|the dosage of any medicines without your doctor's approval.||
1179|124|I|   Some products that may interact with this drug are:||
1179|125|I|barbiturates (such as phenobarbital), warfarin.||
1179|126|I|   This medication may decrease the effectiveness of hormonal||
1179|127|I|birth control such as pills, patch, or ring. This could cause||
1179|128|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1179|129|I|use reliable backup birth control methods while using this||
1179|130|I|medication. Also tell your doctor if you have any new spotting or||
1179|131|I|breakthrough bleeding, because these may be signs that your birth||
1179|132|I|control is not working well.||
1179|133|B|||
1179|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1179|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1179|136|O|poison control center right away. US residents can call||
1179|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1179|138|B|||
1179|139|N|NOTES:  Do not share this medication with others.||
1179|140|N|   This medication has been prescribed for your current condition||
1179|141|N|only. Do not use it later for another infection unless your||
1179|142|N|doctor tells you to.||
1179|143|N|   Lab and/or medical tests (such as kidney/liver function,||
1179|144|N|complete blood count) should be done while you are taking this||
1179|145|N|medication. Keep all medical and lab appointments. Consult your||
1179|146|N|doctor for more details.||
1179|147|N|   Ask your doctor or pharmacist about ways to control the||
1179|148|N|infection and to prevent re-infection. Fungus spreads easily in||
1179|149|N|warm, moist areas. Follow good hygiene (for example wash and dry||
1179|150|N|the infected area completely, and do not share articles of||
1179|151|N|clothing or objects that come in contact with the infected area).||
1179|152|B|||
1179|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1179|154|D|remember. If it is near the time of the next dose, skip the||
1179|155|D|missed dose. Take your next dose at the regular time. Do not||
1179|156|D|double the dose to catch up.||
1179|157|B|||
1179|158|R|STORAGE:  Store at room temperature away from light and moisture.||
1179|159|R|Do not store in the bathroom. Keep all medications away from||
1179|160|R|children and pets.||
1179|161|R|   Do not flush medications down the toilet or pour them into a||
1179|162|R|drain unless instructed to do so. Properly discard this product||
1179|163|R|when it is expired or no longer needed. Consult your pharmacist||
1179|164|R|or local waste disposal company.||
1179|165|B|||
1179|166|A|Information last revised April 2025.||
1179|167|A|Copyright(c) 2025 First Databank, Inc.||
1179|168|B|||
1180|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1180|002|Z|does NOT have all possible information about this product. This||
1180|003|Z|information does not assure that this product is safe, effective,||
1180|004|Z|or appropriate for you. This information is not individual||
1180|005|Z|medical advice and does not substitute for the advice of your||
1180|006|Z|health care professional. Always ask your health care||
1180|007|Z|professional for complete information about this product and your||
1180|008|Z|specific health needs.||
1180|009|B|||
1180|010|T|SILODOSIN - ORAL||
1180|011|F|(sye-LOE-doe-sin)||
1180|012|B|||
1180|013|C|COMMON BRAND NAME(S): Rapaflo||
1180|014|B|||
1180|015|U|USES:  Silodosin is used by men to treat the symptoms of an||
1180|016|U|enlarged prostate (benign prostatic hyperplasia-BPH). It does not||
1180|017|U|shrink the prostate, but it works by relaxing the muscles in the||
1180|018|U|prostate and the bladder. This helps to relieve symptoms of BPH||
1180|019|U|such as difficulty in beginning the flow of urine, weak stream,||
1180|020|U|and the need to urinate often or urgently (including during the||
1180|021|U|middle of the night).||
1180|022|U|   Silodosin belongs to a class of drugs known as alpha blockers.||
1180|023|U|   Do not use this medication to treat high blood pressure.||
1180|024|B|||
1180|025|V|OTHER USES:  This section contains uses of this drug that are not||
1180|026|V|listed in the approved professional labeling for the drug but||
1180|027|V|that may be prescribed by your health care professional. Use this||
1180|028|V|drug for a condition that is listed in this section only if it||
1180|029|V|has been so prescribed by your health care professional.||
1180|030|V|   Silodosin may also be used to help your body "pass," or get||
1180|031|V|rid of, kidney stones through urination.||
1180|032|B|||
1180|033|H|HOW TO USE:  Take this medication by mouth as directed by your||
1180|034|H|doctor, usually once daily with a meal.||
1180|035|H|   If you have difficulty swallowing this medication whole, you||
1180|036|H|may sprinkle the entire contents of a capsule on a small amount||
1180|037|H|(such as a tablespoon) of cool soft applesauce just before||
1180|038|H|taking. Swallow the mixture right away (within 5 minutes). Do not||
1180|039|H|chew the mixture, and do not save it for future use. Do not use||
1180|040|H|hot applesauce. Drink a glass of cool water after each dose.||
1180|041|H|   Silodosin may cause a sudden drop in your blood pressure,||
1180|042|H|which could lead to dizziness or fainting. This risk is higher||
1180|043|H|when you first start taking this drug, after your doctor||
1180|044|H|increases your dose, or if you restart treatment after you stop||
1180|045|H|taking it. During these times, avoid situations where you may be||
1180|046|H|injured if you faint.||
1180|047|H|   To avoid injury from dizziness or fainting, your doctor may||
1180|048|H|tell you to take your first dose of silodosin with food at||
1180|049|H|bedtime so that your body can get used to its effects.||
1180|050|H|   The dosage is based on your medical condition and response to||
1180|051|H|treatment.||
1180|052|H|   Take this medication regularly to get the most benefit from||
1180|053|H|it. To help you remember, take it with the same meal each day.||
1180|054|H|   Tell your doctor if your condition does not get better or if||
1180|055|H|it gets worse.||
1180|056|B|||
1180|057|S|SIDE EFFECTS:  Dizziness, lightheadedness, or ejaculation||
1180|058|S|problems may occur. If any of these effects last or get worse,||
1180|059|S|tell your doctor or pharmacist promptly.||
1180|060|S|   To reduce the risk of dizziness and lightheadedness, get up||
1180|061|S|slowly when rising from a sitting or lying position.||
1180|062|S|   Remember that this medication has been prescribed because your||
1180|063|S|doctor has judged that the benefit to you is greater than the||
1180|064|S|risk of side effects. Many people using this medication do not||
1180|065|S|have serious side effects.||
1180|066|S|   Tell your doctor right away if you have any serious side||
1180|067|S|effects, including: fainting.||
1180|068|S|   Rarely, males may have a painful or prolonged erection lasting||
1180|069|S|4 or more hours. If this occurs, stop using this drug and get||
1180|070|S|medical help right away, or permanent problems could occur.||
1180|071|S|   A very serious allergic reaction to this drug is rare.||
1180|072|S|However, get medical help right away if you notice any symptoms||
1180|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1180|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1180|075|S|breathing.||
1180|076|S|   This is not a complete list of possible side effects. If you||
1180|077|S|notice other effects not listed above, contact your doctor or||
1180|078|S|pharmacist.||
1180|079|S|   In the US -||
1180|080|S|   Call your doctor for medical advice about side effects. You||
1180|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1180|082|S|www.fda.gov/medwatch.||
1180|083|S|   In Canada - Call your doctor for medical advice about side||
1180|084|S|effects. You may report side effects to Health Canada at||
1180|085|S|1-866-234-2345.||
1180|086|B|||
1180|087|P|PRECAUTIONS:  Before taking silodosin, tell your doctor or||
1180|088|P|pharmacist if you are allergic to it; or if you have any other||
1180|089|P|allergies. This product may contain inactive ingredients, which||
1180|090|P|can cause allergic reactions or other problems. Talk to your||
1180|091|P|pharmacist for more details.||
1180|092|P|   Before using this medication, tell your doctor or pharmacist||
1180|093|P|your medical history, especially of: kidney disease, liver||
1180|094|P|disease, low blood pressure, certain eye problems (cataracts,||
1180|095|P|glaucoma).||
1180|096|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1180|097|P|can make you more dizzy. Do not drive, use machinery, or do||
1180|098|P|anything that needs alertness until you can do it safely. Limit||
1180|099|P|alcoholic beverages. Talk to your doctor if you are using||
1180|100|P|marijuana (cannabis).||
1180|101|P|   Before having surgery (including cataract/glaucoma eye||
1180|102|P|surgery), tell your doctor or dentist if you are taking or have||
1180|103|P|ever taken this medication, and about all the other products you||
1180|104|P|use (including prescription drugs, nonprescription drugs, and||
1180|105|P|herbal products).||
1180|106|P|   Older adults may be more sensitive to the side effects of this||
1180|107|P|drug, especially dizziness and low blood pressure when getting up||
1180|108|P|from a sitting or lying position. These side effects can increase||
1180|109|P|the risk of falling.||
1180|110|P|   During pregnancy, this medication should be used only when||
1180|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
1180|112|P|   It is unknown if this medication passes into breast milk.||
1180|113|P|Consult your doctor before breastfeeding.||
1180|114|B|||
1180|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1180|116|I|medications work or increase your risk for serious side effects.||
1180|117|I|This document does not contain all possible drug interactions.||
1180|118|I|Keep a list of all the products you use (including||
1180|119|I|prescription/nonprescription drugs and herbal products) and share||
1180|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1180|121|I|the dosage of any medicines without your doctor's approval.||
1180|122|I|   Some products that may interact with this drug include: other||
1180|123|I|alpha blocker drugs (such as prazosin, terazosin).||
1180|124|I|   If you are also taking a drug to treat erectile dysfunction-ED||
1180|125|I|or pulmonary hypertension (such as sildenafil, tadalafil), your||
1180|126|I|blood pressure may get too low which can lead to dizziness or||
1180|127|I|fainting. Your doctor may need to adjust your medications to||
1180|128|I|minimize this risk.||
1180|129|I|   Other medications can affect the removal of silodosin from||
1180|130|I|your body, which may affect how silodosin works. Examples include||
1180|131|I|adagrasib, azole antifungals (such as itraconazole,||
1180|132|I|ketoconazole), clarithromycin, cobicistat, cyclosporine, HIV||
1180|133|I|protease inhibitors (such as lopinavir), mifepristone,||
1180|134|I|ribociclib, ritonavir, among others.||
1180|135|B|||
1180|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1180|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1180|138|O|poison control center right away. US residents can call||
1180|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1180|140|O|Symptoms of overdose may include: severe dizziness, fainting.||
1180|141|B|||
1180|142|N|NOTES:  Do not share this medication with others.||
1180|143|N|   Lab and/or medical tests (such as prostate exams, blood||
1180|144|N|pressure) should be done while you are taking this medication.||
1180|145|N|Keep all medical and lab appointments. Consult your doctor for||
1180|146|N|more details.||
1180|147|B|||
1180|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1180|149|D|remember. If it is near the time of the next dose, skip the||
1180|150|D|missed dose. Take your next dose at the regular time. Do not||
1180|151|D|double the dose to catch up.||
1180|152|B|||
1180|153|R|STORAGE:  Store at room temperature away from light and moisture.||
1180|154|R|Do not store in the bathroom. Keep all medications away from||
1180|155|R|children and pets.||
1180|156|R|   Do not flush medications down the toilet or pour them into a||
1180|157|R|drain unless instructed to do so. Properly discard this product||
1180|158|R|when it is expired or no longer needed. Consult your pharmacist||
1180|159|R|or local waste disposal company.||
1180|160|B|||
1180|161|A|Information last revised October 2024.||
1180|162|A|Copyright(c) 2025 First Databank, Inc.||
1180|163|B|||
1181|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1181|002|Z|does NOT have all possible information about this product. This||
1181|003|Z|information does not assure that this product is safe, effective,||
1181|004|Z|or appropriate for you. This information is not individual||
1181|005|Z|medical advice and does not substitute for the advice of your||
1181|006|Z|health care professional. Always ask your health care||
1181|007|Z|professional for complete information about this product and your||
1181|008|Z|specific health needs.||
1181|009|B|||
1181|010|T|SULFUR - TOPICAL||
1181|011|F|(SULL-fur/AL-kuh-hall)||
1181|012|B|||
1181|013|C|COMMON BRAND NAME(S): Liquimat||
1181|014|B|||
1181|015|U|USES:  This product is used to cover up and treat acne. It helps||
1181|016|U|to decrease the number of acne pimples. It contains sulfur, a||
1181|017|U|drug that is thought to work by stopping the growth of bacteria||
1181|018|U|that cause acne and helping the top layer of skin to shed||
1181|019|U|(keratolysis).||
1181|020|B|||
1181|021|H|HOW TO USE:  Use this medication on the skin only. Clean the area||
1181|022|H|to be treated. Apply a thin layer of the medication to the||
1181|023|H|affected area and gently rub in, usually 1 to 3 times daily as||
1181|024|H|directed on the product package or as directed by your doctor.||
1181|025|H|Wash your hands after using the medication. If you have any||
1181|026|H|questions, ask your doctor or pharmacist.||
1181|027|H|   Do not apply the medication in the eyes, nose, or mouth or on||
1181|028|H|skin that is injured or irritated (for example, cut or scraped).||
1181|029|H|If you do get the medication in those areas, flush with plenty of||
1181|030|H|water.||
1181|031|H|   Tell your doctor if your condition lasts or gets worse. If you||
1181|032|H|think you may have a serious medical problem, get medical help||
1181|033|H|right away.||
1181|034|B|||
1181|035|S|SIDE EFFECTS:  Dryness, irritation, or peeling at the application||
1181|036|S|site may occur. These effects may be decreased by applying the||
1181|037|S|medication less often. If any of these effects last or get worse,||
1181|038|S|tell your doctor or pharmacist promptly.||
1181|039|S|   If your doctor has directed you to use this medication,||
1181|040|S|remember that your doctor has judged that the benefit to you is||
1181|041|S|greater than the risk of side effects. Many people using this||
1181|042|S|medication do not have serious side effects.||
1181|043|S|   A very serious allergic reaction to this drug is rare.||
1181|044|S|However, get medical help right away if you notice any symptoms||
1181|045|S|of a serious allergic reaction, including: rash, itching/swelling||
1181|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1181|047|S|breathing.||
1181|048|S|   This is not a complete list of possible side effects. If you||
1181|049|S|notice other effects not listed above, contact your doctor or||
1181|050|S|pharmacist.||
1181|051|S|   In the US -||
1181|052|S|   Call your doctor for medical advice about side effects. You||
1181|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1181|054|S|www.fda.gov/medwatch.||
1181|055|S|   In Canada - Call your doctor for medical advice about side||
1181|056|S|effects. You may report side effects to Health Canada at||
1181|057|S|1-866-234-2345.||
1181|058|B|||
1181|059|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1181|060|P|pharmacist if you are allergic to it; or if you have any other||
1181|061|P|allergies. This product may contain inactive ingredients, which||
1181|062|P|can cause allergic reactions or other problems. Talk to your||
1181|063|P|pharmacist for more details.||
1181|064|P|   Before using this medication, tell your doctor or pharmacist||
1181|065|P|your medical history.||
1181|066|P|   Before having surgery, tell your doctor or dentist about all||
1181|067|P|the products you use (including prescription drugs,||
1181|068|P|nonprescription drugs, and herbal products).||
1181|069|P|   During pregnancy, this medication should be used only when||
1181|070|P|clearly needed. Discuss the risks and benefits with your doctor.||
1181|071|P|   It is unknown if this drug passes into breast milk. Consult||
1181|072|P|your doctor before breastfeeding.||
1181|073|B|||
1181|074|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1181|075|I|medications work or increase your risk for serious side effects.||
1181|076|I|This document does not contain all possible drug interactions.||
1181|077|I|Keep a list of all the products you use (including||
1181|078|I|prescription/nonprescription drugs and herbal products) and share||
1181|079|I|it with your doctor and pharmacist. Do not start, stop, or change||
1181|080|I|the dosage of any medicines without your doctor's approval.||
1181|081|B|||
1181|082|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1181|083|O|has overdosed and has serious symptoms such as passing out or||
1181|084|O|trouble breathing, call 911. Otherwise, call a poison control||
1181|085|O|center right away. US residents can call 1-800-222-1222. Canada||
1181|086|O|residents can call 1-844-764-7669.||
1181|087|B|||
1181|088|N|NOTES:  Keep all medical and lab appointments.||
1181|089|B|||
1181|090|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1181|091|D|If it is near the time of the next dose, skip the missed dose.||
1181|092|D|Use your next dose at the regular time. Do not double the dose to||
1181|093|D|catch up.||
1181|094|B|||
1181|095|R|STORAGE:  Refer to storage information printed on the package. If||
1181|096|R|you have any questions about storage, ask your pharmacist. Keep||
1181|097|R|all medications away from children and pets.||
1181|098|R|   Do not flush medications down the toilet or pour them into a||
1181|099|R|drain unless instructed to do so. Properly discard this product||
1181|100|R|when it is expired or no longer needed. Consult your pharmacist||
1181|101|R|or local waste disposal company.||
1181|102|B|||
1181|103|A|Information last revised October 2024.||
1181|104|A|Copyright(c) 2025 First Databank, Inc.||
1181|105|B|||
1182|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1182|002|Z|does NOT have all possible information about this product. This||
1182|003|Z|information does not assure that this product is safe, effective,||
1182|004|Z|or appropriate for you. This information is not individual||
1182|005|Z|medical advice and does not substitute for the advice of your||
1182|006|Z|health care professional. Always ask your health care||
1182|007|Z|professional for complete information about this product and your||
1182|008|Z|specific health needs.||
1182|009|B|||
1182|010|T|FESOTERODINE EXTENDED-RELEASE - ORAL||
1182|011|F|(FES-oh-TER-oh-deen)||
1182|012|B|||
1182|013|C|COMMON BRAND NAME(S): Toviaz||
1182|014|B|||
1182|015|U|USES:  This medication is used to treat certain bladder problems||
1182|016|U|(overactive bladder, neurogenic detrusor overactivity).||
1182|017|U|Overactive bladder is a problem with how your bladder stores||
1182|018|U|urine. Neurogenic detrusor overactivity is a bladder control||
1182|019|U|condition caused by brain, spinal cord, or nerve problems.||
1182|020|U|Symptoms of these conditions may include frequent urination,||
1182|021|U|strong sudden urges to urinate that are hard to control, or||
1182|022|U|involuntary loss of urine (incontinence). By relaxing the muscles||
1182|023|U|in the bladder, fesoterodine improves your ability to control||
1182|024|U|your urination. It helps to reduce leaking of urine, feelings of||
1182|025|U|needing to urinate right away, and frequent trips to the||
1182|026|U|bathroom. This medication belongs to the class of drugs known as||
1182|027|U|antispasmodics.||
1182|028|B|||
1182|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1182|030|H|from your pharmacist before you start using fesoterodine and each||
1182|031|H|time you get a refill. If you have any questions, ask your doctor||
1182|032|H|or pharmacist.||
1182|033|H|   Take this medication by mouth with or without food as directed||
1182|034|H|by your doctor, usually once a day. Take each dose with a full||
1182|035|H|glass of liquid. Swallow the tablets whole. Do not crush or chew||
1182|036|H|the tablets. Doing so can release all of the drug at once,||
1182|037|H|increasing the risk of side effects.||
1182|038|H|   The dosage is based on your medical condition, other||
1182|039|H|medications you are taking, and response to treatment. Children's||
1182|040|H|dosage may also be based on weight. Be sure to tell your doctor||
1182|041|H|and pharmacist about all the products you use (including||
1182|042|H|prescription drugs, nonprescription drugs, and herbal products).||
1182|043|H|   Use this medication regularly in order to get the most benefit||
1182|044|H|from it. Remember to use it at the same time each day.||
1182|045|H|   Do not increase your dose or take this medication more often||
1182|046|H|without your doctor's approval. Your condition will not improve||
1182|047|H|any faster and the risk of serious side effects may be increased.||
1182|048|H|   Tell your doctor if your condition does not get better or if||
1182|049|H|it gets worse.||
1182|050|B|||
1182|051|S|SIDE EFFECTS:  Dry mouth, dry eyes, constipation, dizziness,||
1182|052|S|drowsiness, or blurred vision may occur. If any of these effects||
1182|053|S|last or get worse, notify your doctor or pharmacist promptly.||
1182|054|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
1182|055|S|chips, chew (sugarless) gum, drink water or use a saliva||
1182|056|S|substitute.||
1182|057|S|   To prevent constipation, eat dietary fiber, drink enough||
1182|058|S|water, and exercise. You may also need to take a laxative. Ask||
1182|059|S|your pharmacist which type of laxative is right for you.||
1182|060|S|   Remember that this medication has been prescribed because your||
1182|061|S|doctor has judged that the benefit to you is greater than the||
1182|062|S|risk of side effects. Many people using this medication do not||
1182|063|S|have serious side effects.||
1182|064|S|   Tell your doctor right away if you have any serious side||
1182|065|S|effects, including: constipation lasting 3 or more days, severe||
1182|066|S|stomach/abdominal pain, trouble urinating, signs of kidney||
1182|067|S|infection (such as burning/painful urination, lower back pain,||
1182|068|S|fever).||
1182|069|S|   Get medical help right away if you have any very serious side||
1182|070|S|effects, including: fast heartbeat, fainting.||
1182|071|S|   A very serious allergic reaction to this drug is rare.||
1182|072|S|However, get medical help right away if you notice any symptoms||
1182|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1182|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1182|075|S|breathing.||
1182|076|S|   This is not a complete list of possible side effects. If you||
1182|077|S|notice other effects not listed above, contact your doctor or||
1182|078|S|pharmacist.||
1182|079|S|   In the US -||
1182|080|S|   Call your doctor for medical advice about side effects. You||
1182|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1182|082|S|www.fda.gov/medwatch.||
1182|083|S|   In Canada - Call your doctor for medical advice about side||
1182|084|S|effects. You may report side effects to Health Canada at||
1182|085|S|1-866-234-2345.||
1182|086|B|||
1182|087|P|PRECAUTIONS:  Before taking fesoterodine, tell your doctor or||
1182|088|P|pharmacist if you are allergic to it; or to tolterodine; or if||
1182|089|P|you have any other allergies. This product may contain inactive||
1182|090|P|ingredients, which can cause allergic reactions or other||
1182|091|P|problems. Talk to your pharmacist for more details.||
1182|092|P|   Before using this medication, tell your doctor or pharmacist||
1182|093|P|your medical history, especially of: problems emptying your||
1182|094|P|bladder (urinary retention, bladder outflow obstruction),||
1182|095|P|stomach/intestinal problems (such as blockage, constipation,||
1182|096|P|ulcerative colitis, slowed movement of stomach/intestines), a||
1182|097|P|certain eye condition (narrow-angle glaucoma), kidney disease,||
1182|098|P|liver disease, a certain muscle disease (myasthenia gravis).||
1182|099|P|   This drug may make you dizzy or drowsy or blur your vision.||
1182|100|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1182|101|P|drowsy. Do not drive, use machinery, or do anything that needs||
1182|102|P|alertness or clear vision until you can do it safely. Limit||
1182|103|P|alcoholic beverages. Talk to your doctor if you are using||
1182|104|P|marijuana (cannabis).||
1182|105|P|   Before having surgery, tell your doctor or dentist about all||
1182|106|P|the products you use (including prescription drugs,||
1182|107|P|nonprescription drugs, and herbal products).||
1182|108|P|   This medication may make you sweat less, making you more||
1182|109|P|likely to get heat stroke. Avoid doing things that may cause you||
1182|110|P|to overheat, such as hard work or exercise in hot weather, or||
1182|111|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1182|112|P|and dress lightly. If you overheat, quickly look for a place to||
1182|113|P|cool down and rest. Get medical help right away if you have a||
1182|114|P|fever that does not go away, mental/mood changes, headache, or||
1182|115|P|dizziness.||
1182|116|P|   Older adults may be more sensitive to the side effects of this||
1182|117|P|drug, especially dizziness, dry mouth, and constipation.||
1182|118|P|   During pregnancy, this medication should be used only when||
1182|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
1182|120|P|   It is unknown if this drug passes into breast milk. Consult||
1182|121|P|your doctor before breastfeeding.||
1182|122|B|||
1182|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1182|124|I|medications work or increase your risk for serious side effects.||
1182|125|I|This document does not contain all possible drug interactions.||
1182|126|I|Keep a list of all the products you use (including||
1182|127|I|prescription/nonprescription drugs and herbal products) and share||
1182|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
1182|129|I|the dosage of any medicines without your doctor's approval.||
1182|130|I|   Some products that may interact with this drug include:||
1182|131|I|pramlintide, potassium tablets/capsules.||
1182|132|I|   Other medications can affect the removal of fesoterodine from||
1182|133|I|your body, which may affect how fesoterodine works. Examples||
1182|134|I|include certain azole antifungals (such as itraconazole,||
1182|135|I|ketoconazole), mifepristone, among others.||
1182|136|I|   Tell your doctor or pharmacist if you are taking other||
1182|137|I|products that cause drowsiness such as opioid pain or cough||
1182|138|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1182|139|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1182|140|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1182|141|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1182|142|I|diphenhydramine).||
1182|143|I|   Check the labels on all your medicines (such as allergy or||
1182|144|I|cough-and-cold products) because they may contain ingredients||
1182|145|I|that can cause drowsiness, constipation or blurred vision. Ask||
1182|146|I|your pharmacist about the safe use of those products.||
1182|147|B|||
1182|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1182|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1182|150|O|poison control center right away. US residents can call||
1182|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1182|152|O|Symptoms of overdose may include severe drowsiness or||
1182|153|O|unconsciousness, unusual excitement, mental/mood changes.||
1182|154|B|||
1182|155|N|NOTES:  Do not share this medication with others.||
1182|156|B|||
1182|157|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1182|158|D|If it is near the time of the next dose, skip the missed dose.||
1182|159|D|Use your next dose at the regular time. Do not double the dose to||
1182|160|D|catch up.||
1182|161|B|||
1182|162|R|STORAGE:  Store at room temperature away from light and moisture.||
1182|163|R|Do not store in the bathroom. Keep all medications away from||
1182|164|R|children and pets.||
1182|165|R|   Do not flush medications down the toilet or pour them into a||
1182|166|R|drain unless instructed to do so. Properly discard this product||
1182|167|R|when it is expired or no longer needed. Consult your pharmacist||
1182|168|R|or local waste disposal company.||
1182|169|B|||
1182|170|A|Information last revised October 2025.||
1182|171|A|Copyright(c) 2025 First Databank, Inc.||
1182|172|B|||
1183|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1183|002|Z|does NOT have all possible information about this product. This||
1183|003|Z|information does not assure that this product is safe, effective,||
1183|004|Z|or appropriate for you. This information is not individual||
1183|005|Z|medical advice and does not substitute for the advice of your||
1183|006|Z|health care professional. Always ask your health care||
1183|007|Z|professional for complete information about this product and your||
1183|008|Z|specific health needs.||
1183|009|B|||
1183|010|T|FENOFIBRIC ACID DELAYED-RELEASE - ORAL||
1183|011|F|(FEN-oh-FYE-brick AS-id)||
1183|012|B|||
1183|013|C|COMMON BRAND NAME(S): Trilipix||
1183|014|B|||
1183|015|U|USES:  Fenofibric acid is used along with a proper diet to help||
1183|016|U|lower "bad" cholesterol and fats (such as LDL, triglycerides) and||
1183|017|U|raise "good" cholesterol (HDL) in the blood. It works by||
1183|018|U|increasing the natural substance (enzyme) that breaks down fats||
1183|019|U|in the blood. Fenofibric acid belongs to a group of drugs known||
1183|020|U|as "fibrates." Lowering triglycerides in people with very high||
1183|021|U|triglyceride blood levels may decrease the risk of pancreas||
1183|022|U|disease (pancreatitis). However, fenofibric acid might not lower||
1183|023|U|your risk of a heart attack or stroke. Talk to your doctor about||
1183|024|U|the risks and benefits of fenofibric acid.||
1183|025|U|   In addition to eating a proper diet (such as a||
1183|026|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
1183|027|U|help this medication work better include exercising, losing||
1183|028|U|weight if overweight, and stopping smoking. Consult your doctor||
1183|029|U|for more details.||
1183|030|B|||
1183|031|H|HOW TO USE:  Take this medication by mouth with or without food||
1183|032|H|as directed by your doctor, usually once daily.||
1183|033|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
1183|034|H|Doing so can release all of the drug at once, increasing the risk||
1183|035|H|of side effects.||
1183|036|H|   The dosage is based on your medical condition and response to||
1183|037|H|treatment.||
1183|038|H|   If you are also taking certain other drugs to lower your||
1183|039|H|cholesterol (bile acid-binding resins such as cholestyramine or||
1183|040|H|colestipol), take fenofibric acid at least 1 hour before or at||
1183|041|H|least 4 to 6 hours after taking these medications. These||
1183|042|H|medications can bind to fenofibric acid, preventing your body||
1183|043|H|from fully absorbing the drug.||
1183|044|H|   Take this medication regularly to get the most benefit from||
1183|045|H|it. To help you remember, take it at the same time each day. Do||
1183|046|H|not increase your dose or use this drug more often or for longer||
1183|047|H|than prescribed. Your cholesterol/triglycerides level will not||
1183|048|H|lower faster, and your risk of side effects will increase. Keep||
1183|049|H|taking this medication even if you feel well. Most people with||
1183|050|H|high cholesterol/triglycerides do not feel sick.||
1183|051|H|   It is very important to continue to follow your doctor's||
1183|052|H|advice about diet and exercise. It may take up to 2 months before||
1183|053|H|you get the full benefit of this medication.||
1183|054|B|||
1183|055|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1183|056|S|because your doctor has judged that the benefit to you is greater||
1183|057|S|than the risk of side effects. Many people using this medication||
1183|058|S|do not have serious side effects.||
1183|059|S|   This medication may rarely cause gallstones and liver||
1183|060|S|problems. If you notice any of the following unlikely but serious||
1183|061|S|side effects, tell your doctor right away: nausea/vomiting that||
1183|062|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
1183|063|S|eyes/skin, dark urine.||
1183|064|S|   This drug may rarely cause muscle problems (which can rarely||
1183|065|S|lead to a very serious condition called rhabdomyolysis). Tell||
1183|066|S|your doctor right away if you develop any of these symptoms:||
1183|067|S|muscle pain/tenderness/weakness (especially with fever or unusual||
1183|068|S|tiredness), signs of kidney problems (such as change in the||
1183|069|S|amount of urine).||
1183|070|S|   Rarely, this medication has caused severe lowering of HDL||
1183|071|S|("good" cholesterol) levels. This is the opposite of what should||
1183|072|S|happen to your HDL levels (paradoxical reaction). Your HDL||
1183|073|S|cholesterol levels should be checked regularly. Keep all of your||
1183|074|S|lab appointments.||
1183|075|S|   Tell your doctor right away if you have any serious side||
1183|076|S|effects, including: easy bleeding/bruising, unusual tiredness.||
1183|077|S|   Get medical help right away if you have any very serious side||
1183|078|S|effects, including: chest pain, sudden pain/redness/swelling||
1183|079|S|usually in the leg, signs of infection (such as sore throat that||
1183|080|S|doesn't go away, fever, swollen lymph nodes, chills).||
1183|081|S|   A very serious allergic reaction to this drug is rare.||
1183|082|S|However, get medical help right away if you notice any symptoms||
1183|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1183|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1183|085|S|breathing.||
1183|086|S|   This is not a complete list of possible side effects. If you||
1183|087|S|notice other effects not listed above, contact your doctor or||
1183|088|S|pharmacist.||
1183|089|S|   In the US -||
1183|090|S|   Call your doctor for medical advice about side effects. You||
1183|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1183|092|S|www.fda.gov/medwatch.||
1183|093|S|   In Canada - Call your doctor for medical advice about side||
1183|094|S|effects. You may report side effects to Health Canada at||
1183|095|S|1-866-234-2345.||
1183|096|B|||
1183|097|P|PRECAUTIONS:  Before taking fenofibric acid, tell your doctor or||
1183|098|P|pharmacist if you are allergic to it; or to other "fibrates"||
1183|099|P|(such as fenofibrate); or if you have any other allergies. This||
1183|100|P|product may contain inactive ingredients, which can cause||
1183|101|P|allergic reactions or other problems. Talk to your pharmacist for||
1183|102|P|more details.||
1183|103|P|   Before using this medication, tell your doctor or pharmacist||
1183|104|P|your medical history, especially of: liver disease (such as||
1183|105|P|biliary cholangitis, hepatitis), gallbladder disease, alcohol||
1183|106|P|use, kidney disease.||
1183|107|P|   Before having surgery, tell your doctor or dentist about all||
1183|108|P|the products you use (including prescription drugs,||
1183|109|P|nonprescription drugs, and herbal products).||
1183|110|P|   Older adults may be more sensitive to the side effects of this||
1183|111|P|drug, especially muscle problems.||
1183|112|P|   During pregnancy, this medication should be used only when||
1183|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
1183|114|P|   It is unknown if this medication passes into breast milk.||
1183|115|P|Because of the possible risk to the infant, breastfeeding is not||
1183|116|P|recommended while using this medication and for 5 days after the||
1183|117|P|last dose. Consult your doctor before breastfeeding.||
1183|118|B|||
1183|119|I|DRUG INTERACTIONS:  See also How to Use section.||
1183|120|I|   Drug interactions may change how your medications work or||
1183|121|I|increase your risk for serious side effects. This document does||
1183|122|I|not contain all possible drug interactions. Keep a list of all||
1183|123|I|the products you use (including prescription/nonprescription||
1183|124|I|drugs and herbal products) and share it with your doctor and||
1183|125|I|pharmacist. Do not start, stop, or change the dosage of any||
1183|126|I|medicines without your doctor's approval.||
1183|127|I|   Some products that may interact with this drug include: "blood||
1183|128|I|thinners" (such as warfarin).||
1183|129|I|   Fenofibric acid is very similar to fenofibrate. Do not use||
1183|130|I|medications containing fenofibrate while using fenofibric acid.||
1183|131|B|||
1183|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1183|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1183|134|O|poison control center right away. US residents can call||
1183|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1183|136|B|||
1183|137|N|NOTES:  Do not share this medication with others.||
1183|138|N|   Lab and/or medical tests (such as cholesterol/triglyceride||
1183|139|N|levels, kidney/liver function, complete blood count) should be||
1183|140|N|done while you are taking this medication. Keep all medical and||
1183|141|N|lab appointments. Consult your doctor for more details. (See also||
1183|142|N|Side Effects section.)||
1183|143|B|||
1183|144|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1183|145|D|next dose at the regular time. Do not double the dose to catch||
1183|146|D|up.||
1183|147|B|||
1183|148|R|STORAGE:  Store at room temperature away from light and moisture.||
1183|149|R|Do not store in the bathroom. Keep all medications away from||
1183|150|R|children and pets.||
1183|151|R|   Do not flush medications down the toilet or pour them into a||
1183|152|R|drain unless instructed to do so. Properly discard this product||
1183|153|R|when it is expired or no longer needed. Consult your pharmacist||
1183|154|R|or local waste disposal company.||
1183|155|B|||
1183|156|A|Information last revised June 2025.||
1183|157|A|Copyright(c) 2025 First Databank, Inc.||
1183|158|B|||
1184|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1184|002|Z|does NOT have all possible information about this product. This||
1184|003|Z|information does not assure that this product is safe, effective,||
1184|004|Z|or appropriate for you. This information is not individual||
1184|005|Z|medical advice and does not substitute for the advice of your||
1184|006|Z|health care professional. Always ask your health care||
1184|007|Z|professional for complete information about this product and your||
1184|008|Z|specific health needs.||
1184|009|B|||
1184|010|T|LACOSAMIDE - ORAL||
1184|011|F|(la-KOE-sa-mide)||
1184|012|B|||
1184|013|C|COMMON BRAND NAME(S):  Vimpat||
1184|014|B|||
1184|015|U|USES:  Lacosamide is used to prevent and control seizures. It is||
1184|016|U|an anticonvulsant or antiepileptic drug. It works by reducing the||
1184|017|U|spread of seizure activity in the brain.||
1184|018|B|||
1184|019|V|OTHER USES:  This section contains uses of this drug that are not||
1184|020|V|listed in the approved professional labeling for the drug but||
1184|021|V|that may be prescribed by your health care professional. Use this||
1184|022|V|drug for a condition that is listed in this section only if it||
1184|023|V|has been so prescribed by your health care professional.||
1184|024|V|   This medication may also be used for nerve pain.||
1184|025|B|||
1184|026|H|HOW TO USE:  Read the Medication Guide provided by your||
1184|027|H|pharmacist before you start taking lacosamide and each time you||
1184|028|H|get a refill. If you have any questions, ask your doctor or||
1184|029|H|pharmacist.||
1184|030|H|   Take this medication by mouth with or without food as directed||
1184|031|H|by your doctor, usually twice daily.||
1184|032|H|   The manufacturer directs to swallow the tablet form of this||
1184|033|H|medication whole. However, many similar drugs (immediate-release||
1184|034|H|tablets) can be split/crushed. Follow your doctor's directions on||
1184|035|H|how to take this medication.||
1184|036|H|   If you are using the liquid form of this medication, carefully||
1184|037|H|measure the dose using a special measuring device/spoon. Do not||
1184|038|H|use a household spoon because you may not get the correct dose.||
1184|039|H|   The dosage is based on your medical condition and response to||
1184|040|H|treatment. Children's dosage is also based on weight. To reduce||
1184|041|H|your risk of side effects, your doctor may direct you to start||
1184|042|H|this medication at a low dose and gradually increase your dose.||
1184|043|H|Follow your doctor's instructions carefully.||
1184|044|H|   This medication works best when the amount of drug in your||
1184|045|H|body is kept at a constant level. Take this drug at evenly spaced||
1184|046|H|intervals. To help you remember, take it at the same times each||
1184|047|H|day.||
1184|048|H|   Do not stop taking this medication without consulting your||
1184|049|H|doctor. Seizures may become worse when the drug is suddenly||
1184|050|H|stopped. Your dose may need to be gradually decreased. Consult||
1184|051|H|your doctor or pharmacist for more details.||
1184|052|H|   Though it helps many people, this medication may sometimes||
1184|053|H|cause addiction. This risk may be higher if you have a substance||
1184|054|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1184|055|H|Take this medication exactly as prescribed to lower the risk of||
1184|056|H|addiction. Ask your doctor or pharmacist for more details.||
1184|057|H|   Tell your doctor right away if your seizure control gets worse||
1184|058|H|(such as the number of seizures increases).||
1184|059|B|||
1184|060|S|SIDE EFFECTS:  Dizziness, drowsiness, blurred/double vision,||
1184|061|S|nausea, vomiting, tiredness, unsteadiness, or shakiness (tremor)||
1184|062|S|may occur as your body adjusts to the medication. If any of these||
1184|063|S|effects last or get worse, tell your doctor or pharmacist||
1184|064|S|promptly.||
1184|065|S|   Remember that this medication has been prescribed because your||
1184|066|S|doctor has judged that the benefit to you is greater than the||
1184|067|S|risk of side effects. Many people using this medication do not||
1184|068|S|have serious side effects.||
1184|069|S|   Get medical help right away if you have any very serious side||
1184|070|S|effects, including: fast/slow/irregular/pounding heartbeat, chest||
1184|071|S|pain, shortness of breath, severe dizziness, fainting.||
1184|072|S|   A small number of people who take anticonvulsants for any||
1184|073|S|condition (such as seizure, bipolar disorder, pain) may||
1184|074|S|experience depression, suicidal thoughts/attempts, or other||
1184|075|S|mental/mood problems. Tell your doctor right away if you or your||
1184|076|S|family/caregiver notice any unusual/sudden changes in your mood,||
1184|077|S|thoughts, or behavior such as signs of depression, suicidal||
1184|078|S|thoughts/attempts, thoughts about harming yourself.||
1184|079|S|   A very serious allergic reaction to this drug is rare.||
1184|080|S|However, get medical help right away if you notice any symptoms||
1184|081|S|of a serious allergic reaction, including: fever, swollen lymph||
1184|082|S|nodes, rash, itching/swelling (especially of the||
1184|083|S|face/tongue/throat), severe dizziness, trouble breathing.||
1184|084|S|   This is not a complete list of possible side effects. If you||
1184|085|S|notice other effects not listed above, contact your doctor or||
1184|086|S|pharmacist.||
1184|087|S|   In the US -||
1184|088|S|   Call your doctor for medical advice about side effects. You||
1184|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1184|090|S|www.fda.gov/medwatch.||
1184|091|S|   In Canada - Call your doctor for medical advice about side||
1184|092|S|effects. You may report side effects to Health Canada at||
1184|093|S|1-866-234-2345.||
1184|094|B|||
1184|095|P|PRECAUTIONS:  Before taking lacosamide, tell your doctor or||
1184|096|P|pharmacist if you are allergic to it; or if you have any other||
1184|097|P|allergies. This product may contain inactive ingredients (such as||
1184|098|P|propylene glycol), which can cause allergic reactions or other||
1184|099|P|problems. Talk to your pharmacist for more details.||
1184|100|P|   Before using this medication, tell your doctor or pharmacist||
1184|101|P|your medical history, especially of: heart problems (such as||
1184|102|P|chest pain, sick sinus syndrome, heart failure, AV block,||
1184|103|P|irregular heartbeat), liver problems, kidney problems (including||
1184|104|P|dialysis treatment), mental/mood problems (such as depression,||
1184|105|P|psychosis), personal or family history of a substance use||
1184|106|P|disorder (such as overuse of or addiction to drugs/alcohol).||
1184|107|P|   This drug may make you dizzy or drowsy or cause blurred||
1184|108|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
1184|109|P|or drowsy. Do not drive, use machinery, or do anything that needs||
1184|110|P|alertness or clear vision until you can do it safely. Avoid||
1184|111|P|alcoholic beverages. Talk to your doctor if you are using||
1184|112|P|marijuana (cannabis).||
1184|113|P|   The liquid form of this medication may contain aspartame. If||
1184|114|P|you have phenylketonuria (PKU) or any other condition that||
1184|115|P|requires you to limit/avoid aspartame (or phenylalanine) in your||
1184|116|P|diet, ask your doctor or pharmacist about using this medication||
1184|117|P|safely.||
1184|118|P|   Before having surgery, tell your doctors or dentist about all||
1184|119|P|the products you use (including prescription drugs,||
1184|120|P|nonprescription drugs, and herbal products).||
1184|121|P|   During pregnancy, this medication should be used only when||
1184|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
1184|123|P|   This drug passes into breast milk and may have undesirable||
1184|124|P|effects on a nursing infant. Consult your doctor before||
1184|125|P|breastfeeding.||
1184|126|B|||
1184|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1184|128|I|medications work or increase your risk for serious side effects.||
1184|129|I|This document does not contain all possible drug interactions.||
1184|130|I|Keep a list of all the products you use (including||
1184|131|I|prescription/nonprescription drugs and herbal products) and share||
1184|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
1184|133|I|the dosage of any medicines without your doctor's approval.||
1184|134|I|   A product that may interact with this drug is: orlistat.||
1184|135|I|   Tell your doctor or pharmacist if you are using other products||
1184|136|I|that cause drowsiness such as opioid pain or cough relievers||
1184|137|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
1184|138|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
1184|139|I|zolpidem), muscle relaxants (such as carisoprodol,||
1184|140|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1184|141|I|diphenhydramine).||
1184|142|I|   Check the labels on all your medicines (such as allergy or||
1184|143|I|cough-and-cold products) because they may contain ingredients||
1184|144|I|that cause drowsiness. Ask your pharmacist about using those||
1184|145|I|products safely.||
1184|146|B|||
1184|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1184|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1184|149|O|poison control center right away. US residents can call||
1184|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1184|151|O|Symptoms of overdose may include: severe nausea/vomiting,||
1184|152|O|difficulty waking up, confusion, irregular heartbeat, very slow||
1184|153|O|breathing.||
1184|154|B|||
1184|155|N|NOTES:  Do not share this medication with others. Sharing it is||
1184|156|N|against the law.||
1184|157|N|   Lab and/or medical tests (such as liver/kidney function, EKG)||
1184|158|N|may be done while you are taking this medication. Keep all||
1184|159|N|medical and lab appointments. Consult your doctor for more||
1184|160|N|details.||
1184|161|B|||
1184|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1184|163|D|remember. If it is near the time of the next dose, skip the||
1184|164|D|missed dose. Take your next dose at the regular time. Do not||
1184|165|D|double the dose to catch up.||
1184|166|B|||
1184|167|R|STORAGE:  Store at room temperature away from light and moisture.||
1184|168|R|Do not store in the bathroom. Do not freeze the liquid form of||
1184|169|R|this medication. Once the bottle for the liquid form is opened,||
1184|170|R|the medication expires after 6 months. Keep all medications away||
1184|171|R|from children and pets.||
1184|172|R|   Do not flush medications down the toilet or pour them into a||
1184|173|R|drain unless instructed to do so. Properly discard this product||
1184|174|R|when it is expired or no longer needed. Consult your pharmacist||
1184|175|R|or local waste disposal company.||
1184|176|B|||
1184|177|M|MEDICAL ALERT:  Your condition can cause complications in a||
1184|178|M|medical emergency. For information about enrolling in MedicAlert,||
1184|179|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1184|180|B|||
1184|181|A|Information last revised November 2024.||
1184|182|A|Copyright(c) 2025 First Databank, Inc.||
1184|183|B|||
1185|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1185|002|Z|does NOT have all possible information about this product. This||
1185|003|Z|information does not assure that this product is safe, effective,||
1185|004|Z|or appropriate for you. This information is not individual||
1185|005|Z|medical advice and does not substitute for the advice of your||
1185|006|Z|health care professional. Always ask your health care||
1185|007|Z|professional for complete information about this product and your||
1185|008|Z|specific health needs.||
1185|009|B|||
1185|010|T|FLUOCINOLONE ACETONIDE - SHAMPOO||
1185|011|F|(FLOO-oh-SIN-oh-lone uh-SEET-oh-nide)||
1185|012|B|||
1185|013|C|COMMON BRAND NAME(S): Capex, FS Shampoo||
1185|014|B|||
1185|015|U|USES:  This shampoo is used to treat severe dandruff (seborrheic||
1185|016|U|dermatitis). Fluocinolone reduces the swelling, itching, flaking,||
1185|017|U|and redness that can occur with dandruff. This medication is a||
1185|018|U|low- to medium-strength corticosteroid.||
1185|019|B|||
1185|020|H|HOW TO USE:  This shampoo comes with a capsule of medication that||
1185|021|H|the pharmacist must add to the shampoo before giving you this||
1185|022|H|product. Once prepared, shake well before each use. Apply about||
1185|023|H|one ounce of the shampoo to the scalp once daily by working into||
1185|024|H|a lather. Allow it to remain on the scalp for 5 minutes. Then||
1185|025|H|thoroughly rinse your scalp and hair two times. Also rinse any||
1185|026|H|other body parts (such as hands, face, neck, shoulders) that may||
1185|027|H|have come in contact with the shampoo.||
1185|028|H|   Do not bandage, wrap or cover the affected area (such as avoid||
1185|029|H|using shower caps or bathing caps) unless directed by your||
1185|030|H|doctor.||
1185|031|H|   This shampoo should be used only on the scalp. Do not apply||
1185|032|H|this medication to your face, neck, groin, or underarms. After||
1185|033|H|applying the medication, wash your hands. Avoid getting this||
1185|034|H|medication in the eyes, nose, or mouth. If you get the medication||
1185|035|H|in these areas, rinse with plenty of water.||
1185|036|H|   Do not use this medication more often or for a longer period||
1185|037|H|than prescribed because the risk of side effects may be||
1185|038|H|increased. Tell your doctor if your condition lasts or gets worse||
1185|039|H|after 2 weeks.||
1185|040|B|||
1185|041|S|SIDE EFFECTS:  Burning, stinging, irritation, dryness, or redness||
1185|042|S|may occur when this medication is first applied to the scalp.||
1185|043|S|Acne, excessive hair growth, small red bumps on the skin||
1185|044|S|(folliculitis), skin thinning/discoloration, or stretch marks may||
1185|045|S|also occur. If any of these effects last or get worse, notify||
1185|046|S|your doctor or pharmacist promptly.||
1185|047|S|   Remember that this medication has been prescribed because your||
1185|048|S|doctor has judged that the benefit to you is greater than the||
1185|049|S|risk of side effects. Many people using this medication do not||
1185|050|S|have serious side effects.||
1185|051|S|   Rarely, it is possible this medication will be absorbed from||
1185|052|S|the skin into the bloodstream. This can lead to side effects of||
1185|053|S|too much corticosteroid. These side effects are more likely in||
1185|054|S|children, and in people who use this medication for a long time||
1185|055|S|or over large areas of the skin. Tell your doctor right away if||
1185|056|S|any of the following side effects occur: unusual/extreme||
1185|057|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
1185|058|S|thirst/urination, vision problems.||
1185|059|S|   A very serious allergic reaction to this drug is rare.||
1185|060|S|However, get medical help right away if you notice any symptoms||
1185|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1185|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1185|063|S|breathing.||
1185|064|S|   This is not a complete list of possible side effects. If you||
1185|065|S|notice other effects not listed above, contact your doctor or||
1185|066|S|pharmacist.||
1185|067|S|   In the US -||
1185|068|S|   Call your doctor for medical advice about side effects. You||
1185|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1185|070|S|www.fda.gov/medwatch.||
1185|071|S|   In Canada - Call your doctor for medical advice about side||
1185|072|S|effects. You may report side effects to Health Canada at||
1185|073|S|1-866-234-2345.||
1185|074|B|||
1185|075|P|PRECAUTIONS:  Before using fluocinolone, tell your doctor or||
1185|076|P|pharmacist if you are allergic to it; or to other corticosteroids||
1185|077|P|(such as prednisone, triamcinolone); or if you have any other||
1185|078|P|allergies. This product may contain inactive ingredients, which||
1185|079|P|can cause allergic reactions or other problems. Talk to your||
1185|080|P|pharmacist for more details.||
1185|081|P|   Before using this medication, tell your doctor or pharmacist||
1185|082|P|your medical history, especially of: other skin/scalp conditions||
1185|083|P|(such as rosacea, perioral dermatitis).||
1185|084|P|   Do not use if there is an infection or sore in the area to be||
1185|085|P|treated. Skin infections can become worse when using this||
1185|086|P|medication. Notify your doctor if redness, swelling or irritation||
1185|087|P|does not improve.||
1185|088|P|   Rarely, using corticosteroid medications for a long time or||
1185|089|P|over large areas of skin can make it more difficult for your body||
1185|090|P|to respond to physical stress. Before having surgery or emergency||
1185|091|P|treatment, or if you get a serious illness/injury, tell your||
1185|092|P|doctor or dentist that you are using this medication or have used||
1185|093|P|this medication within the past few months.||
1185|094|P|   Though it is unlikely, this medication may temporarily slow||
1185|095|P|down a child's growth if used for a long time. See the doctor||
1185|096|P|regularly so your child's height can be checked.||
1185|097|P|   During pregnancy, this medication should be used only when||
1185|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
1185|099|P|   It is unknown if this drug passes into breast milk when||
1185|100|P|applied to the skin. Similar medications pass into breast milk||
1185|101|P|when taken by mouth. Consult your doctor before breastfeeding.||
1185|102|B|||
1185|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1185|104|I|medications work or increase your risk for serious side effects.||
1185|105|I|This document does not contain all possible drug interactions.||
1185|106|I|Keep a list of all the products you use (including||
1185|107|I|prescription/nonprescription drugs and herbal products) and share||
1185|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
1185|109|I|the dosage of any medicines without your doctor's approval.||
1185|110|B|||
1185|111|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1185|112|O|has overdosed and has serious symptoms such as passing out or||
1185|113|O|trouble breathing, call 911. Otherwise, call a poison control||
1185|114|O|center right away. US residents can call 1-800-222-1222. Canada||
1185|115|O|residents can call 1-844-764-7669.||
1185|116|B|||
1185|117|N|NOTES:  Do not share this medication with others. This medication||
1185|118|N|has been prescribed for your current condition only. Do not use||
1185|119|N|it later for other skin problems unless told to do so by your||
1185|120|N|doctor. A different medication may be necessary in those cases.||
1185|121|N|   Lab and/or medical tests (such as adrenal gland function) may||
1185|122|N|be done while you are using this medication, especially if you||
1185|123|N|use this drug for an extended period of time or apply it over||
1185|124|N|large areas of the body. Keep all medical and lab appointments.||
1185|125|N|Consult your doctor for more details.||
1185|126|B|||
1185|127|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1185|128|D|next dose at the regular time. Do not double the dose to catch||
1185|129|D|up.||
1185|130|B|||
1185|131|R|STORAGE:  Store at room temperature. Avoid freezing. Keep all||
1185|132|R|medications away from children and pets. Discard after 2 months.||
1185|133|R|   Do not flush medications down the toilet or pour them into a||
1185|134|R|drain unless instructed to do so. Properly discard this product||
1185|135|R|when it is expired or no longer needed. Consult your pharmacist||
1185|136|R|or local waste disposal company.||
1185|137|B|||
1185|138|A|Information last revised October 2024.||
1185|139|A|Copyright(c) 2025 First Databank, Inc.||
1185|140|B|||
1187|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1187|002|Z|does NOT have all possible information about this product. This||
1187|003|Z|information does not assure that this product is safe, effective,||
1187|004|Z|or appropriate for you. This information is not individual||
1187|005|Z|medical advice and does not substitute for the advice of your||
1187|006|Z|health care professional. Always ask your health care||
1187|007|Z|professional for complete information about this product and your||
1187|008|Z|specific health needs.||
1187|009|B|||
1187|010|T|ZINC ACETATE - ORAL||
1187|011|F|(zink AS-e-tate)||
1187|012|B|||
1187|013|C|COMMON BRAND NAME(S): Galzin||
1187|014|B|||
1187|015|U|USES:  This medication is used after other medications to treat a||
1187|016|U|certain liver disease (Wilson's disease). This inherited disease||
1187|017|U|causes the liver to hold onto too much copper, resulting in liver||
1187|018|U|damage and other serious problems. This medication causes the||
1187|019|U|intestines to make more of a certain substance (a protein) that||
1187|020|U|prevents the body from absorbing too much copper from food,||
1187|021|U|thereby preventing further damage.||
1187|022|B|||
1187|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
1187|024|H|doctor, usually 3 times daily. Take each dose on an empty||
1187|025|H|stomach, at least 1 hour before or 2 to 3 hours after meals.||
1187|026|H|Swallow the capsule whole. Do not crush or chew the capsules.||
1187|027|H|   The dosage is based on your medical condition and response to||
1187|028|H|treatment.||
1187|029|H|   Use this medication regularly to get the most benefit from it.||
1187|030|H|To help you remember, take it at the same times each day.||
1187|031|H|   Tell your doctor if your condition does not get better or if||
1187|032|H|it gets worse.||
1187|033|B|||
1187|034|S|SIDE EFFECTS:  Upset stomach may occur. If this effect lasts or||
1187|035|S|gets worse, tell your doctor or pharmacist promptly.||
1187|036|S|   Remember that this medication has been prescribed because your||
1187|037|S|doctor has judged that the benefit to you is greater than the||
1187|038|S|risk of side effects. Many people using this medication do not||
1187|039|S|have serious side effects.||
1187|040|S|   Tell your doctor right away if you have any serious side||
1187|041|S|effects, including: unusual tiredness, easy bleeding/bruising,||
1187|042|S|signs of infection (such as sore throat that doesn't go away,||
1187|043|S|fever, chills), difficulty walking, severe stomach/abdominal||
1187|044|S|pain.||
1187|045|S|   A very serious allergic reaction to this drug is rare.||
1187|046|S|However, get medical help right away if you notice any symptoms||
1187|047|S|of a serious allergic reaction, including: rash, itching/swelling||
1187|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1187|049|S|breathing.||
1187|050|S|   This is not a complete list of possible side effects. If you||
1187|051|S|notice other effects not listed above, contact your doctor or||
1187|052|S|pharmacist.||
1187|053|S|   In the US -||
1187|054|S|   Call your doctor for medical advice about side effects. You||
1187|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1187|056|S|www.fda.gov/medwatch.||
1187|057|S|   In Canada - Call your doctor for medical advice about side||
1187|058|S|effects. You may report side effects to Health Canada at||
1187|059|S|1-866-234-2345.||
1187|060|B|||
1187|061|P|PRECAUTIONS:  Before taking zinc acetate, tell your doctor or||
1187|062|P|pharmacist if you are allergic to it; or if you have any other||
1187|063|P|allergies. This product may contain inactive ingredients, which||
1187|064|P|can cause allergic reactions or other problems. Talk to your||
1187|065|P|pharmacist for more details.||
1187|066|P|   Before using this medication, tell your doctor or pharmacist||
1187|067|P|your medical history.||
1187|068|P|   Before having surgery, tell your doctor or dentist about all||
1187|069|P|the products you use (including prescription drugs,||
1187|070|P|nonprescription drugs, and herbal products).||
1187|071|P|   Tell your doctor if you are pregnant before using this||
1187|072|P|medication.||
1187|073|P|   This drug passes into breast milk. Consult your doctor before||
1187|074|P|breastfeeding.||
1187|075|B|||
1187|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1187|077|I|medications work or increase your risk for serious side effects.||
1187|078|I|This document does not contain all possible drug interactions.||
1187|079|I|Keep a list of all the products you use (including||
1187|080|I|prescription/nonprescription drugs and herbal products) and share||
1187|081|I|it with your doctor and pharmacist. Do not start, stop, or change||
1187|082|I|the dosage of any medicines without your doctor's approval.||
1187|083|I|   This product can decrease the absorption of certain drugs,||
1187|084|I|especially if you take them around the same time. These drugs||
1187|085|I|include bisphosphonates (such as alendronate), penicillamine,||
1187|086|I|quinolone antibiotics (such as ciprofloxacin, levofloxacin),||
1187|087|I|tetracycline antibiotics (such as doxycycline, minocycline),||
1187|088|I|thyroid medications (such as levothyroxine), among others. Ask||
1187|089|I|your doctor or pharmacist how long you should wait between doses||
1187|090|I|of this product and your other medications and to find a dosing||
1187|091|I|schedule that works for all your medications.||
1187|092|B|||
1187|093|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1187|094|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1187|095|O|poison control center right away. US residents can call||
1187|096|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1187|097|O|Symptoms of overdose may include: nausea, vomiting,||
1187|098|O|stomach/abdominal pain, mental changes, decrease in urine||
1187|099|O|production.||
1187|100|B|||
1187|101|N|NOTES:  Do not share this medication with others.||
1187|102|N|   Lab and/or medical tests (such as 24-hour urine copper level,||
1187|103|N|liver function, speech evaluation) should be done while you are||
1187|104|N|taking this medication. Keep all medical and lab appointments.||
1187|105|N|Consult your doctor for more details.||
1187|106|B|||
1187|107|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1187|108|D|remember. If it is near the time of the next dose, skip the||
1187|109|D|missed dose. Take your next dose at the regular time. Do not||
1187|110|D|double the dose to catch up.||
1187|111|B|||
1187|112|R|STORAGE:  Store at room temperature away from light and moisture.||
1187|113|R|Do not store in the bathroom. Keep all medications away from||
1187|114|R|children and pets.||
1187|115|R|   Do not flush medications down the toilet or pour them into a||
1187|116|R|drain unless instructed to do so. Properly discard this product||
1187|117|R|when it is expired or no longer needed. Consult your pharmacist||
1187|118|R|or local waste disposal company.||
1187|119|B|||
1187|120|A|Information last revised October 2025.||
1187|121|A|Copyright(c) 2025 First Databank, Inc.||
1187|122|B|||
1188|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1188|002|Z|does NOT have all possible information about this product. This||
1188|003|Z|information does not assure that this product is safe, effective,||
1188|004|Z|or appropriate for you. This information is not individual||
1188|005|Z|medical advice and does not substitute for the advice of your||
1188|006|Z|health care professional. Always ask your health care||
1188|007|Z|professional for complete information about this product and your||
1188|008|Z|specific health needs.||
1188|009|B|||
1188|010|T|DEGARELIX - INJECTION||
1188|011|F|(DEG-a-REL-ix)||
1188|012|B|||
1188|013|C|COMMON BRAND NAME(S): Firmagon||
1188|014|B|||
1188|015|U|USES:  Degarelix is used to treat advanced prostate cancer in||
1188|016|U|men. It is not a cure. Most types of prostate cancer need the||
1188|017|U|hormone testosterone to grow and spread. Degarelix works by||
1188|018|U|reducing the amount of testosterone that the body makes. This||
1188|019|U|helps slow or stop the growth of cancer cells.||
1188|020|B|||
1188|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1188|022|H|from your pharmacist before you start using degarelix and each||
1188|023|H|time you get a refill. If you have any questions, ask your doctor||
1188|024|H|or pharmacist.||
1188|025|H|   This medication is given by injection under the skin by a||
1188|026|H|health care professional. It is given as directed by your doctor,||
1188|027|H|usually once a month. The injection is given in the abdomen.||
1188|028|H|   The first dose is given as two injections. The following||
1188|029|H|monthly doses are given as one injection. Make sure your||
1188|030|H|injection site is free of any pressure from belts, waistbands, or||
1188|031|H|other types of clothing. The injection site should not be close||
1188|032|H|to the ribs and should be changed each time to lessen discomfort||
1188|033|H|after the injection.||
1188|034|H|   Use this medication regularly to get the most benefit from it.||
1188|035|H|To help you remember, mark your calendar with a reminder.||
1188|036|B|||
1188|037|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site, hot||
1188|038|S|flashes (flushing), increased sweating, night sweats, back/joint||
1188|039|S|pain, chills, weight changes, tiredness, fever, and dizziness may||
1188|040|S|occur. If any of these effects last or get worse, tell your||
1188|041|S|doctor or pharmacist promptly.||
1188|042|S|   Rarely, shrinking of the testicles, breast||
1188|043|S|tenderness/swelling, and reduced sexual interest/ability may also||
1188|044|S|occur as a result of lowered testosterone levels. Talk to your||
1188|045|S|doctor if these effects occur.||
1188|046|S|   Remember that this medication has been prescribed because your||
1188|047|S|doctor has judged that the benefit to you is greater than the||
1188|048|S|risk of side effects. Many people using this medication do not||
1188|049|S|have serious side effects.||
1188|050|S|   Tell your doctor right away if you have any serious side||
1188|051|S|effects, including: nausea/vomiting that doesn't stop, loss of||
1188|052|S|appetite, dark urine, stomach/abdominal pain, yellowing||
1188|053|S|eyes/skin.||
1188|054|S|   Get medical help right away if you have any very serious side||
1188|055|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1188|056|S|fainting.||
1188|057|S|   A very serious allergic reaction to this drug is rare.||
1188|058|S|However, get medical help right away if you notice any symptoms||
1188|059|S|of a serious allergic reaction, including: rash, itching/swelling||
1188|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1188|061|S|breathing.||
1188|062|S|   This is not a complete list of possible side effects. If you||
1188|063|S|notice other effects not listed above, contact your doctor or||
1188|064|S|pharmacist.||
1188|065|S|   In the US -||
1188|066|S|   Call your doctor for medical advice about side effects. You||
1188|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1188|068|S|www.fda.gov/medwatch.||
1188|069|S|   In Canada - Call your doctor for medical advice about side||
1188|070|S|effects. You may report side effects to Health Canada at||
1188|071|S|1-866-234-2345.||
1188|072|B|||
1188|073|P|PRECAUTIONS:  Before using degarelix, tell your doctor or||
1188|074|P|pharmacist if you are allergic to it; or if you have any other||
1188|075|P|allergies. This product may contain inactive ingredients, which||
1188|076|P|can cause allergic reactions or other problems. Talk to your||
1188|077|P|pharmacist for more details.||
1188|078|P|   Before using this medication, tell your doctor or pharmacist||
1188|079|P|your medical history, especially of: kidney problems, liver||
1188|080|P|problems.||
1188|081|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1188|082|P|can make you more dizzy. Do not drive, use machinery, or do||
1188|083|P|anything that needs alertness until you can do it safely. Limit||
1188|084|P|alcoholic beverages. Talk to your doctor if you are using||
1188|085|P|marijuana (cannabis).||
1188|086|P|   Long term use of degarelix may cause a condition that affects||
1188|087|P|the heart rhythm (QT prolongation). QT prolongation can rarely||
1188|088|P|cause serious (rarely fatal) fast/irregular heartbeat and other||
1188|089|P|symptoms (such as severe dizziness, fainting) that need medical||
1188|090|P|attention right away.||
1188|091|P|   The risk of QT prolongation may be increased if you have||
1188|092|P|certain medical conditions or are taking other drugs that may||
1188|093|P|cause QT prolongation. Before using degarelix, tell your doctor||
1188|094|P|or pharmacist of all the drugs you take and if you have any of||
1188|095|P|the following conditions: certain heart problems (heart failure,||
1188|096|P|slow heartbeat, QT prolongation in the EKG), family history of||
1188|097|P|certain heart problems (QT prolongation in the EKG, sudden||
1188|098|P|cardiac death).||
1188|099|P|   Low levels of potassium or magnesium in the blood may also||
1188|100|P|increase your risk of QT prolongation. This risk may increase if||
1188|101|P|you use certain drugs (such as diuretics/"water pills") or if you||
1188|102|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1188|103|P|Talk to your doctor about using degarelix safely.||
1188|104|P|   Degarelix may weaken your bones and increase your risk for||
1188|105|P|bone loss (osteoporosis) if used for a long time. Consult your||
1188|106|P|doctor or pharmacist for details.||
1188|107|P|   Before having surgery, tell your doctor or dentist about all||
1188|108|P|the products you use (including prescription drugs,||
1188|109|P|nonprescription drugs, and herbal products).||
1188|110|P|   Older adults may be more sensitive to the side effects of this||
1188|111|P|drug, especially QT prolongation (see above).||
1188|112|P|   This medication can affect fertility in both males and||
1188|113|P|females. Ask your doctor for more details.||
1188|114|P|   This medication is not usually used in women and must not be||
1188|115|P|used during pregnancy. It may harm an unborn baby. If you become||
1188|116|P|pregnant or think you may be pregnant, tell your doctor right||
1188|117|P|away.||
1188|118|P|   It is unknown if degarelix passes into breast milk. Consult||
1188|119|P|your doctor before breastfeeding.||
1188|120|B|||
1188|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1188|122|I|medications work or increase your risk for serious side effects.||
1188|123|I|This document does not contain all possible drug interactions.||
1188|124|I|Keep a list of all the products you use (including||
1188|125|I|prescription/nonprescription drugs and herbal products) and share||
1188|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
1188|127|I|the dosage of any medicines without your doctor's approval.||
1188|128|I|   Many drugs besides degarelix may affect the heart rhythm (QT||
1188|129|I|prolongation), including amiodarone, dofetilide, pimozide,||
1188|130|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
1188|131|I|erythromycin), among others.||
1188|132|I|   This medication may interfere with certain lab tests (such as||
1188|133|I|pituitary gonadal function), possibly causing false test results.||
1188|134|I|Make sure lab personnel and all your doctors know you use this||
1188|135|I|drug.||
1188|136|B|||
1188|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1188|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1188|139|O|poison control center right away. US residents can call||
1188|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1188|141|B|||
1188|142|N|NOTES:  Lab and/or medical tests (such as blood testosterone||
1188|143|N|level, PSA blood test) should be done while you are using this||
1188|144|N|medication. Keep all medical and lab appointments. Consult your||
1188|145|N|doctor for more details.||
1188|146|B|||
1188|147|D|MISSED DOSE:  It is important to get each dose of this medication||
1188|148|D|as scheduled. If you miss a dose, ask your doctor right away for||
1188|149|D|a new dosing schedule.||
1188|150|B|||
1188|151|R|STORAGE:  Not applicable. This medication is given in a clinic||
1188|152|R|and will not be stored at home.||
1188|153|B|||
1188|154|A|Information last revised October 2024.||
1188|155|A|Copyright(c) 2025 First Databank, Inc.||
1188|156|B|||
1189|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1189|002|Z|does NOT have all possible information about this product. This||
1189|003|Z|information does not assure that this product is safe, effective,||
1189|004|Z|or appropriate for you. This information is not individual||
1189|005|Z|medical advice and does not substitute for the advice of your||
1189|006|Z|health care professional. Always ask your health care||
1189|007|Z|professional for complete information about this product and your||
1189|008|Z|specific health needs.||
1189|009|B|||
1189|010|T|TEMOZOLOMIDE - INJECTION||
1189|011|F|(TEM-oh-ZOL-oh-mide)||
1189|012|B|||
1189|013|C|COMMON BRAND NAME(S): Temodar||
1189|014|B|||
1189|015|U|USES:  This medication is used to treat certain types of brain||
1189|016|U|cancer. Temozolomide belongs to a class of drugs known as||
1189|017|U|alkylating agents. It works by slowing or stopping the growth of||
1189|018|U|cancer cells.||
1189|019|B|||
1189|020|V|OTHER USES:  This section contains uses of this drug that are not||
1189|021|V|listed in the approved professional labeling for the drug but||
1189|022|V|that may be prescribed by your health care professional. Use this||
1189|023|V|drug for a condition that is listed in this section only if it||
1189|024|V|has been so prescribed by your health care professional.||
1189|025|V|   This drug may also be used for other types of cancer (such as||
1189|026|V|bone cancer).||
1189|027|B|||
1189|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1189|029|H|from your pharmacist before you start using temozolomide and each||
1189|030|H|time you get a refill. If you have any questions, ask your doctor||
1189|031|H|or pharmacist.||
1189|032|H|   This medication is given by injection into a vein as directed||
1189|033|H|by your doctor. It is given by a health care professional,||
1189|034|H|usually over 90 minutes.||
1189|035|H|   The dosage and treatment schedule are based on your medical||
1189|036|H|condition, height, weight, and response to treatment. To get the||
1189|037|H|most benefit, carefully follow the dosing schedule as directed by||
1189|038|H|your doctor. To help you remember, mark your calendar with a||
1189|039|H|reminder.||
1189|040|H|   Your doctor may also prescribe other medications (such as||
1189|041|H|antibiotics) to help prevent infection or side effects. Follow||
1189|042|H|your doctor's directions for taking all your medications.||
1189|043|B|||
1189|044|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, mouth sores,||
1189|045|S|changes in taste, constipation, tiredness, dizziness, trouble||
1189|046|S|sleeping, headache, or pain/redness/swelling at the injection||
1189|047|S|site may occur. Nausea and vomiting can be severe. In some cases,||
1189|048|S|your doctor may prescribe medication to prevent or relieve nausea||
1189|049|S|and vomiting. Eating several small meals, not eating before||
1189|050|S|treatment, or limiting activity may help lessen some of these||
1189|051|S|effects. If any of these effects last or get worse, tell your||
1189|052|S|doctor or pharmacist promptly.||
1189|053|S|   Temporary hair loss may occur. Normal hair growth should||
1189|054|S|return after treatment has ended.||
1189|055|S|   People using this medication may have serious side effects.||
1189|056|S|However, you have been prescribed this drug because your doctor||
1189|057|S|has judged that the benefit to you is greater than the risk of||
1189|058|S|side effects. Careful monitoring by your doctor may decrease your||
1189|059|S|risk.||
1189|060|S|   Although temozolomide is used to treat cancer, it may rarely||
1189|061|S|increase your risk of getting other cancers. Also, temozolomide||
1189|062|S|decreases bone marrow function, an effect that may lead to a low||
1189|063|S|number of blood cells such as red cells, white cells, and||
1189|064|S|platelets. This effect can cause anemia, decrease your body's||
1189|065|S|ability to fight an infection, or cause easy bruising/bleeding.||
1189|066|S|Tell your doctor right away if you develop any of the following||
1189|067|S|symptoms: unusual tiredness, pale skin, signs of infection (such||
1189|068|S|as sore throat that doesn't go away, fever, chills), easy||
1189|069|S|bruising/bleeding.||
1189|070|S|   Tell your doctor right away if you have any serious side||
1189|071|S|effects, such as: symptoms of liver damage (such as||
1189|072|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1189|073|S|   Get medical help right away if you have any very serious side||
1189|074|S|effects, such as: seizure.||
1189|075|S|   A very serious allergic reaction to this drug is rare.||
1189|076|S|However, get medical help right away if you notice any symptoms||
1189|077|S|of a serious allergic reaction, such as: rash, itching/swelling||
1189|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1189|079|S|breathing.||
1189|080|S|   This is not a complete list of possible side effects. If you||
1189|081|S|notice other effects not listed above, contact your doctor or||
1189|082|S|pharmacist.||
1189|083|S|   In the US -||
1189|084|S|   Call your doctor for medical advice about side effects. You||
1189|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1189|086|S|www.fda.gov/medwatch.||
1189|087|S|   In Canada - Call your doctor for medical advice about side||
1189|088|S|effects. You may report side effects to Health Canada at||
1189|089|S|1-866-234-2345.||
1189|090|B|||
1189|091|P|PRECAUTIONS:  Before receiving temozolomide, tell your doctor or||
1189|092|P|pharmacist if you are allergic to it; or to dacarbazine; or if||
1189|093|P|you have any other allergies. This product may contain inactive||
1189|094|P|ingredients, which can cause allergic reactions or other||
1189|095|P|problems. Talk to your pharmacist for more details.||
1189|096|P|   Before using this medication, tell your doctor or pharmacist||
1189|097|P|your medical history, especially of: kidney problems, liver||
1189|098|P|problems, bleeding/blood problems.||
1189|099|P|   Temozolomide can make you more likely to get infections or may||
1189|100|P|make current infections worse. Stay away from anyone who has an||
1189|101|P|infection that may easily spread (such as chickenpox, COVID-19,||
1189|102|P|measles, flu). Talk to your doctor if you have been exposed to an||
1189|103|P|infection or for more details.||
1189|104|P|   Tell your health care professional that you are using||
1189|105|P|temozolomide before having any immunizations/vaccinations. Avoid||
1189|106|P|contact with people who have recently received live vaccines||
1189|107|P|(such as flu vaccine inhaled through the nose).||
1189|108|P|   To lower the chance of getting cut, bruised, or injured, use||
1189|109|P|caution with sharp objects like razors and nail cutters, and||
1189|110|P|avoid activities such as contact sports.||
1189|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1189|112|P|can make you more dizzy. Do not drive, use machinery, or do||
1189|113|P|anything that needs alertness until you can do it safely. Limit||
1189|114|P|alcoholic beverages. Talk to your doctor if you are using||
1189|115|P|marijuana (cannabis).||
1189|116|P|   Before having surgery, tell your doctor or dentist about all||
1189|117|P|the products you use (such as prescription drugs, nonprescription||
1189|118|P|drugs, and herbal products).||
1189|119|P|   Women and older adults may be more sensitive to the side||
1189|120|P|effects of this drug, especially increased risk of infection and||
1189|121|P|easy bruising/bleeding.||
1189|122|P|   Men should not donate sperm while using temozolomide and for 3||
1189|123|P|months after stopping this drug.||
1189|124|P|   Tell your doctor if you are pregnant or plan to become||
1189|125|P|pregnant. You should not become pregnant while using||
1189|126|P|temozolomide. Temozolomide may harm an unborn baby. Your doctor||
1189|127|P|should order a pregnancy test before you start this medication.||
1189|128|P|Women using this medication should ask about reliable forms of||
1189|129|P|birth control during treatment and for 6 months after the last||
1189|130|P|dose. Men using this medication who have a partner that is||
1189|131|P|pregnant or who can become pregnant should use condoms for birth||
1189|132|P|control during treatment and for some time after the last dose.||
1189|133|P|If you or your partner becomes pregnant, talk to your doctor||
1189|134|P|right away about the risks and benefits of this medication.||
1189|135|P|   It is unknown if this drug passes into breast milk. Because of||
1189|136|P|the possible risk to the infant, breastfeeding is not recommended||
1189|137|P|while using this drug and for 1 week after the last dose. Consult||
1189|138|P|your doctor before breastfeeding.||
1189|139|B|||
1189|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1189|141|I|medications work or increase your risk for serious side effects.||
1189|142|I|This document does not contain all possible drug interactions.||
1189|143|I|Keep a list of all the products you use (such as||
1189|144|I|prescription/nonprescription drugs and herbal products) and share||
1189|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
1189|146|I|the dosage of any medicines without your doctor's approval.||
1189|147|B|||
1189|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1189|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1189|150|O|poison control center right away. US residents can call||
1189|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1189|152|B|||
1189|153|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1189|154|N|liver function, brain scan) should be done before you start using||
1189|155|N|this medication and while you are using it. Keep all medical and||
1189|156|N|lab appointments.||
1189|157|B|||
1189|158|D|MISSED DOSE:  It is important to get each dose of this medication||
1189|159|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1189|160|D|right away for a new dosing schedule. Do not double the dose to||
1189|161|D|catch up.||
1189|162|B|||
1189|163|R|STORAGE:  Not applicable. This medication is given in a hospital||
1189|164|R|or clinic and will not be stored at home.||
1189|165|B|||
1189|166|M|MEDICAL ALERT:  Your condition can cause complications in a||
1189|167|M|medical emergency. For information about enrolling in MedicAlert,||
1189|168|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1189|169|B|||
1189|170|A|Information last revised October 2024.||
1189|171|A|Copyright(c) 2025 First Databank, Inc.||
1189|172|B|||
1190|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1190|002|Z|does NOT have all possible information about this product. This||
1190|003|Z|information does not assure that this product is safe, effective,||
1190|004|Z|or appropriate for you. This information is not individual||
1190|005|Z|medical advice and does not substitute for the advice of your||
1190|006|Z|health care professional. Always ask your health care||
1190|007|Z|professional for complete information about this product and your||
1190|008|Z|specific health needs.||
1190|009|B|||
1190|010|T|DIPHTHERIA/TETANUS/PERTUSSIS/HEP B/POLIO VACCINE - INJECTION||
1190|011|F|(dip-THEER-ee-uh/TET-un-us/per-TUSS-iss/hep-uh-TIE-tuss B/||
1190|012|F|POE-lee-oh)||
1190|013|B|||
1190|014|C|COMMON BRAND NAME(S): Pediarix||
1190|015|B|||
1190|016|U|USES:  This vaccine is used to help prevent diphtheria, tetanus||
1190|017|U|(lockjaw), pertussis (whooping cough), hepatitis B, and polio.||
1190|018|U|Vaccination is the best way to protect against these||
1190|019|U|life-threatening diseases. This vaccine works by increasing the||
1190|020|U|body's natural defense (immunity) against the bacteria/virus.||
1190|021|U|   This vaccine is usually given to children between 6 weeks and||
1190|022|U|7 years old.||
1190|023|U|   Vaccines may not fully protect everyone who receives them.||
1190|024|B|||
1190|025|H|HOW TO USE:  Read all vaccine information available from your||
1190|026|H|health care professional before receiving the vaccine. If you||
1190|027|H|have any questions, ask your health care professional.||
1190|028|H|   This vaccine is given by injection into a muscle by a health||
1190|029|H|care professional. It is given in the upper arm for children and||
1190|030|H|in the thigh for infants.||
1190|031|H|   Vaccines are usually given in a series of doses to provide the||
1190|032|H|best protection. Closely follow the vaccination schedule provided||
1190|033|H|by your health care professional. To help you remember, mark your||
1190|034|H|calendar with a reminder.||
1190|035|B|||
1190|036|S|SIDE EFFECTS:  Pain/swelling/redness at the injection site,||
1190|037|S|fever, fussiness, and loss of appetite may occur. If any of these||
1190|038|S|effects last or get worse, tell the health care professional||
1190|039|S|promptly.||
1190|040|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1190|041|S|vision changes, or ringing in the ears just after getting a||
1190|042|S|vaccine injection. Tell the health care professional right away||
1190|043|S|if your child has any of these symptoms. Sitting or lying down||
1190|044|S|may help, since these symptoms usually don't last long.||
1190|045|S|   Remember that this vaccine has been prescribed because the||
1190|046|S|health care professional has judged that the benefit to your||
1190|047|S|child is greater than the risk of side effects. Many people using||
1190|048|S|this vaccine do not have serious side effects.||
1190|049|S|   Tell your health care professional right away if your child||
1190|050|S|has any serious side effects, including: high fever (105 degrees||
1190|051|S|F/40 degrees C or higher), nonstop crying (beginning within 48||
1190|052|S|hours of the injection and lasting longer than 3 hours),||
1190|053|S|seizures, little or no response to sound/touch, weak/floppy||
1190|054|S|muscles, severe pain/swelling at the injection site.||
1190|055|S|   A very serious allergic reaction to this vaccine is rare.||
1190|056|S|However, get medical help right away if you notice any symptoms||
1190|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1190|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1190|059|S|breathing.||
1190|060|S|   This is not a complete list of possible side effects. If you||
1190|061|S|notice other effects not listed above, contact the health care||
1190|062|S|professional.||
1190|063|S|   Contact the health care professional for medical advice about||
1190|064|S|side effects. The following numbers do not provide medical||
1190|065|S|advice, but in the US you may report side effects to the Vaccine||
1190|066|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1190|067|S|Canada, you may call the Vaccine Safety Section at Public Health||
1190|068|S|Agency of Canada at 1-866-844-0018.||
1190|069|B|||
1190|070|P|PRECAUTIONS:  Before your child receives this vaccine, tell the||
1190|071|P|health care professional if your child is allergic to it; or if||
1190|072|P|your child has any other allergies. This product may contain||
1190|073|P|inactive ingredients (such as dry natural rubber/latex found in||
1190|074|P|the packaging of some products, yeast, neomycin, polymyxin B),||
1190|075|P|which can cause allergic reactions or other problems. Talk to||
1190|076|P|your health care professional for more details.||
1190|077|P|   Before receiving this vaccine, tell the health care||
1190|078|P|professional your child's medical history, especially of: current||
1190|079|P|fever/illness, nervous system disorders (such as seizures,||
1190|080|P|encephalopathy, Guillain-Barre syndrome), immune system disorders||
1190|081|P|(such as due to HIV infection, certain cancers such as||
1190|082|P|leukemia/lymphoma, cancer or radiation treatment), vaccination||
1190|083|P|history (including previous reactions to any vaccines).||
1190|084|P|   This vaccine is not usually used by adults. It is unlikely to||
1190|085|P|be used during pregnancy or breastfeeding. Consult the health||
1190|086|P|care professional if you have any questions about using this||
1190|087|P|vaccine.||
1190|088|B|||
1190|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1190|090|I|medications work or increase your risk for serious side effects.||
1190|091|I|This document does not contain all possible drug interactions.||
1190|092|I|Keep a list of all the products your child uses (including||
1190|093|I|prescription/nonprescription drugs and herbal products) and share||
1190|094|I|it with the health care professional. Do not start, stop, or||
1190|095|I|change the dosage of any medicines without the doctor's approval.||
1190|096|I|   Some products that may interact with this vaccine are: drugs||
1190|097|I|that weaken the immune system (including cyclosporine,||
1190|098|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1190|099|I|prednisone).||
1190|100|B|||
1190|101|O|OVERDOSE:  Not applicable.||
1190|102|B|||
1190|103|N|NOTES:  Keep all medical and lab appointments.||
1190|104|N|   Keep vaccine records for yourself and your children and||
1190|105|N|provide them to the health care professionals to prevent||
1190|106|N|unnecessary re-vaccinations.||
1190|107|B|||
1190|108|D|MISSED DOSE:  It is important that your child receives each||
1190|109|D|vaccination as scheduled. Ask when your child should get each||
1190|110|D|dose and mark your calendar with a reminder. If your child misses||
1190|111|D|a dose, call the health care professional to reschedule.||
1190|112|B|||
1190|113|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
1190|114|R|medications away from children and pets.||
1190|115|R|   Do not flush medications down the toilet or pour them into a||
1190|116|R|drain unless instructed to do so. Properly discard this product||
1190|117|R|when it is expired or no longer needed. Consult your pharmacist||
1190|118|R|or local waste disposal company.||
1190|119|B|||
1190|120|A|Information last revised February 2025.||
1190|121|A|Copyright(c) 2025 First Databank, Inc.||
1190|122|B|||
1191|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1191|002|Z|does NOT have all possible information about this product. This||
1191|003|Z|information does not assure that this product is safe, effective,||
1191|004|Z|or appropriate for you. This information is not individual||
1191|005|Z|medical advice and does not substitute for the advice of your||
1191|006|Z|health care professional. Always ask your health care||
1191|007|Z|professional for complete information about this product and your||
1191|008|Z|specific health needs.||
1191|009|B|||
1191|010|T|EVEROLIMUS - ORAL||
1191|011|F|(E-ver-OH-li-mus)||
1191|012|B|||
1191|013|C|COMMON BRAND NAME(S): Afinitor||
1191|014|B|||
1191|015|U|USES:  Everolimus is used to treat various types of cancer (such||
1191|016|U|as kidney, breast, pancreas, lung, stomach/intestinal cancers).||
1191|017|U|Everolimus is also used in people with a certain genetic disorder||
1191|018|U|(tuberous sclerosis complex) to treat certain types of benign||
1191|019|U|tumors in the brain or kidney. It works by slowing or stopping||
1191|020|U|the growth of cancer or tumor cells.||
1191|021|B|||
1191|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1191|023|H|from your pharmacist before you start taking everolimus and each||
1191|024|H|time you get a refill. If you have any questions, ask your doctor||
1191|025|H|or pharmacist.||
1191|026|H|   Do not change dosage forms of this medication without checking||
1191|027|H|with your doctor or pharmacist.||
1191|028|H|   Take this medication by mouth as directed by your doctor,||
1191|029|H|usually once daily. You may take this medication with or without||
1191|030|H|food, but it is important to choose one way and take this||
1191|031|H|medication the same way with every dose. Swallow this medication||
1191|032|H|whole with a glass of water. Do not crush or chew the tablets.||
1191|033|H|   The dosage is based on your medical condition, response to||
1191|034|H|treatment, lab tests, and other medications you may be taking. Be||
1191|035|H|sure to tell your doctor and pharmacist about all the products||
1191|036|H|you use (including prescription drugs, nonprescription drugs, and||
1191|037|H|herbal products). If you are taking this medication to treat a||
1191|038|H|certain type of benign brain tumor, the dosage is also based on||
1191|039|H|body size.||
1191|040|H|   Use this medication regularly to get the most benefit from it.||
1191|041|H|To help you remember, take it at the same time each day.||
1191|042|H|   Do not increase your dose or use this drug more often or for||
1191|043|H|longer than prescribed. Your condition will not improve any||
1191|044|H|faster, and your risk of serious side effects will increase.||
1191|045|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1191|046|H|using this medication unless your doctor or pharmacist says you||
1191|047|H|may do so safely. Grapefruit can increase the chance of side||
1191|048|H|effects with this medicine. Ask your doctor or pharmacist for||
1191|049|H|more details.||
1191|050|H|   Since this drug can be absorbed through the skin and lungs and||
1191|051|H|may harm an unborn baby, women who are pregnant or who may become||
1191|052|H|pregnant should not handle this medication or breathe the dust||
1191|053|H|from the tablets.||
1191|054|B|||
1191|055|S|SIDE EFFECTS:  Diarrhea, nausea/vomiting, decreased appetite,||
1191|056|S|weight loss, changes in taste, nosebleeds, dry skin, dizziness,||
1191|057|S|and headache may occur. If any of these effects last or get||
1191|058|S|worse, tell your doctor or pharmacist promptly.||
1191|059|S|   Pain or sores in the mouth and throat may occur. To reduce the||
1191|060|S|risk of getting mouth sores when you start everolimus treatment,||
1191|061|S|your doctor may prescribe a mouthwash that contains a||
1191|062|S|corticosteroid medication. Brush your teeth carefully/gently and||
1191|063|S|avoid using mouthwash that contains alcohol, iodine, peroxide, or||
1191|064|S|thyme. Rinse your mouth often with cool water mixed with baking||
1191|065|S|soda or salt. It may also be best to eat soft, moist foods.||
1191|066|S|   Temporary hair loss may occur. Normal hair growth should||
1191|067|S|return after treatment has ended.||
1191|068|S|   People using this medication may have serious side effects.||
1191|069|S|However, you have been prescribed this drug because your doctor||
1191|070|S|has judged that the benefit to you is greater than the risk of||
1191|071|S|side effects. Careful monitoring by your doctor may decrease your||
1191|072|S|risk.||
1191|073|S|   Tell your doctor right away if you have any serious side||
1191|074|S|effects, including: swelling hands/ankles/feet,||
1191|075|S|missed/heavy/painful periods, easy bruising/bleeding, unusual||
1191|076|S|tiredness, mental/mood changes, wound problems (such as slowed||
1191|077|S|wound healing).||
1191|078|S|   Everolimus has rarely caused very serious (possibly fatal)||
1191|079|S|kidney problems. Tell your doctor right away if you develop signs||
1191|080|S|of kidney problems, such as a change in the amount of urine.||
1191|081|S|   This medication may rarely make your blood sugar rise, which||
1191|082|S|can cause or worsen diabetes. Tell your doctor right away if you||
1191|083|S|have symptoms of high blood sugar such as increased||
1191|084|S|thirst/urination. If you already have diabetes, check your blood||
1191|085|S|sugar regularly as directed and share the results with your||
1191|086|S|doctor. Your doctor may need to adjust your diabetes medication,||
1191|087|S|exercise program, or diet.||
1191|088|S|   This medication may cause your cholesterol/triglycerides to||
1191|089|S|increase. You may need to have your cholesterol/triglycerides||
1191|090|S|checked periodically and/or take another medication to control||
1191|091|S|your cholesterol/triglycerides.||
1191|092|S|   Everolimus may lower your ability to fight infections. This||
1191|093|S|may make you more likely to get a serious (rarely fatal)||
1191|094|S|infection or make any infection you have worse. Tell your doctor||
1191|095|S|right away if you have any signs of infection (such as sore||
1191|096|S|throat that doesn't go away, fever, chills).||
1191|097|S|   This medication may make side effects from radiation treatment||
1191|098|S|worse. These side effects can sometimes be severe. Tell your||
1191|099|S|doctor if you have had or are planning to have radiation||
1191|100|S|treatment.||
1191|101|S|   This medication has caused very serious (rarely fatal) lung||
1191|102|S|problems. Get medical help right away if you have symptoms of||
1191|103|S|lung problems, such as shortness of breath, chest pain.||
1191|104|S|   Everolimus may rarely cause serious (possibly fatal) liver||
1191|105|S|disease in people who have hepatitis B virus. Get medical help||
1191|106|S|right away if you have any symptoms of liver damage, including:||
1191|107|S|nausea/vomiting that doesn't stop, loss of appetite, dark urine,||
1191|108|S|stomach/abdominal pain, yellow eyes/skin.||
1191|109|S|   This medication may increase your risk of getting a rare but||
1191|110|S|very serious (sometimes fatal) brain infection (progressive||
1191|111|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1191|112|S|if any of these rare but very serious side effects occur:||
1191|113|S|clumsiness, loss of coordination, weakness, sudden change in your||
1191|114|S|thinking (such as confusion, difficulty concentrating),||
1191|115|S|difficulty moving your muscles, problems with speech, seizure,||
1191|116|S|vision changes.||
1191|117|S|   Everolimus can commonly cause a mild rash that is usually not||
1191|118|S|serious. However, you may not be able to tell it apart from a||
1191|119|S|rare rash that could be a sign of a severe allergic reaction. Get||
1191|120|S|medical help right away if you develop any rash.||
1191|121|S|   A very serious allergic reaction to this drug is rare.||
1191|122|S|However, get medical help right away if you notice any symptoms||
1191|123|S|of a serious allergic reaction, including: rash, itching/swelling||
1191|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1191|125|S|breathing.||
1191|126|S|   This is not a complete list of possible side effects. If you||
1191|127|S|notice other effects not listed above, contact your doctor or||
1191|128|S|pharmacist.||
1191|129|S|   In the US -||
1191|130|S|   Call your doctor for medical advice about side effects. You||
1191|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1191|132|S|www.fda.gov/medwatch.||
1191|133|S|   In Canada - Call your doctor for medical advice about side||
1191|134|S|effects. You may report side effects to Health Canada at||
1191|135|S|1-866-234-2345.||
1191|136|B|||
1191|137|P|PRECAUTIONS:  Before taking everolimus, tell your doctor or||
1191|138|P|pharmacist if you are allergic to it; or to sirolimus or||
1191|139|P|temsirolimus; or if you have any other allergies. This product||
1191|140|P|may contain inactive ingredients, which can cause allergic||
1191|141|P|reactions or other problems. Talk to your pharmacist for more||
1191|142|P|details.||
1191|143|P|   Before using this medication, tell your doctor or pharmacist||
1191|144|P|your medical history, especially of: liver disease, any||
1191|145|P|recent/current infections, diabetes, high||
1191|146|P|cholesterol/triglyceride levels, radiation treatment.||
1191|147|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1191|148|P|can make you more dizzy. Do not drive, use machinery, or do||
1191|149|P|anything that needs alertness until you can do it safely. Limit||
1191|150|P|alcoholic beverages. Talk to your doctor if you are using||
1191|151|P|marijuana (cannabis).||
1191|152|P|   Everolimus can make you more likely to get infections or may||
1191|153|P|make current infections worse. Stay away from anyone who has an||
1191|154|P|infection that may easily spread (such as chickenpox, COVID-19,||
1191|155|P|measles, flu). Talk to your doctor if you have been exposed to an||
1191|156|P|infection or for more details.||
1191|157|P|   Tell your health care professional that you are using||
1191|158|P|everolimus before having any immunizations/vaccinations. Avoid||
1191|159|P|contact with people who have recently received live vaccines||
1191|160|P|(such as flu vaccine inhaled through the nose).||
1191|161|P|   To lower the chance of getting cut, bruised, or injured, use||
1191|162|P|caution with sharp objects like razors and nail cutters, and||
1191|163|P|avoid activities such as contact sports.||
1191|164|P|   Before having surgery, tell your doctor or dentist about all||
1191|165|P|the products you use (including prescription drugs,||
1191|166|P|nonprescription drugs, and herbal products). Your doctor or||
1191|167|P|dentist may tell you to stop taking everolimus at least 1 week||
1191|168|P|before surgery. This medication may cause wounds to heal more||
1191|169|P|slowly. Follow all instructions about when to stop or restart||
1191|170|P|this medication.||
1191|171|P|   Older adults may be more sensitive to the side effects of this||
1191|172|P|drug.||
1191|173|P|   This medication can affect fertility in both males and||
1191|174|P|females. Ask your doctor for more details.||
1191|175|P|   Tell your doctor if you are pregnant or plan to become||
1191|176|P|pregnant. You should not become pregnant while using everolimus.||
1191|177|P|Everolimus may harm an unborn baby. Women using this medication||
1191|178|P|should ask about reliable forms of birth control during treatment||
1191|179|P|and for 8 weeks after the last dose. Men using this medication||
1191|180|P|should ask about reliable forms of birth control during treatment||
1191|181|P|and for 4 weeks after the last dose. If you or your partner||
1191|182|P|becomes pregnant, talk to your doctor right away about the risks||
1191|183|P|and benefits of this medication.||
1191|184|P|   Since this drug can be absorbed through the skin and lungs and||
1191|185|P|may harm an unborn baby, women who are pregnant or who may become||
1191|186|P|pregnant should not handle this medication or breathe the dust||
1191|187|P|from the tablets.||
1191|188|P|   It is unknown if this medication passes into breast milk.||
1191|189|P|Because of the possible risk to the infant, breastfeeding is not||
1191|190|P|recommended while using this medication and for 2 weeks after the||
1191|191|P|last dose. Consult your doctor before breastfeeding.||
1191|192|B|||
1191|193|I|DRUG INTERACTIONS:  See also How to Use section.||
1191|194|I|   Drug interactions may change how your medications work or||
1191|195|I|increase your risk for serious side effects. This document does||
1191|196|I|not contain all possible drug interactions. Keep a list of all||
1191|197|I|the products you use (including prescription/nonprescription||
1191|198|I|drugs and herbal products) and share it with your doctor and||
1191|199|I|pharmacist. Do not start, stop, or change the dosage of any||
1191|200|I|medicines without your doctor's approval.||
1191|201|I|   Some products that may interact with this drug include: other||
1191|202|I|drugs that weaken the immune system/increase the risk of||
1191|203|I|infection (such as natalizumab, rituximab), ACE inhibitors (such||
1191|204|I|as captopril, lisinopril).||
1191|205|I|   Other medications can affect the removal of everolimus from||
1191|206|I|your body, which may affect how everolimus works. Examples||
1191|207|I|include azole antifungals (such as itraconazole, ketoconazole),||
1191|208|I|cobicistat, macrolide antibiotics (such as clarithromycin,||
1191|209|I|erythromycin), nefazodone, HIV protease inhibitors (such as||
1191|210|I|atazanavir), ritonavir, St. John's wort, telithromycin, among||
1191|211|I|others.||
1191|212|B|||
1191|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1191|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1191|215|O|poison control center right away. US residents can call||
1191|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1191|217|B|||
1191|218|N|NOTES:  Do not share this medication with others.||
1191|219|N|   Lab and/or medical tests (such as blood sugar,||
1191|220|N|cholesterol/triglyceride levels, complete blood count, kidney||
1191|221|N|function, everolimus trough levels) should be done before you||
1191|222|N|start taking this medication and while you are taking it. Keep||
1191|223|N|all medical and lab appointments. Consult your doctor for more||
1191|224|N|details.||
1191|225|B|||
1191|226|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1191|227|D|remember. If it is more than 6 hours after the missed dose, skip||
1191|228|D|the missed dose. Take your next dose at the regular time. Do not||
1191|229|D|double the dose to catch up.||
1191|230|B|||
1191|231|R|STORAGE:  Store in the original container at room temperature||
1191|232|R|away from light and moisture. Do not store in the bathroom. Keep||
1191|233|R|all medications away from children and pets.||
1191|234|R|   Do not flush medications down the toilet or pour them into a||
1191|235|R|drain unless instructed to do so. Properly discard this product||
1191|236|R|when it is expired or no longer needed. Consult your pharmacist||
1191|237|R|or local waste disposal company.||
1191|238|B|||
1191|239|M|MEDICAL ALERT:  Your condition can cause complications in a||
1191|240|M|medical emergency. For information about enrolling in MedicAlert,||
1191|241|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1191|242|B|||
1191|243|A|Information last revised April 2025.||
1191|244|A|Copyright(c) 2025 First Databank, Inc.||
1191|245|B|||
1192|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1192|002|Z|does NOT have all possible information about this product. This||
1192|003|Z|information does not assure that this product is safe, effective,||
1192|004|Z|or appropriate for you. This information is not individual||
1192|005|Z|medical advice and does not substitute for the advice of your||
1192|006|Z|health care professional. Always ask your health care||
1192|007|Z|professional for complete information about this product and your||
1192|008|Z|specific health needs.||
1192|009|B|||
1192|010|T|OXYBUTYNIN GEL - TRANSDERMAL||
1192|011|F|(OX-i-BUE-ti-nin)||
1192|012|B|||
1192|013|C|COMMON BRAND NAME(S): Gelnique||
1192|014|B|||
1192|015|U|USES:  This medication is used to treat an overactive bladder.||
1192|016|U|Oxybutynin improves your ability to control your urination by||
1192|017|U|relaxing the muscles in the bladder. It helps to reduce leaking||
1192|018|U|of urine, feelings of needing to urinate right away, and frequent||
1192|019|U|trips to the bathroom. This medication belongs to the class of||
1192|020|U|drugs known as antispasmodics.||
1192|021|B|||
1192|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1192|023|H|from your pharmacist before you start using oxybutynin and each||
1192|024|H|time you get a refill. If you have any questions, ask your doctor||
1192|025|H|or pharmacist.||
1192|026|H|   Wash your hands and the area of skin where the gel will be||
1192|027|H|applied with a mild soap and water. Allow the area to dry||
1192|028|H|completely before applying.||
1192|029|H|   Apply the gel from 1 packet (about the size of a nickel) to an||
1192|030|H|area of skin on the shoulders/upper arms, abdomen, or thigh as||
1192|031|H|directed by your doctor, usually once daily. Do not apply the gel||
1192|032|H|to open sores, areas with a rash, recently shaved, irritated, or||
1192|033|H|oily skin, or to where lotions or powders have been applied.||
1192|034|H|Gently rub into your skin until it dries. Do not continue rubbing||
1192|035|H|after the gel has dried. This medication may be used before or||
1192|036|H|after applying sunscreen.||
1192|037|H|   Oxybutynin gel is for use on the skin only. Avoid getting the||
1192|038|H|gel in the eyes, nose, or mouth. Wash your hands with soap and||
1192|039|H|water after applying this medication. If the gel gets in your||
1192|040|H|eyes, rinse your eyes right away with warm, clean water. Discard||
1192|041|H|the used packet safely away from children and pets.||
1192|042|H|   Apply the gel to a different area of skin with each dose. This||
1192|043|H|will decrease skin reactions.||
1192|044|H|   Allow this medication to dry completely on the skin before||
1192|045|H|getting dressed. Cover the area to prevent spreading the||
1192|046|H|medication through skin contact. If contact occurs, immediately||
1192|047|H|wash the area with soap and water. After applying the gel, wait 1||
1192|048|H|hour before exercising, bathing, showering, swimming, or getting||
1192|049|H|the application area wet to make sure all the drug is absorbed.||
1192|050|H|   This medication is flammable until dry. Avoid smoking or being||
1192|051|H|near open flames while using the medication and until the||
1192|052|H|medication has dried.||
1192|053|H|   Use this medication regularly in order to get the most benefit||
1192|054|H|from it. To help you remember, use it at the same time each day.||
1192|055|H|   Tell your doctor if your condition lasts or gets worse.||
1192|056|B|||
1192|057|S|SIDE EFFECTS:  Skin redness/itching/swelling at the application||
1192|058|S|site, dry mouth, constipation, dizziness, drowsiness, or blurred||
1192|059|S|vision may occur. If any of these effects last or get worse, tell||
1192|060|S|your doctor or pharmacist promptly.||
1192|061|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
1192|062|S|chips, chew (sugarless) gum, drink water or use a saliva||
1192|063|S|substitute.||
1192|064|S|   To prevent constipation, eat dietary fiber, drink enough||
1192|065|S|water, and exercise. You may also need to take a laxative. Ask||
1192|066|S|your pharmacist which type of laxative is right for you.||
1192|067|S|   Remember that this medication has been prescribed because your||
1192|068|S|doctor has judged that the benefit to you is greater than the||
1192|069|S|risk of side effects. Many people using this medication do not||
1192|070|S|have serious side effects.||
1192|071|S|   Tell your doctor right away if you have any serious side||
1192|072|S|effects, including: difficulty urinating, signs of kidney||
1192|073|S|infection (such as burning/painful/frequent urination, lower back||
1192|074|S|pain), mental/mood changes (such as confusion, hallucinations),||
1192|075|S|signs of stomach/intestinal blockage (such as nausea/vomiting||
1192|076|S|that doesn't stop, severe stomach pain, severe constipation).||
1192|077|S|   A very serious allergic reaction to this drug is rare.||
1192|078|S|However, get medical help right away if you notice any symptoms||
1192|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1192|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1192|081|S|breathing.||
1192|082|S|   This is not a complete list of possible side effects. If you||
1192|083|S|notice other effects not listed above, contact your doctor or||
1192|084|S|pharmacist.||
1192|085|S|   In the US -||
1192|086|S|   Call your doctor for medical advice about side effects. You||
1192|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1192|088|S|www.fda.gov/medwatch.||
1192|089|S|   In Canada - Call your doctor for medical advice about side||
1192|090|S|effects. You may report side effects to Health Canada at||
1192|091|S|1-866-234-2345.||
1192|092|B|||
1192|093|P|PRECAUTIONS:  Before using oxybutynin, tell your doctor or||
1192|094|P|pharmacist if you are allergic to it; or if you have any other||
1192|095|P|allergies. This product may contain inactive ingredients, which||
1192|096|P|can cause allergic reactions or other problems. Talk to your||
1192|097|P|pharmacist for more details.||
1192|098|P|   Before using this medication, tell your doctor or pharmacist||
1192|099|P|your medical history, especially of: blockage/slowed movement of||
1192|100|P|the stomach/intestines (such as severe constipation, gastric||
1192|101|P|retention, paralytic ileus), stomach/intestinal disease (such as||
1192|102|P|acid reflux, hiatal hernia, ulcerative colitis), problems||
1192|103|P|emptying your bladder (such as urinary retention, obstruction,||
1192|104|P|enlarged prostate), certain eye problem (glaucoma), liver||
1192|105|P|disease, kidney disease, certain muscle disease (myasthenia||
1192|106|P|gravis), Parkinson's disease, a certain nervous system disorder||
1192|107|P|(autonomic neuropathy).||
1192|108|P|   This drug may make you dizzy or drowsy or blur your vision.||
1192|109|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1192|110|P|drowsy. Do not drive, use machinery, or do anything that needs||
1192|111|P|alertness or clear vision until you can do it safely. Limit||
1192|112|P|alcoholic beverages. Talk to your doctor if you are using||
1192|113|P|marijuana (cannabis).||
1192|114|P|   Before having surgery, tell your doctor or dentist about all||
1192|115|P|the products you use (including prescription drugs,||
1192|116|P|nonprescription drugs, and herbal products).||
1192|117|P|   This medication may make you sweat less, making you more||
1192|118|P|likely to get heat stroke. Avoid doing things that may cause you||
1192|119|P|to overheat, such as hard work or exercise in hot weather, or||
1192|120|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1192|121|P|and dress lightly. If you overheat, quickly look for a place to||
1192|122|P|cool down and rest. Get medical help right away if you have a||
1192|123|P|fever that does not go away, mental/mood changes, headache, or||
1192|124|P|dizziness.||
1192|125|P|   Older adults may be more sensitive to the side effects of this||
1192|126|P|drug, especially drowsiness, confusion, constipation, trouble||
1192|127|P|urinating. Drowsiness and confusion can increase the risk of||
1192|128|P|falling.||
1192|129|P|   During pregnancy, this medication should be used only when||
1192|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
1192|131|P|   It is unknown if this drug passes into breast milk. Consult||
1192|132|P|your doctor before breastfeeding.||
1192|133|B|||
1192|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1192|135|I|medications work or increase your risk for serious side effects.||
1192|136|I|This document does not contain all possible drug interactions.||
1192|137|I|Keep a list of all the products you use (including||
1192|138|I|prescription/nonprescription drugs and herbal products) and share||
1192|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
1192|140|I|the dosage of any medicines without your doctor's approval.||
1192|141|I|   Some products that may interact with this drug include:||
1192|142|I|pramlintide, drugs that can irritate the esophagus/stomach (such||
1192|143|I|as potassium tablets/capsules, oral bisphosphonates including||
1192|144|I|alendronate).||
1192|145|I|   Tell your doctor or pharmacist if you are using other products||
1192|146|I|that cause drowsiness such as opioid pain or cough relievers||
1192|147|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
1192|148|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
1192|149|I|zolpidem), muscle relaxants (such as carisoprodol,||
1192|150|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1192|151|I|diphenhydramine).||
1192|152|I|   Check the labels on all your medicines (such as allergy or||
1192|153|I|cough-and-cold products) because they may contain ingredients||
1192|154|I|that can cause drowsiness, constipation or blurred vision. Ask||
1192|155|I|your pharmacist about using those products safely.||
1192|156|B|||
1192|157|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1192|158|O|has overdosed and has serious symptoms such as passing out or||
1192|159|O|trouble breathing, call 911. Otherwise, call a poison control||
1192|160|O|center right away. US residents can call 1-800-222-1222. Canada||
1192|161|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1192|162|O|include unusual excitement, agitation, fast/irregular heartbeat,||
1192|163|O|hot/flushed skin, fever.||
1192|164|B|||
1192|165|N|NOTES:  Do not share this medication with others.||
1192|166|B|||
1192|167|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1192|168|D|If it is near the time of the next dose, skip the missed dose.||
1192|169|D|Use your next dose at the regular time. Do not double the dose to||
1192|170|D|catch up.||
1192|171|B|||
1192|172|R|STORAGE:  Store at room temperature away from light and moisture.||
1192|173|R|Do not store in the bathroom. This medication is flammable. Keep||
1192|174|R|it away from heat and open flame. Throw out used gel packets in a||
1192|175|R|secure trash can. Do not save opened packets for later use. Keep||
1192|176|R|all medications away from children and pets.||
1192|177|R|   Do not flush medications down the toilet or pour them into a||
1192|178|R|drain unless instructed to do so. Properly discard this product||
1192|179|R|when it is expired or no longer needed. Consult your pharmacist||
1192|180|R|or local waste disposal company.||
1192|181|B|||
1192|182|A|Information last revised October 2025.||
1192|183|A|Copyright(c) 2025 First Databank, Inc.||
1192|184|B|||
1193|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1193|002|Z|does NOT have all possible information about this product. This||
1193|003|Z|information does not assure that this product is safe, effective,||
1193|004|Z|or appropriate for you. This information is not individual||
1193|005|Z|medical advice and does not substitute for the advice of your||
1193|006|Z|health care professional. Always ask your health care||
1193|007|Z|professional for complete information about this product and your||
1193|008|Z|specific health needs.||
1193|009|B|||
1193|010|T|MILNACIPRAN - ORAL||
1193|011|F|(mil-NA-si-pran)||
1193|012|B|||
1193|013|C|COMMON BRAND NAME(S): Savella||
1193|014|B|||
1193|015|W|WARNING:  Although not used for depression, this medication is in||
1193|016|W|the same class as antidepressant medications. Antidepressant||
1193|017|W|medications are used to treat a variety of conditions, including||
1193|018|W|depression and other mental/mood disorders. These medications can||
1193|019|W|help prevent suicidal thoughts/attempts and provide other||
1193|020|W|important benefits. However, studies have shown that a small||
1193|021|W|number of people (especially people younger than 25) who take||
1193|022|W|antidepressants for any condition may experience worsening||
1193|023|W|depression, other mental/mood symptoms, or suicidal||
1193|024|W|thoughts/attempts. It is very important to talk with the doctor||
1193|025|W|about the risks and benefits of antidepressant medication||
1193|026|W|(especially for people younger than 25), even if treatment is not||
1193|027|W|for a mental/mood condition.||
1193|028|W|   Tell the doctor right away if you notice worsening||
1193|029|W|depression/other psychiatric conditions, unusual behavior changes||
1193|030|W|(including possible suicidal thoughts/attempts), or other||
1193|031|W|mental/mood changes (including new/worsening anxiety, panic||
1193|032|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1193|033|W|impulsive actions, severe restlessness, very rapid speech). Be||
1193|034|W|especially watchful for these symptoms when a new antidepressant||
1193|035|W|is started or when the dose is changed.||
1193|036|B|||
1193|037|U|USES:  This medication is used to treat pain caused by a||
1193|038|U|condition called fibromyalgia that affects the muscles, tendons,||
1193|039|U|ligaments, and supporting tissues. Milnacipran belongs to a class||
1193|040|U|of drugs known as serotonin-norepinephrine reuptake inhibitors||
1193|041|U|(SNRIs). It works by helping to restore the balance of certain||
1193|042|U|natural substances (serotonin and norepinephrine) in the brain.||
1193|043|B|||
1193|044|H|HOW TO USE:  Read the Medication Guide provided by your||
1193|045|H|pharmacist before you start using milnacipran and each time you||
1193|046|H|get a refill. If you have any questions, consult your doctor or||
1193|047|H|pharmacist.||
1193|048|H|   Take this medication by mouth with or without food as directed||
1193|049|H|by your doctor, usually 2 times a day. If you have nausea, it may||
1193|050|H|help to take this medication with food.||
1193|051|H|   Dosage is based on your medical condition and response to||
1193|052|H|treatment.||
1193|053|H|   To reduce your risk of side effects, your doctor may start you||
1193|054|H|at a low dose and gradually increase your dose. Follow your||
1193|055|H|doctor's instructions carefully. Do not increase your dose or||
1193|056|H|take this medication more often than prescribed. Your condition||
1193|057|H|will not improve any faster, and the risk of serious side effects||
1193|058|H|may be increased.||
1193|059|H|   If you suddenly stop using this medication, you may have||
1193|060|H|withdrawal symptoms (such as mood swings, headache, tiredness,||
1193|061|H|sleep changes, brief feelings similar to electric shock). To help||
1193|062|H|prevent withdrawal, your doctor may lower your dose slowly.||
1193|063|H|Withdrawal is more likely if you have used milnacipran for a long||
1193|064|H|time or in high doses. Tell your doctor or pharmacist right away||
1193|065|H|if you have withdrawal.||
1193|066|H|   Tell your doctor if your condition does not get better or if||
1193|067|H|it gets worse.||
1193|068|B|||
1193|069|S|SIDE EFFECTS:  See also Warning section.||
1193|070|S|   Nausea, vomiting, dry mouth, constipation, loss of appetite,||
1193|071|S|dizziness, increased sweating, headache, or hot flashes||
1193|072|S|(flushing) may occur. If any of these effects last or get worse,||
1193|073|S|tell your doctor promptly.||
1193|074|S|   Remember that this medication has been prescribed because your||
1193|075|S|doctor has judged that the benefit to you is greater than the||
1193|076|S|risk of side effects. Many people using this medication do not||
1193|077|S|have serious side effects.||
1193|078|S|   This medication may raise your blood pressure. Check your||
1193|079|S|blood pressure regularly and tell your doctor if the results are||
1193|080|S|high.||
1193|081|S|   Tell your doctor right away if you have any serious side||
1193|082|S|effects, including: fast/pounding heartbeat, changes in sexual||
1193|083|S|ability, decreased interest in sex, painful/difficult urination,||
1193|084|S|seizures, yellowing eyes/skin, dark urine, severe||
1193|085|S|stomach/abdominal pain, easy bleeding/bruising.||
1193|086|S|   Get medical help right away if you have any very serious side||
1193|087|S|effects, including: black stools, vomit that looks like coffee||
1193|088|S|grounds, eye pain/swelling/redness, widened pupils, vision||
1193|089|S|changes (such as seeing rainbows around lights at night, blurred||
1193|090|S|vision).||
1193|091|S|   This medication may increase serotonin and rarely cause a very||
1193|092|S|serious condition called serotonin syndrome/toxicity. The risk||
1193|093|S|increases if you are also taking other drugs that increase||
1193|094|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1193|095|S|take (see Drug Interactions section). Get medical help right away||
1193|096|S|if you develop some of the following symptoms: fast heartbeat,||
1193|097|S|hallucinations, loss of coordination, severe dizziness, severe||
1193|098|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1193|099|S|unusual agitation/restlessness.||
1193|100|S|   A very serious allergic reaction to this drug is rare.||
1193|101|S|However, get medical help right away if you notice any symptoms||
1193|102|S|of a serious allergic reaction, including: rash, itching/swelling||
1193|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1193|104|S|breathing.||
1193|105|S|   This is not a complete list of possible side effects. If you||
1193|106|S|notice other effects not listed above, contact your doctor or||
1193|107|S|pharmacist.||
1193|108|S|   In the US -||
1193|109|S|   Call your doctor for medical advice about side effects. You||
1193|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1193|111|S|www.fda.gov/medwatch.||
1193|112|S|   In Canada - Call your doctor for medical advice about side||
1193|113|S|effects. You may report side effects to Health Canada at||
1193|114|S|1-866-234-2345.||
1193|115|B|||
1193|116|P|PRECAUTIONS:  Before taking milnacipran, tell your doctor or||
1193|117|P|pharmacist if you are allergic to it; or to levomilnacipran; or||
1193|118|P|if you have any other allergies. This product may contain||
1193|119|P|inactive ingredients, which can cause allergic reactions or other||
1193|120|P|problems. Talk to your pharmacist for more details.||
1193|121|P|   Before using this medication, tell your doctor or pharmacist||
1193|122|P|your medical history, especially of: kidney disease, liver||
1193|123|P|disease, alcohol use, personal or family history of glaucoma||
1193|124|P|(angle-closure type), personal or family history of psychiatric||
1193|125|P|disorders (such as bipolar/manic-depressive disorder), personal||
1193|126|P|or family history of suicide attempts, high blood pressure, heart||
1193|127|P|problems (such as chest pain, heart attack, fast/irregular||
1193|128|P|heartbeat), seizure disorder, dehydration, intestinal||
1193|129|P|ulcers/bleeding (peptic ulcer disease), mineral imbalance (low||
1193|130|P|level of sodium in the blood), painful/difficult urination (for||
1193|131|P|example, due to enlarged prostate).||
1193|132|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1193|133|P|can make you more dizzy. Do not drive, use machinery, or do||
1193|134|P|anything that needs alertness until you can do it safely. Avoid||
1193|135|P|alcoholic beverages. Talk to your doctor if you are using||
1193|136|P|marijuana (cannabis). Drinking alcohol can also increase your||
1193|137|P|risk of liver problems.||
1193|138|P|   Before having surgery, tell your doctor or dentist about all||
1193|139|P|the products you use (including prescription drugs,||
1193|140|P|nonprescription drugs, and herbal products).||
1193|141|P|   Older adults may be more sensitive to the side effects of this||
1193|142|P|drug, especially bleeding. Older adults may also be at greater||
1193|143|P|risk for mineral imbalance (low level of sodium in the blood)||
1193|144|P|while using this drug, especially if they are also taking "water||
1193|145|P|pills" (diuretics) with this medication.||
1193|146|P|   During pregnancy, this medication should be used only when||
1193|147|P|clearly needed. Discuss the risks and benefits with your doctor.||
1193|148|P|Babies born to mothers who have used this drug during the last 3||
1193|149|P|months of pregnancy may rarely develop withdrawal symptoms such||
1193|150|P|as feeding/breathing difficulties, seizures, muscle stiffness, or||
1193|151|P|constant crying. If you notice any of these symptoms in your||
1193|152|P|newborn, tell the doctor promptly.||
1193|153|P|   This medication passes into breast milk. Consult your doctor||
1193|154|P|before breastfeeding.||
1193|155|B|||
1193|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1193|157|I|medications work or increase your risk for serious side effects.||
1193|158|I|This document does not contain all possible drug interactions.||
1193|159|I|Keep a list of all the products you use (including||
1193|160|I|prescription/nonprescription drugs and herbal products) and share||
1193|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
1193|162|I|the dosage of any medicines without your doctor's approval.||
1193|163|I|   Some products that may interact with this drug are: "water||
1193|164|I|pills" (diuretics such as furosemide), other drugs that can cause||
1193|165|I|bleeding/bruising (including antiplatelet drugs such as||
1193|166|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
1193|167|I|such as dabigatran/warfarin).||
1193|168|I|   Taking MAO inhibitors with this medication may cause a serious||
1193|169|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1193|170|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1193|171|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1193|172|I|selegiline, tranylcypromine) during treatment with this||
1193|173|I|medication. Most MAO inhibitors should also not be taken for two||
1193|174|I|weeks before and at least 5 days after treatment with this||
1193|175|I|medication. Ask your doctor when to start or stop taking this||
1193|176|I|medication.||
1193|177|I|   Aspirin can increase the risk of bleeding when used with this||
1193|178|I|medication. However, if your doctor has told you to take low-dose||
1193|179|I|aspirin to prevent heart attack or stroke (usually 81-162||
1193|180|I|milligrams a day), you should keep taking the aspirin unless your||
1193|181|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1193|182|I|details.||
1193|183|I|   The risk of serotonin syndrome/toxicity increases if you are||
1193|184|I|also taking other drugs that increase serotonin. Examples include||
1193|185|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1193|186|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1193|187|I|other SNRIs such as duloxetine/venlafaxine), tryptophan, among||
1193|188|I|others. The risk of serotonin syndrome/toxicity may be more||
1193|189|I|likely when you start or increase the dose of these drugs.||
1193|190|I|   Milnacipran is very similar to levomilnacipran. Do not use||
1193|191|I|medications containing levomilnacipran while using milnacipran.||
1193|192|B|||
1193|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1193|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1193|195|O|poison control center right away. US residents can call||
1193|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1193|197|O|Symptoms of overdose may include: confusion, severe||
1193|198|O|drowsiness/dizziness.||
1193|199|B|||
1193|200|N|NOTES:  Do not share this medication with others.||
1193|201|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
1193|202|N|liver function) should be done while you are taking this||
1193|203|N|medication. Keep all medical and lab appointments. Consult your||
1193|204|N|doctor for more details.||
1193|205|B|||
1193|206|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1193|207|D|remember. If it is near the time of the next dose, skip the||
1193|208|D|missed dose. Take your next dose at the regular time. Do not||
1193|209|D|double the dose to catch up.||
1193|210|B|||
1193|211|R|STORAGE:  Store at room temperature away from light and moisture.||
1193|212|R|Do not store in the bathroom. Keep all medications away from||
1193|213|R|children and pets.||
1193|214|R|   Do not flush medications down the toilet or pour them into a||
1193|215|R|drain unless instructed to do so. Properly discard this product||
1193|216|R|when it is expired or no longer needed. Consult your pharmacist||
1193|217|R|or local waste disposal company.||
1193|218|B|||
1193|219|A|Information last revised October 2024.||
1193|220|A|Copyright(c) 2025 First Databank, Inc.||
1193|221|B|||
1194|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1194|002|Z|does NOT have all possible information about this product. This||
1194|003|Z|information does not assure that this product is safe, effective,||
1194|004|Z|or appropriate for you. This information is not individual||
1194|005|Z|medical advice and does not substitute for the advice of your||
1194|006|Z|health care professional. Always ask your health care||
1194|007|Z|professional for complete information about this product and your||
1194|008|Z|specific health needs.||
1194|009|B|||
1194|010|T|METHADONE DISPERSIBLE TABLET - ORAL||
1194|011|F|(METH-uh-doan)||
1194|012|B|||
1194|013|C|COMMON BRAND NAME(S): Methadose||
1194|014|B|||
1194|015|W|WARNING:  Methadone has a high risk for abuse. It can also cause||
1194|016|W|severe, possibly fatal, breathing problems and heartbeat||
1194|017|W|problems. These problems are more likely to happen when this||
1194|018|W|medication is first started, or when you are switching from||
1194|019|W|another opioid to methadone, or when the dose is increased.||
1194|020|W|Breathing problems from methadone may not happen right away after||
1194|021|W|taking a dose. Most heartbeat problems have happened in people||
1194|022|W|using large doses of methadone for pain relief, but this problem||
1194|023|W|can also occur in people taking smaller doses to treat opioid||
1194|024|W|addiction. Do not increase your dose or take this medication more||
1194|025|W|often than directed. Get medical help right away if you notice||
1194|026|W|unusual slow/shallow breathing, fast/irregular heartbeat, severe||
1194|027|W|dizziness, or fainting.||
1194|028|W|   Ask your doctor or pharmacist if you should have medication||
1194|029|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1194|030|W|Teach your family or household members about the signs of an||
1194|031|W|opioid overdose and how to treat it.||
1194|032|W|   Before using this medication, women of childbearing age should||
1194|033|W|talk with their doctor(s) about the risks and benefits. Pregnancy||
1194|034|W|may affect the amount of this drug in your body, so tell your||
1194|035|W|doctor if you are pregnant or if you plan to become pregnant.||
1194|036|W|During pregnancy, this medication should be used only when||
1194|037|W|clearly needed. It may slightly increase the risk of birth||
1194|038|W|defects if used during the first two months of pregnancy. Also,||
1194|039|W|using it for a long time or in high doses near the expected||
1194|040|W|delivery date may harm the unborn baby. To lessen the risk, take||
1194|041|W|the smallest effective dose for the shortest possible time.||
1194|042|W|Babies born to mothers who use this drug for a long time may||
1194|043|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1194|044|W|doctor right away if you notice any symptoms in your newborn baby||
1194|045|W|such as nonstop crying, slow/shallow breathing, irritability,||
1194|046|W|shaking, vomiting, diarrhea, poor feeding, or difficulty gaining||
1194|047|W|weight.||
1194|048|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1194|049|W|or abuse. If a child accidentally swallows this drug, get medical||
1194|050|W|help right away.||
1194|051|B|||
1194|052|U|USES:  This medication is used to treat opioid use disorder as||
1194|053|U|part of an approved treatment program. Methadone belongs to a||
1194|054|U|class of drugs known as opioid analgesics. It helps prevent||
1194|055|U|withdrawal symptoms caused by stopping other opioids.||
1194|056|B|||
1194|057|V|OTHER USES:  This section contains uses of this drug that are not||
1194|058|V|listed in the approved professional labeling for the drug but||
1194|059|V|that may be prescribed by your health care professional. Use this||
1194|060|V|drug for a condition that is listed in this section only if it||
1194|061|V|has been so prescribed by your health care professional.||
1194|062|V|   This drug may also be used for severe pain. Do not use||
1194|063|V|methadone to relieve pain that is mild or that will go away in a||
1194|064|V|few days. This medication is not for occasional ("as needed")||
1194|065|V|use.||
1194|066|B|||
1194|067|H|HOW TO USE:  See also Warning section.||
1194|068|H|   Read the Patient Information Leaflet if available from your||
1194|069|H|pharmacist before you start using methadone and each time you get||
1194|070|H|a refill. If you have any questions, ask your doctor or||
1194|071|H|pharmacist.||
1194|072|H|   Take this medication by mouth as directed by your doctor. You||
1194|073|H|may take this drug with or without food. If you have nausea, it||
1194|074|H|may help to take this drug with food. Ask your doctor or||
1194|075|H|pharmacist about other ways to decrease nausea (such as lying||
1194|076|H|down for 1 to 2 hours with as little head movement as possible).||
1194|077|H|   Do not chew or swallow the tablets. Before taking, dissolve||
1194|078|H|the dose in 4 ounces (120 milliliters) of water or an acidic||
1194|079|H|fruit drink (such as orange juice). Drink all of the mixture||
1194|080|H|immediately. If there is any medication left in the cup, add a||
1194|081|H|small amount of liquid and drink all of the mixture. Do not||
1194|082|H|prepare a supply in advance. Do not inject this medication.||
1194|083|H|   If you are taking this medication to treat moderate to severe||
1194|084|H|pain, take it on a regular schedule as directed by your doctor,||
1194|085|H|not as needed for sudden (breakthrough) pain.||
1194|086|H|   The dosage is based on your medical condition and response to||
1194|087|H|treatment.||
1194|088|H|   Suddenly stopping this medication may cause withdrawal,||
1194|089|H|especially if you have used it for a long time or in high doses.||
1194|090|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1194|091|H|Tell your doctor or pharmacist right away if you have any||
1194|092|H|withdrawal symptoms such as restlessness, mental/mood changes||
1194|093|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1194|094|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1194|095|H|aches, or sudden changes in behavior.||
1194|096|H|   When this medication is used for a long time, it may not work||
1194|097|H|as well. Talk with your doctor if this medication stops working||
1194|098|H|well.||
1194|099|H|   Though it helps many people, this medication may sometimes||
1194|100|H|cause addiction. This risk may be higher if you have a||
1194|101|H|mental/mood disorder or a substance use disorder (such as overuse||
1194|102|H|of or addiction to drugs/alcohol). Take this medication exactly||
1194|103|H|as prescribed to lower the risk of addiction. Stopping methadone||
1194|104|H|maintenance treatment has a high risk of return to opioid abuse.||
1194|105|H|Ask your doctor or pharmacist for more details.||
1194|106|H|   Tell your doctor if your condition does not get better or if||
1194|107|H|it gets worse.||
1194|108|B|||
1194|109|S|SIDE EFFECTS:  See also Warning section.||
1194|110|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
1194|111|S|dry mouth, drowsiness, or sweating may occur. Some of these side||
1194|112|S|effects may decrease after you have been using this medication||
1194|113|S|for a while. If any of these effects last or get worse, tell your||
1194|114|S|doctor or pharmacist promptly.||
1194|115|S|   To prevent constipation, eat dietary fiber, drink enough||
1194|116|S|water, and exercise. You may also need to take a laxative. Ask||
1194|117|S|your pharmacist which type of laxative is right for you.||
1194|118|S|   To reduce the risk of dizziness and lightheadedness, get up||
1194|119|S|slowly when rising from a sitting or lying position.||
1194|120|S|   Remember that this medication has been prescribed because your||
1194|121|S|doctor has judged that the benefit to you is greater than the||
1194|122|S|risk of side effects. Many people using this medication do not||
1194|123|S|have serious side effects.||
1194|124|S|   Tell your doctor right away if you have any serious side||
1194|125|S|effects, including: interrupted breathing during sleep (sleep||
1194|126|S|apnea), mental/mood changes (such as agitation, confusion,||
1194|127|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
1194|128|S|signs of your adrenal glands not working well (such as loss of||
1194|129|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
1194|130|S|   Get medical help right away if you have any very serious side||
1194|131|S|effects, including: seizure, unusual drowsiness/difficulty waking||
1194|132|S|up.||
1194|133|S|   A very serious allergic reaction to this drug is rare.||
1194|134|S|However, get medical help right away if you notice any symptoms||
1194|135|S|of a serious allergic reaction, including: rash, itching/swelling||
1194|136|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1194|137|S|breathing.||
1194|138|S|   This is not a complete list of possible side effects. If you||
1194|139|S|notice other effects not listed above, contact your doctor or||
1194|140|S|pharmacist.||
1194|141|S|   In the US -||
1194|142|S|   Call your doctor for medical advice about side effects. You||
1194|143|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1194|144|S|www.fda.gov/medwatch.||
1194|145|S|   In Canada - Call your doctor for medical advice about side||
1194|146|S|effects. You may report side effects to Health Canada at||
1194|147|S|1-866-234-2345.||
1194|148|B|||
1194|149|P|PRECAUTIONS:  Before taking methadone, tell your doctor or||
1194|150|P|pharmacist if you are allergic to it; or if you have any other||
1194|151|P|allergies. This product may contain inactive ingredients, which||
1194|152|P|can cause allergic reactions or other problems. Talk to your||
1194|153|P|pharmacist for more details.||
1194|154|P|   Before using this medication, tell your doctor or pharmacist||
1194|155|P|your medical history, especially of: brain disorders (such as||
1194|156|P|head injury, tumor, seizures), breathing problems (such as||
1194|157|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1194|158|P|kidney disease, liver disease, mental/mood disorders (such as||
1194|159|P|confusion, depression, thoughts of suicide), personal or family||
1194|160|P|history of a substance use disorder (such as overuse of or||
1194|161|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
1194|162|P|blockage, constipation, diarrhea due to infection, paralytic||
1194|163|P|ileus), difficulty urinating (such as due to enlarged prostate),||
1194|164|P|disease of the pancreas (pancreatitis), gallbladder disease.||
1194|165|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1194|166|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1194|167|P|machinery, or do anything that needs alertness until you can do||
1194|168|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1194|169|P|are using marijuana (cannabis).||
1194|170|P|   Methadone may cause a condition that affects the heart rhythm||
1194|171|P|(QT prolongation). QT prolongation can rarely result in serious||
1194|172|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1194|173|P|as severe dizziness, fainting) that need medical attention right||
1194|174|P|away.||
1194|175|P|   The risk of QT prolongation may be increased if you have||
1194|176|P|certain medical conditions or are taking other drugs that may||
1194|177|P|cause QT prolongation. Before using methadone, tell your doctor||
1194|178|P|or pharmacist of all the drugs you take and if you have any of||
1194|179|P|the following conditions: certain heart problems (heart failure,||
1194|180|P|slow heartbeat, QT prolongation in the EKG), family history of||
1194|181|P|certain heart problems (QT prolongation in the EKG, sudden||
1194|182|P|cardiac death).||
1194|183|P|   Low levels of potassium or magnesium in the blood may also||
1194|184|P|increase your risk of QT prolongation. This risk may increase if||
1194|185|P|you use certain drugs (such as diuretics/"water pills") or if you||
1194|186|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1194|187|P|Talk to your doctor about using methadone safely.||
1194|188|P|   Before having surgery, tell your doctor or dentist about all||
1194|189|P|the products you use (including prescription drugs,||
1194|190|P|nonprescription drugs, and herbal products).||
1194|191|P|   Older adults may be more sensitive to the effects of this||
1194|192|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
1194|193|P|breathing, and QT prolongation (see above).||
1194|194|P|   During pregnancy, this medication should be used only when||
1194|195|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1194|196|P|benefits with your doctor. (See also Warning section.)||
1194|197|P|   This drug passes into breast milk and may have undesirable||
1194|198|P|effects on a nursing infant. Tell the doctor immediately if your||
1194|199|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1194|200|P|breathing. Consult your doctor before breastfeeding or if you||
1194|201|P|plan to stop breastfeeding.||
1194|202|B|||
1194|203|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1194|204|I|medications work or increase your risk for serious side effects.||
1194|205|I|This document does not contain all possible drug interactions.||
1194|206|I|Keep a list of all the products you use (including||
1194|207|I|prescription/nonprescription drugs and herbal products) and share||
1194|208|I|it with your doctor and pharmacist. Do not start, stop, or change||
1194|209|I|the dosage of any medicines without your doctor's approval.||
1194|210|I|   Some products that may interact with this drug include:||
1194|211|I|certain pain medications (mixed opioid agonist-antagonists such||
1194|212|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1194|213|I|samidorphan.||
1194|214|I|   Taking MAO inhibitors with this medication may cause a serious||
1194|215|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
1194|216|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1194|217|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1194|218|I|selegiline, tranylcypromine) during treatment with this||
1194|219|I|medication. Most MAO inhibitors should also not be taken for two||
1194|220|I|weeks before and after treatment with this medication. Ask your||
1194|221|I|doctor when to start or stop taking this medication.||
1194|222|I|   Other medications can affect the removal of methadone from||
1194|223|I|your body, which may affect how methadone works. Examples include||
1194|224|I|St. John's wort, azole antifungals (such as itraconazole),||
1194|225|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
1194|226|I|rifampin), drugs used to treat seizures (such as carbamazepine),||
1194|227|I|among others.||
1194|228|I|   The risk of serious side effects (such as slow/shallow||
1194|229|I|breathing, severe drowsiness/dizziness) may be increased if this||
1194|230|I|medication is taken with other products that may also affect||
1194|231|I|breathing or cause drowsiness. Tell your doctor or pharmacist if||
1194|232|I|you are taking other products such as alcohol, marijuana||
1194|233|I|(cannabis), allergy or cough-and-cold products, medicine for||
1194|234|I|sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle||
1194|235|I|relaxants, and psychiatric medicines (such as risperidone,||
1194|236|I|amitriptyline, trazodone). Your medications or doses of your||
1194|237|I|medications may need to be changed.||
1194|238|I|   This medication may interfere with certain lab tests (such as||
1194|239|I|amylase/lipase levels), possibly causing false test results. Make||
1194|240|I|sure lab personnel and all your doctors know you use this drug.||
1194|241|B|||
1194|242|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1194|243|O|as passing out or trouble breathing, give them naloxone or||
1194|244|O|nalmefene if available, then call 911. If the person is awake and||
1194|245|O|has no symptoms, call a poison control center right away. US||
1194|246|O|residents can call 1-800-222-1222. Canada residents can call||
1194|247|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1194|248|O|breathing, slow heartbeat, coma.||
1194|249|B|||
1194|250|N|NOTES:  Do not share this medication with others. Sharing it is||
1194|251|N|against the law.||
1194|252|N|   This medication has been prescribed for your current condition||
1194|253|N|only. Do not use it later for another condition unless told to do||
1194|254|N|so by your doctor. A different medication may be necessary in||
1194|255|N|those cases.||
1194|256|B|||
1194|257|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1194|258|D|remember. If it is near the time of the next dose, skip the||
1194|259|D|missed dose. Take your next dose at the regular time. Do not||
1194|260|D|double the dose to catch up.||
1194|261|B|||
1194|262|R|STORAGE:  Store at room temperature away from light and moisture.||
1194|263|R|Do not store in the bathroom. Keep all medications away from||
1194|264|R|children and pets. See also Warning section.||
1194|265|R|   Do not flush medications down the toilet or pour them into a||
1194|266|R|drain unless instructed to do so. Properly discard this product||
1194|267|R|when it is expired or no longer needed. Consult your pharmacist||
1194|268|R|or local waste disposal company.||
1194|269|B|||
1194|270|A|Information last revised August 2025.||
1194|271|A|Copyright(c) 2025 First Databank, Inc.||
1194|272|B|||
1196|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1196|002|Z|does NOT have all possible information about this product. This||
1196|003|Z|information does not assure that this product is safe, effective,||
1196|004|Z|or appropriate for you. This information is not individual||
1196|005|Z|medical advice and does not substitute for the advice of your||
1196|006|Z|health care professional. Always ask your health care||
1196|007|Z|professional for complete information about this product and your||
1196|008|Z|specific health needs.||
1196|009|B|||
1196|010|T|AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE - ORAL||
1196|011|F|(am-LOE-di-peen/val-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)||
1196|012|B|||
1196|013|C|COMMON BRAND NAME(S): Exforge HCT||
1196|014|B|||
1196|015|W|WARNING:  Valsartan can cause serious (possibly fatal) harm to an||
1196|016|W|unborn baby if used during pregnancy. It is important to prevent||
1196|017|W|pregnancy while taking this medication. Consult your doctor for||
1196|018|W|more details and to discuss the use of reliable forms of birth||
1196|019|W|control while taking this medication. If you are planning||
1196|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
1196|021|W|your doctor right away.||
1196|022|B|||
1196|023|U|USES:  This product is used to treat high blood pressure.||
1196|024|U|Lowering high blood pressure helps prevent strokes, heart||
1196|025|U|attacks, and kidney problems.||
1196|026|U|   This product contains 3 medications: amlodipine, valsartan,||
1196|027|U|and hydrochlorothiazide. Amlodipine is a calcium channel blocker,||
1196|028|U|and valsartan is an angiotensin receptor blocker (ARB). They both||
1196|029|U|work by relaxing blood vessels so blood can flow more easily.||
1196|030|U|Hydrochlorothiazide is called a "water pill" (diuretic) and||
1196|031|U|causes your body to get rid of extra salt and water by making||
1196|032|U|more urine.||
1196|033|B|||
1196|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1196|035|H|from your pharmacist before you start taking this product and||
1196|036|H|each time you get a refill. If you have any questions, ask your||
1196|037|H|doctor or pharmacist.||
1196|038|H|   Take this medication by mouth with or without food as directed||
1196|039|H|by your doctor, usually once daily. If you take this drug too||
1196|040|H|close to bedtime, you may need to wake up to urinate. It is best||
1196|041|H|to take this medication at least 4 hours before your bedtime.||
1196|042|H|   The dosage is based on your medical condition and response to||
1196|043|H|treatment.||
1196|044|H|   Take this medication regularly to get the most benefit from||
1196|045|H|it. To help you remember, take it at the same time each day. It||
1196|046|H|may take up to 2 weeks before you get the full benefit of this||
1196|047|H|product. Keep taking this product even if you feel well. Most||
1196|048|H|people with high blood pressure do not feel sick.||
1196|049|H|   If you also take certain drugs to lower your cholesterol (bile||
1196|050|H|acid-binding resins such as cholestyramine, colestipol), take||
1196|051|H|amlodipine/valsartan/hydrochlorothiazide at least 4 hours before||
1196|052|H|or at least 4 to 6 hours after these medications.||
1196|053|H|   Tell your doctor if your condition does not get better or if||
1196|054|H|it gets worse (your blood pressure readings remain high or||
1196|055|H|increase).||
1196|056|B|||
1196|057|S|SIDE EFFECTS:  Dizziness, lightheadedness, or headache may occur||
1196|058|S|as your body adjusts to the medication. If any of these effects||
1196|059|S|last or get worse, tell your doctor or pharmacist promptly.||
1196|060|S|   To reduce the risk of dizziness and lightheadedness, get up||
1196|061|S|slowly when rising from a sitting or lying position.||
1196|062|S|   Remember that this medication has been prescribed because your||
1196|063|S|doctor has judged that the benefit to you is greater than the||
1196|064|S|risk of side effects. Many people using this medication do not||
1196|065|S|have serious side effects.||
1196|066|S|   This product may cause dehydration and electrolyte imbalance.||
1196|067|S|Tell your doctor right away if you have any symptoms of||
1196|068|S|dehydration or electrolyte imbalance, including: unusual dry||
1196|069|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
1196|070|S|heartbeat, or confusion.||
1196|071|S|   Tell your doctor right away if you have any serious side||
1196|072|S|effects, including: fainting, severe tiredness, big toe/joint||
1196|073|S|pain, swelling hands/ankles/feet, signs of infection (such as||
1196|074|S|sore throat that doesn't go away, fever, chills), signs of kidney||
1196|075|S|problems (such as change in the amount of urine).||
1196|076|S|   Get medical help right away if you have any very serious side||
1196|077|S|effects, including: decrease in vision, eye pain.||
1196|078|S|   Some people who already have severe heart disease may rarely||
1196|079|S|develop worsening chest pain or a heart attack after starting||
1196|080|S|this medication or increasing the dose. Get medical help right||
1196|081|S|away if you experience: worsening chest pain, symptoms of a heart||
1196|082|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
1196|083|S|unusual sweating).||
1196|084|S|   A very serious allergic reaction to this drug is rare.||
1196|085|S|However, get medical help right away if you notice any symptoms||
1196|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1196|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1196|088|S|breathing.||
1196|089|S|   This is not a complete list of possible side effects. If you||
1196|090|S|notice other effects not listed above, contact your doctor or||
1196|091|S|pharmacist.||
1196|092|S|   In the US -||
1196|093|S|   Call your doctor for medical advice about side effects. You||
1196|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1196|095|S|www.fda.gov/medwatch.||
1196|096|S|   In Canada - Call your doctor for medical advice about side||
1196|097|S|effects. You may report side effects to Health Canada at||
1196|098|S|1-866-234-2345.||
1196|099|B|||
1196|100|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1196|101|P|pharmacist if you are allergic to amlodipine, valsartan, or||
1196|102|P|hydrochlorothiazide; or if you have any other allergies. This||
1196|103|P|product may contain inactive ingredients, which can cause||
1196|104|P|allergic reactions or other problems. Talk to your pharmacist for||
1196|105|P|more details.||
1196|106|P|   Before using this medication, tell your doctor or pharmacist||
1196|107|P|your medical history, especially of: kidney disease, liver||
1196|108|P|disease, dehydration, untreated electrolytes imbalance (such as||
1196|109|P|high/low potassium, low magnesium, high calcium), gout, lupus,||
1196|110|P|certain heart valve conditions (aortic or mitral stenosis), skin||
1196|111|P|cancer.||
1196|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1196|113|P|can make you more dizzy. Do not drive, use machinery, or do||
1196|114|P|anything that needs alertness until you can do it safely. Limit||
1196|115|P|alcoholic beverages. Talk to your doctor if you are using||
1196|116|P|marijuana (cannabis).||
1196|117|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1196|118|P|and cause you to feel lightheaded. Tell your doctor if you have||
1196|119|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1196|120|P|of fluids unless your doctor tells you not to.||
1196|121|P|   If you have diabetes, this product may affect your blood||
1196|122|P|sugar. Check your blood sugar regularly as directed and share the||
1196|123|P|results with your doctor. Your doctor may need to adjust your||
1196|124|P|diabetes medication, exercise program, or diet.||
1196|125|P|   This product may affect your potassium levels. Before using||
1196|126|P|potassium supplements or salt substitutes that contain potassium,||
1196|127|P|consult your doctor or pharmacist.||
1196|128|P|   This medication may make you more sensitive to the sun. It may||
1196|129|P|also increase your risk for skin cancer, especially if you take||
1196|130|P|it for a long time. Limit your time in the sun. Avoid tanning||
1196|131|P|booths and sunlamps. Use sunscreen and wear protective clothing||
1196|132|P|when outdoors. Tell your doctor right away if you get sunburned,||
1196|133|P|have skin blisters/redness, or notice new or changed moles/skin||
1196|134|P|lesions.||
1196|135|P|   Before having surgery, tell your doctor or dentist about all||
1196|136|P|the products you use (including prescription drugs,||
1196|137|P|nonprescription drugs, and herbal products).||
1196|138|P|   Older adults may be more sensitive to the side effects of this||
1196|139|P|drug, especially dizziness and change in the amount of urine||
1196|140|P|(kidney problems).||
1196|141|P|   Tell your doctor if you are pregnant or plan to become||
1196|142|P|pregnant. You should not become pregnant while using this||
1196|143|P|medication. Valsartan may harm an unborn baby. If you become||
1196|144|P|pregnant, talk to your doctor right away about the risks and||
1196|145|P|benefits of this medication. See also Warning section.||
1196|146|P|   It is unknown if valsartan passes into breast milk.||
1196|147|P|Hydrochlorothiazide and amlodipine pass into breast milk. Consult||
1196|148|P|your doctor before breastfeeding.||
1196|149|B|||
1196|150|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
1196|151|I|   Drug interactions may change how your medications work or||
1196|152|I|increase your risk for serious side effects. This document does||
1196|153|I|not contain all possible drug interactions. Keep a list of all||
1196|154|I|the products you use (including prescription/nonprescription||
1196|155|I|drugs and herbal products) and share it with your doctor and||
1196|156|I|pharmacist. Do not start, stop, or change the dosage of any||
1196|157|I|medicines without your doctor's approval.||
1196|158|I|   Some products that may interact with this drug include:||
1196|159|I|aliskiren, dofetilide, lithium, drugs that may increase the level||
1196|160|I|of potassium in the blood (such as sparsentan, ACE inhibitors||
1196|161|I|including benazepril/lisinopril, birth control pills containing||
1196|162|I|drospirenone).||
1196|163|I|   Some products have ingredients that could raise your blood||
1196|164|I|pressure. Tell your pharmacist what products you are using, and||
1196|165|I|ask how to use them safely (especially cough-and-cold products,||
1196|166|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1196|167|I|   This medication may interfere with certain lab tests, possibly||
1196|168|I|causing false test results. Make sure lab personnel and all your||
1196|169|I|doctors know you use this drug.||
1196|170|B|||
1196|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1196|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1196|173|O|poison control center right away. US residents can call||
1196|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1196|175|O|Symptoms of overdose may include: severe dizziness, fainting.||
1196|176|B|||
1196|177|N|NOTES:  Do not share this medication with others.||
1196|178|N|   Lifestyle changes that may help this medication work better||
1196|179|N|include exercising, stopping smoking, and eating a||
1196|180|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1196|181|N|details.||
1196|182|N|   Lab and/or medical tests (such as kidney function, potassium||
1196|183|N|levels, skin exams, cholesterol levels) should be done while you||
1196|184|N|are taking this product. Keep all medical and lab appointments.||
1196|185|N|   Have your blood pressure checked regularly while taking this||
1196|186|N|medication. Learn how to monitor your own blood pressure at home,||
1196|187|N|and share the results with your doctor.||
1196|188|B|||
1196|189|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1196|190|D|remember. If it is near the time of the next dose, skip the||
1196|191|D|missed dose. Take your next dose at the regular time. Do not||
1196|192|D|double the dose to catch up.||
1196|193|B|||
1196|194|R|STORAGE:  Store at room temperature away from light and moisture.||
1196|195|R|Do not store in the bathroom. Keep all medications away from||
1196|196|R|children and pets.||
1196|197|R|   Do not flush medications down the toilet or pour them into a||
1196|198|R|drain unless instructed to do so. Properly discard this product||
1196|199|R|when it is expired or no longer needed. Consult your pharmacist||
1196|200|R|or local waste disposal company.||
1196|201|B|||
1196|202|A|Information last revised March 2025.||
1196|203|A|Copyright(c) 2025 First Databank, Inc.||
1196|204|B|||
1197|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1197|002|Z|does NOT have all possible information about this product. This||
1197|003|Z|information does not assure that this product is safe, effective,||
1197|004|Z|or appropriate for you. This information is not individual||
1197|005|Z|medical advice and does not substitute for the advice of your||
1197|006|Z|health care professional. Always ask your health care||
1197|007|Z|professional for complete information about this product and your||
1197|008|Z|specific health needs.||
1197|009|B|||
1197|010|T|CONCENTRATED INSULIN REGULAR HUMAN - INJECTION||
1197|011|F|(IN-su-lin)||
1197|012|B|||
1197|013|C|COMMON BRAND NAME(S): Humulin R||
1197|014|B|||
1197|015|U|USES:  Concentrated insulin regular is used with a proper diet||
1197|016|U|and exercise program to control high blood sugar in people with||
1197|017|U|diabetes who require large doses of insulin (more than 200 units||
1197|018|U|per day). Controlling high blood sugar helps prevent kidney||
1197|019|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1197|020|U|function problems. Proper control of diabetes may also lessen||
1197|021|U|your risk of a heart attack or stroke.||
1197|022|U|   This man-made insulin product is the same as human insulin. It||
1197|023|U|replaces the insulin that your body would normally make. It works||
1197|024|U|right away like regular insulin but its effects last longer. It||
1197|025|U|works by helping blood sugar (glucose) get into cells so your||
1197|026|U|body can use it for energy. This medication may be used alone or||
1197|027|U|with other oral diabetes drugs (such as metformin).||
1197|028|B|||
1197|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1197|030|H|from your pharmacist before you start using this medication and||
1197|031|H|each time you get a refill. Ask your health care professional how||
1197|032|H|to prepare and use this medication. If you have any questions,||
1197|033|H|ask your doctor or pharmacist.||
1197|034|H|   This insulin product is a high-strength concentrated liquid.||
1197|035|H|If you are using the vial, use the proper syringe prescribed by||
1197|036|H|your doctor to make sure you are measuring the correct dose.||
1197|037|H|   Inject this medication under the skin as directed by your||
1197|038|H|doctor, usually 2 to 3 times daily before meals. Because this||
1197|039|H|insulin is fast-acting, do not use this insulin product if you||
1197|040|H|are unable to eat within 30 minutes after the injection or if you||
1197|041|H|have low blood sugar. Not eating right after a dose of this||
1197|042|H|insulin may lead to low blood sugar (hypoglycemia). This||
1197|043|H|injection is given in the stomach area, the thigh, the buttocks,||
1197|044|H|or the back of the upper arm. Do not inject into a vein or muscle||
1197|045|H|because very low blood sugar may occur.||
1197|046|H|   The dosage is based on your medical condition and response to||
1197|047|H|treatment. Measure each dose very carefully because even small||
1197|048|H|changes in the amount of insulin may have a large effect on your||
1197|049|H|blood sugar.||
1197|050|H|   Before using, check this product for particles or||
1197|051|H|discoloration. If either is present, do not use the insulin.||
1197|052|H|Before injecting each dose, clean the skin you are going to||
1197|053|H|inject into (the injection site) with rubbing alcohol. Change the||
1197|054|H|injection site each time to lessen injury under the skin (for||
1197|055|H|example, pits/lumps or thickened skin). Do not inject into skin||
1197|056|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
1197|057|H|not rub the injection site after a shot. Do not inject cold||
1197|058|H|insulin because this can be painful. The insulin container you||
1197|059|H|are currently using can be kept at room temperature. Learn how to||
1197|060|H|store and discard medical supplies safely.||
1197|061|H|   This product should not be mixed with any other insulins.||
1197|062|H|   Do not change brands or types of insulin without directions on||
1197|063|H|how to do so from your doctor.||
1197|064|H|   Do not share your pen device with another person, even if the||
1197|065|H|needle is changed. You may give other people a serious infection,||
1197|066|H|or get a serious infection from them.||
1197|067|H|   Use this medication regularly to get the most benefit from it.||
1197|068|H|To help you remember, use it at the same times each day.||
1197|069|H|   Tell your doctor if your condition does not get better or if||
1197|070|H|it gets worse (your blood sugar is too high or too low).||
1197|071|B|||
1197|072|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
1197|073|S|swelling, or itching) or weight gain may occur. If any of these||
1197|074|S|effects last or get worse, tell your doctor or pharmacist||
1197|075|S|promptly.||
1197|076|S|   Remember that this medication has been prescribed because your||
1197|077|S|doctor has judged that the benefit to you is greater than the||
1197|078|S|risk of side effects. Many people using this medication do not||
1197|079|S|have serious side effects.||
1197|080|S|   Tell your doctor right away if you have any serious side||
1197|081|S|effects, including: signs of low potassium level in the blood||
1197|082|S|(such as muscle cramps, weakness, irregular heartbeat).||
1197|083|S|   This medication can cause low blood sugar (hypoglycemia). This||
1197|084|S|may occur if you do not get enough calories from food or if you||
1197|085|S|do unusually heavy exercise. Symptoms of low blood sugar include||
1197|086|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
1197|087|S|dizziness, or tingling hands/feet. It is a good habit to carry||
1197|088|S|glucose tablets or gel to treat low blood sugar. If you don't||
1197|089|S|have these reliable forms of glucose, rapidly raise your blood||
1197|090|S|sugar by eating a quick source of sugar such as table sugar,||
1197|091|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
1197|092|S|doctor right away about the reaction and the use of this product.||
1197|093|S|To help prevent low blood sugar, eat meals on a regular schedule,||
1197|094|S|and do not skip meals. Check with your doctor or pharmacist to||
1197|095|S|find out what you should do if you miss a meal.||
1197|096|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1197|097|S|thirst/urination. If these symptoms occur, tell your doctor right||
1197|098|S|away. Your doctor may need to adjust your diabetes medication,||
1197|099|S|exercise program, or diet.||
1197|100|S|   A very serious allergic reaction to this drug is rare.||
1197|101|S|However, get medical help right away if you notice any symptoms||
1197|102|S|of a serious allergic reaction, including: rash, itching/swelling||
1197|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1197|104|S|breathing.||
1197|105|S|   This is not a complete list of possible side effects. If you||
1197|106|S|notice other effects not listed above, contact your doctor or||
1197|107|S|pharmacist.||
1197|108|S|   In the US -||
1197|109|S|   Call your doctor for medical advice about side effects. You||
1197|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1197|111|S|www.fda.gov/medwatch.||
1197|112|S|   In Canada - Call your doctor for medical advice about side||
1197|113|S|effects. You may report side effects to Health Canada at||
1197|114|S|1-866-234-2345.||
1197|115|B|||
1197|116|P|PRECAUTIONS:  Before using concentrated insulin regular, tell||
1197|117|P|your doctor or pharmacist if you are allergic to it; or to other||
1197|118|P|insulins; or if you have any other allergies. This product may||
1197|119|P|contain inactive ingredients, which can cause allergic reactions||
1197|120|P|or other problems. Talk to your pharmacist for more details.||
1197|121|P|   Do not use this medication when you have low blood sugar||
1197|122|P|(hypoglycemia).||
1197|123|P|   Before using this medication, tell your doctor or pharmacist||
1197|124|P|your medical history, especially of: kidney disease, liver||
1197|125|P|disease.||
1197|126|P|   You may experience blurred vision, dizziness, or drowsiness||
1197|127|P|due to extremely low or high blood sugar. Do not drive, use||
1197|128|P|machinery, or do anything that needs alertness or clear vision||
1197|129|P|until you can do it safely.||
1197|130|P|   Limit alcohol while using this medication because it can||
1197|131|P|increase the risk of developing low blood sugar.||
1197|132|P|   It may be harder to control your blood sugar when your body is||
1197|133|P|stressed (such as due to fever, infection, injury, or surgery).||
1197|134|P|Consult your doctor because this may require a change in your||
1197|135|P|treatment plan, medications, or blood sugar testing.||
1197|136|P|   Before having surgery, tell your doctor or dentist about all||
1197|137|P|the products you use (including prescription drugs,||
1197|138|P|nonprescription drugs, and herbal products).||
1197|139|P|   Check your blood sugar before and after exercise. You may need||
1197|140|P|a snack before exercising.||
1197|141|P|   If traveling across time zones, ask your doctor about how to||
1197|142|P|adjust your insulin schedule. Take extra insulin and supplies||
1197|143|P|with you.||
1197|144|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
1197|145|P|cause or worsen diabetes. Discuss a plan with your doctor for||
1197|146|P|managing your blood sugar while pregnant. Your doctor may change||
1197|147|P|your diabetes treatment during your pregnancy (such as diet and||
1197|148|P|medications including insulin).||
1197|149|P|   This medication passes into breast milk, but is unlikely to||
1197|150|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1197|151|P|Your insulin needs may change while breastfeeding.||
1197|152|B|||
1197|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1197|154|I|medications work or increase your risk for serious side effects.||
1197|155|I|This document does not contain all possible drug interactions.||
1197|156|I|Keep a list of all the products you use (including||
1197|157|I|prescription/nonprescription drugs and herbal products) and share||
1197|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
1197|159|I|the dosage of any medicines without your doctor's approval.||
1197|160|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1197|161|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1197|162|I|heartbeat you would usually feel when your blood sugar falls too||
1197|163|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1197|164|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1197|165|I|   Many drugs can affect your blood sugar, making it harder to||
1197|166|I|control. Before you start, stop, or change any medication, talk||
1197|167|I|with your doctor or pharmacist about how the medication may||
1197|168|I|affect your blood sugar. Check your blood sugar regularly as||
1197|169|I|directed and share the results with your doctor. Tell your doctor||
1197|170|I|right away if you have symptoms of high or low blood sugar. (See||
1197|171|I|also Side Effects section.) Your doctor may need to adjust your||
1197|172|I|diabetes medication, exercise program, or diet.||
1197|173|B|||
1197|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1197|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1197|176|O|poison control center right away. US residents can call||
1197|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1197|178|O|Symptoms of overdose may include: signs of low blood sugar such||
1197|179|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
1197|180|B|||
1197|181|N|NOTES:  Do not share this medication, needles, or syringes with||
1197|182|N|others.||
1197|183|N|   Attend a diabetes education program to learn more about how to||
1197|184|N|manage your diabetes with medications, diet, exercise, and||
1197|185|N|regular medical exams.||
1197|186|N|   Learn the symptoms of high and low blood sugar and how to||
1197|187|N|treat low blood sugar. Check your blood sugar regularly as||
1197|188|N|directed and share the results with your doctor.||
1197|189|N|   Lab and/or medical tests (such as liver/kidney function,||
1197|190|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
1197|191|N|should be done while you are taking this medication. Keep all||
1197|192|N|medical and lab appointments.||
1197|193|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
1197|194|B|||
1197|195|D|MISSED DOSE:  It is very important to follow your insulin regimen||
1197|196|D|exactly. Ask your doctor ahead of time what you should do if you||
1197|197|D|miss a dose of insulin.||
1197|198|B|||
1197|199|R|STORAGE:  Store all unopened insulin products in the||
1197|200|R|refrigerator. Opened concentrated insulin regular vials may be||
1197|201|R|stored in the refrigerator or at room temperature. Throw away the||
1197|202|R|concentrated insulin regular vials in use after 40 days, even if||
1197|203|R|there is insulin left. Opened concentrated insulin regular||
1197|204|R|prefilled pens can only be stored at room temperature and should||
1197|205|R|not be refrigerated. Throw away the prefilled pens in use after||
1197|206|R|28 days, even if there is insulin left. Also throw away all||
1197|207|R|insulin products after the expiration date on the package. Do not||
1197|208|R|freeze and do not use insulin that has been frozen.||
1197|209|R|   Protect insulin from light and heat. Do not store in the||
1197|210|R|bathroom. Keep all medications away from children and pets.||
1197|211|R|   Do not flush medications down the toilet or pour them into a||
1197|212|R|drain unless instructed to do so. Properly discard this product||
1197|213|R|when it is expired or no longer needed. Consult your pharmacist||
1197|214|R|or local waste disposal company.||
1197|215|B|||
1197|216|M|MEDICAL ALERT:  Your condition can cause complications in a||
1197|217|M|medical emergency. For information about enrolling in MedicAlert,||
1197|218|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1197|219|B|||
1197|220|A|Information last revised April 2025.||
1197|221|A|Copyright(c) 2025 First Databank, Inc.||
1197|222|B|||
1198|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1198|002|Z|does NOT have all possible information about this product. This||
1198|003|Z|information does not assure that this product is safe, effective,||
1198|004|Z|or appropriate for you. This information is not individual||
1198|005|Z|medical advice and does not substitute for the advice of your||
1198|006|Z|health care professional. Always ask your health care||
1198|007|Z|professional for complete information about this product and your||
1198|008|Z|specific health needs.||
1198|009|B|||
1198|010|T|MESALAMINE (5-AMINOSALICYLIC ACID) 24-HR EXTENDED-RELEASE - ORAL||
1198|011|F|(me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id)||
1198|012|B|||
1198|013|C|COMMON BRAND NAME(S): Apriso||
1198|014|B|||
1198|015|U|USES:  This medication is used to treat a certain bowel disease||
1198|016|U|(ulcerative colitis). It helps to reduce symptoms of ulcerative||
1198|017|U|colitis such as diarrhea, rectal bleeding, and stomach pain.||
1198|018|U|Mesalamine belongs to a class of drugs known as aminosalicylates.||
1198|019|U|It works by decreasing swelling in the colon.||
1198|020|B|||
1198|021|V|OTHER USES:  This section contains uses of this drug that are not||
1198|022|V|listed in the approved professional labeling for the drug but||
1198|023|V|that may be prescribed by your health care professional. Use this||
1198|024|V|drug for a condition that is listed in this section only if it||
1198|025|V|has been so prescribed by your health care professional.||
1198|026|V|   This drug may also be used for Crohn's disease.||
1198|027|B|||
1198|028|H|HOW TO USE:  Take this medication by mouth with or without food||
1198|029|H|as directed by your doctor, usually once daily in the morning.||
1198|030|H|   Swallow the capsules whole. Do not chew or crush the capsules||
1198|031|H|or take the drug with antacids. Doing so can keep the drug from||
1198|032|H|being released properly into the colon.||
1198|033|H|   Drink plenty of fluids during treatment with this medication||
1198|034|H|unless otherwise directed by your doctor. This will help prevent||
1198|035|H|kidney stones.||
1198|036|H|   Use this medication regularly to get the most benefit from it.||
1198|037|H|To help you remember, take it at the same time each day.||
1198|038|H|   Tell your doctor if your condition does not get better or if||
1198|039|H|it gets worse.||
1198|040|B|||
1198|041|S|SIDE EFFECTS:  Headache or abdominal pain may occur. If either of||
1198|042|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1198|043|S|promptly.||
1198|044|S|   Remember that this medication has been prescribed because your||
1198|045|S|doctor has judged that the benefit to you is greater than the||
1198|046|S|risk of side effects. Many people using this medication do not||
1198|047|S|have serious side effects.||
1198|048|S|   Rarely, mesalamine can worsen ulcerative colitis. Tell your||
1198|049|S|doctor right away if your symptoms worsen after starting this||
1198|050|S|medication (such as increased abdominal pain/cramping, bloody||
1198|051|S|diarrhea).||
1198|052|S|   Tell your doctor right away if you have any serious side||
1198|053|S|effects, including: nausea/vomiting that doesn't stop, signs of||
1198|054|S|kidney problems (such as change in the amount of urine, blood in||
1198|055|S|the urine), dark urine, severe stomach/abdominal pain, yellowing||
1198|056|S|eyes/skin, chest pain, shortness of breath.||
1198|057|S|   A very serious allergic reaction to this drug is rare.||
1198|058|S|However, get medical help right away if you notice any symptoms||
1198|059|S|of a serious allergic reaction, including: fever, swollen lymph||
1198|060|S|nodes, rash, itching/swelling (especially of the||
1198|061|S|face/tongue/throat), severe dizziness, trouble breathing.||
1198|062|S|   This is not a complete list of possible side effects. If you||
1198|063|S|notice other effects not listed above, contact your doctor or||
1198|064|S|pharmacist.||
1198|065|S|   In the US -||
1198|066|S|   Call your doctor for medical advice about side effects. You||
1198|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1198|068|S|www.fda.gov/medwatch.||
1198|069|S|   In Canada - Call your doctor for medical advice about side||
1198|070|S|effects. You may report side effects to Health Canada at||
1198|071|S|1-866-234-2345.||
1198|072|B|||
1198|073|P|PRECAUTIONS:  Before taking mesalamine, tell your doctor or||
1198|074|P|pharmacist if you are allergic to it; or to other||
1198|075|P|aminosalicylates (such as balsalazide, olsalazine); or to||
1198|076|P|salicylates (such as aspirin, salsalate); or to sulfasalazine; or||
1198|077|P|if you have any other allergies. This product may contain||
1198|078|P|inactive ingredients, which can cause allergic reactions or other||
1198|079|P|problems. Talk to your pharmacist for more details.||
1198|080|P|   Before using this medication, tell your doctor or pharmacist||
1198|081|P|your medical history, especially of: kidney disease, liver||
1198|082|P|disease, stomach blockage (such as pyloric stenosis).||
1198|083|P|   This medication may make you more sensitive to the sun,||
1198|084|P|especially if you have skin problems (such as atopic dermatitis,||
1198|085|P|eczema). Limit your time in the sun. Avoid tanning booths and||
1198|086|P|sunlamps. Use sunscreen and wear protective clothing when||
1198|087|P|outdoors. Tell your doctor right away if you get sunburned or||
1198|088|P|have skin blisters/redness.||
1198|089|P|   Before having surgery, tell your doctor or dentist about all||
1198|090|P|the products you use (including prescription drugs,||
1198|091|P|nonprescription drugs, and herbal products).||
1198|092|P|   This medication may contain aspartame. If you have||
1198|093|P|phenylketonuria (PKU) or any other condition that requires you to||
1198|094|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
1198|095|P|doctor or pharmacist about using this medication safely.||
1198|096|P|   This medication is similar to aspirin. Children and teenagers||
1198|097|P|younger than 18 years should not take aspirin or aspirin-related||
1198|098|P|medications (such as salicylates) if they have chickenpox, flu,||
1198|099|P|or any undiagnosed illness, or if they have recently received a||
1198|100|P|vaccine. In these cases, taking aspirin increases the risk of||
1198|101|P|Reye's syndrome, a rare but serious illness.||
1198|102|P|   During pregnancy, this medication should be used only when||
1198|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
1198|104|P|   This medication passes into breast milk and may have||
1198|105|P|undesirable effects on a nursing infant. Consult your doctor||
1198|106|P|before breastfeeding.||
1198|107|B|||
1198|108|I|DRUG INTERACTIONS:  See also How to Use section.||
1198|109|I|   Drug interactions may change how your medications work or||
1198|110|I|increase your risk for serious side effects. This document does||
1198|111|I|not contain all possible drug interactions. Keep a list of all||
1198|112|I|the products you use (including prescription/nonprescription||
1198|113|I|drugs and herbal products) and share it with your doctor and||
1198|114|I|pharmacist. Do not start, stop, or change the dosage of any||
1198|115|I|medicines without your doctor's approval.||
1198|116|I|   Mesalamine is very similar to balsalazide, olsalazine, and||
1198|117|I|sulfasalazine. Do not use medications containing balsalazide,||
1198|118|I|olsalazine, or sulfasalazine while using mesalamine.||
1198|119|I|   This medication may interfere with certain lab tests (such as||
1198|120|I|urine normetanephrine levels), possibly causing false test||
1198|121|I|results. Make sure lab personnel and all your doctors know you||
1198|122|I|use this drug.||
1198|123|B|||
1198|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1198|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1198|126|O|poison control center right away. US residents can call||
1198|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1198|128|O|Symptoms of overdose may include: ringing in the ears, confusion,||
1198|129|O|rapid breathing, seizures.||
1198|130|B|||
1198|131|N|NOTES:  Do not share this medication with others.||
1198|132|N|   Lab and/or medical tests (such as liver/kidney function) may||
1198|133|N|be done before you start taking this medication and while you are||
1198|134|N|taking it. Keep all medical and lab appointments. Consult your||
1198|135|N|doctor for more details.||
1198|136|B|||
1198|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1198|138|D|remember. If it is near the time of the next dose, skip the||
1198|139|D|missed dose. Take your next dose at the regular time. Do not||
1198|140|D|double the dose to catch up.||
1198|141|B|||
1198|142|R|STORAGE:  Store at room temperature away from light and moisture.||
1198|143|R|Do not store in the bathroom. Keep all medications away from||
1198|144|R|children and pets.||
1198|145|R|   Do not flush medications down the toilet or pour them into a||
1198|146|R|drain unless instructed to do so. Properly discard this product||
1198|147|R|when it is expired or no longer needed. Consult your pharmacist||
1198|148|R|or local waste disposal company.||
1198|149|B|||
1198|150|A|Information last revised October 2024.||
1198|151|A|Copyright(c) 2025 First Databank, Inc.||
1198|152|B|||
1199|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1199|002|Z|does NOT have all possible information about this product. This||
1199|003|Z|information does not assure that this product is safe, effective,||
1199|004|Z|or appropriate for you. This information is not individual||
1199|005|Z|medical advice and does not substitute for the advice of your||
1199|006|Z|health care professional. Always ask your health care||
1199|007|Z|professional for complete information about this product and your||
1199|008|Z|specific health needs.||
1199|009|B|||
1199|010|T|LAMOTRIGINE DISINTEGRATING TABLET - ORAL||
1199|011|F|(lam-OH-try-jeen)||
1199|012|B|||
1199|013|C|COMMON BRAND NAME(S): Lamictal ODT||
1199|014|B|||
1199|015|W|WARNING:  Rarely, serious (sometimes fatal) skin rashes have||
1199|016|W|occurred while taking this medication. These rashes are more||
1199|017|W|common in children than in adults. Rashes may be more likely if||
1199|018|W|you start at too high a dose, if you increase your dose too||
1199|019|W|quickly, or if you take this medication with certain other||
1199|020|W|anti-seizure medications (valproic acid, divalproex). These||
1199|021|W|rashes may occur anytime during use, but most serious rashes have||
1199|022|W|occurred within 2 to 8 weeks of starting lamotrigine.||
1199|023|W|   Get medical help right away if you develop any type of skin||
1199|024|W|rash, or if you have other signs of a serious allergic reaction||
1199|025|W|such as hives, fever, swollen lymph nodes, severe dizziness,||
1199|026|W|painful sores in the mouth or around the eyes, swelling of the||
1199|027|W|face/tongue/throat, trouble breathing, or liver problems||
1199|028|W|(symptoms include stomach/abdominal pain, nausea/vomiting that||
1199|029|W|continues, dark urine, yellowing eyes/skin). Your doctor will||
1199|030|W|tell you if you should stop taking lamotrigine. Even after you||
1199|031|W|stop taking this, it is still possible for a rash to become||
1199|032|W|life-threatening or cause permanent scars or other problems.||
1199|033|B|||
1199|034|U|USES:  Lamotrigine is used alone or with other medications to||
1199|035|U|prevent or control seizures (epilepsy). It may also be used to||
1199|036|U|help prevent the extreme mood swings of bipolar disorder in||
1199|037|U|adults.||
1199|038|U|   This drug is not approved for use in children younger than 2||
1199|039|U|years due to an increased risk of side effects (such as||
1199|040|U|infections).||
1199|041|B|||
1199|042|V|OTHER USES:  This section contains uses of this drug that are not||
1199|043|V|listed in the approved professional labeling for the drug but||
1199|044|V|that may be prescribed by your health care professional. Use this||
1199|045|V|drug for a condition that is listed in this section only if it||
1199|046|V|has been so prescribed by your health care professional.||
1199|047|V|   This medication may also be used for nerve pain.||
1199|048|B|||
1199|049|H|HOW TO USE:  Read the Medication Guide provided by your||
1199|050|H|pharmacist before you start taking lamotrigine and each time you||
1199|051|H|get a refill. If you have any questions, ask your doctor or||
1199|052|H|pharmacist.||
1199|053|H|   Take this medication with or without food as directed by your||
1199|054|H|doctor, usually 1 to 2 times daily. Place the tablet on your||
1199|055|H|tongue and move it around the mouth. Allow it to dissolve, and||
1199|056|H|swallow with or without water, or use as directed by your doctor.||
1199|057|H|If this medication comes in a blister pack, do not use the||
1199|058|H|medication if the blisters are torn, broken, or missing.||
1199|059|H|   The dosage is based on your medical condition, response to||
1199|060|H|treatment, and other medications you may be taking. Children's||
1199|061|H|dosage is also based on weight. Be sure to tell your doctor and||
1199|062|H|pharmacist about all the products you use (including prescription||
1199|063|H|drugs, nonprescription drugs, and herbal products).||
1199|064|H|   It is very important to follow your doctor's dosing||
1199|065|H|instructions exactly. The dose must be increased slowly. It may||
1199|066|H|take several weeks or months to reach the best dose for you and||
1199|067|H|to get the full benefit from this medication. Use this medication||
1199|068|H|regularly in order to get the most benefit from it. To help you||
1199|069|H|remember, use it at the same time(s) each day.||
1199|070|H|   Do not stop taking this medication without consulting your||
1199|071|H|doctor. Some conditions may become worse when the drug is||
1199|072|H|suddenly stopped. Your dose may need to be gradually decreased.||
1199|073|H|Also, if you have stopped taking this medication, do not restart||
1199|074|H|lamotrigine without consulting your doctor.||
1199|075|H|   Tell your doctor if your condition does not get better or if||
1199|076|H|it gets worse.||
1199|077|B|||
1199|078|S|SIDE EFFECTS:  See also Warning section.||
1199|079|S|   Dizziness, drowsiness, headache, vomiting, or upset stomach||
1199|080|S|may occur. If any of these effects last or get worse, tell your||
1199|081|S|doctor or pharmacist promptly.||
1199|082|S|   Remember that this medication has been prescribed because your||
1199|083|S|doctor has judged that the benefit to you is greater than the||
1199|084|S|risk of side effects. Many people using this medication do not||
1199|085|S|have serious side effects.||
1199|086|S|   A small number of people who take anticonvulsants for any||
1199|087|S|condition (such as seizure, bipolar disorder, pain) may||
1199|088|S|experience depression, suicidal thoughts/attempts, or other||
1199|089|S|mental/mood problems. Tell your doctor right away if you or your||
1199|090|S|family/caregiver notice any unusual/sudden changes in your mood,||
1199|091|S|thoughts, or behavior including signs of depression, suicidal||
1199|092|S|thoughts/attempts, thoughts about harming yourself.||
1199|093|S|   Get medical help right away if you have any very serious side||
1199|094|S|effects, including: fainting, fast/slow/irregular/pounding||
1199|095|S|heartbeat, easy or unusual bruising/bleeding, stiff neck, vision||
1199|096|S|problems, loss of coordination, muscle pain/tenderness/weakness,||
1199|097|S|signs of kidney problems (such as change in the amount of urine).||
1199|098|S|   This is not a complete list of possible side effects. If you||
1199|099|S|notice other effects not listed above, contact your doctor or||
1199|100|S|pharmacist.||
1199|101|S|   In the US -||
1199|102|S|   Call your doctor for medical advice about side effects. You||
1199|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1199|104|S|www.fda.gov/medwatch.||
1199|105|S|   In Canada - Call your doctor for medical advice about side||
1199|106|S|effects. You may report side effects to Health Canada at||
1199|107|S|1-866-234-2345.||
1199|108|B|||
1199|109|P|PRECAUTIONS:  Before taking lamotrigine, tell your doctor or||
1199|110|P|pharmacist if you are allergic to it; or if you have any other||
1199|111|P|allergies. This product may contain inactive ingredients, which||
1199|112|P|can cause allergic reactions or other problems. Talk to your||
1199|113|P|pharmacist for more details.||
1199|114|P|   Before using this medication, tell your doctor or pharmacist||
1199|115|P|your medical history, especially of: kidney disease, liver||
1199|116|P|disease, heart problems (such as irregular heartbeat, heart||
1199|117|P|block, heart failure).||
1199|118|P|   This drug may make you dizzy or drowsy or blur your vision.||
1199|119|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1199|120|P|drowsy. Do not drive, use machinery, or do anything that needs||
1199|121|P|alertness or clear vision until you can do it safely. Limit||
1199|122|P|alcoholic beverages. Talk to your doctor if you are using||
1199|123|P|marijuana (cannabis).||
1199|124|P|   Children may be at greater risk for skin rashes while taking||
1199|125|P|this drug. See also Warning section.||
1199|126|P|   Older adults may be more sensitive to the side effects of this||
1199|127|P|drug, especially dizziness, loss of coordination, or fainting.||
1199|128|P|These side effects can increase the risk of falling.||
1199|129|P|   During pregnancy, this medication should be used only when||
1199|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
1199|131|P|   This drug passes into breast milk and may have undesirable||
1199|132|P|effects on a nursing infant. Consult your doctor before||
1199|133|P|breastfeeding.||
1199|134|B|||
1199|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1199|136|I|medications work or increase your risk for serious side effects.||
1199|137|I|This document does not contain all possible drug interactions.||
1199|138|I|Keep a list of all the products you use (including||
1199|139|I|prescription/nonprescription drugs and herbal products) and share||
1199|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
1199|141|I|the dosage of any medicines without your doctor's approval.||
1199|142|I|   Some products that may interact with this drug include:||
1199|143|I|dofetilide, orlistat.||
1199|144|I|   Other medications can affect the removal of lamotrigine from||
1199|145|I|your body, which may affect how lamotrigine works. Examples||
1199|146|I|include hormonal birth control (such as pills, patches),||
1199|147|I|estrogens, other medications to treat seizures (such as||
1199|148|I|phenobarbital, primidone, valproic acid), rifampin, ritonavir,||
1199|149|I|among others. Your doctor may need to adjust your dose of||
1199|150|I|lamotrigine if you are on these medications. If you are using||
1199|151|I|hormonal birth control or estrogens, tell your doctor right away||
1199|152|I|of any changes in your menstrual pattern (such as breakthrough||
1199|153|I|bleeding).||
1199|154|I|   This medication may decrease the effectiveness of hormonal||
1199|155|I|birth control such as pills, patch, or ring. This could cause||
1199|156|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1199|157|I|use reliable backup birth control methods while using this||
1199|158|I|medication. Also tell your doctor if you have any new spotting or||
1199|159|I|breakthrough bleeding, because these may be signs that your birth||
1199|160|I|control is not working well.||
1199|161|I|   Tell your doctor or pharmacist if you are taking other||
1199|162|I|products that cause drowsiness, including alcohol, marijuana||
1199|163|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1199|164|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1199|165|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1199|166|I|codeine).||
1199|167|I|   Check the labels on all your medicines (such as allergy or||
1199|168|I|cough-and-cold products) because they may contain ingredients||
1199|169|I|that cause drowsiness. Ask your pharmacist about using those||
1199|170|I|products safely.||
1199|171|I|   This medication may interfere with certain lab tests (such as||
1199|172|I|urine drug screening tests), possibly causing false test results.||
1199|173|I|Make sure lab personnel and all your doctors know you use this||
1199|174|I|drug.||
1199|175|B|||
1199|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1199|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1199|178|O|poison control center right away. US residents can call||
1199|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1199|180|O|Symptoms of overdose may include: severe drowsiness, unusual eye||
1199|181|O|movements (nystagmus), loss of consciousness.||
1199|182|B|||
1199|183|N|NOTES:  Do not share this medication with others.||
1199|184|N|   Lab and/or medical tests (such as liver/kidney function,||
1199|185|N|complete blood count) may be done while you are taking this||
1199|186|N|medication. Keep all medical and lab appointments. Consult your||
1199|187|N|doctor for more details.||
1199|188|N|   There are different types of this medication available. Some||
1199|189|N|do not have the same effects. There are also some medications||
1199|190|N|that sound the same as this product. Make sure you have the right||
1199|191|N|product before taking it.||
1199|192|B|||
1199|193|D|MISSED DOSE:  It is important to take each dose at the scheduled||
1199|194|D|time. If you miss a dose, take it as soon as you remember. If it||
1199|195|D|is near the time of the next dose, skip the missed dose. Take||
1199|196|D|your next dose at the regular time. Do not double the dose to||
1199|197|D|catch up.||
1199|198|B|||
1199|199|R|STORAGE:  Store at room temperature away from heat, light and||
1199|200|R|moisture. Do not store in the bathroom. Keep all medications away||
1199|201|R|from children and pets.||
1199|202|R|   Do not flush medications down the toilet or pour them into a||
1199|203|R|drain unless instructed to do so. Properly discard this product||
1199|204|R|when it is expired or no longer needed. Consult your pharmacist||
1199|205|R|or local waste disposal company.||
1199|206|B|||
1199|207|M|MEDICAL ALERT:  Your condition can cause complications in a||
1199|208|M|medical emergency. For information about enrolling in MedicAlert,||
1199|209|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1199|210|B|||
1199|211|A|Information last revised October 2024.||
1199|212|A|Copyright(c) 2025 First Databank, Inc.||
1199|213|B|||
1200|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1200|002|Z|does NOT have all possible information about this product. This||
1200|003|Z|information does not assure that this product is safe, effective,||
1200|004|Z|or appropriate for you. This information is not individual||
1200|005|Z|medical advice and does not substitute for the advice of your||
1200|006|Z|health care professional. Always ask your health care||
1200|007|Z|professional for complete information about this product and your||
1200|008|Z|specific health needs.||
1200|009|B|||
1200|010|T|GOLIMUMAB - SUBCUTANEOUS INJECTION||
1200|011|F|(goe-LIM-ue-mab)||
1200|012|B|||
1200|013|C|COMMON BRAND NAME(S): Simponi||
1200|014|B|||
1200|015|W|WARNING:  This medication can decrease your body's ability to||
1200|016|W|fight an infection. This effect can lead to very serious||
1200|017|W|(possibly fatal) infections (such as fungal infections, bacterial||
1200|018|W|infections including tuberculosis). Tell your doctor your medical||
1200|019|W|history, especially of past/recent/current infections. You should||
1200|020|W|also tell your doctor if you have lived or traveled in areas||
1200|021|W|where certain fungal infections (such as coccidioidomycosis,||
1200|022|W|histoplasmosis) are common or if you have been near someone with||
1200|023|W|tuberculosis. Areas where these types of fungal infections are||
1200|024|W|commonly found include the Ohio and Mississippi River valleys and||
1200|025|W|the southwestern United States.||
1200|026|W|   Your doctor will test you for tuberculosis (TB) infection||
1200|027|W|before and during treatment with this drug. If you are diagnosed||
1200|028|W|with TB, your doctor will first prescribe treatment for this to||
1200|029|W|prevent a serious TB infection while using golimumab.||
1200|030|W|   Though it is very unlikely to happen, there is a risk||
1200|031|W|(especially in children/teens/young adults) of developing cancer||
1200|032|W|(such as lymphoma, skin cancer) due to this medication or due to||
1200|033|W|your medical condition. Discuss the risks and benefits of||
1200|034|W|treatment with your doctor. Tell your doctor right away if you||
1200|035|W|develop symptoms such as fever that doesn't go away, unusual||
1200|036|W|lumps/growths, swollen lymph nodes, unexplained weight loss, or||
1200|037|W|night sweats.||
1200|038|B|||
1200|039|U|USES:  This medication is used to reduce pain and swelling due to||
1200|040|U|certain types of arthritis (such as rheumatoid, psoriatic, and||
1200|041|U|ankylosing spondylitis). It works by blocking a protein (tumor||
1200|042|U|necrosis factor or TNF) found in the body's immune system that||
1200|043|U|causes joint swelling and damage. By reducing joint swelling, the||
1200|044|U|medication helps to reduce further joint damage and preserve||
1200|045|U|joint function. Depending on the type of arthritis that is being||
1200|046|U|treated, this drug may be used alone or in combination with||
1200|047|U|another drug called methotrexate.||
1200|048|U|   This medication is also used to treat a certain bowel||
1200|049|U|condition (ulcerative colitis). It is used to help lessen||
1200|050|U|symptoms of moderate to severe ulcerative colitis (such as||
1200|051|U|abdominal pain/cramping, diarrhea, bloody stools).||
1200|052|B|||
1200|053|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1200|054|H|provided by your pharmacist before you start using golimumab and||
1200|055|H|each time you get a refill. Ask your health care professional how||
1200|056|H|to prepare and use this medication. If you have any questions,||
1200|057|H|ask your doctor or pharmacist.||
1200|058|H|   Inject this medication under the skin as directed by your||
1200|059|H|doctor, usually once a month. The injection is given in the||
1200|060|H|thigh, abdomen, or upper arm. The dosage is based on your medical||
1200|061|H|condition. If you are using this medication to treat ulcerative||
1200|062|H|colitis, your doctor may prescribe a different schedule/higher||
1200|063|H|dose at the start of your treatment. Carefully follow your||
1200|064|H|doctor's directions for using this medication.||
1200|065|H|   Take the medication out of the refrigerator at least 30||
1200|066|H|minutes before you inject it to allow it to reach room||
1200|067|H|temperature. Do not warm up this medication any other way (for||
1200|068|H|example, do not heat it in the microwave or place it in hot||
1200|069|H|water). Do not shake the medication. This product may contain||
1200|070|H|tiny particles that are white or that you can see through. Before||
1200|071|H|using, check this product for cloudiness, large particles, or||
1200|072|H|discoloration. If you see any of these things, do not use the||
1200|073|H|liquid. Before injecting each dose, clean the skin you are going||
1200|074|H|to inject into (the injection site) with rubbing alcohol. Change||
1200|075|H|the injection site each time to lessen injury under the skin. Do||
1200|076|H|not inject into skin that is sore, bruised, red, scaly, or hard.||
1200|077|H|To lessen bruising, do not rub the injection site after a shot.||
1200|078|H|Learn how to store and discard medical supplies safely.||
1200|079|H|   Use this medication regularly to get the most benefit from it.||
1200|080|H|To help you remember, mark your calendar with a reminder.||
1200|081|H|   Tell your doctor if your condition lasts or gets worse.||
1200|082|B|||
1200|083|S|SIDE EFFECTS:  See also Warning section.||
1200|084|S|   Redness, itching, pain, or swelling at the injection site may||
1200|085|S|occur. If any of these effects last or get worse, tell your||
1200|086|S|doctor or pharmacist promptly.||
1200|087|S|   Remember that this medication has been prescribed because your||
1200|088|S|doctor has judged that the benefit to you is greater than the||
1200|089|S|risk of side effects. Many people using this medication do not||
1200|090|S|have serious side effects.||
1200|091|S|   Tell your doctor right away if you have any serious side||
1200|092|S|effects, including: easy bruising/bleeding, numbness/tingling of||
1200|093|S|the hands/feet, unsteadiness, unexplained muscle weakness, vision||
1200|094|S|changes, muscle/joint pain, butterfly-shaped rash on the nose and||
1200|095|S|cheeks, symptoms of heart failure (including shortness of breath,||
1200|096|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
1200|097|S|gain), signs of infection (such as sore throat that doesn't go||
1200|098|S|away, fever, chills, cough, unusual sweating), symptoms of liver||
1200|099|S|damage (including nausea/vomiting that doesn't stop, loss of||
1200|100|S|appetite, dark urine, stomach/abdominal pain, yellow eyes/skin).||
1200|101|S|   Get medical help right away if you have any very serious side||
1200|102|S|effects, including: chest pain, seizures.||
1200|103|S|   A very serious allergic reaction to this drug is rare.||
1200|104|S|However, get medical help right away if you notice any symptoms||
1200|105|S|of a serious allergic reaction, including: rash, itching/swelling||
1200|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1200|107|S|breathing.||
1200|108|S|   This is not a complete list of possible side effects. If you||
1200|109|S|notice other effects not listed above, contact your doctor or||
1200|110|S|pharmacist.||
1200|111|S|   In the US -||
1200|112|S|   Call your doctor for medical advice about side effects. You||
1200|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1200|114|S|www.fda.gov/medwatch.||
1200|115|S|   In Canada - Call your doctor for medical advice about side||
1200|116|S|effects. You may report side effects to Health Canada at||
1200|117|S|1-866-234-2345.||
1200|118|B|||
1200|119|P|PRECAUTIONS:  See also Warnings section.||
1200|120|P|   Before using golimumab, tell your doctor or pharmacist if you||
1200|121|P|are allergic to it; or if you have any other allergies. This||
1200|122|P|product may contain inactive ingredients (such as natural||
1200|123|P|rubber/latex), which can cause allergic reactions or other||
1200|124|P|problems. Talk to your pharmacist for more details.||
1200|125|P|   Before using this medication, tell your doctor or pharmacist||
1200|126|P|your medical history, especially of: blood/bone marrow problems||
1200|127|P|(such as low red/white blood cells and platelets), certain||
1200|128|P|brain/nerve disorders (such as multiple sclerosis, Guillain-Barre||
1200|129|P|syndrome), cancer, current/recent/repeated infections (such as||
1200|130|P|fungal, hepatitis B, tuberculosis), heart disease (such as heart||
1200|131|P|failure), lupus, seizures.||
1200|132|P|   Golimumab can make you more likely to get infections or may||
1200|133|P|make current infections worse. Stay away from anyone who has an||
1200|134|P|infection that may easily spread (such as chickenpox, COVID-19,||
1200|135|P|measles, flu). Talk to your doctor if you have been exposed to an||
1200|136|P|infection or for more details.||
1200|137|P|   Tell your health care professional that you are using||
1200|138|P|golimumab before having any immunizations/vaccinations. Avoid||
1200|139|P|contact with people who have recently received live vaccines||
1200|140|P|(such as flu vaccine inhaled through the nose).||
1200|141|P|   To lower the chance of getting cut, bruised, or injured, use||
1200|142|P|caution with sharp objects like razors and nail cutters, and||
1200|143|P|avoid activities such as contact sports.||
1200|144|P|   Before having surgery, tell your doctor or dentist about all||
1200|145|P|the products you use (including prescription drugs,||
1200|146|P|nonprescription drugs, and herbal products).||
1200|147|P|   Older adults may be more sensitive to the effects of this||
1200|148|P|drug, especially the risk of infections.||
1200|149|P|   During pregnancy, this medication should be used only when||
1200|150|P|clearly needed. Discuss the risks and benefits with your doctor.||
1200|151|P|Mothers who have used this medication during pregnancy should ask||
1200|152|P|a doctor about immunizations/vaccinations for their newborn||
1200|153|P|babies.||
1200|154|P|   This medication passes into breast milk. Consult your doctor||
1200|155|P|before breastfeeding.||
1200|156|B|||
1200|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1200|158|I|medications work or increase your risk for serious side effects.||
1200|159|I|This document does not contain all possible drug interactions.||
1200|160|I|Keep a list of all the products you use (including||
1200|161|I|prescription/nonprescription drugs and herbal products) and share||
1200|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
1200|163|I|the dosage of any medicines without your doctor's approval.||
1200|164|I|   Some products that may interact with this drug include: other||
1200|165|I|TNF-blockers (such as adalimumab, certolizumab, etanercept,||
1200|166|I|infliximab), other drugs that weaken the immune system (such as||
1200|167|I|abatacept, anakinra, cyclosporine).||
1200|168|I|   Avoid treatments that contain live bacteria or viruses (such||
1200|169|I|as BCG, flu vaccine inhaled through the nose) since they may||
1200|170|I|increase your risk for serious infections while you are using||
1200|171|I|golimumab.||
1200|172|B|||
1200|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1200|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1200|175|O|poison control center right away. US residents can call||
1200|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1200|177|B|||
1200|178|N|NOTES:  Do not share this medication with others.||
1200|179|N|   Lab and/or medical tests (such as complete blood counts, liver||
1200|180|N|function, skin exams) should be done while you are using this||
1200|181|N|medication. Keep all medical and lab appointments. Consult your||
1200|182|N|doctor for more details.||
1200|183|N|   This medication has been prescribed for your current condition||
1200|184|N|only. Do not use it later for another condition unless your||
1200|185|N|doctor directs you to do so. A different medication may be||
1200|186|N|necessary in that case.||
1200|187|B|||
1200|188|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
1200|189|D|right away for a new dosing schedule.||
1200|190|B|||
1200|191|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1200|192|R|medication in the original carton to protect from light. This||
1200|193|R|medication may also be stored at room temperature if needed. If||
1200|194|R|the medication is stored at room temperature, do not put it back||
1200|195|R|in the refrigerator and discard after 30 days. Discard any unused||
1200|196|R|portion after use. Keep all medications away from children and||
1200|197|R|pets.||
1200|198|R|   Do not flush medications down the toilet or pour them into a||
1200|199|R|drain unless instructed to do so. Properly discard this product||
1200|200|R|when it is expired or no longer needed. Consult your pharmacist||
1200|201|R|or local waste disposal company.||
1200|202|B|||
1200|203|M|MEDICAL ALERT:  Your condition can cause complications in a||
1200|204|M|medical emergency. For information about enrolling in MedicAlert,||
1200|205|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1200|206|B|||
1200|207|A|Information last revised November 2025.||
1200|208|A|Copyright(c) 2025 First Databank, Inc.||
1200|209|B|||
1201|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1201|002|Z|does NOT have all possible information about this product. This||
1201|003|Z|information does not assure that this product is safe, effective,||
1201|004|Z|or appropriate for you. This information is not individual||
1201|005|Z|medical advice and does not substitute for the advice of your||
1201|006|Z|health care professional. Always ask your health care||
1201|007|Z|professional for complete information about this product and your||
1201|008|Z|specific health needs.||
1201|009|B|||
1201|010|T|BESIFLOXACIN SUSPENSION - OPHTHALMIC||
1201|011|F|(BE-si-FLOX-a-sin)||
1201|012|B|||
1201|013|C|COMMON BRAND NAME(S): Besivance||
1201|014|B|||
1201|015|U|USES:  This medication is used to treat bacterial eye infections.||
1201|016|U|Besifloxacin belongs to a class of drugs known as quinolone||
1201|017|U|antibiotics. It works by stopping the growth of bacteria.||
1201|018|U|   This medication treats only bacterial eye infections. It will||
1201|019|U|not work for other types of eye infections (such as infections||
1201|020|U|caused by viruses, fungi, mycobacteria). Unnecessary use or||
1201|021|U|misuse of any antibiotic can lead to its decreased effectiveness.||
1201|022|B|||
1201|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1201|024|H|directed by your doctor, usually 3 times a day (with at least 4||
1201|025|H|hours or as many as 12 hours between each dose).||
1201|026|H|   To apply eye drops, wash hands first. To avoid contamination,||
1201|027|H|do not touch the dropper tip or let it touch your eye or any||
1201|028|H|other surface. Do not rinse the dropper. Replace the dropper cap||
1201|029|H|after each use.||
1201|030|H|   Do not wear contact lenses while you are using this medicine||
1201|031|H|or while you have the bacterial eye infection. Sterilize contact||
1201|032|H|lenses according to manufacturer's directions, and check with||
1201|033|H|your doctor before you begin using them again.||
1201|034|H|   Before use, hold the closed dropper bottle upside down and||
1201|035|H|shake once to mix. Tilt your head back, look upward, and pull||
1201|036|H|down the lower eyelid to make a pouch. Hold the dropper directly||
1201|037|H|over your eye and place 1 drop into the pouch. Look downward and||
1201|038|H|gently close your eyes for 1 to 2 minutes. Place a finger at the||
1201|039|H|corner of your eye (near the nose) and apply gentle pressure.||
1201|040|H|This will prevent the medication from draining out. Try not to||
1201|041|H|blink and do not rub your eye. Repeat these steps if your dose is||
1201|042|H|for more than 1 drop and for your other eye if so directed.||
1201|043|H|   Your dosage and length of treatment are based on your medical||
1201|044|H|condition and response to treatment.||
1201|045|H|   If you are using another kind of eye medication (such as drops||
1201|046|H|or ointments), wait at least 5 minutes before applying other||
1201|047|H|medications. Use eye drops before eye ointments to allow the||
1201|048|H|drops to enter the eye.||
1201|049|H|   Wait several minutes for your vision to clear before driving||
1201|050|H|or operating machinery.||
1201|051|H|   Use this medication regularly to get the most benefit from it.||
1201|052|H|To help you remember, use it at the same times each day. Continue||
1201|053|H|to use this medication for the full time prescribed, even if||
1201|054|H|symptoms disappear after a few days. Stopping the medication too||
1201|055|H|early may result in a return of the infection.||
1201|056|H|   Tell your doctor if your condition does not get better in a||
1201|057|H|few days or if you develop new or worsening eye symptoms (such as||
1201|058|H|discharge, swelling, redness, pain).||
1201|059|B|||
1201|060|S|SIDE EFFECTS:  Temporary eye redness/itching/pain or temporary||
1201|061|S|blurred vision may occur. If any of these effects last or get||
1201|062|S|worse, tell your doctor or pharmacist promptly.||
1201|063|S|   Remember that this medication has been prescribed because your||
1201|064|S|doctor has judged that the benefit to you is greater than the||
1201|065|S|risk of side effects. Many people using this medication do not||
1201|066|S|have serious side effects.||
1201|067|S|   A very serious allergic reaction to this drug is rare.||
1201|068|S|However, get medical help right away if you notice any symptoms||
1201|069|S|of a serious allergic reaction, including: rash, itching/swelling||
1201|070|S|(especially of the face/tongue/throat/eye/eyelid), severe||
1201|071|S|dizziness, trouble breathing.||
1201|072|S|   This is not a complete list of possible side effects. If you||
1201|073|S|notice other effects not listed above, contact your doctor or||
1201|074|S|pharmacist.||
1201|075|S|   In the US -||
1201|076|S|   Call your doctor for medical advice about side effects. You||
1201|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1201|078|S|www.fda.gov/medwatch.||
1201|079|S|   In Canada - Call your doctor for medical advice about side||
1201|080|S|effects. You may report side effects to Health Canada at||
1201|081|S|1-866-234-2345.||
1201|082|B|||
1201|083|P|PRECAUTIONS:  Before using besifloxacin, tell your doctor or||
1201|084|P|pharmacist if you are allergic to it; or to other quinolone||
1201|085|P|antibiotics (such as ciprofloxacin, norfloxacin); or if you have||
1201|086|P|any other allergies. This product may contain inactive||
1201|087|P|ingredients (such as preservatives like benzalkonium chloride),||
1201|088|P|which can cause allergic reactions or other problems. Talk to||
1201|089|P|your pharmacist for more details.||
1201|090|P|   Before using this medication, tell your doctor or pharmacist||
1201|091|P|your medical history.||
1201|092|P|   After you apply this drug, your vision may become temporarily||
1201|093|P|blurred. Do not drive, use machinery, or do anything that needs||
1201|094|P|clear vision until you can do it safely.||
1201|095|P|   During pregnancy, this medication should be used only when||
1201|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
1201|097|P|   It is unknown if this medication passes into breast milk.||
1201|098|P|Consult your doctor before breastfeeding.||
1201|099|B|||
1201|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1201|101|I|medications work or increase your risk for serious side effects.||
1201|102|I|This document does not contain all possible drug interactions.||
1201|103|I|Keep a list of all the products you use (including||
1201|104|I|prescription/nonprescription drugs and herbal products) and share||
1201|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
1201|106|I|the dosage of any medicines without your doctor's approval.||
1201|107|B|||
1201|108|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1201|109|O|has overdosed and has serious symptoms such as passing out or||
1201|110|O|trouble breathing, call 911. Otherwise, call a poison control||
1201|111|O|center right away. US residents can call 1-800-222-1222. Canada||
1201|112|O|residents can call 1-844-764-7669.||
1201|113|B|||
1201|114|N|NOTES:  Do not share this medication with others.||
1201|115|N|   This medication has been prescribed for your current condition||
1201|116|N|only. Throw away the unused medication after treatment is||
1201|117|N|completed. Do not use it later for another infection unless your||
1201|118|N|doctor tells you to.||
1201|119|B|||
1201|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1201|121|D|If it is near the time of the next dose, skip the missed dose.||
1201|122|D|Use your next dose at the regular time. Do not double the dose to||
1201|123|D|catch up.||
1201|124|B|||
1201|125|R|STORAGE:  Store at room temperature away from light. Keep all||
1201|126|R|medications away from children and pets.||
1201|127|R|   Do not flush medications down the toilet or pour them into a||
1201|128|R|drain unless instructed to do so. Properly discard this product||
1201|129|R|when it is expired or no longer needed. Consult your pharmacist||
1201|130|R|or local waste disposal company.||
1201|131|B|||
1201|132|A|Information last revised November 2024.||
1201|133|A|Copyright(c) 2025 First Databank, Inc.||
1201|134|B|||
1202|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1202|002|Z|does NOT have all possible information about this product. This||
1202|003|Z|information does not assure that this product is safe, effective,||
1202|004|Z|or appropriate for you. This information is not individual||
1202|005|Z|medical advice and does not substitute for the advice of your||
1202|006|Z|health care professional. Always ask your health care||
1202|007|Z|professional for complete information about this product and your||
1202|008|Z|specific health needs.||
1202|009|B|||
1202|010|T|POLYETHYLENE GLYCOL (PEG) 3350 - ORAL||
1202|011|F|(paw-lee-ETH-ih-leen GLY-coll)||
1202|012|B|||
1202|013|C|COMMON BRAND NAME(S): Miralax||
1202|014|B|||
1202|015|U|USES:  This medication is used to treat occasional constipation.||
1202|016|U|It works by holding water in the stool to soften the stool and||
1202|017|U|increases the number of bowel movements. It is known as an||
1202|018|U|osmotic-type laxative.||
1202|019|U|   This medication is also available without a prescription. If||
1202|020|U|you are taking this medication for self-treatment, it is||
1202|021|U|important to read the manufacturer's package instructions||
1202|022|U|carefully so you know when to consult your doctor or pharmacist.||
1202|023|U|(See also Precautions.)||
1202|024|B|||
1202|025|H|HOW TO USE:  Take this medication by mouth usually once daily, or||
1202|026|H|as directed by your doctor or the directions on the product||
1202|027|H|package.||
1202|028|H|   If you are prescribed the individual packets, mix the powder||
1202|029|H|as directed by your doctor or pharmacist. If you are using the||
1202|030|H|bulk bottle, use the provided cap to measure the prescribed dose.||
1202|031|H|Mix the powder with a glass (4-8 ounces/120-240 milliliters) of||
1202|032|H|liquid such as water, juice, soda, coffee, or tea. Before||
1202|033|H|drinking the solution, stir the powder well until it completely||
1202|034|H|dissolves. If you have any questions, ask your pharmacist.||
1202|035|H|   This medication may cause certain liquid thickeners||
1202|036|H|(starch-based products) to not work well, which may increase the||
1202|037|H|risk of choking. If you are using liquid thickeners with this||
1202|038|H|medication, talk to your pharmacist to select a liquid thickener||
1202|039|H|which will not interact with this medication.||
1202|040|H|   It may take 2 to 4 days after you have started this medication||
1202|041|H|to have a bowel movement. Do not increase your dose or take it||
1202|042|H|more often than prescribed. Also, do not use this medication for||
1202|043|H|more than 2 weeks unless directed by your doctor. Tell your||
1202|044|H|doctor if your condition lasts or gets worse. Extended use or||
1202|045|H|overuse may result in dependence on laxatives and chronic||
1202|046|H|constipation. Overuse may cause diarrhea, dehydration, and||
1202|047|H|mineral imbalance (such as low sodium).||
1202|048|H|   If you are using nonprescription polyethylene glycol for||
1202|049|H|self-treatment of occasional constipation and this treatment has||
1202|050|H|not worked after 7 days, talk to your doctor for additional||
1202|051|H|treatment advice.||
1202|052|B|||
1202|053|S|SIDE EFFECTS:  Nausea, abdominal cramping, or gas may occur. If||
1202|054|S|any of these effects last or get worse, tell your doctor or||
1202|055|S|pharmacist promptly.||
1202|056|S|   If your doctor has directed you to use this medication,||
1202|057|S|remember that your doctor has judged that the benefit to you is||
1202|058|S|greater than the risk of side effects. Many people using this||
1202|059|S|medication do not have serious side effects.||
1202|060|S|   Tell your doctor right away if you have diarrhea that doesn't||
1202|061|S|stop, stomach/abdominal pain that is severe or doesn't go away,||
1202|062|S|an excessive number of bowel movements, bloody stools, or rectal||
1202|063|S|bleeding while using this medication.||
1202|064|S|   A very serious allergic reaction to this drug is rare.||
1202|065|S|However, get medical help right away if you notice any symptoms||
1202|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1202|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1202|068|S|breathing.||
1202|069|S|   This is not a complete list of possible side effects. If you||
1202|070|S|notice other effects not listed above, contact your doctor or||
1202|071|S|pharmacist.||
1202|072|S|   In the US -||
1202|073|S|   Call your doctor for medical advice about side effects. You||
1202|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1202|075|S|www.fda.gov/medwatch.||
1202|076|S|   In Canada - Call your doctor for medical advice about side||
1202|077|S|effects. You may report side effects to Health Canada at||
1202|078|S|1-866-234-2345.||
1202|079|B|||
1202|080|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1202|081|P|pharmacist if you are allergic to polyethylene glycol; or if you||
1202|082|P|have any other allergies. This product may contain inactive||
1202|083|P|ingredients, which can cause allergic reactions or other||
1202|084|P|problems. Talk to your pharmacist for more details.||
1202|085|P|   Before using this medication, tell your doctor or pharmacist||
1202|086|P|your medical history, especially of: nausea/vomiting/abdominal||
1202|087|P|pain that doesn't go away, stomach/intestinal problems (such as||
1202|088|P|bowel obstruction, irritable bowel syndrome), kidney disease.||
1202|089|P|   Before having surgery, tell your doctor or dentist about all||
1202|090|P|the products you use (including prescription drugs,||
1202|091|P|nonprescription drugs, and herbal products).||
1202|092|P|   Older adults may be more sensitive to the side effects of this||
1202|093|P|drug, especially diarrhea.||
1202|094|P|   During pregnancy, this medication should be used only when||
1202|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1202|096|P|   It is unknown if this drug passes into breast milk. Consult||
1202|097|P|your doctor before breastfeeding.||
1202|098|B|||
1202|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1202|100|I|medications work or increase your risk for serious side effects.||
1202|101|I|This document does not contain all possible drug interactions.||
1202|102|I|Keep a list of all the products you use (including||
1202|103|I|prescription/nonprescription drugs and herbal products) and share||
1202|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1202|105|I|the dosage of any medicines without your doctor's approval.||
1202|106|B|||
1202|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1202|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1202|109|O|poison control center right away. US residents can call||
1202|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1202|111|O|Symptoms of overdose may include: severe diarrhea, dizziness,||
1202|112|O|decrease in the amount of urine.||
1202|113|B|||
1202|114|N|NOTES:  Do not share this medication with others.||
1202|115|N|   To prevent constipation, remember to exercise regularly, drink||
1202|116|N|adequate fluids, and eat fiber-rich foods such as bran, whole||
1202|117|N|grain, fresh fruits, and vegetables. Talk to your doctor or||
1202|118|N|pharmacist about lifestyle changes that might benefit you.||
1202|119|B|||
1202|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1202|121|D|If it is near the time of the next dose, skip the missed dose.||
1202|122|D|Use your next dose at the regular time. Do not double the dose to||
1202|123|D|catch up.||
1202|124|B|||
1202|125|R|STORAGE:  Store at room temperature away from light and moisture.||
1202|126|R|Do not store in the bathroom. Keep all medications away from||
1202|127|R|children and pets.||
1202|128|R|   Do not flush medications down the toilet or pour them into a||
1202|129|R|drain unless instructed to do so. Properly discard this product||
1202|130|R|when it is expired or no longer needed. Consult your pharmacist||
1202|131|R|or local waste disposal company.||
1202|132|B|||
1202|133|A|Information last revised May 2024.||
1202|134|A|Copyright(c) 2025 First Databank, Inc.||
1202|135|B|||
1203|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1203|002|Z|does NOT have all possible information about this product. This||
1203|003|Z|information does not assure that this product is safe, effective,||
1203|004|Z|or appropriate for you. This information is not individual||
1203|005|Z|medical advice and does not substitute for the advice of your||
1203|006|Z|health care professional. Always ask your health care||
1203|007|Z|professional for complete information about this product and your||
1203|008|Z|specific health needs.||
1203|009|B|||
1203|010|T|TOLVAPTAN - ORAL||
1203|011|F|(tol-VAP-tan)||
1203|012|B|||
1203|013|C|COMMON BRAND NAME(S): Samsca||
1203|014|B|||
1203|015|W|WARNING:  Treatment with this drug should be started or restarted||
1203|016|W|in a hospital for proper monitoring. If your level of sodium in||
1203|017|W|the blood is raised too quickly, it may cause a serious (even||
1203|018|W|fatal) condition called osmotic demyelination syndrome. The risk||
1203|019|W|is higher if you have liver disease, poor nutrition, or if you||
1203|020|W|use/abuse alcohol. Tell your doctor right away if you have||
1203|021|W|symptoms such as trouble speaking/swallowing, mental/mood changes||
1203|022|W|(such as confusion), weakness/involuntary movement in the||
1203|023|W|arms/legs, or seizures.||
1203|024|W|   Do not use this medication to treat a certain kidney problem||
1203|025|W|(autosomal dominant polycystic kidney disease-ADPKD). Due to the||
1203|026|W|risk of serious liver damage, you must be in a special program||
1203|027|W|for you to take this medication to treat ADPKD. Ask your doctor||
1203|028|W|for details.||
1203|029|B|||
1203|030|U|USES:  This medication is used to treat low levels of salt||
1203|031|U|(sodium) in the blood, which can result from conditions such as||
1203|032|U|heart failure and certain hormone imbalances. Tolvaptan belongs||
1203|033|U|to a class of drugs known as vasopressin receptor antagonists. It||
1203|034|U|works by increasing the amount of urine you make, causing your||
1203|035|U|body to get rid of extra water. This helps to slowly increase to||
1203|036|U|normal levels of salt in the blood.||
1203|037|U|   Different brands of this medication have different uses. Do||
1203|038|U|not change brands of this medication unless directed by your||
1203|039|U|doctor.||
1203|040|B|||
1203|041|H|HOW TO USE:  Read the Medication Guide provided by your||
1203|042|H|pharmacist before you start using tolvaptan and each time you get||
1203|043|H|a refill. If you have any questions, ask your doctor or||
1203|044|H|pharmacist.||
1203|045|H|   Take this medication by mouth with or without food as directed||
1203|046|H|by your doctor, usually once daily. You should not take this||
1203|047|H|medication for longer than 30 days.||
1203|048|H|   To prevent dehydration, always have water ready to drink while||
1203|049|H|taking tolvaptan. Drink when you are thirsty unless otherwise||
1203|050|H|directed by your doctor.||
1203|051|H|   Use this medication regularly to get the most benefit from it.||
1203|052|H|To help you remember, take it at the same time each day. Do not||
1203|053|H|stop and restart this medication on your own. You may need to go||
1203|054|H|back to a hospital to restart this medication. Tell your doctor||
1203|055|H|right away if you stop taking this medication for any reason.||
1203|056|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1203|057|H|using this medication unless your doctor or pharmacist says you||
1203|058|H|may do so safely. Grapefruit can increase the chance of side||
1203|059|H|effects with this medicine. Ask your doctor or pharmacist for||
1203|060|H|more details.||
1203|061|H|   The dosage is based on your medical condition and response to||
1203|062|H|treatment.||
1203|063|B|||
1203|064|S|SIDE EFFECTS:  See also Warning section.||
1203|065|S|   Thirst, dry mouth, loss of appetite, constipation, or weakness||
1203|066|S|may occur. If any of these effects last or get worse, tell your||
1203|067|S|doctor or pharmacist promptly.||
1203|068|S|   Remember that this medication has been prescribed because your||
1203|069|S|doctor has judged that the benefit to you is greater than the||
1203|070|S|risk of side effects. Many people using this medication do not||
1203|071|S|have serious side effects.||
1203|072|S|   Dehydration can occur. The risk is increased if you have||
1203|073|S|vomiting or diarrhea that doesn't stop, and you cannot drink||
1203|074|S|normally. Contact your doctor right away if you notice any||
1203|075|S|symptoms of dehydration, such as fast heartbeat or||
1203|076|S|dizziness/lightheadedness.||
1203|077|S|   People with severe liver disease (cirrhosis) may have||
1203|078|S|increased risk of bleeding from the stomach or intestines while||
1203|079|S|taking this medication. Tell your doctor right away if you have||
1203|080|S|any of the following symptoms: black/bloody stools, vomit that||
1203|081|S|contains blood or looks like coffee grounds.||
1203|082|S|   Tolvaptan may rarely cause serious (possibly fatal) liver||
1203|083|S|disease. Get medical help right away if you have any symptoms of||
1203|084|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
1203|085|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1203|086|S|urine.||
1203|087|S|   A very serious allergic reaction to this drug is rare.||
1203|088|S|However, get medical help right away if you notice any symptoms||
1203|089|S|of a serious allergic reaction, including: rash, itching/swelling||
1203|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1203|091|S|breathing.||
1203|092|S|   This is not a complete list of possible side effects. If you||
1203|093|S|notice other effects not listed above, contact your doctor or||
1203|094|S|pharmacist.||
1203|095|S|   In the US -||
1203|096|S|   Call your doctor for medical advice about side effects. You||
1203|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1203|098|S|www.fda.gov/medwatch.||
1203|099|S|   In Canada - Call your doctor for medical advice about side||
1203|100|S|effects. You may report side effects to Health Canada at||
1203|101|S|1-866-234-2345.||
1203|102|B|||
1203|103|P|PRECAUTIONS:  Before taking tolvaptan, tell your doctor or||
1203|104|P|pharmacist if you are allergic to it; or if you have any other||
1203|105|P|allergies. This product may contain inactive ingredients, which||
1203|106|P|can cause allergic reactions or other problems. Talk to your||
1203|107|P|pharmacist for more details.||
1203|108|P|   Before using this medication, tell your doctor or pharmacist||
1203|109|P|your medical history, especially of: diabetes, liver disease,||
1203|110|P|trouble urinating (such as due to enlarged prostate, blockage,||
1203|111|P|inability to make urine), use/abuse of alcohol.||
1203|112|P|   To prevent dehydration while taking this medication, you must||
1203|113|P|be able to replace fluids by drinking. Before taking this||
1203|114|P|medication, tell your doctor if you are not able to drink||
1203|115|P|normally or if you cannot feel if you are thirsty. (See also How||
1203|116|P|to Use section.)||
1203|117|P|   This medication may rarely make your blood sugar rise, which||
1203|118|P|can cause or worsen diabetes. If you have diabetes, check your||
1203|119|P|blood sugar regularly as directed and share the results with your||
1203|120|P|doctor. Your doctor may need to adjust your diabetes medication,||
1203|121|P|exercise program, or diet.||
1203|122|P|   Before having surgery, tell your doctor or dentist about all||
1203|123|P|the products you use (including prescription drugs,||
1203|124|P|nonprescription drugs, and herbal products).||
1203|125|P|   During pregnancy, this medication should be used only when||
1203|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
1203|127|P|   It is unknown if this medication passes into breast milk.||
1203|128|P|Consult your doctor before breastfeeding.||
1203|129|B|||
1203|130|I|DRUG INTERACTIONS:  See also How to Use section.||
1203|131|I|   Drug interactions may change how your medications work or||
1203|132|I|increase your risk for serious side effects. This document does||
1203|133|I|not contain all possible drug interactions. Keep a list of all||
1203|134|I|the products you use (including prescription/nonprescription||
1203|135|I|drugs and herbal products) and share it with your doctor and||
1203|136|I|pharmacist. Do not start, stop, or change the dosage of any||
1203|137|I|medicines without your doctor's approval.||
1203|138|I|   A product that may interact with this drug is: desmopressin.||
1203|139|I|   Other medications can affect the removal of tolvaptan from||
1203|140|I|your body, which may affect how tolvaptan works. Examples include||
1203|141|I|azole antifungals (such as ketoconazole, itraconazole),||
1203|142|I|cobicistat, HIV protease inhibitors (such as lopinavir),||
1203|143|I|macrolide antibiotics (such as clarithromycin, erythromycin),||
1203|144|I|ribociclib, rifamycins (such as rifabutin, rifampin), ritonavir,||
1203|145|I|St. John's wort, drugs used to treat seizures (such as||
1203|146|I|carbamazepine, phenytoin), among others.||
1203|147|B|||
1203|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1203|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1203|150|O|poison control center right away. US residents can call||
1203|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1203|152|B|||
1203|153|N|NOTES:  Do not share this medication with others.||
1203|154|N|   Lab and/or medical tests (such as levels of sodium/potassium||
1203|155|N|in the blood) should be done while you are taking this||
1203|156|N|medication. Keep all medical and lab appointments.||
1203|157|B|||
1203|158|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1203|159|D|remember. If it is near the time of the next dose, skip the||
1203|160|D|missed dose. Take your next dose at the regular time. Do not||
1203|161|D|double the dose to catch up.||
1203|162|B|||
1203|163|R|STORAGE:  Store at room temperature away from light and moisture.||
1203|164|R|Do not store in the bathroom. Keep all medications away from||
1203|165|R|children and pets.||
1203|166|R|   Do not flush medications down the toilet or pour them into a||
1203|167|R|drain unless instructed to do so. Properly discard this product||
1203|168|R|when it is expired or no longer needed. Consult your pharmacist||
1203|169|R|or local waste disposal company.||
1203|170|B|||
1203|171|A|Information last revised May 2024.||
1203|172|A|Copyright(c) 2025 First Databank, Inc.||
1203|173|B|||
1205|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1205|002|Z|does NOT have all possible information about this product. This||
1205|003|Z|information does not assure that this product is safe, effective,||
1205|004|Z|or appropriate for you. This information is not individual||
1205|005|Z|medical advice and does not substitute for the advice of your||
1205|006|Z|health care professional. Always ask your health care||
1205|007|Z|professional for complete information about this product and your||
1205|008|Z|specific health needs.||
1205|009|B|||
1205|010|T|LAMOTRIGINE EXTENDED-RELEASE - ORAL||
1205|011|F|(lam-OH-try-jeen)||
1205|012|B|||
1205|013|C|COMMON BRAND NAME(S): Lamictal XR||
1205|014|B|||
1205|015|W|WARNING:  Rarely, serious (sometimes fatal) skin rashes have||
1205|016|W|occurred while taking this medication. These rashes are more||
1205|017|W|common in children than in adults. Rashes may be more likely if||
1205|018|W|you start at too high a dose, if you increase your dose too||
1205|019|W|quickly, or if you take this medication with certain other||
1205|020|W|anti-seizure medications (valproic acid, divalproex). These||
1205|021|W|rashes may occur anytime during use, but most serious rashes have||
1205|022|W|occurred within 2 to 8 weeks of starting lamotrigine.||
1205|023|W|   Get medical help right away if you develop any type of skin||
1205|024|W|rash, or if you have other signs of a serious allergic reaction||
1205|025|W|such as hives, fever, swollen lymph nodes, severe dizziness,||
1205|026|W|painful sores in the mouth or around the eyes, swelling of the||
1205|027|W|face/tongue/throat, trouble breathing, or liver problems||
1205|028|W|(symptoms include stomach/abdominal pain, nausea/vomiting that||
1205|029|W|continues, dark urine, yellowing eyes/skin). Your doctor will||
1205|030|W|tell you if you should stop taking lamotrigine. Even after you||
1205|031|W|stop taking this, it is still possible for a rash to become||
1205|032|W|life-threatening or cause permanent scars or other problems.||
1205|033|B|||
1205|034|U|USES:  This product is used to prevent or control seizures||
1205|035|U|(epilepsy).||
1205|036|U|   This drug is not approved for use in children younger than 2||
1205|037|U|years due to an increased risk of side effects (such as||
1205|038|U|infections).||
1205|039|B|||
1205|040|V|OTHER USES:  This section contains uses of this drug that are not||
1205|041|V|listed in the approved professional labeling for the drug but||
1205|042|V|that may be prescribed by your health care professional. Use this||
1205|043|V|drug for a condition that is listed in this section only if it||
1205|044|V|has been so prescribed by your health care professional.||
1205|045|V|   This drug may also be used to reduce the risk of extreme mood||
1205|046|V|swings of bipolar disorder in adults.||
1205|047|B|||
1205|048|H|HOW TO USE:  Read the Medication Guide provided by your||
1205|049|H|pharmacist before you start taking lamotrigine and each time you||
1205|050|H|get a refill. If you have any questions, ask your doctor or||
1205|051|H|pharmacist.||
1205|052|H|   Take this medication with or without food as directed by your||
1205|053|H|doctor, usually once daily. Swallow the tablets whole. Do not||
1205|054|H|crush or chew the tablets. Doing so can release all of the drug||
1205|055|H|at once, increasing the risk of side effects.||
1205|056|H|   The dosage is based on your medical condition, response to||
1205|057|H|treatment, and other medications you may be taking. Be sure to||
1205|058|H|tell your doctor and pharmacist about all the products you use||
1205|059|H|(including prescription drugs, nonprescription drugs, and herbal||
1205|060|H|products). If you are being switched from the immediate release||
1205|061|H|form of this medication, your doctor will usually start you on a||
1205|062|H|dose similar to what you were taking with the immediate release||
1205|063|H|form.||
1205|064|H|   It is very important to follow your doctor's dosing||
1205|065|H|instructions exactly. The dose must be increased slowly. It may||
1205|066|H|take several weeks or months to reach the best dose for you and||
1205|067|H|to get the full benefit from this medication. Use this medication||
1205|068|H|regularly in order to get the most benefit from it. To help you||
1205|069|H|remember, use it at the same time each day.||
1205|070|H|   Do not stop taking this medication without consulting your||
1205|071|H|doctor. Some conditions may become worse when the drug is||
1205|072|H|suddenly stopped. Your dose may need to be gradually decreased.||
1205|073|H|Also, if you have stopped taking this medication, do not restart||
1205|074|H|lamotrigine without consulting your doctor.||
1205|075|H|   Tell your doctor if your condition does not get better or if||
1205|076|H|it gets worse.||
1205|077|B|||
1205|078|S|SIDE EFFECTS:  See also Warning section.||
1205|079|S|   Dizziness, drowsiness, headache, vomiting, or upset stomach||
1205|080|S|may occur. If any of these effects last or get worse, tell your||
1205|081|S|doctor or pharmacist promptly.||
1205|082|S|   Remember that this medication has been prescribed because your||
1205|083|S|doctor has judged that the benefit to you is greater than the||
1205|084|S|risk of side effects. Many people using this medication do not||
1205|085|S|have serious side effects.||
1205|086|S|   A small number of people who take anticonvulsants for any||
1205|087|S|condition (such as seizure, bipolar disorder, pain) may||
1205|088|S|experience depression, suicidal thoughts/attempts, or other||
1205|089|S|mental/mood problems. Tell your doctor right away if you or your||
1205|090|S|family/caregiver notice any unusual/sudden changes in your mood,||
1205|091|S|thoughts, or behavior including signs of depression, suicidal||
1205|092|S|thoughts/attempts, thoughts about harming yourself.||
1205|093|S|   Get medical help right away if you have any very serious side||
1205|094|S|effects, including: fainting, fast/slow/irregular/pounding||
1205|095|S|heartbeat, easy or unusual bruising/bleeding, stiff neck, vision||
1205|096|S|problems, loss of coordination, muscle pain/tenderness/weakness,||
1205|097|S|signs of kidney problems (such as change in the amount of urine).||
1205|098|S|   This is not a complete list of possible side effects. If you||
1205|099|S|notice other effects not listed above, contact your doctor or||
1205|100|S|pharmacist.||
1205|101|S|   In the US -||
1205|102|S|   Call your doctor for medical advice about side effects. You||
1205|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1205|104|S|www.fda.gov/medwatch.||
1205|105|S|   In Canada - Call your doctor for medical advice about side||
1205|106|S|effects. You may report side effects to Health Canada at||
1205|107|S|1-866-234-2345.||
1205|108|B|||
1205|109|P|PRECAUTIONS:  Before taking lamotrigine, tell your doctor or||
1205|110|P|pharmacist if you are allergic to it; or if you have any other||
1205|111|P|allergies. This product may contain inactive ingredients, which||
1205|112|P|can cause allergic reactions or other problems. Talk to your||
1205|113|P|pharmacist for more details.||
1205|114|P|   Before using this medication, tell your doctor or pharmacist||
1205|115|P|your medical history, especially of: kidney disease, liver||
1205|116|P|disease, heart problems (such as irregular heartbeat, heart||
1205|117|P|block, heart failure).||
1205|118|P|   This drug may make you dizzy or drowsy or blur your vision.||
1205|119|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1205|120|P|drowsy. Do not drive, use machinery, or do anything that needs||
1205|121|P|alertness or clear vision until you can do it safely. Limit||
1205|122|P|alcoholic beverages. Talk to your doctor if you are using||
1205|123|P|marijuana (cannabis).||
1205|124|P|   Children may be at greater risk for skin rashes while taking||
1205|125|P|this drug. See also Warning section.||
1205|126|P|   Older adults may be more sensitive to the side effects of this||
1205|127|P|drug, especially dizziness, loss of coordination, or fainting.||
1205|128|P|These side effects can increase the risk of falling.||
1205|129|P|   During pregnancy, this medication should be used only when||
1205|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
1205|131|P|   This drug passes into breast milk and may have undesirable||
1205|132|P|effects on a nursing infant. Consult your doctor before||
1205|133|P|breastfeeding.||
1205|134|B|||
1205|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1205|136|I|medications work or increase your risk for serious side effects.||
1205|137|I|This document does not contain all possible drug interactions.||
1205|138|I|Keep a list of all the products you use (including||
1205|139|I|prescription/nonprescription drugs and herbal products) and share||
1205|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
1205|141|I|the dosage of any medicines without your doctor's approval.||
1205|142|I|   Some products that may interact with this drug include:||
1205|143|I|dofetilide, orlistat.||
1205|144|I|   Other medications can affect the removal of lamotrigine from||
1205|145|I|your body, which may affect how lamotrigine works. Examples||
1205|146|I|include hormonal birth control (such as pills, patches),||
1205|147|I|estrogens, other medications to treat seizures (such as||
1205|148|I|phenobarbital, primidone, valproic acid), rifampin, ritonavir,||
1205|149|I|among others. Your doctor may need to adjust your dose of||
1205|150|I|lamotrigine if you are on these medications or if you stop these||
1205|151|I|medications. If you are using hormonal birth control or||
1205|152|I|estrogens, tell your doctor right away of any changes in your||
1205|153|I|menstrual pattern (such as breakthrough bleeding).||
1205|154|I|   This medication may decrease the effectiveness of hormonal||
1205|155|I|birth control such as pills, patch, or ring. This could cause||
1205|156|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1205|157|I|use reliable backup birth control methods while using this||
1205|158|I|medication. Also tell your doctor if you have any new spotting or||
1205|159|I|breakthrough bleeding, because these may be signs that your birth||
1205|160|I|control is not working well.||
1205|161|I|   Tell your doctor or pharmacist if you are taking other||
1205|162|I|products that cause drowsiness, including alcohol, marijuana||
1205|163|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1205|164|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1205|165|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1205|166|I|codeine).||
1205|167|I|   Check the labels on all your medicines (such as allergy or||
1205|168|I|cough-and-cold products) because they may contain ingredients||
1205|169|I|that cause drowsiness. Ask your pharmacist about using those||
1205|170|I|products safely.||
1205|171|I|   This medication may interfere with certain lab tests (such as||
1205|172|I|urine drug screening tests), possibly causing false test results.||
1205|173|I|Make sure lab personnel and all your doctors know you use this||
1205|174|I|drug.||
1205|175|B|||
1205|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1205|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1205|178|O|poison control center right away. US residents can call||
1205|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1205|180|O|Symptoms of overdose may include: severe drowsiness, unusual eye||
1205|181|O|movements (nystagmus), loss of consciousness.||
1205|182|B|||
1205|183|N|NOTES:  Do not share this medication with others.||
1205|184|N|   Lab and/or medical tests (such as liver/kidney function,||
1205|185|N|complete blood count) may be done while you are taking this||
1205|186|N|medication. Keep all medical and lab appointments. Consult your||
1205|187|N|doctor for more details.||
1205|188|N|   There are different types of this medication available. Some||
1205|189|N|do not have the same effects. There are also some medications||
1205|190|N|that sound the same as this product. Make sure you have the right||
1205|191|N|product before taking it.||
1205|192|B|||
1205|193|D|MISSED DOSE:  It is important to take each dose at the scheduled||
1205|194|D|time. If you miss a dose, take it as soon as you remember. If it||
1205|195|D|is near the time of the next dose, skip the missed dose. Take||
1205|196|D|your next dose at the regular time. Do not double the dose to||
1205|197|D|catch up.||
1205|198|B|||
1205|199|R|STORAGE:  Store at room temperature away from light and moisture.||
1205|200|R|Do not store in the bathroom. Keep all medications away from||
1205|201|R|children and pets.||
1205|202|R|   Do not flush medications down the toilet or pour them into a||
1205|203|R|drain unless instructed to do so. Properly discard this product||
1205|204|R|when it is expired or no longer needed. Consult your pharmacist||
1205|205|R|or local waste disposal company.||
1205|206|B|||
1205|207|M|MEDICAL ALERT:  Your condition can cause complications in a||
1205|208|M|medical emergency. For information about enrolling in MedicAlert,||
1205|209|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1205|210|B|||
1205|211|A|Information last revised October 2024.||
1205|212|A|Copyright(c) 2025 First Databank, Inc.||
1205|213|B|||
1207|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1207|002|Z|does NOT have all possible information about this product. This||
1207|003|Z|information does not assure that this product is safe, effective,||
1207|004|Z|or appropriate for you. This information is not individual||
1207|005|Z|medical advice and does not substitute for the advice of your||
1207|006|Z|health care professional. Always ask your health care||
1207|007|Z|professional for complete information about this product and your||
1207|008|Z|specific health needs.||
1207|009|B|||
1207|010|T|DIHYDROERGOTAMINE - INJECTION||
1207|011|F|(dye-HI-dro-er-GOT-uh-meen)||
1207|012|B|||
1207|013|C|COMMON BRAND NAME(S): Brekiya, D.H.E.45||
1207|014|B|||
1207|015|W|WARNING:  This medication has rarely caused a very serious lack||
1207|016|W|of blood flow to the hands and feet (peripheral ischemia) or to||
1207|017|W|the brain, which could cause a stroke. The risk is increased when||
1207|018|W|this medication is taken with other drugs that can affect the||
1207|019|W|removal of dihydroergotamine from your body. Examples include||
1207|020|W|azole antifungals (such as ketoconazole, itraconazole),||
1207|021|W|cobicistat, mifepristone, certain antidepressants (such as||
1207|022|W|nefazodone), macrolide antibiotics (such as clarithromycin,||
1207|023|W|erythromycin, troleandomycin), HIV protease inhibitors (such as||
1207|024|W|ritonavir, nelfinavir, indinavir), SSRIs (such as fluoxetine,||
1207|025|W|paroxetine, fluvoxamine), among others.||
1207|026|B|||
1207|027|U|USES:  Dihydroergotamine is used to treat migraine headaches and||
1207|028|U|cluster headaches. It is not recommended for migraines that||
1207|029|U|affect only one side of the brain (hemiplegic migraine) or the||
1207|030|U|base of the brain/neck area (basilar migraine), or to prevent||
1207|031|U|migraines from occurring.||
1207|032|U|   Dihydroergotamine is an ergot medication that helps narrow||
1207|033|U|widened blood vessels in the head, thereby reducing the throbbing||
1207|034|U|effects of these headaches.||
1207|035|B|||
1207|036|H|HOW TO USE:  Read the Medication Guide, Patient Information||
1207|037|H|Leaflet, and Instructions for Use if available from your||
1207|038|H|pharmacist before you start using dihydroergotamine and each time||
1207|039|H|you get a refill. If you have any questions, ask your doctor or||
1207|040|H|pharmacist.||
1207|041|H|   Depending on your product, this medication is given by||
1207|042|H|injection into a vein, into a muscle, or under the skin as||
1207|043|H|directed by your doctor. The dosage is based on your medical||
1207|044|H|condition and response to treatment. Usually, this medication||
1207|045|H|should be used only as needed. It is not meant for long-term||
1207|046|H|daily use. This medication works best if it is taken as the first||
1207|047|H|signs of the headache occur. If you wait until the headache has||
1207|048|H|worsened, the medication may not work as well.||
1207|049|H|   If your headache returns or you have no relief from the first||
1207|050|H|dose, you may repeat the dose 1 hour after the first dose, but||
1207|051|H|only if instructed to do so by your doctor.||
1207|052|H|   If this medication is given into a muscle or under the skin, a||
1207|053|H|third dose may be given 1 hour after the second dose if needed.||
1207|054|H|Do not use more than 3 milliliters in 24 hours or 6 milliliters||
1207|055|H|in a week.||
1207|056|H|   If this medication is given into a vein, do not use more than||
1207|057|H|2 milliliters in 24 hours or 6 milliliters in a week.||
1207|058|H|   If you are giving this medication to yourself at home, learn||
1207|059|H|all preparation and usage instructions from your health care||
1207|060|H|professional. Before using, check this product for particles or||
1207|061|H|discoloration. If either is present, do not use the liquid. Learn||
1207|062|H|how to store and discard medical supplies safely.||
1207|063|H|   Other "ergot" drugs (such as ergotamine, methysergide), or||
1207|064|H|"triptan-type" drugs (such as sumatriptan) should not be used||
1207|065|H|within 24 hours of this drug.||
1207|066|H|   If you are using drugs for migraine attacks on 10 or more days||
1207|067|H|each month, the drugs may actually make your headaches worse||
1207|068|H|(medication overuse headache). Do not use medications more often||
1207|069|H|or for longer than directed. Tell your doctor if you need to use||
1207|070|H|this medication more often, or if the medication is not working||
1207|071|H|as well, or if your headaches get worse.||
1207|072|B|||
1207|073|S|SIDE EFFECTS:  Dizziness, drowsiness, headache, nausea, vomiting,||
1207|074|S|diarrhea, flushing, or increased sweating may occur. If any of||
1207|075|S|these effects last or get worse, tell your doctor.||
1207|076|S|   Remember that this medication has been prescribed because your||
1207|077|S|doctor has judged that the benefit to you is greater than the||
1207|078|S|risk of side effects. Many people using this medication do not||
1207|079|S|have serious side effects.||
1207|080|S|   This medication may raise your blood pressure. Check your||
1207|081|S|blood pressure regularly and tell your doctor if the results are||
1207|082|S|high.||
1207|083|S|   Tell your doctor right away if you have any serious side||
1207|084|S|effects, including: slow/fast/irregular heartbeat,||
1207|085|S|tingling/pain/coldness in the fingers/toes, whitish||
1207|086|S|fingers/toes/nails, loss of feeling in the fingers/toes, bluish||
1207|087|S|hands/feet, muscle pain/weakness in the arms/legs, severe||
1207|088|S|stomach/abdominal pain, lower back pain, signs of kidney problems||
1207|089|S|(such as change in the amount of urine).||
1207|090|S|   Get medical help right away if you have any very serious side||
1207|091|S|effects, including: difficult/painful breathing, chest pain,||
1207|092|S|confusion, trouble speaking, weakness on one side of the body,||
1207|093|S|vision problems.||
1207|094|S|   A very serious allergic reaction to this drug is rare.||
1207|095|S|However, get medical help right away if you notice any symptoms||
1207|096|S|of a serious allergic reaction, including: rash, itching/swelling||
1207|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1207|098|S|breathing.||
1207|099|S|   This is not a complete list of possible side effects. If you||
1207|100|S|notice other effects not listed above, contact your doctor or||
1207|101|S|pharmacist.||
1207|102|S|   In the US -||
1207|103|S|   Call your doctor for medical advice about side effects. You||
1207|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1207|105|S|www.fda.gov/medwatch.||
1207|106|S|   In Canada - Call your doctor for medical advice about side||
1207|107|S|effects. You may report side effects to Health Canada at||
1207|108|S|1-866-234-2345.||
1207|109|B|||
1207|110|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1207|111|P|pharmacist if you are allergic to it; or to other ergot alkaloids||
1207|112|P|(such as ergotamine); or if you have any other allergies. This||
1207|113|P|product may contain inactive ingredients (such as latex found in||
1207|114|P|the needle cover of some brands), which can cause allergic||
1207|115|P|reactions or other problems. Talk to your pharmacist for more||
1207|116|P|details.||
1207|117|P|   Before using this medication, tell your doctor or pharmacist||
1207|118|P|your medical history, especially of: heart disease (such as chest||
1207|119|P|pain/angina, heart attack), high blood pressure, high||
1207|120|P|cholesterol, diabetes, smoking/tobacco use, family history of||
1207|121|P|heart disease, stroke, blood circulation disease (such as||
1207|122|P|peripheral arterial disease, Raynaud's disease), severe blood||
1207|123|P|infection (sepsis), stomach/intestinal problems (such as ischemic||
1207|124|P|bowel syndrome), kidney disease, liver disease, headaches with||
1207|125|P|unusual symptoms or certain types of headache||
1207|126|P|(hemiplegic/basilar), recent blood vessel surgery, permanent||
1207|127|P|ending of menstrual periods due to age/surgery/hormonal changes||
1207|128|P|(post-menopausal).||
1207|129|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1207|130|P|can make you more dizzy. Do not drive, use machinery, or do||
1207|131|P|anything that needs alertness until you can do it safely. Limit||
1207|132|P|alcoholic beverages. Talk to your doctor if you are using||
1207|133|P|marijuana (cannabis). Remember that alcohol may be a cause of||
1207|134|P|headaches.||
1207|135|P|   Using tobacco/nicotine products while using this medication||
1207|136|P|can increase the risk of serious side effects such as heart||
1207|137|P|problems (such as chest pain, fast/slow/irregular heartbeat) and||
1207|138|P|decreased blood supply to the brain/hands/feet. Do not use||
1207|139|P|tobacco while taking this medication. If you smoke, talk to your||
1207|140|P|doctor about how to stop smoking.||
1207|141|P|   Before having surgery, tell your doctor or dentist about all||
1207|142|P|the products you use (including prescription drugs,||
1207|143|P|nonprescription drugs, and herbal products).||
1207|144|P|   Tell your doctor if you are pregnant or plan to become||
1207|145|P|pregnant. You should not become pregnant while using||
1207|146|P|dihydroergotamine. Dihydroergotamine may harm an unborn baby. If||
1207|147|P|you become pregnant, talk to your doctor right away about the||
1207|148|P|risks and benefits of this medication.||
1207|149|P|   This drug may pass into breast milk. Because of the possible||
1207|150|P|risk to the infant, breastfeeding is not recommended while using||
1207|151|P|this drug and for 3 days after the last dose. Consult your doctor||
1207|152|P|before breastfeeding.||
1207|153|B|||
1207|154|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
1207|155|I|   Drug interactions may change how your medications work or||
1207|156|I|increase your risk for serious side effects. This document does||
1207|157|I|not contain all possible drug interactions. Keep a list of all||
1207|158|I|the products you use (including prescription/nonprescription||
1207|159|I|drugs and herbal products) and share it with your doctor and||
1207|160|I|pharmacist. Do not start, stop, or change the dosage of any||
1207|161|I|medicines without your doctor's approval.||
1207|162|I|   If you also take "triptan" migraine drugs (such as||
1207|163|I|sumatriptan, rizatriptan), you will need to separate your||
1207|164|I|"triptan" dose from your dose of this medication to reduce the||
1207|165|I|risk of serious side effects. Ask your doctor how long you should||
1207|166|I|wait between your doses of these drugs.||
1207|167|I|   Some products have ingredients that could raise your heart||
1207|168|I|rate or blood pressure. Tell your pharmacist what products you||
1207|169|I|are using, and ask how to use them safely (especially||
1207|170|I|cough-and-cold products, bronchodilators, stimulants, diet aids,||
1207|171|I|or other migraine medications).||
1207|172|B|||
1207|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1207|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1207|175|O|poison control center right away. US residents can call||
1207|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1207|177|O|Symptoms of overdose may include: severe dizziness/drowsiness,||
1207|178|O|loss of feeling in the fingers/toes, rapid/weak heartbeat, bluish||
1207|179|O|hands/feet, seizures.||
1207|180|B|||
1207|181|N|NOTES:  Do not share this medication with others.||
1207|182|N|   Lab and/or medical tests (such as heart function) may be done||
1207|183|N|while you are using this medication. Keep all medical and lab||
1207|184|N|appointments. Consult your doctor for more details.||
1207|185|N|   Certain foods/beverages or food additives (such as red wine,||
1207|186|N|cheese, chocolate, monosodium glutamate, alcohol) as well as some||
1207|187|N|lifestyle patterns (such as irregular eating/sleeping habits,||
1207|188|N|stress) may bring about a migraine headache. Avoiding these||
1207|189|N|"triggers" may help decrease the frequency of migraine headaches.||
1207|190|N|Consult your doctor for more details.||
1207|191|B|||
1207|192|D|MISSED DOSE:  Not applicable.||
1207|193|B|||
1207|194|R|STORAGE:  Store at room temperature away from heat. Do not||
1207|195|R|refrigerate or freeze. Keep the medication in the original carton||
1207|196|R|to protect from light. Keep all medications away from children||
1207|197|R|and pets.||
1207|198|R|   Do not flush medications down the toilet or pour them into a||
1207|199|R|drain unless instructed to do so. Properly discard this product||
1207|200|R|when it is expired or no longer needed. Consult your pharmacist||
1207|201|R|or local waste disposal company.||
1207|202|B|||
1207|203|A|Information last revised September 2025.||
1207|204|A|Copyright(c) 2025 First Databank, Inc.||
1207|205|B|||
1208|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1208|002|Z|does NOT have all possible information about this product. This||
1208|003|Z|information does not assure that this product is safe, effective,||
1208|004|Z|or appropriate for you. This information is not individual||
1208|005|Z|medical advice and does not substitute for the advice of your||
1208|006|Z|health care professional. Always ask your health care||
1208|007|Z|professional for complete information about this product and your||
1208|008|Z|specific health needs.||
1208|009|B|||
1208|010|T|CIPROFLOXACIN SOLUTION - OTIC||
1208|011|F|(SIP-roe-FLOX-a-sin)||
1208|012|B|||
1208|013|C|COMMON BRAND NAME(S): Cetraxal||
1208|014|B|||
1208|015|U|USES:  Ciprofloxacin is used to treat bacterial ear infections||
1208|016|U|(swimmer's ear or ear canal infections). It works by stopping the||
1208|017|U|growth of bacteria. This medication belongs to a class of drugs||
1208|018|U|called quinolone antibiotics.||
1208|019|U|   This medication treats only bacterial ear infections. It will||
1208|020|U|not work for other types of ear infections. Unnecessary use or||
1208|021|U|overuse of any antibiotic can lead to its decreased||
1208|022|U|effectiveness.||
1208|023|B|||
1208|024|H|HOW TO USE:  Learn all preparation and usage instructions before||
1208|025|H|using this medication. For accuracy and to avoid contamination,||
1208|026|H|have another person give the drops if possible. Hold the||
1208|027|H|container in your hand for a few minutes to warm it. This will||
1208|028|H|minimize dizziness. Wash your hands before opening/using the||
1208|029|H|medication. To avoid contamination, do not touch the dropper tip||
1208|030|H|or let it touch your ear or any other surface.||
1208|031|H|   Use this medication in the infected ear as directed by your||
1208|032|H|doctor, usually twice daily (every 12 hours) for 7 days. Use in||
1208|033|H|the ear only. Do not use in the eyes, inject, or inhale the||
1208|034|H|medication.||
1208|035|H|   Lie on your side or tilt your head with the ear to be treated||
1208|036|H|facing upward. Hold the container directly over the ear, and||
1208|037|H|empty the contents of the single-use container into the ear||
1208|038|H|canal. While placing the solution into the ear of an adult, the||
1208|039|H|earlobe should be gently pulled up and back to allow the drops to||
1208|040|H|flow down into the ear canal. For children, gently pull the||
1208|041|H|earlobe down and back. Keep the head tilted with the treated ear||
1208|042|H|upward for at least 1 minute or insert a soft cotton plug if so||
1208|043|H|directed. Discard any unused solution after each application. Do||
1208|044|H|not reuse.||
1208|045|H|   Repeat the above steps for the other ear if so directed.||
1208|046|H|   Use this medication regularly to get the most benefit from it.||
1208|047|H|To help you remember, use it at the same times each day. Continue||
1208|048|H|to use this medication for the full time prescribed, even if||
1208|049|H|symptoms disappear after a few days. Stopping the medication too||
1208|050|H|early may result in a return of the infection.||
1208|051|H|   Tell your doctor if your condition lasts or gets worse after 7||
1208|052|H|days of treatment.||
1208|053|B|||
1208|054|S|SIDE EFFECTS:  Discomfort, pain, or itching in the ear may occur.||
1208|055|S|If any of these effects last or get worse, notify your doctor or||
1208|056|S|pharmacist promptly.||
1208|057|S|   Remember that this medication has been prescribed because your||
1208|058|S|doctor has judged that the benefit to you is greater than the||
1208|059|S|risk of side effects. Many people using this medication do not||
1208|060|S|have serious side effects.||
1208|061|S|   Use of this medication for prolonged or repeated periods may||
1208|062|S|result in a new bacterial/fungal ear infection. Do not use this||
1208|063|S|medication for longer than prescribed. Contact your doctor if you||
1208|064|S|notice new or worsening symptoms.||
1208|065|S|   A very serious allergic reaction to this drug is rare.||
1208|066|S|However, get medical help right away if you notice any symptoms||
1208|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1208|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1208|069|S|breathing.||
1208|070|S|   This is not a complete list of possible side effects. If you||
1208|071|S|notice other effects not listed above, contact your doctor or||
1208|072|S|pharmacist.||
1208|073|S|   In the US -||
1208|074|S|   Call your doctor for medical advice about side effects. You||
1208|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1208|076|S|www.fda.gov/medwatch.||
1208|077|S|   In Canada - Call your doctor for medical advice about side||
1208|078|S|effects. You may report side effects to Health Canada at||
1208|079|S|1-866-234-2345.||
1208|080|B|||
1208|081|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1208|082|P|pharmacist if you are allergic to it or to other quinolone||
1208|083|P|antibiotics (such as ofloxacin, levofloxacin), or if you have any||
1208|084|P|other allergies. This product may contain inactive ingredients,||
1208|085|P|which can cause allergic reactions or other problems. Talk to||
1208|086|P|your pharmacist for more details.||
1208|087|P|   Before using this medication, tell your doctor or pharmacist||
1208|088|P|your medical history.||
1208|089|P|   During pregnancy, this medication should be used only when||
1208|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
1208|091|P|   It is unknown if ciprofloxacin in this ear drop passes into||
1208|092|P|breast milk. Consult your doctor before breastfeeding.||
1208|093|B|||
1208|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1208|095|I|medications work or increase your risk for serious side effects.||
1208|096|I|This document does not contain all possible drug interactions.||
1208|097|I|Keep a list of all the products you use (including||
1208|098|I|prescription/nonprescription drugs and herbal products) and share||
1208|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
1208|100|I|the dosage of any medicines without your doctor's approval.||
1208|101|B|||
1208|102|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1208|103|O|has overdosed and has serious symptoms such as passing out or||
1208|104|O|trouble breathing, call 911. Otherwise, call a poison control||
1208|105|O|center right away. US residents can call 1-800-222-1222. Canada||
1208|106|O|residents can call 1-844-764-7669.||
1208|107|B|||
1208|108|N|NOTES:  Do not share this medication with others.||
1208|109|N|   This medication has been prescribed for your current condition||
1208|110|N|only. Throw away the unused medication after treatment is||
1208|111|N|completed. Do not use it later for another infection unless your||
1208|112|N|doctor tells you to.||
1208|113|N|   It is important to keep the infected ear(s) clean and dry. Try||
1208|114|N|not to get the infected ear(s) wet when bathing. Avoid swimming||
1208|115|N|unless your doctor tells you otherwise.||
1208|116|B|||
1208|117|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1208|118|D|If it is near the time of the next dose, skip the missed dose.||
1208|119|D|Use your next dose at the regular time. Do not double the dose to||
1208|120|D|catch up.||
1208|121|B|||
1208|122|R|STORAGE:  Store at room temperature. Do not freeze. Keep the||
1208|123|R|medication in the original pouch to protect from light. Keep all||
1208|124|R|medications away from children and pets.||
1208|125|R|   Do not flush medications down the toilet or pour them into a||
1208|126|R|drain unless instructed to do so. Properly discard this product||
1208|127|R|when it is expired or no longer needed. Consult your pharmacist||
1208|128|R|or local waste disposal company.||
1208|129|B|||
1208|130|A|Information last revised October 2024.||
1208|131|A|Copyright(c) 2025 First Databank, Inc.||
1208|132|B|||
1209|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1209|002|Z|does NOT have all possible information about this product. This||
1209|003|Z|information does not assure that this product is safe, effective,||
1209|004|Z|or appropriate for you. This information is not individual||
1209|005|Z|medical advice and does not substitute for the advice of your||
1209|006|Z|health care professional. Always ask your health care||
1209|007|Z|professional for complete information about this product and your||
1209|008|Z|specific health needs.||
1209|009|B|||
1209|010|T|TAPENTADOL - ORAL||
1209|011|F|(ta-PEN-ta-dol)||
1209|012|B|||
1209|013|C|COMMON BRAND NAME(S): Nucynta||
1209|014|B|||
1209|015|W|WARNING:  Tapentadol has a risk for abuse and addiction, which||
1209|016|W|can lead to overdose and death. Tapentadol may also cause severe,||
1209|017|W|possibly fatal, breathing problems. To lower your risk, your||
1209|018|W|doctor should have you take the smallest dose of tapentadol that||
1209|019|W|works, and take it for the shortest possible time. See also How||
1209|020|W|to Use section for more information about addiction.||
1209|021|W|   Ask your doctor or pharmacist if you should have medication||
1209|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1209|023|W|Teach your family or household members about the signs of an||
1209|024|W|opioid overdose and how to treat it.||
1209|025|W|   The risk for severe breathing problems is higher when you||
1209|026|W|start this medication and after a dose increase, or if you take||
1209|027|W|the wrong dose/strength. Taking this medication with alcohol or||
1209|028|W|other drugs that can cause drowsiness or breathing problems may||
1209|029|W|cause very serious side effects, including death. Be sure you||
1209|030|W|know how to take tapentadol and what other drugs you should avoid||
1209|031|W|taking with it. See also Drug Interactions section. Get medical||
1209|032|W|help right away if any of these very serious side effects occur:||
1209|033|W|slow/shallow breathing, unusual lightheadedness, severe||
1209|034|W|drowsiness/dizziness, difficulty waking up.||
1209|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1209|036|W|or abuse. If someone accidentally swallows this drug, get medical||
1209|037|W|help right away.||
1209|038|W|   Before using this medication, women of childbearing age should||
1209|039|W|talk with their doctor(s) about the risks and benefits. Tell your||
1209|040|W|doctor if you are pregnant or if you plan to become pregnant.||
1209|041|W|During pregnancy, this medication should be used only when||
1209|042|W|clearly needed. It may slightly increase the risk of birth||
1209|043|W|defects if used during the first two months of pregnancy. Also,||
1209|044|W|using it for a long time or in high doses near the expected||
1209|045|W|delivery date may harm the unborn baby. To lessen the risk, take||
1209|046|W|the smallest effective dose for the shortest possible time.||
1209|047|W|Babies born to mothers who use this drug for a long time may||
1209|048|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1209|049|W|doctor right away if you notice any symptoms in your newborn baby||
1209|050|W|such as crying that doesn't stop, slow/shallow breathing,||
1209|051|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1209|052|W|difficulty gaining weight.||
1209|053|B|||
1209|054|U|USES:  Tapentadol is used to help relieve moderate to severe||
1209|055|U|short-term pain (such as pain from an injury or after surgery).||
1209|056|U|It belongs to a class of drugs known as opioid analgesics. It||
1209|057|U|works in the brain to change how your body feels and responds to||
1209|058|U|pain.||
1209|059|B|||
1209|060|V|OTHER USES:  This section contains uses of this drug that are not||
1209|061|V|listed in the approved professional labeling for the drug but||
1209|062|V|that may be prescribed by your health care professional. Use this||
1209|063|V|drug for a condition that is listed in this section only if it||
1209|064|V|has been so prescribed by your health care professional.||
1209|065|V|   This medication may also be used to help relieve nerve pain||
1209|066|V|(peripheral neuropathy) in people with diabetes.||
1209|067|B|||
1209|068|H|HOW TO USE:  Read the Medication Guide provided by your||
1209|069|H|pharmacist before you start taking tapentadol and each time you||
1209|070|H|get a refill. If you have any questions, ask your doctor or||
1209|071|H|pharmacist.||
1209|072|H|   Take this medication by mouth as directed by your doctor. You||
1209|073|H|may take this drug with or without food. If you have nausea, it||
1209|074|H|may help to take this drug with food. Ask your doctor or||
1209|075|H|pharmacist about other ways to decrease nausea (such as lying||
1209|076|H|down for 1 to 2 hours with as little head movement as possible).||
1209|077|H|   The dosage is based on your medical condition and response to||
1209|078|H|treatment. Do not increase your dose or use this drug more often||
1209|079|H|or for longer than prescribed. Properly stop the medication when||
1209|080|H|so directed.||
1209|081|H|   Pain medications work best if they are used as the first signs||
1209|082|H|of pain occur. If you wait until the pain has worsened, the||
1209|083|H|medication may not work as well.||
1209|084|H|   Suddenly stopping this medication may cause withdrawal,||
1209|085|H|especially if you have used it for a long time or in high doses.||
1209|086|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1209|087|H|Tell your doctor or pharmacist right away if you have any||
1209|088|H|withdrawal symptoms such as restlessness, mental/mood changes||
1209|089|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1209|090|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1209|091|H|aches, or sudden changes in behavior.||
1209|092|H|   When this medication is used for a long time, it may not work||
1209|093|H|as well. Talk with your doctor if this medication stops working||
1209|094|H|well.||
1209|095|H|   Though it helps many people, this medication may sometimes||
1209|096|H|cause addiction. This risk may be higher if you have a||
1209|097|H|mental/mood disorder or a substance use disorder (such as overuse||
1209|098|H|of or addiction to drugs/alcohol). Take this medication exactly||
1209|099|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1209|100|H|pharmacist for more details.||
1209|101|H|   Tell your doctor if your pain does not get better or if it||
1209|102|H|gets worse, or if you have any new pain.||
1209|103|B|||
1209|104|S|SIDE EFFECTS:  See also Warning section.||
1209|105|S|   Nausea, vomiting, constipation, dizziness, or drowsiness may||
1209|106|S|occur. If any of these effects last or get worse, tell your||
1209|107|S|doctor or pharmacist promptly.||
1209|108|S|   To prevent constipation, eat dietary fiber, drink enough||
1209|109|S|water, and exercise. You may also need to take a laxative. Ask||
1209|110|S|your pharmacist which type of laxative is right for you.||
1209|111|S|   To reduce the risk of dizziness and lightheadedness, get up||
1209|112|S|slowly when rising from a sitting or lying position.||
1209|113|S|   Remember that this medication has been prescribed because your||
1209|114|S|doctor has judged that the benefit to you is greater than the||
1209|115|S|risk of side effects. Many people using this medication do not||
1209|116|S|have serious side effects.||
1209|117|S|   Tell your doctor right away if you have any serious side||
1209|118|S|effects, including: confusion, interrupted breathing during sleep||
1209|119|S|(sleep apnea), stomach/abdominal pain, difficulty urinating,||
1209|120|S|signs of your adrenal glands not working well (such as loss of||
1209|121|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
1209|122|S|   Get medical help right away if you have any serious side||
1209|123|S|effects, including: slow/shallow breathing, fainting, seizures,||
1209|124|S|severe drowsiness/difficulty waking up.||
1209|125|S|   This medication may increase serotonin and rarely cause a very||
1209|126|S|serious condition called serotonin syndrome/toxicity. The risk||
1209|127|S|increases if you are also taking other drugs that increase||
1209|128|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1209|129|S|take (see Drug Interactions section). Get medical help right away||
1209|130|S|if you develop some of the following symptoms: fast heartbeat,||
1209|131|S|hallucinations, loss of coordination, severe dizziness, severe||
1209|132|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1209|133|S|unusual agitation/restlessness.||
1209|134|S|   A very serious allergic reaction to this drug is rare.||
1209|135|S|However, get medical help right away if you notice any symptoms||
1209|136|S|of a serious allergic reaction, including: rash, itching/swelling||
1209|137|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1209|138|S|breathing.||
1209|139|S|   This is not a complete list of possible side effects. If you||
1209|140|S|notice other effects not listed above, contact your doctor or||
1209|141|S|pharmacist.||
1209|142|S|   In the US -||
1209|143|S|   Call your doctor for medical advice about side effects. You||
1209|144|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1209|145|S|www.fda.gov/medwatch.||
1209|146|S|   In Canada - Call your doctor for medical advice about side||
1209|147|S|effects. You may report side effects to Health Canada at||
1209|148|S|1-866-234-2345.||
1209|149|B|||
1209|150|P|PRECAUTIONS:  Before taking tapentadol, tell your doctor or||
1209|151|P|pharmacist if you are allergic to it; or if you have any other||
1209|152|P|allergies. This product may contain inactive ingredients, which||
1209|153|P|can cause allergic reactions or other problems. Talk to your||
1209|154|P|pharmacist for more details.||
1209|155|P|   Before using this medication, tell your doctor or pharmacist||
1209|156|P|your medical history, especially of: brain disorders (such as||
1209|157|P|seizures, head injury, tumor), breathing problems (such as||
1209|158|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1209|159|P|gallbladder disease, kidney disease, liver disease, mental/mood||
1209|160|P|disorders (such as confusion, depression, thoughts of suicide),||
1209|161|P|personal or family history of a substance use disorder (such as||
1209|162|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
1209|163|P|problems (such as blockage, constipation, diarrhea due to||
1209|164|P|infection, paralytic ileus), disease of the pancreas||
1209|165|P|(pancreatitis), difficulty urinating (such as due to enlarged||
1209|166|P|prostate).||
1209|167|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1209|168|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1209|169|P|machinery, or do anything that needs alertness until you can do||
1209|170|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1209|171|P|are using marijuana (cannabis).||
1209|172|P|   Before having surgery, tell your doctor or dentist about all||
1209|173|P|the products you use (including prescription drugs,||
1209|174|P|nonprescription drugs, and herbal products).||
1209|175|P|   Older adults may be more sensitive to the side effects of this||
1209|176|P|drug, especially slow/shallow breathing, confusion, constipation,||
1209|177|P|dizziness, and drowsiness.||
1209|178|P|   During pregnancy, this medication should be used only when||
1209|179|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1209|180|P|benefits with your doctor. (See also Warning section.)||
1209|181|P|   It is unknown if this medication passes into breast milk. It||
1209|182|P|may have undesirable effects on a nursing infant. Tell the doctor||
1209|183|P|right away if your baby develops unusual sleepiness, difficulty||
1209|184|P|feeding, or trouble breathing. Consult your doctor before||
1209|185|P|breastfeeding.||
1209|186|B|||
1209|187|I|DRUG INTERACTIONS:  See also Warning section.||
1209|188|I|   Drug interactions may change how your medications work or||
1209|189|I|increase your risk for serious side effects. This document does||
1209|190|I|not contain all possible drug interactions. Keep a list of all||
1209|191|I|the products you use (including prescription/nonprescription||
1209|192|I|drugs and herbal products) and share it with your doctor and||
1209|193|I|pharmacist. Do not start, stop, or change the dosage of any||
1209|194|I|medicines without your doctor's approval.||
1209|195|I|   Some products that may interact with this drug include:||
1209|196|I|certain pain medications (mixed opioid agonist-antagonists such||
1209|197|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1209|198|I|samidorphan.||
1209|199|I|   Taking MAO inhibitors with this medication may cause a serious||
1209|200|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1209|201|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1209|202|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1209|203|I|selegiline, tranylcypromine) during treatment with this||
1209|204|I|medication. Most MAO inhibitors should also not be taken for two||
1209|205|I|weeks before treatment with this medication. Ask your doctor when||
1209|206|I|to start or stop taking this medication.||
1209|207|I|   The risk of serotonin syndrome/toxicity increases if you are||
1209|208|I|also taking other drugs that increase serotonin. Examples include||
1209|209|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1209|210|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1209|211|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1209|212|I|serotonin syndrome/toxicity may be more likely when you start or||
1209|213|I|increase the dose of these drugs.||
1209|214|I|   The risk of serious side effects (such as slow/shallow||
1209|215|I|breathing, severe drowsiness/dizziness) may be increased if this||
1209|216|I|medication is taken with other products that may also cause||
1209|217|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1209|218|I|if you are taking other products such as other opioid pain or||
1209|219|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1209|220|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1209|221|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1209|222|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1209|223|I|cetirizine, diphenhydramine).||
1209|224|I|   Check the labels on all your medicines (such as allergy or||
1209|225|I|cough-and-cold products) because they may contain ingredients||
1209|226|I|that cause drowsiness. Ask your pharmacist about using those||
1209|227|I|products safely.||
1209|228|I|   This medication may interfere with certain lab tests (such as||
1209|229|I|amylase/lipase levels), possibly causing false test results. Make||
1209|230|I|sure lab personnel and all your doctors know you use this drug.||
1209|231|B|||
1209|232|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1209|233|O|as passing out or trouble breathing, give them naloxone or||
1209|234|O|nalmefene if available, then call 911. If the person is awake and||
1209|235|O|has no symptoms, call a poison control center right away. US||
1209|236|O|residents can call 1-800-222-1222. Canada residents can call||
1209|237|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1209|238|O|breathing, slow heartbeat, seizures, coma.||
1209|239|B|||
1209|240|N|NOTES:  Do not share this medication with others. Sharing it is||
1209|241|N|against the law.||
1209|242|N|   This medication has been prescribed for your current condition||
1209|243|N|only. Do not use it later for another condition unless your||
1209|244|N|doctor directs you to do so. A different medication may be||
1209|245|N|necessary in that case.||
1209|246|B|||
1209|247|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1209|248|D|remember. If it is near the time of the next dose, skip the||
1209|249|D|missed dose. Take your next dose at the regular time. Do not||
1209|250|D|double the dose to catch up.||
1209|251|B|||
1209|252|R|STORAGE:  Store at room temperature away from light and moisture.||
1209|253|R|Do not store in the bathroom. Keep all medications away from||
1209|254|R|children and pets.||
1209|255|R|   Do not flush medications down the toilet or pour them into a||
1209|256|R|drain unless instructed to do so. Properly discard this product||
1209|257|R|when it is expired or no longer needed. For more details, read||
1209|258|R|the Medication Guide, or consult your pharmacist or local waste||
1209|259|R|disposal company.||
1209|260|B|||
1209|261|A|Information last revised August 2025.||
1209|262|A|Copyright(c) 2025 First Databank, Inc.||
1209|263|B|||
1210|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1210|002|Z|does NOT have all possible information about this product. This||
1210|003|Z|information does not assure that this product is safe, effective,||
1210|004|Z|or appropriate for you. This information is not individual||
1210|005|Z|medical advice and does not substitute for the advice of your||
1210|006|Z|health care professional. Always ask your health care||
1210|007|Z|professional for complete information about this product and your||
1210|008|Z|specific health needs.||
1210|009|B|||
1210|010|T|FLUPENTIXOL DECANOATE - INJECTION||
1210|011|F|(flew-pen-TICK-sole deck-ah-NO-ate)||
1210|012|B|||
1210|013|W|WARNING:  This medication may rarely cause a serious, possibly||
1210|014|W|fatal condition called neuroleptic malignant syndrome (NMS). Get||
1210|015|W|medical help right away if you have any of the following||
1210|016|W|symptoms: fever, muscle stiffness/pain/tenderness/weakness,||
1210|017|W|severe tiredness, severe confusion, sweating, fast/irregular||
1210|018|W|heartbeat, dark urine, signs of kidney problems (such as change||
1210|019|W|in the amount of urine).||
1210|020|W|   There may be a slightly increased risk of serious, possibly||
1210|021|W|fatal side effects (such as heart failure, fast/irregular||
1210|022|W|heartbeat, pneumonia) when this medication is used by older||
1210|023|W|adults with dementia. This medication is not approved for the||
1210|024|W|treatment of dementia-related behavior problems. Discuss the||
1210|025|W|risks and benefits of this medication, as well as other effective||
1210|026|W|and possibly safer treatments for dementia-related behavior||
1210|027|W|problems, with the doctor.||
1210|028|B|||
1210|029|U|USES:  This medication is used to treat certain mental/mood||
1210|030|U|disorders (such as schizophrenia, psychosis). Flupentixol||
1210|031|U|decanoate is a long-acting form of flupentixol. It may be used by||
1210|032|U|people who have trouble remembering to take medication every day.||
1210|033|U|Flupentixol belongs to a class of drugs known as antipsychotics.||
1210|034|U|It works by helping to restore the balance of certain natural||
1210|035|U|substances in the brain.||
1210|036|B|||
1210|037|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1210|038|H|from your pharmacist before you start using flupentixol and each||
1210|039|H|time you get a refill. If you have any questions, ask your doctor||
1210|040|H|or pharmacist.||
1210|041|H|   This medication is given by injection into a muscle by a||
1210|042|H|health care professional as directed by your doctor, usually||
1210|043|H|every 2 to 3 weeks. Do not inject into a vein.||
1210|044|H|   The dosage is based on your medical condition and response to||
1210|045|H|treatment. Your doctor will adjust your dose to find the best||
1210|046|H|dose for you. Your first injection may be a lower dose than your||
1210|047|H|routine dose. A second dose may be given 4 to 10 days later. Your||
1210|048|H|doctor may direct you to take the oral form of this medication by||
1210|049|H|mouth until the injected form starts to work.||
1210|050|H|   Use this medication regularly to get the most benefit from it.||
1210|051|H|To help you remember, mark your calendar with a reminder.||
1210|052|H|   Do not stop using this medication without consulting your||
1210|053|H|doctor. Your condition may become worse if the drug is suddenly||
1210|054|H|stopped. Your dose may need to be gradually decreased.||
1210|055|H|   Tell your doctor if your symptoms do not get better or if they||
1210|056|H|get worse.||
1210|057|B|||
1210|058|S|SIDE EFFECTS:  See also Warning section.||
1210|059|S|   Injection site reactions (such as pain, swelling), drowsiness,||
1210|060|S|dizziness, lightheadedness, restlessness, or trouble sleeping may||
1210|061|S|occur. If any of these effects last or get worse, notify your||
1210|062|S|doctor or pharmacist promptly.||
1210|063|S|   Dizziness and lightheadedness can increase the risk of||
1210|064|S|falling. Get up slowly when rising from a sitting or lying||
1210|065|S|position.||
1210|066|S|   Tell your doctor right away if any of these side effects||
1210|067|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
1210|068|S|mask-like expression of the face, drooling/trouble swallowing, or||
1210|069|S|shuffling walk. Your doctor may prescribe another medication to||
1210|070|S|decrease these side effects.||
1210|071|S|   Remember that this medication has been prescribed because your||
1210|072|S|doctor has judged that the benefit to you is greater than the||
1210|073|S|risk of side effects. Many people using this medication do not||
1210|074|S|have serious side effects.||
1210|075|S|   Tell your doctor right away if you have any serious side||
1210|076|S|effects, including: unusual mental/mood changes (such as||
1210|077|S|depression, mania, worsening of psychosis), difficult urination,||
1210|078|S|vision problems, signs of infection (such as sore throat that||
1210|079|S|doesn't go away, fever, chills), easy bruising/bleeding,||
1210|080|S|stomach/abdominal pain, yellowing eyes/skin, severe constipation.||
1210|081|S|   Rarely, this medication may increase your level of a certain||
1210|082|S|hormone (prolactin). For females, this effect may result in||
1210|083|S|unwanted breast milk, missing/stopped menstrual periods, or||
1210|084|S|difficulty becoming pregnant. For males, it may result in||
1210|085|S|decreased sexual ability, inability to produce sperm, or enlarged||
1210|086|S|breasts. If you develop any of these symptoms, tell your doctor||
1210|087|S|right away.||
1210|088|S|   Rarely, males may have a painful or prolonged erection lasting||
1210|089|S|4 or more hours. If this occurs, stop using this drug and get||
1210|090|S|medical help right away, or permanent problems could occur.||
1210|091|S|   This medication may rarely cause a condition known as tardive||
1210|092|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1210|093|S|your doctor right away if you develop any unusual/uncontrolled||
1210|094|S|movements (especially of the face, mouth, tongue, arms, or legs).||
1210|095|S|   Get medical help right away if you have any very serious side||
1210|096|S|effects, including: chest pain, severe dizziness, fainting,||
1210|097|S|seizures.||
1210|098|S|   A very serious allergic reaction to this drug is rare.||
1210|099|S|However, get medical help right away if you notice any symptoms||
1210|100|S|of a serious allergic reaction, including: rash, itching/swelling||
1210|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1210|102|S|breathing.||
1210|103|S|   This is not a complete list of possible side effects. If you||
1210|104|S|notice other effects not listed above, contact your doctor or||
1210|105|S|pharmacist.||
1210|106|S|   In the US -||
1210|107|S|   Call your doctor for medical advice about side effects. You||
1210|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1210|109|S|www.fda.gov/medwatch.||
1210|110|S|   In Canada - Call your doctor for medical advice about side||
1210|111|S|effects. You may report side effects to Health Canada at||
1210|112|S|1-866-234-2345.||
1210|113|B|||
1210|114|P|PRECAUTIONS:  Before using flupentixol, tell your doctor or||
1210|115|P|pharmacist if you are allergic to it; or to other thioxanthenes||
1210|116|P|(such as thiothixene, zuclopenthixol); or if you have any other||
1210|117|P|allergies. This product may contain inactive ingredients (such as||
1210|118|P|medium chain triglycerides), which can cause allergic reactions||
1210|119|P|or other problems. Talk to your pharmacist for more details.||
1210|120|P|   Before using this medication, tell your doctor or pharmacist||
1210|121|P|your medical history, especially of: blood problems (such as low||
1210|122|P|white blood cell count, anemia), high or low blood pressure,||
1210|123|P|brain problems (injury/tumor, confusion with difficulty staying||
1210|124|P|awake), blood flow problems (such as chest pain, heart attack,||
1210|125|P|stroke), breast cancer, glaucoma, slowed gut movement (such as||
1210|126|P|chronic constipation, ileus, blockage), kidney problems, liver||
1210|127|P|problems, Parkinson's disease, a certain adrenal gland tumor||
1210|128|P|(pheochromocytoma), seizures, difficulty urinating (such as due||
1210|129|P|to enlarged prostate), drug/alcohol dependency.||
1210|130|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1210|131|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1210|132|P|machinery, or do anything that needs alertness until you can do||
1210|133|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1210|134|P|are using marijuana (cannabis).||
1210|135|P|   Before having surgery, tell your doctor or dentist about all||
1210|136|P|the products you use (including prescription drugs,||
1210|137|P|nonprescription drugs, and herbal products).||
1210|138|P|   This medication may make you more sensitive to the sun. Limit||
1210|139|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1210|140|P|sunscreen and wear protective clothing when outdoors. Tell your||
1210|141|P|doctor right away if you get sunburned or have skin||
1210|142|P|blisters/redness.||
1210|143|P|   This medication may make you sweat less, making you more||
1210|144|P|likely to get heat stroke. Avoid doing things that may cause you||
1210|145|P|to overheat, such as hard work or exercise in hot weather, or||
1210|146|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1210|147|P|and dress lightly. If you overheat, quickly look for a place to||
1210|148|P|cool down and rest. Get medical help right away if you have a||
1210|149|P|fever that does not go away, mental/mood changes, headache, or||
1210|150|P|dizziness.||
1210|151|P|   Avoid contact with certain types of insecticides||
1210|152|P|(organophosphates).||
1210|153|P|   Flupentixol may cause a condition that affects the heart||
1210|154|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1210|155|P|serious (rarely fatal) fast/irregular heartbeat and other||
1210|156|P|symptoms (such as severe dizziness, fainting) that need medical||
1210|157|P|attention right away.||
1210|158|P|   The risk of QT prolongation may be increased if you have||
1210|159|P|certain medical conditions or are taking other drugs that may||
1210|160|P|cause QT prolongation. Before using flupentixol, tell your doctor||
1210|161|P|or pharmacist of all the drugs you take and if you have any of||
1210|162|P|the following conditions: certain heart problems (heart failure,||
1210|163|P|slow heartbeat, QT prolongation in the EKG), family history of||
1210|164|P|certain heart problems (QT prolongation in the EKG, sudden||
1210|165|P|cardiac death).||
1210|166|P|   Low levels of potassium or magnesium in the blood may also||
1210|167|P|increase your risk of QT prolongation. This risk may increase if||
1210|168|P|you use certain drugs (such as diuretics/"water pills") or if you||
1210|169|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1210|170|P|Talk to your doctor about using flupentixol safely.||
1210|171|P|   Older adults may be more sensitive to the side effects of this||
1210|172|P|drug, especially drowsiness, dizziness, lightheadedness, muscle||
1210|173|P|spasms/stiffness/twitching, uncontrolled movements (tardive||
1210|174|P|dyskinesia), and QT prolongation (see above). Drowsiness,||
1210|175|P|dizziness, and lightheadedness can increase the risk of falling.||
1210|176|P|   During pregnancy, this medication should be used only when||
1210|177|P|clearly needed. Babies born to mothers who have used this drug||
1210|178|P|during the last 3 months of pregnancy may rarely develop symptoms||
1210|179|P|including muscle stiffness or shakiness, drowsiness,||
1210|180|P|feeding/breathing difficulties, or constant crying. If you notice||
1210|181|P|any of these symptoms in your newborn especially during their||
1210|182|P|first month, tell the doctor right away.||
1210|183|P|   Since untreated mental/mood problems (such as schizophrenia,||
1210|184|P|psychosis) can be a serious condition, do not stop taking this||
1210|185|P|medication unless directed by your doctor. If you are planning||
1210|186|P|pregnancy, become pregnant, or think you may be pregnant,||
1210|187|P|immediately discuss with your doctor the benefits and risks of||
1210|188|P|using this medication during pregnancy.||
1210|189|P|   Flupentixol passes into breast milk and may harm a nursing||
1210|190|P|infant. Breastfeeding is not recommended while using this||
1210|191|P|medication. Consult your doctor before breastfeeding.||
1210|192|B|||
1210|193|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1210|194|I|medications work or increase your risk for serious side effects.||
1210|195|I|This document does not contain all possible drug interactions.||
1210|196|I|Keep a list of all the products you use (including||
1210|197|I|prescription/nonprescription drugs and herbal products) and share||
1210|198|I|it with your doctor and pharmacist. Do not start, stop, or change||
1210|199|I|the dosage of any medicines without your doctor's approval.||
1210|200|I|   Some products that may interact with this drug include:||
1210|201|I|certain drugs for high blood pressure (methyldopa, guanethidine,||
1210|202|I|guanadrel, hydralazine), lithium.||
1210|203|I|   Many drugs besides flupentixol may affect the heart rhythm (QT||
1210|204|I|prolongation), including amiodarone, dofetilide, pimozide,||
1210|205|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
1210|206|I|erythromycin), among others.||
1210|207|I|   Tell your doctor or pharmacist if you are taking other||
1210|208|I|products that cause drowsiness such as opioid pain or cough||
1210|209|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1210|210|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1210|211|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1210|212|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1210|213|I|diphenhydramine).||
1210|214|I|   Check the labels on all your medicines (such as allergy or||
1210|215|I|cough-and-cold products) because they may contain ingredients||
1210|216|I|that cause drowsiness. Ask your pharmacist about using those||
1210|217|I|products safely.||
1210|218|B|||
1210|219|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1210|220|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1210|221|O|poison control center right away. US residents can call||
1210|222|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1210|223|O|Symptoms of overdose may include: loss of consciousness,||
1210|224|O|seizures, fast/irregular heartbeat, slow/shallow breathing.||
1210|225|B|||
1210|226|N|NOTES:  Lab and/or medical tests (such as liver function,||
1210|227|N|complete blood counts) may be done while you are using this||
1210|228|N|medication. Keep all medical and lab appointments. Consult your||
1210|229|N|doctor for more details.||
1210|230|B|||
1210|231|D|MISSED DOSE:  It is important to get each dose of this medication||
1210|232|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1210|233|D|right away for a new dosing schedule.||
1210|234|B|||
1210|235|R|STORAGE:  Not applicable. This medication is given in a clinic||
1210|236|R|and will not be stored at home.||
1210|237|B|||
1210|238|A|Information last revised April 2025.||
1210|239|A|Copyright(c) 2025 First Databank, Inc.||
1210|240|B|||
1212|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1212|002|Z|does NOT have all possible information about this product. This||
1212|003|Z|information does not assure that this product is safe, effective,||
1212|004|Z|or appropriate for you. This information is not individual||
1212|005|Z|medical advice and does not substitute for the advice of your||
1212|006|Z|health care professional. Always ask your health care||
1212|007|Z|professional for complete information about this product and your||
1212|008|Z|specific health needs.||
1212|009|B|||
1212|010|T|ZOLPIDEM - SUBLINGUAL||
1212|011|F|(ZOHL-pee-dem)||
1212|012|B|||
1212|013|C|COMMON BRAND NAME(S): Edluar||
1212|014|B|||
1212|015|W|WARNING:  Rarely, after taking this drug, people have gotten out||
1212|016|W|of bed and driven vehicles while not fully awake||
1212|017|W|("sleep-driving"). People have also sleepwalked, prepared/eaten||
1212|018|W|food, made phone calls, or had sex while not fully awake. Often,||
1212|019|W|these people do not remember these events. This problem can be||
1212|020|W|dangerous (possibly fatal) to you or to others. If you find out||
1212|021|W|that you have done any of these activities after taking this||
1212|022|W|medication, tell your doctor right away. You should not take this||
1212|023|W|medication or similar medications (such as eszopiclone, zaleplon)||
1212|024|W|if you have this reaction to the medication.||
1212|025|B|||
1212|026|U|USES:  Zolpidem is used for a short time to treat a certain sleep||
1212|027|U|problem (insomnia). If you have trouble falling asleep, it helps||
1212|028|U|you fall asleep faster, so you can get a better night's rest.||
1212|029|U|Zolpidem belongs to a class of drugs called sedative-hypnotics.||
1212|030|U|It acts on your brain to produce a calming effect.||
1212|031|B|||
1212|032|H|HOW TO USE:  Read the Medication Guide provided by your||
1212|033|H|pharmacist before you start taking zolpidem and each time you get||
1212|034|H|a refill. If you have any questions, ask your doctor or||
1212|035|H|pharmacist.||
1212|036|H|   Take this medication by mouth on an empty stomach as directed||
1212|037|H|by your doctor, usually just before you get into bed. Do not take||
1212|038|H|it with or after a meal because it will not work as quickly.||
1212|039|H|   Place the tablet under your tongue and let it dissolve. Do not||
1212|040|H|swallow the tablet or take it with water.||
1212|041|H|   Although unlikely, this drug can rarely cause temporary||
1212|042|H|short-term memory loss. To lessen the chance of this, do not take||
1212|043|H|a dose of this drug unless you have time for a full night's sleep||
1212|044|H|of at least 7 to 8 hours. If you have to wake up before that, you||
1212|045|H|may have some memory loss and may have trouble safely doing||
1212|046|H|anything that needs alertness, such as driving or operating||
1212|047|H|machinery. (See also Precautions section.)||
1212|048|H|   The dosage is based on your gender, age, medical condition,||
1212|049|H|other medications you may be taking, and response to treatment.||
1212|050|H|Do not increase your dose, take it more often, or use it for||
1212|051|H|longer than prescribed. Do not take more than 10 milligrams a||
1212|052|H|day. Women are usually prescribed a lower dose because the drug||
1212|053|H|is removed from their bodies more slowly than in men. Older||
1212|054|H|adults are usually prescribed a lower dose to decrease the risk||
1212|055|H|of side effects.||
1212|056|H|   If you suddenly stop using this medication, you may have||
1212|057|H|withdrawal symptoms (such as nausea, vomiting, flushing, stomach||
1212|058|H|cramps, nervousness, shakiness). To help prevent withdrawal, your||
1212|059|H|doctor may lower your dose slowly. Withdrawal is more likely if||
1212|060|H|you have used zolpidem for a long time or in high doses. Tell||
1212|061|H|your doctor or pharmacist right away if you have withdrawal.||
1212|062|H|   When this medication is used for a long time, it may not work||
1212|063|H|as well. Talk with your doctor if this medication stops working||
1212|064|H|well.||
1212|065|H|   Though it helps many people, this medication may sometimes||
1212|066|H|cause addiction. This risk may be higher if you have a substance||
1212|067|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1212|068|H|Take this medication exactly as prescribed to lower the risk of||
1212|069|H|addiction. Ask your doctor or pharmacist for more details.||
1212|070|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
1212|071|H|or if it gets worse.||
1212|072|H|   You may have trouble sleeping the first few nights after you||
1212|073|H|stop taking this medication. This is called rebound insomnia and||
1212|074|H|is normal. It will usually go away after 1 or 2 nights. If this||
1212|075|H|effect continues, contact your doctor.||
1212|076|B|||
1212|077|S|SIDE EFFECTS:  See also Warning section.||
1212|078|S|   Dizziness or difficulty with coordination may occur. If either||
1212|079|S|of these effects lasts or gets worse, tell your doctor or||
1212|080|S|pharmacist promptly. To reduce the risk of dizziness or falling,||
1212|081|S|get up slowly when rising from a sitting or lying position.||
1212|082|S|   This medication may make you sleepy during the day. Tell your||
1212|083|S|doctor if you have daytime drowsiness. Your dose may need to be||
1212|084|S|adjusted.||
1212|085|S|   Remember that this medication has been prescribed because your||
1212|086|S|doctor has judged that the benefit to you is greater than the||
1212|087|S|risk of side effects. Many people using this medication do not||
1212|088|S|have serious side effects.||
1212|089|S|   Tell your doctor right away if you have any serious side||
1212|090|S|effects, including: memory loss, mental/mood/behavior changes||
1212|091|S|(such as new/worsening depression, abnormal thoughts, thoughts of||
1212|092|S|suicide, hallucinations, confusion, agitation, aggressive||
1212|093|S|behavior, anxiety).||
1212|094|S|   A very serious allergic reaction to this drug is rare.||
1212|095|S|However, get medical help right away if you notice any symptoms||
1212|096|S|of a serious allergic reaction, including: rash, itching/swelling||
1212|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1212|098|S|breathing.||
1212|099|S|   This is not a complete list of possible side effects. If you||
1212|100|S|notice other effects not listed above, contact your doctor or||
1212|101|S|pharmacist.||
1212|102|S|   In the US -||
1212|103|S|   Call your doctor for medical advice about side effects. You||
1212|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1212|105|S|www.fda.gov/medwatch.||
1212|106|S|   In Canada - Call your doctor for medical advice about side||
1212|107|S|effects. You may report side effects to Health Canada at||
1212|108|S|1-866-234-2345.||
1212|109|B|||
1212|110|P|PRECAUTIONS:  See also Warning section.||
1212|111|P|   Before taking zolpidem, tell your doctor or pharmacist if you||
1212|112|P|are allergic to it; or if you have any other allergies. This||
1212|113|P|product may contain inactive ingredients, which can cause||
1212|114|P|allergic reactions or other problems. Talk to your pharmacist for||
1212|115|P|more details.||
1212|116|P|   Before using this medication, tell your doctor or pharmacist||
1212|117|P|your medical history, especially of: kidney disease, liver||
1212|118|P|disease, lung/breathing problems (such as chronic obstructive||
1212|119|P|pulmonary disease-COPD, sleep apnea), mental/mood problems (such||
1212|120|P|as depression, thoughts of suicide), personal or family history||
1212|121|P|of a substance use disorder (such as overuse of or addiction to||
1212|122|P|drugs/alcohol), personal or family history of sleepwalking, a||
1212|123|P|certain muscle disease (myasthenia gravis).||
1212|124|P|   The effects of this drug can last even after you wake up the||
1212|125|P|next day. If you did not get 7 to 8 hours of sleep or took other||
1212|126|P|medications that made you sleepy or are more sensitive to this||
1212|127|P|drug, you may feel alert but not think clearly enough to drive.||
1212|128|P|You may also experience dizziness or blurred/double vision.||
1212|129|P|Alcohol or marijuana (cannabis) can make you more dizzy. Wait at||
1212|130|P|least 8 hours after taking this drug before driving, and do not||
1212|131|P|drive, use machinery, or do anything that needs alertness until||
1212|132|P|you can do it safely. This medication may also increase the risk||
1212|133|P|of falls. Avoid alcoholic beverages. Talk to your doctor if you||
1212|134|P|are using marijuana (cannabis).||
1212|135|P|   Before having surgery, tell your doctor or dentist about all||
1212|136|P|the products you use (including prescription drugs,||
1212|137|P|nonprescription drugs, and herbal products).||
1212|138|P|   Children may be more sensitive to the side effects of this||
1212|139|P|drug, especially dizziness and hallucinations.||
1212|140|P|   Older adults may be more sensitive to the side effects of this||
1212|141|P|drug, especially dizziness, confusion, unsteadiness, and||
1212|142|P|excessive drowsiness. These side effects can increase the risk of||
1212|143|P|falling.||
1212|144|P|   During pregnancy, this medication should be used only when||
1212|145|P|clearly needed. Babies born to mothers who have used this drug||
1212|146|P|late in the last 3 months of pregnancy may develop unusual||
1212|147|P|sleepiness, trouble breathing, unusual limpness, or withdrawal||
1212|148|P|symptoms. Get medical help right away if you notice any unusual||
1212|149|P|symptoms in your newborn. Discuss the risks and benefits with||
1212|150|P|your doctor.||
1212|151|P|   A small amount of this medication passes into breast milk and||
1212|152|P|may have undesirable effects on a nursing infant (such as unusual||
1212|153|P|sleepiness, trouble breathing, or unusual limpness). Get medical||
1212|154|P|help right away if you notice any unusual symptoms in your baby.||
1212|155|P|Ask your doctor if you should pump and discard your breast milk||
1212|156|P|during treatment and for 23 hours after a dose of this medication||
1212|157|P|to lessen the risk of these effects in your baby. Consult your||
1212|158|P|doctor before breastfeeding.||
1212|159|B|||
1212|160|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1212|161|I|medications work or increase your risk for serious side effects.||
1212|162|I|This document does not contain all possible drug interactions.||
1212|163|I|Keep a list of all the products you use (including||
1212|164|I|prescription/nonprescription drugs and herbal products) and share||
1212|165|I|it with your doctor and pharmacist. Do not start, stop, or change||
1212|166|I|the dosage of any medicines without your doctor's approval.||
1212|167|I|   A product that may interact with this drug is: sodium oxybate.||
1212|168|I|   Other medications can affect the removal of zolpidem from your||
1212|169|I|body, which may affect how zolpidem works. Examples include azole||
1212|170|I|antifungals (such as ketoconazole), rifampin, St. John's Wort,||
1212|171|I|among others.||
1212|172|I|   The risk of serious side effects (such as slow/shallow||
1212|173|I|breathing, severe drowsiness/dizziness) may be increased if this||
1212|174|I|medication is taken with other products that may also cause||
1212|175|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1212|176|I|if you are taking other products such as opioid pain or cough||
1212|177|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1212|178|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
1212|179|I|lorazepam, zopiclone), muscle relaxants (such as carisoprodol,||
1212|180|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1212|181|I|diphenhydramine).||
1212|182|I|   Check the labels on all your medicines (such as allergy or||
1212|183|I|cough-and-cold products) because they may contain ingredients||
1212|184|I|that cause drowsiness. Ask your pharmacist about using those||
1212|185|I|products safely.||
1212|186|B|||
1212|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1212|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1212|189|O|poison control center right away. US residents can call||
1212|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1212|191|O|Symptoms of overdose may include slowed breathing or a deep sleep||
1212|192|O|from which you cannot be awakened.||
1212|193|B|||
1212|194|N|NOTES:  Do not share this medication with others. Sharing it is||
1212|195|N|against the law.||
1212|196|N|   As you get older, your sleep pattern may naturally change and||
1212|197|N|your sleep may be interrupted several times during the night.||
1212|198|N|Consult your doctor or pharmacist for ways to improve your sleep||
1212|199|N|without medication, such as avoiding caffeine and alcohol close||
1212|200|N|to bedtime, avoiding daytime naps, and going to bed at the same||
1212|201|N|time each night.||
1212|202|B|||
1212|203|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
1212|204|D|time to sleep for 7 to 8 hours afterward. (See also How to Use||
1212|205|D|section.)||
1212|206|B|||
1212|207|R|STORAGE:  Store at room temperature away from light and moisture.||
1212|208|R|Do not store in the bathroom. Keep all medications away from||
1212|209|R|children and pets.||
1212|210|R|   Do not flush medications down the toilet or pour them into a||
1212|211|R|drain unless instructed to do so. Properly discard this product||
1212|212|R|when it is expired or no longer needed. Consult your pharmacist||
1212|213|R|or local waste disposal company.||
1212|214|B|||
1212|215|A|Information last revised May 2024.||
1212|216|A|Copyright(c) 2025 First Databank, Inc.||
1212|217|B|||
1213|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1213|002|Z|does NOT have all possible information about this product. This||
1213|003|Z|information does not assure that this product is safe, effective,||
1213|004|Z|or appropriate for you. This information is not individual||
1213|005|Z|medical advice and does not substitute for the advice of your||
1213|006|Z|health care professional. Always ask your health care||
1213|007|Z|professional for complete information about this product and your||
1213|008|Z|specific health needs.||
1213|009|B|||
1213|010|T|IBUPROFEN - INJECTION||
1213|011|F|(EYE-bue-PROE-fen)||
1213|012|B|||
1213|013|C|COMMON BRAND NAME(S): Caldolor||
1213|014|B|||
1213|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1213|016|W|ibuprofen) may rarely increase the risk for a heart attack or||
1213|017|W|stroke. This effect can happen at any time while using this drug||
1213|018|W|but is more likely if you use it for a long time. The risk may be||
1213|019|W|greater in older adults or if you have heart disease or increased||
1213|020|W|risk for heart disease (for example, due to smoking, family||
1213|021|W|history of heart disease, or conditions such as high blood||
1213|022|W|pressure or diabetes). Do not use this drug right before or after||
1213|023|W|heart bypass surgery (CABG).||
1213|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
1213|025|W|bleeding from the stomach or intestines. This effect can occur||
1213|026|W|without warning symptoms at any time while taking this drug.||
1213|027|W|Older adults may be at higher risk for this effect.||
1213|028|W|   Stop using ibuprofen and get medical help right away if you||
1213|029|W|notice any of these rare but serious side effects:||
1213|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
1213|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1213|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
1213|033|W|side of the body, trouble speaking, sudden vision changes.||
1213|034|B|||
1213|035|U|USES:  Ibuprofen is used to help relieve mild to moderate pain.||
1213|036|U|When used with an opioid (such as morphine), it may be used to||
1213|037|U|relieve moderate to severe pain. It is also used to reduce fever.||
1213|038|U|   Ibuprofen is known as a nonsteroidal anti-inflammatory drug||
1213|039|U|(NSAID). It works by blocking your body's production of certain||
1213|040|U|natural substances that cause inflammation. This effect helps to||
1213|041|U|decrease swelling, pain, or fever.||
1213|042|B|||
1213|043|H|HOW TO USE:  Read the Medication Guide provided by your||
1213|044|H|pharmacist before you start using ibuprofen and each time you get||
1213|045|H|a refill. If you have any questions, ask your doctor or||
1213|046|H|pharmacist.||
1213|047|H|   If you are using this medication at home, read and learn all||
1213|048|H|preparation and usage instructions from the manufacturer or from||
1213|049|H|your health care professional. If you have any questions about||
1213|050|H|using this medication properly, ask your doctor or pharmacist.||
1213|051|H|   Before using, check this product for particles or||
1213|052|H|discoloration. If either is present, do not use the liquid.||
1213|053|H|   This medication is given by injection into a vein as directed||
1213|054|H|by your doctor, usually over at least 30 minutes (adults) or over||
1213|055|H|at least 10 minutes (children). When used to relieve pain, it is||
1213|056|H|usually given every 6 hours as needed. When used to reduce fever,||
1213|057|H|this drug may be given every 4 to 6 hours as needed. Infants 3 to||
1213|058|H|6 months of age should be given this medication as a single dose.||
1213|059|H|Follow your doctor's directions carefully.||
1213|060|H|   Learn how to store and discard needles and medical supplies||
1213|061|H|safely. Consult your pharmacist for more details.||
1213|062|H|   Drink plenty of fluids while using this medication unless your||
1213|063|H|doctor tells you otherwise.||
1213|064|H|   The dosage is based on your medical condition, age, and||
1213|065|H|response to treatment. Children's dosage is also based on weight.||
1213|066|H|To reduce your risk of stomach bleeding and other side effects,||
1213|067|H|use this medication at the lowest effective dose for the shortest||
1213|068|H|possible time. Do not increase your dose or use this drug more||
1213|069|H|often or for longer than prescribed.||
1213|070|H|   If you are using this drug "as needed" (not on a regular||
1213|071|H|schedule), remember that pain medications work best if they are||
1213|072|H|used as the first signs of pain occur. If you wait until the pain||
1213|073|H|has worsened, the medicine may not work as well.||
1213|074|H|   Tell your doctor if your pain or fever lasts or gets worse.||
1213|075|B|||
1213|076|S|SIDE EFFECTS:  See also Warning section.||
1213|077|S|   Nausea, dizziness, gas, headache, and upset stomach may occur.||
1213|078|S|If any of these effects last or get worse, tell your doctor or||
1213|079|S|pharmacist promptly.||
1213|080|S|   Remember that this medication has been prescribed because your||
1213|081|S|doctor has judged that the benefit to you is greater than the||
1213|082|S|risk of side effects. Many people using this medication do not||
1213|083|S|have serious side effects.||
1213|084|S|   This medication may raise your blood pressure. Check your||
1213|085|S|blood pressure regularly and tell your doctor if the results are||
1213|086|S|high.||
1213|087|S|   Tell your doctor right away if you have any serious side||
1213|088|S|effects, including: hearing changes (such as ringing in the||
1213|089|S|ears), mental/mood changes, vision changes, easy||
1213|090|S|bruising/bleeding, unexplained stiff neck, signs of kidney||
1213|091|S|problems (such as change in the amount of urine), symptoms of||
1213|092|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
1213|093|S|unusual/sudden weight gain).||
1213|094|S|   This drug may rarely cause serious (possibly fatal) liver||
1213|095|S|disease. Get medical help right away if you have any symptoms of||
1213|096|S|liver damage, including: nausea/vomiting that doesn't stop,||
1213|097|S|yellowing eyes/skin, dark urine, severe stomach/abdominal pain.||
1213|098|S|   A very serious allergic reaction to this drug is rare.||
1213|099|S|However, get medical help right away if you notice any symptoms||
1213|100|S|of a serious allergic reaction, including: fever, swollen lymph||
1213|101|S|nodes, rash, itching/swelling (especially of the||
1213|102|S|face/tongue/throat), severe dizziness, trouble breathing.||
1213|103|S|   This is not a complete list of possible side effects. If you||
1213|104|S|notice other effects not listed above, contact your doctor or||
1213|105|S|pharmacist.||
1213|106|S|   In the US -||
1213|107|S|   Call your doctor for medical advice about side effects. You||
1213|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1213|109|S|www.fda.gov/medwatch.||
1213|110|S|   In Canada - Call your doctor for medical advice about side||
1213|111|S|effects. You may report side effects to Health Canada at||
1213|112|S|1-866-234-2345.||
1213|113|B|||
1213|114|P|PRECAUTIONS:  Before using ibuprofen, tell your doctor or||
1213|115|P|pharmacist if you are allergic to it; or to aspirin or other||
1213|116|P|NSAIDs (such as naproxen, celecoxib); or if you have any other||
1213|117|P|allergies. This product may contain inactive ingredients, which||
1213|118|P|can cause allergic reactions or other problems. Talk to your||
1213|119|P|pharmacist for more details.||
1213|120|P|   Before using this medication, tell your doctor or pharmacist||
1213|121|P|your medical history, especially of: liver disease,||
1213|122|P|stomach/intestine/esophagus problems (such as bleeding, ulcers,||
1213|123|P|recurring heartburn), heart disease (such as history of heart||
1213|124|P|attack), high blood pressure, stroke, blood disorders (such as||
1213|125|P|anemia, bleeding/clotting problems), asthma (including a history||
1213|126|P|of worsening breathing after taking aspirin or other NSAIDs),||
1213|127|P|growths in the nose (nasal polyps).||
1213|128|P|   Kidney problems can sometimes occur with the use of NSAID||
1213|129|P|medications, including ibuprofen. Problems are more likely to||
1213|130|P|occur if you are dehydrated, have heart failure or kidney||
1213|131|P|disease, are an older adult, or if you take certain medications||
1213|132|P|(see also Drug Interactions section). Drink plenty of fluids as||
1213|133|P|directed by your doctor to prevent dehydration and tell your||
1213|134|P|doctor right away if you have a change in the amount of urine.||
1213|135|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1213|136|P|can make you more dizzy. Do not drive, use machinery, or do||
1213|137|P|anything that needs alertness until you can do it safely. Talk to||
1213|138|P|your doctor if you are using marijuana (cannabis).||
1213|139|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1213|140|P|and tobacco may increase your risk for stomach bleeding,||
1213|141|P|especially when combined with this medicine. Limit alcohol and||
1213|142|P|stop smoking. Consult your doctor or pharmacist for more||
1213|143|P|information.||
1213|144|P|   Before having surgery, tell your doctor or dentist about all||
1213|145|P|the products you use (including prescription drugs,||
1213|146|P|nonprescription drugs, and herbal products).||
1213|147|P|   This medication may make you more sensitive to the sun. Limit||
1213|148|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1213|149|P|sunscreen and wear protective clothing when outdoors. Tell your||
1213|150|P|doctor right away if you get sunburned or have skin||
1213|151|P|blisters/redness.||
1213|152|P|   Older adults may be at greater risk for stomach/intestinal||
1213|153|P|bleeding, kidney problems, heart attack, and stroke while using||
1213|154|P|this drug.||
1213|155|P|   Before using this medication, women of childbearing age should||
1213|156|P|talk with their doctor(s) about the benefits and risks. Tell your||
1213|157|P|doctor if you are pregnant or if you plan to become pregnant.||
1213|158|P|This medication may harm an unborn baby and cause problems with||
1213|159|P|normal labor/delivery. It is not recommended for use in pregnancy||
1213|160|P|from 20 weeks until delivery. If your doctor decides that you||
1213|161|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1213|162|P|you should use the lowest effective dose for the shortest||
1213|163|P|possible time. You should not use this medication after 30 weeks||
1213|164|P|of pregnancy.||
1213|165|P|   This medication passes into breast milk, but is unlikely to||
1213|166|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1213|167|B|||
1213|168|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1213|169|I|medications work or increase your risk for serious side effects.||
1213|170|I|This document does not contain all possible drug interactions.||
1213|171|I|Keep a list of all the products you use (including||
1213|172|I|prescription/nonprescription drugs and herbal products) and share||
1213|173|I|it with your doctor and pharmacist. Do not start, stop, or change||
1213|174|I|the dosage of any medicines without your doctor's approval.||
1213|175|I|   Some of the products that may interact with this drug include:||
1213|176|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1213|177|I|angiotensin II receptor blockers (such as losartan, valsartan),||
1213|178|I|other medications for arthritis (such as aspirin, methotrexate),||
1213|179|I|cidofovir, corticosteroids (such as prednisone), lithium, "water||
1213|180|I|pills" (diuretics such as furosemide).||
1213|181|I|   This medication may increase the risk of bleeding when used||
1213|182|I|with other drugs that also may cause bleeding. Examples include||
1213|183|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1213|184|I|dabigatran/enoxaparin/warfarin, among others.||
1213|185|I|   Check all prescription and nonprescription medicine labels||
1213|186|I|carefully since many medications contain pain relievers/fever||
1213|187|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
1213|188|I|or naproxen). These drugs are similar to ibuprofen and may||
1213|189|I|increase your risk of side effects if taken together. However, if||
1213|190|I|your doctor has told you to take low-dose aspirin to prevent||
1213|191|I|heart attack or stroke (usually 81-162 milligrams a day), you||
1213|192|I|should keep taking the aspirin unless your doctor tells you not||
1213|193|I|to.||
1213|194|I|   Daily use of ibuprofen may decrease aspirin's ability to||
1213|195|I|prevent heart attack/stroke. Talk to your doctor about using a||
1213|196|I|different medication (such as acetaminophen) to treat pain/fever.||
1213|197|I|If you must use ibuprofen, talk to your doctor about taking||
1213|198|I|immediate-release aspirin (not enteric-coated/EC) while using||
1213|199|I|ibuprofen. Use ibuprofen at least 8 hours before or at least 2||
1213|200|I|hours after your aspirin dose. Do not increase your daily dose of||
1213|201|I|aspirin or change the way you take aspirin/other medications||
1213|202|I|without your doctor's approval.||
1213|203|B|||
1213|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1213|205|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1213|206|O|poison control center right away. US residents can call||
1213|207|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1213|208|O|Symptoms of overdose may include: severe stomach pain, vomit that||
1213|209|O|looks like coffee grounds, extreme drowsiness/dizziness.||
1213|210|B|||
1213|211|N|NOTES:  Do not share this medication with others.||
1213|212|N|   Lab and/or medical tests (such as complete blood count,||
1213|213|N|liver/kidney function, blood pressure) may be done while you are||
1213|214|N|using this medication. Keep all medical and lab appointments.||
1213|215|N|   This medication has been prescribed for your current condition||
1213|216|N|only. Do not use it later for another condition unless told to do||
1213|217|N|so by your doctor. A different medication may be necessary in||
1213|218|N|those cases.||
1213|219|B|||
1213|220|D|MISSED DOSE:  Not applicable.||
1213|221|B|||
1213|222|R|STORAGE:  Store at room temperature. Discard any unused portion||
1213|223|R|after use. Keep all medications away from children and pets.||
1213|224|R|   Do not flush medications down the toilet or pour them into a||
1213|225|R|drain unless instructed to do so. Properly discard this product||
1213|226|R|when it is expired or no longer needed. Consult your pharmacist||
1213|227|R|or local waste disposal company.||
1213|228|B|||
1213|229|A|Information last revised January 2025.||
1213|230|A|Copyright(c) 2025 First Databank, Inc.||
1213|231|B|||
1214|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1214|002|Z|does NOT have all possible information about this product. This||
1214|003|Z|information does not assure that this product is safe, effective,||
1214|004|Z|or appropriate for you. This information is not individual||
1214|005|Z|medical advice and does not substitute for the advice of your||
1214|006|Z|health care professional. Always ask your health care||
1214|007|Z|professional for complete information about this product and your||
1214|008|Z|specific health needs.||
1214|009|B|||
1214|010|T|MINOCYCLINE - INJECTION||
1214|011|F|(MIN-oh-SYE-kleen)||
1214|012|B|||
1214|013|C|COMMON BRAND NAME(S): Minocin||
1214|014|B|||
1214|015|U|USES:  Minocycline is used to treat a wide variety of infections.||
1214|016|U|This medication belongs to a class of drugs known as tetracycline||
1214|017|U|antibiotics. It works by stopping the growth of bacteria.||
1214|018|B|||
1214|019|V|OTHER USES:  This section contains uses of this drug that are not||
1214|020|V|listed in the approved professional labeling for the drug but||
1214|021|V|that may be prescribed by your health care professional. Use this||
1214|022|V|drug for a condition that is listed in this section only if it||
1214|023|V|has been so prescribed by your health care professional.||
1214|024|V|   This drug may also be used for a condition of too much fluid||
1214|025|V|buildup around the lungs (pleural effusion). For this condition,||
1214|026|V|a tube is used to place minocycline in the chest space around the||
1214|027|V|lungs.||
1214|028|B|||
1214|029|H|HOW TO USE:  This medication is given by slow injection into a||
1214|030|H|vein as directed by your doctor, usually every 12 hours over 60||
1214|031|H|minutes. The dosage is based on your medical condition and||
1214|032|H|response to treatment. Children's dosage is also based on weight.||
1214|033|H|   If you are using this medication at home, learn all||
1214|034|H|preparation and usage instructions from your health care||
1214|035|H|professional. Before using, check this product for particles or||
1214|036|H|discoloration. If either is present, do not use the liquid. Learn||
1214|037|H|how to store and discard medical supplies safely.||
1214|038|H|   For the best effect, use this antibiotic at evenly spaced||
1214|039|H|times. To help you remember, use this medication at the same||
1214|040|H|times every day.||
1214|041|H|   Continue to use this medication until the full prescribed||
1214|042|H|amount is finished, even if symptoms disappear after a few days.||
1214|043|H|Stopping the medication too early may result in a return of the||
1214|044|H|infection.||
1214|045|H|   Tell your doctor if your condition lasts or gets worse.||
1214|046|B|||
1214|047|S|SIDE EFFECTS:  Pain, redness, and tenderness at the injection||
1214|048|S|site may occur. Nausea, vomiting, diarrhea, lightheadedness,||
1214|049|S|dizziness, or a feeling of spinning may also occur. If any of||
1214|050|S|these effects last or get worse, tell your doctor or pharmacist||
1214|051|S|promptly.||
1214|052|S|   Remember that this medication has been prescribed because your||
1214|053|S|doctor has judged that the benefit to you is greater than the||
1214|054|S|risk of side effects. Many people using this medication do not||
1214|055|S|have serious side effects.||
1214|056|S|   Tell your doctor right away if you have any serious side||
1214|057|S|effects, including: hearing changes (such as ringing in the ears,||
1214|058|S|decreased hearing), joint stiffness/pain/swelling, signs of||
1214|059|S|kidney problems (such as change in the amount of urine, pink||
1214|060|S|urine), signs of liver problems (such as loss of appetite,||
1214|061|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1214|062|S|yellow-gray-brown tooth discoloration, blue-gray||
1214|063|S|skin/lips/tongue/gums.||
1214|064|S|   Minocycline may rarely cause increased pressure around the||
1214|065|S|brain (intracranial hypertension-IH). The risk of this side||
1214|066|S|effect is greater for women of childbearing age who are||
1214|067|S|overweight or who have had IH in the past. If IH develops, it||
1214|068|S|usually goes away after minocycline is stopped; however, there is||
1214|069|S|a chance of permanent vision loss or blindness. Get medical help||
1214|070|S|right away if you have: severe/lasting headache, vision changes||
1214|071|S|(such as blurred/double vision, decreased vision, sudden||
1214|072|S|blindness), nausea/vomiting that doesn't stop.||
1214|073|S|   This medication may rarely cause a severe intestinal condition||
1214|074|S|due to a bacteria called C. difficile. This condition may occur||
1214|075|S|during treatment or weeks to months after treatment has stopped.||
1214|076|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1214|077|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1214|078|S|stool.||
1214|079|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1214|080|S|products because they may make symptoms worse.||
1214|081|S|   Use of this medication for prolonged or repeated periods may||
1214|082|S|result in oral thrush or a new yeast infection. Contact your||
1214|083|S|doctor if you notice white patches in your mouth, a change in||
1214|084|S|vaginal discharge, or other new symptoms.||
1214|085|S|   A very serious allergic reaction to this drug is rare.||
1214|086|S|However, get medical help right away if you notice any symptoms||
1214|087|S|of a serious allergic reaction, including: fever that doesn't go||
1214|088|S|away, new or worsening lymph node swelling, rash,||
1214|089|S|itching/swelling (especially of the face/tongue/throat), severe||
1214|090|S|dizziness, trouble breathing.||
1214|091|S|   This is not a complete list of possible side effects. If you||
1214|092|S|notice other effects not listed above, contact your doctor or||
1214|093|S|pharmacist.||
1214|094|S|   In the US -||
1214|095|S|   Call your doctor for medical advice about side effects. You||
1214|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1214|097|S|www.fda.gov/medwatch.||
1214|098|S|   In Canada - Call your doctor for medical advice about side||
1214|099|S|effects. You may report side effects to Health Canada at||
1214|100|S|1-866-234-2345.||
1214|101|B|||
1214|102|P|PRECAUTIONS:  See also Side Effects section.||
1214|103|P|   Before using minocycline, tell your doctor or pharmacist if||
1214|104|P|you are allergic to it; or to other tetracyclines (such as||
1214|105|P|doxycycline); or if you have any other allergies. This product||
1214|106|P|may contain inactive ingredients, which can cause allergic||
1214|107|P|reactions or other problems. Talk to your pharmacist for more||
1214|108|P|details.||
1214|109|P|   Before using this medication, tell your doctor or pharmacist||
1214|110|P|your medical history, especially of: kidney problems, liver||
1214|111|P|problems.||
1214|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1214|113|P|can make you more dizzy. Do not drive, use machinery, or do||
1214|114|P|anything that needs alertness until you can do it safely. Limit||
1214|115|P|alcoholic beverages. Talk to your doctor if you are using||
1214|116|P|marijuana (cannabis).||
1214|117|P|   This medication may make you more sensitive to the sun. Limit||
1214|118|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1214|119|P|sunscreen and wear protective clothing when outdoors. Tell your||
1214|120|P|doctor right away if you get sunburned or have skin||
1214|121|P|blisters/redness.||
1214|122|P|   Minocycline may cause live bacterial vaccines (such as typhoid||
1214|123|P|vaccine) to not work well. Tell your health care professional||
1214|124|P|that you are using minocycline before having any||
1214|125|P|immunizations/vaccinations.||
1214|126|P|   Before having surgery, tell your doctor or dentist about all||
1214|127|P|the products you use (including prescription drugs,||
1214|128|P|nonprescription drugs, and herbal products).||
1214|129|P|   Children younger than 8 years may be more sensitive to the||
1214|130|P|side effects of minocycline, especially tooth discoloration.||
1214|131|P|Tooth discoloration has also occurred in older children and in||
1214|132|P|young adults. Discuss the risks and benefits of this medication||
1214|133|P|with the doctor.||
1214|134|P|   Tell your doctor if you are pregnant or plan to become||
1214|135|P|pregnant. You should not become pregnant while using minocycline.||
1214|136|P|Minocycline may harm an unborn baby. If you become pregnant, talk||
1214|137|P|to your doctor right away about the risks and benefits of this||
1214|138|P|medication.||
1214|139|P|   This medication passes into breast milk. Consult your doctor||
1214|140|P|before breastfeeding.||
1214|141|B|||
1214|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1214|143|I|medications work or increase your risk for serious side effects.||
1214|144|I|This document does not contain all possible drug interactions.||
1214|145|I|Keep a list of all the products you use (including||
1214|146|I|prescription/nonprescription drugs and herbal products) and share||
1214|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
1214|148|I|the dosage of any medicines without your doctor's approval.||
1214|149|I|   Some products that may interact with this drug are: retinoid||
1214|150|I|medications taken by mouth (such as acitretin, isotretinoin).||
1214|151|I|   This medication may interfere with certain lab tests (such as||
1214|152|I|urine catecholamine levels), possibly causing false test results.||
1214|153|I|Make sure lab personnel and all your doctors know you use this||
1214|154|I|drug.||
1214|155|B|||
1214|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1214|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1214|158|O|poison control center right away. US residents can call||
1214|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1214|160|B|||
1214|161|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1214|162|N|kidney/liver function) may be done while you are using this||
1214|163|N|medication. Keep all medical and lab appointments.||
1214|164|B|||
1214|165|D|MISSED DOSE:  It is important to get each dose of this medication||
1214|166|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1214|167|D|right away for a new dosing schedule. Do not double the dose to||
1214|168|D|catch up.||
1214|169|B|||
1214|170|R|STORAGE:  Consult the product instructions or your pharmacist for||
1214|171|R|storage details. Keep all medications away from children and||
1214|172|R|pets.||
1214|173|R|   Do not flush medications down the toilet or pour them into a||
1214|174|R|drain unless instructed to do so. Properly discard this product||
1214|175|R|when it is expired or no longer needed. Consult your pharmacist||
1214|176|R|or local waste disposal company.||
1214|177|B|||
1214|178|A|Information last revised December 2024.||
1214|179|A|Copyright(c) 2025 First Databank, Inc.||
1214|180|B|||
1215|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1215|002|Z|does NOT have all possible information about this product. This||
1215|003|Z|information does not assure that this product is safe, effective,||
1215|004|Z|or appropriate for you. This information is not individual||
1215|005|Z|medical advice and does not substitute for the advice of your||
1215|006|Z|health care professional. Always ask your health care||
1215|007|Z|professional for complete information about this product and your||
1215|008|Z|specific health needs.||
1215|009|B|||
1215|010|T|TADALAFIL (LUNGS) - ORAL||
1215|011|F|(ta-DA-la-fil)||
1215|012|B|||
1215|013|C|COMMON BRAND NAME(S): Adcirca, Alyq, Tadliq||
1215|014|B|||
1215|015|U|USES:  Tadalafil is used to treat high blood pressure in the||
1215|016|U|lungs (pulmonary hypertension). It works by relaxing and widening||
1215|017|U|the blood vessels in your lungs which allows the blood to flow||
1215|018|U|more easily. Decreasing high blood pressure in the lungs allows||
1215|019|U|your heart and lungs to work better and improves your ability to||
1215|020|U|exercise.||
1215|021|B|||
1215|022|V|OTHER USES:  This section contains uses of this drug that are not||
1215|023|V|listed in the approved professional labeling for the drug but||
1215|024|V|that may be prescribed by your health care professional. Use this||
1215|025|V|drug for a condition that is listed in this section only if it||
1215|026|V|has been so prescribed by your health care professional.||
1215|027|V|   Tadalafil is also available in another brand for erectile||
1215|028|V|dysfunction-ED in men. It may also be used for symptoms of an||
1215|029|V|enlarged prostate (benign prostatic hyperplasia-BPH).||
1215|030|B|||
1215|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1215|032|H|from your pharmacist before you start taking tadalafil and each||
1215|033|H|time you get a refill. If you have any questions, ask your doctor||
1215|034|H|or pharmacist.||
1215|035|H|   To treat high blood pressure in the lungs, take this||
1215|036|H|medication by mouth with or without food as directed by your||
1215|037|H|doctor, usually once daily.||
1215|038|H|   If you are using the liquid form of this medication, shake the||
1215|039|H|bottle well for 30 seconds before each dose. Carefully measure||
1215|040|H|the dose using a special measuring device/spoon. Do not use a||
1215|041|H|household spoon because you may not get the correct dose.||
1215|042|H|   The dosage is based on your medical condition, response to||
1215|043|H|treatment, and other medications you may be taking. Be sure to||
1215|044|H|tell your doctor and pharmacist about all the products you use||
1215|045|H|(including prescription drugs, nonprescription drugs, and herbal||
1215|046|H|products).||
1215|047|H|   Take this medication regularly to get the most benefit from||
1215|048|H|it. To help you remember, take it at the same time each day.||
1215|049|H|   Tell your doctor if your condition does not get better or if||
1215|050|H|it gets worse.||
1215|051|B|||
1215|052|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, muscle pain,||
1215|053|S|flushing, nausea, stuffy nose, or stomach upset may occur. If any||
1215|054|S|of these effects last or get worse, tell your doctor or||
1215|055|S|pharmacist promptly.||
1215|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
1215|057|S|slowly when rising from a sitting or lying position.||
1215|058|S|   Remember that this medication has been prescribed because your||
1215|059|S|doctor has judged that the benefit to you is greater than the||
1215|060|S|risk of side effects. Many people using this medication do not||
1215|061|S|have serious side effects.||
1215|062|S|   Rarely, sudden decreased vision, including permanent||
1215|063|S|blindness, in one or both eyes (NAION) may occur. If this serious||
1215|064|S|problem occurs, stop taking tadalafil and get medical help right||
1215|065|S|away. You have a slightly greater chance of developing NAION if||
1215|066|S|you have heart disease, diabetes, high cholesterol, certain other||
1215|067|S|eye problems ("crowded disk"), high blood pressure, if you are||
1215|068|S|over 50, or if you smoke.||
1215|069|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
1215|070|S|ringing in the ears and dizziness, may occur. Stop taking||
1215|071|S|tadalafil and get medical help right away if these effects occur.||
1215|072|S|   Rarely, males may have a painful or prolonged erection lasting||
1215|073|S|4 or more hours. If this occurs, stop using this drug and get||
1215|074|S|medical help right away, or permanent problems could occur.||
1215|075|S|   Get medical help right away if you have any very serious side||
1215|076|S|effects, including: increased shortness of breath or trouble||
1215|077|S|breathing.||
1215|078|S|   A very serious allergic reaction to this drug is rare.||
1215|079|S|However, get medical help right away if you notice any symptoms||
1215|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1215|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1215|082|S|breathing.||
1215|083|S|   This is not a complete list of possible side effects. If you||
1215|084|S|notice other effects not listed above, contact your doctor or||
1215|085|S|pharmacist.||
1215|086|S|   In the US -||
1215|087|S|   Call your doctor for medical advice about side effects. You||
1215|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1215|089|S|www.fda.gov/medwatch.||
1215|090|S|   In Canada - Call your doctor for medical advice about side||
1215|091|S|effects. You may report side effects to Health Canada at||
1215|092|S|1-866-234-2345.||
1215|093|B|||
1215|094|P|PRECAUTIONS:  Before taking tadalafil, tell your doctor or||
1215|095|P|pharmacist if you are allergic to it; or if you have any other||
1215|096|P|allergies. This product may contain inactive ingredients, which||
1215|097|P|can cause allergic reactions or other problems. Talk to your||
1215|098|P|pharmacist for more details.||
1215|099|P|   Before using this medication, tell your doctor or pharmacist||
1215|100|P|your medical history, especially of: heart problems (such as||
1215|101|P|heart attack or life-threatening irregular heartbeat in the past||
1215|102|P|6 months, chest pain/angina, heart failure), stroke in the past 6||
1215|103|P|months, kidney disease, liver disease, high or low blood||
1215|104|P|pressure, dehydration, penis conditions (such as angulation,||
1215|105|P|fibrosis/scarring, Peyronie's disease), history of||
1215|106|P|painful/prolonged erection (priapism), conditions that may||
1215|107|P|increase the risk of priapism (such as sickle cell anemia,||
1215|108|P|leukemia, multiple myeloma), eye problems (such as retinitis||
1215|109|P|pigmentosa, sudden decreased vision, NAION), bleeding disorders,||
1215|110|P|active stomach ulcers, other lung conditions (such as pulmonary||
1215|111|P|veno-occlusive disease).||
1215|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1215|113|P|can make you more dizzy. Do not drive, use machinery, or do||
1215|114|P|anything that needs alertness until you can do it safely. Limit||
1215|115|P|alcoholic beverages. Talk to your doctor if you are using||
1215|116|P|marijuana (cannabis).||
1215|117|P|   Before having surgery, tell your doctor or dentist about all||
1215|118|P|the products you use (including prescription drugs,||
1215|119|P|nonprescription drugs, and herbal products).||
1215|120|P|   During pregnancy, tadalafil should be used only when clearly||
1215|121|P|needed. Discuss the risks and benefits with your doctor.||
1215|122|P|   It is unknown if this medication passes into breast milk.||
1215|123|P|Consult your doctor before breastfeeding.||
1215|124|B|||
1215|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1215|126|I|medications work or increase your risk for serious side effects.||
1215|127|I|This document does not contain all possible drug interactions.||
1215|128|I|Keep a list of all the products you use (including||
1215|129|I|prescription/nonprescription drugs and herbal products) and share||
1215|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
1215|131|I|the dosage of any medicines without your doctor's approval.||
1215|132|I|   Some products that may interact with this drug are: riociguat,||
1215|133|I|vericiguat.||
1215|134|I|   Tadalafil can cause a serious drop in your blood pressure when||
1215|135|I|used with nitrates, which can lead to dizziness, fainting, and||
1215|136|I|rarely heart attack or stroke. Do not use any of the following||
1215|137|I|with tadalafil or within 48 hours of your last dose of tadalafil:||
1215|138|I|certain drugs used to treat chest pain/angina (nitrates such as||
1215|139|I|nitroglycerin, isosorbide), recreational drugs called "poppers"||
1215|140|I|containing amyl or butyl nitrite.||
1215|141|I|   If you are also taking an alpha blocker medication (such as||
1215|142|I|doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high||
1215|143|I|blood pressure, your blood pressure may get too low which can||
1215|144|I|lead to dizziness or fainting. Your doctor may adjust your||
1215|145|I|medications to minimize your risk of low blood pressure.||
1215|146|I|   Other medications can affect the removal of tadalafil from||
1215|147|I|your body, which may affect how tadalafil works. Examples include||
1215|148|I|azole antifungals (such as itraconazole, ketoconazole), macrolide||
1215|149|I|antibiotics (such as clarithromycin, erythromycin), HIV protease||
1215|150|I|inhibitors (such as lopinavir), rifampin, ritonavir, among||
1215|151|I|others.||
1215|152|I|   Do not take this medication with any other product that||
1215|153|I|contains tadalafil or other similar medications for erectile||
1215|154|I|dysfunction-ED or pulmonary hypertension (such as sildenafil,||
1215|155|I|vardenafil).||
1215|156|B|||
1215|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1215|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1215|159|O|poison control center right away. US residents can call||
1215|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1215|161|B|||
1215|162|N|NOTES:  Do not share this medication with others.||
1215|163|B|||
1215|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1215|165|D|remember. If it is near the time of the next dose, skip the||
1215|166|D|missed dose. Take your next dose at the regular time. Do not||
1215|167|D|double the dose to catch up.||
1215|168|B|||
1215|169|R|STORAGE:  Store at room temperature away from light and moisture.||
1215|170|R|Do not store in the bathroom. Keep all medications away from||
1215|171|R|children and pets.||
1215|172|R|   Do not flush medications down the toilet or pour them into a||
1215|173|R|drain unless instructed to do so. Properly discard this product||
1215|174|R|when it is expired or no longer needed. Consult your pharmacist||
1215|175|R|or local waste disposal company.||
1215|176|B|||
1215|177|A|Information last revised October 2024.||
1215|178|A|Copyright(c) 2025 First Databank, Inc.||
1215|179|B|||
1216|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1216|002|Z|does NOT have all possible information about this product. This||
1216|003|Z|information does not assure that this product is safe, effective,||
1216|004|Z|or appropriate for you. This information is not individual||
1216|005|Z|medical advice and does not substitute for the advice of your||
1216|006|Z|health care professional. Always ask your health care||
1216|007|Z|professional for complete information about this product and your||
1216|008|Z|specific health needs.||
1216|009|B|||
1216|010|T|PRASUGREL - ORAL||
1216|011|F|(PRA-soo-grel)||
1216|012|B|||
1216|013|C|COMMON BRAND NAME(S): Effient||
1216|014|B|||
1216|015|W|WARNING:  Prasugrel can rarely cause very serious (possibly||
1216|016|W|fatal) bleeding. Tell your doctor right away if you notice any||
1216|017|W|signs of serious bleeding. See also Side Effects and Precautions||
1216|018|W|sections.||
1216|019|B|||
1216|020|U|USES:  Prasugrel is used with aspirin by patients with heart||
1216|021|U|disease (recent heart attack, unstable angina) who undergo a||
1216|022|U|certain heart procedure (angioplasty). This medication helps to||
1216|023|U|prevent other serious heart/blood vessel problems (such as heart||
1216|024|U|attacks, strokes, blood clots in stents). It works by blocking||
1216|025|U|platelets from sticking together and prevents them from forming||
1216|026|U|harmful blood clots. This "anti-platelet" effect helps to keep||
1216|027|U|blood flowing smoothly in your body.||
1216|028|B|||
1216|029|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1216|030|H|Patient Information Leaflet provided by your pharmacist before||
1216|031|H|you start taking prasugrel and each time you get a refill. If you||
1216|032|H|have any questions, ask your doctor or pharmacist.||
1216|033|H|   Take this medication by mouth with or without food as directed||
1216|034|H|by your doctor, usually once a day. Your doctor may direct you to||
1216|035|H|take this medication with low-dose aspirin (usually 81-162||
1216|036|H|milligrams a day). Follow your doctor's instructions carefully.||
1216|037|H|   The manufacturer directs not to split the tablet before taking||
1216|038|H|it. However, many similar drugs (immediate-release tablets) can||
1216|039|H|be split. Follow your doctor's directions on how to take this||
1216|040|H|medication.||
1216|041|H|   It is very important to take prasugrel exactly as directed. Do||
1216|042|H|not increase your dose or take this medication more often than||
1216|043|H|prescribed. Your condition will not improve any faster, and your||
1216|044|H|risk of side effects will increase. Also, do not stop using this||
1216|045|H|medication unless directed by your doctor.||
1216|046|H|   The dosage is based on your medical condition, weight, and||
1216|047|H|response to treatment.||
1216|048|H|   Use this medication regularly to get the most benefit from it.||
1216|049|H|To help you remember, take it at the same time each day.||
1216|050|B|||
1216|051|S|SIDE EFFECTS:  Headache, nausea, nosebleed, and stomach upset may||
1216|052|S|occur. If any of these effects last or get worse, tell your||
1216|053|S|doctor or pharmacist promptly.||
1216|054|S|   Remember that this medication has been prescribed because your||
1216|055|S|doctor has judged that the benefit to you is greater than the||
1216|056|S|risk of side effects. Many people using this medication do not||
1216|057|S|have serious side effects.||
1216|058|S|   This medication can cause serious bleeding. Tell your doctor||
1216|059|S|right away if you have any signs of serious bleeding, including:||
1216|060|S|nosebleeds that happen often or don't stop, unusual||
1216|061|S|pain/swelling/discomfort, unusual bruising, prolonged bleeding||
1216|062|S|from cuts or gums, unusually heavy/prolonged menstrual flow,||
1216|063|S|coughing up blood, bloody/black/tarry stools, bloody urine, vomit||
1216|064|S|that is bloody or looks like coffee grounds, severe headache,||
1216|065|S|dizziness/fainting, shortness of breath, chest pain, difficulty||
1216|066|S|swallowing.||
1216|067|S|   Prasugrel has rarely caused a certain blood disorder||
1216|068|S|(thrombotic thrombocytopenic purpura). Get medical help right||
1216|069|S|away if you develop symptoms of this blood disorder, including:||
1216|070|S|vision changes, trouble speaking, confusion, yellowing eyes/skin,||
1216|071|S|dark urine, signs of kidney problems (such as change in the||
1216|072|S|amount of urine), unusual weakness/tiredness, unexplained fever.||
1216|073|S|   A very serious allergic reaction to this drug is rare.||
1216|074|S|However, get medical help right away if you notice any symptoms||
1216|075|S|of a serious allergic reaction, including: severe rash,||
1216|076|S|itching/swelling (especially of the face/tongue/throat), severe||
1216|077|S|dizziness, trouble breathing.||
1216|078|S|   This is not a complete list of possible side effects. If you||
1216|079|S|notice other effects not listed above, contact your doctor or||
1216|080|S|pharmacist.||
1216|081|S|   In the US -||
1216|082|S|   Call your doctor for medical advice about side effects. You||
1216|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1216|084|S|www.fda.gov/medwatch.||
1216|085|S|   In Canada - Call your doctor for medical advice about side||
1216|086|S|effects. You may report side effects to Health Canada at||
1216|087|S|1-866-234-2345.||
1216|088|B|||
1216|089|P|PRECAUTIONS:  Before taking prasugrel, tell your doctor or||
1216|090|P|pharmacist if you are allergic to it; or to similar antiplatelet||
1216|091|P|drugs (thienopyridines such as clopidogrel); or if you have any||
1216|092|P|other allergies. This product may contain inactive ingredients,||
1216|093|P|which can cause allergic reactions or other problems. Talk to||
1216|094|P|your pharmacist for more details.||
1216|095|P|   Before using this medication, tell your doctor or pharmacist||
1216|096|P|your medical history, especially of: blood disorders (such as||
1216|097|P|hemophilia), bleeding problems (such as bleeding of the||
1216|098|P|stomach/intestines, bleeding in the brain), blood clots in the||
1216|099|P|brain (stroke, transient ischemic attack-TIA), recent major||
1216|100|P|injury/surgery, liver disease, stomach/intestinal ulcers.||
1216|101|P|   Before having surgery or any medical/dental procedures||
1216|102|P|(including heart bypass surgery-CABG), tell your doctor or||
1216|103|P|dentist about all the products you use (including prescription||
1216|104|P|drugs, nonprescription drugs, and herbal products).||
1216|105|P|   To lower the chance of getting cut, bruised, or injured, use||
1216|106|P|caution with sharp objects like razors and nail cutters, and||
1216|107|P|avoid activities such as contact sports.||
1216|108|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1216|109|P|while using this medicine will increase your risk for stomach||
1216|110|P|bleeding. Limit alcoholic beverages. Ask your doctor or||
1216|111|P|pharmacist about how much alcohol you may safely drink.||
1216|112|P|   Older adults (75 years or older) may be more sensitive to the||
1216|113|P|side effects of this drug, especially bleeding. Discuss the risks||
1216|114|P|and benefits with your doctor.||
1216|115|P|   During pregnancy, this medication should be used only when||
1216|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
1216|117|P|   It is unknown if this medication passes into breast milk.||
1216|118|P|Consult your doctor before breastfeeding.||
1216|119|B|||
1216|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1216|121|I|medications work or increase your risk for serious side effects.||
1216|122|I|This document does not contain all possible drug interactions.||
1216|123|I|Keep a list of all the products you use (including||
1216|124|I|prescription/nonprescription drugs and herbal products) and share||
1216|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1216|126|I|the dosage of any medicines without your doctor's approval.||
1216|127|I|   A product that may interact with this drug is: tipranavir.||
1216|128|I|   This medication is sometimes used together with other drugs||
1216|129|I|that have "blood thinning" or anti-platelet effects, such as||
1216|130|I|aspirin or heparin. When these combinations are prescribed by||
1216|131|I|your doctor, you will require closer monitoring to minimize your||
1216|132|I|risk of bleeding. Keep all medical and lab appointments.||
1216|133|I|   Check all prescription and nonprescription medicine labels||
1216|134|I|carefully since many medications contain pain relievers/fever||
1216|135|I|reducers (aspirin, NSAIDs such as ibuprofen, naproxen) that may||
1216|136|I|increase your risk for bleeding if taken together with this||
1216|137|I|medication. However, if your doctor has told you to take low-dose||
1216|138|I|aspirin to prevent heart attack or stroke (usually 81-162||
1216|139|I|milligrams a day), you should keep taking the aspirin unless your||
1216|140|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1216|141|I|details.||
1216|142|B|||
1216|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1216|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1216|145|O|poison control center right away. US residents can call||
1216|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1216|147|B|||
1216|148|N|NOTES:  Do not share this medication with others.||
1216|149|N|   Lab and/or medical tests (such as complete blood count) should||
1216|150|N|be done while you are taking this medication. Keep all medical||
1216|151|N|and lab appointments. Consult your doctor for more details.||
1216|152|B|||
1216|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1216|154|D|remember. If it is near the time of the next dose, skip the||
1216|155|D|missed dose. Take your next dose at the regular time. Do not||
1216|156|D|double the dose to catch up.||
1216|157|B|||
1216|158|R|STORAGE:  Store in the original bottle at room temperature away||
1216|159|R|from light and moisture. Do not store in the bathroom. Keep the||
1216|160|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1216|161|R|when not in use. Keep all medications away from children and||
1216|162|R|pets.||
1216|163|R|   Do not flush medications down the toilet or pour them into a||
1216|164|R|drain unless instructed to do so. Properly discard this product||
1216|165|R|when it is expired or no longer needed. Consult your pharmacist||
1216|166|R|or local waste disposal company.||
1216|167|B|||
1216|168|M|MEDICAL ALERT:  Your condition can cause complications in a||
1216|169|M|medical emergency. For information about enrolling in MedicAlert,||
1216|170|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1216|171|B|||
1216|172|A|Information last revised July 2024.||
1216|173|A|Copyright(c) 2025 First Databank, Inc.||
1216|174|B|||
1217|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1217|002|Z|does NOT have all possible information about this product. This||
1217|003|Z|information does not assure that this product is safe, effective,||
1217|004|Z|or appropriate for you. This information is not individual||
1217|005|Z|medical advice and does not substitute for the advice of your||
1217|006|Z|health care professional. Always ask your health care||
1217|007|Z|professional for complete information about this product and your||
1217|008|Z|specific health needs.||
1217|009|B|||
1217|010|T|DRONEDARONE - ORAL||
1217|011|F|(DROE-NE-da-rone)||
1217|012|B|||
1217|013|C|COMMON BRAND NAME(S): Multaq||
1217|014|B|||
1217|015|W|WARNING:  Do not take this medication if you have severe heart||
1217|016|W|failure that makes you short of breath during light activity or||
1217|017|W|even while resting, or if you recently had to stay in a hospital||
1217|018|W|because your heart failure got worse. Also, do not take this||
1217|019|W|medication if you have a certain kind of irregular heartbeat||
1217|020|W|(permanent atrial fibrillation) that will not or cannot be||
1217|021|W|changed back to a normal heart rhythm. Dronedarone may increase||
1217|022|W|your risk of death, stroke, or the need to be treated in the||
1217|023|W|hospital for heart failure if you have any of these conditions.||
1217|024|W|Consult your doctor for more details and to discuss the risks and||
1217|025|W|benefits of dronedarone. Tell your doctor right away if you have||
1217|026|W|new or worsening symptoms of heart failure such as shortness of||
1217|027|W|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
1217|028|W|weight gain.||
1217|029|B|||
1217|030|U|USES:  This medication is used if you have had certain types of||
1217|031|U|irregular heartbeat (paroxysmal or persistent atrial||
1217|032|U|fibrillation) in the past but now have a normal heart rhythm. It||
1217|033|U|helps you keep a normal heart rhythm and lowers your chance of||
1217|034|U|having to go to the hospital for atrial fibrillation. Dronedarone||
1217|035|U|is known as an antiarrhythmic drug.||
1217|036|U|   This medication should not be used if you have permanent||
1217|037|U|atrial fibrillation because of the increased risk of very serious||
1217|038|U|side effects. See also Warning section.||
1217|039|B|||
1217|040|H|HOW TO USE:  Read the Medication Guide provided by your||
1217|041|H|pharmacist before you start taking dronedarone and each time you||
1217|042|H|get a refill. If you have any questions, ask your doctor or||
1217|043|H|pharmacist.||
1217|044|H|   Take this medication by mouth with food as directed by your||
1217|045|H|doctor, usually twice daily (once with your morning meal and once||
1217|046|H|with your evening meal).||
1217|047|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1217|048|H|using this medication unless your doctor or pharmacist says you||
1217|049|H|may do so safely. Grapefruit can increase the chance of side||
1217|050|H|effects with this medicine. Ask your doctor or pharmacist for||
1217|051|H|more details.||
1217|052|H|   Take this medication regularly to get the most benefit from||
1217|053|H|it. To help you remember, take it at the same times each day. Do||
1217|054|H|not stop taking dronedarone without asking your doctor first.||
1217|055|H|Keep taking this medication even if you feel well. Your doctor||
1217|056|H|may direct you to also take another medication ("blood||
1217|057|H|thinner"/anticoagulant) to lower the risk of getting serious||
1217|058|H|blood clots. Follow your doctor's instructions carefully.||
1217|059|H|   Get medical help right away if your heartbeat or pulse becomes||
1217|060|H|fast or irregular.||
1217|061|B|||
1217|062|S|SIDE EFFECTS:  See also Warning section.||
1217|063|S|   Nausea or diarrhea may occur. If either of these effects lasts||
1217|064|S|or gets worse, tell your doctor promptly.||
1217|065|S|   Remember that this medication has been prescribed because your||
1217|066|S|doctor has judged that the benefit to you is greater than the||
1217|067|S|risk of side effects. Many people using this medication do not||
1217|068|S|have serious side effects.||
1217|069|S|   Tell your doctor right away if you have any serious side||
1217|070|S|effects, including: symptoms of liver disease (such as||
1217|071|S|nausea/vomiting that doesn't stop, loss of appetite,||
1217|072|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1217|073|S|symptoms of lung problems (such as dry cough that doesn't go||
1217|074|S|away, shortness of breath), signs of kidney problems (such as||
1217|075|S|change in the amount of urine).||
1217|076|S|   Get medical help right away if you have any very serious side||
1217|077|S|effects, including: slow/fast/irregular heartbeat, severe||
1217|078|S|dizziness, fainting.||
1217|079|S|   A very serious allergic reaction to this drug is rare.||
1217|080|S|However, get medical help right away if you notice any symptoms||
1217|081|S|of a serious allergic reaction, including: rash, itching/swelling||
1217|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1217|083|S|breathing.||
1217|084|S|   This is not a complete list of possible side effects. If you||
1217|085|S|notice other effects not listed above, contact your doctor or||
1217|086|S|pharmacist.||
1217|087|S|   In the US -||
1217|088|S|   Call your doctor for medical advice about side effects. You||
1217|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1217|090|S|www.fda.gov/medwatch.||
1217|091|S|   In Canada - Call your doctor for medical advice about side||
1217|092|S|effects. You may report side effects to Health Canada at||
1217|093|S|1-866-234-2345.||
1217|094|B|||
1217|095|P|PRECAUTIONS:  See also Warning section.||
1217|096|P|   Before taking dronedarone, tell your doctor or pharmacist if||
1217|097|P|you are allergic to it; or if you have any other allergies. This||
1217|098|P|product may contain inactive ingredients, which can cause||
1217|099|P|allergic reactions or other problems. Talk to your pharmacist for||
1217|100|P|more details.||
1217|101|P|   Before using this medication, tell your doctor or pharmacist||
1217|102|P|your medical history, especially of: liver disease, certain types||
1217|103|P|of irregular heartbeat (second- or third-degree atrioventricular||
1217|104|P|block or sick sinus syndrome, unless you have a heart pacemaker),||
1217|105|P|serious side effects (such as liver/lung disease) from taking the||
1217|106|P|medication amiodarone.||
1217|107|P|   Dronedarone may cause a condition that affects the heart||
1217|108|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1217|109|P|serious (rarely fatal) fast/irregular heartbeat and other||
1217|110|P|symptoms (such as severe dizziness, fainting) that need medical||
1217|111|P|attention right away.||
1217|112|P|   The risk of QT prolongation may be increased if you have||
1217|113|P|certain medical conditions or are taking other drugs that may||
1217|114|P|cause QT prolongation. Before using dronedarone, tell your doctor||
1217|115|P|or pharmacist of all the drugs you take and if you have any of||
1217|116|P|the following conditions: certain heart problems (heart failure,||
1217|117|P|slow heartbeat, QT prolongation in the EKG), family history of||
1217|118|P|certain heart problems (QT prolongation in the EKG, sudden||
1217|119|P|cardiac death).||
1217|120|P|   Low levels of potassium or magnesium in the blood may also||
1217|121|P|increase your risk of QT prolongation. This risk may increase if||
1217|122|P|you use certain drugs (such as diuretics/"water pills") or if you||
1217|123|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1217|124|P|Talk to your doctor about using dronedarone safely.||
1217|125|P|   Before having surgery, tell your doctor or dentist about all||
1217|126|P|the products you use (including prescription drugs,||
1217|127|P|nonprescription drugs, and herbal products).||
1217|128|P|   Older adults may be more sensitive to the side effects of this||
1217|129|P|drug, especially QT prolongation (see above).||
1217|130|P|   Tell your doctor if you are pregnant or plan to become||
1217|131|P|pregnant. You should not become pregnant while using dronedarone.||
1217|132|P|Dronedarone may harm an unborn baby. Your doctor should order a||
1217|133|P|pregnancy test before you start this medication. Ask about||
1217|134|P|reliable forms of birth control while using this medication and||
1217|135|P|for 5 days after the last dose. If you become pregnant, talk to||
1217|136|P|your doctor right away about the risks and benefits of this||
1217|137|P|medication.||
1217|138|P|   It is unknown if this medication passes into breast milk.||
1217|139|P|Because of the possible risk to the infant, breastfeeding is not||
1217|140|P|recommended while using this medication and for 5 days after the||
1217|141|P|last dose. Consult your doctor before breastfeeding.||
1217|142|B|||
1217|143|I|DRUG INTERACTIONS:  See also How to Use section.||
1217|144|I|   Drug interactions may change how your medications work or||
1217|145|I|increase your risk for serious side effects. This document does||
1217|146|I|not contain all possible drug interactions. Keep a list of all||
1217|147|I|the products you use (including prescription/nonprescription||
1217|148|I|drugs and herbal products) and share it with your doctor and||
1217|149|I|pharmacist. Do not start, stop, or change the dosage of any||
1217|150|I|medicines without your doctor's approval.||
1217|151|I|   A product that may interact with this drug is: fingolimod.||
1217|152|I|   Many drugs besides dronedarone may affect the heart rhythm (QT||
1217|153|I|prolongation). Examples include amiodarone, disopyramide,||
1217|154|I|dofetilide, flecainide, pimozide, procainamide, propafenone,||
1217|155|I|quinidine, sotalol, among others.||
1217|156|I|   Other medications can affect the removal of dronedarone from||
1217|157|I|your body, which may affect how dronedarone works. Examples||
1217|158|I|include azole antifungals (such as ketoconazole, itraconazole,||
1217|159|I|voriconazole), cyclosporine, macrolide antibiotics (such as||
1217|160|I|clarithromycin, erythromycin), nefazodone, HIV protease||
1217|161|I|inhibitors (such as lopinavir), rifampin, ritonavir, St. John's||
1217|162|I|wort, drugs used to treat seizures (such as carbamazepine,||
1217|163|I|phenobarbital, phenytoin), telithromycin, among others.||
1217|164|I|   Dronedarone can slow down the removal of other medications||
1217|165|I|from your body, which may affect how they work. Examples of||
1217|166|I|affected drugs include dabigatran, digoxin, domperidone,||
1217|167|I|elacestrant, flibanserin, taletrectinib, among others.||
1217|168|B|||
1217|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1217|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1217|171|O|poison control center right away. US residents can call||
1217|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1217|173|B|||
1217|174|N|NOTES:  Do not share this medication with others.||
1217|175|N|   Lab and/or medical tests (such as EKG, kidney/liver function,||
1217|176|N|blood mineral levels including potassium) should be done while||
1217|177|N|you are taking this medication. Keep all medical and lab||
1217|178|N|appointments. Consult your doctor for more details.||
1217|179|B|||
1217|180|D|MISSED DOSE:  If you miss a dose, skip the missed dose and take||
1217|181|D|your next dose at your regular scheduled time. Do not double the||
1217|182|D|dose to catch up.||
1217|183|B|||
1217|184|R|STORAGE:  Store at room temperature away from light and moisture.||
1217|185|R|Do not store in the bathroom. Keep all medications away from||
1217|186|R|children and pets.||
1217|187|R|   Do not flush medications down the toilet or pour them into a||
1217|188|R|drain unless instructed to do so. Properly discard this product||
1217|189|R|when it is expired or no longer needed. Consult your pharmacist||
1217|190|R|or local waste disposal company.||
1217|191|B|||
1217|192|M|MEDICAL ALERT:  Your condition can cause complications in a||
1217|193|M|medical emergency. For information about enrolling in MedicAlert,||
1217|194|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1217|195|B|||
1217|196|A|Information last revised June 2025.||
1217|197|A|Copyright(c) 2025 First Databank, Inc.||
1217|198|B|||
1218|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1218|002|Z|does NOT have all possible information about this product. This||
1218|003|Z|information does not assure that this product is safe, effective,||
1218|004|Z|or appropriate for you. This information is not individual||
1218|005|Z|medical advice and does not substitute for the advice of your||
1218|006|Z|health care professional. Always ask your health care||
1218|007|Z|professional for complete information about this product and your||
1218|008|Z|specific health needs.||
1218|009|B|||
1218|010|T|ARTEMETHER/LUMEFANTRINE - ORAL||
1218|011|F|(ar-TEM-e-ther/LOO-me-FAN-treen)||
1218|012|B|||
1218|013|C|COMMON BRAND NAME(S): Coartem||
1218|014|B|||
1218|015|U|USES:  This medication is used to treat malaria in adults and||
1218|016|U|children. The two ingredients in this medication belong to a||
1218|017|U|class of drugs known as antimalarials. Malaria is an infection||
1218|018|U|caused by mosquito bites received while traveling or living in||
1218|019|U|regions of the world where malaria is common. Malaria parasites||
1218|020|U|enter the body, and live in body tissues such as red blood cells||
1218|021|U|or the liver. This medication is used to kill the malaria||
1218|022|U|parasites living inside red blood cells. In some cases, you may||
1218|023|U|need to take a different medication (such as primaquine) to kill||
1218|024|U|the malaria parasites living in the liver. Both treatments may be||
1218|025|U|needed for a complete cure and to avoid the return of infection||
1218|026|U|(relapse). This product is not used to prevent malaria.||
1218|027|U|   The United States Centers for Disease Control provide updated||
1218|028|U|guidelines and travel recommendations for the prevention and||
1218|029|U|treatment of malaria in different parts of the world. Discuss the||
1218|030|U|most recent information with your doctor before starting||
1218|031|U|treatment with this medication.||
1218|032|B|||
1218|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1218|034|H|from your pharmacist before you start taking this medication and||
1218|035|H|each time you get a refill. If you have any questions, ask your||
1218|036|H|doctor or pharmacist.||
1218|037|H|   Take this medication by mouth with a meal as directed by your||
1218|038|H|doctor, usually twice a day for 3 days (6 doses). On your first||
1218|039|H|day of treatment, take your first dose with food, followed by||
1218|040|H|your second dose 8 hours later. Then each day for the next 2||
1218|041|H|days, take one dose in the morning and one dose in the evening.||
1218|042|H|   It is important to take every dose of this medication with||
1218|043|H|food or milk, infant formula, pudding, porridge, or broth. Food||
1218|044|H|helps this medication work better. Tell your doctor if you are||
1218|045|H|unable to eat.||
1218|046|H|   If you or your child cannot swallow tablets, the||
1218|047|H|artemether/lumefantrine tablets may be crushed and mixed with one||
1218|048|H|or two teaspoons (5 to 10 milliliters) of water in a clean||
1218|049|H|container at the time your dose is due. Do not crush tablets or||
1218|050|H|mix with water in advance. Follow the dose of medication with||
1218|051|H|food or drink (such as whole milk, formula, pudding, broth, or||
1218|052|H|porridge).||
1218|053|H|   If you or your child vomits within 1 to 2 hours of taking this||
1218|054|H|drug, repeat this dose and contact your doctor right away. You||
1218|055|H|will need to make sure you have enough tablets to complete your||
1218|056|H|full course of treatment. If you vomit 2 doses, you may need to||
1218|057|H|be treated with a different medication.||
1218|058|H|   The dosage is based on your medical condition, weight, and||
1218|059|H|response to treatment.||
1218|060|H|   It is very important to keep taking this medication exactly as||
1218|061|H|prescribed by your doctor. Do not take more or less of this drug||
1218|062|H|than prescribed. Do not skip any doses. Continue to take this||
1218|063|H|medication until the full prescribed amount is finished, even if||
1218|064|H|symptoms disappear after a few doses. Skipping doses or stopping||
1218|065|H|the medication too early may make the infection more difficult to||
1218|066|H|treat and result in a return of the infection.||
1218|067|H|   This medication works best when the amount of drug in your||
1218|068|H|body is kept at a constant level. Take this drug at evenly spaced||
1218|069|H|intervals. To help you remember, take it at the same times each||
1218|070|H|day.||
1218|071|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1218|072|H|using this medication unless your doctor or pharmacist says you||
1218|073|H|may do so safely. Grapefruit can increase the chance of side||
1218|074|H|effects with this medicine. Ask your doctor or pharmacist for||
1218|075|H|more details.||
1218|076|H|   Get medical help right away if your symptoms of malaria (such||
1218|077|H|as fever, chills, headache, other flu-like symptoms) last or get||
1218|078|H|worse after 1 to 2 days of taking this medication. If your fever||
1218|079|H|returns after completing this prescription, contact your doctor||
1218|080|H|so that he/she can determine whether the malaria has returned.||
1218|081|H|Quick treatment of malaria is needed to prevent serious, possibly||
1218|082|H|fatal, outcomes.||
1218|083|B|||
1218|084|S|SIDE EFFECTS:  Headache, dizziness, loss of appetite, weakness,||
1218|085|S|fever, chills, tiredness, muscle/joint pain, nausea, vomiting,||
1218|086|S|abdominal pain, cough, and trouble sleeping may occur. If any of||
1218|087|S|these effects last after stopping the medication or if these||
1218|088|S|effects get worse while taking this medication, tell your doctor||
1218|089|S|or pharmacist promptly.||
1218|090|S|   Remember that this medication has been prescribed because your||
1218|091|S|doctor has judged that the benefit to you is greater than the||
1218|092|S|risk of side effects. Many people using this medication do not||
1218|093|S|have serious side effects.||
1218|094|S|   Get medical help right away if you have any very serious side||
1218|095|S|effects, including: chest pain, severe dizziness, fainting,||
1218|096|S|fast/irregular/pounding heartbeat.||
1218|097|S|   A very serious allergic reaction to this drug is rare.||
1218|098|S|However, get medical help right away if you notice any symptoms||
1218|099|S|of a serious allergic reaction, including: rash, itching/swelling||
1218|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1218|101|S|breathing.||
1218|102|S|   This is not a complete list of possible side effects. If you||
1218|103|S|notice other effects not listed above, contact your doctor or||
1218|104|S|pharmacist.||
1218|105|S|   In the US -||
1218|106|S|   Call your doctor for medical advice about side effects. You||
1218|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1218|108|S|www.fda.gov/medwatch.||
1218|109|S|   In Canada - Call your doctor for medical advice about side||
1218|110|S|effects. You may report side effects to Health Canada at||
1218|111|S|1-866-234-2345.||
1218|112|B|||
1218|113|P|PRECAUTIONS:  Before taking artemether/lumefantrine, tell your||
1218|114|P|doctor or pharmacist if you are allergic to artemether or||
1218|115|P|lumefantrine; or if you have any other allergies. This product||
1218|116|P|may contain inactive ingredients, which can cause allergic||
1218|117|P|reactions or other problems. Talk to your pharmacist for more||
1218|118|P|details.||
1218|119|P|   Before using this medication, tell your doctor or pharmacist||
1218|120|P|your medical history, especially of: recent use (within the past||
1218|121|P|month) of any medication to prevent or treat malaria (such as||
1218|122|P|halofantrine, quinine, or quinidine), kidney problems, liver||
1218|123|P|problems.||
1218|124|P|   Artemether/lumefantrine may cause a condition that affects the||
1218|125|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
1218|126|P|serious (rarely fatal) fast/irregular heartbeat and other||
1218|127|P|symptoms (such as severe dizziness, fainting) that need medical||
1218|128|P|attention right away.||
1218|129|P|   The risk of QT prolongation may be increased if you have||
1218|130|P|certain medical conditions or are taking other drugs that may||
1218|131|P|cause QT prolongation. Before using artemether/lumefantrine, tell||
1218|132|P|your doctor or pharmacist of all the drugs you take and if you||
1218|133|P|have any of the following conditions: certain heart problems||
1218|134|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
1218|135|P|family history of certain heart problems (QT prolongation in the||
1218|136|P|EKG, sudden cardiac death).||
1218|137|P|   Low levels of potassium or magnesium in the blood may also||
1218|138|P|increase your risk of QT prolongation. This risk may increase if||
1218|139|P|you use certain drugs (such as diuretics/"water pills") or if you||
1218|140|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1218|141|P|Talk to your doctor about using artemether/lumefantrine safely.||
1218|142|P|   This drug may make you feel dizzy or tired or weak. Alcohol or||
1218|143|P|marijuana (cannabis) can make you more dizzy or tired. Do not||
1218|144|P|drive, use machinery, or do anything that needs alertness until||
1218|145|P|you can do it safely. Limit alcoholic beverages. Talk to your||
1218|146|P|doctor if you are using marijuana (cannabis).||
1218|147|P|   Before having surgery, tell your doctor or dentist about all||
1218|148|P|the products you use (including prescription drugs,||
1218|149|P|nonprescription drugs, and herbal products).||
1218|150|P|   Older adults may be more sensitive to the side effects of this||
1218|151|P|drug, especially QT prolongation (see above).||
1218|152|P|   During pregnancy, this medication should be used only when||
1218|153|P|clearly needed. Discuss the risks and benefits with your doctor.||
1218|154|P|   It is unknown if this medication passes into breast milk.||
1218|155|P|Consult your doctor before breastfeeding.||
1218|156|B|||
1218|157|I|DRUG INTERACTIONS:  See also How to Use section.||
1218|158|I|   Drug interactions may change how your medications work or||
1218|159|I|increase your risk for serious side effects. This document does||
1218|160|I|not contain all possible drug interactions. Keep a list of all||
1218|161|I|the products you use (including prescription/nonprescription||
1218|162|I|drugs and herbal products) and share it with your doctor and||
1218|163|I|pharmacist. Do not start, stop, or change the dosage of any||
1218|164|I|medicines without your doctor's approval.||
1218|165|I|   Be sure to tell your doctor about all medications you take for||
1218|166|I|malaria within the 4 weeks before, during, and after treatment||
1218|167|I|with artemether/lumefantrine. In some cases a serious (possibly||
1218|168|I|fatal) drug interaction may occur.||
1218|169|I|   Many drugs besides artemether/lumefantrine may affect the||
1218|170|I|heart rhythm (QT prolongation), including other antimalarial||
1218|171|I|drugs (such as quinine, quinidine), antiarrhythmic drugs (such as||
1218|172|I|amiodarone, sotalol, procainamide, disopyramide), antipsychotics||
1218|173|I|(such as pimozide, ziprasidone), macrolide antibiotics (such as||
1218|174|I|erythromycin), quinolone antibiotics (such as ciprofloxacin,||
1218|175|I|moxifloxacin), among others.||
1218|176|I|   Other medications can affect the removal of||
1218|177|I|artemether/lumefantrine from your body, which may affect how this||
1218|178|I|product works. Examples include azole antifungals (such as||
1218|179|I|ketoconazole, itraconazole), mefloquine, HIV NNRTIs (such as||
1218|180|I|efavirenz), HIV protease inhibitors (such as nelfinavir),||
1218|181|I|rifamycins (such as rifabutin, rifampin), ritonavir, St. John's||
1218|182|I|wort, some anti-seizure drugs (such as carbamazepine,||
1218|183|I|phenobarbital, phenytoin), among others.||
1218|184|I|   This medication can speed up or slow down the removal of other||
1218|185|I|medications from your body, which may affect how they work.||
1218|186|I|Examples of affected drugs include clomipramine, flecainide,||
1218|187|I|certain beta blockers such as metoprolol, certain tricyclic||
1218|188|I|antidepressants (such as amitriptyline and imipramine), among||
1218|189|I|others.||
1218|190|I|   This medication may decrease the effectiveness of hormonal||
1218|191|I|birth control such as pills, patch, or ring. This could cause||
1218|192|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1218|193|I|use reliable backup birth control methods while using this||
1218|194|I|medication. Also tell your doctor if you have any new spotting or||
1218|195|I|breakthrough bleeding, because these may be signs that your birth||
1218|196|I|control is not working well.||
1218|197|B|||
1218|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1218|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1218|200|O|poison control center right away. US residents can call||
1218|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1218|202|O|Symptoms of overdose may include: severe dizziness, fainting,||
1218|203|O|slow/irregular heartbeat.||
1218|204|B|||
1218|205|N|NOTES:  Do not share this medication with others.||
1218|206|N|   Lab and/or medical tests (such as EKG) should be done before||
1218|207|N|you start taking this medication and while you are taking it.||
1218|208|N|Keep all medical and lab appointments. Consult your doctor for||
1218|209|N|more details.||
1218|210|B|||
1218|211|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1218|212|D|remember. If it is near the time of the next dose, skip the||
1218|213|D|missed dose. Take your next dose at the regular time. Do not||
1218|214|D|double the dose to catch up.||
1218|215|B|||
1218|216|R|STORAGE:  Store at room temperature away from light and moisture.||
1218|217|R|Do not store in bathroom. Keep all medications away from children||
1218|218|R|and pets.||
1218|219|R|   Do not flush medications down the toilet or pour them into a||
1218|220|R|drain unless instructed to do so. Properly discard this product||
1218|221|R|when it is expired or no longer needed. Consult your pharmacist||
1218|222|R|or local waste disposal company.||
1218|223|B|||
1218|224|A|Information last revised May 2025.||
1218|225|A|Copyright(c) 2025 First Databank, Inc.||
1218|226|B|||
1219|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1219|002|Z|does NOT have all possible information about this product. This||
1219|003|Z|information does not assure that this product is safe, effective,||
1219|004|Z|or appropriate for you. This information is not individual||
1219|005|Z|medical advice and does not substitute for the advice of your||
1219|006|Z|health care professional. Always ask your health care||
1219|007|Z|professional for complete information about this product and your||
1219|008|Z|specific health needs.||
1219|009|B|||
1219|010|T|SAXAGLIPTIN - ORAL||
1219|011|F|(SAX-a-GLIP-tin)||
1219|012|B|||
1219|013|C|COMMON BRAND NAME(S): Onglyza||
1219|014|B|||
1219|015|U|USES:  Saxagliptin is used with a proper diet and exercise||
1219|016|U|program to control high blood sugar in people with type 2||
1219|017|U|diabetes. Controlling high blood sugar helps prevent kidney||
1219|018|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1219|019|U|function problems. Proper control of diabetes may also lessen||
1219|020|U|your risk of a heart attack or stroke.||
1219|021|U|   Saxagliptin works by increasing levels of natural substances||
1219|022|U|called incretins. Incretins help to control blood sugar by||
1219|023|U|increasing insulin release, especially after a meal. They also||
1219|024|U|decrease the amount of sugar your liver makes.||
1219|025|B|||
1219|026|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1219|027|H|Patient Information Leaflet provided by your pharmacist before||
1219|028|H|you start using saxagliptin and each time you get a refill. If||
1219|029|H|you have any questions, ask your doctor or pharmacist.||
1219|030|H|   Take this medication by mouth with or without food as directed||
1219|031|H|by your doctor, usually once daily.||
1219|032|H|   The manufacturer directs not to split/cut the tablet before||
1219|033|H|taking it. However, many similar drugs (immediate-release||
1219|034|H|tablets) can be split/cut. Follow your doctor's directions on how||
1219|035|H|to take this medication.||
1219|036|H|   The dosage is based on your medical condition, response to||
1219|037|H|treatment, and other medications you may be taking. Be sure to||
1219|038|H|tell your doctor and pharmacist about all the products you use||
1219|039|H|(including prescription drugs, nonprescription drugs, and herbal||
1219|040|H|products).||
1219|041|H|   Take this medication regularly to get the most benefit from||
1219|042|H|it. To help you remember, take it at the same time each day.||
1219|043|H|Carefully follow the medication treatment plan, meal plan, and||
1219|044|H|exercise program your doctor has recommended.||
1219|045|B|||
1219|046|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1219|047|S|because your doctor has judged that the benefit to you is greater||
1219|048|S|than the risk of side effects. Many people using this medication||
1219|049|S|do not have serious side effects.||
1219|050|S|   Tell your doctor right away if you have any serious side||
1219|051|S|effects, including: joint pain, unusual skin blisters, signs of||
1219|052|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1219|053|S|unusual tiredness, unusual/sudden weight gain).||
1219|054|S|   Saxagliptin does not usually cause low blood sugar||
1219|055|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1219|056|S|prescribed with other diabetes medications, or if you do not get||
1219|057|S|enough calories from food, or if you do unusually heavy exercise.||
1219|058|S|Talk with your doctor or pharmacist about whether the dose of||
1219|059|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1219|060|S|of low blood sugar include sudden sweating, shaking, fast||
1219|061|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1219|062|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1219|063|S|treat low blood sugar. If you don't have these reliable forms of||
1219|064|S|glucose, rapidly raise your blood sugar by eating a quick source||
1219|065|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1219|066|S|juice or non-diet soda. Tell your doctor right away about the||
1219|067|S|reaction and the use of this product. To help prevent low blood||
1219|068|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1219|069|S|Check with your doctor or pharmacist to find out what you should||
1219|070|S|do if you miss a meal.||
1219|071|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1219|072|S|thirst/urination. If these symptoms occur, tell your doctor right||
1219|073|S|away. Your doctor may need to adjust your diabetes medication,||
1219|074|S|exercise program, or diet.||
1219|075|S|   Get medical help right away if you have any very serious side||
1219|076|S|effects, including: signs of disease of the pancreas (such as||
1219|077|S|severe stomach/abdominal pain which may spread to the back,||
1219|078|S|nausea/vomiting that doesn't stop).||
1219|079|S|   A very serious allergic reaction to this drug is rare.||
1219|080|S|However, get medical help right away if you notice any symptoms||
1219|081|S|of a serious allergic reaction, including: rash, itching/swelling||
1219|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1219|083|S|breathing.||
1219|084|S|   This is not a complete list of possible side effects. If you||
1219|085|S|notice other effects not listed above, contact your doctor or||
1219|086|S|pharmacist.||
1219|087|S|   In the US -||
1219|088|S|   Call your doctor for medical advice about side effects. You||
1219|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1219|090|S|www.fda.gov/medwatch.||
1219|091|S|   In Canada - Call your doctor for medical advice about side||
1219|092|S|effects. You may report side effects to Health Canada at||
1219|093|S|1-866-234-2345.||
1219|094|B|||
1219|095|P|PRECAUTIONS:  Before taking saxagliptin, tell your doctor or||
1219|096|P|pharmacist if you are allergic to it; or if you have any other||
1219|097|P|allergies. This product may contain inactive ingredients, which||
1219|098|P|can cause allergic reactions or other problems. Talk to your||
1219|099|P|pharmacist for more details.||
1219|100|P|   Before using this medication, tell your doctor or pharmacist||
1219|101|P|your medical history, especially of: kidney disease, disease of||
1219|102|P|the pancreas (pancreatitis), risk factors for pancreatitis (such||
1219|103|P|as stones in your gallbladder, regular use/abuse of alcohol, high||
1219|104|P|levels of fats/triglycerides in the blood), heart failure.||
1219|105|P|   You may experience blurred vision, dizziness, or drowsiness||
1219|106|P|due to extremely low or high blood sugar. Do not drive, use||
1219|107|P|machinery, or do anything that needs alertness or clear vision||
1219|108|P|until you can do it safely.||
1219|109|P|   Limit alcohol while taking this medication because it can||
1219|110|P|increase your risk of developing low blood sugar and||
1219|111|P|pancreatitis.||
1219|112|P|   It may be harder to control your blood sugar when your body is||
1219|113|P|stressed (such as due to fever, infection, injury, or surgery).||
1219|114|P|Consult your doctor because this may require a change in your||
1219|115|P|treatment plan, medications, or blood sugar testing.||
1219|116|P|   Before having surgery, tell your doctor or dentist about all||
1219|117|P|the products you use (including prescription drugs,||
1219|118|P|nonprescription drugs, and herbal products).||
1219|119|P|   During pregnancy, this medication should be used only when||
1219|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
1219|121|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1219|122|P|your doctor for managing your blood sugar while pregnant. Your||
1219|123|P|doctor may change your diabetes treatment during your pregnancy||
1219|124|P|(such as diet and medications including insulin).||
1219|125|P|   It is unknown if this medication passes into breast milk.||
1219|126|P|Consult your doctor before breastfeeding.||
1219|127|B|||
1219|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1219|129|I|medications work or increase your risk for serious side effects.||
1219|130|I|This document does not contain all possible drug interactions.||
1219|131|I|Keep a list of all the products you use (including||
1219|132|I|prescription/nonprescription drugs and herbal products) and share||
1219|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
1219|134|I|the dosage of any medicines without your doctor's approval.||
1219|135|I|   Other medications can affect the removal of saxagliptin from||
1219|136|I|your body, which may affect how saxagliptin works. Examples||
1219|137|I|include azole antifungals (such as itraconazole, ketoconazole),||
1219|138|I|nefazodone, telithromycin, ritonavir, among others.||
1219|139|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1219|140|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1219|141|I|heartbeat you would usually feel when your blood sugar falls too||
1219|142|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1219|143|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1219|144|I|   Many drugs can affect your blood sugar, making it harder to||
1219|145|I|control. Before you start, stop, or change any medication, talk||
1219|146|I|with your doctor or pharmacist about how the medication may||
1219|147|I|affect your blood sugar. Check your blood sugar regularly as||
1219|148|I|directed and share the results with your doctor. Tell your doctor||
1219|149|I|right away if you have symptoms of high or low blood sugar. (See||
1219|150|I|also Side Effects section.) Your doctor may need to adjust your||
1219|151|I|diabetes medication, exercise program, or diet.||
1219|152|B|||
1219|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1219|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1219|155|O|poison control center right away. US residents can call||
1219|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1219|157|B|||
1219|158|N|NOTES:  Do not share this medication with others.||
1219|159|N|   Attend a diabetes education program to learn more about how to||
1219|160|N|manage your diabetes with medications, diet, exercise, and||
1219|161|N|regular medical exams.||
1219|162|N|   Learn the symptoms of high and low blood sugar and how to||
1219|163|N|treat low blood sugar. Check your blood sugar regularly as||
1219|164|N|directed and share the results with your doctor.||
1219|165|N|   Lab and/or medical tests (such as kidney function, fasting||
1219|166|N|blood glucose, hemoglobin A1c) should be done before you start||
1219|167|N|taking this medication and while you are taking it. Keep all||
1219|168|N|medical and lab appointments. Consult your doctor for more||
1219|169|N|details.||
1219|170|B|||
1219|171|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1219|172|D|remember. If it is near the time of the next dose, skip the||
1219|173|D|missed dose. Take your next dose at the regular time. Do not||
1219|174|D|double the dose to catch up.||
1219|175|B|||
1219|176|R|STORAGE:  Store at room temperature away from light and moisture.||
1219|177|R|Do not store in the bathroom. Keep all medications away from||
1219|178|R|children and pets.||
1219|179|R|   Do not flush medications down the toilet or pour them into a||
1219|180|R|drain unless instructed to do so. Properly discard this product||
1219|181|R|when it is expired or no longer needed. Consult your pharmacist||
1219|182|R|or local waste disposal company.||
1219|183|B|||
1219|184|M|MEDICAL ALERT:  Your condition can cause complications in a||
1219|185|M|medical emergency. For information about enrolling in MedicAlert,||
1219|186|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1219|187|B|||
1219|188|A|Information last revised May 2025.||
1219|189|A|Copyright(c) 2025 First Databank, Inc.||
1219|190|B|||
1221|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1221|002|Z|does NOT have all possible information about this product. This||
1221|003|Z|information does not assure that this product is safe, effective,||
1221|004|Z|or appropriate for you. This information is not individual||
1221|005|Z|medical advice and does not substitute for the advice of your||
1221|006|Z|health care professional. Always ask your health care||
1221|007|Z|professional for complete information about this product and your||
1221|008|Z|specific health needs.||
1221|009|B|||
1221|010|T|PALIPERIDONE - INJECTION||
1221|011|F|(PAL-ee-PER-i-done)||
1221|012|B|||
1221|013|C|COMMON BRAND NAME(S): Erzofri, Invega Sustenna||
1221|014|B|||
1221|015|W|WARNING:  There may be a slightly increased risk of serious,||
1221|016|W|possibly fatal side effects (such as stroke, heart failure,||
1221|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1221|018|W|by older adults with dementia. This medication is not approved||
1221|019|W|for the treatment of dementia-related behavior problems. Discuss||
1221|020|W|the risks and benefits of this medication, as well as other||
1221|021|W|effective and possibly safer treatments for dementia-related||
1221|022|W|behavior problems, with the doctor.||
1221|023|B|||
1221|024|U|USES:  This medication is used to treat certain mental/mood||
1221|025|U|disorders (such as schizophrenia, schizoaffective disorder).||
1221|026|U|Paliperidone belongs to a class of drugs known as atypical||
1221|027|U|antipsychotics. It works by helping to restore the balance of||
1221|028|U|certain natural substances in the brain.||
1221|029|B|||
1221|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1221|031|H|from your pharmacist before you start using paliperidone and each||
1221|032|H|time you get a refill. If you have any questions, ask your doctor||
1221|033|H|or pharmacist.||
1221|034|H|   This medication is given by injection into a muscle (upper arm||
1221|035|H|or buttocks) by a health care professional. It is given as||
1221|036|H|directed by your doctor, usually once a month after the first 1||
1221|037|H|or 2 doses. The dosage is based on your medical condition and||
1221|038|H|response to treatment.||
1221|039|H|   Use this medication regularly to get the most benefit from it.||
1221|040|H|To help you remember, mark your calendar with a reminder.||
1221|041|H|   Keep using this medication exactly as prescribed, even if you||
1221|042|H|are feeling better and thinking more clearly. Do not stop using||
1221|043|H|this medication without first consulting your doctor.||
1221|044|H|   Tell your doctor if your condition lasts or gets worse.||
1221|045|B|||
1221|046|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, weight||
1221|047|S|gain, or pain/redness/swelling at the injection site may occur.||
1221|048|S|If any of these effects last or get worse, tell your doctor||
1221|049|S|promptly.||
1221|050|S|   Dizziness and lightheadedness can increase the risk of||
1221|051|S|falling. These effects are more likely to occur in the first few||
1221|052|S|days after starting/restarting the drug or after your dose||
1221|053|S|increases. Get up slowly when rising from a sitting or lying||
1221|054|S|position.||
1221|055|S|   Remember that this medication has been prescribed because your||
1221|056|S|doctor has judged that the benefit to you is greater than the||
1221|057|S|risk of side effects. Many people using this medication do not||
1221|058|S|have serious side effects.||
1221|059|S|   Tell your doctor right away if you have any serious side||
1221|060|S|effects, including: difficulty swallowing, restlessness, muscle||
1221|061|S|spasms, interrupted breathing during sleep.||
1221|062|S|   Get medical help right away if you have any very serious side||
1221|063|S|effects, including: fainting, severe dizziness, slow heartbeat,||
1221|064|S|seizures.||
1221|065|S|   Paliperidone may rarely cause a condition known as tardive||
1221|066|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1221|067|S|your doctor right away if you develop any unusual/uncontrolled||
1221|068|S|movements (especially of the face, lips, mouth, tongue, arms, or||
1221|069|S|legs).||
1221|070|S|   This medication may rarely cause a very serious condition||
1221|071|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1221|072|S|right away if you have any of the following symptoms: fever,||
1221|073|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1221|074|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1221|075|S|signs of kidney problems (such as change in the amount of urine).||
1221|076|S|   This drug may rarely make your blood sugar rise, which can||
1221|077|S|cause or worsen diabetes. Tell your doctor right away if you have||
1221|078|S|symptoms of high blood sugar such as increased thirst/urination.||
1221|079|S|If you already have diabetes, check your blood sugar regularly as||
1221|080|S|directed and share the results with your doctor. Your doctor may||
1221|081|S|need to adjust your diabetes medication, exercise program, or||
1221|082|S|diet.||
1221|083|S|   This drug may also cause significant weight gain and a rise in||
1221|084|S|your blood cholesterol (or triglyceride) levels. These effects,||
1221|085|S|along with diabetes, may increase your risk for developing heart||
1221|086|S|disease. Discuss the risks and benefits of treatment with your||
1221|087|S|doctor. (See also Notes section.)||
1221|088|S|   Rarely, this medication may increase your blood level of a||
1221|089|S|certain hormone (prolactin). In females, an increase in prolactin||
1221|090|S|levels may result in unwanted breast milk, missed/stopped||
1221|091|S|periods, or difficulty becoming pregnant. In males, it may result||
1221|092|S|in decreased sexual ability, inability to produce sperm, or||
1221|093|S|enlarged breasts. If you develop any of these symptoms, tell your||
1221|094|S|doctor right away.||
1221|095|S|   Rarely, males may have a painful or prolonged erection lasting||
1221|096|S|4 or more hours. If this occurs, stop using this drug and get||
1221|097|S|medical help right away, or permanent problems could occur.||
1221|098|S|   A very serious allergic reaction to this drug is rare.||
1221|099|S|However, get medical help right away if you notice any symptoms||
1221|100|S|of a serious allergic reaction, including: fever, swollen lymph||
1221|101|S|nodes, rash, itching/swelling (especially of the||
1221|102|S|face/tongue/throat), severe dizziness, trouble breathing.||
1221|103|S|   This is not a complete list of possible side effects. If you||
1221|104|S|notice other effects not listed above, contact your doctor or||
1221|105|S|pharmacist.||
1221|106|S|   In the US -||
1221|107|S|   Call your doctor for medical advice about side effects. You||
1221|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1221|109|S|www.fda.gov/medwatch.||
1221|110|S|   In Canada - Call your doctor for medical advice about side||
1221|111|S|effects. You may report side effects to Health Canada at||
1221|112|S|1-866-234-2345.||
1221|113|B|||
1221|114|P|PRECAUTIONS:  See also Warnings section.||
1221|115|P|   Before using paliperidone, tell your doctor or pharmacist if||
1221|116|P|you are allergic to it; or to risperidone; or if you have any||
1221|117|P|other allergies. This product may contain inactive ingredients,||
1221|118|P|which can cause allergic reactions or other problems. Talk to||
1221|119|P|your pharmacist for more details.||
1221|120|P|   Before using this medication, tell your doctor or pharmacist||
1221|121|P|your medical history, especially of: kidney disease, low white||
1221|122|P|blood cell count (leukopenia), seizures, Parkinson's disease,||
1221|123|P|dementia, certain eye problems (cataracts, glaucoma), personal or||
1221|124|P|family history of diabetes, high cholesterol/triglyceride levels,||
1221|125|P|heart disease (such as previous heart attack), breathing trouble||
1221|126|P|during sleep (sleep apnea).||
1221|127|P|   Paliperidone may cause a condition that affects the heart||
1221|128|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1221|129|P|serious (rarely fatal) fast/irregular heartbeat and other||
1221|130|P|symptoms (such as severe dizziness, fainting) that need medical||
1221|131|P|attention right away.||
1221|132|P|   The risk of QT prolongation may be increased if you have||
1221|133|P|certain medical conditions or are taking other drugs that may||
1221|134|P|cause QT prolongation. Before using paliperidone, tell your||
1221|135|P|doctor or pharmacist of all the drugs you take and if you have||
1221|136|P|any of the following conditions: certain heart problems (heart||
1221|137|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1221|138|P|history of certain heart problems (QT prolongation in the EKG,||
1221|139|P|sudden cardiac death).||
1221|140|P|   Low levels of potassium or magnesium in the blood may also||
1221|141|P|increase your risk of QT prolongation. This risk may increase if||
1221|142|P|you use certain drugs (such as diuretics/"water pills") or if you||
1221|143|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1221|144|P|Talk to your doctor about using paliperidone safely.||
1221|145|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1221|146|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1221|147|P|machinery, or do anything that needs alertness until you can do||
1221|148|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1221|149|P|are using marijuana (cannabis).||
1221|150|P|   This medication may make you sweat less, making you more||
1221|151|P|likely to get heat stroke. Avoid doing things that may cause you||
1221|152|P|to overheat, such as hard work or exercise in hot weather, or||
1221|153|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1221|154|P|and dress lightly. If you overheat, quickly look for a place to||
1221|155|P|cool down and rest. Get medical help right away if you have a||
1221|156|P|fever that does not go away, mental/mood changes, headache, or||
1221|157|P|dizziness.||
1221|158|P|   Before having surgery (including cataract/glaucoma eye||
1221|159|P|surgery), tell your doctor or dentist if you are using or have||
1221|160|P|ever used this medication, and about all the other products you||
1221|161|P|use (including prescription drugs, nonprescription drugs, and||
1221|162|P|herbal products).||
1221|163|P|   Older adults may be more sensitive to the side effects of this||
1221|164|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
1221|165|P|prolongation (see above). Drowsiness, dizziness, and||
1221|166|P|lightheadedness can increase the risk of falling.||
1221|167|P|   During pregnancy, this medication should be used only when||
1221|168|P|clearly needed. Babies born to mothers who have used this drug||
1221|169|P|during the last 3 months of pregnancy may rarely develop symptoms||
1221|170|P|including muscle stiffness or shakiness, drowsiness,||
1221|171|P|feeding/breathing difficulties, or constant crying. If you notice||
1221|172|P|any of these symptoms in your newborn especially during their||
1221|173|P|first month, tell the doctor right away.||
1221|174|P|   Since untreated mental/mood problems (such as schizophrenia,||
1221|175|P|schizoaffective disorders) can be a serious condition, do not||
1221|176|P|stop taking this medication unless directed by your doctor. If||
1221|177|P|you are planning pregnancy, become pregnant, or think you may be||
1221|178|P|pregnant, immediately discuss with your doctor the benefits and||
1221|179|P|risks of using this medication during pregnancy.||
1221|180|P|   This medication passes into breast milk and may have||
1221|181|P|undesirable effects on a nursing infant. Tell the doctor right||
1221|182|P|away if your baby develops symptoms such as muscle stiffness or||
1221|183|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
1221|184|P|your doctor before breastfeeding.||
1221|185|B|||
1221|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1221|187|I|medications work or increase your risk for serious side effects.||
1221|188|I|This document does not contain all possible drug interactions.||
1221|189|I|Keep a list of all the products you use (including||
1221|190|I|prescription/nonprescription drugs and herbal products) and share||
1221|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
1221|192|I|the dosage of any medicines without your doctor's approval.||
1221|193|I|   A product that may interact with this drug is: metoclopramide.||
1221|194|I|   Many drugs besides paliperidone may affect the heart rhythm||
1221|195|I|(QT prolongation), including amiodarone, chlorpromazine,||
1221|196|I|moxifloxacin, quinidine, sotalol, procainamide, thioridazine,||
1221|197|I|among others.||
1221|198|I|   Tell your doctor or pharmacist if you are taking other||
1221|199|I|products that cause drowsiness such as opioid pain or cough||
1221|200|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1221|201|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1221|202|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1221|203|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1221|204|I|diphenhydramine).||
1221|205|I|   Check the labels on all your medicines (such as allergy or||
1221|206|I|cough-and-cold products) because they may contain ingredients||
1221|207|I|that cause drowsiness. Ask your pharmacist about using those||
1221|208|I|products safely.||
1221|209|B|||
1221|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1221|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1221|212|O|poison control center right away. US residents can call||
1221|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1221|214|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
1221|215|O|fast/irregular heartbeat, muscle stiffness/spasms, restlessness,||
1221|216|O|unusual/uncontrolled movements.||
1221|217|B|||
1221|218|N|NOTES:  Lab and/or medical tests (such as fasting blood sugar,||
1221|219|N|kidney function, cholesterol/triglyceride levels, blood pressure,||
1221|220|N|weight) may be done while you are using this medication. Keep all||
1221|221|N|medical and lab appointments. Consult your doctor for more||
1221|222|N|details.||
1221|223|B|||
1221|224|D|MISSED DOSE:  It is important to get each dose of this medication||
1221|225|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1221|226|D|right away for a new dosing schedule.||
1221|227|B|||
1221|228|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1221|229|R|doctor's office and will not be stored at home.||
1221|230|B|||
1221|231|A|Information last revised October 2024.||
1221|232|A|Copyright(c) 2025 First Databank, Inc.||
1221|233|B|||
1222|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1222|002|Z|does NOT have all possible information about this product. This||
1222|003|Z|information does not assure that this product is safe, effective,||
1222|004|Z|or appropriate for you. This information is not individual||
1222|005|Z|medical advice and does not substitute for the advice of your||
1222|006|Z|health care professional. Always ask your health care||
1222|007|Z|professional for complete information about this product and your||
1222|008|Z|specific health needs.||
1222|009|B|||
1222|010|T|FORMOTEROL POWDER INHALER - ORAL INHALATION||
1222|011|F|(for-MOE-ter-ol)||
1222|012|B|||
1222|013|W|WARNING:  Rarely, in patients treated for asthma, serious||
1222|014|W|(sometimes fatal) asthma-related breathing problems have occurred||
1222|015|W|with the use of long-acting inhaled beta agonists (such as||
1222|016|W|salmeterol). Because formoterol is similar to salmeterol, it may||
1222|017|W|also cause these problems. In patients with asthma, this drug||
1222|018|W|should only be prescribed when one long-term medication (such as||
1222|019|W|inhaled corticosteroids) does not control breathing problems or||
1222|020|W|when more than one long-term medication is clearly needed to||
1222|021|W|control breathing problems. Formoterol must not be used alone to||
1222|022|W|treat asthma. Before using this medication, it is important to||
1222|023|W|learn how to use it properly. Discuss the risks and benefits of||
1222|024|W|treatment with this medication with your doctor.||
1222|025|W|   Once asthma symptoms are controlled, if possible, your doctor||
1222|026|W|may stop treatment with formoterol and continue only your other||
1222|027|W|asthma medications (such as inhaled corticosteroids). Follow your||
1222|028|W|doctor's directions carefully.||
1222|029|B|||
1222|030|U|USES:  Formoterol is used to improve breathing problems such as||
1222|031|U|asthma. It is used on a regular schedule to help reduce wheezing,||
1222|032|U|coughing, and shortness of breath. It should only be used||
1222|033|U|long-term if your asthma symptoms are not controlled by your||
1222|034|U|other asthma medications (such as inhaled corticosteroids).||
1222|035|U|Formoterol must not be used alone to treat asthma. (See also||
1222|036|U|Warning section.) It works by relaxing the muscles around the||
1222|037|U|airways so that they open up and you can breathe more easily. It||
1222|038|U|belongs to the class of drugs known as long-acting beta-agonist||
1222|039|U|bronchodilators. Controlling symptoms of breathing problems can||
1222|040|U|decrease time lost from work or school.||
1222|041|U|   This drug is also used to prevent breathing trouble brought on||
1222|042|U|by exercise.||
1222|043|U|   Formoterol should be used with corticosteroids. However, it||
1222|044|U|should not be used with other long-acting beta-agonist inhalers||
1222|045|U|(such as arformoterol, salmeterol) because doing so may increase||
1222|046|U|your risk for side effects.||
1222|047|U|   This medication should not be used to treat a sudden asthma||
1222|048|U|attack. Your doctor may direct you instead to treat sudden asthma||
1222|049|U|attacks with a short-acting, quick-relief inhaler (such as||
1222|050|U|salbutamol, also called albuterol in some countries). Consult||
1222|051|U|your doctor or pharmacist to make sure you know what to do and||
1222|052|U|which medications to use if an asthma attack occurs.||
1222|053|U|   It is recommended that children and teenagers, who need to use||
1222|054|U|formoterol to treat their asthma, should use a combination||
1222|055|U|formoterol/budesonide product. Check with your child's doctor to||
1222|056|U|see if this product is the right product for your child.||
1222|057|B|||
1222|058|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1222|059|H|from your pharmacist before you start using formoterol and each||
1222|060|H|time you get a refill. Learn how to use formoterol properly. If||
1222|061|H|you have any questions, ask your doctor or pharmacist.||
1222|062|H|   If you are using short-acting bronchodilators such as||
1222|063|H|albuterol or salbutamol on a regular schedule every day (such as||
1222|064|H|every 6 hours), stop that treatment when you start formoterol.||
1222|065|H|However, continue to use albuterol or salbutamol to relieve||
1222|066|H|sudden asthma attacks if your doctor has directed you to do so.||
1222|067|H|Ask your doctor if you have any questions.||
1222|068|H|   Inhale this medication by mouth as directed by your doctor,||
1222|069|H|usually twice daily (about every 12 hours). Breathe in forcefully||
1222|070|H|and deeply through the mouthpiece. Remove the inhaler from your||
1222|071|H|mouth before breathing out. Do not exhale into the device.||
1222|072|H|   The dosage is based on your medical condition and response to||
1222|073|H|treatment. If your doctor has directed you to use 2 inhalations,||
1222|074|H|wait at least 1 minute between them. If you are using other||
1222|075|H|inhalers at the same time, wait at least 1 minute between the use||
1222|076|H|of each medication.||
1222|077|H|   Use this medication regularly to get the most benefit from it.||
1222|078|H|This medication works best if used at evenly spaced intervals. To||
1222|079|H|help you remember, use it at the same times each day.||
1222|080|H|   To prevent shortness of breath brought on by exercise, use the||
1222|081|H|inhaler before exercise as directed. Ask your doctor how soon you||
1222|082|H|can take the next dose of formoterol.||
1222|083|H|   Learn which of your inhalers you should use every day||
1222|084|H|(controller drugs) and which you should use if your breathing||
1222|085|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
1222|086|H|time what you should do if you have new or worsening cough or||
1222|087|H|shortness of breath, wheezing, increased sputum, worsening peak||
1222|088|H|flow meter readings, waking up at night with trouble breathing,||
1222|089|H|if you use your quick-relief inhaler more often (more than 2 days||
1222|090|H|a week), or if your quick-relief inhaler does not seem to be||
1222|091|H|working well. Learn when you can treat sudden breathing problems||
1222|092|H|by yourself and when you must get medical help right away.||
1222|093|H|   Contact your doctor promptly if your usual dose of formoterol||
1222|094|H|stops working well or if the effects of 1 dose of formoterol last||
1222|095|H|less than 12 hours. These situations can also be signs of||
1222|096|H|worsening asthma. If this occurs, do not increase your dose||
1222|097|H|without your doctor's approval or use this medication more often||
1222|098|H|than prescribed. Using too much formoterol can lead to serious||
1222|099|H|side effects.||
1222|100|B|||
1222|101|S|SIDE EFFECTS:  Shaking (tremor), fast/pounding heartbeat, or||
1222|102|S|headache may occur as your body adjusts to this medication. If||
1222|103|S|any of these effects last or get worse, tell your doctor or||
1222|104|S|pharmacist promptly.||
1222|105|S|   Remember that this medication has been prescribed because your||
1222|106|S|doctor has judged that the benefit to you is greater than the||
1222|107|S|risk of side effects. Many people using this medication do not||
1222|108|S|have serious side effects.||
1222|109|S|   This medication may raise your blood pressure. Check your||
1222|110|S|blood pressure regularly and tell your doctor if the results are||
1222|111|S|high.||
1222|112|S|   Tell your doctor right away if you have any serious side||
1222|113|S|effects, including: muscle weakness/cramps, increased||
1222|114|S|thirst/urination.||
1222|115|S|   Get medical help right away if you have any very serious side||
1222|116|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1222|117|S|dizziness, fainting.||
1222|118|S|   Rarely, this medication has caused severe (possibly fatal),||
1222|119|S|sudden worsening of breathing problems (paradoxical||
1222|120|S|bronchospasm). If you have trouble breathing or experience sudden||
1222|121|S|wheezing, use your quick-relief inhaler and get medical help||
1222|122|S|right away.||
1222|123|S|   A very serious allergic reaction to this drug is rare.||
1222|124|S|However, get medical help right away if you notice any symptoms||
1222|125|S|of a serious allergic reaction, including: rash, itching/swelling||
1222|126|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1222|127|S|breathing.||
1222|128|S|   This is not a complete list of possible side effects. If you||
1222|129|S|notice other effects not listed above, contact your doctor or||
1222|130|S|pharmacist.||
1222|131|S|   In the US -||
1222|132|S|   Call your doctor for medical advice about side effects. You||
1222|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1222|134|S|www.fda.gov/medwatch.||
1222|135|S|   In Canada - Call your doctor for medical advice about side||
1222|136|S|effects. You may report side effects to Health Canada at||
1222|137|S|1-866-234-2345.||
1222|138|B|||
1222|139|P|PRECAUTIONS:  Before using formoterol, tell your doctor or||
1222|140|P|pharmacist if you are allergic to it; or to arformoterol; or if||
1222|141|P|you have any other allergies. This product may contain inactive||
1222|142|P|ingredients (such as lactose, milk proteins), which can cause||
1222|143|P|allergic reactions or other problems. Talk to your pharmacist for||
1222|144|P|more details.||
1222|145|P|   Before using this medication, tell your doctor or pharmacist||
1222|146|P|your medical history, especially of: heart problems (such as||
1222|147|P|irregular heartbeat, angina), high blood pressure, overactive||
1222|148|P|thyroid, seizures, diabetes, swelling of an artery (aneurysm), a||
1222|149|P|certain adrenal gland tumor (pheochromocytoma).||
1222|150|P|   Formoterol may cause a condition that affects the heart rhythm||
1222|151|P|(QT prolongation). QT prolongation can rarely cause serious||
1222|152|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1222|153|P|as severe dizziness, fainting) that need medical attention right||
1222|154|P|away.||
1222|155|P|   The risk of QT prolongation may be increased if you have||
1222|156|P|certain medical conditions or are taking other drugs that may||
1222|157|P|cause QT prolongation. Before using formoterol, tell your doctor||
1222|158|P|or pharmacist of all the drugs you take and if you have any of||
1222|159|P|the following conditions: certain heart problems (heart failure,||
1222|160|P|slow heartbeat, QT prolongation in the EKG), family history of||
1222|161|P|certain heart problems (QT prolongation in the EKG, sudden||
1222|162|P|cardiac death).||
1222|163|P|   Low levels of potassium or magnesium in the blood may also||
1222|164|P|increase your risk of QT prolongation. This risk may increase if||
1222|165|P|you use certain drugs (such as diuretics/"water pills") or if you||
1222|166|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1222|167|P|Talk to your doctor about using formoterol safely.||
1222|168|P|   Before having surgery, tell your doctor or dentist about all||
1222|169|P|the products you use (including prescription drugs,||
1222|170|P|nonprescription drugs, and herbal products).||
1222|171|P|   Older adults may be more sensitive to the side effects of this||
1222|172|P|drug, especially QT prolongation (see above).||
1222|173|P|   During pregnancy, this medication should be used only when||
1222|174|P|clearly needed. Discuss the risks and benefits with your doctor.||
1222|175|P|   It is unknown if this drug passes into breast milk. Consult||
1222|176|P|your doctor before breastfeeding.||
1222|177|B|||
1222|178|I|DRUG INTERACTIONS:  See also Uses section.||
1222|179|I|   Drug interactions may change how your medications work or||
1222|180|I|increase your risk for serious side effects. This document does||
1222|181|I|not contain all possible drug interactions. Keep a list of all||
1222|182|I|the products you use (including prescription/nonprescription||
1222|183|I|drugs and herbal products) and share it with your doctor and||
1222|184|I|pharmacist. Do not start, stop, or change the dosage of any||
1222|185|I|medicines without your doctor's approval.||
1222|186|B|||
1222|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1222|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1222|189|O|poison control center right away. US residents can call||
1222|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1222|191|O|Symptoms of overdose may include: fast/irregular heartbeat,||
1222|192|O|severe dizziness, fainting.||
1222|193|B|||
1222|194|N|NOTES:  Do not share this medication with others.||
1222|195|N|   Lab and/or medical tests (such as lung function, blood||
1222|196|N|pressure, heart rate) should be done while you are using this||
1222|197|N|medication. Keep all medical and lab appointments. Consult your||
1222|198|N|doctor for more details.||
1222|199|N|   Learn to use a peak flow meter, use it daily, and promptly||
1222|200|N|report breathing problems (such as readings in the yellow/red||
1222|201|N|range, increased use of quick-relief inhalers).||
1222|202|N|   Avoid substances that can worsen breathing problems by causing||
1222|203|N|irritation or allergic reactions, such as smoke, pollen, pet||
1222|204|N|dander, dust, and mold.||
1222|205|N|   Because the flu virus can worsen breathing problems, ask your||
1222|206|N|doctor or pharmacist if you should have a flu shot every year.||
1222|207|B|||
1222|208|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1222|209|D|If it is more than 6 hours after the missed dose, skip the missed||
1222|210|D|dose. Use your next dose at the regular time. Do not double the||
1222|211|D|dose to catch up.||
1222|212|B|||
1222|213|R|STORAGE:  Store at room temperature. Store with the mouthpiece||
1222|214|R|cover on. Keep all medications away from children and pets.||
1222|215|R|   Do not flush medications down the toilet or pour them into a||
1222|216|R|drain unless instructed to do so. Properly discard this product||
1222|217|R|when it is expired or no longer needed. Consult your pharmacist||
1222|218|R|or local waste disposal company.||
1222|219|B|||
1222|220|M|MEDICAL ALERT:  Your condition can cause complications in a||
1222|221|M|medical emergency. For information about enrolling in MedicAlert,||
1222|222|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1222|223|B|||
1222|224|A|Information last revised March 2025.||
1222|225|A|Copyright(c) 2025 First Databank, Inc.||
1222|226|B|||
1223|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1223|002|Z|does NOT have all possible information about this product. This||
1223|003|Z|information does not assure that this product is safe, effective,||
1223|004|Z|or appropriate for you. This information is not individual||
1223|005|Z|medical advice and does not substitute for the advice of your||
1223|006|Z|health care professional. Always ask your health care||
1223|007|Z|professional for complete information about this product and your||
1223|008|Z|specific health needs.||
1223|009|B|||
1223|010|T|AZITHROMYCIN - INTRAVENOUS||
1223|011|F|(ay-ZITH-roe-MYE-sin)||
1223|012|B|||
1223|013|C|COMMON BRAND NAME(S): Zithromax||
1223|014|B|||
1223|015|U|USES:  This medication is an antibiotic used to treat certain||
1223|016|U|bacterial infections. This medication is known as a macrolide||
1223|017|U|(erythromycin-type) antibiotic. It works by stopping the growth||
1223|018|U|of bacteria. This medication is used to treat lung infections||
1223|019|U|(pneumonia) or female pelvic infections (such as PID) caused by||
1223|020|U|bacteria.||
1223|021|B|||
1223|022|V|OTHER USES:  This section contains uses of this drug that are not||
1223|023|V|listed in the approved professional labeling for the drug but||
1223|024|V|that may be prescribed by your health care professional. Use this||
1223|025|V|drug for a condition that is listed in this section only if it||
1223|026|V|has been so prescribed by your health care professional.||
1223|027|V|   This drug may also be used for other types of bacterial||
1223|028|V|infections.||
1223|029|B|||
1223|030|H|HOW TO USE:  This medication is usually given by injection into a||
1223|031|H|vein as directed by your doctor, usually once daily. It should be||
1223|032|H|injected slowly over 1 hour.||
1223|033|H|   If you are giving this medication to yourself at home, learn||
1223|034|H|all preparation and usage instructions from your health care||
1223|035|H|professional. Before using, check this product for particles or||
1223|036|H|discoloration. If either is present, do not use the liquid. Learn||
1223|037|H|how to store and discard medical supplies safely.||
1223|038|H|   You should use this injectable medication only until you are||
1223|039|H|able to take an antibiotic by mouth or until your treatment is||
1223|040|H|finished. The dosage and length of treatment are based on your||
1223|041|H|medical condition and response to treatment.||
1223|042|H|   For the best effect, use this antibiotic at evenly spaced||
1223|043|H|times. To help you remember, use this medication at the same||
1223|044|H|time(s) every day.||
1223|045|H|   Continue to use this medication until the full prescribed||
1223|046|H|amount is finished, even if symptoms disappear after a few days.||
1223|047|H|Stopping the medication too early may result in a return of the||
1223|048|H|infection.||
1223|049|H|   Tell your doctor if your condition lasts or gets worse.||
1223|050|B|||
1223|051|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea/loose stools, stomach||
1223|052|S|pain, or pain/redness at the injection site may occur. If any of||
1223|053|S|these effects last or get worse, tell your doctor or pharmacist||
1223|054|S|promptly.||
1223|055|S|   Remember that this medication has been prescribed because your||
1223|056|S|doctor has judged that the benefit to you is greater than the||
1223|057|S|risk of side effects. Many people using this medication do not||
1223|058|S|have serious side effects.||
1223|059|S|   Tell your doctor right away if you have any serious side||
1223|060|S|effects, including: hearing changes (such as ringing in the ears,||
1223|061|S|hearing loss), swelling legs/feet, eye problems (such as drooping||
1223|062|S|eyelids, blurred vision), trouble speaking, muscle weakness,||
1223|063|S|signs of liver problems (such as nausea/vomiting that doesn't||
1223|064|S|stop, unusual tiredness, severe stomach/abdominal pain, yellowing||
1223|065|S|eyes/skin, dark urine).||
1223|066|S|   Use of this medication for prolonged or repeated periods may||
1223|067|S|result in oral thrush or a new vaginal yeast infection. Contact||
1223|068|S|your doctor if you notice white patches/sores in your mouth, a||
1223|069|S|change in vaginal discharge, or other new symptoms.||
1223|070|S|   Get medical help right away if you have any very serious side||
1223|071|S|effects, including: severe dizziness, fainting, fast/irregular||
1223|072|S|heartbeat.||
1223|073|S|   This medication may rarely cause a severe intestinal condition||
1223|074|S|due to a bacteria called C. difficile. This condition may occur||
1223|075|S|during treatment or weeks to months after treatment has stopped.||
1223|076|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1223|077|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1223|078|S|stool.||
1223|079|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1223|080|S|products because they may make symptoms worse.||
1223|081|S|   A very serious allergic reaction to this drug is rare.||
1223|082|S|However, get medical help right away if you notice any symptoms||
1223|083|S|of a serious allergic reaction, including: fever that doesn't go||
1223|084|S|away, new or worsening lymph node swelling, rash,||
1223|085|S|itching/swelling (especially of the face/tongue/throat), severe||
1223|086|S|dizziness, trouble breathing.||
1223|087|S|   An allergic reaction to this medication may return even if you||
1223|088|S|stop the drug. If you have an allergic reaction, continue to||
1223|089|S|watch for any of the above symptoms for several days after your||
1223|090|S|last dose.||
1223|091|S|   This is not a complete list of possible side effects. If you||
1223|092|S|notice other effects not listed above, contact your doctor or||
1223|093|S|pharmacist.||
1223|094|S|   In the US -||
1223|095|S|   Call your doctor for medical advice about side effects. You||
1223|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1223|097|S|www.fda.gov/medwatch.||
1223|098|S|   In Canada - Call your doctor for medical advice about side||
1223|099|S|effects. You may report side effects to Health Canada at||
1223|100|S|1-866-234-2345.||
1223|101|B|||
1223|102|P|PRECAUTIONS:  Before using azithromycin, tell your doctor or||
1223|103|P|pharmacist if you are allergic to it; or to any other||
1223|104|P|macrolide/ketolide antibiotics (such as clarithromycin,||
1223|105|P|erythromycin); or if you have any other allergies. This product||
1223|106|P|may contain inactive ingredients, which can cause allergic||
1223|107|P|reactions or other problems. Talk to your pharmacist for more||
1223|108|P|details.||
1223|109|P|   Before using this medication, tell your doctor or pharmacist||
1223|110|P|your medical history, especially of: kidney disease, liver||
1223|111|P|disease, a certain muscle disease (myasthenia gravis).||
1223|112|P|   Azithromycin may cause a condition that affects the heart||
1223|113|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1223|114|P|serious (rarely fatal) fast/irregular heartbeat and other||
1223|115|P|symptoms (such as severe dizziness, fainting) that need medical||
1223|116|P|attention right away.||
1223|117|P|   The risk of QT prolongation may be increased if you have||
1223|118|P|certain medical conditions or are taking other drugs that may||
1223|119|P|cause QT prolongation. Before using azithromycin, tell your||
1223|120|P|doctor or pharmacist of all the drugs you take and if you have||
1223|121|P|any of the following conditions: certain heart problems (heart||
1223|122|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1223|123|P|history of certain heart problems (QT prolongation in the EKG,||
1223|124|P|sudden cardiac death).||
1223|125|P|   Low levels of potassium or magnesium in the blood may also||
1223|126|P|increase your risk of QT prolongation. This risk may increase if||
1223|127|P|you use certain drugs (such as diuretics/"water pills") or if you||
1223|128|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1223|129|P|Talk to your doctor about using azithromycin safely.||
1223|130|P|   This medication contains sodium. Consult your doctor for more||
1223|131|P|information if you are on a salt-restricted diet or if increased||
1223|132|P|salt intake could worsen your condition (such as heart failure).||
1223|133|P|   Azithromycin may cause live bacterial vaccines (such as||
1223|134|P|typhoid vaccine) to not work well. Tell your health care||
1223|135|P|professional that you are using azithromycin before having any||
1223|136|P|immunizations/vaccinations.||
1223|137|P|   Before having surgery, tell your doctor or dentist about all||
1223|138|P|the products you use (including prescription drugs,||
1223|139|P|nonprescription drugs, and herbal products).||
1223|140|P|   Older adults may be more sensitive to the side effects of this||
1223|141|P|drug, especially swelling legs/feet (due to sodium and water||
1223|142|P|retention) and QT prolongation (see above).||
1223|143|P|   Babies (especially younger than 6 weeks) may be at higher risk||
1223|144|P|for a certain serious stomach problem. Contact your child's||
1223|145|P|doctor right away if your child vomits or becomes irritable with||
1223|146|P|feeding.||
1223|147|P|   During pregnancy, this medication should be used only when||
1223|148|P|clearly needed. Discuss the risks and benefits with your doctor.||
1223|149|P|   This medication passes into breast milk. Consult your doctor||
1223|150|P|before breastfeeding.||
1223|151|B|||
1223|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1223|153|I|medications work or increase your risk for serious side effects.||
1223|154|I|This document does not contain all possible drug interactions.||
1223|155|I|Keep a list of all the products you use (including||
1223|156|I|prescription/nonprescription drugs and herbal products) and share||
1223|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
1223|158|I|the dosage of any medicines without your doctor's approval.||
1223|159|I|   This medication can slow down the removal of other medications||
1223|160|I|from your body, which may affect how they work. Examples of||
1223|161|I|affected drugs include colchicine, among others.||
1223|162|I|   Many drugs besides azithromycin may affect the heart rhythm||
1223|163|I|(QT prolongation), including amiodarone, chloroquine,||
1223|164|I|disopyramide, dofetilide, dronedarone, hydroxychloroquine,||
1223|165|I|ibutilide, pimozide, procainamide, quinidine, sotalol, among||
1223|166|I|others.||
1223|167|B|||
1223|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1223|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1223|170|O|poison control center right away. US residents can call||
1223|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1223|172|B|||
1223|173|N|NOTES:  Lab and/or medical tests may be done while you are using||
1223|174|N|this medication. Keep all medical and lab appointments. Consult||
1223|175|N|your doctor for more details.||
1223|176|B|||
1223|177|D|MISSED DOSE:  It is important to get each dose of this medication||
1223|178|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1223|179|D|right away for a new dosing schedule. Do not double the dose to||
1223|180|D|catch up.||
1223|181|B|||
1223|182|R|STORAGE:  Consult the product instructions and your pharmacist||
1223|183|R|for storage details. Keep all medications out of reach of||
1223|184|R|children and pets.||
1223|185|R|   Do not flush medications down the toilet or pour them into a||
1223|186|R|drain unless instructed to do so. Properly discard this product||
1223|187|R|when it is expired or no longer needed. Consult your pharmacist||
1223|188|R|or local waste disposal company.||
1223|189|B|||
1223|190|A|Information last revised December 2024.||
1223|191|A|Copyright(c) 2025 First Databank, Inc.||
1223|192|B|||
1224|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1224|002|Z|does NOT have all possible information about this product. This||
1224|003|Z|information does not assure that this product is safe, effective,||
1224|004|Z|or appropriate for you. This information is not individual||
1224|005|Z|medical advice and does not substitute for the advice of your||
1224|006|Z|health care professional. Always ask your health care||
1224|007|Z|professional for complete information about this product and your||
1224|008|Z|specific health needs.||
1224|009|B|||
1224|010|T|FLUPHENAZINE LIQUID - ORAL||
1224|011|F|(flew-FEN-uh-zeen)||
1224|012|B|||
1224|013|C|COMMON BRAND NAME(S): Prolixin||
1224|014|B|||
1224|015|W|WARNING:  There may be a slightly increased risk of serious,||
1224|016|W|possibly fatal side effects (such as heart failure,||
1224|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1224|018|W|by older adults with dementia. This medication is not approved||
1224|019|W|for the treatment of dementia-related behavior problems. Discuss||
1224|020|W|the risks and benefits of this medication, as well as other||
1224|021|W|effective and possibly safer treatments for dementia-related||
1224|022|W|behavior problems, with the doctor.||
1224|023|B|||
1224|024|U|USES:  This medication is used to treat certain mental/mood||
1224|025|U|disorders (such as schizophrenia). Fluphenazine belongs to a||
1224|026|U|class of drugs known as antipsychotics. It works by helping to||
1224|027|U|restore the balance of certain natural substances in the brain.||
1224|028|U|   This medication is not recommended for use in children under||
1224|029|U|12 years of age.||
1224|030|B|||
1224|031|H|HOW TO USE:  Take this medication by mouth with or without food||
1224|032|H|as directed by your doctor, usually 1 to 4 times daily. The||
1224|033|H|dosage is based on your age, medical condition, and response to||
1224|034|H|treatment.||
1224|035|H|   Before using, check this product for slight clouding or small||
1224|036|H|particles. If either is present, gently shake the liquid to||
1224|037|H|disperse the drug evenly. Do not use drug if, after shaking, it||
1224|038|H|has not cleared. Measure the dose carefully using a special||
1224|039|H|measuring device/spoon. Do not use a household spoon because you||
1224|040|H|may not get the correct dose. .||
1224|041|H|   Avoid getting the medication on your skin because allergic||
1224|042|H|reactions (contact dermatitis) may occur.||
1224|043|H|   Use this medication regularly to get the most benefit from it.||
1224|044|H|To help you remember, take it at the same time(s) each day.||
1224|045|H|   Do not stop taking this medication without consulting your||
1224|046|H|doctor. Some conditions may become worse when this drug is||
1224|047|H|suddenly stopped. Your dose may need to be gradually decreased.||
1224|048|H|   It may take up to two weeks for the full benefit of this||
1224|049|H|medication to take effect. Tell your doctor if your condition||
1224|050|H|does not get better or if it gets worse.||
1224|051|B|||
1224|052|S|SIDE EFFECTS:  Drowsiness, lethargy, dizziness, lightheadedness,||
1224|053|S|nausea, loss of appetite, sweating, dry mouth, blurred vision,||
1224|054|S|headache, and constipation may occur. If any of these effects||
1224|055|S|last or get worse, notify your doctor or pharmacist promptly.||
1224|056|S|   Dizziness and lightheadedness can increase the risk of||
1224|057|S|falling. Get up slowly when rising from a sitting or lying||
1224|058|S|position.||
1224|059|S|   Tell your doctor right away if any of these side effects||
1224|060|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
1224|061|S|mask-like expression of the face, drooling/trouble swallowing, or||
1224|062|S|shuffling walk. Your doctor may prescribe another medication to||
1224|063|S|decrease these side effects.||
1224|064|S|   Remember that this medication has been prescribed because your||
1224|065|S|doctor has judged that the benefit to you is greater than the||
1224|066|S|risk of side effects. Many people using this medication do not||
1224|067|S|have serious side effects.||
1224|068|S|   Tell your doctor right away if you have any serious side||
1224|069|S|effects, including: unusual mental/mood changes (such as||
1224|070|S|depression, confusion, worsening of psychosis), unusual dreams,||
1224|071|S|frequent urination or difficulty urinating, vision problems,||
1224|072|S|weight change, swelling of the feet/ankles, fainting, skin||
1224|073|S|discoloration, butterfly-shaped facial rash, joint pain,||
1224|074|S|seizures.||
1224|075|S|   In rare instances, this medication may increase your level of||
1224|076|S|a certain hormone (prolactin). For females, this rare increase in||
1224|077|S|prolactin may result in unwanted breast milk, missing/stopped||
1224|078|S|menstrual periods, or difficulty becoming pregnant. For males, it||
1224|079|S|may result in decreased sexual ability, inability to produce||
1224|080|S|sperm, or enlarged breasts. If you develop any of these symptoms,||
1224|081|S|tell your doctor right away.||
1224|082|S|   Rarely, males may have a painful or prolonged erection lasting||
1224|083|S|4 or more hours. If this occurs, stop using this drug and get||
1224|084|S|medical help right away, or permanent problems could occur.||
1224|085|S|   Fluphenazine may rarely cause a condition known as tardive||
1224|086|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1224|087|S|your doctor right away if you develop any unusual/uncontrolled||
1224|088|S|movements (especially of the face, mouth, tongue, arms, or legs).||
1224|089|S|   This medication may rarely cause a very serious condition||
1224|090|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1224|091|S|right away if you have any of the following symptoms: fever,||
1224|092|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1224|093|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1224|094|S|signs of kidney problems (such as change in the amount of urine).||
1224|095|S|   This drug may rarely cause serious blood problems (such as||
1224|096|S|agranulocytosis, leukopenia) or liver problems. Get medical help||
1224|097|S|right away if you notice any of the following rare but very||
1224|098|S|serious side effects: signs of infection (such as sore throat||
1224|099|S|that doesn't go away, fever, chills), easy bruising/bleeding,||
1224|100|S|severe stomach/abdominal pain, yellowing of the eyes/skin.||
1224|101|S|   A very serious allergic reaction to this drug is rare.||
1224|102|S|However, get medical help right away if you notice any symptoms||
1224|103|S|of a serious allergic reaction, including: rash, itching/swelling||
1224|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1224|105|S|breathing.||
1224|106|S|   This is not a complete list of possible side effects. If you||
1224|107|S|notice other effects not listed above, contact your doctor or||
1224|108|S|pharmacist.||
1224|109|S|   In the US -||
1224|110|S|   Call your doctor for medical advice about side effects. You||
1224|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1224|112|S|www.fda.gov/medwatch.||
1224|113|S|   In Canada - Call your doctor for medical advice about side||
1224|114|S|effects. You may report side effects to Health Canada at||
1224|115|S|1-866-234-2345.||
1224|116|B|||
1224|117|P|PRECAUTIONS:  Before taking fluphenazine, tell your doctor or||
1224|118|P|pharmacist if you are allergic to it; or to other phenothiazines||
1224|119|P|(such as chlorpromazine, perphenazine); or if you have any other||
1224|120|P|allergies. This product may contain inactive ingredients, which||
1224|121|P|can cause allergic reactions or other problems. Talk to your||
1224|122|P|pharmacist for more details.||
1224|123|P|   Before using this medication, tell your doctor or pharmacist||
1224|124|P|your medical history, especially of: brain damage, nervous system||
1224|125|P|problems (such as CNS depression, cerebrovascular insufficiency,||
1224|126|P|brain tumors, encephalitis, encephalopathy), blood problems (such||
1224|127|P|as leukopenia, thrombocytopenia, agranulocytosis), liver||
1224|128|P|problems, breast cancer, eye problems (such as glaucoma), heart||
1224|129|P|problems (such as very high or very low blood pressure, mitral||
1224|130|P|valve insufficiency), kidney problems, a certain adrenal gland||
1224|131|P|tumor (pheochromocytoma), seizures, exposure to phosphorus||
1224|132|P|insecticides, chronic breathing problems (such as asthma,||
1224|133|P|emphysema, frequent infections), low blood calcium, enlarged||
1224|134|P|prostate, drug or alcohol dependency, Reye's syndrome,||
1224|135|P|dehydration.||
1224|136|P|   Before having surgery or any diagnostic testing, tell your||
1224|137|P|doctor or dentist about all the products you use (including||
1224|138|P|prescription drugs, nonprescription drugs, and herbal products).||
1224|139|P|   This drug may make you dizzy or drowsy or blur your vision.||
1224|140|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1224|141|P|drowsy. Do not drive, use machinery, or do anything that needs||
1224|142|P|alertness or clear vision until you can do it safely. Avoid||
1224|143|P|alcoholic beverages. Talk to your doctor if you are using||
1224|144|P|marijuana (cannabis).||
1224|145|P|   This medication may make you more sensitive to the sun. Limit||
1224|146|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1224|147|P|sunscreen and wear protective clothing when outdoors. Tell your||
1224|148|P|doctor right away if you get sunburned or have skin||
1224|149|P|blisters/redness.||
1224|150|P|   This medication may make you sweat less, making you more||
1224|151|P|likely to get heat stroke. Avoid doing things that may cause you||
1224|152|P|to overheat, such as hard work or exercise in hot weather, or||
1224|153|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1224|154|P|and dress lightly. If you overheat, quickly look for a place to||
1224|155|P|cool down and rest. Get medical help right away if you have a||
1224|156|P|fever that does not go away, mental/mood changes, headache, or||
1224|157|P|dizziness.||
1224|158|P|   Avoid being exposed to very cold temperatures (such as||
1224|159|P|swimming in cold water). Severe lowering of your body temperature||
1224|160|P|may occur.||
1224|161|P|   Children may be more sensitive to the side effects of this||
1224|162|P|drug, especially the side effect of uncontrolled movements. This||
1224|163|P|is especially true if the child is sick (such as has chickenpox,||
1224|164|P|measles, stomach flu).||
1224|165|P|   Older adults may be more sensitive to the side effects of this||
1224|166|P|drug, especially to facial or muscle twitching, muscle||
1224|167|P|spasms/stiffness, uncontrolled movements (tardive dyskinesia),||
1224|168|P|drowsiness, dizziness, lightheadedness, confusion, and possible||
1224|169|P|effects on blood pressure. Drowsiness, dizziness,||
1224|170|P|lightheadedness, and confusion can increase the risk of falling.||
1224|171|P|   During pregnancy, this medication should be used only when||
1224|172|P|clearly needed. Liver problems or birth defects may occur in||
1224|173|P|infants exposed to this type of medication in the womb. Tell the||
1224|174|P|doctor right away if you notice yellowing of the eyes/skin or||
1224|175|P|dark urine in your infant. Babies born to mothers who have used||
1224|176|P|this drug during the last 3 months of pregnancy may rarely||
1224|177|P|develop symptoms including muscle stiffness or shakiness,||
1224|178|P|drowsiness, feeding/breathing difficulties, or constant crying.||
1224|179|P|If you notice any of these symptoms in your newborn especially||
1224|180|P|during their first month, tell the doctor right away.||
1224|181|P|   Since untreated mental/mood problems (such as schizophrenia)||
1224|182|P|can be a serious condition, do not stop taking this medication||
1224|183|P|unless directed by your doctor. If you are planning pregnancy,||
1224|184|P|become pregnant, or think you may be pregnant, immediately||
1224|185|P|discuss with your doctor the benefits and risks of using this||
1224|186|P|medication during pregnancy.||
1224|187|P|   It is unknown if this medication passes into breast milk.||
1224|188|P|However, similar drugs pass into breast milk. Consult your doctor||
1224|189|P|before breastfeeding.||
1224|190|B|||
1224|191|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1224|192|I|medications work or increase your risk for serious side effects.||
1224|193|I|This document does not contain all possible drug interactions.||
1224|194|I|Keep a list of all the products you use (including||
1224|195|I|prescription/nonprescription drugs and herbal products) and share||
1224|196|I|it with your doctor and pharmacist. Do not start, stop, or change||
1224|197|I|the dosage of any medicines without your doctor's approval.||
1224|198|I|   Some products that may interact with this drug are: guanadrel,||
1224|199|I|guanethidine, lithium.||
1224|200|I|   Tell your doctor or pharmacist if you are taking other||
1224|201|I|products that cause drowsiness such as opioid pain or cough||
1224|202|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1224|203|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1224|204|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1224|205|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1224|206|I|diphenhydramine).||
1224|207|I|   Check the labels on all your medicines (such as allergy or||
1224|208|I|cough-and-cold products) because they may contain ingredients||
1224|209|I|that cause drowsiness. Ask your pharmacist about using those||
1224|210|I|products safely.||
1224|211|I|   This medication may interfere with certain lab tests (such as||
1224|212|I|pregnancy test, phenylketonuria test, some urine tests), possibly||
1224|213|I|causing false test results. Make sure lab personnel and all your||
1224|214|I|doctors know you use this drug.||
1224|215|B|||
1224|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1224|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1224|218|O|poison control center right away. US residents can call||
1224|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1224|220|O|Symptoms of overdose may include: loss of consciousness,||
1224|221|O|seizures, fast/irregular heartbeat, or slow/shallow breathing.||
1224|222|B|||
1224|223|N|NOTES:  Do not share this medication with others.||
1224|224|N|   Lab and/or medical tests (such as liver/kidney function,||
1224|225|N|complete blood counts, eye exams, AIMS test) should be done while||
1224|226|N|you are taking this medication. Keep all medical and lab||
1224|227|N|appointments. Consult your doctor for more details.||
1224|228|B|||
1224|229|D|MISSED DOSE:  If you are taking this medication once daily and||
1224|230|D|you miss a dose, take it as soon as you remember. If it is near||
1224|231|D|the time of the next dose, skip the missed dose. Take your next||
1224|232|D|dose at the regular time. Do not double the dose to catch up.||
1224|233|D|   If you are taking this medication more than once daily and you||
1224|234|D|miss a dose, take it as soon as you remember. If it is more than||
1224|235|D|1 hour after the missed dose, skip the missed dose. Take your||
1224|236|D|next dose at the regular time. Do not double the dose to catch||
1224|237|D|up.||
1224|238|B|||
1224|239|R|STORAGE:  Store at room temperature away from light. Do not||
1224|240|R|freeze. Keep all medications away from children and pets.||
1224|241|R|   Do not flush medications down the toilet or pour them into a||
1224|242|R|drain unless instructed to do so. Properly discard this product||
1224|243|R|when it is expired or no longer needed. Consult your pharmacist||
1224|244|R|or local waste disposal company.||
1224|245|B|||
1224|246|A|Information last revised April 2025.||
1224|247|A|Copyright(c) 2025 First Databank, Inc.||
1224|248|B|||
1225|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1225|002|Z|does NOT have all possible information about this product. This||
1225|003|Z|information does not assure that this product is safe, effective,||
1225|004|Z|or appropriate for you. This information is not individual||
1225|005|Z|medical advice and does not substitute for the advice of your||
1225|006|Z|health care professional. Always ask your health care||
1225|007|Z|professional for complete information about this product and your||
1225|008|Z|specific health needs.||
1225|009|B|||
1225|010|T|DILTIAZEM SUSTAINED-ACTION - ORAL||
1225|011|F|(dill-TIE-uh-zem)||
1225|012|B|||
1225|013|C|COMMON BRAND NAME(S): Tiazac||
1225|014|B|||
1225|015|U|USES:  Diltiazem is used to treat high blood pressure||
1225|016|U|(hypertension) and prevent chest pain (angina). Lowering high||
1225|017|U|blood pressure helps prevent strokes, heart attacks, and kidney||
1225|018|U|problems. When used regularly, diltiazem can decrease the number||
1225|019|U|and severity of episodes of chest pain from angina. It may help||
1225|020|U|increase your ability to exercise.||
1225|021|U|   Diltiazem is called a calcium channel blocker. It works by||
1225|022|U|relaxing blood vessels in the body and heart so blood can flow||
1225|023|U|more easily. Diltiazem also lowers your heart rate. These effects||
1225|024|U|help the heart work less hard and lower blood pressure.||
1225|025|B|||
1225|026|V|OTHER USES:  This section contains uses of this drug that are not||
1225|027|V|listed in the approved professional labeling for the drug but||
1225|028|V|that may be prescribed by your health care professional. Use this||
1225|029|V|drug for a condition that is listed in this section only if it||
1225|030|V|has been so prescribed by your health care professional.||
1225|031|V|   Diltiazem may also be used to control your heart rate if you||
1225|032|V|have a fast/irregular heartbeat (such as atrial fibrillation).||
1225|033|B|||
1225|034|H|HOW TO USE:  Take this medication by mouth with or without food||
1225|035|H|as directed by your doctor, usually once daily. Swallow the||
1225|036|H|capsules whole. Do not crush or chew the capsules. Doing so can||
1225|037|H|release all of the drug at once and may increase your risk of||
1225|038|H|side effects.||
1225|039|H|   If you have trouble swallowing the capsule, you may open the||
1225|040|H|capsule and carefully sprinkle its contents on a spoonful of||
1225|041|H|soft, cool applesauce just before you take it. Swallow all of the||
1225|042|H|drug/food mixture right away. Do not chew the mixture. Then rinse||
1225|043|H|your mouth and swallow the rinse liquid to make sure that you||
1225|044|H|have swallowed all of the medicine. Do not prepare a supply in||
1225|045|H|advance.||
1225|046|H|   Your doctor may gradually increase your dose. Follow your||
1225|047|H|doctor's instructions carefully. The dosage is based on your||
1225|048|H|medical condition, response to treatment, and other medications||
1225|049|H|you may be taking. Be sure to tell your doctor and pharmacist||
1225|050|H|about all the products you use (including prescription drugs,||
1225|051|H|nonprescription drugs, and herbal products).||
1225|052|H|   Use this medication regularly to get the most benefit from it.||
1225|053|H|To help you remember, use it at the same time each day. Keep||
1225|054|H|taking this medication even if you feel well. Most people with||
1225|055|H|high blood pressure do not feel sick. For the treatment of high||
1225|056|H|blood pressure, it may take 2 to 4 weeks before you get the full||
1225|057|H|benefit of this drug.||
1225|058|H|   This medication must be taken regularly to prevent angina. It||
1225|059|H|should not be used to treat angina when it occurs. Use other||
1225|060|H|medications (such as nitroglycerin placed under the tongue) to||
1225|061|H|relieve an angina attack as directed by your doctor. Consult your||
1225|062|H|doctor or pharmacist for details.||
1225|063|H|   Tell your doctor if your condition does not get better or if||
1225|064|H|it gets worse (for example, your blood pressure readings remain||
1225|065|H|high or increase, your chest pain worsens).||
1225|066|B|||
1225|067|S|SIDE EFFECTS:  Dizziness, lightheadedness, weakness, nausea,||
1225|068|S|flushing, constipation, and headache may occur. If any of these||
1225|069|S|effects last or get worse, tell your doctor or pharmacist||
1225|070|S|promptly.||
1225|071|S|   To reduce the risk of dizziness and lightheadedness, get up||
1225|072|S|slowly when rising from a sitting or lying position.||
1225|073|S|   Remember that this medication has been prescribed because your||
1225|074|S|doctor has judged that the benefit to you is greater than the||
1225|075|S|risk of side effects. Many people using this medication do not||
1225|076|S|have serious side effects.||
1225|077|S|   Tell your doctor right away if you have any serious side||
1225|078|S|effects, including: nausea/vomiting that doesn't stop, fainting,||
1225|079|S|new or worsening symptoms of heart failure (such as shortness of||
1225|080|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
1225|081|S|weight gain), slow/irregular/pounding/fast heartbeat, mental/mood||
1225|082|S|changes (such as depression, agitation), unusual dreams, severe||
1225|083|S|stomach/abdominal pain, dark urine, yellowing eyes/skin.||
1225|084|S|   A very serious allergic reaction to this drug is rare.||
1225|085|S|However, get medical help right away if you notice any symptoms||
1225|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1225|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1225|088|S|breathing.||
1225|089|S|   This is not a complete list of possible side effects. If you||
1225|090|S|notice other effects not listed above, contact your doctor or||
1225|091|S|pharmacist.||
1225|092|S|   In the US -||
1225|093|S|   Call your doctor for medical advice about side effects. You||
1225|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1225|095|S|www.fda.gov/medwatch.||
1225|096|S|   In Canada - Call your doctor for medical advice about side||
1225|097|S|effects. You may report side effects to Health Canada at||
1225|098|S|1-866-234-2345.||
1225|099|B|||
1225|100|P|PRECAUTIONS:  Before taking diltiazem, tell your doctor or||
1225|101|P|pharmacist if you are allergic to it; or if you have any other||
1225|102|P|allergies. This product may contain inactive ingredients, which||
1225|103|P|can cause allergic reactions or other problems. Talk to your||
1225|104|P|pharmacist for more details.||
1225|105|P|   Before using this medication, tell your doctor or pharmacist||
1225|106|P|your medical history, especially of: certain types of heart||
1225|107|P|rhythm problems (such as sick sinus syndrome/atrioventricular||
1225|108|P|block), liver disease, kidney disease, heart failure.||
1225|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1225|110|P|can make you more dizzy. Do not drive, use machinery, or do||
1225|111|P|anything that needs alertness until you can do it safely. Limit||
1225|112|P|alcoholic beverages. Talk to your doctor if you are using||
1225|113|P|marijuana (cannabis).||
1225|114|P|   Before having surgery, tell your doctor or dentist about all||
1225|115|P|the products you use (including prescription drugs,||
1225|116|P|nonprescription drugs, and herbal products).||
1225|117|P|   Older adults may be more sensitive to the side effects of this||
1225|118|P|drug, especially dizziness, constipation, or swelling||
1225|119|P|ankles/feet.||
1225|120|P|   During pregnancy, this medication should be used only when||
1225|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
1225|122|P|   This drug passes into breast milk and may have undesirable||
1225|123|P|effects on a nursing infant. Consult your doctor before||
1225|124|P|breastfeeding.||
1225|125|B|||
1225|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1225|127|I|medications work or increase your risk for serious side effects.||
1225|128|I|This document does not contain all possible drug interactions.||
1225|129|I|Keep a list of all the products you use (including||
1225|130|I|prescription/nonprescription drugs and herbal products) and share||
1225|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
1225|132|I|the dosage of any medicines without your doctor's approval.||
1225|133|I|   Some products that may interact with this drug include:||
1225|134|I|digoxin, fingolimod, labetalol.||
1225|135|I|   Other medications can affect the removal of diltiazem from||
1225|136|I|your body, which may affect how this medication works. Examples||
1225|137|I|include azole antifungals (such as ketoconazole), cimetidine,||
1225|138|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
1225|139|I|rifabutin, rifampin), St. John's wort, among others.||
1225|140|I|   This medication can slow down the removal of other medications||
1225|141|I|from your body, which may affect how they work. Examples of||
1225|142|I|affected drugs include aprepitant/fosaprepitant, buspirone,||
1225|143|I|colchicine, elacestrant, flibanserin, ivabradine, lomitapide,||
1225|144|I|certain benzodiazepines (triazolam, midazolam), among others.||
1225|145|I|   Some products have ingredients that could raise your heart||
1225|146|I|rate or blood pressure. Tell your pharmacist what products you||
1225|147|I|are using, and ask how to use them safely (especially||
1225|148|I|cough-and-cold products, diet aids, or NSAIDs such as||
1225|149|I|ibuprofen/naproxen).||
1225|150|B|||
1225|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1225|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1225|153|O|poison control center right away. US residents can call||
1225|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1225|155|B|||
1225|156|N|NOTES:  Do not share this medication with others. Talk with your||
1225|157|N|doctor about making changes to your lifestyle that may help this||
1225|158|N|medication work better (such as stress reduction programs,||
1225|159|N|exercise, and dietary changes).||
1225|160|N|   Lab and/or medical tests (such as kidney/liver function,||
1225|161|N|pulse, blood pressure, EKG) may be done while you are taking this||
1225|162|N|medication. Keep all medical and lab appointments. Consult your||
1225|163|N|doctor for more details.||
1225|164|N|   There are different brands and types of this medication||
1225|165|N|available. Many do not have the same effects. Do not change||
1225|166|N|brands or types without consulting your doctor or pharmacist.||
1225|167|N|   Have your blood pressure and pulse (heart rate) checked||
1225|168|N|regularly while taking this medication. Learn how to check your||
1225|169|N|own blood pressure and pulse at home, and share the results with||
1225|170|N|your doctor.||
1225|171|B|||
1225|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1225|173|D|remember. If it is near the time of the next dose, skip the||
1225|174|D|missed dose. Take your next dose at the regular time. Do not||
1225|175|D|double the dose to catch up.||
1225|176|B|||
1225|177|R|STORAGE:  Store at room temperature away from light and moisture.||
1225|178|R|Do not store in the bathroom. Keep all medications away from||
1225|179|R|children and pets.||
1225|180|R|   Do not flush medications down the toilet or pour them into a||
1225|181|R|drain unless instructed to do so. Properly discard this product||
1225|182|R|when it is expired or no longer needed. Consult your pharmacist||
1225|183|R|or local waste disposal company.||
1225|184|B|||
1225|185|M|MEDICAL ALERT:  Your condition can cause complications in a||
1225|186|M|medical emergency. For information about enrolling in MedicAlert,||
1225|187|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1225|188|B|||
1225|189|A|Information last revised March 2025.||
1225|190|A|Copyright(c) 2025 First Databank, Inc.||
1225|191|B|||
1226|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1226|002|Z|does NOT have all possible information about this product. This||
1226|003|Z|information does not assure that this product is safe, effective,||
1226|004|Z|or appropriate for you. This information is not individual||
1226|005|Z|medical advice and does not substitute for the advice of your||
1226|006|Z|health care professional. Always ask your health care||
1226|007|Z|professional for complete information about this product and your||
1226|008|Z|specific health needs.||
1226|009|B|||
1226|010|T|FENOFIBRIC ACID - ORAL||
1226|011|F|(FEN-oh-FYE-brick AS-id)||
1226|012|B|||
1226|013|C|COMMON BRAND NAME(S): Fibricor||
1226|014|B|||
1226|015|U|USES:  Fenofibric acid is used along with a proper diet to help||
1226|016|U|lower "bad" cholesterol and fats (such as LDL, triglycerides) and||
1226|017|U|raise "good" cholesterol (HDL) in the blood. It works by||
1226|018|U|increasing the natural substance (enzyme) that breaks down fats||
1226|019|U|in the blood. Fenofibric acid belongs to a group of drugs known||
1226|020|U|as "fibrates." Lowering triglycerides in people with very high||
1226|021|U|triglyceride blood levels may decrease the risk of pancreas||
1226|022|U|disease (pancreatitis). However, fenofibric acid might not lower||
1226|023|U|your risk of a heart attack or stroke. Talk to your doctor about||
1226|024|U|the risks and benefits of fenofibric acid.||
1226|025|U|   In addition to eating a proper diet (such as a||
1226|026|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
1226|027|U|help this medication work better include exercising, losing||
1226|028|U|weight if overweight, and stopping smoking. Consult your doctor||
1226|029|U|for more details.||
1226|030|B|||
1226|031|H|HOW TO USE:  Take this medication by mouth with or without food||
1226|032|H|as directed by your doctor, usually once daily.||
1226|033|H|   The manufacturer directs not to crush or chew the tablet||
1226|034|H|before taking it. However, many similar drugs (immediate-release||
1226|035|H|tablets) can be crushed or chewed. Follow your doctor's||
1226|036|H|directions on how to take this medication.||
1226|037|H|   The dosage is based on your medical condition and response to||
1226|038|H|treatment.||
1226|039|H|   If you are also taking certain other drugs to lower your||
1226|040|H|cholesterol (bile acid-binding resins such as cholestyramine or||
1226|041|H|colestipol), take fenofibric acid at least 1 hour before or at||
1226|042|H|least 4 to 6 hours after taking these medications. These||
1226|043|H|medications can bind to fenofibric acid, preventing your body||
1226|044|H|from fully absorbing the drug.||
1226|045|H|   Take this medication regularly to get the most benefit from||
1226|046|H|it. To help you remember, take it at the same time each day. Do||
1226|047|H|not increase your dose or use this drug more often or for longer||
1226|048|H|than prescribed. Your cholesterol/triglycerides level will not||
1226|049|H|lower faster, and your risk of side effects will increase. Keep||
1226|050|H|taking this medication even if you feel well. Most people with||
1226|051|H|high cholesterol/triglycerides do not feel sick.||
1226|052|H|   It is very important to continue to follow your doctor's||
1226|053|H|advice about diet and exercise. It may take up to 2 months before||
1226|054|H|you get the full benefit of this medication.||
1226|055|B|||
1226|056|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1226|057|S|because your doctor has judged that the benefit to you is greater||
1226|058|S|than the risk of side effects. Many people using this medication||
1226|059|S|do not have serious side effects.||
1226|060|S|   This medication may rarely cause gallstones and liver||
1226|061|S|problems. If you notice any of the following unlikely but serious||
1226|062|S|side effects, tell your doctor right away: nausea/vomiting that||
1226|063|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
1226|064|S|eyes/skin, dark urine.||
1226|065|S|   This drug may rarely cause muscle problems (which can rarely||
1226|066|S|lead to a very serious condition called rhabdomyolysis). Tell||
1226|067|S|your doctor right away if you develop any of these symptoms:||
1226|068|S|muscle pain/tenderness/weakness (especially with fever or unusual||
1226|069|S|tiredness), signs of kidney problems (such as change in the||
1226|070|S|amount of urine).||
1226|071|S|   Rarely, this medication has caused severe lowering of HDL||
1226|072|S|("good" cholesterol) levels. This is the opposite of what should||
1226|073|S|happen to your HDL levels (paradoxical reaction). Your HDL||
1226|074|S|cholesterol levels should be checked regularly. Keep all of your||
1226|075|S|lab appointments.||
1226|076|S|   Tell your doctor right away if you have any serious side||
1226|077|S|effects, including: easy bleeding/bruising, unusual tiredness.||
1226|078|S|   Get medical help right away if you have any very serious side||
1226|079|S|effects, including: chest pain, sudden pain/redness/swelling||
1226|080|S|usually in the leg, signs of infection (such as sore throat that||
1226|081|S|doesn't go away, fever, swollen lymph nodes, chills).||
1226|082|S|   A very serious allergic reaction to this drug is rare.||
1226|083|S|However, get medical help right away if you notice any symptoms||
1226|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1226|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1226|086|S|breathing.||
1226|087|S|   This is not a complete list of possible side effects. If you||
1226|088|S|notice other effects not listed above, contact your doctor or||
1226|089|S|pharmacist.||
1226|090|S|   In the US -||
1226|091|S|   Call your doctor for medical advice about side effects. You||
1226|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1226|093|S|www.fda.gov/medwatch.||
1226|094|S|   In Canada - Call your doctor for medical advice about side||
1226|095|S|effects. You may report side effects to Health Canada at||
1226|096|S|1-866-234-2345.||
1226|097|B|||
1226|098|P|PRECAUTIONS:  Before taking fenofibric acid, tell your doctor or||
1226|099|P|pharmacist if you are allergic to it; or to other "fibrates"||
1226|100|P|(such as fenofibrate); or if you have any other allergies. This||
1226|101|P|product may contain inactive ingredients, which can cause||
1226|102|P|allergic reactions or other problems. Talk to your pharmacist for||
1226|103|P|more details.||
1226|104|P|   Before using this medication, tell your doctor or pharmacist||
1226|105|P|your medical history, especially of: kidney disease, liver||
1226|106|P|disease (such as biliary cholangitis, hepatitis), gallbladder||
1226|107|P|disease, alcohol use.||
1226|108|P|   Before having surgery, tell your doctor or dentist about all||
1226|109|P|the products you use (including prescription drugs,||
1226|110|P|nonprescription drugs, and herbal products).||
1226|111|P|   Older adults may be more sensitive to the side effects of this||
1226|112|P|drug, especially muscle problems.||
1226|113|P|   During pregnancy, this medication should be used only when||
1226|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
1226|115|P|   It is unknown if this medication passes into breast milk.||
1226|116|P|Because of the possible risk to the infant, breastfeeding is not||
1226|117|P|recommended while using this medication and for 5 days after the||
1226|118|P|last dose. Consult your doctor before breastfeeding.||
1226|119|B|||
1226|120|I|DRUG INTERACTIONS:  See also How to Use section.||
1226|121|I|   Drug interactions may change how your medications work or||
1226|122|I|increase your risk for serious side effects. This document does||
1226|123|I|not contain all possible drug interactions. Keep a list of all||
1226|124|I|the products you use (including prescription/nonprescription||
1226|125|I|drugs and herbal products) and share it with your doctor and||
1226|126|I|pharmacist. Do not start, stop, or change the dosage of any||
1226|127|I|medicines without your doctor's approval.||
1226|128|I|   Some products that may interact with this drug include: "blood||
1226|129|I|thinners" (such as warfarin).||
1226|130|I|   Fenofibric acid is very similar to fenofibrate. Do not use||
1226|131|I|medications containing fenofibrate while using fenofibric acid.||
1226|132|B|||
1226|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1226|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1226|135|O|poison control center right away. US residents can call||
1226|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1226|137|B|||
1226|138|N|NOTES:  Do not share this medication with others.||
1226|139|N|   Lab and/or medical tests (such as cholesterol/triglyceride||
1226|140|N|levels, kidney/liver function, complete blood count) should be||
1226|141|N|done while you are taking this medication. Keep all medical and||
1226|142|N|lab appointments. Consult your doctor for more details. (See also||
1226|143|N|Side Effects section.)||
1226|144|B|||
1226|145|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1226|146|D|next dose at the regular time. Do not double the dose to catch||
1226|147|D|up.||
1226|148|B|||
1226|149|R|STORAGE:  Store at room temperature away from light and moisture.||
1226|150|R|Do not store in the bathroom. Keep all medications away from||
1226|151|R|children and pets.||
1226|152|R|   Do not flush medications down the toilet or pour them into a||
1226|153|R|drain unless instructed to do so. Properly discard this product||
1226|154|R|when it is expired or no longer needed. Consult your pharmacist||
1226|155|R|or local waste disposal company.||
1226|156|B|||
1226|157|A|Information last revised June 2025.||
1226|158|A|Copyright(c) 2025 First Databank, Inc.||
1226|159|B|||
1228|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1228|002|Z|does NOT have all possible information about this product. This||
1228|003|Z|information does not assure that this product is safe, effective,||
1228|004|Z|or appropriate for you. This information is not individual||
1228|005|Z|medical advice and does not substitute for the advice of your||
1228|006|Z|health care professional. Always ask your health care||
1228|007|Z|professional for complete information about this product and your||
1228|008|Z|specific health needs.||
1228|009|B|||
1228|010|T|TIMOLOL/LATANOPROST - OPHTHALMIC||
1228|011|F|(TIM-oh-lol/la-TAN-oh-prost)||
1228|012|B|||
1228|013|U|USES:  This product contains 2 medications used to reduce high||
1228|014|U|pressure in the eye caused by glaucoma (open angle-type) or other||
1228|015|U|eye conditions (such as ocular hypertension). Lowering high||
1228|016|U|pressure inside the eye helps to prevent vision loss. Timolol||
1228|017|U|belongs to a class of drugs known as beta blockers. Latanoprost||
1228|018|U|belongs to a class of drugs known as prostaglandins.||
1228|019|B|||
1228|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1228|021|H|from your pharmacist before you start using this product and each||
1228|022|H|time you get a refill. If you have any questions, ask your doctor||
1228|023|H|or pharmacist.||
1228|024|H|   Use this medication in the affected eye(s) as directed by your||
1228|025|H|doctor, usually once daily.||
1228|026|H|   To apply eye drops, wash your hands first. To avoid||
1228|027|H|contamination, do not touch the dropper tip or let it touch your||
1228|028|H|eye or any other surface.||
1228|029|H|   The preservative in this product may be absorbed by contact||
1228|030|H|lenses. If you are wearing contact lenses, remove them before||
1228|031|H|using eye drops. Wait at least 15 minutes after using this||
1228|032|H|medication before replacing your contact lenses.||
1228|033|H|   Tilt your head back, look upward, and pull down the lower||
1228|034|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1228|035|H|and place one drop into the pouch. Look downward, gently close||
1228|036|H|your eyes, place one finger at the corner of your eye (near the||
1228|037|H|nose) and apply gentle pressure to prevent the medication from||
1228|038|H|draining out. Wait 2 to 3 minutes before opening your eyes. Try||
1228|039|H|not to blink and do not rub your eyes. Repeat these steps for||
1228|040|H|your other eye if so directed by your doctor.||
1228|041|H|   Do not rinse the dropper. Replace the dropper cap after each||
1228|042|H|use.||
1228|043|H|   If you are using another kind of eye medication (such as drops||
1228|044|H|or ointment), wait at least 5 minutes before applying other||
1228|045|H|medications. Use eye drops before eye ointments to allow the eye||
1228|046|H|drops to enter the eye.||
1228|047|H|   Wait several minutes for your vision to clear before driving||
1228|048|H|or operating machinery.||
1228|049|H|   Use this medication regularly in order to get the most benefit||
1228|050|H|from it. To help you remember, use it at the same time each day.||
1228|051|H|   Do not increase your dose or use this medication more often||
1228|052|H|than prescribed. Your condition will not improve any faster, and||
1228|053|H|your risk of side effects will increase.||
1228|054|H|   Keep using this medication even if you feel well. Most people||
1228|055|H|with glaucoma or high pressure in the eyes do not have symptoms.||
1228|056|B|||
1228|057|S|SIDE EFFECTS:  Temporary blurred vision, burning/itching/redness||
1228|058|S|in the eye, dry eyes, watery eyes, feeling as if something is in||
1228|059|S|the eye, increase in eyelash number/color/length/thickness,||
1228|060|S|eyelid changes/skin darkening, eyelid crusting/discomfort, or||
1228|061|S|headache may occur. If any of these effects last or get worse,||
1228|062|S|tell your doctor or pharmacist promptly.||
1228|063|S|   This medication may slowly (over months to years) cause brown||
1228|064|S|discoloration/darkening of the colored portion of the eye (iris).||
1228|065|S|If you are using this medication in only one eye, only that iris||
1228|066|S|may change color. This color change may be permanent and the||
1228|067|S|long-term effects are uncertain. Tell your doctor if this occurs||
1228|068|S|and schedule regular eye exams to monitor it.||
1228|069|S|   Remember that this medication has been prescribed because your||
1228|070|S|doctor has judged that the benefit to you is greater than the||
1228|071|S|risk of side effects. Many people using this medication do not||
1228|072|S|have serious side effects.||
1228|073|S|   Tell your doctor right away if you have any serious side||
1228|074|S|effects, including: eye pain/discomfort in bright light||
1228|075|S|(photophobia), slow/irregular heartbeat, signs of low blood||
1228|076|S|pressure (such as dizziness/fainting), mental/mood changes (such||
1228|077|S|as depression), coldness/numbness/pain in the hands or feet.||
1228|078|S|   Get medical help right away if you have any very serious side||
1228|079|S|effects, including: sudden vision change, trouble breathing,||
1228|080|S|signs of new/worsening heart failure (such as shortness of||
1228|081|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
1228|082|S|weight gain), symptoms of a heart attack (such as chest/jaw/left||
1228|083|S|arm pain, unusual sweating), signs of a stroke (such as weakness||
1228|084|S|on one side of the body, trouble speaking, confusion).||
1228|085|S|   A very serious allergic reaction to these drugs is rare.||
1228|086|S|However, get medical help right away if you notice any symptoms||
1228|087|S|of a serious allergic reaction, including: rash, severe||
1228|088|S|itching/swelling (especially of the face/tongue/throat), severe||
1228|089|S|dizziness, trouble breathing.||
1228|090|S|   This is not a complete list of possible side effects. If you||
1228|091|S|notice other effects not listed above, contact your doctor or||
1228|092|S|pharmacist.||
1228|093|S|   In the US -||
1228|094|S|   Call your doctor for medical advice about side effects. You||
1228|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1228|096|S|www.fda.gov/medwatch.||
1228|097|S|   In Canada - Call your doctor for medical advice about side||
1228|098|S|effects. You may report side effects to Health Canada at||
1228|099|S|1-866-234-2345.||
1228|100|B|||
1228|101|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1228|102|P|pharmacist if you are allergic to timolol or latanoprost; or if||
1228|103|P|you have any other allergies. This product may contain inactive||
1228|104|P|ingredients (such as preservatives like benzalkonium chloride),||
1228|105|P|which can cause allergic reactions or other problems. Talk to||
1228|106|P|your pharmacist for more details.||
1228|107|P|   Before using this medication, tell your doctor or pharmacist||
1228|108|P|your medical history, especially of: other eye problems (such as||
1228|109|P|iritis, uveitis, macular edema, lens extraction/aphakia, herpes||
1228|110|P|infection of the eye), lung disease/breathing problems (such as||
1228|111|P|current or past medical history of asthma, chronic obstructive||
1228|112|P|pulmonary disease), slow/irregular heartbeat, heart problems||
1228|113|P|(such as chest pain, heart failure), low blood pressure,||
1228|114|P|diabetes, blood circulation problems, overactive thyroid disease||
1228|115|P|(hyperthyroidism), a certain muscle/nerve disease (myasthenia||
1228|116|P|gravis), severe allergic reactions (such as anaphylaxis, atopy).||
1228|117|P|   If you develop an eye infection or injury, or have eye||
1228|118|P|surgery, check with your doctor about whether you should continue||
1228|119|P|to use your current bottle of timolol/latanoprost. You may be||
1228|120|P|advised to start using a new bottle.||
1228|121|P|   Before having surgery, tell your doctor or dentist about all||
1228|122|P|the products you use (including prescription drugs,||
1228|123|P|nonprescription drugs, and herbal products).||
1228|124|P|   After you apply this drug, your vision may become temporarily||
1228|125|P|blurred. Do not drive, use machinery, or do anything that needs||
1228|126|P|clear vision until you can do it safely.||
1228|127|P|   If you have diabetes, this product may prevent the||
1228|128|P|fast/pounding heartbeat you would usually feel when your blood||
1228|129|P|sugar level falls too low (hypoglycemia). Other symptoms of low||
1228|130|P|blood sugar, such as dizziness and sweating, are unaffected by||
1228|131|P|this drug.||
1228|132|P|   During pregnancy, this medication should be used only when||
1228|133|P|clearly needed. Discuss the risks and benefits with your doctor.||
1228|134|P|   Timolol passes into breast milk. It is unknown if latanoprost||
1228|135|P|passes into breast milk. Consult your doctor before||
1228|136|P|breastfeeding.||
1228|137|B|||
1228|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1228|139|I|medications work or increase your risk for serious side effects.||
1228|140|I|This document does not contain all possible drug interactions.||
1228|141|I|Keep a list of all the products you use (including||
1228|142|I|prescription/nonprescription drugs and herbal products) and share||
1228|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
1228|144|I|the dosage of any medicines without your doctor's approval.||
1228|145|I|   Some products that may interact with this drug include: beta||
1228|146|I|blockers (such as atenolol, propranolol), eyelash treatment (such||
1228|147|I|as bimatoprost), epinephrine.||
1228|148|B|||
1228|149|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1228|150|O|has overdosed and has serious symptoms such as passing out or||
1228|151|O|trouble breathing, call 911. Otherwise, call a poison control||
1228|152|O|center right away. US residents can call 1-800-222-1222. Canada||
1228|153|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1228|154|O|include: trouble breathing, slow/irregular heartbeat.||
1228|155|B|||
1228|156|N|NOTES:  Do not share this medication with others.||
1228|157|N|   Lab and/or medical tests (such as eye exams, heart rate)||
1228|158|N|should be done while you are using this medication. Keep all||
1228|159|N|medical and lab appointments. Consult your doctor for more||
1228|160|N|details.||
1228|161|B|||
1228|162|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
1228|163|D|if it is on the same day. If you do not remember until the next||
1228|164|D|day, skip the missed dose. Use your next dose at the regular||
1228|165|D|time. Do not double the dose to catch up.||
1228|166|B|||
1228|167|R|STORAGE:  Store the unopened bottle in the refrigerator away from||
1228|168|R|light. The opened bottle may be stored at room temperature away||
1228|169|R|from light. Once the bottle is opened, this medication expires||
1228|170|R|after 10 weeks. Keep all medications away from children and pets.||
1228|171|R|   Do not flush medications down the toilet or pour them into a||
1228|172|R|drain unless instructed to do so. Properly discard this product||
1228|173|R|when it is expired or no longer needed. Consult your pharmacist||
1228|174|R|or local waste disposal company.||
1228|175|B|||
1228|176|A|Information last revised September 2024.||
1228|177|A|Copyright(c) 2025 First Databank, Inc.||
1228|178|B|||
1230|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1230|002|Z|does NOT have all possible information about this product. This||
1230|003|Z|information does not assure that this product is safe, effective,||
1230|004|Z|or appropriate for you. This information is not individual||
1230|005|Z|medical advice and does not substitute for the advice of your||
1230|006|Z|health care professional. Always ask your health care||
1230|007|Z|professional for complete information about this product and your||
1230|008|Z|specific health needs.||
1230|009|B|||
1230|010|T|ECALLANTIDE - INJECTION||
1230|011|F|(e-KAL-lan-tide)||
1230|012|B|||
1230|013|C|COMMON BRAND NAME(S): Kalbitor||
1230|014|B|||
1230|015|W|WARNING:  Ecallantide may rarely cause serious (rarely fatal)||
1230|016|W|allergic reactions. Patients who experience a severe allergic||
1230|017|W|reaction with this drug must never use it again. Because the||
1230|018|W|symptoms can be the same for an allergic reaction and the||
1230|019|W|condition which this medication treats, you will be monitored||
1230|020|W|closely by your healthcare providers as you receive this||
1230|021|W|medication in a clinic or hospital. Get medical help right away||
1230|022|W|if you develop any signs of an allergic reaction such as rash,||
1230|023|W|itching/swelling (especially of the face/tongue/throat), severe||
1230|024|W|dizziness, trouble breathing, or chest pain.||
1230|025|B|||
1230|026|U|USES:  This medication is used to treat an acute attack of a||
1230|027|U|certain immune disease passed down through families (hereditary||
1230|028|U|angioedema-HAE). Ecallantide blocks a natural substance produced||
1230|029|U|by the body (kallikrein) which acts to increase amounts of||
1230|030|U|another natural substance (bradykinin) thought to cause the||
1230|031|U|symptoms seen during an acute attack of HAE. This medication does||
1230|032|U|not cure HAE. Ecallantide may lessen the symptoms during an acute||
1230|033|U|attack of HAE such as rapid swelling and pain of the hands, feet,||
1230|034|U|limbs, face, tongue, or throat. When attacks involve the||
1230|035|U|intestines, symptoms may include abdominal pain/cramps, diarrhea||
1230|036|U|or vomiting. Attacks of swelling may occur without reason.||
1230|037|U|However, anxiety, stress, sickness, and surgery may trigger||
1230|038|U|attacks in some people.||
1230|039|B|||
1230|040|H|HOW TO USE:  Read the Medication Guide provided by your||
1230|041|H|pharmacist before you start using ecallantide and each time you||
1230|042|H|get a refill. If you have any questions, ask your doctor or||
1230|043|H|pharmacist.||
1230|044|H|   This medication is given by injection under the skin by a||
1230|045|H|healthcare professional. It is given as directed by your doctor,||
1230|046|H|usually as three separate shots which are spaced by at least 2||
1230|047|H|inches (5 centimeters) apart. An additional three shots may be||
1230|048|H|given in a 24-hour period if the HAE attack continues. The||
1230|049|H|injection is given in the abdomen, thigh, or upper arms. The||
1230|050|H|medication should not be injected into skin that is tender, red,||
1230|051|H|or hard.||
1230|052|H|   Tell your doctor if your condition does not get better or if||
1230|053|H|it gets worse.||
1230|054|B|||
1230|055|S|SIDE EFFECTS:  See also Warning section.||
1230|056|S|   Bruising, itching, redness, swelling of the skin at the||
1230|057|S|injection site may occur. Nausea, fever, or stuffy nose may also||
1230|058|S|occur. If any of these effects last or get worse, tell your||
1230|059|S|doctor or pharmacist promptly.||
1230|060|S|   Remember that this medication has been prescribed because your||
1230|061|S|doctor has judged that the benefit to you is greater than the||
1230|062|S|risk of side effects. Many people using this medication do not||
1230|063|S|have serious side effects.||
1230|064|S|   This is not a complete list of possible side effects. If you||
1230|065|S|notice other effects not listed above, contact your doctor or||
1230|066|S|pharmacist.||
1230|067|S|   In the US -||
1230|068|S|   Call your doctor for medical advice about side effects. You||
1230|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1230|070|S|www.fda.gov/medwatch.||
1230|071|S|   In Canada - Call your doctor for medical advice about side||
1230|072|S|effects. You may report side effects to Health Canada at||
1230|073|S|1-866-234-2345.||
1230|074|B|||
1230|075|P|PRECAUTIONS:  Before using ecallantide, tell your doctor or||
1230|076|P|pharmacist if you are allergic to it; or if you have any other||
1230|077|P|allergies. This product may contain inactive ingredients, which||
1230|078|P|can cause allergic reactions or other problems. Talk to your||
1230|079|P|pharmacist for more details.||
1230|080|P|   Before using this medication, tell your doctor or pharmacist||
1230|081|P|your medical history.||
1230|082|P|   Before having surgery, tell your doctor or dentist about all||
1230|083|P|the products you use (including prescription drugs,||
1230|084|P|nonprescription drugs, and herbal products).||
1230|085|P|   During pregnancy, this medication should be used only when||
1230|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
1230|087|P|   It is unknown if this drug passes into breast milk. Consult||
1230|088|P|your doctor before breastfeeding.||
1230|089|B|||
1230|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1230|091|I|medications work or increase your risk for serious side effects.||
1230|092|I|This document does not contain all possible drug interactions.||
1230|093|I|Keep a list of all the products you use (including||
1230|094|I|prescription/nonprescription drugs and herbal products) and share||
1230|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
1230|096|I|the dosage of any medicines without your doctor's approval.||
1230|097|B|||
1230|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1230|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1230|100|O|poison control center right away. US residents can call||
1230|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1230|102|B|||
1230|103|N|NOTES:  Keep all medical and lab appointments.||
1230|104|B|||
1230|105|D|MISSED DOSE:  Not applicable.||
1230|106|B|||
1230|107|R|STORAGE:  Not applicable. This medication is given in a clinic||
1230|108|R|and will not be stored at home.||
1230|109|B|||
1230|110|A|Information last revised October 2024.||
1230|111|A|Copyright(c) 2025 First Databank, Inc.||
1230|112|B|||
1231|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1231|002|Z|does NOT have all possible information about this product. This||
1231|003|Z|information does not assure that this product is safe, effective,||
1231|004|Z|or appropriate for you. This information is not individual||
1231|005|Z|medical advice and does not substitute for the advice of your||
1231|006|Z|health care professional. Always ask your health care||
1231|007|Z|professional for complete information about this product and your||
1231|008|Z|specific health needs.||
1231|009|B|||
1231|010|T|VEDOLIZUMAB - SUBCUTANEOUS INJECTION||
1231|011|F|(VE-doe-LIZ-ue-mab)||
1231|012|B|||
1231|013|C|COMMON BRAND NAME(S): Entyvio||
1231|014|B|||
1231|015|U|USES:  This medication is used to treat certain bowel disorders||
1231|016|U|(ulcerative colitis, Crohn's disease). In these conditions, the||
1231|017|U|body's defense system (immune system) attacks healthy tissues in||
1231|018|U|the gut, causing symptoms such as abdominal pain, blood in the||
1231|019|U|stool, and diarrhea. Vedolizumab belongs to a class of drugs||
1231|020|U|known as monoclonal antibodies. It works by blocking the actions||
1231|021|U|of a certain natural substance (integrin) in the body. This helps||
1231|022|U|to decrease swelling (inflammation) in the gut, which lessens||
1231|023|U|symptoms and may slow or stop damage from these bowel disorders.||
1231|024|B|||
1231|025|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1231|026|H|provided by your pharmacist before you start using vedolizumab||
1231|027|H|and each time you get a refill. Ask your health care professional||
1231|028|H|how to prepare and use this medication. If you have any||
1231|029|H|questions, ask your doctor or pharmacist.||
1231|030|H|   Inject this medication under the skin as directed by your||
1231|031|H|doctor, usually once every 2 weeks. The injection is given in the||
1231|032|H|thigh, upper arm, or abdomen (except for a 2-inch area around||
1231|033|H|your belly button).||
1231|034|H|   Take the medication out of the refrigerator at least 30||
1231|035|H|minutes before you inject it to allow it to reach room||
1231|036|H|temperature. Do not warm up this medication any other way (for||
1231|037|H|example, do not heat it in the microwave or leave it in direct||
1231|038|H|sunlight). Do not shake the medication. Before using, check this||
1231|039|H|product for particles or discoloration. If either is present, do||
1231|040|H|not use the liquid. Before injecting each dose, clean the skin||
1231|041|H|you are going to inject into (the injection site) with rubbing||
1231|042|H|alcohol. Change the injection site each time to lessen injury||
1231|043|H|under the skin. Do not inject into skin that is damaged, bruised,||
1231|044|H|tender, hardened, or red, or into scars or moles. To lessen||
1231|045|H|bruising, do not rub the injection site after a shot. Learn how||
1231|046|H|to store and discard medical supplies safely.||
1231|047|H|   Use this medication regularly to get the most benefit from it.||
1231|048|H|To help you remember, mark your calendar with a reminder.||
1231|049|H|   Tell your doctor if your condition does not get better or if||
1231|050|H|it gets worse.||
1231|051|B|||
1231|052|S|SIDE EFFECTS:  Swelling or mild rash/itching at injection site,||
1231|053|S|nausea, headache, flu/common cold symptoms, or tiredness may||
1231|054|S|occur. If any of these effects last or get worse, tell your||
1231|055|S|doctor or pharmacist promptly.||
1231|056|S|   Remember that this medication has been prescribed because your||
1231|057|S|doctor has judged that the benefit to you is greater than the||
1231|058|S|risk of side effects. Many people using this medication do not||
1231|059|S|have serious side effects.||
1231|060|S|   Tell your doctor right away if you have any serious side||
1231|061|S|effects, including: pain/numbness in your arms/legs, symptoms of||
1231|062|S|liver damage (such as nausea/vomiting that doesn't stop, loss of||
1231|063|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1231|064|S|urine).||
1231|065|S|   This medication may lower your ability to fight infections.||
1231|066|S|This may make you more likely to get a serious (rarely fatal)||
1231|067|S|infection or make any infection you have worse. Tell your doctor||
1231|068|S|right away if you have any signs of infection (such as sore||
1231|069|S|throat that doesn't go away, fever, chills).||
1231|070|S|   This medication may increase your risk of getting a rare but||
1231|071|S|very serious (possibly fatal) brain infection (progressive||
1231|072|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1231|073|S|if you have any of these side effects: clumsiness, loss of||
1231|074|S|coordination/balance, weakness, sudden change in your thinking||
1231|075|S|(such as confusion, difficulty concentrating, memory loss),||
1231|076|S|difficulty talking/walking, seizure, vision changes.||
1231|077|S|   A very serious allergic reaction to this drug is rare.||
1231|078|S|However, get medical help right away if you notice any symptoms||
1231|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1231|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1231|081|S|breathing.||
1231|082|S|   This is not a complete list of possible side effects. If you||
1231|083|S|notice other effects not listed above, contact your doctor or||
1231|084|S|pharmacist.||
1231|085|S|   In the US -||
1231|086|S|   Call your doctor for medical advice about side effects. You||
1231|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1231|088|S|www.fda.gov/medwatch.||
1231|089|S|   In Canada - Call your doctor for medical advice about side||
1231|090|S|effects. You may report side effects to Health Canada at||
1231|091|S|1-866-234-2345.||
1231|092|B|||
1231|093|P|PRECAUTIONS:  Before using vedolizumab, tell your doctor or||
1231|094|P|pharmacist if you are allergic to it; or if you have any other||
1231|095|P|allergies. This product may contain inactive ingredients, which||
1231|096|P|can cause allergic reactions or other problems. Talk to your||
1231|097|P|pharmacist for more details.||
1231|098|P|   Before using this medication, tell your doctor or pharmacist||
1231|099|P|your medical history, especially of: symptoms of infection (such||
1231|100|P|as fever, chills, sore throat, cough, runny nose),||
1231|101|P|current/past/returning infections (such as tuberculosis).||
1231|102|P|   Vedolizumab can make you more likely to get infections or may||
1231|103|P|make current infections worse. Stay away from anyone who has an||
1231|104|P|infection that may easily spread (such as chickenpox, COVID-19,||
1231|105|P|measles, flu). Talk to your doctor if you have been exposed to an||
1231|106|P|infection or for more details.||
1231|107|P|   Tell your doctor your vaccine history and ask if you need to||
1231|108|P|get any vaccines before starting treatment with this medication.||
1231|109|P|Tell your health care professional that you are using vedolizumab||
1231|110|P|before having any immunizations/vaccinations. Avoid contact with||
1231|111|P|people who have recently received live vaccines (such as flu||
1231|112|P|vaccine inhaled through the nose).||
1231|113|P|   Before having surgery, tell your doctor or dentist about all||
1231|114|P|the products you use (including prescription drugs,||
1231|115|P|nonprescription drugs, and herbal products).||
1231|116|P|   During pregnancy, this medication should be used only when||
1231|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
1231|118|P|Mothers who have used this medication during pregnancy should ask||
1231|119|P|a doctor about immunizations/vaccinations for their newborn||
1231|120|P|babies.||
1231|121|P|   This drug passes into breast milk. Consult your doctor before||
1231|122|P|breastfeeding.||
1231|123|B|||
1231|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1231|125|I|medications work or increase your risk for serious side effects.||
1231|126|I|This document does not contain all possible drug interactions.||
1231|127|I|Keep a list of all the products you use (including||
1231|128|I|prescription/nonprescription drugs and herbal products) and share||
1231|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
1231|130|I|the dosage of any medicines without your doctor's approval.||
1231|131|I|   Some products that may interact with this drug are: other||
1231|132|I|drugs that weaken the immune system/increase the risk of||
1231|133|I|infection (such as natalizumab, rituximab, TNF blockers such as||
1231|134|I|adalimumab/infliximab).||
1231|135|B|||
1231|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1231|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1231|138|O|poison control center right away. US residents can call||
1231|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1231|140|B|||
1231|141|N|NOTES:  Do not share this medication with others.||
1231|142|N|   Lab and/or medical tests (such as liver function) should be||
1231|143|N|done while you are using this medication. Keep all medical and||
1231|144|N|lab appointments. Consult your doctor for more details.||
1231|145|B|||
1231|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1231|147|D|Use your next dose at the regular time from when you remembered||
1231|148|D|to use your missed dose. Do not double the dose to catch up.||
1231|149|B|||
1231|150|R|STORAGE:  Store in the refrigerator. Do not freeze. Do not use||
1231|151|R|this medication if it has been frozen. Keep the medication in the||
1231|152|R|original carton to protect from light. This medication may also||
1231|153|R|be stored at room temperature if needed. If the medication is||
1231|154|R|stored at room temperature, discard after 7 days. Keep all||
1231|155|R|medications away from children and pets.||
1231|156|R|   Do not flush medications down the toilet or pour them into a||
1231|157|R|drain unless instructed to do so. Properly discard this product||
1231|158|R|when it is expired or no longer needed. Consult your pharmacist||
1231|159|R|or local waste disposal company.||
1231|160|B|||
1231|161|M|MEDICAL ALERT:  Your condition can cause complications in a||
1231|162|M|medical emergency. For information about enrolling in MedicAlert,||
1231|163|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1231|164|B|||
1231|165|A|Information last revised November 2025.||
1231|166|A|Copyright(c) 2025 First Databank, Inc.||
1231|167|B|||
1232|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1232|002|Z|does NOT have all possible information about this product. This||
1232|003|Z|information does not assure that this product is safe, effective,||
1232|004|Z|or appropriate for you. This information is not individual||
1232|005|Z|medical advice and does not substitute for the advice of your||
1232|006|Z|health care professional. Always ask your health care||
1232|007|Z|professional for complete information about this product and your||
1232|008|Z|specific health needs.||
1232|009|B|||
1232|010|T|EVINACUMAB - INJECTION||
1232|011|F|(E-vin-AK-ue-mab)||
1232|012|B|||
1232|013|C|COMMON BRAND NAME(S): Evkeeza||
1232|014|B|||
1232|015|U|USES:  Evinacumab is used to treat a certain high cholesterol||
1232|016|U|disorder (homozygous familial hypercholesterolemia-HoFH). It is||
1232|017|U|used along with a proper diet and other LDL-lowering treatments||
1232|018|U|(such as "statin" drugs, ezetimibe, LDL apheresis). Evinacumab||
1232|019|U|belongs to a class of drugs known as monoclonal antibodies. It||
1232|020|U|works by blocking a certain protein that stops your body from||
1232|021|U|properly breaking down cholesterol. This effect helps decrease||
1232|022|U|"bad cholesterol" and fats (such as LDL, triglycerides).||
1232|023|U|   In addition to eating a proper diet (such as a||
1232|024|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
1232|025|U|help this medication work better include exercising, losing||
1232|026|U|weight if overweight, and stopping smoking. Consult your doctor||
1232|027|U|for more details.||
1232|028|B|||
1232|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1232|030|H|from your pharmacist before you start using evinacumab and each||
1232|031|H|time you get a refill. If you have any questions, ask your doctor||
1232|032|H|or pharmacist.||
1232|033|H|   This medication is given by injection into a vein as directed||
1232|034|H|by your doctor, usually once every month (every 4 weeks). The||
1232|035|H|injection is given by a health care professional, usually over 60||
1232|036|H|minutes. The dosage is based on your medical condition, weight,||
1232|037|H|and response to treatment.||
1232|038|H|   Use this medication regularly to get the most benefit from it.||
1232|039|H|To help you remember, mark your calendar with a reminder.||
1232|040|B|||
1232|041|S|SIDE EFFECTS:  Itching, fever, muscle weakness, or nausea during||
1232|042|S|the injection may occur. Dizziness and runny/stuffy nose may also||
1232|043|S|occur. If any of these effects last or get worse, tell your||
1232|044|S|doctor or pharmacist promptly.||
1232|045|S|   Remember that this medication has been prescribed because your||
1232|046|S|doctor has judged that the benefit to you is greater than the||
1232|047|S|risk of side effects. Many people using this medication do not||
1232|048|S|have serious side effects.||
1232|049|S|   A very serious allergic reaction to this drug is rare.||
1232|050|S|However, get medical help right away if you notice any symptoms||
1232|051|S|of a serious allergic reaction, including: rash, itching/swelling||
1232|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1232|053|S|breathing.||
1232|054|S|   This is not a complete list of possible side effects. If you||
1232|055|S|notice other effects not listed above, contact your doctor or||
1232|056|S|pharmacist.||
1232|057|S|   In the US -||
1232|058|S|   Call your doctor for medical advice about side effects. You||
1232|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1232|060|S|www.fda.gov/medwatch.||
1232|061|S|   In Canada - Call your doctor for medical advice about side||
1232|062|S|effects. You may report side effects to Health Canada at||
1232|063|S|1-866-234-2345.||
1232|064|B|||
1232|065|P|PRECAUTIONS:  Before using evinacumab, tell your doctor or||
1232|066|P|pharmacist if you are allergic to it; or if you have any other||
1232|067|P|allergies. This product may contain inactive ingredients, which||
1232|068|P|can cause allergic reactions or other problems. Talk to your||
1232|069|P|pharmacist for more details.||
1232|070|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1232|071|P|can make you more dizzy. Do not drive, use machinery, or do||
1232|072|P|anything that needs alertness until you can do it safely. Limit||
1232|073|P|alcoholic beverages. Talk to your doctor if you are using||
1232|074|P|marijuana (cannabis).||
1232|075|P|   Before having surgery, tell your doctor or dentist about all||
1232|076|P|the products you use (including prescription drugs,||
1232|077|P|nonprescription drugs, and herbal products).||
1232|078|P|   Tell your doctor if you are pregnant or plan to become||
1232|079|P|pregnant. You should not become pregnant while using evinacumab.||
1232|080|P|Evinacumab may harm an unborn baby. Your doctor should order a||
1232|081|P|pregnancy test before you start this medication. Ask about||
1232|082|P|reliable forms of birth control while using this medication and||
1232|083|P|for at least 5 months after the last dose. If you become||
1232|084|P|pregnant, talk to your doctor right away about the risks and||
1232|085|P|benefits of this medication.||
1232|086|P|   It is unknown if this medication passes into breast milk.||
1232|087|P|Consult your doctor before breastfeeding.||
1232|088|B|||
1232|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1232|090|I|medications work or increase your risk for serious side effects.||
1232|091|I|This document does not contain all possible drug interactions.||
1232|092|I|Keep a list of all the products you use (including||
1232|093|I|prescription/nonprescription drugs and herbal products) and share||
1232|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
1232|095|I|the dosage of any medicines without your doctor's approval.||
1232|096|B|||
1232|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1232|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1232|099|O|poison control center right away. US residents can call||
1232|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1232|101|B|||
1232|102|N|NOTES:  Lab and/or medical tests (such as cholesterol tests)||
1232|103|N|should be done while you are using this medication. Keep all||
1232|104|N|medical and lab appointments.||
1232|105|B|||
1232|106|D|MISSED DOSE:  It is important to get each dose of this medication||
1232|107|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1232|108|D|right away for a new dosing schedule.||
1232|109|B|||
1232|110|R|STORAGE:  Not applicable. This medication is given in a hospital||
1232|111|R|or clinic or doctor's office and will not be stored at home.||
1232|112|B|||
1232|113|A|Information last revised October 2024.||
1232|114|A|Copyright(c) 2025 First Databank, Inc.||
1232|115|B|||
1233|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1233|002|Z|does NOT have all possible information about this product. This||
1233|003|Z|information does not assure that this product is safe, effective,||
1233|004|Z|or appropriate for you. This information is not individual||
1233|005|Z|medical advice and does not substitute for the advice of your||
1233|006|Z|health care professional. Always ask your health care||
1233|007|Z|professional for complete information about this product and your||
1233|008|Z|specific health needs.||
1233|009|B|||
1233|010|T|TRILACICLIB - INJECTION||
1233|011|F|(TRYE-la-SYE-klib)||
1233|012|B|||
1233|013|C|COMMON BRAND NAME(S): Cosela||
1233|014|B|||
1233|015|U|USES:  This medication is used to reduce the risk of blood/bone||
1233|016|U|marrow problems (such as low red/white blood cells and platelets)||
1233|017|U|caused by certain cancer drug treatment (chemotherapy).||
1233|018|U|Trilaciclib helps to increase the number of blood cells such as||
1233|019|U|red cells, white cells, and platelets. This effect may reduce the||
1233|020|U|need for blood transfusions and increase your body's ability to||
1233|021|U|fight an infection.||
1233|022|B|||
1233|023|H|HOW TO USE:  This medication is given by injection into a vein||
1233|024|H|over 30 minutes as directed by your doctor. It is usually given||
1233|025|H|within 4 hours before the start of chemotherapy.||
1233|026|H|   Use this medication regularly to get the most benefit from it.||
1233|027|H|To help you remember, mark your calendar with a reminder.||
1233|028|B|||
1233|029|S|SIDE EFFECTS:  Redness, pain, or swelling at the injection site||
1233|030|S|may occur. If any of these effects last or get worse, tell your||
1233|031|S|doctor or pharmacist promptly.||
1233|032|S|   Remember that this medication has been prescribed because your||
1233|033|S|doctor has judged that the benefit to you is greater than the||
1233|034|S|risk of side effects. Many people using this medication do not||
1233|035|S|have serious side effects.||
1233|036|S|   Tell your doctor right away if you have any serious side||
1233|037|S|effects, including: pain and swelling in a vein,||
1233|038|S|pain/redness/swelling of arms or legs, cough, shortness of||
1233|039|S|breath.||
1233|040|S|   A very serious allergic reaction to this drug is rare.||
1233|041|S|However, get medical help right away if you notice any symptoms||
1233|042|S|of a serious allergic reaction, including: rash, itching/swelling||
1233|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1233|044|S|breathing.||
1233|045|S|   This is not a complete list of possible side effects. If you||
1233|046|S|notice other effects not listed above, contact your doctor or||
1233|047|S|pharmacist.||
1233|048|S|   In the US -||
1233|049|S|   Call your doctor for medical advice about side effects. You||
1233|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1233|051|S|www.fda.gov/medwatch.||
1233|052|S|   In Canada - Call your doctor for medical advice about side||
1233|053|S|effects. You may report side effects to Health Canada at||
1233|054|S|1-866-234-2345.||
1233|055|B|||
1233|056|P|PRECAUTIONS:  Before using trilaciclib, tell your doctor or||
1233|057|P|pharmacist if you are allergic to it; or if you have any other||
1233|058|P|allergies. This product may contain inactive ingredients, which||
1233|059|P|can cause allergic reactions or other problems. Talk to your||
1233|060|P|pharmacist for more details.||
1233|061|P|   Before using this medication, tell your doctor or pharmacist||
1233|062|P|your medical history, especially of: liver disease.||
1233|063|P|   Before having surgery, tell your doctor or dentist about all||
1233|064|P|the products you use (including prescription drugs,||
1233|065|P|nonprescription drugs, and herbal products).||
1233|066|P|   Tell your doctor if you are pregnant or plan to become||
1233|067|P|pregnant. You should not become pregnant while using trilaciclib.||
1233|068|P|Trilaciclib may harm an unborn baby. Your doctor should order a||
1233|069|P|pregnancy test before you start this medication. Ask about||
1233|070|P|reliable forms of birth control while using this medication and||
1233|071|P|for at least 3 weeks after the last dose. If you become pregnant,||
1233|072|P|talk to your doctor right away about the risks and benefits of||
1233|073|P|this medication.||
1233|074|P|   It is unknown if this drug passes into breast milk. Because of||
1233|075|P|the possible risk to the infant, breastfeeding is not recommended||
1233|076|P|while using this drug and for at least 3 weeks after the last||
1233|077|P|dose. Consult your doctor before breastfeeding.||
1233|078|B|||
1233|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1233|080|I|medications work or increase your risk for serious side effects.||
1233|081|I|This document does not contain all possible drug interactions.||
1233|082|I|Keep a list of all the products you use (including||
1233|083|I|prescription/nonprescription drugs and herbal products) and share||
1233|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
1233|085|I|the dosage of any medicines without your doctor's approval.||
1233|086|I|   A product that may interact with this drug is: dofetilide.||
1233|087|B|||
1233|088|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1233|089|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1233|090|O|poison control center right away. US residents can call||
1233|091|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1233|092|B|||
1233|093|N|NOTES:  Lab and/or medical tests (such as lung function, complete||
1233|094|N|blood count) may be done while you are using this medication.||
1233|095|N|Keep all medical and lab appointments. Consult your doctor for||
1233|096|N|more details.||
1233|097|B|||
1233|098|D|MISSED DOSE:  It is important to get each dose of this medication||
1233|099|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1233|100|D|right away for a new dosing schedule.||
1233|101|B|||
1233|102|R|STORAGE:  Not applicable. This medication is given in a hospital||
1233|103|R|or clinic and will not be stored at home.||
1233|104|R|   Do not flush medications down the toilet or pour them into a||
1233|105|R|drain unless instructed to do so. Properly discard this product||
1233|106|R|when it is expired or no longer needed. Consult your pharmacist||
1233|107|R|or local waste disposal company.||
1233|108|B|||
1233|109|A|Information last revised January 2025.||
1233|110|A|Copyright(c) 2025 First Databank, Inc.||
1233|111|B|||
1234|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1234|002|Z|does NOT have all possible information about this product. This||
1234|003|Z|information does not assure that this product is safe, effective,||
1234|004|Z|or appropriate for you. This information is not individual||
1234|005|Z|medical advice and does not substitute for the advice of your||
1234|006|Z|health care professional. Always ask your health care||
1234|007|Z|professional for complete information about this product and your||
1234|008|Z|specific health needs.||
1234|009|B|||
1234|010|T|PEGINTERFERON BETA 1A - INTRAMUSCULAR INJECTION||
1234|011|F|(peg-IN-ter-FEER-on BAY-ta wun-ay)||
1234|012|B|||
1234|013|C|COMMON BRAND NAME(S): Plegridy||
1234|014|B|||
1234|015|U|USES:  This medication is used to treat multiple sclerosis (MS).||
1234|016|U|Peginterferon is not a cure for MS, but it may help to decrease||
1234|017|U|the number of episodes of disease worsening (relapses) and slow||
1234|018|U|the worsening of the disease.||
1234|019|B|||
1234|020|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1234|021|H|provided by your pharmacist before you start using peginterferon||
1234|022|H|and each time you get a refill. Ask your health care professional||
1234|023|H|how to prepare and use this medication. If you have any||
1234|024|H|questions, ask your doctor or pharmacist.||
1234|025|H|   Inject this medication into a muscle as directed by your||
1234|026|H|doctor, usually every 14 days. The injection is given in the||
1234|027|H|thigh. Check the injection site 2 hours after injecting to see if||
1234|028|H|there is any reaction at the injection site. Tell the doctor of||
1234|029|H|any skin reactions that do not go away after a few days.||
1234|030|H|   To reduce your risk of side effects, your doctor may direct||
1234|031|H|you to start this medication at a low dose and gradually increase||
1234|032|H|your dose. A starter pack with different doses of this medication||
1234|033|H|may be used when starting this medication. Follow your doctor's||
1234|034|H|instructions carefully.||
1234|035|H|   Take the medication out of the refrigerator at least 30||
1234|036|H|minutes before you inject it to allow it to reach room||
1234|037|H|temperature. Do not warm up this medication any other way (for||
1234|038|H|example, place it in hot water). Before using, check this product||
1234|039|H|for particles or discoloration. If either is present, do not use||
1234|040|H|the liquid. Before injecting each dose, clean the skin you are||
1234|041|H|going to inject into (the injection site) with rubbing alcohol.||
1234|042|H|Change the injection site each time to lessen injury under the||
1234|043|H|skin. Do not inject into skin that is irritated, bruised,||
1234|044|H|scarred, or infected. Learn how to store and discard medical||
1234|045|H|supplies safely.||
1234|046|H|   Use this medication regularly to get the most benefit from it.||
1234|047|H|To help you remember, use it at the same time and same day of the||
1234|048|H|week.||
1234|049|H|   You may need to take other medications to reduce common side||
1234|050|H|effects such as fever and pain (such as acetaminophen,||
1234|051|H|ibuprofen). Consult your doctor or pharmacist about how to use||
1234|052|H|these medications safely with peginterferon.||
1234|053|H|   Tell your doctor if your condition gets worse.||
1234|054|B|||
1234|055|S|SIDE EFFECTS:  Pain, redness, itching, or swelling at the||
1234|056|S|injection site may occur. If any of these effects last or get||
1234|057|S|worse, tell your doctor or pharmacist promptly.||
1234|058|S|   Flu-like symptoms (such as headache, fever, chills, weakness,||
1234|059|S|nausea/vomiting, muscle aches/pain) may also occur, especially||
1234|060|S|when you first start this medication. You can reduce these side||
1234|061|S|effects by using fever reducers/pain relievers such as||
1234|062|S|acetaminophen or ibuprofen. Consult your doctor or pharmacist for||
1234|063|S|more information.||
1234|064|S|   Remember that this medication has been prescribed because your||
1234|065|S|doctor has judged that the benefit to you is greater than the||
1234|066|S|risk of side effects. Many people using this medication do not||
1234|067|S|have serious side effects.||
1234|068|S|   Tell your doctor right away if you have any serious side||
1234|069|S|effects, including: mental/mood changes (such as depression, rare||
1234|070|S|thoughts of suicide), signs of liver disease (such as||
1234|071|S|nausea/vomiting that doesn't stop, loss of appetite,||
1234|072|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), pus or||
1234|073|S|change in skin color (blue-black) at the injection site, signs of||
1234|074|S|infection (such as sore throat that doesn't go away, fever,||
1234|075|S|chills), easy bruising/bleeding, fast/slow/irregular heartbeat,||
1234|076|S|new or worsening symptoms of heart failure (such as shortness of||
1234|077|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
1234|078|S|weight gain), intolerance to cold or heat, signs of kidney||
1234|079|S|problems (such as a change in the amount of urine).||
1234|080|S|   Get medical help right away if you have any very serious side||
1234|081|S|effects, including: seizures, chest pain.||
1234|082|S|   A very serious allergic reaction to this drug is rare.||
1234|083|S|However, get medical help right away if you notice any symptoms||
1234|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1234|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1234|086|S|breathing.||
1234|087|S|   This is not a complete list of possible side effects. If you||
1234|088|S|notice other effects not listed above, contact your doctor or||
1234|089|S|pharmacist.||
1234|090|S|   In the US -||
1234|091|S|   Call your doctor for medical advice about side effects. You||
1234|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1234|093|S|www.fda.gov/medwatch.||
1234|094|S|   In Canada - Call your doctor for medical advice about side||
1234|095|S|effects. You may report side effects to Health Canada at||
1234|096|S|1-866-234-2345.||
1234|097|B|||
1234|098|P|PRECAUTIONS:  Before using peginterferon, tell your doctor or||
1234|099|P|pharmacist if you are allergic to it; or to interferon; or if you||
1234|100|P|have any other allergies. This product may contain inactive||
1234|101|P|ingredients (such as latex), which can cause allergic reactions||
1234|102|P|or other problems. Talk to your pharmacist for more details.||
1234|103|P|   Before using this medication, tell your doctor or pharmacist||
1234|104|P|your medical history, especially of: blood disorders (such as||
1234|105|P|anemia, low platelets, low white blood cells), bleeding problems,||
1234|106|P|heart disease (such as heart failure, angina, fast/irregular||
1234|107|P|heartbeat), liver disease, kidney disease, mental/mood disorders||
1234|108|P|(such as depression, psychosis, suicidal thoughts), seizures,||
1234|109|P|thyroid disease.||
1234|110|P|   Before having surgery, tell your doctor or dentist about all||
1234|111|P|the products you use (including prescription drugs,||
1234|112|P|nonprescription drugs, and herbal products).||
1234|113|P|   During pregnancy, this medication should be used only when||
1234|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
1234|115|P|   This medication passes into breast milk, but is unlikely to||
1234|116|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1234|117|B|||
1234|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1234|119|I|medications work or increase your risk for serious side effects.||
1234|120|I|This document does not contain all possible drug interactions.||
1234|121|I|Keep a list of all the products you use (including||
1234|122|I|prescription/nonprescription drugs and herbal products) and share||
1234|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
1234|124|I|the dosage of any medicines without your doctor's approval.||
1234|125|B|||
1234|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1234|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1234|128|O|poison control center right away. US residents can call||
1234|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1234|130|B|||
1234|131|N|NOTES:  Do not share this medication with others.||
1234|132|N|   Lab and/or medical tests (such as liver function, complete||
1234|133|N|blood count) may be done while you are using this medication.||
1234|134|N|Keep all medical and lab appointments. Consult your doctor for||
1234|135|N|more details.||
1234|136|B|||
1234|137|D|MISSED DOSE:  It is important to use each dose of this medication||
1234|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1234|139|D|right away for a new dosing schedule. Do not double the dose to||
1234|140|D|catch up.||
1234|141|B|||
1234|142|R|STORAGE:  Store in the refrigerator. Do not freeze. Do not use||
1234|143|R|the medication if it has been frozen. Keep the medication in the||
1234|144|R|original carton to protect from light. This medication may be||
1234|145|R|taken out of the refrigerator and put back in the refrigerator if||
1234|146|R|needed. The total time out of the refrigerator should not be more||
1234|147|R|than 30 days. Keep all medications away from children and pets.||
1234|148|R|   Do not flush medications down the toilet or pour them into a||
1234|149|R|drain unless instructed to do so. Properly discard this product||
1234|150|R|when it is expired or no longer needed. Consult your pharmacist||
1234|151|R|or local waste disposal company.||
1234|152|B|||
1234|153|A|Information last revised April 2025.||
1234|154|A|Copyright(c) 2025 First Databank, Inc.||
1234|155|B|||
1235|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1235|002|Z|does NOT have all possible information about this product. This||
1235|003|Z|information does not assure that this product is safe, effective,||
1235|004|Z|or appropriate for you. This information is not individual||
1235|005|Z|medical advice and does not substitute for the advice of your||
1235|006|Z|health care professional. Always ask your health care||
1235|007|Z|professional for complete information about this product and your||
1235|008|Z|specific health needs.||
1235|009|B|||
1235|010|T|MOXIFLOXACIN - ORAL||
1235|011|F|(mox-ih-FLOX-uh-sin)||
1235|012|B|||
1235|013|C|COMMON BRAND NAME(S): Avelox||
1235|014|B|||
1235|015|W|WARNING:  Quinolone antibiotics (including moxifloxacin) may||
1235|016|W|cause serious and possibly permanent tendon damage (such as||
1235|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
1235|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
1235|019|W|help right away if you have any of the following symptoms:||
1235|020|W|pain/numbness/burning/tingling/weakness in your||
1235|021|W|arms/hands/legs/feet, changes in how you sense||
1235|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
1235|023|W|headache, vision changes, shaking (tremors), seizures,||
1235|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
1235|025|W|hallucinations, depression, rare thoughts of suicide).||
1235|026|W|   Tendon damage may occur during or after treatment with this||
1235|027|W|medication. Stop exercising, rest, and get medical help right||
1235|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
1235|029|W|risk for tendon problems is greater if you are over 60 years of||
1235|030|W|age, if you are taking corticosteroids (such as prednisone), or||
1235|031|W|if you have a kidney, heart, or lung transplant.||
1235|032|W|   This medication may make a certain muscle condition||
1235|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
1235|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
1235|035|W|unsteady walk) or trouble breathing.||
1235|036|W|   Discuss the risks and benefits with your doctor before using||
1235|037|W|this medication.||
1235|038|B|||
1235|039|U|USES:  Moxifloxacin is used to treat a variety of bacterial||
1235|040|U|infections. This medication belongs to a class of drugs called||
1235|041|U|quinolone antibiotics. It works by stopping the growth of||
1235|042|U|bacteria.||
1235|043|U|   This antibiotic treats only bacterial infections. It will not||
1235|044|U|work for virus infections (such as common cold, flu). Using any||
1235|045|U|antibiotic when it is not needed can cause it to not work for||
1235|046|U|future infections.||
1235|047|B|||
1235|048|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1235|049|H|Patient Information Leaflet provided by your pharmacist before||
1235|050|H|you start using moxifloxacin and each time you get a refill. If||
1235|051|H|you have any questions, ask your doctor or pharmacist.||
1235|052|H|   Take this medication by mouth with or without food as directed||
1235|053|H|by your doctor, usually once daily. The dosage and length of||
1235|054|H|treatment are based on your medical condition and response to||
1235|055|H|treatment. Drink plenty of fluids while taking this drug unless||
1235|056|H|your doctor tells you otherwise.||
1235|057|H|   Take this medication at least 4 hours before or 8 hours after||
1235|058|H|taking other products that may bind to it, decreasing its||
1235|059|H|effectiveness. Ask your pharmacist about the other products you||
1235|060|H|take. Some examples include: quinapril, sucralfate,||
1235|061|H|vitamins/minerals (including iron and zinc supplements), and||
1235|062|H|products containing magnesium, aluminum, or calcium (such as||
1235|063|H|antacids, calcium supplements).||
1235|064|H|   For the best effect, take this antibiotic at evenly spaced||
1235|065|H|times. To help you remember, take this medication at the same||
1235|066|H|time(s) every day.||
1235|067|H|   Continue to take this medication until the full prescribed||
1235|068|H|amount is finished, even if symptoms disappear after a few days.||
1235|069|H|Stopping the medication too early may result in a return of the||
1235|070|H|infection.||
1235|071|H|   Tell your doctor if your condition lasts or gets worse.||
1235|072|B|||
1235|073|S|SIDE EFFECTS:  See also Warning section.||
1235|074|S|   Nausea, diarrhea, dizziness, lightheadedness, headache,||
1235|075|S|weakness, or trouble sleeping may occur. If any of these effects||
1235|076|S|last or get worse, tell your doctor or pharmacist promptly.||
1235|077|S|   Remember that this medication has been prescribed because your||
1235|078|S|doctor has judged that the benefit to you is greater than the||
1235|079|S|risk of side effects. Many people using this medication do not||
1235|080|S|have serious side effects.||
1235|081|S|   Tell your doctor right away if you have any serious side||
1235|082|S|effects, including: unusual bruising/bleeding, signs of a new||
1235|083|S|infection (such as sore throat that doesn't go away, fever),||
1235|084|S|signs of kidney problems (such as change in the amount of urine),||
1235|085|S|signs of liver problems (such as nausea/vomiting that doesn't||
1235|086|S|stop, unusual tiredness, stomach/abdominal pain, yellowing||
1235|087|S|eyes/skin, dark urine).||
1235|088|S|   Get medical help right away if you have any very serious side||
1235|089|S|effects, including: severe dizziness, fainting, fast/irregular||
1235|090|S|heartbeat, signs of a tear/break in the main blood vessel called||
1235|091|S|the aorta (such as sudden/severe pain in the stomach/chest/back,||
1235|092|S|shortness of breath).||
1235|093|S|   This medication may rarely cause a severe intestinal condition||
1235|094|S|due to a bacteria called C. difficile. This condition may occur||
1235|095|S|during treatment or weeks to months after treatment has stopped.||
1235|096|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1235|097|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1235|098|S|stool.||
1235|099|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1235|100|S|products because they may make symptoms worse.||
1235|101|S|   Use of this medication for prolonged or repeated periods may||
1235|102|S|result in oral thrush or a new yeast infection. Contact your||
1235|103|S|doctor if you notice white patches in your mouth, a change in||
1235|104|S|vaginal discharge, or other new symptoms.||
1235|105|S|   A very serious allergic reaction to this drug is rare.||
1235|106|S|However, get medical help right away if you notice any symptoms||
1235|107|S|of a serious allergic reaction, including: rash, itching/swelling||
1235|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1235|109|S|breathing.||
1235|110|S|   This is not a complete list of possible side effects. If you||
1235|111|S|notice other effects not listed above, contact your doctor or||
1235|112|S|pharmacist.||
1235|113|S|   In the US -||
1235|114|S|   Call your doctor for medical advice about side effects. You||
1235|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1235|116|S|www.fda.gov/medwatch.||
1235|117|S|   In Canada - Call your doctor for medical advice about side||
1235|118|S|effects. You may report side effects to Health Canada at||
1235|119|S|1-866-234-2345.||
1235|120|B|||
1235|121|P|PRECAUTIONS:  See also Warning section.||
1235|122|P|   Before taking moxifloxacin, tell your doctor or pharmacist if||
1235|123|P|you are allergic to it; or to other quinolone antibiotics (such||
1235|124|P|as ciprofloxacin, levofloxacin); or if you have any other||
1235|125|P|allergies. This product may contain inactive ingredients, which||
1235|126|P|can cause allergic reactions or other problems. Talk to your||
1235|127|P|pharmacist for more details.||
1235|128|P|   Before using this medication, tell your doctor or pharmacist||
1235|129|P|your medical history, especially of: diabetes, heart problems||
1235|130|P|(such as recent heart attack), joint/tendon problems (such as||
1235|131|P|tendonitis, bursitis), liver disease, mental/mood disorders (such||
1235|132|P|as depression), myasthenia gravis, nerve problems (such as||
1235|133|P|peripheral neuropathy), seizure disorder, conditions that||
1235|134|P|increase your risk of seizures (such as brain/head injury, brain||
1235|135|P|tumors, cerebral atherosclerosis), blood vessel problems (such as||
1235|136|P|aneurysm or blockage of the aorta or other blood vessels,||
1235|137|P|hardening of the arteries), high blood pressure, certain genetic||
1235|138|P|conditions (Marfan syndrome, Ehlers-Danlos syndrome).||
1235|139|P|   Moxifloxacin may cause a condition that affects the heart||
1235|140|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1235|141|P|serious (rarely fatal) fast/irregular heartbeat and other||
1235|142|P|symptoms (such as severe dizziness, fainting) that need medical||
1235|143|P|attention right away.||
1235|144|P|   The risk of QT prolongation may be increased if you have||
1235|145|P|certain medical conditions or are taking other drugs that may||
1235|146|P|cause QT prolongation. Before using moxifloxacin, tell your||
1235|147|P|doctor or pharmacist of all the drugs you take and if you have||
1235|148|P|any of the following conditions: certain heart problems (heart||
1235|149|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1235|150|P|history of certain heart problems (QT prolongation in the EKG,||
1235|151|P|sudden cardiac death).||
1235|152|P|   Low levels of potassium or magnesium in the blood may also||
1235|153|P|increase your risk of QT prolongation. This risk may increase if||
1235|154|P|you use certain drugs (such as diuretics/"water pills") or if you||
1235|155|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1235|156|P|Talk to your doctor about using moxifloxacin safely.||
1235|157|P|   This medication may rarely cause serious changes in blood||
1235|158|P|sugar, especially if you have diabetes. Check your blood sugar||
1235|159|P|regularly as directed and share the results with your doctor.||
1235|160|P|Watch for symptoms of high blood sugar, such as increased||
1235|161|P|thirst/urination. Also watch for symptoms of low blood sugar such||
1235|162|P|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
1235|163|P|vision, dizziness, or tingling hands/feet. It is a good habit to||
1235|164|P|carry glucose tablets or gel to treat low blood sugar. If you||
1235|165|P|don't have these reliable forms of glucose, rapidly raise your||
1235|166|P|blood sugar by eating a quick source of sugar such as table||
1235|167|P|sugar, honey, or candy, or by drinking fruit juice or non-diet||
1235|168|P|soda. Tell your doctor right away about the reaction and the use||
1235|169|P|of this product. To help prevent low blood sugar, eat meals on a||
1235|170|P|regular schedule, and do not skip meals. Your doctor may need to||
1235|171|P|switch you to another antibiotic or adjust your diabetes||
1235|172|P|medications if any reaction occurs.||
1235|173|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1235|174|P|can make you more dizzy. Do not drive, use machinery, or do||
1235|175|P|anything that needs alertness until you can do it safely. Limit||
1235|176|P|alcoholic beverages. Talk to your doctor if you are using||
1235|177|P|marijuana (cannabis).||
1235|178|P|   This medication may make you more sensitive to the sun. Limit||
1235|179|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1235|180|P|sunscreen and wear protective clothing when outdoors. Tell your||
1235|181|P|doctor right away if you get sunburned or have skin||
1235|182|P|blisters/redness.||
1235|183|P|   Moxifloxacin may cause live bacterial vaccines (such as||
1235|184|P|typhoid vaccine) to not work well. Tell your health care||
1235|185|P|professional that you are using moxifloxacin before having any||
1235|186|P|immunizations/vaccinations.||
1235|187|P|   Before having surgery, tell your doctor or dentist about all||
1235|188|P|the products you use (including prescription drugs,||
1235|189|P|nonprescription drugs, and herbal products).||
1235|190|P|   Children may be more sensitive to the side effects of this||
1235|191|P|drug, especially joint/tendon problems.||
1235|192|P|   Older adults may be at greater risk for tendon problems||
1235|193|P|(especially if they are also taking corticosteroids such as||
1235|194|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
1235|195|P|tear/break in the main blood vessel (aorta).||
1235|196|P|   During pregnancy, this medication should be used only when||
1235|197|P|clearly needed. Discuss the risks and benefits with your doctor.||
1235|198|P|   It is unknown if this drug passes into breast milk. Consult||
1235|199|P|your doctor before breastfeeding.||
1235|200|B|||
1235|201|I|DRUG INTERACTIONS:  See also Warning, How to Use, and Precautions||
1235|202|I|sections.||
1235|203|I|   Drug interactions may change how your medications work or||
1235|204|I|increase your risk for serious side effects. This document does||
1235|205|I|not contain all possible drug interactions. Keep a list of all||
1235|206|I|the products you use (including prescription/nonprescription||
1235|207|I|drugs and herbal products) and share it with your doctor and||
1235|208|I|pharmacist. Do not start, stop, or change the dosage of any||
1235|209|I|medicines without your doctor's approval.||
1235|210|I|   Some products that may interact with this drug include: "blood||
1235|211|I|thinners" (such as acenocoumarol, warfarin), strontium.||
1235|212|I|   Many drugs besides moxifloxacin may affect the heart rhythm||
1235|213|I|(QT prolongation), including amiodarone, dofetilide,||
1235|214|I|procainamide, quinidine, sotalol, ziprasidone, among others.||
1235|215|B|||
1235|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1235|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1235|218|O|poison control center right away. US residents can call||
1235|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1235|220|B|||
1235|221|N|NOTES:  Do not share this medication with others.||
1235|222|N|   This medication has been prescribed for your current condition||
1235|223|N|only. Do not use it later for another infection unless your||
1235|224|N|doctor tells you to.||
1235|225|N|   Lab and/or medical tests (such as liver function, complete||
1235|226|N|blood count, blood glucose) should be done while you are taking||
1235|227|N|this medication. Keep all medical and lab appointments. Consult||
1235|228|N|your doctor for more details.||
1235|229|B|||
1235|230|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1235|231|D|remember. If it is less than 8 hours before the next dose, skip||
1235|232|D|the missed dose. Take your next dose at the regular time. Do not||
1235|233|D|double the dose to catch up.||
1235|234|B|||
1235|235|R|STORAGE:  Store at room temperature away from light and moisture.||
1235|236|R|Do not store in the bathroom. Keep all medications away from||
1235|237|R|children and pets.||
1235|238|R|   Do not flush medications down the toilet or pour them into a||
1235|239|R|drain unless instructed to do so. Properly discard this product||
1235|240|R|when it is expired or no longer needed. Consult your pharmacist||
1235|241|R|or local waste disposal company.||
1235|242|B|||
1235|243|A|Information last revised May 2024.||
1235|244|A|Copyright(c) 2025 First Databank, Inc.||
1235|245|B|||
1237|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1237|002|Z|does NOT have all possible information about this product. This||
1237|003|Z|information does not assure that this product is safe, effective,||
1237|004|Z|or appropriate for you. This information is not individual||
1237|005|Z|medical advice and does not substitute for the advice of your||
1237|006|Z|health care professional. Always ask your health care||
1237|007|Z|professional for complete information about this product and your||
1237|008|Z|specific health needs.||
1237|009|B|||
1237|010|T|PAZOPANIB - ORAL||
1237|011|F|(paz-OH-pa-nib)||
1237|012|B|||
1237|013|C|COMMON BRAND NAME(S): Votrient||
1237|014|B|||
1237|015|W|WARNING:  Pazopanib can rarely cause very serious (possibly||
1237|016|W|fatal) liver disease. Your doctor will order blood tests to check||
1237|017|W|your liver before you start and while you are taking pazopanib.||
1237|018|W|During the first 2 months of treatment, liver tests will be done||
1237|019|W|often, usually every 2 weeks. After 2 months, liver testing will||
1237|020|W|be less frequent. Tell your doctor right away if you develop||
1237|021|W|symptoms of liver disease such as nausea/vomiting that doesn't||
1237|022|W|stop, dark urine, yellow eyes/skin, stomach/abdominal pain. Your||
1237|023|W|doctor may need to change your dosage or discontinue the drug.||
1237|024|B|||
1237|025|U|USES:  Pazopanib is used to treat certain types of cancer||
1237|026|U|(kidney, soft tissue sarcoma). Pazopanib belongs to a class of||
1237|027|U|drugs known as tyrosine kinase inhibitors. It works by decreasing||
1237|028|U|the blood supply to the cancer tumor to slow tumor growth.||
1237|029|U|   This medication should not be used by children, especially||
1237|030|U|those younger than 2 years of age, because of the risk of serious||
1237|031|U|side effects.||
1237|032|B|||
1237|033|H|HOW TO USE:  Read the Medication Guide provided by your||
1237|034|H|pharmacist before you start taking pazopanib and each time you||
1237|035|H|get a refill. If you have any questions, ask your doctor or||
1237|036|H|pharmacist.||
1237|037|H|   Take this medication by mouth without food as directed by your||
1237|038|H|doctor, usually once daily. It is very important to take this||
1237|039|H|medication on an empty stomach, at least 1 hour before or 2 hours||
1237|040|H|after food.||
1237|041|H|   Swallow this medication whole. Do not crush, chew, or break||
1237|042|H|the tablets. Doing so can release all of the drug at once,||
1237|043|H|increasing the risk of side effects.||
1237|044|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1237|045|H|using this medication unless your doctor or pharmacist says you||
1237|046|H|may do so safely. Grapefruit can increase the chance of side||
1237|047|H|effects with this medicine. Ask your doctor or pharmacist for||
1237|048|H|more details.||
1237|049|H|   Medications that reduce stomach acid (such as antacids, proton||
1237|050|H|pump inhibitors/PPIs, H2 blockers) may make pazopanib work less||
1237|051|H|well. Do not take PPIs (such as lansoprazole, omeprazole) or H2||
1237|052|H|blockers (such as famotidine, nizatidine) while using this||
1237|053|H|medication. If you take antacids, take the antacids at least||
1237|054|H|several hours before or after pazopanib.||
1237|055|H|   The dosage is based on your medical condition, lab tests,||
1237|056|H|response to treatment, and other medications you may be taking.||
1237|057|H|Be sure to tell your doctor and pharmacist about all the products||
1237|058|H|you use (including prescription drugs, nonprescription drugs, and||
1237|059|H|herbal products).||
1237|060|H|   Your doctor will order lab tests to find the best dose for||
1237|061|H|you. Keep all medical and lab appointments.||
1237|062|H|   Do not increase your dose or take this drug more often than||
1237|063|H|prescribed. Your condition will not improve any faster, and your||
1237|064|H|risk of serious side effects will increase. Use this medication||
1237|065|H|regularly to get the most benefit from it. To help you remember,||
1237|066|H|take it at the same time each day. Follow your doctor's||
1237|067|H|instructions carefully.||
1237|068|H|   Since this medication can be absorbed through the skin and||
1237|069|H|lungs, women who are pregnant or who may become pregnant should||
1237|070|H|not handle this medication or breathe the dust from the tablets.||
1237|071|H|   Tell your doctor if your condition gets worse.||
1237|072|B|||
1237|073|S|SIDE EFFECTS:  See also Warning section.||
1237|074|S|   Diarrhea, nausea/vomiting, headache, loss of appetite, weight||
1237|075|S|loss, altered sense of taste, numbness/tingling/redness in||
1237|076|S|hands/feet, or feeling tired/weak may occur. If these effects||
1237|077|S|last or get worse, tell your doctor or pharmacist promptly.||
1237|078|S|   Temporary hair loss and/or change in hair or skin color may||
1237|079|S|occur. Normal hair growth should return after treatment has||
1237|080|S|ended.||
1237|081|S|   People using this medication may have serious side effects.||
1237|082|S|However, you have been prescribed this drug because your doctor||
1237|083|S|has judged that the benefit to you is greater than the risk of||
1237|084|S|side effects. Careful monitoring by your doctor may decrease your||
1237|085|S|risk.||
1237|086|S|   Tell your doctor right away if you have any serious side||
1237|087|S|effects, including: symptoms of heart failure (such as swelling||
1237|088|S|ankles/feet, unusual tiredness), signs of an underactive thyroid||
1237|089|S|(such as unusual weight gain, cold intolerance, slow heartbeat),||
1237|090|S|signs of infection (such as sore throat that doesn't go away,||
1237|091|S|fever, chills), wounds that do not heal.||
1237|092|S|   This drug can cause serious (rarely fatal) bleeding. Tell your||
1237|093|S|doctor right away if you have any signs of unusual bleeding such||
1237|094|S|as: bloody/black stools, easy bleeding/bruising (such as nose||
1237|095|S|bleed or bloody/pinkish urine), vomit that looks like coffee||
1237|096|S|grounds, severe stomach/abdominal pain, coughing up blood.||
1237|097|S|   Pazopanib sometimes causes side effects due to the rapid||
1237|098|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1237|099|S|risk, your doctor may add a medication and tell you to drink||
1237|100|S|plenty of fluids. Tell your doctor right away if you have||
1237|101|S|symptoms such as: signs of kidney problems (such as painful||
1237|102|S|urination, pink/bloody urine, change in the amount of urine),||
1237|103|S|muscle spasms/weakness.||
1237|104|S|   This medication may raise your blood pressure. Check your||
1237|105|S|blood pressure regularly and tell your doctor if the results are||
1237|106|S|high. Your doctor may control your blood pressure with||
1237|107|S|medication.||
1237|108|S|   Get medical help right away if you have any very serious side||
1237|109|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1237|110|S|fainting, symptoms of a heart attack (such as chest/jaw/left arm||
1237|111|S|pain, shortness of breath, unusual sweating), signs of a stroke||
1237|112|S|(such as weakness on one side of the body, trouble speaking,||
1237|113|S|vision changes, confusion), pain/redness/swelling in the||
1237|114|S|arm/leg/calf/groin, signs of a certain brain condition (such as||
1237|115|S|headache, seizure, decreased alertness, blindness), sudden/severe||
1237|116|S|back pain.||
1237|117|S|   A very serious allergic reaction to this drug is rare.||
1237|118|S|However, get medical help right away if you notice any symptoms||
1237|119|S|of a serious allergic reaction, including: rash, itching/swelling||
1237|120|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1237|121|S|breathing.||
1237|122|S|   This is not a complete list of possible side effects. If you||
1237|123|S|notice other effects not listed above, contact your doctor or||
1237|124|S|pharmacist.||
1237|125|S|   In the US -||
1237|126|S|   Call your doctor for medical advice about side effects. You||
1237|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1237|128|S|www.fda.gov/medwatch.||
1237|129|S|   In Canada - Call your doctor for medical advice about side||
1237|130|S|effects. You may report side effects to Health Canada at||
1237|131|S|1-866-234-2345.||
1237|132|B|||
1237|133|P|PRECAUTIONS:  Before taking pazopanib, tell your doctor or||
1237|134|P|pharmacist if you are allergic to it; or if you have any other||
1237|135|P|allergies. This product may contain inactive ingredients, which||
1237|136|P|can cause allergic reactions or other problems. Talk to your||
1237|137|P|pharmacist for more details.||
1237|138|P|   Before using this medication, tell your doctor or pharmacist||
1237|139|P|your medical history, especially of: liver disease, chest||
1237|140|P|pain/heart attack, high blood pressure, stroke, recent||
1237|141|P|surgery/injury, bleeding/clotting problem, blood vessel problems||
1237|142|P|(such as an aneurysm or a tear/break in the aorta or other blood||
1237|143|P|vessels), intestinal or stomach problems (such as ulcer, fistula,||
1237|144|P|pancreatitis), underactive thyroid.||
1237|145|P|   Pazopanib may cause a condition that affects the heart rhythm||
1237|146|P|(QT prolongation). QT prolongation can rarely cause serious||
1237|147|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1237|148|P|as severe dizziness, fainting) that need medical attention right||
1237|149|P|away.||
1237|150|P|   The risk of QT prolongation may be increased if you have||
1237|151|P|certain medical conditions or are taking other drugs that may||
1237|152|P|cause QT prolongation. Before using pazopanib, tell your doctor||
1237|153|P|or pharmacist of all the drugs you take and if you have any of||
1237|154|P|the following conditions: certain heart problems (heart failure,||
1237|155|P|slow heartbeat, QT prolongation in the EKG), family history of||
1237|156|P|certain heart problems (QT prolongation in the EKG, sudden||
1237|157|P|cardiac death).||
1237|158|P|   Low levels of potassium or magnesium in the blood may also||
1237|159|P|increase your risk of QT prolongation. This risk may increase if||
1237|160|P|you use certain drugs (such as diuretics/"water pills") or if you||
1237|161|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1237|162|P|Talk to your doctor about using pazopanib safely.||
1237|163|P|   Before having surgery, tell your doctor or dentist about all||
1237|164|P|the products you use (including prescription drugs,||
1237|165|P|nonprescription drugs, and herbal products).||
1237|166|P|   This medication may cause wounds to heal slowly or poorly.||
1237|167|P|Before having surgery, talk with your doctor about the risks and||
1237|168|P|benefits of this medication. Your doctor may tell you to||
1237|169|P|temporarily stop treatment with this medication at least 1 week||
1237|170|P|before surgery. Ask your doctor for specific instructions about||
1237|171|P|when to stop and when to restart treatment with pazopanib. Tell||
1237|172|P|your doctor right away if you have wounds that are not healing||
1237|173|P|well.||
1237|174|P|   To lower the chance of getting cut, bruised, or injured, use||
1237|175|P|caution with sharp objects like razors and nail cutters, and||
1237|176|P|avoid activities such as contact sports.||
1237|177|P|   Older adults may be more sensitive to the side effects of this||
1237|178|P|drug, especially liver disease or QT prolongation (see above).||
1237|179|P|   Tell your doctor if you are pregnant or plan to become||
1237|180|P|pregnant. You should not become pregnant while using pazopanib.||
1237|181|P|Pazopanib may harm an unborn baby. Your doctor should order a||
1237|182|P|pregnancy test before you start this medication. Men and women||
1237|183|P|using this medication should ask about reliable forms of birth||
1237|184|P|control during treatment and for at least 2 weeks after the last||
1237|185|P|dose. If you or your partner becomes pregnant, talk to your||
1237|186|P|doctor right away about the risks and benefits of this||
1237|187|P|medication.||
1237|188|P|   It is unknown if this medication passes into breast milk.||
1237|189|P|Because of the possible risk to the infant, breastfeeding is not||
1237|190|P|recommended while using this medication and for 2 weeks after the||
1237|191|P|last dose. Consult your doctor before breastfeeding.||
1237|192|B|||
1237|193|I|DRUG INTERACTIONS:  See also How to Use section.||
1237|194|I|   Drug interactions may change how your medications work or||
1237|195|I|increase your risk for serious side effects. This document does||
1237|196|I|not contain all possible drug interactions. Keep a list of all||
1237|197|I|the products you use (including prescription/nonprescription||
1237|198|I|drugs and herbal products) and share it with your doctor and||
1237|199|I|pharmacist. Do not start, stop, or change the dosage of any||
1237|200|I|medicines without your doctor's approval.||
1237|201|I|   Some products that may interact with this drug include:||
1237|202|I|irinotecan, other drugs that can cause bleeding/bruising||
1237|203|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
1237|204|I|ibuprofen, "blood thinners" such as warfarin).||
1237|205|I|   Aspirin can increase the risk of bleeding when used with this||
1237|206|I|medication. However, if your doctor has told you to take low-dose||
1237|207|I|aspirin to prevent heart attack or stroke (usually 81-162||
1237|208|I|milligrams a day), you should keep taking the aspirin unless your||
1237|209|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1237|210|I|details.||
1237|211|I|   Other medications can affect the removal of pazopanib from||
1237|212|I|your body, which may affect how pazopanib works. Examples include||
1237|213|I|azole antifungals (such as ketoconazole), nefazodone, rifamycins||
1237|214|I|(such as rifabutin, rifampin), ritonavir, St. John's wort, drugs||
1237|215|I|used to treat seizures (such as carbamazepine, phenobarbital,||
1237|216|I|phenytoin, primidone), among others.||
1237|217|I|   Many drugs besides pazopanib may affect the heart rhythm (QT||
1237|218|I|prolongation), including amiodarone, dofetilide, pimozide,||
1237|219|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
1237|220|I|clarithromycin, erythromycin), among others. Before using this||
1237|221|I|drug, report all medications you are currently using to your||
1237|222|I|doctor or pharmacist.||
1237|223|B|||
1237|224|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1237|225|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1237|226|O|poison control center right away. US residents can call||
1237|227|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1237|228|B|||
1237|229|N|NOTES:  Do not share this medication with others.||
1237|230|N|   Lab and/or medical tests (such as EKG, blood pressure,||
1237|231|N|complete blood count, liver/thyroid function, blood minerals,||
1237|232|N|urine protein) should be done while you are taking this||
1237|233|N|medication. Keep all medical and lab appointments. Consult your||
1237|234|N|doctor for more details.||
1237|235|B|||
1237|236|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1237|237|D|remember. If it is less than 12 hours before your next dose, skip||
1237|238|D|the missed dose. Take your next dose at the regular time. Do not||
1237|239|D|double the dose to catch up.||
1237|240|B|||
1237|241|R|STORAGE:  Store at room temperature away from light and moisture.||
1237|242|R|Do not store in the bathroom. Keep all medications away from||
1237|243|R|children and pets.||
1237|244|R|   Do not flush medications down the toilet or pour them into a||
1237|245|R|drain unless instructed to do so. Properly discard this product||
1237|246|R|when it is expired or no longer needed. Consult your pharmacist||
1237|247|R|or local waste disposal company.||
1237|248|B|||
1237|249|M|MEDICAL ALERT:  Your condition can cause complications in a||
1237|250|M|medical emergency. For information about enrolling in MedicAlert,||
1237|251|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1237|252|B|||
1237|253|A|Information last revised June 2025.||
1237|254|A|Copyright(c) 2025 First Databank, Inc.||
1237|255|B|||
1239|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1239|002|Z|does NOT have all possible information about this product. This||
1239|003|Z|information does not assure that this product is safe, effective,||
1239|004|Z|or appropriate for you. This information is not individual||
1239|005|Z|medical advice and does not substitute for the advice of your||
1239|006|Z|health care professional. Always ask your health care||
1239|007|Z|professional for complete information about this product and your||
1239|008|Z|specific health needs.||
1239|009|B|||
1239|010|T|MORPHINE SUSTAINED-ACTION CAPSULE - ORAL||
1239|011|F|(MORE-feen)||
1239|012|B|||
1239|013|C|COMMON BRAND NAME(S): Kadian||
1239|014|B|||
1239|015|W|WARNING:  Morphine has a risk for abuse and addiction, which can||
1239|016|W|lead to overdose and death. Morphine may also cause severe,||
1239|017|W|possibly fatal, breathing problems. To lower your risk, your||
1239|018|W|doctor should have you take the smallest dose of morphine that||
1239|019|W|works, and take it for the shortest possible time. See also How||
1239|020|W|to Use section for more information about addiction.||
1239|021|W|   Ask your doctor or pharmacist if you should have medication||
1239|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1239|023|W|Teach your family or household members about the signs of an||
1239|024|W|opioid overdose and how to treat it.||
1239|025|W|   The risk for severe breathing problems is higher when you||
1239|026|W|start this medication and after a dose increase, or if you take||
1239|027|W|the wrong dose/strength. Taking this medication with alcohol or||
1239|028|W|other drugs that can cause drowsiness or breathing problems may||
1239|029|W|cause very serious side effects, including death. Be sure you||
1239|030|W|know how to take morphine and what other drugs you should avoid||
1239|031|W|taking with it. See also Drug Interactions section. Get medical||
1239|032|W|help right away if any of these very serious side effects occur:||
1239|033|W|slow/shallow breathing, unusual lightheadedness, severe||
1239|034|W|drowsiness/dizziness, difficulty waking up.||
1239|035|W|   Do not crush, chew, or dissolve this medication or the||
1239|036|W|contents of the capsules. Taking crushed, chewed, or dissolved||
1239|037|W|forms of sustained-action morphine could cause a fatal overdose.||
1239|038|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1239|039|W|or abuse. If someone accidentally swallows this drug, get medical||
1239|040|W|help right away.||
1239|041|W|   Before using this medication, women of childbearing age should||
1239|042|W|talk with their doctor(s) about the risks and benefits. Tell your||
1239|043|W|doctor if you are pregnant or if you plan to become pregnant.||
1239|044|W|During pregnancy, this medication should be used only when||
1239|045|W|clearly needed. It may slightly increase the risk of birth||
1239|046|W|defects if used during the first two months of pregnancy. Also,||
1239|047|W|using it for a long time or in high doses near the expected||
1239|048|W|delivery date may harm the unborn baby. To lessen the risk, take||
1239|049|W|the smallest effective dose for the shortest possible time.||
1239|050|W|Babies born to mothers who use this drug for a long time may||
1239|051|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1239|052|W|doctor right away if you notice any symptoms in your newborn baby||
1239|053|W|such as crying that doesn't stop, slow/shallow breathing,||
1239|054|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1239|055|W|difficulty gaining weight.||
1239|056|B|||
1239|057|U|USES:  This medication is used to help relieve severe ongoing||
1239|058|U|pain (such as due to cancer). Morphine belongs to a class of||
1239|059|U|drugs known as opioid analgesics. It works in the brain to change||
1239|060|U|how your body feels and responds to pain.||
1239|061|U|   The higher strengths of this drug (100 milligrams per capsule||
1239|062|U|and higher) should be used only if you have been regularly taking||
1239|063|U|moderate to large amounts of an opioid pain medication. These||
1239|064|U|strengths may cause overdose (even death) if taken by a person||
1239|065|U|who has not been regularly taking opioids.||
1239|066|U|   Do not use the sustained-action form of morphine to relieve||
1239|067|U|pain that is mild or that will go away in a few days. This||
1239|068|U|medication is not for occasional ("as needed") use.||
1239|069|B|||
1239|070|H|HOW TO USE:  See also Warning section.||
1239|071|H|   Read the Medication Guide provided by your pharmacist before||
1239|072|H|you start using morphine and each time you get a refill. If you||
1239|073|H|have any questions, consult your doctor or pharmacist.||
1239|074|H|   Take this medication on a regular schedule as directed by your||
1239|075|H|doctor, not as needed for sudden (breakthrough) pain. Take this||
1239|076|H|drug with or without food, usually once or twice daily (every 12||
1239|077|H|or 24 hours). If you have nausea, it may help to take this drug||
1239|078|H|with food. Ask your doctor or pharmacist about other ways to||
1239|079|H|decrease nausea (such as lying down for 1 to 2 hours with as||
1239|080|H|little head movement as possible).||
1239|081|H|   Swallow the capsules whole. Adults who have trouble swallowing||
1239|082|H|the capsule may open the capsule and carefully sprinkle its||
1239|083|H|contents on a spoonful of soft, cool applesauce. Swallow all of||
1239|084|H|the drug/food mixture right away without chewing. Then rinse your||
1239|085|H|mouth and swallow the rinse liquid to make sure that you have||
1239|086|H|swallowed all of the dose. Do not chew the mixture or prepare a||
1239|087|H|supply in advance. Do not give this medication to a child this||
1239|088|H|way, since they might chew the mixture and overdose. For children||
1239|089|H|who have trouble swallowing the capsule, ask the doctor about||
1239|090|H|using a different form of morphine instead.||
1239|091|H|   The dosage is based on your medical condition and response to||
1239|092|H|treatment. Do not increase your dose, take the medication more||
1239|093|H|often, or take it for a longer time than prescribed. Properly||
1239|094|H|stop the medication when so directed.||
1239|095|H|   If you are giving this medication through a certain tube into||
1239|096|H|the stomach (gastric tube), ask your health care professional for||
1239|097|H|detailed instructions on how to give it.||
1239|098|H|   Before you start taking this medication, ask your doctor or||
1239|099|H|pharmacist if you should stop or change how you use your other||
1239|100|H|opioid medication(s). Other pain relievers (such as||
1239|101|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1239|102|H|or pharmacist about using morphine safely with other drugs.||
1239|103|H|   Suddenly stopping this medication may cause withdrawal,||
1239|104|H|especially if you have used it for a long time or in high doses.||
1239|105|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1239|106|H|Tell your doctor or pharmacist right away if you have any||
1239|107|H|withdrawal symptoms such as restlessness, mental/mood changes||
1239|108|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1239|109|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1239|110|H|aches, or sudden changes in behavior.||
1239|111|H|   When this medication is used for a long time, it may not work||
1239|112|H|as well. Talk with your doctor if this medication stops working||
1239|113|H|well.||
1239|114|H|   Though it helps many people, this medication may sometimes||
1239|115|H|cause addiction. This risk may be higher if you have a||
1239|116|H|mental/mood disorder or a substance use disorder (such as overuse||
1239|117|H|of or addiction to drugs/alcohol). Take this medication exactly||
1239|118|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1239|119|H|pharmacist for more details.||
1239|120|H|   Tell your doctor if your pain does not get better or if it||
1239|121|H|gets worse, or if you have any new pain.||
1239|122|B|||
1239|123|S|SIDE EFFECTS:  See also Warning section.||
1239|124|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
1239|125|S|drowsiness may occur. Some of these side effects may decrease||
1239|126|S|after you have been using this medication for a while. If any of||
1239|127|S|these effects last or get worse, tell your doctor or pharmacist||
1239|128|S|promptly.||
1239|129|S|   To prevent constipation, eat dietary fiber, drink enough||
1239|130|S|water, and exercise. You may also need to take a laxative. Ask||
1239|131|S|your pharmacist which type of laxative is right for you.||
1239|132|S|   To reduce the risk of dizziness and lightheadedness, get up||
1239|133|S|slowly when rising from a sitting or lying position.||
1239|134|S|   Remember that this medication has been prescribed because your||
1239|135|S|doctor has judged that the benefit to you is greater than the||
1239|136|S|risk of side effects. Many people using this medication do not||
1239|137|S|have serious side effects.||
1239|138|S|   Tell your doctor right away if you have any serious side||
1239|139|S|effects, including: interrupted breathing during sleep (sleep||
1239|140|S|apnea), mental/mood changes (such as agitation, confusion,||
1239|141|S|hallucinations), severe stomach/abdominal pain, difficulty||
1239|142|S|urinating, signs of your adrenal glands not working well (such as||
1239|143|S|loss of appetite, unusual tiredness, weight loss), trouble||
1239|144|S|swallowing.||
1239|145|S|   Get medical help right away if you have any very serious side||
1239|146|S|effects, including: fainting, seizure, slow/shallow breathing,||
1239|147|S|severe drowsiness/difficulty waking up.||
1239|148|S|   A very serious allergic reaction to this drug is rare.||
1239|149|S|However, get medical help right away if you notice any symptoms||
1239|150|S|of a serious allergic reaction, including: rash, itching/swelling||
1239|151|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1239|152|S|breathing.||
1239|153|S|   This is not a complete list of possible side effects. If you||
1239|154|S|notice other effects not listed above, contact your doctor or||
1239|155|S|pharmacist.||
1239|156|S|   In the US -||
1239|157|S|   Call your doctor for medical advice about side effects. You||
1239|158|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1239|159|S|www.fda.gov/medwatch.||
1239|160|S|   In Canada - Call your doctor for medical advice about side||
1239|161|S|effects. You may report side effects to Health Canada at||
1239|162|S|1-866-234-2345.||
1239|163|B|||
1239|164|P|PRECAUTIONS:  Before taking morphine, tell your doctor or||
1239|165|P|pharmacist if you are allergic to it; or to other opioid pain||
1239|166|P|medications (such as codeine); or if you have any other||
1239|167|P|allergies. This product may contain inactive ingredients, which||
1239|168|P|can cause allergic reactions or other problems. Talk to your||
1239|169|P|pharmacist for more details.||
1239|170|P|   Before using this medication, tell your doctor or pharmacist||
1239|171|P|your medical history, especially of: brain disorders (such as||
1239|172|P|head injury, tumor, seizures), breathing problems (such as||
1239|173|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1239|174|P|kidney disease, liver disease, mental/mood disorders (such as||
1239|175|P|confusion, depression), personal or family history of a substance||
1239|176|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
1239|177|P|stomach/intestinal problems (such as blockage, constipation,||
1239|178|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
1239|179|P|(such as due to enlarged prostate), disease of the pancreas||
1239|180|P|(pancreatitis), gallbladder disease.||
1239|181|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1239|182|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1239|183|P|machinery, or do anything that needs alertness until you can do||
1239|184|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1239|185|P|are using marijuana (cannabis).||
1239|186|P|   Before having surgery, tell your doctor or dentist about all||
1239|187|P|the products you use (including prescription drugs,||
1239|188|P|nonprescription drugs, and herbal products).||
1239|189|P|   Older adults may be more sensitive to the side effects of this||
1239|190|P|drug, especially confusion, dizziness, drowsiness, and||
1239|191|P|slow/shallow breathing.||
1239|192|P|   During pregnancy, this medication should be used only when||
1239|193|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1239|194|P|benefits with your doctor. (See also Warning section.)||
1239|195|P|   This drug passes into breast milk and may have undesirable||
1239|196|P|effects on a nursing infant. Tell the doctor right away if your||
1239|197|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1239|198|P|breathing. Consult your doctor before breastfeeding.||
1239|199|B|||
1239|200|I|DRUG INTERACTIONS:  See also Warning section.||
1239|201|I|   Drug interactions may change how your medications work or||
1239|202|I|increase your risk for serious side effects. This document does||
1239|203|I|not contain all possible drug interactions. Keep a list of all||
1239|204|I|the products you use (including prescription/nonprescription||
1239|205|I|drugs and herbal products) and share it with your doctor and||
1239|206|I|pharmacist. Do not start, stop, or change the dosage of any||
1239|207|I|medicines without your doctor's approval.||
1239|208|I|   Some products that may interact with this drug include:||
1239|209|I|certain pain medications (mixed opioid agonist-antagonists such||
1239|210|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1239|211|I|samidorphan.||
1239|212|I|   The risk of serious side effects (such as slow/shallow||
1239|213|I|breathing, severe drowsiness/dizziness) may be increased if this||
1239|214|I|medication is taken with other products that may also cause||
1239|215|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1239|216|I|if you are taking other products such as other opioid pain or||
1239|217|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1239|218|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1239|219|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1239|220|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1239|221|I|cetirizine, diphenhydramine).||
1239|222|I|   Check the labels on all your medicines (such as allergy or||
1239|223|I|cough-and-cold products) because they may contain ingredients||
1239|224|I|that cause drowsiness. Ask your pharmacist about using those||
1239|225|I|products safely.||
1239|226|I|   This medication may interfere with certain lab tests (such as||
1239|227|I|amylase/lipase levels), possibly causing false test results. Make||
1239|228|I|sure lab personnel and all your doctors know you use this drug.||
1239|229|B|||
1239|230|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1239|231|O|as passing out or trouble breathing, give them naloxone or||
1239|232|O|nalmefene if available, then call 911. If the person is awake and||
1239|233|O|has no symptoms, call a poison control center right away. US||
1239|234|O|residents can call 1-800-222-1222. Canada residents can call||
1239|235|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1239|236|O|breathing, slow heartbeat, coma.||
1239|237|B|||
1239|238|N|NOTES:  Do not share this medication with others. Sharing it is||
1239|239|N|against the law.||
1239|240|N|   This medication has been prescribed for your current condition||
1239|241|N|only. Do not use it later for another condition unless told to do||
1239|242|N|so by your doctor. A different medication may be necessary in||
1239|243|N|that case.||
1239|244|B|||
1239|245|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1239|246|D|remember. If it is near the time of the next dose, skip the||
1239|247|D|missed dose. Take your next dose at the regular time. Do not||
1239|248|D|double the dose to catch up.||
1239|249|B|||
1239|250|R|STORAGE:  Store at room temperature away from light and moisture.||
1239|251|R|Do not store in the bathroom. Keep all medications away from||
1239|252|R|children and pets. See also Warning section.||
1239|253|R|   Do not flush medications down the toilet or pour them into a||
1239|254|R|drain unless instructed to do so. Properly discard this product||
1239|255|R|when it is expired or no longer needed. For more details, read||
1239|256|R|the Medication Guide, or consult your pharmacist or local waste||
1239|257|R|disposal company.||
1239|258|B|||
1239|259|A|Information last revised August 2025.||
1239|260|A|Copyright(c) 2025 First Databank, Inc.||
1239|261|B|||
1240|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1240|002|Z|does NOT have all possible information about this product. This||
1240|003|Z|information does not assure that this product is safe, effective,||
1240|004|Z|or appropriate for you. This information is not individual||
1240|005|Z|medical advice and does not substitute for the advice of your||
1240|006|Z|health care professional. Always ask your health care||
1240|007|Z|professional for complete information about this product and your||
1240|008|Z|specific health needs.||
1240|009|B|||
1240|010|T|PENICILLIN G BENZATHINE/PENICILLIN G PROCAINE - INJECTION||
1240|011|F|(pen-ih-SILL-in G BEN-zuh-theen/pen-ih-SILL-in G PRO-cane)||
1240|012|B|||
1240|013|C|COMMON BRAND NAME(S): Bicillin C-R||
1240|014|B|||
1240|015|W|WARNING:  This medication must not be injected into a vein or||
1240|016|W|mixed with solutions that will be injected into a vein.||
1240|017|B|||
1240|018|U|USES:  This medication is used to treat a wide variety of||
1240|019|U|bacterial infections. This medication is known as a long-acting||
1240|020|U|natural penicillin antibiotic. It works by stopping the growth of||
1240|021|U|bacteria.||
1240|022|U|   This medication should not be used to treat sexually||
1240|023|U|transmitted diseases (such as syphilis, gonorrhea).||
1240|024|B|||
1240|025|H|HOW TO USE:  See also Warning section.||
1240|026|H|   This medication is given by injection into a large muscle as||
1240|027|H|directed by your doctor.||
1240|028|H|   The dosage is based on your medical condition and response to||
1240|029|H|treatment. Children's dosage is also based on weight.||
1240|030|H|   If you are giving this medication to yourself at home, learn||
1240|031|H|all preparation and usage instructions from your health care||
1240|032|H|professional. Before using, check this product for particles or||
1240|033|H|discoloration. If either is present, do not use the liquid. Learn||
1240|034|H|how to store and discard medical supplies safely.||
1240|035|H|   For the best effect, follow your doctor's directions for when||
1240|036|H|to receive this antibiotic, and make sure to not miss any doses.||
1240|037|H|   Continue to receive this medication until the full prescribed||
1240|038|H|amount is finished, even if symptoms disappear after a few days.||
1240|039|H|Stopping the medication too early may result in a return of the||
1240|040|H|infection.||
1240|041|H|   Tell your doctor if your condition lasts or gets worse.||
1240|042|B|||
1240|043|S|SIDE EFFECTS:  Pain at the injection site, nausea, or vomiting||
1240|044|S|may occur. If these effects last or get worse, tell your doctor||
1240|045|S|or pharmacist promptly.||
1240|046|S|   Remember that this medication has been prescribed because your||
1240|047|S|doctor has judged that the benefit to you is greater than the||
1240|048|S|risk of side effects. Many people using this medication do not||
1240|049|S|have serious side effects.||
1240|050|S|   Tell your doctor right away if you have any serious side||
1240|051|S|effects, including: severe pain/peeling skin at injection site,||
1240|052|S|joint/muscle pain, headache, vision changes, fast/slow/pounding||
1240|053|S|heartbeat, numbness/tingling of arms/legs, pain/redness/swelling||
1240|054|S|of arms/legs, change in skin color near injection site or on||
1240|055|S|arms/legs, uncontrolled movements, inability to move, signs of||
1240|056|S|kidney problems (such as change in the amount of urine), new||
1240|057|S|signs of infection (such as sore throat that doesn't go away,||
1240|058|S|fever, chills), easy bruising/bleeding, dark/cloudy urine,||
1240|059|S|seizures, mental/mood changes (such as depression, agitation).||
1240|060|S|   Get medical help right away if you have any very serious side||
1240|061|S|effects, including: chest pain, trouble speaking, fainting.||
1240|062|S|   This medication has rarely caused a very serious (possibly||
1240|063|S|fatal) blood disorder (methemoglobinemia). This effect is more||
1240|064|S|likely if you have breathing problems, certain diseases of the||
1240|065|S|blood, or if you smoke (see also Precautions section). The||
1240|066|S|symptoms of this disorder may occur within minutes to a couple of||
1240|067|S|hours after using this medication. Stop using this medication and||
1240|068|S|get medical help right away if you develop any symptoms of||
1240|069|S|methemoglobinemia, including: headache, confusion, dizziness,||
1240|070|S|shortness of breath, tiredness, pale/bluish/gray skin, fast||
1240|071|S|heartbeat.||
1240|072|S|   This medication may rarely cause a severe intestinal condition||
1240|073|S|due to a bacteria called C. difficile. This condition may occur||
1240|074|S|during treatment or weeks to months after treatment has stopped.||
1240|075|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1240|076|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1240|077|S|stool.||
1240|078|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1240|079|S|products because they may make symptoms worse.||
1240|080|S|   Use of this medication for prolonged or repeated periods may||
1240|081|S|result in oral thrush or a new vaginal yeast infection. Contact||
1240|082|S|your doctor if you notice white patches in your mouth, a change||
1240|083|S|in vaginal discharge, or other new symptoms.||
1240|084|S|   A very serious allergic reaction to this drug is rare.||
1240|085|S|However, get medical help right away if you notice any symptoms||
1240|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1240|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1240|088|S|breathing.||
1240|089|S|   This is not a complete list of possible side effects. If you||
1240|090|S|notice other effects not listed above, contact your doctor or||
1240|091|S|pharmacist.||
1240|092|S|   In the US -||
1240|093|S|   Call your doctor for medical advice about side effects. You||
1240|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1240|095|S|www.fda.gov/medwatch.||
1240|096|S|   In Canada - Call your doctor for medical advice about side||
1240|097|S|effects. You may report side effects to Health Canada at||
1240|098|S|1-866-234-2345.||
1240|099|B|||
1240|100|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1240|101|P|pharmacist if you are allergic to it; or to penicillin or||
1240|102|P|cephalosporin antibiotics; or to procaine; or if you have any||
1240|103|P|other allergies. This product may contain inactive ingredients,||
1240|104|P|which can cause allergic reactions or other problems. Talk to||
1240|105|P|your pharmacist for more details.||
1240|106|P|   Before using this medication, tell your doctor or pharmacist||
1240|107|P|your medical history, especially of: kidney disease, breathing||
1240|108|P|problems (such as asthma, bronchitis, emphysema, smoking||
1240|109|P|history), heart disease, certain blood disorders (G6PD||
1240|110|P|deficiency, pyruvate kinase deficiency, hemoglobin-M disease,||
1240|111|P|NADH-methemoglobin reductase deficiency).||
1240|112|P|   Penicillin may cause live bacterial vaccines (such as typhoid||
1240|113|P|vaccine) to not work well. Tell your health care professional||
1240|114|P|that you are using penicillin before having any||
1240|115|P|immunizations/vaccinations.||
1240|116|P|   Older adults may be at greater risk for side effects while||
1240|117|P|using this drug.||
1240|118|P|   Newborns/infants may be at greater risk for side effects while||
1240|119|P|using this drug.||
1240|120|P|   During pregnancy, this medication should be used only when||
1240|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
1240|122|P|   This drug passes into breast milk. Consult your doctor before||
1240|123|P|breastfeeding.||
1240|124|B|||
1240|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1240|126|I|medications work or increase your risk for serious side effects.||
1240|127|I|This document does not contain all possible drug interactions.||
1240|128|I|Keep a list of all the products you use (including||
1240|129|I|prescription/nonprescription drugs and herbal products) and share||
1240|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
1240|131|I|the dosage of any medicines without your doctor's approval.||
1240|132|I|   A product that may interact with this drug is: methotrexate.||
1240|133|I|   This medication may interfere with certain lab tests (such as||
1240|134|I|certain urine glucose tests), possibly causing false test||
1240|135|I|results. Make sure lab personnel and all your doctors know you||
1240|136|I|use this drug.||
1240|137|B|||
1240|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1240|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1240|140|O|poison control center right away. US residents can call||
1240|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1240|142|O|Symptoms of overdose may include: seizures, confusion,||
1240|143|O|mental/mood changes (such as agitation).||
1240|144|B|||
1240|145|N|NOTES:  Lab and/or medical tests (such as kidney function,||
1240|146|N|complete blood count) may be done while you are using this||
1240|147|N|medication. Keep all medical and lab appointments. Consult your||
1240|148|N|doctor for more details.||
1240|149|B|||
1240|150|D|MISSED DOSE:  It is important to get each dose of this medication||
1240|151|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1240|152|D|right away for a new dosing schedule. Do not double the dose to||
1240|153|D|catch up.||
1240|154|B|||
1240|155|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
1240|156|R|medications away from children and pets.||
1240|157|R|   Do not flush medications down the toilet or pour them into a||
1240|158|R|drain unless instructed to do so. Properly discard this product||
1240|159|R|when it is expired or no longer needed. Consult your pharmacist||
1240|160|R|or local waste disposal company.||
1240|161|B|||
1240|162|A|Information last revised April 2025.||
1240|163|A|Copyright(c) 2025 First Databank, Inc.||
1240|164|B|||
1241|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1241|002|Z|does NOT have all possible information about this product. This||
1241|003|Z|information does not assure that this product is safe, effective,||
1241|004|Z|or appropriate for you. This information is not individual||
1241|005|Z|medical advice and does not substitute for the advice of your||
1241|006|Z|health care professional. Always ask your health care||
1241|007|Z|professional for complete information about this product and your||
1241|008|Z|specific health needs.||
1241|009|B|||
1241|010|T|ETODOLAC SUSTAINED-ACTION - ORAL||
1241|011|F|(EE-to-DOE-lak)||
1241|012|B|||
1241|013|C|COMMON BRAND NAME(S): Lodine XL||
1241|014|B|||
1241|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1241|016|W|etodolac) may rarely increase the risk of a heart attack or||
1241|017|W|stroke. This effect can happen at any time while taking this drug||
1241|018|W|but is more likely if you take it for a long time. The risk may||
1241|019|W|be greater in older adults or if you have heart disease or||
1241|020|W|increased risk for heart disease (for example, due to smoking,||
1241|021|W|family history of heart disease, or conditions such as high blood||
1241|022|W|pressure or diabetes). Do not take this drug right before or||
1241|023|W|after heart bypass surgery (CABG).||
1241|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
1241|025|W|bleeding from the stomach or intestines. This effect can occur||
1241|026|W|without warning symptoms at any time while taking this drug.||
1241|027|W|Older adults may be at higher risk for this effect.||
1241|028|W|   Stop taking etodolac and get medical help right away if you||
1241|029|W|notice any of these rare but serious side effects:||
1241|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
1241|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1241|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
1241|033|W|side of the body, trouble speaking, sudden vision changes.||
1241|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
1241|035|W|of taking this drug.||
1241|036|B|||
1241|037|U|USES:  See also Warning section.||
1241|038|U|   The sustained-action tablet form of etodolac is used to reduce||
1241|039|U|pain, swelling, and joint stiffness from arthritis. Reducing||
1241|040|U|symptoms of arthritis may improve your ability to move/exercise,||
1241|041|U|work, and perform tasks normally.||
1241|042|U|   Etodolac is known as a nonsteroidal anti-inflammatory drug||
1241|043|U|(NSAID). It works by blocking your body's production of certain||
1241|044|U|natural substances that cause inflammation.||
1241|045|U|   Ask your doctor about non-drug treatments and/or using other||
1241|046|U|medications to treat your pain.||
1241|047|B|||
1241|048|V|OTHER USES:  This section contains uses of this drug that are not||
1241|049|V|listed in the approved professional labeling for the drug but||
1241|050|V|that may be prescribed by your health care professional. Use this||
1241|051|V|drug for a condition that is listed in this section only if it||
1241|052|V|has been so prescribed by your health care professional.||
1241|053|V|   This medication may also be used for gout attacks.||
1241|054|B|||
1241|055|H|HOW TO USE:  Read the Medication Guide provided by your||
1241|056|H|pharmacist before you start taking etodolac and each time you get||
1241|057|H|a refill. If you have any questions, ask your doctor or||
1241|058|H|pharmacist.||
1241|059|H|   Take this medication by mouth as directed by your doctor,||
1241|060|H|usually once daily. Take this medication with a full glass of||
1241|061|H|water (8 ounces/240 milliliters) unless your doctor directs you||
1241|062|H|otherwise. Do not lie down for at least 10 minutes after taking||
1241|063|H|this medication. If stomach upset occurs while taking this||
1241|064|H|medication, take it with food, milk, or an antacid.||
1241|065|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1241|066|H|Doing so can release all of the drug at once, increasing the risk||
1241|067|H|of side effects.||
1241|068|H|   The dosage is based on your medical condition and response to||
1241|069|H|treatment. To reduce your risk of stomach bleeding and other side||
1241|070|H|effects, take this medication at the lowest effective dose for||
1241|071|H|the shortest possible time. Do not increase your dose or use this||
1241|072|H|drug more often or for longer than prescribed. Discuss the risks||
1241|073|H|and benefits with your doctor or pharmacist.||
1241|074|H|   It may take up to 2 weeks of taking this drug regularly until||
1241|075|H|you get the full benefit.||
1241|076|H|   Tell your doctor if your condition gets worse.||
1241|077|B|||
1241|078|S|SIDE EFFECTS:  See also Warning section.||
1241|079|S|   Upset stomach, nausea, diarrhea, gas, weakness, drowsiness,||
1241|080|S|dizziness, or blurred vision may occur. If any of these effects||
1241|081|S|last or get worse, tell your doctor or pharmacist promptly.||
1241|082|S|   Remember that this medication has been prescribed because your||
1241|083|S|doctor has judged that the benefit to you is greater than the||
1241|084|S|risk of side effects. Many people using this medication do not||
1241|085|S|have serious side effects.||
1241|086|S|   This medication may raise your blood pressure. Check your||
1241|087|S|blood pressure regularly and tell your doctor if the results are||
1241|088|S|high.||
1241|089|S|   Tell your doctor right away if you have any serious side||
1241|090|S|effects, including: hearing changes (such as ringing in the||
1241|091|S|ears), mental/mood changes, easy bleeding/bruising,||
1241|092|S|difficult/painful swallowing, signs of kidney problems (such as||
1241|093|S|change in the amount of urine, pink/bloody urine), symptoms of||
1241|094|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
1241|095|S|unusual/sudden weight gain).||
1241|096|S|   Etodolac may rarely cause serious (possibly fatal) liver||
1241|097|S|disease. Get medical help right away if you have any symptoms of||
1241|098|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1241|099|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1241|100|S|urine.||
1241|101|S|   A very serious allergic reaction to this drug is rare.||
1241|102|S|However, get medical help right away if you notice any symptoms||
1241|103|S|of a serious allergic reaction, including: fever, swollen lymph||
1241|104|S|nodes, rash, itching/swelling (especially of the||
1241|105|S|face/tongue/throat), severe dizziness, trouble breathing.||
1241|106|S|   This is not a complete list of possible side effects. If you||
1241|107|S|notice other effects not listed above, contact your doctor or||
1241|108|S|pharmacist.||
1241|109|S|   In the US -||
1241|110|S|   Call your doctor for medical advice about side effects. You||
1241|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1241|112|S|www.fda.gov/medwatch.||
1241|113|S|   In Canada - Call your doctor for medical advice about side||
1241|114|S|effects. You may report side effects to Health Canada at||
1241|115|S|1-866-234-2345.||
1241|116|B|||
1241|117|P|PRECAUTIONS:  See also Warning section.||
1241|118|P|   Before taking etodolac, tell your doctor or pharmacist if you||
1241|119|P|are allergic to it; or to aspirin or other NSAIDs (such as||
1241|120|P|ibuprofen, naproxen, celecoxib); or if you have any other||
1241|121|P|allergies. This product may contain inactive ingredients, which||
1241|122|P|can cause allergic reactions or other problems. Talk to your||
1241|123|P|pharmacist for more details.||
1241|124|P|   Before taking this medication, tell your doctor or pharmacist||
1241|125|P|your medical history, especially of: asthma (including a history||
1241|126|P|of worsening breathing after taking aspirin or other NSAIDs),||
1241|127|P|blood disorders (such as anemia, bleeding/clotting problems),||
1241|128|P|growths in the nose (nasal polyps), heart disease (such as||
1241|129|P|previous heart attack), high blood pressure, liver disease,||
1241|130|P|stroke, swelling (edema, fluid retention),||
1241|131|P|stomach/intestinal/esophagus problems (such as bleeding,||
1241|132|P|heartburn, ulcers).||
1241|133|P|   Kidney problems can sometimes occur with the use of NSAID||
1241|134|P|medications, including etodolac. Problems are more likely to||
1241|135|P|occur if you are dehydrated, have heart failure or kidney||
1241|136|P|disease, are an older adult, or if you take certain medications||
1241|137|P|(see also Drug Interactions section). Drink plenty of fluids as||
1241|138|P|directed by your doctor to prevent dehydration and tell your||
1241|139|P|doctor right away if you have pink/bloody urine or any unusual||
1241|140|P|change in the amount of urine.||
1241|141|P|   This drug may make you dizzy or drowsy or cause blurred||
1241|142|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
1241|143|P|Do not drive, use machinery, or do anything that needs alertness||
1241|144|P|or clear vision until you can do it safely. Limit alcoholic||
1241|145|P|beverages. Talk to your doctor if you are using marijuana||
1241|146|P|(cannabis).||
1241|147|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1241|148|P|and tobacco, especially when combined with this medicine, may||
1241|149|P|increase your risk for stomach bleeding. Limit alcohol and stop||
1241|150|P|smoking.||
1241|151|P|   This medication may make you more sensitive to the sun. Limit||
1241|152|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1241|153|P|sunscreen and wear protective clothing when outdoors. Tell your||
1241|154|P|doctor right away if you get sunburned or have skin||
1241|155|P|blisters/redness.||
1241|156|P|   Before having surgery, tell your doctor or dentist about all||
1241|157|P|the products you use (including prescription drugs,||
1241|158|P|nonprescription drugs, and herbal products).||
1241|159|P|   Older adults may be at greater risk for stomach/intestinal||
1241|160|P|bleeding, kidney problems, heart attack, and stroke while using||
1241|161|P|this drug.||
1241|162|P|   Before using this medication, women of childbearing age should||
1241|163|P|talk with their doctor(s) about the benefits and risks. Tell your||
1241|164|P|doctor if you are pregnant or if you plan to become pregnant.||
1241|165|P|This medication may harm an unborn baby and cause problems with||
1241|166|P|normal labor/delivery. It is not recommended for use in pregnancy||
1241|167|P|from 20 weeks until delivery. If your doctor decides that you||
1241|168|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1241|169|P|you should use the lowest effective dose for the shortest||
1241|170|P|possible time. You should not use this medication after 30 weeks||
1241|171|P|of pregnancy.||
1241|172|P|   It is unknown if this medication passes into breast milk.||
1241|173|P|Consult your doctor before breastfeeding.||
1241|174|B|||
1241|175|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1241|176|I|medications work or increase your risk for serious side effects.||
1241|177|I|This document does not contain all possible drug interactions.||
1241|178|I|Keep a list of all the products you use (including||
1241|179|I|prescription/nonprescription drugs and herbal products) and share||
1241|180|I|it with your doctor and pharmacist. Do not start, stop, or change||
1241|181|I|the dosage of any medicines without your doctor's approval.||
1241|182|I|   Some products that may interact with this drug are: aliskiren,||
1241|183|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
1241|184|I|receptor blockers (such as losartan, valsartan), cidofovir,||
1241|185|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
1241|186|I|methotrexate, "water pills" (diuretics such as furosemide).||
1241|187|I|   This medication may increase the risk of bleeding when taken||
1241|188|I|with other drugs that also may cause bleeding. Examples include||
1241|189|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1241|190|I|dabigatran/enoxaparin/warfarin, among others.||
1241|191|I|   Check all prescription and nonprescription medicine labels||
1241|192|I|carefully since many medications contain pain relievers/fever||
1241|193|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
1241|194|I|naproxen). These drugs are similar to etodolac and may increase||
1241|195|I|your risk of side effects if taken together. However, if your||
1241|196|I|doctor has told you to take low-dose aspirin to prevent heart||
1241|197|I|attack or stroke (usually 81-162 milligrams a day), you should||
1241|198|I|keep taking the aspirin unless your doctor tells you not to. Ask||
1241|199|I|your doctor or pharmacist for more details.||
1241|200|I|   This medication may interfere with certain lab tests, possibly||
1241|201|I|causing false test results. Make sure lab personnel and all your||
1241|202|I|doctors know you use this drug.||
1241|203|B|||
1241|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1241|205|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1241|206|O|poison control center right away. US residents can call||
1241|207|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1241|208|O|Symptoms of overdose may include: severe stomach pain,||
1241|209|O|slow/shallow breathing, extreme drowsiness.||
1241|210|B|||
1241|211|N|NOTES:  Do not share this medication with others.||
1241|212|N|   Lab and/or medical tests (such as complete blood count,||
1241|213|N|liver/kidney function, blood pressure) may be done while you are||
1241|214|N|using this medication. Keep all medical and lab appointments.||
1241|215|N|Consult your doctor for more details.||
1241|216|N|   Lifestyle changes (such as weight loss if needed,||
1241|217|N|strengthening/conditioning exercises) may help improve your||
1241|218|N|flexibility and joint function. Consult your doctor for specific||
1241|219|N|instructions.||
1241|220|B|||
1241|221|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1241|222|D|remember. If it is near the time of the next dose, skip the||
1241|223|D|missed dose. Take your next dose at the regular time. Do not||
1241|224|D|double the dose to catch up.||
1241|225|B|||
1241|226|R|STORAGE:  Store at room temperature away from light and moisture.||
1241|227|R|Do not store in the bathroom. Keep all medications away from||
1241|228|R|children and pets.||
1241|229|R|   Do not flush medications down the toilet or pour them into a||
1241|230|R|drain unless instructed to do so. Properly discard this product||
1241|231|R|when it is expired or no longer needed. Consult your pharmacist||
1241|232|R|or local waste disposal company.||
1241|233|B|||
1241|234|A|Information last revised May 2024.||
1241|235|A|Copyright(c) 2025 First Databank, Inc.||
1241|236|B|||
1242|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1242|002|Z|does NOT have all possible information about this product. This||
1242|003|Z|information does not assure that this product is safe, effective,||
1242|004|Z|or appropriate for you. This information is not individual||
1242|005|Z|medical advice and does not substitute for the advice of your||
1242|006|Z|health care professional. Always ask your health care||
1242|007|Z|professional for complete information about this product and your||
1242|008|Z|specific health needs.||
1242|009|B|||
1242|010|T|CANAKINUMAB - INJECTION||
1242|011|F|(KAN-a-KIN-ue-mab)||
1242|012|B|||
1242|013|C|COMMON BRAND NAME(S): Ilaris||
1242|014|B|||
1242|015|U|USES:  This medication is used to treat certain types of periodic||
1242|016|U|fever syndromes, which include cryopyrin-associated periodic||
1242|017|U|syndromes (CAPS), tumor necrosis factor receptor associated||
1242|018|U|periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome||
1242|019|U|(HIDS)/mevalonate kinase deficiency (MKD), and familial||
1242|020|U|Mediterranean fever (FMF). Canakinumab works by blocking a||
1242|021|U|certain natural protein in your body (interleukin-1 beta) that||
1242|022|U|may worsen the symptoms of these diseases. Canakinumab may help||
1242|023|U|to lessen the symptoms, such as rash, joint/muscle pain, fever,||
1242|024|U|eye redness, and tiredness.||
1242|025|U|   Canakinumab is also used to treat gout attacks (flares),||
1242|026|U|Still's disease, and a type of arthritis in children (systemic||
1242|027|U|juvenile idiopathic arthritis-SJIA).||
1242|028|B|||
1242|029|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1242|030|H|Patient Information Leaflet provided by your pharmacist before||
1242|031|H|you start using canakinumab and each time you get a refill. If||
1242|032|H|you have any questions, ask your doctor or pharmacist.||
1242|033|H|   This medication is injected under the skin as directed by your||
1242|034|H|doctor. The dosage and treatment schedule are based on your||
1242|035|H|medical condition, weight, and response to treatment.||
1242|036|H|   If you are using this medication at home, learn all||
1242|037|H|preparation and usage instructions from your health care||
1242|038|H|professional. Do not shake the vial. Before using, check this||
1242|039|H|product for particles or discoloration. If either is present, do||
1242|040|H|not use the liquid. Before injecting each dose, clean the skin||
1242|041|H|you are going to inject into (the injection site) with rubbing||
1242|042|H|alcohol. Change the injection site each time to lessen injury||
1242|043|H|under the skin. Do not inject into skin that is tender, red, or||
1242|044|H|hard. To lessen bruising, do not rub the injection site after a||
1242|045|H|shot. Learn how to store and discard medical supplies safely.||
1242|046|H|   Use this medication regularly to get the most benefit from it.||
1242|047|H|To help you remember, mark your calendar with a reminder.||
1242|048|H|   Tell your doctor if your condition does not get better or if||
1242|049|H|it gets worse.||
1242|050|B|||
1242|051|S|SIDE EFFECTS:  Redness, itching, pain, warmth, or swelling at the||
1242|052|S|injection site may occur. Dizziness, nausea, diarrhea, or||
1242|053|S|headache may also occur. If any of these effects last or get||
1242|054|S|worse, tell your doctor or pharmacist promptly.||
1242|055|S|   Remember that this medication has been prescribed because your||
1242|056|S|doctor has judged that the benefit to you is greater than the||
1242|057|S|risk of side effects. Many people using this medication do not||
1242|058|S|have serious side effects.||
1242|059|S|   This medication can affect your immune system. It can lower||
1242|060|S|your body's ability to fight an infection. You may be more likely||
1242|061|S|to get serious infections, such as pneumonia, bone/joint||
1242|062|S|infections, skin infections, or sinusitis. It may also be harder||
1242|063|S|to fight an infection you already have. Get medical help right||
1242|064|S|away if you have any signs of infection (such as sore throat that||
1242|065|S|doesn't go away, fever, swollen lymph nodes, chills, cough).||
1242|066|S|   A very serious allergic reaction to this drug is rare.||
1242|067|S|However, get medical help right away if you notice any symptoms||
1242|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1242|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1242|070|S|breathing.||
1242|071|S|   This is not a complete list of possible side effects. If you||
1242|072|S|notice other effects not listed above, contact your doctor or||
1242|073|S|pharmacist.||
1242|074|S|   In the US -||
1242|075|S|   Call your doctor for medical advice about side effects. You||
1242|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1242|077|S|www.fda.gov/medwatch.||
1242|078|S|   In Canada - Call your doctor for medical advice about side||
1242|079|S|effects. You may report side effects to Health Canada at||
1242|080|S|1-866-234-2345.||
1242|081|B|||
1242|082|P|PRECAUTIONS:  Before using canakinumab, tell your doctor or||
1242|083|P|pharmacist if you are allergic to it; or if you have any other||
1242|084|P|allergies. This product may contain inactive ingredients, which||
1242|085|P|can cause allergic reactions or other problems. Talk to your||
1242|086|P|pharmacist for more details.||
1242|087|P|   Before using this medication, tell your doctor or pharmacist||
1242|088|P|your medical history, especially of: immune system problems (such||
1242|089|P|as HIV infection), current/recent/returning infection (including||
1242|090|P|hepatitis and tuberculosis), cancer.||
1242|091|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1242|092|P|can make you more dizzy. Do not drive, use machinery, or do||
1242|093|P|anything that needs alertness until you can do it safely. Limit||
1242|094|P|alcoholic beverages. Talk to your doctor if you are using||
1242|095|P|marijuana (cannabis).||
1242|096|P|   Before starting this drug, you should take a tuberculosis (TB)||
1242|097|P|skin test to check for a type of tuberculosis that may not be||
1242|098|P|causing any symptoms (latent TB). If you are diagnosed with TB,||
1242|099|P|you must first be treated for it before you start canakinumab to||
1242|100|P|prevent a serious TB infection.||
1242|101|P|   Canakinumab can make you more likely to get infections or may||
1242|102|P|make current infections worse. Stay away from anyone who has an||
1242|103|P|infection that may easily spread (such as chickenpox, COVID-19,||
1242|104|P|measles, flu). Talk to your doctor if you have been exposed to an||
1242|105|P|infection or for more details.||
1242|106|P|   Tell your health care professional that you are using||
1242|107|P|canakinumab before having any immunizations/vaccinations. Avoid||
1242|108|P|contact with people who have recently received live vaccines||
1242|109|P|(such as flu vaccine inhaled through the nose).||
1242|110|P|   During pregnancy, this medication should be used only when||
1242|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
1242|112|P|   It is unknown if this drug passes into breast milk. Consult||
1242|113|P|your doctor before breastfeeding.||
1242|114|B|||
1242|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1242|116|I|medications work or increase your risk for serious side effects.||
1242|117|I|This document does not contain all possible drug interactions.||
1242|118|I|Keep a list of all the products you use (including||
1242|119|I|prescription/nonprescription drugs and herbal products) and share||
1242|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1242|121|I|the dosage of any medicines without your doctor's approval.||
1242|122|I|   Some products that may interact with this drug include: other||
1242|123|I|IL-1 blockers (such as anakinra, rilonacept), TNF-blockers (such||
1242|124|I|as adalimumab, etanercept, infliximab).||
1242|125|B|||
1242|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1242|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1242|128|O|poison control center right away. US residents can call||
1242|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1242|130|B|||
1242|131|N|NOTES:  Do not share this medication with others.||
1242|132|N|   Lab and/or medical tests (such as complete blood count, liver||
1242|133|N|function) should be done while you are using this medication.||
1242|134|N|Keep all medical and lab appointments. Consult your doctor for||
1242|135|N|more details.||
1242|136|B|||
1242|137|D|MISSED DOSE:  It is important to get each dose of this medication||
1242|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1242|139|D|right away for a new dosing schedule. Do not double the dose to||
1242|140|D|catch up.||
1242|141|B|||
1242|142|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1242|143|R|medication in the original carton to protect from light. Each||
1242|144|R|vial of medication is for single use only. Discard any unused||
1242|145|R|portion. Keep all medications away from children and pets.||
1242|146|R|   Do not flush medications down the toilet or pour them into a||
1242|147|R|drain unless instructed to do so. Properly discard this product||
1242|148|R|when it is expired or no longer needed. Consult your pharmacist||
1242|149|R|or local waste disposal company.||
1242|150|B|||
1242|151|M|MEDICAL ALERT:  Your condition can cause complications in a||
1242|152|M|medical emergency. For information about enrolling in MedicAlert,||
1242|153|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1242|154|B|||
1242|155|A|Information last revised April 2025.||
1242|156|A|Copyright(c) 2025 First Databank, Inc.||
1242|157|B|||
1244|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1244|002|Z|does NOT have all possible information about this product. This||
1244|003|Z|information does not assure that this product is safe, effective,||
1244|004|Z|or appropriate for you. This information is not individual||
1244|005|Z|medical advice and does not substitute for the advice of your||
1244|006|Z|health care professional. Always ask your health care||
1244|007|Z|professional for complete information about this product and your||
1244|008|Z|specific health needs.||
1244|009|B|||
1244|010|T|MIDAZOLAM - ORAL SYRUP||
1244|011|F|(mid-AZE-oh-lam)||
1244|012|B|||
1244|013|C|COMMON BRAND NAME(S): Versed||
1244|014|B|||
1244|015|W|WARNING:  Midazolam has a risk for abuse and addiction, which can||
1244|016|W|lead to overdose and death. Taking this medication with alcohol||
1244|017|W|or other drugs that can cause drowsiness or breathing problems||
1244|018|W|(especially opioid medications such as codeine, hydrocodone) may||
1244|019|W|cause very serious side effects, including death. To lower your||
1244|020|W|risk, your doctor should have you take the smallest dose of||
1244|021|W|midazolam that works, and take it for the shortest possible time.||
1244|022|W|Be sure you know how to take midazolam and what other drugs you||
1244|023|W|should avoid taking with it. See also Drug Interactions section.||
1244|024|W|Get medical help right away if any of these very serious side||
1244|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
1244|026|W|severe drowsiness/dizziness, difficulty waking up.||
1244|027|W|   Suddenly stopping this medication may cause serious (possibly||
1244|028|W|fatal) withdrawal, especially if you have used it for a long time||
1244|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
1244|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
1244|031|W|you have any withdrawal symptoms such as headaches, trouble||
1244|032|W|sleeping, restlessness, hallucinations/confusion, depression,||
1244|033|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
1244|034|W|to months.||
1244|035|B|||
1244|036|U|USES:  This medication is used by children before a procedure or||
1244|037|U|anesthesia to cause drowsiness, decrease anxiety, and cause||
1244|038|U|forgetfulness of the surgery or procedure. It should be used||
1244|039|U|while the child is under the care of a health professional. It is||
1244|040|U|not for home or long-term use.||
1244|041|U|   Midazolam belongs to a class of medications called||
1244|042|U|benzodiazepines, which produce a calming effect on the brain and||
1244|043|U|nerves (central nervous system). It is thought to work by||
1244|044|U|increasing the effect of a certain natural chemical (GABA) in the||
1244|045|U|brain.||
1244|046|B|||
1244|047|V|OTHER USES:  This section contains uses of this drug that are not||
1244|048|V|listed in the approved professional labeling for the drug but||
1244|049|V|that may be prescribed by your health care professional. Use this||
1244|050|V|drug for a condition that is listed in this section only if it||
1244|051|V|has been so prescribed by your health care professional.||
1244|052|V|   This drug may also be used short-term for sleep problems (such||
1244|053|V|as trouble sleeping, "night terrors").||
1244|054|B|||
1244|055|H|HOW TO USE:  See also Warning section.||
1244|056|H|   A healthcare professional will prepare and measure your dose.||
1244|057|H|Take this medication by mouth as directed by your doctor. It is||
1244|058|H|usually given as a single dose before a procedure or anesthesia.||
1244|059|H|   The dosage is based on your medical condition, response to||
1244|060|H|treatment, weight, and other medications you may be taking.||
1244|061|H|   Though it helps many people, this medication may sometimes||
1244|062|H|cause addiction. This risk may be higher if you have a substance||
1244|063|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1244|064|H|Do not increase your dose, take it more often, or use it for a||
1244|065|H|longer time than prescribed. Talk with the doctor if this||
1244|066|H|medication stops working well. Properly stop the medication when||
1244|067|H|so directed.||
1244|068|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1244|069|H|using this medication unless your doctor or pharmacist says you||
1244|070|H|may do so safely. Grapefruit can increase the chance of side||
1244|071|H|effects with this medicine. Ask your doctor or pharmacist for||
1244|072|H|more details.||
1244|073|B|||
1244|074|S|SIDE EFFECTS:  See also Warning section.||
1244|075|S|   Nausea, vomiting, dizziness, or drowsiness may occur. If any||
1244|076|S|of these effects last or get worse, notify the doctor or||
1244|077|S|pharmacist promptly.||
1244|078|S|   Remember that this medication has been prescribed because your||
1244|079|S|doctor has judged that the benefit to you is greater than the||
1244|080|S|risk of side effects. Many people using this medication do not||
1244|081|S|have serious side effects.||
1244|082|S|   Tell your doctor right away if you have any serious side||
1244|083|S|effects, including: mental/mood changes (such as agitation,||
1244|084|S|aggressive behavior), uncontrollable movements (such as||
1244|085|S|shaking/tremor), slow/fast heartbeat, vision changes (such as||
1244|086|S|blurred vision).||
1244|087|S|   Get medical help right away if you have any very serious side||
1244|088|S|effects, including: fainting, rapid/slow/shallow breathing.||
1244|089|S|   A very serious allergic reaction to this drug is rare.||
1244|090|S|However, get medical help right away if you notice any symptoms||
1244|091|S|of a serious allergic reaction, including: rash, itching/swelling||
1244|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1244|093|S|breathing.||
1244|094|S|   This is not a complete list of possible side effects. If you||
1244|095|S|notice other effects not listed above, contact the doctor or||
1244|096|S|pharmacist.||
1244|097|S|   In the US -||
1244|098|S|   Call your doctor for medical advice about side effects. You||
1244|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1244|100|S|www.fda.gov/medwatch.||
1244|101|S|   In Canada - Call your doctor for medical advice about side||
1244|102|S|effects. You may report side effects to Health Canada at||
1244|103|S|1-866-234-2345.||
1244|104|B|||
1244|105|P|PRECAUTIONS:  Before taking midazolam, tell the doctor or||
1244|106|P|pharmacist if you are allergic to it; or to other benzodiazepines||
1244|107|P|(such as diazepam); or if you have any other allergies. This||
1244|108|P|product may contain inactive ingredients (such as cherry||
1244|109|P|flavoring), which can cause allergic reactions or other problems.||
1244|110|P|Talk to your pharmacist for more details.||
1244|111|P|   Before using this medication, tell the doctor or pharmacist||
1244|112|P|your medical history, especially of: kidney disease, liver||
1244|113|P|disease, breathing problems (such as chronic obstructive||
1244|114|P|pulmonary disease-COPD, sleep apnea), heart disease (such as||
1244|115|P|heart failure), glaucoma, personal or family history of a||
1244|116|P|substance use disorder (such as overuse of or addiction to||
1244|117|P|drugs/alcohol).||
1244|118|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1244|119|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1244|120|P|machinery, or do anything that needs alertness until you can do||
1244|121|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1244|122|P|are using marijuana (cannabis).||
1244|123|P|   Before having surgery, tell your doctor or dentist about all||
1244|124|P|the products you use (including prescription drugs,||
1244|125|P|nonprescription drugs, and herbal products).||
1244|126|P|   Infants and children younger than 3 years using anesthesia or||
1244|127|P|drugs for sedation (including midazolam) for procedures/surgeries||
1244|128|P|may be at risk for slower brain growth. Talk to the doctor about||
1244|129|P|the risks and benefits of this medication.||
1244|130|P|   Tell your doctor if you are pregnant or plan to become||
1244|131|P|pregnant. You should not become pregnant while using midazolam.||
1244|132|P|Midazolam may harm an unborn baby. Newborn babies of mothers who||
1244|133|P|use this medication late in pregnancy may have symptoms such as||
1244|134|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
1244|135|P|feeding. If you become pregnant, talk to your doctor right away||
1244|136|P|about the risks and benefits of this medication.||
1244|137|P|   This medication passes into breast milk. Consult your doctor||
1244|138|P|before breastfeeding.||
1244|139|B|||
1244|140|I|DRUG INTERACTIONS:  See also Warning section.||
1244|141|I|   Drug interactions may change how your medications work or||
1244|142|I|increase your risk for serious side effects. This document does||
1244|143|I|not contain all possible drug interactions. Keep a list of all||
1244|144|I|the products you use (including prescription/nonprescription||
1244|145|I|drugs and herbal products) and share it with your doctor and||
1244|146|I|pharmacist. Do not start, stop, or change the dosage of any||
1244|147|I|medicines without your doctor's approval.||
1244|148|I|   Some products that may interact with this drug include: HIV||
1244|149|I|protease inhibitors (such as atazanavir), lonafarnib, sodium||
1244|150|I|oxybate, ritonavir.||
1244|151|I|   Other medications can affect the removal of midazolam from||
1244|152|I|your body, which may affect how midazolam works. Examples include||
1244|153|I|azole antifungals (such as itraconazole, ketoconazole), macrolide||
1244|154|I|antibiotics (such as erythromycin), cimetidine, rifamycins (such||
1244|155|I|as rifabutin, rifampin), St. John's wort, certain anti-seizure||
1244|156|I|medicines (such as carbamazepine, phenytoin), calcium channel||
1244|157|I|blockers (such as diltiazem, verapamil), certain SSRIs (such as||
1244|158|I|fluoxetine, fluvoxamine), nefazodone, conivaptan, among others.||
1244|159|I|   The risk of serious side effects (such as slow/shallow||
1244|160|I|breathing, severe drowsiness/dizziness) may be increased if this||
1244|161|I|medication is taken with other products that may also cause||
1244|162|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1244|163|I|if you are taking other products such as opioid pain or cough||
1244|164|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1244|165|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1244|166|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1244|167|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1244|168|I|diphenhydramine).||
1244|169|I|   Check the labels on all your medicines (such as allergy or||
1244|170|I|cough-and-cold products) because they may contain ingredients||
1244|171|I|that cause drowsiness. Ask your pharmacist about using those||
1244|172|I|products safely.||
1244|173|B|||
1244|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1244|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1244|176|O|poison control center right away. US residents can call||
1244|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1244|178|O|Symptoms of overdose may include: drowsiness, confusion, loss of||
1244|179|O|coordination.||
1244|180|B|||
1244|181|N|NOTES:  Do not share this medication with others. Sharing it is||
1244|182|N|against the law.||
1244|183|N|   This medication has been prescribed for your current procedure||
1244|184|N|only. Do not use it later for another condition or procedure||
1244|185|N|unless told to do so by the doctor. A different medication may be||
1244|186|N|necessary in that case.||
1244|187|N|   Lab and/or medical tests (such as breathing, blood pressure,||
1244|188|N|heartbeat) should be done while you are taking this medication.||
1244|189|N|Keep all medical and lab appointments. Consult your doctor for||
1244|190|N|more details.||
1244|191|B|||
1244|192|D|MISSED DOSE:  Not applicable.||
1244|193|B|||
1244|194|R|STORAGE:  Not applicable. This medication is given in a hospital,||
1244|195|R|clinic, or doctor's office and will not be stored at home.||
1244|196|B|||
1244|197|A|Information last revised July 2024.||
1244|198|A|Copyright(c) 2025 First Databank, Inc.||
1244|199|B|||
1249|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1249|002|Z|does NOT have all possible information about this product. This||
1249|003|Z|information does not assure that this product is safe, effective,||
1249|004|Z|or appropriate for you. This information is not individual||
1249|005|Z|medical advice and does not substitute for the advice of your||
1249|006|Z|health care professional. Always ask your health care||
1249|007|Z|professional for complete information about this product and your||
1249|008|Z|specific health needs.||
1249|009|B|||
1249|010|T|CYANOCOBALAMIN - ORAL||
1249|011|F|(SYE-an-oh-koe-BAL-a-min)||
1249|012|B|||
1249|013|C|COMMON BRAND NAME(S): Vitamin B-12||
1249|014|B|||
1249|015|U|USES:  See also Precautions section.||
1249|016|U|   Cyanocobalamin is a man-made form of vitamin B12 used to||
1249|017|U|prevent and treat low blood levels of this vitamin. Most people||
1249|018|U|get enough vitamin B12 from their diet. Vitamin B12 is important||
1249|019|U|to maintain the health of your metabolism, blood cells, and||
1249|020|U|nerves. Serious vitamin B12 deficiency may result in a low number||
1249|021|U|of red blood cells (anemia), stomach/intestine problems, and||
1249|022|U|permanent nerve damage.||
1249|023|U|   Vitamin B12 deficiency may occur in certain health conditions||
1249|024|U|(such as intestinal/stomach problems, poor nutrition, cancer, HIV||
1249|025|U|infection, pregnancy, old age, alcoholism). It may also occur in||
1249|026|U|people who follow a strict vegetarian (vegan) diet.||
1249|027|B|||
1249|028|H|HOW TO USE:  If you are taking the over-the-counter product to||
1249|029|H|self-treat, follow all directions on the product package before||
1249|030|H|taking this medication. If you have any questions, consult your||
1249|031|H|pharmacist. If your doctor has directed you to take this||
1249|032|H|medication, take as directed by your doctor.||
1249|033|H|   Take this medication by mouth with or without food as directed||
1249|034|H|by your doctor or the product package, usually once daily. Use||
1249|035|H|this product regularly to get the most benefit from it. To help||
1249|036|H|you remember, take it at the same time each day.||
1249|037|H|   The dosage is based on your medical condition, response to||
1249|038|H|treatment, and lab tests. Consult your doctor or pharmacist for||
1249|039|H|more details.||
1249|040|H|   There are many brands and forms of cyanocobalamin (vitamin||
1249|041|H|B12) available. Read the dosing instructions carefully for each||
1249|042|H|product because the amount of cyanocobalamin (vitamin B12) may be||
1249|043|H|different between products.||
1249|044|H|   If you are using the liquid form of this medication, carefully||
1249|045|H|measure the dose using a special measuring device/spoon. Do not||
1249|046|H|use a household spoon because you may not get the correct dose.||
1249|047|H|Some liquid brands may require you to shake the bottle well||
1249|048|H|before each dose.||
1249|049|H|   If you are taking the extended-release tablets, do not crush||
1249|050|H|or chew them. Doing so can release all of the drug at once,||
1249|051|H|increasing the risk of side effects. Swallow the tablets whole.||
1249|052|H|   If you are taking the chewable tablet, chew the medication||
1249|053|H|thoroughly before swallowing.||
1249|054|H|   If you are taking the rapidly-dissolving tablets, dissolve in||
1249|055|H|the mouth with or without water as directed by your doctor or the||
1249|056|H|product package.||
1249|057|H|   Vitamin C (ascorbic acid) can decrease the amount of vitamin||
1249|058|H|B12 you absorb. Avoid taking large doses of vitamin C within one||
1249|059|H|hour before or after taking this product.||
1249|060|H|   If your condition lasts or gets worse, or if you think you may||
1249|061|H|have a serious medical problem, get medical help right away.||
1249|062|B|||
1249|063|S|SIDE EFFECTS:  This product usually has no side effects. If you||
1249|064|S|have any unusual effects, contact your doctor or pharmacist||
1249|065|S|promptly.||
1249|066|S|   If your doctor has directed you to use this medication,||
1249|067|S|remember that your doctor has judged that the benefit to you is||
1249|068|S|greater than the risk of side effects. Many people using this||
1249|069|S|medication do not have serious side effects.||
1249|070|S|   If you have severe anemia, this medication may rarely cause||
1249|071|S|low potassium levels in the blood (hypokalemia) as your body||
1249|072|S|makes new red blood cells. Tell your doctor right away if any of||
1249|073|S|these serious side effects occur: muscle cramps, weakness,||
1249|074|S|irregular heartbeat.||
1249|075|S|   A very serious allergic reaction to this drug is rare.||
1249|076|S|However, get medical help right away if you notice any symptoms||
1249|077|S|of a serious allergic reaction, including: rash, itching/swelling||
1249|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1249|079|S|breathing.||
1249|080|S|   This is not a complete list of possible side effects. If you||
1249|081|S|notice other effects not listed above, contact your doctor or||
1249|082|S|pharmacist.||
1249|083|S|   In the US -||
1249|084|S|   Call your doctor for medical advice about side effects. You||
1249|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1249|086|S|www.fda.gov/medwatch.||
1249|087|S|   In Canada - Call your doctor for medical advice about side||
1249|088|S|effects. You may report side effects to Health Canada at||
1249|089|S|1-866-234-2345.||
1249|090|B|||
1249|091|P|PRECAUTIONS:  Before taking cyanocobalamin, tell your doctor or||
1249|092|P|pharmacist if you are allergic to it; or to any form of vitamin||
1249|093|P|B12; or to cobalt; or if you have any other allergies. This||
1249|094|P|product may contain inactive ingredients, which can cause||
1249|095|P|allergic reactions or other problems. Talk to your pharmacist for||
1249|096|P|more details.||
1249|097|P|   If you have any of the following health problems, consult your||
1249|098|P|doctor or pharmacist before using this medication: a certain eye||
1249|099|P|disease (Leber's optic neuropathy), a certain blood disorder||
1249|100|P|(polycythemia vera), gout, iron or folic acid deficiency anemia,||
1249|101|P|low potassium blood levels (hypokalemia).||
1249|102|P|   Cyanocobalamin taken by mouth should only be used if your body||
1249|103|P|can properly absorb it. You may need a form of vitamin B12 that||
1249|104|P|is injected or inhaled in the nose if you have any of the||
1249|105|P|following health problems: pernicious anemia, food absorption||
1249|106|P|problems, stomach/intestinal surgery (such as gastric bypass or||
1249|107|P|bowel resection), stomach/intestinal disease (such as Crohn's||
1249|108|P|disease, colitis, diverticulitis, pancreatic insufficiency),||
1249|109|P|irradiation of the small bowel.||
1249|110|P|   Before having surgery, tell your doctor or dentist about all||
1249|111|P|the products you use (including prescription drugs,||
1249|112|P|nonprescription drugs, and herbal products).||
1249|113|P|   Cyanocobalamin is safe to use during pregnancy when taken in||
1249|114|P|recommended doses. Higher doses should be used only when clearly||
1249|115|P|needed. Discuss the risks and benefits with your doctor.||
1249|116|P|   Cyanocobalamin passes into breast milk and is unlikely to harm||
1249|117|P|a nursing infant when used in recommended doses. Consult your||
1249|118|P|doctor before breastfeeding.||
1249|119|B|||
1249|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1249|121|I|medications work or increase your risk for serious side effects.||
1249|122|I|This document does not contain all possible drug interactions.||
1249|123|I|Keep a list of all the products you use (including||
1249|124|I|prescription/nonprescription drugs and herbal products) and share||
1249|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1249|126|I|the dosage of any medicines without your doctor's approval.||
1249|127|I|   This medication may interfere with certain lab tests (such as||
1249|128|I|intrinsic factor, blood tests for other types of anemia),||
1249|129|I|possibly causing false test results. Make sure lab personnel and||
1249|130|I|all your doctors know you use this drug.||
1249|131|B|||
1249|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1249|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1249|134|O|poison control center right away. US residents can call||
1249|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1249|136|B|||
1249|137|N|NOTES:  Lab and/or medical tests (such as vitamin B12 levels,||
1249|138|N|complete blood count, blood potassium levels) may be done while||
1249|139|N|you are taking this medication. Keep all medical and lab||
1249|140|N|appointments. Consult your doctor for more details.||
1249|141|N|   Remember that it is best to get your vitamins and minerals||
1249|142|N|from food whenever possible. Eat a well-balanced diet, and follow||
1249|143|N|any dietary guidelines as directed by your doctor. Foods rich in||
1249|144|N|vitamin B12 include meat, poultry, shellfish, eggs, milk, and||
1249|145|N|other dairy products.||
1249|146|B|||
1249|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1249|148|D|remember. If it is near the time of the next dose, skip the||
1249|149|D|missed dose. Take your next dose at the regular time. Do not||
1249|150|D|double the dose to catch up.||
1249|151|B|||
1249|152|R|STORAGE:  Store at room temperature away from light and moisture.||
1249|153|R|Do not store in the bathroom. Different brands of this medication||
1249|154|R|may have different storage needs. Check the product package for||
1249|155|R|specific instructions on how to store your brand, or ask your||
1249|156|R|pharmacist. Keep all medications away from children and pets.||
1249|157|R|   Do not flush medications down the toilet or pour them into a||
1249|158|R|drain unless instructed to do so. Properly discard this product||
1249|159|R|when it is expired or no longer needed. Consult your pharmacist||
1249|160|R|or local waste disposal company.||
1249|161|B|||
1249|162|A|Information last revised May 2024.||
1249|163|A|Copyright(c) 2025 First Databank, Inc.||
1249|164|B|||
1252|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1252|002|Z|does NOT have all possible information about this product. This||
1252|003|Z|information does not assure that this product is safe, effective,||
1252|004|Z|or appropriate for you. This information is not individual||
1252|005|Z|medical advice and does not substitute for the advice of your||
1252|006|Z|health care professional. Always ask your health care||
1252|007|Z|professional for complete information about this product and your||
1252|008|Z|specific health needs.||
1252|009|B|||
1252|010|T|LIDOCAINE PATCH - TOPICAL||
1252|011|F|(LYE-doe-kane)||
1252|012|B|||
1252|013|C|COMMON BRAND NAME(S): Lidoderm||
1252|014|B|||
1252|015|U|USES:  This product is used to help reduce itching and pain from||
1252|016|U|certain skin conditions (such as scrapes, minor skin irritations,||
1252|017|U|insect bites). It may also be used to help relieve nerve pain||
1252|018|U|after shingles (infection with herpes zoster virus). Lidocaine||
1252|019|U|belongs to a class of drugs known as local anesthetics. It works||
1252|020|U|by causing a temporary loss of feeling in the area where you||
1252|021|U|apply the patch.||
1252|022|B|||
1252|023|H|HOW TO USE:  If you are using the over-the-counter product to||
1252|024|H|self-treat, read and follow all directions on the product package||
1252|025|H|before using this medication. If you have any questions, consult||
1252|026|H|your pharmacist. If your doctor has prescribed this medication,||
1252|027|H|use it as directed.||
1252|028|H|   This product should only be applied to normal intact skin. Do||
1252|029|H|not apply to skin that is broken or irritated. The dosage is||
1252|030|H|based on your medical condition and response to treatment.||
1252|031|H|   Remove the protective liner and apply the patch to the skin||
1252|032|H|area that is most painful. Apply the prescribed number of patches||
1252|033|H|as directed by your doctor, usually once a day. Depending on your||
1252|034|H|product, the patch may be left on the skin for up to 8 or 12||
1252|035|H|hours. Follow the instructions carefully. Do not apply more than||
1252|036|H|3 patches once a day or leave any patch on for longer than the||
1252|037|H|stated time period. If a smaller patch is needed, it may be cut||
1252|038|H|with scissors before the liner is removed. It is best to avoid||
1252|039|H|getting the patch wet since it may not stick to the skin. Some||
1252|040|H|brands may be wet in water for a short time (such as showering||
1252|041|H|for10 minutes). Pat dry gently if you get the patch wet.||
1252|042|H|   Wash your hands well after each application. Avoid getting||
1252|043|H|this medication in your eyes or mucous membranes (such as nose,||
1252|044|H|mouth). If contact with the eyes accidentally occurs, wash your||
1252|045|H|eyes right away with water and protect them until normal feeling||
1252|046|H|returns.||
1252|047|H|   If your condition does not get better, or if it gets worse, or||
1252|048|H|if you think you may have a serious medical problem, get medical||
1252|049|H|help right away.||
1252|050|H|   Used patches still contain some medication. However, do not||
1252|051|H|reuse them. Fold the used patch with the sticky sides together||
1252|052|H|and discard it out of the reach of children and pets to prevent||
1252|053|H|accidental swallowing or application.||
1252|054|B|||
1252|055|S|SIDE EFFECTS:  Redness, swelling, blisters, or changes in skin||
1252|056|S|color at the site of application may occur. These effects usually||
1252|057|S|disappear within a few minutes or hours. If any of these effects||
1252|058|S|last or get worse, tell your doctor or pharmacist promptly.||
1252|059|S|   If irritation or a burning feeling occurs, remove the||
1252|060|S|patch(es) and do not reapply until the irritation is gone.||
1252|061|S|   If your doctor has directed you to use this medication,||
1252|062|S|remember that your doctor has judged that the benefit to you is||
1252|063|S|greater than the risk of side effects. Many people using this||
1252|064|S|medication do not have serious side effects.||
1252|065|S|   Tell your doctor right away if you have any serious side||
1252|066|S|effects, including: blurred vision, mental/mood changes (such as||
1252|067|S|nervousness, confusion), drowsiness, dizziness, unusually slow||
1252|068|S|heartbeat.||
1252|069|S|   Get medical help right away if you have any very serious side||
1252|070|S|effects, including: pale/bluish/gray skin, unusual tiredness,||
1252|071|S|shortness of breath, fast heartbeat.||
1252|072|S|   A very serious allergic reaction to this drug is rare.||
1252|073|S|However, get medical help right away if you notice any symptoms||
1252|074|S|of a serious allergic reaction, including: rash, itching/swelling||
1252|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1252|076|S|breathing.||
1252|077|S|   This is not a complete list of possible side effects. If you||
1252|078|S|notice other effects not listed above, contact your doctor or||
1252|079|S|pharmacist.||
1252|080|S|   In the US -||
1252|081|S|   Call your doctor for medical advice about side effects. You||
1252|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1252|083|S|www.fda.gov/medwatch.||
1252|084|S|   In Canada - Call your doctor for medical advice about side||
1252|085|S|effects. You may report side effects to Health Canada at||
1252|086|S|1-866-234-2345.||
1252|087|B|||
1252|088|P|PRECAUTIONS:  Before using lidocaine, tell your doctor or||
1252|089|P|pharmacist if you are allergic to it; or to other local||
1252|090|P|anesthetics; or if you have any other allergies. This product may||
1252|091|P|contain inactive ingredients, which can cause allergic reactions||
1252|092|P|or other problems. Talk to your pharmacist for more details.||
1252|093|P|   Before using this medication, tell your doctor or pharmacist||
1252|094|P|your medical history, especially of: liver disease, a certain||
1252|095|P|blood disorder (methemoglobinemia).||
1252|096|P|   While wearing your patch, avoid exposing it to direct heat||
1252|097|P|sources such as heating pads, electric blankets, heat lamps,||
1252|098|P|saunas, hot tubs, heated waterbeds, or prolonged direct sunlight.||
1252|099|P|Heat may cause more drug to be released into your body,||
1252|100|P|increasing the chance of side effects.||
1252|101|P|   If you are going to have an MRI test, tell testing personnel||
1252|102|P|that you are using this patch. Some patches may contain metals||
1252|103|P|that can cause serious burns during an MRI. Ask your doctor||
1252|104|P|whether you will need to remove your patch before the test and||
1252|105|P|apply a new patch afterward, and how to do so properly.||
1252|106|P|   During pregnancy, this medication should be used only when||
1252|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
1252|108|P|   This medication passes into breast milk, but is unlikely to||
1252|109|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1252|110|B|||
1252|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1252|112|I|medications work or increase your risk for serious side effects.||
1252|113|I|This document does not contain all possible drug interactions.||
1252|114|I|Keep a list of all the products you use (including||
1252|115|I|prescription/nonprescription drugs and herbal products) and share||
1252|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1252|117|I|the dosage of any medicines without your doctor's approval.||
1252|118|B|||
1252|119|O|OVERDOSE:  This medication patch may be harmful if chewed or||
1252|120|O|swallowed. If someone has overdosed, remove the patch if||
1252|121|O|possible. For serious symptoms such as passing out or trouble||
1252|122|O|breathing, call 911. Otherwise, call a poison control center||
1252|123|O|right away. US residents can call 1-800-222-1222. Canada||
1252|124|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1252|125|O|include: severe drowsiness, seizures, slowed breathing,||
1252|126|O|slow/fast/irregular heartbeat.||
1252|127|B|||
1252|128|N|NOTES:  Keep all medical and lab appointments.||
1252|129|B|||
1252|130|D|MISSED DOSE:  If you are using this product on a regular schedule||
1252|131|D|and miss a dose, use it as soon as you remember. If it is near||
1252|132|D|the time of the next dose, skip the missed dose. Use your next||
1252|133|D|dose at the regular time. Do not double the dose to catch up.||
1252|134|B|||
1252|135|R|STORAGE:  Store at room temperature. Keep the patch sealed in its||
1252|136|R|protective envelope until ready to use. Keep all medications away||
1252|137|R|from children and pets.||
1252|138|R|   Do not flush medications down the toilet or pour them into a||
1252|139|R|drain unless instructed to do so. Properly discard this product||
1252|140|R|when it is expired or no longer needed (See How to Use section).||
1252|141|B|||
1252|142|A|Information last revised February 2025.||
1252|143|A|Copyright(c) 2025 First Databank, Inc.||
1252|144|B|||
1253|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1253|002|Z|does NOT have all possible information about this product. This||
1253|003|Z|information does not assure that this product is safe, effective,||
1253|004|Z|or appropriate for you. This information is not individual||
1253|005|Z|medical advice and does not substitute for the advice of your||
1253|006|Z|health care professional. Always ask your health care||
1253|007|Z|professional for complete information about this product and your||
1253|008|Z|specific health needs.||
1253|009|B|||
1253|010|T|BETAMETHASONE FOAM - TOPICAL||
1253|011|F|(BAY-ta-METH-a-sone)||
1253|012|B|||
1253|013|C|COMMON BRAND NAME(S): Luxiq||
1253|014|B|||
1253|015|U|USES:  This medication is used to treat skin conditions of the||
1253|016|U|scalp (such as psoriasis, seborrhea). Betamethasone works by||
1253|017|U|decreasing the swelling (inflammation), itching, and redness. It||
1253|018|U|belongs to a class of drugs known as corticosteroids. This||
1253|019|U|medication is a medium-strength corticosteroid.||
1253|020|B|||
1253|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1253|022|H|from your pharmacist before you start using this medication and||
1253|023|H|each time you get a refill. If you have any questions, ask your||
1253|024|H|doctor or pharmacist.||
1253|025|H|   This medication is for use only on the skin. Apply to the||
1253|026|H|scalp as directed by your doctor, usually twice daily (in the||
1253|027|H|morning and evening).||
1253|028|H|   To apply this medication, turn the container upside down, and||
1253|029|H|spray out a small amount on a clean, cool surface (such as a||
1253|030|H|small plate or saucer). Dispense only enough foam to cover the||
1253|031|H|affected areas on the scalp. Do not spray the foam directly on||
1253|032|H|your hands since warm skin will cause the foam to melt too||
1253|033|H|quickly. Using your fingers, scoop up some of the foam and gently||
1253|034|H|massage it into the affected area until the foam is absorbed.||
1253|035|H|Repeat until the entire affected area is treated. Discard any||
1253|036|H|leftover drug from the saucer. Do not cover the treated area with||
1253|037|H|bandages or other dressings unless instructed to do so by your||
1253|038|H|doctor. Do not wash or rinse the medication off immediately after||
1253|039|H|applying it. Wash your hands with soap and water after each use.||
1253|040|H|   Avoid getting this medication in your eyes, nose, or mouth. If||
1253|041|H|this occurs, rinse thoroughly with water and call your doctor if||
1253|042|H|irritation lasts.||
1253|043|H|   This medication is flammable until dry. Avoid smoking or being||
1253|044|H|near open flames while using the medication and until the||
1253|045|H|medication has dried.||
1253|046|H|   Use this medication regularly to get the most benefit from it.||
1253|047|H|To help you remember, use it at the same times each day. Do not||
1253|048|H|apply large amounts of this medication, use it more often, or use||
1253|049|H|it for longer than prescribed. Your condition will not improve||
1253|050|H|any faster, and your risk of side effects may increase.||
1253|051|H|   Tell your doctor if your condition does not get better after 2||
1253|052|H|weeks of treatment or if it gets worse.||
1253|053|B|||
1253|054|S|SIDE EFFECTS:  Burning, itching, or stinging may occur when you||
1253|055|S|apply this medication, but usually only last a short time. If any||
1253|056|S|of these effects last or get worse, tell your doctor or||
1253|057|S|pharmacist promptly.||
1253|058|S|   Remember that this medication has been prescribed because your||
1253|059|S|doctor has judged that the benefit to you is greater than the||
1253|060|S|risk of side effects. Many people using this medication do not||
1253|061|S|have serious side effects.||
1253|062|S|   Tell your doctor right away if you have any serious side||
1253|063|S|effects, including: stretch marks, skin thinning/discoloration,||
1253|064|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
1253|065|S|(folliculitis).||
1253|066|S|   Rarely, it is possible this medication will be absorbed from||
1253|067|S|the skin into the bloodstream. This can lead to side effects of||
1253|068|S|too much corticosteroid. These side effects are more likely in||
1253|069|S|children, and in people who use this medication for a long time||
1253|070|S|or over large areas of the skin. Tell your doctor right away if||
1253|071|S|any of the following side effects occur: unusual/extreme||
1253|072|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
1253|073|S|thirst/urination, vision problems.||
1253|074|S|   A very serious allergic reaction to this drug is rare.||
1253|075|S|However, get medical help right away if you notice any symptoms||
1253|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1253|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1253|078|S|breathing.||
1253|079|S|   This is not a complete list of possible side effects. If you||
1253|080|S|notice other effects not listed above, contact your doctor or||
1253|081|S|pharmacist.||
1253|082|S|   In the US -||
1253|083|S|   Call your doctor for medical advice about side effects. You||
1253|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1253|085|S|www.fda.gov/medwatch.||
1253|086|S|   In Canada - Call your doctor for medical advice about side||
1253|087|S|effects. You may report side effects to Health Canada at||
1253|088|S|1-866-234-2345.||
1253|089|B|||
1253|090|P|PRECAUTIONS:  Before using betamethasone, tell your doctor or||
1253|091|P|pharmacist if you are allergic to it; or to other corticosteroids||
1253|092|P|(such as hydrocortisone); or if you have any other allergies.||
1253|093|P|This product may contain inactive ingredients, which can cause||
1253|094|P|allergic reactions or other problems. Talk to your pharmacist for||
1253|095|P|more details.||
1253|096|P|   Before using this medication, tell your doctor or pharmacist||
1253|097|P|your medical history, especially of: poor blood circulation, a||
1253|098|P|lowered immune system.||
1253|099|P|   Do not use this medication if you have a scalp infection.||
1253|100|P|Corticosteroids can make skin infections worse and more difficult||
1253|101|P|to treat. Tell your doctor if you have a skin infection so it can||
1253|102|P|be treated. Tell your doctor promptly if your condition does not||
1253|103|P|improve or if you have worsening skin symptoms.||
1253|104|P|   Rarely, using corticosteroid medications for a long time or||
1253|105|P|over large areas of skin can make it more difficult for your body||
1253|106|P|to respond to physical stress. Before having surgery or emergency||
1253|107|P|treatment, or if you get a serious illness/injury, tell your||
1253|108|P|doctor or dentist that you are using this medication or have used||
1253|109|P|this medication within the past few months.||
1253|110|P|   Though it is unlikely, this medication may temporarily slow||
1253|111|P|down a child's growth if used for a long time. See the doctor||
1253|112|P|regularly so your child's height can be checked.||
1253|113|P|   Before having surgery, tell your doctor or dentist about all||
1253|114|P|the products you use (including prescription drugs,||
1253|115|P|nonprescription drugs, and herbal products).||
1253|116|P|   During pregnancy, this medication should be used only when||
1253|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
1253|118|P|   It is unknown if this medication passes into breast milk.||
1253|119|P|Consult your doctor before breastfeeding.||
1253|120|B|||
1253|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1253|122|I|medications work or increase your risk for serious side effects.||
1253|123|I|This document does not contain all possible drug interactions.||
1253|124|I|Keep a list of all the products you use (including||
1253|125|I|prescription/nonprescription drugs and herbal products) and share||
1253|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
1253|127|I|the dosage of any medicines without your doctor's approval.||
1253|128|B|||
1253|129|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1253|130|O|has overdosed and has serious symptoms such as passing out or||
1253|131|O|trouble breathing, call 911. Otherwise, call a poison control||
1253|132|O|center right away. US residents can call 1-800-222-1222. Canada||
1253|133|O|residents can call 1-844-764-7669.||
1253|134|B|||
1253|135|N|NOTES:  Do not share this medication with others.||
1253|136|N|   This medication has been prescribed for your current condition||
1253|137|N|only. Do not use it later for other skin problems unless told to||
1253|138|N|do so by your doctor. A different medication may be necessary in||
1253|139|N|those cases.||
1253|140|N|   Lab and/or medical tests (such as adrenal gland function) may||
1253|141|N|be done while you are using this medication, especially if you||
1253|142|N|use this drug for an extended period of time or apply it over||
1253|143|N|large areas of the body. Keep all medical and lab appointments.||
1253|144|N|Consult your doctor for more details.||
1253|145|B|||
1253|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1253|147|D|If it is near the time of the next dose, skip the missed dose.||
1253|148|D|Use your next dose at the regular time. Do not double the dose to||
1253|149|D|catch up.||
1253|150|B|||
1253|151|R|STORAGE:  Store at room temperature away from direct sunlight.||
1253|152|R|This product is flammable and the contents under pressure. Keep||
1253|153|R|it away from heat and open flame. Do not puncture or burn it.||
1253|154|R|Keep all medications away from children and pets.||
1253|155|R|   Do not flush medications down the toilet or pour them into a||
1253|156|R|drain unless instructed to do so. Properly discard this product||
1253|157|R|when it is expired or no longer needed. Consult your pharmacist||
1253|158|R|or local waste disposal company.||
1253|159|B|||
1253|160|A|Information last revised July 2025.||
1253|161|A|Copyright(c) 2025 First Databank, Inc.||
1253|162|B|||
1254|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1254|002|Z|does NOT have all possible information about this product. This||
1254|003|Z|information does not assure that this product is safe, effective,||
1254|004|Z|or appropriate for you. This information is not individual||
1254|005|Z|medical advice and does not substitute for the advice of your||
1254|006|Z|health care professional. Always ask your health care||
1254|007|Z|professional for complete information about this product and your||
1254|008|Z|specific health needs.||
1254|009|B|||
1254|010|T|ASENAPINE - SUBLINGUAL||
1254|011|F|(a-SEN-a-peen)||
1254|012|B|||
1254|013|C|COMMON BRAND NAME(S): Saphris||
1254|014|B|||
1254|015|W|WARNING:  There may be a slightly increased risk of serious,||
1254|016|W|possibly fatal side effects (such as stroke, heart failure,||
1254|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1254|018|W|by older adults with dementia. This medication is not approved||
1254|019|W|for the treatment of dementia-related behavior problems. Discuss||
1254|020|W|the risks and benefits of this medication, as well as other||
1254|021|W|effective and possibly safer treatments for dementia-related||
1254|022|W|behavior problems, with the doctor.||
1254|023|W|   If you are using asenapine in combination with other||
1254|024|W|medication to treat depression, also carefully read the drug||
1254|025|W|information for the other medication.||
1254|026|B|||
1254|027|U|USES:  This medication is used to treat certain mental/mood||
1254|028|U|disorders (such as schizophrenia, bipolar disorder). Asenapine||
1254|029|U|belongs to a class of drugs known as atypical antipsychotics. It||
1254|030|U|works by helping to restore the balance of certain natural||
1254|031|U|substances in the brain.||
1254|032|B|||
1254|033|V|OTHER USES:  This section contains uses of this drug that are not||
1254|034|V|listed in the approved professional labeling for the drug but||
1254|035|V|that may be prescribed by your health care professional. Use this||
1254|036|V|drug for a condition that is listed in this section only if it||
1254|037|V|has been so prescribed by your health care professional.||
1254|038|V|   This drug may also be used in combination with other||
1254|039|V|medication for depression.||
1254|040|B|||
1254|041|H|HOW TO USE:  Take this medication as directed by your doctor,||
1254|042|H|usually 2 times a day. Gently remove the medication from the||
1254|043|H|packaging with dry hands by peeling back the tab. Do not push the||
1254|044|H|tablet through the packaging. Place your dose of this medication||
1254|045|H|under the tongue and allow it to dissolve completely in your||
1254|046|H|saliva. Do not chew, crush, split, or swallow the tablet whole.||
1254|047|H|Do not eat or drink anything for 10 minutes after taking this||
1254|048|H|medication.||
1254|049|H|   The dosage is based on your medical condition, response to||
1254|050|H|treatment, and other medications you may be taking. Be sure to||
1254|051|H|tell your doctor and pharmacist about all the products you use||
1254|052|H|(including prescription drugs, nonprescription drugs, and herbal||
1254|053|H|products).||
1254|054|H|   Take this medication regularly to get the most benefit from||
1254|055|H|it. To help you remember, take it at the same times each day. It||
1254|056|H|may take several weeks before you get the full benefit of this||
1254|057|H|drug.||
1254|058|H|   Keep taking this medication even if you feel well. Do not||
1254|059|H|increase your dose or take this drug more often than prescribed.||
1254|060|H|Your condition will not improve any faster, and your risk of side||
1254|061|H|effects will increase. Do not stop taking this medication without||
1254|062|H|consulting your doctor.||
1254|063|H|   Tell your doctor if your condition does not get better or if||
1254|064|H|it gets worse.||
1254|065|B|||
1254|066|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, and weight||
1254|067|S|gain may occur. Numbness/tingling of the mouth may also occur but||
1254|068|S|usually goes away within 1 hour. Sores, blisters, or pain under||
1254|069|S|the tongue may rarely occur. If any of these effects last or get||
1254|070|S|worse, tell your doctor or pharmacist promptly.||
1254|071|S|   Dizziness and lightheadedness can increase the risk of||
1254|072|S|falling. Get up slowly when rising from a sitting or lying||
1254|073|S|position.||
1254|074|S|   Tell your doctor right away if any of these side effects||
1254|075|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
1254|076|S|mask-like expression of the face, drooling/trouble swallowing, or||
1254|077|S|shuffling walk. Your doctor may prescribe another medication to||
1254|078|S|decrease these side effects.||
1254|079|S|   Remember that this medication has been prescribed because your||
1254|080|S|doctor has judged that the benefit to you is greater than the||
1254|081|S|risk of side effects. Many people using this medication do not||
1254|082|S|have serious side effects.||
1254|083|S|   Rarely, this medication may cause face/muscle twitching and||
1254|084|S|uncontrollable movements (tardive dyskinesia). In some cases,||
1254|085|S|this condition may be permanent. Tell your doctor right away if||
1254|086|S|you develop any uncontrollable movements such as lip smacking,||
1254|087|S|mouth puckering, tongue thrusting, chewing, or unusual arm/leg||
1254|088|S|movements.||
1254|089|S|   This drug may rarely make your blood sugar rise, which can||
1254|090|S|cause or worsen diabetes. Weight gain from this drug may increase||
1254|091|S|the risk of this side effect. Tell your doctor right away if you||
1254|092|S|have symptoms of high blood sugar such as increased||
1254|093|S|thirst/urination. If you already have diabetes, check your blood||
1254|094|S|sugar regularly as directed and share the results with your||
1254|095|S|doctor. Your doctor may need to adjust your diabetes medication,||
1254|096|S|exercise program, or diet.||
1254|097|S|   In rare cases, asenapine may increase your level of a certain||
1254|098|S|substance made by the body (prolactin). For females, this||
1254|099|S|increase in prolactin may result in unwanted breast milk,||
1254|100|S|missed/stopped periods, or difficulty becoming pregnant. For||
1254|101|S|males, it may result in decreased sexual ability, inability to||
1254|102|S|produce sperm, or enlarged breasts. If you develop any of these||
1254|103|S|symptoms, tell your doctor right away.||
1254|104|S|   Rarely, with similar drugs, males may have a painful or||
1254|105|S|prolonged erection lasting 4 or more hours. If this occurs, stop||
1254|106|S|using this drug and get medical help right away, or permanent||
1254|107|S|problems could occur.||
1254|108|S|   Tell your doctor right away if you have any serious side||
1254|109|S|effects, including: interrupted breathing during sleep (sleep||
1254|110|S|apnea), signs of infection (such as sore throat that doesn't go||
1254|111|S|away, fever, chills).||
1254|112|S|   Get medical help right away if you have any very serious side||
1254|113|S|effects, including: severe dizziness, fainting, slow heartbeat,||
1254|114|S|seizures.||
1254|115|S|   This medication may rarely cause a very serious condition||
1254|116|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1254|117|S|right away if you have any of the following symptoms: fever,||
1254|118|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1254|119|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1254|120|S|signs of kidney problems (such as change in the amount of urine).||
1254|121|S|   A very serious allergic reaction to this drug is rare.||
1254|122|S|However, get medical help right away if you notice any symptoms||
1254|123|S|of a serious allergic reaction, including: rash, itching/swelling||
1254|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1254|125|S|breathing.||
1254|126|S|   This is not a complete list of possible side effects. If you||
1254|127|S|notice other effects not listed above, contact your doctor or||
1254|128|S|pharmacist.||
1254|129|S|   In the US -||
1254|130|S|   Call your doctor for medical advice about side effects. You||
1254|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1254|132|S|www.fda.gov/medwatch.||
1254|133|S|   In Canada - Call your doctor for medical advice about side||
1254|134|S|effects. You may report side effects to Health Canada at||
1254|135|S|1-866-234-2345.||
1254|136|B|||
1254|137|P|PRECAUTIONS:  See also Warning section.||
1254|138|P|   Before taking asenapine, tell your doctor or pharmacist if you||
1254|139|P|are allergic to it; or if you have any other allergies. This||
1254|140|P|product may contain inactive ingredients, which can cause||
1254|141|P|allergic reactions or other problems. Talk to your pharmacist for||
1254|142|P|more details.||
1254|143|P|   Before using this medication, tell your doctor or pharmacist||
1254|144|P|your medical history, especially of: liver problems, heart||
1254|145|P|problems (such as past heart attack, angina, abnormal heart||
1254|146|P|rhythm), stroke, diabetes (including family history), obesity,||
1254|147|P|low blood pressure, seizures, low white blood cell count,||
1254|148|P|dehydration, breast cancer, substance use disorder (such as||
1254|149|P|overuse of or addiction to drugs/alcohol), Alzheimer's disease,||
1254|150|P|dementia, trouble swallowing, breathing trouble during sleep||
1254|151|P|(sleep apnea).||
1254|152|P|   Asenapine may cause a condition that affects the heart rhythm||
1254|153|P|(QT prolongation). QT prolongation can rarely cause serious||
1254|154|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1254|155|P|as severe dizziness, fainting) that need medical attention right||
1254|156|P|away.||
1254|157|P|   The risk of QT prolongation may be increased if you have||
1254|158|P|certain medical conditions or are taking other drugs that may||
1254|159|P|cause QT prolongation. Before using asenapine, tell your doctor||
1254|160|P|or pharmacist of all the drugs you take and if you have any of||
1254|161|P|the following conditions: certain heart problems (heart failure,||
1254|162|P|slow heartbeat, QT prolongation in the EKG), family history of||
1254|163|P|certain heart problems (QT prolongation in the EKG, sudden||
1254|164|P|cardiac death).||
1254|165|P|   Low levels of potassium or magnesium in the blood may also||
1254|166|P|increase your risk of QT prolongation. This risk may increase if||
1254|167|P|you use certain drugs (such as diuretics/"water pills") or if you||
1254|168|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1254|169|P|Talk to your doctor about using asenapine safely.||
1254|170|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1254|171|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1254|172|P|machinery, or do anything that needs alertness until you can do||
1254|173|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1254|174|P|are using marijuana (cannabis).||
1254|175|P|   Before having surgery, tell your doctor or dentist about all||
1254|176|P|the products you use (including prescription drugs,||
1254|177|P|nonprescription drugs, and herbal products).||
1254|178|P|   This medication may make you sweat less, making you more||
1254|179|P|likely to get heat stroke. Avoid doing things that may cause you||
1254|180|P|to overheat, such as hard work or exercise in hot weather, or||
1254|181|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1254|182|P|and dress lightly. If you overheat, quickly look for a place to||
1254|183|P|cool down and rest. Get medical help right away if you have a||
1254|184|P|fever that does not go away, mental/mood changes, headache, or||
1254|185|P|dizziness.||
1254|186|P|   Older adults may be more sensitive to the side effects of this||
1254|187|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
1254|188|P|prolongation (see above). Drowsiness, dizziness, and||
1254|189|P|lightheadedness can increase the risk of falling.||
1254|190|P|   During pregnancy, this medication should be used only when||
1254|191|P|clearly needed. Babies born to mothers who have used this drug||
1254|192|P|during the last 3 months of pregnancy may rarely develop symptoms||
1254|193|P|including muscle stiffness or shakiness, drowsiness,||
1254|194|P|feeding/breathing difficulties, or constant crying. If you notice||
1254|195|P|any of these symptoms in your newborn especially during their||
1254|196|P|first month, tell the doctor right away.||
1254|197|P|   Since untreated mental/mood problems (such as schizophrenia,||
1254|198|P|bipolar disorder, depression) can be a serious condition, do not||
1254|199|P|stop taking this medication unless directed by your doctor. If||
1254|200|P|you are planning pregnancy, become pregnant, or think you may be||
1254|201|P|pregnant, immediately discuss with your doctor the benefits and||
1254|202|P|risks of using this medication during pregnancy.||
1254|203|P|   It is unknown if this medication passes into breast milk.||
1254|204|P|Consult your doctor before breastfeeding.||
1254|205|B|||
1254|206|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1254|207|I|medications work or increase your risk for serious side effects.||
1254|208|I|This document does not contain all possible drug interactions.||
1254|209|I|Keep a list of all the products you use (including||
1254|210|I|prescription/nonprescription drugs and herbal products) and share||
1254|211|I|it with your doctor and pharmacist. Do not start, stop, or change||
1254|212|I|the dosage of any medicines without your doctor's approval.||
1254|213|I|   Asenapine can slow down the removal of other medications from||
1254|214|I|your body, which may affect how they work. One example is||
1254|215|I|paroxetine, among others.||
1254|216|I|   Tell your doctor or pharmacist if you are taking other||
1254|217|I|products that cause drowsiness such as opioid pain or cough||
1254|218|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1254|219|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1254|220|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1254|221|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1254|222|I|diphenhydramine).||
1254|223|I|   Check the labels on all your medicines (such as allergy or||
1254|224|I|cough-and-cold products) because they may contain ingredients||
1254|225|I|that cause drowsiness. Ask your pharmacist about using those||
1254|226|I|products safely.||
1254|227|B|||
1254|228|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1254|229|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1254|230|O|poison control center right away. US residents can call||
1254|231|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1254|232|O|Symptoms of overdose may include: severe drowsiness/deep sleep,||
1254|233|O|agitation, confusion, fainting.||
1254|234|B|||
1254|235|N|NOTES:  Do not share this medication with others.||
1254|236|N|   Lab and/or medical tests (such as weight, blood sugar, blood||
1254|237|N|pressure, complete blood counts, cholesterol/triglyceride levels)||
1254|238|N|should be done while you are using this medication. Keep all||
1254|239|N|medical and lab appointments.||
1254|240|B|||
1254|241|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1254|242|D|remember. If it is near the time of the next dose, skip the||
1254|243|D|missed dose. Take your next dose at the regular time. Do not||
1254|244|D|double the dose to catch up.||
1254|245|B|||
1254|246|R|STORAGE:  Store at room temperature away from light and moisture.||
1254|247|R|Do not store in the bathroom. Keep all medications away from||
1254|248|R|children and pets.||
1254|249|R|   Do not flush medications down the toilet or pour them into a||
1254|250|R|drain unless instructed to do so. Properly discard this product||
1254|251|R|when it is expired or no longer needed. Consult your pharmacist||
1254|252|R|or local waste disposal company.||
1254|253|B|||
1254|254|A|Information last revised April 2025.||
1254|255|A|Copyright(c) 2025 First Databank, Inc.||
1254|256|B|||
1255|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1255|002|Z|does NOT have all possible information about this product. This||
1255|003|Z|information does not assure that this product is safe, effective,||
1255|004|Z|or appropriate for you. This information is not individual||
1255|005|Z|medical advice and does not substitute for the advice of your||
1255|006|Z|health care professional. Always ask your health care||
1255|007|Z|professional for complete information about this product and your||
1255|008|Z|specific health needs.||
1255|009|B|||
1255|010|T|GUANFACINE EXTENDED-RELEASE - ORAL||
1255|011|F|(GWAN-fuh-seen)||
1255|012|B|||
1255|013|C|COMMON BRAND NAME(S): Intuniv||
1255|014|B|||
1255|015|U|USES:  This medication is used to treat attention deficit||
1255|016|U|hyperactivity disorder (ADHD), as part of a total treatment plan||
1255|017|U|including psychological, educational, and social measures. Unlike||
1255|018|U|other drugs used to treat ADHD, guanfacine is not a stimulant.||
1255|019|U|The exact way that guanfacine works to treat ADHD is unknown.||
1255|020|U|Guanfacine is thought to affect receptors in the parts of the||
1255|021|U|brain that lead to strengthening working memory, reducing||
1255|022|U|distraction, and improving attention and impulse control.||
1255|023|U|Guanfacine may help lessen ADHD symptoms such as being||
1255|024|U|disruptive, inattentive, hyperactive, impulsive, and arguing with||
1255|025|U|adults or losing one's temper.||
1255|026|B|||
1255|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1255|028|H|from your pharmacist before you start using guanfacine and each||
1255|029|H|time you get a refill. If you have any questions, ask your doctor||
1255|030|H|or pharmacist.||
1255|031|H|   Take this medication by mouth as directed by your doctor,||
1255|032|H|usually once daily in the morning or evening. Do not take this||
1255|033|H|medication with a high-fat meal. Doing so may increase the amount||
1255|034|H|of drug you absorb, leading to increased side effects. Swallow||
1255|035|H|this medication whole. Do not crush, chew, or split tablets.||
1255|036|H|Doing so can release all of the drug at once, increasing the risk||
1255|037|H|of side effects.||
1255|038|H|   Do not switch between different forms of this medication||
1255|039|H|without talking with your doctor, because different forms of this||
1255|040|H|medication may not provide the same amount of guanfacine.||
1255|041|H|   Use this medication exactly as prescribed. The dosage is based||
1255|042|H|on your medical condition, weight, response to treatment, and||
1255|043|H|other medications you may be taking. Be sure to tell your doctor||
1255|044|H|and pharmacist about all the products you use (including||
1255|045|H|prescription drugs, nonprescription drugs, and herbal products).||
1255|046|H|   To reduce the risks of side effects (such as low blood||
1255|047|H|pressure, slow heart rate, drowsiness), your doctor may start you||
1255|048|H|at a low dose and gradually increase your dose. Follow your||
1255|049|H|doctor's instructions carefully. Do not take more or less||
1255|050|H|medication or take it more often than prescribed. Your condition||
1255|051|H|will not improve any faster and your risks of side effects will||
1255|052|H|increase. Use this medication regularly to get the most benefit||
1255|053|H|from it. To help you remember, take it at the same time each day.||
1255|054|H|   Do not stop taking this medication without consulting your||
1255|055|H|doctor. Some conditions may become worse when this drug is||
1255|056|H|suddenly stopped. Also, you may experience symptoms such as||
1255|057|H|headache, nervousness, agitation, tremor, fast heartbeat, and||
1255|058|H|high blood pressure. To prevent these symptoms while you are||
1255|059|H|stopping treatment with this drug, your doctor may reduce your||
1255|060|H|dose gradually. Ask your doctor or pharmacist for more details.||
1255|061|H|Report any new or worsening symptoms right away.||
1255|062|H|   Tell your doctor if your condition lasts or gets worse.||
1255|063|B|||
1255|064|S|SIDE EFFECTS:  Drowsiness, dizziness, dry mouth, constipation,||
1255|065|S|tiredness, nausea, headache, and stomach pain may occur. If any||
1255|066|S|of these effects last or get worse, tell your doctor or||
1255|067|S|pharmacist promptly.||
1255|068|S|   To reduce the risk of dizziness and lightheadedness, get up||
1255|069|S|slowly when rising from a sitting or lying position.||
1255|070|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
1255|071|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1255|072|S|substitute.||
1255|073|S|   Remember that this medication has been prescribed because your||
1255|074|S|doctor has judged that the benefit to you is greater than the||
1255|075|S|risk of side effects. Many people using this medication do not||
1255|076|S|have serious side effects.||
1255|077|S|   Tell your doctor right away if you have any serious side||
1255|078|S|effects, including: slow heartbeat, fainting, mental/mood changes||
1255|079|S|(such as depression, hallucinations, thoughts of suicide).||
1255|080|S|   A very serious allergic reaction to this drug is rare.||
1255|081|S|However, get medical help right away if you notice any symptoms||
1255|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1255|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1255|084|S|breathing.||
1255|085|S|   This is not a complete list of possible side effects. If you||
1255|086|S|notice other effects not listed above, contact your doctor or||
1255|087|S|pharmacist.||
1255|088|S|   In the US -||
1255|089|S|   Call your doctor for medical advice about side effects. You||
1255|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1255|091|S|www.fda.gov/medwatch.||
1255|092|S|   In Canada - Call your doctor for medical advice about side||
1255|093|S|effects. You may report side effects to Health Canada at||
1255|094|S|1-866-234-2345.||
1255|095|B|||
1255|096|P|PRECAUTIONS:  Before taking guanfacine, tell your doctor or||
1255|097|P|pharmacist if you are allergic to it; or if you have any other||
1255|098|P|allergies. This product may contain inactive ingredients, which||
1255|099|P|can cause allergic reactions or other problems. Talk to your||
1255|100|P|pharmacist for more details.||
1255|101|P|   Before using this medication, tell your doctor or pharmacist||
1255|102|P|your medical history, especially of: kidney disease, liver||
1255|103|P|disease, fainting, blood pressure problems (both low or high),||
1255|104|P|heart disease (such as slow heart rate), personal/family history||
1255|105|P|of mental/mood disorders (such as bipolar disorder, depression,||
1255|106|P|suicidal thoughts).||
1255|107|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1255|108|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1255|109|P|machinery, or do anything that needs alertness until you can do||
1255|110|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1255|111|P|are using marijuana (cannabis).||
1255|112|P|   To reduce the risk of dizziness and fainting, avoid becoming||
1255|113|P|dehydrated or overheated during exercise, especially in hot||
1255|114|P|weather. If dizziness occurs, sit or lie down.||
1255|115|P|   Before having surgery, tell your doctor or dentist about all||
1255|116|P|the products you use (including prescription drugs,||
1255|117|P|nonprescription drugs, and herbal products).||
1255|118|P|   Children may be more sensitive to the side effects of this||
1255|119|P|drug, especially hallucinations and mental/mood changes.||
1255|120|P|   Older adults may be more sensitive to the side effects of this||
1255|121|P|drug, especially dizziness (more likely when standing up),||
1255|122|P|drowsiness, slow heartbeat, or depression. Dizziness and||
1255|123|P|drowsiness can increase the risk of falling.||
1255|124|P|   During pregnancy, this medication should be used only when||
1255|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
1255|126|P|   It is unknown if this medication passes into breast milk.||
1255|127|P|Consult your doctor before breastfeeding.||
1255|128|B|||
1255|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1255|130|I|medications work or increase your risk for serious side effects.||
1255|131|I|This document does not contain all possible drug interactions.||
1255|132|I|Keep a list of all the products you use (including||
1255|133|I|prescription/nonprescription drugs and herbal products) and share||
1255|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
1255|135|I|the dosage of any medicines without your doctor's approval.||
1255|136|I|   Tell your doctor or pharmacist if you are taking other||
1255|137|I|products that cause drowsiness including alcohol, marijuana||
1255|138|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1255|139|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1255|140|I|zolpidem), muscle relaxants (such as carisoprodol,||
1255|141|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
1255|142|I|hydrocodone).||
1255|143|I|   Check the labels on all your medicines (such as allergy or||
1255|144|I|cough-and-cold products) because they may contain ingredients||
1255|145|I|that cause drowsiness. Ask your pharmacist about using those||
1255|146|I|products safely.||
1255|147|B|||
1255|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1255|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1255|150|O|poison control center right away. US residents can call||
1255|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1255|152|O|Symptoms of overdose may include: severe drowsiness, severe||
1255|153|O|dizziness, severe tiredness, very slow heartbeat, pinpoint||
1255|154|O|pupils.||
1255|155|B|||
1255|156|N|NOTES:  Do not share this medication with others.||
1255|157|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
1255|158|N|should be done while you are taking this medication. Keep all||
1255|159|N|medical and lab appointments. Consult your doctor for more||
1255|160|N|details.||
1255|161|B|||
1255|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1255|163|D|remember. If it is near the time of the next dose, skip the||
1255|164|D|missed dose. Take your next dose at the regular time. Do not||
1255|165|D|double the dose to catch up. If you miss more than 2 doses in a||
1255|166|D|row, call your doctor to get a new dosing schedule.||
1255|167|B|||
1255|168|R|STORAGE:  Store at room temperature away from light and moisture.||
1255|169|R|Do not store in the bathroom. Keep all medications away from||
1255|170|R|children and pets.||
1255|171|R|   Do not flush medications down the toilet or pour them into a||
1255|172|R|drain unless instructed to do so. Properly discard this product||
1255|173|R|when it is expired or no longer needed. Consult your pharmacist||
1255|174|R|or local waste disposal company.||
1255|175|B|||
1255|176|A|Information last revised May 2024.||
1255|177|A|Copyright(c) 2025 First Databank, Inc.||
1255|178|B|||
1256|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1256|002|Z|does NOT have all possible information about this product. This||
1256|003|Z|information does not assure that this product is safe, effective,||
1256|004|Z|or appropriate for you. This information is not individual||
1256|005|Z|medical advice and does not substitute for the advice of your||
1256|006|Z|health care professional. Always ask your health care||
1256|007|Z|professional for complete information about this product and your||
1256|008|Z|specific health needs.||
1256|009|B|||
1256|010|T|BEPOTASTINE - OPHTHALMIC||
1256|011|F|(BEP-oh-TAS-teen)||
1256|012|B|||
1256|013|C|COMMON BRAND NAME(S): Bepreve||
1256|014|B|||
1256|015|U|USES:  This medication is used to treat itching of the eyes due||
1256|016|U|to allergies. Bepotastine is an antihistamine. It works by||
1256|017|U|blocking a certain natural substance (histamine) that causes||
1256|018|U|allergic symptoms.||
1256|019|U|   Do not use this medication to treat red or irritated eyes due||
1256|020|U|to wearing contact lenses. Contact your doctor for further||
1256|021|U|instructions if this occurs.||
1256|022|B|||
1256|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1256|024|H|directed by your doctor, usually twice a day.||
1256|025|H|   Wash your hands before each use. To avoid contamination, do||
1256|026|H|not touch the dropper tip or let it touch your eye or any other||
1256|027|H|surface.||
1256|028|H|   The preservative in this product may be absorbed by contact||
1256|029|H|lenses. If you wear contact lenses, remove them before using this||
1256|030|H|medication and keep them out of your eyes for at least 10 minutes||
1256|031|H|after each dose.||
1256|032|H|   Tilt your head back, look upward, and pull down the lower||
1256|033|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1256|034|H|and place 1 drop into the pouch. Look downward and gently close||
1256|035|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
1256|036|H|your eye (near the nose) and apply gentle pressure. This will||
1256|037|H|prevent the medication from draining out. Try not to blink and do||
1256|038|H|not rub your eye. Repeat these steps for your other eye if so||
1256|039|H|directed.||
1256|040|H|   Do not rinse the dropper. Replace the dropper cap after each||
1256|041|H|use.||
1256|042|H|   If you are using another kind of eye medication (for example,||
1256|043|H|other drops or ointments), wait at least 5 minutes before||
1256|044|H|applying other medications. Use eye drops before eye ointments to||
1256|045|H|allow the drops to enter the eye.||
1256|046|H|   Wait several minutes for your vision to clear before driving||
1256|047|H|or operating machinery.||
1256|048|H|   Use this medication regularly in order to get the most benefit||
1256|049|H|from it. To help you remember, use it at the same times each day.||
1256|050|H|   Do not use this product if it becomes contaminated (for||
1256|051|H|example, drops turn a dark color). Use of contaminated eye||
1256|052|H|medication can cause infection, serious damage to the eye, and||
1256|053|H|loss of vision. Contact your doctor or pharmacist for more||
1256|054|H|information.||
1256|055|H|   Tell your doctor if your condition does not get better in a||
1256|056|H|few days or if it gets worse.||
1256|057|B|||
1256|058|S|SIDE EFFECTS:  A mild taste in the mouth, headache, eye||
1256|059|S|irritation, or sore throat may occur. If any of these effects||
1256|060|S|last or get worse, tell your doctor or pharmacist promptly.||
1256|061|S|   Remember that this medication has been prescribed because your||
1256|062|S|doctor has judged that the benefit to you is greater than the||
1256|063|S|risk of side effects. Many people using this medication do not||
1256|064|S|have serious side effects.||
1256|065|S|   A very serious allergic reaction to this drug is rare.||
1256|066|S|However, get medical help right away if you notice any symptoms||
1256|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1256|068|S|(especially of the face/tongue/throat), dizziness, trouble||
1256|069|S|breathing.||
1256|070|S|   This is not a complete list of possible side effects. If you||
1256|071|S|notice other effects not listed above, contact your doctor or||
1256|072|S|pharmacist.||
1256|073|S|   In the US -||
1256|074|S|   Call your doctor for medical advice about side effects. You||
1256|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1256|076|S|www.fda.gov/medwatch.||
1256|077|S|   In Canada - Call your doctor for medical advice about side||
1256|078|S|effects. You may report side effects to Health Canada at||
1256|079|S|1-866-234-2345.||
1256|080|B|||
1256|081|P|PRECAUTIONS:  Before using bepotastine, tell your doctor or||
1256|082|P|pharmacist if you are allergic to it; or if you have any other||
1256|083|P|allergies. This product may contain inactive ingredients, which||
1256|084|P|can cause allergic reactions or other problems. Talk to your||
1256|085|P|pharmacist for more details.||
1256|086|P|   Before using this medication, tell your doctor or pharmacist||
1256|087|P|your medical history.||
1256|088|P|   After you apply this drug, your vision may become temporarily||
1256|089|P|blurred or unstable. Do not drive, use machinery, or do anything||
1256|090|P|that needs clear vision until you can do it safely.||
1256|091|P|   Before having surgery, tell your doctor or dentist about all||
1256|092|P|the products you use (including prescription drugs,||
1256|093|P|nonprescription drugs, and herbal products).||
1256|094|P|   If you develop a new eye infection or injury, or require eye||
1256|095|P|surgery, ask your doctor if you should continue to use your||
1256|096|P|current bottle of bepotastine eye drops or start a new bottle.||
1256|097|P|   During pregnancy, this medication should be used only when||
1256|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
1256|099|P|   It is unknown if this drug passes into breast milk. Consult||
1256|100|P|your doctor before breastfeeding.||
1256|101|B|||
1256|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1256|103|I|medications work or increase your risk for serious side effects.||
1256|104|I|This document does not contain all possible drug interactions.||
1256|105|I|Keep a list of all the products you use (including||
1256|106|I|prescription/nonprescription drugs and herbal products) and share||
1256|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1256|108|I|the dosage of any medicines without your doctor's approval.||
1256|109|B|||
1256|110|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1256|111|O|has overdosed and has serious symptoms such as passing out or||
1256|112|O|trouble breathing, call 911. Otherwise, call a poison control||
1256|113|O|center right away. US residents can call 1-800-222-1222. Canada||
1256|114|O|residents can call 1-844-764-7669.||
1256|115|B|||
1256|116|N|NOTES:  Do not share this medication with others.||
1256|117|N|   Ask your doctor about additional ways to reduce your symptoms||
1256|118|N|(such as minimizing your exposure to allergens, using cold||
1256|119|N|compresses and lubricating eye drops).||
1256|120|B|||
1256|121|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1256|122|D|If it is near the time of the next dose, skip the missed dose.||
1256|123|D|Use your next dose at the regular time. Do not double the dose to||
1256|124|D|catch up.||
1256|125|B|||
1256|126|R|STORAGE:  Store at room temperature. Keep all medications away||
1256|127|R|from children and pets.||
1256|128|R|   Do not flush medications down the toilet or pour them into a||
1256|129|R|drain unless instructed to do so. Properly discard this product||
1256|130|R|when it is expired or no longer needed. Consult your pharmacist||
1256|131|R|or local waste disposal company.||
1256|132|B|||
1256|133|A|Information last revised November 2024.||
1256|134|A|Copyright(c) 2025 First Databank, Inc.||
1256|135|B|||
1257|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1257|002|Z|does NOT have all possible information about this product. This||
1257|003|Z|information does not assure that this product is safe, effective,||
1257|004|Z|or appropriate for you. This information is not individual||
1257|005|Z|medical advice and does not substitute for the advice of your||
1257|006|Z|health care professional. Always ask your health care||
1257|007|Z|professional for complete information about this product and your||
1257|008|Z|specific health needs.||
1257|009|B|||
1257|010|T|METHOXSALEN (RAPID) - ORAL||
1257|011|F|(meth-OX-a-len)||
1257|012|B|||
1257|013|C|COMMON BRAND NAME(S): Oxsoralen-Ultra||
1257|014|B|||
1257|015|W|WARNING:  For the treatment of psoriasis, this medication should||
1257|016|W|only be used for severe psoriasis that has not responded well to||
1257|017|W|other treatments since this medication may cause serious side||
1257|018|W|effects (such as cataracts, skin cancer/aging). Consult your||
1257|019|W|doctor for more details.||
1257|020|W|   This medication comes in different dosage forms which do not||
1257|021|W|have the same effects. Do not switch between different dosage||
1257|022|W|forms without talking to your doctor. Each time you get a refill,||
1257|023|W|make sure that you receive the correct form of this medication||
1257|024|W|that your doctor prescribed.||
1257|025|B|||
1257|026|U|USES:  This medication is used along with controlled ultraviolet||
1257|027|U|light (UVA) to help control severe psoriasis. Methoxsalen works||
1257|028|U|by making the skin more sensitive to UVA light. This combination||
1257|029|U|helps to slow the overgrowth of skin cells.||
1257|030|U|   This medication is not recommended for use in children younger||
1257|031|U|than 12 years.||
1257|032|B|||
1257|033|V|OTHER USES:  This section contains uses of this drug that are not||
1257|034|V|listed in the approved professional labeling for the drug but||
1257|035|V|that may be prescribed by your health care professional. Use this||
1257|036|V|drug for a condition that is listed in this section only if it||
1257|037|V|has been so prescribed by your health care professional.||
1257|038|V|   This drug may also be used for other skin conditions (such as||
1257|039|V|vitiligo, cutaneous T-cell lymphoma-CTCL).||
1257|040|B|||
1257|041|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1257|042|H|from your pharmacist before you start taking methoxsalen and each||
1257|043|H|time you get a refill. If you have any questions, ask your doctor||
1257|044|H|or pharmacist.||
1257|045|H|   Do not sunbathe for 24 hours before taking methoxsalen and||
1257|046|H|having the UVA light treatment.||
1257|047|H|   Take this medication by mouth with low fat food or milk as||
1257|048|H|directed by your doctor, usually 90 minutes to 2 hours before||
1257|049|H|your UVA light treatment. Taking methoxsalen with food helps to||
1257|050|H|increase absorption of the medication and also decreases nausea.||
1257|051|H|   The dosage of methoxsalen is based on your weight, medical||
1257|052|H|condition, and response to treatment. The amount and time of UVA||
1257|053|H|light for each treatment is based on your skin type and response||
1257|054|H|to treatment. You may have UVA light treatments 2 to 4 times a||
1257|055|H|week when you first start and then less often as your condition||
1257|056|H|improves.||
1257|057|H|   For 24 hours after taking the capsule, during daylight hours||
1257|058|H|wear wrap-around sunglasses which block out UVA light. This will||
1257|059|H|prevent UVA rays from entering the eyes. UVA light can cause||
1257|060|H|methoxsalen to bind to the lenses of the eyes, causing cataracts.||
1257|061|H|Also, avoid sunlight (including sunlight through windows) on your||
1257|062|H|skin or lips for at least 8 hours after taking methoxsalen. This||
1257|063|H|will prevent the body from getting too much UVA rays which could||
1257|064|H|lead to sunburns. If you cannot avoid sunlight, wear protective||
1257|065|H|clothing (such as hat, gloves, long-sleeved shirt, pants) and/or||
1257|066|H|sunscreen which blocks out UVA light. Consult your doctor or||
1257|067|H|pharmacist for information on which sunscreen to use. Do not||
1257|068|H|apply the sunscreen to areas of the skin affected by psoriasis||
1257|069|H|until after the UVA light treatment.||
1257|070|H|   During the UVA light treatment, follow all instructions given||
1257|071|H|by the healthcare professional. After the UVA light treatment, do||
1257|072|H|not sunbathe for at least 48 hours. Doing so may increase the||
1257|073|H|risk of severe burns. Consult your doctor for more details.||
1257|074|H|   Tell your doctor if your condition does not get better or if||
1257|075|H|it gets worse.||
1257|076|B|||
1257|077|S|SIDE EFFECTS:  Nausea or trouble sleeping may occur with||
1257|078|S|methoxsalen. Mild itching/drying/reddening/darkening of skin may||
1257|079|S|occur when methoxsalen is used along with UVA light treatment. If||
1257|080|S|any of these effects last or get worse, tell your doctor or||
1257|081|S|pharmacist promptly.||
1257|082|S|   If needed, consult your doctor or pharmacist about which||
1257|083|S|products (such as a moisturizer) to use to help treat dry/itchy||
1257|084|S|skin.||
1257|085|S|   Remember that this medication has been prescribed because your||
1257|086|S|doctor has judged that the benefit to you is greater than the||
1257|087|S|risk of side effects. Many people using this medication do not||
1257|088|S|have serious side effects.||
1257|089|S|   Tell your doctor right away if you have any serious side||
1257|090|S|effects, including: severe reddening of skin,||
1257|091|S|blistering/peeling/burning of skin, thinning/wrinkling skin,||
1257|092|S|painful browning/whitening/yellowing of nails, unusual||
1257|093|S|growths/moles/skin sores, swelling ankles, mental/mood changes||
1257|094|S|(such as depression, nervousness), decreased/blurred vision.||
1257|095|S|   A very serious allergic reaction to this drug is rare.||
1257|096|S|However, get medical help right away if you notice any symptoms||
1257|097|S|of a serious allergic reaction, including: rash, itching/swelling||
1257|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1257|099|S|breathing.||
1257|100|S|   This is not a complete list of possible side effects. If you||
1257|101|S|notice other effects not listed above, contact your doctor or||
1257|102|S|pharmacist.||
1257|103|S|   In the US -||
1257|104|S|   Call your doctor for medical advice about side effects. You||
1257|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1257|106|S|www.fda.gov/medwatch.||
1257|107|S|   In Canada - Call your doctor for medical advice about side||
1257|108|S|effects. You may report side effects to Health Canada at||
1257|109|S|1-866-234-2345.||
1257|110|B|||
1257|111|P|PRECAUTIONS:  Before taking methoxsalen, tell your doctor or||
1257|112|P|pharmacist if you are allergic to it; or if you have any other||
1257|113|P|allergies. This product may contain inactive ingredients, which||
1257|114|P|can cause allergic reactions or other problems. Talk to your||
1257|115|P|pharmacist for more details.||
1257|116|P|   Before using this medication, tell your doctor or pharmacist||
1257|117|P|your medical history, especially of: conditions that make you||
1257|118|P|sensitive to light (such as lupus, certain porphyrias, xeroderma||
1257|119|P|pigmentosum, albinism), skin cancer (melanoma, basal cell or||
1257|120|P|squamous cell carcinomas), removal of natural lens in the eye,||
1257|121|P|coal tar/UVB treatment, radiation treatment, arsenic treatment,||
1257|122|P|cataracts, liver disease, heart disease, kidney disease.||
1257|123|P|   Before having surgery, tell your doctor or dentist about all||
1257|124|P|the products you use (including prescription drugs,||
1257|125|P|nonprescription drugs, and herbal products).||
1257|126|P|   Tell your doctor if you are pregnant or plan to become||
1257|127|P|pregnant. You should not become pregnant while using methoxsalen.||
1257|128|P|Methoxsalen may harm an unborn baby. If you become pregnant, talk||
1257|129|P|to your doctor right away about the risks and benefits of this||
1257|130|P|medication.||
1257|131|P|   It is unknown if this medication passes into breast milk.||
1257|132|P|Because of the possible risk to the infant, breastfeeding is not||
1257|133|P|recommended while using this medication. Consult your doctor||
1257|134|P|before breastfeeding.||
1257|135|B|||
1257|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1257|137|I|medications work or increase your risk for serious side effects.||
1257|138|I|This document does not contain all possible drug interactions.||
1257|139|I|Keep a list of all the products you use (including||
1257|140|I|prescription/nonprescription drugs and herbal products) and share||
1257|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
1257|142|I|the dosage of any medicines without your doctor's approval.||
1257|143|I|   A product that may interact with this drug is: fezolinetant.||
1257|144|B|||
1257|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1257|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1257|147|O|poison control center right away. US residents can call||
1257|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1257|149|O|Symptoms of overdose include: severe reddening of skin,||
1257|150|O|blistering/burning/peeling of skin.||
1257|151|B|||
1257|152|N|NOTES:  Do not share this medication with others.||
1257|153|N|   Lab and/or medical tests (such as eye exams, complete blood||
1257|154|N|count, kidney/liver function) should be done while you are taking||
1257|155|N|this medication. Keep all medical and lab appointments. Consult||
1257|156|N|your doctor for more details.||
1257|157|B|||
1257|158|D|MISSED DOSE:  This medication is taken only before a UVA light||
1257|159|D|treatment. If you forget to take your dose as scheduled or miss a||
1257|160|D|treatment, contact your doctor right away to reschedule your||
1257|161|D|treatment.||
1257|162|B|||
1257|163|R|STORAGE:  Store at room temperature away from light and moisture.||
1257|164|R|Do not store in the bathroom. Keep all medications away from||
1257|165|R|children and pets.||
1257|166|R|   Do not flush medications down the toilet or pour them into a||
1257|167|R|drain unless instructed to do so. Properly discard this product||
1257|168|R|when it is expired or no longer needed. Consult your pharmacist||
1257|169|R|or local waste disposal company.||
1257|170|B|||
1257|171|A|Information last revised October 2024.||
1257|172|A|Copyright(c) 2025 First Databank, Inc.||
1257|173|B|||
1258|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1258|002|Z|does NOT have all possible information about this product. This||
1258|003|Z|information does not assure that this product is safe, effective,||
1258|004|Z|or appropriate for you. This information is not individual||
1258|005|Z|medical advice and does not substitute for the advice of your||
1258|006|Z|health care professional. Always ask your health care||
1258|007|Z|professional for complete information about this product and your||
1258|008|Z|specific health needs.||
1258|009|B|||
1258|010|T|MARGETUXIMAB - INJECTION||
1258|011|F|(MAR-je-TUX-i-mab)||
1258|012|B|||
1258|013|C|COMMON BRAND NAME(S): Margenza||
1258|014|B|||
1258|015|W|WARNING:  Margetuximab may lead to serious heart problems,||
1258|016|W|including heart failure. Your doctor will do heart exams before||
1258|017|W|and during treatment with this medication. Tell your doctor right||
1258|018|W|away if you have any symptoms of heart failure, such as new or||
1258|019|W|worsening shortness of breath, swelling ankles/feet, swelling of||
1258|020|W|the face, fast heartbeat, fainting, unusual tiredness, or||
1258|021|W|unusual/sudden weight gain.||
1258|022|W|   Margetuximab may cause serious (possibly fatal) harm to an||
1258|023|W|unborn baby if used during pregnancy. Discuss reliable forms of||
1258|024|W|birth control with your doctor. See also Precautions section.||
1258|025|B|||
1258|026|U|USES:  Margetuximab is used along with other medication(s) to||
1258|027|U|treat breast cancer. Margetuximab belongs to a class of drugs||
1258|028|U|known as monoclonal antibodies. It works by slowing or stopping||
1258|029|U|the growth of cancer cells.||
1258|030|B|||
1258|031|H|HOW TO USE:  This medication is given by slow injection into a||
1258|032|H|vein as directed by your doctor, usually once every 3 weeks. The||
1258|033|H|injection is given by a health care professional. The first||
1258|034|H|injection is given over at least 120 minutes. Later doses may be||
1258|035|H|given over a shorter time (at least 30 minutes).||
1258|036|H|   The dosage, the speed of your injection, and the length of||
1258|037|H|time you receive margetuximab are based on your body weight,||
1258|038|H|medical condition, and response to treatment.||
1258|039|H|   To get the most benefit from this medication, do not miss any||
1258|040|H|doses. To help you remember, mark your calendar with a reminder.||
1258|041|B|||
1258|042|S|SIDE EFFECTS:  See also Warning section.||
1258|043|S|   Dizziness, diarrhea or constipation, abdominal pain, nausea,||
1258|044|S|vomiting, headache, sweating, fast heartbeat, or shortness of||
1258|045|S|breath may occur. Nausea and vomiting can be severe. In some||
1258|046|S|cases, your doctor may prescribe medication to prevent or relieve||
1258|047|S|nausea and vomiting. Eating several small meals, not eating||
1258|048|S|before treatment, or limiting activity may help lessen some of||
1258|049|S|these effects. If any of these effects last or get worse, tell||
1258|050|S|your doctor or pharmacist promptly.||
1258|051|S|   Temporary hair loss may occur. Normal hair growth should||
1258|052|S|return after treatment has ended.||
1258|053|S|   Remember that this medication has been prescribed because your||
1258|054|S|doctor has judged that the benefit to you is greater than the||
1258|055|S|risk of side effects. Many people using this medication do not||
1258|056|S|have serious side effects.||
1258|057|S|   Tell your doctor right away if you have any serious side||
1258|058|S|effects, including: unusual tiredness, muscle/joint pain,||
1258|059|S|numbness/tingling/pain in the arms/legs, pale skin, easy||
1258|060|S|bruising/bleeding.||
1258|061|S|   This medication may lower your ability to fight infections.||
1258|062|S|This may make you more likely to get a serious (rarely fatal)||
1258|063|S|infection or make any infection you have worse. Tell your doctor||
1258|064|S|right away if you have any signs of infection (such as sore||
1258|065|S|throat that doesn't go away, fever, chills).||
1258|066|S|   A very serious allergic reaction to this drug is rare.||
1258|067|S|However, get medical help right away if you notice any symptoms||
1258|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1258|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1258|070|S|breathing.||
1258|071|S|   This is not a complete list of possible side effects. If you||
1258|072|S|notice other effects not listed above, contact your doctor or||
1258|073|S|pharmacist.||
1258|074|S|   In the US -||
1258|075|S|   Call your doctor for medical advice about side effects. You||
1258|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1258|077|S|www.fda.gov/medwatch.||
1258|078|S|   In Canada - Call your doctor for medical advice about side||
1258|079|S|effects. You may report side effects to Health Canada at||
1258|080|S|1-866-234-2345.||
1258|081|B|||
1258|082|P|PRECAUTIONS:  See also Warning section.||
1258|083|P|   Before using margetuximab, tell your doctor or pharmacist if||
1258|084|P|you are allergic to it; or if you have any other allergies. This||
1258|085|P|product may contain inactive ingredients which can cause allergic||
1258|086|P|reactions or other problems. Talk to your pharmacist for more||
1258|087|P|details.||
1258|088|P|   Before using this medication, tell your doctor or pharmacist||
1258|089|P|your medical history, especially of: recent/current infection,||
1258|090|P|heart disease.||
1258|091|P|   Margetuximab can make you more likely to get infections or may||
1258|092|P|make current infections worse. Stay away from anyone who has an||
1258|093|P|infection that may easily spread (such as chickenpox, COVID-19,||
1258|094|P|measles, flu). Talk to your doctor if you have been exposed to an||
1258|095|P|infection or for more details.||
1258|096|P|   Tell your health care professional that you are using||
1258|097|P|margetuximab before having any immunizations/vaccinations. Avoid||
1258|098|P|contact with people who have recently received live vaccines||
1258|099|P|(such as flu vaccine inhaled through the nose).||
1258|100|P|   To lower the chance of getting cut, bruised, or injured, use||
1258|101|P|caution with sharp objects like razors and nail cutters, and||
1258|102|P|avoid activities such as contact sports.||
1258|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1258|104|P|can make you more dizzy. Do not drive, use machinery, or do||
1258|105|P|anything that needs alertness until you can do it safely. Limit||
1258|106|P|alcoholic beverages. Talk to your doctor if you are using||
1258|107|P|marijuana (cannabis).||
1258|108|P|   Before having surgery, tell your doctor or dentist about all||
1258|109|P|the products you use (including prescription drugs,||
1258|110|P|nonprescription drugs, and herbal products).||
1258|111|P|   Tell your doctor if you are pregnant or plan to become||
1258|112|P|pregnant. You should not become pregnant while using||
1258|113|P|margetuximab. Margetuximab may harm an unborn baby. Your doctor||
1258|114|P|should order a pregnancy test before you start this medication.||
1258|115|P|Ask about reliable forms of birth control while using this||
1258|116|P|medication and for 4 months after the last dose. If you become||
1258|117|P|pregnant, talk to your doctor right away about the risks and||
1258|118|P|benefits of this medication.||
1258|119|P|   It is unknown if this drug passes into breast milk. Consult||
1258|120|P|your doctor before breastfeeding.||
1258|121|B|||
1258|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1258|123|I|medications work or increase your risk for serious side effects.||
1258|124|I|This document does not contain all possible drug interactions.||
1258|125|I|Keep a list of all the products you use (including||
1258|126|I|prescription/nonprescription drugs and herbal products) and share||
1258|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
1258|128|I|the dosage of any medicines without your doctor's approval.||
1258|129|B|||
1258|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1258|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1258|132|O|poison control center right away. US residents can call||
1258|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1258|134|B|||
1258|135|N|NOTES:  Lab and/or medical tests (such as heart exams, complete||
1258|136|N|blood counts, liver function) should be done before you start||
1258|137|N|using this medication and while you are using it. Keep all||
1258|138|N|medical and lab appointments. Consult your doctor for more||
1258|139|N|details.||
1258|140|B|||
1258|141|D|MISSED DOSE:  It is important to get each dose of this medication||
1258|142|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1258|143|D|right away for a new dosing schedule.||
1258|144|B|||
1258|145|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1258|146|R|hospital and will not be stored at home.||
1258|147|B|||
1258|148|M|MEDICAL ALERT:  Your condition can cause complications in a||
1258|149|M|medical emergency. For information about enrolling in MedicAlert,||
1258|150|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1258|151|B|||
1258|152|A|Information last revised April 2025.||
1258|153|A|Copyright(c) 2025 First Databank, Inc.||
1258|154|B|||
1259|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1259|002|Z|does NOT have all possible information about this product. This||
1259|003|Z|information does not assure that this product is safe, effective,||
1259|004|Z|or appropriate for you. This information is not individual||
1259|005|Z|medical advice and does not substitute for the advice of your||
1259|006|Z|health care professional. Always ask your health care||
1259|007|Z|professional for complete information about this product and your||
1259|008|Z|specific health needs.||
1259|009|B|||
1259|010|T|CASIMERSEN - INJECTION||
1259|011|F|(KAS-i-MER-sen)||
1259|012|B|||
1259|013|C|COMMON BRAND NAME(S): Amondys 45||
1259|014|B|||
1259|015|U|USES:  Casimersen is used to treat a certain inherited muscle||
1259|016|U|disorder (Duchenne muscular dystrophy-DMD). This disorder is||
1259|017|U|caused by a lack of a certain muscle protein (dystrophin). This||
1259|018|U|medication can increase the amount of dystrophin in your body.||
1259|019|B|||
1259|020|H|HOW TO USE:  This medication is given by injection into a vein by||
1259|021|H|a health care professional as directed by your doctor. It is||
1259|022|H|usually given once every week over 35 to 60 minutes. The dosage||
1259|023|H|is based on your weight.||
1259|024|H|   Tell your doctor if your condition does not get better or if||
1259|025|H|it gets worse.||
1259|026|B|||
1259|027|S|SIDE EFFECTS:  Nausea, dizziness, or joint pain may occur. If any||
1259|028|S|of these effects last or get worse, tell your doctor or||
1259|029|S|pharmacist promptly.||
1259|030|S|   Remember that this medication has been prescribed because your||
1259|031|S|doctor has judged that the benefit to you is greater than the||
1259|032|S|risk of side effects. Many people using this medication do not||
1259|033|S|have serious side effects.||
1259|034|S|   Tell your doctor right away if you have any serious side||
1259|035|S|effects, including: signs of kidney problems (such as a change in||
1259|036|S|the amount of urine), signs of infection (such as sore throat||
1259|037|S|that doesn't go away, fever, chills, cough, shortness of breath),||
1259|038|S|ear pain.||
1259|039|S|   A very serious allergic reaction to this drug is rare.||
1259|040|S|However, get medical help right away if you notice any symptoms||
1259|041|S|of a serious allergic reaction, including: rash, itching/swelling||
1259|042|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1259|043|S|breathing.||
1259|044|S|   This is not a complete list of possible side effects. If you||
1259|045|S|notice other effects not listed above, contact your doctor or||
1259|046|S|pharmacist.||
1259|047|S|   In the US -||
1259|048|S|   Call your doctor for medical advice about side effects. You||
1259|049|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1259|050|S|www.fda.gov/medwatch.||
1259|051|S|   In Canada - Call your doctor for medical advice about side||
1259|052|S|effects. You may report side effects to Health Canada at||
1259|053|S|1-866-234-2345.||
1259|054|B|||
1259|055|P|PRECAUTIONS:  Before using casimersen, tell your doctor or||
1259|056|P|pharmacist if you are allergic to it; or if you have any other||
1259|057|P|allergies. This product may contain inactive ingredients, which||
1259|058|P|can cause allergic reactions or other problems. Talk to your||
1259|059|P|pharmacist for more details.||
1259|060|P|   Before using this medication, tell your doctor or pharmacist||
1259|061|P|your medical history, especially of: kidney problems.||
1259|062|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1259|063|P|can worsen these effects. Do not drive, use machinery, or do||
1259|064|P|anything that needs alertness until you can do it safely. Limit||
1259|065|P|alcoholic beverages. Talk to your doctor if you are using||
1259|066|P|marijuana (cannabis).||
1259|067|P|   Before having surgery, tell your doctor or dentist about all||
1259|068|P|the products you use (including prescription drugs,||
1259|069|P|nonprescription drugs, and herbal products).||
1259|070|P|   During pregnancy, this medication should be used only when||
1259|071|P|clearly needed. Discuss the risks and benefits with your doctor.||
1259|072|P|   It is unknown if this drug passes into breast milk. Consult||
1259|073|P|your doctor before breastfeeding.||
1259|074|B|||
1259|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1259|076|I|medications work or increase your risk for serious side effects.||
1259|077|I|This document does not contain all possible drug interactions.||
1259|078|I|Keep a list of all the products you use (including||
1259|079|I|prescription/nonprescription drugs and herbal products) and share||
1259|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
1259|081|I|the dosage of any medicines without your doctor's approval.||
1259|082|B|||
1259|083|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1259|084|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1259|085|O|poison control center right away. US residents can call||
1259|086|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1259|087|B|||
1259|088|N|NOTES:  Lab and/or medical tests (such as kidney function) should||
1259|089|N|be done before you start using this medication and while you are||
1259|090|N|using it. Keep all medical and lab appointments. Consult your||
1259|091|N|doctor for more details.||
1259|092|B|||
1259|093|D|MISSED DOSE:  It is important to get each dose of this medication||
1259|094|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1259|095|D|right away for a new dosing schedule.||
1259|096|B|||
1259|097|R|STORAGE:  Not applicable. This medication is given in a clinic||
1259|098|R|and will not be stored at home.||
1259|099|B|||
1259|100|A|Information last revised April 2025.||
1259|101|A|Copyright(c) 2025 First Databank, Inc.||
1259|102|B|||
1260|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1260|002|Z|does NOT have all possible information about this product. This||
1260|003|Z|information does not assure that this product is safe, effective,||
1260|004|Z|or appropriate for you. This information is not individual||
1260|005|Z|medical advice and does not substitute for the advice of your||
1260|006|Z|health care professional. Always ask your health care||
1260|007|Z|professional for complete information about this product and your||
1260|008|Z|specific health needs.||
1260|009|B|||
1260|010|T|FOSDENOPTERIN - INJECTION||
1260|011|F|(FOS-den-OP-ter-in)||
1260|012|B|||
1260|013|C|COMMON BRAND NAME(S): Nulibry||
1260|014|B|||
1260|015|U|USES:  This medication is used to improve survival from a certain||
1260|016|U|genetic disorder (molybdenum cofactor deficiency-MoCD Type A).||
1260|017|U|Fosdenopterin replaces a certain substance that is missing in||
1260|018|U|people with MoCD Type A.||
1260|019|B|||
1260|020|H|HOW TO USE:  Read the Instructions for Use if available from the||
1260|021|H|pharmacist before your child starts using fosdenopterin and each||
1260|022|H|time you get a refill. If you have any questions, ask the doctor||
1260|023|H|or pharmacist.||
1260|024|H|   This medication is given by injection into a vein as directed||
1260|025|H|by your child's doctor, usually once a day.||
1260|026|H|   If you are using this medication at home, learn all||
1260|027|H|preparation and usage instructions from the health care||
1260|028|H|professional. The medication in the vial and the supplies that||
1260|029|H|come with the medication should be used only once. Do not reuse.||
1260|030|H|Take fosdenopterin out of the freezer 30 minutes before use to||
1260|031|H|allow it to reach room temperature. You may also gently roll the||
1260|032|H|vial in between your hands for 3 to 5 minutes. The solution used||
1260|033|H|to mix the medication should also be at room temperature. After||
1260|034|H|adding the solution to the powder, gently swirl the mixture to||
1260|035|H|completely dissolve the powder. Do not shake. Before using, check||
1260|036|H|this product for particles or discoloration. If either is||
1260|037|H|present, do not use the liquid. Learn how to store and discard||
1260|038|H|medical supplies safely.||
1260|039|H|   Use this medication regularly to get the most benefit from it.||
1260|040|H|To help you remember, use it at the same time each day.||
1260|041|H|   Do not increase the dose or use this drug more often or for||
1260|042|H|longer than prescribed. Your child's condition will not improve||
1260|043|H|any faster, and your child's risk of side effects will increase.||
1260|044|H|   Tell the doctor if your child's condition gets worse.||
1260|045|B|||
1260|046|S|SIDE EFFECTS:  Redness, pain, or swelling at the injection site||
1260|047|S|may occur. If any of these effects last or get worse, tell the||
1260|048|S|doctor or pharmacist promptly.||
1260|049|S|   Remember that this medication has been prescribed because the||
1260|050|S|doctor has judged that the benefit to your child is greater than||
1260|051|S|the risk of side effects. Many people using this medication do||
1260|052|S|not have serious side effects.||
1260|053|S|   Tell the doctor right away if your child has any serious side||
1260|054|S|effects, including: skin blisters/redness.||
1260|055|S|   A very serious allergic reaction to this drug is rare.||
1260|056|S|However, get medical help right away if you notice any symptoms||
1260|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1260|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1260|059|S|breathing.||
1260|060|S|   This is not a complete list of possible side effects. If you||
1260|061|S|notice other effects not listed above, contact your doctor or||
1260|062|S|pharmacist.||
1260|063|S|   In the US -||
1260|064|S|   Call your doctor for medical advice about side effects. You||
1260|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1260|066|S|www.fda.gov/medwatch.||
1260|067|S|   In Canada - Call your doctor for medical advice about side||
1260|068|S|effects. You may report side effects to Health Canada at||
1260|069|S|1-866-234-2345.||
1260|070|B|||
1260|071|P|PRECAUTIONS:  Before using fosdenopterin, tell the doctor or||
1260|072|P|pharmacist if your child is allergic to it; or if your child has||
1260|073|P|any other allergies. This product may contain inactive||
1260|074|P|ingredients, which can cause allergic reactions or other||
1260|075|P|problems. Talk to the pharmacist for more details.||
1260|076|P|   Before using this medication, tell your child's doctor or||
1260|077|P|pharmacist your child's medical history.||
1260|078|P|   This medication may make your child more sensitive to the sun.||
1260|079|P|Limit your child's time in the sun. Avoid tanning booths and||
1260|080|P|sunlamps. Use sunscreen and wear protective clothing when||
1260|081|P|outdoors. Tell the doctor right away if your child gets sunburned||
1260|082|P|or has skin blisters/redness. The doctor may direct your child to||
1260|083|P|limit or avoid phototherapy while your child uses this product.||
1260|084|P|Ask the doctor for details.||
1260|085|P|   Before having surgery, tell the doctor or dentist about all||
1260|086|P|the products your child uses (including prescription drugs,||
1260|087|P|nonprescription drugs, and herbal products).||
1260|088|P|   This medication is not usually used by adults. It is unlikely||
1260|089|P|to be used during pregnancy or breastfeeding. Consult your doctor||
1260|090|P|if you have any questions about this medication.||
1260|091|B|||
1260|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1260|093|I|medications work or increase your risk for serious side effects.||
1260|094|I|This document does not contain all possible drug interactions.||
1260|095|I|Keep a list of all the products you use (including||
1260|096|I|prescription/nonprescription drugs and herbal products) and share||
1260|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
1260|098|I|the dosage of any medicines without your doctor's approval.||
1260|099|B|||
1260|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1260|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1260|102|O|poison control center right away. US residents can call||
1260|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1260|104|B|||
1260|105|N|NOTES:  Do not share this medication with others.||
1260|106|B|||
1260|107|D|MISSED DOSE:  It is important that your child gets each dose of||
1260|108|D|this medication as scheduled. If your child misses a dose, give||
1260|109|D|it as soon as you remember. Make sure there are at least 6 hours||
1260|110|D|between the missed dose and the next scheduled dose. Do not||
1260|111|D|double the dose to catch up.||
1260|112|B|||
1260|113|R|STORAGE:  Store the unmixed vial in the freezer. Keep the vial in||
1260|114|R|the original carton to protect from light. The mixing solution||
1260|115|R|may be kept at room temperature. After mixing, use this||
1260|116|R|medication right away or within 4 hours. Do not freeze the mixed||
1260|117|R|solution. Discard any unused portion. Keep all medications away||
1260|118|R|from children and pets.||
1260|119|R|   Do not flush medications down the toilet or pour them into a||
1260|120|R|drain unless instructed to do so. Properly discard this product||
1260|121|R|when it is expired or no longer needed. Consult your pharmacist||
1260|122|R|or local waste disposal company.||
1260|123|B|||
1260|124|A|Information last revised November 2024.||
1260|125|A|Copyright(c) 2025 First Databank, Inc.||
1260|126|B|||
1262|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1262|002|Z|does NOT have all possible information about this product. This||
1262|003|Z|information does not assure that this product is safe, effective,||
1262|004|Z|or appropriate for you. This information is not individual||
1262|005|Z|medical advice and does not substitute for the advice of your||
1262|006|Z|health care professional. Always ask your health care||
1262|007|Z|professional for complete information about this product and your||
1262|008|Z|specific health needs.||
1262|009|B|||
1262|010|T|NYSTATIN/METRONIDAZOLE OVULE - VAGINAL||
1262|011|F|(NYE-stat-in/meh-trow-NID-uh-zole)||
1262|012|B|||
1262|013|U|USES:  This product is used to treat certain types of vaginal||
1262|014|U|infections (such as mixed fungal and bacterial infections). It is||
1262|015|U|a combination of 2 medications, nystatin and metronidazole.||
1262|016|U|Nystatin is an antifungal that stops the growth of fungus.||
1262|017|U|Metronidazole is an antibiotic that stops the growth of certain||
1262|018|U|bacteria (Trichomonas-type). This product helps to reduce itching||
1262|019|U|and irritating discharge.||
1262|020|B|||
1262|021|H|HOW TO USE:  This product is for vaginal use only. Using the||
1262|022|H|applicator, insert 1 ovule deep into the vagina as directed by||
1262|023|H|your doctor, usually once daily before bedtime for 10 days.||
1262|024|H|   Wash hands before and after using this medication. Follow the||
1262|025|H|manufacturer's directions for placing an ovule into the||
1262|026|H|applicator. Insert the applicator high into the vagina and press||
1262|027|H|the plunger to release the medication. After each use, clean the||
1262|028|H|applicator with warm soapy water and rinse well.||
1262|029|H|   Do not drink alcohol while using this medication and for at||
1262|030|H|least 24 hours after stopping the medication. Drinking alcohol||
1262|031|H|while using this medication may cause stomach cramps, flushing,||
1262|032|H|nausea, vomiting, and headache.||
1262|033|H|   Continue to use this product until the full prescribed amount||
1262|034|H|is finished, even if symptoms disappear after a few days.||
1262|035|H|Stopping the product too early may result in a return of the||
1262|036|H|infection.||
1262|037|H|   Tell your doctor if your symptoms get worse or if they do not||
1262|038|H|get better within 10 days. You may require additional medication||
1262|039|H|to treat your condition.||
1262|040|H|   Your sexual partner may also require medication to prevent||
1262|041|H|re-infection. Consult your doctor.||
1262|042|B|||
1262|043|S|SIDE EFFECTS:  Vaginal burning/itching, gritty feeling in the||
1262|044|S|vagina, bitter taste in the mouth, stomach pain, or nausea may||
1262|045|S|occur. If any of these effects last or get worse, tell your||
1262|046|S|doctor or pharmacist promptly.||
1262|047|S|   Remember that this medication has been prescribed because your||
1262|048|S|doctor has judged that the benefit to you is greater than the||
1262|049|S|risk of side effects. Many people using this medication do not||
1262|050|S|have serious side effects.||
1262|051|S|   Get medical help right away if you have any very serious side||
1262|052|S|effects, including: seizures, tingling/numbness of the||
1262|053|S|hands/feet.||
1262|054|S|   A very serious allergic reaction to this drug is rare.||
1262|055|S|However, get medical help right away if you notice any symptoms||
1262|056|S|of a serious allergic reaction, including: fever that doesn't go||
1262|057|S|away, new or worsening lymph node swelling, rash,||
1262|058|S|itching/swelling (especially of the face/tongue/throat), severe||
1262|059|S|dizziness, trouble breathing.||
1262|060|S|   This is not a complete list of possible side effects. If you||
1262|061|S|notice other effects not listed above, contact your doctor or||
1262|062|S|pharmacist.||
1262|063|S|   In the US -||
1262|064|S|   Call your doctor for medical advice about side effects. You||
1262|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1262|066|S|www.fda.gov/medwatch.||
1262|067|S|   In Canada - Call your doctor for medical advice about side||
1262|068|S|effects. You may report side effects to Health Canada at||
1262|069|S|1-866-234-2345.||
1262|070|B|||
1262|071|P|PRECAUTIONS:  Before using nystatin/metronidazole, tell your||
1262|072|P|doctor or pharmacist if you are allergic to it; or if you have||
1262|073|P|any other allergies. This product may contain inactive||
1262|074|P|ingredients, which can cause allergic reactions or other||
1262|075|P|problems. Talk to your pharmacist for more details.||
1262|076|P|   Before using this medication, tell your doctor or pharmacist||
1262|077|P|your medical history, especially of: seizure disorders, liver||
1262|078|P|disease, nervous system problems, blood disorders.||
1262|079|P|   During pregnancy, this medication should be used only when||
1262|080|P|clearly needed. Antibiotics taken by mouth have been used to||
1262|081|P|treat vaginal infections during pregnancy (especially pregnancies||
1262|082|P|with problems such as risk of early childbirth). Consult your||
1262|083|P|doctor for more details and to discuss the risks and benefits.||
1262|084|P|   It is unknown if nystatin or metronidazole passes into breast||
1262|085|P|milk. Consult your doctor before breastfeeding.||
1262|086|B|||
1262|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1262|088|I|medications work or increase your risk for serious side effects.||
1262|089|I|This document does not contain all possible drug interactions.||
1262|090|I|Keep a list of all the products you use (including||
1262|091|I|prescription/nonprescription drugs and herbal products) and share||
1262|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
1262|093|I|the dosage of any medicines without your doctor's approval.||
1262|094|I|   Do not use this medication if you have taken disulfiram within||
1262|095|I|the last 2 weeks.||
1262|096|I|   Do not take products containing alcohol or propylene glycol||
1262|097|I|while using this medication and for at least 24 hours after||
1262|098|I|stopping this medication. Ask your pharmacist for more details.||
1262|099|I|   This medication may interfere with certain lab tests, possibly||
1262|100|I|causing false test results. Make sure lab personnel and all your||
1262|101|I|doctors know you use this drug.||
1262|102|B|||
1262|103|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1262|104|O|has overdosed and has serious symptoms such as passing out or||
1262|105|O|trouble breathing, call 911. Otherwise, call a poison control||
1262|106|O|center right away. US residents can call 1-800-222-1222. Canada||
1262|107|O|residents can call 1-844-764-7669.||
1262|108|B|||
1262|109|N|NOTES:  Do not share this medication with others.||
1262|110|N|   This medication has been prescribed for your current condition||
1262|111|N|only. Do not use it later for another infection unless your||
1262|112|N|doctor tells you to.||
1262|113|B|||
1262|114|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1262|115|D|If it is near the time of the next dose, skip the missed dose.||
1262|116|D|Use your next dose at the regular time. Do not double the dose to||
1262|117|D|catch up.||
1262|118|B|||
1262|119|R|STORAGE:  Store at room temperature away from light. Keep all||
1262|120|R|medications away from children and pets.||
1262|121|R|   Do not flush medications down the toilet or pour them into a||
1262|122|R|drain unless instructed to do so. Properly discard this product||
1262|123|R|when it is expired or no longer needed. Consult your pharmacist||
1262|124|R|or local waste disposal company.||
1262|125|B|||
1262|126|A|Information last revised January 2025.||
1262|127|A|Copyright(c) 2025 First Databank, Inc.||
1262|128|B|||
1263|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1263|002|Z|does NOT have all possible information about this product. This||
1263|003|Z|information does not assure that this product is safe, effective,||
1263|004|Z|or appropriate for you. This information is not individual||
1263|005|Z|medical advice and does not substitute for the advice of your||
1263|006|Z|health care professional. Always ask your health care||
1263|007|Z|professional for complete information about this product and your||
1263|008|Z|specific health needs.||
1263|009|B|||
1263|010|T|TIVOZANIB - ORAL||
1263|011|F|(tye-VOE-za-nib)||
1263|012|B|||
1263|013|C|COMMON BRAND NAME(S): Fotivda||
1263|014|B|||
1263|015|U|USES:  Tivozanib is used to treat kidney cancer. This medication||
1263|016|U|belongs to a class of drugs known as kinase inhibitors. It works||
1263|017|U|by slowing or stopping the growth of cancer cells.||
1263|018|B|||
1263|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1263|020|H|from your pharmacist before you start taking tivozanib and each||
1263|021|H|time you get a refill. If you have any questions, ask your doctor||
1263|022|H|or pharmacist.||
1263|023|H|   Take this medication by mouth with or without food as directed||
1263|024|H|by your doctor, usually one time each day for 21 days, followed||
1263|025|H|by 7 days off treatment. Repeat this treatment cycle for as long||
1263|026|H|as directed by your doctor. Swallow the capsule whole with a||
1263|027|H|glass of water. Do not open the capsule.||
1263|028|H|   The dosage is based on your medical condition and response to||
1263|029|H|treatment. Do not increase your dose or use this drug more often||
1263|030|H|or for longer than prescribed. Your condition will not improve||
1263|031|H|any faster, and your risk of serious side effects will increase.||
1263|032|H|   Use this medication regularly to get the most benefit from it.||
1263|033|H|To help you remember, take it at the same time each treatment||
1263|034|H|day.||
1263|035|H|   Since this drug can be absorbed through the skin and lungs and||
1263|036|H|may harm an unborn baby, women who are pregnant or who may become||
1263|037|H|pregnant should not handle this medication or breathe the dust||
1263|038|H|from the capsules.||
1263|039|B|||
1263|040|S|SIDE EFFECTS:  Tiredness, nausea/vomiting, diarrhea, loss of||
1263|041|S|appetite, mouth sores, weight loss, voice changes (hoarseness),||
1263|042|S|or cough may occur. If any of these effects last or get worse,||
1263|043|S|tell your doctor or pharmacist promptly.||
1263|044|S|   People using this medication may have serious side effects.||
1263|045|S|However, you have been prescribed this drug because your doctor||
1263|046|S|has judged that the benefit to you is greater than the risk of||
1263|047|S|side effects. Careful monitoring by your doctor may decrease your||
1263|048|S|risk.||
1263|049|S|   This medication may raise your blood pressure. Check your||
1263|050|S|blood pressure regularly and tell your doctor if the results are||
1263|051|S|high. Your doctor may control your blood pressure with||
1263|052|S|medication.||
1263|053|S|   Treatment with this drug may sometimes cause your hands/feet||
1263|054|S|to develop a skin reaction called hand-foot syndrome. Tell your||
1263|055|S|doctor right away if you experience swelling, pain, redness,||
1263|056|S|blisters, or tingling/burning of the hands/feet. Depending on how||
1263|057|S|severe your hand-foot syndrome is, your doctor may give you an||
1263|058|S|additional medication to reduce the symptoms, or may stop or||
1263|059|S|delay your tivozanib treatment.||
1263|060|S|   This medication can affect how your thyroid works. Tell your||
1263|061|S|doctor right away if you have signs of an underactive thyroid||
1263|062|S|(such as weight gain, cold intolerance, slow heartbeat,||
1263|063|S|constipation, or unusual tiredness) or signs of an overactive||
1263|064|S|thyroid (such as mental/mood changes, heat intolerance, unusual||
1263|065|S|weight loss).||
1263|066|S|   Tell your doctor right away if you have any serious side||
1263|067|S|effects, including: easy bruising/bleeding, slow wound healing,||
1263|068|S|signs of kidney problems (such as change in the amount of urine),||
1263|069|S|signs of infection (such as sore throat that doesn't go away,||
1263|070|S|fever, chills), signs of heart failure (such as shortness of||
1263|071|S|breath, swelling ankles/feet, unusual tiredness), signs of liver||
1263|072|S|disease (such as nausea/vomiting that doesn't stop,||
1263|073|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
1263|074|S|of a serious tear in the stomach or intestinal wall (such as||
1263|075|S|severe stomach/abdominal pain that doesn't go away).||
1263|076|S|   Get medical help right away if you have any very serious side||
1263|077|S|effects, including: chest/jaw/left arm pain, unusual sweating,||
1263|078|S|vomit that looks like coffee grounds, black/bloody stools,||
1263|079|S|weakness on one side of the body, trouble speaking.||
1263|080|S|   Rarely, tivozanib may cause a condition known as reversible||
1263|081|S|posterior leukoencephalopathy syndrome-RPLS. Get medical help||
1263|082|S|right away if you develop a headache that doesn't go away,||
1263|083|S|seizures, sudden vision changes, or mental/mood changes (such as||
1263|084|S|confusion).||
1263|085|S|   Tivozanib can commonly cause a rash that is usually not||
1263|086|S|serious. However, you may not be able to tell it apart from a||
1263|087|S|rare rash that could be a sign of a severe reaction. Get medical||
1263|088|S|help right away if you develop any rash.||
1263|089|S|   A very serious allergic reaction to this drug is rare.||
1263|090|S|However, get medical help right away if you notice any symptoms||
1263|091|S|of a serious allergic reaction, including: rash, itching/swelling||
1263|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1263|093|S|breathing.||
1263|094|S|   This is not a complete list of possible side effects. If you||
1263|095|S|notice other effects not listed above, contact your doctor or||
1263|096|S|pharmacist.||
1263|097|S|   In the US -||
1263|098|S|   Call your doctor for medical advice about side effects. You||
1263|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1263|100|S|www.fda.gov/medwatch.||
1263|101|S|   In Canada - Call your doctor for medical advice about side||
1263|102|S|effects. You may report side effects to Health Canada at||
1263|103|S|1-866-234-2345.||
1263|104|B|||
1263|105|P|PRECAUTIONS:  Before taking tivozanib, tell your doctor or||
1263|106|P|pharmacist if you are allergic to it; or if you have any other||
1263|107|P|allergies. This product may contain inactive ingredients, which||
1263|108|P|can cause allergic reactions or other problems. Talk to your||
1263|109|P|pharmacist for more details.||
1263|110|P|   Before using this medication, tell your doctor or pharmacist||
1263|111|P|your medical history, especially of: bleeding problems, recent||
1263|112|P|surgery/injury, heart problems (such as heart failure, previous||
1263|113|P|heart attack), high blood pressure, kidney problems, liver||
1263|114|P|problems.||
1263|115|P|   Before having surgery, tell your doctor or dentist about all||
1263|116|P|the products you use (including prescription drugs,||
1263|117|P|nonprescription drugs, and herbal products).||
1263|118|P|   This medication may cause wounds to heal slowly or poorly.||
1263|119|P|Before having surgery, talk with your doctor or dentist about the||
1263|120|P|risks and benefits of this medication. Your doctor/dentist may||
1263|121|P|tell you to temporarily stop treatment with this medication at||
1263|122|P|least 24 days before surgery. Ask your doctor/dentist for||
1263|123|P|specific instructions about when to stop and when to restart||
1263|124|P|treatment with this medication. Tell your doctor/dentist right||
1263|125|P|away if you have wounds that are not healing well.||
1263|126|P|   Since this drug can be absorbed through the skin and lungs and||
1263|127|P|may harm an unborn baby, women who are pregnant or who may become||
1263|128|P|pregnant should not handle this medication or breathe the dust||
1263|129|P|from the tablets.||
1263|130|P|   Tell your doctor if you are pregnant or plan to become||
1263|131|P|pregnant. You should not become pregnant while using tivozanib.||
1263|132|P|Tivozanib may harm an unborn baby. Your doctor should order a||
1263|133|P|pregnancy test before you start this medication. Men and women||
1263|134|P|using this medication should ask about reliable forms of birth||
1263|135|P|control during treatment and for 1 month after the last dose. If||
1263|136|P|you or your partner becomes pregnant, talk to your doctor right||
1263|137|P|away about the risks and benefits of this medication.||
1263|138|P|   It is unknown if this drug passes into breast milk. Because of||
1263|139|P|the possible risk to the infant, breastfeeding is not recommended||
1263|140|P|while using this drug and for 1 month after the last dose.||
1263|141|P|Consult your doctor before breastfeeding.||
1263|142|B|||
1263|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1263|144|I|medications work or increase your risk for serious side effects.||
1263|145|I|This document does not contain all possible drug interactions.||
1263|146|I|Keep a list of all the products you use (including||
1263|147|I|prescription/nonprescription drugs and herbal products) and share||
1263|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
1263|149|I|the dosage of any medicines without your doctor's approval.||
1263|150|I|   Other medications can affect the removal of tivozanib from||
1263|151|I|your body, which may affect how tivozanib works. Examples include||
1263|152|I|rifamycins (such as rifampin, rifabutin), St. John's wort, drugs||
1263|153|I|used to treat seizures (such as carbamazepine, phenytoin), among||
1263|154|I|others.||
1263|155|B|||
1263|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1263|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1263|158|O|poison control center right away. US residents can call||
1263|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1263|160|B|||
1263|161|N|NOTES:  Do not share this medication with others.||
1263|162|N|   Lab and/or medical tests (such as blood pressure,||
1263|163|N|kidney/liver/thyroid function, complete blood count) should be||
1263|164|N|done while you are taking this medication. Keep all medical and||
1263|165|N|lab appointments.||
1263|166|B|||
1263|167|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1263|168|D|next dose at the regular time. Do not take 2 doses in the same||
1263|169|D|day. Do not double the dose to catch up.||
1263|170|B|||
1263|171|R|STORAGE:  Store at room temperature away from light and moisture.||
1263|172|R|Do not store in the bathroom. Keep all medications away from||
1263|173|R|children and pets.||
1263|174|R|   Do not flush medications down the toilet or pour them into a||
1263|175|R|drain unless instructed to do so. Properly discard this product||
1263|176|R|when it is expired or no longer needed. Consult your pharmacist||
1263|177|R|or local waste disposal company.||
1263|178|B|||
1263|179|M|MEDICAL ALERT:  Your condition can cause complications in a||
1263|180|M|medical emergency. For information about enrolling in MedicAlert,||
1263|181|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1263|182|B|||
1263|183|A|Information last revised August 2024.||
1263|184|A|Copyright(c) 2025 First Databank, Inc.||
1263|185|B|||
1265|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1265|002|Z|does NOT have all possible information about this product. This||
1265|003|Z|information does not assure that this product is safe, effective,||
1265|004|Z|or appropriate for you. This information is not individual||
1265|005|Z|medical advice and does not substitute for the advice of your||
1265|006|Z|health care professional. Always ask your health care||
1265|007|Z|professional for complete information about this product and your||
1265|008|Z|specific health needs.||
1265|009|B|||
1265|010|T|HYDROCODONE/CHLORPHENIRAMINE POLISTIREX ER SUSPENSION - ORAL||
1265|011|F|(HYE-droe-KOE-done/KLOR-fen-IR-a-meen/POL-ee-STYE-rex)||
1265|012|B|||
1265|013|C|COMMON BRAND NAME(S): Tussionex||
1265|014|B|||
1265|015|W|WARNING:  This medication has a risk for abuse and addiction,||
1265|016|W|which can lead to overdose and death. This medication may also||
1265|017|W|cause severe, possibly fatal, breathing problems. To lower your||
1265|018|W|risk, your doctor should have you take the smallest dose that||
1265|019|W|works, and take it for the shortest possible time. See also How||
1265|020|W|to Use section for more information about addiction.||
1265|021|W|   The risk for severe breathing problems is higher when you||
1265|022|W|start this medication, or if you take the wrong dose or take more||
1265|023|W|of this medication than prescribed. Taking this medication with||
1265|024|W|alcohol or other drugs that can cause drowsiness or breathing||
1265|025|W|problems may cause very serious side effects, including death.||
1265|026|W|Also, other medications can affect the removal of this product||
1265|027|W|from your body, which may affect how it works. Be sure you know||
1265|028|W|how to take this product and what other drugs you should avoid||
1265|029|W|taking with it. See also Drug Interactions section. Get medical||
1265|030|W|help right away if any of these very serious side effects occur:||
1265|031|W|slow/shallow breathing, unusual lightheadedness, severe||
1265|032|W|drowsiness/dizziness, difficulty waking up.||
1265|033|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1265|034|W|or abuse. If someone accidentally swallows this drug, get medical||
1265|035|W|help right away.||
1265|036|W|   Before using this medication, women of childbearing age should||
1265|037|W|talk with their doctor(s) about the risks and benefits. Tell your||
1265|038|W|doctor if you are pregnant or think you may be pregnant. During||
1265|039|W|pregnancy, this medication is not recommended. It may slightly||
1265|040|W|increase the risk of birth defects if used during the first two||
1265|041|W|months of pregnancy. Also, using it for a long time or in high||
1265|042|W|doses near the expected delivery date may harm the unborn baby.||
1265|043|W|To lessen the risk, take the smallest effective dose for the||
1265|044|W|shortest possible time. Babies born to mothers who use this drug||
1265|045|W|for a long time may develop severe (possibly fatal) withdrawal||
1265|046|W|symptoms. Tell the doctor right away if you notice any symptoms||
1265|047|W|in your newborn baby such as crying that doesn't stop,||
1265|048|W|slow/shallow breathing, irritability, shaking, vomiting,||
1265|049|W|diarrhea, poor feeding, or difficulty gaining weight.||
1265|050|B|||
1265|051|U|USES:  This combination product is used to treat coughs and other||
1265|052|U|symptoms caused by the common cold or allergies. This product||
1265|053|U|contains 2 medications: hydrocodone and chlorpheniramine.||
1265|054|U|Hydrocodone is an opioid cough suppressant (antitussive) that||
1265|055|U|acts on a certain part of the brain (cough center) to reduce the||
1265|056|U|urge to cough. Chlorpheniramine is an antihistamine that helps to||
1265|057|U|relieve watery eyes, itchy eyes/nose/throat, runny nose, and||
1265|058|U|sneezing.||
1265|059|U|   Opioid cough suppressants should not be used by children||
1265|060|U|younger than 18 years. Children are at higher risk for serious||
1265|061|U|(even fatal) side effects, especially breathing problems. Talk||
1265|062|U|with the doctor about the risks and benefits of this medication.||
1265|063|U|   Cough-and-cold products do not cure colds. Cough due to a||
1265|064|U|common cold often does not need to be treated with medicine. Ask||
1265|065|U|your doctor or pharmacist about other ways to relieve cough and||
1265|066|U|cold symptoms, such as drinking enough fluids, using a||
1265|067|U|humidifier, or saline nose drops/spray.||
1265|068|B|||
1265|069|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1265|070|H|Patient Information Leaflet provided by your pharmacist before||
1265|071|H|you start taking hydrocodone/chlorpheniramine and each time you||
1265|072|H|get a refill. If you have any questions, ask your doctor or||
1265|073|H|pharmacist.||
1265|074|H|   Take this medication by mouth with or without food as directed||
1265|075|H|by your doctor, usually every 12 hours.||
1265|076|H|   Do not increase your dose or take this medication more often||
1265|077|H|than every 12 hours or for longer than prescribed. Doing so may||
1265|078|H|increase the risk of serious (possibly fatal) breathing problems.||
1265|079|H|   Shake this medication well before each dose. Carefully measure||
1265|080|H|the dose using a special measuring device/spoon. Do not use a||
1265|081|H|household spoon because you may not get the correct dose. Do not||
1265|082|H|mix this medication with other liquids or medications. Doing so||
1265|083|H|can release all of the drug at once, increasing the risk of side||
1265|084|H|effects.||
1265|085|H|   If you suddenly stop using this medication, you may have||
1265|086|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
1265|087|H|nose, nausea, sweating, muscle aches). To help prevent||
1265|088|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1265|089|H|more likely if you have used this medication for a long time or||
1265|090|H|in high doses. Tell your doctor or pharmacist right away if you||
1265|091|H|have withdrawal.||
1265|092|H|   When this medication is used for a long time, it may not work||
1265|093|H|as well. Talk with your doctor if this medication stops working||
1265|094|H|well.||
1265|095|H|   Though it helps many people, this medication may sometimes||
1265|096|H|cause addiction. This risk may be higher if you have a||
1265|097|H|mental/mood disorder or a substance use disorder (such as overuse||
1265|098|H|of or addiction to drugs/alcohol). Take this medication exactly||
1265|099|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1265|100|H|pharmacist for more details.||
1265|101|H|   Tell your doctor if your cough does not get better in 5 days||
1265|102|H|or if your condition lasts or gets worse.||
1265|103|B|||
1265|104|S|SIDE EFFECTS:  See also Warning section.||
1265|105|S|   Drowsiness, dizziness, nausea/vomiting, constipation, blurred||
1265|106|S|vision, dry mouth/nose/throat may occur. If any of these effects||
1265|107|S|last or get worse, notify your doctor or pharmacist promptly.||
1265|108|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
1265|109|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1265|110|S|substitute. This medication can dry up and thicken mucus in your||
1265|111|S|lungs, making it more difficult to breathe and clear your lungs.||
1265|112|S|To help prevent this effect, drink plenty of fluids unless||
1265|113|S|otherwise directed by your doctor.||
1265|114|S|   To prevent constipation, eat dietary fiber, drink enough||
1265|115|S|water, and exercise. You may also need to take a laxative. Ask||
1265|116|S|your pharmacist which type of laxative is right for you.||
1265|117|S|   To reduce the risk of dizziness and lightheadedness, get up||
1265|118|S|slowly when rising from a sitting or lying position.||
1265|119|S|   Remember that this medication has been prescribed because your||
1265|120|S|doctor has judged that the benefit to you is greater than the||
1265|121|S|risk of side effects. Many people using this medication do not||
1265|122|S|have serious side effects.||
1265|123|S|   Tell your doctor right away if you have any serious side||
1265|124|S|effects, including: interrupted breathing during sleep (sleep||
1265|125|S|apnea), mental/mood changes (such as depression, agitation,||
1265|126|S|confusion, hallucinations), stomach/abdominal pain, difficulty||
1265|127|S|urinating, fast/slow/irregular heartbeat, trouble swallowing.||
1265|128|S|   Get medical help right away if you have any very serious side||
1265|129|S|effects, including: slow/shallow breathing, fainting, severe||
1265|130|S|drowsiness/difficulty waking up, seizures.||
1265|131|S|   A very serious allergic reaction to this drug is rare.||
1265|132|S|However, get medical help right away if you notice any symptoms||
1265|133|S|of a serious allergic reaction, including: rash, itching/swelling||
1265|134|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1265|135|S|breathing.||
1265|136|S|   This is not a complete list of possible side effects. If you||
1265|137|S|notice other effects not listed above, contact your doctor or||
1265|138|S|pharmacist.||
1265|139|S|   In the US -||
1265|140|S|   Call your doctor for medical advice about side effects. You||
1265|141|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1265|142|S|www.fda.gov/medwatch.||
1265|143|S|   In Canada - Call your doctor for medical advice about side||
1265|144|S|effects. You may report side effects to Health Canada at||
1265|145|S|1-866-234-2345.||
1265|146|B|||
1265|147|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1265|148|P|pharmacist if you are allergic to hydrocodone or||
1265|149|P|chlorpheniramine; or to dexchlorpheniramine; or to other opioids||
1265|150|P|(such as benzhydrocodone, codeine, hydromorphone); or if you have||
1265|151|P|any other allergies. This product may contain inactive||
1265|152|P|ingredients (including sulfites such as sodium metabisulfite),||
1265|153|P|which can cause allergic reactions or other problems. Talk to||
1265|154|P|your pharmacist for more details.||
1265|155|P|   Before using this medication, tell your doctor or pharmacist||
1265|156|P|your medical history, especially of: breathing problems (such as||
1265|157|P|asthma, croup, sleep apnea, chronic obstructive pulmonary||
1265|158|P|disease-COPD), brain disorders (such as seizures, head injury,||
1265|159|P|tumor), stomach/intestinal problems (such as blockage,||
1265|160|P|constipation, diarrhea due to infection, paralytic ileus),||
1265|161|P|glaucoma (narrow-angle), difficulty urinating (such as due to||
1265|162|P|enlarged prostate or urethral stricture), personal or family||
1265|163|P|history of a substance use disorder (such as overuse of or||
1265|164|P|addiction to drugs/alcohol), kidney disease, liver disease,||
1265|165|P|gallbladder disease, underactive thyroid (hypothyroidism),||
1265|166|P|adrenal gland problem (such as Addison's disease), disease of the||
1265|167|P|pancreas (pancreatitis), mental/mood disorders (such as||
1265|168|P|confusion, depression, thoughts of suicide, toxic psychosis),||
1265|169|P|heart problems (such as irregular heartbeat).||
1265|170|P|   This drug may make you dizzy or drowsy or blur your vision.||
1265|171|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1265|172|P|drowsy. Do not drive, use machinery, or do anything that needs||
1265|173|P|alertness or clear vision until you can do it safely. Avoid||
1265|174|P|alcoholic beverages. Talk to your doctor if you are using||
1265|175|P|marijuana (cannabis).||
1265|176|P|   Before having surgery, tell your doctor or dentist about all||
1265|177|P|the products you use (including prescription drugs,||
1265|178|P|nonprescription drugs, and herbal products).||
1265|179|P|   This medication may contain sugar. If you have diabetes, ask||
1265|180|P|your doctor or pharmacist how to use this product safely.||
1265|181|P|   Older adults may be more sensitive to the side effects of this||
1265|182|P|drug, especially confusion, dizziness, drowsiness, constipation,||
1265|183|P|trouble urinating, and slow/shallow breathing. Drowsiness,||
1265|184|P|dizziness, and confusion can increase the risk of falling.||
1265|185|P|   Tell your doctor if you are pregnant or think you may be||
1265|186|P|pregnant. During pregnancy, this product is not recommended. It||
1265|187|P|may harm an unborn baby. Talk to your doctor about the risks and||
1265|188|P|benefits of this medication. See also Warning section.||
1265|189|P|   This product passes into breast milk and may have undesirable||
1265|190|P|effects on a nursing infant (such as unusual sleepiness,||
1265|191|P|difficulty feeding, trouble breathing, or unusual limpness).||
1265|192|P|Breastfeeding is not recommended while using this product.||
1265|193|P|Consult your doctor before breastfeeding.||
1265|194|B|||
1265|195|I|DRUG INTERACTIONS:  See also Warning section.||
1265|196|I|   Drug interactions may change how your medications work or||
1265|197|I|increase your risk for serious side effects. This document does||
1265|198|I|not contain all possible drug interactions. Keep a list of all||
1265|199|I|the products you use (including prescription/nonprescription||
1265|200|I|drugs and herbal products) and share it with your doctor and||
1265|201|I|pharmacist. Do not start, stop, or change the dosage of any||
1265|202|I|medicines without your doctor's approval.||
1265|203|I|   Some products that may interact with this drug include:||
1265|204|I|antihistamines applied to the skin (such as diphenhydramine||
1265|205|I|cream, ointment, spray), certain pain medications (mixed opioid||
1265|206|I|agonist-antagonists such as butorphanol, nalbuphine,||
1265|207|I|pentazocine), naltrexone, samidorphan.||
1265|208|I|   The risk of serious side effects (such as slow/shallow||
1265|209|I|breathing, severe drowsiness/dizziness) may be increased if this||
1265|210|I|medication is taken with other products that may also cause||
1265|211|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1265|212|I|if you are taking other products such as other opioid pain or||
1265|213|I|cough relievers (such as codeine, hydromorphone), alcohol,||
1265|214|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1265|215|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1265|216|I|carisoprodol, cyclobenzaprine), or other antihistamines (such as||
1265|217|I|cetirizine, diphenhydramine).||
1265|218|I|   Check the labels on all your medicines (such as allergy or||
1265|219|I|other cough-and-cold products) because they may contain||
1265|220|I|ingredients that cause drowsiness. Ask your pharmacist about||
1265|221|I|using those products safely.||
1265|222|I|   Other medications can affect the removal of||
1265|223|I|hydrocodone/chlorpheniramine from your body, which may affect how||
1265|224|I|hydrocodone/chlorpheniramine works. Examples include azole||
1265|225|I|antifungals (such as ketoconazole), macrolide antibiotics (such||
1265|226|I|as erythromycin), mifepristone, HIV medications (such as||
1265|227|I|tipranavir), rifamycins (such as rifabutin, rifampin), ritonavir,||
1265|228|I|certain drugs used to treat seizures (such as carbamazepine,||
1265|229|I|phenytoin), among others.||
1265|230|I|   Chlorpheniramine is very similar to dexchlorpheniramine. Do||
1265|231|I|not use medications containing dexchlorpheniramine while using||
1265|232|I|chlorpheniramine.||
1265|233|I|   This medication may interfere with certain lab tests (such as||
1265|234|I|allergy skin testing, amylase/lipase levels), possibly causing||
1265|235|I|false test results. Make sure lab personnel and all your doctors||
1265|236|I|know you use this drug.||
1265|237|B|||
1265|238|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1265|239|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1265|240|O|poison control center right away. US residents can call||
1265|241|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1265|242|O|Symptoms of overdose may include: slow/shallow breathing, severe||
1265|243|O|drowsiness/dizziness, mental/mood changes (such as confusion,||
1265|244|O|agitation), cold/clammy skin, fast/slow/irregular heartbeat,||
1265|245|O|seizures, coma.||
1265|246|B|||
1265|247|N|NOTES:  Do not share this medication with others. Sharing it is||
1265|248|N|against the law.||
1265|249|B|||
1265|250|D|MISSED DOSE:  If you are prescribed this medication on a regular||
1265|251|D|schedule and miss a dose, take it as soon as you remember. If it||
1265|252|D|is near the time of the next dose, skip the missed dose. Take||
1265|253|D|your next dose at the regular time. Do not double the dose to||
1265|254|D|catch up.||
1265|255|B|||
1265|256|R|STORAGE:  Store at room temperature away from light and moisture.||
1265|257|R|Do not store in the bathroom. Keep all medications away from||
1265|258|R|children and pets.||
1265|259|R|   Do not flush medications down the toilet or pour them into a||
1265|260|R|drain unless instructed to do so. Properly discard this product||
1265|261|R|when it is expired or no longer needed. Consult your pharmacist||
1265|262|R|or local waste disposal company.||
1265|263|B|||
1265|264|A|Information last revised August 2025.||
1265|265|A|Copyright(c) 2025 First Databank, Inc.||
1265|266|B|||
1266|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1266|002|Z|does NOT have all possible information about this product. This||
1266|003|Z|information does not assure that this product is safe, effective,||
1266|004|Z|or appropriate for you. This information is not individual||
1266|005|Z|medical advice and does not substitute for the advice of your||
1266|006|Z|health care professional. Always ask your health care||
1266|007|Z|professional for complete information about this product and your||
1266|008|Z|specific health needs.||
1266|009|B|||
1266|010|T|BRINZOLAMIDE/TIMOLOL SUSPENSION - OPHTHALMIC||
1266|011|F|(brin-ZOE-la-mide/TIM-oh-lol)||
1266|012|B|||
1266|013|U|USES:  This product contains two medications used to treat high||
1266|014|U|pressure inside the eye due to glaucoma (open angle-type) or||
1266|015|U|other eye diseases (such as ocular hypertension). Lowering high||
1266|016|U|pressure inside the eye helps to prevent blindness. These two||
1266|017|U|medications work together to decrease the amount of fluid within||
1266|018|U|the eye. Brinzolamide belongs to a class of drugs known as||
1266|019|U|carbonic anhydrase inhibitors. Timolol belongs to a class of||
1266|020|U|drugs known as beta-blockers.||
1266|021|B|||
1266|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1266|023|H|from your pharmacist before you start using brinzolamide/timolol||
1266|024|H|and each time you get a refill. If you have any questions, ask||
1266|025|H|your doctor or pharmacist.||
1266|026|H|   Use this medication in the affected eye(s) as directed by your||
1266|027|H|doctor, usually 2 times a day. Shake the bottle well before each||
1266|028|H|dose.||
1266|029|H|   To apply eye drops, wash your hands first. To avoid||
1266|030|H|contamination, do not touch the dropper tip or let it touch your||
1266|031|H|eye or any other surface.||
1266|032|H|   The preservative in this product may be absorbed by contact||
1266|033|H|lenses. If you wear contact lenses, remove them before using your||
1266|034|H|eye drops. Wait at least 15 minutes after using this medication||
1266|035|H|before putting your contact lenses back in.||
1266|036|H|   Tilt your head back, look upward, and pull down the lower||
1266|037|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1266|038|H|and place one drop into the pouch. Look downward and gently close||
1266|039|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
1266|040|H|your eye (near the nose) and apply gentle pressure. This will||
1266|041|H|prevent the medication from draining out. Try not to blink and do||
1266|042|H|not rub your eye. Repeat these steps for your other eye if so||
1266|043|H|directed.||
1266|044|H|   Do not rinse the dropper. Replace the dropper cap after each||
1266|045|H|use.||
1266|046|H|   If you are using another kind of eye medication (such as drops||
1266|047|H|or ointments), wait at least 5 minutes before applying other||
1266|048|H|medications. Use eye drops before eye ointments to allow the eye||
1266|049|H|drops to enter the eye.||
1266|050|H|   Wait several minutes for your vision to clear before driving||
1266|051|H|or operating machinery.||
1266|052|H|   Use this medication regularly in order to get the most benefit||
1266|053|H|from it. To help you remember, use it at the same times each day.||
1266|054|H|Keep using this medication even if you feel well. Most people||
1266|055|H|with glaucoma or high pressure in the eyes do not have symptoms.||
1266|056|B|||
1266|057|S|SIDE EFFECTS:  Temporary blurred vision, temporary||
1266|058|S|burning/stinging/itching/redness of the eye, dry eyes, feeling as||
1266|059|S|if something is in the eye, bitter/sour/unusual taste in your||
1266|060|S|mouth, or headache may occur. If any of these effects last or get||
1266|061|S|worse, notify your doctor or pharmacist promptly.||
1266|062|S|   Remember that this medication has been prescribed because your||
1266|063|S|doctor has judged that the benefit to you is greater than the||
1266|064|S|risk of side effects. Many people using this medication do not||
1266|065|S|have serious side effects.||
1266|066|S|   Tell your doctor right away if you have any serious side||
1266|067|S|effects, including: dizziness, new or worsening symptoms of heart||
1266|068|S|failure (such as shortness of breath, swelling ankles/feet,||
1266|069|S|unusual tiredness, unusual/sudden weight gain), slow/irregular||
1266|070|S|heartbeat, eye or eyelid swelling/pain/discharge, mental/mood||
1266|071|S|changes (such as depression), coldness/numbness/pain in the hands||
1266|072|S|or feet.||
1266|073|S|   Get medical help right away if you have any very serious side||
1266|074|S|effects, including: wheezing/difficulty breathing, chest/jaw/left||
1266|075|S|arm pain, fainting, weakness on one side of the body, trouble||
1266|076|S|speaking, confusion, sudden vision changes.||
1266|077|S|   A very serious allergic reaction to this drug is rare.||
1266|078|S|However, get medical help right away if you notice any symptoms||
1266|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1266|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1266|081|S|breathing.||
1266|082|S|   This is not a complete list of possible side effects. If you||
1266|083|S|notice other effects not listed above, contact your doctor or||
1266|084|S|pharmacist.||
1266|085|S|   In the US -||
1266|086|S|   Call your doctor for medical advice about side effects. You||
1266|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1266|088|S|www.fda.gov/medwatch.||
1266|089|S|   In Canada - Call your doctor for medical advice about side||
1266|090|S|effects. You may report side effects to Health Canada at||
1266|091|S|1-866-234-2345.||
1266|092|B|||
1266|093|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1266|094|P|pharmacist if you are allergic to timolol or other beta-blockers;||
1266|095|P|or to brinzolamide; or if you have any other allergies. This||
1266|096|P|product may contain inactive ingredients, which can cause||
1266|097|P|allergic reactions or other problems. Talk to your pharmacist for||
1266|098|P|more details.||
1266|099|P|   Before using this medication, tell your doctor or pharmacist||
1266|100|P|your medical history, especially of: lung disease/breathing||
1266|101|P|problems (such as current or past history of asthma, severe||
1266|102|P|chronic obstructive pulmonary disease), slow/irregular heartbeat||
1266|103|P|(such as sinus bradycardia, second- or third-degree AV block),||
1266|104|P|heart disease (such as chest pain, heart failure), kidney disease||
1266|105|P|(such as kidney stones, renal failure), liver disease, diabetes,||
1266|106|P|low blood flow to the brain (cerebrovascular insufficiency),||
1266|107|P|overactive thyroid disease, certain muscle/nerve disease||
1266|108|P|(myasthenia gravis), severe allergic reaction (such as||
1266|109|P|anaphylaxis, atopy).||
1266|110|P|   If you develop an eye infection or injury, or have eye||
1266|111|P|surgery, check with your doctor about whether you should continue||
1266|112|P|to use your current bottle of brinzolamide/timolol. You may be||
1266|113|P|advised to start using a new bottle.||
1266|114|P|   Before having surgery, tell your doctor or dentist about all||
1266|115|P|the products you use (including prescription drugs,||
1266|116|P|nonprescription drugs, and herbal products).||
1266|117|P|   After you apply this drug, your vision may become temporarily||
1266|118|P|blurred. Do not drive, use machinery, or do anything that needs||
1266|119|P|clear vision until you can do it safely.||
1266|120|P|   This product may prevent the fast/pounding heartbeat you would||
1266|121|P|usually feel when your blood sugar level falls too low||
1266|122|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
1266|123|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
1266|124|P|blood sugar level, such as dizziness and sweating, are not||
1266|125|P|affected by this drug.||
1266|126|P|   If you have diabetes, this product may make it harder to||
1266|127|P|control your blood sugar levels. Check your blood sugar levels||
1266|128|P|regularly as directed by your doctor. Tell your doctor right away||
1266|129|P|if you have symptoms of high blood sugar such as increased||
1266|130|P|thirst/urination. Your doctor may need to adjust your diabetes||
1266|131|P|medication, exercise program, or diet.||
1266|132|P|   During pregnancy, this medication should be used only when||
1266|133|P|clearly needed. Discuss the risks and benefits with your doctor.||
1266|134|P|   This medication passes into breast milk, but is unlikely to||
1266|135|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1266|136|B|||
1266|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1266|138|I|medications work or increase your risk for serious side effects.||
1266|139|I|This document does not contain all possible drug interactions.||
1266|140|I|Keep a list of all the products you use (including||
1266|141|I|prescription/nonprescription drugs and herbal products) and share||
1266|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
1266|143|I|the dosage of any medicines without your doctor's approval.||
1266|144|I|   Some products that may interact with this drug include:||
1266|145|I|beta-blockers (such as propranolol), clonidine, digoxin,||
1266|146|I|epinephrine, methyldopa.||
1266|147|I|   Other medications can affect the removal of||
1266|148|I|brinzolamide/timolol from your body, which may affect how this||
1266|149|I|medication works. Examples include cimetidine, ketoconazole,||
1266|150|I|itraconazole, clotrimazole, quinidine, ritonavir, troleandomycin,||
1266|151|I|certain antidepressants (such as SSRIs like fluoxetine), among||
1266|152|I|others.||
1266|153|B|||
1266|154|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1266|155|O|has overdosed and has serious symptoms such as passing out or||
1266|156|O|trouble breathing, call 911. Otherwise, call a poison control||
1266|157|O|center right away. US residents can call 1-800-222-1222. Canada||
1266|158|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1266|159|O|include: trouble breathing or slow/irregular heartbeat.||
1266|160|B|||
1266|161|N|NOTES:  Do not share this medication with others.||
1266|162|N|   Lab and/or medical tests (such as eye exams, heart rate)||
1266|163|N|should be done while you are using this medication. Keep all||
1266|164|N|medical and lab appointments. Consult your doctor for more||
1266|165|N|details.||
1266|166|B|||
1266|167|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1266|168|D|If it is near the time of the next dose, skip the missed dose.||
1266|169|D|Use your next dose at the regular time. Do not double the dose to||
1266|170|D|catch up.||
1266|171|B|||
1266|172|R|STORAGE:  Store at room temperature or in the refrigerator. Do||
1266|173|R|not freeze. Once the bottle is opened, this medication expires||
1266|174|R|after 60 days. Keep all medications away from children and pets.||
1266|175|R|   Do not flush medications down the toilet or pour them into a||
1266|176|R|drain unless instructed to do so. Properly discard this product||
1266|177|R|when it is expired or no longer needed. Consult your pharmacist||
1266|178|R|or local waste disposal company.||
1266|179|B|||
1266|180|A|Information last revised September 2024.||
1266|181|A|Copyright(c) 2025 First Databank, Inc.||
1266|182|B|||
1267|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1267|002|Z|does NOT have all possible information about this product. This||
1267|003|Z|information does not assure that this product is safe, effective,||
1267|004|Z|or appropriate for you. This information is not individual||
1267|005|Z|medical advice and does not substitute for the advice of your||
1267|006|Z|health care professional. Always ask your health care||
1267|007|Z|professional for complete information about this product and your||
1267|008|Z|specific health needs.||
1267|009|B|||
1267|010|T|TELAVANCIN - INJECTION||
1267|011|F|(TEL-a-VAN-sin)||
1267|012|B|||
1267|013|C|COMMON BRAND NAME(S): Vibativ||
1267|014|B|||
1267|015|W|WARNING:  Adults with moderate to severe kidney disease who are||
1267|016|W|using telavancin to treat serious lung infections may be at an||
1267|017|W|increased risk for death. Discuss the risks and benefits of this||
1267|018|W|medication, as well as other effective and possibly safer||
1267|019|W|treatments for lung infections, with your doctor.||
1267|020|W|   Telavancin may cause or worsen kidney problems. Problems are||
1267|021|W|more likely to occur if you have heart failure, kidney disease,||
1267|022|W|diabetes, or high blood pressure, or if you take certain||
1267|023|W|medications (see also Drug Interactions section). Kidney function||
1267|024|W|tests must be performed before you start treatment, during||
1267|025|W|treatment, and after you finish treatment to check for kidney||
1267|026|W|problems. Tell your doctor right away if you have any signs of||
1267|027|W|kidney problems such as a change in the amount of urine.||
1267|028|W|   Tell your doctor if you are pregnant or plan to become||
1267|029|W|pregnant. Your doctor may order a pregnancy test before starting||
1267|030|W|this medication. You should not become pregnant while using||
1267|031|W|telavancin. Telavancin may harm an unborn baby. Women of||
1267|032|W|childbearing age should ask about reliable forms of birth control||
1267|033|W|while using this medication and for 2 days after the last dose.||
1267|034|W|If you become pregnant, talk to your doctor right away about the||
1267|035|W|risks and benefits of this medication.||
1267|036|B|||
1267|037|U|USES:  This medication is an antibiotic used to treat serious||
1267|038|U|bacterial infections of the skin and certain types of pneumonia.||
1267|039|U|It works by stopping the growth of bacteria.||
1267|040|B|||
1267|041|H|HOW TO USE:  Read the Medication Guide provided by your||
1267|042|H|pharmacist before you start using telavancin and each time you||
1267|043|H|get a refill. If you have any questions, ask your doctor or||
1267|044|H|pharmacist.||
1267|045|H|   This medication is given by injection into a vein as directed||
1267|046|H|by your doctor, usually once a day. It should be injected slowly||
1267|047|H|over 60 minutes. The dosage and length of treatment is based on||
1267|048|H|your weight, medical condition, and response to treatment.||
1267|049|H|   If you are giving this medication to yourself at home, learn||
1267|050|H|all preparation and usage instructions from your health care||
1267|051|H|professional. Before using, check this product for particles or||
1267|052|H|discoloration. If either is present, do not use the liquid. Learn||
1267|053|H|how to store and discard medical supplies safely.||
1267|054|H|   Infusion reactions may happen during the infusion of this drug||
1267|055|H|if this drug is injected too fast. Tell your doctor right away if||
1267|056|H|you have any symptoms of infusion reactions such as flushing of||
1267|057|H|the upper body. Your doctor may slow down or stop your treatment||
1267|058|H|for some time.||
1267|059|H|   For the best effect, use this antibiotic at evenly spaced||
1267|060|H|times. To help you remember, use this medication at the same||
1267|061|H|time(s) every day.||
1267|062|H|   Continue to use this medication until the full prescribed||
1267|063|H|amount is finished, even if symptoms disappear after a few days.||
1267|064|H|Stopping the medication too early may result in a return of the||
1267|065|H|infection.||
1267|066|H|   Tell your doctor if your condition lasts or gets worse.||
1267|067|B|||
1267|068|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1267|069|S|   Metallic/soapy taste, nausea, vomiting, or foamy urine may||
1267|070|S|occur. If any of these effects last or get worse, tell your||
1267|071|S|doctor or pharmacist promptly.||
1267|072|S|   Remember that this medication has been prescribed because your||
1267|073|S|doctor has judged that the benefit to you is greater than the||
1267|074|S|risk of side effects. Many people using this medication do not||
1267|075|S|have serious side effects.||
1267|076|S|   Get medical help right away if you have any very serious side||
1267|077|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1267|078|S|fainting.||
1267|079|S|   This medication may rarely cause a severe intestinal condition||
1267|080|S|due to a bacteria called C. difficile. This condition may occur||
1267|081|S|during treatment or weeks to months after treatment has stopped.||
1267|082|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1267|083|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1267|084|S|stool.||
1267|085|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1267|086|S|products because they may make symptoms worse.||
1267|087|S|   Use of this medication for prolonged or repeated periods may||
1267|088|S|result in oral thrush or a new vaginal yeast infection. Contact||
1267|089|S|your doctor if you notice white patches in your mouth, a change||
1267|090|S|in vaginal discharge, or other new symptoms.||
1267|091|S|   A very serious allergic reaction to this drug is rare.||
1267|092|S|However, get medical help right away if you notice any symptoms||
1267|093|S|of a serious allergic reaction, including: rash, itching/swelling||
1267|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1267|095|S|breathing.||
1267|096|S|   This is not a complete list of possible side effects. If you||
1267|097|S|notice other effects not listed above, contact your doctor or||
1267|098|S|pharmacist.||
1267|099|S|   In the US -||
1267|100|S|   Call your doctor for medical advice about side effects. You||
1267|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1267|102|S|www.fda.gov/medwatch.||
1267|103|S|   In Canada - Call your doctor for medical advice about side||
1267|104|S|effects. You may report side effects to Health Canada at||
1267|105|S|1-866-234-2345.||
1267|106|B|||
1267|107|P|PRECAUTIONS:  See also Warning section.||
1267|108|P|   Before using telavancin, tell your doctor or pharmacist if you||
1267|109|P|are allergic to it; or if you have any other allergies. This||
1267|110|P|product may contain inactive ingredients, which can cause||
1267|111|P|allergic reactions or other problems. Talk to your pharmacist for||
1267|112|P|more details.||
1267|113|P|   Before using this medication, tell your doctor or pharmacist||
1267|114|P|your medical history.||
1267|115|P|   Telavancin may cause a condition that affects the heart rhythm||
1267|116|P|(QT prolongation). QT prolongation can rarely cause serious||
1267|117|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1267|118|P|as severe dizziness, fainting) that need medical attention right||
1267|119|P|away.||
1267|120|P|   The risk of QT prolongation may be increased if you have||
1267|121|P|certain medical conditions or are taking other drugs that may||
1267|122|P|cause QT prolongation. Before using telavancin, tell your doctor||
1267|123|P|or pharmacist of all the drugs you take and if you have any of||
1267|124|P|the following conditions: certain heart problems (heart failure,||
1267|125|P|slow heartbeat, QT prolongation in the EKG), family history of||
1267|126|P|certain heart problems (QT prolongation in the EKG, sudden||
1267|127|P|cardiac death).||
1267|128|P|   Low levels of potassium or magnesium in the blood may also||
1267|129|P|increase your risk of QT prolongation. This risk may increase if||
1267|130|P|you use certain drugs (such as diuretics/"water pills") or if you||
1267|131|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1267|132|P|Talk to your doctor about using telavancin safely.||
1267|133|P|   Before having surgery, tell your doctor or dentist about all||
1267|134|P|the products you use (including prescription drugs,||
1267|135|P|nonprescription drugs, and herbal products).||
1267|136|P|   Telavancin may cause live bacterial vaccines (such as typhoid||
1267|137|P|vaccine) to not work well. Tell your health care professional||
1267|138|P|that you are using telavancin before having any||
1267|139|P|immunizations/vaccinations.||
1267|140|P|   Older adults may be more sensitive to the side effects of this||
1267|141|P|drug, especially QT prolongation (see above).||
1267|142|P|   During pregnancy, this medication should be used only when||
1267|143|P|clearly needed. It may harm an unborn baby. Consult your doctor||
1267|144|P|for more details. (See also Warning section.)||
1267|145|P|   It is unknown if this medication passes into breast milk.||
1267|146|P|Consult your doctor before breastfeeding.||
1267|147|B|||
1267|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1267|149|I|medications work or increase your risk for serious side effects.||
1267|150|I|This document does not contain all possible drug interactions.||
1267|151|I|Keep a list of all the products you use (including||
1267|152|I|prescription/nonprescription drugs and herbal products) and share||
1267|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
1267|154|I|the dosage of any medicines without your doctor's approval.||
1267|155|I|   Some products that may interact with this drug include: other||
1267|156|I|drugs that may affect the kidneys (including NSAIDs such as||
1267|157|I|ibuprofen), "blood thinners" (such as heparin).||
1267|158|I|   This medication may interfere with certain lab tests (such as||
1267|159|I|coagulation tests such as PT/INR/APPT, urine protein tests),||
1267|160|I|possibly causing false test results. Make sure lab personnel and||
1267|161|I|all your doctors know you use this drug.||
1267|162|B|||
1267|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1267|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1267|165|O|poison control center right away. US residents can call||
1267|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1267|167|B|||
1267|168|N|NOTES:  See also Warning section.||
1267|169|N|   Lab and/or medical tests (such as kidney function) may be done||
1267|170|N|while you are using this medication. Keep all medical and lab||
1267|171|N|appointments. Consult your doctor for more details.||
1267|172|B|||
1267|173|D|MISSED DOSE:  It is important to get each dose of this medication||
1267|174|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1267|175|D|right away for a new dosing schedule. Do not double the dose to||
1267|176|D|catch up.||
1267|177|B|||
1267|178|R|STORAGE:  Consult the product instructions and your pharmacist||
1267|179|R|for storage details. Keep all medications away from children and||
1267|180|R|pets.||
1267|181|R|   Do not flush medications down the toilet or pour them into a||
1267|182|R|drain unless instructed to do so. Properly discard this product||
1267|183|R|when it is expired or no longer needed. Consult your pharmacist||
1267|184|R|or local waste disposal company.||
1267|185|B|||
1267|186|A|Information last revised November 2024.||
1267|187|A|Copyright(c) 2025 First Databank, Inc.||
1267|188|B|||
1268|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1268|002|Z|does NOT have all possible information about this product. This||
1268|003|Z|information does not assure that this product is safe, effective,||
1268|004|Z|or appropriate for you. This information is not individual||
1268|005|Z|medical advice and does not substitute for the advice of your||
1268|006|Z|health care professional. Always ask your health care||
1268|007|Z|professional for complete information about this product and your||
1268|008|Z|specific health needs.||
1268|009|B|||
1268|010|T|LAMIVUDINE/ZIDOVUDINE - ORAL||
1268|011|F|(la-MIV-ue-deen/zye-DOE-vue-deen)||
1268|012|B|||
1268|013|C|COMMON BRAND NAME(S): Combivir||
1268|014|B|||
1268|015|W|WARNING:  Zidovudine, one of the medications in this product, can||
1268|016|W|decrease bone marrow function, which may lead to low numbers of||
1268|017|W|red and white blood cells. A low number of red blood cells can||
1268|018|W|lead to anemia. A low number of white blood cells can decrease||
1268|019|W|your body's ability to fight serious, life-threatening||
1268|020|W|infections. These serious side effects occur more often in people||
1268|021|W|with advanced HIV disease (AIDS). Tell your doctor right away if||
1268|022|W|you develop any signs of anemia (such as unusual tiredness, fast||
1268|023|W|breathing, pale skin, fast heartbeat) or signs of infection (such||
1268|024|W|as sore throat that doesn't go away, fever, chills). Your doctor||
1268|025|W|will check your blood cell counts while you are taking this||
1268|026|W|medication to decrease the risk of these side effects.||
1268|027|W|   Zidovudine may also cause muscle problems. Tell your doctor||
1268|028|W|right away if you develop signs of muscle problems (such as||
1268|029|W|wasting or decrease in muscle size, weight loss, muscle||
1268|030|W|weakness/pain/tenderness).||
1268|031|W|   Rarely, lamivudine and zidovudine have caused severe||
1268|032|W|(sometimes fatal) liver problems and a certain metabolic problem||
1268|033|W|(lactic acidosis). Get medical help right away if you develop||
1268|034|W|symptoms of liver problems (such as nausea that doesn't stop,||
1268|035|W|vomiting, stomach/abdominal pain, pale stools, dark urine,||
1268|036|W|yellowing eyes/skin, unusual tiredness), or of lactic acidosis||
1268|037|W|(such as stomach discomfort, nausea, vomiting, fast/difficult||
1268|038|W|breathing, drowsiness, muscle pain, weakness, cold skin). These||
1268|039|W|serious side effects may occur more often in women and obese||
1268|040|W|patients.||
1268|041|W|   If you have hepatitis B infection and HIV, you may have a||
1268|042|W|serious worsening of hepatitis symptoms if you stop taking||
1268|043|W|lamivudine. Talk with your doctor before stopping this||
1268|044|W|medication. Your doctor will monitor liver tests for several||
1268|045|W|months after you stop lamivudine. Tell your doctor right away if||
1268|046|W|you develop symptoms of worsening liver problems.||
1268|047|B|||
1268|048|U|USES:  This product contains 2 drugs: lamivudine and zidovudine.||
1268|049|U|It is used with other HIV medications to help control HIV||
1268|050|U|infection. It helps to decrease the amount of HIV in your body so||
1268|051|U|your immune system can work better. This lowers your chance of||
1268|052|U|getting HIV complications (such as new infections, cancer) and||
1268|053|U|improves your quality of life. Both lamivudine and zidovudine||
1268|054|U|belong to a class of drugs known as nucleoside reverse||
1268|055|U|transcriptase inhibitors (NRTIs).||
1268|056|U|   Lamivudine/zidovudine is not a cure for HIV infection. To||
1268|057|U|decrease your risk of spreading HIV disease to others, continue||
1268|058|U|to take all HIV medications exactly as prescribed by your doctor.||
1268|059|U|Use an effective barrier method (latex or polyurethane||
1268|060|U|condoms/dental dams) during sexual activity as directed by your||
1268|061|U|doctor. Do not share personal items (such as needles/syringes,||
1268|062|U|toothbrushes, and razors) that may have contacted blood or other||
1268|063|U|body fluids. Consult your doctor or pharmacist for more details.||
1268|064|B|||
1268|065|V|OTHER USES:  This section contains uses of this drug that are not||
1268|066|V|listed in the approved professional labeling for the drug but||
1268|067|V|that may be prescribed by your health care professional. Use this||
1268|068|V|drug for a condition that is listed in this section only if it||
1268|069|V|has been so prescribed by your health care professional.||
1268|070|V|   This product may also be used to lessen the risk of HIV||
1268|071|V|infection after contact with the virus (for example, due to a||
1268|072|V|needle stick). Ask your doctor for more details.||
1268|073|B|||
1268|074|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1268|075|H|from your pharmacist before you start taking||
1268|076|H|lamivudine/zidovudine, and each time you get a refill. If you||
1268|077|H|have any questions, consult your doctor or pharmacist.||
1268|078|H|   Take this medication by mouth with or without food as directed||
1268|079|H|by your doctor, usually 2 times daily. Take this medication with||
1268|080|H|a full glass of water (8 ounces/240 milliliters) unless your||
1268|081|H|doctor directs you otherwise.||
1268|082|H|   Because this combination product has fixed doses of lamivudine||
1268|083|H|and zidovudine, it should only be used if your doctor has||
1268|084|H|determined that the doses of both medications in this product are||
1268|085|H|right for you. This product is not to be used by children||
1268|086|H|weighing less than 30 kilograms (66 pounds).||
1268|087|H|   It is very important to keep taking this medication (and other||
1268|088|H|HIV medications) exactly as prescribed by your doctor. Do not||
1268|089|H|skip any doses. Do not increase your dose, take this drug more||
1268|090|H|often than prescribed, or stop taking it (or other HIV medicines)||
1268|091|H|even for a short time unless directed to do so by your doctor.||
1268|092|H|Skipping or changing your dose without approval from your doctor||
1268|093|H|may cause the amount of virus to increase, make the infection||
1268|094|H|more difficult to treat (resistant), or worsen side effects.||
1268|095|H|   For the best effect, take this medication at evenly spaced||
1268|096|H|times. To help you remember, take this medication at the same||
1268|097|H|times every day.||
1268|098|B|||
1268|099|S|SIDE EFFECTS:  See also Warning section.||
1268|100|S|   Headache, tiredness, loss of appetite, nausea, vomiting,||
1268|101|S|diarrhea, trouble sleeping, dizziness, or stuffy nose may occur.||
1268|102|S|If any of these effects last or get worse, tell your doctor or||
1268|103|S|pharmacist promptly.||
1268|104|S|   Remember that this medication has been prescribed because your||
1268|105|S|doctor has judged that the benefit to you is greater than the||
1268|106|S|risk of side effects. Many people using this medication do not||
1268|107|S|have serious side effects.||
1268|108|S|   As your immune system gets stronger, it can begin to fight off||
1268|109|S|infections you already had, possibly causing disease symptoms to||
1268|110|S|come back. You could also have symptoms if your immune system||
1268|111|S|becomes overactive. This reaction may happen at any time (soon||
1268|112|S|after starting HIV treatment or many months later). Tell your||
1268|113|S|doctor right away if you have any serious symptoms, including:||
1268|114|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1268|115|S|that doesn't go away, headaches that are severe or don't go away,||
1268|116|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1268|117|S|changes, signs of infection (such as sore throat that doesn't go||
1268|118|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1268|119|S|sores), signs of an overactive thyroid (such as irritability,||
1268|120|S|nervousness, heat intolerance, fast/pounding/irregular||
1268|121|S|heartbeat).||
1268|122|S|   Tell your doctor right away if you have any serious side||
1268|123|S|effects, including: mental/mood changes (such as depression),||
1268|124|S|signs of pancreatitis (such as nausea, vomiting,||
1268|125|S|stomach/abdominal/back pain, fever), easy bruising/bleeding,||
1268|126|S|skin/nail color changes.||
1268|127|S|   Loss of body fat (such as in the face, arms, legs, and||
1268|128|S|buttocks) may occur while you are taking this medication. This||
1268|129|S|effect may be permanent. Tell your doctor right away if you||
1268|130|S|notice any changes in body fat.||
1268|131|S|   This medication can commonly cause a rash that is usually not||
1268|132|S|serious. However, you may not be able to tell it apart from a||
1268|133|S|rare rash that could be a sign of a severe reaction. Get medical||
1268|134|S|help right away if you develop any rash.||
1268|135|S|   A very serious allergic reaction to this drug is rare.||
1268|136|S|However, get medical help right away if you notice any symptoms||
1268|137|S|of a serious allergic reaction, including: rash, itching/swelling||
1268|138|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1268|139|S|breathing.||
1268|140|S|   This is not a complete list of possible side effects. If you||
1268|141|S|notice other effects not listed above, contact your doctor or||
1268|142|S|pharmacist.||
1268|143|S|   In the US -||
1268|144|S|   Call your doctor for medical advice about side effects. You||
1268|145|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1268|146|S|www.fda.gov/medwatch.||
1268|147|S|   In Canada - Call your doctor for medical advice about side||
1268|148|S|effects. You may report side effects to Health Canada at||
1268|149|S|1-866-234-2345.||
1268|150|B|||
1268|151|P|PRECAUTIONS:  Before taking lamivudine/zidovudine, tell your||
1268|152|P|doctor or pharmacist if you are allergic to either drug; or if||
1268|153|P|you have any other allergies. This product may contain inactive||
1268|154|P|ingredients, which can cause allergic reactions or other||
1268|155|P|problems. Talk to your pharmacist for more details.||
1268|156|P|   Before using this medication, tell your doctor or pharmacist||
1268|157|P|your medical history, especially of: kidney problems, liver||
1268|158|P|problems (such as hepatitis B or C, cirrhosis), disease of the||
1268|159|P|pancreas (pancreatitis), alcohol use, low red/white blood cell||
1268|160|P|counts.||
1268|161|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1268|162|P|can make you more dizzy. Do not drive, use machinery, or do||
1268|163|P|anything that needs alertness until you can do it safely. Limit||
1268|164|P|alcoholic beverages. Talk to your doctor if you are using||
1268|165|P|marijuana (cannabis).||
1268|166|P|   Also limit alcohol because it can increase the risk of liver||
1268|167|P|problems and pancreatitis.||
1268|168|P|   Children may be more sensitive to the side effects of this||
1268|169|P|drug, especially pancreatitis.||
1268|170|P|   Before having surgery, tell your doctor or dentist about all||
1268|171|P|the products you use (including prescription drugs,||
1268|172|P|nonprescription drugs, and herbal products).||
1268|173|P|   Tell your doctor if you are pregnant before using this||
1268|174|P|medication. Treatment can lower the risk of passing HIV infection||
1268|175|P|to your baby. Discuss the risks and benefits with your doctor.||
1268|176|P|   This medication passes into breast milk. Because breast milk||
1268|177|P|may transmit HIV, consult your doctor before breastfeeding.||
1268|178|B|||
1268|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1268|180|I|medications work or increase your risk for serious side effects.||
1268|181|I|This document does not contain all possible drug interactions.||
1268|182|I|Keep a list of all the products you use (including||
1268|183|I|prescription/nonprescription drugs and herbal products) and share||
1268|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
1268|185|I|the dosage of any medicines without your doctor's approval.||
1268|186|I|   Some products that may interact with this drug include:||
1268|187|I|orlistat, ribavirin, sorbitol, stavudine, drugs that may decrease||
1268|188|I|bone marrow function or lower blood cell counts (such as||
1268|189|I|ganciclovir, trimethoprim, cancer chemotherapy including||
1268|190|I|doxorubicin).||
1268|191|I|   Other medications can affect the removal of zidovudine from||
1268|192|I|your body, which may affect how lamivudine/zidovudine works.||
1268|193|I|Examples include rifampin, valproic acid, among others.||
1268|194|I|   If you are also taking clarithromycin, take this medication at||
1268|195|I|least 2 hours apart from your clarithromycin dose.||
1268|196|I|   Do not take other products that contain either lamivudine or||
1268|197|I|zidovudine with this medication.||
1268|198|I|   Emtricitabine is similar to lamivudine and should not be taken||
1268|199|I|with this medication.||
1268|200|B|||
1268|201|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1268|202|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1268|203|O|poison control center right away. US residents can call||
1268|204|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1268|205|B|||
1268|206|N|NOTES:  Do not share this medication with others.||
1268|207|N|   Lab and/or medical tests (such as blood cell counts,||
1268|208|N|liver/kidney function, viral load, T-cell counts) should be done||
1268|209|N|while you are taking this medication. Keep all medical and lab||
1268|210|N|appointments. Consult your doctor for more details.||
1268|211|B|||
1268|212|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1268|213|D|remember. If it is near the time of the next dose, skip the||
1268|214|D|missed dose. Take your next dose at the regular time. Do not||
1268|215|D|double the dose to catch up.||
1268|216|B|||
1268|217|R|STORAGE:  Store in the refrigerator or at room temperature away||
1268|218|R|from light and moisture. Do not store in the bathroom. Keep all||
1268|219|R|medications away from children and pets.||
1268|220|R|   Do not flush medications down the toilet or pour them into a||
1268|221|R|drain unless instructed to do so. Properly discard this product||
1268|222|R|when it is expired or no longer needed. Consult your pharmacist||
1268|223|R|or local waste disposal company.||
1268|224|B|||
1268|225|A|Information last revised August 2025.||
1268|226|A|Copyright(c) 2025 First Databank, Inc.||
1268|227|B|||
1269|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1269|002|Z|does NOT have all possible information about this product. This||
1269|003|Z|information does not assure that this product is safe, effective,||
1269|004|Z|or appropriate for you. This information is not individual||
1269|005|Z|medical advice and does not substitute for the advice of your||
1269|006|Z|health care professional. Always ask your health care||
1269|007|Z|professional for complete information about this product and your||
1269|008|Z|specific health needs.||
1269|009|B|||
1269|010|T|HUMAN PAPILLOMAVIRUS VACCINE (TYPES 16,18) - INJECTION||
1269|011|B|||
1269|012|C|COMMON BRAND NAME(S): Cervarix||
1269|013|B|||
1269|014|U|USES:  This vaccine is used to help prevent cancer of the cervix.||
1269|015|U|It is also used to prevent abnormal tissue growth in the cervix||
1269|016|U|that can lead to cancer. These conditions are commonly caused by||
1269|017|U|certain types of human papillomavirus (HPV). This vaccine works||
1269|018|U|by increasing the body's natural defense (immunity) against the||
1269|019|U|virus. This vaccine does not protect against all types of HPV,||
1269|020|U|only the types in the vaccine.||
1269|021|U|   Vaccines may not fully protect everyone who receives them.||
1269|022|B|||
1269|023|H|HOW TO USE:  Read all vaccine information available from your||
1269|024|H|health care professional before receiving the vaccine. If you||
1269|025|H|have any questions, ask your health care professional.||
1269|026|H|   This vaccine is given by injection into the muscle of the||
1269|027|H|upper arm by a health care professional.||
1269|028|H|   Vaccines are usually given in a series of doses to provide the||
1269|029|H|best protection. Closely follow the vaccination schedule provided||
1269|030|H|by your health care professional. To help you remember, mark your||
1269|031|H|calendar with a reminder.||
1269|032|H|   This vaccine may be given at the same time as other vaccines.||
1269|033|B|||
1269|034|S|SIDE EFFECTS:  Redness, swelling, and pain at the injection site||
1269|035|S|may occur. If any of these effects last or get worse, tell your||
1269|036|S|health care professional promptly.||
1269|037|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1269|038|S|vision changes, or ringing in the ears just after getting a||
1269|039|S|vaccine injection. Seizure-like movements may also rarely happen||
1269|040|S|after injection with this vaccine. Tell your health care||
1269|041|S|professional right away if you have any of these symptoms.||
1269|042|S|Sitting or lying down may help, since these symptoms usually||
1269|043|S|don't last long.||
1269|044|S|   Remember that this vaccine has been prescribed because your||
1269|045|S|health care professional has judged that the benefit to you is||
1269|046|S|greater than the risk of side effects. Many people using this||
1269|047|S|vaccine do not have serious side effects.||
1269|048|S|   A very serious allergic reaction to this vaccine is rare.||
1269|049|S|However, get medical help right away if you notice any symptoms||
1269|050|S|of a serious allergic reaction, including: rash, itching/swelling||
1269|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1269|052|S|breathing.||
1269|053|S|   This is not a complete list of possible side effects. If you||
1269|054|S|notice other effects not listed above, contact your health care||
1269|055|S|professional.||
1269|056|S|   Contact the health care professional for medical advice about||
1269|057|S|side effects. The following numbers do not provide medical||
1269|058|S|advice, but in the US you may report side effects to the Vaccine||
1269|059|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1269|060|S|Canada, you may call the Vaccine Safety Section at Public Health||
1269|061|S|Agency of Canada at 1-866-844-0018.||
1269|062|B|||
1269|063|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
1269|064|P|care professional if you are allergic to it; or if you have any||
1269|065|P|other allergies. This product may contain inactive ingredients||
1269|066|P|(such as latex found in the packaging of some products), which||
1269|067|P|can cause allergic reactions or other problems. Talk to your||
1269|068|P|health care professional for more details.||
1269|069|P|   Before receiving this vaccine, tell your health care||
1269|070|P|professional your medical history, especially of: current||
1269|071|P|fever/illness, immune system disorders (such as due to HIV||
1269|072|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
1269|073|P|radiation treatment), vaccination history (including previous||
1269|074|P|reactions to any vaccines).||
1269|075|P|   This vaccine is not recommended for use during pregnancy.||
1269|076|P|Consult your health care professional for more details.||
1269|077|P|   It is unknown if this vaccine passes into breast milk. Consult||
1269|078|P|your health care professional before breastfeeding.||
1269|079|B|||
1269|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1269|081|I|medications work or increase your risk for serious side effects.||
1269|082|I|This document does not contain all possible drug interactions.||
1269|083|I|Keep a list of all the products you use (including||
1269|084|I|prescription/nonprescription drugs and herbal products) and share||
1269|085|I|it with your health care professional. Do not start, stop, or||
1269|086|I|change the dosage of any medicines without your doctor's||
1269|087|I|approval.||
1269|088|I|   Some products that may interact with this vaccine are: drugs||
1269|089|I|that weaken the immune system (including cyclosporine,||
1269|090|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1269|091|I|prednisone).||
1269|092|B|||
1269|093|O|OVERDOSE:  Not applicable.||
1269|094|B|||
1269|095|N|NOTES:  Keep all medical and lab appointments. Getting this||
1269|096|N|vaccine does not replace cervical cancer screening. Continue to||
1269|097|N|have regular obstetrician/gynecologist checkups.||
1269|098|N|   Keep vaccine records for yourself and your children and||
1269|099|N|provide them to the health care professionals to prevent||
1269|100|N|unnecessary re-vaccinations.||
1269|101|B|||
1269|102|D|MISSED DOSE:  It is important that you get each vaccination as||
1269|103|D|scheduled. Ask when you should get each dose and mark your||
1269|104|D|calendar with a reminder. If you miss a dose, call the health||
1269|105|D|care professional to reschedule.||
1269|106|B|||
1269|107|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
1269|108|R|light. Keep all medications away from children and pets.||
1269|109|R|   Do not flush medications down the toilet or pour them into a||
1269|110|R|drain unless instructed to do so. Properly discard this product||
1269|111|R|when it is expired or no longer needed. Consult your pharmacist||
1269|112|R|or local waste disposal company.||
1269|113|B|||
1269|114|A|Information last revised February 2025.||
1269|115|A|Copyright(c) 2025 First Databank, Inc.||
1269|116|B|||
1270|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1270|002|Z|does NOT have all possible information about this product. This||
1270|003|Z|information does not assure that this product is safe, effective,||
1270|004|Z|or appropriate for you. This information is not individual||
1270|005|Z|medical advice and does not substitute for the advice of your||
1270|006|Z|health care professional. Always ask your health care||
1270|007|Z|professional for complete information about this product and your||
1270|008|Z|specific health needs.||
1270|009|B|||
1270|010|T|TELMISARTAN/AMLODIPINE - ORAL||
1270|011|F|(TEL-mi-SAR-tan/am-LOE-di-peen)||
1270|012|B|||
1270|013|C|COMMON BRAND NAME(S): Twynsta||
1270|014|B|||
1270|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
1270|016|W|unborn baby if used during pregnancy. It is important to prevent||
1270|017|W|pregnancy while taking this medication. Consult your doctor for||
1270|018|W|more details and to discuss the use of reliable forms of birth||
1270|019|W|control while taking this medication. If you are planning||
1270|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
1270|021|W|your doctor right away.||
1270|022|B|||
1270|023|U|USES:  This product is used to treat high blood pressure||
1270|024|U|(hypertension). Lowering high blood pressure helps prevent||
1270|025|U|strokes, heart attacks, and kidney problems. This product||
1270|026|U|contains 2 medications: telmisartan and amlodipine. Telmisartan||
1270|027|U|is an angiotensin receptor blocker (ARB) and amlodipine is a||
1270|028|U|calcium channel blocker. They both work differently to relax the||
1270|029|U|blood vessels so that blood can flow more easily.||
1270|030|U|   These medications are used together when one drug is not||
1270|031|U|controlling your blood pressure. Your doctor may direct you to||
1270|032|U|start taking the individual medications first, and then switch||
1270|033|U|you to this combination product if it is the best dose||
1270|034|U|combination for you.||
1270|035|B|||
1270|036|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1270|037|H|from your pharmacist before you start taking||
1270|038|H|telmisartan/amlodipine and each time you get a refill. If you||
1270|039|H|have any questions, ask your doctor or pharmacist.||
1270|040|H|   Take this medication by mouth with or without food as directed||
1270|041|H|by your doctor, usually once daily.||
1270|042|H|   The dosage is based on your medical condition and response to||
1270|043|H|treatment.||
1270|044|H|   Use this medication regularly to get the most benefit from it.||
1270|045|H|To help you remember, take it at the same time each day. Keep||
1270|046|H|taking this medication even if you feel well. Most people with||
1270|047|H|high blood pressure do not feel sick. It may take up to 4 weeks||
1270|048|H|before you get the full benefit of this drug.||
1270|049|H|   Tell your doctor if your condition does not get better or if||
1270|050|H|it gets worse (your blood pressure readings remain high or||
1270|051|H|increase).||
1270|052|B|||
1270|053|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
1270|054|S|body adjusts to the medication. Swelling hands/ankles/feet or||
1270|055|S|flushing may also occur. If any of these effects last or get||
1270|056|S|worse, tell your doctor or pharmacist promptly.||
1270|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
1270|058|S|slowly when rising from a sitting or lying position.||
1270|059|S|   Remember that this medication has been prescribed because your||
1270|060|S|doctor has judged that the benefit to you is greater than the||
1270|061|S|risk of side effects. Many people using this medication do not||
1270|062|S|have serious side effects.||
1270|063|S|   Tell your doctor right away if you have any serious side||
1270|064|S|effects, including: fainting, fast/pounding/irregular heartbeat,||
1270|065|S|signs of kidney problems (such as change in the amount of urine),||
1270|066|S|symptoms of a high potassium blood level (such as muscle||
1270|067|S|weakness, slow/irregular heartbeat).||
1270|068|S|   Some people who already have severe heart disease may rarely||
1270|069|S|develop worsening chest pain or a heart attack after starting||
1270|070|S|this medication or increasing the dose. Get medical help right||
1270|071|S|away if you experience: worsening chest pain, symptoms of a heart||
1270|072|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
1270|073|S|unusual sweating).||
1270|074|S|   A very serious allergic reaction to this drug is rare.||
1270|075|S|However, get medical help right away if you notice any symptoms||
1270|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1270|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1270|078|S|breathing.||
1270|079|S|   This is not a complete list of possible side effects. If you||
1270|080|S|notice other effects not listed above, contact your doctor or||
1270|081|S|pharmacist.||
1270|082|S|   In the US -||
1270|083|S|   Call your doctor for medical advice about side effects. You||
1270|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1270|085|S|www.fda.gov/medwatch.||
1270|086|S|   In Canada - Call your doctor for medical advice about side||
1270|087|S|effects. You may report side effects to Health Canada at||
1270|088|S|1-866-234-2345.||
1270|089|B|||
1270|090|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1270|091|P|pharmacist if you are allergic to either telmisartan or||
1270|092|P|amlodipine; or to other calcium channel blockers (such as||
1270|093|P|nifedipine); or if you have any other allergies. This product may||
1270|094|P|contain inactive ingredients, which can cause allergic reactions||
1270|095|P|or other problems. Talk to your pharmacist for more details.||
1270|096|P|   Before using this medication, tell your doctor or pharmacist||
1270|097|P|your medical history, especially of: liver disease, high level of||
1270|098|P|potassium in the blood, dehydration, heart disease (such as||
1270|099|P|aortic stenosis, heart failure), bile duct blockage.||
1270|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1270|101|P|can make you more dizzy. Do not drive, use machinery, or do||
1270|102|P|anything that needs alertness until you can do it safely. Limit||
1270|103|P|alcoholic beverages. Talk to your doctor if you are using||
1270|104|P|marijuana (cannabis).||
1270|105|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1270|106|P|and cause you to feel lightheaded. Tell your doctor if you have||
1270|107|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1270|108|P|of fluids unless your doctor tells you not to.||
1270|109|P|   Before having surgery, tell your doctor or dentist about all||
1270|110|P|the products you use (including prescription drugs,||
1270|111|P|nonprescription drugs, and herbal products).||
1270|112|P|   This product may increase your potassium levels. Before using||
1270|113|P|potassium supplements or salt substitutes that contain potassium,||
1270|114|P|consult your doctor or pharmacist.||
1270|115|P|   Older adults may be more sensitive to the side effects of this||
1270|116|P|drug, especially dizziness and change in the amount of urine||
1270|117|P|(kidney problems).||
1270|118|P|   Tell your doctor if you are pregnant or plan to become||
1270|119|P|pregnant. You should not become pregnant while using||
1270|120|P|telmisartan/amlodipine. Telmisartan may harm an unborn baby. If||
1270|121|P|you become pregnant, talk to your doctor right away about the||
1270|122|P|risks and benefits of this medication. (See also Warning||
1270|123|P|section.)||
1270|124|P|   It is unknown if telmisartan passes into breast milk.||
1270|125|P|Amlodipine passes into breast milk. Consult your doctor before||
1270|126|P|breastfeeding.||
1270|127|B|||
1270|128|I|DRUG INTERACTIONS:  See also Precautions section.||
1270|129|I|   Drug interactions may change how your medications work or||
1270|130|I|increase your risk for serious side effects. This document does||
1270|131|I|not contain all possible drug interactions. Keep a list of all||
1270|132|I|the products you use (including prescription/nonprescription||
1270|133|I|drugs and herbal products) and share it with your doctor and||
1270|134|I|pharmacist. Do not start, stop, or change the dosage of any||
1270|135|I|medicines without your doctor's approval.||
1270|136|I|   Some products that may interact with this drug include:||
1270|137|I|aliskiren, lithium, drugs that may increase the level of||
1270|138|I|potassium in the blood (such as sparsentan, ACE inhibitors||
1270|139|I|including benazepril/lisinopril, birth control pills containing||
1270|140|I|drospirenone).||
1270|141|I|   Some products have ingredients that could raise your blood||
1270|142|I|pressure. Tell your pharmacist what products you are using, and||
1270|143|I|ask how to use them safely (especially cough-and-cold products,||
1270|144|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1270|145|B|||
1270|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1270|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1270|148|O|poison control center right away. US residents can call||
1270|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1270|150|O|Symptoms of overdose may include: severe dizziness, fainting,||
1270|151|O|fast heartbeat.||
1270|152|B|||
1270|153|N|NOTES:  Do not share this medication with others.||
1270|154|N|   Lab and/or medical tests (such as potassium levels, kidney||
1270|155|N|function) should be done while you are taking this medication.||
1270|156|N|Keep all medical and lab appointments. Consult your doctor for||
1270|157|N|more details.||
1270|158|N|   Lifestyle changes that may help this medication work better||
1270|159|N|include stress reduction programs, exercise, and dietary changes.||
1270|160|N|Talk to your doctor or pharmacist about lifestyle changes that||
1270|161|N|might benefit you.||
1270|162|N|   Have your blood pressure checked regularly while taking this||
1270|163|N|medication. Learn how to monitor your own blood pressure at home,||
1270|164|N|and share the results with your doctor.||
1270|165|B|||
1270|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1270|167|D|remember. If it is near the time of the next dose, skip the||
1270|168|D|missed dose. Take your next dose at the regular time. Do not||
1270|169|D|double the dose to catch up.||
1270|170|B|||
1270|171|R|STORAGE:  Store at room temperature away from light and moisture.||
1270|172|R|Do not remove the medication from the blister pack until right||
1270|173|R|before using. Do not store in the bathroom. Keep all medications||
1270|174|R|away from children and pets.||
1270|175|R|   Do not flush medications down the toilet or pour them into a||
1270|176|R|drain unless instructed to do so. Properly discard this product||
1270|177|R|when it is expired or no longer needed. Consult your pharmacist||
1270|178|R|or local waste disposal company.||
1270|179|B|||
1270|180|A|Information last revised May 2024.||
1270|181|A|Copyright(c) 2025 First Databank, Inc.||
1270|182|B|||
1272|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1272|002|Z|does NOT have all possible information about this product. This||
1272|003|Z|information does not assure that this product is safe, effective,||
1272|004|Z|or appropriate for you. This information is not individual||
1272|005|Z|medical advice and does not substitute for the advice of your||
1272|006|Z|health care professional. Always ask your health care||
1272|007|Z|professional for complete information about this product and your||
1272|008|Z|specific health needs.||
1272|009|B|||
1272|010|T|OFATUMUMAB - INJECTION||
1272|011|F|(oh-fuh-TOO-muh-mab)||
1272|012|B|||
1272|013|C|COMMON BRAND NAME(S): Arzerra||
1272|014|B|||
1272|015|W|WARNING:  This drug may cause serious (possibly fatal) liver||
1272|016|W|disease. Also, if you have a current or past infection with||
1272|017|W|hepatitis B, this drug may cause the infection to return or||
1272|018|W|worsen. This may occur during treatment or after treatment is||
1272|019|W|finished. Before starting treatment with this medication, your||
1272|020|W|doctor may order a test to see if you have hepatitis B infection.||
1272|021|W|Your doctor may also order blood tests and watch for symptoms of||
1272|022|W|liver disease during treatment and for months after your last||
1272|023|W|dose of this medication. Get medical help right away if you have||
1272|024|W|any symptoms of liver damage, including: nausea/vomiting that||
1272|025|W|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
1272|026|W|eyes/skin, dark urine.||
1272|027|W|   Ofatumumab increases your risk of getting a rare but very||
1272|028|W|serious (sometimes fatal) brain infection (progressive multifocal||
1272|029|W|leukoencephalopathy-PML). Get medical help right away if you||
1272|030|W|develop any signs of PML, including: loss of balance/dizziness,||
1272|031|W|confusion, difficulty walking/talking, seizure, vision changes.||
1272|032|B|||
1272|033|U|USES:  Ofatumumab is used to treat a certain type of cancer||
1272|034|U|(chronic lymphocytic leukemia - CLL). Ofatumumab belongs to a||
1272|035|U|class of drugs known as monoclonal antibodies. This medication||
1272|036|U|works by stopping the growth of cancer cells.||
1272|037|B|||
1272|038|H|HOW TO USE:  This medication is given by slow injection into a||
1272|039|H|vein by a health care professional. The dosage and treatment||
1272|040|H|schedule is based on your medical condition and response to||
1272|041|H|treatment.||
1272|042|H|   Serious (rarely fatal) infusion reactions may happen during||
1272|043|H|the infusion of this drug and for up to 24 hours afterward. These||
1272|044|H|reactions occur more often during the first and second||
1272|045|H|treatments. Your doctor may prescribe other medications||
1272|046|H|(including acetaminophen, an antihistamine such as||
1272|047|H|diphenhydramine, a corticosteroid such as methylprednisolone)||
1272|048|H|before each treatment to help prevent these side effects. Tell||
1272|049|H|your doctor right away if you have any symptoms of infusion||
1272|050|H|reactions such as chest pain, flushing, wheezing, trouble||
1272|051|H|breathing, dizziness, fainting, pounding/irregular heartbeat,||
1272|052|H|fever, chills, back/stomach pain, or rash/itching. Your doctor||
1272|053|H|may stop your treatment for some time.||
1272|054|B|||
1272|055|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1272|056|S|   Nausea, vomiting, diarrhea, tiredness, swelling of||
1272|057|S|hands/ankles/feet, or trouble sleeping may occur. If any of these||
1272|058|S|effects last or get worse, tell your doctor or pharmacist||
1272|059|S|promptly.||
1272|060|S|   People using this medication may have serious side effects.||
1272|061|S|However, you have been prescribed this drug because your doctor||
1272|062|S|has judged that the benefit to you is greater than the risk of||
1272|063|S|side effects. Careful monitoring by your doctor may decrease your||
1272|064|S|risk.||
1272|065|S|   This medication decreases bone marrow function, an effect that||
1272|066|S|may lead to a low number of blood cells such as red cells, white||
1272|067|S|cells, and platelets. This effect can cause anemia, decrease your||
1272|068|S|body's ability to fight an infection, or cause easy||
1272|069|S|bruising/bleeding. Your doctor will order blood tests to check||
1272|070|S|for this side effect. It is important to keep all medical/lab||
1272|071|S|test appointments. Tell your doctor right away if you develop any||
1272|072|S|of the following symptoms: easy bruising/bleeding, pale skin,||
1272|073|S|unusual tiredness, signs of infection (such as sore throat that||
1272|074|S|doesn't go away, fever, chills).||
1272|075|S|   Ofatumumab sometimes causes side effects due to the rapid||
1272|076|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1272|077|S|risk, your doctor may add a medication and tell you to drink||
1272|078|S|plenty of fluids. Tell your doctor right away if you have||
1272|079|S|symptoms such as: low back/side pain (flank pain), signs of||
1272|080|S|kidney problems (such as painful urination, pink/bloody urine,||
1272|081|S|change in the amount of urine), muscle spasms/weakness.||
1272|082|S|   A very serious allergic reaction to this drug is rare.||
1272|083|S|However, get medical help right away if you notice any symptoms||
1272|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1272|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1272|086|S|breathing.||
1272|087|S|   This is not a complete list of possible side effects. If you||
1272|088|S|notice other effects not listed above, contact your doctor or||
1272|089|S|pharmacist.||
1272|090|S|   In the US -||
1272|091|S|   Call your doctor for medical advice about side effects. You||
1272|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1272|093|S|www.fda.gov/medwatch.||
1272|094|S|   In Canada - Call your doctor for medical advice about side||
1272|095|S|effects. You may report side effects to Health Canada at||
1272|096|S|1-866-234-2345.||
1272|097|B|||
1272|098|P|PRECAUTIONS:  Before receiving this medication, tell your doctor||
1272|099|P|or pharmacist if you are allergic to it; or if you have ever had||
1272|100|P|a severe reaction to it; or if you have any other allergies. This||
1272|101|P|product may contain inactive ingredients, which can cause||
1272|102|P|allergic reactions or other problems. Talk to your pharmacist for||
1272|103|P|more details.||
1272|104|P|   Before using this medication, tell your doctor or pharmacist||
1272|105|P|your medical history, especially of: breathing problems (such as||
1272|106|P|chronic obstructive pulmonary disease - COPD, asthma), liver||
1272|107|P|disease (such as hepatitis B), heart disease (such as chest pain,||
1272|108|P|heart attack), immune system problems (such as HIV).||
1272|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1272|110|P|can make you more dizzy. Do not drive, use machinery, or do||
1272|111|P|anything that needs alertness until you can do it safely. Limit||
1272|112|P|alcoholic beverages. Talk to your doctor if you are using||
1272|113|P|marijuana (cannabis).||
1272|114|P|   Before having surgery, tell your doctor or dentist about all||
1272|115|P|the products you use (including prescription drugs,||
1272|116|P|nonprescription drugs, and herbal products).||
1272|117|P|   Ofatumumab can make you more likely to get infections or may||
1272|118|P|make current infections worse. Stay away from anyone who has an||
1272|119|P|infection that may easily spread (such as chickenpox, COVID-19,||
1272|120|P|measles, flu). Talk to your doctor if you have been exposed to an||
1272|121|P|infection or for more details.||
1272|122|P|   Tell your health care professional that you are using||
1272|123|P|ofatumumab before having any immunizations/vaccinations. Avoid||
1272|124|P|contact with people who have recently received live vaccines||
1272|125|P|(such as flu vaccine inhaled through the nose).||
1272|126|P|   To lower the chance of getting cut, bruised, or injured, use||
1272|127|P|caution with sharp objects like razors and nail cutters, and||
1272|128|P|avoid activities such as contact sports.||
1272|129|P|   During pregnancy, this medication should be used only when||
1272|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
1272|131|P|   It is unknown if this drug passes into breast milk. Consult||
1272|132|P|your doctor before breastfeeding.||
1272|133|B|||
1272|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1272|135|I|medications work or increase your risk for serious side effects.||
1272|136|I|This document does not contain all possible drug interactions.||
1272|137|I|Keep a list of all the products you use (including||
1272|138|I|prescription/nonprescription drugs and herbal products) and share||
1272|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
1272|140|I|the dosage of any medicines without your doctor's approval.||
1272|141|I|   Some products that may interact with this drug include: other||
1272|142|I|drugs that weaken the immune system/increase the risk of||
1272|143|I|infection (such as natalizumab, rituximab).||
1272|144|B|||
1272|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1272|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1272|147|O|poison control center right away. US residents can call||
1272|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1272|149|B|||
1272|150|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1272|151|N|platelets, liver/kidney function, blood mineral levels, hepatitis||
1272|152|N|B virus) should be done while you are using this medication. Keep||
1272|153|N|all medical and lab appointments. Consult your doctor for more||
1272|154|N|details.||
1272|155|B|||
1272|156|D|MISSED DOSE:  It is important to get each dose of this medication||
1272|157|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1272|158|D|right away for a new dosing schedule.||
1272|159|B|||
1272|160|R|STORAGE:  Not applicable. This medication is given in a hospital||
1272|161|R|or clinic and will not be stored at home.||
1272|162|B|||
1272|163|M|MEDICAL ALERT:  Your condition can cause complications in a||
1272|164|M|medical emergency. For information about enrolling in MedicAlert,||
1272|165|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1272|166|B|||
1272|167|A|Information last revised April 2025.||
1272|168|A|Copyright(c) 2025 First Databank, Inc.||
1272|169|B|||
1273|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1273|002|Z|does NOT have all possible information about this product. This||
1273|003|Z|information does not assure that this product is safe, effective,||
1273|004|Z|or appropriate for you. This information is not individual||
1273|005|Z|medical advice and does not substitute for the advice of your||
1273|006|Z|health care professional. Always ask your health care||
1273|007|Z|professional for complete information about this product and your||
1273|008|Z|specific health needs.||
1273|009|B|||
1273|010|T|EXEMESTANE - ORAL||
1273|011|F|(ex-em-ESS-tain)||
1273|012|B|||
1273|013|C|COMMON BRAND NAME(S): Aromasin||
1273|014|B|||
1273|015|U|USES:  This medication is used to treat certain types of breast||
1273|016|U|cancer (such as hormone-receptor-positive breast cancer) in women||
1273|017|U|after menopause. Exemestane is also used to help prevent the||
1273|018|U|cancer from returning. Some breast cancers are made to grow||
1273|019|U|faster by a natural hormone called estrogen. Exemestane decreases||
1273|020|U|the amount of estrogen the body makes and helps to slow or||
1273|021|U|reverse the growth of these breast cancers.||
1273|022|U|   Exemestane is usually not used in women of childbearing age.||
1273|023|B|||
1273|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1273|025|H|from your pharmacist before you start using exemestane and each||
1273|026|H|time you get a refill. If you have any questions, ask your doctor||
1273|027|H|or pharmacist.||
1273|028|H|   Take this medication by mouth with food (after a meal) as||
1273|029|H|directed by your doctor, usually once daily.||
1273|030|H|   The dosage is based on your medical condition, response to||
1273|031|H|treatment, and other medications you may be taking. Be sure to||
1273|032|H|tell your doctor and pharmacist about all the products you use||
1273|033|H|(including prescription drugs, nonprescription drugs, and herbal||
1273|034|H|products).||
1273|035|H|   Use this medication regularly to get the most benefit from it.||
1273|036|H|To help you remember, take it at the same time each day.||
1273|037|H|   Since this drug can be absorbed through the skin and lungs,||
1273|038|H|women who are pregnant or who may become pregnant should not||
1273|039|H|handle this medication or breathe the dust from the tablets. (See||
1273|040|H|also Precautions section.)||
1273|041|H|   Tell your doctor right away if your condition gets worse (such||
1273|042|H|as you get new breast lumps).||
1273|043|B|||
1273|044|S|SIDE EFFECTS:  Hot flashes, hair loss, bone pain, tiredness,||
1273|045|S|unusual sweating, nausea, diarrhea, dizziness, and trouble||
1273|046|S|sleeping may occur. If any of these effects last or get worse,||
1273|047|S|notify your doctor or pharmacist promptly.||
1273|048|S|   Remember that this medication has been prescribed because your||
1273|049|S|doctor has judged that the benefit to you is greater than the||
1273|050|S|risk of side effects. Many people using this medication do not||
1273|051|S|have serious side effects.||
1273|052|S|   Tell your doctor right away if you have any serious side||
1273|053|S|effects, including: nausea/vomiting that doesn't stop, bone||
1273|054|S|fractures, pain/swelling of the joint/muscle/tendon, mental/mood||
1273|055|S|changes (such as depression, anxiety), vaginal bleeding, unusual||
1273|056|S|tiredness, dark urine, yellowing eyes/skin.||
1273|057|S|   This medication (and cancer) may rarely cause serious problems||
1273|058|S|from blood clots (such as heart attack, stroke, blood clots in||
1273|059|S|the lungs or legs). Get medical help right away if you have:||
1273|060|S|shortness of breath/rapid breathing, chest/jaw/left arm pain,||
1273|061|S|confusion, sudden dizziness/fainting, pain/swelling/warmth in the||
1273|062|S|groin/calf, trouble speaking, weakness on one side of the body,||
1273|063|S|sudden vision changes, sudden/severe headaches, unusual sweating.||
1273|064|S|   A very serious allergic reaction to this drug is rare.||
1273|065|S|However, get medical help right away if you notice any symptoms||
1273|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1273|067|S|(especially of the face/tongue/throat/neck), severe dizziness,||
1273|068|S|trouble breathing.||
1273|069|S|   This is not a complete list of possible side effects. If you||
1273|070|S|notice other effects not listed above, contact your doctor or||
1273|071|S|pharmacist.||
1273|072|S|   In the US -||
1273|073|S|   Call your doctor for medical advice about side effects. You||
1273|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1273|075|S|www.fda.gov/medwatch.||
1273|076|S|   In Canada - Call your doctor for medical advice about side||
1273|077|S|effects. You may report side effects to Health Canada at||
1273|078|S|1-866-234-2345.||
1273|079|B|||
1273|080|P|PRECAUTIONS:  Before taking exemestane, tell your doctor or||
1273|081|P|pharmacist if you are allergic to it; or if you have any other||
1273|082|P|allergies. This product may contain inactive ingredients, which||
1273|083|P|can cause allergic reactions or other problems. Talk to your||
1273|084|P|pharmacist for more details.||
1273|085|P|   Before using this medication, tell your doctor or pharmacist||
1273|086|P|your medical history, especially of: high blood fats||
1273|087|P|(cholesterol), bone problems (such as osteopenia, osteoporosis),||
1273|088|P|stroke or blood clots, heart disease (such as chest pain, heart||
1273|089|P|attack, heart failure), high blood pressure, kidney problems,||
1273|090|P|liver problems.||
1273|091|P|   This drug may make you dizzy or tired. Alcohol or marijuana||
1273|092|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
1273|093|P|or do anything that needs alertness until you can do it safely.||
1273|094|P|Limit alcoholic beverages. Talk to your doctor if you are using||
1273|095|P|marijuana (cannabis).||
1273|096|P|   Before having surgery, tell your doctor or dentist about all||
1273|097|P|the products you use (including prescription drugs,||
1273|098|P|nonprescription drugs, and herbal products).||
1273|099|P|   This medication must not be used during pregnancy. It may harm||
1273|100|P|an unborn baby. Exemestane is used mainly in women after||
1273|101|P|menopause. If you are near menopause or have not gone through||
1273|102|P|menopause and your doctor has prescribed this for you, discuss||
1273|103|P|with your doctor whether you need to use reliable forms of birth||
1273|104|P|control. If you do, keep using birth control for 1 month after||
1273|105|P|stopping treatment with this medication. Do not use birth control||
1273|106|P|products containing estrogen. Consult your doctor for more||
1273|107|P|details. If you become pregnant or think you may be pregnant,||
1273|108|P|tell your doctor right away. (See also How to Use section.)||
1273|109|P|   It is unknown if this medication passes into breast milk.||
1273|110|P|Because of the possible risk to the infant, breastfeeding is not||
1273|111|P|recommended while using this medication and for 1 month after the||
1273|112|P|last dose. Consult your doctor before breastfeeding.||
1273|113|B|||
1273|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1273|115|I|medications work or increase your risk for serious side effects.||
1273|116|I|This document does not contain all possible drug interactions.||
1273|117|I|Keep a list of all the products you use (including||
1273|118|I|prescription/nonprescription drugs and herbal products) and share||
1273|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
1273|120|I|the dosage of any medicines without your doctor's approval.||
1273|121|I|   Some products that may interact with this drug include:||
1273|122|I|estrogens (such as ethinyl estradiol, conjugated estrogens),||
1273|123|I|estrogen blockers (such as anastrozole, tamoxifen), tibolone.||
1273|124|B|||
1273|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1273|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1273|127|O|poison control center right away. US residents can call||
1273|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1273|129|B|||
1273|130|N|NOTES:  Do not share this medication with others.||
1273|131|N|   Lab and/or medical tests (such as bone density tests,||
1273|132|N|cholesterol levels, liver function) should be done while you are||
1273|133|N|taking this medication. Keep all medical and lab appointments.||
1273|134|N|Consult your doctor for more details.||
1273|135|N|   This medication can increase the risk of bone loss||
1273|136|N|(osteoporosis). Talk with your doctor about your risk, and about||
1273|137|N|available treatments for osteoporosis. Lifestyle changes that may||
1273|138|N|help reduce the risk of bone problems include doing||
1273|139|N|weight-bearing exercise, stopping smoking, limiting alcohol, and||
1273|140|N|getting enough calcium and vitamin D.||
1273|141|B|||
1273|142|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1273|143|D|remember. If it is near the time of the next dose, skip the||
1273|144|D|missed dose. Take your next dose at the regular time. Do not||
1273|145|D|double the dose to catch up.||
1273|146|B|||
1273|147|R|STORAGE:  Store at room temperature away from light and moisture.||
1273|148|R|Do not store in the bathroom. Keep all medications away from||
1273|149|R|children and pets.||
1273|150|R|   Do not flush medications down the toilet or pour them into a||
1273|151|R|drain unless instructed to do so. Properly discard this product||
1273|152|R|when it is expired or no longer needed. Consult your pharmacist||
1273|153|R|or local waste disposal company.||
1273|154|B|||
1273|155|A|Information last revised September 2025.||
1273|156|A|Copyright(c) 2025 First Databank, Inc.||
1273|157|B|||
1274|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1274|002|Z|does NOT have all possible information about this product. This||
1274|003|Z|information does not assure that this product is safe, effective,||
1274|004|Z|or appropriate for you. This information is not individual||
1274|005|Z|medical advice and does not substitute for the advice of your||
1274|006|Z|health care professional. Always ask your health care||
1274|007|Z|professional for complete information about this product and your||
1274|008|Z|specific health needs.||
1274|009|B|||
1274|010|T|OLANZAPINE/FLUOXETINE - ORAL||
1274|011|F|(oh-LAN-za-peen/floo-OX-e-teen)||
1274|012|B|||
1274|013|C|COMMON BRAND NAME(S): Symbyax||
1274|014|B|||
1274|015|W|WARNING:  Antidepressant medications are used to treat a variety||
1274|016|W|of conditions, including depression and other mental/mood||
1274|017|W|disorders. These medications can help prevent suicidal||
1274|018|W|thoughts/attempts and provide other important benefits. However,||
1274|019|W|studies have shown that a small number of people (especially||
1274|020|W|people younger than 25) who take antidepressants for any||
1274|021|W|condition may experience worsening depression, other mental/mood||
1274|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
1274|023|W|talk with the doctor about the risks and benefits of||
1274|024|W|antidepressant medication (especially for people younger than||
1274|025|W|25), even if treatment is not for a mental/mood condition.||
1274|026|W|   Tell the doctor right away if you notice worsening||
1274|027|W|depression/other psychiatric conditions, unusual behavior changes||
1274|028|W|(including possible suicidal thoughts/attempts), or other||
1274|029|W|mental/mood changes (including new/worsening anxiety, panic||
1274|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1274|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
1274|032|W|especially watchful for these symptoms when a new antidepressant||
1274|033|W|is started or when the dose is changed.||
1274|034|W|   There may be a slightly increased risk of serious, possibly||
1274|035|W|fatal side effects (such as stroke, heart failure, fast/irregular||
1274|036|W|heartbeat, pneumonia) when this medication is used by older||
1274|037|W|adults with dementia. This medication is not approved for the||
1274|038|W|treatment of dementia-related behavior problems. Discuss the||
1274|039|W|risks and benefits of this medication, as well as other effective||
1274|040|W|and possibly safer treatments for dementia-related behavior||
1274|041|W|problems, with the doctor.||
1274|042|B|||
1274|043|U|USES:  This combination medication is used to treat certain||
1274|044|U|mental/mood disorders (such as depression associated with bipolar||
1274|045|U|disorder). It is also used to treat depression that has not||
1274|046|U|responded to other medications. Olanzapine belongs to a class of||
1274|047|U|drugs known as atypical antipsychotics. Fluoxetine belongs to a||
1274|048|U|class of drugs known as selective serotonin reuptake inhibitors||
1274|049|U|(SSRIs). Olanzapine/fluoxetine works by helping to restore the||
1274|050|U|balance of certain natural substances (such as serotonin) in the||
1274|051|U|brain.||
1274|052|U|   Talk to the doctor about the risks and benefits of treatment||
1274|053|U|(especially when used in teenagers). See also Precautions||
1274|054|U|section.||
1274|055|B|||
1274|056|H|HOW TO USE:  Read the Medication Guide provided by your||
1274|057|H|pharmacist before you start using olanzapine/fluoxetine and each||
1274|058|H|time you get a refill. If you have any questions, consult your||
1274|059|H|doctor or pharmacist.||
1274|060|H|   Take this medication by mouth with or without food as directed||
1274|061|H|by your doctor, usually once daily in the evening.||
1274|062|H|   The dosage is based on your medical condition and response to||
1274|063|H|treatment.||
1274|064|H|   Use this medication regularly in order to get the most benefit||
1274|065|H|from it. Remember to use it at the same time each day.||
1274|066|H|   It may take up to several weeks before the full benefit of||
1274|067|H|this drug takes effect. Keep taking this medication even if you||
1274|068|H|feel well. Do not stop taking this medication without consulting||
1274|069|H|your doctor. Some conditions may become worse when the drug is||
1274|070|H|abruptly stopped. Your dose may need to be gradually decreased.||
1274|071|H|   If your condition lasts or gets worse, contact your doctor or||
1274|072|H|pharmacist.||
1274|073|B|||
1274|074|S|SIDE EFFECTS:  See also the Warning section.||
1274|075|S|   Dizziness, lightheadedness, drowsiness, diarrhea, dry mouth,||
1274|076|S|constipation, increased appetite, weight gain, or trouble||
1274|077|S|sleeping may occur. If any of these effects last or get worse,||
1274|078|S|tell your doctor or pharmacist promptly.||
1274|079|S|   Dizziness and lightheadedness can increase the risk of||
1274|080|S|falling. Get up slowly when rising from a sitting or lying||
1274|081|S|position.||
1274|082|S|   Remember that this medication has been prescribed because your||
1274|083|S|doctor has judged that the benefit to you is greater than the||
1274|084|S|risk of side effects. Many people using this medication do not||
1274|085|S|have serious side effects.||
1274|086|S|   Tell your doctor right away if you have any serious side||
1274|087|S|effects, including: unusual or severe mental/mood changes (such||
1274|088|S|as confusion, nervousness, trouble concentrating, rare thoughts||
1274|089|S|of suicide), swelling hands/ankles/feet, restlessness, shaking||
1274|090|S|(tremor), inability to keep still, decreased interest in sex,||
1274|091|S|changes in sexual ability, trouble urinating, easy||
1274|092|S|bleeding/bruising, muscle spasm, yellowing eyes/skin, severe||
1274|093|S|stomach/abdominal pain, slow heartbeat, interrupted breathing||
1274|094|S|during sleep.||
1274|095|S|   Get medical help right away if you have any very serious side||
1274|096|S|effects, including: black stools, vomit that looks like coffee||
1274|097|S|grounds, severe headache, seizures, eye pain/swelling/redness,||
1274|098|S|widened pupils, vision changes (such as seeing rainbows around||
1274|099|S|lights at night, blurred vision).||
1274|100|S|   This drug may rarely make your blood sugar rise, which can||
1274|101|S|cause or worsen diabetes. Tell your doctor right away if you have||
1274|102|S|symptoms of high blood sugar such as increased thirst/urination.||
1274|103|S|If you already have diabetes, check your blood sugar regularly as||
1274|104|S|directed and share the results with your doctor. Your doctor may||
1274|105|S|need to adjust your diabetes medication, exercise program, or||
1274|106|S|diet when you start or stop this medication.||
1274|107|S|   This drug may also cause significant weight gain and a rise in||
1274|108|S|your blood cholesterol (or triglyceride) levels, especially in||
1274|109|S|teenagers. These effects, along with diabetes, may increase your||
1274|110|S|risk for developing heart disease. Discuss the risks and benefits||
1274|111|S|of treatment with your doctor. (See also Notes section.)||
1274|112|S|   This medication may increase serotonin and rarely cause a very||
1274|113|S|serious condition called serotonin syndrome/toxicity. The risk||
1274|114|S|increases if you are also taking other drugs that increase||
1274|115|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1274|116|S|take (see Drug Interactions section). Get medical help right away||
1274|117|S|if you develop some of the following symptoms: fast heartbeat,||
1274|118|S|hallucinations, loss of coordination, severe dizziness, severe||
1274|119|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1274|120|S|unusual agitation/restlessness.||
1274|121|S|   This medication may rarely cause a very serious condition||
1274|122|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1274|123|S|right away if you have any of the following symptoms: fever,||
1274|124|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1274|125|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1274|126|S|signs of kidney problems (such as change in the amount of urine).||
1274|127|S|   Olanzapine may rarely cause a condition known as tardive||
1274|128|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1274|129|S|your doctor right away if you develop any unusual/uncontrolled||
1274|130|S|movements (especially of the face/lips/tongue).||
1274|131|S|   In rare cases, this medication may increase your blood level||
1274|132|S|of a certain hormone (prolactin). For females, this rare increase||
1274|133|S|in prolactin levels may result in unwanted breast milk,||
1274|134|S|irregular/stopped menstrual periods, or difficulty becoming||
1274|135|S|pregnant. For males, it may result in decreased sexual ability,||
1274|136|S|inability to produce sperm, or enlarged breasts. If you develop||
1274|137|S|any of these symptoms, tell your doctor right away.||
1274|138|S|   Rarely, males may have a painful or prolonged erection lasting||
1274|139|S|4 or more hours. If this occurs, stop using this drug and get||
1274|140|S|medical help right away, or permanent problems could occur.||
1274|141|S|   A very serious allergic reaction to this drug is rare.||
1274|142|S|However, get medical help right away if you notice any symptoms||
1274|143|S|of a serious allergic reaction, including: fever, swollen lymph||
1274|144|S|nodes, rash, itching/swelling (especially of the||
1274|145|S|face/tongue/throat), severe dizziness, trouble breathing.||
1274|146|S|   This is not a complete list of possible side effects. If you||
1274|147|S|notice other effects not listed above, contact your doctor or||
1274|148|S|pharmacist.||
1274|149|S|   In the US -||
1274|150|S|   Call your doctor for medical advice about side effects. You||
1274|151|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1274|152|S|www.fda.gov/medwatch.||
1274|153|S|   In Canada - Call your doctor for medical advice about side||
1274|154|S|effects. You may report side effects to Health Canada at||
1274|155|S|1-866-234-2345.||
1274|156|B|||
1274|157|P|PRECAUTIONS:  Before taking olanzapine/fluoxetine, tell your||
1274|158|P|doctor or pharmacist if you are allergic to olanzapine or||
1274|159|P|fluoxetine; or if you have any other allergies. This product may||
1274|160|P|contain inactive ingredients, which can cause allergic reactions||
1274|161|P|or other problems. Talk to your pharmacist for more details.||
1274|162|P|   Before using this medication, tell your doctor or pharmacist||
1274|163|P|your medical history, especially of: bleeding problems, personal||
1274|164|P|or family history of suicide attempts, breast cancer,||
1274|165|P|stomach/intestinal problems (such as blockage, chronic||
1274|166|P|constipation, paralytic ileus), kidney disease, liver problems,||
1274|167|P|low blood pressure, neuroleptic malignant syndrome, glaucoma||
1274|168|P|(narrow angle), difficulty urinating (for example, due to||
1274|169|P|enlarged prostate), seizures, brain problems (such as dementia,||
1274|170|P|stroke), dehydration, low white blood cell count, personal or||
1274|171|P|family history of diabetes, heart disease, high||
1274|172|P|cholesterol/triglyceride levels, breathing trouble during sleep||
1274|173|P|(sleep apnea).||
1274|174|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1274|175|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1274|176|P|machinery, or do anything that needs alertness until you can do||
1274|177|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1274|178|P|are using marijuana (cannabis).||
1274|179|P|   This medication can make it harder to control your body||
1274|180|P|temperature. Avoid activities that might cause you to overheat||
1274|181|P|(such as doing strenuous work, exercising in hot weather, or||
1274|182|P|using hot tubs). Drink plenty of fluids to avoid becoming||
1274|183|P|dehydrated.||
1274|184|P|   Teenagers may be more sensitive to the side effects of this||
1274|185|P|drug, especially weight gain, and also increased amounts of||
1274|186|P|cholesterol, triglycerides and prolactin. See also Side Effects||
1274|187|P|section for more details.||
1274|188|P|   Older adults may be more sensitive to the side effects of this||
1274|189|P|drug, especially bleeding, drowsiness, constipation, trouble||
1274|190|P|urinating, confusion, dizziness, and lightheadedness. Older||
1274|191|P|adults may also be more likely to develop low sodium in the||
1274|192|P|blood, especially if they are taking "water pills" (diuretics).||
1274|193|P|Drowsiness, confusion, dizziness, and lightheadedness can||
1274|194|P|increase the risk of falling.||
1274|195|P|   During pregnancy, this medication should be used only when||
1274|196|P|clearly needed. Babies born to mothers who have used this drug||
1274|197|P|during the last 3 months of pregnancy may rarely develop symptoms||
1274|198|P|including muscle stiffness or shakiness, drowsiness,||
1274|199|P|feeding/breathing difficulties, or constant crying. If you notice||
1274|200|P|any of these symptoms in your newborn especially during their||
1274|201|P|first month, tell the doctor right away.||
1274|202|P|   Since untreated mental/mood problems (such as depression,||
1274|203|P|bipolar disorder) can be a serious condition, do not stop taking||
1274|204|P|this medication unless directed by your doctor. If you are||
1274|205|P|planning pregnancy, become pregnant, or think you may be||
1274|206|P|pregnant, immediately discuss with your doctor the benefits and||
1274|207|P|risks of using this medication during pregnancy.||
1274|208|P|   This drug passes into breast milk and may have undesirable||
1274|209|P|effects on a nursing infant. Tell the doctor right away if your||
1274|210|P|baby develops symptoms such as muscle stiffness or shakiness,||
1274|211|P|unusual sleepiness, or difficulty feeding. Consult your doctor||
1274|212|P|before breastfeeding.||
1274|213|B|||
1274|214|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1274|215|I|medications work or increase your risk for serious side effects.||
1274|216|I|This document does not contain all possible drug interactions.||
1274|217|I|Keep a list of all the products you use (including||
1274|218|I|prescription/nonprescription drugs and herbal products) and share||
1274|219|I|it with your doctor and pharmacist. Do not start, stop, or change||
1274|220|I|the dosage of any medicines without your doctor's approval.||
1274|221|I|   Fluoxetine (one of the drugs in this medication) can stay in||
1274|222|I|your body for many weeks after your last dose and may interact||
1274|223|I|with many other medications. If you have taken this medication in||
1274|224|I|the previous 5 weeks, consult your doctor or pharmacist before||
1274|225|I|using any other medication.||
1274|226|I|   Some products that may interact with this drug are:||
1274|227|I|fosamprenavir/ritonavir, metoprolol, "water pills" (diuretics||
1274|228|I|such as furosemide), other drugs that can cause bleeding/bruising||
1274|229|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
1274|230|I|ibuprofen/naproxen, "blood thinners" such as||
1274|231|I|dabigatran/warfarin), drugs for high blood pressure, medicines||
1274|232|I|for Parkinson's disease (such as cabergoline).||
1274|233|I|   Taking MAO inhibitors with his medication may cause a serious||
1274|234|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1274|235|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1274|236|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1274|237|I|selegiline, tranylcypromine) during treatment with this||
1274|238|I|medication. Most MAO inhibitors should also not be taken for 2||
1274|239|I|weeks before and at least 5 weeks after treatment with this||
1274|240|I|medication. Ask your doctor when to start or stop taking this||
1274|241|I|medication.||
1274|242|I|   This medication can slow down the removal of other medications||
1274|243|I|from your body, which may affect how they work. Examples of||
1274|244|I|affected drugs include cimetidine, phenytoin, pimozide,||
1274|245|I|vinblastine, antipsychotics (such as aripiprazole, clozapine,||
1274|246|I|haloperidol, perphenazine, thioridazine), antiarrhythmics (such||
1274|247|I|as propafenone, flecainide), tricyclic antidepressants (such as||
1274|248|I|desipramine, imipramine), among others.||
1274|249|I|   Aspirin can increase the risk of bleeding when used with this||
1274|250|I|medication. However, if your doctor has told you to take low-dose||
1274|251|I|aspirin to prevent heart attack or stroke (usually 81-162||
1274|252|I|milligrams a day), you should keep taking the aspirin unless your||
1274|253|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1274|254|I|details.||
1274|255|I|   The risk of serotonin syndrome/toxicity increases if you are||
1274|256|I|also taking other drugs that increase serotonin. Examples include||
1274|257|I|street drugs such as MDMA/"ecstasy" St. John's wort, certain||
1274|258|I|antidepressants (including other SSRIs such as||
1274|259|I|citalopram/paroxetine, SNRIs such as duloxetine/venlafaxine),||
1274|260|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
1274|261|I|may be more likely when you start or increase the dose of these||
1274|262|I|drugs.||
1274|263|I|   Tell your doctor or pharmacist if you are taking other||
1274|264|I|products that cause drowsiness such as opioid pain or cough||
1274|265|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1274|266|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1274|267|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1274|268|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1274|269|I|diphenhydramine).||
1274|270|I|   Check the labels on all your medicines (such as allergy or||
1274|271|I|cough-and-cold products) because they may contain ingredients||
1274|272|I|that cause drowsiness. Ask your pharmacist about using those||
1274|273|I|products safely.||
1274|274|I|   Cigarette smoking may decrease blood levels of this||
1274|275|I|medication. Tell your doctor if you smoke or if you have recently||
1274|276|I|stopped smoking.||
1274|277|I|   This medication may interfere with certain medical/lab tests||
1274|278|I|(such as brain scan for Parkinson's disease), possibly causing||
1274|279|I|false test results. Make sure lab personnel and all your doctors||
1274|280|I|know you use this drug.||
1274|281|B|||
1274|282|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1274|283|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1274|284|O|poison control center right away. US residents can call||
1274|285|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1274|286|O|Symptoms of overdose may include: fast/irregular heartbeat,||
1274|287|O|severe dizziness, seizures, fainting.||
1274|288|B|||
1274|289|N|NOTES:  Do not share this medication with others.||
1274|290|N|   Lab and/or medical tests (such as liver function, blood sugar,||
1274|291|N|weight, blood pressure, blood cholesterol/triglyceride levels)||
1274|292|N|should be done while you are taking this medication. Keep all||
1274|293|N|medical and lab appointments. Consult your doctor for more||
1274|294|N|details.||
1274|295|B|||
1274|296|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1274|297|D|If it is near the time of the next dose, skip the missed dose.||
1274|298|D|Use your next dose at the regular time. Do not double the dose to||
1274|299|D|catch up.||
1274|300|B|||
1274|301|R|STORAGE:  Store at room temperature away from light and moisture.||
1274|302|R|Do not store in the bathroom. Keep all medications away from||
1274|303|R|children and pets.||
1274|304|R|   Do not flush medications down the toilet or pour them into a||
1274|305|R|drain unless instructed to do so. Properly discard this product||
1274|306|R|when it is expired or no longer needed. Consult your pharmacist||
1274|307|R|or local waste disposal company.||
1274|308|B|||
1274|309|A|Information last revised February 2025.||
1274|310|A|Copyright(c) 2025 First Databank, Inc.||
1274|311|B|||
1275|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1275|002|Z|does NOT have all possible information about this product. This||
1275|003|Z|information does not assure that this product is safe, effective,||
1275|004|Z|or appropriate for you. This information is not individual||
1275|005|Z|medical advice and does not substitute for the advice of your||
1275|006|Z|health care professional. Always ask your health care||
1275|007|Z|professional for complete information about this product and your||
1275|008|Z|specific health needs.||
1275|009|B|||
1275|010|T|PROBIOTICS - ORAL||
1275|011|B|||
1275|012|U|USES:  Probiotics contain different types of micro-organisms such||
1275|013|U|as yeast (saccharomyces boulardii) and bacteria (such as||
1275|014|U|lactobacillus, bifidobacterium). Micro-organisms (flora) are||
1275|015|U|naturally found in the stomach/intestines/vagina. Some conditions||
1275|016|U|(such as antibiotic use, travel) can change the normal balance of||
1275|017|U|bacteria/yeast. Probiotics are used to improve digestion and||
1275|018|U|restore normal flora.||
1275|019|U|   Probiotics have been used to treat bowel problems (such as||
1275|020|U|diarrhea, irritable bowel), eczema, vaginal yeast infections,||
1275|021|U|lactose intolerance, and urinary tract infections.||
1275|022|U|   Probiotics are available in foods (such as yogurt, milk,||
1275|023|U|juices, soy beverages) and as dietary supplements (capsules,||
1275|024|U|tablets, powders). Different products have different uses. Check||
1275|025|U|the label for information on uses for your particular product.||
1275|026|U|   Some diet supplement products have been found to contain||
1275|027|U|possibly harmful impurities/additives. Check with your pharmacist||
1275|028|U|for more details regarding the particular brand you use.||
1275|029|U|   The FDA has not reviewed this product for safety or||
1275|030|U|effectiveness. Consult your doctor or pharmacist for more||
1275|031|U|details.||
1275|032|B|||
1275|033|H|HOW TO USE:  Follow all directions on the product package. Refer||
1275|034|H|to the label directions for your specific product to see if the||
1275|035|H|dose should be swallowed whole, chewed, sprinkled onto food or||
1275|036|H|mixed with liquid. If you are using the liquid form of this||
1275|037|H|medication, carefully measure the dose using a special measuring||
1275|038|H|device/spoon. Do not use a household spoon because you may not||
1275|039|H|get the correct dose. If you have any questions, ask your doctor||
1275|040|H|or pharmacist.||
1275|041|H|   Some probiotic products may contain live bacteria (such as||
1275|042|H|bifidobacteria). Antibiotics may prevent these products from||
1275|043|H|working well. Take any product containing live bacteria at least||
1275|044|H|2 to 3 hours before or after taking antibiotics. Follow the||
1275|045|H|directions for your specific product.||
1275|046|H|   If you are taking this product for diarrhea due to||
1275|047|H|antibiotics, do not use it if you have a high fever or for more||
1275|048|H|than 2 days, unless directed by your doctor. You may have a||
1275|049|H|serious problem that requires medical treatment.||
1275|050|H|   If your condition lasts or gets worse, or if you think you may||
1275|051|H|have a serious medical problem, get medical help right away.||
1275|052|B|||
1275|053|S|SIDE EFFECTS:  An increase in stomach gas or bloating may occur.||
1275|054|S|If this effect lasts or gets worse, notify your doctor or||
1275|055|S|pharmacist promptly.||
1275|056|S|   Tell your doctor right away if you have any serious side||
1275|057|S|effects, including: signs of infection (such as sore throat that||
1275|058|S|doesn't go away, fever, chills).||
1275|059|S|   A very serious allergic reaction to this product is rare.||
1275|060|S|However, get medical help right away if you notice any symptoms||
1275|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1275|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1275|063|S|breathing.||
1275|064|S|   This is not a complete list of possible side effects. If you||
1275|065|S|notice other effects not listed above, contact your doctor or||
1275|066|S|pharmacist.||
1275|067|S|   In the US -||
1275|068|S|   Call your doctor for medical advice about side effects. You||
1275|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1275|070|S|www.fda.gov/medwatch.||
1275|071|S|   In Canada - Call your doctor for medical advice about side||
1275|072|S|effects. You may report side effects to Health Canada at||
1275|073|S|1-866-234-2345.||
1275|074|B|||
1275|075|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1275|076|P|pharmacist if you are allergic to it; or if you have any other||
1275|077|P|allergies. This product may contain inactive ingredients, which||
1275|078|P|can cause allergic reactions or other problems. Talk to your||
1275|079|P|pharmacist for more details.||
1275|080|P|   If you have any of the following health problems, consult your||
1275|081|P|doctor or pharmacist before using this product: diarrhea lasting||
1275|082|P|more than 2 days (especially if you also have a high fever),||
1275|083|P|weakened immune system (such as due to chemotherapy, HIV||
1275|084|P|infection), recurring vaginal infections, recurring urinary tract||
1275|085|P|infections.||
1275|086|P|   Liquid products, foods, powders, or chewable tablets may||
1275|087|P|contain sugar and/or aspartame. Caution is advised if you have||
1275|088|P|diabetes, phenylketonuria (PKU), or any other condition that||
1275|089|P|requires you to limit/avoid these substances in your diet. Ask||
1275|090|P|your doctor or pharmacist about using this product safely.||
1275|091|P|   Before having surgery, tell your doctor or dentist about all||
1275|092|P|the products you use (including prescription drugs,||
1275|093|P|nonprescription drugs, and herbal products).||
1275|094|P|   During pregnancy, this product should be used only when||
1275|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1275|096|P|   It is unknown if this product passes into breast milk. Consult||
1275|097|P|your doctor before breastfeeding.||
1275|098|B|||
1275|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1275|100|I|medications work or increase your risk for serious side effects.||
1275|101|I|This document does not contain all possible drug interactions.||
1275|102|I|Keep a list of all the products you use (including||
1275|103|I|prescription/nonprescription drugs and herbal products) and share||
1275|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1275|105|I|the dosage of any medicines without your doctor's approval.||
1275|106|I|   Some medications that may interact with certain probiotics||
1275|107|I|include: antibiotics, antifungals (such as clotrimazole,||
1275|108|I|ketoconazole, griseofulvin, nystatin).||
1275|109|B|||
1275|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1275|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1275|112|O|poison control center right away. US residents can call||
1275|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1275|114|B|||
1275|115|N|NOTES:  Keep all medical and lab appointments.||
1275|116|N|   Some brands may also contain other ingredients, such as fiber||
1275|117|N|or inulin. Ask your doctor or pharmacist if you have questions||
1275|118|N|about the ingredients in your brand.||
1275|119|B|||
1275|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1275|121|D|remember. If it is near the time of the next dose, skip the||
1275|122|D|missed dose. Take your next dose at the regular time. Do not||
1275|123|D|double the dose to catch up.||
1275|124|B|||
1275|125|R|STORAGE:  Different types of probiotics may have different||
1275|126|R|storage needs. Some may require refrigeration while others should||
1275|127|R|not be refrigerated. Check the product package for instructions||
1275|128|R|on how to store your product. If you have any questions about||
1275|129|R|storage, ask your pharmacist. Keep all medications away from||
1275|130|R|children and pets.||
1275|131|R|   Do not flush medications down the toilet or pour them into a||
1275|132|R|drain unless instructed to do so. Properly discard this product||
1275|133|R|when it is expired or no longer needed. Consult your pharmacist||
1275|134|R|or local waste disposal company.||
1275|135|B|||
1275|136|A|Information last revised April 2025.||
1275|137|A|Copyright(c) 2025 First Databank, Inc.||
1275|138|B|||
1276|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1276|002|Z|does NOT have all possible information about this product. This||
1276|003|Z|information does not assure that this product is safe, effective,||
1276|004|Z|or appropriate for you. This information is not individual||
1276|005|Z|medical advice and does not substitute for the advice of your||
1276|006|Z|health care professional. Always ask your health care||
1276|007|Z|professional for complete information about this product and your||
1276|008|Z|specific health needs.||
1276|009|B|||
1276|010|T|CHENODIOL - ORAL||
1276|011|F|(KEE-noe-DYE-ol)||
1276|012|B|||
1276|013|C|COMMON BRAND NAME(S): Chenodal||
1276|014|B|||
1276|015|U|USES:  Chenodiol is used to dissolve certain types of gallstones||
1276|016|U|(non-calcified). Chenodiol is a bile acid. Chenodiol may be tried||
1276|017|U|before surgery in patients that are at high risk of complications||
1276|018|U|from gallstone surgery. If the gallstones do not dissolve,||
1276|019|U|emergency surgery may still be needed.||
1276|020|B|||
1276|021|H|HOW TO USE:  Take this medication by mouth with or without food||
1276|022|H|as directed by your doctor, usually twice a day (once in the||
1276|023|H|morning and once at night).||
1276|024|H|   Dosage is based on your medical condition, weight, and||
1276|025|H|response to treatment.||
1276|026|H|   Aluminum-containing antacids and certain drugs to lower your||
1276|027|H|cholesterol (bile acid-binding resins such as cholestyramine or||
1276|028|H|colestipol) can decrease how much of this medication your body||
1276|029|H|absorbs. If you are taking any of these medications, separate||
1276|030|H|them from chenodiol by at least 4 hours.||
1276|031|H|   To reduce your risk of side effects such as diarrhea, your||
1276|032|H|doctor will direct you to start this medication at a low dose and||
1276|033|H|gradually increase your dose. Follow your doctor's instructions||
1276|034|H|carefully. Tell your doctor if you have severe diarrhea. Your||
1276|035|H|doctor may need to lower your dose or stop the medication.||
1276|036|H|   Do not increase your dose or take this medication more often||
1276|037|H|without your doctor's approval. Your condition will not improve||
1276|038|H|any faster, and the risk of serious side effects may be||
1276|039|H|increased.||
1276|040|H|   Use this medication regularly to get the most benefit from it.||
1276|041|H|To help you remember, take it at the same times each day. Do not||
1276|042|H|stop taking this medication without talking with your doctor.||
1276|043|H|   It may take up to 24 months before the gall stones are||
1276|044|H|completely dissolved. Your doctor will order tests (gall bladder||
1276|045|H|sonograms or x-rays) to check your progress. Keep all medical||
1276|046|H|appointments. Tell your doctor if your condition lasts or gets||
1276|047|H|worse (stomach/abdominal pain, nausea, or vomiting).||
1276|048|B|||
1276|049|S|SIDE EFFECTS:  Diarrhea, nausea, or heartburn may occur. If any||
1276|050|S|of these effects last or get worse, tell your doctor or||
1276|051|S|pharmacist promptly.||
1276|052|S|   Remember that this medication has been prescribed because your||
1276|053|S|doctor has judged that the benefit to you is greater than the||
1276|054|S|risk of side effects. Many people using this medication do not||
1276|055|S|have serious side effects.||
1276|056|S|   This drug may cause serious (possibly fatal) liver disease.||
1276|057|S|Your doctor will order blood tests to check for liver problems.||
1276|058|S|It is very important to keep all lab appointments. Get medical||
1276|059|S|help right away if you have any symptoms of liver damage,||
1276|060|S|including: nausea/vomiting that doesn't stop, yellowing||
1276|061|S|eyes/skin, dark urine, unusual tiredness, severe||
1276|062|S|stomach/abdominal pain.||
1276|063|S|   A very serious allergic reaction to this drug is rare.||
1276|064|S|However, get medical help right away if you notice any symptoms||
1276|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1276|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1276|067|S|breathing.||
1276|068|S|   This is not a complete list of possible side effects. If you||
1276|069|S|notice other effects not listed above, contact your doctor or||
1276|070|S|pharmacist.||
1276|071|S|   In the US -||
1276|072|S|   Call your doctor for medical advice about side effects. You||
1276|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1276|074|S|www.fda.gov/medwatch.||
1276|075|S|   In Canada - Call your doctor for medical advice about side||
1276|076|S|effects. You may report side effects to Health Canada at||
1276|077|S|1-866-234-2345.||
1276|078|B|||
1276|079|P|PRECAUTIONS:  Before taking chenodiol, tell your doctor or||
1276|080|P|pharmacist if you are allergic to it; or if you have any other||
1276|081|P|allergies. This product may contain inactive ingredients, which||
1276|082|P|can cause allergic reactions or other problems. Talk to your||
1276|083|P|pharmacist for more details.||
1276|084|P|   Before using this medication, tell your doctor or pharmacist||
1276|085|P|your medical history, especially of: liver problems (such as||
1276|086|P|hepatitis, cirrhosis), a certain red blood cell problem||
1276|087|P|(hemolysis), regular use/abuse of alcohol.||
1276|088|P|   Before having surgery, tell your doctor or dentist about all||
1276|089|P|the products you use (including prescription drugs,||
1276|090|P|nonprescription drugs, and herbal products).||
1276|091|P|   This medication must not be used during pregnancy. It may harm||
1276|092|P|an unborn baby. Estrogen-containing birth control may increase||
1276|093|P|your risk of gall stones. Discuss the use of reliable forms of||
1276|094|P|birth control with your doctor. If you become pregnant or think||
1276|095|P|you may be pregnant, tell your doctor right away.||
1276|096|P|   It is unknown if this drug passes into breast milk. Consult||
1276|097|P|your doctor before breastfeeding.||
1276|098|B|||
1276|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1276|100|I|medications work or increase your risk for serious side effects.||
1276|101|I|This document does not contain all possible drug interactions.||
1276|102|I|Keep a list of all the products you use (including||
1276|103|I|prescription/nonprescription drugs and herbal products) and share||
1276|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1276|105|I|the dosage of any medicines without your doctor's approval.||
1276|106|I|   Some products that may interact with this drug include:||
1276|107|I|estrogens (such as estradiol, estrogen pills/patch/cream, birth||
1276|108|I|control pills/patch/ring), "blood thinners" (such as warfarin).||
1276|109|B|||
1276|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1276|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1276|112|O|poison control center right away. US residents can call||
1276|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1276|114|B|||
1276|115|N|NOTES:  Do not share this medication with others.||
1276|116|N|   Lab and/or medical tests (such as liver function, cholesterol||
1276|117|N|tests) should be done while you are taking this medication. Keep||
1276|118|N|all medical and lab appointments. Consult your doctor for more||
1276|119|N|details.||
1276|120|N|   Maintaining a normal weight and a diet high in fiber (such as||
1276|121|N|bran) and low in cholesterol/carbohydrates may help prevent gall||
1276|122|N|stones. Ask your doctor, pharmacist, or nutritionist for more||
1276|123|N|information.||
1276|124|B|||
1276|125|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1276|126|D|remember. If it is near the time of the next dose, skip the||
1276|127|D|missed dose. Take your next dose at the regular time. Do not||
1276|128|D|double the dose to catch up.||
1276|129|B|||
1276|130|R|STORAGE:  Store at room temperature away from light and moisture.||
1276|131|R|Do not store in the bathroom. Keep all medications away from||
1276|132|R|children and pets.||
1276|133|R|   Do not flush medications down the toilet or pour them into a||
1276|134|R|drain unless instructed to do so. Properly discard this product||
1276|135|R|when it is expired or no longer needed. Consult your pharmacist||
1276|136|R|or local waste disposal company.||
1276|137|B|||
1276|138|A|Information last revised May 2024.||
1276|139|A|Copyright(c) 2025 First Databank, Inc.||
1276|140|B|||
1277|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1277|002|Z|does NOT have all possible information about this product. This||
1277|003|Z|information does not assure that this product is safe, effective,||
1277|004|Z|or appropriate for you. This information is not individual||
1277|005|Z|medical advice and does not substitute for the advice of your||
1277|006|Z|health care professional. Always ask your health care||
1277|007|Z|professional for complete information about this product and your||
1277|008|Z|specific health needs.||
1277|009|B|||
1277|010|T|SULFACETAMIDE SODIUM SHAMPOO - TOPICAL||
1277|011|F|(SUL-fa-SEET-a mide SOE dee um)||
1277|012|B|||
1277|013|C|COMMON BRAND NAME(S): Ovace Plus||
1277|014|B|||
1277|015|U|USES:  This medication is used to treat certain scalp conditions||
1277|016|U|(dandruff, seborrhea). These scalp problems can sometimes be||
1277|017|U|worsened by bacteria on the skin. This medication works by||
1277|018|U|stopping the growth of certain skin bacteria. Sodium||
1277|019|U|sulfacetamide belongs to a class of drugs known as sulfa||
1277|020|U|antibiotics.||
1277|021|U|   Do not use this medication in children under 2 months old.||
1277|022|B|||
1277|023|H|HOW TO USE:  This medication is for use on the hair and scalp||
1277|024|H|only. Shake the bottle well before using.||
1277|025|H|   Wet hair and scalp with water. Apply this product to wet hair||
1277|026|H|and massage it over your entire scalp until it forms a lather.||
1277|027|H|Rinse the medication off completely. Use this medication as||
1277|028|H|directed by your doctor, usually at least 2 times a week.||
1277|029|H|   Avoid getting this medication in the eyes, nose, or mouth. If||
1277|030|H|you do get medication into these areas, rinse with plenty of||
1277|031|H|water.||
1277|032|H|   How often you use this medication is based on your medical||
1277|033|H|condition and response to treatment.||
1277|034|H|   Use this medication regularly to get the most benefit from it.||
1277|035|H|Do not use large amounts of this medication, use it more often,||
1277|036|H|or use it for a longer time than prescribed. Your condition will||
1277|037|H|not improve any faster, and your risk of side effects may be||
1277|038|H|increased.||
1277|039|H|   Tell your doctor if your condition does not get better after a||
1277|040|H|few weeks or if it worsens.||
1277|041|B|||
1277|042|S|SIDE EFFECTS:  Although uncommon, irritation of the skin or scalp||
1277|043|S|may occur. If this effect lasts or gets worse, stop using this||
1277|044|S|medication and tell your doctor or pharmacist promptly.||
1277|045|S|   Remember that this medication has been prescribed because your||
1277|046|S|doctor has judged that the benefit to you is greater than the||
1277|047|S|risk of side effects. Many people using this medication do not||
1277|048|S|have serious side effects.||
1277|049|S|   Using this medication for prolonged periods may result in a||
1277|050|S|fungal skin infection. Contact your doctor if you notice new or||
1277|051|S|worsening skin/scalp symptoms.||
1277|052|S|   Rarely, sodium sulfacetamide products applied to the skin may||
1277|053|S|be absorbed and may cause serious side effects. Stop using this||
1277|054|S|product and tell your doctor right away if you have any serious||
1277|055|S|side effects, including: aching/swollen joints, rash on nose and||
1277|056|S|cheeks, signs of infection (such as sore throat that doesn't go||
1277|057|S|away, fever, chills), signs of anemia (such as unusual||
1277|058|S|tiredness/weakness, rapid breathing, fast heartbeat), unusual||
1277|059|S|bleeding/bruising, signs of liver problems (such as nausea that||
1277|060|S|doesn't stop, dark urine, yellowing eyes/skin, stomach/abdominal||
1277|061|S|pain, vomiting), mouth sores.||
1277|062|S|   A very serious allergic reaction to this drug is rare.||
1277|063|S|However, get medical help right away if you notice any symptoms||
1277|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1277|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1277|066|S|breathing.||
1277|067|S|   This is not a complete list of possible side effects. If you||
1277|068|S|notice other effects not listed above, contact your doctor or||
1277|069|S|pharmacist.||
1277|070|S|   In the US -||
1277|071|S|   Call your doctor for medical advice about side effects. You||
1277|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1277|073|S|www.fda.gov/medwatch.||
1277|074|S|   In Canada - Call your doctor for medical advice about side||
1277|075|S|effects. You may report side effects to Health Canada at||
1277|076|S|1-866-234-2345.||
1277|077|B|||
1277|078|P|PRECAUTIONS:  Before using sodium sulfacetamide shampoo, tell||
1277|079|P|your doctor or pharmacist if you are allergic to it; or to sulfa||
1277|080|P|antibiotics (such as sulfamethoxazole); or if you have any other||
1277|081|P|allergies. This product may contain inactive ingredients, which||
1277|082|P|can cause allergic reactions or other problems. Talk to your||
1277|083|P|pharmacist for more details.||
1277|084|P|   Before using this medication, tell your doctor or pharmacist||
1277|085|P|your medical history.||
1277|086|P|   Tell your doctor if there are areas of skin near where this||
1277|087|P|product will be applied that are cut, scraped, burned, or||
1277|088|P|infected. Injured skin may absorb more of this product, and the||
1277|089|P|chance of serious side effects may increase.||
1277|090|P|   Before having surgery, tell your doctor or dentist about all||
1277|091|P|the products you use (including prescription drugs,||
1277|092|P|nonprescription drugs, and herbal products).||
1277|093|P|   During pregnancy, this medication should be used only when||
1277|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
1277|095|P|   It is unknown if this drug passes into breast milk. Consult||
1277|096|P|your doctor before breastfeeding.||
1277|097|B|||
1277|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1277|099|I|medications work or increase your risk for serious side effects.||
1277|100|I|This document does not contain all possible drug interactions.||
1277|101|I|Keep a list of all the products you use (including||
1277|102|I|prescription/nonprescription drugs and herbal products) and share||
1277|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
1277|104|I|the dosage of any medicines without your doctor's approval.||
1277|105|I|   Some products that may interact with this drug include: skin||
1277|106|I|products containing silver.||
1277|107|B|||
1277|108|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1277|109|O|has overdosed and has serious symptoms such as passing out or||
1277|110|O|trouble breathing, call 911. Otherwise, call a poison control||
1277|111|O|center right away. US residents can call 1-800-222-1222. Canada||
1277|112|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1277|113|O|include: nausea, vomiting, pink/bloody urine, change in the||
1277|114|O|amount of urine.||
1277|115|B|||
1277|116|N|NOTES:  Do not share this medication with others.||
1277|117|N|   This product may temporarily stain clothing. The stain will||
1277|118|N|usually wash out with normal cleaning.||
1277|119|B|||
1277|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1277|121|D|If it is near the time of the next dose, skip the missed dose.||
1277|122|D|Use your next dose at the regular time. Do not double the dose to||
1277|123|D|catch up.||
1277|124|B|||
1277|125|R|STORAGE:  Store at room temperature. Avoid freezing and high||
1277|126|R|heat. This medication may darken slightly over time. This slight||
1277|127|R|darkening does not change the effectiveness or safety of the||
1277|128|R|medication. Keep all medications away from children and pets.||
1277|129|R|   Do not flush medications down the toilet or pour them into a||
1277|130|R|drain unless instructed to do so. Properly discard this product||
1277|131|R|when it is expired or no longer needed. Consult your pharmacist||
1277|132|R|or local waste disposal company.||
1277|133|B|||
1277|134|A|Information last revised April 2025.||
1277|135|A|Copyright(c) 2025 First Databank, Inc.||
1277|136|B|||
1278|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1278|002|Z|does NOT have all possible information about this product. This||
1278|003|Z|information does not assure that this product is safe, effective,||
1278|004|Z|or appropriate for you. This information is not individual||
1278|005|Z|medical advice and does not substitute for the advice of your||
1278|006|Z|health care professional. Always ask your health care||
1278|007|Z|professional for complete information about this product and your||
1278|008|Z|specific health needs.||
1278|009|B|||
1278|010|T|METHADONE CONCENTRATE - ORAL||
1278|011|F|(METH-uh-doan)||
1278|012|B|||
1278|013|C|COMMON BRAND NAME(S): Methadose||
1278|014|B|||
1278|015|W|WARNING:  Methadone has a risk for abuse and addiction, which can||
1278|016|W|lead to overdose and death. Methadone may also cause severe,||
1278|017|W|possibly fatal, breathing problems and heartbeat problems. To||
1278|018|W|lower your risk, your doctor should have you take the smallest||
1278|019|W|dose of methadone that works, and take it for the shortest||
1278|020|W|possible time. Do not increase your dose or take this medication||
1278|021|W|more often than directed. See also How to Use section for more||
1278|022|W|information about addiction.||
1278|023|W|   Ask your doctor or pharmacist if you should have medication||
1278|024|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1278|025|W|Teach your family or household members about the signs of an||
1278|026|W|opioid overdose and how to treat it.||
1278|027|W|   The risk for severe breathing problems or heartbeat problems||
1278|028|W|is higher when you start this medication, when you are switching||
1278|029|W|from another opioid to methadone, after a dose increase, or if||
1278|030|W|you take the wrong dose/strength. Breathing problems from||
1278|031|W|methadone may not happen right away after taking a dose. Most||
1278|032|W|heartbeat problems have happened in people using large doses of||
1278|033|W|methadone for pain relief, but this problem can also occur in||
1278|034|W|people taking smaller doses to treat opioid addiction. Taking||
1278|035|W|this medication with alcohol or other drugs that can cause||
1278|036|W|drowsiness or breathing problems may cause very serious side||
1278|037|W|effects, including death. Also, other medications can affect the||
1278|038|W|removal of methadone from your body, which may affect how||
1278|039|W|methadone works. Be sure you know how to take methadone and what||
1278|040|W|other drugs you should avoid taking with it. See also Drug||
1278|041|W|Interactions section. Get medical help right away if any of these||
1278|042|W|very serious side effects occur: slow/shallow breathing, unusual||
1278|043|W|lightheadedness, severe drowsiness/dizziness, difficulty waking||
1278|044|W|up, fast/irregular heartbeat, fainting.||
1278|045|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1278|046|W|or abuse. If someone accidentally swallows this drug, get medical||
1278|047|W|help right away.||
1278|048|W|   Before using this medication, women of childbearing age should||
1278|049|W|talk with their doctor(s) about the risks and benefits. Pregnancy||
1278|050|W|may affect the amount of this drug in your body, so tell your||
1278|051|W|doctor if you are pregnant or if you plan to become pregnant.||
1278|052|W|During pregnancy, this medication should be used only when||
1278|053|W|clearly needed. It may slightly increase the risk of birth||
1278|054|W|defects if used during the first two months of pregnancy. Also,||
1278|055|W|using it for a long time or in high doses near the expected||
1278|056|W|delivery date may harm the unborn baby. To lessen the risk, take||
1278|057|W|the smallest effective dose for the shortest possible time.||
1278|058|W|Babies born to mothers who use this drug for a long time may||
1278|059|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1278|060|W|doctor right away if you notice any symptoms in your newborn baby||
1278|061|W|such as crying that doesn't stop, slow/shallow breathing,||
1278|062|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1278|063|W|difficulty gaining weight.||
1278|064|B|||
1278|065|U|USES:  This medication is used to treat severe ongoing pain (such||
1278|066|U|as due to cancer). Methadone belongs to a class of drugs known as||
1278|067|U|opioid analgesics. It works in the brain to change how your body||
1278|068|U|feels and responds to pain.||
1278|069|U|   Do not use this medication to relieve pain that is mild or||
1278|070|U|that will go away in a few days (such as pain from surgery). This||
1278|071|U|medication is not for occasional ("as needed") use.||
1278|072|U|   This medication is also used to treat opioid use disorder as||
1278|073|U|part of an approved treatment program. It helps prevent||
1278|074|U|withdrawal symptoms caused by stopping other opioids.||
1278|075|B|||
1278|076|H|HOW TO USE:  See also Warning section.||
1278|077|H|   Some brands of this product come with a Medication Guide. If||
1278|078|H|available, read the Medication Guide provided by your pharmacist||
1278|079|H|before you start using methadone and each time you get a refill.||
1278|080|H|If you have any questions, ask your doctor or pharmacist.||
1278|081|H|   Take this medication by mouth on a regular schedule as||
1278|082|H|directed by your doctor, not as needed for sudden (breakthrough)||
1278|083|H|pain. You may take this drug with or without food. If you have||
1278|084|H|nausea, it may help to take this drug with food. Ask your doctor||
1278|085|H|or pharmacist about other ways to decrease nausea (such as lying||
1278|086|H|down for 1 to 2 hours with as little head movement as possible).||
1278|087|H|   Carefully measure the dose using a special measuring||
1278|088|H|device/spoon. Do not use a household spoon because you may not||
1278|089|H|get the correct dose. If your medication comes in an oral dosing||
1278|090|H|syringe, use the syringe to measure the dose. Do not inject the||
1278|091|H|medication. Before taking, mix the dose in at least 1 ounce (30||
1278|092|H|milliliters) of water or other liquid as directed. Drink all of||
1278|093|H|the mixture right away. Do not prepare a supply in advance.||
1278|094|H|   The dosage is based on your medical condition and response to||
1278|095|H|treatment.||
1278|096|H|   Suddenly stopping this medication may cause withdrawal,||
1278|097|H|especially if you have used it for a long time or in high doses.||
1278|098|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1278|099|H|Tell your doctor or pharmacist right away if you have any||
1278|100|H|withdrawal symptoms such as restlessness, mental/mood changes||
1278|101|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1278|102|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1278|103|H|aches, or sudden changes in behavior.||
1278|104|H|   When this medication is used for a long time, it may not work||
1278|105|H|as well. Talk with your doctor if this medication stops working||
1278|106|H|well.||
1278|107|H|   Though it helps many people, this medication may sometimes||
1278|108|H|cause addiction. This risk may be higher if you have a||
1278|109|H|mental/mood disorder or a substance use disorder (such as overuse||
1278|110|H|of or addiction to drugs/alcohol). Take this medication exactly||
1278|111|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1278|112|H|pharmacist for more details.||
1278|113|H|   Tell your doctor if your condition does not get better or if||
1278|114|H|it gets worse, or if you have any new pain.||
1278|115|B|||
1278|116|S|SIDE EFFECTS:  See also Warning section.||
1278|117|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
1278|118|S|dry mouth, drowsiness, or sweating may occur. Some of these side||
1278|119|S|effects may decrease after you have been using this medication||
1278|120|S|for a while. If any of these effects last or get worse, tell your||
1278|121|S|doctor or pharmacist promptly.||
1278|122|S|   To prevent constipation, eat dietary fiber, drink enough||
1278|123|S|water, and exercise. You may also need to take a laxative. Ask||
1278|124|S|your pharmacist which type of laxative is right for you.||
1278|125|S|   To reduce the risk of dizziness and lightheadedness, get up||
1278|126|S|slowly when rising from a sitting or lying position.||
1278|127|S|   Remember that this medication has been prescribed because your||
1278|128|S|doctor has judged that the benefit to you is greater than the||
1278|129|S|risk of side effects. Many people using this medication do not||
1278|130|S|have serious side effects.||
1278|131|S|   Tell your doctor right away if you have any serious side||
1278|132|S|effects, including: interrupted breathing during sleep (sleep||
1278|133|S|apnea), mental/mood changes (such as agitation, confusion,||
1278|134|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
1278|135|S|signs of your adrenal glands not working well (such as loss of||
1278|136|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
1278|137|S|   Get medical help right away if you have any very serious side||
1278|138|S|effects, including: seizure, severe drowsiness/difficulty waking||
1278|139|S|up.||
1278|140|S|   A very serious allergic reaction to this drug is rare.||
1278|141|S|However, get medical help right away if you notice any symptoms||
1278|142|S|of a serious allergic reaction, including: rash, itching/swelling||
1278|143|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1278|144|S|breathing.||
1278|145|S|   This is not a complete list of possible side effects. If you||
1278|146|S|notice other effects not listed above, contact your doctor or||
1278|147|S|pharmacist.||
1278|148|S|   In the US -||
1278|149|S|   Call your doctor for medical advice about side effects. You||
1278|150|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1278|151|S|www.fda.gov/medwatch.||
1278|152|S|   In Canada - Call your doctor for medical advice about side||
1278|153|S|effects. You may report side effects to Health Canada at||
1278|154|S|1-866-234-2345.||
1278|155|B|||
1278|156|P|PRECAUTIONS:  Before taking methadone, tell your doctor or||
1278|157|P|pharmacist if you are allergic to it; or if you have any other||
1278|158|P|allergies. This product may contain inactive ingredients, which||
1278|159|P|can cause allergic reactions or other problems. Talk to your||
1278|160|P|pharmacist for more details.||
1278|161|P|   Before using this medication, tell your doctor or pharmacist||
1278|162|P|your medical history, especially of: brain disorders (such as||
1278|163|P|head injury, tumor, seizures), breathing problems (such as||
1278|164|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1278|165|P|kidney disease, liver disease, mental/mood disorders (such as||
1278|166|P|confusion, depression, thoughts of suicide), personal or family||
1278|167|P|history of a substance use disorder (such as overuse of or||
1278|168|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
1278|169|P|blockage, constipation, diarrhea due to infection, paralytic||
1278|170|P|ileus), difficulty urinating (such as due to enlarged prostate),||
1278|171|P|disease of the pancreas (pancreatitis), gallbladder disease.||
1278|172|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1278|173|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1278|174|P|machinery, or do anything that needs alertness until you can do||
1278|175|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1278|176|P|are using marijuana (cannabis).||
1278|177|P|   Methadone may cause a condition that affects the heart rhythm||
1278|178|P|(QT prolongation). QT prolongation can rarely cause serious||
1278|179|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1278|180|P|as severe dizziness, fainting) that need medical attention right||
1278|181|P|away.||
1278|182|P|   The risk of QT prolongation may be increased if you have||
1278|183|P|certain medical conditions or are taking other drugs that may||
1278|184|P|cause QT prolongation. Before using methadone, tell your doctor||
1278|185|P|or pharmacist of all the drugs you take and if you have any of||
1278|186|P|the following conditions: certain heart problems (heart failure,||
1278|187|P|slow heartbeat, QT prolongation in the EKG), family history of||
1278|188|P|certain heart problems (QT prolongation in the EKG, sudden||
1278|189|P|cardiac death).||
1278|190|P|   Low levels of potassium or magnesium in the blood may also||
1278|191|P|increase your risk of QT prolongation. This risk may increase if||
1278|192|P|you use certain drugs (such as diuretics/"water pills") or if you||
1278|193|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1278|194|P|Talk to your doctor about using methadone safely.||
1278|195|P|   Some products may contain sugar. Caution is advised if you||
1278|196|P|have diabetes. Ask your doctor or pharmacist about using this||
1278|197|P|product safely.||
1278|198|P|   Before having surgery, tell your doctor or dentist about all||
1278|199|P|the products you use (including prescription drugs,||
1278|200|P|nonprescription drugs, and herbal products).||
1278|201|P|   Older adults may be more sensitive to the side effects of this||
1278|202|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
1278|203|P|breathing, and QT prolongation (see above).||
1278|204|P|   During pregnancy, this medication should be used only when||
1278|205|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1278|206|P|benefits with your doctor. (See also Warning section.)||
1278|207|P|   This drug passes into breast milk and may have undesirable||
1278|208|P|effects on a nursing infant. Tell the doctor right away if your||
1278|209|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1278|210|P|breathing. Consult your doctor before breastfeeding or if you||
1278|211|P|plan to stop breastfeeding.||
1278|212|B|||
1278|213|I|DRUG INTERACTIONS:  See also Warning section.||
1278|214|I|   Drug interactions may change how your medications work or||
1278|215|I|increase your risk for serious side effects. This document does||
1278|216|I|not contain all possible drug interactions. Keep a list of all||
1278|217|I|the products you use (including prescription/nonprescription||
1278|218|I|drugs and herbal products) and share it with your doctor and||
1278|219|I|pharmacist. Do not start, stop, or change the dosage of any||
1278|220|I|medicines without your doctor's approval.||
1278|221|I|   Some products that may interact with this drug include:||
1278|222|I|certain pain medications (mixed opioid agonist-antagonists such||
1278|223|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1278|224|I|samidorphan.||
1278|225|I|   Taking MAO inhibitors with this medication may cause a serious||
1278|226|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
1278|227|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1278|228|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1278|229|I|selegiline, tranylcypromine) during treatment with this||
1278|230|I|medication. Most MAO inhibitors should also not be taken for two||
1278|231|I|weeks before and after treatment with this medication. Ask your||
1278|232|I|doctor when to start or stop taking this medication.||
1278|233|I|   Other medications can affect the removal of methadone from||
1278|234|I|your body, which may affect how methadone works. Examples include||
1278|235|I|St. John's wort, azole antifungals (such as itraconazole),||
1278|236|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
1278|237|I|rifampin), drugs used to treat seizures (such as carbamazepine),||
1278|238|I|among others.||
1278|239|I|   The risk of serious side effects (such as slow/shallow||
1278|240|I|breathing, severe drowsiness/dizziness) may be increased if this||
1278|241|I|medication is taken with other products that may also cause||
1278|242|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1278|243|I|if you are taking other products such as other opioid pain or||
1278|244|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1278|245|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1278|246|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1278|247|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1278|248|I|cetirizine, diphenhydramine).||
1278|249|I|   Check the labels on all your medicines (such as allergy or||
1278|250|I|cough-and-cold products) because they may contain ingredients||
1278|251|I|that cause drowsiness. Ask your pharmacist about using those||
1278|252|I|products safely.||
1278|253|I|   This medication may interfere with certain lab tests (such as||
1278|254|I|amylase/lipase levels), possibly causing false test results. Make||
1278|255|I|sure lab personnel and all your doctors know you use this drug.||
1278|256|B|||
1278|257|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1278|258|O|as passing out or trouble breathing, give them naloxone or||
1278|259|O|nalmefene if available, then call 911. If the person is awake and||
1278|260|O|has no symptoms, call a poison control center right away. US||
1278|261|O|residents can call 1-800-222-1222. Canada residents can call||
1278|262|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1278|263|O|breathing, slow heartbeat, coma.||
1278|264|B|||
1278|265|N|NOTES:  Do not share this medication with others. Sharing it is||
1278|266|N|against the law.||
1278|267|N|   This medication has been prescribed for your current condition||
1278|268|N|only. Do not use it later for another condition unless told to do||
1278|269|N|so by your doctor. A different medication may be necessary in||
1278|270|N|those cases.||
1278|271|B|||
1278|272|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1278|273|D|remember. If it is near the time of the next dose, skip the||
1278|274|D|missed dose. Take your next dose at the regular time. Do not||
1278|275|D|double the dose to catch up.||
1278|276|B|||
1278|277|R|STORAGE:  Store at room temperature away from light and moisture.||
1278|278|R|Do not store in the bathroom. Keep all medications away from||
1278|279|R|children and pets. See also Warning section.||
1278|280|R|   Do not flush medications down the toilet or pour them into a||
1278|281|R|drain unless instructed to do so. Properly discard this product||
1278|282|R|when it is expired or no longer needed. For more details, read||
1278|283|R|the Medication Guide, or consult your pharmacist or local waste||
1278|284|R|disposal company.||
1278|285|B|||
1278|286|A|Information last revised August 2025.||
1278|287|A|Copyright(c) 2025 First Databank, Inc.||
1278|288|B|||
1279|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1279|002|Z|does NOT have all possible information about this product. This||
1279|003|Z|information does not assure that this product is safe, effective,||
1279|004|Z|or appropriate for you. This information is not individual||
1279|005|Z|medical advice and does not substitute for the advice of your||
1279|006|Z|health care professional. Always ask your health care||
1279|007|Z|professional for complete information about this product and your||
1279|008|Z|specific health needs.||
1279|009|B|||
1279|010|T|RIBAVIRIN TABLET - ORAL||
1279|011|F|(rye-buh-VYE-rin)||
1279|012|B|||
1279|013|C|COMMON BRAND NAME(S): Copegus, Ribapak||
1279|014|B|||
1279|015|W|WARNING:  Ribavirin may cause birth defects and/or death in||
1279|016|W|unborn babies that are exposed to it during pregnancy. If you or||
1279|017|W|your sexual partner are or may be pregnant, do not take||
1279|018|W|ribavirin, and contact your doctor right away. Women using this||
1279|019|W|medication must avoid pregnancy by using reliable forms of birth||
1279|020|W|control during treatment and for 9 months after this medication||
1279|021|W|is stopped. Men using this medication must avoid causing||
1279|022|W|pregnancy by using reliable forms of birth control during||
1279|023|W|treatment and for 6 months after this medication is stopped.||
1279|024|W|Consult your doctor or pharmacist for more information.||
1279|025|W|   Patients with certain types of heart disease should not use||
1279|026|W|ribavirin because it can lower your red blood cell level||
1279|027|W|(anemia). This may worsen your condition and can lead to a||
1279|028|W|possibly fatal heart attack. Before using this medication, tell||
1279|029|W|your doctor if you have had any heart problems or chest pain.||
1279|030|W|   Ribavirin should never be used alone to treat hepatitis C||
1279|031|W|infections.||
1279|032|B|||
1279|033|U|USES:  Ribavirin is used in combination with other antiviral||
1279|034|U|medications (such as interferon, sofosbuvir) to treat chronic||
1279|035|U|(long-lasting) hepatitis C, a viral infection of the liver.||
1279|036|U|Chronic hepatitis C infection can cause serious liver problems||
1279|037|U|such as scarring (cirrhosis), or liver cancer. Ribavirin works by||
1279|038|U|reducing the amount of hepatitis C virus in your body, which may||
1279|039|U|help your liver recover.||
1279|040|U|   It is not known if this treatment can prevent you from passing||
1279|041|U|the virus to others. Do not share needles, and practice "safer||
1279|042|U|sex" (including the use of latex condoms) to lower the risk of||
1279|043|U|passing the virus to others.||
1279|044|B|||
1279|045|V|OTHER USES:  This section contains uses of this drug that are not||
1279|046|V|listed in the approved professional labeling for the drug but||
1279|047|V|that may be prescribed by your health care professional. Use this||
1279|048|V|drug for a condition that is listed in this section only if it||
1279|049|V|has been so prescribed by your health care professional.||
1279|050|V|   This drug may also be used for severe acute respiratory||
1279|051|V|syndrome (SARS).||
1279|052|B|||
1279|053|H|HOW TO USE:  Read the Medication Guide provided by your||
1279|054|H|pharmacist before you start taking ribavirin and each time you||
1279|055|H|get a refill. If you have any questions, ask your doctor or||
1279|056|H|pharmacist. Also read the drug information for your other||
1279|057|H|antiviral medication(s).||
1279|058|H|   Take this medication by mouth as directed by your doctor,||
1279|059|H|usually twice daily with food.||
1279|060|H|   The dosage and length of treatment is based on your age,||
1279|061|H|weight, medical condition, and response to treatment.||
1279|062|H|   If this medication comes in a dosing package, carefully follow||
1279|063|H|the directions on the dosing package unless your doctor directs||
1279|064|H|you otherwise.||
1279|065|H|   This medication works best when the amount of drug in your||
1279|066|H|body is kept at a constant level. Take this drug at evenly spaced||
1279|067|H|intervals. To help you remember, take it at the same times each||
1279|068|H|day.||
1279|069|H|   Continue to take ribavirin and your other antiviral||
1279|070|H|medication(s) for the full length of time prescribed, even if||
1279|071|H|your symptoms disappear after a short time. Stopping any of the||
1279|072|H|drugs too early may result in a return of the infection.||
1279|073|H|   Drink plenty of water while being treated with this||
1279|074|H|medication. Doing so will decrease the risk of serious side||
1279|075|H|effects.||
1279|076|H|   Since this drug can be absorbed through the skin and lungs and||
1279|077|H|may harm an unborn baby, women who are pregnant or who may become||
1279|078|H|pregnant should not handle this medication or breathe the dust||
1279|079|H|from the tablets.||
1279|080|B|||
1279|081|S|SIDE EFFECTS:  Nausea, diarrhea, stomach upset, headache,||
1279|082|S|dizziness, blurred vision, trouble sleeping, cough, low appetite,||
1279|083|S|weight loss or gain, dry skin, or changes in taste/hearing may||
1279|084|S|occur. If any of these effects last or get worse, tell your||
1279|085|S|doctor or pharmacist promptly.||
1279|086|S|   Remember that this medication has been prescribed because your||
1279|087|S|doctor has judged that the benefit to you is greater than the||
1279|088|S|risk of side effects. Many people using this medication do not||
1279|089|S|have serious side effects.||
1279|090|S|   Tell your doctor right away if you have any serious side||
1279|091|S|effects, including: unusual tiredness/weakness,||
1279|092|S|fast/pounding/irregular heartbeat, muscle/joint pain, vision||
1279|093|S|changes, easy bruising/bleeding, dark urine, yellowing of||
1279|094|S|eyes/skin.||
1279|095|S|   Get medical help right away if you have any very serious side||
1279|096|S|effects, including: chest pain, jaw/left arm pain, stomach/lower||
1279|097|S|back pain, black/bloody stools.||
1279|098|S|   A very serious allergic reaction to this drug is rare.||
1279|099|S|However, get medical help right away if you notice any symptoms||
1279|100|S|of a serious allergic reaction, including: rash, itching/swelling||
1279|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1279|102|S|breathing.||
1279|103|S|   This is not a complete list of possible side effects. If you||
1279|104|S|notice other effects not listed above, contact your doctor or||
1279|105|S|pharmacist.||
1279|106|S|   In the US -||
1279|107|S|   Call your doctor for medical advice about side effects. You||
1279|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1279|109|S|www.fda.gov/medwatch.||
1279|110|S|   In Canada - Call your doctor for medical advice about side||
1279|111|S|effects. You may report side effects to Health Canada at||
1279|112|S|1-866-234-2345.||
1279|113|B|||
1279|114|P|PRECAUTIONS:  Before taking ribavirin, tell your doctor or||
1279|115|P|pharmacist if you are allergic to it; or if you have any other||
1279|116|P|allergies. This product may contain inactive ingredients, which||
1279|117|P|can cause allergic reactions or other problems. Talk to your||
1279|118|P|pharmacist for more details.||
1279|119|P|   Before using this medication, tell your doctor or pharmacist||
1279|120|P|your medical history, especially of: blood disorders (such as||
1279|121|P|sickle cell anemia, low hemoglobin, thalassemia), kidney disease,||
1279|122|P|other liver problems (such as autoimmune hepatitis), heart||
1279|123|P|disease, high blood pressure, breathing problems, pancreas||
1279|124|P|problems (such as pancreatitis), diabetes.||
1279|125|P|   This drug may make you dizzy or unusually tired or blur your||
1279|126|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
1279|127|P|or tired. Do not drive, use machinery, or do anything that needs||
1279|128|P|alertness or clear vision until you can do it safely. Avoid||
1279|129|P|alcoholic beverages. Talk to your doctor if you are using||
1279|130|P|marijuana (cannabis).||
1279|131|P|   Older adults may be at greater risk for anemia while using||
1279|132|P|this drug.||
1279|133|P|   Ribavirin must not be used during pregnancy. It is recommended||
1279|134|P|that female patients or female partners of male patients take a||
1279|135|P|pregnancy test before this medication is started. Pregnancy tests||
1279|136|P|should continue to be done while using this medication and for||
1279|137|P|some time after this medication is stopped (for 9 months for||
1279|138|P|female patients and for 6 months for female partners of male||
1279|139|P|patients). If you or your partner become pregnant, or if you||
1279|140|P|think you or your partner may be pregnant, tell your doctor right||
1279|141|P|away. See also Warning section.||
1279|142|P|   Since this drug can be absorbed through the skin and lungs and||
1279|143|P|may harm an unborn baby, women who are pregnant or who may become||
1279|144|P|pregnant should not handle this medication or breathe the dust||
1279|145|P|from the tablets.||
1279|146|P|   It is unknown if this drug passes into breast milk. Consult||
1279|147|P|your doctor before breastfeeding.||
1279|148|B|||
1279|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1279|150|I|medications work or increase your risk for serious side effects.||
1279|151|I|This document does not contain all possible drug interactions.||
1279|152|I|Keep a list of all the products you use (including||
1279|153|I|prescription/nonprescription drugs and herbal products) and share||
1279|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
1279|155|I|the dosage of any medicines without your doctor's approval.||
1279|156|I|   Some products that may interact with this drug include:||
1279|157|I|antacids, didanosine, zidovudine.||
1279|158|B|||
1279|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1279|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1279|161|O|poison control center right away. US residents can call||
1279|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1279|163|B|||
1279|164|N|NOTES:  Do not share this medication with others.||
1279|165|N|   Lab and/or medical tests (such as pregnancy, blood||
1279|166|N|counts/hemoglobin, liver/thyroid/heart function, EKG, eye exams)||
1279|167|N|should be done while you are taking this medication. Keep all||
1279|168|N|medical and lab appointments. Consult your doctor for more||
1279|169|N|details.||
1279|170|N|   This medication has been prescribed for your current condition||
1279|171|N|only. Do not use it later for another infection unless your||
1279|172|N|doctor tells you to.||
1279|173|B|||
1279|174|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1279|175|D|If it is near the time of the next dose, skip the missed dose.||
1279|176|D|Use your next dose at the regular time. Do not double the dose to||
1279|177|D|catch up.||
1279|178|B|||
1279|179|R|STORAGE:  Store at room temperature away from light and moisture.||
1279|180|R|Do not store in the bathroom. Keep all medications away from||
1279|181|R|children and pets.||
1279|182|R|   Do not flush medications down the toilet or pour them into a||
1279|183|R|drain unless instructed to do so. Properly discard this product||
1279|184|R|when it is expired or no longer needed. Consult your pharmacist||
1279|185|R|or local waste disposal company.||
1279|186|B|||
1279|187|A|Information last revised May 2024.||
1279|188|A|Copyright(c) 2025 First Databank, Inc.||
1279|189|B|||
1280|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1280|002|Z|does NOT have all possible information about this product. This||
1280|003|Z|information does not assure that this product is safe, effective,||
1280|004|Z|or appropriate for you. This information is not individual||
1280|005|Z|medical advice and does not substitute for the advice of your||
1280|006|Z|health care professional. Always ask your health care||
1280|007|Z|professional for complete information about this product and your||
1280|008|Z|specific health needs.||
1280|009|B|||
1280|010|T|ILOPERIDONE - ORAL||
1280|011|F|(EYE-loe-PER-i-done)||
1280|012|B|||
1280|013|C|COMMON BRAND NAME(S): Fanapt||
1280|014|B|||
1280|015|W|WARNING:  There may be a slightly increased risk of serious,||
1280|016|W|possibly fatal side effects (such as stroke, heart failure,||
1280|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1280|018|W|by older adults with dementia. This medication is not approved||
1280|019|W|for the treatment of dementia-related behavior problems. Discuss||
1280|020|W|the risks and benefits of this medication, as well as other||
1280|021|W|effective and possibly safer treatments for dementia-related||
1280|022|W|behavior problems, with the doctor.||
1280|023|W|   If you are using iloperidone in combination with other||
1280|024|W|medication to treat depression, also carefully read the drug||
1280|025|W|information for the other medication.||
1280|026|B|||
1280|027|U|USES:  This medication is used to treat certain mental/mood||
1280|028|U|disorders (such as schizophrenia, bipolar disorder). Iloperidone||
1280|029|U|belongs to a class of drugs known as atypical antipsychotics. It||
1280|030|U|works by helping to restore the balance of certain natural||
1280|031|U|substances in the brain.||
1280|032|B|||
1280|033|V|OTHER USES:  This section contains uses of this drug that are not||
1280|034|V|listed in the approved professional labeling for the drug but||
1280|035|V|that may be prescribed by your health care professional. Use this||
1280|036|V|drug for a condition that is listed in this section only if it||
1280|037|V|has been so prescribed by your health care professional.||
1280|038|V|   This drug may also be used in combination with other||
1280|039|V|medication for depression.||
1280|040|B|||
1280|041|H|HOW TO USE:  Take this medication by mouth with or without food||
1280|042|H|as directed by your doctor, usually 2 times a day. The dosage is||
1280|043|H|based on your medical condition, your response to treatment, and||
1280|044|H|other medications you may be taking. Be sure to tell your doctor||
1280|045|H|and pharmacist about all the products you use (including||
1280|046|H|prescription drugs, nonprescription drugs, and herbal products).||
1280|047|H|   To reduce your risk of side effects from low blood pressure||
1280|048|H|(such as dizziness, fainting, fast heartbeat), your doctor will||
1280|049|H|start you on a low dose and gradually increase your dose until||
1280|050|H|you are taking the best dose for you. It may take 1 to 2 weeks||
1280|051|H|before you are taking your full dose. Follow your doctor's||
1280|052|H|directions carefully.||
1280|053|H|   Take this medication regularly to get the most benefit from||
1280|054|H|it. To help you remember, take it at the same times each day. If||
1280|055|H|you miss or stop taking this medication for more than 3 days, do||
1280|056|H|not restart taking this medication at the same dose without||
1280|057|H|calling your doctor first. Your doctor may direct you to restart||
1280|058|H|at a low dose and gradually increase the dose.||
1280|059|H|   Keep taking this medication exactly as prescribed, even if you||
1280|060|H|are feeling better and thinking more clearly. Do not increase||
1280|061|H|your dose or take this drug more often than prescribed. Your||
1280|062|H|symptoms will not improve any faster, and your risk of side||
1280|063|H|effects will increase. Do not stop taking this medication without||
1280|064|H|consulting your doctor.||
1280|065|H|   Tell your doctor if your condition does not get better or if||
1280|066|H|it gets worse. It may take several weeks before you feel the full||
1280|067|H|benefit of this medication.||
1280|068|B|||
1280|069|S|SIDE EFFECTS:  See also How to Use section.||
1280|070|S|   Drowsiness, dizziness, lightheadedness, dry mouth, tiredness,||
1280|071|S|stuffy nose, and weight gain may occur. If any of these effects||
1280|072|S|last or get worse, tell your doctor or pharmacist promptly.||
1280|073|S|   This medication may cause a serious drop in blood pressure,||
1280|074|S|especially when starting or increasing the dose. Dizziness and||
1280|075|S|lightheadedness can increase the risk of falling. Get up slowly||
1280|076|S|when rising from a sitting or lying position.||
1280|077|S|   Remember that this medication has been prescribed because your||
1280|078|S|doctor has judged that the benefit to you is greater than the||
1280|079|S|risk of side effects. Many people using this medication do not||
1280|080|S|have serious side effects.||
1280|081|S|   Tell your doctor right away if you have any serious side||
1280|082|S|effects, including: drooling/trouble swallowing, signs of||
1280|083|S|infection (such as sore throat that doesn't go away, fever,||
1280|084|S|chills), shaking (tremor), muscle spasms, interrupted breathing||
1280|085|S|during sleep.||
1280|086|S|   Rarely, this medication may cause face/muscle twitching and||
1280|087|S|uncontrollable movements (tardive dyskinesia). In some cases,||
1280|088|S|this condition may be permanent. Tell your doctor right away if||
1280|089|S|you develop any uncontrollable movements such as lip smacking,||
1280|090|S|mouth puckering, tongue thrusting, chewing, or unusual arm/leg||
1280|091|S|movements.||
1280|092|S|   This drug may rarely make your blood sugar rise, which can||
1280|093|S|cause or worsen diabetes. Weight gain from this drug may increase||
1280|094|S|the risk of this side effect. Tell your doctor right away if you||
1280|095|S|have symptoms of high blood sugar such as increased||
1280|096|S|thirst/urination. If you already have diabetes, check your blood||
1280|097|S|sugar regularly as directed and share the results with your||
1280|098|S|doctor. Your doctor may need to adjust your diabetes medication,||
1280|099|S|exercise program, or diet.||
1280|100|S|   In rare cases, iloperidone may increase your level of a||
1280|101|S|certain substance made by the body (prolactin). For females, this||
1280|102|S|increase in prolactin may result in unwanted breast milk,||
1280|103|S|missed/stopped periods, or difficulty becoming pregnant. For||
1280|104|S|males, it may result in decreased sexual ability, inability to||
1280|105|S|produce sperm, or enlarged breasts. If you develop any of these||
1280|106|S|symptoms, tell your doctor right away.||
1280|107|S|   Rarely, males may have a painful or prolonged erection lasting||
1280|108|S|4 or more hours. If this occurs, stop using this drug and get||
1280|109|S|medical help right away, or permanent problems could occur.||
1280|110|S|   Get medical help right away if you have any very serious side||
1280|111|S|effects, including: fainting, fast/irregular heartbeat, seizures,||
1280|112|S|severe dizziness, chest pain.||
1280|113|S|   This medication may rarely cause a very serious condition||
1280|114|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1280|115|S|right away if you have any of the following symptoms: fever,||
1280|116|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1280|117|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1280|118|S|signs of kidney problems (such as change in the amount of urine).||
1280|119|S|   A very serious allergic reaction to this drug is rare.||
1280|120|S|However, get medical help right away if you notice any symptoms||
1280|121|S|of a serious allergic reaction, including: rash, itching/swelling||
1280|122|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1280|123|S|breathing.||
1280|124|S|   This is not a complete list of possible side effects. If you||
1280|125|S|notice other effects not listed above, contact your doctor or||
1280|126|S|pharmacist.||
1280|127|S|   In the US -||
1280|128|S|   Call your doctor for medical advice about side effects. You||
1280|129|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1280|130|S|www.fda.gov/medwatch.||
1280|131|S|   In Canada - Call your doctor for medical advice about side||
1280|132|S|effects. You may report side effects to Health Canada at||
1280|133|S|1-866-234-2345.||
1280|134|B|||
1280|135|P|PRECAUTIONS:  See also Warning section.||
1280|136|P|   Before taking iloperidone, tell your doctor or pharmacist if||
1280|137|P|you are allergic to it; or if you have any other allergies. This||
1280|138|P|product may contain inactive ingredients, which can cause||
1280|139|P|allergic reactions or other problems. Talk to your pharmacist for||
1280|140|P|more details.||
1280|141|P|   Before using this medication, tell your doctor or pharmacist||
1280|142|P|your medical history, especially of: liver problems, heart||
1280|143|P|problems (such as past heart attack, chest pain, abnormal||
1280|144|P|heartbeat), stroke, diabetes (including family history), obesity,||
1280|145|P|low blood pressure, seizures, low white blood cell count,||
1280|146|P|dehydration, breast cancer, dementia (such as Alzheimer's||
1280|147|P|Disease), trouble swallowing, breathing trouble during sleep||
1280|148|P|(sleep apnea), certain eye problems (cataracts, glaucoma).||
1280|149|P|   Iloperidone may cause a condition that affects the heart||
1280|150|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1280|151|P|serious (rarely fatal) fast/irregular heartbeat and other||
1280|152|P|symptoms (such as severe dizziness, fainting) that need medical||
1280|153|P|attention right away.||
1280|154|P|   The risk of QT prolongation may be increased if you have||
1280|155|P|certain medical conditions or are taking other drugs that may||
1280|156|P|cause QT prolongation. Before using iloperidone, tell your doctor||
1280|157|P|or pharmacist of all the drugs you take and if you have any of||
1280|158|P|the following conditions: certain heart problems (heart failure,||
1280|159|P|slow heartbeat, QT prolongation in the EKG), family history of||
1280|160|P|certain heart problems (QT prolongation in the EKG, sudden||
1280|161|P|cardiac death).||
1280|162|P|   Low levels of potassium or magnesium in the blood may also||
1280|163|P|increase your risk of QT prolongation. This risk may increase if||
1280|164|P|you use certain drugs (such as diuretics/"water pills") or if you||
1280|165|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1280|166|P|Talk to your doctor about using iloperidone safely.||
1280|167|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1280|168|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1280|169|P|machinery, or do anything that needs alertness until you can do||
1280|170|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1280|171|P|are using marijuana (cannabis).||
1280|172|P|   Before having surgery (including cataract/glaucoma eye||
1280|173|P|surgery), tell your doctor or dentist if you are taking or have||
1280|174|P|ever taken this medication, and about all the other products you||
1280|175|P|use (including prescription drugs, nonprescription drugs, and||
1280|176|P|herbal products).||
1280|177|P|   This medication may make you sweat less, making you more||
1280|178|P|likely to get heat stroke. Avoid doing things that may cause you||
1280|179|P|to overheat, such as hard work or exercise in hot weather, or||
1280|180|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1280|181|P|and dress lightly. If you overheat, quickly look for a place to||
1280|182|P|cool down and rest. Get medical help right away if you have a||
1280|183|P|fever that does not go away, mental/mood changes, headache, or||
1280|184|P|dizziness.||
1280|185|P|   Older adults may be more sensitive to the side effects of this||
1280|186|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
1280|187|P|prolongation (see above). Drowsiness, dizziness, and||
1280|188|P|lightheadedness can increase the risk of falling.||
1280|189|P|   During pregnancy, this medication should be used only when||
1280|190|P|clearly needed. Babies born to mothers who have used this drug||
1280|191|P|during the last 3 months of pregnancy may rarely develop symptoms||
1280|192|P|including muscle stiffness or shakiness, drowsiness,||
1280|193|P|feeding/breathing difficulties, or constant crying. If you notice||
1280|194|P|any of these symptoms in your newborn especially during their||
1280|195|P|first month, tell the doctor right away.||
1280|196|P|   Since untreated mental/mood problems (such as schizophrenia,||
1280|197|P|depression) can be a serious condition, do not stop taking this||
1280|198|P|medication unless directed by your doctor. If you are planning||
1280|199|P|pregnancy, become pregnant, or think you may be pregnant,||
1280|200|P|immediately discuss with your doctor the benefits and risks of||
1280|201|P|using this medication during pregnancy.||
1280|202|P|   It is unknown if this medication passes into breast milk.||
1280|203|P|Because of the possible risk to the infant, breastfeeding is not||
1280|204|P|recommended while using this medication. Consult your doctor||
1280|205|P|before breastfeeding.||
1280|206|B|||
1280|207|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1280|208|I|medications work or increase your risk for serious side effects.||
1280|209|I|This document does not contain all possible drug interactions.||
1280|210|I|Keep a list of all the products you use (such as||
1280|211|I|prescription/nonprescription drugs and herbal products) and share||
1280|212|I|it with your doctor and pharmacist. Do not start, stop, or change||
1280|213|I|the dosage of any medicines without your doctor's approval.||
1280|214|I|   Some products that may interact with this drug are: alpha||
1280|215|I|blockers (such as prazosin).||
1280|216|I|   Other medications can affect the removal of iloperidone from||
1280|217|I|your body, which may affect how iloperidone works. Examples||
1280|218|I|include antidepressants (such as nefazodone), among others.||
1280|219|I|   Many drugs besides iloperidone may affect the heart rhythm (QT||
1280|220|I|prolongation), such as amiodarone, dofetilide, pimozide,||
1280|221|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
1280|222|I|erythromycin), among others.||
1280|223|I|   Tell your doctor or pharmacist if you are taking other||
1280|224|I|products that cause drowsiness such as opioid pain or cough||
1280|225|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1280|226|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1280|227|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1280|228|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1280|229|I|diphenhydramine).||
1280|230|I|   Check the labels on all your medicines (such as allergy or||
1280|231|I|cough-and-cold products) because they may contain ingredients||
1280|232|I|that cause drowsiness. Ask your pharmacist about using those||
1280|233|I|products safely.||
1280|234|B|||
1280|235|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1280|236|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1280|237|O|poison control center right away. US residents can call||
1280|238|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1280|239|B|||
1280|240|N|NOTES:  Do not share this medication with others.||
1280|241|N|   Lab and/or medical tests (such as EKG, blood sugar,||
1280|242|N|potassium/magnesium blood levels, blood pressure, weight, blood||
1280|243|N|cholesterol/triglyceride levels) should be done while you are||
1280|244|N|taking this medication. Keep all medical and lab appointments.||
1280|245|N|Consult your doctor for more details.||
1280|246|B|||
1280|247|D|MISSED DOSE:  See also How to Use section.||
1280|248|D|   If you miss a dose, take it as soon as you remember. If it is||
1280|249|D|near the time of the next dose, skip the missed dose. Take your||
1280|250|D|next dose at the regular time. Do not double the dose to catch||
1280|251|D|up.||
1280|252|B|||
1280|253|R|STORAGE:  Store at room temperature away from light and moisture.||
1280|254|R|Do not store in the bathroom. Keep all medications away from||
1280|255|R|children and pets.||
1280|256|R|   Do not flush medications down the toilet or pour them into a||
1280|257|R|drain unless instructed to do so. Properly discard this product||
1280|258|R|when it is expired or no longer needed. Consult your pharmacist||
1280|259|R|or local waste disposal company.||
1280|260|B|||
1280|261|A|Information last revised April 2025.||
1280|262|A|Copyright(c) 2025 First Databank, Inc.||
1280|263|B|||
1281|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1281|002|Z|does NOT have all possible information about this product. This||
1281|003|Z|information does not assure that this product is safe, effective,||
1281|004|Z|or appropriate for you. This information is not individual||
1281|005|Z|medical advice and does not substitute for the advice of your||
1281|006|Z|health care professional. Always ask your health care||
1281|007|Z|professional for complete information about this product and your||
1281|008|Z|specific health needs.||
1281|009|B|||
1281|010|T|FOSINOPRIL - ORAL||
1281|011|F|(fos-IN-oh-pril)||
1281|012|B|||
1281|013|C|COMMON BRAND NAME(S): Monopril||
1281|014|B|||
1281|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
1281|016|W|unborn baby if used during pregnancy. It is important to prevent||
1281|017|W|pregnancy while taking this medication. Consult your doctor for||
1281|018|W|more details and to discuss the use of reliable forms of birth||
1281|019|W|control while taking this medication. If you are planning||
1281|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
1281|021|W|your doctor right away.||
1281|022|B|||
1281|023|U|USES:  Fosinopril is used to treat high blood pressure||
1281|024|U|(hypertension). Lowering high blood pressure helps prevent||
1281|025|U|strokes, heart attacks, and kidney problems. It is also used to||
1281|026|U|treat heart failure.||
1281|027|U|   Fosinopril is an ACE inhibitor and works by relaxing blood||
1281|028|U|vessels so that blood can flow more easily.||
1281|029|B|||
1281|030|V|OTHER USES:  This section contains uses of this drug that are not||
1281|031|V|listed in the approved professional labeling for the drug but||
1281|032|V|that may be prescribed by your health care professional. Use this||
1281|033|V|drug for a condition that is listed in this section only if it||
1281|034|V|has been so prescribed by your health care professional.||
1281|035|V|   This medication may also be used for kidney disease and to||
1281|036|V|help protect the kidneys from harm due to diabetes.||
1281|037|B|||
1281|038|H|HOW TO USE:  Take this medication by mouth with or without food||
1281|039|H|as directed by your doctor, usually once or twice daily.||
1281|040|H|   The dosage is based on your medical condition and response to||
1281|041|H|treatment.||
1281|042|H|   Antacids containing aluminum or magnesium can decrease the||
1281|043|H|absorption of fosinopril. If you are taking an antacid that||
1281|044|H|contains aluminum or magnesium, take it at least 2 hours before||
1281|045|H|or 2 hours after taking this product.||
1281|046|H|   Use this medication regularly in order to get the most benefit||
1281|047|H|from it. To help you remember, take it at the same time(s) each||
1281|048|H|day. Keep taking this medication even if you feel well. Most||
1281|049|H|people with high blood pressure do not feel sick.||
1281|050|H|   For the treatment of high blood pressure, it may take several||
1281|051|H|weeks before you get the full benefit of this medication. For the||
1281|052|H|treatment of heart failure, it may take weeks to months before||
1281|053|H|you get the full benefit of this medication. Tell your doctor if||
1281|054|H|your condition does not get better or if it gets worse (for||
1281|055|H|example, your blood pressure readings remain high or increase).||
1281|056|B|||
1281|057|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
1281|058|S|body adjusts to the medication. Dry cough may also occur. If any||
1281|059|S|of these effects last or get worse, tell your doctor or||
1281|060|S|pharmacist promptly.||
1281|061|S|   To reduce the risk of dizziness and lightheadedness, get up||
1281|062|S|slowly when rising from a sitting or lying position.||
1281|063|S|   Remember that this medication has been prescribed because your||
1281|064|S|doctor has judged that the benefit to you is greater than the||
1281|065|S|risk of side effects. Many people using this medication do not||
1281|066|S|have serious side effects.||
1281|067|S|   Tell your doctor right away if you have any serious side||
1281|068|S|effects, including: fainting, symptoms of a high potassium blood||
1281|069|S|level (such as muscle weakness, slow/irregular heartbeat).||
1281|070|S|   Although fosinopril may be used to prevent kidney problems or||
1281|071|S|treat people who have kidney problems, it may also rarely cause||
1281|072|S|serious kidney problems or make them worse. Your doctor will||
1281|073|S|check your kidney function while you are taking fosinopril. Tell||
1281|074|S|your doctor right away if you have any signs of kidney problems||
1281|075|S|such as a change in the amount of urine.||
1281|076|S|   This drug may rarely cause serious (possibly fatal) liver||
1281|077|S|problems. Get medical help right away if you have any symptoms of||
1281|078|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1281|079|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1281|080|S|urine.||
1281|081|S|   A very serious allergic reaction to this drug is rare.||
1281|082|S|However, get medical help right away if you notice any symptoms||
1281|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1281|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1281|085|S|breathing.||
1281|086|S|   This is not a complete list of possible side effects. If you||
1281|087|S|notice other effects not listed above, contact your doctor or||
1281|088|S|pharmacist.||
1281|089|S|   In the US -||
1281|090|S|   Call your doctor for medical advice about side effects. You||
1281|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1281|092|S|www.fda.gov/medwatch.||
1281|093|S|   In Canada - Call your doctor for medical advice about side||
1281|094|S|effects. You may report side effects to Health Canada at||
1281|095|S|1-866-234-2345.||
1281|096|B|||
1281|097|P|PRECAUTIONS:  Before taking fosinopril, tell your doctor or||
1281|098|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
1281|099|P|(such as benazepril); or if you have any other allergies. This||
1281|100|P|product may contain inactive ingredients, which can cause||
1281|101|P|allergic reactions or other problems. Talk to your pharmacist for||
1281|102|P|more details.||
1281|103|P|   Before using this medication, tell your doctor or pharmacist||
1281|104|P|your medical history, especially of: history of an allergic||
1281|105|P|reaction which included swelling of the face/lips/tongue/throat||
1281|106|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
1281|107|P|dialysis), high level of potassium in the blood.||
1281|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1281|109|P|can make you more dizzy. Do not drive, use machinery, or do||
1281|110|P|anything that needs alertness until you can do it safely. Limit||
1281|111|P|alcoholic beverages. Talk to your doctor if you are using||
1281|112|P|marijuana (cannabis).||
1281|113|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1281|114|P|and cause you to feel lightheaded. Tell your doctor if you have||
1281|115|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1281|116|P|of fluids unless your doctor tells you not to.||
1281|117|P|   Before having surgery, tell your doctor or dentist about all||
1281|118|P|the products you use (including prescription drugs,||
1281|119|P|nonprescription drugs, and herbal products).||
1281|120|P|   This product may increase your potassium levels. Before using||
1281|121|P|potassium supplements or salt substitutes that contain potassium,||
1281|122|P|consult your doctor or pharmacist.||
1281|123|P|   Older adults may be more sensitive to the side effects of this||
1281|124|P|drug, including dizziness and increases in potassium level.||
1281|125|P|   Tell your doctor if you are pregnant or plan to become||
1281|126|P|pregnant. You should not become pregnant while using fosinopril.||
1281|127|P|Fosinopril may harm an unborn baby. If you become pregnant, talk||
1281|128|P|to your doctor right away about the risks and benefits of this||
1281|129|P|medication. (See also Warning section.)||
1281|130|P|   This medication passes into breast milk. Consult your doctor||
1281|131|P|before breastfeeding.||
1281|132|B|||
1281|133|I|DRUG INTERACTIONS:  See also How to Use and Precautions section.||
1281|134|I|   Drug interactions may change how your medications work or||
1281|135|I|increase your risk for serious side effects. This document does||
1281|136|I|not contain all possible drug interactions. Keep a list of all||
1281|137|I|the products you use (including prescription/nonprescription||
1281|138|I|drugs and herbal products) and share it with your doctor and||
1281|139|I|pharmacist. Do not start, stop, or change the dosage of any||
1281|140|I|medicines without your doctor's approval.||
1281|141|I|   Some products that may interact with this drug include:||
1281|142|I|aliskiren, certain drugs that weaken the immune system/increase||
1281|143|I|the risk of infection (such as everolimus, sirolimus), lithium,||
1281|144|I|drugs that may increase the level of potassium in the blood (such||
1281|145|I|as ARBs including losartan/valsartan, birth control pills||
1281|146|I|containing drospirenone), sacubitril.||
1281|147|I|   Some products have ingredients that could raise your blood||
1281|148|I|pressure or worsen your heart failure. Tell your pharmacist what||
1281|149|I|products you are using, and ask how to use them safely||
1281|150|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
1281|151|I|ibuprofen/naproxen).||
1281|152|I|   A very serious reaction may occur if you are getting||
1281|153|I|injections for bee/wasp sting allergy (desensitization) and are||
1281|154|I|also taking fosinopril. Make sure all your doctors know which||
1281|155|I|medicines you are using.||
1281|156|I|   This medication may interfere with certain lab tests (such as||
1281|157|I|digoxin levels), possibly causing false test results. Make sure||
1281|158|I|lab personnel and all your doctors know you use this drug.||
1281|159|B|||
1281|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1281|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1281|162|O|poison control center right away. US residents can call||
1281|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1281|164|O|Symptoms of overdose may include: severe dizziness, fainting.||
1281|165|B|||
1281|166|N|NOTES:  Do not share this medication with others.||
1281|167|N|   Lifestyle changes such as stress reduction programs, exercise||
1281|168|N|and dietary changes may increase the effectiveness of this||
1281|169|N|medicine. Talk to your doctor or pharmacist about lifestyle||
1281|170|N|changes that might benefit you.||
1281|171|N|   Lab and/or medical tests (such as kidney function, potassium||
1281|172|N|levels) should be done while you are taking this medication. Keep||
1281|173|N|all medical and lab appointments. Consult your doctor for more||
1281|174|N|details.||
1281|175|N|   Check your blood pressure regularly while taking this||
1281|176|N|medication. Learn how to monitor your own blood pressure at home,||
1281|177|N|and share the results with your doctor.||
1281|178|B|||
1281|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1281|180|D|remember. If it is near the time of the next dose, skip the||
1281|181|D|missed dose. Take your next dose at the regular time. Do not||
1281|182|D|double the dose to catch up.||
1281|183|B|||
1281|184|R|STORAGE:  Store at room temperature away from light and moisture.||
1281|185|R|Do not store in the bathroom. Keep all medications away from||
1281|186|R|children and pets.||
1281|187|R|   Do not flush medications down the toilet or pour them into a||
1281|188|R|drain unless instructed to do so. Properly discard this product||
1281|189|R|when it is expired or no longer needed. Consult your pharmacist||
1281|190|R|or local waste disposal company.||
1281|191|B|||
1281|192|A|Information last revised May 2024.||
1281|193|A|Copyright(c) 2025 First Databank, Inc.||
1281|194|B|||
1284|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1284|002|Z|does NOT have all possible information about this product. This||
1284|003|Z|information does not assure that this product is safe, effective,||
1284|004|Z|or appropriate for you. This information is not individual||
1284|005|Z|medical advice and does not substitute for the advice of your||
1284|006|Z|health care professional. Always ask your health care||
1284|007|Z|professional for complete information about this product and your||
1284|008|Z|specific health needs.||
1284|009|B|||
1284|010|T|AMLODIPINE/ATORVASTATIN - ORAL||
1284|011|F|(am-LOE-di-peen/a-TOR-va-STAT-in)||
1284|012|B|||
1284|013|C|COMMON BRAND NAME(S): Caduet||
1284|014|B|||
1284|015|U|USES:  This product contains 2 medications: amlodipine and||
1284|016|U|atorvastatin. Amlodipine is a calcium channel blocker and is used||
1284|017|U|to treat high blood pressure or prevent chest pain (angina). It||
1284|018|U|works by relaxing the blood vessels so that blood can flow more||
1284|019|U|easily and the heart does not need to work so hard. Lowering high||
1284|020|U|blood pressure helps prevent strokes, heart attacks, and kidney||
1284|021|U|problems. Preventing chest pain can help improve your ability to||
1284|022|U|exercise.||
1284|023|U|   Atorvastatin is used along with a proper diet to help lower||
1284|024|U|"bad" cholesterol and fats (such as LDL, triglycerides) and raise||
1284|025|U|"good" cholesterol (HDL) in the blood. It belongs to a group of||
1284|026|U|drugs known as "statins." It works by reducing the amount of||
1284|027|U|cholesterol made by the liver. Lowering "bad" cholesterol and||
1284|028|U|triglycerides and raising "good" cholesterol decreases the risk||
1284|029|U|of heart disease and helps prevent strokes and heart attacks. In||
1284|030|U|addition to eating a proper diet (such as a||
1284|031|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
1284|032|U|help this medication work better include exercising, losing||
1284|033|U|weight if overweight, and stopping smoking. Consult your doctor||
1284|034|U|for more details.||
1284|035|B|||
1284|036|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1284|037|H|from your pharmacist before you start taking this medication and||
1284|038|H|each time you get a refill. If you have any questions, ask your||
1284|039|H|doctor or pharmacist.||
1284|040|H|   Take this medication by mouth with or without food as directed||
1284|041|H|by your doctor, usually once daily.||
1284|042|H|   The dosage is based on your medical condition, response to||
1284|043|H|treatment, age, and other medications you may be taking. Be sure||
1284|044|H|to tell your doctor and pharmacist about all the products you use||
1284|045|H|(including prescription drugs, nonprescription drugs, and herbal||
1284|046|H|products).||
1284|047|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1284|048|H|using this medication unless your doctor or pharmacist says you||
1284|049|H|may do so safely. Grapefruit can increase the chance of side||
1284|050|H|effects with this medicine. Ask your doctor or pharmacist for||
1284|051|H|more details.||
1284|052|H|   If you also take certain other drugs to lower your cholesterol||
1284|053|H|(bile acid-binding resins such as cholestyramine or colestipol),||
1284|054|H|take this product at least 1 hour before or at least 4 hours||
1284|055|H|after taking these medications. These products can react with||
1284|056|H|atorvastatin, preventing its full absorption.||
1284|057|H|   Take this medication regularly in order to get the most||
1284|058|H|benefit from it. Remember to take it at the same time each day.||
1284|059|H|It may take up to 2 weeks before you get the full benefit of||
1284|060|H|amlodipine, and up to 4 weeks before you get the full benefit of||
1284|061|H|atorvastatin.||
1284|062|H|   Keep taking this medication even if you feel well. Most people||
1284|063|H|with high blood pressure or high cholesterol/triglycerides do not||
1284|064|H|feel sick.||
1284|065|H|   If this product is used for chest pain, it must be taken||
1284|066|H|regularly to be effective. It should not be used to treat chest||
1284|067|H|pain when it occurs. Use other medications (such as nitroglycerin||
1284|068|H|placed under the tongue) to relieve chest pain as directed by||
1284|069|H|your doctor.||
1284|070|H|   Tell your doctor if your condition does not get better or if||
1284|071|H|it gets worse (for example, your blood pressure readings remain||
1284|072|H|high or increase, your chest pain occurs more often).||
1284|073|B|||
1284|074|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
1284|075|S|body adjusts to the medication. Swelling hands/ankles/feet,||
1284|076|S|tiredness, or flushing may also occur. If any of these effects||
1284|077|S|last or get worse, tell your doctor or pharmacist promptly.||
1284|078|S|   To reduce the risk of dizziness and lightheadedness, get up||
1284|079|S|slowly when rising from a sitting or lying position.||
1284|080|S|   Remember that this medication has been prescribed because your||
1284|081|S|doctor has judged that the benefit to you is greater than the||
1284|082|S|risk of side effects. Many people using this medication do not||
1284|083|S|have serious side effects.||
1284|084|S|   A very small number of people taking atorvastatin may have||
1284|085|S|mild memory problems or confusion. If these rare effects occur,||
1284|086|S|talk to your doctor.||
1284|087|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
1284|088|S|doctor about the benefits and risks.||
1284|089|S|   Tell your doctor right away if you have any serious side||
1284|090|S|effects, including: fainting, fast/pounding heartbeat.||
1284|091|S|   This drug may rarely cause muscle problems (which can rarely||
1284|092|S|lead to very serious conditions called rhabdomyolysis and||
1284|093|S|autoimmune myopathy). Tell your doctor right away if you develop||
1284|094|S|any of these symptoms during treatment and if these symptoms last||
1284|095|S|after your doctor stops this drug: muscle||
1284|096|S|pain/tenderness/weakness (especially with fever or unusual||
1284|097|S|tiredness), signs of kidney problems (such as change in the||
1284|098|S|amount of urine).||
1284|099|S|   This medication may rarely cause liver problems. Tell your||
1284|100|S|doctor right away if you develop symptoms of liver problems,||
1284|101|S|including: nausea/vomiting that doesn't stop, yellowing||
1284|102|S|eyes/skin, dark urine, stomach/abdominal pain.||
1284|103|S|   Although this medication is effective in preventing chest pain||
1284|104|S|(angina), some people who already have severe heart disease may||
1284|105|S|rarely develop worsening chest pain or a heart attack after||
1284|106|S|starting this medication or increasing the dose. Get medical help||
1284|107|S|right away if you experience: worsening chest pain, symptoms of a||
1284|108|S|heart attack (such as chest/jaw/left arm pain, shortness of||
1284|109|S|breath, unusual sweating).||
1284|110|S|   A very serious allergic reaction to this drug is rare.||
1284|111|S|However, get medical help right away if you notice any symptoms||
1284|112|S|of a serious allergic reaction, including: rash, itching/swelling||
1284|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1284|114|S|breathing.||
1284|115|S|   This is not a complete list of possible side effects. If you||
1284|116|S|notice other effects not listed above, contact your doctor or||
1284|117|S|pharmacist.||
1284|118|S|   In the US -||
1284|119|S|   Call your doctor for medical advice about side effects. You||
1284|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1284|121|S|www.fda.gov/medwatch.||
1284|122|S|   In Canada - Call your doctor for medical advice about side||
1284|123|S|effects. You may report side effects to Health Canada at||
1284|124|S|1-866-234-2345.||
1284|125|B|||
1284|126|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1284|127|P|pharmacist if you are allergic to amlodipine or atorvastatin; or||
1284|128|P|to other calcium channel blockers (such as nifedipine); or if you||
1284|129|P|have any other allergies. This product may contain inactive||
1284|130|P|ingredients, which can cause allergic reactions or other||
1284|131|P|problems. Talk to your pharmacist for more details.||
1284|132|P|   Before using this medication, tell your doctor or pharmacist||
1284|133|P|your medical history, especially of: liver disease, kidney||
1284|134|P|disease, alcohol use, certain structural heart problems||
1284|135|P|(aortic/mitral stenosis).||
1284|136|P|   Before having surgery, tell your doctor or dentist about all||
1284|137|P|the products you use (including prescription drugs,||
1284|138|P|nonprescription drugs, and herbal products).||
1284|139|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1284|140|P|can make you more dizzy. Do not drive, use machinery, or do||
1284|141|P|anything that needs alertness until you can do it safely. Talk to||
1284|142|P|your doctor if you are using marijuana (cannabis).||
1284|143|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
1284|144|P|your risk for liver problems, especially when combined with||
1284|145|P|atorvastatin. Ask your doctor or pharmacist for more information.||
1284|146|P|   Older adults may be more sensitive to the side effects of the||
1284|147|P|drug, especially muscle problems and dizziness.||
1284|148|P|   During pregnancy, this medication should be used only when||
1284|149|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1284|150|P|benefits with your doctor.||
1284|151|P|   Amlodipine passes into breast milk. It is unknown if||
1284|152|P|atorvastatin passes into breast milk. Because of the possible||
1284|153|P|risk to the infant, breastfeeding is not recommended while using||
1284|154|P|this medication. Consult your doctor before breastfeeding.||
1284|155|B|||
1284|156|I|DRUG INTERACTIONS:  See also How to Use section.||
1284|157|I|   Drug interactions may change how your medications work or||
1284|158|I|increase your risk for serious side effects. This document does||
1284|159|I|not contain all possible drug interactions. Keep a list of all||
1284|160|I|the products you use (including prescription/nonprescription||
1284|161|I|drugs and herbal products) and share it with your doctor and||
1284|162|I|pharmacist. Do not start, stop, or change the dosage of any||
1284|163|I|medicines without your doctor's approval.||
1284|164|I|   Some products that may interact with this drug include:||
1284|165|I|daptomycin, gemfibrozil.||
1284|166|I|   Other medications can affect the removal of atorvastatin from||
1284|167|I|your body, which may affect how atorvastatin works. Examples||
1284|168|I|include glecaprevir plus pibrentasvir, telithromycin, among||
1284|169|I|others.||
1284|170|I|   Do not take any red yeast rice products while you are taking||
1284|171|I|amlodipine/atorvastatin because some red yeast rice products may||
1284|172|I|also contain a statin called lovastatin. Taking||
1284|173|I|amlodipine/atorvastatin and red yeast rice products together can||
1284|174|I|increase your risk of serious muscle and liver problems.||
1284|175|I|   Some products have ingredients that could raise your blood||
1284|176|I|pressure. Tell your pharmacist what products you are using, and||
1284|177|I|ask how to use them safely (especially cough-and-cold products,||
1284|178|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1284|179|B|||
1284|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1284|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1284|182|O|poison control center right away. US residents can call||
1284|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1284|184|O|Symptoms of overdose may include: severe dizziness, fainting,||
1284|185|O|fast heartbeat.||
1284|186|B|||
1284|187|N|NOTES:  Do not share this medication with others.||
1284|188|N|   Lab and/or medical tests (such as blood||
1284|189|N|cholesterol/triglyceride levels, liver function) should be done||
1284|190|N|while you are taking this product. Keep all medical and lab||
1284|191|N|appointments. Consult your doctor for more details.||
1284|192|N|   Check your blood pressure regularly while taking this||
1284|193|N|medication. Learn how to monitor your own blood pressure at home,||
1284|194|N|and share the results with your doctor.||
1284|195|B|||
1284|196|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1284|197|D|remember. If it is within 12 hours of the next dose, skip the||
1284|198|D|missed dose. Take your next dose at the regular time. Do not||
1284|199|D|double the dose to catch up.||
1284|200|B|||
1284|201|R|STORAGE:  Store at room temperature away from light and moisture.||
1284|202|R|Do not store in the bathroom. Keep all medications away from||
1284|203|R|children and pets.||
1284|204|R|   Do not flush medications down the toilet or pour them into a||
1284|205|R|drain unless instructed to do so. Properly discard this product||
1284|206|R|when it is expired or no longer needed. Consult your pharmacist||
1284|207|R|or local waste disposal company.||
1284|208|B|||
1284|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
1284|210|M|medical emergency. For information about enrolling in MedicAlert,||
1284|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1284|212|B|||
1284|213|A|Information last revised May 2024.||
1284|214|A|Copyright(c) 2025 First Databank, Inc.||
1284|215|B|||
1285|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1285|002|Z|does NOT have all possible information about this product. This||
1285|003|Z|information does not assure that this product is safe, effective,||
1285|004|Z|or appropriate for you. This information is not individual||
1285|005|Z|medical advice and does not substitute for the advice of your||
1285|006|Z|health care professional. Always ask your health care||
1285|007|Z|professional for complete information about this product and your||
1285|008|Z|specific health needs.||
1285|009|B|||
1285|010|T|AZTREONAM SOLUTION - INHALATION||
1285|011|F|(az-TREE-oh-nam)||
1285|012|B|||
1285|013|C|COMMON BRAND NAME(S): Cayston||
1285|014|B|||
1285|015|U|USES:  This medication is used to treat people with a certain||
1285|016|U|inherited condition (cystic fibrosis) who have an ongoing lung||
1285|017|U|infection with a certain bacteria (Pseudomonas aeruginosa).||
1285|018|U|People with cystic fibrosis produce thick, sticky mucus that can||
1285|019|U|plug up the tubes, ducts and passageways in the lungs. This can||
1285|020|U|result in serious breathing problems and infections in the lungs.||
1285|021|U|   Aztreonam belongs to a class of drugs known as beta-lactams.||
1285|022|U|Aztreonam inhalation solution works by stopping the growth of a||
1285|023|U|certain bacteria (Pseudomonas aeruginosa) that commonly infects||
1285|024|U|the lungs of people with cystic fibrosis. This effect decreases||
1285|025|U|lung infections and damage, decreases the use of other||
1285|026|U|antibiotics, and helps to improve breathing.||
1285|027|U|   This antibiotic treats only bacterial infections. It will not||
1285|028|U|work for viral infections (such as the common cold, flu). Using||
1285|029|U|any antibiotic when it is not needed can cause it to not work for||
1285|030|U|future infections.||
1285|031|B|||
1285|032|H|HOW TO USE:  Read the Patient Information Leaflet and||
1285|033|H|Instructions for Use provided by your pharmacist before you start||
1285|034|H|using this medication and each time you get a refill. This||
1285|035|H|medication is used with a special machine called a nebulizer that||
1285|036|H|changes the solution to a fine mist that you inhale. Learn and||
1285|037|H|follow all instructions for the use of this medication and the||
1285|038|H|nebulizer. Children may need help from an adult to use this||
1285|039|H|medication properly. If you have any questions, ask your doctor,||
1285|040|H|pharmacist, or respiratory therapist.||
1285|041|H|   Before treatment with inhaled aztreonam, you should inhale a||
1285|042|H|bronchodilator (such as albuterol, formoterol, salmeterol). Ask||
1285|043|H|your pharmacist or doctor how soon to pre-treat with the specific||
1285|044|H|bronchodilator you are using.||
1285|045|H|   Use this medication with the nebulizer as directed by your||
1285|046|H|doctor, usually three times a day (every 8 hours). Each treatment||
1285|047|H|lasts about 2 to 3 minutes. Do not swallow or inject this||
1285|048|H|medication. This medicine is usually used for 28 days in a row,||
1285|049|H|followed by 28 days without this medication, repeating the cycle||
1285|050|H|until your doctor directs you to stop.||
1285|051|H|   Each vial of aztreonam is for one-time use. Inspect each vial||
1285|052|H|before use. Discard the vial if the prepared solution is cloudy||
1285|053|H|or has particles in it, or if it has expired or has been stored||
1285|054|H|at room temperature for longer than 28 days. Use all of the||
1285|055|H|contents of the vial for each dose immediately after mixing the||
1285|056|H|medication. Do not mix aztreonam with any other medicines in the||
1285|057|H|nebulizer.||
1285|058|H|   Do not use other forms of aztreonam in the nebulizer. Other||
1285|059|H|forms of aztreonam may contain arginine which can cause breathing||
1285|060|H|problems if inhaled.||
1285|061|H|   For the best effect, use this antibiotic at evenly spaced||
1285|062|H|times. To help you remember, use this medication at the same||
1285|063|H|time(s) every day.||
1285|064|H|   Continue to take this medication until the full prescribed||
1285|065|H|amount is finished, even if symptoms disappear after a few days.||
1285|066|H|Stopping the medication too early may result in a return of the||
1285|067|H|infection.||
1285|068|H|   Tell your doctor if your condition does not get better or if||
1285|069|H|it gets worse.||
1285|070|B|||
1285|071|S|SIDE EFFECTS:  Cough, chest discomfort, or headache may occur. If||
1285|072|S|any of these effects last or get worse, tell your doctor or||
1285|073|S|pharmacist promptly.||
1285|074|S|   Remember that this medication has been prescribed because your||
1285|075|S|doctor has judged that the benefit to you is greater than the||
1285|076|S|risk of side effects. Many people using this medication do not||
1285|077|S|have serious side effects.||
1285|078|S|   Tell your doctor right away if you have any serious side||
1285|079|S|effects, including: wheezing.||
1285|080|S|   A very serious allergic reaction to this drug is rare.||
1285|081|S|However, get medical help right away if you notice any symptoms||
1285|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1285|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1285|084|S|breathing.||
1285|085|S|   This is not a complete list of possible side effects. If you||
1285|086|S|notice other effects not listed above, contact your doctor or||
1285|087|S|pharmacist.||
1285|088|S|   In the US -||
1285|089|S|   Call your doctor for medical advice about side effects. You||
1285|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1285|091|S|www.fda.gov/medwatch.||
1285|092|S|   In Canada - Call your doctor for medical advice about side||
1285|093|S|effects. You may report side effects to Health Canada at||
1285|094|S|1-866-234-2345.||
1285|095|B|||
1285|096|P|PRECAUTIONS:  Before using aztreonam inhalation solution, tell||
1285|097|P|your doctor or pharmacist if you are allergic to it; or to||
1285|098|P|penicillins, cephalosporins, or certain other antibiotics (such||
1285|099|P|as imipenem, meropenem); or if you have any other allergies. This||
1285|100|P|product may contain inactive ingredients, which can cause||
1285|101|P|allergic reactions or other problems. Talk to your pharmacist for||
1285|102|P|more details.||
1285|103|P|   Before using this medication, tell your doctor or pharmacist||
1285|104|P|your medical history, especially of: kidney problems.||
1285|105|P|   Aztreonam may cause live bacterial vaccines (such as typhoid||
1285|106|P|vaccine) to not work well. Tell your health care professional||
1285|107|P|that you are using aztreonam before having any||
1285|108|P|immunizations/vaccinations.||
1285|109|P|   Before having surgery, tell your doctor or dentist about all||
1285|110|P|the products you use (including prescription drugs,||
1285|111|P|nonprescription drugs, and herbal products).||
1285|112|P|   During pregnancy, this medication should be used only when||
1285|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
1285|114|P|   It is unknown if inhaled aztreonam passes into breast milk.||
1285|115|P|However, other forms of this drug pass into breast milk in very||
1285|116|P|small amounts, and many doctors consider breastfeeding safe while||
1285|117|P|using this drug. Consult your doctor before breastfeeding.||
1285|118|B|||
1285|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1285|120|I|medications work or increase your risk for serious side effects.||
1285|121|I|This document does not contain all possible drug interactions.||
1285|122|I|Keep a list of all the products you use (including||
1285|123|I|prescription/nonprescription drugs and herbal products) and share||
1285|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
1285|125|I|the dosage of any medicines without your doctor's approval.||
1285|126|I|   Some of the products that may interact with this drug include:||
1285|127|I|cefoxitin, imipenem.||
1285|128|B|||
1285|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1285|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1285|131|O|poison control center right away. US residents can call||
1285|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1285|133|B|||
1285|134|N|NOTES:  Do not share this medication with others.||
1285|135|N|   Lab and/or medical tests (such as breathing tests, bacterial||
1285|136|N|cultures) may be done while you are using this medication. Keep||
1285|137|N|all medical and lab appointments. Consult your doctor for more||
1285|138|N|details.||
1285|139|B|||
1285|140|D|MISSED DOSE:  It is important not to miss any doses. If you miss||
1285|141|D|a dose, you can still use all 3 daily doses as long as you leave||
1285|142|D|at least 4 hours between each dose. Do not double the dose to||
1285|143|D|catch up.||
1285|144|B|||
1285|145|R|STORAGE:  Store in the refrigerator away from light. This||
1285|146|R|medication may also be stored at room temperature if needed. If||
1285|147|R|the medication is stored at room temperature, discard after 28||
1285|148|R|days. Keep all medications away from children and pets.||
1285|149|R|   Do not flush medications down the toilet or pour them into a||
1285|150|R|drain unless instructed to do so. Properly discard this product||
1285|151|R|when it is expired, or no longer needed, or if it has been stored||
1285|152|R|at room temperature for more than 28 days. Consult your||
1285|153|R|pharmacist or local waste disposal company.||
1285|154|B|||
1285|155|A|Information last revised October 2024.||
1285|156|A|Copyright(c) 2025 First Databank, Inc.||
1285|157|B|||
1286|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1286|002|Z|does NOT have all possible information about this product. This||
1286|003|Z|information does not assure that this product is safe, effective,||
1286|004|Z|or appropriate for you. This information is not individual||
1286|005|Z|medical advice and does not substitute for the advice of your||
1286|006|Z|health care professional. Always ask your health care||
1286|007|Z|professional for complete information about this product and your||
1286|008|Z|specific health needs.||
1286|009|B|||
1286|010|T|BENZYL ALCOHOL LOTION - TOPICAL||
1286|011|F|(BEN-zil AL-ka hol)||
1286|012|B|||
1286|013|C|COMMON BRAND NAME(S): Ulesfia||
1286|014|B|||
1286|015|U|USES:  This medication is used to treat head lice, tiny insects||
1286|016|U|that live on and irritate your scalp.||
1286|017|U|   This drug is not recommended for use in children younger than||
1286|018|U|6 months.||
1286|019|B|||
1286|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1286|021|H|from your pharmacist before you start using benzyl alcohol and||
1286|022|H|each time you get a refill. If you have any questions, ask your||
1286|023|H|doctor or pharmacist.||
1286|024|H|   This medication is for use on the hair and scalp only. Use||
1286|025|H|this medication as directed by your doctor, usually for 2||
1286|026|H|treatments, one week apart. Since this medication does not get||
1286|027|H|rid of the lice eggs, it is important to have the second||
1286|028|H|treatment to treat any lice that might have hatched. To help you||
1286|029|H|remember, mark your calendar with a reminder.||
1286|030|H|   An adult should help you apply this medication. Cover your||
1286|031|H|eyes with a towel and keep your eyes tightly closed while the||
1286|032|H|medication is being applied. The medication should be applied to||
1286|033|H|dry hair and enough medication should be used to cover your||
1286|034|H|entire scalp and hair (including behind the ears and on the back||
1286|035|H|of the neck). Massage the medication into your hair and scalp.||
1286|036|H|Avoid getting the medication in your eyes, mouth, nose, or||
1286|037|H|vagina. If the medicine gets in any of these areas, flush with||
1286|038|H|plenty of water. Leave the medication on your hair as directed by||
1286|039|H|your doctor, usually for 10 minutes, then rinse with water. Wash||
1286|040|H|your hands after using this medication. You can shampoo your hair||
1286|041|H|right after treatment. A fine-tooth comb or lice comb may be used||
1286|042|H|afterward to help remove the treated lice and lice eggs (nits).||
1286|043|H|   Tell your doctor if your condition lasts or gets worse.||
1286|044|B|||
1286|045|S|SIDE EFFECTS:  Irritation, itching, redness, tingling, or||
1286|046|S|numbness at the application site may occur. Eye irritation may||
1286|047|S|occur if the medication gets into the eyes (see also How to Use||
1286|048|S|section). If any of these effects last or get worse, tell your||
1286|049|S|doctor or pharmacist promptly.||
1286|050|S|   Remember that this medication has been prescribed because your||
1286|051|S|doctor has judged that the benefit to you is greater than the||
1286|052|S|risk of side effects. Many people using this medication do not||
1286|053|S|have serious side effects.||
1286|054|S|   A very serious allergic reaction to this drug is rare.||
1286|055|S|However, get medical help right away if you notice any symptoms||
1286|056|S|of a serious allergic reaction, including: rash, itching/swelling||
1286|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1286|058|S|breathing.||
1286|059|S|   This is not a complete list of possible side effects. If you||
1286|060|S|notice other effects not listed above, contact your doctor or||
1286|061|S|pharmacist.||
1286|062|S|   In the US -||
1286|063|S|   Call your doctor for medical advice about side effects. You||
1286|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1286|065|S|www.fda.gov/medwatch.||
1286|066|S|   In Canada - Call your doctor for medical advice about side||
1286|067|S|effects. You may report side effects to Health Canada at||
1286|068|S|1-866-234-2345.||
1286|069|B|||
1286|070|P|PRECAUTIONS:  Before using benzyl alcohol, tell your doctor or||
1286|071|P|pharmacist if you are allergic to it; or if you have any other||
1286|072|P|allergies. This product may contain inactive ingredients, which||
1286|073|P|can cause allergic reactions or other problems. Talk to your||
1286|074|P|pharmacist for more details.||
1286|075|P|   Before using this medication, tell your doctor or pharmacist||
1286|076|P|your medical history.||
1286|077|P|   Constant or forceful scratching of the skin/scalp may lead to||
1286|078|P|a bacterial skin infection. Tell your doctor right away if you||
1286|079|P|develop worsening redness or pus.||
1286|080|P|   Children may be more sensitive to the side effects of the||
1286|081|P|drug. If you are treating an infant, make sure to tell the doctor||
1286|082|P|if your infant was born early (premature) so that the doctor can||
1286|083|P|decide if your infant is old enough to use this medication.||
1286|084|P|   During pregnancy, this medication should be used only when||
1286|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
1286|086|P|   It is unknown if this medication passes into breast milk.||
1286|087|P|Consult your doctor before breastfeeding.||
1286|088|B|||
1286|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1286|090|I|medications work or increase your risk for serious side effects.||
1286|091|I|This document does not contain all possible drug interactions.||
1286|092|I|Keep a list of all the products you use (including||
1286|093|I|prescription/nonprescription drugs and herbal products) and share||
1286|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
1286|095|I|the dosage of any medicines without your doctor's approval.||
1286|096|B|||
1286|097|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1286|098|O|has overdosed and has serious symptoms such as passing out or||
1286|099|O|trouble breathing, call 911. Otherwise, call a poison control||
1286|100|O|center right away. US residents can call 1-800-222-1222. Canada||
1286|101|O|residents can call 1-844-764-7669.||
1286|102|B|||
1286|103|N|NOTES:  Do not share this medication with others.||
1286|104|N|   To avoid spreading lice to other people or getting them again,||
1286|105|N|all recently worn/used (within 2 days before treatment) head||
1286|106|N|wear, scarves, clothing, towels, pillow cases, and bed linens||
1286|107|N|should be machine-washed with hot water and dried in a dryer (at||
1286|108|N|high setting) for at least 20 minutes. For items that cannot be||
1286|109|N|washed, the items may instead be dry cleaned, sealed in a plastic||
1286|110|N|bag for 2 weeks, or sprayed with a disinfectant that kills lice.||
1286|111|N|Brushes, combs, and hair clips should be soaked in hot water||
1286|112|N|(hotter than 130 degrees F/54 degrees C) for 10 minutes, soaked||
1286|113|N|in alcohol for 1 hour, or thrown away. Furniture and floors||
1286|114|N|should be thoroughly vacuumed.||
1286|115|N|   People who are in close contact with the infected person (such||
1286|116|N|as family members in the same household) should also be checked||
1286|117|N|for lice and nits. Treatment may be considered to prevent lice in||
1286|118|N|these people.||
1286|119|B|||
1286|120|D|MISSED DOSE:  It is important to use each dose of this medication||
1286|121|D|as scheduled. If you miss the second dose, ask your doctor or||
1286|122|D|pharmacist right away for further instructions.||
1286|123|B|||
1286|124|R|STORAGE:  Store at room temperature. Do not freeze medication.||
1286|125|R|Keep all medications away from children and pets.||
1286|126|R|   Do not flush medications down the toilet or pour them into a||
1286|127|R|drain unless instructed to do so. Properly discard this product||
1286|128|R|when it is expired or no longer needed. Consult your pharmacist||
1286|129|R|or local waste disposal company.||
1286|130|B|||
1286|131|A|Information last revised October 2024.||
1286|132|A|Copyright(c) 2025 First Databank, Inc.||
1286|133|B|||
1287|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1287|002|Z|does NOT have all possible information about this product. This||
1287|003|Z|information does not assure that this product is safe, effective,||
1287|004|Z|or appropriate for you. This information is not individual||
1287|005|Z|medical advice and does not substitute for the advice of your||
1287|006|Z|health care professional. Always ask your health care||
1287|007|Z|professional for complete information about this product and your||
1287|008|Z|specific health needs.||
1287|009|B|||
1287|010|T|PERICYAZINE - ORAL||
1287|011|F|(pair-eh-SY-uh-zeen)||
1287|012|B|||
1287|013|W|WARNING:  There may be a slightly increased risk of serious,||
1287|014|W|possibly fatal side effects (such as heart failure,||
1287|015|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1287|016|W|by older adults with dementia. This medication is not approved||
1287|017|W|for the treatment of dementia-related behavior problems. Discuss||
1287|018|W|the risks and benefits of this medication, as well as other||
1287|019|W|effective and possibly safer treatments for dementia-related||
1287|020|W|behavior problems, with the doctor.||
1287|021|B|||
1287|022|U|USES:  This medication is used to treat certain mental/mood||
1287|023|U|disorders (such as schizophrenia). Pericyazine belongs to a class||
1287|024|U|of drugs known as antipsychotics. It works by helping to restore||
1287|025|U|the balance of certain natural substances in the brain.||
1287|026|B|||
1287|027|H|HOW TO USE:  Take this medication by mouth as directed by your||
1287|028|H|doctor, usually twice daily (in the morning and evening). If you||
1287|029|H|are using the liquid drops, use the dropper that comes with the||
1287|030|H|product to carefully measure each dose. Do not use a household||
1287|031|H|spoon because you might not get the correct dose.||
1287|032|H|   The dosage is based on your medical condition, age, and||
1287|033|H|response to treatment. Your doctor may start you at a low dose||
1287|034|H|and slowly increase your dose based on your response. It may take||
1287|035|H|up to several weeks before the full benefits of this medication||
1287|036|H|take effect.||
1287|037|H|   Use this medication regularly to get the most benefit from it.||
1287|038|H|To help you remember, take it at the same times each day. Do not||
1287|039|H|increase your dose, take it more often, or use it for a longer||
1287|040|H|time than prescribed because this may increase your risk of||
1287|041|H|serious side effects. Do not stop taking this medication without||
1287|042|H|consulting your doctor. Some conditions may become worse when the||
1287|043|H|drug is suddenly stopped. Your dose may need to be gradually||
1287|044|H|decreased.||
1287|045|H|   Tell your doctor if your condition lasts or gets worse.||
1287|046|B|||
1287|047|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, blurred||
1287|048|S|vision, dry mouth, nausea, vomiting, constipation, diarrhea, and||
1287|049|S|decreased interest in sex may occur. If any of these effects last||
1287|050|S|or get worse, tell your doctor or pharmacist promptly.||
1287|051|S|   Dizziness and lightheadedness can increase the risk of||
1287|052|S|falling. Get up slowly when rising from a sitting or lying||
1287|053|S|position.||
1287|054|S|   Tell your doctor right away if any of these side effects||
1287|055|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
1287|056|S|mask-like expression of the face, drooling/trouble swallowing, or||
1287|057|S|shuffling walk. Your doctor may prescribe another medication to||
1287|058|S|decrease these side effects.||
1287|059|S|   Remember that this medication has been prescribed because your||
1287|060|S|doctor has judged that the benefit to you is greater than the||
1287|061|S|risk of side effects. Many people using this medication do not||
1287|062|S|have serious side effects.||
1287|063|S|   Tell your doctor right away if you have any serious side||
1287|064|S|effects, including: difficulty urinating, dark discoloration of||
1287|065|S|the skin/eyes, easy bleeding/bruising, mental/mood changes (such||
1287|066|S|as increased aggression/agitation, trouble sleeping), vision||
1287|067|S|changes, yellowing eyes/skin, increased thirst/urination, signs||
1287|068|S|of infection (such as sore throat that doesn't go away, fever,||
1287|069|S|chills), unexplained weight gain, swelling of the hands/feet.||
1287|070|S|   This medication may rarely cause a condition known as tardive||
1287|071|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1287|072|S|your doctor right away if you develop any||
1287|073|S|unusual/uncontrolled/repeated movements, especially of the face,||
1287|074|S|mouth, tongue, arms, or legs (such as lip smacking/puckering,||
1287|075|S|tongue thrusting, chewing, finger/toe movements).||
1287|076|S|   In rare cases, pericyazine may increase the level of a certain||
1287|077|S|natural substance in the body (prolactin). For females, this||
1287|078|S|effect may result in unwanted breast milk, missed/stopped||
1287|079|S|periods, or difficulty becoming pregnant. For males, it may||
1287|080|S|result in decreased sexual ability, inability to produce sperm,||
1287|081|S|or enlarged breasts. If you develop any of these symptoms, tell||
1287|082|S|your doctor right away.||
1287|083|S|   Rarely, males may have a painful or prolonged erection lasting||
1287|084|S|4 or more hours. If this occurs, stop using this drug and get||
1287|085|S|medical help right away, or permanent problems could occur.||
1287|086|S|   Get medical help right away if you have any very serious side||
1287|087|S|effects, including: slow heartbeat, fainting, severe dizziness,||
1287|088|S|severe muscle spasm/cramping (such as twisting neck, arching||
1287|089|S|back, eyes rolling up), seizures.||
1287|090|S|   This medication may rarely cause a very serious condition||
1287|091|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1287|092|S|right away if you have any of the following symptoms: fever,||
1287|093|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1287|094|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1287|095|S|signs of kidney problems (such as change in the amount of urine).||
1287|096|S|   A very serious allergic reaction to this drug is rare.||
1287|097|S|However, get medical help right away if you notice any symptoms||
1287|098|S|of a serious allergic reaction, including: rash, itching/swelling||
1287|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1287|100|S|breathing.||
1287|101|S|   This is not a complete list of possible side effects. If you||
1287|102|S|notice other effects not listed above, contact your doctor or||
1287|103|S|pharmacist.||
1287|104|S|   In the US -||
1287|105|S|   Call your doctor for medical advice about side effects. You||
1287|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1287|107|S|www.fda.gov/medwatch.||
1287|108|S|   In Canada - Call your doctor for medical advice about side||
1287|109|S|effects. You may report side effects to Health Canada at||
1287|110|S|1-866-234-2345.||
1287|111|B|||
1287|112|P|PRECAUTIONS:  Before taking pericyazine, tell your doctor or||
1287|113|P|pharmacist if you are allergic to it; or to other phenothiazines||
1287|114|P|(such as chlorpromazine, thioridazine); or if you have any other||
1287|115|P|allergies. This product may contain inactive ingredients, which||
1287|116|P|can cause allergic reactions or other problems. Talk to your||
1287|117|P|pharmacist for more details.||
1287|118|P|   Before using this medication, tell your doctor or pharmacist||
1287|119|P|your medical history, especially of: blood disorders/decreased||
1287|120|P|bone marrow function (such as low white blood cell count), liver||
1287|121|P|disease, heart problems (such as irregular heart rhythm, heart||
1287|122|P|valve problems), low blood pressure, seizures, trouble urinating||
1287|123|P|(such as due to an enlarged prostate), eye problems (such as||
1287|124|P|glaucoma, retinal disease), stomach/intestinal blockage problems||
1287|125|P|(such as severe constipation, paralytic ileus), a certain adrenal||
1287|126|P|gland tumor (pheochromocytoma), breathing problems (such as||
1287|127|P|severe asthma, emphysema), kidney disease.||
1287|128|P|   Pericyazine may cause a condition that affects the heart||
1287|129|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1287|130|P|serious (rarely fatal) fast/irregular heartbeat and other||
1287|131|P|symptoms (such as severe dizziness, fainting) that need medical||
1287|132|P|attention right away.||
1287|133|P|   The risk of QT prolongation may be increased if you have||
1287|134|P|certain medical conditions or are taking other drugs that may||
1287|135|P|cause QT prolongation. Before using pericyazine, tell your doctor||
1287|136|P|or pharmacist of all the drugs you take and if you have any of||
1287|137|P|the following conditions: certain heart problems (heart failure,||
1287|138|P|slow heartbeat, QT prolongation in the EKG), family history of||
1287|139|P|certain heart problems (QT prolongation in the EKG, sudden||
1287|140|P|cardiac death).||
1287|141|P|   Low levels of potassium or magnesium in the blood may also||
1287|142|P|increase your risk of QT prolongation. This risk may increase if||
1287|143|P|you use certain drugs (such as diuretics/"water pills") or if you||
1287|144|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1287|145|P|Talk to your doctor about using pericyazine safely.||
1287|146|P|   This drug may make you dizzy or drowsy or blur your vision.||
1287|147|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1287|148|P|drowsy. Do not drive, use machinery, or do anything that needs||
1287|149|P|alertness or clear vision until you can do it safely. Avoid||
1287|150|P|alcoholic beverages. Talk to your doctor if you are using||
1287|151|P|marijuana (cannabis).||
1287|152|P|   Before having surgery, tell your doctor or dentist about all||
1287|153|P|the products you use (including prescription drugs,||
1287|154|P|nonprescription drugs, and herbal products).||
1287|155|P|   This medication may make you more sensitive to the sun. Limit||
1287|156|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1287|157|P|sunscreen and wear protective clothing when outdoors. Tell your||
1287|158|P|doctor right away if you get sunburned or have skin||
1287|159|P|blisters/redness.||
1287|160|P|   This medication may make you sweat less, making you more||
1287|161|P|likely to get heat stroke. Avoid doing things that may cause you||
1287|162|P|to overheat, such as hard work or exercise in hot weather, or||
1287|163|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1287|164|P|and dress lightly. If you overheat, quickly look for a place to||
1287|165|P|cool down and rest. Get medical help right away if you have a||
1287|166|P|fever that does not go away, mental/mood changes, headache, or||
1287|167|P|dizziness.||
1287|168|P|   Older adults may be more sensitive to the side effects of this||
1287|169|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
1287|170|P|prolongation (see above). Drowsiness, dizziness, and||
1287|171|P|lightheadedness can increase the risk of falling.||
1287|172|P|   During pregnancy, this medication should be used only when||
1287|173|P|clearly needed. Babies born to mothers who have used this drug||
1287|174|P|during the last 3 months of pregnancy may rarely develop symptoms||
1287|175|P|including muscle stiffness or shakiness, drowsiness,||
1287|176|P|feeding/breathing difficulties, or constant crying. If you notice||
1287|177|P|any of these symptoms in your newborn especially during their||
1287|178|P|first month, tell the doctor right away.||
1287|179|P|   Since untreated mental/mood problems (such as schizophrenia)||
1287|180|P|can be a serious condition, do not stop taking this medication||
1287|181|P|unless directed by your doctor. If you are planning pregnancy,||
1287|182|P|become pregnant, or think you may be pregnant, immediately||
1287|183|P|discuss with your doctor the benefits and risks of using this||
1287|184|P|medication during pregnancy.||
1287|185|P|   It is unknown if this drug passes into breast milk. Consult||
1287|186|P|your doctor before breastfeeding.||
1287|187|B|||
1287|188|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1287|189|I|medications work or increase your risk for serious side effects.||
1287|190|I|This document does not contain all possible drug interactions.||
1287|191|I|Keep a list of all the products you use (including||
1287|192|I|prescription/nonprescription drugs and herbal products) and share||
1287|193|I|it with your doctor and pharmacist. Do not start, stop, or change||
1287|194|I|the dosage of any medicines without your doctor's approval.||
1287|195|I|   Some products that may interact with this drug include:||
1287|196|I|certain SSRI antidepressants (fluoxetine, fluvoxamine,||
1287|197|I|paroxetine), duloxetine, cabergoline, metrizamide, pergolide,||
1287|198|I|lithium.||
1287|199|I|   Many drugs besides pericyazine may affect the heart rhythm (QT||
1287|200|I|prolongation), including dofetilide, pimozide, procainamide,||
1287|201|I|amiodarone, quinidine, sotalol, macrolide antibiotics (such as||
1287|202|I|erythromycin), among others. Before using pericyazine, report all||
1287|203|I|medications you are currently using to your doctor or pharmacist.||
1287|204|I|   Tell your doctor or pharmacist if you are taking other||
1287|205|I|products that cause drowsiness such as opioid pain or cough||
1287|206|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1287|207|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1287|208|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1287|209|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1287|210|I|diphenhydramine).||
1287|211|I|   Check the labels on all your medicines (such as allergy or||
1287|212|I|cough-and-cold products) because they may contain ingredients||
1287|213|I|that cause drowsiness. Ask your pharmacist about using those||
1287|214|I|products safely.||
1287|215|I|   This medication may interfere with certain lab tests (such as||
1287|216|I|certain pregnancy tests), possibly causing false test results.||
1287|217|I|Make sure lab personnel and all your doctors know you use this||
1287|218|I|drug.||
1287|219|B|||
1287|220|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1287|221|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1287|222|O|poison control center right away. US residents can call||
1287|223|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1287|224|O|Symptoms of overdose may include: confusion, agitation, muscle||
1287|225|O|twitching, severe drowsiness, loss of consciousness, seizures,||
1287|226|O|irregular heartbeat.||
1287|227|B|||
1287|228|N|NOTES:  Do not share this medication with others.||
1287|229|N|   Lab and/or medical tests (such as complete blood count, liver||
1287|230|N|function, eye exams) should be done while you are taking this||
1287|231|N|medication. Keep all medical and lab appointments. Consult your||
1287|232|N|doctor for more details.||
1287|233|B|||
1287|234|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1287|235|D|remember. If it is near the time of the next dose, skip the||
1287|236|D|missed dose. Take your next dose at the regular time. Do not||
1287|237|D|double the dose to catch up.||
1287|238|B|||
1287|239|R|STORAGE:  Store at room temperature away from light and moisture.||
1287|240|R|Do not store in the bathroom. Keep all medications away from||
1287|241|R|children and pets.||
1287|242|R|   Do not flush medications down the toilet or pour them into a||
1287|243|R|drain unless instructed to do so. Properly discard this product||
1287|244|R|when it is expired or no longer needed. Consult your pharmacist||
1287|245|R|or local waste disposal company.||
1287|246|B|||
1287|247|A|Information last revised April 2025.||
1287|248|A|Copyright(c) 2025 First Databank, Inc.||
1287|249|B|||
1289|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1289|002|Z|does NOT have all possible information about this product. This||
1289|003|Z|information does not assure that this product is safe, effective,||
1289|004|Z|or appropriate for you. This information is not individual||
1289|005|Z|medical advice and does not substitute for the advice of your||
1289|006|Z|health care professional. Always ask your health care||
1289|007|Z|professional for complete information about this product and your||
1289|008|Z|specific health needs.||
1289|009|B|||
1289|010|T|NAPROXEN - ORAL||
1289|011|F|(nah-PROX-en)||
1289|012|B|||
1289|013|C|COMMON BRAND NAME(S): Aleve, Anaprox, Naprosyn||
1289|014|B|||
1289|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1289|016|W|naproxen) may rarely increase the risk for a heart attack or||
1289|017|W|stroke. This effect can happen at any time while taking this drug||
1289|018|W|but is more likely if you take it for a long time. The risk may||
1289|019|W|be greater in older adults or if you have heart disease or||
1289|020|W|increased risk for heart disease (for example, due to smoking,||
1289|021|W|family history of heart disease, or conditions such as high blood||
1289|022|W|pressure or diabetes). Do not take this drug right before or||
1289|023|W|after heart bypass surgery (CABG).||
1289|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
1289|025|W|from the stomach or intestines. This effect can occur without||
1289|026|W|warning at any time while taking this drug. Older adults may be||
1289|027|W|at higher risk for this effect.||
1289|028|W|   Stop taking naproxen and get medical help right away if you||
1289|029|W|notice any of these rare but serious side effects:||
1289|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
1289|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1289|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
1289|033|W|side of the body, trouble speaking, sudden vision changes.||
1289|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
1289|035|W|of taking this drug.||
1289|036|B|||
1289|037|U|USES:  See also Warning section.||
1289|038|U|   Naproxen is used to relieve pain from various conditions such||
1289|039|U|as headache, muscle aches, tendonitis, dental pain, and menstrual||
1289|040|U|cramps. It also reduces pain, swelling, and joint stiffness||
1289|041|U|caused by arthritis, bursitis, and gout attacks. This medication||
1289|042|U|is known as a nonsteroidal anti-inflammatory drug (NSAID). It||
1289|043|U|works by blocking your body's production of certain natural||
1289|044|U|substances that cause inflammation.||
1289|045|U|   If you are treating a chronic condition such as arthritis, ask||
1289|046|U|your doctor about non-drug treatments and/or using other||
1289|047|U|medications to treat your pain.||
1289|048|U|   Check the ingredients on the label even if you have used the||
1289|049|U|product before. The manufacturer may have changed the||
1289|050|U|ingredients. Also, products with similar names may contain||
1289|051|U|different ingredients meant for different purposes. Taking the||
1289|052|U|wrong product could harm you.||
1289|053|B|||
1289|054|H|HOW TO USE:  If you are taking the over-the-counter product, read||
1289|055|H|all directions on the product package before taking this||
1289|056|H|medication. If your doctor has prescribed this medication, read||
1289|057|H|the Medication Guide provided by your pharmacist before you start||
1289|058|H|taking naproxen and each time you get a refill. If you have any||
1289|059|H|questions, ask your doctor or pharmacist.||
1289|060|H|   Take this medication by mouth as directed by your doctor,||
1289|061|H|usually 2 or 3 times a day with a full glass of water (8||
1289|062|H|ounces/240 milliliters). Do not lie down for at least 10 minutes||
1289|063|H|after taking this drug. To prevent stomach upset, take this||
1289|064|H|medication with food, milk, or an antacid.||
1289|065|H|   The dosage is based on your medical condition and response to||
1289|066|H|treatment. To reduce your risk of stomach bleeding and other side||
1289|067|H|effects, take this medication at the lowest effective dose for||
1289|068|H|the shortest possible time. Do not increase your dose or take||
1289|069|H|this drug more often than directed by your doctor or the package||
1289|070|H|label. For ongoing conditions such as arthritis, keep taking this||
1289|071|H|medication as directed by your doctor.||
1289|072|H|   For certain conditions (such as arthritis), it may take up to||
1289|073|H|two weeks of taking this drug regularly until you get the full||
1289|074|H|benefit.||
1289|075|H|   If you are taking this drug "as needed" (not on a regular||
1289|076|H|schedule), remember that pain medications work best if they are||
1289|077|H|used as the first signs of pain occur. If you wait until the pain||
1289|078|H|has worsened, the medication may not work as well.||
1289|079|H|   Tell your doctor if your condition lasts or gets worse or if||
1289|080|H|you have a fever that lasts for more than 3 days. If you think||
1289|081|H|you may have a serious medical problem, get medical help right||
1289|082|H|away.||
1289|083|B|||
1289|084|S|SIDE EFFECTS:  See also Warning section.||
1289|085|S|   Upset stomach, nausea, heartburn, headache, drowsiness, or||
1289|086|S|dizziness may occur. If any of these effects last or get worse,||
1289|087|S|tell your doctor or pharmacist promptly.||
1289|088|S|   If your doctor has directed you to use this medication,||
1289|089|S|remember that your doctor has judged that the benefit to you is||
1289|090|S|greater than the risk of side effects. Many people using this||
1289|091|S|medication do not have serious side effects.||
1289|092|S|   This medication may raise your blood pressure. Check your||
1289|093|S|blood pressure regularly and tell your doctor if the results are||
1289|094|S|high.||
1289|095|S|   Tell your doctor right away if you have any serious side||
1289|096|S|effects, including: easy bruising/bleeding, difficult/painful||
1289|097|S|swallowing, hearing changes (such as ringing in the ears),||
1289|098|S|mental/mood changes, signs of kidney problems (such as change in||
1289|099|S|the amount of urine), vision changes, symptoms of heart failure||
1289|100|S|(such as swelling ankles/feet, unusual tiredness, unusual/sudden||
1289|101|S|weight gain).||
1289|102|S|   This drug may rarely cause serious (possibly fatal) liver||
1289|103|S|disease. Get medical help right away if you have any symptoms of||
1289|104|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1289|105|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1289|106|S|urine.||
1289|107|S|   A very serious allergic reaction to this drug is rare.||
1289|108|S|However, get medical help right away if you notice any symptoms||
1289|109|S|of a serious allergic reaction, including: fever, swollen lymph||
1289|110|S|nodes, rash, itching/swelling (especially of the||
1289|111|S|face/tongue/throat), severe dizziness, trouble breathing.||
1289|112|S|   This is not a complete list of possible side effects. If you||
1289|113|S|notice other effects not listed above, contact your doctor or||
1289|114|S|pharmacist.||
1289|115|S|   In the US -||
1289|116|S|   Call your doctor for medical advice about side effects. You||
1289|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1289|118|S|www.fda.gov/medwatch.||
1289|119|S|   In Canada - Call your doctor for medical advice about side||
1289|120|S|effects. You may report side effects to Health Canada at||
1289|121|S|1-866-234-2345.||
1289|122|B|||
1289|123|P|PRECAUTIONS:  Before taking naproxen, tell your doctor or||
1289|124|P|pharmacist if you are allergic to it; or to aspirin or other||
1289|125|P|NSAIDs (such as ibuprofen, celecoxib); or if you have any other||
1289|126|P|allergies. This product may contain inactive ingredients, which||
1289|127|P|can cause allergic reactions or other problems. Talk to your||
1289|128|P|pharmacist for more details.||
1289|129|P|   Before using this medication, tell your doctor or pharmacist||
1289|130|P|your medical history, especially of: asthma (including a history||
1289|131|P|of worsening breathing after taking aspirin or other NSAIDs),||
1289|132|P|blood disorders (such as anemia), bleeding/clotting problems,||
1289|133|P|growths in the nose (nasal polyps), heart disease (such as||
1289|134|P|previous heart attack), high blood pressure, liver disease,||
1289|135|P|stroke, swelling (edema, fluid retention),||
1289|136|P|stomach/intestinal/esophagus problems (such as bleeding,||
1289|137|P|heartburn, ulcers).||
1289|138|P|   Kidney problems can sometimes occur with the use of NSAID||
1289|139|P|medications, including naproxen. Problems are more likely to||
1289|140|P|occur if you are dehydrated, have heart failure or kidney||
1289|141|P|disease, are an older adult, or if you take certain medications||
1289|142|P|(see also Drug Interactions section). Drink plenty of fluids as||
1289|143|P|directed by your doctor to prevent dehydration and tell your||
1289|144|P|doctor right away if you have a change in the amount of urine.||
1289|145|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1289|146|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1289|147|P|machinery, or do anything that needs alertness until you can do||
1289|148|P|it safely. Talk to your doctor if you are using marijuana||
1289|149|P|(cannabis).||
1289|150|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1289|151|P|and tobacco, especially when combined with this medicine, may||
1289|152|P|increase your risk for stomach bleeding. Limit alcohol and stop||
1289|153|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
1289|154|P|may safely drink.||
1289|155|P|   This medication may make you more sensitive to the sun. Limit||
1289|156|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1289|157|P|sunscreen and wear protective clothing when outdoors. Tell your||
1289|158|P|doctor right away if you get sunburned or have skin||
1289|159|P|blisters/redness.||
1289|160|P|   Some naproxen products contain salt (sodium). Tell your doctor||
1289|161|P|if you are on a salt-restricted diet.||
1289|162|P|   Before having surgery, tell your doctor or dentist about all||
1289|163|P|the products you use (including prescription drugs,||
1289|164|P|nonprescription drugs, and herbal products).||
1289|165|P|   Older adults may be at greater risk for stomach/intestinal||
1289|166|P|bleeding, kidney problems, heart attack, and stroke while using||
1289|167|P|this drug.||
1289|168|P|   Before using this medication, women of childbearing age should||
1289|169|P|talk with their doctor(s) about the benefits and risks. Tell your||
1289|170|P|doctor if you are pregnant or if you plan to become pregnant.||
1289|171|P|This medication may harm an unborn baby and cause problems with||
1289|172|P|normal labor/delivery. It is not recommended for use in pregnancy||
1289|173|P|from 20 weeks until delivery. If your doctor decides that you||
1289|174|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1289|175|P|you should use the lowest effective dose for the shortest||
1289|176|P|possible time. You should not use this medication after 30 weeks||
1289|177|P|of pregnancy.||
1289|178|P|   This drug passes into breast milk and may have undesirable||
1289|179|P|effects on a nursing infant. Consult your doctor before||
1289|180|P|breastfeeding.||
1289|181|B|||
1289|182|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1289|183|I|medications work or increase your risk for serious side effects.||
1289|184|I|This document does not contain all possible drug interactions.||
1289|185|I|Keep a list of all the products you use (including||
1289|186|I|prescription/nonprescription drugs and herbal products) and share||
1289|187|I|it with your doctor and pharmacist. Do not start, stop, or change||
1289|188|I|the dosage of any medicines without your doctor's approval.||
1289|189|I|   Some products that may interact with this drug are: aliskiren,||
1289|190|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
1289|191|I|receptor blockers (such as losartan, valsartan), cidofovir,||
1289|192|I|corticosteroids (such as prednisone), lithium, "water pills"||
1289|193|I|(diuretics such as furosemide).||
1289|194|I|   This medication may increase the risk of bleeding when taken||
1289|195|I|with other drugs that also may cause bleeding. Examples include||
1289|196|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1289|197|I|dabigatran/enoxaparin/warfarin, among others.||
1289|198|I|   Check all prescription and nonprescription medicine labels||
1289|199|I|carefully since many medications contain pain relievers/fever||
1289|200|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
1289|201|I|ketorolac). These drugs are similar to naproxen and may increase||
1289|202|I|your risk of side effects if taken together. However, if your||
1289|203|I|doctor has told you to take low-dose aspirin to prevent heart||
1289|204|I|attack or stroke (usually 81-162 milligrams a day), you should||
1289|205|I|keep taking the aspirin unless your doctor tells you not to.||
1289|206|I|Daily use of naproxen may decrease aspirin's ability to prevent||
1289|207|I|heart attack/stroke. Talk with your doctor about the risks and||
1289|208|I|benefits. Ask about other medications that can be used to treat||
1289|209|I|pain/fever.||
1289|210|I|   This medication may interfere with certain lab tests, possibly||
1289|211|I|causing false test results. Make sure lab personnel and all your||
1289|212|I|doctors know you use this drug.||
1289|213|B|||
1289|214|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1289|215|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1289|216|O|poison control center right away. US residents can call||
1289|217|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1289|218|O|Symptoms of overdose may include: severe stomach pain, extreme||
1289|219|O|drowsiness, seizures.||
1289|220|B|||
1289|221|N|NOTES:  Do not share this medication with others.||
1289|222|N|   Lab and/or medical tests (such as blood pressure, complete||
1289|223|N|blood count, liver/kidney function) may be done while you are||
1289|224|N|taking this medication. Keep all medical and lab appointments.||
1289|225|N|Consult your doctor for more details.||
1289|226|N|   If you have arthritis, lifestyle changes (such as weight loss||
1289|227|N|if needed, strengthening/conditioning exercises) may help improve||
1289|228|N|your flexibility and joint function. Consult your doctor for||
1289|229|N|specific instructions.||
1289|230|B|||
1289|231|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
1289|232|D|(not just "as needed") and you miss a dose, take it as soon as||
1289|233|D|you remember. If it is near the time of the next dose, skip the||
1289|234|D|missed dose. Take your next dose at the regular time. Do not||
1289|235|D|double the dose to catch up.||
1289|236|B|||
1289|237|R|STORAGE:  Store at room temperature away from light and moisture.||
1289|238|R|Do not store in the bathroom. Keep all medications away from||
1289|239|R|children and pets.||
1289|240|R|   Do not flush medications down the toilet or pour them into a||
1289|241|R|drain unless instructed to do so. Properly discard this product||
1289|242|R|when it is expired or no longer needed. Consult your pharmacist||
1289|243|R|or local waste disposal company.||
1289|244|B|||
1289|245|A|Information last revised November 2025.||
1289|246|A|Copyright(c) 2025 First Databank, Inc.||
1289|247|B|||
1290|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1290|002|Z|does NOT have all possible information about this product. This||
1290|003|Z|information does not assure that this product is safe, effective,||
1290|004|Z|or appropriate for you. This information is not individual||
1290|005|Z|medical advice and does not substitute for the advice of your||
1290|006|Z|health care professional. Always ask your health care||
1290|007|Z|professional for complete information about this product and your||
1290|008|Z|specific health needs.||
1290|009|B|||
1290|010|T|USTEKINUMAB - INJECTION||
1290|011|F|(US-te-KIN-ue-mab)||
1290|012|B|||
1290|013|C|COMMON BRAND NAME(S): Imuldosa, Otulfi, Pyzchiva, Selarsdi,||
1290|014|C|Starjemza, Stelara, Steqeyma, Wezlana, Yesintek||
1290|015|B|||
1290|016|U|USES:  Ustekinumab is used to treat plaque psoriasis, a certain||
1290|017|U|type of arthritis (psoriatic arthritis), or certain bowel||
1290|018|U|conditions (Crohn's disease, ulcerative colitis). It works by||
1290|019|U|blocking certain natural proteins in your body (interleukin-12||
1290|020|U|and interleukin-23) that cause inflammation (swelling) in these||
1290|021|U|conditions. Ustekinumab does not cure these diseases, but helps||
1290|022|U|to lessen symptoms of the disease. It can help to decrease the||
1290|023|U|amount of plaques in plaque psoriasis, decrease the number of||
1290|024|U|swollen/painful joints in psoriatic arthritis, and decrease||
1290|025|U|symptoms such as abdominal pain/cramping and diarrhea in Crohn's||
1290|026|U|disease and ulcerative colitis.||
1290|027|U|   This monograph is about the following ustekinumab products:||
1290|028|U|ustekinumab, ustekinumab-aauz, ustekinumab-aekn,||
1290|029|U|ustekinumab-auub, ustekinumab-hmny, ustekinumab-kfce,||
1290|030|U|ustekinumab-srlf, ustekinumab-stba, ustekinumab-ttwe.||
1290|031|B|||
1290|032|H|HOW TO USE:  Read the Medication Guide and the Instructions for||
1290|033|H|Use provided by your pharmacist before you start using||
1290|034|H|ustekinumab and each time you get a refill. Ask your health care||
1290|035|H|professional how to prepare and use this medication. If you have||
1290|036|H|any questions, ask your doctor or pharmacist.||
1290|037|H|   Before starting this drug, you should take a tuberculosis (TB)||
1290|038|H|skin test to check for a type of tuberculosis that may not be||
1290|039|H|causing any symptoms (latent TB). If you are diagnosed with TB,||
1290|040|H|to prevent a serious TB infection you must first be treated for||
1290|041|H|it before you start ustekinumab.||
1290|042|H|   Inject this medication under the skin as directed by your||
1290|043|H|doctor. For the treatment of psoriasis or psoriatic arthritis,||
1290|044|H|the first 2 doses are usually given 4 weeks apart and then the||
1290|045|H|medication is given every 12 weeks thereafter. For the treatment||
1290|046|H|of Crohn's disease or ulcerative colitis, the first dose of this||
1290|047|H|medication is usually given by injection into a vein by a health||
1290|048|H|care professional and then the medication is given by injection||
1290|049|H|under the skin every 8 weeks thereafter. When given under the||
1290|050|H|skin, the injection is given in the upper arms, buttock, thighs,||
1290|051|H|or abdomen. The dosage is based on your weight, medical||
1290|052|H|condition, and response to treatment.||
1290|053|H|   Do not shake medication. Some brands of this medication may||
1290|054|H|contain a few small white particles while other brands should not||
1290|055|H|have any particles (see Instructions for Use). Before using,||
1290|056|H|check this product for unusual particles or discoloration. If||
1290|057|H|either is present, do not use the liquid. Before injecting each||
1290|058|H|dose, clean the skin you are going to inject into (the injection||
1290|059|H|site) with rubbing alcohol. Change the injection site each time||
1290|060|H|to lessen injury under the skin. Do not inject into skin that is||
1290|061|H|irritated, sore, or infected. To lessen bruising, do not rub the||
1290|062|H|injection site after a shot. Learn how to store and discard||
1290|063|H|medical supplies safely.||
1290|064|H|   Use this medication regularly to get the most benefit from it.||
1290|065|H|To help you remember, mark your calendar with a reminder.||
1290|066|H|   Tell your doctor if your condition does not get better or if||
1290|067|H|it gets worse.||
1290|068|B|||
1290|069|S|SIDE EFFECTS:  Bruising, itching, pain, redness, swelling, or||
1290|070|S|hardening of the skin at the injection site may occur. Injection||
1290|071|S|site reactions usually go away after 1 or 2 days. Headache, back||
1290|072|S|pain, or sinus/throat pain may also occur. If any of these||
1290|073|S|effects last or get worse, tell your doctor or pharmacist||
1290|074|S|promptly.||
1290|075|S|   Remember that this medication has been prescribed because your||
1290|076|S|doctor has judged that the benefit to you is greater than the||
1290|077|S|risk of side effects. Many people using this medication do not||
1290|078|S|have serious side effects.||
1290|079|S|   Tell your doctor right away if you have any serious side||
1290|080|S|effects, including: cough that doesn't go away, shortness of||
1290|081|S|breath.||
1290|082|S|   This medication can affect your immune system. It can lower||
1290|083|S|your body's ability to fight an infection. You may be more likely||
1290|084|S|to get serious infections, such as lung infections, bone/joint||
1290|085|S|infections, skin infections, sinus infections, or||
1290|086|S|bowel/gallbladder infections. It may also be harder to fight an||
1290|087|S|infection you already have. Tell your doctor right away if you||
1290|088|S|develop any signs of an infection (such as nausea/vomiting that||
1290|089|S|doesn't stop, worsening redness/swelling/tenderness at the||
1290|090|S|injection site after 2 days, sore throat that doesn't go away,||
1290|091|S|fever, chills, painful/frequent urination, unusual vaginal||
1290|092|S|discharge/burning/itching/odor, or severe stomach pain).||
1290|093|S|   Ustekinumab may cause a rare (sometimes fatal) condition||
1290|094|S|called PRES (posterior reversible encephalopathy syndrome). Get||
1290|095|S|medical help right away if you develop headache that doesn't go||
1290|096|S|away, seizures, sudden vision changes, mental/mood changes (such||
1290|097|S|as confusion).||
1290|098|S|   There is a rare risk of developing cancer (including skin||
1290|099|S|cancer) due to this medication. Discuss the risks and benefits of||
1290|100|S|treatment with your doctor. Tell your doctor right away if you||
1290|101|S|develop symptoms such as unusual lumps/growths, unusual skin||
1290|102|S|changes (including a sore that does not heal or a change in the||
1290|103|S|size/shape/color of a mole), swollen lymph nodes, unexplained||
1290|104|S|weight loss.||
1290|105|S|   A very serious allergic reaction to this drug is rare.||
1290|106|S|However, get medical help right away if you notice any symptoms||
1290|107|S|of a serious allergic reaction, including: rash, itching/swelling||
1290|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1290|109|S|breathing.||
1290|110|S|   This is not a complete list of possible side effects. If you||
1290|111|S|notice other effects not listed above, contact your doctor or||
1290|112|S|pharmacist.||
1290|113|S|   In the US -||
1290|114|S|   Call your doctor for medical advice about side effects. You||
1290|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1290|116|S|www.fda.gov/medwatch.||
1290|117|S|   In Canada - Call your doctor for medical advice about side||
1290|118|S|effects. You may report side effects to Health Canada at||
1290|119|S|1-866-234-2345.||
1290|120|B|||
1290|121|P|PRECAUTIONS:  Before using ustekinumab, tell your doctor or||
1290|122|P|pharmacist if you are allergic to it; or to any ustekinumab||
1290|123|P|products, or if you have any other allergies. This product may||
1290|124|P|contain inactive ingredients (such as dry natural rubber/latex||
1290|125|P|found in the needle cover of some brands), which can cause||
1290|126|P|allergic reactions or other problems. Talk to your pharmacist for||
1290|127|P|more details.||
1290|128|P|   Before using this medication, tell your doctor or pharmacist||
1290|129|P|your medical history, especially of: current/recent/returning||
1290|130|P|infection (including hepatitis and tuberculosis), cancer.||
1290|131|P|   Ustekinumab can make you more likely to get infections or may||
1290|132|P|make current infections worse. Do not have||
1290|133|P|immunizations/vaccinations without the consent of your doctor,||
1290|134|P|and avoid contact with people who have recently received oral||
1290|135|P|polio vaccine or flu vaccine inhaled through the nose. Avoid||
1290|136|P|receiving BCG vaccines for one year after completing treatment||
1290|137|P|with ustekinumab. Also, stay away from anyone who has an||
1290|138|P|infection that may easily spread (such as chickenpox, COVID-19,||
1290|139|P|measles, flu). Talk to your doctor if you have been exposed to an||
1290|140|P|infection or for more details.||
1290|141|P|   Before having surgery, tell your doctor or dentist about all||
1290|142|P|the products you use (including prescription drugs,||
1290|143|P|nonprescription drugs, and herbal products).||
1290|144|P|   During pregnancy, this medication should be used only when||
1290|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
1290|146|P|Mothers who have used this medication during pregnancy should ask||
1290|147|P|a doctor about immunizations/vaccinations for their newborn||
1290|148|P|babies.||
1290|149|P|   This drug may pass into breast milk. Consult your doctor||
1290|150|P|before breastfeeding.||
1290|151|B|||
1290|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1290|153|I|medications work or increase your risk for serious side effects.||
1290|154|I|This document does not contain all possible drug interactions.||
1290|155|I|Keep a list of all the products you use (including||
1290|156|I|prescription/nonprescription drugs and herbal products) and share||
1290|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
1290|158|I|the dosage of any medicines without your doctor's approval.||
1290|159|B|||
1290|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1290|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1290|162|O|poison control center right away. US residents can call||
1290|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1290|164|B|||
1290|165|N|NOTES:  Do not share this medication with others.||
1290|166|N|   Lab and/or medical tests (such as skin exams) should be done||
1290|167|N|while you are using this medication. Keep all medical and lab||
1290|168|N|appointments. Consult your doctor for more details.||
1290|169|B|||
1290|170|D|MISSED DOSE:  It is important to get each dose of this medication||
1290|171|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1290|172|D|right away for a new dosing schedule. Do not double the dose to||
1290|173|D|catch up.||
1290|174|B|||
1290|175|R|STORAGE:  Different brands of this medication have different||
1290|176|R|storage needs. Check the product package for instructions on how||
1290|177|R|to store your brand, or ask your pharmacist. Keep all medications||
1290|178|R|away from children and pets.||
1290|179|R|   Do not flush medications down the toilet or pour them into a||
1290|180|R|drain unless instructed to do so. Properly discard this product||
1290|181|R|when it is expired or no longer needed. Consult your pharmacist||
1290|182|R|or local waste disposal company.||
1290|183|B|||
1290|184|A|Information last revised November 2025.||
1290|185|A|Copyright(c) 2025 First Databank, Inc.||
1290|186|B|||
1291|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1291|002|Z|does NOT have all possible information about this product. This||
1291|003|Z|information does not assure that this product is safe, effective,||
1291|004|Z|or appropriate for you. This information is not individual||
1291|005|Z|medical advice and does not substitute for the advice of your||
1291|006|Z|health care professional. Always ask your health care||
1291|007|Z|professional for complete information about this product and your||
1291|008|Z|specific health needs.||
1291|009|B|||
1291|010|T|LIRAGLUTIDE (DIABETES) - INJECTION||
1291|011|F|(LIR-a-GLOO-tide)||
1291|012|B|||
1291|013|C|COMMON BRAND NAME(S): Victoza||
1291|014|B|||
1291|015|W|WARNING:  This medication has been found to cause a certain type||
1291|016|W|of thyroid tumor (thyroid C-cell tumors) in rats and mice. It is||
1291|017|W|unknown if this medication can cause similar tumors in humans.||
1291|018|W|Talk with your doctor about the benefits and risks of treatment||
1291|019|W|with this medication. This medication should not be used in||
1291|020|W|people with a personal/family history of a certain type of cancer||
1291|021|W|(medullary thyroid carcinoma) or in people with a certain||
1291|022|W|inherited disease (Multiple Endocrine Neoplasia syndrome type 2||
1291|023|W|or MEN 2). While using this medication, tell your doctor right||
1291|024|W|away if you notice any signs or symptoms of thyroid tumors,||
1291|025|W|including unusual growth or lump in the neck, difficulty||
1291|026|W|swallowing, shortness of breath, unusual/lasting hoarseness.||
1291|027|B|||
1291|028|U|USES:  Liraglutide is used either alone or with other||
1291|029|U|medications, and with a proper diet and exercise program, to||
1291|030|U|control high blood sugar. It is used in people with type 2||
1291|031|U|diabetes. Controlling high blood sugar helps prevent kidney||
1291|032|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1291|033|U|function problems. Liraglutide is also used in people with type 2||
1291|034|U|diabetes and heart disease to lower the risk of a heart attack,||
1291|035|U|stroke, or death caused by heart disease.||
1291|036|U|   Liraglutide is similar to a natural hormone in your body||
1291|037|U|(incretin). It works by causing insulin release in response to||
1291|038|U|high sugar levels (such as after a meal) and decreasing the||
1291|039|U|amount of sugar your liver makes.||
1291|040|U|   Liraglutide is not a substitute for insulin if you require||
1291|041|U|insulin treatment.||
1291|042|B|||
1291|043|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1291|044|H|provided by your pharmacist before you start using liraglutide||
1291|045|H|and each time you get a refill. Ask your health care professional||
1291|046|H|how to prepare and use this medication. If you have questions,||
1291|047|H|ask your doctor or pharmacist.||
1291|048|H|   Inject this medication under the skin as directed by your||
1291|049|H|doctor, usually once daily. The injection is given in the thigh,||
1291|050|H|abdomen, or upper arm. The dosage is based on your medical||
1291|051|H|condition and response to treatment. Your doctor will start you||
1291|052|H|on a low dose first to decrease your risk of stomach/abdominal||
1291|053|H|side effects, and gradually increase your dose. If more than 3||
1291|054|H|days have passed since your last liraglutide dose, ask your||
1291|055|H|doctor if you should restart the medication with the low dose to||
1291|056|H|reduce your chance of side effects. Follow your doctor's||
1291|057|H|instructions carefully.||
1291|058|H|   If you are also using insulin, give liraglutide and insulin as||
1291|059|H|separate injections. Do not mix them. You may inject these||
1291|060|H|medications in the same area of the body, but the injection sites||
1291|061|H|should not be next to each other.||
1291|062|H|   Before using, check this product for particles or||
1291|063|H|discoloration. If either is present, do not use the liquid.||
1291|064|H|Before injecting each dose, clean the skin you are going to||
1291|065|H|inject into (the injection site) with rubbing alcohol. Change the||
1291|066|H|injection site each time to lessen injury under the skin. To||
1291|067|H|lessen bruising, do not rub the injection site after a shot.||
1291|068|H|Learn how to store and discard medical supplies safely.||
1291|069|H|   Use this medication regularly to get the most benefit from it.||
1291|070|H|To help you remember, use it at the same time each day. Carefully||
1291|071|H|follow the medication treatment plan, meal plan, and exercise||
1291|072|H|program your doctor has recommended.||
1291|073|H|   Do not share your pen device with another person, even if the||
1291|074|H|needle is changed. You may give other people a serious infection,||
1291|075|H|or get a serious infection from them.||
1291|076|H|   Tell your doctor if your condition lasts or gets worse (such||
1291|077|H|as blood sugar remaining high or increasing).||
1291|078|B|||
1291|079|S|SIDE EFFECTS:  See also Warning section.||
1291|080|S|   Nausea, vomiting, stomach upset, decreased appetite, diarrhea,||
1291|081|S|or constipation may occur. Nausea usually lessens as you continue||
1291|082|S|to use liraglutide. If any of these effects last or get worse,||
1291|083|S|tell your doctor or pharmacist promptly.||
1291|084|S|   Remember that this medication has been prescribed because your||
1291|085|S|doctor has judged that the benefit to you is greater than the||
1291|086|S|risk of side effects. Many people using this medication do not||
1291|087|S|have serious side effects.||
1291|088|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
1291|089|S|Contact your doctor promptly if you notice any symptoms of||
1291|090|S|dehydration, such as unusual dry mouth/thirst, fast heartbeat, or||
1291|091|S|dizziness/lightheadedness.||
1291|092|S|   Tell your doctor right away if you have any serious side||
1291|093|S|effects, including: signs of kidney problems (such as change in||
1291|094|S|the amount of urine), mental/mood changes (such as depression,||
1291|095|S|thoughts of suicide).||
1291|096|S|   Get medical help right away if you have any very serious side||
1291|097|S|effects, including: signs of pancreas or gallbladder disease||
1291|098|S|(such as nausea/vomiting that doesn't stop, severe||
1291|099|S|stomach/abdominal pain).||
1291|100|S|   Liraglutide does not usually cause low blood sugar||
1291|101|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1291|102|S|prescribed with other diabetes medications, or if you do not get||
1291|103|S|enough calories from food, or if you do unusually heavy exercise.||
1291|104|S|Talk with your doctor or pharmacist about whether the dose of||
1291|105|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1291|106|S|of low blood sugar include sudden sweating, shaking, fast||
1291|107|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1291|108|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1291|109|S|treat low blood sugar. If you don't have these reliable forms of||
1291|110|S|glucose, rapidly raise your blood sugar by eating a quick source||
1291|111|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1291|112|S|juice or non-diet soda. Tell your doctor right away about the||
1291|113|S|reaction and the use of this product. To help prevent low blood||
1291|114|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1291|115|S|Check with your doctor or pharmacist to find out what you should||
1291|116|S|do if you miss a meal.||
1291|117|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1291|118|S|thirst/urination. If these symptoms occur, tell your doctor right||
1291|119|S|away. Your doctor may need to adjust your diabetes medication,||
1291|120|S|exercise program, or diet.||
1291|121|S|   A very serious allergic reaction to this drug is rare.||
1291|122|S|However, get medical help right away if you notice any symptoms||
1291|123|S|of a serious allergic reaction, including: rash, itching/swelling||
1291|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1291|125|S|breathing.||
1291|126|S|   This is not a complete list of possible side effects. If you||
1291|127|S|notice other effects not listed above, contact your doctor or||
1291|128|S|pharmacist.||
1291|129|S|   In the US -||
1291|130|S|   Call your doctor for medical advice about side effects. You||
1291|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1291|132|S|www.fda.gov/medwatch.||
1291|133|S|   In Canada - Call your doctor for medical advice about side||
1291|134|S|effects. You may report side effects to Health Canada at||
1291|135|S|1-866-234-2345.||
1291|136|B|||
1291|137|P|PRECAUTIONS:  See also Warning section.||
1291|138|P|   Before using liraglutide, tell your doctor or pharmacist if||
1291|139|P|you are allergic to it; or if you have any other allergies. This||
1291|140|P|product may contain inactive ingredients, which can cause||
1291|141|P|allergic reactions or other problems. Talk to your pharmacist for||
1291|142|P|more details.||
1291|143|P|   Before using this medication, tell your doctor or pharmacist||
1291|144|P|your medical history, especially of: kidney disease, disease of||
1291|145|P|the pancreas (pancreatitis), gallbladder disease, a certain||
1291|146|P|stomach/intestinal disorder (gastroparesis), mental/mood||
1291|147|P|disorders (such as depression, thoughts of suicide).||
1291|148|P|   You may experience blurred vision, dizziness, or drowsiness||
1291|149|P|due to extremely low or high blood sugar. Do not drive, use||
1291|150|P|machinery, or do anything that needs alertness or clear vision||
1291|151|P|until you can do it safely.||
1291|152|P|   Limit alcohol while using this medication because it can||
1291|153|P|increase your risk of developing low blood sugar.||
1291|154|P|   It may be harder to control your blood sugar when your body is||
1291|155|P|stressed (such as due to fever, infection, injury, or surgery).||
1291|156|P|Consult your doctor because increased stress may require a change||
1291|157|P|in your treatment plan, medications, or blood sugar testing.||
1291|158|P|   Before having surgery, tell your doctor or dentist about all||
1291|159|P|the products you use (including prescription drugs,||
1291|160|P|nonprescription drugs, and herbal products).||
1291|161|P|   Children may be at greater risk for low blood sugar while||
1291|162|P|using this drug.||
1291|163|P|   During pregnancy, this medication should be used only when||
1291|164|P|clearly needed. Discuss the risks and benefits with your doctor.||
1291|165|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1291|166|P|your doctor for managing your blood sugar while pregnant. Your||
1291|167|P|doctor may change your diabetes treatment during your pregnancy||
1291|168|P|(such as diet and medications including insulin).||
1291|169|P|   It is unknown if this medication passes into breast milk.||
1291|170|P|Consult your doctor before breastfeeding.||
1291|171|B|||
1291|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1291|173|I|medications work or increase your risk for serious side effects.||
1291|174|I|This document does not contain all possible drug interactions.||
1291|175|I|Keep a list of all the products you use (including||
1291|176|I|prescription/nonprescription drugs and herbal products) and share||
1291|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
1291|178|I|the dosage of any medicines without your doctor's approval.||
1291|179|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1291|180|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1291|181|I|heartbeat you would usually feel when your blood sugar falls too||
1291|182|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1291|183|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1291|184|I|   Many drugs can affect your blood sugar, making it harder to||
1291|185|I|control. Examples include corticosteroids (such as prednisone),||
1291|186|I|psychiatric medicines (such as olanzapine), quinolone antibiotics||
1291|187|I|(such as ciprofloxacin), among others. Check your blood sugar||
1291|188|I|regularly as directed and share the results with your doctor.||
1291|189|I|Tell your doctor right away if you have symptoms of high or low||
1291|190|I|blood sugar (see also Side Effects section). Your doctor may need||
1291|191|I|to adjust your diabetes medication, exercise program, or diet.||
1291|192|I|   Do not use this medication with any other product that||
1291|193|I|contains liraglutide.||
1291|194|B|||
1291|195|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1291|196|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1291|197|O|poison control center right away. US residents can call||
1291|198|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1291|199|O|Symptoms of overdose may include: severe nausea/vomiting.||
1291|200|B|||
1291|201|N|NOTES:  Do not share this medication with others.||
1291|202|N|   Attend a diabetes education program to learn more about how to||
1291|203|N|manage your diabetes with medications, diet, exercise, and||
1291|204|N|regular medical exams. Learn the symptoms of high and low blood||
1291|205|N|sugar and how to treat low blood sugar. Check your blood sugar||
1291|206|N|regularly as directed and share the results with your doctor.||
1291|207|N|   Lab and/or medical tests (such as kidney function, fasting||
1291|208|N|blood glucose, hemoglobin A1c) should be done while you are using||
1291|209|N|this medication. Keep all medical and lab appointments. Consult||
1291|210|N|your doctor for more details.||
1291|211|B|||
1291|212|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1291|213|D|If it is near the time of the next dose, skip the missed dose.||
1291|214|D|Use your next dose at the regular time. Do not double the dose to||
1291|215|D|catch up.||
1291|216|B|||
1291|217|R|STORAGE:  Store unused pens in the refrigerator. Do not freeze.||
1291|218|R|Once used, this product may be stored in the refrigerator or at||
1291|219|R|room temperature away from heat and sunlight. Discard the used||
1291|220|R|pen after 30 days. Keep all medications away from children and||
1291|221|R|pets.||
1291|222|R|   Do not flush medications down the toilet or pour them into a||
1291|223|R|drain unless instructed to do so. Properly discard this product||
1291|224|R|when it is expired or no longer needed. Consult your pharmacist||
1291|225|R|or local waste disposal company.||
1291|226|B|||
1291|227|M|MEDICAL ALERT:  Your condition can cause complications in a||
1291|228|M|medical emergency. For information about enrolling in MedicAlert,||
1291|229|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1291|230|B|||
1291|231|A|Information last revised November 2025.||
1291|232|A|Copyright(c) 2025 First Databank, Inc.||
1291|233|B|||
1292|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1292|002|Z|does NOT have all possible information about this product. This||
1292|003|Z|information does not assure that this product is safe, effective,||
1292|004|Z|or appropriate for you. This information is not individual||
1292|005|Z|medical advice and does not substitute for the advice of your||
1292|006|Z|health care professional. Always ask your health care||
1292|007|Z|professional for complete information about this product and your||
1292|008|Z|specific health needs.||
1292|009|B|||
1292|010|T|ANTHRAX VACCINE - INJECTION||
1292|011|F|(AN-thrax vak-SEEN)||
1292|012|B|||
1292|013|C|COMMON BRAND NAME(S): Biothrax, Cyfendus||
1292|014|B|||
1292|015|U|USES:  This vaccine is used to help prevent serious, sometimes||
1292|016|U|fatal, infections caused by a certain bacteria (Bacillus||
1292|017|U|anthracis) in people who may be exposed to the bacteria (such as||
1292|018|U|military personnel, lab workers who handle the bacteria Bacillus||
1292|019|U|anthracis). It may also be used along with antibiotics to help||
1292|020|U|prevent getting the infection after being exposed to the||
1292|021|U|bacteria. This vaccine works by increasing the body's natural||
1292|022|U|defense (immunity) against the bacteria.||
1292|023|U|   Vaccines may not fully protect everyone who receives them.||
1292|024|B|||
1292|025|H|HOW TO USE:  Read all vaccine information available from your||
1292|026|H|health care professional before receiving the vaccine. If you||
1292|027|H|have any questions, ask your health care professional.||
1292|028|H|   This vaccine is given by injection by a health care||
1292|029|H|professional. Depending on the product, it may be given either||
1292|030|H|under the skin or into a muscle.||
1292|031|H|   Vaccines are usually given in a series of doses to provide the||
1292|032|H|best protection. Closely follow the vaccination schedule provided||
1292|033|H|by your health care professional. To help you remember, mark your||
1292|034|H|calendar with a reminder.||
1292|035|B|||
1292|036|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
1292|037|S|limited arm movement, muscle ache, headache, or tiredness may||
1292|038|S|occur. If any of these effects last or get worse, tell your||
1292|039|S|health care professional promptly.||
1292|040|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1292|041|S|vision changes, or ringing in the ears just after getting a||
1292|042|S|vaccine injection. Tell your health care professional right away||
1292|043|S|if you have any of these symptoms. Sitting or lying down may||
1292|044|S|help, since these symptoms usually don't last long.||
1292|045|S|   Remember that this vaccine has been prescribed because your||
1292|046|S|health care professional has judged that the benefit to you is||
1292|047|S|greater than the risk of side effects. Many people using this||
1292|048|S|vaccine do not have serious side effects.||
1292|049|S|   A very serious allergic reaction to this vaccine is rare.||
1292|050|S|However, get medical help right away if you notice any symptoms||
1292|051|S|of a serious allergic reaction, including: rash, itching/swelling||
1292|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1292|053|S|breathing.||
1292|054|S|   This is not a complete list of possible side effects. If you||
1292|055|S|notice other effects not listed above, contact your health care||
1292|056|S|professional.||
1292|057|S|   Contact the health care professional for medical advice about||
1292|058|S|side effects. The following numbers do not provide medical||
1292|059|S|advice, but in the US you may report side effects to the Vaccine||
1292|060|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1292|061|S|Canada, you may call the Vaccine Safety Section at Public Health||
1292|062|S|Agency of Canada at 1-866-844-0018.||
1292|063|B|||
1292|064|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
1292|065|P|care professional if you are allergic to it; or if you have any||
1292|066|P|other allergies. This product may contain inactive ingredients||
1292|067|P|(such as latex), which can cause allergic reactions or other||
1292|068|P|problems. Talk to your health care professional for more details.||
1292|069|P|   Before receiving this vaccine, tell your health care||
1292|070|P|professional your medical history, especially of: current||
1292|071|P|fever/illness, immune system disorders (such as due to HIV||
1292|072|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
1292|073|P|radiation treatment), vaccination history (including previous||
1292|074|P|reactions to any vaccines).||
1292|075|P|   This vaccine is not recommended for use during pregnancy. It||
1292|076|P|may harm an unborn baby. Consult your health care professional||
1292|077|P|for more details.||
1292|078|P|   It is unknown if this vaccine passes into breast milk. Consult||
1292|079|P|your health care professional before breastfeeding.||
1292|080|B|||
1292|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1292|082|I|medications work or increase your risk for serious side effects.||
1292|083|I|This document does not contain all possible drug interactions.||
1292|084|I|Keep a list of all the products you use (including||
1292|085|I|prescription/nonprescription drugs and herbal products) and share||
1292|086|I|it with your health care professional. Do not start, stop, or||
1292|087|I|change the dosage of any medicines without your doctor's||
1292|088|I|approval.||
1292|089|I|   Some products that may interact with this vaccine are: drugs||
1292|090|I|that weaken the immune system (including cyclosporine,||
1292|091|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1292|092|I|prednisone).||
1292|093|B|||
1292|094|O|OVERDOSE:  Not applicable.||
1292|095|B|||
1292|096|N|NOTES:  Keep all medical and lab appointments.||
1292|097|N|   Keep vaccine records for yourself and your children and||
1292|098|N|provide them to the health care professionals to prevent||
1292|099|N|unnecessary re-vaccinations.||
1292|100|B|||
1292|101|D|MISSED DOSE:  It is important that you get each vaccination as||
1292|102|D|scheduled. Ask when you should get each dose and mark your||
1292|103|D|calendar with a reminder. If you miss a dose, call the health||
1292|104|D|care professional to reschedule.||
1292|105|B|||
1292|106|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
1292|107|R|medications away from children and pets.||
1292|108|R|   Do not flush medications down the toilet or pour them into a||
1292|109|R|drain unless instructed to do so. Properly discard this product||
1292|110|R|when it is expired or no longer needed. Consult your pharmacist||
1292|111|R|or local waste disposal company.||
1292|112|B|||
1292|113|A|Information last revised February 2025.||
1292|114|A|Copyright(c) 2025 First Databank, Inc.||
1292|115|B|||
1293|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1293|002|Z|does NOT have all possible information about this product. This||
1293|003|Z|information does not assure that this product is safe, effective,||
1293|004|Z|or appropriate for you. This information is not individual||
1293|005|Z|medical advice and does not substitute for the advice of your||
1293|006|Z|health care professional. Always ask your health care||
1293|007|Z|professional for complete information about this product and your||
1293|008|Z|specific health needs.||
1293|009|B|||
1293|010|T|PONESIMOD - ORAL||
1293|011|F|(poe-NES-i-mod)||
1293|012|B|||
1293|013|C|COMMON BRAND NAME(S): Ponvory||
1293|014|B|||
1293|015|U|USES:  This medication is used to treat multiple sclerosis-MS. It||
1293|016|U|is thought to work by preventing immune system cells||
1293|017|U|(lymphocytes) from attacking the nerves in your brain and spinal||
1293|018|U|cord. Ponesimod is not a cure for MS. However, it may decrease||
1293|019|U|the number of episodes of disease worsening (relapses) and||
1293|020|U|prevent or delay disability.||
1293|021|B|||
1293|022|H|HOW TO USE:  Read the Medication Guide provided by your||
1293|023|H|pharmacist before you start taking ponesimod and each time you||
1293|024|H|get a refill. If you have any questions, ask your doctor or||
1293|025|H|pharmacist.||
1293|026|H|   Take this medication by mouth with or without food as directed||
1293|027|H|by your doctor, usually once a day. Swallow the tablets whole. Do||
1293|028|H|not split, crush, or chew the tablets.||
1293|029|H|   The dosage is based on your medical condition and response to||
1293|030|H|treatment. To reduce your risk of side effects, your doctor may||
1293|031|H|direct you to start this medication at a low dose and gradually||
1293|032|H|increase your dose. Follow your doctor's instructions carefully.||
1293|033|H|   Do not stop taking this medication without consulting your||
1293|034|H|doctor. Your condition may become worse when this drug is||
1293|035|H|stopped. Tell your doctor right away if your MS symptoms are much||
1293|036|H|worse after stopping ponesimod.||
1293|037|H|   Do not increase your dose or take this medication more often||
1293|038|H|than prescribed. Your condition will not improve any faster, and||
1293|039|H|your risk of side effects will increase.||
1293|040|H|   Take this medication regularly to get the most benefit from||
1293|041|H|it. To help you remember, take it at the same time each day.||
1293|042|H|   Tell your doctor if your condition gets worse.||
1293|043|B|||
1293|044|S|SIDE EFFECTS:  Drowsiness or dizziness may occur. If either of||
1293|045|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1293|046|S|promptly.||
1293|047|S|   Slow heartbeat may also occur, especially when you first start||
1293|048|S|this medication. Some people may need to be monitored for at||
1293|049|S|least 4 hours after the first dose to make sure their heartbeat||
1293|050|S|does not go too slow. Ask your doctor for more details.||
1293|051|S|   Remember that this medication has been prescribed because your||
1293|052|S|doctor has judged that the benefit to you is greater than the||
1293|053|S|risk of side effects. Many people using this medication do not||
1293|054|S|have serious side effects.||
1293|055|S|   This medication may raise your blood pressure. Check your||
1293|056|S|blood pressure regularly and tell your doctor if the results are||
1293|057|S|high.||
1293|058|S|   Tell your doctor right away if you have any serious side||
1293|059|S|effects, including: signs of liver disease (such as||
1293|060|S|nausea/vomiting that doesn't stop, loss of appetite,||
1293|061|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1293|062|S|shortness of breath, unusual tiredness.||
1293|063|S|   Ponesimod may rarely increase your risk of skin cancer. Tell||
1293|064|S|your doctor right away if you notice any unusual skin changes||
1293|065|S|(such as change in appearance/size of moles).||
1293|066|S|   This medication can weaken your immune system/increase the||
1293|067|S|risk of infection while you are taking it and for 1 to 2 weeks||
1293|068|S|after your last dose. You may be more likely to get a serious||
1293|069|S|(possibly fatal) infection (such as bronchitis, herpes). Tell||
1293|070|S|your doctor right away if you develop any signs of an infection||
1293|071|S|(such as sore throat that doesn't go away, fever, chills, cough,||
1293|072|S|sores, or blisters). Do not start ponesimod if you already have||
1293|073|S|an infection.||
1293|074|S|   This medication may increase your risk of getting a rare but||
1293|075|S|very serious (possibly fatal) brain infection (progressive||
1293|076|S|multifocal leukoencephalopathy-PML). Symptoms of PML can seem||
1293|077|S|like a worsening MS attack. Get medical help right away if you||
1293|078|S|have any of these side effects: clumsiness, loss of||
1293|079|S|coordination/balance, weakness, sudden change in your thinking||
1293|080|S|(such as confusion, difficulty concentrating, memory loss),||
1293|081|S|difficulty talking/walking, seizure.||
1293|082|S|   Get medical help right away if you have any very serious side||
1293|083|S|effects, including: very slow heartbeat, fast/irregular||
1293|084|S|heartbeat, severe dizziness, fainting, eye pain/sensitivity to||
1293|085|S|light, vision changes (such as blurred vision, blind spot/shadows||
1293|086|S|in the center of your vision, color changes), sudden/severe||
1293|087|S|headache.||
1293|088|S|   A very serious allergic reaction to this drug is rare.||
1293|089|S|However, get medical help right away if you notice any symptoms||
1293|090|S|of a serious allergic reaction, including: rash, itching/swelling||
1293|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1293|092|S|breathing.||
1293|093|S|   This is not a complete list of possible side effects. If you||
1293|094|S|notice other effects not listed above, contact your doctor or||
1293|095|S|pharmacist.||
1293|096|S|   In the US -||
1293|097|S|   Call your doctor for medical advice about side effects. You||
1293|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1293|099|S|www.fda.gov/medwatch.||
1293|100|S|   In Canada - Call your doctor for medical advice about side||
1293|101|S|effects. You may report side effects to Health Canada at||
1293|102|S|1-866-234-2345.||
1293|103|B|||
1293|104|P|PRECAUTIONS:  Before taking ponesimod, tell your doctor or||
1293|105|P|pharmacist if you are allergic to it; or if you have any other||
1293|106|P|allergies. This product may contain inactive ingredients which||
1293|107|P|can cause allergic reactions or other problems. Talk to your||
1293|108|P|pharmacist for more details.||
1293|109|P|   Before using this medication, tell your doctor or pharmacist||
1293|110|P|your medical history, especially of: breathing problems (such as||
1293|111|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1293|112|P|current/recent/returning infection (including herpes, hepatitis,||
1293|113|P|tuberculosis), diabetes, certain eye problems (macular edema,||
1293|114|P|uveitis), heart problems (such as slow/irregular heartbeat, heart||
1293|115|P|failure, previous heart attack, chest pain, QT prolongation in||
1293|116|P|the EKG), high blood pressure, liver problems, skin cancer,||
1293|117|P|stroke or "mini-stroke"/transient ischemic attack (TIA).||
1293|118|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1293|119|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1293|120|P|machinery, or do anything that needs alertness until you can do||
1293|121|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1293|122|P|are using marijuana (cannabis).||
1293|123|P|   Ponesimod can make you more likely to get infections or may||
1293|124|P|make current infections worse. Stay away from anyone who has an||
1293|125|P|infection that may easily spread (such as chickenpox, COVID-19,||
1293|126|P|measles, flu). Talk to your doctor if you have been exposed to an||
1293|127|P|infection or for more details.||
1293|128|P|   Tell your doctor your vaccine history and ask if you need to||
1293|129|P|get any vaccines before starting treatment with this medication.||
1293|130|P|Tell your health care professional that you are using ponesimod||
1293|131|P|before having any immunizations/vaccinations. Avoid getting a||
1293|132|P|live vaccine for 1 to 2 weeks after the last dose of this||
1293|133|P|medication. Avoid contact with people who have recently received||
1293|134|P|live vaccines (such as flu vaccine inhaled through the nose).||
1293|135|P|   This medication may increase your risk of developing skin||
1293|136|P|cancer. Limit your time in the sun. Avoid tanning booths and||
1293|137|P|sunlamps. Use sunscreen and wear protective clothing when||
1293|138|P|outdoors. Your doctor may direct you to avoid phototherapy while||
1293|139|P|you use this product. Ask your doctor for details.||
1293|140|P|   Before having surgery, tell your doctor or dentist about all||
1293|141|P|the products you use (including prescription drugs,||
1293|142|P|nonprescription drugs, and herbal products).||
1293|143|P|   Tell your doctor if you are pregnant or plan to become||
1293|144|P|pregnant. You should not become pregnant while using ponesimod.||
1293|145|P|Ponesimod may harm an unborn baby. Ask about reliable forms of||
1293|146|P|birth control while using this medication and for 1 week after||
1293|147|P|the last dose. If you become pregnant, talk to your doctor right||
1293|148|P|away about the risks and benefits of this medication.||
1293|149|P|   It is unknown if this medication passes into breast milk.||
1293|150|P|Consult your doctor before breastfeeding.||
1293|151|B|||
1293|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1293|153|I|medications work or increase your risk for serious side effects.||
1293|154|I|This document does not contain all possible drug interactions.||
1293|155|I|Keep a list of all the products you use (including||
1293|156|I|prescription/nonprescription drugs and herbal products) and share||
1293|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
1293|158|I|the dosage of any medicines without your doctor's approval.||
1293|159|I|   Some products that may interact with this drug are: other||
1293|160|I|drugs that weaken the immune system/increase the risk of||
1293|161|I|infection (such as natalizumab, rituximab).||
1293|162|B|||
1293|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1293|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1293|165|O|poison control center right away. US residents can call||
1293|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1293|167|B|||
1293|168|N|NOTES:  Do not share this medication with others.||
1293|169|N|   Lab and/or medical tests (such as complete blood count, blood||
1293|170|N|pressure, pulse, EKG, MRI, eye/skin exams, liver/lung function)||
1293|171|N|should be done before you start taking this medication and while||
1293|172|N|you are taking it. Keep all medical and lab appointments. Consult||
1293|173|N|your doctor for more details.||
1293|174|B|||
1293|175|D|MISSED DOSE:  It is very important to follow your treatment||
1293|176|D|regimen exactly. Read the manufacturer's information carefully||
1293|177|D|for missed dose instructions. If you miss 4 or more doses in a||
1293|178|D|row, contact your doctor right away. You may need to restart this||
1293|179|D|medication at a lower dose and slowly increase it. Do not double||
1293|180|D|the dose to catch up.||
1293|181|B|||
1293|182|R|STORAGE:  Store in the original package at room temperature away||
1293|183|R|from light and moisture. Do not store in the bathroom. Keep the||
1293|184|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1293|185|R|when not in use. Keep all medications away from children and||
1293|186|R|pets.||
1293|187|R|   Do not flush medications down the toilet or pour them into a||
1293|188|R|drain unless instructed to do so. Properly discard this product||
1293|189|R|when it is expired or no longer needed. Consult your pharmacist||
1293|190|R|or local waste disposal company.||
1293|191|B|||
1293|192|A|Information last revised April 2025.||
1293|193|A|Copyright(c) 2025 First Databank, Inc.||
1293|194|B|||
1296|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1296|002|Z|does NOT have all possible information about this product. This||
1296|003|Z|information does not assure that this product is safe, effective,||
1296|004|Z|or appropriate for you. This information is not individual||
1296|005|Z|medical advice and does not substitute for the advice of your||
1296|006|Z|health care professional. Always ask your health care||
1296|007|Z|professional for complete information about this product and your||
1296|008|Z|specific health needs.||
1296|009|B|||
1296|010|T|PRALATREXATE - INJECTION||
1296|011|F|(PRAL-a-TREX-ate)||
1296|012|B|||
1296|013|C|COMMON BRAND NAME(S): Folotyn||
1296|014|B|||
1296|015|U|USES:  Pralatrexate is used to treat a certain type of cancer||
1296|016|U|(peripheral T-Cell lymphoma-PTCL). Pralatrexate works by slowing||
1296|017|U|or stopping the growth of cancer cells.||
1296|018|B|||
1296|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1296|020|H|from your pharmacist before you start using pralatrexate and each||
1296|021|H|time you get a refill. If you have any questions, ask your doctor||
1296|022|H|or pharmacist.||
1296|023|H|   This medication is given by a health care professional in a||
1296|024|H|clinic or hospital. It is injected into a vein as directed by||
1296|025|H|your doctor, usually once a week for 6 weeks. Tell your doctor or||
1296|026|H|nurse right away if you notice redness, pain, or swelling during||
1296|027|H|your injection.||
1296|028|H|   The dosage is based on your body size, medical condition, and||
1296|029|H|response to treatment.||
1296|030|H|   Use this medication regularly to get the most benefit from it.||
1296|031|H|To help you remember, mark your calendar with a reminder.||
1296|032|H|   To help prevent mouth sores and other side effects, your||
1296|033|H|doctor may also direct you to take folic acid and give you||
1296|034|H|vitamin B12 shots. Carefully follow your doctor's directions for||
1296|035|H|all your medications.||
1296|036|B|||
1296|037|S|SIDE EFFECTS:  Nausea, vomiting, constipation, or diarrhea may||
1296|038|S|occur. If any of these effects last or get worse, tell your||
1296|039|S|doctor or pharmacist promptly.||
1296|040|S|   Pain or sores in the mouth and throat may occur. Brush your||
1296|041|S|teeth carefully/gently, avoid using mouthwash that contains||
1296|042|S|alcohol, and rinse your mouth often with cool water mixed with||
1296|043|S|baking soda or salt. It may also be best to eat soft, moist||
1296|044|S|foods.||
1296|045|S|   People using this medication may have serious side effects.||
1296|046|S|However, you have been prescribed this drug because your doctor||
1296|047|S|has judged that the benefit to you is greater than the risk of||
1296|048|S|side effects. Careful monitoring by your doctor may decrease your||
1296|049|S|risk.||
1296|050|S|   This medication decreases bone marrow function, an effect that||
1296|051|S|may lead to a low number of blood cells such as red cells, white||
1296|052|S|cells, and platelets. This effect can cause anemia, decrease your||
1296|053|S|body's ability to fight an infection, or cause easy||
1296|054|S|bruising/bleeding. Tell your doctor right away if you develop any||
1296|055|S|of the following symptoms: unusual tiredness, pale skin, signs of||
1296|056|S|infection (such as sore throat that doesn't go away, fever,||
1296|057|S|chills), easy bleeding/bruising.||
1296|058|S|   Tell your doctor right away if you have any serious side||
1296|059|S|effects, including: signs of dehydration (such as unusual dry||
1296|060|S|mouth/thirst, fast heartbeat, dizziness/lightheadedness), signs||
1296|061|S|of liver problems (such as nausea/vomiting that doesn't stop,||
1296|062|S|loss of appetite, stomach/abdominal pain, yellowing eyes/skin,||
1296|063|S|dark urine), shortness of breath.||
1296|064|S|   Pralatrexate sometimes causes side effects due to the rapid||
1296|065|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1296|066|S|risk, your doctor may add a medication and tell you to drink||
1296|067|S|plenty of fluids. Tell your doctor right away if you have||
1296|068|S|symptoms such as: low back/side pain (flank pain), signs of||
1296|069|S|kidney problems (such as painful urination, pink/bloody urine,||
1296|070|S|change in the amount of urine), muscle spasms/weakness.||
1296|071|S|   A very serious allergic reaction to this drug is rare.||
1296|072|S|However, get medical help right away if you notice any symptoms||
1296|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1296|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1296|075|S|breathing.||
1296|076|S|   This is not a complete list of possible side effects. If you||
1296|077|S|notice other effects not listed above, contact your doctor or||
1296|078|S|pharmacist.||
1296|079|S|   In the US -||
1296|080|S|   Call your doctor for medical advice about side effects. You||
1296|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1296|082|S|www.fda.gov/medwatch.||
1296|083|S|   In Canada - Call your doctor for medical advice about side||
1296|084|S|effects. You may report side effects to Health Canada at||
1296|085|S|1-866-234-2345.||
1296|086|B|||
1296|087|P|PRECAUTIONS:  Before using pralatrexate, tell your doctor or||
1296|088|P|pharmacist if you are allergic to it; or if you have any other||
1296|089|P|allergies. This product may contain inactive ingredients, which||
1296|090|P|can cause allergic reactions or other problems. Talk to your||
1296|091|P|pharmacist for more details.||
1296|092|P|   Before using this medication, tell your doctor or pharmacist||
1296|093|P|your medical history, especially of: kidney disease, liver||
1296|094|P|problems.||
1296|095|P|   Pralatrexate can make you more likely to get infections or may||
1296|096|P|make current infections worse. Stay away from anyone who has an||
1296|097|P|infection that may easily spread (such as chickenpox, COVID-19,||
1296|098|P|measles, flu). Talk to your doctor if you have been exposed to an||
1296|099|P|infection or for more details.||
1296|100|P|   Tell your health care professional that you are using||
1296|101|P|pralatrexate before having any immunizations/vaccinations. Avoid||
1296|102|P|contact with people who have recently received live vaccines||
1296|103|P|(such as flu vaccine inhaled through the nose).||
1296|104|P|   To lower the chance of getting cut, bruised, or injured, use||
1296|105|P|caution with sharp objects like razors and nail cutters, and||
1296|106|P|avoid activities such as contact sports.||
1296|107|P|   Before having surgery, tell your doctor or dentist about all||
1296|108|P|the products you use (including prescription drugs,||
1296|109|P|nonprescription drugs, and herbal products).||
1296|110|P|   Tell your doctor if you are pregnant or plan to become||
1296|111|P|pregnant. You should not become pregnant while using||
1296|112|P|pralatrexate. Pralatrexate may harm an unborn baby. Your doctor||
1296|113|P|may order a pregnancy test before you start this medication.||
1296|114|P|Women using this medication should ask about reliable forms of||
1296|115|P|birth control during treatment and for 6 months after the last||
1296|116|P|dose. Men using this medication should ask about reliable forms||
1296|117|P|of birth control during treatment and for 3 months after the last||
1296|118|P|dose. If you or your partner becomes pregnant, talk to your||
1296|119|P|doctor right away about the risks and benefits of this||
1296|120|P|medication.||
1296|121|P|   It is unknown if this drug passes into breast milk. Because of||
1296|122|P|the possible risk to the infant, breastfeeding is not recommended||
1296|123|P|while using this drug and for 1 week after the last dose. Consult||
1296|124|P|your doctor before breastfeeding.||
1296|125|B|||
1296|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1296|127|I|medications work or increase your risk for serious side effects.||
1296|128|I|This document does not contain all possible drug interactions.||
1296|129|I|Keep a list of all the products you use (including||
1296|130|I|prescription/nonprescription drugs and herbal products) and share||
1296|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
1296|132|I|the dosage of any medicines without your doctor's approval.||
1296|133|I|   Some of the products that may interact with this drug include:||
1296|134|I|NSAIDs (such as ibuprofen, naproxen), probenecid, sulfa||
1296|135|I|antibiotics (such as trimethoprim/sulfamethoxazole).||
1296|136|I|   Check all prescription and nonprescription medicine labels||
1296|137|I|carefully since many contain pain relievers/fever reducers||
1296|138|I|(NSAIDs) which can increase the risk of side effects when used||
1296|139|I|with pralatrexate. Ask your pharmacist about the safe use of||
1296|140|I|those products.||
1296|141|B|||
1296|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1296|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1296|144|O|poison control center right away. US residents can call||
1296|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1296|146|B|||
1296|147|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
1296|148|N|liver/kidney function) should be done before you start treatment||
1296|149|N|with this medication and while you are using it. Keep all medical||
1296|150|N|and lab appointments.||
1296|151|B|||
1296|152|D|MISSED DOSE:  It is important to get each dose of this medication||
1296|153|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1296|154|D|right away for a new dosing schedule.||
1296|155|B|||
1296|156|R|STORAGE:  Not applicable. This medication is given in a hospital||
1296|157|R|or clinic and will not be stored at home.||
1296|158|B|||
1296|159|M|MEDICAL ALERT:  Your condition can cause complications in a||
1296|160|M|medical emergency. For information about enrolling in MedicAlert,||
1296|161|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1296|162|B|||
1296|163|A|Information last revised April 2025.||
1296|164|A|Copyright(c) 2025 First Databank, Inc.||
1296|165|B|||
1297|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1297|002|Z|does NOT have all possible information about this product. This||
1297|003|Z|information does not assure that this product is safe, effective,||
1297|004|Z|or appropriate for you. This information is not individual||
1297|005|Z|medical advice and does not substitute for the advice of your||
1297|006|Z|health care professional. Always ask your health care||
1297|007|Z|professional for complete information about this product and your||
1297|008|Z|specific health needs.||
1297|009|B|||
1297|010|T|OLANZAPINE EXTENDED-RELEASE - INJECTION||
1297|011|F|(oh-LAN-za-peen)||
1297|012|B|||
1297|013|C|COMMON BRAND NAME(S): Zyprexa Relprevv||
1297|014|B|||
1297|015|W|WARNING:  This long-acting form of olanzapine injection may cause||
1297|016|W|serious side effects, including severe drowsiness, inability to||
1297|017|W|wake up (coma), and confusion (delirium) after injection. Your||
1297|018|W|doctor/healthcare professional will monitor you closely at the||
1297|019|W|healthcare facility for at least 3 hours after each injection.||
1297|020|W|Have someone drive you home after your injection.||
1297|021|W|   To receive the long acting form of olanzapine injection in the||
1297|022|W|United States, you must understand, agree to, and carefully||
1297|023|W|follow the requirements of the REMS Program for this medication.||
1297|024|W|If you live in Canada or any other country, consult your doctor||
1297|025|W|and pharmacist for your country's regulations.||
1297|026|W|   There may be a slightly increased risk of serious, possibly||
1297|027|W|fatal side effects (such as stroke, heart failure, fast/irregular||
1297|028|W|heartbeat, pneumonia) when this medication is used by older||
1297|029|W|adults with dementia. This medication is not approved for the||
1297|030|W|treatment of dementia-related behavior problems. Discuss the||
1297|031|W|risks and benefits of this medication, as well as other effective||
1297|032|W|and possibly safer treatments for dementia-related behavior||
1297|033|W|problems, with the doctor.||
1297|034|B|||
1297|035|U|USES:  This medication is used to treat a certain mental/mood||
1297|036|U|disorder (schizophrenia). Extended-release olanzapine injection||
1297|037|U|is a long-acting form of olanzapine. Olanzapine belongs to a||
1297|038|U|class of drugs known as atypical antipsychotics. It works by||
1297|039|U|helping to restore the balance of certain natural substances in||
1297|040|U|the brain.||
1297|041|U|   Talk to the doctor about the risks and benefits of treatment||
1297|042|U|(especially when used in teenagers). See also Warning and||
1297|043|U|Precautions sections.||
1297|044|B|||
1297|045|H|HOW TO USE:  Read the Medication Guide provided by your||
1297|046|H|pharmacist before you start using this medication and each time||
1297|047|H|you get an injection. If you have any questions, ask your doctor||
1297|048|H|or pharmacist.||
1297|049|H|   There are 2 types of olanzapine injection (short- and||
1297|050|H|long-acting). These 2 forms have different uses and dosing and||
1297|051|H|the 2 products are not interchangeable. There is also a form that||
1297|052|H|can be taken by mouth. The extended-release injection should only||
1297|053|H|be used if you have already taken olanzapine by mouth without any||
1297|054|H|serious side effects.||
1297|055|H|   This medication is given by injection into the buttock muscle||
1297|056|H|by a health care professional. It is given as directed by your||
1297|057|H|doctor, usually every 2 to 4 weeks. The dosage is based on your||
1297|058|H|medical condition and response to treatment.||
1297|059|H|   Use this medication regularly to get the most benefit from it.||
1297|060|H|To help you remember, mark your calendar with a reminder.||
1297|061|H|   Tell your doctor if your condition lasts or gets worse.||
1297|062|B|||
1297|063|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, nausea,||
1297|064|S|constipation, increased appetite, weight gain, dry mouth,||
1297|065|S|headache, or redness/pain/swelling at the injection site may||
1297|066|S|occur. If any of these effects last or get worse, notify your||
1297|067|S|doctor or pharmacist promptly.||
1297|068|S|   Dizziness and lightheadedness can increase the risk of||
1297|069|S|falling. Get up slowly when rising from a sitting or lying||
1297|070|S|position.||
1297|071|S|   Remember that this medication has been prescribed because your||
1297|072|S|doctor has judged that the benefit to you is greater than the||
1297|073|S|risk of side effects. Many people using this medication do not||
1297|074|S|have serious side effects.||
1297|075|S|   Olanzapine extended-release injection is designed to release||
1297|076|S|medication slowly over 2 to 4 weeks. If the medication releases||
1297|077|S|too quickly, your drug levels may be too high. Get medical help||
1297|078|S|right away if any of these symptoms of high olanzapine levels||
1297|079|S|occur: very drowsy/hard to wake up, severe dizziness, slowed||
1297|080|S|breathing, new or worsening mental/mood changes (such as||
1297|081|S|confusion, agitation, nervousness, aggression), restlessness,||
1297|082|S|muscle stiffness/spasm, shaking (tremor), unusual weakness,||
1297|083|S|difficulty walking or speaking, balance problems, seizure.||
1297|084|S|   This drug may rarely make your blood sugar rise, which can||
1297|085|S|cause or worsen diabetes. Weight gain from this drug may increase||
1297|086|S|the risk of this side effect. Tell your doctor right away if you||
1297|087|S|have symptoms of high blood sugar such as increased||
1297|088|S|thirst/urination. If you already have diabetes, check your blood||
1297|089|S|sugar regularly as directed and share the results with your||
1297|090|S|doctor. Your doctor may need to adjust your diabetes medication,||
1297|091|S|exercise program, or diet.||
1297|092|S|   This drug may cause significant weight gain and a rise in your||
1297|093|S|blood cholesterol (or triglyceride) levels, especially in||
1297|094|S|teenagers. These effects, along with diabetes, may increase your||
1297|095|S|risk for developing heart disease. Discuss the risks and benefits||
1297|096|S|of treatment with your doctor. (See also Notes section.)||
1297|097|S|   Tell your doctor right away if you have any serious side||
1297|098|S|effects, including: yellowing of the eyes/skin, difficulty||
1297|099|S|swallowing, severe stomach/abdominal pain, trouble urinating,||
1297|100|S|interrupted breathing during sleep.||
1297|101|S|   This medication may rarely cause a very serious condition||
1297|102|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1297|103|S|right away if you have any of the following symptoms: fever,||
1297|104|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1297|105|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1297|106|S|signs of kidney problems (such as change in the amount of urine).||
1297|107|S|   Olanzapine may rarely cause a condition known as tardive||
1297|108|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1297|109|S|your doctor right away if you develop any unusual/uncontrolled||
1297|110|S|movements (especially of the face or tongue).||
1297|111|S|   In rare cases, olanzapine may increase your level of a certain||
1297|112|S|substance made by the body (prolactin). For females, this||
1297|113|S|increase in prolactin may result in unwanted breast milk,||
1297|114|S|missed/stopped periods, or difficulty becoming pregnant. For||
1297|115|S|males, it may result in decreased sexual ability, inability to||
1297|116|S|produce sperm, or enlarged breasts. If you develop any of these||
1297|117|S|symptoms, tell your doctor right away.||
1297|118|S|   A very serious allergic reaction to this drug is rare.||
1297|119|S|However, get medical help right away if you notice any symptoms||
1297|120|S|of a serious allergic reaction, including: fever, swollen lymph||
1297|121|S|nodes, rash, itching/swelling (especially of the||
1297|122|S|face/tongue/throat), severe dizziness, trouble breathing.||
1297|123|S|   This is not a complete list of possible side effects. If you||
1297|124|S|notice other effects not listed above, contact your doctor or||
1297|125|S|pharmacist.||
1297|126|S|   In the US -||
1297|127|S|   Call your doctor for medical advice about side effects. You||
1297|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1297|129|S|www.fda.gov/medwatch.||
1297|130|S|   In Canada - Call your doctor for medical advice about side||
1297|131|S|effects. You may report side effects to Health Canada at||
1297|132|S|1-866-234-2345.||
1297|133|B|||
1297|134|P|PRECAUTIONS:  Before using olanzapine, tell your doctor or||
1297|135|P|pharmacist if you are allergic to it; or if you have any other||
1297|136|P|allergies. This product may contain inactive ingredients, which||
1297|137|P|can cause allergic reactions or other problems. Talk to your||
1297|138|P|pharmacist for more details.||
1297|139|P|   Before using this medication, tell your doctor or pharmacist||
1297|140|P|your medical history, especially of: liver problems, dementia,||
1297|141|P|seizures, difficulty urinating (for example, due to enlarged||
1297|142|P|prostate), glaucoma (narrow angle), stomach/intestinal problems||
1297|143|P|(such as blockage, chronic constipation, paralytic ileus),||
1297|144|P|difficulty swallowing, low white blood cell count, personal or||
1297|145|P|family history of diabetes, heart disease, high||
1297|146|P|cholesterol/triglyceride levels, breathing trouble during sleep||
1297|147|P|(sleep apnea).||
1297|148|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1297|149|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1297|150|P|machinery, or do anything that needs alertness until you can do||
1297|151|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1297|152|P|are using marijuana (cannabis). Do not drive for the rest of the||
1297|153|P|day after receiving your injection.||
1297|154|P|   This medication may make you sweat less, making you more||
1297|155|P|likely to get heat stroke. Avoid doing things that may cause you||
1297|156|P|to overheat, such as hard work or exercise in hot weather, or||
1297|157|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1297|158|P|and dress lightly. If you overheat, quickly look for a place to||
1297|159|P|cool down and rest. Get medical help right away if you have a||
1297|160|P|fever that does not go away, mental/mood changes, headache, or||
1297|161|P|dizziness.||
1297|162|P|   Teenagers may be more sensitive to the side effects of this||
1297|163|P|drug, especially weight gain, diabetes, and increased amounts of||
1297|164|P|cholesterol, triglycerides and prolactin. See also Side Effects||
1297|165|P|section for more details.||
1297|166|P|   Older adults may be more sensitive to the side effects of this||
1297|167|P|drug, especially drowsiness, constipation, trouble urinating,||
1297|168|P|confusion, dizziness, and lightheadedness. Drowsiness, confusion,||
1297|169|P|dizziness, and lightheadedness can increase the risk of falling.||
1297|170|P|   During pregnancy, this medication should be used only when||
1297|171|P|clearly needed. Babies born to mothers who have used this drug||
1297|172|P|during the last 3 months of pregnancy may rarely develop symptoms||
1297|173|P|including muscle stiffness or shakiness, drowsiness,||
1297|174|P|feeding/breathing difficulties, or constant crying. If you notice||
1297|175|P|any of these symptoms in your newborn especially during their||
1297|176|P|first month, tell the doctor right away.||
1297|177|P|   Since untreated mental/mood problems (such as schizophrenia)||
1297|178|P|can be a serious condition, do not stop taking this medication||
1297|179|P|unless directed by your doctor. If you are planning pregnancy,||
1297|180|P|become pregnant, or think you may be pregnant, immediately||
1297|181|P|discuss with your doctor the benefits and risks of using this||
1297|182|P|medication during pregnancy.||
1297|183|P|   This drug passes into breast milk and may have undesirable||
1297|184|P|effects on a nursing infant. Tell the doctor right away if your||
1297|185|P|baby develops symptoms such as muscle stiffness or shakiness,||
1297|186|P|unusual sleepiness, or difficulty feeding. Consult your doctor||
1297|187|P|before breastfeeding.||
1297|188|B|||
1297|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1297|190|I|medications work or increase your risk for serious side effects.||
1297|191|I|This document does not contain all possible drug interactions.||
1297|192|I|Keep a list of all the products you use (including||
1297|193|I|prescription/nonprescription drugs and herbal products) and share||
1297|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
1297|195|I|the dosage of any medicines without your doctor's approval.||
1297|196|I|   A product that may interact with this drug is: metoclopramide.||
1297|197|I|   Tell your doctor or pharmacist if you are taking other||
1297|198|I|products that cause drowsiness such as opioid pain or cough||
1297|199|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1297|200|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1297|201|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1297|202|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1297|203|I|diphenhydramine).||
1297|204|I|   Check the labels on all your medicines (such as allergy or||
1297|205|I|cough-and-cold products) because they may contain ingredients||
1297|206|I|that cause drowsiness. Ask your pharmacist about using those||
1297|207|I|products safely.||
1297|208|B|||
1297|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1297|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1297|211|O|poison control center right away. US residents can call||
1297|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1297|213|O|Symptoms of overdose may include: severe drowsiness, trouble||
1297|214|O|speaking, slowed breathing, or seizures.||
1297|215|B|||
1297|216|N|NOTES:  Lab and/or medical tests (such as blood sugar, complete||
1297|217|N|blood count, weight, blood fats/triglyceride levels, liver||
1297|218|N|function, blood pressure) should be done while you are using this||
1297|219|N|medication. Keep all medical and lab appointments. Consult your||
1297|220|N|doctor for more details.||
1297|221|N|   Talk with your doctor about ways to control weight gain, such||
1297|222|N|as eating a healthy, balanced diet, and exercising.||
1297|223|B|||
1297|224|D|MISSED DOSE:  It is important to get each dose of this medication||
1297|225|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1297|226|D|right away for a new dosing schedule.||
1297|227|B|||
1297|228|R|STORAGE:  Not applicable. This medication is given in a hospital||
1297|229|R|or clinic and will not be stored at home.||
1297|230|B|||
1297|231|A|Information last revised July 2025.||
1297|232|A|Copyright(c) 2025 First Databank, Inc.||
1297|233|B|||
1299|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1299|002|Z|does NOT have all possible information about this product. This||
1299|003|Z|information does not assure that this product is safe, effective,||
1299|004|Z|or appropriate for you. This information is not individual||
1299|005|Z|medical advice and does not substitute for the advice of your||
1299|006|Z|health care professional. Always ask your health care||
1299|007|Z|professional for complete information about this product and your||
1299|008|Z|specific health needs.||
1299|009|B|||
1299|010|T|DALFAMPRIDINE SUSTAINED RELEASE - ORAL||
1299|011|F|(dal-FAM-pri-deen)||
1299|012|B|||
1299|013|C|COMMON BRAND NAME(S): Ampyra||
1299|014|B|||
1299|015|U|USES:  Dalfampridine is used to improve walking in people with||
1299|016|U|multiple sclerosis (MS). It is a potassium channel blocker. It is||
1299|017|U|thought to work by improving nerve conduction.||
1299|018|B|||
1299|019|H|HOW TO USE:  Read the Medication Guide provided by your||
1299|020|H|pharmacist before you start using dalfampridine and each time you||
1299|021|H|get a refill. If you have any questions, ask your doctor or||
1299|022|H|pharmacist.||
1299|023|H|   Take this medication by mouth with or without food as directed||
1299|024|H|by your doctor, usually twice a day. Swallow this medication||
1299|025|H|whole. Do not crush, chew, or break this medication. Doing so can||
1299|026|H|release all of the drug at once, increasing the risk of side||
1299|027|H|effects. If you cannot swallow the tablets whole, talk with your||
1299|028|H|doctor.||
1299|029|H|   Dosage is based on your medical condition and response to||
1299|030|H|treatment. To reduce the risks of side effects (such as||
1299|031|H|seizures), do not take more medication or take it more often than||
1299|032|H|prescribed. Your condition will not improve any faster and your||
1299|033|H|risks of side effects will increase. Do not take more than 2||
1299|034|H|doses in a day. Take each dose 12 hours apart.||
1299|035|H|   Use this medication regularly to get the most benefit from it.||
1299|036|H|To help you remember, take it at the same times each day.||
1299|037|H|   Tell your doctor if your condition lasts or gets worse.||
1299|038|B|||
1299|039|S|SIDE EFFECTS:  Trouble sleeping (insomnia), dizziness, nausea,||
1299|040|S|and headache may occur. If any of these effects last or get||
1299|041|S|worse, tell your doctor or pharmacist promptly.||
1299|042|S|   Remember that this medication has been prescribed because your||
1299|043|S|doctor has judged that the benefit to you is greater than the||
1299|044|S|risk of side effects. Many people using this medication do not||
1299|045|S|have serious side effects.||
1299|046|S|   Tell your doctor right away if you have any serious side||
1299|047|S|effects, including: frequent/burning/painful urination, back||
1299|048|S|pain, pink/bloody urine, new/worsening balance problems.||
1299|049|S|   Get medical help right away if you have any very serious side||
1299|050|S|effects, including: mental/mood changes (such as severe||
1299|051|S|confusion, memory problems), seizure.||
1299|052|S|   A very serious allergic reaction to this drug is rare.||
1299|053|S|However, get medical help right away if you notice any symptoms||
1299|054|S|of a serious allergic reaction, including: rash, itching/swelling||
1299|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1299|056|S|breathing.||
1299|057|S|   This is not a complete list of possible side effects. If you||
1299|058|S|notice other effects not listed above, contact your doctor or||
1299|059|S|pharmacist.||
1299|060|S|   In the US -||
1299|061|S|   Call your doctor for medical advice about side effects. You||
1299|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1299|063|S|www.fda.gov/medwatch.||
1299|064|S|   In Canada - Call your doctor for medical advice about side||
1299|065|S|effects. You may report side effects to Health Canada at||
1299|066|S|1-866-234-2345.||
1299|067|B|||
1299|068|P|PRECAUTIONS:  Before taking dalfampridine, tell your doctor or||
1299|069|P|pharmacist if you are allergic to it; or if you have any other||
1299|070|P|allergies. This product may contain inactive ingredients, which||
1299|071|P|can cause allergic reactions or other problems. Talk to your||
1299|072|P|pharmacist for more details.||
1299|073|P|   Before using this medication, tell your doctor or pharmacist||
1299|074|P|your medical history, especially of: kidney disease, seizures.||
1299|075|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1299|076|P|can make you more dizzy. Do not drive, use machinery, or do||
1299|077|P|anything that needs alertness until you can do it safely. Limit||
1299|078|P|alcoholic beverages. Talk to your doctor if you are using||
1299|079|P|marijuana (cannabis).||
1299|080|P|   Before having surgery, tell your doctor or dentist about all||
1299|081|P|the products you use (including prescription drugs,||
1299|082|P|nonprescription drugs, and herbal products).||
1299|083|P|   During pregnancy, this medication should be used only when||
1299|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
1299|085|P|   It is unknown if this medication passes into breast milk.||
1299|086|P|Consult your doctor before breastfeeding.||
1299|087|B|||
1299|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1299|089|I|medications work or increase your risk for serious side effects.||
1299|090|I|This document does not contain all possible drug interactions.||
1299|091|I|Keep a list of all the products you use (including||
1299|092|I|prescription/nonprescription drugs and herbal products) and share||
1299|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
1299|094|I|the dosage of any medicines without your doctor's approval.||
1299|095|I|   Check all prescription and compounded medicine labels||
1299|096|I|carefully since this medication might be similar to other drugs||
1299|097|I|you take. Dalfampridine is also known as 4-AP, 4-aminopyridine,||
1299|098|I|and fampridine. Taking these drugs together could harm you||
1299|099|I|(increased seizure risk). Ask your doctor or pharmacist if you||
1299|100|I|are not sure about any medicines you take.||
1299|101|B|||
1299|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1299|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1299|104|O|poison control center right away. US residents can call||
1299|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1299|106|O|Symptoms of overdose may include: seizures, confusion, shaking||
1299|107|O|(tremor).||
1299|108|B|||
1299|109|N|NOTES:  Do not share this medication with others.||
1299|110|N|   Lab and/or medical tests (such as kidney function) should be||
1299|111|N|done while you are taking this medication. Keep all medical and||
1299|112|N|lab appointments. Consult your doctor for more details.||
1299|113|B|||
1299|114|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1299|115|D|next dose at the regular time. Do not double the dose to catch||
1299|116|D|up.||
1299|117|B|||
1299|118|R|STORAGE:  Store at room temperature away from light and moisture.||
1299|119|R|Do not store in the bathroom. Keep all medications away from||
1299|120|R|children and pets.||
1299|121|R|   Do not flush medications down the toilet or pour them into a||
1299|122|R|drain unless instructed to do so. Properly discard this product||
1299|123|R|when it is expired or no longer needed. Consult your pharmacist||
1299|124|R|or local waste disposal company.||
1299|125|B|||
1299|126|A|Information last revised May 2024.||
1299|127|A|Copyright(c) 2025 First Databank, Inc.||
1299|128|B|||
1302|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1302|002|Z|does NOT have all possible information about this product. This||
1302|003|Z|information does not assure that this product is safe, effective,||
1302|004|Z|or appropriate for you. This information is not individual||
1302|005|Z|medical advice and does not substitute for the advice of your||
1302|006|Z|health care professional. Always ask your health care||
1302|007|Z|professional for complete information about this product and your||
1302|008|Z|specific health needs.||
1302|009|B|||
1302|010|T|PRAMIPEXOLE EXTENDED-RELEASE - ORAL||
1302|011|F|(PRAM-i-PEX-ole)||
1302|012|B|||
1302|013|C|COMMON BRAND NAME(S): Mirapex||
1302|014|B|||
1302|015|U|USES:  Pramipexole is used alone or with other medications to||
1302|016|U|treat Parkinson's disease. It can improve your ability to move||
1302|017|U|and can decrease shakiness (tremor), stiffness, slowed movement,||
1302|018|U|and unsteadiness. It may also decrease the number of episodes of||
1302|019|U|not being able to move ("on-off syndrome").||
1302|020|U|   Pramipexole is a dopamine agonist that works by helping to||
1302|021|U|restore the balance of a certain natural substance (dopamine) in||
1302|022|U|the brain.||
1302|023|B|||
1302|024|V|OTHER USES:  This section contains uses of this drug that are not||
1302|025|V|listed in the approved professional labeling for the drug but||
1302|026|V|that may be prescribed by your health care professional. Use this||
1302|027|V|drug for a condition that is listed in this section only if it||
1302|028|V|has been so prescribed by your health care professional.||
1302|029|V|   This medication may also be used for a medical condition that||
1302|030|V|causes an unusual urge to move the legs (restless legs syndrome -||
1302|031|V|RLS) or a certain painful condition (fibromyalgia).||
1302|032|B|||
1302|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1302|034|H|from your pharmacist before you start taking pramipexole and each||
1302|035|H|time you get a refill. If you have any questions, ask your doctor||
1302|036|H|or pharmacist.||
1302|037|H|   Swallow this medication whole. Do not crush, chew, or break||
1302|038|H|the tablets. Doing so can release all of the drug at once,||
1302|039|H|increasing the risk of side effects. Take this medication by||
1302|040|H|mouth with or without food as directed by your doctor, usually||
1302|041|H|once daily. Taking this medication with food may lessen nausea.||
1302|042|H|To reduce your risk of side effects (such as drowsiness, low||
1302|043|H|blood pressure), your doctor may direct you to start this||
1302|044|H|medication at a low dose and gradually increase your dose. Follow||
1302|045|H|your doctor's instructions carefully.||
1302|046|H|   The dosage is based on your medical condition and response to||
1302|047|H|treatment. Use this medication regularly to get the most benefit||
1302|048|H|from it. To help you remember, take it at the same time each day.||
1302|049|H|Do not increase your dose or take it more often than directed.||
1302|050|H|   Do not stop taking this medication without consulting your||
1302|051|H|doctor. Some conditions may become worse when this medication is||
1302|052|H|suddenly stopped. Also, if you suddenly stop using this||
1302|053|H|medication, you may have withdrawal symptoms (such as anxiety,||
1302|054|H|depression, confusion, fever, muscle stiffness). To help prevent||
1302|055|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1302|056|H|more likely if you have used pramipexole for a long time or in||
1302|057|H|high doses. Tell your doctor or pharmacist right away if you have||
1302|058|H|withdrawal.||
1302|059|H|   If you temporarily stop taking this medication, you may need||
1302|060|H|to start this medication again at a low dose and gradually||
1302|061|H|increase your dose. Talk with your doctor about how to restart||
1302|062|H|this medication.||
1302|063|H|   It may take a few weeks for the effects of this medication to||
1302|064|H|be noticed. Tell your doctor if your condition does not get||
1302|065|H|better or if it gets worse.||
1302|066|B|||
1302|067|S|SIDE EFFECTS:  See also How to Use section.||
1302|068|S|   Nausea, vomiting, dizziness, drowsiness, lightheadedness,||
1302|069|S|trouble sleeping, constipation, headache, cough, or dry mouth may||
1302|070|S|occur. If these effects last or get worse, tell your doctor or||
1302|071|S|pharmacist promptly.||
1302|072|S|   To reduce the risk of dizziness and lightheadedness, get up||
1302|073|S|slowly when rising from a sitting or lying position.||
1302|074|S|   Tell your doctor if you see a swollen tablet or pieces of a||
1302|075|S|tablet in your stool.||
1302|076|S|   Remember that this medication has been prescribed because your||
1302|077|S|doctor has judged that the benefit to you is greater than the||
1302|078|S|risk of side effects. Many people using this medication do not||
1302|079|S|have serious side effects.||
1302|080|S|   Tell your doctor right away if you have any serious side||
1302|081|S|effects, including: mental/mood changes (such as confusion,||
1302|082|S|agitation, hallucinations), unusual strong urges (such as||
1302|083|S|increased gambling, increased sexual urges), muscle cramps/spasm,||
1302|084|S|unusual posture changes (such as the neck or body bending||
1302|085|S|forward), swelling of the ankles/feet.||
1302|086|S|   Get medical help right away if you have any very serious side||
1302|087|S|effects, including: chest pain, trouble breathing, muscle||
1302|088|S|pain/weakness, unusual tiredness, signs of kidney problems (such||
1302|089|S|as change in the amount of urine), vision changes.||
1302|090|S|   Some people taking pramipexole have fallen asleep suddenly||
1302|091|S|during their usual daily activities (such as talking on the||
1302|092|S|phone, driving). In some cases, sleep occurred without any||
1302|093|S|feelings of drowsiness beforehand. This sleep effect may occur||
1302|094|S|anytime during treatment with pramipexole even if you have used||
1302|095|S|this medication for a long time. If you experience increased||
1302|096|S|sleepiness or fall asleep during the day, do not drive or take||
1302|097|S|part in other possibly dangerous activities until you have||
1302|098|S|discussed this effect with your doctor. Your risk of this sleep||
1302|099|S|effect is increased by using alcohol or other medications that||
1302|100|S|can make you drowsy. See also Precautions section.||
1302|101|S|   A very serious allergic reaction to this drug is rare.||
1302|102|S|However, get medical help right away if you notice any symptoms||
1302|103|S|of a serious allergic reaction, including: rash, itching/swelling||
1302|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1302|105|S|breathing.||
1302|106|S|   This is not a complete list of possible side effects. If you||
1302|107|S|notice other effects not listed above, contact your doctor or||
1302|108|S|pharmacist.||
1302|109|S|   In the US -||
1302|110|S|   Call your doctor for medical advice about side effects. You||
1302|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1302|112|S|www.fda.gov/medwatch.||
1302|113|S|   In Canada - Call your doctor for medical advice about side||
1302|114|S|effects. You may report side effects to Health Canada at||
1302|115|S|1-866-234-2345.||
1302|116|B|||
1302|117|P|PRECAUTIONS:  Before taking pramipexole, tell your doctor or||
1302|118|P|pharmacist if you are allergic to it; or if you have any other||
1302|119|P|allergies. This product may contain inactive ingredients, which||
1302|120|P|can cause allergic reactions or other problems. Talk to your||
1302|121|P|pharmacist for more details.||
1302|122|P|   Before using this medication, tell your doctor or pharmacist||
1302|123|P|your medical history, especially of: low blood pressure, heart||
1302|124|P|problems (such as irregular heartbeat, heart failure), kidney||
1302|125|P|problems, mental/mood disorders (such as confusion,||
1302|126|P|hallucinations, psychosis, schizophrenia), sleep disorder (such||
1302|127|P|as sleep apnea, narcolepsy).||
1302|128|P|   Before having surgery, tell your doctor or dentist about all||
1302|129|P|the products you use (including prescription drugs,||
1302|130|P|nonprescription drugs, and herbal products).||
1302|131|P|   Older adults may be at a greater risk for dizziness and||
1302|132|P|hallucinations while using this drug.||
1302|133|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1302|134|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1302|135|P|machinery, or do anything that needs alertness until you can do||
1302|136|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1302|137|P|are using marijuana (cannabis). See also Side Effects section.||
1302|138|P|   During pregnancy, this medication should be used only when||
1302|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
1302|140|P|   It is unknown if this medication passes into breast milk.||
1302|141|P|Consult your doctor before breastfeeding.||
1302|142|B|||
1302|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1302|144|I|medications work or increase your risk for serious side effects.||
1302|145|I|This document does not contain all possible drug interactions.||
1302|146|I|Keep a list of all the products you use (including||
1302|147|I|prescription/nonprescription drugs and herbal products) and share||
1302|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
1302|149|I|the dosage of any medicines without your doctor's approval.||
1302|150|I|   Some products that may interact with this drug include:||
1302|151|I|antipsychotics (such as chlorpromazine, haloperidol,||
1302|152|I|thiothixene), cimetidine, metoclopramide.||
1302|153|I|   Tell your doctor or pharmacist if you are taking other||
1302|154|I|products that cause drowsiness including alcohol, marijuana||
1302|155|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1302|156|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1302|157|I|zolpidem), muscle relaxants (such as carisoprodol,||
1302|158|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
1302|159|I|hydrocodone).||
1302|160|I|   Check the labels on all your medicines (such as allergy or||
1302|161|I|cough-and-cold products) because they may contain ingredients||
1302|162|I|that cause drowsiness. Ask your pharmacist about using those||
1302|163|I|products safely.||
1302|164|B|||
1302|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1302|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1302|167|O|poison control center right away. US residents can call||
1302|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1302|169|B|||
1302|170|N|NOTES:  Do not share this medication with others.||
1302|171|B|||
1302|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1302|173|D|remember. If it is more than 12 hours after the missed dose, skip||
1302|174|D|the missed dose. Take your next dose at the regular time. Do not||
1302|175|D|double the dose to catch up.||
1302|176|B|||
1302|177|R|STORAGE:  Store at room temperature away from light and moisture.||
1302|178|R|Do not store in the bathroom. Keep all medications away from||
1302|179|R|children and pets.||
1302|180|R|   Do not flush medications down the toilet or pour them into a||
1302|181|R|drain unless instructed to do so. Properly discard this product||
1302|182|R|when it is expired or no longer needed. Consult your pharmacist||
1302|183|R|or local waste disposal company.||
1302|184|B|||
1302|185|A|Information last revised October 2024.||
1302|186|A|Copyright(c) 2025 First Databank, Inc.||
1302|187|B|||
1305|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1305|002|Z|does NOT have all possible information about this product. This||
1305|003|Z|information does not assure that this product is safe, effective,||
1305|004|Z|or appropriate for you. This information is not individual||
1305|005|Z|medical advice and does not substitute for the advice of your||
1305|006|Z|health care professional. Always ask your health care||
1305|007|Z|professional for complete information about this product and your||
1305|008|Z|specific health needs.||
1305|009|B|||
1305|010|T|SENNOSIDES - ORAL||
1305|011|F|(SEN-oh-sides)||
1305|012|B|||
1305|013|U|USES:  Sennosides are used to treat constipation. They may also||
1305|014|U|be used to clean out the intestines before a bowel||
1305|015|U|examination/surgery. Sennosides are known as stimulant laxatives.||
1305|016|U|They work by keeping water in the intestines, which causes||
1305|017|U|movement of the intestines.||
1305|018|B|||
1305|019|H|HOW TO USE:  Take this medication by mouth as directed by your||
1305|020|H|doctor. If you are self-treating, follow all directions on the||
1305|021|H|product package. If you have any questions, ask your doctor or||
1305|022|H|pharmacist.||
1305|023|H|   If you are using the chewable tablets, chew each tablet well||
1305|024|H|and swallow. If you are using the dissolving strips, allow each||
1305|025|H|strip to dissolve on the tongue and then swallow, with or without||
1305|026|H|water.||
1305|027|H|   If you are using the liquid form of this medication, measure||
1305|028|H|the dose carefully using a special measuring device/cup. Do not||
1305|029|H|use a household spoon because you may not get the correct dose.||
1305|030|H|Shake the container well before each dose.||
1305|031|H|   Dosage is based on your age, medical condition, and response||
1305|032|H|to treatment. Do not increase your dose or take this drug more||
1305|033|H|often than directed. Do not take this medication for more than 7||
1305|034|H|days unless directed by your doctor. Serious side effects may||
1305|035|H|occur with overuse of this medication (see also Side Effects||
1305|036|H|section).||
1305|037|H|   It may take 6 to 12 hours before this medication causes a||
1305|038|H|bowel movement. Tell your doctor if your condition lasts or gets||
1305|039|H|worse, or if bleeding from the rectum occurs. If you think you||
1305|040|H|may have a serious medical problem, get medical help right away.||
1305|041|B|||
1305|042|S|SIDE EFFECTS:  Stomach/abdominal pain or cramping, nausea,||
1305|043|S|diarrhea, or weakness may occur. If any of these effects last or||
1305|044|S|get worse, tell your doctor or pharmacist promptly.||
1305|045|S|   This medication may cause your urine to turn reddish-brown.||
1305|046|S|This effect is harmless and will disappear when the medication is||
1305|047|S|stopped.||
1305|048|S|   If your doctor has directed you to use this medication,||
1305|049|S|remember that your doctor has judged that the benefit to you is||
1305|050|S|greater than the risk of side effects. Many people using this||
1305|051|S|medication do not have serious side effects.||
1305|052|S|   Tell your doctor right away if you have any serious side||
1305|053|S|effects, including: nausea/vomiting/diarrhea that doesn't stop,||
1305|054|S|muscle cramps/weakness, irregular heartbeat, dizziness, decreased||
1305|055|S|urination, mental/mood changes (such as confusion).||
1305|056|S|   A very serious allergic reaction to this drug is rare.||
1305|057|S|However, get medical help right away if you notice any symptoms||
1305|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1305|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1305|060|S|breathing.||
1305|061|S|   This is not a complete list of possible side effects. If you||
1305|062|S|notice other effects not listed above, contact your doctor or||
1305|063|S|pharmacist.||
1305|064|S|   In the US -||
1305|065|S|   Call your doctor for medical advice about side effects. You||
1305|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1305|067|S|www.fda.gov/medwatch.||
1305|068|S|   In Canada - Call your doctor for medical advice about side||
1305|069|S|effects. You may report side effects to Health Canada at||
1305|070|S|1-866-234-2345.||
1305|071|B|||
1305|072|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1305|073|P|pharmacist if you are allergic to it; or to senna; or if you have||
1305|074|P|any other allergies. This product may contain inactive||
1305|075|P|ingredients, which can cause allergic reactions or other||
1305|076|P|problems. Talk to your pharmacist for more details.||
1305|077|P|   Before using this medication, tell your doctor or pharmacist||
1305|078|P|your medical history, especially of: appendicitis or symptoms of||
1305|079|P|appendicitis (such as nausea/vomiting, sudden or unexplained||
1305|080|P|stomach/abdominal pain), a sudden change in bowel habits that||
1305|081|P|lasts for longer than 2 weeks, bleeding from the rectum,||
1305|082|P|intestinal blockage.||
1305|083|P|   Before having surgery, tell your doctor or dentist about all||
1305|084|P|the products you use (including prescription drugs,||
1305|085|P|nonprescription drugs, and herbal products).||
1305|086|P|   Chewable tablets, liquid products, or dissolving strips may||
1305|087|P|contain sugar. Caution is advised if you have diabetes or any||
1305|088|P|other condition that requires you to limit/avoid sugar in your||
1305|089|P|diet. Ask your doctor or pharmacist about using this product||
1305|090|P|safely.||
1305|091|P|   Tell your doctor if you are pregnant before using this||
1305|092|P|medication. Using it for long periods during pregnancy is not||
1305|093|P|recommended. Consult your doctor for more details.||
1305|094|P|   This medication passes into breast milk, but is unlikely to||
1305|095|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1305|096|B|||
1305|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1305|098|I|medications work or increase your risk for serious side effects.||
1305|099|I|This document does not contain all possible drug interactions.||
1305|100|I|Keep a list of all the products you use (including||
1305|101|I|prescription/nonprescription drugs and herbal products) and share||
1305|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
1305|103|I|the dosage of any medicines without your doctor's approval.||
1305|104|B|||
1305|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1305|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1305|107|O|poison control center right away. US residents can call||
1305|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1305|109|O|Symptoms of overdose may include: nausea/vomiting/diarrhea that||
1305|110|O|doesn't stop, severe stomach/abdominal pain or cramping.||
1305|111|B|||
1305|112|N|NOTES:  Keep all medical and lab appointments.||
1305|113|N|   Lifestyle changes that may prevent or relieve constipation||
1305|114|N|include exercising, drinking enough water, and eating a proper||
1305|115|N|diet with fiber-rich foods such as bran, fresh fruits/vegetables.||
1305|116|N|Talk to your doctor or pharmacist about lifestyle changes that||
1305|117|N|might benefit you.||
1305|118|B|||
1305|119|D|MISSED DOSE:  If your doctor has directed you to take this||
1305|120|D|medication on a regular schedule and you miss a dose, take it as||
1305|121|D|soon as you remember. If it is near the time of the next dose,||
1305|122|D|skip the missed dose. Take your next dose at the regular time. Do||
1305|123|D|not double the dose to catch up.||
1305|124|B|||
1305|125|R|STORAGE:  Different brands of this medication have different||
1305|126|R|storage needs. Check the product package for instructions on how||
1305|127|R|to store your brand, or ask your pharmacist. Keep all medications||
1305|128|R|away from children and pets.||
1305|129|R|   Do not flush medications down the toilet or pour them into a||
1305|130|R|drain unless instructed to do so. Properly discard this product||
1305|131|R|when it is expired or no longer needed. Consult your pharmacist||
1305|132|R|or local waste disposal company.||
1305|133|B|||
1305|134|A|Information last revised June 2024.||
1305|135|A|Copyright(c) 2025 First Databank, Inc.||
1305|136|B|||
1306|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1306|002|Z|does NOT have all possible information about this product. This||
1306|003|Z|information does not assure that this product is safe, effective,||
1306|004|Z|or appropriate for you. This information is not individual||
1306|005|Z|medical advice and does not substitute for the advice of your||
1306|006|Z|health care professional. Always ask your health care||
1306|007|Z|professional for complete information about this product and your||
1306|008|Z|specific health needs.||
1306|009|B|||
1306|010|T|CASTOR OIL - ORAL||
1306|011|F|(KAS/tor)||
1306|012|B|||
1306|013|U|USES:  Castor oil is used to treat constipation. It may also be||
1306|014|U|used to clean out the intestines before a bowel||
1306|015|U|examination/surgery. Castor oil is known as a stimulant laxative.||
1306|016|U|It works by increasing the movement of the intestines, helping||
1306|017|U|the stool to come out.||
1306|018|B|||
1306|019|H|HOW TO USE:  Take this medication by mouth as directed by your||
1306|020|H|doctor. If you are self-treating, follow all directions on the||
1306|021|H|product package. If you have any questions, ask your doctor or||
1306|022|H|pharmacist.||
1306|023|H|   Take this medication on an empty stomach. Measure the dose||
1306|024|H|carefully using a special measuring device/cup. Do not use a||
1306|025|H|household spoon because you may not get the correct dose. You may||
1306|026|H|take this medication with juice to improve the taste.||
1306|027|H|   Dosage is based on your age, medical condition, and response||
1306|028|H|to treatment. Do not increase your dose or take this drug more||
1306|029|H|often than directed. Do not take this medication for more than 7||
1306|030|H|days unless directed by your doctor. Serious side effects may||
1306|031|H|occur with overuse of this medication (see also Side Effects||
1306|032|H|section).||
1306|033|H|   It may take 6 to 12 hours before this medication causes a||
1306|034|H|bowel movement. Tell your doctor if your condition lasts or gets||
1306|035|H|worse, or if bleeding from the rectum occurs. If you think you||
1306|036|H|may have a serious medical problem, get medical help right away.||
1306|037|B|||
1306|038|S|SIDE EFFECTS:  Stomach/abdominal pain or cramping, nausea,||
1306|039|S|diarrhea, or weakness may occur. If any of these effects last or||
1306|040|S|get worse, tell your doctor or pharmacist promptly.||
1306|041|S|   If your doctor has directed you to use this medication,||
1306|042|S|remember that your doctor has judged that the benefit to you is||
1306|043|S|greater than the risk of side effects. Many people using this||
1306|044|S|medication do not have serious side effects.||
1306|045|S|   Tell your doctor right away if you have any serious side||
1306|046|S|effects, including: nausea/vomiting/diarrhea that doesn't stop,||
1306|047|S|muscle cramps/weakness, irregular heartbeat, dizziness, decreased||
1306|048|S|urination, mental/mood changes (such as confusion).||
1306|049|S|   A very serious allergic reaction to this drug is rare.||
1306|050|S|However, get medical help right away if you notice any symptoms||
1306|051|S|of a serious allergic reaction, including: rash, itching/swelling||
1306|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1306|053|S|breathing.||
1306|054|S|   This is not a complete list of possible side effects. If you||
1306|055|S|notice other effects not listed above, contact your doctor or||
1306|056|S|pharmacist.||
1306|057|S|   In the US -||
1306|058|S|   Call your doctor for medical advice about side effects. You||
1306|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1306|060|S|www.fda.gov/medwatch.||
1306|061|S|   In Canada - Call your doctor for medical advice about side||
1306|062|S|effects. You may report side effects to Health Canada at||
1306|063|S|1-866-234-2345.||
1306|064|B|||
1306|065|P|PRECAUTIONS:  Before taking castor oil, tell your doctor or||
1306|066|P|pharmacist if you are allergic to it; or if you have any other||
1306|067|P|allergies. This product may contain inactive ingredients, which||
1306|068|P|can cause allergic reactions or other problems. Talk to your||
1306|069|P|pharmacist for more details.||
1306|070|P|   Before using this medication, tell your doctor or pharmacist||
1306|071|P|your medical history, especially of: appendicitis or symptoms of||
1306|072|P|appendicitis (such as nausea/vomiting, sudden or unexplained||
1306|073|P|stomach/abdominal pain), a sudden change in bowel habits that||
1306|074|P|lasts for longer than 2 weeks, bleeding from the rectum,||
1306|075|P|intestinal blockage.||
1306|076|P|   Before having surgery, tell your doctor or dentist about all||
1306|077|P|the products you use (including prescription drugs,||
1306|078|P|nonprescription drugs, and herbal products).||
1306|079|P|   This medication is not recommended for use during pregnancy.||
1306|080|P|Consult your doctor for more details.||
1306|081|P|   It is unknown if this medication passes into breast milk.||
1306|082|P|Consult your doctor before breastfeeding.||
1306|083|B|||
1306|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1306|085|I|medications work or increase your risk for serious side effects.||
1306|086|I|This document does not contain all possible drug interactions.||
1306|087|I|Keep a list of all the products you use (including||
1306|088|I|prescription/nonprescription drugs and herbal products) and share||
1306|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
1306|090|I|the dosage of any medicines without your doctor's approval.||
1306|091|B|||
1306|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1306|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1306|094|O|poison control center right away. US residents can call||
1306|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1306|096|O|Symptoms of overdose may include: nausea/vomiting/diarrhea that||
1306|097|O|doesn't stop, severe stomach/abdominal pain or cramping.||
1306|098|B|||
1306|099|N|NOTES:  Keep all medical and lab appointments.||
1306|100|N|   Lifestyle changes that may prevent or relieve constipation||
1306|101|N|include exercising, drinking enough water, and eating a proper||
1306|102|N|diet with fiber-rich foods such as bran, fresh fruits/vegetables.||
1306|103|N|Talk to your doctor or pharmacist about lifestyle changes that||
1306|104|N|might benefit you.||
1306|105|B|||
1306|106|D|MISSED DOSE:  If your doctor has directed you to take this||
1306|107|D|medication on a regular schedule and you miss a dose, take it as||
1306|108|D|soon as you remember. If it is near the time of the next dose,||
1306|109|D|skip the missed dose. Take your next dose at the regular time. Do||
1306|110|D|not double the dose to catch up.||
1306|111|B|||
1306|112|R|STORAGE:  Different brands of this medication have different||
1306|113|R|storage needs. Check the product package for instructions on how||
1306|114|R|to store your brand, or ask your pharmacist. Keep all medications||
1306|115|R|away from children and pets.||
1306|116|R|   Do not flush medications down the toilet or pour them into a||
1306|117|R|drain unless instructed to do so. Properly discard this product||
1306|118|R|when it is expired or no longer needed. Consult your pharmacist||
1306|119|R|or local waste disposal company.||
1306|120|B|||
1306|121|A|Information last revised May 2024.||
1306|122|A|Copyright(c) 2025 First Databank, Inc.||
1306|123|B|||
1307|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1307|002|Z|does NOT have all possible information about this product. This||
1307|003|Z|information does not assure that this product is safe, effective,||
1307|004|Z|or appropriate for you. This information is not individual||
1307|005|Z|medical advice and does not substitute for the advice of your||
1307|006|Z|health care professional. Always ask your health care||
1307|007|Z|professional for complete information about this product and your||
1307|008|Z|specific health needs.||
1307|009|B|||
1307|010|T|VELAGLUCERASE ALFA - INJECTION||
1307|011|F|(VEL-a-GLOO-ser-ase Al-fa)||
1307|012|B|||
1307|013|C|COMMON BRAND NAME(S): VPRIV||
1307|014|B|||
1307|015|W|WARNING:  Velaglucerase alfa may cause serious (sometimes fatal)||
1307|016|W|allergic reactions. Get medical help right away if you have any||
1307|017|W|symptoms of a serious allergic reaction such as rash,||
1307|018|W|itching/swelling (especially of the face/tongue/throat), severe||
1307|019|W|dizziness, trouble breathing, fainting, or high fever.||
1307|020|B|||
1307|021|U|USES:  Velaglucerase alfa is used to treat a certain rare genetic||
1307|022|U|problem (Gaucher disease). Velaglucerase alfa replaces a certain||
1307|023|U|natural substance (an enzyme called glucocerebrosidase) that is||
1307|024|U|missing in people with Gaucher disease.||
1307|025|U|   This medication improves blood, bone, liver, and spleen||
1307|026|U|problems caused by Gaucher disease. Velaglucerase alfa does not||
1307|027|U|correct the genetic problem, and treatment must be continued for||
1307|028|U|life.||
1307|029|B|||
1307|030|H|HOW TO USE:  This medication is given by injection into a vein by||
1307|031|H|a health care professional. It is given as directed by your||
1307|032|H|doctor, usually once every 2 weeks. It is injected slowly into a||
1307|033|H|vein over 1 hour. The dosage and treatment schedule are based on||
1307|034|H|your medical condition, weight, and response to treatment.||
1307|035|H|   Tell your doctor if your condition lasts or gets worse. Blood,||
1307|036|H|liver, and spleen problems usually improve in the first year of||
1307|037|H|treatment. It may take 2 to 3 years of treatment to see the full||
1307|038|H|benefit to your bones.||
1307|039|B|||
1307|040|S|SIDE EFFECTS:  See also Warning section.||
1307|041|S|   Fever, headache, nausea, dizziness, abdominal pain, back/joint||
1307|042|S|pain, weakness, tiredness, or redness/pain/itching/swelling at||
1307|043|S|the injection site may occur. If any of these effects last or get||
1307|044|S|worse, tell your doctor or pharmacist promptly.||
1307|045|S|   Remember that this medication has been prescribed because your||
1307|046|S|doctor has judged that the benefit to you is greater than the||
1307|047|S|risk of side effects. Many people using this medication do not||
1307|048|S|have serious side effects.||
1307|049|S|   This is not a complete list of possible side effects. If you||
1307|050|S|notice other effects not listed above, contact your doctor or||
1307|051|S|pharmacist.||
1307|052|S|   In the US -||
1307|053|S|   Call your doctor for medical advice about side effects. You||
1307|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1307|055|S|www.fda.gov/medwatch.||
1307|056|S|   In Canada - Call your doctor for medical advice about side||
1307|057|S|effects. You may report side effects to Health Canada at||
1307|058|S|1-866-234-2345.||
1307|059|B|||
1307|060|P|PRECAUTIONS:  Before using velaglucerase alfa, tell your doctor||
1307|061|P|or pharmacist if you are allergic to it; or to alglucerase; or if||
1307|062|P|you have any other allergies. This product may contain inactive||
1307|063|P|ingredients, which can cause allergic reactions or other||
1307|064|P|problems. Talk to your pharmacist for more details.||
1307|065|P|   Before using this medication, tell your doctor or pharmacist||
1307|066|P|your medical history.||
1307|067|P|   Before having surgery, tell your doctor or dentist about all||
1307|068|P|the products you use (including prescription drugs,||
1307|069|P|nonprescription drugs, and herbal products).||
1307|070|P|   During pregnancy, this medication should be used only when||
1307|071|P|clearly needed. Discuss the risks and benefits with your doctor.||
1307|072|P|   It is unknown if this medication passes into breast milk.||
1307|073|P|Consult your doctor before breastfeeding.||
1307|074|B|||
1307|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1307|076|I|medications work or increase your risk for serious side effects.||
1307|077|I|This document does not contain all possible drug interactions.||
1307|078|I|Keep a list of all the products you use (including||
1307|079|I|prescription/nonprescription drugs and herbal products) and share||
1307|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
1307|081|I|the dosage of any medicines without your doctor's approval.||
1307|082|B|||
1307|083|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1307|084|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1307|085|O|poison control center right away. US residents can call||
1307|086|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1307|087|B|||
1307|088|N|NOTES:  Lab and/or medical tests (such as IgG antibodies) should||
1307|089|N|be done while you are using this medication. Keep all medical and||
1307|090|N|lab appointments. Consult your doctor for more details.||
1307|091|B|||
1307|092|D|MISSED DOSE:  It is important to get each dose of this medication||
1307|093|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1307|094|D|right away for a new dosing schedule.||
1307|095|B|||
1307|096|R|STORAGE:  Not applicable. This medication is given in a hospital||
1307|097|R|or clinic or doctor's office and will not be stored at home.||
1307|098|B|||
1307|099|A|Information last revised July 2024.||
1307|100|A|Copyright(c) 2025 First Databank, Inc.||
1307|101|B|||
1308|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1308|002|Z|does NOT have all possible information about this product. This||
1308|003|Z|information does not assure that this product is safe, effective,||
1308|004|Z|or appropriate for you. This information is not individual||
1308|005|Z|medical advice and does not substitute for the advice of your||
1308|006|Z|health care professional. Always ask your health care||
1308|007|Z|professional for complete information about this product and your||
1308|008|Z|specific health needs.||
1308|009|B|||
1308|010|T|ROMIDEPSIN - INJECTION||
1308|011|F|(ROE-mi-DEP-sin)||
1308|012|B|||
1308|013|C|COMMON BRAND NAME(S): Istodax||
1308|014|B|||
1308|015|U|USES:  Romidepsin is used to treat a certain type of cancer||
1308|016|U|(cutaneous T-cell lymphoma). Romidepsin works by stopping the||
1308|017|U|growth of cancer cells.||
1308|018|B|||
1308|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1308|020|H|from your pharmacist before your first romidepsin treatment and||
1308|021|H|each time you get another dose. If you have any questions, ask||
1308|022|H|your doctor or pharmacist.||
1308|023|H|   This medication is given by injection into a vein by a health||
1308|024|H|care professional. It is given as directed by your doctor,||
1308|025|H|usually over 4 hours on days 1, 8, and 15 of a 28-day treatment||
1308|026|H|cycle. This cycle is then repeated as directed by your doctor.||
1308|027|H|   The dosage is based on your medical condition, body size, and||
1308|028|H|response to treatment.||
1308|029|H|   Use this medication regularly to get the most benefit from it.||
1308|030|H|To help you remember, mark your calendar with a reminder.||
1308|031|B|||
1308|032|S|SIDE EFFECTS:  Nausea, vomiting, tiredness, and loss of appetite||
1308|033|S|may occur. If any of these effects last or get worse, tell your||
1308|034|S|doctor or pharmacist promptly.||
1308|035|S|   People using this medication may have serious side effects.||
1308|036|S|However, you have been prescribed this drug because your doctor||
1308|037|S|has judged that the benefit to you is greater than the risk of||
1308|038|S|side effects. Careful monitoring by your doctor may decrease your||
1308|039|S|risk.||
1308|040|S|   This medication decreases bone marrow function, an effect that||
1308|041|S|may lead to a low number of blood cells such as red cells, white||
1308|042|S|cells, and platelets. This effect can cause anemia, decrease your||
1308|043|S|body's ability to fight an infection, or cause easy||
1308|044|S|bruising/bleeding. It may make you more likely to get a serious||
1308|045|S|(rarely fatal) infection or make any infection you have worse.||
1308|046|S|Tell your doctor right away if you develop any of the following||
1308|047|S|symptoms: unusual tiredness, pale skin, signs of infection (such||
1308|048|S|as sore throat that doesn't go away, fever, chills), easy||
1308|049|S|bruising/bleeding.||
1308|050|S|   Get medical help right away if you have any very serious side||
1308|051|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1308|052|S|dizziness, fainting.||
1308|053|S|   Romidepsin sometimes causes side effects due to the rapid||
1308|054|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1308|055|S|risk, your doctor may add a medication and tell you to drink||
1308|056|S|plenty of fluids. Tell your doctor right away if you have||
1308|057|S|symptoms such as: low back/side pain (flank pain), signs of||
1308|058|S|kidney problems (such as painful urination, pink/bloody urine,||
1308|059|S|change in the amount of urine), muscle spasms/weakness.||
1308|060|S|   A very serious allergic reaction to this drug is rare.||
1308|061|S|However, get medical help right away if you notice any symptoms||
1308|062|S|of a serious allergic reaction, including: rash, itching/swelling||
1308|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1308|064|S|breathing.||
1308|065|S|   This is not a complete list of possible side effects. If you||
1308|066|S|notice other effects not listed above, contact your doctor or||
1308|067|S|pharmacist.||
1308|068|S|   In the US -||
1308|069|S|   Call your doctor for medical advice about side effects. You||
1308|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1308|071|S|www.fda.gov/medwatch.||
1308|072|S|   In Canada - Call your doctor for medical advice about side||
1308|073|S|effects. You may report side effects to Health Canada at||
1308|074|S|1-866-234-2345.||
1308|075|B|||
1308|076|P|PRECAUTIONS:  Before receiving this medication, tell your doctor||
1308|077|P|or pharmacist if you are allergic to it; or if you have any other||
1308|078|P|allergies. This product may contain inactive ingredients, which||
1308|079|P|can cause allergic reactions or other problems. Talk to your||
1308|080|P|pharmacist for more details.||
1308|081|P|   Before using this medication, tell your doctor or pharmacist||
1308|082|P|your medical history, especially of: liver disease (such as||
1308|083|P|hepatitis B), heart disease (such as chest pain, heart attack),||
1308|084|P|current/recent infection.||
1308|085|P|   Romidepsin may cause a condition that affects the heart rhythm||
1308|086|P|(QT prolongation). QT prolongation can rarely cause serious||
1308|087|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1308|088|P|as severe dizziness, fainting) that need medical attention right||
1308|089|P|away.||
1308|090|P|   The risk of QT prolongation may be increased if you have||
1308|091|P|certain medical conditions or are taking other drugs that may||
1308|092|P|cause QT prolongation. Before using romidepsin, tell your doctor||
1308|093|P|or pharmacist of all the drugs you take and if you have any of||
1308|094|P|the following conditions: certain heart problems (heart failure,||
1308|095|P|slow heartbeat, QT prolongation in the EKG), family history of||
1308|096|P|certain heart problems (QT prolongation in the EKG, sudden||
1308|097|P|cardiac death).||
1308|098|P|   Low levels of potassium or magnesium in the blood may also||
1308|099|P|increase your risk of QT prolongation. This risk may increase if||
1308|100|P|you use certain drugs (such as diuretics/"water pills") or if you||
1308|101|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1308|102|P|Talk to your doctor about using romidepsin safely.||
1308|103|P|   Before having surgery, tell your doctor or dentist about all||
1308|104|P|the products you use (including prescription drugs,||
1308|105|P|nonprescription drugs, and herbal products).||
1308|106|P|   Romidepsin can make you more likely to get infections or may||
1308|107|P|make current infections worse. Stay away from anyone who has an||
1308|108|P|infection that may easily spread (such as chickenpox, COVID-19,||
1308|109|P|measles, flu). Talk to your doctor if you have been exposed to an||
1308|110|P|infection or for more details.||
1308|111|P|   Tell your health care professional that you are using||
1308|112|P|romidepsin before having any immunizations/vaccinations. Avoid||
1308|113|P|contact with people who have recently received live vaccines||
1308|114|P|(such as flu vaccine inhaled through the nose).||
1308|115|P|   To lower the chance of getting cut, bruised, or injured, use||
1308|116|P|caution with sharp objects like razors and nail cutters, and||
1308|117|P|avoid activities such as contact sports.||
1308|118|P|   Older adults may be more sensitive to the side effects of this||
1308|119|P|drug, especially QT prolongation (see above).||
1308|120|P|   Tell your doctor if you are pregnant or plan to become||
1308|121|P|pregnant. You should not become pregnant while using romidepsin.||
1308|122|P|Romidepsin may harm an unborn baby. Your doctor should order a||
1308|123|P|pregnancy test within 7 days before you start this medication.||
1308|124|P|Men and women using this medication should ask about reliable||
1308|125|P|forms of birth control during treatment and for 1 month after the||
1308|126|P|last dose. If you or your partner becomes pregnant, talk to your||
1308|127|P|doctor right away about the risks and benefits of this||
1308|128|P|medication. See also Drug Interactions section.||
1308|129|P|   It is unknown if this medication passes into breast milk.||
1308|130|P|Because of the possible risk to the infant, breastfeeding is not||
1308|131|P|recommended while using this medication and for 1 week after the||
1308|132|P|last dose. Consult your doctor before breastfeeding.||
1308|133|B|||
1308|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1308|135|I|medications work or increase your risk for serious side effects.||
1308|136|I|This document does not contain all possible drug interactions.||
1308|137|I|Keep a list of all the products you use (including||
1308|138|I|prescription/nonprescription drugs and herbal products) and share||
1308|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
1308|140|I|the dosage of any medicines without your doctor's approval.||
1308|141|I|   Some products that may interact with this drug include:||
1308|142|I|disulfiram, "blood thinners" (such as warfarin).||
1308|143|I|   Other medications can affect the removal of romidepsin from||
1308|144|I|your body, thereby affecting how romidepsin works. These drugs||
1308|145|I|include azole antifungals (such as itraconazole, ketoconazole),||
1308|146|I|dexamethasone, macrolide antibiotics (such as clarithromycin),||
1308|147|I|nefazodone, rifamycins (such as rifabutin, rifampin), St. John's||
1308|148|I|wort, and some drugs used to treat seizures (such as||
1308|149|I|carbamazepine), among others.||
1308|150|I|   This medication may decrease the effectiveness of hormonal||
1308|151|I|birth control such as pills, patch, or ring. This could cause||
1308|152|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1308|153|I|use reliable backup birth control methods while using this||
1308|154|I|medication and for 1 month after the last dose. Also tell your||
1308|155|I|doctor if you have any new spotting or breakthrough bleeding,||
1308|156|I|because these may be signs that your birth control is not working||
1308|157|I|well.||
1308|158|B|||
1308|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1308|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1308|161|O|poison control center right away. US residents can call||
1308|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1308|163|B|||
1308|164|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1308|165|N|potassium/magnesium blood levels, EKG, liver function) should be||
1308|166|N|done while you are using this medication. Keep all medical and||
1308|167|N|lab appointments.||
1308|168|B|||
1308|169|D|MISSED DOSE:  It is important to get each dose of this medication||
1308|170|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1308|171|D|right away for a new dosing schedule.||
1308|172|B|||
1308|173|R|STORAGE:  Not applicable. This medication is given in a hospital||
1308|174|R|or clinic and will not be stored at home.||
1308|175|B|||
1308|176|M|MEDICAL ALERT:  Your condition can cause complications in a||
1308|177|M|medical emergency. For information about enrolling in MedicAlert,||
1308|178|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1308|179|B|||
1308|180|A|Information last revised April 2025.||
1308|181|A|Copyright(c) 2025 First Databank, Inc.||
1308|182|B|||
1309|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1309|002|Z|does NOT have all possible information about this product. This||
1309|003|Z|information does not assure that this product is safe, effective,||
1309|004|Z|or appropriate for you. This information is not individual||
1309|005|Z|medical advice and does not substitute for the advice of your||
1309|006|Z|health care professional. Always ask your health care||
1309|007|Z|professional for complete information about this product and your||
1309|008|Z|specific health needs.||
1309|009|B|||
1309|010|T|HYDROMORPHONE EXTENDED-RELEASE - ORAL||
1309|011|F|(hye-droe-MOR-fone)||
1309|012|B|||
1309|013|C|COMMON BRAND NAME(S): Exalgo||
1309|014|B|||
1309|015|W|WARNING:  Hydromorphone has a risk for abuse and addiction, which||
1309|016|W|can lead to overdose and death. Hydromorphone may also cause||
1309|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
1309|018|W|your doctor should have you take the smallest dose of||
1309|019|W|hydromorphone that works, and take it for the shortest possible||
1309|020|W|time. See also How to Use section for more information about||
1309|021|W|addiction.||
1309|022|W|   Ask your doctor or pharmacist if you should have medication||
1309|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1309|024|W|Teach your family or household members about the signs of an||
1309|025|W|opioid overdose and how to treat it.||
1309|026|W|   The risk for severe breathing problems is higher when you||
1309|027|W|start this medication and after a dose increase, or if you take||
1309|028|W|the wrong dose/strength. Taking this medication with alcohol or||
1309|029|W|other drugs that can cause drowsiness or breathing problems may||
1309|030|W|cause very serious side effects, including death. Be sure you||
1309|031|W|know how to take hydromorphone and what other drugs you should||
1309|032|W|avoid taking with it. See also Drug Interactions section. Get||
1309|033|W|medical help right away if any of these very serious side effects||
1309|034|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
1309|035|W|drowsiness/dizziness, difficulty waking up.||
1309|036|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1309|037|W|or abuse. If someone accidentally swallows this drug, get medical||
1309|038|W|help right away.||
1309|039|W|   Before using this medication, women of childbearing age should||
1309|040|W|talk with their doctor(s) about the risks and benefits. Tell your||
1309|041|W|doctor if you are pregnant or if you plan to become pregnant.||
1309|042|W|During pregnancy, this medication should be used only when||
1309|043|W|clearly needed. It may slightly increase the risk of birth||
1309|044|W|defects if used during the first two months of pregnancy. Also,||
1309|045|W|using it for a long time or in high doses near the expected||
1309|046|W|delivery date may harm the unborn baby. To lessen the risk, take||
1309|047|W|the smallest effective dose for the shortest possible time.||
1309|048|W|Babies born to mothers who use this drug for a long time may||
1309|049|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1309|050|W|doctor right away if you notice any symptoms in your newborn baby||
1309|051|W|such as crying that doesn't stop, slow/shallow breathing,||
1309|052|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1309|053|W|difficulty gaining weight.||
1309|054|W|   Hydromorphone extended-release should be used only if you have||
1309|055|W|been regularly taking moderate to large amounts of opioid pain||
1309|056|W|medication. This medication may cause overdose (even death) if||
1309|057|W|taken by a person who has not been regularly taking opioids.||
1309|058|W|   This product is designed to slowly release hydromorphone. Do||
1309|059|W|not break, crush, dissolve, or chew this medication. Taking||
1309|060|W|broken, crushed, dissolved, or chewed forms of extended-release||
1309|061|W|hydromorphone could cause a fatal overdose.||
1309|062|B|||
1309|063|U|USES:  See also Warning section.||
1309|064|U|   This medication contains hydromorphone in a long-acting form.||
1309|065|U|It is used to help relieve severe ongoing pain (such as due to||
1309|066|U|cancer). Hydromorphone belongs to a class of drugs known as||
1309|067|U|opioid analgesics. It works in the brain to change how your body||
1309|068|U|feels and responds to pain.||
1309|069|U|   Do not use the extended-release form of hydromorphone to||
1309|070|U|relieve pain that is mild or that will go away in a few days.||
1309|071|U|This medication is not for occasional ("as needed") use.||
1309|072|B|||
1309|073|H|HOW TO USE:  See also Warning section.||
1309|074|H|   Read the Medication Guide and, if available, the Patient||
1309|075|H|Information Leaflet provided by your pharmacist before you start||
1309|076|H|taking this product and each time you get a refill. If you have||
1309|077|H|any questions , ask your doctor or pharmacist.||
1309|078|H|   Take this medication by mouth as directed by your doctor,||
1309|079|H|usually once daily at the same time each day, not as needed for||
1309|080|H|sudden (breakthrough) pain. You may take this drug with or||
1309|081|H|without food. If you have nausea, it may help to take this drug||
1309|082|H|with food. Ask your doctor or pharmacist about other ways to||
1309|083|H|decrease nausea (such as lying down for 1 to 2 hours with as||
1309|084|H|little head movement as possible).||
1309|085|H|   Swallow the tablet whole. Do not crush, break, chew, or||
1309|086|H|dissolve the tablet. Doing so can release all of the drug at||
1309|087|H|once, increasing the risk of side effects.||
1309|088|H|   Hydromorphone comes in a rapid-acting form and a slow-release||
1309|089|H|form. Check with your pharmacist to make sure you are taking the||
1309|090|H|correct form.||
1309|091|H|   The dosage is based on your medical condition and response to||
1309|092|H|treatment. Do not increase your dose, take the medication more||
1309|093|H|often, or take it for a longer time than prescribed. Properly||
1309|094|H|stop the medication when so directed. If you do not take this||
1309|095|H|medication for 3 days in a row, call your doctor before||
1309|096|H|restarting the medication. Your restarting dose may need to be||
1309|097|H|lower.||
1309|098|H|   Before you start using this medication, ask your doctor or||
1309|099|H|pharmacist if you should stop or change how you use your other||
1309|100|H|opioid medication(s). Other pain relievers (such as||
1309|101|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1309|102|H|or pharmacist about using hydromorphone safely with other drugs.||
1309|103|H|   Suddenly stopping this medication may cause withdrawal,||
1309|104|H|especially if you have used it for a long time or in high doses.||
1309|105|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1309|106|H|Tell your doctor or pharmacist right away if you have any||
1309|107|H|withdrawal symptoms such as restlessness, mental/mood changes||
1309|108|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1309|109|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1309|110|H|aches, or sudden changes in behavior.||
1309|111|H|   When this medication is used for a long time, it may not work||
1309|112|H|as well. Talk with your doctor if this medication stops working||
1309|113|H|well.||
1309|114|H|   Though it helps many people, this medication may sometimes||
1309|115|H|cause addiction. This risk may be higher if you have a||
1309|116|H|mental/mood disorder or a substance use disorder (such as overuse||
1309|117|H|of or addiction to drugs/alcohol). Take this medication exactly||
1309|118|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1309|119|H|pharmacist for more details.||
1309|120|H|   Tell your doctor if your pain does not get better or if it||
1309|121|H|gets worse, or if you have any new pain.||
1309|122|B|||
1309|123|S|SIDE EFFECTS:  See also Warning section.||
1309|124|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
1309|125|S|drowsiness may occur. Some of these side effects may decrease||
1309|126|S|after you have been using this medication for a while. If any of||
1309|127|S|these effects last or get worse, tell your doctor or pharmacist||
1309|128|S|promptly.||
1309|129|S|   To prevent constipation, eat dietary fiber, drink enough||
1309|130|S|water, and exercise. You may also need to take a laxative. Ask||
1309|131|S|your pharmacist which type of laxative is right for you.||
1309|132|S|   To reduce the risk of dizziness and lightheadedness, get up||
1309|133|S|slowly when rising from a sitting or lying position.||
1309|134|S|   You may notice an empty tablet shell in your stool. This is||
1309|135|S|harmless because your body has already absorbed the medicine.||
1309|136|S|   Remember that this medication has been prescribed because your||
1309|137|S|doctor has judged that the benefit to you is greater than the||
1309|138|S|risk of side effects. Many people using this medication do not||
1309|139|S|have serious side effects.||
1309|140|S|   Tell your doctor right away if you have any serious side||
1309|141|S|effects, including: interrupted breathing during sleep (sleep||
1309|142|S|apnea), mental/mood changes (such as agitation, hallucinations,||
1309|143|S|confusion), severe stomach/abdominal pain, difficulty urinating,||
1309|144|S|signs of your adrenal glands not working well (such as loss of||
1309|145|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
1309|146|S|   Get medical help right away if you have any very serious side||
1309|147|S|effects, including: fainting, slow/shallow breathing, severe||
1309|148|S|drowsiness/difficulty waking up, seizures.||
1309|149|S|   A very serious allergic reaction to this drug is rare.||
1309|150|S|However, get medical help right away if you notice any symptoms||
1309|151|S|of a serious allergic reaction, including: rash, itching/swelling||
1309|152|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1309|153|S|breathing.||
1309|154|S|   This is not a complete list of possible side effects. If you||
1309|155|S|notice other effects not listed above, contact your doctor or||
1309|156|S|pharmacist.||
1309|157|S|   In the US -||
1309|158|S|   Call your doctor for medical advice about side effects. You||
1309|159|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1309|160|S|www.fda.gov/medwatch.||
1309|161|S|   In Canada - Call your doctor for medical advice about side||
1309|162|S|effects. You may report side effects to Health Canada at||
1309|163|S|1-866-234-2345.||
1309|164|B|||
1309|165|P|PRECAUTIONS:  Before taking hydromorphone, tell your doctor or||
1309|166|P|pharmacist if you are allergic to hydromorphone; or to other||
1309|167|P|opioid pain medications (such as hydrocodone, morphine); or if||
1309|168|P|you have any other allergies. This product may contain inactive||
1309|169|P|ingredients (such as sulfites), which can cause allergic||
1309|170|P|reactions or other problems. Talk to your pharmacist for more||
1309|171|P|details.||
1309|172|P|   Before using this medication, tell your doctor or pharmacist||
1309|173|P|your medical history, especially of: brain disorders (such as||
1309|174|P|head injury, tumor, seizures), breathing problems (such as||
1309|175|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1309|176|P|kidney disease, liver disease, mental/mood disorders (such as||
1309|177|P|confusion, depression), personal or family history of a substance||
1309|178|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
1309|179|P|stomach/intestinal problems (such as blockage, stomach or bypass||
1309|180|P|surgery, constipation, diarrhea due to infection, paralytic||
1309|181|P|ileus), difficulty swallowing, difficulty urinating (such as due||
1309|182|P|to enlarged prostate), disease of the pancreas (pancreatitis),||
1309|183|P|gallbladder disease.||
1309|184|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1309|185|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1309|186|P|machinery, or do anything that needs alertness until you can do||
1309|187|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1309|188|P|are using marijuana (cannabis).||
1309|189|P|   Before having surgery, tell your doctor or dentist about all||
1309|190|P|the products you use (including prescription drugs,||
1309|191|P|nonprescription drugs, and herbal products).||
1309|192|P|   Older adults may be more sensitive to the side effects of this||
1309|193|P|drug, especially confusion, dizziness, drowsiness, and||
1309|194|P|slow/shallow breathing.||
1309|195|P|   During pregnancy, this medication should be used only when||
1309|196|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1309|197|P|benefits with your doctor. (See also Warning section.)||
1309|198|P|   This drug passes into breast milk and may have undesirable||
1309|199|P|effects on a nursing infant. Tell the doctor right away if your||
1309|200|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1309|201|P|breathing. Consult your doctor before breastfeeding.||
1309|202|B|||
1309|203|I|DRUG INTERACTIONS:  See also Warning section.||
1309|204|I|   Drug interactions may change how your medications work or||
1309|205|I|increase your risk for serious side effects. This document does||
1309|206|I|not contain all possible drug interactions. Keep a list of all||
1309|207|I|the products you use (including prescription/nonprescription||
1309|208|I|drugs and herbal products) and share it with your doctor and||
1309|209|I|pharmacist. Do not start, stop, or change the dosage of any||
1309|210|I|medicines without your doctor's approval.||
1309|211|I|   Some products that may interact with this drug include:||
1309|212|I|certain pain medications (mixed opioid agonist-antagonists such||
1309|213|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1309|214|I|samidorphan.||
1309|215|I|   The risk of serious side effects (such as slow/shallow||
1309|216|I|breathing, severe drowsiness/dizziness) may be increased if this||
1309|217|I|medication is taken with other products that may also cause||
1309|218|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1309|219|I|if you are taking other products such as other opioid pain or||
1309|220|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1309|221|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1309|222|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1309|223|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1309|224|I|cetirizine, diphenhydramine).||
1309|225|I|   Check the labels on all your medicines (such as allergy or||
1309|226|I|cough-and-cold products) because they may contain ingredients||
1309|227|I|that cause drowsiness. Ask your pharmacist about using those||
1309|228|I|products safely.||
1309|229|I|   This medication may interfere with certain lab tests (such as||
1309|230|I|amylase/lipase levels), possibly causing false test results. Make||
1309|231|I|sure lab personnel and all your doctors know you use this drug.||
1309|232|B|||
1309|233|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1309|234|O|as passing out or trouble breathing, give them naloxone or||
1309|235|O|nalmefene if available, then call 911. If the person is awake and||
1309|236|O|has no symptoms, call a poison control center right away. US||
1309|237|O|residents can call 1-800-222-1222. Canada residents can call||
1309|238|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1309|239|O|breathing, slow heartbeat, coma.||
1309|240|B|||
1309|241|N|NOTES:  Do not share this medication with others. Sharing it is||
1309|242|N|against the law.||
1309|243|N|   This medication has been prescribed for your current condition||
1309|244|N|only. Do not use it later for another condition unless told to do||
1309|245|N|so by your doctor. A different medication may be necessary in||
1309|246|N|that case.||
1309|247|B|||
1309|248|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1309|249|D|next dose at the regular time. Do not double the dose to catch||
1309|250|D|up. Do not take 2 doses in 24 hours.||
1309|251|B|||
1309|252|R|STORAGE:  Store at room temperature away from light and moisture.||
1309|253|R|Do not store in the bathroom. Keep all medications away from||
1309|254|R|children and pets. See also Warning section.||
1309|255|R|   Do not flush medications down the toilet or pour them into a||
1309|256|R|drain unless instructed to do so. Properly discard this product||
1309|257|R|when it is expired or no longer needed. For more details, read||
1309|258|R|the Medication Guide, or consult your pharmacist or local waste||
1309|259|R|disposal company.||
1309|260|B|||
1309|261|A|Information last revised August 2025.||
1309|262|A|Copyright(c) 2025 First Databank, Inc.||
1309|263|B|||
1310|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1310|002|Z|does NOT have all possible information about this product. This||
1310|003|Z|information does not assure that this product is safe, effective,||
1310|004|Z|or appropriate for you. This information is not individual||
1310|005|Z|medical advice and does not substitute for the advice of your||
1310|006|Z|health care professional. Always ask your health care||
1310|007|Z|professional for complete information about this product and your||
1310|008|Z|specific health needs.||
1310|009|B|||
1310|010|T|TRIPTORELIN 6 MONTH (22.5 MG) - INJECTION||
1310|011|F|(trip-toe-REL-in)||
1310|012|B|||
1310|013|C|COMMON BRAND NAME(S): Trelstar||
1310|014|B|||
1310|015|U|USES:  Triptorelin is used to treat advanced prostate cancer. It||
1310|016|U|is not a cure. Most types of prostate cancer need the hormone||
1310|017|U|testosterone to grow and spread. Triptorelin works by reducing||
1310|018|U|the amount of testosterone that the body makes. This effect helps||
1310|019|U|slow or stop the growth of cancer cells and helps relieve||
1310|020|U|symptoms such as painful/difficult urination. This medication is||
1310|021|U|similar to a natural substance made by the body (luteinizing||
1310|022|U|hormone releasing hormone-LHRH). Talk to your doctor about the||
1310|023|U|risks and benefits of treatment.||
1310|024|B|||
1310|025|V|OTHER USES:  This section contains uses of this drug that are not||
1310|026|V|listed in the approved professional labeling for the drug but||
1310|027|V|that may be prescribed by your health care professional. Use this||
1310|028|V|drug for a condition that is listed in this section only if it||
1310|029|V|has been so prescribed by your health care professional.||
1310|030|V|   This drug may also be used for a certain disorder of the||
1310|031|V|uterus (endometriosis). Triptorelin may also be used to stop||
1310|032|V|early puberty in children.||
1310|033|B|||
1310|034|H|HOW TO USE:  This medication is given as an injection into the||
1310|035|H|muscle of your buttocks by a health care professional. It is||
1310|036|H|given as directed by your doctor, usually once every 6 months.||
1310|037|H|   Follow the dosing schedule carefully to get the most benefit||
1310|038|H|from this drug. To help you remember, mark your calendar with a||
1310|039|H|reminder.||
1310|040|H|   During the first few weeks of treatment, your testosterone||
1310|041|H|level will actually increase before it decreases. This is a||
1310|042|H|normal response by your body to this drug. This effect may result||
1310|043|H|in new or worsening symptoms for the first few weeks. If you have||
1310|044|H|prostate cancer that has spread to the spine or that has caused||
1310|045|H|urinary blockage, you may require closer monitoring by your||
1310|046|H|doctor, especially when you first start treatment. Tell your||
1310|047|H|doctor right away if you experience any of the following serious||
1310|048|H|side effects: bone pain, numbness/tingling/weakness of the||
1310|049|H|arms/legs, blood in the urine, painful/difficult urination.||
1310|050|H|   Tell your doctor if your condition does not get better or if||
1310|051|H|it gets worse.||
1310|052|B|||
1310|053|S|SIDE EFFECTS:  See also the How to Use section.||
1310|054|S|   Hot flashes (flushing), decreased sexual interest/ability,||
1310|055|S|shrinking of the testicles, and breast tenderness/swelling may||
1310|056|S|occur as a result of lowered testosterone levels. Dizziness and||
1310|057|S|headache may also occur with this drug. If any of these effects||
1310|058|S|bother you, tell your doctor or pharmacist promptly.||
1310|059|S|   Remember that this medication has been prescribed because your||
1310|060|S|doctor has judged that the benefit to you is greater than the||
1310|061|S|risk of side effects. Many people using this medication do not||
1310|062|S|have serious side effects.||
1310|063|S|   Tell your doctor right away if you have any serious side||
1310|064|S|effects, including: bone/joint/unusual pain, easily broken bones,||
1310|065|S|swelling of the ankles/feet, unusual weakness, inability to move||
1310|066|S|(paralysis), increased thirst, increased urination, mental/mood||
1310|067|S|changes (such as depression), signs of liver disease (such as||
1310|068|S|nausea/vomiting that doesn't stop, loss of appetite,||
1310|069|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1310|070|S|   Get medical help right away if you have any very serious side||
1310|071|S|effects, including: chest/jaw/left arm pain, fast/irregular||
1310|072|S|heartbeat, severe dizziness, fainting, weakness on one side of||
1310|073|S|the body, trouble speaking, seizures.||
1310|074|S|   A very serious allergic reaction to this drug is rare.||
1310|075|S|However, get medical help right away if you notice any symptoms||
1310|076|S|of a serious allergic reaction, including: fever, swollen lymph||
1310|077|S|nodes, rash, itching/swelling (especially of the||
1310|078|S|face/tongue/throat), severe dizziness, trouble breathing.||
1310|079|S|   This is not a complete list of possible side effects. If you||
1310|080|S|notice other effects not listed above, contact your doctor or||
1310|081|S|pharmacist.||
1310|082|S|   In the US -||
1310|083|S|   Call your doctor for medical advice about side effects. You||
1310|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1310|085|S|www.fda.gov/medwatch.||
1310|086|S|   In Canada - Call your doctor for medical advice about side||
1310|087|S|effects. You may report side effects to Health Canada at||
1310|088|S|1-866-234-2345.||
1310|089|B|||
1310|090|P|PRECAUTIONS:  Before using triptorelin, tell your doctor or||
1310|091|P|pharmacist if you are allergic to it; or to other LHRH-type drugs||
1310|092|P|(such as leuprolide); or if you have any other allergies. This||
1310|093|P|product may contain inactive ingredients, which can cause||
1310|094|P|allergic reactions or other problems. Talk to your pharmacist for||
1310|095|P|more details.||
1310|096|P|   Before using this medication, tell your doctor or pharmacist||
1310|097|P|your medical history, especially of: kidney disease, liver||
1310|098|P|disease, personal or family history of weak/broken bones||
1310|099|P|(osteoporosis), diabetes, heart disease (such as heart attack),||
1310|100|P|stroke, high cholesterol, mental/mood problems (such as||
1310|101|P|depression), seizures.||
1310|102|P|   Triptorelin may cause a condition that affects the heart||
1310|103|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1310|104|P|serious (rarely fatal) fast/irregular heartbeat and other||
1310|105|P|symptoms (such as severe dizziness, fainting) that need medical||
1310|106|P|attention right away.||
1310|107|P|   The risk of QT prolongation may be increased if you have||
1310|108|P|certain medical conditions or are taking other drugs that may||
1310|109|P|cause QT prolongation. Before using triptorelin, tell your doctor||
1310|110|P|or pharmacist of all the drugs you take and if you have any of||
1310|111|P|the following conditions: certain heart problems (heart failure,||
1310|112|P|slow heartbeat, QT prolongation in the EKG), family history of||
1310|113|P|certain heart problems (QT prolongation in the EKG, sudden||
1310|114|P|cardiac death).||
1310|115|P|   Low levels of potassium or magnesium in the blood may also||
1310|116|P|increase your risk of QT prolongation. This risk may increase if||
1310|117|P|you use certain drugs (such as diuretics/"water pills") or if you||
1310|118|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1310|119|P|Talk to your doctor about using triptorelin safely.||
1310|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1310|121|P|can make you more dizzy. Do not drive, use machinery, or do||
1310|122|P|anything that needs alertness until you can do it safely. Limit||
1310|123|P|alcoholic beverages. Talk to your doctor if you are using||
1310|124|P|marijuana (cannabis).||
1310|125|P|   Older adults may be more sensitive to the side effects of this||
1310|126|P|drug, especially QT prolongation (see above).||
1310|127|P|   Females: Triptorelin is not usually used by women. It must not||
1310|128|P|be used by pregnant women because it may harm an unborn baby. If||
1310|129|P|you become pregnant or think you may be pregnant, tell your||
1310|130|P|doctor right away. Breastfeeding is also not recommended during||
1310|131|P|triptorelin treatment. Consult your doctor for more details and||
1310|132|P|before breastfeeding, and to discuss reliable forms of birth||
1310|133|P|control.||
1310|134|B|||
1310|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1310|136|I|medications work or increase your risk for serious side effects.||
1310|137|I|This document does not contain all possible drug interactions.||
1310|138|I|Keep a list of all the products you use (including||
1310|139|I|prescription/nonprescription drugs and herbal products) and share||
1310|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
1310|141|I|the dosage of any medicines without your doctor's approval.||
1310|142|B|||
1310|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1310|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1310|145|O|poison control center right away. US residents can call||
1310|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1310|147|B|||
1310|148|N|NOTES:  Lab and/or medical tests (such as testosterone blood||
1310|149|N|levels, PSA blood tests, blood glucose, cholesterol/triglyceride||
1310|150|N|levels) should be done while you are using this medication. Keep||
1310|151|N|all medical and lab appointments. Consult your doctor for more||
1310|152|N|details.||
1310|153|B|||
1310|154|D|MISSED DOSE:  It is important to get each dose of this medication||
1310|155|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1310|156|D|right away for a new dosing schedule.||
1310|157|B|||
1310|158|R|STORAGE:  Not applicable. This medication is given in a doctor's||
1310|159|R|office and will not be stored at home.||
1310|160|B|||
1310|161|A|Information last revised September 2025.||
1310|162|A|Copyright(c) 2025 First Databank, Inc.||
1310|163|B|||
1311|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1311|002|Z|does NOT have all possible information about this product. This||
1311|003|Z|information does not assure that this product is safe, effective,||
1311|004|Z|or appropriate for you. This information is not individual||
1311|005|Z|medical advice and does not substitute for the advice of your||
1311|006|Z|health care professional. Always ask your health care||
1311|007|Z|professional for complete information about this product and your||
1311|008|Z|specific health needs.||
1311|009|B|||
1311|010|T|BLACK COHOSH - ORAL||
1311|011|B|||
1311|012|U|USES:  Black cohosh has been used for symptoms of menopause (such||
1311|013|U|as hot flashes).||
1311|014|U|   Some herbal/diet supplement products have been found to||
1311|015|U|contain possibly harmful impurities/additives. Check with your||
1311|016|U|pharmacist for more details about the brand you use.||
1311|017|U|   The FDA has not reviewed this product for safety or||
1311|018|U|effectiveness. Consult your doctor or pharmacist for more||
1311|019|U|details.||
1311|020|B|||
1311|021|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
1311|022|H|directions on the product package. If you have any questions, ask||
1311|023|H|your doctor or pharmacist.||
1311|024|H|   This herbal product should not be used for more than 6 months.||
1311|025|H|   If your condition lasts or gets worse, or if you think you may||
1311|026|H|have a serious medical problem, get medical help right away.||
1311|027|B|||
1311|028|S|SIDE EFFECTS:  Headache, stomach upset, nausea, vomiting, weight||
1311|029|S|gain, vaginal spotting/bleeding, and dizziness may occur. If any||
1311|030|S|of these effects last or get worse, contact your doctor promptly.||
1311|031|S|   To reduce the risk of dizziness and lightheadedness, get up||
1311|032|S|slowly when rising from a sitting or lying position.||
1311|033|S|   Tell your doctor right away if you have any serious side||
1311|034|S|effects, including: muscle pain/weakness.||
1311|035|S|   This product may rarely cause serious (possibly fatal) liver||
1311|036|S|disease. Stop taking this product and consult your doctor right||
1311|037|S|away if you develop symptoms of liver injury, including nausea||
1311|038|S|that doesn't stop, loss of appetite, unusual tiredness,||
1311|039|S|stomach/abdominal pain, pale stools, dark urine, yellowing||
1311|040|S|eyes/skin.||
1311|041|S|   A very serious allergic reaction to this product is rare.||
1311|042|S|However, get medical help right away if you notice any symptoms||
1311|043|S|of a serious allergic reaction, including: rash, itching/swelling||
1311|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1311|045|S|breathing.||
1311|046|S|   This is not a complete list of possible side effects. If you||
1311|047|S|notice other effects not listed above, contact your doctor or||
1311|048|S|pharmacist.||
1311|049|S|   In the US -||
1311|050|S|   Call your doctor for medical advice about side effects. You||
1311|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1311|052|S|www.fda.gov/medwatch.||
1311|053|S|   In Canada - Call your doctor for medical advice about side||
1311|054|S|effects. You may report side effects to Health Canada at||
1311|055|S|1-866-234-2345.||
1311|056|B|||
1311|057|P|PRECAUTIONS:  Before taking black cohosh, tell your doctor or||
1311|058|P|pharmacist if you are allergic to it; or to salicylates (such as||
1311|059|P|aspirin); or if you have any other allergies. This product||
1311|060|P|contains salicylates. This product may contain inactive||
1311|061|P|ingredients, which can cause allergic reactions or other||
1311|062|P|problems. Talk to your pharmacist for more details.||
1311|063|P|   If you have any of the following health problems, consult your||
1311|064|P|doctor or pharmacist before using this product: hormone-sensitive||
1311|065|P|cancer (such as breast, ovarian, endometrial), high risk of||
1311|066|P|breast cancer, clotting problems (such as protein S deficiency,||
1311|067|P|stroke), heart problems (such as heart attack, heart failure),||
1311|068|P|high blood pressure, liver problems, problems of the uterus (such||
1311|069|P|as endometriosis, fibroids).||
1311|070|P|   This product may make you dizzy. Alcohol or marijuana||
1311|071|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
1311|072|P|or do anything that needs alertness until you can do it safely.||
1311|073|P|Limit alcoholic beverages. Talk to your doctor if you are using||
1311|074|P|marijuana (cannabis).||
1311|075|P|   Liquid preparations of this product may contain sugar and/or||
1311|076|P|alcohol. Caution is advised if you have diabetes, alcohol||
1311|077|P|dependence, or liver disease. Ask your doctor or pharmacist about||
1311|078|P|using this product safely.||
1311|079|P|   Before having surgery, tell your doctor or dentist about all||
1311|080|P|the products you use (including prescription drugs,||
1311|081|P|nonprescription drugs, and herbal products).||
1311|082|P|   Black cohosh is not recommended for use during pregnancy. It||
1311|083|P|may cause premature labor. Consult your doctor before using this||
1311|084|P|product.||
1311|085|P|   It is unknown if this product passes into breast milk.||
1311|086|P|Breastfeeding is not recommended while using this product.||
1311|087|P|Consult your doctor before breastfeeding.||
1311|088|B|||
1311|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1311|090|I|medications work or increase your risk for serious side effects.||
1311|091|I|This document does not contain all possible drug interactions.||
1311|092|I|Keep a list of all the products you use (including||
1311|093|I|prescription/nonprescription drugs and herbal products) and share||
1311|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
1311|095|I|the dosage of any medicines without your doctor's approval.||
1311|096|I|   Some drugs that may interact with this product include:||
1311|097|I|cisplatin, warfarin.||
1311|098|I|   Check the labels on all your pain relievers/fever reducers||
1311|099|I|because they may contain aspirin (which is like an ingredient in||
1311|100|I|this product). If your doctor has told you to take low-dose||
1311|101|I|aspirin to prevent heart attack or stroke (usually 81-162||
1311|102|I|milligrams a day), you should keep taking the aspirin unless your||
1311|103|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1311|104|I|details.||
1311|105|B|||
1311|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1311|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1311|108|O|poison control center right away. US residents can call||
1311|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1311|110|O|Symptoms of overdose may include: slow heartbeat, vision||
1311|111|O|problems, severe dizziness, increased sweating, seizure.||
1311|112|B|||
1311|113|N|NOTES:  Tell your doctor that you are taking black cohosh. Lab||
1311|114|N|and/or medical tests (such as liver function) may be done while||
1311|115|N|you are taking this product. Keep all medical and lab||
1311|116|N|appointments.||
1311|117|N|   Check product labeling carefully. Some products may contain a||
1311|118|N|combination of both black and blue cohosh. Blue cohosh has||
1311|119|N|different effects and is used for different purposes.||
1311|120|B|||
1311|121|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1311|122|D|remember. If it is near the time of the next dose, skip the||
1311|123|D|missed dose. Take your next dose at the regular time. Do not||
1311|124|D|double the dose to catch up.||
1311|125|B|||
1311|126|R|STORAGE:  Refer to storage information printed on the package. If||
1311|127|R|you have any questions about storage, ask your pharmacist. Keep||
1311|128|R|all medications and herbal products away from children and pets.||
1311|129|R|   Do not flush medications down the toilet or pour them into a||
1311|130|R|drain unless instructed to do so. Properly discard this product||
1311|131|R|when it is expired or no longer needed. Consult your pharmacist||
1311|132|R|or local waste disposal company.||
1311|133|B|||
1311|134|A|Information last revised January 2025.||
1311|135|A|Copyright(c) 2025 First Databank, Inc.||
1311|136|B|||
1314|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1314|002|Z|does NOT have all possible information about this product. This||
1314|003|Z|information does not assure that this product is safe, effective,||
1314|004|Z|or appropriate for you. This information is not individual||
1314|005|Z|medical advice and does not substitute for the advice of your||
1314|006|Z|health care professional. Always ask your health care||
1314|007|Z|professional for complete information about this product and your||
1314|008|Z|specific health needs.||
1314|009|B|||
1314|010|T|WITCH HAZEL (Hamamelis virginiana) - TOPICAL||
1314|011|B|||
1314|012|U|USES:  Witch hazel has been used to relieve swelling, bleeding,||
1314|013|U|itching, minor pain, and discomfort caused by minor skin||
1314|014|U|irritations (such as cuts, scrapes, insect bites). It is also||
1314|015|U|used to relieve itching, discomfort, irritation, and burning||
1314|016|U|caused by hemorrhoids.||
1314|017|U|   Some herbal/diet supplement products have been found to||
1314|018|U|contain possibly harmful impurities/additives. Check with your||
1314|019|U|pharmacist for more details about the brand you use.||
1314|020|U|   The FDA has not reviewed this product for safety or||
1314|021|U|effectiveness. Consult your doctor or pharmacist for more||
1314|022|U|details.||
1314|023|B|||
1314|024|H|HOW TO USE:  Apply this product to the affected area as directed.||
1314|025|H|Follow all directions and warnings on the product package. If you||
1314|026|H|have any questions, ask your doctor or pharmacist.||
1314|027|H|   Tell your doctor if your condition lasts or gets worse. If you||
1314|028|H|think you may have a serious medical problem, get medical help||
1314|029|H|right away.||
1314|030|B|||
1314|031|S|SIDE EFFECTS:  There are no reports of any side effects due to||
1314|032|S|this product. However, tell the doctor if you experience any||
1314|033|S|unpleasant effects while using this product.||
1314|034|S|   A very serious allergic reaction to this product is rare.||
1314|035|S|However, get medical help right away if you notice any symptoms||
1314|036|S|of a serious allergic reaction, including: rash, itching/swelling||
1314|037|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1314|038|S|breathing.||
1314|039|S|   This is not a complete list of possible side effects. If you||
1314|040|S|notice other effects not listed above, contact your doctor or||
1314|041|S|pharmacist.||
1314|042|S|   In the US -||
1314|043|S|   Call your doctor for medical advice about side effects. You||
1314|044|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1314|045|S|www.fda.gov/medwatch.||
1314|046|S|   In Canada - Call your doctor for medical advice about side||
1314|047|S|effects. You may report side effects to Health Canada at||
1314|048|S|1-866-234-2345.||
1314|049|B|||
1314|050|P|PRECAUTIONS:  Before using witch hazel, tell your doctor or||
1314|051|P|pharmacist if you are allergic to it; or if you have any other||
1314|052|P|allergies. This product may contain inactive ingredients, which||
1314|053|P|can cause allergic reactions or other problems. Talk to your||
1314|054|P|pharmacist for more details.||
1314|055|P|   During pregnancy, this product should be used only when||
1314|056|P|clearly needed. Discuss the risks and benefits with your doctor.||
1314|057|P|   It is unknown if this product passes into breast milk. Consult||
1314|058|P|your doctor before breastfeeding.||
1314|059|B|||
1314|060|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1314|061|I|medications work or increase your risk for serious side effects.||
1314|062|I|This document does not contain all possible drug interactions.||
1314|063|I|Keep a list of all the products you use (including||
1314|064|I|prescription/nonprescription drugs and herbal products) and share||
1314|065|I|it with your doctor and pharmacist. Do not start, stop, or change||
1314|066|I|the dosage of any medicines without your doctor's approval.||
1314|067|B|||
1314|068|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1314|069|O|has overdosed and has serious symptoms such as passing out or||
1314|070|O|trouble breathing, call 911. Otherwise, call a poison control||
1314|071|O|center right away. US residents can call 1-800-222-1222. Canada||
1314|072|O|residents can call 1-844-764-7669.||
1314|073|B|||
1314|074|N|NOTES:  Keep all medical and lab appointments.||
1314|075|B|||
1314|076|D|MISSED DOSE:  Not applicable.||
1314|077|B|||
1314|078|R|STORAGE:  Refer to storage information printed on the package. If||
1314|079|R|you have any questions about storage, ask your pharmacist. Keep||
1314|080|R|all medications and herbal products away from children and pets.||
1314|081|R|   Do not flush medications down the toilet or pour them into a||
1314|082|R|drain unless instructed to do so. Properly discard this product||
1314|083|R|when it is expired or no longer needed. Consult your pharmacist||
1314|084|R|or local waste disposal company.||
1314|085|B|||
1314|086|A|Information last revised May 2024.||
1314|087|A|Copyright(c) 2025 First Databank, Inc.||
1314|088|B|||
1317|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1317|002|Z|does NOT have all possible information about this product. This||
1317|003|Z|information does not assure that this product is safe, effective,||
1317|004|Z|or appropriate for you. This information is not individual||
1317|005|Z|medical advice and does not substitute for the advice of your||
1317|006|Z|health care professional. Always ask your health care||
1317|007|Z|professional for complete information about this product and your||
1317|008|Z|specific health needs.||
1317|009|B|||
1317|010|T|GANCICLOVIR - OPHTHALMIC||
1317|011|F|(gan-SYE-klo-veer)||
1317|012|B|||
1317|013|C|COMMON BRAND NAME(S): Zirgan||
1317|014|B|||
1317|015|U|USES:  Ganciclovir is used to treat herpes infection of the eye.||
1317|016|U|Although ganciclovir stops the growth of the virus, it is not a||
1317|017|U|cure for the herpes infection. Herpes virus continues to live in||
1317|018|U|the body even between outbreaks of infection. However, treating||
1317|019|U|an outbreak may help the sores in the eye to heal faster and||
1317|020|U|lower the risk of complications (such as decreased vision,||
1317|021|U|blindness).||
1317|022|U|   Ganciclovir is an anti-viral drug. This medication treats only||
1317|023|U|herpes eye infections. It will not work for other types of eye||
1317|024|U|infections, such as those caused by bacteria. Unnecessary use or||
1317|025|U|misuse of any anti-infective drug can lead to its decreased||
1317|026|U|effectiveness.||
1317|027|B|||
1317|028|H|HOW TO USE:  Apply this medication to the affected eye as||
1317|029|H|directed by your doctor, usually 5 times a day (about every 3||
1317|030|H|hours while awake) until the eye has healed, and then 3 times a||
1317|031|H|day for 7 more days.||
1317|032|H|   To apply eye medication, wash your hands first. To avoid||
1317|033|H|contamination, do not touch the dropper tip or let it touch your||
1317|034|H|eye or any other surface.||
1317|035|H|   Do not wear contact lenses while you have an eye infection or||
1317|036|H|while using this medication. Sterilize contact lenses according||
1317|037|H|to the manufacturer's directions, and check with your doctor||
1317|038|H|before you begin using them again.||
1317|039|H|   Tilt your head back, look upward, and pull down the lower||
1317|040|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1317|041|H|and place one drop into the pouch. Look downward, gently close||
1317|042|H|your eyes, and place one finger at the corner of your eye (near||
1317|043|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
1317|044|H|opening your eyes. This will prevent the medication from draining||
1317|045|H|out. Try not to blink or rub your eye. Repeat these steps for||
1317|046|H|your other eye if so directed.||
1317|047|H|   Do not rinse the dropper. Replace the dropper cap after each||
1317|048|H|use.||
1317|049|H|   If you are using another kind of eye medication (such as drops||
1317|050|H|or ointments), wait at least 5 minutes between applying each||
1317|051|H|medication. Use eye drops before eye ointments to allow the drops||
1317|052|H|to enter the eye.||
1317|053|H|   Wait several minutes for your vision to clear before driving||
1317|054|H|or operating machinery.||
1317|055|H|   Use this medication regularly to get the most benefit from it.||
1317|056|H|To help you remember, use it at the same times each day. Continue||
1317|057|H|to use this medication for the full time prescribed, even if||
1317|058|H|symptoms disappear after a few days. Stopping the medication too||
1317|059|H|early may result in a return of the infection.||
1317|060|H|   Tell your doctor if your condition lasts or if it gets worse||
1317|061|H|(for example, you develop eye pain/itching/swelling).||
1317|062|B|||
1317|063|S|SIDE EFFECTS:  Temporary blurred vision after you apply this||
1317|064|S|medication and mild eye irritation/redness may occur. If any of||
1317|065|S|these effects last or get worse, tell your doctor or pharmacist||
1317|066|S|promptly.||
1317|067|S|   Remember that this medication has been prescribed because your||
1317|068|S|doctor has judged that the benefit to you is greater than the||
1317|069|S|risk of side effects. Many people using this medication do not||
1317|070|S|have serious side effects.||
1317|071|S|   A very serious allergic reaction to this drug is rare.||
1317|072|S|However, get medical help right away if you notice any symptoms||
1317|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1317|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1317|075|S|breathing.||
1317|076|S|   This is not a complete list of possible side effects. If you||
1317|077|S|notice other effects not listed above, contact your doctor or||
1317|078|S|pharmacist.||
1317|079|S|   In the US -||
1317|080|S|   Call your doctor for medical advice about side effects. You||
1317|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1317|082|S|www.fda.gov/medwatch.||
1317|083|S|   In Canada - Call your doctor for medical advice about side||
1317|084|S|effects. You may report side effects to Health Canada at||
1317|085|S|1-866-234-2345.||
1317|086|B|||
1317|087|P|PRECAUTIONS:  Before using ganciclovir, tell your doctor or||
1317|088|P|pharmacist if you are allergic to it; or to valganciclovir; or if||
1317|089|P|you have any other allergies. This product may contain inactive||
1317|090|P|ingredients, which can cause allergic reactions or other||
1317|091|P|problems. Talk to your pharmacist for more details.||
1317|092|P|   Before using this medication, tell your doctor or pharmacist||
1317|093|P|your medical history.||
1317|094|P|   After you apply this drug, your vision may become temporarily||
1317|095|P|blurred. Do not drive, use machinery, or do anything that needs||
1317|096|P|clear vision until you can do it safely.||
1317|097|P|   Before having surgery, tell your doctor or dentist about all||
1317|098|P|the products you use (including prescription drugs,||
1317|099|P|nonprescription drugs, and herbal products).||
1317|100|P|   During pregnancy, this medication should be used only when||
1317|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
1317|102|P|   It is unknown if this drug passes into breast milk. Consult||
1317|103|P|your doctor before breastfeeding.||
1317|104|B|||
1317|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1317|106|I|medications work or increase your risk for serious side effects.||
1317|107|I|This document does not contain all possible drug interactions.||
1317|108|I|Keep a list of all the products you use (including||
1317|109|I|prescription/nonprescription drugs and herbal products) and share||
1317|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
1317|111|I|the dosage of any medicines without your doctor's approval.||
1317|112|B|||
1317|113|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1317|114|O|has overdosed and has serious symptoms such as passing out or||
1317|115|O|trouble breathing, call 911. Otherwise, call a poison control||
1317|116|O|center right away. US residents can call 1-800-222-1222. Canada||
1317|117|O|residents can call 1-844-764-7669.||
1317|118|B|||
1317|119|N|NOTES:  Do not share this medication with others.||
1317|120|N|   This medication has been prescribed for your current condition||
1317|121|N|only. Do not use it later for another infection unless your||
1317|122|N|doctor tells you to.||
1317|123|N|   Lab and/or medical tests (such as eye exams) may be done while||
1317|124|N|you are using this medication. Keep all medical and lab||
1317|125|N|appointments. Consult your doctor for more details.||
1317|126|B|||
1317|127|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1317|128|D|If it is near the time of the next dose, skip the missed dose.||
1317|129|D|Use your next dose at the regular time. Do not double the dose to||
1317|130|D|catch up.||
1317|131|B|||
1317|132|R|STORAGE:  Store at room temperature. Protect from freezing. Keep||
1317|133|R|all medications away from children and pets.||
1317|134|R|   Do not flush medications down the toilet or pour them into a||
1317|135|R|drain unless instructed to do so. Properly discard this product||
1317|136|R|when it is expired or no longer needed. Consult your pharmacist||
1317|137|R|or local waste disposal company.||
1317|138|B|||
1317|139|A|Information last revised May 2024.||
1317|140|A|Copyright(c) 2025 First Databank, Inc.||
1317|141|B|||
1319|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1319|002|Z|does NOT have all possible information about this product. This||
1319|003|Z|information does not assure that this product is safe, effective,||
1319|004|Z|or appropriate for you. This information is not individual||
1319|005|Z|medical advice and does not substitute for the advice of your||
1319|006|Z|health care professional. Always ask your health care||
1319|007|Z|professional for complete information about this product and your||
1319|008|Z|specific health needs.||
1319|009|B|||
1319|010|T|EVEROLIMUS (TRANSPLANT) - ORAL||
1319|011|F|(/E-ver-OH-li-mus)||
1319|012|B|||
1319|013|C|COMMON BRAND NAME(S): Zortress||
1319|014|B|||
1319|015|W|WARNING:  Everolimus can increase your risk for developing||
1319|016|W|certain types of cancers (including skin cancer, lymphoma). Tell||
1319|017|W|your doctor right away if you notice unusual skin changes, change||
1319|018|W|in the appearance/size of moles, unusual growths/lumps, swollen||
1319|019|W|lymph nodes, night sweats, or loss of appetite/weight loss.||
1319|020|W|   This medication lowers your ability to fight infections. This||
1319|021|W|may make you more likely to get a serious (rarely fatal)||
1319|022|W|infection or make any infection you have worse. Tell your doctor||
1319|023|W|right away if you have any signs of infection (such as sore||
1319|024|W|throat that doesn't go away, fever, chills).||
1319|025|W|   Using this medication may increase your risk for developing a||
1319|026|W|blood clot in your kidney transplant, usually within the first 30||
1319|027|W|days after surgery. Tell your doctor right away if you have||
1319|028|W|nausea/vomiting, pain in your groin/lower back/abdomen, blood in||
1319|029|W|your urine, or unusual decrease in the amount of urine.||
1319|030|W|   This medication may increase the risk of death from infection||
1319|031|W|in people who have had a heart transplant. Before using this||
1319|032|W|medication, tell your doctor if you have had a heart transplant.||
1319|033|B|||
1319|034|U|USES:  Everolimus is used with other medications (such as||
1319|035|U|cyclosporine) to prevent rejection of a kidney transplant.||
1319|036|U|Everolimus is also used with other medications (such as||
1319|037|U|tacrolimus) to prevent rejection of a liver transplant. This||
1319|038|U|medication belongs to a class of drugs known as||
1319|039|U|immunosuppressants. It works by weakening your body's defense||
1319|040|U|system (immune system) to help your body accept the new organ as||
1319|041|U|if it were your own.||
1319|042|B|||
1319|043|V|OTHER USES:  This section contains uses of this drug that are not||
1319|044|V|listed in the approved professional labeling for the drug but||
1319|045|V|that may be prescribed by your health care professional. Use this||
1319|046|V|drug for a condition that is listed in this section only if it||
1319|047|V|has been so prescribed by your health care professional.||
1319|048|V|   This drug may also be used for certain types of cancers and||
1319|049|V|benign tumors.||
1319|050|B|||
1319|051|H|HOW TO USE:  Read the Medication Guide provided by your||
1319|052|H|pharmacist before you start taking everolimus and each time you||
1319|053|H|get a refill. If you have any questions, ask your doctor or||
1319|054|H|pharmacist.||
1319|055|H|   Take this medication by mouth as directed by your doctor,||
1319|056|H|usually every 12 hours with your cyclosporine dose, beginning||
1319|057|H|immediately after a kidney transplant. Everolimus is usually||
1319|058|H|started 30 days after a liver transplant and is usually taken||
1319|059|H|every 12 hours with your tacrolimus dose. You may take this||
1319|060|H|medication with or without food, but it is important to choose||
1319|061|H|one way and take this medication the same way with every dose.||
1319|062|H|Swallow this medication whole with a glass of water. Do not||
1319|063|H|crush, chew, or break the tablets.||
1319|064|H|   The dosage is based on your medical condition, response to||
1319|065|H|treatment, lab tests, and other medications you may be taking. Be||
1319|066|H|sure to tell your doctor and pharmacist about all the products||
1319|067|H|you use (including prescription drugs, nonprescription drugs, and||
1319|068|H|herbal products).||
1319|069|H|   Use this medication regularly to get the most benefit from it.||
1319|070|H|To help you remember, take it at the same times each day.||
1319|071|H|   Do not increase your dose or use this medication more often or||
1319|072|H|for longer than prescribed. Your condition will not improve any||
1319|073|H|faster, and your risk of side effects will increase.||
1319|074|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1319|075|H|using this medication unless your doctor or pharmacist says you||
1319|076|H|may do so safely. Grapefruit can increase the chance of side||
1319|077|H|effects with this medicine. Ask your doctor or pharmacist for||
1319|078|H|more details.||
1319|079|H|   Since this drug can be absorbed through the skin and lungs and||
1319|080|H|may harm an unborn baby, women who are pregnant or who may become||
1319|081|H|pregnant should not handle this medication or breathe the dust||
1319|082|H|from the tablets.||
1319|083|B|||
1319|084|S|SIDE EFFECTS:  See also Warning section.||
1319|085|S|   Constipation, headache, nausea, and sores in the mouth/throat||
1319|086|S|may occur. If any of these effects last or get worse, tell your||
1319|087|S|doctor or pharmacist promptly.||
1319|088|S|   People using this medication may have serious side effects.||
1319|089|S|However, you have been prescribed this drug because your doctor||
1319|090|S|has judged that the benefit to you is greater than the risk of||
1319|091|S|side effects. Careful monitoring by your doctor may decrease your||
1319|092|S|risk.||
1319|093|S|   Tell your doctor right away if you have any serious side||
1319|094|S|effects, including: swelling hands/ankles/feet, wound problems||
1319|095|S|(such as infection, slow wound healing, opening of wound),||
1319|096|S|decreased sexual ability (in men), chest pain/pressure, shortness||
1319|097|S|of breath, unusual bruising/bleeding.||
1319|098|S|   This medication may make side effects from radiation treatment||
1319|099|S|worse. These side effects can sometimes be severe. Tell your||
1319|100|S|doctor if you have had or are planning to have radiation||
1319|101|S|treatment.||
1319|102|S|   This medication has caused very serious (rarely fatal) lung||
1319|103|S|problems. Get medical help right away if you have symptoms of||
1319|104|S|lung problems, such as shortness of breath, chest pain.||
1319|105|S|   This medication may increase your risk of getting a rare but||
1319|106|S|very serious (sometimes fatal) brain infection (progressive||
1319|107|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1319|108|S|if any of these rare but very serious side effects occur:||
1319|109|S|clumsiness, loss of coordination, weakness, sudden change in your||
1319|110|S|thinking (such as confusion, difficulty concentrating),||
1319|111|S|difficulty moving your muscles, problems with speech, seizure,||
1319|112|S|vision changes.||
1319|113|S|   Everolimus may cause your cholesterol/triglycerides or blood||
1319|114|S|sugar to increase. You may be required to have your||
1319|115|S|cholesterol/triglycerides or blood sugar checked periodically.||
1319|116|S|You may need medication to control your cholesterol/triglycerides||
1319|117|S|or blood sugar. Tell your doctor or pharmacist if you experience||
1319|118|S|symptoms of high blood sugar, including increased thirst/hunger,||
1319|119|S|frequent urination.||
1319|120|S|   A very serious allergic reaction to this drug is rare.||
1319|121|S|However, get medical help right away if you notice any symptoms||
1319|122|S|of a serious allergic reaction, including: rash, itching/swelling||
1319|123|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1319|124|S|breathing.||
1319|125|S|   This is not a complete list of possible side effects. If you||
1319|126|S|notice other effects not listed above, contact your doctor or||
1319|127|S|pharmacist.||
1319|128|S|   In the US -||
1319|129|S|   Call your doctor for medical advice about side effects. You||
1319|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1319|131|S|www.fda.gov/medwatch.||
1319|132|S|   In Canada - Call your doctor for medical advice about side||
1319|133|S|effects. You may report side effects to Health Canada at||
1319|134|S|1-866-234-2345.||
1319|135|B|||
1319|136|P|PRECAUTIONS:  See also Warning section.||
1319|137|P|   Before taking everolimus, tell your doctor or pharmacist if||
1319|138|P|you are allergic to it; or to sirolimus or temsirolimus; or if||
1319|139|P|you have any other allergies. This product may contain inactive||
1319|140|P|ingredients, which can cause allergic reactions or other||
1319|141|P|problems. Talk to your pharmacist for more details.||
1319|142|P|   Before using this medication, tell your doctor or pharmacist||
1319|143|P|your medical history, especially of: high||
1319|144|P|cholesterol/triglyceride levels, any recent/current infections,||
1319|145|P|diabetes, liver disease, radiation treatment, certain hereditary||
1319|146|P|enzyme problems (galactose intolerance, Lapp lactase deficiency,||
1319|147|P|glucose-galactose malabsorption).||
1319|148|P|   Everolimus can make you more likely to get infections or may||
1319|149|P|make current infections worse. Stay away from anyone who has an||
1319|150|P|infection that may easily spread (such as chickenpox, COVID-19,||
1319|151|P|measles, flu). Talk to your doctor if you have been exposed to an||
1319|152|P|infection or for more details.||
1319|153|P|   Tell your health care professional that you are using||
1319|154|P|everolimus before having any immunizations/vaccinations. Avoid||
1319|155|P|contact with people who have recently received live vaccines||
1319|156|P|(such as flu vaccine inhaled through the nose).||
1319|157|P|   To lower the chance of getting cut, bruised, or injured, use||
1319|158|P|caution with sharp objects like razors and nail cutters, and||
1319|159|P|avoid activities such as contact sports.||
1319|160|P|   Since this medication may increase your risk of developing||
1319|161|P|skin cancer, limit your time in the sun. Avoid tanning booths and||
1319|162|P|sunlamps. Use sunscreen and wear protective clothing when||
1319|163|P|outdoors.||
1319|164|P|   Before having surgery, tell your doctor or dentist about all||
1319|165|P|the products you use (including prescription drugs,||
1319|166|P|nonprescription drugs, and herbal products).||
1319|167|P|   This medication can affect fertility in both males and||
1319|168|P|females. Ask your doctor for more details.||
1319|169|P|   Tell your doctor if you are pregnant or plan to become||
1319|170|P|pregnant. You should not become pregnant while using everolimus.||
1319|171|P|Everolimus may harm an unborn baby. Women using this medication||
1319|172|P|should ask about reliable forms of birth control during treatment||
1319|173|P|and for 8 weeks after the last dose. Men using this medication||
1319|174|P|should ask about reliable forms of birth control during treatment||
1319|175|P|and for 4 weeks after the last dose. If you or your partner||
1319|176|P|becomes pregnant, talk to your doctor right away about the risks||
1319|177|P|and benefits of this medication.||
1319|178|P|   Since this drug can be absorbed through the skin and lungs and||
1319|179|P|may harm an unborn baby, women who are pregnant or who may become||
1319|180|P|pregnant should not handle this medication or breathe the dust||
1319|181|P|from the tablets.||
1319|182|P|   It is unknown if this medication passes into breast milk.||
1319|183|P|Because of the possible risk to the infant, breastfeeding is not||
1319|184|P|recommended while using this medication and for 2 weeks after the||
1319|185|P|last dose. Consult your doctor before breastfeeding.||
1319|186|B|||
1319|187|I|DRUG INTERACTIONS:  See also How to Use section.||
1319|188|I|   Drug interactions may change how your medications work or||
1319|189|I|increase your risk for serious side effects. This document does||
1319|190|I|not contain all possible drug interactions. Keep a list of all||
1319|191|I|the products you use (including prescription/nonprescription||
1319|192|I|drugs and herbal products) and share it with your doctor and||
1319|193|I|pharmacist. Do not start, stop, or change the dosage of any||
1319|194|I|medicines without your doctor's approval.||
1319|195|I|   Some products that may interact with this drug include: other||
1319|196|I|drugs that weaken the immune system/increase the risk of||
1319|197|I|infection (such as natalizumab, rituximab), ACE inhibitors (such||
1319|198|I|as captopril, lisinopril).||
1319|199|I|   Other medications can affect the removal of everolimus from||
1319|200|I|your body, which may affect how everolimus works. Examples||
1319|201|I|include azole antifungals (such as itraconazole, ketoconazole),||
1319|202|I|cobicistat, macrolide antibiotics (such as clarithromycin,||
1319|203|I|erythromycin), HIV protease inhibitors (such as atazanavir),||
1319|204|I|rifamycins (such as rifabutin, rifampin), ritonavir, St. John's||
1319|205|I|wort, telithromycin, among others.||
1319|206|B|||
1319|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1319|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1319|209|O|poison control center right away. US residents can call||
1319|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1319|211|B|||
1319|212|N|NOTES:  Do not share this medication with others.||
1319|213|N|   Lab and/or medical tests (such as||
1319|214|N|everolimus/cyclosporine/tacrolimus blood levels,||
1319|215|N|cholesterol/triglyceride levels, kidney function, urine protein,||
1319|216|N|complete blood count, blood sugar) should be done while you are||
1319|217|N|taking this medication. Keep all medical and lab appointments.||
1319|218|N|Consult your doctor for more details.||
1319|219|B|||
1319|220|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1319|221|D|remember. If it is near the time of the next dose, skip the||
1319|222|D|missed dose. Take your next dose at the regular time. Do not||
1319|223|D|double the dose to catch up.||
1319|224|B|||
1319|225|R|STORAGE:  Store at room temperature away from light and moisture.||
1319|226|R|Do not store in the bathroom. Keep all medications away from||
1319|227|R|children and pets.||
1319|228|R|   Do not flush medications down the toilet or pour them into a||
1319|229|R|drain unless instructed to do so. Properly discard this product||
1319|230|R|when it is expired or no longer needed. Consult your pharmacist||
1319|231|R|or local waste disposal company.||
1319|232|B|||
1319|233|M|MEDICAL ALERT:  Your condition can cause complications in a||
1319|234|M|medical emergency. For information about enrolling in MedicAlert,||
1319|235|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1319|236|B|||
1319|237|A|Information last revised May 2025.||
1319|238|A|Copyright(c) 2025 First Databank, Inc.||
1319|239|B|||
1321|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1321|002|Z|does NOT have all possible information about this product. This||
1321|003|Z|information does not assure that this product is safe, effective,||
1321|004|Z|or appropriate for you. This information is not individual||
1321|005|Z|medical advice and does not substitute for the advice of your||
1321|006|Z|health care professional. Always ask your health care||
1321|007|Z|professional for complete information about this product and your||
1321|008|Z|specific health needs.||
1321|009|B|||
1321|010|T|NAPROXEN/ESOMEPRAZOLE - ORAL||
1321|011|F|(na-PROX-en/ES-oh-MEP-ra-zole)||
1321|012|B|||
1321|013|C|COMMON BRAND NAME(S): Vimovo||
1321|014|B|||
1321|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1321|016|W|naproxen) may rarely increase the risk for a heart attack or||
1321|017|W|stroke. This effect can happen at any time while taking this drug||
1321|018|W|but is more likely if you take it for a long time. The risk may||
1321|019|W|be greater in older adults or if you have heart disease or||
1321|020|W|increased risk for heart disease (for example, due to smoking,||
1321|021|W|family history of heart disease, or conditions such as high blood||
1321|022|W|pressure or diabetes). Do not take this drug right before or||
1321|023|W|after heart bypass surgery (CABG). Also, this drug may rarely||
1321|024|W|cause serious (rarely fatal) bleeding from the stomach or||
1321|025|W|intestines. This can occur without warning symptoms and at any||
1321|026|W|time during treatment. The risk of bleeding is greater in older||
1321|027|W|adults. Esomeprazole decreases the risk of bleeding.||
1321|028|W|   Stop taking this medication and get medical help right away if||
1321|029|W|you notice any of the following rare but very serious side||
1321|030|W|effects: stomach/abdominal pain that doesn't go away,||
1321|031|W|chest/jaw/left arm pain, severe dizziness, weakness on one side||
1321|032|W|of the body, vision changes, trouble speaking, black stools,||
1321|033|W|vomit that looks like coffee grounds. (See also Precautions||
1321|034|W|section.)||
1321|035|W|   Talk with your doctor or pharmacist about the risks and||
1321|036|W|benefits of treatment with this medication.||
1321|037|B|||
1321|038|U|USES:  This medication is used to treat the signs and symptoms of||
1321|039|U|rheumatoid arthritis, osteoarthritis, juvenile idiopathic||
1321|040|U|arthritis, and ankylosing spondylitis when there is a high risk||
1321|041|U|for stomach bleeding/ulcer. This product contains 2 medications:||
1321|042|U|esomeprazole and naproxen. This product should not be used to||
1321|043|U|relieve sudden pain. The naproxen starts to work slower than||
1321|044|U|other naproxen products because of a special coating||
1321|045|U|(delayed-release).||
1321|046|U|   If you are treating a chronic condition such as arthritis, ask||
1321|047|U|your doctor about non-drug treatments and/or using other||
1321|048|U|medications to treat your pain. See also Warning section.||
1321|049|U|   Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It||
1321|050|U|reduces pain, swelling, and joint stiffness. Naproxen can cause||
1321|051|U|stomach ulcers, especially in patients with a history of stomach||
1321|052|U|ulcers. Esomeprazole is a proton pump inhibitor (PPI) that blocks||
1321|053|U|acid production in the stomach. This combination provides the||
1321|054|U|benefits of naproxen and may reduce the risk of ulcers or||
1321|055|U|bleeding that can occur with naproxen use.||
1321|056|B|||
1321|057|H|HOW TO USE:  Read the Medication Guide provided by your||
1321|058|H|pharmacist before you start using this medication and each time||
1321|059|H|you get a refill. If you have any questions, ask your doctor or||
1321|060|H|pharmacist.||
1321|061|H|   Take this medication by mouth as directed by your doctor,||
1321|062|H|usually twice daily (in the morning and evening) at least 30||
1321|063|H|minutes before a meal. Take it with a full glass (8 ounces or 240||
1321|064|H|milliliters) of water unless your doctor directs you otherwise.||
1321|065|H|Do not lie down for at least 10 minutes after taking this drug.||
1321|066|H|Swallow the tablet whole. Do not break, chew, crush or dissolve||
1321|067|H|the tablet. Doing so can destroy the slow release of the drug and||
1321|068|H|may increase side effects. If needed, you can take antacids while||
1321|069|H|using this medication.||
1321|070|H|   The dosage is based on your medical condition and response to||
1321|071|H|treatment. Children's dosage is also based on weight. To reduce||
1321|072|H|your risk of stomach bleeding and other side effects, take this||
1321|073|H|medication at the lowest effective dose for the shortest possible||
1321|074|H|time. Do not increase your dose, take it more often, or take it||
1321|075|H|for longer than prescribed.||
1321|076|H|   Use this medication regularly in order to get the most benefit||
1321|077|H|from it. Remember to use it at the same times each day. It may||
1321|078|H|take up to 2 weeks of taking this drug until you get the full||
1321|079|H|benefit.||
1321|080|H|   Tell your doctor if your condition lasts or gets worse. The||
1321|081|H|risk of side effects goes up over time. Ask your doctor how long||
1321|082|H|you should take this medication.||
1321|083|B|||
1321|084|S|SIDE EFFECTS:  See also Warning section.||
1321|085|S|   Upset stomach, heartburn, diarrhea, drowsiness, or dizziness||
1321|086|S|may occur. If any of these effects last or get worse, notify your||
1321|087|S|doctor or pharmacist promptly.||
1321|088|S|   Remember that this medication has been prescribed because your||
1321|089|S|doctor has judged that the benefit to you is greater than the||
1321|090|S|risk of side effects. Many people using this medication do not||
1321|091|S|have serious side effects.||
1321|092|S|   This medication may raise your blood pressure. Check your||
1321|093|S|blood pressure regularly and tell your doctor if the results are||
1321|094|S|high.||
1321|095|S|   Tell your doctor right away if you have any serious side||
1321|096|S|effects, including: easy bruising/bleeding,||
1321|097|S|lightheadedness/fainting, signs of a lung infection (such as||
1321|098|S|fever, cough, trouble breathing), difficult/painful swallowing,||
1321|099|S|symptoms of a low magnesium blood level (such as muscle spasms,||
1321|100|S|irregular heartbeat, seizures), hearing changes (such as ringing||
1321|101|S|in the ears), signs of lupus (such as rash on nose and cheeks,||
1321|102|S|new or worsening joint pain), symptoms of heart failure (such as||
1321|103|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
1321|104|S|gain), signs of kidney problems (such as change in the amount of||
1321|105|S|urine, pink/bloody urine).||
1321|106|S|   This drug may rarely cause serious (possibly fatal) liver||
1321|107|S|disease. Stop taking this medication and get medical help right||
1321|108|S|away if you have any symptoms of liver damage, including:||
1321|109|S|nausea/vomiting that doesn't stop, dark urine, yellowing||
1321|110|S|eyes/skin.||
1321|111|S|   This medication may rarely cause a severe intestinal condition||
1321|112|S|due to a bacteria called C. difficile. This condition may occur||
1321|113|S|during treatment or weeks to months after treatment has stopped.||
1321|114|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1321|115|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1321|116|S|stool.||
1321|117|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1321|118|S|products because they may make symptoms worse.||
1321|119|S|   Rarely, proton pump inhibitors (such as esomeprazole) have||
1321|120|S|caused vitamin B-12 deficiency. The risk is increased if they are||
1321|121|S|taken every day for a long time (3 years or longer). Tell your||
1321|122|S|doctor right away if you develop symptoms of vitamin B-12||
1321|123|S|deficiency (such as unusual weakness, sore tongue, or||
1321|124|S|numbness/tingling of the hands/feet).||
1321|125|S|   A very serious allergic reaction to this drug is rare.||
1321|126|S|However, get medical help right away if you notice any symptoms||
1321|127|S|of a serious allergic reaction, including: fever, swollen lymph||
1321|128|S|nodes, rash/blisters, itching/swelling (especially of the||
1321|129|S|face/tongue/throat), severe dizziness, trouble breathing.||
1321|130|S|   This is not a complete list of possible side effects. If you||
1321|131|S|notice other effects not listed above, contact your doctor or||
1321|132|S|pharmacist.||
1321|133|S|   In the US -||
1321|134|S|   Call your doctor for medical advice about side effects. You||
1321|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1321|136|S|www.fda.gov/medwatch.||
1321|137|S|   In Canada - Call your doctor for medical advice about side||
1321|138|S|effects. You may report side effects to Health Canada at||
1321|139|S|1-866-234-2345.||
1321|140|B|||
1321|141|P|PRECAUTIONS:  See also Warning section.||
1321|142|P|   Before taking naproxen/esomeprazole, tell your doctor or||
1321|143|P|pharmacist if you are allergic to either of them; or to aspirin||
1321|144|P|or other NSAIDs (such as ibuprofen, celecoxib); or to other||
1321|145|P|proton-pump inhibitors such as omeprazole, pantoprazole; or if||
1321|146|P|you have any other allergies. This product may contain inactive||
1321|147|P|ingredients, which can cause allergic reactions or other||
1321|148|P|problems. Talk to your pharmacist for more details.||
1321|149|P|   Before using this medication, tell your doctor or pharmacist||
1321|150|P|your medical history, especially of: asthma (including a history||
1321|151|P|of worsening breathing after taking aspirin or other NSAIDs),||
1321|152|P|liver disease, stomach/intestinal/esophagus problems (such as||
1321|153|P|bleeding, ulcers, recurring heartburn), heart disease (such as||
1321|154|P|history of heart attack), high blood pressure, stroke, swelling||
1321|155|P|(edema, fluid retention), low sodium blood levels, blood||
1321|156|P|disorders (such as anemia), bleeding or clotting problems,||
1321|157|P|growths in the nose (nasal polyps), lupus.||
1321|158|P|   Kidney problems can sometimes occur with the use of NSAID||
1321|159|P|medications, including naproxen. Problems are more likely to||
1321|160|P|occur if you are dehydrated, have heart failure or kidney||
1321|161|P|disease, are an older adult, or if you take certain medications||
1321|162|P|(see also Drug Interactions section). Drink plenty of fluids as||
1321|163|P|directed by your doctor to prevent dehydration and tell your||
1321|164|P|doctor right away if you have a change in the amount of urine.||
1321|165|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1321|166|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1321|167|P|machinery, or do anything that needs alertness until you can do||
1321|168|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1321|169|P|are using marijuana (cannabis).||
1321|170|P|   This medication may cause stomach bleeding. Daily use of||
1321|171|P|alcohol and tobacco, especially when combined with this medicine,||
1321|172|P|may increase the risk of stomach bleeding. Consult your doctor or||
1321|173|P|pharmacist for more information.||
1321|174|P|   This medication may make you more sensitive to the sun. Limit||
1321|175|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1321|176|P|sunscreen and wear protective clothing when outdoors. Tell your||
1321|177|P|doctor right away if you get sunburned or have skin||
1321|178|P|blisters/redness.||
1321|179|P|   Before having surgery, tell your doctor or dentist about all||
1321|180|P|the products you use (including prescription drugs,||
1321|181|P|nonprescription drugs, and herbal products).||
1321|182|P|   Proton pump inhibitors (such as esomeprazole) may increase||
1321|183|P|your risk for bone fractures, especially with longer use, higher||
1321|184|P|doses, and in older adults. Talk with your doctor or pharmacist||
1321|185|P|about ways to prevent bone loss/fracture, such as by taking||
1321|186|P|calcium (such as calcium citrate) and vitamin D supplements.||
1321|187|P|   Older adults may be at greater risk for bone loss and||
1321|188|P|fractures (see above), stomach/intestinal bleeding, kidney||
1321|189|P|problems, heart attack, stroke, and C. difficile infection while||
1321|190|P|using this drug (see Side Effects section).||
1321|191|P|   Before using this medication, women of childbearing age should||
1321|192|P|talk with their doctor(s) about the benefits and risks. Tell your||
1321|193|P|doctor if you are pregnant or if you plan to become pregnant.||
1321|194|P|This medication may harm an unborn baby and cause problems with||
1321|195|P|normal labor/delivery. It is not recommended for use in pregnancy||
1321|196|P|from 20 weeks until delivery. If your doctor decides that you||
1321|197|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1321|198|P|you should use the lowest effective dose for the shortest||
1321|199|P|possible time. You should not use this medication after 30 weeks||
1321|200|P|of pregnancy.||
1321|201|P|   Naproxen passes into breast milk. It is unknown if||
1321|202|P|esomeprazole passes into breast milk. Consult your doctor before||
1321|203|P|breastfeeding.||
1321|204|B|||
1321|205|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1321|206|I|medications work or increase your risk for serious side effects.||
1321|207|I|This document does not contain all possible drug interactions.||
1321|208|I|Keep a list of all the products you use (including||
1321|209|I|prescription/nonprescription drugs and herbal products) and share||
1321|210|I|it with your doctor and pharmacist. Do not start, stop, or change||
1321|211|I|the dosage of any medicines without your doctor's approval.||
1321|212|I|   Some products that may interact with this drug include:||
1321|213|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1321|214|I|angiotensin II receptor blockers (such as valsartan, losartan),||
1321|215|I|corticosteroids (such as prednisone), lithium, methotrexate||
1321|216|I|(especially high-dose treatment), rifampin, St John's wort,||
1321|217|I|"water pills" (diuretics such as furosemide).||
1321|218|I|   This medication may increase the risk of bleeding when taken||
1321|219|I|with other drugs that also may cause bleeding. Examples include||
1321|220|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1321|221|I|dabigatran/enoxaparin/warfarin, among others.||
1321|222|I|   Some products need stomach acid so that the body can absorb||
1321|223|I|them properly. Esomeprazole decreases stomach acid, so it may||
1321|224|I|change how well these products work. Some affected products||
1321|225|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
1321|226|I|pazopanib, rilpivirine, sparsentan, certain azole antifungals||
1321|227|I|(itraconazole, ketoconazole, posaconazole), among others.||
1321|228|I|   Check all prescription and nonprescription medicine labels||
1321|229|I|carefully since many medications contain pain relievers/fever||
1321|230|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
1321|231|I|ketorolac). These drugs are similar to naproxen and may increase||
1321|232|I|your risk of side effects if taken together. However, if your||
1321|233|I|doctor has told you to take low-dose aspirin to prevent heart||
1321|234|I|attack or stroke (usually 81-162 milligrams a day), you should||
1321|235|I|keep taking the aspirin unless your doctor tells you not to.||
1321|236|I|Daily use of naproxen may decrease aspirin's ability to prevent||
1321|237|I|heart attack/stroke. Talk with your doctor about the risks and||
1321|238|I|benefits. Ask about other medications that can be used to treat||
1321|239|I|pain/fever.||
1321|240|I|   This medication may interfere with certain lab tests, possibly||
1321|241|I|causing false test results. Make sure lab personnel and all your||
1321|242|I|doctors know you use this drug.||
1321|243|B|||
1321|244|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1321|245|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1321|246|O|poison control center right away. US residents can call||
1321|247|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1321|248|O|Symptoms of overdose may include: severe stomach pain, coffee||
1321|249|O|ground-like vomit, trouble breathing, extreme drowsiness, loss of||
1321|250|O|consciousness, seizures.||
1321|251|B|||
1321|252|N|NOTES:  Do not share this medication with others.||
1321|253|N|   Lab and/or medical tests (such as blood pressure, complete||
1321|254|N|blood count, liver/kidney function) should be done while you are||
1321|255|N|taking this medication. If you are taking this medication||
1321|256|N|regularly for a long time, magnesium and vitamin B-12 levels may||
1321|257|N|also be checked. Keep all medical and lab appointments. Consult||
1321|258|N|your doctor for more details.||
1321|259|B|||
1321|260|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1321|261|D|If it is near the time of the next dose, skip the missed dose.||
1321|262|D|Use your next dose at the regular time. Do not double the dose to||
1321|263|D|catch up.||
1321|264|B|||
1321|265|R|STORAGE:  Store at room temperature away from light and moisture.||
1321|266|R|Do not store in the bathroom. Keep all medications away from||
1321|267|R|children and pets.||
1321|268|R|   Do not flush medications down the toilet or pour them into a||
1321|269|R|drain unless instructed to do so. Properly discard this product||
1321|270|R|when it is expired or no longer needed. Consult your pharmacist||
1321|271|R|or local waste disposal company.||
1321|272|B|||
1321|273|A|Information last revised April 2025.||
1321|274|A|Copyright(c) 2025 First Databank, Inc.||
1321|275|B|||
1322|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1322|002|Z|does NOT have all possible information about this product. This||
1322|003|Z|information does not assure that this product is safe, effective,||
1322|004|Z|or appropriate for you. This information is not individual||
1322|005|Z|medical advice and does not substitute for the advice of your||
1322|006|Z|health care professional. Always ask your health care||
1322|007|Z|professional for complete information about this product and your||
1322|008|Z|specific health needs.||
1322|009|B|||
1322|010|T|COLLAGENASE CLOSTRIDIUM HISTOLYTICUM - INJECTION||
1322|011|F|(KOL-a-JEN-ase klos-TRID-ee-um HIS-toe-LIT-ik-um)||
1322|012|B|||
1322|013|C|COMMON BRAND NAME(S): Xiaflex||
1322|014|B|||
1322|015|W|WARNING:  When used to treat a certain penis condition||
1322|016|W|(Peyronie's disease), this drug has rarely caused very serious||
1322|017|W|injury to the penis (such as penile fracture/hematoma). The||
1322|018|W|injury could be permanent and/or require surgery to fix. Tell||
1322|019|W|your doctor right away if you develop symptoms of serious injury||
1322|020|W|to your penis, such as severe pain/bruising/swelling of the||
1322|021|W|penis, loss of ability to maintain an erection, difficulty||
1322|022|W|urinating, blood in the urine, or a popping sound/feeling in an||
1322|023|W|erect penis.||
1322|024|W|   To receive collagenase clostridium histolyticum for treatment||
1322|025|W|of Peyronie's disease in the United States, you must understand,||
1322|026|W|agree to, and carefully follow the requirements of the REMS||
1322|027|W|Program for this medication. If you live in Canada or any other||
1322|028|W|country, consult your doctor and pharmacist for your country's||
1322|029|W|regulations.||
1322|030|B|||
1322|031|U|USES:  This medication is used to treat certain conditions||
1322|032|U|(Dupuytren's contracture, Peyronie's disease) that are caused by||
1322|033|U|a certain protein (collagen) in your body. Collagen is a tough||
1322|034|U|and strong substance and is found in the knots/cords of the hand||
1322|035|U|in Dupuytren's contracture or plaques in the penis in Peyronie's||
1322|036|U|disease. Collagenase is a substance (enzyme) that breaks down the||
1322|037|U|collagen in these knots/cords/plaques.||
1322|038|B|||
1322|039|H|HOW TO USE:  Read the Medication Guide provided by your||
1322|040|H|healthcare professional before each injection. If you have any||
1322|041|H|questions, ask your doctor or pharmacist.||
1322|042|H|   If you are using this medication to treat Dupuytren's||
1322|043|H|contracture, the medication is injected into the tissue knot||
1322|044|H|(cord) of the affected hand by your healthcare provider. Your||
1322|045|H|hand will be wrapped in soft gauze after the injection. Limit||
1322|046|H|hand movement and keep the hand elevated until bedtime. Do not||
1322|047|H|try to straighten, curl, or move the injected finger until your||
1322|048|H|doctor tells you it is okay to do so. Tell your doctor right away||
1322|049|H|if you start to feel numbness, tingling, or a feeling of "pins||
1322|050|H|and needles" in your hand during the procedure.||
1322|051|H|   You must return to your doctor's office within 1 to 3 days||
1322|052|H|after the procedure. Your doctor will check your hand, try to||
1322|053|H|straighten the finger if needed, and apply a splint. Wear the||
1322|054|H|splint every night at bedtime as long as directed by your doctor||
1322|055|H|(for up to 4 months). Do finger exercises several times a day||
1322|056|H|exactly as directed. Do not do any strenuous activity with the||
1322|057|H|treated hand until your doctor tells you it is okay to do so.||
1322|058|H|Tell your doctor if you have trouble bending the finger after the||
1322|059|H|swelling goes down or problems using your hand.||
1322|060|H|   If you are still unable to straighten your finger after 4||
1322|061|H|weeks, your doctor may give a repeat injection into the same area||
1322|062|H|of the hand. No more than 3 injections, each 4 weeks apart,||
1322|063|H|should be given in the same area.||
1322|064|H|   If you are using this medication to treat Peyronie's disease,||
1322|065|H|the medication is injected into the plaque in the penis by your||
1322|066|H|healthcare provider. Each treatment cycle consists of two||
1322|067|H|injections 1 to 3 days apart and a modeling (straightening)||
1322|068|H|procedure 1 to 3 days after the second injection. Do not have sex||
1322|069|H|between the first and second injections of a treatment cycle.||
1322|070|H|Also, do not have any sexual activity for at least 4 weeks after||
1322|071|H|the second injection of a treatment cycle and only after your||
1322|072|H|doctor says that it is safe to do so (usually after all the||
1322|073|H|pain/swelling has gone away). You might have as many as 4||
1322|074|H|treatment cycles. Each treatment cycle is about 6 weeks apart. In||
1322|075|H|between cycles, follow your doctor's instructions on||
1322|076|H|straightening and stretching the penis. Tell your doctor if you||
1322|077|H|have trouble stretching or straightening your penis or if new||
1322|078|H|pain occurs.||
1322|079|B|||
1322|080|S|SIDE EFFECTS:  See also How to Use and Warning sections.||
1322|081|S|   Pain, swelling, bruising, bleeding, redness, itching at or||
1322|082|S|around the injection site may occur. Swollen, painful areas in||
1322|083|S|the elbow and underarm (swollen lymph nodes) may also occur when||
1322|084|S|this medication is injected in the hand. If any of these effects||
1322|085|S|last or get worse, tell your doctor promptly.||
1322|086|S|   Tell your doctor right away if you have dizziness or feel||
1322|087|S|faint. Sitting or lying down may help.||
1322|088|S|   Remember that this medication has been prescribed because your||
1322|089|S|doctor has judged that the benefit to you is greater than the||
1322|090|S|risk of side effects. Many people using this medication do not||
1322|091|S|have serious side effects.||
1322|092|S|   If treating Dupuytren's contracture, tell your doctor right||
1322|093|S|away if you have any serious side effects, including: signs of||
1322|094|S|infection (such as sore throat that doesn't go away, fever,||
1322|095|S|chills, increasing redness/swelling), signs of nerve injury (such||
1322|096|S|as numbness/tingling/pain/strange feeling in the treated hand),||
1322|097|S|tears in the skin around the injection site (lacerations).||
1322|098|S|   Serious (possibly permanent) injury to the tendons/ligaments||
1322|099|S|of the hand is a rare side effect of this drug/procedure. The||
1322|100|S|injury may require surgery to repair. Tell your doctor right away||
1322|101|S|if you have difficulty moving your fingers or hand after your||
1322|102|S|doctor has told you it is okay to move them.||
1322|103|S|   Some people using this medication for Peyronie's disease have||
1322|104|S|developed lower back pain soon after receiving an injection. Tell||
1322|105|S|your doctor right away if you have sudden lower back pain or back||
1322|106|S|pain that spreads to your legs, feet, arms, or chest. The back||
1322|107|S|pain may also include spasms and make it hard to walk. These||
1322|108|S|symptoms usually go away after 15 minutes but may last longer.||
1322|109|S|   A very serious allergic reaction to this drug is rare.||
1322|110|S|However, get medical help right away if you notice any symptoms||
1322|111|S|of a serious allergic reaction, including: rash, itching/swelling||
1322|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1322|113|S|breathing.||
1322|114|S|   This is not a complete list of possible side effects. If you||
1322|115|S|notice other effects not listed above, contact your doctor or||
1322|116|S|pharmacist.||
1322|117|S|   In the US -||
1322|118|S|   Call your doctor for medical advice about side effects. You||
1322|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1322|120|S|www.fda.gov/medwatch.||
1322|121|S|   In Canada - Call your doctor for medical advice about side||
1322|122|S|effects. You may report side effects to Health Canada at||
1322|123|S|1-866-234-2345.||
1322|124|B|||
1322|125|P|PRECAUTIONS:  Before using collagenase, tell your doctor or||
1322|126|P|pharmacist if you are allergic to it; or if you have any other||
1322|127|P|allergies. This product may contain inactive ingredients, which||
1322|128|P|can cause allergic reactions or other problems. Talk to your||
1322|129|P|pharmacist for more details.||
1322|130|P|   Before using this medication, tell your doctor or pharmacist||
1322|131|P|your medical history, especially of: bleeding/clotting problems.||
1322|132|P|   If you are using this medication to treat Peyronie's disease,||
1322|133|P|do not use a vacuum erection device during your treatment with||
1322|134|P|this medication. Also, avoid straining your stomach/abdominal||
1322|135|P|muscles, such as straining during bowel movements.||
1322|136|P|   Before having surgery, tell your doctor or dentist about all||
1322|137|P|the products you use (including prescription drugs,||
1322|138|P|nonprescription drugs, and herbal products).||
1322|139|P|   Tell your doctor if you are pregnant before using this||
1322|140|P|medication.||
1322|141|P|   It is unknown if this medication passes into breast milk.||
1322|142|P|Consult your doctor before breastfeeding.||
1322|143|B|||
1322|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1322|145|I|medications work or increase your risk for serious side effects.||
1322|146|I|This document does not contain all possible drug interactions.||
1322|147|I|Keep a list of all the products you use (including||
1322|148|I|prescription/nonprescription drugs and herbal products) and share||
1322|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
1322|150|I|the dosage of any medicines without your doctor's approval.||
1322|151|I|   Some products that may interact with this drug include: drugs||
1322|152|I|that can cause bleeding/bruising (including aspirin, antiplatelet||
1322|153|I|drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood||
1322|154|I|thinners" such as warfarin).||
1322|155|I|   Your doctor may tell you to stop taking these medications 7||
1322|156|I|days before your injection. If so, ask your doctor when it is||
1322|157|I|safe to start taking them again.||
1322|158|I|   If your doctor has told you to take low-dose aspirin to||
1322|159|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
1322|160|I|you should keep taking the aspirin unless your doctor tells you||
1322|161|I|not to. Ask your doctor or pharmacist for more details.||
1322|162|B|||
1322|163|O|OVERDOSE:  Not applicable.||
1322|164|B|||
1322|165|N|NOTES:  Keep all medical and lab appointments.||
1322|166|B|||
1322|167|D|MISSED DOSE:  It is important to get each dose of this medication||
1322|168|D|as scheduled. If you miss a dose, ask your doctor right away for||
1322|169|D|a new dosing schedule.||
1322|170|B|||
1322|171|R|STORAGE:  Not applicable. This medication is given in a doctor's||
1322|172|R|office and will not be stored at home.||
1322|173|B|||
1322|174|A|Information last revised April 2025.||
1322|175|A|Copyright(c) 2025 First Databank, Inc.||
1322|176|B|||
1323|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1323|002|Z|does NOT have all possible information about this product. This||
1323|003|Z|information does not assure that this product is safe, effective,||
1323|004|Z|or appropriate for you. This information is not individual||
1323|005|Z|medical advice and does not substitute for the advice of your||
1323|006|Z|health care professional. Always ask your health care||
1323|007|Z|professional for complete information about this product and your||
1323|008|Z|specific health needs.||
1323|009|B|||
1323|010|T|PITAVASTATIN - ORAL||
1323|011|F|(pit-A-va-STAT-in)||
1323|012|B|||
1323|013|C|COMMON BRAND NAME(S): Livalo, Zypitamag||
1323|014|B|||
1323|015|U|USES:  Pitavastatin is used along with a proper diet to help||
1323|016|U|lower "bad" cholesterol and fats (such as LDL, triglycerides) and||
1323|017|U|raise "good" cholesterol (HDL) in the blood. It belongs to a||
1323|018|U|group of drugs known as "statins." It works by reducing the||
1323|019|U|amount of cholesterol made by the liver. Lowering "bad"||
1323|020|U|cholesterol and triglycerides and raising "good" cholesterol||
1323|021|U|decreases the risk of heart disease and helps prevent strokes and||
1323|022|U|heart attacks.||
1323|023|U|   In addition to eating a proper diet (such as a||
1323|024|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
1323|025|U|help this medication work better include exercising, losing||
1323|026|U|weight if overweight, and stopping smoking. Consult your doctor||
1323|027|U|for more details.||
1323|028|B|||
1323|029|H|HOW TO USE:  Take this medication by mouth with or without food||
1323|030|H|as directed by your doctor, usually once daily.||
1323|031|H|   The dosage is based on your medical condition, response to||
1323|032|H|treatment, and other medications you may be taking. Be sure to||
1323|033|H|tell your doctor and pharmacist about all the products you use||
1323|034|H|(including prescription drugs, nonprescription drugs, and herbal||
1323|035|H|products).||
1323|036|H|   If you also take certain other drugs to lower your cholesterol||
1323|037|H|(bile acid-binding resins such as cholestyramine or colestipol),||
1323|038|H|take pitavastatin at least 1 hour before or at least 4 hours||
1323|039|H|after taking these medications. These products can react with||
1323|040|H|pitavastatin, preventing its full absorption.||
1323|041|H|   Take this medication regularly in order to get the most||
1323|042|H|benefit from it. Remember to take it at the same time each day.||
1323|043|H|Keep taking this medication even if you feel well. Most people||
1323|044|H|with high cholesterol or triglycerides do not feel sick.||
1323|045|H|   It is very important to continue to follow your doctor's||
1323|046|H|advice about diet and exercise. It may take up to 4 weeks before||
1323|047|H|you get the full benefit of this drug.||
1323|048|B|||
1323|049|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1323|050|S|because your doctor has judged that the benefit to you is greater||
1323|051|S|than the risk of side effects. Many people using this medication||
1323|052|S|do not have serious side effects.||
1323|053|S|   A very small number of people taking pitavastatin may have||
1323|054|S|mild memory problems or confusion. If these rare effects occur,||
1323|055|S|talk to your doctor.||
1323|056|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
1323|057|S|doctor about the benefits and risks.||
1323|058|S|   This drug may rarely cause muscle problems (which can rarely||
1323|059|S|lead to very serious conditions called rhabdomyolysis and||
1323|060|S|autoimmune myopathy). Tell your doctor right away if you develop||
1323|061|S|any of these symptoms during treatment and if these symptoms last||
1323|062|S|after your doctor stops this drug: muscle||
1323|063|S|pain/tenderness/weakness (especially with fever or unusual||
1323|064|S|tiredness), signs of kidney problems (such as change in the||
1323|065|S|amount of urine).||
1323|066|S|   This medication may rarely cause liver problems. Tell your||
1323|067|S|doctor right away if you develop symptoms of liver problems,||
1323|068|S|including: nausea/vomiting that doesn't stop, stomach/abdominal||
1323|069|S|pain, yellowing eyes/skin, dark urine.||
1323|070|S|   A very serious allergic reaction to this drug is rare.||
1323|071|S|However, get medical help right away if you notice any symptoms||
1323|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1323|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1323|074|S|breathing.||
1323|075|S|   This is not a complete list of possible side effects. If you||
1323|076|S|notice other effects not listed above, contact your doctor or||
1323|077|S|pharmacist.||
1323|078|S|   In the US -||
1323|079|S|   Call your doctor for medical advice about side effects. You||
1323|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1323|081|S|www.fda.gov/medwatch.||
1323|082|S|   In Canada - Call your doctor for medical advice about side||
1323|083|S|effects. You may report side effects to Health Canada at||
1323|084|S|1-866-234-2345.||
1323|085|B|||
1323|086|P|PRECAUTIONS:  Before taking pitavastatin, tell your doctor or||
1323|087|P|pharmacist if you are allergic to it; or if you have any other||
1323|088|P|allergies. This product may contain inactive ingredients, which||
1323|089|P|can cause allergic reactions or other problems. Talk to your||
1323|090|P|pharmacist for more details.||
1323|091|P|   Before using this medication, tell your doctor or pharmacist||
1323|092|P|your medical history, especially of: liver disease, kidney||
1323|093|P|disease, alcohol use.||
1323|094|P|   Before having surgery, tell your doctor or dentist about all||
1323|095|P|the products you use (including prescription drugs,||
1323|096|P|nonprescription drugs, and herbal products).||
1323|097|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
1323|098|P|your risk for liver problems, especially when combined with||
1323|099|P|pitavastatin. Ask your doctor or pharmacist for more information.||
1323|100|P|   Older adults may be more sensitive to the side effects of this||
1323|101|P|drug, especially muscle problems.||
1323|102|P|   During pregnancy, this medication should be used only when||
1323|103|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1323|104|P|benefits with your doctor.||
1323|105|P|   It is unknown if this medication passes into breast milk.||
1323|106|P|Because of the possible risk to the infant, breastfeeding is not||
1323|107|P|recommended while using this medication. Consult your doctor||
1323|108|P|before breastfeeding.||
1323|109|B|||
1323|110|I|DRUG INTERACTIONS:  See also How to Use section.||
1323|111|I|   Drug interactions may change how your medications work or||
1323|112|I|increase your risk for serious side effects. This document does||
1323|113|I|not contain all possible drug interactions. Keep a list of all||
1323|114|I|the products you use (including prescription/nonprescription||
1323|115|I|drugs and herbal products) and share it with your doctor and||
1323|116|I|pharmacist. Do not start, stop, or change the dosage of any||
1323|117|I|medicines without your doctor's approval.||
1323|118|I|   Some products that may interact with this drug include:||
1323|119|I|colchicine, daptomycin, gemfibrozil.||
1323|120|I|   Other medications can affect the removal of pitavastatin from||
1323|121|I|your body, which may affect how pitavastatin works. Examples||
1323|122|I|include cyclosporine, letermovir,||
1323|123|I|sofosbuvir/velpatasvir/voxilaprevir, among others.||
1323|124|I|   Do not take any red yeast rice products while you are taking||
1323|125|I|pitavastatin because some red yeast rice products may also||
1323|126|I|contain a statin called lovastatin. Taking pitavastatin and red||
1323|127|I|yeast rice products together can increase your risk of serious||
1323|128|I|muscle and liver problems.||
1323|129|B|||
1323|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1323|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1323|132|O|poison control center right away. US residents can call||
1323|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1323|134|B|||
1323|135|N|NOTES:  Do not share this medication with others.||
1323|136|N|   Lab and/or medical tests (such as blood||
1323|137|N|cholesterol/triglyceride levels, liver function) should be done||
1323|138|N|while you are taking this medication. Keep all medical and lab||
1323|139|N|appointments. Consult your doctor for more details.||
1323|140|B|||
1323|141|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1323|142|D|remember. If it is near the time of the next dose, skip the||
1323|143|D|missed dose. Take your next dose at the regular time. Do not||
1323|144|D|double the dose to catch up.||
1323|145|B|||
1323|146|R|STORAGE:  Store at room temperature away from light and moisture.||
1323|147|R|Do not store in the bathroom. Keep all medications away from||
1323|148|R|children and pets.||
1323|149|R|   Do not flush medications down the toilet or pour them into a||
1323|150|R|drain unless instructed to do so. Properly discard this product||
1323|151|R|when it is expired or no longer needed. Consult your pharmacist||
1323|152|R|or local waste disposal company.||
1323|153|B|||
1323|154|A|Information last revised May 2024.||
1323|155|A|Copyright(c) 2025 First Databank, Inc.||
1323|156|B|||
1324|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1324|002|Z|does NOT have all possible information about this product. This||
1324|003|Z|information does not assure that this product is safe, effective,||
1324|004|Z|or appropriate for you. This information is not individual||
1324|005|Z|medical advice and does not substitute for the advice of your||
1324|006|Z|health care professional. Always ask your health care||
1324|007|Z|professional for complete information about this product and your||
1324|008|Z|specific health needs.||
1324|009|B|||
1324|010|T|CLOTRIMAZOLE CREAM AND FLUCONAZOLE CAPSULE - KIT||
1324|011|F|(kloe-TRIM-a-zole/floo-KON-a-zole)||
1324|012|B|||
1324|013|U|USES:  This kit contains 2 medications: one fluconazole capsule||
1324|014|U|and a tube of clotrimazole cream. Fluconazole is an azole||
1324|015|U|antifungal taken by mouth to treat vaginal yeast infections. The||
1324|016|U|clotrimazole cream is also an azole antifungal. It is used on the||
1324|017|U|skin in and around the vaginal area to reduce symptoms such as||
1324|018|U|burning, itching, and redness that may occur with a vaginal yeast||
1324|019|U|infection. Both medications work by stopping the growth of yeast||
1324|020|U|(fungus) that causes the infection.||
1324|021|U|   Ask your doctor before using this medication for||
1324|022|U|self-treatment if this is your first vaginal infection. This||
1324|023|U|product only works for vaginal yeast infections. You may have a||
1324|024|U|different type of infection (such as bacterial vaginosis) and may||
1324|025|U|need a different medication.||
1324|026|U|   If you have fever, chills, flu-like symptoms,||
1324|027|U|stomach/abdominal pain, or a bad-smelling vaginal discharge, do||
1324|028|U|not use this medication. Contact your doctor right away because||
1324|029|U|these may be signs of a more serious infection.||
1324|030|B|||
1324|031|H|HOW TO USE:  If you are using the over-the counter product to||
1324|032|H|self-treat, read and follow all directions on the product package||
1324|033|H|before using this medication. If your doctor has prescribed this||
1324|034|H|medication, follow your doctor's directions. Read the Patient||
1324|035|H|Information Leaflet available with this product. Ask your doctor||
1324|036|H|or pharmacist if you have any questions.||
1324|037|H|   Take the fluconazole capsule by mouth with or without food as||
1324|038|H|directed by your doctor, usually as a one-time only dose.||
1324|039|H|   If you have itching/burning in or around the vaginal area,||
1324|040|H|apply a small amount of the cream to that area usually once or||
1324|041|H|twice daily for no more than 7 days. Wash your hands before and||
1324|042|H|after use. Avoid contact of this product with your eyes. If it||
1324|043|H|gets into your eyes, wash them right away with plenty of water.||
1324|044|H|Call your doctor if eye irritation lasts.||
1324|045|H|   You should see some improvement in your symptoms within 1 day||
1324|046|H|of taking the fluconazole. Tell your doctor if your condition||
1324|047|H|does not get better after 3 days or lasts more than 7 days, or if||
1324|048|H|your infection returns within 2 months. You may need a different||
1324|049|H|or additional medication to treat your infection.||
1324|050|B|||
1324|051|S|SIDE EFFECTS:  Nausea, stomach/abdominal pain, dizziness, or||
1324|052|S|headache may occur with fluconazole. Clotrimazole cream may cause||
1324|053|S|temporary burning, itching, or redness. If any of these effects||
1324|054|S|last or get worse, tell your doctor or pharmacist promptly.||
1324|055|S|   If your doctor has directed you to use this medication,||
1324|056|S|remember that your doctor has judged that the benefit to you is||
1324|057|S|greater than the risk of side effects. Many people using this||
1324|058|S|medication do not have serious side effects.||
1324|059|S|   Get medical help right away if you have any very serious side||
1324|060|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1324|061|S|fainting.||
1324|062|S|   A very serious allergic reaction to this drug is rare.||
1324|063|S|However, get medical help right away if you notice any symptoms||
1324|064|S|of a serious allergic reaction, including: fever, swollen lymph||
1324|065|S|nodes, rash, itching/swelling (especially of the||
1324|066|S|face/tongue/throat), severe dizziness, trouble breathing.||
1324|067|S|   This is not a complete list of possible side effects. If you||
1324|068|S|notice other effects not listed above, contact your doctor or||
1324|069|S|pharmacist.||
1324|070|S|   In the US -||
1324|071|S|   Call your doctor for medical advice about side effects. You||
1324|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1324|073|S|www.fda.gov/medwatch.||
1324|074|S|   In Canada - Call your doctor for medical advice about side||
1324|075|S|effects. You may report side effects to Health Canada at||
1324|076|S|1-866-234-2345.||
1324|077|B|||
1324|078|P|PRECAUTIONS:  Before using fluconazole or clotrimazole, tell your||
1324|079|P|doctor or pharmacist if you are allergic to either of them; or to||
1324|080|P|other azole antifungal drugs (such as ketoconazole,||
1324|081|P|itraconazole); or if you have any other allergies. This product||
1324|082|P|may contain inactive ingredients, which can cause allergic||
1324|083|P|reactions or other problems. Talk to your pharmacist for more||
1324|084|P|details.||
1324|085|P|   Before using this medication, tell your doctor or pharmacist||
1324|086|P|your medical history, especially of: liver disease, kidney||
1324|087|P|disease.||
1324|088|P|   Fluconazole may cause a condition that affects the heart||
1324|089|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1324|090|P|serious (rarely fatal) fast/irregular heartbeat and other||
1324|091|P|symptoms (such as severe dizziness, fainting) that need medical||
1324|092|P|attention right away.||
1324|093|P|   The risk of QT prolongation may be increased if you have||
1324|094|P|certain medical conditions or are taking other drugs that may||
1324|095|P|cause QT prolongation. Before using fluconazole, tell your doctor||
1324|096|P|or pharmacist of all the drugs you take and if you have any of||
1324|097|P|the following conditions: certain heart problems (heart failure,||
1324|098|P|slow heartbeat, QT prolongation in the EKG), family history of||
1324|099|P|certain heart problems (QT prolongation in the EKG, sudden||
1324|100|P|cardiac death).||
1324|101|P|   Low levels of potassium or magnesium in the blood may also||
1324|102|P|increase your risk of QT prolongation. This risk may increase if||
1324|103|P|you use certain drugs (such as diuretics/"water pills") or if you||
1324|104|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1324|105|P|Talk to your doctor about using fluconazole safely.||
1324|106|P|   This drug may rarely make you dizzy. Alcohol or marijuana||
1324|107|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
1324|108|P|or do anything that needs alertness until you can do it safely.||
1324|109|P|Limit alcoholic beverages. Talk to your doctor if you are using||
1324|110|P|marijuana (cannabis).||
1324|111|P|   Before having surgery, tell your doctor or dentist about all||
1324|112|P|the products you use (including prescription drugs,||
1324|113|P|nonprescription drugs, and herbal products).||
1324|114|P|   Older adults may be more sensitive to the side effects of this||
1324|115|P|drug, especially QT prolongation (see above).||
1324|116|P|   During pregnancy, this medication should be used only when||
1324|117|P|clearly needed. Clotrimazole cream may decrease the effectiveness||
1324|118|P|of latex condoms and diaphragms during treatment and for 3 days||
1324|119|P|after last use. Fluconazole may harm an unborn baby if taken||
1324|120|P|during the first 3 months of pregnancy. Discuss the risks and||
1324|121|P|benefits with your doctor.||
1324|122|P|   Fluconazole passes into breast milk. It is unknown if||
1324|123|P|clotrimazole passes into breast milk. However, it is unlikely to||
1324|124|P|pass into breast milk in large amounts. Consult your doctor||
1324|125|P|before breastfeeding.||
1324|126|B|||
1324|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1324|128|I|medications work or increase your risk for serious side effects.||
1324|129|I|This document does not contain all possible drug interactions.||
1324|130|I|Keep a list of all the products you use (including||
1324|131|I|prescription/nonprescription drugs and herbal products) and share||
1324|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
1324|133|I|the dosage of any medicines without your doctor's approval.||
1324|134|I|   A product that may interact with this drug is: clopidogrel.||
1324|135|I|   Many drugs besides fluconazole may affect the heart rhythm (QT||
1324|136|I|prolongation), including pimozide, quinidine, macrolide||
1324|137|I|antibiotics (such as erythromycin), among others.||
1324|138|I|   Fluconazole can slow down the removal of other medications||
1324|139|I|from your body, which can affect how they work. Examples of||
1324|140|I|affected drugs include abrocitinib, deuruxolitinib, domperidone,||
1324|141|I|flibanserin, lemborexant, macitentan, mavacamten, nirogacestat,||
1324|142|I|rilzabrutinib, taletrectinib, among others.||
1324|143|B|||
1324|144|O|OVERDOSE:  The cream may be harmful if swallowed. If someone has||
1324|145|O|overdosed and has serious symptoms such as passing out or trouble||
1324|146|O|breathing, call 911. Otherwise, call a poison control center||
1324|147|O|right away. US residents can call 1-800-222-1222. Canada||
1324|148|O|residents can call 1-844-764-7669.||
1324|149|B|||
1324|150|N|NOTES:  If your doctor has directed you to use this medication,||
1324|151|N|use it for your current condition only. Do not use it later for||
1324|152|N|another infection unless your doctor tells you to.||
1324|153|N|   To help prevent vaginal yeast infections, dry the genital area||
1324|154|N|thoroughly after showering, bathing, or swimming. Avoid wearing||
1324|155|N|tight jeans, nylon underwear, pantyhose, a wet bathing suit, or||
1324|156|N|damp/sweaty exercise clothes for long periods. Wear cotton||
1324|157|N|underwear, and change your underwear daily.||
1324|158|B|||
1324|159|D|MISSED DOSE:  If you are prescribed more than one dose and you||
1324|160|D|miss it, contact your doctor for instructions.||
1324|161|B|||
1324|162|R|STORAGE:  Store the capsule at room temperature away from light||
1324|163|R|and moisture. Do not store in the bathroom. Store the cream at||
1324|164|R|room temperature. Keep all medications away from children and||
1324|165|R|pets.||
1324|166|R|   Do not flush medications down the toilet or pour them into a||
1324|167|R|drain unless instructed to do so. Properly discard this product||
1324|168|R|when it is expired or no longer needed. Consult your pharmacist||
1324|169|R|or local waste disposal company.||
1324|170|B|||
1324|171|A|Information last revised November 2025.||
1324|172|A|Copyright(c) 2025 First Databank, Inc.||
1324|173|B|||
1325|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1325|002|Z|does NOT have all possible information about this product. This||
1325|003|Z|information does not assure that this product is safe, effective,||
1325|004|Z|or appropriate for you. This information is not individual||
1325|005|Z|medical advice and does not substitute for the advice of your||
1325|006|Z|health care professional. Always ask your health care||
1325|007|Z|professional for complete information about this product and your||
1325|008|Z|specific health needs.||
1325|009|B|||
1325|010|T|KETOROLAC 0.45% PRESERVATIVE-FREE SOLUTION - OPHTHALMIC||
1325|011|F|(KEE-toe-ROLE-ak)||
1325|012|B|||
1325|013|C|COMMON BRAND NAME(S): Acuvail||
1325|014|B|||
1325|015|U|USES:  This medication is used to treat eye pain and swelling||
1325|016|U|(inflammation) after cataract surgery. Ketorolac belongs to a||
1325|017|U|class of drugs known as nonsteroidal anti-inflammatory drugs||
1325|018|U|(NSAIDs). It works by blocking certain natural substances in your||
1325|019|U|body to reduce pain and swelling.||
1325|020|B|||
1325|021|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1325|022|H|directed by your doctor, usually twice daily starting 1 day||
1325|023|H|before surgery, continuing on the day of surgery, and then for 2||
1325|024|H|weeks after surgery.||
1325|025|H|   To apply eye medication, wash your hands first. To avoid||
1325|026|H|contamination, do not touch the dropper tip or let it touch your||
1325|027|H|eye or any other surface.||
1325|028|H|   Do not wear contact lenses while using this medication.||
1325|029|H|Sterilize contact lenses according to the manufacturer's||
1325|030|H|directions, and check with your doctor before you begin using||
1325|031|H|them again.||
1325|032|H|   Tilt your head back, look upward, and pull down the lower||
1325|033|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1325|034|H|and place one drop into the pouch. Look downward, gently close||
1325|035|H|your eyes, and place one finger at the corner of your eye (near||
1325|036|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
1325|037|H|opening your eyes. This will prevent the medication from draining||
1325|038|H|out. Try not to blink or rub your eye.||
1325|039|H|   For single-use vials, open the vial right before use. After||
1325|040|H|use, discard any remaining solution right away. Do not keep an||
1325|041|H|opened vial for later use.||
1325|042|H|   If you are using another kind of eye medication (such as drops||
1325|043|H|or ointments), wait at least 5 minutes between applying each||
1325|044|H|medication. Use eye drops before eye ointments to allow the drops||
1325|045|H|to enter the eye.||
1325|046|H|   Wait several minutes for your vision to clear before driving||
1325|047|H|or operating machinery.||
1325|048|H|   Do not use this medication more often or for longer than||
1325|049|H|directed by your doctor. This medication is usually used only for||
1325|050|H|a short time. Prolonged use may slow or delay healing and may||
1325|051|H|increase your chance of serious side effects.||
1325|052|H|   Tell your doctor if your condition lasts or if it gets worse||
1325|053|H|(for example, you develop worsening eye pain/itching/swelling).||
1325|054|B|||
1325|055|S|SIDE EFFECTS:  This medication may sting or burn your eyes for||
1325|056|S|1-2 minutes when applied. If any of these effects last or get||
1325|057|S|worse, tell your doctor or pharmacist promptly.||
1325|058|S|   Remember that this medication has been prescribed because your||
1325|059|S|doctor has judged that the benefit to you is greater than the||
1325|060|S|risk of side effects. Many people using this medication do not||
1325|061|S|have serious side effects.||
1325|062|S|   Tell your doctor right away if you have any serious side||
1325|063|S|effects, including: eye pain/swelling, vision changes (such as||
1325|064|S|decreased vision), bleeding inside the eye.||
1325|065|S|   A very serious allergic reaction to this drug is rare.||
1325|066|S|However, get medical help right away if you notice any symptoms||
1325|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1325|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1325|069|S|breathing.||
1325|070|S|   This is not a complete list of possible side effects. If you||
1325|071|S|notice other effects not listed above, contact your doctor or||
1325|072|S|pharmacist.||
1325|073|S|   In the US -||
1325|074|S|   Call your doctor for medical advice about side effects. You||
1325|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1325|076|S|www.fda.gov/medwatch.||
1325|077|S|   In Canada - Call your doctor for medical advice about side||
1325|078|S|effects. You may report side effects to Health Canada at||
1325|079|S|1-866-234-2345.||
1325|080|B|||
1325|081|P|PRECAUTIONS:  Before using ketorolac, tell your doctor or||
1325|082|P|pharmacist if you are allergic to it; or to aspirin; or to other||
1325|083|P|NSAIDs (such as ibuprofen, celecoxib); or if you have any other||
1325|084|P|allergies. This product may contain inactive ingredients, which||
1325|085|P|can cause allergic reactions or other problems. Talk to your||
1325|086|P|pharmacist for more details.||
1325|087|P|   Before using this medication, tell your doctor or pharmacist||
1325|088|P|your medical history, especially of: asthma (including a history||
1325|089|P|of worsening breathing after taking aspirin or other NSAIDs),||
1325|090|P|bleeding problems, recent multiple eye surgeries, other eye||
1325|091|P|problems (such as dry eye syndrome, cornea problems), diabetes,||
1325|092|P|rheumatoid arthritis, nasal polyps.||
1325|093|P|   After you apply this drug, your vision may become temporarily||
1325|094|P|blurred or unstable. Do not drive, use machinery, or do anything||
1325|095|P|that needs clear vision until you can do it safely.||
1325|096|P|   If you develop an eye infection or injury, ask your doctor if||
1325|097|P|you should continue to use this medication.||
1325|098|P|   Before having surgery, tell your doctor or dentist about all||
1325|099|P|the products you use (including prescription drugs,||
1325|100|P|nonprescription drugs, and herbal products).||
1325|101|P|   During pregnancy, this medication should be used only when||
1325|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
1325|103|P|   It is unknown if this drug passes into breast milk, but it is||
1325|104|P|unlikely to harm a nursing infant. Consult your doctor before||
1325|105|P|breastfeeding.||
1325|106|B|||
1325|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1325|108|I|medications work or increase your risk for serious side effects.||
1325|109|I|This document does not contain all possible drug interactions.||
1325|110|I|Keep a list of all the products you use (including||
1325|111|I|prescription/nonprescription drugs and herbal products) and share||
1325|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
1325|113|I|the dosage of any medicines without your doctor's approval.||
1325|114|I|   Some products that may interact with this drug are:||
1325|115|I|corticosteroids (such as prednisone).||
1325|116|I|   This medication may increase the risk of bleeding when used||
1325|117|I|with other drugs that also may cause bleeding. Examples include||
1325|118|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1325|119|I|dabigatran/enoxaparin/warfarin, among others.||
1325|120|I|   Check all prescription and nonprescription medicine labels||
1325|121|I|carefully since many medications contain pain relievers/fever||
1325|122|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These||
1325|123|I|drugs are similar to ketorolac and may increase your risk of side||
1325|124|I|effects if taken together. However, if your doctor has told you||
1325|125|I|to take low-dose aspirin to prevent heart attack or stroke||
1325|126|I|(usually 81-162 milligrams a day), you should keep taking the||
1325|127|I|aspirin unless your doctor tells you not to. Ask your doctor or||
1325|128|I|pharmacist for more details.||
1325|129|B|||
1325|130|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1325|131|O|has overdosed and has serious symptoms such as passing out or||
1325|132|O|trouble breathing, call 911. Otherwise, call a poison control||
1325|133|O|center right away. US residents can call 1-800-222-1222. Canada||
1325|134|O|residents can call 1-844-764-7669.||
1325|135|B|||
1325|136|N|NOTES:  Do not share this medication with others.||
1325|137|N|   This medication has been prescribed for your current condition||
1325|138|N|only. Do not use it later for another eye condition unless told||
1325|139|N|to do so by your doctor. A different medication may be necessary||
1325|140|N|in that case.||
1325|141|N|   Lab and/or medical tests (such as eye exams) should be done||
1325|142|N|while you are using this medication. Keep all medical and lab||
1325|143|N|appointments. Consult your doctor for more details.||
1325|144|B|||
1325|145|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1325|146|D|If it is near the time of the next dose, skip the missed dose.||
1325|147|D|Use your next dose at the regular time. Do not double the dose to||
1325|148|D|catch up.||
1325|149|B|||
1325|150|R|STORAGE:  Store at room temperature away from light. Store the||
1325|151|R|single-use vials in the pouch provided and fold the pouch ends||
1325|152|R|closed. Keep all medications away from children and pets.||
1325|153|R|   Do not flush medications down the toilet or pour them into a||
1325|154|R|drain unless instructed to do so. Properly discard this product||
1325|155|R|when it is expired or no longer needed. Consult your pharmacist||
1325|156|R|or local waste disposal company.||
1325|157|B|||
1325|158|A|Information last revised November 2024.||
1325|159|A|Copyright(c) 2025 First Databank, Inc.||
1325|160|B|||
1326|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1326|002|Z|does NOT have all possible information about this product. This||
1326|003|Z|information does not assure that this product is safe, effective,||
1326|004|Z|or appropriate for you. This information is not individual||
1326|005|Z|medical advice and does not substitute for the advice of your||
1326|006|Z|health care professional. Always ask your health care||
1326|007|Z|professional for complete information about this product and your||
1326|008|Z|specific health needs.||
1326|009|B|||
1326|010|T|VORICONAZOLE SUSPENSION - ORAL||
1326|011|F|(VOR-i-KON-a-zole)||
1326|012|B|||
1326|013|C|COMMON BRAND NAME(S): Vfend||
1326|014|B|||
1326|015|U|USES:  Voriconazole is used to treat a variety of fungal||
1326|016|U|infections. It belongs to a class of drugs known as azole||
1326|017|U|antifungals. It works by stopping the growth of fungi.||
1326|018|B|||
1326|019|H|HOW TO USE:  Read the Patient Information Leaflet and||
1326|020|H|Instructions for Use if available from your pharmacist before you||
1326|021|H|start taking voriconazole and each time you get a refill. If you||
1326|022|H|have any questions, ask your doctor or pharmacist.||
1326|023|H|   Take this medication by mouth without food (at least 1 hour||
1326|024|H|before or 1 hour after meals) as directed by your doctor, usually||
1326|025|H|every 12 hours.||
1326|026|H|   Shake the bottle well before each dose. Carefully measure the||
1326|027|H|dose using the special measuring device provided. Do not use a||
1326|028|H|household spoon because you may not get the correct dose.||
1326|029|H|   The dosage and length of treatment are based on your medical||
1326|030|H|condition, weight, response to treatment, and other medications||
1326|031|H|you may be taking. Be sure to tell your doctor and pharmacist||
1326|032|H|about all the products you use (including prescription drugs,||
1326|033|H|nonprescription drugs, and herbal products).||
1326|034|H|   For the best effect, take this antifungal at evenly spaced||
1326|035|H|times. To help you remember, take this medication at the same||
1326|036|H|times every day.||
1326|037|H|   Continue to take this medication until the full prescribed||
1326|038|H|amount is finished, even if symptoms disappear after a few days.||
1326|039|H|Stopping the medication too early may result in a return of the||
1326|040|H|infection.||
1326|041|H|   Tell your doctor if your condition does not get better or if||
1326|042|H|it gets worse.||
1326|043|B|||
1326|044|S|SIDE EFFECTS:  Nausea/vomiting and headache may occur. If any of||
1326|045|S|these effects last or get worse, tell your doctor or pharmacist||
1326|046|S|promptly.||
1326|047|S|   Remember that this medication has been prescribed because your||
1326|048|S|doctor has judged that the benefit to you is greater than the||
1326|049|S|risk of side effects. Many people using this medication do not||
1326|050|S|have serious side effects.||
1326|051|S|   Tell your doctor right away if you have any serious side||
1326|052|S|effects, including: vision changes (such as blurred vision, color||
1326|053|S|vision changes), sensitivity of eyes to light (photophobia), eye||
1326|054|S|pain, signs of kidney problems (such as change in the amount of||
1326|055|S|urine), bone/joint pain, mental/mood changes (such as||
1326|056|S|hallucinations), swelling hands/ankles/feet, easy||
1326|057|S|bruising/bleeding, unusual skin changes, signs of your adrenal||
1326|058|S|glands not working well (such as loss of appetite, unusual||
1326|059|S|tiredness, weight loss).||
1326|060|S|   Get medical help right away if you have any very serious side||
1326|061|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1326|062|S|fainting.||
1326|063|S|   Voriconazole has rarely caused very serious (possibly fatal)||
1326|064|S|liver disease. Tell your doctor right away if you develop||
1326|065|S|symptoms of liver disease, such as: nausea/vomiting that doesn't||
1326|066|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
1326|067|S|eyes/skin, dark urine.||
1326|068|S|   Voriconazole can commonly cause a mild rash that is usually||
1326|069|S|not serious. However, you may not be able to tell it apart from a||
1326|070|S|rare rash that could be a sign of a severe allergic reaction. Get||
1326|071|S|medical help right away if you develop any rash.||
1326|072|S|   A very serious allergic reaction to this drug is rare.||
1326|073|S|However, get medical help right away if you notice any symptoms||
1326|074|S|of a serious allergic reaction, including: fever that doesn't go||
1326|075|S|away, new or worsening lymph node swelling, rash,||
1326|076|S|itching/swelling (especially of the face/tongue/throat), severe||
1326|077|S|dizziness, trouble breathing.||
1326|078|S|   This is not a complete list of possible side effects. If you||
1326|079|S|notice other effects not listed above, contact your doctor or||
1326|080|S|pharmacist.||
1326|081|S|   In the US -||
1326|082|S|   Call your doctor for medical advice about side effects. You||
1326|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1326|084|S|www.fda.gov/medwatch.||
1326|085|S|   In Canada - Call your doctor for medical advice about side||
1326|086|S|effects. You may report side effects to Health Canada at||
1326|087|S|1-866-234-2345.||
1326|088|B|||
1326|089|P|PRECAUTIONS:  Before taking voriconazole, tell your doctor or||
1326|090|P|pharmacist if you are allergic to it; or to other azole||
1326|091|P|antifungals (such as itraconazole); or if you have any other||
1326|092|P|allergies. This product may contain inactive ingredients, which||
1326|093|P|can cause allergic reactions or other problems. Talk to your||
1326|094|P|pharmacist for more details.||
1326|095|P|   Before using this medication, tell your doctor or pharmacist||
1326|096|P|your medical history, especially of: liver disease, heart||
1326|097|P|problems (such as irregular heartbeat).||
1326|098|P|   Voriconazole may cause a condition that affects the heart||
1326|099|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1326|100|P|serious (rarely fatal) fast/irregular heartbeat and other||
1326|101|P|symptoms (such as severe dizziness, fainting) that need medical||
1326|102|P|attention right away.||
1326|103|P|   The risk of QT prolongation may be increased if you have||
1326|104|P|certain medical conditions or are taking other drugs that may||
1326|105|P|cause QT prolongation. Before using voriconazole, tell your||
1326|106|P|doctor or pharmacist of all the drugs you take and if you have||
1326|107|P|any of the following conditions: certain heart problems (heart||
1326|108|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1326|109|P|history of certain heart problems (QT prolongation in the EKG,||
1326|110|P|sudden cardiac death).||
1326|111|P|   Low levels of potassium or magnesium in the blood may also||
1326|112|P|increase your risk of QT prolongation. This risk may increase if||
1326|113|P|you use certain drugs (such as diuretics/"water pills") or if you||
1326|114|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1326|115|P|Talk to your doctor about using voriconazole safely.||
1326|116|P|   This drug may cause vision changes. Do not drive, use||
1326|117|P|machinery, or do anything that needs clear vision until you can||
1326|118|P|do it safely. Do not drive at night.||
1326|119|P|   Avoid alcoholic beverages since they can increase the risk of||
1326|120|P|serious liver problems.||
1326|121|P|   This medication may make you more sensitive to the sun. It may||
1326|122|P|also increase your risk for skin cancer, especially if you take||
1326|123|P|it for a long time. Limit your time in the sun. Avoid tanning||
1326|124|P|booths and sunlamps. Use sunscreen and wear protective clothing||
1326|125|P|when outdoors. Tell your doctor right away if you get sunburned||
1326|126|P|or have skin blisters/redness, or notice new or changed||
1326|127|P|moles/skin lesions.||
1326|128|P|   Before having surgery, tell your doctor or dentist about all||
1326|129|P|the products you use (including prescription drugs,||
1326|130|P|nonprescription drugs, and herbal products).||
1326|131|P|   This product contains sucrose (sugar). Caution is advised if||
1326|132|P|you have diabetes or any other condition that requires you to||
1326|133|P|limit/avoid this substance in your diet. Ask your doctor or||
1326|134|P|pharmacist about using this product safely.||
1326|135|P|   Older adults may be more sensitive to the side effects of this||
1326|136|P|drug, especially QT prolongation (see above).||
1326|137|P|   Children may be at greater risk for liver problems and being||
1326|138|P|more sensitive to the sun while using this drug (see above).||
1326|139|P|   Tell your doctor if you are pregnant or plan to become||
1326|140|P|pregnant. You should not become pregnant while using||
1326|141|P|voriconazole. Voriconazole may harm an unborn baby. Ask about||
1326|142|P|reliable forms of birth control while using this medication. If||
1326|143|P|you become pregnant, talk to your doctor right away about the||
1326|144|P|risks and benefits of this medication.||
1326|145|P|   It is unknown if this medication passes into breast milk.||
1326|146|P|Because of the possible risk to the infant, breastfeeding is not||
1326|147|P|recommended while using this medication. Consult your doctor||
1326|148|P|before breastfeeding.||
1326|149|B|||
1326|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1326|151|I|medications work or increase your risk for serious side effects.||
1326|152|I|This document does not contain all possible drug interactions.||
1326|153|I|Keep a list of all the products you use (including||
1326|154|I|prescription/nonprescription drugs and herbal products) and share||
1326|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
1326|156|I|the dosage of any medicines without your doctor's approval.||
1326|157|I|   Voriconazole can slow down the removal of other medications||
1326|158|I|from your body, which may affect how they work. Examples of||
1326|159|I|affected drugs include eletriptan, ergot alkaloids (such as||
1326|160|I|dihydroergotamine, ergotamine), certain drugs to treat irregular||
1326|161|I|heartbeat (such disopyramide, dronedarone, quinidine),||
1326|162|I|ivabradine, lurasidone, naloxegol, pimozide, ranolazine,||
1326|163|I|sirolimus, certain "statin" cholesterol drugs (such as||
1326|164|I|lovastatin, simvastatin), tolvaptan, among others.||
1326|165|I|   Other medications can affect the removal of voriconazole from||
1326|166|I|your body, which may affect how voriconazole works. Examples||
1326|167|I|include butalbital, efavirenz, mitotane, rifamycins (such as||
1326|168|I|rifabutin, rifampin), ritonavir, secobarbital, certain drugs used||
1326|169|I|to treat seizures (such as carbamazepine, phenobarbital), St.||
1326|170|I|John's wort, among others.||
1326|171|I|   Many drugs besides voriconazole may affect the heart rhythm||
1326|172|I|(QT prolongation), including pacritinib, among others.||
1326|173|B|||
1326|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1326|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1326|176|O|poison control center right away. US residents can call||
1326|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1326|178|B|||
1326|179|N|NOTES:  Do not share this medication with others.||
1326|180|N|   This medication has been prescribed for your current condition||
1326|181|N|only. Do not use it later for another infection unless your||
1326|182|N|doctor tells you to.||
1326|183|N|   Lab and/or medical tests (such as liver/kidney function, blood||
1326|184|N|mineral levels) should be done before you start taking this||
1326|185|N|medication and while you are taking it. Keep all medical and lab||
1326|186|N|appointments. Consult your doctor for more details.||
1326|187|B|||
1326|188|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1326|189|D|remember. If it is near the time of the next dose, skip the||
1326|190|D|missed dose. Take your next dose at the regular time. Do not||
1326|191|D|double the dose to catch up.||
1326|192|B|||
1326|193|R|STORAGE:  Store at room temperature. Do not refrigerate or||
1326|194|R|freeze. Discard any unused portion after 14 days. Keep all||
1326|195|R|medications away from children and pets.||
1326|196|R|   Do not flush medications down the toilet or pour them into a||
1326|197|R|drain unless instructed to do so. Properly discard this product||
1326|198|R|when it is expired or no longer needed. Consult your pharmacist||
1326|199|R|or local waste disposal company.||
1326|200|B|||
1326|201|A|Information last revised April 2025.||
1326|202|A|Copyright(c) 2025 First Databank, Inc.||
1326|203|B|||
1328|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1328|002|Z|does NOT have all possible information about this product. This||
1328|003|Z|information does not assure that this product is safe, effective,||
1328|004|Z|or appropriate for you. This information is not individual||
1328|005|Z|medical advice and does not substitute for the advice of your||
1328|006|Z|health care professional. Always ask your health care||
1328|007|Z|professional for complete information about this product and your||
1328|008|Z|specific health needs.||
1328|009|B|||
1328|010|T|EZETIMIBE/ROSUVASTATIN - ORAL||
1328|011|F|(e-ZET-i-mibe/roe-SOO-ya-STAT-in)||
1328|012|B|||
1328|013|C|COMMON BRAND NAME(S): Roszet||
1328|014|B|||
1328|015|U|USES:  This combination medication is used along with a proper||
1328|016|U|diet to help lower "bad" cholesterol (such as LDL). Ezetimibe||
1328|017|U|works by reducing the amount of cholesterol your body absorbs||
1328|018|U|from your diet. Rosuvastatin belongs to a group of drugs known as||
1328|019|U|"statins." It works by reducing the amount of cholesterol made by||
1328|020|U|the liver.||
1328|021|U|   In addition to eating a proper diet (such as a||
1328|022|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
1328|023|U|help this medication work better include exercising, losing||
1328|024|U|weight if overweight, and stopping smoking. Consult your doctor||
1328|025|U|for more details.||
1328|026|U|   Lowering "bad" cholesterol and triglycerides and raising||
1328|027|U|"good" cholesterol decreases the risk of heart disease and helps||
1328|028|U|prevent strokes and heart attacks.||
1328|029|B|||
1328|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1328|031|H|from your pharmacist before you start taking this product and||
1328|032|H|each time you get a refill. If you have any questions, ask your||
1328|033|H|doctor or pharmacist.||
1328|034|H|   Take this medication by mouth with or without food as directed||
1328|035|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
1328|036|H|not crush, chew, or dissolve tablets.||
1328|037|H|   The dosage is based on your medical condition, response to||
1328|038|H|treatment, race, and other medications you may be taking. Be sure||
1328|039|H|to tell your doctor and pharmacist about all the products you use||
1328|040|H|(including prescription drugs, nonprescription drugs, and herbal||
1328|041|H|products). If you are of Asian descent, your doctor may direct||
1328|042|H|you to start with a lower dose because you may be more sensitive||
1328|043|H|to its effects.||
1328|044|H|   If you are taking a bile acid sequestrant (such as||
1328|045|H|cholestyramine or colestipol), take this product at least 2 hours||
1328|046|H|before or at least 4 hours after taking the bile acid||
1328|047|H|sequestrant. These medications may bind to||
1328|048|H|ezetimibe/rosuvastatin, preventing your body from fully absorbing||
1328|049|H|the drug.||
1328|050|H|   Antacids containing aluminum and magnesium can reduce the||
1328|051|H|absorption of this drug. If taking this type of antacid, take it||
1328|052|H|at least 2 hours after this medication.||
1328|053|H|   Take this medication regularly to get the most benefit from||
1328|054|H|it. To help you remember, take it at the same time each day. Keep||
1328|055|H|taking this medication even if you feel well. Most people with||
1328|056|H|high cholesterol do not feel sick.||
1328|057|H|   It is very important to continue to follow your doctor's||
1328|058|H|advice about diet and exercise. It may take up to 4 weeks before||
1328|059|H|you get the full benefit of this product.||
1328|060|B|||
1328|061|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1328|062|S|because your doctor has judged that the benefit to you is greater||
1328|063|S|than the risk of side effects. Many people using this medication||
1328|064|S|do not have serious side effects.||
1328|065|S|   A very small number of people taking rosuvastatin may have||
1328|066|S|mild memory problems or confusion. If these rare effects occur,||
1328|067|S|talk to your doctor.||
1328|068|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
1328|069|S|doctor about the benefits and risks.||
1328|070|S|   Tell your doctor right away if you have any serious side||
1328|071|S|effects, including: foamy urine.||
1328|072|S|   This drug may rarely cause muscle problems (which can rarely||
1328|073|S|lead to very serious conditions called rhabdomyolysis and||
1328|074|S|autoimmune myopathy). Tell your doctor right away if you develop||
1328|075|S|any of these symptoms during treatment and if these symptoms last||
1328|076|S|after your doctor stops this drug: muscle||
1328|077|S|pain/tenderness/weakness (especially with fever or unusual||
1328|078|S|tiredness), signs of kidney problems (such as change in the||
1328|079|S|amount of urine).||
1328|080|S|   This medication may rarely cause liver problems. Tell your||
1328|081|S|doctor right away if you develop symptoms of liver problems,||
1328|082|S|including: nausea/vomiting that doesn't stop, loss of appetite,||
1328|083|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
1328|084|S|   A very serious allergic reaction to this drug is rare.||
1328|085|S|However, get medical help right away if you notice any symptoms||
1328|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1328|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1328|088|S|breathing.||
1328|089|S|   This is not a complete list of possible side effects. If you||
1328|090|S|notice other effects not listed above, contact your doctor or||
1328|091|S|pharmacist.||
1328|092|S|   In the US -||
1328|093|S|   Call your doctor for medical advice about side effects. You||
1328|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1328|095|S|www.fda.gov/medwatch.||
1328|096|S|   In Canada - Call your doctor for medical advice about side||
1328|097|S|effects. You may report side effects to Health Canada at||
1328|098|S|1-866-234-2345.||
1328|099|B|||
1328|100|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1328|101|P|pharmacist if you are allergic to ezetimibe or rosuvastatin; or||
1328|102|P|if you have any other allergies. This product may contain||
1328|103|P|inactive ingredients, which can cause allergic reactions or other||
1328|104|P|problems. Talk to your pharmacist for more details.||
1328|105|P|   Before using this medication, tell your doctor or pharmacist||
1328|106|P|your medical history, especially of: liver disease, kidney||
1328|107|P|disease, alcohol use.||
1328|108|P|   Before having surgery, tell your doctor or dentist about all||
1328|109|P|the products you use (including prescription drugs,||
1328|110|P|nonprescription drugs, and herbal products).||
1328|111|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
1328|112|P|your risk for liver problems, especially when combined with this||
1328|113|P|product. Ask your doctor or pharmacist for more information.||
1328|114|P|   Older adults may be more sensitive to the side effects of this||
1328|115|P|drug, especially muscle problems.||
1328|116|P|   During pregnancy, this medication should be used only when||
1328|117|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1328|118|P|benefits with your doctor.||
1328|119|P|   This medication passes into breast milk. Because of the||
1328|120|P|possible risk to the infant, breastfeeding is not recommended||
1328|121|P|while using this medication. Consult your doctor before||
1328|122|P|breastfeeding.||
1328|123|B|||
1328|124|I|DRUG INTERACTIONS:  See also How to Use section.||
1328|125|I|   Drug interactions may change how your medications work or||
1328|126|I|increase your risk for serious side effects. This document does||
1328|127|I|not contain all possible drug interactions. Keep a list of all||
1328|128|I|the products you use (including prescription/nonprescription||
1328|129|I|drugs and herbal products) and share it with your doctor and||
1328|130|I|pharmacist. Do not start, stop, or change the dosage of any||
1328|131|I|medicines without your doctor's approval.||
1328|132|I|   Other medications can affect the removal of rosuvastatin from||
1328|133|I|your body, which may affect how rosuvastatin works. Examples||
1328|134|I|include cyclosporine, gemfibrozil, certain drugs to treat||
1328|135|I|hepatitis C (such as ledipasvir/sofosbuvir,||
1328|136|I|sofosbuvir/velpatasvir/voxilaprevir), among others.||
1328|137|I|   Do not take any red yeast rice products while you are taking||
1328|138|I|ezetimibe/rosuvastatin because some red yeast rice products may||
1328|139|I|also contain a statin called lovastatin. Taking||
1328|140|I|ezetimibe/rosuvastatin and red yeast rice products together can||
1328|141|I|increase your risk of serious muscle and liver problems.||
1328|142|B|||
1328|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1328|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1328|145|O|poison control center right away. US residents can call||
1328|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1328|147|B|||
1328|148|N|NOTES:  Do not share this medication with others.||
1328|149|N|   Lab and/or medical tests (such as blood||
1328|150|N|cholesterol/triglyceride levels, liver function) should be done||
1328|151|N|while you are taking this product. Keep all medical and lab||
1328|152|N|appointments. Consult your doctor for more details.||
1328|153|B|||
1328|154|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1328|155|D|next dose at the regular time. Do not double the dose to catch||
1328|156|D|up.||
1328|157|B|||
1328|158|R|STORAGE:  Store in the original bottle at room temperature away||
1328|159|R|from light and moisture. Do not store in the bathroom. Once the||
1328|160|R|bottle is opened, this medication expires after 30 days. Keep all||
1328|161|R|medications away from children and pets.||
1328|162|R|   Do not flush medications down the toilet or pour them into a||
1328|163|R|drain unless instructed to do so. Properly discard this product||
1328|164|R|when it is expired or no longer needed. Consult your pharmacist||
1328|165|R|or local waste disposal company.||
1328|166|B|||
1328|167|A|Information last revised July 2025.||
1328|168|A|Copyright(c) 2025 First Databank, Inc.||
1328|169|B|||
1329|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1329|002|Z|does NOT have all possible information about this product. This||
1329|003|Z|information does not assure that this product is safe, effective,||
1329|004|Z|or appropriate for you. This information is not individual||
1329|005|Z|medical advice and does not substitute for the advice of your||
1329|006|Z|health care professional. Always ask your health care||
1329|007|Z|professional for complete information about this product and your||
1329|008|Z|specific health needs.||
1329|009|B|||
1329|010|T|IDECABTAGENE VICLEUCEL - INJECTION||
1329|011|F|(EYE-de-KAB-ta-jeen vik-LOO-sel)||
1329|012|B|||
1329|013|C|COMMON BRAND NAME(S): Abecma||
1329|014|B|||
1329|015|W|WARNING:  This medication may cause serious (even fatal)||
1329|016|W|reactions (cytokine release syndrome-CRS, hemophagocytic||
1329|017|W|lymphohistiocytosis-HLH/macrophage activation syndrome-MAS).||
1329|018|W|Careful monitoring and prompt treatment may decrease your risk.||
1329|019|W|Before treatment with this medication, tell your doctor your||
1329|020|W|medical history, especially of any current/recent infection. Tell||
1329|021|W|your doctor right away if you have any symptoms such as high||
1329|022|W|fever, trouble breathing, chills/shaking chills, severe||
1329|023|W|nausea/vomiting/diarrhea, severe muscle/joint pain, very low||
1329|024|W|blood pressure, dizziness/lightheadedness, or signs of kidney||
1329|025|W|problems (such as change in the amount of urine).||
1329|026|W|   Serious nerve problems can occur after treatment with||
1329|027|W|idecabtagene vicleucel. Tell your doctor right away if you have||
1329|028|W|drowsiness, seizure(s), mental/mood changes (such as confusion,||
1329|029|W|anxiety, memory loss), or trouble with reading, writing,||
1329|030|W|speaking, or understanding.||
1329|031|W|   This product may cause a severe decrease in your blood cells,||
1329|032|W|which lowers your ability to fight infections and increases the||
1329|033|W|risk of anemia/bleeding problems. You may be more likely to get a||
1329|034|W|serious (rarely fatal) infection and any infection you have may||
1329|035|W|get worse. Tell your doctor right away if you have signs of||
1329|036|W|infection (such as sore throat that doesn't go away, fever,||
1329|037|W|chills, cough), easy or unusual bruising/bleeding, or unusual||
1329|038|W|tiredness.||
1329|039|B|||
1329|040|U|USES:  Idecabtagene vicleucel is used to treat a certain type of||
1329|041|U|cancer (multiple myeloma) that has not gotten better or that has||
1329|042|U|come back after other kinds of treatment. This type of treatment||
1329|043|U|is known as gene therapy. Idecabtagene vicleucel is made from||
1329|044|U|your own white blood cells and is given only to you. The white||
1329|045|U|blood cells have been changed to have a specific protein||
1329|046|U|(chimeric antigen receptor-CAR) that helps your body slow or stop||
1329|047|U|the growth of certain cancer cells.||
1329|048|B|||
1329|049|H|HOW TO USE:  Read the Medication Guide provided by your health||
1329|050|H|care professional before you start using this product. If you||
1329|051|H|have any questions, ask your health care professionals.||
1329|052|H|   Your doctor will give you 3 days of chemotherapy before||
1329|053|H|treatment with this product to prepare your body.||
1329|054|H|   This product is given by slow injection into a vein as||
1329|055|H|directed by your doctor. You will receive one or more injections,||
1329|056|H|one right after another. Each injection is given over about 30||
1329|057|H|minutes. To decrease the risk of side effects, your doctor may||
1329|058|H|also give you other medications (such as acetaminophen,||
1329|059|H|diphenhydramine) before injecting idecabtagene vicleucel.||
1329|060|H|   Your doctor will check you daily for at least 7 days after||
1329|061|H|your treatment to see how well it works and help you manage any||
1329|062|H|side effects. You should plan to stay for at least 2 weeks near||
1329|063|H|the place of your treatment (for example, within 2 hours' drive).||
1329|064|B|||
1329|065|S|SIDE EFFECTS:  See also Warning section.||
1329|066|S|   Nausea, constipation, headache, tiredness, trouble sleeping,||
1329|067|S|or loss of appetite may occur. If any of these effects last or||
1329|068|S|get worse, tell your doctor or pharmacist promptly.||
1329|069|S|   People using this medication may have serious side effects.||
1329|070|S|However, you have been prescribed this drug because your doctor||
1329|071|S|has judged that the benefit to you is greater than the risk of||
1329|072|S|side effects. Careful monitoring by your doctor may decrease your||
1329|073|S|risk.||
1329|074|S|   Tell your doctor right away if you have any serious side||
1329|075|S|effects, including: fast/irregular heartbeat, muscle/joint pain,||
1329|076|S|swelling.||
1329|077|S|   Although idecabtagene vicleucel is used to treat cancer, it||
1329|078|S|may rarely increase your risk of developing other cancers. Tell||
1329|079|S|your doctor right away if you develop swollen lymph nodes or||
1329|080|S|unusual growths/lumps.||
1329|081|S|   A very serious allergic reaction to this drug is rare.||
1329|082|S|However, get medical help right away if you notice any symptoms||
1329|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1329|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1329|085|S|breathing.||
1329|086|S|   This is not a complete list of possible side effects. If you||
1329|087|S|notice other effects not listed above, contact your doctor or||
1329|088|S|pharmacist.||
1329|089|S|   In the US -||
1329|090|S|   Call your doctor for medical advice about side effects. You||
1329|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1329|092|S|www.fda.gov/medwatch.||
1329|093|S|   In Canada - Call your doctor for medical advice about side||
1329|094|S|effects. You may report side effects to Health Canada at||
1329|095|S|1-866-234-2345.||
1329|096|B|||
1329|097|P|PRECAUTIONS:  Before receiving idecabtagene vicleucel, tell your||
1329|098|P|doctor or pharmacist if you have any allergies. This product may||
1329|099|P|contain inactive ingredients, which can cause allergic reactions||
1329|100|P|or other problems. Talk to your pharmacist for more details.||
1329|101|P|   Before using this medication, tell your doctor or pharmacist||
1329|102|P|your medical history, especially of: heart problems, kidney/liver||
1329|103|P|problems, lung or breathing problems, nerve problems (such as||
1329|104|P|memory loss, seizures), past/current/recent infection.||
1329|105|P|   This product can make you more likely to get infections or may||
1329|106|P|make current infections worse. Stay away from anyone who has an||
1329|107|P|infection that may easily spread (such as chickenpox, COVID-19,||
1329|108|P|measles, flu). Talk to your doctor if you have been exposed to an||
1329|109|P|infection or for more details.||
1329|110|P|   Tell your health care professional that you are using||
1329|111|P|idecabtagene vicleucel before having any||
1329|112|P|immunizations/vaccinations. Avoid contact with people who have||
1329|113|P|recently received live vaccines (such as flu vaccine inhaled||
1329|114|P|through the nose).||
1329|115|P|   To lower the chance of getting cut, bruised, or injured, use||
1329|116|P|caution with sharp objects like razors and nail cutters, and||
1329|117|P|avoid activities such as contact sports.||
1329|118|P|   This drug may make you drowsy or dizzy, affect your||
1329|119|P|coordination, or make it harder for you to think clearly. Alcohol||
1329|120|P|or marijuana (cannabis) can worsen these effects. Do not drive,||
1329|121|P|use machinery, or do anything that needs alertness until you can||
1329|122|P|do it safely (at least 2 weeks after receiving treatment is||
1329|123|P|recommended by the manufacturer). Limit alcoholic beverages. Talk||
1329|124|P|to your doctor if you are using marijuana (cannabis).||
1329|125|P|   Before having surgery, tell your doctor or dentist about all||
1329|126|P|the products you use (including prescription drugs,||
1329|127|P|nonprescription drugs, and herbal products).||
1329|128|P|   Tell your doctor if you are pregnant or plan to become||
1329|129|P|pregnant. You should not become pregnant while using this||
1329|130|P|product. Idecabtagene vicleucel may harm an unborn baby. Your||
1329|131|P|doctor should order a pregnancy test before you start this||
1329|132|P|product. If you become pregnant, talk to your doctor right away||
1329|133|P|about the risks and benefits of this product.||
1329|134|P|   It is unknown if this product passes into breast milk. Consult||
1329|135|P|your doctor before breastfeeding.||
1329|136|B|||
1329|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1329|138|I|medications work or increase your risk for serious side effects.||
1329|139|I|This document does not contain all possible drug interactions.||
1329|140|I|Keep a list of all the products you use (including||
1329|141|I|prescription/nonprescription drugs and herbal products) and share||
1329|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
1329|143|I|the dosage of any medicines without your doctor's approval.||
1329|144|I|   This medication may interfere with certain lab tests (such as||
1329|145|I|some HIV tests), possibly causing false test results. Make sure||
1329|146|I|lab personnel and all your doctors know you use this drug.||
1329|147|B|||
1329|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1329|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1329|150|O|poison control center right away. US residents can call||
1329|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1329|152|B|||
1329|153|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
1329|154|N|should be done before and after you receive this product. Keep||
1329|155|N|all medical and lab appointments.||
1329|156|N|   After receiving this treatment, do not donate blood, organs,||
1329|157|N|tissues, or cells.||
1329|158|B|||
1329|159|D|MISSED DOSE:  Not applicable.||
1329|160|B|||
1329|161|R|STORAGE:  Not applicable. This product is given in a hospital or||
1329|162|R|clinic and will not be stored at home.||
1329|163|B|||
1329|164|M|MEDICAL ALERT:  Your condition can cause complications in a||
1329|165|M|medical emergency. For information about enrolling in MedicAlert,||
1329|166|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1329|167|B|||
1329|168|A|Information last revised June 2025.||
1329|169|A|Copyright(c) 2025 First Databank, Inc.||
1329|170|B|||
1330|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1330|002|Z|does NOT have all possible information about this product. This||
1330|003|Z|information does not assure that this product is safe, effective,||
1330|004|Z|or appropriate for you. This information is not individual||
1330|005|Z|medical advice and does not substitute for the advice of your||
1330|006|Z|health care professional. Always ask your health care||
1330|007|Z|professional for complete information about this product and your||
1330|008|Z|specific health needs.||
1330|009|B|||
1330|010|T|VILOXAZINE EXTENDED-RELEASE - ORAL||
1330|011|F|(vye-LOX-a-zeen)||
1330|012|B|||
1330|013|C|COMMON BRAND NAME(S): Qelbree||
1330|014|B|||
1330|015|W|WARNING:  A small number of people who take viloxazine for||
1330|016|W|attention-deficit hyperactivity disorder (ADHD) may experience||
1330|017|W|worsening of their condition, other mental/mood symptoms, or||
1330|018|W|suicidal thoughts/attempts. It is very important to talk with the||
1330|019|W|doctor about the risks and benefits of this medication.||
1330|020|W|   Tell the doctor right away if you notice worsening of your||
1330|021|W|condition/other psychiatric conditions, unusual behavior changes||
1330|022|W|(including possible suicidal thoughts/attempts), or other||
1330|023|W|mental/mood changes (including new/worsening anxiety, panic||
1330|024|W|attacks, depression, trouble sleeping, irritability,||
1330|025|W|hostile/angry feelings, hallucinations, delusions, impulsive||
1330|026|W|actions, severe restlessness, very rapid speech). Be especially||
1330|027|W|watchful for these symptoms when you first start this medication||
1330|028|W|or when the dose is changed.||
1330|029|B|||
1330|030|U|USES:  Viloxazine is used to treat attention-deficit||
1330|031|U|hyperactivity disorder (ADHD) as part of a total treatment plan,||
1330|032|U|including psychological, social, and other treatments. It may||
1330|033|U|help to increase the ability to pay attention, concentrate, stay||
1330|034|U|focused, and stop fidgeting. It is thought to work by restoring||
1330|035|U|the balance of certain natural substances (neurotransmitters) in||
1330|036|U|the brain.||
1330|037|B|||
1330|038|H|HOW TO USE:  Read the Medication Guide provided by your||
1330|039|H|pharmacist before you start using viloxazine and each time you||
1330|040|H|get a refill. If you have any questions, ask your doctor or||
1330|041|H|pharmacist.||
1330|042|H|   Take this medication with or without food as directed by your||
1330|043|H|doctor, usually once daily. Swallow the capsules whole. Do not||
1330|044|H|crush, chew, or cut the capsules. Doing so can release all of the||
1330|045|H|drug at once, increasing the risk of side effects.||
1330|046|H|   If you have trouble swallowing the capsules whole, you may||
1330|047|H|open the capsule and sprinkle the contents onto a spoonful of||
1330|048|H|pudding or applesauce. Swallow all of the mixture without||
1330|049|H|chewing. The mixture should be used within 15 minutes if mixing||
1330|050|H|with pudding or within 2 hours if mixing with applesauce. Do not||
1330|051|H|save the mixture for future use.||
1330|052|H|   The dosage is based on your age, medical condition, and||
1330|053|H|response to treatment.||
1330|054|H|   Use this medication regularly to get the most benefit from it.||
1330|055|H|To help you remember, take it at the same time each day.||
1330|056|H|   Do not increase your dose or use this drug more often or for||
1330|057|H|longer than prescribed. Your condition will not improve any||
1330|058|H|faster, and your risk of side effects will increase.||
1330|059|H|   Tell your doctor if your condition does not get better or if||
1330|060|H|it gets worse.||
1330|061|B|||
1330|062|S|SIDE EFFECTS:  See also Warning section.||
1330|063|S|   Drowsiness, tiredness, headache, decreased appetite, nausea,||
1330|064|S|vomiting, dry mouth, or constipation may occur. If any of these||
1330|065|S|effects last or get worse, tell your doctor or pharmacist||
1330|066|S|promptly.||
1330|067|S|   Remember that this medication has been prescribed because your||
1330|068|S|doctor has judged that the benefit to you is greater than the||
1330|069|S|risk of side effects. Many people using this medication do not||
1330|070|S|have serious side effects.||
1330|071|S|   This medication may raise your blood pressure. Check your||
1330|072|S|blood pressure regularly and tell your doctor if the results are||
1330|073|S|high.||
1330|074|S|   Tell your doctor right away if you have any serious side||
1330|075|S|effects, including: easy bleeding/bruising, fast heartbeat,||
1330|076|S|unusual weight loss.||
1330|077|S|   Get medical help right away if you have any very serious side||
1330|078|S|effects, including: black stools, vomit that looks like coffee||
1330|079|S|grounds.||
1330|080|S|   A very serious allergic reaction to this drug is rare.||
1330|081|S|However, get medical help right away if you notice any symptoms||
1330|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1330|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1330|084|S|breathing.||
1330|085|S|   This is not a complete list of possible side effects. If you||
1330|086|S|notice other effects not listed above, contact your doctor or||
1330|087|S|pharmacist.||
1330|088|S|   In the US -||
1330|089|S|   Call your doctor for medical advice about side effects. You||
1330|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1330|091|S|www.fda.gov/medwatch.||
1330|092|S|   In Canada - Call your doctor for medical advice about side||
1330|093|S|effects. You may report side effects to Health Canada at||
1330|094|S|1-866-234-2345.||
1330|095|B|||
1330|096|P|PRECAUTIONS:  Before taking viloxazine, tell your doctor or||
1330|097|P|pharmacist if you are allergic to it; or if you have any other||
1330|098|P|allergies. This product may contain inactive ingredients, which||
1330|099|P|can cause allergic reactions or other problems. Talk to your||
1330|100|P|pharmacist for more details.||
1330|101|P|   Before using this medication, tell your doctor or pharmacist||
1330|102|P|your medical history, especially of: bleeding problems, high||
1330|103|P|blood pressure, fast heartbeat, kidney disease, liver disease,||
1330|104|P|personal/family history of mental/mood disorders (such as bipolar||
1330|105|P|disorder, depression, suicidal thoughts).||
1330|106|P|   This drug may make you drowsy or tired. Alcohol or marijuana||
1330|107|P|(cannabis) can make you more drowsy or tired. Do not drive, use||
1330|108|P|machinery, or do anything that needs alertness until you can do||
1330|109|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1330|110|P|are using marijuana (cannabis).||
1330|111|P|   Before having surgery, tell your doctor or dentist about all||
1330|112|P|the products you use (including prescription drugs,||
1330|113|P|nonprescription drugs, and herbal products).||
1330|114|P|   Older adults may be more sensitive to the side effects of this||
1330|115|P|drug, especially bleeding.||
1330|116|P|   During pregnancy, this medication should be used only when||
1330|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
1330|118|P|   This medication passes into breast milk. Consult your doctor||
1330|119|P|before breastfeeding.||
1330|120|B|||
1330|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1330|122|I|medications work or increase your risk for serious side effects.||
1330|123|I|This document does not contain all possible drug interactions.||
1330|124|I|Keep a list of all the products you use (including||
1330|125|I|prescription/nonprescription drugs and herbal products) and share||
1330|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
1330|127|I|the dosage of any medicines without your doctor's approval.||
1330|128|I|   Some products that may interact with this drug are: other||
1330|129|I|drugs that can cause bleeding/bruising (including antiplatelet||
1330|130|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
1330|131|I|"blood thinners" such as dabigatran/warfarin).||
1330|132|I|   Taking MAO inhibitors with this medication may cause a serious||
1330|133|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1330|134|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1330|135|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1330|136|I|selegiline, tranylcypromine) during treatment with this||
1330|137|I|medication. Most MAO inhibitors should also not be taken for two||
1330|138|I|weeks before and after treatment with this medication. Ask your||
1330|139|I|doctor when to start or stop taking this medication.||
1330|140|I|   This medication can slow down the removal of other medications||
1330|141|I|from your body, which may affect how they work. Examples of||
1330|142|I|affected drugs include alosetron, duloxetine, fezolinetant,||
1330|143|I|ramelteon, tasimelteon, tizanidine, theophylline, among others.||
1330|144|I|   Aspirin can increase the risk of bleeding when used with this||
1330|145|I|medication. However, if your doctor has told you to take low-dose||
1330|146|I|aspirin to prevent heart attack or stroke (usually 81-162||
1330|147|I|milligrams a day), you should keep taking the aspirin unless your||
1330|148|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1330|149|I|details.||
1330|150|I|   Some products have ingredients that could raise your heart||
1330|151|I|rate or blood pressure. Tell your pharmacist what products you||
1330|152|I|are using, and ask how to use them safely (especially||
1330|153|I|cough-and-cold products, diet aids, or NSAIDs such as||
1330|154|I|ibuprofen/naproxen).||
1330|155|B|||
1330|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1330|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1330|158|O|poison control center right away. US residents can call||
1330|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1330|160|O|Symptoms of overdose may include: severe drowsiness.||
1330|161|B|||
1330|162|N|NOTES:  Do not share this medication with others.||
1330|163|N|   Lab and/or medical tests (such as pulse, blood pressure,||
1330|164|N|weight) should be done while you are taking this medication. Keep||
1330|165|N|all medical and lab appointments. Consult your doctor for more||
1330|166|N|details.||
1330|167|B|||
1330|168|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1330|169|D|remember. If it is near the time of the next dose, skip the||
1330|170|D|missed dose. Take your next dose at the regular time. Do not||
1330|171|D|double the dose to catch up.||
1330|172|B|||
1330|173|R|STORAGE:  Store at room temperature away from light and moisture.||
1330|174|R|Do not store in the bathroom. Keep all medications away from||
1330|175|R|children and pets.||
1330|176|R|   Do not flush medications down the toilet or pour them into a||
1330|177|R|drain unless instructed to do so. Properly discard this product||
1330|178|R|when it is expired or no longer needed. Consult your pharmacist||
1330|179|R|or local waste disposal company.||
1330|180|B|||
1330|181|A|Information last revised February 2025.||
1330|182|A|Copyright(c) 2025 First Databank, Inc.||
1330|183|B|||
1331|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1331|002|Z|does NOT have all possible information about this product. This||
1331|003|Z|information does not assure that this product is safe, effective,||
1331|004|Z|or appropriate for you. This information is not individual||
1331|005|Z|medical advice and does not substitute for the advice of your||
1331|006|Z|health care professional. Always ask your health care||
1331|007|Z|professional for complete information about this product and your||
1331|008|Z|specific health needs.||
1331|009|B|||
1331|010|T|TRANEXAMIC ACID 650 MILLIGRAM TABLET - ORAL||
1331|011|F|(TRAN-ex-AM-ik AS-id)||
1331|012|B|||
1331|013|C|COMMON BRAND NAME(S): Lysteda||
1331|014|B|||
1331|015|U|USES:  This medication is used to treat heavy bleeding during||
1331|016|U|your menstrual period. Tranexamic acid works by slowing the||
1331|017|U|breakdown of blood clots, which helps to prevent prolonged||
1331|018|U|bleeding. It belongs to a class of drugs known as||
1331|019|U|antifibrinolytics.||
1331|020|U|   Tranexamic acid is not a hormone. It does not treat other||
1331|021|U|menstrual or pre-menstrual symptoms. It does not stop your||
1331|022|U|period.||
1331|023|B|||
1331|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1331|025|H|from your pharmacist before you start taking tranexamic acid and||
1331|026|H|each time you get a refill. If you have any questions, ask your||
1331|027|H|doctor or pharmacist.||
1331|028|H|   Take this medication by mouth with or without food as directed||
1331|029|H|by your doctor, usually 3 times a day. Swallow this medication||
1331|030|H|whole. Do not crush or chew. Wait until your period has started||
1331|031|H|before taking your first dose. Do not take tranexamic acid for||
1331|032|H|more than 5 days in a row.||
1331|033|H|   The dosage is based on your medical condition and response to||
1331|034|H|treatment.||
1331|035|H|   Tell your doctor if there is a change in your bleeding pattern||
1331|036|H|or heavy bleeding lasts or gets worse.||
1331|037|B|||
1331|038|S|SIDE EFFECTS:  See also How to use section.||
1331|039|S|   Nausea, vomiting, diarrhea, and muscle pain may occur. If any||
1331|040|S|of these effects last or get worse, tell your doctor or||
1331|041|S|pharmacist promptly.||
1331|042|S|   Remember that this medication has been prescribed because your||
1331|043|S|doctor has judged that the benefit to you is greater than the||
1331|044|S|risk of side effects. Many people using this medication do not||
1331|045|S|have serious side effects.||
1331|046|S|   Tell your doctor right away if you have any serious side||
1331|047|S|effects, including: eye/eyelid problems.||
1331|048|S|   This medication may rarely cause serious problems from blood||
1331|049|S|clots. Stop taking tranexamic acid and get medical help right||
1331|050|S|away if any of these side effects occur: sudden||
1331|051|S|dizziness/fainting, chest/jaw/left arm pain, pain/swelling/warmth||
1331|052|S|in the groin/calf, weakness on one side of the body, trouble||
1331|053|S|speaking, sudden/severe headaches, confusion, sudden vision||
1331|054|S|changes, unusual sweating, shortness of breath/rapid breathing.||
1331|055|S|   A very serious allergic reaction to this drug is rare.||
1331|056|S|However, get medical help right away if you notice any symptoms||
1331|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1331|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1331|059|S|breathing.||
1331|060|S|   This is not a complete list of possible side effects. If you||
1331|061|S|notice other effects not listed above, contact your doctor or||
1331|062|S|pharmacist.||
1331|063|S|   In the US -||
1331|064|S|   Call your doctor for medical advice about side effects. You||
1331|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1331|066|S|www.fda.gov/medwatch.||
1331|067|S|   In Canada - Call your doctor for medical advice about side||
1331|068|S|effects. You may report side effects to Health Canada at||
1331|069|S|1-866-234-2345.||
1331|070|B|||
1331|071|P|PRECAUTIONS:  Before taking tranexamic acid, tell your doctor or||
1331|072|P|pharmacist if you are allergic to it; or if you have any other||
1331|073|P|allergies. This product may contain inactive ingredients, which||
1331|074|P|can cause allergic reactions or other problems. Talk to your||
1331|075|P|pharmacist for more details.||
1331|076|P|   Before using this medication, tell your doctor or pharmacist||
1331|077|P|your medical history, especially of: bleeding in the brain||
1331|078|P|(subarachnoid hemorrhage), history of blood clots (such as in the||
1331|079|P|legs, lung, brain, eye), certain heart diseases (irregular||
1331|080|P|heartbeat, heart valve problems), blood clotting problems, kidney||
1331|081|P|problems (including blood in the urine), irregular menstrual||
1331|082|P|bleeding of unknown cause.||
1331|083|P|   Before having surgery, tell your doctor or dentist about all||
1331|084|P|the products you use (including prescription drugs,||
1331|085|P|nonprescription drugs, and herbal products).||
1331|086|P|   This medication is usually used during your menstrual period.||
1331|087|P|It is unlikely to be used during pregnancy. During pregnancy,||
1331|088|P|this medication should be used only when clearly needed. Discuss||
1331|089|P|the risks and benefits with your doctor.||
1331|090|P|   This drug passes into breast milk. Consult your doctor before||
1331|091|P|breastfeeding.||
1331|092|B|||
1331|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1331|094|I|medications work or increase your risk for serious side effects.||
1331|095|I|This document does not contain all possible drug interactions.||
1331|096|I|Keep a list of all the products you use (including||
1331|097|I|prescription/nonprescription drugs and herbal products) and share||
1331|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
1331|099|I|the dosage of any medicines without your doctor's approval.||
1331|100|I|   Some products that may interact with this drug include: "blood||
1331|101|I|thinners" (anticoagulants such as warfarin, heparin), drugs that||
1331|102|I|prevent bleeding (including factor IX complex, anti-inhibitor||
1331|103|I|coagulant concentrates), estrogens, hormonal birth control (such||
1331|104|I|as pills, patch, ring), tibolone, tretinoin.||
1331|105|I|   Check all prescription and nonprescription medicine labels||
1331|106|I|carefully since many medications contain pain relievers/fever||
1331|107|I|reducers (NSAIDs such as aspirin, ibuprofen, naproxen) that may||
1331|108|I|increase your risk of bleeding. However, if your doctor has told||
1331|109|I|you to take low-dose aspirin to prevent heart attack or stroke||
1331|110|I|(usually 81-162 milligrams a day), you should keep taking the||
1331|111|I|aspirin unless your doctor tells you not to. Ask your doctor or||
1331|112|I|pharmacist for more details.||
1331|113|B|||
1331|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1331|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1331|116|O|poison control center right away. US residents can call||
1331|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1331|118|O|Symptoms of overdose may include: severe dizziness, vomiting.||
1331|119|B|||
1331|120|N|NOTES:  Do not share this medication with others.||
1331|121|N|   Lab and/or medical tests (such as kidney function, eye||
1331|122|N|examinations) should be done while you are taking this||
1331|123|N|medication. Keep all medical and lab appointments. Consult your||
1331|124|N|doctor for more details.||
1331|125|B|||
1331|126|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1331|127|D|remember. If it is near the time of the next dose, skip the||
1331|128|D|missed dose. Take your next dose at the regular time. Do not||
1331|129|D|double the dose to catch up.||
1331|130|B|||
1331|131|R|STORAGE:  Store at room temperature away from light and moisture.||
1331|132|R|Do not store in the bathroom. Keep all medications away from||
1331|133|R|children and pets.||
1331|134|R|   Do not flush medications down the toilet or pour them into a||
1331|135|R|drain unless instructed to do so. Properly discard this product||
1331|136|R|when it is expired or no longer needed. Consult your pharmacist||
1331|137|R|or local waste disposal company.||
1331|138|B|||
1331|139|A|Information last revised October 2025.||
1331|140|A|Copyright(c) 2025 First Databank, Inc.||
1331|141|B|||
1332|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1332|002|Z|does NOT have all possible information about this product. This||
1332|003|Z|information does not assure that this product is safe, effective,||
1332|004|Z|or appropriate for you. This information is not individual||
1332|005|Z|medical advice and does not substitute for the advice of your||
1332|006|Z|health care professional. Always ask your health care||
1332|007|Z|professional for complete information about this product and your||
1332|008|Z|specific health needs.||
1332|009|B|||
1332|010|T|DICLOFENAC POWDER PACKETS - ORAL||
1332|011|F|(dye-KLOE-fen-ak)||
1332|012|B|||
1332|013|C|COMMON BRAND NAME(S): Cambia||
1332|014|B|||
1332|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1332|016|W|diclofenac) may rarely increase the risk of a heart attack or||
1332|017|W|stroke. This effect can happen at any time while taking this drug||
1332|018|W|but is more likely if you take it for a long time. The risk may||
1332|019|W|be greater in older adults or if you have heart disease or||
1332|020|W|increased risk for heart disease (for example, due to smoking,||
1332|021|W|family history of heart disease, or conditions such as high blood||
1332|022|W|pressure or diabetes). Do not take this drug right before or||
1332|023|W|after heart bypass surgery (CABG).||
1332|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
1332|025|W|bleeding from the stomach or intestines. This effect can occur||
1332|026|W|without warning symptoms at any time while taking this drug.||
1332|027|W|Older adults may be at higher risk for this effect.||
1332|028|W|   Stop taking diclofenac and get medical help right away if you||
1332|029|W|notice any of these rare but serious side effects:||
1332|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
1332|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1332|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
1332|033|W|side of the body, trouble speaking, sudden vision changes.||
1332|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
1332|035|W|of taking this drug.||
1332|036|B|||
1332|037|U|USES:  See also Warning section.||
1332|038|U|   This powder form of diclofenac is used to treat migraine||
1332|039|U|headaches. Diclofenac is not used to prevent migraines from||
1332|040|U|happening or lessen how often you get them.||
1332|041|U|   Diclofenac is known as a nonsteroidal anti-inflammatory drug||
1332|042|U|(NSAID). It works by blocking your body's production of certain||
1332|043|U|natural substances that cause inflammation. This effect helps to||
1332|044|U|decrease swelling, pain, or fever.||
1332|045|B|||
1332|046|V|OTHER USES:  This section contains uses of this drug that are not||
1332|047|V|listed in the approved professional labeling for the drug but||
1332|048|V|that may be prescribed by your health care professional. Use this||
1332|049|V|drug for a condition that is listed in this section only if it||
1332|050|V|has been so prescribed by your health care professional.||
1332|051|V|   This medication may also be used for other painful conditions||
1332|052|V|such as menstrual cramp, arthritis, kidney pain, bursitis, and||
1332|053|V|tendonitis.||
1332|054|B|||
1332|055|H|HOW TO USE:  Read the Medication Guide provided by your||
1332|056|H|pharmacist before you start taking diclofenac and each time you||
1332|057|H|get a refill. If you have any questions, ask your doctor or||
1332|058|H|pharmacist.||
1332|059|H|   Take this medication by mouth as directed by your doctor. If||
1332|060|H|you do not get better, do not take more doses of this medication||
1332|061|H|before talking to your doctor. According to the manufacturer, you||
1332|062|H|should not take more than 1 packet per migraine attack.||
1332|063|H|   Empty the contents of one packet into a cup containing 1 to 2||
1332|064|H|ounces (30 to 60 milliliters) of water. Mix well and drink all of||
1332|065|H|it right away. Do not mix with any liquid other than water. If||
1332|066|H|stomach upset occurs while taking this medication, take it with||
1332|067|H|food, milk, or an antacid. However, if you take this medication||
1332|068|H|with a meal high in fat, it may not work as well.||
1332|069|H|   There are different brands and forms of this medication||
1332|070|H|available. Because different forms do not have the same effects||
1332|071|H|at equal strengths, do not switch forms of diclofenac unless your||
1332|072|H|doctor tells you to.||
1332|073|H|   To reduce your risk of stomach bleeding and other side||
1332|074|H|effects, take this medication at the lowest effective dose. Do||
1332|075|H|not increase your dose or take it more often than prescribed.||
1332|076|H|   Pain medications work best if they are used as the first signs||
1332|077|H|of pain or migraine occur. If you wait until the pain has||
1332|078|H|worsened, the medication may not work as well.||
1332|079|H|   If you are using drugs for migraine attacks on 10 or more days||
1332|080|H|each month, the drugs may actually make your headaches worse||
1332|081|H|(medication overuse headache). Do not use medications more often||
1332|082|H|or for longer than directed. Tell your doctor if you need to use||
1332|083|H|this medication more often, or if the medication is not working||
1332|084|H|as well, or if your headaches get worse.||
1332|085|B|||
1332|086|S|SIDE EFFECTS:  See also Warning section.||
1332|087|S|   Upset stomach, nausea, vomiting, heartburn, diarrhea,||
1332|088|S|constipation, gas, headache, drowsiness, dizziness, or blurred||
1332|089|S|vision may occur. If any of these effects last or get worse, tell||
1332|090|S|your doctor or pharmacist promptly.||
1332|091|S|   Remember that this medication has been prescribed because your||
1332|092|S|doctor has judged that the benefit to you is greater than the||
1332|093|S|risk of side effects. Many people using this medication do not||
1332|094|S|have serious side effects.||
1332|095|S|   This medication may raise your blood pressure. Check your||
1332|096|S|blood pressure regularly and tell your doctor if the results are||
1332|097|S|high.||
1332|098|S|   Tell your doctor right away if you have any serious side||
1332|099|S|effects, including: hearing changes (such as ringing in the||
1332|100|S|ears), mental/mood changes, easy bleeding/bruising,||
1332|101|S|difficult/painful swallowing, signs of kidney problems (such as||
1332|102|S|change in the amount of urine, pink/bloody urine), symptoms of||
1332|103|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
1332|104|S|unusual/sudden weight gain).||
1332|105|S|   Diclofenac may rarely cause serious (possibly fatal) liver||
1332|106|S|disease. Get medical help right away if you have any symptoms of||
1332|107|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
1332|108|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1332|109|S|urine.||
1332|110|S|   A very serious allergic reaction to this drug is rare.||
1332|111|S|However, get medical help right away if you notice any symptoms||
1332|112|S|of a serious allergic reaction, including: fever, swollen lymph||
1332|113|S|nodes, rash, itching/swelling (especially of the||
1332|114|S|face/tongue/throat), severe dizziness, trouble breathing.||
1332|115|S|   This is not a complete list of possible side effects. If you||
1332|116|S|notice other effects not listed above, contact your doctor or||
1332|117|S|pharmacist.||
1332|118|S|   In the US -||
1332|119|S|   Call your doctor for medical advice about side effects. You||
1332|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1332|121|S|www.fda.gov/medwatch.||
1332|122|S|   In Canada - Call your doctor for medical advice about side||
1332|123|S|effects. You may report side effects to Health Canada at||
1332|124|S|1-866-234-2345.||
1332|125|B|||
1332|126|P|PRECAUTIONS:  See also Warning section.||
1332|127|P|   Before taking diclofenac, tell your doctor or pharmacist if||
1332|128|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
1332|129|P|ibuprofen, naproxen, celecoxib); or if you have any other||
1332|130|P|allergies. This product may contain inactive ingredients, which||
1332|131|P|can cause allergic reactions or other problems. Talk to your||
1332|132|P|pharmacist for more details.||
1332|133|P|   Before taking this medication, tell your doctor or pharmacist||
1332|134|P|your medical history, especially of: asthma (including a history||
1332|135|P|of worsening breathing after taking aspirin or other NSAIDs),||
1332|136|P|blood disorders (such as anemia, bleeding/clotting problems),||
1332|137|P|growths in the nose (nasal polyps), heart disease (such as||
1332|138|P|previous heart attack), high blood pressure, liver disease,||
1332|139|P|stroke, swelling (edema, fluid retention),||
1332|140|P|stomach/intestinal/esophagus problems (such as bleeding,||
1332|141|P|heartburn, ulcers).||
1332|142|P|   Kidney problems can sometimes occur with the use of NSAID||
1332|143|P|medications, including diclofenac. Problems are more likely to||
1332|144|P|occur if you are dehydrated, have heart failure or kidney||
1332|145|P|disease, are an older adult, or if you take certain medications||
1332|146|P|(see also Drug Interactions section). Drink plenty of fluids as||
1332|147|P|directed by your doctor to prevent dehydration and tell your||
1332|148|P|doctor right away if you have pink/bloody urine or any unusual||
1332|149|P|change in the amount of urine.||
1332|150|P|   This drug may make you dizzy or drowsy or cause blurred||
1332|151|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
1332|152|P|Do not drive, use machinery, or do anything that needs alertness||
1332|153|P|or clear vision until you can do it safely. Limit alcoholic||
1332|154|P|beverages. Talk to your doctor if you are using marijuana||
1332|155|P|(cannabis).||
1332|156|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1332|157|P|or tobacco, especially when combined with this medicine, may||
1332|158|P|increase your risk for stomach bleeding. Limit alcohol and stop||
1332|159|P|smoking.||
1332|160|P|   This medication may make you more sensitive to the sun. Limit||
1332|161|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1332|162|P|sunscreen and wear protective clothing when outdoors. Tell your||
1332|163|P|doctor right away if you get sunburned or have skin||
1332|164|P|blisters/redness.||
1332|165|P|   This medication may contain aspartame. If you have||
1332|166|P|phenylketonuria (PKU) or any other condition that requires you to||
1332|167|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
1332|168|P|doctor or pharmacist about using this medication safely.||
1332|169|P|   Before having surgery, tell your doctor or dentist about all||
1332|170|P|the products you use (including prescription drugs,||
1332|171|P|nonprescription drugs, and herbal products).||
1332|172|P|   Older adults may be at greater risk for stomach/intestinal||
1332|173|P|bleeding, kidney problems, heart attack, and stroke while using||
1332|174|P|this drug.||
1332|175|P|   Before using this medication, women of childbearing age should||
1332|176|P|talk with their doctor(s) about the benefits and risks. Tell your||
1332|177|P|doctor if you are pregnant or if you plan to become pregnant.||
1332|178|P|This medication may harm an unborn baby and cause problems with||
1332|179|P|normal labor/delivery. It is not recommended for use in pregnancy||
1332|180|P|from 20 weeks until delivery. If your doctor decides that you||
1332|181|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1332|182|P|you should use the lowest effective dose for the shortest||
1332|183|P|possible time. You should not use this medication after 30 weeks||
1332|184|P|of pregnancy.||
1332|185|P|   This medication passes into breast milk. Consult your doctor||
1332|186|P|before breastfeeding.||
1332|187|B|||
1332|188|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1332|189|I|medications work or increase your risk for serious side effects.||
1332|190|I|This document does not contain all possible drug interactions.||
1332|191|I|Keep a list of all the products you use (including||
1332|192|I|prescription/nonprescription drugs and herbal products) and share||
1332|193|I|it with your doctor and pharmacist. Do not start, stop, or change||
1332|194|I|the dosage of any medicines without your doctor's approval.||
1332|195|I|   Some products that may interact with this drug are: aliskiren,||
1332|196|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
1332|197|I|receptor blockers (such as losartan, valsartan), cidofovir,||
1332|198|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
1332|199|I|methotrexate, "water pills" (diuretics such as furosemide).||
1332|200|I|   This medication may increase the risk of bleeding when taken||
1332|201|I|with other drugs that also may cause bleeding. Examples include||
1332|202|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1332|203|I|dabigatran/enoxaparin/warfarin, among others.||
1332|204|I|   Check all prescription and nonprescription medicine labels||
1332|205|I|carefully since many medications contain pain relievers/fever||
1332|206|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
1332|207|I|naproxen). These drugs are similar to diclofenac and may increase||
1332|208|I|your risk of side effects if taken together. However, if your||
1332|209|I|doctor has told you to take low-dose aspirin to prevent heart||
1332|210|I|attack or stroke (usually 81-162 milligrams a day), you should||
1332|211|I|keep taking the aspirin unless your doctor tells you not to. Ask||
1332|212|I|your doctor or pharmacist for more details.||
1332|213|B|||
1332|214|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1332|215|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1332|216|O|poison control center right away. US residents can call||
1332|217|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1332|218|O|Symptoms of overdose may include: severe stomach pain,||
1332|219|O|slow/shallow breathing, extreme drowsiness.||
1332|220|B|||
1332|221|N|NOTES:  Do not share this medication with others.||
1332|222|N|   Lab and/or medical tests (such as complete blood count,||
1332|223|N|liver/kidney function, blood pressure) may be done while you are||
1332|224|N|using this medication. Keep all medical and lab appointments.||
1332|225|N|Consult your doctor for more details.||
1332|226|B|||
1332|227|D|MISSED DOSE:  Not applicable.||
1332|228|B|||
1332|229|R|STORAGE:  Store at room temperature away from light and moisture.||
1332|230|R|Do not store in the bathroom. Keep all medications away from||
1332|231|R|children and pets.||
1332|232|R|   Do not flush medications down the toilet or pour them into a||
1332|233|R|drain unless instructed to do so. Properly discard this product||
1332|234|R|when it is expired or no longer needed. Consult your pharmacist||
1332|235|R|or local waste company.||
1332|236|B|||
1332|237|A|Information last revised May 2024.||
1332|238|A|Copyright(c) 2025 First Databank, Inc.||
1332|239|B|||
1333|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1333|002|Z|does NOT have all possible information about this product. This||
1333|003|Z|information does not assure that this product is safe, effective,||
1333|004|Z|or appropriate for you. This information is not individual||
1333|005|Z|medical advice and does not substitute for the advice of your||
1333|006|Z|health care professional. Always ask your health care||
1333|007|Z|professional for complete information about this product and your||
1333|008|Z|specific health needs.||
1333|009|B|||
1333|010|T|CLOBETASOL SHAMPOO - TOPICAL||
1333|011|F|(kloe-BAY-ta-sol)||
1333|012|B|||
1333|013|C|COMMON BRAND NAME(S): Clobex||
1333|014|B|||
1333|015|U|USES:  Clobetasol is used by adults to treat moderate to severe||
1333|016|U|scalp psoriasis. Clobetasol reduces the swelling, itching and||
1333|017|U|redness that can occur with this condition. This medication is a||
1333|018|U|very strong (super-high-potency) corticosteroid.||
1333|019|U|   This medication is not recommended for use in children or||
1333|020|U|those less than 18 years of age due to an increased risk of side||
1333|021|U|effects. Consult your doctor or pharmacist for details.||
1333|022|B|||
1333|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1333|024|H|from your pharmacist before you start using clobetasol shampoo||
1333|025|H|and each time you get a refill. If you have any questions, ask||
1333|026|H|your doctor or pharmacist.||
1333|027|H|   This shampoo should be used only on the scalp. Avoid contact||
1333|028|H|with the eyes, nose and mouth. Do not bandage, wrap or cover the||
1333|029|H|affected area (for example, avoid using shower caps or bathing||
1333|030|H|caps) unless directed by your doctor.||
1333|031|H|   Apply a thin film of shampoo to your dry scalp by squeezing||
1333|032|H|the bottle directly over the affected area as directed by your||
1333|033|H|doctor, usually once daily. Gently rub the shampoo into the||
1333|034|H|affected area, leaving it on your scalp for 15 minutes. Wash your||
1333|035|H|hands immediately after applying the shampoo. Then wet your||
1333|036|H|scalp, lather, and rinse the shampoo off thoroughly. Also rinse||
1333|037|H|any other body parts (such as hands, face, neck, shoulders) that||
1333|038|H|may have come in contact with the shampoo. The use of another||
1333|039|H|non-medicated shampoo is not necessary to clean your hair,||
1333|040|H|although it may be used if desired.||
1333|041|H|   Do not apply this medication to your face, neck, groin, or||
1333|042|H|underarms. Avoid using this medication close to the eyes or lips.||
1333|043|H|Getting it in the eyes may worsen or cause glaucoma. If you get||
1333|044|H|the shampoo in your eyes or on your lips, rinse thoroughly with||
1333|045|H|plenty of water.||
1333|046|H|   Do not use this medication more often or for a longer period||
1333|047|H|than prescribed because the risk of side effects may be||
1333|048|H|increased. Do not use more than 50 milliliters (1.75 ounces) of||
1333|049|H|shampoo per week. Treatment with this medication should be||
1333|050|H|limited to 4 weeks. Tell your doctor if your condition does not||
1333|051|H|get better within 4 weeks.||
1333|052|B|||
1333|053|S|SIDE EFFECTS:  Burning, stinging, itching, irritation, redness,||
1333|054|S|discoloration, dry skin, hair loss, headache, or acne may occur||
1333|055|S|when this medication is first applied to the scalp. This should||
1333|056|S|disappear in a few days as your body adjusts to the medication.||
1333|057|S|If any of these effects last or get worse, notify your doctor or||
1333|058|S|pharmacist promptly.||
1333|059|S|   Remember that this medication has been prescribed because your||
1333|060|S|doctor has judged that the benefit to you is greater than the||
1333|061|S|risk of side effects. Many people using this medication do not||
1333|062|S|have serious side effects.||
1333|063|S|   Tell your doctor right away if you have any serious side||
1333|064|S|effects, including: stretch marks (striae), skin||
1333|065|S|thinning/discoloration, excessive hair growth, small red bumps on||
1333|066|S|the skin (folliculitis).||
1333|067|S|   Skin infections can become worse when using this medication.||
1333|068|S|Notify your doctor if redness, swelling or irritation does not||
1333|069|S|improve.||
1333|070|S|   Rarely, it is possible this medication will be absorbed from||
1333|071|S|the skin into the bloodstream. This can lead to side effects of||
1333|072|S|too much corticosteroid. These side effects are more likely in||
1333|073|S|children, and in people who use this medication for a long time||
1333|074|S|or over large areas of the skin. Tell your doctor right away if||
1333|075|S|any of the following side effects occur: unusual/extreme||
1333|076|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
1333|077|S|thirst/urination, vision problems.||
1333|078|S|   A very serious allergic reaction to this drug is rare.||
1333|079|S|However, get medical help right away if you notice any symptoms||
1333|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1333|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1333|082|S|breathing.||
1333|083|S|   This is not a complete list of possible side effects. If you||
1333|084|S|notice other effects not listed above, contact your doctor or||
1333|085|S|pharmacist.||
1333|086|S|   In the US -||
1333|087|S|   Call your doctor for medical advice about side effects. You||
1333|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1333|089|S|www.fda.gov/medwatch.||
1333|090|S|   In Canada - Call your doctor for medical advice about side||
1333|091|S|effects. You may report side effects to Health Canada at||
1333|092|S|1-866-234-2345.||
1333|093|B|||
1333|094|P|PRECAUTIONS:  Before using clobetasol, tell your doctor or||
1333|095|P|pharmacist if you are allergic to it; or to any other steroids||
1333|096|P|(such as hydrocortisone, dexamethasone); or if you have any other||
1333|097|P|allergies. This product may contain inactive ingredients, which||
1333|098|P|can cause allergic reactions or other problems. Talk to your||
1333|099|P|pharmacist for more details.||
1333|100|P|   Before using this medication, tell your doctor or pharmacist||
1333|101|P|your medical history, especially of: poor blood circulation,||
1333|102|P|diabetes, other skin/scalp conditions (such as rosacea, perioral||
1333|103|P|dermatitis), immune system problems.||
1333|104|P|   Do not use if there is an infection or sore in the area to be||
1333|105|P|treated.||
1333|106|P|   Rarely, using corticosteroid medications for a long time or||
1333|107|P|over large areas of skin can make it more difficult for your body||
1333|108|P|to respond to physical stress. Before having surgery or emergency||
1333|109|P|treatment, or if you get a serious illness/injury, tell your||
1333|110|P|doctor or dentist that you are using this medication or have used||
1333|111|P|this medication within the past few months.||
1333|112|P|   Though it is unlikely, this medication may temporarily slow||
1333|113|P|down a child's growth if used for a long time. See the doctor||
1333|114|P|regularly so your child's height can be checked.||
1333|115|P|   During pregnancy, this medication should be used only when||
1333|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
1333|117|P|   It is unknown if this drug passes into breast milk when||
1333|118|P|applied to the scalp/skin. Similar medications pass into breast||
1333|119|P|milk when taken by mouth. Consult your doctor before||
1333|120|P|breastfeeding.||
1333|121|B|||
1333|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1333|123|I|medications work or increase your risk for serious side effects.||
1333|124|I|This document does not contain all possible drug interactions.||
1333|125|I|Keep a list of all the products you use (including||
1333|126|I|prescription/nonprescription drugs and herbal products) and share||
1333|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
1333|128|I|the dosage of any medicines without your doctor's approval.||
1333|129|B|||
1333|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1333|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1333|132|O|poison control center right away. US residents can call||
1333|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
1333|134|O|medicine may be harmful if swallowed.||
1333|135|B|||
1333|136|N|NOTES:  Do not share this medication with others. This medication||
1333|137|N|has been prescribed for your current condition only. Do not use||
1333|138|N|it later for other skin problems unless told to do so by your||
1333|139|N|doctor. A different medication may be necessary in those cases.||
1333|140|N|   Lab and/or medical tests (such as adrenal gland function) may||
1333|141|N|be done while you are using this medication, especially if you||
1333|142|N|use this drug for an extended period of time or apply it over||
1333|143|N|large areas of the body. Keep all medical and lab appointments.||
1333|144|N|Consult your doctor for more details.||
1333|145|B|||
1333|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1333|147|D|If it is near the time of the next dose, skip the missed dose.||
1333|148|D|Use your next dose at the regular time. Do not double the dose to||
1333|149|D|catch up.||
1333|150|B|||
1333|151|R|STORAGE:  Store at room temperature. Keep all medications away||
1333|152|R|from children and pets.||
1333|153|R|   Do not flush medications down the toilet or pour them into a||
1333|154|R|drain unless instructed to do so. Properly discard this product||
1333|155|R|when it is expired or no longer needed. Consult your pharmacist||
1333|156|R|or local waste disposal company.||
1333|157|B|||
1333|158|A|Information last revised November 2024.||
1333|159|A|Copyright(c) 2025 First Databank, Inc.||
1333|160|B|||
1335|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1335|002|Z|does NOT have all possible information about this product. This||
1335|003|Z|information does not assure that this product is safe, effective,||
1335|004|Z|or appropriate for you. This information is not individual||
1335|005|Z|medical advice and does not substitute for the advice of your||
1335|006|Z|health care professional. Always ask your health care||
1335|007|Z|professional for complete information about this product and your||
1335|008|Z|specific health needs.||
1335|009|B|||
1335|010|T|DENOSUMAB - INJECTION||
1335|011|F|(den-OH-sue-mab)||
1335|012|B|||
1335|013|C|COMMON BRAND NAME(S): Bildyos, Conexxence, Jubbonti, Ospomyv,||
1335|014|C|Prolia, Stoboclo||
1335|015|B|||
1335|016|W|WARNING:  Denosumab may cause serious (rarely fatal) low calcium||
1335|017|W|levels and may also worsen low calcium levels, especially if you||
1335|018|W|have kidney problems. You may also be at increased risk if you||
1335|019|W|have a history of low blood calcium levels (hypocalcemia),||
1335|020|W|thyroid/parathyroid problems/surgery, or stomach/intestinal||
1335|021|W|problems (such as malabsorption/surgery). Take calcium and||
1335|022|W|vitamin D as directed by your doctor to help prevent low levels||
1335|023|W|of calcium. Your doctor will order blood tests before your first||
1335|024|W|injection and during treatment to monitor you closely. Tell your||
1335|025|W|doctor right away if you have any symptoms of low calcium such as||
1335|026|W|severe muscle spasms/cramps, mental/mood changes (such as||
1335|027|W|irritability or confusion), numbness/tingling (especially around||
1335|028|W|lips/mouth or in fingers/toes), fast/irregular heartbeat, severe||
1335|029|W|dizziness/fainting, or seizures.||
1335|030|B|||
1335|031|U|USES:  Denosumab is used to treat bone loss (osteoporosis) in||
1335|032|U|people who have a high risk of getting fractures. Osteoporosis||
1335|033|U|causes bones to become thinner and break more easily. Your chance||
1335|034|U|of developing osteoporosis increases after menopause (in women),||
1335|035|U|as you age, if someone in your family has osteoporosis, or if you||
1335|036|U|take certain medications (such as prednisone) for long periods.||
1335|037|U|   This medication works by slowing bone loss to help maintain||
1335|038|U|strong bones and reduce the risk of broken bones (fractures).||
1335|039|U|Denosumab belongs to a class of drugs called monoclonal||
1335|040|U|antibodies. It prevents certain cells in the body (osteoclasts)||
1335|041|U|from breaking down bone.||
1335|042|U|   This monograph is about the following denosumab products:||
1335|043|U|denosumab, denosumab-bbdz, denosumab-bmwo, denosumab-bnht,||
1335|044|U|denosumab-dssb, and denosumab-nxxp.||
1335|045|B|||
1335|046|H|HOW TO USE:  Read the Medication Guide provided by your||
1335|047|H|pharmacist before you start using denosumab and before each||
1335|048|H|injection. If you have any questions, ask your doctor or||
1335|049|H|pharmacist.||
1335|050|H|   This medication is given by injection under the skin in the||
1335|051|H|upper arm, upper thigh, or abdomen by a healthcare professional.||
1335|052|H|It is given as directed by your doctor, usually once every 6||
1335|053|H|months.||
1335|054|H|   You may also be instructed to take calcium and vitamin D||
1335|055|H|supplements. Follow your doctor's instructions carefully.||
1335|056|H|   Use this medication regularly to get the most benefit from it.||
1335|057|H|Keep receiving this medication even if you feel well. Most people||
1335|058|H|with osteoporosis do not have symptoms. To help you remember,||
1335|059|H|mark your calendar with a reminder.||
1335|060|B|||
1335|061|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
1335|062|S|   Remember that this medication has been prescribed because your||
1335|063|S|doctor has judged that the benefit to you is greater than the||
1335|064|S|risk of side effects. Many people using this medication do not||
1335|065|S|have serious side effects.||
1335|066|S|   Denosumab can affect your immune system. You may be more||
1335|067|S|likely to get a serious infection, such as a skin, ear,||
1335|068|S|stomach/gut, or bladder infection. Tell your doctor right away if||
1335|069|S|you develop any signs of infection, such as: fever/chills,||
1335|070|S|red/swollen/tender/warm skin (with or without pus), severe||
1335|071|S|abdominal pain, ear pain/discharge, trouble hearing,||
1335|072|S|frequent/painful/burning urination, pink/bloody urine.||
1335|073|S|   Tell your doctor right away if you have any serious side||
1335|074|S|effects, including: jaw pain, new or unusual thigh/hip/groin||
1335|075|S|pain, bone/joint/muscle pain.||
1335|076|S|   After your treatment with denosumab is stopped, you may be at||
1335|077|S|increased risk for bone fracture, including bones in your spine.||
1335|078|S|Do not stop using this medication without first talking with your||
1335|079|S|doctor. If your treatment is stopped, talk with your doctor about||
1335|080|S|other medicines you can take.||
1335|081|S|   A very serious allergic reaction to this drug is rare.||
1335|082|S|However, get medical help right away if you notice any symptoms||
1335|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1335|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1335|085|S|breathing.||
1335|086|S|   Denosumab can cause skin problems such as dryness, peeling,||
1335|087|S|redness, itching, small bumps/patches, or blisters. However, you||
1335|088|S|may not be able to tell it apart from a rare rash that could be a||
1335|089|S|sign of a severe allergic reaction. Get medical help right away||
1335|090|S|if you develop any rash or if any of these symptoms last or get||
1335|091|S|worse.||
1335|092|S|   This is not a complete list of possible side effects. If you||
1335|093|S|notice other effects not listed above, contact your doctor or||
1335|094|S|pharmacist.||
1335|095|S|   In the US -||
1335|096|S|   Call your doctor for medical advice about side effects. You||
1335|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1335|098|S|www.fda.gov/medwatch.||
1335|099|S|   In Canada - Call your doctor for medical advice about side||
1335|100|S|effects. You may report side effects to Health Canada at||
1335|101|S|1-866-234-2345.||
1335|102|B|||
1335|103|P|PRECAUTIONS:  See also Warning section.||
1335|104|P|   Before using denosumab, tell your doctor or pharmacist if you||
1335|105|P|are allergic to it; or to other denosumab products; or if you||
1335|106|P|have any other allergies. This product may contain inactive||
1335|107|P|ingredients, which can cause allergic reactions or other||
1335|108|P|problems. Talk to your pharmacist for more details.||
1335|109|P|   Before using this medication, tell your doctor or pharmacist||
1335|110|P|your medical history, especially of: recent or planned dental||
1335|111|P|surgery/tooth removal.||
1335|112|P|   Some people using denosumab may have serious jawbone problems.||
1335|113|P|Your doctor should check your mouth before you start this||
1335|114|P|medication. Tell your dentist that you are using this medication||
1335|115|P|before you have any dental work done. To help prevent jawbone||
1335|116|P|problems, have regular dental exams and learn how to keep your||
1335|117|P|teeth and gums healthy. If you have jaw pain, tell your doctor||
1335|118|P|and dentist right away.||
1335|119|P|   Before having any surgery (especially dental procedures), tell||
1335|120|P|your doctor and dentist about this medication and all other||
1335|121|P|products you use (including prescription drugs, nonprescription||
1335|122|P|drugs, and herbal products).||
1335|123|P|   Denosumab is not recommended for use in children. It may slow||
1335|124|P|down a child's growth and affect tooth development.||
1335|125|P|   This medication must not be used during pregnancy. It may harm||
1335|126|P|an unborn baby. Your doctor should order a pregnancy test before||
1335|127|P|you start this medication. It is important to prevent pregnancy||
1335|128|P|while using this medication and for at least 5 months after||
1335|129|P|treatment. Females must use reliable forms of birth control||
1335|130|P|during treatment and for at least 5 months after treatment. If||
1335|131|P|you become pregnant or think you may be pregnant, tell your||
1335|132|P|doctor right away.||
1335|133|P|   It is unknown if this medication passes into breast milk.||
1335|134|P|Consult your doctor before breastfeeding.||
1335|135|B|||
1335|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1335|137|I|medications work or increase your risk for serious side effects.||
1335|138|I|This document does not contain all possible drug interactions.||
1335|139|I|Keep a list of all the products you use (including||
1335|140|I|prescription/nonprescription drugs and herbal products) and share||
1335|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
1335|142|I|the dosage of any medicines without your doctor's approval.||
1335|143|B|||
1335|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1335|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1335|146|O|poison control center right away. US residents can call||
1335|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1335|148|B|||
1335|149|N|NOTES:  Do not share this medication with others.||
1335|150|N|   Lifestyle changes that help promote healthy bones include||
1335|151|N|increasing weight-bearing exercise, stopping smoking, limiting||
1335|152|N|alcohol, and eating well-balanced meals that contain adequate||
1335|153|N|calcium and vitamin D. Since you may also need to take calcium||
1335|154|N|and vitamin D supplements and make other lifestyle changes,||
1335|155|N|consult your doctor for specific advice.||
1335|156|N|   Lab and/or medical tests (such as bone density tests,||
1335|157|N|calcium/phosphorus/magnesium levels, kidney function) should be||
1335|158|N|done before you start using this medication and while you are||
1335|159|N|using it. Keep all medical and lab appointments. Consult your||
1335|160|N|doctor for more details.||
1335|161|N|   Do not take this medication with any other product that||
1335|162|N|contains denosumab.||
1335|163|B|||
1335|164|D|MISSED DOSE:  It is important to get each dose of this medication||
1335|165|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1335|166|D|right away for a new dosing schedule.||
1335|167|B|||
1335|168|R|STORAGE:  This medication is given in a hospital or clinic or||
1335|169|R|doctor's office and usually will not be stored at home.||
1335|170|R|   If you are picking up this medication at the pharmacy to bring||
1335|171|R|to your medical appointment, store in the refrigerator until the||
1335|172|R|day of your appointment. If you have any questions about storage,||
1335|173|R|ask your pharmacist. Keep all medications away from children and||
1335|174|R|pets.||
1335|175|R|   Do not flush medications down the toilet or pour them into a||
1335|176|R|drain unless instructed to do so. Properly discard this product||
1335|177|R|when it is expired or no longer needed. Consult your pharmacist||
1335|178|R|or local waste disposal company.||
1335|179|B|||
1335|180|A|Information last revised October 2025.||
1335|181|A|Copyright(c) 2025 First Databank, Inc.||
1335|182|B|||
1336|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1336|002|Z|does NOT have all possible information about this product. This||
1336|003|Z|information does not assure that this product is safe, effective,||
1336|004|Z|or appropriate for you. This information is not individual||
1336|005|Z|medical advice and does not substitute for the advice of your||
1336|006|Z|health care professional. Always ask your health care||
1336|007|Z|professional for complete information about this product and your||
1336|008|Z|specific health needs.||
1336|009|B|||
1336|010|T|ILOPROST SOLUTION - INHALATION||
1336|011|F|(EYE-loe-prost)||
1336|012|B|||
1336|013|C|COMMON BRAND NAME(S): Ventavis||
1336|014|B|||
1336|015|U|USES:  This medication is used to treat a type of high blood||
1336|016|U|pressure in the lungs (pulmonary arterial hypertension). Iloprost||
1336|017|U|helps to increase your ability to exercise and improves symptoms||
1336|018|U|such as shortness of breath and tiredness. It works by relaxing||
1336|019|U|and widening the blood vessels (arteries) in the lungs and other||
1336|020|U|parts of the body so that blood can flow more easily. This||
1336|021|U|medication belongs to a class of drugs known as vasodilators.||
1336|022|B|||
1336|023|H|HOW TO USE:  Read the Patient Information Leaflet available from||
1336|024|H|your pharmacist. This medication comes in a glass bottle||
1336|025|H|(ampule). Follow the manufacturer's instructions on how to open||
1336|026|H|the ampule and how to prepare each dose. This product is used||
1336|027|H|with a special breathing device (nebulizer). Ask your doctor,||
1336|028|H|pharmacist or respiratory therapist how to inhale this medication||
1336|029|H|properly with this equipment. Make sure you understand how to||
1336|030|H|properly clean the nebulizer to prevent infections.||
1336|031|H|   Before using, check this product for particles or||
1336|032|H|discoloration. If either is present, do not use the liquid. Do||
1336|033|H|not mix with other medications in the nebulizer.||
1336|034|H|   Inhale this medication by mouth as directed by your doctor,||
1336|035|H|usually 6 to 9 times daily, at least 2 hours apart. Do not drink||
1336|036|H|the solution. Do not get this medication on the skin or in your||
1336|037|H|eyes. If this happens, rinse the area with water. The dosage is||
1336|038|H|based on your medical condition and response to treatment.||
1336|039|H|   Use this medication regularly to get the most benefit from it.||
1336|040|H|To help you remember, use it at the same times each day.||
1336|041|H|   To avoid not being able to use your medication, be sure to||
1336|042|H|have access to a backup nebulizer in case your regular device||
1336|043|H|stops working properly.||
1336|044|H|   Tell your doctor if your condition does not get better or if||
1336|045|H|it gets worse.||
1336|046|B|||
1336|047|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, dizziness,||
1336|048|S|jaw pain, muscle spasms of the jaw, flushing, or trouble sleeping||
1336|049|S|may occur. If any of these effects last or get worse, tell your||
1336|050|S|doctor or pharmacist promptly.||
1336|051|S|   To reduce the risk of dizziness and lightheadedness, get up||
1336|052|S|slowly when rising from a sitting or lying position.||
1336|053|S|   Remember that this medication has been prescribed because your||
1336|054|S|doctor has judged that the benefit to you is greater than the||
1336|055|S|risk of side effects. Many people using this medication do not||
1336|056|S|have serious side effects.||
1336|057|S|   Tell your doctor right away if you have any serious side||
1336|058|S|effects, including: wheezing, sudden weight gain, worsening||
1336|059|S|breathing, chest pain, fainting.||
1336|060|S|   A very serious allergic reaction to this drug is rare.||
1336|061|S|However, get medical help right away if you notice any symptoms||
1336|062|S|of a serious allergic reaction, including: rash, itching/swelling||
1336|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1336|064|S|breathing.||
1336|065|S|   This is not a complete list of possible side effects. If you||
1336|066|S|notice other effects not listed above, contact your doctor or||
1336|067|S|pharmacist.||
1336|068|S|   In the US -||
1336|069|S|   Call your doctor for medical advice about side effects. You||
1336|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1336|071|S|www.fda.gov/medwatch.||
1336|072|S|   In Canada - Call your doctor for medical advice about side||
1336|073|S|effects. You may report side effects to Health Canada at||
1336|074|S|1-866-234-2345.||
1336|075|B|||
1336|076|P|PRECAUTIONS:  Before using iloprost, tell your doctor or||
1336|077|P|pharmacist if you are allergic to it; or if you have any other||
1336|078|P|allergies. This product may contain inactive ingredients, which||
1336|079|P|can cause allergic reactions or other problems. Talk to your||
1336|080|P|pharmacist for more details.||
1336|081|P|   Before using this medication, tell your doctor or pharmacist||
1336|082|P|your medical history, especially of: low blood pressure, bleeding||
1336|083|P|problems, other breathing problems (such as asthma).||
1336|084|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1336|085|P|can make you more dizzy. Do not drive, use machinery, or do||
1336|086|P|anything that needs alertness until you can do it safely. Limit||
1336|087|P|alcoholic beverages. Talk to your doctor if you are using||
1336|088|P|marijuana (cannabis).||
1336|089|P|   Before having surgery, tell your doctor or dentist about all||
1336|090|P|the products you use (including prescription drugs,||
1336|091|P|nonprescription drugs, and herbal products).||
1336|092|P|   During pregnancy, this medication should be used only when||
1336|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
1336|094|P|   It is unknown if this medication passes into breast milk.||
1336|095|P|Because of the possible risk to the infant, breastfeeding is not||
1336|096|P|recommended while using this medication. Consult your doctor||
1336|097|P|before breastfeeding.||
1336|098|B|||
1336|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1336|100|I|medications work or increase your risk for serious side effects.||
1336|101|I|This document does not contain all possible drug interactions.||
1336|102|I|Keep a list of all the products you use (including||
1336|103|I|prescription/nonprescription drugs and herbal products) and share||
1336|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1336|105|I|the dosage of any medicines without your doctor's approval.||
1336|106|B|||
1336|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1336|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1336|109|O|poison control center right away. US residents can call||
1336|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1336|111|O|Symptoms of overdose may include: severe dizziness, fainting.||
1336|112|B|||
1336|113|N|NOTES:  Do not share this medication with others.||
1336|114|N|   Lab and/or medical tests (such as blood pressure, liver||
1336|115|N|function) may be done while you are using this medication. Keep||
1336|116|N|all medical and lab appointments. Consult your doctor for more||
1336|117|N|details.||
1336|118|B|||
1336|119|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1336|120|D|If it is near the time of the next dose, skip the missed dose.||
1336|121|D|Use your next dose at the regular time. Do not double the dose to||
1336|122|D|catch up.||
1336|123|B|||
1336|124|R|STORAGE:  Store at room temperature. Keep all medications away||
1336|125|R|from children and pets.||
1336|126|R|   Do not flush medications down the toilet or pour them into a||
1336|127|R|drain unless instructed to do so. Properly discard this product||
1336|128|R|when it is expired or no longer needed. Consult your pharmacist||
1336|129|R|or local waste disposal company.||
1336|130|B|||
1336|131|A|Information last revised January 2025.||
1336|132|A|Copyright(c) 2025 First Databank, Inc.||
1336|133|B|||
1337|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1337|002|Z|does NOT have all possible information about this product. This||
1337|003|Z|information does not assure that this product is safe, effective,||
1337|004|Z|or appropriate for you. This information is not individual||
1337|005|Z|medical advice and does not substitute for the advice of your||
1337|006|Z|health care professional. Always ask your health care||
1337|007|Z|professional for complete information about this product and your||
1337|008|Z|specific health needs.||
1337|009|B|||
1337|010|T|DUTASTERIDE/TAMSULOSIN - ORAL||
1337|011|F|(doo-TAS-ter-ide/tam-SOO-loe-sin)||
1337|012|B|||
1337|013|C|COMMON BRAND NAME(S): Jalyn||
1337|014|B|||
1337|015|U|USES:  This product is used in men to treat the symptoms of an||
1337|016|U|enlarged prostate (benign prostatic hyperplasia-BPH). Dutasteride||
1337|017|U|works by reducing the size of the enlarged prostate. Tamsulosin||
1337|018|U|is known as an alpha-blocker and works by relaxing muscles in the||
1337|019|U|bladder and prostate. This product helps to relieve symptoms of||
1337|020|U|BPH such as difficulty in beginning the flow of urine, weak||
1337|021|U|stream, and the need to urinate often or urgently (including||
1337|022|U|during the middle of the night).||
1337|023|U|   Dutasteride is not approved for prevention of prostate cancer.||
1337|024|U|It may slightly increase the risk of developing a very serious||
1337|025|U|form of prostate cancer. Talk to your doctor about the benefits||
1337|026|U|and risks.||
1337|027|U|   This medication should not be used by women or children.||
1337|028|B|||
1337|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1337|030|H|from your pharmacist before you start taking this medication and||
1337|031|H|each time you get a refill. If you have any questions, ask your||
1337|032|H|doctor or pharmacist.||
1337|033|H|   Take this medication by mouth as directed by your doctor,||
1337|034|H|usually once daily, 30 minutes after the same meal each day.||
1337|035|H|Swallow this medication whole. Do not crush, chew, or open the||
1337|036|H|capsules.||
1337|037|H|   This medication may cause a sudden drop in your blood||
1337|038|H|pressure, which could lead to dizziness or fainting. This risk is||
1337|039|H|higher when you first start taking this drug or if you restart||
1337|040|H|treatment after you stop taking it. During these times, avoid||
1337|041|H|situations where you may be injured if you faint.||
1337|042|H|   Take this medication regularly in order to get the most||
1337|043|H|benefit from it. To help you remember, take it at the same time||
1337|044|H|each day.||
1337|045|H|   Since this drug can be absorbed through the skin and may harm||
1337|046|H|an unborn baby, women who are pregnant or who may become pregnant||
1337|047|H|should not handle this medication.||
1337|048|H|   It may take up to 4 weeks to notice an improvement in||
1337|049|H|symptoms. Tell your doctor if your symptoms do not get better||
1337|050|H|after 4 weeks or if they get worse.||
1337|051|B|||
1337|052|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness,||
1337|053|S|runny/stuffy nose, sexual problems (such as decreased sexual||
1337|054|S|interest/ability, ejaculation problems, decrease in the amount of||
1337|055|S|semen/sperm), testicle pain/swelling, increased breast size, or||
1337|056|S|breast tenderness may occur. Sexual problems have continued in||
1337|057|S|some men even after stopping treatment. If any of these effects||
1337|058|S|last or get worse, tell your doctor or pharmacist promptly.||
1337|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
1337|060|S|slowly when rising from a sitting or lying position.||
1337|061|S|   Remember that this medication has been prescribed because your||
1337|062|S|doctor has judged that the benefit to you is greater than the||
1337|063|S|risk of side effects. Many people using this medication do not||
1337|064|S|have serious side effects.||
1337|065|S|   Tell your doctor right away if you have any serious side||
1337|066|S|effects, including: fainting.||
1337|067|S|   Rarely, males may have a painful or prolonged erection lasting||
1337|068|S|4 or more hours. If this occurs, stop using this drug and get||
1337|069|S|medical help right away, or permanent problems could occur.||
1337|070|S|   A very serious allergic reaction to this drug is rare.||
1337|071|S|However, get medical help right away if you notice any symptoms||
1337|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1337|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1337|074|S|breathing.||
1337|075|S|   This is not a complete list of possible side effects. If you||
1337|076|S|notice other effects not listed above, contact your doctor or||
1337|077|S|pharmacist.||
1337|078|S|   In the US -||
1337|079|S|   Call your doctor for medical advice about side effects. You||
1337|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1337|081|S|www.fda.gov/medwatch.||
1337|082|S|   In Canada - Call your doctor for medical advice about side||
1337|083|S|effects. You may report side effects to Health Canada at||
1337|084|S|1-866-234-2345.||
1337|085|B|||
1337|086|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1337|087|P|pharmacist if you are allergic to dutasteride or tamsulosin; or||
1337|088|P|to finasteride; or if you have any other allergies. This product||
1337|089|P|may contain inactive ingredients, which can cause allergic||
1337|090|P|reactions or other problems. Talk to your pharmacist for more||
1337|091|P|details.||
1337|092|P|   Before using this medication, tell your doctor or pharmacist||
1337|093|P|your medical history, especially of: low blood pressure, certain||
1337|094|P|eye problems (cataracts, glaucoma).||
1337|095|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1337|096|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1337|097|P|machinery, or do anything that needs alertness until you can do||
1337|098|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1337|099|P|are using marijuana (cannabis).||
1337|100|P|   Before having surgery (including cataract/glaucoma eye||
1337|101|P|surgery), tell your doctor or dentist if you are taking or have||
1337|102|P|ever taken this medication, and about all the other products you||
1337|103|P|use (including prescription drugs, nonprescription drugs, and||
1337|104|P|herbal products).||
1337|105|P|   Older adults may be more sensitive to the side effects of this||
1337|106|P|drug, especially dizziness and low blood pressure when getting up||
1337|107|P|from a sitting or lying position. These side effects can increase||
1337|108|P|the risk of falling.||
1337|109|P|   Do not donate blood while you are taking this medication and||
1337|110|P|for at least 6 months after you stop taking it. This will prevent||
1337|111|P|the possibility of your blood being given to a pregnant woman.||
1337|112|P|   This medication should not be used in women, especially during||
1337|113|P|pregnancy or breastfeeding. It may harm an unborn baby or||
1337|114|P|breastfeeding baby. Consult your doctor for more details.||
1337|115|B|||
1337|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1337|117|I|medications work or increase your risk for serious side effects.||
1337|118|I|This document does not contain all possible drug interactions.||
1337|119|I|Keep a list of all the products you use (including||
1337|120|I|prescription/nonprescription drugs and herbal products) and share||
1337|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
1337|122|I|the dosage of any medicines without your doctor's approval.||
1337|123|I|   Some products that may interact with this drug include: other||
1337|124|I|alpha blocker drugs (such as prazosin, terazosin).||
1337|125|I|   If you are also taking a drug to treat erectile dysfunction-ED||
1337|126|I|or pulmonary hypertension (such as sildenafil, tadalafil), your||
1337|127|I|blood pressure may get too low which can lead to dizziness or||
1337|128|I|fainting. Your doctor may need to adjust your medications to||
1337|129|I|minimize this risk.||
1337|130|I|   Other medications can affect the removal of this product from||
1337|131|I|your body, which may affect how this product works. Examples||
1337|132|I|include adagrasib, azole antifungals (such as itraconazole,||
1337|133|I|ketoconazole), clarithromycin, cobicistat, HIV protease||
1337|134|I|inhibitors (such as lopinavir), mifepristone, ribociclib,||
1337|135|I|ritonavir, among others.||
1337|136|B|||
1337|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1337|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1337|139|O|poison control center right away. US residents can call||
1337|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1337|141|O|Symptoms of overdose may include: severe dizziness, fainting.||
1337|142|B|||
1337|143|N|NOTES:  Do not share this medication with others.||
1337|144|N|   Lab and/or medical tests (such as prostate exams,||
1337|145|N|prostate-specific antigen-PSA) should be done while you are||
1337|146|N|taking this medication. Keep all medical and lab appointments.||
1337|147|N|Consult your doctor for more details.||
1337|148|B|||
1337|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1337|150|D|remember. If it is near the time of the next dose, skip the||
1337|151|D|missed dose. Take your next dose at the regular time. Do not||
1337|152|D|double the dose to catch up.||
1337|153|B|||
1337|154|R|STORAGE:  Store at room temperature away from light and moisture.||
1337|155|R|Do not store in the bathroom. Keep all medications away from||
1337|156|R|children and pets.||
1337|157|R|   The capsules may soften and leak if stored at high||
1337|158|R|temperatures. If your capsules change color/shape or leak, do not||
1337|159|R|use them. If your skin comes in contact with the deformed or||
1337|160|R|leaking capsules, wash the area right away with soap and water.||
1337|161|R|Contact your pharmacist for more information.||
1337|162|R|   Do not flush medications down the toilet or pour them into a||
1337|163|R|drain unless instructed to do so. Properly discard this product||
1337|164|R|when it is expired or no longer needed. Consult your pharmacist||
1337|165|R|or local waste disposal company.||
1337|166|B|||
1337|167|A|Information last revised November 2024.||
1337|168|A|Copyright(c) 2025 First Databank, Inc.||
1337|169|B|||
1338|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1338|002|Z|does NOT have all possible information about this product. This||
1338|003|Z|information does not assure that this product is safe, effective,||
1338|004|Z|or appropriate for you. This information is not individual||
1338|005|Z|medical advice and does not substitute for the advice of your||
1338|006|Z|health care professional. Always ask your health care||
1338|007|Z|professional for complete information about this product and your||
1338|008|Z|specific health needs.||
1338|009|B|||
1338|010|T|TREPROSTINIL SOLUTION - INHALATION||
1338|011|F|(tre-PROS-ti-nil)||
1338|012|B|||
1338|013|C|COMMON BRAND NAME(S): Tyvaso||
1338|014|B|||
1338|015|U|USES:  This medication is used to treat a type of high blood||
1338|016|U|pressure in the lungs (pulmonary arterial hypertension).||
1338|017|U|Treprostinil helps to increase your ability to exercise and||
1338|018|U|improves symptoms such as shortness of breath and tiredness. It||
1338|019|U|works by relaxing and widening the blood vessels (arteries) in||
1338|020|U|the lungs and other parts of the body so that blood can flow more||
1338|021|U|easily. This medication belongs to a class of drugs known as||
1338|022|U|vasodilators.||
1338|023|B|||
1338|024|H|HOW TO USE:  Read the Instructions for Use provided by your||
1338|025|H|pharmacist before you start using this medication and each time||
1338|026|H|you get a refill. Follow the illustrated directions for the||
1338|027|H|proper use of this medication. If you have any questions, ask||
1338|028|H|your doctor or pharmacist.||
1338|029|H|   This medication comes in a plastic container called an ampule||
1338|030|H|and is used with a special breathing device (nebulizer). Consult||
1338|031|H|your doctor, pharmacist or respiratory therapist on how to inhale||
1338|032|H|this medication properly with the nebulizer. Make sure you||
1338|033|H|understand how to properly clean the nebulizer to prevent||
1338|034|H|infections. If you have any questions, consult your health care||
1338|035|H|professional.||
1338|036|H|   Before using, check this product for particles or||
1338|037|H|discoloration. If either is present, do not use the liquid. Do||
1338|038|H|not mix with other inhaled medications in the nebulizer.||
1338|039|H|   Inhale this medication by mouth as directed by your doctor,||
1338|040|H|usually 4 times daily during waking hours, at least 4 hours||
1338|041|H|apart. Do not drink the solution. Do not get this medication on||
1338|042|H|the skin or in your eye. If this happens, rinse the area with||
1338|043|H|water. The dosage is based on your medical condition and response||
1338|044|H|to treatment.||
1338|045|H|   Use this medication regularly to get the most benefit from it.||
1338|046|H|To help you remember, use it at the same times each day.||
1338|047|H|   To avoid missing doses, be sure to have a backup nebulizer in||
1338|048|H|case your regular device stops working properly.||
1338|049|H|   Tell your doctor if your condition does not get better or if||
1338|050|H|it gets worse.||
1338|051|B|||
1338|052|S|SIDE EFFECTS:  Cough, headache, throat irritation, nausea,||
1338|053|S|flushing, dizziness, or jaw/muscle/bone pain may occur. If any of||
1338|054|S|these effects last or get worse, tell your doctor or pharmacist||
1338|055|S|promptly. Fainting is another common side effect. If fainting||
1338|056|S|does occur, get medical help right away.||
1338|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
1338|058|S|slowly when rising from a sitting or lying position.||
1338|059|S|   Remember that this medication has been prescribed because your||
1338|060|S|doctor has judged that the benefit to you is greater than the||
1338|061|S|risk of side effects. Many people using this medication do not||
1338|062|S|have serious side effects.||
1338|063|S|   Tell your doctor right away if you have any serious side||
1338|064|S|effects, including: unusual bleeding/bruising.||
1338|065|S|   A very serious allergic reaction to this drug is rare.||
1338|066|S|However, get medical help right away if you notice any symptoms||
1338|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1338|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1338|069|S|breathing.||
1338|070|S|   This is not a complete list of possible side effects. If you||
1338|071|S|notice other effects not listed above, contact your doctor or||
1338|072|S|pharmacist.||
1338|073|S|   In the US -||
1338|074|S|   Call your doctor for medical advice about side effects. You||
1338|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1338|076|S|www.fda.gov/medwatch.||
1338|077|S|   In Canada - Call your doctor for medical advice about side||
1338|078|S|effects. You may report side effects to Health Canada at||
1338|079|S|1-866-234-2345.||
1338|080|B|||
1338|081|P|PRECAUTIONS:  Before using treprostinil, tell your doctor or||
1338|082|P|pharmacist if you are allergic to it; or if you have any other||
1338|083|P|allergies. This product may contain inactive ingredients, which||
1338|084|P|can cause allergic reactions or other problems. Talk to your||
1338|085|P|pharmacist for more details.||
1338|086|P|   Before using this medication, tell your doctor or pharmacist||
1338|087|P|your medical history, especially of: low blood pressure, liver||
1338|088|P|problems, bleeding problems, other breathing problems (such as||
1338|089|P|asthma, chronic obstructive pulmonary disease-COPD).||
1338|090|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1338|091|P|can make you more dizzy. Do not drive, use machinery, or do||
1338|092|P|anything that needs alertness until you can do it safely. Limit||
1338|093|P|alcoholic beverages. Talk to your doctor if you are using||
1338|094|P|marijuana (cannabis).||
1338|095|P|   Before having surgery, tell your doctor or dentist about all||
1338|096|P|the products you use (including prescription drugs,||
1338|097|P|nonprescription drugs, and herbal products).||
1338|098|P|   During pregnancy, this medication should be used only when||
1338|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
1338|100|P|   This medication passes into breast milk. Consult your doctor||
1338|101|P|before breastfeeding.||
1338|102|B|||
1338|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1338|104|I|medications work or increase your risk for serious side effects.||
1338|105|I|This document does not contain all possible drug interactions.||
1338|106|I|Keep a list of all the products you use (including||
1338|107|I|prescription/nonprescription drugs and herbal products) and share||
1338|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
1338|109|I|the dosage of any medicines without your doctor's approval.||
1338|110|B|||
1338|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1338|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1338|113|O|poison control center right away. US residents can call||
1338|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1338|115|O|Symptoms of overdose may include: severe dizziness, fainting.||
1338|116|B|||
1338|117|N|NOTES:  Do not share this medication with others.||
1338|118|N|   Lab and/or medical tests (such as blood pressure) may be done||
1338|119|N|while you are using this medication. Keep all medical and lab||
1338|120|N|appointments. Consult your doctor for more details.||
1338|121|B|||
1338|122|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1338|123|D|If it is near the time of the next dose, skip the missed dose.||
1338|124|D|Use your next dose at the regular time. Do not double the dose to||
1338|125|D|catch up.||
1338|126|B|||
1338|127|R|STORAGE:  Store at room temperature away from light and moisture.||
1338|128|R|Once the foil pack is opened, this medication expires after 7||
1338|129|R|days. After an ampule has been opened, discard any unused||
1338|130|R|solution at the end of the day. Keep all medications away from||
1338|131|R|children and pets.||
1338|132|R|   Do not flush medications down the toilet or pour them into a||
1338|133|R|drain unless instructed to do so. Properly discard this product||
1338|134|R|when it is expired or no longer needed. Consult your pharmacist||
1338|135|R|or local waste disposal company.||
1338|136|B|||
1338|137|A|Information last revised August 2025.||
1338|138|A|Copyright(c) 2025 First Databank, Inc.||
1338|139|B|||
1339|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1339|002|Z|does NOT have all possible information about this product. This||
1339|003|Z|information does not assure that this product is safe, effective,||
1339|004|Z|or appropriate for you. This information is not individual||
1339|005|Z|medical advice and does not substitute for the advice of your||
1339|006|Z|health care professional. Always ask your health care||
1339|007|Z|professional for complete information about this product and your||
1339|008|Z|specific health needs.||
1339|009|B|||
1339|010|T|MICONAZOLE TABLET - BUCCAL||
1339|011|F|(mye-KON-a-zole)||
1339|012|B|||
1339|013|C|COMMON BRAND NAME(S): Oravig||
1339|014|B|||
1339|015|U|USES:  This medication is used to treat fungal infection in the||
1339|016|U|mouth or throat. Miconazole is known as an azole antifungal drug.||
1339|017|U|It works by stopping the growth of fungus.||
1339|018|B|||
1339|019|H|HOW TO USE:  Read the Patient Information Leaflet and||
1339|020|H|Instructions for Use if available from your pharmacist before you||
1339|021|H|start using miconazole and each time you get a refill. If you||
1339|022|H|have any questions, ask your doctor or pharmacist.||
1339|023|H|   Use this medication by mouth as directed by your doctor,||
1339|024|H|usually once daily in the morning, after brushing your teeth.||
1339|025|H|Before applying the tablet, locate the area in your mouth at||
1339|026|H|which to place the tablet. It should be placed at the upper gum,||
1339|027|H|just above the left or right incisor tooth. The incisors are the||
1339|028|H|teeth just to the left and right of your two front teeth. With||
1339|029|H|dry hands, place one tablet in your mouth with the round side||
1339|030|H|facing against your gum and gently push it into place. Remove||
1339|031|H|your hand from inside your mouth and apply a slight pressure with||
1339|032|H|your finger on the outside of your upper lip for 30 seconds. This||
1339|033|H|will make the tablet stick to your gum. Leave the tablet in place||
1339|034|H|until it is dissolved (usually 6 hours or longer). You may eat||
1339|035|H|and drink while using this medication. Do not crush, chew or||
1339|036|H|swallow the tablet. Check if the tablet is still in place after||
1339|037|H|you brush your teeth, rinse your mouth, eat, or drink. Before||
1339|038|H|applying the next dose, clear away any remaining tablet pieces.||
1339|039|H|Change sides of the mouth with each dose.||
1339|040|H|   It is okay if the tablet sticks to your gum, or to the inside||
1339|041|H|of your lip or cheek. If it does not stick or if it falls off||
1339|042|H|your gum within the first 6 hours, apply it again as directed. If||
1339|043|H|it still does not stick, replace it with a new tablet. If you||
1339|044|H|accidentally swallow the tablet within the first 6 hours after||
1339|045|H|placement, drink a glass of water and apply a new dose to your||
1339|046|H|gum.||
1339|047|H|   If it is 6 hours or longer after placement and the tablet||
1339|048|H|falls off or is accidentally swallowed, do not apply a new dose.||
1339|049|H|Just use your next dose at your usual time.||
1339|050|H|   Avoid activities that may prevent the buccal tablet from||
1339|051|H|sticking to your gum, including touching or pressing the tablet||
1339|052|H|after placement, wearing an upper denture that interferes with||
1339|053|H|tablet placement, chewing gum, hitting the tablet when brushing||
1339|054|H|your teeth, or rinsing your mouth too forcefully.||
1339|055|H|   Antifungals work best when the amount of medicine in your body||
1339|056|H|is kept at a constant level. Use this drug at evenly spaced||
1339|057|H|intervals.||
1339|058|H|   Continue to use this medication until the full prescribed||
1339|059|H|amount is finished, even if symptoms disappear after a few days.||
1339|060|H|Stopping the medication too early may result in a return of the||
1339|061|H|infection.||
1339|062|H|   Tell your doctor if your condition lasts or gets worse.||
1339|063|B|||
1339|064|S|SIDE EFFECTS:  Discomfort, sores, taste changes, or||
1339|065|S|irritation/pain in the mouth may occur. Nausea, vomiting,||
1339|066|S|diarrhea, abdominal pain, or headache may also occur. If any of||
1339|067|S|these effects last or get worse, tell your doctor or pharmacist||
1339|068|S|promptly.||
1339|069|S|   Remember that this medication has been prescribed because your||
1339|070|S|doctor has judged that the benefit to you is greater than the||
1339|071|S|risk of side effects. Many people using this medication do not||
1339|072|S|have serious side effects.||
1339|073|S|   A very serious allergic reaction to this drug is rare.||
1339|074|S|However, get medical help right away if you notice any symptoms||
1339|075|S|of a serious allergic reaction, including: rash, itching/swelling||
1339|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1339|077|S|breathing.||
1339|078|S|   This is not a complete list of possible side effects. If you||
1339|079|S|notice other effects not listed above, contact your doctor or||
1339|080|S|pharmacist.||
1339|081|S|   In the US -||
1339|082|S|   Call your doctor for medical advice about side effects. You||
1339|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1339|084|S|www.fda.gov/medwatch.||
1339|085|S|   In Canada - Call your doctor for medical advice about side||
1339|086|S|effects. You may report side effects to Health Canada at||
1339|087|S|1-866-234-2345.||
1339|088|B|||
1339|089|P|PRECAUTIONS:  Before using miconazole buccal tablets, tell your||
1339|090|P|doctor or pharmacist if you are allergic to miconazole; or if you||
1339|091|P|have any other allergies. This product may contain inactive||
1339|092|P|ingredients (such as milk protein concentrate), which can cause||
1339|093|P|allergic reactions or other problems. Talk to your pharmacist for||
1339|094|P|more details.||
1339|095|P|   Before using this medication, tell your doctor or pharmacist||
1339|096|P|your medical history, especially of: liver problems.||
1339|097|P|   Before having surgery, tell your doctor or dentist about all||
1339|098|P|the products you use (including prescription drugs,||
1339|099|P|nonprescription drugs, and herbal products).||
1339|100|P|   During pregnancy, this medication should be used only when||
1339|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
1339|102|P|   It is unknown if this drug passes into breast milk. Consult||
1339|103|P|your doctor before breastfeeding.||
1339|104|B|||
1339|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1339|106|I|medications work or increase your risk for serious side effects.||
1339|107|I|This document does not contain all possible drug interactions.||
1339|108|I|Keep a list of all the products you use (including||
1339|109|I|prescription/nonprescription drugs and herbal products) and share||
1339|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
1339|111|I|the dosage of any medicines without your doctor's approval.||
1339|112|I|   A product that may interact with this drug is: warfarin.||
1339|113|B|||
1339|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1339|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1339|116|O|poison control center right away. US residents can call||
1339|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1339|118|B|||
1339|119|N|NOTES:  Do not share this medication with others.||
1339|120|N|   This medication has been prescribed for your current condition||
1339|121|N|only. Do not use it later for another infection unless your||
1339|122|N|doctor tells you to.||
1339|123|B|||
1339|124|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1339|125|D|If it is near the time of the next dose, skip the missed dose.||
1339|126|D|Use your next dose at the regular time. Do not double the dose to||
1339|127|D|catch up.||
1339|128|B|||
1339|129|R|STORAGE:  Store at room temperature away from moisture. Do not||
1339|130|R|store in the bathroom. Keep all medications away from children||
1339|131|R|and pets.||
1339|132|R|   Do not flush medications down the toilet or pour them into a||
1339|133|R|drain unless instructed to do so. Properly discard this product||
1339|134|R|when it is expired or no longer needed. Consult your pharmacist||
1339|135|R|or local waste disposal company.||
1339|136|B|||
1339|137|A|Information last revised May 2024.||
1339|138|A|Copyright(c) 2025 First Databank, Inc.||
1339|139|B|||
1341|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1341|002|Z|does NOT have all possible information about this product. This||
1341|003|Z|information does not assure that this product is safe, effective,||
1341|004|Z|or appropriate for you. This information is not individual||
1341|005|Z|medical advice and does not substitute for the advice of your||
1341|006|Z|health care professional. Always ask your health care||
1341|007|Z|professional for complete information about this product and your||
1341|008|Z|specific health needs.||
1341|009|B|||
1341|010|T|BEVACIZUMAB - INJECTION||
1341|011|F|(BE-va-SIZ-oo-mab)||
1341|012|B|||
1341|013|C|COMMON BRAND NAME(S): Alymsys, Avastin, Jobevne, Mvasi, Zirabev||
1341|014|B|||
1341|015|U|USES:  This medication is a man-made antibody (IgG1) used to||
1341|016|U|treat various types of cancer. This drug works by blocking a||
1341|017|U|certain protein (vascular endothelial growth factor-VEGF) thereby||
1341|018|U|decreasing the blood supply to the tumor and slowing tumor||
1341|019|U|growth.||
1341|020|U|   This monograph is about the following bevacizumab products:||
1341|021|U|bevacizumab, bevacizumab-adcd, bevacizumab-awwb,||
1341|022|U|bevacizumab-bvzr, bevacizumab-maly, and bevacizumab-nwgd.||
1341|023|B|||
1341|024|V|OTHER USES:  This section contains uses of this drug that are not||
1341|025|V|listed in the approved professional labeling for the drug but||
1341|026|V|that may be prescribed by your health care professional. Use this||
1341|027|V|drug for a condition that is listed in this section only if it||
1341|028|V|has been so prescribed by your health care professional.||
1341|029|V|   This drug may also be used for certain serious eye conditions||
1341|030|V|(such as age-related macular degeneration, macular edema).||
1341|031|B|||
1341|032|H|HOW TO USE:  This medication is given by infusion into a vein by||
1341|033|H|a health care professional. The first dose is usually given over||
1341|034|H|90 minutes. If you tolerate the first dose well, then later||
1341|035|H|infusions may be given over a shorter time (60 or 30 minutes).||
1341|036|H|   Infusion reactions may happen during the infusion of this||
1341|037|H|drug. Tell your doctor right away if you have any symptoms of||
1341|038|H|infusion reaction such as difficulty breathing, flushing, severe||
1341|039|H|dizziness, nausea/vomiting, shaking, or chest pain. Your doctor||
1341|040|H|may slow down or stop your treatment for some time.||
1341|041|H|   The dosage is based on your medical condition, weight, and||
1341|042|H|response to treatment.||
1341|043|H|   Use this medication regularly to get the most benefit from it.||
1341|044|H|To help you remember, mark your calendar with a reminder.||
1341|045|B|||
1341|046|S|SIDE EFFECTS:  See also How to Use section.||
1341|047|S|   Dry mouth, cough, voice changes, loss of appetite, diarrhea,||
1341|048|S|vomiting, constipation, mouth sores, nausea, or headache may||
1341|049|S|occur. If any of these effects last or get worse, tell your||
1341|050|S|doctor or pharmacist right away.||
1341|051|S|   Remember that this medication has been prescribed because your||
1341|052|S|doctor has judged that the benefit to you is greater than the||
1341|053|S|risk of side effects. Many people using this medication do not||
1341|054|S|have serious side effects.||
1341|055|S|   Tell your doctor right away if you have any serious side||
1341|056|S|effects, including: fast heartbeat, symptoms of heart failure||
1341|057|S|(such as swelling ankles/feet, unusual tiredness, unusual/sudden||
1341|058|S|weight gain), signs of infection (such as sore throat that||
1341|059|S|doesn't go away, fever, chills), muscle cramps, muscle loss,||
1341|060|S|yellowing eyes/skin, dark urine, difficulty urinating, signs of||
1341|061|S|kidney problems (such as change in the amount of urine, frothy||
1341|062|S|urine).||
1341|063|S|   This medication may raise your blood pressure. Check your||
1341|064|S|blood pressure regularly and tell your doctor if the results are||
1341|065|S|high. Your doctor may control your blood pressure with||
1341|066|S|medication.||
1341|067|S|   Bevacizumab may rarely cause serious (sometimes fatal)||
1341|068|S|problems from blood clots (such as heart attack, stroke, blood||
1341|069|S|clots in the lungs or eyes). You may be at increased risk for||
1341|070|S|blood clots if you have a history of blood clots, heart/blood||
1341|071|S|vessel disease, or if you are immobile (such as on very long||
1341|072|S|plane flights or being bedridden). If you use estrogen-containing||
1341|073|S|products, these may also increase your risk. Before using this||
1341|074|S|medication, if you have any of these conditions report them to||
1341|075|S|your doctor or pharmacist. Get medical help right away if any of||
1341|076|S|these side effects occur: shortness of breath/rapid breathing,||
1341|077|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1341|078|S|dizziness/fainting, pain/swelling/warmth in groin/calf,||
1341|079|S|sudden/severe headaches, trouble speaking, weakness on one side||
1341|080|S|of the body, sudden vision changes.||
1341|081|S|   This medication can cause bleeding. Some episodes may be minor||
1341|082|S|including nosebleeds, minor gum bleeding, and vaginal bleeding.||
1341|083|S|If these last or get worse, tell your doctor or pharmacist||
1341|084|S|promptly.||
1341|085|S|   This medication can also cause serious (possibly fatal)||
1341|086|S|bleeding, such as bleeding from the stomach/intestines or in the||
1341|087|S|brain. You should not receive this medication if you have any||
1341|088|S|serious bleeding problems. In addition, this medication can||
1341|089|S|rarely cause a tear in the stomach/intestines (gastrointestinal||
1341|090|S|perforation). Get medical help right away if you have any signs||
1341|091|S|of these serious side effects, including stomach/abdominal pain||
1341|092|S|that is severe or doesn't go away, bloody or black/tarry stools,||
1341|093|S|constipation with vomiting, vomit that is bloody or looks like||
1341|094|S|coffee grounds, coughing up blood, shortness of breath,||
1341|095|S|dizziness/fainting, unusual tiredness/weakness, severe headache,||
1341|096|S|sudden/severe back pain, fever.||
1341|097|S|   This medication may also cause wounds to heal slowly or poorly||
1341|098|S|or cause the wounds to break open. It can also rarely cause very||
1341|099|S|serious (possibly fatal) skin and tissue infections that spread||
1341|100|S|quickly. Get medical help right away if you have wounds that are||
1341|101|S|not healing well, a fever, severe pain/redness/heat/swelling at||
1341|102|S|the surgery site or other areas on the skin, fluid-filled||
1341|103|S|blisters in the skin, discolored/scaling/peeling skin, confusion,||
1341|104|S|dizziness, or fainting. You should not receive this medication||
1341|105|S|for at least 4 weeks before and after a major surgery and until||
1341|106|S|the wound from the surgery is fully healed.||
1341|107|S|   Rarely, bevacizumab may cause a condition called PRES||
1341|108|S|(posterior reversible encephalopathy syndrome). Get medical help||
1341|109|S|right away if you develop headache that doesn't go away,||
1341|110|S|seizures, sudden vision changes, mental/mood changes (such as||
1341|111|S|confusion).||
1341|112|S|   A very serious allergic reaction to this drug is rare.||
1341|113|S|However, get medical help right away if you notice any symptoms||
1341|114|S|of a serious allergic reaction, including: rash, itching/swelling||
1341|115|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1341|116|S|breathing.||
1341|117|S|   This is not a complete list of possible side effects. If you||
1341|118|S|notice other effects not listed above, contact your doctor or||
1341|119|S|pharmacist.||
1341|120|S|   In the US -||
1341|121|S|   Call your doctor for medical advice about side effects. You||
1341|122|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1341|123|S|www.fda.gov/medwatch.||
1341|124|S|   In Canada - Call your doctor for medical advice about side||
1341|125|S|effects. You may report side effects to Health Canada at||
1341|126|S|1-866-234-2345.||
1341|127|B|||
1341|128|P|PRECAUTIONS:  See also Side Effects section.||
1341|129|P|   Before using bevacizumab, tell your doctor or pharmacist if||
1341|130|P|you are allergic to it; or to any bevacizumab products; or if you||
1341|131|P|have any other allergies. This product may contain inactive||
1341|132|P|ingredients, which can cause allergic reactions or other||
1341|133|P|problems. Talk to your pharmacist for more details.||
1341|134|P|   Before using this medication, tell your doctor or pharmacist||
1341|135|P|your medical history, especially of: stomach/intestinal ulcers,||
1341|136|P|bleeding problems (such as recent bloody vomiting or coughing up||
1341|137|P|blood), recent major surgery, recent injuries/wounds, high blood||
1341|138|P|pressure, blood vessel problems (such as an aneurysm or a||
1341|139|P|tear/break in the aorta or other blood vessels), kidney disease,||
1341|140|P|diabetes.||
1341|141|P|   Before having surgery or any medical procedure, tell your||
1341|142|P|doctor or dentist about all the products you use (including||
1341|143|P|prescription drugs, nonprescription drugs, and herbal products).||
1341|144|P|   Bevacizumab can make you more likely to get infections or may||
1341|145|P|make current infections worse. Stay away from anyone who has an||
1341|146|P|infection that may easily spread (such as chickenpox, COVID-19,||
1341|147|P|measles, flu). Talk to your doctor if you have been exposed to an||
1341|148|P|infection or for more details.||
1341|149|P|   Tell your health care professional that you are using||
1341|150|P|bevacizumab before having any immunizations/vaccinations. Avoid||
1341|151|P|contact with people who have recently received live vaccines||
1341|152|P|(such as flu vaccine inhaled through the nose).||
1341|153|P|   To lower the chance of getting cut, bruised, or injured, use||
1341|154|P|caution with sharp objects like razors and nail cutters, and||
1341|155|P|avoid activities such as contact sports.||
1341|156|P|   Older adults may be at greater risk for side effects (such as||
1341|157|P|blood clots, kidney effects such as protein in the urine). See||
1341|158|P|also Side Effects section.||
1341|159|P|   This medication can affect fertility in females. Ask your||
1341|160|P|doctor for more details.||
1341|161|P|   During pregnancy, this medication should be used only when||
1341|162|P|clearly needed. It may harm an unborn baby. Ask about reliable||
1341|163|P|forms of birth control while using this medication and for 6||
1341|164|P|months after the last dose. Discuss the risks and benefits with||
1341|165|P|your doctor.||
1341|166|P|   This medication may pass into breast milk. Because of the||
1341|167|P|possible risk to the infant, breastfeeding is not recommended||
1341|168|P|while using this medication and for 6 months after the last dose.||
1341|169|P|Consult your doctor before breastfeeding.||
1341|170|B|||
1341|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1341|172|I|medications work or increase your risk for serious side effects.||
1341|173|I|This document does not contain all possible drug interactions.||
1341|174|I|Keep a list of all the products you use (including||
1341|175|I|prescription/nonprescription drugs and herbal products) and share||
1341|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
1341|177|I|the dosage of any medicines without your doctor's approval.||
1341|178|I|   A product that may interact with this drug is: sunitinib.||
1341|179|B|||
1341|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1341|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1341|182|O|poison control center right away. US residents can call||
1341|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1341|184|O|Symptoms of overdose may include: severe headache.||
1341|185|B|||
1341|186|N|NOTES:  Lab and/or medical tests (such as blood pressure||
1341|187|N|monitoring, urine tests for protein, kidney function, bilirubin||
1341|188|N|levels, complete blood counts-CBC) should be done while you are||
1341|189|N|using this medication. Keep all medical and lab appointments.||
1341|190|N|Consult your doctor for more details.||
1341|191|B|||
1341|192|D|MISSED DOSE:  It is important to get each dose of this medication||
1341|193|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1341|194|D|right away for a new dosing schedule.||
1341|195|B|||
1341|196|R|STORAGE:  Not applicable. This medication is given in a clinic||
1341|197|R|and will not be stored at home.||
1341|198|B|||
1341|199|M|MEDICAL ALERT:  Your condition can cause complications in a||
1341|200|M|medical emergency. For information about enrolling in MedicAlert,||
1341|201|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1341|202|B|||
1341|203|A|Information last revised August 2025.||
1341|204|A|Copyright(c) 2025 First Databank, Inc.||
1341|205|B|||
1342|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1342|002|Z|does NOT have all possible information about this product. This||
1342|003|Z|information does not assure that this product is safe, effective,||
1342|004|Z|or appropriate for you. This information is not individual||
1342|005|Z|medical advice and does not substitute for the advice of your||
1342|006|Z|health care professional. Always ask your health care||
1342|007|Z|professional for complete information about this product and your||
1342|008|Z|specific health needs.||
1342|009|B|||
1342|010|T|ESTRADIOL VALERATE/DIENOGEST - ESTRADIOL VALERATE - ORAL||
1342|011|F|(ES-tra-DYE-ol VAL-er-ate/dye-EN-oh-jest-ES-tra-DYE-ol VAL-er-ate)||
1342|012|B|||
1342|013|C|COMMON BRAND NAME(S): Natazia||
1342|014|B|||
1342|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
1342|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
1342|017|W|stroke, heart attack, blood clots, and high blood pressure from||
1342|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
1342|019|W|of these serious problems increases with age and with the number||
1342|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
1342|021|B|||
1342|022|U|USES:  This combination hormone medication is used to prevent||
1342|023|U|pregnancy. It contains 2 hormones: dienogest (a progestin) and||
1342|024|U|estradiol valerate (an estrogen).||
1342|025|U|   Besides preventing pregnancy, birth control pills may make||
1342|026|U|your periods more regular, decrease blood loss and painful||
1342|027|U|periods, decrease your risk of ovarian cysts, and also treat||
1342|028|U|acne.||
1342|029|U|   This medication does not protect against sexually transmitted||
1342|030|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1342|031|U|an effective barrier method (latex or polyurethane condom/dental||
1342|032|U|dams) during sexual activity will help to decrease your risk of||
1342|033|U|infection.||
1342|034|B|||
1342|035|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1342|036|H|your pharmacist before you start taking this medication and each||
1342|037|H|time you get a refill. The leaflet contains very important||
1342|038|H|information on when to take your pills and what to do if you miss||
1342|039|H|a dose. If you have any questions, ask your doctor or pharmacist.||
1342|040|H|   Take this medication by mouth as directed by your doctor,||
1342|041|H|usually once daily. Pick a time of day that is easy for you to||
1342|042|H|remember, and take your pill at the same time each day.||
1342|043|H|   It is very important to keep taking this medication exactly as||
1342|044|H|prescribed by your doctor. With certain brands of birth control||
1342|045|H|pills, the amount of estrogen and progestin in each active tablet||
1342|046|H|will vary at different times in the cycle. Follow the package||
1342|047|H|instructions to find the first tablet, start with the first||
1342|048|H|tablet in the pack, and take them in the correct order. Do not||
1342|049|H|skip any doses. Pregnancy is more likely if you miss pills, start||
1342|050|H|a new pack late, or take your pill 12 hours later than the usual||
1342|051|H|time.||
1342|052|H|   If you have vomiting or diarrhea within 3 to 4 hours after||
1342|053|H|taking your tablet, read the Patient Information Leaflet section||
1342|054|H|titled "What to Do if You Miss Tablets." Follow the instructions||
1342|055|H|as if you had missed your dose because vomiting/diarrhea can stop||
1342|056|H|the tablet from working.||
1342|057|H|   Taking this medication after your evening meal or at bedtime||
1342|058|H|may help if you have stomach upset or nausea with the medication.||
1342|059|H|You may choose to take this medication at another time of day||
1342|060|H|that is easier for you to remember. No matter what dosing||
1342|061|H|schedule you use, it is very important that you take this||
1342|062|H|medication at the same time each day, 24 hours apart.||
1342|063|H|   Your pill pack contains 26 pills with active medication. It||
1342|064|H|also contains 2 reminder pills with no medication. Take one||
1342|065|H|active pill (with hormones) once daily for 26 days in a row.||
1342|066|H|After you have taken the last active pill, take one reminder pill||
1342|067|H|once daily for 2 days in a row unless otherwise directed by your||
1342|068|H|doctor. You should have your period during the fourth week of the||
1342|069|H|cycle. After you have taken the last reminder tablet in the pack,||
1342|070|H|start a new pack the next day even if your period is continuing||
1342|071|H|or if you do not have your period. If you do not get your period,||
1342|072|H|consult your doctor.||
1342|073|H|   If this is the first time you are using this medication and||
1342|074|H|you are not switching from another form of hormonal birth control||
1342|075|H|(such as patch, other birth control pills), take the first tablet||
1342|076|H|in the pack on the first day of your period. For the first cycle||
1342|077|H|of use only, use an additional form of non-hormonal birth control||
1342|078|H|(such as condoms, spermicide) for the first 9 days to prevent||
1342|079|H|pregnancy until the medication has enough time to work.||
1342|080|H|   Ask your doctor or pharmacist for information about how to||
1342|081|H|switch from other forms of hormonal birth control (such as patch,||
1342|082|H|other birth control pills) to this product. If any information is||
1342|083|H|unclear, consult the Patient Information Leaflet or your doctor||
1342|084|H|or pharmacist.||
1342|085|B|||
1342|086|S|SIDE EFFECTS:  Nausea, vomiting, headache, abdominal||
1342|087|S|cramps/bloating, breast tenderness, swelling of the ankles/feet||
1342|088|S|(retaining fluid), or weight change may occur. Vaginal bleeding||
1342|089|S|between periods (spotting) or missed/irregular periods may occur,||
1342|090|S|especially during the first few months of use. If any of these||
1342|091|S|effects last or get worse, tell your doctor or pharmacist||
1342|092|S|promptly. If you miss 2 periods in a row (or 1 period if the pill||
1342|093|S|has not been used properly), contact your doctor for a pregnancy||
1342|094|S|test.||
1342|095|S|   Remember that this medication has been prescribed because your||
1342|096|S|doctor has judged that the benefit to you is greater than the||
1342|097|S|risk of side effects. Many people using this medication do not||
1342|098|S|have serious side effects.||
1342|099|S|   This medication may raise your blood pressure. Check your||
1342|100|S|blood pressure regularly and tell your doctor if the results are||
1342|101|S|high.||
1342|102|S|   Tell your doctor right away if you have any serious side||
1342|103|S|effects, including: a lump in your breast, unusual changes in||
1342|104|S|vaginal bleeding (such as continuous spotting, sudden heavy||
1342|105|S|bleeding), mental/mood changes (such as new/worsening||
1342|106|S|depression), dark urine, yellowing eyes/skin, severe||
1342|107|S|stomach/abdominal/pelvic pain, unusual tiredness.||
1342|108|S|   This medication may rarely cause serious (sometimes fatal)||
1342|109|S|problems from blood clots (such as heart attack, stroke, blood||
1342|110|S|clots in the lungs or legs). Get medical help right away if you||
1342|111|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1342|112|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
1342|113|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1342|114|S|trouble speaking, weakness on one side of the body, sudden vision||
1342|115|S|changes.||
1342|116|S|   A very serious allergic reaction to this drug is rare.||
1342|117|S|However, get medical help right away if you notice any symptoms||
1342|118|S|of a serious allergic reaction, including: rash, itching/swelling||
1342|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1342|120|S|breathing.||
1342|121|S|   This is not a complete list of possible side effects. If you||
1342|122|S|notice other effects not listed above, contact your doctor or||
1342|123|S|pharmacist.||
1342|124|S|   In the US -||
1342|125|S|   Call your doctor for medical advice about side effects. You||
1342|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1342|127|S|www.fda.gov/medwatch.||
1342|128|S|   In Canada - Call your doctor for medical advice about side||
1342|129|S|effects. You may report side effects to Health Canada at||
1342|130|S|1-866-234-2345.||
1342|131|B|||
1342|132|P|PRECAUTIONS:  See also Warning section.||
1342|133|P|   Before using this medication, tell your doctor or pharmacist||
1342|134|P|if you are allergic to estradiol or dienogest; or to any||
1342|135|P|estrogens (such as mestranol) or any progestins (such as||
1342|136|P|norethindrone, desogestrel); or if you have any other allergies.||
1342|137|P|This product may contain inactive ingredients, which can cause||
1342|138|P|allergic reactions or other problems. Talk to your pharmacist for||
1342|139|P|more details.||
1342|140|P|   Before using this product, tell your doctor or pharmacist your||
1342|141|P|medical history, especially of: blood clots (for example, in the||
1342|142|P|legs, eyes, lungs), blood clotting disorders (such as protein C||
1342|143|P|or protein S deficiency), high blood pressure, abnormal breast||
1342|144|P|exam, cancer (especially endometrial or breast cancer), high||
1342|145|P|cholesterol or triglyceride (blood fat) levels, depression,||
1342|146|P|diabetes, family or personal history of a certain swelling||
1342|147|P|disorder (angioedema), gallbladder problems, severe||
1342|148|P|headaches/migraine, heart problems (such as heart valve disease,||
1342|149|P|irregular heartbeat, previous heart attack), history of yellowing||
1342|150|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
1342|151|P|birth control (such as pills, patch), kidney disease, liver||
1342|152|P|disease (including tumors), obesity, stroke, swelling (edema),||
1342|153|P|thyroid problems, unexplained vaginal bleeding.||
1342|154|P|   If you have diabetes, this medication may affect your blood||
1342|155|P|sugar. Check your blood sugar regularly as directed and share the||
1342|156|P|results with your doctor. Tell your doctor right away if you have||
1342|157|P|symptoms of high blood sugar such as increased thirst/urination.||
1342|158|P|Your doctor may need to adjust your diabetes medication, exercise||
1342|159|P|program, or diet.||
1342|160|P|   Tell your doctor if you just had or will be having surgery or||
1342|161|P|if you will be confined to a bed or chair for a long time (such||
1342|162|P|as on a long plane flight). These conditions increase your risk||
1342|163|P|of getting blood clots, especially if you are using hormonal||
1342|164|P|birth control. You may need to stop this medication for a time or||
1342|165|P|take special precautions.||
1342|166|P|   Before having surgery, tell your doctor or dentist about all||
1342|167|P|the products you use (including prescription drugs,||
1342|168|P|nonprescription drugs, and herbal products).||
1342|169|P|   This medication may cause blotchy, dark areas on your face and||
1342|170|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
1342|171|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
1342|172|P|wear protective clothing when outdoors.||
1342|173|P|   If you are nearsighted or wear contact lenses, you may develop||
1342|174|P|vision problems or trouble wearing your contact lenses. Contact||
1342|175|P|your eye doctor if these problems occur.||
1342|176|P|   It may take longer for you to become pregnant after you stop||
1342|177|P|taking birth control pills. Consult your doctor.||
1342|178|P|   This medication should not be used during pregnancy. If you||
1342|179|P|become pregnant or think you may be pregnant, tell your doctor||
1342|180|P|right away. If you have just given birth or had a pregnancy||
1342|181|P|loss/abortion after the first 3 months, talk with your doctor||
1342|182|P|about reliable forms of birth control, and find out when it is||
1342|183|P|safe to start using birth control that contains a form of||
1342|184|P|estrogen, such as this medication.||
1342|185|P|   A small amount of this medication passes into breast milk and||
1342|186|P|may have undesirable effects on a nursing infant. Consult your||
1342|187|P|doctor before breastfeeding.||
1342|188|B|||
1342|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1342|190|I|medications work or increase your risk for serious side effects.||
1342|191|I|This document does not contain all possible drug interactions.||
1342|192|I|Keep a list of all the products you use (including||
1342|193|I|prescription/nonprescription drugs and herbal products) and share||
1342|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
1342|195|I|the dosage of any medicines without your doctor's approval.||
1342|196|I|   Some products that may interact with this drug include:||
1342|197|I|aromatase inhibitors (such as anastrozole, exemestane,||
1342|198|I|letrozole), fezolinetant, ospemifene, tamoxifen, tranexamic acid.||
1342|199|I|   Some drugs may cause hormonal birth control to work less well||
1342|200|I|by decreasing the amount of birth control hormones in your body.||
1342|201|I|This effect can result in pregnancy. Examples include||
1342|202|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
1342|203|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
1342|204|I|seizures (such as barbiturates, carbamazepine, felbamate,||
1342|205|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
1342|206|I|nevirapine), among others.||
1342|207|I|   Tell your doctor when you start any new drug, and discuss if||
1342|208|I|you should use reliable backup birth control. Also tell your||
1342|209|I|doctor if you have any new spotting or breakthrough bleeding,||
1342|210|I|because these may be signs that your birth control is not working||
1342|211|I|well.||
1342|212|I|   This medication may interfere with certain lab tests (such as||
1342|213|I|blood tests for clotting factors, thyroid), possibly causing||
1342|214|I|false test results. Make sure lab personnel and all your doctors||
1342|215|I|know you use this drug.||
1342|216|B|||
1342|217|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1342|218|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1342|219|O|poison control center right away. US residents can call||
1342|220|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1342|221|O|Symptoms of overdose may include: severe nausea and vomiting,||
1342|222|O|sudden/unusual vaginal bleeding.||
1342|223|B|||
1342|224|N|NOTES:  Do not share this medication with others.||
1342|225|N|   Regular complete physical exams which include lab and/or||
1342|226|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
1342|227|N|Pap smear) should be done while you are taking this medication.||
1342|228|N|Follow your doctor's instructions for examining your breasts, and||
1342|229|N|report any lumps right away. Keep all medical and lab||
1342|230|N|appointments. Consult your doctor for more details.||
1342|231|B|||
1342|232|D|MISSED DOSE:  Missed dose advice is different depending on the||
1342|233|D|brand used and the number of doses missed. Refer to the product||
1342|234|D|package information for advice on missed doses. You may need to||
1342|235|D|use backup birth control (such as condoms, spermicide) to prevent||
1342|236|D|pregnancy. Ask your doctor or pharmacist if you have any||
1342|237|D|questions.||
1342|238|D|   If you often forget to take your pills as directed, contact||
1342|239|D|your doctor to discuss switching to another form of birth||
1342|240|D|control.||
1342|241|B|||
1342|242|R|STORAGE:  Store at room temperature away from light and moisture.||
1342|243|R|Do not store in the bathroom. Keep all medications away from||
1342|244|R|children and pets.||
1342|245|R|   Do not flush medications down the toilet or pour them into a||
1342|246|R|drain unless instructed to do so. Properly discard this product||
1342|247|R|when it is expired or no longer needed. Consult your pharmacist||
1342|248|R|or local waste disposal company.||
1342|249|B|||
1342|250|A|Information last revised October 2025.||
1342|251|A|Copyright(c) 2025 First Databank, Inc.||
1342|252|B|||
1343|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1343|002|Z|does NOT have all possible information about this product. This||
1343|003|Z|information does not assure that this product is safe, effective,||
1343|004|Z|or appropriate for you. This information is not individual||
1343|005|Z|medical advice and does not substitute for the advice of your||
1343|006|Z|health care professional. Always ask your health care||
1343|007|Z|professional for complete information about this product and your||
1343|008|Z|specific health needs.||
1343|009|B|||
1343|010|T|MOMETASONE/FORMOTEROL INHALER - ORAL INHALATION||
1343|011|F|(moe-MET-a-sone/for-MOE-ter-ol)||
1343|012|B|||
1343|013|C|COMMON BRAND NAME(S): Dulera||
1343|014|B|||
1343|015|U|USES:  This product is used to control and prevent symptoms||
1343|016|U|(wheezing and shortness of breath) caused by asthma. It contains||
1343|017|U|2 medications: mometasone and formoterol. Mometasone belongs to a||
1343|018|U|class of drugs known as corticosteroids. It works by reducing the||
1343|019|U|irritation and swelling of the airways. Formoterol belongs to the||
1343|020|U|class of drugs known as long-acting beta agonists. It works by||
1343|021|U|relaxing the muscles around the airways so that they open up and||
1343|022|U|you can breathe more easily. Controlling symptoms of breathing||
1343|023|U|problems can decrease time lost from work or school.||
1343|024|U|   When used alone, long-acting beta agonists (such as||
1343|025|U|formoterol) may rarely increase the risk of serious (sometimes||
1343|026|U|fatal) asthma-related breathing problems. However, combination||
1343|027|U|inhaled corticosteroid and long-acting beta agonists, such as||
1343|028|U|this product, do not increase the risk of serious asthma-related||
1343|029|U|breathing problems.||
1343|030|U|   Before using this medication, it is important to learn how to||
1343|031|U|use it properly. If an asthma attack occurs, use your||
1343|032|U|quick-relief inhaler (such as albuterol, also called salbutamol||
1343|033|U|in some countries) as prescribed. See also How to Use section.||
1343|034|B|||
1343|035|V|OTHER USES:  This section contains uses of this drug that are not||
1343|036|V|listed in the approved professional labeling for the drug but||
1343|037|V|that may be prescribed by your health care professional. Use this||
1343|038|V|drug for a condition that is listed in this section only if it||
1343|039|V|has been so prescribed by your health care professional.||
1343|040|V|   This product may also be used to control symptoms (such as||
1343|041|V|wheezing and shortness of breath) caused by ongoing lung disease||
1343|042|V|(chronic obstructive pulmonary disease-COPD, which includes||
1343|043|V|chronic bronchitis and emphysema). This product may also be used||
1343|044|V|for sudden breathing problems caused by asthma (asthma attack).||
1343|045|B|||
1343|046|H|HOW TO USE:  Read the Patient Information Leaflet and||
1343|047|H|Instructions for Use provided by your pharmacist before you start||
1343|048|H|using this medication and each time you get a refill. Follow the||
1343|049|H|illustrated directions for the proper use of this medication. If||
1343|050|H|you have any questions, ask your doctor or pharmacist.||
1343|051|H|   Follow the instructions for priming the inhaler if you are||
1343|052|H|using it for the first time or if you have not used it for more||
1343|053|H|than 5 days. Do not spray the medication into your eyes.||
1343|054|H|   Shake the inhaler well before each use. Remove the cap. Inhale||
1343|055|H|this medication by mouth as directed by your doctor, usually||
1343|056|H|twice daily (in the morning and evening). Always replace the cap||
1343|057|H|properly after using the inhaler.||
1343|058|H|   If your prescribed dose is 2 puffs, wait at least one minute||
1343|059|H|between them. If you are using other inhalers at the same time,||
1343|060|H|wait at least 1 minute between the use of each medication, and||
1343|061|H|use this drug last.||
1343|062|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
1343|063|H|from developing, gargle, rinse your mouth with water and spit out||
1343|064|H|after each use. Do not swallow the rinse water.||
1343|065|H|   To clean your inhaler, wipe the outside of the mouthpiece once||
1343|066|H|a week with a dry tissue. Do not use water or other liquids. Do||
1343|067|H|not take the inhaler apart.||
1343|068|H|   Use this medication regularly in order to get the most benefit||
1343|069|H|from it. This medication works best if used at evenly spaced||
1343|070|H|times. To help you remember, use it at the same times each day.||
1343|071|H|Do not increase your dose, use this medication more often, or||
1343|072|H|stop using it without first consulting your doctor. Also, do not||
1343|073|H|use other long-acting beta agonists while using this medication.||
1343|074|H|   If you are regularly taking a different corticosteroid by||
1343|075|H|mouth (such as prednisone), you should not stop taking it unless||
1343|076|H|directed by your doctor. Some conditions (such as asthma,||
1343|077|H|allergies) may become worse when the drug is suddenly stopped. If||
1343|078|H|you suddenly stop taking the drug, you may also have withdrawal||
1343|079|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
1343|080|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
1343|081|H|doctor may slowly lower the dose of your old medication after you||
1343|082|H|begin using mometasone/formoterol. Tell your doctor or pharmacist||
1343|083|H|right away if you have withdrawal. See also Precautions section.||
1343|084|H|   If you have been using a quick-relief inhaler (such as||
1343|085|H|albuterol, also called salbutamol in some countries) on a regular||
1343|086|H|daily schedule (such as 4 times daily), you must stop this||
1343|087|H|schedule and only use the quick-relief inhaler as needed for||
1343|088|H|sudden shortness of breath/asthma attacks. Consult your doctor||
1343|089|H|for details.||
1343|090|H|   It may take 1 week or longer before you get the full benefit||
1343|091|H|of this drug. Tell your doctor if your symptoms do not get better||
1343|092|H|or if they get worse.||
1343|093|H|   Learn which of your inhalers you should use every day||
1343|094|H|(controller drugs) and which you should use if your breathing||
1343|095|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
1343|096|H|time what you should do if you have new or worsening cough or||
1343|097|H|shortness of breath, wheezing, increased sputum, worsening peak||
1343|098|H|flow meter readings, waking up at night with trouble breathing,||
1343|099|H|if you use your quick-relief inhaler more often (more than 2 days||
1343|100|H|a week), or if your quick-relief inhaler does not seem to be||
1343|101|H|working well. Learn when you can treat sudden breathing problems||
1343|102|H|by yourself and when you must get medical help right away.||
1343|103|B|||
1343|104|S|SIDE EFFECTS:  Stuffy nose, hoarseness, dry mouth, or throat||
1343|105|S|irritation may occur. If any of these effects last or get worse,||
1343|106|S|tell your doctor promptly.||
1343|107|S|   Remember that this medication has been prescribed because your||
1343|108|S|doctor has judged that the benefit to you is greater than the||
1343|109|S|risk of side effects. Many people using this medication do not||
1343|110|S|have serious side effects.||
1343|111|S|   This medication may raise your blood pressure. Check your||
1343|112|S|blood pressure regularly and tell your doctor if the results are||
1343|113|S|high.||
1343|114|S|   Rarely, this medication may cause severe sudden worsening of||
1343|115|S|breathing problems/asthma immediately after use. If you have||
1343|116|S|sudden worsening of breathing, use your quick-relief inhaler and||
1343|117|S|get medical help right away.||
1343|118|S|   Tell your doctor right away if you have any serious side||
1343|119|S|effects, including: white patches on tongue/in mouth, signs of||
1343|120|S|infection (such as sore throat that doesn't go away, fever,||
1343|121|S|chills), mental/mood changes (such as nervousness), trouble||
1343|122|S|sleeping, vision problems (such as blurred vision), increased||
1343|123|S|thirst/urination, muscle cramps, shaking (tremors).||
1343|124|S|   Get medical help right away if you have any very serious side||
1343|125|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1343|126|S|dizziness, fainting, seizures.||
1343|127|S|   A very serious allergic reaction to this product is rare.||
1343|128|S|However, get medical help right away if you notice any symptoms||
1343|129|S|of a serious allergic reaction, including: rash, itching/swelling||
1343|130|S|(especially of the face/tongue/throat), severe dizziness, sudden||
1343|131|S|trouble breathing.||
1343|132|S|   This is not a complete list of possible side effects. If you||
1343|133|S|notice other effects not listed above, contact your doctor or||
1343|134|S|pharmacist.||
1343|135|S|   In the US -||
1343|136|S|   Call your doctor for medical advice about side effects. You||
1343|137|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1343|138|S|www.fda.gov/medwatch.||
1343|139|S|   In Canada - Call your doctor for medical advice about side||
1343|140|S|effects. You may report side effects to Health Canada at||
1343|141|S|1-866-234-2345.||
1343|142|B|||
1343|143|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1343|144|P|pharmacist if you are allergic to mometasone or formoterol; or to||
1343|145|P|arformoterol; or if you have any other allergies. This product||
1343|146|P|may contain inactive ingredients, which can cause allergic||
1343|147|P|reactions or other problems. Talk to your pharmacist for more||
1343|148|P|details.||
1343|149|P|   Before using this medication, tell your doctor or pharmacist||
1343|150|P|your medical history, especially of: current/past infections||
1343|151|P|(such as tuberculosis, herpes), high blood pressure, heart||
1343|152|P|disease (such as chest pain, heart attack, irregular heartbeat),||
1343|153|P|overactive thyroid (hyperthyroidism), seizures, bone loss||
1343|154|P|(osteoporosis), eye problems (such as cataracts, glaucoma),||
1343|155|P|diabetes, swelling of an artery (aneurysm), a certain adrenal||
1343|156|P|gland tumor (pheochromocytoma).||
1343|157|P|   Formoterol may cause a condition that affects the heart rhythm||
1343|158|P|(QT prolongation). QT prolongation can rarely cause serious||
1343|159|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1343|160|P|as severe dizziness, fainting) that need medical attention right||
1343|161|P|away.||
1343|162|P|   The risk of QT prolongation may be increased if you have||
1343|163|P|certain medical conditions or are taking other drugs that may||
1343|164|P|cause QT prolongation. Before using this product, tell your||
1343|165|P|doctor or pharmacist of all the drugs you take and if you have||
1343|166|P|any of the following conditions: certain heart problems (heart||
1343|167|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1343|168|P|history of certain heart problems (QT prolongation in the EKG,||
1343|169|P|sudden cardiac death).||
1343|170|P|   Low levels of potassium or magnesium in the blood may also||
1343|171|P|increase your risk of QT prolongation. This risk may increase if||
1343|172|P|you use certain drugs (such as diuretics/"water pills") or if you||
1343|173|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1343|174|P|Talk to your doctor about using this medication safely.||
1343|175|P|   This medication may mask signs of infection. It can make you||
1343|176|P|more likely to get infections or may make current infections||
1343|177|P|worse. Stay away from anyone who has an infection that may easily||
1343|178|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1343|179|P|doctor if you have been exposed to an infection or for more||
1343|180|P|details.||
1343|181|P|   If you have switched from a corticosteroid taken by mouth||
1343|182|P|(such as prednisone tablets) to this inhaler within the past 12||
1343|183|P|months, or if you have been using this product in||
1343|184|P|higher-than-usual doses for a long time, it may be more difficult||
1343|185|P|for your body to respond to physical stress. Before having||
1343|186|P|surgery or emergency treatment, or if you get a serious||
1343|187|P|illness/injury, tell your doctor or dentist that you are using||
1343|188|P|this medication or have used a corticosteroid taken by mouth||
1343|189|P|within the past 12 months. Tell your doctor right away if you||
1343|190|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
1343|191|P|card or medical ID bracelet that says you use (or have used)||
1343|192|P|corticosteroid medications.||
1343|193|P|   Before having surgery, tell your doctor or dentist about all||
1343|194|P|the products you use (including prescription drugs,||
1343|195|P|nonprescription drugs, and herbal products).||
1343|196|P|   This medication may temporarily slow down a child's growth if||
1343|197|P|used for a long time. However, poorly controlled asthma can also||
1343|198|P|slow down growth. See the doctor regularly so your child's height||
1343|199|P|can be checked.||
1343|200|P|   Older adults may be more sensitive to the side effects of this||
1343|201|P|drug, especially QT prolongation (see above).||
1343|202|P|   During pregnancy, this medication should be used only when||
1343|203|P|clearly needed. Discuss the risks and benefits with your doctor.||
1343|204|P|   It is unknown if this medication passes into breast milk.||
1343|205|P|Consult your doctor before breastfeeding.||
1343|206|B|||
1343|207|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1343|208|I|medications work or increase your risk for serious side effects.||
1343|209|I|This document does not contain all possible drug interactions.||
1343|210|I|Keep a list of all the products you use (including||
1343|211|I|prescription/nonprescription drugs and herbal products) and share||
1343|212|I|it with your doctor and pharmacist. Do not start, stop, or change||
1343|213|I|the dosage of any medicines without your doctor's approval.||
1343|214|I|   A product that may interact with this drug is: desmopressin.||
1343|215|B|||
1343|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1343|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1343|218|O|poison control center right away. US residents can call||
1343|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1343|220|O|Symptoms of overdose may include: shaking (tremors), chest pain,||
1343|221|O|fast/irregular heartbeat.||
1343|222|B|||
1343|223|N|NOTES:  Do not share this medication with others.||
1343|224|N|   Lab and/or medical tests (such as lung function, blood||
1343|225|N|pressure, bone density tests, eye exam) may be done while you are||
1343|226|N|using this medication. Keep all medical and lab appointments.||
1343|227|N|Consult your doctor for more details.||
1343|228|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
1343|229|N|mold that can worsen breathing problems. Because the flu virus||
1343|230|N|can also worsen breathing problems, ask your doctor or pharmacist||
1343|231|N|if you should have a flu shot every year.||
1343|232|N|   This medication may cause bone loss (osteoporosis) in adults||
1343|233|N|when used for a long time. Lifestyle changes that may help reduce||
1343|234|N|the risk of bone problems include doing weight-bearing exercise,||
1343|235|N|stopping smoking, limiting alcohol, and getting enough calcium||
1343|236|N|and vitamin D. Talk to your doctor for more details.||
1343|237|B|||
1343|238|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1343|239|D|next dose at the regular time. Do not double the dose to catch||
1343|240|D|up.||
1343|241|B|||
1343|242|R|STORAGE:  Store at room temperature away from heat. Do not store||
1343|243|R|or use near an open flame. Keep all medications away from||
1343|244|R|children and pets.||
1343|245|R|   Do not flush medications down the toilet or pour them into a||
1343|246|R|drain unless instructed to do so. Properly discard this product||
1343|247|R|when it is expired or no longer needed. Consult your pharmacist||
1343|248|R|or local waste disposal company.||
1343|249|B|||
1343|250|M|MEDICAL ALERT:  Your condition can cause complications in a||
1343|251|M|medical emergency. For information about enrolling in MedicAlert,||
1343|252|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1343|253|B|||
1343|254|A|Information last revised September 2025.||
1343|255|A|Copyright(c) 2025 First Databank, Inc.||
1343|256|B|||
1344|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1344|002|Z|does NOT have all possible information about this product. This||
1344|003|Z|information does not assure that this product is safe, effective,||
1344|004|Z|or appropriate for you. This information is not individual||
1344|005|Z|medical advice and does not substitute for the advice of your||
1344|006|Z|health care professional. Always ask your health care||
1344|007|Z|professional for complete information about this product and your||
1344|008|Z|specific health needs.||
1344|009|B|||
1344|010|T|BUPRENORPHINE - TRANSDERMAL||
1344|011|F|(BUE-pre-NOR-feen)||
1344|012|B|||
1344|013|C|COMMON BRAND NAME(S): Butrans||
1344|014|B|||
1344|015|W|WARNING:  Buprenorphine has a risk for abuse and addiction, which||
1344|016|W|can lead to overdose and death. Buprenorphine may also cause||
1344|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
1344|018|W|your doctor should have you use the smallest dose of||
1344|019|W|buprenorphine that works, and use it for the shortest possible||
1344|020|W|time. See also How to Use section for more information about||
1344|021|W|addiction.||
1344|022|W|   Ask your doctor or pharmacist if you should have medication||
1344|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1344|024|W|Teach your family or household members about the signs of an||
1344|025|W|opioid overdose and how to treat it.||
1344|026|W|   The risk for severe breathing problems is higher when you||
1344|027|W|start this medication and after a dose increase, or if you use||
1344|028|W|the wrong dose/strength or misuse the medication (such as chewing||
1344|029|W|or swallowing the patch). Using this medication with alcohol or||
1344|030|W|other drugs that can cause drowsiness or breathing problems may||
1344|031|W|cause very serious side effects, including death. Be sure you||
1344|032|W|know how to use buprenorphine and what other drugs you should||
1344|033|W|avoid taking with it. See also Drug Interactions section. Get||
1344|034|W|medical help right away if any of these very serious side effects||
1344|035|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
1344|036|W|drowsiness/dizziness, difficulty waking up.||
1344|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1344|038|W|or abuse. If someone accidentally swallows or uses this drug, get||
1344|039|W|medical help right away because fatal breathing problems may||
1344|040|W|occur.||
1344|041|W|   Before using this medication, women of childbearing age should||
1344|042|W|talk with their doctor(s) about the risks and benefits. Tell your||
1344|043|W|doctor if you are pregnant or if you plan to become pregnant.||
1344|044|W|During pregnancy, this medication should be used only when||
1344|045|W|clearly needed. It may slightly increase the risk of birth||
1344|046|W|defects if used during the first two months of pregnancy. Also,||
1344|047|W|using it for a long time or in high doses near the expected||
1344|048|W|delivery date may harm the unborn baby. To lessen the risk, use||
1344|049|W|the smallest effective dose for the shortest possible time.||
1344|050|W|Babies born to mothers who use this drug for a long time may||
1344|051|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1344|052|W|doctor right away if you notice any symptoms in your newborn baby||
1344|053|W|such as crying that doesn't stop, slow/shallow breathing,||
1344|054|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1344|055|W|difficulty gaining weight.||
1344|056|B|||
1344|057|U|USES:  This medication is used to help relieve severe ongoing||
1344|058|U|pain (such as due to arthritis, chronic back pain). Buprenorphine||
1344|059|U|belongs to a class of drugs known as opioid analgesics. It works||
1344|060|U|in the brain to change how your body feels and responds to pain.||
1344|061|U|   The higher strengths of this drug (7.5, 10, 15, or 20||
1344|062|U|micrograms per hour patches) should be used only if you have been||
1344|063|U|regularly taking moderate amounts of opioid pain medication.||
1344|064|U|These strengths may cause overdose (even death) if used by a||
1344|065|U|person who has not been regularly taking opioids.||
1344|066|U|   Do not use this medication to relieve pain that is mild or||
1344|067|U|that will go away in a few days. This medication is not for||
1344|068|U|occasional ("as needed") use.||
1344|069|B|||
1344|070|H|HOW TO USE:  See also Warning section.||
1344|071|H|   Read the Medication Guide and, if available, the Patient||
1344|072|H|Information Leaflet provided by your pharmacist before you start||
1344|073|H|using this medication and each time you get a refill. Learn how||
1344|074|H|to properly use, store, and discard the patches. If you have any||
1344|075|H|questions, ask your doctor or pharmacist.||
1344|076|H|   Use this medication on a regular schedule as directed by your||
1344|077|H|doctor, not as needed for sudden (breakthrough) pain. If you are||
1344|078|H|already using an opioid medication, ask your doctor or pharmacist||
1344|079|H|if you should stop or change how you use your other opioid||
1344|080|H|medication. It may take 24 hours or longer before you have pain||
1344|081|H|relief from buprenorphine patches. Other pain relievers (such as||
1344|082|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1344|083|H|or pharmacist about using buprenorphine safely with other drugs.||
1344|084|H|   Apply this medication to the skin as directed by your doctor.||
1344|085|H|Do not apply on burns, cuts, irritated skin, or skin that has||
1344|086|H|been exposed to radiation (x-ray treatment). Select a dry,||
1344|087|H|non-hairy area on a flat part of your body, such as the upper||
1344|088|H|chest, sides of the chest, upper back, or upper outer arms. In||
1344|089|H|people unable to think clearly (such as due to dementia), apply||
1344|090|H|the patch on the upper back to lessen the chance it might be||
1344|091|H|removed or placed in the mouth. If there is hair on the skin, use||
1344|092|H|scissors to clip the hair as close as possible to the skin. Do||
1344|093|H|not shave hair since this might cause skin irritation. If needed,||
1344|094|H|use water to clean the area. Do not use soap, oils, lotions, or||
1344|095|H|alcohol on the application site. Dry the skin well before||
1344|096|H|applying the patch.||
1344|097|H|   The patch is usually changed every 7 days. To avoid||
1344|098|H|irritation, apply to a different area each time and do not apply||
1344|099|H|to the same site within 3 weeks. Be sure to remove the old patch||
1344|100|H|before applying a new patch. The used patch should be folded in||
1344|101|H|half with the sticky sides together and properly discarded. If||
1344|102|H|your manufacturer has supplied a patch disposal unit, follow||
1344|103|H|directions for its use.||
1344|104|H|   Do not use the patch if it appears to be broken, cut, or||
1344|105|H|damaged. Remove from the sealed pouch, peel off the protective||
1344|106|H|liner, and apply right away to the skin. Press firmly in place||
1344|107|H|with the palm of the hand for about 15 to 30 seconds, making sure||
1344|108|H|the contact is complete (especially around the edges). If your||
1344|109|H|prescribed dose is for more than one patch, apply them right next||
1344|110|H|to each other but make sure the edges of the patches do not touch||
1344|111|H|or overlap. After applying the patch, wash your hands with water||
1344|112|H|only.||
1344|113|H|   You may bathe, shower, or swim while wearing the patch. If you||
1344|114|H|have problems with the patch not sticking at the application||
1344|115|H|site, you may tape the edges in place with certain kinds of first||
1344|116|H|aid tape. Ask your doctor or pharmacist about which type of tape||
1344|117|H|should be used. If this problem lasts, ask your doctor for||
1344|118|H|advice. If the patch falls off before 7 days, a new patch may be||
1344|119|H|applied to a different skin site. Be sure to let your doctor know||
1344|120|H|if this happens.||
1344|121|H|   If you accidentally touch the sticky layer to your skin or||
1344|122|H|handle a cut or damaged patch, wash the area well with clear||
1344|123|H|water. If the patch comes off and accidentally sticks to the skin||
1344|124|H|of another person, immediately remove the patch, wash the area||
1344|125|H|with water, and get medical help for them right away. Do not use||
1344|126|H|soap, alcohol, or other products to wash the area.||
1344|127|H|   The dosage is based on your medical condition and response to||
1344|128|H|treatment. Do not apply more patches than directed, change them||
1344|129|H|more often, or use them for a longer time than prescribed. Your||
1344|130|H|risk for side effects will increase.||
1344|131|H|   Suddenly stopping this medication may cause withdrawal,||
1344|132|H|especially if you have used it for a long time or in high doses.||
1344|133|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1344|134|H|Tell your doctor or pharmacist right away if you have any||
1344|135|H|withdrawal symptoms such as restlessness, mental/mood changes||
1344|136|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1344|137|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1344|138|H|aches, or sudden changes in behavior.||
1344|139|H|   When this medication is used for a long time, it may not work||
1344|140|H|as well. Talk with your doctor if this medication stops working||
1344|141|H|well.||
1344|142|H|   Though it helps many people, this medication may sometimes||
1344|143|H|cause addiction. This risk may be higher if you have a||
1344|144|H|mental/mood disorder or a substance use disorder (such as overuse||
1344|145|H|of or addiction to drugs/alcohol). Use this medication exactly as||
1344|146|H|prescribed to lower the risk of addiction. Ask your doctor or||
1344|147|H|pharmacist for more details.||
1344|148|H|   Tell your doctor if your pain does not get better or if it||
1344|149|H|gets worse, or if you have any new pain.||
1344|150|B|||
1344|151|S|SIDE EFFECTS:  See also Warning section.||
1344|152|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
1344|153|S|drowsiness, dry mouth, or headache may occur. Irritation,||
1344|154|S|itching, or redness at the application site may also occur. Some||
1344|155|S|of these side effects may decrease after you have been using this||
1344|156|S|medication for a while. If any of these effects last or get||
1344|157|S|worse, tell your doctor or pharmacist promptly.||
1344|158|S|   To prevent constipation, eat dietary fiber, drink enough||
1344|159|S|water, and exercise. You may also need to take a laxative. Ask||
1344|160|S|your pharmacist which type of laxative is right for you.||
1344|161|S|   To reduce the risk of dizziness and lightheadedness, get up||
1344|162|S|slowly when rising from a sitting or lying position.||
1344|163|S|   Remember that this medication has been prescribed because your||
1344|164|S|doctor has judged that the benefit to you is greater than the||
1344|165|S|risk of side effects. Many people using this medication do not||
1344|166|S|have serious side effects.||
1344|167|S|   Tell your doctor right away if you have any serious side||
1344|168|S|effects, including: interrupted breathing during sleep (sleep||
1344|169|S|apnea), mental/mood changes (such as agitation, confusion,||
1344|170|S|hallucinations), difficulty urinating, swelling/blistering at the||
1344|171|S|patch application site, signs of your adrenal glands not working||
1344|172|S|well (such as unusual tiredness, weight loss), trouble||
1344|173|S|swallowing.||
1344|174|S|   Get medical help right away if you have any very serious side||
1344|175|S|effects, including: fainting, seizure, slow/shallow breathing,||
1344|176|S|severe drowsiness/difficulty waking up, fast/irregular heartbeat,||
1344|177|S|severe dizziness.||
1344|178|S|   This drug may rarely cause serious liver disease. Get medical||
1344|179|S|help right away if you have any symptoms of liver damage,||
1344|180|S|including: nausea/vomiting that doesn't stop, dark urine, loss of||
1344|181|S|appetite, yellowing eyes/skin, severe stomach/abdominal pain.||
1344|182|S|   A very serious allergic reaction to this drug is rare.||
1344|183|S|However, get medical help right away if you notice any symptoms||
1344|184|S|of a serious allergic reaction, including: rash, itching/swelling||
1344|185|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1344|186|S|breathing.||
1344|187|S|   This is not a complete list of possible side effects. If you||
1344|188|S|notice other effects not listed above, contact your doctor or||
1344|189|S|pharmacist.||
1344|190|S|   In the US -||
1344|191|S|   Call your doctor for medical advice about side effects. You||
1344|192|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1344|193|S|www.fda.gov/medwatch.||
1344|194|S|   In Canada - Call your doctor for medical advice about side||
1344|195|S|effects. You may report side effects to Health Canada at||
1344|196|S|1-866-234-2345.||
1344|197|B|||
1344|198|P|PRECAUTIONS:  Before using buprenorphine, tell your doctor or||
1344|199|P|pharmacist if you are allergic to it; or to adhesives; or if you||
1344|200|P|have any other allergies. This product may contain inactive||
1344|201|P|ingredients, which can cause allergic reactions or other||
1344|202|P|problems. Talk to your pharmacist for more details.||
1344|203|P|   Before using this medication, tell your doctor or pharmacist||
1344|204|P|your medical history, especially of: brain disorders (such as||
1344|205|P|head injury, tumor, seizures), breathing problems (such as||
1344|206|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1344|207|P|kidney disease, liver disease, mental/mood disorders (such as||
1344|208|P|confusion, depression), personal or family history of a substance||
1344|209|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
1344|210|P|stomach/intestinal problems (such as blockage, constipation,||
1344|211|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
1344|212|P|(such as due to enlarged prostate), disease of the pancreas||
1344|213|P|(pancreatitis), gallbladder disease.||
1344|214|P|   Buprenorphine may cause a condition that affects the heart||
1344|215|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1344|216|P|serious (rarely fatal) fast/irregular heartbeat and other||
1344|217|P|symptoms (such as severe dizziness, fainting) that need medical||
1344|218|P|attention right away.||
1344|219|P|   The risk of QT prolongation may be increased if you have||
1344|220|P|certain medical conditions or are taking other drugs that may||
1344|221|P|cause QT prolongation. Before using buprenorphine, tell your||
1344|222|P|doctor or pharmacist of all the drugs you take and if you have||
1344|223|P|any of the following conditions: certain heart problems (heart||
1344|224|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1344|225|P|history of certain heart problems (QT prolongation in the EKG,||
1344|226|P|sudden cardiac death).||
1344|227|P|   Low levels of potassium or magnesium in the blood may also||
1344|228|P|increase your risk of QT prolongation. This risk may increase if||
1344|229|P|you use certain drugs (such as diuretics/"water pills") or if you||
1344|230|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1344|231|P|Talk to your doctor about using buprenorphine safely.||
1344|232|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1344|233|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1344|234|P|machinery, or do anything that needs alertness until you can do||
1344|235|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1344|236|P|are using marijuana (cannabis).||
1344|237|P|   Raising your skin/body temperature may cause overdose. Avoid||
1344|238|P|increasing your skin temperature at or near the application site||
1344|239|P|(for example, using products such as heating pads, electric||
1344|240|P|blankets, hot tubs, heat or tanning lamps). Avoid taking hot||
1344|241|P|baths and sunbathing. Tell your doctor promptly if you develop a||
1344|242|P|fever.||
1344|243|P|   If you are going to have an MRI test, tell testing personnel||
1344|244|P|that you are using this patch. Some patches may contain metals||
1344|245|P|that can cause serious burns during an MRI. Ask your doctor||
1344|246|P|whether you will need to remove your patch before the test and||
1344|247|P|apply a new patch afterward, and how to do so properly.||
1344|248|P|   Before having surgery, tell your doctor or dentist about all||
1344|249|P|the products you use (including prescription drugs,||
1344|250|P|nonprescription drugs, and herbal products).||
1344|251|P|   Older adults may be more sensitive to the effects of this||
1344|252|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
1344|253|P|breathing, and QT prolongation (see above).||
1344|254|P|   During pregnancy, this medication should be used only when||
1344|255|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1344|256|P|benefits with your doctor. (See also Warning section.)||
1344|257|P|   This drug passes into breast milk and may have undesirable||
1344|258|P|effects on a nursing infant. Tell the doctor right away if your||
1344|259|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1344|260|P|breathing. Consult your doctor before breastfeeding.||
1344|261|B|||
1344|262|I|DRUG INTERACTIONS:  See also Warning section.||
1344|263|I|   Drug interactions may change how your medications work or||
1344|264|I|increase your risk for serious side effects. This document does||
1344|265|I|not contain all possible drug interactions. Keep a list of all||
1344|266|I|the products you use (including prescription/nonprescription||
1344|267|I|drugs and herbal products) and share it with your doctor and||
1344|268|I|pharmacist. Do not start, stop, or change the dosage of any||
1344|269|I|medicines without your doctor's approval.||
1344|270|I|   Some products that may interact with this drug include:||
1344|271|I|certain pain medications (mixed opioid agonist-antagonists such||
1344|272|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1344|273|I|samidorphan.||
1344|274|I|   The risk of serious side effects (such as slow/shallow||
1344|275|I|breathing, severe drowsiness/dizziness) may be increased if this||
1344|276|I|medication is used with other products that may also cause||
1344|277|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1344|278|I|if you are taking other products such as other opioid pain or||
1344|279|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1344|280|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1344|281|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1344|282|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1344|283|I|cetirizine, diphenhydramine).||
1344|284|I|   Check the labels on all your medicines (such as allergy or||
1344|285|I|cough-and-cold products) because they may contain ingredients||
1344|286|I|that cause drowsiness. Ask your pharmacist about using those||
1344|287|I|products safely.||
1344|288|I|   This medication may interfere with certain lab tests (such as||
1344|289|I|amylase/lipase levels), possibly causing false test results. Make||
1344|290|I|sure lab personnel and all your doctors know you use this drug.||
1344|291|B|||
1344|292|O|OVERDOSE:  This medication patch may be harmful if chewed or||
1344|293|O|swallowed. If someone has overdosed, remove the patch if||
1344|294|O|possible. For serious symptoms such as passing out or trouble||
1344|295|O|breathing, give them naloxone or nalmefene if available, then||
1344|296|O|call 911. If the person is awake and has no symptoms, call a||
1344|297|O|poison control center right away. US residents can call||
1344|298|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1344|299|O|Symptoms of overdose may include: slow/shallow breathing, slow||
1344|300|O|heartbeat, coma.||
1344|301|B|||
1344|302|N|NOTES:  Do not share this medication with others. Sharing it is||
1344|303|N|against the law.||
1344|304|N|   This medication has been prescribed for your current condition||
1344|305|N|only. Do not use it later for another condition unless told to do||
1344|306|N|so by your doctor. A different medication may be necessary in||
1344|307|N|that case.||
1344|308|B|||
1344|309|D|MISSED DOSE:  If you leave a patch on for more than 7 days,||
1344|310|D|remove the patch and apply a new patch as soon as you remember.||
1344|311|D|Do not double the dose to catch up.||
1344|312|B|||
1344|313|R|STORAGE:  Store at room temperature away from light and moisture.||
1344|314|R|Do not freeze. Keep all medications away from children and pets.||
1344|315|R|See also Warning section.||
1344|316|R|   Do not flush medications down the toilet or pour them into a||
1344|317|R|drain unless instructed to do so. Properly discard this product||
1344|318|R|when it is expired or no longer needed (see also How to Use||
1344|319|R|section). For more details, read the Medication Guide, or consult||
1344|320|R|your pharmacist or local waste disposal company.||
1344|321|B|||
1344|322|A|Information last revised August 2025.||
1344|323|A|Copyright(c) 2025 First Databank, Inc.||
1344|324|B|||
1345|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1345|002|Z|does NOT have all possible information about this product. This||
1345|003|Z|information does not assure that this product is safe, effective,||
1345|004|Z|or appropriate for you. This information is not individual||
1345|005|Z|medical advice and does not substitute for the advice of your||
1345|006|Z|health care professional. Always ask your health care||
1345|007|Z|professional for complete information about this product and your||
1345|008|Z|specific health needs.||
1345|009|B|||
1345|010|T|ONDANSETRON SOLUBLE FILM - ORAL||
1345|011|F|(on-DAN-se-tron)||
1345|012|B|||
1345|013|C|COMMON BRAND NAME(S): Zuplenz||
1345|014|B|||
1345|015|U|USES:  This medication is used alone or with other medications to||
1345|016|U|prevent nausea and vomiting caused by cancer drug treatment||
1345|017|U|(chemotherapy), radiation treatment, or drugs used to put you to||
1345|018|U|sleep before surgery. Ondansetron works by blocking one of the||
1345|019|U|body's natural substances (serotonin) that causes vomiting.||
1345|020|B|||
1345|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
1345|022|H|Instructions for Use if available from your pharmacist before you||
1345|023|H|start using ondansetron oral soluble film and each time you get a||
1345|024|H|refill. If you have any questions, ask your doctor or pharmacist.||
1345|025|H|   This medication is made to be dissolved on top of your tongue.||
1345|026|H|Do not chew or swallow the film whole. If giving this medicine to||
1345|027|H|a young child, help them use it properly.||
1345|028|H|   With dry hands, open the protective foil pouch just before||
1345|029|H|using. Remove one film and place on top of your tongue. Allow it||
1345|030|H|to dissolve completely (usually in 4 to 20 seconds), then swallow||
1345|031|H|it with saliva or with liquid. You do not need to take this||
1345|032|H|product with liquid. If your dose is for more than one film,||
1345|033|H|allow each film to dissolve completely before taking the next||
1345|034|H|film. Wash your hands after taking this medication.||
1345|035|H|   To prevent nausea from chemotherapy, take this medication as||
1345|036|H|directed by your doctor, usually 30 minutes before treatment||
1345|037|H|begins. To prevent nausea from radiation treatment, take this||
1345|038|H|medication 1 to 2 hours before the start of your treatment. To||
1345|039|H|prevent nausea after surgery, take ondansetron 1 hour before the||
1345|040|H|start of surgery.||
1345|041|H|   Carefully follow your doctor's directions for taking this||
1345|042|H|medication. Ondansetron may be taken up to 3 times a day for 1 to||
1345|043|H|2 days after each chemotherapy or radiation treatment. If you are||
1345|044|H|taking this medication on a prescribed schedule, take it||
1345|045|H|regularly in order to get the most benefit from it. To help you||
1345|046|H|remember, take it at the same times each day.||
1345|047|H|   The dosage is based on your medical condition and response to||
1345|048|H|treatment. Children's dosage may also be based on age and weight.||
1345|049|H|Take this medication exactly as directed. Do not take more||
1345|050|H|medication or take it more often than prescribed.||
1345|051|H|   Tell your doctor if your nausea and vomiting lasts or if it||
1345|052|H|gets worse.||
1345|053|B|||
1345|054|S|SIDE EFFECTS:  Headache, lightheadedness, dizziness, drowsiness,||
1345|055|S|tiredness, or constipation may occur. If these effects last or||
1345|056|S|get worse, tell your doctor promptly.||
1345|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
1345|058|S|slowly when rising from a sitting or lying position.||
1345|059|S|   Remember that this medication has been prescribed because your||
1345|060|S|doctor has judged that the benefit to you is greater than the||
1345|061|S|risk of side effects. Many people using this medication do not||
1345|062|S|have serious side effects.||
1345|063|S|   Tell your doctor right away if you have any serious side||
1345|064|S|effects, including: abdominal pain, muscle spasm/stiffness.||
1345|065|S|   Get medical help right away if you have any very serious side||
1345|066|S|effects, including: chest pain, slow/fast/irregular heartbeat,||
1345|067|S|severe dizziness, fainting.||
1345|068|S|   This medication may increase serotonin and rarely cause a very||
1345|069|S|serious condition called serotonin syndrome/toxicity. The risk||
1345|070|S|increases if you are also taking other drugs that increase||
1345|071|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1345|072|S|take (see Drug Interactions section). Get medical help right away||
1345|073|S|if you develop some of the following symptoms: fast heartbeat,||
1345|074|S|hallucinations, loss of coordination, severe dizziness, severe||
1345|075|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1345|076|S|unusual agitation/restlessness.||
1345|077|S|   A very serious allergic reaction to this drug is rare.||
1345|078|S|However, get medical help right away if you notice any symptoms||
1345|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1345|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1345|081|S|breathing.||
1345|082|S|   This is not a complete list of possible side effects. If you||
1345|083|S|notice other effects not listed above, contact your doctor or||
1345|084|S|pharmacist.||
1345|085|S|   In the US -||
1345|086|S|   Call your doctor for medical advice about side effects. You||
1345|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1345|088|S|www.fda.gov/medwatch.||
1345|089|S|   In Canada - Call your doctor for medical advice about side||
1345|090|S|effects. You may report side effects to Health Canada at||
1345|091|S|1-866-234-2345.||
1345|092|B|||
1345|093|P|PRECAUTIONS:  Before taking ondansetron, tell your doctor or||
1345|094|P|pharmacist if you are allergic to it; or if you have any other||
1345|095|P|allergies. This product may contain inactive ingredients, which||
1345|096|P|can cause allergic reactions or other problems. Talk to your||
1345|097|P|pharmacist for more details.||
1345|098|P|   Before using this medication, tell your doctor or pharmacist||
1345|099|P|your medical history, especially of: irregular heartbeat, liver||
1345|100|P|problems, stomach/intestinal problems (such as recent abdominal||
1345|101|P|surgery, ileus).||
1345|102|P|   Ondansetron may cause a condition that affects the heart||
1345|103|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1345|104|P|serious (rarely fatal) fast/irregular heartbeat and other||
1345|105|P|symptoms (such as severe dizziness, fainting) that need medical||
1345|106|P|attention right away.||
1345|107|P|   The risk of QT prolongation may be increased if you have||
1345|108|P|certain medical conditions or are taking other drugs that may||
1345|109|P|cause QT prolongation. Before using ondansetron, tell your doctor||
1345|110|P|or pharmacist of all the drugs you take and if you have any of||
1345|111|P|the following conditions: certain heart problems (heart failure,||
1345|112|P|slow heartbeat, QT prolongation in the EKG), family history of||
1345|113|P|certain heart problems (QT prolongation in the EKG, sudden||
1345|114|P|cardiac death).||
1345|115|P|   Low levels of potassium or magnesium in the blood may also||
1345|116|P|increase your risk of QT prolongation. This risk may increase if||
1345|117|P|you use certain drugs (such as diuretics/"water pills") or if you||
1345|118|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1345|119|P|Talk to your doctor about using ondansetron safely.||
1345|120|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1345|121|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1345|122|P|machinery, or do anything that needs alertness until you can do||
1345|123|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1345|124|P|are using marijuana (cannabis).||
1345|125|P|   Before having surgery, tell your doctor or dentist about all||
1345|126|P|the products you use (including prescription drugs,||
1345|127|P|nonprescription drugs, and herbal products).||
1345|128|P|   Older adults may be more sensitive to the side effects of this||
1345|129|P|drug, especially QT prolongation.||
1345|130|P|   During pregnancy, this medication should be used only when||
1345|131|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1345|132|P|benefits with your doctor.||
1345|133|P|   This medication passes into breast milk. Consult your doctor||
1345|134|P|before breastfeeding.||
1345|135|B|||
1345|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1345|137|I|medications work or increase your risk for serious side effects.||
1345|138|I|This document does not contain all possible drug interactions.||
1345|139|I|Keep a list of all the products you use (including||
1345|140|I|prescription/nonprescription drugs and herbal products) and share||
1345|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
1345|142|I|the dosage of any medicines without your doctor's approval.||
1345|143|I|   Some products that may interact with this drug include:||
1345|144|I|apomorphine, tramadol.||
1345|145|I|   The risk of serotonin syndrome/toxicity increases if you are||
1345|146|I|also taking other drugs that increase serotonin. Examples include||
1345|147|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1345|148|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1345|149|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1345|150|I|serotonin syndrome/toxicity may be more likely when you start or||
1345|151|I|increase the dose of these drugs.||
1345|152|B|||
1345|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1345|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1345|155|O|poison control center right away. US residents can call||
1345|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1345|157|B|||
1345|158|N|NOTES:  Do not share this product with others.||
1345|159|N|   Lab and/or medical tests (such as EKG) should be done while||
1345|160|N|you are taking this medication. Keep all medical and lab||
1345|161|N|appointments. Consult your doctor for more details.||
1345|162|B|||
1345|163|D|MISSED DOSE:  Try to take each dose at the scheduled time. If you||
1345|164|D|miss a dose, take it as soon as you remember unless it is near||
1345|165|D|the time for the next dose. In that case, skip the missed dose.||
1345|166|D|Take your next dose at the regular time. Do not double the dose||
1345|167|D|to catch up.||
1345|168|B|||
1345|169|R|STORAGE:  Store at room temperature away from light and moisture.||
1345|170|R|Do not store in the bathroom. Keep all medications out of reach||
1345|171|R|of children and pets.||
1345|172|R|   Do not flush medications down the toilet or pour them into a||
1345|173|R|drain unless instructed to do so. Properly discard this product||
1345|174|R|when it is expired or no longer needed. Consult your pharmacist||
1345|175|R|or local waste disposal company.||
1345|176|B|||
1345|177|A|Information last revised June 2025.||
1345|178|A|Copyright(c) 2025 First Databank, Inc.||
1345|179|B|||
1346|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1346|002|Z|does NOT have all possible information about this product. This||
1346|003|Z|information does not assure that this product is safe, effective,||
1346|004|Z|or appropriate for you. This information is not individual||
1346|005|Z|medical advice and does not substitute for the advice of your||
1346|006|Z|health care professional. Always ask your health care||
1346|007|Z|professional for complete information about this product and your||
1346|008|Z|specific health needs.||
1346|009|B|||
1346|010|T|CABAZITAXEL - INJECTION||
1346|011|F|(ka-BAZ-i-TAZ-el)||
1346|012|B|||
1346|013|C|COMMON BRAND NAME(S): Jevtana||
1346|014|B|||
1346|015|W|WARNING:  Cabazitaxel may cause a serious blood disorder (a low||
1346|016|W|number of white blood cells). This effect can lower your body's||
1346|017|W|ability to fight an infection and thus lead to serious (rarely||
1346|018|W|fatal) infections. Your doctor will monitor you closely and check||
1346|019|W|your blood often during treatment. You may also receive another||
1346|020|W|medication to reduce the risk of this side effect. If your white||
1346|021|W|blood cell count is too low, you should not receive cabazitaxel.||
1346|022|W|Tell your doctor right away if you develop any signs of infection||
1346|023|W|(such as sore throat that doesn't go away, fever, chills,||
1346|024|W|painful/difficult urination).||
1346|025|W|   Cabazitaxel may rarely cause serious allergic reactions. This||
1346|026|W|drug must not be used in patients who have previously had an||
1346|027|W|allergic reaction to it or to other medications containing||
1346|028|W|polysorbate 80. Your doctor should prescribe other medications||
1346|029|W|(such as antihistamines, H2 blockers, corticosteroids) to help||
1346|030|W|prevent an allergic reaction. Get medical help right away if you||
1346|031|W|develop any signs of an allergic reaction such as rash,||
1346|032|W|itching/swelling (especially of the face/tongue/throat), severe||
1346|033|W|dizziness, trouble breathing.||
1346|034|B|||
1346|035|U|USES:  Cabazitaxel is used to treat prostate cancer. It works by||
1346|036|U|slowing or stopping the growth of cancer cells.||
1346|037|B|||
1346|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1346|039|H|from your pharmacist before you start using cabazitaxel and each||
1346|040|H|time you get a refill. If you have any questions, ask your doctor||
1346|041|H|or pharmacist.||
1346|042|H|   This medication is given by injection into a vein as directed||
1346|043|H|by your doctor, usually every 3 weeks. A health care professional||
1346|044|H|will give you the injection slowly over 1 hour.||
1346|045|H|   Your doctor may prescribe other medications (such as||
1346|046|H|antihistamines, H2 blockers, corticosteroids) before each||
1346|047|H|injection of cabazitaxel to lessen the risk of allergic reactions||
1346|048|H|and prevent side effects such as nausea/vomiting.||
1346|049|H|   The dosage is based on your medical condition, body size, lab||
1346|050|H|tests, response to treatment, and other medications you may be||
1346|051|H|taking. Be sure to tell your doctor and pharmacist about all the||
1346|052|H|products you use (including prescription drugs, nonprescription||
1346|053|H|drugs, and herbal products).||
1346|054|B|||
1346|055|S|SIDE EFFECTS:  See also Warning section.||
1346|056|S|   Loss of appetite, stomach/abdominal pain, or change in sense||
1346|057|S|of taste may occur. If any of these effects last or get worse,||
1346|058|S|tell your doctor or pharmacist promptly.||
1346|059|S|   Nausea, vomiting, and diarrhea can also occur and may be||
1346|060|S|severe. Tell your doctor right away if these effects occur. In||
1346|061|S|some cases, your doctor may prescribe medication to prevent or||
1346|062|S|relieve nausea, vomiting, or diarrhea. Eating several small||
1346|063|S|meals, not eating before treatment, or limiting activity may help||
1346|064|S|to lessen the nausea and vomiting.||
1346|065|S|   Temporary hair loss may occur. Normal hair growth should||
1346|066|S|return after treatment has ended.||
1346|067|S|   Many people using this medication may have serious side||
1346|068|S|effects. However, you have been prescribed this drug because your||
1346|069|S|doctor has judged that the benefit to you is greater than the||
1346|070|S|risk of side effects. Careful monitoring by your doctor may||
1346|071|S|decrease your risk.||
1346|072|S|   Tell your doctor right away if you have any serious side||
1346|073|S|effects, including: constipation that doesn't go away, signs of||
1346|074|S|kidney problems (such as change in the amount of urine,||
1346|075|S|pink/bloody urine), signs of a bladder infection (such as||
1346|076|S|burning/pain when you urinate, urgent or frequent urination,||
1346|077|S|fever), muscle cramps, weakness, dizziness, extreme thirst,||
1346|078|S|unusual tiredness, fast/irregular heartbeat, easy||
1346|079|S|bruising/bleeding, numbness/tingling of arms/legs, severe||
1346|080|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
1346|081|S|coffee grounds.||
1346|082|S|   Get medical help right away if you have any very serious side||
1346|083|S|effects, including: chest pain.||
1346|084|S|   This is not a complete list of possible side effects. If you||
1346|085|S|notice other effects not listed above, contact your doctor or||
1346|086|S|pharmacist.||
1346|087|S|   In the US -||
1346|088|S|   Call your doctor for medical advice about side effects. You||
1346|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1346|090|S|www.fda.gov/medwatch.||
1346|091|S|   In Canada - Call your doctor for medical advice about side||
1346|092|S|effects. You may report side effects to Health Canada at||
1346|093|S|1-866-234-2345.||
1346|094|B|||
1346|095|P|PRECAUTIONS:  Before receiving cabazitaxel, tell your doctor or||
1346|096|P|pharmacist if you are allergic to it; or to similar drugs||
1346|097|P|(taxane-type drugs such as paclitaxel, docetaxel); or to||
1346|098|P|polysorbate 80; or if you have any other allergies. This product||
1346|099|P|may contain other inactive ingredients, which can cause allergic||
1346|100|P|reactions or other problems. Talk to your pharmacist for more||
1346|101|P|details.||
1346|102|P|   Before using this medication, tell your doctor or pharmacist||
1346|103|P|your medical history, especially of: liver disease, lung disease,||
1346|104|P|blood/bone marrow disorders (such as bone marrow suppression,||
1346|105|P|neutropenia, thrombocytopenia, anemia), stomach/abdominal||
1346|106|P|problems (such as ulcers, bleeding, blockage), recent/current||
1346|107|P|infections, radiation treatment.||
1346|108|P|   Cabazitaxel can make you more likely to get infections or may||
1346|109|P|make current infections worse. Stay away from anyone who has an||
1346|110|P|infection that may easily spread (such as chickenpox, COVID-19,||
1346|111|P|measles, flu). Talk to your doctor if you have been exposed to an||
1346|112|P|infection or for more details.||
1346|113|P|   Tell your health care professional that you are using||
1346|114|P|cabazitaxel before having any immunizations/vaccinations. Avoid||
1346|115|P|contact with people who have recently received live vaccines||
1346|116|P|(such as flu vaccine inhaled through the nose).||
1346|117|P|   To lower the chance of getting cut, bruised, or injured, use||
1346|118|P|caution with sharp objects like razors and nail cutters, and||
1346|119|P|avoid activities such as contact sports.||
1346|120|P|   Before having surgery, tell your doctor or dentist about all||
1346|121|P|the products you use (including prescription drugs,||
1346|122|P|nonprescription drugs, and herbal products).||
1346|123|P|   Older adults may be at greater risk for side effects (such as||
1346|124|P|low number of white blood cells, fever, dizziness, bladder||
1346|125|P|infections, dehydration) while using this drug.||
1346|126|P|   This medication should not be used in women, especially during||
1346|127|P|pregnancy or breastfeeding. It may harm an unborn or||
1346|128|P|breastfeeding baby. Men using this medication should ask about||
1346|129|P|reliable forms of birth control while using this medication and||
1346|130|P|for some time after the last dose. Consult your doctor for more||
1346|131|P|details.||
1346|132|B|||
1346|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1346|134|I|medications work or increase your risk for serious side effects.||
1346|135|I|This document does not contain all possible drug interactions.||
1346|136|I|Keep a list of all the products you use (including||
1346|137|I|prescription/nonprescription drugs and herbal products) and share||
1346|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
1346|139|I|the dosage of any medicines without your doctor's approval.||
1346|140|I|   Some products that may interact with this drug include: other||
1346|141|I|drugs that can cause bleeding/bruising (including antiplatelet||
1346|142|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
1346|143|I|"blood thinners" such as warfarin/dabigatran).||
1346|144|I|   Aspirin can increase the risk of bleeding when used with this||
1346|145|I|medication. However, if your doctor has told you to take low-dose||
1346|146|I|aspirin to prevent heart attack or stroke (usually 81-162||
1346|147|I|milligrams a day), you should keep taking the aspirin unless your||
1346|148|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1346|149|I|details.||
1346|150|I|   Other medications can affect the removal of cabazitaxel from||
1346|151|I|your body, which may affect how cabazitaxel works. Examples||
1346|152|I|include azole antifungals (such as itraconazole, ketoconazole),||
1346|153|I|cobicistat, macrolide antibiotics (such as clarithromycin),||
1346|154|I|nefazodone, HIV protease inhibitors (such as nelfinavir),||
1346|155|I|ritonavir, telithromycin, among others.||
1346|156|B|||
1346|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1346|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1346|159|O|poison control center right away. US residents can call||
1346|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1346|161|B|||
1346|162|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1346|163|N|kidney function) must be done while you are using this||
1346|164|N|medication. Keep all medical and lab appointments. Consult your||
1346|165|N|doctor for more details.||
1346|166|B|||
1346|167|D|MISSED DOSE:  It is important to get each dose of this medication||
1346|168|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1346|169|D|right away for a new dosing schedule.||
1346|170|B|||
1346|171|R|STORAGE:  Not applicable. This medication is given in a hospital||
1346|172|R|and will not be stored at home.||
1346|173|B|||
1346|174|M|MEDICAL ALERT:  Your condition can cause complications in a||
1346|175|M|medical emergency. For information about enrolling in MedicAlert,||
1346|176|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1346|177|B|||
1346|178|A|Information last revised April 2025.||
1346|179|A|Copyright(c) 2025 First Databank, Inc.||
1346|180|B|||
1347|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1347|002|Z|does NOT have all possible information about this product. This||
1347|003|Z|information does not assure that this product is safe, effective,||
1347|004|Z|or appropriate for you. This information is not individual||
1347|005|Z|medical advice and does not substitute for the advice of your||
1347|006|Z|health care professional. Always ask your health care||
1347|007|Z|professional for complete information about this product and your||
1347|008|Z|specific health needs.||
1347|009|B|||
1347|010|T|LEVONORGESTREL 1.5 MG - ORAL||
1347|011|F|(LEE-voe-nor-JES-trel)||
1347|012|B|||
1347|013|C|COMMON BRAND NAME(S): Plan B One-Step||
1347|014|B|||
1347|015|U|USES:  Levonorgestrel is used by women to prevent pregnancy after||
1347|016|U|birth control failure (such as a broken condom) or unprotected||
1347|017|U|sex. This medication is an emergency contraceptive and should not||
1347|018|U|be used as a regular form of birth control.||
1347|019|U|   Using this medication will not stop an existing pregnancy or||
1347|020|U|protect you or your partner against sexually transmitted diseases||
1347|021|U|(such as HIV, gonorrhea, chlamydia).||
1347|022|U|   This medication may not work well in women over a certain||
1347|023|U|weight (for example, greater than 164 pounds or 74 kilograms), or||
1347|024|U|if you have used certain other medications within the past month.||
1347|025|U|This effect can result in pregnancy. Talk to your doctor for more||
1347|026|U|details and to see if this medication is right for you (see also||
1347|027|U|Drug Interactions section).||
1347|028|U|   Check the ingredients on the label even if you have used the||
1347|029|U|product before. The manufacturer may have changed the||
1347|030|U|ingredients. Also, products with similar names may contain||
1347|031|U|different ingredients meant for different purposes. Taking the||
1347|032|U|wrong product could harm you.||
1347|033|B|||
1347|034|H|HOW TO USE:  If you are taking the over-the-counter product to||
1347|035|H|self-treat, read all directions on the product package before||
1347|036|H|taking this medication. If you have any questions, talk to your||
1347|037|H|pharmacist. If your doctor has prescribed this medication, take||
1347|038|H|it as directed.||
1347|039|H|   Take 1 tablet by mouth with or without food as soon as||
1347|040|H|possible after unprotected sex. This medication works best when||
1347|041|H|it is taken within 72 hours (3 days) after unprotected sex.||
1347|042|H|   If you vomit within 2 hours of taking this medication, contact||
1347|043|H|your doctor to ask if you need to repeat the dose.||
1347|044|H|   After you take this medication, the time when your period||
1347|045|H|comes and how much you bleed may change. Tell your doctor right||
1347|046|H|away if your period is more than 7 days late. You may need to||
1347|047|H|take a pregnancy test.||
1347|048|H|   If you think you may have a serious medical problem, get||
1347|049|H|medical help right away.||
1347|050|B|||
1347|051|S|SIDE EFFECTS:  Nausea/vomiting, abdominal pain, tiredness,||
1347|052|S|dizziness, changes in vaginal bleeding, breast tenderness, or||
1347|053|S|headache may occur. If any of these effects last or get worse,||
1347|054|S|tell your doctor or pharmacist promptly.||
1347|055|S|   If your doctor has directed you to use this medication,||
1347|056|S|remember that your doctor has judged that the benefit to you is||
1347|057|S|greater than the risk of side effects. Many people using this||
1347|058|S|medication do not have serious side effects.||
1347|059|S|   Tell your doctor right away if you have any serious side||
1347|060|S|effects, including: severe lower stomach pain (especially 3 to 5||
1347|061|S|weeks after taking levonorgestrel).||
1347|062|S|   A very serious allergic reaction to this drug is rare.||
1347|063|S|However, get medical help right away if you notice any symptoms||
1347|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1347|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1347|066|S|breathing.||
1347|067|S|   This is not a complete list of possible side effects. If you||
1347|068|S|notice other effects not listed above, contact your doctor or||
1347|069|S|pharmacist.||
1347|070|S|   In the US -||
1347|071|S|   Call your doctor for medical advice about side effects. You||
1347|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1347|073|S|www.fda.gov/medwatch.||
1347|074|S|   In Canada - Call your doctor for medical advice about side||
1347|075|S|effects. You may report side effects to Health Canada at||
1347|076|S|1-866-234-2345.||
1347|077|B|||
1347|078|P|PRECAUTIONS:  Before taking levonorgestrel, tell your doctor or||
1347|079|P|pharmacist if you are allergic to it; or to other progestins||
1347|080|P|(such as norethindrone); or if you have any other allergies. This||
1347|081|P|product may contain inactive ingredients, which can cause||
1347|082|P|allergic reactions or other problems. Talk to your pharmacist for||
1347|083|P|more details.||
1347|084|P|   Before using this medication, tell your doctor or pharmacist||
1347|085|P|your medical history, especially of: unexplained vaginal||
1347|086|P|bleeding.||
1347|087|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1347|088|P|can make you more dizzy. Do not drive, use machinery, or do||
1347|089|P|anything that needs alertness until you can do it safely. Limit||
1347|090|P|alcoholic beverages. Talk to your doctor if you are using||
1347|091|P|marijuana (cannabis).||
1347|092|P|   Before having surgery, tell your doctor or dentist about all||
1347|093|P|the products you use (including prescription drugs,||
1347|094|P|nonprescription drugs, and herbal products).||
1347|095|P|   This medication must not be used during pregnancy. If you||
1347|096|P|become pregnant or think you may be pregnant, tell your doctor||
1347|097|P|right away.||
1347|098|P|   This medication passes into breast milk but is unlikely to||
1347|099|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1347|100|B|||
1347|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1347|102|I|medications work or increase your risk for serious side effects.||
1347|103|I|This document does not contain all possible drug interactions.||
1347|104|I|Keep a list of all the products you use (including||
1347|105|I|prescription/nonprescription drugs and herbal products) and share||
1347|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
1347|107|I|the dosage of any medicines without your doctor's approval.||
1347|108|I|   Some drugs may cause emergency birth control to work less well||
1347|109|I|by decreasing the amount of birth control hormones in your body.||
1347|110|I|This effect can result in pregnancy. Examples include||
1347|111|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
1347|112|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
1347|113|I|as barbiturates, carbamazepine, felbamate, phenytoin, primidone,||
1347|114|I|topiramate), HIV drugs (such as nelfinavir, nevirapine), among||
1347|115|I|others. Talk to your doctor or pharmacist for more details (see||
1347|116|I|also Uses section).||
1347|117|B|||
1347|118|O|OVERDOSE:  Overdose with this medication is very unlikely.||
1347|119|O|However, if someone has overdosed and has serious symptoms such||
1347|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1347|121|O|poison control center right away. US residents can call||
1347|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1347|123|O|Symptoms of overdose may include: severe nausea/vomiting.||
1347|124|B|||
1347|125|N|NOTES:  Keep all medical and lab appointments.||
1347|126|B|||
1347|127|D|MISSED DOSE:  Not applicable.||
1347|128|B|||
1347|129|R|STORAGE:  Store at room temperature away from light and moisture.||
1347|130|R|Do not store in the bathroom. Keep all medications away from||
1347|131|R|children and pets.||
1347|132|R|   Do not flush medications down the toilet or pour them into a||
1347|133|R|drain unless instructed to do so. Properly discard this product||
1347|134|R|when it is expired or no longer needed. Consult your pharmacist||
1347|135|R|or local waste disposal company.||
1347|136|B|||
1347|137|A|Information last revised May 2024.||
1347|138|A|Copyright(c) 2025 First Databank, Inc.||
1347|139|B|||
1349|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1349|002|Z|does NOT have all possible information about this product. This||
1349|003|Z|information does not assure that this product is safe, effective,||
1349|004|Z|or appropriate for you. This information is not individual||
1349|005|Z|medical advice and does not substitute for the advice of your||
1349|006|Z|health care professional. Always ask your health care||
1349|007|Z|professional for complete information about this product and your||
1349|008|Z|specific health needs.||
1349|009|B|||
1349|010|T|OLMESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE - ORAL||
1349|011|F|(OL-me-SAR-tan/am-LOE-di-peen/HYE-droe-KLOR-oh-THYE-a-zide)||
1349|012|B|||
1349|013|C|COMMON BRAND NAME(S): Tribenzor||
1349|014|B|||
1349|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
1349|016|W|unborn baby if used during pregnancy. It is important to prevent||
1349|017|W|pregnancy while taking this medication. Consult your doctor for||
1349|018|W|more details and to discuss the use of reliable forms of birth||
1349|019|W|control while taking this medication. If you are planning||
1349|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
1349|021|W|your doctor right away.||
1349|022|B|||
1349|023|U|USES:  This product is used to treat high blood pressure||
1349|024|U|(hypertension). Lowering high blood pressure helps prevent||
1349|025|U|strokes, heart attacks, and kidney problems.||
1349|026|U|   This product contains 3 medications: olmesartan, amlodipine,||
1349|027|U|and hydrochlorothiazide. Olmesartan is an angiotensin receptor||
1349|028|U|blocker (ARB) and amlodipine is a calcium channel blocker. They||
1349|029|U|both work by relaxing blood vessels so blood can flow more||
1349|030|U|easily. Hydrochlorothiazide is called a "water pill" (diuretic)||
1349|031|U|and causes your body to get rid of extra salt and water by making||
1349|032|U|more urine.||
1349|033|B|||
1349|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1349|035|H|from your pharmacist before you start taking this medication and||
1349|036|H|each time you get a refill. If you have any questions, ask your||
1349|037|H|doctor or pharmacist.||
1349|038|H|   Take this medication by mouth with or without food as directed||
1349|039|H|by your doctor, usually once daily. If you take this drug too||
1349|040|H|close to bedtime, you may need to wake up to urinate. It is best||
1349|041|H|to take this medication at least 4 hours before your bedtime.||
1349|042|H|   The dosage is based on your medical condition and response to||
1349|043|H|treatment.||
1349|044|H|   Take this medication regularly to get the most benefit from||
1349|045|H|it. To help you remember, take it at the same time each day. Keep||
1349|046|H|taking this medication even if you feel well. Most people with||
1349|047|H|high blood pressure do not feel sick. It may take up to 2 weeks||
1349|048|H|before you get the full benefit of this drug.||
1349|049|H|   If you also take certain drugs to lower your cholesterol (bile||
1349|050|H|acid-binding resins such as cholestyramine, colestipol), take||
1349|051|H|olmesartan/amlodipine/hydrochlorothiazide at least 4 hours before||
1349|052|H|or at least 4 to 6 hours after these medications.||
1349|053|H|   Tell your doctor if your condition does not get better or if||
1349|054|H|it gets worse (your blood pressure readings remain high or||
1349|055|H|increase).||
1349|056|B|||
1349|057|S|SIDE EFFECTS:  Dizziness, lightheadedness, tiredness, or headache||
1349|058|S|may occur as your body adjusts to the medication. If any of these||
1349|059|S|effects last or get worse, tell your doctor or pharmacist||
1349|060|S|promptly.||
1349|061|S|   To reduce the risk of dizziness and lightheadedness, get up||
1349|062|S|slowly when rising from a sitting or lying position.||
1349|063|S|   Remember that this medication has been prescribed because your||
1349|064|S|doctor has judged that the benefit to you is greater than the||
1349|065|S|risk of side effects. Many people using this medication do not||
1349|066|S|have serious side effects.||
1349|067|S|   This product may cause dehydration and electrolyte imbalance.||
1349|068|S|Tell your doctor right away if you have any symptoms of||
1349|069|S|dehydration or electrolyte imbalance, including unusual dry||
1349|070|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
1349|071|S|heartbeat, or confusion.||
1349|072|S|   Tell your doctor right away if you have any serious side||
1349|073|S|effects, including: diarrhea that is severe or doesn't stop,||
1349|074|S|fainting, severe tiredness, big toe/joint pain, swelling||
1349|075|S|hands/ankles/feet, decrease in vision, eye pain, signs of kidney||
1349|076|S|problems (such as change in the amount of urine).||
1349|077|S|   Some people who already have severe heart disease may rarely||
1349|078|S|develop worsening chest pain or a heart attack after starting||
1349|079|S|this medication or increasing the dose. Get medical help right||
1349|080|S|away if you experience: worsening chest pain, symptoms of a heart||
1349|081|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
1349|082|S|unusual sweating).||
1349|083|S|   A very serious allergic reaction to this drug is rare.||
1349|084|S|However, get medical help right away if you notice any symptoms||
1349|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1349|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1349|087|S|breathing.||
1349|088|S|   This is not a complete list of possible side effects. If you||
1349|089|S|notice other effects not listed above, contact your doctor or||
1349|090|S|pharmacist.||
1349|091|S|   In the US -||
1349|092|S|   Call your doctor for medical advice about side effects. You||
1349|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1349|094|S|www.fda.gov/medwatch.||
1349|095|S|   In Canada - Call your doctor for medical advice about side||
1349|096|S|effects. You may report side effects to Health Canada at||
1349|097|S|1-866-234-2345.||
1349|098|B|||
1349|099|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1349|100|P|pharmacist if you are allergic to olmesartan, amlodipine, or||
1349|101|P|hydrochlorothiazide; or if you have any other allergies. This||
1349|102|P|product may contain inactive ingredients, which can cause||
1349|103|P|allergic reactions or other problems. Talk to your pharmacist for||
1349|104|P|more details.||
1349|105|P|   Before using this medication, tell your doctor or pharmacist||
1349|106|P|your medical history, especially of: kidney disease, liver||
1349|107|P|disease, dehydration, untreated electrolytes imbalance (such as||
1349|108|P|high/low potassium, low magnesium, high calcium), gout, lupus, a||
1349|109|P|certain heart valve condition (aortic stenosis), skin cancer.||
1349|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1349|111|P|can make you more dizzy. Do not drive, use machinery, or do||
1349|112|P|anything that needs alertness until you can do it safely. Limit||
1349|113|P|alcoholic beverages. Talk to your doctor if you are using||
1349|114|P|marijuana (cannabis).||
1349|115|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1349|116|P|and cause you to feel lightheaded. Tell your doctor if you have||
1349|117|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1349|118|P|of fluids unless your doctor tells you not to.||
1349|119|P|   If you have diabetes, this product may affect your blood||
1349|120|P|sugar. Check your blood sugar regularly as directed and share the||
1349|121|P|results with your doctor. Your doctor may need to adjust your||
1349|122|P|diabetes medication, exercise program, or diet.||
1349|123|P|   This product may affect your potassium levels. Before using||
1349|124|P|potassium supplements or salt substitutes that contain potassium,||
1349|125|P|consult your doctor or pharmacist.||
1349|126|P|   This medication may make you more sensitive to the sun. It may||
1349|127|P|also increase your risk for skin cancer, especially if you take||
1349|128|P|it for a long time. Limit your time in the sun. Avoid tanning||
1349|129|P|booths and sunlamps. Use sunscreen and wear protective clothing||
1349|130|P|when outdoors. Tell your doctor right away if you get sunburned,||
1349|131|P|have skin blisters/redness, or notice new or changed moles/skin||
1349|132|P|lesions.||
1349|133|P|   Before having surgery, tell your doctor or dentist about all||
1349|134|P|the products you use (including prescription drugs,||
1349|135|P|nonprescription drugs, and herbal products).||
1349|136|P|   Older adults may be more sensitive to the side effects of this||
1349|137|P|drug, especially dizziness and change in the amount of urine||
1349|138|P|(kidney problems).||
1349|139|P|   Tell your doctor if you are pregnant or plan to become||
1349|140|P|pregnant. You should not become pregnant while using this||
1349|141|P|product. Olmesartan may harm an unborn baby. If you become||
1349|142|P|pregnant, talk to your doctor right away about the risks and||
1349|143|P|benefits of this medication. (See also Warning section.)||
1349|144|P|   It is unknown if olmesartan passes into breast milk.||
1349|145|P|Hydrochlorothiazide and amlodipine pass into breast milk. Consult||
1349|146|P|your doctor before breastfeeding.||
1349|147|B|||
1349|148|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
1349|149|I|   Drug interactions may change how your medications work or||
1349|150|I|increase your risk for serious side effects. This document does||
1349|151|I|not contain all possible drug interactions. Keep a list of all||
1349|152|I|the products you use (including prescription/nonprescription||
1349|153|I|drugs and herbal products) and share it with your doctor and||
1349|154|I|pharmacist. Do not start, stop, or change the dosage of any||
1349|155|I|medicines without your doctor's approval.||
1349|156|I|   Some products that may interact with this drug include:||
1349|157|I|aliskiren, dofetilide, lithium, drugs that may increase the level||
1349|158|I|of potassium in the blood (such as sparsentan, ACE inhibitors||
1349|159|I|including benazepril/lisinopril, birth control pills containing||
1349|160|I|drospirenone).||
1349|161|I|   Some products have ingredients that could raise your blood||
1349|162|I|pressure. Tell your pharmacist what products you are using, and||
1349|163|I|ask how to use them safely (especially cough-and-cold products,||
1349|164|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1349|165|I|   This medication may interfere with certain lab tests, possibly||
1349|166|I|causing false test results. Make sure lab personnel and all your||
1349|167|I|doctors know you use this drug.||
1349|168|B|||
1349|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1349|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1349|171|O|poison control center right away. US residents can call||
1349|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1349|173|O|Symptoms of overdose may include: severe dizziness, fainting.||
1349|174|B|||
1349|175|N|NOTES:  Do not share this medication with others.||
1349|176|N|   Lifestyle changes that may help this medication work better||
1349|177|N|include exercising, stopping smoking, and eating a||
1349|178|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1349|179|N|details.||
1349|180|N|   Lab and/or medical tests (including kidney function, blood||
1349|181|N|mineral levels such as potassium, skin exams, cholesterol levels)||
1349|182|N|should be done while you are taking this medication. Keep all||
1349|183|N|medical and lab appointments.||
1349|184|N|   Have your blood pressure checked regularly while taking this||
1349|185|N|medication. Learn how to monitor your own blood pressure at home,||
1349|186|N|and share the results with your doctor.||
1349|187|B|||
1349|188|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1349|189|D|remember. If it is near the time of the next dose, skip the||
1349|190|D|missed dose. Take your next dose at the regular time. Do not||
1349|191|D|double the dose to catch up.||
1349|192|B|||
1349|193|R|STORAGE:  Store at room temperature away from light and moisture.||
1349|194|R|Do not store in the bathroom. Keep all medications away from||
1349|195|R|children and pets.||
1349|196|R|   Do not flush medications down the toilet or pour them into a||
1349|197|R|drain unless instructed to do so. Properly discard this product||
1349|198|R|when it is expired or no longer needed. Consult your pharmacist||
1349|199|R|or local waste disposal company.||
1349|200|B|||
1349|201|A|Information last revised March 2025.||
1349|202|A|Copyright(c) 2025 First Databank, Inc.||
1349|203|B|||
1350|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1350|002|Z|does NOT have all possible information about this product. This||
1350|003|Z|information does not assure that this product is safe, effective,||
1350|004|Z|or appropriate for you. This information is not individual||
1350|005|Z|medical advice and does not substitute for the advice of your||
1350|006|Z|health care professional. Always ask your health care||
1350|007|Z|professional for complete information about this product and your||
1350|008|Z|specific health needs.||
1350|009|B|||
1350|010|T|IMIQUIMOD 3.75% - TOPICAL||
1350|011|F|(im-I-kwi-mod)||
1350|012|B|||
1350|013|C|COMMON BRAND NAME(S): Zyclara||
1350|014|B|||
1350|015|U|USES:  Imiquimod is used to treat actinic keratoses (AK) which||
1350|016|U|are precancerous growths on the skin. AK are caused by too much||
1350|017|U|sun exposure. Treating this condition can decrease the risk of||
1350|018|U|complications from them. It is also used to treat warts on the||
1350|019|U|outside of the genitals/anus. Imiquimod belongs to a group of||
1350|020|U|drugs called immune response modifiers. It is believed to work by||
1350|021|U|helping to activate your immune system to fight these abnormal||
1350|022|U|skin growths.||
1350|023|U|   This product is not recommended for use on children under 12||
1350|024|U|years of age unless specifically directed by your doctor.||
1350|025|B|||
1350|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1350|027|H|from your pharmacist before you start using imiquimod and each||
1350|028|H|time you get a refill. If you have any questions, ask your doctor||
1350|029|H|or pharmacist.||
1350|030|H|   Use this medication on the skin only. Apply this medication to||
1350|031|H|the affected area as directed by your doctor, usually once a day.||
1350|032|H|The number of times you apply this medication depends on the||
1350|033|H|specific skin problem that is being treated. When treating||
1350|034|H|actinic keratoses, apply once a day for 2 weeks. You will then||
1350|035|H|rest the treated skin for the next two weeks by not applying any||
1350|036|H|more imiquimod. After this rest period, you will resume applying||
1350|037|H|this medication once a day for another 2 weeks. When treating||
1350|038|H|warts, apply once a day until the warts clear or up to 8 weeks.||
1350|039|H|   Do not apply this medication to broken skin (such as open||
1350|040|H|wounds, infected areas, rash, burns). Also, do not apply this||
1350|041|H|medication in the eyes, nose, mouth, rectum, or vagina. If you||
1350|042|H|get this medication in those areas, flush with plenty of water.||
1350|043|H|If irritation occurs, talk to your doctor right away.||
1350|044|H|   If you are using the pump, prime the pump as directed before||
1350|045|H|using it for the first time. If you are using the packet, use a||
1350|046|H|new packet of cream for each use. Throw away any partly used||
1350|047|H|packets of medication.||
1350|048|H|   Use this medication regularly in order to get the most benefit||
1350|049|H|from it. To help you remember, use it at the same time each day.||
1350|050|H|Before applying the medication, wash your hands and the area to||
1350|051|H|be treated with soap and water, and dry thoroughly. Apply as||
1350|052|H|directed by your doctor just before going to bed. Wash your hands||
1350|053|H|with soap and water after each application. Do not cover the||
1350|054|H|treated area with bandages or other waterproof coverings. Leave||
1350|055|H|the cream on overnight, usually for about 8 hours. In the||
1350|056|H|morning, wash the treated area with soap and water to remove the||
1350|057|H|cream. Do not bathe or wet the treated area before the prescribed||
1350|058|H|application time has passed. Do not use more imiquimod than||
1350|059|H|prescribed or leave it on longer than prescribed by your doctor.||
1350|060|H|Doing so may cause more severe skin reactions to occur.||
1350|061|H|   Tell your doctor if your condition lasts or gets worse or if||
1350|062|H|new growths appear during treatment.||
1350|063|B|||
1350|064|S|SIDE EFFECTS:  Treatment area reactions may include redness,||
1350|065|S|swelling, itching, burning, pain/tenderness, thickening/hardening||
1350|066|S|of the skin, peeling/flaking/scabbing/crusting, or leaking a||
1350|067|S|clear fluid. Also, changes in skin color may occur and may not go||
1350|068|S|away. If any of these effects last or get worse, tell your doctor||
1350|069|S|or pharmacist promptly.||
1350|070|S|   If the skin reaction is severe (bleeding, formation of||
1350|071|S|sores/blisters/ulcers), imiquimod may need to be temporarily||
1350|072|S|stopped so that the skin can heal. Follow your doctor's||
1350|073|S|directions.||
1350|074|S|   Headache, loss of appetite, dizziness, diarrhea, nausea, or||
1350|075|S|back pain may also occur. If any of these effects last or get||
1350|076|S|worse, tell your doctor or pharmacist promptly.||
1350|077|S|   Remember that this medication has been prescribed because your||
1350|078|S|doctor has judged that the benefit to you is greater than the||
1350|079|S|risk of side effects. Many people using this medication do not||
1350|080|S|have serious side effects.||
1350|081|S|   Tell your doctor right away if you have any serious side||
1350|082|S|effects, including: flu-like symptoms (such as fever, tiredness,||
1350|083|S|muscle aches), swollen lymph nodes, new unusual skin||
1350|084|S|growths/changes, chest pain.||
1350|085|S|   A very serious allergic reaction to this drug is rare.||
1350|086|S|However, get medical help right away if you notice any symptoms||
1350|087|S|of a serious allergic reaction, including: rash, itching/swelling||
1350|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1350|089|S|breathing.||
1350|090|S|   This is not a complete list of possible side effects. If you||
1350|091|S|notice other effects not listed above, contact your doctor or||
1350|092|S|pharmacist.||
1350|093|S|   In the US -||
1350|094|S|   Call your doctor for medical advice about side effects. You||
1350|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1350|096|S|www.fda.gov/medwatch.||
1350|097|S|   In Canada - Call your doctor for medical advice about side||
1350|098|S|effects. You may report side effects to Health Canada at||
1350|099|S|1-866-234-2345.||
1350|100|B|||
1350|101|P|PRECAUTIONS:  Before using imiquimod, tell your doctor or||
1350|102|P|pharmacist if you are allergic to it; or if you have any other||
1350|103|P|allergies. This product may contain inactive ingredients, which||
1350|104|P|can cause allergic reactions or other problems. Talk to your||
1350|105|P|pharmacist for more details.||
1350|106|P|   Before using this medication, tell your doctor or pharmacist||
1350|107|P|your medical history, especially of: immune system problems.||
1350|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1350|109|P|can make you more dizzy. Do not drive, use machinery, or do||
1350|110|P|anything that needs alertness until you can do it safely. Limit||
1350|111|P|alcoholic beverages. Talk to your doctor if you are using||
1350|112|P|marijuana (cannabis).||
1350|113|P|   This medication may make you more sensitive to the sun. Limit||
1350|114|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1350|115|P|sunscreen and wear protective clothing when outdoors. Do not||
1350|116|P|apply this medication onto sunburned skin. Tell your doctor right||
1350|117|P|away if you get sunburned or have skin blisters/redness.||
1350|118|P|   Genital/anal warts are caused by a virus called human||
1350|119|P|papillomavirus (HPV). Since imiquimod does not destroy the virus||
1350|120|P|but only helps to eliminate the wart, new warts may form, even||
1350|121|P|while you are being treated. You may also be able to infect any||
1350|122|P|sexual partner who comes into contact with the areas of skin||
1350|123|P|infected with HPV.||
1350|124|P|   To reduce the risk of spreading HPV to others, always use||
1350|125|P|effective barrier protections (such as latex or polyurethane||
1350|126|P|condoms, dental dams) during all sexual activity. Consult your||
1350|127|P|doctor or pharmacist for more details.||
1350|128|P|   During treatment of genital/anal warts, avoid all sexual||
1350|129|P|contact while the cream is on the skin. Condoms, dental dams, and||
1350|130|P|diaphragms may be weakened by the cream, so they may not work as||
1350|131|P|well to prevent pregnancy or spreading of HPV or HIV.||
1350|132|P|   Before having surgery, tell your doctor or dentist about all||
1350|133|P|the products you use (including prescription drugs,||
1350|134|P|nonprescription drugs, and herbal products).||
1350|135|P|   During pregnancy, this medication should be used only when||
1350|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
1350|137|P|   It is unknown if this drug passes into breast milk. Consult||
1350|138|P|your doctor before breastfeeding.||
1350|139|B|||
1350|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1350|141|I|medications work or increase your risk for serious side effects.||
1350|142|I|This document does not contain all possible drug interactions.||
1350|143|I|Keep a list of all the products you use (including||
1350|144|I|prescription/nonprescription drugs and herbal products) and share||
1350|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
1350|146|I|the dosage of any medicines without your doctor's approval.||
1350|147|I|   Do not apply this product on the same area of skin with other||
1350|148|I|imiquimod-containing products.||
1350|149|B|||
1350|150|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1350|151|O|has overdosed and has serious symptoms such as passing out or||
1350|152|O|trouble breathing, call 911. Otherwise, call a poison control||
1350|153|O|center right away. US residents can call 1-800-222-1222. Canada||
1350|154|O|residents can call 1-844-764-7669.||
1350|155|B|||
1350|156|N|NOTES:  Do not share this medication with others.||
1350|157|N|   Keep all medical appointments.||
1350|158|B|||
1350|159|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1350|160|D|If you do not remember until the next day, skip the missed dose.||
1350|161|D|Use your next dose at the regular time in the evening. Do not||
1350|162|D|double the dose to catch up.||
1350|163|B|||
1350|164|R|STORAGE:  Store at room temperature. Do not freeze. Store the||
1350|165|R|pump upright. Keep all medications away from children and pets.||
1350|166|R|   Do not flush medications down the toilet or pour them into a||
1350|167|R|drain unless instructed to do so. Properly discard this product||
1350|168|R|when it is expired or no longer needed. Consult your pharmacist||
1350|169|R|or local waste disposal company.||
1350|170|B|||
1350|171|A|Information last revised October 2024.||
1350|172|A|Copyright(c) 2025 First Databank, Inc.||
1350|173|B|||
1351|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1351|002|Z|does NOT have all possible information about this product. This||
1351|003|Z|information does not assure that this product is safe, effective,||
1351|004|Z|or appropriate for you. This information is not individual||
1351|005|Z|medical advice and does not substitute for the advice of your||
1351|006|Z|health care professional. Always ask your health care||
1351|007|Z|professional for complete information about this product and your||
1351|008|Z|specific health needs.||
1351|009|B|||
1351|010|T|DOXEPIN (SLEEP) - ORAL||
1351|011|F|(dox-EH-pin)||
1351|012|B|||
1351|013|C|COMMON BRAND NAME(S): Silenor||
1351|014|B|||
1351|015|U|USES:  This medication is used to treat a certain sleep problem||
1351|016|U|(insomnia). It may help you stay asleep longer and reduce the||
1351|017|U|number of times you awaken during the night. Doxepin belongs to a||
1351|018|U|class of drugs known as tricyclic antidepressants. It is not||
1351|019|U|known how this medication improves sleep, though it may be due to||
1351|020|U|blocking histamine receptors.||
1351|021|B|||
1351|022|H|HOW TO USE:  Read the Medication Guide provided by your||
1351|023|H|pharmacist before you start taking doxepin and each time you get||
1351|024|H|a refill. If you have any questions, ask your doctor or||
1351|025|H|pharmacist.||
1351|026|H|   Take this medication by mouth on an empty stomach as directed||
1351|027|H|by your doctor, usually once nightly within 30 minutes before||
1351|028|H|bedtime. Do not take it within 3 hours of a meal because the||
1351|029|H|effect of the medication will be delayed.||
1351|030|H|   Do not take this medication unless you are able to get a full||
1351|031|H|night of sleep (7 to 8 hours) before you must be active again.||
1351|032|H|   The dosage is based on your medical condition, age, and||
1351|033|H|response to treatment. Do not take more than 6 milligrams per||
1351|034|H|day.||
1351|035|H|   Use this medication regularly to get the most benefit from it.||
1351|036|H|To help you remember, take it at the same time each day.||
1351|037|H|   Tell your doctor if your condition lasts or gets worse after 7||
1351|038|H|to 10 days.||
1351|039|B|||
1351|040|S|SIDE EFFECTS:  Drowsiness or nausea may occur. If either of these||
1351|041|S|effects last or get worse, tell your doctor or pharmacist||
1351|042|S|promptly.||
1351|043|S|   Remember that this medication has been prescribed because your||
1351|044|S|doctor has judged that the benefit to you is greater than the||
1351|045|S|risk of side effects. Many people using this medication do not||
1351|046|S|have serious side effects.||
1351|047|S|   Rarely, after taking this drug, people have gotten out of bed||
1351|048|S|and driven vehicles while not fully awake ("sleep-driving").||
1351|049|S|People have also sleepwalked, prepared/eaten food, made phone||
1351|050|S|calls, or had sex while not fully awake. Often, these people do||
1351|051|S|not remember these events. This problem can be dangerous to you||
1351|052|S|or to others. If you find out that you have done any of these||
1351|053|S|activities after taking this medication, tell your doctor right||
1351|054|S|away. Your risk is increased if you use alcohol or other||
1351|055|S|medications that can make you drowsy while taking doxepin.||
1351|056|S|   At higher doses, doxepin is used to treat a variety of other||
1351|057|S|conditions, including depression and other mental/mood disorders.||
1351|058|S|It can help prevent suicidal thoughts/attempts and provide other||
1351|059|S|important benefits. However, studies have shown that a small||
1351|060|S|number of people (especially people younger than 25) who take||
1351|061|S|antidepressants for any condition may experience worsening||
1351|062|S|depression, other mental/mood symptoms, or suicidal||
1351|063|S|thoughts/attempts. It is very important to talk with the doctor||
1351|064|S|about the risks and benefits of antidepressant medication||
1351|065|S|(especially for people younger than 25), even if treatment is not||
1351|066|S|for a mental/mood condition. Tell the doctor right away if you||
1351|067|S|notice worsening depression/other psychiatric conditions, unusual||
1351|068|S|behavior changes (including possible suicidal thoughts/attempts),||
1351|069|S|or other mental/mood changes (including new/worsening anxiety,||
1351|070|S|panic attacks, irritability, hostile/angry feelings, impulsive||
1351|071|S|actions, severe restlessness, very rapid speech). Be especially||
1351|072|S|watchful for these symptoms if a new antidepressant is started or||
1351|073|S|when the dose is changed.||
1351|074|S|   Get medical help right away if you have any very serious side||
1351|075|S|effects, including: eye pain/swelling/redness, widened pupils,||
1351|076|S|vision changes (such as seeing rainbows around lights at night,||
1351|077|S|blurred vision).||
1351|078|S|   This medication may increase serotonin and rarely cause a very||
1351|079|S|serious condition called serotonin syndrome/toxicity. The risk||
1351|080|S|increases if you are also taking other drugs that increase||
1351|081|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1351|082|S|take (see Drug Interactions section). Get medical help right away||
1351|083|S|if you develop some of the following symptoms: fast heartbeat,||
1351|084|S|hallucinations, loss of coordination, severe dizziness, severe||
1351|085|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1351|086|S|unusual agitation/restlessness.||
1351|087|S|   A very serious allergic reaction to this drug is rare.||
1351|088|S|However, get medical help right away if you notice any symptoms||
1351|089|S|of a serious allergic reaction, including: rash, itching/swelling||
1351|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1351|091|S|breathing.||
1351|092|S|   This is not a complete list of possible side effects. If you||
1351|093|S|notice other effects not listed above, contact your doctor or||
1351|094|S|pharmacist.||
1351|095|S|   In the US -||
1351|096|S|   Call your doctor for medical advice about side effects. You||
1351|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1351|098|S|www.fda.gov/medwatch.||
1351|099|S|   In Canada - Call your doctor for medical advice about side||
1351|100|S|effects. You may report side effects to Health Canada at||
1351|101|S|1-866-234-2345.||
1351|102|B|||
1351|103|P|PRECAUTIONS:  Before taking doxepin, tell your doctor or||
1351|104|P|pharmacist if you are allergic to it; or to other tricyclic||
1351|105|P|antidepressants (such as amoxapine); or if you have any other||
1351|106|P|allergies. This product may contain inactive ingredients, which||
1351|107|P|can cause allergic reactions or other problems. Talk to your||
1351|108|P|pharmacist for more details.||
1351|109|P|   Before using this medication, tell your doctor or pharmacist||
1351|110|P|your medical history, especially of: problems urinating (urinary||
1351|111|P|retention), personal or family history of glaucoma (angle-closure||
1351|112|P|type).||
1351|113|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
1351|114|P|can make you more drowsy. Do not drive, use machinery, or do||
1351|115|P|anything that needs alertness until you can do it safely. Avoid||
1351|116|P|alcoholic beverages. Talk to your doctor if you are using||
1351|117|P|marijuana (cannabis).||
1351|118|P|   Before having surgery, tell your doctor or dentist about all||
1351|119|P|the products you use (including prescription drugs,||
1351|120|P|nonprescription drugs, and herbal products).||
1351|121|P|   During pregnancy, this medication should be used only when||
1351|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
1351|123|P|Babies born to mothers who have used this drug during the last 3||
1351|124|P|months of pregnancy may rarely develop withdrawal symptoms such||
1351|125|P|as feeding/breathing difficulties, seizures, muscle stiffness, or||
1351|126|P|constant crying. If you notice any of these symptoms in your||
1351|127|P|newborn, tell the doctor promptly.||
1351|128|P|   This medication passes into breast milk and may have||
1351|129|P|undesirable effects on a nursing infant. Breastfeeding is not||
1351|130|P|recommended while using this medication. Consult your doctor||
1351|131|P|before breastfeeding.||
1351|132|B|||
1351|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1351|134|I|medications work or increase your risk for serious side effects.||
1351|135|I|This document does not contain all possible drug interactions.||
1351|136|I|Keep a list of all the products you use (including||
1351|137|I|prescription/nonprescription drugs and herbal products) and share||
1351|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
1351|139|I|the dosage of any medicines without your doctor's approval.||
1351|140|I|   A product that may interact with this drug is: cimetidine.||
1351|141|I|   Taking MAO inhibitors with this medication may cause a serious||
1351|142|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1351|143|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1351|144|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1351|145|I|selegiline, tranylcypromine) during treatment with this||
1351|146|I|medication. Most MAO inhibitors should also not be taken for two||
1351|147|I|weeks before and after treatment with this medication. Ask your||
1351|148|I|doctor when to start or stop taking this medication.||
1351|149|I|   The risk of serotonin syndrome/toxicity increases if you are||
1351|150|I|also taking other drugs that increase serotonin. Examples include||
1351|151|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
1351|152|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1351|153|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1351|154|I|serotonin syndrome/toxicity may be more likely when you start or||
1351|155|I|increase the dose of these drugs.||
1351|156|I|   Tell your doctor or pharmacist if you are taking other||
1351|157|I|products that cause drowsiness such as opioid pain or cough||
1351|158|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1351|159|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
1351|160|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1351|161|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1351|162|I|diphenhydramine).||
1351|163|I|   Check the labels on all your medicines (such as allergy or||
1351|164|I|cough-and-cold products) because they may contain ingredients||
1351|165|I|that cause drowsiness. Ask your pharmacist about using those||
1351|166|I|products safely.||
1351|167|B|||
1351|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1351|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1351|170|O|poison control center right away. US residents can call||
1351|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1351|172|O|Symptoms of overdose may include: extreme drowsiness,||
1351|173|O|hallucinations, fast/irregular heartbeat, fainting, slow/shallow||
1351|174|O|breathing, seizures.||
1351|175|B|||
1351|176|N|NOTES:  Do not share this medication with others.||
1351|177|N|   This medication has been prescribed for your current condition||
1351|178|N|only. Do not use it later for other conditions unless directed by||
1351|179|N|your doctor. A different medication may be necessary in those||
1351|180|N|cases.||
1351|181|N|   Usually, insomnia is temporary and requires sleep medications||
1351|182|N|only for a short time. If you require treatment for more than 7||
1351|183|N|to 10 days, lab and/or medical tests should be done to find the||
1351|184|N|cause of your sleep problem. Keep all medical and lab||
1351|185|N|appointments. Consult your doctor for more details.||
1351|186|N|   As you get older, your sleep pattern may naturally change and||
1351|187|N|your sleep may be interrupted several times during the night.||
1351|188|N|Talk to your doctor or pharmacist for ways to improve your sleep||
1351|189|N|without medication, such as avoiding caffeine and alcohol close||
1351|190|N|to bedtime, avoiding daytime naps, and avoiding going to bed too||
1351|191|N|early each night.||
1351|192|B|||
1351|193|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
1351|194|D|if it is still near bedtime and you have trouble falling asleep.||
1351|195|D|If it is already the next day, take your next dose at the regular||
1351|196|D|time that night at bedtime. Do not double the dose to catch up.||
1351|197|B|||
1351|198|R|STORAGE:  Store at room temperature away from light and moisture.||
1351|199|R|Do not store in the bathroom. Keep all medications away from||
1351|200|R|children and pets.||
1351|201|R|   Do not flush medications down the toilet or pour them into a||
1351|202|R|drain unless instructed to do so. Properly discard this product||
1351|203|R|when it is expired or no longer needed. Consult your pharmacist||
1351|204|R|or local waste disposal company.||
1351|205|B|||
1351|206|A|Information last revised July 2025.||
1351|207|A|Copyright(c) 2025 First Databank, Inc.||
1351|208|B|||
1353|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1353|002|Z|does NOT have all possible information about this product. This||
1353|003|Z|information does not assure that this product is safe, effective,||
1353|004|Z|or appropriate for you. This information is not individual||
1353|005|Z|medical advice and does not substitute for the advice of your||
1353|006|Z|health care professional. Always ask your health care||
1353|007|Z|professional for complete information about this product and your||
1353|008|Z|specific health needs.||
1353|009|B|||
1353|010|T|ACYCLOVIR/HYDROCORTISONE CREAM - TOPICAL||
1353|011|F|(ay-SYE-kloe-vir/HYE-droe-KOR-ti-sone)||
1353|012|B|||
1353|013|C|COMMON BRAND NAME(S): Xerese||
1353|014|B|||
1353|015|U|USES:  This medication contains 2 ingredients: acyclovir and||
1353|016|U|hydrocortisone. It is used to treat cold sores/fever blisters||
1353|017|U|caused by a virus (herpes simplex). Acyclovir is an antiviral||
1353|018|U|medication that works by stopping the growth of the virus.||
1353|019|U|Hydrocortisone is a corticosteroid that helps relieve itching,||
1353|020|U|pain, and burning symptoms. This medication can speed up healing||
1353|021|U|of cold sores, but it does not cure herpes or prevent passing the||
1353|022|U|infection to someone else. It also does not prevent cold sores||
1353|023|U|from returning.||
1353|024|B|||
1353|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1353|026|H|from your pharmacist before you start using this medication and||
1353|027|H|each time you get a refill. If you have any questions, ask your||
1353|028|H|doctor or pharmacist.||
1353|029|H|   Use this medication at the first sign of a cold sore. Wash||
1353|030|H|your hands with soap and water before and after applying this||
1353|031|H|medication. Clean and dry the affected area before applying the||
1353|032|H|medication. Apply a thin layer on the affected area as directed||
1353|033|H|by your doctor, usually 5 times a day (every 3 to 4 hours) for 5||
1353|034|H|days. Apply enough cream to cover all affected areas. Do not rub||
1353|035|H|the area because it may spread to other areas around your mouth||
1353|036|H|or make your cold sore worse. Do not apply other skin products||
1353|037|H|(including make-up, sunscreen, or lip balm) or cover the affected||
1353|038|H|area with a bandage. To prevent washing off the medication, do||
1353|039|H|not bathe, shower, or swim for 30 minutes after application.||
1353|040|H|   Do not apply this medication in the eyes or nose, inside the||
1353|041|H|mouth, or on the genitals.||
1353|042|H|   Cold sores (herpes) can spread easily.||
1353|043|H|Acyclovir/hydrocortisone cream does not prevent the spread of||
1353|044|H|herpes. Avoid sharing eating utensils, cups, razors, or towels||
1353|045|H|during an outbreak. Also, try not to touch the cold sore||
1353|046|H|(including kissing), and wash your hands if you do touch the cold||
1353|047|H|sore.||
1353|048|H|   Use this product regularly to get the most benefit from it.||
1353|049|H|Tell your doctor if your condition lasts or gets worse after 2||
1353|050|H|weeks.||
1353|051|B|||
1353|052|S|SIDE EFFECTS:  Dry/cracked lips, burning, stinging, redness, skin||
1353|053|S|color changes, or dry/flaky skin may occur. If any of these||
1353|054|S|effects last or get worse, tell your doctor or pharmacist||
1353|055|S|promptly.||
1353|056|S|   Remember that this medication has been prescribed because your||
1353|057|S|doctor has judged that the benefit to you is greater than the||
1353|058|S|risk of side effects. Many people using this medication do not||
1353|059|S|have serious side effects.||
1353|060|S|   A very serious allergic reaction to this drug is rare.||
1353|061|S|However, get medical help right away if you notice any symptoms||
1353|062|S|of a serious allergic reaction, including: rash, itching/swelling||
1353|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1353|064|S|breathing.||
1353|065|S|   This is not a complete list of possible side effects. If you||
1353|066|S|notice other effects not listed above, contact your doctor or||
1353|067|S|pharmacist.||
1353|068|S|   In the US -||
1353|069|S|   Call your doctor for medical advice about side effects. You||
1353|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1353|071|S|www.fda.gov/medwatch.||
1353|072|S|   In Canada - Call your doctor for medical advice about side||
1353|073|S|effects. You may report side effects to Health Canada at||
1353|074|S|1-866-234-2345.||
1353|075|B|||
1353|076|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1353|077|P|pharmacist if you are allergic to acyclovir or hydrocortisone; or||
1353|078|P|if you have any other allergies. This product may contain||
1353|079|P|inactive ingredients, which can cause allergic reactions or other||
1353|080|P|problems. Talk to your pharmacist for more details.||
1353|081|P|   Before using this medication, tell your doctor or pharmacist||
1353|082|P|your medical history.||
1353|083|P|   Before having surgery, tell your doctor or dentist about all||
1353|084|P|the products you use (including prescription drugs,||
1353|085|P|nonprescription drugs, and herbal products).||
1353|086|P|   Tell your doctor if you are pregnant before using this||
1353|087|P|medication.||
1353|088|P|   This product may pass into breast milk in small amounts.||
1353|089|P|However, it is unlikely to harm a nursing infant. Consult your||
1353|090|P|doctor before breastfeeding.||
1353|091|B|||
1353|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1353|093|I|medications work or increase your risk for serious side effects.||
1353|094|I|This document does not contain all possible drug interactions.||
1353|095|I|Keep a list of all the products you use (including||
1353|096|I|prescription/nonprescription drugs and herbal products) and share||
1353|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
1353|098|I|the dosage of any medicines without your doctor's approval.||
1353|099|B|||
1353|100|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1353|101|O|has overdosed and has serious symptoms such as passing out or||
1353|102|O|trouble breathing, call 911. Otherwise, call a poison control||
1353|103|O|center right away. US residents can call 1-800-222-1222. Canada||
1353|104|O|residents can call 1-844-764-7669.||
1353|105|B|||
1353|106|N|NOTES:  Do not share this medication with others. Doing so may||
1353|107|N|spread the infection.||
1353|108|N|   Try to avoid or prevent conditions that stress your body and||
1353|109|N|can trigger a cold sore outbreak, such as getting a cold or flu,||
1353|110|N|not getting enough sleep, or staying in the sun without applying||
1353|111|N|sunblock.||
1353|112|B|||
1353|113|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1353|114|D|If it is near the time of the next dose, skip the missed dose.||
1353|115|D|Use your next dose at the regular time. Do not double the dose to||
1353|116|D|catch up.||
1353|117|B|||
1353|118|R|STORAGE:  Store at room temperature. Keep all medications away||
1353|119|R|from children and pets.||
1353|120|R|   Do not flush medications down the toilet or pour them into a||
1353|121|R|drain unless instructed to do so. Properly discard this product||
1353|122|R|when it is expired or no longer needed. Consult your pharmacist||
1353|123|R|or local waste disposal company.||
1353|124|B|||
1353|125|A|Information last revised May 2024.||
1353|126|A|Copyright(c) 2025 First Databank, Inc.||
1353|127|B|||
1354|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1354|002|Z|does NOT have all possible information about this product. This||
1354|003|Z|information does not assure that this product is safe, effective,||
1354|004|Z|or appropriate for you. This information is not individual||
1354|005|Z|medical advice and does not substitute for the advice of your||
1354|006|Z|health care professional. Always ask your health care||
1354|007|Z|professional for complete information about this product and your||
1354|008|Z|specific health needs.||
1354|009|B|||
1354|010|T|VORINOSTAT - ORAL||
1354|011|F|(vor-IN-oh-stat)||
1354|012|B|||
1354|013|C|COMMON BRAND NAME(S): Zolinza||
1354|014|B|||
1354|015|U|USES:  Vorinostat is used to treat a certain type of cancer||
1354|016|U|(CTCL-cutaneous T-cell lymphoma). It works by slowing or stopping||
1354|017|U|the growth of cancer cells.||
1354|018|B|||
1354|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1354|020|H|from your pharmacist before you start taking vorinostat and each||
1354|021|H|time you get a refill. If you have any questions, ask your doctor||
1354|022|H|or pharmacist.||
1354|023|H|   Take this medication by mouth with food as directed by your||
1354|024|H|doctor, usually once daily. Swallow the capsules whole. Do not||
1354|025|H|crush, chew, or open the capsules. To prevent dehydration while||
1354|026|H|taking this medication, drink at least 8 glasses of water (8||
1354|027|H|ounces/240 milliliters each) throughout the day unless your||
1354|028|H|doctor directs you otherwise.||
1354|029|H|   Do not use capsules that are opened or crushed. If your skin||
1354|030|H|or eyes come in contact with the powder inside the capsule, wash||
1354|031|H|the area well with plenty of water and call your doctor.||
1354|032|H|   The dosage is based on your medical condition and response to||
1354|033|H|treatment. Do not increase your dose or take this medication more||
1354|034|H|often than prescribed. Your condition will not improve any||
1354|035|H|faster, and the risk of serious side effects may be increased.||
1354|036|H|   Since this drug can be absorbed through the skin and lungs,||
1354|037|H|women who are pregnant or who may become pregnant should not||
1354|038|H|handle this medication or breathe the dust from the capsules.||
1354|039|H|   Tell your doctor if your condition does not get better or if||
1354|040|H|it gets worse.||
1354|041|B|||
1354|042|S|SIDE EFFECTS:  Tiredness, loss of appetite, weight loss,||
1354|043|S|dizziness, dry mouth, change in the sense of taste, hair loss,||
1354|044|S|headache, or cough may occur. If any of these effects last or get||
1354|045|S|worse, tell your doctor or pharmacist promptly.||
1354|046|S|   Nausea, vomiting, and diarrhea can also occur and may be||
1354|047|S|severe. Tell your doctor right away if these effects occur. In||
1354|048|S|some cases, your doctor may prescribe medication to prevent or||
1354|049|S|relieve them. Eating several small meals, not eating before||
1354|050|S|treatment, or limiting activity may help to lessen the nausea and||
1354|051|S|vomiting.||
1354|052|S|   People using this medication may have serious side effects.||
1354|053|S|However, you have been prescribed this drug because your doctor||
1354|054|S|has judged that the benefit to you is greater than the risk of||
1354|055|S|side effects. Careful monitoring by your doctor may decrease your||
1354|056|S|risk.||
1354|057|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
1354|058|S|Contact your doctor promptly if you notice any symptoms of||
1354|059|S|dehydration, such as unusual decreased urination, unusual dry||
1354|060|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness.||
1354|061|S|   This medication may rarely make your blood sugar rise, which||
1354|062|S|can cause or worsen diabetes. Tell your doctor right away if you||
1354|063|S|have symptoms of high blood sugar such as increased||
1354|064|S|thirst/urination. If you already have diabetes, check your blood||
1354|065|S|sugar regularly as directed and share the results with your||
1354|066|S|doctor. Your doctor may need to adjust your diabetes medication,||
1354|067|S|exercise program, or diet.||
1354|068|S|   This medication decreases bone marrow function, an effect that||
1354|069|S|may lead to a low number of blood cells such as red cells, white||
1354|070|S|cells, and platelets. This effect can cause anemia, decrease your||
1354|071|S|body's ability to fight an infection, or cause easy||
1354|072|S|bruising/bleeding. You may be at an increased risk for||
1354|073|S|stomach/intestine bleeding if you are taking certain medications||
1354|074|S|(see also Drug Interaction section). Tell your doctor right away||
1354|075|S|if you develop any of the following unlikely symptoms: unusual||
1354|076|S|tiredness, pale skin, signs of infection (such as sore throat||
1354|077|S|that doesn't go away, fever, chills), easy bruising/bleeding,||
1354|078|S|signs of stomach/intestine bleeding (such as black/bloody stools,||
1354|079|S|vomit that contains blood or looks like coffee grounds,||
1354|080|S|dizziness).||
1354|081|S|   Tell your doctor right away if you have any serious side||
1354|082|S|effects, including: signs of low levels of||
1354|083|S|magnesium/potassium/calcium in the blood (such as severe muscle||
1354|084|S|spasms/cramps, irregular heartbeat, mental/mood changes,||
1354|085|S|seizures).||
1354|086|S|   This medication may rarely cause blood clots in the lungs or||
1354|087|S|legs. You may be at increased risk for blood clots if you have a||
1354|088|S|history of blood clots. Get medical help right away if any of||
1354|089|S|these side effects occur: chest pain, pain/swelling/warmth in the||
1354|090|S|groin/calf, trouble breathing.||
1354|091|S|   Get medical help right away if you have any very serious side||
1354|092|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1354|093|S|fainting.||
1354|094|S|   A very serious allergic reaction to this drug is rare.||
1354|095|S|However, get medical help right away if you notice any symptoms||
1354|096|S|of a serious allergic reaction, including: rash, itching/swelling||
1354|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1354|098|S|breathing.||
1354|099|S|   This is not a complete list of possible side effects. If you||
1354|100|S|notice other effects not listed above, contact your doctor or||
1354|101|S|pharmacist.||
1354|102|S|   In the US -||
1354|103|S|   Call your doctor for medical advice about side effects. You||
1354|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1354|105|S|www.fda.gov/medwatch.||
1354|106|S|   In Canada - Call your doctor for medical advice about side||
1354|107|S|effects. You may report side effects to Health Canada at||
1354|108|S|1-866-234-2345.||
1354|109|B|||
1354|110|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1354|111|P|pharmacist if you are allergic to it; or if you have any other||
1354|112|P|allergies. This product may contain inactive ingredients, which||
1354|113|P|can cause allergic reactions or other problems. Talk to your||
1354|114|P|pharmacist for more details.||
1354|115|P|   Before using this medication, tell your doctor or pharmacist||
1354|116|P|your medical history, especially of: liver disease, certain||
1354|117|P|mineral imbalances (such as low levels of potassium or magnesium||
1354|118|P|in the blood), blood clots.||
1354|119|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1354|120|P|can make you more dizzy. Do not drive, use machinery, or do||
1354|121|P|anything that needs alertness until you can do it safely. Limit||
1354|122|P|alcoholic beverages. Talk to your doctor if you are using||
1354|123|P|marijuana (cannabis).||
1354|124|P|   Vorinostat may cause a condition that affects the heart rhythm||
1354|125|P|(QT prolongation). QT prolongation can rarely cause serious||
1354|126|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1354|127|P|as severe dizziness, fainting) that need medical attention right||
1354|128|P|away.||
1354|129|P|   The risk of QT prolongation may be increased if you have||
1354|130|P|certain medical conditions or are taking other drugs that may||
1354|131|P|cause QT prolongation. Before using vorinostat, tell your doctor||
1354|132|P|or pharmacist of all the drugs you take and if you have any of||
1354|133|P|the following conditions: certain heart problems (heart failure,||
1354|134|P|slow heartbeat, QT prolongation in the EKG), family history of||
1354|135|P|certain heart problems (QT prolongation in the EKG, sudden||
1354|136|P|cardiac death).||
1354|137|P|   Low levels of potassium or magnesium in the blood may also||
1354|138|P|increase your risk of QT prolongation. This risk may increase if||
1354|139|P|you use certain drugs (such as diuretics/"water pills") or if you||
1354|140|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1354|141|P|Talk to your doctor about using vorinostat safely.||
1354|142|P|   Before having surgery, tell your doctor or dentist about all||
1354|143|P|the products you use (including prescription drugs,||
1354|144|P|nonprescription drugs, and herbal products).||
1354|145|P|   Older adults may be more sensitive to the side effects of this||
1354|146|P|drug, especially QT prolongation.||
1354|147|P|   Tell your doctor if you are pregnant or plan to become||
1354|148|P|pregnant. You should not become pregnant while using vorinostat.||
1354|149|P|Vorinostat may harm an unborn baby. Your doctor should order a||
1354|150|P|pregnancy test before you start this medication. Women using this||
1354|151|P|medication should ask about reliable forms of birth control||
1354|152|P|during treatment and for at least 6 months after the last dose.||
1354|153|P|Men using this medication should ask about reliable forms of||
1354|154|P|birth control during treatment and for at least 3 months after||
1354|155|P|the last dose. If you or your partner becomes pregnant, talk to||
1354|156|P|your doctor right away about the risks and benefits of this||
1354|157|P|medication.||
1354|158|P|   It is unknown if this drug passes into breast milk. Because of||
1354|159|P|the possible risk to the infant, breastfeeding is not recommended||
1354|160|P|while using this drug and for at least 1 week after the last||
1354|161|P|dose. Consult your doctor before breastfeeding.||
1354|162|B|||
1354|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1354|164|I|medications work or increase your risk for serious side effects.||
1354|165|I|This document does not contain all possible drug interactions.||
1354|166|I|Keep a list of all the products you use (including||
1354|167|I|prescription/nonprescription drugs and herbal products) and share||
1354|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
1354|169|I|the dosage of any medicines without your doctor's approval.||
1354|170|I|   Some products that may interact with this drug include: "blood||
1354|171|I|thinners" (such as warfarin), valproic acid.||
1354|172|B|||
1354|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1354|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1354|175|O|poison control center right away. US residents can call||
1354|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1354|177|B|||
1354|178|N|NOTES:  Do not share this medication with others.||
1354|179|N|   Lab and/or medical tests (such as complete blood count, kidney||
1354|180|N|function, blood glucose levels, blood mineral levels including||
1354|181|N|potassium/magnesium/calcium) should be done while you are taking||
1354|182|N|this medication. Keep all medical and lab appointments. Consult||
1354|183|N|your doctor for more details.||
1354|184|B|||
1354|185|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1354|186|D|remember. If it is near the time of the next dose, skip the||
1354|187|D|missed dose. Take your next dose at the regular time. Do not||
1354|188|D|double the dose to catch up.||
1354|189|B|||
1354|190|R|STORAGE:  Store at room temperature away from light and moisture.||
1354|191|R|Do not store in the bathroom. Keep all medications away from||
1354|192|R|children and pets.||
1354|193|R|   Do not flush medications down the toilet or pour them into a||
1354|194|R|drain unless instructed to do so. Properly discard this product||
1354|195|R|when it is expired or no longer needed. Consult your pharmacist||
1354|196|R|or local waste disposal company.||
1354|197|B|||
1354|198|A|Information last revised October 2024.||
1354|199|A|Copyright(c) 2025 First Databank, Inc.||
1354|200|B|||
1355|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1355|002|Z|does NOT have all possible information about this product. This||
1355|003|Z|information does not assure that this product is safe, effective,||
1355|004|Z|or appropriate for you. This information is not individual||
1355|005|Z|medical advice and does not substitute for the advice of your||
1355|006|Z|health care professional. Always ask your health care||
1355|007|Z|professional for complete information about this product and your||
1355|008|Z|specific health needs.||
1355|009|B|||
1355|010|T|SALIVA SUBSTITUTE - MUCOUS MEMBRANE||
1355|011|B|||
1355|012|U|USES:  This medication is used to treat dry mouth and throat. It||
1355|013|U|is an artificial saliva that moistens and cleans the mouth. This||
1355|014|U|allows you to be more comfortable when drinking, chewing and||
1355|015|U|speaking. It also provides relief from mouth sores, also called||
1355|016|U|mucositis, caused by radiation treatment or cancer chemotherapy.||
1355|017|B|||
1355|018|H|HOW TO USE:  Follow all directions on the product package for||
1355|019|H|using this medication correctly. The dosage is based on your||
1355|020|H|medical condition and response to treatment. To relieve dry||
1355|021|H|mouth, use this medication as directed by your doctor by swishing||
1355|022|H|your prescribed dose in your mouth and then spitting it out. Do||
1355|023|H|not swallow this medication.||
1355|024|H|   If you are using the powder form of this medication, prepare||
1355|025|H|the medication as directed by the product package.||
1355|026|H|   If you are using this medication during radiation treatment or||
1355|027|H|cancer chemotherapy for mucositis, follow your doctor's||
1355|028|H|instructions carefully.||
1355|029|H|   Depending on your product, avoid eating or drinking for at||
1355|030|H|least 15 to 30 minutes after using this product. Read the product||
1355|031|H|instructions for more specific information.||
1355|032|H|   Use this medication regularly to get the most benefit from it.||
1355|033|H|To help you remember, use it at the same times each day.||
1355|034|H|   Tell your doctor if your condition lasts or gets worse.||
1355|035|B|||
1355|036|S|SIDE EFFECTS:  Saliva substitutes can be used with no side||
1355|037|S|effects. If you have any unusual side effects, tell your doctor||
1355|038|S|or pharmacist promptly.||
1355|039|S|   A very serious allergic reaction to this drug is rare.||
1355|040|S|However, get medical help right away if you notice any symptoms||
1355|041|S|of a serious allergic reaction, including: rash, itching/swelling||
1355|042|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1355|043|S|breathing.||
1355|044|S|   This is not a complete list of possible side effects. If you||
1355|045|S|notice other effects not listed above, contact your doctor or||
1355|046|S|pharmacist.||
1355|047|S|   In the US -||
1355|048|S|   Call your doctor for medical advice about side effects. You||
1355|049|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1355|050|S|www.fda.gov/medwatch.||
1355|051|S|   In Canada - Call your doctor for medical advice about side||
1355|052|S|effects. You may report side effects to Health Canada at||
1355|053|S|1-866-234-2345.||
1355|054|B|||
1355|055|P|PRECAUTIONS:  Before using saliva substitute, tell your doctor or||
1355|056|P|pharmacist if you are allergic to it; or if you have any other||
1355|057|P|allergies. This product may contain inactive ingredients, which||
1355|058|P|can cause allergic reactions or other problems. Talk to your||
1355|059|P|pharmacist for more details.||
1355|060|P|   Before using this medication, tell your doctor or pharmacist||
1355|061|P|your medical history.||
1355|062|P|   This medication may contain sodium. Before using this||
1355|063|P|medication, talk to your doctor if you are on a salt-restricted||
1355|064|P|diet or if increased salt intake could worsen your condition||
1355|065|P|(such as heart failure, high blood pressure).||
1355|066|P|   Tell your doctor if you are pregnant before using this||
1355|067|P|product.||
1355|068|P|   It is unknown if this drug passes into breast milk. Consult||
1355|069|P|your doctor before breastfeeding.||
1355|070|B|||
1355|071|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1355|072|I|medications work or increase your risk for serious side effects.||
1355|073|I|This document does not contain all possible drug interactions.||
1355|074|I|Keep a list of all the products you use (including||
1355|075|I|prescription/nonprescription drugs and herbal products) and share||
1355|076|I|it with your doctor and pharmacist. Do not start, stop, or change||
1355|077|I|the dosage of any medicines without your doctor's approval.||
1355|078|B|||
1355|079|O|OVERDOSE:  Overdose with this medication is unlikely even if||
1355|080|O|swallowed. However, if someone has overdosed and has serious||
1355|081|O|symptoms such as passing out or trouble breathing, call 911.||
1355|082|O|Otherwise, call a poison control center right away. US residents||
1355|083|O|can call 1-800-222-1222. Canada residents can call||
1355|084|O|1-844-764-7669.||
1355|085|B|||
1355|086|N|NOTES:  Do not share this medication with others.||
1355|087|B|||
1355|088|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1355|089|D|If it is near the time of the next dose, skip the missed dose.||
1355|090|D|Use your next dose at the regular time. Do not double the dose to||
1355|091|D|catch up.||
1355|092|B|||
1355|093|R|STORAGE:  Store at room temperature. Keep all medications away||
1355|094|R|from children and pets.||
1355|095|R|   Do not flush medications down the toilet or pour them into a||
1355|096|R|drain unless instructed to do so. Properly discard this product||
1355|097|R|when it is expired or no longer needed. Consult your pharmacist||
1355|098|R|or local waste disposal company.||
1355|099|B|||
1355|100|A|Information last revised January 2025.||
1355|101|A|Copyright(c) 2025 First Databank, Inc.||
1355|102|B|||
1356|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1356|002|Z|does NOT have all possible information about this product. This||
1356|003|Z|information does not assure that this product is safe, effective,||
1356|004|Z|or appropriate for you. This information is not individual||
1356|005|Z|medical advice and does not substitute for the advice of your||
1356|006|Z|health care professional. Always ask your health care||
1356|007|Z|professional for complete information about this product and your||
1356|008|Z|specific health needs.||
1356|009|B|||
1356|010|T|BUPRENORPHINE/NALOXONE FILM - SUBLINGUAL||
1356|011|F|(BUE-pre-NOR-feen/nal-OX-one)||
1356|012|B|||
1356|013|C|COMMON BRAND NAME(S): Suboxone||
1356|014|B|||
1356|015|U|USES:  This medication contains 2 medicines: buprenorphine and||
1356|016|U|naloxone. It is used to treat opioid use disorder. Buprenorphine||
1356|017|U|belongs to a class of drugs called mixed opioid||
1356|018|U|agonist-antagonists. Buprenorphine helps prevent withdrawal||
1356|019|U|symptoms caused by stopping other opioids.||
1356|020|U|   Naloxone is an opioid antagonist that blocks the effect of||
1356|021|U|opioids and can cause severe opioid withdrawal when injected.||
1356|022|U|Withdrawal is less likely when naloxone is taken by mouth,||
1356|023|U|dissolved under the tongue, or dissolved on the inside of the||
1356|024|U|cheek. It is combined with buprenorphine to prevent abuse and||
1356|025|U|misuse (injection) of this medication. This combination||
1356|026|U|medication is used as part of a complete treatment program for||
1356|027|U|opioid use disorder (such as compliance monitoring, counseling,||
1356|028|U|behavioral contract, lifestyle changes).||
1356|029|U|   Ask your doctor or pharmacist if you should have medication||
1356|030|U|available to treat opioid overdose (such as nalmefene, other||
1356|031|U|forms of naloxone). Teach your family or household members about||
1356|032|U|the signs of an opioid overdose and how to treat it.||
1356|033|B|||
1356|034|H|HOW TO USE:  Read the Medication Guide provided by your||
1356|035|H|pharmacist before you start using this medication and each time||
1356|036|H|you get a refill. This medication can either be dissolved under||
1356|037|H|the tongue or dissolved on the inside of the cheek. Follow your||
1356|038|H|doctor's directions. Learn how to correctly use this medication.||
1356|039|H|If you have any questions, ask your doctor or pharmacist.||
1356|040|H|   Use this medication as directed by your doctor, usually once||
1356|041|H|daily. Drink some water to moisten your mouth before use. This||
1356|042|H|helps the film dissolve. With dry hands, open the foil packet||
1356|043|H|just before use and place the medication film under your tongue||
1356|044|H|or inside your cheek. Keep the film in place until it completely||
1356|045|H|dissolves. Do not talk, swallow, chew, or move the film after||
1356|046|H|placing it under your tongue or on the inside of your cheek, or||
1356|047|H|it will not work as well.||
1356|048|H|   If you are prescribed more than one film each day, place the||
1356|049|H|second film under your tongue on the opposite side of the mouth||
1356|050|H|or on the inside of the other cheek. Try not to have the films||
1356|051|H|touch each other. If your doctor has prescribed a third film,||
1356|052|H|place it under your tongue or on the inside of either cheek after||
1356|053|H|the first 2 films have completely dissolved.||
1356|054|H|   After the medication is fully dissolved, take a large sip of||
1356|055|H|water and swish gently around your teeth and gums, and then||
1356|056|H|swallow the water. This will help to prevent problems with your||
1356|057|H|teeth. Do not brush your teeth for at least one hour after using||
1356|058|H|this medication.||
1356|059|H|   Buprenorphine alone may be used instead of this medication for||
1356|060|H|the first 2 days after you have stopped all other opioids. It is||
1356|061|H|usually given in your doctor's office. Your doctor will then||
1356|062|H|switch you to this combination buprenorphine/naloxone medication||
1356|063|H|for maintenance treatment.||
1356|064|H|   The dosage is based on your medical condition and response to||
1356|065|H|treatment. Your doctor will adjust the dose until there are no||
1356|066|H|symptoms of withdrawal. Do not switch between sublingual tablets||
1356|067|H|and film, because you may need a different dose if you switch. Do||
1356|068|H|not increase your dose or use this drug more often or for longer||
1356|069|H|than prescribed. Properly stop the medication when directed.||
1356|070|H|   Use this medication regularly to get the most benefit from it.||
1356|071|H|To help you remember, use it at the same time each day.||
1356|072|H|   If you suddenly stop using this medication, you may have||
1356|073|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
1356|074|H|nose, nausea, sweating, muscle aches). To help prevent||
1356|075|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1356|076|H|more likely if you have used this medication for a long time or||
1356|077|H|in high doses. Tell your doctor or pharmacist right away if you||
1356|078|H|have withdrawal.||
1356|079|H|   Do not inject ("shoot up") buprenorphine/naloxone. Injecting||
1356|080|H|it is dangerous, and will likely cause severe withdrawal symptoms||
1356|081|H|due to the naloxone in this medication, especially if you have||
1356|082|H|been using opioids such as heroin, morphine or methadone.||
1356|083|H|   Keep this medicine in a safe place to prevent theft, misuse,||
1356|084|H|or abuse. If a child accidentally swallows this drug, get medical||
1356|085|H|help right away.||
1356|086|B|||
1356|087|S|SIDE EFFECTS:  Nausea, vomiting, drowsiness, dizziness,||
1356|088|S|constipation, or headache may occur. If any of these effects last||
1356|089|S|or get worse, tell your doctor or pharmacist promptly.||
1356|090|S|   To prevent constipation, eat dietary fiber, drink enough||
1356|091|S|water, and exercise. You may also need to take a laxative. Ask||
1356|092|S|your pharmacist which type of laxative is right for you.||
1356|093|S|   To reduce the risk of dizziness and lightheadedness, get up||
1356|094|S|slowly when rising from a sitting or lying position.||
1356|095|S|   Remember that this medication has been prescribed because your||
1356|096|S|doctor has judged that the benefit to you is greater than the||
1356|097|S|risk of side effects. Many people using this medication do not||
1356|098|S|have serious side effects.||
1356|099|S|   Although this medication is used to prevent withdrawal||
1356|100|S|reactions, it may rarely cause opioid withdrawal symptoms (see||
1356|101|S|also How to Use section). This is more likely to happen when you||
1356|102|S|first start treatment or if you have been using long-acting||
1356|103|S|opioids such as methadone. If such symptoms occur, tell your||
1356|104|S|doctor or pharmacist right away.||
1356|105|S|   Severe (possibly fatal) breathing problems can occur,||
1356|106|S|especially if this medication is abused, injected, or mixed with||
1356|107|S|other depressants (such as alcohol, benzodiazepines including||
1356|108|S|diazepam, other opioids).||
1356|109|S|   Tell your doctor right away if you have any serious side||
1356|110|S|effects, including: interrupted breathing during sleep (sleep||
1356|111|S|apnea), tooth/gum pain, signs of your adrenal glands not working||
1356|112|S|well (such as unusual tiredness, weight loss), trouble||
1356|113|S|swallowing.||
1356|114|S|   Get medical help right away if you have any very serious side||
1356|115|S|effects, including: fainting, fast/irregular heartbeat, severe||
1356|116|S|dizziness, mental/mood changes (such as agitation, confusion,||
1356|117|S|hallucinations), slow/shallow breathing, unusual||
1356|118|S|drowsiness/difficulty waking up.||
1356|119|S|   This drug may rarely cause serious (possibly fatal) liver||
1356|120|S|disease. Get medical help right away if you have any symptoms of||
1356|121|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1356|122|S|of appetite, dark urine, severe stomach/abdominal pain, yellowing||
1356|123|S|eyes/skin.||
1356|124|S|   A very serious allergic reaction to this drug is rare.||
1356|125|S|However, get medical help right away if you notice any symptoms||
1356|126|S|of a serious allergic reaction, including: rash, itching/swelling||
1356|127|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1356|128|S|breathing.||
1356|129|S|   This is not a complete list of possible side effects. If you||
1356|130|S|notice other effects not listed above, contact your doctor or||
1356|131|S|pharmacist.||
1356|132|S|   In the US -||
1356|133|S|   Call your doctor for medical advice about side effects. You||
1356|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1356|135|S|www.fda.gov/medwatch.||
1356|136|S|   In Canada - Call your doctor for medical advice about side||
1356|137|S|effects. You may report side effects to Health Canada at||
1356|138|S|1-866-234-2345.||
1356|139|B|||
1356|140|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1356|141|P|pharmacist if you are allergic to buprenorphine or naloxone; or||
1356|142|P|if you have any other allergies. This product may contain||
1356|143|P|inactive ingredients, which can cause allergic reactions or other||
1356|144|P|problems. Talk to your pharmacist for more details.||
1356|145|P|   Before using this medication, tell your doctor or pharmacist||
1356|146|P|your medical history, especially of: brain disorders (such as||
1356|147|P|head injury, tumor, seizures), breathing problems (such as||
1356|148|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1356|149|P|liver disease, mental/mood disorders (such as confusion,||
1356|150|P|depression, thoughts of suicide), stomach/intestinal problems||
1356|151|P|(such as blockage, constipation, diarrhea due to infection,||
1356|152|P|paralytic ileus), difficulty urinating (such as due to enlarged||
1356|153|P|prostate).||
1356|154|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1356|155|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1356|156|P|machinery, or do anything that needs alertness until you can do||
1356|157|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1356|158|P|are using marijuana (cannabis). Alcohol increases your risk for||
1356|159|P|serious, possibly fatal, breathing problems.||
1356|160|P|   Buprenorphine may cause a condition that affects the heart||
1356|161|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1356|162|P|serious (rarely fatal) fast/irregular heartbeat and other||
1356|163|P|symptoms (such as severe dizziness, fainting) that need medical||
1356|164|P|attention right away.||
1356|165|P|   The risk of QT prolongation may be increased if you have||
1356|166|P|certain medical conditions or are taking other drugs that may||
1356|167|P|cause QT prolongation. Before using buprenorphine, tell your||
1356|168|P|doctor or pharmacist of all the drugs you take and if you have||
1356|169|P|any of the following conditions: certain heart problems (heart||
1356|170|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1356|171|P|history of certain heart problems (QT prolongation in the EKG,||
1356|172|P|sudden cardiac death).||
1356|173|P|   Low levels of potassium or magnesium in the blood may also||
1356|174|P|increase your risk of QT prolongation. This risk may increase if||
1356|175|P|you use certain drugs (such as diuretics/"water pills") or if you||
1356|176|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1356|177|P|Talk to your doctor about using buprenorphine safely.||
1356|178|P|   Some people using this medication may have dental problems||
1356|179|P|(such as tooth decay/loss, cavities, infection). Schedule a visit||
1356|180|P|to the dentist soon after starting this medication and tell your||
1356|181|P|dentist that you are using this medication. To help prevent||
1356|182|P|dental problems, have regular dental exams and learn how to keep||
1356|183|P|your teeth and gums healthy. If you have tooth or gum pain, tell||
1356|184|P|your doctor and dentist right away.||
1356|185|P|   Before having surgery, tell your doctor or dentist about all||
1356|186|P|the products you use (including prescription drugs,||
1356|187|P|nonprescription drugs, and herbal products).||
1356|188|P|   Older adults may be more sensitive to the side effects of this||
1356|189|P|drug, especially drowsiness, slow/shallow breathing, and QT||
1356|190|P|prolongation (see above).||
1356|191|P|   Before using this medication, women of childbearing age should||
1356|192|P|talk with their doctor(s) about the risks and benefits. Tell your||
1356|193|P|doctor if you are pregnant or if you plan to become pregnant.||
1356|194|P|During pregnancy, this medication should be used only when||
1356|195|P|clearly needed. It may slightly increase the risk of birth||
1356|196|P|defects if used during the first two months of pregnancy. Also,||
1356|197|P|using it for a long time or in high doses near the expected||
1356|198|P|delivery date may harm the unborn baby. To lessen the risk, use||
1356|199|P|the smallest effective dose for the shortest possible time. Tell||
1356|200|P|the doctor right away if you notice any symptoms in your newborn||
1356|201|P|baby such as abnormal/nonstop crying, slow/shallow breathing,||
1356|202|P|irritability, vomiting, or diarrhea.||
1356|203|P|   Buprenorphine passes into breast milk. It is unknown if||
1356|204|P|naloxone passes into breast milk. This product may rarely have||
1356|205|P|undesirable effects on a nursing infant. Tell the doctor right||
1356|206|P|away if your baby develops unusual sleepiness, difficulty||
1356|207|P|feeding, or trouble breathing. Consult your doctor before||
1356|208|P|breastfeeding.||
1356|209|B|||
1356|210|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1356|211|I|medications work or increase your risk for serious side effects.||
1356|212|I|This document does not contain all possible drug interactions.||
1356|213|I|Keep a list of all the products you use (including||
1356|214|I|prescription/nonprescription drugs and herbal products) and share||
1356|215|I|it with your doctor and pharmacist. Do not start, stop, or change||
1356|216|I|the dosage of any medicines without your doctor's approval.||
1356|217|I|   Some products that may interact with this medication include:||
1356|218|I|certain pain medications (mixed opioid agonist-antagonists such||
1356|219|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1356|220|I|samidorphan.||
1356|221|I|   The risk of serious side effects (such as slow/shallow||
1356|222|I|breathing, severe drowsiness/dizziness) may be increased if this||
1356|223|I|medication is used with other products that may also affect||
1356|224|I|breathing or cause drowsiness. Tell your doctor or pharmacist if||
1356|225|I|you are taking other products such as alcohol, marijuana||
1356|226|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1356|227|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1356|228|I|zolpidem), muscle relaxants (such as carisoprodol,||
1356|229|I|cyclobenzaprine), and other opioid pain relievers (such as||
1356|230|I|codeine, hydrocodone).||
1356|231|I|   Check the labels on all your medicines (such as allergy or||
1356|232|I|cough-and-cold products) because they may contain ingredients||
1356|233|I|that cause drowsiness. Ask your pharmacist about using those||
1356|234|I|products safely.||
1356|235|I|   Deaths have occurred when this medication has been misused by||
1356|236|I|injecting it ("shooting up"), especially when used in combination||
1356|237|I|with benzodiazepines (such as diazepam) or other depressants such||
1356|238|I|as alcohol or additional opioids.||
1356|239|B|||
1356|240|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1356|241|O|as passing out or trouble breathing, give them naloxone if||
1356|242|O|available, then call 911. If the person is awake and has no||
1356|243|O|symptoms, call a poison control center right away. US residents||
1356|244|O|can call 1-800-222-1222. Canada residents can call||
1356|245|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1356|246|O|breathing, slow heartbeat, coma.||
1356|247|B|||
1356|248|N|NOTES:  Do not share this medication with others. Sharing it is||
1356|249|N|against the law.||
1356|250|N|   Tell all of your doctors that you use this medication and have||
1356|251|N|regularly used opioids, especially in cases of emergency||
1356|252|N|treatment.||
1356|253|N|   Lab and/or medical tests (such as liver function, urine drug||
1356|254|N|screening) should be done while you are using this medication.||
1356|255|N|Keep all medical and lab appointments. Consult your doctor for||
1356|256|N|more details.||
1356|257|B|||
1356|258|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1356|259|D|remember. If it is near the time of the next dose, skip the||
1356|260|D|missed dose. Take your next dose at the regular time. Do not||
1356|261|D|double the dose to catch up.||
1356|262|B|||
1356|263|R|STORAGE:  Store in a secure place at room temperature away from||
1356|264|R|light and moisture. Do not store in the bathroom. Keep all||
1356|265|R|medications away from children and pets.||
1356|266|R|   Do not flush medications down the toilet or pour them into a||
1356|267|R|drain unless instructed to do so. Properly discard this product||
1356|268|R|when it is expired or no longer needed. For more details, read||
1356|269|R|the Medication Guide, or consult your pharmacist or local waste||
1356|270|R|disposal company.||
1356|271|B|||
1356|272|A|Information last revised August 2025.||
1356|273|A|Copyright(c) 2025 First Databank, Inc.||
1356|274|B|||
1357|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1357|002|Z|does NOT have all possible information about this product. This||
1357|003|Z|information does not assure that this product is safe, effective,||
1357|004|Z|or appropriate for you. This information is not individual||
1357|005|Z|medical advice and does not substitute for the advice of your||
1357|006|Z|health care professional. Always ask your health care||
1357|007|Z|professional for complete information about this product and your||
1357|008|Z|specific health needs.||
1357|009|B|||
1357|010|T|TRABECTEDIN - INJECTION||
1357|011|F|(tra-BEK-te-din)||
1357|012|B|||
1357|013|C|COMMON BRAND NAME(S): Yondelis||
1357|014|B|||
1357|015|W|WARNING:  Trabectedin may cause serious infection and injection||
1357|016|W|site/liver/muscle/lung problems. It should not be used by people||
1357|017|W|with liver problems (such as active hepatitis, increased||
1357|018|W|bilirubin levels). Your doctor will order blood tests to monitor||
1357|019|W|for problems before starting and during treatment with this||
1357|020|W|medication. See also Side Effects section.||
1357|021|B|||
1357|022|U|USES:  Trabectedin is used to treat certain types of cancer. It||
1357|023|U|is a chemotherapy drug that works by slowing the growth of cancer||
1357|024|U|cells.||
1357|025|B|||
1357|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1357|027|H|from your pharmacist before you start using trabectedin and||
1357|028|H|before each treatment. If you have any questions, ask your doctor||
1357|029|H|or pharmacist.||
1357|030|H|   This medication is given by injection into a large vein||
1357|031|H|(central line) by a health care professional. It is usually given||
1357|032|H|every 3 weeks.||
1357|033|H|   Your doctor will order a corticosteroid (such as||
1357|034|H|dexamethasone) to lower the risk of liver problems or prevent||
1357|035|H|side effects such as nausea/vomiting. These medications are||
1357|036|H|usually given at least 30 minutes before your dose of||
1357|037|H|trabectedin.||
1357|038|H|   The dosage is based on your height, weight, medical condition,||
1357|039|H|lab test results, and response to treatment.||
1357|040|B|||
1357|041|S|SIDE EFFECTS:  Headache, weakness, tiredness, constipation,||
1357|042|S|diarrhea, body aches, skin darkening, or trouble sleeping may||
1357|043|S|occur. If any of these effects last or get worse, tell your||
1357|044|S|doctor or pharmacist promptly.||
1357|045|S|   Nausea and vomiting can also occur and may be severe. Tell||
1357|046|S|your doctor right away if these effects occur. In some cases,||
1357|047|S|your doctor may prescribe medication to prevent or relieve nausea||
1357|048|S|and vomiting. Eating several small meals, not eating before||
1357|049|S|treatment, or limiting activity may help to lessen the nausea and||
1357|050|S|vomiting.||
1357|051|S|   Many people using this medication may have serious side||
1357|052|S|effects. However, you have been prescribed this drug because your||
1357|053|S|doctor has judged that the benefit to you is greater than the||
1357|054|S|risk of side effects. Careful monitoring by your doctor may||
1357|055|S|decrease your risk.||
1357|056|S|   Trabectedin may cause serious injury at the injection site.||
1357|057|S|Tell your health care professional right away if you experience||
1357|058|S|pain, irritation, redness, or swelling at the injection site.||
1357|059|S|Prompt treatment will help reduce discomfort and possible skin||
1357|060|S|damage.||
1357|061|S|   Trabectedin decreases bone marrow function, an effect that may||
1357|062|S|lead to a low number of blood cells such as red cells, white||
1357|063|S|cells, and platelets. Your doctor will monitor you closely and||
1357|064|S|check your blood often during treatment. You may also receive||
1357|065|S|another medication to reduce the risk of this side effect. If||
1357|066|S|your blood cell count is too low, you should not receive||
1357|067|S|trabectedin. Tell your doctor right away if you develop any of||
1357|068|S|the following symptoms: unusual tiredness, pale skin, signs of||
1357|069|S|infection (such as sore throat that doesn't go away, fever,||
1357|070|S|chills), easy bruising/bleeding.||
1357|071|S|   This medication may cause liver problems. Alcohol can increase||
1357|072|S|the risk of liver problems. Do not drink alcoholic beverages.||
1357|073|S|Your doctor will order blood tests to check for liver problems.||
1357|074|S|Tell your doctor right away if you notice any of the following||
1357|075|S|serious side effects: nausea/vomiting that doesn't stop,||
1357|076|S|yellowing eyes/skin, dark urine, severe stomach/abdominal pain.||
1357|077|S|   This drug may rarely cause serious muscle problems||
1357|078|S|(rhabdomyolysis). Tell your doctor right away if you develop any||
1357|079|S|of these symptoms: muscle pain/tenderness/weakness, signs of||
1357|080|S|kidney problems (such as change in the amount of urine).||
1357|081|S|   This medication may rarely cause a blood clot in the lungs||
1357|082|S|(pulmonary embolism) or serious heart problems. Get medical help||
1357|083|S|right away if you have: chest pain, trouble breathing, coughing||
1357|084|S|up blood, swelling ankles/feet, sudden unexplained weight gain,||
1357|085|S|severe tiredness, fast heartbeat.||
1357|086|S|   This medication may rarely cause a serious condition||
1357|087|S|(capillary leak syndrome), that can sometimes be fatal. Get||
1357|088|S|medical help right away if you develop symptoms, including:||
1357|089|S|sudden swelling, shortness of breath, signs of kidney problems||
1357|090|S|(such as passing less urine), severe dizziness.||
1357|091|S|   A very serious allergic reaction to this drug is rare.||
1357|092|S|However, get medical help right away if you notice any symptoms||
1357|093|S|of a serious allergic reaction, including: rash, itching/swelling||
1357|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1357|095|S|breathing.||
1357|096|S|   This is not a complete list of possible side effects. If you||
1357|097|S|notice other effects not listed above, contact your doctor or||
1357|098|S|pharmacist.||
1357|099|S|   In the US -||
1357|100|S|   Call your doctor for medical advice about side effects. You||
1357|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1357|102|S|www.fda.gov/medwatch.||
1357|103|S|   In Canada - Call your doctor for medical advice about side||
1357|104|S|effects. You may report side effects to Health Canada at||
1357|105|S|1-866-234-2345.||
1357|106|B|||
1357|107|P|PRECAUTIONS:  Before receiving trabectedin, tell your doctor or||
1357|108|P|pharmacist if you are allergic to it; or if you have any other||
1357|109|P|allergies. This product may contain other inactive ingredients,||
1357|110|P|which can cause allergic reactions or other problems. Talk to||
1357|111|P|your pharmacist for more details.||
1357|112|P|   Before using this medication, tell your doctor or pharmacist||
1357|113|P|your medical history, especially of: low blood cell counts, liver||
1357|114|P|disease (such as active hepatitis), kidney disease,||
1357|115|P|recent/current infections, heart disease (such as heart failure).||
1357|116|P|   This drug may make you feel tired or weak. Alcohol or||
1357|117|P|marijuana (cannabis) can make you more tired. Do not drive, use||
1357|118|P|machinery, or do anything that needs alertness until you can do||
1357|119|P|it safely. Avoid alcoholic beverages. Alcohol can increase the||
1357|120|P|risk of liver problems. Talk to your doctor if you are using||
1357|121|P|marijuana (cannabis). .||
1357|122|P|   Trabectedin can make you more likely to get infections or may||
1357|123|P|make current infections worse. Stay away from anyone who has an||
1357|124|P|infection that may easily spread (such as chickenpox, COVID-19,||
1357|125|P|measles, flu). Talk to your doctor if you have been exposed to an||
1357|126|P|infection or for more details.||
1357|127|P|   Tell your health care professional that you are using||
1357|128|P|trabectedin before having any immunizations/vaccinations. Avoid||
1357|129|P|contact with people who have recently received live vaccines||
1357|130|P|(such as flu vaccine inhaled through the nose).||
1357|131|P|   To lower the chance of getting cut, bruised, or injured, use||
1357|132|P|caution with sharp objects like razors and nail cutters, and||
1357|133|P|avoid activities such as contact sports.||
1357|134|P|   Before having surgery, tell your doctor or dentist about all||
1357|135|P|the products you use (including prescription drugs,||
1357|136|P|nonprescription drugs, and herbal products).||
1357|137|P|   Older adults may be at greater risk for heart problems while||
1357|138|P|using this drug.||
1357|139|P|   This medication may damage sperm in men. For both men and||
1357|140|P|women using this medication, trabectedin may decrease the ability||
1357|141|P|to have children in the future. Consult your doctor for more||
1357|142|P|details.||
1357|143|P|   This medication must not be used during pregnancy. It may harm||
1357|144|P|an unborn baby. If you become pregnant or think you may be||
1357|145|P|pregnant, or if your partner becomes pregnant, tell your doctor||
1357|146|P|right away. To avoid pregnancy, both men and women receiving this||
1357|147|P|drug should use reliable form(s) of birth control (such as birth||
1357|148|P|control pills, condoms) during treatment, and for 3 months after||
1357|149|P|treatment for women, and for 5 months after treatment for men.||
1357|150|P|Consult your doctor for details and to discuss effective forms of||
1357|151|P|birth control.||
1357|152|P|   It is unknown if this drug passes into breast milk. Do not||
1357|153|P|breastfeed while using this drug and for 3 months after||
1357|154|P|treatment.||
1357|155|B|||
1357|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1357|157|I|medications work or increase your risk for serious side effects.||
1357|158|I|This document does not contain all possible drug interactions.||
1357|159|I|Keep a list of all the products you use (including||
1357|160|I|prescription/nonprescription drugs and herbal products) and share||
1357|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
1357|162|I|the dosage of any medicines without your doctor's approval.||
1357|163|I|   Some products that may interact with this drug include:||
1357|164|I|"statins" (such as atorvastatin, simvastatin).||
1357|165|I|   Other medications can affect the removal of trabectedin from||
1357|166|I|your body, thereby affecting how trabectedin works. These drugs||
1357|167|I|include azole antifungals (such as fluconazole, ketoconazole),||
1357|168|I|macrolide antibiotics (such as clarithromycin), HIV drugs (such||
1357|169|I|as nelfinavir), rifamycins (such as rifabutin), ritonavir, St.||
1357|170|I|John's wort, and some drugs used to treat seizures (such as||
1357|171|I|carbamazepine, phenobarbital, primidone), among others.||
1357|172|B|||
1357|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1357|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1357|175|O|poison control center right away. US residents can call||
1357|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1357|177|B|||
1357|178|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1357|179|N|kidney/liver/heart/muscle function) must be done before and while||
1357|180|N|you are using this medication. Keep all medical and lab||
1357|181|N|appointments.||
1357|182|B|||
1357|183|D|MISSED DOSE:  It is important to get each dose of this medication||
1357|184|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1357|185|D|right away for a new dosing schedule.||
1357|186|B|||
1357|187|R|STORAGE:  Not applicable. This medication is given in a hospital||
1357|188|R|and will not be stored at home.||
1357|189|B|||
1357|190|A|Information last revised May 2024.||
1357|191|A|Copyright(c) 2025 First Databank, Inc.||
1357|192|B|||
1359|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1359|002|Z|does NOT have all possible information about this product. This||
1359|003|Z|information does not assure that this product is safe, effective,||
1359|004|Z|or appropriate for you. This information is not individual||
1359|005|Z|medical advice and does not substitute for the advice of your||
1359|006|Z|health care professional. Always ask your health care||
1359|007|Z|professional for complete information about this product and your||
1359|008|Z|specific health needs.||
1359|009|B|||
1359|010|T|SODIUM/POTASSIUM/MAGNESIUM SULFATE SOLUTION - ORAL||
1359|011|F|(SOE-dee-um/poh-TASS-ee-um/mag-NEE-zee-um/SUL-fate)||
1359|012|B|||
1359|013|C|COMMON BRAND NAME(S): Suprep||
1359|014|B|||
1359|015|U|USES:  Sodium/potassium/magnesium sulfate solution is used to||
1359|016|U|clean out the intestines before a certain bowel exam procedure||
1359|017|U|(colonoscopy). It is a laxative that works by drawing large||
1359|018|U|amounts of water into the colon. This causes watery bowel||
1359|019|U|movements. Clearing stool from the intestines helps your doctor||
1359|020|U|to better examine the intestines during your procedure.||
1359|021|B|||
1359|022|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1359|023|H|provided by your pharmacist before you start using this product||
1359|024|H|and each time you get a refill. If you have any questions, ask||
1359|025|H|your doctor or pharmacist.||
1359|026|H|   Follow any special diet instructions provided by your doctor.||
1359|027|H|Usually, you may have a small breakfast or only clear liquids on||
1359|028|H|the day before your procedure. After breakfast, you may only||
1359|029|H|drink clear liquids until after your procedure. Do not drink milk||
1359|030|H|or alcoholic beverages or eat/drink anything colored red or||
1359|031|H|purple. To prevent becoming dehydrated, drink as much clear||
1359|032|H|liquid as you can before, during, and after drinking this||
1359|033|H|medication unless otherwise directed by your doctor.||
1359|034|H|   Do not take any other medications by mouth within 1 hour of||
1359|035|H|starting to drink the mixture. Ask your doctor or pharmacist if||
1359|036|H|you are not sure when to take your other medications.||
1359|037|H|   Use this product as directed by your doctor, usually one dose||
1359|038|H|the evening before the colonoscopy and the second dose the next||
1359|039|H|day in the morning. The dosage is based on your age and medical||
1359|040|H|condition.||
1359|041|H|   Before using this product, pour the contents into the mixing||
1359|042|H|container as directed by the manufacturer. Add cool water, mix,||
1359|043|H|and drink all of the mixture. After drinking the mixture, drink 2||
1359|044|H|additional containers filled with water over the next hour. Be||
1359|045|H|sure to finish drinking all of the mixture and required water at||
1359|046|H|least 2 hours before your procedure, or as directed.||
1359|047|H|   Ask your doctor or pharmacist if you have any questions about||
1359|048|H|how to mix or take this product or what to expect after taking||
1359|049|H|this product.||
1359|050|H|   Watery bowel movements usually begin about 1 hour after you||
1359|051|H|drink the mixed liquid. The bowel movements can be very large and||
1359|052|H|watery.||
1359|053|B|||
1359|054|S|SIDE EFFECTS:  Very watery bowel movements are expected with this||
1359|055|S|medication. Nausea, vomiting, bloating, or stomach/abdominal||
1359|056|S|cramping may occur. If any of these effects last or get worse,||
1359|057|S|tell your doctor or pharmacist promptly.||
1359|058|S|   Remember that this medication has been prescribed because your||
1359|059|S|doctor has judged that the benefit to you is greater than the||
1359|060|S|risk of side effects. Many people using this medication do not||
1359|061|S|have serious side effects.||
1359|062|S|   This medication can cause your body to lose too much fluid and||
1359|063|S|salts (dehydration, electrolyte problems). Tell your doctor right||
1359|064|S|away if you have any of these serious side effects: severe||
1359|065|S|dizziness, fainting, fast/irregular heartbeat, trouble keeping||
1359|066|S|liquids down, prolonged vomiting, headache, seizure.||
1359|067|S|   Tell your doctor right away if you have any serious side||
1359|068|S|effects, including: stomach/abdominal pain that is severe or||
1359|069|S|doesn't go away, signs of kidney problems (such as change in the||
1359|070|S|amount of urine), bloody stools, rectal bleeding.||
1359|071|S|   A very serious allergic reaction to this drug is rare.||
1359|072|S|However, get medical help right away if you notice any symptoms||
1359|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1359|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1359|075|S|breathing.||
1359|076|S|   This is not a complete list of possible side effects. If you||
1359|077|S|notice other effects not listed above, contact your doctor or||
1359|078|S|pharmacist.||
1359|079|S|   In the US -||
1359|080|S|   Call your doctor for medical advice about side effects. You||
1359|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1359|082|S|www.fda.gov/medwatch.||
1359|083|S|   In Canada - Call your doctor for medical advice about side||
1359|084|S|effects. You may report side effects to Health Canada at||
1359|085|S|1-866-234-2345.||
1359|086|B|||
1359|087|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1359|088|P|pharmacist if you have any allergies. This product may contain||
1359|089|P|inactive ingredients, which can cause allergic reactions or other||
1359|090|P|problems. Talk to your pharmacist for more details.||
1359|091|P|   Before using this medication, tell your doctor or pharmacist||
1359|092|P|your medical history, especially of: blocked intestines||
1359|093|P|(gastrointestinal obstruction), hole in the intestines, severe||
1359|094|P|ulcers/swelling of the colon (ulcerative colitis), severe||
1359|095|P|infection in the intestines (such as toxic colitis, toxic||
1359|096|P|megacolon), stomach/intestines that empty slowly or are not||
1359|097|P|moving (gastric retention, ileus), trouble swallowing, trouble||
1359|098|P|keeping food down (regurgitation), history of breathing||
1359|099|P|food/other substances into the lungs (aspiration), gout, heart||
1359|100|P|problems (such as irregular heartbeat, chest pain, heart||
1359|101|P|failure), kidney problems, seizure, regular use of alcohol or||
1359|102|P|other sedatives.||
1359|103|P|   Before having surgery, tell your doctor or dentist about all||
1359|104|P|the products you use (including prescription drugs,||
1359|105|P|nonprescription drugs, and herbal products).||
1359|106|P|   During pregnancy, this medication should be used only when||
1359|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
1359|108|P|   It is unknown if this drug passes into breast milk. Consult||
1359|109|P|your doctor before breastfeeding.||
1359|110|B|||
1359|111|I|DRUG INTERACTIONS:  See also How to Use section.||
1359|112|I|   Drug interactions may change how your medications work or||
1359|113|I|increase your risk for serious side effects. This document does||
1359|114|I|not contain all possible drug interactions. Keep a list of all||
1359|115|I|the products you use (including prescription/nonprescription||
1359|116|I|drugs and herbal products) and share it with your doctor and||
1359|117|I|pharmacist. Do not start, stop, or change the dosage of any||
1359|118|I|medicines without your doctor's approval.||
1359|119|I|   Some products that may interact with this drug include drugs||
1359|120|I|that can change the amount of water, sodium, or potassium in your||
1359|121|I|body, such as: heart/blood pressure medications called ARBs (such||
1359|122|I|as valsartan), heart/blood pressure medications called ACE||
1359|123|I|inhibitors (such as captopril, enalapril), nonsteroidal||
1359|124|I|anti-inflammatory drugs - NSAIDs (such as ibuprofen, naproxen),||
1359|125|I|"water pills" such as thiazide diuretics.||
1359|126|I|   Do not take/use other laxatives while taking this product.||
1359|127|B|||
1359|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1359|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1359|130|O|poison control center right away. US residents can call||
1359|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1359|132|B|||
1359|133|N|NOTES:  Do not share this medication with others.||
1359|134|N|   Lab tests (such as sodium, potassium levels) may be done||
1359|135|N|before or after taking this medication. Keep all medical and lab||
1359|136|N|appointments. Consult your doctor for more details.||
1359|137|B|||
1359|138|D|MISSED DOSE:  If you are unable to drink all of the solution and||
1359|139|D|water as directed, call your doctor right away. Your test may||
1359|140|D|need to be rescheduled.||
1359|141|B|||
1359|142|R|STORAGE:  Store the unmixed container at room temperature. Keep||
1359|143|R|all medications away from children and pets.||
1359|144|R|   Do not flush medications down the toilet or pour them into a||
1359|145|R|drain unless instructed to do so. Properly discard this product||
1359|146|R|when it is expired or no longer needed. Consult your pharmacist||
1359|147|R|or local waste disposal company.||
1359|148|B|||
1359|149|A|Information last revised October 2024.||
1359|150|A|Copyright(c) 2025 First Databank, Inc.||
1359|151|B|||
1360|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1360|002|Z|does NOT have all possible information about this product. This||
1360|003|Z|information does not assure that this product is safe, effective,||
1360|004|Z|or appropriate for you. This information is not individual||
1360|005|Z|medical advice and does not substitute for the advice of your||
1360|006|Z|health care professional. Always ask your health care||
1360|007|Z|professional for complete information about this product and your||
1360|008|Z|specific health needs.||
1360|009|B|||
1360|010|T|OXYCODONE/NALOXONE SUSTAINED-ACTION - ORAL||
1360|011|F|(oxy-CODE-own/nal-OX-one)||
1360|012|B|||
1360|013|W|WARNING:  Oxycodone has a risk for abuse and addiction, which can||
1360|014|W|lead to overdose and death. Oxycodone may also cause severe,||
1360|015|W|possibly fatal, breathing problems. To lower your risk, your||
1360|016|W|doctor should have you take the smallest dose of oxycodone that||
1360|017|W|works, and take it for the shortest possible time. See also How||
1360|018|W|to Use section for more information about addiction.||
1360|019|W|   Ask your doctor or pharmacist if you should have medication||
1360|020|W|available to treat opioid overdose (such as nalmefene, other||
1360|021|W|forms of naloxone). Teach your family or household members about||
1360|022|W|the signs of an opioid overdose and how to treat it.||
1360|023|W|   The risk for severe breathing problems is higher when you||
1360|024|W|start this medication and after a dose increase, or if you take||
1360|025|W|the wrong dose/strength. Taking this medication with alcohol or||
1360|026|W|other drugs that can cause drowsiness or breathing problems may||
1360|027|W|cause very serious side effects, including death. Also, other||
1360|028|W|medications can affect the removal of oxycodone from your body,||
1360|029|W|which may affect how oxycodone works. Be sure you know how to||
1360|030|W|take oxycodone/naloxone and what other drugs you should avoid||
1360|031|W|taking with it. See also Drug Interactions section. Get medical||
1360|032|W|help right away if any of these very serious side effects occur:||
1360|033|W|slow/shallow breathing, unusual lightheadedness, severe||
1360|034|W|drowsiness/dizziness, difficulty waking up.||
1360|035|W|   The higher strength of this medication (40 milligrams||
1360|036|W|oxycodone/20 milligrams naloxone per tablet) should be used only||
1360|037|W|if you have been regularly taking moderate to large amounts of an||
1360|038|W|opioid pain medication. This strength may cause overdose (even||
1360|039|W|death) if taken by a person who has not been regularly taking||
1360|040|W|opioids. This medication should be used only for ongoing pain||
1360|041|W|that requires strong opioid pain medication at all times for an||
1360|042|W|extended period. It should not be used for quick relief (for use||
1360|043|W|as needed) of sudden, short-term or "breakthrough" pain.||
1360|044|W|   Do not break, crush, chew, or dissolve this medication. Taking||
1360|045|W|broken, crushed, chewed, or dissolved sustained-action oxycodone||
1360|046|W|could cause a fatal overdose.||
1360|047|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1360|048|W|or abuse. If someone accidentally swallows this drug, get medical||
1360|049|W|help right away.||
1360|050|W|   Before using this medication, women of childbearing age should||
1360|051|W|talk with their doctor(s) about the risks and benefits. Tell your||
1360|052|W|doctor if you are pregnant or if you plan to become pregnant.||
1360|053|W|During pregnancy, this medication should be used only when||
1360|054|W|clearly needed. It may slightly increase the risk of birth||
1360|055|W|defects if used during the first two months of pregnancy. Also,||
1360|056|W|using it for a long time or in high doses near the expected||
1360|057|W|delivery date may harm the unborn baby. To lessen the risk, take||
1360|058|W|the smallest effective dose for the shortest possible time.||
1360|059|W|Babies born to mothers who use this drug for a long time may||
1360|060|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1360|061|W|doctor right away if you notice any symptoms in your newborn baby||
1360|062|W|such as crying that doesn't stop, slow/shallow breathing,||
1360|063|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1360|064|W|difficulty gaining weight.||
1360|065|B|||
1360|066|U|USES:  This medication contains oxycodone and naloxone in a||
1360|067|U|tablet designed to release them slowly. Oxycodone is used to help||
1360|068|U|relieve severe ongoing pain (such as due to cancer). Oxycodone||
1360|069|U|belongs to a class of drugs known as opioid analgesics. It works||
1360|070|U|in the brain to change how your body feels and responds to pain.||
1360|071|U|   Do not use this medication to relieve pain that is mild, due||
1360|072|U|to surgery, or that will go away in a few days. This medication||
1360|073|U|is not for occasional ("as needed") use.||
1360|074|U|   Naloxone is a opioid antagonist that blocks the effect of||
1360|075|U|oxycodone in the gut. This helps prevent constipation that||
1360|076|U|commonly occurs with strong opioids.||
1360|077|B|||
1360|078|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1360|079|H|from your pharmacist before you start taking this medication and||
1360|080|H|each time you get a refill. If you have any questions, ask your||
1360|081|H|doctor or pharmacist.||
1360|082|H|   Take this medication on a regular schedule as directed by your||
1360|083|H|doctor, not as needed for sudden (breakthrough) pain. It is||
1360|084|H|usually taken every 12 hours at the same times each day. If you||
1360|085|H|miss several doses in a row, call your doctor before restarting||
1360|086|H|the medication. Take this drug with a glass of water (4-6||
1360|087|H|ounces/120-180 milliliters), with or without food. If you have||
1360|088|H|nausea, it may help to take this drug with food. Ask your doctor||
1360|089|H|or pharmacist about other ways to decrease nausea (such as lying||
1360|090|H|down for 1 to 2 hours with as little head movement as possible).||
1360|091|H|   Swallow the tablets whole. Do not break, crush, chew, or||
1360|092|H|dissolve the tablets. Doing so can release all of the drug at||
1360|093|H|once, increasing the risk of oxycodone overdose.||
1360|094|H|   Do not inject ("shoot up"), inhale through the nose ("snort"),||
1360|095|H|or use oxycodone/naloxone rectally. Doing so is dangerous, may||
1360|096|H|cause an overdose, and will likely cause severe withdrawal||
1360|097|H|symptoms due to the naloxone in this medication.||
1360|098|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1360|099|H|using this medication unless your doctor or pharmacist says you||
1360|100|H|may do so safely. Grapefruit can increase the chance of side||
1360|101|H|effects with this medicine. Ask your doctor or pharmacist for||
1360|102|H|more details.||
1360|103|H|   The dosage is based on your medical condition and response to||
1360|104|H|treatment. Your doctor will adjust the dose slowly to find the||
1360|105|H|best dose to control your pain with the least side effects. Do||
1360|106|H|not increase your dose, take the medication more often, or take||
1360|107|H|it for a longer time than prescribed. Properly stop the||
1360|108|H|medication when so directed.||
1360|109|H|   Before you start taking this medication, ask your doctor or||
1360|110|H|pharmacist if you should stop or change how you use your other||
1360|111|H|opioid medication(s). Other pain relievers (such as||
1360|112|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1360|113|H|or pharmacist about using oxycodone safely with other drugs.||
1360|114|H|   Suddenly stopping this medication may cause withdrawal,||
1360|115|H|especially if you have used it for a long time or in high doses.||
1360|116|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1360|117|H|Tell your doctor or pharmacist right away if you have any||
1360|118|H|withdrawal symptoms such as restlessness, mental/mood changes||
1360|119|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1360|120|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1360|121|H|aches, or sudden changes in behavior.||
1360|122|H|   When this medication is used for a long time, it may not work||
1360|123|H|as well. Talk with your doctor if this medication stops working||
1360|124|H|well.||
1360|125|H|   Though it helps many people, this medication may sometimes||
1360|126|H|cause addiction. This risk may be higher if you have a||
1360|127|H|mental/mood disorder or a substance use disorder (such as overuse||
1360|128|H|of or addiction to drugs/alcohol). Take this medication exactly||
1360|129|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1360|130|H|pharmacist for more details.||
1360|131|H|   Tell your doctor if your pain does not get better or if it||
1360|132|H|gets worse, or if you have any new pain.||
1360|133|B|||
1360|134|S|SIDE EFFECTS:  See also Warning section.||
1360|135|S|   Nausea, vomiting, diarrhea, lightheadedness, dizziness, or||
1360|136|S|drowsiness may occur. Some of these side effects may decrease||
1360|137|S|after you have been using this medication for a while. Tell your||
1360|138|S|doctor if you continue to have diarrhea after 3 days. If any of||
1360|139|S|these effects last or get worse, tell your doctor or pharmacist||
1360|140|S|promptly.||
1360|141|S|   To reduce the risk of dizziness and lightheadedness, get up||
1360|142|S|slowly when rising from a sitting or lying position.||
1360|143|S|   You may notice an empty tablet shell in your stool. This is||
1360|144|S|harmless because your body has already absorbed the medicine.||
1360|145|S|   Remember that this medication has been prescribed because your||
1360|146|S|doctor has judged that the benefit to you is greater than the||
1360|147|S|risk of side effects. Many people using this medication do not||
1360|148|S|have serious side effects.||
1360|149|S|   Tell your doctor right away if you have any serious side||
1360|150|S|effects, including: interrupted breathing during sleep (sleep||
1360|151|S|apnea), mental/mood changes (such as agitation, confusion,||
1360|152|S|hallucinations), difficulty walking/speaking, severe||
1360|153|S|stomach/abdominal pain, difficulty urinating, signs of your||
1360|154|S|adrenal glands not working well (such as loss of appetite,||
1360|155|S|unusual tiredness, weight loss), trouble swallowing.||
1360|156|S|   Get medical help right away if you have any very serious side||
1360|157|S|effects, including: fainting, fast/slow heartbeat, seizure,||
1360|158|S|slow/shallow breathing, severe drowsiness/difficulty waking up.||
1360|159|S|   A very serious allergic reaction to this drug is rare.||
1360|160|S|However, get medical help right away if you notice any symptoms||
1360|161|S|of a serious allergic reaction, including: rash, itching/swelling||
1360|162|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1360|163|S|breathing.||
1360|164|S|   This is not a complete list of possible side effects. If you||
1360|165|S|notice other effects not listed above, contact your doctor or||
1360|166|S|pharmacist.||
1360|167|S|   In the US -||
1360|168|S|   Call your doctor for medical advice about side effects. You||
1360|169|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1360|170|S|www.fda.gov/medwatch.||
1360|171|S|   In Canada - Call your doctor for medical advice about side||
1360|172|S|effects. You may report side effects to Health Canada at||
1360|173|S|1-866-234-2345.||
1360|174|B|||
1360|175|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1360|176|P|pharmacist if you are allergic to oxycodone or naloxone; or to||
1360|177|P|other opioid pain relievers (such as oxymorphone); or if you have||
1360|178|P|any other allergies. This product may contain inactive||
1360|179|P|ingredients, which can cause allergic reactions or other||
1360|180|P|problems. Talk to your pharmacist for more details.||
1360|181|P|   Before using this medication, tell your doctor or pharmacist||
1360|182|P|your medical history, especially of: brain disorders (such as||
1360|183|P|head injury, tumor, seizure), breathing problems (such as asthma,||
1360|184|P|sleep apnea, chronic obstructive pulmonary disease-COPD), heart||
1360|185|P|problems (such as chest pain, low blood pressure, heart failure),||
1360|186|P|kidney disease, liver disease, mental/mood disorders (such as||
1360|187|P|confusion, depression), personal or family history of a substance||
1360|188|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
1360|189|P|stomach/intestinal problems (such as blockage, constipation,||
1360|190|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
1360|191|P|(such as due to enlarged prostate), gallbladder disease, disease||
1360|192|P|of the pancreas (pancreatitis).||
1360|193|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1360|194|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1360|195|P|machinery, or do anything that needs alertness until you can do||
1360|196|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1360|197|P|are using marijuana (cannabis).||
1360|198|P|   Before having surgery, tell your doctor or dentist about all||
1360|199|P|the products you use (including prescription drugs,||
1360|200|P|nonprescription drugs, and herbal products).||
1360|201|P|   Older adults may be more sensitive to the side effects of this||
1360|202|P|drug, especially confusion, dizziness, drowsiness, and||
1360|203|P|slow/shallow breathing.||
1360|204|P|   During pregnancy, this medication should be used only when||
1360|205|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1360|206|P|benefits with your doctor. (See also Warning section.)||
1360|207|P|   This drug passes into breast milk and may have undesirable||
1360|208|P|effects on a nursing infant. Tell the doctor right away if your||
1360|209|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1360|210|P|breathing. Breastfeeding is not recommended while using this||
1360|211|P|drug. Consult your doctor before breastfeeding.||
1360|212|B|||
1360|213|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
1360|214|I|   Drug interactions may change how your medications work or||
1360|215|I|increase your risk for serious side effects. This document does||
1360|216|I|not contain all possible drug interactions. Keep a list of all||
1360|217|I|the products you use (including prescription/nonprescription||
1360|218|I|drugs and herbal products) and share it with your doctor and||
1360|219|I|pharmacist. Do not start, stop, or change the dosage of any||
1360|220|I|medicines without your doctor's approval.||
1360|221|I|   Some products that may interact with this drug include:||
1360|222|I|certain pain medications (mixed opioid agonist-antagonists such||
1360|223|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1360|224|I|samidorphan.||
1360|225|I|   The risk of serious side effects (such as slow/shallow||
1360|226|I|breathing, severe drowsiness/dizziness) may be increased if this||
1360|227|I|medication is taken with other products that may also cause||
1360|228|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1360|229|I|if you are taking other products such as other opioid pain or||
1360|230|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1360|231|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1360|232|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1360|233|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1360|234|I|cetirizine, diphenhydramine).||
1360|235|I|   Check the labels on all your medicines (such as allergy or||
1360|236|I|cough-and-cold products) because they may contain ingredients||
1360|237|I|that cause drowsiness. Ask your pharmacist about using those||
1360|238|I|products safely.||
1360|239|I|   Other medications can affect the removal of oxycodone from||
1360|240|I|your body, which may affect how oxycodone works. Examples include||
1360|241|I|azole antifungals (such as ketoconazole), macrolide antibiotics||
1360|242|I|(such as erythromycin), mifepristone, HIV medications (such as||
1360|243|I|tipranavir), rifamycins (such as rifabutin, rifampin), ritonavir,||
1360|244|I|certain drugs used to treat seizures (such as carbamazepine,||
1360|245|I|phenytoin), among others.||
1360|246|I|   This medication may interfere with certain lab tests (such as||
1360|247|I|amylase/lipase levels), possibly causing false test results. Make||
1360|248|I|sure lab personnel and all your doctors know you use this drug.||
1360|249|B|||
1360|250|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1360|251|O|as passing out or trouble breathing, give them naloxone by itself||
1360|252|O|or nalmefene if available, then call 911. If the person is awake||
1360|253|O|and has no symptoms, call a poison control center right away. US||
1360|254|O|residents can call 1-800-222-1222. Canada residents can call||
1360|255|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1360|256|O|breathing, slow heartbeat, coma.||
1360|257|B|||
1360|258|N|NOTES:  Do not share this medication with others. Sharing it is||
1360|259|N|against the law.||
1360|260|N|   This medication has been prescribed for your current condition||
1360|261|N|only. Do not use it later for another condition unless told to do||
1360|262|N|so by your doctor. A different medication may be necessary in||
1360|263|N|that case.||
1360|264|B|||
1360|265|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1360|266|D|If it is near the time of the next dose, skip the missed dose.||
1360|267|D|Use your next dose at the regular time. Do not double the dose to||
1360|268|D|catch up.||
1360|269|B|||
1360|270|R|STORAGE:  Store at room temperature away from light and moisture.||
1360|271|R|Do not store in the bathroom. Keep all medications away from||
1360|272|R|children and pets.||
1360|273|R|   Do not flush medications down the toilet or pour them into a||
1360|274|R|drain unless instructed to do so. Properly discard this product||
1360|275|R|when it is expired or no longer needed. Consult your pharmacist||
1360|276|R|or local waste disposal company.||
1360|277|B|||
1360|278|A|Information last revised August 2025.||
1360|279|A|Copyright(c) 2025 First Databank, Inc.||
1360|280|B|||
1361|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1361|002|Z|does NOT have all possible information about this product. This||
1361|003|Z|information does not assure that this product is safe, effective,||
1361|004|Z|or appropriate for you. This information is not individual||
1361|005|Z|medical advice and does not substitute for the advice of your||
1361|006|Z|health care professional. Always ask your health care||
1361|007|Z|professional for complete information about this product and your||
1361|008|Z|specific health needs.||
1361|009|B|||
1361|010|T|FERUMOXYTOL - INJECTION||
1361|011|F|(FER-ue-MOX-i-tol)||
1361|012|B|||
1361|013|C|COMMON BRAND NAME(S): Feraheme||
1361|014|B|||
1361|015|W|WARNING:  Rarely, some people using this medication have had a||
1361|016|W|serious allergic reaction, even if they did not have a reaction||
1361|017|W|in the past. You will need to stay in a clinic or hospital during||
1361|018|W|and for at least 30 minutes after your injection so your doctor||
1361|019|W|can monitor you closely and check your blood pressure and pulse.||
1361|020|W|Get medical help right away if you develop symptoms such as rash,||
1361|021|W|itching/swelling (especially of the face/tongue/throat), severe||
1361|022|W|dizziness, fainting, trouble breathing.||
1361|023|B|||
1361|024|U|USES:  This medication is used to treat "iron-poor" blood (iron||
1361|025|U|deficiency anemia). Ferumoxytol is a form of injectable iron that||
1361|026|U|is used if you cannot take iron by mouth because of side effects||
1361|027|U|or an unsuccessful response to treatment. It is also used by||
1361|028|U|people who have anemia due to long-term kidney disease.||
1361|029|U|   Iron is an important part of your red blood cells and is||
1361|030|U|needed to carry oxygen throughout the body. Many people with||
1361|031|U|kidney disease cannot get enough iron from food and require||
1361|032|U|injections. People with kidney disease may also need extra iron||
1361|033|U|because of blood loss during kidney dialysis treatment.||
1361|034|B|||
1361|035|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1361|036|H|from your pharmacist before you start using ferumoxytol and each||
1361|037|H|time you get a refill. If you have any questions, ask your doctor||
1361|038|H|or pharmacist.||
1361|039|H|   Ferumoxytol is given by a health care professional. It is||
1361|040|H|given by slow injection into a vein over at least 15 minutes,||
1361|041|H|usually in a clinic or hospital. Treatment involves receiving two||
1361|042|H|doses of ferumoxytol, given 3 to 8 days apart. It may be given||
1361|043|H|during dialysis.||
1361|044|H|   The dosage is based on your medical condition and response to||
1361|045|H|treatment. Your doctor will take blood tests to monitor your||
1361|046|H|response to treatment.||
1361|047|B|||
1361|048|S|SIDE EFFECTS:  See also Warning section.||
1361|049|S|   Dizziness or fainting (hypotension) may occur. Pain, swelling,||
1361|050|S|or redness at the injection site may also occur. If any of these||
1361|051|S|effects last or get worse, tell your doctor or pharmacist||
1361|052|S|promptly.||
1361|053|S|   To reduce the risk of dizziness or fainting, get up slowly||
1361|054|S|when rising from a sitting or lying position.||
1361|055|S|   Remember that this medication has been prescribed because your||
1361|056|S|doctor has judged that the benefit to you is greater than the||
1361|057|S|risk of side effects. Many people using this medication do not||
1361|058|S|have serious side effects.||
1361|059|S|   Tell your doctor right away if you have any serious side||
1361|060|S|effects, including: unusual bruising, darkening of skin (bronze||
1361|061|S|tone), swelling of hands/feet/lower legs, chest pain.||
1361|062|S|   This is not a complete list of possible side effects. If you||
1361|063|S|notice other effects not listed above, contact your doctor or||
1361|064|S|pharmacist.||
1361|065|S|   In the US -||
1361|066|S|   Call your doctor for medical advice about side effects. You||
1361|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1361|068|S|www.fda.gov/medwatch.||
1361|069|S|   In Canada - Call your doctor for medical advice about side||
1361|070|S|effects. You may report side effects to Health Canada at||
1361|071|S|1-866-234-2345.||
1361|072|B|||
1361|073|P|PRECAUTIONS:  Before using ferumoxytol, tell your doctor or||
1361|074|P|pharmacist if you are allergic to it; or if you have had a||
1361|075|P|reaction to other types of injectable iron; or if you have any||
1361|076|P|other allergies. This product may contain inactive ingredients,||
1361|077|P|which can cause allergic reactions or other problems. Talk to||
1361|078|P|your pharmacist for more details.||
1361|079|P|   Before using this medication, tell your doctor or pharmacist||
1361|080|P|your medical history.||
1361|081|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1361|082|P|can make you more dizzy. Do not drive, use machinery, or do||
1361|083|P|anything that needs alertness until you can do it safely. Limit||
1361|084|P|alcoholic beverages. Talk to your doctor if you are using||
1361|085|P|marijuana (cannabis).||
1361|086|P|   During use and for 3 months after your last injection, tell||
1361|087|P|X-ray staff that you use or used this medication. This medication||
1361|088|P|can interfere with the results of an MRI scan.||
1361|089|P|   Before having surgery, tell your doctor or dentist about all||
1361|090|P|the products you use (including prescription drugs,||
1361|091|P|nonprescription drugs, and herbal products).||
1361|092|P|   Older adults that have a serious allergic reaction or||
1361|093|P|dizziness while using this drug may have more severe symptoms.||
1361|094|P|   During pregnancy, this medication should be used only when||
1361|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1361|096|P|   It is unknown if this drug passes into breast milk. Consult||
1361|097|P|your doctor before breastfeeding.||
1361|098|B|||
1361|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1361|100|I|medications work or increase your risk for serious side effects.||
1361|101|I|This document does not contain all possible drug interactions.||
1361|102|I|Keep a list of all the products you use (including||
1361|103|I|prescription/nonprescription drugs and herbal products) and share||
1361|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1361|105|I|the dosage of any medicines without your doctor's approval.||
1361|106|I|   Some products that may interact with this drug include: other||
1361|107|I|iron products.||
1361|108|B|||
1361|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1361|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1361|111|O|poison control center right away. US residents can call||
1361|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1361|113|B|||
1361|114|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1361|115|N|iron level, blood pressure, pulse) should be done while you are||
1361|116|N|using this medication. Keep all medical and lab appointments.||
1361|117|N|   It is important to eat a well-balanced diet to get enough||
1361|118|N|iron, vitamins, and minerals. Good sources of iron include meats||
1361|119|N|(especially liver), eggs, raisins, figs, broccoli, brussels||
1361|120|N|sprouts, beans, lentils, and iron-fortified or enriched cereals.||
1361|121|N|Follow diet recommendations for your condition.||
1361|122|B|||
1361|123|D|MISSED DOSE:  It is important to get each dose of this medication||
1361|124|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1361|125|D|right away for a new dosing schedule.||
1361|126|B|||
1361|127|R|STORAGE:  Not applicable. This medication is given in a hospital||
1361|128|R|or clinic and will not be stored at home.||
1361|129|B|||
1361|130|A|Information last revised May 2024.||
1361|131|A|Copyright(c) 2025 First Databank, Inc.||
1361|132|B|||
1362|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1362|002|Z|does NOT have all possible information about this product. This||
1362|003|Z|information does not assure that this product is safe, effective,||
1362|004|Z|or appropriate for you. This information is not individual||
1362|005|Z|medical advice and does not substitute for the advice of your||
1362|006|Z|health care professional. Always ask your health care||
1362|007|Z|professional for complete information about this product and your||
1362|008|Z|specific health needs.||
1362|009|B|||
1362|010|T|FINGOLIMOD - ORAL||
1362|011|F|(fin-GOL-i-mod)||
1362|012|B|||
1362|013|C|COMMON BRAND NAME(S): Gilenya||
1362|014|B|||
1362|015|U|USES:  This medication is used to treat multiple sclerosis-MS. It||
1362|016|U|is not a cure for MS but it is thought to help by preventing||
1362|017|U|immune system cells (lymphocytes) from attacking the nerves in||
1362|018|U|your brain and spinal cord. It helps decrease the number of||
1362|019|U|episodes of worsening and may prevent or delay disability.||
1362|020|B|||
1362|021|H|HOW TO USE:  Read the Medication Guide provided by your||
1362|022|H|pharmacist before you start taking fingolimod and each time you||
1362|023|H|get a refill. If you have any questions, ask your doctor or||
1362|024|H|pharmacist.||
1362|025|H|   Take this medication by mouth with or without food as directed||
1362|026|H|by your doctor, usually once a day. The dosage is based on your||
1362|027|H|age and weight.||
1362|028|H|   Do not stop taking this medication without consulting your||
1362|029|H|doctor. Your condition may become worse when this drug is||
1362|030|H|stopped. Tell your doctor right away if your MS symptoms are much||
1362|031|H|worse after stopping fingolimod.||
1362|032|H|   Do not increase your dose or use this drug more often or for||
1362|033|H|longer than prescribed. Your condition will not improve any||
1362|034|H|faster, and your risk of side effects will increase.||
1362|035|H|   Take this medication regularly to get the most benefit from||
1362|036|H|it. To help you remember, take it at the same time each day.||
1362|037|H|   Tell your doctor if your condition gets worse.||
1362|038|B|||
1362|039|S|SIDE EFFECTS:  Cough, headache, back pain, or diarrhea may occur.||
1362|040|S|If any of these effects last or get worse, tell your doctor or||
1362|041|S|pharmacist promptly.||
1362|042|S|   Slow heartbeat may also occur, especially when you first start||
1362|043|S|this medication. You will be monitored for at least 6 hours after||
1362|044|S|the first dose to make sure your heartbeat does not go too slow.||
1362|045|S|You may also need to be monitored if you restart this medication||
1362|046|S|or after a dosage increase (in children). Ask your doctor for||
1362|047|S|more details.||
1362|048|S|   Remember that this medication has been prescribed because your||
1362|049|S|doctor has judged that the benefit to you is greater than the||
1362|050|S|risk of side effects. Many people using this medication do not||
1362|051|S|have serious side effects.||
1362|052|S|   This medication may raise your blood pressure. Check your||
1362|053|S|blood pressure regularly and tell your doctor if the results are||
1362|054|S|high.||
1362|055|S|   Tell your doctor right away if you have any serious side||
1362|056|S|effects, including: signs of liver disease (such as||
1362|057|S|nausea/vomiting that doesn't stop, loss of appetite,||
1362|058|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1362|059|S|shortness of breath, unusual tiredness.||
1362|060|S|   Fingolimod may increase the risk of skin cancer and lymphoma.||
1362|061|S|Tell your doctor right away if you notice any new or changing||
1362|062|S|skin growths/moles, or swollen lymph nodes.||
1362|063|S|   This medication can weaken your immune system/increase the||
1362|064|S|risk of infection while you are taking it and for 2 months after||
1362|065|S|your last dose. You may be more likely to get a serious (possibly||
1362|066|S|fatal) infection (such as bronchitis, pneumonia, herpes). Tell||
1362|067|S|your doctor right away if you develop any signs of infection||
1362|068|S|(such as sore throat that doesn't go away, fever, chills, cough,||
1362|069|S|sores, or blisters). Do not start fingolimod if you already have||
1362|070|S|an infection.||
1362|071|S|   This medication may increase your risk of getting a rare but||
1362|072|S|very serious (possibly fatal) brain infection (progressive||
1362|073|S|multifocal leukoencephalopathy-PML). Symptoms of PML can seem||
1362|074|S|like a worsening MS attack. Get medical help right away if you||
1362|075|S|have any of these side effects: clumsiness, loss of||
1362|076|S|coordination/balance, weakness, sudden change in your thinking||
1362|077|S|(such as confusion, difficulty concentrating, memory loss),||
1362|078|S|difficulty talking/walking, seizure.||
1362|079|S|   Get medical help right away if you have any very serious side||
1362|080|S|effects, including: very slow heartbeat, fast/irregular||
1362|081|S|heartbeat, severe dizziness, fainting, chest pain, eye||
1362|082|S|pain/sensitivity to light, vision changes (such as blurred||
1362|083|S|vision, blind spot/shadows in the center of your vision, color||
1362|084|S|changes), sudden/severe headache.||
1362|085|S|   A very serious allergic reaction to this drug is rare.||
1362|086|S|However, get medical help right away if you notice any symptoms||
1362|087|S|of a serious allergic reaction, including: rash, itching/swelling||
1362|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1362|089|S|breathing.||
1362|090|S|   This is not a complete list of possible side effects. If you||
1362|091|S|notice other effects not listed above, contact your doctor or||
1362|092|S|pharmacist.||
1362|093|S|   In the US -||
1362|094|S|   Call your doctor for medical advice about side effects. You||
1362|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1362|096|S|www.fda.gov/medwatch.||
1362|097|S|   In Canada - Call your doctor for medical advice about side||
1362|098|S|effects. You may report side effects to Health Canada at||
1362|099|S|1-866-234-2345.||
1362|100|B|||
1362|101|P|PRECAUTIONS:  Before taking fingolimod, tell your doctor or||
1362|102|P|pharmacist if you are allergic to it; or if you have any other||
1362|103|P|allergies. This product may contain inactive ingredients which||
1362|104|P|can cause allergic reactions or other problems. Talk to your||
1362|105|P|pharmacist for more details.||
1362|106|P|   Before using this medication, tell your doctor or pharmacist||
1362|107|P|your medical history, especially of: heart problems (such as||
1362|108|P|slow/irregular heartbeat, heart failure, previous heart attack,||
1362|109|P|chest pain, QT prolongation in the EKG), family history of||
1362|110|P|certain heart problems (QT prolongation in the EKG, sudden||
1362|111|P|cardiac death), low levels of magnesium/potassium in the blood,||
1362|112|P|stroke/mini-stroke, high blood pressure, breathing problems (such||
1362|113|P|as asthma, bronchitis, emphysema, sleep apnea),||
1362|114|P|current/recent/returning infection (including hepatitis and||
1362|115|P|tuberculosis), diabetes, fainting, certain eye problems (macular||
1362|116|P|edema, uveitis), liver disease.||
1362|117|P|   Fingolimod can make you more likely to get infections or may||
1362|118|P|make current infections worse. Stay away from anyone who has an||
1362|119|P|infection that may easily spread (such as chickenpox, COVID-19,||
1362|120|P|measles, flu). Talk to your doctor if you have been exposed to an||
1362|121|P|infection or for more details.||
1362|122|P|   Tell your doctor your vaccine history and ask if you need to||
1362|123|P|get any vaccines before starting treatment with this medication.||
1362|124|P|Tell your health care professional that you are using fingolimod||
1362|125|P|before having any immunizations/vaccinations. Avoid getting a||
1362|126|P|live vaccine for 2 months after the last dose of this medication.||
1362|127|P|Avoid contact with people who have recently received live||
1362|128|P|vaccines (such as flu vaccine inhaled through the nose).||
1362|129|P|   This medication may increase your risk of developing skin||
1362|130|P|cancer. Limit your time in the sun. Avoid tanning booths and||
1362|131|P|sunlamps. Use sunscreen and wear protective clothing when||
1362|132|P|outdoors. Your doctor may direct you to avoid phototherapy while||
1362|133|P|you use this product. Ask your doctor for details.||
1362|134|P|   Before having surgery, tell your doctor or dentist about all||
1362|135|P|the products you use (including prescription drugs,||
1362|136|P|nonprescription drugs, and herbal products).||
1362|137|P|   Tell your doctor if you are pregnant or plan to become||
1362|138|P|pregnant. You should not become pregnant while using fingolimod.||
1362|139|P|Fingolimod may harm an unborn baby. Your doctor should order a||
1362|140|P|pregnancy test before you start this medication. Ask about||
1362|141|P|reliable forms of birth control while using this medication and||
1362|142|P|for 2 months after the last dose. If you become pregnant, talk to||
1362|143|P|your doctor right away about the risks and benefits of this||
1362|144|P|medication.||
1362|145|P|   It is unknown if this drug passes into breast milk. Because of||
1362|146|P|the possible risk to the infant, breastfeeding is not recommended||
1362|147|P|while using this drug. Consult your doctor before breastfeeding.||
1362|148|B|||
1362|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1362|150|I|medications work or increase your risk for serious side effects.||
1362|151|I|This document does not contain all possible drug interactions.||
1362|152|I|Keep a list of all the products you use (including||
1362|153|I|prescription/nonprescription drugs and herbal products) and share||
1362|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
1362|155|I|the dosage of any medicines without your doctor's approval.||
1362|156|I|   Some of the products that may interact with this drug include:||
1362|157|I|drugs that slow down your heartbeat (including digoxin,||
1362|158|I|beta-blockers such as atenolol/metoprolol, calcium channel||
1362|159|I|blockers such as diltiazem/verapamil), certain drugs for||
1362|160|I|irregular heartbeat (including amiodarone, disopyramide,||
1362|161|I|dofetilide, dronedarone, ibutilide, procainamide, quinidine,||
1362|162|I|sotalol), other drugs that weaken the immune system/increase the||
1362|163|I|risk of infection (such as natalizumab, rituximab).||
1362|164|B|||
1362|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1362|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1362|167|O|poison control center right away. US residents can call||
1362|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1362|169|B|||
1362|170|N|NOTES:  Do not share this medication with others.||
1362|171|N|   Lab and/or medical tests (such as complete blood count, blood||
1362|172|N|pressure, pulse, EKG, MRI, eye/skin exams, liver/lung function,||
1362|173|N|Pap smear) should be done before you start taking this medication||
1362|174|N|and while you are taking it. Keep all medical and lab||
1362|175|N|appointments. Consult your doctor for more details.||
1362|176|B|||
1362|177|D|MISSED DOSE:  It is very important to follow your treatment||
1362|178|D|regimen exactly. Ask your doctor ahead of time what you should do||
1362|179|D|if you miss a dose of fingolimod. Do not double the dose to catch||
1362|180|D|up.||
1362|181|B|||
1362|182|R|STORAGE:  Store at room temperature away from light and moisture.||
1362|183|R|Do not store in the bathroom. Keep all medications away from||
1362|184|R|children and pets.||
1362|185|R|   Do not flush medications down the toilet or pour them into a||
1362|186|R|drain unless instructed to do so. Properly discard this product||
1362|187|R|when it is expired or no longer needed. Consult your pharmacist||
1362|188|R|or local waste disposal company.||
1362|189|B|||
1362|190|A|Information last revised April 2025.||
1362|191|A|Copyright(c) 2025 First Databank, Inc.||
1362|192|B|||
1363|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1363|002|Z|does NOT have all possible information about this product. This||
1363|003|Z|information does not assure that this product is safe, effective,||
1363|004|Z|or appropriate for you. This information is not individual||
1363|005|Z|medical advice and does not substitute for the advice of your||
1363|006|Z|health care professional. Always ask your health care||
1363|007|Z|professional for complete information about this product and your||
1363|008|Z|specific health needs.||
1363|009|B|||
1363|010|T|DROSPIRENONE/ETHINYL ESTRADIOL/FOLATE SUPPLEMENT 24/4 - ORAL||
1363|011|F|(droe-SPYE-re-none/ETH-i-nil ES-tra-DYE-ol/FOE-late)||
1363|012|B|||
1363|013|C|COMMON BRAND NAME(S): Beyaz||
1363|014|B|||
1363|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
1363|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
1363|017|W|stroke, heart attack, blood clots, and high blood pressure from||
1363|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
1363|019|W|of these serious problems increases with age and with the number||
1363|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
1363|021|B|||
1363|022|U|USES:  This combination hormone medication is used to prevent||
1363|023|U|pregnancy. It contains 2 hormones: drospirenone (a progestin) and||
1363|024|U|ethinyl estradiol (an estrogen).||
1363|025|U|   This product also contains a folate supplement (such as||
1363|026|U|l-methylfolate, levomefolate). Folate is a B-vitamin that women||
1363|027|U|of childbearing age use to help prevent spinal cord birth defects||
1363|028|U|in an unborn baby. The folate supplement in this medication,||
1363|029|U|along with a diet rich in folate, lowers this risk if you become||
1363|030|U|pregnant while taking this drug or soon after you stop taking it.||
1363|031|U|   This medication also may be used to treat premenstrual||
1363|032|U|dysphoric disorder (PMDD) or moderate acne if you have chosen to||
1363|033|U|use birth control pills as your method of pregnancy prevention.||
1363|034|U|   Besides preventing pregnancy, birth control pills may make||
1363|035|U|your periods more regular, and may decrease blood loss, painful||
1363|036|U|periods, and the risk of ovarian cysts.||
1363|037|U|   This medication does not protect against sexually transmitted||
1363|038|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1363|039|U|an effective barrier method (latex or polyurethane condom/dental||
1363|040|U|dams) during sexual activity will help to decrease your risk of||
1363|041|U|infection.||
1363|042|B|||
1363|043|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1363|044|H|your pharmacist before you start taking this product and each||
1363|045|H|time you get a refill. The leaflet contains very important||
1363|046|H|information on when to take your pills and what to do if you miss||
1363|047|H|a dose. If you have any questions, ask your doctor or pharmacist.||
1363|048|H|   Take this medication by mouth with or without food as directed||
1363|049|H|by your doctor, usually once daily. Pick a time of day that is||
1363|050|H|easy for you to remember, and take your pill at the same time||
1363|051|H|each day.||
1363|052|H|   It is very important to keep taking this medication exactly as||
1363|053|H|prescribed by your doctor. Follow the package instructions to||
1363|054|H|find the first tablet, start with the first tablet in the pack,||
1363|055|H|and take them in the correct order. Do not skip any doses.||
1363|056|H|Pregnancy is more likely if you miss pills, start a new pack||
1363|057|H|late, or take your pill at a different time of the day than||
1363|058|H|usual.||
1363|059|H|   If you have vomiting or diarrhea within 4 hours after taking||
1363|060|H|your tablet, read the Patient Information Leaflet section titled||
1363|061|H|"What to Do if You Miss Tablets." Follow the instructions as if||
1363|062|H|you had missed your dose because vomiting/diarrhea can stop the||
1363|063|H|tablet from working.||
1363|064|H|   Taking this medication after your evening meal or at bedtime||
1363|065|H|may help if you have stomach upset or nausea with the medication.||
1363|066|H|You may choose to take this medication at another time of day||
1363|067|H|that is easier for you to remember. No matter what dosing||
1363|068|H|schedule you use, it is very important that you take this||
1363|069|H|medication at the same time each day, 24 hours apart.||
1363|070|H|   Your pill pack contains 24 pills with active medication||
1363|071|H|(hormones and folate). It also contains 4 reminder pills (without||
1363|072|H|hormones, but with folate) at the end of the pack. Take one||
1363|073|H|active pill (with hormones) once daily for 24 days in a row.||
1363|074|H|After you have taken the last active pill, take one reminder pill||
1363|075|H|(without hormones) once daily for 4 days in a row unless||
1363|076|H|otherwise directed by your doctor. You should have your period||
1363|077|H|usually within 3 days after you take the last active tablet in||
1363|078|H|the cycle. After you have taken the last reminder tablet in the||
1363|079|H|pack, start a new pack the next day even if your period is||
1363|080|H|continuing or if you do not have your period. If you do not get||
1363|081|H|your period, consult your doctor.||
1363|082|H|   If this is the first time you are using this medication and||
1363|083|H|you are not switching from another form of hormonal birth control||
1363|084|H|(such as patch, other birth control pills), take the first tablet||
1363|085|H|in the pack on the first Sunday following the beginning of your||
1363|086|H|menstrual period or on the first day of your period. If your||
1363|087|H|period begins on a Sunday, begin taking this medication on that||
1363|088|H|day. For the first cycle of use only, use a backup form of||
1363|089|H|non-hormonal birth control (such as condoms, spermicide) for the||
1363|090|H|first 7 days to prevent pregnancy until the medication has enough||
1363|091|H|time to work. If you start on the first day of your period, you||
1363|092|H|do not need to use backup birth control the first week.||
1363|093|H|   Ask your doctor or pharmacist for information about how to||
1363|094|H|switch from other forms of hormonal birth control (such as patch,||
1363|095|H|other birth control pills) to this product. If any information is||
1363|096|H|unclear, consult the Patient Information Leaflet or your doctor||
1363|097|H|or pharmacist.||
1363|098|B|||
1363|099|S|SIDE EFFECTS:  See also Precautions section.||
1363|100|S|   Nausea, vomiting, headache, abdominal cramps/bloating, breast||
1363|101|S|tenderness, swelling of the ankles/feet (retaining fluid), or||
1363|102|S|weight change may occur. Vaginal bleeding between periods||
1363|103|S|(spotting) or missed/irregular periods may occur, especially||
1363|104|S|during the first few months of use. If any of these effects last||
1363|105|S|or get worse, tell your doctor or pharmacist promptly. If you||
1363|106|S|miss 2 periods in a row (or 1 period if the pill has not been||
1363|107|S|used properly), contact your doctor for a pregnancy test.||
1363|108|S|   Remember that this medication has been prescribed because your||
1363|109|S|doctor has judged that the benefit to you is greater than the||
1363|110|S|risk of side effects. Many people using this medication do not||
1363|111|S|have serious side effects.||
1363|112|S|   This medication may raise your blood pressure. Check your||
1363|113|S|blood pressure regularly and tell your doctor if the results are||
1363|114|S|high.||
1363|115|S|   Tell your doctor right away if you have any serious side||
1363|116|S|effects, including: a lump in your breast, mental/mood changes||
1363|117|S|(such as new/worsening depression), unusual changes in vaginal||
1363|118|S|bleeding (such as continuous spotting, sudden heavy bleeding),||
1363|119|S|symptoms of a high level of potassium in the blood (such as||
1363|120|S|muscle weakness, slow/irregular heartbeat), severe||
1363|121|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
1363|122|S|   This medication may rarely cause serious (sometimes fatal)||
1363|123|S|problems from blood clots (such as heart attack, stroke, blood||
1363|124|S|clots in the lungs or legs). Get medical help right away if you||
1363|125|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1363|126|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
1363|127|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1363|128|S|trouble speaking, weakness on one side of the body, sudden vision||
1363|129|S|changes.||
1363|130|S|   A very serious allergic reaction to this drug is rare.||
1363|131|S|However, get medical help right away if you notice any symptoms||
1363|132|S|of a serious allergic reaction, including: rash, itching/swelling||
1363|133|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1363|134|S|breathing.||
1363|135|S|   This is not a complete list of possible side effects. If you||
1363|136|S|notice other effects not listed above, contact your doctor or||
1363|137|S|pharmacist.||
1363|138|S|   In the US -||
1363|139|S|   Call your doctor for medical advice about side effects. You||
1363|140|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1363|141|S|www.fda.gov/medwatch.||
1363|142|S|   In Canada - Call your doctor for medical advice about side||
1363|143|S|effects. You may report side effects to Health Canada at||
1363|144|S|1-866-234-2345.||
1363|145|B|||
1363|146|P|PRECAUTIONS:  See also Warning section.||
1363|147|P|   Before taking this medication, tell your doctor or pharmacist||
1363|148|P|if you are allergic to drospirenone, ethinyl estradiol, or folate||
1363|149|P|supplements; or to any estrogens (such as mestranol) or any||
1363|150|P|progestins (such as norethindrone, desogestrel); or if you have||
1363|151|P|any other allergies. This product may contain inactive||
1363|152|P|ingredients, which can cause allergic reactions or other||
1363|153|P|problems. Talk to your pharmacist for more details.||
1363|154|P|   Before using this product, tell your doctor or pharmacist your||
1363|155|P|medical history, especially of: adrenal gland problems, blood||
1363|156|P|clots (for example, in the legs, eyes, lungs), blood clotting||
1363|157|P|disorders (such as protein C or protein S deficiency), high blood||
1363|158|P|pressure, abnormal breast exam, cancer (especially endometrial or||
1363|159|P|breast cancer), high cholesterol or triglyceride (blood fat)||
1363|160|P|levels, depression, diabetes, family or personal history of a||
1363|161|P|certain swelling disorder (angioedema), gallbladder problems,||
1363|162|P|severe headaches/migraines, heart problems (such as heart valve||
1363|163|P|disease, irregular heartbeat, previous heart attack), history of||
1363|164|P|yellowing eyes/skin (jaundice) during pregnancy or while using||
1363|165|P|hormonal birth control (such as pills, patch), kidney disease,||
1363|166|P|liver disease, stroke, swelling (edema), thyroid problems,||
1363|167|P|unexplained vaginal bleeding, obesity.||
1363|168|P|   If you have diabetes, this medication may make it harder to||
1363|169|P|control your blood sugar levels. Check your blood sugar levels||
1363|170|P|regularly as directed and share the results with your doctor.||
1363|171|P|Tell your doctor right away if you have symptoms of high blood||
1363|172|P|sugar such as increased thirst/urination. Your doctor may need to||
1363|173|P|adjust your diabetes medication, exercise program, or diet.||
1363|174|P|   Tell your doctor if you just had or will be having surgery or||
1363|175|P|if you will be confined to a bed or chair for a long time (such||
1363|176|P|as on a long plane flight). These conditions increase your risk||
1363|177|P|of getting blood clots, especially if you are using hormonal||
1363|178|P|birth control. You may need to stop this medication for a time or||
1363|179|P|take special precautions.||
1363|180|P|   Before having surgery, tell your doctor or dentist about all||
1363|181|P|the products you use (including prescription drugs,||
1363|182|P|nonprescription drugs, and herbal products).||
1363|183|P|   This product may increase your potassium levels. Before using||
1363|184|P|potassium supplements or salt substitutes that contain potassium,||
1363|185|P|consult your doctor or pharmacist.||
1363|186|P|   This medication may cause blotchy, dark areas on your face and||
1363|187|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
1363|188|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
1363|189|P|wear protective clothing when outdoors.||
1363|190|P|   If you are nearsighted or wear contact lenses, you may develop||
1363|191|P|vision problems or trouble wearing your contact lenses. Contact||
1363|192|P|your eye doctor if these problems occur.||
1363|193|P|   It may take longer for you to become pregnant after you stop||
1363|194|P|taking birth control pills. Consult your doctor.||
1363|195|P|   This medication should not be used during pregnancy. If you||
1363|196|P|become pregnant or think you may be pregnant, tell your doctor||
1363|197|P|right away. If you have just given birth or had a pregnancy||
1363|198|P|loss/abortion after the first 3 months, talk with your doctor||
1363|199|P|about reliable forms of birth control, and find out when it is||
1363|200|P|safe to start using birth control that contains a form of||
1363|201|P|estrogen, such as this medication.||
1363|202|P|   A small amount of this medication passes into breast milk and||
1363|203|P|may have undesirable effects on a nursing infant. Consult your||
1363|204|P|doctor before breastfeeding.||
1363|205|B|||
1363|206|I|DRUG INTERACTIONS:  See also Precautions section.||
1363|207|I|   Drug interactions may change how your medications work or||
1363|208|I|increase your risk for serious side effects. This document does||
1363|209|I|not contain all possible drug interactions. Keep a list of all||
1363|210|I|the products you use (including prescription/nonprescription||
1363|211|I|drugs and herbal products) and share it with your doctor and||
1363|212|I|pharmacist. Do not start, stop, or change the dosage of any||
1363|213|I|medicines without your doctor's approval.||
1363|214|I|   Some products that may interact with this drug include:||
1363|215|I|aromatase inhibitors (such as anastrozole, exemestane,||
1363|216|I|letrozole), atazanavir/cobicistat, fezolinetant, ospemifene,||
1363|217|I|tamoxifen, tranexamic acid.||
1363|218|I|   Drospirenone may raise your potassium blood level. Tell your||
1363|219|I|doctor if you are regularly taking other drugs/products that can||
1363|220|I|also raise your potassium level (including aliskiren, ACE||
1363|221|I|inhibitors such as enalapril/lisinopril, angiotensin receptor||
1363|222|I|blockers such as losartan/valsartan, heparin, NSAIDs such as||
1363|223|I|ibuprofen/naproxen, potassium-sparing "water pills"/diuretics||
1363|224|I|such as eplerenone/spironolactone/triamterene).||
1363|225|I|   Some drugs may cause hormonal birth control to work less well||
1363|226|I|by decreasing the amount of birth control hormones in your body.||
1363|227|I|This effect can result in pregnancy. Examples include||
1363|228|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
1363|229|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
1363|230|I|seizures (such as barbiturates, carbamazepine, felbamate,||
1363|231|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
1363|232|I|nevirapine), among others.||
1363|233|I|   Tell your doctor when you start any new drug, and discuss if||
1363|234|I|you should use reliable backup birth control. Also tell your||
1363|235|I|doctor if you have any new spotting or breakthrough bleeding,||
1363|236|I|because these may be signs that your birth control is not working||
1363|237|I|well.||
1363|238|I|   This medication may interfere with certain lab tests (such as||
1363|239|I|blood tests for clotting factors, thyroid), possibly causing||
1363|240|I|false test results. Make sure lab personnel and all your doctors||
1363|241|I|know you use this drug.||
1363|242|B|||
1363|243|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1363|244|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1363|245|O|poison control center right away. US residents can call||
1363|246|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1363|247|O|Symptoms of overdose may include: severe nausea and vomiting,||
1363|248|O|sudden/unusual vaginal bleeding.||
1363|249|B|||
1363|250|N|NOTES:  Do not share this medication with others.||
1363|251|N|   Regular complete physical exams which include lab and/or||
1363|252|N|medical tests (such as potassium blood level, blood pressure,||
1363|253|N|breast exam, pelvic exam, Pap smear) should be done while you are||
1363|254|N|taking this medication. Follow your doctor's instructions for||
1363|255|N|examining your breasts, and report any lumps right away. Keep all||
1363|256|N|medical and lab appointments. Consult your doctor for more||
1363|257|N|details.||
1363|258|B|||
1363|259|D|MISSED DOSE:  Missed dose advice is different depending on the||
1363|260|D|brand used and the number of doses missed. Refer to the product||
1363|261|D|package information for advice on missed doses. You may need to||
1363|262|D|use backup birth control (such as condoms, spermicide) to prevent||
1363|263|D|pregnancy. Ask your doctor or pharmacist if you have any||
1363|264|D|questions.||
1363|265|D|   If you often forget to take your pills as directed, contact||
1363|266|D|your doctor to discuss switching to another form of birth||
1363|267|D|control.||
1363|268|B|||
1363|269|R|STORAGE:  Store at room temperature away from light and moisture.||
1363|270|R|Do not store in the bathroom. Keep all medications away from||
1363|271|R|children and pets.||
1363|272|R|   Do not flush medications down the toilet or pour them into a||
1363|273|R|drain unless instructed to do so. Properly discard this product||
1363|274|R|when it is expired or no longer needed. Consult your pharmacist||
1363|275|R|or local waste disposal company.||
1363|276|B|||
1363|277|A|Information last revised October 2025.||
1363|278|A|Copyright(c) 2025 First Databank, Inc.||
1363|279|B|||
1364|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1364|002|Z|does NOT have all possible information about this product. This||
1364|003|Z|information does not assure that this product is safe, effective,||
1364|004|Z|or appropriate for you. This information is not individual||
1364|005|Z|medical advice and does not substitute for the advice of your||
1364|006|Z|health care professional. Always ask your health care||
1364|007|Z|professional for complete information about this product and your||
1364|008|Z|specific health needs.||
1364|009|B|||
1364|010|T|ERWINIA ASPARAGINASE - INJECTION||
1364|011|F|(er-WIN-ee-a as-PAR-a-jin-ase)||
1364|012|B|||
1364|013|C|COMMON BRAND NAME(S): Erwinaze||
1364|014|B|||
1364|015|U|USES:  Erwinia asparaginase is used to treat acute lymphoblastic||
1364|016|U|leukemia (ALL). It works by starving tumor cells of needed||
1364|017|U|nutrients and slowing tumor cell growth.||
1364|018|B|||
1364|019|H|HOW TO USE:  This medication may be given by injection into a||
1364|020|H|muscle as directed by your doctor. The injection is given by a||
1364|021|H|health care professional. Some brands may also be given by||
1364|022|H|injection under the skin or into a vein by a health care||
1364|023|H|professional, usually in a hospital setting. The dosage and||
1364|024|H|treatment schedule are based on your medical condition and||
1364|025|H|response to treatment.||
1364|026|H|   Your doctor may give you other medication(s) to help prevent||
1364|027|H|allergic reactions.||
1364|028|B|||
1364|029|S|SIDE EFFECTS:  Pain or swelling at the injection site, nausea,||
1364|030|S|vomiting, loss of appetite, headache, or tiredness may occur.||
1364|031|S|Nausea and vomiting can be severe. In some cases, your doctor may||
1364|032|S|prescribe medication to prevent or relieve nausea and vomiting.||
1364|033|S|Eating several small meals, not eating before treatment, or||
1364|034|S|limiting activity may help lessen some of these effects. If any||
1364|035|S|of these effects last or get worse, tell your doctor or||
1364|036|S|pharmacist promptly.||
1364|037|S|   Remember that this medication has been prescribed because your||
1364|038|S|doctor has judged that the benefit to you is greater than the||
1364|039|S|risk of side effects. Many people using this medication do not||
1364|040|S|have serious side effects.||
1364|041|S|   Tell your doctor right away if you have any serious side||
1364|042|S|effects, including: signs of liver disease (such as||
1364|043|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1364|044|S|swelling of the stomach/abdomen, pain/redness/swelling of arms or||
1364|045|S|legs, muscle/joint pain, unusual bleeding/bruising (such as nose||
1364|046|S|bleeds, black or bloody stools), signs of high blood sugar (such||
1364|047|S|as increased thirst, frequent urination).||
1364|048|S|   Get medical help right away if you have any very serious side||
1364|049|S|effects, including: vision changes, severe headache, severe||
1364|050|S|dizziness, seizures, chest pain.||
1364|051|S|   This medication may lower your ability to fight infections.||
1364|052|S|This may make you more likely to get a serious (rarely fatal)||
1364|053|S|infection or make any infection you have worse. Tell your doctor||
1364|054|S|right away if you have any signs of infection (such as sore||
1364|055|S|throat that doesn't go away, fever, chills).||
1364|056|S|   A very serious allergic reaction to this drug is rare.||
1364|057|S|However, get medical help right away if you notice any symptoms||
1364|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1364|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1364|060|S|breathing.||
1364|061|S|   This is not a complete list of possible side effects. If you||
1364|062|S|notice other effects not listed above, contact your doctor or||
1364|063|S|pharmacist.||
1364|064|S|   In the US -||
1364|065|S|   Call your doctor for medical advice about side effects. You||
1364|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1364|067|S|www.fda.gov/medwatch.||
1364|068|S|   In Canada - Call your doctor for medical advice about side||
1364|069|S|effects. You may report side effects to Health Canada at||
1364|070|S|1-866-234-2345.||
1364|071|B|||
1364|072|P|PRECAUTIONS:  Before receiving this product, tell your doctor or||
1364|073|P|pharmacist if you are allergic to it; or to any erwinia||
1364|074|P|asparaginase products; or if you have any other allergies. This||
1364|075|P|product may contain inactive ingredients, which can cause||
1364|076|P|allergic reactions or other problems. Talk to your pharmacist for||
1364|077|P|more details.||
1364|078|P|   Before using this medication, tell your doctor or pharmacist||
1364|079|P|your medical history, especially of: pancreatitis, liver disease.||
1364|080|P|   Tell your health care professional that you are using erwinia||
1364|081|P|asparaginase before having any immunizations/vaccinations. Avoid||
1364|082|P|contact with people who have recently received live vaccines||
1364|083|P|(such as flu vaccine inhaled through the nose).||
1364|084|P|   To lower the chance of getting cut, bruised, or injured, use||
1364|085|P|caution with sharp objects like razors and nail cutters, and||
1364|086|P|avoid activities such as contact sports.||
1364|087|P|   Before having surgery, tell your doctor or dentist about all||
1364|088|P|the products you use (including prescription drugs,||
1364|089|P|nonprescription drugs, and herbal products).||
1364|090|P|   Tell your doctor if you are pregnant or plan to become||
1364|091|P|pregnant. You should not become pregnant while using this||
1364|092|P|medication. Erwinia asparaginase may harm an unborn baby. Your||
1364|093|P|doctor should order a pregnancy test before you start this||
1364|094|P|medication. Men and women using this medication should ask about||
1364|095|P|reliable forms of birth control during treatment and for 3 months||
1364|096|P|after the last dose. If you or your partner becomes pregnant,||
1364|097|P|talk to your doctor right away about the risks and benefits of||
1364|098|P|this medication.||
1364|099|P|   It is unknown if this drug passes into breast milk. Because of||
1364|100|P|the possible risk to the infant, breastfeeding is not recommended||
1364|101|P|while using this drug and for at least 3 months after the last||
1364|102|P|dose. Consult your doctor before breastfeeding.||
1364|103|B|||
1364|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1364|105|I|medications work or increase your risk for serious side effects.||
1364|106|I|This document does not contain all possible drug interactions.||
1364|107|I|Keep a list of all the products you use (including||
1364|108|I|prescription/nonprescription drugs and herbal products) and share||
1364|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
1364|110|I|the dosage of any medicines without your doctor's approval.||
1364|111|I|   This product may interfere with certain lab tests, possibly||
1364|112|I|causing false test results. Make sure lab personnel and all your||
1364|113|I|doctors know you use this drug.||
1364|114|B|||
1364|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1364|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1364|117|O|poison control center right away. US residents can call||
1364|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1364|119|B|||
1364|120|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
1364|121|N|liver function, amylase levels, blood sugar) should be done while||
1364|122|N|you are using this medication. Keep all medical and lab||
1364|123|N|appointments.||
1364|124|B|||
1364|125|D|MISSED DOSE:  It is important to get each dose of erwinia||
1364|126|D|asparaginase as scheduled. If you miss a dose, ask your doctor or||
1364|127|D|pharmacist right away for a new dosing schedule.||
1364|128|B|||
1364|129|R|STORAGE:  Not applicable. This medication is given in a hospital||
1364|130|R|or clinic and will not be stored at home.||
1364|131|B|||
1364|132|M|MEDICAL ALERT:  Your condition can cause complications in a||
1364|133|M|medical emergency. For information about enrolling in MedicAlert,||
1364|134|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1364|135|B|||
1364|136|A|Information last revised April 2025.||
1364|137|A|Copyright(c) 2025 First Databank, Inc.||
1364|138|B|||
1365|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1365|002|Z|does NOT have all possible information about this product. This||
1365|003|Z|information does not assure that this product is safe, effective,||
1365|004|Z|or appropriate for you. This information is not individual||
1365|005|Z|medical advice and does not substitute for the advice of your||
1365|006|Z|health care professional. Always ask your health care||
1365|007|Z|professional for complete information about this product and your||
1365|008|Z|specific health needs.||
1365|009|B|||
1365|010|T|SAXAGLIPTIN/METFORMIN EXTENDED-RELEASE - ORAL||
1365|011|F|(SAX-a-GLIP-tin/met-FOR-min)||
1365|012|B|||
1365|013|C|COMMON BRAND NAME(S): Kombiglyze XR||
1365|014|B|||
1365|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1365|016|W|cause a serious (sometimes fatal) condition called lactic||
1365|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1365|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1365|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1365|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1365|021|W|you are using certain drugs. For some conditions, your doctor may||
1365|022|W|tell you to stop taking this medication for a short time. Ask||
1365|023|W|your doctor or pharmacist for more details.||
1365|024|W|   Stop taking this medication and get medical help right away if||
1365|025|W|you have any symptoms of lactic acidosis, such as unusual||
1365|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1365|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1365|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1365|029|B|||
1365|030|U|USES:  Saxagliptin/metformin is used with a proper diet and||
1365|031|U|exercise program to control high blood sugar in people with type||
1365|032|U|2 diabetes. Controlling high blood sugar helps prevent kidney||
1365|033|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1365|034|U|function problems. Proper control of diabetes may also lessen||
1365|035|U|your risk of a heart attack or stroke.||
1365|036|U|   This product contains 2 medications: saxagliptin and||
1365|037|U|metformin. Saxagliptin works by increasing levels of natural||
1365|038|U|substances called incretins. Incretins help to control blood||
1365|039|U|sugar by increasing insulin release, especially after a meal.||
1365|040|U|They also decrease the amount of sugar your liver makes.||
1365|041|U|Metformin lowers blood sugar by helping to restore your body's||
1365|042|U|proper response to the insulin. It also decreases the amount of||
1365|043|U|sugar that your liver makes and that your stomach/intestines||
1365|044|U|absorb.||
1365|045|B|||
1365|046|H|HOW TO USE:  Read the Medication Guide provided by your||
1365|047|H|pharmacist before you start using saxagliptin/metformin and each||
1365|048|H|time you get a refill. If you have any questions, ask your doctor||
1365|049|H|or pharmacist.||
1365|050|H|   Take this medication by mouth as directed by your doctor,||
1365|051|H|usually once a day with the evening meal.||
1365|052|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1365|053|H|Doing so can release all of the drug at once, increasing the risk||
1365|054|H|of side effects.||
1365|055|H|   Drink plenty of fluids while taking this medication unless||
1365|056|H|otherwise directed by your doctor.||
1365|057|H|   The dosage is based on your medical condition, response to||
1365|058|H|treatment, and other medications you may be taking. Be sure to||
1365|059|H|tell your doctor and pharmacist about all the products you use||
1365|060|H|(including prescription drugs, nonprescription drugs, and herbal||
1365|061|H|products). To reduce your risk of side effects (such as upset||
1365|062|H|stomach), your doctor may direct you to start this medication at||
1365|063|H|a low dose and gradually increase your dose. Follow your doctor's||
1365|064|H|instructions carefully.||
1365|065|H|   Take this medication regularly to get the most benefit from||
1365|066|H|it. To help you remember, take it at the same time each day.||
1365|067|H|Carefully follow the medication treatment plan, meal plan, and||
1365|068|H|exercise program your doctor has recommended.||
1365|069|B|||
1365|070|S|SIDE EFFECTS:  See also Warning section.||
1365|071|S|   Nausea, vomiting, stomach upset, diarrhea, headache, or a||
1365|072|S|metallic taste in the mouth may occur. If any of these effects||
1365|073|S|last or get worse, tell your doctor or pharmacist promptly. If||
1365|074|S|stomach symptoms return later (after taking the same dose for||
1365|075|S|several days or weeks), tell your doctor right away. Stomach||
1365|076|S|symptoms that occur after the first days of your treatment may be||
1365|077|S|signs of lactic acidosis.||
1365|078|S|   An empty tablet shell may appear in your stool. This effect is||
1365|079|S|harmless because your body has already absorbed the medication.||
1365|080|S|   Remember that this medication has been prescribed because your||
1365|081|S|doctor has judged that the benefit to you is greater than the||
1365|082|S|risk of side effects. Many people using this medication do not||
1365|083|S|have serious side effects.||
1365|084|S|   Tell your doctor right away if you have any serious side||
1365|085|S|effects, including: joint pain, unusual skin blisters, signs of||
1365|086|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1365|087|S|unusual tiredness, unusual/sudden weight gain).||
1365|088|S|   This medication does not usually cause low blood sugar||
1365|089|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1365|090|S|prescribed with other diabetes medications, or if you do not get||
1365|091|S|enough calories from food, or if you do unusually heavy exercise.||
1365|092|S|Talk with your doctor or pharmacist about whether the dose of||
1365|093|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1365|094|S|of low blood sugar include sudden sweating, shaking, fast||
1365|095|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1365|096|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1365|097|S|treat low blood sugar. If you don't have these reliable forms of||
1365|098|S|glucose, rapidly raise your blood sugar by eating a quick source||
1365|099|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1365|100|S|juice or non-diet soda. Tell your doctor right away about the||
1365|101|S|reaction and the use of this product. To help prevent low blood||
1365|102|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1365|103|S|Check with your doctor or pharmacist to find out what you should||
1365|104|S|do if you miss a meal.||
1365|105|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1365|106|S|thirst/urination. If these symptoms occur, tell your doctor right||
1365|107|S|away. Your doctor may need to adjust your diabetes medication,||
1365|108|S|exercise program, or diet.||
1365|109|S|   Get medical help right away if you have any very serious side||
1365|110|S|effects, including: signs of disease of the pancreas (such as||
1365|111|S|severe stomach/abdominal pain which may spread to the back,||
1365|112|S|nausea/vomiting that doesn't stop).||
1365|113|S|   A very serious allergic reaction to this drug is rare.||
1365|114|S|However, get medical help right away if you notice any symptoms||
1365|115|S|of a serious allergic reaction, including: rash, itching/swelling||
1365|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1365|117|S|breathing.||
1365|118|S|   This is not a complete list of possible side effects. If you||
1365|119|S|notice other effects not listed above, contact your doctor or||
1365|120|S|pharmacist.||
1365|121|S|   In the US -||
1365|122|S|   Call your doctor for medical advice about side effects. You||
1365|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1365|124|S|www.fda.gov/medwatch.||
1365|125|S|   In Canada - Call your doctor for medical advice about side||
1365|126|S|effects. You may report side effects to Health Canada at||
1365|127|S|1-866-234-2345.||
1365|128|B|||
1365|129|P|PRECAUTIONS:  See also Warning section.||
1365|130|P|   Before taking this medication, tell your doctor or pharmacist||
1365|131|P|if you are allergic to saxagliptin or metformin; or if you have||
1365|132|P|any other allergies. This product may contain inactive||
1365|133|P|ingredients, which can cause allergic reactions or other||
1365|134|P|problems. Talk to your pharmacist for more details.||
1365|135|P|   Before using this medication, tell your doctor or pharmacist||
1365|136|P|your medical history, especially of: kidney disease, severe||
1365|137|P|breathing problems (such as obstructive lung disease, severe||
1365|138|P|asthma), blood problems (such as anemia, vitamin B12 deficiency),||
1365|139|P|liver disease, disease of the pancreas (pancreatitis), risk||
1365|140|P|factors for pancreatitis (such as stones in your gallbladder,||
1365|141|P|regular use/abuse of alcohol, high levels of fats/triglycerides||
1365|142|P|in the blood).||
1365|143|P|   Before having surgery or any X-ray/scanning procedure using||
1365|144|P|iodinated contrast, tell your doctor or dentist about all the||
1365|145|P|products you use (including prescription drugs, nonprescription||
1365|146|P|drugs, and herbal products). You may need to stop this medication||
1365|147|P|for a short time for the surgery/procedure. Ask your doctor or||
1365|148|P|dentist for instructions before your surgery/procedure.||
1365|149|P|   You may experience blurred vision, dizziness, or drowsiness||
1365|150|P|due to extremely low or high blood sugar. Do not drive, use||
1365|151|P|machinery, or do anything that needs alertness or clear vision||
1365|152|P|until you can do it safely.||
1365|153|P|   Limit alcohol while taking this medication because it can||
1365|154|P|increase your risk of developing lactic acidosis, pancreatitis||
1365|155|P|and low blood sugar.||
1365|156|P|   High fever, "water pills" (diuretics such as||
1365|157|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1365|158|P|may cause dehydration and increase your risk of lactic acidosis.||
1365|159|P|Stop taking this medication and tell your doctor right away if||
1365|160|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1365|161|P|fluids to prevent dehydration unless your doctor directs you||
1365|162|P|otherwise.||
1365|163|P|   It may be harder to control your blood sugar when your body is||
1365|164|P|stressed (such as due to fever, infection, injury, or surgery).||
1365|165|P|Consult your doctor because this may require a change in your||
1365|166|P|treatment plan, medications, or blood sugar testing.||
1365|167|P|   Older adults may be more sensitive to the side effects of this||
1365|168|P|drug, especially low blood sugar or lactic acidosis.||
1365|169|P|   Metformin can cause changes in the menstrual cycle (promote||
1365|170|P|ovulation) and increase the chance of pregnancy. Consult your||
1365|171|P|doctor or pharmacist about using reliable birth control while||
1365|172|P|taking this medication.||
1365|173|P|   During pregnancy, this medication should be used only when||
1365|174|P|clearly needed. Discuss the risks and benefits with your doctor.||
1365|175|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1365|176|P|your doctor for managing your blood sugar while pregnant. Your||
1365|177|P|doctor may change your diabetes treatment during your pregnancy||
1365|178|P|(such as diet and medications including insulin).||
1365|179|P|   Metformin passes into breast milk in small amounts. It is||
1365|180|P|unknown if saxagliptin passes into breast milk. Consult your||
1365|181|P|doctor before breastfeeding.||
1365|182|B|||
1365|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1365|184|I|medications work or increase your risk for serious side effects.||
1365|185|I|This document does not contain all possible drug interactions.||
1365|186|I|Keep a list of all the products you use (including||
1365|187|I|prescription/nonprescription drugs and herbal products) and share||
1365|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
1365|189|I|the dosage of any medicines without your doctor's approval.||
1365|190|I|   Other medications can affect the removal of saxagliptin from||
1365|191|I|your body, which may affect how saxagliptin works. Examples||
1365|192|I|include azole antifungals (such as itraconazole, ketoconazole),||
1365|193|I|nefazodone, telithromycin, ritonavir, among others.||
1365|194|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1365|195|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1365|196|I|heartbeat you would usually feel when your blood sugar falls too||
1365|197|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1365|198|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1365|199|I|   Many drugs can affect your blood sugar, making it harder to||
1365|200|I|control. Before you start, stop, or change any medication, talk||
1365|201|I|with your doctor or pharmacist about how the medication may||
1365|202|I|affect your blood sugar. Check your blood sugar regularly as||
1365|203|I|directed and share the results with your doctor. Tell your doctor||
1365|204|I|right away if you have symptoms of high or low blood sugar. (See||
1365|205|I|also Side Effects section.) Your doctor may need to adjust your||
1365|206|I|diabetes medication, exercise program, or diet.||
1365|207|B|||
1365|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1365|209|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1365|210|O|poison control center right away. US residents can call||
1365|211|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1365|212|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
1365|213|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
1365|214|O|rapid breathing, slow/irregular heartbeat.||
1365|215|B|||
1365|216|N|NOTES:  Do not share this medication with others.||
1365|217|N|   Attend a diabetes education program to learn more about how to||
1365|218|N|manage your diabetes with medications, diet, exercise, and||
1365|219|N|regular medical exams.||
1365|220|N|   Learn the symptoms of high and low blood sugar and how to||
1365|221|N|treat low blood sugar. Check your blood sugar regularly as||
1365|222|N|directed.||
1365|223|N|   Lab and/or medical tests (such as kidney function, liver||
1365|224|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
1365|225|N|should be done before you start taking this medication and while||
1365|226|N|you are taking it. Keep all medical and lab appointments. Consult||
1365|227|N|your doctor for more details.||
1365|228|B|||
1365|229|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1365|230|D|remember. If it is near the time of the next dose, skip the||
1365|231|D|missed dose. Take your next dose at the regular time. Do not||
1365|232|D|double the dose to catch up.||
1365|233|B|||
1365|234|R|STORAGE:  Store at room temperature away from light and moisture.||
1365|235|R|Do not store in the bathroom. Keep all medications away from||
1365|236|R|children and pets.||
1365|237|R|   Do not flush medications down the toilet or pour them into a||
1365|238|R|drain unless instructed to do so. Properly discard this product||
1365|239|R|when it is expired or no longer needed. Consult your pharmacist||
1365|240|R|or local waste disposal company.||
1365|241|B|||
1365|242|M|MEDICAL ALERT:  Your condition can cause complications in a||
1365|243|M|medical emergency. For information about enrolling in MedicAlert,||
1365|244|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1365|245|B|||
1365|246|A|Information last revised May 2025.||
1365|247|A|Copyright(c) 2025 First Databank, Inc.||
1365|248|B|||
1366|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1366|002|Z|does NOT have all possible information about this product. This||
1366|003|Z|information does not assure that this product is safe, effective,||
1366|004|Z|or appropriate for you. This information is not individual||
1366|005|Z|medical advice and does not substitute for the advice of your||
1366|006|Z|health care professional. Always ask your health care||
1366|007|Z|professional for complete information about this product and your||
1366|008|Z|specific health needs.||
1366|009|B|||
1366|010|T|ERIBULIN - INJECTION||
1366|011|F|(ER-i-BUE-lin)||
1366|012|B|||
1366|013|C|COMMON BRAND NAME(S): Halaven||
1366|014|B|||
1366|015|U|USES:  Eribulin is used to treat certain types of cancer (breast,||
1366|016|U|liposarcoma). It works by slowing or stopping the growth of||
1366|017|U|cancer cells.||
1366|018|B|||
1366|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1366|020|H|from your pharmacist before you start using eribulin and each||
1366|021|H|time you get a refill. If you have any questions, ask your doctor||
1366|022|H|or pharmacist.||
1366|023|H|   This medication is given by injection into a vein by a health||
1366|024|H|care professional. It is given on a schedule as directed by your||
1366|025|H|doctor. The dosage is based on your medical condition, body size,||
1366|026|H|and response to treatment.||
1366|027|B|||
1366|028|S|SIDE EFFECTS:  Nausea, constipation, watering eyes, loss of||
1366|029|S|appetite, dry mouth, changes in taste, trouble sleeping,||
1366|030|S|muscle/joint pain, dizziness, tiredness, or weakness may occur.||
1366|031|S|If any of these effects last or get worse, tell your doctor||
1366|032|S|promptly.||
1366|033|S|   Temporary hair loss may occur. Normal hair growth should||
1366|034|S|return after treatment has ended.||
1366|035|S|   People using this medication may have serious side effects.||
1366|036|S|However, you have been prescribed this drug because your doctor||
1366|037|S|has judged that the benefit to you is greater than the risk of||
1366|038|S|side effects. Careful monitoring by your doctor may decrease your||
1366|039|S|risk.||
1366|040|S|   Tell your doctor right away if you have any serious side||
1366|041|S|effects, including: easy bruising/bleeding,||
1366|042|S|numbness/tingling/burning in the hands/feet, signs of anemia||
1366|043|S|(such as unusual tiredness, pale skin).||
1366|044|S|   This medication can lower the body's ability to fight an||
1366|045|S|infection. Tell your doctor right away if you develop any signs||
1366|046|S|of an infection (such as sore throat that doesn't go away, fever,||
1366|047|S|chills, burning/painful urination).||
1366|048|S|   Get medical help right away if you have any very serious side||
1366|049|S|effects, including: fainting, fast/irregular heartbeat, severe||
1366|050|S|dizziness.||
1366|051|S|   A very serious allergic reaction to this drug is rare.||
1366|052|S|However, get medical help right away if you notice any symptoms||
1366|053|S|of a serious allergic reaction, including: rash, itching/swelling||
1366|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1366|055|S|breathing.||
1366|056|S|   This is not a complete list of possible side effects. If you||
1366|057|S|notice other effects not listed above, contact your doctor or||
1366|058|S|pharmacist.||
1366|059|S|   In the US -||
1366|060|S|   Call your doctor for medical advice about side effects. You||
1366|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1366|062|S|www.fda.gov/medwatch.||
1366|063|S|   In Canada - Call your doctor for medical advice about side||
1366|064|S|effects. You may report side effects to Health Canada at||
1366|065|S|1-866-234-2345.||
1366|066|B|||
1366|067|P|PRECAUTIONS:  Before using eribulin, tell your doctor or||
1366|068|P|pharmacist if you are allergic to it; or if you have any other||
1366|069|P|allergies. This product may contain inactive ingredients, which||
1366|070|P|can cause allergic reactions or other problems. Talk to your||
1366|071|P|pharmacist for more details.||
1366|072|P|   Before using this medication, tell your doctor or pharmacist||
1366|073|P|your medical history, especially of: blood/bone marrow problems||
1366|074|P|(such as low red/white blood cells and platelets), kidney||
1366|075|P|problems, liver problems.||
1366|076|P|   Eribulin may cause a condition that affects the heart rhythm||
1366|077|P|(QT prolongation). QT prolongation can rarely cause serious||
1366|078|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1366|079|P|as severe dizziness, fainting) that need medical attention right||
1366|080|P|away.||
1366|081|P|   The risk of QT prolongation may be increased if you have||
1366|082|P|certain medical conditions or are taking other drugs that may||
1366|083|P|cause QT prolongation. Before using eribulin, tell your doctor or||
1366|084|P|pharmacist of all the drugs you take and if you have any of the||
1366|085|P|following conditions: certain heart problems (heart failure, slow||
1366|086|P|heartbeat, QT prolongation in the EKG), family history of certain||
1366|087|P|heart problems (QT prolongation in the EKG, sudden cardiac||
1366|088|P|death).||
1366|089|P|   Low levels of potassium or magnesium in the blood may also||
1366|090|P|increase your risk of QT prolongation. This risk may increase if||
1366|091|P|you use certain drugs (such as diuretics/"water pills") or if you||
1366|092|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1366|093|P|Talk to your doctor about using eribulin safely.||
1366|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1366|095|P|can make you more dizzy. Do not drive, use machinery, or do||
1366|096|P|anything that needs alertness until you can do it safely. Limit||
1366|097|P|alcoholic beverages. Talk to your doctor if you are using||
1366|098|P|marijuana (cannabis).||
1366|099|P|   Eribulin can make you more likely to get infections or may||
1366|100|P|make current infections worse. Stay away from anyone who has an||
1366|101|P|infection that may easily spread (such as chickenpox, COVID-19,||
1366|102|P|measles, flu). Talk to your doctor if you have been exposed to an||
1366|103|P|infection or for more details.||
1366|104|P|   Tell your health care professional that you are using eribulin||
1366|105|P|before having any immunizations/vaccinations. Avoid contact with||
1366|106|P|people who have recently received live vaccines (such as flu||
1366|107|P|vaccine inhaled through the nose).||
1366|108|P|   To lower the chance of getting cut, bruised, or injured, use||
1366|109|P|caution with sharp objects like razors and nail cutters, and||
1366|110|P|avoid activities such as contact sports.||
1366|111|P|   Before having surgery, tell your doctor or dentist about all||
1366|112|P|the products you use (including prescription drugs,||
1366|113|P|nonprescription drugs, and herbal products).||
1366|114|P|   Older adults may be more sensitive to the side effects of this||
1366|115|P|drug, especially QT prolongation (see above).||
1366|116|P|   Tell your doctor if you are pregnant or plan to become||
1366|117|P|pregnant. You should not become pregnant while using eribulin.||
1366|118|P|Eribulin may harm an unborn baby. Women using this medication||
1366|119|P|should ask about reliable forms of birth control during treatment||
1366|120|P|and for at least 2 weeks after the last dose. Men using this||
1366|121|P|medication should ask about reliable forms of birth control||
1366|122|P|during treatment and for 14 weeks after the last dose. If you or||
1366|123|P|your partner becomes pregnant, talk to your doctor right away||
1366|124|P|about the risks and benefits of this medication.||
1366|125|P|   It is unknown if this medication passes into breast milk.||
1366|126|P|Because of possible risk to the infant, breastfeeding is not||
1366|127|P|recommended while using this medication and for 2 weeks after the||
1366|128|P|last dose. Consult your doctor before breastfeeding.||
1366|129|B|||
1366|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1366|131|I|medications work or increase your risk for serious side effects.||
1366|132|I|This document does not contain all possible drug interactions.||
1366|133|I|Keep a list of all the products you use (including||
1366|134|I|prescription/nonprescription drugs and herbal products) and share||
1366|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
1366|136|I|the dosage of any medicines without your doctor's approval.||
1366|137|B|||
1366|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1366|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1366|140|O|poison control center right away. US residents can call||
1366|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1366|142|B|||
1366|143|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
1366|144|N|should be done while you are using this medication. Keep all||
1366|145|N|medical and lab appointments. Consult your doctor for more||
1366|146|N|details.||
1366|147|B|||
1366|148|D|MISSED DOSE:  It is important to get each dose of this medication||
1366|149|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1366|150|D|right away for a new dosing schedule.||
1366|151|B|||
1366|152|R|STORAGE:  Not applicable. This medication is given in a hospital||
1366|153|R|or clinic and will not be stored at home.||
1366|154|B|||
1366|155|A|Information last revised April 2025.||
1366|156|A|Copyright(c) 2025 First Databank, Inc.||
1366|157|B|||
1367|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1367|002|Z|does NOT have all possible information about this product. This||
1367|003|Z|information does not assure that this product is safe, effective,||
1367|004|Z|or appropriate for you. This information is not individual||
1367|005|Z|medical advice and does not substitute for the advice of your||
1367|006|Z|health care professional. Always ask your health care||
1367|007|Z|professional for complete information about this product and your||
1367|008|Z|specific health needs.||
1367|009|B|||
1367|010|T|RISEDRONATE DELAYED-RELEASE - ORAL||
1367|011|F|(RIS-e-DROE-nate)||
1367|012|B|||
1367|013|C|COMMON BRAND NAME(S): Atelvia||
1367|014|B|||
1367|015|U|USES:  Risedronate is used to prevent and treat certain types of||
1367|016|U|bone loss (osteoporosis) in adults. Osteoporosis causes bones to||
1367|017|U|become thinner and break more easily. Your chance of developing||
1367|018|U|osteoporosis increases as you age, after menopause, or if you are||
1367|019|U|taking corticosteroid medications (such as prednisone) for a long||
1367|020|U|time.||
1367|021|U|   This medication works by slowing bone loss. This effect helps||
1367|022|U|maintain strong bones and reduce the risk of broken bones||
1367|023|U|(fractures). Risedronate belongs to a class of medications called||
1367|024|U|bisphosphonates.||
1367|025|B|||
1367|026|H|HOW TO USE:  Read the Medication Guide, and if available, the||
1367|027|H|Patient Information Leaflet if available from your pharmacist||
1367|028|H|before you start taking risedronate and each time you get a||
1367|029|H|refill. If you have any questions, ask your doctor or pharmacist.||
1367|030|H|   Take this medication by mouth with or immediately after||
1367|031|H|breakfast as directed by your doctor, usually once a week. Choose||
1367|032|H|the day of the week that best fits your schedule and take it on||
1367|033|H|the same day every week. Do not take it at bedtime or while you||
1367|034|H|are still in bed.||
1367|035|H|   Take this medication with at least half a glass (4 ounces/120||
1367|036|H|milliliters) of plain water. Do not take it with any other||
1367|037|H|beverages. Swallow the tablet whole. Do not cut, crush, chew, or||
1367|038|H|suck on it. Then stay fully upright (sitting, standing or||
1367|039|H|walking) and do not lie down for at least 30 minutes.||
1367|040|H|   Calcium or iron supplements, vitamins that contain minerals,||
1367|041|H|and products that contain calcium/magnesium/aluminum (such as||
1367|042|H|antacids, laxatives) may interfere with absorption of||
1367|043|H|risedronate. Medications such as quinapril, sucralfate, and||
1367|044|H|bismuth subsalicylate may also interfere with absorption. Take||
1367|045|H|these products at a different time of the day from when you take||
1367|046|H|risedronate. Wait at least 30 minutes after taking risedronate||
1367|047|H|before you take these other products.||
1367|048|H|   Take this medication regularly to get the most benefit from||
1367|049|H|it. To help you remember, take it on the same day each week. Mark||
1367|050|H|your calendar with a reminder. Talk to your doctor about the||
1367|051|H|risks and benefits of long-term use of this medication.||
1367|052|B|||
1367|053|S|SIDE EFFECTS:  Stomach/abdominal pain, nausea, vomiting, or||
1367|054|S|diarrhea may occur. If any of these effects last or get worse,||
1367|055|S|tell your doctor or pharmacist promptly.||
1367|056|S|   Remember that this medication has been prescribed because your||
1367|057|S|doctor has judged that the benefit to you is greater than the||
1367|058|S|risk of side effects. Many people using this medication do not||
1367|059|S|have serious side effects.||
1367|060|S|   Tell your doctor right away if you have any serious side||
1367|061|S|effects, including: increased or severe bone/joint/muscle pain,||
1367|062|S|new or unusual hip/thigh/groin pain, jaw pain, eye/vision||
1367|063|S|problems.||
1367|064|S|   This medication may rarely cause irritation and ulcers in your||
1367|065|S|stomach or esophagus. Get medical help right away if any of these||
1367|066|S|serious side effects occur: new/severe/worsening heartburn, chest||
1367|067|S|pain, painful/difficult swallowing, severe stomach/abdominal||
1367|068|S|pain, black/tarry stools, vomit that looks like coffee grounds.||
1367|069|S|   A very serious allergic reaction to this drug is rare.||
1367|070|S|However, get medical help right away if you notice any symptoms||
1367|071|S|of a serious allergic reaction, including: rash, itching/swelling||
1367|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1367|073|S|breathing.||
1367|074|S|   This is not a complete list of possible side effects. If you||
1367|075|S|notice other effects not listed above, contact your doctor or||
1367|076|S|pharmacist.||
1367|077|S|   In the US -||
1367|078|S|   Call your doctor for medical advice about side effects. You||
1367|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1367|080|S|www.fda.gov/medwatch.||
1367|081|S|   In Canada - Call your doctor for medical advice about side||
1367|082|S|effects. You may report side effects to Health Canada at||
1367|083|S|1-866-234-2345.||
1367|084|B|||
1367|085|P|PRECAUTIONS:  Before taking risedronate, tell your doctor or||
1367|086|P|pharmacist if you are allergic to it; or if you have any other||
1367|087|P|allergies. This product may contain inactive ingredients, which||
1367|088|P|can cause allergic reactions or other problems. Talk to your||
1367|089|P|pharmacist for more details.||
1367|090|P|   Before using this medication, tell your doctor or pharmacist||
1367|091|P|your medical history, especially of: kidney disease, inability to||
1367|092|P|sit upright or stand for 30 minutes, low level of calcium in the||
1367|093|P|blood (hypocalcemia), disorders of the esophagus (such as||
1367|094|P|esophageal stricture or achalasia), difficult or painful||
1367|095|P|swallowing, stomach/intestinal disorders (such as ulcers).||
1367|096|P|   Some people taking risedronate may have serious jawbone||
1367|097|P|problems. Your doctor should check your mouth before you start||
1367|098|P|this medication. Tell your dentist that you are taking this||
1367|099|P|medication before you have any dental work done. To help prevent||
1367|100|P|jawbone problems, have regular dental exams and learn how to keep||
1367|101|P|your teeth and gums healthy. If you have jaw pain, tell your||
1367|102|P|doctor and dentist right away.||
1367|103|P|   Before having any surgery (especially dental procedures), tell||
1367|104|P|your doctor and dentist about this medication and all other||
1367|105|P|products you use (including prescription drugs, nonprescription||
1367|106|P|drugs, and herbal products). Your doctor or dentist may tell you||
1367|107|P|to stop taking risedronate before your surgery. Ask for specific||
1367|108|P|instructions about stopping or starting this medication.||
1367|109|P|   Tell your doctor if you are pregnant or plan to become||
1367|110|P|pregnant. Risedronate may stay in your body for many years. You||
1367|111|P|should not become pregnant while using risedronate. Discuss the||
1367|112|P|risks and benefits with your doctor.||
1367|113|P|   It is unknown if this medication passes into breast milk.||
1367|114|P|Consult your doctor before breastfeeding.||
1367|115|B|||
1367|116|I|DRUG INTERACTIONS:  See also How to Use section.||
1367|117|I|   Drug interactions may change how your medications work or||
1367|118|I|increase your risk for serious side effects. This document does||
1367|119|I|not contain all possible drug interactions. Keep a list of all||
1367|120|I|the products you use (including prescription/nonprescription||
1367|121|I|drugs and herbal products) and share it with your doctor and||
1367|122|I|pharmacist. Do not start, stop, or change the dosage of any||
1367|123|I|medicines without your doctor's approval.||
1367|124|I|   Products that may interact with this drug include: medications||
1367|125|I|that decrease stomach acid (such as antacids, H2 blockers||
1367|126|I|including ranitidine, proton pump inhibitors including||
1367|127|I|omeprazole).||
1367|128|I|   This medication may interfere with certain lab tests (such as||
1367|129|I|bone-imaging tests), possibly causing false test results. Make||
1367|130|I|sure lab personnel and all your doctors know you use this drug.||
1367|131|B|||
1367|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1367|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1367|134|O|poison control center right away. US residents can call||
1367|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1367|136|B|||
1367|137|N|NOTES:  Do not share this medication with others.||
1367|138|N|   Lifestyle changes that help promote healthy bones include||
1367|139|N|increasing weight-bearing exercise, stopping smoking, limiting||
1367|140|N|alcohol, and eating well-balanced meals that contain adequate||
1367|141|N|calcium and vitamin D. Since you may also need to take calcium||
1367|142|N|and vitamin D supplements and make lifestyle changes, consult||
1367|143|N|your doctor for specific advice.||
1367|144|N|   Lab and/or medical tests (such as x-rays, height, blood||
1367|145|N|mineral levels) should be done while you are taking this||
1367|146|N|medication. Keep all medical and lab appointments. Consult your||
1367|147|N|doctor for more details.||
1367|148|B|||
1367|149|D|MISSED DOSE:  If you miss a dose, do not take it later in the||
1367|150|D|day. Take it the next morning after you remember. Keep taking||
1367|151|D|your weekly dose on your originally scheduled day of the week. Do||
1367|152|D|not take two doses on the same day. Consult your doctor or||
1367|153|D|pharmacist if you have any questions.||
1367|154|B|||
1367|155|R|STORAGE:  Store at room temperature away from light and moisture.||
1367|156|R|Do not store in the bathroom. Keep all medications away from||
1367|157|R|children and pets.||
1367|158|R|   Do not flush medications down the toilet or pour them into a||
1367|159|R|drain unless instructed to do so. Properly discard this product||
1367|160|R|when it is expired or no longer needed. Consult your pharmacist||
1367|161|R|or local waste disposal company.||
1367|162|B|||
1367|163|A|Information last revised October 2024.||
1367|164|A|Copyright(c) 2025 First Databank, Inc.||
1367|165|B|||
1368|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1368|002|Z|does NOT have all possible information about this product. This||
1368|003|Z|information does not assure that this product is safe, effective,||
1368|004|Z|or appropriate for you. This information is not individual||
1368|005|Z|medical advice and does not substitute for the advice of your||
1368|006|Z|health care professional. Always ask your health care||
1368|007|Z|professional for complete information about this product and your||
1368|008|Z|specific health needs.||
1368|009|B|||
1368|010|T|DENOSUMAB 4 WEEK (120 MG) - INJECTION||
1368|011|F|(den-OH-sue-mab)||
1368|012|B|||
1368|013|C|COMMON BRAND NAME(S): Bilprevda, Bomyntra, Osenvelt, Wyost, Xgeva||
1368|014|B|||
1368|015|U|USES:  Denosumab is used to treat bone problems that may occur in||
1368|016|U|people with multiple myeloma or in people with cancer that has||
1368|017|U|spread to the bones. It is also used to treat high blood calcium||
1368|018|U|levels (hypercalcemia) that may occur with cancer. It may also be||
1368|019|U|used by adults (and teenagers who have reached their final adult||
1368|020|U|height) to treat a certain disease called giant cell tumor of the||
1368|021|U|bone, if they cannot use surgery to treat the disease.||
1368|022|U|   This monograph is about the following denosumab products:||
1368|023|U|denosumab, denosumab-bbdz, denosumab-bmwo, denosumab-bnht, and||
1368|024|U|denosumab-nxxp.||
1368|025|B|||
1368|026|H|HOW TO USE:  This medication is given by injection under the skin||
1368|027|H|in the upper arm, upper thigh, or abdomen by a healthcare||
1368|028|H|professional. It is given as directed by your doctor, usually||
1368|029|H|once every 4 weeks. If you are using this medication to treat||
1368|030|H|giant cell tumor of the bone or high blood calcium levels, your||
1368|031|H|doctor may also direct you to receive additional doses once a||
1368|032|H|week during weeks 2 and 3 of the first month of treatment.||
1368|033|H|   Use this medication regularly to get the most benefit from it.||
1368|034|H|To help you remember, mark your calendar with a reminder.||
1368|035|H|   You may also be instructed to take calcium and vitamin D||
1368|036|H|supplements. Follow your doctor's instructions carefully.||
1368|037|B|||
1368|038|S|SIDE EFFECTS:  Tiredness, weakness, headache, back pain,||
1368|039|S|diarrhea, and nausea may occur. If any of these effects last or||
1368|040|S|get worse, tell your doctor or pharmacist promptly.||
1368|041|S|   Remember that this medication has been prescribed because your||
1368|042|S|doctor has judged that the benefit to you is greater than the||
1368|043|S|risk of side effects. Many people using this medication do not||
1368|044|S|have serious side effects.||
1368|045|S|   Tell your doctor right away if you have any serious side||
1368|046|S|effects, including: jaw pain, new or unusual thigh/hip/groin||
1368|047|S|pain, bone/joint/muscle pain, shortness of breath.||
1368|048|S|   Denosumab may cause very serious (rarely fatal) low levels of||
1368|049|S|calcium in the blood, especially if you have kidney problems.||
1368|050|S|Take calcium and vitamin D as directed by your doctor. (See also||
1368|051|S|How to Use section.) Get medical help right away if you have any||
1368|052|S|symptoms of low calcium such as: severe muscle spasms/cramps,||
1368|053|S|mental/mood changes (such as irritability or confusion),||
1368|054|S|numbness/tingling (especially around lips/mouth or in||
1368|055|S|fingers/toes), seizures, severe dizziness/fainting,||
1368|056|S|fast/irregular heartbeat.||
1368|057|S|   Denosumab can affect your immune system. You may be more||
1368|058|S|likely to get a serious infection, such as a skin, ear,||
1368|059|S|stomach/gut, or bladder infection. Tell your doctor right away if||
1368|060|S|you develop any signs of infection, such as: fever/chills,||
1368|061|S|red/swollen/tender/warm skin (with or without pus), severe||
1368|062|S|abdominal pain, ear pain/discharge, trouble hearing,||
1368|063|S|frequent/painful/burning urination, pink/bloody urine.||
1368|064|S|   Denosumab can cause skin problems such as dryness, peeling,||
1368|065|S|redness, itching, small bumps/patches, or blisters. However, you||
1368|066|S|may not be able to tell it apart from a rare rash that could be a||
1368|067|S|sign of a severe allergic reaction. Get medical help right away||
1368|068|S|if you develop any rash or if any of these symptoms last or get||
1368|069|S|worse.||
1368|070|S|   Denosumab may cause high levels of calcium in the blood weeks||
1368|071|S|to months after treatment has stopped, especially if you have not||
1368|072|S|reached your final adult height. Tell your doctor right away if||
1368|073|S|you have any symptoms of high calcium after you have stopped||
1368|074|S|using denosumab such as: nausea, vomiting, headache, unusual||
1368|075|S|tiredness.||
1368|076|S|   After your treatment with denosumab is stopped, you may be at||
1368|077|S|increased risk for bone fractures in your spine. This risk is||
1368|078|S|greater if you have bone loss (osteoporosis) or have had broken||
1368|079|S|bones. If your treatment is stopped, talk with your doctor about||
1368|080|S|other medicines you can take.||
1368|081|S|   A very serious allergic reaction to this drug is rare.||
1368|082|S|However, get medical help right away if you notice any symptoms||
1368|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1368|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1368|085|S|breathing.||
1368|086|S|   This is not a complete list of possible side effects. If you||
1368|087|S|notice other effects not listed above, contact your doctor or||
1368|088|S|pharmacist.||
1368|089|S|   In the US -||
1368|090|S|   Call your doctor for medical advice about side effects. You||
1368|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1368|092|S|www.fda.gov/medwatch.||
1368|093|S|   In Canada - Call your doctor for medical advice about side||
1368|094|S|effects. You may report side effects to Health Canada at||
1368|095|S|1-866-234-2345.||
1368|096|B|||
1368|097|P|PRECAUTIONS:  Before using denosumab, tell your doctor or||
1368|098|P|pharmacist if you are allergic to it; or to other denosumab||
1368|099|P|products; or if you have any other allergies. This product may||
1368|100|P|contain inactive ingredients, which can cause allergic reactions||
1368|101|P|or other problems. Talk to your pharmacist for more details.||
1368|102|P|   Before using this medication, tell your doctor or pharmacist||
1368|103|P|your medical history, especially of: low level of calcium in the||
1368|104|P|blood (hypocalcemia), kidney disease.||
1368|105|P|   Some people using denosumab may have serious jawbone problems.||
1368|106|P|Your doctor should check your mouth before you start this||
1368|107|P|medication. Tell your dentist that you are using this medication||
1368|108|P|before you have any dental work done. To help prevent jawbone||
1368|109|P|problems, have regular dental exams and learn how to keep your||
1368|110|P|teeth and gums healthy. If you have jaw pain, tell your doctor||
1368|111|P|and dentist right away.||
1368|112|P|   Before having any surgery (especially dental procedures), tell||
1368|113|P|your doctor and dentist about this medication and all other||
1368|114|P|products you use (including prescription drugs, nonprescription||
1368|115|P|drugs, and herbal products).||
1368|116|P|   Denosumab is not recommended for use in children except for||
1368|117|P|the treatment of giant cell tumor of the bone (see also Uses||
1368|118|P|section). It may slow down a child's growth and affect tooth||
1368|119|P|development.||
1368|120|P|   Tell your doctor if you are pregnant or plan to become||
1368|121|P|pregnant. You should not become pregnant while using denosumab.||
1368|122|P|Denosumab may harm an unborn baby. Your doctor should order a||
1368|123|P|pregnancy test before you start this medication. Ask about||
1368|124|P|reliable forms of birth control while using this medication and||
1368|125|P|for 5 months after the last dose. If you become pregnant, talk to||
1368|126|P|your doctor right away about the risks and benefits of this||
1368|127|P|medication.||
1368|128|P|   It is unknown if this medication passes into breast milk.||
1368|129|P|Consult your doctor before breastfeeding.||
1368|130|B|||
1368|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1368|132|I|medications work or increase your risk for serious side effects.||
1368|133|I|This document does not contain all possible drug interactions.||
1368|134|I|Keep a list of all the products you use (including||
1368|135|I|prescription/nonprescription drugs and herbal products) and share||
1368|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
1368|137|I|the dosage of any medicines without your doctor's approval.||
1368|138|B|||
1368|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1368|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1368|141|O|poison control center right away. US residents can call||
1368|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1368|143|B|||
1368|144|N|NOTES:  Lab and/or medical tests (such as calcium/phosphorus||
1368|145|N|levels, kidney function) should be done while you are using this||
1368|146|N|medication. Keep all medical and lab appointments. Consult your||
1368|147|N|doctor for more details.||
1368|148|N|   Do not take this medication with any other product that||
1368|149|N|contains denosumab.||
1368|150|B|||
1368|151|D|MISSED DOSE:  It is important to get each dose of this medication||
1368|152|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1368|153|D|right away for a new dosing schedule.||
1368|154|B|||
1368|155|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1368|156|R|doctor's office and will not be stored at home.||
1368|157|R|   Do not flush medications down the toilet or pour them into a||
1368|158|R|drain unless instructed to do so. Properly discard this product||
1368|159|R|when it is expired or no longer needed. Consult your pharmacist||
1368|160|R|or local waste disposal company.||
1368|161|B|||
1368|162|A|Information last revised September 2025.||
1368|163|A|Copyright(c) 2025 First Databank, Inc.||
1368|164|B|||
1370|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1370|002|Z|does NOT have all possible information about this product. This||
1370|003|Z|information does not assure that this product is safe, effective,||
1370|004|Z|or appropriate for you. This information is not individual||
1370|005|Z|medical advice and does not substitute for the advice of your||
1370|006|Z|health care professional. Always ask your health care||
1370|007|Z|professional for complete information about this product and your||
1370|008|Z|specific health needs.||
1370|009|B|||
1370|010|T|CEFTAROLINE - INJECTION||
1370|011|F|(sef-TAR-oh-leen)||
1370|012|B|||
1370|013|C|COMMON BRAND NAME(S): Teflaro||
1370|014|B|||
1370|015|U|USES:  Ceftaroline is an antibiotic used to treat a variety of||
1370|016|U|bacterial infections. This medication is known as a cephalosporin||
1370|017|U|antibiotic. It works by stopping the growth of bacteria.||
1370|018|B|||
1370|019|H|HOW TO USE:  This medication is given by injection into a vein as||
1370|020|H|directed by your doctor, usually every 8 or 12 hours. The dosage||
1370|021|H|is based on your medical condition and response to treatment.||
1370|022|H|Children's dosage is also based on age and weight.||
1370|023|H|   If you are using this medication at home, learn all||
1370|024|H|preparation and usage instructions from your health care||
1370|025|H|professional. Before using, check this product for particles or||
1370|026|H|discoloration. If either is present, do not use the liquid. Learn||
1370|027|H|how to store and discard medical supplies safely.||
1370|028|H|   For the best effect, use this antibiotic at evenly spaced||
1370|029|H|times. To help you remember, use this medication at the same||
1370|030|H|time(s) every day.||
1370|031|H|   Continue to use this medication for the full time prescribed,||
1370|032|H|even if symptoms disappear after a few days. Stopping the||
1370|033|H|medication too early may result in a return of the infection.||
1370|034|H|   Tell your doctor if your condition lasts or gets worse.||
1370|035|B|||
1370|036|S|SIDE EFFECTS:  Pain, redness, or swelling at the injection site||
1370|037|S|may occur. Nausea or diarrhea may also occur. If any of these||
1370|038|S|effects last or get worse, tell your doctor or pharmacist||
1370|039|S|promptly.||
1370|040|S|   Remember that this medication has been prescribed because your||
1370|041|S|doctor has judged that the benefit to you is greater than the||
1370|042|S|risk of side effects. Many people using this medication do not||
1370|043|S|have serious side effects.||
1370|044|S|   Tell your doctor right away if you have any serious side||
1370|045|S|effects, including: mental/mood changes (such as confusion),||
1370|046|S|seizures.||
1370|047|S|   This medication may rarely cause a severe intestinal condition||
1370|048|S|due to a bacteria called C. difficile. This condition may occur||
1370|049|S|during treatment or weeks to months after treatment has stopped.||
1370|050|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1370|051|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1370|052|S|stool.||
1370|053|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1370|054|S|products because they may make symptoms worse.||
1370|055|S|   Use of this medication for prolonged or repeated periods may||
1370|056|S|result in oral thrush or a new vaginal yeast infection. Contact||
1370|057|S|your doctor if you notice white patches in your mouth, a change||
1370|058|S|in vaginal discharge, or other new symptoms.||
1370|059|S|   A very serious allergic reaction to this drug is rare.||
1370|060|S|However, get medical help right away if you notice any symptoms||
1370|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1370|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1370|063|S|breathing.||
1370|064|S|   This is not a complete list of possible side effects. If you||
1370|065|S|notice other effects not listed above, contact your doctor or||
1370|066|S|pharmacist.||
1370|067|S|   In the US -||
1370|068|S|   Call your doctor for medical advice about side effects. You||
1370|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1370|070|S|www.fda.gov/medwatch.||
1370|071|S|   In Canada - Call your doctor for medical advice about side||
1370|072|S|effects. You may report side effects to Health Canada at||
1370|073|S|1-866-234-2345.||
1370|074|B|||
1370|075|P|PRECAUTIONS:  Before using ceftaroline, tell your doctor or||
1370|076|P|pharmacist if you are allergic to it; or to other cephalosporins;||
1370|077|P|or to penicillins; or if you have any other allergies. This||
1370|078|P|product may contain inactive ingredients, which can cause||
1370|079|P|allergic reactions or other problems. Talk to your pharmacist for||
1370|080|P|more details.||
1370|081|P|   Before using this medication, tell your doctor or pharmacist||
1370|082|P|your medical history, especially of: kidney disease.||
1370|083|P|   Ceftaroline may cause live bacterial vaccines (such as typhoid||
1370|084|P|vaccine) to not work well. Tell your health care professional||
1370|085|P|that you are using ceftaroline before having any||
1370|086|P|immunizations/vaccinations.||
1370|087|P|   Before having surgery, tell your doctor or dentist about all||
1370|088|P|the products you use (including prescription drugs,||
1370|089|P|nonprescription drugs, and herbal products).||
1370|090|P|   Tell your doctor if you are pregnant before using this||
1370|091|P|medication.||
1370|092|P|   It is unknown if this medication passes into breast milk.||
1370|093|P|Consult your doctor before breastfeeding.||
1370|094|B|||
1370|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1370|096|I|medications work or increase your risk for serious side effects.||
1370|097|I|This document does not contain all possible drug interactions.||
1370|098|I|Keep a list of all the products you use (including||
1370|099|I|prescription/nonprescription drugs and herbal products) and share||
1370|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
1370|101|I|the dosage of any medicines without your doctor's approval.||
1370|102|I|   This medication may interfere with certain medical/lab tests||
1370|103|I|(such as Coombs' test, urine glucose tests), possibly causing||
1370|104|I|false test results. Make sure lab personnel and all your doctors||
1370|105|I|know you use this drug.||
1370|106|B|||
1370|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1370|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1370|109|O|poison control center right away. US residents can call||
1370|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1370|111|B|||
1370|112|N|NOTES:  Lab and/or medical tests (such as kidney function) may be||
1370|113|N|done while you are using this medication. Keep all medical and||
1370|114|N|lab appointments. Consult your doctor for more details.||
1370|115|B|||
1370|116|D|MISSED DOSE:  It is important to get each dose of this medication||
1370|117|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1370|118|D|right away for a new dosing schedule. Do not double the dose to||
1370|119|D|catch up.||
1370|120|B|||
1370|121|R|STORAGE:  Consult the product instructions and your pharmacist||
1370|122|R|for storage details. Keep all medications away from children and||
1370|123|R|pets.||
1370|124|R|   Do not flush medications down the toilet or pour them into a||
1370|125|R|drain unless instructed to do so. Properly discard this product||
1370|126|R|when it is expired or no longer needed. Consult your pharmacist||
1370|127|R|or local waste disposal company.||
1370|128|B|||
1370|129|A|Information last revised November 2024.||
1370|130|A|Copyright(c) 2025 First Databank, Inc.||
1370|131|B|||
1371|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1371|002|Z|does NOT have all possible information about this product. This||
1371|003|Z|information does not assure that this product is safe, effective,||
1371|004|Z|or appropriate for you. This information is not individual||
1371|005|Z|medical advice and does not substitute for the advice of your||
1371|006|Z|health care professional. Always ask your health care||
1371|007|Z|professional for complete information about this product and your||
1371|008|Z|specific health needs.||
1371|009|B|||
1371|010|T|NORETHINDRONE/ETHINYL ESTRADIOL/FERROUS FUMARATE 24/2/2 - ORAL||
1371|011|F|(nor-ETH-in-drone/ETH-i-nil ES-tra-DYE-ol/FER-us FUE-ma-rate)||
1371|012|B|||
1371|013|C|COMMON BRAND NAME(S): Lo Loestrin Fe||
1371|014|B|||
1371|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
1371|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
1371|017|W|stroke, heart attack, blood clots, and high blood pressure from||
1371|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
1371|019|W|of these serious problems increases with age and with the number||
1371|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
1371|021|W|   Accidental overdose of iron-containing products is a leading||
1371|022|W|cause of fatal poisoning in children under 6 years of age. Keep||
1371|023|W|this product out of reach of children. If overdose occurs, get||
1371|024|W|medical help right away or call a poison control center.||
1371|025|B|||
1371|026|U|USES:  This combination hormone medication is used to prevent||
1371|027|U|pregnancy. It contains 2 hormones: norethindrone (a progestin)||
1371|028|U|and ethinyl estradiol (an estrogen).||
1371|029|U|   This product also contains a small amount of iron (ferrous||
1371|030|U|fumarate) in inactive tablets taken during the fourth week. The||
1371|031|U|inactive pills do not contain any hormones. These tablets are||
1371|032|U|meant to keep you in the habit of taking 1 tablet each day and do||
1371|033|U|not have enough iron to treat iron deficiency.||
1371|034|U|   Besides preventing pregnancy, birth control pills may make||
1371|035|U|your periods more regular, decrease blood loss and painful||
1371|036|U|periods, decrease the risk of ovarian cysts, and also treat acne.||
1371|037|U|   This medication does not protect against sexually transmitted||
1371|038|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1371|039|U|an effective barrier method (latex or polyurethane condom/dental||
1371|040|U|dams) during sexual activity will help to decrease your risk of||
1371|041|U|infection.||
1371|042|B|||
1371|043|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1371|044|H|your pharmacist before you start taking this product and each||
1371|045|H|time you get a refill. The leaflet contains very important||
1371|046|H|information on when to take your pills and what to do if you miss||
1371|047|H|a dose. If you have any questions, ask your doctor or pharmacist.||
1371|048|H|   Take this medication by mouth with or without food as directed||
1371|049|H|by your doctor, usually once daily. Pick a time of day that is||
1371|050|H|easy for you to remember, and take your pill at the same time||
1371|051|H|each day.||
1371|052|H|   It is very important to keep taking this medication exactly as||
1371|053|H|prescribed by your doctor. With certain brands of birth control||
1371|054|H|pills, the amount of estrogen and progestin in each active tablet||
1371|055|H|will vary at different times in the cycle. Follow the package||
1371|056|H|instructions to find the first tablet, start with the first||
1371|057|H|tablet in the pack, and take them in the correct order. Do not||
1371|058|H|skip any doses. Pregnancy is more likely if you miss pills, start||
1371|059|H|a new pack late, or take your pill at a different time of the day||
1371|060|H|than usual.||
1371|061|H|   If you have vomiting or diarrhea within 3 to 4 hours after||
1371|062|H|taking your tablet, read the Patient Information Leaflet section||
1371|063|H|titled "What to Do if You Miss Tablets." Follow the instructions||
1371|064|H|as if you had missed your dose because vomiting/diarrhea can stop||
1371|065|H|the tablet from working.||
1371|066|H|   Taking this medication after your evening meal or at bedtime||
1371|067|H|may help if you have stomach upset or nausea with the medication.||
1371|068|H|You may choose to take this medication at another time of day||
1371|069|H|that is easier for you to remember. No matter what dosing||
1371|070|H|schedule you use, it is very important that you take this||
1371|071|H|medication at the same time each day, 24 hours apart.||
1371|072|H|   Your pill pack contains 26 pills with active medication (24||
1371|073|H|pills with norethindrone and ethinyl estradiol, 2 pills with only||
1371|074|H|ethinyl estradiol). It also contains 2 reminder pills with iron.||
1371|075|H|Take one active pill (with hormones) once daily for 26 days in a||
1371|076|H|row. After you have taken the last active pill, take one reminder||
1371|077|H|pill (with iron) once daily for 2 days in a row unless otherwise||
1371|078|H|directed by your doctor. You should have your period during the||
1371|079|H|fourth week of the cycle. After you have taken the last reminder||
1371|080|H|tablet in the pack, start a new pack the next day even if your||
1371|081|H|period is continuing or if you do not have your period. If you do||
1371|082|H|not get your period, consult your doctor.||
1371|083|H|   If this is the first time you are using this medication and||
1371|084|H|you are not switching from another form of hormonal birth control||
1371|085|H|(such as patch, other birth control pills), take the first tablet||
1371|086|H|in the pack on the first Sunday following the beginning of your||
1371|087|H|menstrual period or on the first day of your period. If your||
1371|088|H|period begins on a Sunday, begin taking this medication on that||
1371|089|H|day. For the first cycle of use only, use a backup form of||
1371|090|H|non-hormonal birth control (such as condoms, spermicide) for the||
1371|091|H|first 7 days to prevent pregnancy until the medication has enough||
1371|092|H|time to work. If you start on the first day of your period, you||
1371|093|H|do not need to use backup birth control the first week.||
1371|094|H|   Ask your doctor or pharmacist for information about how to||
1371|095|H|switch from other forms of hormonal birth control (such as patch,||
1371|096|H|other birth control pills) to this product. If any information is||
1371|097|H|unclear, consult the Patient Information Leaflet or your doctor||
1371|098|H|or pharmacist.||
1371|099|B|||
1371|100|S|SIDE EFFECTS:  Nausea, vomiting, headache, abdominal||
1371|101|S|cramps/bloating, breast tenderness, swelling of the ankles/feet||
1371|102|S|(retaining fluid), or weight change may occur. Vaginal bleeding||
1371|103|S|between periods (spotting) or missed/irregular periods may occur,||
1371|104|S|especially during the first few months of use. If any of these||
1371|105|S|effects last or get worse, tell your doctor or pharmacist||
1371|106|S|promptly. If you miss 2 periods in a row (or 1 period if the pill||
1371|107|S|has not been used properly), contact your doctor for a pregnancy||
1371|108|S|test.||
1371|109|S|   Remember that this medication has been prescribed because your||
1371|110|S|doctor has judged that the benefit to you is greater than the||
1371|111|S|risk of side effects. Many people using this medication do not||
1371|112|S|have serious side effects.||
1371|113|S|   This medication may raise your blood pressure. Check your||
1371|114|S|blood pressure regularly and tell your doctor if the results are||
1371|115|S|high.||
1371|116|S|   Tell your doctor right away if you have any serious side||
1371|117|S|effects, including: a lump in your breast, mental/mood changes||
1371|118|S|(such as new/worsening depression), unusual changes in vaginal||
1371|119|S|bleeding (such as continuous spotting, sudden heavy bleeding),||
1371|120|S|dark urine, severe stomach/abdominal pain, yellowing eyes/skin.||
1371|121|S|   This medication may rarely cause serious (sometimes fatal)||
1371|122|S|problems from blood clots (such as heart attack, stroke, blood||
1371|123|S|clots in the lungs or legs). Get medical help right away if you||
1371|124|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1371|125|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
1371|126|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1371|127|S|trouble speaking, weakness on one side of the body, sudden vision||
1371|128|S|changes.||
1371|129|S|   A very serious allergic reaction to this drug is rare.||
1371|130|S|However, get medical help right away if you notice any symptoms||
1371|131|S|of a serious allergic reaction, including: rash, itching/swelling||
1371|132|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1371|133|S|breathing.||
1371|134|S|   This is not a complete list of possible side effects. If you||
1371|135|S|notice other effects not listed above, contact your doctor or||
1371|136|S|pharmacist.||
1371|137|S|   In the US -||
1371|138|S|   Call your doctor for medical advice about side effects. You||
1371|139|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1371|140|S|www.fda.gov/medwatch.||
1371|141|S|   In Canada - Call your doctor for medical advice about side||
1371|142|S|effects. You may report side effects to Health Canada at||
1371|143|S|1-866-234-2345.||
1371|144|B|||
1371|145|P|PRECAUTIONS:  See also Warning section.||
1371|146|P|   Before using this medication, tell your doctor or pharmacist||
1371|147|P|if you are allergic to estradiol or norethindrone or iron; or to||
1371|148|P|any estrogens (such as mestranol) or any progestins (such as||
1371|149|P|desogestrel); or if you have any other allergies. This product||
1371|150|P|may contain inactive ingredients, which can cause allergic||
1371|151|P|reactions or other problems. Talk to your pharmacist for more||
1371|152|P|details.||
1371|153|P|   Before using this product, tell your doctor or pharmacist your||
1371|154|P|medical history, especially of: blood clots (for example, in the||
1371|155|P|legs, eyes, lungs), blood clotting disorders (such as protein C||
1371|156|P|or protein S deficiency), high blood pressure, abnormal breast||
1371|157|P|exam, cancer (especially breast or endometrial cancer), high||
1371|158|P|cholesterol or triglyceride (blood fat) levels, depression,||
1371|159|P|diabetes, family or personal history of a certain swelling||
1371|160|P|disorder (angioedema), gallbladder problems, severe||
1371|161|P|headaches/migraines, heart problems (such as heart valve disease,||
1371|162|P|irregular heartbeat, previous heart attack), history of yellowing||
1371|163|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
1371|164|P|birth control (such as pills, patch), kidney disease, liver||
1371|165|P|disease (including tumors), stroke, swelling (edema), thyroid||
1371|166|P|problems, unexplained vaginal bleeding, obesity.||
1371|167|P|   If you have diabetes, this medication may affect your blood||
1371|168|P|sugar. Check your blood sugar regularly as directed and share the||
1371|169|P|results with your doctor. Tell your doctor right away if you have||
1371|170|P|symptoms of high blood sugar such as increased thirst/urination.||
1371|171|P|Your doctor may need to adjust your diabetes medication, exercise||
1371|172|P|program, or diet.||
1371|173|P|   Tell your doctor if you just had or will be having surgery or||
1371|174|P|if you will be confined to a bed or chair for a long time (such||
1371|175|P|as on a long plane flight). These conditions increase your risk||
1371|176|P|of getting blood clots, especially if you are using hormonal||
1371|177|P|birth control. You may need to stop this medication for a time or||
1371|178|P|take special precautions.||
1371|179|P|   Before having surgery, tell your doctor or dentist about all||
1371|180|P|the products you use (including prescription drugs,||
1371|181|P|nonprescription drugs, and herbal products).||
1371|182|P|   This medication may cause blotchy, dark areas on your face and||
1371|183|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
1371|184|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
1371|185|P|wear protective clothing when outdoors.||
1371|186|P|   If you are nearsighted or wear contact lenses, you may develop||
1371|187|P|vision problems or trouble wearing your contact lenses. Contact||
1371|188|P|your eye doctor if these problems occur.||
1371|189|P|   It may take longer for you to become pregnant after you stop||
1371|190|P|taking birth control pills. Consult your doctor.||
1371|191|P|   This medication should not be used during pregnancy. If you||
1371|192|P|become pregnant or think you may be pregnant, tell your doctor||
1371|193|P|right away. If you have just given birth or had a pregnancy||
1371|194|P|loss/abortion after the first 3 months, talk with your doctor||
1371|195|P|about reliable forms of birth control, and find out when it is||
1371|196|P|safe to start using birth control that contains a form of||
1371|197|P|estrogen, such as this medication.||
1371|198|P|   A small amount of this medication passes into breast milk and||
1371|199|P|may have undesirable effects on a nursing infant. Consult your||
1371|200|P|doctor before breastfeeding.||
1371|201|B|||
1371|202|I|DRUG INTERACTIONS:  See also How to Use section.||
1371|203|I|   Drug interactions may change how your medications work or||
1371|204|I|increase your risk for serious side effects. This document does||
1371|205|I|not contain all possible drug interactions. Keep a list of all||
1371|206|I|the products you use (including prescription/nonprescription||
1371|207|I|drugs and herbal products) and share it with your doctor and||
1371|208|I|pharmacist. Do not start, stop, or change the dosage of any||
1371|209|I|medicines without your doctor's approval.||
1371|210|I|   Some products that may interact with this drug include:||
1371|211|I|aromatase inhibitors (such as anastrozole, exemestane,||
1371|212|I|letrozole), dimercaprol, fezolinetant, ospemifene, tamoxifen,||
1371|213|I|tranexamic acid.||
1371|214|I|   Some drugs may cause hormonal birth control to work less well||
1371|215|I|by decreasing the amount of birth control hormones in your body.||
1371|216|I|This effect can result in pregnancy. Examples include||
1371|217|I|griseofulvin, modafinil, rifamycins (such as rifampin),||
1371|218|I|ritonavir, St. John's wort, drugs used to treat seizures (such as||
1371|219|I|barbiturates, carbamazepine, felbamate, phenytoin, primidone,||
1371|220|I|topiramate), HIV drugs (such as nelfinavir, nevirapine), among||
1371|221|I|others.||
1371|222|I|   Tell your doctor when you start any new drug, and discuss if||
1371|223|I|you should use reliable backup birth control. Also tell your||
1371|224|I|doctor if you have any new spotting or breakthrough bleeding,||
1371|225|I|because these may be signs that your birth control is not working||
1371|226|I|well.||
1371|227|I|   The iron in the inactive pill can decrease the absorption of||
1371|228|I|certain drugs, especially if you take them around the same time.||
1371|229|I|These drugs include bisphosphonates (such as alendronate),||
1371|230|I|levodopa, penicillamine, quinolone antibiotics (such as||
1371|231|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
1371|232|I|doxycycline, minocycline), thyroid medications (such as||
1371|233|I|levothyroxine), among others. Ask your doctor or pharmacist if||
1371|234|I|you should throw away the inactive pills (iron tablets) each day||
1371|235|I|rather than taking them.||
1371|236|I|   This medication may interfere with certain lab tests (such as||
1371|237|I|blood tests for clotting factors, thyroid), possibly causing||
1371|238|I|false test results. Make sure lab personnel and all your doctors||
1371|239|I|know you use this drug.||
1371|240|B|||
1371|241|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1371|242|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1371|243|O|poison control center right away. US residents can call||
1371|244|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1371|245|O|Symptoms of overdose may include: severe nausea and vomiting,||
1371|246|O|sudden/unusual vaginal bleeding.||
1371|247|B|||
1371|248|N|NOTES:  Do not share this medication with others.||
1371|249|N|   Regular complete physical exams which include lab and/or||
1371|250|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
1371|251|N|Pap smear) should be done while you are taking this medication.||
1371|252|N|Follow your doctor's instructions for examining your breasts, and||
1371|253|N|report any lumps right away. Keep all medical and lab||
1371|254|N|appointments. Consult your doctor for more details.||
1371|255|B|||
1371|256|D|MISSED DOSE:  Missed dose advice is different depending on the||
1371|257|D|brand used and the number of doses missed. Refer to the product||
1371|258|D|package information for advice on missed doses. You may need to||
1371|259|D|use backup birth control (such as condoms, spermicide) to prevent||
1371|260|D|pregnancy. Ask your doctor or pharmacist if you have any||
1371|261|D|questions.||
1371|262|D|   If you often forget to take your pills as directed, contact||
1371|263|D|your doctor to discuss switching to another form of birth||
1371|264|D|control.||
1371|265|B|||
1371|266|R|STORAGE:  Store at room temperature away from light and moisture.||
1371|267|R|Do not store in the bathroom. Keep all medications away from||
1371|268|R|children and pets.||
1371|269|R|   Do not flush medications down the toilet or pour them into a||
1371|270|R|drain unless instructed to do so. Properly discard this product||
1371|271|R|when it is expired or no longer needed. Consult your pharmacist||
1371|272|R|or local waste disposal company.||
1371|273|B|||
1371|274|A|Information last revised October 2025.||
1371|275|A|Copyright(c) 2025 First Databank, Inc.||
1371|276|B|||
1372|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1372|002|Z|does NOT have all possible information about this product. This||
1372|003|Z|information does not assure that this product is safe, effective,||
1372|004|Z|or appropriate for you. This information is not individual||
1372|005|Z|medical advice and does not substitute for the advice of your||
1372|006|Z|health care professional. Always ask your health care||
1372|007|Z|professional for complete information about this product and your||
1372|008|Z|specific health needs.||
1372|009|B|||
1372|010|T|ULIPRISTAL - ORAL||
1372|011|F|(UE-li-PRIS-tal)||
1372|012|B|||
1372|013|C|COMMON BRAND NAME(S): Ella||
1372|014|B|||
1372|015|U|USES:  Ulipristal is used by women to prevent pregnancy after||
1372|016|U|birth control failure (such as a broken condom) or unprotected||
1372|017|U|sex. This medication is an emergency contraceptive and should not||
1372|018|U|be used as a regular form of birth control.||
1372|019|U|   Using this medication will not stop an existing pregnancy or||
1372|020|U|protect you or your partner against sexually transmitted diseases||
1372|021|U|(such as HIV, gonorrhea, chlamydia).||
1372|022|U|   This medication may not work well in women who are overweight||
1372|023|U|(for example, body mass index greater than 30) or if you are||
1372|024|U|using certain other medications. This effect can result in||
1372|025|U|pregnancy. Talk to your doctor for more details and to see if||
1372|026|U|this medication is right for you (see also Drug Interactions||
1372|027|U|section).||
1372|028|B|||
1372|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1372|030|H|from your pharmacist before you start taking ulipristal. If you||
1372|031|H|have any questions, ask your doctor or pharmacist.||
1372|032|H|   Take 1 tablet by mouth with or without food as directed by||
1372|033|H|your doctor as soon as possible after unprotected sex. This||
1372|034|H|medication works best when it is taken within 120 hours (5 days)||
1372|035|H|after unprotected sex.||
1372|036|H|   If you vomit within 3 hours of taking this medication, contact||
1372|037|H|your doctor to ask if you need to repeat the dose.||
1372|038|H|   After you take this medication, the time when your period||
1372|039|H|comes and how much you bleed may change. Tell your doctor right||
1372|040|H|away if your period is more than 7 days late. You may need to||
1372|041|H|take a pregnancy test.||
1372|042|H|   After using this medication, you should use a barrier-type||
1372|043|H|birth control (such as condoms, diaphragm) every time you have||
1372|044|H|sex until you have your period. If you use or wish to use||
1372|045|H|hormonal birth control, wait at least 5 days after using this||
1372|046|H|medication before starting hormonal birth control (since these||
1372|047|H|medications may interact and make both drugs work less well).||
1372|048|H|After starting hormonal birth control, continue to use a||
1372|049|H|barrier-type birth control every time you have sex until you have||
1372|050|H|your period. If needed, talk to your doctor about reliable forms||
1372|051|H|of birth control.||
1372|052|B|||
1372|053|S|SIDE EFFECTS:  Headache, nausea, abdominal pain, tiredness,||
1372|054|S|dizziness, or painful menstrual periods may occur. If any of||
1372|055|S|these effects last or get worse, tell your doctor or pharmacist||
1372|056|S|promptly.||
1372|057|S|   Remember that this medication has been prescribed because your||
1372|058|S|doctor has judged that the benefit to you is greater than the||
1372|059|S|risk of side effects. Many people using this medication do not||
1372|060|S|have serious side effects.||
1372|061|S|   Tell your doctor right away if you have any serious side||
1372|062|S|effects, including: severe lower stomach pain (especially 3 to 5||
1372|063|S|weeks after taking ulipristal).||
1372|064|S|   A very serious allergic reaction to this drug is rare.||
1372|065|S|However, get medical help right away if you notice any symptoms||
1372|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1372|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1372|068|S|breathing.||
1372|069|S|   This is not a complete list of possible side effects. If you||
1372|070|S|notice other effects not listed above, contact your doctor or||
1372|071|S|pharmacist.||
1372|072|S|   In the US -||
1372|073|S|   Call your doctor for medical advice about side effects. You||
1372|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1372|075|S|www.fda.gov/medwatch.||
1372|076|S|   In Canada - Call your doctor for medical advice about side||
1372|077|S|effects. You may report side effects to Health Canada at||
1372|078|S|1-866-234-2345.||
1372|079|B|||
1372|080|P|PRECAUTIONS:  Before taking ulipristal, tell your doctor or||
1372|081|P|pharmacist if you are allergic to it; or to progestins (such as||
1372|082|P|levonorgestrel, norethindrone); or if you have any other||
1372|083|P|allergies. This product may contain inactive ingredients, which||
1372|084|P|can cause allergic reactions or other problems. Talk to your||
1372|085|P|pharmacist for more details.||
1372|086|P|   Before using this medication, tell your doctor or pharmacist||
1372|087|P|your medical history, especially of: unexplained vaginal||
1372|088|P|bleeding.||
1372|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1372|090|P|can make you more dizzy. Do not drive, use machinery, or do||
1372|091|P|anything that needs alertness until you can do it safely. Limit||
1372|092|P|alcoholic beverages. Talk to your doctor if you are using||
1372|093|P|marijuana (cannabis).||
1372|094|P|   Before having surgery, tell your doctor or dentist about all||
1372|095|P|the products you use (including prescription drugs,||
1372|096|P|nonprescription drugs, and herbal products).||
1372|097|P|   This medication must not be used during pregnancy. If you||
1372|098|P|become pregnant or think you may be pregnant, tell your doctor||
1372|099|P|right away.||
1372|100|P|   This drug passes into breast milk. Because of the possible||
1372|101|P|risk to the infant, breastfeeding is not recommended while using||
1372|102|P|this drug. Consult your doctor before breastfeeding.||
1372|103|B|||
1372|104|I|DRUG INTERACTIONS:  See also How to Use section.||
1372|105|I|   Drug interactions may change how your medications work or||
1372|106|I|increase your risk for serious side effects. This document does||
1372|107|I|not contain all possible drug interactions. Keep a list of all||
1372|108|I|the products you use (including prescription/nonprescription||
1372|109|I|drugs and herbal products) and share it with your doctor and||
1372|110|I|pharmacist. Do not start, stop, or change the dosage of any||
1372|111|I|medicines without your doctor's approval.||
1372|112|I|   Some drugs may cause emergency birth control to work less||
1372|113|I|well. This effect can result in pregnancy. Examples include||
1372|114|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
1372|115|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
1372|116|I|as barbiturates, carbamazepine, felbamate, phenytoin, primidone,||
1372|117|I|topiramate), HIV drugs (such as nelfinavir, nevirapine), among||
1372|118|I|others.||
1372|119|B|||
1372|120|O|OVERDOSE:  Overdose with this medication is very unlikely.||
1372|121|O|However, if someone has overdosed and has serious symptoms such||
1372|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1372|123|O|poison control center right away. US residents can call||
1372|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1372|125|B|||
1372|126|N|NOTES:  Do not share this medication with others.||
1372|127|B|||
1372|128|D|MISSED DOSE:  Not applicable.||
1372|129|B|||
1372|130|R|STORAGE:  Store at room temperature away from light and moisture.||
1372|131|R|Do not store in the bathroom. Keep all medications away from||
1372|132|R|children and pets.||
1372|133|R|   Do not flush medications down the toilet or pour them into a||
1372|134|R|drain unless instructed to do so. Properly discard this product||
1372|135|R|when it is expired or no longer needed. Consult your pharmacist||
1372|136|R|or local waste disposal company.||
1372|137|B|||
1372|138|A|Information last revised May 2024.||
1372|139|A|Copyright(c) 2025 First Databank, Inc.||
1372|140|B|||
1373|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1373|002|Z|does NOT have all possible information about this product. This||
1373|003|Z|information does not assure that this product is safe, effective,||
1373|004|Z|or appropriate for you. This information is not individual||
1373|005|Z|medical advice and does not substitute for the advice of your||
1373|006|Z|health care professional. Always ask your health care||
1373|007|Z|professional for complete information about this product and your||
1373|008|Z|specific health needs.||
1373|009|B|||
1373|010|T|SIPULEUCEL-T - INJECTION||
1373|011|F|(SI-pu-LOO-sel-tee)||
1373|012|B|||
1373|013|C|COMMON BRAND NAME(S): Provenge||
1373|014|B|||
1373|015|U|USES:  This medication is used to treat advanced prostate cancer.||
1373|016|U|Sipuleucel-T is a type of vaccine created from your own immune||
1373|017|U|system cells that works by causing your immune system to attack||
1373|018|U|prostate cancer cells. This requires that you have a procedure to||
1373|019|U|remove some of your white blood cells, which are used to prepare||
1373|020|U|sipuleucel-T. Talk to your doctor about the risks and benefits of||
1373|021|U|this treatment.||
1373|022|B|||
1373|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1373|024|H|from your pharmacist before you start using sipuleucel-T and each||
1373|025|H|time you get a refill. If you have any questions, ask your doctor||
1373|026|H|or pharmacist.||
1373|027|H|   This medication is created specifically for you from your own||
1373|028|H|blood and should not be given to another patient. Three days||
1373|029|H|before your dose you will have a procedure in which your own||
1373|030|H|white blood cells are removed and then used to create||
1373|031|H|sipuleucel-T.||
1373|032|H|   Sipuleucel-T is given as a slow infusion into a vein by a||
1373|033|H|health care professional. It is given as directed by your doctor,||
1373|034|H|usually about every 2 weeks for a total of 3 doses.||
1373|035|H|   Infusion reactions may happen during or after the infusion of||
1373|036|H|this drug. Your doctor may prescribe other medications (such as||
1373|037|H|acetaminophen, antihistamines) to help prevent these side||
1373|038|H|effects. Tell your doctor right away if you have any symptoms of||
1373|039|H|infusion reaction such as chills, tiredness, fever, nausea,||
1373|040|H|vomiting, shortness of breath, fast/irregular heartbeat, or joint||
1373|041|H|pain. Your doctor may give you other medications to help with||
1373|042|H|these side effects or may slow down or stop your treatment for||
1373|043|H|some time.||
1373|044|H|   To get the most benefit from this medication, do not miss any||
1373|045|H|doses. To help you remember, mark your calendar with a reminder.||
1373|046|B|||
1373|047|S|SIDE EFFECTS:  See also How to Use section.||
1373|048|S|   Headache, sweating, muscle aches, or back pain may occur. If||
1373|049|S|any of these effects last or get worse, tell your doctor or||
1373|050|S|pharmacist promptly.||
1373|051|S|   Remember that this medication has been prescribed because your||
1373|052|S|doctor has judged that the benefit to you is greater than the||
1373|053|S|risk of side effects. Many people using this medication do not||
1373|054|S|have serious side effects.||
1373|055|S|   Tell your doctor right away if you have any serious side||
1373|056|S|effects, including: weakness on one side of the body, confusion,||
1373|057|S|trouble speaking.||
1373|058|S|   A very serious allergic reaction to this drug is rare.||
1373|059|S|However, get medical help right away if you notice any symptoms||
1373|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1373|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1373|062|S|breathing.||
1373|063|S|   This is not a complete list of possible side effects. If you||
1373|064|S|notice other effects not listed above, contact your doctor or||
1373|065|S|pharmacist.||
1373|066|S|   In the US -||
1373|067|S|   Call your doctor for medical advice about side effects. You||
1373|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1373|069|S|www.fda.gov/medwatch.||
1373|070|S|   In Canada - Call your doctor for medical advice about side||
1373|071|S|effects. You may report side effects to Health Canada at||
1373|072|S|1-866-234-2345.||
1373|073|B|||
1373|074|P|PRECAUTIONS:  Before receiving sipuleucel-T, tell your doctor or||
1373|075|P|pharmacist if you have any allergies. This product may contain||
1373|076|P|inactive ingredients, which can cause allergic reactions or other||
1373|077|P|problems. Talk to your pharmacist for more details.||
1373|078|P|   Before using this medication, tell your doctor or pharmacist||
1373|079|P|your medical history, especially of: heart problems, lung||
1373|080|P|problems, stroke.||
1373|081|P|   Before having surgery, tell your doctor or dentist about all||
1373|082|P|the products you use (including prescription drugs,||
1373|083|P|nonprescription drugs, and herbal products).||
1373|084|P|   This medication is not usually used by women. It is unlikely||
1373|085|P|to be used during pregnancy or breastfeeding. Consult your doctor||
1373|086|P|if you have any questions about this medication.||
1373|087|B|||
1373|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1373|089|I|medications work or increase your risk for serious side effects.||
1373|090|I|This document does not contain all possible drug interactions.||
1373|091|I|Keep a list of all the products you use (including||
1373|092|I|prescription/nonprescription drugs and herbal products) and share||
1373|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
1373|094|I|the dosage of any medicines without your doctor's approval.||
1373|095|B|||
1373|096|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1373|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1373|098|O|poison control center right away. US residents can call||
1373|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1373|100|B|||
1373|101|N|NOTES:  Do not share this medication with others.||
1373|102|N|   It is very important to be on time to each of your||
1373|103|N|appointments. This product has a short expiration period and must||
1373|104|N|be used before it expires, or additional procedures will be||
1373|105|N|needed to collect your white blood cells to prepare more||
1373|106|N|sipuleucel-T.||
1373|107|B|||
1373|108|D|MISSED DOSE:  It is important to get each dose of this medication||
1373|109|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1373|110|D|right away for a new dosing schedule.||
1373|111|B|||
1373|112|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
1373|113|R|medications away from children and pets.||
1373|114|R|   Do not flush medications down the toilet or pour them into a||
1373|115|R|drain unless instructed to do so. Properly discard this product||
1373|116|R|when it is expired or no longer needed. Consult your pharmacist||
1373|117|R|or local waste disposal company.||
1373|118|B|||
1373|119|A|Information last revised October 2024.||
1373|120|A|Copyright(c) 2025 First Databank, Inc.||
1373|121|B|||
1374|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1374|002|Z|does NOT have all possible information about this product. This||
1374|003|Z|information does not assure that this product is safe, effective,||
1374|004|Z|or appropriate for you. This information is not individual||
1374|005|Z|medical advice and does not substitute for the advice of your||
1374|006|Z|health care professional. Always ask your health care||
1374|007|Z|professional for complete information about this product and your||
1374|008|Z|specific health needs.||
1374|009|B|||
1374|010|T|PEGLOTICASE - INJECTION||
1374|011|F|(peg-LOE-ti-kase)||
1374|012|B|||
1374|013|C|COMMON BRAND NAME(S): Krystexxa||
1374|014|B|||
1374|015|W|WARNING:  Pegloticase may rarely cause a serious allergic||
1374|016|W|reaction. This may occur during or after the infusion of the||
1374|017|W|medication. Your doctor will check your blood before each||
1374|018|W|treatment and monitor you closely during and after infusion. Your||
1374|019|W|doctor should prescribe other medications (such as||
1374|020|W|antihistamines, corticosteroids) to help prevent an allergic||
1374|021|W|reaction. However, serious allergic reactions may still occur in||
1374|022|W|a few patients. Get medical help right away if you develop any||
1374|023|W|signs of an allergic reaction, such as rash, itching/swelling||
1374|024|W|(especially of the face/tongue/throat), severe dizziness, trouble||
1374|025|W|breathing, chest discomfort/pain.||
1374|026|W|   Do not use this medication if you have a certain metabolic||
1374|027|W|disorder called glucose-6-phosphate dehydrogenase (G6PD)||
1374|028|W|deficiency because it can severely damage your red blood cells||
1374|029|W|leading to anemia (hemolysis). If you are of African,||
1374|030|W|Mediterranean, or Southern Asian descent, you may be at higher||
1374|031|W|risk for G6PD deficiency and should be tested to see if you have||
1374|032|W|this condition before starting this medication.||
1374|033|B|||
1374|034|U|USES:  Pegloticase is used to treat gout which has not responded||
1374|035|U|to the usual treatments. It works by lowering high levels of uric||
1374|036|U|acid in your body. Increased uric acid in your body can cause||
1374|037|U|gout.||
1374|038|B|||
1374|039|H|HOW TO USE:  Read the Medication Guide provided by your||
1374|040|H|pharmacist before you start using pegloticase and each time you||
1374|041|H|get a refill. If you have any questions, ask your doctor or||
1374|042|H|pharmacist.||
1374|043|H|   If you are taking other medications (such as allopurinol,||
1374|044|H|febuxostat) by mouth to lower the level of uric acid in your||
1374|045|H|body, your doctor will direct you to stop the medication before||
1374|046|H|starting and during treatment with pegloticase. Taking these||
1374|047|H|drugs with pegloticase may lessen how well it works.||
1374|048|H|   This medication is given by injection into a vein (over at||
1374|049|H|least 2 hours) by a healthcare professional. It is usually given||
1374|050|H|every 2 weeks.||
1374|051|H|   Use this medication regularly to get the most benefit from it.||
1374|052|H|To help you remember, mark your calendar with a reminder.||
1374|053|H|   You may experience more gout attacks for several months after||
1374|054|H|starting this medicine while your body removes extra uric acid.||
1374|055|H|Your doctor may prescribe additional medication (such as||
1374|056|H|colchicine, nonsteroidal anti-inflammatory drugs-NSAIDs) to help||
1374|057|H|prevent and treat these gout attacks.||
1374|058|H|   Tell your doctor if your condition lasts or gets worse.||
1374|059|B|||
1374|060|S|SIDE EFFECTS:  See also Warning section.||
1374|061|S|   Nausea, vomiting, sore throat, or runny nose may occur. If any||
1374|062|S|of these effects last or get worse, tell your doctor or||
1374|063|S|pharmacist promptly.||
1374|064|S|   Remember that this medication has been prescribed because your||
1374|065|S|doctor has judged that the benefit to you is greater than the||
1374|066|S|risk of side effects. Many people using this medication do not||
1374|067|S|have serious side effects.||
1374|068|S|   This is not a complete list of possible side effects. If you||
1374|069|S|notice other effects not listed above, contact your doctor or||
1374|070|S|pharmacist.||
1374|071|S|   In the US -||
1374|072|S|   Call your doctor for medical advice about side effects. You||
1374|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1374|074|S|www.fda.gov/medwatch.||
1374|075|S|   In Canada - Call your doctor for medical advice about side||
1374|076|S|effects. You may report side effects to Health Canada at||
1374|077|S|1-866-234-2345.||
1374|078|B|||
1374|079|P|PRECAUTIONS:  See also Warning section.||
1374|080|P|   Before receiving pegloticase, tell your doctor or pharmacist||
1374|081|P|if you are allergic to it; or if you have any other allergies.||
1374|082|P|This product may contain inactive ingredients, which can cause||
1374|083|P|allergic reactions or other problems. Talk to your pharmacist for||
1374|084|P|more details.||
1374|085|P|   Before using this medication, tell your doctor or pharmacist||
1374|086|P|your medical history, especially of: a certain metabolic disorder||
1374|087|P|(G6PD deficiency), favism, heart failure.||
1374|088|P|   Before having surgery, tell your doctor or dentist about all||
1374|089|P|the products you use (including prescription drugs,||
1374|090|P|nonprescription drugs, and herbal products).||
1374|091|P|   During pregnancy, this medication should be used only when||
1374|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
1374|093|P|   It is unknown if this medication passes into breast milk.||
1374|094|P|Consult your doctor before breastfeeding.||
1374|095|B|||
1374|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1374|097|I|medications work or increase your risk for serious side effects.||
1374|098|I|This document does not contain all possible drug interactions.||
1374|099|I|Keep a list of all the products you use (including||
1374|100|I|prescription/nonprescription drugs and herbal products) and share||
1374|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
1374|102|I|the dosage of any medicines without your doctor's approval.||
1374|103|I|   Do not take other medications (such as allopurinol,||
1374|104|I|febuxostat) taken by mouth to lower the level of uric acid in||
1374|105|I|your body before and during treatment with pegloticase. (See also||
1374|106|I|How to Use section.)||
1374|107|B|||
1374|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1374|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1374|110|O|poison control center right away. US residents can call||
1374|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1374|112|B|||
1374|113|N|NOTES:  Lab and/or medical tests (such as uric acid levels)||
1374|114|N|should be done while you are using this medication. Keep all||
1374|115|N|medical and lab appointments. Consult your doctor for more||
1374|116|N|details.||
1374|117|B|||
1374|118|D|MISSED DOSE:  It is important to get each dose of this medication||
1374|119|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1374|120|D|right away for a new dosing schedule.||
1374|121|B|||
1374|122|R|STORAGE:  Not applicable. This medication is given in a hospital||
1374|123|R|or clinic and will not be stored at home.||
1374|124|B|||
1374|125|A|Information last revised October 2024.||
1374|126|A|Copyright(c) 2025 First Databank, Inc.||
1374|127|B|||
1376|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1376|002|Z|does NOT have all possible information about this product. This||
1376|003|Z|information does not assure that this product is safe, effective,||
1376|004|Z|or appropriate for you. This information is not individual||
1376|005|Z|medical advice and does not substitute for the advice of your||
1376|006|Z|health care professional. Always ask your health care||
1376|007|Z|professional for complete information about this product and your||
1376|008|Z|specific health needs.||
1376|009|B|||
1376|010|T|TESAMORELIN - INJECTION||
1376|011|F|(TES-a-moe-REL-in)||
1376|012|B|||
1376|013|C|COMMON BRAND NAME(S): Egrifta, Egrifta SV, Egrifta WR||
1376|014|B|||
1376|015|U|USES:  This medication is used to reduce excess fat in the||
1376|016|U|stomach area (abdomen) in people with HIV infection who have||
1376|017|U|changes in the way their body fat is distributed. Some HIV drugs||
1376|018|U|may cause this side effect (increased fat in the upper back and||
1376|019|U|stomach areas, decreased fat in the arms and legs). Tesamorelin||
1376|020|U|works by causing your body to make more growth hormone.||
1376|021|U|   This medication should not be used for weight loss.||
1376|022|B|||
1376|023|H|HOW TO USE:  Read the Patient Information Leaflet and||
1376|024|H|Instructions for Use if available from your pharmacist before you||
1376|025|H|start this medication and each time you get a refill. Ask your||
1376|026|H|health care professional how to prepare and use this medication.||
1376|027|H|If you have any questions, ask your doctor or pharmacist.||
1376|028|H|   Inject this medication under the skin as directed by your||
1376|029|H|doctor, usually once daily. The injection is given in the stomach||
1376|030|H|(abdomen).||
1376|031|H|   Before using, check this product for particles or||
1376|032|H|discoloration. If either is present, do not use the liquid.||
1376|033|H|Before injecting each dose, clean the skin you are going to||
1376|034|H|inject into (the injection site) with rubbing alcohol. Change the||
1376|035|H|injection site each time to lessen injury under the skin. Do not||
1376|036|H|inject into skin that is scarred, bruised, red, or irritated. To||
1376|037|H|lessen bruising, do not rub the injection site after a shot.||
1376|038|H|Learn how to store and discard medical supplies safely.||
1376|039|H|   There are different brands and strengths of this medication.||
1376|040|H|Do not switch to a different brand without your doctor's||
1376|041|H|approval.||
1376|042|H|   Use this medication regularly to get the most benefit from it.||
1376|043|H|To help you remember, use it at the same time each day.||
1376|044|B|||
1376|045|S|SIDE EFFECTS:  Redness, itching, pain, irritation, or bruising at||
1376|046|S|the injection site may occur. Muscle aches may also occur. If any||
1376|047|S|of these effects last or get worse, tell your doctor or||
1376|048|S|pharmacist promptly.||
1376|049|S|   Remember that this medication has been prescribed because your||
1376|050|S|doctor has judged that the benefit to you is greater than the||
1376|051|S|risk of side effects. Many people using this medication do not||
1376|052|S|have serious side effects.||
1376|053|S|   Tell your doctor right away if you have any serious side||
1376|054|S|effects, including: muscle/joint pain or stiffness,||
1376|055|S|numbness/tingling/swelling in your arms or legs.||
1376|056|S|   This medication may rarely make your blood sugar rise, which||
1376|057|S|can cause or worsen diabetes. Tell your doctor right away if you||
1376|058|S|have symptoms of high blood sugar such as increased||
1376|059|S|thirst/urination. If you already have diabetes, check your blood||
1376|060|S|sugar regularly as directed and share the results with your||
1376|061|S|doctor. Your doctor may need to adjust your diabetes medication,||
1376|062|S|exercise program, or diet.||
1376|063|S|   This medication may rarely increase the risk of getting a new||
1376|064|S|cancer or of a previous cancer coming back. Talk with your doctor||
1376|065|S|for details.||
1376|066|S|   A very serious allergic reaction to this drug is rare.||
1376|067|S|However, get medical help right away if you notice any symptoms||
1376|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1376|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1376|070|S|breathing.||
1376|071|S|   This is not a complete list of possible side effects. If you||
1376|072|S|notice other effects not listed above, contact your doctor or||
1376|073|S|pharmacist.||
1376|074|S|   In the US -||
1376|075|S|   Call your doctor for medical advice about side effects. You||
1376|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1376|077|S|www.fda.gov/medwatch.||
1376|078|S|   In Canada - Call your doctor for medical advice about side||
1376|079|S|effects. You may report side effects to Health Canada at||
1376|080|S|1-866-234-2345.||
1376|081|B|||
1376|082|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1376|083|P|pharmacist if you are allergic to it; or if you have any other||
1376|084|P|allergies. This product may contain inactive ingredients (such as||
1376|085|P|benzyl alcohol found in some brands), which can cause allergic||
1376|086|P|reactions or other problems. Talk to your pharmacist for more||
1376|087|P|details.||
1376|088|P|   Before using this medication, tell your doctor or pharmacist||
1376|089|P|your medical history, especially of: cancer, diabetes, tumors,||
1376|090|P|hypothalamus or pituitary gland problems (such as due to head||
1376|091|P|injury, pituitary tumor/surgery).||
1376|092|P|   Before having surgery, tell your doctor or dentist about all||
1376|093|P|the products you use (including prescription drugs,||
1376|094|P|nonprescription drugs, and herbal products).||
1376|095|P|   This medication must not be used during pregnancy. It may harm||
1376|096|P|an unborn baby. If you become pregnant or think you may be||
1376|097|P|pregnant, tell your doctor right away.||
1376|098|P|   It is unknown if this medication passes into breast milk.||
1376|099|P|Because breast milk may transmit HIV, consult your doctor before||
1376|100|P|breastfeeding.||
1376|101|B|||
1376|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1376|103|I|medications work or increase your risk for serious side effects.||
1376|104|I|This document does not contain all possible drug interactions.||
1376|105|I|Keep a list of all the products you use (including||
1376|106|I|prescription/nonprescription drugs and herbal products) and share||
1376|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1376|108|I|the dosage of any medicines without your doctor's approval.||
1376|109|B|||
1376|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1376|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1376|112|O|poison control center right away. US residents can call||
1376|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1376|114|B|||
1376|115|N|NOTES:  Do not share this medication with others.||
1376|116|N|   Lab and/or medical tests (such as blood sugar, IGF-1 levels)||
1376|117|N|should be done while you are using this medication. Keep all||
1376|118|N|medical and lab appointments. Consult your doctor for more||
1376|119|N|details.||
1376|120|B|||
1376|121|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1376|122|D|If it is near the time of the next dose, skip the missed dose.||
1376|123|D|Use your next dose at the regular time. Do not double the dose to||
1376|124|D|catch up.||
1376|125|B|||
1376|126|R|STORAGE:  Different brands of this medication have different||
1376|127|R|storage needs. Check the product package for instructions on how||
1376|128|R|to store your brand, or ask your pharmacist. Keep all medications||
1376|129|R|away from children and pets.||
1376|130|R|   Do not flush medications down the toilet or pour them into a||
1376|131|R|drain unless instructed to do so. Properly discard this product||
1376|132|R|when it is expired or no longer needed. Consult your pharmacist||
1376|133|R|or local waste disposal company.||
1376|134|B|||
1376|135|A|Information last revised July 2025.||
1376|136|A|Copyright(c) 2025 First Databank, Inc.||
1376|137|B|||
1377|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1377|002|Z|does NOT have all possible information about this product. This||
1377|003|Z|information does not assure that this product is safe, effective,||
1377|004|Z|or appropriate for you. This information is not individual||
1377|005|Z|medical advice and does not substitute for the advice of your||
1377|006|Z|health care professional. Always ask your health care||
1377|007|Z|professional for complete information about this product and your||
1377|008|Z|specific health needs.||
1377|009|B|||
1377|010|T|C1-ESTERASE INHIBITOR (TREATMENT) - INJECTION||
1377|011|B|||
1377|012|C|COMMON BRAND NAME(S): Berinert||
1377|013|B|||
1377|014|U|USES:  This medication is used to treat the swelling problems||
1377|015|U|that occur with a certain immune disease passed down through||
1377|016|U|families (hereditary angioedema-HAE). HAE is caused by low levels||
1377|017|U|or improper function of a natural substance produced by the body||
1377|018|U|(C1-inhibitor). Symptoms such as rapid swelling of the hands,||
1377|019|U|feet, limbs, face, tongue, or throat can occur. Swelling of the||
1377|020|U|intestinal tract may cause symptoms such as abdominal cramps,||
1377|021|U|diarrhea, or vomiting. Attacks of swelling may occur without||
1377|022|U|reason. However, anxiety, stress, sickness, and surgery may||
1377|023|U|trigger attacks in some people. This medication increases the||
1377|024|U|level of C1-inhibitor to help treat attacks of sudden swelling||
1377|025|U|due to hereditary angioedema.||
1377|026|B|||
1377|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1377|028|H|from your pharmacist before you start using C1-esterase inhibitor||
1377|029|H|and each time you get a refill. If you have any questions, ask||
1377|030|H|your doctor or pharmacist.||
1377|031|H|   This medication is given by injection into a vein, at the||
1377|032|H|first signs of an HAE attack, as directed by your doctor. The||
1377|033|H|dosage is based on weight and your medical condition.||
1377|034|H|   If you are using this medication at home, learn all||
1377|035|H|preparation and usage instructions from your health care||
1377|036|H|professional. Before using, check this product for particles or||
1377|037|H|discoloration. If either is present, do not use the liquid. Learn||
1377|038|H|how to store and discard medical supplies safely.||
1377|039|H|   After giving yourself a dose of this medication, you should||
1377|040|H|get medical help right away for follow-up treatment.||
1377|041|H|   Tell your doctor if your condition does not get better or if||
1377|042|H|it gets worse.||
1377|043|B|||
1377|044|S|SIDE EFFECTS:  A bad taste in the mouth may occur. Other side||
1377|045|S|effects are uncommon. If you notice any unusual side effects,||
1377|046|S|tell your doctor or pharmacist promptly.||
1377|047|S|   Remember that this medication has been prescribed because your||
1377|048|S|doctor has judged that the benefit to you is greater than the||
1377|049|S|risk of side effects. Many people using this medication do not||
1377|050|S|have serious side effects.||
1377|051|S|   This medication may increase the risk for blood clots,||
1377|052|S|especially when used at high doses. Get medical help right away||
1377|053|S|if any of these side effects occur: shortness of breath/rapid||
1377|054|S|breathing, chest/jaw/left arm pain, unusual sweating, confusion,||
1377|055|S|sudden dizziness/fainting, new pain/swelling/warmth in the||
1377|056|S|groin/calf, sudden/severe headaches, trouble speaking, weakness||
1377|057|S|on one side of the body, sudden vision changes.||
1377|058|S|   A very serious allergic reaction to this drug is rare.||
1377|059|S|However, get medical help right away if you notice any symptoms||
1377|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1377|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1377|062|S|breathing.||
1377|063|S|   This is not a complete list of possible side effects. If you||
1377|064|S|notice other effects not listed above, contact your doctor or||
1377|065|S|pharmacist.||
1377|066|S|   In the US -||
1377|067|S|   Call your doctor for medical advice about side effects. You||
1377|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1377|069|S|www.fda.gov/medwatch.||
1377|070|S|   In Canada - Call your doctor for medical advice about side||
1377|071|S|effects. You may report side effects to Health Canada at||
1377|072|S|1-866-234-2345.||
1377|073|B|||
1377|074|P|PRECAUTIONS:  Before using C1-esterase inhibitor, tell your||
1377|075|P|doctor or pharmacist if you are allergic to it; or if you have||
1377|076|P|any other allergies. This product may contain inactive||
1377|077|P|ingredients, which can cause allergic reactions or other||
1377|078|P|problems. Talk to your pharmacist for more details.||
1377|079|P|   Before using this medication, tell your doctor or pharmacist||
1377|080|P|your medical history, especially of: blood clots (such as in the||
1377|081|P|lungs, legs).||
1377|082|P|   This medication is made from human blood. Even though the||
1377|083|P|blood is carefully tested, and this medication goes through a||
1377|084|P|special manufacturing process, there is an extremely small chance||
1377|085|P|that you may get infections from the medication (for example,||
1377|086|P|virus infections such as hepatitis). Consult your doctor or||
1377|087|P|pharmacist for more information.||
1377|088|P|   Before traveling, talk to your doctor to make sure you have||
1377|089|P|enough of this medication.||
1377|090|P|   Before having surgery, tell your doctor or dentist about all||
1377|091|P|the products you use (including prescription drugs,||
1377|092|P|nonprescription drugs, and herbal products).||
1377|093|P|   During pregnancy, this medication should be used only when||
1377|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
1377|095|P|   It is unknown if this drug passes into breast milk. Consult||
1377|096|P|your doctor before breastfeeding.||
1377|097|B|||
1377|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1377|099|I|medications work or increase your risk for serious side effects.||
1377|100|I|This document does not contain all possible drug interactions.||
1377|101|I|Keep a list of all the products you use (including||
1377|102|I|prescription/nonprescription drugs and herbal products) and share||
1377|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
1377|104|I|the dosage of any medicines without your doctor's approval.||
1377|105|B|||
1377|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1377|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1377|108|O|poison control center right away. US residents can call||
1377|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1377|110|B|||
1377|111|N|NOTES:  Do not share this medication with others.||
1377|112|B|||
1377|113|D|MISSED DOSE:  Not applicable.||
1377|114|B|||
1377|115|R|STORAGE:  Store the unmixed vial in the refrigerator or at room||
1377|116|R|temperature away from light. Do not freeze. Keep the medication||
1377|117|R|in the original carton until ready to use. After mixing, use this||
1377|118|R|medication immediately or within the time period noted in the||
1377|119|R|product instructions. Discard any unused portion. Keep all||
1377|120|R|medications away from children and pets.||
1377|121|R|   Do not flush medications down the toilet or pour them into a||
1377|122|R|drain unless instructed to do so. Properly discard this product||
1377|123|R|when it is expired or no longer needed. Consult your pharmacist||
1377|124|R|or local waste disposal company.||
1377|125|B|||
1377|126|A|Information last revised November 2024.||
1377|127|A|Copyright(c) 2025 First Databank, Inc.||
1377|128|B|||
1378|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1378|002|Z|does NOT have all possible information about this product. This||
1378|003|Z|information does not assure that this product is safe, effective,||
1378|004|Z|or appropriate for you. This information is not individual||
1378|005|Z|medical advice and does not substitute for the advice of your||
1378|006|Z|health care professional. Always ask your health care||
1378|007|Z|professional for complete information about this product and your||
1378|008|Z|specific health needs.||
1378|009|B|||
1378|010|T|CLONIDINE 12-HOUR EXTENDED-RELEASE - ORAL||
1378|011|F|(KLON-i-deen)||
1378|012|B|||
1378|013|C|COMMON BRAND NAME(S): Kapvay||
1378|014|B|||
1378|015|U|USES:  This medication is used alone or with other medications to||
1378|016|U|treat attention deficit hyperactivity disorder (ADHD) as part of||
1378|017|U|a total treatment plan, including psychological, social, and||
1378|018|U|other treatments.||
1378|019|B|||
1378|020|V|OTHER USES:  This section contains uses of this drug that are not||
1378|021|V|listed in the approved professional labeling for the drug but||
1378|022|V|that may be prescribed by your health care professional. Use this||
1378|023|V|drug for a condition that is listed in this section only if it||
1378|024|V|has been so prescribed by your health care professional.||
1378|025|V|   This medication may also be used for high blood pressure||
1378|026|V|(hypertension) and to help people quit smoking.||
1378|027|B|||
1378|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1378|029|H|from your pharmacist before you start taking clonidine and each||
1378|030|H|time you get a refill. If you have any questions, ask your doctor||
1378|031|H|or pharmacist.||
1378|032|H|   Take this medication by mouth with or without food as directed||
1378|033|H|by your doctor, usually twice daily (in the morning and at||
1378|034|H|bedtime). If the doses are not equal, take the larger dose at||
1378|035|H|bedtime.||
1378|036|H|   To reduce your risk of side effects, your doctor may direct||
1378|037|H|you to start this medication at a low dose and gradually increase||
1378|038|H|your dose. Follow your doctor's instructions carefully.||
1378|039|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1378|040|H|Doing so can release all of the drug at once, increasing the risk||
1378|041|H|of side effects.||
1378|042|H|   The dosage is based on your medical condition and response to||
1378|043|H|treatment.||
1378|044|H|   Use this medication regularly to get the most benefit from it.||
1378|045|H|To help you remember, take it at the same times each day. Keep||
1378|046|H|taking this medication even if you feel well.||
1378|047|H|   Do not stop taking this medication without consulting your||
1378|048|H|doctor. You may experience symptoms such as headache, fast||
1378|049|H|heartbeat, nausea, anxiety, and flushing. A rapid rise in blood||
1378|050|H|pressure may also occur when the drug is suddenly stopped. The||
1378|051|H|risk is greater if you have used this drug for a long time or in||
1378|052|H|high doses, or if you are also taking a beta blocker (such as||
1378|053|H|atenolol). There have also been rare reports of severe, possibly||
1378|054|H|fatal reactions (such as stroke) from stopping this drug too||
1378|055|H|quickly. It is important that you do not run out of clonidine or||
1378|056|H|miss any doses. Tell your doctor or pharmacist right away if you||
1378|057|H|are unable to take the medication (for example, due to vomiting).||
1378|058|H|To prevent any reactions while you are stopping treatment with||
1378|059|H|this drug, your doctor may reduce your dose gradually. Consult||
1378|060|H|your doctor or pharmacist for more details. Report any new or||
1378|061|H|worsening symptoms right away.||
1378|062|H|   Other forms of this medication (such as immediate-release||
1378|063|H|tablets) may deliver different amounts of this medication. Do not||
1378|064|H|switch between the different forms of this medication without||
1378|065|H|your doctor's permission and directions. Also, do not take other||
1378|066|H|clonidine-containing products while taking this medication.||
1378|067|H|   Tell your doctor if your condition does not get better or if||
1378|068|H|it gets worse.||
1378|069|B|||
1378|070|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, tiredness,||
1378|071|S|stuffy nose, dry mouth, or constipation may occur. If any of||
1378|072|S|these effects last or get worse, tell your doctor or pharmacist||
1378|073|S|promptly.||
1378|074|S|   To reduce the risk of dizziness and lightheadedness, get up||
1378|075|S|slowly when rising from a sitting or lying position.||
1378|076|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
1378|077|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1378|078|S|substitute.||
1378|079|S|   Remember that this medication has been prescribed because your||
1378|080|S|doctor has judged that the benefit to you is greater than the||
1378|081|S|risk of side effects. Many people using this medication do not||
1378|082|S|have serious side effects.||
1378|083|S|   Tell your doctor right away if you have any serious side||
1378|084|S|effects, including: fainting, slow/irregular heartbeat,||
1378|085|S|mental/mood changes (such as irritability, depression).||
1378|086|S|   A very serious allergic reaction to this drug is rare.||
1378|087|S|However, get medical help right away if you notice any symptoms||
1378|088|S|of a serious allergic reaction, including: rash, itching/swelling||
1378|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1378|090|S|breathing.||
1378|091|S|   This is not a complete list of possible side effects. If you||
1378|092|S|notice other effects not listed above, contact your doctor or||
1378|093|S|pharmacist.||
1378|094|S|   In the US -||
1378|095|S|   Call your doctor for medical advice about side effects. You||
1378|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1378|097|S|www.fda.gov/medwatch.||
1378|098|S|   In Canada - Call your doctor for medical advice about side||
1378|099|S|effects. You may report side effects to Health Canada at||
1378|100|S|1-866-234-2345.||
1378|101|B|||
1378|102|P|PRECAUTIONS:  Before taking clonidine, tell your doctor or||
1378|103|P|pharmacist if you are allergic to it (including having a rash||
1378|104|P|while using clonidine patches); or if you have any other||
1378|105|P|allergies. This product may contain inactive ingredients, which||
1378|106|P|can cause allergic reactions or other problems. Talk to your||
1378|107|P|pharmacist for more details.||
1378|108|P|   Before using this medication, tell your doctor or pharmacist||
1378|109|P|your medical history, especially of: heart rhythm problems (such||
1378|110|P|as slow/irregular heartbeat), stroke, low blood pressure, kidney||
1378|111|P|disease.||
1378|112|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1378|113|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1378|114|P|machinery, or do anything that needs alertness until you can do||
1378|115|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1378|116|P|are using marijuana (cannabis).||
1378|117|P|   Before having surgery, tell your doctor or dentist about all||
1378|118|P|the products you use (including prescription drugs,||
1378|119|P|nonprescription drugs, and herbal products).||
1378|120|P|   Contact lens wearers may need to use wetting eye drops since||
1378|121|P|this medication can cause dry eyes.||
1378|122|P|   Older adults may be more sensitive to the side effects of this||
1378|123|P|product, especially dizziness, or drowsiness. These side effects||
1378|124|P|may increase the risk of falling.||
1378|125|P|   During pregnancy, this medication should be used only when||
1378|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
1378|127|P|   This drug passes into breast milk and may have undesirable||
1378|128|P|effects on a nursing infant. Consult your doctor before||
1378|129|P|breastfeeding.||
1378|130|B|||
1378|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1378|132|I|medications work or increase your risk for serious side effects.||
1378|133|I|This document does not contain all possible drug interactions.||
1378|134|I|Keep a list of all the products you use (including||
1378|135|I|prescription/nonprescription drugs and herbal products) and share||
1378|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
1378|137|I|the dosage of any medicines without your doctor's approval.||
1378|138|I|   Tell your doctor or pharmacist if you are taking other||
1378|139|I|products that cause drowsiness including alcohol, marijuana||
1378|140|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1378|141|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1378|142|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1378|143|I|codeine).||
1378|144|I|   Check the labels on all your medicines (such as allergy or||
1378|145|I|cough-and-cold products) because they may contain ingredients||
1378|146|I|that cause drowsiness. Ask your pharmacist about using those||
1378|147|I|products safely.||
1378|148|I|   Some products have ingredients that could raise your blood||
1378|149|I|pressure. Tell your pharmacist what products you are using, and||
1378|150|I|ask how to use them safely (especially cough-and-cold products,||
1378|151|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1378|152|B|||
1378|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1378|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1378|155|O|poison control center right away. US residents can call||
1378|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1378|157|O|Symptoms of overdose may include: severe dizziness/drowsiness,||
1378|158|O|fainting, slow/irregular heartbeat, slow/shallow breathing,||
1378|159|O|seizures.||
1378|160|B|||
1378|161|N|NOTES:  Do not share this medication with others.||
1378|162|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
1378|163|N|should be done while you are taking this medication. Keep all||
1378|164|N|medical and lab appointments. Consult your doctor for more||
1378|165|N|details.||
1378|166|B|||
1378|167|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1378|168|D|next dose at the regular time. Do not double the dose to catch||
1378|169|D|up. If you miss 2 or more doses in a row, contact your doctor||
1378|170|D|right away.||
1378|171|B|||
1378|172|R|STORAGE:  Store at room temperature away from light and moisture.||
1378|173|R|Do not store in the bathroom. Keep all medications away from||
1378|174|R|children and pets.||
1378|175|R|   Do not flush medications down the toilet or pour them into a||
1378|176|R|drain unless instructed to do so. Properly discard this product||
1378|177|R|when it is expired or no longer needed. Consult your pharmacist||
1378|178|R|or local waste disposal company.||
1378|179|B|||
1378|180|A|Information last revised October 2024.||
1378|181|A|Copyright(c) 2025 First Databank, Inc.||
1378|182|B|||
1379|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1379|002|Z|does NOT have all possible information about this product. This||
1379|003|Z|information does not assure that this product is safe, effective,||
1379|004|Z|or appropriate for you. This information is not individual||
1379|005|Z|medical advice and does not substitute for the advice of your||
1379|006|Z|health care professional. Always ask your health care||
1379|007|Z|professional for complete information about this product and your||
1379|008|Z|specific health needs.||
1379|009|B|||
1379|010|T|LURASIDONE - ORAL||
1379|011|F|(loo-RAS-i-done)||
1379|012|B|||
1379|013|C|COMMON BRAND NAME(S): Latuda||
1379|014|B|||
1379|015|W|WARNING:  There may be a slightly increased risk of serious,||
1379|016|W|possibly fatal side effects (such as stroke, heart failure,||
1379|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1379|018|W|by older adults with dementia. This medication is not approved||
1379|019|W|for the treatment of dementia-related behavior problems. Discuss||
1379|020|W|the risks and benefits of this medication, as well as other||
1379|021|W|effective and possibly safer treatments for dementia-related||
1379|022|W|behavior problems, with the doctor.||
1379|023|W|   Lurasidone is used to treat certain mental/mood disorders||
1379|024|W|(such as schizophrenia, depression associated with bipolar||
1379|025|W|disorder). Drugs used to treat depression can help prevent||
1379|026|W|suicidal thoughts/attempts and provide other important benefits.||
1379|027|W|However, studies have shown that a small number of people||
1379|028|W|(especially people younger than 25) who take drugs to treat||
1379|029|W|depression may experience worsening depression, other mental/mood||
1379|030|W|symptoms, or suicidal thoughts/attempts. It is very important to||
1379|031|W|talk with the doctor about the risks and benefits of drugs used||
1379|032|W|to treat depression (especially for people younger than 25), even||
1379|033|W|if treatment is not for a mental/mood condition.||
1379|034|W|   Tell the doctor right away if you notice worsening||
1379|035|W|depression/other psychiatric conditions, unusual behavior changes||
1379|036|W|(including possible suicidal thoughts/attempts), or other||
1379|037|W|mental/mood changes (including new/worsening anxiety, panic||
1379|038|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1379|039|W|impulsive actions, severe restlessness, very rapid speech). Be||
1379|040|W|especially watchful for these symptoms when a new drug to treat||
1379|041|W|depression is started or when the dose is changed.||
1379|042|B|||
1379|043|U|USES:  This medication is used to treat certain mental/mood||
1379|044|U|disorders (such as schizophrenia, depression associated with||
1379|045|U|bipolar disorder). Lurasidone belongs to a class of drugs known||
1379|046|U|as atypical antipsychotics. It works by helping to restore the||
1379|047|U|balance of certain natural substances in the brain.||
1379|048|B|||
1379|049|H|HOW TO USE:  Read the Medication Guide provided by your||
1379|050|H|pharmacist before you start taking lurasidone and each time you||
1379|051|H|get a refill. If you have any questions, ask your doctor or||
1379|052|H|pharmacist.||
1379|053|H|   Take this medication by mouth with food as directed by your||
1379|054|H|doctor, usually once daily. The dosage is based on your medical||
1379|055|H|condition, response to treatment, age, and other medications you||
1379|056|H|may be taking. Be sure to tell your doctor and pharmacist about||
1379|057|H|all the products you use (including prescription drugs,||
1379|058|H|nonprescription drugs, and herbal products).||
1379|059|H|   Take this medication regularly to get the most benefit from||
1379|060|H|it. To help you remember, take it at the same time each day.||
1379|061|H|   Keep taking this medication exactly as prescribed, even if you||
1379|062|H|are feeling better and thinking more clearly. Do not increase||
1379|063|H|your dose or take this drug more often than prescribed. Your||
1379|064|H|symptoms will not improve any faster, and your risk of side||
1379|065|H|effects will increase. Do not stop taking this medication without||
1379|066|H|consulting your doctor.||
1379|067|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1379|068|H|using this medication unless your doctor or pharmacist says you||
1379|069|H|may do so safely. Grapefruit can increase the chance of side||
1379|070|H|effects with this medicine. Ask your doctor or pharmacist for||
1379|071|H|more details.||
1379|072|H|   Tell your doctor if your condition does not get better or if||
1379|073|H|it gets worse. It may take several weeks before you feel the full||
1379|074|H|benefit of this medication.||
1379|075|B|||
1379|076|S|SIDE EFFECTS:  See also Warning section.||
1379|077|S|   Drowsiness, dizziness, lightheadedness, nausea, shaking,||
1379|078|S|weight gain, mask-like facial expression, inability to keep||
1379|079|S|still, and agitation may occur. If any of these effects last or||
1379|080|S|get worse, tell your doctor or pharmacist promptly. Your doctor||
1379|081|S|may order another medication to lessen these effects.||
1379|082|S|   This medication may cause a serious drop in blood pressure,||
1379|083|S|especially when starting this medication. Dizziness and||
1379|084|S|lightheadedness can increase the risk of falling. Get up slowly||
1379|085|S|when rising from a sitting or lying position.||
1379|086|S|   Remember that this medication has been prescribed because your||
1379|087|S|doctor has judged that the benefit to you is greater than the||
1379|088|S|risk of side effects. Many people using this medication do not||
1379|089|S|have serious side effects.||
1379|090|S|   Tell your doctor right away if you have any serious side||
1379|091|S|effects, including: drooling/trouble swallowing, fainting,||
1379|092|S|interrupted breathing during sleep.||
1379|093|S|   Rarely, this medication may cause face/muscle twitching and||
1379|094|S|uncontrollable movements (tardive dyskinesia). In some cases,||
1379|095|S|this condition may be permanent. Tell your doctor right away if||
1379|096|S|you develop any uncontrollable movements such as lip smacking,||
1379|097|S|mouth puckering, tongue thrusting, chewing, or unusual arm/leg||
1379|098|S|movements.||
1379|099|S|   This drug may rarely make your blood sugar rise, which can||
1379|100|S|cause or worsen diabetes. Weight gain from this drug may increase||
1379|101|S|the risk of this side effect. Tell your doctor right away if you||
1379|102|S|have symptoms of high blood sugar such as increased||
1379|103|S|thirst/urination. If you already have diabetes, check your blood||
1379|104|S|sugar regularly as directed and share the results with your||
1379|105|S|doctor. Your doctor may need to adjust your diabetes medication,||
1379|106|S|exercise program, or diet.||
1379|107|S|   This medication may also cause a rise in your blood fat levels||
1379|108|S|(cholesterol and triglycerides). These increases, along with||
1379|109|S|diabetes and weight gain, may increase your risk for developing||
1379|110|S|heart disease. Discuss the risks and benefits of treatment with||
1379|111|S|your doctor.||
1379|112|S|   In rare cases, lurasidone may increase your level of a certain||
1379|113|S|substance made by the body (prolactin). For females, this||
1379|114|S|increase in prolactin may result in unwanted breast milk,||
1379|115|S|missed/stopped periods, or difficulty becoming pregnant. For||
1379|116|S|males, it may result in decreased sexual ability, inability to||
1379|117|S|produce sperm, or enlarged breasts. If you develop any of these||
1379|118|S|symptoms, tell your doctor right away.||
1379|119|S|   Rarely, males may have a painful or prolonged erection lasting||
1379|120|S|4 or more hours. If this occurs, stop using this drug and get||
1379|121|S|medical help right away, or permanent problems could occur.||
1379|122|S|   Get medical help right away if you have any very serious side||
1379|123|S|effects, including: seizure.||
1379|124|S|   This medication may rarely cause a very serious condition||
1379|125|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1379|126|S|right away if you have any of the following symptoms: fever,||
1379|127|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1379|128|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1379|129|S|signs of kidney problems (such as change in the amount of urine).||
1379|130|S|   A very serious allergic reaction to this drug is rare.||
1379|131|S|However, get medical help right away if you notice any symptoms||
1379|132|S|of a serious allergic reaction, including: fever, swollen lymph||
1379|133|S|nodes, rash, itching/swelling (especially of the||
1379|134|S|face/tongue/throat), severe dizziness, trouble breathing.||
1379|135|S|   This is not a complete list of possible side effects. If you||
1379|136|S|notice other effects not listed above, contact your doctor or||
1379|137|S|pharmacist.||
1379|138|S|   In the US -||
1379|139|S|   Call your doctor for medical advice about side effects. You||
1379|140|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1379|141|S|www.fda.gov/medwatch.||
1379|142|S|   In Canada - Call your doctor for medical advice about side||
1379|143|S|effects. You may report side effects to Health Canada at||
1379|144|S|1-866-234-2345.||
1379|145|B|||
1379|146|P|PRECAUTIONS:  See also Warning section.||
1379|147|P|   Before taking lurasidone, tell your doctor or pharmacist if||
1379|148|P|you are allergic to it; or if you have any other allergies. This||
1379|149|P|product may contain inactive ingredients, which can cause||
1379|150|P|allergic reactions or other problems. Talk to your pharmacist for||
1379|151|P|more details.||
1379|152|P|   Before using this medication, tell your doctor or pharmacist||
1379|153|P|your medical history, especially of: kidney problems, liver||
1379|154|P|problems, stroke, breast cancer, diabetes (including family||
1379|155|P|history), obesity, low blood pressure, seizures, low white blood||
1379|156|P|cell count, dementia (such as Alzheimer's Disease), trouble||
1379|157|P|swallowing, breathing trouble during sleep (sleep apnea).||
1379|158|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1379|159|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1379|160|P|machinery, or do anything that needs alertness until you can do||
1379|161|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1379|162|P|are using marijuana (cannabis).||
1379|163|P|   Before having surgery, tell your doctor or dentist about all||
1379|164|P|the products you use (including prescription drugs,||
1379|165|P|nonprescription drugs, and herbal products).||
1379|166|P|   This medication may make you sweat less, making you more||
1379|167|P|likely to get heat stroke. Avoid doing things that may cause you||
1379|168|P|to overheat, such as hard work or exercise in hot weather, or||
1379|169|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1379|170|P|and dress lightly. If you overheat, quickly look for a place to||
1379|171|P|cool down and rest. Get medical help right away if you have a||
1379|172|P|fever that does not go away, mental/mood changes, headache, or||
1379|173|P|dizziness.||
1379|174|P|   Older adults may be more sensitive to the side effects of this||
1379|175|P|drug, especially drowsiness, dizziness, and lightheadedness.||
1379|176|P|Drowsiness, dizziness, and lightheadedness can increase the risk||
1379|177|P|of falling.||
1379|178|P|   During pregnancy, this medication should be used only when||
1379|179|P|clearly needed. Babies born to mothers who have used this drug||
1379|180|P|during the last 3 months of pregnancy may rarely develop symptoms||
1379|181|P|including muscle stiffness or shakiness, drowsiness,||
1379|182|P|feeding/breathing difficulties, or constant crying. If you notice||
1379|183|P|any of these symptoms in your newborn especially during their||
1379|184|P|first month, tell the doctor right away.||
1379|185|P|   Since untreated mental/mood problems (such as schizophrenia,||
1379|186|P|bipolar disorder, depression) can be a serious condition, do not||
1379|187|P|stop taking this medication unless directed by your doctor. If||
1379|188|P|you are planning pregnancy, become pregnant, or think you may be||
1379|189|P|pregnant, immediately discuss with your doctor the benefits and||
1379|190|P|risks of using this medication during pregnancy.||
1379|191|P|   It is unknown if this medication passes into breast milk.||
1379|192|P|Consult your doctor before breastfeeding.||
1379|193|B|||
1379|194|I|DRUG INTERACTIONS:  See also How To Use section.||
1379|195|I|   Drug interactions may change how your medications work or||
1379|196|I|increase your risk for serious side effects. This document does||
1379|197|I|not contain all possible drug interactions. Keep a list of all||
1379|198|I|the products you use (including prescription/nonprescription||
1379|199|I|drugs and herbal products) and share it with your doctor and||
1379|200|I|pharmacist. Do not start, stop, or change the dosage of any||
1379|201|I|medicines without your doctor's approval.||
1379|202|I|   Other medications can affect the removal of lurasidone from||
1379|203|I|your body, which may affect how lurasidone works. Examples||
1379|204|I|include cobicistat, diltiazem, ritonavir, telithromycin, azole||
1379|205|I|antifungals (such as ketoconazole, itraconazole), certain HIV||
1379|206|I|protease inhibitors (such as nelfinavir), macrolide antibiotics||
1379|207|I|(such as clarithromycin), rifamycins (such as rifampin,||
1379|208|I|rifabutin), antidepressants (such as fluoxetine, paroxetine,||
1379|209|I|nefazodone), among others.||
1379|210|I|   Tell your doctor or pharmacist if you are taking other||
1379|211|I|products that cause drowsiness such as opioid pain or cough||
1379|212|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1379|213|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1379|214|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1379|215|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1379|216|I|diphenhydramine).||
1379|217|I|   Check the labels on all your medicines (such as allergy or||
1379|218|I|cough-and-cold products) because they may contain ingredients||
1379|219|I|that cause dizziness or drowsiness. Ask your pharmacist about||
1379|220|I|using those products safely.||
1379|221|B|||
1379|222|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1379|223|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1379|224|O|poison control center right away. US residents can call||
1379|225|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1379|226|B|||
1379|227|N|NOTES:  Do not share this medication with others.||
1379|228|N|   Lab and/or medical tests (such as blood sugar, complete blood||
1379|229|N|count, blood pressure, weight, cholesterol/triglyceride levels)||
1379|230|N|may be done while you are taking this medication. Keep all||
1379|231|N|medical and lab appointments. Consult your doctor for more||
1379|232|N|details.||
1379|233|B|||
1379|234|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1379|235|D|remember. If it is near the time of the next dose, skip the||
1379|236|D|missed dose. Take your next dose at the regular time. Do not||
1379|237|D|double the dose to catch up.||
1379|238|B|||
1379|239|R|STORAGE:  Store at room temperature away from light and moisture.||
1379|240|R|Do not store in the bathroom. Keep all medications away from||
1379|241|R|children and pets.||
1379|242|R|   Do not flush medications down the toilet or pour them into a||
1379|243|R|drain unless instructed to do so. Properly discard this product||
1379|244|R|when it is expired or no longer needed. Consult your pharmacist||
1379|245|R|or local waste disposal company.||
1379|246|B|||
1379|247|A|Information last revised November 2024.||
1379|248|A|Copyright(c) 2025 First Databank, Inc.||
1379|249|B|||
1380|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1380|002|Z|does NOT have all possible information about this product. This||
1380|003|Z|information does not assure that this product is safe, effective,||
1380|004|Z|or appropriate for you. This information is not individual||
1380|005|Z|medical advice and does not substitute for the advice of your||
1380|006|Z|health care professional. Always ask your health care||
1380|007|Z|professional for complete information about this product and your||
1380|008|Z|specific health needs.||
1380|009|B|||
1380|010|T|DEXTROMETHORPHAN/QUINIDINE - ORAL||
1380|011|F|(DEX-troe-meth-OR-fan/KWIN-i-deen)||
1380|012|B|||
1380|013|C|COMMON BRAND NAME(S): Nuedexta||
1380|014|B|||
1380|015|U|USES:  This medication is used to treat a certain mental/mood||
1380|016|U|disorder (pseudobulbar affect). This disorder may occur due to||
1380|017|U|various conditions that affect the brain (such as stroke,||
1380|018|U|amyotrophic lateral sclerosis-ALS, multiple sclerosis). This||
1380|019|U|medication may help decrease sudden outbursts of||
1380|020|U|uncontrollable/inappropriate laughing and/or crying.||
1380|021|U|   This medication is a combination of 2 ingredients:||
1380|022|U|dextromethorphan and quinidine. Dextromethorphan works in the||
1380|023|U|brain, though it is not known exactly how it helps treat||
1380|024|U|pseudobulbar affect. Quinidine is added to this medication to||
1380|025|U|increase the effect of dextromethorphan.||
1380|026|B|||
1380|027|H|HOW TO USE:  Take this medication by mouth with or without food||
1380|028|H|with a full glass of water (8 ounces/240 milliliters) as directed||
1380|029|H|by your doctor, usually one capsule every 12 hours. Do not lie||
1380|030|H|down for at least 10 minutes after taking this medication. To||
1380|031|H|reduce your risk of side effects, your doctor may direct you to||
1380|032|H|start this medication at a low dose (usually one capsule daily||
1380|033|H|for 7 days) and gradually increase your dose. Follow your||
1380|034|H|doctor's instructions carefully.||
1380|035|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1380|036|H|using this medication unless your doctor or pharmacist says you||
1380|037|H|may do so safely. Grapefruit can increase the chance of side||
1380|038|H|effects with this medicine. Ask your doctor or pharmacist for||
1380|039|H|more details.||
1380|040|H|   Use this medication regularly to get the most benefit from it.||
1380|041|H|To help you remember, take it at the same time(s) each day.||
1380|042|H|   Tell your doctor if your condition does not get better or if||
1380|043|H|it gets worse.||
1380|044|B|||
1380|045|S|SIDE EFFECTS:  Diarrhea, dizziness, cough, vomiting, weakness, or||
1380|046|S|swelling in the hands/ankles/feet may occur. Rarely, slight||
1380|047|S|drowsiness may also occur. If any of these effects last or get||
1380|048|S|worse, tell your doctor or pharmacist promptly.||
1380|049|S|   Remember that this medication has been prescribed because your||
1380|050|S|doctor has judged that the benefit to you is greater than the||
1380|051|S|risk of side effects. Many people using this medication do not||
1380|052|S|have serious side effects.||
1380|053|S|   Tell your doctor right away if you have any serious side||
1380|054|S|effects, including: easy bruising/bleeding, dark urine, muscle||
1380|055|S|spasms, signs of infection (such as sore throat that doesn't go||
1380|056|S|away, fever, chills), stomach/abdominal pain, yellowing||
1380|057|S|eyes/skin, lupus-like symptoms (joint/muscle pain, chest pain).||
1380|058|S|   Get medical help right away if you have any very serious side||
1380|059|S|effects, including: fainting, fast/irregular heartbeat, severe||
1380|060|S|dizziness.||
1380|061|S|   This medication may increase serotonin and rarely cause a very||
1380|062|S|serious condition called serotonin syndrome/toxicity. The risk||
1380|063|S|increases if you are also taking other drugs that increase||
1380|064|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1380|065|S|take (see Drug Interactions section). Get medical help right away||
1380|066|S|if you develop some of the following symptoms: fast heartbeat,||
1380|067|S|hallucinations, loss of coordination, severe||
1380|068|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1380|069|S|unusual agitation/restlessness.||
1380|070|S|   A very serious allergic reaction to this drug is rare.||
1380|071|S|However, get medical help right away if you notice any symptoms||
1380|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1380|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1380|074|S|breathing.||
1380|075|S|   This is not a complete list of possible side effects. If you||
1380|076|S|notice other effects not listed above, contact your doctor or||
1380|077|S|pharmacist.||
1380|078|S|   In the US -||
1380|079|S|   Call your doctor for medical advice about side effects. You||
1380|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1380|081|S|www.fda.gov/medwatch.||
1380|082|S|   In Canada - Call your doctor for medical advice about side||
1380|083|S|effects. You may report side effects to Health Canada at||
1380|084|S|1-866-234-2345.||
1380|085|B|||
1380|086|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1380|087|P|pharmacist if you are allergic to dextromethorphan, quinidine,||
1380|088|P|quinine, or mefloquine; or if you have any other allergies. This||
1380|089|P|product may contain inactive ingredients, which can cause||
1380|090|P|allergic reactions or other problems. Talk to your pharmacist for||
1380|091|P|more details.||
1380|092|P|   Before using this medication, tell your doctor or pharmacist||
1380|093|P|your medical history, especially of: blood/bone marrow disorder||
1380|094|P|(such as low platelets/white blood cells/red blood cells), a||
1380|095|P|certain enzyme deficiency (G6PD deficiency), kidney disease,||
1380|096|P|liver disease, lupus-like syndrome, myasthenia gravis.||
1380|097|P|   Quinidine may cause a condition that affects the heart rhythm||
1380|098|P|(QT prolongation). QT prolongation can rarely cause serious||
1380|099|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1380|100|P|as severe dizziness, fainting) that need medical attention right||
1380|101|P|away.||
1380|102|P|   The risk of QT prolongation may be increased if you have||
1380|103|P|certain medical conditions or are taking other drugs that may||
1380|104|P|cause QT prolongation. Before using quinidine, tell your doctor||
1380|105|P|or pharmacist of all the drugs you take and if you have any of||
1380|106|P|the following conditions: certain heart problems (heart failure,||
1380|107|P|slow heartbeat, QT prolongation in the EKG), family history of||
1380|108|P|certain heart problems (QT prolongation in the EKG, sudden||
1380|109|P|cardiac death).||
1380|110|P|   Low levels of potassium or magnesium in the blood may also||
1380|111|P|increase your risk of QT prolongation. This risk may increase if||
1380|112|P|you use certain drugs (such as diuretics/"water pills") or if you||
1380|113|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1380|114|P|Talk to your doctor about using quinidine safely.||
1380|115|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1380|116|P|can make you more dizzy. Do not drive, use machinery, or do||
1380|117|P|anything that needs alertness until you can do it safely. Limit||
1380|118|P|alcoholic beverages. Talk to your doctor if you are using||
1380|119|P|marijuana (cannabis).||
1380|120|P|   Before having surgery, tell your doctor or dentist about all||
1380|121|P|the products you use (including prescription drugs,||
1380|122|P|nonprescription drugs, and herbal products).||
1380|123|P|   Older adults may be more sensitive to the side effects of this||
1380|124|P|drug, especially dizziness and QT prolongation (see above).||
1380|125|P|Dizziness can increase the risk of falling.||
1380|126|P|   During pregnancy, this medication should be used only when||
1380|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
1380|128|P|   This medication passes into breast milk. Consult your doctor||
1380|129|P|before breastfeeding.||
1380|130|B|||
1380|131|I|DRUG INTERACTIONS:  See also the How to Use section.||
1380|132|I|   Drug interactions may change how your medications work or||
1380|133|I|increase your risk for serious side effects. This document does||
1380|134|I|not contain all possible drug interactions. Keep a list of all||
1380|135|I|the products you use (including prescription/nonprescription||
1380|136|I|drugs and herbal products) and share it with your doctor and||
1380|137|I|pharmacist. Do not start, stop, or change the dosage of any||
1380|138|I|medicines without your doctor's approval.||
1380|139|I|   Some products that may interact with this drug include:||
1380|140|I|fingolimod, propafenone, rolapitant.||
1380|141|I|   This medication can slow down the removal of other medications||
1380|142|I|from your body, which may affect how they work. Examples of||
1380|143|I|affected drugs include aliskiren, codeine, digoxin, mefloquine,||
1380|144|I|tricyclic antidepressants (such as desipramine, imipramine),||
1380|145|I|among others.||
1380|146|I|   Other medications can affect the removal of quinidine from||
1380|147|I|your body, which may affect how quinidine works. Examples include||
1380|148|I|cobicistat, mifepristone, ritonavir, certain azole antifungals||
1380|149|I|(including fluconazole, itraconazole, ketoconazole, posaconazole,||
1380|150|I|voriconazole), certain protease inhibitors (such as nelfinavir,||
1380|151|I|tipranavir), among others.||
1380|152|I|   Taking MAO inhibitors with this medication may cause a serious||
1380|153|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1380|154|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1380|155|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1380|156|I|selegiline, tranylcypromine) during treatment with this||
1380|157|I|medication. Most MAO inhibitors should also not be taken for two||
1380|158|I|weeks before and after treatment with this medication. Ask your||
1380|159|I|doctor when to start or stop taking this medication.||
1380|160|I|   Many drugs besides quinidine may affect the heart rhythm (QT||
1380|161|I|prolongation), including artemether/lumefantrine, ranolazine,||
1380|162|I|toremifene, antiarrhythmic drugs (such as amiodarone,||
1380|163|I|disopyramide, dofetilide, dronedarone, ibutilide, sotalol),||
1380|164|I|antipsychotics (such as pimozide, thioridazine, ziprasidone),||
1380|165|I|among others.||
1380|166|I|   The risk of serotonin syndrome/toxicity increases if you are||
1380|167|I|also taking other drugs that increase serotonin. Examples include||
1380|168|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1380|169|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1380|170|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1380|171|I|serotonin syndrome/toxicity may be more likely when you start or||
1380|172|I|increase the dose of these drugs.||
1380|173|I|   Quinidine is very similar to quinine. Do not use medications||
1380|174|I|containing quinine while using quinidine.||
1380|175|B|||
1380|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1380|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1380|178|O|poison control center right away. US residents can call||
1380|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1380|180|O|Symptoms of overdose may include: severe dizziness, fainting,||
1380|181|O|fast/irregular heartbeat.||
1380|182|B|||
1380|183|N|NOTES:  Do not share this medication with others.||
1380|184|N|   Lab and/or medical tests (such as complete blood count, liver||
1380|185|N|function) may be done while you are taking this medication. Keep||
1380|186|N|all medical and lab appointments. Consult your doctor for more||
1380|187|N|details.||
1380|188|B|||
1380|189|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1380|190|D|remember. If it is near the time of the next dose, skip the||
1380|191|D|missed dose. Take your next dose at the regular time. Do not||
1380|192|D|double the dose to catch up.||
1380|193|B|||
1380|194|R|STORAGE:  Store at room temperature away from light and moisture.||
1380|195|R|Do not store in the bathroom. Keep all medications away from||
1380|196|R|children and pets.||
1380|197|R|   Do not flush medications down the toilet or pour them into a||
1380|198|R|drain unless instructed to do so. Properly discard this product||
1380|199|R|when it is expired or no longer needed. Consult your pharmacist||
1380|200|R|or local waste disposal company.||
1380|201|B|||
1380|202|A|Information last revised July 2025.||
1380|203|A|Copyright(c) 2025 First Databank, Inc.||
1380|204|B|||
1382|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1382|002|Z|does NOT have all possible information about this product. This||
1382|003|Z|information does not assure that this product is safe, effective,||
1382|004|Z|or appropriate for you. This information is not individual||
1382|005|Z|medical advice and does not substitute for the advice of your||
1382|006|Z|health care professional. Always ask your health care||
1382|007|Z|professional for complete information about this product and your||
1382|008|Z|specific health needs.||
1382|009|B|||
1382|010|T|CLONIDINE 24-HOUR EXTENDED-RELEASE - ORAL||
1382|011|F|(KLON-i-deen)||
1382|012|B|||
1382|013|C|COMMON BRAND NAME(S): Nexiclon XR||
1382|014|B|||
1382|015|U|USES:  This medication is used to treat high blood pressure.||
1382|016|U|Lowering high blood pressure helps prevent strokes, heart||
1382|017|U|attacks, and kidney problems. Clonidine belongs to a class of||
1382|018|U|drugs (central alpha agonists) that act in the brain to lower||
1382|019|U|blood pressure. It works by relaxing blood vessels so blood can||
1382|020|U|flow more easily.||
1382|021|B|||
1382|022|H|HOW TO USE:  Take this medication by mouth with or without food||
1382|023|H|as directed by your doctor, usually once daily at bedtime.||
1382|024|H|   Do not crush or chew extended-release tablets. Doing so can||
1382|025|H|release all of the drug at once, increasing the risk of side||
1382|026|H|effects. Also, do not split the tablets unless they have a score||
1382|027|H|line and your doctor or pharmacist tells you to do so. Swallow||
1382|028|H|the whole or split tablet without crushing or chewing.||
1382|029|H|   The dosage is based on your medical condition and response to||
1382|030|H|treatment.||
1382|031|H|   Use this medication regularly to get the most benefit from it.||
1382|032|H|To help you remember, take it at the same time each day. Keep||
1382|033|H|taking this medication even if you feel well. Most people with||
1382|034|H|high blood pressure do not feel sick.||
1382|035|H|   Do not stop taking this medication without consulting your||
1382|036|H|doctor. You may experience symptoms such as nervousness,||
1382|037|H|agitation, shaking, and headache. A rapid rise in blood pressure||
1382|038|H|may also occur when the drug is suddenly stopped. The risk is||
1382|039|H|greater if you have used this drug for a long time or in high||
1382|040|H|doses, or if you are also taking a beta blocker (such as||
1382|041|H|atenolol). There have also been rare reports of severe, possibly||
1382|042|H|fatal reactions (such as stroke) from stopping this drug too||
1382|043|H|quickly. Therefore, it is important that you do not run out of||
1382|044|H|clonidine or miss any doses. Tell your doctor or pharmacist||
1382|045|H|immediately if you are unable to take the medication (for||
1382|046|H|example, due to vomiting). To prevent any reactions while you are||
1382|047|H|stopping treatment with this drug, your doctor may reduce your||
1382|048|H|dose gradually. Consult your doctor or pharmacist for more||
1382|049|H|details. Report any new or worsening symptoms immediately.||
1382|050|H|   When this medication is used for a long time, it may not work||
1382|051|H|as well and may require different dosing or an additional||
1382|052|H|medication. Talk with your doctor if this medication stops||
1382|053|H|working well (such as your blood pressure readings remain high or||
1382|054|H|increase).||
1382|055|B|||
1382|056|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, dry mouth,||
1382|057|S|or constipation may occur. If any of these effects last or get||
1382|058|S|worse, tell your doctor or pharmacist promptly.||
1382|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
1382|060|S|slowly when rising from a sitting or lying position.||
1382|061|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
1382|062|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1382|063|S|substitute.||
1382|064|S|   Remember that this medication has been prescribed because your||
1382|065|S|doctor has judged that the benefit to you is greater than the||
1382|066|S|risk of side effects. Many people using this medication do not||
1382|067|S|have serious side effects.||
1382|068|S|   Tell your doctor right away if you have any serious side||
1382|069|S|effects, including: fainting, slow/irregular heartbeat,||
1382|070|S|mental/mood changes (such as irritability, depression).||
1382|071|S|   A very serious allergic reaction to this drug is rare.||
1382|072|S|However, get medical help right away if you notice any symptoms||
1382|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1382|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1382|075|S|breathing.||
1382|076|S|   This is not a complete list of possible side effects. If you||
1382|077|S|notice other effects not listed above, contact your doctor or||
1382|078|S|pharmacist.||
1382|079|S|   In the US -||
1382|080|S|   Call your doctor for medical advice about side effects. You||
1382|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1382|082|S|www.fda.gov/medwatch.||
1382|083|S|   In Canada - Call your doctor for medical advice about side||
1382|084|S|effects. You may report side effects to Health Canada at||
1382|085|S|1-866-234-2345.||
1382|086|B|||
1382|087|P|PRECAUTIONS:  Before taking clonidine, tell your doctor or||
1382|088|P|pharmacist if you are allergic to it (including having a rash||
1382|089|P|while using clonidine patches); or if you have any other||
1382|090|P|allergies. This product may contain inactive ingredients, which||
1382|091|P|can cause allergic reactions or other problems. Talk to your||
1382|092|P|pharmacist for more details.||
1382|093|P|   Before using this medication, tell your doctor or pharmacist||
1382|094|P|your medical history, especially of: kidney disease (such as on||
1382|095|P|dialysis), heart rhythm problems (such as slow/irregular||
1382|096|P|heartbeat, second- or third-degree atrioventricular block).||
1382|097|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1382|098|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1382|099|P|machinery, or do anything that needs alertness until you can do||
1382|100|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1382|101|P|are using marijuana (cannabis).||
1382|102|P|   Before having surgery, tell your doctor or dentist about all||
1382|103|P|the products you use (including prescription drugs,||
1382|104|P|nonprescription drugs, and herbal products).||
1382|105|P|   Contact lens wearers may need to use wetting eye drops since||
1382|106|P|this medication can cause dry eyes.||
1382|107|P|   Older adults may be more sensitive to the side effects of this||
1382|108|P|product, especially dizziness or drowsiness. These side effects||
1382|109|P|may increase the risk of falling.||
1382|110|P|   During pregnancy, this medication should be used only when||
1382|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
1382|112|P|   This medication passes into breast milk and may have||
1382|113|P|undesirable effects on a nursing infant. Consult your doctor||
1382|114|P|before breastfeeding.||
1382|115|B|||
1382|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1382|117|I|medications work or increase your risk for serious side effects.||
1382|118|I|This document does not contain all possible drug interactions.||
1382|119|I|Keep a list of all the products you use (including||
1382|120|I|prescription/nonprescription drugs and herbal products) and share||
1382|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
1382|122|I|the dosage of any medicines without your doctor's approval.||
1382|123|I|   Tell your doctor or pharmacist if you are using other products||
1382|124|I|that cause drowsiness such as opioid pain or cough relievers||
1382|125|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
1382|126|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
1382|127|I|zolpidem), muscle relaxants (such as carisoprodol,||
1382|128|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1382|129|I|diphenhydramine).||
1382|130|I|   Check the labels on all your medicines (such as allergy or||
1382|131|I|cough-and-cold products, diet aids, or NSAIDs such as ibuprofen,||
1382|132|I|naproxen) because they may contain ingredients that cause||
1382|133|I|drowsiness or increase your blood pressure. Ask your pharmacist||
1382|134|I|for more details.||
1382|135|B|||
1382|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1382|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1382|138|O|poison control center right away. US residents can call||
1382|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1382|140|O|Symptoms of overdose may include: severe dizziness/drowsiness,||
1382|141|O|fainting, slow/irregular heartbeat, slow/shallow breathing,||
1382|142|O|seizures.||
1382|143|B|||
1382|144|N|NOTES:  Do not share this medication with others.||
1382|145|N|   Lifestyle changes that may help this medication work better||
1382|146|N|include exercising, stopping smoking, and eating a||
1382|147|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1382|148|N|details.||
1382|149|N|   Check your blood pressure and pulse (heart rate) regularly||
1382|150|N|while taking this medication. Learn how to check your own blood||
1382|151|N|pressure and pulse at home, and share the results with your||
1382|152|N|doctor.||
1382|153|B|||
1382|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1382|155|D|remember. If it is near the time of the next dose, skip the||
1382|156|D|missed dose. Take your next dose at the regular time. Do not||
1382|157|D|double the dose to catch up. If you miss 2 or more doses in a||
1382|158|D|row, contact your doctor right away.||
1382|159|B|||
1382|160|R|STORAGE:  Store at room temperature away from light and moisture.||
1382|161|R|Do not store in the bathroom. Keep all medications away from||
1382|162|R|children and pets.||
1382|163|R|   Do not flush medications down the toilet or pour them into a||
1382|164|R|drain unless instructed to do so. Properly discard this product||
1382|165|R|when it is expired or no longer needed. Consult your pharmacist||
1382|166|R|or local waste disposal company.||
1382|167|B|||
1382|168|A|Information last revised May 2024.||
1382|169|A|Copyright(c) 2025 First Databank, Inc.||
1382|170|B|||
1383|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1383|002|Z|does NOT have all possible information about this product. This||
1383|003|Z|information does not assure that this product is safe, effective,||
1383|004|Z|or appropriate for you. This information is not individual||
1383|005|Z|medical advice and does not substitute for the advice of your||
1383|006|Z|health care professional. Always ask your health care||
1383|007|Z|professional for complete information about this product and your||
1383|008|Z|specific health needs.||
1383|009|B|||
1383|010|T|DROSPIRENONE/ETHINYL ESTRADIOL/FOLATE SUPPLEMENT 21/7 - ORAL||
1383|011|F|(droe-SPYE-re-none/ETH-i-nil ES-tra-DYE-ol/FOE-late)||
1383|012|B|||
1383|013|C|COMMON BRAND NAME(S): Safyral||
1383|014|B|||
1383|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
1383|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
1383|017|W|stroke, heart attack, blood clots, and high blood pressure from||
1383|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
1383|019|W|of these serious problems increases with age and with the number||
1383|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
1383|021|B|||
1383|022|U|USES:  This combination hormone medication is used to prevent||
1383|023|U|pregnancy. It contains 2 hormones: an estrogen (ethinyl||
1383|024|U|estradiol) and a progestin (drospirenone).||
1383|025|U|   This product also contains a folate supplement (such as||
1383|026|U|l-methylfolate, levomefolate). Folate is a B-vitamin that women||
1383|027|U|of childbearing age use to help prevent spinal cord defects in an||
1383|028|U|unborn baby. The folate supplement in this medication, along with||
1383|029|U|a diet rich in folate, lowers this risk if you become pregnant||
1383|030|U|while taking this drug or soon after you stop taking it.||
1383|031|U|   Besides preventing pregnancy, birth control pills may make||
1383|032|U|your periods more regular, and may decrease blood loss, painful||
1383|033|U|periods, and the risk of ovarian cysts.||
1383|034|U|   This medication does not protect against sexually transmitted||
1383|035|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1383|036|U|an effective barrier method (latex or polyurethane condom/dental||
1383|037|U|dams) during sexual activity will help to decrease your risk of||
1383|038|U|infection.||
1383|039|B|||
1383|040|V|OTHER USES:  This section contains uses of this drug that are not||
1383|041|V|listed in the approved professional labeling for the drug but||
1383|042|V|that may be prescribed by your health care professional. Use this||
1383|043|V|drug for a condition that is listed in this section only if it||
1383|044|V|has been so prescribed by your health care professional.||
1383|045|V|   Birth control pills may also be used for premenstrual||
1383|046|V|dysphoric disorder (PMDD) or moderate acne if you have chosen to||
1383|047|V|use birth control pills as your method of pregnancy prevention.||
1383|048|B|||
1383|049|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1383|050|H|your pharmacist before you start taking this product and each||
1383|051|H|time you get a refill. The leaflet contains very important advice||
1383|052|H|about when to take your pills and what to do if you miss a dose.||
1383|053|H|If you have any questions, ask your doctor or pharmacist.||
1383|054|H|   Take this medication by mouth with or without food as directed||
1383|055|H|by your doctor, usually once daily. Pick a time of day that is||
1383|056|H|easy for you to remember, and take your pill at the same time||
1383|057|H|each day. Taking this medication after your evening meal or at||
1383|058|H|bedtime may help decrease stomach upset and nausea.||
1383|059|H|   It is very important to keep taking this medication exactly as||
1383|060|H|prescribed by your doctor. Follow the package instructions to||
1383|061|H|find the first tablet, start with the first tablet in the pack,||
1383|062|H|and take them in the correct order. Do not skip any doses.||
1383|063|H|Pregnancy is more likely if you miss pills, start a new pack||
1383|064|H|late, or take your pill at a different time of the day than||
1383|065|H|usual.||
1383|066|H|   Vomiting or diarrhea can prevent your birth control pills from||
1383|067|H|working well. If you have vomiting or diarrhea, you may need to||
1383|068|H|use a backup birth control method (such as condoms, spermicide).||
1383|069|H|Follow the directions in the Patient Information Leaflet and||
1383|070|H|check with your doctor or pharmacist for more details.||
1383|071|H|   Your pill pack contains 21 pills with active medication||
1383|072|H|(hormones and folate). It also contains 7 reminder pills (without||
1383|073|H|hormones, but with folate) at the end of the pack. Take one||
1383|074|H|active pill (with hormones) once daily for 21 days in a row.||
1383|075|H|After you have taken the last active pill, take one reminder pill||
1383|076|H|(without hormones) once daily for 7 days in a row unless||
1383|077|H|otherwise directed by your doctor. You should have your period||
1383|078|H|during the fourth week of the cycle. After you have taken the||
1383|079|H|last reminder tablet in the pack, start a new pack the next day||
1383|080|H|even if your period is continuing or if you do not have your||
1383|081|H|period. If you do not get your period, consult your doctor.||
1383|082|H|   If this is the first time you are using this medication and||
1383|083|H|you are not switching from another form of hormonal birth control||
1383|084|H|(such as patch, other birth control pills), take the first tablet||
1383|085|H|in the pack on the first Sunday following the beginning of your||
1383|086|H|menstrual period or on the first day of your period. If your||
1383|087|H|period begins on a Sunday, begin taking this medication on that||
1383|088|H|day. For the first cycle of use only, use a backup form of||
1383|089|H|non-hormonal birth control (such as condoms, spermicide) for the||
1383|090|H|first 7 days to prevent pregnancy until the medication has enough||
1383|091|H|time to work. If you start on the first day of your period, you||
1383|092|H|do not need to use backup birth control the first week.||
1383|093|H|   Ask your doctor or pharmacist for information about how to||
1383|094|H|switch from other forms of hormonal birth control (such as patch,||
1383|095|H|vaginal ring, other birth control pills) to this product. If any||
1383|096|H|information is unclear, consult the Patient Information Leaflet||
1383|097|H|or your doctor or pharmacist.||
1383|098|B|||
1383|099|S|SIDE EFFECTS:  See also Precautions section.||
1383|100|S|   Nausea, vomiting, headache, abdominal cramps, bloating, breast||
1383|101|S|tenderness, swelling of the ankles/feet (retaining fluid), or||
1383|102|S|weight change may occur. Vaginal bleeding between periods||
1383|103|S|(spotting) or missed/irregular periods may occur, especially||
1383|104|S|during the first few months of use. If any of these effects last||
1383|105|S|or get worse, tell your doctor or pharmacist promptly. If you||
1383|106|S|miss 2 periods in a row (or 1 period if the pill has not been||
1383|107|S|used properly), contact your doctor for a pregnancy test.||
1383|108|S|   Remember that this medication has been prescribed because your||
1383|109|S|doctor has judged that the benefit to you is greater than the||
1383|110|S|risk of side effects. Many people using this medication do not||
1383|111|S|have serious side effects.||
1383|112|S|   This medication may raise your blood pressure. Check your||
1383|113|S|blood pressure regularly and tell your doctor if the results are||
1383|114|S|high.||
1383|115|S|   Tell your doctor right away if you have any serious side||
1383|116|S|effects, including: lumps in the breast, mental/mood changes||
1383|117|S|(such as new/worsening depression), unusual changes in vaginal||
1383|118|S|bleeding (such as continuous spotting, sudden heavy bleeding),||
1383|119|S|severe stomach/abdominal pain, symptoms of a high potassium blood||
1383|120|S|level (such as muscle weakness, slow/irregular heartbeat), dark||
1383|121|S|urine, yellowing eyes/skin.||
1383|122|S|   This medication may rarely cause serious (sometimes fatal)||
1383|123|S|problems from blood clots (such as heart attack, stroke, blood||
1383|124|S|clots in the lungs or legs). Get medical help right away if you||
1383|125|S|have: pain/swelling/warmth in the groin/calf, shortness of||
1383|126|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
1383|127|S|sweating, sudden dizziness/fainting, confusion, trouble speaking,||
1383|128|S|weakness on one side of the body, sudden vision changes,||
1383|129|S|sudden/severe headaches.||
1383|130|S|   A very serious allergic reaction to this drug is rare.||
1383|131|S|However, get medical help right away if you notice any symptoms||
1383|132|S|of a serious allergic reaction, including: rash, itching/swelling||
1383|133|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1383|134|S|breathing.||
1383|135|S|   This is not a complete list of possible side effects. If you||
1383|136|S|notice other effects not listed above, contact your doctor or||
1383|137|S|pharmacist.||
1383|138|S|   In the US -||
1383|139|S|   Call your doctor for medical advice about side effects. You||
1383|140|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1383|141|S|www.fda.gov/medwatch.||
1383|142|S|   In Canada - Call your doctor for medical advice about side||
1383|143|S|effects. You may report side effects to Health Canada at||
1383|144|S|1-866-234-2345.||
1383|145|B|||
1383|146|P|PRECAUTIONS:  See also Warning section.||
1383|147|P|   Before taking this medication, tell your doctor or pharmacist||
1383|148|P|if you are allergic to drospirenone, ethinyl estradiol, or folate||
1383|149|P|supplements; or if you have any other allergies. This product may||
1383|150|P|contain inactive ingredients, which can cause allergic reactions||
1383|151|P|or other problems. Talk to your pharmacist for more details.||
1383|152|P|   Before using this product, tell your doctor or pharmacist your||
1383|153|P|medical history, especially of: adrenal gland problems, blood||
1383|154|P|clots (for example, in the legs, eyes, lungs), blood clotting||
1383|155|P|disorders (such as protein C or protein S deficiency), high blood||
1383|156|P|pressure, high cholesterol or triglyceride (blood fat) levels,||
1383|157|P|abnormal breast exam, cancer (especially endometrial or breast||
1383|158|P|cancer), depression, diabetes, family or personal history of a||
1383|159|P|certain swelling disorder (angioedema), gallbladder problems,||
1383|160|P|severe headaches/migraines, heart problems (such as heart valve||
1383|161|P|disease, irregular heartbeat, previous heart attack), kidney||
1383|162|P|disease, liver disease (including tumors), obesity, history of||
1383|163|P|yellowing eyes/skin (jaundice) during pregnancy or while using||
1383|164|P|hormonal birth control (such as pills, patch), swelling (edema),||
1383|165|P|stroke, thyroid problems, unexplained vaginal bleeding.||
1383|166|P|   If you have diabetes, this medication may affect your blood||
1383|167|P|sugar. Check your blood sugar regularly as directed and share the||
1383|168|P|results with your doctor. Tell your doctor right away if you have||
1383|169|P|symptoms of high blood sugar such as increased thirst/urination.||
1383|170|P|Your doctor may need to adjust your diabetes medication, exercise||
1383|171|P|program, or diet.||
1383|172|P|   Tell your doctor if you just had or will be having surgery or||
1383|173|P|if you will be confined to a chair or bed for a long time (such||
1383|174|P|as on a long plane flight). These conditions increase your risk||
1383|175|P|of getting blood clots, especially if you are using hormonal||
1383|176|P|birth control. You may need to stop this medication for a time or||
1383|177|P|take special precautions.||
1383|178|P|   Before having surgery, tell your doctor or dentist about all||
1383|179|P|the products you use (including prescription drugs,||
1383|180|P|nonprescription drugs, and herbal products).||
1383|181|P|   This product may increase your potassium levels. Before using||
1383|182|P|potassium supplements or salt substitutes that contain potassium,||
1383|183|P|consult your doctor or pharmacist.||
1383|184|P|   This medication may cause blotchy, dark areas on your face and||
1383|185|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
1383|186|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
1383|187|P|wear protective clothing when outdoors.||
1383|188|P|   If you are nearsighted or wear contact lenses, you may develop||
1383|189|P|vision problems or trouble wearing your contact lenses. Contact||
1383|190|P|your eye doctor if these problems occur.||
1383|191|P|   It may take longer for you to become pregnant after you stop||
1383|192|P|taking birth control pills. Consult your doctor.||
1383|193|P|   This medication should not be used during pregnancy. If you||
1383|194|P|become pregnant or think you may be pregnant, tell your doctor||
1383|195|P|right away. If you have just given birth or had a pregnancy||
1383|196|P|loss/abortion after the first 3 months, talk with your doctor||
1383|197|P|about reliable forms of birth control, and find out when it is||
1383|198|P|safe to start using birth control that contains a form of||
1383|199|P|estrogen, such as this medication.||
1383|200|P|   A small amount of this medication passes into breast milk and||
1383|201|P|may have undesirable effects on a nursing infant. Consult your||
1383|202|P|doctor before breastfeeding.||
1383|203|B|||
1383|204|I|DRUG INTERACTIONS:  See also Precautions section.||
1383|205|I|   Drug interactions may change how your medications work or||
1383|206|I|increase your risk for serious side effects. This document does||
1383|207|I|not contain all possible drug interactions. Keep a list of all||
1383|208|I|the products you use (including prescription/nonprescription||
1383|209|I|drugs and herbal products) and share it with your doctor and||
1383|210|I|pharmacist. Do not start, stop, or change the dosage of any||
1383|211|I|medicines without your doctor's approval.||
1383|212|I|   Some products that may interact with this drug include:||
1383|213|I|aromatase inhibitors (such as anastrozole, exemestane,||
1383|214|I|letrozole), atazanavir/cobicistat, fezolinetant, ospemifene,||
1383|215|I|tamoxifen, tranexamic acid.||
1383|216|I|   Drospirenone may raise your potassium blood level. Tell your||
1383|217|I|doctor if you are regularly taking other drugs/products that can||
1383|218|I|also raise your potassium level (including aliskiren, ACE||
1383|219|I|inhibitors such as benazepril/lisinopril, angiotensin receptor||
1383|220|I|blockers such as losartan/valsartan, heparin, NSAIDs such as||
1383|221|I|ibuprofen/naproxen, potassium-sparing "water pills"/diuretics||
1383|222|I|such as spironolactone/triamterene).||
1383|223|I|   Some drugs may cause hormonal birth control to work less well||
1383|224|I|by decreasing the amount of birth control hormones in your body.||
1383|225|I|This effect can result in pregnancy. Examples include||
1383|226|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
1383|227|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
1383|228|I|seizures (such as barbiturates, carbamazepine, felbamate,||
1383|229|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
1383|230|I|nevirapine), among others.||
1383|231|I|   Tell your doctor when you start any new drug, and discuss if||
1383|232|I|you should use reliable backup birth control. Also tell your||
1383|233|I|doctor if you have any new spotting or breakthrough bleeding,||
1383|234|I|because these may be signs that your birth control is not working||
1383|235|I|well.||
1383|236|I|   This medication may interfere with certain lab tests (such as||
1383|237|I|blood clotting factors, thyroid), possibly causing false test||
1383|238|I|results. Make sure lab personnel and all your doctors know you||
1383|239|I|use this drug.||
1383|240|B|||
1383|241|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1383|242|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1383|243|O|poison control center right away. US residents can call||
1383|244|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1383|245|O|Symptoms of overdose may include: severe nausea and vomiting,||
1383|246|O|sudden/unusual vaginal bleeding.||
1383|247|B|||
1383|248|N|NOTES:  Do not share this medication with others.||
1383|249|N|   Regular complete physical exams which include lab and/or||
1383|250|N|medical tests (such as potassium blood level, blood pressure,||
1383|251|N|breast exam, pelvic exam, Pap smear) should be done while you are||
1383|252|N|taking this medication. Follow your doctor's instructions for||
1383|253|N|examining your breasts, and report any lumps right away. Keep all||
1383|254|N|medical and lab appointments. Consult your doctor for more||
1383|255|N|details.||
1383|256|B|||
1383|257|D|MISSED DOSE:  Refer to the product package information for advice||
1383|258|D|on missed doses. You may need to use backup birth control (such||
1383|259|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
1383|260|D|pharmacist if you have any questions.||
1383|261|D|   If you often forget to take your pills as directed, contact||
1383|262|D|your doctor to discuss switching to another form of birth||
1383|263|D|control.||
1383|264|B|||
1383|265|R|STORAGE:  Store at room temperature away from light and moisture.||
1383|266|R|Do not store in the bathroom. Keep all medications away from||
1383|267|R|children and pets.||
1383|268|R|   Do not flush medications down the toilet or pour them into a||
1383|269|R|drain unless instructed to do so. Properly discard this product||
1383|270|R|when it is expired or no longer needed. Consult your pharmacist||
1383|271|R|or local waste disposal company.||
1383|272|B|||
1383|273|A|Information last revised October 2025.||
1383|274|A|Copyright(c) 2025 First Databank, Inc.||
1383|275|B|||
1384|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1384|002|Z|does NOT have all possible information about this product. This||
1384|003|Z|information does not assure that this product is safe, effective,||
1384|004|Z|or appropriate for you. This information is not individual||
1384|005|Z|medical advice and does not substitute for the advice of your||
1384|006|Z|health care professional. Always ask your health care||
1384|007|Z|professional for complete information about this product and your||
1384|008|Z|specific health needs.||
1384|009|B|||
1384|010|T|GLYCOPYRROLATE SOLUTION - ORAL||
1384|011|F|(GLYE-koe-PIR-oh-late)||
1384|012|B|||
1384|013|C|COMMON BRAND NAME(S): Cuvposa||
1384|014|B|||
1384|015|U|USES:  Glycopyrrolate solution is used to reduce excessive||
1384|016|U|drooling caused by medical conditions (such as cerebral palsy).||
1384|017|U|This medication works by decreasing the amount of saliva you||
1384|018|U|make. Glycopyrrolate belongs to a class of drugs known as||
1384|019|U|anticholinergics.||
1384|020|B|||
1384|021|H|HOW TO USE:  Read the Patient and Caregiver Information Leaflet||
1384|022|H|if available from your pharmacist before you start taking||
1384|023|H|glycopyrrolate and each time you get a refill. If you have any||
1384|024|H|questions, ask your doctor or pharmacist.||
1384|025|H|   Take this medication by mouth as directed by your doctor,||
1384|026|H|usually 3 times a day. Take it on an empty stomach, at least 1||
1384|027|H|hour before or 2 hours after a meal. Carefully measure the dose||
1384|028|H|using a special measuring device/spoon. Do not use a household||
1384|029|H|spoon because you may not get the correct dose. If your||
1384|030|H|medication comes in an oral dosing syringe, use the syringe to||
1384|031|H|measure the dose.||
1384|032|H|   The dosage is based on your medical condition and response to||
1384|033|H|treatment. Children's dosage is also based on weight. To reduce||
1384|034|H|the risk of side effects, your doctor may direct you to start||
1384|035|H|this medication at a low dose and gradually increase the dose.||
1384|036|H|Follow your doctor's instructions carefully.||
1384|037|H|   Do not increase the dose or take this drug more often without||
1384|038|H|your doctor's approval. Your condition will not improve any||
1384|039|H|faster and your risk of side effects will increase.||
1384|040|H|   Tell your doctor if your condition does not get better or if||
1384|041|H|it gets worse.||
1384|042|B|||
1384|043|S|SIDE EFFECTS:  Drowsiness, dizziness, blurred vision, dry mouth,||
1384|044|S|stuffy nose, or constipation may occur. If any of these effects||
1384|045|S|last or get worse, tell your doctor or pharmacist promptly.||
1384|046|S|   To prevent constipation, eat dietary fiber, drink enough||
1384|047|S|water, and exercise. You may also need to take a laxative. Ask||
1384|048|S|your pharmacist which type of laxative is right for you.||
1384|049|S|   Remember that this medication has been prescribed because your||
1384|050|S|doctor has judged that the benefit to you is greater than the||
1384|051|S|risk of side effects. Many people using this medication do not||
1384|052|S|have serious side effects.||
1384|053|S|   Tell your doctor right away if you have any serious side||
1384|054|S|effects, including: constipation that doesn't go away, nausea||
1384|055|S|that doesn't stop, stomach/abdominal bloating or pain, vomiting,||
1384|056|S|diarrhea, decreased sweating, dry/hot/flushed skin,||
1384|057|S|fast/irregular heartbeat, mental/mood changes (such as confusion,||
1384|058|S|hallucinations, agitation, nervousness, unusual excitement),||
1384|059|S|difficulty urinating/inability to urinate.||
1384|060|S|   Get medical help right away if you have any very serious side||
1384|061|S|effects, including: eye pain/swelling/redness, vision changes||
1384|062|S|(such as seeing rainbows around lights at night).||
1384|063|S|   A very serious allergic reaction to this drug is rare.||
1384|064|S|However, get medical help right away if you notice any symptoms||
1384|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1384|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1384|067|S|breathing.||
1384|068|S|   This is not a complete list of possible side effects. If you||
1384|069|S|notice other effects not listed above, contact your doctor or||
1384|070|S|pharmacist.||
1384|071|S|   In the US -||
1384|072|S|   Call your doctor for medical advice about side effects. You||
1384|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1384|074|S|www.fda.gov/medwatch.||
1384|075|S|   In Canada - Call your doctor for medical advice about side||
1384|076|S|effects. You may report side effects to Health Canada at||
1384|077|S|1-866-234-2345.||
1384|078|B|||
1384|079|P|PRECAUTIONS:  Before taking glycopyrrolate, tell your doctor or||
1384|080|P|pharmacist if you are allergic to it; or if you have any other||
1384|081|P|allergies. This product may contain inactive ingredients, which||
1384|082|P|can cause allergic reactions or other problems. Talk to your||
1384|083|P|pharmacist for more details.||
1384|084|P|   Before using this medication, tell your doctor or pharmacist||
1384|085|P|your medical history, especially of: personal or family history||
1384|086|P|of glaucoma (angle-closure type), problems with urination (such||
1384|087|P|as urinary tract blockage, severely enlarged prostate),||
1384|088|P|stomach/intestinal problems (such as chronic constipation, slow||
1384|089|P|gut, intestinal blockage/infection, ulcerative colitis),||
1384|090|P|myasthenia gravis, kidney problems.||
1384|091|P|   This drug may make you dizzy or drowsy or blur your vision.||
1384|092|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1384|093|P|drowsy. Do not drive, use machinery, or do anything that needs||
1384|094|P|alertness or clear vision until you can do it safely. Limit||
1384|095|P|alcoholic beverages. Talk to your doctor if you are using||
1384|096|P|marijuana (cannabis).||
1384|097|P|   This medication may make you sweat less, making you more||
1384|098|P|likely to get heat stroke. Avoid doing things that may cause you||
1384|099|P|to overheat, such as hard work or exercise in hot weather, or||
1384|100|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1384|101|P|and dress lightly. If you overheat, quickly look for a place to||
1384|102|P|cool down and rest. Get medical help right away if you have a||
1384|103|P|fever that does not go away, mental/mood changes, headache, or||
1384|104|P|dizziness.||
1384|105|P|   Before having surgery, tell your doctor or dentist about all||
1384|106|P|the products you use (including prescription drugs,||
1384|107|P|nonprescription drugs, and herbal products).||
1384|108|P|   Older adults may be more sensitive to this drug's side||
1384|109|P|effects, especially drowsiness, confusion, unusual excitement,||
1384|110|P|constipation, and urination problems.||
1384|111|P|   During pregnancy, this medication should be used only when||
1384|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
1384|113|P|   It is unknown if this drug passes into breast milk. Consult||
1384|114|P|your doctor before breastfeeding.||
1384|115|B|||
1384|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1384|117|I|medications work or increase your risk for serious side effects.||
1384|118|I|This document does not contain all possible drug interactions.||
1384|119|I|Keep a list of all the products you use (including||
1384|120|I|prescription/nonprescription drugs and herbal products) and share||
1384|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
1384|122|I|the dosage of any medicines without your doctor's approval.||
1384|123|I|   Some products that may interact with this drug include:||
1384|124|I|potassium chloride tablets/capsules, pramlintide.||
1384|125|I|   Tell your doctor or pharmacist if you are using other products||
1384|126|I|that cause drowsiness such as opioid pain or cough relievers||
1384|127|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
1384|128|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
1384|129|I|zolpidem), muscle relaxants (such as carisoprodol,||
1384|130|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1384|131|I|diphenhydramine).||
1384|132|I|   Check the labels on all your medicines (such as allergy or||
1384|133|I|cough-and-cold products, diet aids) because they may contain||
1384|134|I|ingredients that cause drowsiness or a fast heartbeat. Ask your||
1384|135|I|pharmacist about using those products safely.||
1384|136|I|   This medication may interfere with certain lab tests (such as||
1384|137|I|gastric secretion tests), possibly causing false test results.||
1384|138|I|Make sure lab personnel and all your doctors know you use this||
1384|139|I|drug.||
1384|140|B|||
1384|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1384|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1384|143|O|poison control center right away. US residents can call||
1384|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1384|145|O|Symptoms of overdose may include: fever, mental/mood changes||
1384|146|O|(such as confusion, unusual excitement), seizures, coma.||
1384|147|B|||
1384|148|N|NOTES:  Do not share this medication with others.||
1384|149|B|||
1384|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1384|151|D|remember. If it is near the time of the next dose, skip the||
1384|152|D|missed dose. Take your next dose at the regular time. Do not||
1384|153|D|double the dose to catch up.||
1384|154|B|||
1384|155|R|STORAGE:  Different brands of this medication have different||
1384|156|R|storage needs. Check the product package for instructions on how||
1384|157|R|to store your brand, or ask your pharmacist. Keep all medications||
1384|158|R|away from children and pets.||
1384|159|R|   Do not flush medications down the toilet or pour them into a||
1384|160|R|drain unless instructed to do so. Properly discard this product||
1384|161|R|when it is expired or no longer needed. Consult your pharmacist||
1384|162|R|or local waste disposal company.||
1384|163|B|||
1384|164|A|Information last revised July 2025.||
1384|165|A|Copyright(c) 2025 First Databank, Inc.||
1384|166|B|||
1386|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1386|002|Z|does NOT have all possible information about this product. This||
1386|003|Z|information does not assure that this product is safe, effective,||
1386|004|Z|or appropriate for you. This information is not individual||
1386|005|Z|medical advice and does not substitute for the advice of your||
1386|006|Z|health care professional. Always ask your health care||
1386|007|Z|professional for complete information about this product and your||
1386|008|Z|specific health needs.||
1386|009|B|||
1386|010|T|ALITRETINOIN - ORAL||
1386|011|F|(AL-i-TRET-i-noyn)||
1386|012|B|||
1386|013|W|WARNING:  Women who are pregnant must not use alitretinoin. Women||
1386|014|W|must avoid becoming pregnant while taking this medication and for||
1386|015|W|one month after stopping treatment. It can cause serious (even||
1386|016|W|fatal) birth defects, miscarriage, or premature birth of the||
1386|017|W|baby. Talk with your doctor about the risks and benefits of||
1386|018|W|taking this medication and your birth control options. Read and||
1386|019|W|sign the Patient Informed Consent Form provided by your doctor.||
1386|020|W|   Women who are able to have children must use two reliable||
1386|021|W|forms of birth control for 1 month before starting alitretinoin,||
1386|022|W|during use, and for at least 1 month after treatment has stopped.||
1386|023|W|Do not use "minipills" (non-estrogen-containing pills) for birth||
1386|024|W|control because they may not work as well with this drug.||
1386|025|W|   Women who are able to have children must also meet the||
1386|026|W|following requirements: test negative on 2 pregnancy tests before||
1386|027|W|starting treatment; start treatment on the second or third day of||
1386|028|W|the next normal menstrual period; have monthly pregnancy tests||
1386|029|W|during treatment and for one month after stopping treatment.||
1386|030|W|   Alitretinoin has been rarely linked to increased pressure in||
1386|031|W|the brain (benign intracranial hypertension). Stop taking||
1386|032|W|alitretinoin and tell your doctor right away if you develop||
1386|033|W|headache that doesn't go away, nausea, vomiting, or vision||
1386|034|W|changes (such as blurred vision).||
1386|035|B|||
1386|036|U|USES:  This medication is used by adults to treat severe hand||
1386|037|U|eczema that has not improved with other treatments (such as||
1386|038|U|corticosteroids applied to the skin). Alitretinoin belongs to a||
1386|039|U|class of drugs known as retinoids, which are related to vitamin||
1386|040|U|A. It works by decreasing the production of certain substances||
1386|041|U|that cause skin inflammation.||
1386|042|B|||
1386|043|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1386|044|H|from your pharmacist before you start taking alitretinoin and||
1386|045|H|each time you get a refill. If you have any questions, ask your||
1386|046|H|doctor or pharmacist.||
1386|047|H|   Take this medication by mouth as directed by your doctor,||
1386|048|H|usually once daily with a meal.||
1386|049|H|   The dosage is based on your medical condition and response to||
1386|050|H|treatment.||
1386|051|H|   Take this medication regularly in order to get the most||
1386|052|H|benefit from it. To help you remember, take it at the same time||
1386|053|H|each day.||
1386|054|H|   Since this drug can be absorbed through the skin and lungs and||
1386|055|H|may harm an unborn baby, women who are pregnant or who may become||
1386|056|H|pregnant should not handle this medication or breathe the dust||
1386|057|H|from the capsules.||
1386|058|H|   Tell your doctor if your condition lasts or gets worse. It may||
1386|059|H|take up to 2 months to notice improvement.||
1386|060|B|||
1386|061|S|SIDE EFFECTS:  Headache, flushing, dry eyes, or dry lips/skin may||
1386|062|S|occur. If any of these effects last or get worse, tell your||
1386|063|S|doctor or pharmacist promptly.||
1386|064|S|   To relieve dry eyes, you may use a lubricating eye ointment or||
1386|065|S|tear replacement eye drops. Ask your pharmacist for details. If||
1386|066|S|you wear contact lenses and get dry eyes, you may need to wear||
1386|067|S|glasses while using this medication.||
1386|068|S|   Remember that this medication has been prescribed because your||
1386|069|S|doctor has judged that the benefit to you is greater than the||
1386|070|S|risk of side effects. Many people using this medication do not||
1386|071|S|have serious side effects.||
1386|072|S|   Tell your doctor right away if you have any serious side||
1386|073|S|effects, including: mental/mood changes (such as depression,||
1386|074|S|anxiety, thoughts of suicide), back/joint/muscle pain.||
1386|075|S|   Stop taking alitretinoin and tell your doctor right away if||
1386|076|S|you have any very serious side effects, including: headache that||
1386|077|S|is severe or doesn't go away, nausea/vomiting that doesn't stop,||
1386|078|S|abdominal pain, bloody/severe diarrhea, bleeding from the rectum,||
1386|079|S|vision changes (such as blurred/double vision, decreased vision).||
1386|080|S|   A very serious allergic reaction to this drug is rare.||
1386|081|S|However, get medical help right away if you notice any symptoms||
1386|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1386|083|S|(especially of the face/tongue/throat), dizziness, trouble||
1386|084|S|breathing.||
1386|085|S|   This is not a complete list of possible side effects. If you||
1386|086|S|notice other effects not listed above, contact your doctor or||
1386|087|S|pharmacist.||
1386|088|S|   In the US -||
1386|089|S|   Call your doctor for medical advice about side effects. You||
1386|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1386|091|S|www.fda.gov/medwatch.||
1386|092|S|   In Canada - Call your doctor for medical advice about side||
1386|093|S|effects. You may report side effects to Health Canada at||
1386|094|S|1-866-234-2345.||
1386|095|B|||
1386|096|P|PRECAUTIONS:  Before taking alitretinoin, tell your doctor or||
1386|097|P|pharmacist if you are allergic to it; or to vitamin A-related||
1386|098|P|drugs (other retinoids such as isotretinoin); or if you have any||
1386|099|P|other allergies. This product may contain inactive ingredients||
1386|100|P|(such as soy), which can cause allergic reactions or other||
1386|101|P|problems. Talk to your pharmacist for more details.||
1386|102|P|   Before using this medication, tell your doctor or pharmacist||
1386|103|P|your medical history, especially of: diabetes, high||
1386|104|P|cholesterol/triglycerides, high levels of vitamin A, kidney||
1386|105|P|disease, liver disease, mental/mood problems (such as||
1386|106|P|depression), thyroid disease.||
1386|107|P|   Do not donate blood while taking this drug and for at least 1||
1386|108|P|month after stopping treatment. This will lessen the chance of||
1386|109|P|your blood being given to a pregnant woman.||
1386|110|P|   This medication may make you more sensitive to the sun. Limit||
1386|111|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1386|112|P|sunscreen and wear protective clothing when outdoors. Tell your||
1386|113|P|doctor right away if you get sunburned or have skin||
1386|114|P|blisters/redness.||
1386|115|P|   Alitretinoin may cause vision changes, including decreased||
1386|116|P|night vision. Do not drive, use machinery, or do anything that||
1386|117|P|needs clear vision (especially at night) until you can do it||
1386|118|P|safely.||
1386|119|P|   Before having surgery, tell your doctor or dentist about all||
1386|120|P|the products you use (including prescription drugs,||
1386|121|P|nonprescription drugs, and herbal products).||
1386|122|P|   This drug must not be used during pregnancy. It may harm an||
1386|123|P|unborn baby. Females must use two reliable forms of birth control||
1386|124|P|for 1 month before starting alitretinoin, during use, and for at||
1386|125|P|least 1 month after treatment has stopped. If you become pregnant||
1386|126|P|or think you may be pregnant, tell your doctor right away. See||
1386|127|P|also Warning section.||
1386|128|P|   Since this drug can be absorbed through the skin and lungs and||
1386|129|P|may harm an unborn baby, women who are pregnant or who may become||
1386|130|P|pregnant should not handle this medication or breathe the dust||
1386|131|P|from the capsules.||
1386|132|P|   It is unknown if this medication passes into breast milk.||
1386|133|P|However, similar drugs pass into breast milk. Breastfeeding is||
1386|134|P|not recommended while using this medication. Consult your doctor||
1386|135|P|before breastfeeding.||
1386|136|B|||
1386|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1386|138|I|medications work or increase your risk for serious side effects.||
1386|139|I|This document does not contain all possible drug interactions.||
1386|140|I|Keep a list of all the products you use (including||
1386|141|I|prescription/nonprescription drugs and herbal products) and share||
1386|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
1386|143|I|the dosage of any medicines without your doctor's approval.||
1386|144|I|   Some products that may interact with this drug include:||
1386|145|I|tetracycline antibiotics, vitamin A.||
1386|146|I|   Do not use "minipills" (non-estrogen-containing pills) for||
1386|147|I|birth control because they may not work as well with this drug.||
1386|148|I|Also, some drugs may cause hormonal birth control to work less||
1386|149|I|well by decreasing the amount of birth control hormones in your||
1386|150|I|body. Examples include griseofulvin, modafinil, rifamycins (such||
1386|151|I|as rifampin, rifabutin), St. John's wort, among others. See also||
1386|152|I|Warning section.||
1386|153|B|||
1386|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1386|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1386|156|O|poison control center right away. US residents can call||
1386|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1386|158|O|Symptoms of overdose may include: severe headache, diarrhea,||
1386|159|O|facial flushing.||
1386|160|B|||
1386|161|N|NOTES:  Do not share this medication with others.||
1386|162|N|   Lab and/or medical tests (such as pregnancy tests,||
1386|163|N|cholesterol/triglyceride levels, liver function) must be done||
1386|164|N|before you start taking this medication and while you are taking||
1386|165|N|it. Keep all medical and lab appointments. Consult your doctor||
1386|166|N|for more details.||
1386|167|B|||
1386|168|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1386|169|D|remember. If it is near the time of your next dose, skip the||
1386|170|D|missed dose. Take your next dose at the regular time. Do not||
1386|171|D|double the dose to catch up.||
1386|172|B|||
1386|173|R|STORAGE:  Store at room temperature away from light and moisture.||
1386|174|R|Do not store in the bathroom. Keep all medications away from||
1386|175|R|children and pets.||
1386|176|R|   Do not flush medications down the toilet or pour them into a||
1386|177|R|drain unless instructed to do so. Properly discard this product||
1386|178|R|when it is expired or no longer needed. Consult your pharmacist||
1386|179|R|or local waste disposal company.||
1386|180|B|||
1386|181|A|Information last revised April 2025.||
1386|182|A|Copyright(c) 2025 First Databank, Inc.||
1386|183|B|||
1387|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1387|002|Z|does NOT have all possible information about this product. This||
1387|003|Z|information does not assure that this product is safe, effective,||
1387|004|Z|or appropriate for you. This information is not individual||
1387|005|Z|medical advice and does not substitute for the advice of your||
1387|006|Z|health care professional. Always ask your health care||
1387|007|Z|professional for complete information about this product and your||
1387|008|Z|specific health needs.||
1387|009|B|||
1387|010|T|ALCAFTADINE - OPHTHALMIC||
1387|011|F|(al-KAF-ta-deen)||
1387|012|B|||
1387|013|C|COMMON BRAND NAME(S): Lastacaft||
1387|014|B|||
1387|015|U|USES:  This medication is used to prevent itching of the eyes due||
1387|016|U|to allergies. Alcaftadine is an antihistamine. It works by||
1387|017|U|blocking a certain natural substance (histamine) that causes||
1387|018|U|allergic symptoms.||
1387|019|U|   Do not use this medication to treat red or irritated eyes due||
1387|020|U|to wearing contact lenses. Contact your doctor for further||
1387|021|U|instructions if this occurs.||
1387|022|B|||
1387|023|H|HOW TO USE:  If you are using the over-the-counter product to||
1387|024|H|self-treat, read and follow all directions on the product package||
1387|025|H|before taking this medication. If you have any questions, consult||
1387|026|H|your pharmacist. If your doctor has prescribed this medication,||
1387|027|H|take it as directed.||
1387|028|H|   Use this medication in the affected eye(s) as directed by your||
1387|029|H|doctor, usually once a day.||
1387|030|H|   Wash your hands before each use. To avoid contamination, do||
1387|031|H|not touch the dropper tip or let it touch your eye or any other||
1387|032|H|surface.||
1387|033|H|   The preservative in this product may be absorbed by contact||
1387|034|H|lenses. If you wear contact lenses, remove them before using this||
1387|035|H|medication and keep them out of your eyes for at least 10 minutes||
1387|036|H|after each dose. Do not wear contact lenses if your eyes are red.||
1387|037|H|   Tilt your head back, look upward, and pull down the lower||
1387|038|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1387|039|H|and place one drop into the pouch as directed by your doctor.||
1387|040|H|Look downward, gently close your eyes, and place one finger at||
1387|041|H|the corner of your eye (near the nose). Apply gentle pressure for||
1387|042|H|1 to 2 minutes before opening your eyes. This will prevent the||
1387|043|H|medication from draining out. Try not to blink or rub your eye.||
1387|044|H|Repeat these steps for your other eye.||
1387|045|H|   Do not rinse the dropper. Replace the dropper cap after each||
1387|046|H|use.||
1387|047|H|   If you are using another kind of eye medication (for example,||
1387|048|H|other drops or ointments), wait at least 5 minutes before||
1387|049|H|applying other medications. Use eye drops before eye ointments to||
1387|050|H|allow the drops to enter the eye.||
1387|051|H|   Wait several minutes for your vision to clear before driving||
1387|052|H|or operating machinery.||
1387|053|H|   Use this medication regularly to get the most benefit from it.||
1387|054|H|To help you remember, use it at the same time each day.||
1387|055|H|   Do not use this product if it becomes contaminated (for||
1387|056|H|example, drops turn a dark color). Using contaminated eye||
1387|057|H|medication can cause infection, serious damage to the eye, and||
1387|058|H|loss of vision. Contact your doctor or pharmacist for more||
1387|059|H|information.||
1387|060|H|   Tell your doctor if your condition does not get better in a||
1387|061|H|few days or if it gets worse.||
1387|062|B|||
1387|063|S|SIDE EFFECTS:  Mild and temporary burning/stinging of the eyes||
1387|064|S|may occur when you apply this medication. If this effect lasts or||
1387|065|S|gets worse, tell your doctor or pharmacist promptly.||
1387|066|S|   If your doctor has prescribed this medication, remember that||
1387|067|S|your doctor has judged that the benefit to you is greater than||
1387|068|S|the risk of side effects. Many people using this medication do||
1387|069|S|not have serious side effects.||
1387|070|S|   A very serious allergic reaction to this drug is rare.||
1387|071|S|However, get medical help right away if you notice any symptoms||
1387|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1387|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1387|074|S|breathing.||
1387|075|S|   This is not a complete list of possible side effects. If you||
1387|076|S|notice other effects not listed above, contact your doctor or||
1387|077|S|pharmacist.||
1387|078|S|   In the US -||
1387|079|S|   Call your doctor for medical advice about side effects. You||
1387|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1387|081|S|www.fda.gov/medwatch.||
1387|082|S|   In Canada - Call your doctor for medical advice about side||
1387|083|S|effects. You may report side effects to Health Canada at||
1387|084|S|1-866-234-2345.||
1387|085|B|||
1387|086|P|PRECAUTIONS:  Before using alcaftadine, tell your doctor or||
1387|087|P|pharmacist if you are allergic to it; or if you have any other||
1387|088|P|allergies. This product may contain inactive ingredients, which||
1387|089|P|can cause allergic reactions or other problems. Talk to your||
1387|090|P|pharmacist for more details.||
1387|091|P|   Before using this medication, tell your doctor or pharmacist||
1387|092|P|your medical history, especially of: contact lens use.||
1387|093|P|   After you apply this drug, your vision may become temporarily||
1387|094|P|blurred. Do not drive, use machinery, or do anything that needs||
1387|095|P|clear vision until you can do it safely.||
1387|096|P|   Before having surgery, tell your doctor or dentist about all||
1387|097|P|the products you use (including prescription drugs,||
1387|098|P|nonprescription drugs, and herbal products).||
1387|099|P|   If you develop an eye infection or eye injury, or require eye||
1387|100|P|surgery, ask your doctor if you should continue to use your||
1387|101|P|current bottle of alcaftadine eye drops or start a new bottle.||
1387|102|P|   During pregnancy, this medication should be used only when||
1387|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
1387|104|P|   It is unknown if this drug passes into breast milk. Consult||
1387|105|P|your doctor before breastfeeding.||
1387|106|B|||
1387|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1387|108|I|medications work or increase your risk for serious side effects.||
1387|109|I|This document does not contain all possible drug interactions.||
1387|110|I|Keep a list of all the products you use (including||
1387|111|I|prescription/nonprescription drugs and herbal products) and share||
1387|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
1387|113|I|the dosage of any medicines without your doctor's approval.||
1387|114|B|||
1387|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1387|116|O|has overdosed and has serious symptoms such as passing out or||
1387|117|O|trouble breathing, call 911. Otherwise, call a poison control||
1387|118|O|center right away. US residents can call 1-800-222-1222. Canada||
1387|119|O|residents can call 1-844-764-7669.||
1387|120|B|||
1387|121|N|NOTES:  Do not share this medication with others.||
1387|122|N|   Ask your doctor about additional ways to reduce your symptoms||
1387|123|N|(such as minimizing your exposure to allergens, using cold||
1387|124|N|compresses and lubricating eye drops).||
1387|125|B|||
1387|126|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1387|127|D|If it is near the time of the next dose, skip the missed dose.||
1387|128|D|Use your next dose at the regular time. Do not double the dose to||
1387|129|D|catch up.||
1387|130|B|||
1387|131|R|STORAGE:  Store at room temperature. Keep all medications away||
1387|132|R|from children and pets.||
1387|133|R|   Do not flush medications down the toilet or pour them into a||
1387|134|R|drain unless instructed to do so. Properly discard this product||
1387|135|R|when it is expired or no longer needed. Consult your pharmacist||
1387|136|R|or local waste disposal company.||
1387|137|B|||
1387|138|A|Information last revised November 2024.||
1387|139|A|Copyright(c) 2025 First Databank, Inc.||
1387|140|B|||
1388|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1388|002|Z|does NOT have all possible information about this product. This||
1388|003|Z|information does not assure that this product is safe, effective,||
1388|004|Z|or appropriate for you. This information is not individual||
1388|005|Z|medical advice and does not substitute for the advice of your||
1388|006|Z|health care professional. Always ask your health care||
1388|007|Z|professional for complete information about this product and your||
1388|008|Z|specific health needs.||
1388|009|B|||
1388|010|T|ACETAMINOPHEN - INJECTION||
1388|011|F|(a-SEET-a-MIN-oh-fen)||
1388|012|B|||
1388|013|C|COMMON BRAND NAME(S): Ofirmev||
1388|014|B|||
1388|015|W|WARNING:  Taking too much acetaminophen may cause serious||
1388|016|W|(possibly fatal) liver disease. Adults should not take more than||
1388|017|W|4000 milligrams (4 grams) of acetaminophen a day. People with||
1388|018|W|liver problems and children should take less acetaminophen. Ask||
1388|019|W|your doctor or pharmacist how much acetaminophen is safe to take.||
1388|020|W|   Do not use with any other drug containing acetaminophen||
1388|021|W|without asking your doctor or pharmacist first. Acetaminophen is||
1388|022|W|in many nonprescription and prescription medications (such as||
1388|023|W|pain/fever drugs or cough-and-cold products). Check the labels on||
1388|024|W|all your medicines to see if they contain acetaminophen, and ask||
1388|025|W|your pharmacist if you are unsure.||
1388|026|W|   Get medical help right away if you take too much acetaminophen||
1388|027|W|(overdose), even if you feel well. Overdose symptoms may include||
1388|028|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
1388|029|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
1388|030|W|   Daily alcohol use, especially when combined with||
1388|031|W|acetaminophen, may damage your liver. Avoid alcohol.||
1388|032|W|   See also How to Use.||
1388|033|B|||
1388|034|U|USES:  This drug is used to treat mild to moderate pain and to||
1388|035|U|reduce fever. It is also used in combination with opioid pain||
1388|036|U|medications to help relieve moderate to severe pain.||
1388|037|B|||
1388|038|H|HOW TO USE:  See also Warning section.||
1388|039|H|   Read the Patient Information Leaflet if available from your||
1388|040|H|pharmacist before you start using acetaminophen and each time you||
1388|041|H|get a refill. If you have any questions, ask your doctor or||
1388|042|H|pharmacist.||
1388|043|H|   This medication is given by injection into a vein as directed||
1388|044|H|by your doctor, usually every 4 to 6 hours as needed for pain||
1388|045|H|relief or to reduce fever. Each dose is usually given over 15||
1388|046|H|minutes.||
1388|047|H|   The dosage is based on your medical condition, age, weight,||
1388|048|H|and response to treatment. For children 12 years of age and||
1388|049|H|younger, and for adults and teenagers weighing less than 110||
1388|050|H|pounds (50 kilograms), the dosage is based on weight and the||
1388|051|H|maximum daily dosage is less than 4000 milligrams of||
1388|052|H|acetaminophen. Consult your doctor or pharmacist for more||
1388|053|H|details.||
1388|054|H|   If you are using this medication at home, learn all||
1388|055|H|preparation and usage instructions from your health care||
1388|056|H|professional. Before using, check this product for particles or||
1388|057|H|discoloration. If either is present, do not use the liquid.||
1388|058|H|   Pain medications work best if they are used as the first signs||
1388|059|H|of pain occur. If you wait until the symptoms have worsened, the||
1388|060|H|medication may not work as well.||
1388|061|H|   Tell your doctor if your condition lasts or gets worse.||
1388|062|B|||
1388|063|S|SIDE EFFECTS:  See also Warning section.||
1388|064|S|   Pain at the injection site may occur. Other side effects are||
1388|065|S|uncommon. If you have any unusual side effects, contact your||
1388|066|S|doctor or pharmacist promptly.||
1388|067|S|   Remember that this medication has been prescribed because your||
1388|068|S|doctor has judged that the benefit to you is greater than the||
1388|069|S|risk of side effects. Many people using this medication do not||
1388|070|S|have serious side effects.||
1388|071|S|   A very serious allergic reaction to this drug is rare.||
1388|072|S|However, get medical help right away if you notice any symptoms||
1388|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1388|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1388|075|S|breathing.||
1388|076|S|   This is not a complete list of possible side effects. If you||
1388|077|S|notice other effects not listed above, contact your doctor or||
1388|078|S|pharmacist.||
1388|079|S|   In the US -||
1388|080|S|   Call your doctor for medical advice about side effects. You||
1388|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1388|082|S|www.fda.gov/medwatch.||
1388|083|S|   In Canada - Call your doctor for medical advice about side||
1388|084|S|effects. You may report side effects to Health Canada at||
1388|085|S|1-866-234-2345.||
1388|086|B|||
1388|087|P|PRECAUTIONS:  See also Warning section.||
1388|088|P|   Before using acetaminophen, tell your doctor or pharmacist if||
1388|089|P|you are allergic to it; or if you have any other allergies. This||
1388|090|P|product may contain inactive ingredients, which can cause||
1388|091|P|allergic reactions or other problems. Talk to your pharmacist for||
1388|092|P|more details.||
1388|093|P|   Before using this product, tell your doctor or pharmacist your||
1388|094|P|medical history, especially of: kidney disease, liver disease,||
1388|095|P|regular use/abuse of alcohol.||
1388|096|P|   Before having surgery, tell your doctor or dentist about all||
1388|097|P|the products you use (including prescription drugs,||
1388|098|P|nonprescription drugs, and herbal products).||
1388|099|P|   During pregnancy, this medication should be used only when||
1388|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
1388|101|P|   It is unknown if this form of acetaminophen passes into breast||
1388|102|P|milk. However, acetaminophen taken by mouth passes into breast||
1388|103|P|milk. Consult your doctor before breastfeeding.||
1388|104|B|||
1388|105|I|DRUG INTERACTIONS:  See also Warning section.||
1388|106|I|   Drug interactions may change how your medications work or||
1388|107|I|increase your risk for serious side effects. This document does||
1388|108|I|not contain all possible drug interactions. Keep a list of all||
1388|109|I|the products you use (including prescription/nonprescription||
1388|110|I|drugs and herbal products) and share it with your doctor and||
1388|111|I|pharmacist. Do not start, stop, or change the dosage of any||
1388|112|I|medicines without your doctor's approval.||
1388|113|I|   Some products that may interact with this drug are:||
1388|114|I|ketoconazole, levoketoconazole.||
1388|115|I|   This medication may interfere with certain lab tests, possibly||
1388|116|I|causing false test results. Make sure lab personnel and all your||
1388|117|I|doctors know you use this drug.||
1388|118|B|||
1388|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1388|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1388|121|O|poison control center right away. US residents can call||
1388|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1388|123|O|Symptoms of overdose may include: nausea, vomiting, loss of||
1388|124|O|appetite, sweating, stomach/abdominal pain, extreme tiredness,||
1388|125|O|yellowing eyes/skin, dark urine.||
1388|126|B|||
1388|127|N|NOTES:  Lab and/or medical tests may be done while you are using||
1388|128|N|this medication. Keep all medical and lab appointments. Consult||
1388|129|N|your doctor for more details.||
1388|130|B|||
1388|131|D|MISSED DOSE:  Not applicable.||
1388|132|B|||
1388|133|R|STORAGE:  If you are using this medication at home, consult the||
1388|134|R|product instructions and your pharmacist for storage details.||
1388|135|R|Keep all medications away from children and pets.||
1388|136|R|   Do not flush medications down the toilet or pour them into a||
1388|137|R|drain unless instructed to do so. Properly discard this product||
1388|138|R|when it is expired or no longer needed. Consult your pharmacist||
1388|139|R|or local waste disposal company.||
1388|140|B|||
1388|141|A|Information last revised November 2024.||
1388|142|A|Copyright(c) 2025 First Databank, Inc.||
1388|143|B|||
1389|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1389|002|Z|does NOT have all possible information about this product. This||
1389|003|Z|information does not assure that this product is safe, effective,||
1389|004|Z|or appropriate for you. This information is not individual||
1389|005|Z|medical advice and does not substitute for the advice of your||
1389|006|Z|health care professional. Always ask your health care||
1389|007|Z|professional for complete information about this product and your||
1389|008|Z|specific health needs.||
1389|009|B|||
1389|010|T|SPINOSAD SUSPENSION - TOPICAL||
1389|011|F|(SPIN-oh-sad)||
1389|012|B|||
1389|013|C|COMMON BRAND NAME(S): Natroba||
1389|014|B|||
1389|015|U|USES:  This medication is used to treat head lice, tiny insects||
1389|016|U|that infest and irritate your scalp. Head lice lay small white||
1389|017|U|eggs (nits) at the roots of hair close to the scalp, especially||
1389|018|U|on the hairline at the back of the neck and behind the ears. This||
1389|019|U|medication is also used to treat scabies. Scabies is caused by||
1389|020|U|tiny insects called mites that infest and irritate your skin.||
1389|021|U|Spinosad works by paralyzing and killing lice/mites and their||
1389|022|U|eggs.||
1389|023|U|   This medication should not be used on infants younger than 6||
1389|024|U|months due to the increased risk for serious side effects.||
1389|025|B|||
1389|026|H|HOW TO USE:  Read the Patient Information Leaflet and Patient||
1389|027|H|Instructions for Use if available from your pharmacist before you||
1389|028|H|start using spinosad and each time you get a refill. If you have||
1389|029|H|any questions, ask your doctor or pharmacist.||
1389|030|H|   This medication is for external use only. Shake the bottle||
1389|031|H|well just before using.||
1389|032|H|   For lice treatment: Apply this medication to scalp hair and||
1389|033|H|scalp only. Use this medication when your hair is dry. Do not wet||
1389|034|H|your hair before applying. Cover your face and eyes with a towel||
1389|035|H|and keep your eyes closed tightly while applying this medication||
1389|036|H|and during the time it remains on your scalp and hair. Avoid||
1389|037|H|getting spinosad in your eyes. If the medication gets in or near||
1389|038|H|the eye, flush with plenty of water right away. Since you should||
1389|039|H|keep your eyes closed during application, you may need to have||
1389|040|H|another person help you apply this medication. Children will need||
1389|041|H|an adult to apply this medication for them.||
1389|042|H|   Completely cover the scalp with spinosad first, and then apply||
1389|043|H|outward toward the ends of the hair. If you do not use enough||
1389|044|H|spinosad, some lice may escape treatment. It is important to use||
1389|045|H|enough medication to cover your entire scalp and scalp hair.||
1389|046|H|Leave the medication on your hair for 10 minutes. Use a timer or||
1389|047|H|clock and start timing after you have completely covered your||
1389|048|H|hair and scalp with medication. After 10 minutes, rinse||
1389|049|H|thoroughly with warm water. You or anyone who helps you apply||
1389|050|H|this medication should wash hands after application. You may||
1389|051|H|shampoo your hair any time after treatment.||
1389|052|H|   After treatment with this medication, you may use a fine-tooth||
1389|053|H|comb or a special comb for removing treated lice and nits.||
1389|054|H|However, combing is not required. If you see live lice 7 days or||
1389|055|H|more after treatment, a second treatment should be given. Do not||
1389|056|H|repeat treatment more than once unless otherwise directed by your||
1389|057|H|doctor.||
1389|058|H|   To avoid giving lice to another person or getting them again,||
1389|059|H|wash all head wear, clothing, bed linens, and towels with hot||
1389|060|H|water, then dry in a dryer at high setting for at least 20||
1389|061|H|minutes. Personal articles such as pillows or stuffed animals||
1389|062|H|that cannot be washed should be dry cleaned, sealed in a plastic||
1389|063|H|bag for at least 2 weeks, or sprayed with a disinfectant that||
1389|064|H|kills lice. Brushes or combs should be soaked in hot water for at||
1389|065|H|least 10 minutes. Furniture and floors should be thoroughly||
1389|066|H|vacuumed.||
1389|067|H|   For scabies treatment: Apply enough to completely cover your||
1389|068|H|body from your neck to the soles of your feet. Make sure you||
1389|069|H|apply to folds of skin, between fingers and toes, and under your||
1389|070|H|finger and toe nails. If you are balding, also apply to the||
1389|071|H|scalp, hairline, temples, and forehead. If you accidentally get||
1389|072|H|this medication in your eyes, flush with plenty of water right||
1389|073|H|away. Children will need an adult to apply this medication for||
1389|074|H|them. Wash your hands after applying this medication to someone||
1389|075|H|else. Allow this medication to soak into skin and dry for a full||
1389|076|H|10 minutes before getting dressed. Use a timer or clock and start||
1389|077|H|timing after you have completely covered your body with spinosad.||
1389|078|H|Wait at least 6 hours before showering or bathing.||
1389|079|H|   To help prevent spread of scabies from one person to another,||
1389|080|H|get household members checked by their health care professional.||
1389|081|H|Avoid direct body-to-body contact with anyone who has scabies. Do||
1389|082|H|not share clothing, towels, bedding, or linens with anyone else.||
1389|083|H|Wash any bedding, clothing, and towels that you have used any||
1389|084|H|time during the 3 days before treatment by washing in hot water||
1389|085|H|and drying in a hot dryer, or by sealing in a plastic bag for at||
1389|086|H|least 72 hours.||
1389|087|H|   Tell your doctor if your condition lasts or gets worse.||
1389|088|B|||
1389|089|S|SIDE EFFECTS:  Skin or eye irritation/redness may occur. If any||
1389|090|S|of these effects last or get worse, tell your doctor or||
1389|091|S|pharmacist promptly.||
1389|092|S|   Remember that this medication has been prescribed because your||
1389|093|S|doctor has judged that the benefit to you is greater than the||
1389|094|S|risk of side effects. Many people using this medication do not||
1389|095|S|have serious side effects.||
1389|096|S|   A very serious allergic reaction to this drug is rare.||
1389|097|S|However, get medical help right away if you notice any symptoms||
1389|098|S|of a serious allergic reaction, including: rash, itching/swelling||
1389|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1389|100|S|breathing.||
1389|101|S|   This is not a complete list of possible side effects. If you||
1389|102|S|notice other effects not listed above, contact your doctor or||
1389|103|S|pharmacist.||
1389|104|S|   In the US -||
1389|105|S|   Call your doctor for medical advice about side effects. You||
1389|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1389|107|S|www.fda.gov/medwatch.||
1389|108|S|   In Canada - Call your doctor for medical advice about side||
1389|109|S|effects. You may report side effects to Health Canada at||
1389|110|S|1-866-234-2345.||
1389|111|B|||
1389|112|P|PRECAUTIONS:  Before using spinosad, tell your doctor or||
1389|113|P|pharmacist if you are allergic to it; or if you have any other||
1389|114|P|allergies. This product may contain inactive ingredients, which||
1389|115|P|can cause allergic reactions or other problems. Talk to your||
1389|116|P|pharmacist for more details.||
1389|117|P|   Before using this medication, tell your doctor or pharmacist||
1389|118|P|your medical history, especially of: skin conditions or||
1389|119|P|sensitivities.||
1389|120|P|   Constant or forceful scratching of the skin/scalp may lead to||
1389|121|P|a bacterial skin infection. Tell your doctor right away if you||
1389|122|P|develop worsening redness or pus.||
1389|123|P|   Before having surgery, tell your doctor or dentist about all||
1389|124|P|the products you use (including prescription drugs,||
1389|125|P|nonprescription drugs, and herbal products).||
1389|126|P|   Tell your doctor if you are pregnant before using this||
1389|127|P|medication.||
1389|128|P|   Spinosad does not pass into breast milk. However, it is||
1389|129|P|unknown if an inactive ingredient in this medication, benzyl||
1389|130|P|alcohol, may pass into breast milk and harm a nursing infant.||
1389|131|P|Consult your doctor before breastfeeding.||
1389|132|B|||
1389|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1389|134|I|medications work or increase your risk for serious side effects.||
1389|135|I|This document does not contain all possible drug interactions.||
1389|136|I|Keep a list of all the products you use (including||
1389|137|I|prescription/nonprescription drugs and herbal products) and share||
1389|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
1389|139|I|the dosage of any medicines without your doctor's approval.||
1389|140|B|||
1389|141|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1389|142|O|has overdosed and has serious symptoms such as passing out or||
1389|143|O|trouble breathing, call 911. Otherwise, call a poison control||
1389|144|O|center right away. US residents can call 1-800-222-1222. Canada||
1389|145|O|residents can call 1-844-764-7669.||
1389|146|B|||
1389|147|N|NOTES:  Do not share this medication with another person unless||
1389|148|N|directed to do so by your doctor.||
1389|149|N|   People who are in close contact with the infected person, such||
1389|150|N|as members of the same household, should also be checked. Be sure||
1389|151|N|to talk with your doctor about treatment for close contacts.||
1389|152|B|||
1389|153|D|MISSED DOSE:  Not applicable.||
1389|154|B|||
1389|155|R|STORAGE:  Store at room temperature. Keep all medications away||
1389|156|R|from children and pets.||
1389|157|R|   Do not flush medications down the toilet or pour them into a||
1389|158|R|drain unless instructed to do so. Properly discard this product||
1389|159|R|when it is expired or no longer needed. Consult your pharmacist||
1389|160|R|or local waste disposal company.||
1389|161|B|||
1389|162|A|Information last revised May 2024.||
1389|163|A|Copyright(c) 2025 First Databank, Inc.||
1389|164|B|||
1390|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1390|002|Z|does NOT have all possible information about this product. This||
1390|003|Z|information does not assure that this product is safe, effective,||
1390|004|Z|or appropriate for you. This information is not individual||
1390|005|Z|medical advice and does not substitute for the advice of your||
1390|006|Z|health care professional. Always ask your health care||
1390|007|Z|professional for complete information about this product and your||
1390|008|Z|specific health needs.||
1390|009|B|||
1390|010|T|LEVALBUTEROL CONCENTRATED SOLUTION - INHALATION||
1390|011|F|(LEV-al-BUE-ter-ol)||
1390|012|B|||
1390|013|C|COMMON BRAND NAME(S): Xopenex||
1390|014|B|||
1390|015|U|USES:  Levalbuterol is used to prevent and treat wheezing and||
1390|016|U|shortness of breath caused by breathing problems (such as asthma,||
1390|017|U|chronic obstructive pulmonary disease). It is a quick-relief||
1390|018|U|drug. Levalbuterol belongs to a class of drugs known as||
1390|019|U|bronchodilators. It works by relaxing the muscles around the||
1390|020|U|airways so that they open up and you can breathe more easily.||
1390|021|U|Controlling symptoms of breathing problems can decrease time lost||
1390|022|U|from work or school.||
1390|023|B|||
1390|024|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1390|025|H|your pharmacist before you start using this medication and each||
1390|026|H|time you get a refill. This medication is used with a special||
1390|027|H|machine called a nebulizer that changes the solution to a fine||
1390|028|H|mist that you inhale. Learn how to prepare the solution and use||
1390|029|H|the nebulizer properly. If a child is using this medication, a||
1390|030|H|parent or other responsible adult may need to help the child use||
1390|031|H|the nebulizer properly. If you have any questions, ask your||
1390|032|H|doctor, pharmacist, or respiratory therapist.||
1390|033|H|   This product should be clear and colorless. Before using,||
1390|034|H|check this product for particles or discoloration. If either is||
1390|035|H|present, do not use the liquid.||
1390|036|H|   Using the nebulizer, inhale this medication into your lungs as||
1390|037|H|directed by your doctor, usually 3 times a day. Each treatment||
1390|038|H|usually takes about 5 to 15 minutes. Use this medication only||
1390|039|H|through a nebulizer. Do not swallow or inject the solution. Do||
1390|040|H|not mix with other medicines in the nebulizer. To prevent||
1390|041|H|infections, clean the nebulizer and mouthpiece/face mask||
1390|042|H|according to the manufacturer's directions.||
1390|043|H|   Use this medication regularly to get the most benefit from it.||
1390|044|H|To help you remember, use it at the same times each day.||
1390|045|H|   The dosage is based on your medical condition, age, and||
1390|046|H|response to treatment. Do not increase your dose or use this drug||
1390|047|H|more often than prescribed without your doctor's approval. Using||
1390|048|H|too much of this medication will increase your risk of serious||
1390|049|H|(possibly fatal) side effects.||
1390|050|H|   Learn which of your inhalers/medications you should use every||
1390|051|H|day (controller drugs) and which you should use if your breathing||
1390|052|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
1390|053|H|time what you should do if you have new or worsening cough or||
1390|054|H|shortness of breath, wheezing, increased sputum, worsening peak||
1390|055|H|flow meter readings, waking up at night with trouble breathing,||
1390|056|H|if you use your quick-relief inhaler/medication more often (more||
1390|057|H|than 2 days a week), or if your quick-relief inhaler/medication||
1390|058|H|does not seem to be working well. Learn when you can treat sudden||
1390|059|H|breathing problems by yourself and when you must get medical help||
1390|060|H|right away.||
1390|061|H|   Tell your doctor if your symptoms do not get better or if they||
1390|062|H|get worse.||
1390|063|B|||
1390|064|S|SIDE EFFECTS:  Nervousness, dizziness, shaking (tremor), trouble||
1390|065|S|sleeping, headache, nausea, dry mouth, increased coughing, or||
1390|066|S|runny nose may occur. If any of these effects last or get worse,||
1390|067|S|tell your doctor or pharmacist promptly.||
1390|068|S|   Remember that this medication has been prescribed because your||
1390|069|S|doctor has judged that the benefit to you is greater than the||
1390|070|S|risk of side effects. Many people using this medication do not||
1390|071|S|have serious side effects.||
1390|072|S|   This medication may raise your blood pressure. Check your||
1390|073|S|blood pressure regularly and tell your doctor if the results are||
1390|074|S|high.||
1390|075|S|   Tell your doctor right away if you have any serious side||
1390|076|S|effects, including: fast/pounding heartbeat.||
1390|077|S|   Get medical help right away if you have any very serious side||
1390|078|S|effects, including: chest pain, irregular heartbeat, rapid||
1390|079|S|breathing, confusion.||
1390|080|S|   Rarely, this medication has caused severe (rarely fatal),||
1390|081|S|sudden worsening of breathing problems/asthma (paradoxical||
1390|082|S|bronchospasm). If you experience sudden wheezing, get medical||
1390|083|S|help right away.||
1390|084|S|   A very serious allergic reaction to this drug is rare.||
1390|085|S|However, get medical help right away if you notice any symptoms||
1390|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1390|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1390|088|S|breathing.||
1390|089|S|   This is not a complete list of possible side effects. If you||
1390|090|S|notice other effects not listed above, contact your doctor or||
1390|091|S|pharmacist.||
1390|092|S|   In the US -||
1390|093|S|   Call your doctor for medical advice about side effects. You||
1390|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1390|095|S|www.fda.gov/medwatch.||
1390|096|S|   In Canada - Call your doctor for medical advice about side||
1390|097|S|effects. You may report side effects to Health Canada at||
1390|098|S|1-866-234-2345.||
1390|099|B|||
1390|100|P|PRECAUTIONS:  Before taking levalbuterol, tell your doctor or||
1390|101|P|pharmacist if you are allergic to it; or to similar drugs (such||
1390|102|P|as albuterol, metaproterenol, salmeterol); or if you have any||
1390|103|P|other allergies. This product may contain inactive ingredients,||
1390|104|P|which can cause allergic reactions or other problems. Talk to||
1390|105|P|your pharmacist for more details.||
1390|106|P|   Before using this medication, tell your doctor or pharmacist||
1390|107|P|your medical history, especially of: diabetes, heart problems||
1390|108|P|(such as irregular heartbeat, angina, previous heart attack),||
1390|109|P|high blood pressure, kidney disease, seizure.||
1390|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1390|111|P|can make you more dizzy. Do not drive, use machinery, or do||
1390|112|P|anything that needs alertness until you can do it safely. Limit||
1390|113|P|alcoholic beverages. Talk to your doctor if you are using||
1390|114|P|marijuana (cannabis).||
1390|115|P|   Before having surgery, tell your doctor or dentist about all||
1390|116|P|the products you use (including prescription drugs,||
1390|117|P|nonprescription drugs, and herbal products).||
1390|118|P|   During pregnancy, this medication should be used only when||
1390|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
1390|120|P|   It is unknown if this drug passes into breast milk. Consult||
1390|121|P|your doctor before breastfeeding.||
1390|122|B|||
1390|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1390|124|I|medications work or increase your risk for serious side effects.||
1390|125|I|This document does not contain all possible drug interactions.||
1390|126|I|Keep a list of all the products you use (including||
1390|127|I|prescription/nonprescription drugs and herbal products) and share||
1390|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
1390|129|I|the dosage of any medicines without your doctor's approval.||
1390|130|I|   Levalbuterol is very similar to albuterol. Do not use inhaled||
1390|131|I|medications containing albuterol while using levalbuterol.||
1390|132|B|||
1390|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1390|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1390|135|O|poison control center right away. US residents can call||
1390|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1390|137|O|Symptoms of overdose may include: chest pain,||
1390|138|O|fast/pounding/irregular heartbeat, headache, shaking (tremors),||
1390|139|O|nervousness, weakness, severe dizziness, seizures.||
1390|140|B|||
1390|141|N|NOTES:  Do not share this medication with others.||
1390|142|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
1390|143|N|EKG) may be done while you are using this medication. Keep all||
1390|144|N|medical and lab appointments. Consult your doctor for more||
1390|145|N|details.||
1390|146|N|   Avoid allergens/irritants that can worsen breathing problems,||
1390|147|N|such as smoke, pollen, pet dander, dust, or molds.||
1390|148|N|   Learn to use a peak flow meter, use it daily, and promptly||
1390|149|N|report worsening breathing problems (such as readings in the||
1390|150|N|yellow/red range, increased use of quick-relief inhalers).||
1390|151|N|   Because the flu virus can worsen breathing problems, ask your||
1390|152|N|doctor or pharmacist if you should have a flu shot every year.||
1390|153|B|||
1390|154|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1390|155|D|If it is near the time of the next dose, skip the missed dose.||
1390|156|D|Use your next dose at the regular time. Do not double the dose to||
1390|157|D|catch up.||
1390|158|B|||
1390|159|R|STORAGE:  Store vials in the foil pouch at room temperature away||
1390|160|R|from light and heat. Do not open the foil pouch until you are||
1390|161|R|ready to use the medication. Keep all medications away from||
1390|162|R|children and pets.||
1390|163|R|   Do not flush medications down the toilet or pour them into a||
1390|164|R|drain unless instructed to do so. Properly discard this product||
1390|165|R|when it is expired or no longer needed. Consult your pharmacist||
1390|166|R|or local waste disposal company.||
1390|167|B|||
1390|168|M|MEDICAL ALERT:  Your condition can cause complications in a||
1390|169|M|medical emergency. For information about enrolling in MedicAlert,||
1390|170|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1390|171|B|||
1390|172|A|Information last revised November 2024.||
1390|173|A|Copyright(c) 2025 First Databank, Inc.||
1390|174|B|||
1391|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1391|002|Z|does NOT have all possible information about this product. This||
1391|003|Z|information does not assure that this product is safe, effective,||
1391|004|Z|or appropriate for you. This information is not individual||
1391|005|Z|medical advice and does not substitute for the advice of your||
1391|006|Z|health care professional. Always ask your health care||
1391|007|Z|professional for complete information about this product and your||
1391|008|Z|specific health needs.||
1391|009|B|||
1391|010|T|NON-OPIOID ANTITUSSIVE/ANTIHISTAMINE - ORAL||
1391|011|B|||
1391|012|U|USES:  This combination product is used for the temporary relief||
1391|013|U|of cough, sneezing, or runny nose due to the common cold, hay||
1391|014|U|fever or other upper respiratory allergies. This product contains||
1391|015|U|a non-opioid cough suppressant (such as chlophedianol,||
1391|016|U|dextromethorphan). It affects a certain part of the brain (cough||
1391|017|U|center) to help you stop coughing. This product also contains an||
1391|018|U|antihistamine (such as triprolidine, chlorpheniramine,||
1391|019|U|doxylamine) that works by blocking the effects of a certain||
1391|020|U|natural substance (histamine), which causes allergy symptoms. It||
1391|021|U|also has a drying effect. Talk with your doctor before using this||
1391|022|U|product for a chronic cough from smoking or a cough with too||
1391|023|U|much/thick mucus.||
1391|024|U|   Cough-and-cold products have not been shown to be safe or||
1391|025|U|effective in children younger than 6 years. Do not use this||
1391|026|U|product to treat cold symptoms in children younger than 6 years||
1391|027|U|unless specifically directed by the doctor. Some products (such||
1391|028|U|as long-acting tablets/capsules) are not recommended for use in||
1391|029|U|children younger than 12 years. Ask your doctor or pharmacist for||
1391|030|U|more details about using your product safely.||
1391|031|U|   These products do not cure or shorten the length of the common||
1391|032|U|cold and may cause serious side effects. To decrease the risk for||
1391|033|U|serious side effects, carefully follow all dosage directions. Do||
1391|034|U|not use this product to make a child sleepy. Do not give other||
1391|035|U|cough-and-cold medication that might contain the same or similar||
1391|036|U|ingredients (see also Drug Interactions section). Ask the doctor||
1391|037|U|or pharmacist about other ways to relieve cough and cold symptoms||
1391|038|U|(such as drinking enough fluids, using a humidifier or saline||
1391|039|U|nose drops/spray).||
1391|040|U|   Check the ingredients on the label even if you have used the||
1391|041|U|product before. The manufacturer may have changed the||
1391|042|U|ingredients. Also, products with similar brand names may contain||
1391|043|U|different ingredients meant for different purposes. Taking the||
1391|044|U|wrong product could harm you.||
1391|045|B|||
1391|046|H|HOW TO USE:  If you are taking the over-the-counter product to||
1391|047|H|self-treat, follow all directions on the product package before||
1391|048|H|taking this medication. If you have any questions, ask your||
1391|049|H|doctor or pharmacist. If your doctor has prescribed this||
1391|050|H|medication, take it as directed.||
1391|051|H|   Take the tablet, capsule, or liquid form by mouth with or||
1391|052|H|without food. This medication may be taken with food or milk if||
1391|053|H|stomach upset occurs.||
1391|054|H|   The dosage is based on your age, medical condition, and||
1391|055|H|response to treatment. Do not increase your dose or take this||
1391|056|H|drug more often than directed. Do not take more of this||
1391|057|H|medication than recommended for your age. There are many brands||
1391|058|H|and forms of this product available. Read the dosing instructions||
1391|059|H|carefully for each product because the amount of cough||
1391|060|H|suppressant and antihistamine may be different between products.||
1391|061|H|   If you are using the chewable tablets, chew each tablet well||
1391|062|H|and swallow. If you are using the liquid form of this medication,||
1391|063|H|measure the dose carefully using a special measuring device/cup.||
1391|064|H|Do not use a household spoon because you may not get the correct||
1391|065|H|dose.||
1391|066|H|   If you are using a product made to dissolve in the mouth (such||
1391|067|H|as strips), dry your hands before handling the medication. Place||
1391|068|H|each dose on the tongue and allow to dissolve completely, then||
1391|069|H|swallow it with saliva or with water.||
1391|070|H|   Tell your doctor if your symptoms do not get better after 7||
1391|071|H|days or if they get worse or return, or if you have a headache||
1391|072|H|that doesn't go away, fever, or rash. If you think you may have a||
1391|073|H|serious medical problem, get medical help right away.||
1391|074|B|||
1391|075|S|SIDE EFFECTS:  Drowsiness, dizziness, blurred vision, nausea,||
1391|076|S|vomiting, trouble sleeping, or headache may occur. If any of||
1391|077|S|these effects last or get worse, tell your doctor or pharmacist||
1391|078|S|promptly.||
1391|079|S|   If your doctor has directed you to use this medication,||
1391|080|S|remember that your doctor has judged that the benefit to you is||
1391|081|S|greater than the risk of side effects. Many people using this||
1391|082|S|medication do not have serious side effects.||
1391|083|S|   Tell your doctor right away if you have any serious side||
1391|084|S|effects, including: fast/irregular/pounding heartbeat,||
1391|085|S|mental/mood changes (such as confusion, hallucinations,||
1391|086|S|nervousness), seizures, shaking (tremors), trouble urinating.||
1391|087|S|   A very serious allergic reaction to this drug is rare.||
1391|088|S|However, get medical help right away if you notice any symptoms||
1391|089|S|of a serious allergic reaction, including: rash, itching/swelling||
1391|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1391|091|S|breathing.||
1391|092|S|   This is not a complete list of possible side effects. If you||
1391|093|S|notice other effects not listed above, contact your doctor or||
1391|094|S|pharmacist.||
1391|095|S|   In the US -||
1391|096|S|   Call your doctor for medical advice about side effects. You||
1391|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1391|098|S|www.fda.gov/medwatch.||
1391|099|S|   In Canada - Call your doctor for medical advice about side||
1391|100|S|effects. You may report side effects to Health Canada at||
1391|101|S|1-866-234-2345.||
1391|102|B|||
1391|103|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1391|104|P|pharmacist if you are allergic to it; or if you have any other||
1391|105|P|allergies. This product may contain inactive ingredients, which||
1391|106|P|can cause allergic reactions or other problems. Talk to your||
1391|107|P|pharmacist for more details.||
1391|108|P|   If you have any of the following health problems, consult your||
1391|109|P|doctor or pharmacist before using this product: cough with a lot||
1391|110|P|of mucus, chronic cough (such as with asthma, emphysema,||
1391|111|P|smoking), a certain eye condition (glaucoma), difficulty||
1391|112|P|urinating (such as due to enlarged prostate).||
1391|113|P|   This drug may make you dizzy or drowsy or blur your vision.||
1391|114|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1391|115|P|drowsy. Do not drive, use machinery, or do anything that needs||
1391|116|P|alertness or clear vision until you can do it safely. Limit||
1391|117|P|alcoholic beverages. Talk to your doctor if you are using||
1391|118|P|marijuana (cannabis).||
1391|119|P|   Liquid products, chewable tablets, or dissolving||
1391|120|P|tablets/strips may contain sugar, alcohol, or aspartame. Caution||
1391|121|P|is advised if you have diabetes, alcohol dependence, liver||
1391|122|P|disease, phenylketonuria (PKU), or any other condition that||
1391|123|P|requires you to limit/avoid these substances in your diet. Ask||
1391|124|P|your doctor or pharmacist about using this product safely.||
1391|125|P|   Some brands of this medication contain sodium. Ask your doctor||
1391|126|P|or pharmacist for more information if you are on a||
1391|127|P|salt-restricted diet or if you have a condition that could be||
1391|128|P|worsened by an increase in salt intake.||
1391|129|P|   Before having surgery, tell your doctor or dentist about all||
1391|130|P|the products you use (including prescription drugs,||
1391|131|P|nonprescription drugs, and herbal products).||
1391|132|P|   Older adults may be more sensitive to the side effects of this||
1391|133|P|medication, especially drowsiness, dizziness, confusion, and||
1391|134|P|problems urinating.||
1391|135|P|   Children may also be more sensitive to the side effects of||
1391|136|P|antihistamines. In young children, antihistamines may cause||
1391|137|P|agitation/excitement instead of drowsiness.||
1391|138|P|   During pregnancy, this medication should be used only when||
1391|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
1391|140|P|   This product may pass into breast milk and could have||
1391|141|P|undesirable effects on a nursing infant. Consult your doctor||
1391|142|P|before breastfeeding.||
1391|143|B|||
1391|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1391|145|I|medications work or increase your risk for serious side effects.||
1391|146|I|This document does not contain all possible drug interactions.||
1391|147|I|Keep a list of all the products you use (including||
1391|148|I|prescription/nonprescription drugs and herbal products) and share||
1391|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
1391|150|I|the dosage of any medicines without your doctor's approval.||
1391|151|I|   Taking certain MAO inhibitors with this medication may cause a||
1391|152|I|serious (possibly fatal) drug interaction. Avoid taking||
1391|153|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
1391|154|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
1391|155|I|tranylcypromine during treatment with this medication. Most MAO||
1391|156|I|inhibitors should also not be taken for two weeks before||
1391|157|I|treatment with this medication. Ask your doctor when to start or||
1391|158|I|stop taking this medication.||
1391|159|I|   Tell your doctor or pharmacist if you are taking other||
1391|160|I|products that cause drowsiness such as opioid pain or cough||
1391|161|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1391|162|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1391|163|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1391|164|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1391|165|I|diphenhydramine).||
1391|166|I|   Check the labels on all your medicines (such as allergy or||
1391|167|I|cough-and-cold products) because they may contain similar||
1391|168|I|ingredients (other antihistamines or cough suppressants) or||
1391|169|I|contain ingredients that cause drowsiness. Ask your pharmacist||
1391|170|I|about using those products safely.||
1391|171|I|   This medication may interfere with certain lab tests (such as||
1391|172|I|urine drug screening tests, allergy skin test), possibly causing||
1391|173|I|false test results. Make sure lab personnel and all your doctors||
1391|174|I|know you use this drug.||
1391|175|B|||
1391|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1391|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1391|178|O|poison control center right away. US residents can call||
1391|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1391|180|O|Symptoms of overdose may include: severe drowsiness, agitation,||
1391|181|O|confusion, hallucinations, seizures.||
1391|182|B|||
1391|183|N|NOTES:  If your doctor has prescribed this medication for you, do||
1391|184|N|not share it with others.||
1391|185|N|   This medication is for temporary use only. Do not use for more||
1391|186|N|than 7 days without first consulting your doctor.||
1391|187|B|||
1391|188|D|MISSED DOSE:  If you are taking this product on a regular||
1391|189|D|schedule and miss a dose, take it as soon as you remember. If it||
1391|190|D|is near the time of the next dose, skip the missed dose. Take||
1391|191|D|your next dose at the regular time. Do not double the dose to||
1391|192|D|catch up.||
1391|193|B|||
1391|194|R|STORAGE:  Different brands of this medication have different||
1391|195|R|storage needs. Check the product package for instructions on how||
1391|196|R|to store your brand, or ask your pharmacist. Keep all medications||
1391|197|R|away from children and pets.||
1391|198|R|   Do not flush medications down the toilet or pour them into a||
1391|199|R|drain unless instructed to do so. Properly discard this product||
1391|200|R|when it is expired or no longer needed. Consult your pharmacist||
1391|201|R|or local waste disposal company.||
1391|202|B|||
1391|203|A|Information last revised November 2024.||
1391|204|A|Copyright(c) 2025 First Databank, Inc.||
1391|205|B|||
1392|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1392|002|Z|does NOT have all possible information about this product. This||
1392|003|Z|information does not assure that this product is safe, effective,||
1392|004|Z|or appropriate for you. This information is not individual||
1392|005|Z|medical advice and does not substitute for the advice of your||
1392|006|Z|health care professional. Always ask your health care||
1392|007|Z|professional for complete information about this product and your||
1392|008|Z|specific health needs.||
1392|009|B|||
1392|010|T|IPILIMUMAB - INJECTION||
1392|011|F|(IP-i-LIM-ue-mab)||
1392|012|B|||
1392|013|C|COMMON BRAND NAME(S): Yervoy||
1392|014|B|||
1392|015|U|USES:  Ipilimumab is used to treat various cancers. Ipilimumab||
1392|016|U|belongs to a class of drugs known as monoclonal antibodies. It||
1392|017|U|works by slowing or stopping the growth of cancer cells. However,||
1392|018|U|it can have serious side effects in other parts of your body (see||
1392|019|U|also Side Effects section).||
1392|020|B|||
1392|021|H|HOW TO USE:  Read the Medication Guide and Patient Wallet Card||
1392|022|H|provided by your pharmacist before you start using ipilimumab and||
1392|023|H|before each treatment with this medication. If you have any||
1392|024|H|questions, ask your doctor or pharmacist. Carry the Patient||
1392|025|H|Wallet Card with you at all times. Show the card to all of your||
1392|026|H|health care providers to let them know that you are being treated||
1392|027|H|with ipilimumab.||
1392|028|H|   This medication is given by injection into a vein as directed||
1392|029|H|by your doctor, usually by slow injection over 30 minutes. The||
1392|030|H|injection is given by a health care professional. The dosage and||
1392|031|H|treatment schedule are based on your medical condition, weight,||
1392|032|H|and response to treatment.||
1392|033|H|   To decrease the risk of side effects, your doctor may||
1392|034|H|prescribe other medications to take along with this medication.||
1392|035|H|Carefully follow your doctor's directions for all your||
1392|036|H|medications.||
1392|037|H|   Infusion reactions may happen during the infusion of this||
1392|038|H|drug. Tell your doctor right away if you have symptoms of||
1392|039|H|infusion reaction such as shortness of breath, feeling faint,||
1392|040|H|dizziness, or fever.||
1392|041|H|   Use this medication regularly to get the most benefit from it.||
1392|042|H|To help you remember, mark your calendar with a reminder.||
1392|043|B|||
1392|044|S|SIDE EFFECTS:  See also How To Use section.||
1392|045|S|   Tiredness, nausea, or vomiting may occur. If any of these||
1392|046|S|effects last or get worse, tell your doctor or pharmacist||
1392|047|S|promptly.||
1392|048|S|   People using this medication may have serious side effects.||
1392|049|S|However, you have been prescribed this drug because your doctor||
1392|050|S|has judged that the benefit to you is greater than the risk of||
1392|051|S|side effects. Careful monitoring by your doctor may decrease your||
1392|052|S|risk.||
1392|053|S|   This medication can cause serious (sometimes fatal) side||
1392|054|S|effects in many parts of the body. These effects can occur during||
1392|055|S|treatment with ipilimumab, but can also occur months after the||
1392|056|S|last dose of this medication. Get medical help right away if you||
1392|057|S|have any very serious side effects, including: headache that||
1392|058|S|doesn't go away, signs of intestinal problems (such as diarrhea,||
1392|059|S|mucus or blood in your stool, stomach pain), signs of liver||
1392|060|S|disease (such as yellowing of skin/eyes, dark urine), unusual||
1392|061|S|bleeding/bruising, unusual weakness, mouth sores,||
1392|062|S|numbness/tingling in hands/feet, signs of thyroid problems (such||
1392|063|S|as feeling cold all the time, heat intolerance, weight gain/loss,||
1392|064|S|fast/pounding/irregular heartbeat), mental /mood changes, change||
1392|065|S|in sex drive, signs of kidney problems (such as change in the||
1392|066|S|amount of urine), increased thirst/urination, dizziness,||
1392|067|S|fainting, eye pain/redness, vision changes (such as blurred||
1392|068|S|vision, double vision, decreased vision, blindness), signs of||
1392|069|S|lung problems (such as chest pain, shortness of breath,||
1392|070|S|new/worsening cough), seizure, muscle pain, hearing loss, night||
1392|071|S|sweats.||
1392|072|S|   A very serious allergic reaction to this drug is rare.||
1392|073|S|However, get medical help right away if you notice any symptoms||
1392|074|S|of a serious allergic reaction, including: fever, swollen lymph||
1392|075|S|nodes, rash, itching/swelling (especially of the||
1392|076|S|face/tongue/throat), severe dizziness, trouble breathing.||
1392|077|S|   This is not a complete list of possible side effects. If you||
1392|078|S|notice other effects not listed above, contact your doctor or||
1392|079|S|pharmacist.||
1392|080|S|   In the US -||
1392|081|S|   Call your doctor for medical advice about side effects. You||
1392|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1392|083|S|www.fda.gov/medwatch.||
1392|084|S|   In Canada - Call your doctor for medical advice about side||
1392|085|S|effects. You may report side effects to Health Canada at||
1392|086|S|1-866-234-2345.||
1392|087|B|||
1392|088|P|PRECAUTIONS:  Before using ipilimumab, tell your doctor or||
1392|089|P|pharmacist if you are allergic to it; or if you have any other||
1392|090|P|allergies. This product may contain inactive ingredients, which||
1392|091|P|can cause allergic reactions or other problems. Talk to your||
1392|092|P|pharmacist for more details.||
1392|093|P|   Before using this medication, tell your doctor or pharmacist||
1392|094|P|your medical history, especially of: organ transplant, stem cell||
1392|095|P|transplant with donor cells, immune system disorders (such as||
1392|096|P|Guillain-Barre syndrome, lupus, sarcoidosis, Crohn's disease,||
1392|097|P|ulcerative colitis).||
1392|098|P|   Before having surgery, tell your doctor or dentist about all||
1392|099|P|the products you use (including prescription drugs,||
1392|100|P|nonprescription drugs, and herbal products).||
1392|101|P|   Tell your doctor if you are pregnant or plan to become||
1392|102|P|pregnant. You should not become pregnant while using ipilimumab.||
1392|103|P|Ipilimumab may harm an unborn baby. Your doctor should order a||
1392|104|P|pregnancy test before you start this medication. Ask about||
1392|105|P|reliable forms of birth control while using this medication and||
1392|106|P|for 3 months after the last dose. If you become pregnant, talk to||
1392|107|P|your doctor right away about the risks and benefits of this||
1392|108|P|medication.||
1392|109|P|   This medication passes into breast milk. Because of the||
1392|110|P|possible risk to the infant, breastfeeding is not recommended||
1392|111|P|while using this medication and for 3 months after the last dose.||
1392|112|P|Consult your doctor before breastfeeding.||
1392|113|B|||
1392|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1392|115|I|medications work or increase your risk for serious side effects.||
1392|116|I|This document does not contain all possible drug interactions.||
1392|117|I|Keep a list of all the products you use (including||
1392|118|I|prescription/nonprescription drugs and herbal products) and share||
1392|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
1392|120|I|the dosage of any medicines without your doctor's approval.||
1392|121|I|   A product that may interact with this drug include:||
1392|122|I|vemurafenib.||
1392|123|B|||
1392|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1392|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1392|126|O|poison control center right away. US residents can call||
1392|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1392|128|B|||
1392|129|N|NOTES:  Lab and/or medical tests (such as liver/thyroid/kidney||
1392|130|N|function, ACTH blood levels) should be done while you are using||
1392|131|N|this medication. Keep all medical and lab appointments. Consult||
1392|132|N|your doctor for more details.||
1392|133|B|||
1392|134|D|MISSED DOSE:  It is important to get each dose of this medication||
1392|135|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1392|136|D|right away for a new dosing schedule.||
1392|137|B|||
1392|138|R|STORAGE:  Not applicable. This medication is given in a clinic||
1392|139|R|and will not be stored at home.||
1392|140|B|||
1392|141|A|Information last revised February 2025.||
1392|142|A|Copyright(c) 2025 First Databank, Inc.||
1392|143|B|||
1393|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1393|002|Z|does NOT have all possible information about this product. This||
1393|003|Z|information does not assure that this product is safe, effective,||
1393|004|Z|or appropriate for you. This information is not individual||
1393|005|Z|medical advice and does not substitute for the advice of your||
1393|006|Z|health care professional. Always ask your health care||
1393|007|Z|professional for complete information about this product and your||
1393|008|Z|specific health needs.||
1393|009|B|||
1393|010|T|DASIGLUCAGON - SUBCUTANEOUS INJECTION||
1393|011|F|(DAS-i-GLOO-ka-gon)||
1393|012|B|||
1393|013|C|COMMON BRAND NAME(S): Zegalogue||
1393|014|B|||
1393|015|U|USES:  This medication is like your body's own glucagon, a||
1393|016|U|natural substance that raises blood sugar by causing the body to||
1393|017|U|release sugar stored in the liver. It is used to treat very low||
1393|018|U|blood sugar (hypoglycemia) that may cause you to need help from||
1393|019|U|others. Before you need help, make sure a family member or||
1393|020|U|caregiver knows where you keep this medication and how to use it.||
1393|021|B|||
1393|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
1393|023|H|Instructions for Use Leaflet provided by your pharmacist when you||
1393|024|H|get this medication and each time you get a refill. If you have||
1393|025|H|any questions, ask your doctor or pharmacist.||
1393|026|H|   An episode of very low blood sugar should be treated right||
1393|027|H|away to prevent serious effects (such as brain damage). Be sure||
1393|028|H|to keep this medication handy in case it is needed. You and your||
1393|029|H|caregiver must learn ahead of time how to properly give this||
1393|030|H|medication. Each autoinjector/syringe can be used only one time.||
1393|031|H|Caregivers should also know the symptoms of low blood sugar (see||
1393|032|H|also Precautions section).||
1393|033|H|   Remove the autoinjector/syringe from the package only when you||
1393|034|H|are ready to use it. Before using, check this product for||
1393|035|H|particles or discoloration. If either is present, do not use the||
1393|036|H|liquid. Learn how to store and discard medical supplies safely.||
1393|037|H|   Inject this medication under the skin as directed by your||
1393|038|H|doctor. It should not be injected through clothing. The injection||
1393|039|H|is given in the abdomen, thigh, buttocks, or upper arm. The||
1393|040|H|dosage is based on your medical condition and response to||
1393|041|H|treatment. After giving this medication, the caregiver should get||
1393|042|H|medical help right away.||
1393|043|H|   If the patient is unconscious, turn them on their side to||
1393|044|H|prevent choking in case they vomit. If they do not wake up after||
1393|045|H|15 minutes, another dose may be given, if available.||
1393|046|H|   When the patient wakes up and is able to swallow, a quick||
1393|047|H|sugar source (such as glucose tablets, juice) should be given.||
1393|048|H|Dasiglucagon is only effective for a short time, and low blood||
1393|049|H|sugar may return. The blood sugar level should be kept up by||
1393|050|H|eating snacks such as crackers, cheese, a meat sandwich, or milk.||
1393|051|H|   Always call your doctor right away when an episode of very low||
1393|052|H|blood sugar has happened. You may need more medical treatment, or||
1393|053|H|your insulin dose and diet may need to be adjusted.||
1393|054|B|||
1393|055|S|SIDE EFFECTS:  Nausea, vomiting, or headache may occur.||
1393|056|S|Irritation, redness, or swelling at the injection site may also||
1393|057|S|occur. If any of these effects last or get worse, tell your||
1393|058|S|doctor or pharmacist promptly.||
1393|059|S|   Remember that this medication has been prescribed because your||
1393|060|S|doctor has judged that the benefit to you is greater than the||
1393|061|S|risk of side effects. Many people using this medication do not||
1393|062|S|have serious side effects.||
1393|063|S|   Tell your doctor right away if you have any serious side||
1393|064|S|effects, including: fast/pounding heartbeat.||
1393|065|S|   A very serious allergic reaction to this drug is rare.||
1393|066|S|However, get medical help right away if you notice any symptoms||
1393|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1393|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1393|069|S|breathing.||
1393|070|S|   This is not a complete list of possible side effects. If you||
1393|071|S|notice other effects not listed above, contact your doctor or||
1393|072|S|pharmacist.||
1393|073|S|   In the US -||
1393|074|S|   Call your doctor for medical advice about side effects. You||
1393|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1393|076|S|www.fda.gov/medwatch.||
1393|077|S|   In Canada - Call your doctor for medical advice about side||
1393|078|S|effects. You may report side effects to Health Canada at||
1393|079|S|1-866-234-2345.||
1393|080|B|||
1393|081|P|PRECAUTIONS:  Before using dasiglucagon, tell your doctor or||
1393|082|P|pharmacist if you are allergic to it; or if you have any other||
1393|083|P|allergies. This product may contain inactive ingredients, which||
1393|084|P|can cause allergic reactions or other problems. Talk to your||
1393|085|P|pharmacist for more details.||
1393|086|P|   Before using this medication, tell your doctor or pharmacist||
1393|087|P|your medical history, especially of: tumor of the pancreas||
1393|088|P|(insulinoma), adrenal gland problem (such as Addison's disease,||
1393|089|P|pheochromocytoma), not eating/poor eating habits, frequent low||
1393|090|P|blood sugar.||
1393|091|P|   Low blood sugar (hypoglycemia) is more likely if you do not||
1393|092|P|consume enough calories from food, or if you do unusually heavy||
1393|093|P|exercise. Symptoms include sudden sweating, shaking, fast||
1393|094|P|heartbeat, hunger, blurred vision, dizziness, or tingling||
1393|095|P|hands/feet. It is a good habit to carry glucose tablets or gel to||
1393|096|P|treat low blood sugar. If you don't have these reliable forms of||
1393|097|P|glucose, rapidly raise your blood sugar by eating a quick source||
1393|098|P|of sugar such as table sugar, honey, or candy, or drink fruit||
1393|099|P|juice or non-diet soda. Tell your doctor right away about the||
1393|100|P|reaction and the use of this product. To help prevent low blood||
1393|101|P|sugar, eat meals on a regular schedule, and do not skip meals.||
1393|102|P|Check with your doctor or pharmacist to find out what you should||
1393|103|P|do if you miss a meal.||
1393|104|P|   Tell your doctor if you are pregnant before using this||
1393|105|P|medication.||
1393|106|P|   It is unknown if this drug passes into breast milk, but it is||
1393|107|P|unlikely to harm a nursing infant. Consult your doctor before||
1393|108|P|breastfeeding.||
1393|109|B|||
1393|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1393|111|I|medications work or increase your risk for serious side effects.||
1393|112|I|This document does not contain all possible drug interactions.||
1393|113|I|Keep a list of all the products you use (including||
1393|114|I|prescription/nonprescription drugs and herbal products) and share||
1393|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
1393|116|I|the dosage of any medicines without your doctor's approval.||
1393|117|B|||
1393|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1393|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1393|120|O|poison control center right away. US residents can call||
1393|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1393|122|B|||
1393|123|N|NOTES:  Do not share this medication with others.||
1393|124|N|   Attend a diabetes education program to learn more about how to||
1393|125|N|manage your diabetes with medications, diet, exercise, and||
1393|126|N|regular medical exams.||
1393|127|N|   Learn the symptoms of high and low blood sugar and how to||
1393|128|N|treat low blood sugar. Check your blood sugar regularly as||
1393|129|N|directed.||
1393|130|B|||
1393|131|D|MISSED DOSE:  Not applicable.||
1393|132|B|||
1393|133|R|STORAGE:  Store in the refrigerator away from light. Do not||
1393|134|R|freeze. This medication can also be stored at room temperature if||
1393|135|R|needed. If the medication is stored at room temperature, do not||
1393|136|R|put it back in the refrigerator and discard after 12 months. Keep||
1393|137|R|all medications away from children and pets.||
1393|138|R|   Do not flush medications down the toilet or pour them into a||
1393|139|R|drain unless instructed to do so. Properly discard this product||
1393|140|R|when it is expired or no longer needed. Consult your pharmacist||
1393|141|R|or local waste disposal company.||
1393|142|B|||
1393|143|M|MEDICAL ALERT:  Your condition can cause complications in a||
1393|144|M|medical emergency. For information about enrolling in MedicAlert,||
1393|145|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1393|146|B|||
1393|147|A|Information last revised October 2024.||
1393|148|A|Copyright(c) 2025 First Databank, Inc.||
1393|149|B|||
1394|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1394|002|Z|does NOT have all possible information about this product. This||
1394|003|Z|information does not assure that this product is safe, effective,||
1394|004|Z|or appropriate for you. This information is not individual||
1394|005|Z|medical advice and does not substitute for the advice of your||
1394|006|Z|health care professional. Always ask your health care||
1394|007|Z|professional for complete information about this product and your||
1394|008|Z|specific health needs.||
1394|009|B|||
1394|010|T|DROSPIRENONE/ESTETROL - ORAL||
1394|011|F|(droe-SPYE-re-none/ES-te-trol)||
1394|012|B|||
1394|013|C|COMMON BRAND NAME(S): Nextstellis||
1394|014|B|||
1394|015|W|WARNING:  Smoking raises your risk of stroke, heart attack, blood||
1394|016|W|clots, and high blood pressure from hormonal birth control (such||
1394|017|W|as the pill, patch, ring). The risk of these serious problems||
1394|018|W|increases with age and with the number of cigarettes you smoke.||
1394|019|W|Do not smoke or use tobacco. Do not use this medication if you||
1394|020|W|smoke cigarettes/use tobacco and are over 35 years old.||
1394|021|B|||
1394|022|U|USES:  This medication is a combination of 2 hormones: an||
1394|023|U|estrogen (estetrol) and a progestin (drospirenone). This product||
1394|024|U|is used to prevent pregnancy.||
1394|025|U|   Besides preventing pregnancy, birth control pills may make||
1394|026|U|your periods more regular, decrease blood loss and painful||
1394|027|U|periods, and decrease your risk of ovarian cysts.||
1394|028|U|   This medication does not protect against sexually transmitted||
1394|029|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1394|030|U|an effective barrier method (latex or polyurethane condom/dental||
1394|031|U|dams) during sexual activity will help to decrease your risk of||
1394|032|U|infection.||
1394|033|B|||
1394|034|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1394|035|H|your pharmacist before you start using this product and each time||
1394|036|H|you get a refill. The leaflet contains very important information||
1394|037|H|on when to take your pills and what to do if you miss a dose. If||
1394|038|H|you have any questions, ask your doctor or pharmacist.||
1394|039|H|   Take this medication by mouth as directed by your doctor, with||
1394|040|H|or without food, usually once daily. Pick a time of day that is||
1394|041|H|easy for you to remember, and take your pill at the same time||
1394|042|H|each day, 24 hours apart.||
1394|043|H|   Taking this medication after your evening meal or at bedtime||
1394|044|H|may help if you have stomach upset or nausea with the medication.||
1394|045|H|You may choose to take this medication at another time of day||
1394|046|H|that is easier for you to remember. No matter what dosing||
1394|047|H|schedule you use, it is very important that you take this||
1394|048|H|medication at the same time each day, 24 hours apart.||
1394|049|H|   Follow the package instructions to find the first tablet,||
1394|050|H|start with the first tablet in the pack, and take them in the||
1394|051|H|correct order. Do not skip any doses. Pregnancy is more likely if||
1394|052|H|you miss pills, start a new pack late, or take your pill at a||
1394|053|H|different time of the day than usual.||
1394|054|H|   Vomiting or diarrhea can prevent your birth control pills from||
1394|055|H|working well. If you have vomiting or diarrhea, you may need to||
1394|056|H|use a backup birth control method (such as condoms, spermicide).||
1394|057|H|Follow the directions in the Patient Information Leaflet and||
1394|058|H|check with your doctor or pharmacist for more details.||
1394|059|H|   Your pill pack contains 24 pills with active medication (with||
1394|060|H|hormones). It also contains 4 reminder pills (without hormones)||
1394|061|H|at the end of the pack. Take one active pill (with hormones) once||
1394|062|H|daily for 24 days in a row. After you have taken the last active||
1394|063|H|pill, take a reminder pill (without hormones) once daily for 4||
1394|064|H|days in a row unless otherwise directed by your doctor. You||
1394|065|H|should have your period within 3 days after you take the last||
1394|066|H|active tablet in the cycle during the fourth week of the pack.||
1394|067|H|After you have taken the last inactive tablet in the pack, start||
1394|068|H|a new pack the next day whether or not you have your period. If||
1394|069|H|you do not get your period, consult your doctor.||
1394|070|H|   If this is the first time you are using this medication and||
1394|071|H|you are not switching from another form of hormonal birth control||
1394|072|H|(such as the patch, other birth control pills), take the first||
1394|073|H|tablet in the pack on the first day of your period. If you start||
1394|074|H|on the first day of your period, you do not need to use backup||
1394|075|H|birth control the first week. For the first cycle of use only,||
1394|076|H|use a backup form of non-hormonal birth control (such as condoms,||
1394|077|H|spermicide) for the first 7 days if you are instructed to start||
1394|078|H|this medication on any day other than the first day of your||
1394|079|H|period.||
1394|080|H|   Ask your doctor or pharmacist for information about how to||
1394|081|H|switch from other forms of hormonal birth control (such as patch,||
1394|082|H|other birth control pills) to this product. If any information is||
1394|083|H|unclear, consult the Patient Information Leaflet or your doctor||
1394|084|H|or pharmacist.||
1394|085|B|||
1394|086|S|SIDE EFFECTS:  Nausea, vomiting, headache, abdominal||
1394|087|S|cramps/bloating, breast tenderness, swelling of the ankles/feet||
1394|088|S|(retaining fluid), or weight change may occur. Vaginal bleeding||
1394|089|S|between periods (spotting) or missed/irregular periods may occur,||
1394|090|S|especially during the first few months of use. If any of these||
1394|091|S|effects last or get worse, tell your doctor or pharmacist||
1394|092|S|promptly. If you miss 2 periods in a row (or 1 period if the pill||
1394|093|S|has not been used properly), contact your doctor for a pregnancy||
1394|094|S|test.||
1394|095|S|   Remember that this medication has been prescribed because your||
1394|096|S|doctor has judged that the benefit to you is greater than the||
1394|097|S|risk of side effects. Many people using this medication do not||
1394|098|S|have serious side effects.||
1394|099|S|   This medication may raise your blood pressure. Check your||
1394|100|S|blood pressure regularly and tell your doctor if the results are||
1394|101|S|high.||
1394|102|S|   Tell your doctor right away if you have any serious side||
1394|103|S|effects, including: unusual changes in vaginal bleeding (such as||
1394|104|S|continuous spotting, sudden heavy bleeding, missed periods),||
1394|105|S|symptoms of a high potassium blood level (such as muscle||
1394|106|S|weakness, slow/irregular heartbeat).||
1394|107|S|   This medication may rarely cause serious (sometimes fatal)||
1394|108|S|problems from blood clots (such as heart attack, stroke, blood||
1394|109|S|clots in the lungs or legs). Get medical help right away if you||
1394|110|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1394|111|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
1394|112|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1394|113|S|trouble speaking, weakness on one side of the body, sudden vision||
1394|114|S|changes.||
1394|115|S|   Get medical help right away if you have any very serious side||
1394|116|S|effects, including: lumps in the breast, severe stomach/abdominal||
1394|117|S|pain, dark urine, yellowing eyes/skin, mental/mood changes (such||
1394|118|S|as new/worsening depression, suicidal thoughts).||
1394|119|S|   A very serious allergic reaction to this drug is rare.||
1394|120|S|However, get medical help right away if you notice any symptoms||
1394|121|S|of a serious allergic reaction, including: rash, itching/swelling||
1394|122|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1394|123|S|breathing.||
1394|124|S|   This is not a complete list of possible side effects. If you||
1394|125|S|notice other effects not listed above, contact your doctor or||
1394|126|S|pharmacist.||
1394|127|S|   In the US -||
1394|128|S|   Call your doctor for medical advice about side effects. You||
1394|129|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1394|130|S|www.fda.gov/medwatch.||
1394|131|S|   In Canada - Call your doctor for medical advice about side||
1394|132|S|effects. You may report side effects to Health Canada at||
1394|133|S|1-866-234-2345.||
1394|134|B|||
1394|135|P|PRECAUTIONS:  See also Warning section.||
1394|136|P|   Before using this medication, tell your doctor or pharmacist||
1394|137|P|if you are allergic to estetrol or drospirenone; or to other||
1394|138|P|estrogens or progestins; or if you have any other allergies. This||
1394|139|P|product may contain inactive ingredients, which can cause||
1394|140|P|allergic reactions or other problems. Talk to your pharmacist for||
1394|141|P|more details.||
1394|142|P|   Before using this product, tell your doctor or pharmacist your||
1394|143|P|medical history, especially of: adrenal gland problems, stroke,||
1394|144|P|blood clots (such as in the legs, eyes, lungs), high blood||
1394|145|P|pressure, abnormal breast exam, cancer (especially endometrial or||
1394|146|P|breast cancer), blood clotting disorders (such as protein C or||
1394|147|P|protein S deficiency), diabetes, severe headaches/migraines,||
1394|148|P|family or personal history of a certain swelling disorder||
1394|149|P|(angioedema), heart problems (such as heart valve disease,||
1394|150|P|irregular heartbeat, previous heart attack), kidney disease,||
1394|151|P|liver disease (including tumors), history of yellowing eyes/skin||
1394|152|P|(jaundice) during pregnancy or while using birth control pills,||
1394|153|P|unexplained vaginal bleeding, high cholesterol or triglyceride||
1394|154|P|(blood fat) levels, depression, swelling (edema), gallbladder||
1394|155|P|problems, obesity.||
1394|156|P|   If you have diabetes, this medication may affect your blood||
1394|157|P|sugar. Check your blood sugar regularly as directed and share the||
1394|158|P|results with your doctor. Tell your doctor right away if you have||
1394|159|P|symptoms of high blood sugar such as increased thirst/urination.||
1394|160|P|Your doctor may need to adjust your diabetes medication, exercise||
1394|161|P|program, or diet.||
1394|162|P|   Tell your doctor if you just had or will be having surgery or||
1394|163|P|if you will be confined to a bed or chair for a long time (such||
1394|164|P|as on a long plane flight). These conditions increase your risk||
1394|165|P|of getting blood clots, especially if you are using hormonal||
1394|166|P|birth control. You may need to stop this medication for a time or||
1394|167|P|take special precautions.||
1394|168|P|   This product may increase your potassium levels. Before using||
1394|169|P|potassium supplements or salt substitutes that contain potassium,||
1394|170|P|consult your doctor or pharmacist.||
1394|171|P|   This medication may cause blotchy, dark areas on your skin||
1394|172|P|(melasma). Sunlight may worsen this effect. Avoid prolonged sun||
1394|173|P|exposure, sunlamps, and tanning booths. Use a sunscreen, and wear||
1394|174|P|protective clothing when outdoors.||
1394|175|P|   If you are nearsighted or wear contact lenses, you may develop||
1394|176|P|vision problems or trouble wearing your contact lenses. Contact||
1394|177|P|your eye doctor if these problems occur.||
1394|178|P|   It may take longer for you to become pregnant after you stop||
1394|179|P|taking birth control pills. Consult your doctor.||
1394|180|P|   This medication must not be used during pregnancy. If you||
1394|181|P|become pregnant or think you may be pregnant, tell your doctor||
1394|182|P|right away. If you have just given birth or had a pregnancy||
1394|183|P|loss/abortion after the first 3 months, talk with your doctor||
1394|184|P|about reliable forms of birth control, and find out when it is||
1394|185|P|safe to start using birth control that contains a form of||
1394|186|P|estrogen, such as this medication.||
1394|187|P|   This medication passes into breast milk and may harm a nursing||
1394|188|P|infant. Consult your doctor before breastfeeding.||
1394|189|B|||
1394|190|I|DRUG INTERACTIONS:  See also Precautions section.||
1394|191|I|   Drug interactions may change how your medications work or||
1394|192|I|increase your risk for serious side effects. This document does||
1394|193|I|not contain all possible drug interactions. Keep a list of all||
1394|194|I|the products you use (including prescription/nonprescription||
1394|195|I|drugs and herbal products) and share it with your doctor and||
1394|196|I|pharmacist. Do not start, stop, or change the dosage of any||
1394|197|I|medicines without your doctor's approval.||
1394|198|I|   Some products that may interact with this drug are: aromatase||
1394|199|I|inhibitors (such as anastrozole, exemestane),||
1394|200|I|atazanavir/cobicistat, fezolinetant, ospemifene, tamoxifen,||
1394|201|I|tizanidine, tranexamic acid.||
1394|202|I|   Drospirenone may raise your potassium blood level. Tell your||
1394|203|I|doctor if you are regularly taking other drugs/products that can||
1394|204|I|also raise your potassium level (including aliskiren, ACE||
1394|205|I|inhibitors such as enalapril/lisinopril, angiotensin receptor||
1394|206|I|blockers such as losartan/valsartan, heparin, NSAIDs such as||
1394|207|I|ibuprofen/naproxen, potassium-sparing "water pills"/diuretics||
1394|208|I|such as eplerenone/spironolactone/triamterene).||
1394|209|I|   Some drugs may cause hormonal birth control to work less well||
1394|210|I|by decreasing the amount of birth control hormones in your body.||
1394|211|I|This effect can result in pregnancy. Examples include||
1394|212|I|griseofulvin, modafinil, rifamycins (such as rifampin),||
1394|213|I|ritonavir, St. John's wort, drugs used to treat seizures (such as||
1394|214|I|barbiturates, carbamazepine, felbamate, phenytoin, primidone,||
1394|215|I|topiramate), HIV drugs (such as nelfinavir, nevirapine), among||
1394|216|I|others. Ask your doctor or pharmacist for more details.||
1394|217|I|   Tell your doctor when you start any new drug, and discuss if||
1394|218|I|you should use reliable backup birth control. Also tell your||
1394|219|I|doctor if you have any new spotting or breakthrough bleeding,||
1394|220|I|because these may be signs that your birth control is not working||
1394|221|I|well.||
1394|222|I|   This medication can affect the results of many lab tests. Make||
1394|223|I|sure lab personnel and all your doctors know you use this||
1394|224|I|medication.||
1394|225|B|||
1394|226|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1394|227|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1394|228|O|poison control center right away. US residents can call||
1394|229|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1394|230|O|Symptoms of overdose may include: severe nausea and vomiting,||
1394|231|O|sudden/unusual vaginal bleeding.||
1394|232|B|||
1394|233|N|NOTES:  Do not share this medication with others.||
1394|234|N|   You should have regular complete physical exams including||
1394|235|N|blood pressure, breast exam, pelvic exam, and screening for||
1394|236|N|cervical cancer (Pap smear). Follow your doctor's instructions||
1394|237|N|for examining your breasts, and report any lumps right away. Keep||
1394|238|N|all medical and lab appointments. Consult your doctor for more||
1394|239|N|details.||
1394|240|B|||
1394|241|D|MISSED DOSE:  Refer to the product package information for advice||
1394|242|D|on missed doses. You may need to use backup birth control (such||
1394|243|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
1394|244|D|pharmacist if you have any questions.||
1394|245|D|   If you often forget to take your pills as directed, contact||
1394|246|D|your doctor to discuss switching to another form of birth||
1394|247|D|control.||
1394|248|B|||
1394|249|R|STORAGE:  Store at room temperature away from light and moisture.||
1394|250|R|Do not store in the bathroom. Keep all medications away from||
1394|251|R|children and pets.||
1394|252|R|   Do not flush medications down the toilet or pour them into a||
1394|253|R|drain unless instructed to do so. Properly discard this product||
1394|254|R|when it is expired or no longer needed. Consult your pharmacist||
1394|255|R|or local waste disposal company.||
1394|256|B|||
1394|257|A|Information last revised October 2025.||
1394|258|A|Copyright(c) 2025 First Databank, Inc.||
1394|259|B|||
1396|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1396|002|Z|does NOT have all possible information about this product. This||
1396|003|Z|information does not assure that this product is safe, effective,||
1396|004|Z|or appropriate for you. This information is not individual||
1396|005|Z|medical advice and does not substitute for the advice of your||
1396|006|Z|health care professional. Always ask your health care||
1396|007|Z|professional for complete information about this product and your||
1396|008|Z|specific health needs.||
1396|009|B|||
1396|010|T|IMMUNE GLOBULIN - INTRAVENOUS/SUBCUTANEOUS INJECTION||
1396|011|F|(i-MUNE GLOB-ue-lin)||
1396|012|B|||
1396|013|C|COMMON BRAND NAME(S): Gammagard, Gamunex-C||
1396|014|B|||
1396|015|W|WARNING:  This medication may cause serious (rarely fatal) kidney||
1396|016|W|problems. This risk is higher if you have kidney problems,||
1396|017|W|diabetes, a serious blood infection (sepsis), a certain blood||
1396|018|W|problem (paraproteinemia), or a severe loss of body fluids||
1396|019|W|(dehydration), as well as if you are older than 65 years or are||
1396|020|W|using other drugs that may harm the kidneys (such as gentamicin).||
1396|021|W|   This medication may also rarely cause serious problems from||
1396|022|W|blood clots (such as heart attack, stroke, blood clots in the||
1396|023|W|lungs or legs). You may be at increased risk for blood clots if||
1396|024|W|you are an older adult, are severely dehydrated, have a catheter||
1396|025|W|in a vein close to your heart for giving medications, or have a||
1396|026|W|history of blood clots, heart/blood vessel disease, heart||
1396|027|W|failure, stroke, or if you are immobile (such as very long plane||
1396|028|W|flights or bedridden). If you use estrogen-containing products,||
1396|029|W|these may also increase your risk.||
1396|030|W|   Before using this medication, discuss the risks and benefits||
1396|031|W|and if you have any of these conditions, report them to your||
1396|032|W|doctor or pharmacist. The risk of kidney problems and blood clots||
1396|033|W|may be decreased by infusing this medication more slowly or by||
1396|034|W|using a less concentrated form of this medication if available.||
1396|035|W|Being adequately hydrated before receiving this medication may||
1396|036|W|also help reduce these risks.||
1396|037|W|   Get medical help right away if any of these side effects||
1396|038|W|occur: sudden weight gain, swelling of the hands/ankles/feet, a||
1396|039|W|change in the amount of urine, shortness of breath/rapid||
1396|040|W|breathing, chest/jaw/left arm pain, unusual sweating, sudden||
1396|041|W|dizziness/fainting, pain/swelling/warmth in the arm/leg,||
1396|042|W|sudden/severe headache, trouble speaking, weakness on one side of||
1396|043|W|the body, sudden vision changes, or confusion.||
1396|044|B|||
1396|045|U|USES:  This medication is used in people with a certain type of||
1396|046|U|weakened immune system (primary immune deficiency) to strengthen||
1396|047|U|it and to lower the risk of infection. This medication is made||
1396|048|U|from human blood that has a high level of antibodies which help||
1396|049|U|fight infections.||
1396|050|U|   This product is also used to increase the number of certain||
1396|051|U|blood cells (platelets) in people with a certain blood disorder||
1396|052|U|(idiopathic thrombocytopenic purpura-ITP). Platelets are needed||
1396|053|U|to stop bleeding and to form normal blood clots.||
1396|054|U|   In addition, this medication is used to treat a certain nerve||
1396|055|U|disorder (chronic inflammatory demyelinating||
1396|056|U|polyneuropathy-CIDP). This disorder causes weakness and||
1396|057|U|numbness/tingling/pain in the arms and legs. This medication||
1396|058|U|helps to improve these symptoms and prevents relapse.||
1396|059|B|||
1396|060|H|HOW TO USE:  Read the Patient Information Leaflet and||
1396|061|H|Instructions for Use if available from your pharmacist before you||
1396|062|H|start using this medication and each time you get a refill. If||
1396|063|H|you have any questions, ask your doctor or pharmacist.||
1396|064|H|   This medication is usually given by slow injection (infusion)||
1396|065|H|into a vein by a health care professional. The dosage is based on||
1396|066|H|your medical condition, weight, and response to treatment.||
1396|067|H|   If you have primary immune deficiency and respond well to this||
1396|068|H|medication, your doctor may allow you to give this treatment at||
1396|069|H|home. In this case, give this medication by infusion under the||
1396|070|H|skin as directed by your doctor, usually once a week.||
1396|071|H|   If you are using this medication at home, learn all||
1396|072|H|preparation and usage instructions from your health care||
1396|073|H|professional and the product package. Let the medication vials||
1396|074|H|come to room temperature before preparing the infusion. Do not||
1396|075|H|shake the vials. Before using, check this product for particles||
1396|076|H|or discoloration. If either is present, do not use the liquid.||
1396|077|H|Before injecting each dose, clean the skin you are going to||
1396|078|H|inject into (the injection site) with rubbing alcohol. Change the||
1396|079|H|injection site(s) each time to lessen injury under the skin. To||
1396|080|H|lessen bruising, do not rub the injection site after each dose.||
1396|081|H|Learn how to store and discard medical supplies safely.||
1396|082|H|   Use this medication regularly to get the most benefit from it.||
1396|083|H|To help you remember, mark your calendar with a reminder.||
1396|084|B|||
1396|085|S|SIDE EFFECTS:  See also Warning section.||
1396|086|S|   Headache, dizziness, fever, chills, back/joint pain, nausea,||
1396|087|S|vomiting, cough, or pain/redness/swelling at the injection site||
1396|088|S|may occur. If any of these effects last or get worse, tell your||
1396|089|S|doctor or health care professional promptly.||
1396|090|S|   Remember that this medication has been prescribed because your||
1396|091|S|doctor has judged that the benefit to you is greater than the||
1396|092|S|risk of side effects. Many people using this medication do not||
1396|093|S|have serious side effects.||
1396|094|S|   Tell your doctor right away if you have any serious side||
1396|095|S|effects, including: fast heartbeat, unusual tiredness.||
1396|096|S|   Treatment with this medication may rarely cause a serious||
1396|097|S|inflammation of the brain (aseptic meningitis syndrome) several||
1396|098|S|hours to 2 days after your treatment. Get medical help right away||
1396|099|S|if you develop severe headache, stiff neck, drowsiness, fever,||
1396|100|S|sensitivity to light, eye pain, or nausea/vomiting.||
1396|101|S|   Lung problems may rarely occur 1 to 6 hours after your||
1396|102|S|treatment. Get medical help right away if you develop trouble||
1396|103|S|breathing, chest pain, blue lips/skin, or fever.||
1396|104|S|   A very serious allergic reaction to this drug is rare.||
1396|105|S|However, get medical help right away if you notice any symptoms||
1396|106|S|of a serious allergic reaction, including: rash, itching/swelling||
1396|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1396|108|S|breathing.||
1396|109|S|   This is not a complete list of possible side effects. If you||
1396|110|S|notice other effects not listed above, contact your doctor or||
1396|111|S|pharmacist.||
1396|112|S|   In the US -||
1396|113|S|   Call your doctor for medical advice about side effects. You||
1396|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1396|115|S|www.fda.gov/medwatch.||
1396|116|S|   In Canada - Call your doctor for medical advice about side||
1396|117|S|effects. You may report side effects to Health Canada at||
1396|118|S|1-866-234-2345.||
1396|119|B|||
1396|120|P|PRECAUTIONS:  See also Warning section.||
1396|121|P|   Before using this medication, tell your doctor or pharmacist||
1396|122|P|if you are allergic to it; or to other immune globulin products;||
1396|123|P|or if you have any other allergies. This product may contain||
1396|124|P|inactive ingredients, which can cause allergic reactions or other||
1396|125|P|problems. Talk to your pharmacist for more details.||
1396|126|P|   Before using this medication, tell your doctor or pharmacist||
1396|127|P|your medical history, especially of: blood clotting problems,||
1396|128|P|immunoglobulin A deficiency, kidney disease.||
1396|129|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1396|130|P|can make you more dizzy. Do not drive, use machinery, or do||
1396|131|P|anything that needs alertness until you can do it safely. Limit||
1396|132|P|alcoholic beverages. Talk to your doctor if you are using||
1396|133|P|marijuana (cannabis).||
1396|134|P|   Before having surgery, tell your doctor or dentist about all||
1396|135|P|the products you use (including prescription drugs,||
1396|136|P|nonprescription drugs, and herbal products).||
1396|137|P|   Tell your doctor of any recent or planned||
1396|138|P|immunizations/vaccinations. This medication may prevent a good||
1396|139|P|response to certain live viral vaccines (such as measles, mumps,||
1396|140|P|rubella, varicella). If you have recently received any of these||
1396|141|P|vaccines, your doctor may have you tested for a response or have||
1396|142|P|you vaccinated again later. If you plan on getting any of these||
1396|143|P|vaccines, your doctor will instruct you about the best time to||
1396|144|P|receive them so you get a good response. Also tell your doctor if||
1396|145|P|you plan to travel to areas that have a measles outbreak or if||
1396|146|P|you have been exposed to measles.||
1396|147|P|   This medication is made from human blood. Even though the||
1396|148|P|blood is carefully tested, and this medication goes through a||
1396|149|P|special manufacturing process, there is an extremely small chance||
1396|150|P|that you may get infections from the medication (for example,||
1396|151|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
1396|152|P|more information.||
1396|153|P|   Children may be more sensitive to the side effects of this||
1396|154|P|medication, especially fever and vomiting.||
1396|155|P|   Older adults may be more sensitive to the side effects of the||
1396|156|P|drug, especially kidney problems.||
1396|157|P|   During pregnancy, this medication should be used only when||
1396|158|P|clearly needed. Discuss the risks and benefits with your doctor.||
1396|159|P|   It is unknown if this drug passes into breast milk. Consult||
1396|160|P|your doctor before breastfeeding.||
1396|161|B|||
1396|162|I|DRUG INTERACTIONS:  See also Warning and Precautions sections.||
1396|163|I|   Drug interactions may change how your medications work or||
1396|164|I|increase your risk for serious side effects. This document does||
1396|165|I|not contain all possible drug interactions. Keep a list of all||
1396|166|I|the products you use (including prescription/nonprescription||
1396|167|I|drugs and herbal products) and share it with your doctor and||
1396|168|I|pharmacist. Do not start, stop, or change the dosage of any||
1396|169|I|medicines without your doctor's approval.||
1396|170|I|   This medication may interfere with certain lab tests (such as||
1396|171|I|blood type), possibly causing false test results. Make sure lab||
1396|172|I|personnel and all your doctors know you use this drug.||
1396|173|B|||
1396|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1396|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1396|176|O|poison control center right away. US residents can call||
1396|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1396|178|B|||
1396|179|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
1396|180|N|blood tests, immunoglobulin levels, kidney/liver function, urine||
1396|181|N|volume) should be done while you are using this medication. Keep||
1396|182|N|all medical and lab appointments. Consult your doctor for more||
1396|183|N|details.||
1396|184|B|||
1396|185|D|MISSED DOSE:  It is important to get each dose of this medication||
1396|186|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1396|187|D|right away for a new dosing schedule.||
1396|188|B|||
1396|189|R|STORAGE:  Store in the refrigerator. Do not freeze. Refer to the||
1396|190|R|manufacturer's instructions or your pharmacist for other storage||
1396|191|R|details. Discard any unused portion of an opened vial. Keep all||
1396|192|R|medications away from children and pets.||
1396|193|R|   Do not flush medications down the toilet or pour them into a||
1396|194|R|drain unless instructed to do so. Properly discard this product||
1396|195|R|when it is expired or no longer needed. Consult your pharmacist||
1396|196|R|or local waste disposal company.||
1396|197|B|||
1396|198|A|Information last revised June 2025.||
1396|199|A|Copyright(c) 2025 First Databank, Inc.||
1396|200|B|||
1397|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1397|002|Z|does NOT have all possible information about this product. This||
1397|003|Z|information does not assure that this product is safe, effective,||
1397|004|Z|or appropriate for you. This information is not individual||
1397|005|Z|medical advice and does not substitute for the advice of your||
1397|006|Z|health care professional. Always ask your health care||
1397|007|Z|professional for complete information about this product and your||
1397|008|Z|specific health needs.||
1397|009|B|||
1397|010|T|TESTOSTERONE GEL PUMP 2% - TRANSDERMAL||
1397|011|F|(tes-TOS-ter-one)||
1397|012|B|||
1397|013|C|COMMON BRAND NAME(S): Fortesta||
1397|014|B|||
1397|015|W|WARNING:  Children accidentally exposed to this medication by||
1397|016|W|direct contact with someone using it may absorb this drug through||
1397|017|W|their skin. If this occurs, the child may have unwanted side||
1397|018|W|effects due to testosterone gel. Children should avoid contact||
1397|019|W|with any unwashed or unclothed area where the medication has been||
1397|020|W|applied. Tell both of your doctors right away if you notice||
1397|021|W|unexpected signs of puberty in a child such as unusual increase||
1397|022|W|in size of genitals (penis or clitoris), early development of||
1397|023|W|pubic hair, increased erections (in boys) or sex drive, or||
1397|024|W|aggressive behavior. To decrease this risk, carefully follow all||
1397|025|W|directions for the proper use of this drug.||
1397|026|B|||
1397|027|U|USES:  This medicated gel contains testosterone. It is used for||
1397|028|U|hormone replacement in men who are not able to produce enough||
1397|029|U|testosterone (hypogonadism). This medication is absorbed through||
1397|030|U|the skin, enters your bloodstream, and helps your body reach||
1397|031|U|normal testosterone levels.||
1397|032|U|   Testosterone helps the body to develop and maintain the male||
1397|033|U|sexual characteristics (masculinity), such as a deep voice and||
1397|034|U|body hair. It also helps to maintain muscle and prevent bone||
1397|035|U|loss, and is necessary for natural sexual ability/desire.||
1397|036|U|   This drug should not be used by women.||
1397|037|B|||
1397|038|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1397|039|H|provided by your pharmacist before you start using testosterone||
1397|040|H|gel and each time you get a refill. Learn how to use the pump and||
1397|041|H|how to apply the gel correctly. If you have any questions, ask||
1397|042|H|your doctor or pharmacist.||
1397|043|H|   There are many testosterone products available for use on the||
1397|044|H|skin. They may have different amounts of testosterone and may not||
1397|045|H|have the same effects. Read the dosing instructions carefully for||
1397|046|H|each product. Do not change products without asking your doctor||
1397|047|H|or pharmacist.||
1397|048|H|   Follow the instructions for priming the pump if you are using||
1397|049|H|it for the first time.||
1397|050|H|   Apply the medication to clean, dry skin on the front and inner||
1397|051|H|thigh(s) as directed by your doctor, usually once daily in the||
1397|052|H|morning. Pump this medication directly onto the thigh(s). Use one||
1397|053|H|finger to rub the gel in evenly. Apply only to areas that would||
1397|054|H|be fully covered by clothing (shorts or pants). Avoid applying||
1397|055|H|this medication to broken, irritated skin. Do not apply this||
1397|056|H|medication to other areas of the body including to the genitals||
1397|057|H|(penis or scrotum) or to the area of the thighs next to the||
1397|058|H|genitals. Do not let others apply this medication to your body.||
1397|059|H|   The dosage is based on your medical condition, lab tests, and||
1397|060|H|response to treatment. Follow your doctor's instructions||
1397|061|H|carefully on the exact number of pumps for each dose.||
1397|062|H|   After applying this medication, wash your hands thoroughly||
1397|063|H|with soap and water to reduce the risk of accidentally spreading||
1397|064|H|it from your hands to other people. Wait a few minutes for the||
1397|065|H|application site to dry completely before dressing. Be sure to||
1397|066|H|always wear clothing (such as shorts or pants) to cover the||
1397|067|H|application site until you wash the areas well with soap and||
1397|068|H|water. To get the best effect, wait at least 2 hours before||
1397|069|H|showering/swimming to allow the drug to be absorbed through the||
1397|070|H|skin.||
1397|071|H|   Use this medication regularly in order to get the most benefit||
1397|072|H|from it. To help you remember, use it at the same time each day.||
1397|073|H|   Misuse or abuse of testosterone can cause serious side effects||
1397|074|H|such as heart disease (including heart attack), stroke, liver||
1397|075|H|disease, mental/mood problems, abnormal drug-seeking behavior, or||
1397|076|H|improper bone growth (in adolescents). Do not increase your dose||
1397|077|H|or use this drug more often or for longer than prescribed. When||
1397|078|H|testosterone is misused or abused, you may have withdrawal||
1397|079|H|symptoms (such as depression, irritability, tiredness) when you||
1397|080|H|suddenly stop using the drug. These symptoms may last from weeks||
1397|081|H|to months.||
1397|082|H|   This medication is flammable until dry. Avoid smoking or being||
1397|083|H|near open flames while using the medication and until the||
1397|084|H|medication has dried.||
1397|085|H|   Tell your doctor if your condition does not get better or if||
1397|086|H|it gets worse.||
1397|087|B|||
1397|088|S|SIDE EFFECTS:  Redness/irritation at the application site and||
1397|089|S|acne may occur. If any of these effects last or get worse, tell||
1397|090|S|your doctor or pharmacist promptly.||
1397|091|S|   Remember that this medication has been prescribed because your||
1397|092|S|doctor has judged that the benefit to you is greater than the||
1397|093|S|risk of side effects. Many people using this medication do not||
1397|094|S|have serious side effects.||
1397|095|S|   This medication may raise your blood pressure. Check your||
1397|096|S|blood pressure regularly and tell your doctor if the results are||
1397|097|S|high. Your doctor may control your blood pressure with||
1397|098|S|medication.||
1397|099|S|   Tell your doctor right away if you have any serious side||
1397|100|S|effects, including: nausea/vomiting that doesn't stop, severe||
1397|101|S|stomach/abdominal pain, dark urine, yellowing eyes/skin, swelling||
1397|102|S|hands/ankles/feet, breast pain/enlargement, very||
1397|103|S|slow/shallow/difficult breathing (possibly while sleeping),||
1397|104|S|difficulty urinating, increased urination (especially at night),||
1397|105|S|mental/mood changes (such as depression, agitation, hostility),||
1397|106|S|testicle pain/tenderness, fast/irregular heartbeat.||
1397|107|S|   Get medical help right away if you have any very serious side||
1397|108|S|effects, including: shortness of breath/rapid breathing,||
1397|109|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1397|110|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1397|111|S|sudden/severe headaches, trouble speaking, weakness on one side||
1397|112|S|of the body, sudden vision changes.||
1397|113|S|   In patients with diabetes, especially those taking insulin,||
1397|114|S|testosterone may decrease your blood sugar. Be prepared to treat||
1397|115|S|low blood sugar while you are using this medication. Tell your||
1397|116|S|doctor right away if you have symptoms of low blood sugar such as||
1397|117|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
1397|118|S|dizziness, or tingling hands/feet.||
1397|119|S|   Rarely, males may have a painful or prolonged erection lasting||
1397|120|S|4 or more hours. If this occurs, stop using this drug and get||
1397|121|S|medical help right away, or permanent problems could occur.||
1397|122|S|   A very serious allergic reaction to this product is rare.||
1397|123|S|However, get medical help right away if you notice any symptoms||
1397|124|S|of a serious allergic reaction, including: rash, itching/swelling||
1397|125|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1397|126|S|breathing.||
1397|127|S|   This is not a complete list of possible side effects. If you||
1397|128|S|notice other effects not listed above, contact your doctor or||
1397|129|S|pharmacist.||
1397|130|S|   In the US -||
1397|131|S|   Call your doctor for medical advice about side effects. You||
1397|132|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1397|133|S|www.fda.gov/medwatch.||
1397|134|S|   In Canada - Call your doctor for medical advice about side||
1397|135|S|effects. You may report side effects to Health Canada at||
1397|136|S|1-866-234-2345.||
1397|137|B|||
1397|138|P|PRECAUTIONS:  See also Warning section.||
1397|139|P|   Before using testosterone, tell your doctor or pharmacist if||
1397|140|P|you are allergic to it; or if you have any other allergies. This||
1397|141|P|product may contain inactive ingredients, which can cause||
1397|142|P|allergic reactions or other problems. Talk to your pharmacist for||
1397|143|P|more details.||
1397|144|P|   Before using this medication, tell your doctor or pharmacist||
1397|145|P|your medical history, especially of: breast cancer (males),||
1397|146|P|prostate problems (such as cancer, enlarged prostate or BPH),||
1397|147|P|difficulty breathing during sleep (apnea), high cholesterol||
1397|148|P|level, bone cancer, diabetes, high blood pressure, heart problems||
1397|149|P|(such as heart failure, heart attack), stroke, blood clots (such||
1397|150|P|as in the leg, lungs).||
1397|151|P|   Direct contact with the application site can expose others to||
1397|152|P|this medication. Women and children should avoid contact with any||
1397|153|P|unwashed or unclothed area where the medication has been applied.||
1397|154|P|If you expect to have skin-to-skin contact with another person,||
1397|155|P|first wash the application area well with soap and water. If a||
1397|156|P|woman or child makes contact with the application area, that area||
1397|157|P|on the woman or child should be washed well with soap and water||
1397|158|P|right away.||
1397|159|P|   If this medication accidentally gets into your eyes, rinse the||
1397|160|P|eyes right away with clean, warm water. Get medical help right||
1397|161|P|away if necessary.||
1397|162|P|   Before having surgery, tell your doctor or dentist about all||
1397|163|P|the products you use (including prescription drugs,||
1397|164|P|nonprescription drugs, and herbal products).||
1397|165|P|   Some men, particularly older adults, are at a higher risk for||
1397|166|P|developing enlarged prostate or prostate cancer while using this||
1397|167|P|medication. Your risk of prostate problems should be checked by||
1397|168|P|your doctor before you start testosterone.||
1397|169|P|   Children may be more sensitive to the side effects of this||
1397|170|P|drug. In children, it may affect bone growth. Monitor your||
1397|171|P|child's height periodically.||
1397|172|P|   This medication can affect fertility in males. Ask your doctor||
1397|173|P|for more details.||
1397|174|P|   This medication should not be used by women. Women||
1397|175|P|accidentally exposed to this medication may have side effects due||
1397|176|P|to testosterone gel. If you notice symptoms in a woman such as||
1397|177|P|changes in body hair or a large increase in acne, talk to her||
1397|178|P|doctor and your doctor right away. Women who are pregnant or||
1397|179|P|breastfeeding must avoid contact with this medication. This||
1397|180|P|medication may harm an unborn or breastfeeding baby. Consult your||
1397|181|P|doctor for more details.||
1397|182|B|||
1397|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1397|184|I|medications work or increase your risk for serious side effects.||
1397|185|I|This document does not contain all possible drug interactions.||
1397|186|I|Keep a list of all the products you use (including||
1397|187|I|prescription/nonprescription drugs and herbal products) and share||
1397|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
1397|189|I|the dosage of any medicines without your doctor's approval.||
1397|190|I|   Some products that may interact with this drug include: "blood||
1397|191|I|thinners" (such as warfarin).||
1397|192|I|   This medication may interfere with certain lab tests (such as||
1397|193|I|thyroid function tests, creatinine level), possibly causing false||
1397|194|I|test results. Make sure lab personnel and all your doctors know||
1397|195|I|you use this drug.||
1397|196|B|||
1397|197|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1397|198|O|has overdosed and has serious symptoms such as passing out or||
1397|199|O|trouble breathing, call 911. Otherwise, call a poison control||
1397|200|O|center right away. US residents can call 1-800-222-1222. Canada||
1397|201|O|residents can call 1-844-764-7669.||
1397|202|B|||
1397|203|N|NOTES:  Do not share this medication with others. Sharing it is||
1397|204|N|against the law.||
1397|205|N|   Lab and/or medical tests (such as PSA, cholesterol,||
1397|206|N|hemoglobin/hematocrit, testosterone blood levels, prostate exams)||
1397|207|N|should be done while you are using this medication. Keep all||
1397|208|N|medical and lab appointments. Consult your doctor for more||
1397|209|N|details.||
1397|210|N|   This medication has been prescribed for your current condition||
1397|211|N|only. Do not use it later for another problem unless your doctor||
1397|212|N|directs you to do so. A different medication may be necessary in||
1397|213|N|that case.||
1397|214|B|||
1397|215|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1397|216|D|If it is near the time of the next dose, skip the missed dose.||
1397|217|D|Use your next dose at the regular time. Do not double the dose to||
1397|218|D|catch up.||
1397|219|B|||
1397|220|R|STORAGE:  Store at room temperature. Do not store near an open||
1397|221|R|flame. Do not freeze. Discard used pumps in a secure trash can.||
1397|222|R|Keep all medications away from children and pets.||
1397|223|R|   Do not flush medications down the toilet or pour them into a||
1397|224|R|drain unless instructed to do so. Properly discard this product||
1397|225|R|when it is expired or no longer needed. Consult your pharmacist||
1397|226|R|or local waste disposal company.||
1397|227|B|||
1397|228|A|Information last revised July 2025.||
1397|229|A|Copyright(c) 2025 First Databank, Inc.||
1397|230|B|||
1399|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1399|002|Z|does NOT have all possible information about this product. This||
1399|003|Z|information does not assure that this product is safe, effective,||
1399|004|Z|or appropriate for you. This information is not individual||
1399|005|Z|medical advice and does not substitute for the advice of your||
1399|006|Z|health care professional. Always ask your health care||
1399|007|Z|professional for complete information about this product and your||
1399|008|Z|specific health needs.||
1399|009|B|||
1399|010|T|ROFLUMILAST - ORAL||
1399|011|F|(roe-FLUE-mi-last)||
1399|012|B|||
1399|013|C|COMMON BRAND NAME(S): Daliresp||
1399|014|B|||
1399|015|U|USES:  Roflumilast is used to control and prevent symptoms||
1399|016|U|(wheezing and shortness of breath) caused by ongoing lung disease||
1399|017|U|(chronic obstructive pulmonary disease-COPD which includes||
1399|018|U|bronchitis). It should be used along with other medications||
1399|019|U|(bronchodilators such as salmeterol, ipratropium) to treat COPD.||
1399|020|U|It works by reducing the irritation and swelling of the airways.||
1399|021|U|Controlling symptoms of breathing problems can decrease time lost||
1399|022|U|from work or school.||
1399|023|U|   This medication must be used regularly to be effective. It||
1399|024|U|does not work right away and should not be used to relieve sudden||
1399|025|U|shortness of breath or wheezing. If sudden breathing problems||
1399|026|U|occur, use your quick-relief inhaler (such as albuterol, also||
1399|027|U|called salbutamol in some countries) as prescribed.||
1399|028|B|||
1399|029|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1399|030|H|Patient Information Leaflet from your pharmacist before you start||
1399|031|H|taking roflumilast and each time you get a refill. If you have||
1399|032|H|any questions, ask your doctor or pharmacist.||
1399|033|H|   Take this medication by mouth with or without food as directed||
1399|034|H|by your doctor, usually once daily.||
1399|035|H|   Use this medication regularly in order to get the most benefit||
1399|036|H|from it. This medication works best if used at evenly spaced||
1399|037|H|intervals. To help you remember, use it at the same time each||
1399|038|H|day. Do not increase your dose, use this medication more often,||
1399|039|H|or stop using it without first consulting your doctor.||
1399|040|H|   Tell your doctor if your condition does not get better or if||
1399|041|H|it gets worse.||
1399|042|B|||
1399|043|S|SIDE EFFECTS:  Diarrhea, weight loss, stomach/abdominal pain,||
1399|044|S|nausea, loss of appetite, headache, or dizziness may occur. If||
1399|045|S|any of these effects last or get worse, tell your doctor or||
1399|046|S|pharmacist promptly.||
1399|047|S|   Check your weight regularly while taking this medication. Tell||
1399|048|S|your doctor right away of any unusual or extreme weight loss.||
1399|049|S|   Remember that this medication has been prescribed because your||
1399|050|S|doctor has judged that the benefit to you is greater than the||
1399|051|S|risk of side effects. Many people using this medication do not||
1399|052|S|have serious side effects.||
1399|053|S|   Tell your doctor right away if you have any serious side||
1399|054|S|effects, including: mental/mood changes (such as nervousness,||
1399|055|S|depression, thoughts of suicide), trouble sleeping, shaking||
1399|056|S|(tremors), fast/irregular heartbeat.||
1399|057|S|   A very serious allergic reaction to this product is rare.||
1399|058|S|However, get medical help right away if you notice any symptoms||
1399|059|S|of a serious allergic reaction, including: rash, itching/swelling||
1399|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1399|061|S|breathing.||
1399|062|S|   This is not a complete list of possible side effects. If you||
1399|063|S|notice other effects not listed above, contact your doctor or||
1399|064|S|pharmacist.||
1399|065|S|   In the US -||
1399|066|S|   Call your doctor for medical advice about side effects. You||
1399|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1399|068|S|www.fda.gov/medwatch.||
1399|069|S|   In Canada - Call your doctor for medical advice about side||
1399|070|S|effects. You may report side effects to Health Canada at||
1399|071|S|1-866-234-2345.||
1399|072|B|||
1399|073|P|PRECAUTIONS:  Before taking roflumilast, tell your doctor or||
1399|074|P|pharmacist if you are allergic to it; or if you have any other||
1399|075|P|allergies. This product may contain inactive ingredients, which||
1399|076|P|can cause allergic reactions or other problems. Talk to your||
1399|077|P|pharmacist for more details.||
1399|078|P|   Before using this medication, tell your doctor or pharmacist||
1399|079|P|your medical history, especially of: liver disease, cancer, heart||
1399|080|P|disease (such as heart failure), current/past infections (such as||
1399|081|P|tuberculosis, herpes), mental/mood disorders (depression,||
1399|082|P|thoughts of suicide), unexplained/extreme weight loss, immune||
1399|083|P|system disorders (such as lupus, HIV).||
1399|084|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1399|085|P|can make you more dizzy. Do not drive, use machinery, or do||
1399|086|P|anything that needs alertness until you can do it safely. Limit||
1399|087|P|alcoholic beverages. Talk to your doctor if you are using||
1399|088|P|marijuana (cannabis).||
1399|089|P|   Before having surgery, tell your doctor or dentist about all||
1399|090|P|the products you use (including prescription drugs,||
1399|091|P|nonprescription drugs, and herbal products).||
1399|092|P|   During pregnancy, this medication should be used only when||
1399|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
1399|094|P|   It is unknown if this medication passes into breast milk.||
1399|095|P|Consult your doctor before breastfeeding.||
1399|096|B|||
1399|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1399|098|I|medications work or increase your risk for serious side effects.||
1399|099|I|This document does not contain all possible drug interactions.||
1399|100|I|Keep a list of all the products you use (including||
1399|101|I|prescription/nonprescription drugs and herbal products) and share||
1399|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
1399|103|I|the dosage of any medicines without your doctor's approval.||
1399|104|I|   Some medications can affect the removal of roflumilast from||
1399|105|I|your body, which may affect how this product works. Examples||
1399|106|I|include rifamycins (such as rifampicin), drugs used to treat||
1399|107|I|seizures (such as carbamazepine, phenytoin), among others.||
1399|108|B|||
1399|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1399|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1399|111|O|poison control center right away. US residents can call||
1399|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1399|113|O|Symptoms of overdose may include: severe dizziness, fast/pounding||
1399|114|O|heartbeat.||
1399|115|B|||
1399|116|N|NOTES:  Do not share this medication with others.||
1399|117|N|   Lab and/or medical tests (such as lung function, weight) may||
1399|118|N|be done while you are taking this medication. Keep all medical||
1399|119|N|and lab appointments. Consult your doctor for more details.||
1399|120|B|||
1399|121|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1399|122|D|remember. If it is near the time of the next dose, skip the||
1399|123|D|missed dose. Take your next dose at the regular time. Do not||
1399|124|D|double the dose to catch up.||
1399|125|B|||
1399|126|R|STORAGE:  Store at room temperature away from light and moisture.||
1399|127|R|Do not store in the bathroom. Keep all medications away from||
1399|128|R|children and pets.||
1399|129|R|   Do not flush medications down the toilet or pour them into a||
1399|130|R|drain unless instructed to do so. Properly discard this product||
1399|131|R|when it is expired or no longer needed. Consult your pharmacist||
1399|132|R|or local waste disposal company.||
1399|133|B|||
1399|134|A|Information last revised October 2024.||
1399|135|A|Copyright(c) 2025 First Databank, Inc.||
1399|136|B|||
1401|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1401|002|Z|does NOT have all possible information about this product. This||
1401|003|Z|information does not assure that this product is safe, effective,||
1401|004|Z|or appropriate for you. This information is not individual||
1401|005|Z|medical advice and does not substitute for the advice of your||
1401|006|Z|health care professional. Always ask your health care||
1401|007|Z|professional for complete information about this product and your||
1401|008|Z|specific health needs.||
1401|009|B|||
1401|010|T|TENOFOVIR POWDER - ORAL||
1401|011|F|(ten-OF-oh-vir)||
1401|012|B|||
1401|013|C|COMMON BRAND NAME(S): Viread||
1401|014|B|||
1401|015|W|WARNING:  If you have hepatitis B infection, your hepatitis||
1401|016|W|symptoms may get worse or become very serious if you stop taking||
1401|017|W|tenofovir. Talk with your doctor before stopping this medication.||
1401|018|W|Your doctor will monitor liver tests for several months after you||
1401|019|W|stop tenofovir. Tell your doctor right away if you develop||
1401|020|W|symptoms of worsening liver problems.||
1401|021|B|||
1401|022|U|USES:  This drug is used with other HIV medications to help||
1401|023|U|control HIV infection. It helps to decrease the amount of HIV in||
1401|024|U|your body so your immune system can work better. This lowers your||
1401|025|U|chance of getting HIV complications (such as new infections,||
1401|026|U|cancer) and improves your quality of life. Tenofovir belongs to a||
1401|027|U|class of drugs known as nucleotide reverse transcriptase||
1401|028|U|inhibitors (NRTIs).||
1401|029|U|   Tenofovir is not a cure for HIV infection. To decrease your||
1401|030|U|risk of spreading HIV disease to others, continue to take all HIV||
1401|031|U|medications exactly as prescribed by your doctor. Use an||
1401|032|U|effective barrier method (latex or polyurethane condoms/dental||
1401|033|U|dams) during sexual activity as directed by your doctor. Do not||
1401|034|U|share personal items (such as needles/syringes, toothbrushes, and||
1401|035|U|razors) that may have contacted blood or other body fluids.||
1401|036|U|Consult your doctor or pharmacist for more details.||
1401|037|U|   Tenofovir is also used to treat a certain type of liver||
1401|038|U|infection called chronic hepatitis B infection. It helps to||
1401|039|U|decrease the amount of hepatitis B virus in your body by||
1401|040|U|interfering with virus growth.||
1401|041|B|||
1401|042|V|OTHER USES:  This section contains uses of this drug that are not||
1401|043|V|listed in the approved professional labeling for the drug but||
1401|044|V|that may be prescribed by your health care professional. Use this||
1401|045|V|drug for a condition that is listed in this section only if it||
1401|046|V|has been so prescribed by your health care professional.||
1401|047|V|   This product may also be used to lessen the risk of HIV||
1401|048|V|infection after contact with the virus (for example, due to a||
1401|049|V|needle stick). Ask your doctor for more details.||
1401|050|B|||
1401|051|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1401|052|H|from your pharmacist before you start taking tenofovir and each||
1401|053|H|time you get a refill. If you have any questions, ask your doctor||
1401|054|H|or pharmacist.||
1401|055|H|   Take this medication by mouth with food as directed by your||
1401|056|H|doctor, usually once daily. The dosage is based on your medical||
1401|057|H|condition and response to treatment. Children's dosage is also||
1401|058|H|based on weight.||
1401|059|H|   Carefully measure the dose using the special measuring||
1401|060|H|device/scoop provided. Do not use a household spoon because you||
1401|061|H|may not get the correct dose. Mix tenofovir with 2 to 4 ounces||
1401|062|H|(60 to 120 milliliters) of soft foods that can be swallowed||
1401|063|H|without chewing (such as applesauce, baby food, yogurt). Do not||
1401|064|H|mix tenofovir with liquid as this medication may float to the top||
1401|065|H|of the liquid even after stirring. Take this medication right||
1401|066|H|away after mixing to avoid bitter taste.||
1401|067|H|   It is very important to keep taking this medication (and other||
1401|068|H|HIV medications) exactly as prescribed by your doctor. Do not||
1401|069|H|skip any doses. Do not increase your dose, take this drug more||
1401|070|H|often than prescribed, or stop taking it (or other HIV||
1401|071|H|medications) even for a short time unless directed to do so by||
1401|072|H|your doctor. Skipping or changing your dose without approval from||
1401|073|H|your doctor may cause the amount of virus to increase, make the||
1401|074|H|infection more difficult to treat (resistant), or worsen side||
1401|075|H|effects.||
1401|076|H|   For the best effect, take this medication at evenly spaced||
1401|077|H|times. To help you remember, take this medication at the same||
1401|078|H|time every day.||
1401|079|B|||
1401|080|S|SIDE EFFECTS:  Dizziness, diarrhea, or trouble sleeping may||
1401|081|S|occur. If any of these effects last or get worse, tell your||
1401|082|S|doctor or pharmacist promptly.||
1401|083|S|   Remember that this medication has been prescribed because your||
1401|084|S|doctor has judged that the benefit to you is greater than the||
1401|085|S|risk of side effects. Many people using this medication do not||
1401|086|S|have serious side effects.||
1401|087|S|   Tell your doctor right away if you have any serious side||
1401|088|S|effects, including: mental/mood changes (such as depression,||
1401|089|S|anxiety, confusion), signs of kidney problems (such as a change||
1401|090|S|in the amount of urine), unusual thirst, muscle cramps/weakness.||
1401|091|S|   As your immune system gets stronger with HIV treatment, it can||
1401|092|S|begin to fight off infections you already had, possibly causing||
1401|093|S|disease symptoms to come back. You could also have symptoms if||
1401|094|S|your immune system becomes overactive. This reaction may happen||
1401|095|S|at any time (soon after starting HIV treatment or many months||
1401|096|S|later). Tell your doctor right away if you have any serious||
1401|097|S|symptoms, including: unexplained weight loss, severe tiredness,||
1401|098|S|muscle aches/weakness that doesn't go away, headaches that are||
1401|099|S|severe or don't go away, joint pain, numbness/tingling of the||
1401|100|S|hands/feet/arms/legs, vision changes, signs of infection (such as||
1401|101|S|sore throat the doesn't go away, fever, chills, swollen lymph||
1401|102|S|nodes, non-healing skin sores), signs of an overactive thyroid||
1401|103|S|(such as irritability, nervousness, heat intolerance,||
1401|104|S|fast/pounding/irregular heartbeat).||
1401|105|S|   Rarely, this medication can cause severe (sometimes fatal)||
1401|106|S|liver and blood problems (lactic acidosis). Tell your doctor||
1401|107|S|right away if you develop symptoms of liver problems (such as||
1401|108|S|nausea/vomiting that doesn't stop, loss of appetite,||
1401|109|S|stomach/abdominal pain, yellowing eyes/skin, dark urine) or||
1401|110|S|lactic acidosis (such as deep/rapid breathing, drowsiness,||
1401|111|S|nausea/vomiting, unusual weakness).||
1401|112|S|   Tenofovir may increase the risk of bone loss. Discuss the||
1401|113|S|risks and benefits of treatment with your doctor, as well as the||
1401|114|S|possible use of calcium and vitamin D to reduce this side effect.||
1401|115|S|If you are at risk for bone loss, your doctor may monitor your||
1401|116|S|bone mineral density. Tell your doctor right away if any of the||
1401|117|S|following serious side effects occur: bone pain, easily broken||
1401|118|S|bones.||
1401|119|S|   Tenofovir can commonly cause a rash that is usually not||
1401|120|S|serious. However, you may not be able to tell it apart from a||
1401|121|S|rare rash that could be a sign of a severe reaction. Get medical||
1401|122|S|help right away if you develop any rash.||
1401|123|S|   A very serious allergic reaction to this drug is rare.||
1401|124|S|However, get medical help right away if you notice any symptoms||
1401|125|S|of a serious allergic reaction, including: rash, itching/swelling||
1401|126|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1401|127|S|breathing.||
1401|128|S|   This is not a complete list of possible side effects. If you||
1401|129|S|notice other effects not listed above, contact your doctor or||
1401|130|S|pharmacist.||
1401|131|S|   In the US -||
1401|132|S|   Call your doctor for medical advice about side effects. You||
1401|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1401|134|S|www.fda.gov/medwatch.||
1401|135|S|   In Canada - Call your doctor for medical advice about side||
1401|136|S|effects. You may report side effects to Health Canada at||
1401|137|S|1-866-234-2345.||
1401|138|B|||
1401|139|P|PRECAUTIONS:  Before taking tenofovir, tell your doctor or||
1401|140|P|pharmacist if you are allergic to it; or if you have any other||
1401|141|P|allergies. This product may contain inactive ingredients, which||
1401|142|P|can cause allergic reactions or other problems. Talk to your||
1401|143|P|pharmacist for more details.||
1401|144|P|   Before using this medication, tell your doctor or pharmacist||
1401|145|P|your medical history, especially of: kidney problems, liver||
1401|146|P|problems (such as hepatitis C, cirrhosis), bone problems (such as||
1401|147|P|bone disease, bone loss/osteoporosis, weak/broken bones), disease||
1401|148|P|of the pancreas (pancreatitis), alcohol use.||
1401|149|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1401|150|P|can make you more dizzy. Do not drive, use machinery, or do||
1401|151|P|anything that needs alertness until you can do it safely. Limit||
1401|152|P|alcoholic beverages. Talk to your doctor if you are using||
1401|153|P|marijuana (cannabis). Also limit alcohol because it may increase||
1401|154|P|your risk of liver problems and pancreatitis.||
1401|155|P|   Before having surgery, tell your doctor or dentist about all||
1401|156|P|the products you use (including prescription drugs,||
1401|157|P|nonprescription drugs, and herbal products).||
1401|158|P|   During pregnancy, this medication should be used only when||
1401|159|P|clearly needed. Discuss the risks and benefits with your doctor.||
1401|160|P|If you have HIV infection, treatment can lower the risk of||
1401|161|P|passing HIV infection to your baby, and tenofovir may be part of||
1401|162|P|that treatment.||
1401|163|P|   This medication passes into breast milk, but is unlikely to||
1401|164|P|harm a nursing infant. If you have HIV, breast milk may transmit||
1401|165|P|HIV. Consult your doctor before breastfeeding.||
1401|166|B|||
1401|167|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1401|168|I|medications work or increase your risk for serious side effects.||
1401|169|I|This document does not contain all possible drug interactions.||
1401|170|I|Keep a list of all the products you use (including||
1401|171|I|prescription/nonprescription drugs and herbal products) and share||
1401|172|I|it with your doctor and pharmacist. Do not start, stop, or change||
1401|173|I|the dosage of any medicines without your doctor's approval.||
1401|174|I|   Some products that may interact with this drug include:||
1401|175|I|adefovir, orlistat, other drugs that may harm the kidneys||
1401|176|I|(including aminoglycosides such as amikacin/gentamicin).||
1401|177|I|   Do not take this medication with other products that contain||
1401|178|I|tenofovir.||
1401|179|I|   Some other drugs to treat HIV infection (including atazanavir)||
1401|180|I|may also interact with tenofovir. Tenofovir can decrease the||
1401|181|I|effectiveness of atazanavir (by decreasing blood levels). If you||
1401|182|I|are taking atazanavir with this product, you may need to also||
1401|183|I|take another medication (ritonavir). Consult your doctor or||
1401|184|I|pharmacist for more details. Your doctor will adjust your||
1401|185|I|medications and monitor your treatment to reduce the risk of side||
1401|186|I|effects.||
1401|187|B|||
1401|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1401|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1401|190|O|poison control center right away. US residents can call||
1401|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1401|192|B|||
1401|193|N|NOTES:  Do not share this medication with others.||
1401|194|N|   Lab and/or medical tests (such as kidney/liver function, urine||
1401|195|N|glucose/protein, viral load, T-cell counts, blood mineral levels,||
1401|196|N|bone density tests) should be done before you start taking this||
1401|197|N|medication and while you are taking it. Keep all medical and lab||
1401|198|N|appointments. Consult your doctor for more details.||
1401|199|B|||
1401|200|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1401|201|D|remember. If it is near the time of the next dose, skip the||
1401|202|D|missed dose. Take your next dose at the regular time. Do not||
1401|203|D|double the dose to catch up.||
1401|204|B|||
1401|205|R|STORAGE:  Store in the original container at room temperature||
1401|206|R|away from light and moisture. Do not store in the bathroom. Keep||
1401|207|R|all medications away from children and pets.||
1401|208|R|   Do not flush medications down the toilet or pour them into a||
1401|209|R|drain unless instructed to do so. Properly discard this product||
1401|210|R|when it is expired or no longer needed. Consult your pharmacist||
1401|211|R|or local waste disposal company.||
1401|212|B|||
1401|213|A|Information last revised April 2025.||
1401|214|A|Copyright(c) 2025 First Databank, Inc.||
1401|215|B|||
1402|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1402|002|Z|does NOT have all possible information about this product. This||
1402|003|Z|information does not assure that this product is safe, effective,||
1402|004|Z|or appropriate for you. This information is not individual||
1402|005|Z|medical advice and does not substitute for the advice of your||
1402|006|Z|health care professional. Always ask your health care||
1402|007|Z|professional for complete information about this product and your||
1402|008|Z|specific health needs.||
1402|009|B|||
1402|010|T|AZILSARTAN - ORAL||
1402|011|F|(AY-zil-SAR-tan)||
1402|012|B|||
1402|013|C|COMMON BRAND NAME(S): Edarbi||
1402|014|B|||
1402|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
1402|016|W|unborn baby if used during pregnancy. It is important to prevent||
1402|017|W|pregnancy while taking this medication. Consult your doctor for||
1402|018|W|more details and to discuss the use of reliable forms of birth||
1402|019|W|control while taking this medication. If you are planning||
1402|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
1402|021|W|your doctor right away.||
1402|022|B|||
1402|023|U|USES:  Azilsartan is used to treat high blood pressure||
1402|024|U|(hypertension). Lowering high blood pressure helps prevent||
1402|025|U|strokes, heart attacks, and kidney problems. Azilsartan belongs||
1402|026|U|to a class of drugs called angiotensin receptor blockers (ARBs).||
1402|027|U|It works by relaxing blood vessels so that blood can flow more||
1402|028|U|easily.||
1402|029|B|||
1402|030|V|OTHER USES:  This section contains uses of this drug that are not||
1402|031|V|listed in the approved professional labeling for the drug but||
1402|032|V|that may be prescribed by your health care professional. Use this||
1402|033|V|drug for a condition that is listed in this section only if it||
1402|034|V|has been so prescribed by your health care professional.||
1402|035|V|   This medication may also be used for kidney disease and to||
1402|036|V|help protect the kidneys from harm due to diabetes.||
1402|037|B|||
1402|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1402|039|H|from your pharmacist before you start taking azilsartan and each||
1402|040|H|time you get a refill. If you have any questions, ask your doctor||
1402|041|H|or pharmacist.||
1402|042|H|   Take this medication by mouth with or without food as directed||
1402|043|H|by your doctor, usually once daily. The dosage is based on your||
1402|044|H|medical condition and response to treatment.||
1402|045|H|   Use this medication regularly to get the most benefit from it.||
1402|046|H|To help you remember, take it at the same time each day. Keep||
1402|047|H|taking this medication even if you feel well. Most people with||
1402|048|H|high blood pressure do not feel sick.||
1402|049|H|   Tell your doctor if your condition does not get better or if||
1402|050|H|it gets worse (your blood pressure readings remain high or||
1402|051|H|increase).||
1402|052|B|||
1402|053|S|SIDE EFFECTS:  Dizziness, diarrhea, or tiredness may occur. If||
1402|054|S|any of these effects last or get worse, tell your doctor or||
1402|055|S|pharmacist promptly.||
1402|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
1402|057|S|slowly when rising from a sitting or lying position.||
1402|058|S|   Remember that this medication has been prescribed because your||
1402|059|S|doctor has judged that the benefit to you is greater than the||
1402|060|S|risk of side effects. Many people using this medication do not||
1402|061|S|have serious side effects.||
1402|062|S|   Tell your doctor right away if you have any serious side||
1402|063|S|effects, including: muscle spasms, symptoms of a high potassium||
1402|064|S|blood level (such as muscle weakness, slow/irregular heartbeat).||
1402|065|S|   Although azilsartan may be used to prevent kidney problems or||
1402|066|S|treat people who have kidney problems, it may also rarely cause||
1402|067|S|serious kidney problems or make them worse. Your doctor will||
1402|068|S|check your kidney function while you are taking azilsartan. Tell||
1402|069|S|your doctor right away if you have any signs of kidney problems||
1402|070|S|such as a change in the amount of urine.||
1402|071|S|   A very serious allergic reaction to this drug is rare.||
1402|072|S|However, get medical help right away if you notice any symptoms||
1402|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1402|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1402|075|S|breathing.||
1402|076|S|   This is not a complete list of possible side effects. If you||
1402|077|S|notice other effects not listed above, contact your doctor or||
1402|078|S|pharmacist.||
1402|079|S|   In the US -||
1402|080|S|   Call your doctor for medical advice about side effects. You||
1402|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1402|082|S|www.fda.gov/medwatch.||
1402|083|S|   In Canada - Call your doctor for medical advice about side||
1402|084|S|effects. You may report side effects to Health Canada at||
1402|085|S|1-866-234-2345.||
1402|086|B|||
1402|087|P|PRECAUTIONS:  Before taking azilsartan, tell your doctor or||
1402|088|P|pharmacist if you are allergic to it; or if you have any other||
1402|089|P|allergies. This product may contain inactive ingredients, which||
1402|090|P|can cause allergic reactions or other problems. Talk to your||
1402|091|P|pharmacist for more details.||
1402|092|P|   Before using this medication, tell your doctor or pharmacist||
1402|093|P|your medical history, especially of: dehydration, high level of||
1402|094|P|potassium in the blood.||
1402|095|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1402|096|P|can make you more dizzy. Do not drive, use machinery, or do||
1402|097|P|anything that needs alertness until you can do it safely. Limit||
1402|098|P|alcoholic beverages. Talk to your doctor if you are using||
1402|099|P|marijuana (cannabis).||
1402|100|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1402|101|P|and cause you to feel lightheaded. Tell your doctor if you have||
1402|102|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1402|103|P|of fluids unless your doctor tells you not to.||
1402|104|P|   This medication may increase your potassium levels. Before||
1402|105|P|using potassium supplements or salt substitutes that contain||
1402|106|P|potassium, consult your doctor or pharmacist.||
1402|107|P|   Before having surgery, tell your doctor or dentist about all||
1402|108|P|the products you use (including prescription drugs,||
1402|109|P|nonprescription drugs, and herbal products).||
1402|110|P|   Older adults may be more sensitive to the side effects of this||
1402|111|P|drug, including dizziness and change in the amount of urine||
1402|112|P|(kidney problems).||
1402|113|P|   Tell your doctor if you are pregnant or plan to become||
1402|114|P|pregnant. You should not become pregnant while using azilsartan.||
1402|115|P|Azilsartan may harm an unborn baby. If you become pregnant, talk||
1402|116|P|to your doctor right away about the risks and benefits of this||
1402|117|P|medication. (See also Warning section.)||
1402|118|P|   It is unknown if this drug passes into breast milk. Consult||
1402|119|P|your doctor before breastfeeding.||
1402|120|B|||
1402|121|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
1402|122|I|   Drug interactions may change how your medications work or||
1402|123|I|increase your risk for serious side effects. This document does||
1402|124|I|not contain all possible drug interactions. Keep a list of all||
1402|125|I|the products you use (including prescription/nonprescription||
1402|126|I|drugs and herbal products) and share it with your doctor and||
1402|127|I|pharmacist. Do not start, stop, or change the dosage of any||
1402|128|I|medicines without your doctor's approval.||
1402|129|I|   Some products that may interact with this drug include:||
1402|130|I|aliskiren, lithium, drugs that may increase the level of||
1402|131|I|potassium in the blood (such as sparsentan, ACE inhibitors||
1402|132|I|including benazepril/lisinopril, birth control pills containing||
1402|133|I|drospirenone).||
1402|134|I|   Some products have ingredients that could raise your blood||
1402|135|I|pressure. Tell your pharmacist what products you are using, and||
1402|136|I|ask how to use them safely (especially cough-and-cold products,||
1402|137|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1402|138|B|||
1402|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1402|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1402|141|O|poison control center right away. US residents can call||
1402|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1402|143|B|||
1402|144|N|NOTES:  Do not share this medication with others.||
1402|145|N|   Lifestyle changes such as stress reduction programs, exercise,||
1402|146|N|and dietary changes may increase the effectiveness of this||
1402|147|N|medicine. Talk to your doctor or pharmacist about lifestyle||
1402|148|N|changes that might benefit you.||
1402|149|N|   Lab and/or medical tests (such as kidney function, potassium||
1402|150|N|levels) should be done while you are taking this medication. Keep||
1402|151|N|all medical and lab appointments. Consult your doctor for more||
1402|152|N|details.||
1402|153|N|   Have your blood pressure checked regularly while taking this||
1402|154|N|medication. Learn how to monitor your own blood pressure, and||
1402|155|N|share the results with your doctor.||
1402|156|B|||
1402|157|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1402|158|D|remember. If it is near the time of the next dose, skip the||
1402|159|D|missed dose. Take your next dose at the regular time. Do not||
1402|160|D|double the dose to catch up.||
1402|161|B|||
1402|162|R|STORAGE:  Store in the original container at room temperature||
1402|163|R|away from light and moisture. Do not store in the bathroom. Keep||
1402|164|R|all medications away from children and pets.||
1402|165|R|   Do not flush medications down the toilet or pour them into a||
1402|166|R|drain unless instructed to do so. Properly discard this product||
1402|167|R|when it is expired or no longer needed. Consult your pharmacist||
1402|168|R|or local waste disposal company.||
1402|169|B|||
1402|170|A|Information last revised July 2024.||
1402|171|A|Copyright(c) 2025 First Databank, Inc.||
1402|172|B|||
1403|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1403|002|Z|does NOT have all possible information about this product. This||
1403|003|Z|information does not assure that this product is safe, effective,||
1403|004|Z|or appropriate for you. This information is not individual||
1403|005|Z|medical advice and does not substitute for the advice of your||
1403|006|Z|health care professional. Always ask your health care||
1403|007|Z|professional for complete information about this product and your||
1403|008|Z|specific health needs.||
1403|009|B|||
1403|010|T|BELIMUMAB - INJECTION||
1403|011|F|(be-LIM-ue-mab)||
1403|012|B|||
1403|013|C|COMMON BRAND NAME(S): Benlysta||
1403|014|B|||
1403|015|U|USES:  This medication is used with other medications to treat||
1403|016|U|certain types of lupus. Belimumab belongs to a class of drugs||
1403|017|U|known as monoclonal antibodies. It works by decreasing the effect||
1403|018|U|of a certain protein that is increased in people with active||
1403|019|U|lupus. This may help decrease some of the symptoms of lupus.||
1403|020|B|||
1403|021|H|HOW TO USE:  Read the Medication Guide provided by your||
1403|022|H|pharmacist before you start using belimumab and each time you get||
1403|023|H|a treatment. If you have any questions, ask your doctor or||
1403|024|H|pharmacist.||
1403|025|H|   This medication is given by injection into a vein over 1 hour||
1403|026|H|by a health care professional. It is given as directed by your||
1403|027|H|doctor, usually every 2 weeks for the first 3 doses, then every 4||
1403|028|H|weeks thereafter. The dosage is based on your weight.||
1403|029|H|   Infusion reactions may happen during or after the infusion of||
1403|030|H|this drug. Your doctor may prescribe other medications before||
1403|031|H|each treatment to help prevent these side effects. Tell your||
1403|032|H|doctor right away if you have any symptoms of infusion reactions||
1403|033|H|such as headache, slow heartbeat, muscle pain,||
1403|034|H|dizziness/fainting, or nausea. Your doctor may give you other||
1403|035|H|medications to help with these side effects or may slow down or||
1403|036|H|stop your treatment for some time.||
1403|037|H|   Use this medication regularly to get the most benefit from it.||
1403|038|H|To help you remember, mark your calendar with a reminder.||
1403|039|H|   Tell your doctor if your condition does not get better or if||
1403|040|H|it gets worse.||
1403|041|B|||
1403|042|S|SIDE EFFECTS:  See also How to Use section.||
1403|043|S|   Nausea, diarrhea, or trouble sleeping may occur. If any of||
1403|044|S|these effects last or get worse, tell your doctor or pharmacist||
1403|045|S|promptly.||
1403|046|S|   Remember that this medication has been prescribed because your||
1403|047|S|doctor has judged that the benefit to you is greater than the||
1403|048|S|risk of side effects. Many people using this medication do not||
1403|049|S|have serious side effects.||
1403|050|S|   Tell your doctor right away if you have any serious side||
1403|051|S|effects, including: mental/mood changes (such as new/worsening||
1403|052|S|depression, thoughts of suicide).||
1403|053|S|   This medication may lower your ability to fight infections.||
1403|054|S|This may make you more likely to get a serious (rarely fatal)||
1403|055|S|infection or make any infection you have worse. Tell your doctor||
1403|056|S|right away if you have any signs of infection (such as sore||
1403|057|S|throat that doesn't go away, fever, chills).||
1403|058|S|   Very rarely, people using this medication have developed||
1403|059|S|cancers (including skin cancer). Tell your doctor right away if||
1403|060|S|you develop symptoms such as a new skin lesion or bump, change in||
1403|061|S|size or color of a mole, night sweats, swollen lymph nodes, or||
1403|062|S|unexplained weight loss.||
1403|063|S|   This medication may increase your risk of getting a rare but||
1403|064|S|very serious (possibly fatal) brain infection (progressive||
1403|065|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1403|066|S|if you have any of these side effects: clumsiness, loss of||
1403|067|S|coordination/balance, weakness, sudden change in your thinking||
1403|068|S|(such as confusion, difficulty concentrating, memory loss),||
1403|069|S|difficulty talking/walking, seizure, vision changes.||
1403|070|S|   Get medical help right away if you have any very serious side||
1403|071|S|effects, including: heart problems (such as chest/jaw/left arm||
1403|072|S|pain, shortness of breath, unusual sweating).||
1403|073|S|   A very serious allergic reaction to this drug is rare.||
1403|074|S|However, get medical help right away if you notice any symptoms||
1403|075|S|of a serious allergic reaction, including: rash, itching/swelling||
1403|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1403|077|S|breathing.||
1403|078|S|   This is not a complete list of possible side effects. If you||
1403|079|S|notice other effects not listed above, contact your doctor or||
1403|080|S|pharmacist.||
1403|081|S|   In the US -||
1403|082|S|   Call your doctor for medical advice about side effects. You||
1403|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1403|084|S|www.fda.gov/medwatch.||
1403|085|S|   In Canada - Call your doctor for medical advice about side||
1403|086|S|effects. You may report side effects to Health Canada at||
1403|087|S|1-866-234-2345.||
1403|088|B|||
1403|089|P|PRECAUTIONS:  Before using belimumab, tell your doctor or||
1403|090|P|pharmacist if you are allergic to it; or if you have any other||
1403|091|P|allergies. This product may contain inactive ingredients, which||
1403|092|P|can cause allergic reactions or other problems. Talk to your||
1403|093|P|pharmacist for more details.||
1403|094|P|   Before using this medication, tell your doctor or pharmacist||
1403|095|P|your medical history, especially of: infections (current||
1403|096|P|infections, infections that return), mental/mood problems (such||
1403|097|P|as depression, thoughts of suicide), cancer.||
1403|098|P|   Belimumab can make you more likely to get infections or may||
1403|099|P|make current infections worse. Stay away from anyone who has an||
1403|100|P|infection that may easily spread (such as chickenpox, COVID-19,||
1403|101|P|measles, flu). Talk to your doctor if you have been exposed to an||
1403|102|P|infection or for more details.||
1403|103|P|   Tell your doctor your vaccine history and ask if you need to||
1403|104|P|get any vaccines before starting treatment with this medication.||
1403|105|P|Tell your health care professional that you are using belimumab||
1403|106|P|before having any immunizations/vaccinations. Avoid contact with||
1403|107|P|people who have recently received live vaccines (such as flu||
1403|108|P|vaccine inhaled through the nose).||
1403|109|P|   Before having surgery, tell your doctor or dentist about all||
1403|110|P|the products you use (including prescription drugs,||
1403|111|P|nonprescription drugs, and herbal products).||
1403|112|P|   During pregnancy, this medication should be used only when||
1403|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
1403|114|P|   This drug passes into breast milk. Consult your doctor before||
1403|115|P|breastfeeding.||
1403|116|B|||
1403|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1403|118|I|medications work or increase your risk for serious side effects.||
1403|119|I|This document does not contain all possible drug interactions.||
1403|120|I|Keep a list of all the products you use (including||
1403|121|I|prescription/nonprescription drugs and herbal products) and share||
1403|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
1403|123|I|the dosage of any medicines without your doctor's approval.||
1403|124|I|   Some products that may interact with this drug include: other||
1403|125|I|drugs that weaken the immune system/increase the risk of||
1403|126|I|infection (such as natalizumab, rituximab).||
1403|127|B|||
1403|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1403|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1403|130|O|poison control center right away. US residents can call||
1403|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1403|132|B|||
1403|133|N|NOTES:  Lab and/or medical tests may be done while you are using||
1403|134|N|this medication. Keep all medical and lab appointments. Consult||
1403|135|N|your doctor for more details.||
1403|136|B|||
1403|137|D|MISSED DOSE:  It is important to get each dose of this medication||
1403|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1403|139|D|right away for a new dosing schedule.||
1403|140|B|||
1403|141|R|STORAGE:  Not applicable. This medication is given in a clinic||
1403|142|R|and will not be stored at home.||
1403|143|B|||
1403|144|M|MEDICAL ALERT:  Your condition can cause complications in a||
1403|145|M|medical emergency. For information about enrolling in MedicAlert,||
1403|146|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1403|147|B|||
1403|148|A|Information last revised May 2025.||
1403|149|A|Copyright(c) 2025 First Databank, Inc.||
1403|150|B|||
1404|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1404|002|Z|does NOT have all possible information about this product. This||
1404|003|Z|information does not assure that this product is safe, effective,||
1404|004|Z|or appropriate for you. This information is not individual||
1404|005|Z|medical advice and does not substitute for the advice of your||
1404|006|Z|health care professional. Always ask your health care||
1404|007|Z|professional for complete information about this product and your||
1404|008|Z|specific health needs.||
1404|009|B|||
1404|010|T|TESTOSTERONE SOLUTION - TRANSDERMAL||
1404|011|F|(tes-TOS-ter-one)||
1404|012|B|||
1404|013|C|COMMON BRAND NAME(S): Axiron||
1404|014|B|||
1404|015|W|WARNING:  Children accidentally exposed to this medication by||
1404|016|W|direct contact with someone using it may absorb this drug through||
1404|017|W|their skin. If this occurs, the child may have unwanted side||
1404|018|W|effects due to testosterone solution. Children should avoid||
1404|019|W|contact with any unwashed or unclothed area where the medication||
1404|020|W|has been applied. Tell both of your doctors right away if you||
1404|021|W|notice unexpected signs of puberty in a child such as unusual||
1404|022|W|increase in size of genitals (penis or clitoris), early||
1404|023|W|development of pubic hair, increased erections (in boys) or sex||
1404|024|W|drive, or aggressive behavior. To decrease this risk, carefully||
1404|025|W|follow all directions for the proper use of this drug.||
1404|026|B|||
1404|027|U|USES:  This medicated solution contains testosterone. It is used||
1404|028|U|for hormone replacement in men who are not able to produce enough||
1404|029|U|testosterone (hypogonadism). This medication is absorbed through||
1404|030|U|the skin, enters your bloodstream, and helps your body reach||
1404|031|U|normal testosterone levels.||
1404|032|U|   Testosterone helps the body to develop and maintain the male||
1404|033|U|sexual characteristics (masculinity), such as a deep voice and||
1404|034|U|body hair. It also helps to maintain muscle and prevent bone||
1404|035|U|loss, and is necessary for natural sexual ability/desire.||
1404|036|U|   Women should not use this drug.||
1404|037|B|||
1404|038|H|HOW TO USE:  Read the Medication Guide provided by your||
1404|039|H|pharmacist before you start using testosterone solution and each||
1404|040|H|time you get a refill. Learn how to use the pump and how to apply||
1404|041|H|the solution correctly. If you have any questions, ask your||
1404|042|H|doctor or pharmacist.||
1404|043|H|   There are many testosterone products available for use on the||
1404|044|H|skin. They may have different amounts of testosterone and may not||
1404|045|H|have the same effects. Read the dosing instructions carefully for||
1404|046|H|each product. Do not change products without asking your doctor||
1404|047|H|or pharmacist.||
1404|048|H|   Follow the instructions for priming the pump if you are using||
1404|049|H|it for the first time.||
1404|050|H|   If you use antiperspirant and/or deodorant, you should use||
1404|051|H|those first before applying this medication.||
1404|052|H|   Pump this medication into the applicator cup as directed. Do||
1404|053|H|not pump more than one pump of this medication into the||
1404|054|H|applicator at a time. Keeping the applicator upright, use it to||
1404|055|H|apply the medication to clean, dry skin on the armpit(s) as||
1404|056|H|directed by your doctor, usually once daily in the morning. Avoid||
1404|057|H|applying this medication to broken, irritated skin. After||
1404|058|H|applying, do not rub in the solution with your fingers or hand.||
1404|059|H|If your dose requires you to apply more medication to the same||
1404|060|H|armpit, wait for the medication to dry before applying more||
1404|061|H|medication. Do not apply this medication to other areas of the||
1404|062|H|body, including the genitals (penis or scrotum).||
1404|063|H|   The dosage is based on your medical condition, lab tests, and||
1404|064|H|response to treatment. Follow your doctor's instructions||
1404|065|H|carefully on the exact number of pumps for each dose.||
1404|066|H|   Wait a few minutes for the application site to dry completely||
1404|067|H|before dressing. Be sure to always wear clothing (such as a||
1404|068|H|t-shirt) to cover the application site until you wash the areas||
1404|069|H|well with soap and water. To get the best effect, wait at least 2||
1404|070|H|hours before showering/swimming to allow the drug to be absorbed||
1404|071|H|through the skin.||
1404|072|H|   After applying this medication, rinse the applicator cup with||
1404|073|H|running water and then pat dry with a tissue. Replace the||
1404|074|H|applicator and cap back onto the bottle. Wash your hands||
1404|075|H|thoroughly with soap and water.||
1404|076|H|   Use this medication regularly in order to get the most benefit||
1404|077|H|from it. To help you remember, use it at the same time each day.||
1404|078|H|   Misuse or abuse of testosterone can cause serious side effects||
1404|079|H|such as heart disease (including heart attack), stroke, liver||
1404|080|H|disease, mental/mood problems, abnormal drug-seeking behavior, or||
1404|081|H|improper bone growth (in adolescents). Do not increase your dose||
1404|082|H|or use this drug more often or for longer than prescribed. When||
1404|083|H|testosterone is misused or abused, you may have withdrawal||
1404|084|H|symptoms (such as depression, irritability, tiredness) when you||
1404|085|H|suddenly stop using the drug. These symptoms may last from weeks||
1404|086|H|to months.||
1404|087|H|   This medication is flammable until dry. Avoid smoking or being||
1404|088|H|near open flames while using the medication and until the||
1404|089|H|medication has dried.||
1404|090|H|   Tell your doctor if your condition does not get better or if||
1404|091|H|it gets worse.||
1404|092|B|||
1404|093|S|SIDE EFFECTS:  Redness/irritation at the application site,||
1404|094|S|headache, diarrhea, vomiting, and acne may occur. If any of these||
1404|095|S|effects last or get worse, tell your doctor or pharmacist||
1404|096|S|promptly.||
1404|097|S|   Remember that this medication has been prescribed because your||
1404|098|S|doctor has judged that the benefit to you is greater than the||
1404|099|S|risk of side effects. Many people using this medication do not||
1404|100|S|have serious side effects.||
1404|101|S|   This medication may raise your blood pressure. Check your||
1404|102|S|blood pressure regularly and tell your doctor if the results are||
1404|103|S|high. Your doctor may control your blood pressure with||
1404|104|S|medication.||
1404|105|S|   Tell your doctor right away if you have any serious side||
1404|106|S|effects, including: nausea/vomiting that doesn't stop, severe||
1404|107|S|stomach/abdominal pain, dark urine, yellowing eyes/skin, swelling||
1404|108|S|hands/ankles/feet, breast pain/enlargement, very||
1404|109|S|slow/shallow/difficult breathing (possibly while sleeping),||
1404|110|S|difficulty urinating, increased urination (especially at night),||
1404|111|S|mental/mood changes (such as depression, agitation, hostility),||
1404|112|S|testicle pain/tenderness, fast/irregular heartbeat.||
1404|113|S|   Get medical help right away if you have any very serious side||
1404|114|S|effects, including: shortness of breath/rapid breathing,||
1404|115|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1404|116|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1404|117|S|sudden/severe headaches, trouble speaking, weakness on one side||
1404|118|S|of the body, sudden vision changes.||
1404|119|S|   In patients with diabetes, especially those taking insulin,||
1404|120|S|testosterone may decrease your blood sugar. Be prepared to treat||
1404|121|S|low blood sugar while you are using this medication. Tell your||
1404|122|S|doctor right away if you have symptoms of low blood sugar such as||
1404|123|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
1404|124|S|dizziness, or tingling hands/feet.||
1404|125|S|   Rarely, males may have a painful or prolonged erection lasting||
1404|126|S|4 or more hours. If this occurs, stop using this drug and get||
1404|127|S|medical help right away, or permanent problems could occur.||
1404|128|S|   A very serious allergic reaction to this product is rare.||
1404|129|S|However, get medical help right away if you notice any symptoms||
1404|130|S|of a serious allergic reaction, including: rash, itching/swelling||
1404|131|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1404|132|S|breathing.||
1404|133|S|   This is not a complete list of possible side effects. If you||
1404|134|S|notice other effects not listed above, contact your doctor or||
1404|135|S|pharmacist.||
1404|136|S|   In the US -||
1404|137|S|   Call your doctor for medical advice about side effects. You||
1404|138|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1404|139|S|www.fda.gov/medwatch.||
1404|140|S|   In Canada - Call your doctor for medical advice about side||
1404|141|S|effects. You may report side effects to Health Canada at||
1404|142|S|1-866-234-2345.||
1404|143|B|||
1404|144|P|PRECAUTIONS:  See also Warning section.||
1404|145|P|   Before using testosterone, tell your doctor or pharmacist if||
1404|146|P|you are allergic to it; or if you have any other allergies. This||
1404|147|P|product may contain inactive ingredients, which can cause||
1404|148|P|allergic reactions or other problems. Talk to your pharmacist for||
1404|149|P|more details.||
1404|150|P|   Before using this medication, tell your doctor or pharmacist||
1404|151|P|your medical history, especially of: breast cancer (males),||
1404|152|P|prostate problems (such as cancer, enlarged prostate or BPH),||
1404|153|P|difficulty breathing during sleep (apnea), high cholesterol||
1404|154|P|level, bone cancer, diabetes, high blood pressure, heart problems||
1404|155|P|(such as heart failure, heart attack), stroke, blood clots (such||
1404|156|P|as in the leg, lungs).||
1404|157|P|   Direct contact with the application site can expose others to||
1404|158|P|this medication. Women and children should avoid contact with any||
1404|159|P|unwashed or unclothed area where the medication has been applied.||
1404|160|P|If you expect to have skin-to-skin contact with another person,||
1404|161|P|first wash the application area well with soap and water. If a||
1404|162|P|woman or child makes contact with the application area, that area||
1404|163|P|on the woman or child should be washed well with soap and water||
1404|164|P|right away.||
1404|165|P|   If this medication accidentally gets into your eyes, rinse the||
1404|166|P|eyes right away with clean, warm water. Get medical help right||
1404|167|P|away if necessary.||
1404|168|P|   Before having surgery, tell your doctor or dentist about all||
1404|169|P|the products you use (including prescription drugs,||
1404|170|P|nonprescription drugs, and herbal products).||
1404|171|P|   Some men, particularly older adults, are at a higher risk for||
1404|172|P|developing enlarged prostate or prostate cancer while using this||
1404|173|P|medication. Your risk of prostate problems should be checked by||
1404|174|P|your doctor before you start testosterone.||
1404|175|P|   Children may be more sensitive to the side effects of this||
1404|176|P|drug. In children, it may affect bone growth. Monitor your||
1404|177|P|child's height periodically.||
1404|178|P|   This medication can affect fertility in males. Ask your doctor||
1404|179|P|for more details.||
1404|180|P|   This medication should not be used by women. Women||
1404|181|P|accidentally exposed to this medication may have side effects due||
1404|182|P|to testosterone solution. If you notice symptoms in a woman such||
1404|183|P|as changes in body hair or a large increase in acne, talk to her||
1404|184|P|doctor and your doctor right away. Women who are pregnant or||
1404|185|P|breastfeeding must avoid contact with this medication. This||
1404|186|P|medication may harm an unborn or breastfeeding baby. Consult your||
1404|187|P|doctor for more details.||
1404|188|B|||
1404|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1404|190|I|medications work or increase your risk for serious side effects.||
1404|191|I|This document does not contain all possible drug interactions.||
1404|192|I|Keep a list of all the products you use (including||
1404|193|I|prescription/nonprescription drugs and herbal products) and share||
1404|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
1404|195|I|the dosage of any medicines without your doctor's approval.||
1404|196|I|   Some products that may interact with this drug include: "blood||
1404|197|I|thinners" (such as warfarin).||
1404|198|I|   This medication may interfere with certain lab tests (such as||
1404|199|I|thyroid function tests, creatinine level), possibly causing false||
1404|200|I|test results. Make sure lab personnel and all your doctors know||
1404|201|I|you use this drug.||
1404|202|B|||
1404|203|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1404|204|O|has overdosed and has serious symptoms such as passing out or||
1404|205|O|trouble breathing, call 911. Otherwise, call a poison control||
1404|206|O|center right away. US residents can call 1-800-222-1222. Canada||
1404|207|O|residents can call 1-844-764-7669.||
1404|208|B|||
1404|209|N|NOTES:  Do not share this medication with others. Sharing it is||
1404|210|N|against the law.||
1404|211|N|   Lab and/or medical tests (such as PSA, cholesterol,||
1404|212|N|hemoglobin/hematocrit, testosterone blood levels, prostate exams)||
1404|213|N|should be done while you are using this medication. Keep all||
1404|214|N|medical and lab appointments. Consult your doctor for more||
1404|215|N|details.||
1404|216|N|   This medication has been prescribed for your current condition||
1404|217|N|only. Do not use it later for another problem unless your doctor||
1404|218|N|directs you to do so. A different medication may be necessary in||
1404|219|N|that case.||
1404|220|B|||
1404|221|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1404|222|D|If it is near the time of the next dose, skip the missed dose.||
1404|223|D|Use your next dose at the regular time. Do not double the dose to||
1404|224|D|catch up.||
1404|225|B|||
1404|226|R|STORAGE:  Store upright at room temperature. Do not store near an||
1404|227|R|open flame. Discard used pumps in a secure trash can. Keep all||
1404|228|R|medications away from children and pets.||
1404|229|R|   Do not flush medications down the toilet or pour them into a||
1404|230|R|drain unless instructed to do so. Properly discard this product||
1404|231|R|when it is expired or no longer needed. Consult your pharmacist||
1404|232|R|or local waste disposal company.||
1404|233|B|||
1404|234|A|Information last revised July 2025.||
1404|235|A|Copyright(c) 2025 First Databank, Inc.||
1404|236|B|||
1405|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1405|002|Z|does NOT have all possible information about this product. This||
1405|003|Z|information does not assure that this product is safe, effective,||
1405|004|Z|or appropriate for you. This information is not individual||
1405|005|Z|medical advice and does not substitute for the advice of your||
1405|006|Z|health care professional. Always ask your health care||
1405|007|Z|professional for complete information about this product and your||
1405|008|Z|specific health needs.||
1405|009|B|||
1405|010|T|NON-OPIOID ANTITUSSIVE/DECONGESTANT/ANTIHISTAMINE - ORAL||
1405|011|B|||
1405|012|U|USES:  This combination medication is used to relieve symptoms||
1405|013|U|caused by the common cold, flu, allergies, "hay fever," and other||
1405|014|U|breathing illnesses (such as sinusitis, bronchitis). These||
1405|015|U|symptoms include cough, watery eyes, itchy eyes/nose/throat,||
1405|016|U|runny nose, and sneezing. This product contains a cough||
1405|017|U|suppressant (such as chlophedianol) that affects a certain part||
1405|018|U|of the brain, reducing the urge to cough. This product also||
1405|019|U|contains a decongestant (such as pseudoephedrine, phenylephrine),||
1405|020|U|which helps relieve stuffy nose symptoms. It also contains an||
1405|021|U|antihistamine (such as brompheniramine, triprolidine, among||
1405|022|U|others), which helps relieve watery eyes, itchy eyes/nose/throat,||
1405|023|U|runny nose, and sneezing.||
1405|024|U|   This medication is not usually used for ongoing coughs from||
1405|025|U|smoking, asthma, or other long-term breathing problems (such as||
1405|026|U|emphysema), or for coughs with a lot of mucus, unless directed by||
1405|027|U|your doctor.||
1405|028|U|   Cough-and-cold products have not been shown to be safe or||
1405|029|U|effective in children younger than 6 years. Do not use this||
1405|030|U|product to treat cold symptoms in children younger than 6 years||
1405|031|U|unless specifically directed by the doctor. Some products (such||
1405|032|U|as long-acting tablets/capsules) are not recommended for use in||
1405|033|U|children younger than 12 years. Ask your doctor or pharmacist for||
1405|034|U|more details about using your product safely.||
1405|035|U|   These products do not cure or shorten the length of the common||
1405|036|U|cold and may cause serious side effects. To decrease the risk for||
1405|037|U|serious side effects, carefully follow all dosage directions. Do||
1405|038|U|not use this product to make a child sleepy. Do not give other||
1405|039|U|cough-and-cold medication that might contain the same or similar||
1405|040|U|ingredients (see also Drug Interactions section). Ask the doctor||
1405|041|U|or pharmacist about other ways to relieve cough and cold symptoms||
1405|042|U|(such as drinking enough fluids, using a humidifier or saline||
1405|043|U|nose drops/spray).||
1405|044|B|||
1405|045|H|HOW TO USE:  Take this medication by mouth with or without food.||
1405|046|H|If stomach upset occurs, take this product with food or milk.||
1405|047|H|Drink plenty of fluids when you use this medication unless||
1405|048|H|otherwise directed by your doctor. The fluid will help loosen the||
1405|049|H|mucus in your lungs.||
1405|050|H|   The dosage is based on your age, medical condition, and||
1405|051|H|response to treatment. Long-acting products are usually taken||
1405|052|H|twice a day. Some products may be taken every 4 to 6 hours as||
1405|053|H|needed. Follow your doctor's directions carefully. Do not||
1405|054|H|increase your dose or take this medication more often than||
1405|055|H|prescribed without your doctor's approval. If you are taking this||
1405|056|H|medication for allergy or hay fever, take it regularly to get the||
1405|057|H|most benefit from it.||
1405|058|H|   If you are using the liquid form, use a medication-measuring||
1405|059|H|device or spoon to carefully measure the prescribed dose. Do not||
1405|060|H|use a household spoon because you may not get the correct dose.||
1405|061|H|If your liquid form is a suspension, shake the bottle well before||
1405|062|H|each dose.||
1405|063|H|   If you are using the chewable form, chew the tablets||
1405|064|H|thoroughly before swallowing.||
1405|065|H|   Tell your doctor if your condition lasts for more than 1 week,||
1405|066|H|if it gets worse, or if it occurs with a headache that doesn't go||
1405|067|H|away, fever, or rash. These may be symptoms of a serious medical||
1405|068|H|problem and should be checked by a doctor.||
1405|069|B|||
1405|070|S|SIDE EFFECTS:  Drowsiness, dizziness, flushing, headache, nausea,||
1405|071|S|nervousness, blurred vision, or dry mouth/nose/throat may occur.||
1405|072|S|If any of these effects last or get worse, tell your doctor or||
1405|073|S|pharmacist promptly.||
1405|074|S|   To reduce the risk of dizziness and lightheadedness, get up||
1405|075|S|slowly when rising from a sitting or lying position.||
1405|076|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
1405|077|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1405|078|S|substitute.||
1405|079|S|   Remember that this medication has been prescribed because your||
1405|080|S|doctor has judged that the benefit to you is greater than the||
1405|081|S|risk of side effects. Many people using this medication do not||
1405|082|S|have serious side effects.||
1405|083|S|   This medication may raise your blood pressure. Check your||
1405|084|S|blood pressure regularly and tell your doctor if the results are||
1405|085|S|high.||
1405|086|S|   Tell your doctor right away if you have any serious side||
1405|087|S|effects, including: mental/mood changes (such as hallucinations,||
1405|088|S|confusion), shaking (tremors), trouble urinating, weakness.||
1405|089|S|   Get medical help right away if you have any very serious side||
1405|090|S|effects, including: fast/slow/irregular heartbeat, seizure.||
1405|091|S|   A very serious allergic reaction to this drug is rare.||
1405|092|S|However, get medical help right away if you notice any symptoms||
1405|093|S|of a serious allergic reaction, including: rash, itching/swelling||
1405|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1405|095|S|breathing.||
1405|096|S|   This is not a complete list of possible side effects. If you||
1405|097|S|notice other effects not listed above, contact your doctor or||
1405|098|S|pharmacist.||
1405|099|S|   In the US -||
1405|100|S|   Call your doctor for medical advice about side effects. You||
1405|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1405|102|S|www.fda.gov/medwatch.||
1405|103|S|   In Canada - Call your doctor for medical advice about side||
1405|104|S|effects. You may report side effects to Health Canada at||
1405|105|S|1-866-234-2345.||
1405|106|B|||
1405|107|P|PRECAUTIONS:  Before taking this medication, tell your doctor if||
1405|108|P|you are allergic to any of its ingredients; or if you have any||
1405|109|P|other allergies. This product may contain inactive ingredients,||
1405|110|P|which can cause allergic reactions or other problems. Talk to||
1405|111|P|your pharmacist for more details.||
1405|112|P|   Before taking this medication, tell your doctor or pharmacist||
1405|113|P|your medical history, especially of: breathing problems (such as||
1405|114|P|asthma, emphysema), diabetes, glaucoma, heart problems, high||
1405|115|P|blood pressure, seizures, overactive thyroid (hyperthyroidism),||
1405|116|P|kidney problems, urination problems (such as trouble urinating||
1405|117|P|due to enlarged prostate, urinary retention).||
1405|118|P|   This drug may make you dizzy or drowsy or blur your vision.||
1405|119|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1405|120|P|drowsy. Do not drive, use machinery, or do anything that needs||
1405|121|P|alertness or clear vision until you can do it safely. Limit||
1405|122|P|alcoholic beverages. Talk to your doctor if you are using||
1405|123|P|marijuana (cannabis).||
1405|124|P|   Some brands may contain sugar, alcohol, or aspartame. Caution||
1405|125|P|is advised if you have diabetes, alcohol dependence, liver||
1405|126|P|disease, phenylketonuria (PKU), or any other condition that||
1405|127|P|requires you to limit/avoid these substances in your diet. Ask||
1405|128|P|your doctor or pharmacist about using this product safely.||
1405|129|P|   Before having surgery, tell your doctor or dentist about all||
1405|130|P|the products you use (including prescription drugs,||
1405|131|P|nonprescription drugs, and herbal products).||
1405|132|P|   Children may be more sensitive to the side effects of||
1405|133|P|antihistamines. In young children, this medication may cause||
1405|134|P|agitation/excitement instead of drowsiness.||
1405|135|P|   Older adults may be more sensitive to the side effects of this||
1405|136|P|drug, especially dizziness, drowsiness, mental/mood changes, and||
1405|137|P|blood pressure changes.||
1405|138|P|   During pregnancy, this medication should be used only when||
1405|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
1405|140|P|   This drug may pass into breast milk and could have undesirable||
1405|141|P|effects on a nursing infant. Consult your doctor before||
1405|142|P|breastfeeding.||
1405|143|B|||
1405|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1405|145|I|medications work or increase your risk for serious side effects.||
1405|146|I|This document does not contain all possible drug interactions.||
1405|147|I|Keep a list of all the products you use (including||
1405|148|I|prescription/nonprescription drugs and herbal products) and share||
1405|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
1405|150|I|the dosage of any medicines without your doctor's approval.||
1405|151|I|   Some products that may interact with this drug are:||
1405|152|I|antihistamines applied to the skin (such as diphenhydramine||
1405|153|I|cream, ointment, spray).||
1405|154|I|   Taking MAO inhibitors with this medication may cause a serious||
1405|155|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1405|156|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1405|157|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1405|158|I|selegiline, tranylcypromine) during treatment with this||
1405|159|I|medication. Most MAO inhibitors should also not be taken for two||
1405|160|I|weeks before treatment with this medication. Ask your doctor when||
1405|161|I|to start or stop taking this medication.||
1405|162|I|   The ingredients in this product are available in many||
1405|163|I|prescription and nonprescription products. Check the labels on||
1405|164|I|all your medications carefully to make sure you are not taking||
1405|165|I|more than one product with the same ingredient(s). Consult your||
1405|166|I|pharmacist if you are unsure of the ingredients in any of your||
1405|167|I|medications.||
1405|168|I|   Tell your doctor or pharmacist if you are taking other||
1405|169|I|products that cause drowsiness such as opioid pain or cough||
1405|170|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1405|171|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1405|172|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1405|173|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1405|174|I|diphenhydramine).||
1405|175|I|   Check the labels on all your medicines (such as allergy or||
1405|176|I|cough-and-cold products) because they may contain ingredients||
1405|177|I|that cause drowsiness. Ask your pharmacist about using those||
1405|178|I|products safely.||
1405|179|I|   This medication may interfere with certain lab tests (such as||
1405|180|I|allergy skin test), possibly causing false test results. Make||
1405|181|I|sure lab personnel and all your doctors know you use this drug.||
1405|182|B|||
1405|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1405|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1405|185|O|poison control center right away. US residents can call||
1405|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1405|187|O|Symptoms of overdose may include: large pupils, flushing, shaking||
1405|188|O|(tremor), hallucinations, confusion, seizures. In children,||
1405|189|O|excitement may occur first, and may be followed by loss of||
1405|190|O|coordination, drowsiness, loss of consciousness, seizures.||
1405|191|B|||
1405|192|N|NOTES:  Do not share this medication with others.||
1405|193|B|||
1405|194|D|MISSED DOSE:  If your doctor directs you to take this medication||
1405|195|D|on a regular schedule and you miss a dose, take it as soon as you||
1405|196|D|remember. If it is near the time of the next dose, skip the||
1405|197|D|missed dose. Take your next dose at the regular time. Do not||
1405|198|D|double the dose to catch up.||
1405|199|B|||
1405|200|R|STORAGE:  Store at room temperature away from light and moisture.||
1405|201|R|Do not store in the bathroom. Do not freeze liquid forms of this||
1405|202|R|medication. Keep all medications away from children and pets.||
1405|203|R|   Do not flush medications down the toilet or pour them into a||
1405|204|R|drain unless instructed to do so. Properly discard this product||
1405|205|R|when it is expired or no longer needed. Consult your pharmacist||
1405|206|R|or local waste disposal company.||
1405|207|B|||
1405|208|A|Information last revised July 2025.||
1405|209|A|Copyright(c) 2025 First Databank, Inc.||
1405|210|B|||
1406|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1406|002|Z|does NOT have all possible information about this product. This||
1406|003|Z|information does not assure that this product is safe, effective,||
1406|004|Z|or appropriate for you. This information is not individual||
1406|005|Z|medical advice and does not substitute for the advice of your||
1406|006|Z|health care professional. Always ask your health care||
1406|007|Z|professional for complete information about this product and your||
1406|008|Z|specific health needs.||
1406|009|B|||
1406|010|T|NEVIRAPINE EXTENDED-RELEASE - ORAL||
1406|011|F|(ne-VIR-a-peen)||
1406|012|B|||
1406|013|C|COMMON BRAND NAME(S): Viramune XR||
1406|014|B|||
1406|015|W|WARNING:  Rarely, nevirapine has caused severe (sometimes fatal)||
1406|016|W|liver problems. Get medical help right away if you develop||
1406|017|W|symptoms of liver problems, such as nausea that doesn't stop,||
1406|018|W|loss of appetite, vomiting, stomach/abdominal pain, dark urine,||
1406|019|W|pale stools, yellowing eyes/skin, unusual tiredness, rash.||
1406|020|W|   Rarely, nevirapine has also caused serious (sometimes fatal)||
1406|021|W|skin/allergic reactions. Get medical help right away if you have||
1406|022|W|any signs of skin/allergic reactions, including sore throat that||
1406|023|W|doesn't go away, swollen lymph nodes, rash,||
1406|024|W|itching/swelling/redness (especially of the eyes/face), blisters,||
1406|025|W|fever, unusual tiredness, mouth sores, severe dizziness, trouble||
1406|026|W|breathing, signs of kidney problems (such as change in the amount||
1406|027|W|of urine), muscle pain/tenderness/weakness, joint pain.||
1406|028|W|   Women are at increased risk for developing these severe||
1406|029|W|reactions. To help decrease the risk of skin/allergic reactions||
1406|030|W|in all patients, nevirapine is started at a lower dose for the||
1406|031|W|first 14 days. Also, people with higher T-cell counts at the||
1406|032|W|start of nevirapine treatment are at greater risk for liver||
1406|033|W|problems. Nevirapine is usually only started if the T-cell count||
1406|034|W|is fewer than 250 in women or fewer than 400 in men.||
1406|035|W|   Keep all medical and lab appointments so your doctor can||
1406|036|W|monitor how you are responding to nevirapine. The risk of these||
1406|037|W|serious side effects is high in the first 18 weeks and highest||
1406|038|W|during the first 6 weeks of nevirapine treatment. However, these||
1406|039|W|side effects may occur at any time while taking this medication.||
1406|040|W|   If you have stopped taking nevirapine because of liver||
1406|041|W|problems or skin/allergic reactions, you must never take any form||
1406|042|W|of nevirapine again. Tell all of your doctors and pharmacists if||
1406|043|W|you have ever stopped taking nevirapine because of these types of||
1406|044|W|reactions.||
1406|045|B|||
1406|046|U|USES:  Nevirapine is used with other HIV medications to help||
1406|047|U|control HIV infection. It helps to decrease the amount of HIV in||
1406|048|U|your body so your immune system can work better. This lowers your||
1406|049|U|chance of getting HIV complications (such as new infections,||
1406|050|U|cancer) and improves your quality of life. Nevirapine belongs to||
1406|051|U|a class of drugs known as non-nucleoside reverse transcriptase||
1406|052|U|inhibitors (NNRTIs).||
1406|053|U|   Nevirapine is not a cure for HIV infection. To decrease your||
1406|054|U|risk of spreading HIV disease to others, continue to take all HIV||
1406|055|U|medications exactly as prescribed by your doctor. Use an||
1406|056|U|effective barrier method (latex or polyurethane condoms/dental||
1406|057|U|dams) during sexual activity as directed by your doctor. Do not||
1406|058|U|share personal items (such as needles/syringes, toothbrushes, and||
1406|059|U|razors) that may have contacted blood or other body fluids.||
1406|060|U|Consult your doctor or pharmacist for more details.||
1406|061|U|   Nevirapine should not be used to prevent HIV infection after||
1406|062|U|accidental exposure (such as needle sticks, blood/bodily fluid||
1406|063|U|contact). Different HIV medications are used to prevent infection||
1406|064|U|after exposure.||
1406|065|B|||
1406|066|H|HOW TO USE:  Read the Medication Guide provided by your||
1406|067|H|pharmacist before you start using nevirapine and each time you||
1406|068|H|get a refill. If you have any questions, ask your doctor or||
1406|069|H|pharmacist.||
1406|070|H|   Take this medication by mouth with or without food as directed||
1406|071|H|by your doctor, usually once daily. Do not crush, chew, or split||
1406|072|H|the tablets. Doing so can release all of the drug at once and||
1406|073|H|increase the risk of side effects.||
1406|074|H|   If you have never taken nevirapine before, you must take the||
1406|075|H|immediate-release form of nevirapine for 14 days, before starting||
1406|076|H|to take the extended-release form. If you have already taken the||
1406|077|H|immediate-release form of nevirapine for more than 14 days, you||
1406|078|H|may start taking the extended-release tablets right away.||
1406|079|H|However, never take two different forms of nevirapine at the same||
1406|080|H|time.||
1406|081|H|   The dosage is based on your medical condition and response to||
1406|082|H|treatment. Children's dosage is also based on body size.||
1406|083|H|   If you stop taking this medication for more than 7 days for||
1406|084|H|reasons other than the serious reactions described in the Warning||
1406|085|H|section, ask your doctor for directions on how to restart||
1406|086|H|treatment. You may need to take the immediate-release form of||
1406|087|H|this medication once daily again for the first 14 days to||
1406|088|H|decrease the risk of serious side effects.||
1406|089|H|   It is very important to keep taking this medication (and other||
1406|090|H|HIV medications) exactly as prescribed by your doctor. Do not||
1406|091|H|skip any doses. Do not increase your dose, take this drug more||
1406|092|H|often than prescribed, or stop taking it (or other HIV medicines)||
1406|093|H|even for a short time unless directed to do so by your doctor.||
1406|094|H|Skipping or changing your dose without approval from your doctor||
1406|095|H|may cause the amount of virus to increase, make the infection||
1406|096|H|more difficult to treat (resistant), or worsen side effects.||
1406|097|H|   For the best effect, take this medication at evenly spaced||
1406|098|H|times. To help you remember, take this medication at the same||
1406|099|H|time every day.||
1406|100|B|||
1406|101|S|SIDE EFFECTS:  See also Warning section.||
1406|102|S|   Tiredness, nausea, vomiting, or diarrhea may occur. Drowsiness||
1406|103|S|may rarely occur. If any of these effects last or get worse, tell||
1406|104|S|your doctor or pharmacist promptly.||
1406|105|S|   You may see the empty extended-release tablet shell in your||
1406|106|S|stool. This is harmless.||
1406|107|S|   Remember that this medication has been prescribed because your||
1406|108|S|doctor has judged that the benefit to you is greater than the||
1406|109|S|risk of side effects. Many people using this medication do not||
1406|110|S|have serious side effects.||
1406|111|S|   As your immune system gets stronger, it can begin to fight off||
1406|112|S|infections you already had, possibly causing disease symptoms to||
1406|113|S|come back. You could also have symptoms if your immune system||
1406|114|S|becomes overactive. This reaction may happen at any time (soon||
1406|115|S|after starting HIV treatment or many months later). Tell your||
1406|116|S|doctor right away if you have any serious symptoms, including:||
1406|117|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1406|118|S|that doesn't go away, headaches that are severe or don't go away,||
1406|119|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1406|120|S|changes, signs of infection (such as sore throat that doesn't go||
1406|121|S|away, fever, chills, non-healing skin sores), signs of an||
1406|122|S|overactive thyroid (such as irritability, nervousness, heat||
1406|123|S|intolerance, fast/pounding/irregular heartbeat).||
1406|124|S|   Nevirapine can commonly cause a rash that is usually not||
1406|125|S|serious. However, you may not be able to tell it apart from a||
1406|126|S|rare rash that could be a sign of a severe reaction. Get medical||
1406|127|S|help right away if you develop any rash.||
1406|128|S|   Changes in body fat may occur while you are taking this||
1406|129|S|medication (such as increased fat in the upper back and stomach||
1406|130|S|areas, decreased fat in the arms and legs). The cause and||
1406|131|S|long-term effects of these changes are unknown. Discuss the risks||
1406|132|S|and benefits of treatment with your doctor, as well as the||
1406|133|S|possible use of exercise to reduce this side effect.||
1406|134|S|   A very serious allergic reaction to this drug is rare, but get||
1406|135|S|medical help right away if it occurs. See the Warning section for||
1406|136|S|more details.||
1406|137|S|   This is not a complete list of possible side effects. If you||
1406|138|S|notice other effects not listed above, contact your doctor or||
1406|139|S|pharmacist.||
1406|140|S|   In the US -||
1406|141|S|   Call your doctor for medical advice about side effects. You||
1406|142|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1406|143|S|www.fda.gov/medwatch.||
1406|144|S|   In Canada - Call your doctor for medical advice about side||
1406|145|S|effects. You may report side effects to Health Canada at||
1406|146|S|1-866-234-2345.||
1406|147|B|||
1406|148|P|PRECAUTIONS:  Before taking nevirapine, tell your doctor or||
1406|149|P|pharmacist if you are allergic to it; or if you have any other||
1406|150|P|allergies. This product may contain inactive ingredients, which||
1406|151|P|can cause allergic reactions or other problems. Talk to your||
1406|152|P|pharmacist for more details.||
1406|153|P|   Before using this medication, tell your doctor or pharmacist||
1406|154|P|your medical history, especially of: liver problems (such as||
1406|155|P|hepatitis B or C, cirrhosis), kidney dialysis.||
1406|156|P|   This drug may rarely make you drowsy. Alcohol or marijuana||
1406|157|P|(cannabis) can make you more drowsy. Do not drive, use machinery,||
1406|158|P|or do anything that needs alertness until you can do it safely.||
1406|159|P|Limit alcoholic beverages. Talk to your doctor if you are using||
1406|160|P|marijuana (cannabis).||
1406|161|P|   Before having surgery, tell your doctor or dentist about all||
1406|162|P|the products you use (including prescription drugs,||
1406|163|P|nonprescription drugs, and herbal products).||
1406|164|P|   During pregnancy, this medication should be used only when||
1406|165|P|clearly needed. Treatment can lower the risk of passing HIV||
1406|166|P|infection to your baby, and nevirapine may be part of that||
1406|167|P|treatment. Discuss the risks and benefits with your doctor.||
1406|168|P|   This medication passes into breast milk. Because breast milk||
1406|169|P|may transmit HIV, consult your doctor before breastfeeding.||
1406|170|B|||
1406|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1406|172|I|medications work or increase your risk for serious side effects.||
1406|173|I|This document does not contain all possible drug interactions.||
1406|174|I|Keep a list of all the products you use (including||
1406|175|I|prescription/nonprescription drugs and herbal products) and share||
1406|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
1406|177|I|the dosage of any medicines without your doctor's approval.||
1406|178|I|   Some products that may interact with this drug include:||
1406|179|I|orlistat, rifabutin, warfarin.||
1406|180|I|   Other medications can affect the removal of nevirapine from||
1406|181|I|your body, which may affect how nevirapine works. Examples||
1406|182|I|include rifamycins (such as rifampin), St. John's wort, among||
1406|183|I|others.||
1406|184|I|   Nevirapine can speed up the removal of many other medications||
1406|185|I|from your body, which may affect how they work. Examples of||
1406|186|I|affected drugs include antiarrhythmics (such as amiodarone),||
1406|187|I|atazanavir, cobicistat, elvitegravir, some drugs used to treat||
1406|188|I|seizures (such as clonazepam), azole antifungals (such as||
1406|189|I|itraconazole, ketoconazole), macrolide antibiotics (such as||
1406|190|I|clarithromycin), methadone, among others.||
1406|191|I|   Do not use prednisone to prevent a rash because it can||
1406|192|I|actually increase the risk of a rash during the first 6 weeks of||
1406|193|I|nevirapine treatment. Ask your doctor for more details.||
1406|194|I|   This medication may decrease the effectiveness of hormonal||
1406|195|I|birth control such as pills, patch, or ring. This could cause||
1406|196|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1406|197|I|use reliable backup birth control methods while using this||
1406|198|I|medication. Also tell your doctor if you have any new spotting or||
1406|199|I|breakthrough bleeding, because these may be signs that your birth||
1406|200|I|control is not working well.||
1406|201|B|||
1406|202|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1406|203|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1406|204|O|poison control center right away. US residents can call||
1406|205|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1406|206|B|||
1406|207|N|NOTES:  Do not share this medication with others.||
1406|208|N|   Lab and/or medical tests (such as liver function, viral load,||
1406|209|N|T-cell counts) should be done while you are taking this||
1406|210|N|medication. Keep all medical and lab appointments. Consult your||
1406|211|N|doctor for more details.||
1406|212|B|||
1406|213|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1406|214|D|remember. If it is near the time of the next dose, skip the||
1406|215|D|missed dose. Take your next dose at the regular time. Do not||
1406|216|D|double the dose to catch up.||
1406|217|B|||
1406|218|R|STORAGE:  Store at room temperature away from light and moisture.||
1406|219|R|Do not store in the bathroom. Keep all medications away from||
1406|220|R|children and pets.||
1406|221|R|   Do not flush medications down the toilet or pour them into a||
1406|222|R|drain unless instructed to do so. Properly discard this product||
1406|223|R|when it is expired or no longer needed. Consult your pharmacist||
1406|224|R|or local waste disposal company.||
1406|225|B|||
1406|226|A|Information last revised April 2025.||
1406|227|A|Copyright(c) 2025 First Databank, Inc.||
1406|228|B|||
1407|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1407|002|Z|does NOT have all possible information about this product. This||
1407|003|Z|information does not assure that this product is safe, effective,||
1407|004|Z|or appropriate for you. This information is not individual||
1407|005|Z|medical advice and does not substitute for the advice of your||
1407|006|Z|health care professional. Always ask your health care||
1407|007|Z|professional for complete information about this product and your||
1407|008|Z|specific health needs.||
1407|009|B|||
1407|010|T|ESTRADIOL GEL PUMP - TRANSDERMAL||
1407|011|F|(ES-tra-DYE-ol)||
1407|012|B|||
1407|013|C|COMMON BRAND NAME(S): Elestrin, EstroGel||
1407|014|B|||
1407|015|W|WARNING:  Estrogens, either used alone or with another hormone||
1407|016|W|(progestin), have rarely caused very serious side effects.||
1407|017|W|Discuss the risks and benefits of hormone treatment with your||
1407|018|W|doctor. Estrogens should not be used to prevent heart disease or||
1407|019|W|dementia.||
1407|020|W|   Estrogens can increase the risk of cancer of the uterus||
1407|021|W|(endometrial cancer). Taking a progestin as directed by your||
1407|022|W|doctor can help decrease this risk. Tell your doctor right away||
1407|023|W|if you have any unusual vaginal bleeding.||
1407|024|W|   In postmenopausal women, estrogens, taken with or without a||
1407|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
1407|026|W|stroke, dementia, and serious blood clots. When used along with a||
1407|027|W|progestin, estrogens also increase the risk of heart disease||
1407|028|W|(such as heart attacks).||
1407|029|W|   The risk for serious side effects may depend on the dose of||
1407|030|W|estrogen and the length of time it is used. This medication||
1407|031|W|should be used at the lowest effective dose and for the shortest||
1407|032|W|amount of time. Discuss the use of this medication with your||
1407|033|W|doctor regularly (for example, every 3 to 6 months) to see if you||
1407|034|W|still need to use it. If you will be taking this medication||
1407|035|W|long-term, you should have regular complete physical exams (for||
1407|036|W|example, once a year) as directed by your doctor. See also Notes||
1407|037|W|section.||
1407|038|B|||
1407|039|U|USES:  This medication is a hormone (estrogen). It is absorbed||
1407|040|U|through the skin and enters into the bloodstream. It is used by||
1407|041|U|women to help reduce a certain symptom of menopause (hot||
1407|042|U|flashes). Certain brands may also help to reduce vaginal symptoms||
1407|043|U|of menopause (such as vaginal dryness/burning/itching). These||
1407|044|U|symptoms are caused by the body making less estrogen. If you are||
1407|045|U|using this medication to treat symptoms only in and around the||
1407|046|U|vagina, products applied directly inside the vagina should be||
1407|047|U|considered before medications that are taken by mouth, absorbed||
1407|048|U|through the skin, or injected.||
1407|049|B|||
1407|050|V|OTHER USES:  This section contains uses of this drug that are not||
1407|051|V|listed in the approved professional labeling for the drug but||
1407|052|V|that may be prescribed by your health care professional. Use this||
1407|053|V|drug for a condition that is listed in this section only if it||
1407|054|V|has been so prescribed by your health care professional.||
1407|055|V|   Certain estrogen products may also be prescribed for bone loss||
1407|056|V|(osteoporosis) in women after menopause. However, there are other||
1407|057|V|medications (such as raloxifene, bisphosphonates including||
1407|058|V|alendronate) that are also effective in preventing bone loss and||
1407|059|V|may be safer. These medications should be considered for use||
1407|060|V|before estrogen treatment.||
1407|061|B|||
1407|062|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1407|063|H|from your pharmacist before you start using this medication and||
1407|064|H|each time you get a refill. Learn how to use the pump and how to||
1407|065|H|apply the gel correctly. If you have any questions, ask your||
1407|066|H|doctor or pharmacist.||
1407|067|H|   Follow the instructions for priming the pump if you are using||
1407|068|H|it for the first time.||
1407|069|H|   Use exactly as directed by your doctor. Apply the medication||
1407|070|H|to clean, dry skin on the upper arm/shoulder area, usually once||
1407|071|H|daily. Some brands may be applied on the arm from the wrist to||
1407|072|H|the shoulder. Follow the directions for your specific brand.||
1407|073|H|Avoid applying this medication to broken, irritated skin. Do not||
1407|074|H|apply this medication to the breast, face, or in or around the||
1407|075|H|vagina. Do not let others apply this medication to your body.||
1407|076|H|   The dosage is based on your medical condition and response to||
1407|077|H|treatment. Do not increase your dose or use this medication more||
1407|078|H|often than prescribed.||
1407|079|H|   Replace the cap on the pump after each use. After applying||
1407|080|H|this medication, wash your hands thoroughly with soap and water||
1407|081|H|to reduce the risk of accidentally spreading it from your hands||
1407|082|H|to other people. Wait about 5 minutes for the application site to||
1407|083|H|dry completely before dressing. Cover the application site with||
1407|084|H|clothing (such as a long-sleeve shirt) to prevent others from||
1407|085|H|touching the application area and being exposed to the drug. Wait||
1407|086|H|at least 1 to 2 hours (depending on your brand) before allowing||
1407|087|H|others to touch the skin where the medication was applied. If||
1407|088|H|someone accidentally touches the gel (or the application area||
1407|089|H|within 1 to 2 hours), have them wash the area of contact on their||
1407|090|H|body with soap and water as soon as possible.||
1407|091|H|   To get the best effect, wait at least 2 hours before||
1407|092|H|showering/swimming to allow the drug to be absorbed through the||
1407|093|H|skin.||
1407|094|H|   Use this medication regularly in order to get the most benefit||
1407|095|H|from it. To help you remember, use it at the same time each day.||
1407|096|H|   Avoid getting this medication in the eyes. If this medication||
1407|097|H|gets in the eyes, rinse them right away with warm water. Tell||
1407|098|H|your doctor if you get any eye irritation.||
1407|099|H|   This medication is flammable until dry. Avoid smoking or being||
1407|100|H|near open flames while using the medication and until the||
1407|101|H|medication has dried.||
1407|102|H|   Learn how many doses the gel pump delivers. Keep track of the||
1407|103|H|number of doses used and discard the pump after all the doses are||
1407|104|H|used, even though there may be some gel left in the pump.||
1407|105|H|   Tell your doctor if your condition does not get better or if||
1407|106|H|it gets worse.||
1407|107|B|||
1407|108|S|SIDE EFFECTS:  See also Warning section.||
1407|109|S|   Nausea/vomiting, bloating, breast tenderness, headache, or||
1407|110|S|weight changes may occur. If any of these effects last or get||
1407|111|S|worse, tell your doctor or pharmacist promptly.||
1407|112|S|   Remember that this medication has been prescribed because your||
1407|113|S|doctor has judged that the benefit to you is greater than the||
1407|114|S|risk of side effects. Many people using this medication do not||
1407|115|S|have serious side effects.||
1407|116|S|   Tell your doctor right away if you have any serious side||
1407|117|S|effects, including: nausea/vomiting that doesn't stop,||
1407|118|S|mental/mood changes (such as depression, memory loss), breast||
1407|119|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
1407|120|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
1407|121|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
1407|122|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
1407|123|S|increased thirst/urination.||
1407|124|S|   This medication may rarely cause serious (sometimes fatal)||
1407|125|S|problems from blood clots (such as heart attack, stroke, blood||
1407|126|S|clots in the lungs or legs). Get medical help right away if you||
1407|127|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
1407|128|S|headaches, weakness on one side of the body, confusion, trouble||
1407|129|S|speaking, sudden vision changes, pain/swelling/warmth in the||
1407|130|S|groin/calf, shortness of breath/rapid breathing, sudden||
1407|131|S|dizziness/fainting.||
1407|132|S|   A very serious allergic reaction to this product is rare.||
1407|133|S|However, get medical help right away if you notice any symptoms||
1407|134|S|of a serious allergic reaction, including: rash, itching/swelling||
1407|135|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1407|136|S|breathing.||
1407|137|S|   This is not a complete list of possible side effects. If you||
1407|138|S|notice other effects not listed above, contact your doctor or||
1407|139|S|pharmacist.||
1407|140|S|   In the US -||
1407|141|S|   Call your doctor for medical advice about side effects. You||
1407|142|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1407|143|S|www.fda.gov/medwatch.||
1407|144|S|   In Canada - Call your doctor for medical advice about side||
1407|145|S|effects. You may report side effects to Health Canada at||
1407|146|S|1-866-234-2345.||
1407|147|B|||
1407|148|P|PRECAUTIONS:  Before using estradiol, tell your doctor or||
1407|149|P|pharmacist if you are allergic to it; or if you have any other||
1407|150|P|allergies. This product may contain inactive ingredients, which||
1407|151|P|can cause allergic reactions or other problems. Talk to your||
1407|152|P|pharmacist for more details.||
1407|153|P|   Before using this medication, tell your doctor or pharmacist||
1407|154|P|your medical history, especially of: vaginal bleeding of unknown||
1407|155|P|cause, certain cancers (such as breast cancer, cancer of the||
1407|156|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
1407|157|P|heart attack), liver disease, kidney disease, family medical||
1407|158|P|history (especially breast lumps, cancer, blood clots), family or||
1407|159|P|personal history of a certain swelling disorder (angioedema),||
1407|160|P|blood clotting disorders (such as protein C or protein S||
1407|161|P|deficiency), high blood pressure, diabetes, high||
1407|162|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
1407|163|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
1407|164|P|calcium in the blood), a certain hormone problem||
1407|165|P|(hypoparathyroidism), uterus problems (such as fibroids,||
1407|166|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
1407|167|P|headaches, mental/mood disorders (such as dementia, depression),||
1407|168|P|a certain blood disorder (porphyria).||
1407|169|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
1407|170|P|further increases your risk of stroke, blood clots, high blood||
1407|171|P|pressure, and heart attack, especially in women older than 35.||
1407|172|P|   Tell your doctor if you just had or will be having surgery, or||
1407|173|P|if you will be confined to a chair or bed for a long time (such||
1407|174|P|as a long plane flight). These conditions increase your risk of||
1407|175|P|getting blood clots, especially if you are using an estrogen||
1407|176|P|product. You may need to stop this medication for a time or take||
1407|177|P|special precautions.||
1407|178|P|   This drug may cause blotchy, dark areas on your face and skin||
1407|179|P|(melasma). Sunlight may worsen this effect. Limit your time in||
1407|180|P|the sun. Avoid tanning booths and sunlamps. Wear protective||
1407|181|P|clothing when outdoors. Ask your doctor or pharmacist about using||
1407|182|P|sunscreen with this medication. Sunscreen may affect the||
1407|183|P|absorption of this medication if applied on the area of the skin||
1407|184|P|where the medication was applied.||
1407|185|P|   If you are nearsighted or wear contact lenses, you may develop||
1407|186|P|vision problems or trouble wearing your contact lenses. Contact||
1407|187|P|your eye doctor if these problems occur.||
1407|188|P|   This product is not meant for children. Children may be||
1407|189|P|accidentally exposed to this medication by touching someone on||
1407|190|P|the area where the medication was applied. If this occurs, the||
1407|191|P|child may have unwanted side effects. Children should avoid||
1407|192|P|contact with any unclothed area where the medication has been||
1407|193|P|applied. Tell the doctor right away if you notice unexpected||
1407|194|P|signs of puberty in a child such as an increase in breast or||
1407|195|P|nipple size. To decrease this risk, carefully follow all||
1407|196|P|directions for the proper use of this drug.||
1407|197|P|   This medication should not be used during pregnancy. If you||
1407|198|P|become pregnant or think you may be pregnant, tell your doctor||
1407|199|P|right away.||
1407|200|P|   This medication passes into breast milk. Consult your doctor||
1407|201|P|before breastfeeding.||
1407|202|B|||
1407|203|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1407|204|I|medications work or increase your risk for serious side effects.||
1407|205|I|This document does not contain all possible drug interactions.||
1407|206|I|Keep a list of all the products you use (including||
1407|207|I|prescription/nonprescription drugs and herbal products) and share||
1407|208|I|it with your doctor and pharmacist. Do not start, stop, or change||
1407|209|I|the dosage of any medicines without your doctor's approval.||
1407|210|I|   Some products that may interact with this drug include:||
1407|211|I|aromatase inhibitors (such as anastrozole, exemestane,||
1407|212|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
1407|213|I|tamoxifen, toremifene, tranexamic acid.||
1407|214|I|   This medication may interfere with certain lab tests, possibly||
1407|215|I|causing false test results. Make sure lab personnel and all your||
1407|216|I|doctors know you use this drug.||
1407|217|B|||
1407|218|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1407|219|O|has overdosed and has serious symptoms such as passing out or||
1407|220|O|trouble breathing, call 911. Otherwise, call a poison control||
1407|221|O|center right away. US residents can call 1-800-222-1222. Canada||
1407|222|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1407|223|O|include: severe nausea/vomiting, unusual vaginal bleeding.||
1407|224|B|||
1407|225|N|NOTES:  Do not share this medication with others.||
1407|226|N|   Regular complete physical exams which include lab and/or||
1407|227|N|medical tests (such as blood pressure, breast exam/mammogram,||
1407|228|N|pelvic exam, Pap smear) should be done while you are using this||
1407|229|N|medication. Follow your doctor's instructions for examining your||
1407|230|N|breasts, and report any lumps right away. Keep all medical and||
1407|231|N|lab appointments. Consult your doctor for more details.||
1407|232|N|   Preventing or controlling high blood pressure, high||
1407|233|N|cholesterol, and diabetes can help to reduce your chances of||
1407|234|N|heart disease and stroke. Lifestyle changes that can help to||
1407|235|N|control or prevent these diseases include reducing stress, eating||
1407|236|N|a low fat/salt diet, losing weight if overweight, exercising||
1407|237|N|regularly, and stopping smoking. Keep your mind active with||
1407|238|N|mental exercises (such as reading, solving crossword puzzles) to||
1407|239|N|help prevent dementia. Talk to your doctor about lifestyle||
1407|240|N|changes that might benefit you.||
1407|241|N|   Lifestyle changes that may help reduce hot flashes include||
1407|242|N|stopping smoking, dressing lightly or in layers,||
1407|243|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
1407|244|N|reducing stress, and exercising regularly.||
1407|245|B|||
1407|246|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1407|247|D|If it is within 12 hours of the next dose, skip the missed dose.||
1407|248|D|Use your next dose at the regular time. Do not double the dose to||
1407|249|D|catch up.||
1407|250|B|||
1407|251|R|STORAGE:  Store at room temperature away from heat. Do not store||
1407|252|R|near an open flame. Keep all medications away from children and||
1407|253|R|pets.||
1407|254|R|   Do not flush medications down the toilet or pour them into a||
1407|255|R|drain unless instructed to do so. Properly discard this product||
1407|256|R|when it is expired or no longer needed. Consult your pharmacist||
1407|257|R|or local waste disposal company.||
1407|258|B|||
1407|259|A|Information last revised July 2025.||
1407|260|A|Copyright(c) 2025 First Databank, Inc.||
1407|261|B|||
1408|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1408|002|Z|does NOT have all possible information about this product. This||
1408|003|Z|information does not assure that this product is safe, effective,||
1408|004|Z|or appropriate for you. This information is not individual||
1408|005|Z|medical advice and does not substitute for the advice of your||
1408|006|Z|health care professional. Always ask your health care||
1408|007|Z|professional for complete information about this product and your||
1408|008|Z|specific health needs.||
1408|009|B|||
1408|010|T|VARDENAFIL DISINTEGRATING TABLET - ORAL||
1408|011|F|(var-DEN-a-fil)||
1408|012|B|||
1408|013|C|COMMON BRAND NAME(S): Staxyn||
1408|014|B|||
1408|015|U|USES:  Vardenafil is used to treat male sexual function problems||
1408|016|U|(impotence or erectile dysfunction-ED). In combination with||
1408|017|U|sexual stimulation, vardenafil works by increasing blood flow to||
1408|018|U|the penis to help a man get and keep an erection.||
1408|019|U|   This drug does not protect against sexually transmitted||
1408|020|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1408|021|U|an effective barrier method (latex or polyurethane condom/dental||
1408|022|U|dams) during sexual activity will help to decrease your risk of||
1408|023|U|infection.||
1408|024|B|||
1408|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1408|026|H|from your pharmacist before you start taking vardenafil and each||
1408|027|H|time you get a refill. If you have any questions, ask your doctor||
1408|028|H|or pharmacist.||
1408|029|H|   Take this medication as directed by your doctor, usually as||
1408|030|H|needed. Take vardenafil, with or without food, about 1 hour||
1408|031|H|before sexual activity. Do not take more than once daily. Doses||
1408|032|H|should be taken at least 24 hours apart.||
1408|033|H|   Dry your hands before handling this medication. Remove the||
1408|034|H|dose from the blister package right before use. Place the tablet||
1408|035|H|on your tongue and allow it to dissolve completely. Do not crush||
1408|036|H|or split the tablet. This medication should not be taken with||
1408|037|H|liquid.||
1408|038|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1408|039|H|using this medication unless your doctor or pharmacist says you||
1408|040|H|may do so safely. Grapefruit can increase the chance of side||
1408|041|H|effects with this medicine. Ask your doctor or pharmacist for||
1408|042|H|more details.||
1408|043|H|   Vardenafil disintegrating tablets are absorbed differently in||
1408|044|H|the body than vardenafil film-coated tablets. Do not switch from||
1408|045|H|one to the other without consulting your doctor.||
1408|046|H|   Tell your doctor if your condition does not get better.||
1408|047|B|||
1408|048|S|SIDE EFFECTS:  Headache, flushing, or dizziness may occur. Vision||
1408|049|S|changes such as increased sensitivity to light, blurred vision,||
1408|050|S|or trouble telling blue and green colors apart may also occur. If||
1408|051|S|any of these effects last or get worse, tell your doctor or||
1408|052|S|pharmacist promptly.||
1408|053|S|   To reduce the risk of dizziness and lightheadedness, get up||
1408|054|S|slowly when rising from a sitting or lying position.||
1408|055|S|   Remember that this medication has been prescribed because your||
1408|056|S|doctor has judged that the benefit to you is greater than the||
1408|057|S|risk of side effects. Many people using this medication do not||
1408|058|S|have serious side effects.||
1408|059|S|   Sexual activity may put extra strain on your heart, especially||
1408|060|S|if you have heart problems. If you have heart problems and||
1408|061|S|experience any of these serious side effects while having sex,||
1408|062|S|stop and get medical help right away: severe dizziness, fainting,||
1408|063|S|chest/jaw/left arm pain, nausea.||
1408|064|S|   Rarely, sudden decreased vision, including permanent||
1408|065|S|blindness, in one or both eyes (NAION) may occur. If this serious||
1408|066|S|problem occurs, stop taking vardenafil and get medical help right||
1408|067|S|away. You have a slightly greater chance of developing NAION if||
1408|068|S|you have heart disease, diabetes, high cholesterol, certain other||
1408|069|S|eye problems ("crowded disk"), high blood pressure, if you are||
1408|070|S|over 50, or if you smoke.||
1408|071|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
1408|072|S|ringing in the ears and dizziness, may occur. Stop taking||
1408|073|S|vardenafil and get medical help right away if these effects||
1408|074|S|occur.||
1408|075|S|   In the rare event you have a painful or prolonged erection||
1408|076|S|lasting 4 or more hours, stop using this drug and get medical||
1408|077|S|help right away, or permanent problems could occur.||
1408|078|S|   Get medical help right away if you have any very serious side||
1408|079|S|effects, including: seizures, temporary memory loss.||
1408|080|S|   A very serious allergic reaction to this drug is rare.||
1408|081|S|However, get medical help right away if you notice any symptoms||
1408|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1408|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1408|084|S|breathing.||
1408|085|S|   This is not a complete list of possible side effects. If you||
1408|086|S|notice other effects not listed above, contact your doctor or||
1408|087|S|pharmacist.||
1408|088|S|   In the US -||
1408|089|S|   Call your doctor for medical advice about side effects. You||
1408|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1408|091|S|www.fda.gov/medwatch.||
1408|092|S|   In Canada - Call your doctor for medical advice about side||
1408|093|S|effects. You may report side effects to Health Canada at||
1408|094|S|1-866-234-2345.||
1408|095|B|||
1408|096|P|PRECAUTIONS:  Before taking vardenafil, tell your doctor or||
1408|097|P|pharmacist if you are allergic to it; or if you have any other||
1408|098|P|allergies. This product may contain inactive ingredients, which||
1408|099|P|can cause allergic reactions or other problems. Talk to your||
1408|100|P|pharmacist for more details.||
1408|101|P|   Before using this medication, tell your doctor or pharmacist||
1408|102|P|your medical history, especially of: heart problems (such as||
1408|103|P|heart attack or life-threatening irregular heartbeat in the past||
1408|104|P|6 months, chest pain/angina, heart failure), stroke in the past 6||
1408|105|P|months, kidney disease (dialysis), liver disease, high or low||
1408|106|P|blood pressure, dehydration, penis conditions (such as||
1408|107|P|angulation, fibrosis/scarring, Peyronie's disease), history of||
1408|108|P|painful/prolonged erection (priapism), conditions that may||
1408|109|P|increase the risk of priapism (such as sickle cell anemia,||
1408|110|P|leukemia, multiple myeloma), eye problems (such as retinitis||
1408|111|P|pigmentosa, sudden decreased vision, NAION), bleeding disorders,||
1408|112|P|active stomach ulcers.||
1408|113|P|   This drug may make you dizzy or cause vision changes. Alcohol||
1408|114|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
1408|115|P|use machinery, or do anything that needs alertness or clear||
1408|116|P|vision until you can do it safely. Limit alcoholic beverages.||
1408|117|P|Talk to your doctor if you are using marijuana (cannabis).||
1408|118|P|   This medication may contain aspartame. If you have||
1408|119|P|phenylketonuria (PKU) or any other condition that requires you to||
1408|120|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
1408|121|P|doctor or pharmacist about using this medication safely.||
1408|122|P|   Before having surgery, tell your doctor or dentist about all||
1408|123|P|the products you use (including prescription drugs,||
1408|124|P|nonprescription drugs, and herbal products).||
1408|125|P|   This medication is not usually used in women. It is unlikely||
1408|126|P|to be used during pregnancy or breastfeeding. Consult your doctor||
1408|127|P|if you have any questions about this medication.||
1408|128|B|||
1408|129|I|DRUG INTERACTIONS:  See also How to Use section.||
1408|130|I|   Drug interactions may change how your medications work or||
1408|131|I|increase your risk for serious side effects. This document does||
1408|132|I|not contain all possible drug interactions. Keep a list of all||
1408|133|I|the products you use (including prescription/nonprescription||
1408|134|I|drugs and herbal products) and share it with your doctor and||
1408|135|I|pharmacist. Do not start, stop, or change the dosage of any||
1408|136|I|medicines without your doctor's approval.||
1408|137|I|   Some products that may interact with this drug are: riociguat,||
1408|138|I|vericiguat.||
1408|139|I|   Vardenafil can cause a serious drop in your blood pressure||
1408|140|I|when used with nitrates, which can lead to dizziness, fainting,||
1408|141|I|and rarely heart attack or stroke. Do not use vardenafil with any||
1408|142|I|of the following: certain drugs used to treat chest pain/angina||
1408|143|I|(nitrates such as nitroglycerin, isosorbide), recreational drugs||
1408|144|I|called "poppers" containing amyl or butyl nitrite.||
1408|145|I|   If you are also taking an alpha blocker medication (such as||
1408|146|I|doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high||
1408|147|I|blood pressure, your blood pressure may get too low which can||
1408|148|I|lead to dizziness or fainting. To manage this drug interaction,||
1408|149|I|you should not start vardenafil treatment with the disintegrating||
1408|150|I|tablet. Your doctor will start treatment with a lower dose of the||
1408|151|I|regular vardenafil tablets first to minimize your risk of low||
1408|152|I|blood pressure, and then may direct you to switch to vardenafil||
1408|153|I|disintegrating tablets later.||
1408|154|I|   Other medications can affect the removal of vardenafil from||
1408|155|I|your body, which may affect how vardenafil works. Examples||
1408|156|I|include azole antifungals (such as itraconazole, ketoconazole),||
1408|157|I|cobicistat, macrolide antibiotics (such as clarithromycin,||
1408|158|I|erythromycin), ritonavir, among others.||
1408|159|I|   Do not take this medication with any other product that||
1408|160|I|contains vardenafil or other similar medications used to treat||
1408|161|I|erectile dysfunction-ED or pulmonary hypertension (such as||
1408|162|I|sildenafil, tadalafil).||
1408|163|B|||
1408|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1408|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1408|166|O|poison control center right away. US residents can call||
1408|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1408|168|O|Symptoms of overdose may include: back/muscle pain, abnormal||
1408|169|O|vision.||
1408|170|B|||
1408|171|N|NOTES:  Do not share this medication with others.||
1408|172|B|||
1408|173|D|MISSED DOSE:  Not applicable.||
1408|174|B|||
1408|175|R|STORAGE:  Store in the original package at room temperature away||
1408|176|R|from light and moisture. Do not store in the bathroom. Keep all||
1408|177|R|medications away from children and pets.||
1408|178|R|   Do not flush medications down the toilet or pour them into a||
1408|179|R|drain unless instructed to do so. Properly discard this product||
1408|180|R|when it is expired or no longer needed. Consult your pharmacist||
1408|181|R|or local waste disposal company.||
1408|182|B|||
1408|183|A|Information last revised October 2025.||
1408|184|A|Copyright(c) 2025 First Databank, Inc.||
1408|185|B|||
1409|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1409|002|Z|does NOT have all possible information about this product. This||
1409|003|Z|information does not assure that this product is safe, effective,||
1409|004|Z|or appropriate for you. This information is not individual||
1409|005|Z|medical advice and does not substitute for the advice of your||
1409|006|Z|health care professional. Always ask your health care||
1409|007|Z|professional for complete information about this product and your||
1409|008|Z|specific health needs.||
1409|009|B|||
1409|010|T|TAPENTADOL EXTENDED-RELEASE - ORAL||
1409|011|F|(ta-PEN-ta-dol)||
1409|012|B|||
1409|013|C|COMMON BRAND NAME(S): Nucynta ER||
1409|014|B|||
1409|015|W|WARNING:  Tapentadol has a risk for abuse and addiction, which||
1409|016|W|can lead to overdose and death. Tapentadol may also cause severe,||
1409|017|W|possibly fatal, breathing problems. To lower your risk, your||
1409|018|W|doctor should have you take the smallest dose of tapentadol that||
1409|019|W|works, and take it for the shortest possible time. See also How||
1409|020|W|to Use section for more information about addiction.||
1409|021|W|   Ask your doctor or pharmacist if you should have medication||
1409|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1409|023|W|Teach your family or household members about the signs of an||
1409|024|W|opioid overdose and how to treat it.||
1409|025|W|   The risk for severe breathing problems is higher when you||
1409|026|W|start this medication and after a dose increase, or if you take||
1409|027|W|the wrong dose/strength. Taking this medication with alcohol or||
1409|028|W|other drugs that can cause drowsiness or breathing problems may||
1409|029|W|cause very serious side effects, including death. Be sure you||
1409|030|W|know how to take tapentadol and what other drugs you should avoid||
1409|031|W|taking with it. See also Drug Interactions section. Get medical||
1409|032|W|help right away if any of these very serious side effects occur:||
1409|033|W|slow/shallow breathing, unusual lightheadedness, severe||
1409|034|W|drowsiness/dizziness, difficulty waking up.||
1409|035|W|   Do not crush, break, chew, or dissolve this medication. Also,||
1409|036|W|do not drink alcohol or use any product that contains alcohol||
1409|037|W|while taking this medication. Drinking alcohol with this||
1409|038|W|medication or taking crushed, broken, chewed, or dissolved forms||
1409|039|W|of extended-release tapentadol could cause serious (possibly||
1409|040|W|fatal) overdose.||
1409|041|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1409|042|W|or abuse. If someone accidentally swallows this drug, get medical||
1409|043|W|help right away.||
1409|044|W|   Before using this medication, women of childbearing age should||
1409|045|W|talk with their doctor(s) about the risks and benefits. Tell your||
1409|046|W|doctor if you are pregnant or if you plan to become pregnant.||
1409|047|W|During pregnancy, this medication should be used only when||
1409|048|W|clearly needed. It may slightly increase the risk of birth||
1409|049|W|defects if used during the first two months of pregnancy. Also,||
1409|050|W|using it for a long time or in high doses near the expected||
1409|051|W|delivery date may harm the unborn baby. To lessen the risk, take||
1409|052|W|the smallest effective dose for the shortest possible time.||
1409|053|W|Babies born to mothers who use this drug for a long time may||
1409|054|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1409|055|W|doctor right away if you notice any symptoms in your newborn baby||
1409|056|W|such as crying that doesn't stop, slow/shallow breathing,||
1409|057|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1409|058|W|difficulty gaining weight.||
1409|059|B|||
1409|060|U|USES:  This medication is used to help relieve ongoing severe||
1409|061|U|pain. Tapentadol is an opioid pain reliever. It acts on certain||
1409|062|U|centers in the brain to give you pain relief. Tapentadol may also||
1409|063|U|be used to help relieve nerve pain (peripheral neuropathy) in||
1409|064|U|people with diabetes.||
1409|065|U|   Do not use this medication to relieve pain that is mild or||
1409|066|U|that will go away in a few days. This medication is not for||
1409|067|U|occasional ("as needed") use.||
1409|068|B|||
1409|069|H|HOW TO USE:  See also Warning section.||
1409|070|H|   Read the Medication Guide provided by your pharmacist before||
1409|071|H|you start taking tapentadol and each time you get a refill. If||
1409|072|H|you have any questions, consult your doctor or pharmacist.||
1409|073|H|   Take this medication by mouth with or without food as directed||
1409|074|H|by your doctor, usually twice a day (about 12 hours apart). Take||
1409|075|H|this medication on a regular schedule as directed by your doctor,||
1409|076|H|not as needed for sudden (breakthrough) pain. Take this||
1409|077|H|medication with enough water to make sure that you completely||
1409|078|H|swallow the tablet. If you have nausea, it may help to take this||
1409|079|H|drug with food. Ask your doctor or pharmacist about other ways to||
1409|080|H|decrease nausea (such as lying down for 1 to 2 hours with as||
1409|081|H|little head movement as possible).||
1409|082|H|   Swallow the tablet whole. Do not crush, break, chew, or||
1409|083|H|dissolve the tablet. Doing so can release all of the drug at||
1409|084|H|once, increasing the risk of side effects.||
1409|085|H|   The dosage is based on your medical condition and response to||
1409|086|H|treatment. Do not increase your dose, take the medication more||
1409|087|H|often, or take it for a longer time than prescribed. Properly||
1409|088|H|stop the medication when so directed.||
1409|089|H|   Before you start using this medication, ask your doctor or||
1409|090|H|pharmacist if you should stop or change how you use your other||
1409|091|H|opioid medication(s). Other pain relievers (such as||
1409|092|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1409|093|H|or pharmacist about using tapentadol safely with other drugs.||
1409|094|H|   Suddenly stopping this medication may cause withdrawal,||
1409|095|H|especially if you have used it for a long time or in high doses.||
1409|096|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1409|097|H|Tell your doctor or pharmacist right away if you have any||
1409|098|H|withdrawal symptoms such as restlessness, mental/mood changes||
1409|099|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1409|100|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1409|101|H|aches, or sudden changes in behavior.||
1409|102|H|   When this medication is used for a long time, it may not work||
1409|103|H|as well. Talk with your doctor if this medication stops working||
1409|104|H|well.||
1409|105|H|   Though it helps many people, this medication may sometimes||
1409|106|H|cause addiction. This risk may be higher if you have a||
1409|107|H|mental/mood disorder or a substance use disorder (such as overuse||
1409|108|H|of or addiction to drugs/alcohol). Take this medication exactly||
1409|109|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1409|110|H|pharmacist for more details.||
1409|111|H|   Tell your doctor if your pain does not get better or if it||
1409|112|H|gets worse, or if you have any new pain.||
1409|113|B|||
1409|114|S|SIDE EFFECTS:  See also Warning section.||
1409|115|S|   Nausea, vomiting, constipation, dizziness, drowsiness, dry||
1409|116|S|mouth, increased sweating, or tiredness may occur. If any of||
1409|117|S|these effects last or get worse, tell your doctor or pharmacist||
1409|118|S|promptly.||
1409|119|S|   To prevent constipation, eat dietary fiber, drink enough||
1409|120|S|water, and exercise. You may also need to take a laxative. Ask||
1409|121|S|your pharmacist which type of laxative is right for you.||
1409|122|S|   To reduce the risk of dizziness and lightheadedness, get up||
1409|123|S|slowly when rising from a sitting or lying position.||
1409|124|S|   Remember that this medication has been prescribed because your||
1409|125|S|doctor has judged that the benefit to you is greater than the||
1409|126|S|risk of side effects. Many people using this medication do not||
1409|127|S|have serious side effects.||
1409|128|S|   Tell your doctor right away if you have any serious side||
1409|129|S|effects, including: confusion, interrupted breathing during sleep||
1409|130|S|(sleep apnea), severe stomach/abdominal pain, difficulty||
1409|131|S|urinating, signs of your adrenal glands not working well (such as||
1409|132|S|loss of appetite, unusual tiredness, weight loss), trouble||
1409|133|S|swallowing.||
1409|134|S|   Get medical help right away if you have any serious side||
1409|135|S|effects, including: fainting, seizure, slow/shallow breathing,||
1409|136|S|severe drowsiness/difficulty waking up.||
1409|137|S|   This medication may increase serotonin and rarely cause a very||
1409|138|S|serious condition called serotonin syndrome/toxicity. The risk||
1409|139|S|increases if you are also taking other drugs that increase||
1409|140|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1409|141|S|take (see Drug Interactions section). Get medical help right away||
1409|142|S|if you develop some of the following symptoms: fast heartbeat,||
1409|143|S|hallucinations, loss of coordination, severe dizziness, severe||
1409|144|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1409|145|S|unusual agitation/restlessness.||
1409|146|S|   A very serious allergic reaction to this drug is rare.||
1409|147|S|However, get medical help right away if you notice any symptoms||
1409|148|S|of a serious allergic reaction, including: rash, itching/swelling||
1409|149|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1409|150|S|breathing.||
1409|151|S|   This is not a complete list of possible side effects. If you||
1409|152|S|notice other effects not listed above, contact your doctor or||
1409|153|S|pharmacist.||
1409|154|S|   In the US -||
1409|155|S|   Call your doctor for medical advice about side effects. You||
1409|156|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1409|157|S|www.fda.gov/medwatch.||
1409|158|S|   In Canada - Call your doctor for medical advice about side||
1409|159|S|effects. You may report side effects to Health Canada at||
1409|160|S|1-866-234-2345.||
1409|161|B|||
1409|162|P|PRECAUTIONS:  Before taking tapentadol, tell your doctor or||
1409|163|P|pharmacist if you are allergic to it; or if you have any other||
1409|164|P|allergies. This product may contain inactive ingredients, which||
1409|165|P|can cause allergic reactions or other problems. Talk to your||
1409|166|P|pharmacist for more details.||
1409|167|P|   Before using this medication, tell your doctor or pharmacist||
1409|168|P|your medical history, especially of: brain disorders (such as||
1409|169|P|head injury, tumor, seizures), breathing problems (such as||
1409|170|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1409|171|P|kidney disease, liver disease, disease of the pancreas (such as||
1409|172|P|pancreatitis), gallbladder disease, mental/mood disorders (such||
1409|173|P|as confusion, depression, thoughts of suicide), personal or||
1409|174|P|family history of a substance use disorder (such as overuse of or||
1409|175|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
1409|176|P|blockage, constipation, diarrhea due to infection, paralytic||
1409|177|P|ileus), difficulty urinating (such as due to enlarged prostate).||
1409|178|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1409|179|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1409|180|P|machinery, or do anything that needs alertness until you can do||
1409|181|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1409|182|P|are using marijuana (cannabis). (See also Warning section).||
1409|183|P|   Before having surgery, tell your doctor or dentist about all||
1409|184|P|the products you use (including prescription drugs,||
1409|185|P|nonprescription drugs, and herbal products).||
1409|186|P|   Older adults may be more sensitive to the side effects of this||
1409|187|P|drug, especially slow/shallow breathing, constipation, confusion,||
1409|188|P|dizziness, and drowsiness.||
1409|189|P|   During pregnancy, this medication should be used only when||
1409|190|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1409|191|P|benefits with your doctor. (See also Warning section.)||
1409|192|P|   It is unknown if this medication passes into breast milk. It||
1409|193|P|may have undesirable effects on a nursing infant. Tell the doctor||
1409|194|P|right away if your baby develops unusual sleepiness, difficulty||
1409|195|P|feeding, or trouble breathing. Consult your doctor before||
1409|196|P|breastfeeding.||
1409|197|B|||
1409|198|I|DRUG INTERACTIONS:  See also Warning section.||
1409|199|I|   Drug interactions may change how your medications work or||
1409|200|I|increase your risk for serious side effects. This document does||
1409|201|I|not contain all possible drug interactions. Keep a list of all||
1409|202|I|the products you use (including prescription/nonprescription||
1409|203|I|drugs and herbal products) and share it with your doctor and||
1409|204|I|pharmacist. Do not start, stop, or change the dosage of any||
1409|205|I|medicines without your doctor's approval.||
1409|206|I|   Some products that may interact with this drug include:||
1409|207|I|certain pain medications (mixed opioid agonist-antagonists such||
1409|208|I|as butorphanol, nalbuphine, pentazocine), naltrexone, products||
1409|209|I|that contain alcohol (such as cough-and-cold syrups),||
1409|210|I|samidorphan.||
1409|211|I|   Taking MAO inhibitors with this medication may cause a serious||
1409|212|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1409|213|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1409|214|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1409|215|I|selegiline, tranylcypromine) during treatment with this||
1409|216|I|medication. Most MAO inhibitors should also not be taken for two||
1409|217|I|weeks before treatment with this medication. Ask your doctor when||
1409|218|I|to start or stop taking this medication.||
1409|219|I|   The risk of serotonin syndrome/toxicity increases if you are||
1409|220|I|also taking other drugs that increase serotonin. Examples include||
1409|221|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1409|222|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1409|223|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1409|224|I|serotonin syndrome/toxicity may be more likely when you start or||
1409|225|I|increase the dose of these drugs.||
1409|226|I|   The risk of serious side effects (such as slow/shallow||
1409|227|I|breathing, severe drowsiness/dizziness) may be increased if this||
1409|228|I|medication is taken with other products that may also cause||
1409|229|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1409|230|I|if you are taking other products such as other opioid pain or||
1409|231|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1409|232|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1409|233|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1409|234|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1409|235|I|cetirizine, diphenhydramine).||
1409|236|I|   Check the labels on all your medicines (such as allergy or||
1409|237|I|cough-and-cold products) because they may contain ingredients||
1409|238|I|that cause drowsiness. Ask your pharmacist about using those||
1409|239|I|products safely.||
1409|240|I|   This medication may interfere with certain lab tests (such as||
1409|241|I|amylase/lipase levels), possibly causing false test results. Make||
1409|242|I|sure lab personnel and all your doctors know you use this drug.||
1409|243|B|||
1409|244|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1409|245|O|as passing out or trouble breathing, give them naloxone or||
1409|246|O|nalmefene if available, then call 911. If the person is awake and||
1409|247|O|has no symptoms, call a poison control center right away. US||
1409|248|O|residents can call 1-800-222-1222. Canada residents can call||
1409|249|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1409|250|O|breathing, slow heartbeat, seizures, coma.||
1409|251|B|||
1409|252|N|NOTES:  Do not share this medication with others. Sharing it is||
1409|253|N|against the law.||
1409|254|N|   This medication has been prescribed for your current condition||
1409|255|N|only. Do not use it later for another condition unless your||
1409|256|N|doctor directs you to do so. A different medication may be||
1409|257|N|necessary in that case.||
1409|258|B|||
1409|259|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1409|260|D|remember. If it is near the time of the next dose, skip the||
1409|261|D|missed dose. Take your next dose at the regular time. Do not||
1409|262|D|double the dose to catch up.||
1409|263|B|||
1409|264|R|STORAGE:  Store at room temperature away from light and moisture.||
1409|265|R|Do not store in the bathroom. Keep all medications away from||
1409|266|R|children and pets. See also Warning section.||
1409|267|R|   Do not flush medications down the toilet or pour them into a||
1409|268|R|drain unless instructed to do so. Properly discard this product||
1409|269|R|when it is expired or no longer needed. For more details, read||
1409|270|R|the Medication Guide, or consult your pharmacist or local waste||
1409|271|R|disposal company.||
1409|272|B|||
1409|273|A|Information last revised August 2025.||
1409|274|A|Copyright(c) 2025 First Databank, Inc.||
1409|275|B|||
1410|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1410|002|Z|does NOT have all possible information about this product. This||
1410|003|Z|information does not assure that this product is safe, effective,||
1410|004|Z|or appropriate for you. This information is not individual||
1410|005|Z|medical advice and does not substitute for the advice of your||
1410|006|Z|health care professional. Always ask your health care||
1410|007|Z|professional for complete information about this product and your||
1410|008|Z|specific health needs.||
1410|009|B|||
1410|010|T|VANDETANIB - ORAL||
1410|011|F|(van-DET-a-nib)||
1410|012|B|||
1410|013|C|COMMON BRAND NAME(S): Caprelsa||
1410|014|B|||
1410|015|W|WARNING:  Vandetanib may cause a condition that affects the heart||
1410|016|W|rhythm (QT prolongation). QT prolongation can rarely cause||
1410|017|W|serious (rarely fatal) fast/irregular heartbeat and other||
1410|018|W|symptoms (such as severe dizziness, fainting). Get medical help||
1410|019|W|right away if you have any of these symptoms.||
1410|020|W|   The risk of QT prolongation may be increased if you have||
1410|021|W|certain medical conditions or are taking other drugs that may||
1410|022|W|affect the heart rhythm (see also Drug Interactions). Do not use||
1410|023|W|vandetanib if you have a certain heart problem (long QT||
1410|024|W|syndrome). Before using vandetanib, tell your doctor or||
1410|025|W|pharmacist of all the drugs you take and if you have any of the||
1410|026|W|following conditions: certain heart problems (heart failure, slow||
1410|027|W|heartbeat, QT prolongation/long QT syndrome), family history of||
1410|028|W|certain heart problems (QT prolongation/long QT syndrome, sudden||
1410|029|W|cardiac death).||
1410|030|W|   Vandetanib should not be used in people with low levels of||
1410|031|W|calcium, potassium, or magnesium in the blood. Low levels of||
1410|032|W|these minerals may also increase your risk of QT prolongation.||
1410|033|W|This risk may increase if you use certain drugs (such as||
1410|034|W|diuretics/"water pills") or if you have conditions such as severe||
1410|035|W|sweating, diarrhea, or vomiting.||
1410|036|W|   To lower your risk, your doctor will check your mineral levels||
1410|037|W|with a blood test and your heart with a test (EKG) before and||
1410|038|W|periodically during treatment. Low mineral levels should be||
1410|039|W|corrected before you start treatment. If you develop QT||
1410|040|W|prolongation, your doctor may stop treatment for a while and||
1410|041|W|restart it at a lower dose, and check your EKG again.||
1410|042|W|   Since vandetanib stays in your body for a long time, it may||
1410|043|W|take a while for side effects such as QT prolongation to go away||
1410|044|W|after you stop taking it. Discuss the risks and benefits of||
1410|045|W|treatment with your doctor.||
1410|046|B|||
1410|047|U|USES:  This medication is used to treat thyroid cancer (medullary||
1410|048|U|type). It works by slowing or stopping the growth of cancer||
1410|049|U|cells. Vandetanib belongs to a class of drugs known as tyrosine||
1410|050|U|kinase inhibitors.||
1410|051|B|||
1410|052|H|HOW TO USE:  Read the Medication Guide provided by your||
1410|053|H|pharmacist before you start taking vandetanib and each time you||
1410|054|H|get a refill. If you have any questions, ask your doctor or||
1410|055|H|pharmacist.||
1410|056|H|   Take this medication by mouth with or without food as directed||
1410|057|H|by your doctor, usually once daily. Swallow this medication||
1410|058|H|whole. If you cannot swallow the tablets whole, place your dose||
1410|059|H|in a glass of non-carbonated water (2 ounces or 60 milliliters)||
1410|060|H|and stir for about 10 minutes until the tablet has broken apart.||
1410|061|H|Note that the tablet will not completely dissolve. Do not use||
1410|062|H|other liquids. Swallow the mixture right away. Rinse the glass||
1410|063|H|with 4 ounces (120 milliliters) of non-carbonated water, stir to||
1410|064|H|mix, and then swallow.||
1410|065|H|   Do not break or crush the tablets. Do not touch the dust or||
1410|066|H|powder from this medication. Since this drug can be absorbed||
1410|067|H|through the skin and lungs and may harm an unborn baby, women who||
1410|068|H|are pregnant or who may become pregnant should not handle this||
1410|069|H|medication or breathe the dust from the tablets. If contact||
1410|070|H|occurs, wash the area thoroughly.||
1410|071|H|   The dosage is based on your medical condition and response to||
1410|072|H|treatment.||
1410|073|H|   Take this medication regularly to get the most benefit from||
1410|074|H|it. To help you remember, take it at the same time each day.||
1410|075|H|   Tell your doctor if your condition gets worse.||
1410|076|B|||
1410|077|S|SIDE EFFECTS:  See also Warning section.||
1410|078|S|   Nausea, decreased appetite, changes in taste, dry mouth,||
1410|079|S|stomach pain, vomiting, diarrhea, headache, or blurred vision may||
1410|080|S|occur. Nail problems (such as nail bed||
1410|081|S|swelling/tenderness/infection) may also occur. If any of these||
1410|082|S|effects last or get worse, tell your doctor or pharmacist||
1410|083|S|promptly. If you have diarrhea or vomiting that is severe or||
1410|084|S|doesn't stop, your doctor may need to check your blood mineral||
1410|085|S|levels and adjust your vandetanib treatment.||
1410|086|S|   Temporary hair loss may occur. Normal hair growth should||
1410|087|S|return after treatment has ended.||
1410|088|S|   Remember that this medication has been prescribed because your||
1410|089|S|doctor has judged that the benefit to you is greater than the||
1410|090|S|risk of side effects. Many people using this medication do not||
1410|091|S|have serious side effects.||
1410|092|S|   Vandetanib can commonly cause a rash that is usually not||
1410|093|S|serious. Mild to moderate skin reactions include acne, dry skin,||
1410|094|S|or a mildly irritated/red/itchy rash. However, you may not be||
1410|095|S|able to tell it apart from a rare rash that could be a sign of a||
1410|096|S|severe reaction. Get medical help right away if you develop any||
1410|097|S|rash.||
1410|098|S|   Tell your doctor right away if you have any serious side||
1410|099|S|effects, including: redness/pain/swelling of the palms of the||
1410|100|S|hands or soles of the feet, depression, jaw pain, slow wound||
1410|101|S|healing, signs of heart failure (such as shortness of breath,||
1410|102|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
1410|103|S|gain), signs of an underactive thyroid (such as weight gain, cold||
1410|104|S|intolerance, slow heartbeat, constipation, unusual tiredness),||
1410|105|S|signs of kidney problems (such as change in the amount of urine).||
1410|106|S|   This medication may raise your blood pressure. Check your||
1410|107|S|blood pressure regularly and tell your doctor if the results are||
1410|108|S|high.||
1410|109|S|   Vandetanib may cause a rare (possibly fatal) type of breathing||
1410|110|S|problem (interstitial lung disease). Get medical help right away||
1410|111|S|if you have sudden/worsening shortness of breath, cough, or||
1410|112|S|fever.||
1410|113|S|   Vandetanib may also rarely cause a serious brain condition.||
1410|114|S|Get medical help right away if you develop headaches, seizures,||
1410|115|S|vision changes, confusion, or problems thinking.||
1410|116|S|   Get medical help right away if you have any serious side||
1410|117|S|effects, including: signs of bleeding (such as bloody vomit,||
1410|118|S|vomit that looks like coffee grounds, black/bloody stools), signs||
1410|119|S|of a stroke (such as weakness on one side of the body, trouble||
1410|120|S|speaking, sudden vision changes, confusion), sudden/severe pain||
1410|121|S|in the stomach/chest/back.||
1410|122|S|   A very serious allergic reaction to this drug is rare.||
1410|123|S|However, get medical help right away if you notice any symptoms||
1410|124|S|of a serious allergic reaction, including: rash, blisters,||
1410|125|S|peeling skin, itching/swelling (especially of the||
1410|126|S|face/tongue/throat), severe dizziness, trouble breathing, fever,||
1410|127|S|joint pain.||
1410|128|S|   This is not a complete list of possible side effects. If you||
1410|129|S|notice other effects not listed above, contact your doctor or||
1410|130|S|pharmacist.||
1410|131|S|   In the US -||
1410|132|S|   Call your doctor for medical advice about side effects. You||
1410|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1410|134|S|www.fda.gov/medwatch.||
1410|135|S|   In Canada - Call your doctor for medical advice about side||
1410|136|S|effects. You may report side effects to Health Canada at||
1410|137|S|1-866-234-2345.||
1410|138|B|||
1410|139|P|PRECAUTIONS:  See also Warning section.||
1410|140|P|   Before taking vandetanib, tell your doctor or pharmacist if||
1410|141|P|you are allergic to it; or if you have any other allergies. This||
1410|142|P|product may contain inactive ingredients, which can cause||
1410|143|P|allergic reactions or other problems. Talk to your pharmacist for||
1410|144|P|more details.||
1410|145|P|   Before using this medication, tell your doctor or pharmacist||
1410|146|P|your medical history, especially of: kidney disease, high blood||
1410|147|P|pressure, recent bleeding (including recently coughing up blood),||
1410|148|P|blood vessel problems (such as an aneurysm or a tear/break in the||
1410|149|P|aorta or other blood vessels), recent surgery/injury.||
1410|150|P|   This drug may cause blurred vision. Do not drive, use||
1410|151|P|machinery, or do anything that needs clear vision until you can||
1410|152|P|do it safely.||
1410|153|P|   This medication may make you more sensitive to the sun. Limit||
1410|154|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1410|155|P|sunscreen and wear protective clothing when outdoors. Get medical||
1410|156|P|help right away if you get sunburned or have skin||
1410|157|P|blisters/redness. Follow these instructions while taking||
1410|158|P|vandetanib and for 4 months after stopping treatment.||
1410|159|P|   Some people taking vandetanib may have serious jawbone||
1410|160|P|problems. Your doctor should check your mouth before you start||
1410|161|P|this medication. Tell your dentist that you are taking this||
1410|162|P|medication before you have any dental work done. To help prevent||
1410|163|P|jawbone problems, have regular dental exams and learn how to keep||
1410|164|P|your teeth and gums healthy. If you have jaw pain, tell your||
1410|165|P|doctor and dentist right away.||
1410|166|P|   Before having surgery, tell your doctor or dentist about all||
1410|167|P|the products you use (including prescription drugs,||
1410|168|P|nonprescription drugs, and herbal products).||
1410|169|P|   This medication may cause wounds to heal slowly or poorly.||
1410|170|P|Your doctor or dentist may tell you to temporarily stop treatment||
1410|171|P|with this medication at least 1 month before surgery or a dental||
1410|172|P|procedure. Ask your doctor or dentist for specific instructions||
1410|173|P|about when to stop and when to restart treatment with vandetanib.||
1410|174|P|Tell your doctor/dentist right away if you have wounds that are||
1410|175|P|not healing well.||
1410|176|P|   Older adults may be more sensitive to the side effects of this||
1410|177|P|drug, especially QT prolongation (see also Warning section).||
1410|178|P|   Since this drug can be absorbed through the skin and lungs and||
1410|179|P|may harm an unborn baby, women who are pregnant or who may become||
1410|180|P|pregnant should not handle this medication or breathe the dust||
1410|181|P|from the tablets.||
1410|182|P|   Tell your doctor if you are pregnant or plan to become||
1410|183|P|pregnant. You should not become pregnant while using vandetanib.||
1410|184|P|Vandetanib may harm an unborn baby. Your doctor should order a||
1410|185|P|pregnancy test before you start this medication. Men and women||
1410|186|P|using this medication should ask about reliable forms of birth||
1410|187|P|control during treatment and for 4 months after the last dose. If||
1410|188|P|you or your partner becomes pregnant, talk to your doctor right||
1410|189|P|away about the risks and benefits of this medication.||
1410|190|P|   It is unknown if this drug passes into breast milk. Because of||
1410|191|P|the possible risk to the infant, breastfeeding is not recommended||
1410|192|P|while using this drug and for 4 months after the last dose.||
1410|193|P|Consult your doctor before breastfeeding.||
1410|194|B|||
1410|195|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1410|196|I|medications work or increase your risk for serious side effects.||
1410|197|I|This document does not contain all possible drug interactions.||
1410|198|I|Keep a list of all the products you use (including||
1410|199|I|prescription/nonprescription drugs and herbal products) and share||
1410|200|I|it with your doctor and pharmacist. Do not start, stop, or change||
1410|201|I|the dosage of any medicines without your doctor's approval.||
1410|202|I|   Many drugs besides vandetanib may affect the heart rhythm (QT||
1410|203|I|prolongation), including amiodarone, chloroquine, disopyramide,||
1410|204|I|dofetilide, granisetron, haloperidol, methadone, moxifloxacin,||
1410|205|I|pimozide, procainamide, sotalol, macrolide antibiotics (such as||
1410|206|I|clarithromycin), among others.||
1410|207|I|   Other medications can affect the removal of vandetanib from||
1410|208|I|your body, which may affect how vandetanib works. Examples||
1410|209|I|include dexamethasone, St. John's wort, rifamycins (such as||
1410|210|I|rifabutin, rifampin), drugs used to treat seizures (such as||
1410|211|I|carbamazepine, phenytoin, phenobarbital, primidone), among||
1410|212|I|others.||
1410|213|B|||
1410|214|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1410|215|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1410|216|O|poison control center right away. US residents can call||
1410|217|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1410|218|O|Symptoms of overdose may include: rash, diarrhea, high blood||
1410|219|O|pressure.||
1410|220|B|||
1410|221|N|NOTES:  Do not share this medication with others.||
1410|222|N|   Lab and/or medical tests (such as EKG, blood mineral levels||
1410|223|N|including calcium/magnesium/potassium, thyroid function, blood||
1410|224|N|pressure, eye exams) should be done while you are taking this||
1410|225|N|medication. Keep all medical and lab appointments. Consult your||
1410|226|N|doctor for more details.||
1410|227|B|||
1410|228|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1410|229|D|remember. If it is less than 12 hours before the next dose, skip||
1410|230|D|the missed dose. Take your next dose at the regular time. Do not||
1410|231|D|double the dose to catch up.||
1410|232|B|||
1410|233|R|STORAGE:  Store at room temperature away from light and moisture.||
1410|234|R|Do not store in the bathroom. Keep all medications away from||
1410|235|R|children and pets.||
1410|236|R|   Do not flush medications down the toilet or pour them into a||
1410|237|R|drain unless instructed to do so. Properly discard this product||
1410|238|R|when it is expired or no longer needed. Consult your pharmacist||
1410|239|R|or local waste disposal company.||
1410|240|B|||
1410|241|A|Information last revised September 2025.||
1410|242|A|Copyright(c) 2025 First Databank, Inc.||
1410|243|B|||
1412|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1412|002|Z|does NOT have all possible information about this product. This||
1412|003|Z|information does not assure that this product is safe, effective,||
1412|004|Z|or appropriate for you. This information is not individual||
1412|005|Z|medical advice and does not substitute for the advice of your||
1412|006|Z|health care professional. Always ask your health care||
1412|007|Z|professional for complete information about this product and your||
1412|008|Z|specific health needs.||
1412|009|B|||
1412|010|T|GABAPENTIN ENACARBIL SUSTAINED-RELEASE - ORAL||
1412|011|F|(GAB-a-PEN-tin EN-a-KAR-bil)||
1412|012|B|||
1412|013|C|COMMON BRAND NAME(S): Horizant||
1412|014|B|||
1412|015|U|USES:  This medication is used to treat moderate to severe||
1412|016|U|restless legs syndrome. It is also used to relieve nerve pain||
1412|017|U|following shingles (a painful rash due to herpes zoster||
1412|018|U|infection). This condition is called postherpetic neuralgia.||
1412|019|U|Gabapentin enacarbil is changed by your body to gabapentin.||
1412|020|U|Gabapentin belongs to a class of drugs known as anti-seizure or||
1412|021|U|anticonvulsant drugs.||
1412|022|B|||
1412|023|V|OTHER USES:  This section contains uses of this drug that are not||
1412|024|V|listed in the approved professional labeling for the drug but||
1412|025|V|that may be prescribed by your health care professional. Use this||
1412|026|V|drug for a condition that is listed in this section only if it||
1412|027|V|has been so prescribed by your health care professional.||
1412|028|V|   This drug may also be used for seizures and other painful||
1412|029|V|nerve conditions (neuropathic pain).||
1412|030|B|||
1412|031|H|HOW TO USE:  Read the Medication Guide provided by your||
1412|032|H|pharmacist before you start taking gabapentin enacarbil and each||
1412|033|H|time you get a refill. If you have any questions, ask your doctor||
1412|034|H|or pharmacist.||
1412|035|H|   The dosage is based on your medical condition and response to||
1412|036|H|treatment.||
1412|037|H|   For Restless Legs Syndrome: Take this medication by mouth as||
1412|038|H|directed by your doctor, usually once daily with food at about 5||
1412|039|H|PM. This dosing schedule is for people who are awake during the||
1412|040|H|day and asleep during the night. If you need to sleep during the||
1412|041|H|daytime and stay awake at night, talk with your doctor about your||
1412|042|H|schedule before using this medication.||
1412|043|H|   For Postherpetic Nerve Pain: Take this medication by mouth as||
1412|044|H|directed by your doctor, usually once daily with food for several||
1412|045|H|days, then increase to twice a day with food thereafter.||
1412|046|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1412|047|H|Doing so can release all of the drug at once, increasing the risk||
1412|048|H|of side effects.||
1412|049|H|   Take this medication regularly to get the most benefit from||
1412|050|H|it. To help you remember, take it at the same time(s) each day.||
1412|051|H|   Do not increase your dose or use this drug more often or for||
1412|052|H|longer than prescribed. Your condition will not improve any||
1412|053|H|faster, and your risk of side effects will increase.||
1412|054|H|   Do not stop taking this medication without consulting your||
1412|055|H|doctor. Some conditions may become worse when this drug is||
1412|056|H|suddenly stopped. Also, you may experience symptoms such as||
1412|057|H|difficulty sleeping, sweating, nausea, and headache. To prevent||
1412|058|H|these symptoms while you are stopping treatment with this drug,||
1412|059|H|your doctor may reduce your dose gradually. Report any new or||
1412|060|H|worsening symptoms right away.||
1412|061|H|   Different forms of gabapentin (such as immediate-release,||
1412|062|H|sustained-release, enacarbil sustained-release) are absorbed in||
1412|063|H|the body differently. Do not switch from one form to the other||
1412|064|H|without consulting your doctor.||
1412|065|H|   Tell your doctor if your condition does not get better or if||
1412|066|H|it gets worse.||
1412|067|B|||
1412|068|S|SIDE EFFECTS:  Drowsiness, dizziness, loss of coordination, or||
1412|069|S|blurred vision may occur. If any of these effects last or get||
1412|070|S|worse, tell your doctor or pharmacist promptly.||
1412|071|S|   Remember that this medication has been prescribed because your||
1412|072|S|doctor has judged that the benefit to you is greater than the||
1412|073|S|risk of side effects. Many people using this medication do not||
1412|074|S|have serious side effects.||
1412|075|S|   A small number of people who take anticonvulsants for any||
1412|076|S|condition (such as seizure, bipolar disorder, pain) may||
1412|077|S|experience depression, suicidal thoughts/attempts, or other||
1412|078|S|mental/mood problems. These effects may occur even after the||
1412|079|S|medication has been stopped. Tell your doctor right away if you||
1412|080|S|or your family/caregiver notice any unusual/sudden changes in||
1412|081|S|your mood, thoughts, or behavior including signs of depression,||
1412|082|S|suicidal thoughts/attempts, thoughts about harming yourself.||
1412|083|S|   Get medical help right away if you have any very serious side||
1412|084|S|effects, including: slow/shallow breathing.||
1412|085|S|   A very serious allergic reaction to this drug is rare.||
1412|086|S|However, get medical help right away if you notice any symptoms||
1412|087|S|of a serious allergic reaction, including: fever, swollen lymph||
1412|088|S|nodes, rash, itching/swelling (especially of the||
1412|089|S|face/tongue/throat), severe dizziness, trouble breathing.||
1412|090|S|   This is not a complete list of possible side effects. If you||
1412|091|S|notice other effects not listed above, contact your doctor or||
1412|092|S|pharmacist.||
1412|093|S|   In the US -||
1412|094|S|   Call your doctor for medical advice about side effects. You||
1412|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1412|096|S|www.fda.gov/medwatch.||
1412|097|S|   In Canada - Call your doctor for medical advice about side||
1412|098|S|effects. You may report side effects to Health Canada at||
1412|099|S|1-866-234-2345.||
1412|100|B|||
1412|101|P|PRECAUTIONS:  Before taking gabapentin enacarbil, tell your||
1412|102|P|doctor or pharmacist if you are allergic to it; or to gabapentin;||
1412|103|P|or if you have any other allergies. This product may contain||
1412|104|P|inactive ingredients, which can cause allergic reactions or other||
1412|105|P|problems. Talk to your pharmacist for more details.||
1412|106|P|   Before using this medication, tell your doctor or pharmacist||
1412|107|P|your medical history, especially of: kidney disease, mental/mood||
1412|108|P|problems (such as depression, thoughts of suicide), use/abuse of||
1412|109|P|drugs/alcohol, breathing problems (such as COPD).||
1412|110|P|   This drug may make you dizzy or drowsy or blur your vision.||
1412|111|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1412|112|P|drowsy. Do not drive, use machinery, or do anything that needs||
1412|113|P|alertness or clear vision until you can do it safely. Avoid||
1412|114|P|alcoholic beverages. Talk to your doctor if you are using||
1412|115|P|marijuana (cannabis).||
1412|116|P|   Before having surgery, tell your doctor or dentist about all||
1412|117|P|the products you use (including prescription drugs,||
1412|118|P|nonprescription drugs, and herbal products).||
1412|119|P|   Older adults may be more sensitive to the side effects of this||
1412|120|P|drug, especially swelling of the hands/ankles/feet, slow/shallow||
1412|121|P|breathing, dizziness, or loss of coordination. Dizziness and loss||
1412|122|P|of coordination can increase the risk of falling.||
1412|123|P|   During pregnancy, this medication should be used only when||
1412|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
1412|125|P|   Gabapentin passes into breast milk. Consult your doctor before||
1412|126|P|breastfeeding.||
1412|127|B|||
1412|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1412|129|I|medications work or increase your risk for serious side effects.||
1412|130|I|This document does not contain all possible drug interactions.||
1412|131|I|Keep a list of all the products you use (including||
1412|132|I|prescription/nonprescription drugs and herbal products) and share||
1412|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
1412|134|I|the dosage of any medicines without your doctor's approval.||
1412|135|I|   A product that may interact with this drug is: orlistat.||
1412|136|I|   The risk of serious side effects (such as slow/shallow||
1412|137|I|breathing, severe drowsiness/dizziness) may be increased if this||
1412|138|I|medication is taken with other products that may also cause||
1412|139|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1412|140|I|if you are using other products such as opioid pain or cough||
1412|141|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1412|142|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1412|143|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1412|144|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1412|145|I|diphenhydramine).||
1412|146|I|   Check the labels on all your medicines (such as allergy or||
1412|147|I|cough-and-cold products) because they may contain ingredients||
1412|148|I|that cause drowsiness. Ask your pharmacist about using those||
1412|149|I|products safely.||
1412|150|I|   Do not use this medication with other medications that contain||
1412|151|I|gabapentin.||
1412|152|I|   This medication may interfere with certain lab tests (such as||
1412|153|I|urine protein), possibly causing false test results. Make sure||
1412|154|I|lab personnel and all your doctors know you use this drug.||
1412|155|B|||
1412|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1412|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1412|158|O|poison control center right away. US residents can call||
1412|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1412|160|O|Symptoms of overdose may include: severe drowsiness and||
1412|161|O|dizziness.||
1412|162|B|||
1412|163|N|NOTES:  Do not share this medication with others.||
1412|164|B|||
1412|165|D|MISSED DOSE:  For Restless Legs Syndrome: If you miss a dose,||
1412|166|D|skip the missed dose. Take your next dose at the regular time the||
1412|167|D|next day. Do not double the dose to catch up.||
1412|168|D|   For Postherpetic Nerve Pain: If you miss a dose, skip the||
1412|169|D|missed dose. Take your next dose at the regular time. Do not||
1412|170|D|double the dose to catch up.||
1412|171|B|||
1412|172|R|STORAGE:  Store in the original bottle at room temperature away||
1412|173|R|from light and moisture. Do not store in the bathroom. Keep the||
1412|174|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1412|175|R|when not in use. Keep all medications away from children and||
1412|176|R|pets.||
1412|177|R|   Do not flush medications down the toilet or pour them into a||
1412|178|R|drain unless instructed to do so. Properly discard this product||
1412|179|R|when it is expired or no longer needed. Consult your pharmacist||
1412|180|R|or local waste disposal company.||
1412|181|B|||
1412|182|A|Information last revised May 2025.||
1412|183|A|Copyright(c) 2025 First Databank, Inc.||
1412|184|B|||
1413|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1413|002|Z|does NOT have all possible information about this product. This||
1413|003|Z|information does not assure that this product is safe, effective,||
1413|004|Z|or appropriate for you. This information is not individual||
1413|005|Z|medical advice and does not substitute for the advice of your||
1413|006|Z|health care professional. Always ask your health care||
1413|007|Z|professional for complete information about this product and your||
1413|008|Z|specific health needs.||
1413|009|B|||
1413|010|T|LINAGLIPTIN - ORAL||
1413|011|F|(LIN-a-GLIP-tin)||
1413|012|B|||
1413|013|C|COMMON BRAND NAME(S): Tradjenta||
1413|014|B|||
1413|015|U|USES:  Linagliptin is used with a proper diet and exercise||
1413|016|U|program and possibly with other medications to control high blood||
1413|017|U|sugar. It is used by people with type 2 diabetes. Controlling||
1413|018|U|high blood sugar helps prevent kidney damage, blindness, nerve||
1413|019|U|problems, loss of limbs, and sexual function problems. Proper||
1413|020|U|control of diabetes may also lessen your risk of a heart attack||
1413|021|U|or stroke.||
1413|022|U|   Linagliptin is a diabetes drug that works by increasing levels||
1413|023|U|of natural substances called incretins. Incretins help to control||
1413|024|U|blood sugar by increasing insulin release, especially after a||
1413|025|U|meal. They also decrease the amount of sugar your liver makes.||
1413|026|B|||
1413|027|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1413|028|H|Patient Information Leaflet provided by your pharmacist before||
1413|029|H|you start taking linagliptin and each time you get a refill. If||
1413|030|H|you have any questions, ask your doctor or pharmacist.||
1413|031|H|   Take this medication by mouth with or without food as directed||
1413|032|H|by your doctor, usually once daily.||
1413|033|H|   The dosage is based on your medical condition, response to||
1413|034|H|treatment, and other medications you may be taking.||
1413|035|H|   Take this medication regularly to get the most benefit from||
1413|036|H|it. To help you remember, take it at the same time each day.||
1413|037|H|Carefully follow the medication treatment plan, meal plan, and||
1413|038|H|exercise program your doctor has recommended.||
1413|039|H|   Check your blood sugar regularly as directed by your doctor.||
1413|040|H|Keep track of the results, and share them with your doctor. Tell||
1413|041|H|your doctor if your blood sugar measurements are too high or too||
1413|042|H|low. Your dosage/treatment may need to be changed.||
1413|043|B|||
1413|044|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1413|045|S|because your doctor has judged that the benefit to you is greater||
1413|046|S|than the risk of side effects. Many people using this medication||
1413|047|S|do not have serious side effects.||
1413|048|S|   Tell your doctor right away if you have any serious side||
1413|049|S|effects, including: joint pain, unusual skin blisters, signs of||
1413|050|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1413|051|S|unusual tiredness, unusual/sudden weight gain).||
1413|052|S|   Linagliptin does not usually cause low blood sugar||
1413|053|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1413|054|S|prescribed with other diabetes medications, or if you do not get||
1413|055|S|enough calories from food, or if you do unusually heavy exercise.||
1413|056|S|Talk with your doctor or pharmacist about whether the dose of||
1413|057|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1413|058|S|of low blood sugar include sudden sweating, shaking, fast||
1413|059|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1413|060|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1413|061|S|treat low blood sugar. If you don't have these reliable forms of||
1413|062|S|glucose, rapidly raise your blood sugar by eating a quick source||
1413|063|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1413|064|S|juice or non-diet soda. Tell your doctor right away about the||
1413|065|S|reaction and the use of this product. To help prevent low blood||
1413|066|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1413|067|S|Check with your doctor or pharmacist to find out what you should||
1413|068|S|do if you miss a meal.||
1413|069|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1413|070|S|thirst/urination. If these symptoms occur, tell your doctor right||
1413|071|S|away. Your doctor may need to adjust your diabetes medication,||
1413|072|S|exercise program, or diet.||
1413|073|S|   Get medical help right away if you have any very serious side||
1413|074|S|effects, including: signs of disease of the pancreas (such as||
1413|075|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain||
1413|076|S|which may spread to the back).||
1413|077|S|   A very serious allergic reaction to this drug is rare.||
1413|078|S|However, get medical help right away if you notice any symptoms||
1413|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1413|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1413|081|S|breathing.||
1413|082|S|   This is not a complete list of possible side effects. If you||
1413|083|S|notice other effects not listed above, contact your doctor or||
1413|084|S|pharmacist.||
1413|085|S|   In the US -||
1413|086|S|   Call your doctor for medical advice about side effects. You||
1413|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1413|088|S|www.fda.gov/medwatch.||
1413|089|S|   In Canada - Call your doctor for medical advice about side||
1413|090|S|effects. You may report side effects to Health Canada at||
1413|091|S|1-866-234-2345.||
1413|092|B|||
1413|093|P|PRECAUTIONS:  Before taking linagliptin, tell your doctor or||
1413|094|P|pharmacist if you are allergic to it; or if you have any other||
1413|095|P|allergies. This product may contain inactive ingredients, which||
1413|096|P|can cause allergic reactions or other problems. Talk to your||
1413|097|P|pharmacist for more details.||
1413|098|P|   Before using this medication, tell your doctor or pharmacist||
1413|099|P|your medical history, especially of: disease of the pancreas||
1413|100|P|(pancreatitis), stones in your gallbladder (gallstones), heart||
1413|101|P|failure.||
1413|102|P|   You may experience blurred vision, dizziness, or drowsiness||
1413|103|P|due to extremely low or high blood sugar. Do not drive, use||
1413|104|P|machinery, or do anything that needs alertness or clear vision||
1413|105|P|until you can do it safely.||
1413|106|P|   Limit alcohol while taking this medication because it can||
1413|107|P|increase your risk of developing low blood sugar.||
1413|108|P|   It may be harder to control your blood sugar when your body is||
1413|109|P|stressed (such as due to fever, infection, injury, or surgery).||
1413|110|P|Consult your doctor because increased stress may require a change||
1413|111|P|in your treatment plan, medications, or blood sugar testing.||
1413|112|P|   Before having surgery, tell your doctor or dentist about all||
1413|113|P|the products you use (including prescription drugs,||
1413|114|P|nonprescription drugs, and herbal products).||
1413|115|P|   During pregnancy, this medication should be used only when||
1413|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
1413|117|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1413|118|P|your doctor for managing your blood sugar while pregnant. Your||
1413|119|P|doctor may change your diabetes treatment during your pregnancy||
1413|120|P|(such as diet and medications including insulin).||
1413|121|P|   It is unknown if this drug passes into breast milk. Consult||
1413|122|P|your doctor before breastfeeding.||
1413|123|B|||
1413|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1413|125|I|medications work or increase your risk for serious side effects.||
1413|126|I|This document does not contain all possible drug interactions.||
1413|127|I|Keep a list of all the products you use (including||
1413|128|I|prescription/nonprescription drugs and herbal products) and share||
1413|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
1413|130|I|the dosage of any medicines without your doctor's approval.||
1413|131|I|   A product that may interact with this drug is: rifampin.||
1413|132|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1413|133|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1413|134|I|heartbeat you would usually feel when your blood sugar falls too||
1413|135|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1413|136|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1413|137|I|   Many drugs can affect your blood sugar levels, making it more||
1413|138|I|difficult to control your blood sugar. Before you start, stop, or||
1413|139|I|change any medication, talk with your doctor or pharmacist about||
1413|140|I|how the medication may affect your blood sugar. Check your blood||
1413|141|I|sugar regularly as directed by your doctor. Tell your doctor||
1413|142|I|about the results and of any symptoms of high or low blood sugar.||
1413|143|I|(See also Side Effects section.) Your doctor may need to adjust||
1413|144|I|your diabetes medication, exercise program, or diet.||
1413|145|B|||
1413|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1413|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1413|148|O|poison control center right away. US residents can call||
1413|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1413|150|B|||
1413|151|N|NOTES:  Do not share this medication with others.||
1413|152|N|   Lab and/or medical tests (such as blood glucose, hemoglobin||
1413|153|N|A1c) should be done while you are taking this medication. Keep||
1413|154|N|all medical and lab appointments.||
1413|155|N|   Attend a diabetes education program to learn more about how to||
1413|156|N|manage your diabetes with medications, diet, exercise, and||
1413|157|N|regular medical exams.||
1413|158|N|   Learn the symptoms of high and low blood sugar and how to||
1413|159|N|treat low blood sugar. Check your blood sugar regularly as||
1413|160|N|directed and share the results with your doctor.||
1413|161|B|||
1413|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1413|163|D|remember. If it is near the time of the next dose, skip the||
1413|164|D|missed dose. Take your next dose at the regular time. Do not||
1413|165|D|double the dose to catch up.||
1413|166|B|||
1413|167|R|STORAGE:  Store at room temperature away from light and moisture.||
1413|168|R|Do not store in the bathroom. Keep all medications away from||
1413|169|R|children and pets.||
1413|170|R|   Do not flush medications down the toilet or pour them into a||
1413|171|R|drain unless instructed to do so. Properly discard this product||
1413|172|R|when it is expired or no longer needed. Consult your pharmacist||
1413|173|R|or local waste disposal company.||
1413|174|B|||
1413|175|M|MEDICAL ALERT:  Your condition can cause complications in a||
1413|176|M|medical emergency. For information about enrolling in MedicAlert,||
1413|177|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1413|178|B|||
1413|179|A|Information last revised November 2025.||
1413|180|A|Copyright(c) 2025 First Databank, Inc.||
1413|181|B|||
1414|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1414|002|Z|does NOT have all possible information about this product. This||
1414|003|Z|information does not assure that this product is safe, effective,||
1414|004|Z|or appropriate for you. This information is not individual||
1414|005|Z|medical advice and does not substitute for the advice of your||
1414|006|Z|health care professional. Always ask your health care||
1414|007|Z|professional for complete information about this product and your||
1414|008|Z|specific health needs.||
1414|009|B|||
1414|010|T|ABIRATERONE - ORAL||
1414|011|F|(A-bir-A-ter-one)||
1414|012|B|||
1414|013|C|COMMON BRAND NAME(S): Zytiga||
1414|014|B|||
1414|015|U|USES:  This medication is used to treat prostate cancer.||
1414|016|U|Abiraterone belongs to a class of drugs known as anti-androgens||
1414|017|U|(anti-testosterone). Testosterone, a natural hormone, helps||
1414|018|U|prostate cancer to grow and spread. Abiraterone works by blocking||
1414|019|U|the production of testosterone, thereby slowing the growth and||
1414|020|U|spread of prostate cancer.||
1414|021|U|   This medication should not be given to women or children.||
1414|022|B|||
1414|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1414|024|H|from your pharmacist before you start taking abiraterone and each||
1414|025|H|time you get a refill. If you have any questions, ask your doctor||
1414|026|H|or pharmacist.||
1414|027|H|   Different brands of this medication may have different dosing||
1414|028|H|directions. Do not change brands of this medication without your||
1414|029|H|doctor's direction.||
1414|030|H|   Take this medication by mouth on an empty stomach as directed||
1414|031|H|by your doctor, usually once daily. Do not eat food for 2 hours||
1414|032|H|before and 1 hour after taking this medication. Taking this||
1414|033|H|medication with food increases the amount of this drug in your||
1414|034|H|body and increases the risk of side effects. Swallow the tablets||
1414|035|H|whole. Do not crush or chew the tablets.||
1414|036|H|   The dosage is based on your medical condition, lab results,||
1414|037|H|response to treatment, and other medications you may be taking.||
1414|038|H|Be sure to tell your doctor and pharmacist about all the products||
1414|039|H|you use (including prescription drugs, nonprescription drugs, and||
1414|040|H|herbal products).||
1414|041|H|   Use this medication regularly to get the most benefit from it.||
1414|042|H|To help you remember, take it at the same time each day. Do not||
1414|043|H|stop any medications for your prostate cancer unless told to do||
1414|044|H|so by your doctor. Stopping your medications could allow the||
1414|045|H|cancer to spread more rapidly.||
1414|046|H|   Tell your doctor if your condition lasts or gets worse (such||
1414|047|H|as urination becomes more difficult, bone pain increases).||
1414|048|H|   Since this drug can be absorbed through the skin and lungs and||
1414|049|H|may harm an unborn baby, women who are pregnant or who may become||
1414|050|H|pregnant should not handle this medication or breathe the dust||
1414|051|H|from the tablets.||
1414|052|B|||
1414|053|S|SIDE EFFECTS:  Headache, hot flushes, joint pain, heartburn or||
1414|054|S|cold-like symptoms may occur. If any of these effects last or get||
1414|055|S|worse, tell your doctor or pharmacist promptly.||
1414|056|S|   Remember that this medication has been prescribed because your||
1414|057|S|doctor has judged that the benefit to you is greater than the||
1414|058|S|risk of side effects. Many people using this medication do not||
1414|059|S|have serious side effects.||
1414|060|S|   This medication may raise your blood pressure. Check your||
1414|061|S|blood pressure regularly and tell your doctor if the results are||
1414|062|S|high. Your doctor may control your blood pressure with||
1414|063|S|medication.||
1414|064|S|   Tell your doctor right away if you have any serious side||
1414|065|S|effects, including: increased urination, painful urination,||
1414|066|S|muscle cramps/weakness, leg pain, swelling in legs/feet.||
1414|067|S|   Get medical help right away if you have any very serious side||
1414|068|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1414|069|S|dizziness, fainting, symptoms of liver disease (such as||
1414|070|S|nausea/vomiting that doesn't stop, loss of appetite,||
1414|071|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1414|072|S|   A very serious allergic reaction to this drug is rare.||
1414|073|S|However, get medical help right away if you notice any symptoms||
1414|074|S|of a serious allergic reaction, including: rash, itching/swelling||
1414|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1414|076|S|breathing.||
1414|077|S|   This is not a complete list of possible side effects. If you||
1414|078|S|notice other effects not listed above, contact your doctor or||
1414|079|S|pharmacist.||
1414|080|S|   In the US -||
1414|081|S|   Call your doctor for medical advice about side effects. You||
1414|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1414|083|S|www.fda.gov/medwatch.||
1414|084|S|   In Canada - Call your doctor for medical advice about side||
1414|085|S|effects. You may report side effects to Health Canada at||
1414|086|S|1-866-234-2345.||
1414|087|B|||
1414|088|P|PRECAUTIONS:  Before taking abiraterone, tell your doctor or||
1414|089|P|pharmacist if you are allergic to it; or if you have any other||
1414|090|P|allergies. This product may contain inactive ingredients, which||
1414|091|P|can cause allergic reactions or other problems. Talk to your||
1414|092|P|pharmacist for more details.||
1414|093|P|   Before using this medication, tell your doctor or pharmacist||
1414|094|P|your medical history, especially of: previous heart attack, high||
1414|095|P|blood pressure, liver problems, diabetes.||
1414|096|P|   Abiraterone may cause a condition that affects the heart||
1414|097|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1414|098|P|serious (rarely fatal) fast/irregular heartbeat and other||
1414|099|P|symptoms (such as severe dizziness, fainting) that need medical||
1414|100|P|attention right away.||
1414|101|P|   The risk of QT prolongation may be increased if you have||
1414|102|P|certain medical conditions or are taking other drugs that may||
1414|103|P|cause QT prolongation. Before using abiraterone, tell your doctor||
1414|104|P|or pharmacist of all the drugs you take and if you have any of||
1414|105|P|the following conditions: certain heart problems (heart failure,||
1414|106|P|slow heartbeat, QT prolongation in the EKG), family history of||
1414|107|P|certain heart problems (QT prolongation in the EKG, sudden||
1414|108|P|cardiac death).||
1414|109|P|   Low levels of potassium or magnesium in the blood may also||
1414|110|P|increase your risk of QT prolongation. This risk may increase if||
1414|111|P|you use certain drugs (such as diuretics/"water pills") or if you||
1414|112|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1414|113|P|Talk to your doctor about using abiraterone safely.||
1414|114|P|   Using corticosteroid medications for a long time along with||
1414|115|P|abiraterone can make it more difficult for your body to respond||
1414|116|P|to physical stress. Before having surgery or emergency treatment,||
1414|117|P|or if you get a serious illness/injury, tell your doctor or||
1414|118|P|dentist that you are using this medication or have used this||
1414|119|P|medication within the past 12 months. Tell your doctor right away||
1414|120|P|if you develop unusual/extreme tiredness or weight loss. If you||
1414|121|P|will be using this medication for a long time, carry a warning||
1414|122|P|card or medical ID bracelet that identifies your use of this||
1414|123|P|medication.||
1414|124|P|   Before having surgery, tell your doctor or dentist about all||
1414|125|P|the products you use (including prescription drugs,||
1414|126|P|nonprescription drugs, and herbal products).||
1414|127|P|   Older adults may be more sensitive to the side effects of this||
1414|128|P|drug, especially QT prolongation (see above).||
1414|129|P|   This medication should not be used by women, especially during||
1414|130|P|pregnancy or breastfeeding. It may harm an unborn or||
1414|131|P|breastfeeding baby. Men with female partners of childbearing age||
1414|132|P|should use reliable form(s) of birth control while taking this||
1414|133|P|medication and for at least 3 weeks after stopping treatment.||
1414|134|P|Consult your doctor for more details.||
1414|135|B|||
1414|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1414|137|I|medications work or increase your risk for serious side effects.||
1414|138|I|This document does not contain all possible drug interactions.||
1414|139|I|Keep a list of all the products you use (including||
1414|140|I|prescription/nonprescription drugs and herbal products) and share||
1414|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
1414|142|I|the dosage of any medicines without your doctor's approval.||
1414|143|I|   A product that may interact with this drug is: radium Ra 223.||
1414|144|I|   Other medications can affect the removal of abiraterone from||
1414|145|I|your body, which may affect how abiraterone works. Examples||
1414|146|I|include drugs used to treat seizures (such as carbamazepine,||
1414|147|I|phenytoin, phenobarbital, primidone), St. John's wort, among||
1414|148|I|others.||
1414|149|B|||
1414|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1414|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1414|152|O|poison control center right away. US residents can call||
1414|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1414|154|B|||
1414|155|N|NOTES:  Do not share this medication with others.||
1414|156|N|   Lab and/or medical tests (such as blood pressure, potassium||
1414|157|N|levels, liver function, blood PSA test) should be done before you||
1414|158|N|start taking this medication and while you are taking it. Keep||
1414|159|N|all medical and lab appointments. Consult your doctor for more||
1414|160|N|details.||
1414|161|B|||
1414|162|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1414|163|D|next dose at the regular time. Do not double the dose to catch||
1414|164|D|up. If you miss more than one dose, talk to your doctor right||
1414|165|D|away.||
1414|166|B|||
1414|167|R|STORAGE:  Store at room temperature away from light and moisture.||
1414|168|R|Do not store in the bathroom. Keep all medications away from||
1414|169|R|children and pets.||
1414|170|R|   Do not flush medications down the toilet or pour them into a||
1414|171|R|drain unless instructed to do so. Properly discard this product||
1414|172|R|when it is expired or no longer needed. Consult your pharmacist||
1414|173|R|or local waste disposal company.||
1414|174|B|||
1414|175|M|MEDICAL ALERT:  Your condition can cause complications in a||
1414|176|M|medical emergency. For information about enrolling in MedicAlert,||
1414|177|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1414|178|B|||
1414|179|A|Information last revised May 2024.||
1414|180|A|Copyright(c) 2025 First Databank, Inc.||
1414|181|B|||
1415|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1415|002|Z|does NOT have all possible information about this product. This||
1415|003|Z|information does not assure that this product is safe, effective,||
1415|004|Z|or appropriate for you. This information is not individual||
1415|005|Z|medical advice and does not substitute for the advice of your||
1415|006|Z|health care professional. Always ask your health care||
1415|007|Z|professional for complete information about this product and your||
1415|008|Z|specific health needs.||
1415|009|B|||
1415|010|T|VILAZODONE - ORAL||
1415|011|F|(vil-AZ-oh-done)||
1415|012|B|||
1415|013|C|COMMON BRAND NAME(S): Viibryd||
1415|014|B|||
1415|015|W|WARNING:  Antidepressant medications are used to treat a variety||
1415|016|W|of conditions, including depression and other mental/mood||
1415|017|W|disorders. These medications can help prevent suicidal||
1415|018|W|thoughts/attempts and provide other important benefits. However,||
1415|019|W|studies have shown that a small number of people (especially||
1415|020|W|people younger than 25) who take antidepressants for any||
1415|021|W|condition may experience worsening depression, other mental/mood||
1415|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
1415|023|W|talk with the doctor about the risks and benefits of||
1415|024|W|antidepressant medication (especially for people younger than||
1415|025|W|25), even if treatment is not for a mental/mood condition.||
1415|026|W|   Tell the doctor right away if you notice worsening||
1415|027|W|depression/other psychiatric conditions, unusual behavior changes||
1415|028|W|(including possible suicidal thoughts/attempts), or other||
1415|029|W|mental/mood changes (including new/worsening anxiety, panic||
1415|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1415|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
1415|032|W|especially watchful for these symptoms when a new antidepressant||
1415|033|W|is started or when the dose is changed.||
1415|034|B|||
1415|035|U|USES:  This medication is used to treat depression. Vilazodone||
1415|036|U|works by helping to restore the balance of a certain natural||
1415|037|U|substance (serotonin) in the brain.||
1415|038|B|||
1415|039|H|HOW TO USE:  Read the Medication Guide provided by your||
1415|040|H|pharmacist before you start taking vilazodone and each time you||
1415|041|H|get a refill. If you have any questions, ask your doctor or||
1415|042|H|pharmacist.||
1415|043|H|   Take this medication by mouth with food as directed by your||
1415|044|H|doctor, usually once daily. The dosage is based on your medical||
1415|045|H|condition, response to treatment, and other medications you may||
1415|046|H|be taking. Be sure to tell your doctor and pharmacist about all||
1415|047|H|the products you use (including prescription drugs,||
1415|048|H|nonprescription drugs, and herbal products).||
1415|049|H|   To reduce your risk of side effects, your doctor may start you||
1415|050|H|at a low dose and gradually increase your dose. Follow your||
1415|051|H|doctor's instructions carefully. Do not take more or less||
1415|052|H|medication or take it more often than prescribed. Your condition||
1415|053|H|will not improve any faster and your risk of side effects will||
1415|054|H|increase.||
1415|055|H|   Use this medication regularly to get the most benefit from it.||
1415|056|H|To help you remember, take it at the same time each day.||
1415|057|H|   If you suddenly stop using this medication, you may have||
1415|058|H|withdrawal symptoms (such as mood swings, headache, tiredness,||
1415|059|H|sleep changes, ringing in the ears, seizures, numbness/tingling,||
1415|060|H|"shock-like" feelings). To help prevent withdrawal, your doctor||
1415|061|H|may lower your dose slowly. Withdrawal is more likely if you have||
1415|062|H|used vilazodone for a long time or in high doses. Tell your||
1415|063|H|doctor or pharmacist right away if you have withdrawal.||
1415|064|H|   Tell your doctor if your condition lasts or gets worse.||
1415|065|B|||
1415|066|S|SIDE EFFECTS:  See also Warning section.||
1415|067|S|   Diarrhea, nausea, vomiting, dizziness, or trouble sleeping may||
1415|068|S|occur. If any of these effects last or get worsen, tell your||
1415|069|S|doctor or pharmacist promptly.||
1415|070|S|   Remember that this medication has been prescribed because your||
1415|071|S|doctor has judged that the benefit to you is greater than the||
1415|072|S|risk of side effects. Many people using this medication do not||
1415|073|S|have serious side effects.||
1415|074|S|   Tell your doctor right away if you have any serious side||
1415|075|S|effects, including: easy bleeding/bruising, numbness/tingling,||
1415|076|S|tremor, inability to keep still, difficulty concentrating,||
1415|077|S|confusion, memory problems, weakness, unsteadiness, decreased||
1415|078|S|interest in sex, changes in sexual ability.||
1415|079|S|   Get medical help right away if you have any very serious side||
1415|080|S|effects, including: black stools, vomit that looks like coffee||
1415|081|S|grounds, seizures, eye pain/swelling/redness, widened pupils,||
1415|082|S|vision changes (such as seeing rainbows around lights at night,||
1415|083|S|blurred vision).||
1415|084|S|   This medication may increase serotonin and rarely cause a very||
1415|085|S|serious condition called serotonin syndrome/toxicity. The risk||
1415|086|S|increases if you are also taking other drugs that increase||
1415|087|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1415|088|S|take (see Drug Interactions section). Get medical help right away||
1415|089|S|if you develop some of the following symptoms: fast heartbeat,||
1415|090|S|hallucinations, loss of coordination, severe dizziness, severe||
1415|091|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1415|092|S|unusual agitation/restlessness.||
1415|093|S|   A very serious allergic reaction to this drug is rare.||
1415|094|S|However, get medical help right away if you notice any symptoms||
1415|095|S|of a serious allergic reaction, including: rash, itching/swelling||
1415|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1415|097|S|breathing.||
1415|098|S|   This is not a complete list of possible side effects. If you||
1415|099|S|notice other effects not listed above, contact your doctor or||
1415|100|S|pharmacist.||
1415|101|S|   In the US -||
1415|102|S|   Call your doctor for medical advice about side effects. You||
1415|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1415|104|S|www.fda.gov/medwatch.||
1415|105|S|   In Canada - Call your doctor for medical advice about side||
1415|106|S|effects. You may report side effects to Health Canada at||
1415|107|S|1-866-234-2345.||
1415|108|B|||
1415|109|P|PRECAUTIONS:  Before taking vilazodone, tell your doctor or||
1415|110|P|pharmacist if you are allergic to it; or if you have any other||
1415|111|P|allergies. This product may contain inactive ingredients, which||
1415|112|P|can cause allergic reactions or other problems. Talk to your||
1415|113|P|pharmacist for more details.||
1415|114|P|   Before using this medication, tell your doctor or pharmacist||
1415|115|P|your medical history, especially of: personal or family history||
1415|116|P|of bipolar/manic-depressive disorder, personal or family history||
1415|117|P|of suicide attempts, intestinal ulcers/bleeding (peptic ulcer||
1415|118|P|disease), seizures, personal or family history of glaucoma||
1415|119|P|(angle-closure type).||
1415|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1415|121|P|can make you more dizzy. Do not drive, use machinery, or do||
1415|122|P|anything that needs alertness until you can do it safely. Avoid||
1415|123|P|alcoholic beverages. Talk to your doctor if you are using||
1415|124|P|marijuana (cannabis).||
1415|125|P|   Before having surgery, tell your doctor or dentist about all||
1415|126|P|the products you use (including prescription drugs,||
1415|127|P|nonprescription drugs, and herbal products).||
1415|128|P|   Older adults may be more sensitive to the side effects of this||
1415|129|P|drug, especially bleeding. They are also more likely to develop a||
1415|130|P|salt imbalance (hyponatremia), especially if they are also taking||
1415|131|P|"water pills" (diuretics) with this medication. Salt imbalance||
1415|132|P|can increase the risk of falling.||
1415|133|P|   During pregnancy, this medication should be used only when||
1415|134|P|clearly needed. It may harm an unborn baby. Also, babies born to||
1415|135|P|mothers who have used this drug during the last 3 months of||
1415|136|P|pregnancy may rarely develop withdrawal symptoms such as||
1415|137|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
1415|138|P|constant crying. If you notice any of these symptoms in your||
1415|139|P|newborn, tell the doctor promptly.||
1415|140|P|   Since untreated mental/mood problems (such as depression) can||
1415|141|P|be a serious condition, do not stop taking this medication unless||
1415|142|P|directed by your doctor. If you are planning pregnancy, become||
1415|143|P|pregnant, or think you may be pregnant, immediately discuss with||
1415|144|P|your doctor the benefits and risks of using this medication||
1415|145|P|during pregnancy.||
1415|146|P|   It is unknown if this drug passes into breast milk. Consult||
1415|147|P|your doctor before breastfeeding.||
1415|148|B|||
1415|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1415|150|I|medications work or increase your risk for serious side effects.||
1415|151|I|This document does not contain all possible drug interactions.||
1415|152|I|Keep a list of all the products you use (including||
1415|153|I|prescription/nonprescription drugs and herbal products) and share||
1415|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
1415|155|I|the dosage of any medicines without your doctor's approval.||
1415|156|I|   Some products that may interact with this drug are: other||
1415|157|I|drugs that can cause bleeding/bruising (including antiplatelet||
1415|158|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
1415|159|I|"blood thinners" such as dabigatran/warfarin).||
1415|160|I|   Aspirin can increase the risk of bleeding when used with this||
1415|161|I|medication. However, if your doctor has told you to take low-dose||
1415|162|I|aspirin to prevent heart attack or stroke (usually 81-162||
1415|163|I|milligrams a day), you should keep taking the aspirin unless your||
1415|164|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1415|165|I|details.||
1415|166|I|   Taking MAO inhibitors with this medication may cause a serious||
1415|167|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1415|168|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1415|169|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1415|170|I|selegiline, tranylcypromine) during treatment with this||
1415|171|I|medication. Most MAO inhibitors should also not be taken for two||
1415|172|I|weeks before and after treatment with this medication. Ask your||
1415|173|I|doctor when to start or stop taking this medication.||
1415|174|I|   The risk of serotonin syndrome/toxicity increases if you are||
1415|175|I|also taking other drugs that increase serotonin. Examples include||
1415|176|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1415|177|I|antidepressants (including other SSRIs such as||
1415|178|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
1415|179|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
1415|180|I|may be more likely when you start or increase the dose of these||
1415|181|I|drugs.||
1415|182|I|   This medication may interfere with certain medical/lab tests||
1415|183|I|(such as brain scan for Parkinson's disease), possibly causing||
1415|184|I|false test results. Make sure lab personnel and all your doctors||
1415|185|I|know you use this drug.||
1415|186|B|||
1415|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1415|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1415|189|O|poison control center right away. US residents can call||
1415|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1415|191|B|||
1415|192|N|NOTES:  Do not share this medication with others.||
1415|193|N|   Keep all medical and lab appointments.||
1415|194|B|||
1415|195|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1415|196|D|remember. If it is near the time of the next dose, skip the||
1415|197|D|missed dose. Take your next dose at the regular time. Do not||
1415|198|D|double the dose to catch up.||
1415|199|B|||
1415|200|R|STORAGE:  Store at room temperature away from light and moisture.||
1415|201|R|Do not store in the bathroom. Keep all medications away from||
1415|202|R|children and pets.||
1415|203|R|   Do not flush medications down the toilet or pour them into a||
1415|204|R|drain unless instructed to do so. Properly discard this product||
1415|205|R|when it is expired or no longer needed. Consult your pharmacist||
1415|206|R|or local waste disposal company.||
1415|207|B|||
1415|208|A|Information last revised July 2025.||
1415|209|A|Copyright(c) 2025 First Databank, Inc.||
1415|210|B|||
1417|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1417|002|Z|does NOT have all possible information about this product. This||
1417|003|Z|information does not assure that this product is safe, effective,||
1417|004|Z|or appropriate for you. This information is not individual||
1417|005|Z|medical advice and does not substitute for the advice of your||
1417|006|Z|health care professional. Always ask your health care||
1417|007|Z|professional for complete information about this product and your||
1417|008|Z|specific health needs.||
1417|009|B|||
1417|010|T|FERRIC MALTOL - ORAL||
1417|011|F|(FER-ik MAWL-tol)||
1417|012|B|||
1417|013|C|COMMON BRAND NAME(S): Accrufer||
1417|014|B|||
1417|015|W|WARNING:  Accidental overdose of iron-containing products is a||
1417|016|W|leading cause of fatal poisoning in children younger than 6||
1417|017|W|years. Keep this product out of reach of children. If overdose||
1417|018|W|does occur, get medical help right away or call a poison control||
1417|019|W|center. See also Overdose section.||
1417|020|B|||
1417|021|U|USES:  Ferric maltol is an iron supplement used to treat low||
1417|022|U|levels of iron in the blood (such as those caused by anemia).||
1417|023|U|Iron is an important mineral that the body needs to produce red||
1417|024|U|blood cells and keep you in good health.||
1417|025|B|||
1417|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1417|027|H|from your pharmacist before you start taking ferric maltol and||
1417|028|H|each time you get a refill. If you have any questions, ask your||
1417|029|H|doctor or pharmacist.||
1417|030|H|   Take this medication by mouth on an empty stomach (at least 1||
1417|031|H|hour before or 2 hours after meals) as directed by your doctor,||
1417|032|H|usually twice daily. Swallow the capsules whole. Do not open,||
1417|033|H|break, or chew the capsules. Take this medication with a full||
1417|034|H|glass of water (8 ounces/240 milliliters) unless your doctor||
1417|035|H|directs you otherwise. Do not lie down for at least 10 minutes||
1417|036|H|after taking this medication.||
1417|037|H|   Use this medication regularly to get the most benefit from it.||
1417|038|H|To help you remember, take it at the same times each day.||
1417|039|B|||
1417|040|S|SIDE EFFECTS:  Constipation, diarrhea, gas, nausea, and||
1417|041|S|stomach/abdominal pain may occur. If any of these effects last or||
1417|042|S|get worse, tell your doctor or pharmacist promptly.||
1417|043|S|   Iron may cause your stools to turn black, an effect that is||
1417|044|S|not harmful.||
1417|045|S|   Remember that this medication has been prescribed because your||
1417|046|S|doctor has judged that the benefit to you is greater than the||
1417|047|S|risk of side effects. Many people using this medication do not||
1417|048|S|have serious side effects.||
1417|049|S|   A very serious allergic reaction to this product is rare.||
1417|050|S|However, get medical help right away if you notice any symptoms||
1417|051|S|of a serious allergic reaction, including: rash, itching/swelling||
1417|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1417|053|S|breathing.||
1417|054|S|   This is not a complete list of possible side effects. If you||
1417|055|S|notice other effects not listed above, contact your doctor or||
1417|056|S|pharmacist.||
1417|057|S|   In the US -||
1417|058|S|   Call your doctor for medical advice about side effects. You||
1417|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1417|060|S|www.fda.gov/medwatch.||
1417|061|S|   In Canada - Call your doctor for medical advice about side||
1417|062|S|effects. You may report side effects to Health Canada at||
1417|063|S|1-866-234-2345.||
1417|064|B|||
1417|065|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1417|066|P|pharmacist if you are allergic to it; or if you have any other||
1417|067|P|allergies. This product may contain inactive ingredients, which||
1417|068|P|can cause allergic reactions or other problems. Talk to your||
1417|069|P|pharmacist for more details.||
1417|070|P|   Before using this medication, tell your doctor or pharmacist||
1417|071|P|your medical history, especially of: iron overload disorders||
1417|072|P|(such as hemochromatosis), repeated blood transfusions,||
1417|073|P|stomach/intestinal problems (such as ulcer, colitis).||
1417|074|P|   Before having surgery, tell your doctor or dentist about all||
1417|075|P|the products you use (including prescription drugs,||
1417|076|P|nonprescription drugs, and herbal products).||
1417|077|P|   Tell your doctor if you are pregnant before using this||
1417|078|P|product.||
1417|079|P|   Iron passes into breast milk. Consult your doctor before||
1417|080|P|breastfeeding.||
1417|081|B|||
1417|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1417|083|I|medications work or increase your risk for serious side effects.||
1417|084|I|This document does not contain all possible drug interactions.||
1417|085|I|Keep a list of all the products you use (including||
1417|086|I|prescription/nonprescription drugs and herbal products) and share||
1417|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
1417|088|I|the dosage of any medicines without your doctor's approval.||
1417|089|I|   This product can decrease the absorption of other drugs,||
1417|090|I|including bisphosphonates (such as alendronate), levodopa,||
1417|091|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
1417|092|I|levofloxacin), thyroid medications (such as levothyroxine),||
1417|093|I|tetracycline antibiotics (such as doxycycline, minocycline),||
1417|094|I|among others. Separate your doses of these medications as far as||
1417|095|I|possible from your doses of this product. Ask your doctor or||
1417|096|I|pharmacist about how long you should wait between doses and for||
1417|097|I|help finding a dosing schedule that will work with all your||
1417|098|I|medications.||
1417|099|I|   This product may interfere with certain lab tests (including||
1417|100|I|testing for blood in stool), possibly causing false test results.||
1417|101|I|Make sure lab personnel and all your doctors know you use this||
1417|102|I|drug.||
1417|103|B|||
1417|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1417|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1417|106|O|poison control center right away. US residents can call||
1417|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1417|108|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
1417|109|O|diarrhea, weakness.||
1417|110|B|||
1417|111|N|NOTES:  Do not share this product with others.||
1417|112|N|   This product is not a substitute for a proper diet. It is||
1417|113|N|important to maintain a well-balanced diet. Foods rich in iron||
1417|114|N|include red meats (especially liver), fish, beans, dried fruit,||
1417|115|N|and iron-fortified/enriched cereals and bread.||
1417|116|N|   Lab and/or medical tests (such as iron/ferritin levels,||
1417|117|N|complete blood count) should be done while you are taking this||
1417|118|N|medication. Keep all medical and lab appointments. Consult your||
1417|119|N|doctor for more details.||
1417|120|B|||
1417|121|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1417|122|D|remember. If it is near the time of the next dose, skip the||
1417|123|D|missed dose. Take your next dose at the regular time. Do not||
1417|124|D|double the dose to catch up.||
1417|125|B|||
1417|126|R|STORAGE:  Store at room temperature away from light and moisture.||
1417|127|R|Do not store in the bathroom. Keep all medications away from||
1417|128|R|children and pets.||
1417|129|R|   Do not flush medications down the toilet or pour them into a||
1417|130|R|drain unless instructed to do so. Properly discard this product||
1417|131|R|when it is expired or no longer needed. Consult your pharmacist||
1417|132|R|or local waste disposal company.||
1417|133|B|||
1417|134|A|Information last revised May 2024.||
1417|135|A|Copyright(c) 2025 First Databank, Inc.||
1417|136|B|||
1418|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1418|002|Z|does NOT have all possible information about this product. This||
1418|003|Z|information does not assure that this product is safe, effective,||
1418|004|Z|or appropriate for you. This information is not individual||
1418|005|Z|medical advice and does not substitute for the advice of your||
1418|006|Z|health care professional. Always ask your health care||
1418|007|Z|professional for complete information about this product and your||
1418|008|Z|specific health needs.||
1418|009|B|||
1418|010|T|KETOROLAC SPRAY - NASAL||
1418|011|F|(KEE-toe-ROLE-ak)||
1418|012|B|||
1418|013|C|COMMON BRAND NAME(S): Sprix||
1418|014|B|||
1418|015|W|WARNING:  Do not use any ketorolac products (including this nasal||
1418|016|W|spray, tablets, or injection) for more than a total of 5 days. Do||
1418|017|W|not use this medication for minor or long-term painful||
1418|018|W|conditions.||
1418|019|W|   This drug may rarely cause serious (rarely fatal) bleeding||
1418|020|W|from the stomach or intestines. This effect can occur without||
1418|021|W|warning at any time while using this drug. Older adults may be at||
1418|022|W|higher risk for this effect. Do not use this medication if you||
1418|023|W|have stomach/intestinal problems (such as ulcers, bleeding).||
1418|024|W|   This drug may also increase your risk of serious bleeding in||
1418|025|W|other parts of your body. Do not use this medication if you have||
1418|026|W|bleeding or blood clotting problems, or are at high risk for||
1418|027|W|bleeding.||
1418|028|W|   Nonsteroidal anti-inflammatory drugs (including ketorolac) may||
1418|029|W|rarely increase the risk for a heart attack or stroke. This||
1418|030|W|effect can happen at any time while using this drug but is more||
1418|031|W|likely if you use it for a long time. The risk may be greater in||
1418|032|W|older adults or if you have heart disease or increased risk for||
1418|033|W|heart disease (for example, due to smoking, family history of||
1418|034|W|heart disease, or conditions such as high blood pressure or||
1418|035|W|diabetes). Talk to your doctor about the benefits and risks of||
1418|036|W|using this drug.||
1418|037|W|   Do not use this drug right before or after heart bypass||
1418|038|W|surgery (CABG) or before any surgery. It also should not be used||
1418|039|W|during labor/delivery or in people with severe kidney problems or||
1418|040|W|high risk for kidney problems.||
1418|041|W|   Stop using ketorolac and get medical help right away if you||
1418|042|W|notice any of the following rare but serious side effects: bloody||
1418|043|W|or black/tarry stools, stomach/abdominal pain, vomit that looks||
1418|044|W|like coffee grounds, unusual or easy bruising/bleeding,||
1418|045|W|chest/jaw/left arm pain, shortness of breath, unusual sweating,||
1418|046|W|weakness on one side of the body, sudden vision changes, trouble||
1418|047|W|speaking.||
1418|048|B|||
1418|049|U|USES:  Ketorolac is used for the short-term treatment (up to 5||
1418|050|U|days) of moderate to severe pain in adults, such as after||
1418|051|U|surgery. Reducing pain helps you recover more comfortably so you||
1418|052|U|can return to your normal daily activities. This medication is a||
1418|053|U|nonsteroidal anti-inflammatory drug (NSAID). It works by||
1418|054|U|decreasing inflammation, swelling, and pain.||
1418|055|B|||
1418|056|H|HOW TO USE:  Read the Medication Guide provided by your||
1418|057|H|pharmacist before you start using ketorolac and each time you get||
1418|058|H|a refill. Also read and follow the product instructions for how||
1418|059|H|to properly prime and use this nasal spray. If you have any||
1418|060|H|questions, ask your doctor or pharmacist.||
1418|061|H|   Spray this medication in your nose as directed by your doctor,||
1418|062|H|usually every 6 to 8 hours. Your doctor may adjust your dosage so||
1418|063|H|that you spray the medication in only one nostril instead of both||
1418|064|H|nostrils. The dosage is based on your medical condition, age,||
1418|065|H|weight, and response to treatment.||
1418|066|H|   To reduce your risk of stomach bleeding and other side||
1418|067|H|effects, use this medication at the lowest effective dose for the||
1418|068|H|shortest possible time. Do not increase your dose or use this||
1418|069|H|drug more often or for longer than prescribed. Your condition||
1418|070|H|will not improve any faster, and your risk of side effects will||
1418|071|H|increase.||
1418|072|H|   Use this medication regularly to get the most benefit from it.||
1418|073|H|To help you remember, use it at the same times each day.||
1418|074|H|   If you are using this drug "as needed" (not on a regular||
1418|075|H|schedule), remember that pain medications work best if they are||
1418|076|H|used as the first signs of pain occur. If you wait until the pain||
1418|077|H|has worsened, the medicine may not work as well.||
1418|078|H|   Drink plenty of fluids during treatment with this medication.||
1418|079|H|This will help reduce the risk of kidney problems.||
1418|080|H|   Avoid getting this medication in your eyes. If this occurs,||
1418|081|H|rinse your eyes with water or saline and call your doctor if eye||
1418|082|H|irritation lasts.||
1418|083|H|   Tell your doctor if your condition does not get better or if||
1418|084|H|it gets worse.||
1418|085|B|||
1418|086|S|SIDE EFFECTS:  See also Warning section.||
1418|087|S|   Mild and temporary irritation/discomfort in the nose may||
1418|088|S|occur. Upset stomach, nausea, dizziness, or drowsiness may also||
1418|089|S|occur. If any of these effects last or get worse, tell your||
1418|090|S|doctor or pharmacist promptly.||
1418|091|S|   Remember that this medication has been prescribed because your||
1418|092|S|doctor has judged that the benefit to you is greater than the||
1418|093|S|risk of side effects. Many people using this medication do not||
1418|094|S|have serious side effects.||
1418|095|S|   This medication may raise your blood pressure. Check your||
1418|096|S|blood pressure regularly and tell your doctor if the results are||
1418|097|S|high.||
1418|098|S|   Tell your doctor right away if you have any serious side||
1418|099|S|effects, including: signs of kidney problems (such as change in||
1418|100|S|the amount of urine), hearing changes (such as ringing in the||
1418|101|S|ears), mental/mood changes, symptoms of heart failure (such as||
1418|102|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
1418|103|S|gain).||
1418|104|S|   This drug may rarely cause serious (possibly fatal) liver||
1418|105|S|disease. Stop using ketorolac and get medical help right away if||
1418|106|S|you have any symptoms of liver damage, including: nausea/vomiting||
1418|107|S|that doesn't stop, loss of appetite, stomach/abdominal pain,||
1418|108|S|yellowing eyes/skin, dark urine.||
1418|109|S|   A very serious allergic reaction to this drug is rare.||
1418|110|S|However, get medical help right away if you notice any symptoms||
1418|111|S|of a serious allergic reaction, including: fever, swollen lymph||
1418|112|S|nodes, rash, itching/swelling (especially of the||
1418|113|S|face/tongue/throat), severe dizziness, trouble breathing.||
1418|114|S|   This is not a complete list of possible side effects. If you||
1418|115|S|notice other effects not listed above, contact your doctor or||
1418|116|S|pharmacist.||
1418|117|S|   In the US -||
1418|118|S|   Call your doctor for medical advice about side effects. You||
1418|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1418|120|S|www.fda.gov/medwatch.||
1418|121|S|   In Canada - Call your doctor for medical advice about side||
1418|122|S|effects. You may report side effects to Health Canada at||
1418|123|S|1-866-234-2345.||
1418|124|B|||
1418|125|P|PRECAUTIONS:  See also Warning section.||
1418|126|P|   Before using ketorolac, tell your doctor or pharmacist if you||
1418|127|P|are allergic to it; or to aspirin; or to other NSAIDs (such as||
1418|128|P|ibuprofen, naproxen, celecoxib); or if you have any other||
1418|129|P|allergies. This product may contain inactive ingredients (such as||
1418|130|P|EDTA), which can cause allergic reactions or other problems. Talk||
1418|131|P|to your pharmacist for more details.||
1418|132|P|   Before using this medication, tell your doctor or pharmacist||
1418|133|P|your medical history, especially of: asthma (including a history||
1418|134|P|of worsening breathing after taking aspirin or other NSAIDs),||
1418|135|P|growths in the nose (nasal polyps), heart disease (such as||
1418|136|P|previous heart attack), high blood pressure, liver disease,||
1418|137|P|swelling of the hands/ankles/feet (edema).||
1418|138|P|   Kidney problems can sometimes occur with the use of NSAID||
1418|139|P|medications, including ketorolac. Problems are more likely to||
1418|140|P|occur if you are dehydrated, have heart failure or kidney||
1418|141|P|disease, are an older adult, or if you take certain medications||
1418|142|P|(see also Drug Interactions section). Drink plenty of fluids as||
1418|143|P|directed by your doctor to prevent dehydration and tell your||
1418|144|P|doctor right away if you have a change in the amount of urine.||
1418|145|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1418|146|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1418|147|P|machinery, or do anything that needs alertness until you can do||
1418|148|P|it safely. Talk to your doctor if you are using marijuana||
1418|149|P|(cannabis).||
1418|150|P|   Daily use of alcohol and tobacco, especially when combined||
1418|151|P|with this medication, may increase your risk for stomach||
1418|152|P|bleeding. Limit alcohol and stop smoking.||
1418|153|P|   This medication may make you more sensitive to the sun. Limit||
1418|154|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1418|155|P|sunscreen and wear protective clothing when outdoors. Tell your||
1418|156|P|doctor right away if you get sunburned or have skin||
1418|157|P|blisters/redness.||
1418|158|P|   Before having surgery, tell your doctor or dentist about all||
1418|159|P|the products you use (including prescription drugs,||
1418|160|P|nonprescription drugs, and herbal products).||
1418|161|P|   Older adults may be at greater risk for stomach/intestinal||
1418|162|P|bleeding, kidney problems, heart attack, and stroke while using||
1418|163|P|this drug.||
1418|164|P|   Before using this medication, women of childbearing age should||
1418|165|P|talk with their doctor(s) about the benefits and risks. Tell your||
1418|166|P|doctor if you are pregnant or if you plan to become pregnant.||
1418|167|P|This medication may harm an unborn baby and cause problems with||
1418|168|P|normal labor/delivery. It is not recommended for use in pregnancy||
1418|169|P|from 20 weeks until delivery. If your doctor decides that you||
1418|170|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1418|171|P|you should use the lowest effective dose for the shortest||
1418|172|P|possible time. You should not use this medication after 30 weeks||
1418|173|P|of pregnancy.||
1418|174|P|   This drug passes into breast milk. Consult your doctor before||
1418|175|P|breastfeeding.||
1418|176|B|||
1418|177|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1418|178|I|medications work or increase your risk for serious side effects.||
1418|179|I|This document does not contain all possible drug interactions.||
1418|180|I|Keep a list of all the products you use (including||
1418|181|I|prescription/nonprescription drugs and herbal products) and share||
1418|182|I|it with your doctor and pharmacist. Do not start, stop, or change||
1418|183|I|the dosage of any medicines without your doctor's approval.||
1418|184|I|   Some products that may interact with this drug include:||
1418|185|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1418|186|I|angiotensin II receptor blockers (such as valsartan, losartan),||
1418|187|I|cidofovir, corticosteroids (such as prednisone), "water pills"||
1418|188|I|(diuretics such as furosemide).||
1418|189|I|   Other medications can affect the removal of ketorolac from||
1418|190|I|your body, which may affect how ketorolac works. Examples include||
1418|191|I|cabotegravir, leflunomide, nitisinone, probenecid, teriflunomide,||
1418|192|I|vadadustat, among others.||
1418|193|I|   This medication may increase the risk of bleeding when used||
1418|194|I|with other drugs that also may cause bleeding. Examples include||
1418|195|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1418|196|I|dabigatran/enoxaparin/warfarin, pentoxifylline, among others.||
1418|197|I|   Do not use this medication with other forms of ketorolac, high||
1418|198|I|doses of aspirin, or other NSAIDs.||
1418|199|I|   Check all prescription and nonprescription medicine labels||
1418|200|I|carefully since many medications contain pain relievers/fever||
1418|201|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These||
1418|202|I|drugs are similar to ketorolac and may increase your risk of side||
1418|203|I|effects if taken together. However, if your doctor has told you||
1418|204|I|to take low-dose aspirin to prevent heart attack or stroke||
1418|205|I|(usually 81-162 milligrams a day), you should keep taking the||
1418|206|I|aspirin unless your doctor tells you not to. Ask your doctor or||
1418|207|I|pharmacist for more details.||
1418|208|B|||
1418|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1418|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1418|211|O|poison control center right away. US residents can call||
1418|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1418|213|O|Symptoms of overdose may include: nausea, vomiting, stomach pain,||
1418|214|O|drowsiness.||
1418|215|B|||
1418|216|N|NOTES:  Do not share this medication with others.||
1418|217|N|   Lab and/or medical tests (including blood pressure, kidney||
1418|218|N|function) may be done while you are using this medication. Keep||
1418|219|N|all medical and lab appointments. Consult your doctor for more||
1418|220|N|details.||
1418|221|B|||
1418|222|D|MISSED DOSE:  If you are using this medication on a regular||
1418|223|D|schedule (not just "as needed") and you miss a dose, use it as||
1418|224|D|soon as you remember. If it is near the time of the next dose,||
1418|225|D|skip the missed dose. Use your next dose at the regular time. Do||
1418|226|D|not double the dose to catch up.||
1418|227|B|||
1418|228|R|STORAGE:  Store unopened bottles in the refrigerator. Do not||
1418|229|R|freeze. Store the opened bottle at room temperature, away from||
1418|230|R|light and direct sunlight. Since this medication does not contain||
1418|231|R|preservatives, it expires 24 hours after first using. Keep all||
1418|232|R|medications away from children and pets.||
1418|233|R|   Do not flush medications down the toilet or pour them into a||
1418|234|R|drain unless instructed to do so. Properly discard this product||
1418|235|R|when it is expired or no longer needed. Consult your pharmacist||
1418|236|R|or local waste disposal company.||
1418|237|B|||
1418|238|A|Information last revised July 2025.||
1418|239|A|Copyright(c) 2025 First Databank, Inc.||
1418|240|B|||
1419|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1419|002|Z|does NOT have all possible information about this product. This||
1419|003|Z|information does not assure that this product is safe, effective,||
1419|004|Z|or appropriate for you. This information is not individual||
1419|005|Z|medical advice and does not substitute for the advice of your||
1419|006|Z|health care professional. Always ask your health care||
1419|007|Z|professional for complete information about this product and your||
1419|008|Z|specific health needs.||
1419|009|B|||
1419|010|T|LEUPROLIDE 6 MONTH (45 MG) - INTRAMUSCULAR INJECTION||
1419|011|F|(LOO-proe-lide)||
1419|012|B|||
1419|013|C|COMMON BRAND NAME(S): Lupron Depot||
1419|014|B|||
1419|015|U|USES:  Leuprolide is used to treat advanced prostate cancer. It||
1419|016|U|is not a cure. Most types of prostate cancer need the hormone||
1419|017|U|testosterone to grow and spread. Leuprolide works by reducing the||
1419|018|U|amount of testosterone that the body makes. This helps slow or||
1419|019|U|stop the growth of cancer cells and helps relieve symptoms such||
1419|020|U|as painful/difficult urination. Talk to your doctor about the||
1419|021|U|risks and benefits of treatment.||
1419|022|B|||
1419|023|H|HOW TO USE:  This medication is given by injection into a muscle||
1419|024|H|by a health care professional. It is given as directed by your||
1419|025|H|doctor, usually once every 6 months (every 24 weeks). This||
1419|026|H|product slowly releases the medication into your blood over a||
1419|027|H|6-month period.||
1419|028|H|   Use this medication regularly to get the most benefit from it.||
1419|029|H|To help you remember, mark your calendar with a reminder.||
1419|030|H|   During the first few weeks of treatment, your hormone levels||
1419|031|H|will actually go up before they go down. This is a normal||
1419|032|H|response to this medication. Your symptoms may get worse for a||
1419|033|H|few weeks. If you have prostate cancer that has spread to the||
1419|034|H|spine or caused urinary blockage, you may require closer||
1419|035|H|monitoring by your doctor, especially when you first start||
1419|036|H|treatment. Tell your doctor right away if you have any bone pain,||
1419|037|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
1419|038|H|painful/difficult urination, unusual weakness, or inability to||
1419|039|H|move.||
1419|040|B|||
1419|041|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
1419|042|S|sweats, tiredness, swelling of the ankles/feet, increased||
1419|043|S|urination at night, dizziness, or mild burning/pain/bruising at||
1419|044|S|the injection site may occur. If any of these effects last or get||
1419|045|S|worse, tell your doctor or pharmacist promptly.||
1419|046|S|   Rarely, shrinking of the testicles, breast||
1419|047|S|tenderness/swelling, or reduced sexual interest/ability may also||
1419|048|S|occur as a result of lowered testosterone levels. Talk to your||
1419|049|S|doctor if these effects occur.||
1419|050|S|   Remember that this medication has been prescribed because your||
1419|051|S|doctor has judged that the benefit to you is greater than the||
1419|052|S|risk of side effects. Many people using this medication do not||
1419|053|S|have serious side effects.||
1419|054|S|   Tell your doctor right away if you have any serious side||
1419|055|S|effects, including: new/worsening bone pain, easily broken bones,||
1419|056|S|increased thirst/urination, mental/mood changes (such as||
1419|057|S|depression, thoughts of suicide, mood swings, aggression), signs||
1419|058|S|of liver disease (such as nausea/vomiting that doesn't stop, loss||
1419|059|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1419|060|S|urine).||
1419|061|S|   Get medical help right away if you have any very serious side||
1419|062|S|effects, including: symptoms of a heart attack (such as||
1419|063|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
1419|064|S|signs of a stroke (such as weakness on one side of the body,||
1419|065|S|trouble speaking, sudden vision changes, confusion), seizures,||
1419|066|S|fast/irregular heartbeat, severe dizziness, fainting.||
1419|067|S|   A very serious allergic reaction to this drug is rare.||
1419|068|S|However, get medical help right away if you notice any symptoms||
1419|069|S|of a serious allergic reaction, including: fever, swollen lymph||
1419|070|S|nodes, rash, itching/swelling (especially of the||
1419|071|S|face/tongue/throat), severe dizziness, trouble breathing.||
1419|072|S|   This is not a complete list of possible side effects. If you||
1419|073|S|notice other effects not listed above, contact your doctor or||
1419|074|S|pharmacist.||
1419|075|S|   In the US -||
1419|076|S|   Call your doctor for medical advice about side effects. You||
1419|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1419|078|S|www.fda.gov/medwatch.||
1419|079|S|   In Canada - Call your doctor for medical advice about side||
1419|080|S|effects. You may report side effects to Health Canada at||
1419|081|S|1-866-234-2345.||
1419|082|B|||
1419|083|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
1419|084|P|pharmacist if you are allergic to it; or to similar drugs (such||
1419|085|P|as histrelin, triptorelin); or if you have any other allergies.||
1419|086|P|This product may contain inactive ingredients, which can cause||
1419|087|P|allergic reactions or other problems. Talk to your pharmacist for||
1419|088|P|more details.||
1419|089|P|   Before using this medication, tell your doctor or pharmacist||
1419|090|P|your medical history, especially of: diabetes, heart disease||
1419|091|P|(such as heart attack), stroke, high cholesterol, mental/mood||
1419|092|P|problems (such as depression), seizures.||
1419|093|P|   Leuprolide may weaken your bones and increase your risk for||
1419|094|P|bone loss (osteoporosis) if used for a long time. Before using||
1419|095|P|this medication, tell your doctor or pharmacist if you have||
1419|096|P|osteoporosis or if you have any of the following risk factors for||
1419|097|P|osteoporosis: long-term alcohol use, smoking, family history of||
1419|098|P|osteoporosis and broken bones, use of certain medications (for||
1419|099|P|example, corticosteroids such as prednisone, certain anti-seizure||
1419|100|P|drugs such as phenytoin).||
1419|101|P|   Leuprolide may cause a condition that affects the heart rhythm||
1419|102|P|(QT prolongation). QT prolongation can rarely cause serious||
1419|103|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1419|104|P|as severe dizziness, fainting) that need medical attention right||
1419|105|P|away.||
1419|106|P|   The risk of QT prolongation may be increased if you have||
1419|107|P|certain medical conditions or are taking other drugs that may||
1419|108|P|cause QT prolongation. Before using leuprolide, tell your doctor||
1419|109|P|or pharmacist of all the drugs you take and if you have any of||
1419|110|P|the following conditions: certain heart problems (heart failure,||
1419|111|P|slow heartbeat, QT prolongation in the EKG), family history of||
1419|112|P|certain heart problems (QT prolongation in the EKG, sudden||
1419|113|P|cardiac death).||
1419|114|P|   Low levels of potassium or magnesium in the blood may also||
1419|115|P|increase your risk of QT prolongation. This risk may increase if||
1419|116|P|you use certain drugs (such as diuretics/"water pills") or if you||
1419|117|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1419|118|P|Talk to your doctor about using leuprolide safely.||
1419|119|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1419|120|P|can make you more dizzy. Do not drive, use machinery, or do||
1419|121|P|anything that needs alertness until you can do it safely. Limit||
1419|122|P|alcoholic beverages. Talk to your doctor if you are using||
1419|123|P|marijuana (cannabis).||
1419|124|P|   Before having surgery, tell your doctor or dentist about all||
1419|125|P|the products you use (including prescription drugs,||
1419|126|P|nonprescription drugs, and herbal products).||
1419|127|P|   Older adults may be more sensitive to the side effects of this||
1419|128|P|drug, especially QT prolongation (see above).||
1419|129|P|   This medication can affect fertility in males. Ask your doctor||
1419|130|P|for more details.||
1419|131|P|   This medication must not be used during pregnancy. It may harm||
1419|132|P|an unborn baby. It is important to prevent pregnancy while using||
1419|133|P|this medication. Consult your doctor for more details and to||
1419|134|P|discuss using reliable forms of non-hormonal birth control (such||
1419|135|P|as condoms, diaphragm with spermicide) while using this||
1419|136|P|medication. If you become pregnant or think you may be pregnant,||
1419|137|P|tell your doctor right away.||
1419|138|P|   It is unknown if leuprolide passes into breast milk. Because||
1419|139|P|of the possible risk to the infant, breastfeeding is not||
1419|140|P|recommended while using this medication. Consult your doctor||
1419|141|P|before breastfeeding.||
1419|142|B|||
1419|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1419|144|I|medications work or increase your risk for serious side effects.||
1419|145|I|This document does not contain all possible drug interactions.||
1419|146|I|Keep a list of all the products you use (including||
1419|147|I|prescription/nonprescription drugs and herbal products) and share||
1419|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
1419|149|I|the dosage of any medicines without your doctor's approval.||
1419|150|I|   This medication may interfere with certain lab tests, possibly||
1419|151|I|causing false test results. Make sure lab personnel and all your||
1419|152|I|doctors know you use this drug.||
1419|153|B|||
1419|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1419|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1419|156|O|poison control center right away. US residents can call||
1419|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1419|158|B|||
1419|159|N|NOTES:  Do not share this medication with others.||
1419|160|N|   Lab and/or medical tests (such as blood testosterone level,||
1419|161|N|PSA blood test, blood glucose, cholesterol/triglyceride levels)||
1419|162|N|should be done while you are using this medication. Keep all||
1419|163|N|medical and lab appointments. Consult your doctor for more||
1419|164|N|details.||
1419|165|B|||
1419|166|D|MISSED DOSE:  It is important to get each dose of this medication||
1419|167|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
1419|168|D|right away for a new dosing schedule. Do not double the dose to||
1419|169|D|catch up.||
1419|170|B|||
1419|171|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1419|172|R|doctor's office and will not be stored at home.||
1419|173|B|||
1419|174|A|Information last revised October 2024.||
1419|175|A|Copyright(c) 2025 First Databank, Inc.||
1419|176|B|||
1421|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1421|002|Z|does NOT have all possible information about this product. This||
1421|003|Z|information does not assure that this product is safe, effective,||
1421|004|Z|or appropriate for you. This information is not individual||
1421|005|Z|medical advice and does not substitute for the advice of your||
1421|006|Z|health care professional. Always ask your health care||
1421|007|Z|professional for complete information about this product and your||
1421|008|Z|specific health needs.||
1421|009|B|||
1421|010|T|TOBRAMYCIN POWDER IN CAPSULE - ORAL INHALATION||
1421|011|F|(TOE-bra-MYE-sin)||
1421|012|B|||
1421|013|C|COMMON BRAND NAME(S): Tobi Podhaler||
1421|014|B|||
1421|015|U|USES:  This medication is used to treat people with cystic||
1421|016|U|fibrosis who have an ongoing lung infection with a certain||
1421|017|U|bacteria (Pseudomonas aeruginosa). People with cystic fibrosis||
1421|018|U|produce thick, sticky mucus that can plug up the tubes, ducts and||
1421|019|U|passageways in the lungs. This can result in serious breathing||
1421|020|U|problems and infections in the lungs.||
1421|021|U|   Tobramycin belongs to a class of drugs known as aminoglycoside||
1421|022|U|antibiotics. Tobramycin works by stopping the growth of bacteria,||
1421|023|U|including Pseudomonas aeruginosa, that commonly infect the lungs||
1421|024|U|of people with cystic fibrosis. This effect decreases lung||
1421|025|U|infections and damage, and helps to improve breathing.||
1421|026|B|||
1421|027|H|HOW TO USE:  Read the Patient Information Leaflet and instruction||
1421|028|H|sheet if available from your pharmacist before you start using||
1421|029|H|tobramycin and each time you get a refill. Learn how to use the||
1421|030|H|inhaler properly. Children may need help from an adult to use||
1421|031|H|this medication properly. If you have any questions, ask your||
1421|032|H|doctor or pharmacist.||
1421|033|H|   Do not swallow these capsules by mouth. Use the special||
1421|034|H|inhaler to inhale the powder in the capsules. Inhale this||
1421|035|H|medication by mouth as directed by your doctor, usually twice||
1421|036|H|daily (12 hours apart). Each dose is usually 4 of the||
1421|037|H|28-milligram capsules. Inhale 2 times per capsule to make sure||
1421|038|H|you inhale all of the drug. Do not breathe out into the||
1421|039|H|mouthpiece at any time. Each dose takes approximately 2 to 6||
1421|040|H|minutes.||
1421|041|H|   Inhaled tobramycin is usually given for 28 days, followed by a||
1421|042|H|28-day break when you do not inhale any tobramycin. Then if||
1421|043|H|directed by your doctor, you may start another 28-day course of||
1421|044|H|inhaled tobramycin. Do not use this medication for more than 28||
1421|045|H|days at a time. Keep track of the days that you use this||
1421|046|H|medication.||
1421|047|H|   After each dose, wipe the mouthpiece with a clean, dry cloth.||
1421|048|H|The inhaler should never be washed with water. Keep it dry and||
1421|049|H|store it in its case. Use a new inhaler every week.||
1421|050|H|   Do not inhale any other medications at the same time you||
1421|051|H|inhale tobramycin. If you are taking other inhaled medications or||
1421|052|H|doing chest physiotherapy, your doctor will let you know which||
1421|053|H|order you should receive your treatments. Inhaled tobramycin||
1421|054|H|should always be the last treatment.||
1421|055|H|   If you are using a quick-relief inhaler (such as salbutamol,||
1421|056|H|albuterol), you should inhale it 15 to 90 minutes before inhaling||
1421|057|H|tobramycin. This will help you inhale and absorb the tobramycin.||
1421|058|H|   For the best effect, use this antibiotic at evenly spaced||
1421|059|H|times. To help you remember, use this medication at the same||
1421|060|H|time(s) every day.||
1421|061|H|   Continue to use this medication until the full prescribed||
1421|062|H|amount is finished, even if symptoms disappear after a few days.||
1421|063|H|Stopping the medication too early may result in a return of the||
1421|064|H|infection.||
1421|065|H|   Tell your doctor if your condition does not get better or if||
1421|066|H|it gets worse.||
1421|067|B|||
1421|068|S|SIDE EFFECTS:  Hoarseness, cough, dry mouth, difficulty speaking,||
1421|069|S|change in taste, and changes in voice may occur. If any of these||
1421|070|S|effects last or get worse, tell your doctor or pharmacist||
1421|071|S|promptly.||
1421|072|S|   Remember that this medication has been prescribed because your||
1421|073|S|doctor has judged that the benefit to you is greater than the||
1421|074|S|risk of side effects. Many people using this medication do not||
1421|075|S|have serious side effects.||
1421|076|S|   Tell your doctor right away if you have any serious side||
1421|077|S|effects, including: signs of hearing damage (such as||
1421|078|S|ringing/roaring sounds in the ears, hearing loss, dizziness),||
1421|079|S|signs of kidney problems (such as change in the amount of urine),||
1421|080|S|coughing up blood, chest tightness/wheezing.||
1421|081|S|   A very serious allergic reaction to this drug is rare.||
1421|082|S|However, get medical help right away if you notice any symptoms||
1421|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1421|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1421|085|S|breathing.||
1421|086|S|   This is not a complete list of possible side effects. If you||
1421|087|S|notice other effects not listed above, contact your doctor or||
1421|088|S|pharmacist.||
1421|089|S|   In the US -||
1421|090|S|   Call your doctor for medical advice about side effects. You||
1421|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1421|092|S|www.fda.gov/medwatch.||
1421|093|S|   In Canada - Call your doctor for medical advice about side||
1421|094|S|effects. You may report side effects to Health Canada at||
1421|095|S|1-866-234-2345.||
1421|096|B|||
1421|097|P|PRECAUTIONS:  Before using tobramycin, tell your doctor or||
1421|098|P|pharmacist if you are allergic to it; or to other aminoglycoside||
1421|099|P|antibiotics (such as gentamicin); or if you have any other||
1421|100|P|allergies. This product may contain inactive ingredients, which||
1421|101|P|can cause allergic reactions or other problems. Talk to your||
1421|102|P|pharmacist for more details.||
1421|103|P|   Before using this medication, tell your doctor or pharmacist||
1421|104|P|your medical history, especially of: hearing problems (including||
1421|105|P|deafness, decreased hearing), kidney problems, coughing up blood,||
1421|106|P|myasthenia gravis, Parkinson's disease.||
1421|107|P|   Tobramycin may cause live bacterial vaccines (such as typhoid||
1421|108|P|vaccine) to not work well. Tell your health care professional||
1421|109|P|that you are using tobramycin before having any||
1421|110|P|immunizations/vaccinations.||
1421|111|P|   Before having surgery, tell your doctor or dentist about all||
1421|112|P|the products you use (including prescription drugs,||
1421|113|P|nonprescription drugs, and herbal products).||
1421|114|P|   During pregnancy, this medication should be used only when||
1421|115|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1421|116|P|benefits with your doctor.||
1421|117|P|   It is unknown if inhaled tobramycin passes into breast milk.||
1421|118|P|Consult your doctor before breastfeeding.||
1421|119|B|||
1421|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1421|121|I|medications work or increase your risk for serious side effects.||
1421|122|I|This document does not contain all possible drug interactions.||
1421|123|I|Keep a list of all the products you use (including||
1421|124|I|prescription/nonprescription drugs and herbal products) and share||
1421|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1421|126|I|the dosage of any medicines without your doctor's approval.||
1421|127|I|   Some products that may interact with this drug include:||
1421|128|I|botulinum toxin, neostigmine, pyridostigmine.||
1421|129|I|   Other medications that may affect hearing or cause kidney||
1421|130|I|damage may increase the risk of hearing loss or kidney problems||
1421|131|I|if taken with tobramycin. Some affected drugs include: amikacin,||
1421|132|I|gentamicin, mannitol, tacrolimus, platinum compounds such as||
1421|133|I|carboplatin/cisplatin, among others.||
1421|134|B|||
1421|135|O|OVERDOSE:  This medication will not work and may be harmful if||
1421|136|O|swallowed. If someone has overdosed and has serious symptoms such||
1421|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1421|138|O|poison control center right away. US residents can call||
1421|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1421|140|B|||
1421|141|N|NOTES:  Do not share this medication with others.||
1421|142|N|   Lab and/or medical tests (such as breathing tests, hearing||
1421|143|N|tests, kidney function, tobramycin levels) may be done while you||
1421|144|N|are using this medication. Keep all medical and lab appointments.||
1421|145|N|Consult your doctor for more details.||
1421|146|B|||
1421|147|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1421|148|D|If it is less than 6 hours before the next dose, skip the missed||
1421|149|D|dose. Use your next dose at the regular time. Do not double the||
1421|150|D|dose to catch up.||
1421|151|B|||
1421|152|R|STORAGE:  Store this medication at room temperature away from||
1421|153|R|moisture. Keep the capsules stored in the blister package until||
1421|154|R|right before use. Do not store in the bathroom. Keep the inhaler||
1421|155|R|in a tightly closed case when not in use. Keep all medications||
1421|156|R|away from children and pets.||
1421|157|R|   Do not flush medications down the toilet or pour them into a||
1421|158|R|drain unless instructed to do so. Properly discard this product||
1421|159|R|when it is expired or no longer needed. Consult your pharmacist||
1421|160|R|or local waste disposal company.||
1421|161|B|||
1421|162|A|Information last revised October 2024.||
1421|163|A|Copyright(c) 2025 First Databank, Inc.||
1421|164|B|||
1422|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1422|002|Z|does NOT have all possible information about this product. This||
1422|003|Z|information does not assure that this product is safe, effective,||
1422|004|Z|or appropriate for you. This information is not individual||
1422|005|Z|medical advice and does not substitute for the advice of your||
1422|006|Z|health care professional. Always ask your health care||
1422|007|Z|professional for complete information about this product and your||
1422|008|Z|specific health needs.||
1422|009|B|||
1422|010|T|RILPIVIRINE - ORAL||
1422|011|F|(RIL-pi-VIR-een)||
1422|012|B|||
1422|013|C|COMMON BRAND NAME(S): Edurant||
1422|014|B|||
1422|015|U|USES:  Rilpivirine is used with other HIV medications to help||
1422|016|U|control HIV infection. It helps to decrease the amount of HIV in||
1422|017|U|your body so your immune system can work better. This lowers your||
1422|018|U|chance of getting HIV complications (such as new infections,||
1422|019|U|cancer) and improves your quality of life. Rilpivirine is a||
1422|020|U|non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks||
1422|021|U|the virus from growing and infecting more cells.||
1422|022|U|   Rilpivirine is not a cure for HIV infection. To decrease your||
1422|023|U|risk of spreading HIV disease to others, continue to take all HIV||
1422|024|U|medications exactly as prescribed by your doctor. Use an||
1422|025|U|effective barrier method (latex or polyurethane condoms/dental||
1422|026|U|dams) during sexual activity as directed by your doctor. Do not||
1422|027|U|share personal items (such as needles/syringes, toothbrushes, and||
1422|028|U|razors) that may have contacted blood or other body fluids.||
1422|029|U|Consult your doctor or pharmacist for more details.||
1422|030|B|||
1422|031|V|OTHER USES:  This section contains uses of this drug that are not||
1422|032|V|listed in the approved professional labeling for the drug but||
1422|033|V|that may be prescribed by your health care professional. Use this||
1422|034|V|drug for a condition that is listed in this section only if it||
1422|035|V|has been so prescribed by your health care professional.||
1422|036|V|   This product may also be used to lessen the risk of HIV||
1422|037|V|infection after contact with the virus (for example, due to a||
1422|038|V|needle stick). Ask your doctor for more details.||
1422|039|B|||
1422|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1422|041|H|from your pharmacist before you start using rilpivirine and each||
1422|042|H|time you get a refill. If you have any questions, ask your doctor||
1422|043|H|or pharmacist.||
1422|044|H|   Do not change dosage forms of this medication without checking||
1422|045|H|with your doctor or pharmacist.||
1422|046|H|   Take this medication by mouth with a meal as directed by your||
1422|047|H|doctor, usually once daily. The dosage may be based on other||
1422|048|H|medications you are taking. Be sure to tell your doctor and||
1422|049|H|pharmacist about all the products you use (including prescription||
1422|050|H|drugs, nonprescription drugs, and herbal products).||
1422|051|H|   Medications that reduce stomach acid (such as antacids, proton||
1422|052|H|pump inhibitors/PPIs, H2 blockers) may make rilpivirine work less||
1422|053|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
1422|054|H|using this medication. If you take antacids, take the antacids at||
1422|055|H|least 2 hours before or at least 4 hours after rilpivirine. If||
1422|056|H|you take H2 blockers (such as famotidine, nizatidine), take them||
1422|057|H|at least 12 hours before or at least 4 hours after rilpivirine.||
1422|058|H|   It is very important to keep taking this medication (and other||
1422|059|H|HIV medications) exactly as prescribed by your doctor. Do not||
1422|060|H|skip any doses.||
1422|061|H|   For the best effect, take this medication at evenly spaced||
1422|062|H|times. To help you remember, take this medication at the same||
1422|063|H|time every day.||
1422|064|H|   Do not take more or less of this drug than prescribed or stop||
1422|065|H|taking it (or other HIV medicines) even for a short time unless||
1422|066|H|directed to do so by your doctor. Doing so may cause the amount||
1422|067|H|of virus to increase, make the infection more difficult to treat||
1422|068|H|(resistant), or worsen side effects.||
1422|069|B|||
1422|070|S|SIDE EFFECTS:  Headache or trouble sleeping may occur. If either||
1422|071|S|of these effects lasts or gets worse, tell your doctor or||
1422|072|S|pharmacist promptly.||
1422|073|S|   Remember that this medication has been prescribed because your||
1422|074|S|doctor has judged that the benefit to you is greater than the||
1422|075|S|risk of side effects. Many people using this medication do not||
1422|076|S|have serious side effects.||
1422|077|S|   As your immune system gets stronger, it can begin to fight off||
1422|078|S|infections you already had, possibly causing disease symptoms to||
1422|079|S|come back. You could also have symptoms if your immune system||
1422|080|S|becomes overactive. This reaction may happen at any time (soon||
1422|081|S|after starting HIV treatment or many months later). Tell your||
1422|082|S|doctor right away if you have any serious symptoms, including:||
1422|083|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1422|084|S|that doesn't go away, headaches that are severe or don't go away,||
1422|085|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1422|086|S|changes, signs of infection (such as sore throat that doesn't go||
1422|087|S|away, fever, chills, non-healing skin sores), signs of an||
1422|088|S|overactive thyroid (such as irritability, nervousness, heat||
1422|089|S|intolerance, fast/pounding/irregular heartbeat), signs of liver||
1422|090|S|disease (such as nausea/vomiting that doesn't stop, loss of||
1422|091|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1422|092|S|urine).||
1422|093|S|   Tell your doctor right away if you have any serious side||
1422|094|S|effects, including: mental/mood changes (such as depression,||
1422|095|S|thoughts of suicide).||
1422|096|S|   Rilpivirine can commonly cause a rash that is usually not||
1422|097|S|serious. However, you may not be able to tell it apart from a||
1422|098|S|rare rash that could be a sign of a severe reaction. Get medical||
1422|099|S|help right away if you develop any rash.||
1422|100|S|   A very serious allergic reaction to this drug is rare.||
1422|101|S|However, get medical help right away if you notice any symptoms||
1422|102|S|of a serious allergic reaction, including: swollen lymph nodes,||
1422|103|S|rash, itching/swelling (especially of the face/tongue/throat),||
1422|104|S|severe dizziness, trouble breathing.||
1422|105|S|   This is not a complete list of possible side effects. If you||
1422|106|S|notice other effects not listed above, contact your doctor or||
1422|107|S|pharmacist.||
1422|108|S|   In the US -||
1422|109|S|   Call your doctor for medical advice about side effects. You||
1422|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1422|111|S|www.fda.gov/medwatch.||
1422|112|S|   In Canada - Call your doctor for medical advice about side||
1422|113|S|effects. You may report side effects to Health Canada at||
1422|114|S|1-866-234-2345.||
1422|115|B|||
1422|116|P|PRECAUTIONS:  Before taking rilpivirine, tell your doctor or||
1422|117|P|pharmacist if you are allergic to it; or if you have any other||
1422|118|P|allergies. This product may contain inactive ingredients, which||
1422|119|P|can cause allergic reactions or other problems. Talk to your||
1422|120|P|pharmacist for more details.||
1422|121|P|   Before using this medication, tell your doctor or pharmacist||
1422|122|P|your medical history, especially of: kidney disease, liver||
1422|123|P|disease (such as hepatitis B, hepatitis C), mental/mood disorders||
1422|124|P|(such as depression).||
1422|125|P|   Before having surgery, tell your doctor or dentist about all||
1422|126|P|the products you use (including prescription drugs,||
1422|127|P|nonprescription drugs, and herbal products).||
1422|128|P|   Tell your doctor if you are pregnant before using this||
1422|129|P|medication. Treatment can lower the risk of passing HIV infection||
1422|130|P|to your baby. Discuss the risks and benefits with your doctor.||
1422|131|P|   This medication passes into breast milk. Because breast milk||
1422|132|P|may transmit HIV, consult your doctor before breastfeeding.||
1422|133|B|||
1422|134|I|DRUG INTERACTIONS:  See also How to Use section.||
1422|135|I|   Drug interactions may change how your medications work or||
1422|136|I|increase your risk for serious side effects. This document does||
1422|137|I|not contain all possible drug interactions. Keep a list of all||
1422|138|I|the products you use (including prescription/nonprescription||
1422|139|I|drugs and herbal products) and share it with your doctor and||
1422|140|I|pharmacist. Do not start, stop, or change the dosage of any||
1422|141|I|medicines without your doctor's approval.||
1422|142|I|   Some products that may interact with this drug are: orlistat,||
1422|143|I|other HIV NNRTIs (such as efavirenz, nevirapine), a certain||
1422|144|I|combination HIV medication||
1422|145|I|(elvitegravir/cobicistat/emtricitabine/tenofovir), proton pump||
1422|146|I|inhibitors (PPIs such as esomeprazole, lansoprazole, omeprazole,||
1422|147|I|pantoprazole, rabeprazole).||
1422|148|I|   Other medications can affect the removal of rilpivirine from||
1422|149|I|your body, which may affect how rilpivirine works. Examples||
1422|150|I|include dexamethasone, macrolide antibiotics (such as||
1422|151|I|erythromycin), rifamycins (such as rifampin, rifapentine), St.||
1422|152|I|John's wort, certain drugs used to treat seizures (such as||
1422|153|I|carbamazepine, oxcarbazepine, phenobarbital, phenytoin,||
1422|154|I|primidone), among others.||
1422|155|B|||
1422|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1422|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1422|158|O|poison control center right away. US residents can call||
1422|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1422|160|O|Symptoms of overdose may include: fast/irregular heartbeat,||
1422|161|O|severe dizziness, fainting.||
1422|162|B|||
1422|163|N|NOTES:  Do not share this medication with others.||
1422|164|N|   Lab and/or medical tests (such as viral load, T-cell counts,||
1422|165|N|liver function) should be done before you start taking this||
1422|166|N|medication and while you are taking it. Keep all medical and lab||
1422|167|N|appointments. Consult your doctor for more details.||
1422|168|B|||
1422|169|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
1422|170|D|you remember. If it is more than 12 hours after the missed dose,||
1422|171|D|skip the missed dose. Take your next dose at the regular time. Do||
1422|172|D|not double the dose to catch up.||
1422|173|B|||
1422|174|R|STORAGE:  Store in the original bottle at room temperature away||
1422|175|R|from light and moisture. Do not store in the bathroom. Keep all||
1422|176|R|medications away from children and pets.||
1422|177|R|   Do not flush medications down the toilet or pour them into a||
1422|178|R|drain unless instructed to do so. Properly discard this product||
1422|179|R|when it is expired or no longer needed. Consult your pharmacist||
1422|180|R|or local waste disposal company.||
1422|181|B|||
1422|182|A|Information last revised June 2025.||
1422|183|A|Copyright(c) 2025 First Databank, Inc.||
1422|184|B|||
1423|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1423|002|Z|does NOT have all possible information about this product. This||
1423|003|Z|information does not assure that this product is safe, effective,||
1423|004|Z|or appropriate for you. This information is not individual||
1423|005|Z|medical advice and does not substitute for the advice of your||
1423|006|Z|health care professional. Always ask your health care||
1423|007|Z|professional for complete information about this product and your||
1423|008|Z|specific health needs.||
1423|009|B|||
1423|010|T|FIDAXOMICIN - ORAL||
1423|011|F|(fye-DAX-oh-MYE-sin)||
1423|012|B|||
1423|013|C|COMMON BRAND NAME(S): Dificid||
1423|014|B|||
1423|015|U|USES:  This medication is used to treat a severe intestinal||
1423|016|U|condition (C. difficile-associated diarrhea) due to a certain||
1423|017|U|type of bacteria. This condition may rarely occur after taking||
1423|018|U|antibiotics. Symptoms include diarrhea that doesn't stop,||
1423|019|U|stomach/abdominal pain or cramping, and blood/mucus in your||
1423|020|U|stool. Fidaxomicin is known as a macrolide antibiotic. It works||
1423|021|U|by stopping the growth of this bacteria.||
1423|022|U|   This antibiotic works in the intestines and is not absorbed by||
1423|023|U|your body. It should only be used to treat this type of||
1423|024|U|intestinal bacterial infection. It will not work for other types||
1423|025|U|of infections, including viral infections (such as common cold,||
1423|026|U|flu). Unnecessary use or misuse of any antibiotic can lead to its||
1423|027|U|decreased effectiveness.||
1423|028|B|||
1423|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1423|030|H|from your pharmacist before you start taking fidaxomicin and each||
1423|031|H|time you get a refill. If you have any questions, ask your doctor||
1423|032|H|or pharmacist.||
1423|033|H|   Take this medication by mouth with or without food as directed||
1423|034|H|by your doctor, usually twice daily (every 12 hours). Children's||
1423|035|H|dosage is based on weight.||
1423|036|H|   If you are using the liquid form of this medication, remove||
1423|037|H|the bottle from the refrigerator 15 minutes before taking the||
1423|038|H|medication. Shake the bottle well before each dose. Carefully||
1423|039|H|measure the dose using a special measuring device/spoon. Do not||
1423|040|H|use a household spoon because you may not get the correct dose.||
1423|041|H|   For the best effect, take this antibiotic at evenly spaced||
1423|042|H|times. To help you remember, take this medication at the same||
1423|043|H|time(s) every day.||
1423|044|H|   Continue to take this medication until the full prescribed||
1423|045|H|amount is finished, even if symptoms disappear after a few days.||
1423|046|H|Stopping the medication too early may result in a return of the||
1423|047|H|infection.||
1423|048|H|   Tell your doctor if your condition lasts or gets worse.||
1423|049|B|||
1423|050|S|SIDE EFFECTS:  Nausea, vomiting, or stomach/abdominal pain may||
1423|051|S|occur. If any of these effects last or get worse, tell your||
1423|052|S|doctor or pharmacist promptly.||
1423|053|S|   Remember that this medication has been prescribed because your||
1423|054|S|doctor has judged that the benefit to you is greater than the||
1423|055|S|risk of side effects. Many people using this medication do not||
1423|056|S|have serious side effects.||
1423|057|S|   Tell your doctor right away if you have any serious side||
1423|058|S|effects, including: black/tarry/bloody stools, vomit that looks||
1423|059|S|like coffee grounds, signs of infection (such as sore throat that||
1423|060|S|doesn't go away, fever, chills), unusual tiredness.||
1423|061|S|   A very serious allergic reaction to this drug is rare.||
1423|062|S|However, get medical help right away if you notice any symptoms||
1423|063|S|of a serious allergic reaction, including: rash, itching/swelling||
1423|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1423|065|S|breathing.||
1423|066|S|   This is not a complete list of possible side effects. If you||
1423|067|S|notice other effects not listed above, contact your doctor or||
1423|068|S|pharmacist.||
1423|069|S|   In the US -||
1423|070|S|   Call your doctor for medical advice about side effects. You||
1423|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1423|072|S|www.fda.gov/medwatch.||
1423|073|S|   In Canada - Call your doctor for medical advice about side||
1423|074|S|effects. You may report side effects to Health Canada at||
1423|075|S|1-866-234-2345.||
1423|076|B|||
1423|077|P|PRECAUTIONS:  Before taking fidaxomicin, tell your doctor or||
1423|078|P|pharmacist if you are allergic to it; or to other macrolide||
1423|079|P|antibiotics (such as azithromycin, clarithromycin); or if you||
1423|080|P|have any other allergies. This product may contain inactive||
1423|081|P|ingredients, which can cause allergic reactions or other||
1423|082|P|problems. Talk to your pharmacist for more details.||
1423|083|P|   Before using this medication, tell your doctor or pharmacist||
1423|084|P|your medical history.||
1423|085|P|   Fidaxomicin may cause live bacterial vaccines (such as typhoid||
1423|086|P|vaccine) to not work well. Tell your health care professional||
1423|087|P|that you are using fidaxomicin before having any||
1423|088|P|immunizations/vaccinations.||
1423|089|P|   Before having surgery, tell your doctor or dentist about all||
1423|090|P|the products you use (including prescription drugs,||
1423|091|P|nonprescription drugs, and herbal products).||
1423|092|P|   During pregnancy, this medication should be used only when||
1423|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
1423|094|P|   It is unknown if this drug passes into breast milk. Consult||
1423|095|P|your doctor before breastfeeding.||
1423|096|B|||
1423|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1423|098|I|medications work or increase your risk for serious side effects.||
1423|099|I|This document does not contain all possible drug interactions.||
1423|100|I|Keep a list of all the products you use (including||
1423|101|I|prescription/nonprescription drugs and herbal products) and share||
1423|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
1423|103|I|the dosage of any medicines without your doctor's approval.||
1423|104|B|||
1423|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1423|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1423|107|O|poison control center right away. US residents can call||
1423|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1423|109|B|||
1423|110|N|NOTES:  Do not share this medication with others.||
1423|111|N|   This medication has been prescribed for your current condition||
1423|112|N|only. Do not use it later for another infection unless your||
1423|113|N|doctor tells you to.||
1423|114|N|   Lab and/or medical tests (such as stool sample tests) may be||
1423|115|N|done while you are taking this medication. Keep all medical and||
1423|116|N|lab appointments. Consult your doctor for more details.||
1423|117|B|||
1423|118|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1423|119|D|remember. If it is near the time of the next dose, skip the||
1423|120|D|missed dose. Take your next dose at the regular time. Do not||
1423|121|D|double the dose to catch up.||
1423|122|B|||
1423|123|R|STORAGE:  Store the tablets at room temperature away from light||
1423|124|R|and moisture. Do not store in the bathroom. Store the liquid||
1423|125|R|medication in the original bottle in the refrigerator. Discard||
1423|126|R|the liquid medication after 12 days. Keep all medications away||
1423|127|R|from children and pets.||
1423|128|R|   Do not flush medications down the toilet or pour them into a||
1423|129|R|drain unless instructed to do so. Properly discard this product||
1423|130|R|when it is expired or no longer needed. Consult your pharmacist||
1423|131|R|or local waste disposal company.||
1423|132|B|||
1423|133|A|Information last revised August 2024.||
1423|134|A|Copyright(c) 2025 First Databank, Inc.||
1423|135|B|||
1425|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1425|002|Z|does NOT have all possible information about this product. This||
1425|003|Z|information does not assure that this product is safe, effective,||
1425|004|Z|or appropriate for you. This information is not individual||
1425|005|Z|medical advice and does not substitute for the advice of your||
1425|006|Z|health care professional. Always ask your health care||
1425|007|Z|professional for complete information about this product and your||
1425|008|Z|specific health needs.||
1425|009|B|||
1425|010|T|VEMURAFENIB - ORAL||
1425|011|F|(VEM-ue-RAF-e-nib)||
1425|012|B|||
1425|013|C|COMMON BRAND NAME(S): Zelboraf||
1425|014|B|||
1425|015|U|USES:  Vemurafenib is used to treat a type of skin cancer||
1425|016|U|(melanoma). It is also used to treat a rare type of blood cell||
1425|017|U|cancer called Erdheim-Chester disease. These cancer cells have a||
1425|018|U|certain type of abnormal "BRAF" gene. Vemurafenib works by||
1425|019|U|slowing the growth of certain cancer cells. It belongs to a class||
1425|020|U|of drugs known as kinase inhibitors.||
1425|021|B|||
1425|022|H|HOW TO USE:  Read the Medication Guide provided by your||
1425|023|H|pharmacist before you start taking vemurafenib and each time you||
1425|024|H|get a refill. If you have any questions, ask your doctor or||
1425|025|H|pharmacist.||
1425|026|H|   Take this medication by mouth with or without food as directed||
1425|027|H|by your doctor, usually twice daily about 12 hours apart. Swallow||
1425|028|H|whole with a glass of water. Do not crush or chew this||
1425|029|H|medication. If you vomit after taking your dose, do not take an||
1425|030|H|extra dose of this medication. Take the next dose of the||
1425|031|H|medication at the regularly scheduled time.||
1425|032|H|   The dosage is based on your medical condition, response to||
1425|033|H|treatment, and other medications you may be taking. Be sure to||
1425|034|H|tell your doctor and pharmacist about all the products you use||
1425|035|H|(including prescription drugs, nonprescription drugs, and herbal||
1425|036|H|products). Do not increase your dose or use this drug more often||
1425|037|H|or for longer than prescribed. Your condition will not improve||
1425|038|H|any faster, and your risk of side effects will increase.||
1425|039|H|   Take this medication regularly to get the most benefit from||
1425|040|H|it. To help you remember, take it at the same times each day.||
1425|041|H|   Tell your doctor if your condition lasts or gets worse.||
1425|042|H|   Since this drug can be absorbed through the skin and lungs and||
1425|043|H|may harm an unborn baby, women who are pregnant or who may become||
1425|044|H|pregnant should not handle this medication or breathe the dust||
1425|045|H|from the tablets.||
1425|046|B|||
1425|047|S|SIDE EFFECTS:  Hair loss, dry skin, headache, nausea, vomiting,||
1425|048|S|diarrhea, swelling of ankles/feet/hands, or joint/muscle pain may||
1425|049|S|occur. If any of these effects last or get worse, tell your||
1425|050|S|doctor or pharmacist promptly.||
1425|051|S|   Remember that this medication has been prescribed because your||
1425|052|S|doctor has judged that the benefit to you is greater than the||
1425|053|S|risk of side effects. Many people using this medication do not||
1425|054|S|have serious side effects.||
1425|055|S|   Vemurafenib may cause other types of skin cancer (such as||
1425|056|S|cutaneous squamous cell carcinoma and melanoma) that usually does||
1425|057|S|not spread to other parts of the body. (See also Notes section.)||
1425|058|S|Tell your doctor right away if you have any skin changes||
1425|059|S|including: new wart, skin sore, change in size/color of a mole,||
1425|060|S|skin bump that bleeds or does not heal.||
1425|061|S|   Rarely, vemurafenib may also cause or worsen other types of||
1425|062|S|cancer (such as non-cutaneous squamous cell carcinomas of the||
1425|063|S|head and neck; cancers with RAS mutations, such as certain types||
1425|064|S|of leukemias). Consult your doctor for more details.||
1425|065|S|   Get medical help right away if you have any very serious side||
1425|066|S|effects, including: eye pain/swelling/redness, vision changes||
1425|067|S|(such as blurred vision, blind spot/shadows in the center of your||
1425|068|S|vision, sensitivity to light), fast/irregular heartbeat, severe||
1425|069|S|dizziness, fainting, liver problems (symptoms such as loss of||
1425|070|S|appetite, extreme tiredness, stomach/abdominal pain, dark urine,||
1425|071|S|yellowing eyes/skin), pain/trouble swallowing, heartburn, signs||
1425|072|S|of kidney problems (such as change in the amount of urine,||
1425|073|S|pink/bloody urine).||
1425|074|S|   Vemurafenib can commonly cause a rash that is usually not||
1425|075|S|serious. However, you may not be able to tell it apart from a||
1425|076|S|rash that could be a sign of a severe reaction. Tell your doctor||
1425|077|S|right away if you develop any rash.||
1425|078|S|   A very serious allergic reaction to this drug is rare.||
1425|079|S|However, get medical help right away if you notice any symptoms||
1425|080|S|of a serious allergic reaction, including: fever, swollen lymph||
1425|081|S|nodes, rash, itching/swelling (especially of the||
1425|082|S|face/tongue/throat), severe dizziness, trouble breathing.||
1425|083|S|   This is not a complete list of possible side effects. If you||
1425|084|S|notice other effects not listed above, contact your doctor or||
1425|085|S|pharmacist.||
1425|086|S|   In the US -||
1425|087|S|   Call your doctor for medical advice about side effects. You||
1425|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1425|089|S|www.fda.gov/medwatch.||
1425|090|S|   In Canada - Call your doctor for medical advice about side||
1425|091|S|effects. You may report side effects to Health Canada at||
1425|092|S|1-866-234-2345.||
1425|093|B|||
1425|094|P|PRECAUTIONS:  Before taking vemurafenib, tell your doctor or||
1425|095|P|pharmacist if you are allergic to it; or if you have any other||
1425|096|P|allergies. This product may contain inactive ingredients, which||
1425|097|P|can cause allergic reactions or other problems. Talk to your||
1425|098|P|pharmacist for more details.||
1425|099|P|   Before using this medication, tell your doctor or pharmacist||
1425|100|P|your medical history, especially of: radiation therapy.||
1425|101|P|   Vemurafenib may cause a condition that affects the heart||
1425|102|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1425|103|P|serious (rarely fatal) fast/irregular heartbeat and other||
1425|104|P|symptoms (such as severe dizziness, fainting) that need medical||
1425|105|P|attention right away.||
1425|106|P|   The risk of QT prolongation may be increased if you have||
1425|107|P|certain medical conditions or are taking other drugs that may||
1425|108|P|cause QT prolongation. Before using vemurafenib, tell your doctor||
1425|109|P|or pharmacist of all the drugs you take and if you have any of||
1425|110|P|the following conditions: certain heart problems (heart failure,||
1425|111|P|slow heartbeat, QT prolongation in the EKG), family history of||
1425|112|P|certain heart problems (QT prolongation in the EKG, sudden||
1425|113|P|cardiac death).||
1425|114|P|   Low levels of potassium or magnesium in the blood may also||
1425|115|P|increase your risk of QT prolongation. This risk may increase if||
1425|116|P|you use certain drugs (such as diuretics/"water pills") or if you||
1425|117|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1425|118|P|Talk to your doctor about using vemurafenib safely.||
1425|119|P|   This medication may make you more sensitive to the sun. Limit||
1425|120|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1425|121|P|sunscreen and wear protective clothing when outdoors. Tell your||
1425|122|P|doctor right away if you get sunburned or have skin||
1425|123|P|blisters/redness.||
1425|124|P|   Before having surgery, tell your doctor or dentist about all||
1425|125|P|the products you use (including prescription drugs,||
1425|126|P|nonprescription drugs, and herbal products).||
1425|127|P|   Older adults may be more sensitive to the side effects of this||
1425|128|P|drug, especially skin changes, nausea, decreased appetite,||
1425|129|P|swelling of ankles/feet/hands, and QT prolongation (see above).||
1425|130|P|   Tell your doctor if you are pregnant or plan to become||
1425|131|P|pregnant. You should not become pregnant while using vemurafenib.||
1425|132|P|Vemurafenib may harm an unborn baby. Ask about reliable forms of||
1425|133|P|birth control while using this medication and for 2 weeks after||
1425|134|P|the last dose. If you become pregnant, talk to your doctor right||
1425|135|P|away about the risks and benefits of this medication.||
1425|136|P|   It is unknown if this medication passes into breast milk.||
1425|137|P|Because of possible risk to the infant, breastfeeding is not||
1425|138|P|recommended while using this medication and for 2 weeks after the||
1425|139|P|last dose. Consult your doctor before breastfeeding.||
1425|140|B|||
1425|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1425|142|I|medications work or increase your risk for serious side effects.||
1425|143|I|This document does not contain all possible drug interactions.||
1425|144|I|Keep a list of all the products you use (including||
1425|145|I|prescription/nonprescription drugs and herbal products) and share||
1425|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
1425|147|I|the dosage of any medicines without your doctor's approval.||
1425|148|I|   A product that may interact with this drug is: ipilimumab.||
1425|149|I|   Many drugs besides vemurafenib may affect the heart rhythm (QT||
1425|150|I|prolongation), including amiodarone, dofetilide, quinidine,||
1425|151|I|procainamide, sotalol, and certain antipsychotic medications||
1425|152|I|(such as pimozide, thioridazine, ziprasidone), among others.||
1425|153|I|   Other medications can affect the removal of vemurafenib from||
1425|154|I|your body, which may affect how vemurafenib works. Examples||
1425|155|I|include azole antifungals (such as ketoconazole, itraconazole),||
1425|156|I|macrolide antibiotics (such as clarithromycin), nefazodone, HIV||
1425|157|I|protease inhibitors (such as atazanavir), ritonavir, St. John's||
1425|158|I|wort, telithromycin, among others.||
1425|159|I|   Vemurafenib can slow down the removal of other medications||
1425|160|I|from your body, which may affect how they work. Examples of||
1425|161|I|affected drugs include caffeine, fezolinetant, warfarin, among||
1425|162|I|others.||
1425|163|B|||
1425|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1425|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1425|166|O|poison control center right away. US residents can call||
1425|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1425|168|B|||
1425|169|N|NOTES:  Do not share this medication with others.||
1425|170|N|   Lab and/or medical tests (such as BRAF testing, liver/kidney||
1425|171|N|function, EKG, blood mineral levels) should be done before you||
1425|172|N|start taking this medication and while you are taking it. Keep||
1425|173|N|all appointments as it is important to have regular skin exams||
1425|174|N|(such as every 2 months) while taking and for up to 6 months||
1425|175|N|after stopping treatment with vemurafenib. Consult your doctor||
1425|176|N|for more details.||
1425|177|B|||
1425|178|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1425|179|D|remember. If it is within 4 hours of the next dose, skip the||
1425|180|D|missed dose. Take your next dose at the regular time. Do not||
1425|181|D|double the dose to catch up.||
1425|182|B|||
1425|183|R|STORAGE:  Store in the original container at room temperature||
1425|184|R|away from light and moisture. Do not store in the bathroom. Keep||
1425|185|R|all medication away from children and pets.||
1425|186|R|   Do not flush medications down the toilet or pour them into a||
1425|187|R|drain unless instructed to do so. Properly discard this product||
1425|188|R|when it is expired or no longer needed. Consult your pharmacist||
1425|189|R|or local waste disposal company.||
1425|190|B|||
1425|191|A|Information last revised January 2025.||
1425|192|A|Copyright(c) 2025 First Databank, Inc.||
1425|193|B|||
1426|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1426|002|Z|does NOT have all possible information about this product. This||
1426|003|Z|information does not assure that this product is safe, effective,||
1426|004|Z|or appropriate for you. This information is not individual||
1426|005|Z|medical advice and does not substitute for the advice of your||
1426|006|Z|health care professional. Always ask your health care||
1426|007|Z|professional for complete information about this product and your||
1426|008|Z|specific health needs.||
1426|009|B|||
1426|010|T|BELATACEPT - INJECTION||
1426|011|F|(bel-AT-a-sept)||
1426|012|B|||
1426|013|C|COMMON BRAND NAME(S): Nulojix||
1426|014|B|||
1426|015|W|WARNING:  This medication may increase the risk for developing||
1426|016|W|serious (even fatal) infections or certain cancers after||
1426|017|W|receiving a kidney transplant. Belatacept may also increase the||
1426|018|W|risk for developing a certain medical condition, post-transplant||
1426|019|W|lymphoproliferative disorder (PTLD), which can become a type of||
1426|020|W|cancer. The risk is greater in people who have not previously||
1426|021|W|been exposed to a certain virus (Epstein-Barr virus) that causes||
1426|022|W|a common mild infection, usually before adulthood. Before||
1426|023|W|starting treatment with this medication, your doctor should test||
1426|024|W|you to check if you have had previous exposure to Epstein-Barr||
1426|025|W|virus.||
1426|026|W|   This medication is not recommended for use to help prevent||
1426|027|W|organ rejection after a liver transplant.||
1426|028|B|||
1426|029|U|USES:  Belatacept is used to help prevent organ rejection in||
1426|030|U|people who have received a kidney transplant. It is used along||
1426|031|U|with other medications (such as mycophenolate, corticosteroids)||
1426|032|U|to allow your new organ to function normally. Belatacept belongs||
1426|033|U|to a class of drugs known as immunosuppressants. It works by||
1426|034|U|weakening your body's natural defense (immune system) to prevent||
1426|035|U|your body from rejecting the new kidney.||
1426|036|B|||
1426|037|H|HOW TO USE:  Read the Medication Guide provided by your||
1426|038|H|pharmacist before you start using belatacept and each time you||
1426|039|H|get a refill. If you have any questions, ask your doctor or||
1426|040|H|pharmacist.||
1426|041|H|   This medication is given by injection into a vein as directed||
1426|042|H|by your doctor, usually over 30 minutes. After the first dose,||
1426|043|H|this medication is given on a regular schedule as directed by||
1426|044|H|your doctor. The dosage is based on your weight.||
1426|045|H|   Do not increase your dose or use this drug more often or for||
1426|046|H|longer than prescribed. Your condition will not improve any||
1426|047|H|faster, and the risk of serious side effects may increase.||
1426|048|H|   If you are giving this medication to yourself at home, learn||
1426|049|H|all preparation and usage instructions from your health care||
1426|050|H|professional. Before using, check this product for particles or||
1426|051|H|discoloration. If either is present, do not use the liquid. Learn||
1426|052|H|how to store and discard medical supplies safely.||
1426|053|H|   This medication can increase your risk for serious (even||
1426|054|H|fatal) infections, such as cytomegalovirus or pneumocystis. To||
1426|055|H|help prevent these serious infections, your doctor may direct you||
1426|056|H|to also take other medications along with belatacept. Ask your||
1426|057|H|doctor for details. (See also Precautions section.)||
1426|058|H|   Use this medication regularly to get the most benefit from it.||
1426|059|H|To help you remember, mark your calendar with a reminder.||
1426|060|B|||
1426|061|S|SIDE EFFECTS:  See also Warning section.||
1426|062|S|   Headache, nausea, or diarrhea may occur. If any of these||
1426|063|S|effects last or get worse, tell your doctor or pharmacist||
1426|064|S|promptly.||
1426|065|S|   Remember that this medication has been prescribed because your||
1426|066|S|doctor has judged that the benefit to you is greater than the||
1426|067|S|risk of side effects. Many people using this medication do not||
1426|068|S|have serious side effects.||
1426|069|S|   Tell your doctor right away if you have any serious side||
1426|070|S|effects, including: signs of kidney problems (such as change in||
1426|071|S|the amount of urine).||
1426|072|S|   Because belatacept works by weakening the immune system, it||
1426|073|S|may lower your ability to fight infections. This may make you||
1426|074|S|more likely to get a serious (rarely fatal) infection or make any||
1426|075|S|infection you have worse. Tell your doctor right away if you||
1426|076|S|develop any signs of an infection (such as sore throat that||
1426|077|S|doesn't go away, fever, chills).||
1426|078|S|   This drug increases the risk of a rare and possibly fatal||
1426|079|S|brain infection (progressive multifocal leukoencephalopathy-PML).||
1426|080|S|Tell your doctor right away if you develop symptoms such as:||
1426|081|S|clumsiness, difficulty speaking, problems with balance, sudden||
1426|082|S|change in your thinking (such as confusion, difficulty||
1426|083|S|concentrating, memory loss), vision changes, weakness of the arms||
1426|084|S|and legs that gets worse.||
1426|085|S|   The immune system is also important in preventing and||
1426|086|S|controlling cancer. Very rarely, patients using belatacept have||
1426|087|S|developed cancers (such as lymphoma, skin cancer). Tell your||
1426|088|S|doctor right away if you develop symptoms such as: new skin||
1426|089|S|lesion or bump, change in size or color of a mole, night sweats,||
1426|090|S|swollen lymph nodes, unexplained weight loss, unusual tiredness.||
1426|091|S|   A very serious allergic reaction to this drug is rare.||
1426|092|S|However, get medical help right away if you notice any symptoms||
1426|093|S|of a serious allergic reaction, including: rash, itching/swelling||
1426|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1426|095|S|breathing.||
1426|096|S|   This is not a complete list of possible side effects. If you||
1426|097|S|notice other effects not listed above, contact your doctor or||
1426|098|S|pharmacist.||
1426|099|S|   In the US -||
1426|100|S|   Call your doctor for medical advice about side effects. You||
1426|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1426|102|S|www.fda.gov/medwatch.||
1426|103|S|   In Canada - Call your doctor for medical advice about side||
1426|104|S|effects. You may report side effects to Health Canada at||
1426|105|S|1-866-234-2345.||
1426|106|B|||
1426|107|P|PRECAUTIONS:  Before using belatacept, tell your doctor or||
1426|108|P|pharmacist if you are allergic to it; or if you have any other||
1426|109|P|allergies. This product may contain inactive ingredients, which||
1426|110|P|can cause allergic reactions or other problems. Talk to your||
1426|111|P|pharmacist for more details.||
1426|112|P|   Before using this medication, tell your doctor or pharmacist||
1426|113|P|your medical history, especially of: current/recent/returning||
1426|114|P|infection (such as tuberculosis, hepatitis, cytomegalovirus-CMV||
1426|115|P|infection), cancer, immune system disorder (such as HIV||
1426|116|P|infection, bone marrow disorder).||
1426|117|P|   Belatacept can make you more likely to get infections or may||
1426|118|P|make current infections worse. Stay away from anyone who has an||
1426|119|P|infection that may easily spread (such as chickenpox, COVID-19,||
1426|120|P|measles, flu). Talk to your doctor if you have been exposed to an||
1426|121|P|infection or for more details.||
1426|122|P|   Tell your health care professional that you are using||
1426|123|P|belatacept before having any immunizations/vaccinations. Avoid||
1426|124|P|contact with people who have recently received live vaccines||
1426|125|P|(such as flu vaccine inhaled through the nose).||
1426|126|P|   Since this medication may increase your risk of developing||
1426|127|P|skin cancer, limit your time in the sun. Avoid tanning booths and||
1426|128|P|sunlamps. Use sunscreen and wear protective clothing when||
1426|129|P|outdoors.||
1426|130|P|   Before having surgery, tell your doctor or dentist about all||
1426|131|P|the products you use (including prescription drugs,||
1426|132|P|nonprescription drugs, and herbal products).||
1426|133|P|   Tell your doctor if you are pregnant or if you plan to become||
1426|134|P|pregnant. During pregnancy, this medication should be used only||
1426|135|P|when clearly needed. Discuss the risks and benefits with your||
1426|136|P|doctor.||
1426|137|P|   It is unknown if this medication passes into breast milk.||
1426|138|P|Consult your doctor before breastfeeding.||
1426|139|B|||
1426|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1426|141|I|medications work or increase your risk for serious side effects.||
1426|142|I|This document does not contain all possible drug interactions.||
1426|143|I|Keep a list of all the products you use (including||
1426|144|I|prescription/nonprescription drugs and herbal products) and share||
1426|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
1426|146|I|the dosage of any medicines without your doctor's approval.||
1426|147|I|   Some products that may interact with this drug include: other||
1426|148|I|drugs that weaken the immune system/increase the risk of||
1426|149|I|infection (such as natalizumab, rituximab).||
1426|150|B|||
1426|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1426|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1426|153|O|poison control center right away. US residents can call||
1426|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1426|155|B|||
1426|156|N|NOTES:  Lab and/or medical tests (such as kidney function,||
1426|157|N|complete blood count) should be done while you are using this||
1426|158|N|medication. Keep all medical and lab appointments. Consult your||
1426|159|N|doctor for more details.||
1426|160|B|||
1426|161|D|MISSED DOSE:  It is important to get each dose of this medication||
1426|162|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1426|163|D|right away for a new dosing schedule. Do not double the dose to||
1426|164|D|catch up.||
1426|165|B|||
1426|166|R|STORAGE:  Consult the product instructions and your pharmacist||
1426|167|R|for storage details. Keep all medications away from children and||
1426|168|R|pets.||
1426|169|R|   Do not flush medications down the toilet or pour them into a||
1426|170|R|drain unless instructed to do so. Properly discard this product||
1426|171|R|when it is expired or no longer needed. Consult your pharmacist||
1426|172|R|or local waste disposal company.||
1426|173|B|||
1426|174|M|MEDICAL ALERT:  Your condition can cause complications in a||
1426|175|M|medical emergency. For information about enrolling in MedicAlert,||
1426|176|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1426|177|B|||
1426|178|A|Information last revised May 2025.||
1426|179|A|Copyright(c) 2025 First Databank, Inc.||
1426|180|B|||
1427|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1427|002|Z|does NOT have all possible information about this product. This||
1427|003|Z|information does not assure that this product is safe, effective,||
1427|004|Z|or appropriate for you. This information is not individual||
1427|005|Z|medical advice and does not substitute for the advice of your||
1427|006|Z|health care professional. Always ask your health care||
1427|007|Z|professional for complete information about this product and your||
1427|008|Z|specific health needs.||
1427|009|B|||
1427|010|T|TICAGRELOR - ORAL||
1427|011|F|(tye-KA-grel-or)||
1427|012|B|||
1427|013|C|COMMON BRAND NAME(S): Brilinta||
1427|014|B|||
1427|015|W|WARNING:  Ticagrelor may cause serious (sometimes fatal)||
1427|016|W|bleeding. Before taking this medication, tell your doctor your||
1427|017|W|medical history, especially about any bleeding problems. Also,||
1427|018|W|before having any surgery, tell your doctor or dentist about all||
1427|019|W|the products you use, especially ticagrelor. Your doctor or||
1427|020|W|dentist will give you specific directions for when to stop taking||
1427|021|W|this medication before your surgery. See also Precautions||
1427|022|W|section.||
1427|023|W|   This medication is usually taken with low-dose aspirin,||
1427|024|W|usually 75-100 milligrams once a day. Unless otherwise directed||
1427|025|W|by your doctor, do not take more than 100 milligrams of aspirin||
1427|026|W|daily. Doing so may make ticagrelor work less well. Ask your||
1427|027|W|doctor or pharmacist for details.||
1427|028|B|||
1427|029|U|USES:  Ticagrelor is used along with low-dose aspirin to help||
1427|030|U|prevent heart attack and stroke in people with a history of heart||
1427|031|U|disease, stroke, or at increased risk for heart disease or stroke||
1427|032|U|(for example, due to diabetes, history of transient ischemic||
1427|033|U|attack-TIA). It may also prevent blood clots after certain heart||
1427|034|U|surgeries (such as stent placement).||
1427|035|U|   Ticagrelor works by blocking platelets from sticking together||
1427|036|U|and prevents them from forming harmful clots. It is an||
1427|037|U|antiplatelet drug. It keeps blood flowing smoothly in your body.||
1427|038|B|||
1427|039|H|HOW TO USE:  Read the Medication Guide provided by your||
1427|040|H|pharmacist before you start taking ticagrelor and each time you||
1427|041|H|get a refill. If you have any questions, ask your doctor or||
1427|042|H|pharmacist.||
1427|043|H|   Take this medication by mouth with or without food as directed||
1427|044|H|by your doctor, usually twice daily. The dosage and length of||
1427|045|H|treatment are based on your medical condition and response to||
1427|046|H|treatment. Take a low-dose aspirin (usually 75-100 milligrams)||
1427|047|H|once a day if directed by your doctor. Follow your doctor's||
1427|048|H|directions carefully. See also Warning section.||
1427|049|H|   If you have trouble swallowing ticagrelor, you may crush the||
1427|050|H|tablet. Mix the crushed tablet with water in a glass, then drink||
1427|051|H|the mixture right away. Refill the glass with water, stir, and||
1427|052|H|drink to make sure you take all of your dose.||
1427|053|H|   If you are giving this medication through a feeding tube, ask||
1427|054|H|your health care professional for detailed instructions on how to||
1427|055|H|properly mix and give it.||
1427|056|H|   Take this medication regularly to get the most benefit from||
1427|057|H|it. To help you remember, take it at the same times each day.||
1427|058|H|   Do not increase your dose or take this drug more often or for||
1427|059|H|longer than prescribed. Your condition will not improve any||
1427|060|H|faster, and your risk of side effects will increase.||
1427|061|H|   Keep taking this medication even if you feel well. Do not stop||
1427|062|H|taking this medication without consulting your doctor. If you||
1427|063|H|stop taking this medication early, you may have a higher risk of||
1427|064|H|getting a heart attack or stroke.||
1427|065|B|||
1427|066|S|SIDE EFFECTS:  Shortness of breath, headache, dizziness, nausea,||
1427|067|S|and nosebleed may occur. If any of these effects last or get||
1427|068|S|worse, tell your doctor or pharmacist promptly.||
1427|069|S|   Remember that this medication has been prescribed because your||
1427|070|S|doctor has judged that the benefit to you is greater than the||
1427|071|S|risk of side effects. Many people using this medication do not||
1427|072|S|have serious side effects.||
1427|073|S|   Although unlikely, serious bleeding may occur. Tell your||
1427|074|S|doctor right away if you have any serious side effects,||
1427|075|S|including: easy bruising/bleeding, bleeding that is severe or||
1427|076|S|that you cannot control (such as a severe nosebleed that you||
1427|077|S|cannot stop), bloody/black stools, vomit with blood or that looks||
1427|078|S|like coffee grounds, bloody/red/pink/dark urine.||
1427|079|S|   Tell your doctor right away if you have any serious side||
1427|080|S|effects, including: interrupted breathing during sleep.||
1427|081|S|   Get medical help right away if you have any very serious side||
1427|082|S|effects, including: fast/slow/irregular heartbeat, fainting,||
1427|083|S|confusion, trouble speaking, vision changes, signs of a blood||
1427|084|S|clotting problem (such as red/purple pinpoint-sized spots on the||
1427|085|S|skin, fever).||
1427|086|S|   A very serious allergic reaction to this drug is rare.||
1427|087|S|However, get medical help right away if you notice any symptoms||
1427|088|S|of a serious allergic reaction, including: rash, itching/swelling||
1427|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1427|090|S|breathing.||
1427|091|S|   This is not a complete list of possible side effects. If you||
1427|092|S|notice other effects not listed above, contact your doctor or||
1427|093|S|pharmacist.||
1427|094|S|   In the US -||
1427|095|S|   Call your doctor for medical advice about side effects. You||
1427|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1427|097|S|www.fda.gov/medwatch.||
1427|098|S|   In Canada - Call your doctor for medical advice about side||
1427|099|S|effects. You may report side effects to Health Canada at||
1427|100|S|1-866-234-2345.||
1427|101|B|||
1427|102|P|PRECAUTIONS:  Before taking ticagrelor, tell your doctor or||
1427|103|P|pharmacist if you are allergic to it; or if you have any other||
1427|104|P|allergies. This product may contain inactive ingredients, which||
1427|105|P|can cause allergic reactions or other problems. Talk to your||
1427|106|P|pharmacist for more details.||
1427|107|P|   Before using this medication, tell your doctor or pharmacist||
1427|108|P|your medical history, especially of: bleeding problems (such as||
1427|109|P|bleeding in the brain, hemophilia, ulcers, frequent nosebleeds),||
1427|110|P|gout, liver disease, recent surgery, serious injury/trauma, heart||
1427|111|P|rhythm problems (heart block or fast/slow/irregular heartbeat).||
1427|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1427|113|P|can make you more dizzy. Do not drive, use machinery, or do||
1427|114|P|anything that needs alertness until you can do it safely. Limit||
1427|115|P|alcoholic beverages. Talk to your doctor if you are using||
1427|116|P|marijuana (cannabis). This medicine can cause stomach bleeding.||
1427|117|P|Daily use of alcohol while using this medicine may increase your||
1427|118|P|risk for stomach bleeding.||
1427|119|P|   To lower the chance of getting cut, bruised, or injured, use||
1427|120|P|caution with sharp objects like razors and nail cutters, and||
1427|121|P|avoid activities such as contact sports.||
1427|122|P|   Before having surgery, tell your doctor or dentist about all||
1427|123|P|the products you use (including prescription drugs,||
1427|124|P|nonprescription drugs, and herbal products). Your doctor or||
1427|125|P|dentist may tell you to temporarily stop ticagrelor at least 5||
1427|126|P|days before surgery or a dental procedure. Carefully follow your||
1427|127|P|doctor's or dentist's specific directions for when to stop or||
1427|128|P|restart this medication.||
1427|129|P|   During pregnancy, this medication should be used only when||
1427|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
1427|131|P|   It is unknown if this drug passes into breast milk. Consult||
1427|132|P|your doctor before breastfeeding.||
1427|133|B|||
1427|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1427|135|I|medications work or increase your risk for serious side effects.||
1427|136|I|This document does not contain all possible drug interactions.||
1427|137|I|Keep a list of all the products you use (including||
1427|138|I|prescription/nonprescription drugs and herbal products) and share||
1427|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
1427|140|I|the dosage of any medicines without your doctor's approval.||
1427|141|I|   Some products that may interact with this drug include:||
1427|142|I|mifepristone, other drugs that can cause bleeding/bruising||
1427|143|I|(including other antiplatelet drugs such as clopidogrel, NSAIDs||
1427|144|I|such as ibuprofen/naproxen, "blood thinners" such as||
1427|145|I|dabigatran/warfarin).||
1427|146|I|   Other medications can affect the removal of ticagrelor from||
1427|147|I|your body, which may affect how ticagrelor works. Examples||
1427|148|I|include dexamethasone, nefazodone, ritonavir, telithromycin,||
1427|149|I|azole antifungals (such as itraconazole, ketoconazole), HIV||
1427|150|I|protease inhibitors (such as atazanavir), macrolide antibiotics||
1427|151|I|(such as clarithromycin), rifamycins (such as rifampin), drugs||
1427|152|I|used to treat seizures (such as carbamazepine, phenytoin), among||
1427|153|I|others.||
1427|154|I|   Check all prescription and nonprescription medicine labels||
1427|155|I|carefully since many medications contain pain relievers/fever||
1427|156|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These||
1427|157|I|drugs are similar to ticagrelor and may increase your risk of||
1427|158|I|side effects if taken together. However, if your doctor has told||
1427|159|I|you to take low-dose aspirin to prevent heart attack or stroke||
1427|160|I|(usually at dosages of 75-100 milligrams a day), you should keep||
1427|161|I|taking the aspirin unless your doctor tells you not to. Ask your||
1427|162|I|doctor or pharmacist for more details.||
1427|163|I|   This medication may interfere with certain lab tests (such as||
1427|164|I|platelet functional tests), possibly causing false test results.||
1427|165|I|Make sure lab personnel and all your doctors know you use this||
1427|166|I|drug.||
1427|167|B|||
1427|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1427|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1427|170|O|poison control center right away. US residents can call||
1427|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1427|172|O|Symptoms of overdose may include: severe bleeding, nausea,||
1427|173|O|vomiting, diarrhea, irregular heartbeat.||
1427|174|B|||
1427|175|N|NOTES:  Do not share this medication with others.||
1427|176|N|   Lab and/or medical tests (such as complete blood count) should||
1427|177|N|be done while you are taking this medication. Keep all medical||
1427|178|N|and lab appointments. Consult your doctor for more details.||
1427|179|B|||
1427|180|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1427|181|D|next dose at the regular time. Do not double the dose to catch||
1427|182|D|up.||
1427|183|B|||
1427|184|R|STORAGE:  Different brands of this medication have different||
1427|185|R|storage needs. Check the product package for instructions on how||
1427|186|R|to store your brand, or ask your pharmacist. Keep all medications||
1427|187|R|away from children and pets.||
1427|188|R|   Do not flush medications down the toilet or pour them into a||
1427|189|R|drain unless instructed to do so. Properly discard this product||
1427|190|R|when it is expired or no longer needed. Consult your pharmacist||
1427|191|R|or local waste disposal company.||
1427|192|B|||
1427|193|M|MEDICAL ALERT:  Your condition can cause complications in a||
1427|194|M|medical emergency. For information about enrolling in MedicAlert,||
1427|195|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1427|196|B|||
1427|197|A|Information last revised May 2024.||
1427|198|A|Copyright(c) 2025 First Databank, Inc.||
1427|199|B|||
1429|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1429|002|Z|does NOT have all possible information about this product. This||
1429|003|Z|information does not assure that this product is safe, effective,||
1429|004|Z|or appropriate for you. This information is not individual||
1429|005|Z|medical advice and does not substitute for the advice of your||
1429|006|Z|health care professional. Always ask your health care||
1429|007|Z|professional for complete information about this product and your||
1429|008|Z|specific health needs.||
1429|009|B|||
1429|010|T|LOTEPREDNOL OINTMENT - OPHTHALMIC||
1429|011|F|(LOE-te-PRED-nol)||
1429|012|B|||
1429|013|C|COMMON BRAND NAME(S): Lotemax||
1429|014|B|||
1429|015|U|USES:  This medication is used to treat eye inflammation and pain||
1429|016|U|after eye surgery. Loteprednol works by relieving symptoms such||
1429|017|U|as swelling, redness, and itching. It belongs to a class of drugs||
1429|018|U|known as corticosteroids.||
1429|019|B|||
1429|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1429|021|H|directed by your doctor, usually 4 times a day.||
1429|022|H|   Do not wear contact lenses while you are using this||
1429|023|H|medication. Sterilize contact lenses according to the||
1429|024|H|manufacturer's directions, and check with your doctor before you||
1429|025|H|begin using them again.||
1429|026|H|   To apply the eye ointment, wash your hands first. To avoid||
1429|027|H|contamination, do not touch the tube tip or let it touch your eye||
1429|028|H|or any other surface. Gently pull down the lower eyelid to make a||
1429|029|H|pouch. Place a one-half inch (1.5 centimeter) strip of ointment||
1429|030|H|into the pouch. Gently close the eye and roll the eyeball in all||
1429|031|H|directions to spread the medication. Try not to blink or rub your||
1429|032|H|eye.||
1429|033|H|   Repeat these steps for your other eye if so directed. Wipe the||
1429|034|H|tip of the ointment tube with a clean tissue to remove extra||
1429|035|H|medication before recapping it.||
1429|036|H|   If you are using another kind of eye medication (for example,||
1429|037|H|drops or other ointments), wait at least 5 to 10 minutes before||
1429|038|H|applying other medications. Use eye drops before eye ointments to||
1429|039|H|allow the drops to enter the eye.||
1429|040|H|   Wait several minutes for your vision to clear before driving||
1429|041|H|or operating machinery.||
1429|042|H|   Use this medication regularly to get the most benefit from it.||
1429|043|H|To help you remember, use it at the same times each day.||
1429|044|H|   The dosage and length of treatment are based on your medical||
1429|045|H|condition and response to treatment. Do not use this medication||
1429|046|H|more often or for longer than prescribed because doing so may||
1429|047|H|increase your risk of side effects.||
1429|048|H|   Continue to use this medication for the full time prescribed.||
1429|049|H|Do not stop using this medication without consulting your doctor.||
1429|050|H|Some conditions may become worse when this drug is suddenly||
1429|051|H|stopped. Your dose may need to be gradually decreased.||
1429|052|H|   Do not use this product if it becomes contaminated (for||
1429|053|H|example, ointment turns a dark color or develops particles in||
1429|054|H|it). Using contaminated eye medication can cause infection,||
1429|055|H|serious damage to the eye, and loss of vision. Contact your||
1429|056|H|doctor or pharmacist for more information.||
1429|057|H|   Tell your doctor if your condition does not get better after a||
1429|058|H|few days or if it gets worse.||
1429|059|B|||
1429|060|S|SIDE EFFECTS:  Temporary blurred vision may occur when you apply||
1429|061|S|this medication. If this effect lasts or gets worse, tell your||
1429|062|S|doctor or pharmacist promptly.||
1429|063|S|   Remember that this medication has been prescribed because your||
1429|064|S|doctor has judged that the benefit to you is greater than the||
1429|065|S|risk of side effects. Many people using this medication do not||
1429|066|S|have serious side effects.||
1429|067|S|   Use of this medication for prolonged periods or in high doses||
1429|068|S|may cause serious side effects, including serious eye problems||
1429|069|S|(such as cataracts and high pressure inside the eyes). Tell your||
1429|070|S|doctor right away if you have any serious side effects,||
1429|071|S|including: vision problems/changes, eye pain, headache,||
1429|072|S|dizziness.||
1429|073|S|   This medication may mask the signs of an eye infection. It may||
1429|074|S|also put you at greater risk of developing an eye infection,||
1429|075|S|especially with prolonged use. Report right away any new or||
1429|076|S|worsening symptoms such as eye||
1429|077|S|discharge/swelling/redness/itching/pain, vision problems/changes,||
1429|078|S|or no improvement of your current eye condition. Your doctor will||
1429|079|S|need to adjust your treatment.||
1429|080|S|   A very serious allergic reaction to this drug is rare.||
1429|081|S|However, get medical help right away if you notice any symptoms||
1429|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1429|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1429|084|S|breathing.||
1429|085|S|   This is not a complete list of possible side effects. If you||
1429|086|S|notice other effects not listed above, contact your doctor or||
1429|087|S|pharmacist.||
1429|088|S|   In the US -||
1429|089|S|   Call your doctor for medical advice about side effects. You||
1429|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1429|091|S|www.fda.gov/medwatch.||
1429|092|S|   In Canada - Call your doctor for medical advice about side||
1429|093|S|effects. You may report side effects to Health Canada at||
1429|094|S|1-866-234-2345.||
1429|095|B|||
1429|096|P|PRECAUTIONS:  Before using loteprednol, tell your doctor or||
1429|097|P|pharmacist if you are allergic to it; or if you have any other||
1429|098|P|allergies. This product may contain inactive ingredients, which||
1429|099|P|can cause allergic reactions or other problems. Talk to your||
1429|100|P|pharmacist for more details.||
1429|101|P|   Before using this medication, tell your doctor or pharmacist||
1429|102|P|your medical history, especially of: eye infections, cataracts,||
1429|103|P|glaucoma (open-angle type), severe nearsightedness (myopia),||
1429|104|P|diabetes.||
1429|105|P|   After you apply this drug, your vision may become temporarily||
1429|106|P|blurred. Do not drive, use machinery, or do anything that needs||
1429|107|P|clear vision until you can do it safely.||
1429|108|P|   Before having surgery, tell your doctor or dentist about all||
1429|109|P|the products you use (including prescription drugs,||
1429|110|P|nonprescription drugs, and herbal products).||
1429|111|P|   If you develop a new eye infection or injury, or require eye||
1429|112|P|surgery, ask your doctor if you should continue to use your||
1429|113|P|current tube of loteprednol eye ointment or start a new tube.||
1429|114|P|   This medication should not be used by children after eye||
1429|115|P|surgery. It can interfere with the child's ability to see out of||
1429|116|P|the operated eye.||
1429|117|P|   During pregnancy, this medication should be used only when||
1429|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
1429|119|P|   It is unknown if the medication in this product passes into||
1429|120|P|breast milk. Consult your doctor before breastfeeding.||
1429|121|B|||
1429|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1429|123|I|medications work or increase your risk for serious side effects.||
1429|124|I|This document does not contain all possible drug interactions.||
1429|125|I|Keep a list of all the products you use (including||
1429|126|I|prescription/nonprescription drugs and herbal products) and share||
1429|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
1429|128|I|the dosage of any medicines without your doctor's approval.||
1429|129|B|||
1429|130|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1429|131|O|has overdosed and has serious symptoms such as passing out or||
1429|132|O|trouble breathing, call 911. Otherwise, call a poison control||
1429|133|O|center right away. US residents can call 1-800-222-1222. Canada||
1429|134|O|residents can call 1-844-764-7669.||
1429|135|B|||
1429|136|N|NOTES:  Do not share this medication with others.||
1429|137|N|   This medication has been prescribed for your current condition||
1429|138|N|only. Do not use it later for another eye condition unless told||
1429|139|N|to do so by your doctor. A different medication may be necessary||
1429|140|N|in that case.||
1429|141|N|   Lab and/or medical tests (such as eye exams, measurement of||
1429|142|N|the pressure inside the eyes) may be done while you are using||
1429|143|N|this medication. Keep all medical and lab appointments. Consult||
1429|144|N|your doctor for more details.||
1429|145|B|||
1429|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1429|147|D|If it is near the time of the next dose, skip the missed dose.||
1429|148|D|Use your next dose at the regular time. Do not double the dose to||
1429|149|D|catch up.||
1429|150|B|||
1429|151|R|STORAGE:  Store at room temperature. Keep all medications away||
1429|152|R|from children and pets.||
1429|153|R|   Do not flush medications down the toilet or pour them into a||
1429|154|R|drain unless instructed to do so. Properly discard this product||
1429|155|R|when it is expired or no longer needed. Consult your pharmacist||
1429|156|R|or local waste disposal company.||
1429|157|B|||
1429|158|A|Information last revised November 2024.||
1429|159|A|Copyright(c) 2025 First Databank, Inc.||
1429|160|B|||
1430|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1430|002|Z|does NOT have all possible information about this product. This||
1430|003|Z|information does not assure that this product is safe, effective,||
1430|004|Z|or appropriate for you. This information is not individual||
1430|005|Z|medical advice and does not substitute for the advice of your||
1430|006|Z|health care professional. Always ask your health care||
1430|007|Z|professional for complete information about this product and your||
1430|008|Z|specific health needs.||
1430|009|B|||
1430|010|T|GABAPENTIN SUSTAINED-RELEASE - ORAL||
1430|011|F|(GAB-a-PEN-tin)||
1430|012|B|||
1430|013|C|COMMON BRAND NAME(S): Gralise||
1430|014|B|||
1430|015|U|USES:  This medication is used to relieve nerve pain following||
1430|016|U|shingles (a painful rash due to herpes zoster infection) in||
1430|017|U|adults. This condition is called postherpetic neuralgia.||
1430|018|U|Gabapentin belongs to a class of drugs known as antiseizure drugs||
1430|019|U|(also called anticonvulsant or antiepileptic drugs).||
1430|020|B|||
1430|021|V|OTHER USES:  This section contains uses of this drug that are not||
1430|022|V|listed in the approved professional labeling for the drug but||
1430|023|V|that may be prescribed by your health care professional. Use this||
1430|024|V|drug for a condition that is listed in this section only if it||
1430|025|V|has been so prescribed by your health care professional.||
1430|026|V|   This drug may also be used for restless legs syndrome and||
1430|027|V|other painful nerve conditions (neuropathic pain).||
1430|028|B|||
1430|029|H|HOW TO USE:  Read the Medication Guide provided by your||
1430|030|H|pharmacist before you start taking gabapentin and each time you||
1430|031|H|get a refill. If you have any questions, ask your doctor or||
1430|032|H|pharmacist.||
1430|033|H|   Take this medication by mouth as directed by your doctor,||
1430|034|H|usually once a day with the evening meal. The dosage is based on||
1430|035|H|your medical condition and response to treatment.||
1430|036|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1430|037|H|Doing so can release all of the drug at once, increasing the risk||
1430|038|H|of side effects.||
1430|039|H|   During the first 2 weeks of treatment, your doctor may||
1430|040|H|gradually increase your dose so your body can adjust to the||
1430|041|H|medication.||
1430|042|H|   Take this medication regularly to get the most benefit from||
1430|043|H|it. To help you remember, take it at the same time each day.||
1430|044|H|   Do not take this medication more often or increase your dose||
1430|045|H|without consulting your doctor. Your condition will not improve||
1430|046|H|any faster, and your risk of side effects will increase.||
1430|047|H|   Do not stop taking this medication without consulting your||
1430|048|H|doctor. Some conditions may become worse when this drug is||
1430|049|H|suddenly stopped. Also, you may experience symptoms such as||
1430|050|H|difficulty sleeping, sweating, nausea, and headache. To prevent||
1430|051|H|these symptoms while you are stopping treatment with this drug,||
1430|052|H|your doctor may reduce your dose gradually. Report any new or||
1430|053|H|worsening symptoms right away.||
1430|054|H|   Antacids containing aluminum or magnesium may interfere with||
1430|055|H|the absorption of this medication. If you are also taking an||
1430|056|H|antacid, it is best to take gabapentin at least 2 hours after||
1430|057|H|taking the antacid.||
1430|058|H|   Different forms of gabapentin (such as immediate-release,||
1430|059|H|sustained-release, enacarbil sustained-release) are absorbed in||
1430|060|H|the body differently. Do not switch from one form to the other||
1430|061|H|without consulting your doctor.||
1430|062|H|   Tell your doctor if your condition does not get better or if||
1430|063|H|it gets worse.||
1430|064|B|||
1430|065|S|SIDE EFFECTS:  Drowsiness, loss of coordination, and dizziness||
1430|066|S|may occur. If any of these effects last or get worse, tell your||
1430|067|S|doctor or pharmacist promptly.||
1430|068|S|   Remember that this medication has been prescribed because your||
1430|069|S|doctor has judged that the benefit to you is greater than the||
1430|070|S|risk of side effects. Many people using this medication do not||
1430|071|S|have serious side effects.||
1430|072|S|   Tell your doctor right away if you have any serious side||
1430|073|S|effects, including: swelling of the hands/ankles/feet.||
1430|074|S|   A small number of people who take anticonvulsants for any||
1430|075|S|condition (such as seizures, bipolar disorder, pain) may||
1430|076|S|experience depression, suicidal thoughts/attempts, or other||
1430|077|S|mental/mood problems. These effects may occur even after the||
1430|078|S|medication has been stopped. Tell your doctor right away if you||
1430|079|S|or your family/caregiver notice any unusual/sudden changes in||
1430|080|S|your mood, thoughts, or behavior including signs of depression,||
1430|081|S|suicidal thoughts/attempts, thoughts about harming yourself.||
1430|082|S|   Get medical help right away if you have any very serious side||
1430|083|S|effects, including: slow/shallow breathing.||
1430|084|S|   A very serious allergic reaction to this drug is rare.||
1430|085|S|However, get medical help right away if you notice any symptoms||
1430|086|S|of a serious allergic reaction, including: fever, swollen lymph||
1430|087|S|nodes, rash, itching/swelling (especially of the||
1430|088|S|face/tongue/throat), severe dizziness, trouble breathing.||
1430|089|S|   This is not a complete list of possible side effects. If you||
1430|090|S|notice other effects not listed above, contact your doctor or||
1430|091|S|pharmacist.||
1430|092|S|   In the US -||
1430|093|S|   Call your doctor for medical advice about side effects. You||
1430|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1430|095|S|www.fda.gov/medwatch.||
1430|096|S|   In Canada - Call your doctor for medical advice about side||
1430|097|S|effects. You may report side effects to Health Canada at||
1430|098|S|1-866-234-2345.||
1430|099|B|||
1430|100|P|PRECAUTIONS:  Before taking gabapentin, tell your doctor or||
1430|101|P|pharmacist if you are allergic to it; or to gabapentin enacarbil;||
1430|102|P|or if you have any other allergies. This product may contain||
1430|103|P|inactive ingredients, which can cause allergic reactions or other||
1430|104|P|problems. Talk to your pharmacist for more details.||
1430|105|P|   Before using this medication, tell your doctor or pharmacist||
1430|106|P|your medical history, especially of: kidney disease, mental/mood||
1430|107|P|problems (such as depression, thoughts of suicide), use/abuse of||
1430|108|P|drugs/alcohol, breathing problems (such as COPD).||
1430|109|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1430|110|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1430|111|P|machinery, or do anything that needs alertness until you can do||
1430|112|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1430|113|P|are using marijuana (cannabis).||
1430|114|P|   Before having surgery, tell your doctor or dentist about all||
1430|115|P|the products you use (including prescription drugs,||
1430|116|P|nonprescription drugs, and herbal products).||
1430|117|P|   Older adults may be more sensitive to the side effects of this||
1430|118|P|drug, especially swelling of the hands/ankles/feet, slow/shallow||
1430|119|P|breathing, dizziness, or loss of coordination. Dizziness and loss||
1430|120|P|of coordination can increase the risk of falling.||
1430|121|P|   During pregnancy, this medication should be used only when||
1430|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
1430|123|P|   Gabapentin passes into breast milk. Consult your doctor before||
1430|124|P|breastfeeding.||
1430|125|B|||
1430|126|I|DRUG INTERACTIONS:  See also How to Use section.||
1430|127|I|   Drug interactions may change how your medications work or||
1430|128|I|increase your risk for serious side effects. This document does||
1430|129|I|not contain all possible drug interactions. Keep a list of all||
1430|130|I|the products you use (including prescription/nonprescription||
1430|131|I|drugs and herbal products) and share it with your doctor and||
1430|132|I|pharmacist. Do not start, stop, or change the dosage of any||
1430|133|I|medicines without your doctor's approval.||
1430|134|I|   A product that may interact with this drug is: orlistat.||
1430|135|I|   The risk of serious side effects (such as slow/shallow||
1430|136|I|breathing, severe drowsiness/dizziness) may be increased if this||
1430|137|I|medication is taken with other products that may also cause||
1430|138|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1430|139|I|if you are using other products such as opioid pain or cough||
1430|140|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1430|141|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1430|142|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1430|143|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1430|144|I|diphenhydramine).||
1430|145|I|   Check the labels on all your medicines (such as allergy or||
1430|146|I|cough-and-cold products) because they may contain ingredients||
1430|147|I|that cause drowsiness. Ask your pharmacist about using those||
1430|148|I|products safely.||
1430|149|I|   Do not use this medication with other medications that contain||
1430|150|I|gabapentin (including gabapentin enacarbil).||
1430|151|I|   This medication may interfere with certain lab tests (such as||
1430|152|I|urine protein), possibly causing false test results. Make sure||
1430|153|I|lab personnel and all your doctors know you use this drug.||
1430|154|B|||
1430|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1430|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1430|157|O|poison control center right away. US residents can call||
1430|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1430|159|O|Symptoms of overdose may include: vision changes, severe||
1430|160|O|drowsiness, trouble speaking, weakness.||
1430|161|B|||
1430|162|N|NOTES:  Do not share this medication with others.||
1430|163|B|||
1430|164|D|MISSED DOSE:  If you miss a dose, take it with food as soon as||
1430|165|D|you remember. If it is near the time of the next dose, skip the||
1430|166|D|missed dose. Take your next dose at the regular time. Do not||
1430|167|D|double the dose to catch up.||
1430|168|B|||
1430|169|R|STORAGE:  Store at room temperature away from light and moisture.||
1430|170|R|Do not store in the bathroom. Keep all medications away from||
1430|171|R|children and pets.||
1430|172|R|   Do not flush medications down the toilet or pour them into a||
1430|173|R|drain unless instructed to do so. Properly discard this product||
1430|174|R|when it is expired or no longer needed. Consult your pharmacist||
1430|175|R|or local waste disposal company.||
1430|176|B|||
1430|177|A|Information last revised May 2025.||
1430|178|A|Copyright(c) 2025 First Databank, Inc.||
1430|179|B|||
1431|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1431|002|Z|does NOT have all possible information about this product. This||
1431|003|Z|information does not assure that this product is safe, effective,||
1431|004|Z|or appropriate for you. This information is not individual||
1431|005|Z|medical advice and does not substitute for the advice of your||
1431|006|Z|health care professional. Always ask your health care||
1431|007|Z|professional for complete information about this product and your||
1431|008|Z|specific health needs.||
1431|009|B|||
1431|010|T|SODIUM CHLORIDE FLUSH - INJECTION||
1431|011|F|(SOE-dee-um KLOR-ide)||
1431|012|B|||
1431|013|U|USES:  This product is used to help prevent IV catheters from||
1431|014|U|becoming blocked and also to help remove any medication that may||
1431|015|U|be left at the catheter site.||
1431|016|B|||
1431|017|H|HOW TO USE:  This product is given by injection into the IV||
1431|018|H|catheter as directed by your doctor.||
1431|019|H|   If you are using this product at home, learn all preparation||
1431|020|H|and usage instructions from your health care professional. Before||
1431|021|H|using, check this product for particles or discoloration. If||
1431|022|H|either is present, do not use the liquid. Learn how to store and||
1431|023|H|discard medical supplies safely.||
1431|024|H|   Use this medication regularly to get the most benefit from it.||
1431|025|H|To help you remember, use it at the same times each day.||
1431|026|H|   Tell your doctor if you have any signs of an infection near||
1431|027|H|the catheter site (such as tenderness, pain, swelling, redness,||
1431|028|H|warmth).||
1431|029|B|||
1431|030|S|SIDE EFFECTS:  Mild irritation at the injection site may occur.||
1431|031|S|If this effect lasts or gets worse, tell your doctor or||
1431|032|S|pharmacist promptly.||
1431|033|S|   Remember that this medication has been prescribed because your||
1431|034|S|doctor has judged that the benefit to you is greater than the||
1431|035|S|risk of side effects. Many people using this medication do not||
1431|036|S|have serious side effects.||
1431|037|S|   A very serious allergic reaction to this drug is rare.||
1431|038|S|However, get medical help right away if you notice any symptoms||
1431|039|S|of a serious allergic reaction, including: rash, itching/swelling||
1431|040|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1431|041|S|breathing.||
1431|042|S|   This is not a complete list of possible side effects. If you||
1431|043|S|notice other effects not listed above, contact your doctor or||
1431|044|S|pharmacist.||
1431|045|S|   In the US -||
1431|046|S|   Call your doctor for medical advice about side effects. You||
1431|047|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1431|048|S|www.fda.gov/medwatch.||
1431|049|S|   In Canada - Call your doctor for medical advice about side||
1431|050|S|effects. You may report side effects to Health Canada at||
1431|051|S|1-866-234-2345.||
1431|052|B|||
1431|053|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1431|054|P|pharmacist if you are allergic to it; or if you have any other||
1431|055|P|allergies. This product may contain inactive ingredients, which||
1431|056|P|can cause allergic reactions or other problems. Talk to your||
1431|057|P|pharmacist for more details.||
1431|058|P|   Before using this medication, tell your doctor or pharmacist||
1431|059|P|your medical history.||
1431|060|P|   Before having surgery, tell your doctor or dentist about all||
1431|061|P|the products you use (including prescription drugs,||
1431|062|P|nonprescription drugs, and herbal products).||
1431|063|P|   This medication is considered safe to use during pregnancy.||
1431|064|P|   This medication is considered safe to use during||
1431|065|P|breastfeeding.||
1431|066|B|||
1431|067|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1431|068|I|medications work or increase your risk for serious side effects.||
1431|069|I|This document does not contain all possible drug interactions.||
1431|070|I|Keep a list of all the products you use (including||
1431|071|I|prescription/nonprescription drugs and herbal products) and share||
1431|072|I|it with your doctor and pharmacist. Do not start, stop, or change||
1431|073|I|the dosage of any medicines without your doctor's approval.||
1431|074|B|||
1431|075|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1431|076|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1431|077|O|poison control center right away. US residents can call||
1431|078|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1431|079|B|||
1431|080|N|NOTES:  Do not share this medication with others.||
1431|081|B|||
1431|082|D|MISSED DOSE:  It is important to get each dose of this medication||
1431|083|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1431|084|D|right away for a new dosing schedule.||
1431|085|B|||
1431|086|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
1431|087|R|medications away from children and pets.||
1431|088|R|   Do not flush medications down the toilet or pour them into a||
1431|089|R|drain unless instructed to do so. Properly discard this product||
1431|090|R|when it is expired or no longer needed. Consult your pharmacist||
1431|091|R|or local waste disposal company.||
1431|092|B|||
1431|093|A|Information last revised December 2024.||
1431|094|A|Copyright(c) 2025 First Databank, Inc.||
1431|095|B|||
1432|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1432|002|Z|does NOT have all possible information about this product. This||
1432|003|Z|information does not assure that this product is safe, effective,||
1432|004|Z|or appropriate for you. This information is not individual||
1432|005|Z|medical advice and does not substitute for the advice of your||
1432|006|Z|health care professional. Always ask your health care||
1432|007|Z|professional for complete information about this product and your||
1432|008|Z|specific health needs.||
1432|009|B|||
1432|010|T|EMTRICITABINE/RILPIVIRINE/TENOFOVIR - ORAL||
1432|011|F|(EM-trye-SYE-ta-been/RIL-pi-VIR-een/ten-OF-oh-vir)||
1432|012|B|||
1432|013|C|COMMON BRAND NAME(S): Complera||
1432|014|B|||
1432|015|W|WARNING:  If you have hepatitis B infection, your hepatitis||
1432|016|W|symptoms may get worse or become very serious if you stop taking||
1432|017|W|this medication. Talk with your doctor before stopping this||
1432|018|W|medication. Your doctor will monitor liver tests for several||
1432|019|W|months after you stop emtricitabine/rilpivirine/tenofovir. Tell||
1432|020|W|your doctor right away if you have symptoms of worsening liver||
1432|021|W|problems.||
1432|022|B|||
1432|023|U|USES:  This product contains 3 different medications:||
1432|024|U|emtricitabine, rilpivirine, and tenofovir. It is used to help||
1432|025|U|control HIV infection. It helps to decrease the amount of HIV in||
1432|026|U|your body so your immune system can work better. This lowers your||
1432|027|U|chance of getting HIV complications (such as new infections,||
1432|028|U|cancer) and improves your quality of life. Emtricitabine and||
1432|029|U|tenofovir belong to a class of drugs known as nucleoside reverse||
1432|030|U|transcriptase inhibitors (NRTIs). Rilpivirine belongs to a class||
1432|031|U|of drugs known as non-nucleoside reverse transcriptase inhibitors||
1432|032|U|(NNRTIs).||
1432|033|U|   Emtricitabine/rilpivirine/tenofovir is not a cure for HIV||
1432|034|U|infection. To decrease your risk of spreading HIV disease to||
1432|035|U|others, continue to take all HIV medications exactly as||
1432|036|U|prescribed by your doctor. Use an effective barrier method (latex||
1432|037|U|or polyurethane condoms/dental dams) during sexual activity as||
1432|038|U|directed by your doctor. Do not share personal items (such as||
1432|039|U|needles/syringes, toothbrushes, and razors) that may have||
1432|040|U|contacted blood or other body fluids. Consult your doctor or||
1432|041|U|pharmacist for more details.||
1432|042|B|||
1432|043|V|OTHER USES:  This section contains uses of this drug that are not||
1432|044|V|listed in the approved professional labeling for the drug but||
1432|045|V|that may be prescribed by your health care professional. Use this||
1432|046|V|drug for a condition that is listed in this section only if it||
1432|047|V|has been so prescribed by your health care professional.||
1432|048|V|   This product may also be used to lessen the risk of HIV||
1432|049|V|infection after contact with the virus (for example, due to a||
1432|050|V|needle stick). Ask your doctor for more details.||
1432|051|B|||
1432|052|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1432|053|H|from your pharmacist before you start taking this medication and||
1432|054|H|each time you get a refill. If you have any questions, ask your||
1432|055|H|doctor or pharmacist.||
1432|056|H|   Take this medication by mouth with food as directed by your||
1432|057|H|doctor, usually once daily.||
1432|058|H|   Medications that reduce stomach acid (such as antacids, proton||
1432|059|H|pump inhibitors/PPIs, H2 blockers) may make rilpivirine work less||
1432|060|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
1432|061|H|using this medication. If you take antacids, take the antacids at||
1432|062|H|least 2 hours before or at least 4 hours after this medication.||
1432|063|H|If you take H2 blockers (such as famotidine, nizatidine), take||
1432|064|H|them at least 12 hours before or at least 4 hours after this||
1432|065|H|medication.||
1432|066|H|   It is very important to keep taking this medication exactly as||
1432|067|H|prescribed by your doctor. Do not take less of this drug than||
1432|068|H|prescribed or stop taking it even for a short time unless||
1432|069|H|directed to do so by your doctor. Doing so may cause the amount||
1432|070|H|of virus to increase and/or make the infection more difficult to||
1432|071|H|treat (resistant).||
1432|072|H|   Do not increase your dose or take this medication more often||
1432|073|H|than prescribed. Your condition will not improve any faster, and||
1432|074|H|your risk of side effects may increase.||
1432|075|H|   For the best effect, take this medication at evenly spaced||
1432|076|H|times. To help you remember, take this medication at the same||
1432|077|H|time every day.||
1432|078|B|||
1432|079|S|SIDE EFFECTS:  Headache, trouble sleeping, diarrhea, tiredness,||
1432|080|S|dizziness, and skin discoloration (such as small spots/freckles,||
1432|081|S|darkening of the palms of the hands/soles of the feet) may occur.||
1432|082|S|If any of these effects last or get worse, tell your doctor or||
1432|083|S|pharmacist promptly.||
1432|084|S|   Remember that this medication has been prescribed because your||
1432|085|S|doctor has judged that the benefit to you is greater than the||
1432|086|S|risk of side effects. Many people using this medication do not||
1432|087|S|have serious side effects.||
1432|088|S|   As your immune system gets stronger, it can begin to fight off||
1432|089|S|infections you already had, possibly causing disease symptoms to||
1432|090|S|come back. You could also have symptoms if your immune system||
1432|091|S|becomes overactive. This reaction may happen at any time (soon||
1432|092|S|after starting HIV treatment or many months later). Tell your||
1432|093|S|doctor right away if you have any serious symptoms, including:||
1432|094|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1432|095|S|that doesn't go away, headaches that are severe or don't go away,||
1432|096|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1432|097|S|changes, signs of infection (such as sore throat that doesn't go||
1432|098|S|away, fever, chills, non-healing skin sores), signs of an||
1432|099|S|overactive thyroid (such as irritability, nervousness, heat||
1432|100|S|intolerance, fast/pounding/irregular heartbeat), signs of liver||
1432|101|S|disease (such as nausea/vomiting that doesn't stop, loss of||
1432|102|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1432|103|S|urine).||
1432|104|S|   Tell your doctor right away if you have any serious side||
1432|105|S|effects, including: signs of kidney problems (such as change in||
1432|106|S|the amount of urine, pink/bloody urine), mental/mood changes||
1432|107|S|(such as depression, thoughts of suicide).||
1432|108|S|   Rarely, this medication can cause a severe (sometimes fatal)||
1432|109|S|blood problem (lactic acidosis). Tell your doctor right away if||
1432|110|S|you develop symptoms of lactic acidosis (such as deep/rapid||
1432|111|S|breathing, drowsiness, nausea/vomiting, unusual weakness).||
1432|112|S|   Tenofovir may increase the risk of bone loss. Discuss the||
1432|113|S|risks and benefits of treatment with your doctor, as well as the||
1432|114|S|possible use of calcium and vitamin D to reduce this side effect.||
1432|115|S|If you are at risk for bone loss, your doctor may monitor your||
1432|116|S|bone mineral density. Tell your doctor right away if any of the||
1432|117|S|following serious side effects occur: bone pain, easily broken||
1432|118|S|bones.||
1432|119|S|   This medication can commonly cause a rash that is usually not||
1432|120|S|serious. However, you may not be able to tell it apart from a||
1432|121|S|rare rash that could be a sign of a severe reaction. Get medical||
1432|122|S|help right away if you develop any rash.||
1432|123|S|   A very serious allergic reaction to this drug is rare.||
1432|124|S|However, get medical help right away if you notice any symptoms||
1432|125|S|of a serious allergic reaction, including: swollen lymph nodes,||
1432|126|S|rash, itching/swelling (especially of the face/tongue/throat),||
1432|127|S|severe dizziness, trouble breathing.||
1432|128|S|   This is not a complete list of possible side effects. If you||
1432|129|S|notice other effects not listed above, contact your doctor or||
1432|130|S|pharmacist.||
1432|131|S|   In the US -||
1432|132|S|   Call your doctor for medical advice about side effects. You||
1432|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1432|134|S|www.fda.gov/medwatch.||
1432|135|S|   In Canada - Call your doctor for medical advice about side||
1432|136|S|effects. You may report side effects to Health Canada at||
1432|137|S|1-866-234-2345.||
1432|138|B|||
1432|139|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1432|140|P|pharmacist if you are allergic to emtricitabine, rilpivirine, or||
1432|141|P|tenofovir; or if you have any other allergies. This product may||
1432|142|P|contain inactive ingredients, which can cause allergic reactions||
1432|143|P|or other problems. Talk to your pharmacist for more details.||
1432|144|P|   Before using this medication, tell your doctor or pharmacist||
1432|145|P|your medical history, especially of: kidney disease, liver||
1432|146|P|disease (such as hepatitis B or C, cirrhosis), alcohol use, bone||
1432|147|P|problems (such as bone disease, bone loss/osteoporosis,||
1432|148|P|weak/broken bones), mental/mood disorders (such as depression).||
1432|149|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1432|150|P|can make you more dizzy. Do not drive, use machinery, or do||
1432|151|P|anything that needs alertness until you can do it safely. Limit||
1432|152|P|alcoholic beverages. Talk to your doctor if you are using||
1432|153|P|marijuana (cannabis).||
1432|154|P|   Before having surgery, tell your doctor or dentist about all||
1432|155|P|the products you use (including prescription drugs,||
1432|156|P|nonprescription drugs, and herbal products).||
1432|157|P|   During pregnancy, this medication should be used only when||
1432|158|P|clearly needed. Treatment can lower the risk of passing HIV||
1432|159|P|infection to your baby, and this medication may be part of that||
1432|160|P|treatment. Discuss the risks and benefits with your doctor.||
1432|161|P|   This medication passes into breast milk. Because breast milk||
1432|162|P|may transmit HIV, consult your doctor before breastfeeding.||
1432|163|B|||
1432|164|I|DRUG INTERACTIONS:  See also How to Use section.||
1432|165|I|   Drug interactions may change how your medications work or||
1432|166|I|increase your risk for serious side effects. This document does||
1432|167|I|not contain all possible drug interactions. Keep a list of all||
1432|168|I|the products you use (including prescription/nonprescription||
1432|169|I|drugs and herbal products) and share it with your doctor and||
1432|170|I|pharmacist. Do not start, stop, or change the dosage of any||
1432|171|I|medicines without your doctor's approval.||
1432|172|I|   Some products that may interact with this drug include:||
1432|173|I|adefovir, orlistat, other drugs that may be harmful to the||
1432|174|I|kidneys (including aminoglycosides such as amikacin/gentamicin),||
1432|175|I|proton pump inhibitors (PPIs such as dexlansoprazole,||
1432|176|I|esomeprazole, lansoprazole, omeprazole, pantoprazole,||
1432|177|I|rabeprazole).||
1432|178|I|   Do not take this medication with other products that treat HIV||
1432|179|I|infection, especially products that contain didanosine,||
1432|180|I|emtricitabine, tenofovir, or lamivudine. In addition, do not take||
1432|181|I|this medication with other products that contain rilpivirine,||
1432|182|I|unless you are also taking rifabutin.||
1432|183|I|   Other medications can affect the removal of rilpivirine from||
1432|184|I|your body, which may affect how this medication works. Examples||
1432|185|I|include dexamethasone, macrolide antibiotics (such as||
1432|186|I|erythromycin), rifamycins (such as rifampin, rifapentine), St.||
1432|187|I|John's wort, certain drugs used to treat seizures (such as||
1432|188|I|carbamazepine, oxcarbazepine, phenobarbital, phenytoin,||
1432|189|I|primidone), telithromycin, among others.||
1432|190|B|||
1432|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1432|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1432|193|O|poison control center right away. US residents can call||
1432|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1432|195|O|Symptoms of overdose may include: fast/irregular heartbeat,||
1432|196|O|severe dizziness, fainting.||
1432|197|B|||
1432|198|N|NOTES:  Do not share this medication with others.||
1432|199|N|   Lab and/or medical tests (such as kidney/liver function, urine||
1432|200|N|glucose/protein, viral load, test for hepatitis B virus, T-cell||
1432|201|N|counts, blood mineral levels, bone density tests) should be done||
1432|202|N|before you start taking this medication and while you are taking||
1432|203|N|it. Keep all medical and lab appointments.||
1432|204|B|||
1432|205|D|MISSED DOSE:  If you miss a dose, take it with food as soon as||
1432|206|D|you remember. If it is more than 12 hours after the missed dose,||
1432|207|D|skip the missed dose. Take your next dose at the regular time. Do||
1432|208|D|not double the dose to catch up.||
1432|209|B|||
1432|210|R|STORAGE:  Store in the original bottle at room temperature away||
1432|211|R|from light and moisture. Do not store in the bathroom. Keep all||
1432|212|R|medications away from children and pets.||
1432|213|R|   Do not flush medications down the toilet or pour them into a||
1432|214|R|drain unless instructed to do so. Properly discard this product||
1432|215|R|when it is expired or no longer needed. Consult your pharmacist||
1432|216|R|or local waste disposal company.||
1432|217|B|||
1432|218|A|Information last revised June 2025.||
1432|219|A|Copyright(c) 2025 First Databank, Inc.||
1432|220|B|||
1433|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1433|002|Z|does NOT have all possible information about this product. This||
1433|003|Z|information does not assure that this product is safe, effective,||
1433|004|Z|or appropriate for you. This information is not individual||
1433|005|Z|medical advice and does not substitute for the advice of your||
1433|006|Z|health care professional. Always ask your health care||
1433|007|Z|professional for complete information about this product and your||
1433|008|Z|specific health needs.||
1433|009|B|||
1433|010|T|ABATACEPT - SUBCUTANEOUS INJECTION||
1433|011|F|(a-BAT-a-sept)||
1433|012|B|||
1433|013|C|COMMON BRAND NAME(S): Orencia||
1433|014|B|||
1433|015|U|USES:  This medication is used to treat rheumatoid arthritis, a||
1433|016|U|condition in which the body's own defense system (immune system)||
1433|017|U|attacks healthy tissue. This leads to swelling in the joints,||
1433|018|U|which causes pain and makes it harder to move. Abatacept works by||
1433|019|U|weakening your immune system. This effect helps to slow down||
1433|020|U|joint damage and reduce joint pain and swelling so you can move||
1433|021|U|better. This medication is also used to treat other types of||
1433|022|U|arthritis (such as juvenile idiopathic arthritis, psoriatic||
1433|023|U|arthritis).||
1433|024|B|||
1433|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
1433|026|H|Instructions for Use if available from your pharmacist before you||
1433|027|H|start using this medication and each time you get a refill. Ask||
1433|028|H|your health care professional how to prepare and use this||
1433|029|H|medication. If you have any questions, ask your doctor or||
1433|030|H|pharmacist.||
1433|031|H|   Inject this medication under the skin as directed by your||
1433|032|H|doctor, usually once a week. The injection is given in the thigh,||
1433|033|H|abdomen, or upper arm. Your doctor may direct you to first||
1433|034|H|receive abatacept by injection into a vein (loading dose) before||
1433|035|H|starting treatment with this form of the medication. If you are||
1433|036|H|switching from regularly scheduled injections into a vein,||
1433|037|H|carefully follow your doctor's directions for when to start using||
1433|038|H|this medication (usually instead of the next scheduled dose). The||
1433|039|H|dosage is based on your medical condition and response to||
1433|040|H|treatment. Children's dosage is also based on weight.||
1433|041|H|   Take the medication out of the refrigerator 30 to 60 minutes||
1433|042|H|before you inject it to allow it to reach room temperature. Do||
1433|043|H|not warm up this medication any other way (for example, do not||
1433|044|H|heat it in the microwave or place it in hot water). Before using,||
1433|045|H|check this product for particles or discoloration. If either is||
1433|046|H|present, do not use the liquid. Before injecting each dose, clean||
1433|047|H|the skin you are going to inject into (the injection site) with||
1433|048|H|rubbing alcohol. Change the injection site each time to lessen||
1433|049|H|injury under the skin. Do not inject into skin that is sore,||
1433|050|H|bruised, red, scaly, or hard. To lessen bruising, do not rub the||
1433|051|H|injection site after a shot. Learn how to store and discard||
1433|052|H|medical supplies safely.||
1433|053|H|   Use this medication regularly to get the most benefit from it.||
1433|054|H|To help you remember, mark your calendar with a reminder.||
1433|055|H|   Tell your doctor if your symptoms do not get better or if they||
1433|056|H|get worse.||
1433|057|B|||
1433|058|S|SIDE EFFECTS:  Headache, nausea, or cold symptoms such as stuffy||
1433|059|S|head/nose may occur. Pain, irritation, or swelling at/near the||
1433|060|S|injection site may also occur. If any of these effects last or||
1433|061|S|get worse, tell your doctor or pharmacist promptly.||
1433|062|S|   Remember that this medication has been prescribed because your||
1433|063|S|doctor has judged that the benefit to you is greater than the||
1433|064|S|risk of side effects. Many people using this medication do not||
1433|065|S|have serious side effects.||
1433|066|S|   Because abatacept works by weakening the immune system, it may||
1433|067|S|lower your ability to fight infections. This may make you more||
1433|068|S|likely to get a serious (rarely fatal) infection or make any||
1433|069|S|infection you have worse. Tell your doctor right away if you have||
1433|070|S|any signs of infection (such as sore throat that doesn't go away,||
1433|071|S|fever, chills).||
1433|072|S|   Rarely, patients using abatacept have developed cancer (such||
1433|073|S|as lymphoma, lung/skin cancer). Tell your doctor right away if||
1433|074|S|you develop symptoms such as unusual lumps/growths/skin changes,||
1433|075|S|swollen lymph nodes, night sweats, unexplained weight loss,||
1433|076|S|shortness of breath, wheezing.||
1433|077|S|   A very serious allergic reaction to this drug is rare.||
1433|078|S|However, get medical help right away if you notice any symptoms||
1433|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1433|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1433|081|S|breathing.||
1433|082|S|   This is not a complete list of possible side effects. If you||
1433|083|S|notice other effects not listed above, contact your doctor or||
1433|084|S|pharmacist.||
1433|085|S|   In the US -||
1433|086|S|   Call your doctor for medical advice about side effects. You||
1433|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1433|088|S|www.fda.gov/medwatch.||
1433|089|S|   In Canada - Call your doctor for medical advice about side||
1433|090|S|effects. You may report side effects to Health Canada at||
1433|091|S|1-866-234-2345.||
1433|092|B|||
1433|093|P|PRECAUTIONS:  Before using abatacept, tell your doctor or||
1433|094|P|pharmacist if you are allergic to it; or if you have any other||
1433|095|P|allergies. This product may contain inactive ingredients, which||
1433|096|P|can cause allergic reactions or other problems. Talk to your||
1433|097|P|pharmacist for more details.||
1433|098|P|   Before using this medication, tell your doctor or pharmacist||
1433|099|P|your medical history, especially of: cancer, chronic obstructive||
1433|100|P|pulmonary disease-COPD, current/recent/returning infection (such||
1433|101|P|as tuberculosis, hepatitis), immune system disorder (such as HIV||
1433|102|P|infection, bone marrow disorder).||
1433|103|P|   Abatacept can make you more likely to get infections or may||
1433|104|P|make current infections worse. Stay away from anyone who has an||
1433|105|P|infection that may easily spread (such as chickenpox, COVID-19,||
1433|106|P|measles, flu). Talk to your doctor if you have been exposed to an||
1433|107|P|infection or for more details.||
1433|108|P|   Tell your health care professional that you are using||
1433|109|P|abatacept before having any immunizations/vaccinations. Certain||
1433|110|P|types of vaccines (live vaccines) should not be given during or||
1433|111|P|within 3 months after the last dose of this medication. Avoid||
1433|112|P|contact with people who have recently received live vaccines||
1433|113|P|(such as flu vaccine inhaled through the nose).||
1433|114|P|   Children using this medication should have all recommended||
1433|115|P|vaccinations before starting treatment with abatacept. Ask the||
1433|116|P|child's doctor for details.||
1433|117|P|   Before having surgery, tell your doctor or dentist about all||
1433|118|P|the products you use (including prescription drugs,||
1433|119|P|nonprescription drugs, and herbal products).||
1433|120|P|   During pregnancy, this medication should be used only when||
1433|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
1433|122|P|   It is unknown if this medication passes into breast milk.||
1433|123|P|Consult your doctor before breastfeeding.||
1433|124|B|||
1433|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1433|126|I|medications work or increase your risk for serious side effects.||
1433|127|I|This document does not contain all possible drug interactions.||
1433|128|I|Keep a list of all the products you use (including||
1433|129|I|prescription/nonprescription drugs and herbal products) and share||
1433|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
1433|131|I|the dosage of any medicines without your doctor's approval.||
1433|132|I|   Some products that may interact with this drug include:||
1433|133|I|anakinra, rituximab, TNF blocking agents (such as adalimumab,||
1433|134|I|etanercept, infliximab).||
1433|135|B|||
1433|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1433|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1433|138|O|poison control center right away. US residents can call||
1433|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1433|140|B|||
1433|141|N|NOTES:  Do not share this medication with others.||
1433|142|N|   Lab and/or medical tests (such as tuberculosis skin test, test||
1433|143|N|for hepatitis B virus, skin exams) should be done before you||
1433|144|N|start taking this medication and while you are taking it. Keep||
1433|145|N|all medical and lab appointments. Consult your doctor for more||
1433|146|N|details.||
1433|147|B|||
1433|148|D|MISSED DOSE:  It is important to get each dose of this medication||
1433|149|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1433|150|D|right away for a new dosing schedule. Do not double the dose to||
1433|151|D|catch up.||
1433|152|B|||
1433|153|R|STORAGE:  Store in the refrigerator away from light. Do not||
1433|154|R|freeze. Keep all medications away from children and pets.||
1433|155|R|   Do not flush medications down the toilet or pour them into a||
1433|156|R|drain unless instructed to do so. Properly discard this product||
1433|157|R|when it is expired or no longer needed. Consult your pharmacist||
1433|158|R|or local waste disposal company.||
1433|159|B|||
1433|160|M|MEDICAL ALERT:  Your condition can cause complications in a||
1433|161|M|medical emergency. For information about enrolling in MedicAlert,||
1433|162|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1433|163|B|||
1433|164|A|Information last revised May 2025.||
1433|165|A|Copyright(c) 2025 First Databank, Inc.||
1433|166|B|||
1434|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1434|002|Z|does NOT have all possible information about this product. This||
1434|003|Z|information does not assure that this product is safe, effective,||
1434|004|Z|or appropriate for you. This information is not individual||
1434|005|Z|medical advice and does not substitute for the advice of your||
1434|006|Z|health care professional. Always ask your health care||
1434|007|Z|professional for complete information about this product and your||
1434|008|Z|specific health needs.||
1434|009|B|||
1434|010|T|ZOLPIDEM (1.75 OR 3.5 MG) - SUBLINGUAL||
1434|011|F|(ZOL-pi-dem)||
1434|012|B|||
1434|013|C|COMMON BRAND NAME(S): Intermezzo||
1434|014|B|||
1434|015|W|WARNING:  Rarely, after taking this drug, people have gotten out||
1434|016|W|of bed and driven vehicles while not fully awake||
1434|017|W|("sleep-driving"). People have also sleepwalked, prepared/eaten||
1434|018|W|food, made phone calls, or had sex while not fully awake. Often,||
1434|019|W|these people do not remember these events. This problem can be||
1434|020|W|dangerous (possibly fatal) to you or to others. If you find out||
1434|021|W|that you have done any of these activities after taking this||
1434|022|W|medication, tell your doctor right away. You should not take this||
1434|023|W|medication or similar medications (such as eszopiclone, zaleplon)||
1434|024|W|if you have this reaction to the medication.||
1434|025|B|||
1434|026|U|USES:  This medication is used for a short time to treat a||
1434|027|U|certain type of sleep problem (insomnia) in adults who have||
1434|028|U|trouble falling back asleep after waking up in the middle of the||
1434|029|U|night. It helps you return to sleep faster so you can get a||
1434|030|U|better night's rest. Zolpidem belongs to a class of drugs called||
1434|031|U|sedative-hypnotics. It acts on your brain to produce a calming||
1434|032|U|effect.||
1434|033|U|   This medication should only be taken if you have at least 4||
1434|034|U|hours of bedtime left.||
1434|035|B|||
1434|036|H|HOW TO USE:  Read the Medication Guide and the Instructions for||
1434|037|H|Use provided by your pharmacist before you start taking zolpidem||
1434|038|H|and each time you get a refill. If you have any questions, ask||
1434|039|H|your doctor or pharmacist.||
1434|040|H|   If you wake up in the middle of the night and have trouble||
1434|041|H|falling asleep again, take this medication as directed by your||
1434|042|H|doctor, usually only once a night if needed. Only take it if you||
1434|043|H|have at least 4 hours of bedtime left, otherwise you may still be||
1434|044|H|drowsy in the morning.||
1434|045|H|   Do not take this medication with alcohol, or if you have had||
1434|046|H|alcohol that day, especially in the evening or before bed. Also||
1434|047|H|do not take this medication with other drugs to help you sleep.||
1434|048|H|   Do not remove the medication from the pouch until you are||
1434|049|H|ready to take it. Since zolpidem works quickly, take it while you||
1434|050|H|are in bed. It is best to take it on an empty stomach. Do not||
1434|051|H|take zolpidem with or after a meal because it will not work as||
1434|052|H|quickly. Place the tablet under your tongue and let it break||
1434|053|H|apart completely before swallowing. Do not swallow the tablet||
1434|054|H|whole.||
1434|055|H|   The dosage is based on your gender, age, medical condition,||
1434|056|H|response to treatment, and other medications you may be taking.||
1434|057|H|Women are usually prescribed a lower dose because it is removed||
1434|058|H|from the body more slowly than in men. Older adults are usually||
1434|059|H|prescribed a lower dose to decrease the risk of side effects. Do||
1434|060|H|not increase your dose, take it more often, or use it for longer||
1434|061|H|than prescribed. Be sure to tell your doctor and pharmacist about||
1434|062|H|all the products you use (including prescription drugs,||
1434|063|H|nonprescription drugs, and herbal products).||
1434|064|H|   If you suddenly stop using this medication, you may have||
1434|065|H|withdrawal symptoms (such as nausea, vomiting, flushing, stomach||
1434|066|H|cramps, nervousness, shakiness). To help prevent withdrawal, your||
1434|067|H|doctor may lower your dose slowly. Withdrawal is more likely if||
1434|068|H|you have used zolpidem for a long time or in high doses. Tell||
1434|069|H|your doctor or pharmacist right away if you have withdrawal.||
1434|070|H|   When this medication is used for a long time, it may not work||
1434|071|H|as well. Talk with your doctor if this medication stops working||
1434|072|H|well.||
1434|073|H|   Though it helps many people, this medication may sometimes||
1434|074|H|cause addiction. This risk may be higher if you have a substance||
1434|075|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1434|076|H|Take this medication exactly as prescribed to lower the risk of||
1434|077|H|addiction. Ask your doctor or pharmacist for more details.||
1434|078|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
1434|079|H|or if it gets worse.||
1434|080|H|   You may have trouble sleeping the first few nights after you||
1434|081|H|stop taking this medication. This is called rebound insomnia and||
1434|082|H|is normal. It will usually go away after 1-2 nights. If this||
1434|083|H|effect continues, contact your doctor.||
1434|084|B|||
1434|085|S|SIDE EFFECTS:  See also Warning section.||
1434|086|S|   Dizziness may occur. If this effect lasts or gets worse, tell||
1434|087|S|your doctor or pharmacist promptly.||
1434|088|S|   This medication may make you sleepy during the day, especially||
1434|089|S|if you do not take it as instructed (see the How to Use section).||
1434|090|S|Tell your doctor or pharmacist if you have daytime drowsiness.||
1434|091|S|Your dose may need to be adjusted.||
1434|092|S|   Remember that this medication has been prescribed because your||
1434|093|S|doctor has judged that the benefit to you is greater than the||
1434|094|S|risk of side effects. Many people using this medication do not||
1434|095|S|have serious side effects.||
1434|096|S|   Tell your doctor right away if you have any serious side||
1434|097|S|effects, including: memory loss, mental/mood/behavior changes||
1434|098|S|(such as new/worsening depression, abnormal thoughts, thoughts of||
1434|099|S|suicide, hallucinations, confusion, agitation, aggressive||
1434|100|S|behavior, anxiety).||
1434|101|S|   A very serious allergic reaction to this drug is rare.||
1434|102|S|However, get medical help right away if you notice any symptoms||
1434|103|S|of a serious allergic reaction, including: rash, itching/swelling||
1434|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1434|105|S|breathing.||
1434|106|S|   This is not a complete list of possible side effects. If you||
1434|107|S|notice other effects not listed above, contact your doctor or||
1434|108|S|pharmacist.||
1434|109|S|   In the US -||
1434|110|S|   Call your doctor for medical advice about side effects. You||
1434|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1434|112|S|www.fda.gov/medwatch.||
1434|113|S|   In Canada - Call your doctor for medical advice about side||
1434|114|S|effects. You may report side effects to Health Canada at||
1434|115|S|1-866-234-2345.||
1434|116|B|||
1434|117|P|PRECAUTIONS:  See also Warning section.||
1434|118|P|   Before taking zolpidem, tell your doctor or pharmacist if you||
1434|119|P|are allergic to it; or if you have any other allergies. This||
1434|120|P|product may contain inactive ingredients, which can cause||
1434|121|P|allergic reactions or other problems. Talk to your pharmacist for||
1434|122|P|more details.||
1434|123|P|   Before using this medication, tell your doctor or pharmacist||
1434|124|P|your medical history, especially of: liver disease, mental/mood||
1434|125|P|problems (such as depression, thoughts of suicide), personal or||
1434|126|P|family history of a substance use disorder (such as overuse of or||
1434|127|P|addiction to drugs/alcohol), personal or family history of||
1434|128|P|sleepwalking, lung/breathing problems (such as chronic||
1434|129|P|obstructive pulmonary disease-COPD, sleep apnea), a certain||
1434|130|P|muscle disease (myasthenia gravis).||
1434|131|P|   Since this drug makes you drowsy, wait at least 4 hours after||
1434|132|P|taking a dose and until you feel completely awake before doing||
1434|133|P|any activity. This medication may increase the risk of falls. You||
1434|134|P|may also experience dizziness or blurred/double vision. Alcohol||
1434|135|P|or marijuana (cannabis) can make you more dizzy or drowsy. Do not||
1434|136|P|drive, use machinery, or do anything that needs alertness until||
1434|137|P|you can do it safely. Avoid alcoholic beverages. Talk to your||
1434|138|P|doctor if you are using marijuana (cannabis).||
1434|139|P|   Before having surgery, tell your doctor or dentist about all||
1434|140|P|the products you use (including prescription drugs,||
1434|141|P|nonprescription drugs, and herbal products).||
1434|142|P|   Children may be more sensitive to the side effects of this||
1434|143|P|drug, especially dizziness and hallucinations.||
1434|144|P|   Older adults may be more sensitive to the side effects of this||
1434|145|P|drug, especially dizziness, confusion, unsteadiness, and||
1434|146|P|excessive drowsiness. These side effects can increase the risk of||
1434|147|P|falling.||
1434|148|P|   During pregnancy, this medication should be used only when||
1434|149|P|clearly needed. Babies born to mothers who have used this drug||
1434|150|P|late in the last 3 months of pregnancy may develop unusual||
1434|151|P|sleepiness, trouble breathing, unusual limpness, or withdrawal||
1434|152|P|symptoms. Get medical help right away if you notice any unusual||
1434|153|P|symptoms in your newborn. Discuss the risks and benefits with||
1434|154|P|your doctor.||
1434|155|P|   A small amount of this medication passes into breast milk and||
1434|156|P|may have undesirable effects on a nursing infant (such as unusual||
1434|157|P|sleepiness, trouble breathing, or unusual limpness). Get medical||
1434|158|P|help right away if you notice any unusual symptoms in your baby.||
1434|159|P|Ask your doctor if you should pump and discard your breast milk||
1434|160|P|during treatment and for 23 hours after a dose of this medication||
1434|161|P|to lessen the risk of these effects in your baby. Consult your||
1434|162|P|doctor before breastfeeding.||
1434|163|B|||
1434|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1434|165|I|medications work or increase your risk for serious side effects.||
1434|166|I|This document does not contain all possible drug interactions.||
1434|167|I|Keep a list of all the products you use (including||
1434|168|I|prescription/nonprescription drugs and herbal products) and share||
1434|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
1434|170|I|the dosage of any medicines without your doctor's approval.||
1434|171|I|   A product that may interact with this drug is: sodium oxybate.||
1434|172|I|   Other medications can affect the removal of zolpidem from your||
1434|173|I|body, which may affect how zolpidem works. Examples include azole||
1434|174|I|antifungals (such as ketoconazole), rifampin, St. John's Wort,||
1434|175|I|among others.||
1434|176|I|   The risk of serious side effects (such as slow/shallow||
1434|177|I|breathing, severe drowsiness/dizziness) may be increased if this||
1434|178|I|medication is taken with other products that may also cause||
1434|179|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1434|180|I|if you are taking other products such as opioid pain or cough||
1434|181|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1434|182|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
1434|183|I|lorazepam, zopiclone), muscle relaxants (such as carisoprodol,||
1434|184|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1434|185|I|diphenhydramine).||
1434|186|I|   Check the labels on all your medicines (such as allergy or||
1434|187|I|cough-and-cold products) because they may contain ingredients||
1434|188|I|that cause drowsiness. Ask your pharmacist about using those||
1434|189|I|products safely.||
1434|190|B|||
1434|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1434|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1434|193|O|poison control center right away. US residents can call||
1434|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1434|195|O|Symptoms of overdose may include: slowed breathing or a deep||
1434|196|O|sleep from which you cannot be awakened.||
1434|197|B|||
1434|198|N|NOTES:  Do not share this medication with others. Sharing it is||
1434|199|N|against the law.||
1434|200|N|   As you get older, your sleep pattern may naturally change and||
1434|201|N|your sleep may be interrupted several times during the night.||
1434|202|N|Consult your doctor or pharmacist for ways to improve your sleep||
1434|203|N|without medication, such as avoiding caffeine and alcohol close||
1434|204|N|to bedtime, avoiding daytime naps, and going to bed at the same||
1434|205|N|time each night.||
1434|206|B|||
1434|207|D|MISSED DOSE:  Not applicable.||
1434|208|B|||
1434|209|R|STORAGE:  Store at room temperature away from light and moisture.||
1434|210|R|Do not store in the bathroom. Keep all medications away from||
1434|211|R|children and pets.||
1434|212|R|   Do not flush medications down the toilet or pour them into a||
1434|213|R|drain unless instructed to do so. Properly discard this product||
1434|214|R|when it is expired or no longer needed. Consult your pharmacist||
1434|215|R|or local waste disposal company.||
1434|216|B|||
1434|217|A|Information last revised May 2024.||
1434|218|A|Copyright(c) 2025 First Databank, Inc.||
1434|219|B|||
1435|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1435|002|Z|does NOT have all possible information about this product. This||
1435|003|Z|information does not assure that this product is safe, effective,||
1435|004|Z|or appropriate for you. This information is not individual||
1435|005|Z|medical advice and does not substitute for the advice of your||
1435|006|Z|health care professional. Always ask your health care||
1435|007|Z|professional for complete information about this product and your||
1435|008|Z|specific health needs.||
1435|009|B|||
1435|010|T|ICATIBANT - INJECTION||
1435|011|F|(eye-KAT-i-bant)||
1435|012|B|||
1435|013|C|COMMON BRAND NAME(S): Firazyr||
1435|014|B|||
1435|015|U|USES:  Icatibant is used to treat sudden attacks of a certain||
1435|016|U|immune system condition passed down through families called||
1435|017|U|hereditary angioedema (HAE). Although this medication is not a||
1435|018|U|cure for HAE, icatibant may lessen the symptoms of an attack such||
1435|019|U|as rapid swelling and pain of the hands, arms, feet, legs, face,||
1435|020|U|tongue, and upper airway. When attacks involve the||
1435|021|U|stomach/intestines, symptoms may include abdominal pain/cramps,||
1435|022|U|diarrhea, constipation, or vomiting. Attacks may happen at any||
1435|023|U|time. However, stress, injury, or illness may trigger attacks in||
1435|024|U|some people.||
1435|025|U|   Icatibant works by blocking the action of a natural substance||
1435|026|U|in the body called bradykinin. Bradykinin is thought to cause the||
1435|027|U|symptoms of an HAE attack.||
1435|028|B|||
1435|029|H|HOW TO USE:  Read the Patient Information Leaflet and||
1435|030|H|Instructions for Use if available from your pharmacist before you||
1435|031|H|start using icatibant and each time you get a refill. Ask your||
1435|032|H|health care professional how to prepare and use this medication.||
1435|033|H|If you have any questions, ask your doctor or pharmacist.||
1435|034|H|   Inject this medication under the skin as directed by your||
1435|035|H|doctor, usually over at least 30 seconds. The injection is given||
1435|036|H|in the stomach/abdominal area. If your symptoms continue or come||
1435|037|H|back, you may give another dose after at least 6 hours. Do not||
1435|038|H|use more than 3 doses in 24 hours.||
1435|039|H|   Before using, check this product for particles or||
1435|040|H|discoloration. If either is present, do not use the liquid.||
1435|041|H|Before injecting each dose, clean the skin you are going to||
1435|042|H|inject into (the injection site) with rubbing alcohol. Change the||
1435|043|H|injection site each time to lessen injury under the skin. Learn||
1435|044|H|how to store and discard medical supplies safely.||
1435|045|H|   If you have a sudden HAE attack of your throat area/voice||
1435|046|H|box/upper airway (larynx), give yourself an injection of||
1435|047|H|icatibant and then get medical help right away. This type of||
1435|048|H|attack may lead to a blocked airway and serious breathing||
1435|049|H|trouble.||
1435|050|H|   Tell your doctor if your symptoms do not get better or if they||
1435|051|H|get worse.||
1435|052|B|||
1435|053|S|SIDE EFFECTS:  Fever or dizziness may occur. Injection site||
1435|054|S|reactions (such as redness, burning, swelling, bruising,||
1435|055|S|irritation, pain) may also occur. If any of these effects last or||
1435|056|S|get worse, tell your doctor or pharmacist promptly.||
1435|057|S|   Remember that this medication has been prescribed because your||
1435|058|S|doctor has judged that the benefit to you is greater than the||
1435|059|S|risk of side effects. Many people using this medication do not||
1435|060|S|have serious side effects.||
1435|061|S|   A very serious allergic reaction to this drug is rare.||
1435|062|S|However, get medical help right away if you notice any symptoms||
1435|063|S|of a serious allergic reaction, including: rash, itching/swelling||
1435|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1435|065|S|breathing.||
1435|066|S|   This is not a complete list of possible side effects. If you||
1435|067|S|notice other effects not listed above, contact your doctor or||
1435|068|S|pharmacist.||
1435|069|S|   In the US -||
1435|070|S|   Call your doctor for medical advice about side effects. You||
1435|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1435|072|S|www.fda.gov/medwatch.||
1435|073|S|   In Canada - Call your doctor for medical advice about side||
1435|074|S|effects. You may report side effects to Health Canada at||
1435|075|S|1-866-234-2345.||
1435|076|B|||
1435|077|P|PRECAUTIONS:  Before using icatibant, tell your doctor or||
1435|078|P|pharmacist if you are allergic to it; or if you have any other||
1435|079|P|allergies. This product may contain inactive ingredients, which||
1435|080|P|can cause allergic reactions or other problems. Talk to your||
1435|081|P|pharmacist for more details.||
1435|082|P|   Before using this medication, tell your doctor or pharmacist||
1435|083|P|your medical history.||
1435|084|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1435|085|P|can make you more dizzy. Do not drive, use machinery, or do||
1435|086|P|anything that needs alertness until you can do it safely. Limit||
1435|087|P|alcoholic beverages. Talk to your doctor if you are using||
1435|088|P|marijuana (cannabis).||
1435|089|P|   Before having surgery, tell your doctor or dentist about all||
1435|090|P|the products you use (including prescription drugs,||
1435|091|P|nonprescription drugs, and herbal products).||
1435|092|P|   During pregnancy, this medication should be used only when||
1435|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
1435|094|P|   It is unknown if this medication passes into breast milk.||
1435|095|P|Consult your doctor before breastfeeding.||
1435|096|B|||
1435|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1435|098|I|medications work or increase your risk for serious side effects.||
1435|099|I|This document does not contain all possible drug interactions.||
1435|100|I|Keep a list of all the products you use (including||
1435|101|I|prescription/nonprescription drugs and herbal products) and share||
1435|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
1435|103|I|the dosage of any medicines without your doctor's approval.||
1435|104|B|||
1435|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1435|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1435|107|O|poison control center right away. US residents can call||
1435|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1435|109|B|||
1435|110|N|NOTES:  Do not share this medication with others.||
1435|111|B|||
1435|112|D|MISSED DOSE:  Not applicable.||
1435|113|B|||
1435|114|R|STORAGE:  Store at room temperature or in the refrigerator. Do||
1435|115|R|not freeze. Keep the medication in the original carton until||
1435|116|R|ready to use. Keep all medications away from children and pets.||
1435|117|R|   Do not flush medications down the toilet or pour them into a||
1435|118|R|drain unless instructed to do so. Properly discard this product||
1435|119|R|when it is expired or no longer needed. Consult your pharmacist||
1435|120|R|or local waste disposal company.||
1435|121|B|||
1435|122|A|Information last revised October 2024.||
1435|123|A|Copyright(c) 2025 First Databank, Inc.||
1435|124|B|||
1436|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1436|002|Z|does NOT have all possible information about this product. This||
1436|003|Z|information does not assure that this product is safe, effective,||
1436|004|Z|or appropriate for you. This information is not individual||
1436|005|Z|medical advice and does not substitute for the advice of your||
1436|006|Z|health care professional. Always ask your health care||
1436|007|Z|professional for complete information about this product and your||
1436|008|Z|specific health needs.||
1436|009|B|||
1436|010|T|LEUPROLIDE 3 MONTH PEDIATRIC - INJECTION||
1436|011|F|(LOO-proe-lide)||
1436|012|B|||
1436|013|C|COMMON BRAND NAME(S): Lupron Depot-Ped||
1436|014|B|||
1436|015|U|USES:  Leuprolide is used to stop early puberty (precocious||
1436|016|U|puberty) in children. It helps to delay sexual development (such||
1436|017|U|as growth of the breasts/testicles) and the start of menstrual||
1436|018|U|periods. It also helps slow down early bone growth to increase||
1436|019|U|the likelihood of reaching normal adult height. Leuprolide works||
1436|020|U|by decreasing the amount of sex hormones that a child's body||
1436|021|U|makes (estrogen in girls, testosterone in boys).||
1436|022|B|||
1436|023|V|OTHER USES:  This section contains uses of this drug that are not||
1436|024|V|listed in the approved professional labeling for the drug but||
1436|025|V|that may be prescribed by your health care professional. Use this||
1436|026|V|drug for a condition that is listed in this section only if it||
1436|027|V|has been so prescribed by your health care professional.||
1436|028|V|   This drug may also be used for gender dysphoria or disorders||
1436|029|V|of the uterus (including endometriosis, fibroids).||
1436|030|B|||
1436|031|H|HOW TO USE:  Read the Medication Guide provided by your||
1436|032|H|pharmacist before you start using leuprolide and each time you||
1436|033|H|get a refill. If you have any questions, ask your doctor or||
1436|034|H|pharmacist.||
1436|035|H|   This medication is given by injection into a muscle by a||
1436|036|H|health care professional as directed by the doctor, usually every||
1436|037|H|3 months. This product slowly releases the medication into the||
1436|038|H|blood over a 3-month period.||
1436|039|H|   Children's dosage is based on weight and response to||
1436|040|H|treatment. The doctor should consider stopping treatment before||
1436|041|H|age 11 for girls and age 12 for boys. Consult the doctor for||
1436|042|H|details.||
1436|043|H|   Use this medication regularly to get the most benefit from it.||
1436|044|H|To help you remember, mark your calendar with a reminder.||
1436|045|H|   During the first few weeks of treatment, hormone levels will||
1436|046|H|actually go up before they go down. This is a normal response to||
1436|047|H|this medication. You may notice worsening symptoms of early||
1436|048|H|puberty (such as menstrual periods) at the start of treatment.||
1436|049|H|However, you should see an improvement in symptoms usually within||
1436|050|H|1 to 2 months. Tell the doctor promptly if new or worsened||
1436|051|H|symptoms develop after starting treatment.||
1436|052|B|||
1436|053|S|SIDE EFFECTS:  Headache, breast changes, increased weight, or||
1436|054|S|mild pain/swelling at the injection site may occur. If any of||
1436|055|S|these effects last or get worse, tell the doctor or pharmacist||
1436|056|S|promptly.||
1436|057|S|   When this medication is used regularly, it is expected that||
1436|058|S|the menstrual period will stop or decrease to light||
1436|059|S|bleeding/spotting during the first 2 months. Tell the doctor||
1436|060|S|promptly if regular periods continue after 2 months of treatment||
1436|061|S|with leuprolide.||
1436|062|S|   Remember that this medication has been prescribed because the||
1436|063|S|doctor has judged that the benefit is greater than the risk of||
1436|064|S|side effects. Many people using this medication do not have||
1436|065|S|serious side effects.||
1436|066|S|   Tell your doctor right away if you have any serious side||
1436|067|S|effects, including: mental/mood changes (such as non-stop crying,||
1436|068|S|irritability, mood swings, aggression).||
1436|069|S|   Get medical help right away if you have any very serious side||
1436|070|S|effects, including: seizures.||
1436|071|S|   Children using leuprolide may be at risk for increased||
1436|072|S|pressure around the brain (intracranial hypertension). Get||
1436|073|S|medical help right away if your child has any of these very||
1436|074|S|serious side effects: nausea/vomiting that doesn't stop, headache||
1436|075|S|that is severe or doesn't go away, eye pain, vision changes (such||
1436|076|S|as blurred/double vision, decreased vision), ringing in the ears.||
1436|077|S|   A very serious allergic reaction to this drug is rare.||
1436|078|S|However, get medical help right away if you notice any symptoms||
1436|079|S|of a serious allergic reaction, including: fever, swollen lymph||
1436|080|S|nodes, rash, itching/swelling (especially of the||
1436|081|S|face/tongue/throat), severe dizziness, trouble breathing.||
1436|082|S|   This is not a complete list of possible side effects. If you||
1436|083|S|notice other effects not listed above, contact the doctor or||
1436|084|S|pharmacist.||
1436|085|S|   In the US -||
1436|086|S|   Call your doctor for medical advice about side effects. You||
1436|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1436|088|S|www.fda.gov/medwatch.||
1436|089|S|   In Canada - Call your doctor for medical advice about side||
1436|090|S|effects. You may report side effects to Health Canada at||
1436|091|S|1-866-234-2345.||
1436|092|B|||
1436|093|P|PRECAUTIONS:  Before using leuprolide, tell the doctor or||
1436|094|P|pharmacist if your child is allergic to it; or to similar drugs||
1436|095|P|(such as histrelin, triptorelin); or if your child has any other||
1436|096|P|allergies. This product may contain inactive ingredients, which||
1436|097|P|can cause allergic reactions or other problems. Talk to the||
1436|098|P|pharmacist for more details.||
1436|099|P|   Before using this medication, tell the doctor or pharmacist||
1436|100|P|the child's medical history, especially of: mental/mood problems||
1436|101|P|(such as depression), seizures.||
1436|102|P|   Before having surgery, tell the doctor or dentist about all||
1436|103|P|the products being used (including prescription drugs,||
1436|104|P|nonprescription drugs, and herbal products).||
1436|105|P|   This medication must not be used during pregnancy. It may harm||
1436|106|P|an unborn baby. Consult your doctor for more details and to||
1436|107|P|discuss using reliable forms of non-hormonal birth control (such||
1436|108|P|as condoms, diaphragm with spermicide) while using this||
1436|109|P|medication. If you become pregnant or think you may be pregnant,||
1436|110|P|tell your doctor right away.||
1436|111|P|   It is unknown if leuprolide passes into breast milk. Because||
1436|112|P|of the possible risk to the infant, breastfeeding is not||
1436|113|P|recommended while using this medication. Consult your doctor||
1436|114|P|before breastfeeding.||
1436|115|B|||
1436|116|I|DRUG INTERACTIONS:  Drug interactions may change how medications||
1436|117|I|work or increase the risk for serious side effects. This document||
1436|118|I|does not contain all possible drug interactions. Keep a list of||
1436|119|I|all the products your child uses (including||
1436|120|I|prescription/nonprescription drugs and herbal products) and share||
1436|121|I|it with the doctor and pharmacist. Do not start, stop, or change||
1436|122|I|the dosage of any medicines without the doctor's approval.||
1436|123|I|   This medication may interfere with certain lab tests possibly||
1436|124|I|causing false test results. Make sure lab personnel and all the||
1436|125|I|doctors know your child uses this drug.||
1436|126|B|||
1436|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1436|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1436|129|O|poison control center right away. US residents can call||
1436|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1436|131|B|||
1436|132|N|NOTES:  Do not share this medication with others.||
1436|133|N|   Lab and/or medical tests (such as hormone levels, height||
1436|134|N|measurements, bone tests) should be done while using this||
1436|135|N|medication. Keep all medical and lab appointments. Consult the||
1436|136|N|doctor for more details.||
1436|137|B|||
1436|138|D|MISSED DOSE:  It is important to get each dose of this medication||
1436|139|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
1436|140|D|right away for a new dosing schedule. Do not double the dose to||
1436|141|D|catch up.||
1436|142|B|||
1436|143|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1436|144|R|doctor's office and will not be stored at home.||
1436|145|B|||
1436|146|A|Information last revised October 2024.||
1436|147|A|Copyright(c) 2025 First Databank, Inc.||
1436|148|B|||
1437|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1437|002|Z|does NOT have all possible information about this product. This||
1437|003|Z|information does not assure that this product is safe, effective,||
1437|004|Z|or appropriate for you. This information is not individual||
1437|005|Z|medical advice and does not substitute for the advice of your||
1437|006|Z|health care professional. Always ask your health care||
1437|007|Z|professional for complete information about this product and your||
1437|008|Z|specific health needs.||
1437|009|B|||
1437|010|T|BRENTUXIMAB - INJECTION||
1437|011|F|(bren-TUX-i-mab)||
1437|012|B|||
1437|013|C|COMMON BRAND NAME(S): Adcetris||
1437|014|B|||
1437|015|W|WARNING:  Rarely, a serious (sometimes fatal) brain infection||
1437|016|W|(Progressive Multifocal Leukoencephalopathy-PML) has occurred in||
1437|017|W|people receiving this medication. Get medical help right away if||
1437|018|W|you develop any signs of PML, including changes in mood, unusual||
1437|019|W|behavior, confusion, difficulty concentrating, changes in||
1437|020|W|vision/speech/walking, decreased strength or weakness on one side||
1437|021|W|of the body.||
1437|022|B|||
1437|023|U|USES:  Brentuximab is used to treat certain types of cancers||
1437|024|U|(Hodgkin's lymphoma, systemic anaplastic large cell lymphoma,||
1437|025|U|peripheral T-cell lymphoma, primary cutaneous anaplastic large||
1437|026|U|cell lymphoma, mycosis fungoides, large B-cell lymphoma). It||
1437|027|U|works by slowing or stopping the growth of cancer cells.||
1437|028|B|||
1437|029|H|HOW TO USE:  This medication is given by injection into a vein||
1437|030|H|over 30 minutes by a health care professional. It is given as||
1437|031|H|directed by your doctor, usually once every 2 or 3 weeks.||
1437|032|H|   The dosage is based on your medical condition, weight, and||
1437|033|H|response to treatment.||
1437|034|H|   Your health care professional will monitor you during the||
1437|035|H|infusion in case you develop a reaction to brentuximab. If a rare||
1437|036|H|but severe allergic reaction occurs, the infusion will be stopped||
1437|037|H|and you should never receive brentuximab again. If a less serious||
1437|038|H|reaction occurs, the infusion will be interrupted, you will be||
1437|039|H|treated for the reaction, and the infusion will be continued. If||
1437|040|H|you develop a less serious infusion reaction, you will be||
1437|041|H|directed by your doctor to take certain medications (such as||
1437|042|H|acetaminophen, antihistamines, corticosteroids) before each||
1437|043|H|future brentuximab infusion to lessen the chance of symptoms.||
1437|044|H|Consult your doctor for more details. Get medical help right away||
1437|045|H|if you have symptoms such as fever, chills, rash, itching, cough,||
1437|046|H|or trouble breathing within 24 hours of the infusion.||
1437|047|B|||
1437|048|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1437|049|S|   Nausea, vomiting, diarrhea, dizziness, headache, or unusual||
1437|050|S|tiredness may occur. If any of these effects last or get worse,||
1437|051|S|tell your doctor or pharmacist promptly.||
1437|052|S|   Remember that this medication has been prescribed because your||
1437|053|S|doctor has judged that the benefit to you is greater than the||
1437|054|S|risk of side effects. Many people using this medication do not||
1437|055|S|have serious side effects.||
1437|056|S|   This medication may rarely make your blood sugar rise, which||
1437|057|S|can cause or worsen diabetes. Tell your doctor right away if you||
1437|058|S|have symptoms of high blood sugar, such as increased||
1437|059|S|thirst/urination. If you already have diabetes, check your blood||
1437|060|S|sugar regularly as directed and share the results with your||
1437|061|S|doctor. Your doctor may need to adjust your diabetes medication,||
1437|062|S|exercise program, or diet.||
1437|063|S|   Tell your doctor right away if you have any serious side||
1437|064|S|effects, including: numbness/tingling/weakness/pain of the||
1437|065|S|hands/feet/arms/legs, muscle weakness, shortness of breath, easy||
1437|066|S|bruising/bleeding, signs of liver disease (such as||
1437|067|S|nausea/vomiting that doesn't stop, loss of appetite,||
1437|068|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), severe||
1437|069|S|diarrhea, severe constipation, black stools, vomit that looks||
1437|070|S|like coffee grounds.||
1437|071|S|   This medication may lower your ability to fight infections.||
1437|072|S|This may make you more likely to get a serious (rarely fatal)||
1437|073|S|infection or make any infection you have worse. Get medical help||
1437|074|S|right away if you have any signs of infection (such as sore||
1437|075|S|throat that doesn't go away, fever, swollen lymph nodes, chills).||
1437|076|S|   Brentuximab sometimes causes side effects due to the rapid||
1437|077|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1437|078|S|risk, your doctor may add a medication and tell you to drink||
1437|079|S|plenty of fluids. Tell your doctor right away if you have||
1437|080|S|symptoms such as: low back/side pain (flank pain), signs of||
1437|081|S|kidney problems (such as painful urination, pink/bloody urine,||
1437|082|S|change in the amount of urine), muscle spasms/weakness.||
1437|083|S|   A very serious allergic reaction to this drug is rare.||
1437|084|S|However, get medical help right away if you notice any symptoms||
1437|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1437|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1437|087|S|breathing.||
1437|088|S|   This is not a complete list of possible side effects. If you||
1437|089|S|notice other effects not listed above, contact your doctor or||
1437|090|S|pharmacist.||
1437|091|S|   In the US -||
1437|092|S|   Call your doctor for medical advice about side effects. You||
1437|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1437|094|S|www.fda.gov/medwatch.||
1437|095|S|   In Canada - Call your doctor for medical advice about side||
1437|096|S|effects. You may report side effects to Health Canada at||
1437|097|S|1-866-234-2345.||
1437|098|B|||
1437|099|P|PRECAUTIONS:  Before using brentuximab, tell your doctor or||
1437|100|P|pharmacist if you are allergic to it; or if you have any other||
1437|101|P|allergies. This product may contain inactive ingredients, which||
1437|102|P|can cause allergic reactions or other problems. Talk to your||
1437|103|P|pharmacist for more details.||
1437|104|P|   Before using this medication, tell your doctor or pharmacist||
1437|105|P|your medical history, especially of: kidney disease, liver||
1437|106|P|disease, diabetes.||
1437|107|P|   Brentuximab can make you more likely to get infections or may||
1437|108|P|make current infections worse. Stay away from anyone who has an||
1437|109|P|infection that may easily spread (such as chickenpox, COVID-19,||
1437|110|P|measles, flu). Talk to your doctor if you have been exposed to an||
1437|111|P|infection or for more details.||
1437|112|P|   Tell your health care professional that you are using||
1437|113|P|brentuximab before having any immunizations/vaccinations. Avoid||
1437|114|P|contact with people who have recently received live vaccines||
1437|115|P|(such as flu vaccine inhaled through the nose).||
1437|116|P|   To lower the chance of getting cut, bruised, or injured, use||
1437|117|P|caution with sharp objects like razors and nail cutters, and||
1437|118|P|avoid activities such as contact sports.||
1437|119|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1437|120|P|can make you more dizzy. Do not drive, use machinery, or do||
1437|121|P|anything that needs alertness until you can do it safely. Limit||
1437|122|P|alcoholic beverages. Talk to your doctor if you are using||
1437|123|P|marijuana (cannabis).||
1437|124|P|   Before having surgery, tell your doctor or dentist about all||
1437|125|P|the products you use (including prescription drugs,||
1437|126|P|nonprescription drugs, and herbal products).||
1437|127|P|   Older adults may be more sensitive to the side effects of this||
1437|128|P|drug.||
1437|129|P|   Tell your doctor if you are pregnant or plan to become||
1437|130|P|pregnant. You should not become pregnant while using brentuximab.||
1437|131|P|Brentuximab may harm an unborn baby. Your doctor should order a||
1437|132|P|pregnancy test before you start this medication. Women using this||
1437|133|P|medication should ask about reliable forms of birth control||
1437|134|P|during treatment and for 2 months after the last dose. Men using||
1437|135|P|this medication should ask about reliable forms of birth control||
1437|136|P|during treatment and for 4 months after the last dose. If you or||
1437|137|P|your partner becomes pregnant, talk to your doctor right away||
1437|138|P|about the risks and benefits of this medication.||
1437|139|P|   It is unknown if this medication passes into breast milk.||
1437|140|P|Because of the possible risk to the infant, breastfeeding is not||
1437|141|P|recommended while using this medication. Consult your doctor||
1437|142|P|before breastfeeding.||
1437|143|B|||
1437|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1437|145|I|medications work or increase your risk for serious side effects.||
1437|146|I|This document does not contain all possible drug interactions.||
1437|147|I|Keep a list of all the products you use (including||
1437|148|I|prescription/nonprescription drugs and herbal products) and share||
1437|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
1437|150|I|the dosage of any medicines without your doctor's approval.||
1437|151|I|   Some products that may interact with this drug include:||
1437|152|I|bleomycin, other drugs that weaken the immune system/increase the||
1437|153|I|risk of infection (such as natalizumab, rituximab).||
1437|154|B|||
1437|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1437|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1437|157|O|poison control center right away. US residents can call||
1437|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1437|159|B|||
1437|160|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
1437|161|N|kidney/liver function, blood sugar) should be done while you are||
1437|162|N|using this medication. Keep all medical and lab appointments.||
1437|163|N|Consult your doctor for more details.||
1437|164|B|||
1437|165|D|MISSED DOSE:  It is important to get each dose of this medication||
1437|166|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1437|167|D|right away for a new dosing schedule.||
1437|168|B|||
1437|169|R|STORAGE:  Not applicable. This medication is given in a hospital||
1437|170|R|or clinic and will not be stored at home.||
1437|171|B|||
1437|172|M|MEDICAL ALERT:  Your condition can cause complications in a||
1437|173|M|medical emergency. For information about enrolling in MedicAlert,||
1437|174|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1437|175|B|||
1437|176|A|Information last revised April 2025.||
1437|177|A|Copyright(c) 2025 First Databank, Inc.||
1437|178|B|||
1439|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1439|002|Z|does NOT have all possible information about this product. This||
1439|003|Z|information does not assure that this product is safe, effective,||
1439|004|Z|or appropriate for you. This information is not individual||
1439|005|Z|medical advice and does not substitute for the advice of your||
1439|006|Z|health care professional. Always ask your health care||
1439|007|Z|professional for complete information about this product and your||
1439|008|Z|specific health needs.||
1439|009|B|||
1439|010|T|AXITINIB - ORAL||
1439|011|F|(ax-I-ti-nib)||
1439|012|B|||
1439|013|C|COMMON BRAND NAME(S): Inlyta||
1439|014|B|||
1439|015|U|USES:  This medication is used to treat kidney cancer. Axitinib||
1439|016|U|works by slowing or stopping the growth of cancer cells. It||
1439|017|U|belongs to a class of drugs known as tyrosine kinase inhibitors.||
1439|018|B|||
1439|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1439|020|H|from your pharmacist before you start using axitinib and each||
1439|021|H|time you get a refill. If you have any questions, ask your doctor||
1439|022|H|or pharmacist.||
1439|023|H|   Take this medication by mouth with or without food as directed||
1439|024|H|by your doctor, usually two times daily (about 12 hours apart).||
1439|025|H|Swallow the tablet whole with a glass of water. Do not split or||
1439|026|H|crush this medication.||
1439|027|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1439|028|H|using this medication unless your doctor or pharmacist says you||
1439|029|H|may do so safely. Grapefruit can increase the chance of side||
1439|030|H|effects with this medicine. Ask your doctor or pharmacist for||
1439|031|H|more details.||
1439|032|H|   The dosage is based on your medical condition, response to||
1439|033|H|treatment, and other medications you may be taking. Be sure to||
1439|034|H|tell your doctor and pharmacist about all the products you use||
1439|035|H|(including prescription drugs, nonprescription drugs, and herbal||
1439|036|H|products). If you have certain side effects, your doctor may||
1439|037|H|adjust your dose or stop treatment for some time.||
1439|038|H|   Do not increase your dose or use this drug more often or for||
1439|039|H|longer than prescribed. Your condition will not improve any||
1439|040|H|faster, and your risk of serious side effects will increase.||
1439|041|H|   If you vomit your dose of axitinib, do not take an additional||
1439|042|H|dose. Take your next dose at your regular scheduled time. Do not||
1439|043|H|take two doses at the same time.||
1439|044|H|   Take this medication regularly to get the most benefit from||
1439|045|H|it. To help you remember, take it at the same times each day.||
1439|046|H|   Since this drug can be absorbed through the skin and lungs and||
1439|047|H|may harm an unborn baby, women who are pregnant or who may become||
1439|048|H|pregnant should not handle this medication or breathe the dust||
1439|049|H|from the tablets.||
1439|050|B|||
1439|051|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, dizziness,||
1439|052|S|tiredness/weakness, weight loss, temporary hair loss, dry skin,||
1439|053|S|cough, headache, altered sense of taste, hoarseness,||
1439|054|S|constipation, or upset stomach may occur. If any of these effects||
1439|055|S|last or get worse, tell your doctor or pharmacist promptly.||
1439|056|S|   Diarrhea is a common side effect that can cause dehydration.||
1439|057|S|Drink plenty of fluids to reduce the risk of dehydration. Tell||
1439|058|S|your doctor right away if you develop signs of dehydration (such||
1439|059|S|as dizziness/lightheadedness, unusual dry mouth/thirst).||
1439|060|S|   Remember that this medication has been prescribed because your||
1439|061|S|doctor has judged that the benefit to you is greater than the||
1439|062|S|risk of side effects. Many people using this medication do not||
1439|063|S|have serious side effects.||
1439|064|S|   Tell your doctor right away if you have any serious side||
1439|065|S|effects, including: signs of kidney problems (such as change in||
1439|066|S|the amount of urine, foamy urine), muscle/joint pain, swelling of||
1439|067|S|ankles/feet/hands, unusual tiredness, shortness of breath, easy||
1439|068|S|bruising or bleeding (such as nose/gum bleeds, pink/dark urine),||
1439|069|S|burning/sores/pain in the mouth or throat,||
1439|070|S|redness/blisters/swelling/pain on the palms of your hands or||
1439|071|S|soles of your feet, slow wound healing, signs of an abnormal||
1439|072|S|thyroid (such as unusual weight gain/loss, cold/heat intolerance,||
1439|073|S|slow/fast/irregular heartbeat, unusual tiredness), signs of liver||
1439|074|S|problems (such as nausea/vomiting that doesn't stop, loss of||
1439|075|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1439|076|S|urine).||
1439|077|S|   This medication may lower your ability to fight infections.||
1439|078|S|This may make you more likely to get a serious infection or make||
1439|079|S|any infection you have worse. Tell your doctor right away if have||
1439|080|S|any signs of infection (such as sore throat that doesn't go away,||
1439|081|S|fever, chills).||
1439|082|S|   This medication may raise your blood pressure. Check your||
1439|083|S|blood pressure regularly and tell your doctor if the results are||
1439|084|S|high. Your doctor may control your blood pressure with||
1439|085|S|medication.||
1439|086|S|   Rarely, axitinib may cause a condition known as RPLS||
1439|087|S|(reversible posterior leukoencephalopathy syndrome). Get medical||
1439|088|S|help right away if you develop headache that doesn't go away,||
1439|089|S|seizures, sudden vision changes, mental/mood changes (such as||
1439|090|S|confusion).||
1439|091|S|   This medication may rarely cause serious (sometimes fatal)||
1439|092|S|problems from blood clots (such as heart attack, stroke, blood||
1439|093|S|clots in the lungs, legs, or eyes). You may be at increased risk||
1439|094|S|for blood clots if you are severely dehydrated, or have a history||
1439|095|S|of blood clots, heart/blood vessel disease, heart failure,||
1439|096|S|stroke, or if you are immobile (such as on very long plane||
1439|097|S|flights or being bedridden). If you use estrogen-containing||
1439|098|S|products, these may also increase your risk. Before using this||
1439|099|S|medication, if you have any of these conditions report them to||
1439|100|S|your doctor or pharmacist. Get medical help right away if any of||
1439|101|S|these side effects occur: shortness of breath/rapid breathing,||
1439|102|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1439|103|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1439|104|S|sudden/severe headaches, trouble speaking, weakness on one side||
1439|105|S|of the body, sudden vision changes.||
1439|106|S|   Get medical help right away if you have any very serious side||
1439|107|S|effects, including: severe stomach/abdominal pain that doesn't go||
1439|108|S|away, signs of bleeding (such as bloody/black stools, vomit that||
1439|109|S|looks like coffee grounds, coughing/vomiting up blood),||
1439|110|S|sudden/severe back pain.||
1439|111|S|   Axitinib can commonly cause a rash that is usually not||
1439|112|S|serious. However, you may not be able to tell it apart from a||
1439|113|S|rare rash that could be a sign of a severe reaction. Get medical||
1439|114|S|help right away if you develop any rash.||
1439|115|S|   A very serious allergic reaction to this drug is rare.||
1439|116|S|However, get medical help right away if you notice any symptoms||
1439|117|S|of a serious allergic reaction, including: rash, itching/swelling||
1439|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1439|119|S|breathing.||
1439|120|S|   This is not a complete list of possible side effects. If you||
1439|121|S|notice other effects not listed above, contact your doctor or||
1439|122|S|pharmacist.||
1439|123|S|   In the US -||
1439|124|S|   Call your doctor for medical advice about side effects. You||
1439|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1439|126|S|www.fda.gov/medwatch.||
1439|127|S|   In Canada - Call your doctor for medical advice about side||
1439|128|S|effects. You may report side effects to Health Canada at||
1439|129|S|1-866-234-2345.||
1439|130|B|||
1439|131|P|PRECAUTIONS:  See also Side Effects section.||
1439|132|P|   Before taking axitinib, tell your doctor or pharmacist if you||
1439|133|P|are allergic to it; or if you have any other allergies. This||
1439|134|P|product may contain inactive ingredients, which can cause||
1439|135|P|allergic reactions or other problems. Talk to your pharmacist for||
1439|136|P|more details.||
1439|137|P|   Before using this medication, tell your doctor or pharmacist||
1439|138|P|your medical history, especially of: liver disease, kidney||
1439|139|P|disease, high blood pressure, bleeding/clotting problems (such as||
1439|140|P|bleeding from intestinal/stomach ulcers), blood vessel problems||
1439|141|P|(such as an aneurysm or a tear/break in the aorta or other blood||
1439|142|P|vessels), heart problems (such as heart failure, previous heart||
1439|143|P|attack), thyroid problems.||
1439|144|P|   Axitinib can make you more likely to get infections or may||
1439|145|P|make current infections worse. Stay away from anyone who has an||
1439|146|P|infection that may easily spread (such as chickenpox, COVID-19,||
1439|147|P|measles, flu). Talk to your doctor if you have been exposed to an||
1439|148|P|infection or for more details.||
1439|149|P|   Tell your health care professional that you are using axitinib||
1439|150|P|before having any immunizations/vaccinations. Avoid contact with||
1439|151|P|people who have recently received live vaccines (such as flu||
1439|152|P|vaccine inhaled through the nose).||
1439|153|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1439|154|P|can make you more dizzy. Do not drive, use machinery, or do||
1439|155|P|anything that needs alertness until you can do it safely. Limit||
1439|156|P|alcoholic beverages. Talk to your doctor if you are using||
1439|157|P|marijuana (cannabis).||
1439|158|P|   Before having surgery, tell your doctor or dentist about all||
1439|159|P|the products you use (including prescription drugs,||
1439|160|P|nonprescription drugs, and herbal products).||
1439|161|P|   This medication may cause wounds to heal slowly or poorly.||
1439|162|P|Before having surgery, talk with your doctor about the risks and||
1439|163|P|benefits of this medication. Your doctor may tell you to||
1439|164|P|temporarily stop treatment with this medication at least 2 days||
1439|165|P|before surgery. Ask your doctor for specific instructions about||
1439|166|P|when to stop and when to restart treatment with axitinib. Tell||
1439|167|P|your doctor right away if you have wounds that are not healing||
1439|168|P|well.||
1439|169|P|   Since this drug can be absorbed through the skin and lungs and||
1439|170|P|may harm an unborn baby, women who are pregnant or who may become||
1439|171|P|pregnant should not handle this medication or breathe the dust||
1439|172|P|from the tablets.||
1439|173|P|   Tell your doctor if you are pregnant or plan to become||
1439|174|P|pregnant. You should not become pregnant while using axitinib.||
1439|175|P|Axitinib may harm an unborn baby. Your doctor should order a||
1439|176|P|pregnancy test before you start this medication. Men and women||
1439|177|P|using this medication should ask about reliable forms of birth||
1439|178|P|control during treatment and for at least 1 week after the last||
1439|179|P|dose. If you or your partner becomes pregnant, talk to your||
1439|180|P|doctor right away about the risks and benefits of this||
1439|181|P|medication.||
1439|182|P|   It is unknown if this medication passes into breast milk.||
1439|183|P|Because of the possible risk to the infant, breastfeeding is not||
1439|184|P|recommended while using this medication and for at least 2 weeks||
1439|185|P|after the last dose. Consult your doctor before breastfeeding.||
1439|186|B|||
1439|187|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1439|188|I|medications work or increase your risk for serious side effects.||
1439|189|I|This document does not contain all possible drug interactions.||
1439|190|I|Keep a list of all the products you use (including||
1439|191|I|prescription/nonprescription drugs and herbal products) and share||
1439|192|I|it with your doctor and pharmacist. Do not start, stop, or change||
1439|193|I|the dosage of any medicines without your doctor's approval.||
1439|194|I|   Other medications can affect the removal of axitinib from your||
1439|195|I|body, which may affect how axitinib works. Examples include||
1439|196|I|rifamycins (such as rifampin, rifabutin, rifapentine), drugs to||
1439|197|I|treat seizures (such as phenytoin, carbamazepine, phenobarbital),||
1439|198|I|St. John's wort, bosentan, efavirenz, modafinil, nafcillin,||
1439|199|I|etravirine, dexamethasone, among others.||
1439|200|B|||
1439|201|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1439|202|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1439|203|O|poison control center right away. US residents can call||
1439|204|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1439|205|O|Symptoms of overdose may include: seizures, extreme dizziness,||
1439|206|O|vomiting blood.||
1439|207|B|||
1439|208|N|NOTES:  Do not share this medication with others.||
1439|209|N|   Lab and/or medical tests (such as blood pressure,||
1439|210|N|thyroid/kidney/liver/pancreatic function, complete blood counts,||
1439|211|N|urine tests, blood mineral levels including sodium/potassium)||
1439|212|N|should be done while you are taking this medication. Keep all||
1439|213|N|medical and lab appointments.||
1439|214|B|||
1439|215|D|MISSED DOSE:  It is important to get each dose of this medication||
1439|216|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1439|217|D|right away for a new dosing schedule. Do not double the dose to||
1439|218|D|catch up.||
1439|219|B|||
1439|220|R|STORAGE:  Store at room temperature away from light and moisture.||
1439|221|R|Do not store in the bathroom. Keep all medications away from||
1439|222|R|children and pets.||
1439|223|R|   Do not flush medications down the toilet or pour them into a||
1439|224|R|drain unless instructed to do so. Properly discard this product||
1439|225|R|when it is expired or no longer needed. Consult your pharmacist||
1439|226|R|or local waste disposal company.||
1439|227|B|||
1439|228|M|MEDICAL ALERT:  Your condition can cause complications in a||
1439|229|M|medical emergency. For information about enrolling in MedicAlert,||
1439|230|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1439|231|B|||
1439|232|A|Information last revised January 2025.||
1439|233|A|Copyright(c) 2025 First Databank, Inc.||
1439|234|B|||
1441|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1441|002|Z|does NOT have all possible information about this product. This||
1441|003|Z|information does not assure that this product is safe, effective,||
1441|004|Z|or appropriate for you. This information is not individual||
1441|005|Z|medical advice and does not substitute for the advice of your||
1441|006|Z|health care professional. Always ask your health care||
1441|007|Z|professional for complete information about this product and your||
1441|008|Z|specific health needs.||
1441|009|B|||
1441|010|T|METHENAMINE/METH BLUE/SALICYLATE/ACIDIFIER/HYOSCYAMINE - ORAL||
1441|011|F|(meth-EN-a-meen/METH-i-leen bloo/sa-LIS-i-late/Acidifier/||
1441|012|F|HYE-oh-SYE-a-meen)||
1441|013|B|||
1441|014|C|COMMON BRAND NAME(S): Hyophen, Phosphasal, Urelle, Uribel,||
1441|015|C|Urimar-T||
1441|016|B|||
1441|017|U|USES:  This medication is used to relieve the discomfort, pain,||
1441|018|U|frequent urge to urinate, and cramps/spasms of the urinary tract||
1441|019|U|caused by an infection or a medical procedure. Methenamine is an||
1441|020|U|antibacterial drug. Methylene blue is an antiseptic and is||
1441|021|U|related to a group of drugs called monoamine oxidase inhibitors||
1441|022|U|(MAO inhibitors). Both methenamine and methylene blue help to||
1441|023|U|prevent the growth of bacteria in the urine. Salicylate, which is||
1441|024|U|related to aspirin, is a pain reliever. This product also||
1441|025|U|contains an ingredient (such as sodium phosphate, benzoic acid)||
1441|026|U|to make the urine more acidic, which helps methenamine work||
1441|027|U|better. Hyoscyamine is an antispasmodic drug that relaxes the||
1441|028|U|muscles of the urinary tract to relieve cramps/spasms.||
1441|029|U|   This product should not be used to treat a urinary tract||
1441|030|U|infection. If you have a bacterial infection, an antibiotic is||
1441|031|U|usually prescribed to treat it. Consult your doctor for more||
1441|032|U|details.||
1441|033|U|   This medication is not recommended for children younger than 6||
1441|034|U|years because they are more sensitive to the side effects.||
1441|035|B|||
1441|036|H|HOW TO USE:  Take this medication by mouth as directed by your||
1441|037|H|doctor, usually 4 times a day. Take each dose with a full glass||
1441|038|H|of water (8 ounces/240 milliliters). Do not lie down for at least||
1441|039|H|10 minutes after taking this medication. Drink plenty of fluids||
1441|040|H|while you are being treated with this medication unless otherwise||
1441|041|H|directed by your doctor. If stomach upset occurs with this||
1441|042|H|medication, you may take it with food.||
1441|043|H|   The dosage is based on your medical condition, age, and||
1441|044|H|response to treatment. Do not increase your dose or use this drug||
1441|045|H|more often or for longer than prescribed. Your condition will not||
1441|046|H|improve any faster, and your risk of side effects will increase.||
1441|047|H|   Antacids may decrease the absorption and the effectiveness of||
1441|048|H|this product. If you are also taking antacids, take this product||
1441|049|H|at least 1 hour before antacids.||
1441|050|H|   For the best effect, take this medication at evenly spaced||
1441|051|H|times. To help you remember, take it at the same times each day.||
1441|052|H|   Caffeine can increase the side effects of this medication.||
1441|053|H|Avoid drinking large amounts of beverages containing caffeine||
1441|054|H|(coffee, tea, colas), eating large amounts of chocolate, or||
1441|055|H|taking nonprescription products that contain caffeine.||
1441|056|H|   Tell your doctor if your condition does not get better in a||
1441|057|H|few days or if you develop signs of a urinary tract infection||
1441|058|H|(such as burning/painful/frequent urination).||
1441|059|B|||
1441|060|S|SIDE EFFECTS:  Nausea, vomiting, dry mouth, dizziness,||
1441|061|S|drowsiness, blurred vision, or constipation may occur. If any of||
1441|062|S|these effects last or get worse, tell your doctor or pharmacist||
1441|063|S|promptly.||
1441|064|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
1441|065|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1441|066|S|substitute.||
1441|067|S|   This medication causes urine and sometimes stools to turn||
1441|068|S|blue-green. This effect is harmless and will disappear when the||
1441|069|S|medication is stopped.||
1441|070|S|   Remember that this medication has been prescribed because your||
1441|071|S|doctor has judged that the benefit to you is greater than the||
1441|072|S|risk of side effects. Many people using this medication do not||
1441|073|S|have serious side effects.||
1441|074|S|   Tell your doctor right away if you have any serious side||
1441|075|S|effects, including: hot/dry/flushed skin, decreased sweating, eye||
1441|076|S|pain, difficult urination, signs of kidney problems (such as||
1441|077|S|change in the amount of urine, painful urination).||
1441|078|S|   Get medical help right away if you have any very serious side||
1441|079|S|effects, including: easy bruising/bleeding, black/tarry stools,||
1441|080|S|stomach/abdominal pain, vomit that looks like coffee grounds,||
1441|081|S|signs of liver problems (such as nausea/vomiting that doesn't||
1441|082|S|stop, unusual tiredness, dark urine, yellowing eyes/skin).||
1441|083|S|   This drug may rarely cause an attack of extremely high blood||
1441|084|S|pressure (hypertensive crisis), which may be fatal. Many drug||
1441|085|S|interactions can increase this risk (see Drug Interactions||
1441|086|S|section). Get medical help right away if any of these serious||
1441|087|S|side effects occur: severe headache, fast/slow/irregular/pounding||
1441|088|S|heartbeat, chest pain, neck stiffness/soreness, severe||
1441|089|S|nausea/vomiting, sweaty/clammy skin (sometimes with fever),||
1441|090|S|widened pupils, vision changes (such as double/blurred vision),||
1441|091|S|sudden sensitivity to light (photophobia).||
1441|092|S|   A very serious allergic reaction to this drug is rare.||
1441|093|S|However, get medical help right away if you notice any symptoms||
1441|094|S|of a serious allergic reaction, including: rash, itching/swelling||
1441|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1441|096|S|breathing.||
1441|097|S|   This is not a complete list of possible side effects. If you||
1441|098|S|notice other effects not listed above, contact your doctor or||
1441|099|S|pharmacist.||
1441|100|S|   In the US -||
1441|101|S|   Call your doctor for medical advice about side effects. You||
1441|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1441|103|S|www.fda.gov/medwatch.||
1441|104|S|   In Canada - Call your doctor for medical advice about side||
1441|105|S|effects. You may report side effects to Health Canada at||
1441|106|S|1-866-234-2345.||
1441|107|B|||
1441|108|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1441|109|P|pharmacist if you are allergic to any of its ingredients; or to||
1441|110|P|aspirin or NSAIDs (such as ibuprofen); or to belladonna alkaloids||
1441|111|P|(such as atropine, scopolamine); or if you have any other||
1441|112|P|allergies. This product may contain inactive ingredients, which||
1441|113|P|can cause allergic reactions or other problems. Talk to your||
1441|114|P|pharmacist for more details.||
1441|115|P|   Before using this medication, tell your doctor or pharmacist||
1441|116|P|your medical history, especially of: kidney problems, liver||
1441|117|P|problems, urinary blockage problems, difficulty urinating (such||
1441|118|P|as due to an enlarged prostate), stomach/intestinal disorders||
1441|119|P|(such as obstruction, ulcers), glaucoma (narrow angle type),||
1441|120|P|heart problems (such as coronary heart disease, heart failure,||
1441|121|P|fast/irregular heartbeat), high blood pressure, myasthenia||
1441|122|P|gravis, bleeding/clotting problems, certain enzyme deficiencies||
1441|123|P|(pyruvate kinase or G6PD deficiency), asthma (including a history||
1441|124|P|of worsening breathing after taking aspirin or other NSAIDs),||
1441|125|P|growths in the nose (nasal polyps), stroke, severe/frequent||
1441|126|P|headaches, a certain adrenal gland tumor (pheochromocytoma),||
1441|127|P|dehydration.||
1441|128|P|   This drug may make you dizzy or drowsy or blur your vision.||
1441|129|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1441|130|P|drowsy. Do not drive, use machinery, or do anything that needs||
1441|131|P|alertness or clear vision until you can do it safely. Limit||
1441|132|P|alcoholic beverages. Talk to your doctor if you are using||
1441|133|P|marijuana (cannabis).||
1441|134|P|   Also, limit tobacco and alcohol use to lower the risk of||
1441|135|P|stomach bleeding.||
1441|136|P|   This medication may make you sweat less, making you more||
1441|137|P|likely to get heat stroke. Avoid doing things that may cause you||
1441|138|P|to overheat, such as hard work or exercise in hot weather, or||
1441|139|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1441|140|P|and dress lightly. If you overheat, quickly look for a place to||
1441|141|P|cool down and rest. Get medical help right away if you have a||
1441|142|P|fever that does not go away, mental/mood changes, headache, or||
1441|143|P|dizziness.||
1441|144|P|   Before having surgery, tell your doctor or dentist about all||
1441|145|P|the products you use (including prescription drugs,||
1441|146|P|nonprescription drugs, and herbal products).||
1441|147|P|   Children are more sensitive to the side effects of this drug,||
1441|148|P|especially unusual excitement, hot/dry/flushed skin, decreased||
1441|149|P|sweating.||
1441|150|P|   This product contains salicylate, which is related to aspirin.||
1441|151|P|Children and teenagers younger than 18 years should not take||
1441|152|P|aspirin or aspirin-related medications if they have chickenpox,||
1441|153|P|flu, or any undiagnosed illness, or if they have recently||
1441|154|P|received a live virus vaccine (such as flu vaccine given in the||
1441|155|P|nose, varicella vaccine), without first consulting the doctor. A||
1441|156|P|rare but serious illness known as Reye's syndrome may occur.||
1441|157|P|   Older adults may be more sensitive to the side effects of this||
1441|158|P|drug, especially confusion, agitation, drowsiness, unusual||
1441|159|P|excitement, constipation, and difficulty urinating. Confusion and||
1441|160|P|drowsiness can increase the risk of falling.||
1441|161|P|   Tell your doctor if you are pregnant or if you plan to become||
1441|162|P|pregnant. This medication may harm an unborn baby and cause||
1441|163|P|problems with normal labor/delivery. It is not recommended for||
1441|164|P|use in pregnancy from 20 weeks until delivery. If your doctor||
1441|165|P|decides that you need to use this medication between 20 and 30||
1441|166|P|weeks of pregnancy, you should use the lowest effective dose for||
1441|167|P|the shortest possible time. You should not use this medication||
1441|168|P|after 30 weeks of pregnancy. Discuss the risks and benefits with||
1441|169|P|your doctor.||
1441|170|P|   This medication passes into breast milk and may have||
1441|171|P|undesirable effects on a nursing infant. Consult your doctor||
1441|172|P|before breastfeeding.||
1441|173|B|||
1441|174|I|DRUG INTERACTIONS:  See also How to Use section.||
1441|175|I|   Drug interactions may change how your medications work or||
1441|176|I|increase your risk for serious side effects. This document does||
1441|177|I|not contain all possible drug interactions. Keep a list of all||
1441|178|I|the products you use (including prescription/nonprescription||
1441|179|I|drugs and herbal products) and share it with your doctor and||
1441|180|I|pharmacist. Do not start, stop, or change the dosage of any||
1441|181|I|medicines without your doctor's approval.||
1441|182|I|   This medication may interact with many products. Some products||
1441|183|I|include: apraclonidine, atomoxetine, bupropion, carbamazepine,||
1441|184|I|dichlorphenamide, methotrexate, mifepristone, potassium||
1441|185|I|capsules/tablets, pramlintide, tetrabenazine, certain Parkinson's||
1441|186|I|disease drugs (entacapone, levodopa, tolcapone), certain high||
1441|187|I|blood pressure drugs (guanethidine, methyldopa), sulfonamide||
1441|188|I|drugs (including sulfa antibiotics such as sulfamethoxazole),||
1441|189|I|sympathomimetics (such as amphetamine, ephedrine), products that||
1441|190|I|decrease the amount of acid in the urine (such as antacids,||
1441|191|I|sodium bicarbonate, potassium/sodium citrate, acetazolamide).||
1441|192|I|   This medication may increase the risk of bleeding when taken||
1441|193|I|with other drugs that also may cause bleeding. Examples include||
1441|194|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1441|195|I|dabigatran/enoxaparin/warfarin, among others.||
1441|196|I|   Taking other MAO inhibitors with this medication may cause a||
1441|197|I|serious (possibly fatal) drug interaction. Avoid taking other MAO||
1441|198|I|inhibitors (isocarboxazid, linezolid, metaxalone, moclobemide,||
1441|199|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline,||
1441|200|I|tranylcypromine) during treatment with this medication. Most MAO||
1441|201|I|inhibitors should also not be taken for two weeks before and||
1441|202|I|after treatment with this medication. Ask your doctor when to||
1441|203|I|start or stop taking this medication.||
1441|204|I|   Before using this product, report the use of other drugs that||
1441|205|I|may increase the risk of extremely high blood pressure||
1441|206|I|(hypertensive crisis) when combined with this product, including||
1441|207|I|herbal products (such as ephedra/ma huang), nasal decongestants||
1441|208|I|(such as phenylephrine, pseudoephedrine), stimulants (such as||
1441|209|I|amphetamines, ephedrine, epinephrine), diet aids, among others.||
1441|210|I|This product should not be used with any of these medications.||
1441|211|I|Talk to your doctor or pharmacist for more details.||
1441|212|I|   If you are also taking azole antifungal drugs (such as||
1441|213|I|itraconazole, ketoconazole), take this product at least 2 hours||
1441|214|I|after the antifungal drug.||
1441|215|I|   Check all prescription and nonprescription medicine labels||
1441|216|I|carefully since many medications contain pain relievers/fever||
1441|217|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac or||
1441|218|I|naproxen). These drugs are similar to salicylate and may increase||
1441|219|I|your risk of side effects if taken together. However, if your||
1441|220|I|doctor has told you to take low-dose aspirin to prevent heart||
1441|221|I|attack or stroke (usually 81-162 milligrams a day), you should||
1441|222|I|keep taking the aspirin unless your doctor tells you not to. Ask||
1441|223|I|your doctor or pharmacist for more details.||
1441|224|I|   Tell your doctor or pharmacist if you are taking other||
1441|225|I|products that cause drowsiness including alcohol, marijuana||
1441|226|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1441|227|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1441|228|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1441|229|I|codeine).||
1441|230|I|   Check the labels on all your medicines (such as allergy or||
1441|231|I|cough-and-cold products) because they may contain ingredients||
1441|232|I|that cause drowsiness. Ask your pharmacist about using those||
1441|233|I|products safely.||
1441|234|I|   This medication may interfere with certain lab tests, possibly||
1441|235|I|causing false test results. Make sure lab personnel and all your||
1441|236|I|doctors know you use this drug.||
1441|237|B|||
1441|238|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1441|239|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1441|240|O|poison control center right away. US residents can call||
1441|241|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1441|242|O|Symptoms of overdose may include: fever, fast/pounding heartbeat,||
1441|243|O|severe dizziness, seizures, slowed/shallow breathing, unusual||
1441|244|O|excitement.||
1441|245|B|||
1441|246|N|NOTES:  Do not share this medication with others.||
1441|247|B|||
1441|248|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1441|249|D|remember. If it is near the time of the next dose, skip the||
1441|250|D|missed dose. Take your next dose at the regular time. Do not||
1441|251|D|double the dose to catch up.||
1441|252|B|||
1441|253|R|STORAGE:  Store at room temperature away from light and moisture.||
1441|254|R|Do not store in the bathroom. Keep all medications away from||
1441|255|R|children and pets.||
1441|256|R|   Do not flush medications down the toilet or pour them into a||
1441|257|R|drain unless instructed to do so. Properly discard this product||
1441|258|R|when it is expired or no longer needed. Consult your pharmacist||
1441|259|R|or local waste disposal company.||
1441|260|B|||
1441|261|A|Information last revised November 2025.||
1441|262|A|Copyright(c) 2025 First Databank, Inc.||
1441|263|B|||
1443|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1443|002|Z|does NOT have all possible information about this product. This||
1443|003|Z|information does not assure that this product is safe, effective,||
1443|004|Z|or appropriate for you. This information is not individual||
1443|005|Z|medical advice and does not substitute for the advice of your||
1443|006|Z|health care professional. Always ask your health care||
1443|007|Z|professional for complete information about this product and your||
1443|008|Z|specific health needs.||
1443|009|B|||
1443|010|T|APIXABAN - ORAL||
1443|011|F|(a-PIX-a-ban)||
1443|012|B|||
1443|013|C|COMMON BRAND NAME(S): Eliquis||
1443|014|B|||
1443|015|W|WARNING:  Do not stop taking apixaban unless directed by your||
1443|016|W|doctor. If you stop taking this medication early, you have a||
1443|017|W|higher risk of forming a serious blood clot (such as a stroke,||
1443|018|W|blood clot in the legs/lungs). Your doctor may direct you to take||
1443|019|W|a different "blood thinning" or antiplatelet medication to reduce||
1443|020|W|your risk. Get medical help right away if you have weakness on||
1443|021|W|one side of the body, trouble speaking, sudden vision changes,||
1443|022|W|confusion, chest pain, trouble breathing, or pain/warmth/swelling||
1443|023|W|in the legs.||
1443|024|W|   People taking this medication may bleed near the spinal cord||
1443|025|W|after certain spinal procedures. Bleeding in this area can cause||
1443|026|W|paralysis that lasts a long time or could become permanent.||
1443|027|W|Before any spinal procedure, ask your doctor about the benefits||
1443|028|W|and risks. The risk of bleeding may be higher if you have a||
1443|029|W|deformed spine, or have had spinal procedures/surgery before||
1443|030|W|(such as epidural catheter placement, difficult epidural/spinal||
1443|031|W|puncture), or are taking other drugs that can cause||
1443|032|W|bleeding/bruising (including antiplatelet drugs such as||
1443|033|W|clopidogrel, "blood thinners" such as warfarin/enoxaparin,||
1443|034|W|nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen).||
1443|035|W|Tell your doctor right away if you notice symptoms such as back||
1443|036|W|pain, leg numbness/tingling/weakness, loss of control of the||
1443|037|W|bowels or bladder (incontinence).||
1443|038|B|||
1443|039|U|USES:  Apixaban is used to prevent serious blood clots from||
1443|040|U|forming due to a certain irregular heartbeat (atrial||
1443|041|U|fibrillation) or after hip/knee replacement surgery. With atrial||
1443|042|U|fibrillation, part of the heart does not beat the way it should.||
1443|043|U|This can lead to blood clots forming, which can travel to other||
1443|044|U|parts of your body (such as the lungs or legs) or increase your||
1443|045|U|risk for stroke. In the United States, apixaban is also approved||
1443|046|U|to treat certain types of blood clots (deep vein thrombosis-DVT,||
1443|047|U|pulmonary embolus-PE) and to prevent them from forming again.||
1443|048|U|   Apixaban is an anticoagulant that works by blocking certain||
1443|049|U|clotting proteins in your blood.||
1443|050|B|||
1443|051|H|HOW TO USE:  See also Warning section.||
1443|052|H|   Read the Medication Guide and, if available, the Patient||
1443|053|H|Information Leaflet provided by your pharmacist before you start||
1443|054|H|taking apixaban and each time you get a refill. If you have any||
1443|055|H|questions, ask your doctor or pharmacist.||
1443|056|H|   Take this medication by mouth with or without food as directed||
1443|057|H|by your doctor, usually twice daily (every 12 hours). If you||
1443|058|H|cannot swallow the tablet whole, you may crush the tablet and mix||
1443|059|H|with water, apple juice, or applesauce and take it right away.||
1443|060|H|   The dosage is based on your medical condition, age, weight,||
1443|061|H|response to treatment, and other medications you may be taking.||
1443|062|H|Be sure to tell your doctor and pharmacist about all the products||
1443|063|H|you use (including prescription drugs, nonprescription drugs, and||
1443|064|H|herbal products). If you are taking apixaban to prevent blood||
1443|065|H|clots from forming after surgery, the length of treatment is||
1443|066|H|based on the type of surgery that you had.||
1443|067|H|   Do not stop taking this medication without consulting your||
1443|068|H|doctor. Some conditions may become worse when this drug is||
1443|069|H|suddenly stopped. Do not run out of this medication. Order your||
1443|070|H|refills early to avoid running out of pills.||
1443|071|H|   Use this medication regularly to get the most benefit from it.||
1443|072|H|To help you remember, take it at the same times each day.||
1443|073|B|||
1443|074|S|SIDE EFFECTS:  See also Warning section.||
1443|075|S|   Nausea, easy bruising, or minor bleeding (such as nosebleed,||
1443|076|S|bleeding from cuts) may occur. If any of these effects last or||
1443|077|S|get worse, tell your doctor or pharmacist promptly.||
1443|078|S|   Remember that this medication has been prescribed because your||
1443|079|S|doctor has judged that the benefit to you is greater than the||
1443|080|S|risk of side effects. Many people using this medication do not||
1443|081|S|have serious side effects.||
1443|082|S|   This medication can cause serious bleeding if it affects your||
1443|083|S|blood clotting proteins too much. Tell your doctor right away if||
1443|084|S|you have any signs of serious bleeding, including: nosebleeds||
1443|085|S|that happen often or don't stop, unusual tiredness/weakness,||
1443|086|S|unusual pain/swelling/discomfort, unusual bruising, prolonged||
1443|087|S|bleeding from cuts or gums, unusually heavy/prolonged menstrual||
1443|088|S|flow, pink/dark urine, coughing up blood, vomit that is bloody or||
1443|089|S|looks like coffee grounds, severe headache, dizziness/fainting,||
1443|090|S|bloody/black/tarry stools, difficulty swallowing.||
1443|091|S|   Get medical help right away if you have any signs of very||
1443|092|S|serious bleeding, including: vision changes, confusion, trouble||
1443|093|S|speaking, weakness on one side of the body.||
1443|094|S|   A very serious allergic reaction to this drug is rare.||
1443|095|S|However, get medical help right away if you notice any symptoms||
1443|096|S|of a serious allergic reaction, including: rash, itching/swelling||
1443|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1443|098|S|breathing.||
1443|099|S|   This is not a complete list of possible side effects. If you||
1443|100|S|notice other effects not listed above, contact your doctor or||
1443|101|S|pharmacist.||
1443|102|S|   In the US -||
1443|103|S|   Call your doctor for medical advice about side effects. You||
1443|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1443|105|S|www.fda.gov/medwatch.||
1443|106|S|   In Canada - Call your doctor for medical advice about side||
1443|107|S|effects. You may report side effects to Health Canada at||
1443|108|S|1-866-234-2345.||
1443|109|B|||
1443|110|P|PRECAUTIONS:  Before taking apixaban, tell your doctor or||
1443|111|P|pharmacist if you are allergic to it; or if you have any other||
1443|112|P|allergies. This product may contain inactive ingredients, which||
1443|113|P|can cause allergic reactions or other problems. Talk to your||
1443|114|P|pharmacist for more details.||
1443|115|P|   Before using this medication, tell your doctor or pharmacist||
1443|116|P|your medical history, especially of: liver disease, kidney||
1443|117|P|disease, bleeding problems (such as bleeding of the||
1443|118|P|stomach/intestines, bleeding in the brain), blood disorders (such||
1443|119|P|as anemia, hemophilia, thrombocytopenia), recent major||
1443|120|P|injury/surgery, stroke, a certain clotting disorder||
1443|121|P|(antiphospholipid syndrome), frequent falls/injuries.||
1443|122|P|   Before having surgery or any medical/dental procedures||
1443|123|P|(especially spinal puncture or spinal/epidural anesthesia), tell||
1443|124|P|your doctor or dentist that you are taking this medication and||
1443|125|P|about all the products you use (including prescription drugs,||
1443|126|P|nonprescription drugs, and herbal products). Your doctor or||
1443|127|P|dentist may tell you to stop taking apixaban before your surgery.||
1443|128|P|Ask for specific instructions about stopping or starting this||
1443|129|P|medication.||
1443|130|P|   This medication may cause stomach bleeding. Daily use of||
1443|131|P|alcohol while using this medicine will increase your risk for||
1443|132|P|stomach bleeding. Limit alcoholic beverages. Ask your doctor or||
1443|133|P|pharmacist about how much alcohol you may safely drink.||
1443|134|P|   This medication can cause heavy bleeding. To lower the chance||
1443|135|P|of getting cut, bruised, or injured, use caution with sharp||
1443|136|P|objects like razors and nail cutters, and avoid activities such||
1443|137|P|as contact sports. Use an electric razor when shaving and a soft||
1443|138|P|toothbrush when brushing your teeth. If you fall or injure||
1443|139|P|yourself, especially if you hit your head, call your doctor right||
1443|140|P|away. Your doctor may need to check you.||
1443|141|P|   During pregnancy, this medication should be used only when||
1443|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
1443|143|P|   It is unknown if this medication passes into breast milk.||
1443|144|P|Because of the possible risk to the infant, breastfeeding is not||
1443|145|P|recommended while using this medication. Consult your doctor||
1443|146|P|before breastfeeding.||
1443|147|B|||
1443|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1443|149|I|medications work or increase your risk for serious side effects.||
1443|150|I|This document does not contain all possible drug interactions.||
1443|151|I|Keep a list of all the products you use (including||
1443|152|I|prescription/nonprescription drugs and herbal products) and share||
1443|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
1443|154|I|the dosage of any medicines without your doctor's approval.||
1443|155|I|   Some products that may interact with this drug include:||
1443|156|I|mifepristone, other drugs that can cause bleeding/bruising||
1443|157|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
1443|158|I|ibuprofen/naproxen, "blood thinners" such as||
1443|159|I|warfarin/enoxaparin), certain antidepressants (including SSRIs||
1443|160|I|such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine).||
1443|161|I|   Other medications can affect the removal of apixaban from your||
1443|162|I|body, which may affect how apixaban works. Examples include||
1443|163|I|apalutamide, certain azole antifungals (such as itraconazole,||
1443|164|I|ketoconazole, posaconazole), conivaptan, HIV protease inhibitors||
1443|165|I|(such as lopinavir), rifamycins (such as rifabutin), ritonavir,||
1443|166|I|St. John's wort, drugs used to treat seizures (such as||
1443|167|I|carbamazepine, phenobarbital, phenytoin), among others.||
1443|168|I|   Aspirin can increase the risk of bleeding when used with this||
1443|169|I|medication. However, if your doctor has told you to take low-dose||
1443|170|I|aspirin to prevent heart attack or stroke (usually 81-162||
1443|171|I|milligrams a day), you should keep taking the aspirin unless your||
1443|172|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1443|173|I|details.||
1443|174|B|||
1443|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1443|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1443|177|O|poison control center right away. US residents can call||
1443|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1443|179|O|Symptoms of overdose may include: bloody/black/tarry stools,||
1443|180|O|pink/dark urine, unusual/prolonged bleeding.||
1443|181|B|||
1443|182|N|NOTES:  Do not share this medication with others.||
1443|183|N|   Lab and/or medical tests (such as hematocrit/hemoglobin, red||
1443|184|N|blood cell count) may be done while you are taking this||
1443|185|N|medication. Keep all medical and lab appointments. Consult your||
1443|186|N|doctor for more details.||
1443|187|B|||
1443|188|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
1443|189|D|if it is on the same day. Take your next dose at the regular||
1443|190|D|time. Do not double the dose to catch up.||
1443|191|B|||
1443|192|R|STORAGE:  Store at room temperature away from light and moisture.||
1443|193|R|Do not store in the bathroom. If you are crushing the tablet and||
1443|194|R|mixing it as directed in water, apple juice, or applesauce, use||
1443|195|R|the mixture within 4 hours of preparing it. Keep all medications||
1443|196|R|away from children and pets.||
1443|197|R|   Do not flush medications down the toilet or pour them into a||
1443|198|R|drain unless instructed to do so. Properly discard this product||
1443|199|R|when it is expired or no longer needed. Consult your pharmacist||
1443|200|R|or local waste disposal company.||
1443|201|B|||
1443|202|M|MEDICAL ALERT:  Your condition can cause complications in a||
1443|203|M|medical emergency. For information about enrolling in MedicAlert,||
1443|204|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1443|205|B|||
1443|206|A|Information last revised September 2025.||
1443|207|A|Copyright(c) 2025 First Databank, Inc.||
1443|208|B|||
1444|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1444|002|Z|does NOT have all possible information about this product. This||
1444|003|Z|information does not assure that this product is safe, effective,||
1444|004|Z|or appropriate for you. This information is not individual||
1444|005|Z|medical advice and does not substitute for the advice of your||
1444|006|Z|health care professional. Always ask your health care||
1444|007|Z|professional for complete information about this product and your||
1444|008|Z|specific health needs.||
1444|009|B|||
1444|010|T|INFLUENZA VIRUS VACCINE - INTRAMUSCULAR||
1444|011|F|(IN-floo-EN-za)||
1444|012|B|||
1444|013|C|COMMON BRAND NAME(S): Afluria, Flulaval, Fluvirin, Fluzone||
1444|014|B|||
1444|015|U|USES:  This vaccine is used to help prevent influenza ("flu") in||
1444|016|U|people 6 months and older. Influenza can cause serious (rarely||
1444|017|U|fatal) illness, especially in people at high risk from the||
1444|018|U|infection (such as young children, older adults, people with||
1444|019|U|chronic health problems). This vaccine is also called the||
1444|020|U|seasonal flu shot. It works by increasing the body's natural||
1444|021|U|defense (immunity) against the virus.||
1444|022|U|   Vaccination is the best way to protect against this infection.||
1444|023|U|It can help prevent the infection or decrease the seriousness of||
1444|024|U|the illness if you become infected. Since different types of flu||
1444|025|U|viruses cause infection every flu season, a new vaccine is made||
1444|026|U|and given every year.||
1444|027|U|   Vaccines may not fully protect everyone who receives them.||
1444|028|U|   The flu vaccine does not cause the flu.||
1444|029|B|||
1444|030|H|HOW TO USE:  Read all vaccine information available from your||
1444|031|H|health care professional before receiving the vaccine. If you||
1444|032|H|have any questions, ask your health care professional.||
1444|033|H|   This vaccine is given by injection into a muscle by a health||
1444|034|H|care professional. It is given in the upper arm for children and||
1444|035|H|adults and in the thigh for infants.||
1444|036|H|   The vaccination is usually given once a year during September||
1444|037|H|to November, the time when the number of flu cases begin to||
1444|038|H|increase (the start of "flu season"). Children younger than 9||
1444|039|H|years may receive a second dose depending on when the first dose||
1444|040|H|was given. Discuss the dose schedule with your health care||
1444|041|H|professional.||
1444|042|B|||
1444|043|S|SIDE EFFECTS:  Soreness/redness/swelling/bruising at the||
1444|044|S|injection site, fever, muscle aches, headache, or weakness may||
1444|045|S|occur. If any of these effects last or get worse, tell your||
1444|046|S|health care professional promptly.||
1444|047|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1444|048|S|vision changes, or ringing in the ears just after getting a||
1444|049|S|vaccine injection. Tell your health care professional right away||
1444|050|S|if you have any of these symptoms. Sitting or lying down may||
1444|051|S|help, since these symptoms usually don't last long.||
1444|052|S|   Remember that this vaccine has been prescribed because your||
1444|053|S|health care professional has judged that the benefit to you is||
1444|054|S|greater than the risk of side effects. Many people using this||
1444|055|S|vaccine do not have serious side effects.||
1444|056|S|   Tell your health care professional right away if you have any||
1444|057|S|serious side effects, including: mental/mood changes,||
1444|058|S|numbness/tingling, muscle weakness, seizures.||
1444|059|S|   A very serious allergic reaction to this vaccine is rare.||
1444|060|S|However, get medical help right away if you notice any symptoms||
1444|061|S|of a serious allergic reaction, including: rash, severe||
1444|062|S|dizziness, itching/swelling (especially of the||
1444|063|S|face/tongue/throat), trouble breathing.||
1444|064|S|   This is not a complete list of possible side effects. If you||
1444|065|S|notice other effects not listed above, contact your health care||
1444|066|S|professional.||
1444|067|S|   Contact the health care professional for medical advice about||
1444|068|S|side effects. The following numbers do not provide medical||
1444|069|S|advice, but in the US you may report side effects to the Vaccine||
1444|070|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1444|071|S|Canada, you may call the Vaccine Safety Section at Public Health||
1444|072|S|Agency of Canada at 1-866-844-0018.||
1444|073|B|||
1444|074|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
1444|075|P|care professional if you are allergic to it; or if you have any||
1444|076|P|other allergies. This product may contain inactive ingredients||
1444|077|P|(such as latex found in some brands, preservatives like||
1444|078|P|thimerosal), which can cause allergic reactions or other||
1444|079|P|problems. Talk to your health care professional for more details.||
1444|080|P|   Before receiving this vaccine, tell your health care||
1444|081|P|professional your medical history, especially of: current||
1444|082|P|fever/illness, nervous system disorders (such as seizures,||
1444|083|P|encephalopathy, Guillain-Barre syndrome), immune system disorders||
1444|084|P|(such as due to HIV infection, certain cancers such as||
1444|085|P|leukemia/lymphoma, cancer or radiation treatment), vaccination||
1444|086|P|history (including previous reactions to any vaccines).||
1444|087|P|   During pregnancy, flu vaccination is usually recommended.||
1444|088|P|Discuss the risks and benefits with your health care||
1444|089|P|professional.||
1444|090|P|   It is unknown if this vaccine passes into breast milk. Consult||
1444|091|P|your health care professional before breastfeeding.||
1444|092|B|||
1444|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1444|094|I|medications work or increase your risk for serious side effects.||
1444|095|I|This document does not contain all possible drug interactions.||
1444|096|I|Keep a list of all the products you use (including||
1444|097|I|prescription/nonprescription drugs and herbal products) and share||
1444|098|I|it with your health care professional. Do not start, stop, or||
1444|099|I|change the dosage of any medicines without your doctor's||
1444|100|I|approval.||
1444|101|B|||
1444|102|O|OVERDOSE:  Not applicable.||
1444|103|B|||
1444|104|N|NOTES:  Keep all medical and lab appointments.||
1444|105|N|   Keep vaccine records for yourself and your children and||
1444|106|N|provide them to the health care professionals to prevent||
1444|107|N|unnecessary re-vaccinations.||
1444|108|B|||
1444|109|D|MISSED DOSE:  This vaccine is usually given once every flu||
1444|110|D|season. If your child is prescribed a second dose, mark your||
1444|111|D|calendar with a reminder. If your child misses the dose, call the||
1444|112|D|health care professional to reschedule.||
1444|113|B|||
1444|114|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
1444|115|R|light. Keep all medications away from children and pets.||
1444|116|R|   Do not flush medications down the toilet or pour them into a||
1444|117|R|drain unless instructed to do so. Properly discard this product||
1444|118|R|when it is expired or no longer needed. Consult your pharmacist||
1444|119|R|or local waste disposal company.||
1444|120|B|||
1444|121|A|Information last revised February 2025.||
1444|122|A|Copyright(c) 2025 First Databank, Inc.||
1444|123|B|||
1447|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1447|002|Z|does NOT have all possible information about this product. This||
1447|003|Z|information does not assure that this product is safe, effective,||
1447|004|Z|or appropriate for you. This information is not individual||
1447|005|Z|medical advice and does not substitute for the advice of your||
1447|006|Z|health care professional. Always ask your health care||
1447|007|Z|professional for complete information about this product and your||
1447|008|Z|specific health needs.||
1447|009|B|||
1447|010|T|CRIZOTINIB - ORAL||
1447|011|F|(kriz-OH-ti-nib)||
1447|012|B|||
1447|013|C|COMMON BRAND NAME(S): Xalkori||
1447|014|B|||
1447|015|U|USES:  Crizotinib is used to treat certain types of cancer (such||
1447|016|U|as lung cancer, anaplastic large cell lymphoma-ALCL). It is also||
1447|017|U|used to treat a certain type of tumor (inflammatory||
1447|018|U|myofibroblastic tumor-IMT). Crizotinib works by slowing or||
1447|019|U|stopping the growth of cancer or tumor cells. It belongs to a||
1447|020|U|class of drugs known as kinase inhibitors.||
1447|021|B|||
1447|022|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1447|023|H|Instructions for Use provided by your pharmacist before you start||
1447|024|H|taking crizotinib and each time you get a refill. If you have any||
1447|025|H|questions, ask your doctor or pharmacist.||
1447|026|H|   Take this medication by mouth with or without food as directed||
1447|027|H|by your doctor, usually once or twice daily. This medication||
1447|028|H|comes in 2 dosage forms: a capsule to swallow or a capsule that||
1447|029|H|must be opened that contains pellets.||
1447|030|H|   If you are using the capsules to swallow, swallow the||
1447|031|H|capsule(s) whole. Do not chew, crush, or split the capsules.||
1447|032|H|   If you are using the capsules that contain pellets, do not||
1447|033|H|swallow the capsule(s) whole. You must first open the capsule(s),||
1447|034|H|then directly pour or spoon all of the pellets into your mouth.||
1447|035|H|Do not chew or crush the pellets before swallowing. Drink water||
1447|036|H|after taking to make sure the entire dose is taken. Repeat these||
1447|037|H|steps if the dose is for more than one capsule. Throw away the||
1447|038|H|empty capsule shell(s) in the trash.||
1447|039|H|   If you vomit after taking your dose of the medication, do not||
1447|040|H|take an extra dose. Take the next dose of your medication at the||
1447|041|H|regular time.||
1447|042|H|   The dosage is based on your medical condition, lab tests,||
1447|043|H|response to treatment, and other medications you may be taking.||
1447|044|H|Children's dosage is also based on body size. Be sure to tell||
1447|045|H|your doctor and pharmacist about all the products you use||
1447|046|H|(including prescription drugs, nonprescription drugs, and herbal||
1447|047|H|products).||
1447|048|H|   To decrease the risk of side effects, your doctor may||
1447|049|H|prescribe other medications to take along with this medication.||
1447|050|H|Carefully follow your doctor's directions for all your||
1447|051|H|medications.||
1447|052|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1447|053|H|using this medication unless your doctor or pharmacist says you||
1447|054|H|may do so safely. Grapefruit can increase the chance of side||
1447|055|H|effects with this medicine. Ask your doctor or pharmacist for||
1447|056|H|more details.||
1447|057|H|   Do not increase your dose or use this drug more often or for||
1447|058|H|longer than prescribed. Your condition will not improve any||
1447|059|H|faster, and your risk of side effects will increase.||
1447|060|H|   Use this medication regularly to get the most benefit from it.||
1447|061|H|To help you remember, use it at the same time(s) each day.||
1447|062|H|   Since this drug can be absorbed through the skin and lungs and||
1447|063|H|may harm an unborn baby, women who are pregnant or who may become||
1447|064|H|pregnant should not handle this medication or breathe the dust||
1447|065|H|from the capsules.||
1447|066|B|||
1447|067|S|SIDE EFFECTS:  Nausea, diarrhea, vomiting, dizziness, tiredness,||
1447|068|S|headache, heartburn, change in taste, loss of appetite, mouth||
1447|069|S|sores, joint pain, trouble sleeping, or constipation may occur.||
1447|070|S|If any of these effects last or get worse, tell your doctor or||
1447|071|S|pharmacist promptly.||
1447|072|S|   Remember that this medication has been prescribed because your||
1447|073|S|doctor has judged that the benefit to you is greater than the||
1447|074|S|risk of side effects. Many people using this medication do not||
1447|075|S|have serious side effects.||
1447|076|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
1447|077|S|Contact your doctor promptly if you notice any symptoms of||
1447|078|S|dehydration, such as unusual decreased urination, or unusual dry||
1447|079|S|mouth/thirst.||
1447|080|S|   This medication may lower your ability to fight infections.||
1447|081|S|This may make you more likely to get a serious infection or make||
1447|082|S|any infection you have worse. Tell your doctor right away if you||
1447|083|S|have any signs of infection (such as sore throat that doesn't go||
1447|084|S|away, fever, chills).||
1447|085|S|   Tell your doctor right away if you have any serious side||
1447|086|S|effects, including: vision changes (such as decreased/blurry||
1447|087|S|vision, seeing flashes of light/floaters, sensitivity to light),||
1447|088|S|swelling of the legs/feet/hands, easy bleeding/bruising.||
1447|089|S|   Although crizotinib is used to treat certain types of lung||
1447|090|S|cancers, it may rarely cause other serious (possibly fatal) lung||
1447|091|S|problems. Tell your doctor right away if you have any new or||
1447|092|S|worsening shortness of breath or cough.||
1447|093|S|   Crizotinib has rarely caused very serious (possibly fatal)||
1447|094|S|liver disease. Tell your doctor right away if you develop||
1447|095|S|symptoms of liver disease, such as nausea/vomiting that doesn't||
1447|096|S|stop, stomach/abdominal pain, yellowing eyes/skin, dark urine.||
1447|097|S|   Get medical help right away if you have any very serious side||
1447|098|S|effects, including: fast/slow/irregular heartbeat, severe||
1447|099|S|dizziness, fainting.||
1447|100|S|   A very serious allergic reaction to this drug is rare.||
1447|101|S|However, get medical help right away if you notice any symptoms||
1447|102|S|of a serious allergic reaction, including: rash, itching/swelling||
1447|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1447|104|S|breathing.||
1447|105|S|   Crizotinib can commonly cause a rash that is usually not||
1447|106|S|serious. However, you may not be able to tell it apart from a||
1447|107|S|rare rash that could be a sign of a severe reaction. Tell your||
1447|108|S|doctor right away if you develop any rash.||
1447|109|S|   This is not a complete list of possible side effects. If you||
1447|110|S|notice other effects not listed above, contact your doctor or||
1447|111|S|pharmacist.||
1447|112|S|   In the US -||
1447|113|S|   Call your doctor for medical advice about side effects. You||
1447|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1447|115|S|www.fda.gov/medwatch.||
1447|116|S|   In Canada - Call your doctor for medical advice about side||
1447|117|S|effects. You may report side effects to Health Canada at||
1447|118|S|1-866-234-2345.||
1447|119|B|||
1447|120|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1447|121|P|pharmacist if you are allergic to it; or if you have any other||
1447|122|P|allergies. This product may contain inactive ingredients, which||
1447|123|P|can cause allergic reactions or other problems. Talk to your||
1447|124|P|pharmacist for more details.||
1447|125|P|   Before using this medication, tell your doctor or pharmacist||
1447|126|P|your medical history, especially of: kidney problems, liver||
1447|127|P|problems.||
1447|128|P|   Crizotinib may cause a condition that affects the heart rhythm||
1447|129|P|(QT prolongation). QT prolongation can rarely cause serious||
1447|130|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1447|131|P|as severe dizziness, fainting) that need medical attention right||
1447|132|P|away.||
1447|133|P|   The risk of QT prolongation may be increased if you have||
1447|134|P|certain medical conditions or are taking other drugs that may||
1447|135|P|cause QT prolongation. Before using crizotinib, tell your doctor||
1447|136|P|or pharmacist of all the drugs you take and if you have any of||
1447|137|P|the following conditions: certain heart problems (heart failure,||
1447|138|P|slow heartbeat, QT prolongation in the EKG), family history of||
1447|139|P|certain heart problems (QT prolongation in the EKG, sudden||
1447|140|P|cardiac death).||
1447|141|P|   Low levels of potassium or magnesium in the blood may also||
1447|142|P|increase your risk of QT prolongation. This risk may increase if||
1447|143|P|you use certain drugs (such as diuretics/"water pills") or if you||
1447|144|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1447|145|P|Talk to your doctor about using crizotinib safely.||
1447|146|P|   Crizotinib can make you more likely to get infections or may||
1447|147|P|make current infections worse. Stay away from anyone who has an||
1447|148|P|infection that may easily spread (such as chickenpox, COVID-19,||
1447|149|P|measles, flu). Talk to your doctor if you have been exposed to an||
1447|150|P|infection or for more details.||
1447|151|P|   Tell your health care professional that you are using||
1447|152|P|crizotinib before having any immunizations/vaccinations. Avoid||
1447|153|P|contact with people who have recently received live vaccines||
1447|154|P|(such as flu vaccine inhaled through the nose).||
1447|155|P|   This drug may make you dizzy or cause vision changes. Alcohol||
1447|156|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
1447|157|P|use machinery, or do anything that needs alertness or clear||
1447|158|P|vision until you can do it safely. Limit alcoholic beverages.||
1447|159|P|Talk to your doctor if you are using marijuana (cannabis).||
1447|160|P|   This medication may make you more sensitive to the sun. Limit||
1447|161|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1447|162|P|sunscreen and wear protective clothing when outdoors. Tell your||
1447|163|P|doctor right away if you get sunburned or have skin||
1447|164|P|blisters/redness.||
1447|165|P|   Before having surgery, tell your doctor or dentist about all||
1447|166|P|the products you use (including prescription drugs,||
1447|167|P|nonprescription drugs, and herbal products).||
1447|168|P|   Older adults may be more sensitive to the side effects of this||
1447|169|P|drug, especially QT prolongation (see above).||
1447|170|P|   Since this drug can be absorbed through the skin and lungs and||
1447|171|P|may harm an unborn baby, women who are pregnant or who may become||
1447|172|P|pregnant should not handle this medication or breathe the dust||
1447|173|P|from the capsules.||
1447|174|P|   Tell your doctor if you are pregnant or plan to become||
1447|175|P|pregnant. You should not become pregnant while using crizotinib.||
1447|176|P|Crizotinib may harm an unborn baby. Your doctor should order a||
1447|177|P|pregnancy test before you start this medication. Women using this||
1447|178|P|medication should ask about reliable forms of birth control||
1447|179|P|during treatment and for some time after the last dose. Men using||
1447|180|P|this medication should ask about reliable forms of birth control||
1447|181|P|during treatment and for 90 days after the last dose. If you or||
1447|182|P|your partner becomes pregnant, talk to your doctor right away||
1447|183|P|about the risks and benefits of this medication.||
1447|184|P|   It is unknown if this medication passes into breast milk.||
1447|185|P|Because of the possible risk to the infant, breastfeeding is not||
1447|186|P|recommended while using this medication and for 45 days after the||
1447|187|P|last dose. Consult your doctor before breastfeeding.||
1447|188|B|||
1447|189|I|DRUG INTERACTIONS:  See also How to Use section.||
1447|190|I|   Drug interactions may change how your medications work or||
1447|191|I|increase your risk for serious side effects. This document does||
1447|192|I|not contain all possible drug interactions. Keep a list of all||
1447|193|I|the products you use (including prescription/nonprescription||
1447|194|I|drugs and herbal products) and share it with your doctor and||
1447|195|I|pharmacist. Do not start, stop, or change the dosage of any||
1447|196|I|medicines without your doctor's approval.||
1447|197|I|   Some products that may interact with this drug include: drugs||
1447|198|I|that may slow the heartbeat (including digoxin, clonidine,||
1447|199|I|beta-blockers such as atenolol/metoprolol, calcium channel||
1447|200|I|blockers such as diltiazem/verapamil).||
1447|201|I|   Other medications can affect the removal of crizotinib from||
1447|202|I|your body, which may affect how crizotinib works. Examples||
1447|203|I|include azole antifungals (such as itraconazole), macrolide||
1447|204|I|antibiotics (such as erythromycin), rifamycins (such as||
1447|205|I|rifabutin), drugs for seizures (such as carbamazepine,||
1447|206|I|phenytoin), St. John's wort, among others.||
1447|207|I|   This medication can slow down the removal of other medications||
1447|208|I|from your body, which may affect how they work. Examples of||
1447|209|I|affected drugs include alfentanil, elacestrant, ergots (such as||
1447|210|I|ergotamine), fentanyl, flibanserin, lomitapide, lonafarnib,||
1447|211|I|tacrolimus, among others.||
1447|212|I|   Many drugs besides crizotinib may affect the heart rhythm (QT||
1447|213|I|prolongation), including amiodarone, dofetilide, quinidine,||
1447|214|I|procainamide, sotalol, and certain antipsychotic medications||
1447|215|I|(such as pimozide, thioridazine, ziprasidone), among others.||
1447|216|B|||
1447|217|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1447|218|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1447|219|O|poison control center right away. US residents can call||
1447|220|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1447|221|B|||
1447|222|N|NOTES:  Do not share this medication with others.||
1447|223|N|   Lab and/or medical tests (such as liver/kidney function, EKG,||
1447|224|N|complete blood counts, eye exams, blood pressure, heart rate)||
1447|225|N|will be done before you start taking this medication and while||
1447|226|N|you are taking it. Keep all medical and lab appointments. Consult||
1447|227|N|your doctor for more details.||
1447|228|B|||
1447|229|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1447|230|D|remember. If it is less than 6 hours before the next dose, skip||
1447|231|D|the missed dose. Take your next dose at the regular time. Do not||
1447|232|D|double the dose to catch up.||
1447|233|B|||
1447|234|R|STORAGE:  Store at room temperature away from light and moisture.||
1447|235|R|Do not store in the bathroom. Keep all medications away from||
1447|236|R|children and pets.||
1447|237|R|   Do not flush medications down the toilet or pour them into a||
1447|238|R|drain unless instructed to do so. Properly discard this product||
1447|239|R|when it is expired or no longer needed. Consult your pharmacist||
1447|240|R|or local waste disposal company.||
1447|241|B|||
1447|242|A|Information last revised March 2025.||
1447|243|A|Copyright(c) 2025 First Databank, Inc.||
1447|244|B|||
1448|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1448|002|Z|does NOT have all possible information about this product. This||
1448|003|Z|information does not assure that this product is safe, effective,||
1448|004|Z|or appropriate for you. This information is not individual||
1448|005|Z|medical advice and does not substitute for the advice of your||
1448|006|Z|health care professional. Always ask your health care||
1448|007|Z|professional for complete information about this product and your||
1448|008|Z|specific health needs.||
1448|009|B|||
1448|010|T|IBUPROFEN/FAMOTIDINE - ORAL||
1448|011|F|(EYE-bue-PROE-fen/fam-OH-ti-deen)||
1448|012|B|||
1448|013|C|COMMON BRAND NAME(S): Duexis||
1448|014|B|||
1448|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1448|016|W|ibuprofen) may rarely increase the risk of a heart attack or||
1448|017|W|stroke. This effect can happen at any time while taking this drug||
1448|018|W|but is more likely if you take it for a long time. The risk may||
1448|019|W|be greater in older adults or if you have heart disease or an||
1448|020|W|increased risk for heart disease (for example, due to smoking,||
1448|021|W|family history of heart disease, or conditions such as high blood||
1448|022|W|pressure or diabetes). Do not take this drug right before or||
1448|023|W|after heart bypass surgery (CABG).||
1448|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
1448|025|W|from the stomach or intestines. This effect can occur without||
1448|026|W|warning at any time while taking this drug. Older adults may be||
1448|027|W|at higher risk for this effect.||
1448|028|W|   Stop taking this product and get medical help right away if||
1448|029|W|you notice any of these rare but serious side effects:||
1448|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
1448|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1448|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
1448|033|W|side of the body, trouble speaking, sudden vision changes.||
1448|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
1448|035|W|of taking this drug.||
1448|036|B|||
1448|037|U|USES:  This combination medication is used to relieve pain from||
1448|038|U|rheumatoid arthritis and osteoarthritis while decreasing the risk||
1448|039|U|of developing an ulcer from ibuprofen use. It contains ibuprofen||
1448|040|U|and famotidine. Ibuprofen is a nonsteroidal anti-inflammatory||
1448|041|U|drug (NSAID) that works by blocking your body's production of||
1448|042|U|certain natural substances that cause inflammation. This helps to||
1448|043|U|decrease swelling and pain. Famotidine is an H2 blocker that||
1448|044|U|works by reducing the amount of acid in your stomach. This helps||
1448|045|U|prevent ulcers.||
1448|046|U|   Ask your doctor about non-drug treatments and/or using other||
1448|047|U|medications to treat your pain. See also Warning section.||
1448|048|B|||
1448|049|V|OTHER USES:  This section contains uses of this drug that are not||
1448|050|V|listed in the approved professional labeling for the drug but||
1448|051|V|that may be prescribed by your health care professional. Use this||
1448|052|V|drug for a condition that is listed in this section only if it||
1448|053|V|has been so prescribed by your health care professional.||
1448|054|V|   This drug may also be used for gout attacks.||
1448|055|B|||
1448|056|H|HOW TO USE:  Read the Medication Guide provided by your||
1448|057|H|pharmacist before you start taking ibuprofen/famotidine and each||
1448|058|H|time you get a refill. If you have any questions, ask your doctor||
1448|059|H|or pharmacist.||
1448|060|H|   Take this medication by mouth as directed by your doctor,||
1448|061|H|usually three times a day. Take it with a full glass of water (8||
1448|062|H|ounces/240 milliliters). Do not lie down for at least 10 minutes||
1448|063|H|after taking this drug. If you have stomach upset while taking||
1448|064|H|this medication, take it with food, milk, or an antacid.||
1448|065|H|   Swallow whole. Do not chew, crush, or split the medication.||
1448|066|H|Splitting the medication may not provide enough famotidine to||
1448|067|H|protect against ulcers.||
1448|068|H|   The dosage is based on your medical condition and response to||
1448|069|H|treatment. To reduce your risk of stomach bleeding and other side||
1448|070|H|effects, take this medication at the lowest effective dose for||
1448|071|H|the shortest possible time. Do not increase your dose or take||
1448|072|H|this drug more often than prescribed.||
1448|073|H|   It may take up to two weeks of taking this drug regularly||
1448|074|H|until you get the full benefit.||
1448|075|H|   Take this medication regularly to get the most benefit from||
1448|076|H|it. To help you remember, take it at the same times each day.||
1448|077|H|   Tell your doctor if your condition lasts or gets worse.||
1448|078|B|||
1448|079|S|SIDE EFFECTS:  See also Warning section.||
1448|080|S|   Upset stomach, nausea, vomiting, headache, diarrhea,||
1448|081|S|constipation, dizziness, or drowsiness may occur. If any of these||
1448|082|S|effects last or get worse, tell your doctor or pharmacist||
1448|083|S|promptly.||
1448|084|S|   If your doctor has prescribed this medication, remember that||
1448|085|S|your doctor has judged that the benefit to you is greater than||
1448|086|S|the risk of side effects. Many people using this medication do||
1448|087|S|not have serious side effects.||
1448|088|S|   This medication may raise your blood pressure. Check your||
1448|089|S|blood pressure regularly and tell your doctor if the results are||
1448|090|S|high.||
1448|091|S|   Tell your doctor right away if you have any serious side||
1448|092|S|effects, including: easy bruising/bleeding, hearing changes (such||
1448|093|S|as ringing in the ears), mental/mood changes, unexplained stiff||
1448|094|S|neck, signs of kidney problems (such as change in the amount of||
1448|095|S|urine), vision changes, symptoms of heart failure (such as||
1448|096|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
1448|097|S|gain).||
1448|098|S|   This drug may rarely cause serious (possibly fatal) liver||
1448|099|S|disease. Get medical help right away if you have any symptoms of||
1448|100|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1448|101|S|of appetite, stomach/abdominal pain, dark urine, yellowing||
1448|102|S|eyes/skin.||
1448|103|S|   Get medical help right away if you have any very serious side||
1448|104|S|effects, including: fast/slow/irregular heartbeat, severe||
1448|105|S|dizziness, fainting, seizure.||
1448|106|S|   A very serious allergic reaction to this drug is rare.||
1448|107|S|However, get medical help right away if you notice any symptoms||
1448|108|S|of a serious allergic reaction, including: fever, swollen lymph||
1448|109|S|nodes, rash, itching/swelling (especially of the||
1448|110|S|face/tongue/throat), severe dizziness, trouble breathing.||
1448|111|S|   This is not a complete list of possible side effects. If you||
1448|112|S|notice other effects not listed above, contact your doctor or||
1448|113|S|pharmacist.||
1448|114|S|   In the US -||
1448|115|S|   Call your doctor for medical advice about side effects. You||
1448|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1448|117|S|www.fda.gov/medwatch.||
1448|118|S|   In Canada - Call your doctor for medical advice about side||
1448|119|S|effects. You may report side effects to Health Canada at||
1448|120|S|1-866-234-2345.||
1448|121|B|||
1448|122|P|PRECAUTIONS:  Before taking ibuprofen/famotidine, tell your||
1448|123|P|doctor or pharmacist if you are allergic to it; or to aspirin or||
1448|124|P|other NSAIDs (such as naproxen, celecoxib); or to other H2||
1448|125|P|blockers (such as cimetidine, ranitidine) or if you have any||
1448|126|P|other allergies. This product may contain inactive ingredients,||
1448|127|P|which can cause allergic reactions or other problems. Talk to||
1448|128|P|your pharmacist for more details.||
1448|129|P|   Before taking this medication, tell your doctor or pharmacist||
1448|130|P|your medical history, especially of: asthma (including a history||
1448|131|P|of worsening breathing after taking aspirin or other NSAIDs),||
1448|132|P|blood disorders (such as anemia, bleeding/clotting problems),||
1448|133|P|growths in the nose (nasal polyps), heart disease (such as||
1448|134|P|previous heart attack), high blood pressure, liver disease,||
1448|135|P|stroke, throat/stomach/intestinal problems (such as bleeding,||
1448|136|P|heartburn, ulcers).||
1448|137|P|   Kidney problems can sometimes occur with the use of NSAID||
1448|138|P|medications, including ibuprofen. Problems are more likely to||
1448|139|P|occur if you are dehydrated, have heart failure or kidney||
1448|140|P|disease, are an older adult, or if you take certain medications||
1448|141|P|(see also Drug Interactions section). Drink plenty of fluids as||
1448|142|P|directed by your doctor to prevent dehydration and tell your||
1448|143|P|doctor right away if you have a change in the amount of urine.||
1448|144|P|   This drug may make you dizzy or drowsy or blur your vision.||
1448|145|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1448|146|P|drowsy. Do not drive, use machinery, or do anything that needs||
1448|147|P|alertness or clear vision until you can do it safely. Limit||
1448|148|P|alcoholic beverages. Talk to your doctor if you are using||
1448|149|P|marijuana (cannabis).||
1448|150|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1448|151|P|and tobacco, especially when combined with this medicine, may||
1448|152|P|increase your risk for stomach bleeding. Limit alcohol and stop||
1448|153|P|smoking. Consult your doctor or pharmacist for more information.||
1448|154|P|   This medication may make you more sensitive to the sun. Limit||
1448|155|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1448|156|P|sunscreen and wear protective clothing when outdoors. Tell your||
1448|157|P|doctor right away if you get sunburned or have skin||
1448|158|P|blisters/redness.||
1448|159|P|   Before having surgery, tell your doctor or dentist about all||
1448|160|P|the products you use (including prescription drugs,||
1448|161|P|nonprescription drugs, and herbal products).||
1448|162|P|   Older adults may be at greater risk for stomach/intestinal||
1448|163|P|bleeding, kidney problems, heart attack, stroke, mental/mood||
1448|164|P|changes (such as confusion), seizure, or unusual tiredness while||
1448|165|P|using this drug.||
1448|166|P|   Before using this medication, women of childbearing age should||
1448|167|P|talk with their doctor(s) about the benefits and risks. Tell your||
1448|168|P|doctor if you are pregnant or if you plan to become pregnant.||
1448|169|P|This medication may harm an unborn baby and cause problems with||
1448|170|P|normal labor/delivery. It is not recommended for use in pregnancy||
1448|171|P|from 20 weeks until delivery. If your doctor decides that you||
1448|172|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1448|173|P|you should use the lowest effective dose for the shortest||
1448|174|P|possible time. You should not use this medication after 30 weeks||
1448|175|P|of pregnancy.||
1448|176|P|   This medication passes into breast milk, but is unlikely to||
1448|177|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1448|178|B|||
1448|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1448|180|I|medications work or increase your risk for serious side effects.||
1448|181|I|This document does not contain all possible drug interactions.||
1448|182|I|Keep a list of all the products you use (including||
1448|183|I|prescription/nonprescription drugs and herbal products) and share||
1448|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
1448|185|I|the dosage of any medicines without your doctor's approval.||
1448|186|I|   Some products that may interact with this drug include:||
1448|187|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1448|188|I|angiotensin II receptor blockers (such as valsartan, losartan),||
1448|189|I|cidofovir, fezolinetant, lithium, corticosteroids (such as||
1448|190|I|prednisone), "water pills" (diuretics such as furosemide).||
1448|191|I|   This medication may increase the risk of bleeding when taken||
1448|192|I|with other drugs that also may cause bleeding. Examples include||
1448|193|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1448|194|I|dabigatran/enoxaparin/warfarin, among others.||
1448|195|I|   Check all prescription and nonprescription medicine labels||
1448|196|I|carefully since many medications contain pain relievers/fever||
1448|197|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
1448|198|I|or naproxen). These drugs are similar to ibuprofen and may||
1448|199|I|increase your risk of side effects if taken together. However, if||
1448|200|I|your doctor has told you to take low-dose aspirin to prevent||
1448|201|I|heart attack or stroke (usually 81-162 milligrams a day), you||
1448|202|I|should keep taking the aspirin unless your doctor tells you not||
1448|203|I|to. Daily use of ibuprofen may decrease aspirin's ability to||
1448|204|I|prevent heart attack/stroke. Talk to your doctor about using a||
1448|205|I|different medication (such as acetaminophen) to treat pain/fever.||
1448|206|I|If you must take ibuprofen, talk to your doctor about taking||
1448|207|I|immediate-release aspirin (not enteric-coated/EC) while taking||
1448|208|I|ibuprofen. Take ibuprofen at least 8 hours before or at least 2||
1448|209|I|hours after your aspirin dose. Do not increase your daily dose of||
1448|210|I|aspirin or change the way you take aspirin/other medications||
1448|211|I|without your doctor's approval.||
1448|212|I|   Some products need stomach acid so that the body can absorb||
1448|213|I|them properly. Famotidine decreases stomach acid, so it may||
1448|214|I|change how well these products work. Some affected products||
1448|215|I|include atazanavir, dasatinib, certain azole antifungals (such as||
1448|216|I|itraconazole, ketoconazole), levoketoconazole, pazopanib,||
1448|217|I|sparsentan, among others.||
1448|218|B|||
1448|219|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1448|220|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1448|221|O|poison control center right away. US residents can call||
1448|222|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1448|223|O|Symptoms of overdose may include: severe stomach pain, trouble||
1448|224|O|breathing, extreme drowsiness.||
1448|225|B|||
1448|226|N|NOTES:  Do not share this medication with others.||
1448|227|N|   Lab and/or medical tests (such as blood pressure, complete||
1448|228|N|blood counts, liver/kidney function) may be done while you are||
1448|229|N|taking this medication. Keep all medical and lab appointments.||
1448|230|N|Consult your doctor for more details.||
1448|231|N|   Non-drug treatment for arthritis that is approved by your||
1448|232|N|doctor (such as weight loss if needed, strengthening and||
1448|233|N|conditioning exercises) may help improve your flexibility, range||
1448|234|N|of motion, and joint function. Consult your doctor for specific||
1448|235|N|instructions.||
1448|236|B|||
1448|237|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1448|238|D|remember. If it is near the time of the next dose, skip the||
1448|239|D|missed dose. Take your next dose at the regular time. Do not||
1448|240|D|double the dose to catch up.||
1448|241|B|||
1448|242|R|STORAGE:  Store at room temperature away from light and moisture.||
1448|243|R|Do not store in the bathroom. Keep all medications away from||
1448|244|R|children and pets.||
1448|245|R|   Do not flush medications down the toilet or pour them into a||
1448|246|R|drain unless instructed to do so. Properly discard this product||
1448|247|R|when it is expired or no longer needed. Consult your pharmacist||
1448|248|R|or local waste disposal company.||
1448|249|B|||
1448|250|A|Information last revised May 2024.||
1448|251|A|Copyright(c) 2025 First Databank, Inc.||
1448|252|B|||
1449|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1449|002|Z|does NOT have all possible information about this product. This||
1449|003|Z|information does not assure that this product is safe, effective,||
1449|004|Z|or appropriate for you. This information is not individual||
1449|005|Z|medical advice and does not substitute for the advice of your||
1449|006|Z|health care professional. Always ask your health care||
1449|007|Z|professional for complete information about this product and your||
1449|008|Z|specific health needs.||
1449|009|B|||
1449|010|T|MIFEPRISTONE 300 MG - ORAL||
1449|011|F|(MIF-e-PRIS-tone)||
1449|012|B|||
1449|013|C|COMMON BRAND NAME(S): Korlym||
1449|014|B|||
1449|015|W|WARNING:  Mifepristone may cause a loss of pregnancy. Before||
1449|016|W|starting this medication, women of childbearing age must get a||
1449|017|W|pregnancy test to confirm that they are not pregnant. Women must||
1449|018|W|avoid becoming pregnant while taking this medication and for one||
1449|019|W|month after stopping this medication. Consult your doctor for||
1449|020|W|more details and to discuss using a reliable form of non-hormonal||
1449|021|W|birth control (such as condoms, diaphragm with spermicide). If||
1449|022|W|you become pregnant or think you may be pregnant, tell your||
1449|023|W|doctor right away. If this medication is stopped for more than 14||
1449|024|W|days, women of childbearing age must get another pregnancy test||
1449|025|W|to confirm that they are not pregnant before restarting the||
1449|026|W|medication.||
1449|027|B|||
1449|028|U|USES:  This medication is used to control high blood sugar in||
1449|029|U|people who have a certain condition (Cushing's syndrome), and who||
1449|030|U|have failed surgery or cannot have surgery to correct the||
1449|031|U|condition. Cushing's syndrome is caused by the body producing too||
1449|032|U|much of a certain hormone (cortisol) which can cause glucose||
1449|033|U|intolerance or type 2 diabetes. Mifepristone works by blocking||
1449|034|U|the effects of cortisol.||
1449|035|B|||
1449|036|H|HOW TO USE:  Read the Medication Guide provided by your||
1449|037|H|pharmacist before you start taking mifepristone and each time you||
1449|038|H|get a refill. If you have any questions, ask your doctor or||
1449|039|H|pharmacist.||
1449|040|H|   Take this medication by mouth with a meal as directed by your||
1449|041|H|doctor, usually once daily. Swallow the tablets whole. Do not||
1449|042|H|crush, chew, or split the tablets.||
1449|043|H|   The dosage is based on your medical condition, response to||
1449|044|H|treatment, and other medications you may be taking. Be sure to||
1449|045|H|tell your doctor and pharmacist about all the products you use||
1449|046|H|(including prescription drugs, nonprescription drugs, and herbal||
1449|047|H|products). To reduce your risk of side effects, your doctor may||
1449|048|H|direct you to start this medication at a low dose and gradually||
1449|049|H|increase your dose. Follow your doctor's instructions carefully.||
1449|050|H|   Use this medication regularly to get the most benefit from it.||
1449|051|H|To help you remember, take it at the same time each day.||
1449|052|H|   Do not stop taking this medicine unless instructed by your||
1449|053|H|doctor. If this medication is stopped, you may need to restart at||
1449|054|H|a lower dose and gradually increase the dose again. Consult your||
1449|055|H|doctor or pharmacist for instructions on restarting your||
1449|056|H|medication if you have not taken it for several days.||
1449|057|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1449|058|H|using this medication unless your doctor or pharmacist says you||
1449|059|H|may do so safely. Grapefruit can increase the chance of side||
1449|060|H|effects with this medicine. Ask your doctor or pharmacist for||
1449|061|H|more details.||
1449|062|H|   Tell your doctor if your condition lasts or gets worse.||
1449|063|H|   Since this drug can be absorbed through the skin and may harm||
1449|064|H|an unborn baby, women who are pregnant or who may become pregnant||
1449|065|H|should not handle this medication.||
1449|066|B|||
1449|067|S|SIDE EFFECTS:  Nausea/vomiting, decreased appetite, dry mouth,||
1449|068|S|tiredness, dizziness, headache, or joint/muscle pain may occur.||
1449|069|S|If any of these effects last or get worse, tell your doctor or||
1449|070|S|pharmacist promptly.||
1449|071|S|   Remember that this medication has been prescribed because your||
1449|072|S|doctor has judged that the benefit to you is greater than the||
1449|073|S|risk of side effects. Many people using this medication do not||
1449|074|S|have serious side effects.||
1449|075|S|   Tell your doctor right away if you have any serious side||
1449|076|S|effects, including: swelling hands/ankles/feet, unusual vaginal||
1449|077|S|bleeding, symptoms of low level of potassium in the blood (such||
1449|078|S|as muscle cramps, weakness), signs of infection (such as sore||
1449|079|S|throat that doesn't go away, fever, chills, shortness of breath).||
1449|080|S|   This medication can cause low blood sugar (hypoglycemia).||
1449|081|S|Symptoms of low blood sugar include sudden sweating, shaking,||
1449|082|S|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
1449|083|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1449|084|S|treat low blood sugar. If you don't have these reliable forms of||
1449|085|S|glucose, rapidly raise your blood sugar by eating a quick source||
1449|086|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1449|087|S|juice or non-diet soda. Tell your doctor right away about the||
1449|088|S|reaction and the use of this product. To help prevent low blood||
1449|089|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1449|090|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1449|091|S|thirst/urination. If these symptoms occur, tell your doctor right||
1449|092|S|away. Your doctor may need to adjust your diabetes medication,||
1449|093|S|exercise program, or diet.||
1449|094|S|   Get medical help right away if you have any very serious side||
1449|095|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1449|096|S|fainting.||
1449|097|S|   A very serious allergic reaction to this drug is rare.||
1449|098|S|However, get medical help right away if you notice any symptoms||
1449|099|S|of a serious allergic reaction, including: rash, itching/swelling||
1449|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1449|101|S|breathing.||
1449|102|S|   This is not a complete list of possible side effects. If you||
1449|103|S|notice other effects not listed above, contact your doctor or||
1449|104|S|pharmacist.||
1449|105|S|   In the US -||
1449|106|S|   Call your doctor for medical advice about side effects. You||
1449|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1449|108|S|www.fda.gov/medwatch.||
1449|109|S|   In Canada - Call your doctor for medical advice about side||
1449|110|S|effects. You may report side effects to Health Canada at||
1449|111|S|1-866-234-2345.||
1449|112|B|||
1449|113|P|PRECAUTIONS:  Before taking mifepristone, tell your doctor or||
1449|114|P|pharmacist if you are allergic to it; or if you have any other||
1449|115|P|allergies. This product may contain inactive ingredients, which||
1449|116|P|can cause allergic reactions or other problems. Talk to your||
1449|117|P|pharmacist for more details.||
1449|118|P|   Before using this medication, tell your doctor or pharmacist||
1449|119|P|your medical history, especially of: kidney disease, liver||
1449|120|P|disease, vaginal bleeding of unknown cause, problems with the||
1449|121|P|lining of the uterus (endometrial hyperplasia, endometrial||
1449|122|P|cancer), mineral imbalance (low level of potassium in the blood),||
1449|123|P|heart disease (such as coronary artery disease), high blood||
1449|124|P|pressure.||
1449|125|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1449|126|P|can make you more dizzy. Do not drive, use machinery, or do||
1449|127|P|anything that needs alertness until you can do it safely. Limit||
1449|128|P|alcoholic beverages. Talk to your doctor if you are using||
1449|129|P|marijuana (cannabis).||
1449|130|P|   Before having surgery, tell your doctor or dentist about all||
1449|131|P|the products you use (including prescription drugs,||
1449|132|P|nonprescription drugs, and herbal products).||
1449|133|P|   Mifepristone may cause a condition that affects the heart||
1449|134|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1449|135|P|serious (rarely fatal) fast/irregular heartbeat and other||
1449|136|P|symptoms (such as severe dizziness, fainting) that need medical||
1449|137|P|attention right away.||
1449|138|P|   The risk of QT prolongation may be increased if you have||
1449|139|P|certain medical conditions or are taking other drugs that may||
1449|140|P|cause QT prolongation. Before using mifepristone, tell your||
1449|141|P|doctor or pharmacist of all the drugs you take and if you have||
1449|142|P|any of the following conditions: certain heart problems (heart||
1449|143|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1449|144|P|history of certain heart problems (QT prolongation in the EKG,||
1449|145|P|sudden cardiac death).||
1449|146|P|   Low levels of potassium or magnesium in the blood may also||
1449|147|P|increase your risk of QT prolongation. This risk may increase if||
1449|148|P|you use certain drugs (such as diuretics/"water pills") or if you||
1449|149|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1449|150|P|Talk to your doctor about using mifepristone safely.||
1449|151|P|   Older adults may be more sensitive to the side effects of this||
1449|152|P|drug, especially QT prolongation (see above).||
1449|153|P|   Mifepristone must not be used during pregnancy. It may cause a||
1449|154|P|loss of pregnancy. If you become pregnant or think you may be||
1449|155|P|pregnant, tell your doctor right away. (See also Warning||
1449|156|P|section.) Since this drug can be absorbed through the skin and||
1449|157|P|may harm an unborn baby, women who are pregnant or who may become||
1449|158|P|pregnant should not handle this medication.||
1449|159|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1449|160|P|your doctor for managing your blood sugar while pregnant. Your||
1449|161|P|doctor may change your diabetes treatment during your pregnancy||
1449|162|P|(such as diet and medications including insulin).||
1449|163|P|   This medication passes into breast milk. Consult your doctor||
1449|164|P|before breastfeeding.||
1449|165|B|||
1449|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1449|167|I|medications work or increase your risk for serious side effects.||
1449|168|I|This document does not contain all possible drug interactions.||
1449|169|I|Keep a list of all the products you use (including||
1449|170|I|prescription/nonprescription drugs and herbal products) and share||
1449|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
1449|172|I|the dosage of any medicines without your doctor's approval.||
1449|173|I|   Some products that may interact with this drug include:||
1449|174|I|corticosteroids (such as prednisone).||
1449|175|I|   Mifepristone can slow down the removal of other medications||
1449|176|I|from your body, which may affect how they work. Examples of||
1449|177|I|affected drugs include cyclosporine, ergot alkaloids (such as||
1449|178|I|dihydroergotamine, ergotamine), fentanyl, pimozide, quinidine,||
1449|179|I|some statin drugs (such as fluvastatin, lovastatin, simvastatin),||
1449|180|I|sirolimus, tacrolimus, warfarin, among others.||
1449|181|I|   Other medications can affect the removal of mifepristone from||
1449|182|I|your body, which may affect how mifepristone works. Examples||
1449|183|I|include azole antifungals (such as itraconazole, ketoconazole,||
1449|184|I|posaconazole), macrolide antibiotics (such as clarithromycin),||
1449|185|I|nefazodone, HIV protease inhibitors (nelfinavir), rifamycins||
1449|186|I|(such as rifabutin, rifampin), ritonavir, telithromycin, among||
1449|187|I|others.||
1449|188|I|   This medication may decrease the effectiveness of hormonal||
1449|189|I|birth control such as pills, patch, or ring. This could cause||
1449|190|I|pregnancy. Discuss with your doctor or pharmacist about||
1449|191|I|non-hormonal birth control methods while using this medication.||
1449|192|I|(See also Warning section.)||
1449|193|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1449|194|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1449|195|I|heartbeat you would usually feel when your blood sugar falls too||
1449|196|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1449|197|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1449|198|I|   Many drugs can affect your blood sugar, making it harder to||
1449|199|I|control. Before you start, stop, or change any medication, talk||
1449|200|I|with your doctor or pharmacist about how the medication may||
1449|201|I|affect your blood sugar. Check your blood sugar regularly as||
1449|202|I|directed and share the results with your doctor. Tell your doctor||
1449|203|I|right away if you have symptoms of high or low blood sugar. (See||
1449|204|I|also Side Effects section.) Your doctor may need to adjust your||
1449|205|I|diabetes medication, exercise program, or diet.||
1449|206|B|||
1449|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1449|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1449|209|O|poison control center right away. US residents can call||
1449|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1449|211|B|||
1449|212|N|NOTES:  Do not share this medication with others.||
1449|213|N|   Lab and/or medical tests (such as potassium levels, thyroid||
1449|214|N|function, blood pressure) should be done while you are taking||
1449|215|N|this medication. Keep all medical and lab appointments. Consult||
1449|216|N|your doctor for more details.||
1449|217|B|||
1449|218|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1449|219|D|remember. If it is near the time of the next dose, skip the||
1449|220|D|missed dose. Take your next dose at the regular time. Do not||
1449|221|D|double the dose to catch up.||
1449|222|B|||
1449|223|R|STORAGE:  Store at room temperature away from light and moisture.||
1449|224|R|Do not store in the bathroom. Keep all medications away from||
1449|225|R|children and pets.||
1449|226|R|   Do not flush medications down the toilet or pour them into a||
1449|227|R|drain unless instructed to do so. Properly discard this product||
1449|228|R|when it is expired or no longer needed. Consult your pharmacist||
1449|229|R|or local waste disposal company.||
1449|230|B|||
1449|231|A|Information last revised November 2025.||
1449|232|A|Copyright(c) 2025 First Databank, Inc.||
1449|233|B|||
1450|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1450|002|Z|does NOT have all possible information about this product. This||
1450|003|Z|information does not assure that this product is safe, effective,||
1450|004|Z|or appropriate for you. This information is not individual||
1450|005|Z|medical advice and does not substitute for the advice of your||
1450|006|Z|health care professional. Always ask your health care||
1450|007|Z|professional for complete information about this product and your||
1450|008|Z|specific health needs.||
1450|009|B|||
1450|010|T|TROLAMINE SALICYLATE - TOPICAL||
1450|011|F|(TROE-la-meen sa-LIS-i-late)||
1450|012|B|||
1450|013|C|COMMON BRAND NAME(S): Myoflex||
1450|014|B|||
1450|015|U|USES:  Trolamine salicylate is used to treat minor aches and||
1450|016|U|pains of the muscles/joints (such as arthritis, backache,||
1450|017|U|sprains). It belongs to a class of drugs known as salicylates.||
1450|018|B|||
1450|019|H|HOW TO USE:  Follow all directions on the product package. If you||
1450|020|H|have any questions, ask your doctor or pharmacist.||
1450|021|H|   This medication is for use on the skin only. Do not get this||
1450|022|H|medication in your eyes, inside your nose or mouth, or inside the||
1450|023|H|vagina. If you do get the medication in those areas, flush with||
1450|024|H|plenty of water.||
1450|025|H|   Apply the medication to the affected area no more than 3 to 4||
1450|026|H|times a day. Rub in gently and thoroughly. After applying the||
1450|027|H|medication, wash your hands unless you are using this medication||
1450|028|H|to treat the hands.||
1450|029|H|   Do not apply this medication on broken or irritated skin. Do||
1450|030|H|not bandage or tightly wrap the affected area or apply heat to||
1450|031|H|the area (such as using a heating pad). Doing so may increase the||
1450|032|H|risk of side effects. Ask your pharmacist for more details.||
1450|033|H|   Tell your doctor if your condition lasts for more than 7 days,||
1450|034|H|if it gets worse, or if it keeps returning. If you think you may||
1450|035|H|have a serious medical problem, get medical help right away.||
1450|036|B|||
1450|037|S|SIDE EFFECTS:  If your doctor has directed you to use this||
1450|038|S|medication, remember that your doctor has judged that the benefit||
1450|039|S|to you is greater than the risk of side effects. Many people||
1450|040|S|using this medication do not have serious side effects.||
1450|041|S|   Stop using this medication and tell your doctor right away if||
1450|042|S|any serious side effects occur, including:||
1450|043|S|blistering/peeling/redness/irritation at the application site,||
1450|044|S|nausea/vomiting, ringing in the ears.||
1450|045|S|   A very serious allergic reaction to this drug is rare.||
1450|046|S|However, get medical help right away if you notice any symptoms||
1450|047|S|of a serious allergic reaction, including: rash, itching/swelling||
1450|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1450|049|S|breathing.||
1450|050|S|   This is not a complete list of possible side effects. If you||
1450|051|S|notice other effects not listed above, contact your doctor or||
1450|052|S|pharmacist.||
1450|053|S|   In the US -||
1450|054|S|   Call your doctor for medical advice about side effects. You||
1450|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1450|056|S|www.fda.gov/medwatch.||
1450|057|S|   In Canada - Call your doctor for medical advice about side||
1450|058|S|effects. You may report side effects to Health Canada at||
1450|059|S|1-866-234-2345.||
1450|060|B|||
1450|061|P|PRECAUTIONS:  Before using trolamine salicylate, tell your doctor||
1450|062|P|or pharmacist if you are allergic to it; or to aspirin or other||
1450|063|P|salicylates (such as salsalate); or if you have any other||
1450|064|P|allergies. This product may contain inactive ingredients, which||
1450|065|P|can cause allergic reactions or other problems. Talk to your||
1450|066|P|pharmacist for more details.||
1450|067|P|   Before using this medication, tell your doctor or pharmacist||
1450|068|P|your medical history, especially of: asthma, growths in the nose||
1450|069|P|(nasal polyps).||
1450|070|P|   Before having surgery, tell your doctor or dentist about all||
1450|071|P|the products you use (including prescription drugs,||
1450|072|P|nonprescription drugs, and herbal products).||
1450|073|P|   This drug is similar to aspirin. Children and teenagers||
1450|074|P|younger than 18 years should not use this drug if they have||
1450|075|P|chickenpox, flu, or any undiagnosed illness or if they have||
1450|076|P|recently received a vaccine. In these cases, this drug may||
1450|077|P|increase the risk of Reye's syndrome, a rare but serious illness.||
1450|078|P|   Tell your doctor if you are pregnant or if you plan to become||
1450|079|P|pregnant. This medication may harm an unborn baby and cause||
1450|080|P|problems with normal labor/delivery. It is not recommended for||
1450|081|P|use in pregnancy from 20 weeks until delivery. If your doctor||
1450|082|P|decides that you need to use this medication between 20 and 30||
1450|083|P|weeks of pregnancy, you should use the lowest effective dose for||
1450|084|P|the shortest possible time. You should not use this medication||
1450|085|P|after 30 weeks of pregnancy. Discuss the risks and benefits with||
1450|086|P|your doctor.||
1450|087|P|   It is unknown if this product passes into breast milk. Consult||
1450|088|P|your doctor before breastfeeding.||
1450|089|B|||
1450|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1450|091|I|medications work or increase your risk for serious side effects.||
1450|092|I|This document does not contain all possible drug interactions.||
1450|093|I|Keep a list of all the products you use (including||
1450|094|I|prescription/nonprescription drugs and herbal products) and share||
1450|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
1450|096|I|the dosage of any medicines without your doctor's approval.||
1450|097|B|||
1450|098|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1450|099|O|has overdosed and has serious symptoms such as passing out or||
1450|100|O|trouble breathing, call 911. Otherwise, call a poison control||
1450|101|O|center right away. US residents can call 1-800-222-1222. Canada||
1450|102|O|residents can call 1-844-764-7669.||
1450|103|B|||
1450|104|N|NOTES:  Keep all medical and lab appointments.||
1450|105|B|||
1450|106|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1450|107|D|If it is near the time of the next dose, skip the missed dose.||
1450|108|D|Use your next dose at the regular time. Do not double the dose to||
1450|109|D|catch up.||
1450|110|B|||
1450|111|R|STORAGE:  Store at room temperature away from heat. Keep all||
1450|112|R|medications away from children and pets.||
1450|113|R|   Do not flush medications down the toilet or pour them into a||
1450|114|R|drain unless instructed to do so. Properly discard this product||
1450|115|R|when it is expired or no longer needed. Consult your pharmacist||
1450|116|R|or local waste disposal company.||
1450|117|B|||
1450|118|A|Information last revised May 2024.||
1450|119|A|Copyright(c) 2025 First Databank, Inc.||
1450|120|B|||
1453|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1453|002|Z|does NOT have all possible information about this product. This||
1453|003|Z|information does not assure that this product is safe, effective,||
1453|004|Z|or appropriate for you. This information is not individual||
1453|005|Z|medical advice and does not substitute for the advice of your||
1453|006|Z|health care professional. Always ask your health care||
1453|007|Z|professional for complete information about this product and your||
1453|008|Z|specific health needs.||
1453|009|B|||
1453|010|T|RUXOLITINIB - ORAL||
1453|011|F|(RUX-oh-LI-ti-nib)||
1453|012|B|||
1453|013|C|COMMON BRAND NAME(S): Jakafi||
1453|014|B|||
1453|015|U|USES:  This medication is used to treat certain bone marrow||
1453|016|U|disorders (myelofibrosis, polycythemia vera). It works by||
1453|017|U|blocking your body from producing substances called growth||
1453|018|U|factors. Growth factors cause cells to grow and divide, and cause||
1453|019|U|the blood cell and spleen problems found in these disorders.||
1453|020|U|Ruxolitinib belongs to a class of drugs known as kinase||
1453|021|U|inhibitors. Though not a cure for these disorders, ruxolitinib||
1453|022|U|may help with some of the symptoms, including abdominal||
1453|023|U|discomfort, pain under left ribs, early feelings of fullness from||
1453|024|U|meals, night sweats, itching, and bone/muscle pain.||
1453|025|U|   Ruxolitinib is also used to treat a certain problem that may||
1453|026|U|occur after certain stem cell or bone marrow transplants (graft||
1453|027|U|versus host disease). It works by weakening your body's defense||
1453|028|U|system (immune system).||
1453|029|B|||
1453|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1453|031|H|from your pharmacist before you start taking ruxolitinib and each||
1453|032|H|time you get a refill. If you have any questions, ask your doctor||
1453|033|H|or pharmacist.||
1453|034|H|   Take this medication by mouth with or without food as directed||
1453|035|H|by your doctor, usually twice daily. If you are unable to swallow||
1453|036|H|the tablets, ask your doctor about other ways to take this||
1453|037|H|medication.||
1453|038|H|   The dosage is based on your medical condition, lab tests,||
1453|039|H|response to treatment, and other medications you may be taking.||
1453|040|H|Be sure to tell your doctor and pharmacist about all the products||
1453|041|H|you use (including prescription drugs, nonprescription drugs, and||
1453|042|H|herbal products).||
1453|043|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1453|044|H|using this medication unless your doctor or pharmacist says you||
1453|045|H|may do so safely. Grapefruit can increase the chance of side||
1453|046|H|effects with this medicine. Ask your doctor or pharmacist for||
1453|047|H|more details.||
1453|048|H|   To reduce your risk of side effects, your doctor may direct||
1453|049|H|you to start this medication at a low dose and gradually increase||
1453|050|H|your dose. Follow your doctor's instructions carefully. Do not||
1453|051|H|increase your dose or use this drug more often or for longer than||
1453|052|H|prescribed. Your condition will not improve any faster, and your||
1453|053|H|risk of side effects will increase.||
1453|054|H|   Use this medication regularly to get the most benefit from it.||
1453|055|H|To help you remember, take it at the same times each day.||
1453|056|H|   Do not stop taking ruxolitinib without consulting your doctor.||
1453|057|H|Some conditions may become worse when this drug is suddenly||
1453|058|H|stopped. Also, you may experience symptoms such as fever, trouble||
1453|059|H|breathing, dizziness, and unusual bleeding/bruising. To prevent||
1453|060|H|these symptoms while you are stopping treatment with this drug,||
1453|061|H|your doctor may reduce your dose gradually. Consult your doctor||
1453|062|H|or pharmacist for more details. Report any new or worsening||
1453|063|H|symptoms right away.||
1453|064|H|   Tell your doctor if your symptoms do not get better or if they||
1453|065|H|get worse.||
1453|066|B|||
1453|067|S|SIDE EFFECTS:  Dizziness, diarrhea, headache, weight gain, or gas||
1453|068|S|may occur. If any of these effects last or get worse, tell your||
1453|069|S|doctor or pharmacist promptly.||
1453|070|S|   People using this medication may have serious side effects.||
1453|071|S|However, you have been prescribed this drug because your doctor||
1453|072|S|has judged that the benefit to you is greater than the risk of||
1453|073|S|side effects. Careful monitoring by your doctor may decrease your||
1453|074|S|risk.||
1453|075|S|   Tell your doctor right away if you have any serious side||
1453|076|S|effects, including: unusual tiredness, easy bleeding/bruising,||
1453|077|S|unusual skin changes.||
1453|078|S|   This medication may lower your ability to fight infections.||
1453|079|S|This may make you more likely to get a serious (rarely fatal)||
1453|080|S|infection or make any infection you have worse. Tell your doctor||
1453|081|S|right away if you have any signs of infection (such as sore||
1453|082|S|throat that doesn't go away, fever, chills, painful skin||
1453|083|S|rash/blisters).||
1453|084|S|   This medication may also increase your risk of getting a rare||
1453|085|S|but very serious (sometimes fatal) brain infection (progressive||
1453|086|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1453|087|S|if any of these rare but very serious side effects occur:||
1453|088|S|clumsiness, loss of coordination, weakness, sudden change in your||
1453|089|S|thinking (such as confusion, difficulty concentrating),||
1453|090|S|difficulty moving your muscles, problems with speech, seizure,||
1453|091|S|vision changes.||
1453|092|S|   Another medication similar to ruxolitinib has caused serious||
1453|093|S|(possibly fatal) side effects, including heart problems, blood||
1453|094|S|clots, and cancer (such as lymphoma). Before using ruxolitinib,||
1453|095|S|tell your doctor or pharmacist if you have a history of heart||
1453|096|S|disease, stroke, cancer, or any risk factors for heart disease||
1453|097|S|(such as high blood pressure, diabetes, previous blood clots,||
1453|098|S|high cholesterol, smoking or history of smoking). Discuss the||
1453|099|S|risks and benefits of treatment with your doctor. Get medical||
1453|100|S|help right away if you have symptoms such as: shortness of||
1453|101|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
1453|102|S|sweating, confusion, sudden dizziness/fainting,||
1453|103|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1453|104|S|trouble speaking, weakness on one side of the body, sudden vision||
1453|105|S|changes.||
1453|106|S|   A very serious allergic reaction to this drug is rare.||
1453|107|S|However, get medical help right away if you notice any symptoms||
1453|108|S|of a serious allergic reaction, including: rash, itching/swelling||
1453|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1453|110|S|breathing.||
1453|111|S|   This is not a complete list of possible side effects. If you||
1453|112|S|notice other effects not listed above, contact your doctor or||
1453|113|S|pharmacist.||
1453|114|S|   In the US -||
1453|115|S|   Call your doctor for medical advice about side effects. You||
1453|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1453|117|S|www.fda.gov/medwatch.||
1453|118|S|   In Canada - Call your doctor for medical advice about side||
1453|119|S|effects. You may report side effects to Health Canada at||
1453|120|S|1-866-234-2345.||
1453|121|B|||
1453|122|P|PRECAUTIONS:  See also Side Effects section.||
1453|123|P|   Before taking ruxolitinib, tell your doctor or pharmacist if||
1453|124|P|you are allergic to it; or if you have any other allergies. This||
1453|125|P|product may contain inactive ingredients, which can cause||
1453|126|P|allergic reactions or other problems. Talk to your pharmacist for||
1453|127|P|more details.||
1453|128|P|   Before using this medication, tell your doctor or pharmacist||
1453|129|P|your medical history, especially of: current/past/returning||
1453|130|P|infections (such as herpes, tuberculosis), kidney disease, liver||
1453|131|P|disease, cancer (such as skin cancer).||
1453|132|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1453|133|P|can make you more dizzy. Do not drive, use machinery, or do||
1453|134|P|anything that needs alertness until you can do it safely. Limit||
1453|135|P|alcoholic beverages. Talk to your doctor if you are using||
1453|136|P|marijuana (cannabis).||
1453|137|P|   Ruxolitinib can make you more likely to get infections or may||
1453|138|P|make current infections worse. Stay away from anyone who has an||
1453|139|P|infection that may easily spread (such as chickenpox, COVID-19,||
1453|140|P|measles, flu, tuberculosis). Talk to your doctor if you have been||
1453|141|P|exposed to an infection or for more details.||
1453|142|P|   Tell your health care professional that you are using||
1453|143|P|ruxolitinib before having any immunizations/vaccinations. Avoid||
1453|144|P|contact with people who have recently received live vaccines||
1453|145|P|(such as flu vaccine inhaled through the nose).||
1453|146|P|   Before having surgery, tell your doctor or dentist about all||
1453|147|P|the products you use (including prescription drugs,||
1453|148|P|nonprescription drugs, and herbal products).||
1453|149|P|   During pregnancy, this medication should be used only when||
1453|150|P|clearly needed. Discuss the risks and benefits with your doctor.||
1453|151|P|   It is unknown if this medication passes into breast milk.||
1453|152|P|Because of the possible risk to the infant, breastfeeding is not||
1453|153|P|recommended while using this medication and for 2 weeks after the||
1453|154|P|last dose. Consult your doctor before breastfeeding.||
1453|155|B|||
1453|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1453|157|I|medications work or increase your risk for serious side effects.||
1453|158|I|This document does not contain all possible drug interactions.||
1453|159|I|Keep a list of all the products you use (including||
1453|160|I|prescription/nonprescription drugs and herbal products) and share||
1453|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
1453|162|I|the dosage of any medicines without your doctor's approval.||
1453|163|I|   Some products that may interact with this drug include: other||
1453|164|I|drugs that weaken the immune system/increase the risk of||
1453|165|I|infection (such as natalizumab, rituximab).||
1453|166|B|||
1453|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1453|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1453|169|O|poison control center right away. US residents can call||
1453|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1453|171|B|||
1453|172|N|NOTES:  Do not share this medication with others.||
1453|173|N|   Lab and/or medical tests (such as complete blood counts,||
1453|174|N|cholesterol/triglyceride levels, skin exams) should be done||
1453|175|N|before you start taking this medication and while you are taking||
1453|176|N|it. Keep all medical and lab appointments. Consult your doctor||
1453|177|N|for more details.||
1453|178|B|||
1453|179|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1453|180|D|next dose at the regular time. Do not double the dose to catch||
1453|181|D|up.||
1453|182|B|||
1453|183|R|STORAGE:  Store at room temperature away from light and moisture.||
1453|184|R|Do not store in the bathroom. Keep all medications away from||
1453|185|R|children and pets.||
1453|186|R|   Do not flush medications down the toilet or pour them into a||
1453|187|R|drain unless instructed to do so. Properly discard this product||
1453|188|R|when it is expired or no longer needed. Consult your pharmacist||
1453|189|R|or local waste disposal company.||
1453|190|B|||
1453|191|A|Information last revised April 2025.||
1453|192|A|Copyright(c) 2025 First Databank, Inc.||
1453|193|B|||
1454|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1454|002|Z|does NOT have all possible information about this product. This||
1454|003|Z|information does not assure that this product is safe, effective,||
1454|004|Z|or appropriate for you. This information is not individual||
1454|005|Z|medical advice and does not substitute for the advice of your||
1454|006|Z|health care professional. Always ask your health care||
1454|007|Z|professional for complete information about this product and your||
1454|008|Z|specific health needs.||
1454|009|B|||
1454|010|T|BECLOMETHASONE HFA INHALER - NASAL||
1454|011|F|(BE-kloe-METH-a-sone)||
1454|012|B|||
1454|013|C|COMMON BRAND NAME(S): Qnasl||
1454|014|B|||
1454|015|U|USES:  This medication is used to treat seasonal and year-round||
1454|016|U|allergy symptoms such as stuffy/runny nose, itching, and||
1454|017|U|sneezing. It may also reduce other symptoms of seasonal allergies||
1454|018|U|such as red, itchy, and watery eyes. This medication belongs to a||
1454|019|U|class of drugs known as corticosteroids. It works by reducing||
1454|020|U|swelling (inflammation) in the nasal passages.||
1454|021|B|||
1454|022|V|OTHER USES:  This section contains uses of this drug that are not||
1454|023|V|listed in the approved professional labeling for the drug but||
1454|024|V|that may be prescribed by your health care professional. Use this||
1454|025|V|drug for a condition that is listed in this section only if it||
1454|026|V|has been so prescribed by your health care professional.||
1454|027|V|   This drug may also be used to keep growths in the nose (nasal||
1454|028|V|polyps) from coming back after removal by surgery. This drug may||
1454|029|V|also be used for symptoms (such as stuffy/runny nose) caused by||
1454|030|V|other triggers (such as cigarette smoke, perfumes).||
1454|031|B|||
1454|032|H|HOW TO USE:  Read the Patient Information Leaflet before you||
1454|033|H|start using beclomethasone and each time you get a refill. If you||
1454|034|H|have any questions, ask your doctor or pharmacist.||
1454|035|H|   Use this medication in the nose as directed by your doctor,||
1454|036|H|usually once a day. Do not spray in your eyes or mouth.||
1454|037|H|   If this medication is used by a child, a parent or other||
1454|038|H|responsible adult should supervise and help the child use this||
1454|039|H|medication properly.||
1454|040|H|   Gently blow your nose before using this drug. Follow the||
1454|041|H|instructions on how to properly prime the inhaler if you are||
1454|042|H|using it for the first time or if you have not used it for more||
1454|043|H|than 7 days in a row.||
1454|044|H|   The dosage is based on your age, medical condition, and||
1454|045|H|response to treatment. Do not increase your dose or use it more||
1454|046|H|often than directed since this may increase the risk of side||
1454|047|H|effects.||
1454|048|H|   This medication does not work right away. Some people will||
1454|049|H|feel this medication working within several days, but it may take||
1454|050|H|up to 2 weeks before you get the full benefit of this drug. Ask||
1454|051|H|your doctor or pharmacist if you should also use other allergy||
1454|052|H|medications along with this drug until it takes full effect.||
1454|053|H|   Use this medication regularly to get the most benefit from it.||
1454|054|H|To help you remember, use it at the same time each day.||
1454|055|H|   Wipe the inhaler regularly with a clean, dry tissue or cloth.||
1454|056|H|Do not take the inhaler apart. Do not wash or put any part of the||
1454|057|H|inhaler in water. Keep track of the number of sprays used from||
1454|058|H|the container. Discard the container after you have used the||
1454|059|H|number of sprays specified on the manufacturer's package.||
1454|060|H|   Tell your doctor if your condition does not get better or if||
1454|061|H|it gets worse.||
1454|062|B|||
1454|063|S|SIDE EFFECTS:  Mild nosebleeds, nasal dryness/irritation,||
1454|064|S|unpleasant taste/smell may occur. If any of these effects last or||
1454|065|S|get worse, tell your doctor or pharmacist promptly.||
1454|066|S|   Remember that this medication has been prescribed because your||
1454|067|S|doctor has judged that the benefit to you is greater than the||
1454|068|S|risk of side effects. Many people using this medication do not||
1454|069|S|have serious side effects.||
1454|070|S|   Tell your doctor right away if you have any serious side||
1454|071|S|effects, including: pain/sores in the nose, loss of taste or||
1454|072|S|smell, signs of infection (such as sore throat that doesn't go||
1454|073|S|away, white patches in your nose/back of your throat, fever,||
1454|074|S|chills).||
1454|075|S|   Rarely, it is possible that corticosteroids given in the nose||
1454|076|S|will be absorbed into the bloodstream. This can lead to side||
1454|077|S|effects of too much corticosteroid. These side effects are more||
1454|078|S|likely in children and people who use this medication for a long||
1454|079|S|time and in high doses. Tell your doctor right away if any of the||
1454|080|S|following side effects occur: unusual/extreme tiredness, weight||
1454|081|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
1454|082|S|vision problems.||
1454|083|S|   A very serious allergic reaction to this drug is rare.||
1454|084|S|However, get medical help right away if you notice any symptoms||
1454|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1454|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1454|087|S|breathing.||
1454|088|S|   This is not a complete list of possible side effects. If you||
1454|089|S|notice other effects not listed above, contact your doctor or||
1454|090|S|pharmacist.||
1454|091|S|   In the US -||
1454|092|S|   Call your doctor for medical advice about side effects. You||
1454|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1454|094|S|www.fda.gov/medwatch.||
1454|095|S|   In Canada - Call your doctor for medical advice about side||
1454|096|S|effects. You may report side effects to Health Canada at||
1454|097|S|1-866-234-2345.||
1454|098|B|||
1454|099|P|PRECAUTIONS:  Before taking nasal beclomethasone, tell your||
1454|100|P|doctor or pharmacist if you are allergic to it; or if you have||
1454|101|P|any other allergies. This product may contain inactive||
1454|102|P|ingredients, which can cause allergic reactions or other||
1454|103|P|problems. Talk to your pharmacist for more details.||
1454|104|P|   Before using this medication, tell your doctor or pharmacist||
1454|105|P|your medical history, especially of: recent nose problems (such||
1454|106|P|as injury, ulcers, surgery), certain eye problems (glaucoma,||
1454|107|P|cataracts), current/past infections (such as those caused by||
1454|108|P|tuberculosis, herpes, fungus).||
1454|109|P|   Stay away from anyone who has an infection that may easily||
1454|110|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1454|111|P|doctor if you have been exposed to an infection or for more||
1454|112|P|details.||
1454|113|P|   Rarely, using corticosteroid medications for a long time can||
1454|114|P|make it more difficult for your body to respond to physical||
1454|115|P|stress. Before having surgery or emergency treatment, or if you||
1454|116|P|get a serious illness/injury, tell your doctor or dentist that||
1454|117|P|you are using this medication or have used this medication within||
1454|118|P|the past few months.||
1454|119|P|   Though it is unlikely, this medication may temporarily slow||
1454|120|P|down a child's growth if used for a long time. See the doctor||
1454|121|P|regularly so your child's height can be checked.||
1454|122|P|   During pregnancy, this medication should be used only when||
1454|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
1454|124|P|   It is unknown if this medication passes into breast milk.||
1454|125|P|Consult your doctor before breastfeeding.||
1454|126|B|||
1454|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1454|128|I|medications work or increase your risk for serious side effects.||
1454|129|I|This document does not contain all possible drug interactions.||
1454|130|I|Keep a list of all the products you use (including||
1454|131|I|prescription/nonprescription drugs and herbal products) and share||
1454|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
1454|133|I|the dosage of any medicines without your doctor's approval.||
1454|134|B|||
1454|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1454|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1454|137|O|poison control center right away. US residents can call||
1454|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1454|139|B|||
1454|140|N|NOTES:  Do not share this medication with others.||
1454|141|N|   If you use this medication for a long time, lab and/or medical||
1454|142|N|tests (such as nose exams, height measurement in children) may be||
1454|143|N|done while you are using this medication. Keep all medical and||
1454|144|N|lab appointments. Consult your doctor for more details.||
1454|145|N|   Ask your doctor for ways to reduce your exposure to substances||
1454|146|N|(such as pollen, pet dander, dust mites, mold, smoke) that can||
1454|147|N|worsen allergy symptoms.||
1454|148|B|||
1454|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1454|150|D|remember. If it is near the time of the next dose, skip the||
1454|151|D|missed dose. Take your next dose at the regular time. Do not||
1454|152|D|double the dose to catch up.||
1454|153|B|||
1454|154|R|STORAGE:  Store with the cap on at room temperature away from||
1454|155|R|heat or open flame. Keep all medications away from children and||
1454|156|R|pets.||
1454|157|R|   Do not flush medications down the toilet or pour them into a||
1454|158|R|drain unless instructed to do so. Properly discard this product||
1454|159|R|when it is expired or no longer needed. Consult your pharmacist||
1454|160|R|or local waste disposal company.||
1454|161|B|||
1454|162|A|Information last revised October 2024.||
1454|163|A|Copyright(c) 2025 First Databank, Inc.||
1454|164|B|||
1455|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1455|002|Z|does NOT have all possible information about this product. This||
1455|003|Z|information does not assure that this product is safe, effective,||
1455|004|Z|or appropriate for you. This information is not individual||
1455|005|Z|medical advice and does not substitute for the advice of your||
1455|006|Z|health care professional. Always ask your health care||
1455|007|Z|professional for complete information about this product and your||
1455|008|Z|specific health needs.||
1455|009|B|||
1455|010|T|AFLIBERCEPT - INTRAOCULAR||
1455|011|F|(a-FLIB-er-sept)||
1455|012|B|||
1455|013|C|COMMON BRAND NAME(S): Eylea, Eylea HD, Pavblu||
1455|014|B|||
1455|015|U|USES:  Aflibercept is used to treat certain serious eye||
1455|016|U|conditions (such as macular edema/degeneration, diabetic||
1455|017|U|retinopathy, retinopathy of prematurity). This medication can||
1455|018|U|help preserve vision and prevent blindness. Aflibercept belongs||
1455|019|U|to a class of drugs known as growth factor inhibitors. It works||
1455|020|U|by slowing the growth of abnormal new blood vessels in the eye||
1455|021|U|and decreasing leakage from these blood vessels.||
1455|022|U|   This monograph is about the following aflibercept products:||
1455|023|U|aflibercept, aflibercept-ayyh.||
1455|024|B|||
1455|025|H|HOW TO USE:  This medication is prepared and given by injection||
1455|026|H|into the affected eye(s) by a health care professional. The||
1455|027|H|affected eye is numbed before each injection. After the||
1455|028|H|injection, you will remain in the doctor's office for a while,||
1455|029|H|and your eye(s) and vision will be monitored.||
1455|030|H|   The dosage and treatment schedule are based on your medical||
1455|031|H|condition, age, and response to treatment. For the best effect,||
1455|032|H|carefully follow your doctor's directions. Use this medication||
1455|033|H|regularly to get the most benefit from it.||
1455|034|H|   Tell your doctor if your condition gets worse.||
1455|035|B|||
1455|036|S|SIDE EFFECTS:  Injection site pain, feeling as if something is in||
1455|037|S|the eye, or increased tears may occur. If any of these effects||
1455|038|S|last or get worse, tell your doctor or pharmacist promptly.||
1455|039|S|   Remember that this medication has been prescribed because your||
1455|040|S|doctor has judged that the benefit to you is greater than the||
1455|041|S|risk of side effects. Many people using this medication do not||
1455|042|S|have serious side effects.||
1455|043|S|   Tell your doctor right away if you have any serious side||
1455|044|S|effects, including: floaters (blurry shapes that seem to float in||
1455|045|S|front of your eyes), swollen eyelids.||
1455|046|S|   Get medical help right away if you have any very serious side||
1455|047|S|effects, including: chest/jaw/left arm pain, shortness of breath,||
1455|048|S|unusual sweating, weakness on one side of the body, trouble||
1455|049|S|speaking, confusion.||
1455|050|S|   This medication may rarely increase your risk for developing||
1455|051|S|certain serious eye conditions (endophthalmitis, retinal||
1455|052|S|detachment, retinal vasculitis). Get medical help right away if||
1455|053|S|you notice any of these symptoms in the affected eye(s): pain,||
1455|054|S|redness, sensitivity to light, blurred vision, sudden change in||
1455|055|S|vision, loss of vision.||
1455|056|S|   A very serious allergic reaction to this drug is rare.||
1455|057|S|However, get medical help right away if you notice any symptoms||
1455|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1455|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1455|060|S|breathing.||
1455|061|S|   This is not a complete list of possible side effects. If you||
1455|062|S|notice other effects not listed above, contact your doctor or||
1455|063|S|pharmacist.||
1455|064|S|   In the US -||
1455|065|S|   Call your doctor for medical advice about side effects. You||
1455|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1455|067|S|www.fda.gov/medwatch.||
1455|068|S|   In Canada - Call your doctor for medical advice about side||
1455|069|S|effects. You may report side effects to Health Canada at||
1455|070|S|1-866-234-2345.||
1455|071|B|||
1455|072|P|PRECAUTIONS:  Before using aflibercept, tell your doctor or||
1455|073|P|pharmacist if you are allergic to it; or to other aflibercept||
1455|074|P|products; or if you have any other allergies. This product may||
1455|075|P|contain inactive ingredients, which can cause allergic reactions||
1455|076|P|or other problems. Talk to your pharmacist for more details.||
1455|077|P|   Before using this medication, tell your doctor or pharmacist||
1455|078|P|your medical history, especially of: current eye||
1455|079|P|infection/swelling.||
1455|080|P|   This drug may cause blurred vision. Do not drive, use||
1455|081|P|machinery, or do anything that needs clear vision until you can||
1455|082|P|do it safely.||
1455|083|P|   Before having surgery, tell your doctor or dentist about all||
1455|084|P|the products you use (including prescription drugs,||
1455|085|P|nonprescription drugs, and herbal products).||
1455|086|P|   During pregnancy, this medication should be used only when||
1455|087|P|clearly needed. Discuss the risks and benefits, and ask your||
1455|088|P|doctor which reliable forms of birth control to use during and||
1455|089|P|for some time after the last dose. If you become pregnant or||
1455|090|P|think you may be pregnant, tell your doctor right away.||
1455|091|P|   It is unknown if this medication passes into breast milk.||
1455|092|P|Consult your doctor before breastfeeding.||
1455|093|B|||
1455|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1455|095|I|medications work or increase your risk for serious side effects.||
1455|096|I|This document does not contain all possible drug interactions.||
1455|097|I|Keep a list of all the products you use (including||
1455|098|I|prescription/nonprescription drugs and herbal products) and share||
1455|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
1455|100|I|the dosage of any medicines without your doctor's approval.||
1455|101|I|   Some products that may interact with this drug include:||
1455|102|I|products applied to the eye (such as eye drops).||
1455|103|B|||
1455|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1455|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1455|106|O|poison control center right away. US residents can call||
1455|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1455|108|B|||
1455|109|N|NOTES:  Medical tests (such as eye exams) should be done while||
1455|110|N|you are using this medication. Keep all medical appointments.||
1455|111|N|Consult your doctor for more details.||
1455|112|B|||
1455|113|D|MISSED DOSE:  It is important to get each dose of this medication||
1455|114|D|as scheduled. If you miss a dose, ask your doctor right away for||
1455|115|D|a new dosing schedule.||
1455|116|B|||
1455|117|R|STORAGE:  Not applicable. This medication is given in a hospital||
1455|118|R|or doctor's office and will not be stored at home.||
1455|119|B|||
1455|120|A|Information last revised April 2025.||
1455|121|A|Copyright(c) 2025 First Databank, Inc.||
1455|122|B|||
1456|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1456|002|Z|does NOT have all possible information about this product. This||
1456|003|Z|information does not assure that this product is safe, effective,||
1456|004|Z|or appropriate for you. This information is not individual||
1456|005|Z|medical advice and does not substitute for the advice of your||
1456|006|Z|health care professional. Always ask your health care||
1456|007|Z|professional for complete information about this product and your||
1456|008|Z|specific health needs.||
1456|009|B|||
1456|010|T|DEFERIPRONE (THREE TIMES A DAY) - ORAL||
1456|011|F|(de-FER-i-prone)||
1456|012|B|||
1456|013|C|COMMON BRAND NAME(S): Ferriprox, Ferriprox (3 times a day)||
1456|014|B|||
1456|015|W|WARNING:  This medication may rarely cause a very serious low||
1456|016|W|white blood cell count, which increases your risk of serious,||
1456|017|W|possibly fatal infections. To lower your risk, your doctor will||
1456|018|W|check your blood counts with a blood test before treatment and||
1456|019|W|regularly during treatment. Get medical help right away if you||
1456|020|W|develop any signs of infection (such as sore throat that doesn't||
1456|021|W|go away, fever, chills).||
1456|022|B|||
1456|023|U|USES:  This medication is used by people with certain blood||
1456|024|U|disorders (such as thalassemia, sickle cell anemia) who have too||
1456|025|U|much iron in the body, caused by repeated blood transfusions.||
1456|026|U|Blood transfusions help people with blood disorders but they also||
1456|027|U|bring extra iron into the body. It is important to get rid of the||
1456|028|U|extra iron because high levels of iron can cause health problems||
1456|029|U|(such as heart failure, liver disease, diabetes, delayed growth||
1456|030|U|in children). Deferiprone is used if you have trouble taking||
1456|031|U|other traditional iron-removal medications or you continue to||
1456|032|U|have high iron levels after taking other iron-removal||
1456|033|U|medications.||
1456|034|U|   Deferiprone belongs to a class of drugs known as iron||
1456|035|U|chelators. It works by attaching to iron which helps your body||
1456|036|U|pass the extra iron out in the urine.||
1456|037|B|||
1456|038|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1456|039|H|Patient Information Leaflet provided by your pharmacist before||
1456|040|H|you start taking deferiprone and each time you get a refill. If||
1456|041|H|you have any questions, ask your doctor or pharmacist.||
1456|042|H|   Deferiprone is available in two different formulations:||
1456|043|H|extended-release or immediate-release. Do not switch between the||
1456|044|H|different forms of deferiprone without consulting your doctor. In||
1456|045|H|the US, the immediate-release formulation is also called the||
1456|046|H|"three-times-a-day" formulation.||
1456|047|H|   Take this medication by mouth with or without food as directed||
1456|048|H|by your doctor, usually 3 times daily. Taking this medication||
1456|049|H|with food may help lessen nausea. Take your doses in the morning,||
1456|050|H|at midday, and in the evening.||
1456|051|H|   If you are using the liquid form of this medication, also read||
1456|052|H|the Patient Instructions for Use. Carefully measure the dose||
1456|053|H|using a special measuring cup. Do not use a household spoon||
1456|054|H|because you may not get the correct dose. After you swallow each||
1456|055|H|dose, add about 2 to 3 teaspoonsful (10 to 15 milliliters) of||
1456|056|H|water to the measuring cup. Gently swirl to mix, then drink all||
1456|057|H|of the mixture to make sure you get your full dose. Wash the||
1456|058|H|measuring cup as directed after each time you use it.||
1456|059|H|   The dosage is based on your medical condition, weight, and||
1456|060|H|response to treatment (including lab test results). To reduce||
1456|061|H|your risk of side effects, your doctor may direct you to start||
1456|062|H|this medication at a low dose and gradually increase your dose.||
1456|063|H|Your treatment may need to be adjusted or stopped if you develop||
1456|064|H|serious side effects. Follow your doctor's instructions||
1456|065|H|carefully.||
1456|066|H|   Take this medication regularly to get the most benefit from||
1456|067|H|it. To help you remember, take it at the same times each day.||
1456|068|H|   Take this medication 4 hours apart from products that may bind||
1456|069|H|to it, decreasing its effectiveness. Ask your pharmacist about||
1456|070|H|the other products you take. Some examples include antacids,||
1456|071|H|vitamins/minerals (such as those containing iron, aluminum,||
1456|072|H|zinc), among others.||
1456|073|B|||
1456|074|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1456|075|S|   Nausea, vomiting, stomach/abdominal pain, or joint pain may||
1456|076|S|occur. If any of these effects last or get worse, tell your||
1456|077|S|doctor or pharmacist promptly.||
1456|078|S|   This medication may cause your urine to turn a reddish-brown||
1456|079|S|color. This effect is harmless and will disappear when the||
1456|080|S|medication is stopped.||
1456|081|S|   Remember that this medication has been prescribed because your||
1456|082|S|doctor has judged that the benefit to you is greater than the||
1456|083|S|risk of side effects. Many people using this medication do not||
1456|084|S|have serious side effects.||
1456|085|S|   A very serious allergic reaction to this drug is rare.||
1456|086|S|However, get medical help right away if you notice any symptoms||
1456|087|S|of a serious allergic reaction, including: rash, itching/swelling||
1456|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1456|089|S|breathing.||
1456|090|S|   This is not a complete list of possible side effects. If you||
1456|091|S|notice other effects not listed above, contact your doctor or||
1456|092|S|pharmacist.||
1456|093|S|   In the US -||
1456|094|S|   Call your doctor for medical advice about side effects. You||
1456|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1456|096|S|www.fda.gov/medwatch.||
1456|097|S|   In Canada - Call your doctor for medical advice about side||
1456|098|S|effects. You may report side effects to Health Canada at||
1456|099|S|1-866-234-2345.||
1456|100|B|||
1456|101|P|PRECAUTIONS:  Before taking deferiprone, tell your doctor or||
1456|102|P|pharmacist if you are allergic to it; or if you have any other||
1456|103|P|allergies. This product may contain inactive ingredients, which||
1456|104|P|can cause allergic reactions or other problems. Talk to your||
1456|105|P|pharmacist for more details.||
1456|106|P|   Before using this medication, tell your doctor or pharmacist||
1456|107|P|your medical history, especially of: liver disease, low white||
1456|108|P|blood cell count.||
1456|109|P|   Before having surgery, tell your doctor or dentist about all||
1456|110|P|the products you use (including prescription drugs,||
1456|111|P|nonprescription drugs, and herbal products).||
1456|112|P|   Tell your doctor if you are pregnant or plan to become||
1456|113|P|pregnant. You should not become pregnant while using deferiprone.||
1456|114|P|Deferiprone may harm an unborn baby. Your doctor should order a||
1456|115|P|pregnancy test before you start this medication. Women using this||
1456|116|P|medication should ask about reliable forms of birth control||
1456|117|P|during treatment and for 6 months after the last dose. Men using||
1456|118|P|this medication should ask about reliable forms of birth control||
1456|119|P|during treatment and for 3 months after the last dose. If you or||
1456|120|P|your partner becomes pregnant, talk to your doctor right away||
1456|121|P|about the risks and benefits of this medication.||
1456|122|P|   It is unknown if deferiprone passes into breast milk. Because||
1456|123|P|of the possible risk to the infant, breastfeeding is not||
1456|124|P|recommended while using this medication and for 2 weeks after the||
1456|125|P|last dose. Consult your doctor before breastfeeding.||
1456|126|B|||
1456|127|I|DRUG INTERACTIONS:  See also How to Use section.||
1456|128|I|   Drug interactions may change how your medications work or||
1456|129|I|increase your risk for serious side effects. This document does||
1456|130|I|not contain all possible drug interactions. Keep a list of all||
1456|131|I|the products you use (including prescription/nonprescription||
1456|132|I|drugs and herbal products) and share it with your doctor and||
1456|133|I|pharmacist. Do not start, stop, or change the dosage of any||
1456|134|I|medicines without your doctor's approval.||
1456|135|B|||
1456|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1456|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1456|138|O|poison control center right away. US residents can call||
1456|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1456|140|O|Symptoms of overdose may include: vision problems, weak muscles,||
1456|141|O|unusual/slowed movements.||
1456|142|B|||
1456|143|N|NOTES:  Do not share this medication with others.||
1456|144|N|   Lab and/or medical tests (such as liver function, complete||
1456|145|N|blood counts, ferritin/zinc levels) should be done while you are||
1456|146|N|taking this medication. Keep all medical and lab appointments.||
1456|147|N|Consult your doctor for more details.||
1456|148|B|||
1456|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1456|150|D|remember. If it is near the time of the next dose, skip the||
1456|151|D|missed dose. Take your next dose at the regular time. Do not||
1456|152|D|double the dose to catch up.||
1456|153|B|||
1456|154|R|STORAGE:  Store in the original container at room temperature||
1456|155|R|away from light and moisture. Do not store in the bathroom. Keep||
1456|156|R|the liquid form in the original carton to protect from light and||
1456|157|R|discard 35 days after opening. Keep all medications away from||
1456|158|R|children and pets.||
1456|159|R|   Do not flush medications down the toilet or pour them into a||
1456|160|R|drain unless instructed to do so. Properly discard this product||
1456|161|R|when it is expired or no longer needed. Consult your pharmacist||
1456|162|R|or local waste disposal company.||
1456|163|B|||
1456|164|A|Information last revised April 2025.||
1456|165|A|Copyright(c) 2025 First Databank, Inc.||
1456|166|B|||
1457|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1457|002|Z|does NOT have all possible information about this product. This||
1457|003|Z|information does not assure that this product is safe, effective,||
1457|004|Z|or appropriate for you. This information is not individual||
1457|005|Z|medical advice and does not substitute for the advice of your||
1457|006|Z|health care professional. Always ask your health care||
1457|007|Z|professional for complete information about this product and your||
1457|008|Z|specific health needs.||
1457|009|B|||
1457|010|T|TALIGLUCERASE ALFA - INJECTION||
1457|011|F|(TAL-i-GLOO-ser-ase AL-fa)||
1457|012|B|||
1457|013|C|COMMON BRAND NAME(S): Elelyso||
1457|014|B|||
1457|015|W|WARNING:  Taliglucerase alfa may cause serious (sometimes fatal)||
1457|016|W|allergic reactions. Get medical help right away if you have any||
1457|017|W|symptoms of a serious allergic reaction such as rash,||
1457|018|W|itching/swelling (especially of the face/tongue/throat), severe||
1457|019|W|dizziness, trouble breathing, chest tightness, low blood||
1457|020|W|pressure, nausea, vomiting, flushing, or coughing.||
1457|021|B|||
1457|022|U|USES:  Taliglucerase alfa is used to treat a certain rare genetic||
1457|023|U|problem (Gaucher disease). Taliglucerase alfa replaces a certain||
1457|024|U|natural substance (an enzyme called glucocerebrosidase) that is||
1457|025|U|missing in people with Gaucher disease.||
1457|026|U|   This medication improves blood, bone, liver, and spleen||
1457|027|U|problems caused by Gaucher disease. Taliglucerase alfa does not||
1457|028|U|correct the genetic problem, and treatment must be continued for||
1457|029|U|life.||
1457|030|B|||
1457|031|H|HOW TO USE:  This medication is given by injection into a vein by||
1457|032|H|a health care professional. It is given as directed by your||
1457|033|H|doctor, usually once every 2 weeks. It is injected slowly into a||
1457|034|H|vein over 1 to 2 hours. The dosage is based on your weight,||
1457|035|H|medical condition, and response to treatment.||
1457|036|H|   Tell your doctor if your condition lasts or gets worse. Blood,||
1457|037|H|liver, and spleen problems usually improve in the first year of||
1457|038|H|treatment. It may take 2 to 3 years of treatment to see the full||
1457|039|H|benefit to your bones.||
1457|040|B|||
1457|041|S|SIDE EFFECTS:  See also Warning section.||
1457|042|S|   Redness, pain, itching, or swelling at the injection site may||
1457|043|S|occur. Headache, joint pain, runny nose, sore throat, or flu-like||
1457|044|S|symptoms (such as fever, chills, muscle aches, tiredness) may||
1457|045|S|also occur. If any of these effects last or get worse, tell your||
1457|046|S|doctor or pharmacist promptly.||
1457|047|S|   Remember that this medication has been prescribed because your||
1457|048|S|doctor has judged that the benefit to you is greater than the||
1457|049|S|risk of side effects. Many people using this medication do not||
1457|050|S|have serious side effects.||
1457|051|S|   This is not a complete list of possible side effects. If you||
1457|052|S|notice other effects not listed above, contact your doctor or||
1457|053|S|pharmacist.||
1457|054|S|   In the US -||
1457|055|S|   Call your doctor for medical advice about side effects. You||
1457|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1457|057|S|www.fda.gov/medwatch.||
1457|058|S|   In Canada - Call your doctor for medical advice about side||
1457|059|S|effects. You may report side effects to Health Canada at||
1457|060|S|1-866-234-2345.||
1457|061|B|||
1457|062|P|PRECAUTIONS:  Before using taliglucerase alfa, tell your doctor||
1457|063|P|or pharmacist if you are allergic to it; or to alglucerase; or if||
1457|064|P|you have any other allergies. This product may contain inactive||
1457|065|P|ingredients, which can cause allergic reactions or other||
1457|066|P|problems. Talk to your pharmacist for more details.||
1457|067|P|   Before using this medication, tell your doctor or pharmacist||
1457|068|P|your medical history.||
1457|069|P|   Before having surgery, tell your doctor or dentist about all||
1457|070|P|the products you use (including prescription drugs,||
1457|071|P|nonprescription drugs, and herbal products).||
1457|072|P|   During pregnancy, this medication should be used only when||
1457|073|P|clearly needed. Discuss the risks and benefits with your doctor.||
1457|074|P|   It is unknown if this medication passes into breast milk.||
1457|075|P|Consult your doctor before breastfeeding.||
1457|076|B|||
1457|077|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1457|078|I|medications work or increase your risk for serious side effects.||
1457|079|I|This document does not contain all possible drug interactions.||
1457|080|I|Keep a list of all the products you use (including||
1457|081|I|prescription/nonprescription drugs and herbal products) and share||
1457|082|I|it with your doctor and pharmacist. Do not start, stop, or change||
1457|083|I|the dosage of any medicines without your doctor's approval.||
1457|084|B|||
1457|085|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1457|086|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1457|087|O|poison control center right away. US residents can call||
1457|088|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1457|089|B|||
1457|090|N|NOTES:  Lab and/or medical tests (such as IgG antibodies) should||
1457|091|N|be done while you are using this medication. Keep all medical and||
1457|092|N|lab appointments. Consult your doctor for more details.||
1457|093|B|||
1457|094|D|MISSED DOSE:  It is important to get each dose of this medication||
1457|095|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1457|096|D|right away for a new dosing schedule.||
1457|097|B|||
1457|098|R|STORAGE:  Not applicable. This medication is given in a hospital||
1457|099|R|or clinic or doctor's office and will not be stored at home.||
1457|100|B|||
1457|101|A|Information last revised July 2024.||
1457|102|A|Copyright(c) 2025 First Databank, Inc.||
1457|103|B|||
1458|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1458|002|Z|does NOT have all possible information about this product. This||
1458|003|Z|information does not assure that this product is safe, effective,||
1458|004|Z|or appropriate for you. This information is not individual||
1458|005|Z|medical advice and does not substitute for the advice of your||
1458|006|Z|health care professional. Always ask your health care||
1458|007|Z|professional for complete information about this product and your||
1458|008|Z|specific health needs.||
1458|009|B|||
1458|010|T|DIENOGEST - ORAL||
1458|011|F|(dye-EN-oh-jest)||
1458|012|B|||
1458|013|U|USES:  This medication is used to treat endometriosis. It works||
1458|014|U|by lowering the amount of certain hormones in the body and||
1458|015|U|decreasing the growth of abnormal tissues that cause||
1458|016|U|endometriosis. This helps reduce pain and other symptoms.||
1458|017|U|Dienogest is a type of hormone (progestin).||
1458|018|B|||
1458|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1458|020|H|from your pharmacist before you start taking this drug and each||
1458|021|H|time you get a refill. If you have any questions, ask your doctor||
1458|022|H|or pharmacist.||
1458|023|H|   Take this medication by mouth with or without food as directed||
1458|024|H|by your doctor, usually once daily.||
1458|025|H|   Take this medication regularly to get the most benefit from||
1458|026|H|it. To help you remember, take it at the same time each day.||
1458|027|H|   Tell your doctor if your condition does not get better or if||
1458|028|H|it gets worse.||
1458|029|B|||
1458|030|S|SIDE EFFECTS:  Headache, breast swelling/tenderness, nausea, or||
1458|031|S|weight changes may occur. If any of these effects last or get||
1458|032|S|worse, tell your doctor or pharmacist promptly.||
1458|033|S|   Remember that this medication has been prescribed because your||
1458|034|S|doctor has judged that the benefit to you is greater than the||
1458|035|S|risk of side effects. Many people using this medication do not||
1458|036|S|have serious side effects.||
1458|037|S|   Tell your doctor right away if you have any serious side||
1458|038|S|effects, including: nausea/vomiting that doesn't stop, yellowing||
1458|039|S|eyes/skin, dark urine, severe stomach/abdominal pain, unusual||
1458|040|S|vaginal bleeding (such as spotting, breakthrough bleeding,||
1458|041|S|prolonged/recurrent bleeding), mental/mood changes (such as||
1458|042|S|depression), swelling hands/ankles/feet.||
1458|043|S|   This medication, especially if used along with an estrogen||
1458|044|S|product, may rarely cause very serious (possibly fatal) problems||
1458|045|S|from blood clots (such as heart attack, stroke, blood clots in||
1458|046|S|the lungs, legs, or eyes). Get medical help right away if you||
1458|047|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
1458|048|S|headaches, weakness on one side of the body, confusion, trouble||
1458|049|S|speaking, sudden vision changes, shortness of breath/rapid||
1458|050|S|breathing, sudden dizziness/fainting, pain/swelling/warmth in the||
1458|051|S|groin/calf.||
1458|052|S|   A very serious allergic reaction to this drug is rare.||
1458|053|S|However, get medical help right away if you notice any symptoms||
1458|054|S|of a serious allergic reaction, including: rash, itching/swelling||
1458|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1458|056|S|breathing.||
1458|057|S|   This is not a complete list of possible side effects. If you||
1458|058|S|notice other effects not listed above, contact your doctor or||
1458|059|S|pharmacist.||
1458|060|S|   In the US -||
1458|061|S|   Call your doctor for medical advice about side effects. You||
1458|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1458|063|S|www.fda.gov/medwatch.||
1458|064|S|   In Canada - Call your doctor for medical advice about side||
1458|065|S|effects. You may report side effects to Health Canada at||
1458|066|S|1-866-234-2345.||
1458|067|B|||
1458|068|P|PRECAUTIONS:  Before taking dienogest, tell your doctor or||
1458|069|P|pharmacist if you are allergic to it; or if you have any other||
1458|070|P|allergies. This product may contain inactive ingredients, which||
1458|071|P|can cause allergic reactions or other problems. Talk to your||
1458|072|P|pharmacist for more details.||
1458|073|P|   Before using this medication, tell your doctor or pharmacist||
1458|074|P|your medical history, especially of: blood clots, heart disease||
1458|075|P|(heart attack, coronary artery disease, heart failure), stroke,||
1458|076|P|diabetes, liver disease, certain cancers (such as breast cancer,||
1458|077|P|cancer of the uterus/ovaries), vaginal bleeding of unknown cause,||
1458|078|P|migraine headaches, family medical history (especially breast||
1458|079|P|lumps, cancer, blood clots), obesity, lupus, high blood pressure,||
1458|080|P|depression, seizures, asthma, kidney disease, high blood||
1458|081|P|cholesterol/triglyceride levels, smoking.||
1458|082|P|   Before having surgery, tell your doctor or dentist about all||
1458|083|P|the products you use (including prescription drugs,||
1458|084|P|nonprescription drugs, and herbal products).||
1458|085|P|   This medication may cause blotchy, dark areas on your face and||
1458|086|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
1458|087|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
1458|088|P|wear protective clothing when outdoors.||
1458|089|P|   This medication should not be used during pregnancy. Consult||
1458|090|P|your doctor for more details and to discuss the use of reliable||
1458|091|P|forms of non-hormonal birth control (such as condoms, diaphragm||
1458|092|P|with spermicide) while taking this medication. If you become||
1458|093|P|pregnant or think you may be pregnant, tell your doctor right||
1458|094|P|away.||
1458|095|P|   It is unknown if this medication passes into breast milk.||
1458|096|P|Because of the possible risk to the infant, breastfeeding is not||
1458|097|P|recommended while using this medication. Consult your doctor||
1458|098|P|before breastfeeding.||
1458|099|B|||
1458|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1458|101|I|medications work or increase your risk for serious side effects.||
1458|102|I|This document does not contain all possible drug interactions.||
1458|103|I|Keep a list of all the products you use (including||
1458|104|I|prescription/nonprescription drugs and herbal products) and share||
1458|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
1458|106|I|the dosage of any medicines without your doctor's approval.||
1458|107|I|   Other medications can affect the removal of dienogest from||
1458|108|I|your body, which may affect how dienogest works. Examples include||
1458|109|I|azole antifungals (such as itraconazole, ketoconazole),||
1458|110|I|rifamycins (such as rifampin), among others.||
1458|111|I|   This medication may interfere with certain lab tests, possibly||
1458|112|I|causing false test results. Make sure lab personnel and all your||
1458|113|I|doctors know you use this drug.||
1458|114|B|||
1458|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1458|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1458|117|O|poison control center right away. US residents can call||
1458|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1458|119|B|||
1458|120|N|NOTES:  Do not share this medication with others.||
1458|121|N|   Regular complete physical exams which include lab and/or||
1458|122|N|medical tests (such as blood pressure, breast exam/mammogram,||
1458|123|N|pelvic exam, Pap smear) should be done while you are taking this||
1458|124|N|medication. Follow your doctor's instructions for examining your||
1458|125|N|breasts, and report any lumps right away. Keep all medical and||
1458|126|N|lab appointments. Consult your doctor for more details.||
1458|127|B|||
1458|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1458|129|D|remember. If it is near the time of the next dose, skip the||
1458|130|D|missed dose. Take your next dose at the regular time. Do not||
1458|131|D|double the dose to catch up.||
1458|132|B|||
1458|133|R|STORAGE:  Store at room temperature away from light and moisture.||
1458|134|R|Do not store in the bathroom. Keep all medications away from||
1458|135|R|children and pets.||
1458|136|R|   Do not flush medications down the toilet or pour them into a||
1458|137|R|drain unless instructed to do so. Properly discard this product||
1458|138|R|when it is expired or no longer needed. Consult your pharmacist||
1458|139|R|or local waste disposal company.||
1458|140|B|||
1458|141|A|Information last revised October 2024.||
1458|142|A|Copyright(c) 2025 First Databank, Inc.||
1458|143|B|||
1459|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1459|002|Z|does NOT have all possible information about this product. This||
1459|003|Z|information does not assure that this product is safe, effective,||
1459|004|Z|or appropriate for you. This information is not individual||
1459|005|Z|medical advice and does not substitute for the advice of your||
1459|006|Z|health care professional. Always ask your health care||
1459|007|Z|professional for complete information about this product and your||
1459|008|Z|specific health needs.||
1459|009|B|||
1459|010|T|BENZOCAINE - MUCOUS MEMBRANE||
1459|011|F|(BEN-zoe-kane)||
1459|012|B|||
1459|013|C|COMMON BRAND NAME(S): Anbesol, HurriCaine||
1459|014|B|||
1459|015|U|USES:  Benzocaine is used short term to relieve pain from minor||
1459|016|U|mouth problems (such as toothache, canker sores, sore||
1459|017|U|gums/throat, mouth/gum injury). It is a local anesthetic that||
1459|018|U|works by numbing the painful area.||
1459|019|U|   Do not use this product for children younger than 2 years due||
1459|020|U|to risk of serious side effects. Ask your doctor for more||
1459|021|U|details.||
1459|022|B|||
1459|023|H|HOW TO USE:  Follow all directions on the product package. If||
1459|024|H|your doctor has prescribed this medication, use it as directed.||
1459|025|H|If you have any questions, ask your doctor or pharmacist.||
1459|026|H|   Do not use this medication more than 4 times a day unless||
1459|027|H|directed by your doctor. Allow medication to stay on painful area||
1459|028|H|for at least 1 minute before spitting out or rinsing the mouth.||
1459|029|H|   Do not use large amounts of this drug or use more often than||
1459|030|H|directed because the risk for serious side effects (including||
1459|031|H|rarely fatal methemoglobinemia) will increase.||
1459|032|H|   Avoid getting this medication in the eyes.||
1459|033|H|   Stop using this medication and tell your doctor if your sore||
1459|034|H|throat is severe or if it lasts for more than 2 days, or if your||
1459|035|H|sore mouth symptoms last more than 7 days, or if you have a||
1459|036|H|fever, headache, rash, swelling, nausea, or vomiting. You may||
1459|037|H|have a serious medical problem that may require different||
1459|038|H|treatment. If your condition lasts or gets worse, or if you think||
1459|039|H|you may have a serious medical problem, get medical help right||
1459|040|H|away.||
1459|041|B|||
1459|042|S|SIDE EFFECTS:  Slight burning, tingling, or stinging may occur.||
1459|043|S|If any of these effects last or get worse, tell your doctor or||
1459|044|S|pharmacist promptly.||
1459|045|S|   If your doctor has directed you to use this medication,||
1459|046|S|remember that your doctor has judged that the benefit to you is||
1459|047|S|greater than the risk of side effects. Many people using this||
1459|048|S|medication do not have serious side effects.||
1459|049|S|   This medication has rarely caused a very serious (possibly||
1459|050|S|fatal) blood disorder (methemoglobinemia). This effect is more||
1459|051|S|likely if you have breathing problems, certain diseases of the||
1459|052|S|blood, or if you smoke (see also Precautions section). The||
1459|053|S|symptoms of this disorder may occur within minutes to a couple of||
1459|054|S|hours after using this medication. Stop using this medication and||
1459|055|S|get medical help right away if you develop any symptoms of||
1459|056|S|methemoglobinemia, including: pale/bluish/gray skin, unusual||
1459|057|S|tiredness, shortness of breath, fast heartbeat, dizziness,||
1459|058|S|headache, confusion.||
1459|059|S|   A very serious allergic reaction to this drug is rare.||
1459|060|S|However, get medical help right away if you notice any symptoms||
1459|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1459|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1459|063|S|breathing.||
1459|064|S|   This is not a complete list of possible side effects. If you||
1459|065|S|notice other effects not listed above, contact your doctor or||
1459|066|S|pharmacist.||
1459|067|S|   In the US -||
1459|068|S|   Call your doctor for medical advice about side effects. You||
1459|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1459|070|S|www.fda.gov/medwatch.||
1459|071|S|   In Canada - Call your doctor for medical advice about side||
1459|072|S|effects. You may report side effects to Health Canada at||
1459|073|S|1-866-234-2345.||
1459|074|B|||
1459|075|P|PRECAUTIONS:  Before using benzocaine, tell your doctor or||
1459|076|P|pharmacist if you are allergic to it; or to other "caine"||
1459|077|P|anesthetics (such as procaine) or if you have any other||
1459|078|P|allergies. This product may contain inactive ingredients, which||
1459|079|P|can cause allergic reactions or other problems. Talk to your||
1459|080|P|pharmacist for more details.||
1459|081|P|   If you have any of the following health problems, consult your||
1459|082|P|doctor or pharmacist before using this product: heart disease,||
1459|083|P|certain blood disorders (G6PD deficiency, pyruvate kinase||
1459|084|P|deficiency, hemoglobin-M disease, NADH-methemoglobin reductase||
1459|085|P|deficiency), breathing problems (such as asthma, bronchitis,||
1459|086|P|emphysema, smoking history).||
1459|087|P|   Before having surgery, tell your doctor or dentist about all||
1459|088|P|the products you use (including prescription drugs,||
1459|089|P|nonprescription drugs, and herbal products).||
1459|090|P|   During pregnancy, this product should be used only when||
1459|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
1459|092|P|   It is unknown if this product passes into breast milk. Consult||
1459|093|P|your doctor before breastfeeding.||
1459|094|B|||
1459|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1459|096|I|medications work or increase your risk for serious side effects.||
1459|097|I|This document does not contain all possible drug interactions.||
1459|098|I|Keep a list of all the products you use (including||
1459|099|I|prescription/nonprescription drugs and herbal products) and share||
1459|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
1459|101|I|the dosage of any medicines without your doctor's approval.||
1459|102|B|||
1459|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1459|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1459|105|O|poison control center right away. US residents can call||
1459|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1459|107|O|Symptoms of overdose may include: slow/shallow breathing,||
1459|108|O|seizures, irregular heartbeat.||
1459|109|B|||
1459|110|N|NOTES:  Keep all medical and lab appointments.||
1459|111|B|||
1459|112|D|MISSED DOSE:  Not applicable.||
1459|113|B|||
1459|114|R|STORAGE:  Store at room temperature. Keep all medications away||
1459|115|R|from children and pets.||
1459|116|R|   Do not flush medications down the toilet or pour them into a||
1459|117|R|drain unless instructed to do so. Properly discard this product||
1459|118|R|when it is expired or no longer needed. Consult your pharmacist||
1459|119|R|or local waste disposal company.||
1459|120|B|||
1459|121|A|Information last revised January 2025.||
1459|122|A|Copyright(c) 2025 First Databank, Inc.||
1459|123|B|||
1460|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1460|002|Z|does NOT have all possible information about this product. This||
1460|003|Z|information does not assure that this product is safe, effective,||
1460|004|Z|or appropriate for you. This information is not individual||
1460|005|Z|medical advice and does not substitute for the advice of your||
1460|006|Z|health care professional. Always ask your health care||
1460|007|Z|professional for complete information about this product and your||
1460|008|Z|specific health needs.||
1460|009|B|||
1460|010|T|AZILSARTAN/CHLORTHALIDONE - ORAL||
1460|011|F|(AY-zil-SAR-tan/klor-THAL-i-done)||
1460|012|B|||
1460|013|C|COMMON BRAND NAME(S): Edarbyclor||
1460|014|B|||
1460|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
1460|016|W|unborn baby if used during pregnancy. It is important to prevent||
1460|017|W|pregnancy while taking this medication. Consult your doctor for||
1460|018|W|more details and to discuss the use of reliable forms of birth||
1460|019|W|control while taking this medication. If you are planning||
1460|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
1460|021|W|your doctor right away.||
1460|022|B|||
1460|023|U|USES:  This medication is used to treat high blood pressure||
1460|024|U|(hypertension). Lowering high blood pressure helps prevent||
1460|025|U|strokes, heart attacks, and kidney problems.||
1460|026|U|   This product contains two medications: azilsartan and||
1460|027|U|chlorthalidone. Azilsartan works by relaxing blood vessels so||
1460|028|U|blood can flow more easily. It belongs to a class of drugs called||
1460|029|U|angiotensin receptor blockers (ARBs). Chlorthalidone causes your||
1460|030|U|body to get rid of extra salt and water by making more urine. It||
1460|031|U|is called a "water pill" or diuretic.||
1460|032|B|||
1460|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1460|034|H|from your pharmacist before you start taking this product and||
1460|035|H|each time you get a refill. If you have any questions, ask your||
1460|036|H|doctor or pharmacist.||
1460|037|H|   Take this medication by mouth with or without food as directed||
1460|038|H|by your doctor, usually once daily. If you take this drug too||
1460|039|H|close to bedtime, you may need to wake up to urinate. It is best||
1460|040|H|to take this medication at least 4 hours before your bedtime.||
1460|041|H|   The dosage is based on your medical condition and response to||
1460|042|H|treatment.||
1460|043|H|   Take this medication regularly to get the most benefit from||
1460|044|H|it. To help you remember, take it at the same time each day. Keep||
1460|045|H|taking this medication even if you feel well. Most people with||
1460|046|H|high blood pressure do not feel sick. It may take several weeks||
1460|047|H|before you get the full benefit of this drug.||
1460|048|H|   If you also take certain drugs to lower your cholesterol (bile||
1460|049|H|acid-binding resins such as cholestyramine, colestipol), take||
1460|050|H|azilsartan/chlorthalidone at least 2 hours before or at least 4||
1460|051|H|hours after these medications.||
1460|052|H|   Tell your doctor if your condition does not get better or if||
1460|053|H|it gets worse (your blood pressure readings remain high or||
1460|054|H|increase).||
1460|055|B|||
1460|056|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
1460|057|S|body adjusts to the medication. If either of these effects lasts||
1460|058|S|or gets worse, tell your doctor or pharmacist promptly.||
1460|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
1460|060|S|slowly when rising from a sitting or lying position.||
1460|061|S|   Remember that this medication has been prescribed because your||
1460|062|S|doctor has judged that the benefit to you is greater than the||
1460|063|S|risk of side effects. Many people using this medication do not||
1460|064|S|have serious side effects.||
1460|065|S|   This product may cause dehydration and electrolyte imbalance.||
1460|066|S|Tell your doctor right away if you have any symptoms of||
1460|067|S|dehydration or electrolyte imbalance, including unusual dry||
1460|068|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
1460|069|S|heartbeat, or confusion.||
1460|070|S|   Tell your doctor right away if you have any serious side||
1460|071|S|effects, including: fainting, severe tiredness, big toe/joint||
1460|072|S|pain, symptoms of a high potassium blood level (such as muscle||
1460|073|S|weakness, slow/irregular heartbeat), signs of kidney problems||
1460|074|S|(such as change in the amount of urine).||
1460|075|S|   Get medical help right away if you have any very serious side||
1460|076|S|effects, including: decrease in vision, eye pain.||
1460|077|S|   A very serious allergic reaction to this drug is rare.||
1460|078|S|However, get medical help right away if you notice any symptoms||
1460|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1460|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1460|081|S|breathing.||
1460|082|S|   This is not a complete list of possible side effects. If you||
1460|083|S|notice other effects not listed above, contact your doctor or||
1460|084|S|pharmacist.||
1460|085|S|   In the US -||
1460|086|S|   Call your doctor for medical advice about side effects. You||
1460|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1460|088|S|www.fda.gov/medwatch.||
1460|089|S|   In Canada - Call your doctor for medical advice about side||
1460|090|S|effects. You may report side effects to Health Canada at||
1460|091|S|1-866-234-2345.||
1460|092|B|||
1460|093|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1460|094|P|pharmacist if you are allergic to azilsartan or chlorthalidone;||
1460|095|P|or if you have any other allergies. This product may contain||
1460|096|P|inactive ingredients which can cause allergic reactions or other||
1460|097|P|problems. Talk to your pharmacist for more details.||
1460|098|P|   Before using this medication, tell your doctor or pharmacist||
1460|099|P|your medical history, especially of: kidney disease, liver||
1460|100|P|disease, dehydration, untreated mineral imbalance (such as||
1460|101|P|high/low potassium, low magnesium, high calcium, low sodium),||
1460|102|P|gout, lupus.||
1460|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1460|104|P|can make you more dizzy. Do not drive, use machinery, or do||
1460|105|P|anything that needs alertness until you can do it safely. Limit||
1460|106|P|alcoholic beverages. Talk to your doctor if you are using||
1460|107|P|marijuana (cannabis).||
1460|108|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1460|109|P|and cause you to feel lightheaded. Tell your doctor if you have||
1460|110|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1460|111|P|of fluids unless your doctor tells you not to.||
1460|112|P|   If you have diabetes, this product may affect your blood||
1460|113|P|sugar. Check your blood sugar regularly as directed and share the||
1460|114|P|results with your doctor. Your doctor may need to adjust your||
1460|115|P|diabetes medication, exercise program, or diet.||
1460|116|P|   This product may affect your potassium levels. Before using||
1460|117|P|potassium supplements or salt substitutes that contain potassium,||
1460|118|P|consult your doctor or pharmacist.||
1460|119|P|   This medication may make you more sensitive to the sun. Limit||
1460|120|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1460|121|P|sunscreen and wear protective clothing when outdoors. Tell your||
1460|122|P|doctor right away if you get sunburned or have skin||
1460|123|P|blisters/redness.||
1460|124|P|   Before having surgery, tell your doctor or dentist about all||
1460|125|P|the products you use (including prescription drugs,||
1460|126|P|nonprescription drugs, and herbal products).||
1460|127|P|   Older adults may be more sensitive to the side effects of this||
1460|128|P|drug, especially dizziness and change in the amount of urine||
1460|129|P|(kidney problems).||
1460|130|P|   Tell your doctor if you are pregnant or plan to become||
1460|131|P|pregnant. You should not become pregnant while using this||
1460|132|P|medication. Azilsartan may harm an unborn baby. If you become||
1460|133|P|pregnant, talk to your doctor right away about the risks and||
1460|134|P|benefits of this medication. See also Warning section.||
1460|135|P|   It is unknown if azilsartan passes into breast milk.||
1460|136|P|Chlorthalidone passes into breast milk. Consult your doctor||
1460|137|P|before breastfeeding.||
1460|138|B|||
1460|139|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
1460|140|I|   Drug interactions may change how your medications work or||
1460|141|I|increase your risk for serious side effects. This document does||
1460|142|I|not contain all possible drug interactions. Keep a list of all||
1460|143|I|the products you use (including prescription/nonprescription||
1460|144|I|drugs and herbal products) and share it with your doctor and||
1460|145|I|pharmacist. Do not start, stop, or change the dosage of any||
1460|146|I|medicines without your doctor's approval.||
1460|147|I|   Some products that may interact with this drug include:||
1460|148|I|aliskiren, dofetilide, lithium, drugs that may increase the level||
1460|149|I|of potassium in the blood (such as sparsentan, ACE inhibitors||
1460|150|I|including benazepril/lisinopril, birth control pills containing||
1460|151|I|drospirenone).||
1460|152|I|   Some products have ingredients that could raise your blood||
1460|153|I|pressure. Tell your pharmacist what products you are using, and||
1460|154|I|ask how to use them safely (especially cough-and-cold products,||
1460|155|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1460|156|I|   This medication may interfere with certain lab tests, possibly||
1460|157|I|causing false test results. Make sure lab personnel and all your||
1460|158|I|doctors know you use this drug.||
1460|159|B|||
1460|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1460|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1460|162|O|poison control center right away. US residents can call||
1460|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1460|164|O|Symptoms of overdose may include: severe dizziness, fainting.||
1460|165|B|||
1460|166|N|NOTES:  Do not share this medication with others.||
1460|167|N|   Lifestyle changes that may help this medication work better||
1460|168|N|include exercising, stopping smoking, and eating a||
1460|169|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1460|170|N|details.||
1460|171|N|   Lab and/or medical tests (including kidney function, blood||
1460|172|N|mineral levels such as potassium) should be done while you are||
1460|173|N|taking this medication. Keep all medical and lab appointments.||
1460|174|N|Consult your doctor for more details.||
1460|175|N|   Have your blood pressure checked regularly while taking this||
1460|176|N|medication. Learn how to monitor your own blood pressure at home,||
1460|177|N|and share the results with your doctor.||
1460|178|B|||
1460|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1460|180|D|remember. If it is near the time of the next dose, skip the||
1460|181|D|missed dose. Take your next dose at the regular time. Do not||
1460|182|D|double the dose to catch up.||
1460|183|B|||
1460|184|R|STORAGE:  Store in the original container at room temperature||
1460|185|R|away from light and moisture. Do not store in the bathroom. Keep||
1460|186|R|all medications away from children and pets.||
1460|187|R|   Do not flush medications down the toilet or pour them into a||
1460|188|R|drain unless instructed to do so. Properly discard this product||
1460|189|R|when it is expired or no longer needed. Consult your pharmacist||
1460|190|R|or local waste disposal company.||
1460|191|B|||
1460|192|A|Information last revised May 2024.||
1460|193|A|Copyright(c) 2025 First Databank, Inc.||
1460|194|B|||
1462|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1462|002|Z|does NOT have all possible information about this product. This||
1462|003|Z|information does not assure that this product is safe, effective,||
1462|004|Z|or appropriate for you. This information is not individual||
1462|005|Z|medical advice and does not substitute for the advice of your||
1462|006|Z|health care professional. Always ask your health care||
1462|007|Z|professional for complete information about this product and your||
1462|008|Z|specific health needs.||
1462|009|B|||
1462|010|T|GONADORELIN - INJECTION||
1462|011|F|(goe-NAD-oh-REL-in)||
1462|012|B|||
1462|013|W|WARNING:  This medication may rarely cause a condition known as||
1462|014|W|ovarian hyperstimulation syndrome (OHSS). This condition may||
1462|015|W|occur during or after treatment. Rarely, serious OHSS causes||
1462|016|W|fluid to suddenly build up in the stomach, chest, and heart area.||
1462|017|W|Get medical help right away if you develop the following side||
1462|018|W|effects: severe pain or swelling in the lower abdominal (pelvic)||
1462|019|W|area, severe nausea/vomiting, diarrhea, sudden/rapid weight gain,||
1462|020|W|difficulty breathing or decreased urination. Discuss the risks||
1462|021|W|and benefits of this medication with your doctor. Keep all||
1462|022|W|medical and lab appointments.||
1462|023|B|||
1462|024|U|USES:  Gonadorelin is used by women who are missing menstrual||
1462|025|U|periods due to low levels of gonadotropin-releasing hormone||
1462|026|U|(GnRH). It may be used as part of female infertility treatment.||
1462|027|U|This medication provides GnRH that the body needs for the growth||
1462|028|U|and release of mature eggs from the ovaries (ovulation).||
1462|029|B|||
1462|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1462|031|H|from your pharmacist before you start using gonadorelin and each||
1462|032|H|time you get a refill. If you have any questions, ask your doctor||
1462|033|H|or pharmacist.||
1462|034|H|   Gonadorelin is injected into a vein or under the skin using an||
1462|035|H|infusion pump, as directed by your doctor. The dosage is based on||
1462|036|H|your medical condition and response to treatment. Keep all||
1462|037|H|medical appointments so your doctor can closely monitor your||
1462|038|H|response and adjust your dosage if necessary. Do not change the||
1462|039|H|dose unless directed by your doctor, and do not use this||
1462|040|H|medication for a longer period than prescribed.||
1462|041|H|   If you are using this medication at home, learn all||
1462|042|H|preparation and usage instructions from your health care||
1462|043|H|professional and the medication package. Follow all instructions||
1462|044|H|for using the infusion pump. Do not mix this medication until you||
1462|045|H|are ready to use it. Before using this medication, check the||
1462|046|H|solution for particles or discoloration. If either is present, do||
1462|047|H|not use the solution. Before each dose, clean the injection site||
1462|048|H|with rubbing alcohol. If you are injecting the medication under||
1462|049|H|the skin, change the injection site as directed by your doctor to||
1462|050|H|lessen injury under the skin. If you are injecting the medication||
1462|051|H|into a vein, you do not need to change the injection site unless||
1462|052|H|directed by your doctor. Learn how to store and discard medical||
1462|053|H|supplies safely.||
1462|054|H|   Tell your doctor if your condition does not get better.||
1462|055|B|||
1462|056|S|SIDE EFFECTS:  See also Warning section.||
1462|057|S|   Headache, nausea, and mild abdominal pain may occur with||
1462|058|S|menstrual bleeding. Injection site reactions (such as mild||
1462|059|S|irritation, redness, bruising) may occur. If any of these effects||
1462|060|S|last or get worse, tell your doctor or pharmacist promptly.||
1462|061|S|   Remember that this medication has been prescribed because your||
1462|062|S|doctor has judged that the benefit to you is greater than the||
1462|063|S|risk of side effects. Many people using this medication do not||
1462|064|S|have serious side effects.||
1462|065|S|   Tell your doctor right away if you have any serious side||
1462|066|S|effects, including: mental/mood changes (such as depression,||
1462|067|S|agitation), signs of infection (such as||
1462|068|S|redness/pain/swelling/warmth at the injection site that doesn't||
1462|069|S|go away, fever, chills).||
1462|070|S|   A very serious allergic reaction to this drug is rare.||
1462|071|S|However, get medical help right away if you notice any symptoms||
1462|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1462|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1462|074|S|breathing.||
1462|075|S|   This is not a complete list of possible side effects. If you||
1462|076|S|notice other effects not listed above, contact your doctor or||
1462|077|S|pharmacist.||
1462|078|S|   In the US -||
1462|079|S|   Call your doctor for medical advice about side effects. You||
1462|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1462|081|S|www.fda.gov/medwatch.||
1462|082|S|   In Canada - Call your doctor for medical advice about side||
1462|083|S|effects. You may report side effects to Health Canada at||
1462|084|S|1-866-234-2345.||
1462|085|B|||
1462|086|P|PRECAUTIONS:  Before using gonadorelin, tell your doctor or||
1462|087|P|pharmacist if you are allergic to it; or if you have any other||
1462|088|P|allergies. This product may contain inactive ingredients, which||
1462|089|P|can cause allergic reactions or other problems. Talk to your||
1462|090|P|pharmacist for more details.||
1462|091|P|   Before using this medication, tell your doctor or pharmacist||
1462|092|P|your medical history, especially of: ovarian cysts, kidney||
1462|093|P|disease, tumors of the pituitary gland (such as prolactinoma),||
1462|094|P|cancer of the reproductive organs (such as ovary, breast,||
1462|095|P|uterus), mental/mood problems (such as depression).||
1462|096|P|   Before having surgery, tell your doctor or dentist about all||
1462|097|P|the products you use (including prescription drugs,||
1462|098|P|nonprescription drugs, and herbal products).||
1462|099|P|   Use of gonadorelin may cause multiple births (such as twins,||
1462|100|P|triplets). Discuss the risks and benefits of having such a||
1462|101|P|pregnancy with your doctor.||
1462|102|P|   This medication may be used during the first trimester of||
1462|103|P|pregnancy as directed by your doctor. Tell your doctor right away||
1462|104|P|if you become pregnant or think you may be pregnant. Consult your||
1462|105|P|doctor for more details.||
1462|106|P|   It is unknown if gonadorelin passes into breast milk. This||
1462|107|P|medication is usually not used by nursing women. Consult your||
1462|108|P|doctor before breastfeeding.||
1462|109|B|||
1462|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1462|111|I|medications work or increase your risk for serious side effects.||
1462|112|I|This document does not contain all possible drug interactions.||
1462|113|I|Keep a list of all the products you use (including||
1462|114|I|prescription/nonprescription drugs and herbal products) and share||
1462|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
1462|116|I|the dosage of any medicines without your doctor's approval.||
1462|117|I|   Some products that may interact with this drug include: other||
1462|118|I|medications that cause ovulation.||
1462|119|B|||
1462|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1462|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1462|122|O|poison control center right away. US residents can call||
1462|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1462|124|B|||
1462|125|N|NOTES:  Do not share this medication with others.||
1462|126|N|   Lab and medical tests (such as blood hormone levels for||
1462|127|N|estradiol/progesterone, ultrasounds) should be done while you are||
1462|128|N|using this medication. Your doctor may ask you to monitor your||
1462|129|N|body temperature. Keep all medical and lab appointments. Consult||
1462|130|N|your doctor for more details.||
1462|131|B|||
1462|132|D|MISSED DOSE:  It is important to get each dose of this medication||
1462|133|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1462|134|D|right away for a new dosing schedule. Do not double the dose to||
1462|135|D|catch up.||
1462|136|B|||
1462|137|R|STORAGE:  Store at room temperature. Keep all medications away||
1462|138|R|from children and pets.||
1462|139|R|   Do not flush medications down the toilet or pour them into a||
1462|140|R|drain unless instructed to do so. Properly discard this product||
1462|141|R|when it is expired or no longer needed. Consult your pharmacist||
1462|142|R|or local waste disposal company.||
1462|143|B|||
1462|144|A|Information last revised December 2024.||
1462|145|A|Copyright(c) 2025 First Databank, Inc.||
1462|146|B|||
1463|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1463|002|Z|does NOT have all possible information about this product. This||
1463|003|Z|information does not assure that this product is safe, effective,||
1463|004|Z|or appropriate for you. This information is not individual||
1463|005|Z|medical advice and does not substitute for the advice of your||
1463|006|Z|health care professional. Always ask your health care||
1463|007|Z|professional for complete information about this product and your||
1463|008|Z|specific health needs.||
1463|009|B|||
1463|010|T|IVACAFTOR - ORAL||
1463|011|F|(EYE-va-KAF-tor)||
1463|012|B|||
1463|013|C|COMMON BRAND NAME(S): Kalydeco||
1463|014|B|||
1463|015|U|USES:  This medication is used to treat cystic fibrosis in||
1463|016|U|certain people (those with an abnormal "CFTR" gene). It may help||
1463|017|U|to improve breathing, reduce the risk of lung infections, and||
1463|018|U|improve weight gain.||
1463|019|B|||
1463|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1463|021|H|from your pharmacist before you start taking ivacaftor and each||
1463|022|H|time you get a refill. If you have any questions, ask your doctor||
1463|023|H|or pharmacist.||
1463|024|H|   Take this medication by mouth as directed by your doctor,||
1463|025|H|usually twice daily (every 12 hours).||
1463|026|H|   If you are taking the tablet form of this medication, take||
1463|027|H|this medication with fat-containing foods (such as eggs, butter,||
1463|028|H|peanut butter, cheese). The manufacturer directs to swallow this||
1463|029|H|medication whole. However, many similar drugs (immediate-release||
1463|030|H|tablets) can be split/crushed. Follow your doctor's directions on||
1463|031|H|how to take this medication.||
1463|032|H|   If you are taking the granules form of this medication, gently||
1463|033|H|shake the packet before use. Empty the packet into a small cup||
1463|034|H|with 1 teaspoonful (5 milliliters) of soft food (such as yogurt,||
1463|035|H|applesauce) or liquid (such as water, milk, infant formula). The||
1463|036|H|soft food or liquid should be at or below room temperature. Mix||
1463|037|H|the granules with the soft food or liquid and take the entire||
1463|038|H|mixture within 1 hour of mixing. Eat a fat-containing food either||
1463|039|H|right before or just after taking the mixture.||
1463|040|H|   The dosage is based on your medical condition, age, weight,||
1463|041|H|response to treatment, and other medications you may be taking.||
1463|042|H|Be sure to tell your doctor and pharmacist about all the products||
1463|043|H|you use (including prescription drugs, nonprescription drugs, and||
1463|044|H|herbal products).||
1463|045|H|   Use this medication regularly to get the most benefit from it.||
1463|046|H|To help you remember, take it at the same time(s) each day.||
1463|047|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1463|048|H|using this medication unless your doctor or pharmacist says you||
1463|049|H|may do so safely. Grapefruit can increase the chance of side||
1463|050|H|effects with this medicine. Ask your doctor or pharmacist for||
1463|051|H|more details.||
1463|052|H|   Tell your doctor if your condition does not get better or if||
1463|053|H|it gets worse.||
1463|054|B|||
1463|055|S|SIDE EFFECTS:  Dizziness, headache, or nausea may occur. If any||
1463|056|S|of these effects last or get worse, tell your doctor or||
1463|057|S|pharmacist promptly.||
1463|058|S|   Remember that this medication has been prescribed because your||
1463|059|S|doctor has judged that the benefit to you is greater than the||
1463|060|S|risk of side effects. Many people using this medication do not||
1463|061|S|have serious side effects.||
1463|062|S|   This medication may rarely cause increased pressure around the||
1463|063|S|brain (intracranial hypertension-IH). Get medical help right away||
1463|064|S|if any of these very serious side effects occur: headache that is||
1463|065|S|severe or doesn't go away, vision changes (such as blurred/double||
1463|066|S|vision, decreased vision).||
1463|067|S|   Ivacaftor may rarely cause serious liver disease. Get medical||
1463|068|S|help right away if you have any symptoms of liver damage,||
1463|069|S|including: nausea/vomiting that doesn't stop, loss of appetite,||
1463|070|S|dark urine, stomach/abdominal pain, yellowing eyes/skin.||
1463|071|S|   Ivacaftor can commonly cause a rash that is usually not||
1463|072|S|serious. However, you may not be able to tell it apart from a||
1463|073|S|rare rash that could be a sign of a severe reaction. Tell your||
1463|074|S|doctor right away if you develop any rash.||
1463|075|S|   A very serious allergic reaction to this drug is rare.||
1463|076|S|However, get medical help right away if you notice any symptoms||
1463|077|S|of a serious allergic reaction, including: rash, itching/swelling||
1463|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1463|079|S|breathing.||
1463|080|S|   This is not a complete list of possible side effects. If you||
1463|081|S|notice other effects not listed above, contact your doctor or||
1463|082|S|pharmacist.||
1463|083|S|   In the US -||
1463|084|S|   Call your doctor for medical advice about side effects. You||
1463|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1463|086|S|www.fda.gov/medwatch.||
1463|087|S|   In Canada - Call your doctor for medical advice about side||
1463|088|S|effects. You may report side effects to Health Canada at||
1463|089|S|1-866-234-2345.||
1463|090|B|||
1463|091|P|PRECAUTIONS:  Before taking ivacaftor, tell your doctor or||
1463|092|P|pharmacist if you are allergic to it; or if you have any other||
1463|093|P|allergies. This product may contain inactive ingredients, which||
1463|094|P|can cause allergic reactions or other problems. Talk to your||
1463|095|P|pharmacist for more details.||
1463|096|P|   Before using this medication, tell your doctor or pharmacist||
1463|097|P|your medical history, especially of: liver disease.||
1463|098|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1463|099|P|can make you more dizzy. Do not drive, use machinery, or do||
1463|100|P|anything that needs alertness until you can do it safely. Limit||
1463|101|P|alcoholic beverages. Talk to your doctor if you are using||
1463|102|P|marijuana (cannabis).||
1463|103|P|   Before having surgery, tell your doctor or dentist about all||
1463|104|P|the products you use (including prescription drugs,||
1463|105|P|nonprescription drugs, and herbal products).||
1463|106|P|   During pregnancy, this medication should be used only when||
1463|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
1463|108|P|   This medication passes into breast milk. Consult your doctor||
1463|109|P|before breastfeeding.||
1463|110|B|||
1463|111|I|DRUG INTERACTIONS:  See also How To Use section.||
1463|112|I|   Drug interactions may change how your medications work or||
1463|113|I|increase your risk for serious side effects. This document does||
1463|114|I|not contain all possible drug interactions. Keep a list of all||
1463|115|I|the products you use (including prescription/nonprescription||
1463|116|I|drugs and herbal products) and share it with your doctor and||
1463|117|I|pharmacist. Do not start, stop, or change the dosage of any||
1463|118|I|medicines without your doctor's approval.||
1463|119|I|   Other medications can affect the removal of ivacaftor from||
1463|120|I|your body, which may affect how ivacaftor works. Examples include||
1463|121|I|mifepristone, rifamycins (such as rifabutin), drugs for seizures||
1463|122|I|(such as carbamazepine, phenytoin), St. John's wort, among||
1463|123|I|others.||
1463|124|B|||
1463|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1463|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1463|127|O|poison control center right away. US residents can call||
1463|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1463|129|B|||
1463|130|N|NOTES:  Do not share this medication with others.||
1463|131|N|   Lab and/or medical tests (such as CFTR gene testing,||
1463|132|N|liver/lung function, eye exams) will be done before you start||
1463|133|N|taking this medication and while you are taking it. Keep all||
1463|134|N|medical and lab appointments. Consult your doctor for more||
1463|135|N|details.||
1463|136|B|||
1463|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1463|138|D|remember. If it is more than 6 hours after the missed dose, skip||
1463|139|D|the missed dose. Take your next dose at the regular time. Do not||
1463|140|D|double the dose to catch up.||
1463|141|B|||
1463|142|R|STORAGE:  Store at room temperature away from light and moisture.||
1463|143|R|Do not store in the bathroom. Keep all medications away from||
1463|144|R|children and pets.||
1463|145|R|   Do not flush medications down the toilet or pour them into a||
1463|146|R|drain unless instructed to do so. Properly discard this product||
1463|147|R|when it is expired or no longer needed. Consult your pharmacist||
1463|148|R|or local waste disposal company.||
1463|149|B|||
1463|150|A|Information last revised September 2025.||
1463|151|A|Copyright(c) 2025 First Databank, Inc.||
1463|152|B|||
1464|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1464|002|Z|does NOT have all possible information about this product. This||
1464|003|Z|information does not assure that this product is safe, effective,||
1464|004|Z|or appropriate for you. This information is not individual||
1464|005|Z|medical advice and does not substitute for the advice of your||
1464|006|Z|health care professional. Always ask your health care||
1464|007|Z|professional for complete information about this product and your||
1464|008|Z|specific health needs.||
1464|009|B|||
1464|010|T|VISMODEGIB - ORAL||
1464|011|F|(VIS-moe-DEG-ib)||
1464|012|B|||
1464|013|C|COMMON BRAND NAME(S): Erivedge||
1464|014|B|||
1464|015|W|WARNING:  Vismodegib must not be used during pregnancy because it||
1464|016|W|may cause serious harm (possibly death) to an unborn baby. Women||
1464|017|W|of childbearing age must have a negative pregnancy test within 7||
1464|018|W|days before starting this medication. They must also use a||
1464|019|W|reliable form of birth control before starting vismodegib, while||
1464|020|W|taking it, and for 2 years after the last dose of vismodegib.||
1464|021|W|   Vismodegib passes into semen. Men taking vismodegib, even men||
1464|022|W|who have had a vasectomy, must use condoms with spermicide during||
1464|023|W|sex with women who are pregnant or of childbearing age, both||
1464|024|W|during treatment with vismodegib and for 3 months after the last||
1464|025|W|dose of this medication. Men should also not donate sperm during||
1464|026|W|this time.||
1464|027|W|   If you or your partner become pregnant or think you may be||
1464|028|W|pregnant, tell your doctor right away.||
1464|029|B|||
1464|030|U|USES:  This medication is used to treat adults with a certain||
1464|031|U|type of skin cancer (basal cell carcinoma).||
1464|032|B|||
1464|033|H|HOW TO USE:  Read the Medication Guide provided by your||
1464|034|H|pharmacist before you start taking vismodegib and each time you||
1464|035|H|get a refill. If you have any questions, ask your doctor or||
1464|036|H|pharmacist.||
1464|037|H|   Take this medication by mouth with or without food as directed||
1464|038|H|by your doctor, usually once daily. Swallow the capsules whole.||
1464|039|H|Do not crush or chew the capsules.||
1464|040|H|   Use this medication regularly to get the most benefit from it.||
1464|041|H|To help you remember, take it at the same time each day.||
1464|042|H|   Tell your doctor if your condition lasts or gets worse.||
1464|043|H|   Since this drug can be absorbed through the skin and lungs and||
1464|044|H|may harm an unborn baby, women who are pregnant or who may become||
1464|045|H|pregnant should not handle this medication or breathe the dust||
1464|046|H|from the capsules.||
1464|047|B|||
1464|048|S|SIDE EFFECTS:  Muscle spasms, hair loss, taste changes/loss,||
1464|049|S|weight loss, tiredness, nausea, diarrhea, loss of appetite,||
1464|050|S|constipation, vomiting, or joint pain may occur. If any of these||
1464|051|S|effects last or get worse, tell your doctor or pharmacist||
1464|052|S|promptly.||
1464|053|S|   Remember that this medication has been prescribed because your||
1464|054|S|doctor has judged that the benefit to you is greater than the||
1464|055|S|risk of side effects. Many people using this medication do not||
1464|056|S|have serious side effects.||
1464|057|S|   Tell your doctor right away if you have any serious side||
1464|058|S|effects, including: missed periods.||
1464|059|S|   A very serious allergic reaction to this drug is rare.||
1464|060|S|However, get medical help right away if you notice any symptoms||
1464|061|S|of a serious allergic reaction, including: fever, swollen lymph||
1464|062|S|nodes, rash, itching/swelling (especially of the||
1464|063|S|face/tongue/throat), severe dizziness, trouble breathing.||
1464|064|S|   This is not a complete list of possible side effects. If you||
1464|065|S|notice other effects not listed above, contact your doctor or||
1464|066|S|pharmacist.||
1464|067|S|   In the US -||
1464|068|S|   Call your doctor for medical advice about side effects. You||
1464|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1464|070|S|www.fda.gov/medwatch.||
1464|071|S|   In Canada - Call your doctor for medical advice about side||
1464|072|S|effects. You may report side effects to Health Canada at||
1464|073|S|1-866-234-2345.||
1464|074|B|||
1464|075|P|PRECAUTIONS:  Before taking vismodegib, tell your doctor or||
1464|076|P|pharmacist if you are allergic to it; or if you have any other||
1464|077|P|allergies. This product may contain inactive ingredients, which||
1464|078|P|can cause allergic reactions or other problems. Talk to your||
1464|079|P|pharmacist for more details.||
1464|080|P|   Before using this medication, tell your doctor or pharmacist||
1464|081|P|your medical history.||
1464|082|P|   Before having surgery, tell your doctor or dentist about all||
1464|083|P|the products you use (including prescription drugs,||
1464|084|P|nonprescription drugs, and herbal products).||
1464|085|P|   Do not donate blood while taking this drug and for 2 years||
1464|086|P|after stopping treatment. This will prevent the possibility of||
1464|087|P|your blood being given to a pregnant woman.||
1464|088|P|   This medication may stop normal bone growth and affect final||
1464|089|P|height, or bring on early puberty, if it is used by||
1464|090|P|children/young adults. Ask your doctor for more details.||
1464|091|P|   This medication must not be used during pregnancy. It may harm||
1464|092|P|an unborn baby. Discuss the use of reliable forms of birth||
1464|093|P|control (such as condoms, birth control pills) with your doctor.||
1464|094|P|If you become pregnant or think you may be pregnant, tell your||
1464|095|P|doctor right away. (See also Warning section.)||
1464|096|P|   Since this drug can be absorbed through the skin and lungs and||
1464|097|P|may harm an unborn baby, women who are pregnant or who may become||
1464|098|P|pregnant should not handle this medication or breathe the dust||
1464|099|P|from the capsules.||
1464|100|P|   It is unknown if this medication passes into breast milk.||
1464|101|P|Because of the possible risk to the infant, breastfeeding is not||
1464|102|P|recommended while using this medication and for 2 years after the||
1464|103|P|last dose. Consult your doctor before breastfeeding.||
1464|104|B|||
1464|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1464|106|I|medications work or increase your risk for serious side effects.||
1464|107|I|This document does not contain all possible drug interactions.||
1464|108|I|Keep a list of all the products you use (including||
1464|109|I|prescription/nonprescription drugs and herbal products) and share||
1464|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
1464|111|I|the dosage of any medicines without your doctor's approval.||
1464|112|B|||
1464|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1464|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1464|115|O|poison control center right away. US residents can call||
1464|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1464|117|B|||
1464|118|N|NOTES:  Do not share this medication with others.||
1464|119|N|   Lab and/or medical tests (such as creatine kinase levels) must||
1464|120|N|be done before you start taking this medication and while you are||
1464|121|N|taking it. Keep all medical and lab appointments. Consult your||
1464|122|N|doctor for more details.||
1464|123|B|||
1464|124|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1464|125|D|next dose at the regular time. Do not double the dose to catch||
1464|126|D|up.||
1464|127|B|||
1464|128|R|STORAGE:  Store at room temperature away from light and moisture.||
1464|129|R|Do not store in the bathroom. Keep all medications away from||
1464|130|R|children and pets.||
1464|131|R|   Do not flush medications down the toilet or pour them into a||
1464|132|R|drain unless instructed to do so. Properly discard this product||
1464|133|R|when it is expired or no longer needed. Consult your pharmacist||
1464|134|R|or local waste disposal company.||
1464|135|B|||
1464|136|A|Information last revised May 2024.||
1464|137|A|Copyright(c) 2025 First Databank, Inc.||
1464|138|B|||
1465|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1465|002|Z|does NOT have all possible information about this product. This||
1465|003|Z|information does not assure that this product is safe, effective,||
1465|004|Z|or appropriate for you. This information is not individual||
1465|005|Z|medical advice and does not substitute for the advice of your||
1465|006|Z|health care professional. Always ask your health care||
1465|007|Z|professional for complete information about this product and your||
1465|008|Z|specific health needs.||
1465|009|B|||
1465|010|T|EXENATIDE EXTENDED-RELEASE - INJECTION||
1465|011|F|(ex-EN-a-tide)||
1465|012|B|||
1465|013|C|COMMON BRAND NAME(S): Bydureon||
1465|014|B|||
1465|015|W|WARNING:  This medication can cause a certain type of thyroid||
1465|016|W|tumor (thyroid C-cell tumors) in rats. It is unknown if this||
1465|017|W|medication can cause similar tumors in humans. Talk with your||
1465|018|W|doctor about the benefits and risks of treatment with this||
1465|019|W|medication. Do not use this medication if you have a||
1465|020|W|personal/family history of a certain type of cancer (medullary||
1465|021|W|thyroid carcinoma) or a certain inherited disease (multiple||
1465|022|W|endocrine neoplasia syndrome type 2 or MEN 2). While using this||
1465|023|W|medication, tell your doctor right away if you notice any signs||
1465|024|W|of thyroid tumors, including an unusual growth or lump in the||
1465|025|W|neck, difficulty swallowing, shortness of breath, unusual/lasting||
1465|026|W|hoarseness.||
1465|027|B|||
1465|028|U|USES:  Exenatide is used either alone or with other medications,||
1465|029|U|and with a proper diet and exercise program, to control high||
1465|030|U|blood sugar in people with type 2 diabetes. Controlling high||
1465|031|U|blood sugar helps prevent kidney damage, blindness, nerve||
1465|032|U|problems, loss of limbs, and sexual function problems. Proper||
1465|033|U|control of diabetes may also lessen your risk of a heart attack||
1465|034|U|or stroke.||
1465|035|U|   Exenatide is similar to a natural hormone in your body||
1465|036|U|(incretin). It works by causing insulin release in response to||
1465|037|U|high sugar (such as after a meal) and decreasing the amount of||
1465|038|U|sugar your liver makes.||
1465|039|U|   Exenatide is not a substitute for insulin if you require||
1465|040|U|insulin treatment.||
1465|041|B|||
1465|042|H|HOW TO USE:  Read the Medication Guide and the Instructions For||
1465|043|H|Use Leaflet provided by your pharmacist before you start using||
1465|044|H|exenatide and each time you get a refill. Ask your health care||
1465|045|H|professional how to prepare and use this medication. If you have||
1465|046|H|any questions, ask your doctor or pharmacist.||
1465|047|H|   Inject this medication under the skin as directed by your||
1465|048|H|doctor, usually once every 7 days. It may be used with or without||
1465|049|H|meals. The injection is given in the thigh, abdomen, or upper||
1465|050|H|arm.||
1465|051|H|   Before using, check this product for particles or||
1465|052|H|discoloration. If either is present, do not use the liquid.||
1465|053|H|Before injecting each dose, clean the skin you are going to||
1465|054|H|inject into (the injection site) with rubbing alcohol. Change the||
1465|055|H|injection site each time to lessen injury under the skin. If you||
1465|056|H|are using insulin at the same time as exenatide, give exenatide||
1465|057|H|and insulin as separate injections. Do not mix them. You may||
1465|058|H|inject these medications in the same area of the body, but the||
1465|059|H|injection sites should not be next to each other. To lessen||
1465|060|H|bruising, do not rub the injection site after a shot. Learn how||
1465|061|H|to store and discard medical supplies safely.||
1465|062|H|   Use this medication regularly to get the most benefit from it.||
1465|063|H|To help you remember, use it on the same day each week. Mark your||
1465|064|H|calendar with a reminder. Carefully follow the medication||
1465|065|H|treatment plan, meal plan, and exercise program your doctor has||
1465|066|H|recommended.||
1465|067|H|   Tell your doctor if your condition does not get better or if||
1465|068|H|it gets worse (your blood sugar is too high or too low).||
1465|069|B|||
1465|070|S|SIDE EFFECTS:  See also Warning section.||
1465|071|S|   Swelling/redness/itching at the injection site, tiredness,||
1465|072|S|nausea, vomiting, diarrhea, constipation, or stomach upset may||
1465|073|S|occur. Nausea usually lessens as you continue to use exenatide.||
1465|074|S|If any of these effects last or get worse, tell your doctor or||
1465|075|S|pharmacist promptly.||
1465|076|S|   Remember that this medication has been prescribed because your||
1465|077|S|doctor has judged that the benefit to you is greater than the||
1465|078|S|risk of side effects. Many people using this medication do not||
1465|079|S|have serious side effects.||
1465|080|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
1465|081|S|Contact your doctor promptly if you notice any symptoms of||
1465|082|S|dehydration, such as unusual dry mouth/thirst, fast heartbeat, or||
1465|083|S|dizziness/lightheadedness.||
1465|084|S|   Tell your doctor right away if you have any serious side||
1465|085|S|effects, including: signs of kidney problems (such as change in||
1465|086|S|the amount of urine), severe injection-site reactions (such as||
1465|087|S|blisters, open wound, severe pain/swelling), easy||
1465|088|S|bruising/bleeding.||
1465|089|S|   Get medical help right away if you have any very serious side||
1465|090|S|effects, including: signs of pancreas or gallbladder disease||
1465|091|S|(such as nausea/vomiting that doesn't stop, severe||
1465|092|S|stomach/abdominal pain).||
1465|093|S|   Exenatide does not usually cause low blood sugar||
1465|094|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1465|095|S|prescribed with other diabetes medications, or if you do not get||
1465|096|S|enough calories from food, or if you do unusually heavy exercise.||
1465|097|S|Talk with your doctor or pharmacist about whether the dose of||
1465|098|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1465|099|S|of low blood sugar include sudden sweating, shaking, fast||
1465|100|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1465|101|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1465|102|S|treat low blood sugar. If you don't have these reliable forms of||
1465|103|S|glucose, rapidly raise your blood sugar by eating a quick source||
1465|104|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1465|105|S|juice or non-diet soda. Tell your doctor right away about the||
1465|106|S|reaction and the use of this product. To help prevent low blood||
1465|107|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1465|108|S|Check with your doctor or pharmacist to find out what you should||
1465|109|S|do if you miss a meal.||
1465|110|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1465|111|S|thirst/urination. If these symptoms occur, tell your doctor right||
1465|112|S|away. Your doctor may need to adjust your diabetes medication,||
1465|113|S|exercise program, or diet.||
1465|114|S|   A very serious allergic reaction to this drug is rare.||
1465|115|S|However, get medical help right away if you notice any symptoms||
1465|116|S|of a serious allergic reaction, including: rash, itching/swelling||
1465|117|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1465|118|S|breathing.||
1465|119|S|   This is not a complete list of possible side effects. If you||
1465|120|S|notice other effects not listed above, contact your doctor or||
1465|121|S|pharmacist.||
1465|122|S|   In the US -||
1465|123|S|   Call your doctor for medical advice about side effects. You||
1465|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1465|125|S|www.fda.gov/medwatch.||
1465|126|S|   In Canada - Call your doctor for medical advice about side||
1465|127|S|effects. You may report side effects to Health Canada at||
1465|128|S|1-866-234-2345.||
1465|129|B|||
1465|130|P|PRECAUTIONS:  See also Warning section.||
1465|131|P|   Before using exenatide, tell your doctor or pharmacist if you||
1465|132|P|are allergic to it; or if you have any other allergies. This||
1465|133|P|product may contain inactive ingredients, which can cause||
1465|134|P|allergic reactions or other problems. Talk to your pharmacist for||
1465|135|P|more details.||
1465|136|P|   Before using this medication, tell your doctor or pharmacist||
1465|137|P|your medical history, especially of: a disease of the pancreas||
1465|138|P|(pancreatitis), kidney disease, stomach/intestinal disorders||
1465|139|P|(such as gastroparesis, digestion problems), gallbladder disease,||
1465|140|P|a certain blood disorder from exenatide (drug-induced||
1465|141|P|thrombocytopenia).||
1465|142|P|   You may experience blurred vision, dizziness, or drowsiness||
1465|143|P|due to extremely low or high blood sugar. Do not drive, use||
1465|144|P|machinery, or do anything that needs alertness or clear vision||
1465|145|P|until you can do it safely.||
1465|146|P|   Limit alcohol while using this medication because it can||
1465|147|P|increase your risk of developing low blood sugar.||
1465|148|P|   It may be harder to control your blood sugar when your body is||
1465|149|P|stressed (such as due to fever, infection, injury, or surgery).||
1465|150|P|Consult your doctor because this may require a change in your||
1465|151|P|treatment plan, medications, or blood sugar testing.||
1465|152|P|   Before having surgery, tell your doctor or dentist about all||
1465|153|P|the products you use (including prescription drugs,||
1465|154|P|nonprescription drugs, and herbal products).||
1465|155|P|   During pregnancy, this medication should be used only when||
1465|156|P|clearly needed. Discuss the risks and benefits with your doctor.||
1465|157|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1465|158|P|your doctor for managing your blood sugar while pregnant. Your||
1465|159|P|doctor may change your diabetes treatment during your pregnancy||
1465|160|P|(such as diet and medications including insulin).||
1465|161|P|   It is unknown if this medication passes into breast milk.||
1465|162|P|Consult your doctor before breastfeeding.||
1465|163|B|||
1465|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1465|165|I|medications work or increase your risk for serious side effects.||
1465|166|I|This document does not contain all possible drug interactions.||
1465|167|I|Keep a list of all the products you use (including||
1465|168|I|prescription/nonprescription drugs and herbal products) and share||
1465|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
1465|170|I|the dosage of any medicines without your doctor's approval.||
1465|171|I|   A product that may interact with this drug is: warfarin.||
1465|172|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1465|173|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1465|174|I|heartbeat you would usually feel when your blood sugar falls too||
1465|175|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1465|176|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1465|177|I|   Many drugs can affect your blood sugar, making it harder to||
1465|178|I|control. Before you start, stop, or change any medication, talk||
1465|179|I|with your doctor or pharmacist about how the medication may||
1465|180|I|affect your blood sugar. Check your blood sugar regularly as||
1465|181|I|directed and share the results with your doctor. Tell your doctor||
1465|182|I|right away if you have symptoms of high or low blood sugar. (See||
1465|183|I|also Side Effects section.) Your doctor may need to adjust your||
1465|184|I|diabetes medication, exercise program, or diet.||
1465|185|B|||
1465|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1465|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1465|188|O|poison control center right away. US residents can call||
1465|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1465|190|O|Symptoms of overdose may include: severe nausea/vomiting.||
1465|191|B|||
1465|192|N|NOTES:  Do not share this medication with others.||
1465|193|N|   Attend a diabetes education program to learn more about how to||
1465|194|N|manage your diabetes with medications, diet, exercise, and||
1465|195|N|regular medical exams.||
1465|196|N|   Learn the symptoms of high and low blood sugar and how to||
1465|197|N|treat low blood sugar. Check your blood sugar regularly as||
1465|198|N|directed and share the results with your doctor.||
1465|199|N|   Lab and/or medical tests (such as kidney function, fasting||
1465|200|N|blood glucose, hemoglobin A1c) should be done while you are||
1465|201|N|taking this medication. Keep all medical and lab appointments.||
1465|202|N|Consult your doctor for more details.||
1465|203|B|||
1465|204|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1465|205|D|If it is within 2 days of the next dose, skip the missed dose.||
1465|206|D|Use your next dose at the regular time. Do not double the dose to||
1465|207|D|catch up.||
1465|208|B|||
1465|209|R|STORAGE:  Store the product flat in the refrigerator. Do not||
1465|210|R|freeze. Keep the medication in the original carton to protect||
1465|211|R|from light. This medication may also be stored at room||
1465|212|R|temperature if needed. If the medication is stored at room||
1465|213|R|temperature, discard after 4 weeks. Keep all medications away||
1465|214|R|from children and pets.||
1465|215|R|   Do not flush medications down the toilet or pour them into a||
1465|216|R|drain unless instructed to do so. Properly discard this product||
1465|217|R|when it is expired or no longer needed. Consult your pharmacist||
1465|218|R|or local waste disposal company.||
1465|219|B|||
1465|220|M|MEDICAL ALERT:  Your condition can cause complications in a||
1465|221|M|medical emergency. For information about enrolling in MedicAlert,||
1465|222|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1465|223|B|||
1465|224|A|Information last revised November 2025.||
1465|225|A|Copyright(c) 2025 First Databank, Inc.||
1465|226|B|||
1466|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1466|002|Z|does NOT have all possible information about this product. This||
1466|003|Z|information does not assure that this product is safe, effective,||
1466|004|Z|or appropriate for you. This information is not individual||
1466|005|Z|medical advice and does not substitute for the advice of your||
1466|006|Z|health care professional. Always ask your health care||
1466|007|Z|professional for complete information about this product and your||
1466|008|Z|specific health needs.||
1466|009|B|||
1466|010|T|NON-OPIOID ANTITUSSIVE/DECONGESTANT/EXPECTORANT - ORAL||
1466|011|B|||
1466|012|U|USES:  This combination product is used for the temporary||
1466|013|U|treatment of cough, stuffy nose, and sinus pain/pressure caused||
1466|014|U|by infection (such as the common cold, flu) or other breathing||
1466|015|U|illnesses (such as hay fever, bronchitis). Decongestants (such as||
1466|016|U|pseudoephedrine, phenylephrine) work by narrowing the blood||
1466|017|U|vessels to help relieve stuffy nose symptoms and sinus pressure.||
1466|018|U|Expectorants (such as guaifenesin) work by thinning and loosening||
1466|019|U|mucus in the airways, clearing congestion, and making breathing||
1466|020|U|easier. Non-opioid cough suppressants (such as dextromethorphan,||
1466|021|U|chlophedianol) affect a certain part of the brain (cough center)||
1466|022|U|to help you stop coughing.||
1466|023|U|   Cough-and-cold products have not been shown to be safe or||
1466|024|U|effective in children younger than 6 years. Do not use this||
1466|025|U|product to treat cold symptoms in children younger than 6 years||
1466|026|U|unless specifically directed by the doctor. Some products (such||
1466|027|U|as long-acting tablets/capsules) are not recommended for use in||
1466|028|U|children younger than 12 years. Ask your doctor or pharmacist for||
1466|029|U|more details about using your product safely.||
1466|030|U|   These products do not cure or shorten the length of the common||
1466|031|U|cold and may cause serious side effects. To decrease the risk for||
1466|032|U|serious side effects, carefully follow all dosage directions. Do||
1466|033|U|not use this product to make a child sleepy. Do not give other||
1466|034|U|cough-and-cold medication that might contain the same or similar||
1466|035|U|ingredients (see also Drug Interactions section). Ask the doctor||
1466|036|U|or pharmacist about other ways to relieve cough and cold symptoms||
1466|037|U|(such as drinking enough fluids, using a humidifier or saline||
1466|038|U|nose drops/spray).||
1466|039|B|||
1466|040|H|HOW TO USE:  If you are taking the over-the-counter product to||
1466|041|H|self-treat, read all directions on the product package before||
1466|042|H|taking this medication. If you have any questions, consult your||
1466|043|H|pharmacist. If your doctor has prescribed this medication, take||
1466|044|H|it as directed.||
1466|045|H|   If you are using the liquid form of this medication, carefully||
1466|046|H|measure the dose using a special measuring device/spoon. Do not||
1466|047|H|use a household spoon because you may not get the correct dose.||
1466|048|H|   The dosage is based on your age, medical condition, and||
1466|049|H|response to treatment. Do not increase your dose or take this||
1466|050|H|drug more often than directed. Do not take more of this||
1466|051|H|medication than recommended for your age. There are many brands||
1466|052|H|and forms of this product available. Read the dosing instructions||
1466|053|H|carefully for each product because the amount of cough||
1466|054|H|suppressant and expectorant may be different between products.||
1466|055|H|   Tell your doctor if your symptoms do not get better after 7||
1466|056|H|days or if they get worse or return, or if you have a headache||
1466|057|H|that doesn't go away, fever, or rash. If you think you may have a||
1466|058|H|serious medical problem, get medical help right away.||
1466|059|B|||
1466|060|S|SIDE EFFECTS:  Nausea, vomiting, trouble sleeping, dizziness,||
1466|061|S|headache, or nervousness may occur. If any of these effects last||
1466|062|S|or get worse, tell your doctor or pharmacist promptly.||
1466|063|S|   If your doctor has directed you to use this medication,||
1466|064|S|remember that your doctor has judged that the benefit to you is||
1466|065|S|greater than the risk of side effects. Many people using this||
1466|066|S|medication do not have serious side effects.||
1466|067|S|   This medication may raise your blood pressure. Check your||
1466|068|S|blood pressure regularly and tell your doctor if the results are||
1466|069|S|high.||
1466|070|S|   Stop taking this medication and tell your doctor right away if||
1466|071|S|you have any serious side effects, including:||
1466|072|S|fast/irregular/pounding heartbeat, mental/mood changes (such as||
1466|073|S|confusion, hallucinations, nervousness), seizures, shaking||
1466|074|S|(tremors), trouble urinating.||
1466|075|S|   A very serious allergic reaction to this drug is rare.||
1466|076|S|However, get medical help right away if you notice any symptoms||
1466|077|S|of a serious allergic reaction, including: rash, itching/swelling||
1466|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1466|079|S|breathing.||
1466|080|S|   This is not a complete list of possible side effects. If you||
1466|081|S|notice other effects not listed above, contact your doctor or||
1466|082|S|pharmacist.||
1466|083|S|   In the US -||
1466|084|S|   Call your doctor for medical advice about side effects. You||
1466|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1466|086|S|www.fda.gov/medwatch.||
1466|087|S|   In Canada - Call your doctor for medical advice about side||
1466|088|S|effects. You may report side effects to Health Canada at||
1466|089|S|1-866-234-2345.||
1466|090|B|||
1466|091|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1466|092|P|pharmacist if you are allergic to it; or if you have any other||
1466|093|P|allergies. This product may contain inactive ingredients, which||
1466|094|P|can cause allergic reactions or other problems. Talk to your||
1466|095|P|pharmacist for more details.||
1466|096|P|   If you have any of the following health problems, consult your||
1466|097|P|doctor or pharmacist before using this product: cough with a lot||
1466|098|P|of mucus, chronic cough (such as with asthma, emphysema,||
1466|099|P|smoking), diabetes, a certain eye condition (glaucoma), heart||
1466|100|P|problems (such as heart attack, chest pain, heart failure),||
1466|101|P|fast/irregular heartbeat, high blood pressure, kidney problems,||
1466|102|P|liver disease, overactive thyroid (hyperthyroidism), difficulty||
1466|103|P|urinating (such as due to enlarged prostate).||
1466|104|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1466|105|P|can make you more dizzy. Do not drive, use machinery, or do||
1466|106|P|anything that needs alertness until you can do it safely. Limit||
1466|107|P|alcoholic beverages. Talk to your doctor if you are using||
1466|108|P|marijuana (cannabis).||
1466|109|P|   This medicine may contain sugar, alcohol, or aspartame.||
1466|110|P|Caution is advised if you have diabetes, alcohol dependence,||
1466|111|P|liver disease, phenylketonuria (PKU), or any other condition that||
1466|112|P|requires you to limit/avoid these substances in your diet. Ask||
1466|113|P|your doctor or pharmacist about using this product safely.||
1466|114|P|   Before having surgery, tell your doctor or dentist about all||
1466|115|P|the products you use (including prescription drugs,||
1466|116|P|nonprescription drugs, and herbal products).||
1466|117|P|   Older adults may be more sensitive to the side effects of this||
1466|118|P|medication, especially fast/irregular heartbeat, dizziness,||
1466|119|P|problems urinating, trouble sleeping, or confusion.||
1466|120|P|   Children may be more sensitive to the side effects of this||
1466|121|P|medication, especially agitation.||
1466|122|P|   During pregnancy, this medication should be used only when||
1466|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
1466|124|P|   This medication may pass into breast milk. Consult your doctor||
1466|125|P|before breastfeeding.||
1466|126|B|||
1466|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1466|128|I|medications work or increase your risk for serious side effects.||
1466|129|I|This document does not contain all possible drug interactions.||
1466|130|I|Keep a list of all the products you use (including||
1466|131|I|prescription/nonprescription drugs and herbal products) and share||
1466|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
1466|133|I|the dosage of any medicines without your doctor's approval.||
1466|134|I|   Taking MAO inhibitors with this medication may cause a serious||
1466|135|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1466|136|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1466|137|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1466|138|I|selegiline, tranylcypromine) during treatment with this||
1466|139|I|medication. Most MAO inhibitors should also not be taken for two||
1466|140|I|weeks before treatment with this medication. Ask your doctor when||
1466|141|I|to start or stop taking this medication.||
1466|142|I|   Check the labels on all your medicines (such as allergy or||
1466|143|I|cough-and-cold products) because they may contain similar||
1466|144|I|ingredients (decongestants such as phenylephrine or cough||
1466|145|I|suppressants). Ask your pharmacist about using those products||
1466|146|I|safely.||
1466|147|B|||
1466|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1466|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1466|150|O|poison control center right away. US residents can call||
1466|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1466|152|O|Symptoms of overdose may include: agitation, confusion,||
1466|153|O|hallucinations, seizures.||
1466|154|B|||
1466|155|N|NOTES:  This medication is for temporary use only. Do not use for||
1466|156|N|more than 7 days without first consulting your doctor.||
1466|157|B|||
1466|158|D|MISSED DOSE:  If you are taking this product on a regular||
1466|159|D|schedule and miss a dose, take it as soon as you remember. If it||
1466|160|D|is near the time of the next dose, skip the missed dose. Take||
1466|161|D|your next dose at the regular time. Do not double the dose to||
1466|162|D|catch up.||
1466|163|B|||
1466|164|R|STORAGE:  Different brands of this medication have different||
1466|165|R|storage needs. Check the product package for instructions on how||
1466|166|R|to store your brand, or ask your pharmacist. Keep all medications||
1466|167|R|away from children and pets.||
1466|168|R|   Do not flush medications down the toilet or pour them into a||
1466|169|R|drain unless instructed to do so. Properly discard this product||
1466|170|R|when it is expired or no longer needed. Consult your pharmacist||
1466|171|R|or local waste disposal company.||
1466|172|B|||
1466|173|A|Information last revised July 2025.||
1466|174|A|Copyright(c) 2025 First Databank, Inc.||
1466|175|B|||
1467|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1467|002|Z|does NOT have all possible information about this product. This||
1467|003|Z|information does not assure that this product is safe, effective,||
1467|004|Z|or appropriate for you. This information is not individual||
1467|005|Z|medical advice and does not substitute for the advice of your||
1467|006|Z|health care professional. Always ask your health care||
1467|007|Z|professional for complete information about this product and your||
1467|008|Z|specific health needs.||
1467|009|B|||
1467|010|T|ARTESUNATE - INJECTION||
1467|011|F|(ar-TES-u-nate)||
1467|012|B|||
1467|013|U|USES:  This medication is used to treat malaria. Malaria is an||
1467|014|U|infection caused by mosquito bites received while traveling or||
1467|015|U|living in regions of the world where malaria is common. Malaria||
1467|016|U|parasites enter the body, and live in body tissues such as red||
1467|017|U|blood cells or the liver. This medication is used to kill the||
1467|018|U|malaria parasites living inside red blood cells. You will need to||
1467|019|U|take a different medication (such as primaquine) to kill the||
1467|020|U|malaria parasites living in the liver. Both treatments are needed||
1467|021|U|for a complete cure and to avoid the return of infection||
1467|022|U|(relapse).||
1467|023|B|||
1467|024|H|HOW TO USE:  This medication is given by injection into a vein as||
1467|025|H|directed by your doctor. The first 3 doses are usually given 12||
1467|026|H|hours apart. The following doses are usually given once daily||
1467|027|H|until you are able to take an antimalarial drug by mouth. The||
1467|028|H|dosage is based on your medical condition, weight, and response||
1467|029|H|to treatment.||
1467|030|H|   Tell your doctor if your condition does not get better or if||
1467|031|H|it gets worse.||
1467|032|B|||
1467|033|S|SIDE EFFECTS:  Unusual tiredness may occur. If this effect lasts||
1467|034|S|or gets worse, tell your doctor or pharmacist promptly.||
1467|035|S|   Remember that this medication has been prescribed because your||
1467|036|S|doctor has judged that the benefit to you is greater than the||
1467|037|S|risk of side effects. Many people using this medication do not||
1467|038|S|have serious side effects.||
1467|039|S|   Tell your doctor right away if you have any serious side||
1467|040|S|effects, including: easy bruising/bleeding, signs of kidney||
1467|041|S|problems (such as change in amount of urine), dark urine,||
1467|042|S|yellowing eyes/skin.||
1467|043|S|   A very serious allergic reaction to this drug is rare.||
1467|044|S|However, get medical help right away if you notice any symptoms||
1467|045|S|of a serious allergic reaction, including: rash, itching/swelling||
1467|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1467|047|S|breathing.||
1467|048|S|   This is not a complete list of possible side effects. If you||
1467|049|S|notice other effects not listed above, contact your doctor or||
1467|050|S|pharmacist.||
1467|051|S|   In the US -||
1467|052|S|   Call your doctor for medical advice about side effects. You||
1467|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1467|054|S|www.fda.gov/medwatch.||
1467|055|S|   In Canada - Call your doctor for medical advice about side||
1467|056|S|effects. You may report side effects to Health Canada at||
1467|057|S|1-866-234-2345.||
1467|058|B|||
1467|059|P|PRECAUTIONS:  Before using artesunate, tell your doctor or||
1467|060|P|pharmacist if you are allergic to it; or if you have any other||
1467|061|P|allergies. This product may contain inactive ingredients, which||
1467|062|P|can cause allergic reactions or other problems. Talk to your||
1467|063|P|pharmacist for more details.||
1467|064|P|   Before using this medication, tell your doctor or pharmacist||
1467|065|P|your medical history.||
1467|066|P|   Before having surgery, tell your doctor or dentist about all||
1467|067|P|the products you use (including prescription drugs,||
1467|068|P|nonprescription drugs, and herbal products).||
1467|069|P|   During pregnancy, this medication should be used only when||
1467|070|P|clearly needed. Discuss the risks and benefits with your doctor.||
1467|071|P|   This medication passes into breast milk in small amounts but||
1467|072|P|is unlikely to harm a nursing infant. Consult your doctor before||
1467|073|P|breastfeeding.||
1467|074|B|||
1467|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1467|076|I|medications work or increase your risk for serious side effects.||
1467|077|I|This document does not contain all possible drug interactions.||
1467|078|I|Keep a list of all the products you use (including||
1467|079|I|prescription/nonprescription drugs and herbal products) and share||
1467|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
1467|081|I|the dosage of any medicines without your doctor's approval.||
1467|082|B|||
1467|083|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1467|084|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1467|085|O|poison control center right away. US residents can call||
1467|086|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1467|087|B|||
1467|088|N|NOTES:  Lab and/or medical tests (such as complete blood count)||
1467|089|N|should be done while you are using this medication and for 4||
1467|090|N|weeks after your last dose. Keep all medical and lab||
1467|091|N|appointments.||
1467|092|B|||
1467|093|D|MISSED DOSE:  It is important to get each dose of this medication||
1467|094|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1467|095|D|right away for a new dosing schedule.||
1467|096|B|||
1467|097|R|STORAGE:  Not applicable. This medication is given in a hospital||
1467|098|R|or clinic and will not be stored at home.||
1467|099|B|||
1467|100|A|Information last revised May 2024.||
1467|101|A|Copyright(c) 2025 First Databank, Inc.||
1467|102|B|||
1468|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1468|002|Z|does NOT have all possible information about this product. This||
1468|003|Z|information does not assure that this product is safe, effective,||
1468|004|Z|or appropriate for you. This information is not individual||
1468|005|Z|medical advice and does not substitute for the advice of your||
1468|006|Z|health care professional. Always ask your health care||
1468|007|Z|professional for complete information about this product and your||
1468|008|Z|specific health needs.||
1468|009|B|||
1468|010|T|TAFLUPROST SOLUTION - OPHTHALMIC||
1468|011|F|(TA-floo-prost)||
1468|012|B|||
1468|013|C|COMMON BRAND NAME(S): Zioptan||
1468|014|B|||
1468|015|U|USES:  Tafluprost is used to treat high pressure inside the eye||
1468|016|U|due to glaucoma (open-angle type) or other eye diseases (such as||
1468|017|U|ocular hypertension). Lowering high pressure inside the eye can||
1468|018|U|help prevent blindness. This medication works by regulating the||
1468|019|U|flow of fluid within the eye to maintain a normal pressure.||
1468|020|B|||
1468|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1468|022|H|from your pharmacist before you start using tafluprost and each||
1468|023|H|time you get a refill. If you have any questions, ask your doctor||
1468|024|H|or pharmacist.||
1468|025|H|   Use this medication in the affected eye(s) as directed by your||
1468|026|H|doctor, usually once daily in the evening. Do not use this||
1468|027|H|medication more often than prescribed; using more can make it||
1468|028|H|work less well.||
1468|029|H|   To apply eye drops, wash your hands first. To avoid||
1468|030|H|contamination, do not touch the dropper tip or let it touch your||
1468|031|H|eye or any other surface.||
1468|032|H|   Tilt your head back, look upward, and pull down the lower||
1468|033|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1468|034|H|and place one drop into the pouch. Look downward, gently close||
1468|035|H|your eyes, and place one finger at the corner of your eye (near||
1468|036|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
1468|037|H|opening your eyes. This will prevent the medication from draining||
1468|038|H|out. Try not to blink or rub your eye. Repeat these steps for||
1468|039|H|your other eye if so directed.||
1468|040|H|   If you are using another kind of eye medication (such as drops||
1468|041|H|or ointments), wait at least 5 minutes before applying other||
1468|042|H|medications. Use eye drops before eye ointments to allow the||
1468|043|H|drops to enter the eye.||
1468|044|H|   Wait several minutes for your vision to clear before driving||
1468|045|H|or operating machinery.||
1468|046|H|   Use this medication regularly to get the most benefit from it.||
1468|047|H|Remember to use it at the same time each day. Keep using||
1468|048|H|tafluprost even if you feel well. Most people with glaucoma or||
1468|049|H|high pressure in the eye do not have symptoms.||
1468|050|B|||
1468|051|S|SIDE EFFECTS:  Burning/stinging/irritation/redness of the eye,||
1468|052|S|feeling as if something is in your eye, dry eyes, watering eyes,||
1468|053|S|and increased sensitivity to light may occur. If any of these||
1468|054|S|effects last or get worse, tell your doctor or pharmacist||
1468|055|S|promptly.||
1468|056|S|   This medication may slowly (over months to years) cause the||
1468|057|S|colored portion of the eye (iris) to turn brown. If you are using||
1468|058|S|tafluprost in only one eye, only that iris may change color. An||
1468|059|S|increase in eyelash number/length/thickness and darkening of the||
1468|060|S|eyelashes/eyelids may also occur in the treated eye. These||
1468|061|S|changes may be permanent, but the long-term effects are||
1468|062|S|uncertain. Tell your doctor if this occurs and schedule regular||
1468|063|S|eye exams to monitor it.||
1468|064|S|   Remember that this medication has been prescribed because your||
1468|065|S|doctor has judged that the benefit to you is greater than the||
1468|066|S|risk of side effects. Many people using this medication do not||
1468|067|S|have serious side effects.||
1468|068|S|   Tell your doctor right away if you have any serious side||
1468|069|S|effects, including: vision changes, eye pain/swelling,||
1468|070|S|swelling/redness of the eyelids.||
1468|071|S|   Get medical help right away if you have any very serious side||
1468|072|S|effects, including: rapid vision changes (such as loss of||
1468|073|S|vision).||
1468|074|S|   A very serious allergic reaction to this drug is rare.||
1468|075|S|However, get medical help right away if you notice any symptoms||
1468|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1468|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1468|078|S|breathing.||
1468|079|S|   This is not a complete list of possible side effects. If you||
1468|080|S|notice other effects not listed above, contact your doctor or||
1468|081|S|pharmacist.||
1468|082|S|   In the US -||
1468|083|S|   Call your doctor for medical advice about side effects. You||
1468|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1468|085|S|www.fda.gov/medwatch.||
1468|086|S|   In Canada - Call your doctor for medical advice about side||
1468|087|S|effects. You may report side effects to Health Canada at||
1468|088|S|1-866-234-2345.||
1468|089|B|||
1468|090|P|PRECAUTIONS:  Before taking tafluprost, tell your doctor or||
1468|091|P|pharmacist if you are allergic to it; or if you have any other||
1468|092|P|allergies. This product may contain inactive ingredients, which||
1468|093|P|can cause allergic reactions or other problems. Talk to your||
1468|094|P|pharmacist for more details.||
1468|095|P|   Before using this medication, tell your doctor or pharmacist||
1468|096|P|your medical history, especially of: other eye problems (such as||
1468|097|P|macular edema, iritis, uveitis, lens extraction/aphakia).||
1468|098|P|   After you apply this drug, your vision may become temporarily||
1468|099|P|blurred. Do not drive, use machinery, or do anything that needs||
1468|100|P|clear vision until you can do it safely.||
1468|101|P|   Before having surgery, tell your doctor or dentist about all||
1468|102|P|the products you use (including prescription drugs,||
1468|103|P|nonprescription drugs, and herbal products).||
1468|104|P|   During pregnancy, this medication should be used only when||
1468|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
1468|106|P|   It is unknown if this drug passes into breast milk. Consult||
1468|107|P|your doctor before breastfeeding.||
1468|108|B|||
1468|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1468|110|I|medications work or increase your risk for serious side effects.||
1468|111|I|This document does not contain all possible drug interactions.||
1468|112|I|Keep a list of all the products you use (including||
1468|113|I|prescription/nonprescription drugs and herbal products) and share||
1468|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
1468|115|I|the dosage of any medicines without your doctor's approval.||
1468|116|I|   Some products that may interact with this drug include:||
1468|117|I|eyelash treatments (such as topically applied bimatoprost).||
1468|118|B|||
1468|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1468|120|O|has overdosed and has serious symptoms such as passing out or||
1468|121|O|trouble breathing, call 911. Otherwise, call a poison control||
1468|122|O|center right away. US residents can call 1-800-222-1222. Canada||
1468|123|O|residents can call 1-844-764-7669.||
1468|124|B|||
1468|125|N|NOTES:  Do not share this medication with others.||
1468|126|N|   Lab and/or medical tests (such as eye exams) should be done||
1468|127|N|while you are using this medication. Keep all medical and lab||
1468|128|N|appointments. Consult your doctor for more details.||
1468|129|B|||
1468|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
1468|131|D|if it is on the same day. If you do not remember until the next||
1468|132|D|day, skip the missed dose. Use your next dose at the regular||
1468|133|D|time. Do not double the dose to catch up.||
1468|134|B|||
1468|135|R|STORAGE:  This medication comes as single-use containers in a||
1468|136|R|pouch. Store the unopened pouches in the refrigerator. After||
1468|137|R|opening the pouch, store unused containers in the pouch at room||
1468|138|R|temperature away from moisture. Do not store in the bathroom.||
1468|139|R|Once the pouch is opened, this medication expires after 30 days.||
1468|140|R|Keep all medications away from children and pets.||
1468|141|R|   Do not flush medications down the toilet or pour them into a||
1468|142|R|drain unless instructed to do so. Properly discard this product||
1468|143|R|when it is expired or no longer needed. Consult your pharmacist||
1468|144|R|or local waste disposal company.||
1468|145|B|||
1468|146|A|Information last revised September 2024.||
1468|147|A|Copyright(c) 2025 First Databank, Inc.||
1468|148|B|||
1469|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1469|002|Z|does NOT have all possible information about this product. This||
1469|003|Z|information does not assure that this product is safe, effective,||
1469|004|Z|or appropriate for you. This information is not individual||
1469|005|Z|medical advice and does not substitute for the advice of your||
1469|006|Z|health care professional. Always ask your health care||
1469|007|Z|professional for complete information about this product and your||
1469|008|Z|specific health needs.||
1469|009|B|||
1469|010|T|NITROGLYCERIN OINTMENT - RECTAL||
1469|011|F|(NYE-troe-GLIS-er-in)||
1469|012|B|||
1469|013|C|COMMON BRAND NAME(S): Rectiv||
1469|014|B|||
1469|015|U|USES:  Nitroglycerin ointment is used to treat moderate to severe||
1469|016|U|pain caused by long-term tears in the lining of the anus (anal||
1469|017|U|fissures). This medication works by relaxing the muscles around||
1469|018|U|the blood vessels which reduces pressure inside the anus and||
1469|019|U|relieves pain. Nitroglycerin belongs to a class of drugs known as||
1469|020|U|nitrates.||
1469|021|B|||
1469|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1469|023|H|from your pharmacist before you start using nitroglycerin and||
1469|024|H|each time you get a refill. If you have any questions, ask your||
1469|025|H|doctor or pharmacist.||
1469|026|H|   Cover your finger with plastic wrap, a disposable medical||
1469|027|H|glove, or a finger cot. Using the measuring guide that comes with||
1469|028|H|your product, squeeze out the prescribed amount of ointment onto||
1469|029|H|your finger. Gently insert your finger inside the anus, up to the||
1469|030|H|first finger joint. Spread the ointment around the inside of the||
1469|031|H|anus. If you cannot do this because it is too painful, you may||
1469|032|H|apply the ointment to the outside of the anus.||
1469|033|H|   Throw away the finger covering and wash your hands after each||
1469|034|H|dose. Apply this medication as directed by your doctor, usually||
1469|035|H|every 12 hours for up to 3 weeks. Do not apply this medication in||
1469|036|H|the eyes, mouth, or vagina.||
1469|037|H|   Use this medication regularly to get the most benefit from it.||
1469|038|H|To help you remember, use it at the same times each day.||
1469|039|H|   Tell your doctor if your pain does not get better.||
1469|040|B|||
1469|041|S|SIDE EFFECTS:  Headache may occur, but usually lasts a short time||
1469|042|S|after each dose. With continued use of this medication, some||
1469|043|S|people may not be bothered as much by the headaches. Your doctor||
1469|044|S|may recommend treating headaches with a nonprescription pain||
1469|045|S|reliever (such as acetaminophen).||
1469|046|S|   Nitroglycerin can also cause a drop in your blood pressure,||
1469|047|S|which can lead to dizziness and lightheadedness. To reduce the||
1469|048|S|risk of dizziness and lightheadedness, get up slowly when rising||
1469|049|S|from a sitting or lying position.||
1469|050|S|   If any of these effects last or get worse, tell your doctor or||
1469|051|S|pharmacist promptly.||
1469|052|S|   Remember that this medication has been prescribed because your||
1469|053|S|doctor has judged that the benefit to you is greater than the||
1469|054|S|risk of side effects. Many people using this medication do not||
1469|055|S|have serious side effects.||
1469|056|S|   A very serious allergic reaction to this drug is rare.||
1469|057|S|However, get medical help right away if you notice any symptoms||
1469|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1469|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1469|060|S|breathing.||
1469|061|S|   This is not a complete list of possible side effects. If you||
1469|062|S|notice other effects not listed above, contact your doctor or||
1469|063|S|pharmacist.||
1469|064|S|   In the US -||
1469|065|S|   Call your doctor for medical advice about side effects. You||
1469|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1469|067|S|www.fda.gov/medwatch.||
1469|068|S|   In Canada - Call your doctor for medical advice about side||
1469|069|S|effects. You may report side effects to Health Canada at||
1469|070|S|1-866-234-2345.||
1469|071|B|||
1469|072|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1469|073|P|pharmacist if you are allergic to nitroglycerin; or to nitrates,||
1469|074|P|nitrites, or isosorbide; or if you have any other allergies. This||
1469|075|P|product may contain inactive ingredients, which can cause||
1469|076|P|allergic reactions or other problems. Talk to your pharmacist for||
1469|077|P|more details.||
1469|078|P|   Before using this medication, tell your doctor or pharmacist||
1469|079|P|your medical history, especially of: anemia, low blood pressure,||
1469|080|P|dehydration, increased pressure inside your head (such as due to||
1469|081|P|head/brain injury), heart/blood vessel problems (such as heart||
1469|082|P|failure, recent heart attack).||
1469|083|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1469|084|P|can make you more dizzy. Do not drive, use machinery, or do||
1469|085|P|anything that needs alertness until you can do it safely. Limit||
1469|086|P|alcoholic beverages because they can also cause a drop in your||
1469|087|P|blood pressure. Talk to your doctor if you are using marijuana||
1469|088|P|(cannabis).||
1469|089|P|   Before having surgery, tell your doctor or dentist about all||
1469|090|P|the products you use (including prescription drugs,||
1469|091|P|nonprescription drugs, and herbal products).||
1469|092|P|   Older adults may be more sensitive to the side effects of this||
1469|093|P|medication, especially dizziness and lightheadedness.||
1469|094|P|   During pregnancy, this medication should be used only when||
1469|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1469|096|P|   It is unknown if this medication passes into breast milk.||
1469|097|P|Consult your doctor before breastfeeding.||
1469|098|B|||
1469|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1469|100|I|medications work or increase your risk for serious side effects.||
1469|101|I|This document does not contain all possible drug interactions.||
1469|102|I|Keep a list of all the products you use (including||
1469|103|I|prescription/nonprescription drugs and herbal products) and share||
1469|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1469|105|I|the dosage of any medicines without your doctor's approval.||
1469|106|I|   Some products that may interact with this drug include: drugs||
1469|107|I|to treat erectile dysfunction-ED or pulmonary hypertension (such||
1469|108|I|as sildenafil, tadalafil), riociguat, vericiguat.||
1469|109|B|||
1469|110|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1469|111|O|has overdosed and has serious symptoms such as passing out or||
1469|112|O|trouble breathing, call 911. Otherwise, call a poison control||
1469|113|O|center right away. US residents can call 1-800-222-1222. Canada||
1469|114|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1469|115|O|include: pale/gray/blue colored skin/lips/nails, severe headache,||
1469|116|O|fainting, shortness of breath, fast heartbeat, confusion, unusual||
1469|117|O|tiredness.||
1469|118|B|||
1469|119|N|NOTES:  Do not share this medication with others.||
1469|120|B|||
1469|121|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
1469|122|D|remember. If it is near the time of the next dose, skip the||
1469|123|D|missed dose. Use your next dose at the regular time. Do not||
1469|124|D|double the dose to catch up.||
1469|125|B|||
1469|126|R|STORAGE:  Store at room temperature. Once the tube is opened,||
1469|127|R|this medication expires after 8 weeks. Keep all medications away||
1469|128|R|from children and pets.||
1469|129|R|   Do not flush medications down the toilet or pour them into a||
1469|130|R|drain unless instructed to do so. Properly discard this product||
1469|131|R|when it is expired or no longer needed. Consult your pharmacist||
1469|132|R|or local waste disposal company.||
1469|133|B|||
1469|134|A|Information last revised November 2024.||
1469|135|A|Copyright(c) 2025 First Databank, Inc.||
1469|136|B|||
1470|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1470|002|Z|does NOT have all possible information about this product. This||
1470|003|Z|information does not assure that this product is safe, effective,||
1470|004|Z|or appropriate for you. This information is not individual||
1470|005|Z|medical advice and does not substitute for the advice of your||
1470|006|Z|health care professional. Always ask your health care||
1470|007|Z|professional for complete information about this product and your||
1470|008|Z|specific health needs.||
1470|009|B|||
1470|010|T|ANTHRALIN SHAMPOO - TOPICAL||
1470|011|F|(AN-thra-lin)||
1470|012|B|||
1470|013|C|COMMON BRAND NAME(S): Zithranol||
1470|014|B|||
1470|015|U|USES:  This medication is used for the treatment of scalp||
1470|016|U|psoriasis. Anthralin is a man-made version of a natural substance||
1470|017|U|found in goa powder, which is from the araroba tree. It works by||
1470|018|U|decreasing inflammation and slowing down the growth of skin||
1470|019|U|cells.||
1470|020|B|||
1470|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1470|022|H|from your pharmacist before you start using anthralin shampoo and||
1470|023|H|each time you get a refill. If you have any questions, ask your||
1470|024|H|doctor or pharmacist.||
1470|025|H|   This medication is for use on the scalp as directed by your||
1470|026|H|doctor, usually 3 to 4 times a week. Wet hair, then massage||
1470|027|H|anthralin shampoo onto scalp. Work into a gentle lather and leave||
1470|028|H|on the scalp for 3 to 5 minutes. Rinse thoroughly with lukewarm||
1470|029|H|water. Avoid contact with eyes. Although no additional shampoo is||
1470|030|H|necessary to cleanse the hair, a non-medicated shampoo or||
1470|031|H|conditioner can be applied after using anthralin shampoo, if||
1470|032|H|desired.||
1470|033|H|   Use this product regularly to get the most benefit from it.||
1470|034|H|Tell your doctor if your condition does not get better or if it||
1470|035|H|gets worse.||
1470|036|B|||
1470|037|S|SIDE EFFECTS:  Temporary redness or irritation of the treated||
1470|038|S|scalp may occur. If either of these effects lasts or gets worse,||
1470|039|S|tell your doctor or pharmacist promptly.||
1470|040|S|   Temporary staining of hair or skin may occur. To lessen the||
1470|041|S|chance of staining, apply carefully only on the scalp, avoiding||
1470|042|S|your face. Try to avoid getting anthralin shampoo on fabrics||
1470|043|S|since permanent staining may occur.||
1470|044|S|   Remember that this medication has been prescribed because your||
1470|045|S|doctor has judged that the benefit to you is greater than the||
1470|046|S|risk of side effects. Many people using this medication do not||
1470|047|S|have serious side effects.||
1470|048|S|   A very serious allergic reaction to this drug is rare.||
1470|049|S|However, get medical help right away if you notice any symptoms||
1470|050|S|of a serious allergic reaction, including: rash, itching/swelling||
1470|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1470|052|S|breathing.||
1470|053|S|   This is not a complete list of possible side effects. If you||
1470|054|S|notice other effects not listed above, contact your doctor or||
1470|055|S|pharmacist.||
1470|056|S|   In the US -||
1470|057|S|   Call your doctor for medical advice about side effects. You||
1470|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1470|059|S|www.fda.gov/medwatch.||
1470|060|S|   In Canada - Call your doctor for medical advice about side||
1470|061|S|effects. You may report side effects to Health Canada at||
1470|062|S|1-866-234-2345.||
1470|063|B|||
1470|064|P|PRECAUTIONS:  Before using anthralin, tell your doctor or||
1470|065|P|pharmacist if you are allergic to it; or if you have any other||
1470|066|P|allergies. This product may contain inactive ingredients, which||
1470|067|P|can cause allergic reactions or other problems. Talk to your||
1470|068|P|pharmacist for more details.||
1470|069|P|   Before using this medication, tell your doctor or pharmacist||
1470|070|P|your medical history.||
1470|071|P|   Before having surgery, tell your doctor or dentist about all||
1470|072|P|the products you use (including prescription drugs,||
1470|073|P|nonprescription drugs, and herbal products).||
1470|074|P|   During pregnancy, this medication should be used only when||
1470|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
1470|076|P|   It is unknown if this drug passes into breast milk. However,||
1470|077|P|it is unlikely to pass into breast milk or harm a nursing infant.||
1470|078|P|Consult your doctor before breastfeeding.||
1470|079|B|||
1470|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1470|081|I|medications work or increase your risk for serious side effects.||
1470|082|I|This document does not contain all possible drug interactions.||
1470|083|I|Keep a list of all the products you use (including||
1470|084|I|prescription/nonprescription drugs and herbal products) and share||
1470|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
1470|086|I|the dosage of any medicines without your doctor's approval.||
1470|087|B|||
1470|088|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1470|089|O|has overdosed and has serious symptoms such as passing out or||
1470|090|O|trouble breathing, call 911. Otherwise, call a poison control||
1470|091|O|center right away. US residents can call 1-800-222-1222. Canada||
1470|092|O|residents can call 1-844-764-7669.||
1470|093|B|||
1470|094|N|NOTES:  Do not share this product with others.||
1470|095|B|||
1470|096|D|MISSED DOSE:  Not applicable.||
1470|097|B|||
1470|098|R|STORAGE:  Store at room temperature away from light. Keep all||
1470|099|R|medications away from children and pets.||
1470|100|R|   Do not flush medications down the toilet or pour them into a||
1470|101|R|drain unless instructed to do so. Properly discard this product||
1470|102|R|when it is expired or no longer needed. Consult your pharmacist||
1470|103|R|or local waste disposal company.||
1470|104|B|||
1470|105|A|Information last revised November 2024.||
1470|106|A|Copyright(c) 2025 First Databank, Inc.||
1470|107|B|||
1471|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1471|002|Z|does NOT have all possible information about this product. This||
1471|003|Z|information does not assure that this product is safe, effective,||
1471|004|Z|or appropriate for you. This information is not individual||
1471|005|Z|medical advice and does not substitute for the advice of your||
1471|006|Z|health care professional. Always ask your health care||
1471|007|Z|professional for complete information about this product and your||
1471|008|Z|specific health needs.||
1471|009|B|||
1471|010|T|PRUCALOPRIDE - ORAL||
1471|011|F|(proo-KAL-oh-pride)||
1471|012|B|||
1471|013|C|COMMON BRAND NAME(S): Motegrity||
1471|014|B|||
1471|015|U|USES:  This medication is used to treat chronic constipation. It||
1471|016|U|is used when other medications used to treat constipation (such||
1471|017|U|as laxatives) have not provided relief. Prucalopride works by||
1471|018|U|improving how well your stomach and intestines move food through||
1471|019|U|the bowels during digestion.||
1471|020|B|||
1471|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1471|022|H|from your pharmacist before you start taking prucalopride and||
1471|023|H|each time you get a refill. If you have any questions, ask your||
1471|024|H|doctor or pharmacist.||
1471|025|H|   Take this medication by mouth with or without food as directed||
1471|026|H|by your doctor, usually once a day. The dosage is based on your||
1471|027|H|age, medical condition, and response to treatment.||
1471|028|H|   Use this medication regularly to get the most benefit from it.||
1471|029|H|To help you remember, take it at the same time each day.||
1471|030|H|   Tell your doctor if you do not get relief of constipation||
1471|031|H|after 3 to 4 days. Your doctor may recommend you temporarily take||
1471|032|H|additional medication (such as a stimulant laxative) along with||
1471|033|H|prucalopride for fast relief of constipation. If additional||
1471|034|H|medication is recommended, carefully follow your doctor's||
1471|035|H|directions for use. Ask your doctor how long you should keep||
1471|036|H|taking this and/or other medications for constipation.||
1471|037|B|||
1471|038|S|SIDE EFFECTS:  Nausea, abdominal pain, diarrhea, or headache||
1471|039|S|commonly occur during the first 1 to 2 days of treatment.||
1471|040|S|Dizziness or tiredness may also occur. If any of these effects||
1471|041|S|last or get worse, tell your doctor or pharmacist promptly.||
1471|042|S|   Remember that this medication has been prescribed because your||
1471|043|S|doctor has judged that the benefit to you is greater than the||
1471|044|S|risk of side effects. Many people using this medication do not||
1471|045|S|have serious side effects.||
1471|046|S|   Tell your doctor right away if you have any serious side||
1471|047|S|effects, including: fast/irregular heartbeat.||
1471|048|S|   Stop taking prucalopride and get medical help right away if||
1471|049|S|you have any very serious side effects, including: abdominal pain||
1471|050|S|that is severe or doesn't go away, bloody diarrhea, rectal||
1471|051|S|bleeding, mental/mood changes (such as depression, thoughts of||
1471|052|S|suicide or of hurting yourself).||
1471|053|S|   A very serious allergic reaction to this drug is rare.||
1471|054|S|However, get medical help right away if you notice any symptoms||
1471|055|S|of a serious allergic reaction, including: rash, itching/swelling||
1471|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1471|057|S|breathing.||
1471|058|S|   This is not a complete list of possible side effects. If you||
1471|059|S|notice other effects not listed above, contact your doctor or||
1471|060|S|pharmacist.||
1471|061|S|   In the US -||
1471|062|S|   Call your doctor for medical advice about side effects. You||
1471|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1471|064|S|www.fda.gov/medwatch.||
1471|065|S|   In Canada - Call your doctor for medical advice about side||
1471|066|S|effects. You may report side effects to Health Canada at||
1471|067|S|1-866-234-2345.||
1471|068|B|||
1471|069|P|PRECAUTIONS:  Before taking prucalopride, tell your doctor or||
1471|070|P|pharmacist if you are allergic to it; or if you have any other||
1471|071|P|allergies. This product may contain inactive ingredients (such as||
1471|072|P|lactose), which can cause allergic reactions or other problems.||
1471|073|P|Talk to your pharmacist for more details.||
1471|074|P|   Before using this medication, tell your doctor or pharmacist||
1471|075|P|your medical history, especially of: diabetes, heart problems||
1471|076|P|(such as irregular heartbeat, previous heart attack), kidney||
1471|077|P|problems, liver disease, mental/mood problems, other||
1471|078|P|stomach/abdominal disorders (such as intestinal||
1471|079|P|perforation/obstruction, ileus, Crohn's disease, ulcerative||
1471|080|P|colitis).||
1471|081|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1471|082|P|can make you more dizzy. Do not drive, use machinery, or do||
1471|083|P|anything that needs alertness until you can do it safely. Limit||
1471|084|P|alcoholic beverages. Talk to your doctor if you are using||
1471|085|P|marijuana (cannabis).||
1471|086|P|   Before having surgery, tell your doctor or dentist about all||
1471|087|P|the products you use (including prescription drugs,||
1471|088|P|nonprescription drugs, and herbal products).||
1471|089|P|   During pregnancy, this medication should be used only when||
1471|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
1471|091|P|   This medication passes into breast milk. Consult your doctor||
1471|092|P|before breastfeeding.||
1471|093|B|||
1471|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1471|095|I|medications work or increase your risk for serious side effects.||
1471|096|I|This document does not contain all possible drug interactions.||
1471|097|I|Keep a list of all the products you use (including||
1471|098|I|prescription/nonprescription drugs and herbal products) and share||
1471|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
1471|100|I|the dosage of any medicines without your doctor's approval.||
1471|101|I|   A product that may interact with this drug is: pramlintide.||
1471|102|B|||
1471|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1471|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1471|105|O|poison control center right away. US residents can call||
1471|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1471|107|B|||
1471|108|N|NOTES:  Do not share this medication with others.||
1471|109|B|||
1471|110|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1471|111|D|remember. If it is near the time of the next dose, skip the||
1471|112|D|missed dose. Take your next dose at the regular time. Do not||
1471|113|D|double the dose to catch up.||
1471|114|B|||
1471|115|R|STORAGE:  Store in the original container at room temperature||
1471|116|R|away from light and moisture. Do not store in the bathroom. Keep||
1471|117|R|all medications away from children and pets.||
1471|118|R|   Do not flush medications down the toilet or pour them into a||
1471|119|R|drain unless instructed to do so. Properly discard this product||
1471|120|R|when it is expired or no longer needed. Consult your pharmacist||
1471|121|R|or local waste disposal company.||
1471|122|B|||
1471|123|A|Information last revised July 2025.||
1471|124|A|Copyright(c) 2025 First Databank, Inc.||
1471|125|B|||
1473|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1473|002|Z|does NOT have all possible information about this product. This||
1473|003|Z|information does not assure that this product is safe, effective,||
1473|004|Z|or appropriate for you. This information is not individual||
1473|005|Z|medical advice and does not substitute for the advice of your||
1473|006|Z|health care professional. Always ask your health care||
1473|007|Z|professional for complete information about this product and your||
1473|008|Z|specific health needs.||
1473|009|B|||
1473|010|T|SITAGLIPTIN/METFORMIN EXTENDED-RELEASE - ORAL||
1473|011|F|(SIT-a-GLIP-tin/met-FOR-min)||
1473|012|B|||
1473|013|C|COMMON BRAND NAME(S): Janumet XR, Zituvimet XR||
1473|014|B|||
1473|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1473|016|W|cause a serious (sometimes fatal) condition called lactic||
1473|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1473|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1473|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1473|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1473|021|W|you are using certain drugs. For some conditions, your doctor may||
1473|022|W|tell you to stop taking this medication for a short time. Ask||
1473|023|W|your doctor or pharmacist for more details.||
1473|024|W|   Stop taking this medication and get medical help right away if||
1473|025|W|you have any symptoms of lactic acidosis, such as unusual||
1473|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1473|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1473|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1473|029|B|||
1473|030|U|USES:  Sitagliptin/metformin is used with a proper diet and||
1473|031|U|exercise program to control high blood sugar in people with type||
1473|032|U|2 diabetes. Controlling high blood sugar helps prevent kidney||
1473|033|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1473|034|U|function problems. Proper control of diabetes may also lessen||
1473|035|U|your risk of a heart attack or stroke.||
1473|036|U|   This product contains 2 medications: sitagliptin and||
1473|037|U|metformin. Sitagliptin works by increasing levels of natural||
1473|038|U|substances called incretins. Incretins help to control blood||
1473|039|U|sugar by increasing insulin release, especially after a meal.||
1473|040|U|They also decrease the amount of sugar your liver makes.||
1473|041|U|Metformin works by helping to restore your body's proper response||
1473|042|U|to the insulin you naturally produce. It also decreases the||
1473|043|U|amount of sugar that your liver makes and that your||
1473|044|U|stomach/intestines absorb.||
1473|045|B|||
1473|046|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1473|047|H|Patient Information Leaflet provided by your pharmacist before||
1473|048|H|you start using sitagliptin/metformin and each time you get a||
1473|049|H|refill. If you have any questions, ask your doctor or pharmacist.||
1473|050|H|   Take this medication by mouth as directed by your doctor,||
1473|051|H|usually once daily with a meal, preferably in the evening.||
1473|052|H|Swallow the tablets whole. Do not crush or chew the tablets.||
1473|053|H|Doing so can release all of the drug at once, increasing the risk||
1473|054|H|of side effects. Drink plenty of fluids while taking this||
1473|055|H|medication unless otherwise directed by your doctor.||
1473|056|H|   The dosage is based on your medical condition, response to||
1473|057|H|treatment, and other medications you may be taking. Be sure to||
1473|058|H|tell your doctor and pharmacist about all the products you use||
1473|059|H|(including prescription drugs, nonprescription drugs, and herbal||
1473|060|H|products). To reduce your risk of side effects (such as upset||
1473|061|H|stomach), your doctor may direct you to start this medication at||
1473|062|H|a low dose and gradually increase your dose. Follow your doctor's||
1473|063|H|instructions carefully.||
1473|064|H|   Take this medication regularly to get the most benefit from||
1473|065|H|it. To help you remember, take it at the same time each day.||
1473|066|H|Carefully follow the medication treatment plan, meal plan, and||
1473|067|H|exercise program your doctor has recommended.||
1473|068|H|   Tell your doctor if your condition does not get better or if||
1473|069|H|it gets worse (your blood sugar is too high or too low).||
1473|070|B|||
1473|071|S|SIDE EFFECTS:  See also Warning section.||
1473|072|S|   Nausea, vomiting, stomach upset, diarrhea, headache, or a||
1473|073|S|metallic taste in the mouth may occur. A tablet may also appear||
1473|074|S|in your stool. If any of these effects last or get worse, tell||
1473|075|S|your doctor or pharmacist promptly. If stomach symptoms return||
1473|076|S|later (after taking the same dose for several days or weeks),||
1473|077|S|tell your doctor right away. Stomach symptoms that occur after||
1473|078|S|the first days of your treatment may be signs of lactic acidosis.||
1473|079|S|   Remember that this medication has been prescribed because your||
1473|080|S|doctor has judged that the benefit to you is greater than the||
1473|081|S|risk of side effects. Many people using this medication do not||
1473|082|S|have serious side effects.||
1473|083|S|   Tell your doctor right away if you have any serious side||
1473|084|S|effects, including: joint pain, signs of kidney problems (such as||
1473|085|S|change in the amount of urine), unusual skin blisters, signs of||
1473|086|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1473|087|S|unusual tiredness, unusual/sudden weight gain).||
1473|088|S|   Get medical help right away if you have any very serious side||
1473|089|S|effects, including: signs of disease of the pancreas (such as||
1473|090|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain||
1473|091|S|which may spread to the back).||
1473|092|S|   This medication does not usually cause low blood sugar||
1473|093|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1473|094|S|prescribed with other diabetes medications, or if you do not get||
1473|095|S|enough calories from food, or if you do unusually heavy exercise.||
1473|096|S|Talk with your doctor or pharmacist about whether the dose of||
1473|097|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1473|098|S|of low blood sugar include sudden sweating, shaking, fast||
1473|099|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1473|100|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1473|101|S|treat low blood sugar. If you don't have these reliable forms of||
1473|102|S|glucose, rapidly raise your blood sugar by eating a quick source||
1473|103|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1473|104|S|juice or non-diet soda. Tell your doctor right away about the||
1473|105|S|reaction and the use of this product. To help prevent low blood||
1473|106|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1473|107|S|Check with your doctor or pharmacist to find out what you should||
1473|108|S|do if you miss a meal.||
1473|109|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1473|110|S|thirst/urination. If these symptoms occur, tell your doctor right||
1473|111|S|away. Your doctor may need to adjust your diabetes medication,||
1473|112|S|exercise program, or diet.||
1473|113|S|   A very serious allergic reaction to this drug is rare.||
1473|114|S|However, get medical help right away if you notice any symptoms||
1473|115|S|of a serious allergic reaction, including: rash, itching/swelling||
1473|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1473|117|S|breathing.||
1473|118|S|   This is not a complete list of possible side effects. If you||
1473|119|S|notice other effects not listed above, contact your doctor or||
1473|120|S|pharmacist.||
1473|121|S|   In the US -||
1473|122|S|   Call your doctor for medical advice about side effects. You||
1473|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1473|124|S|www.fda.gov/medwatch.||
1473|125|S|   In Canada - Call your doctor for medical advice about side||
1473|126|S|effects. You may report side effects to Health Canada at||
1473|127|S|1-866-234-2345.||
1473|128|B|||
1473|129|P|PRECAUTIONS:  See also Warning section.||
1473|130|P|   Before taking this medication, tell your doctor or pharmacist||
1473|131|P|if you are allergic to sitagliptin or metformin; or if you have||
1473|132|P|any other allergies. This product may contain inactive||
1473|133|P|ingredients, which can cause allergic reactions or other||
1473|134|P|problems. Talk to your pharmacist for more details.||
1473|135|P|   Before using this medication, tell your doctor or pharmacist||
1473|136|P|your medical history, especially of: kidney disease, severe||
1473|137|P|breathing problems (such as obstructive lung disease, severe||
1473|138|P|asthma), liver disease, a disease of the pancreas (pancreatitis),||
1473|139|P|stones in your gallbladder (gallstones), blood problems (such as||
1473|140|P|anemia, vitamin B12 deficiency).||
1473|141|P|   Before having surgery or any X-ray/scanning procedure using||
1473|142|P|iodinated contrast, tell your doctor or dentist about all the||
1473|143|P|products you use (including prescription drugs, nonprescription||
1473|144|P|drugs, and herbal products). You may need to stop this medication||
1473|145|P|for a short time for the surgery/procedure. Ask your doctor or||
1473|146|P|dentist for instructions before your surgery/procedure.||
1473|147|P|   You may experience blurred vision, dizziness, or drowsiness||
1473|148|P|due to extremely low or high blood sugar. Do not drive, use||
1473|149|P|machinery, or do anything that needs alertness or clear vision||
1473|150|P|until you can do it safely.||
1473|151|P|   Limit alcohol while taking this medication because it can||
1473|152|P|increase your risk of developing lactic acidosis, pancreatitis,||
1473|153|P|and low blood sugar.||
1473|154|P|   High fever, "water pills" (diuretics such as||
1473|155|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1473|156|P|may cause dehydration and increase your risk of lactic acidosis.||
1473|157|P|Stop taking this medication and tell your doctor right away if||
1473|158|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1473|159|P|fluids to prevent dehydration unless your doctor directs you||
1473|160|P|otherwise.||
1473|161|P|   It may be harder to control your blood sugar when your body is||
1473|162|P|stressed (such as due to fever, infection, injury, or surgery).||
1473|163|P|Consult your doctor because this may require a change in your||
1473|164|P|treatment plan, medications, or blood sugar testing.||
1473|165|P|   Older adults may be more sensitive to the side effects of this||
1473|166|P|drug, especially low blood sugar or lactic acidosis.||
1473|167|P|   Metformin can cause changes in the menstrual cycle (promote||
1473|168|P|ovulation) and increase the risk of becoming pregnant. Consult||
1473|169|P|your doctor or pharmacist about the use of reliable birth control||
1473|170|P|while using this medication.||
1473|171|P|   During pregnancy, this medication should be used only when||
1473|172|P|clearly needed. Discuss the risks and benefits with your doctor.||
1473|173|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1473|174|P|your doctor for managing your blood sugar while pregnant. Your||
1473|175|P|doctor may change your diabetes treatment during your pregnancy||
1473|176|P|(such as diet and medications including insulin).||
1473|177|P|   Metformin passes into breast milk. It is unknown if||
1473|178|P|sitagliptin passes into breast milk. Consult your doctor before||
1473|179|P|breastfeeding.||
1473|180|B|||
1473|181|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1473|182|I|medications work or increase your risk for serious side effects.||
1473|183|I|This document does not contain all possible drug interactions.||
1473|184|I|Keep a list of all the products you use (including||
1473|185|I|prescription/nonprescription drugs and herbal products) and share||
1473|186|I|it with your doctor and pharmacist. Do not start, stop, or change||
1473|187|I|the dosage of any medicines without your doctor's approval.||
1473|188|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1473|189|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1473|190|I|heartbeat you would usually feel when your blood sugar falls too||
1473|191|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1473|192|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1473|193|I|   Many drugs can affect your blood sugar, making it harder to||
1473|194|I|control. Before you start, stop, or change any medication, talk||
1473|195|I|with your doctor or pharmacist about how the medication may||
1473|196|I|affect your blood sugar. Check your blood sugar regularly as||
1473|197|I|directed and share the results with your doctor. Tell your doctor||
1473|198|I|right away if you have symptoms of high or low blood sugar. (See||
1473|199|I|also Side Effects section.) Your doctor may need to adjust your||
1473|200|I|diabetes medication, exercise program, or diet.||
1473|201|B|||
1473|202|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1473|203|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1473|204|O|poison control center right away. US residents can call||
1473|205|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1473|206|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
1473|207|O|include: shakiness, sweating, loss of consciousness, severe||
1473|208|O|drowsiness, severe nausea/vomiting/diarrhea, rapid breathing,||
1473|209|O|slow/irregular heartbeat.||
1473|210|B|||
1473|211|N|NOTES:  Do not share this medication with others.||
1473|212|N|   Attend a diabetes education program to learn more about how to||
1473|213|N|manage your diabetes with medications, diet, exercise, and||
1473|214|N|regular medical exams.||
1473|215|N|   Learn the symptoms of high and low blood sugar and how to||
1473|216|N|treat low blood sugar. Check your blood sugar regularly as||
1473|217|N|directed.||
1473|218|N|   Lab and/or medical tests (such as kidney function, liver||
1473|219|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
1473|220|N|should be done before you start taking this medication and while||
1473|221|N|you are taking it. Keep all medical and lab appointments. Consult||
1473|222|N|your doctor for more details.||
1473|223|B|||
1473|224|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1473|225|D|remember. If it is near the time of the next dose, skip the||
1473|226|D|missed dose. Take your next dose at the regular time. Do not||
1473|227|D|double the dose to catch up.||
1473|228|B|||
1473|229|R|STORAGE:  Store at room temperature away from light and moisture.||
1473|230|R|Do not store in the bathroom. Some brands of this medication||
1473|231|R|should be stored in their original container and used within 1||
1473|232|R|month of opening the bottle. Check the product package or ask||
1473|233|R|your pharmacist about your specific brand. Keep all medications||
1473|234|R|away from children and pets.||
1473|235|R|   Do not flush medications down the toilet or pour them into a||
1473|236|R|drain unless instructed to do so. Properly discard this product||
1473|237|R|when it is expired or no longer needed. Consult your pharmacist||
1473|238|R|or local waste disposal company.||
1473|239|B|||
1473|240|M|MEDICAL ALERT:  Your condition can cause complications in a||
1473|241|M|medical emergency. For information about enrolling in MedicAlert,||
1473|242|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1473|243|B|||
1473|244|A|Information last revised May 2025.||
1473|245|A|Copyright(c) 2025 First Databank, Inc.||
1473|246|B|||
1474|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1474|002|Z|does NOT have all possible information about this product. This||
1474|003|Z|information does not assure that this product is safe, effective,||
1474|004|Z|or appropriate for you. This information is not individual||
1474|005|Z|medical advice and does not substitute for the advice of your||
1474|006|Z|health care professional. Always ask your health care||
1474|007|Z|professional for complete information about this product and your||
1474|008|Z|specific health needs.||
1474|009|B|||
1474|010|T|LINAGLIPTIN/METFORMIN - ORAL||
1474|011|F|(LIN-a-GLIP-tin/met-FOR-min)||
1474|012|B|||
1474|013|C|COMMON BRAND NAME(S): Jentadueto||
1474|014|B|||
1474|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1474|016|W|cause a serious (sometimes fatal) condition called lactic||
1474|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1474|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1474|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1474|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1474|021|W|you are using certain drugs. For some conditions, your doctor may||
1474|022|W|tell you to stop taking this medication for a short time. Ask||
1474|023|W|your doctor or pharmacist for more details.||
1474|024|W|   Stop taking this medication and get medical help right away if||
1474|025|W|you have any symptoms of lactic acidosis, such as unusual||
1474|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1474|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1474|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1474|029|B|||
1474|030|U|USES:  Linagliptin/metformin is used with a proper diet and||
1474|031|U|exercise program to control high blood sugar in people with type||
1474|032|U|2 diabetes. Controlling high blood sugar helps prevent kidney||
1474|033|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1474|034|U|function problems. Proper control of diabetes may also lessen||
1474|035|U|your risk of a heart attack or stroke.||
1474|036|U|   This product contains 2 medications: linagliptin and||
1474|037|U|metformin. Linagliptin works by increasing levels of natural||
1474|038|U|substances called incretins. Incretins help to control blood||
1474|039|U|sugar by increasing insulin release, especially after a meal.||
1474|040|U|They also decrease the amount of sugar your liver makes.||
1474|041|U|Metformin works by helping to restore your body's proper response||
1474|042|U|to the insulin you naturally produce. It also decreases the||
1474|043|U|amount of sugar that your liver makes and that your||
1474|044|U|stomach/intestines absorb.||
1474|045|B|||
1474|046|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1474|047|H|Patient Information Leaflet provided by your pharmacist before||
1474|048|H|you start taking linagliptin/metformin and each time you get a||
1474|049|H|refill. If you have any questions, ask your doctor or pharmacist.||
1474|050|H|   Take this medication by mouth as directed by your doctor,||
1474|051|H|usually twice daily with meals. Drink plenty of fluids while||
1474|052|H|taking this medication unless otherwise directed by your doctor.||
1474|053|H|   The dosage is based on your medical condition, response to||
1474|054|H|treatment, and other medications you may be taking. Be sure to||
1474|055|H|tell your doctor and pharmacist about all the products you use||
1474|056|H|(including prescription drugs, nonprescription drugs, and herbal||
1474|057|H|products). To reduce your risk of side effects (such as upset||
1474|058|H|stomach), your doctor may direct you to start this medication at||
1474|059|H|a low dose and gradually increase your dose. Follow your doctor's||
1474|060|H|instructions carefully.||
1474|061|H|   Take this medication regularly to get the most benefit from||
1474|062|H|it. To help you remember, take it at the same times each day.||
1474|063|H|Carefully follow the medication treatment plan, meal plan, and||
1474|064|H|exercise program your doctor has recommended.||
1474|065|H|   Tell your doctor if your condition does not get better or if||
1474|066|H|it gets worse (your blood sugar is too high or too low).||
1474|067|B|||
1474|068|S|SIDE EFFECTS:  See also Warning section.||
1474|069|S|   Nausea, vomiting, stomach upset, diarrhea, or a metallic taste||
1474|070|S|in the mouth may occur. If any of these effects last or get||
1474|071|S|worse, tell your doctor or pharmacist promptly. If stomach||
1474|072|S|symptoms return later (after taking the same dose for several||
1474|073|S|days or weeks), tell your doctor right away. Stomach symptoms||
1474|074|S|that occur after the first days of your treatment may be signs of||
1474|075|S|lactic acidosis.||
1474|076|S|   Remember that this medication has been prescribed because your||
1474|077|S|doctor has judged that the benefit to you is greater than the||
1474|078|S|risk of side effects. Many people using this medication do not||
1474|079|S|have serious side effects.||
1474|080|S|   Tell your doctor right away if you have any serious side||
1474|081|S|effects, including: joint pain, unusual skin blisters, signs of||
1474|082|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1474|083|S|unusual tiredness, unusual/sudden weight gain).||
1474|084|S|   Get medical help right away if you have any very serious side||
1474|085|S|effects, including: signs of disease of the pancreas (such as||
1474|086|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain||
1474|087|S|which may spread to the back).||
1474|088|S|   This medication does not usually cause low blood sugar||
1474|089|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1474|090|S|prescribed with other diabetes medications, or if you do not get||
1474|091|S|enough calories from food, or if you do unusually heavy exercise.||
1474|092|S|Talk with your doctor or pharmacist about whether the dose of||
1474|093|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1474|094|S|of low blood sugar include sudden sweating, shaking, fast||
1474|095|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1474|096|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1474|097|S|treat low blood sugar. If you don't have these reliable forms of||
1474|098|S|glucose, rapidly raise your blood sugar by eating a quick source||
1474|099|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1474|100|S|juice or non-diet soda. Tell your doctor right away about the||
1474|101|S|reaction and the use of this product. To help prevent low blood||
1474|102|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1474|103|S|Check with your doctor or pharmacist to find out what you should||
1474|104|S|do if you miss a meal.||
1474|105|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1474|106|S|thirst/urination. If these symptoms occur, tell your doctor right||
1474|107|S|away. Your doctor may need to adjust your diabetes medication,||
1474|108|S|exercise program, or diet.||
1474|109|S|   A very serious allergic reaction to this drug is rare.||
1474|110|S|However, get medical help right away if you notice any symptoms||
1474|111|S|of a serious allergic reaction, including: rash, itching/swelling||
1474|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1474|113|S|breathing.||
1474|114|S|   This is not a complete list of possible side effects. If you||
1474|115|S|notice other effects not listed above, contact your doctor or||
1474|116|S|pharmacist.||
1474|117|S|   In the US -||
1474|118|S|   Call your doctor for medical advice about side effects. You||
1474|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1474|120|S|www.fda.gov/medwatch.||
1474|121|S|   In Canada - Call your doctor for medical advice about side||
1474|122|S|effects. You may report side effects to Health Canada at||
1474|123|S|1-866-234-2345.||
1474|124|B|||
1474|125|P|PRECAUTIONS:  See also Warning section.||
1474|126|P|   Before taking this medication, tell your doctor or pharmacist||
1474|127|P|if you are allergic to linagliptin or metformin; or if you have||
1474|128|P|any other allergies. This product may contain inactive||
1474|129|P|ingredients, which can cause allergic reactions or other||
1474|130|P|problems. Talk to your pharmacist for more details.||
1474|131|P|   Before using this medication, tell your doctor or pharmacist||
1474|132|P|your medical history, especially of: kidney disease, severe||
1474|133|P|breathing problems (such as obstructive lung disease, severe||
1474|134|P|asthma), liver disease, a disease of the pancreas (pancreatitis),||
1474|135|P|stones in your gallbladder (gallstones), blood problems (such as||
1474|136|P|anemia, vitamin B12 deficiency).||
1474|137|P|   Before having surgery or any X-ray/scanning procedure using||
1474|138|P|iodinated contrast, tell your doctor or dentist about all the||
1474|139|P|products you use (including prescription drugs, nonprescription||
1474|140|P|drugs, and herbal products). You may need to stop this medication||
1474|141|P|for a short time for the surgery/procedure. Ask your doctor or||
1474|142|P|dentist for instructions before your surgery/procedure.||
1474|143|P|   You may experience blurred vision, dizziness, or drowsiness||
1474|144|P|due to extremely low or high blood sugar. Do not drive, use||
1474|145|P|machinery, or do anything that needs alertness or clear vision||
1474|146|P|until you can do it safely.||
1474|147|P|   Limit alcohol while taking this medication because it can||
1474|148|P|increase your risk of developing lactic acidosis, pancreatitis,||
1474|149|P|and low blood sugar.||
1474|150|P|   High fever, "water pills" (diuretics such as||
1474|151|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1474|152|P|may cause dehydration and increase your risk of lactic acidosis.||
1474|153|P|Stop taking this medication and tell your doctor right away if||
1474|154|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1474|155|P|fluids to prevent dehydration unless your doctor directs you||
1474|156|P|otherwise.||
1474|157|P|   It may be harder to control your blood sugar when your body is||
1474|158|P|stressed (such as due to fever, infection, injury, or surgery).||
1474|159|P|Consult your doctor because this may require a change in your||
1474|160|P|treatment plan, medications, or blood sugar testing.||
1474|161|P|   Older adults may be more sensitive to the side effects of this||
1474|162|P|drug, especially low blood sugar or lactic acidosis.||
1474|163|P|   Metformin can cause changes in the menstrual cycle (promote||
1474|164|P|ovulation) and increase the risk of becoming pregnant. Consult||
1474|165|P|your doctor or pharmacist about the use of reliable birth control||
1474|166|P|while using this medication.||
1474|167|P|   During pregnancy, this medication should be used only when||
1474|168|P|clearly needed. Discuss the risks and benefits with your doctor.||
1474|169|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1474|170|P|your doctor for managing your blood sugar while pregnant. Your||
1474|171|P|doctor may change your diabetes treatment during your pregnancy||
1474|172|P|(such as diet and medications including insulin).||
1474|173|P|   Metformin passes into breast milk. It is unknown if||
1474|174|P|linagliptin passes into breast milk. Consult your doctor before||
1474|175|P|breastfeeding.||
1474|176|B|||
1474|177|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1474|178|I|medications work or increase your risk for serious side effects.||
1474|179|I|This document does not contain all possible drug interactions.||
1474|180|I|Keep a list of all the products you use (including||
1474|181|I|prescription/nonprescription drugs and herbal products) and share||
1474|182|I|it with your doctor and pharmacist. Do not start, stop, or change||
1474|183|I|the dosage of any medicines without your doctor's approval.||
1474|184|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1474|185|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1474|186|I|heartbeat you would usually feel when your blood sugar falls too||
1474|187|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1474|188|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1474|189|I|   Many drugs can affect your blood sugar, making it harder to||
1474|190|I|control. Before you start, stop, or change any medication, talk||
1474|191|I|with your doctor or pharmacist about how the medication may||
1474|192|I|affect your blood sugar. Check your blood sugar regularly as||
1474|193|I|directed and share the results with your doctor. Tell your doctor||
1474|194|I|right away if you have symptoms of high or low blood sugar. (See||
1474|195|I|also Side Effects section.) Your doctor may need to adjust your||
1474|196|I|diabetes medication, exercise program, or diet.||
1474|197|I|   Other medications can affect the removal of linagliptin from||
1474|198|I|your body, which may affect how linagliptin works. One example is||
1474|199|I|rifampin, among others.||
1474|200|B|||
1474|201|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1474|202|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1474|203|O|poison control center right away. US residents can call||
1474|204|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1474|205|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
1474|206|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
1474|207|O|rapid breathing, slow/irregular heartbeat.||
1474|208|B|||
1474|209|N|NOTES:  Do not share this medication with others.||
1474|210|N|   Attend a diabetes education program to learn more about how to||
1474|211|N|manage your diabetes with medications, diet, exercise, and||
1474|212|N|regular medical exams.||
1474|213|N|   Learn the symptoms of high and low blood sugar and how to||
1474|214|N|treat low blood sugar. Check your blood sugar regularly as||
1474|215|N|directed.||
1474|216|N|   Lab and/or medical tests (such as kidney function, liver||
1474|217|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
1474|218|N|should be done before you start taking this medication and while||
1474|219|N|you are taking it. Keep all medical and lab appointments. Consult||
1474|220|N|your doctor for more details.||
1474|221|B|||
1474|222|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1474|223|D|remember. If it is near the time of the next dose, skip the||
1474|224|D|missed dose. Take your next dose at the regular time. Do not||
1474|225|D|double the dose to catch up.||
1474|226|B|||
1474|227|R|STORAGE:  Store at room temperature away from light and moisture.||
1474|228|R|Do not store in the bathroom. Keep all medications away from||
1474|229|R|children and pets.||
1474|230|R|   Do not flush medications down the toilet or pour them into a||
1474|231|R|drain unless instructed to do so. Properly discard this product||
1474|232|R|when it is expired or no longer needed. Consult your pharmacist||
1474|233|R|or local waste disposal company.||
1474|234|B|||
1474|235|M|MEDICAL ALERT:  Your condition can cause complications in a||
1474|236|M|medical emergency. For information about enrolling in MedicAlert,||
1474|237|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1474|238|B|||
1474|239|A|Information last revised May 2025.||
1474|240|A|Copyright(c) 2025 First Databank, Inc.||
1474|241|B|||
1476|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1476|002|Z|does NOT have all possible information about this product. This||
1476|003|Z|information does not assure that this product is safe, effective,||
1476|004|Z|or appropriate for you. This information is not individual||
1476|005|Z|medical advice and does not substitute for the advice of your||
1476|006|Z|health care professional. Always ask your health care||
1476|007|Z|professional for complete information about this product and your||
1476|008|Z|specific health needs.||
1476|009|B|||
1476|010|T|DIMETHICONE SPRAY - TOPICAL||
1476|011|F|(dye-METH-i-kone)||
1476|012|B|||
1476|013|U|USES:  This medication is used to treat head lice, tiny insects||
1476|014|U|that infest and irritate your scalp. Head lice lay small white||
1476|015|U|eggs (nits) at the roots of hair close to the scalp, especially||
1476|016|U|on the hairline at the back of the neck and behind the ears.||
1476|017|U|Dimethicone works by stopping the lice and their eggs from||
1476|018|U|getting air, killing them by suffocation.||
1476|019|B|||
1476|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1476|021|H|from your pharmacist before you start using dimethicone and each||
1476|022|H|time you get a refill. If you have any questions, ask your doctor||
1476|023|H|or pharmacist.||
1476|024|H|   People who are in close contact with the infected person, such||
1476|025|H|as members of the same household, should also be checked for lice||
1476|026|H|and nits. Use a comb to help look for head lice or nits. Treat||
1476|027|H|everyone infected with lice on the same day to prevent getting||
1476|028|H|lice again. A regular comb can be used before treatment to remove||
1476|029|H|any tangles. Clean the comb thoroughly after use. See also Notes||
1476|030|H|section.||
1476|031|H|   This medication is for external use only. Use this medication||
1476|032|H|when your hair is dry. Do not wet your hair before applying.||
1476|033|H|Before using for the first time, screw the dispensing pump onto||
1476|034|H|the bottle and prime the spray bottle as directed. Close your||
1476|035|H|eyes tightly during application and avoid getting dimethicone in||
1476|036|H|your eyes, nose, or mouth. If the medication accidentally gets||
1476|037|H|into the eye(s), rinse right away for 10 to 15 minutes with||
1476|038|H|plenty of water. Since you should keep your eyes closed during||
1476|039|H|application, you may need to have another person help you apply||
1476|040|H|this medication. Children will need an adult to apply this||
1476|041|H|medication for them. Spray this medication carefully over all||
1476|042|H|hair on the scalp as directed by the manufacturer. Massage in||
1476|043|H|well until the hair is completely wetted with the solution.||
1476|044|H|   After application, leave the medication on the hair for at||
1476|045|H|least 30 minutes. After dimethicone has been left on for at least||
1476|046|H|30 minutes, you may use a lice comb to carefully comb hair and||
1476|047|H|remove the dead lice and nits. Do not wash out the medication.||
1476|048|H|Leave the hair to dry for at least 8 hours (such as overnight).||
1476|049|H|After waiting a total of at least 8 hours, dimethicone can be||
1476|050|H|washed out with your usual shampoo.||
1476|051|H|   You or anyone who helps you apply this medication should wash||
1476|052|H|hands after application. After 8 to 10 days, the treatment must||
1476|053|H|be repeated. Tell your doctor if head lice remain after the||
1476|054|H|second treatment with dimethicone.||
1476|055|B|||
1476|056|S|SIDE EFFECTS:  Skin or eye irritation/redness may occur. If any||
1476|057|S|of these effects last or get worse, tell your doctor or||
1476|058|S|pharmacist promptly.||
1476|059|S|   If your doctor has directed you to use this medication,||
1476|060|S|remember that your doctor has judged that the benefit to you is||
1476|061|S|greater than the risk of side effects. Many people using this||
1476|062|S|medication do not have serious side effects.||
1476|063|S|   A very serious allergic reaction to this drug is rare.||
1476|064|S|However, get medical help right away if you notice any symptoms||
1476|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1476|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1476|067|S|breathing.||
1476|068|S|   This is not a complete list of possible side effects. If you||
1476|069|S|notice other effects not listed above, contact your doctor or||
1476|070|S|pharmacist.||
1476|071|S|   In the US -||
1476|072|S|   Call your doctor for medical advice about side effects. You||
1476|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1476|074|S|www.fda.gov/medwatch.||
1476|075|S|   In Canada - Call your doctor for medical advice about side||
1476|076|S|effects. You may report side effects to Health Canada at||
1476|077|S|1-866-234-2345.||
1476|078|B|||
1476|079|P|PRECAUTIONS:  Before using dimethicone, tell your doctor or||
1476|080|P|pharmacist if you are allergic to it; or if you have any other||
1476|081|P|allergies. This product may contain inactive ingredients, which||
1476|082|P|can cause allergic reactions or other problems. Talk to your||
1476|083|P|pharmacist for more details.||
1476|084|P|   Before using this medication, tell your doctor or pharmacist||
1476|085|P|your medical history, especially of: skin conditions or||
1476|086|P|sensitivities.||
1476|087|P|   Constant or forceful scratching of the skin/scalp may lead to||
1476|088|P|a bacterial skin infection. Tell your doctor right away if you||
1476|089|P|develop pus or worsening redness.||
1476|090|P|   Before having surgery, tell your doctor or dentist about all||
1476|091|P|the products you use (including prescription drugs,||
1476|092|P|nonprescription drugs, and herbal products).||
1476|093|P|   This product is flammable. Do not use near an open flame or||
1476|094|P|heat source which uses an open flame.||
1476|095|P|   Tell your doctor if you are pregnant before using this||
1476|096|P|medication.||
1476|097|P|   It is unknown if dimethicone passes into breast milk. Consult||
1476|098|P|your doctor before breastfeeding.||
1476|099|B|||
1476|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1476|101|I|medications work or increase your risk for serious side effects.||
1476|102|I|This document does not contain all possible drug interactions.||
1476|103|I|Keep a list of all the products you use (including||
1476|104|I|prescription/nonprescription drugs and herbal products) and share||
1476|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
1476|106|I|the dosage of any medicines without your doctor's approval.||
1476|107|I|   This product may react with certain hair care and hair tinting||
1476|108|I|products.||
1476|109|B|||
1476|110|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1476|111|O|has overdosed and has serious symptoms such as passing out or||
1476|112|O|trouble breathing, call 911. Otherwise, call a poison control||
1476|113|O|center right away. US residents can call 1-800-222-1222. Canada||
1476|114|O|residents can call 1-844-764-7669.||
1476|115|B|||
1476|116|N|NOTES:  To avoid spreading lice to another person or getting lice||
1476|117|N|again, machine-wash all head wear, clothing, bed linens, and||
1476|118|N|towels with hot water, then dry in a dryer at high setting for at||
1476|119|N|least 20 minutes. Items such as pillows or stuffed animals that||
1476|120|N|cannot be washed should be dry cleaned, sealed in a plastic bag||
1476|121|N|for at least 2 weeks, or sprayed with a disinfectant that kills||
1476|122|N|lice. Brushes or combs should be soaked in hot water (hotter than||
1476|123|N|130 degrees F/54 degrees C) for at least 5 to 10 minutes.||
1476|124|N|Furniture and floors should be thoroughly vacuumed.||
1476|125|B|||
1476|126|D|MISSED DOSE:  Not applicable.||
1476|127|B|||
1476|128|R|STORAGE:  Store at room temperature. This medication is||
1476|129|R|flammable. Keep it away from heat and open flame. Keep all||
1476|130|R|medications away from children and pets.||
1476|131|R|   Do not flush medications down the toilet or pour them into a||
1476|132|R|drain unless instructed to do so. Properly discard this product||
1476|133|R|when it is expired or no longer needed. Consult your pharmacist||
1476|134|R|or local waste disposal company.||
1476|135|B|||
1476|136|A|Information last revised July 2025.||
1476|137|A|Copyright(c) 2025 First Databank, Inc.||
1476|138|B|||
1477|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1477|002|Z|does NOT have all possible information about this product. This||
1477|003|Z|information does not assure that this product is safe, effective,||
1477|004|Z|or appropriate for you. This information is not individual||
1477|005|Z|medical advice and does not substitute for the advice of your||
1477|006|Z|health care professional. Always ask your health care||
1477|007|Z|professional for complete information about this product and your||
1477|008|Z|specific health needs.||
1477|009|B|||
1477|010|T|RALTEGRAVIR CHEWABLE - ORAL||
1477|011|F|(ral-TEG-ra-vir)||
1477|012|B|||
1477|013|C|COMMON BRAND NAME(S): Isentress||
1477|014|B|||
1477|015|U|USES:  Raltegravir is used with other HIV medications to help||
1477|016|U|control HIV infection. It helps to decrease the amount of HIV in||
1477|017|U|your body so your immune system can work better. This lowers your||
1477|018|U|chance of getting HIV complications (such as new infections,||
1477|019|U|cancer) and improves your quality of life. Raltegravir is known||
1477|020|U|as an integrase inhibitor. It blocks the virus from growing and||
1477|021|U|infecting more cells.||
1477|022|U|   Raltegravir is not a cure for HIV infection. To decrease your||
1477|023|U|risk of spreading HIV disease to others, continue to take all HIV||
1477|024|U|medications exactly as prescribed by your doctor. Use an||
1477|025|U|effective barrier method (latex or polyurethane condoms/dental||
1477|026|U|dams) during sexual activity as directed by your doctor. Do not||
1477|027|U|share personal items (such as needles/syringes, toothbrushes, and||
1477|028|U|razors) that may have contacted blood or other body fluids.||
1477|029|U|Consult your doctor or pharmacist for more details.||
1477|030|B|||
1477|031|V|OTHER USES:  This section contains uses of this drug that are not||
1477|032|V|listed in the approved professional labeling for the drug but||
1477|033|V|that may be prescribed by your health care professional. Use this||
1477|034|V|drug for a condition that is listed in this section only if it||
1477|035|V|has been so prescribed by your health care professional.||
1477|036|V|   This product may also be used to lessen the risk of HIV||
1477|037|V|infection after contact with the virus (for example, due to a||
1477|038|V|needle stick). Ask your doctor for more details.||
1477|039|B|||
1477|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1477|041|H|from your pharmacist before you start taking raltegravir and each||
1477|042|H|time you get a refill. If you have any questions, ask your doctor||
1477|043|H|or pharmacist.||
1477|044|H|   Take this medication by mouth with or without food as directed||
1477|045|H|by your doctor, usually 2 times daily. This medication may be||
1477|046|H|chewed or swallowed whole. If a child has difficulty chewing the||
1477|047|H|tablet, some forms of this medication may be crushed and mixed||
1477|048|H|with liquid. Talk to your doctor or pharmacist for more details.||
1477|049|H|   The dosage is based on your medical condition, response to||
1477|050|H|treatment, age, weight, and other medications you may be taking.||
1477|051|H|Be sure to tell your doctor and pharmacist about all the products||
1477|052|H|you use (including prescription drugs, nonprescription drugs, and||
1477|053|H|herbal products).||
1477|054|H|   Avoid using antacids that contain aluminum or magnesium while||
1477|055|H|taking this medication. These antacids can make raltegravir work||
1477|056|H|less well.||
1477|057|H|   It is very important to keep taking this medication (and other||
1477|058|H|HIV medications) exactly as prescribed by your doctor. Do not||
1477|059|H|skip any doses.||
1477|060|H|   Do not increase your dose or use this drug more often or for||
1477|061|H|longer than prescribed. Your condition will not improve any||
1477|062|H|faster, and your risk of side effects will increase.||
1477|063|H|   Do not take less of this drug than prescribed or stop taking||
1477|064|H|it (or other HIV medicines) even for a short time unless directed||
1477|065|H|to do so by your doctor. Doing so may cause the amount of virus||
1477|066|H|to increase and/or make the infection more difficult to treat||
1477|067|H|(resistant).||
1477|068|H|   For the best effect, take this medication at evenly spaced||
1477|069|H|times. To help you remember, take this medication at the same||
1477|070|H|times every day.||
1477|071|H|   Do not switch between the film-coated tablet, the chewable||
1477|072|H|tablet, or the powder packet for oral suspension forms of||
1477|073|H|raltegravir without asking your doctor or pharmacist first.||
1477|074|B|||
1477|075|S|SIDE EFFECTS:  Headache, nausea, and trouble sleeping may occur.||
1477|076|S|If any of these effects last or get worse, tell your doctor or||
1477|077|S|pharmacist promptly.||
1477|078|S|   Remember that this medication has been prescribed because your||
1477|079|S|doctor has judged that the benefit to you is greater than the||
1477|080|S|risk of side effects. Many people using this medication do not||
1477|081|S|have serious side effects.||
1477|082|S|   As your immune system gets stronger, it can begin to fight off||
1477|083|S|infections you already had, possibly causing disease symptoms to||
1477|084|S|come back. You could also have symptoms if your immune system||
1477|085|S|becomes overactive. This reaction may happen at any time (soon||
1477|086|S|after starting HIV treatment or many months later). Tell your||
1477|087|S|doctor right away if you have any serious symptoms, including:||
1477|088|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1477|089|S|that doesn't go away, headaches that are severe or don't go away,||
1477|090|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1477|091|S|changes, signs of infection (such as sore throat that doesn't go||
1477|092|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1477|093|S|sores), signs of an overactive thyroid (such as irritability,||
1477|094|S|nervousness, heat intolerance, fast/pounding/irregular||
1477|095|S|heartbeat).||
1477|096|S|   Tell your doctor right away if you have any serious side||
1477|097|S|effects, including: nausea/vomiting that doesn't stop, signs of||
1477|098|S|kidney problems (such as change in the amount of urine), loss of||
1477|099|S|appetite, severe stomach/abdominal pain, dark urine, yellowing||
1477|100|S|eyes/skin.||
1477|101|S|   Changes in body fat may occur while you are taking this||
1477|102|S|medication (such as increased fat in the upper back and stomach||
1477|103|S|areas, decreased fat in the arms and legs). The cause and||
1477|104|S|long-term effects of these changes are unknown. Discuss the risks||
1477|105|S|and benefits of treatment with your doctor, as well as the||
1477|106|S|possible use of exercise to reduce this side effect.||
1477|107|S|   A very serious allergic reaction to this drug is rare.||
1477|108|S|However, get medical help right away if you notice any symptoms||
1477|109|S|of a serious allergic reaction, including: rash (especially if||
1477|110|S|you also have fever, blisters, mouth sores, eye redness/swelling,||
1477|111|S|muscle/joint pain), itching/swelling (especially of the||
1477|112|S|face/tongue/throat), severe dizziness, trouble breathing.||
1477|113|S|   This is not a complete list of possible side effects. If you||
1477|114|S|notice other effects not listed above, contact your doctor or||
1477|115|S|pharmacist.||
1477|116|S|   In the US -||
1477|117|S|   Call your doctor for medical advice about side effects. You||
1477|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1477|119|S|www.fda.gov/medwatch.||
1477|120|S|   In Canada - Call your doctor for medical advice about side||
1477|121|S|effects. You may report side effects to Health Canada at||
1477|122|S|1-866-234-2345.||
1477|123|B|||
1477|124|P|PRECAUTIONS:  Before taking raltegravir, tell your doctor or||
1477|125|P|pharmacist if you are allergic to it; or if you have any other||
1477|126|P|allergies. This product may contain inactive ingredients, which||
1477|127|P|can cause allergic reactions or other problems. Talk to your||
1477|128|P|pharmacist for more details.||
1477|129|P|   Before using this medication, tell your doctor or pharmacist||
1477|130|P|your medical history, especially of: liver disease (such as||
1477|131|P|hepatitis B, hepatitis C), muscle disorders (such as||
1477|132|P|rhabdomyolysis, myopathy), high blood levels of creatine kinase||
1477|133|P|(high CK test results).||
1477|134|P|   Before having surgery, tell your doctor or dentist about all||
1477|135|P|the products you use (including prescription drugs,||
1477|136|P|nonprescription drugs, and herbal products).||
1477|137|P|   This medication may contain aspartame. If you have||
1477|138|P|phenylketonuria (PKU) or any other condition that requires you to||
1477|139|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
1477|140|P|doctor or pharmacist about using this medication safely.||
1477|141|P|   During pregnancy, this medication should be used only when||
1477|142|P|clearly needed. Treatment can lower the risk of passing HIV||
1477|143|P|infection to your baby, and raltegravir may be part of that||
1477|144|P|treatment. Discuss the risks and benefits with your doctor.||
1477|145|P|   This medication passes into breast milk. Because breast milk||
1477|146|P|may transmit HIV, consult your doctor before breastfeeding.||
1477|147|B|||
1477|148|I|DRUG INTERACTIONS:  See also How to Use section.||
1477|149|I|   Drug interactions may change how your medications work or||
1477|150|I|increase your risk for serious side effects. This document does||
1477|151|I|not contain all possible drug interactions. Keep a list of all||
1477|152|I|the products you use (including prescription/nonprescription||
1477|153|I|drugs and herbal products) and share it with your doctor and||
1477|154|I|pharmacist. Do not start, stop, or change the dosage of any||
1477|155|I|medicines without your doctor's approval.||
1477|156|I|   A product that may interact with this drug is: orlistat.||
1477|157|B|||
1477|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1477|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1477|160|O|poison control center right away. US residents can call||
1477|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1477|162|B|||
1477|163|N|NOTES:  Do not share this medication with others.||
1477|164|N|   Lab and/or medical tests (such as viral load, T-cell counts)||
1477|165|N|should be done while you are taking this medication. Keep all||
1477|166|N|medical and lab appointments. Consult your doctor for more||
1477|167|N|details.||
1477|168|B|||
1477|169|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1477|170|D|remember. If it is near the time of the next dose, skip the||
1477|171|D|missed dose. Take your next dose at the regular time. Do not||
1477|172|D|double the dose to catch up.||
1477|173|B|||
1477|174|R|STORAGE:  Store in the original bottle at room temperature away||
1477|175|R|from light and moisture. Do not store in the bathroom. Keep the||
1477|176|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1477|177|R|when not in use. Keep all medications away from children and||
1477|178|R|pets.||
1477|179|R|   Do not flush medications down the toilet or pour them into a||
1477|180|R|drain unless instructed to do so. Properly discard this product||
1477|181|R|when it is expired or no longer needed. Consult your pharmacist||
1477|182|R|or local waste disposal company.||
1477|183|B|||
1477|184|A|Information last revised April 2025.||
1477|185|A|Copyright(c) 2025 First Databank, Inc.||
1477|186|B|||
1479|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1479|002|Z|does NOT have all possible information about this product. This||
1479|003|Z|information does not assure that this product is safe, effective,||
1479|004|Z|or appropriate for you. This information is not individual||
1479|005|Z|medical advice and does not substitute for the advice of your||
1479|006|Z|health care professional. Always ask your health care||
1479|007|Z|professional for complete information about this product and your||
1479|008|Z|specific health needs.||
1479|009|B|||
1479|010|T|OMEPRAZOLE/CLARITHROMYCIN/AMOXICILLIN - ORAL||
1479|011|F|(oh-MEP-ra-zole/kla-RITH-roe-MYE-sin/a-MOX-i-sil-in)||
1479|012|B|||
1479|013|C|COMMON BRAND NAME(S): Omeclamox-Pak||
1479|014|B|||
1479|015|U|USES:  This product is used to treat stomach/intestinal ulcers||
1479|016|U|caused by the bacteria H. pylori and to prevent the ulcers from||
1479|017|U|returning. Treating ulcers reduces the risk of serious damage to||
1479|018|U|the lining of the stomach/intestines (such as bleeding, tearing,||
1479|019|U|blockage).||
1479|020|U|   Omeprazole is known as a proton pump inhibitor (PPI). It works||
1479|021|U|by blocking acid production in the stomach. Decreasing excess||
1479|022|U|stomach acid can help ulcers heal. Amoxicillin and clarithromycin||
1479|023|U|are antibiotics used to treat a wide variety of bacterial||
1479|024|U|infections (including H. pylori). Treating the infection helps||
1479|025|U|reduce the risk of ulcers returning. Amoxicillin is a||
1479|026|U|penicillin-type antibiotic and clarithromycin is a macrolide-type||
1479|027|U|antibiotic. They work by stopping the growth of bacteria.||
1479|028|U|   The antibiotics in this product treat only bacterial||
1479|029|U|infections. Antibiotics do not work for viral infections (such as||
1479|030|U|common cold, flu). Using any antibiotic when it is not needed can||
1479|031|U|cause it to not work for future infections.||
1479|032|B|||
1479|033|H|HOW TO USE:  Each packet contains both the morning and evening||
1479|034|H|doses of this medication (a 1-day supply). Consult your doctor or||
1479|035|H|pharmacist for instructions on the proper use of this product.||
1479|036|H|   Take this medication by mouth as directed by your doctor,||
1479|037|H|usually 1 dose (4 pills) before a meal, twice daily. Swallow the||
1479|038|H|omeprazole capsules whole. Do not crush or chew.||
1479|039|H|   If you have trouble swallowing the omeprazole capsule, you may||
1479|040|H|open the capsule if it is not sealed and carefully sprinkle its||
1479|041|H|contents on a spoonful of soft, cool applesauce. Swallow all of||
1479|042|H|the mixture right away without chewing it. Then drink a glass of||
1479|043|H|cool water to make sure you have swallowed all of the dose. Do||
1479|044|H|not prepare the mixture ahead of time for later use. Doing so may||
1479|045|H|destroy the drug.||
1479|046|H|   For the best effect, take this product at evenly spaced times.||
1479|047|H|To help you remember, take this product at the same times every||
1479|048|H|day. Continue to take this medication until the full prescribed||
1479|049|H|amount is finished, even if symptoms disappear after a few days.||
1479|050|H|Stopping the medication too early may result in a return of the||
1479|051|H|infection. The dosage and length of treatment are based on your||
1479|052|H|medical condition and response to treatment.||
1479|053|H|   Tell your doctor if your condition lasts or gets worse.||
1479|054|B|||
1479|055|S|SIDE EFFECTS:  Diarrhea, headache, nausea, vomiting, and abnormal||
1479|056|S|taste may occur. If any of these effects last or get worse, tell||
1479|057|S|your doctor or pharmacist promptly.||
1479|058|S|   Remember that this medication has been prescribed because your||
1479|059|S|doctor has judged that the benefit to you is greater than the||
1479|060|S|risk of side effects. Many people using this medication do not||
1479|061|S|have serious side effects.||
1479|062|S|   Tell your doctor right away if you have any serious side||
1479|063|S|effects, including: muscle weakness, signs of liver disease (such||
1479|064|S|as nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
1479|065|S|urine), easy bruising/bleeding, mental/mood changes (such as||
1479|066|S|agitation, confusion), signs of lupus (such as rash on nose and||
1479|067|S|cheeks, new or worsening joint pain), signs of kidney problems||
1479|068|S|(such as change in the amount of urine, pink/bloody urine).||
1479|069|S|   Get medical help right away if you have any very serious side||
1479|070|S|effects, including: severe dizziness, fainting, fast/irregular||
1479|071|S|heartbeat.||
1479|072|S|   This medication may rarely cause a severe intestinal condition||
1479|073|S|due to a bacteria called C. difficile. This condition may occur||
1479|074|S|during treatment or weeks to months after treatment has stopped.||
1479|075|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1479|076|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1479|077|S|stool.||
1479|078|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1479|079|S|products because they may make symptoms worse.||
1479|080|S|   Use of this medication for prolonged or repeated periods may||
1479|081|S|result in oral thrush or a new yeast infection. Contact your||
1479|082|S|doctor if you notice white patches in your mouth, a change in||
1479|083|S|vaginal discharge, or other new symptoms.||
1479|084|S|   A very serious allergic reaction to this drug is rare.||
1479|085|S|However, get medical help right away if you notice any symptoms||
1479|086|S|of a serious allergic reaction, including: fever, swollen lymph||
1479|087|S|nodes, rash, itching/swelling (especially of the||
1479|088|S|face/tongue/throat), severe dizziness, trouble breathing.||
1479|089|S|   Amoxicillin can commonly cause a mild rash that is usually not||
1479|090|S|serious. However, you may not be able to tell it apart from a||
1479|091|S|rare rash that could be a sign of a severe allergic reaction. Get||
1479|092|S|medical help right away if you develop any rash.||
1479|093|S|   This is not a complete list of possible side effects. If you||
1479|094|S|notice other effects not listed above, contact your doctor or||
1479|095|S|pharmacist.||
1479|096|S|   In the US -||
1479|097|S|   Call your doctor for medical advice about side effects. You||
1479|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1479|099|S|www.fda.gov/medwatch.||
1479|100|S|   In Canada - Call your doctor for medical advice about side||
1479|101|S|effects. You may report side effects to Health Canada at||
1479|102|S|1-866-234-2345.||
1479|103|B|||
1479|104|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1479|105|P|pharmacist if you are allergic to omeprazole, amoxicillin, or||
1479|106|P|clarithromycin; or to penicillins (such as ampicillin),||
1479|107|P|cephalosporins (such as cephalexin), or macrolide antibiotics||
1479|108|P|(such as erythromycin), or to proton pump inhibitors (such as||
1479|109|P|esomeprazole); or if you have any other allergies. This product||
1479|110|P|may contain inactive ingredients, which can cause allergic||
1479|111|P|reactions or other problems. Talk to your pharmacist for more||
1479|112|P|details.||
1479|113|P|   Before using this medication, tell your doctor or pharmacist||
1479|114|P|your medical history, especially of: liver disease (including||
1479|115|P|liver problems with past clarithromycin use), kidney disease,||
1479|116|P|heart disease (coronary artery disease, heart attack), a certain||
1479|117|P|type of muscle disease (myasthenia gravis), a certain type of||
1479|118|P|viral infection (infectious mononucleosis), lupus.||
1479|119|P|   Some symptoms may actually be signs of a more serious||
1479|120|P|condition. Get medical help right away if you have: heartburn||
1479|121|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
1479|122|P|pain (especially with shortness of breath, unusual sweating),||
1479|123|P|unexplained weight loss.||
1479|124|P|   Clarithromycin may cause a condition that affects the heart||
1479|125|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1479|126|P|serious (rarely fatal) fast/irregular heartbeat and other||
1479|127|P|symptoms (such as severe dizziness, fainting) that need medical||
1479|128|P|attention right away.||
1479|129|P|   The risk of QT prolongation may be increased if you have||
1479|130|P|certain medical conditions or are taking other drugs that may||
1479|131|P|cause QT prolongation. Before using this product, tell your||
1479|132|P|doctor or pharmacist of all the drugs you take and if you have||
1479|133|P|any of the following conditions: certain heart problems (heart||
1479|134|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1479|135|P|history of certain heart problems (QT prolongation in the EKG,||
1479|136|P|sudden cardiac death).||
1479|137|P|   Low levels of potassium or magnesium in the blood may also||
1479|138|P|increase your risk of QT prolongation. This risk may increase if||
1479|139|P|you use certain drugs (such as diuretics/"water pills") or if you||
1479|140|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1479|141|P|Talk to your doctor about using this product safely.||
1479|142|P|   Before having surgery, tell your doctor or dentist about all||
1479|143|P|the products you use (including prescription drugs,||
1479|144|P|nonprescription drugs, and herbal products).||
1479|145|P|   This medication may cause live bacterial vaccines (such as||
1479|146|P|typhoid vaccine) to not work well. Tell your health care||
1479|147|P|professional that you are using this medication before having any||
1479|148|P|immunizations/vaccinations.||
1479|149|P|   Older adults may be more sensitive to the side effects of this||
1479|150|P|drug, especially QT prolongation (see above), and C. difficile||
1479|151|P|infection (see Side Effects section).||
1479|152|P|   During pregnancy, this product should be used only when||
1479|153|P|clearly needed. Discuss the risks and benefits with your doctor.||
1479|154|P|   Amoxicillin, clarithromycin, and omeprazole pass into breast||
1479|155|P|milk. Consult your doctor before breastfeeding.||
1479|156|B|||
1479|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1479|158|I|medications work or increase your risk for serious side effects.||
1479|159|I|This document does not contain all possible drug interactions.||
1479|160|I|Keep a list of all the products you use (including||
1479|161|I|prescription/nonprescription drugs and herbal products) and share||
1479|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
1479|163|I|the dosage of any medicines without your doctor's approval.||
1479|164|I|   Some products that may interact with this drug include:||
1479|165|I|clopidogrel, methotrexate (especially high-dose treatment), St||
1479|166|I|John's wort.||
1479|167|I|   Many drugs besides clarithromycin may affect the heart rhythm||
1479|168|I|(QT prolongation), including amiodarone, disopyramide,||
1479|169|I|dofetilide, pacritinib, pimozide, procainamide, quinidine,||
1479|170|I|sotalol, among others.||
1479|171|I|   Other medications can affect the removal of clarithromycin||
1479|172|I|from your body, which may affect how clarithromycin works.||
1479|173|I|Examples include rifamycins (such as rifabutin), efavirenz,||
1479|174|I|nevirapine, among others.||
1479|175|I|   Clarithromycin can slow down the removal of other medications||
1479|176|I|from your body, which may affect how they work. Examples of||
1479|177|I|affected drugs include colchicine, digoxin, some drugs used to||
1479|178|I|treat erectile dysfunction-ED/pulmonary hypertension (such as||
1479|179|I|sildenafil, tadalafil), ergot alkaloids (such as ergotamine,||
1479|180|I|dihydroergotamine), flibanserin, some statin drugs (such as||
1479|181|I|lovastatin, simvastatin), tamsulosin, tolvaptan, ticagrelor,||
1479|182|I|among others.||
1479|183|I|   Some products need stomach acid so that the body can absorb||
1479|184|I|them properly. Omeprazole decreases stomach acid, so it may||
1479|185|I|change how well these products work. Some affected products||
1479|186|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
1479|187|I|pazopanib, rilpivirine, sparsentan, certain azole antifungals||
1479|188|I|(itraconazole, ketoconazole, posaconazole), among others.||
1479|189|I|   Omeprazole is very similar to esomeprazole. Do not use any||
1479|190|I|medications containing esomeprazole while using omeprazole.||
1479|191|I|   This medication may interfere with certain lab tests (such as||
1479|192|I|urine glucose test), possibly causing false test results. Make||
1479|193|I|sure lab personnel and all your doctors know you use this drug.||
1479|194|B|||
1479|195|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1479|196|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1479|197|O|poison control center right away. US residents can call||
1479|198|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1479|199|O|Symptoms of overdose may include: change in the amount of urine.||
1479|200|B|||
1479|201|N|NOTES:  Do not share this medication with others.||
1479|202|N|   This medication has been prescribed for your current condition||
1479|203|N|only. Do not use it later for another infection unless your||
1479|204|N|doctor tells you to.||
1479|205|N|   Lab and/or medical tests may be done while you are taking this||
1479|206|N|medication. Keep all medical and lab appointments. Consult your||
1479|207|N|doctor for more details.||
1479|208|B|||
1479|209|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1479|210|D|remember. If it is near the time of the next dose, skip the||
1479|211|D|missed dose. Take your next dose at the regular time. Do not||
1479|212|D|double the dose to catch up.||
1479|213|B|||
1479|214|R|STORAGE:  Store at room temperature away from light and moisture.||
1479|215|R|Do not store in the bathroom. Keep all medications away from||
1479|216|R|children and pets.||
1479|217|R|   Do not flush medications down the toilet or pour them into a||
1479|218|R|drain unless instructed to do so. Properly discard this product||
1479|219|R|when it is expired or no longer needed. Consult your pharmacist||
1479|220|R|or local waste disposal company.||
1479|221|B|||
1479|222|A|Information last revised April 2025.||
1479|223|A|Copyright(c) 2025 First Databank, Inc.||
1479|224|B|||
1480|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1480|002|Z|does NOT have all possible information about this product. This||
1480|003|Z|information does not assure that this product is safe, effective,||
1480|004|Z|or appropriate for you. This information is not individual||
1480|005|Z|medical advice and does not substitute for the advice of your||
1480|006|Z|health care professional. Always ask your health care||
1480|007|Z|professional for complete information about this product and your||
1480|008|Z|specific health needs.||
1480|009|B|||
1480|010|T|OXYCODONE TABLET - ORAL USE ONLY||
1480|011|F|(OX-i-KOE-done)||
1480|012|B|||
1480|013|C|COMMON BRAND NAME(S): Oxaydo, Roxybond||
1480|014|B|||
1480|015|W|WARNING:  Oxycodone has a risk for abuse and addiction, which can||
1480|016|W|lead to overdose and death. Oxycodone may also cause severe,||
1480|017|W|possibly fatal, breathing problems. To lower your risk, your||
1480|018|W|doctor should have you take the smallest dose of oxycodone that||
1480|019|W|works, and take it for the shortest possible time. See also How||
1480|020|W|to Use section for more information about addiction.||
1480|021|W|   Ask your doctor or pharmacist if you should have medication||
1480|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1480|023|W|Teach your family or household members about the signs of an||
1480|024|W|opioid overdose and how to treat it.||
1480|025|W|   The risk for severe breathing problems is higher when you||
1480|026|W|start this medication and after a dose increase, or if you take||
1480|027|W|the wrong dose/strength. Taking this medication with alcohol or||
1480|028|W|other drugs that can cause drowsiness or breathing problems may||
1480|029|W|cause very serious side effects, including death. Also, other||
1480|030|W|medications can affect the removal of oxycodone from your body,||
1480|031|W|which may affect how oxycodone works. Be sure you know how to||
1480|032|W|take oxycodone and what other drugs you should avoid taking with||
1480|033|W|it. See also Drug Interactions section. Get medical help right||
1480|034|W|away if any of these very serious side effects occur:||
1480|035|W|slow/shallow breathing, unusual lightheadedness, severe||
1480|036|W|drowsiness/dizziness, difficulty waking up.||
1480|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1480|038|W|or abuse. If someone accidentally swallows this drug, get medical||
1480|039|W|help right away.||
1480|040|W|   Before using this medication, women of childbearing age should||
1480|041|W|talk with their doctor(s) about the risks and benefits. Tell your||
1480|042|W|doctor if you are pregnant or if you plan to become pregnant.||
1480|043|W|During pregnancy, this medication should be used only when||
1480|044|W|clearly needed. It may slightly increase the risk of birth||
1480|045|W|defects if used during the first two months of pregnancy. Also,||
1480|046|W|using it for a long time or in high doses near the expected||
1480|047|W|delivery date may harm the unborn baby. To lessen the risk, take||
1480|048|W|the smallest effective dose for the shortest possible time.||
1480|049|W|Babies born to mothers who use this drug for a long time may||
1480|050|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1480|051|W|doctor right away if you notice any symptoms in your newborn baby||
1480|052|W|such as crying that doesn't stop, slow/shallow breathing,||
1480|053|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1480|054|W|difficulty gaining weight.||
1480|055|B|||
1480|056|U|USES:  This medication is used to help relieve moderate to severe||
1480|057|U|pain. Oxycodone belongs to a class of drugs known as opioid||
1480|058|U|analgesics. It works in the brain to change how your body feels||
1480|059|U|and responds to pain.||
1480|060|B|||
1480|061|H|HOW TO USE:  Read the Medication Guide provided by your||
1480|062|H|pharmacist before you start taking oxycodone and each time you||
1480|063|H|get a refill. If you have any questions, ask your doctor or||
1480|064|H|pharmacist.||
1480|065|H|   Take this medication only by mouth as directed by your doctor.||
1480|066|H|You may take this drug with or without food. If you have nausea,||
1480|067|H|it may help to take this drug with food. Ask your doctor or||
1480|068|H|pharmacist about other ways to decrease nausea (such as lying||
1480|069|H|down for 1 to 2 hours with as little head movement as possible).||
1480|070|H|   Swallow this medication whole with plenty of water. This||
1480|071|H|tablet should not be given down a feeding tube. This tablet, even||
1480|072|H|if crushed or dissolved, will clog a feeding tube. Do not crush,||
1480|073|H|chew, or dissolve these tablets before taking.||
1480|074|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1480|075|H|using this medication unless your doctor or pharmacist says you||
1480|076|H|may do so safely. Grapefruit can increase the chance of side||
1480|077|H|effects with this medicine. Ask your doctor or pharmacist for||
1480|078|H|more details.||
1480|079|H|   The dosage is based on your medical condition and response to||
1480|080|H|treatment. Do not increase your dose, take the medication more||
1480|081|H|often, or take it for a longer time than prescribed. Properly||
1480|082|H|stop the medication when so directed.||
1480|083|H|   Pain medications work best if they are used when the first||
1480|084|H|signs of pain occur. If you wait until the pain has worsened, the||
1480|085|H|medication may not work as well.||
1480|086|H|   If you have ongoing pain (such as due to cancer), your doctor||
1480|087|H|may direct you to also take long-acting opioid medications. In||
1480|088|H|that case, this medication might be used for sudden||
1480|089|H|(breakthrough) pain only as needed. Other pain relievers (such as||
1480|090|H|acetaminophen, ibuprofen) may also be prescribed with this||
1480|091|H|medication. Ask your doctor or pharmacist about using oxycodone||
1480|092|H|safely with other drugs.||
1480|093|H|   Suddenly stopping this medication may cause withdrawal,||
1480|094|H|especially if you have used it for a long time or in high doses.||
1480|095|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1480|096|H|Tell your doctor or pharmacist right away if you have any||
1480|097|H|withdrawal symptoms such as restlessness, mental/mood changes||
1480|098|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1480|099|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1480|100|H|aches, or sudden changes in behavior.||
1480|101|H|   When this medication is used for a long time, it may not work||
1480|102|H|as well. Talk with your doctor if this medication stops working||
1480|103|H|well.||
1480|104|H|   Though it helps many people, this medication may sometimes||
1480|105|H|cause addiction. This risk may be higher if you have a||
1480|106|H|mental/mood disorder or a substance use disorder (such as overuse||
1480|107|H|of or addiction to drugs/alcohol). Take this medication exactly||
1480|108|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1480|109|H|pharmacist for more details.||
1480|110|H|   Tell your doctor if your pain does not get better or if it||
1480|111|H|gets worse, or if you have any new pain.||
1480|112|B|||
1480|113|S|SIDE EFFECTS:  See also Warning section.||
1480|114|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
1480|115|S|drowsiness may occur. Some of these side effects may decrease||
1480|116|S|after you have been using this medication for a while. If any of||
1480|117|S|these effects last or get worse, tell your doctor or pharmacist||
1480|118|S|promptly.||
1480|119|S|   To prevent constipation, eat dietary fiber, drink enough||
1480|120|S|water, and exercise. You may also need to take a laxative. Ask||
1480|121|S|your pharmacist which type of laxative is right for you.||
1480|122|S|   To reduce the risk of dizziness and lightheadedness, get up||
1480|123|S|slowly when rising from a sitting or lying position.||
1480|124|S|   An empty tablet shell may appear in your stool. This effect is||
1480|125|S|harmless because your body has already absorbed the medication.||
1480|126|S|   Remember that this medication has been prescribed because your||
1480|127|S|doctor has judged that the benefit to you is greater than the||
1480|128|S|risk of side effects. Many people using this medication do not||
1480|129|S|have serious side effects.||
1480|130|S|   Tell your doctor right away if you have any serious side||
1480|131|S|effects, including: interrupted breathing during sleep (sleep||
1480|132|S|apnea), mental/mood changes (such as agitation, confusion,||
1480|133|S|hallucinations), severe stomach/abdominal pain, difficulty||
1480|134|S|urinating, signs of your adrenal glands not working well (such as||
1480|135|S|loss of appetite, unusual tiredness, weight loss), trouble||
1480|136|S|swallowing.||
1480|137|S|   Get medical help right away if you have any serious side||
1480|138|S|effects, including: fainting, seizure, slow/shallow breathing,||
1480|139|S|severe drowsiness/difficulty waking up.||
1480|140|S|   A very serious allergic reaction to this drug is rare.||
1480|141|S|However, get medical help right away if you notice any symptoms||
1480|142|S|of a serious allergic reaction, including: rash, itching/swelling||
1480|143|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1480|144|S|breathing.||
1480|145|S|   This is not a complete list of possible side effects. If you||
1480|146|S|notice other effects not listed above, contact your doctor or||
1480|147|S|pharmacist.||
1480|148|S|   In the US -||
1480|149|S|   Call your doctor for medical advice about side effects. You||
1480|150|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1480|151|S|www.fda.gov/medwatch.||
1480|152|S|   In Canada - Call your doctor for medical advice about side||
1480|153|S|effects. You may report side effects to Health Canada at||
1480|154|S|1-866-234-2345.||
1480|155|B|||
1480|156|P|PRECAUTIONS:  Before taking oxycodone, tell your doctor or||
1480|157|P|pharmacist if you are allergic to it; or to other opioid pain||
1480|158|P|relievers (such as oxymorphone); or if you have any other||
1480|159|P|allergies. This product may contain inactive ingredients, which||
1480|160|P|can cause allergic reactions or other problems. Talk to your||
1480|161|P|pharmacist for more details.||
1480|162|P|   Before using this medication, tell your doctor or pharmacist||
1480|163|P|your medical history, especially of: brain disorders (such as||
1480|164|P|head injury, tumor, seizures), breathing problems (such as||
1480|165|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1480|166|P|kidney disease, liver disease, mental/mood disorders (such as||
1480|167|P|confusion, depression), personal or family history of a substance||
1480|168|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
1480|169|P|stomach/intestinal problems (such as blockage, constipation,||
1480|170|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
1480|171|P|(such as due to enlarged prostate), gallbladder disease, disease||
1480|172|P|of the pancreas (pancreatitis).||
1480|173|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1480|174|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1480|175|P|machinery, or do anything that needs alertness until you can do||
1480|176|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1480|177|P|are using marijuana (cannabis).||
1480|178|P|   Before having surgery, tell your doctor or dentist about all||
1480|179|P|the products you use (including prescription drugs,||
1480|180|P|nonprescription drugs, and herbal products).||
1480|181|P|   Older adults may be more sensitive to the side effects of this||
1480|182|P|drug, especially confusion, dizziness, drowsiness, and||
1480|183|P|slow/shallow breathing.||
1480|184|P|   During pregnancy, this medication should be used only when||
1480|185|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1480|186|P|benefits with your doctor. (See also Warning section.)||
1480|187|P|   This drug passes into breast milk and may have undesirable||
1480|188|P|effects on a nursing infant. Tell the doctor right away if your||
1480|189|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1480|190|P|breathing. Consult your doctor before breastfeeding.||
1480|191|B|||
1480|192|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
1480|193|I|   Drug interactions may change how your medications work or||
1480|194|I|increase your risk for serious side effects. This document does||
1480|195|I|not contain all possible drug interactions. Keep a list of all||
1480|196|I|the products you use (including prescription/nonprescription||
1480|197|I|drugs and herbal products) and share it with your doctor and||
1480|198|I|pharmacist. Do not start, stop, or change the dosage of any||
1480|199|I|medicines without your doctor's approval.||
1480|200|I|   Some products that may interact with this drug include:||
1480|201|I|certain pain medications (mixed opioid agonist/antagonists such||
1480|202|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1480|203|I|samidorphan.||
1480|204|I|   The risk of serious side effects (such as slow/shallow||
1480|205|I|breathing, severe drowsiness/dizziness) may be increased if this||
1480|206|I|medication is taken with other products that may also cause||
1480|207|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1480|208|I|if you are taking other products such as other opioid pain or||
1480|209|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1480|210|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1480|211|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1480|212|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1480|213|I|cetirizine, diphenhydramine).||
1480|214|I|   Check the labels on all your medicines (such as allergy or||
1480|215|I|cough-and-cold products) because they may contain ingredients||
1480|216|I|that cause drowsiness. Ask your pharmacist about using those||
1480|217|I|products safely.||
1480|218|I|   Other medications can affect the removal of oxycodone from||
1480|219|I|your body, which may affect how oxycodone works. Examples include||
1480|220|I|azole antifungals (such as ketoconazole), macrolide antibiotics||
1480|221|I|(such as erythromycin), mifepristone, HIV medications (such as||
1480|222|I|tipranavir), rifamycins (such as rifabutin, rifampin), ritonavir,||
1480|223|I|certain drugs used to treat seizures (such as carbamazepine,||
1480|224|I|phenytoin), among others.||
1480|225|I|   This medication may interfere with certain lab tests (such as||
1480|226|I|amylase/lipase levels), possibly causing false test results. Make||
1480|227|I|sure lab personnel and all your doctors know you use this drug.||
1480|228|B|||
1480|229|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1480|230|O|as passing out or trouble breathing, give them naloxone or||
1480|231|O|nalmefene if available, then call 911. If the person is awake and||
1480|232|O|has no symptoms, call a poison control center right away. US||
1480|233|O|residents can call 1-800-222-1222. Canada residents can call||
1480|234|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1480|235|O|breathing, slow heartbeat, coma.||
1480|236|B|||
1480|237|N|NOTES:  Do not share this medication with others. Sharing it is||
1480|238|N|against the law.||
1480|239|N|   This medication has been prescribed for your current condition||
1480|240|N|only. Do not use it later for another condition unless told to do||
1480|241|N|so by your doctor. A different medication may be necessary in||
1480|242|N|that case.||
1480|243|B|||
1480|244|D|MISSED DOSE:  If you are taking this medication on a regular||
1480|245|D|schedule and miss a dose, take it as soon as you remember. If it||
1480|246|D|is near the time of the next dose, skip the missed dose. Take||
1480|247|D|your next dose at the regular time. Do not double the dose to||
1480|248|D|catch up.||
1480|249|B|||
1480|250|R|STORAGE:  Store at room temperature away from light and moisture.||
1480|251|R|Do not store in the bathroom. Keep all medications away from||
1480|252|R|children and pets.||
1480|253|R|   Do not flush medications down the toilet or pour them into a||
1480|254|R|drain unless instructed to do so. Properly discard this product||
1480|255|R|when it is expired or no longer needed. For more details, read||
1480|256|R|the Medication Guide, or consult your pharmacist or local waste||
1480|257|R|disposal company.||
1480|258|B|||
1480|259|A|Information last revised August 2025.||
1480|260|A|Copyright(c) 2025 First Databank, Inc.||
1480|261|B|||
1481|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1481|002|Z|does NOT have all possible information about this product. This||
1481|003|Z|information does not assure that this product is safe, effective,||
1481|004|Z|or appropriate for you. This information is not individual||
1481|005|Z|medical advice and does not substitute for the advice of your||
1481|006|Z|health care professional. Always ask your health care||
1481|007|Z|professional for complete information about this product and your||
1481|008|Z|specific health needs.||
1481|009|B|||
1481|010|T|AZELASTINE/FLUTICASONE SPRAY - NASAL||
1481|011|F|(AY-ze-LAS-teen/floo-TIK-a-sone)||
1481|012|B|||
1481|013|C|COMMON BRAND NAME(S): Dymista||
1481|014|B|||
1481|015|U|USES:  This product is used to relieve seasonal allergy symptoms||
1481|016|U|of the nose such as stuffy/runny nose, itching, sneezing, and||
1481|017|U|post-nasal drip. It contains 2 drugs. Azelastine is an||
1481|018|U|antihistamine that works by blocking certain natural substances||
1481|019|U|called histamines that are responsible for allergic symptoms.||
1481|020|U|Fluticasone belongs to a class of drugs known as corticosteroids.||
1481|021|U|It works by reducing swelling (inflammation) in the nasal||
1481|022|U|passages.||
1481|023|B|||
1481|024|V|OTHER USES:  This section contains uses of this drug that are not||
1481|025|V|listed in the approved professional labeling for the drug but||
1481|026|V|that may be prescribed by your health care professional. Use this||
1481|027|V|drug for a condition that is listed in this section only if it||
1481|028|V|has been so prescribed by your health care professional.||
1481|029|V|   This medication may also be used for similar nasal symptoms||
1481|030|V|caused by other allergic and non-allergic conditions.||
1481|031|B|||
1481|032|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1481|033|H|your pharmacist before you start using azelastine/fluticasone and||
1481|034|H|each time you get a refill. Follow the illustrated directions for||
1481|035|H|the proper use of this medication. If you have any questions, ask||
1481|036|H|your doctor or pharmacist.||
1481|037|H|   Gently blow your nose before using this product. Shake the||
1481|038|H|container gently before using. Follow the instructions for test||
1481|039|H|sprays in the air if you are using the container for the first||
1481|040|H|time or if you have not used it for awhile (for example, more||
1481|041|H|than 1 week). Check your product package for instructions on when||
1481|042|H|you need to do the test sprays again if you have not used the||
1481|043|H|container in awhile.||
1481|044|H|   Use this medication in the nose as directed by your doctor,||
1481|045|H|usually twice a day in both nostrils. Do not spray it in your||
1481|046|H|eyes or mouth. If this medication gets in your eyes, flush them||
1481|047|H|thoroughly with water.||
1481|048|H|   Use this medication regularly to get the most benefit from it.||
1481|049|H|To help you remember, use it at the same times each day.||
1481|050|H|   Do not increase your dose or use this drug more often or for||
1481|051|H|longer than prescribed. Your condition will not improve any||
1481|052|H|faster, and your risk of side effects will increase.||
1481|053|H|   Clean the applicator regularly. Keep track of the number of||
1481|054|H|sprays used from the container. Discard the container after you||
1481|055|H|have used the number of sprays specified on the manufacturer's||
1481|056|H|package.||
1481|057|H|   You may feel the product start to work as soon as 30 minutes||
1481|058|H|after the first dose, but it may take several days before you get||
1481|059|H|the full benefit of this product. Tell your doctor if you do not||
1481|060|H|get better or if you get worse.||
1481|061|B|||
1481|062|S|SIDE EFFECTS:  Drowsiness, nasal dryness/irritation, mild||
1481|063|S|nosebleeds, or a change in the sense of taste may occur. If any||
1481|064|S|of these effects last or get worse, tell your doctor or||
1481|065|S|pharmacist promptly.||
1481|066|S|   Remember that this medication has been prescribed because your||
1481|067|S|doctor has judged that the benefit to you is greater than the||
1481|068|S|risk of side effects. Many people using this medication do not||
1481|069|S|have serious side effects.||
1481|070|S|   Tell your doctor right away if you have any serious side||
1481|071|S|effects, including: severe nosebleeds, pain in your nose, a||
1481|072|S|whistling sound when you breathe, eye pain, signs of infection||
1481|073|S|(such as sore throat that doesn't go away, white patches in your||
1481|074|S|nose/back of your throat, fever, chills).||
1481|075|S|   Rarely, it is possible that corticosteroids given in the nose||
1481|076|S|will be absorbed into the bloodstream. This can lead to side||
1481|077|S|effects of too much corticosteroid. These side effects are more||
1481|078|S|likely in children and people who use this medication for a long||
1481|079|S|time and in high doses. Tell your doctor right away if any of the||
1481|080|S|following side effects occur: unusual/extreme tiredness, weight||
1481|081|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
1481|082|S|vision problems.||
1481|083|S|   A very serious allergic reaction to this drug is rare.||
1481|084|S|However, get medical help right away if you notice any symptoms||
1481|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1481|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1481|087|S|breathing.||
1481|088|S|   This is not a complete list of possible side effects. If you||
1481|089|S|notice other effects not listed above, contact your doctor or||
1481|090|S|pharmacist.||
1481|091|S|   In the US -||
1481|092|S|   Call your doctor for medical advice about side effects. You||
1481|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1481|094|S|www.fda.gov/medwatch.||
1481|095|S|   In Canada - Call your doctor for medical advice about side||
1481|096|S|effects. You may report side effects to Health Canada at||
1481|097|S|1-866-234-2345.||
1481|098|B|||
1481|099|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1481|100|P|pharmacist if you are allergic to azelastine or fluticasone; or||
1481|101|P|if you have any other allergies. This product may contain||
1481|102|P|inactive ingredients, which can cause allergic reactions or other||
1481|103|P|problems. Talk to your pharmacist for more details.||
1481|104|P|   Before using this medication, tell your doctor or pharmacist||
1481|105|P|your medical history, especially of: recent nose problems (such||
1481|106|P|as injury, ulcers, surgery), current/past infections (including||
1481|107|P|tuberculosis, herpes eye infection), certain eye problems||
1481|108|P|(glaucoma, cataracts).||
1481|109|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
1481|110|P|can make you more drowsy. Do not drive, use machinery, or do||
1481|111|P|anything that needs alertness until you can do it safely. Avoid||
1481|112|P|alcoholic beverages. Talk to your doctor if you are using||
1481|113|P|marijuana (cannabis).||
1481|114|P|   Stay away from anyone who has an infection that may easily||
1481|115|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1481|116|P|doctor if you have been exposed to an infection or for more||
1481|117|P|details.||
1481|118|P|   Rarely, using corticosteroid medications for a long time can||
1481|119|P|make it more difficult for your body to respond to physical||
1481|120|P|stress. Before having surgery or emergency treatment, or if you||
1481|121|P|get a serious illness/injury, tell your doctor or dentist that||
1481|122|P|you are using this medication or have used this medication within||
1481|123|P|the past few months.||
1481|124|P|   Though it is unlikely, this medication may temporarily slow||
1481|125|P|down a child's growth if used for a long time. See the doctor||
1481|126|P|regularly so your child's height can be checked.||
1481|127|P|   During pregnancy, this medication should be used only when||
1481|128|P|clearly needed. Discuss the risks and benefits with your doctor.||
1481|129|P|   It is unknown if this drug passes into breast milk. Consult||
1481|130|P|your doctor before breastfeeding.||
1481|131|B|||
1481|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1481|133|I|medications work or increase your risk for serious side effects.||
1481|134|I|This document does not contain all possible drug interactions.||
1481|135|I|Keep a list of all the products you use (including||
1481|136|I|prescription/nonprescription drugs and herbal products) and share||
1481|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
1481|138|I|the dosage of any medicines without your doctor's approval.||
1481|139|I|   Some products that may interact with this drug include: HIV||
1481|140|I|protease inhibitors (such as lopinavir), ritonavir.||
1481|141|I|   Tell your doctor or pharmacist if you are taking other||
1481|142|I|products that cause drowsiness such as opioid pain or cough||
1481|143|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1481|144|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1481|145|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1481|146|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1481|147|I|diphenhydramine).||
1481|148|I|   Check the labels on all your medicines (such as allergy or||
1481|149|I|cough-and-cold products) because they may contain ingredients||
1481|150|I|that cause drowsiness. Ask your pharmacist about using those||
1481|151|I|products safely.||
1481|152|B|||
1481|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1481|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1481|155|O|poison control center right away. US residents can call||
1481|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1481|157|B|||
1481|158|N|NOTES:  Do not share this medication with others.||
1481|159|N|   If you use this medication for a long time, lab and/or medical||
1481|160|N|tests (such as nose exams, height measurement in children) may be||
1481|161|N|done while you are using this medication. Keep all medical and||
1481|162|N|lab appointments.||
1481|163|N|   Ask your doctor for ways to reduce your exposure to substances||
1481|164|N|(such as pollen, pet dander, dust mites, mold, smoke) that can||
1481|165|N|worsen allergy symptoms.||
1481|166|B|||
1481|167|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1481|168|D|If it is near the time of the next dose, skip the missed dose.||
1481|169|D|Use your next dose at the regular time. Do not double the dose to||
1481|170|D|catch up.||
1481|171|B|||
1481|172|R|STORAGE:  Store the container upright at room temperature away||
1481|173|R|from light. Keep all medications away from children and pets.||
1481|174|R|   Do not flush medications down the toilet or pour them into a||
1481|175|R|drain unless instructed to do so. Properly discard this product||
1481|176|R|when it is expired or no longer needed. Some brands should be||
1481|177|R|thrown away after 6 months of use. Check the product package of||
1481|178|R|your brand. Consult your pharmacist or local waste disposal||
1481|179|R|company.||
1481|180|B|||
1481|181|A|Information last revised May 2024.||
1481|182|A|Copyright(c) 2025 First Databank, Inc.||
1481|183|B|||
1482|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1482|002|Z|does NOT have all possible information about this product. This||
1482|003|Z|information does not assure that this product is safe, effective,||
1482|004|Z|or appropriate for you. This information is not individual||
1482|005|Z|medical advice and does not substitute for the advice of your||
1482|006|Z|health care professional. Always ask your health care||
1482|007|Z|professional for complete information about this product and your||
1482|008|Z|specific health needs.||
1482|009|B|||
1482|010|T|PERTUZUMAB - INJECTION||
1482|011|F|(per-TOOZ-ue-mab)||
1482|012|B|||
1482|013|C|COMMON BRAND NAME(S): Perjeta||
1482|014|B|||
1482|015|W|WARNING:  This medication may cause serious heart problems,||
1482|016|W|including heart failure. The risk of heart problems is increased||
1482|017|W|if you also use an anthracycline (such as doxorubicin). Your||
1482|018|W|doctor may stop treatment with this medication if heart problems||
1482|019|W|occur. Tell your doctor right away if you have any symptoms of||
1482|020|W|heart failure (such as shortness of breath, swelling ankles/feet,||
1482|021|W|unusual tiredness, unusual/sudden weight gain).||
1482|022|W|   Pertuzumab can cause serious (possibly fatal) harm to an||
1482|023|W|unborn baby if used during pregnancy. Your doctor should order a||
1482|024|W|pregnancy test before you start this medication. It is important||
1482|025|W|to prevent pregnancy while taking this medication. Consult your||
1482|026|W|doctor for more details and to discuss the use of reliable forms||
1482|027|W|of birth control while using this medication and for 7 months||
1482|028|W|after the last dose. If you are planning pregnancy, become||
1482|029|W|pregnant, or think you may be pregnant, tell your doctor right||
1482|030|W|away.||
1482|031|B|||
1482|032|U|USES:  Pertuzumab is used to treat breast cancer. Pertuzumab||
1482|033|U|belongs to a class of drugs known as monoclonal antibodies. It||
1482|034|U|works by slowing or stopping the growth of cancer cells.||
1482|035|B|||
1482|036|H|HOW TO USE:  This medication is given by a health care||
1482|037|H|professional. It is injected slowly into a vein as directed by||
1482|038|H|your doctor, usually once every 3 weeks. Your first infusion will||
1482|039|H|be given over 60 minutes.||
1482|040|H|   The dosage, the speed of your injection, and the length of||
1482|041|H|time you receive pertuzumab is based on your medical condition,||
1482|042|H|other treatments you are taking, and your response to pertuzumab||
1482|043|H|treatment.||
1482|044|H|   Infusion reactions may happen during the infusion of this||
1482|045|H|drug. Tell your doctor right away if you have any symptoms of||
1482|046|H|infusion reactions such as chills, fever, headache, rash,||
1482|047|H|vomiting, or weakness. Your doctor may give you other medications||
1482|048|H|to help with these side effects or may slow down or stop your||
1482|049|H|treatment for some time.||
1482|050|H|   Use this medication regularly to get the most benefit from it.||
1482|051|H|To help you remember, mark your calendar with a reminder.||
1482|052|B|||
1482|053|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1482|054|S|   Diarrhea, nausea, vomiting, tiredness, and loss of appetite||
1482|055|S|may occur. If any of these effects last or get worse, tell your||
1482|056|S|doctor or pharmacist promptly.||
1482|057|S|   Temporary hair loss may occur. Normal hair growth should||
1482|058|S|return after treatment has ended.||
1482|059|S|   Remember that this medication has been prescribed because your||
1482|060|S|doctor has judged that the benefit to you is greater than the||
1482|061|S|risk of side effects. Many people using this medication do not||
1482|062|S|have serious side effects.||
1482|063|S|   Tell your doctor right away if you have any serious side||
1482|064|S|effects, including: trouble breathing, numbness/tingling of||
1482|065|S|arms/legs.||
1482|066|S|   Pertuzumab can commonly cause a rash that is usually not||
1482|067|S|serious. However, you may not be able to tell it apart from a||
1482|068|S|rare rash that could be a sign of a severe reaction. Tell your||
1482|069|S|doctor right away if you develop any rash.||
1482|070|S|   This medication may lower your ability to fight infections.||
1482|071|S|This may make you more likely to get a serious (rarely fatal)||
1482|072|S|infection or make any infection you have worse. Tell your doctor||
1482|073|S|right away if you have any signs of infection (such as sore||
1482|074|S|throat that doesn't go away, fever, chills).||
1482|075|S|   A very serious allergic reaction to this drug is rare.||
1482|076|S|However, get medical help right away if you notice any symptoms||
1482|077|S|of a serious allergic reaction, including: rash, itching/swelling||
1482|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1482|079|S|breathing.||
1482|080|S|   This is not a complete list of possible side effects. If you||
1482|081|S|notice other effects not listed above, contact your doctor or||
1482|082|S|pharmacist.||
1482|083|S|   In the US -||
1482|084|S|   Call your doctor for medical advice about side effects. You||
1482|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1482|086|S|www.fda.gov/medwatch.||
1482|087|S|   In Canada - Call your doctor for medical advice about side||
1482|088|S|effects. You may report side effects to Health Canada at||
1482|089|S|1-866-234-2345.||
1482|090|B|||
1482|091|P|PRECAUTIONS:  See also Warning section.||
1482|092|P|   Before using pertuzumab, tell your doctor or pharmacist if you||
1482|093|P|are allergic to it; or if you have any other allergies. This||
1482|094|P|product may contain inactive ingredients, which can cause||
1482|095|P|allergic reactions or other problems. Talk to your pharmacist for||
1482|096|P|more details.||
1482|097|P|   Before using this medication, tell your doctor or pharmacist||
1482|098|P|your medical history, especially of: previous cancer treatments||
1482|099|P|(including radiation therapy to the chest), heart disease, high||
1482|100|P|blood pressure, previous severe reaction to monoclonal antibody||
1482|101|P|treatment.||
1482|102|P|   Pertuzumab can make you more likely to get infections or may||
1482|103|P|make current infections worse. Stay away from anyone who has an||
1482|104|P|infection that may easily spread (such as chickenpox, COVID-19,||
1482|105|P|measles, flu). Talk to your doctor if you have been exposed to an||
1482|106|P|infection or for more details.||
1482|107|P|   Tell your health care professional that you are using||
1482|108|P|pertuzumab before having any immunizations/vaccinations. Avoid||
1482|109|P|contact with people who have recently received live vaccines||
1482|110|P|(such as flu vaccine inhaled through the nose).||
1482|111|P|   To lower the chance of getting cut, bruised, or injured, use||
1482|112|P|caution with sharp objects like razors and nail cutters, and||
1482|113|P|avoid activities such as contact sports.||
1482|114|P|   Before having surgery, tell your doctor or dentist about all||
1482|115|P|the products you use (including prescription drugs,||
1482|116|P|nonprescription drugs, and herbal products).||
1482|117|P|   Older adults may be more sensitive to the side effects of this||
1482|118|P|drug, especially tiredness, loss of appetite and||
1482|119|P|numbness/tingling of arms/legs.||
1482|120|P|   Tell your doctor if you are pregnant or plan to become||
1482|121|P|pregnant. You should not become pregnant while using pertuzumab.||
1482|122|P|Pertuzumab may harm an unborn baby.||
1482|123|P|   It is unknown if this medication passes into breast milk.||
1482|124|P|Because of the possible risk to the infant, breastfeeding is not||
1482|125|P|recommended while using this medication and for 7 months after||
1482|126|P|the last dose. Consult your doctor before breastfeeding.||
1482|127|B|||
1482|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1482|129|I|medications work or increase your risk for serious side effects.||
1482|130|I|This document does not contain all possible drug interactions.||
1482|131|I|Keep a list of all the products you use (including||
1482|132|I|prescription/nonprescription drugs and herbal products) and share||
1482|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
1482|134|I|the dosage of any medicines without your doctor's approval.||
1482|135|B|||
1482|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1482|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1482|138|O|poison control center right away. US residents can call||
1482|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1482|140|B|||
1482|141|N|NOTES:  Do not share this medication with others.||
1482|142|N|   Lab and/or medical tests (such as heart exams) should be done||
1482|143|N|before you start using this medication and while you are using||
1482|144|N|it. Keep all medical and lab appointments. Consult your doctor||
1482|145|N|for more details.||
1482|146|B|||
1482|147|D|MISSED DOSE:  It is important to get each dose of this medication||
1482|148|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1482|149|D|right away for a new dosing schedule.||
1482|150|B|||
1482|151|R|STORAGE:  Not applicable. This medication is given in a hospital||
1482|152|R|or clinic and will not be stored at home.||
1482|153|B|||
1482|154|M|MEDICAL ALERT:  Your condition can cause complications in a||
1482|155|M|medical emergency. For information about enrolling in MedicAlert,||
1482|156|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1482|157|B|||
1482|158|A|Information last revised April 2025.||
1482|159|A|Copyright(c) 2025 First Databank, Inc.||
1482|160|B|||
1483|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1483|002|Z|does NOT have all possible information about this product. This||
1483|003|Z|information does not assure that this product is safe, effective,||
1483|004|Z|or appropriate for you. This information is not individual||
1483|005|Z|medical advice and does not substitute for the advice of your||
1483|006|Z|health care professional. Always ask your health care||
1483|007|Z|professional for complete information about this product and your||
1483|008|Z|specific health needs.||
1483|009|B|||
1483|010|T|CICLESONIDE HFA SPRAY - NASAL||
1483|011|F|(sye-KLES-oh-nide)||
1483|012|B|||
1483|013|C|COMMON BRAND NAME(S): Zetonna||
1483|014|B|||
1483|015|U|USES:  Ciclesonide is used to relieve seasonal and year-round||
1483|016|U|allergy symptoms of the nose such as stuffy/runny nose, itching,||
1483|017|U|and sneezing. This medication belongs to a class of drugs known||
1483|018|U|as corticosteroids. It works by reducing swelling (inflammation)||
1483|019|U|in the nasal passages.||
1483|020|B|||
1483|021|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1483|022|H|your pharmacist before you start using ciclesonide nasal spray||
1483|023|H|and each time you get a refill. Follow the instructions on how to||
1483|024|H|properly use this medication. If you have any questions, ask your||
1483|025|H|doctor or pharmacist.||
1483|026|H|   Gently blow your nose before using this drug. Follow the||
1483|027|H|instructions on how to properly prime the canister if you are||
1483|028|H|using it for the first time, if you have not used it for 10 days||
1483|029|H|or more, or if the canister and actuator become separated.||
1483|030|H|   Use this medication in the nose as directed by your doctor,||
1483|031|H|usually once a day in both nostrils. Do not use more than 1 spray||
1483|032|H|in each nostril daily as this may increase the risk of side||
1483|033|H|effects. Do not spray this medication in your eyes or directly||
1483|034|H|onto the nasal septum (the wall between your nostrils).||
1483|035|H|   Use this medication regularly to get the most benefit from it.||
1483|036|H|To help you remember, use it at the same time each day.||
1483|037|H|   Clean the outside of the nose piece regularly with a clean dry||
1483|038|H|tissue. Keep track of the number of sprays used from the||
1483|039|H|container with the dose indicator. Discard the container after||
1483|040|H|the dose indicator reads zero.||
1483|041|H|   You may feel the drug start to work within 2 days, but it may||
1483|042|H|take 1 to 2 weeks before the full benefit of this drug takes||
1483|043|H|effect. Tell your doctor if your condition does not get better or||
1483|044|H|if it gets worse.||
1483|045|B|||
1483|046|S|SIDE EFFECTS:  Nasal dryness/irritation or mild nosebleeds may||
1483|047|S|occur. If any of these effects last or get worse, tell your||
1483|048|S|doctor or pharmacist promptly.||
1483|049|S|   Remember that this medication has been prescribed because your||
1483|050|S|doctor has judged that the benefit to you is greater than the||
1483|051|S|risk of side effects. Many people using this medication do not||
1483|052|S|have serious side effects.||
1483|053|S|   Tell your doctor right away if you have any serious side||
1483|054|S|effects, including: severe nosebleeds, pain in your nose, a||
1483|055|S|whistling sound when you breathe, eye pain, signs of infection||
1483|056|S|(such as sore throat that doesn't go away, white patches in your||
1483|057|S|nose/back of your throat, fever, chills).||
1483|058|S|   Rarely, it is possible that corticosteroids given in the nose||
1483|059|S|will be absorbed into the bloodstream. This can lead to side||
1483|060|S|effects of too much corticosteroid. These side effects are more||
1483|061|S|likely in children and people who use this medication for a long||
1483|062|S|time and in high doses. Tell your doctor right away if any of the||
1483|063|S|following side effects occur: unusual/extreme tiredness, weight||
1483|064|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
1483|065|S|vision problems.||
1483|066|S|   A very serious allergic reaction to this drug is rare.||
1483|067|S|However, get medical help right away if you notice any symptoms||
1483|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1483|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1483|070|S|breathing.||
1483|071|S|   This is not a complete list of possible side effects. If you||
1483|072|S|notice other effects not listed above, contact your doctor or||
1483|073|S|pharmacist.||
1483|074|S|   In the US -||
1483|075|S|   Call your doctor for medical advice about side effects. You||
1483|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1483|077|S|www.fda.gov/medwatch.||
1483|078|S|   In Canada - Call your doctor for medical advice about side||
1483|079|S|effects. You may report side effects to Health Canada at||
1483|080|S|1-866-234-2345.||
1483|081|B|||
1483|082|P|PRECAUTIONS:  Before using ciclesonide, tell your doctor or||
1483|083|P|pharmacist if you are allergic to it; or if you have any other||
1483|084|P|allergies. This product may contain inactive ingredients, which||
1483|085|P|can cause allergic reactions or other problems. Talk to your||
1483|086|P|pharmacist for more details.||
1483|087|P|   Before using this medication, tell your doctor or pharmacist||
1483|088|P|your medical history, especially of: recent nose problems (such||
1483|089|P|as injury, ulcers, surgery), current/past infections (including||
1483|090|P|tuberculosis, herpes eye infection), certain eye problems||
1483|091|P|(glaucoma, cataracts).||
1483|092|P|   Stay away from anyone who has an infection that may easily||
1483|093|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1483|094|P|doctor if you have been exposed to an infection or for more||
1483|095|P|details.||
1483|096|P|   Rarely, using corticosteroid medications for a long time can||
1483|097|P|make it more difficult for your body to respond to physical||
1483|098|P|stress. Before having surgery or emergency treatment, or if you||
1483|099|P|get a serious illness/injury, tell your doctor or dentist that||
1483|100|P|you are using this medication or have used this medication within||
1483|101|P|the past few months.||
1483|102|P|   Though it is unlikely, this medication may temporarily slow||
1483|103|P|down a child's growth if used for a long time. See the doctor||
1483|104|P|regularly so your child's height can be checked.||
1483|105|P|   During pregnancy, this medication should be used only when||
1483|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
1483|107|P|   It is unknown if this medication passes into breast milk.||
1483|108|P|Consult your doctor before breastfeeding.||
1483|109|B|||
1483|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1483|111|I|medications work or increase your risk for serious side effects.||
1483|112|I|This document does not contain all possible drug interactions.||
1483|113|I|Keep a list of all the products you use (including||
1483|114|I|prescription/nonprescription drugs and herbal products) and share||
1483|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
1483|116|I|the dosage of any medicines without your doctor's approval.||
1483|117|B|||
1483|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1483|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1483|120|O|poison control center right away. US residents can call||
1483|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1483|122|B|||
1483|123|N|NOTES:  Do not share this medication with others.||
1483|124|N|   If you use this medication for a long time, lab and/or medical||
1483|125|N|tests (such as nose exams, height measurement in children) may be||
1483|126|N|done while you are using this medication. Keep all medical and||
1483|127|N|lab appointments. Consult your doctor for more details.||
1483|128|N|   Ask your doctor for ways to reduce your exposure to substances||
1483|129|N|(such as pollen, pet dander, dust mites, mold, smoke) that can||
1483|130|N|worsen allergy symptoms.||
1483|131|B|||
1483|132|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1483|133|D|If it is near the time of the next dose, skip the missed dose.||
1483|134|D|Use your next dose at the regular time. Do not double the dose to||
1483|135|D|catch up.||
1483|136|B|||
1483|137|R|STORAGE:  Store at room temperature. Do not puncture the||
1483|138|R|canister. Do not use, store, or discard it near heat or open||
1483|139|R|flame. Keep all medications away from children and pets.||
1483|140|R|   Do not flush medications down the toilet or pour them into a||
1483|141|R|drain unless instructed to do so. Properly discard this product||
1483|142|R|when it is expired or no longer needed. Consult your pharmacist||
1483|143|R|or local waste disposal company.||
1483|144|B|||
1483|145|A|Information last revised November 2024.||
1483|146|A|Copyright(c) 2025 First Databank, Inc.||
1483|147|B|||
1484|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1484|002|Z|does NOT have all possible information about this product. This||
1484|003|Z|information does not assure that this product is safe, effective,||
1484|004|Z|or appropriate for you. This information is not individual||
1484|005|Z|medical advice and does not substitute for the advice of your||
1484|006|Z|health care professional. Always ask your health care||
1484|007|Z|professional for complete information about this product and your||
1484|008|Z|specific health needs.||
1484|009|B|||
1484|010|T|IPRATROPIUM/ALBUTEROL (SALBUTAMOL) SPRAY - ORAL INHALATION||
1484|011|F|(IP-ra-TROE-pee-um/al-BUE-ter-ol/sal-BUE-ta-mol)||
1484|012|B|||
1484|013|C|COMMON BRAND NAME(S): Combivent Respimat||
1484|014|B|||
1484|015|U|USES:  This product is used to treat and prevent symptoms||
1484|016|U|(wheezing and shortness of breath) caused by ongoing lung disease||
1484|017|U|(chronic obstructive pulmonary disease-COPD, which includes||
1484|018|U|bronchitis and emphysema). This product contains 2 medications:||
1484|019|U|ipratropium and albuterol (also known as salbutamol). Both drugs||
1484|020|U|work by relaxing the muscles around the airways so that the||
1484|021|U|airways open up and you can breathe more easily. Controlling||
1484|022|U|symptoms of breathing problems can decrease time lost from work||
1484|023|U|or school.||
1484|024|B|||
1484|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1484|026|H|from your pharmacist before you start using this product and each||
1484|027|H|time you get a refill. Learn how to use this inhaler properly. If||
1484|028|H|you have any questions, ask your doctor or pharmacist.||
1484|029|H|   Follow the instructions for priming the inhaler if you are||
1484|030|H|using it for the first time or if you have not used it for more||
1484|031|H|than 3 days or for more than 21 days. When priming the inhaler,||
1484|032|H|make sure to spray away from the face so that you do not get the||
1484|033|H|medication into your eyes.||
1484|034|H|   Inhale this medication by mouth as directed by your doctor,||
1484|035|H|usually 4 times daily. Your doctor may also direct you to use||
1484|036|H|this medication as needed for wheezing and shortness of breath.||
1484|037|H|Follow your doctor's instructions carefully. However, the||
1484|038|H|manufacturer recommends that you do not use more than 6||
1484|039|H|inhalations in a 24-hour period. Doing so may increase the risk||
1484|040|H|of serious side effects.||
1484|041|H|   The dosage is based on your medical condition and response to||
1484|042|H|treatment.||
1484|043|H|   Avoid getting this medication into your eyes. It may cause eye||
1484|044|H|pain/irritation, temporary blurred vision, and other vision||
1484|045|H|changes. When using the inhaler, put your lips tightly around the||
1484|046|H|mouthpiece.||
1484|047|H|   Rinse your mouth after using the inhaler to prevent dry mouth||
1484|048|H|and throat irritation.||
1484|049|H|   If you are using other inhalers at the same time, wait at||
1484|050|H|least 1 minute between the use of each medication.||
1484|051|H|   Use this medication regularly to get the most benefit from it.||
1484|052|H|This medication works best if used at evenly spaced intervals. To||
1484|053|H|help you remember, use it at the same times each day. Do not||
1484|054|H|increase your dose, use this medication more often, or stop using||
1484|055|H|it without first consulting your doctor.||
1484|056|H|   Clean the mouthpiece of the inhaler at least once a week as||
1484|057|H|directed.||
1484|058|H|   Learn which of your inhalers you should use every day and||
1484|059|H|which you should use if your breathing suddenly worsens||
1484|060|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1484|061|H|should do if you have new or worsening cough or shortness of||
1484|062|H|breath, wheezing, increased sputum, waking up at night with||
1484|063|H|trouble breathing, if you use your quick-relief inhaler more||
1484|064|H|often, or if your quick-relief inhaler does not seem to be||
1484|065|H|working well. Learn when you can treat sudden breathing problems||
1484|066|H|by yourself and when you must get medical help right away.||
1484|067|H|   Tell your doctor if your symptoms do not get better or if they||
1484|068|H|get worse.||
1484|069|B|||
1484|070|S|SIDE EFFECTS:  See also How to Use section.||
1484|071|S|   Headache, dizziness, cough, nausea, dry mouth, shaking||
1484|072|S|(tremors), nervousness, or constipation may occur. If any of||
1484|073|S|these effects last or get worse, tell your doctor or pharmacist||
1484|074|S|promptly.||
1484|075|S|   Remember that this medication has been prescribed because your||
1484|076|S|doctor has judged that the benefit to you is greater than the||
1484|077|S|risk of side effects. Many people using this medication do not||
1484|078|S|have serious side effects.||
1484|079|S|   This medication may raise your blood pressure. Check your||
1484|080|S|blood pressure regularly and tell your doctor if the results are||
1484|081|S|high.||
1484|082|S|   Rarely, this medication may cause severe sudden worsening of||
1484|083|S|breathing problems right after use. If you have sudden worsening||
1484|084|S|of breathing, get medical help right away.||
1484|085|S|   Tell your doctor right away if you have any serious side||
1484|086|S|effects, including: difficult/painful urination, muscle cramps.||
1484|087|S|   Get medical help right away if you have any very serious side||
1484|088|S|effects, including: chest pain, fast/pounding/irregular||
1484|089|S|heartbeat, rapid breathing, confusion, eye pain/swelling/redness,||
1484|090|S|vision changes (such as seeing rainbows around lights at night,||
1484|091|S|blurred vision).||
1484|092|S|   A very serious allergic reaction to this product is rare.||
1484|093|S|However, get medical help right away if you notice any symptoms||
1484|094|S|of a serious allergic reaction, including: rash, itching/swelling||
1484|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1484|096|S|breathing.||
1484|097|S|   This is not a complete list of possible side effects. If you||
1484|098|S|notice other effects not listed above, contact your doctor or||
1484|099|S|pharmacist.||
1484|100|S|   In the US -||
1484|101|S|   Call your doctor for medical advice about side effects. You||
1484|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1484|103|S|www.fda.gov/medwatch.||
1484|104|S|   In Canada - Call your doctor for medical advice about side||
1484|105|S|effects. You may report side effects to Health Canada at||
1484|106|S|1-866-234-2345.||
1484|107|B|||
1484|108|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1484|109|P|pharmacist if you are allergic to ipratropium or albuterol||
1484|110|P|(salbutamol); or to tiotropium; or to atropine or other||
1484|111|P|belladonna-type drugs; or to levalbuterol; or if you have any||
1484|112|P|other allergies. This product may contain inactive ingredients,||
1484|113|P|which can cause allergic reactions or other problems. Talk to||
1484|114|P|your pharmacist for more details.||
1484|115|P|   Before using this medication, tell your doctor or pharmacist||
1484|116|P|your medical history, especially of: high blood pressure, heart||
1484|117|P|disease (such as chest pain, heart attack, irregular heartbeat),||
1484|118|P|personal or family history of glaucoma (angle-closure type),||
1484|119|P|difficulty urinating (for example, due to enlarged prostate),||
1484|120|P|seizure, overactive thyroid (hyperthyroidism), diabetes.||
1484|121|P|   This drug may make you dizzy or blur your vision or cause||
1484|122|P|vision changes. Alcohol or marijuana (cannabis) can make you more||
1484|123|P|dizzy. Do not drive, use machinery, or do anything that needs||
1484|124|P|alertness or clear vision until you can do it safely. Limit||
1484|125|P|alcoholic beverages. Talk to your doctor if you are using||
1484|126|P|marijuana (cannabis).||
1484|127|P|   Before having surgery, tell your doctor or dentist about all||
1484|128|P|the products you use (including prescription drugs,||
1484|129|P|nonprescription drugs, and herbal products).||
1484|130|P|   Older adults may be more sensitive to the side effects of this||
1484|131|P|drug, especially problems urinating or constipation.||
1484|132|P|   During pregnancy, this medication should be used only when||
1484|133|P|clearly needed. Discuss the risks and benefits with your doctor.||
1484|134|P|   It is unknown if this medication passes into breast milk.||
1484|135|P|Consult your doctor before breastfeeding.||
1484|136|B|||
1484|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1484|138|I|medications work or increase your risk for serious side effects.||
1484|139|I|This document does not contain all possible drug interactions.||
1484|140|I|Keep a list of all the products you use (including||
1484|141|I|prescription/nonprescription drugs and herbal products) and share||
1484|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
1484|143|I|the dosage of any medicines without your doctor's approval.||
1484|144|I|   Albuterol is very similar to levalbuterol. Do not use||
1484|145|I|medications containing levalbuterol while using albuterol.||
1484|146|B|||
1484|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1484|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1484|149|O|poison control center right away. US residents can call||
1484|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1484|151|O|Symptoms of overdose may include: chest pain, fast/irregular||
1484|152|O|heartbeat, seizures.||
1484|153|B|||
1484|154|N|NOTES:  Do not share this medication with others.||
1484|155|N|   Lab and/or medical tests (such as lung function, blood||
1484|156|N|pressure) may be done while you are using this medication. Keep||
1484|157|N|all medical and lab appointments. Consult your doctor for more||
1484|158|N|details.||
1484|159|B|||
1484|160|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1484|161|D|If it is near the time of the next dose, skip the missed dose.||
1484|162|D|Use your next dose at the regular time. Do not double the dose to||
1484|163|D|catch up.||
1484|164|B|||
1484|165|R|STORAGE:  Store at room temperature. Do not freeze. Once the||
1484|166|R|cartridge is put into the inhaler, this medication expires after||
1484|167|R|3 months. Keep all medications away from children and pets.||
1484|168|R|   Do not flush medications down the toilet or pour them into a||
1484|169|R|drain unless instructed to do so. Properly discard this product||
1484|170|R|when it is expired or no longer needed. Consult your pharmacist||
1484|171|R|or local waste disposal company.||
1484|172|B|||
1484|173|M|MEDICAL ALERT:  Your condition can cause complications in a||
1484|174|M|medical emergency. For information about enrolling in MedicAlert,||
1484|175|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1484|176|B|||
1484|177|A|Information last revised March 2025.||
1484|178|A|Copyright(c) 2025 First Databank, Inc.||
1484|179|B|||
1485|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1485|002|Z|does NOT have all possible information about this product. This||
1485|003|Z|information does not assure that this product is safe, effective,||
1485|004|Z|or appropriate for you. This information is not individual||
1485|005|Z|medical advice and does not substitute for the advice of your||
1485|006|Z|health care professional. Always ask your health care||
1485|007|Z|professional for complete information about this product and your||
1485|008|Z|specific health needs.||
1485|009|B|||
1485|010|T|LIDOCAINE OINTMENT - TOPICAL, MUCOUS MEMBRANE||
1485|011|F|(LYE-doe-kane)||
1485|012|B|||
1485|013|U|USES:  Lidocaine is used to temporarily numb and relieve pain||
1485|014|U|from minor burns (including sunburn), skin abrasions, insect||
1485|015|U|bites, and other painful conditions affecting mucous membranes.||
1485|016|U|Some lidocaine products are used to numb the lining of the mouth||
1485|017|U|or throat before certain medical/dental procedures. It is also||
1485|018|U|used to decrease pain while dentures are being fitted and while||
1485|019|U|your gums are adjusting to the dentures. It should not be used||
1485|020|U|long-term to decrease pain from poorly fitting dentures.||
1485|021|U|Lidocaine belongs to a class of drugs called local anesthetics.||
1485|022|U|   This product should not be used to treat teething pain in||
1485|023|U|infants and young children due to an increased risk of serious||
1485|024|U|side effects. Talk to the doctor for more details and for other||
1485|025|U|ways to treat teething pain.||
1485|026|B|||
1485|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1485|028|H|from your pharmacist before you start using lidocaine and each||
1485|029|H|time you get a refill. If you have any questions, ask your doctor||
1485|030|H|or pharmacist.||
1485|031|H|   Before certain medical/dental procedures, this medication is||
1485|032|H|usually applied by a health care professional. If you are||
1485|033|H|applying this medication yourself, use as directed by your||
1485|034|H|dentist or doctor.||
1485|035|H|   Avoid getting this medication in your eyes. Apply a thin||
1485|036|H|layer, using the smallest amount needed to cover the affected||
1485|037|H|area. The dosage is based on your medical condition and response||
1485|038|H|to treatment. Children's dosage is also based on age and weight.||
1485|039|H|   Do not increase your dose or use this drug more often or for||
1485|040|H|longer than prescribed. Your condition will not improve any||
1485|041|H|faster, and your risk of side effects will increase.||
1485|042|H|   If you are using lidocaine ointment to help relieve the pain||
1485|043|H|from new dentures, apply the ointment with clean hands to all the||
1485|044|H|surfaces of the dentures that touch your gums. To lessen the||
1485|045|H|amount of lidocaine that may be swallowed, do not apply the||
1485|046|H|ointment to the chewing surfaces of your dentures. Continue to||
1485|047|H|consult your dentist regularly during the fitting process. Follow||
1485|048|H|your dentist's instructions carefully. Wash your hands after use.||
1485|049|H|   When this medication is used in the mouth or throat, numbness||
1485|050|H|may make swallowing difficult and increase your risk of||
1485|051|H|swallowing the wrong way or choking. Do not chew gum or eat for 1||
1485|052|H|hour after using this product and while your mouth or throat is||
1485|053|H|numb. It is especially important for children to not eat or chew||
1485|054|H|gum for at least 1 hour after using this product. Be careful not||
1485|055|H|to accidentally bite your tongue or mouth.||
1485|056|H|   If you are applying this medication to other mucous membranes||
1485|057|H|or the skin, clean the affected area before use, if possible, and||
1485|058|H|apply with clean hands as directed. For broken or burned skin,||
1485|059|H|you may apply the ointment with a sterile gauze pad. Wash your||
1485|060|H|hands after use unless you are treating an area on the hands.||
1485|061|H|   Lidocaine starts to numb the affected area within 5 minutes||
1485|062|H|after application. If you are using this product before certain||
1485|063|H|procedures, tell your doctor if the area does not feel numb or||
1485|064|H|the numbness does not go away. If you are using this product to||
1485|065|H|relieve pain/discomfort, tell your doctor if your condition lasts||
1485|066|H|or gets worse.||
1485|067|B|||
1485|068|S|SIDE EFFECTS:  Mild stinging or burning may occur. If any of||
1485|069|S|these effects last or get worse, tell your doctor or pharmacist||
1485|070|S|promptly.||
1485|071|S|   Remember that this medication has been prescribed because your||
1485|072|S|doctor has judged that the benefit to you is greater than the||
1485|073|S|risk of side effects. Many people using this medication do not||
1485|074|S|have serious side effects.||
1485|075|S|   This medication may cause very serious side effects if you are||
1485|076|S|using too much of it or are very sensitive to its effects. Stop||
1485|077|S|using this medication and get medical help right away if you have||
1485|078|S|any very serious side effects, including: dizziness, drowsiness,||
1485|079|S|slow/shallow breathing, mental/mood changes (such as confusion,||
1485|080|S|nervousness), shaking, seizures, vision changes (such as||
1485|081|S|double/blurred vision), ringing in the ears, fainting,||
1485|082|S|pale/bluish/gray skin, unusual tiredness, shortness of breath,||
1485|083|S|fast/slow/irregular heartbeat.||
1485|084|S|   A very serious allergic reaction to this drug is rare.||
1485|085|S|However, get medical help right away if you notice any symptoms||
1485|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1485|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1485|088|S|breathing.||
1485|089|S|   This is not a complete list of possible side effects. If you||
1485|090|S|notice other effects not listed above, contact your doctor or||
1485|091|S|pharmacist.||
1485|092|S|   In the US -||
1485|093|S|   Call your doctor for medical advice about side effects. You||
1485|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1485|095|S|www.fda.gov/medwatch.||
1485|096|S|   In Canada - Call your doctor for medical advice about side||
1485|097|S|effects. You may report side effects to Health Canada at||
1485|098|S|1-866-234-2345.||
1485|099|B|||
1485|100|P|PRECAUTIONS:  Before using lidocaine, tell your doctor, dentist,||
1485|101|P|or pharmacist if you are allergic to it; or to other anesthetics||
1485|102|P|(including amide-type anesthetics such as bupivacaine,||
1485|103|P|prilocaine); or if you have any other allergies. This product may||
1485|104|P|contain inactive ingredients, which can cause allergic reactions||
1485|105|P|or other problems. Talk to your pharmacist for more details.||
1485|106|P|   Before using this medication, tell your doctor, dentist, or||
1485|107|P|pharmacist your medical history, especially of:||
1485|108|P|cuts/sores/bleeding in the area where this drug will be applied,||
1485|109|P|severe infection with high fever, heart problems (such as||
1485|110|P|slow/irregular heartbeat, heart block), severe shock, liver||
1485|111|P|disease, kidney disease, a certain blood disorder||
1485|112|P|(methemoglobinemia).||
1485|113|P|   This drug may make you dizzy or drowsy or cause vision||
1485|114|P|problems if you are using too much of it or are very sensitive to||
1485|115|P|its effects. See Side Effects section. Alcohol or marijuana||
1485|116|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1485|117|P|machinery, or do anything that needs alertness or clear vision||
1485|118|P|until you can do it safely. Limit alcoholic beverages. Talk to||
1485|119|P|your doctor if you are using marijuana (cannabis).||
1485|120|P|   Before having surgery, tell your doctor or dentist about all||
1485|121|P|the products you use (including prescription drugs,||
1485|122|P|nonprescription drugs, and herbal products).||
1485|123|P|   Children may be more sensitive to the side effects of this||
1485|124|P|drug.||
1485|125|P|   During pregnancy, this medication should be used only when||
1485|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
1485|127|P|   This medication passes into breast milk, but is unlikely to||
1485|128|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1485|129|B|||
1485|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1485|131|I|medications work or increase your risk for serious side effects.||
1485|132|I|This document does not contain all possible drug interactions.||
1485|133|I|Keep a list of all the products you use (including||
1485|134|I|prescription/nonprescription drugs and herbal products) and share||
1485|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
1485|136|I|the dosage of any medicines without your doctor's approval.||
1485|137|I|   Tell your doctor or pharmacist if you are using other||
1485|138|I|lidocaine products at the same time as this medication because||
1485|139|I|your risk of serious side effects may increase.||
1485|140|B|||
1485|141|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1485|142|O|has overdosed and has serious symptoms such as passing out or||
1485|143|O|trouble breathing, call 911. Otherwise, call a poison control||
1485|144|O|center right away. US residents can call 1-800-222-1222. Canada||
1485|145|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1485|146|O|include: vision/hearing changes, severe dizziness/drowsiness,||
1485|147|O|fainting, loss of consciousness, shaking, seizures,||
1485|148|O|slow/irregular heartbeat, slow/shallow breathing.||
1485|149|B|||
1485|150|N|NOTES:  Do not share this medication with others.||
1485|151|B|||
1485|152|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
1485|153|D|remember. If it is near the time of the next dose, skip the||
1485|154|D|missed dose. Use your next dose at the regular time. Do not||
1485|155|D|double the dose to catch up.||
1485|156|B|||
1485|157|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
1485|158|R|medications away from children and pets.||
1485|159|R|   Do not flush medications down the toilet or pour them into a||
1485|160|R|drain unless instructed to do so. Properly discard this product||
1485|161|R|when it is expired or no longer needed. Consult your pharmacist||
1485|162|R|or local waste disposal company.||
1485|163|B|||
1485|164|A|Information last revised August 2024.||
1485|165|A|Copyright(c) 2025 First Databank, Inc.||
1485|166|B|||
1486|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1486|002|Z|does NOT have all possible information about this product. This||
1486|003|Z|information does not assure that this product is safe, effective,||
1486|004|Z|or appropriate for you. This information is not individual||
1486|005|Z|medical advice and does not substitute for the advice of your||
1486|006|Z|health care professional. Always ask your health care||
1486|007|Z|professional for complete information about this product and your||
1486|008|Z|specific health needs.||
1486|009|B|||
1486|010|T|IVERMECTIN LOTION - TOPICAL||
1486|011|F|(EYE-ver-MEK-tin)||
1486|012|B|||
1486|013|C|COMMON BRAND NAME(S): Sklice||
1486|014|B|||
1486|015|U|USES:  This medication is used to treat head lice, tiny insects||
1486|016|U|that attach to your hair and live on the blood from your scalp.||
1486|017|U|Head lice infestation causes itching and irritation of the scalp.||
1486|018|U|Ivermectin works by paralyzing and killing parasites such as lice||
1486|019|U|and their eggs (nits).||
1486|020|U|   Ivermectin lotion is not recommended for use in children||
1486|021|U|younger than 6 months of age. Too much medication may be absorbed||
1486|022|U|through their skin, leading to an increased risk of side effects.||
1486|023|B|||
1486|024|H|HOW TO USE:  If you are using the over-the-counter product to||
1486|025|H|self-treat, read and follow all directions on the product package||
1486|026|H|before using this medication. If you have any questions, consult||
1486|027|H|your pharmacist. If your doctor has prescribed this medication,||
1486|028|H|use it as directed.||
1486|029|H|   Apply ivermectin lotion only to dry hair and scalp. Use enough||
1486|030|H|lotion (up to 1 tube) to completely coat and cover all of your||
1486|031|H|hair from the roots to the ends and all of your scalp. Leave it||
1486|032|H|on for a full 10 minutes, then rinse off with water. Children||
1486|033|H|should have an adult apply this medication for them. After using||
1486|034|H|this medication, wait 24 hours before applying shampoo to hair||
1486|035|H|and scalp.||
1486|036|H|   Do not use this medication on your eyebrows or eyelashes.||
1486|037|H|Avoid getting this medication in your eyes. If this occurs, flush||
1486|038|H|your eyes with water. Do not swallow this medication. Do not use||
1486|039|H|ivermectin lotion in your mouth, nose, vagina, or other areas of||
1486|040|H|your body. Wash your hands after applying this medication.||
1486|041|H|   This medication is for a single use only. Throw away any||
1486|042|H|unused lotion. You may use a fine-tooth comb or a special||
1486|043|H|lice/nit comb to remove dead lice/nits.||
1486|044|H|   Tell your doctor if your condition lasts or gets worse.||
1486|045|B|||
1486|046|S|SIDE EFFECTS:  Eye redness/irritation, dry skin, or a||
1486|047|S|stinging/burning feeling may occur. If any of these effects last||
1486|048|S|or get worse, tell your doctor or pharmacist promptly.||
1486|049|S|   Remember that this medication has been prescribed because your||
1486|050|S|doctor has judged that the benefit to you is greater than the||
1486|051|S|risk of side effects. Many people using this medication do not||
1486|052|S|have serious side effects.||
1486|053|S|   A very serious allergic reaction to this drug is rare.||
1486|054|S|However, get medical help right away if you notice any symptoms||
1486|055|S|of a serious allergic reaction, including: rash, itching/swelling||
1486|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1486|057|S|breathing.||
1486|058|S|   This is not a complete list of possible side effects. If you||
1486|059|S|notice other effects not listed above, contact your doctor or||
1486|060|S|pharmacist.||
1486|061|S|   In the US -||
1486|062|S|   Call your doctor for medical advice about side effects. You||
1486|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1486|064|S|www.fda.gov/medwatch.||
1486|065|S|   In Canada - Call your doctor for medical advice about side||
1486|066|S|effects. You may report side effects to Health Canada at||
1486|067|S|1-866-234-2345.||
1486|068|B|||
1486|069|P|PRECAUTIONS:  Before using ivermectin, tell your doctor or||
1486|070|P|pharmacist if you are allergic to it; or if you have any other||
1486|071|P|allergies. This product may contain inactive ingredients, which||
1486|072|P|can cause allergic reactions or other problems. Talk to your||
1486|073|P|pharmacist for more details.||
1486|074|P|   Before using this medication, tell your doctor or pharmacist||
1486|075|P|your medical history, especially of: skin conditions.||
1486|076|P|   During pregnancy, this medication should be used only when||
1486|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
1486|078|P|   The form of this medication taken by mouth passes into breast||
1486|079|P|milk in small amounts. It is unknown if this form of ivermectin||
1486|080|P|passes into breast milk. Consult your doctor before||
1486|081|P|breastfeeding.||
1486|082|B|||
1486|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1486|084|I|medications work or increase your risk for serious side effects.||
1486|085|I|This document does not contain all possible drug interactions.||
1486|086|I|Keep a list of all the products you use (including||
1486|087|I|prescription/nonprescription drugs and herbal products) and share||
1486|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
1486|089|I|the dosage of any medicines without your doctor's approval.||
1486|090|B|||
1486|091|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1486|092|O|has overdosed and has serious symptoms such as passing out or||
1486|093|O|trouble breathing, call 911. Otherwise, call a poison control||
1486|094|O|center right away. US residents can call 1-800-222-1222. Canada||
1486|095|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1486|096|O|include: rash, swelling, headache, dizziness, vomiting, diarrhea,||
1486|097|O|numbness/tingling, seizures, loss of coordination, shortness of||
1486|098|O|breath.||
1486|099|B|||
1486|100|N|NOTES:  To prevent the spread of lice, wash in hot water or dry||
1486|101|N|clean all recently used clothing, hats, bedding, and towels. Soak||
1486|102|N|and wash in hot water all hair care items such as brushes, combs,||
1486|103|N|and hair clips.||
1486|104|B|||
1486|105|D|MISSED DOSE:  Not applicable.||
1486|106|B|||
1486|107|R|STORAGE:  Store at room temperature. Do not freeze. This||
1486|108|R|medication is for single use only. Throw away any unused lotion.||
1486|109|R|Keep all medications away from children and pets.||
1486|110|R|   Do not flush medications down the toilet or pour them into a||
1486|111|R|drain unless instructed to do so. Properly discard this product||
1486|112|R|when it is expired or no longer needed. Consult your pharmacist||
1486|113|R|or local waste disposal company.||
1486|114|B|||
1486|115|A|Information last revised May 2024.||
1486|116|A|Copyright(c) 2025 First Databank, Inc.||
1486|117|B|||
1487|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1487|002|Z|does NOT have all possible information about this product. This||
1487|003|Z|information does not assure that this product is safe, effective,||
1487|004|Z|or appropriate for you. This information is not individual||
1487|005|Z|medical advice and does not substitute for the advice of your||
1487|006|Z|health care professional. Always ask your health care||
1487|007|Z|professional for complete information about this product and your||
1487|008|Z|specific health needs.||
1487|009|B|||
1487|010|T|PHENTERMINE/TOPIRAMATE EXTENDED-RELEASE CAPSULE - ORAL||
1487|011|F|(FEN-ter-meen/toe-PYRE-a-mate)||
1487|012|B|||
1487|013|C|COMMON BRAND NAME(S): Qsymia||
1487|014|B|||
1487|015|W|WARNING:  To receive phentermine/topiramate in the United States,||
1487|016|W|you must understand, agree to, and carefully follow the||
1487|017|W|requirements of the REMS Program for this medication. If you live||
1487|018|W|in Canada or any other country, consult your doctor and||
1487|019|W|pharmacist for your country's regulations.||
1487|020|B|||
1487|021|U|USES:  This medication is used with a doctor-approved exercise,||
1487|022|U|behavior change, and reduced-calorie diet program to help you||
1487|023|U|lose weight. It is used in adults and children 12 years or older||
1487|024|U|who are obese. It is also used in certain overweight people, such||
1487|025|U|as those who have weight-related medical problems. Losing weight||
1487|026|U|and keeping it off can lessen the many health risks that come||
1487|027|U|with obesity, including heart disease, diabetes, high blood||
1487|028|U|pressure, and a shorter life.||
1487|029|U|   It is not known how this medication helps people to lose||
1487|030|U|weight. It may work by decreasing your appetite, by increasing||
1487|031|U|the amount of energy used by your body, or by affecting certain||
1487|032|U|parts of the brain. This medication is a combination of||
1487|033|U|phentermine and topiramate. Phentermine is an appetite||
1487|034|U|suppressant and belongs to a class of drugs called||
1487|035|U|sympathomimetic amines. Topiramate is known as an anticonvulsant||
1487|036|U|or antiepileptic drug.||
1487|037|B|||
1487|038|H|HOW TO USE:  Read the Medication Guide provided by your||
1487|039|H|pharmacist before you start taking this medication and each time||
1487|040|H|you get a refill. If you have any questions, ask your doctor or||
1487|041|H|pharmacist.||
1487|042|H|   Take this medication by mouth with or without food as directed||
1487|043|H|by your doctor, usually once daily in the morning. Taking this||
1487|044|H|medication late in the day may cause trouble sleeping (insomnia).||
1487|045|H|Swallow the capsules whole. Do not crush or chew the capsules.||
1487|046|H|Doing so can release all of the drug at once, increasing the risk||
1487|047|H|of side effects.||
1487|048|H|   The dosage is based on your medical condition and response to||
1487|049|H|treatment. To reduce your risk of side effects, your doctor may||
1487|050|H|direct you to start this medication at a low dose and gradually||
1487|051|H|increase your dose. Follow your doctor's instructions carefully.||
1487|052|H|   To prevent kidney stones from forming, drink plenty of liquids||
1487|053|H|while taking this medication unless your doctor instructs you||
1487|054|H|otherwise.||
1487|055|H|   Caffeine can increase the side effects of this medication.||
1487|056|H|Avoid drinking large amounts of beverages containing caffeine||
1487|057|H|(coffee, tea, colas), eating large amounts of chocolate, or||
1487|058|H|taking nonprescription products that contain caffeine.||
1487|059|H|   If you suddenly stop using this medication, you may have||
1487|060|H|withdrawal symptoms (such as seizures). To help prevent||
1487|061|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1487|062|H|more likely if you have used this medication for a long time or||
1487|063|H|in high doses. Tell your doctor or pharmacist right away if you||
1487|064|H|have withdrawal.||
1487|065|H|   Though it helps many people, this medication may sometimes||
1487|066|H|cause addiction. This risk may be higher if you have a substance||
1487|067|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1487|068|H|Do not increase your dose, take it more often, or use it for a||
1487|069|H|longer time than prescribed. Your condition will not improve any||
1487|070|H|faster, and your risk of side effects will increase. Take this||
1487|071|H|medication exactly as prescribed to lower the risk of addiction.||
1487|072|H|   Since this drug can be absorbed through the skin and lungs and||
1487|073|H|may harm an unborn baby, women who are pregnant or who may become||
1487|074|H|pregnant should not handle this medication.||
1487|075|H|   When this medication is used for several weeks, it may not||
1487|076|H|work as well. Talk with your doctor if this medication stops||
1487|077|H|working well. Your doctor may direct you to stop taking this||
1487|078|H|medication.||
1487|079|B|||
1487|080|S|SIDE EFFECTS:  Dizziness, drowsiness, dry mouth, difficulty||
1487|081|S|sleeping, tiredness, tingling of the hands/feet, joint pain,||
1487|082|S|constipation, or metallic taste may occur. If any of these||
1487|083|S|effects last or get worse, tell your doctor or pharmacist||
1487|084|S|promptly.||
1487|085|S|   Remember that this medication has been prescribed because your||
1487|086|S|doctor has judged that the benefit to you is greater than the||
1487|087|S|risk of side effects. Many people using this medication do not||
1487|088|S|have serious side effects.||
1487|089|S|   This medication may raise your blood pressure. Check your||
1487|090|S|blood pressure regularly and tell your doctor if the results are||
1487|091|S|high.||
1487|092|S|   Tell your doctor right away if you have any serious side||
1487|093|S|effects, including: signs of kidney stones (such as painful||
1487|094|S|urination, fever, chills, pink/bloody urine), bone pain, change||
1487|095|S|in sexual ability/interest, unusual bleeding/bruising, confusion,||
1487|096|S|difficulty concentrating, memory loss.||
1487|097|S|   A small number of people who take anticonvulsants for any||
1487|098|S|reason (such as seizure, bipolar disorder, pain) may experience||
1487|099|S|depression, suicidal thoughts/attempts, or other mental/mood||
1487|100|S|problems. Tell your doctor right away if you or your||
1487|101|S|family/caregiver notice any unusual/sudden changes in your mood,||
1487|102|S|thoughts, or behavior including signs of depression, suicidal||
1487|103|S|thoughts/attempts, thoughts about harming yourself.||
1487|104|S|   Rarely, topiramate may cause a very serious eye problem,||
1487|105|S|usually within 1 month of starting treatment. This eye problem||
1487|106|S|can lead to permanent blindness. Get medical help right away if||
1487|107|S|any of these side effects occur: sudden vision changes (such as||
1487|108|S|decreased vision, blurred vision), eye pain/redness.||
1487|109|S|   This medication can rarely cause a serious metabolic problem||
1487|110|S|(high amount of ammonia in the blood), especially if you are also||
1487|111|S|taking valproic acid. Tell your doctor right away if you||
1487|112|S|experience sudden/unexplained tiredness, vomiting, or mental||
1487|113|S|changes (such as decreased alertness).||
1487|114|S|   Get medical help right away if you have any very serious side||
1487|115|S|effects, including: rapid breathing, fast/slow/irregular||
1487|116|S|heartbeat, severe headache, trouble speaking, seizure, weakness||
1487|117|S|on one side of the body.||
1487|118|S|   This drug may rarely cause serious (sometimes fatal) lung or||
1487|119|S|heart problems (pulmonary hypertension, heart valve problems).||
1487|120|S|The risk may increase with longer use of this medication and use||
1487|121|S|of other appetite-suppressant drugs/herbal products along with||
1487|122|S|this drug. Stop taking this medication and get medical help right||
1487|123|S|away if you have any very serious side effects, including: chest||
1487|124|S|pain, difficulty breathing with exercise/decreased ability to||
1487|125|S|exercise, fainting, swelling of the legs/ankles/feet.||
1487|126|S|   A very serious allergic reaction to this drug is rare.||
1487|127|S|However, get medical help right away if you notice any symptoms||
1487|128|S|of a serious allergic reaction, including: rash, itching/swelling||
1487|129|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1487|130|S|breathing.||
1487|131|S|   This is not a complete list of possible side effects. If you||
1487|132|S|notice other effects not listed above, contact your doctor or||
1487|133|S|pharmacist.||
1487|134|S|   In the US -||
1487|135|S|   Call your doctor for medical advice about side effects. You||
1487|136|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1487|137|S|www.fda.gov/medwatch.||
1487|138|S|   In Canada - Call your doctor for medical advice about side||
1487|139|S|effects. You may report side effects to Health Canada at||
1487|140|S|1-866-234-2345.||
1487|141|B|||
1487|142|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1487|143|P|pharmacist if you are allergic to it; or to any other||
1487|144|P|sympathomimetic amines (including decongestants such as||
1487|145|P|pseudoephedrine, stimulants such as amphetamine, appetite||
1487|146|P|suppressants such as diethylpropion); or if you have any other||
1487|147|P|allergies. This product may contain inactive ingredients (such as||
1487|148|P|tartrazine), which can cause allergic reactions or other||
1487|149|P|problems. Talk to your pharmacist for more details.||
1487|150|P|   Before using this medication, tell your doctor or pharmacist||
1487|151|P|your medical history, especially of: high blood pressure,||
1487|152|P|glaucoma, personal or family history of a substance use disorder||
1487|153|P|(such as overuse of or addiction to drugs/alcohol), heart disease||
1487|154|P|(such as chest pain, heart attack, heart murmur, fast/irregular||
1487|155|P|heartbeat, heart valve problems), mental/mood problems (such as||
1487|156|P|depression, thoughts of suicide, severe anxiety/agitation), high||
1487|157|P|blood pressure in the lungs (pulmonary hypertension), stroke,||
1487|158|P|overactive thyroid (hyperthyroidism), seizures, kidney disease||
1487|159|P|(including kidney stones), liver disease, a certain metabolic||
1487|160|P|imbalance (metabolic acidosis), a diet high in fat and low in||
1487|161|P|carbohydrates (ketogenic diet).||
1487|162|P|   This drug may make you dizzy or drowsy or blur your vision.||
1487|163|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1487|164|P|drowsy. Do not drive, use machinery, or do anything that needs||
1487|165|P|alertness or clear vision until you can do it safely. Avoid||
1487|166|P|alcoholic beverages. Talk to your doctor if you are using||
1487|167|P|marijuana (cannabis).||
1487|168|P|   This medication may make you sweat less, making you more||
1487|169|P|likely to get heat stroke. Avoid doing things that may cause you||
1487|170|P|to overheat, such as hard work or exercise in hot weather, or||
1487|171|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1487|172|P|and dress lightly. If you overheat, quickly look for a place to||
1487|173|P|cool down and rest. Get medical help right away if you have a||
1487|174|P|fever that does not go away, mental/mood changes, headache, or||
1487|175|P|dizziness.||
1487|176|P|   If you have diabetes, check your blood sugar regularly as||
1487|177|P|directed and share the results with your doctor. Your doctor may||
1487|178|P|need to adjust your diabetes medication during treatment with||
1487|179|P|this medication.||
1487|180|P|   Before having surgery, tell your doctor or dentist about all||
1487|181|P|the products you use (including prescription drugs,||
1487|182|P|nonprescription drugs, and herbal products).||
1487|183|P|   Older adults may be more sensitive to the side effects of this||
1487|184|P|drug, especially dizziness and high blood pressure. Dizziness can||
1487|185|P|increase the risk of falling.||
1487|186|P|   Children may be more sensitive to the side effects of this||
1487|187|P|drug, especially weakened bones, slowed growth rate, and||
1487|188|P|decreased sweating. Consult your doctor or pharmacist for more||
1487|189|P|details.||
1487|190|P|   This medication must not be used during pregnancy. It may harm||
1487|191|P|an unborn baby. Discuss the use of reliable forms of birth||
1487|192|P|control with your doctor. If you become pregnant or think you may||
1487|193|P|be pregnant, tell your doctor right away. You will need to have a||
1487|194|P|negative pregnancy test before starting this medication. You will||
1487|195|P|also need to take a pregnancy test every month while on this||
1487|196|P|medication.||
1487|197|P|   Since this drug can be absorbed through the skin and lungs and||
1487|198|P|may harm an unborn baby, women who are pregnant or who may become||
1487|199|P|pregnant should not handle this medication.||
1487|200|P|   Topiramate passes into breast milk. It is unknown if||
1487|201|P|phentermine passes into breast milk. However, similar drugs pass||
1487|202|P|into breast milk. This medication may have undesirable effects on||
1487|203|P|a nursing infant. Breastfeeding is not recommended while using||
1487|204|P|this medication. Consult your doctor before breastfeeding.||
1487|205|B|||
1487|206|I|DRUG INTERACTIONS:  See also How to Use section.||
1487|207|I|   Drug interactions may change how your medications work or||
1487|208|I|increase your risk for serious side effects. This document does||
1487|209|I|not contain all possible drug interactions. Keep a list of all||
1487|210|I|the products you use (including prescription/nonprescription||
1487|211|I|drugs and herbal products) and share it with your doctor and||
1487|212|I|pharmacist. Do not start, stop, or change the dosage of any||
1487|213|I|medicines without your doctor's approval.||
1487|214|I|   Taking MAO inhibitors with this medication may cause a serious||
1487|215|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1487|216|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1487|217|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1487|218|I|selegiline, tranylcypromine) during treatment with this||
1487|219|I|medication. Most MAO inhibitors should also not be taken for two||
1487|220|I|weeks before treatment with this medication. Ask your doctor when||
1487|221|I|to start or stop taking this medication.||
1487|222|I|   This drug should not be used with certain medications because||
1487|223|I|very serious interactions may occur. If you are taking or have||
1487|224|I|taken other appetite-suppressant drugs in the past year (such as||
1487|225|I|diethylpropion, ephedra/ma huang), tell your doctor or pharmacist||
1487|226|I|before starting this medication.||
1487|227|I|   Some products that may interact with this drug include:||
1487|228|I|orlistat, other stimulants (including amphetamines,||
1487|229|I|methylphenidate, street drugs such as cocaine or MDMA/"ecstasy").||
1487|230|I|   Tell your doctor or pharmacist if you are taking other||
1487|231|I|products that cause drowsiness including alcohol, marijuana||
1487|232|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1487|233|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1487|234|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1487|235|I|codeine).||
1487|236|I|   Some products have ingredients that could raise your heart||
1487|237|I|rate or blood pressure. Tell your pharmacist what products you||
1487|238|I|are using, and ask how to use them safely (especially||
1487|239|I|cough-and-cold products or diet aids).||
1487|240|I|   If you are taking hormonal birth control (such as pills,||
1487|241|I|patch, or ring) with this medication, tell your doctor if you||
1487|242|I|have any new spotting or breakthrough bleeding.||
1487|243|I|   This medication may interfere with certain medical/lab tests||
1487|244|I|(such as brain scan for Parkinson's disease), possibly causing||
1487|245|I|false test results. Make sure lab personnel and all your doctors||
1487|246|I|know you use this drug.||
1487|247|B|||
1487|248|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1487|249|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1487|250|O|poison control center right away. US residents can call||
1487|251|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1487|252|O|Symptoms of overdose may include: rapid breathing, unusual||
1487|253|O|restlessness, fast/slow/irregular heartbeat, chest pain,||
1487|254|O|hallucinations, seizures, loss of consciousness, severe||
1487|255|O|drowsiness.||
1487|256|B|||
1487|257|N|NOTES:  Do not share this medication with others. Sharing it is||
1487|258|N|against the law.||
1487|259|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
1487|260|N|heart tests, eye exams, kidney function, blood sugar, potassium||
1487|261|N|and bicarbonate blood levels) should be done before you start||
1487|262|N|taking this medication and while you are taking it. Keep all||
1487|263|N|medical and lab appointments. Consult your doctor for more||
1487|264|N|details.||
1487|265|B|||
1487|266|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1487|267|D|next dose at the regular time. Do not double the dose to catch||
1487|268|D|up.||
1487|269|B|||
1487|270|R|STORAGE:  Store at room temperature away from light and moisture.||
1487|271|R|Do not store in the bathroom. Keep all medications away from||
1487|272|R|children and pets.||
1487|273|R|   Do not flush medications down the toilet or pour them into a||
1487|274|R|drain unless instructed to do so. Properly discard this product||
1487|275|R|when it is expired or no longer needed. Consult your pharmacist||
1487|276|R|or local waste disposal company.||
1487|277|B|||
1487|278|A|Information last revised July 2025.||
1487|279|A|Copyright(c) 2025 First Databank, Inc.||
1487|280|B|||
1488|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1488|002|Z|does NOT have all possible information about this product. This||
1488|003|Z|information does not assure that this product is safe, effective,||
1488|004|Z|or appropriate for you. This information is not individual||
1488|005|Z|medical advice and does not substitute for the advice of your||
1488|006|Z|health care professional. Always ask your health care||
1488|007|Z|professional for complete information about this product and your||
1488|008|Z|specific health needs.||
1488|009|B|||
1488|010|T|CARFILZOMIB - INJECTION||
1488|011|F|(kar-FILZ-oh-mib)||
1488|012|B|||
1488|013|C|COMMON BRAND NAME(S): Kyprolis||
1488|014|B|||
1488|015|U|USES:  This medication is used to treat a certain type of cancer||
1488|016|U|(multiple myeloma). It works by helping to slow the growth and||
1488|017|U|spread of cancer cells.||
1488|018|B|||
1488|019|H|HOW TO USE:  This medication is given by injection into a vein by||
1488|020|H|a health care professional. It is given as directed by your||
1488|021|H|doctor, usually over 10 minutes or over 30 minutes. The dosage is||
1488|022|H|based on your body size, lab tests, medical condition, and||
1488|023|H|response to treatment.||
1488|024|H|   Infusion reactions may happen during the infusion of this drug||
1488|025|H|and for up to 24 hours afterward. Your doctor may prescribe other||
1488|026|H|medications (such as dexamethasone) before each treatment to help||
1488|027|H|prevent these side effects. Tell your doctor right away if you||
1488|028|H|have any symptoms of infusion reactions such as chills, fever,||
1488|029|H|flushing, shortness of breath, joint/muscle pain, chest pain, or||
1488|030|H|fainting.||
1488|031|B|||
1488|032|S|SIDE EFFECTS:  See also How to Use section.||
1488|033|S|   Dizziness, lightheadedness, nausea, vomiting, diarrhea,||
1488|034|S|constipation, and tiredness may occur. If any of these effects||
1488|035|S|last or get worse, tell your doctor or pharmacist promptly.||
1488|036|S|   To reduce the risk of dizziness and lightheadedness, get up||
1488|037|S|slowly when rising from a sitting or lying position.||
1488|038|S|   People using this medication may have serious side effects.||
1488|039|S|However, you have been prescribed this drug because your doctor||
1488|040|S|has judged that the benefit to you is greater than the risk of||
1488|041|S|side effects. Careful monitoring by your doctor may decrease your||
1488|042|S|risk.||
1488|043|S|   Tell your doctor right away if you have any serious side||
1488|044|S|effects, including: headache that is severe or doesn't go away,||
1488|045|S|easy bruising/bleeding, numbness/tingling of arms/legs, fainting,||
1488|046|S|fast/irregular heartbeat, symptoms of heart failure (such as||
1488|047|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
1488|048|S|unusual/sudden weight gain), signs of liver disease (such as||
1488|049|S|nausea/vomiting that doesn't stop, loss of appetite,||
1488|050|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1488|051|S|mental/mood changes (such as confusion).||
1488|052|S|   This medication may raise your blood pressure. Check your||
1488|053|S|blood pressure regularly and tell your doctor if the results are||
1488|054|S|high. Your doctor may control your blood pressure with||
1488|055|S|medication.||
1488|056|S|   Carfilzomib sometimes causes side effects due to the rapid||
1488|057|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1488|058|S|risk, your doctor may add a medication and tell you to drink||
1488|059|S|plenty of fluids. Tell your doctor right away if you have||
1488|060|S|symptoms such as: low back/side pain (flank pain), signs of||
1488|061|S|kidney problems (such as painful urination, pink/bloody urine,||
1488|062|S|change in the amount of urine), muscle spasms/weakness.||
1488|063|S|   This medication may increase your risk of getting a rare but||
1488|064|S|very serious (possibly fatal) brain infection (progressive||
1488|065|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1488|066|S|if you have any of these side effects: clumsiness, loss of||
1488|067|S|coordination/balance, weakness, sudden change in your thinking||
1488|068|S|(such as confusion, difficulty concentrating, memory loss),||
1488|069|S|difficulty talking/walking, seizure, vision changes.||
1488|070|S|   Get medical help right away if you have any very serious side||
1488|071|S|effects, including: sudden pain/swelling/redness in the legs,||
1488|072|S|chest/jaw/left arm pain, trouble breathing, weakness on one side||
1488|073|S|of the body, trouble speaking, black/bloody stools, vomit that||
1488|074|S|looks like coffee grounds.||
1488|075|S|   This medication may lower your ability to fight infections.||
1488|076|S|This may make you more likely to get a serious (rarely fatal)||
1488|077|S|infection or make any infection you have worse. Tell your doctor||
1488|078|S|right away if you have any signs of infection (such as sore||
1488|079|S|throat that doesn't go away, fever, chills).||
1488|080|S|   A very serious allergic reaction to this drug is rare.||
1488|081|S|However, get medical help right away if you notice any symptoms||
1488|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1488|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1488|084|S|breathing.||
1488|085|S|   This is not a complete list of possible side effects. If you||
1488|086|S|notice other effects not listed above, contact your doctor or||
1488|087|S|pharmacist.||
1488|088|S|   In the US -||
1488|089|S|   Call your doctor for medical advice about side effects. You||
1488|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1488|091|S|www.fda.gov/medwatch.||
1488|092|S|   In Canada - Call your doctor for medical advice about side||
1488|093|S|effects. You may report side effects to Health Canada at||
1488|094|S|1-866-234-2345.||
1488|095|B|||
1488|096|P|PRECAUTIONS:  Before taking carfilzomib, tell your doctor or||
1488|097|P|pharmacist if you are allergic to it; or if you have any other||
1488|098|P|allergies. This product may contain inactive ingredients, which||
1488|099|P|can cause allergic reactions or other problems. Talk to your||
1488|100|P|pharmacist for more details.||
1488|101|P|   Before using this medication, tell your doctor or pharmacist||
1488|102|P|your medical history, especially of: heart disease (such as heart||
1488|103|P|failure, heart attack, heart rhythm problems), high blood||
1488|104|P|pressure, kidney disease, liver disease (such as hepatitis B),||
1488|105|P|certain viral infections (herpes, shingles).||
1488|106|P|   Carfilzomib can make you more likely to get infections or may||
1488|107|P|make current infections worse. Stay away from anyone who has an||
1488|108|P|infection that may easily spread (such as chickenpox, COVID-19,||
1488|109|P|measles, flu). Talk to your doctor if you have been exposed to an||
1488|110|P|infection or for more details.||
1488|111|P|   Tell your health care professional that you are using||
1488|112|P|carfilzomib before having any immunizations/vaccinations. Avoid||
1488|113|P|contact with people who have recently received live vaccines||
1488|114|P|(such as flu vaccine inhaled through the nose).||
1488|115|P|   To lower the chance of getting cut, bruised, or injured, use||
1488|116|P|caution with sharp objects like razors and nail cutters, and||
1488|117|P|avoid activities such as contact sports.||
1488|118|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1488|119|P|can make you more dizzy. Do not drive, use machinery, or do||
1488|120|P|anything that needs alertness until you can do it safely. Limit||
1488|121|P|alcoholic beverages. Talk to your doctor if you are using||
1488|122|P|marijuana (cannabis).||
1488|123|P|   Before having surgery, tell your doctor or dentist about all||
1488|124|P|the products you use (including prescription drugs,||
1488|125|P|nonprescription drugs, and herbal products).||
1488|126|P|   Older adults may be more sensitive to the side effects of this||
1488|127|P|drug, especially heart problems.||
1488|128|P|   Tell your doctor if you are pregnant or plan to become||
1488|129|P|pregnant. You should not become pregnant while using carfilzomib.||
1488|130|P|Carfilzomib may harm an unborn baby. Your doctor should order a||
1488|131|P|pregnancy test before you start this medication. Women using this||
1488|132|P|medication should ask about reliable forms of birth control||
1488|133|P|during treatment and for 6 months after the last dose. Men using||
1488|134|P|this medication should ask about reliable forms of birth control||
1488|135|P|during treatment and for 3 months after the last dose. If you or||
1488|136|P|your partner becomes pregnant, talk to your doctor right away||
1488|137|P|about the risks and benefits of this medication.||
1488|138|P|   It is unknown if this drug passes into breast milk. Because of||
1488|139|P|the possible risk to the infant, breastfeeding is not recommended||
1488|140|P|while using this drug and for 2 weeks after the last dose.||
1488|141|P|Consult your doctor before breastfeeding.||
1488|142|B|||
1488|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1488|144|I|medications work or increase your risk for serious side effects.||
1488|145|I|This document does not contain all possible drug interactions.||
1488|146|I|Keep a list of all the products you use (including||
1488|147|I|prescription/nonprescription drugs and herbal products) and share||
1488|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
1488|149|I|the dosage of any medicines without your doctor's approval.||
1488|150|I|   Some products that may interact with this drug are: other||
1488|151|I|drugs that weaken the immune system/increase the risk of||
1488|152|I|infection (such as natalizumab, rituximab).||
1488|153|B|||
1488|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1488|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1488|156|O|poison control center right away. US residents can call||
1488|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1488|158|B|||
1488|159|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
1488|160|N|blood potassium level, blood pressure, complete blood count||
1488|161|N|including platelets) should be done while you are using this||
1488|162|N|medication. Keep all medical and lab appointments.||
1488|163|B|||
1488|164|D|MISSED DOSE:  It is important to get each dose of this medication||
1488|165|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1488|166|D|right away for a new dosing schedule.||
1488|167|B|||
1488|168|R|STORAGE:  Not applicable. This medication is given in a clinic||
1488|169|R|and will not be stored at home.||
1488|170|B|||
1488|171|M|MEDICAL ALERT:  Your condition can cause complications in a||
1488|172|M|medical emergency. For information about enrolling in MedicAlert,||
1488|173|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1488|174|B|||
1488|175|A|Information last revised April 2025.||
1488|176|A|Copyright(c) 2025 First Databank, Inc.||
1488|177|B|||
1489|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1489|002|Z|does NOT have all possible information about this product. This||
1489|003|Z|information does not assure that this product is safe, effective,||
1489|004|Z|or appropriate for you. This information is not individual||
1489|005|Z|medical advice and does not substitute for the advice of your||
1489|006|Z|health care professional. Always ask your health care||
1489|007|Z|professional for complete information about this product and your||
1489|008|Z|specific health needs.||
1489|009|B|||
1489|010|T|DOXERCALCIFEROL - INJECTION||
1489|011|F|(DOX-er-kal-SIF-er-ol)||
1489|012|B|||
1489|013|C|COMMON BRAND NAME(S): Hectorol||
1489|014|B|||
1489|015|U|USES:  This medication is used to treat people with serious||
1489|016|U|kidney disease on dialysis who have high levels of a certain||
1489|017|U|substance (parathyroid hormone-PTH), which your body normally||
1489|018|U|makes. High PTH levels affect the balance of other minerals in||
1489|019|U|your body (calcium and phosphorus) and may cause weak bones.||
1489|020|U|Doxercalciferol is a form of vitamin D. It works by decreasing||
1489|021|U|PTH levels and increasing calcium/phosphorus levels in the body.||
1489|022|B|||
1489|023|H|HOW TO USE:  This medication is given by injection into a vein as||
1489|024|H|directed by your doctor, usually 3 times a week (such as Monday,||
1489|025|H|Wednesday, Friday) at the end of dialysis. The dosage is based on||
1489|026|H|your medical condition, lab tests, and response to treatment.||
1489|027|H|Your doctor may adjust your dose or temporarily stop this drug||
1489|028|H|based on lab test results (such as PTH, calcium, and phosphorus||
1489|029|H|levels).||
1489|030|H|   If you are using this medication at home, learn all||
1489|031|H|preparation and usage instructions from your health care||
1489|032|H|professional and the product package. Before using, check this||
1489|033|H|product for particles or discoloration. If either is present, do||
1489|034|H|not use the liquid. Learn how to store and discard medical||
1489|035|H|supplies safely.||
1489|036|H|   It is very important to follow the diet recommended by your||
1489|037|H|doctor to get the most benefit from this medication and to||
1489|038|H|prevent serious side effects. Do not take more than 2 grams of||
1489|039|H|calcium a day while you are taking this medication. Sources of||
1489|040|H|calcium include your diet, phosphate binders, or calcium||
1489|041|H|supplements. If you have any questions about how much calcium you||
1489|042|H|take in a day, ask your doctor or pharmacist. Do not take other||
1489|043|H|supplements/vitamins (such as vitamin D) unless otherwise||
1489|044|H|directed by your doctor. (See also Drug Interactions section.)||
1489|045|B|||
1489|046|S|SIDE EFFECTS:  Headache, upset stomach, constipation, nausea,||
1489|047|S|vomiting, and tiredness may occur. If any of these effects last||
1489|048|S|or get worse, tell your doctor or pharmacist promptly.||
1489|049|S|   Remember that this medication has been prescribed because your||
1489|050|S|doctor has judged that the benefit to you is greater than the||
1489|051|S|risk of side effects. Many people using this medication do not||
1489|052|S|have serious side effects.||
1489|053|S|   Tell your doctor right away if you have any serious side||
1489|054|S|effects, including: bone/joint/muscle pain, loss of appetite,||
1489|055|S|increased thirst, increased urination, fast/slow/irregular||
1489|056|S|heartbeat, mental/mood changes (such as drowsiness,||
1489|057|S|disturbed/irrational thoughts or beliefs), metallic taste in||
1489|058|S|mouth, weakness, unexplained weight gain or loss.||
1489|059|S|   A very serious allergic reaction to this drug is rare.||
1489|060|S|However, get medical help right away if you notice any symptoms||
1489|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1489|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1489|063|S|breathing.||
1489|064|S|   This is not a complete list of possible side effects. If you||
1489|065|S|notice other effects not listed above, contact your doctor or||
1489|066|S|pharmacist.||
1489|067|S|   In the US -||
1489|068|S|   Call your doctor for medical advice about side effects. You||
1489|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1489|070|S|www.fda.gov/medwatch.||
1489|071|S|   In Canada - Call your doctor for medical advice about side||
1489|072|S|effects. You may report side effects to Health Canada at||
1489|073|S|1-866-234-2345.||
1489|074|B|||
1489|075|P|PRECAUTIONS:  Before taking doxercalciferol, tell your doctor or||
1489|076|P|pharmacist if you are allergic to it; or if you have any other||
1489|077|P|allergies. This product may contain inactive ingredients, which||
1489|078|P|can cause allergic reactions or other problems. Talk to your||
1489|079|P|pharmacist for more details.||
1489|080|P|   Before using this medication, tell your doctor or pharmacist||
1489|081|P|your medical history, especially of: heart problems (such as||
1489|082|P|irregular heartbeat), high calcium blood levels (hypercalcemia),||
1489|083|P|high phosphate blood levels (hyperphosphatemia), liver disease.||
1489|084|P|   Before having surgery, tell your doctor or dentist about all||
1489|085|P|the products you use (including prescription drugs,||
1489|086|P|nonprescription drugs, and herbal products).||
1489|087|P|   During pregnancy, this medication should be used only when||
1489|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
1489|089|P|   It is unknown if this medication passes into breast milk.||
1489|090|P|However, similar drugs pass into breast milk. Consult your doctor||
1489|091|P|before breastfeeding.||
1489|092|B|||
1489|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1489|094|I|medications work or increase your risk for serious side effects.||
1489|095|I|This document does not contain all possible drug interactions.||
1489|096|I|Keep a list of all the products you use (including||
1489|097|I|prescription/nonprescription drugs and herbal products) and share||
1489|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
1489|099|I|the dosage of any medicines without your doctor's approval.||
1489|100|I|   A product that may interact with this drug is: burosumab.||
1489|101|I|   Check the labels on all your medicines (such as antacids,||
1489|102|I|laxatives, vitamins/nutritional supplements) because they may||
1489|103|I|contain calcium, magnesium, phosphate, or vitamin D. Ask your||
1489|104|I|pharmacist about using those products safely.||
1489|105|B|||
1489|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1489|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1489|108|O|poison control center right away. US residents can call||
1489|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1489|110|O|Symptoms of overdose may include: metallic taste in the mouth,||
1489|111|O|irregular heartbeat, severe mental/mood changes, seizures.||
1489|112|B|||
1489|113|N|NOTES:  Do not share this medication with others.||
1489|114|N|   Lab and/or medical tests (such as PTH levels,||
1489|115|N|calcium/magnesium/phosphorus levels, alkaline phosphatase level)||
1489|116|N|should be done before you start using this medication and while||
1489|117|N|you are using it. Keep all medical and lab appointments. Consult||
1489|118|N|your doctor for more details.||
1489|119|N|   Remember that it is best to get your vitamins and minerals||
1489|120|N|from food whenever possible. Maintain a well-balanced diet, and||
1489|121|N|follow any dietary guidelines as directed by your doctor.||
1489|122|B|||
1489|123|D|MISSED DOSE:  It is important to get each dose of this medication||
1489|124|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1489|125|D|right away for a new dosing schedule. Do not double the dose to||
1489|126|D|catch up.||
1489|127|B|||
1489|128|R|STORAGE:  Store at room temperature away from light. Keep all||
1489|129|R|medications away from children and pets.||
1489|130|R|   Do not flush medications down the toilet or pour them into a||
1489|131|R|drain unless instructed to do so. Properly discard this product||
1489|132|R|when it is expired or no longer needed. Consult your pharmacist||
1489|133|R|or local waste disposal company.||
1489|134|B|||
1489|135|A|Information last revised December 2024.||
1489|136|A|Copyright(c) 2025 First Databank, Inc.||
1489|137|B|||
1490|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1490|002|Z|does NOT have all possible information about this product. This||
1490|003|Z|information does not assure that this product is safe, effective,||
1490|004|Z|or appropriate for you. This information is not individual||
1490|005|Z|medical advice and does not substitute for the advice of your||
1490|006|Z|health care professional. Always ask your health care||
1490|007|Z|professional for complete information about this product and your||
1490|008|Z|specific health needs.||
1490|009|B|||
1490|010|T|PANCRELIPASE - ORAL||
1490|011|F|(PAN-kree-LYE-pase)||
1490|012|B|||
1490|013|C|COMMON BRAND NAME(S): Viokace||
1490|014|B|||
1490|015|U|USES:  This medication is used along with a proton pump inhibitor||
1490|016|U|medicine to treat people who cannot digest food normally. The||
1490|017|U|pancreas is an organ in your body that normally produces enzymes||
1490|018|U|to help you digest food. Certain conditions, such as surgical||
1490|019|U|removal of some or all of the pancreas, or chronic pancreatitis,||
1490|020|U|can decrease the production or release of these enzymes into the||
1490|021|U|bowel (intestine). Pancrelipase contains a mixture of digestive||
1490|022|U|enzymes (from pig pancreas) to help breakdown and digest fats,||
1490|023|U|starches, and proteins in food.||
1490|024|B|||
1490|025|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1490|026|H|Patient Information Leaflet provided by your pharmacist before||
1490|027|H|you start taking pancrelipase and each time you get a refill. If||
1490|028|H|you have any questions, ask your doctor or pharmacist.||
1490|029|H|   Take this medication by mouth, usually with every meal and||
1490|030|H|snack as directed by your doctor. Swallow this medication whole.||
1490|031|H|Do not crush or chew the tablets or keep them in your mouth.||
1490|032|H|Doing so can irritate the mouth/throat and change the way the||
1490|033|H|medication works. Drink plenty of fluids while taking this||
1490|034|H|medication unless your doctor tells you otherwise.||
1490|035|H|   The dosage is based on your medical condition, diet, weight,||
1490|036|H|and response to treatment. Do not take more tablets in a day than||
1490|037|H|prescribed by your doctor. Your condition will not improve any||
1490|038|H|faster, and your risk of side effects will increase.||
1490|039|H|   Your doctor should also prescribe another medicine (proton||
1490|040|H|pump inhibitor such as lansoprazole, omeprazole) to decrease||
1490|041|H|stomach acid. This helps pancrelipase work better by preventing||
1490|042|H|it from breaking down in your stomach.||
1490|043|H|   Use this medication regularly and follow any diet||
1490|044|H|recommendations from your doctor or nutritionist to get the most||
1490|045|H|benefit.||
1490|046|H|   Tell your doctor if your condition lasts or gets worse.||
1490|047|B|||
1490|048|S|SIDE EFFECTS:  Nausea, vomiting, bloating, constipation, or anal||
1490|049|S|itching may occur. If any of these effects last or get worse,||
1490|050|S|tell your doctor or pharmacist promptly.||
1490|051|S|   Remember that this medication has been prescribed because your||
1490|052|S|doctor has judged that the benefit to you is greater than the||
1490|053|S|risk of side effects. Many people using this medication do not||
1490|054|S|have serious side effects.||
1490|055|S|   Tell your doctor right away if you have any serious side||
1490|056|S|effects, including: severe stomach/abdominal pain.||
1490|057|S|   A very serious allergic reaction to this drug is rare.||
1490|058|S|However, get medical help right away if you notice any symptoms||
1490|059|S|of a serious allergic reaction, including: rash, itching/swelling||
1490|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1490|061|S|breathing.||
1490|062|S|   This is not a complete list of possible side effects. If you||
1490|063|S|notice other effects not listed above, contact your doctor or||
1490|064|S|pharmacist.||
1490|065|S|   In the US -||
1490|066|S|   Call your doctor for medical advice about side effects. You||
1490|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1490|068|S|www.fda.gov/medwatch.||
1490|069|S|   In Canada - Call your doctor for medical advice about side||
1490|070|S|effects. You may report side effects to Health Canada at||
1490|071|S|1-866-234-2345.||
1490|072|B|||
1490|073|P|PRECAUTIONS:  Before taking pancrelipase, tell your doctor or||
1490|074|P|pharmacist if you are allergic to it; or to pork products; or if||
1490|075|P|you have any other allergies. This product may contain inactive||
1490|076|P|ingredients, which can cause allergic reactions or other||
1490|077|P|problems. Talk to your pharmacist for more details.||
1490|078|P|   Before using this medication, tell your doctor or pharmacist||
1490|079|P|your medical history, especially of: gout, kidney disease, high||
1490|080|P|uric acid level in the blood (hyperuricemia), intestinal problems||
1490|081|P|(such as blockage).||
1490|082|P|   If you have diabetes, pancrelipase may affect your blood||
1490|083|P|sugar. Check your blood sugar regularly as directed and share the||
1490|084|P|results with your doctor. Your doctor may need to adjust your||
1490|085|P|diabetes medication, exercise program, or diet.||
1490|086|P|   Before having surgery, tell your doctor or dentist about all||
1490|087|P|the products you use (including prescription drugs,||
1490|088|P|nonprescription drugs, and herbal products).||
1490|089|P|   During pregnancy, this medication should be used only when||
1490|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
1490|091|P|   It is unknown if this drug passes into breast milk. Consult||
1490|092|P|your doctor before breastfeeding.||
1490|093|B|||
1490|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1490|095|I|medications work or increase your risk for serious side effects.||
1490|096|I|This document does not contain all possible drug interactions.||
1490|097|I|Keep a list of all the products you use (including||
1490|098|I|prescription/nonprescription drugs and herbal products) and share||
1490|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
1490|100|I|the dosage of any medicines without your doctor's approval.||
1490|101|I|   Some products that may interact with this drug include:||
1490|102|I|acarbose, miglitol.||
1490|103|B|||
1490|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1490|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1490|106|O|poison control center right away. US residents can call||
1490|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1490|108|B|||
1490|109|N|NOTES:  Do not share this product with others.||
1490|110|N|   Do not change brands or dosage forms of pancrelipase without||
1490|111|N|consulting your doctor or pharmacist. Different products may||
1490|112|N|contain different amounts of digestive enzymes.||
1490|113|B|||
1490|114|D|MISSED DOSE:  If you miss a dose, take the next dose with your||
1490|115|D|next meal or snack as directed. Do not double the dose to catch||
1490|116|D|up.||
1490|117|B|||
1490|118|R|STORAGE:  Store in the original bottle at room temperature away||
1490|119|R|from light and moisture. Do not store in the bathroom. Keep the||
1490|120|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1490|121|R|when not in use. Keep all medications away from children and||
1490|122|R|pets.||
1490|123|R|   Do not flush medications down the toilet or pour them into a||
1490|124|R|drain unless instructed to do so. Properly discard this product||
1490|125|R|when it is expired or no longer needed. Consult your pharmacist||
1490|126|R|or local waste disposal company.||
1490|127|B|||
1490|128|A|Information last revised August 2025.||
1490|129|A|Copyright(c) 2025 First Databank, Inc.||
1490|130|B|||
1491|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1491|002|Z|does NOT have all possible information about this product. This||
1491|003|Z|information does not assure that this product is safe, effective,||
1491|004|Z|or appropriate for you. This information is not individual||
1491|005|Z|medical advice and does not substitute for the advice of your||
1491|006|Z|health care professional. Always ask your health care||
1491|007|Z|professional for complete information about this product and your||
1491|008|Z|specific health needs.||
1491|009|B|||
1491|010|T|IMIQUIMOD 2.5% - TOPICAL||
1491|011|F|(im-I-kwi-mod)||
1491|012|B|||
1491|013|C|COMMON BRAND NAME(S): Zyclara||
1491|014|B|||
1491|015|U|USES:  Imiquimod is used to treat actinic keratoses (AK), which||
1491|016|U|are precancerous growths on the skin. AK are caused by too much||
1491|017|U|sun exposure. Treating this condition can decrease the risk of||
1491|018|U|complications from them. Imiquimod belongs to a group of drugs||
1491|019|U|called immune response modifiers. It is believed to work by||
1491|020|U|helping your immune system to fight these abnormal skin growths.||
1491|021|B|||
1491|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1491|023|H|from your pharmacist before you start using imiquimod and each||
1491|024|H|time you get a refill. If you have any questions, ask your doctor||
1491|025|H|or pharmacist.||
1491|026|H|   Use this medication on the skin only. Apply this medication to||
1491|027|H|the affected area once a day for 2 weeks as directed by your||
1491|028|H|doctor. You will then rest the treated skin for the next two||
1491|029|H|weeks by not applying any more imiquimod. After this rest period,||
1491|030|H|you will resume applying this medication once a day for another 2||
1491|031|H|weeks.||
1491|032|H|   Do not apply this medication to broken skin (such as open||
1491|033|H|wounds, infected areas, rash, burns). Also, do not apply this||
1491|034|H|medication in the eyes, nose, mouth, rectum, or vagina. If you||
1491|035|H|get this medication in those areas, flush with plenty of water.||
1491|036|H|If irritation occurs, talk to your doctor right away.||
1491|037|H|   If you are using the pump, prime the pump as directed before||
1491|038|H|using it for the first time. If you are using the packet, use a||
1491|039|H|new packet of cream for each use. Throw away any partly used||
1491|040|H|packets of medication.||
1491|041|H|   Use this medication regularly in order to get the most benefit||
1491|042|H|from it. To help you remember, use it at the same time each day.||
1491|043|H|Before applying the medication, wash your hands and the area to||
1491|044|H|be treated with soap and water, and dry thoroughly. Apply as||
1491|045|H|directed by your doctor just before going to bed. Wash your hands||
1491|046|H|with soap and water after each application. Do not cover the||
1491|047|H|treated area with bandages or other waterproof coverings. Leave||
1491|048|H|the cream on overnight, usually for about 8 hours. In the||
1491|049|H|morning, wash the treated area with soap and water to remove the||
1491|050|H|cream. Do not bathe or wet the treated area before the prescribed||
1491|051|H|application time has passed. Do not use more imiquimod than||
1491|052|H|prescribed or leave it on longer than prescribed by your doctor.||
1491|053|H|Doing so increases the risk of severe skin reactions.||
1491|054|H|   Tell your doctor if your condition lasts or gets worse or if||
1491|055|H|new growths appear during treatment.||
1491|056|B|||
1491|057|S|SIDE EFFECTS:  Treatment area reactions may include redness,||
1491|058|S|swelling, itching, burning, pain/tenderness, thickening/hardening||
1491|059|S|of the skin, peeling/flaking/scabbing/crusting, or leaking a||
1491|060|S|clear fluid. Also, changes in skin color may occur and may not go||
1491|061|S|away. If any of these effects last or get worse, tell your doctor||
1491|062|S|or pharmacist promptly.||
1491|063|S|   If the skin reaction is severe (bleeding, formation of||
1491|064|S|sores/blisters/ulcers), imiquimod may need to be temporarily||
1491|065|S|stopped so that the skin can heal. Follow your doctor's||
1491|066|S|directions.||
1491|067|S|   Dizziness, diarrhea, back pain, mouth sores, or swollen lips||
1491|068|S|may also occur. If any of these effects last or get worse, tell||
1491|069|S|your doctor or pharmacist promptly.||
1491|070|S|   Remember that this medication has been prescribed because your||
1491|071|S|doctor has judged that the benefit to you is greater than the||
1491|072|S|risk of side effects. Many people using this medication do not||
1491|073|S|have serious side effects.||
1491|074|S|   Tell your doctor right away if you have any serious side||
1491|075|S|effects, including: flu-like symptoms (such as fever, tiredness,||
1491|076|S|muscle aches), swollen lymph nodes, new unusual skin||
1491|077|S|growths/changes.||
1491|078|S|   A very serious allergic reaction to this drug is rare.||
1491|079|S|However, get medical help right away if you notice any symptoms||
1491|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1491|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1491|082|S|breathing.||
1491|083|S|   This is not a complete list of possible side effects. If you||
1491|084|S|notice other effects not listed above, contact your doctor or||
1491|085|S|pharmacist.||
1491|086|S|   In the US -||
1491|087|S|   Call your doctor for medical advice about side effects. You||
1491|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1491|089|S|www.fda.gov/medwatch.||
1491|090|S|   In Canada - Call your doctor for medical advice about side||
1491|091|S|effects. You may report side effects to Health Canada at||
1491|092|S|1-866-234-2345.||
1491|093|B|||
1491|094|P|PRECAUTIONS:  Before using imiquimod, tell your doctor or||
1491|095|P|pharmacist if you are allergic to it; or if you have any other||
1491|096|P|allergies. This product may contain inactive ingredients, which||
1491|097|P|can cause allergic reactions or other problems. Talk to your||
1491|098|P|pharmacist for more details.||
1491|099|P|   Before using this medication, tell your doctor or pharmacist||
1491|100|P|your medical history, especially of: immune system problems.||
1491|101|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1491|102|P|can make you more dizzy. Do not drive, use machinery, or do||
1491|103|P|anything that needs alertness until you can do it safely. Limit||
1491|104|P|alcoholic beverages. Talk to your doctor if you are using||
1491|105|P|marijuana (cannabis).||
1491|106|P|   This medication may make you more sensitive to the sun. Limit||
1491|107|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1491|108|P|sunscreen and wear protective clothing when outdoors. Do not||
1491|109|P|apply this medication onto sunburned skin. Tell your doctor right||
1491|110|P|away if you get sunburned or have skin blisters/redness.||
1491|111|P|   Before having surgery, tell your doctor or dentist about all||
1491|112|P|the products you use (including prescription drugs,||
1491|113|P|nonprescription drugs, and herbal products).||
1491|114|P|   During pregnancy, this medication should be used only when||
1491|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
1491|116|P|   It is unknown if this drug passes into breast milk. Consult||
1491|117|P|your doctor before breastfeeding.||
1491|118|B|||
1491|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1491|120|I|medications work or increase your risk for serious side effects.||
1491|121|I|This document does not contain all possible drug interactions.||
1491|122|I|Keep a list of all the products you use (including||
1491|123|I|prescription/nonprescription drugs and herbal products) and share||
1491|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
1491|125|I|the dosage of any medicines without your doctor's approval.||
1491|126|I|   Do not apply this product on the same area of skin with other||
1491|127|I|imiquimod-containing products.||
1491|128|B|||
1491|129|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1491|130|O|has overdosed and has serious symptoms such as passing out or||
1491|131|O|trouble breathing, call 911. Otherwise, call a poison control||
1491|132|O|center right away. US residents can call 1-800-222-1222. Canada||
1491|133|O|residents can call 1-844-764-7669.||
1491|134|B|||
1491|135|N|NOTES:  Do not share this medication with others.||
1491|136|N|   Keep all medical appointments.||
1491|137|B|||
1491|138|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1491|139|D|If you do not remember until the next day, skip the missed dose.||
1491|140|D|Use your next dose at the regular time in the evening. Do not||
1491|141|D|double the dose to catch up.||
1491|142|B|||
1491|143|R|STORAGE:  Store at room temperature. Do not freeze. Store the||
1491|144|R|pump upright. Keep all medications away from children and pets.||
1491|145|R|   Do not flush medications down the toilet or pour them into a||
1491|146|R|drain unless instructed to do so. Properly discard this product||
1491|147|R|when it is expired or no longer needed. Consult your pharmacist||
1491|148|R|or local waste disposal company.||
1491|149|B|||
1491|150|A|Information last revised October 2024.||
1491|151|A|Copyright(c) 2025 First Databank, Inc.||
1491|152|B|||
1492|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1492|002|Z|does NOT have all possible information about this product. This||
1492|003|Z|information does not assure that this product is safe, effective,||
1492|004|Z|or appropriate for you. This information is not individual||
1492|005|Z|medical advice and does not substitute for the advice of your||
1492|006|Z|health care professional. Always ask your health care||
1492|007|Z|professional for complete information about this product and your||
1492|008|Z|specific health needs.||
1492|009|B|||
1492|010|T|ZIV-AFLIBERCEPT - INJECTION||
1492|011|F|(a-FLIB-er-sept)||
1492|012|B|||
1492|013|C|COMMON BRAND NAME(S): Zaltrap||
1492|014|B|||
1492|015|U|USES:  Ziv-aflibercept is used to treat cancer of the colon and||
1492|016|U|rectum.||
1492|017|B|||
1492|018|H|HOW TO USE:  This medication is given by injection into a vein by||
1492|019|H|a health care professional. It is given as directed by your||
1492|020|H|doctor, usually every 2 weeks. The medication is injected slowly||
1492|021|H|into a vein over 1 hour.||
1492|022|H|   The dosage is based on your medical condition, weight, and||
1492|023|H|response to treatment.||
1492|024|H|   Use this medication regularly to get the most benefit from it.||
1492|025|H|To help you remember, mark your calendar with a reminder.||
1492|026|B|||
1492|027|S|SIDE EFFECTS:  Diarrhea, headache, mouth pain/sores, runny nose,||
1492|028|S|voice changes, weight loss, weakness, tiredness, or darkening of||
1492|029|S|the skin may occur. If any of these effects last or get worse,||
1492|030|S|tell your doctor or pharmacist promptly.||
1492|031|S|   Remember that this medication has been prescribed because your||
1492|032|S|doctor has judged that the benefit to you is greater than the||
1492|033|S|risk of side effects. Many people using this medication do not||
1492|034|S|have serious side effects.||
1492|035|S|   Tell your doctor right away if you have any serious side||
1492|036|S|effects, including: diarrhea that is severe or doesn't stop,||
1492|037|S|signs of kidney problems (such as change in the amount of urine),||
1492|038|S|swelling hands/ankles/feet, signs of dehydration (such as muscle||
1492|039|S|cramps, extreme thirst, dizziness),||
1492|040|S|pain/redness/swelling/tingling/burning of the hands/feet, slow||
1492|041|S|wound healing.||
1492|042|S|   Get medical help right away if you have any very serious side||
1492|043|S|effects, including: chest/jaw/left arm pain, weakness on one side||
1492|044|S|of the body, trouble speaking, confusion, sudden vision changes,||
1492|045|S|seizure, sudden/severe back pain or headache.||
1492|046|S|   This medication may cause serious (possibly fatal) bleeding.||
1492|047|S|It may also rarely cause a hole to open in the stomach or||
1492|048|S|intestines (gastrointestinal perforation). Tell your doctor right||
1492|049|S|away if you have symptoms such as stomach/abdominal pain that||
1492|050|S|doesn't go away, easy or unusual bleeding/bruising (such as from||
1492|051|S|cuts, gums, nosebleeds), pink/dark urine, bloody or black/tarry||
1492|052|S|stools, vomit that looks like coffee grounds, coughing up blood,||
1492|053|S|lightheadedness, unusual tiredness/weakness.||
1492|054|S|   This medication may lower your ability to fight infections.||
1492|055|S|This may make you more likely to get a serious (rarely fatal)||
1492|056|S|infection or make any infection you have worse. Tell your doctor||
1492|057|S|right away if you have any signs of infection (such as sore||
1492|058|S|throat that doesn't go away, fever, chills).||
1492|059|S|   This medication may raise your blood pressure. Check your||
1492|060|S|blood pressure regularly and tell your doctor if the results are||
1492|061|S|high. Your doctor may control your blood pressure with||
1492|062|S|medication.||
1492|063|S|   A very serious allergic reaction to this drug is rare.||
1492|064|S|However, get medical help right away if you notice any symptoms||
1492|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1492|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1492|067|S|breathing.||
1492|068|S|   This is not a complete list of possible side effects. If you||
1492|069|S|notice other effects not listed above, contact your doctor or||
1492|070|S|pharmacist.||
1492|071|S|   In the US -||
1492|072|S|   Call your doctor for medical advice about side effects. You||
1492|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1492|074|S|www.fda.gov/medwatch.||
1492|075|S|   In Canada - Call your doctor for medical advice about side||
1492|076|S|effects. You may report side effects to Health Canada at||
1492|077|S|1-866-234-2345.||
1492|078|B|||
1492|079|P|PRECAUTIONS:  Before receiving ziv-aflibercept, tell your doctor||
1492|080|P|or pharmacist if you are allergic to it; or to aflibercept; or if||
1492|081|P|you have any other allergies. This product may contain inactive||
1492|082|P|ingredients, which can cause allergic reactions or other||
1492|083|P|problems. Talk to your pharmacist for more details.||
1492|084|P|   Before using this medication, tell your doctor or pharmacist||
1492|085|P|your medical history, especially of: high blood pressure, kidney||
1492|086|P|disease, recent surgery, recent injuries/wounds, recent/current||
1492|087|P|infection, blood/bone marrow disorders (such as low||
1492|088|P|platelet/neutrophil/red blood cell levels), bleeding problems||
1492|089|P|(such as bleeding of the stomach/intestines), blood vessel||
1492|090|P|problems (such as an aneurysm or a tear/break in the aorta or||
1492|091|P|other blood vessels).||
1492|092|P|   Before having surgery or any medical procedure, tell your||
1492|093|P|doctor or dentist about all the products you use (including||
1492|094|P|prescription drugs, nonprescription drugs, and herbal products).||
1492|095|P|   This medication may cause wounds to heal slowly or poorly. You||
1492|096|P|should not receive this medication for at least 4 weeks before||
1492|097|P|and at least 4 weeks after major surgery, until wounds from the||
1492|098|P|surgery are fully healed. Ask your doctor for specific||
1492|099|P|instructions about when to stop and when to restart treatment||
1492|100|P|with this medication.||
1492|101|P|   Ziv-aflibercept can make you more likely to get infections or||
1492|102|P|may make current infections worse. Stay away from anyone who has||
1492|103|P|an infection that may easily spread (such as chickenpox,||
1492|104|P|COVID-19, measles, flu). Talk to your doctor if you have been||
1492|105|P|exposed to an infection or for more details.||
1492|106|P|   Tell your health care professional that you are using||
1492|107|P|ziv-aflibercept before having any immunizations/vaccinations.||
1492|108|P|Avoid contact with people who have recently received live||
1492|109|P|vaccines (such as flu vaccine inhaled through the nose).||
1492|110|P|   To lower the chance of getting cut, bruised, or injured, use||
1492|111|P|caution with sharp objects like razors and nail cutters, and||
1492|112|P|avoid activities such as contact sports.||
1492|113|P|   Older adults may be more sensitive to the side effects of this||
1492|114|P|drug, especially diarrhea, dehydration, weight loss, and||
1492|115|P|weakness.||
1492|116|P|   Tell your doctor if you are pregnant or plan to become||
1492|117|P|pregnant. You should not become pregnant while using||
1492|118|P|ziv-aflibercept. Ziv-aflibercept may harm an unborn baby. Your||
1492|119|P|doctor should order a pregnancy test before you start this||
1492|120|P|medication. Ask about reliable forms of birth control while using||
1492|121|P|this medication and for 3 months after the last dose. If you||
1492|122|P|become pregnant, talk to your doctor right away about the risks||
1492|123|P|and benefits of this medication.||
1492|124|P|   It is unknown if this medication passes into breast milk.||
1492|125|P|Because of the possible risk to the infant, breastfeeding is not||
1492|126|P|recommended while using this medication and for 1 month after the||
1492|127|P|last dose. Consult your doctor before breastfeeding.||
1492|128|B|||
1492|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1492|130|I|medications work or increase your risk for serious side effects.||
1492|131|I|This document does not contain all possible drug interactions.||
1492|132|I|Keep a list of all the products you use (including||
1492|133|I|prescription/nonprescription drugs and herbal products) and share||
1492|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
1492|135|I|the dosage of any medicines without your doctor's approval.||
1492|136|I|   Ziv-aflibercept is very similar to aflibercept. Do not use||
1492|137|I|ziv-aflibercept while using the form of aflibercept that is also||
1492|138|I|given by injection into a vein.||
1492|139|B|||
1492|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1492|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1492|142|O|poison control center right away. US residents can call||
1492|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1492|144|B|||
1492|145|N|NOTES:  Lab and/or medical tests (such as blood pressure, urine||
1492|146|N|protein, complete blood count, liver function) should be done||
1492|147|N|while you are using this medication. Keep all medical and lab||
1492|148|N|appointments.||
1492|149|B|||
1492|150|D|MISSED DOSE:  It is important to get each dose of this medication||
1492|151|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1492|152|D|right away for a new dosing schedule.||
1492|153|B|||
1492|154|R|STORAGE:  Not applicable. This medication is given in a hospital||
1492|155|R|or clinic and will not be stored at home.||
1492|156|B|||
1492|157|M|MEDICAL ALERT:  Your condition can cause complications in a||
1492|158|M|medical emergency. For information about enrolling in MedicAlert,||
1492|159|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1492|160|B|||
1492|161|A|Information last revised April 2025.||
1492|162|A|Copyright(c) 2025 First Databank, Inc.||
1492|163|B|||
1493|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1493|002|Z|does NOT have all possible information about this product. This||
1493|003|Z|information does not assure that this product is safe, effective,||
1493|004|Z|or appropriate for you. This information is not individual||
1493|005|Z|medical advice and does not substitute for the advice of your||
1493|006|Z|health care professional. Always ask your health care||
1493|007|Z|professional for complete information about this product and your||
1493|008|Z|specific health needs.||
1493|009|B|||
1493|010|T|ALENDRONATE EFFERVESCENT WEEKLY - ORAL||
1493|011|F|(a-LEN-droe-nate)||
1493|012|B|||
1493|013|C|COMMON BRAND NAME(S): Binosto||
1493|014|B|||
1493|015|U|USES:  Alendronate is used to prevent and treat certain types of||
1493|016|U|bone loss (osteoporosis) in adults. Osteoporosis causes bones to||
1493|017|U|become thinner and break more easily. Your chance of developing||
1493|018|U|osteoporosis increases as you age, after menopause, or if you are||
1493|019|U|taking corticosteroid medications (such as prednisone) for a long||
1493|020|U|time.||
1493|021|U|   This medication works by slowing bone loss. This effect helps||
1493|022|U|maintain strong bones and reduce the risk of broken bones||
1493|023|U|(fractures). Alendronate belongs to a class of drugs called||
1493|024|U|bisphosphonates.||
1493|025|B|||
1493|026|H|HOW TO USE:  Read the Medication Guide provided by your||
1493|027|H|pharmacist before you start taking alendronate and each time you||
1493|028|H|get a refill. If you have any questions, ask your doctor or||
1493|029|H|pharmacist.||
1493|030|H|   Take this medication by mouth as directed by your doctor,||
1493|031|H|usually once a week. Choose the day of the week that best fits||
1493|032|H|your schedule and take it on that day each week.||
1493|033|H|   Take this medication after getting up for the day and before||
1493|034|H|taking your first food, beverage, or other medication. Do not||
1493|035|H|swallow, chew, or suck on the tablet since this may cause||
1493|036|H|mouth/throat irritation or ulcers. You must dissolve the tablet||
1493|037|H|before you take it. Place the tablet in 4 ounces/120 milliliters||
1493|038|H|plain water (not mineral water or flavored water) at room||
1493|039|H|temperature. After bubbling from the tablet stops, wait at least||
1493|040|H|5 minutes until it is completely dissolved. Then stir the liquid||
1493|041|H|for about 10 seconds and drink all of it. Stay fully upright||
1493|042|H|(sitting, standing, or walking) for at least 30 minutes and do||
1493|043|H|not lie down until after your first food of the day.||
1493|044|H|   Alendronate works best if taken on an empty stomach. Calcium||
1493|045|H|or iron supplements, vitamins, antacids, coffee, tea, soda,||
1493|046|H|mineral water, juice with added calcium, and food can decrease||
1493|047|H|the absorption of alendronate. Wait at least 30 minutes||
1493|048|H|(preferably 1 to 2 hours) after taking the medication before you||
1493|049|H|eat or drink anything except plain water.||
1493|050|H|   Do not take this medication at bedtime or before rising for||
1493|051|H|the day. It may not be absorbed and you may have serious side||
1493|052|H|effects.||
1493|053|H|   Take this medication regularly to get the most benefit from||
1493|054|H|it. To help you remember, take it on the same day each week. Mark||
1493|055|H|your calendar with a reminder. Talk to your doctor about the||
1493|056|H|risks and benefits of long-term use of this medication.||
1493|057|B|||
1493|058|S|SIDE EFFECTS:  Stomach pain, constipation, diarrhea, gas, or||
1493|059|S|nausea may occur. If any of these effects last or get worse, tell||
1493|060|S|your doctor or pharmacist promptly.||
1493|061|S|   Remember that this medication has been prescribed because your||
1493|062|S|doctor has judged that the benefit to you is greater than the||
1493|063|S|risk of side effects. Many people using this medication do not||
1493|064|S|have serious side effects.||
1493|065|S|   Tell your doctor right away if you have any serious side||
1493|066|S|effects, including: jaw/ear pain, swelling of||
1493|067|S|joints/hands/ankles/feet, increased or severe bone/joint/muscle||
1493|068|S|pain, symptoms of thigh bone fracture (such as new or unusual||
1493|069|S|hip/thigh/groin pain), symptoms of low calcium levels in the||
1493|070|S|blood (such as muscle spasm/cramps, tingling/numbness in your||
1493|071|S|fingers, toes, or around your mouth), black/tarry stools, vomit||
1493|072|S|that looks like coffee grounds.||
1493|073|S|   This medication may rarely cause serious irritation and ulcers||
1493|074|S|of the esophagus. If you notice any of the following unlikely but||
1493|075|S|very serious side effects, stop taking alendronate and talk to||
1493|076|S|your doctor or pharmacist right away: new or worsening heartburn,||
1493|077|S|chest pain, pain or difficulty when swallowing.||
1493|078|S|   A very serious allergic reaction to this drug is rare.||
1493|079|S|However, get medical help right away if you notice any symptoms||
1493|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1493|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1493|082|S|breathing.||
1493|083|S|   This is not a complete list of possible side effects. If you||
1493|084|S|notice other effects not listed above, contact your doctor or||
1493|085|S|pharmacist.||
1493|086|S|   In the US -||
1493|087|S|   Call your doctor for medical advice about side effects. You||
1493|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1493|089|S|www.fda.gov/medwatch.||
1493|090|S|   In Canada - Call your doctor for medical advice about side||
1493|091|S|effects. You may report side effects to Health Canada at||
1493|092|S|1-866-234-2345.||
1493|093|B|||
1493|094|P|PRECAUTIONS:  Before taking alendronate, tell your doctor or||
1493|095|P|pharmacist if you are allergic to it; or to other||
1493|096|P|bisphosphonates; or if you have any other allergies. This product||
1493|097|P|may contain inactive ingredients, which can cause allergic||
1493|098|P|reactions or other problems. Talk to your pharmacist for more||
1493|099|P|details.||
1493|100|P|   Before using this medication, tell your doctor or pharmacist||
1493|101|P|your medical history, especially of: disorders of the esophagus||
1493|102|P|(such as narrowing, trouble swallowing), trouble standing or||
1493|103|P|sitting upright for at least 30 minutes, low calcium levels,||
1493|104|P|kidney problems, stomach/intestinal disorders (such as heartburn,||
1493|105|P|ulcers).||
1493|106|P|   Some people taking alendronate may have serious jawbone||
1493|107|P|problems. Your doctor should check your mouth before you start||
1493|108|P|this medication. Tell your dentist that you are taking this||
1493|109|P|medication before you have any dental work done. To help prevent||
1493|110|P|jawbone problems, have regular dental exams and learn how to keep||
1493|111|P|your teeth and gums healthy. If you have jaw pain, tell your||
1493|112|P|doctor and dentist right away.||
1493|113|P|   This medication contains salt (sodium). Before taking this||
1493|114|P|medication, tell your doctor or pharmacist if you are on a||
1493|115|P|low-salt diet.||
1493|116|P|   Before having any surgery (especially dental procedures), tell||
1493|117|P|your doctor and dentist about this medication and all the||
1493|118|P|products you use (including prescription drugs, nonprescription||
1493|119|P|drugs, and herbal products). Your doctor or dentist may tell you||
1493|120|P|to stop taking alendronate before your surgery. Follow all||
1493|121|P|instructions about stopping or starting this medication.||
1493|122|P|   This drug is not recommended for use in children. Studies have||
1493|123|P|shown that many children who took this drug had severe side||
1493|124|P|effects such as vomiting, fever, and flu-like symptoms.||
1493|125|P|   Tell your doctor if you are pregnant or plan to become||
1493|126|P|pregnant. Alendronate may stay in your body for many years. You||
1493|127|P|should not become pregnant while using alendronate. Discuss the||
1493|128|P|risks and benefits with your doctor.||
1493|129|P|   It is unknown if this medication passes into breast milk.||
1493|130|P|Consult your doctor before breastfeeding.||
1493|131|B|||
1493|132|I|DRUG INTERACTIONS:  See also How to Use section.||
1493|133|I|   Drug interactions may change how your medications work or||
1493|134|I|increase your risk for serious side effects. This document does||
1493|135|I|not contain all possible drug interactions. Keep a list of all||
1493|136|I|the products you use (including prescription/nonprescription||
1493|137|I|drugs and herbal products) and share it with your doctor and||
1493|138|I|pharmacist. Do not start, stop, or change the dosage of any||
1493|139|I|medicines without your doctor's approval.||
1493|140|B|||
1493|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1493|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1493|143|O|poison control center right away. US residents can call||
1493|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1493|145|O|Symptoms of overdose may include: severe stomach pain, painful||
1493|146|O|heartburn, pain in the esophagus (chest pain), muscle||
1493|147|O|weakness/cramps, mental/mood changes.||
1493|148|B|||
1493|149|N|NOTES:  Do not share this medication with others.||
1493|150|N|   Lifestyle changes that help promote healthy bones include||
1493|151|N|increasing weight-bearing exercise, stopping smoking, limiting||
1493|152|N|alcohol, and eating well-balanced meals that contain adequate||
1493|153|N|calcium and vitamin D. You may also need to take calcium and||
1493|154|N|vitamin D supplements. Consult your doctor for specific advice.||
1493|155|N|   Lab and/or medical tests (X-rays, height measurement, blood||
1493|156|N|mineral levels) should be done while you are taking this||
1493|157|N|medication. Keep all medical and lab appointments. Consult your||
1493|158|N|doctor for more details.||
1493|159|B|||
1493|160|D|MISSED DOSE:  If you miss a dose, take it the next morning after||
1493|161|D|you remember. Then go back to your weekly dosing schedule on your||
1493|162|D|usual day of the week. Do not take two doses on the same day.||
1493|163|B|||
1493|164|R|STORAGE:  Store at room temperature away from light and moisture.||
1493|165|R|Do not store in the bathroom. Keep all medications away from||
1493|166|R|children and pets.||
1493|167|R|   Do not flush medications down the toilet or pour them into a||
1493|168|R|drain unless instructed to do so. Properly discard this product||
1493|169|R|when it is expired or no longer needed. Consult your pharmacist||
1493|170|R|or local waste disposal company.||
1493|171|B|||
1493|172|A|Information last revised September 2025.||
1493|173|A|Copyright(c) 2025 First Databank, Inc.||
1493|174|B|||
1494|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1494|002|Z|does NOT have all possible information about this product. This||
1494|003|Z|information does not assure that this product is safe, effective,||
1494|004|Z|or appropriate for you. This information is not individual||
1494|005|Z|medical advice and does not substitute for the advice of your||
1494|006|Z|health care professional. Always ask your health care||
1494|007|Z|professional for complete information about this product and your||
1494|008|Z|specific health needs.||
1494|009|B|||
1494|010|T|ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR - ORAL||
1494|011|F|(EL-vi-TEG-ra-vir/koe-BIK-i-stat/EM-trye-SYE-ta-been/||
1494|012|F|ten-OF-oh-vir)||
1494|013|B|||
1494|014|C|COMMON BRAND NAME(S): Stribild||
1494|015|B|||
1494|016|W|WARNING:  If you have hepatitis B infection, your hepatitis||
1494|017|W|symptoms may get worse or become very serious if you stop taking||
1494|018|W|this medication. Talk with your doctor before stopping this||
1494|019|W|medication. Your doctor will monitor liver tests for several||
1494|020|W|months after you stop||
1494|021|W|elvitegravir/cobicistat/emtricitabine/tenofovir. Tell your doctor||
1494|022|W|right away if you have symptoms of worsening liver problems.||
1494|023|B|||
1494|024|U|USES:  This product is used to help control HIV infection. It||
1494|025|U|helps to decrease the amount of HIV in your body so your immune||
1494|026|U|system can work better. This lowers your chance of getting HIV||
1494|027|U|complications (such as new infections, cancer) and improves your||
1494|028|U|quality of life. This product contains 4 different medications:||
1494|029|U|elvitegravir, cobicistat, emtricitabine, and tenofovir.||
1494|030|U|Elvitegravir is known as an integrase inhibitor. Cobicistat helps||
1494|031|U|elvitegravir work better. Emtricitabine is called a nucleoside||
1494|032|U|reverse transcriptase inhibitor, while tenofovir is called a||
1494|033|U|nucleotide reverse transcriptase inhibitor; they are often called||
1494|034|U|NRTIs.||
1494|035|U|   Elvitegravir/cobicistat/emtricitabine/tenofovir is not a cure||
1494|036|U|for HIV infection. To decrease your risk of spreading HIV disease||
1494|037|U|to others, continue to take all HIV medications exactly as||
1494|038|U|prescribed by your doctor. Use an effective barrier method (latex||
1494|039|U|or polyurethane condoms/dental dams) during sexual activity as||
1494|040|U|directed by your doctor. Do not share personal items (such as||
1494|041|U|needles/syringes, toothbrushes, and razors) that may have||
1494|042|U|contacted blood or other body fluids. Consult your doctor or||
1494|043|U|pharmacist for more details.||
1494|044|B|||
1494|045|V|OTHER USES:  This section contains uses of this drug that are not||
1494|046|V|listed in the approved professional labeling for the drug but||
1494|047|V|that may be prescribed by your health care professional. Use this||
1494|048|V|drug for a condition that is listed in this section only if it||
1494|049|V|has been so prescribed by your health care professional.||
1494|050|V|   This product may also be used to lessen the risk of HIV||
1494|051|V|infection after contact with the virus (for example, due to a||
1494|052|V|needle stick). Ask your doctor for more details.||
1494|053|B|||
1494|054|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1494|055|H|from your pharmacist before you start taking this medication and||
1494|056|H|each time you get a refill. If you have any questions, ask your||
1494|057|H|doctor or pharmacist.||
1494|058|H|   Take this medication by mouth with food as directed by your||
1494|059|H|doctor, usually once daily.||
1494|060|H|   It is very important to keep taking this medication exactly as||
1494|061|H|prescribed by your doctor. Do not skip any doses.||
1494|062|H|   Take this medication at least 2 hours before or 2 hours after||
1494|063|H|taking other products that may make it work less well. Some||
1494|064|H|examples include: sucralfate, antacids, and vitamins/minerals||
1494|065|H|that contain magnesium, aluminum, calcium, iron, or zinc.||
1494|066|H|   For the best effect, take this medication at evenly spaced||
1494|067|H|times. To help you remember, take this medication at the same||
1494|068|H|time every day.||
1494|069|H|   Do not take more or less of this drug than prescribed or stop||
1494|070|H|taking it even for a short time unless directed to do so by your||
1494|071|H|doctor. Doing so may cause the amount of virus to increase, make||
1494|072|H|the infection more difficult to treat (resistant), or worsen side||
1494|073|H|effects.||
1494|074|B|||
1494|075|S|SIDE EFFECTS:  Diarrhea, headache, dizziness, trouble sleeping,||
1494|076|S|unusual dreams, back pain, or change in the color of skin on your||
1494|077|S|palms or soles of your feet may occur. If any of these effects||
1494|078|S|last or get worse, tell your doctor or pharmacist promptly.||
1494|079|S|   Remember that this medication has been prescribed because your||
1494|080|S|doctor has judged that the benefit to you is greater than the||
1494|081|S|risk of side effects. Many people using this medication do not||
1494|082|S|have serious side effects.||
1494|083|S|   As your immune system gets stronger, it can begin to fight off||
1494|084|S|infections you already had, possibly causing disease symptoms to||
1494|085|S|come back. You could also have symptoms if your immune system||
1494|086|S|becomes overactive. This reaction may happen at any time (soon||
1494|087|S|after starting HIV treatment or many months later). Tell your||
1494|088|S|doctor right away if you have any serious symptoms, including:||
1494|089|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1494|090|S|that doesn't go away, headaches that are severe or don't go away,||
1494|091|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1494|092|S|changes, signs of infection (such as sore throat that doesn't go||
1494|093|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1494|094|S|sores), signs of an overactive thyroid (such as irritability,||
1494|095|S|nervousness, heat intolerance, fast/pounding/irregular||
1494|096|S|heartbeat).||
1494|097|S|   Tell your doctor right away if you have any serious side||
1494|098|S|effects, including: mental/mood changes (such as depression,||
1494|099|S|anxiety), signs of kidney problems (such as change in the amount||
1494|100|S|of urine, pink/bloody urine).||
1494|101|S|   Rarely, this medication can cause severe (sometimes fatal)||
1494|102|S|liver and blood problems (lactic acidosis). Tell your doctor||
1494|103|S|right away if you develop symptoms of liver problems (such as||
1494|104|S|nausea/vomiting that doesn't stop, loss of appetite,||
1494|105|S|stomach/abdominal pain, yellowing eyes/skin, dark urine) or||
1494|106|S|lactic acidosis (such as deep/rapid breathing, drowsiness,||
1494|107|S|nausea/vomiting, unusual weakness).||
1494|108|S|   Tenofovir may increase the risk of bone loss. Discuss the||
1494|109|S|risks and benefits of treatment with your doctor, as well as the||
1494|110|S|possible use of calcium and vitamin D to reduce this side effect.||
1494|111|S|If you are at risk for bone loss, your doctor may monitor your||
1494|112|S|bone mineral density. Tell your doctor right away if any of the||
1494|113|S|following serious side effects occur: bone pain, easily broken||
1494|114|S|bones.||
1494|115|S|   A very serious allergic reaction to this drug is rare.||
1494|116|S|However, get medical help right away if you notice any symptoms||
1494|117|S|of a serious allergic reaction, including: rash, itching/swelling||
1494|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1494|119|S|breathing.||
1494|120|S|   This is not a complete list of possible side effects. If you||
1494|121|S|notice other effects not listed above, contact your doctor or||
1494|122|S|pharmacist.||
1494|123|S|   In the US -||
1494|124|S|   Call your doctor for medical advice about side effects. You||
1494|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1494|126|S|www.fda.gov/medwatch.||
1494|127|S|   In Canada - Call your doctor for medical advice about side||
1494|128|S|effects. You may report side effects to Health Canada at||
1494|129|S|1-866-234-2345.||
1494|130|B|||
1494|131|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1494|132|P|pharmacist if you are allergic to elvitegravir, cobicistat,||
1494|133|P|emtricitabine, or tenofovir; or if you have any other allergies.||
1494|134|P|This product may contain inactive ingredients, which can cause||
1494|135|P|allergic reactions or other problems. Talk to your pharmacist for||
1494|136|P|more details.||
1494|137|P|   Before using this medication, tell your doctor or pharmacist||
1494|138|P|your medical history, especially of: pancreatitis, liver problems||
1494|139|P|(hepatitis B, hepatitis C, cirrhosis), alcohol use, bone problems||
1494|140|P|(such as bone disease, bone loss/osteoporosis, weak/broken||
1494|141|P|bones), kidney disease.||
1494|142|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1494|143|P|can make you more dizzy. Do not drive, use machinery, or do||
1494|144|P|anything that needs alertness until you can do it safely. Limit||
1494|145|P|alcoholic beverages. Talk to your doctor if you are using||
1494|146|P|marijuana (cannabis).||
1494|147|P|   Before having surgery, tell your doctor or dentist about all||
1494|148|P|the products you use (including prescription drugs,||
1494|149|P|nonprescription drugs, and herbal products).||
1494|150|P|   This medication is not recommended for use during pregnancy.||
1494|151|P|It may not work well in a pregnant woman. If you become pregnant||
1494|152|P|or think you may be pregnant, tell your doctor right away. Your||
1494|153|P|doctor may change your HIV medications.||
1494|154|P|   Emtricitabine and tenofovir pass into breast milk. It is||
1494|155|P|unknown if elvitegravir or cobicistat pass into breast milk.||
1494|156|P|Because breast milk may transmit HIV, consult your doctor before||
1494|157|P|breastfeeding.||
1494|158|B|||
1494|159|I|DRUG INTERACTIONS:  See also How To Use section.||
1494|160|I|   Drug interactions may change how your medications work or||
1494|161|I|increase your risk for serious side effects. This document does||
1494|162|I|not contain all possible drug interactions. Keep a list of all||
1494|163|I|the products you use (including prescription/nonprescription||
1494|164|I|drugs and herbal products) and share it with your doctor and||
1494|165|I|pharmacist. Do not start, stop, or change the dosage of any||
1494|166|I|medicines without your doctor's approval.||
1494|167|I|   Some products that may interact with this drug include:||
1494|168|I|adefovir, orlistat, other drugs that may affect the kidneys||
1494|169|I|(including acyclovir, cidofovir, ganciclovir, valacyclovir,||
1494|170|I|valganciclovir, aminoglycosides such as amikacin/gentamicin).||
1494|171|I|   Do not take this medication with other HIV medications (such||
1494|172|I|as ritonavir). Do not take this medication with other products||
1494|173|I|that contain cobicistat, elvitegravir, emtricitabine, lamivudine,||
1494|174|I|or tenofovir.||
1494|175|I|   This medication can slow down the removal of other medications||
1494|176|I|from your body, which may affect how they work. Examples of||
1494|177|I|affected drugs include dronedarone, eletriptan, eplerenone, ergot||
1494|178|I|alkaloids (such as ergotamine, dihydroergotamine), salmeterol,||
1494|179|I|tolvaptan, rivaroxaban, certain alpha blockers (such as||
1494|180|I|alfuzosin, tamsulosin), certain benzodiazepines (such as||
1494|181|I|midazolam, triazolam), certain statins (such as lovastatin,||
1494|182|I|simvastatin), certain drugs to treat erectile dysfunction-ED or||
1494|183|I|pulmonary hypertension (such as avanafil, sildenafil), among||
1494|184|I|others.||
1494|185|I|   Other medications can affect the removal of this medication||
1494|186|I|from your body, which may affect how this medication works.||
1494|187|I|Examples include mitotane, rifampin, St. John's wort, certain||
1494|188|I|drugs used to treat seizures (such as carbamazepine,||
1494|189|I|oxcarbazepine, phenobarbital, phenytoin, primidone), among||
1494|190|I|others.||
1494|191|I|   This medication may decrease the effectiveness of hormonal||
1494|192|I|birth control such as pills, patch, or ring. This could cause||
1494|193|I|pregnancy. This medication may also increase the risk of some||
1494|194|I|hormonal birth control side effects. Talk to your doctor about||
1494|195|I|other reliable forms of birth control, and use an effective||
1494|196|I|barrier method (latex or polyurethane condoms/dental dams) during||
1494|197|I|sexual activity to decrease the risk of spreading HIV to others.||
1494|198|I|Tell your doctor if you have any new spotting or breakthrough||
1494|199|I|bleeding, because these may be signs that your hormonal birth||
1494|200|I|control is not working well.||
1494|201|B|||
1494|202|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1494|203|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1494|204|O|poison control center right away. US residents can call||
1494|205|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1494|206|B|||
1494|207|N|NOTES:  Do not share this medication with others.||
1494|208|N|   Lab and/or medical tests (such as kidney/liver function, test||
1494|209|N|for hepatitis B virus, viral load, T-cell counts, blood mineral||
1494|210|N|levels, bone density tests, urine glucose/protein) should be done||
1494|211|N|before you start taking this medication and while you are taking||
1494|212|N|it. Keep all medical and lab appointments. Consult your doctor||
1494|213|N|for more details.||
1494|214|B|||
1494|215|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1494|216|D|remember. If it is near the time of the next dose, skip the||
1494|217|D|missed dose. Take your next dose at the regular time. Do not||
1494|218|D|double the dose to catch up.||
1494|219|B|||
1494|220|R|STORAGE:  Store in the original container at room temperature||
1494|221|R|away from light and moisture. Do not store in the bathroom. Keep||
1494|222|R|all medications away from children and pets.||
1494|223|R|   Do not flush medications down the toilet or pour them into a||
1494|224|R|drain unless instructed to do so. Properly discard this product||
1494|225|R|when it is expired or no longer needed. Consult your pharmacist||
1494|226|R|or local waste disposal company.||
1494|227|B|||
1494|228|A|Information last revised April 2025.||
1494|229|A|Copyright(c) 2025 First Databank, Inc.||
1494|230|B|||
1495|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1495|002|Z|does NOT have all possible information about this product. This||
1495|003|Z|information does not assure that this product is safe, effective,||
1495|004|Z|or appropriate for you. This information is not individual||
1495|005|Z|medical advice and does not substitute for the advice of your||
1495|006|Z|health care professional. Always ask your health care||
1495|007|Z|professional for complete information about this product and your||
1495|008|Z|specific health needs.||
1495|009|B|||
1495|010|T|MIRABEGRON EXTENDED-RELEASE - ORAL||
1495|011|F|(MIR-a-BEG-ron)||
1495|012|B|||
1495|013|C|COMMON BRAND NAME(S): Myrbetriq||
1495|014|B|||
1495|015|U|USES:  This medication is used to treat certain bladder problems||
1495|016|U|(overactive bladder, neurogenic detrusor overactivity).||
1495|017|U|Overactive bladder is a problem with how your bladder stores||
1495|018|U|urine. Neurogenic detrusor overactivity is a bladder control||
1495|019|U|condition caused by brain, spinal cord, or nerve problems.||
1495|020|U|Symptoms of these conditions may include frequent urination,||
1495|021|U|strong sudden urges to urinate that are hard to control, or||
1495|022|U|involuntary loss of urine (incontinence). Mirabegron works by||
1495|023|U|relaxing a certain bladder muscle (detrusor), which helps the||
1495|024|U|bladder hold more urine and lessens symptoms of overactive||
1495|025|U|bladder and neurogenic detrusor overactivity.||
1495|026|B|||
1495|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1495|028|H|from your pharmacist before you start taking mirabegron and each||
1495|029|H|time you get a refill. If you have any questions, ask your doctor||
1495|030|H|or pharmacist.||
1495|031|H|   Take this medication by mouth as directed by your doctor,||
1495|032|H|usually once daily. Adults may take this medication with or||
1495|033|H|without food. Children should take this medication with food.||
1495|034|H|Swallow this medication whole. Do not crush, chew, or divide the||
1495|035|H|medication. Doing so can release all of the drug at once,||
1495|036|H|increasing the risk of side effects.||
1495|037|H|   The dosage is based on your medical condition and response to||
1495|038|H|treatment. Children's dosage is also based on weight.||
1495|039|H|   Use this medication regularly to get the most benefit from it.||
1495|040|H|To help you remember, take it at the same time each day.||
1495|041|H|   Tell your doctor if your condition does not get better or if||
1495|042|H|it gets worse.||
1495|043|B|||
1495|044|S|SIDE EFFECTS:  Nausea, dizziness, fast heartbeat, runny/stuffy||
1495|045|S|nose, or headache may occur. If any of these effects last or get||
1495|046|S|worse, tell your doctor or pharmacist promptly.||
1495|047|S|   Remember that this medication has been prescribed because your||
1495|048|S|doctor has judged that the benefit to you is greater than the||
1495|049|S|risk of side effects. Many people using this medication do not||
1495|050|S|have serious side effects.||
1495|051|S|   This medication may raise your blood pressure. Check your||
1495|052|S|blood pressure regularly and tell your doctor if the results are||
1495|053|S|high.||
1495|054|S|   Tell your doctor right away if you have any serious side||
1495|055|S|effects, including: burning/painful urination.||
1495|056|S|   A very serious allergic reaction to this drug is rare.||
1495|057|S|However, get medical help right away if you notice any symptoms||
1495|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1495|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1495|060|S|breathing.||
1495|061|S|   This is not a complete list of possible side effects. If you||
1495|062|S|notice other effects not listed above, contact your doctor or||
1495|063|S|pharmacist.||
1495|064|S|   In the US -||
1495|065|S|   Call your doctor for medical advice about side effects. You||
1495|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1495|067|S|www.fda.gov/medwatch.||
1495|068|S|   In Canada - Call your doctor for medical advice about side||
1495|069|S|effects. You may report side effects to Health Canada at||
1495|070|S|1-866-234-2345.||
1495|071|B|||
1495|072|P|PRECAUTIONS:  Before taking mirabegron, tell your doctor or||
1495|073|P|pharmacist if you are allergic to it; or if you have any other||
1495|074|P|allergies. This product may contain inactive ingredients, which||
1495|075|P|can cause allergic reactions or other problems. Talk to your||
1495|076|P|pharmacist for more details.||
1495|077|P|   Before using this medication, tell your doctor or pharmacist||
1495|078|P|your medical history, especially of: other bladder problems (such||
1495|079|P|as blockage), high blood pressure, kidney problems, liver||
1495|080|P|problems.||
1495|081|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1495|082|P|can make you more dizzy. Do not drive, use machinery, or do||
1495|083|P|anything that needs alertness until you can do it safely. Limit||
1495|084|P|alcoholic beverages. Talk to your doctor if you are using||
1495|085|P|marijuana (cannabis).||
1495|086|P|   Before having surgery, tell your doctor or dentist about all||
1495|087|P|the products you use (including prescription drugs,||
1495|088|P|nonprescription drugs, and herbal products).||
1495|089|P|   During pregnancy, this medication should be used only when||
1495|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
1495|091|P|   It is unknown if this medication passes into breast milk.||
1495|092|P|Consult your doctor before breastfeeding.||
1495|093|B|||
1495|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1495|095|I|medications work or increase your risk for serious side effects.||
1495|096|I|This document does not contain all possible drug interactions.||
1495|097|I|Keep a list of all the products you use (including||
1495|098|I|prescription/nonprescription drugs and herbal products) and share||
1495|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
1495|100|I|the dosage of any medicines without your doctor's approval.||
1495|101|I|   This medication can slow down the removal of other medications||
1495|102|I|from your body, which may affect how they work. Examples of||
1495|103|I|affected drugs include flecainide, propafenone, thioridazine,||
1495|104|I|among others.||
1495|105|B|||
1495|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1495|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1495|108|O|poison control center right away. US residents can call||
1495|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1495|110|B|||
1495|111|N|NOTES:  Do not share this medication with others.||
1495|112|N|   Lab and/or medical tests (such as blood pressure) may be done||
1495|113|N|while you are taking this medication. Keep all medical and lab||
1495|114|N|appointments.||
1495|115|B|||
1495|116|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1495|117|D|remember. If it is more than 12 hours after the missed dose, skip||
1495|118|D|the missed dose. Take your next dose at the regular time. Do not||
1495|119|D|double the dose to catch up.||
1495|120|B|||
1495|121|R|STORAGE:  Store at room temperature away from light and moisture.||
1495|122|R|Do not store in the bathroom. Keep all medications away from||
1495|123|R|children and pets.||
1495|124|R|   Do not flush medications down the toilet or pour them into a||
1495|125|R|drain unless instructed to do so. Properly discard this product||
1495|126|R|when it is expired or no longer needed. Consult your pharmacist||
1495|127|R|or local waste disposal company.||
1495|128|B|||
1495|129|A|Information last revised August 2024.||
1495|130|A|Copyright(c) 2025 First Databank, Inc.||
1495|131|B|||
1496|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1496|002|Z|does NOT have all possible information about this product. This||
1496|003|Z|information does not assure that this product is safe, effective,||
1496|004|Z|or appropriate for you. This information is not individual||
1496|005|Z|medical advice and does not substitute for the advice of your||
1496|006|Z|health care professional. Always ask your health care||
1496|007|Z|professional for complete information about this product and your||
1496|008|Z|specific health needs.||
1496|009|B|||
1496|010|T|ACLIDINIUM POWDER INHALER - ORAL INHALATION||
1496|011|F|(A-kli-DIN-ee-um)||
1496|012|B|||
1496|013|C|COMMON BRAND NAME(S): Tudorza||
1496|014|B|||
1496|015|U|USES:  Aclidinium is used to control and prevent symptoms (such||
1496|016|U|as wheezing, shortness of breath) caused by ongoing lung disease||
1496|017|U|(chronic obstructive pulmonary disease-COPD which includes||
1496|018|U|bronchitis and emphysema). It works by relaxing the muscles||
1496|019|U|around the airways so that they open up and you can breathe more||
1496|020|U|easily. Aclidinium belongs to a class of drugs known as||
1496|021|U|anticholinergics. Controlling symptoms of breathing problems can||
1496|022|U|decrease time lost from work or school.||
1496|023|U|   This medication must be used regularly to be effective. It||
1496|024|U|does not work right away and should not be used to relieve sudden||
1496|025|U|breathing problems. If wheezing or sudden shortness of breath||
1496|026|U|occurs, use your quick-relief inhaler (such as albuterol, also||
1496|027|U|called salbutamol in some countries) as prescribed.||
1496|028|B|||
1496|029|H|HOW TO USE:  Read the Patient Information Leaflet and instruction||
1496|030|H|sheet if available from your pharmacist before you start using||
1496|031|H|aclidinium and each time you get a refill. Learn how to use this||
1496|032|H|inhaler properly. If you have any questions, ask your doctor or||
1496|033|H|pharmacist.||
1496|034|H|   Inhale this medication by mouth as directed by your doctor,||
1496|035|H|usually twice daily (every 12 hours). Do not breathe out into the||
1496|036|H|mouthpiece at any time. Avoid getting this medication into your||
1496|037|H|eyes. It may cause eye irritation and temporary blurred vision.||
1496|038|H|   If you are using other inhalers at the same time, wait at||
1496|039|H|least 1 minute between the use of each medication.||
1496|040|H|   Use this medication regularly to get the most benefit from it.||
1496|041|H|This medication works best if used at evenly spaced intervals. To||
1496|042|H|help you remember, use it at the same times each day. Do not||
1496|043|H|increase your dose, use this medication more often, or stop using||
1496|044|H|it without first consulting your doctor.||
1496|045|H|   Learn which of your inhalers you should use every day and||
1496|046|H|which you should use if your breathing suddenly worsens||
1496|047|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1496|048|H|should do if you have new or worsening cough or shortness of||
1496|049|H|breath, wheezing, increased sputum, waking up at night with||
1496|050|H|trouble breathing, if you use your quick-relief inhaler more||
1496|051|H|often, or if your quick-relief inhaler does not seem to be||
1496|052|H|working well. Learn when you can treat sudden breathing problems||
1496|053|H|by yourself and when you must get medical help right away.||
1496|054|H|   Tell your doctor if your symptoms do not get better or if they||
1496|055|H|get worse.||
1496|056|B|||
1496|057|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1496|058|S|because your doctor has judged that the benefit to you is greater||
1496|059|S|than the risk of side effects. Many people using this medication||
1496|060|S|do not have serious side effects.||
1496|061|S|   Rarely, this medication may cause severe sudden worsening of||
1496|062|S|breathing problems right after use. If you have sudden worsening||
1496|063|S|of breathing, use your quick-relief inhaler and get medical help||
1496|064|S|right away.||
1496|065|S|   Tell your doctor right away if you have any serious side||
1496|066|S|effects, including: difficult/painful urination.||
1496|067|S|   Get medical help right away if you have any very serious side||
1496|068|S|effects, including: eye pain/swelling/redness, vision changes||
1496|069|S|(such as seeing rainbows around lights at night, blurred vision).||
1496|070|S|   A very serious allergic reaction to this product is rare.||
1496|071|S|However, get medical help right away if you notice any symptoms||
1496|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1496|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1496|074|S|breathing.||
1496|075|S|   This is not a complete list of possible side effects. If you||
1496|076|S|notice other effects not listed above, contact your doctor or||
1496|077|S|pharmacist.||
1496|078|S|   In the US -||
1496|079|S|   Call your doctor for medical advice about side effects. You||
1496|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1496|081|S|www.fda.gov/medwatch.||
1496|082|S|   In Canada - Call your doctor for medical advice about side||
1496|083|S|effects. You may report side effects to Health Canada at||
1496|084|S|1-866-234-2345.||
1496|085|B|||
1496|086|P|PRECAUTIONS:  Before using aclidinium, tell your doctor or||
1496|087|P|pharmacist if you are allergic to it; or to atropine or other||
1496|088|P|belladonna-type drugs; or if you have any other allergies. This||
1496|089|P|product may contain inactive ingredients (such as milk proteins),||
1496|090|P|which can cause allergic reactions or other problems. Talk to||
1496|091|P|your pharmacist for more details.||
1496|092|P|   Before using this medication, tell your doctor or pharmacist||
1496|093|P|your medical history, especially of: personal or family history||
1496|094|P|of glaucoma (angle-closure type), difficulty urinating (for||
1496|095|P|example, due to enlarged prostate).||
1496|096|P|   Before having surgery, tell your doctor or dentist about all||
1496|097|P|the products you use (including prescription drugs,||
1496|098|P|nonprescription drugs, and herbal products).||
1496|099|P|   During pregnancy, this medication should be used only when||
1496|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
1496|101|P|   It is unknown if this medication passes into breast milk.||
1496|102|P|Consult your doctor before breastfeeding.||
1496|103|B|||
1496|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1496|105|I|medications work or increase your risk for serious side effects.||
1496|106|I|This document does not contain all possible drug interactions.||
1496|107|I|Keep a list of all the products you use (including||
1496|108|I|prescription/nonprescription drugs and herbal products) and share||
1496|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
1496|110|I|the dosage of any medicines without your doctor's approval.||
1496|111|B|||
1496|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1496|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1496|114|O|poison control center right away. US residents can call||
1496|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1496|116|B|||
1496|117|N|NOTES:  Do not share this medication with others.||
1496|118|B|||
1496|119|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1496|120|D|next dose at the regular time. Do not double the dose to catch||
1496|121|D|up.||
1496|122|B|||
1496|123|R|STORAGE:  Store at room temperature away from moisture. Do not||
1496|124|R|store in the bathroom. Keep new inhalers in the sealed pouch||
1496|125|R|until you are ready to use them. The inhaler should be discarded||
1496|126|R|when the dose indicator shows "0", when the inhaler becomes||
1496|127|R|locked, or 45 days after removing the inhaler from the sealed||
1496|128|R|pouch, whichever comes first. Keep all medications away from||
1496|129|R|children and pets.||
1496|130|R|   Do not flush medications down the toilet or pour them into a||
1496|131|R|drain unless instructed to do so. Properly discard this product||
1496|132|R|when it is expired or no longer needed. Consult your pharmacist||
1496|133|R|or local waste disposal company.||
1496|134|B|||
1496|135|M|MEDICAL ALERT:  Your condition can cause complications in a||
1496|136|M|medical emergency. For information about enrolling in MedicAlert,||
1496|137|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1496|138|B|||
1496|139|A|Information last revised October 2024.||
1496|140|A|Copyright(c) 2025 First Databank, Inc.||
1496|141|B|||
1497|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1497|002|Z|does NOT have all possible information about this product. This||
1497|003|Z|information does not assure that this product is safe, effective,||
1497|004|Z|or appropriate for you. This information is not individual||
1497|005|Z|medical advice and does not substitute for the advice of your||
1497|006|Z|health care professional. Always ask your health care||
1497|007|Z|professional for complete information about this product and your||
1497|008|Z|specific health needs.||
1497|009|B|||
1497|010|T|IRON/VITAMIN B12/FOLIC ACID - ORAL||
1497|011|B|||
1497|012|W|WARNING:  Accidental overdose of iron-containing products is a||
1497|013|W|leading cause of fatal poisoning in children under 6 years. Keep||
1497|014|W|this product out of reach of children. If overdose does occur,||
1497|015|W|get medical help right away or call a poison control center.||
1497|016|B|||
1497|017|U|USES:  This combination product contains a mineral (iron) along||
1497|018|U|with 2 vitamins (vitamin B12 and folic acid). It is used to treat||
1497|019|U|or prevent a lack of these nutrients which may occur due to||
1497|020|U|certain health conditions (such as anemia, pregnancy, poor diet,||
1497|021|U|surgery recovery). Iron is an important mineral that the body||
1497|022|U|needs to produce red blood cells. Vitamin B12 is important for||
1497|023|U|normal blood, cells, and nerves. Folic acid is needed to form||
1497|024|U|healthy cells, especially red blood cells.||
1497|025|U|   Women of childbearing age must get enough folic acid, either||
1497|026|U|through diet or supplements, to prevent spinal cord birth defects||
1497|027|U|in an unborn baby if they become pregnant.||
1497|028|B|||
1497|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
1497|030|H|doctor, usually once daily.||
1497|031|H|   This medication is best taken on an empty stomach 1 hour||
1497|032|H|before or 2 hours after meals. If stomach upset occurs, you may||
1497|033|H|take this medication with food. Avoid taking antacids, dairy||
1497|034|H|products, tea, or coffee within 2 hours before or after this||
1497|035|H|medication because they will decrease its effectiveness.||
1497|036|H|   Take with a full glass of water (8 ounces/240 milliliters)||
1497|037|H|unless your doctor directs you otherwise. Do not lie down for at||
1497|038|H|least 10 minutes after taking this medication.||
1497|039|H|   Take this medication regularly to get the most benefit from||
1497|040|H|it. To help you remember, take it at the same time each day.||
1497|041|B|||
1497|042|S|SIDE EFFECTS:  Constipation, diarrhea, and upset stomach may||
1497|043|S|occur. If any of these effects last or get worse, tell your||
1497|044|S|doctor or pharmacist promptly.||
1497|045|S|   Iron may cause your stools to turn black, which is not||
1497|046|S|harmful.||
1497|047|S|   Remember that this medication has been prescribed because your||
1497|048|S|doctor has judged that the benefit to you is greater than the||
1497|049|S|risk of side effects. Many people using this medication do not||
1497|050|S|have serious side effects.||
1497|051|S|   A very serious allergic reaction to this drug is rare.||
1497|052|S|However, get medical help right away if you notice any symptoms||
1497|053|S|of a serious allergic reaction, including: rash, itching/swelling||
1497|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1497|055|S|breathing.||
1497|056|S|   This is not a complete list of possible side effects. If you||
1497|057|S|notice other effects not listed above, contact your doctor or||
1497|058|S|pharmacist.||
1497|059|S|   In the US -||
1497|060|S|   Call your doctor for medical advice about side effects. You||
1497|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1497|062|S|www.fda.gov/medwatch.||
1497|063|S|   In Canada - Call your doctor for medical advice about side||
1497|064|S|effects. You may report side effects to Health Canada at||
1497|065|S|1-866-234-2345.||
1497|066|B|||
1497|067|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1497|068|P|pharmacist if you are allergic to any of its ingredients; or if||
1497|069|P|you have any other allergies. This product may contain inactive||
1497|070|P|ingredients, which can cause allergic reactions or other||
1497|071|P|problems. Talk to your pharmacist for more details.||
1497|072|P|   Before using this medication, tell your doctor or pharmacist||
1497|073|P|your medical history, especially of: certain metabolic disorders||
1497|074|P|(such as hemochromatosis, hemosiderosis), use/abuse of alcohol,||
1497|075|P|stomach/intestinal problems (such as ulcers, colitis), vitamin||
1497|076|P|B12 deficiency (pernicious anemia).||
1497|077|P|   Folic acid may falsely improve certain lab tests for vitamin||
1497|078|P|B12 deficiency without actually treating this anemia. Untreated||
1497|079|P|vitamin B12 deficiency may cause serious nerve problems||
1497|080|P|(including peripheral neuropathy symptoms such as||
1497|081|P|numbness/pain/tingling sensations). Consult your doctor or||
1497|082|P|pharmacist for more details.||
1497|083|P|   Before having surgery, tell your doctor or dentist about all||
1497|084|P|the products you use (including prescription drugs,||
1497|085|P|nonprescription drugs, and herbal products).||
1497|086|P|   During pregnancy, this medication should be used only when||
1497|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
1497|088|P|   This medication passes into breast milk. Consult your doctor||
1497|089|P|before breastfeeding.||
1497|090|B|||
1497|091|I|DRUG INTERACTIONS:  See also How To Use section.||
1497|092|I|   Drug interactions may change how your medications work or||
1497|093|I|increase your risk for serious side effects. This document does||
1497|094|I|not contain all possible drug interactions. Keep a list of all||
1497|095|I|the products you use (including prescription/nonprescription||
1497|096|I|drugs and herbal products) and share it with your doctor and||
1497|097|I|pharmacist. Do not start, stop, or change the dosage of any||
1497|098|I|medicines without your doctor's approval.||
1497|099|I|   This product can decrease the absorption of certain drugs,||
1497|100|I|especially if you take them around the same time. These drugs||
1497|101|I|include bisphosphonates (such as alendronate), levodopa,||
1497|102|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
1497|103|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
1497|104|I|minocycline), thyroid medications (such as levothyroxine), among||
1497|105|I|others. Ask your doctor or pharmacist how long you should wait||
1497|106|I|between doses of this product and your other medications and to||
1497|107|I|find a dosing schedule that works for all your medications.||
1497|108|I|   This product may interfere with certain lab tests (such as||
1497|109|I|tests for blood in the stools), possibly causing false test||
1497|110|I|results. Make sure lab personnel and all your doctors know you||
1497|111|I|use this product.||
1497|112|B|||
1497|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1497|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1497|115|O|poison control center right away. US residents can call||
1497|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1497|117|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
1497|118|O|diarrhea.||
1497|119|B|||
1497|120|N|NOTES:  Do not share this medication with others.||
1497|121|N|   Lab and/or medical tests (such as complete blood count,||
1497|122|N|vitamin B12 levels) may be done while you are taking this||
1497|123|N|product. Keep all medical and lab appointments. Consult your||
1497|124|N|doctor for more details.||
1497|125|N|   There are many iron supplement products available, both with||
1497|126|N|and without a prescription. Some brands also contain ingredients||
1497|127|N|(such as succinic acid) that might help your body absorb more||
1497|128|N|iron or decrease side effects. Consult your doctor or pharmacist||
1497|129|N|if you have questions about available iron supplements or their||
1497|130|N|ingredients.||
1497|131|N|   This medication is not a substitute for a proper diet. It is||
1497|132|N|important to eat a well-balanced diet. Foods rich in iron include||
1497|133|N|beans, nuts, asparagus, oatmeal, red meat, dried peaches, and||
1497|134|N|pork liver. B vitamins (including folic acid) are naturally found||
1497|135|N|in leafy greens and other vegetables, meat, fish, poultry, and||
1497|136|N|enriched breads/cereals.||
1497|137|B|||
1497|138|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1497|139|D|remember. If it is near the time of the next dose, skip the||
1497|140|D|missed dose. Take your next dose at the regular time. Do not||
1497|141|D|double the dose to catch up.||
1497|142|B|||
1497|143|R|STORAGE:  Different brands of this medication have different||
1497|144|R|storage needs. Check the product package for instructions on how||
1497|145|R|to store your brand, or ask your pharmacist. Do not store in the||
1497|146|R|bathroom. Keep all medications away from children and pets.||
1497|147|R|   Do not flush medications down the toilet or pour them into a||
1497|148|R|drain unless instructed to do so. Properly discard this product||
1497|149|R|when it is expired or no longer needed. Consult your pharmacist||
1497|150|R|or local waste disposal company.||
1497|151|B|||
1497|152|A|Information last revised October 2025.||
1497|153|A|Copyright(c) 2025 First Databank, Inc.||
1497|154|B|||
1498|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1498|002|Z|does NOT have all possible information about this product. This||
1498|003|Z|information does not assure that this product is safe, effective,||
1498|004|Z|or appropriate for you. This information is not individual||
1498|005|Z|medical advice and does not substitute for the advice of your||
1498|006|Z|health care professional. Always ask your health care||
1498|007|Z|professional for complete information about this product and your||
1498|008|Z|specific health needs.||
1498|009|B|||
1498|010|T|PREDNISONE DELAYED-RELEASE - ORAL||
1498|011|F|(PRED-ni-sone)||
1498|012|B|||
1498|013|C|COMMON BRAND NAME(S): Rayos||
1498|014|B|||
1498|015|U|USES:  Prednisone is used to treat conditions such as arthritis,||
1498|016|U|blood disorders, breathing problems, severe allergies, skin||
1498|017|U|diseases, cancer, eye problems, and immune system disorders.||
1498|018|U|Prednisone belongs to a class of drugs known as corticosteroids.||
1498|019|U|It changes how your body responds to different medical conditions||
1498|020|U|to lessen symptoms such as swelling and allergic-type reactions.||
1498|021|B|||
1498|022|V|OTHER USES:  This section contains uses of this drug that are not||
1498|023|V|listed in the approved professional labeling for the drug but||
1498|024|V|that may be prescribed by your health care professional. Use this||
1498|025|V|drug for a condition that is listed in this section only if it||
1498|026|V|has been so prescribed by your health care professional.||
1498|027|V|   Prednisone may also be used for COVID-19, but is only||
1498|028|V|effective in hospitalized patients who need supplemental oxygen||
1498|029|V|or a mechanical ventilator to breathe.||
1498|030|B|||
1498|031|H|HOW TO USE:  Take this medication by mouth as directed by your||
1498|032|H|doctor, usually once daily. To prevent stomach upset, take this||
1498|033|H|medication with food and a full glass of water (8 ounces/240||
1498|034|H|milliliters) unless your doctor directs you otherwise.||
1498|035|H|   Swallow this medication whole. Do not crush, chew, or break||
1498|036|H|the tablet. Doing so can release all of the drug at once,||
1498|037|H|increasing the risk of side effects.||
1498|038|H|   Carefully follow the dosing schedule prescribed by your||
1498|039|H|doctor. The dosage and length of treatment are based on your||
1498|040|H|medical condition and response to treatment. Use this medication||
1498|041|H|regularly to get the most benefit from it. To help you remember,||
1498|042|H|take it at the same time each day. If you are taking this||
1498|043|H|medication on a different schedule than a daily one (such as||
1498|044|H|every other day), it may help to mark your calendar with a||
1498|045|H|reminder.||
1498|046|H|   Do not stop taking this medication without consulting your||
1498|047|H|doctor. Some conditions may become worse when this drug is||
1498|048|H|suddenly stopped. Also, you may experience symptoms such as||
1498|049|H|weakness, weight loss, nausea, muscle pain, headache, tiredness,||
1498|050|H|dizziness. To prevent these symptoms while you are stopping||
1498|051|H|treatment with this drug, your doctor may reduce your dose||
1498|052|H|gradually. Consult your doctor or pharmacist for more details.||
1498|053|H|Report any new or worsening symptoms right away.||
1498|054|H|   Tell your doctor if your condition lasts or gets worse.||
1498|055|B|||
1498|056|S|SIDE EFFECTS:  Nausea, vomiting, heartburn, increased appetite,||
1498|057|S|weight gain, or acne may occur. If any of these effects last or||
1498|058|S|get worse, tell your doctor or pharmacist promptly.||
1498|059|S|   Remember that this medication has been prescribed because your||
1498|060|S|doctor has judged that the benefit to you is greater than the||
1498|061|S|risk of side effects. Many people using this medication do not||
1498|062|S|have serious side effects.||
1498|063|S|   Tell your doctor right away if you have any serious side||
1498|064|S|effects, including: bone pain, easy bruising/bleeding, menstrual||
1498|065|S|period changes, mental/mood changes (such as depression, mood||
1498|066|S|swings, agitation), puffy face, slow wound healing, swelling||
1498|067|S|hands/ankles/feet, thinning skin, unusual weight gain, vision||
1498|068|S|problems (such as blurred vision), weakness, symptoms of||
1498|069|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
1498|070|S|black/tarry stools, vomit that looks like coffee grounds),||
1498|071|S|red/purple spots on the skin.||
1498|072|S|   This medication may rarely make your blood sugar rise, which||
1498|073|S|can cause or worsen diabetes. Tell your doctor right away if you||
1498|074|S|have symptoms of high blood sugar such as increased||
1498|075|S|thirst/urination. If you already have diabetes, check your blood||
1498|076|S|sugar regularly as directed and share the results with your||
1498|077|S|doctor. Your doctor may need to adjust your diabetes medication,||
1498|078|S|exercise program, or diet.||
1498|079|S|   A very serious allergic reaction to this drug is rare.||
1498|080|S|However, get medical help right away if you notice any symptoms||
1498|081|S|of a serious allergic reaction, including: rash, itching/swelling||
1498|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1498|083|S|breathing.||
1498|084|S|   This is not a complete list of possible side effects. If you||
1498|085|S|notice other effects not listed above, contact your doctor or||
1498|086|S|pharmacist.||
1498|087|S|   In the US -||
1498|088|S|   Call your doctor for medical advice about side effects. You||
1498|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1498|090|S|www.fda.gov/medwatch.||
1498|091|S|   In Canada - Call your doctor for medical advice about side||
1498|092|S|effects. You may report side effects to Health Canada at||
1498|093|S|1-866-234-2345.||
1498|094|B|||
1498|095|P|PRECAUTIONS:  Before taking prednisone, tell your doctor or||
1498|096|P|pharmacist if you are allergic to it; or if you have any other||
1498|097|P|allergies. This product may contain inactive ingredients, which||
1498|098|P|can cause allergic reactions or other problems. Talk to your||
1498|099|P|pharmacist for more details.||
1498|100|P|   Before using this medication, tell your doctor or pharmacist||
1498|101|P|your medical history, especially of: bone loss (osteoporosis),||
1498|102|P|current/past infections (such as fungal infections, tuberculosis,||
1498|103|P|herpes), diabetes, eye problems (such as cataracts, glaucoma),||
1498|104|P|heart problems (such as heart failure, recent heart attack), high||
1498|105|P|blood pressure, kidney disease, liver disease (such as hepatitis||
1498|106|P|B), mental/mood disorders (such as psychosis, anxiety,||
1498|107|P|depression), stomach/intestinal problems (such as ulcer,||
1498|108|P|diverticulitis), thyroid problems, a certain adrenal gland tumor||
1498|109|P|(pheochromocytoma).||
1498|110|P|   Using corticosteroid medications for a long time can make it||
1498|111|P|more difficult for your body to respond to physical stress.||
1498|112|P|Before having surgery or emergency treatment, or if you get a||
1498|113|P|serious illness/injury, tell your doctor or dentist that you are||
1498|114|P|using this medication or have used this medication within the||
1498|115|P|past 12 months. Tell your doctor right away if you develop||
1498|116|P|unusual/extreme tiredness or weight loss. If you will be using||
1498|117|P|this medication for a long time, carry a warning card or medical||
1498|118|P|ID bracelet that identifies your use of this medication.||
1498|119|P|   Before having surgery, tell your doctor or dentist about all||
1498|120|P|the products you use (including prescription drugs,||
1498|121|P|nonprescription drugs, and herbal products).||
1498|122|P|   This medication may mask signs of infection. It can make you||
1498|123|P|more likely to get infections or may make current infections||
1498|124|P|worse. Stay away from anyone who has an infection that may easily||
1498|125|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1498|126|P|doctor if you have been exposed to an infection or for more||
1498|127|P|details.||
1498|128|P|   Tell your health care professional that you are using||
1498|129|P|prednisone before having any immunizations/vaccinations. Avoid||
1498|130|P|contact with people who have recently received live vaccines||
1498|131|P|(such as flu vaccine inhaled through the nose).||
1498|132|P|   Older adults may be more sensitive to the side effects of this||
1498|133|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
1498|134|P|mental/mood changes (such as confusion).||
1498|135|P|   This medication may slow down a child's growth if used for a||
1498|136|P|long time. Consult the doctor or pharmacist for more details. See||
1498|137|P|the doctor regularly so your child's height and growth can be||
1498|138|P|checked.||
1498|139|P|   During pregnancy, this medication should be used only when||
1498|140|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
1498|141|P|risks and benefits with your doctor. Infants born to mothers who||
1498|142|P|have been using this medication for an extended period of time||
1498|143|P|may have hormone problems. Tell your doctor right away if you||
1498|144|P|notice symptoms such as nausea/vomiting that doesn't stop, severe||
1498|145|P|diarrhea, or weakness in your newborn.||
1498|146|P|   This medication passes into breast milk but is unlikely to||
1498|147|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1498|148|B|||
1498|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1498|150|I|medications work or increase your risk for serious side effects.||
1498|151|I|This document does not contain all possible drug interactions.||
1498|152|I|Keep a list of all the products you use (including||
1498|153|I|prescription/nonprescription drugs and herbal products) and share||
1498|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
1498|155|I|the dosage of any medicines without your doctor's approval.||
1498|156|I|   Some products that may interact with this drug include:||
1498|157|I|aldesleukin, desmopressin, mifepristone, drugs that can cause||
1498|158|I|bleeding/bruising (including antiplatelet drugs such as||
1498|159|I|clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs||
1498|160|I|such as aspirin/celecoxib/ibuprofen).||
1498|161|I|   If your doctor has told you to take low-dose aspirin to||
1498|162|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
1498|163|I|you should keep taking the aspirin unless your doctor tells you||
1498|164|I|not to. Ask your doctor or pharmacist for more details.||
1498|165|I|   This medication may interfere with certain lab tests (such as||
1498|166|I|allergy skin tests), possibly causing false test results. Make||
1498|167|I|sure lab personnel and all your doctors know you use this drug.||
1498|168|B|||
1498|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1498|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1498|171|O|poison control center right away. US residents can call||
1498|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1498|173|B|||
1498|174|N|NOTES:  Do not share this medication with others.||
1498|175|N|   Lab and/or medical tests (such as blood pressure, blood sugar,||
1498|176|N|complete blood count, mineral blood levels, height/weight||
1498|177|N|measurements, bone density tests, eye exams) may be done while||
1498|178|N|you are taking this medication. Keep all medical and lab||
1498|179|N|appointments. Consult your doctor for more details.||
1498|180|N|   This medication may cause bone loss (osteoporosis) when used||
1498|181|N|for a long time. Lifestyle changes that may help reduce the risk||
1498|182|N|of bone problems include doing weight-bearing exercise, stopping||
1498|183|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
1498|184|N|D. Talk to your doctor for more details.||
1498|185|B|||
1498|186|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1498|187|D|remember. If it is near the time of the next dose, skip the||
1498|188|D|missed dose. Take your next dose at the regular time. Do not||
1498|189|D|double the dose to catch up.||
1498|190|D|   If you are taking this medication on a different schedule than||
1498|191|D|a daily one (such as every other day), ask your doctor ahead of||
1498|192|D|time about what you should do if you miss a dose.||
1498|193|B|||
1498|194|R|STORAGE:  Store at room temperature away from light and moisture.||
1498|195|R|Do not store in the bathroom. Keep all medications away from||
1498|196|R|children and pets.||
1498|197|R|   Do not flush medications down the toilet or pour them into a||
1498|198|R|drain unless instructed to do so. Properly discard this product||
1498|199|R|when it is expired or no longer needed. Consult your pharmacist||
1498|200|R|or local waste disposal company.||
1498|201|B|||
1498|202|M|MEDICAL ALERT:  Your condition can cause complications in a||
1498|203|M|medical emergency. For information about enrolling in MedicAlert,||
1498|204|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1498|205|B|||
1498|206|A|Information last revised September 2025.||
1498|207|A|Copyright(c) 2025 First Databank, Inc.||
1498|208|B|||
1499|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1499|002|Z|does NOT have all possible information about this product. This||
1499|003|Z|information does not assure that this product is safe, effective,||
1499|004|Z|or appropriate for you. This information is not individual||
1499|005|Z|medical advice and does not substitute for the advice of your||
1499|006|Z|health care professional. Always ask your health care||
1499|007|Z|professional for complete information about this product and your||
1499|008|Z|specific health needs.||
1499|009|B|||
1499|010|T|BOSUTINIB - ORAL||
1499|011|F|(boe-SUE-ti-nib)||
1499|012|B|||
1499|013|C|COMMON BRAND NAME(S): Bosulif||
1499|014|B|||
1499|015|U|USES:  Bosutinib is used to treat a certain type of blood cancer||
1499|016|U|(chronic myelogenous leukemia-CML). It works by slowing or||
1499|017|U|stopping the growth of cancer cells.||
1499|018|B|||
1499|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1499|020|H|from your pharmacist before you start taking bosutinib and each||
1499|021|H|time you get a refill. If you have any questions, ask your doctor||
1499|022|H|or pharmacist.||
1499|023|H|   Take this medication by mouth with food as directed by your||
1499|024|H|doctor, usually once daily. Swallow the tablets whole. Do not||
1499|025|H|crush, break, chew, or cut the tablets. Avoid handling or||
1499|026|H|touching crushed or broken tablets.||
1499|027|H|   If you are taking the capsule form of this medication, swallow||
1499|028|H|the capsules whole. If you have trouble swallowing the capsule,||
1499|029|H|read the Instructions for Use to learn how to prepare a dose by||
1499|030|H|opening the capsule(s) and mixing the contents with room||
1499|031|H|temperature applesauce or yogurt. Swallow all of the mixture||
1499|032|H|right away without chewing. Do not prepare a supply in advance.||
1499|033|H|   The dosage is based on your medical condition and response to||
1499|034|H|treatment. Children's dosage is also based on body size. Do not||
1499|035|H|increase your dose or use this drug more often or for longer than||
1499|036|H|prescribed. Your condition will not improve any faster, and your||
1499|037|H|risk of serious side effects will increase.||
1499|038|H|   Use this medication regularly to get the most benefit from it.||
1499|039|H|Remember to use it at the same time each day||
1499|040|H|   Medications that reduce stomach acid (such as antacids, proton||
1499|041|H|pump inhibitors/PPIs, H2 blockers) may make bosutinib work less||
1499|042|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
1499|043|H|using this medication. If you take antacids or H2 blockers (such||
1499|044|H|as famotidine, nizatidine), take these medications at least 2||
1499|045|H|hours before or 2 hours after bosutinib.||
1499|046|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1499|047|H|using this medication unless your doctor or pharmacist says you||
1499|048|H|may do so safely. Grapefruit can increase the chance of side||
1499|049|H|effects with this medicine. Ask your doctor or pharmacist for||
1499|050|H|more details.||
1499|051|H|   Since this drug can be absorbed through the skin and lungs and||
1499|052|H|may harm an unborn baby, women who are pregnant or who may become||
1499|053|H|pregnant should not handle this medication or breathe the dust||
1499|054|H|from the tablets or capsules.||
1499|055|B|||
1499|056|S|SIDE EFFECTS:  Nausea, vomiting, stomach/abdominal pain, loss of||
1499|057|S|appetite, cough, joint pain, headache, or dizziness may occur. If||
1499|058|S|any of these effects last or get worse, tell your doctor or||
1499|059|S|pharmacist promptly.||
1499|060|S|   Diarrhea is a common side effect. Drink plenty of fluids as||
1499|061|S|directed by your doctor to reduce your risk of dehydration. Your||
1499|062|S|doctor may prescribe anti-diarrhea medication (such as||
1499|063|S|loperamide) to control your symptoms. Tell your doctor right away||
1499|064|S|if you develop diarrhea that is severe or doesn't stop, signs of||
1499|065|S|dehydration (such as extreme thirst, dizziness, decreased||
1499|066|S|urination).||
1499|067|S|   People using this medication may have serious side effects.||
1499|068|S|However, you have been prescribed this drug because your doctor||
1499|069|S|has judged that the benefit to you is greater than the risk of||
1499|070|S|side effects. Careful monitoring by your doctor may decrease your||
1499|071|S|risk.||
1499|072|S|   This medication decreases bone marrow function, an effect that||
1499|073|S|may lead to a low number of blood cells such as red cells, white||
1499|074|S|cells, and platelets. This effect can cause anemia, decrease your||
1499|075|S|body's ability to fight an infection, or cause easy||
1499|076|S|bruising/bleeding. Tell your doctor right away if you develop any||
1499|077|S|of the following unlikely symptoms: unusual tiredness, pale skin,||
1499|078|S|signs of infection (such as sore throat that doesn't go away,||
1499|079|S|fever, chills), easy bleeding/bruising.||
1499|080|S|   Tell your doctor right away if you have any serious side||
1499|081|S|effects, including: severe stomach/abdominal pain, yellowing||
1499|082|S|eyes/skin, dark urine, swelling hands/ankles/feet, sudden weight||
1499|083|S|gain, signs of kidney problems (such as change in the amount of||
1499|084|S|urine).||
1499|085|S|   Get medical help right away if you have any very serious side||
1499|086|S|effects, including: chest pain, shortness of breath.||
1499|087|S|   A very serious allergic reaction to this drug is rare.||
1499|088|S|However, get medical help right away if you notice any symptoms||
1499|089|S|of a serious allergic reaction, including: rash, itching/swelling||
1499|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1499|091|S|breathing.||
1499|092|S|   Bosutinib can commonly cause a mild rash that is usually not||
1499|093|S|serious. However, you may not be able to tell it apart from a||
1499|094|S|rare rash that could be a sign of a severe allergic reaction. Get||
1499|095|S|medical help right away if you develop any rash.||
1499|096|S|   This is not a complete list of possible side effects. If you||
1499|097|S|notice other effects not listed above, contact your doctor or||
1499|098|S|pharmacist.||
1499|099|S|   In the US -||
1499|100|S|   Call your doctor for medical advice about side effects. You||
1499|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1499|102|S|www.fda.gov/medwatch.||
1499|103|S|   In Canada - Call your doctor for medical advice about side||
1499|104|S|effects. You may report side effects to Health Canada at||
1499|105|S|1-866-234-2345.||
1499|106|B|||
1499|107|P|PRECAUTIONS:  Before taking bosutinib, tell your doctor or||
1499|108|P|pharmacist if you are allergic to it; or if you have any other||
1499|109|P|allergies. This product may contain inactive ingredients, which||
1499|110|P|can cause allergic reactions or other problems. Talk to your||
1499|111|P|pharmacist for more details.||
1499|112|P|   Before using this medication, tell your doctor or pharmacist||
1499|113|P|your medical history, especially of: liver disease, kidney||
1499|114|P|disease.||
1499|115|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1499|116|P|can make you more dizzy. Do not drive, use machinery, or do||
1499|117|P|anything that needs alertness until you can do it safely. Avoid||
1499|118|P|alcoholic beverages. Talk to your doctor if you are using||
1499|119|P|marijuana (cannabis). Alcohol may also increase the risk of||
1499|120|P|serious liver problems.||
1499|121|P|   Before having surgery, tell your doctor or dentist about all||
1499|122|P|the products you use (including prescription drugs,||
1499|123|P|nonprescription drugs, and herbal products).||
1499|124|P|   Tell your health care professional that you are using||
1499|125|P|bosutinib before having any immunizations/vaccinations. Avoid||
1499|126|P|contact with people who have recently received live vaccines||
1499|127|P|(such as flu vaccine inhaled through the nose).||
1499|128|P|   To lower the chance of getting cut, bruised, or injured, use||
1499|129|P|caution with sharp objects like razors and nail cutters, and||
1499|130|P|avoid activities such as contact sports.||
1499|131|P|   Since this drug can be absorbed through the skin and lungs and||
1499|132|P|may harm an unborn baby, women who are pregnant or who may become||
1499|133|P|pregnant should not handle this medication or breathe the dust||
1499|134|P|from the tablets or capsules.||
1499|135|P|   Tell your doctor if you are pregnant or plan to become||
1499|136|P|pregnant. You should not become pregnant while using bosutinib.||
1499|137|P|Bosutinib may harm an unborn baby. Your doctor should order a||
1499|138|P|pregnancy test before you start this medication. Ask about||
1499|139|P|reliable forms of birth control while using this medication and||
1499|140|P|for some time after the last dose. If you become pregnant, talk||
1499|141|P|to your doctor right away about the risks and benefits of this||
1499|142|P|medication.||
1499|143|P|   It is unknown if this medication passes into breast milk.||
1499|144|P|Because of the possible risk to the infant, breastfeeding is not||
1499|145|P|recommended while using this medication and for some time after||
1499|146|P|the last dose. Consult your doctor before breastfeeding.||
1499|147|B|||
1499|148|I|DRUG INTERACTIONS:  See also How to Use section.||
1499|149|I|   Drug interactions may change how your medications work or||
1499|150|I|increase your risk for serious side effects. This document does||
1499|151|I|not contain all possible drug interactions. Keep a list of all||
1499|152|I|the products you use (including prescription/nonprescription||
1499|153|I|drugs and herbal products) and share it with your doctor and||
1499|154|I|pharmacist. Do not start, stop, or change the dosage of any||
1499|155|I|medicines without your doctor's approval.||
1499|156|I|   Other medications can affect the removal of bosutinib from||
1499|157|I|your body, which may affect how bosutinib works. Examples include||
1499|158|I|azole antifungals (such as ketoconazole, itraconazole), macrolide||
1499|159|I|antibiotics (such as clarithromycin), nefazodone, HIV protease||
1499|160|I|inhibitors (such as nelfinavir), rifamycins (such as rifabutin),||
1499|161|I|ritonavir, St. John's wort, drugs used to treat seizures (such as||
1499|162|I|carbamazepine, phenytoin), telithromycin, among others.||
1499|163|B|||
1499|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1499|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1499|166|O|poison control center right away. US residents can call||
1499|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1499|168|B|||
1499|169|N|NOTES:  Do not share this medication with others.||
1499|170|N|   Lab and/or medical tests (such as kidney/liver function,||
1499|171|N|complete blood count) should be done while you are taking this||
1499|172|N|medication. Keep all medical and lab appointments. Consult your||
1499|173|N|doctor for more details.||
1499|174|B|||
1499|175|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1499|176|D|remember. If it is more than 12 hours after the missed dose, skip||
1499|177|D|the missed dose. Take your next dose at the regular time. Do not||
1499|178|D|double the dose to catch up.||
1499|179|B|||
1499|180|R|STORAGE:  Store in the original container at room temperature||
1499|181|R|away from light and moisture. Do not store in the bathroom. Keep||
1499|182|R|the drying agent (desiccant) in the bottle if you are using the||
1499|183|R|tablet form of this medication. Tightly close the bottle when not||
1499|184|R|in use. Keep all medications away from children and pets.||
1499|185|R|   Do not flush medications down the toilet or pour them into a||
1499|186|R|drain unless instructed to do so. Properly discard this product||
1499|187|R|when it is expired or no longer needed. Consult your pharmacist||
1499|188|R|or local waste disposal company.||
1499|189|B|||
1499|190|M|MEDICAL ALERT:  Your condition can cause complications in a||
1499|191|M|medical emergency. For information about enrolling in MedicAlert,||
1499|192|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1499|193|B|||
1499|194|A|Information last revised September 2025.||
1499|195|A|Copyright(c) 2025 First Databank, Inc.||
1499|196|B|||
1500|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1500|002|Z|does NOT have all possible information about this product. This||
1500|003|Z|information does not assure that this product is safe, effective,||
1500|004|Z|or appropriate for you. This information is not individual||
1500|005|Z|medical advice and does not substitute for the advice of your||
1500|006|Z|health care professional. Always ask your health care||
1500|007|Z|professional for complete information about this product and your||
1500|008|Z|specific health needs.||
1500|009|B|||
1500|010|T|ENZALUTAMIDE - ORAL||
1500|011|F|(EN-za-LOO-ta-mide)||
1500|012|B|||
1500|013|C|COMMON BRAND NAME(S): Xtandi||
1500|014|B|||
1500|015|U|USES:  Enzalutamide is used to treat prostate cancer. This||
1500|016|U|medication belongs to a class of drugs known as anti-androgens||
1500|017|U|(anti-testosterone). It works by blocking the effects of||
1500|018|U|testosterone to slow the growth and spread of prostate cancer.||
1500|019|B|||
1500|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1500|021|H|from your pharmacist before you start taking enzalutamide and||
1500|022|H|each time you get a refill. If you have any questions, ask your||
1500|023|H|doctor or pharmacist.||
1500|024|H|   Take this medication by mouth with or without food as directed||
1500|025|H|by your doctor, usually once daily. Swallow the capsules or||
1500|026|H|tablets whole with enough water to make sure that you can||
1500|027|H|completely swallow the medication. If you have trouble swallowing||
1500|028|H|the capsules or tablets whole, ask your doctor if you can be||
1500|029|H|switched to a smaller tablet size. Do not chew, dissolve, or open||
1500|030|H|the capsules. Do not cut, crush, or chew the tablets.||
1500|031|H|   The dosage is based on your medical condition, response to||
1500|032|H|treatment, and other medications you may be taking. Be sure to||
1500|033|H|tell your doctor and pharmacist about all the products you use||
1500|034|H|(including prescription drugs, nonprescription drugs, and herbal||
1500|035|H|products).||
1500|036|H|   Do not increase your dose or take this drug more often than||
1500|037|H|prescribed. Your condition will not improve any faster, and your||
1500|038|H|risk of side effects will increase.||
1500|039|H|   Take this medication regularly to get the most benefit from||
1500|040|H|it. To help you remember, take it at the same time each day.||
1500|041|H|   Since this drug can be absorbed through the skin and lungs and||
1500|042|H|may harm an unborn baby, women who are pregnant or who may become||
1500|043|H|pregnant should not handle this medication or breathe the dust||
1500|044|H|from the capsules or tablets.||
1500|045|B|||
1500|046|S|SIDE EFFECTS:  Hot flashes, headache, dizziness, or decreased||
1500|047|S|sexual interest/ability may occur. If any of these effects last||
1500|048|S|or get worse, tell your doctor or pharmacist promptly.||
1500|049|S|   Remember that this medication has been prescribed because your||
1500|050|S|doctor has judged that the benefit to you is greater than the||
1500|051|S|risk of side effects. Many people using this medication do not||
1500|052|S|have serious side effects.||
1500|053|S|   Tell your doctor right away if you have any serious side||
1500|054|S|effects, including: back pain, numbness/tingling/weakness/pain of||
1500|055|S|the arms or legs, falls, broken bones, pink/red urine.||
1500|056|S|   This medication may raise your blood pressure. Check your||
1500|057|S|blood pressure regularly and tell your doctor if the results are||
1500|058|S|high.||
1500|059|S|   Get medical help right away if you have any very serious side||
1500|060|S|effects, including: headache that doesn't go away, decreased||
1500|061|S|alertness, seizure, sudden vision changes, mental/mood changes||
1500|062|S|(such as memory problems, confusion), signs of a heart attack||
1500|063|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
1500|064|S|sweating).||
1500|065|S|   This medication may lower your ability to fight infections.||
1500|066|S|This may make you more likely to get a serious (rarely fatal)||
1500|067|S|infection or make any infection you have worse. Tell your doctor||
1500|068|S|right away if you have any signs of infection (such as sore||
1500|069|S|throat that doesn't go away, fever, chills).||
1500|070|S|   A very serious allergic reaction to this drug is rare.||
1500|071|S|However, get medical help right away if you notice any symptoms||
1500|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1500|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1500|074|S|breathing.||
1500|075|S|   This is not a complete list of possible side effects. If you||
1500|076|S|notice other effects not listed above, contact your doctor or||
1500|077|S|pharmacist.||
1500|078|S|   In the US -||
1500|079|S|   Call your doctor for medical advice about side effects. You||
1500|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1500|081|S|www.fda.gov/medwatch.||
1500|082|S|   In Canada - Call your doctor for medical advice about side||
1500|083|S|effects. You may report side effects to Health Canada at||
1500|084|S|1-866-234-2345.||
1500|085|B|||
1500|086|P|PRECAUTIONS:  Before taking enzalutamide, tell your doctor or||
1500|087|P|pharmacist if you are allergic to it; or if you have any other||
1500|088|P|allergies. This product may contain inactive ingredients, which||
1500|089|P|can cause allergic reactions or other problems. Talk to your||
1500|090|P|pharmacist for more details.||
1500|091|P|   Before using this medication, tell your doctor or pharmacist||
1500|092|P|your medical history, especially of: high blood pressure,||
1500|093|P|seizures, risk factors for having seizures (such as brain injury,||
1500|094|P|stroke, brain tumor), heart disease (such as angina/chest pain,||
1500|095|P|heart attack), diabetes, high cholesterol or fats (triglycerides)||
1500|096|P|in your blood, falls, broken bones.||
1500|097|P|   Since this medication may rarely cause seizures in some||
1500|098|P|people, ask your doctor if you should avoid activities where a||
1500|099|P|sudden loss of consciousness may cause serious harm to you or||
1500|100|P|others.||
1500|101|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1500|102|P|can make you more dizzy. Do not drive, use machinery, or do||
1500|103|P|anything that needs alertness until you can do it safely. Limit||
1500|104|P|alcoholic beverages. Talk to your doctor if you are using||
1500|105|P|marijuana (cannabis).||
1500|106|P|   Before having surgery, tell your doctor or dentist about all||
1500|107|P|the products you use (including prescription drugs,||
1500|108|P|nonprescription drugs, and herbal products).||
1500|109|P|   Since this drug can be absorbed through the skin and lungs and||
1500|110|P|may harm an unborn baby, women who are pregnant or who may become||
1500|111|P|pregnant should not handle this medication or breathe the dust||
1500|112|P|from the capsules or tablets.||
1500|113|P|   This medication should not be used in women, especially during||
1500|114|P|pregnancy or breastfeeding. It may harm an unborn or||
1500|115|P|breastfeeding baby. Consult your doctor for more details.||
1500|116|P|   Men who have a pregnant partner must use a condom during||
1500|117|P|sexual activity during enzalutamide treatment and for 3 months||
1500|118|P|after treatment has stopped. Men with a female partner of||
1500|119|P|childbearing age who is not pregnant should use a condom and||
1500|120|P|another form of birth control during enzalutamide treatment and||
1500|121|P|for 3 months after treatment has stopped. Ask your doctor for||
1500|122|P|more details. If your partner becomes pregnant or thinks she may||
1500|123|P|be pregnant, tell the doctor right away.||
1500|124|B|||
1500|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1500|126|I|medications work or increase your risk for serious side effects.||
1500|127|I|This document does not contain all possible drug interactions.||
1500|128|I|Keep a list of all the products you use (including||
1500|129|I|prescription/nonprescription drugs and herbal products) and share||
1500|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
1500|131|I|the dosage of any medicines without your doctor's approval.||
1500|132|I|   Other medications can affect the removal of enzalutamide from||
1500|133|I|your body, which may affect how enzalutamide works. Examples||
1500|134|I|include seizure medications (such as phenobarbital, phenytoin),||
1500|135|I|St. John's wort, among others.||
1500|136|I|   Enzalutamide can speed up the removal of other medications||
1500|137|I|from your body, which may affect how they work. Examples of||
1500|138|I|affected drugs include cobicistat, ergot alkaloids (such as||
1500|139|I|dihydroergotamine, ergotamine), fentanyl, lurasidone, pimozide,||
1500|140|I|quinidine, sirolimus, suvorexant, tacrolimus, voriconazole, among||
1500|141|I|others.||
1500|142|B|||
1500|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1500|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1500|145|O|poison control center right away. US residents can call||
1500|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1500|147|O|Symptoms of overdose may include seizures.||
1500|148|B|||
1500|149|N|NOTES:  Do not share this medication with others.||
1500|150|N|   Lab and/or medical tests (such as blood pressure) should be||
1500|151|N|done while you are taking this medication. Keep all medical and||
1500|152|N|lab appointments. Consult your doctor for more details.||
1500|153|B|||
1500|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1500|155|D|remember. If it is near the time of the next dose, skip the||
1500|156|D|missed dose. Take your next dose at the regular time. Do not||
1500|157|D|double the dose to catch up.||
1500|158|B|||
1500|159|R|STORAGE:  Store at room temperature away from light and moisture.||
1500|160|R|Do not store in the bathroom. Keep all medications away from||
1500|161|R|children and pets.||
1500|162|R|   Do not flush medications down the toilet or pour them into a||
1500|163|R|drain unless instructed to do so. Properly discard this product||
1500|164|R|when it is expired or no longer needed. Consult your pharmacist||
1500|165|R|or local waste disposal company.||
1500|166|B|||
1500|167|A|Information last revised April 2025.||
1500|168|A|Copyright(c) 2025 First Databank, Inc.||
1500|169|B|||
1501|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1501|002|Z|does NOT have all possible information about this product. This||
1501|003|Z|information does not assure that this product is safe, effective,||
1501|004|Z|or appropriate for you. This information is not individual||
1501|005|Z|medical advice and does not substitute for the advice of your||
1501|006|Z|health care professional. Always ask your health care||
1501|007|Z|professional for complete information about this product and your||
1501|008|Z|specific health needs.||
1501|009|B|||
1501|010|T|PALONOSETRON - ORAL||
1501|011|F|(PAL-oh-NOE-se-tron)||
1501|012|B|||
1501|013|U|USES:  Palonosetron is used to prevent nausea and vomiting caused||
1501|014|U|by cancer chemotherapy. It works by blocking a natural substance||
1501|015|U|in the body, called serotonin, that causes vomiting.||
1501|016|B|||
1501|017|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1501|018|H|from your pharmacist before you start taking palonosetron and||
1501|019|H|each time you get a refill. If you have any questions, ask your||
1501|020|H|doctor or pharmacist.||
1501|021|H|   Take this medication by mouth with or without food as directed||
1501|022|H|by your doctor, usually 1 hour before the start of chemotherapy.||
1501|023|H|   Tell your doctor if you develop nausea or vomiting.||
1501|024|B|||
1501|025|S|SIDE EFFECTS:  Headache may occur. If this effect lasts or gets||
1501|026|S|worse, tell your doctor or pharmacist promptly.||
1501|027|S|   Remember that this medication has been prescribed because your||
1501|028|S|doctor has judged that the benefit to you is greater than the||
1501|029|S|risk of side effects. Many people using this medication do not||
1501|030|S|have serious side effects.||
1501|031|S|   This medication may increase serotonin and rarely cause a very||
1501|032|S|serious condition called serotonin syndrome/toxicity. The risk||
1501|033|S|increases if you are also taking other drugs that increase||
1501|034|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1501|035|S|take (see Drug Interactions section). Get medical help right away||
1501|036|S|if you develop some of the following symptoms: fast heartbeat,||
1501|037|S|hallucinations, loss of coordination, severe dizziness, severe||
1501|038|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1501|039|S|unusual agitation/restlessness.||
1501|040|S|   A very serious allergic reaction to this drug is rare.||
1501|041|S|However, get medical help right away if you notice any symptoms||
1501|042|S|of a serious allergic reaction, including: rash, itching/swelling||
1501|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1501|044|S|breathing.||
1501|045|S|   This is not a complete list of possible side effects. If you||
1501|046|S|notice other effects not listed above, contact your doctor or||
1501|047|S|pharmacist.||
1501|048|S|   In the US -||
1501|049|S|   Call your doctor for medical advice about side effects. You||
1501|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1501|051|S|www.fda.gov/medwatch.||
1501|052|S|   In Canada - Call your doctor for medical advice about side||
1501|053|S|effects. You may report side effects to Health Canada at||
1501|054|S|1-866-234-2345.||
1501|055|B|||
1501|056|P|PRECAUTIONS:  Before taking palonosetron, tell your doctor or||
1501|057|P|pharmacist if you are allergic to it; or to other anti-nausea||
1501|058|P|serotonin blockers (such as ondansetron, granisetron); or if you||
1501|059|P|have any other allergies. This product may contain inactive||
1501|060|P|ingredients, which can cause allergic reactions or other||
1501|061|P|problems. Talk to your pharmacist for more details.||
1501|062|P|   Before using this medication, tell your doctor or pharmacist||
1501|063|P|your medical history.||
1501|064|P|   Before having surgery, tell your doctor or dentist about all||
1501|065|P|the products you use (including prescription drugs,||
1501|066|P|nonprescription drugs, and herbal products).||
1501|067|P|   During pregnancy, this medication should be used only when||
1501|068|P|clearly needed. Discuss the risks and benefits with your doctor.||
1501|069|P|   It is unknown if this medication passes into breast milk.||
1501|070|P|Consult your doctor before breastfeeding.||
1501|071|B|||
1501|072|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1501|073|I|medications work or increase your risk for serious side effects.||
1501|074|I|This document does not contain all possible drug interactions.||
1501|075|I|Keep a list of all the products you use (including||
1501|076|I|prescription/nonprescription drugs and herbal products) and share||
1501|077|I|it with your doctor and pharmacist. Do not start, stop, or change||
1501|078|I|the dosage of any medicines without your doctor's approval.||
1501|079|I|   The risk of serotonin syndrome/toxicity increases if you are||
1501|080|I|also taking other drugs that increase serotonin. Examples include||
1501|081|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1501|082|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1501|083|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1501|084|I|serotonin syndrome/toxicity may be more likely when you start or||
1501|085|I|increase the dose of these drugs.||
1501|086|B|||
1501|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1501|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1501|089|O|poison control center right away. US residents can call||
1501|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1501|091|B|||
1501|092|N|NOTES:  Do not share this medication with others.||
1501|093|B|||
1501|094|D|MISSED DOSE:  It is important to take each dose of this||
1501|095|D|medication as scheduled. If you miss a dose, ask your doctor or||
1501|096|D|pharmacist right away for a new dosing schedule. Do not double||
1501|097|D|the dose to catch up.||
1501|098|B|||
1501|099|R|STORAGE:  Store at room temperature away from light and moisture.||
1501|100|R|Do not store in the bathroom. Keep all medications away from||
1501|101|R|children and pets.||
1501|102|R|   Do not flush medications down the toilet or pour them into a||
1501|103|R|drain unless instructed to do so. Properly discard this product||
1501|104|R|when it is expired or no longer needed. Consult your pharmacist||
1501|105|R|or local waste disposal company.||
1501|106|B|||
1501|107|A|Information last revised May 2024.||
1501|108|A|Copyright(c) 2025 First Databank, Inc.||
1501|109|B|||
1502|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1502|002|Z|does NOT have all possible information about this product. This||
1502|003|Z|information does not assure that this product is safe, effective,||
1502|004|Z|or appropriate for you. This information is not individual||
1502|005|Z|medical advice and does not substitute for the advice of your||
1502|006|Z|health care professional. Always ask your health care||
1502|007|Z|professional for complete information about this product and your||
1502|008|Z|specific health needs.||
1502|009|B|||
1502|010|T|TRIPTORELIN - INJECTION||
1502|011|F|(TRIP-toe-REL-in)||
1502|012|B|||
1502|013|U|USES:  Triptorelin is used by women as part of female infertility||
1502|014|U|treatment in assisted reproductive technologies (ART). This||
1502|015|U|medication is a hormone which works by helping the growth and||
1502|016|U|release of mature eggs from the ovaries (ovulation).||
1502|017|B|||
1502|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1502|019|H|from your pharmacist before you start using triptorelin and each||
1502|020|H|time you get a refill. Ask your health care professional how to||
1502|021|H|prepare and use this medication. If you have any questions, ask||
1502|022|H|your doctor or pharmacist.||
1502|023|H|   You must have a pregnancy test before starting treatment with||
1502|024|H|this medication. You should receive the first dose from your||
1502|025|H|health care provider who will monitor you for side effects. Each||
1502|026|H|treatment with this medication usually lasts 4 to 7 weeks.||
1502|027|H|   Inject this medication under the skin as directed by your||
1502|028|H|doctor, usually once daily starting on a specified day of your||
1502|029|H|menstrual cycle. The injection is given in the lower abdomen. The||
1502|030|H|dosage is based on your medical condition and response to||
1502|031|H|treatment. Keep all medical appointments so your doctor can||
1502|032|H|closely monitor your response and adjust your dosage if||
1502|033|H|necessary. Do not increase your dose or use this drug more often||
1502|034|H|or for longer than prescribed.||
1502|035|H|   Before using, check this product for particles or||
1502|036|H|discoloration. If either is present, do not use the liquid.||
1502|037|H|Before injecting each dose, clean the skin you are going to||
1502|038|H|inject into (the injection site) with rubbing alcohol. Change the||
1502|039|H|injection site each time to lessen injury under the skin. To||
1502|040|H|lessen bruising, do not rub the injection site after a shot.||
1502|041|H|Learn how to store and discard medical supplies safely.||
1502|042|B|||
1502|043|S|SIDE EFFECTS:  Headache, dizziness, nausea, hot flashes||
1502|044|S|(flushing), unusual sweating, trouble sleeping, breast||
1502|045|S|tenderness, vaginal dryness, decreased sexual interest, and||
1502|046|S|injection site reactions (such as mild irritation, redness) may||
1502|047|S|occur. Mild abdominal pain may occur with vaginal bleeding or||
1502|048|S|spotting. If any of these effects last or get worse, tell your||
1502|049|S|doctor or pharmacist promptly.||
1502|050|S|   Remember that this medication has been prescribed because your||
1502|051|S|doctor has judged that the benefit to you is greater than the||
1502|052|S|risk of side effects. Many people using this medication do not||
1502|053|S|have serious side effects.||
1502|054|S|   Tell your doctor right away if you have any serious side||
1502|055|S|effects, including: mental/mood changes (such as depression,||
1502|056|S|agitation), muscle spasms, joint pain.||
1502|057|S|   This medication may cause a condition known as ovarian||
1502|058|S|hyperstimulation syndrome (OHSS). This condition may occur during||
1502|059|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
1502|060|S|build up in the stomach, chest, and heart area. Get medical help||
1502|061|S|right away if you develop the following side effects: severe pain||
1502|062|S|or swelling in the lower abdominal (pelvic) area, severe||
1502|063|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
1502|064|S|urination.||
1502|065|S|   A very serious allergic reaction to this drug is rare.||
1502|066|S|However, get medical help right away if you notice any symptoms||
1502|067|S|of a serious allergic reaction, including: fever, swollen lymph||
1502|068|S|nodes, rash, itching/swelling (especially of the||
1502|069|S|face/tongue/throat), severe dizziness, trouble breathing.||
1502|070|S|   This is not a complete list of possible side effects. If you||
1502|071|S|notice other effects not listed above, contact your doctor or||
1502|072|S|pharmacist.||
1502|073|S|   In the US -||
1502|074|S|   Call your doctor for medical advice about side effects. You||
1502|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1502|076|S|www.fda.gov/medwatch.||
1502|077|S|   In Canada - Call your doctor for medical advice about side||
1502|078|S|effects. You may report side effects to Health Canada at||
1502|079|S|1-866-234-2345.||
1502|080|B|||
1502|081|P|PRECAUTIONS:  Before using triptorelin, tell your doctor or||
1502|082|P|pharmacist if you are allergic to it; or if you have any other||
1502|083|P|allergies. This product may contain inactive ingredients, which||
1502|084|P|can cause allergic reactions or other problems. Talk to your||
1502|085|P|pharmacist for more details.||
1502|086|P|   Before using this medication, tell your doctor or pharmacist||
1502|087|P|your medical history, especially of: a certain brain tumor||
1502|088|P|(pituitary adenoma), bone loss (osteoporosis), cancer of the||
1502|089|P|reproductive organs (such as ovary, breast, uterus), heart||
1502|090|P|problems (such as heart failure, slow/irregular heartbeat, QT||
1502|091|P|prolongation in the EKG), family history of certain heart||
1502|092|P|problems (QT prolongation in the EKG, sudden cardiac death),||
1502|093|P|mental/mood disorders (such as depression), ovarian cysts.||
1502|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1502|095|P|can make you more dizzy. Do not drive, use machinery, or do||
1502|096|P|anything that needs alertness until you can do it safely. Limit||
1502|097|P|alcoholic beverages. Talk to your doctor if you are using||
1502|098|P|marijuana (cannabis).||
1502|099|P|   Before having surgery, tell your doctor or dentist about all||
1502|100|P|the products you use (including prescription drugs,||
1502|101|P|nonprescription drugs, and herbal products).||
1502|102|P|   Use of triptorelin may increase the risk of pregnancy outside||
1502|103|P|of the womb (ectopic pregnancy), miscarriage, multiple births||
1502|104|P|(such as twins, triplets), or birth defects in an unborn baby.||
1502|105|P|Discuss the risks and benefits with your doctor.||
1502|106|P|   This medication is not for use during pregnancy. If you become||
1502|107|P|pregnant or think you may be pregnant, tell your doctor right||
1502|108|P|away.||
1502|109|P|   It is unknown if triptorelin passes into breast milk. This||
1502|110|P|medication is usually not used by nursing women. Breastfeeding is||
1502|111|P|not recommended while using this medication. Consult your doctor||
1502|112|P|before breastfeeding.||
1502|113|B|||
1502|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1502|115|I|medications work or increase your risk for serious side effects.||
1502|116|I|This document does not contain all possible drug interactions.||
1502|117|I|Keep a list of all the products you use (including||
1502|118|I|prescription/nonprescription drugs and herbal products) and share||
1502|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
1502|120|I|the dosage of any medicines without your doctor's approval.||
1502|121|B|||
1502|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1502|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1502|124|O|poison control center right away. US residents can call||
1502|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1502|126|B|||
1502|127|N|NOTES:  Do not share this medication with others.||
1502|128|N|   Lab and/or medical tests (such as ultrasound, blood hormone||
1502|129|N|levels for estradiol) should be done while you are using this||
1502|130|N|medication. A pregnancy test must be completed before you start||
1502|131|N|treatment. Keep all medical and lab appointments. Consult your||
1502|132|N|doctor for more details.||
1502|133|B|||
1502|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1502|135|D|If you don't remember until the next day, skip the missed dose.||
1502|136|D|Use your next dose at the regular time. Do not double the dose to||
1502|137|D|catch up.||
1502|138|B|||
1502|139|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
1502|140|R|medications away from children and pets.||
1502|141|R|   Do not flush medications down the toilet or pour them into a||
1502|142|R|drain unless instructed to do so. Properly discard this product||
1502|143|R|when it is expired or no longer needed. Consult your pharmacist||
1502|144|R|or local waste disposal company.||
1502|145|B|||
1502|146|A|Information last revised September 2025.||
1502|147|A|Copyright(c) 2025 First Databank, Inc.||
1502|148|B|||
1503|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1503|002|Z|does NOT have all possible information about this product. This||
1503|003|Z|information does not assure that this product is safe, effective,||
1503|004|Z|or appropriate for you. This information is not individual||
1503|005|Z|medical advice and does not substitute for the advice of your||
1503|006|Z|health care professional. Always ask your health care||
1503|007|Z|professional for complete information about this product and your||
1503|008|Z|specific health needs.||
1503|009|B|||
1503|010|T|REGORAFENIB - ORAL||
1503|011|F|(RE-goe-RAF-e-nib)||
1503|012|B|||
1503|013|C|COMMON BRAND NAME(S): Stivarga||
1503|014|B|||
1503|015|W|WARNING:  Regorafenib has rarely caused very serious (possibly||
1503|016|W|fatal) liver disease, especially in the first 2 months of||
1503|017|W|treatment. People of Asian descent are at greater risk. Your||
1503|018|W|doctor will monitor your liver function before and during||
1503|019|W|treatment with this medication. Tell your doctor right away if||
1503|020|W|you develop new or worsening symptoms of liver disease, such as||
1503|021|W|nausea/vomiting that doesn't stop, severe stomach/abdominal pain,||
1503|022|W|dark urine, yellowing eyes/skin.||
1503|023|B|||
1503|024|U|USES:  Regorafenib is used to treat cancer of the colon and||
1503|025|U|rectum. It is also used to treat liver cancer and a certain||
1503|026|U|cancer of the digestive system (gastrointestinal stromal tumor).||
1503|027|U|It works by slowing or stopping the growth of cancer cells.||
1503|028|B|||
1503|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1503|030|H|from your pharmacist before you start taking regorafenib and each||
1503|031|H|time you get a refill. If you have any questions, ask your doctor||
1503|032|H|or pharmacist.||
1503|033|H|   Take this medication by mouth with a low-fat meal as directed||
1503|034|H|by your doctor, usually once daily for 21 days, then stopping the||
1503|035|H|medication for 7 days. This is one cycle of treatment. Keep||
1503|036|H|taking the medication this way as directed by your doctor.||
1503|037|H|Swallow the medication whole. Do not crush, chew, or split the||
1503|038|H|tablets.||
1503|039|H|   The dosage is based on your medical condition and response to||
1503|040|H|treatment. Do not increase your dose or use this drug more often||
1503|041|H|or for longer than prescribed. Your condition will not improve||
1503|042|H|any faster, and your risk of serious side effects will increase.||
1503|043|H|   Take this medication regularly to get the most benefit from||
1503|044|H|it. Remember to take it at the same time each day that you are||
1503|045|H|scheduled to take it.||
1503|046|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1503|047|H|using this medication unless your doctor or pharmacist says you||
1503|048|H|may do so safely. Grapefruit can increase the chance of side||
1503|049|H|effects with this medicine. Ask your doctor or pharmacist for||
1503|050|H|more details.||
1503|051|H|   Since this drug can be absorbed through the skin and lungs and||
1503|052|H|may harm an unborn baby, women who are pregnant or who may become||
1503|053|H|pregnant should not handle this medication or breathe the dust||
1503|054|H|from the tablets.||
1503|055|B|||
1503|056|S|SIDE EFFECTS:  See also Warning section.||
1503|057|S|   Diarrhea, pain/sores in the mouth/throat, changes in taste,||
1503|058|S|dry mouth, loss of appetite, hair loss, voice changes, weight||
1503|059|S|loss, or muscle stiffness may occur. If any of these effects last||
1503|060|S|or get worse, tell your doctor or pharmacist promptly.||
1503|061|S|   People using this medication may have serious side effects.||
1503|062|S|However, you have been prescribed this drug because your doctor||
1503|063|S|has judged that the benefit to you is greater than the risk of||
1503|064|S|side effects. Careful monitoring by your doctor may decrease your||
1503|065|S|risk.||
1503|066|S|   Treatment with this drug may sometimes cause your hands/feet||
1503|067|S|to develop a skin reaction called hand-foot skin reaction||
1503|068|S|(palmar-plantar erythrodysesthesia). People of Asian descent are||
1503|069|S|at greater risk. Tell your doctor right away if you experience||
1503|070|S|swelling, pain, redness, peeling, blisters, or tingling/burning||
1503|071|S|of the hands/feet. The symptoms can be made worse by||
1503|072|S|heat/pressure on your hands/feet. Avoid prolonged sun exposure,||
1503|073|S|tanning booths, and sunlamps, as well as unnecessary exposure to||
1503|074|S|heat (for example, hot dishwater, long hot baths). Use a||
1503|075|S|sunscreen and wear protective clothing when outdoors. Avoid||
1503|076|S|pressure on elbows, knees, and soles of feet (such as leaning on||
1503|077|S|elbows, kneeling, taking long walks). Wear loose clothing and||
1503|078|S|comfortable shoes. Depending on how severe your hand-foot||
1503|079|S|reaction is, your doctor may give you an additional medication to||
1503|080|S|reduce the symptoms, or stop or delay your regorafenib treatment.||
1503|081|S|   This medication may raise your blood pressure. Check your||
1503|082|S|blood pressure regularly and tell your doctor if the results are||
1503|083|S|high. Your doctor may control your blood pressure with||
1503|084|S|medication.||
1503|085|S|   Tell your doctor right away if you have any serious side||
1503|086|S|effects, including: slow wound healing, signs of dehydration||
1503|087|S|(such as extreme thirst, dizziness, decreased urination), signs||
1503|088|S|of mineral imbalance (such as muscle cramps/weakness, irregular||
1503|089|S|heartbeat, mental/mood changes), signs of infection (such as sore||
1503|090|S|throat that doesn't go away, fever, chills), signs of underactive||
1503|091|S|thyroid (weight gain, cold intolerance, unusual tiredness, slow||
1503|092|S|heartbeat).||
1503|093|S|   This medication can cause serious bleeding. Tell your doctor||
1503|094|S|right away if you have any signs of serious bleeding, including:||
1503|095|S|easy bleeding/bruising, severe stomach/abdominal pain, vomit that||
1503|096|S|is bloody or looks like coffee grounds, black/tarry stool,||
1503|097|S|unusual vaginal bleeding, pink/bloody urine, coughing up blood.||
1503|098|S|   Get medical help right away if you have any very serious side||
1503|099|S|effects, including: signs of a heart attack (such as||
1503|100|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
1503|101|S|sudden/severe back pain, seizure, severe headache, confusion,||
1503|102|S|sudden vision changes, weakness on one side of the body, trouble||
1503|103|S|speaking.||
1503|104|S|   A very serious allergic reaction to this drug is rare.||
1503|105|S|However, get medical help right away if you notice any symptoms||
1503|106|S|of a serious allergic reaction, including: rash, itching/swelling||
1503|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1503|108|S|breathing.||
1503|109|S|   Regorafenib can commonly cause a mild rash that is usually not||
1503|110|S|serious. However, you may not be able to tell it apart from a||
1503|111|S|rare rash that could be a sign of a severe allergic reaction. Get||
1503|112|S|medical help right away if you develop any rash.||
1503|113|S|   This is not a complete list of possible side effects. If you||
1503|114|S|notice other effects not listed above, contact your doctor or||
1503|115|S|pharmacist.||
1503|116|S|   In the US -||
1503|117|S|   Call your doctor for medical advice about side effects. You||
1503|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1503|119|S|www.fda.gov/medwatch.||
1503|120|S|   In Canada - Call your doctor for medical advice about side||
1503|121|S|effects. You may report side effects to Health Canada at||
1503|122|S|1-866-234-2345.||
1503|123|B|||
1503|124|P|PRECAUTIONS:  Before taking regorafenib, tell your doctor or||
1503|125|P|pharmacist if you are allergic to it; or if you have any other||
1503|126|P|allergies. This product may contain inactive ingredients, which||
1503|127|P|can cause allergic reactions or other problems. Talk to your||
1503|128|P|pharmacist for more details.||
1503|129|P|   Before using this medication, tell your doctor or pharmacist||
1503|130|P|your medical history, especially of: liver problems, high blood||
1503|131|P|pressure, heart disease (such as heart attack, chest pain),||
1503|132|P|bleeding problems (such as bleeding of the stomach/intestines),||
1503|133|P|blood vessel problems (such as an aneurysm or a tear/break in the||
1503|134|P|aorta or other blood vessels), recent major surgery/injury.||
1503|135|P|   Before having surgery, tell your doctor or dentist about all||
1503|136|P|the products you use (including prescription drugs,||
1503|137|P|nonprescription drugs, and herbal products). Your doctor or||
1503|138|P|dentist may tell you to stop taking regorafenib at least 2 weeks||
1503|139|P|before surgery. This medication may cause wounds to heal more||
1503|140|P|slowly. Follow all instructions about when to stop or restart||
1503|141|P|this medication.||
1503|142|P|   Tell your health care professional that you are using||
1503|143|P|regorafenib before having any immunizations/vaccinations. Avoid||
1503|144|P|contact with people who have recently received live vaccines||
1503|145|P|(such as flu vaccine inhaled through the nose).||
1503|146|P|   To lower the chance of getting cut, bruised, or injured, use||
1503|147|P|caution with sharp objects like razors and nail cutters, and||
1503|148|P|avoid activities such as contact sports.||
1503|149|P|   Older adults may be at greater risk for high blood pressure||
1503|150|P|while using this drug.||
1503|151|P|   Tell your doctor if you are pregnant or plan to become||
1503|152|P|pregnant. You should not become pregnant while using regorafenib.||
1503|153|P|Regorafenib may harm an unborn baby. Men and women using this||
1503|154|P|medication should ask about reliable forms of birth control||
1503|155|P|during treatment and for 2 months after the last dose. If you or||
1503|156|P|your partner becomes pregnant, talk to your doctor right away||
1503|157|P|about the risks and benefits of this medication.||
1503|158|P|   Since this drug can be absorbed through the skin and lungs and||
1503|159|P|may harm an unborn baby, women who are pregnant or who may become||
1503|160|P|pregnant should not handle this medication or breathe the dust||
1503|161|P|from the tablets.||
1503|162|P|   It is unknown if this medication passes into breast milk.||
1503|163|P|Because of the possible risk to the infant, breastfeeding is not||
1503|164|P|recommended while using this medication and for 2 weeks after the||
1503|165|P|last dose. Consult your doctor before breastfeeding.||
1503|166|B|||
1503|167|I|DRUG INTERACTIONS:  See also How to Use section.||
1503|168|I|   Drug interactions may change how your medications work or||
1503|169|I|increase your risk for serious side effects. This document does||
1503|170|I|not contain all possible drug interactions. Keep a list of all||
1503|171|I|the products you use (including prescription/nonprescription||
1503|172|I|drugs and herbal products) and share it with your doctor and||
1503|173|I|pharmacist. Do not start, stop, or change the dosage of any||
1503|174|I|medicines without your doctor's approval.||
1503|175|I|   Some products that may interact with this drug include:||
1503|176|I|irinotecan, other drugs that can cause bleeding/bruising||
1503|177|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
1503|178|I|ibuprofen, "blood thinners" such as warfarin).||
1503|179|I|   Aspirin can increase the risk of bleeding when used with this||
1503|180|I|medication. However, if your doctor has told you to take low-dose||
1503|181|I|aspirin to prevent heart attack or stroke (usually 81-162||
1503|182|I|milligrams a day), you should keep taking the aspirin unless your||
1503|183|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1503|184|I|details.||
1503|185|I|   Other medications can affect the removal of regorafenib from||
1503|186|I|your body, which may affect how regorafenib works. Examples||
1503|187|I|include nefazodone, ritonavir, St. John's wort, telithromycin,||
1503|188|I|azole antifungals (such as ketoconazole, itraconazole), macrolide||
1503|189|I|antibiotics (such as clarithromycin), HIV protease inhibitors||
1503|190|I|(such as nelfinavir), rifamycins (such as rifabutin, rifampin),||
1503|191|I|drugs used to treat seizures (such as phenytoin), among others.||
1503|192|B|||
1503|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1503|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1503|195|O|poison control center right away. US residents can call||
1503|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1503|197|B|||
1503|198|N|NOTES:  Do not share this medication with others.||
1503|199|N|   Lab and/or medical tests (such as liver function, complete||
1503|200|N|blood count, blood mineral levels, blood pressure, urine protein||
1503|201|N|test) should be done while you are taking this medication. Keep||
1503|202|N|all medical and lab appointments. Consult your doctor for more||
1503|203|N|details.||
1503|204|B|||
1503|205|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1503|206|D|remember. If you don't remember until the next day, skip the||
1503|207|D|missed dose. Take your next dose at the regular time. Do not||
1503|208|D|double the dose to catch up.||
1503|209|B|||
1503|210|R|STORAGE:  Store in the original bottle at room temperature away||
1503|211|R|from light and moisture. Do not store in the bathroom. Keep the||
1503|212|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1503|213|R|when not in use. Once the bottle is opened, this medication||
1503|214|R|expires after 7 weeks. Keep all medications away from children||
1503|215|R|and pets.||
1503|216|R|   Do not flush medications down the toilet or pour them into a||
1503|217|R|drain unless instructed to do so. Properly discard this product||
1503|218|R|when it is expired or no longer needed. Consult your pharmacist||
1503|219|R|or local waste disposal company.||
1503|220|B|||
1503|221|A|Information last revised July 2024.||
1503|222|A|Copyright(c) 2025 First Databank, Inc.||
1503|223|B|||
1504|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1504|002|Z|does NOT have all possible information about this product. This||
1504|003|Z|information does not assure that this product is safe, effective,||
1504|004|Z|or appropriate for you. This information is not individual||
1504|005|Z|medical advice and does not substitute for the advice of your||
1504|006|Z|health care professional. Always ask your health care||
1504|007|Z|professional for complete information about this product and your||
1504|008|Z|specific health needs.||
1504|009|B|||
1504|010|T|TERIFLUNOMIDE - ORAL||
1504|011|F|(TER-i-FLOO-noe-mide)||
1504|012|B|||
1504|013|C|COMMON BRAND NAME(S): Aubagio||
1504|014|B|||
1504|015|W|WARNING:  Teriflunomide must not be used during pregnancy because||
1504|016|W|it may cause serious harm (such as birth defects, death) in an||
1504|017|W|unborn baby. Women of childbearing age must have a negative||
1504|018|W|pregnancy test before starting this medication. Men and women||
1504|019|W|must use reliable forms of birth control (such as condoms, birth||
1504|020|W|control pills) while taking teriflunomide and for as long as||
1504|021|W|directed by your doctor to prevent pregnancy. After stopping||
1504|022|W|treatment with teriflunomide, your doctor may prescribe a||
1504|023|W|different drug to help speed up the removal of teriflunomide from||
1504|024|W|your body. If you become pregnant or think you may be pregnant or||
1504|025|W|cause a pregnancy, tell your doctor right away. (See also How to||
1504|026|W|Use and Precautions sections.)||
1504|027|W|   This drug may rarely cause serious (possibly fatal) liver||
1504|028|W|disease. Careful monitoring by your doctor may help decrease your||
1504|029|W|risk. Your doctor will perform liver function tests before you||
1504|030|W|start treatment and once a month for at least the first 6 months||
1504|031|W|of treatment. Tell your doctor right away if you notice||
1504|032|W|nausea/vomiting that doesn't stop, dark urine, loss of appetite,||
1504|033|W|stomach/abdominal pain, or yellowing eyes/skin.||
1504|034|B|||
1504|035|U|USES:  This medication is used by adults to treat multiple||
1504|036|U|sclerosis-MS. It is not a cure for MS but is thought to work by||
1504|037|U|decreasing certain immune system cells (lymphocytes) which can||
1504|038|U|attack the nerves in your brain and spinal cord. This helps||
1504|039|U|decrease the number of flare-ups (relapses) and may help slow||
1504|040|U|down physical problems caused by MS.||
1504|041|B|||
1504|042|H|HOW TO USE:  Read the Medication Guide provided by your||
1504|043|H|pharmacist before you start taking teriflunomide and each time||
1504|044|H|you get a refill. If you have any questions, ask your doctor or||
1504|045|H|pharmacist.||
1504|046|H|   Take this medication by mouth with or without food as directed||
1504|047|H|by your doctor, usually once daily. The dosage is based on your||
1504|048|H|medical condition and response to treatment.||
1504|049|H|   Take this medication regularly to get the most benefit from||
1504|050|H|it. To help you remember, take it at the same time each day.||
1504|051|H|   After treatment is stopped, your doctor may prescribe a||
1504|052|H|different drug (cholestyramine or activated charcoal powder) to||
1504|053|H|help speed up the removal of teriflunomide from your body. This||
1504|054|H|may be used if you have severe side effects, or if you are a||
1504|055|H|woman of childbearing age, or a man planning to father a child.||
1504|056|H|Otherwise, teriflunomide can stay in your body for as long as 2||
1504|057|H|years after stopping treatment. Consult your doctor or pharmacist||
1504|058|H|for more details.||
1504|059|H|   Tell your doctor if your symptoms do not get better or if they||
1504|060|H|get worse.||
1504|061|B|||
1504|062|S|SIDE EFFECTS:  See also Warning section.||
1504|063|S|   Diarrhea, nausea, or tingling/burning/numbness/prickling||
1504|064|S|feelings in your skin may occur. If any of these effects last or||
1504|065|S|get worse, tell your doctor or pharmacist promptly.||
1504|066|S|   Temporary hair loss may occur. Normal hair growth should||
1504|067|S|return after treatment has ended.||
1504|068|S|   Remember that this medication has been prescribed because your||
1504|069|S|doctor has judged that the benefit to you is greater than the||
1504|070|S|risk of side effects. Many people using this medication do not||
1504|071|S|have serious side effects.||
1504|072|S|   Tell your doctor right away if you have any serious side||
1504|073|S|effects, including: easy bruising/bleeding, new/worsening||
1504|074|S|shortness of breath, new/worsening numbness/tingling of||
1504|075|S|hands/feet, pain in your side (flank pain), symptoms of high||
1504|076|S|potassium blood levels (such as muscle weakness, slow/irregular||
1504|077|S|heartbeat), unusual tiredness.||
1504|078|S|   This medication may raise your blood pressure. Check your||
1504|079|S|blood pressure regularly and tell your doctor if the results are||
1504|080|S|high.||
1504|081|S|   This medication may lower your ability to fight infections.||
1504|082|S|This may make you more likely to get a serious (rarely fatal)||
1504|083|S|infection or make any infection you have worse. Get medical help||
1504|084|S|right away if you have any signs of infection (such as sore||
1504|085|S|throat that doesn't go away, fever, chills, swollen lymph nodes).||
1504|086|S|   Teriflunomide can cause a mild rash that is usually not||
1504|087|S|serious. However, you may not be able to tell it apart from a||
1504|088|S|rare rash that could be a sign of a severe allergic reaction. Get||
1504|089|S|medical help right away if you develop any rash.||
1504|090|S|   A very serious allergic reaction to this drug is rare.||
1504|091|S|However, get medical help right away if you notice any symptoms||
1504|092|S|of a serious allergic reaction, including: rash, itching/swelling||
1504|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1504|094|S|breathing.||
1504|095|S|   This is not a complete list of possible side effects. If you||
1504|096|S|notice other effects not listed above, contact your doctor or||
1504|097|S|pharmacist.||
1504|098|S|   In the US -||
1504|099|S|   Call your doctor for medical advice about side effects. You||
1504|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1504|101|S|www.fda.gov/medwatch.||
1504|102|S|   In Canada - Call your doctor for medical advice about side||
1504|103|S|effects. You may report side effects to Health Canada at||
1504|104|S|1-866-234-2345.||
1504|105|B|||
1504|106|P|PRECAUTIONS:  Before taking teriflunomide, tell your doctor or||
1504|107|P|pharmacist if you are allergic to it; or to leflunomide; or if||
1504|108|P|you have any other allergies. This product may contain inactive||
1504|109|P|ingredients, which can cause allergic reactions or other||
1504|110|P|problems. Talk to your pharmacist for more details.||
1504|111|P|   Before using this medication, tell your doctor or pharmacist||
1504|112|P|your medical history, especially of: bone marrow/blood disorder,||
1504|113|P|immune system disorder (such as due to cancer, HIV infection),||
1504|114|P|current/recent infection (such as tuberculosis), high blood||
1504|115|P|pressure, liver problems, lung disease.||
1504|116|P|   Teriflunomide can make you more likely to get infections or||
1504|117|P|may make current infections worse. Stay away from anyone who has||
1504|118|P|an infection that may easily spread (such as chickenpox,||
1504|119|P|COVID-19, measles, flu). Talk to your doctor if you have been||
1504|120|P|exposed to an infection or for more details.||
1504|121|P|   Tell your health care professional that you are using||
1504|122|P|teriflunomide before having any immunizations/vaccinations. Avoid||
1504|123|P|contact with people who have recently received live vaccines||
1504|124|P|(such as flu vaccine inhaled through the nose).||
1504|125|P|   To lower the chance of getting cut, bruised, or injured, use||
1504|126|P|caution with sharp objects like razors and nail cutters, and||
1504|127|P|avoid activities such as contact sports.||
1504|128|P|   Before having surgery, tell your doctor or dentist about all||
1504|129|P|the products you use (including prescription drugs,||
1504|130|P|nonprescription drugs, and herbal products).||
1504|131|P|   Teriflunomide may pass into the semen of men treated with this||
1504|132|P|medication and the effects on sperm are unknown. Men not wishing||
1504|133|P|to father a child with their female partners should use reliable||
1504|134|P|birth control (such as condoms). After stopping this medication,||
1504|135|P|men wishing to father a child should take a different drug as||
1504|136|P|prescribed by the doctor to speed up removal of teriflunomide||
1504|137|P|from the body. (See also How to Use section.)||
1504|138|P|   This medication must not be used during pregnancy. It may harm||
1504|139|P|an unborn baby. Before starting this medication, women of||
1504|140|P|childbearing age must have a negative pregnancy test. Discuss the||
1504|141|P|use of reliable forms of birth control (such as birth control||
1504|142|P|pills, intrauterine device-IUD) with your doctor. If you become||
1504|143|P|pregnant or think you may be pregnant, tell your doctor right||
1504|144|P|away. See also Warning section.||
1504|145|P|   This drug may pass into breast milk and could have undesirable||
1504|146|P|effects on a nursing infant. Breastfeeding is not recommended||
1504|147|P|while using this drug. Consult your doctor before breastfeeding.||
1504|148|B|||
1504|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1504|150|I|medications work or increase your risk for serious side effects.||
1504|151|I|This document does not contain all possible drug interactions.||
1504|152|I|Keep a list of all the products you use (including||
1504|153|I|prescription/nonprescription drugs and herbal products) and share||
1504|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
1504|155|I|the dosage of any medicines without your doctor's approval.||
1504|156|I|   This medication can slow down the removal of other medications||
1504|157|I|from your body, which may affect how they work. Examples of||
1504|158|I|affected drugs include ketorolac, tovorafenib, among others.||
1504|159|I|   This medication can speed up the removal of other medications||
1504|160|I|from your body, which may affect how they work. Examples of||
1504|161|I|affected drugs include vorasidenib, among others.||
1504|162|I|   Because leflunomide (used to treat rheumatoid arthritis) is||
1504|163|I|very similar to this medication, do not take it while you are||
1504|164|I|taking teriflunomide.||
1504|165|B|||
1504|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1504|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1504|168|O|poison control center right away. US residents can call||
1504|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1504|170|B|||
1504|171|N|NOTES:  Do not share this medication with others.||
1504|172|N|   Lab and/or medical tests (such as tuberculosis skin test,||
1504|173|N|kidney/liver function, complete blood counts, blood pressure,||
1504|174|N|potassium blood levels) should be done before you start taking||
1504|175|N|this medication and while you are taking it. Keep all medical and||
1504|176|N|lab appointments. Consult your doctor for more details.||
1504|177|B|||
1504|178|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1504|179|D|remember. If it is near the time of the next dose, skip the||
1504|180|D|missed dose. Take your next dose at the regular time. Do not||
1504|181|D|double the dose to catch up.||
1504|182|B|||
1504|183|R|STORAGE:  Store at room temperature away from light and moisture.||
1504|184|R|Do not store in the bathroom. Keep all medications away from||
1504|185|R|children and pets.||
1504|186|R|   Do not flush medications down the toilet or pour them into a||
1504|187|R|drain unless instructed to do so. Properly discard this product||
1504|188|R|when it is expired or no longer needed. Consult your pharmacist||
1504|189|R|or local waste disposal company.||
1504|190|B|||
1504|191|M|MEDICAL ALERT:  Your condition can cause complications in a||
1504|192|M|medical emergency. For information about enrolling in MedicAlert,||
1504|193|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1504|194|B|||
1504|195|A|Information last revised April 2025.||
1504|196|A|Copyright(c) 2025 First Databank, Inc.||
1504|197|B|||
1505|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1505|002|Z|does NOT have all possible information about this product. This||
1505|003|Z|information does not assure that this product is safe, effective,||
1505|004|Z|or appropriate for you. This information is not individual||
1505|005|Z|medical advice and does not substitute for the advice of your||
1505|006|Z|health care professional. Always ask your health care||
1505|007|Z|professional for complete information about this product and your||
1505|008|Z|specific health needs.||
1505|009|B|||
1505|010|T|SODIUM PICOSULFATE/MAGNESIUM OXIDE/CITRIC ACID - ORAL||
1505|011|B|||
1505|012|C|COMMON BRAND NAME(S): Clenpiq, Prepopik||
1505|013|B|||
1505|014|U|USES:  Sodium picosulfate/magnesium oxide/citric acid solution is||
1505|015|U|used to clean out the intestines before surgery or certain||
1505|016|U|procedures (such as colonoscopy, X-rays). It is a laxative that||
1505|017|U|works by drawing large amounts of water into your intestines and||
1505|018|U|stimulating the colon. This causes watery bowel movements||
1505|019|U|(diarrhea). Clearing stool from the intestines helps your doctor||
1505|020|U|to better examine the inside of your colon.||
1505|021|B|||
1505|022|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1505|023|H|Instructions for Use provided by your pharmacist before you start||
1505|024|H|using this product and each time you get a refill. Be sure to||
1505|025|H|read and follow all instructions for use from your doctor or the||
1505|026|H|manufacturer before taking this product. If you have any||
1505|027|H|questions, ask your doctor or pharmacist.||
1505|028|H|   Follow any special diet instructions provided by your doctor.||
1505|029|H|Usually, you may only have clear liquids on the day before your||
1505|030|H|procedure. Do not drink milk, other dairy products,||
1505|031|H|red/dark-colored liquids, or alcohol. To prevent becoming||
1505|032|H|dehydrated, drink as much clear liquid as you can before, during,||
1505|033|H|and after drinking this medication. Try to drink not only water,||
1505|034|H|but also other types of clear liquids as directed by your doctor.||
1505|035|H|Follow your doctor's directions carefully.||
1505|036|H|   Take this product in 2 separate doses as directed by your||
1505|037|H|doctor. Carefully follow your doctor's directions for when to||
1505|038|H|take each dose. The dosage is based on your age and medical||
1505|039|H|condition.||
1505|040|H|   This product comes as either a powder in packets that must be||
1505|041|H|mixed with water before taking or as a liquid in bottles that is||
1505|042|H|ready to drink. Carefully follow the instructions for your||
1505|043|H|product. If you are using the powder packets, just before using,||
1505|044|H|mix each dose with 5 ounces/150 milliliters of cold water as||
1505|045|H|directed. Stir well until the powder dissolves completely (2 to 3||
1505|046|H|minutes), then drink all of it.||
1505|047|H|   If you have bloating or stomach/abdominal pain after taking||
1505|048|H|this product, it may help if you stop drinking clear liquids for||
1505|049|H|a little while or allow a longer time between each dose.||
1505|050|H|   Watery bowel movements usually begin 2 to 4 hours after you||
1505|051|H|drink the medication. This is normal and shows that the medicine||
1505|052|H|is working. You should have access to a toilet until the effects||
1505|053|H|of this medication have worn off.||
1505|054|H|   Do not take any other medications by mouth within 1 hour||
1505|055|H|before you start to drink this product because your body may not||
1505|056|H|absorb the other medications. Some medications (such as digoxin,||
1505|057|H|iron, tetracycline antibiotics, quinolone antibiotics such as||
1505|058|H|ciprofloxacin/levofloxacin, chlorpromazine, penicillamine) should||
1505|059|H|not be taken within 2 hours before or 6 hours after taking this||
1505|060|H|product. Ask your doctor or pharmacist when to take your other||
1505|061|H|medications.||
1505|062|B|||
1505|063|S|SIDE EFFECTS:  Frequent, very watery bowel movements at any time||
1505|064|S|should occur after you drink this product. Nausea, vomiting,||
1505|065|S|bloating, headache, or stomach/abdominal cramps may also occur.||
1505|066|S|If any of these effects last or get worse, tell your doctor or||
1505|067|S|pharmacist promptly.||
1505|068|S|   If your doctor has directed you to use this medication,||
1505|069|S|remember that your doctor has judged that the benefit to you is||
1505|070|S|greater than the risk of side effects. Many people using this||
1505|071|S|medication do not have serious side effects.||
1505|072|S|   This medication can cause your body to lose too much fluid and||
1505|073|S|salts (dehydration). Tell your doctor right away if you have any||
1505|074|S|of these serious side effects: confusion, severe dizziness,||
1505|075|S|fainting, fast/irregular heartbeat, seizure.||
1505|076|S|   Tell your doctor right away if you have any serious side||
1505|077|S|effects, including: stomach/abdominal pain that is severe or||
1505|078|S|doesn't go away, signs of kidney problems (such as change in the||
1505|079|S|amount of urine), bloody stools, rectal bleeding.||
1505|080|S|   A very serious allergic reaction to this drug is rare.||
1505|081|S|However, get medical help right away if you notice any symptoms||
1505|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1505|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1505|084|S|breathing.||
1505|085|S|   This is not a complete list of possible side effects. If you||
1505|086|S|notice other effects not listed above, contact your doctor or||
1505|087|S|pharmacist.||
1505|088|S|   In the US -||
1505|089|S|   Call your doctor for medical advice about side effects. You||
1505|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1505|091|S|www.fda.gov/medwatch.||
1505|092|S|   In Canada - Call your doctor for medical advice about side||
1505|093|S|effects. You may report side effects to Health Canada at||
1505|094|S|1-866-234-2345.||
1505|095|B|||
1505|096|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1505|097|P|pharmacist if you have any allergies. This product may contain||
1505|098|P|inactive ingredients, which can cause allergic reactions or other||
1505|099|P|problems. Talk to your pharmacist for more details.||
1505|100|P|   Before using this medication, tell your doctor or pharmacist||
1505|101|P|your medical history, especially of: heart problems (such as||
1505|102|P|irregular heartbeat, heart attack), kidney problems, salt/mineral||
1505|103|P|imbalance (such as low level of sodium in the blood), seizure,||
1505|104|P|stomach/intestinal problems (such as gastric retention, blockage,||
1505|105|P|ulcers, ulcerative colitis), trouble swallowing.||
1505|106|P|   Before having surgery, tell your doctor or dentist about all||
1505|107|P|the products you use (including prescription drugs,||
1505|108|P|nonprescription drugs, and herbal products).||
1505|109|P|   During pregnancy, this medication should be used only when||
1505|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
1505|111|P|   It is unknown if this product passes into breast milk. Consult||
1505|112|P|your doctor before breastfeeding.||
1505|113|B|||
1505|114|I|DRUG INTERACTIONS:  See also How to Use section.||
1505|115|I|   Drug interactions may change how your medications work or||
1505|116|I|increase your risk for serious side effects. This document does||
1505|117|I|not contain all possible drug interactions. Keep a list of all||
1505|118|I|the products you use (including prescription/nonprescription||
1505|119|I|drugs and herbal products) and share it with your doctor and||
1505|120|I|pharmacist. Do not start, stop, or change the dosage of any||
1505|121|I|medicines without your doctor's approval.||
1505|122|I|   Do not use other laxatives while taking this product.||
1505|123|B|||
1505|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1505|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1505|126|O|poison control center right away. US residents can call||
1505|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1505|128|B|||
1505|129|N|NOTES:  Do not share this medication with others.||
1505|130|N|   Lab tests (such as sodium/potassium blood levels, blood sugar||
1505|131|N|level) may be done before or after taking this medication. Keep||
1505|132|N|all medical and lab appointments. Consult your doctor for more||
1505|133|N|details.||
1505|134|B|||
1505|135|D|MISSED DOSE:  If you are unable to drink all of this product and||
1505|136|D|clear liquids as directed, call your doctor right away. Your||
1505|137|D|procedure may need to be rescheduled.||
1505|138|B|||
1505|139|R|STORAGE:  Store at room temperature away from light and moisture.||
1505|140|R|Do not store in the bathroom. Keep all medications away from||
1505|141|R|children and pets.||
1505|142|R|   Do not flush medications down the toilet or pour them into a||
1505|143|R|drain unless instructed to do so. Properly discard this product||
1505|144|R|when it is expired or no longer needed. Consult your pharmacist||
1505|145|R|or local waste disposal company.||
1505|146|B|||
1505|147|A|Information last revised May 2024.||
1505|148|A|Copyright(c) 2025 First Databank, Inc.||
1505|149|B|||
1506|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1506|002|Z|does NOT have all possible information about this product. This||
1506|003|Z|information does not assure that this product is safe, effective,||
1506|004|Z|or appropriate for you. This information is not individual||
1506|005|Z|medical advice and does not substitute for the advice of your||
1506|006|Z|health care professional. Always ask your health care||
1506|007|Z|professional for complete information about this product and your||
1506|008|Z|specific health needs.||
1506|009|B|||
1506|010|T|MORPHINE CONTROLLED-RELEASE CAPSULE - ORAL||
1506|011|F|(MOR-feen)||
1506|012|B|||
1506|013|W|WARNING:  Morphine has a risk for abuse and addiction, which can||
1506|014|W|lead to overdose and death. Morphine may also cause severe,||
1506|015|W|possibly fatal, breathing problems. To lower your risk, your||
1506|016|W|doctor should have you take the smallest dose of morphine that||
1506|017|W|works, and take it for the shortest possible time. See also How||
1506|018|W|to Use section for more information about addiction.||
1506|019|W|   Ask your doctor or pharmacist if you should have medication||
1506|020|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1506|021|W|Teach your family or household members about the signs of an||
1506|022|W|opioid overdose and how to treat it.||
1506|023|W|   The risk for severe breathing problems is higher when you||
1506|024|W|start this medication and after a dose increase, or if you take||
1506|025|W|the wrong dose/strength. Taking this medication with alcohol or||
1506|026|W|other drugs that can cause drowsiness or breathing problems may||
1506|027|W|cause very serious side effects, including death. Be sure you||
1506|028|W|know how to take morphine and what other drugs you should avoid||
1506|029|W|taking with it. See also Drug Interactions section. Get medical||
1506|030|W|help right away if any of these very serious side effects occur:||
1506|031|W|slow/shallow breathing, unusual lightheadedness, severe||
1506|032|W|drowsiness/dizziness, difficulty waking up.||
1506|033|W|   Do not break, crush, chew, or dissolve this medication. Taking||
1506|034|W|broken, crushed, chewed, or dissolved forms of controlled-release||
1506|035|W|morphine could cause a fatal overdose.||
1506|036|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1506|037|W|or abuse. If someone accidentally swallows this drug, get medical||
1506|038|W|help right away.||
1506|039|W|   Before using this medication, women of childbearing age should||
1506|040|W|talk with their doctor(s) about the risks and benefits. Tell your||
1506|041|W|doctor if you are pregnant or if you plan to become pregnant.||
1506|042|W|During pregnancy, this medication should be used only when||
1506|043|W|clearly needed. It may slightly increase the risk of birth||
1506|044|W|defects if used during the first two months of pregnancy. Also,||
1506|045|W|using it for a long time or in high doses near the expected||
1506|046|W|delivery date may harm the unborn baby. To lessen the risk, take||
1506|047|W|the smallest effective dose for the shortest possible time.||
1506|048|W|Babies born to mothers who use this drug for a long time may||
1506|049|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1506|050|W|doctor right away if you notice any symptoms in your newborn baby||
1506|051|W|such as crying that doesn't stop, slow/shallow breathing,||
1506|052|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1506|053|W|difficulty gaining weight.||
1506|054|B|||
1506|055|U|USES:  This medication is used to help relieve severe ongoing||
1506|056|U|pain (such as due to cancer). Morphine belongs to a class of||
1506|057|U|drugs known as opioid analgesics. It works in the brain to change||
1506|058|U|how your body feels and responds to pain.||
1506|059|U|   The higher strengths of this drug (100 or 200 milligrams per||
1506|060|U|capsule) should be used only if you have been regularly taking||
1506|061|U|moderate to large amounts of an opioid pain medication. These||
1506|062|U|strengths may cause overdose (even death) if taken by a person||
1506|063|U|who has not been regularly taking opioids.||
1506|064|U|   Do not use the controlled-release form of morphine to relieve||
1506|065|U|pain that is mild or that will go away in a few days. This||
1506|066|U|medication is not for occasional ("as needed") use.||
1506|067|B|||
1506|068|H|HOW TO USE:  See also Warning section.||
1506|069|H|   Read the Patient Information Leaflet if available from your||
1506|070|H|pharmacist before you start taking morphine and each time you get||
1506|071|H|a refill. If you have any questions, ask your doctor or||
1506|072|H|pharmacist.||
1506|073|H|   Take this medication on a regular schedule as directed by your||
1506|074|H|doctor, not as needed for sudden (breakthrough) pain. Take this||
1506|075|H|drug with or without food, usually 2 or 3 times daily (every 8 or||
1506|076|H|12 hours). If you have nausea, it may help to take this drug with||
1506|077|H|food. Ask your doctor or pharmacist about other ways to decrease||
1506|078|H|nausea (such as lying down for 1 to 2 hours with as little head||
1506|079|H|movement as possible). If nausea lasts, see your doctor.||
1506|080|H|   Swallow the capsules whole. Do not break, crush, chew, or||
1506|081|H|dissolve the capsule. Doing so can release all of the drug at||
1506|082|H|once, increasing the risk of morphine overdose.||
1506|083|H|   Adults who have trouble swallowing the capsule may open the||
1506|084|H|capsule and mix the contents in liquid or sprinkle on a spoonful||
1506|085|H|of soft food (such as applesauce). Swallow all of the drug/food||
1506|086|H|mixture right away without chewing. Then rinse your mouth and||
1506|087|H|swallow the rinse liquid to make sure that you have swallowed all||
1506|088|H|of the dose. Do not chew the mixture or prepare a supply in||
1506|089|H|advance. Do not give this medication to a child this way, since||
1506|090|H|they might chew the mixture and overdose. For children who have||
1506|091|H|trouble swallowing the capsule, ask the doctor about using a||
1506|092|H|different form of morphine instead.||
1506|093|H|   The dosage is based on your medical condition and response to||
1506|094|H|treatment. Do not increase your dose, take the medication more||
1506|095|H|often, or take it for a longer time than prescribed. Properly||
1506|096|H|stop the medication when so directed.||
1506|097|H|   Before you start taking this medication, ask your doctor or||
1506|098|H|pharmacist if you should stop or change how you use your other||
1506|099|H|opioid medication(s). Other pain relievers (such as||
1506|100|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1506|101|H|or pharmacist about using morphine safely with other drugs.||
1506|102|H|   Suddenly stopping this medication may cause withdrawal,||
1506|103|H|especially if you have used it for a long time or in high doses.||
1506|104|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1506|105|H|Tell your doctor or pharmacist right away if you have any||
1506|106|H|withdrawal symptoms such as restlessness, mental/mood changes||
1506|107|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1506|108|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1506|109|H|aches, or sudden changes in behavior.||
1506|110|H|   When this medication is used for a long time, it may not work||
1506|111|H|as well. Talk with your doctor if this medication stops working||
1506|112|H|well.||
1506|113|H|   Though it helps many people, this medication may sometimes||
1506|114|H|cause addiction. This risk may be higher if you have a||
1506|115|H|mental/mood disorder or a substance use disorder (such as overuse||
1506|116|H|of or addiction to drugs/alcohol). Take this medication exactly||
1506|117|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1506|118|H|pharmacist for more details.||
1506|119|H|   Tell your doctor if your pain does not get better or if it||
1506|120|H|gets worse, or if you have any new pain.||
1506|121|B|||
1506|122|S|SIDE EFFECTS:  See also Warning section.||
1506|123|S|   Nausea, vomiting, constipation, sweating, lightheadedness,||
1506|124|S|dizziness, or drowsiness may occur. Some of these side effects||
1506|125|S|may decrease after you have been using this medication for a||
1506|126|S|while. If any of these effects last or get worse, tell your||
1506|127|S|doctor or pharmacist promptly.||
1506|128|S|   To prevent constipation, eat dietary fiber, drink enough||
1506|129|S|water, and exercise. You may also need to take a laxative. Ask||
1506|130|S|your pharmacist which type of laxative is right for you.||
1506|131|S|   To reduce the risk of dizziness and lightheadedness, get up||
1506|132|S|slowly when rising from a sitting or lying position.||
1506|133|S|   Remember that this medication has been prescribed because your||
1506|134|S|doctor has judged that the benefit to you is greater than the||
1506|135|S|risk of side effects. Many people using this medication do not||
1506|136|S|have serious side effects.||
1506|137|S|   Tell your doctor right away if you have any serious side||
1506|138|S|effects, including: interrupted breathing during sleep (sleep||
1506|139|S|apnea), mental/mood changes (such as agitation, confusion,||
1506|140|S|hallucinations), severe stomach/abdominal pain, difficulty||
1506|141|S|urinating, signs of your adrenal glands not working well (such as||
1506|142|S|loss of appetite, unusual tiredness, weight loss), trouble||
1506|143|S|swallowing.||
1506|144|S|   Get medical help right away if you have any very serious side||
1506|145|S|effects, including: fainting, seizure, slow/shallow breathing,||
1506|146|S|severe drowsiness/difficulty waking up.||
1506|147|S|   A very serious allergic reaction to this drug is rare.||
1506|148|S|However, get medical help right away if you notice any symptoms||
1506|149|S|of a serious allergic reaction, including: rash, itching/swelling||
1506|150|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1506|151|S|breathing.||
1506|152|S|   This is not a complete list of possible side effects. If you||
1506|153|S|notice other effects not listed above, contact your doctor or||
1506|154|S|pharmacist.||
1506|155|S|   In the US -||
1506|156|S|   Call your doctor for medical advice about side effects. You||
1506|157|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1506|158|S|www.fda.gov/medwatch.||
1506|159|S|   In Canada - Call your doctor for medical advice about side||
1506|160|S|effects. You may report side effects to Health Canada at||
1506|161|S|1-866-234-2345.||
1506|162|B|||
1506|163|P|PRECAUTIONS:  Before taking morphine, tell your doctor or||
1506|164|P|pharmacist if you are allergic to it; or to other opioid pain||
1506|165|P|medications (such as codeine); or if you have any other||
1506|166|P|allergies. This product may contain inactive ingredients, which||
1506|167|P|can cause allergic reactions or other problems. Talk to your||
1506|168|P|pharmacist for more details.||
1506|169|P|   Before using this medication, tell your doctor or pharmacist||
1506|170|P|your medical history, especially of: brain disorders (such as||
1506|171|P|head injury, tumor, seizures), breathing problems (such as||
1506|172|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1506|173|P|kidney disease, liver disease, mental/mood disorders (such as||
1506|174|P|confusion, depression), personal or family history of a substance||
1506|175|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
1506|176|P|stomach/intestinal problems (such as blockage, constipation,||
1506|177|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
1506|178|P|(such as due to enlarged prostate), disease of the pancreas||
1506|179|P|(pancreatitis), gallbladder disease.||
1506|180|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1506|181|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1506|182|P|machinery, or do anything that needs alertness until you can do||
1506|183|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1506|184|P|are using marijuana (cannabis).||
1506|185|P|   Before having surgery, tell your doctor or dentist about all||
1506|186|P|the products you use (including prescription drugs,||
1506|187|P|nonprescription drugs, and herbal products).||
1506|188|P|   Older adults may be more sensitive to the effects of this||
1506|189|P|drug, especially dizziness, drowsiness, slow/shallow breathing,||
1506|190|P|or urinary problems.||
1506|191|P|   During pregnancy, this medication should be used only when||
1506|192|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1506|193|P|benefits with your doctor. (See also Warning section.)||
1506|194|P|   This drug passes into breast milk and may have undesirable||
1506|195|P|effects on a nursing infant. Tell the doctor right away if your||
1506|196|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1506|197|P|breathing. Consult your doctor before breastfeeding.||
1506|198|B|||
1506|199|I|DRUG INTERACTIONS:  See also Warning section.||
1506|200|I|   Drug interactions may change how your medications work or||
1506|201|I|increase your risk for serious side effects. This document does||
1506|202|I|not contain all possible drug interactions. Keep a list of all||
1506|203|I|the products you use (including prescription/nonprescription||
1506|204|I|drugs and herbal products) and share it with your doctor and||
1506|205|I|pharmacist. Do not start, stop, or change the dosage of any||
1506|206|I|medicines without your doctor's approval.||
1506|207|I|   Some products that may interact with this drug include:||
1506|208|I|certain pain medications (mixed opioid agonist/antagonists such||
1506|209|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1506|210|I|samidorphan.||
1506|211|I|   The risk of serious side effects (such as slow/shallow||
1506|212|I|breathing, severe drowsiness/dizziness) may be increased if this||
1506|213|I|medication is taken with other products that may also cause||
1506|214|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1506|215|I|if you are taking other products such as other opioid pain or||
1506|216|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1506|217|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1506|218|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1506|219|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1506|220|I|cetirizine, diphenhydramine).||
1506|221|I|   Check the labels on all your medicines (such as allergy or||
1506|222|I|cough-and-cold products) because they may contain ingredients||
1506|223|I|that cause drowsiness. Ask your pharmacist about using those||
1506|224|I|products safely.||
1506|225|I|   This medication may interfere with certain lab tests, possibly||
1506|226|I|causing false test results. Make sure lab personnel and all your||
1506|227|I|doctors know you use this drug.||
1506|228|B|||
1506|229|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1506|230|O|as passing out or trouble breathing, give them naloxone or||
1506|231|O|nalmefene if available, then call 911. If the person is awake and||
1506|232|O|has no symptoms, call a poison control center right away. US||
1506|233|O|residents can call 1-800-222-1222. Canada residents can call||
1506|234|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1506|235|O|breathing, slow heartbeat, coma.||
1506|236|B|||
1506|237|N|NOTES:  Do not share this medication with others. Sharing it is||
1506|238|N|against the law.||
1506|239|N|   This medication has been prescribed for your current condition||
1506|240|N|only. Do not use it later for another condition unless told to do||
1506|241|N|so by your doctor. A different medication may be necessary in||
1506|242|N|that case.||
1506|243|B|||
1506|244|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1506|245|D|remember. If it is near the time of the next dose, skip the||
1506|246|D|missed dose. Take your next dose at the regular time. Do not||
1506|247|D|double the dose to catch up.||
1506|248|B|||
1506|249|R|STORAGE:  Store at room temperature away from light and moisture.||
1506|250|R|Do not store in the bathroom. Keep all medications away from||
1506|251|R|children and pets.||
1506|252|R|   Do not flush medications down the toilet or pour them into a||
1506|253|R|drain unless instructed to do so. Properly discard this product||
1506|254|R|when it is expired or no longer needed. Consult your pharmacist||
1506|255|R|or local waste disposal company.||
1506|256|B|||
1506|257|A|Information last revised August 2025.||
1506|258|A|Copyright(c) 2025 First Databank, Inc.||
1506|259|B|||
1507|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1507|002|Z|does NOT have all possible information about this product. This||
1507|003|Z|information does not assure that this product is safe, effective,||
1507|004|Z|or appropriate for you. This information is not individual||
1507|005|Z|medical advice and does not substitute for the advice of your||
1507|006|Z|health care professional. Always ask your health care||
1507|007|Z|professional for complete information about this product and your||
1507|008|Z|specific health needs.||
1507|009|B|||
1507|010|T|LINACLOTIDE - ORAL||
1507|011|F|(lin-AK-loe-tide)||
1507|012|B|||
1507|013|C|COMMON BRAND NAME(S): Linzess||
1507|014|B|||
1507|015|W|WARNING:  This medication must not be used by children younger||
1507|016|W|than 2 years due to the risk for harm (especially serious||
1507|017|W|dehydration). Talk to your doctor for details.||
1507|018|B|||
1507|019|U|USES:  See also Warning section.||
1507|020|U|   Linaclotide is used to treat certain types of bowel problems||
1507|021|U|(irritable bowel syndrome with constipation, chronic idiopathic||
1507|022|U|constipation, functional constipation). It works by increasing||
1507|023|U|fluid in your intestines and helping speed up movement of food||
1507|024|U|through the gut. Linaclotide may improve stool texture and lessen||
1507|025|U|symptoms such as bloating, abdominal pain/discomfort, straining,||
1507|026|U|and feelings of incomplete bowel movements.||
1507|027|B|||
1507|028|H|HOW TO USE:  Read the Medication Guide provided by your||
1507|029|H|pharmacist before you start taking linaclotide and each time you||
1507|030|H|get a refill. If you have any questions, ask your doctor or||
1507|031|H|pharmacist.||
1507|032|H|   Take this medication by mouth as directed by your doctor,||
1507|033|H|usually once daily on an empty stomach, at least 30 minutes||
1507|034|H|before a meal. Swallow the capsules whole. Do not break or chew||
1507|035|H|the capsules.||
1507|036|H|   If you have trouble swallowing the capsule, it may be opened||
1507|037|H|and the contents mixed in a teaspoonful of applesauce. Swallow||
1507|038|H|the mixture right away, without chewing it. Do not save the||
1507|039|H|mixture for future use.||
1507|040|H|   You may also empty the capsule's content into an ounce (30||
1507|041|H|milliliters) of water. Swirl the mixture for 20 seconds and drink||
1507|042|H|right away, without chewing it. Add another ounce (30||
1507|043|H|milliliters) of water to the cup, swirl for 20 seconds and drink||
1507|044|H|right away to get your whole dose. The water mixture may also be||
1507|045|H|given through a tube into the stomach (nasogastric or gastric||
1507|046|H|tube). If you are giving this medication through a tube, ask your||
1507|047|H|health care professional for detailed instructions on how to give||
1507|048|H|it.||
1507|049|H|   The dosage is based on your medical condition and response to||
1507|050|H|treatment.||
1507|051|H|   Use this medication regularly to get the most benefit from it.||
1507|052|H|To help you remember, take it at the same time each day.||
1507|053|H|   Tell your doctor if your condition does not get better or if||
1507|054|H|it gets worse.||
1507|055|B|||
1507|056|S|SIDE EFFECTS:  Diarrhea, bloating, gas, or stomach/abdominal||
1507|057|S|pain/discomfort may occur. If any of these effects last or get||
1507|058|S|worse, tell your doctor or pharmacist promptly.||
1507|059|S|   Remember that this medication has been prescribed because your||
1507|060|S|doctor has judged that the benefit to you is greater than the||
1507|061|S|risk of side effects. Many people using this medication do not||
1507|062|S|have serious side effects.||
1507|063|S|   Stop taking this medication and tell your doctor right away if||
1507|064|S|you have any serious side effects, including: severe diarrhea.||
1507|065|S|   A very serious allergic reaction to this drug is rare.||
1507|066|S|However, get medical help right away if you notice any symptoms||
1507|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1507|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1507|069|S|breathing.||
1507|070|S|   This is not a complete list of possible side effects. If you||
1507|071|S|notice other effects not listed above, contact your doctor or||
1507|072|S|pharmacist.||
1507|073|S|   In the US -||
1507|074|S|   Call your doctor for medical advice about side effects. You||
1507|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1507|076|S|www.fda.gov/medwatch.||
1507|077|S|   In Canada - Call your doctor for medical advice about side||
1507|078|S|effects. You may report side effects to Health Canada at||
1507|079|S|1-866-234-2345.||
1507|080|B|||
1507|081|P|PRECAUTIONS:  Before taking linaclotide, tell your doctor or||
1507|082|P|pharmacist if you are allergic to it; or if you have any other||
1507|083|P|allergies. This product may contain inactive ingredients, which||
1507|084|P|can cause allergic reactions or other problems. Talk to your||
1507|085|P|pharmacist for more details.||
1507|086|P|   Before using this medication, tell your doctor or pharmacist||
1507|087|P|your medical history, especially of: stomach/intestinal blockage.||
1507|088|P|   Before having surgery, tell your doctor or dentist about all||
1507|089|P|the products you use (including prescription drugs,||
1507|090|P|nonprescription drugs, and herbal products).||
1507|091|P|   During pregnancy, this medication should be used only when||
1507|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
1507|093|P|   It is unknown if this medication passes into breast milk.||
1507|094|P|Consult your doctor before breastfeeding.||
1507|095|B|||
1507|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1507|097|I|medications work or increase your risk for serious side effects.||
1507|098|I|This document does not contain all possible drug interactions.||
1507|099|I|Keep a list of all the products you use (including||
1507|100|I|prescription/nonprescription drugs and herbal products) and share||
1507|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
1507|102|I|the dosage of any medicines without your doctor's approval.||
1507|103|I|   A product that may interact with this drug is: pramlintide.||
1507|104|B|||
1507|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1507|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1507|107|O|poison control center right away. US residents can call||
1507|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1507|109|B|||
1507|110|N|NOTES:  Do not share this medication with others.||
1507|111|B|||
1507|112|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1507|113|D|next dose at the regular time. Do not double the dose to catch||
1507|114|D|up.||
1507|115|B|||
1507|116|R|STORAGE:  Store in the original container at room temperature||
1507|117|R|away from light and moisture. Do not store in the bathroom. Keep||
1507|118|R|the drying agent (desiccant) in the container. Tightly close the||
1507|119|R|container when not in use. Keep all medications away from||
1507|120|R|children and pets.||
1507|121|R|   Do not flush medications down the toilet or pour them into a||
1507|122|R|drain unless instructed to do so. Properly discard this product||
1507|123|R|when it is expired or no longer needed. Consult your pharmacist||
1507|124|R|or local waste disposal company.||
1507|125|B|||
1507|126|A|Information last revised October 2024.||
1507|127|A|Copyright(c) 2025 First Databank, Inc.||
1507|128|B|||
1508|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1508|002|Z|does NOT have all possible information about this product. This||
1508|003|Z|information does not assure that this product is safe, effective,||
1508|004|Z|or appropriate for you. This information is not individual||
1508|005|Z|medical advice and does not substitute for the advice of your||
1508|006|Z|health care professional. Always ask your health care||
1508|007|Z|professional for complete information about this product and your||
1508|008|Z|specific health needs.||
1508|009|B|||
1508|010|T|OMACETAXINE - SUBCUTANEOUS INJECTION||
1508|011|F|(OH-ma-se-TAX-een)||
1508|012|B|||
1508|013|C|COMMON BRAND NAME(S): Synribo||
1508|014|B|||
1508|015|U|USES:  This medication is used to treat a certain type of cancer||
1508|016|U|(chronic myeloid leukemia-CML). It works by slowing or stopping||
1508|017|U|the growth of cancer cells.||
1508|018|B|||
1508|019|H|HOW TO USE:  Read the Medication Guide and the Instructions for||
1508|020|H|Use Leaflet provided by your pharmacist before you start using||
1508|021|H|omacetaxine and each time you get a refill. Ask your health care||
1508|022|H|professional how to prepare and use this medication. If you have||
1508|023|H|any questions, ask your doctor or pharmacist.||
1508|024|H|   Inject this medication under the skin as directed by your||
1508|025|H|doctor, usually twice a day (every 12 hours) for 7 to 14 days.||
1508|026|H|This cycle should be repeated every 28 days as directed by your||
1508|027|H|doctor. The injection is given in the thigh, upper arm, or||
1508|028|H|stomach area. The dosage is based on your medical condition, body||
1508|029|H|size, labs, and response to treatment. Do not increase your dose||
1508|030|H|or use this medication more often than prescribed. Your condition||
1508|031|H|will not improve any faster, and the risk of serious side effects||
1508|032|H|will increase.||
1508|033|H|   You should wear gloves and protective eyewear when handling||
1508|034|H|and using this product. Before using, check this product for||
1508|035|H|particles or discoloration. If either is present, do not use the||
1508|036|H|liquid. Before injecting each dose, clean the skin you are going||
1508|037|H|to inject into (the injection site) with rubbing alcohol. Change||
1508|038|H|the injection site each time to lessen injury under the skin. Do||
1508|039|H|not inject into skin that is bruised, hard, red, tender, or have||
1508|040|H|scars or stretch marks. To lessen bruising, do not rub the||
1508|041|H|injection site after a shot. Learn how to store and discard||
1508|042|H|medical supplies safely.||
1508|043|H|   If this medication touches your skin, wash your skin right||
1508|044|H|away and completely with soap and water. If this medication gets||
1508|045|H|in your eyes, flush the eyes with water right away. Call your||
1508|046|H|doctor afterwards for further instructions.||
1508|047|B|||
1508|048|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, constipation,||
1508|049|S|abdominal pain, weakness, headache, difficulty sleeping,||
1508|050|S|nosebleed, tiredness, loss of appetite, and pain at the injection||
1508|051|S|site may occur. If any of these effects last or get worse, tell||
1508|052|S|your doctor or pharmacist promptly.||
1508|053|S|   Temporary hair loss may occur. Normal hair growth should||
1508|054|S|return after treatment has ended.||
1508|055|S|   People using this medication may have serious side effects.||
1508|056|S|However, you have been prescribed this drug because your doctor||
1508|057|S|has judged that the benefit to you is greater than the risk of||
1508|058|S|side effects. Careful monitoring by your doctor may decrease your||
1508|059|S|risk.||
1508|060|S|   Tell your doctor right away if you have any serious side||
1508|061|S|effects, including: swelling hands/ankles/feet, joint/back pain.||
1508|062|S|   This medication decreases bone marrow function, an effect that||
1508|063|S|may lead to a low number of blood cells such as red cells, white||
1508|064|S|cells, and platelets. This effect can cause anemia, decrease your||
1508|065|S|body's ability to fight an infection, or cause easy||
1508|066|S|bruising/bleeding. This may make you more likely to get a serious||
1508|067|S|(rarely fatal) infection or make any infection you have worse.||
1508|068|S|Tell your doctor right away if you develop any of the following||
1508|069|S|symptoms: unusual tiredness, rapid breathing, easy||
1508|070|S|bruising/bleeding, signs of infection (such as sore throat that||
1508|071|S|doesn't go away, fever, chills).||
1508|072|S|   This drug may rarely cause serious (rarely fatal) bleeding in||
1508|073|S|the brain or bleeding from the stomach or intestines. If you||
1508|074|S|notice any of the following serious side effects, get medical||
1508|075|S|help right away: stomach/abdominal pain that doesn't go away,||
1508|076|S|black stools, vomit that looks like coffee grounds,||
1508|077|S|dizziness/fainting, sudden vision changes, confusion, trouble||
1508|078|S|speaking.||
1508|079|S|   This medication may rarely make your blood sugar rise, which||
1508|080|S|can cause or worsen diabetes. Tell your doctor right away if you||
1508|081|S|have symptoms of high blood sugar such as increased||
1508|082|S|thirst/urination. If you already have diabetes, check your blood||
1508|083|S|sugar regularly as directed and share the results with your||
1508|084|S|doctor. Your doctor may need to adjust your diabetes medication,||
1508|085|S|exercise program, or diet.||
1508|086|S|   Omacetaxine can commonly cause a rash that is usually not||
1508|087|S|serious. However, you may not be able to tell it apart from a||
1508|088|S|rare rash that could be a sign of a severe reaction. Tell your||
1508|089|S|doctor right away if you develop any rash.||
1508|090|S|   A very serious allergic reaction to this drug is rare.||
1508|091|S|However, get medical help right away if you notice any symptoms||
1508|092|S|of a serious allergic reaction, including: rash, itching/swelling||
1508|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1508|094|S|breathing.||
1508|095|S|   This is not a complete list of possible side effects. If you||
1508|096|S|notice other effects not listed above, contact your doctor or||
1508|097|S|pharmacist.||
1508|098|S|   In the US -||
1508|099|S|   Call your doctor for medical advice about side effects. You||
1508|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1508|101|S|www.fda.gov/medwatch.||
1508|102|S|   In Canada - Call your doctor for medical advice about side||
1508|103|S|effects. You may report side effects to Health Canada at||
1508|104|S|1-866-234-2345.||
1508|105|B|||
1508|106|P|PRECAUTIONS:  Before using omacetaxine, tell your doctor or||
1508|107|P|pharmacist if you are allergic to it; or if you have any other||
1508|108|P|allergies. This product may contain inactive ingredients, which||
1508|109|P|can cause allergic reactions or other problems. Talk to your||
1508|110|P|pharmacist for more details.||
1508|111|P|   Before using this medication, tell your doctor or pharmacist||
1508|112|P|your medical history, especially of: diabetes, bleeding problems,||
1508|113|P|current/recent infections.||
1508|114|P|   Omacetaxine can make you more likely to get infections or may||
1508|115|P|make current infections worse. Stay away from anyone who has an||
1508|116|P|infection that may easily spread (such as chickenpox, COVID-19,||
1508|117|P|measles, flu). Talk to your doctor if you have been exposed to an||
1508|118|P|infection or for more details.||
1508|119|P|   Tell your health care professional that you are using||
1508|120|P|omacetaxine before having any immunizations/vaccinations. Avoid||
1508|121|P|contact with people who have recently received live vaccines||
1508|122|P|(such as flu vaccine inhaled through the nose).||
1508|123|P|   To lower the chance of getting cut, bruised, or injured, use||
1508|124|P|caution with sharp objects like razors and nail cutters, and||
1508|125|P|avoid activities such as contact sports.||
1508|126|P|   This drug may make you tired. Alcohol or marijuana (cannabis)||
1508|127|P|can make you more tired. Do not drive, use machinery, or do||
1508|128|P|anything that needs alertness until you can do it safely. Limit||
1508|129|P|alcoholic beverages. Talk to your doctor if you are using||
1508|130|P|marijuana (cannabis).||
1508|131|P|   Before having surgery, tell your doctor or dentist about all||
1508|132|P|the products you use (including prescription drugs,||
1508|133|P|nonprescription drugs, and herbal products).||
1508|134|P|   Older adults may be more sensitive to the side effects of this||
1508|135|P|drug, especially easy bruising/bleeding, bleeding from the||
1508|136|P|stomach or intestines, unusual tiredness, signs of infection||
1508|137|P|(such as sore throat that doesn't go away, fever, chills, cough).||
1508|138|P|   Tell your doctor if you are pregnant or plan to become||
1508|139|P|pregnant. You should not become pregnant while using omacetaxine.||
1508|140|P|Omacetaxine may harm an unborn baby. Your doctor should order a||
1508|141|P|pregnancy test before you start this medication. Women using this||
1508|142|P|medication should ask about reliable forms of birth control||
1508|143|P|during treatment and for 6 months after the last dose. Men using||
1508|144|P|this medication should ask about reliable forms of birth control||
1508|145|P|during treatment and for 3 months after the last dose. If you or||
1508|146|P|your partner becomes pregnant, talk to your doctor right away||
1508|147|P|about the risks and benefits of this medication.||
1508|148|P|   It is unknown if this drug passes into breast milk. Because of||
1508|149|P|the possible risk to the infant, breastfeeding is not recommended||
1508|150|P|while using this drug and for 2 weeks after the last dose.||
1508|151|P|Consult your doctor before breastfeeding.||
1508|152|B|||
1508|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1508|154|I|medications work or increase your risk for serious side effects.||
1508|155|I|This document does not contain all possible drug interactions.||
1508|156|I|Keep a list of all the products you use (including||
1508|157|I|prescription/nonprescription drugs and herbal products) and share||
1508|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
1508|159|I|the dosage of any medicines without your doctor's approval.||
1508|160|I|   Some products that may interact with this drug include: other||
1508|161|I|drugs that can cause bleeding/bruising (including antiplatelet||
1508|162|I|drugs such as clopidogrel, NSAIDs such as ibuprofen or naproxen,||
1508|163|I|"blood thinners" such as warfarin or dabigatran).||
1508|164|I|   Aspirin can increase the risk of bleeding when used with this||
1508|165|I|medication. However, if your doctor has told you to take low-dose||
1508|166|I|aspirin to prevent heart attack or stroke (usually 81-162||
1508|167|I|milligrams a day), you should keep taking the aspirin unless your||
1508|168|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1508|169|I|details.||
1508|170|B|||
1508|171|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1508|172|O|has overdosed and has serious symptoms such as passing out or||
1508|173|O|trouble breathing, call 911. Otherwise, call a poison control||
1508|174|O|center right away. US residents can call 1-800-222-1222. Canada||
1508|175|O|residents can call 1-844-764-7669.||
1508|176|B|||
1508|177|N|NOTES:  Do not share this medication with others.||
1508|178|N|   Lab and/or medical tests (such as complete blood count, blood||
1508|179|N|glucose) should be done while you are using this medication. Keep||
1508|180|N|all medical and lab appointments. Consult your doctor for more||
1508|181|N|details.||
1508|182|B|||
1508|183|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1508|184|D|next dose at the regular time. Do not double the dose to catch||
1508|185|D|up.||
1508|186|B|||
1508|187|R|STORAGE:  Store in the refrigerator (or with ice packs and/or in||
1508|188|R|a cooler when transporting the medication). When stored in the||
1508|189|R|refrigerator, this medication expires 6 days from when it was||
1508|190|R|first mixed by the health care professional. If stored at room||
1508|191|R|temperature, this medication expires 12 hours from when it was||
1508|192|R|first mixed by the health care professional. Keep all medications||
1508|193|R|away from children and pets.||
1508|194|R|   Do not flush medications down the toilet or pour them into a||
1508|195|R|drain unless instructed to do so. Properly discard this product||
1508|196|R|when it is expired or no longer needed. Read the Medication||
1508|197|R|Guide/Instructions for Use Leaflet for details. Consult your||
1508|198|R|pharmacist or local waste disposal company.||
1508|199|B|||
1508|200|M|MEDICAL ALERT:  Your condition can cause complications in a||
1508|201|M|medical emergency. For information about enrolling in MedicAlert,||
1508|202|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1508|203|B|||
1508|204|A|Information last revised April 2025.||
1508|205|A|Copyright(c) 2025 First Databank, Inc.||
1508|206|B|||
1509|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1509|002|Z|does NOT have all possible information about this product. This||
1509|003|Z|information does not assure that this product is safe, effective,||
1509|004|Z|or appropriate for you. This information is not individual||
1509|005|Z|medical advice and does not substitute for the advice of your||
1509|006|Z|health care professional. Always ask your health care||
1509|007|Z|professional for complete information about this product and your||
1509|008|Z|specific health needs.||
1509|009|B|||
1509|010|T|TOFACITINIB - ORAL||
1509|011|F|(TOE-fa-SYE-ti-nib)||
1509|012|B|||
1509|013|C|COMMON BRAND NAME(S): Xeljanz||
1509|014|B|||
1509|015|W|WARNING:  Tofacitinib may lower your ability to fight infections.||
1509|016|W|This may make you more likely to get a serious (rarely fatal)||
1509|017|W|infection or make any infection you have worse. The most common||
1509|018|W|serious infections include pneumonia, skin infections, shingles,||
1509|019|W|a certain bowel disease (diverticulitis), swelling of the||
1509|020|W|appendix (appendicitis), and urinary tract infections. The risk||
1509|021|W|for infections may be higher if you also take other drugs that||
1509|022|W|suppress the immune system (such as cyclosporine, tacrolimus).||
1509|023|W|Tell your doctor right away if you have any signs of infection||
1509|024|W|(such as a sore throat that doesn't go away, fever, chills,||
1509|025|W|cough, trouble breathing, painful/frequent urination, non-healing||
1509|026|W|skin sores).||
1509|027|W|   You should have a tuberculosis (TB) skin test before and||
1509|028|W|during treatment with this medication. Tell your doctor if you||
1509|029|W|have been near someone with tuberculosis or have lived or||
1509|030|W|traveled in areas where certain fungal infections (such as||
1509|031|W|coccidioidomycosis, histoplasmosis) are common. These areas||
1509|032|W|include the Ohio and Mississippi River valleys and the||
1509|033|W|southwestern United States.||
1509|034|W|   Though it is very unlikely to occur, there may be a risk of||
1509|035|W|developing cancer (such as lymphoma, skin cancer, lung cancer)||
1509|036|W|with this medication. Your risk may be higher if you are a||
1509|037|W|current or past smoker. Tell your doctor right away if you||
1509|038|W|develop symptoms such as fever or cough that doesn't go away,||
1509|039|W|wheezing, unusual lumps/growths, unexplained weight loss, night||
1509|040|W|sweats, change in appearance or size of moles, or unusual skin||
1509|041|W|changes.||
1509|042|W|   Tofacitinib may cause serious (possibly fatal) problems from||
1509|043|W|blood clots (such as heart attack, stroke, blood clots in the||
1509|044|W|lungs or legs). You may be at an increased risk for blood clots||
1509|045|W|if you are a current or past smoker, or are 50 years of age or||
1509|046|W|older and have at least one risk factor for heart disease.||
1509|047|W|Discuss the risks and benefits of treatment with your doctor. Get||
1509|048|W|medical help right away if any of these side effects occur:||
1509|049|W|shortness of breath/rapid breathing, chest/jaw/left arm pain,||
1509|050|W|unusual sweating, confusion, sudden dizziness/fainting,||
1509|051|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1509|052|W|trouble speaking, weakness on one side of the body, or sudden||
1509|053|W|vision changes.||
1509|054|W|   In patients with a kidney transplant who are also taking other||
1509|055|W|drugs that suppress the immune system, there may also be a risk||
1509|056|W|of developing a certain white blood cell disorder (Epstein Barr||
1509|057|W|Virus-associated post-transplant lymphoproliferative disorder)||
1509|058|W|with this medication. Discuss the risks and benefits of treatment||
1509|059|W|with your doctor.||
1509|060|B|||
1509|061|U|USES:  Tofacitinib is used to treat certain types of arthritis||
1509|062|U|(such as psoriatic arthritis, rheumatoid arthritis, ankylosing||
1509|063|U|spondylitis, polyarticular course juvenile idiopathic||
1509|064|U|arthritis-pcJIA). It helps to decrease pain/tenderness/swelling||
1509|065|U|in the joints. Tofacitinib is also used to treat a certain bowel||
1509|066|U|disease (ulcerative colitis). It helps to reduce symptoms of||
1509|067|U|ulcerative colitis such as diarrhea, rectal bleeding, and stomach||
1509|068|U|pain.||
1509|069|B|||
1509|070|V|OTHER USES:  This section contains uses of this drug that are not||
1509|071|V|listed in the approved professional labeling for the drug but||
1509|072|V|that may be prescribed by your health care professional. Use this||
1509|073|V|drug for a condition that is listed in this section only if it||
1509|074|V|has been so prescribed by your health care professional.||
1509|075|V|   This medication may also be used for COVID-19, but is only||
1509|076|V|effective in hospitalized patients who need supplemental oxygen||
1509|077|V|or a mechanical ventilator to breathe.||
1509|078|B|||
1509|079|H|HOW TO USE:  Read the Medication Guide provided by your||
1509|080|H|pharmacist before you start taking tofacitinib and each time you||
1509|081|H|get a refill. If you are using the liquid form of this||
1509|082|H|medication, also read the Instructions for Use. If you have any||
1509|083|H|questions, ask your doctor or pharmacist.||
1509|084|H|   Take this medication by mouth with or without food as directed||
1509|085|H|by your doctor, usually once or twice daily.||
1509|086|H|   If you are using the liquid form of this medication, carefully||
1509|087|H|measure the dose using a special measuring device/spoon. Do not||
1509|088|H|use a household spoon because you may not get the correct dose.||
1509|089|H|   The dosage is based on your medical condition, response to||
1509|090|H|treatment, lab tests, and other medications you may be taking. Be||
1509|091|H|sure to tell your doctor and pharmacist about all the products||
1509|092|H|you use (including prescription drugs, nonprescription drugs, and||
1509|093|H|herbal products). Children's dosage is also based on weight. Do||
1509|094|H|not increase your dose or use this drug more often or for longer||
1509|095|H|than prescribed. Your condition will not improve any faster, and||
1509|096|H|your risk of serious side effects will increase.||
1509|097|H|   Take this medication regularly to get the most benefit from||
1509|098|H|it. Remember to take it at the same time(s) each day.||
1509|099|H|   Tell your doctor if your condition does not get better or if||
1509|100|H|it gets worse.||
1509|101|B|||
1509|102|S|SIDE EFFECTS:  See also Warning section.||
1509|103|S|   Headache or diarrhea may occur. If either of these effects||
1509|104|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
1509|105|S|   People using this medication may have serious side effects.||
1509|106|S|However, you have been prescribed this drug because your doctor||
1509|107|S|has judged that the benefit to you is greater than the risk of||
1509|108|S|side effects. Careful monitoring by your doctor may decrease your||
1509|109|S|risk.||
1509|110|S|   Tell your doctor right away if you have any serious side||
1509|111|S|effects, including: unusual tiredness, fast heartbeat, signs of||
1509|112|S|liver disease (such as nausea/vomiting that doesn't stop, loss of||
1509|113|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1509|114|S|urine).||
1509|115|S|   A very serious allergic reaction to this drug is rare.||
1509|116|S|However, get medical help right away if you notice any symptoms||
1509|117|S|of a serious allergic reaction, including: rash, itching/swelling||
1509|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1509|119|S|breathing.||
1509|120|S|   This is not a complete list of possible side effects. If you||
1509|121|S|notice other effects not listed above, contact your doctor or||
1509|122|S|pharmacist.||
1509|123|S|   In the US -||
1509|124|S|   Call your doctor for medical advice about side effects. You||
1509|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1509|126|S|www.fda.gov/medwatch.||
1509|127|S|   In Canada - Call your doctor for medical advice about side||
1509|128|S|effects. You may report side effects to Health Canada at||
1509|129|S|1-866-234-2345.||
1509|130|B|||
1509|131|P|PRECAUTIONS:  See also Warning section.||
1509|132|P|   Before taking tofacitinib, tell your doctor or pharmacist if||
1509|133|P|you are allergic to it; or if you have any other allergies. This||
1509|134|P|product may contain inactive ingredients, which can cause||
1509|135|P|allergic reactions or other problems. Talk to your pharmacist for||
1509|136|P|more details.||
1509|137|P|   Before using this medication, tell your doctor or pharmacist||
1509|138|P|your medical history, especially of: blood clots (such as in the||
1509|139|P|lungs, legs), blood/bone marrow disorders (such as anemia, low||
1509|140|P|lymphocyte/neutrophil count), cancer, heart problems (such as||
1509|141|P|previous heart attack), kidney disease, liver disease (such as||
1509|142|P|hepatitis B or C), lung disease, past/recent/current infections||
1509|143|P|(such as tuberculosis, herpes zoster, HIV infection), current or||
1509|144|P|past smoking, other stomach/intestinal disorders (such as ulcers,||
1509|145|P|diverticulitis), stroke.||
1509|146|P|   Tofacitinib can make you more likely to get infections or may||
1509|147|P|make current infections worse. Stay away from anyone who has an||
1509|148|P|infection that may easily spread (such as chickenpox, COVID-19,||
1509|149|P|measles, flu). Talk to your doctor if you have been exposed to an||
1509|150|P|infection or for more details.||
1509|151|P|   Tell your health care professional that you are using||
1509|152|P|tofacitinib before having any immunizations/vaccinations. Avoid||
1509|153|P|contact with people who have recently received live vaccines||
1509|154|P|(such as flu vaccine inhaled through the nose).||
1509|155|P|   Liquid products may contain sugar and/or aspartame. Liquid||
1509|156|P|products may also contain alcohol. Caution is advised if you have||
1509|157|P|diabetes, liver disease, phenylketonuria (PKU), or any other||
1509|158|P|condition that requires you to limit/avoid these substances in||
1509|159|P|your diet. Ask your doctor or pharmacist about using this product||
1509|160|P|safely.||
1509|161|P|   Before having surgery, tell your doctor or dentist about all||
1509|162|P|the products you use (including prescription drugs,||
1509|163|P|nonprescription drugs, and herbal products).||
1509|164|P|   Older adults may be at greater risk for infections while using||
1509|165|P|this drug.||
1509|166|P|   During pregnancy, this medication should be used only when||
1509|167|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1509|168|P|benefits with your doctor.||
1509|169|P|   This medication passes into breast milk. Because of the||
1509|170|P|possible risk to the infant, breastfeeding is not recommended||
1509|171|P|while using this medication and for at least 18 hours after the||
1509|172|P|last dose. Consult your doctor before breastfeeding.||
1509|173|B|||
1509|174|I|DRUG INTERACTIONS:  See also Warning section.||
1509|175|I|   Drug interactions may change how your medications work or||
1509|176|I|increase your risk for serious side effects. This document does||
1509|177|I|not contain all possible drug interactions. Keep a list of all||
1509|178|I|the products you use (including prescription/nonprescription||
1509|179|I|drugs and herbal products) and share it with your doctor and||
1509|180|I|pharmacist. Do not start, stop, or change the dosage of any||
1509|181|I|medicines without your doctor's approval.||
1509|182|I|   Other medications can affect the removal of tofacitinib from||
1509|183|I|your body, which may affect how tofacitinib works. Examples||
1509|184|I|include rifampin, among others.||
1509|185|B|||
1509|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1509|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1509|188|O|poison control center right away. US residents can call||
1509|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1509|190|B|||
1509|191|N|NOTES:  Do not share this medication with others.||
1509|192|N|   Lab and/or medical tests (such as liver/kidney function,||
1509|193|N|complete blood count, cholesterol levels, skin exams) should be||
1509|194|N|done while you are using this medication. Keep all medical and||
1509|195|N|lab appointments.||
1509|196|B|||
1509|197|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1509|198|D|remember. If it is near the time of the next dose, skip the||
1509|199|D|missed dose. Take your next dose at the regular time. Do not||
1509|200|D|double the dose to catch up.||
1509|201|B|||
1509|202|R|STORAGE:  Store at room temperature away from light and moisture.||
1509|203|R|Do not store in the bathroom. Keep all medications away from||
1509|204|R|children and pets.||
1509|205|R|   Store the liquid form in the original bottle. Keep the bottle||
1509|206|R|in the carton to protect from light. Once the bottle is opened,||
1509|207|R|this medication expires after 60 days.||
1509|208|R|   Do not flush medications down the toilet or pour them into a||
1509|209|R|drain unless instructed to do so. Properly discard this product||
1509|210|R|when it is expired or no longer needed. Consult your pharmacist||
1509|211|R|or local waste disposal company.||
1509|212|B|||
1509|213|M|MEDICAL ALERT:  Your condition can cause complications in a||
1509|214|M|medical emergency. For information about enrolling in MedicAlert,||
1509|215|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1509|216|B|||
1509|217|A|Information last revised November 2025.||
1509|218|A|Copyright(c) 2025 First Databank, Inc.||
1509|219|B|||
1510|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1510|002|Z|does NOT have all possible information about this product. This||
1510|003|Z|information does not assure that this product is safe, effective,||
1510|004|Z|or appropriate for you. This information is not individual||
1510|005|Z|medical advice and does not substitute for the advice of your||
1510|006|Z|health care professional. Always ask your health care||
1510|007|Z|professional for complete information about this product and your||
1510|008|Z|specific health needs.||
1510|009|B|||
1510|010|T|BROMOCRIPTINE (DIABETES) - ORAL||
1510|011|F|(BROE-moe-KRIP-teen)||
1510|012|B|||
1510|013|C|COMMON BRAND NAME(S): Cycloset||
1510|014|B|||
1510|015|U|USES:  This medication is used with a proper diet and exercise||
1510|016|U|program to control high blood sugar in people with type 2||
1510|017|U|diabetes.||
1510|018|U|   Bromocriptine is an ergot medication that is believed to make||
1510|019|U|your body's insulin function better, improving blood sugar||
1510|020|U|control.||
1510|021|U|   Controlling high blood sugar helps prevent kidney damage,||
1510|022|U|blindness, nerve problems, loss of limbs, and sexual function||
1510|023|U|problems. Proper control of diabetes may also lessen your risk of||
1510|024|U|a heart attack or stroke.||
1510|025|B|||
1510|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1510|027|H|from your pharmacist before you start taking bromocriptine and||
1510|028|H|each time you get a refill. If you have any questions, ask your||
1510|029|H|doctor or pharmacist.||
1510|030|H|   Take this medication by mouth with food as directed by your||
1510|031|H|doctor, usually once a day. It should be taken within 2 hours||
1510|032|H|after waking in the morning. To reduce your risk of side effects,||
1510|033|H|your doctor may direct you to start this medication at a low dose||
1510|034|H|and gradually increase your dose. This medication often causes||
1510|035|H|dizziness, especially just after the first dose or anytime your||
1510|036|H|dose is increased. To reduce the risk of injury from falling, sit||
1510|037|H|or lie down immediately after taking your first dose or anytime||
1510|038|H|your dose is increased or if you feel dizzy.||
1510|039|H|   Do not switch between different brands of bromocriptine unless||
1510|040|H|directed by your doctor. The other brands may not have the same||
1510|041|H|effect on blood sugar control.||
1510|042|H|   The dosage is based on your medical condition and response to||
1510|043|H|treatment.||
1510|044|H|   Take this medication regularly to get the most benefit from||
1510|045|H|it. To help you remember, take it at the same time each day.||
1510|046|H|   Tell your doctor if your condition does not get better or if||
1510|047|H|it gets worse (your blood sugar is too high or too low).||
1510|048|B|||
1510|049|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, constipation,||
1510|050|S|dizziness, drowsiness, headache, heartburn, runny nose, and||
1510|051|S|weakness may occur. If any of these effects last or get worse,||
1510|052|S|tell your doctor or pharmacist promptly.||
1510|053|S|   Remember that this medication has been prescribed because your||
1510|054|S|doctor has judged that the benefit to you is greater than the||
1510|055|S|risk of side effects. Many people using this medication do not||
1510|056|S|have serious side effects.||
1510|057|S|   This medication can cause low blood sugar (hypoglycemia). This||
1510|058|S|may occur if you do not get enough calories from food or if you||
1510|059|S|do unusually heavy exercise. Symptoms of low blood sugar include||
1510|060|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
1510|061|S|dizziness, or tingling hands/feet. It is a good habit to carry||
1510|062|S|glucose tablets or gel to treat low blood sugar. If you don't||
1510|063|S|have these reliable forms of glucose, rapidly raise your blood||
1510|064|S|sugar by eating a quick source of sugar such as table sugar,||
1510|065|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
1510|066|S|doctor right away about the reaction and the use of this product.||
1510|067|S|To help prevent low blood sugar, eat meals on a regular schedule,||
1510|068|S|and do not skip meals. Check with your doctor or pharmacist to||
1510|069|S|find out what you should do if you miss a meal.||
1510|070|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1510|071|S|thirst/urination. If these symptoms occur, tell your doctor right||
1510|072|S|away. Your doctor may need to adjust your diabetes medication,||
1510|073|S|exercise program, or diet.||
1510|074|S|   Some people taking bromocriptine have reported falling asleep||
1510|075|S|suddenly during their usual daily activities (such as talking on||
1510|076|S|the phone, driving). In some cases, sleep occurred without any||
1510|077|S|feelings of drowsiness beforehand. You should not drive or take||
1510|078|S|part in other possibly dangerous activities until you are certain||
1510|079|S|that this medication will not cause drowsiness or sudden sleep.||
1510|080|S|If you experience increased sleepiness or fall asleep during the||
1510|081|S|day, do not drive or take part in other possibly dangerous||
1510|082|S|activities until you have discussed this effect with your doctor.||
1510|083|S|Your risk is increased with use of alcohol or other medications||
1510|084|S|that can make you drowsy.||
1510|085|S|   You may also develop a sudden drop in blood pressure. This||
1510|086|S|effect can cause dizziness, nausea, and fainting. A drop in blood||
1510|087|S|pressure is more likely when you are first starting the||
1510|088|S|medication, when your dose is increased, or when you get up||
1510|089|S|suddenly. To lower your risk, get up slowly from a sitting or||
1510|090|S|lying position.||
1510|091|S|   Tell your doctor right away if you have any serious side||
1510|092|S|effects, including: vision problems (such as blurred/double||
1510|093|S|vision), mental/mood changes (such as depression, confusion,||
1510|094|S|hallucinations, restlessness).||
1510|095|S|   A very serious allergic reaction to this drug is rare.||
1510|096|S|However, get medical help right away if you notice any symptoms||
1510|097|S|of a serious allergic reaction, including: rash, itching/swelling||
1510|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1510|099|S|breathing.||
1510|100|S|   This is not a complete list of possible side effects. If you||
1510|101|S|notice other effects not listed above, contact your doctor or||
1510|102|S|pharmacist.||
1510|103|S|   In the US -||
1510|104|S|   Call your doctor for medical advice about side effects. You||
1510|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1510|106|S|www.fda.gov/medwatch.||
1510|107|S|   In Canada - Call your doctor for medical advice about side||
1510|108|S|effects. You may report side effects to Health Canada at||
1510|109|S|1-866-234-2345.||
1510|110|B|||
1510|111|P|PRECAUTIONS:  Before taking bromocriptine, tell your doctor or||
1510|112|P|pharmacist if you are allergic to it; or to other ergot||
1510|113|P|medications (such as ergonovine, pergolide); or if you have any||
1510|114|P|other allergies. This product may contain inactive ingredients,||
1510|115|P|which can cause allergic reactions or other problems. Talk to||
1510|116|P|your pharmacist for more details.||
1510|117|P|   Before using this medication, tell your doctor or pharmacist||
1510|118|P|your medical history, especially of: migraine headaches that||
1510|119|P|cause fainting, mental/mood disorders (such as depression,||
1510|120|P|psychosis, schizophrenia, dementia), high blood pressure, recent||
1510|121|P|pregnancy (especially with high blood pressure).||
1510|122|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1510|123|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1510|124|P|machinery, or do anything that needs alertness until you can do||
1510|125|P|it safely. Limit alcoholic beverages while taking this medication||
1510|126|P|because it can also increase your risk of developing low blood||
1510|127|P|sugar. Talk to your doctor if you are using marijuana (cannabis).||
1510|128|P|   It may be harder to control your blood sugar when your body is||
1510|129|P|stressed (such as due to fever, infection, injury, or surgery).||
1510|130|P|Consult your doctor because this may require a change in your||
1510|131|P|treatment plan, medications, or blood sugar testing.||
1510|132|P|   Before having surgery, tell your doctor or dentist about all||
1510|133|P|the products you use (including prescription drugs,||
1510|134|P|nonprescription drugs, and herbal products).||
1510|135|P|   During pregnancy, this medication should be used only when||
1510|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
1510|137|P|This medication should not be used in women who have recently||
1510|138|P|given birth due to risk of serious side effects.||
1510|139|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1510|140|P|your doctor for managing your blood sugar while pregnant. Your||
1510|141|P|doctor may change your diabetes treatment during your pregnancy||
1510|142|P|(such as diet and medications including insulin).||
1510|143|P|   It is unknown if this medication passes into breast milk.||
1510|144|P|Breastfeeding is not recommended while using this drug. Consult||
1510|145|P|your doctor before breastfeeding.||
1510|146|B|||
1510|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1510|148|I|medications work or increase your risk for serious side effects.||
1510|149|I|This document does not contain all possible drug interactions.||
1510|150|I|Keep a list of all the products you use (including||
1510|151|I|prescription/nonprescription drugs and herbal products) and share||
1510|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
1510|153|I|the dosage of any medicines without your doctor's approval.||
1510|154|I|   Other medications can affect the removal of bromocriptine from||
1510|155|I|your body, which may affect how bromocriptine works. Examples||
1510|156|I|include cimetidine, cobicistat, telithromycin, azole antifungals||
1510|157|I|(such as ketoconazole), macrolide antibiotics (such as||
1510|158|I|erythromycin), rifamycins (such as rifabutin), St. John's wort,||
1510|159|I|among others.||
1510|160|I|   Tell your doctor or pharmacist if you are taking other||
1510|161|I|products that cause drowsiness including alcohol, marijuana||
1510|162|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1510|163|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1510|164|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1510|165|I|codeine), psychiatric medicines (such as chlorpromazine,||
1510|166|I|risperidone, amitriptyline, trazodone).||
1510|167|I|   Check the labels on all your medicines (such as allergy or||
1510|168|I|cough-and-cold products) because they may contain ingredients||
1510|169|I|that cause drowsiness. Ask your pharmacist about using those||
1510|170|I|products safely.||
1510|171|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1510|172|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1510|173|I|heartbeat you would usually feel when your blood sugar falls too||
1510|174|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1510|175|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1510|176|I|   Many drugs can affect your blood sugar, making it harder to||
1510|177|I|control. Before you start, stop, or change any medication, talk||
1510|178|I|with your doctor or pharmacist about how the medication may||
1510|179|I|affect your blood sugar. Check your blood sugar regularly as||
1510|180|I|directed and share the results with your doctor. Tell your doctor||
1510|181|I|right away if you have symptoms of high or low blood sugar. (See||
1510|182|I|also Side Effects section.) Your doctor may need to adjust your||
1510|183|I|diabetes medication, exercise program, or diet.||
1510|184|B|||
1510|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1510|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1510|187|O|poison control center right away. US residents can call||
1510|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1510|189|B|||
1510|190|N|NOTES:  Do not share this medication with others.||
1510|191|N|   Attend a diabetes education program to learn more about how to||
1510|192|N|manage your diabetes with medications, diet, exercise, and||
1510|193|N|regular medical exams.||
1510|194|N|   Learn the symptoms of high and low blood sugar and how to||
1510|195|N|treat low blood sugar. Check your blood sugar regularly as||
1510|196|N|directed.||
1510|197|N|   Lab and/or medical tests (such as blood pressure, eye exams,||
1510|198|N|kidney/liver function) should be done while you are taking this||
1510|199|N|medication. Keep all medical and lab appointments. Consult your||
1510|200|N|doctor for more details.||
1510|201|B|||
1510|202|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1510|203|D|remember. If it is more than 2 hours after waking, skip the||
1510|204|D|missed dose. Take your next dose at the regular time the next||
1510|205|D|morning. Do not double the dose to catch up.||
1510|206|B|||
1510|207|R|STORAGE:  Store at room temperature away from light and moisture.||
1510|208|R|Do not store in the bathroom. Keep all medications away from||
1510|209|R|children and pets.||
1510|210|R|   Do not flush medications down the toilet or pour them into a||
1510|211|R|drain unless instructed to do so. Properly discard this product||
1510|212|R|when it is expired or no longer needed. Consult your pharmacist||
1510|213|R|or local waste disposal company.||
1510|214|B|||
1510|215|M|MEDICAL ALERT:  Your condition can cause complications in a||
1510|216|M|medical emergency. For information about enrolling in MedicAlert,||
1510|217|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1510|218|B|||
1510|219|A|Information last revised November 2025.||
1510|220|A|Copyright(c) 2025 First Databank, Inc.||
1510|221|B|||
1511|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1511|002|Z|does NOT have all possible information about this product. This||
1511|003|Z|information does not assure that this product is safe, effective,||
1511|004|Z|or appropriate for you. This information is not individual||
1511|005|Z|medical advice and does not substitute for the advice of your||
1511|006|Z|health care professional. Always ask your health care||
1511|007|Z|professional for complete information about this product and your||
1511|008|Z|specific health needs.||
1511|009|B|||
1511|010|T|ICOSAPENT ETHYL - ORAL||
1511|011|F|(eye-KOE-sa-pent ETH-il)||
1511|012|B|||
1511|013|C|COMMON BRAND NAME(S): Vascepa||
1511|014|B|||
1511|015|U|USES:  Icosapent ethyl is used along with certain other||
1511|016|U|cholesterol medications ("statins" such as atorvastatin,||
1511|017|U|simvastatin) to reduce the risk of heart attack, stroke, and||
1511|018|U|certain types of heart problems that require treatment in a||
1511|019|U|hospital. It is also used along with a proper diet to help lower||
1511|020|U|fats (triglycerides) in the blood. Icosapent ethyl is a type of||
1511|021|U|omega-3 fatty acid, a fat found in fish oil. It is thought to||
1511|022|U|work by decreasing the amount of triglycerides made by the body.||
1511|023|U|   In addition to eating a proper diet (such as a||
1511|024|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
1511|025|U|help this medication work better include exercising, losing||
1511|026|U|weight if overweight, and stopping smoking. Consult your doctor||
1511|027|U|for more details.||
1511|028|B|||
1511|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1511|030|H|from your pharmacist before you start taking icosapent ethyl and||
1511|031|H|each time you get a refill. If you have any questions, ask your||
1511|032|H|doctor or pharmacist.||
1511|033|H|   Take this medication by mouth with food as directed by your||
1511|034|H|doctor, usually twice a day. Swallow the capsules whole. Do not||
1511|035|H|crush, chew, open, or dissolve the capsules.||
1511|036|H|   Do not substitute other omega-3 fatty acids or fish oil||
1511|037|H|products (such as nonprescription products, vitamins,||
1511|038|H|supplements) for this product without talking with your doctor||
1511|039|H|first. They may not contain the same amount and type of fatty||
1511|040|H|acids.||
1511|041|H|   Take this medication regularly to get the most benefit from||
1511|042|H|it. To help you remember, take it at the same times each day.||
1511|043|H|Keep taking this medication even if you feel well.||
1511|044|H|   It is very important to continue to follow your doctor's||
1511|045|H|advice about diet and exercise.||
1511|046|B|||
1511|047|S|SIDE EFFECTS:  Joint/muscle pain or constipation may occur. If||
1511|048|S|any of these effects last or get worse, tell your doctor or||
1511|049|S|pharmacist promptly.||
1511|050|S|   Remember that this medication has been prescribed because your||
1511|051|S|doctor has judged that the benefit to you is greater than the||
1511|052|S|risk of side effects. Many people using this medication do not||
1511|053|S|have serious side effects.||
1511|054|S|   Tell your doctor right away if you have any serious side||
1511|055|S|effects, including: fast/irregular heartbeat, easy||
1511|056|S|bruising/bleeding, swelling ankles/feet/hands.||
1511|057|S|   A very serious allergic reaction to this drug is rare.||
1511|058|S|However, get medical help right away if you notice any symptoms||
1511|059|S|of a serious allergic reaction, including: rash, itching/swelling||
1511|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1511|061|S|breathing.||
1511|062|S|   This is not a complete list of possible side effects. If you||
1511|063|S|notice other effects not listed above, contact your doctor or||
1511|064|S|pharmacist.||
1511|065|S|   In the US -||
1511|066|S|   Call your doctor for medical advice about side effects. You||
1511|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1511|068|S|www.fda.gov/medwatch.||
1511|069|S|   In Canada - Call your doctor for medical advice about side||
1511|070|S|effects. You may report side effects to Health Canada at||
1511|071|S|1-866-234-2345.||
1511|072|B|||
1511|073|P|PRECAUTIONS:  Before taking icosapent ethyl, tell your doctor or||
1511|074|P|pharmacist if you are allergic to it; or to fish or shellfish||
1511|075|P|products; or if you have any other allergies. This product may||
1511|076|P|contain inactive ingredients, which can cause allergic reactions||
1511|077|P|or other problems. Talk to your pharmacist for more details.||
1511|078|P|   Before using this medication, tell your doctor or pharmacist||
1511|079|P|your medical history, especially of: liver disease, irregular||
1511|080|P|heartbeat (such as atrial fibrillation).||
1511|081|P|   Before having surgery, tell your doctor or dentist about all||
1511|082|P|the products you use (including prescription drugs,||
1511|083|P|nonprescription drugs, and herbal products).||
1511|084|P|   During pregnancy, this medication should be used only when||
1511|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
1511|086|P|   This medication passes into breast milk. Consult your doctor||
1511|087|P|before breastfeeding.||
1511|088|B|||
1511|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1511|090|I|medications work or increase your risk for serious side effects.||
1511|091|I|This document does not contain all possible drug interactions.||
1511|092|I|Keep a list of all the products you use (including||
1511|093|I|prescription/nonprescription drugs and herbal products) and share||
1511|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
1511|095|I|the dosage of any medicines without your doctor's approval.||
1511|096|B|||
1511|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1511|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1511|099|O|poison control center right away. US residents can call||
1511|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1511|101|B|||
1511|102|N|NOTES:  Do not share this medication with others.||
1511|103|N|   Lab and/or medical tests (such as cholesterol/triglyceride||
1511|104|N|levels) should be done while you are taking this medication. Keep||
1511|105|N|all medical and lab appointments. Consult your doctor for more||
1511|106|N|details.||
1511|107|B|||
1511|108|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1511|109|D|remember. If it is near the time of the next dose, skip the||
1511|110|D|missed dose. Take your next dose at the regular time. Do not||
1511|111|D|double the dose to catch up.||
1511|112|B|||
1511|113|R|STORAGE:  Store at room temperature away from light and moisture.||
1511|114|R|Keep all medications away from children and pets.||
1511|115|R|   Do not flush medications down the toilet or pour them into a||
1511|116|R|drain unless instructed to do so. Properly discard this product||
1511|117|R|when it is expired or no longer needed. Consult your pharmacist||
1511|118|R|or local waste disposal company.||
1511|119|B|||
1511|120|A|Information last revised May 2024.||
1511|121|A|Copyright(c) 2025 First Databank, Inc.||
1511|122|B|||
1512|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1512|002|Z|does NOT have all possible information about this product. This||
1512|003|Z|information does not assure that this product is safe, effective,||
1512|004|Z|or appropriate for you. This information is not individual||
1512|005|Z|medical advice and does not substitute for the advice of your||
1512|006|Z|health care professional. Always ask your health care||
1512|007|Z|professional for complete information about this product and your||
1512|008|Z|specific health needs.||
1512|009|B|||
1512|010|T|MICONAZOLE CREAM AND FLUCONAZOLE CAPSULE - KIT||
1512|011|F|(mye-KON-a-zole/floo-KON-a-zole)||
1512|012|B|||
1512|013|U|USES:  This product contains 2 medications: one fluconazole||
1512|014|U|capsule and a tube of miconazole cream. Both are used to treat||
1512|015|U|vaginal yeast infections. They work by stopping the growth of||
1512|016|U|vaginal yeast (fungus). Fluconazole is taken by mouth to clear||
1512|017|U|the infection. Miconazole cream is used on the skin around the||
1512|018|U|vaginal area to reduce symptoms such as burning and itching.||
1512|019|U|These medications belong to a class of drugs known as azole||
1512|020|U|antifungals.||
1512|021|U|   This product is available without a prescription. Before using||
1512|022|U|this over-the-counter product to self-treat, talk to your doctor||
1512|023|U|if this is your first vaginal yeast infection, if this is your||
1512|024|U|second infection within 2 months, or if you are considering||
1512|025|U|treatment for a girl under 12 years old.||
1512|026|U|   Vaginal yeast infections do not cause fever, chills,||
1512|027|U|stomach/abdominal pain, or vaginal discharge with a bad odor. If||
1512|028|U|you have these symptoms, do not use this product. Contact your||
1512|029|U|doctor right away because these may be signs of a more serious||
1512|030|U|infection.||
1512|031|U|   Check the ingredients on the label even if you have used the||
1512|032|U|product before. The manufacturer may have changed the||
1512|033|U|ingredients. Also, products with similar names may contain||
1512|034|U|different ingredients meant for different purposes. Taking the||
1512|035|U|wrong product could harm you.||
1512|036|B|||
1512|037|H|HOW TO USE:  Before using this product, read all directions on||
1512|038|H|the product package and the Patient Information Leaflet. Ask your||
1512|039|H|doctor or pharmacist if you have any questions. If your doctor||
1512|040|H|has prescribed this medication, use it as directed.||
1512|041|H|   Take the fluconazole capsule by mouth usually as a single||
1512|042|H|dose, with or without food at any time of the day, or as directed||
1512|043|H|by your doctor.||
1512|044|H|   Apply a small amount of the miconazole cream to the vaginal||
1512|045|H|area and rub it in gently, usually twice daily to relieve||
1512|046|H|burning/itching, or as directed by your doctor. Wash your hands||
1512|047|H|before and after use. Avoid getting the cream in your eyes. If||
1512|048|H|this occurs, wash your eyes right away with plenty of water.||
1512|049|H|   Your condition should start to improve within 1 day of taking||
1512|050|H|the fluconazole. The effect of the fluconazole continues for||
1512|051|H|several days. Tell your doctor if your condition does not get||
1512|052|H|better after 3 days, if symptoms last more than 7 days, or if you||
1512|053|H|get another yeast infection within 2 months. If you think you may||
1512|054|H|have a serious medical problem, get medical help right away.||
1512|055|B|||
1512|056|S|SIDE EFFECTS:  Nausea, stomach/abdominal pain, or headache may||
1512|057|S|occur with fluconazole. Diarrhea and dizziness may rarely occur||
1512|058|S|with fluconazole. Miconazole cream may cause mild burning,||
1512|059|S|itching, or redness. If any of these effects last or get worse,||
1512|060|S|tell your doctor or pharmacist promptly.||
1512|061|S|   If your doctor has directed you to use this medication,||
1512|062|S|remember that your doctor has judged that the benefit to you is||
1512|063|S|greater than the risk of side effects. Many people using this||
1512|064|S|medication do not have serious side effects.||
1512|065|S|   Get medical help right away if you have any very serious side||
1512|066|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1512|067|S|fainting.||
1512|068|S|   This drug may rarely cause serious liver disease. Get medical||
1512|069|S|help right away if you develop any symptoms of liver disease,||
1512|070|S|including: nausea/vomiting that doesn't stop, severe||
1512|071|S|stomach/abdominal pain, yellowing eyes/skin, dark urine, unusual||
1512|072|S|tiredness.||
1512|073|S|   A very serious allergic reaction to this drug is rare.||
1512|074|S|However, get medical help right away if you notice any symptoms||
1512|075|S|of a serious allergic reaction, including: fever, swollen lymph||
1512|076|S|nodes, rash, itching/swelling (especially of the||
1512|077|S|face/tongue/throat), severe dizziness, trouble breathing.||
1512|078|S|   This is not a complete list of possible side effects. If you||
1512|079|S|notice other effects not listed above, contact your doctor or||
1512|080|S|pharmacist.||
1512|081|S|   In the US -||
1512|082|S|   Call your doctor for medical advice about side effects. You||
1512|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1512|084|S|www.fda.gov/medwatch.||
1512|085|S|   In Canada - Call your doctor for medical advice about side||
1512|086|S|effects. You may report side effects to Health Canada at||
1512|087|S|1-866-234-2345.||
1512|088|B|||
1512|089|P|PRECAUTIONS:  Before using miconazole/fluconazole, tell your||
1512|090|P|doctor or pharmacist if you are allergic to either of these||
1512|091|P|drugs; or to other azole antifungal drugs (such as clotrimazole,||
1512|092|P|itraconazole, ketoconazole); or if you have any other allergies.||
1512|093|P|This product may contain inactive ingredients, which can cause||
1512|094|P|allergic reactions or other problems. Talk to your pharmacist for||
1512|095|P|more details.||
1512|096|P|   Before using this medication, tell your doctor or pharmacist||
1512|097|P|your medical history, especially of: liver disease, kidney||
1512|098|P|disease.||
1512|099|P|   Fluconazole may cause a condition that affects the heart||
1512|100|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1512|101|P|serious (rarely fatal) fast/irregular heartbeat and other||
1512|102|P|symptoms (such as severe dizziness, fainting) that need medical||
1512|103|P|attention right away.||
1512|104|P|   The risk of QT prolongation may be increased if you have||
1512|105|P|certain medical conditions or are taking other drugs that may||
1512|106|P|cause QT prolongation. Before using fluconazole, tell your doctor||
1512|107|P|or pharmacist of all the drugs you take and if you have any of||
1512|108|P|the following conditions: certain heart problems (heart failure,||
1512|109|P|slow heartbeat, QT prolongation in the EKG), family history of||
1512|110|P|certain heart problems (QT prolongation in the EKG, sudden||
1512|111|P|cardiac death).||
1512|112|P|   Low levels of potassium or magnesium in the blood may also||
1512|113|P|increase your risk of QT prolongation. This risk may increase if||
1512|114|P|you use certain drugs (such as diuretics/"water pills") or if you||
1512|115|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1512|116|P|Talk to your doctor about using fluconazole safely.||
1512|117|P|   Fluconazole may rarely make you dizzy. Alcohol or marijuana||
1512|118|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
1512|119|P|or do anything that needs alertness until you can do it safely.||
1512|120|P|Limit alcoholic beverages. Talk to your doctor if you are using||
1512|121|P|marijuana (cannabis).||
1512|122|P|   Before having surgery, tell your doctor or dentist about all||
1512|123|P|the products you use (including prescription drugs,||
1512|124|P|nonprescription drugs, and herbal products).||
1512|125|P|   Older adults may be more sensitive to the side effects of this||
1512|126|P|drug, especially QT prolongation (see above).||
1512|127|P|   During pregnancy, this medication should be used only when||
1512|128|P|clearly needed. Fluconazole may harm an unborn baby if taken||
1512|129|P|during the first 3 months of pregnancy. Discuss the risks and||
1512|130|P|benefits with your doctor.||
1512|131|P|   Fluconazole passes into breast milk. It is unknown if||
1512|132|P|miconazole passes into breast milk. However, these drugs are||
1512|133|P|unlikely to harm a nursing infant. Consult your doctor before||
1512|134|P|breastfeeding.||
1512|135|B|||
1512|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1512|137|I|medications work or increase your risk for serious side effects.||
1512|138|I|This document does not contain all possible drug interactions.||
1512|139|I|Keep a list of all the products you use (including||
1512|140|I|prescription/nonprescription drugs and herbal products) and share||
1512|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
1512|142|I|the dosage of any medicines without your doctor's approval.||
1512|143|I|   A product that may interact with this drug is: clopidogrel.||
1512|144|I|   Many drugs besides fluconazole may affect the heart rhythm (QT||
1512|145|I|prolongation), including pimozide, quinidine, macrolide||
1512|146|I|antibiotics (such as erythromycin), among others.||
1512|147|I|   Fluconazole can slow down the removal of other medications||
1512|148|I|from your body, which can affect how they work. Examples of||
1512|149|I|affected drugs include abrocitinib, deuruxolitinib, domperidone,||
1512|150|I|flibanserin, lemborexant, macitentan, mavacamten, nirogacestat,||
1512|151|I|rilzabrutinib, taletrectinib, among others.||
1512|152|B|||
1512|153|O|OVERDOSE:  The cream may be harmful if swallowed. If someone has||
1512|154|O|overdosed and has serious symptoms such as passing out or trouble||
1512|155|O|breathing, call 911. Otherwise, call a poison control center||
1512|156|O|right away. US residents can call 1-800-222-1222. Canada||
1512|157|O|residents can call 1-844-764-7669.||
1512|158|B|||
1512|159|N|NOTES:  Not applicable.||
1512|160|B|||
1512|161|D|MISSED DOSE:  Not applicable.||
1512|162|B|||
1512|163|R|STORAGE:  Store the capsule at room temperature away from light||
1512|164|R|and moisture. Do not store in the bathroom. Store the cream at||
1512|165|R|room temperature. Keep all medications away from children and||
1512|166|R|pets.||
1512|167|R|   Do not flush medications down the toilet or pour them into a||
1512|168|R|drain unless instructed to do so. Properly discard this product||
1512|169|R|when it is expired or no longer needed. Consult your pharmacist||
1512|170|R|or local waste disposal company.||
1512|171|B|||
1512|172|A|Information last revised September 2025.||
1512|173|A|Copyright(c) 2025 First Databank, Inc.||
1512|174|B|||
1514|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1514|002|Z|does NOT have all possible information about this product. This||
1514|003|Z|information does not assure that this product is safe, effective,||
1514|004|Z|or appropriate for you. This information is not individual||
1514|005|Z|medical advice and does not substitute for the advice of your||
1514|006|Z|health care professional. Always ask your health care||
1514|007|Z|professional for complete information about this product and your||
1514|008|Z|specific health needs.||
1514|009|B|||
1514|010|T|PONATINIB - ORAL||
1514|011|F|(poe-NA-ti-nib)||
1514|012|B|||
1514|013|C|COMMON BRAND NAME(S): Iclusig||
1514|014|B|||
1514|015|W|WARNING:  Ponatinib has caused serious (sometimes fatal) problems||
1514|016|W|from blood clots (such as heart attack, stroke, blood clots in||
1514|017|W|the lungs or legs). Get medical help right away if you have:||
1514|018|W|chest/jaw/left arm pain, unusual sweating, confusion, trouble||
1514|019|W|speaking, weakness on one side of the body, sudden/severe||
1514|020|W|headaches, sudden dizziness/fainting, sudden vision changes,||
1514|021|W|shortness of breath/rapid breathing, pain/swelling/warmth in the||
1514|022|W|groin/calf.||
1514|023|W|   This medication can cause very serious (possibly fatal) heart||
1514|024|W|failure. Tell your doctor right away if you develop symptoms of||
1514|025|W|heart failure, including shortness of breath, swelling||
1514|026|W|ankles/feet, unusual tiredness, unusual/sudden weight gain.||
1514|027|W|   Ponatinib can also rarely cause very serious (possibly fatal)||
1514|028|W|liver disease. Your doctor will order blood tests to check your||
1514|029|W|liver before you start and while you are taking ponatinib. Tell||
1514|030|W|your doctor right away if you develop symptoms of liver disease,||
1514|031|W|including nausea/vomiting that doesn't stop, stomach/abdominal||
1514|032|W|pain, dark urine, yellowing eyes/skin. Your doctor may need to||
1514|033|W|change your dosage or discontinue the drug.||
1514|034|B|||
1514|035|U|USES:  Ponatinib is used to treat certain types of blood cancer||
1514|036|U|(chronic myelogenous leukemia-CML, acute lymphoblastic||
1514|037|U|leukemia-ALL). It works by slowing or stopping the growth of||
1514|038|U|cancer cells. It belongs to a class of drugs known as kinase||
1514|039|U|inhibitors.||
1514|040|B|||
1514|041|H|HOW TO USE:  Read the Medication Guide provided by your||
1514|042|H|pharmacist before you start taking ponatinib and each time you||
1514|043|H|get a refill. If you have any questions, ask your doctor or||
1514|044|H|pharmacist.||
1514|045|H|   Take this medication by mouth with or without food as directed||
1514|046|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
1514|047|H|not crush, break, cut, chew, or dissolve the tablets. Drink||
1514|048|H|plenty of fluids unless otherwise directed by your doctor. The||
1514|049|H|dosage is based on your medical condition, lab results, response||
1514|050|H|to treatment, and other medications you may be taking. Be sure to||
1514|051|H|tell your doctor and pharmacist about all the products you use||
1514|052|H|(including prescription drugs, nonprescription drugs, and herbal||
1514|053|H|products).||
1514|054|H|   Do not increase your dose or take this medication more often||
1514|055|H|than directed. Your condition will not improve any faster, and||
1514|056|H|your risk of side effects will increase.||
1514|057|H|   Use this medication regularly to get the most benefit from it.||
1514|058|H|To help you remember, take it at the same time each day.||
1514|059|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1514|060|H|using this medication unless your doctor or pharmacist says you||
1514|061|H|may do so safely. Grapefruit can increase the chance of side||
1514|062|H|effects with this medicine. Ask your doctor or pharmacist for||
1514|063|H|more details.||
1514|064|H|   Medications that reduce stomach acid (such as antacids, proton||
1514|065|H|pump inhibitors/PPIs, H2 blockers) may make ponatinib work less||
1514|066|H|well. Ask your doctor or pharmacist for more details.||
1514|067|H|   Since this drug can be absorbed through the skin and lungs and||
1514|068|H|may harm an unborn baby, women who are pregnant or who may become||
1514|069|H|pregnant should not handle this medication or breathe the dust||
1514|070|H|from the tablets.||
1514|071|B|||
1514|072|S|SIDE EFFECTS:  See also Warning section.||
1514|073|S|   Headache, dizziness, constipation, or loss of appetite may||
1514|074|S|occur. If any of these effects last or get worse, tell your||
1514|075|S|doctor or pharmacist immediately.||
1514|076|S|   People using this medication may have serious side effects.||
1514|077|S|However, you have been prescribed this drug because your doctor||
1514|078|S|has judged that the benefit to you is greater than the risk of||
1514|079|S|side effects. Careful monitoring by your doctor may decrease your||
1514|080|S|risk.||
1514|081|S|   Tell your doctor right away if you have any serious side||
1514|082|S|effects, including: weight gain, numb/tingling skin,||
1514|083|S|pain/numbness/burning feeling in fingers/toes, fainting,||
1514|084|S|fast/slow/irregular/pounding heartbeat, eye||
1514|085|S|pain/swelling/irritation, slow wound healing, sudden severe||
1514|086|S|headache, blurred vision/vision problems, problems thinking.||
1514|087|S|   Ponatinib sometimes causes side effects due to the rapid||
1514|088|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1514|089|S|risk, your doctor may add a medication and tell you to drink||
1514|090|S|plenty of fluids. Tell your doctor right away if you have||
1514|091|S|symptoms such as: signs of kidney problems (such as painful||
1514|092|S|urination, pink/bloody urine, change in the amount of urine),||
1514|093|S|muscle spasms/weakness.||
1514|094|S|   Get medical help right away if you have any very serious side||
1514|095|S|effects, including: sudden/severe back pain, unusual||
1514|096|S|bleeding/bruising, black/bloody stools, vomit that contains blood||
1514|097|S|or looks like coffee grounds, shortness of breath, seizures.||
1514|098|S|   This medication may raise your blood pressure. Check your||
1514|099|S|blood pressure regularly and tell your doctor if the results are||
1514|100|S|high. Your doctor may control your blood pressure with||
1514|101|S|medication.||
1514|102|S|   This medication may lower your ability to fight infections.||
1514|103|S|This may make you more likely to get a serious infection or make||
1514|104|S|any infection you have worse. Tell your doctor right away if have||
1514|105|S|any signs of infection (such as sore throat that doesn't go away,||
1514|106|S|fever, chills).||
1514|107|S|   A very serious allergic reaction to this drug is rare.||
1514|108|S|However, get medical help right away if you notice any symptoms||
1514|109|S|of a serious allergic reaction, including: rash, itching/swelling||
1514|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1514|111|S|breathing.||
1514|112|S|   This is not a complete list of possible side effects. If you||
1514|113|S|notice other effects not listed above, contact your doctor or||
1514|114|S|pharmacist.||
1514|115|S|   In the US -||
1514|116|S|   Call your doctor for medical advice about side effects. You||
1514|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1514|118|S|www.fda.gov/medwatch.||
1514|119|S|   In Canada - Call your doctor for medical advice about side||
1514|120|S|effects. You may report side effects to Health Canada at||
1514|121|S|1-866-234-2345.||
1514|122|B|||
1514|123|P|PRECAUTIONS:  Before taking ponatinib, tell your doctor or||
1514|124|P|pharmacist if you are allergic to it; or if you have any other||
1514|125|P|allergies. This product may contain inactive ingredients, which||
1514|126|P|can cause allergic reactions or other problems. Talk to your||
1514|127|P|pharmacist for more details.||
1514|128|P|   Before using this medication, tell your doctor or pharmacist||
1514|129|P|your medical history, especially of: liver disease, heart||
1514|130|P|problems (such as history of heart attack, angina, high blood||
1514|131|P|pressure), previous stroke or "mini-stroke" (transient ischemic||
1514|132|P|attack), blood vessel problems (such as an aneurysm or a||
1514|133|P|tear/break in the aorta or other blood vessels), diabetes, high||
1514|134|P|cholesterol, tobacco use.||
1514|135|P|   This drug may make you dizzy or blur your vision. Alcohol or||
1514|136|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
1514|137|P|machinery, or do anything that needs alertness or clear vision||
1514|138|P|until you can do it safely. Limit alcoholic beverages. Talk to||
1514|139|P|your doctor if you are using marijuana (cannabis).||
1514|140|P|   Before having surgery, tell your doctor or dentist about all||
1514|141|P|the products you use (including prescription drugs,||
1514|142|P|nonprescription drugs, and herbal products).||
1514|143|P|   This medication may cause wounds to heal slowly or poorly.||
1514|144|P|Your doctor or dentist may tell you to temporarily stop treatment||
1514|145|P|with this medication at least 1 week before surgery or a dental||
1514|146|P|procedure. Ask your doctor or dentist for specific instructions||
1514|147|P|about when to stop and when to restart treatment with this||
1514|148|P|medication. Tell your doctor/dentist right away if you have||
1514|149|P|wounds that are not healing well.||
1514|150|P|   Tell your health care professional that you are using||
1514|151|P|ponatinib before having any immunizations/vaccinations. Avoid||
1514|152|P|contact with people who have recently received live vaccines||
1514|153|P|(such as flu vaccine inhaled through the nose).||
1514|154|P|   To lower the chance of getting cut, bruised, or injured, use||
1514|155|P|caution with sharp objects like razors and nail cutters, and||
1514|156|P|avoid activities such as contact sports.||
1514|157|P|   Older adults may be more sensitive to the side effects of this||
1514|158|P|drug, especially unusual bleeding/bruising, blood clots, swollen||
1514|159|P|legs/ankles, muscle spasms, weakness, loss of appetite.||
1514|160|P|   Tell your doctor if you are pregnant or plan to become||
1514|161|P|pregnant. You should not become pregnant while taking ponatinib.||
1514|162|P|Ponatinib may harm an unborn baby. Your doctor should order a||
1514|163|P|pregnancy test before you start this medication. Ask about||
1514|164|P|reliable forms of birth control while taking this medication and||
1514|165|P|for 3 weeks after the last dose. If you become pregnant, talk to||
1514|166|P|your doctor right away about the risks and benefits of this||
1514|167|P|medication.||
1514|168|P|   It is unknown if this medication passes into breast milk.||
1514|169|P|Because of the possible risk to the infant, breastfeeding is not||
1514|170|P|recommended while using this medication and for 1 week after the||
1514|171|P|last dose. Consult your doctor before breastfeeding.||
1514|172|B|||
1514|173|I|DRUG INTERACTIONS:  See also How to Use section.||
1514|174|I|   Drug interactions may change how your medications work or||
1514|175|I|increase your risk for serious side effects. This document does||
1514|176|I|not contain all possible drug interactions. Keep a list of all||
1514|177|I|the products you use (including prescription/nonprescription||
1514|178|I|drugs and herbal products) and share it with your doctor and||
1514|179|I|pharmacist. Do not start, stop, or change the dosage of any||
1514|180|I|medicines without your doctor's approval.||
1514|181|I|   Other medications can affect the removal of ponatinib from||
1514|182|I|your body, which may affect how ponatinib works. Examples include||
1514|183|I|azole antifungals (such as itraconazole), macrolide antibiotics||
1514|184|I|(such as erythromycin), HIV protease inhibitors (such as||
1514|185|I|lopinavir), rifamycins (such as rifabutin), ritonavir, drugs for||
1514|186|I|seizures (such as phenytoin), St. John's wort, among others.||
1514|187|B|||
1514|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1514|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1514|190|O|poison control center right away. US residents can call||
1514|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1514|192|B|||
1514|193|N|NOTES:  Do not share this medication with others.||
1514|194|N|   Lab and/or medical tests (such as blood pressure, eye exam,||
1514|195|N|liver function, complete blood counts, lipase, uric acid) should||
1514|196|N|be done while you are taking this medication. Keep all medical||
1514|197|N|and lab appointments. Consult your doctor for more details.||
1514|198|B|||
1514|199|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1514|200|D|next dose at the regular time the next day. Do not double the||
1514|201|D|dose to catch up.||
1514|202|B|||
1514|203|R|STORAGE:  Store at room temperature away from light and moisture.||
1514|204|R|Do not store in the bathroom. Keep all medications away from||
1514|205|R|children and pets.||
1514|206|R|   Do not flush medications down the toilet or pour them into a||
1514|207|R|drain unless instructed to do so. Properly discard this product||
1514|208|R|when it is expired or no longer needed. Consult your pharmacist||
1514|209|R|or local waste disposal company.||
1514|210|B|||
1514|211|M|MEDICAL ALERT:  Your condition can cause complications in a||
1514|212|M|medical emergency. For information about enrolling in MedicAlert,||
1514|213|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1514|214|B|||
1514|215|A|Information last revised September 2025.||
1514|216|A|Copyright(c) 2025 First Databank, Inc.||
1514|217|B|||
1515|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1515|002|Z|does NOT have all possible information about this product. This||
1515|003|Z|information does not assure that this product is safe, effective,||
1515|004|Z|or appropriate for you. This information is not individual||
1515|005|Z|medical advice and does not substitute for the advice of your||
1515|006|Z|health care professional. Always ask your health care||
1515|007|Z|professional for complete information about this product and your||
1515|008|Z|specific health needs.||
1515|009|B|||
1515|010|T|OXCARBAZEPINE EXTENDED-RELEASE - ORAL||
1515|011|F|(OX-kar-BAZ-e-peen)||
1515|012|B|||
1515|013|C|COMMON BRAND NAME(S): Oxtellar||
1515|014|B|||
1515|015|U|USES:  Oxcarbazepine is used with other medications to treat||
1515|016|U|seizure disorders (epilepsy).||
1515|017|B|||
1515|018|V|OTHER USES:  This section contains uses of this drug that are not||
1515|019|V|listed in the approved professional labeling for the drug but||
1515|020|V|that may be prescribed by your health care professional. Use this||
1515|021|V|drug for a condition that is listed in this section only if it||
1515|022|V|has been so prescribed by your health care professional.||
1515|023|V|   This drug may also be used for certain types of nerve pain||
1515|024|V|(such as trigeminal neuralgia).||
1515|025|B|||
1515|026|H|HOW TO USE:  Read the Medication Guide provided by your||
1515|027|H|pharmacist before you start using oxcarbazepine and each time you||
1515|028|H|get a refill. If you have any questions, consult your doctor or||
1515|029|H|pharmacist.||
1515|030|H|   Take this medication by mouth on an empty stomach (at least 1||
1515|031|H|hour before or 2 hours after food) as directed by your doctor,||
1515|032|H|usually once daily. Swallow whole. Do not crush or chew||
1515|033|H|extended-release tablets. Doing so can release all of the drug at||
1515|034|H|once, increasing the risk of side effects.||
1515|035|H|   The dosage is based on your medical condition, response to||
1515|036|H|treatment, and other medications you may be taking. Children's||
1515|037|H|dosage is also based on weight. To reduce your risk of side||
1515|038|H|effects, your doctor may direct you to start this medication at a||
1515|039|H|low dose and gradually increase your dose. Follow your doctor's||
1515|040|H|instructions carefully. Be sure to tell your doctor and||
1515|041|H|pharmacist about all the products you use (including prescription||
1515|042|H|drugs, nonprescription drugs, and herbal products).||
1515|043|H|   Use this medication regularly to get the most benefit from it.||
1515|044|H|To help you remember, take it at the same time each day.||
1515|045|H|   Do not stop taking this medication without consulting your||
1515|046|H|doctor. Some conditions (such as seizures) may become worse when||
1515|047|H|this drug is suddenly stopped. Your dose may need to be gradually||
1515|048|H|decreased.||
1515|049|H|   Tell your doctor if seizures get worse.||
1515|050|B|||
1515|051|S|SIDE EFFECTS:  Dizziness, drowsiness, tiredness, nausea,||
1515|052|S|vomiting, or headache may occur. If any of these effects last or||
1515|053|S|get worse, tell your doctor or pharmacist promptly.||
1515|054|S|   Remember that this medication has been prescribed because your||
1515|055|S|doctor has judged that the benefit to you is greater than the||
1515|056|S|risk of side effects. Many people using this medication do not||
1515|057|S|have serious side effects.||
1515|058|S|   A small number of people who take anticonvulsants for any||
1515|059|S|condition (such as seizure, bipolar disorder, pain) may||
1515|060|S|experience depression, suicidal thoughts/attempts, or other||
1515|061|S|mental/mood problems. Tell your doctor right away if you or your||
1515|062|S|family/caregiver notice any unusual/sudden changes in your mood,||
1515|063|S|thoughts, or behavior including signs of depression, suicidal||
1515|064|S|thoughts/attempts, thoughts about harming yourself.||
1515|065|S|   Tell your doctor right away if you have any serious side||
1515|066|S|effects, including: loss of coordination, vision changes (such as||
1515|067|S|double vision), rapid/uncontrollable eye movements, shaking||
1515|068|S|(tremor), easy bleeding/bruising, unusual tiredness.||
1515|069|S|   Get medical help right away if you have any very serious side||
1515|070|S|effects, including: signs of infection (such as sore throat that||
1515|071|S|doesn't go away, fever, chills, swollen lymph nodes), symptoms of||
1515|072|S|low sodium level (severe nausea, extreme drowsiness, confusion,||
1515|073|S|seizures).||
1515|074|S|   Oxcarbazepine may rarely cause very serious (possibly fatal)||
1515|075|S|skin reactions. Some people in certain ethnic groups (including||
1515|076|S|people of Asian/South Asian descent) are at greater risk. Your||
1515|077|S|doctor may order a blood test to measure your risk before||
1515|078|S|prescribing this medication. If the blood test shows you are at||
1515|079|S|greater risk, discuss the risks and benefits of oxcarbazepine and||
1515|080|S|other treatment choices with your doctor. Such skin reactions||
1515|081|S|have developed mostly within the first few months of treatment.||
1515|082|S|Get medical help right away if you develop any of the following||
1515|083|S|symptoms: skin rash/blisters/peeling, itching, or swelling. Ask||
1515|084|S|your doctor or pharmacist for more details.||
1515|085|S|   A very serious allergic reaction to this drug is rare.||
1515|086|S|However, get medical help right away if you notice any symptoms||
1515|087|S|of a serious allergic reaction, including: rash, itching/swelling||
1515|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1515|089|S|breathing.||
1515|090|S|   This is not a complete list of possible side effects. If you||
1515|091|S|notice other effects not listed above, contact your doctor or||
1515|092|S|pharmacist.||
1515|093|S|   In the US -||
1515|094|S|   Call your doctor for medical advice about side effects. You||
1515|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1515|096|S|www.fda.gov/medwatch.||
1515|097|S|   In Canada - Call your doctor for medical advice about side||
1515|098|S|effects. You may report side effects to Health Canada at||
1515|099|S|1-866-234-2345.||
1515|100|B|||
1515|101|P|PRECAUTIONS:  Before taking oxcarbazepine, tell your doctor or||
1515|102|P|pharmacist if you are allergic to it; or to carbamazepine; or to||
1515|103|P|eslicarbazepine; or to other anti-seizure medications (such as||
1515|104|P|fosphenytoin, phenobarbital, phenytoin, primidone); or if you||
1515|105|P|have any other allergies. This product may contain inactive||
1515|106|P|ingredients, which can cause allergic reactions or other||
1515|107|P|problems. Talk to your pharmacist for more details.||
1515|108|P|   Before using this medication, tell your doctor or pharmacist||
1515|109|P|your medical history, especially of: kidney disease, mineral||
1515|110|P|imbalance (low level of sodium in the blood).||
1515|111|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1515|112|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1515|113|P|machinery, or do anything that needs alertness until you can do||
1515|114|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1515|115|P|are using marijuana (cannabis).||
1515|116|P|   Before having surgery, tell your doctor or dentist about all||
1515|117|P|the products you use (including prescription drugs,||
1515|118|P|nonprescription drugs, and herbal products).||
1515|119|P|   During pregnancy, this medication should be used only when||
1515|120|P|clearly needed. It may harm an unborn baby. However, since||
1515|121|P|untreated seizures are a serious condition that can harm both a||
1515|122|P|pregnant woman and her unborn baby, do not stop taking this||
1515|123|P|medication unless directed by your doctor. If you are planning||
1515|124|P|pregnancy, become pregnant, or think you may be pregnant,||
1515|125|P|immediately discuss with your doctor the benefits and risks of||
1515|126|P|using this medication during pregnancy. Since birth control||
1515|127|P|pills, patches, implants, and injections may not work if taken||
1515|128|P|with this medication (see also Drug Interactions section),||
1515|129|P|discuss reliable forms of birth control with your doctor.||
1515|130|P|   This medication passes into breast milk but is unlikely to||
1515|131|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1515|132|B|||
1515|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1515|134|I|medications work or increase your risk for serious side effects.||
1515|135|I|This document does not contain all possible drug interactions.||
1515|136|I|Keep a list of all the products you use (including||
1515|137|I|prescription/nonprescription drugs and herbal products) and share||
1515|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
1515|139|I|the dosage of any medicines without your doctor's approval.||
1515|140|I|   A product that may interact with this drug is: orlistat.||
1515|141|I|   This medication can speed up or slow down the removal of other||
1515|142|I|medications from your body, which may affect how they work.||
1515|143|I|Examples of affected drugs include cabotegravir, cobicistat,||
1515|144|I|elvitegravir, sofosbuvir, rilpivirine, among others.||
1515|145|I|   This medication may decrease the effectiveness of hormonal||
1515|146|I|birth control such as pills, patch, or ring. This could cause||
1515|147|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1515|148|I|use reliable backup birth control methods while using this||
1515|149|I|medication. Also tell your doctor if you have any new spotting or||
1515|150|I|breakthrough bleeding, because these may be signs that your birth||
1515|151|I|control is not working well.||
1515|152|I|   Tell your doctor or pharmacist if you are taking other||
1515|153|I|products that cause drowsiness including alcohol, marijuana||
1515|154|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1515|155|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1515|156|I|zolpidem), muscle relaxants (such as carisoprodol,||
1515|157|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
1515|158|I|hydrocodone).||
1515|159|I|   Check the labels on all your medicines (such as allergy or||
1515|160|I|cough-and-cold products) because they may contain ingredients||
1515|161|I|that cause drowsiness. Ask your pharmacist about using those||
1515|162|I|products safely.||
1515|163|I|   Oxcarbazepine is very similar to eslicarbazepine. Do not use||
1515|164|I|medications containing eslicarbazepine while using oxcarbazepine.||
1515|165|B|||
1515|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1515|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1515|168|O|poison control center right away. US residents can call||
1515|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1515|170|B|||
1515|171|N|NOTES:  Do not share this medication with others.||
1515|172|N|   Lab and/or medical tests (such as sodium levels, complete||
1515|173|N|blood count) should be done while you are taking this medication.||
1515|174|N|Keep all medical and lab appointments. Consult your doctor for||
1515|175|N|more details.||
1515|176|B|||
1515|177|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1515|178|D|If it is near the time of the next dose, skip the missed dose.||
1515|179|D|Use your next dose at the regular time. Do not double the dose to||
1515|180|D|catch up.||
1515|181|B|||
1515|182|R|STORAGE:  Store at room temperature away from light and moisture.||
1515|183|R|Do not store in the bathroom. Keep all medications away from||
1515|184|R|children and pets.||
1515|185|R|   Do not flush medications down the toilet or pour them into a||
1515|186|R|drain unless instructed to do so. Properly discard this product||
1515|187|R|when it is expired or no longer needed. Consult your pharmacist||
1515|188|R|or local waste disposal company.||
1515|189|B|||
1515|190|M|MEDICAL ALERT:  Your condition can cause complications in a||
1515|191|M|medical emergency. For information about enrolling in MedicAlert,||
1515|192|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1515|193|B|||
1515|194|A|Information last revised April 2025.||
1515|195|A|Copyright(c) 2025 First Databank, Inc.||
1515|196|B|||
1516|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1516|002|Z|does NOT have all possible information about this product. This||
1516|003|Z|information does not assure that this product is safe, effective,||
1516|004|Z|or appropriate for you. This information is not individual||
1516|005|Z|medical advice and does not substitute for the advice of your||
1516|006|Z|health care professional. Always ask your health care||
1516|007|Z|professional for complete information about this product and your||
1516|008|Z|specific health needs.||
1516|009|B|||
1516|010|T|METHYLPHENIDATE EXTENDED-RELEASE SUSPENSION - ORAL||
1516|011|F|(METH-il-FEN-i-date)||
1516|012|B|||
1516|013|C|COMMON BRAND NAME(S): Quillivant XR||
1516|014|B|||
1516|015|W|WARNING:  Misuse or abuse of methylphenidate can cause serious||
1516|016|W|(possibly fatal) heart and blood pressure problems.||
1516|017|W|   This medication can be habit-forming and should be used||
1516|018|W|cautiously by people who have mental/mood disorders or a||
1516|019|W|substance use disorder (such as overuse of or addiction to||
1516|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
1516|021|W|you have a personal or family history of a substance use||
1516|022|W|disorder. Do not increase your dose, use it more often, or use it||
1516|023|W|for a longer time or in a different way than prescribed. Doing so||
1516|024|W|may result in a decrease in the effect of this drug, drug||
1516|025|W|dependence, or abnormal thoughts/behavior.||
1516|026|W|   Your doctor may monitor you for a while after the medication||
1516|027|W|is stopped, especially if you have taken this drug for a long||
1516|028|W|time or in high doses. (See also How to Use section.)||
1516|029|B|||
1516|030|U|USES:  This medication is used to treat attention deficit||
1516|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
1516|032|U|of certain natural substances in the brain. Methylphenidate||
1516|033|U|belongs to a class of drugs known as stimulants. It can help||
1516|034|U|increase your ability to pay attention, stay focused on an||
1516|035|U|activity, and control behavior problems. It may also help you to||
1516|036|U|organize your tasks and improve listening skills.||
1516|037|U|   This medication is also used to treat a certain sleep disorder||
1516|038|U|(narcolepsy).||
1516|039|B|||
1516|040|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1516|041|H|provided by your pharmacist before you start taking||
1516|042|H|methylphenidate and each time you get a refill. If you have any||
1516|043|H|questions, ask your doctor or pharmacist.||
1516|044|H|   Take this medication by mouth with or without food as directed||
1516|045|H|by your doctor, usually once daily in the morning. If you have||
1516|046|H|stomach upset, you may take this medication with or after a meal||
1516|047|H|or snack. Taking this medication late in the day may cause||
1516|048|H|trouble sleeping (insomnia).||
1516|049|H|   Before each dose, shake the bottle well for at least 10||
1516|050|H|seconds. With the bottle adapter in place, use the special||
1516|051|H|measuring device provided to carefully measure the dose. Do not||
1516|052|H|use a household spoon because you may not get the correct dose.||
1516|053|H|   The dosage is based on your medical condition and response to||
1516|054|H|treatment. Your doctor may direct you to gradually increase or||
1516|055|H|decrease your dose. Also, if you have used it for a long time, do||
1516|056|H|not suddenly stop using this drug without consulting your doctor.||
1516|057|H|   Take this medication regularly to get the most benefit from||
1516|058|H|it. To help you remember, take it at the same time each day.||
1516|059|H|   If you suddenly stop using this medication, you may have||
1516|060|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
1516|061|H|other mental/mood changes). To help prevent withdrawal, your||
1516|062|H|doctor may lower your dose slowly. Withdrawal is more likely if||
1516|063|H|you have used methylphenidate for a long time or in high doses.||
1516|064|H|Tell your doctor or pharmacist right away if you have withdrawal.||
1516|065|H|   When this medication is used for a long time, it may not work||
1516|066|H|as well. Talk with your doctor if this medication stops working||
1516|067|H|well.||
1516|068|H|   Though it helps many people, this medication may sometimes||
1516|069|H|cause addiction. This risk may be higher if you have a substance||
1516|070|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1516|071|H|Take this medication exactly as prescribed to lower the risk of||
1516|072|H|addiction. Ask your doctor or pharmacist for more details.||
1516|073|H|   Tell your doctor if your condition does not get better or if||
1516|074|H|it gets worse.||
1516|075|B|||
1516|076|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
1516|077|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
1516|078|S|If any of these effects last or get worse, tell your doctor or||
1516|079|S|pharmacist promptly.||
1516|080|S|   Remember that this medication has been prescribed because your||
1516|081|S|doctor has judged that the benefit to you is greater than the||
1516|082|S|risk of side effects. Many people using this medication do not||
1516|083|S|have serious side effects.||
1516|084|S|   This medication may raise your blood pressure. Check your||
1516|085|S|blood pressure regularly and tell your doctor if the results are||
1516|086|S|high.||
1516|087|S|   Tell your doctor right away if you have any serious side||
1516|088|S|effects, including: signs of blood flow problems in the fingers||
1516|089|S|or toes (such as coldness, numbness, pain, or skin color||
1516|090|S|changes), unusual wounds on the fingers or toes,||
1516|091|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
1516|092|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
1516|093|S|thoughts of suicide), uncontrolled muscle movements (such as||
1516|094|S|twitching, shaking), sudden outbursts of words/sounds that are||
1516|095|S|hard to control, vision changes (such as blurred vision).||
1516|096|S|   Get medical help right away if you have any very serious side||
1516|097|S|effects, including: fainting, seizure, symptoms of a heart attack||
1516|098|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
1516|099|S|sweating), symptoms of a stroke (such as weakness on one side of||
1516|100|S|the body, trouble speaking, sudden vision changes, confusion).||
1516|101|S|   Rarely, males (including young boys and teens) may have a||
1516|102|S|painful or prolonged erection lasting 4 or more hours while using||
1516|103|S|this medication. Caregivers/parents should also be watchful for||
1516|104|S|this serious side effect in boys. If a painful or prolonged||
1516|105|S|erection occurs, stop using this drug and get medical help right||
1516|106|S|away, or permanent problems could occur. Ask your doctor or||
1516|107|S|pharmacist for more details.||
1516|108|S|   A very serious allergic reaction to this drug is rare.||
1516|109|S|However, get medical help right away if you notice any symptoms||
1516|110|S|of a serious allergic reaction, including: rash, itching/swelling||
1516|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1516|112|S|breathing.||
1516|113|S|   This is not a complete list of possible side effects. If you||
1516|114|S|notice other effects not listed above, contact your doctor or||
1516|115|S|pharmacist.||
1516|116|S|   In the US -||
1516|117|S|   Call your doctor for medical advice about side effects. You||
1516|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1516|119|S|www.fda.gov/medwatch.||
1516|120|S|   In Canada - Call your doctor for medical advice about side||
1516|121|S|effects. You may report side effects to Health Canada at||
1516|122|S|1-866-234-2345.||
1516|123|B|||
1516|124|P|PRECAUTIONS:  See also Warning section.||
1516|125|P|   Before taking methylphenidate, tell your doctor or pharmacist||
1516|126|P|if you are allergic to it; or to dexmethylphenidate; or if you||
1516|127|P|have any other allergies. This product may contain inactive||
1516|128|P|ingredients, which can cause allergic reactions or other||
1516|129|P|problems. Talk to your pharmacist for more details.||
1516|130|P|   Before using this medication, tell your doctor or pharmacist||
1516|131|P|your medical history, especially of: high blood pressure, blood||
1516|132|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
1516|133|P|problems (such as irregular heartbeat, heart failure, previous||
1516|134|P|heart attack, problems with heart structure), family history of||
1516|135|P|heart problems (such as sudden cardiac death, irregular||
1516|136|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
1516|137|P|agitation), personal/family history of mental/mood disorders||
1516|138|P|(such as bipolar disorder, depression, psychosis, suicidal||
1516|139|P|thoughts), personal/family history of uncontrolled muscle||
1516|140|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
1516|141|P|(hyperthyroidism), seizure disorder.||
1516|142|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1516|143|P|can make you more dizzy. Do not drive, use machinery, or do||
1516|144|P|anything that needs alertness until you can do it safely. Limit||
1516|145|P|alcoholic beverages. Talk to your doctor if you are using||
1516|146|P|marijuana (cannabis).||
1516|147|P|   Before having surgery, tell your doctor or dentist about all||
1516|148|P|the products you use (including prescription drugs,||
1516|149|P|nonprescription drugs, and herbal products).||
1516|150|P|   Children (especially those younger than 6) may be more||
1516|151|P|sensitive to the side effects of this drug, especially weight||
1516|152|P|loss. If used for a long time, this drug may affect a child's||
1516|153|P|growth rate, weight, and final adult height. To reduce the risk,||
1516|154|P|the doctor may recommend briefly stopping the medication from||
1516|155|P|time to time. Check the child's weight and height regularly, and||
1516|156|P|consult your doctor or pharmacist for more details.||
1516|157|P|   Older adults may be more sensitive to the side effects of this||
1516|158|P|drug, especially trouble sleeping, weight loss, or chest pain.||
1516|159|P|   During pregnancy, methylphenidate should be used only when||
1516|160|P|clearly needed. Discuss the risks and benefits with your doctor.||
1516|161|P|   This medication passes into breast milk. Consult your doctor||
1516|162|P|before breastfeeding.||
1516|163|B|||
1516|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1516|165|I|medications work or increase your risk for serious side effects.||
1516|166|I|This document does not contain all possible drug interactions.||
1516|167|I|Keep a list of all the products you use (including||
1516|168|I|prescription/nonprescription drugs and herbal products) and share||
1516|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
1516|170|I|the dosage of any medicines without your doctor's approval.||
1516|171|I|   Taking MAO inhibitors with this medication may cause a serious||
1516|172|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1516|173|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1516|174|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1516|175|I|selegiline, tranylcypromine) during treatment with this||
1516|176|I|medication. Most MAO inhibitors should also not be taken for two||
1516|177|I|weeks before treatment with this medication. Ask your doctor when||
1516|178|I|to start or stop taking this medication.||
1516|179|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
1516|180|I|use medications containing dexmethylphenidate while using||
1516|181|I|methylphenidate.||
1516|182|I|   This medication may interfere with certain medical/lab tests||
1516|183|I|(such as brain scan for Parkinson's disease), possibly causing||
1516|184|I|false test results. Make sure lab personnel and all your doctors||
1516|185|I|know you use this drug.||
1516|186|B|||
1516|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1516|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1516|189|O|poison control center right away. US residents can call||
1516|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1516|191|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
1516|192|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
1516|193|O|loss of consciousness.||
1516|194|B|||
1516|195|N|NOTES:  Do not share this medication with others. Sharing it is||
1516|196|N|against the law.||
1516|197|N|   Lab and/or medical tests (such as blood pressure, complete||
1516|198|N|blood count, height/weight monitoring in children) may be done||
1516|199|N|while you are taking this medication. Keep all medical and lab||
1516|200|N|appointments. Consult your doctor for more details.||
1516|201|N|   There are different brands and forms of this medication||
1516|202|N|available. Not all have the same effects. Do not change brands or||
1516|203|N|forms without consulting your doctor or pharmacist.||
1516|204|B|||
1516|205|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1516|206|D|remember. If it is near bedtime or near the time of the next||
1516|207|D|dose, skip the missed dose. Take your next dose at the regular||
1516|208|D|time. Do not double the dose to catch up.||
1516|209|B|||
1516|210|R|STORAGE:  Store at room temperature. Once the bottle is opened,||
1516|211|R|this medication expires after 4 months. Keep all medications away||
1516|212|R|from children and pets.||
1516|213|R|   Do not flush medications down the toilet or pour them into a||
1516|214|R|drain unless instructed to do so. Properly discard this product||
1516|215|R|when it is expired or no longer needed. Consult your pharmacist||
1516|216|R|or local waste disposal company.||
1516|217|B|||
1516|218|A|Information last revised July 2025.||
1516|219|A|Copyright(c) 2025 First Databank, Inc.||
1516|220|B|||
1517|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1517|002|Z|does NOT have all possible information about this product. This||
1517|003|Z|information does not assure that this product is safe, effective,||
1517|004|Z|or appropriate for you. This information is not individual||
1517|005|Z|medical advice and does not substitute for the advice of your||
1517|006|Z|health care professional. Always ask your health care||
1517|007|Z|professional for complete information about this product and your||
1517|008|Z|specific health needs.||
1517|009|B|||
1517|010|T|CABOZANTINIB - ORAL||
1517|011|F|(KA-boe-ZAN-ti-nib)||
1517|012|B|||
1517|013|C|COMMON BRAND NAME(S): Cabometyx, Cometriq||
1517|014|B|||
1517|015|U|USES:  This medication is used to treat various types of cancer.||
1517|016|U|Cabozantinib belongs to a class of drugs known as tyrosine kinase||
1517|017|U|inhibitors. It works by slowing or stopping the growth of cancer||
1517|018|U|cells.||
1517|019|B|||
1517|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1517|021|H|from your pharmacist before you start taking cabozantinib and||
1517|022|H|each time you get a refill. If you have any questions, ask your||
1517|023|H|doctor or pharmacist.||
1517|024|H|   Since different forms of this medication (capsules, tablets)||
1517|025|H|are used to treat different types of cancer, do not change forms||
1517|026|H|of this medication unless directed by your doctor.||
1517|027|H|   Take this medication by mouth as directed by your doctor,||
1517|028|H|usually once daily. Do not take with food. Take it on an empty||
1517|029|H|stomach. Do not eat for at least 2 hours before your dose and at||
1517|030|H|least 1 hour after taking it.||
1517|031|H|   Swallow this medication whole with a full glass of water (8||
1517|032|H|ounces/240 milliliters). Do not open/split, crush, or chew the||
1517|033|H|capsules or tablets.||
1517|034|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1517|035|H|using this medication unless your doctor or pharmacist says you||
1517|036|H|may do so safely. Grapefruit can increase the chance of side||
1517|037|H|effects with this medicine. Ask your doctor or pharmacist for||
1517|038|H|more details.||
1517|039|H|   Take this medication regularly to get the most benefit from||
1517|040|H|it. To help you remember, take it at the same time each day.||
1517|041|H|   The dosage is based on your medical condition, age, weight,||
1517|042|H|response to treatment, and other medications you may be taking.||
1517|043|H|Be sure to tell your doctor and pharmacist about all the products||
1517|044|H|you use (including prescription drugs, nonprescription drugs, and||
1517|045|H|herbal products). Do not increase your dose or use this drug more||
1517|046|H|often or for longer than prescribed. Your condition will not||
1517|047|H|improve any faster, and your risk of side effects will increase.||
1517|048|B|||
1517|049|S|SIDE EFFECTS:  Dizziness, diarrhea, nausea, vomiting, mouth||
1517|050|S|sores, constipation, stomach pain, tiredness, weakness, weight||
1517|051|S|loss, decreased appetite, taste changes, hoarseness, and||
1517|052|S|lightening of hair color may occur. If any of these effects last||
1517|053|S|or get worse, tell your doctor or pharmacist promptly.||
1517|054|S|   Temporary hair loss may occur. Normal hair growth should||
1517|055|S|return after treatment has ended.||
1517|056|S|   People using this medication may have serious side effects.||
1517|057|S|However, you have been prescribed this drug because your doctor||
1517|058|S|has judged that the benefit to you is greater than the risk of||
1517|059|S|side effects. Careful monitoring by your doctor may decrease your||
1517|060|S|risk.||
1517|061|S|   Cabozantinib may rarely cause serious, possibly fatal,||
1517|062|S|stomach/abdominal side effects such as a hole in the gut wall||
1517|063|S|(perforation) or an abnormal tunnel or connection in your body||
1517|064|S|(fistula). It can also rarely cause serious, possibly fatal,||
1517|065|S|bleeding. Do not take this medication if you have serious||
1517|066|S|bleeding. Get medical help right away if you have unusual or easy||
1517|067|S|bruising/bleeding, signs of stomach/intestinal bleeding (such as||
1517|068|S|bloody/black/tarry stools, stomach/abdominal pain, bloody vomit,||
1517|069|S|vomit that looks like coffee grounds), fever, chills,||
1517|070|S|sudden/severe back pain, severe vomiting/diarrhea, or if you are||
1517|071|S|coughing/gagging/choking when eating or drinking, or coughing up||
1517|072|S|blood.||
1517|073|S|   This medication may raise your blood pressure. Check your||
1517|074|S|blood pressure regularly and tell your doctor if the results are||
1517|075|S|high. Your doctor may control your blood pressure with||
1517|076|S|medication.||
1517|077|S|   Tell your doctor right away if you have any serious side||
1517|078|S|effects, including: redness/pain/swelling/blisters on the palms||
1517|079|S|of your hands or soles of your feet, frothy urine, swelling of||
1517|080|S|the hands/feet, cold intolerance, slow heartbeat, signs of a low||
1517|081|S|calcium blood level (such as severe muscle spasms, mental/mood||
1517|082|S|changes, seizures), symptoms of a jawbone problem (such as jaw||
1517|083|S|pain, toothache, gum sores), poor wound healing, signs of liver||
1517|084|S|problems (such as yellowing eyes/skin, dark urine), signs of||
1517|085|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
1517|086|S|unusual/sudden weight gain).||
1517|087|S|   Cabozantinib may also rarely cause a serious brain condition.||
1517|088|S|Get medical help right away if you develop headaches, seizures,||
1517|089|S|vision changes, confusion, or problems thinking.||
1517|090|S|   This medication may rarely cause serious problems from blood||
1517|091|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1517|092|S|legs). Get medical help right away if you have: chest/jaw/left||
1517|093|S|arm pain, unusual sweating, sudden/severe headaches, weakness on||
1517|094|S|one side of the body, confusion, trouble speaking, sudden vision||
1517|095|S|changes, shortness of breath/rapid breathing, sudden||
1517|096|S|dizziness/fainting, pain/swelling/warmth in the groin/calf.||
1517|097|S|   This medication may lower your ability to fight infections.||
1517|098|S|This may make you more likely to get a serious (rarely fatal)||
1517|099|S|infection or make any infection you have worse. Tell your doctor||
1517|100|S|right away if you have any signs of infection (such as sore||
1517|101|S|throat that doesn't go away, fever, chills).||
1517|102|S|   When used with the medication nivolumab, cabozantinib may||
1517|103|S|cause your adrenal glands not to work well. Tell your doctor||
1517|104|S|right away if you have any signs of your adrenal glands not||
1517|105|S|working well (such as loss of appetite, unusual tiredness, weight||
1517|106|S|loss).||
1517|107|S|   A very serious allergic reaction to this drug is rare.||
1517|108|S|However, get medical help right away if you notice any symptoms||
1517|109|S|of a serious allergic reaction, including: rash, itching/swelling||
1517|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1517|111|S|breathing.||
1517|112|S|   This is not a complete list of possible side effects. If you||
1517|113|S|notice other effects not listed above, contact your doctor or||
1517|114|S|pharmacist.||
1517|115|S|   In the US -||
1517|116|S|   Call your doctor for medical advice about side effects. You||
1517|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1517|118|S|www.fda.gov/medwatch.||
1517|119|S|   In Canada - Call your doctor for medical advice about side||
1517|120|S|effects. You may report side effects to Health Canada at||
1517|121|S|1-866-234-2345.||
1517|122|B|||
1517|123|P|PRECAUTIONS:  Before taking cabozantinib, tell your doctor or||
1517|124|P|pharmacist if you are allergic to it; or if you have any other||
1517|125|P|allergies. This product may contain inactive ingredients, which||
1517|126|P|can cause allergic reactions or other problems. Talk to your||
1517|127|P|pharmacist for more details.||
1517|128|P|   Before using this medication, tell your doctor or pharmacist||
1517|129|P|your medical history, especially of: heart disease (such as heart||
1517|130|P|failure), liver disease, recent bleeding (including coughing||
1517|131|P|up/vomiting blood, bloody/black/tarry stools), high blood||
1517|132|P|pressure, blood vessel problems (such as an aneurysm or a||
1517|133|P|tear/break in the aorta or other blood vessels), open wounds.||
1517|134|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1517|135|P|can make you more dizzy. Do not drive, use machinery, or do||
1517|136|P|anything that needs alertness until you can do it safely. Limit||
1517|137|P|alcoholic beverages. Talk to your doctor if you are using||
1517|138|P|marijuana (cannabis).||
1517|139|P|   Cabozantinib can make you more likely to get infections or may||
1517|140|P|make current infections worse. Stay away from anyone who has an||
1517|141|P|infection that may easily spread (such as chickenpox, COVID-19,||
1517|142|P|measles, flu). Talk to your doctor if you have been exposed to an||
1517|143|P|infection or for more details.||
1517|144|P|   Tell your health care professional that you are using||
1517|145|P|cabozantinib before having any immunizations/vaccinations. Avoid||
1517|146|P|contact with people who have recently received live vaccines||
1517|147|P|(such as flu vaccine inhaled through the nose).||
1517|148|P|   To lower the chance of getting cut, bruised, or injured, use||
1517|149|P|caution with sharp objects like razors and nail cutters, and||
1517|150|P|avoid activities such as contact sports.||
1517|151|P|   Pain or sores in the mouth and throat may occur. Brush your||
1517|152|P|teeth carefully/gently, avoid using mouthwash that contains||
1517|153|P|alcohol, and rinse your mouth often with cool water. It may also||
1517|154|P|be best to eat soft, moist foods.||
1517|155|P|   Some people taking cabozantinib may have serious jawbone||
1517|156|P|problems. Your doctor should check your mouth before you start||
1517|157|P|this medication. Tell your dentist that you are taking this||
1517|158|P|medication before you have any dental work done. To help prevent||
1517|159|P|jawbone problems, have regular dental exams and learn how to keep||
1517|160|P|your teeth and gums healthy. If you have jaw pain, tell your||
1517|161|P|doctor and dentist right away.||
1517|162|P|   Before having any surgery (especially dental work), tell your||
1517|163|P|doctor or dentist about all the products you use (including||
1517|164|P|prescription drugs, nonprescription drugs, and herbal products).||
1517|165|P|Your doctor or dentist may tell you to stop taking cabozantinib||
1517|166|P|at least 3 or 4 weeks before surgery. This medication may cause||
1517|167|P|wounds to heal more slowly. Follow all instructions about when to||
1517|168|P|stop or restart this medication.||
1517|169|P|   Tell your doctor if you are pregnant or plan to become||
1517|170|P|pregnant. You should not become pregnant while using||
1517|171|P|cabozantinib. Cabozantinib may harm an unborn baby. Your doctor||
1517|172|P|should order a pregnancy test before you start this medication.||
1517|173|P|Ask about reliable forms of birth control while using this||
1517|174|P|medication and for 4 months after the last dose. If you become||
1517|175|P|pregnant, talk to your doctor right away about the risks and||
1517|176|P|benefits of this medication.||
1517|177|P|   It is unknown if this drug passes into breast milk. Because of||
1517|178|P|the possible risk to the infant, breastfeeding is not recommended||
1517|179|P|while using this drug and for 4 months after the last dose.||
1517|180|P|Consult your doctor before breastfeeding.||
1517|181|B|||
1517|182|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1517|183|I|medications work or increase your risk for serious side effects.||
1517|184|I|This document does not contain all possible drug interactions.||
1517|185|I|Keep a list of all the products you use (including||
1517|186|I|prescription/nonprescription drugs and herbal products) and share||
1517|187|I|it with your doctor and pharmacist. Do not start, stop, or change||
1517|188|I|the dosage of any medicines without your doctor's approval.||
1517|189|I|   Other medications can affect the removal of cabozantinib from||
1517|190|I|your body, which may affect how cabozantinib works. One example||
1517|191|I|is St. John's wort, among others.||
1517|192|B|||
1517|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1517|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1517|195|O|poison control center right away. US residents can call||
1517|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1517|197|B|||
1517|198|N|NOTES:  Do not share this medication with others.||
1517|199|N|   Lab and/or medical tests (such as blood pressure, mouth exams,||
1517|200|N|urine protein, liver/thyroid/heart function, calcium blood||
1517|201|N|levels) should be done before you start taking this medication||
1517|202|N|and while you are taking it. Keep all medical and lab||
1517|203|N|appointments. Consult your doctor for more details.||
1517|204|B|||
1517|205|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1517|206|D|remember. If it is less than 12 hours before the next dose, skip||
1517|207|D|the missed dose. Take your next dose at the regular time. Do not||
1517|208|D|double the dose to catch up.||
1517|209|B|||
1517|210|R|STORAGE:  Store at room temperature away from light and moisture.||
1517|211|R|Do not store in the bathroom. Keep all medications away from||
1517|212|R|children and pets.||
1517|213|R|   Do not flush medications down the toilet or pour them into a||
1517|214|R|drain unless instructed to do so. Properly discard this product||
1517|215|R|when it is expired or no longer needed. Consult your pharmacist||
1517|216|R|or local waste disposal company.||
1517|217|B|||
1517|218|A|Information last revised October 2025.||
1517|219|A|Copyright(c) 2025 First Databank, Inc.||
1517|220|B|||
1518|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1518|002|Z|does NOT have all possible information about this product. This||
1518|003|Z|information does not assure that this product is safe, effective,||
1518|004|Z|or appropriate for you. This information is not individual||
1518|005|Z|medical advice and does not substitute for the advice of your||
1518|006|Z|health care professional. Always ask your health care||
1518|007|Z|professional for complete information about this product and your||
1518|008|Z|specific health needs.||
1518|009|B|||
1518|010|T|LEVONORGESTREL-RELEASING 3 YEAR SYSTEM - INTRAUTERINE||
1518|011|F|(LEE-voe-nor-JES-trel)||
1518|012|B|||
1518|013|C|COMMON BRAND NAME(S): Skyla||
1518|014|B|||
1518|015|U|USES:  This product is a small, flexible device that is placed in||
1518|016|U|the womb (uterus) to prevent pregnancy. It is used by women who||
1518|017|U|want to use a reversible birth control method that works for a||
1518|018|U|long time (up to 3 years). The device slowly releases a hormone||
1518|019|U|(levonorgestrel) that is similar to a hormone that women normally||
1518|020|U|make. This device helps prevent pregnancy.||
1518|021|U|   This product does not protect against sexually transmitted||
1518|022|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1518|023|U|an effective barrier method (latex or polyurethane condom/dental||
1518|024|U|dams) during sexual activity will help to decrease your risk of||
1518|025|U|infection.||
1518|026|B|||
1518|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1518|028|H|from your pharmacist before you start using this product. If you||
1518|029|H|have any questions, ask your doctor or pharmacist.||
1518|030|H|   This device is placed in your uterus by a health care provider||
1518|031|H|during an in-office visit. It is left in place for up to 3 years.||
1518|032|H|Schedule a follow-up visit 4 to 6 weeks after the device is||
1518|033|H|placed to make sure it is still in the proper position.||
1518|034|H|   Ask your doctor if you need to use a backup form of birth||
1518|035|H|control for the first 7 days after this device is placed to||
1518|036|H|prevent pregnancy until the device has enough time to work.||
1518|037|H|   This device may sometimes move out of place or come out by||
1518|038|H|itself. After each menstrual period, check to make sure it is in||
1518|039|H|the proper position. Learn how to carefully check the position of||
1518|040|H|this device from the Patient Information Leaflet and/or your||
1518|041|H|health care provider. If it comes out or if you cannot feel the||
1518|042|H|threads, contact your doctor promptly and use a backup form of||
1518|043|H|non-hormonal birth control (such as condoms, spermicide) to||
1518|044|H|prevent pregnancy until otherwise directed by your doctor.||
1518|045|H|   If you wish to continue this method of birth control after 3||
1518|046|H|years, the used device may be removed and replaced with a new||
1518|047|H|one. Either way, the used device should be removed after 3 years.||
1518|048|H|Your health care provider can remove this device whenever you||
1518|049|H|want to stop using this method of birth control.||
1518|050|B|||
1518|051|S|SIDE EFFECTS:  Pain, bleeding, or dizziness during and after||
1518|052|S|placement of the device may occur. Cramps, irregular menstrual||
1518|053|S|periods, and vaginal bleeding between periods (spotting) may||
1518|054|S|occur, especially during the first few weeks of use. Headache,||
1518|055|S|nausea, breast tenderness, acne, or weight gain may also occur.||
1518|056|S|If any of these effects last or get worse, tell your doctor||
1518|057|S|promptly.||
1518|058|S|   After your body adjusts to this product, it is normal to have||
1518|059|S|fewer bleeding days during your menstrual periods, and some women||
1518|060|S|stop having periods altogether. This will not affect your ability||
1518|061|S|to become pregnant after stopping use of this product.||
1518|062|S|   Remember that this medication device has been prescribed||
1518|063|S|because your doctor has judged that the benefit to you is greater||
1518|064|S|than the risk of side effects. Many people using this device do||
1518|065|S|not have serious side effects.||
1518|066|S|   Tell your doctor right away if you have any serious side||
1518|067|S|effects, including: stomach/abdominal pain, vomiting, lumps in||
1518|068|S|the breast, mental/mood changes (such as new/worsening||
1518|069|S|depression), unusual changes in vaginal bleeding (such as||
1518|070|S|continuous spotting, sudden heavy bleeding, missed periods), dark||
1518|071|S|urine, yellowing eyes/skin, unusual headaches (including||
1518|072|S|headaches with vision changes/lack of coordination, worsening of||
1518|073|S|migraines, sudden/very severe headaches).||
1518|074|S|   Using an intrauterine device (IUD) may increase your risk for||
1518|075|S|a rare but serious pelvic infection (pelvic inflammatory||
1518|076|S|disease-PID), which can cause permanent damage to sex organs and||
1518|077|S|infertility. The risk is greater in women who have multiple||
1518|078|S|sexual partners, or infection with a sexually transmitted disease||
1518|079|S|(STD), or who have had PID in the past (see also Precautions||
1518|080|S|section). Tell your doctor right away if you experience symptoms||
1518|081|S|of PID, including: unexplained fever/chills, lower||
1518|082|S|abdominal/pelvic pain, pain during sexual intercourse, genital||
1518|083|S|sores, unusual vaginal discharge.||
1518|084|S|   A very serious allergic reaction to this drug is rare.||
1518|085|S|However, get medical help right away if you notice any symptoms||
1518|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1518|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1518|088|S|breathing.||
1518|089|S|   This is not a complete list of possible side effects. If you||
1518|090|S|notice other effects not listed above, contact your doctor or||
1518|091|S|pharmacist.||
1518|092|S|   In the US -||
1518|093|S|   Call your doctor for medical advice about side effects. You||
1518|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1518|095|S|www.fda.gov/medwatch.||
1518|096|S|   In Canada - Call your doctor for medical advice about side||
1518|097|S|effects. You may report side effects to Health Canada at||
1518|098|S|1-866-234-2345.||
1518|099|B|||
1518|100|P|PRECAUTIONS:  Before using this medication device, tell your||
1518|101|P|doctor or pharmacist if you are allergic to levonorgestrel, or to||
1518|102|P|any other progestins (such as norethindrone, desogestrel); or if||
1518|103|P|you have any other allergies. This product may contain inactive||
1518|104|P|ingredients, which can cause allergic reactions or other||
1518|105|P|problems. Talk to your pharmacist for more details.||
1518|106|P|   Before using this product, tell your doctor or pharmacist your||
1518|107|P|medical history, especially of: recent pregnancy, current||
1518|108|P|breastfeeding, bleeding/blood disorders, high blood pressure,||
1518|109|P|abnormal breast exam, cancer (especially endometrial, cervical,||
1518|110|P|or breast cancer), depression, diabetes, severe||
1518|111|P|headaches/migraines, heart problems (such as heart valve disease,||
1518|112|P|irregular heartbeat, previous heart attack), liver disease||
1518|113|P|(including tumors), previous pregnancy outside the uterus||
1518|114|P|(ectopic pregnancy), stroke, unexplained vaginal bleeding, uterus||
1518|115|P|problems (such as fibroids, pelvic inflammatory disease-PID),||
1518|116|P|conditions that weaken the immune system/increase the risk of||
1518|117|P|infection (such as HIV, leukemia, IV drug abuse).||
1518|118|P|   If you or partner have other sexual partners, this device may||
1518|119|P|not be the best birth control method for you. If you or your||
1518|120|P|partner get a sexually transmitted disease (including HIV,||
1518|121|P|gonorrhea, chlamydia), contact your doctor right away. Ask your||
1518|122|P|doctor if you should continue to use this device for birth||
1518|123|P|control.||
1518|124|P|   If you are going to have an MRI test, tell testing personnel||
1518|125|P|and all your doctors that you are using this device. Some brands||
1518|126|P|of this device may be safely scanned only under specific||
1518|127|P|conditions.||
1518|128|P|   Before having surgery, tell your doctor or dentist about all||
1518|129|P|the products you use (including prescription drugs,||
1518|130|P|nonprescription drugs, and herbal products).||
1518|131|P|   This device should not be used during pregnancy. If you become||
1518|132|P|pregnant or think you may be pregnant, tell your doctor right||
1518|133|P|away.||
1518|134|P|   Levonorgestrel passes into breast milk. Consult your doctor||
1518|135|P|before breastfeeding.||
1518|136|B|||
1518|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1518|138|I|medications work or increase your risk for serious side effects.||
1518|139|I|This document does not contain all possible drug interactions.||
1518|140|I|Keep a list of all the products you use (including||
1518|141|I|prescription/nonprescription drugs and herbal products) and share||
1518|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
1518|143|I|the dosage of any medicines without your doctor's approval.||
1518|144|B|||
1518|145|O|OVERDOSE:  This medication device may be harmful if swallowed. If||
1518|146|O|someone has swallowed it and has serious symptoms such as passing||
1518|147|O|out or trouble breathing, call 911. Otherwise, call a poison||
1518|148|O|control center right away. US residents can call 1-800-222-1222.||
1518|149|O|Canada residents can call 1-844-764-7669.||
1518|150|B|||
1518|151|N|NOTES:  You should have regular complete physical exams including||
1518|152|N|blood pressure, breast exam, pelvic exam, and screening for||
1518|153|N|cervical cancer (Pap smear). Follow your doctor's instructions||
1518|154|N|for examining your breasts, and report any lumps right away. Keep||
1518|155|N|all medical and lab appointments. Consult your doctor for more||
1518|156|N|details.||
1518|157|B|||
1518|158|D|MISSED DOSE:  Not applicable.||
1518|159|B|||
1518|160|R|STORAGE:  Before use, store at room temperature. Keep all||
1518|161|R|medications and medical devices away from children and pets.||
1518|162|R|   Do not flush medications down the toilet or pour them into a||
1518|163|R|drain unless instructed to do so. Properly discard this product||
1518|164|R|when it is expired or no longer needed. Consult your pharmacist||
1518|165|R|or local waste disposal company.||
1518|166|B|||
1518|167|A|Information last revised October 2025.||
1518|168|A|Copyright(c) 2025 First Databank, Inc.||
1518|169|B|||
1519|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1519|002|Z|does NOT have all possible information about this product. This||
1519|003|Z|information does not assure that this product is safe, effective,||
1519|004|Z|or appropriate for you. This information is not individual||
1519|005|Z|medical advice and does not substitute for the advice of your||
1519|006|Z|health care professional. Always ask your health care||
1519|007|Z|professional for complete information about this product and your||
1519|008|Z|specific health needs.||
1519|009|B|||
1519|010|T|ALOGLIPTIN - ORAL||
1519|011|F|(AL-oh-GLIP-tin)||
1519|012|B|||
1519|013|C|COMMON BRAND NAME(S): Nesina||
1519|014|B|||
1519|015|U|USES:  Alogliptin is used with a proper diet and exercise program||
1519|016|U|to control high blood sugar in people with type 2 diabetes.||
1519|017|U|Controlling high blood sugar helps prevent kidney damage,||
1519|018|U|blindness, nerve problems, loss of limbs, and sexual function||
1519|019|U|problems. Proper control of diabetes may also lessen your risk of||
1519|020|U|a heart attack or stroke.||
1519|021|U|   Alogliptin works by increasing levels of natural substances||
1519|022|U|called incretins. Incretins help to control blood sugar by||
1519|023|U|increasing insulin release, especially after a meal. They also||
1519|024|U|decrease the amount of sugar your liver makes.||
1519|025|B|||
1519|026|H|HOW TO USE:  Read the Medication Guide provided by your||
1519|027|H|pharmacist before you start using alogliptin and each time you||
1519|028|H|get a refill. If you have any questions, ask your doctor or||
1519|029|H|pharmacist.||
1519|030|H|   Take this medication by mouth as directed by your doctor,||
1519|031|H|usually once daily with or without food.||
1519|032|H|   The dosage is based on your medical condition and response to||
1519|033|H|treatment. Take this medication regularly to get the most benefit||
1519|034|H|from it. To help you remember, take it at the same time each day.||
1519|035|H|Carefully follow your diabetes management plan, including||
1519|036|H|medications, diet, and exercise.||
1519|037|H|   Check your blood sugar regularly as directed by your doctor.||
1519|038|H|Keep track of the results, and share them with your doctor. Tell||
1519|039|H|your doctor if your blood sugar measurements are often too high||
1519|040|H|or too low. Your doctor may need to adjust your diabetes||
1519|041|H|medication, exercise program, or diet.||
1519|042|B|||
1519|043|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1519|044|S|because your doctor has judged that the benefit to you is greater||
1519|045|S|than the risk of side effects. Many people using this medication||
1519|046|S|do not have serious side effects.||
1519|047|S|   Tell your doctor right away if you have any serious side||
1519|048|S|effects, including: joint pain, unusual skin blisters, signs of||
1519|049|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1519|050|S|unusual tiredness, unusual/sudden weight gain).||
1519|051|S|   Alogliptin does not usually cause low blood sugar||
1519|052|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1519|053|S|prescribed with other diabetes medications, or if you do not get||
1519|054|S|enough calories from food, or if you do unusually heavy exercise.||
1519|055|S|Talk with your doctor or pharmacist about whether the dose of||
1519|056|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1519|057|S|of low blood sugar include sudden sweating, shaking, fast||
1519|058|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1519|059|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1519|060|S|treat low blood sugar. If you don't have these reliable forms of||
1519|061|S|glucose, rapidly raise your blood sugar by eating a quick source||
1519|062|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1519|063|S|juice or non-diet soda. Tell your doctor right away about the||
1519|064|S|reaction and the use of this product. To help prevent low blood||
1519|065|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1519|066|S|Check with your doctor or pharmacist to find out what you should||
1519|067|S|do if you miss a meal.||
1519|068|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1519|069|S|thirst/urination. If these symptoms occur, tell your doctor right||
1519|070|S|away. Your doctor may need to adjust your diabetes medication,||
1519|071|S|exercise program, or diet.||
1519|072|S|   Get medical help right away if you have any very serious side||
1519|073|S|effects, including: signs of pancreatitis (such as||
1519|074|S|nausea/vomiting that doesn't stop, loss of appetite, severe||
1519|075|S|stomach/abdominal/back pain), dark urine, yellowing eyes/skin.||
1519|076|S|   A very serious allergic reaction to this drug is rare.||
1519|077|S|However, get medical help right away if you notice any symptoms||
1519|078|S|of a serious allergic reaction, including: rash, itching/swelling||
1519|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1519|080|S|breathing.||
1519|081|S|   This is not a complete list of possible side effects. If you||
1519|082|S|notice other effects not listed above, contact your doctor or||
1519|083|S|pharmacist.||
1519|084|S|   In the US -||
1519|085|S|   Call your doctor for medical advice about side effects. You||
1519|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1519|087|S|www.fda.gov/medwatch.||
1519|088|S|   In Canada - Call your doctor for medical advice about side||
1519|089|S|effects. You may report side effects to Health Canada at||
1519|090|S|1-866-234-2345.||
1519|091|B|||
1519|092|P|PRECAUTIONS:  Before taking alogliptin, tell your doctor or||
1519|093|P|pharmacist if you are allergic to it; or if you have any other||
1519|094|P|allergies. This product may contain inactive ingredients, which||
1519|095|P|can cause allergic reactions or other problems. Talk to your||
1519|096|P|pharmacist for more details.||
1519|097|P|   Before using this medication, tell your doctor or pharmacist||
1519|098|P|your medical history, especially of: kidney disease, heart||
1519|099|P|failure, liver problems, disease of the pancreas (pancreatitis),||
1519|100|P|stones in your gallbladder (gallstones).||
1519|101|P|   You may experience blurred vision, dizziness, or drowsiness||
1519|102|P|due to extremely low or high blood sugar. Do not drive, use||
1519|103|P|machinery, or do anything that needs alertness or clear vision||
1519|104|P|until you can do it safely.||
1519|105|P|   Limit alcohol while taking this medication because it can||
1519|106|P|increase your risk of developing low blood sugar.||
1519|107|P|   It may be harder to control your blood sugar when your body is||
1519|108|P|stressed (such as due to fever, infection, injury, or surgery).||
1519|109|P|Consult your doctor because this may require a change in your||
1519|110|P|treatment plan, medications, or blood sugar testing.||
1519|111|P|   Before having surgery, tell your doctor or dentist about all||
1519|112|P|the products you use (including prescription drugs,||
1519|113|P|nonprescription drugs, and herbal products).||
1519|114|P|   During pregnancy, this medication should be used only when||
1519|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
1519|116|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1519|117|P|your doctor for managing your blood sugar while pregnant. Your||
1519|118|P|doctor may change your diabetes treatment during your pregnancy||
1519|119|P|(such as diet and medications including insulin).||
1519|120|P|   It is unknown if this drug passes into breast milk. Consult||
1519|121|P|your doctor before breastfeeding.||
1519|122|B|||
1519|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1519|124|I|medications work or increase your risk for serious side effects.||
1519|125|I|This document does not contain all possible drug interactions.||
1519|126|I|Keep a list of all the products you use (including||
1519|127|I|prescription/nonprescription drugs and herbal products) and share||
1519|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
1519|129|I|the dosage of any medicines without your doctor's approval.||
1519|130|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1519|131|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1519|132|I|heartbeat you would usually feel when your blood sugar falls too||
1519|133|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1519|134|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1519|135|I|   Many drugs can affect your blood sugar, making it harder to||
1519|136|I|control. Before you start, stop, or change any medication, talk||
1519|137|I|with your doctor or pharmacist about how the medication may||
1519|138|I|affect your blood sugar. Check your blood sugar regularly as||
1519|139|I|directed and share the results with your doctor. Tell your doctor||
1519|140|I|right away if you have symptoms of high or low blood sugar. (See||
1519|141|I|also Side Effects section.) Your doctor may need to adjust your||
1519|142|I|diabetes medication, exercise program, or diet.||
1519|143|B|||
1519|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1519|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1519|146|O|poison control center right away. US residents can call||
1519|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1519|148|B|||
1519|149|N|NOTES:  Do not share this medication with others.||
1519|150|N|   Attend a diabetes education program to learn more about how to||
1519|151|N|manage your diabetes with medications, diet, exercise, and||
1519|152|N|regular medical exams.||
1519|153|N|   Learn the symptoms of high and low blood sugar and how to||
1519|154|N|treat low blood sugar. Check your blood sugar regularly as||
1519|155|N|directed.||
1519|156|N|   Lab and/or medical tests (such as kidney/liver function, blood||
1519|157|N|glucose, hemoglobin A1c) should be done before you start taking||
1519|158|N|this medication and while you are taking it. Keep all medical and||
1519|159|N|lab appointments. Consult your doctor for more details.||
1519|160|B|||
1519|161|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1519|162|D|remember. If it is near the time of the next dose, skip the||
1519|163|D|missed dose. Take your next dose at the regular time. Do not||
1519|164|D|double the dose to catch up.||
1519|165|B|||
1519|166|R|STORAGE:  Store at room temperature away from light and moisture.||
1519|167|R|Do not store in the bathroom. Keep all medications away from||
1519|168|R|children and pets.||
1519|169|R|   Do not flush medications down the toilet or pour them into a||
1519|170|R|drain unless instructed to do so. Properly discard this product||
1519|171|R|when it is expired or no longer needed. Consult your pharmacist||
1519|172|R|or local waste disposal company.||
1519|173|B|||
1519|174|M|MEDICAL ALERT:  Your condition can cause complications in a||
1519|175|M|medical emergency. For information about enrolling in MedicAlert,||
1519|176|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1519|177|B|||
1519|178|A|Information last revised November 2025.||
1519|179|A|Copyright(c) 2025 First Databank, Inc.||
1519|180|B|||
1520|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1520|002|Z|does NOT have all possible information about this product. This||
1520|003|Z|information does not assure that this product is safe, effective,||
1520|004|Z|or appropriate for you. This information is not individual||
1520|005|Z|medical advice and does not substitute for the advice of your||
1520|006|Z|health care professional. Always ask your health care||
1520|007|Z|professional for complete information about this product and your||
1520|008|Z|specific health needs.||
1520|009|B|||
1520|010|T|ALOGLIPTIN/METFORMIN - ORAL||
1520|011|F|(AL-oh-GLIP-tin/met-FOR-min)||
1520|012|B|||
1520|013|C|COMMON BRAND NAME(S): Kazano||
1520|014|B|||
1520|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1520|016|W|cause a serious (sometimes fatal) condition called lactic||
1520|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1520|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1520|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1520|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1520|021|W|you are using certain drugs. For some conditions, your doctor may||
1520|022|W|tell you to stop taking this medication for a short time. Ask||
1520|023|W|your doctor or pharmacist for more details.||
1520|024|W|   Stop taking this medication and get medical help right away if||
1520|025|W|you have any symptoms of lactic acidosis, such as unusual||
1520|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1520|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1520|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1520|029|B|||
1520|030|U|USES:  This combination medication is used with a proper diet and||
1520|031|U|exercise program to control high blood sugar in people with type||
1520|032|U|2 diabetes. Controlling high blood sugar helps prevent kidney||
1520|033|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1520|034|U|function problems. Proper control of diabetes may also lessen||
1520|035|U|your risk of a heart attack or stroke.||
1520|036|U|   This product contains 2 medications: alogliptin and metformin.||
1520|037|U|Alogliptin works by increasing levels of natural substances||
1520|038|U|called incretins. Incretins help to control blood sugar by||
1520|039|U|increasing insulin release, especially after a meal. They also||
1520|040|U|decrease the amount of sugar your liver makes. Metformin works by||
1520|041|U|helping to restore your body's proper response to the insulin you||
1520|042|U|naturally produce. It also decreases the amount of sugar that||
1520|043|U|your liver makes and that your stomach/intestines absorb.||
1520|044|B|||
1520|045|H|HOW TO USE:  Read the Medication Guide provided by your||
1520|046|H|pharmacist before you start using alogliptin/metformin and each||
1520|047|H|time you get a refill. If you have any questions, ask your doctor||
1520|048|H|or pharmacist.||
1520|049|H|   Take this medication by mouth as directed by your doctor,||
1520|050|H|usually twice a day with meals. Drink plenty of fluids while||
1520|051|H|taking this medication unless otherwise directed by your doctor.||
1520|052|H|Do not break/cut the tablet before taking it. If you have trouble||
1520|053|H|swallowing the tablet whole, tell your doctor.||
1520|054|H|   The dosage is based on your medical condition, response to||
1520|055|H|treatment, and other medications you may be taking. Be sure to||
1520|056|H|tell your doctor and pharmacist about all the products you use||
1520|057|H|(including prescription drugs, nonprescription drugs, and herbal||
1520|058|H|products). To reduce your risk of side effects (such as upset||
1520|059|H|stomach), your doctor may direct you to start this medication at||
1520|060|H|a low dose and gradually increase your dose. Take this medication||
1520|061|H|regularly to get the most benefit from it. To help you remember,||
1520|062|H|take it at the same times each day. Carefully follow your||
1520|063|H|diabetes management plan, including medications, diet, and||
1520|064|H|exercise.||
1520|065|H|   Check your blood sugar regularly as directed by your doctor.||
1520|066|H|Keep track of the results, and share them with your doctor. Tell||
1520|067|H|your doctor if your blood sugar measurements are often too high||
1520|068|H|or too low. Your doctor may need to adjust your diabetes||
1520|069|H|medication, exercise program, or diet.||
1520|070|B|||
1520|071|S|SIDE EFFECTS:  See also Warning section.||
1520|072|S|   Nausea, vomiting, stomach upset, diarrhea, bloating/gas, or||
1520|073|S|weakness may occur. If any of these effects last or get worse,||
1520|074|S|tell your doctor or pharmacist promptly. If stomach symptoms||
1520|075|S|return later (after taking the same dose for several days or||
1520|076|S|weeks), tell your doctor right away. Stomach symptoms that occur||
1520|077|S|after the first days of your treatment may be signs of lactic||
1520|078|S|acidosis.||
1520|079|S|   Remember that this medication has been prescribed because your||
1520|080|S|doctor has judged that the benefit to you is greater than the||
1520|081|S|risk of side effects. Many people using this medication do not||
1520|082|S|have serious side effects.||
1520|083|S|   Tell your doctor right away if you have any serious side||
1520|084|S|effects, including: joint pain, unusual skin blisters, signs of||
1520|085|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1520|086|S|unusual tiredness, unusual/sudden weight gain).||
1520|087|S|   Get medical help right away if you have any very serious side||
1520|088|S|effects, including: signs of pancreatitis (such as||
1520|089|S|nausea/vomiting that doesn't stop, loss of appetite, severe||
1520|090|S|stomach/abdominal/back pain), dark urine, yellowing eyes/skin.||
1520|091|S|   This medication does not usually cause low blood sugar||
1520|092|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1520|093|S|prescribed with other diabetes medications, or if you do not get||
1520|094|S|enough calories from food, or if you do unusually heavy exercise.||
1520|095|S|Talk with your doctor or pharmacist about whether the dose of||
1520|096|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1520|097|S|of low blood sugar include sudden sweating, shaking, fast||
1520|098|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1520|099|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1520|100|S|treat low blood sugar. If you don't have these reliable forms of||
1520|101|S|glucose, rapidly raise your blood sugar by eating a quick source||
1520|102|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1520|103|S|juice or non-diet soda. Tell your doctor right away about the||
1520|104|S|reaction and the use of this product. To help prevent low blood||
1520|105|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1520|106|S|Check with your doctor or pharmacist to find out what you should||
1520|107|S|do if you miss a meal.||
1520|108|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1520|109|S|thirst/urination. If these symptoms occur, tell your doctor right||
1520|110|S|away. Your doctor may need to adjust your diabetes medication,||
1520|111|S|exercise program, or diet.||
1520|112|S|   A very serious allergic reaction to this drug is rare.||
1520|113|S|However, get medical help right away if you notice any symptoms||
1520|114|S|of a serious allergic reaction, including: rash, itching/swelling||
1520|115|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1520|116|S|breathing.||
1520|117|S|   This is not a complete list of possible side effects. If you||
1520|118|S|notice other effects not listed above, contact your doctor or||
1520|119|S|pharmacist.||
1520|120|S|   In the US -||
1520|121|S|   Call your doctor for medical advice about side effects. You||
1520|122|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1520|123|S|www.fda.gov/medwatch.||
1520|124|S|   In Canada - Call your doctor for medical advice about side||
1520|125|S|effects. You may report side effects to Health Canada at||
1520|126|S|1-866-234-2345.||
1520|127|B|||
1520|128|P|PRECAUTIONS:  See also Warning section.||
1520|129|P|   Before taking this medication, tell your doctor or pharmacist||
1520|130|P|if you are allergic to alogliptin or metformin; or if you have||
1520|131|P|any other allergies. This product may contain inactive||
1520|132|P|ingredients, which can cause allergic reactions or other||
1520|133|P|problems. Talk to your pharmacist for more details.||
1520|134|P|   Before using this medication, tell your doctor or pharmacist||
1520|135|P|your medical history, especially of: breathing problems (such as||
1520|136|P|asthma, obstructive lung disease), kidney disease, liver||
1520|137|P|problems, disease of the pancreas (pancreatitis), stones in your||
1520|138|P|gallbladder (gallstones), vitamin B12 deficiency.||
1520|139|P|   You may experience blurred vision, dizziness, or drowsiness||
1520|140|P|due to extremely low or high blood sugar. Do not drive, use||
1520|141|P|machinery, or do anything that needs alertness or clear vision||
1520|142|P|until you can do it safely.||
1520|143|P|   Limit alcohol while using this medication because it can||
1520|144|P|increase your risk of lactic acidosis and developing low blood||
1520|145|P|sugar.||
1520|146|P|   Before having surgery or any X-ray/scanning procedure using||
1520|147|P|iodinated contrast, tell your doctor or dentist about all the||
1520|148|P|products you use (including prescription drugs, nonprescription||
1520|149|P|drugs, and herbal products). You may need to stop this medication||
1520|150|P|for a short time for the surgery/procedure. Ask your doctor or||
1520|151|P|dentist for instructions before your surgery/procedure.||
1520|152|P|   High fever, "water pills"/diuretics (such as||
1520|153|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1520|154|P|may cause dehydration and increase your risk of lactic acidosis.||
1520|155|P|Stop taking this medication and tell your doctor right away if||
1520|156|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1520|157|P|fluids to prevent dehydration unless your doctor directs you||
1520|158|P|otherwise.||
1520|159|P|   It may be harder to control your blood sugar when your body is||
1520|160|P|stressed (such as due to fever, infection, injury, or surgery).||
1520|161|P|Consult your doctor because this may require a change in your||
1520|162|P|treatment plan, medications, or blood sugar testing.||
1520|163|P|   Older adults may be at greater risk for side effects such as||
1520|164|P|low blood sugar or lactic acidosis.||
1520|165|P|   This medication can cause changes in a woman's menstrual cycle||
1520|166|P|(promote ovulation) and increase the chance of pregnancy. Consult||
1520|167|P|your doctor or pharmacist about using reliable birth control||
1520|168|P|while taking this medication.||
1520|169|P|   During pregnancy, this medication should be used only when||
1520|170|P|clearly needed. Discuss the risks and benefits with your doctor.||
1520|171|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1520|172|P|your doctor for managing your blood sugar while pregnant. Your||
1520|173|P|doctor may change your diabetes treatment during your pregnancy||
1520|174|P|(such as diet and medications including insulin).||
1520|175|P|   Metformin passes into breast milk in small amounts. It is||
1520|176|P|unknown if alogliptin passes into breast milk. Consult your||
1520|177|P|doctor before breastfeeding.||
1520|178|B|||
1520|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1520|180|I|medications work or increase your risk for serious side effects.||
1520|181|I|This document does not contain all possible drug interactions.||
1520|182|I|Keep a list of all the products you use (including||
1520|183|I|prescription/nonprescription drugs and herbal products) and share||
1520|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
1520|185|I|the dosage of any medicines without your doctor's approval.||
1520|186|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1520|187|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1520|188|I|heartbeat you would usually feel when your blood sugar falls too||
1520|189|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1520|190|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1520|191|I|   Many drugs can affect your blood sugar, making it harder to||
1520|192|I|control. Before you start, stop, or change any medication, talk||
1520|193|I|with your doctor or pharmacist about how the medication may||
1520|194|I|affect your blood sugar. Check your blood sugar regularly as||
1520|195|I|directed and share the results with your doctor. Tell your doctor||
1520|196|I|right away if you have symptoms of high or low blood sugar. (See||
1520|197|I|also Side Effects section.) Your doctor may need to adjust your||
1520|198|I|diabetes medication, exercise program, or diet.||
1520|199|B|||
1520|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1520|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1520|202|O|poison control center right away. US residents can call||
1520|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1520|204|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
1520|205|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
1520|206|O|rapid breathing, slow/irregular heartbeat.||
1520|207|B|||
1520|208|N|NOTES:  Do not share this medication with others.||
1520|209|N|   Attend a diabetes education program to learn more about how to||
1520|210|N|manage your diabetes with medications, diet, exercise, and||
1520|211|N|regular medical exams.||
1520|212|N|   Learn the symptoms of high and low blood sugar and how to||
1520|213|N|treat low blood sugar. Check your blood sugar regularly as||
1520|214|N|directed.||
1520|215|N|   Lab and/or medical tests (such as kidney function, liver||
1520|216|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
1520|217|N|should be done before you start taking this medication and while||
1520|218|N|you are taking it. Keep all medical and lab appointments. Consult||
1520|219|N|your doctor for more details.||
1520|220|B|||
1520|221|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1520|222|D|remember. If it is near the time of the next dose, skip the||
1520|223|D|missed dose. Take your next dose at the regular time. Do not||
1520|224|D|double the dose to catch up.||
1520|225|B|||
1520|226|R|STORAGE:  Store at room temperature away from light and moisture.||
1520|227|R|Do not store in the bathroom. Keep all medications away from||
1520|228|R|children and pets.||
1520|229|R|   Do not flush medications down the toilet or pour them into a||
1520|230|R|drain unless instructed to do so. Properly discard this product||
1520|231|R|when it is expired or no longer needed. Consult your pharmacist||
1520|232|R|or local waste disposal company.||
1520|233|B|||
1520|234|M|MEDICAL ALERT:  Your condition can cause complications in a||
1520|235|M|medical emergency. For information about enrolling in MedicAlert,||
1520|236|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1520|237|B|||
1520|238|A|Information last revised May 2025.||
1520|239|A|Copyright(c) 2025 First Databank, Inc.||
1520|240|B|||
1521|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1521|002|Z|does NOT have all possible information about this product. This||
1521|003|Z|information does not assure that this product is safe, effective,||
1521|004|Z|or appropriate for you. This information is not individual||
1521|005|Z|medical advice and does not substitute for the advice of your||
1521|006|Z|health care professional. Always ask your health care||
1521|007|Z|professional for complete information about this product and your||
1521|008|Z|specific health needs.||
1521|009|B|||
1521|010|T|ALOGLIPTIN/PIOGLITAZONE - ORAL||
1521|011|F|(AL-oh-GLIP-tin/PYE-oh-GLI-ta-zone)||
1521|012|B|||
1521|013|C|COMMON BRAND NAME(S): Oseni||
1521|014|B|||
1521|015|W|WARNING:  This combination medication may rarely cause or worsen||
1521|016|W|a certain heart problem (heart failure). Tell your doctor right||
1521|017|W|away if you notice any symptoms of heart failure, including:||
1521|018|W|shortness of breath, swelling ankles/feet, unusual tiredness,||
1521|019|W|unusual/sudden weight gain.||
1521|020|W|   This medication is not recommended for people with certain||
1521|021|W|types of heart failure. Before using this medication, tell your||
1521|022|W|doctor if you have heart failure.||
1521|023|B|||
1521|024|U|USES:  This combination medication is used with a proper diet and||
1521|025|U|exercise program to control high blood sugar in people with type||
1521|026|U|2 diabetes. Controlling high blood sugar helps prevent kidney||
1521|027|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1521|028|U|function problems. Proper control of diabetes may also lessen||
1521|029|U|your risk of a heart attack or stroke.||
1521|030|U|   This product contains 2 medications: alogliptin and||
1521|031|U|pioglitazone. Alogliptin works by increasing levels of natural||
1521|032|U|substances called incretins. Incretins help to control blood||
1521|033|U|sugar by increasing insulin release, especially after a meal.||
1521|034|U|They also decrease the amount of sugar your liver makes.||
1521|035|U|Pioglitazone works by helping to restore your body's proper||
1521|036|U|response to insulin.||
1521|037|B|||
1521|038|H|HOW TO USE:  Read the Medication Guide provided by your||
1521|039|H|pharmacist before you start using alogliptin/pioglitazone and||
1521|040|H|each time you get a refill. If you have any questions, ask your||
1521|041|H|doctor or pharmacist.||
1521|042|H|   Take this medication by mouth as directed by your doctor,||
1521|043|H|usually once daily with or without food. The manufacturer directs||
1521|044|H|not to split, break, or cut the tablet before taking it. However,||
1521|045|H|many similar drugs (immediate-release tablets) can be split,||
1521|046|H|broken, or cut. Follow your doctor's directions on how to take||
1521|047|H|this medication.||
1521|048|H|   The dosage is based on your medical condition, response to||
1521|049|H|treatment, and other medications you may be taking. Be sure to||
1521|050|H|tell your doctor and pharmacist about all the products you use||
1521|051|H|(including prescription drugs, nonprescription drugs, and herbal||
1521|052|H|products).||
1521|053|H|   Take this medication regularly to get the most benefit from||
1521|054|H|it. To help you remember, take it at the same time each day.||
1521|055|H|Carefully follow your diabetes management plan, including||
1521|056|H|medications, diet, and exercise.||
1521|057|H|   Check your blood sugar regularly as directed by your doctor.||
1521|058|H|Keep track of the results, and share them with your doctor. Tell||
1521|059|H|your doctor if your blood sugar measurements are often too high||
1521|060|H|or too low. Your doctor may need to adjust your diabetes||
1521|061|H|medication, exercise program, or diet.||
1521|062|B|||
1521|063|S|SIDE EFFECTS:  See also Warning section.||
1521|064|S|   Sore throat, muscle pain, or weight gain may occur. If any of||
1521|065|S|these effects last or get worse, tell your doctor or pharmacist||
1521|066|S|promptly.||
1521|067|S|   Remember that this medication has been prescribed because your||
1521|068|S|doctor has judged that the benefit to you is greater than the||
1521|069|S|risk of side effects. Many people using this medication do not||
1521|070|S|have serious side effects.||
1521|071|S|   Tell your doctor right away if you have any serious side||
1521|072|S|effects, including: new/worsening vision problems (such as||
1521|073|S|blurred vision), bone fracture, reddish-colored urine,||
1521|074|S|frequent/painful urination, joint pain, unusual skin blisters.||
1521|075|S|   Get medical help right away if you have any very serious side||
1521|076|S|effects, including: signs of pancreatitis (such as||
1521|077|S|nausea/vomiting that doesn't stop, loss of appetite, severe||
1521|078|S|stomach/abdominal/back pain), dark urine, yellowing eyes/skin.||
1521|079|S|   This medication does not usually cause low blood sugar||
1521|080|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1521|081|S|prescribed with other diabetes medications, or if you do not get||
1521|082|S|enough calories from food, or if you do unusually heavy exercise.||
1521|083|S|Talk with your doctor or pharmacist about whether the dose of||
1521|084|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1521|085|S|of low blood sugar include sudden sweating, shaking, fast||
1521|086|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1521|087|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1521|088|S|treat low blood sugar. If you don't have these reliable forms of||
1521|089|S|glucose, rapidly raise your blood sugar by eating a quick source||
1521|090|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1521|091|S|juice or non-diet soda. Tell your doctor right away about the||
1521|092|S|reaction and the use of this product. To help prevent low blood||
1521|093|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1521|094|S|Check with your doctor or pharmacist to find out what you should||
1521|095|S|do if you miss a meal.||
1521|096|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1521|097|S|thirst/urination. If these symptoms occur, tell your doctor right||
1521|098|S|away. Your doctor may need to adjust your diabetes medication,||
1521|099|S|exercise program, or diet.||
1521|100|S|   A very serious allergic reaction to this drug is rare.||
1521|101|S|However, get medical help right away if you notice any symptoms||
1521|102|S|of a serious allergic reaction, including: rash, itching/swelling||
1521|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1521|104|S|breathing.||
1521|105|S|   This is not a complete list of possible side effects. If you||
1521|106|S|notice other effects not listed above, contact your doctor or||
1521|107|S|pharmacist.||
1521|108|S|   In the US -||
1521|109|S|   Call your doctor for medical advice about side effects. You||
1521|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1521|111|S|www.fda.gov/medwatch.||
1521|112|S|   In Canada - Call your doctor for medical advice about side||
1521|113|S|effects. You may report side effects to Health Canada at||
1521|114|S|1-866-234-2345.||
1521|115|B|||
1521|116|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1521|117|P|pharmacist if you are allergic to alogliptin or pioglitazone; or||
1521|118|P|if you have any other allergies. This product may contain||
1521|119|P|inactive ingredients, which can cause allergic reactions or other||
1521|120|P|problems. Talk to your pharmacist for more details.||
1521|121|P|   Before using this medication, tell your doctor or pharmacist||
1521|122|P|your medical history, especially of: bladder cancer, heart||
1521|123|P|problems (such as heart failure, chest pain), kidney disease,||
1521|124|P|liver problems, fluid in your lungs, a certain eye problem||
1521|125|P|(macular edema), disease of the pancreas (pancreatitis), stones||
1521|126|P|in your gallbladder (gallstones), swelling (edema).||
1521|127|P|   You may experience blurred vision, dizziness, or drowsiness||
1521|128|P|due to extremely low or high blood sugar. Do not drive, use||
1521|129|P|machinery, or do anything that needs alertness or clear vision||
1521|130|P|until you can do it safely.||
1521|131|P|   Limit alcohol while taking this medication because it can||
1521|132|P|increase the risk of developing low blood sugar.||
1521|133|P|   It may be harder to control your blood sugar when your body is||
1521|134|P|stressed (such as due to fever, infection, injury, or surgery).||
1521|135|P|Consult your doctor because this may require a change in your||
1521|136|P|treatment plan, medications, or blood sugar testing.||
1521|137|P|   Before having surgery, tell your doctor or dentist about all||
1521|138|P|the products you use (including prescription drugs,||
1521|139|P|nonprescription drugs, and herbal products).||
1521|140|P|   This medication may increase the risk of bone fracture||
1521|141|P|(usually in the forearm, wrist, hand, or foot), especially in||
1521|142|P|women. See also Notes section.||
1521|143|P|   This medication can cause changes in a woman's menstrual cycle||
1521|144|P|(promote ovulation) and increase the chance of pregnancy. Consult||
1521|145|P|your doctor or pharmacist about using reliable birth control||
1521|146|P|while taking this medication.||
1521|147|P|   During pregnancy, this medication should be used only when||
1521|148|P|clearly needed. Discuss the risks and benefits with your doctor.||
1521|149|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1521|150|P|your doctor for managing your blood sugar while pregnant. Your||
1521|151|P|doctor may change your diabetes treatment during your pregnancy||
1521|152|P|(such as diet and medications including insulin).||
1521|153|P|   It is unknown if this drug passes into breast milk. Consult||
1521|154|P|your doctor before breastfeeding.||
1521|155|B|||
1521|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1521|157|I|medications work or increase your risk for serious side effects.||
1521|158|I|This document does not contain all possible drug interactions.||
1521|159|I|Keep a list of all the products you use (including||
1521|160|I|prescription/nonprescription drugs and herbal products) and share||
1521|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
1521|162|I|the dosage of any medicines without your doctor's approval.||
1521|163|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1521|164|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1521|165|I|heartbeat you would usually feel when your blood sugar falls too||
1521|166|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1521|167|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1521|168|I|   Many drugs can affect your blood sugar, making it harder to||
1521|169|I|control. Before you start, stop, or change any medication, talk||
1521|170|I|with your doctor or pharmacist about how the medication may||
1521|171|I|affect your blood sugar. Check your blood sugar regularly as||
1521|172|I|directed and share the results with your doctor. Tell your doctor||
1521|173|I|right away if you have symptoms of high or low blood sugar. (See||
1521|174|I|also Side Effects section.) Your doctor may need to adjust your||
1521|175|I|diabetes medication, exercise program, or diet.||
1521|176|B|||
1521|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1521|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1521|179|O|poison control center right away. US residents can call||
1521|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1521|181|B|||
1521|182|N|NOTES:  Do not share this medication with others.||
1521|183|N|   Attend a diabetes education program to learn more about how to||
1521|184|N|manage your diabetes with medications, diet, exercise, and||
1521|185|N|regular medical exams.||
1521|186|N|   Learn the symptoms of high and low blood sugar and how to||
1521|187|N|treat low blood sugar. Check your blood sugar regularly as||
1521|188|N|directed.||
1521|189|N|   Lab and/or medical tests (such as kidney/liver function, blood||
1521|190|N|glucose, hemoglobin A1c, complete blood counts, eye exams) should||
1521|191|N|be done before you start taking this medication and while you are||
1521|192|N|taking it. Keep all medical and lab appointments. Consult your||
1521|193|N|doctor for more details.||
1521|194|N|   Lifestyle changes that help promote healthy bones include||
1521|195|N|increasing weight-bearing exercise, eating well-balanced meals||
1521|196|N|containing adequate calcium and vitamin D, stopping smoking, and||
1521|197|N|limiting alcohol. Consult your doctor about calcium/vitamin D||
1521|198|N|supplements and to discuss lifestyle changes that might benefit||
1521|199|N|you.||
1521|200|B|||
1521|201|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1521|202|D|remember. If it is near the time of the next dose, skip the||
1521|203|D|missed dose. Take your next dose at the regular time. Do not||
1521|204|D|double the dose to catch up.||
1521|205|B|||
1521|206|R|STORAGE:  Store at room temperature away from light and moisture.||
1521|207|R|Do not store in the bathroom. Keep all medications away from||
1521|208|R|children and pets.||
1521|209|R|   Do not flush medications down the toilet or pour them into a||
1521|210|R|drain unless instructed to do so. Properly discard this product||
1521|211|R|when it is expired or no longer needed. Consult your pharmacist||
1521|212|R|or local waste disposal company.||
1521|213|B|||
1521|214|M|MEDICAL ALERT:  Your condition can cause complications in a||
1521|215|M|medical emergency. For information about enrolling in MedicAlert,||
1521|216|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1521|217|B|||
1521|218|A|Information last revised November 2025.||
1521|219|A|Copyright(c) 2025 First Databank, Inc.||
1521|220|B|||
1522|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1522|002|Z|does NOT have all possible information about this product. This||
1522|003|Z|information does not assure that this product is safe, effective,||
1522|004|Z|or appropriate for you. This information is not individual||
1522|005|Z|medical advice and does not substitute for the advice of your||
1522|006|Z|health care professional. Always ask your health care||
1522|007|Z|professional for complete information about this product and your||
1522|008|Z|specific health needs.||
1522|009|B|||
1522|010|T|LOTEPREDNOL GEL - OPHTHALMIC||
1522|011|F|(LOE-te-PRED-nol)||
1522|012|B|||
1522|013|C|COMMON BRAND NAME(S): Lotemax||
1522|014|B|||
1522|015|U|USES:  This medication is used to treat eye inflammation and pain||
1522|016|U|after eye surgery. Loteprednol works by relieving symptoms such||
1522|017|U|as swelling, redness, and itching. It belongs to a class of drugs||
1522|018|U|known as corticosteroids.||
1522|019|B|||
1522|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1522|021|H|directed by your doctor, usually 4 times a day.||
1522|022|H|   Do not wear contact lenses while you are using this||
1522|023|H|medication. Sterilize contact lenses according to the||
1522|024|H|manufacturer's directions, and check with your doctor before you||
1522|025|H|begin using them again.||
1522|026|H|   To apply the eye gel, wash your hands first. To avoid||
1522|027|H|contamination, do not touch the bottle tip or let it touch your||
1522|028|H|eye or any other surface. Turn the bottle upside down and shake||
1522|029|H|once to fill the tip with the gel. Gently pull down the lower||
1522|030|H|eyelid to make a pouch. Place the prescribed number of drops into||
1522|031|H|the pouch. Gently close the eye and roll the eyeball in all||
1522|032|H|directions to spread the medication. Try not to blink or rub your||
1522|033|H|eye.||
1522|034|H|   Repeat these steps for your other eye if so directed.||
1522|035|H|   If you are using another kind of eye medication (for example,||
1522|036|H|drops, ointments, or other gels), wait at least 5 to 10 minutes||
1522|037|H|before applying other medications. Use eye drops before eye||
1522|038|H|ointments or gels to allow the drops to enter the eye.||
1522|039|H|   Wait several minutes for your vision to clear before driving||
1522|040|H|or operating machinery.||
1522|041|H|   Use this medication regularly to get the most benefit from it.||
1522|042|H|To help you remember, use it at the same times each day.||
1522|043|H|   The dosage and length of treatment are based on your medical||
1522|044|H|condition and response to treatment. Do not increase your dose or||
1522|045|H|use this drug more often than prescribed. Your condition will not||
1522|046|H|improve any faster, and your risk of side effects will increase.||
1522|047|H|   Continue to use this medication for the full time prescribed.||
1522|048|H|Do not stop using this medication without consulting your doctor.||
1522|049|H|Some conditions may become worse when this drug is suddenly||
1522|050|H|stopped. Your dose may need to be gradually decreased.||
1522|051|H|   Do not use this product if it becomes contaminated (for||
1522|052|H|example, the gel turns a dark color or develops particles in it).||
1522|053|H|Using contaminated eye medication can cause infection, serious||
1522|054|H|damage to the eye, and loss of vision. Ask your doctor or||
1522|055|H|pharmacist for more information.||
1522|056|H|   Tell your doctor if your condition does not get better after a||
1522|057|H|few days or if it gets worse.||
1522|058|B|||
1522|059|S|SIDE EFFECTS:  Temporary blurred vision may occur when you apply||
1522|060|S|this medication. A feeling as if something is in your eye may||
1522|061|S|also occur. If these effects last or get worse, tell your doctor||
1522|062|S|or pharmacist promptly.||
1522|063|S|   Remember that this medication has been prescribed because your||
1522|064|S|doctor has judged that the benefit to you is greater than the||
1522|065|S|risk of side effects. Many people using this medication do not||
1522|066|S|have serious side effects.||
1522|067|S|   Using this medication for prolonged periods or in high doses||
1522|068|S|may cause serious side effects, including serious eye problems||
1522|069|S|(such as cataracts and high pressure inside the eyes). Tell your||
1522|070|S|doctor right away if you have any serious side effects,||
1522|071|S|including: vision problems/changes, eye pain, headache,||
1522|072|S|dizziness.||
1522|073|S|   This medication may mask the signs of an eye infection. It may||
1522|074|S|also put you at greater risk of developing an eye infection,||
1522|075|S|especially with prolonged use. Report right away any new or||
1522|076|S|worsening symptoms such as eye||
1522|077|S|discharge/swelling/redness/itching/pain, vision problems/changes,||
1522|078|S|or no improvement of your current eye condition. Your doctor will||
1522|079|S|need to adjust your treatment.||
1522|080|S|   A very serious allergic reaction to this drug is rare.||
1522|081|S|However, get medical help right away if you notice any symptoms||
1522|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1522|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1522|084|S|breathing.||
1522|085|S|   This is not a complete list of possible side effects. If you||
1522|086|S|notice other effects not listed above, contact your doctor or||
1522|087|S|pharmacist.||
1522|088|S|   In the US -||
1522|089|S|   Call your doctor for medical advice about side effects. You||
1522|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1522|091|S|www.fda.gov/medwatch.||
1522|092|S|   In Canada - Call your doctor for medical advice about side||
1522|093|S|effects. You may report side effects to Health Canada at||
1522|094|S|1-866-234-2345.||
1522|095|B|||
1522|096|P|PRECAUTIONS:  Before using loteprednol, tell your doctor or||
1522|097|P|pharmacist if you are allergic to it; or if you have any other||
1522|098|P|allergies. This product may contain inactive ingredients, which||
1522|099|P|can cause allergic reactions or other problems. Talk to your||
1522|100|P|pharmacist for more details.||
1522|101|P|   Before using this medication, tell your doctor or pharmacist||
1522|102|P|your medical history, especially of: eye infections, cataracts,||
1522|103|P|glaucoma, severe nearsightedness (myopia), diabetes.||
1522|104|P|   After you apply this drug, your vision may become temporarily||
1522|105|P|blurred. Do not drive, use machinery, or do anything that needs||
1522|106|P|clear vision until you can do it safely.||
1522|107|P|   Before having surgery, tell your doctor or dentist about all||
1522|108|P|the products you use (including prescription drugs,||
1522|109|P|nonprescription drugs, and herbal products).||
1522|110|P|   If you develop a new eye infection or injury, or require eye||
1522|111|P|surgery, ask your doctor if you should continue to use your||
1522|112|P|current bottle of loteprednol eye gel or start a new bottle.||
1522|113|P|   During pregnancy, this medication should be used only when||
1522|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
1522|115|P|   It is unknown if the medication in this product passes into||
1522|116|P|breast milk. Consult your doctor before breastfeeding.||
1522|117|B|||
1522|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1522|119|I|medications work or increase your risk for serious side effects.||
1522|120|I|This document does not contain all possible drug interactions.||
1522|121|I|Keep a list of all the products you use (including||
1522|122|I|prescription/nonprescription drugs and herbal products) and share||
1522|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
1522|124|I|the dosage of any medicines without your doctor's approval.||
1522|125|B|||
1522|126|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1522|127|O|has overdosed and has serious symptoms such as passing out or||
1522|128|O|trouble breathing, call 911. Otherwise, call a poison control||
1522|129|O|center right away. US residents can call 1-800-222-1222. Canada||
1522|130|O|residents can call 1-844-764-7669.||
1522|131|B|||
1522|132|N|NOTES:  Do not share this medication with others.||
1522|133|N|   This medication has been prescribed for your current condition||
1522|134|N|only. Do not use it later for another eye condition unless your||
1522|135|N|doctor directs you to do so. A different medication may be||
1522|136|N|necessary in that case.||
1522|137|N|   Lab and/or medical tests (such as eye exams, measurement of||
1522|138|N|the pressure inside the eyes) may be done while you are using||
1522|139|N|this medication. Keep all medical and lab appointments. Consult||
1522|140|N|your doctor for more details.||
1522|141|B|||
1522|142|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1522|143|D|If it is near the time of the next dose, skip the missed dose.||
1522|144|D|Use your next dose at the regular time. Do not double the dose to||
1522|145|D|catch up.||
1522|146|B|||
1522|147|R|STORAGE:  Store upright at room temperature. Keep all medications||
1522|148|R|away from children and pets.||
1522|149|R|   Do not flush medications down the toilet or pour them into a||
1522|150|R|drain unless instructed to do so. Properly discard this product||
1522|151|R|when it is expired or no longer needed. Consult your pharmacist||
1522|152|R|or local waste disposal company.||
1522|153|B|||
1522|154|A|Information last revised November 2024.||
1522|155|A|Copyright(c) 2025 First Databank, Inc.||
1522|156|B|||
1523|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1523|002|Z|does NOT have all possible information about this product. This||
1523|003|Z|information does not assure that this product is safe, effective,||
1523|004|Z|or appropriate for you. This information is not individual||
1523|005|Z|medical advice and does not substitute for the advice of your||
1523|006|Z|health care professional. Always ask your health care||
1523|007|Z|professional for complete information about this product and your||
1523|008|Z|specific health needs.||
1523|009|B|||
1523|010|T|POMALIDOMIDE - ORAL||
1523|011|F|(POE-ma-LID-oh-mide)||
1523|012|B|||
1523|013|C|COMMON BRAND NAME(S): Pomalyst||
1523|014|B|||
1523|015|W|WARNING:  Pomalidomide can cause severe birth defects or death in||
1523|016|W|unborn babies if taken during pregnancy. It is important to||
1523|017|W|prevent pregnancy while taking this medication. Women must use 2||
1523|018|W|reliable forms of birth control or avoid sexual intercourse for 4||
1523|019|W|weeks before starting treatment, during treatment and breaks, and||
1523|020|W|for at least 4 weeks after stopping treatment. Women must also||
1523|021|W|have 2 negative pregnancy tests before starting treatment, the||
1523|022|W|first test 10 to 14 days before the first dose and the second||
1523|023|W|test within 24 hours before the first dose. Women must also||
1523|024|W|continue to have pregnancy tests regularly during treatment. (See||
1523|025|W|also Notes section.) If you become pregnant or think you may be||
1523|026|W|pregnant, stop taking pomalidomide and tell your doctor right||
1523|027|W|away. Consult your doctor or pharmacist for more information.||
1523|028|W|   Men who are taking pomalidomide must use latex or synthetic||
1523|029|W|condoms during any sexual contact with female partners while on||
1523|030|W|treatment, during breaks, and for at least 4 weeks after stopping||
1523|031|W|treatment even if they have had a vasectomy. If your partner||
1523|032|W|becomes pregnant or thinks she may be pregnant, tell your doctor||
1523|033|W|right away.||
1523|034|W|   To receive pomalidomide in the United States, you must||
1523|035|W|understand, agree to, and carefully follow the requirements of||
1523|036|W|the REMS Program for this medication. If you live in Canada or||
1523|037|W|any other country, consult your doctor and pharmacist for your||
1523|038|W|country's regulations.||
1523|039|W|   This medication may rarely cause serious (sometimes fatal)||
1523|040|W|problems from blood clots (such as heart attack, stroke, blood||
1523|041|W|clots in the lungs or legs). Get medical help right away if you||
1523|042|W|have: chest/jaw/left arm pain, unusual sweating, weakness on one||
1523|043|W|side of the body, sudden vision changes, trouble speaking,||
1523|044|W|pain/swelling/warmth in the groin/calf, shortness of breath/rapid||
1523|045|W|breathing, confusion, sudden dizziness/fainting, or sudden/severe||
1523|046|W|headaches. Your doctor should prescribe you medications such as||
1523|047|W|"blood thinners" (examples include aspirin, warfarin) to prevent||
1523|048|W|blood clots.||
1523|049|B|||
1523|050|U|USES:  Pomalidomide is used to treat certain types of cancers||
1523|051|U|(such as multiple myeloma, Kaposi sarcoma). It works by slowing||
1523|052|U|or stopping the growth of cancer cells.||
1523|053|B|||
1523|054|H|HOW TO USE:  Read the Medication Guide provided by your||
1523|055|H|pharmacist before you start taking pomalidomide and each time you||
1523|056|H|get a refill. If you have any questions, ask your doctor or||
1523|057|H|pharmacist.||
1523|058|H|   Take this medication by mouth with or without food as directed||
1523|059|H|by your doctor, usually once daily for 21 days, then stopping the||
1523|060|H|medication for 7 days. This is one cycle of treatment. Keep||
1523|061|H|taking the medication this way as directed by your doctor.||
1523|062|H|   Swallow the capsules whole with water. Do not open, break,||
1523|063|H|crush or chew the capsules or handle them more than needed. If||
1523|064|H|any of the powder from the capsule gets on your skin, wash the||
1523|065|H|area with soap and water.||
1523|066|H|   The dosage is based on your medical condition, response to||
1523|067|H|treatment, lab tests, and other medications you may be taking. Be||
1523|068|H|sure to tell your doctor and pharmacist about all the products||
1523|069|H|you use (including prescription drugs, nonprescription drugs, and||
1523|070|H|herbal products).||
1523|071|H|   Take this medication regularly to get the most benefit from||
1523|072|H|it. Remember to take it at the same time each day that you are||
1523|073|H|scheduled to take it.||
1523|074|H|   Do not increase your dose or take this drug more often or for||
1523|075|H|longer than prescribed. Your condition will not improve any||
1523|076|H|faster, and your risk of side effects will increase.||
1523|077|H|   Since this drug can be absorbed through the skin and lungs and||
1523|078|H|may harm an unborn baby, women who are pregnant or who may become||
1523|079|H|pregnant should not handle this medication or breathe the dust||
1523|080|H|from the capsules.||
1523|081|B|||
1523|082|S|SIDE EFFECTS:  See also Warning section.||
1523|083|S|   Dizziness, confusion, tiredness, weakness, constipation,||
1523|084|S|diarrhea, back/bone pain, muscle pain/cramps, nausea, vomiting,||
1523|085|S|and loss of appetite may occur. If any of these effects last or||
1523|086|S|get worse, tell your doctor or pharmacist promptly.||
1523|087|S|   People using this medication may have serious side effects.||
1523|088|S|However, you have been prescribed this drug because your doctor||
1523|089|S|has judged that the benefit to you is greater than the risk of||
1523|090|S|side effects. Careful monitoring by your doctor may decrease your||
1523|091|S|risk.||
1523|092|S|   Tell your doctor right away if you have any serious side||
1523|093|S|effects, including: numbness/tingling/swelling of the||
1523|094|S|arms/legs/hands/feet, shortness of breath.||
1523|095|S|   This medication decreases bone marrow function, an effect that||
1523|096|S|may lead to a low number of blood cells such as red cells, white||
1523|097|S|cells, and platelets. This effect can cause anemia, decrease your||
1523|098|S|body's ability to fight an infection, or cause easy||
1523|099|S|bruising/bleeding. Get medical help right away if you have any of||
1523|100|S|the following symptoms: unusual tiredness, pale skin, easy||
1523|101|S|bruising/bleeding, signs of infection (such as sore throat that||
1523|102|S|doesn't go away, fever, chills, swollen lymph nodes).||
1523|103|S|   Pomalidomide sometimes causes side effects due to the rapid||
1523|104|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1523|105|S|risk, your doctor may add a medication and tell you to drink||
1523|106|S|plenty of fluids. Tell your doctor right away if you have||
1523|107|S|symptoms such as: low back/side pain (flank pain), signs of||
1523|108|S|kidney problems (such as painful urination, pink/bloody urine,||
1523|109|S|change in the amount of urine), muscle spasms/weakness.||
1523|110|S|   This medication may increase your risk of getting a rare but||
1523|111|S|very serious (possibly fatal) brain infection (progressive||
1523|112|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1523|113|S|if you have any of these side effects: clumsiness, loss of||
1523|114|S|coordination/balance, weakness, sudden change in your thinking||
1523|115|S|(such as confusion, difficulty concentrating, memory loss),||
1523|116|S|difficulty talking/walking, seizure, vision changes.||
1523|117|S|   Pomalidomide has rarely caused very serious (possibly fatal)||
1523|118|S|liver disease. Get medical help right away if you develop||
1523|119|S|symptoms of liver disease, including: nausea/vomiting that||
1523|120|S|doesn't stop, severe stomach/abdominal pain, dark urine,||
1523|121|S|yellowing eyes/skin.||
1523|122|S|   People who are treated with this medication may rarely get||
1523|123|S|other cancers (such as leukemia). Consult your doctor for more||
1523|124|S|details.||
1523|125|S|   A very serious allergic reaction to this drug is rare.||
1523|126|S|However, get medical help right away if you notice any symptoms||
1523|127|S|of a serious allergic reaction, including: rash, itching/swelling||
1523|128|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1523|129|S|breathing.||
1523|130|S|   This is not a complete list of possible side effects. If you||
1523|131|S|notice other effects not listed above, contact your doctor or||
1523|132|S|pharmacist.||
1523|133|S|   In the US -||
1523|134|S|   Call your doctor for medical advice about side effects. You||
1523|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1523|136|S|www.fda.gov/medwatch.||
1523|137|S|   In Canada - Call your doctor for medical advice about side||
1523|138|S|effects. You may report side effects to Health Canada at||
1523|139|S|1-866-234-2345.||
1523|140|B|||
1523|141|P|PRECAUTIONS:  Before taking pomalidomide, tell your doctor or||
1523|142|P|pharmacist if you are allergic to it; or to thalidomide or||
1523|143|P|lenalidomide; or if you have any other allergies. This product||
1523|144|P|may contain inactive ingredients which can cause allergic||
1523|145|P|reactions or other problems. Talk to your pharmacist for more||
1523|146|P|details.||
1523|147|P|   Before using this medication, tell your doctor or pharmacist||
1523|148|P|your medical history, especially of: kidney disease, liver||
1523|149|P|disease, cigarette smoking, heart disease (such as heart attack),||
1523|150|P|blood clots, stroke.||
1523|151|P|   Pomalidomide can make you more likely to get infections or may||
1523|152|P|make current infections worse. Stay away from anyone who has an||
1523|153|P|infection that may easily spread (such as chickenpox, COVID-19,||
1523|154|P|measles, flu). Talk to your doctor if you have been exposed to an||
1523|155|P|infection or for more details.||
1523|156|P|   Tell your health care professional that you are using||
1523|157|P|pomalidomide before having any immunizations/vaccinations. Avoid||
1523|158|P|contact with people who have recently received live vaccines||
1523|159|P|(such as flu vaccine inhaled through the nose).||
1523|160|P|   To lower the chance of getting cut, bruised, or injured, use||
1523|161|P|caution with sharp objects like razors and nail cutters, and||
1523|162|P|avoid activities such as contact sports.||
1523|163|P|   This drug may make you dizzy or confused. Alcohol or marijuana||
1523|164|P|(cannabis) can make you more dizzy or confused. Do not drive, use||
1523|165|P|machinery, or do anything that needs alertness until you can do||
1523|166|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1523|167|P|are using marijuana (cannabis).||
1523|168|P|   Before having surgery, tell your doctor or dentist about all||
1523|169|P|the products you use (including prescription drugs,||
1523|170|P|nonprescription drugs, and herbal products).||
1523|171|P|   Because pomalidomide can cause severe birth defects or death||
1523|172|P|to an unborn baby, several precautions are noted below.||
1523|173|P|   Do not donate blood during treatment and for at least 1 month||
1523|174|P|after stopping treatment.||
1523|175|P|   Men: Do not donate sperm during treatment and for at least 4||
1523|176|P|weeks after stopping treatment because pomalidomide passes into||
1523|177|P|semen.||
1523|178|P|   Women: Tell your doctor right away if your period is late or||
1523|179|P|if you have abnormal vaginal (menstrual) bleeding. Use reliable||
1523|180|P|forms of birth control even if you were unable to get pregnant in||
1523|181|P|the past.||
1523|182|P|   Since this drug can be absorbed through the skin and lungs and||
1523|183|P|may harm an unborn baby, women who are pregnant or who may become||
1523|184|P|pregnant should not handle this medication or breathe the dust||
1523|185|P|from the capsules.||
1523|186|P|   This medication must not be used during pregnancy. It may harm||
1523|187|P|an unborn baby. See also Warning section.||
1523|188|P|   It is unknown if this drug passes into breast milk. Because of||
1523|189|P|the possible risk to the infant, breastfeeding is not recommended||
1523|190|P|while using this drug. Consult your doctor before breastfeeding.||
1523|191|B|||
1523|192|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1523|193|I|medications work or increase your risk for serious side effects.||
1523|194|I|This document does not contain all possible drug interactions.||
1523|195|I|Keep a list of all the products you use (including||
1523|196|I|prescription/nonprescription drugs and herbal products) and share||
1523|197|I|it with your doctor and pharmacist. Do not start, stop, or change||
1523|198|I|the dosage of any medicines without your doctor's approval.||
1523|199|I|   Tell your doctor or pharmacist if you are taking other||
1523|200|I|products that cause dizziness or confusion including alcohol,||
1523|201|I|marijuana (cannabis), antihistamines (such as diphenhydramine),||
1523|202|I|drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle||
1523|203|I|relaxants, and opioid pain relievers (such as codeine).||
1523|204|I|   Check the labels on all your medicines (such as allergy or||
1523|205|I|cough-and-cold products) because they may contain ingredients||
1523|206|I|that cause dizziness. Ask your pharmacist about using those||
1523|207|I|products safely.||
1523|208|I|   Cigarette smoking decreases blood levels of this medication.||
1523|209|I|Tell your doctor if you smoke or if you have recently stopped||
1523|210|I|smoking.||
1523|211|B|||
1523|212|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1523|213|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1523|214|O|poison control center right away. US residents can call||
1523|215|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1523|216|B|||
1523|217|N|NOTES:  Do not share this medication with others.||
1523|218|N|   Lab and/or medical tests (such as pregnancy tests, blood||
1523|219|N|counts, liver function) must be done before you start taking this||
1523|220|N|medication and while you are taking it. Keep all medical and lab||
1523|221|N|appointments. Consult your doctor for more details.||
1523|222|N|   Test for pregnancy before treatment, and weekly during the||
1523|223|N|first 4 weeks of treatment. If you have regular periods, then||
1523|224|N|test every 4 weeks thereafter. If you have irregular periods, you||
1523|225|N|should test every 2 weeks thereafter.||
1523|226|B|||
1523|227|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1523|228|D|remember. If it is more than 12 hours after the missed dose, skip||
1523|229|D|the missed dose. Take your next dose at the regular time. Do not||
1523|230|D|double the dose to catch up.||
1523|231|B|||
1523|232|R|STORAGE:  Store at room temperature away from light and moisture.||
1523|233|R|Do not store in the bathroom. Keep all medications away from||
1523|234|R|children and pets.||
1523|235|R|   Do not flush medications down the toilet or pour them into a||
1523|236|R|drain unless instructed to do so. Properly discard this product||
1523|237|R|when it is expired or no longer needed. Consult your pharmacist||
1523|238|R|or local waste disposal company.||
1523|239|B|||
1523|240|M|MEDICAL ALERT:  Your condition can cause complications in a||
1523|241|M|medical emergency. For information about enrolling in MedicAlert,||
1523|242|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1523|243|B|||
1523|244|A|Information last revised April 2025.||
1523|245|A|Copyright(c) 2025 First Databank, Inc.||
1523|246|B|||
1524|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1524|002|Z|does NOT have all possible information about this product. This||
1524|003|Z|information does not assure that this product is safe, effective,||
1524|004|Z|or appropriate for you. This information is not individual||
1524|005|Z|medical advice and does not substitute for the advice of your||
1524|006|Z|health care professional. Always ask your health care||
1524|007|Z|professional for complete information about this product and your||
1524|008|Z|specific health needs.||
1524|009|B|||
1524|010|T|TRASTUZUMAB EMTANSINE - INJECTION||
1524|011|F|(tras-TOOZ-ue-mab em-TAN-seen)||
1524|012|B|||
1524|013|C|COMMON BRAND NAME(S): Kadcyla||
1524|014|B|||
1524|015|W|WARNING:  Trastuzumab emtansine has rarely caused very serious||
1524|016|W|(possibly fatal) liver disease. Get medical help right away if||
1524|017|W|you develop symptoms of liver disease, including nausea that||
1524|018|W|doesn't stop, severe stomach/abdominal pain, dark urine,||
1524|019|W|yellowing eyes/skin.||
1524|020|W|   Trastuzumab emtansine may lead to serious heart problems,||
1524|021|W|including heart failure. Past use of certain other anti-cancer||
1524|022|W|drugs (including anthracyclines such as doxorubicin) may increase||
1524|023|W|your risk of heart problems. Tell your doctor right away if you||
1524|024|W|have any symptoms of heart failure, including shortness of||
1524|025|W|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
1524|026|W|weight gain.||
1524|027|W|   Trastuzumab emtansine can cause serious (possibly fatal) harm||
1524|028|W|to an unborn baby if used during pregnancy. Discuss reliable||
1524|029|W|forms of birth control with your doctor.||
1524|030|B|||
1524|031|U|USES:  Trastuzumab emtansine is used to treat breast cancer. This||
1524|032|U|medication is called a monoclonal antibody and microtubule||
1524|033|U|inhibitor conjugate. It works by slowing or stopping the growth||
1524|034|U|of cancer cells.||
1524|035|U|   This monograph is about the following trastuzumab emtansine||
1524|036|U|products: trastuzumab emtansine, ado-trastuzumab emtansine.||
1524|037|B|||
1524|038|H|HOW TO USE:  This medication is given by slow injection into a||
1524|039|H|vein by a health care professional. It is given as directed by||
1524|040|H|your doctor, usually once every 3 weeks. Your first infusion will||
1524|041|H|be given over at least 90 minutes.||
1524|042|H|   The dosage, the speed of your injection, and the length of||
1524|043|H|time you receive trastuzumab emtansine is based on your body||
1524|044|H|weight, medical condition, and response to treatment.||
1524|045|H|   Infusion reactions may happen during the infusion of this drug||
1524|046|H|and for up to 24 hours afterward. Your doctor may prescribe other||
1524|047|H|medications (such as acetaminophen, diphenhydramine) before each||
1524|048|H|treatment to help prevent these side effects. Tell your doctor||
1524|049|H|right away if you have any symptoms of infusion reactions such as||
1524|050|H|chills, fever, flushing, wheezing, shortness of breath,||
1524|051|H|dizziness, or fast heartbeat. Your doctor may slow down or stop||
1524|052|H|your treatment for some time.||
1524|053|H|   To get the most benefit from this medication, do not miss any||
1524|054|H|doses. To help you remember, mark your calendar with a reminder.||
1524|055|B|||
1524|056|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1524|057|S|   Diarrhea, dizziness, muscle/joint/back pain, stomach/abdominal||
1524|058|S|pain, constipation, trouble sleeping, nausea, vomiting, mouth||
1524|059|S|sores, dry mouth, changes in taste, and loss of appetite may||
1524|060|S|occur. Nausea and vomiting can be severe. In some cases, your||
1524|061|S|doctor may prescribe medication to prevent or relieve nausea and||
1524|062|S|vomiting. Eating several small meals, not eating before||
1524|063|S|treatment, or limiting activity may help lessen some of these||
1524|064|S|effects. If any of these effects last or get worse, tell your||
1524|065|S|doctor or pharmacist promptly.||
1524|066|S|   Remember that this medication has been prescribed because your||
1524|067|S|doctor has judged that the benefit to you is greater than the||
1524|068|S|risk of side effects. Many people using this medication do not||
1524|069|S|have serious side effects.||
1524|070|S|   Tell your doctor right away if you have any serious side||
1524|071|S|effects, including: pain/swelling/redness/irritation at the||
1524|072|S|injection site, bone pain, increased coughing, swelling of the||
1524|073|S|hands/ankles/feet, unusual tiredness, severe headache,||
1524|074|S|tingling/numbness (such as in the hands, feet, leg), mental/mood||
1524|075|S|changes, fast/pounding heartbeat, muscle cramps, easy||
1524|076|S|bruising/bleeding.||
1524|077|S|   This drug has caused very serious (rarely fatal) bleeding. Get||
1524|078|S|medical help right away if you develop symptoms of very serious||
1524|079|S|bleeding, including: weakness on one side of the body, trouble||
1524|080|S|speaking, vision changes, confusion, severe stomach/abdominal||
1524|081|S|pain, trouble breathing, vomit that is bloody or looks like||
1524|082|S|coffee grounds, black/tarry stool.||
1524|083|S|   This medication may lower your ability to fight infections.||
1524|084|S|This may make you more likely to get a serious (rarely fatal)||
1524|085|S|infection or make any infection you have worse. Tell your doctor||
1524|086|S|right away if you have any signs of infection (such as sore||
1524|087|S|throat that doesn't go away, fever, chills).||
1524|088|S|   Trastuzumab emtansine can commonly cause a rash that is||
1524|089|S|usually not serious. However, you may not be able to tell it||
1524|090|S|apart from a rare rash that could be a sign of a severe reaction.||
1524|091|S|Get medical help right away if you develop any rash.||
1524|092|S|   A very serious allergic reaction to this drug is rare.||
1524|093|S|However, get medical help right away if you notice any symptoms||
1524|094|S|of a serious allergic reaction, including: rash, itching/swelling||
1524|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1524|096|S|breathing.||
1524|097|S|   This is not a complete list of possible side effects. If you||
1524|098|S|notice other effects not listed above, contact your doctor or||
1524|099|S|pharmacist.||
1524|100|S|   In the US -||
1524|101|S|   Call your doctor for medical advice about side effects. You||
1524|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1524|103|S|www.fda.gov/medwatch.||
1524|104|S|   In Canada - Call your doctor for medical advice about side||
1524|105|S|effects. You may report side effects to Health Canada at||
1524|106|S|1-866-234-2345.||
1524|107|B|||
1524|108|P|PRECAUTIONS:  See also Warning section.||
1524|109|P|   Before using trastuzumab emtansine, tell your doctor or||
1524|110|P|pharmacist if you are allergic to it; or to any trastuzumab||
1524|111|P|deruxtecan, trastuzumab emtansine, trastuzumab, or||
1524|112|P|trastuzumab-hyaluronidase products; or if you have any other||
1524|113|P|allergies. This product may contain inactive ingredients which||
1524|114|P|can cause allergic reactions or other problems. Talk to your||
1524|115|P|pharmacist for more details.||
1524|116|P|   Before using this medication, tell your doctor or pharmacist||
1524|117|P|your medical history, especially of: previous cancer treatments||
1524|118|P|(including radiation therapy to the chest), current infection,||
1524|119|P|heart disease, high blood pressure, lung problems, previous||
1524|120|P|severe reaction to monoclonal antibody treatment, liver disease||
1524|121|P|(including a rare liver condition called nodular regenerative||
1524|122|P|hyperplasia).||
1524|123|P|   Trastuzumab emtansine can make you more likely to get||
1524|124|P|infections or may make current infections worse. Stay away from||
1524|125|P|anyone who has an infection that may easily spread (such as||
1524|126|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
1524|127|P|have been exposed to an infection or for more details.||
1524|128|P|   Tell your health care professional that you are using||
1524|129|P|trastuzumab emtansine before having any||
1524|130|P|immunizations/vaccinations. Avoid contact with people who have||
1524|131|P|recently received live vaccines (such as flu vaccine inhaled||
1524|132|P|through the nose).||
1524|133|P|   To lower the chance of getting cut, bruised, or injured, use||
1524|134|P|caution with sharp objects like razors and nail cutters, and||
1524|135|P|avoid activities such as contact sports.||
1524|136|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1524|137|P|can make you more dizzy. Do not drive, use machinery, or do||
1524|138|P|anything that needs alertness until you can do it safely. Limit||
1524|139|P|alcoholic beverages. Talk to your doctor if you are using||
1524|140|P|marijuana (cannabis).||
1524|141|P|   Before having surgery, tell your doctor or dentist about all||
1524|142|P|the products you use (including prescription drugs,||
1524|143|P|nonprescription drugs, and herbal products).||
1524|144|P|   Older adults may be more sensitive to the side effects of this||
1524|145|P|drug, especially heart problems (such as heart failure).||
1524|146|P|   Tell your doctor if you are pregnant or plan to become||
1524|147|P|pregnant. You should not become pregnant while using trastuzumab||
1524|148|P|emtansine. Trastuzumab emtansine may harm an unborn baby. Your||
1524|149|P|doctor should order a pregnancy test before you start this||
1524|150|P|medication. Women using this medication should ask about reliable||
1524|151|P|forms of birth control during treatment and for 7 months after||
1524|152|P|the last dose. Men using this medication should ask about||
1524|153|P|reliable forms of birth control during treatment and for 4 months||
1524|154|P|after the last dose. If you or your partner becomes pregnant,||
1524|155|P|talk to your doctor right away about the risks and benefits of||
1524|156|P|this medication.||
1524|157|P|   It is unknown if this drug passes into breast milk. Because of||
1524|158|P|the possible risk to the infant, breastfeeding is not recommended||
1524|159|P|while using this drug and for 7 months after the last dose.||
1524|160|P|Consult your doctor before breastfeeding.||
1524|161|B|||
1524|162|I|DRUG INTERACTIONS:  See also Warning section.||
1524|163|I|   Drug interactions may change how your medications work or||
1524|164|I|increase your risk for serious side effects. This document does||
1524|165|I|not contain all possible drug interactions. Keep a list of all||
1524|166|I|the products you use (including prescription/nonprescription||
1524|167|I|drugs and herbal products) and share it with your doctor and||
1524|168|I|pharmacist. Do not start, stop, or change the dosage of any||
1524|169|I|medicines without your doctor's approval.||
1524|170|I|   If you will be using an anthracycline (such as doxorubicin)||
1524|171|I|after stopping trastuzumab emtansine treatment, if possible, wait||
1524|172|I|at least 7 months.||
1524|173|I|   Other medications can affect the removal of trastuzumab||
1524|174|I|emtansine from your body, which may affect how trastuzumab||
1524|175|I|emtansine works. Examples include azole antifungals (such as||
1524|176|I|itraconazole, ketoconazole), clarithromycin, nefazodone, HIV||
1524|177|I|protease inhibitors (such as atazanavir), ritonavir,||
1524|178|I|telithromycin, among others.||
1524|179|I|   Trastuzumab emtansine is very similar to trastuzumab,||
1524|180|I|trastuzumab deruxtecan, and trastuzumab-hyaluronidase. Do not use||
1524|181|I|a trastuzumab, trastuzumab deruxtecan, or||
1524|182|I|trastuzumab-hyaluronidase product while using a trastuzumab||
1524|183|I|emtansine product.||
1524|184|B|||
1524|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1524|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1524|187|O|poison control center right away. US residents can call||
1524|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1524|189|B|||
1524|190|N|NOTES:  Do not share this medication with others.||
1524|191|N|   Lab and/or medical tests (such as heart exams, platelet||
1524|192|N|counts, liver function, bilirubin level) should be done before||
1524|193|N|you start using this medication and while you are using it. Keep||
1524|194|N|all medical and lab appointments. Consult your doctor for more||
1524|195|N|details.||
1524|196|B|||
1524|197|D|MISSED DOSE:  It is important to get each dose of this medication||
1524|198|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1524|199|D|right away for a new dosing schedule.||
1524|200|B|||
1524|201|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1524|202|R|hospital and will not be stored at home.||
1524|203|B|||
1524|204|M|MEDICAL ALERT:  Your condition can cause complications in a||
1524|205|M|medical emergency. For information about enrolling in MedicAlert,||
1524|206|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1524|207|B|||
1524|208|A|Information last revised April 2025.||
1524|209|A|Copyright(c) 2025 First Databank, Inc.||
1524|210|B|||
1525|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1525|002|Z|does NOT have all possible information about this product. This||
1525|003|Z|information does not assure that this product is safe, effective,||
1525|004|Z|or appropriate for you. This information is not individual||
1525|005|Z|medical advice and does not substitute for the advice of your||
1525|006|Z|health care professional. Always ask your health care||
1525|007|Z|professional for complete information about this product and your||
1525|008|Z|specific health needs.||
1525|009|B|||
1525|010|T|GLYCOPYRROLATE POWDER IN CAPSULE - INHALATION||
1525|011|F|(GLYE-koe-PIR-oh-late)||
1525|012|B|||
1525|013|C|COMMON BRAND NAME(S): Seebri Neohaler||
1525|014|B|||
1525|015|U|USES:  Glycopyrrolate is a long term medication used to treat||
1525|016|U|ongoing lung disease such as chronic obstructive pulmonary||
1525|017|U|disease (COPD), including chronic bronchitis and emphysema. It||
1525|018|U|must be used regularly to reduce and prevent symptoms such as||
1525|019|U|shortness of breath and wheezing. This may lead to a decrease in||
1525|020|U|time lost from work due to COPD. This medication belongs to a||
1525|021|U|class of drugs known as anticholinergics. It works by relaxing||
1525|022|U|the muscles around the airways so that they open up and you can||
1525|023|U|breathe more easily.||
1525|024|U|   Glycopyrrolate does not work right away and should not be used||
1525|025|U|to relieve sudden breathing problems. If wheezing or sudden||
1525|026|U|shortness of breath occurs, use your quick-relief inhaler as||
1525|027|U|prescribed.||
1525|028|B|||
1525|029|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1525|030|H|your pharmacist before you start using glycopyrrolate and each||
1525|031|H|time you get a refill. Follow the illustrated directions for the||
1525|032|H|proper use of this medication. If you have any questions, ask||
1525|033|H|your doctor or pharmacist.||
1525|034|H|   Do not swallow these capsules. Use only the special inhaler||
1525|035|H|that comes with the medication to inhale the powder in the||
1525|036|H|capsules. Inhale this medication by mouth as directed by your||
1525|037|H|doctor, usually once or twice daily, depending on the brand that||
1525|038|H|you use.||
1525|039|H|   Leave the capsule sealed in the blister packet until just||
1525|040|H|before use. Dry your hands before touching the capsules. Do not||
1525|041|H|push the capsule through the foil. Follow the instructions for||
1525|042|H|loading the capsule into the inhaler and for piercing it. Inhale||
1525|043|H|rapidly and deeply through the mouthpiece. You should hear a||
1525|044|H|whirring noise as you inhale the medication. You will also have a||
1525|045|H|sweet taste from the medicine. Hold your breath for at least 5 to||
1525|046|H|10 seconds. Open the inhaler to see if any powder is left in the||
1525|047|H|capsule. If there is, close the inhaler and inhale again. Inhale||
1525|048|H|all of the powder from each capsule. Do not blow into the||
1525|049|H|mouthpiece at any time.||
1525|050|H|   Avoid getting this medication into your eyes. It may cause eye||
1525|051|H|pain/irritation, temporary blurred vision, and other vision||
1525|052|H|changes.||
1525|053|H|   If you are using other inhalers at the same time, wait at||
1525|054|H|least 1 minute between the use of each medication.||
1525|055|H|   Use this medication regularly to get the most benefit from it.||
1525|056|H|To help you remember, use it at the same time(s) each day. Do not||
1525|057|H|increase your dose or use this drug more often than prescribed,||
1525|058|H|or stop using it without first consulting your doctor.||
1525|059|H|   Do not wash the inhaler with water. You may wipe the||
1525|060|H|mouthpiece inside and outside with a clean, dry, lint-free cloth.||
1525|061|H|   Learn which of your inhalers you should use every day and||
1525|062|H|which you should use if your breathing suddenly worsens||
1525|063|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1525|064|H|should do if you have new or worsening cough or shortness of||
1525|065|H|breath, wheezing, increased sputum, waking up at night with||
1525|066|H|trouble breathing, if you use your quick-relief inhaler more||
1525|067|H|often, or if your quick-relief inhaler does not seem to be||
1525|068|H|working well. Learn when you can treat sudden breathing problems||
1525|069|H|by yourself and when you must get medical help right away.||
1525|070|H|   Tell your doctor if your symptoms do not get better or if they||
1525|071|H|get worse.||
1525|072|B|||
1525|073|S|SIDE EFFECTS:  Dry mouth, dry/sore throat, or runny/stuffy nose||
1525|074|S|may occur. If any of these effects last or get worse, tell your||
1525|075|S|doctor or pharmacist promptly.||
1525|076|S|   Remember that this medication has been prescribed because your||
1525|077|S|doctor has judged that the benefit to you is greater than the||
1525|078|S|risk of side effects. Many people using this medication do not||
1525|079|S|have serious side effects.||
1525|080|S|   Tell your doctor right away if you have any serious side||
1525|081|S|effects, including: difficult/painful urination, fast/irregular||
1525|082|S|heartbeat.||
1525|083|S|   Get medical help right away if you have any very serious side||
1525|084|S|effects, including: eye pain/swelling/redness, vision changes||
1525|085|S|(such as seeing rainbows around lights at night, blurred vision).||
1525|086|S|   Rarely, glycopyrrolate may cause worsening of breathing||
1525|087|S|problems (paradoxical bronchospasm) that may be severe. If this||
1525|088|S|occurs, get medical attention right away.||
1525|089|S|   A very serious allergic reaction to this drug is rare.||
1525|090|S|However, get medical help right away if you notice any symptoms||
1525|091|S|of a serious allergic reaction, including: rash, itching/swelling||
1525|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1525|093|S|breathing.||
1525|094|S|   This is not a complete list of possible side effects. If you||
1525|095|S|notice other effects not listed above, contact your doctor or||
1525|096|S|pharmacist.||
1525|097|S|   In the US -||
1525|098|S|   Call your doctor for medical advice about side effects. You||
1525|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1525|100|S|www.fda.gov/medwatch.||
1525|101|S|   In Canada - Call your doctor for medical advice about side||
1525|102|S|effects. You may report side effects to Health Canada at||
1525|103|S|1-866-234-2345.||
1525|104|B|||
1525|105|P|PRECAUTIONS:  Before using glycopyrrolate, tell your doctor or||
1525|106|P|pharmacist if you are allergic to it; or if you have any other||
1525|107|P|allergies. This product may contain inactive ingredients (such as||
1525|108|P|milk proteins), which can cause allergic reactions or other||
1525|109|P|problems. Talk to your pharmacist for more details.||
1525|110|P|   Before using this medication, tell your doctor or pharmacist||
1525|111|P|your medical history, especially of: personal or family history||
1525|112|P|of glaucoma (angle-closure type), kidney disease, problems with||
1525|113|P|urination (such as urinary tract blockage, enlarged prostate).||
1525|114|P|   This drug may cause blurred vision. Do not drive, use||
1525|115|P|machinery, or do anything that needs clear vision until you can||
1525|116|P|do it safely.||
1525|117|P|   Before having surgery, tell your doctor or dentist about all||
1525|118|P|the products you use (including prescription drugs,||
1525|119|P|nonprescription drugs, and herbal products).||
1525|120|P|   Older adults may be more sensitive to certain effects of this||
1525|121|P|drug, especially headache and burning/painful/frequent/urgent||
1525|122|P|urination.||
1525|123|P|   During pregnancy, this medication should be used only when||
1525|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
1525|125|P|   It is unknown if this medication passes into breast milk.||
1525|126|P|Consult your doctor before breastfeeding.||
1525|127|B|||
1525|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1525|129|I|medications work or increase your risk for serious side effects.||
1525|130|I|This document does not contain all possible drug interactions.||
1525|131|I|Keep a list of all the products you use (including||
1525|132|I|prescription/nonprescription drugs and herbal products) and share||
1525|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
1525|134|I|the dosage of any medicines without your doctor's approval.||
1525|135|B|||
1525|136|O|OVERDOSE:  This medication will not work and may be harmful if||
1525|137|O|swallowed. If someone has overdosed and has serious symptoms such||
1525|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1525|139|O|poison control center right away. US residents can call||
1525|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1525|141|B|||
1525|142|N|NOTES:  Do not share this medication with others.||
1525|143|N|   If you smoke, quitting is the most important step you can take||
1525|144|N|to treat COPD. Talk with your doctor or pharmacist about programs||
1525|145|N|and products that can help you quit.||
1525|146|N|   Because the flu virus can worsen breathing problems, ask your||
1525|147|N|doctor or pharmacist if you should have a flu shot every year.||
1525|148|N|   Lab and/or medical tests (such as lung function) should be||
1525|149|N|done while you are using this medication. Keep all medical and||
1525|150|N|lab appointments. Consult your doctor for more details.||
1525|151|B|||
1525|152|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1525|153|D|If it is near the time of the next dose, skip the missed dose.||
1525|154|D|Use your next dose at the regular time. Do not double the dose to||
1525|155|D|catch up.||
1525|156|B|||
1525|157|R|STORAGE:  Store the capsules and the inhaler in a dry place at||
1525|158|R|room temperature away from heat and moisture. Do not store in the||
1525|159|R|bathroom. Discard the inhaler after 30 days of use. Keep all||
1525|160|R|medications away from children and pets.||
1525|161|R|   Do not flush medications down the toilet or pour them into a||
1525|162|R|drain unless instructed to do so. Properly discard this product||
1525|163|R|when it is expired or no longer needed. Consult your pharmacist||
1525|164|R|or local waste disposal company.||
1525|165|B|||
1525|166|M|MEDICAL ALERT:  Your condition can cause complications in a||
1525|167|M|medical emergency. For information about enrolling in MedicAlert,||
1525|168|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1525|169|B|||
1525|170|A|Information last revised April 2025.||
1525|171|A|Copyright(c) 2025 First Databank, Inc.||
1525|172|B|||
1526|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1526|002|Z|does NOT have all possible information about this product. This||
1526|003|Z|information does not assure that this product is safe, effective,||
1526|004|Z|or appropriate for you. This information is not individual||
1526|005|Z|medical advice and does not substitute for the advice of your||
1526|006|Z|health care professional. Always ask your health care||
1526|007|Z|professional for complete information about this product and your||
1526|008|Z|specific health needs.||
1526|009|B|||
1526|010|T|CROFELEMER - ORAL||
1526|011|F|(kroe-FEL-e-mer)||
1526|012|B|||
1526|013|C|COMMON BRAND NAME(S): Fulyzaq, Mytesi||
1526|014|B|||
1526|015|U|USES:  Crofelemer is used to relieve symptoms of diarrhea in||
1526|016|U|HIV/AIDS patients who are taking medicines to treat HIV||
1526|017|U|infection. This medication may reduce the number of watery stools||
1526|018|U|you have and help you better tolerate your HIV medications. It||
1526|019|U|works by preventing water and minerals from entering into the||
1526|020|U|intestines, causing the stools to be more solid.||
1526|021|U|   Crofelemer should not be used to treat diarrhea caused by||
1526|022|U|infections.||
1526|023|B|||
1526|024|H|HOW TO USE:  Take crofelemer by mouth with or without food as||
1526|025|H|directed by your doctor, usually twice daily.||
1526|026|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1526|027|H|   Take this medication regularly to get the most benefit from||
1526|028|H|it. To help you remember, take it at the same times each day.||
1526|029|H|   It may take up to several months before you get the full||
1526|030|H|benefit of this drug. Tell your doctor if your condition does not||
1526|031|H|get better or if it gets worse.||
1526|032|B|||
1526|033|S|SIDE EFFECTS:  Stuffy/runny nose, cough, sore throat, or sneezing||
1526|034|S|may occur. If any of these effects last or get worse, tell your||
1526|035|S|doctor or pharmacist promptly.||
1526|036|S|   Remember that this medication has been prescribed because your||
1526|037|S|doctor has judged that the benefit to you is greater than the||
1526|038|S|risk of side effects. Many people using this medication do not||
1526|039|S|have serious side effects.||
1526|040|S|   A very serious allergic reaction to this drug is rare.||
1526|041|S|However, get medical help right away if you notice any symptoms||
1526|042|S|of a serious allergic reaction, including: rash, itching/swelling||
1526|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1526|044|S|breathing.||
1526|045|S|   This is not a complete list of possible side effects. If you||
1526|046|S|notice other effects not listed above, contact your doctor or||
1526|047|S|pharmacist.||
1526|048|S|   In the US -||
1526|049|S|   Call your doctor for medical advice about side effects. You||
1526|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1526|051|S|www.fda.gov/medwatch.||
1526|052|S|   In Canada - Call your doctor for medical advice about side||
1526|053|S|effects. You may report side effects to Health Canada at||
1526|054|S|1-866-234-2345.||
1526|055|B|||
1526|056|P|PRECAUTIONS:  Before taking crofelemer, tell your doctor or||
1526|057|P|pharmacist if you are allergic to it; or if you have any other||
1526|058|P|allergies. This product may contain inactive ingredients which||
1526|059|P|can cause allergic reactions or other problems. Talk to your||
1526|060|P|pharmacist for more details.||
1526|061|P|   Before using this medication, tell your doctor or pharmacist||
1526|062|P|your medical history.||
1526|063|P|   Before having surgery, tell your doctor or dentist about all||
1526|064|P|the products you use (including prescription drugs,||
1526|065|P|nonprescription drugs, and herbal products).||
1526|066|P|   During pregnancy, this medication should be used only when||
1526|067|P|clearly needed. Discuss the risks and benefits with your doctor.||
1526|068|P|   It is unknown if this medication passes into breast milk.||
1526|069|P|Because breast milk may transmit HIV, consult your doctor before||
1526|070|P|breastfeeding.||
1526|071|B|||
1526|072|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1526|073|I|medications work or increase your risk for serious side effects.||
1526|074|I|This document does not contain all possible drug interactions.||
1526|075|I|Keep a list of all the products you use (including||
1526|076|I|prescription/nonprescription drugs and herbal products) and share||
1526|077|I|it with your doctor and pharmacist. Do not start, stop, or change||
1526|078|I|the dosage of any medicines without your doctor's approval.||
1526|079|B|||
1526|080|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1526|081|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1526|082|O|poison control center right away. US residents can call||
1526|083|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1526|084|B|||
1526|085|N|NOTES:  Do not share this medication with others.||
1526|086|B|||
1526|087|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1526|088|D|remember. If it is near the time of the next dose, skip the||
1526|089|D|missed dose. Take your next dose at the regular time. Do not||
1526|090|D|double the dose to catch up.||
1526|091|B|||
1526|092|R|STORAGE:  Store at room temperature away from light and moisture.||
1526|093|R|Do not store in the bathroom. Keep all medications away from||
1526|094|R|children and pets.||
1526|095|R|   Do not flush medications down the toilet or pour them into a||
1526|096|R|drain unless instructed to do so. Properly discard this product||
1526|097|R|when it is expired or no longer needed. Consult your pharmacist||
1526|098|R|or local waste disposal company.||
1526|099|B|||
1526|100|A|Information last revised November 2024.||
1526|101|A|Copyright(c) 2025 First Databank, Inc.||
1526|102|B|||
1527|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1527|002|Z|does NOT have all possible information about this product. This||
1527|003|Z|information does not assure that this product is safe, effective,||
1527|004|Z|or appropriate for you. This information is not individual||
1527|005|Z|medical advice and does not substitute for the advice of your||
1527|006|Z|health care professional. Always ask your health care||
1527|007|Z|professional for complete information about this product and your||
1527|008|Z|specific health needs.||
1527|009|B|||
1527|010|T|PASIREOTIDE - SUBCUTANEOUS INJECTION||
1527|011|F|(PAS-i-REE-oh-tide)||
1527|012|B|||
1527|013|C|COMMON BRAND NAME(S): Signifor||
1527|014|B|||
1527|015|U|USES:  Pasireotide is used to treat a certain condition||
1527|016|U|(Cushing's disease) when surgery has not been fully successful or||
1527|017|U|cannot be used to correct the condition. Cushing's disease occurs||
1527|018|U|when the body makes too much of a certain hormone called||
1527|019|U|cortisol. Having too much cortisol in the body may lead to high||
1527|020|U|blood pressure, high blood sugar, and other problems. Pasireotide||
1527|021|U|works by decreasing the amount of cortisol made in the body.||
1527|022|B|||
1527|023|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1527|024|H|provided by your pharmacist before you start using pasireotide||
1527|025|H|and each time you get a refill. Ask your health care professional||
1527|026|H|how to prepare and use this medication. If you have any||
1527|027|H|questions, ask your doctor or pharmacist.||
1527|028|H|   Inject this medication under the skin as directed by your||
1527|029|H|doctor, usually twice daily. The injection is given in the thigh||
1527|030|H|or abdominal/stomach area. The dosage is based on your medical||
1527|031|H|condition and response to treatment.||
1527|032|H|   Before using, check this product for particles or||
1527|033|H|discoloration. If either is present, do not use the liquid.||
1527|034|H|Before injecting each dose, clean the skin you are going to||
1527|035|H|inject into (the injection site) with rubbing alcohol. Change the||
1527|036|H|injection site each time to lessen injury under the skin. Do not||
1527|037|H|inject into skin that is red or irritated. To lessen bruising, do||
1527|038|H|not rub the injection site after a shot. Learn how to store and||
1527|039|H|discard medical supplies safely.||
1527|040|H|   Use this medication regularly to get the most benefit from it.||
1527|041|H|To help you remember, use it at the same times each day.||
1527|042|H|   It may take up to 2 months before you get the full benefit of||
1527|043|H|this drug.||
1527|044|H|   Tell your doctor if your condition does not get better or if||
1527|045|H|it gets worse.||
1527|046|B|||
1527|047|S|SIDE EFFECTS:  Headache, hair loss, dizziness, diarrhea, gas,||
1527|048|S|bloating, constipation, muscle pain, swelling of arms/legs, and||
1527|049|S|redness/pain/swelling/itching/bleeding at injection site may||
1527|050|S|occur. If any of these effects last or get worse, tell your||
1527|051|S|doctor or pharmacist promptly.||
1527|052|S|   Remember that this medication has been prescribed because your||
1527|053|S|doctor has judged that the benefit to you is greater than the||
1527|054|S|risk of side effects. Many people using this medication do not||
1527|055|S|have serious side effects.||
1527|056|S|   This medication may cause changes in blood sugar, especially||
1527|057|S|if you have diabetes. Symptoms of high blood sugar include||
1527|058|S|increased thirst and urination. Symptoms of low blood sugar||
1527|059|S|include sudden sweating, shaking, fast heartbeat, hunger, blurred||
1527|060|S|vision, dizziness, or tingling hands/feet. Follow your doctor's||
1527|061|S|instructions to treat low blood sugar (for example, by eating a||
1527|062|S|quick source of sugar such as glucose gel/tablets, table sugar,||
1527|063|S|honey, or drinking fruit juice or non-diet soda). Tell your||
1527|064|S|doctor right away if you experience symptoms of high or low blood||
1527|065|S|sugar while using this medication. Monitor your blood sugar||
1527|066|S|levels as directed by your doctor. Your doctor may need to adjust||
1527|067|S|your diabetes medications.||
1527|068|S|   Tell your doctor right away if you have any serious side||
1527|069|S|effects, including: nausea/vomiting, weakness, unusual tiredness,||
1527|070|S|weight loss, change in stool color, extreme drowsiness,||
1527|071|S|mental/mood changes, seizures, slow heartbeat, signs of||
1527|072|S|liver/gall bladder disease (such as loss of appetite,||
1527|073|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1527|074|S|   Get medical help right away if you have any very serious side||
1527|075|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1527|076|S|fainting.||
1527|077|S|   A very serious allergic reaction to this drug is rare.||
1527|078|S|However, get medical help right away if you notice any symptoms||
1527|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1527|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1527|081|S|breathing.||
1527|082|S|   This is not a complete list of possible side effects. If you||
1527|083|S|notice other effects not listed above, contact your doctor or||
1527|084|S|pharmacist.||
1527|085|S|   In the US -||
1527|086|S|   Call your doctor for medical advice about side effects. You||
1527|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1527|088|S|www.fda.gov/medwatch.||
1527|089|S|   In Canada - Call your doctor for medical advice about side||
1527|090|S|effects. You may report side effects to Health Canada at||
1527|091|S|1-866-234-2345.||
1527|092|B|||
1527|093|P|PRECAUTIONS:  Before using pasireotide, tell your doctor or||
1527|094|P|pharmacist if you are allergic to it; or if you have any other||
1527|095|P|allergies. This product may contain inactive ingredients, which||
1527|096|P|can cause allergic reactions or other problems. Talk to your||
1527|097|P|pharmacist for more details.||
1527|098|P|   Before using this medication, tell your doctor or pharmacist||
1527|099|P|your medical history, especially of: liver disease, heart||
1527|100|P|problems (such as irregular heartbeat, heart block), diabetes,||
1527|101|P|gallbladder problems (such as gallstones).||
1527|102|P|   Pasireotide may cause a condition that affects the heart||
1527|103|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1527|104|P|serious (rarely fatal) fast/irregular heartbeat and other||
1527|105|P|symptoms (such as severe dizziness, fainting) that need medical||
1527|106|P|attention right away.||
1527|107|P|   The risk of QT prolongation may be increased if you have||
1527|108|P|certain medical conditions or are taking other drugs that may||
1527|109|P|cause QT prolongation. Before using pasireotide, tell your doctor||
1527|110|P|or pharmacist of all the drugs you take and if you have any of||
1527|111|P|the following conditions: certain heart problems (heart failure,||
1527|112|P|slow heartbeat, QT prolongation in the EKG), family history of||
1527|113|P|certain heart problems (QT prolongation in the EKG, sudden||
1527|114|P|cardiac death).||
1527|115|P|   Low levels of potassium or magnesium in the blood may also||
1527|116|P|increase your risk of QT prolongation. This risk may increase if||
1527|117|P|you use certain drugs (such as diuretics/"water pills") or if you||
1527|118|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1527|119|P|Talk to your doctor about using pasireotide safely.||
1527|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1527|121|P|can make you more dizzy. Do not drive, use machinery, or do||
1527|122|P|anything that needs alertness until you can do it safely. Limit||
1527|123|P|alcoholic beverages. Talk to your doctor if you are using||
1527|124|P|marijuana (cannabis).||
1527|125|P|   Before having surgery, tell your doctor or dentist about all||
1527|126|P|the products you use (including prescription drugs,||
1527|127|P|nonprescription drugs, and herbal products).||
1527|128|P|   Older adults may be more sensitive to the side effects of this||
1527|129|P|drug, especially QT prolongation.||
1527|130|P|   Treatment with this medication may improve fertility in women||
1527|131|P|and may lead to unintended pregnancy. Ask your doctor for more||
1527|132|P|details.||
1527|133|P|   During pregnancy, this medication should be used only when||
1527|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
1527|135|P|   It is unknown if this medication passes into breast milk.||
1527|136|P|Consult your doctor before breastfeeding.||
1527|137|B|||
1527|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1527|139|I|medications work or increase your risk for serious side effects.||
1527|140|I|This document does not contain all possible drug interactions.||
1527|141|I|Keep a list of all the products you use (including||
1527|142|I|prescription/nonprescription drugs and herbal products) and share||
1527|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
1527|144|I|the dosage of any medicines without your doctor's approval.||
1527|145|B|||
1527|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1527|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1527|148|O|poison control center right away. US residents can call||
1527|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1527|150|B|||
1527|151|N|NOTES:  Do not share this medication with others.||
1527|152|N|   Lab and/or medical tests (such as blood sugar tests,||
1527|153|N|hemoglobin A1c, liver function, hormone levels including cortisol||
1527|154|N|and thyroid, EKG, gallbladder ultrasound) should be done before||
1527|155|N|you start using this medication and while you are using it. Keep||
1527|156|N|all medical and lab appointments. Consult your doctor for more||
1527|157|N|details.||
1527|158|B|||
1527|159|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1527|160|D|If it is near the time of the next dose, skip the missed dose.||
1527|161|D|Use your next dose at the regular time. Do not double the dose to||
1527|162|D|catch up.||
1527|163|B|||
1527|164|R|STORAGE:  Store at room temperature. Keep the medication in the||
1527|165|R|original packaging to protect from light. Keep all medications||
1527|166|R|away from children and pets.||
1527|167|R|   Do not flush medications down the toilet or pour them into a||
1527|168|R|drain unless instructed to do so. Properly discard this product||
1527|169|R|when it is expired or no longer needed. Consult your pharmacist||
1527|170|R|or local waste disposal company.||
1527|171|B|||
1527|172|A|Information last revised December 2024.||
1527|173|A|Copyright(c) 2025 First Databank, Inc.||
1527|174|B|||
1528|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1528|002|Z|does NOT have all possible information about this product. This||
1528|003|Z|information does not assure that this product is safe, effective,||
1528|004|Z|or appropriate for you. This information is not individual||
1528|005|Z|medical advice and does not substitute for the advice of your||
1528|006|Z|health care professional. Always ask your health care||
1528|007|Z|professional for complete information about this product and your||
1528|008|Z|specific health needs.||
1528|009|B|||
1528|010|T|ARIPIPRAZOLE DISINTEGRATING TABLET - ORAL||
1528|011|F|(AR-i-PIP-ra-zole)||
1528|012|B|||
1528|013|C|COMMON BRAND NAME(S): Abilify Discmelt||
1528|014|B|||
1528|015|W|WARNING:  If you are using aripiprazole in combination with other||
1528|016|W|medication to treat depression, also carefully read the drug||
1528|017|W|information for the other medication.||
1528|018|W|   There may be a slightly increased risk of serious, possibly||
1528|019|W|fatal side effects (such as stroke, heart failure, fast/irregular||
1528|020|W|heartbeat, pneumonia) when this medication is used by older||
1528|021|W|adults with dementia. This medication is not approved for the||
1528|022|W|treatment of dementia-related behavior problems. Discuss the||
1528|023|W|risks and benefits of this medication, as well as other effective||
1528|024|W|and possibly safer treatments for dementia-related behavior||
1528|025|W|problems, with the doctor.||
1528|026|B|||
1528|027|U|USES:  This medication is used to treat certain mental/mood||
1528|028|U|disorders (such as bipolar disorder, schizophrenia, Tourette's||
1528|029|U|syndrome, and irritability associated with autistic disorder). It||
1528|030|U|may also be used in combination with other medication to treat||
1528|031|U|depression. Aripiprazole belongs to a class of drugs known as||
1528|032|U|atypical antipsychotics. It works by helping to restore the||
1528|033|U|balance of certain natural substances in the brain.||
1528|034|B|||
1528|035|V|OTHER USES:  This section contains uses of this drug that are not||
1528|036|V|listed in the approved professional labeling for the drug but||
1528|037|V|that may be prescribed by your health care professional. Use this||
1528|038|V|drug for a condition that is listed in this section only if it||
1528|039|V|has been so prescribed by your health care professional.||
1528|040|V|   This medication may also be used for obsessive-compulsive||
1528|041|V|disorder.||
1528|042|B|||
1528|043|H|HOW TO USE:  Read the Medication Guide provided by your||
1528|044|H|pharmacist before you start taking aripiprazole and each time you||
1528|045|H|get a refill. If you have any questions, ask your doctor or||
1528|046|H|pharmacist.||
1528|047|H|   Take this medication by mouth with or without food as directed||
1528|048|H|by your doctor, usually once daily. The dosage is based on your||
1528|049|H|medical condition, response to treatment, age, and other||
1528|050|H|medications you may be taking. Be sure to tell your doctor and||
1528|051|H|pharmacist about all the products you use (including prescription||
1528|052|H|drugs, nonprescription drugs, and herbal products). To reduce||
1528|053|H|your risk of side effects, your doctor may direct you to start||
1528|054|H|this medication at a low dose and gradually increase your dose.||
1528|055|H|Follow your doctor's instructions carefully.||
1528|056|H|   Do not remove the tablet from the blister pack until just||
1528|057|H|before taking. Dry your hands before peeling back the foil on the||
1528|058|H|blister pack to carefully remove a tablet. Do not push the tablet||
1528|059|H|through the foil. The tablet is fragile and should not be cut,||
1528|060|H|split, or broken before using. Place each dose on the tongue,||
1528|061|H|allow it to dissolve completely, then swallow it with saliva. You||
1528|062|H|do not need to take this medication with water.||
1528|063|H|   Do not increase your dose or use this drug more often or for||
1528|064|H|longer than prescribed. Your condition will not improve any||
1528|065|H|faster, and your risk of side effects will increase.||
1528|066|H|   It may take several weeks before you get the full benefit of||
1528|067|H|this drug. Use this medication regularly to get the most benefit||
1528|068|H|from it. To help you remember, take it at the same time each day.||
1528|069|H|   Keep taking this medication even if you feel well. Do not stop||
1528|070|H|taking this medication without consulting your doctor. Some||
1528|071|H|conditions may become worse when this drug is suddenly stopped.||
1528|072|H|Your dose may need to be gradually decreased.||
1528|073|H|   Tell your doctor if your condition does not get better or if||
1528|074|H|it gets worse.||
1528|075|B|||
1528|076|S|SIDE EFFECTS:  See also Warning section.||
1528|077|S|   Dizziness, lightheadedness, drowsiness, nausea, vomiting,||
1528|078|S|tiredness, excess saliva/drooling, blurred vision, weight gain,||
1528|079|S|constipation, headache, and trouble sleeping may occur. If any of||
1528|080|S|these effects last or get worse, tell your doctor or pharmacist||
1528|081|S|promptly.||
1528|082|S|   Dizziness and lightheadedness can increase the risk of||
1528|083|S|falling. Get up slowly when rising from a sitting or lying||
1528|084|S|position.||
1528|085|S|   Remember that this medication has been prescribed because your||
1528|086|S|doctor has judged that the benefit to you is greater than the||
1528|087|S|risk of side effects. Many people using this medication do not||
1528|088|S|have serious side effects.||
1528|089|S|   Tell your doctor right away if you have any serious side||
1528|090|S|effects, including: fainting, mental/mood changes (such as||
1528|091|S|increased anxiety, depression, suicidal thoughts), trouble||
1528|092|S|swallowing, restlessness (especially in the legs), shaking||
1528|093|S|(tremor), muscle spasm, mask-like expression of the face,||
1528|094|S|seizures, trouble controlling certain urges (such as gambling,||
1528|095|S|sex, eating or shopping), interrupted breathing during sleep.||
1528|096|S|   This medication may rarely make your blood sugar rise, which||
1528|097|S|can cause or worsen diabetes. Tell your doctor right away if you||
1528|098|S|have symptoms of high blood sugar such as increased||
1528|099|S|thirst/urination. If you already have diabetes, check your blood||
1528|100|S|sugar regularly as directed and share the results with your||
1528|101|S|doctor. Your doctor may need to adjust your diabetes medication,||
1528|102|S|exercise program, or diet.||
1528|103|S|   This medication may rarely cause a condition called tardive||
1528|104|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1528|105|S|your doctor right away if you develop any unusual uncontrolled||
1528|106|S|movements (especially of the face, mouth, tongue, arms, or legs).||
1528|107|S|   This medication may rarely cause a very serious condition||
1528|108|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1528|109|S|right away if you have any of the following symptoms: fever,||
1528|110|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1528|111|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1528|112|S|signs of kidney problems (such as change in the amount of urine).||
1528|113|S|   A very serious allergic reaction to this drug is rare.||
1528|114|S|However, get medical help right away if you notice any symptoms||
1528|115|S|of a serious allergic reaction, including: fever, swollen lymph||
1528|116|S|nodes, rash, itching/swelling (especially of the||
1528|117|S|face/tongue/throat), severe dizziness, trouble breathing.||
1528|118|S|   This is not a complete list of possible side effects. If you||
1528|119|S|notice other effects not listed above, contact your doctor or||
1528|120|S|pharmacist.||
1528|121|S|   In the US -||
1528|122|S|   Call your doctor for medical advice about side effects. You||
1528|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1528|124|S|www.fda.gov/medwatch.||
1528|125|S|   In Canada - Call your doctor for medical advice about side||
1528|126|S|effects. You may report side effects to Health Canada at||
1528|127|S|1-866-234-2345.||
1528|128|B|||
1528|129|P|PRECAUTIONS:  See also Warning section.||
1528|130|P|   Before taking aripiprazole, tell your doctor or pharmacist if||
1528|131|P|you are allergic to it; or if you have any other allergies. This||
1528|132|P|product may contain inactive ingredients, which can cause||
1528|133|P|allergic reactions or other problems. Talk to your pharmacist for||
1528|134|P|more details.||
1528|135|P|   Before using this medication, tell your doctor or pharmacist||
1528|136|P|your medical history, especially of: problems with blood flow in||
1528|137|P|the brain (such as cerebrovascular disease, stroke), diabetes||
1528|138|P|(including family history), heart problems (such as low blood||
1528|139|P|pressure, coronary artery disease, heart failure, irregular||
1528|140|P|heartbeat), nervous system problems (such as dementia, NMS,||
1528|141|P|seizures), obesity, low white blood cell count (including history||
1528|142|P|of low white blood cell count caused by medications), swallowing||
1528|143|P|problems, breathing trouble during sleep (sleep apnea).||
1528|144|P|   This drug may make you dizzy or drowsy or blur your vision.||
1528|145|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1528|146|P|drowsy. Do not drive, use machinery, or do anything that needs||
1528|147|P|alertness or clear vision until you can do it safely. Avoid||
1528|148|P|alcoholic beverages. Talk to your doctor if you are using||
1528|149|P|marijuana (cannabis).||
1528|150|P|   This medication may make you sweat less, making you more||
1528|151|P|likely to get heat stroke. Avoid doing things that may cause you||
1528|152|P|to overheat, such as hard work or exercise in hot weather, or||
1528|153|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1528|154|P|and dress lightly. If you overheat, quickly look for a place to||
1528|155|P|cool down and rest. Get medical help right away if you have a||
1528|156|P|fever that does not go away, mental/mood changes, headache, or||
1528|157|P|dizziness.||
1528|158|P|   This medication may contain aspartame. If you have||
1528|159|P|phenylketonuria (PKU) or any other condition that requires you to||
1528|160|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
1528|161|P|doctor or pharmacist about using this medication safely.||
1528|162|P|   Before having surgery, tell your doctor or dentist about all||
1528|163|P|the products you use (including prescription drugs,||
1528|164|P|nonprescription drugs, and herbal products).||
1528|165|P|   Older adults may be more sensitive to the side effects of this||
1528|166|P|drug, especially seizures, drowsiness, dizziness,||
1528|167|P|lightheadedness, confusion, tardive dyskinesia, swallowing||
1528|168|P|problems, and other serious (rarely fatal) side effects. (See||
1528|169|P|also Warning section.) Drowsiness, dizziness, lightheadedness,||
1528|170|P|and confusion can increase the risk of falling.||
1528|171|P|   During pregnancy, this medication should be used only when||
1528|172|P|clearly needed. Babies born to mothers who have used this drug||
1528|173|P|during the last 3 months of pregnancy may rarely develop symptoms||
1528|174|P|including muscle stiffness or shakiness, drowsiness,||
1528|175|P|feeding/breathing difficulties, or constant crying. If you notice||
1528|176|P|any of these symptoms in your newborn especially during their||
1528|177|P|first month, tell the doctor right away.||
1528|178|P|   Since untreated mental/mood problems (such as bipolar||
1528|179|P|disorder, schizophrenia) can be a serious condition, do not stop||
1528|180|P|taking this medication unless directed by your doctor. If you are||
1528|181|P|planning pregnancy, become pregnant, or think you may be||
1528|182|P|pregnant, immediately discuss with your doctor the benefits and||
1528|183|P|risks of using this medication during pregnancy.||
1528|184|P|   This medication passes into breast milk. Consult your doctor||
1528|185|P|before breastfeeding.||
1528|186|B|||
1528|187|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1528|188|I|medications work or increase your risk for serious side effects.||
1528|189|I|This document does not contain all possible drug interactions.||
1528|190|I|Keep a list of all the products you use (including||
1528|191|I|prescription/nonprescription drugs and herbal products) and share||
1528|192|I|it with your doctor and pharmacist. Do not start, stop, or change||
1528|193|I|the dosage of any medicines without your doctor's approval.||
1528|194|I|   A product that may interact with this drug is: metoclopramide.||
1528|195|I|   Tell your doctor or pharmacist if you are taking other||
1528|196|I|products that cause drowsiness such as opioid pain or cough||
1528|197|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1528|198|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1528|199|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1528|200|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1528|201|I|diphenhydramine).||
1528|202|I|   Check the labels on all your medicines (such as allergy or||
1528|203|I|cough-and-cold products) because they may contain ingredients||
1528|204|I|that cause drowsiness. Ask your pharmacist about using those||
1528|205|I|products safely.||
1528|206|B|||
1528|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1528|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1528|209|O|poison control center right away. US residents can call||
1528|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1528|211|O|Symptoms of overdose may include: very fast heartbeat, loss of||
1528|212|O|consciousness.||
1528|213|B|||
1528|214|N|NOTES:  Do not share this medication with others.||
1528|215|N|   Lab and/or medical tests (such as blood sugar, weight,||
1528|216|N|cholesterol/triglyceride levels) may be done before you start||
1528|217|N|taking this medication and while you are taking it. Keep all||
1528|218|N|medical and lab appointments. Consult your doctor for more||
1528|219|N|details.||
1528|220|B|||
1528|221|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1528|222|D|remember. If it is near the time of the next dose, skip the||
1528|223|D|missed dose. Take your next dose at the regular time. Do not||
1528|224|D|double the dose to catch up.||
1528|225|B|||
1528|226|R|STORAGE:  Store at room temperature away from light and moisture.||
1528|227|R|Do not store in the bathroom. Keep all medications away from||
1528|228|R|children and pets.||
1528|229|R|   Do not flush medications down the toilet or pour them into a||
1528|230|R|drain unless instructed to do so. Properly discard this product||
1528|231|R|when it is expired or no longer needed. Consult your pharmacist||
1528|232|R|or local waste disposal company.||
1528|233|B|||
1528|234|A|Information last revised October 2024.||
1528|235|A|Copyright(c) 2025 First Databank, Inc.||
1528|236|B|||
1529|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1529|002|Z|does NOT have all possible information about this product. This||
1529|003|Z|information does not assure that this product is safe, effective,||
1529|004|Z|or appropriate for you. This information is not individual||
1529|005|Z|medical advice and does not substitute for the advice of your||
1529|006|Z|health care professional. Always ask your health care||
1529|007|Z|professional for complete information about this product and your||
1529|008|Z|specific health needs.||
1529|009|B|||
1529|010|T|CANAGLIFLOZIN - ORAL||
1529|011|F|(KAN-a-gli-FLOE-zin)||
1529|012|B|||
1529|013|C|COMMON BRAND NAME(S): Invokana||
1529|014|B|||
1529|015|U|USES:  Canagliflozin is used with a proper diet and exercise||
1529|016|U|program to control high blood sugar in people with type 2||
1529|017|U|diabetes. Controlling high blood sugar helps prevent kidney||
1529|018|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1529|019|U|function problems. Canagliflozin is also used by people with type||
1529|020|U|2 diabetes and heart disease to lower the risk of death from||
1529|021|U|heart attack or stroke. Canagliflozin is also used by people with||
1529|022|U|type 2 diabetes and kidney disease to lower the risk of dialysis,||
1529|023|U|death from heart disease, and the need to go to the hospital for||
1529|024|U|heart failure. Canagliflozin works by increasing the removal of||
1529|025|U|sugar by your kidneys.||
1529|026|B|||
1529|027|H|HOW TO USE:  Read the Medication Guide provided by your||
1529|028|H|pharmacist before you start taking canagliflozin and each time||
1529|029|H|you get a refill. If you have any questions, ask your doctor or||
1529|030|H|pharmacist.||
1529|031|H|   Take this medication by mouth as directed by your doctor,||
1529|032|H|usually once daily before the first meal of the day. The dosage||
1529|033|H|is based on your medical condition, response to treatment, and||
1529|034|H|other medications you may be taking. Be sure to tell your doctor||
1529|035|H|and pharmacist about all the products you use (including||
1529|036|H|prescription drugs, nonprescription drugs, and herbal products).||
1529|037|H|   Take this medication regularly to get the most benefit from||
1529|038|H|it. To help you remember, take it at the same time each day.||
1529|039|H|   Tell your doctor if your condition does not get better or if||
1529|040|H|it gets worse (your blood sugar is too high or too low).||
1529|041|B|||
1529|042|S|SIDE EFFECTS:  Frequent urination, unusual dry mouth, dizziness,||
1529|043|S|and lightheadedness may occur. If any of these effects last or||
1529|044|S|get worse, tell your doctor or pharmacist promptly.||
1529|045|S|   To reduce the risk of dizziness and lightheadedness, get up||
1529|046|S|slowly when rising from a sitting or lying position.||
1529|047|S|   Remember that this medication has been prescribed because your||
1529|048|S|doctor has judged that the benefit to you is greater than the||
1529|049|S|risk of side effects. Many people using this medication do not||
1529|050|S|have serious side effects.||
1529|051|S|   Tell your doctor right away if you have any serious side||
1529|052|S|effects, including: signs of bladder infection (such as fever,||
1529|053|S|urgent urination, burning/pain when you urinate), signs of kidney||
1529|054|S|problems (such as change in the amount of urine, swelling||
1529|055|S|legs/feet), signs of high level of potassium in the blood (such||
1529|056|S|as muscle weakness and slow/irregular heartbeat).||
1529|057|S|   Get medical help right away if you have any very serious side||
1529|058|S|effects, including: unusual tiredness, nausea/vomiting,||
1529|059|S|stomach/abdominal pain, trouble breathing.||
1529|060|S|   This medication may cause a new yeast infection in the vagina||
1529|061|S|or the penis. It may also cause a rare but very serious bacterial||
1529|062|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1529|063|S|your doctor right away if you have signs of a yeast infection in||
1529|064|S|the vagina (such as unusual vaginal||
1529|065|S|discharge/burning/itching/odor) or in the penis (such as||
1529|066|S|redness/itching/swelling of the penis, unusual discharge from the||
1529|067|S|penis). However, get medical help right away if you have any||
1529|068|S|pain/redness/swelling in or around the genital/anal area, along||
1529|069|S|with a fever or feeling unwell.||
1529|070|S|   Canagliflozin does not usually cause low blood sugar||
1529|071|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1529|072|S|prescribed with other diabetes medications, or if you do not get||
1529|073|S|enough calories from food, or if you do unusually heavy exercise.||
1529|074|S|Talk with your doctor or pharmacist about whether the dose of||
1529|075|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1529|076|S|of low blood sugar include sudden sweating, shaking, fast||
1529|077|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1529|078|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1529|079|S|treat low blood sugar. If you don't have these reliable forms of||
1529|080|S|glucose, rapidly raise your blood sugar by eating a quick source||
1529|081|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1529|082|S|juice or non-diet soda. Tell your doctor right away about the||
1529|083|S|reaction and the use of this product. To help prevent low blood||
1529|084|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1529|085|S|Check with your doctor or pharmacist to find out what you should||
1529|086|S|do if you miss a meal.||
1529|087|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1529|088|S|thirst/urination. If these symptoms occur, tell your doctor right||
1529|089|S|away. Your doctor may need to adjust your diabetes medication,||
1529|090|S|exercise program, or diet.||
1529|091|S|   Canagliflozin may rarely increase the risk of losing a lower||
1529|092|S|limb. This risk may be greater in people who have a history of||
1529|093|S|heart disease, blood circulation disease (peripheral vascular||
1529|094|S|disease), nerve problems (neuropathy), foot ulcers, or previous||
1529|095|S|loss of limbs. Talk to your doctor for more details. Tell your||
1529|096|S|doctor right away if you have any||
1529|097|S|pain/tenderness/redness/swelling/sores on your legs and feet.||
1529|098|S|   This medication may cause you to become dehydrated. This can||
1529|099|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1529|100|S|dehydration. Tell your doctor or pharmacist right away if you are||
1529|101|S|not able to drink fluids as usual, or losing fluid (such as due||
1529|102|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1529|103|S|right away if you have any signs of dehydration, such as||
1529|104|S|urinating less than usual, unusual dry mouth/thirst, fast||
1529|105|S|heartbeat, or dizziness/lightheadedness/fainting.||
1529|106|S|   Canagliflozin may cause some bone loss, or even a broken bone.||
1529|107|S|Lifestyle habits that help promote healthy bones include||
1529|108|S|weight-bearing exercises, stopping smoking, limiting alcohol, and||
1529|109|S|eating well-balanced meals that contain adequate calcium and||
1529|110|S|vitamin D. You may also need to take calcium and vitamin D||
1529|111|S|supplements. Talk to your doctor for specific advice.||
1529|112|S|   A very serious allergic reaction to this drug is rare.||
1529|113|S|However, get medical help right away if you notice any symptoms||
1529|114|S|of a serious allergic reaction, including: rash, itching/swelling||
1529|115|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1529|116|S|breathing.||
1529|117|S|   This is not a complete list of possible side effects. If you||
1529|118|S|notice other effects not listed above, contact your doctor or||
1529|119|S|pharmacist.||
1529|120|S|   In the US -||
1529|121|S|   Call your doctor for medical advice about side effects. You||
1529|122|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1529|123|S|www.fda.gov/medwatch.||
1529|124|S|   In Canada - Call your doctor for medical advice about side||
1529|125|S|effects. You may report side effects to Health Canada at||
1529|126|S|1-866-234-2345.||
1529|127|B|||
1529|128|P|PRECAUTIONS:  See also Side Effects section.||
1529|129|P|   Before taking canagliflozin, tell your doctor or pharmacist if||
1529|130|P|you are allergic to it; or if you have any other allergies. This||
1529|131|P|product may contain inactive ingredients which can cause allergic||
1529|132|P|reactions or other problems. Talk to your pharmacist for more||
1529|133|P|details.||
1529|134|P|   Before using this medication, tell your doctor or pharmacist||
1529|135|P|your medical history, especially of: kidney disease, disease of||
1529|136|P|the pancreas (pancreatitis), dehydration, use/abuse of alcohol,||
1529|137|P|low blood pressure, heart failure, mineral imbalances (such as||
1529|138|P|high levels of potassium), history of yeast infections in the||
1529|139|P|vagina or penis.||
1529|140|P|   You may experience blurred vision, dizziness, or drowsiness||
1529|141|P|due to extremely low or high blood sugar. Do not drive, use||
1529|142|P|machinery, or do anything that needs alertness or clear vision||
1529|143|P|until you can do it safely.||
1529|144|P|   Limit alcohol while taking this medication because it can||
1529|145|P|increase your risk of developing low blood sugar and a high||
1529|146|P|ketone level.||
1529|147|P|   It may be harder to control your blood sugar when your body is||
1529|148|P|stressed (such as due to fever, infection, injury, or surgery).||
1529|149|P|Also, if you are eating less or not able to eat due to these||
1529|150|P|conditions or any illness, this can lead to a high ketone level||
1529|151|P|while you are taking this medication. Consult your doctor because||
1529|152|P|this may require a change in your treatment plan, medications, or||
1529|153|P|blood sugar or ketone testing.||
1529|154|P|   Before having surgery, tell your doctor or dentist about all||
1529|155|P|the products you use (including prescription drugs,||
1529|156|P|nonprescription drugs, and herbal products).||
1529|157|P|   Older adults may be more sensitive to the side effects of this||
1529|158|P|drug, especially dizziness/fainting (usually when standing),||
1529|159|P|dehydration, or some bone loss.||
1529|160|P|   During pregnancy, this medication should be used only when||
1529|161|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1529|162|P|benefits with your doctor.||
1529|163|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1529|164|P|your doctor for managing your blood sugar while pregnant. Your||
1529|165|P|doctor may change your diabetes treatment during your pregnancy||
1529|166|P|(such as diet and medications including insulin).||
1529|167|P|   It is unknown if this drug passes into breast milk. Consult||
1529|168|P|your doctor before breastfeeding.||
1529|169|B|||
1529|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1529|171|I|medications work or increase your risk for serious side effects.||
1529|172|I|This document does not contain all possible drug interactions.||
1529|173|I|Keep a list of all the products you use (including||
1529|174|I|prescription/nonprescription drugs and herbal products) and share||
1529|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
1529|176|I|the dosage of any medicines without your doctor's approval.||
1529|177|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1529|178|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1529|179|I|heartbeat you would usually feel when your blood sugar falls too||
1529|180|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1529|181|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1529|182|I|   Many drugs can affect your blood sugar, making it harder to||
1529|183|I|control. Before you start, stop, or change any medication, talk||
1529|184|I|with your doctor or pharmacist about how the medication may||
1529|185|I|affect your blood sugar. Check your blood sugar regularly as||
1529|186|I|directed and share the results with your doctor. Tell your doctor||
1529|187|I|right away if you have symptoms of high or low blood sugar. (See||
1529|188|I|also Side Effects section.) Your doctor may need to adjust your||
1529|189|I|diabetes medication, exercise program, or diet.||
1529|190|I|   This medication may interfere with certain lab tests (such as||
1529|191|I|urine glucose test), possibly causing false test results. Make||
1529|192|I|sure lab personnel and all your doctors know you use this drug.||
1529|193|B|||
1529|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1529|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1529|196|O|poison control center right away. US residents can call||
1529|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1529|198|B|||
1529|199|N|NOTES:  Do not share this medication with others.||
1529|200|N|   Attend a diabetes education program to learn more about how to||
1529|201|N|manage your diabetes with medications, diet, exercise, and||
1529|202|N|regular medical exams.||
1529|203|N|   Learn the symptoms of high and low blood sugar and how to||
1529|204|N|treat low blood sugar. Check your blood sugar regularly as||
1529|205|N|directed.||
1529|206|N|   Lab and/or medical tests (such as blood pressure, mineral||
1529|207|N|levels including potassium, cholesterol tests, kidney function,||
1529|208|N|fasting blood glucose, hemoglobin A1c, ketones, bone density) may||
1529|209|N|be done before you start taking this medication and while you are||
1529|210|N|taking it. Keep all medical and lab appointments. Consult your||
1529|211|N|doctor for more details.||
1529|212|B|||
1529|213|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1529|214|D|remember. If it is near the time of the next dose, skip the||
1529|215|D|missed dose. Take your next dose at the regular time. Do not||
1529|216|D|double the dose to catch up.||
1529|217|B|||
1529|218|R|STORAGE:  Store at room temperature away from light and moisture.||
1529|219|R|Do not store in the bathroom. Keep all medications away from||
1529|220|R|children and pets.||
1529|221|R|   Do not flush medications down the toilet or pour them into a||
1529|222|R|drain unless instructed to do so. Properly discard this product||
1529|223|R|when it is expired or no longer needed. Consult your pharmacist||
1529|224|R|or local waste disposal company.||
1529|225|B|||
1529|226|M|MEDICAL ALERT:  Your condition can cause complications in a||
1529|227|M|medical emergency. For information about enrolling in MedicAlert,||
1529|228|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1529|229|B|||
1529|230|A|Information last revised May 2025.||
1529|231|A|Copyright(c) 2025 First Databank, Inc.||
1529|232|B|||
1530|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1530|002|Z|does NOT have all possible information about this product. This||
1530|003|Z|information does not assure that this product is safe, effective,||
1530|004|Z|or appropriate for you. This information is not individual||
1530|005|Z|medical advice and does not substitute for the advice of your||
1530|006|Z|health care professional. Always ask your health care||
1530|007|Z|professional for complete information about this product and your||
1530|008|Z|specific health needs.||
1530|009|B|||
1530|010|T|DIMETHYL FUMARATE DELAYED-RELEASE CAPSULE - ORAL||
1530|011|F|(dye-METH-il FUE-ma-rate)||
1530|012|B|||
1530|013|C|COMMON BRAND NAME(S): Tecfidera||
1530|014|B|||
1530|015|U|USES:  Dimethyl fumarate is used to treat multiple sclerosis||
1530|016|U|(MS). It is not a cure for MS. It helps decrease the number of||
1530|017|U|episodes of worsening MS.||
1530|018|B|||
1530|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1530|020|H|from your pharmacist before you start taking dimethyl fumarate||
1530|021|H|and each time you get a refill. If you have any questions, ask||
1530|022|H|your doctor or pharmacist.||
1530|023|H|   Take this medication by mouth with or without food as directed||
1530|024|H|by your doctor, usually twice daily. Your doctor should usually||
1530|025|H|direct you to start this medication at a low dose for the first 7||
1530|026|H|days of treatment and to increase your dose after 7 days. Follow||
1530|027|H|your doctor's instructions carefully. If flushing occurs, taking||
1530|028|H|this medication with food may reduce this side effect. Taking a||
1530|029|H|plain (non-enteric coated) aspirin 30 minutes before taking this||
1530|030|H|medication may also help prevent flushing. Ask your doctor if||
1530|031|H|this treatment is right for you.||
1530|032|H|   Swallow the capsules whole. Do not open, crush, or chew the||
1530|033|H|capsules. Doing so can release all of the drug at once,||
1530|034|H|increasing the risk of side effects.||
1530|035|H|   Take this medication regularly to get the most benefit from||
1530|036|H|it. To help you remember, take it at the same times each day.||
1530|037|H|   Tell your doctor if your condition gets worse.||
1530|038|B|||
1530|039|S|SIDE EFFECTS:  Flushing/warmth, redness, itching, and burning||
1530|040|S|feeling of the skin may occur. Taking this drug with food may||
1530|041|S|reduce flushing. Stomach/abdominal pain, diarrhea, nausea, and||
1530|042|S|vomiting may also occur. These effects usually improve or go away||
1530|043|S|as your body adjusts to the medication. If any of these effects||
1530|044|S|last or get worse, tell your doctor or pharmacist promptly.||
1530|045|S|   Remember that this medication has been prescribed because your||
1530|046|S|doctor has judged that the benefit to you is greater than the||
1530|047|S|risk of side effects. Many people using this medication do not||
1530|048|S|have serious side effects.||
1530|049|S|   This medication may lower your ability to fight infections.||
1530|050|S|This may make you more likely to get a serious (rarely fatal)||
1530|051|S|infection or make any infection you have worse. Tell your doctor||
1530|052|S|right away if you have any signs of infection (such as sore||
1530|053|S|throat that doesn't go away, fever, chills, blisters).||
1530|054|S|   Tell your doctor right away if you have any serious side||
1530|055|S|effects, including: symptoms of liver damage (such as||
1530|056|S|nausea/vomiting that doesn't stop, loss of appetite,||
1530|057|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1530|058|S|black/bloody stools, vomit that contains blood or looks like||
1530|059|S|coffee grounds, coughing up blood.||
1530|060|S|   This medication may increase your risk of getting a rare but||
1530|061|S|very serious (sometimes fatal) brain infection (progressive||
1530|062|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1530|063|S|if any of these rare but very serious side effects occur:||
1530|064|S|clumsiness, loss of coordination, weakness, sudden change in your||
1530|065|S|thinking (such as confusion, difficulty concentrating),||
1530|066|S|difficulty moving your muscles, problems with speech, seizure,||
1530|067|S|vision changes.||
1530|068|S|   A very serious allergic reaction to this drug is rare.||
1530|069|S|However, get medical help right away if you notice any symptoms||
1530|070|S|of a serious allergic reaction, including: rash, itching/swelling||
1530|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1530|072|S|breathing.||
1530|073|S|   This is not a complete list of possible side effects. If you||
1530|074|S|notice other effects not listed above, contact your doctor or||
1530|075|S|pharmacist.||
1530|076|S|   In the US -||
1530|077|S|   Call your doctor for medical advice about side effects. You||
1530|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1530|079|S|www.fda.gov/medwatch.||
1530|080|S|   In Canada - Call your doctor for medical advice about side||
1530|081|S|effects. You may report side effects to Health Canada at||
1530|082|S|1-866-234-2345.||
1530|083|B|||
1530|084|P|PRECAUTIONS:  Before taking dimethyl fumarate, tell your doctor||
1530|085|P|or pharmacist if you are allergic to it; or to diroximel||
1530|086|P|fumarate; or to monomethyl fumarate; or if you have any other||
1530|087|P|allergies. This product may contain inactive ingredients which||
1530|088|P|can cause allergic reactions or other problems. Talk to your||
1530|089|P|pharmacist for more details.||
1530|090|P|   Before using this medication, tell your doctor or pharmacist||
1530|091|P|your medical history, especially of: low white blood cell counts,||
1530|092|P|infections (including any current infection), liver disease.||
1530|093|P|   Dimethyl fumarate can make you more likely to get infections||
1530|094|P|or may make current infections worse. Stay away from anyone who||
1530|095|P|has an infection that may easily spread (such as chickenpox,||
1530|096|P|COVID-19, measles, flu). Talk to your doctor if you have been||
1530|097|P|exposed to an infection or for more details.||
1530|098|P|   Tell your health care professional that you are using dimethyl||
1530|099|P|fumarate before having any immunizations/vaccinations. Avoid||
1530|100|P|contact with people who have recently received live vaccines||
1530|101|P|(such as flu vaccine inhaled through the nose).||
1530|102|P|   Before having surgery, tell your doctor or dentist about all||
1530|103|P|the products you use (including prescription drugs,||
1530|104|P|nonprescription drugs, and herbal products).||
1530|105|P|   During pregnancy, this medication should be used only when||
1530|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
1530|107|P|   It is unknown if this medication passes into breast milk.||
1530|108|P|Consult your doctor before breastfeeding.||
1530|109|B|||
1530|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1530|111|I|medications work or increase your risk for serious side effects.||
1530|112|I|This document does not contain all possible drug interactions.||
1530|113|I|Keep a list of all the products you use (including||
1530|114|I|prescription/nonprescription drugs and herbal products) and share||
1530|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
1530|116|I|the dosage of any medicines without your doctor's approval.||
1530|117|I|   Some products that may interact with this drug include: other||
1530|118|I|drugs that weaken the immune system/increase the risk of||
1530|119|I|infection (such as natalizumab, rituximab).||
1530|120|I|   Dimethyl fumarate is very similar to diroximel fumarate and||
1530|121|I|monomethyl fumarate. Do not use medications containing diroximel||
1530|122|I|fumarate or monomethyl fumarate while using dimethyl fumarate.||
1530|123|B|||
1530|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1530|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1530|126|O|poison control center right away. US residents can call||
1530|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1530|128|B|||
1530|129|N|NOTES:  Do not share this medication with others.||
1530|130|N|   Lab tests (such as complete blood counts, liver function)||
1530|131|N|should be done before you start taking this medication and while||
1530|132|N|you are taking it. Keep all medical and lab appointments.||
1530|133|B|||
1530|134|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1530|135|D|remember. If it is near the time of the next dose, skip the||
1530|136|D|missed dose. Take your next dose at the regular time. Do not||
1530|137|D|double the dose to catch up.||
1530|138|B|||
1530|139|R|STORAGE:  Store in the original container at room temperature||
1530|140|R|away from light and moisture. Do not store in the bathroom. Keep||
1530|141|R|all medications away from children and pets.||
1530|142|R|   Do not flush medications down the toilet or pour them into a||
1530|143|R|drain unless instructed to do so. Properly discard this product||
1530|144|R|when it is expired or no longer needed. Consult your pharmacist||
1530|145|R|or local waste disposal company.||
1530|146|B|||
1530|147|M|MEDICAL ALERT:  Your condition can cause complications in a||
1530|148|M|medical emergency. For information about enrolling in MedicAlert,||
1530|149|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1530|150|B|||
1530|151|A|Information last revised July 2025.||
1530|152|A|Copyright(c) 2025 First Databank, Inc.||
1530|153|B|||
1532|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1532|002|Z|does NOT have all possible information about this product. This||
1532|003|Z|information does not assure that this product is safe, effective,||
1532|004|Z|or appropriate for you. This information is not individual||
1532|005|Z|medical advice and does not substitute for the advice of your||
1532|006|Z|health care professional. Always ask your health care||
1532|007|Z|professional for complete information about this product and your||
1532|008|Z|specific health needs.||
1532|009|B|||
1532|010|T|OSPEMIFENE - ORAL||
1532|011|F|(os-PEM-i-feen)||
1532|012|B|||
1532|013|C|COMMON BRAND NAME(S): Osphena||
1532|014|B|||
1532|015|W|WARNING:  Ospemifene may increase your risk of uterine cancer.||
1532|016|W|Tell your doctor right away if you develop changes in menstrual||
1532|017|W|period, unusual vaginal bleeding/discharge, or pain/pressure||
1532|018|W|below your "belly button" (navel).||
1532|019|W|   Ospemifene may rarely cause serious blood clots to form in the||
1532|020|W|legs or lungs. Tell your doctor if you have a history of blood||
1532|021|W|clots (such as deep vein thrombosis, pulmonary embolism). Also||
1532|022|W|talk to your doctor about risk factors for developing strokes||
1532|023|W|(sometimes fatal) while taking this medication. Some risk factors||
1532|024|W|include tobacco use, alcohol use, having high||
1532|025|W|cholesterol/diabetes, or a history of heart disease. Talk to your||
1532|026|W|doctor about these risks and the benefits of using ospemifene.||
1532|027|B|||
1532|028|U|USES:  This medication is used to treat painful sexual||
1532|029|U|intercourse and vaginal dryness in women after menopause. Painful||
1532|030|U|intercourse and vaginal dryness are symptoms of changes in and||
1532|031|U|around your vagina, due to menopause.||
1532|032|U|   This drug is different from hormones (including estrogens and||
1532|033|U|progestins). It works by acting like estrogen in some parts of||
1532|034|U|the body. Ospemifene belongs to a class of drugs known as||
1532|035|U|selective estrogen receptor modulators (SERM).||
1532|036|B|||
1532|037|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1532|038|H|from your pharmacist before you start taking ospemifene and each||
1532|039|H|time you get a refill. If you have any questions, ask your doctor||
1532|040|H|or pharmacist.||
1532|041|H|   Take this medication by mouth with food as directed by your||
1532|042|H|doctor, usually once daily.||
1532|043|H|   Use this medication regularly to get the most benefit from it.||
1532|044|H|To help you remember, take it at the same time each day.||
1532|045|H|   Since this drug can be absorbed through the skin and lungs and||
1532|046|H|may harm an unborn baby, women who are pregnant or who may become||
1532|047|H|pregnant should not handle this medication or breathe the dust||
1532|048|H|from the tablets.||
1532|049|H|   Tell your doctor if your condition does not get better or if||
1532|050|H|it gets worse.||
1532|051|B|||
1532|052|S|SIDE EFFECTS:  See also Warning section.||
1532|053|S|   Hot flashes, vaginal discharge, muscle spasms, and sweating||
1532|054|S|may occur. If any of these effects last or get worse, tell your||
1532|055|S|doctor or pharmacist promptly.||
1532|056|S|   Remember that this medication has been prescribed because your||
1532|057|S|doctor has judged that the benefit to you is greater than the||
1532|058|S|risk of side effects. Many people using this medication do not||
1532|059|S|have serious side effects.||
1532|060|S|   This medication may rarely cause serious problems from blood||
1532|061|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1532|062|S|legs). You may be at increased risk for blood clots if you are||
1532|063|S|severely dehydrated, or have a history of blood clots,||
1532|064|S|heart/blood vessel disease, heart failure, stroke, or if you are||
1532|065|S|immobile (such as on very long plane flights or being bedridden).||
1532|066|S|Before using this medication, if you have any of these conditions||
1532|067|S|report them to your doctor or pharmacist. Get medical help right||
1532|068|S|away if any of these side effects occur: shortness of||
1532|069|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
1532|070|S|sweating, confusion, sudden dizziness/fainting,||
1532|071|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1532|072|S|trouble speaking, weakness on one side of the body, sudden vision||
1532|073|S|changes.||
1532|074|S|   A very serious allergic reaction to this drug is rare.||
1532|075|S|However, get medical help right away if you notice any symptoms||
1532|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1532|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1532|078|S|breathing.||
1532|079|S|   This is not a complete list of possible side effects. If you||
1532|080|S|notice other effects not listed above, contact your doctor or||
1532|081|S|pharmacist.||
1532|082|S|   In the US -||
1532|083|S|   Call your doctor for medical advice about side effects. You||
1532|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1532|085|S|www.fda.gov/medwatch.||
1532|086|S|   In Canada - Call your doctor for medical advice about side||
1532|087|S|effects. You may report side effects to Health Canada at||
1532|088|S|1-866-234-2345.||
1532|089|B|||
1532|090|P|PRECAUTIONS:  See also Warning and Side Effects sections.||
1532|091|P|   Before taking ospemifene, tell your doctor or pharmacist if||
1532|092|P|you are allergic to it; or if you have any other allergies. This||
1532|093|P|product may contain inactive ingredients, which can cause||
1532|094|P|allergic reactions or other problems. Talk to your pharmacist for||
1532|095|P|more details.||
1532|096|P|   Before using this medication, tell your doctor or pharmacist||
1532|097|P|your medical history, especially of: unusual vaginal bleeding,||
1532|098|P|active or past history of blood clots (such as deep venous||
1532|099|P|thrombosis, pulmonary embolism), active or past history of||
1532|100|P|heart/blood vessel disease (such as heart attack, stroke),||
1532|101|P|cancer, liver disease.||
1532|102|P|   Tell your doctor if you just had or will be having surgery or||
1532|103|P|if you will be confined to a bed or chair for a long time (such||
1532|104|P|as a long plane flight). These conditions increase your risk of||
1532|105|P|getting blood clots. You may need to stop this medication for a||
1532|106|P|time or take special precautions.||
1532|107|P|   Before having surgery, tell your doctor or dentist about all||
1532|108|P|the products you use (including prescription drugs,||
1532|109|P|nonprescription drugs, and herbal products).||
1532|110|P|   This medication must not be used during pregnancy. It may harm||
1532|111|P|an unborn baby. If you become pregnant or think you may be||
1532|112|P|pregnant, tell your doctor right away.||
1532|113|P|   Since this drug can be absorbed through the skin and lungs and||
1532|114|P|may harm an unborn baby, women who are pregnant or who may become||
1532|115|P|pregnant should not handle this medication or breathe the dust||
1532|116|P|from the tablets.||
1532|117|P|   It is unknown if this medication passes into breast milk.||
1532|118|P|Consult your doctor before breastfeeding.||
1532|119|B|||
1532|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1532|121|I|medications work or increase your risk for serious side effects.||
1532|122|I|This document does not contain all possible drug interactions.||
1532|123|I|Keep a list of all the products you use (including||
1532|124|I|prescription/nonprescription drugs and herbal products) and share||
1532|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1532|126|I|the dosage of any medicines without your doctor's approval.||
1532|127|I|   Some products that may interact with this drug include:||
1532|128|I|estrogens, tibolone.||
1532|129|I|   Other medications can affect the removal of ospemifene from||
1532|130|I|your body, which may affect how ospemifene works. Examples||
1532|131|I|include fluconazole, rifampin, among others.||
1532|132|B|||
1532|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1532|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1532|135|O|poison control center right away. US residents can call||
1532|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1532|137|B|||
1532|138|N|NOTES:  Do not share this medication with others.||
1532|139|N|   You should have a complete physical examination, breast and||
1532|140|N|pelvic examination, and PAP test (for vaginal cancer) as directed||
1532|141|N|by your doctor, usually at least once a year. You should also||
1532|142|N|have periodic mammograms as determined by your doctor. Follow||
1532|143|N|your doctor's instructions for examining your own breasts. Report||
1532|144|N|any unusual vaginal bleeding, breast pain, or lumps right away.||
1532|145|N|Keep all medical and lab appointments. Consult your doctor for||
1532|146|N|more details.||
1532|147|B|||
1532|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1532|149|D|remember. If it is near the time of the next dose, skip the||
1532|150|D|missed dose. Take your next dose at the regular time. Do not||
1532|151|D|double the dose to catch up.||
1532|152|B|||
1532|153|R|STORAGE:  Store at room temperature away from light and moisture.||
1532|154|R|Do not store in the bathroom. Keep all medications away from||
1532|155|R|children and pets.||
1532|156|R|   Do not flush medications down the toilet or pour them into a||
1532|157|R|drain unless instructed to do so. Properly discard this product||
1532|158|R|when it is expired or no longer needed. Consult your pharmacist||
1532|159|R|or local waste disposal company.||
1532|160|B|||
1532|161|A|Information last revised October 2024.||
1532|162|A|Copyright(c) 2025 First Databank, Inc.||
1532|163|B|||
1533|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1533|002|Z|does NOT have all possible information about this product. This||
1533|003|Z|information does not assure that this product is safe, effective,||
1533|004|Z|or appropriate for you. This information is not individual||
1533|005|Z|medical advice and does not substitute for the advice of your||
1533|006|Z|health care professional. Always ask your health care||
1533|007|Z|professional for complete information about this product and your||
1533|008|Z|specific health needs.||
1533|009|B|||
1533|010|T|DESOXIMETASONE SPRAY - TOPICAL||
1533|011|F|(des-OX-i-MET-a-sone)||
1533|012|B|||
1533|013|C|COMMON BRAND NAME(S): Topicort||
1533|014|B|||
1533|015|U|USES:  Desoximetasone is used to treat a type of skin condition||
1533|016|U|(plaque psoriasis). It reduces the swelling, itching, and redness||
1533|017|U|that may occur with plaque psoriasis. This medication is a strong||
1533|018|U|corticosteroid.||
1533|019|U|   This medication is not recommended for use in children younger||
1533|020|U|than 18 due to increased risk of side effects.||
1533|021|B|||
1533|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1533|023|H|from your pharmacist before you start using desoximetasone and||
1533|024|H|each time you get a refill. If you have any questions, ask your||
1533|025|H|doctor or pharmacist.||
1533|026|H|   This medication is for use on the skin only. Do not use it on||
1533|027|H|the face, groin, or underarms unless directed to do so by your||
1533|028|H|doctor. Avoid getting this medication in the eyes, mouth, or||
1533|029|H|vagina. If this occurs, rinse with plenty of water. Do not use it||
1533|030|H|on thinning skin.||
1533|031|H|   Wash and dry your hands before applying the medication, then||
1533|032|H|clean and dry the affected area. Spray only enough medication to||
1533|033|H|cover the affected areas with a thin layer and gently rub in as||
1533|034|H|directed by your doctor, usually twice daily. Do not cover,||
1533|035|H|bandage, or wrap the area unless directed to do so by your||
1533|036|H|doctor. After applying the medication, wash your hands unless you||
1533|037|H|are using this medication to treat the hands.||
1533|038|H|   This medication is flammable until dry. Avoid smoking or being||
1533|039|H|near open flames while using the medication and until the||
1533|040|H|medication has dried.||
1533|041|H|   Use this medication only for the condition prescribed. Once||
1533|042|H|your skin condition is under control, you should stop using||
1533|043|H|desoximetasone unless directed by your doctor. Do not use it for||
1533|044|H|longer than prescribed.||
1533|045|H|   Tell your doctor if your condition does not get better or if||
1533|046|H|it gets worse after 4 weeks. According to the manufacturer, you||
1533|047|H|should not use this drug for longer than 4 weeks.||
1533|048|B|||
1533|049|S|SIDE EFFECTS:  Skin irritation, dryness, or itching may occur. If||
1533|050|S|any of these effects last or get worse, tell your doctor or||
1533|051|S|pharmacist promptly.||
1533|052|S|   Remember that this medication has been prescribed because your||
1533|053|S|doctor has judged that the benefit to you is greater than the||
1533|054|S|risk of side effects. Many people using this medication do not||
1533|055|S|have serious side effects.||
1533|056|S|   Tell your doctor right away if you have any serious side||
1533|057|S|effects, including: stretch marks, skin thinning/discoloration,||
1533|058|S|acne, excessive hair growth, small red bumps on the skin||
1533|059|S|(folliculitis).||
1533|060|S|   Skin infections can become worse when this medication is used.||
1533|061|S|Tell your doctor if redness, swelling, or irritation does not||
1533|062|S|improve.||
1533|063|S|   Rarely, it is possible this medication will be absorbed from||
1533|064|S|the skin into the bloodstream. This can lead to side effects of||
1533|065|S|too much corticosteroid. These side effects are more likely in||
1533|066|S|children, and in people who use this medication for a long time||
1533|067|S|or over large areas of the skin. Tell your doctor right away if||
1533|068|S|any of the following side effects occur: unusual/extreme||
1533|069|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
1533|070|S|thirst/urination, vision problems.||
1533|071|S|   A very serious allergic reaction to this drug is rare.||
1533|072|S|However, get medical help right away if you notice any symptoms||
1533|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1533|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1533|075|S|breathing.||
1533|076|S|   This is not a complete list of possible side effects. If you||
1533|077|S|notice other effects not listed above, contact your doctor or||
1533|078|S|pharmacist.||
1533|079|S|   In the US -||
1533|080|S|   Call your doctor for medical advice about side effects. You||
1533|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1533|082|S|www.fda.gov/medwatch.||
1533|083|S|   In Canada - Call your doctor for medical advice about side||
1533|084|S|effects. You may report side effects to Health Canada at||
1533|085|S|1-866-234-2345.||
1533|086|B|||
1533|087|P|PRECAUTIONS:  Before using desoximetasone, tell your doctor or||
1533|088|P|pharmacist if you are allergic to it; or to other corticosteroids||
1533|089|P|(such as hydrocortisone, prednisone); or if you have any other||
1533|090|P|allergies. This product may contain inactive ingredients, which||
1533|091|P|can cause allergic reactions or other problems. Talk to your||
1533|092|P|pharmacist for more details.||
1533|093|P|   Before using this medication, tell your doctor or pharmacist||
1533|094|P|your medical history, especially of: liver failure, decreased||
1533|095|P|adrenal gland function, current or returning skin infections,||
1533|096|P|open sores.||
1533|097|P|   Do not use on an area where the skin is thinning or if there||
1533|098|P|is an infection or sore present.||
1533|099|P|   Rarely, using corticosteroid medications for a long time or||
1533|100|P|over large areas of skin can make it more difficult for your body||
1533|101|P|to respond to physical stress. Before having surgery or emergency||
1533|102|P|treatment, or if you get a serious illness/injury, tell your||
1533|103|P|doctor or dentist that you are using this medication or have used||
1533|104|P|this medication within the past few months.||
1533|105|P|   During pregnancy, this medication should be used only when||
1533|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
1533|107|P|   It is unknown if this medication, when applied to the skin,||
1533|108|P|passes into breast milk. However, similar drugs, when taken by||
1533|109|P|mouth, pass into breast milk. Consult your doctor before||
1533|110|P|breastfeeding.||
1533|111|B|||
1533|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1533|113|I|medications work or increase your risk for serious side effects.||
1533|114|I|This document does not contain all possible drug interactions.||
1533|115|I|Keep a list of all the products you use (including||
1533|116|I|prescription/nonprescription drugs and herbal products) and share||
1533|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
1533|118|I|the dosage of any medicines without your doctor's approval.||
1533|119|B|||
1533|120|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1533|121|O|has overdosed and has serious symptoms such as passing out or||
1533|122|O|trouble breathing, call 911. Otherwise, call a poison control||
1533|123|O|center right away. US residents can call 1-800-222-1222. Canada||
1533|124|O|residents can call 1-844-764-7669.||
1533|125|B|||
1533|126|N|NOTES:  Do not share this medication with others.||
1533|127|N|   This medication has been prescribed for your current condition||
1533|128|N|only. Do not use it later for other skin problems unless told to||
1533|129|N|do so by your doctor. A different medication may be necessary in||
1533|130|N|that case.||
1533|131|N|   Lab tests (such as adrenal gland function) may be done while||
1533|132|N|you are using this medication, especially if you use this drug||
1533|133|N|for an extended period of time or apply it over large areas of||
1533|134|N|the body. Keep all medical and lab appointments. Consult your||
1533|135|N|doctor for more details.||
1533|136|B|||
1533|137|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1533|138|D|If it is near the time of the next dose, skip the missed dose.||
1533|139|D|Use your next dose at the regular time. Do not double the dose to||
1533|140|D|catch up.||
1533|141|B|||
1533|142|R|STORAGE:  Store at room temperature. This medication is||
1533|143|R|flammable. Keep it away from heat and open flame. Discard||
1533|144|R|medication after 30 days. Keep all medications away from children||
1533|145|R|and pets.||
1533|146|R|   Do not flush medications down the toilet or pour them into a||
1533|147|R|drain unless instructed to do so. Properly discard this product||
1533|148|R|when it is expired or no longer needed. Consult your pharmacist||
1533|149|R|or local waste disposal company.||
1533|150|B|||
1533|151|A|Information last revised July 2025.||
1533|152|A|Copyright(c) 2025 First Databank, Inc.||
1533|153|B|||
1534|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1534|002|Z|does NOT have all possible information about this product. This||
1534|003|Z|information does not assure that this product is safe, effective,||
1534|004|Z|or appropriate for you. This information is not individual||
1534|005|Z|medical advice and does not substitute for the advice of your||
1534|006|Z|health care professional. Always ask your health care||
1534|007|Z|professional for complete information about this product and your||
1534|008|Z|specific health needs.||
1534|009|B|||
1534|010|T|BEDAQUILINE - ORAL||
1534|011|F|(bed-AK-wi-leen)||
1534|012|B|||
1534|013|C|COMMON BRAND NAME(S): Sirturo||
1534|014|B|||
1534|015|W|WARNING:  Bedaquiline may cause a condition that affects the||
1534|016|W|heart rhythm (QT prolongation). The risk of QT prolongation may||
1534|017|W|be increased if you are taking other drugs that may cause QT||
1534|018|W|prolongation. (See also Precautions section).||
1534|019|B|||
1534|020|U|USES:  This medication must be used with other medications to||
1534|021|U|treat active multi-drug-resistant tuberculosis (TB) of the lungs||
1534|022|U|in people with limited treatment options. Bedaquiline belongs to||
1534|023|U|a class of drugs known as antibiotics. It works by stopping the||
1534|024|U|growth of the bacteria that causes TB.||
1534|025|U|   This medication may increase the risk of death. It should only||
1534|026|U|be used when other treatments have not worked.||
1534|027|U|   This antibiotic treats only bacterial infections. It will not||
1534|028|U|work for viral infections (such as common cold, flu). Using any||
1534|029|U|antibiotic when it is not needed can cause it to not work for||
1534|030|U|future infections.||
1534|031|B|||
1534|032|H|HOW TO USE:  Read the Medication Guide provided by your||
1534|033|H|pharmacist before you start taking bedaquiline and each time you||
1534|034|H|get a refill. If you have any questions, ask your doctor or||
1534|035|H|pharmacist.||
1534|036|H|   Take this medication by mouth with food as directed by your||
1534|037|H|doctor, usually once daily for the first 2 weeks, followed by 3||
1534|038|H|times a week for the next 22 weeks. The dosage is based on your||
1534|039|H|medical condition, age, and response to treatment. Children's||
1534|040|H|dosage is also based on weight.||
1534|041|H|   The manufacturer directs to swallow the 100-milligram tablets||
1534|042|H|whole. However, many similar drugs (immediate-release tablets)||
1534|043|H|can be split/crushed. Follow your doctor's direction on how to||
1534|044|H|take this medication.||
1534|045|H|   If you are using the 20-milligram tablets and do not have||
1534|046|H|trouble swallowing tablets, swallow the tablets (whole or split)||
1534|047|H|with water.||
1534|048|H|   If you are using the 20-milligram tablets and have trouble||
1534|049|H|swallowing tablets, you may take your dose 2 different ways: (1)||
1534|050|H|Add your dose (up to 5 tablets) to 1 teaspoonful (5 milliliters)||
1534|051|H|of water in a cup and mix well. You can then either swallow the||
1534|052|H|mixture right away, or you can add the mixture to at least 1||
1534|053|H|teaspoonful (5 milliliters) of beverage or soft food and take||
1534|054|H|right away. Examples of beverages you can take this with include||
1534|055|H|water, milk products, apple juice, orange juice, cranberry juice,||
1534|056|H|or carbonated beverages. Soft foods such as yogurt, apple sauce,||
1534|057|H|mashed banana, or porridge may also be used. Make sure to take||
1534|058|H|all of your dose by rinsing the cup with beverage or soft food||
1534|059|H|and swallowing right away. (2) Crush tablets and mix with soft||
1534|060|H|food. Soft foods such as yogurt, apple sauce, mashed banana, or||
1534|061|H|porridge may be used. Mix well and take all of the mixture right||
1534|062|H|away. Make sure to take all of your dose by adding more soft food||
1534|063|H|and swallowing right away. Do not prepare a mixed dose ahead of||
1534|064|H|time.||
1534|065|H|   The 20-milligram tablets may also be given through a feeding||
1534|066|H|tube. For specific directions, ask your health care professional.||
1534|067|H|   For the best effect, take this antibiotic at evenly spaced||
1534|068|H|times. If you are taking this medication daily, take it at the||
1534|069|H|same time each day. If you are taking this medication 3 times a||
1534|070|H|week, take it at least 48 hours apart on the same days of the||
1534|071|H|week (for example, Mondays, Wednesdays, and Fridays) at the same||
1534|072|H|time of day. To help you remember, mark your calendar with a||
1534|073|H|reminder.||
1534|074|H|   Continue to take this medication (and other TB medications)||
1534|075|H|until the full prescribed amount is finished, even if symptoms||
1534|076|H|disappear after a few days. Stopping the medication too early or||
1534|077|H|skipping doses may result in a return of the infection.||
1534|078|H|   Tell your doctor if your condition lasts or gets worse.||
1534|079|B|||
1534|080|S|SIDE EFFECTS:  See also Warning section.||
1534|081|S|   Nausea, joint pain, and headache may occur. If any of these||
1534|082|S|effects last or get worse, tell your doctor or pharmacist||
1534|083|S|promptly.||
1534|084|S|   Remember that this medication has been prescribed because your||
1534|085|S|doctor has judged that the benefit to you is greater than the||
1534|086|S|risk of side effects. Many people using this medication do not||
1534|087|S|have serious side effects.||
1534|088|S|   Tell your doctor right away if you have any serious side||
1534|089|S|effects, including: symptoms of liver damage (such as||
1534|090|S|nausea/vomiting that doesn't stop, loss of appetite, dark urine,||
1534|091|S|stomach/abdominal pain, yellowing eyes/skin).||
1534|092|S|   Get medical help right away if you have any very serious side||
1534|093|S|effects, including: coughing up blood, chest pain, fast/irregular||
1534|094|S|heartbeat, severe dizziness, fainting.||
1534|095|S|   Bedaquiline can commonly cause a rash that is usually not||
1534|096|S|serious. However, you may not be able to tell it apart from a||
1534|097|S|rare rash that could be a sign of a severe reaction. Tell your||
1534|098|S|doctor right away if you develop any rash.||
1534|099|S|   A very serious allergic reaction to this drug is rare.||
1534|100|S|However, get medical help right away if you notice any symptoms||
1534|101|S|of a serious allergic reaction, including: rash, itching/swelling||
1534|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1534|103|S|breathing.||
1534|104|S|   This is not a complete list of possible side effects. If you||
1534|105|S|notice other effects not listed above, contact your doctor or||
1534|106|S|pharmacist.||
1534|107|S|   In the US -||
1534|108|S|   Call your doctor for medical advice about side effects. You||
1534|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1534|110|S|www.fda.gov/medwatch.||
1534|111|S|   In Canada - Call your doctor for medical advice about side||
1534|112|S|effects. You may report side effects to Health Canada at||
1534|113|S|1-866-234-2345.||
1534|114|B|||
1534|115|P|PRECAUTIONS:  Before taking bedaquiline, tell your doctor or||
1534|116|P|pharmacist if you are allergic to it; or if you have any other||
1534|117|P|allergies. This product may contain inactive ingredients, which||
1534|118|P|can cause allergic reactions or other problems. Talk to your||
1534|119|P|pharmacist for more details.||
1534|120|P|   Before using this medication, tell your doctor or pharmacist||
1534|121|P|your medical history, especially of: liver disease.||
1534|122|P|   Bedaquiline may cause a condition that affects the heart||
1534|123|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1534|124|P|serious (rarely fatal) fast/irregular heartbeat and other||
1534|125|P|symptoms (such as severe dizziness, fainting) that need medical||
1534|126|P|attention right away.||
1534|127|P|   The risk of QT prolongation may be increased if you have||
1534|128|P|certain medical conditions or are taking other drugs that may||
1534|129|P|cause QT prolongation. Before using bedaquiline, tell your doctor||
1534|130|P|or pharmacist of all the drugs you take and if you have any of||
1534|131|P|the following conditions: certain heart problems (heart failure,||
1534|132|P|slow heartbeat, QT prolongation in the EKG), family history of||
1534|133|P|certain heart problems (QT prolongation in the EKG, sudden||
1534|134|P|cardiac death).||
1534|135|P|   Low levels of potassium or magnesium in the blood may also||
1534|136|P|increase your risk of QT prolongation. This risk may increase if||
1534|137|P|you use certain drugs (such as diuretics/"water pills") or if you||
1534|138|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1534|139|P|Talk to your doctor about using bedaquiline safely.||
1534|140|P|   Alcohol may increase the risk of liver disease. Avoid||
1534|141|P|alcoholic beverages while using this medication.||
1534|142|P|   Bedaquiline may cause live bacterial vaccines (such as typhoid||
1534|143|P|vaccine) to not work well. Tell your health care professional||
1534|144|P|that you are using bedaquiline before having any||
1534|145|P|immunizations/vaccinations.||
1534|146|P|   Older adults may be more sensitive to the side effects of this||
1534|147|P|drug, especially QT prolongation (see above).||
1534|148|P|   Before having surgery, tell your doctor or dentist about all||
1534|149|P|the products you use (including prescription drugs,||
1534|150|P|nonprescription drugs, and herbal products).||
1534|151|P|   During pregnancy, this medication should be used only when||
1534|152|P|clearly needed. Discuss the risks and benefits with your doctor.||
1534|153|P|   This medication passes into breast milk and may have||
1534|154|P|undesirable effects on a nursing infant. Consult your doctor||
1534|155|P|before breastfeeding.||
1534|156|B|||
1534|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1534|158|I|medications work or increase your risk for serious side effects.||
1534|159|I|This document does not contain all possible drug interactions.||
1534|160|I|Keep a list of all the products you use (including||
1534|161|I|prescription/nonprescription drugs and herbal products) and share||
1534|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
1534|163|I|the dosage of any medicines without your doctor's approval.||
1534|164|I|   Other medications can affect the removal of bedaquiline from||
1534|165|I|your body, which may affect how bedaquiline works. Examples||
1534|166|I|include efavirenz, rifamycins (such as rifampin, rifapentine),||
1534|167|I|among others.||
1534|168|B|||
1534|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1534|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1534|171|O|poison control center right away. US residents can call||
1534|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1534|173|B|||
1534|174|N|NOTES:  Do not share this medication with others.||
1534|175|N|   This medication has been prescribed for your current condition||
1534|176|N|only. Do not use it later for another infection unless your||
1534|177|N|doctor tells you to.||
1534|178|N|   Lab and/or medical tests (such as liver function, EKG,||
1534|179|N|potassium/calcium/magnesium levels) should be done before you||
1534|180|N|start taking this medication and while you are taking it. Keep||
1534|181|N|all medical and lab appointments. Consult your doctor for more||
1534|182|N|details.||
1534|183|B|||
1534|184|D|MISSED DOSE:  If you miss a daily dose during the first 2 weeks||
1534|185|D|of treatment, skip the missed dose. Take your next dose at the||
1534|186|D|regular time. Do not double the dose to catch up.||
1534|187|D|   If you miss a dose from week 3 onward, take it as soon as you||
1534|188|D|remember, then go back to your usual 3-times-a-week dosing||
1534|189|D|schedule. Make sure that there is at least 24 hours between your||
1534|190|D|doses and that you do not take more than the weekly dose in a||
1534|191|D|7-day period. If you are unsure of what to do after a missed||
1534|192|D|dose, talk to your doctor or pharmacist.||
1534|193|B|||
1534|194|R|STORAGE:  Store in the original container at room temperature||
1534|195|R|away from light and moisture. Do not store in the bathroom. Keep||
1534|196|R|the drying agent (desiccant) in the bottle if you are using the||
1534|197|R|20-milligram tablets. If needed, the 100-milligram tablets may be||
1534|198|R|stored in another container for up to 3 months. Tightly close the||
1534|199|R|bottle when not in use. Keep all medications away from children||
1534|200|R|and pets.||
1534|201|R|   Do not flush medications down the toilet or pour them into a||
1534|202|R|drain unless instructed to do so. Properly discard this product||
1534|203|R|when it is expired or no longer needed. Consult your pharmacist||
1534|204|R|or local waste disposal company.||
1534|205|B|||
1534|206|A|Information last revised October 2024.||
1534|207|A|Copyright(c) 2025 First Databank, Inc.||
1534|208|B|||
1535|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1535|002|Z|does NOT have all possible information about this product. This||
1535|003|Z|information does not assure that this product is safe, effective,||
1535|004|Z|or appropriate for you. This information is not individual||
1535|005|Z|medical advice and does not substitute for the advice of your||
1535|006|Z|health care professional. Always ask your health care||
1535|007|Z|professional for complete information about this product and your||
1535|008|Z|specific health needs.||
1535|009|B|||
1535|010|T|PIRFENIDONE - ORAL||
1535|011|F|(pir-FEN-i-done)||
1535|012|B|||
1535|013|C|COMMON BRAND NAME(S): Esbriet||
1535|014|B|||
1535|015|U|USES:  Pirfenidone is used to treat a certain lung disease called||
1535|016|U|idiopathic pulmonary fibrosis (IPF). This disease causes the||
1535|017|U|lungs to get scarred and become stiff, making it hard to breathe.||
1535|018|U|Pirfenidone may help slow down the worsening of your IPF.||
1535|019|B|||
1535|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1535|021|H|from your pharmacist before you start taking pirfenidone and each||
1535|022|H|time you get a refill. If you have any questions, ask your doctor||
1535|023|H|or pharmacist.||
1535|024|H|   Take this medication by mouth with food as directed by your||
1535|025|H|doctor, usually 3 times a day. Taking pirfenidone with food may||
1535|026|H|help decrease dizziness and nausea. To reduce your risk of side||
1535|027|H|effects, your doctor may direct you to start this medication at a||
1535|028|H|low dose and gradually increase your dose. Follow your doctor's||
1535|029|H|instructions carefully.||
1535|030|H|   The dosage is based on your medical condition, response to||
1535|031|H|treatment, and other medications you may be taking. Be sure to||
1535|032|H|tell your doctor and pharmacist about all the products you use||
1535|033|H|(including prescription drugs, nonprescription drugs, and herbal||
1535|034|H|products).||
1535|035|H|   Take this medication regularly to get the most benefit from||
1535|036|H|it. To help you remember, take it at the same times each day.||
1535|037|H|   Tell your doctor if your condition gets worse.||
1535|038|B|||
1535|039|S|SIDE EFFECTS:  Tiredness, lack of energy, loss of appetite,||
1535|040|S|weight loss, or changes in taste may occur. Dizziness, nausea,||
1535|041|S|upset stomach, vomiting, diarrhea, or heartburn may also occur||
1535|042|S|but taking pirfenidone with food may lessen these side effects.||
1535|043|S|If any of these effects last or get worse, tell your doctor or||
1535|044|S|pharmacist promptly.||
1535|045|S|   Remember that this medication has been prescribed because your||
1535|046|S|doctor has judged that the benefit to you is greater than the||
1535|047|S|risk of side effects. Many people using this medication do not||
1535|048|S|have serious side effects.||
1535|049|S|   Pirfenidone may rarely cause serious liver disease. Get||
1535|050|S|medical help right away if you have any symptoms of liver damage,||
1535|051|S|including: nausea/vomiting that doesn't stop, loss of appetite,||
1535|052|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
1535|053|S|   A very serious allergic reaction to this drug is rare.||
1535|054|S|However, get medical help right away if you notice any symptoms||
1535|055|S|of a serious allergic reaction, including: fever, swollen lymph||
1535|056|S|nodes, rash/blisters, mouth sores, itching/swelling (especially||
1535|057|S|of the face/tongue/throat), severe dizziness, trouble breathing.||
1535|058|S|   This is not a complete list of possible side effects. If you||
1535|059|S|notice other effects not listed above, contact your doctor or||
1535|060|S|pharmacist.||
1535|061|S|   In the US -||
1535|062|S|   Call your doctor for medical advice about side effects. You||
1535|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1535|064|S|www.fda.gov/medwatch.||
1535|065|S|   In Canada - Call your doctor for medical advice about side||
1535|066|S|effects. You may report side effects to Health Canada at||
1535|067|S|1-866-234-2345.||
1535|068|B|||
1535|069|P|PRECAUTIONS:  Before taking pirfenidone tell your doctor or||
1535|070|P|pharmacist if you are allergic to it; or if you have any other||
1535|071|P|allergies. This product may contain inactive ingredients, which||
1535|072|P|can cause allergic reactions or other problems. Talk to your||
1535|073|P|pharmacist for more details.||
1535|074|P|   Before using this medication, tell your doctor or pharmacist||
1535|075|P|your medical history, especially of: liver disease, kidney||
1535|076|P|disease (such as dialysis).||
1535|077|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1535|078|P|can make you more dizzy. Do not drive, use machinery, or do||
1535|079|P|anything that needs alertness until you can do it safely. Limit||
1535|080|P|alcoholic beverages. Talk to your doctor if you are using||
1535|081|P|marijuana (cannabis).||
1535|082|P|   This medication may make you more sensitive to the sun. Limit||
1535|083|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1535|084|P|sunscreen and wear protective clothing when outdoors. Tell your||
1535|085|P|doctor right away if you get sunburned or have skin||
1535|086|P|blisters/redness.||
1535|087|P|   Before having surgery, tell your doctor or dentist about all||
1535|088|P|the products you use (including prescription drugs,||
1535|089|P|nonprescription drugs, and herbal products).||
1535|090|P|   During pregnancy, this medication should be used only when||
1535|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
1535|092|P|   It is unknown if this medication passes into breast milk.||
1535|093|P|Consult your doctor before breastfeeding.||
1535|094|B|||
1535|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1535|096|I|medications work or increase your risk for serious side effects.||
1535|097|I|This document does not contain all possible drug interactions.||
1535|098|I|Keep a list of all the products you use (including||
1535|099|I|prescription/nonprescription drugs and herbal products) and share||
1535|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
1535|101|I|the dosage of any medicines without your doctor's approval.||
1535|102|I|   Other medications can affect the removal of pirfenidone from||
1535|103|I|your body, which may affect how pirfenidone works. Examples||
1535|104|I|include rifamycins (such as rifampin), drugs used to treat||
1535|105|I|seizures (such as phenytoin), among others.||
1535|106|I|   Cigarette smoking decreases blood levels of this medication.||
1535|107|I|Tell your doctor if you smoke or if you have recently stopped||
1535|108|I|smoking.||
1535|109|B|||
1535|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1535|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1535|112|O|poison control center right away. US residents can call||
1535|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1535|114|B|||
1535|115|N|NOTES:  Do not share this medication with others.||
1535|116|N|   Lab and/or medical tests (such as weight, liver function)||
1535|117|N|should be done before you start taking this medication and while||
1535|118|N|you are taking it. Keep all medical and lab appointments. Consult||
1535|119|N|your doctor for more details.||
1535|120|B|||
1535|121|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1535|122|D|remember. If it is near the time of the next dose, skip the||
1535|123|D|missed dose. Take your next dose at the regular time. Do not||
1535|124|D|double the dose to catch up.||
1535|125|D|   If you miss 14 days or more of treatment in a row, you may||
1535|126|D|have to restart treatment with a lower dose. Ask your doctor for||
1535|127|D|more details.||
1535|128|B|||
1535|129|R|STORAGE:  Store at room temperature away from light and moisture.||
1535|130|R|Do not store in the bathroom. Keep all medications away from||
1535|131|R|children and pets.||
1535|132|R|   Do not flush medications down the toilet or pour them into a||
1535|133|R|drain unless instructed to do so. Properly discard this product||
1535|134|R|when it is expired or no longer needed. Consult your pharmacist||
1535|135|R|or local waste disposal company.||
1535|136|B|||
1535|137|A|Information last revised November 2024.||
1535|138|A|Copyright(c) 2025 First Databank, Inc.||
1535|139|B|||
1536|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1536|002|Z|does NOT have all possible information about this product. This||
1536|003|Z|information does not assure that this product is safe, effective,||
1536|004|Z|or appropriate for you. This information is not individual||
1536|005|Z|medical advice and does not substitute for the advice of your||
1536|006|Z|health care professional. Always ask your health care||
1536|007|Z|professional for complete information about this product and your||
1536|008|Z|specific health needs.||
1536|009|B|||
1536|010|T|CYSTEAMINE - OPHTHALMIC||
1536|011|F|(sis-TEE-a-meen)||
1536|012|B|||
1536|013|C|COMMON BRAND NAME(S): Cystaran||
1536|014|B|||
1536|015|U|USES:  Cysteamine is used to treat eye problems in people with||
1536|016|U|cystinosis, a hereditary metabolic disorder that causes build-up||
1536|017|U|of a certain natural substance (cystine) in the body. This||
1536|018|U|medication helps get rid of cystine build-up in the eyes.||
1536|019|B|||
1536|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1536|021|H|from your pharmacist before you start using cysteamine and each||
1536|022|H|time you get a refill. If you have any questions, ask your doctor||
1536|023|H|or pharmacist.||
1536|024|H|   Use this medication in the affected eye(s) as directed by your||
1536|025|H|doctor, usually once every hour you are awake.||
1536|026|H|   Some brands of this medication are stored in the freezer,||
1536|027|H|while others are stored in the refrigerator. Read and follow the||
1536|028|H|manufacturer's directions for how to store your brand before and||
1536|029|H|after first use.||
1536|030|H|   Use this medication in the eyes as directed by your doctor.||
1536|031|H|   To apply eye drops, wash hands first. To avoid contamination,||
1536|032|H|do not touch the dropper tip or let it touch your eye or any||
1536|033|H|other surface.||
1536|034|H|   If you are wearing contact lenses, remove them before using||
1536|035|H|eye drops. Wait at least 15 minutes before replacing your contact||
1536|036|H|lenses. Tilt your head back, look upward, and pull down the lower||
1536|037|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1536|038|H|and place one drop into the pouch. Look downward, gently close||
1536|039|H|your eyes, and place one finger at the corner of your eye (near||
1536|040|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
1536|041|H|opening your eyes. This will prevent the medication from draining||
1536|042|H|out. Try not to blink or rub your eye. Repeat these steps for||
1536|043|H|your other eye. Do not rinse the dropper. Replace the dropper cap||
1536|044|H|after each use.||
1536|045|H|   If you are using another kind of eye medication (such as drops||
1536|046|H|or ointments), wait at least 5 or at least 10 minutes (depending||
1536|047|H|on your brand) before applying other medications. Use eye drops||
1536|048|H|before eye ointments to allow the drops to enter the eye.||
1536|049|H|   Wait several minutes for your vision to clear before driving||
1536|050|H|or operating machinery.||
1536|051|H|   Use this medication regularly to get the most benefit from it.||
1536|052|B|||
1536|053|S|SIDE EFFECTS:  Temporary eye discomfort, itching, pain, redness,||
1536|054|S|blurred vision, sensitivity to light, or vision changes may||
1536|055|S|occur. Eyelid swelling, watery eyes, or headache may also occur.||
1536|056|S|If any of these effects last or get worse, tell your doctor or||
1536|057|S|pharmacist promptly.||
1536|058|S|   Remember that this medication has been prescribed because your||
1536|059|S|doctor has judged that the benefit to you is greater than the||
1536|060|S|risk of side effects. Many people using this medication do not||
1536|061|S|have serious side effects.||
1536|062|S|   A very serious allergic reaction to this drug is rare.||
1536|063|S|However, get medical help right away if you notice any symptoms||
1536|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1536|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1536|066|S|breathing.||
1536|067|S|   This is not a complete list of possible side effects. If you||
1536|068|S|notice other effects not listed above, contact your doctor or||
1536|069|S|pharmacist.||
1536|070|S|   In the US -||
1536|071|S|   Call your doctor for medical advice about side effects. You||
1536|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1536|073|S|www.fda.gov/medwatch.||
1536|074|S|   In Canada - Call your doctor for medical advice about side||
1536|075|S|effects. You may report side effects to Health Canada at||
1536|076|S|1-866-234-2345.||
1536|077|B|||
1536|078|P|PRECAUTIONS:  Before using cysteamine, tell your doctor or||
1536|079|P|pharmacist if you are allergic to it; or if you have any other||
1536|080|P|allergies. This product may contain inactive ingredients, which||
1536|081|P|can cause allergic reactions or other problems. Talk to your||
1536|082|P|pharmacist for more details.||
1536|083|P|   After you apply this drug, your vision may become temporarily||
1536|084|P|blurred or you may have some vision changes. Do not drive, use||
1536|085|P|machinery, or do anything that needs clear vision until you can||
1536|086|P|do it safely.||
1536|087|P|   Before having surgery, tell your doctor or dentist about all||
1536|088|P|the products you use (including prescription drugs,||
1536|089|P|nonprescription drugs, and herbal products).||
1536|090|P|   During pregnancy, this medication should be used only when||
1536|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
1536|092|P|   It is unknown if this drug passes into breast milk. Consult||
1536|093|P|your doctor before breastfeeding.||
1536|094|B|||
1536|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1536|096|I|medications work or increase your risk for serious side effects.||
1536|097|I|This document does not contain all possible drug interactions.||
1536|098|I|Keep a list of all the products you use (including||
1536|099|I|prescription/nonprescription drugs and herbal products) and share||
1536|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
1536|101|I|the dosage of any medicines without your doctor's approval.||
1536|102|B|||
1536|103|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1536|104|O|has overdosed and has serious symptoms such as passing out or||
1536|105|O|trouble breathing, call 911. Otherwise, call a poison control||
1536|106|O|center right away. US residents can call 1-800-222-1222. Canada||
1536|107|O|residents can call 1-844-764-7669.||
1536|108|B|||
1536|109|N|NOTES:  Do not share this medication with others.||
1536|110|N|   Lab and/or medical tests (such as eye exams) may be done while||
1536|111|N|you are using this medication. Keep all medical and lab||
1536|112|N|appointments. Consult your doctor for more details.||
1536|113|B|||
1536|114|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1536|115|D|If it is near the time of the next dose, skip the missed dose.||
1536|116|D|Use your next dose at the regular time. Do not double the dose to||
1536|117|D|catch up.||
1536|118|B|||
1536|119|R|STORAGE:  Different brands of this medication have different||
1536|120|R|storage needs. Check the product package for instructions on how||
1536|121|R|to store your brand, or ask your pharmacist. Keep all medications||
1536|122|R|away from children and pets.||
1536|123|R|   Do not flush medications down the toilet or pour them into a||
1536|124|R|drain unless instructed to do so. Properly discard this product||
1536|125|R|when it is expired or no longer needed. Consult your pharmacist||
1536|126|R|or local waste disposal company.||
1536|127|B|||
1536|128|A|Information last revised February 2025.||
1536|129|A|Copyright(c) 2025 First Databank, Inc.||
1536|130|B|||
1537|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1537|002|Z|does NOT have all possible information about this product. This||
1537|003|Z|information does not assure that this product is safe, effective,||
1537|004|Z|or appropriate for you. This information is not individual||
1537|005|Z|medical advice and does not substitute for the advice of your||
1537|006|Z|health care professional. Always ask your health care||
1537|007|Z|professional for complete information about this product and your||
1537|008|Z|specific health needs.||
1537|009|B|||
1537|010|T|BRINZOLAMIDE/BRIMONIDINE SUSPENSION - OPHTHALMIC||
1537|011|F|(brin-ZOE-la-mide/bri-MON-i-deen)||
1537|012|B|||
1537|013|C|COMMON BRAND NAME(S): Simbrinza||
1537|014|B|||
1537|015|U|USES:  This product contains two medications used to treat high||
1537|016|U|pressure in the eye due to glaucoma (open-angle glaucoma-type) or||
1537|017|U|a certain other eye disease (ocular hypertension). Lowering high||
1537|018|U|pressure in the eye reduces the risk of vision loss, nerve||
1537|019|U|damage, or blindness. This product contains brinzolamide and||
1537|020|U|brimonidine. These two medications work together to decrease the||
1537|021|U|amount of fluid within the eye. Brinzolamide belongs to a class||
1537|022|U|of drugs known as carbonic anhydrase inhibitors. Brimonidine||
1537|023|U|belongs to a class of drugs known as alpha agonists.||
1537|024|U|   This product is not recommended for use in children younger||
1537|025|U|than 2 years of age due to an increased risk of serious side||
1537|026|U|effects such as very slowed breathing. Ask the doctor or||
1537|027|U|pharmacist for details.||
1537|028|B|||
1537|029|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1537|030|H|directed by your doctor, usually 3 times daily. Shake the bottle||
1537|031|H|well before each dose.||
1537|032|H|   To apply eye drops, wash hands first. To avoid contamination,||
1537|033|H|do not touch the dropper tip or let it touch your eye or any||
1537|034|H|other surface.||
1537|035|H|   The preservative in this product may be absorbed by contact||
1537|036|H|lenses. If you are wearing contact lenses, remove them before||
1537|037|H|using eye drops. Wait at least 15 minutes before replacing your||
1537|038|H|contact lenses.||
1537|039|H|   Tilt your head back, look upward, and pull down the lower||
1537|040|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1537|041|H|and place one drop into the pouch. Look downward, gently close||
1537|042|H|your eyes, and place one finger at the corner of your eye (near||
1537|043|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
1537|044|H|opening your eyes. This will prevent the medication from draining||
1537|045|H|out. Try not to blink or rub your eye. If directed to use this||
1537|046|H|medication in both eyes, repeat these steps for your other eye.||
1537|047|H|Do not rinse the dropper. Replace the dropper cap after each use.||
1537|048|H|   If you are using another kind of eye medication (such as drops||
1537|049|H|or ointments), wait at least 5 minutes before applying other||
1537|050|H|medications. Use eye drops before eye ointments to allow the||
1537|051|H|drops to enter the eye.||
1537|052|H|   Wait several minutes for your vision to clear before driving||
1537|053|H|or operating machinery.||
1537|054|H|   Use this medication regularly to get the most benefit from it.||
1537|055|H|To help you remember, use it at the same time(s) each day. Keep||
1537|056|H|using this medication even if you feel well. Most people with||
1537|057|H|glaucoma or high pressure in the eye do not feel sick.||
1537|058|B|||
1537|059|S|SIDE EFFECTS:  Eye discomfort/itching/redness/discharge,||
1537|060|S|temporary blurred vision, dry eyes, feeling as if something is in||
1537|061|S|your eye, dry mouth, bitter/sour/unusual taste in your mouth,||
1537|062|S|dizziness, drowsiness, tiredness, and headache may occur. If any||
1537|063|S|of these effects last or get worse, tell your doctor or||
1537|064|S|pharmacist promptly.||
1537|065|S|   Remember that this medication has been prescribed because your||
1537|066|S|doctor has judged that the benefit to you is greater than the||
1537|067|S|risk of side effects. Many people using this medication do not||
1537|068|S|have serious side effects.||
1537|069|S|   Tell your doctor right away if you have any serious side||
1537|070|S|effects, including: fast/pounding heartbeat, eye or eyelid||
1537|071|S|pain/burning/swelling, extreme sensitivity to light, vision||
1537|072|S|changes.||
1537|073|S|   Get medical help right away if you have any very serious side||
1537|074|S|effects, including: fainting, slow/irregular heartbeat.||
1537|075|S|   A very serious allergic reaction to this drug is rare.||
1537|076|S|However, get medical help right away if you notice any symptoms||
1537|077|S|of a serious allergic reaction, including: rash, itching/swelling||
1537|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1537|079|S|breathing.||
1537|080|S|   This is not a complete list of possible side effects. If you||
1537|081|S|notice other effects not listed above, contact your doctor or||
1537|082|S|pharmacist.||
1537|083|S|   In the US -||
1537|084|S|   Call your doctor for medical advice about side effects. You||
1537|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1537|086|S|www.fda.gov/medwatch.||
1537|087|S|   In Canada - Call your doctor for medical advice about side||
1537|088|S|effects. You may report side effects to Health Canada at||
1537|089|S|1-866-234-2345.||
1537|090|B|||
1537|091|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1537|092|P|pharmacist if you are allergic to it; or to apraclonidine; or if||
1537|093|P|you have any other allergies. This product may contain inactive||
1537|094|P|ingredients, which can cause allergic reactions or other||
1537|095|P|problems. Talk to your pharmacist for more details.||
1537|096|P|   Before using this product, tell your doctor or pharmacist your||
1537|097|P|medical history, especially of: blood vessel diseases (such as||
1537|098|P|thromboangiitis obliterans), blood circulation disorders (such as||
1537|099|P|cerebral or coronary insufficiency), depression, heart disease,||
1537|100|P|kidney disease, liver disease, Raynaud's disease, low blood||
1537|101|P|pressure upon standing (orthostatic hypotension).||
1537|102|P|   This drug may make you dizzy or drowsy. After you apply this||
1537|103|P|product, your vision may become temporarily blurred. Alcohol or||
1537|104|P|marijuana (cannabis) can make you more dizzy or drowsy. Do not||
1537|105|P|drive, use machinery, or do anything that needs alertness or||
1537|106|P|clear vision until you can do it safely. Limit alcoholic||
1537|107|P|beverages. Talk to your doctor if you are using marijuana||
1537|108|P|(cannabis).||
1537|109|P|   If you develop an eye infection or injury, or have eye||
1537|110|P|surgery, check with your doctor about whether you should continue||
1537|111|P|to use your current bottle of brinzolamide/brimonidine. You may||
1537|112|P|be advised to start using a new bottle.||
1537|113|P|   Before having surgery, tell your doctor or dentist about all||
1537|114|P|the products you use (including prescription drugs,||
1537|115|P|nonprescription drugs, and herbal products).||
1537|116|P|   Children may be more sensitive to the side effects of this||
1537|117|P|drug, especially drowsiness.||
1537|118|P|   During pregnancy, this product should be used only when||
1537|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
1537|120|P|   It is unknown if this product passes into breast milk. Consult||
1537|121|P|your doctor before breastfeeding.||
1537|122|B|||
1537|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1537|124|I|medications work or increase your risk for serious side effects.||
1537|125|I|This document does not contain all possible drug interactions.||
1537|126|I|Keep a list of all the products you use (including||
1537|127|I|prescription/nonprescription drugs and herbal products) and share||
1537|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
1537|129|I|the dosage of any medicines without your doctor's approval.||
1537|130|I|   Tell your doctor or pharmacist if you are taking other||
1537|131|I|products that cause drowsiness including alcohol, marijuana||
1537|132|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1537|133|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1537|134|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1537|135|I|codeine).||
1537|136|I|   Check the labels on all your medicines (such as allergy or||
1537|137|I|cough-and-cold products) because they may contain ingredients||
1537|138|I|that cause drowsiness. Ask your pharmacist about using those||
1537|139|I|products safely.||
1537|140|B|||
1537|141|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1537|142|O|has overdosed and has serious symptoms such as passing out or||
1537|143|O|trouble breathing, call 911. Otherwise, call a poison control||
1537|144|O|center right away. US residents can call 1-800-222-1222. Canada||
1537|145|O|residents can call 1-844-764-7669.||
1537|146|B|||
1537|147|N|NOTES:  Do not share this medication with others.||
1537|148|N|   Lab and/or medical tests (such as measuring intraocular||
1537|149|N|pressure) may be done while you are using this medication. Keep||
1537|150|N|all medical and lab appointments. Consult your doctor for more||
1537|151|N|details.||
1537|152|B|||
1537|153|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1537|154|D|If it is near the time of the next dose, skip the missed dose.||
1537|155|D|Use your next dose at the regular time. Do not double the dose to||
1537|156|D|catch up.||
1537|157|B|||
1537|158|R|STORAGE:  Store at room temperature or in the refrigerator. Keep||
1537|159|R|all medications away from children and pets.||
1537|160|R|   Do not flush medications down the toilet or pour them into a||
1537|161|R|drain unless instructed to do so. Properly discard this product||
1537|162|R|when it is expired or no longer needed. Consult your pharmacist||
1537|163|R|or local waste disposal company.||
1537|164|B|||
1537|165|A|Information last revised May 2024.||
1537|166|A|Copyright(c) 2025 First Databank, Inc.||
1537|167|B|||
1538|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1538|002|Z|does NOT have all possible information about this product. This||
1538|003|Z|information does not assure that this product is safe, effective,||
1538|004|Z|or appropriate for you. This information is not individual||
1538|005|Z|medical advice and does not substitute for the advice of your||
1538|006|Z|health care professional. Always ask your health care||
1538|007|Z|professional for complete information about this product and your||
1538|008|Z|specific health needs.||
1538|009|B|||
1538|010|T|MEMANTINE EXTENDED-RELEASE - ORAL||
1538|011|F|(MEM-an-teen)||
1538|012|B|||
1538|013|C|COMMON BRAND NAME(S): Namenda XR||
1538|014|B|||
1538|015|U|USES:  Memantine is used to treat moderate to severe confusion||
1538|016|U|(dementia) related to Alzheimer's disease. It does not cure||
1538|017|U|Alzheimer's disease, but it may improve memory, awareness, and||
1538|018|U|the ability to perform daily functions. This medication works by||
1538|019|U|blocking the action of a certain natural substance in the brain||
1538|020|U|(glutamate) that is believed to be linked to symptoms of||
1538|021|U|Alzheimer's disease.||
1538|022|B|||
1538|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1538|024|H|from your pharmacist before you start taking memantine and each||
1538|025|H|time you get a refill. If you have any questions, ask your doctor||
1538|026|H|or pharmacist.||
1538|027|H|   Take this medication by mouth with or without food as directed||
1538|028|H|by your doctor, usually once daily. Swallow the capsules whole.||
1538|029|H|Do not crush or chew the capsules. Doing so can release all of||
1538|030|H|the drug at once, increasing the risk of side effects. If you||
1538|031|H|have trouble swallowing the capsules whole, the capsule may be||
1538|032|H|opened and the contents may be sprinkled on applesauce. Swallow||
1538|033|H|all of the drug/food mixture right away without chewing. Do not||
1538|034|H|prepare a supply in advance.||
1538|035|H|   The dosage is based on your medical condition and response to||
1538|036|H|treatment. To reduce your risk of side effects, your doctor may||
1538|037|H|direct you to start this medication at a low dose and gradually||
1538|038|H|increase your dose. Follow your doctor's instructions carefully.||
1538|039|H|   If switching from another form of memantine to the||
1538|040|H|extended-release form, follow your doctor's instructions||
1538|041|H|carefully. Do not switch forms of memantine without talking to||
1538|042|H|your doctor first.||
1538|043|H|   Use this medication regularly to get the most benefit from it.||
1538|044|H|To help you remember, take it at the same time each day.||
1538|045|H|   Tell your doctor if your condition gets worse.||
1538|046|B|||
1538|047|S|SIDE EFFECTS:  Back pain, dizziness, drowsiness, constipation,||
1538|048|S|increased weight, stomach pain, vomiting, and loss of bladder||
1538|049|S|control may occur. If any of these effects last or get worse,||
1538|050|S|tell your doctor or pharmacist promptly.||
1538|051|S|   Remember that this medication has been prescribed because your||
1538|052|S|doctor has judged that the benefit to you is greater than the||
1538|053|S|risk of side effects. Many people using this medication do not||
1538|054|S|have serious side effects.||
1538|055|S|   Tell your doctor right away if you have any serious side||
1538|056|S|effects, including: mental/mood changes (such as depression,||
1538|057|S|aggression).||
1538|058|S|   A very serious allergic reaction to this drug is rare.||
1538|059|S|However, get medical help right away if you notice any symptoms||
1538|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1538|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1538|062|S|breathing.||
1538|063|S|   This is not a complete list of possible side effects. If you||
1538|064|S|notice other effects not listed above, contact your doctor or||
1538|065|S|pharmacist.||
1538|066|S|   In the US -||
1538|067|S|   Call your doctor for medical advice about side effects. You||
1538|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1538|069|S|www.fda.gov/medwatch.||
1538|070|S|   In Canada - Call your doctor for medical advice about side||
1538|071|S|effects. You may report side effects to Health Canada at||
1538|072|S|1-866-234-2345.||
1538|073|B|||
1538|074|P|PRECAUTIONS:  Before taking memantine, tell your doctor or||
1538|075|P|pharmacist if you are allergic to it; or if you have any other||
1538|076|P|allergies. This product may contain inactive ingredients, which||
1538|077|P|can cause allergic reactions or other problems. Talk to your||
1538|078|P|pharmacist for more details.||
1538|079|P|   Before using this medication, tell your doctor or pharmacist||
1538|080|P|your medical history, especially of: kidney problems, severe||
1538|081|P|urinary tract infections, recent dietary change (from a||
1538|082|P|high-protein diet to a vegetarian diet).||
1538|083|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1538|084|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1538|085|P|machinery, or do anything that needs alertness until you can do||
1538|086|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1538|087|P|are using marijuana (cannabis).||
1538|088|P|   Before having surgery, tell your doctor or dentist about all||
1538|089|P|the products you use (including prescription drugs,||
1538|090|P|nonprescription drugs, and herbal products).||
1538|091|P|   During pregnancy, this medication should be used only when||
1538|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
1538|093|P|   It is unknown if this medication passes into breast milk.||
1538|094|P|Consult your doctor before breastfeeding.||
1538|095|B|||
1538|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1538|097|I|medications work or increase your risk for serious side effects.||
1538|098|I|This document does not contain all possible drug interactions.||
1538|099|I|Keep a list of all the products you use (including||
1538|100|I|prescription/nonprescription drugs and herbal products) and share||
1538|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
1538|102|I|the dosage of any medicines without your doctor's approval.||
1538|103|I|   Some products that may interact with this drug include:||
1538|104|I|carbonic anhydrase inhibitors (such as acetazolamide,||
1538|105|I|methazolamide), sodium bicarbonate.||
1538|106|B|||
1538|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1538|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1538|109|O|poison control center right away. US residents can call||
1538|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1538|111|O|Symptoms of overdose may include: restlessness, personality||
1538|112|O|change, hallucinations, loss of consciousness.||
1538|113|B|||
1538|114|N|NOTES:  Do not share this medication with others.||
1538|115|B|||
1538|116|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1538|117|D|remember. If it is near the time of the next dose, skip the||
1538|118|D|missed dose. Take your next dose at the regular time. Do not||
1538|119|D|double the dose to catch up.||
1538|120|D|   If you forget to take memantine for several days, talk to your||
1538|121|D|doctor before your next dose. You may need to start at a lower||
1538|122|D|dose again and slowly increase it.||
1538|123|B|||
1538|124|R|STORAGE:  Store at room temperature away from light and moisture.||
1538|125|R|Do not store in the bathroom. Keep all medications away from||
1538|126|R|children and pets.||
1538|127|R|   Do not flush medications down the toilet or pour them into a||
1538|128|R|drain unless instructed to do so. Properly discard this product||
1538|129|R|when it is expired or no longer needed. Consult your pharmacist||
1538|130|R|or local waste disposal company.||
1538|131|B|||
1538|132|A|Information last revised November 2024.||
1538|133|A|Copyright(c) 2025 First Databank, Inc.||
1538|134|B|||
1539|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1539|002|Z|does NOT have all possible information about this product. This||
1539|003|Z|information does not assure that this product is safe, effective,||
1539|004|Z|or appropriate for you. This information is not individual||
1539|005|Z|medical advice and does not substitute for the advice of your||
1539|006|Z|health care professional. Always ask your health care||
1539|007|Z|professional for complete information about this product and your||
1539|008|Z|specific health needs.||
1539|009|B|||
1539|010|T|EVEROLIMUS TABLET - FOR ORAL SUSPENSION||
1539|011|F|(E-ver-OH-li-mus)||
1539|012|B|||
1539|013|C|COMMON BRAND NAME(S): Afinitor Disperz||
1539|014|B|||
1539|015|U|USES:  Everolimus is used to treat a certain type of benign||
1539|016|U|(non-cancerous) brain tumor in people with a certain genetic||
1539|017|U|disorder (tuberous sclerosis complex). It works by slowing or||
1539|018|U|stopping the growth of tumor cells. Everolimus is also used with||
1539|019|U|other medications to treat certain types of seizures in people||
1539|020|U|with tuberous sclerosis complex. Everolimus may reduce the number||
1539|021|U|of seizures you have.||
1539|022|B|||
1539|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1539|024|H|from your pharmacist before you start taking everolimus and each||
1539|025|H|time you get a refill. If you have any questions, ask your doctor||
1539|026|H|or pharmacist.||
1539|027|H|   Do not change dosage forms of this medication without checking||
1539|028|H|with your doctor or pharmacist.||
1539|029|H|   Take this medication by mouth as directed by your doctor,||
1539|030|H|usually once daily. You may take this medication with or without||
1539|031|H|food, but it is important to choose one way and take this||
1539|032|H|medication the same way with every dose.||
1539|033|H|   Do not swallow the tablet whole. This medication must be||
1539|034|H|dispersed in water before swallowing. If another person is||
1539|035|H|helping you prepare this medication, he/she should wear gloves||
1539|036|H|while preparing each dose to avoid possible contact with||
1539|037|H|everolimus.||
1539|038|H|   Do not disperse more than 10 milligrams total at a time. You||
1539|039|H|may use an oral syringe or a drinking glass (see instructions in||
1539|040|H|the package). If you are using an oral syringe, place the||
1539|041|H|medication into a 10-milliliter syringe. Do not break or crush||
1539|042|H|the tablet(s). Draw 1 teaspoon (5 milliliters) of water into the||
1539|043|H|syringe. Place the filled syringe into a container (tip up) for 3||
1539|044|H|minutes to allow the tablet(s) to disperse. Gently swirl the||
1539|045|H|syringe 5 times before taking the medication. To make sure you||
1539|046|H|have taken the whole dose, draw another teaspoon (5 milliliters)||
1539|047|H|of water into the syringe, swirl, and take the rest of the||
1539|048|H|mixture.||
1539|049|H|   If you are using a drinking glass, place the medication in a||
1539|050|H|glass with about 5 teaspoons (25 milliliters) of water. Do not||
1539|051|H|use other liquids. Do not break or crush the tablet(s). After 3||
1539|052|H|minutes, stir the mixture gently with a spoon, then drink all of||
1539|053|H|the mixture right away. To make sure you have taken the whole||
1539|054|H|dose, add another 5 teaspoons (25 milliliters) of water to the||
1539|055|H|glass to rinse it, and drink all the rinse water.||
1539|056|H|   Take this medication within 60 minutes of mixing.||
1539|057|H|   The dosage is based on your medical condition, body size,||
1539|058|H|response to treatment, lab tests, and other medications you may||
1539|059|H|be taking. Be sure to tell your doctor and pharmacist about all||
1539|060|H|the products you use (including prescription drugs,||
1539|061|H|nonprescription drugs, and herbal products).||
1539|062|H|   Use this medication regularly to get the most benefit from it.||
1539|063|H|To help you remember, take it at the same time each day.||
1539|064|H|   Do not increase your dose or use this drug more often or for||
1539|065|H|longer than prescribed. Your condition will not improve any||
1539|066|H|faster, and your risk of serious side effects will increase.||
1539|067|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1539|068|H|using this medication unless your doctor or pharmacist says you||
1539|069|H|may do so safely. Grapefruit can increase the chance of side||
1539|070|H|effects with this medicine. Ask your doctor or pharmacist for||
1539|071|H|more details.||
1539|072|H|   Since this drug can be absorbed through the skin and lungs and||
1539|073|H|may harm an unborn baby, women who are pregnant or who may become||
1539|074|H|pregnant should not handle this medication or breathe the dust||
1539|075|H|from the tablets.||
1539|076|B|||
1539|077|S|SIDE EFFECTS:  Diarrhea, nausea/vomiting, decreased appetite,||
1539|078|S|weight loss, changes in taste, nosebleeds, dry skin, dizziness,||
1539|079|S|and headache may occur. If any of these effects last or get||
1539|080|S|worse, tell your doctor or pharmacist promptly.||
1539|081|S|   Pain or sores in the mouth and throat may occur. To reduce the||
1539|082|S|risk of getting mouth sores when you start everolimus treatment,||
1539|083|S|your doctor may prescribe a mouthwash that contains a||
1539|084|S|corticosteroid medication. Brush your teeth carefully/gently and||
1539|085|S|avoid using mouthwash that contains alcohol, iodine, peroxide, or||
1539|086|S|thyme. Rinse your mouth often with cool water mixed with baking||
1539|087|S|soda or salt. It may also be best to eat soft, moist foods.||
1539|088|S|   Temporary hair loss may occur. Normal hair growth should||
1539|089|S|return after treatment has ended.||
1539|090|S|   People using this medication may have serious side effects.||
1539|091|S|However, you have been prescribed this drug because your doctor||
1539|092|S|has judged that the benefit to you is greater than the risk of||
1539|093|S|side effects. Careful monitoring by your doctor may decrease your||
1539|094|S|risk.||
1539|095|S|   Tell your doctor right away if you have any serious side||
1539|096|S|effects, including: swelling hands/ankles/feet,||
1539|097|S|missed/heavy/painful periods, easy bruising/bleeding, unusual||
1539|098|S|tiredness, mental/mood changes (such as anxiety, aggression),||
1539|099|S|wound problems (such as slowed wound healing).||
1539|100|S|   Everolimus has rarely caused very serious (possibly fatal)||
1539|101|S|kidney problems. Tell your doctor right away if you develop signs||
1539|102|S|of kidney problems, such as a change in the amount of urine.||
1539|103|S|   This medication may rarely make your blood sugar rise, which||
1539|104|S|can cause or worsen diabetes. Tell your doctor right away if you||
1539|105|S|have symptoms of high blood sugar such as increased||
1539|106|S|thirst/urination. If you already have diabetes, check your blood||
1539|107|S|sugar regularly as directed and share the results with your||
1539|108|S|doctor. Your doctor may need to adjust your diabetes medication,||
1539|109|S|exercise program, or diet.||
1539|110|S|   This medication may cause your cholesterol/triglycerides to||
1539|111|S|increase. You may need to have your cholesterol/triglycerides||
1539|112|S|checked periodically and/or take another medication to control||
1539|113|S|your cholesterol/triglycerides.||
1539|114|S|   This medication may lower your ability to fight infections.||
1539|115|S|This may make you more likely to get a serious (rarely fatal)||
1539|116|S|infection or make any infection you have worse. Tell your doctor||
1539|117|S|right away if you have any signs of infection (such as sore||
1539|118|S|throat that doesn't go away, fever, chills).||
1539|119|S|   This medication may make side effects from radiation treatment||
1539|120|S|worse. These side effects can sometimes be severe. Tell your||
1539|121|S|doctor if you have had or are planning to have radiation||
1539|122|S|treatment.||
1539|123|S|   This medication has caused very serious (rarely fatal) lung||
1539|124|S|problems. Get medical help right away if you have symptoms of||
1539|125|S|lung problems, such as shortness of breath, chest pain.||
1539|126|S|   Everolimus may rarely cause serious (possibly fatal) liver||
1539|127|S|disease in people who have hepatitis B virus. Get medical help||
1539|128|S|right away if you have any symptoms of liver damage, including:||
1539|129|S|nausea/vomiting that doesn't stop, loss of appetite, dark urine,||
1539|130|S|stomach/abdominal pain, yellow eyes/skin.||
1539|131|S|   This medication may increase your risk of getting a rare but||
1539|132|S|very serious (sometimes fatal) brain infection (progressive||
1539|133|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1539|134|S|if any of these rare but very serious side effects occur:||
1539|135|S|clumsiness, loss of coordination, weakness, sudden change in your||
1539|136|S|thinking (such as confusion, difficulty concentrating),||
1539|137|S|difficulty moving your muscles, problems with speech,||
1539|138|S|new/worsening seizures, vision changes.||
1539|139|S|   Everolimus can commonly cause a mild rash that is usually not||
1539|140|S|serious. However, you may not be able to tell it apart from a||
1539|141|S|rare rash that could be a sign of a severe allergic reaction. Get||
1539|142|S|medical help right away if you develop any rash.||
1539|143|S|   A very serious allergic reaction to this drug is rare.||
1539|144|S|However, get medical help right away if you notice any symptoms||
1539|145|S|of a serious allergic reaction, including: rash, itching/swelling||
1539|146|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1539|147|S|breathing.||
1539|148|S|   This is not a complete list of possible side effects. If you||
1539|149|S|notice other effects not listed above, contact your doctor or||
1539|150|S|pharmacist.||
1539|151|S|   In the US -||
1539|152|S|   Call your doctor for medical advice about side effects. You||
1539|153|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1539|154|S|www.fda.gov/medwatch.||
1539|155|S|   In Canada - Call your doctor for medical advice about side||
1539|156|S|effects. You may report side effects to Health Canada at||
1539|157|S|1-866-234-2345.||
1539|158|B|||
1539|159|P|PRECAUTIONS:  Before taking everolimus, tell your doctor or||
1539|160|P|pharmacist if you are allergic to it; or to sirolimus or||
1539|161|P|temsirolimus; or if you have any other allergies. This product||
1539|162|P|may contain inactive ingredients, which can cause allergic||
1539|163|P|reactions or other problems. Talk to your pharmacist for more||
1539|164|P|details.||
1539|165|P|   Before using this medication, tell your doctor or pharmacist||
1539|166|P|your medical history, especially of: liver disease, any||
1539|167|P|recent/current infections, diabetes, high||
1539|168|P|cholesterol/triglyceride levels, radiation treatment.||
1539|169|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1539|170|P|can make you more dizzy. Do not drive, use machinery, or do||
1539|171|P|anything that needs alertness until you can do it safely. Limit||
1539|172|P|alcoholic beverages. Talk to your doctor if you are using||
1539|173|P|marijuana (cannabis).||
1539|174|P|   Everolimus can make you more likely to get infections or may||
1539|175|P|make current infections worse. Stay away from anyone who has an||
1539|176|P|infection that may easily spread (such as chickenpox, COVID-19,||
1539|177|P|measles, flu). Talk to your doctor if you have been exposed to an||
1539|178|P|infection or for more details.||
1539|179|P|   Tell your health care professional that you are using||
1539|180|P|everolimus before having any immunizations/vaccinations. Avoid||
1539|181|P|contact with people who have recently received live vaccines||
1539|182|P|(such as flu vaccine inhaled through the nose).||
1539|183|P|   To lower the chance of getting cut, bruised, or injured, use||
1539|184|P|caution with sharp objects like razors and nail cutters, and||
1539|185|P|avoid activities such as contact sports.||
1539|186|P|   Before having surgery, tell your doctor or dentist about all||
1539|187|P|the products you use (including prescription drugs,||
1539|188|P|nonprescription drugs, and herbal products). Your doctor or||
1539|189|P|dentist may tell you to stop taking everolimus at least 1 week||
1539|190|P|before surgery. This medication may cause wounds to heal more||
1539|191|P|slowly. Follow all instructions about when to stop or restart||
1539|192|P|this medication.||
1539|193|P|   Older adults may be more sensitive to the side effects of this||
1539|194|P|drug.||
1539|195|P|   This medication can affect fertility in both males and||
1539|196|P|females. Ask your doctor for more details.||
1539|197|P|   Tell your doctor if you are pregnant or plan to become||
1539|198|P|pregnant. You should not become pregnant while using everolimus.||
1539|199|P|Everolimus may harm an unborn baby. Women using this medication||
1539|200|P|should ask about reliable forms of birth control during treatment||
1539|201|P|and for 8 weeks after the last dose. Men using this medication||
1539|202|P|should ask about reliable forms of birth control during treatment||
1539|203|P|and for 4 weeks after the last dose. If you or your partner||
1539|204|P|becomes pregnant, talk to your doctor right away about the risks||
1539|205|P|and benefits of this medication.||
1539|206|P|   Since this drug can be absorbed through the skin and lungs and||
1539|207|P|may harm an unborn baby, women who are pregnant or who may become||
1539|208|P|pregnant should not handle this medication or breathe the dust||
1539|209|P|from the tablets.||
1539|210|P|   It is unknown if this medication passes into breast milk.||
1539|211|P|Because of the possible risk to the infant, breastfeeding is not||
1539|212|P|recommended while using this medication and for 2 weeks after the||
1539|213|P|last dose. Consult your doctor before breastfeeding.||
1539|214|B|||
1539|215|I|DRUG INTERACTIONS:  See also How to Use section.||
1539|216|I|   Drug interactions may change how your medications work or||
1539|217|I|increase your risk for serious side effects. This document does||
1539|218|I|not contain all possible drug interactions. Keep a list of all||
1539|219|I|the products you use (including prescription/nonprescription||
1539|220|I|drugs and herbal products) and share it with your doctor and||
1539|221|I|pharmacist. Do not start, stop, or change the dosage of any||
1539|222|I|medicines without your doctor's approval.||
1539|223|I|   Some products that may interact with this drug include: other||
1539|224|I|drugs that weaken the immune system/increase the risk of||
1539|225|I|infection (such as natalizumab, rituximab), ACE inhibitors (such||
1539|226|I|as captopril, lisinopril).||
1539|227|I|   Other medications can affect the removal of everolimus from||
1539|228|I|your body, which may affect how everolimus works. Examples||
1539|229|I|include azole antifungals (such as itraconazole, ketoconazole),||
1539|230|I|cobicistat, macrolide antibiotics (such as clarithromycin,||
1539|231|I|erythromycin), nefazodone, HIV protease inhibitors (such as||
1539|232|I|atazanavir), ritonavir, St. John's wort, telithromycin, among||
1539|233|I|others.||
1539|234|B|||
1539|235|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1539|236|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1539|237|O|poison control center right away. US residents can call||
1539|238|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1539|239|B|||
1539|240|N|NOTES:  Do not share this medication with others.||
1539|241|N|   Lab and/or medical tests (such as blood sugar,||
1539|242|N|cholesterol/triglyceride levels, complete blood count, kidney||
1539|243|N|function, everolimus trough levels) will be done before you start||
1539|244|N|taking this medication and while you are taking it. Keep all||
1539|245|N|medical and lab appointments. Consult your doctor for more||
1539|246|N|details.||
1539|247|B|||
1539|248|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1539|249|D|remember. If it is more than 6 hours after the missed dose, skip||
1539|250|D|the missed dose. Take your next dose at the regular time. Do not||
1539|251|D|double the dose to catch up.||
1539|252|B|||
1539|253|R|STORAGE:  Store in the original container at room temperature||
1539|254|R|away from light and moisture. Do not store in the bathroom. Keep||
1539|255|R|all medications away from children and pets.||
1539|256|R|   Do not flush medications down the toilet or pour them into a||
1539|257|R|drain unless instructed to do so. Properly discard this product||
1539|258|R|when it is expired or no longer needed. Consult your pharmacist||
1539|259|R|or local waste disposal company.||
1539|260|B|||
1539|261|M|MEDICAL ALERT:  Your condition can cause complications in a||
1539|262|M|medical emergency. For information about enrolling in MedicAlert,||
1539|263|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1539|264|B|||
1539|265|A|Information last revised April 2025.||
1539|266|A|Copyright(c) 2025 First Databank, Inc.||
1539|267|B|||
1541|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1541|002|Z|does NOT have all possible information about this product. This||
1541|003|Z|information does not assure that this product is safe, effective,||
1541|004|Z|or appropriate for you. This information is not individual||
1541|005|Z|medical advice and does not substitute for the advice of your||
1541|006|Z|health care professional. Always ask your health care||
1541|007|Z|professional for complete information about this product and your||
1541|008|Z|specific health needs.||
1541|009|B|||
1541|010|T|BENZYDAMINE RINSE - ORAL||
1541|011|F|(ben-ZID-a-meen)||
1541|012|B|||
1541|013|U|USES:  Benzydamine is used to relieve pain and swelling from||
1541|014|U|sores in the mouth and throat (mucositis) caused by radiation||
1541|015|U|treatment. It can also be used to treat pain from a sore throat.||
1541|016|U|It works by blocking certain natural substances in your body to||
1541|017|U|reduce pain and swelling. Benzydamine belongs to a class of drugs||
1541|018|U|known as nonsteroidal anti-inflammatory drugs (NSAIDs).||
1541|019|B|||
1541|020|H|HOW TO USE:  If you are using this medication to treat mouth||
1541|021|H|sores, rinse your mouth as directed by your doctor, usually 3 to||
1541|022|H|4 times a day. Swish the solution in your mouth for at least 30||
1541|023|H|seconds, and then spit it out. Do not swallow the liquid. Your||
1541|024|H|doctor may direct you to start using this medication the day||
1541|025|H|before you begin radiation treatment and to continue to use it||
1541|026|H|even after you have finished radiation treatment.||
1541|027|H|   If you are using this medication to treat pain from a sore||
1541|028|H|throat, use as directed by your doctor, usually every||
1541|029|H|one-and-a-half to three hours. Gargle for 30 seconds, and then||
1541|030|H|spit it out. Do not swallow the liquid.||
1541|031|H|   If a burning feeling in the mouth occurs, you may mix an equal||
1541|032|H|amount of lukewarm water with this medication to reduce this side||
1541|033|H|effect.||
1541|034|H|   The dosage is based on your medical condition and response to||
1541|035|H|treatment.||
1541|036|H|   Use this medication regularly to get the most benefit from it.||
1541|037|H|To help you remember, use it at the same times each day.||
1541|038|H|   Tell your doctor if your condition lasts or gets worse.||
1541|039|B|||
1541|040|S|SIDE EFFECTS:  Numbness, stinging, burning feeling in the mouth||
1541|041|S|may occur. Mixing this medication with lukewarm water may reduce||
1541|042|S|the burning feeling in the mouth. If any of these effects last or||
1541|043|S|get worse, tell your doctor or pharmacist promptly.||
1541|044|S|   Remember that this medication has been prescribed because your||
1541|045|S|doctor has judged that the benefit to you is greater than the||
1541|046|S|risk of side effects. Many people using this medication do not||
1541|047|S|have serious side effects.||
1541|048|S|   A very serious allergic reaction to this drug is rare.||
1541|049|S|However, get medical help right away if you notice any symptoms||
1541|050|S|of a serious allergic reaction, including: rash, itching/swelling||
1541|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1541|052|S|breathing.||
1541|053|S|   This is not a complete list of possible side effects. If you||
1541|054|S|notice other effects not listed above, contact your doctor or||
1541|055|S|pharmacist.||
1541|056|S|   In the US -||
1541|057|S|   Call your doctor for medical advice about side effects. You||
1541|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1541|059|S|www.fda.gov/medwatch.||
1541|060|S|   In Canada - Call your doctor for medical advice about side||
1541|061|S|effects. You may report side effects to Health Canada at||
1541|062|S|1-866-234-2345.||
1541|063|B|||
1541|064|P|PRECAUTIONS:  Before using benzydamine, tell your doctor or||
1541|065|P|pharmacist if you are allergic to it; or if you have any other||
1541|066|P|allergies. This product may contain inactive ingredients, which||
1541|067|P|can cause allergic reactions or other problems. Talk to your||
1541|068|P|pharmacist for more details.||
1541|069|P|   Before using this medication, tell your doctor or pharmacist||
1541|070|P|your medical history.||
1541|071|P|   Before having surgery, tell your doctor or dentist about all||
1541|072|P|the products you use (including prescription drugs,||
1541|073|P|nonprescription drugs, and herbal products).||
1541|074|P|   During pregnancy, this medication should be used only when||
1541|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
1541|076|P|   It is unknown if this medication passes into breast milk.||
1541|077|P|Consult your doctor before breastfeeding.||
1541|078|B|||
1541|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1541|080|I|medications work or increase your risk for serious side effects.||
1541|081|I|This document does not contain all possible drug interactions.||
1541|082|I|Keep a list of all the products you use (including||
1541|083|I|prescription/nonprescription drugs and herbal products) and share||
1541|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
1541|085|I|the dosage of any medicines without your doctor's approval.||
1541|086|B|||
1541|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1541|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1541|089|O|poison control center right away. US residents can call||
1541|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1541|091|B|||
1541|092|N|NOTES:  Do not share this medication with others.||
1541|093|B|||
1541|094|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1541|095|D|If it is near the time of the next dose, skip the missed dose.||
1541|096|D|Use your next dose at the regular time. Do not double the dose to||
1541|097|D|catch up.||
1541|098|B|||
1541|099|R|STORAGE:  Store at room temperature away from light and moisture.||
1541|100|R|Do not store in the bathroom. Keep all medications away from||
1541|101|R|children and pets.||
1541|102|R|   Do not flush medications down the toilet or pour them into a||
1541|103|R|drain unless instructed to do so. Properly discard this product||
1541|104|R|when it is expired or no longer needed. Consult your pharmacist||
1541|105|R|or local waste disposal company.||
1541|106|B|||
1541|107|A|Information last revised May 2024.||
1541|108|A|Copyright(c) 2025 First Databank, Inc.||
1541|109|B|||
1542|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1542|002|Z|does NOT have all possible information about this product. This||
1542|003|Z|information does not assure that this product is safe, effective,||
1542|004|Z|or appropriate for you. This information is not individual||
1542|005|Z|medical advice and does not substitute for the advice of your||
1542|006|Z|health care professional. Always ask your health care||
1542|007|Z|professional for complete information about this product and your||
1542|008|Z|specific health needs.||
1542|009|B|||
1542|010|T|CYSTEAMINE DELAYED-RELEASE CAPSULE - ORAL||
1542|011|F|(sis-TEE-a-meen)||
1542|012|B|||
1542|013|C|COMMON BRAND NAME(S): Procysbi||
1542|014|B|||
1542|015|U|USES:  This medication is used to help preserve kidney function||
1542|016|U|and manage kidney damage and other problems in people with an||
1542|017|U|inherited disorder that causes build-up of a certain natural||
1542|018|U|substance (cystine) in the body (nephropathic cystinosis).||
1542|019|U|Cystine build-up can cause problems such as kidney problems, slow||
1542|020|U|growth, weak bones, and eye problems. Cysteamine helps the body||
1542|021|U|get rid of cystine.||
1542|022|B|||
1542|023|H|HOW TO USE:  Read the Patient Information Leaflet and||
1542|024|H|Instructions for Use if available from your pharmacist before you||
1542|025|H|start using cysteamine and each time you get a refill. If you||
1542|026|H|have any questions, ask your doctor or pharmacist.||
1542|027|H|   Take this medication by mouth as directed by your doctor,||
1542|028|H|usually twice a day (every 12 hours).||
1542|029|H|   Taking this medication with food can affect its absorption.||
1542|030|H|Take this medication on an empty stomach, at least 2 hours after||
1542|031|H|and at least 30 minutes before eating food. If you cannot take it||
1542|032|H|without eating, you can eat a small amount of food (4 ounces or||
1542|033|H|1/2 cup) between 1 hour before and 1 hour after taking this||
1542|034|H|medication. Choose one way to take this medication (either||
1542|035|H|without eating or with a small amount of food) and take it the||
1542|036|H|same way with every dose. Avoid high-fat food close to the time||
1542|037|H|you take your cysteamine dose.||
1542|038|H|   Swallow the capsules whole with fruit juice (except for||
1542|039|H|grapefruit juice) or water. Do not crush or chew this medication||
1542|040|H|or the contents of the capsules. Do not drink alcohol while you||
1542|041|H|are on treatment with this drug. Drinking alcohol may increase||
1542|042|H|the amount of this medication in your body which may cause||
1542|043|H|serious side effects.||
1542|044|H|   If you cannot swallow the capsule whole, you can open the||
1542|045|H|capsule and sprinkle the contents on 4 ounces (1/2 cup) of||
1542|046|H|applesauce or berry jelly and eat the mixture within 30 minutes||
1542|047|H|of preparing it. Or you can sprinkle the contents into 4 ounces||
1542|048|H|(1/2 cup) of fruit juice (except for grapefruit juice), stir the||
1542|049|H|mixture gently until mixed, and drink it within 30 minutes. Do||
1542|050|H|not crush or chew the mixture or save it for later use.||
1542|051|H|   The dosage is based on your weight, medical condition, and||
1542|052|H|response to treatment. To reduce your risk of side effects, your||
1542|053|H|doctor may direct you to start this medication at a low dose and||
1542|054|H|gradually increase your dose. Follow your doctor's instructions||
1542|055|H|carefully.||
1542|056|H|   Take this medication regularly to get the most benefit from||
1542|057|H|it. To help you remember, take it at the same times each day.||
1542|058|B|||
1542|059|S|SIDE EFFECTS:  Nausea, vomiting, stomach/abdominal pain, fever,||
1542|060|S|loss of appetite, breath/skin odor, tiredness, drowsiness,||
1542|061|S|dizziness, and diarrhea may occur. If any of these effects last||
1542|062|S|or get worse, tell your doctor or pharmacist promptly.||
1542|063|S|   Remember that this medication has been prescribed because your||
1542|064|S|doctor has judged that the benefit to you is greater than the||
1542|065|S|risk of side effects. Many people using this medication do not||
1542|066|S|have serious side effects.||
1542|067|S|   Tell your doctor right away if you have any serious side||
1542|068|S|effects, including: mental/mood changes (such as confusion,||
1542|069|S|depression, lack of concentration), deep sleep, unusual||
1542|070|S|tiredness, headache, hearing problems (such as buzzing/ringing in||
1542|071|S|the ears), eye/vision problems (such as blurred vision, loss of||
1542|072|S|vision, eye pain), skin problems (such as thinning of the skin,||
1542|073|S|fragile skin, stretch marks, easy bruising), bone problems (such||
1542|074|S|as bone/joint/back pain, leg pain, broken bones, overly flexible||
1542|075|S|joints).||
1542|076|S|   Get medical help right away if you have any very serious side||
1542|077|S|effects, including: seizures, severe/bloody diarrhea, signs of||
1542|078|S|bleeding or ulcers in the stomach/intestines (such as||
1542|079|S|black/bloody stools, severe stomach/abdominal pain, vomit that||
1542|080|S|looks like coffee grounds).||
1542|081|S|   Cysteamine can commonly cause a rash that is usually not||
1542|082|S|serious. However, you may not be able to tell it apart from a||
1542|083|S|rare rash that could be a sign of a severe reaction. Get medical||
1542|084|S|help right away if you develop any rash.||
1542|085|S|   A very serious allergic reaction to this drug is rare.||
1542|086|S|However, get medical help right away if you notice any symptoms||
1542|087|S|of a serious allergic reaction, including: rash, itching/swelling||
1542|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1542|089|S|breathing.||
1542|090|S|   This is not a complete list of possible side effects. If you||
1542|091|S|notice other effects not listed above, contact your doctor or||
1542|092|S|pharmacist.||
1542|093|S|   In the US -||
1542|094|S|   Call your doctor for medical advice about side effects. You||
1542|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1542|096|S|www.fda.gov/medwatch.||
1542|097|S|   In Canada - Call your doctor for medical advice about side||
1542|098|S|effects. You may report side effects to Health Canada at||
1542|099|S|1-866-234-2345.||
1542|100|B|||
1542|101|P|PRECAUTIONS:  Before taking cysteamine, tell your doctor or||
1542|102|P|pharmacist if you are allergic to it; or to penicillamine; or if||
1542|103|P|you have any other allergies. This product may contain inactive||
1542|104|P|ingredients, which can cause allergic reactions or other||
1542|105|P|problems. Talk to your pharmacist for more details.||
1542|106|P|   Before using this medication, tell your doctor or pharmacist||
1542|107|P|your or your child's medical history, especially of: liver||
1542|108|P|disease, stomach/intestine problems (such as bleeding, ulcers),||
1542|109|P|low white blood cell count.||
1542|110|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1542|111|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1542|112|P|machinery, or do anything that needs alertness until you can do||
1542|113|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1542|114|P|are using marijuana (cannabis).||
1542|115|P|   Before having surgery, tell your doctor or dentist about all||
1542|116|P|the products you use (including prescription drugs,||
1542|117|P|nonprescription drugs, and herbal products).||
1542|118|P|   During pregnancy, this medication should be used only when||
1542|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
1542|120|P|   It is unknown if this medication passes into breast milk.||
1542|121|P|Consult your doctor before breastfeeding.||
1542|122|B|||
1542|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1542|124|I|medications work or increase your risk for serious side effects.||
1542|125|I|This document does not contain all possible drug interactions.||
1542|126|I|Keep a list of all the products you use (including||
1542|127|I|prescription/nonprescription drugs and herbal products) and share||
1542|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
1542|129|I|the dosage of any medicines without your doctor's approval.||
1542|130|I|   Products that contain bicarbonate or carbonate may decrease||
1542|131|I|the effect of this medication if taken at the same time. If you||
1542|132|I|are also taking a product that contains bicarbonate or carbonate,||
1542|133|I|separate the time that you take a dose by at least one hour||
1542|134|I|before or after the time that you take cysteamine||
1542|135|I|delayed-release.||
1542|136|B|||
1542|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1542|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1542|139|O|poison control center right away. US residents can call||
1542|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1542|141|B|||
1542|142|N|NOTES:  Do not share this medication with others.||
1542|143|N|   Lab and/or medical tests (such as cystine or cysteamine||
1542|144|N|levels, complete blood count, kidney/liver function) should be||
1542|145|N|done while you are taking this medication. Keep all medical and||
1542|146|N|lab appointments. Consult your doctor for more details.||
1542|147|B|||
1542|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1542|149|D|remember. If it is less than 4 hours before the next dose, skip||
1542|150|D|the missed dose. Take your next dose at the regular time. Do not||
1542|151|D|double the dose to catch up.||
1542|152|B|||
1542|153|R|STORAGE:  Store in the original container at room temperature||
1542|154|R|away from light and moisture. Do not store in the bathroom. Keep||
1542|155|R|the drying agent (desiccant) in the container. Tightly close the||
1542|156|R|container when not in use. Keep all medications away from||
1542|157|R|children and pets.||
1542|158|R|   Do not flush medications down the toilet or pour them into a||
1542|159|R|drain unless instructed to do so. Properly discard this product||
1542|160|R|when it is expired or no longer needed. Consult your pharmacist||
1542|161|R|or local waste disposal company.||
1542|162|B|||
1542|163|A|Information last revised July 2024.||
1542|164|A|Copyright(c) 2025 First Databank, Inc.||
1542|165|B|||
1543|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1543|002|Z|does NOT have all possible information about this product. This||
1543|003|Z|information does not assure that this product is safe, effective,||
1543|004|Z|or appropriate for you. This information is not individual||
1543|005|Z|medical advice and does not substitute for the advice of your||
1543|006|Z|health care professional. Always ask your health care||
1543|007|Z|professional for complete information about this product and your||
1543|008|Z|specific health needs.||
1543|009|B|||
1543|010|T|SAXAGLIPTIN/METFORMIN - ORAL||
1543|011|F|(SAX-a-GLIP-tin/met-FOR-min)||
1543|012|B|||
1543|013|W|WARNING:  Rarely, too much metformin can build up in the body and||
1543|014|W|cause a serious (sometimes fatal) condition called lactic||
1543|015|W|acidosis. Lactic acidosis is more likely if you are an older||
1543|016|W|adult, if you have kidney or liver disease, dehydration, heart||
1543|017|W|failure, heavy alcohol use, if you have surgery, if you have||
1543|018|W|X-ray or scanning procedures that use iodinated contrast, or if||
1543|019|W|you are using certain drugs. For some conditions, your doctor may||
1543|020|W|tell you to stop taking this medication for a short time. Ask||
1543|021|W|your doctor or pharmacist for more details.||
1543|022|W|   Stop taking this medication and get medical help right away if||
1543|023|W|you have any symptoms of lactic acidosis, such as unusual||
1543|024|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1543|025|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1543|026|W|or stomach pain with nausea/vomiting/diarrhea.||
1543|027|B|||
1543|028|U|USES:  This combination medication is used with a proper diet and||
1543|029|U|exercise program to control high blood sugar in people with type||
1543|030|U|2 diabetes. Controlling high blood sugar helps prevent kidney||
1543|031|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1543|032|U|function problems. Proper control of diabetes may also lessen||
1543|033|U|your risk of a heart attack or stroke.||
1543|034|U|   This product contains 2 medications. Saxagliptin works by||
1543|035|U|increasing levels of natural substances called incretins.||
1543|036|U|Incretins help to control blood sugar by increasing insulin||
1543|037|U|release, especially after a meal. They also decrease the amount||
1543|038|U|of sugar your liver makes. Metformin works by helping to restore||
1543|039|U|your body's proper response to the insulin you naturally produce.||
1543|040|U|It also decreases the amount of sugar that your liver makes and||
1543|041|U|that your stomach/intestines absorb.||
1543|042|B|||
1543|043|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1543|044|H|from your pharmacist before you start taking||
1543|045|H|saxagliptin/metformin and each time you get a refill. If you have||
1543|046|H|any questions, ask your doctor or pharmacist.||
1543|047|H|   Take this medication by mouth with food as directed by your||
1543|048|H|doctor, usually twice daily with meals. The dosage is based on||
1543|049|H|your medical condition, response to treatment, and other||
1543|050|H|medications you may be taking. Be sure to tell your doctor and||
1543|051|H|pharmacist about all the products you use (including prescription||
1543|052|H|drugs, nonprescription drugs, and herbal products).||
1543|053|H|   To reduce your risk of side effects, your doctor may direct||
1543|054|H|you to start this medication at a low dose and gradually increase||
1543|055|H|your dose. Your doctor will adjust your dose based on your blood||
1543|056|H|sugar to find the best dose for you. Follow your doctor's||
1543|057|H|instructions carefully.||
1543|058|H|   If you are already taking another diabetes drug (such as||
1543|059|H|pioglitazone), follow your doctor's directions carefully for||
1543|060|H|stopping/continuing the old drug and starting this medication.||
1543|061|H|Carefully follow the medication treatment plan, meal plan, and||
1543|062|H|exercise program your doctor has recommended.||
1543|063|H|   Use this medication regularly to get the most benefit from it.||
1543|064|H|To help you remember, take it at the same times each day.||
1543|065|H|   Tell your doctor if your condition does not get better or if||
1543|066|H|it gets worse (your blood sugar is too high or too low).||
1543|067|B|||
1543|068|S|SIDE EFFECTS:  See also Warning section.||
1543|069|S|   Nausea, vomiting, stomach upset, diarrhea, headache, and a||
1543|070|S|metallic taste in the mouth may occur. If any of these effects||
1543|071|S|last or get worse, tell your doctor or pharmacist promptly. If||
1543|072|S|stomach symptoms return later (after taking the same dose for||
1543|073|S|several days or weeks), tell your doctor right away. Stomach||
1543|074|S|symptoms that occur after the first days of your treatment may be||
1543|075|S|signs of lactic acidosis.||
1543|076|S|   Remember that this medication has been prescribed because your||
1543|077|S|doctor has judged that the benefit to you is greater than the||
1543|078|S|risk of side effects. Many people using this medication do not||
1543|079|S|have serious side effects.||
1543|080|S|   Tell your doctor right away if you have any serious side||
1543|081|S|effects, including: joint pain, unusual skin blisters, signs of||
1543|082|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1543|083|S|unusual tiredness, unusual/sudden weight gain).||
1543|084|S|   This medication does not usually cause low blood sugar||
1543|085|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1543|086|S|prescribed with other diabetes medications, or if you do not get||
1543|087|S|enough calories from food, or if you do unusually heavy exercise.||
1543|088|S|Talk with your doctor or pharmacist about whether the dose of||
1543|089|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1543|090|S|of low blood sugar include sudden sweating, shaking, fast||
1543|091|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1543|092|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1543|093|S|treat low blood sugar. If you don't have these reliable forms of||
1543|094|S|glucose, rapidly raise your blood sugar by eating a quick source||
1543|095|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1543|096|S|juice or non-diet soda. Tell your doctor right away about the||
1543|097|S|reaction and the use of this product. To help prevent low blood||
1543|098|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1543|099|S|Check with your doctor or pharmacist to find out what you should||
1543|100|S|do if you miss a meal.||
1543|101|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1543|102|S|thirst/urination. If these symptoms occur, tell your doctor right||
1543|103|S|away. Your doctor may need to adjust your diabetes medication,||
1543|104|S|exercise program, or diet.||
1543|105|S|   Get medical help right away if you have any very serious side||
1543|106|S|effects, including: signs of disease of the pancreas (such as||
1543|107|S|severe stomach/abdominal pain which may spread to the back,||
1543|108|S|nausea/vomiting that doesn't stop).||
1543|109|S|   A very serious allergic reaction to this drug is rare.||
1543|110|S|However, get medical help right away if you notice any symptoms||
1543|111|S|of a serious allergic reaction, including: rash, itching/swelling||
1543|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1543|113|S|breathing.||
1543|114|S|   This is not a complete list of possible side effects. If you||
1543|115|S|notice other effects not listed above, contact your doctor or||
1543|116|S|pharmacist.||
1543|117|S|   In the US -||
1543|118|S|   Call your doctor for medical advice about side effects. You||
1543|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1543|120|S|www.fda.gov/medwatch.||
1543|121|S|   In Canada - Call your doctor for medical advice about side||
1543|122|S|effects. You may report side effects to Health Canada at||
1543|123|S|1-866-234-2345.||
1543|124|B|||
1543|125|P|PRECAUTIONS:  See also Warning section.||
1543|126|P|   Before taking this medication, tell your doctor or pharmacist||
1543|127|P|if you are allergic to saxagliptin or metformin; or if you have||
1543|128|P|any other allergies. This product may contain inactive||
1543|129|P|ingredients, which can cause allergic reactions or other||
1543|130|P|problems. Talk to your pharmacist for more details.||
1543|131|P|   Before using this medication, tell your doctor or pharmacist||
1543|132|P|your medical history, especially of: kidney disease, severe||
1543|133|P|breathing problems (such as obstructive lung disease, severe||
1543|134|P|asthma), blood problems (such as anemia, vitamin B12 deficiency),||
1543|135|P|liver disease, disease of the pancreas (pancreatitis), risk||
1543|136|P|factors for pancreatitis (such as gallstones, regular use/abuse||
1543|137|P|of alcohol, high levels of fats/triglycerides in the blood).||
1543|138|P|   You may experience blurred vision, dizziness, or drowsiness||
1543|139|P|due to extremely low or high blood sugar. Do not drive, use||
1543|140|P|machinery, or do anything that needs alertness or clear vision||
1543|141|P|until you can do it safely.||
1543|142|P|   Limit alcohol while taking this medication because it can||
1543|143|P|increase your risk of developing low blood sugar.||
1543|144|P|   Before having surgery or any X-ray/scanning procedure using||
1543|145|P|iodinated contrast, tell your doctor or dentist about all the||
1543|146|P|products you use (including prescription drugs, nonprescription||
1543|147|P|drugs, and herbal products). You may need to stop this medication||
1543|148|P|for a short time for the surgery/procedure. Ask your doctor or||
1543|149|P|dentist for instructions before your surgery/procedure.||
1543|150|P|   High fever, "water pills" (diuretics such as||
1543|151|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1543|152|P|may cause dehydration and increase your risk of lactic acidosis.||
1543|153|P|Stop taking this medication and tell your doctor right away if||
1543|154|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1543|155|P|fluids to prevent dehydration unless your doctor directs you||
1543|156|P|otherwise.||
1543|157|P|   It may be harder to control your blood sugar when your body is||
1543|158|P|stressed (such as due to fever, infection, injury, or surgery).||
1543|159|P|Consult your doctor because this may require a change in your||
1543|160|P|treatment plan, medications, or blood sugar testing.||
1543|161|P|   Older adults may be more sensitive to the side effects of this||
1543|162|P|drug, especially low blood sugar and lactic acidosis.||
1543|163|P|   During pregnancy, this medication should be used only when||
1543|164|P|clearly needed. Discuss the risks and benefits with your doctor.||
1543|165|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1543|166|P|your doctor for managing your blood sugar while pregnant. Your||
1543|167|P|doctor may change your diabetes treatment during your pregnancy||
1543|168|P|(such as diet and medications including insulin).||
1543|169|P|   Metformin can cause changes in the menstrual cycle (promote||
1543|170|P|ovulation) and increase the risk of becoming pregnant. Consult||
1543|171|P|your doctor or pharmacist about the use of reliable birth control||
1543|172|P|while using this medication.||
1543|173|P|   Metformin passes into breast milk in small amounts. It is||
1543|174|P|unknown if saxagliptin passes into breast milk. Consult your||
1543|175|P|doctor before breastfeeding.||
1543|176|B|||
1543|177|I|DRUG INTERACTIONS:  See also Precautions section.||
1543|178|I|   Drug interactions may change how your medications work or||
1543|179|I|increase your risk for serious side effects. This document does||
1543|180|I|not contain all possible drug interactions. Keep a list of all||
1543|181|I|the products you use (including prescription/nonprescription||
1543|182|I|drugs and herbal products) and share it with your doctor and||
1543|183|I|pharmacist. Do not start, stop, or change the dosage of any||
1543|184|I|medicines without your doctor's approval.||
1543|185|I|   Other medications can affect the removal of saxagliptin from||
1543|186|I|your body, which may affect how saxagliptin works. Examples||
1543|187|I|include azole antifungals (such as itraconazole, ketoconazole),||
1543|188|I|nefazodone, telithromycin, ritonavir, among others.||
1543|189|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1543|190|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1543|191|I|heartbeat you would usually feel when your blood sugar falls too||
1543|192|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1543|193|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1543|194|I|   Many drugs can affect your blood sugar, making it harder to||
1543|195|I|control. Before you start, stop, or change any medication, talk||
1543|196|I|with your doctor or pharmacist about how the medication may||
1543|197|I|affect your blood sugar. Check your blood sugar regularly as||
1543|198|I|directed and share the results with your doctor. Tell your doctor||
1543|199|I|right away if you have symptoms of high or low blood sugar. (See||
1543|200|I|also Side Effects section.) Your doctor may need to adjust your||
1543|201|I|diabetes medication, exercise program, or diet.||
1543|202|B|||
1543|203|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1543|204|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1543|205|O|poison control center right away. US residents can call||
1543|206|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1543|207|O|Symptoms of overdose may include: severe drowsiness, severe||
1543|208|O|nausea/vomiting/diarrhea, rapid breathing, slow/irregular||
1543|209|O|heartbeat.||
1543|210|B|||
1543|211|N|NOTES:  Do not share this medication with others.||
1543|212|N|   Attend a diabetes education program to learn more about how to||
1543|213|N|manage your diabetes with medications, diet, exercise, and||
1543|214|N|regular medical exams.||
1543|215|N|   Learn the symptoms of high and low blood sugar and how to||
1543|216|N|treat low blood sugar. Check your blood sugar regularly as||
1543|217|N|directed.||
1543|218|N|   Lab and/or medical tests (such as kidney function, liver||
1543|219|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
1543|220|N|should be done before you start taking this medication and while||
1543|221|N|you are taking it. Keep all medical and lab appointments. Consult||
1543|222|N|your doctor for more details.||
1543|223|B|||
1543|224|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1543|225|D|remember. If it is near the time of the next dose, skip the||
1543|226|D|missed dose. Take your next dose at the regular time. Do not||
1543|227|D|double the dose to catch up.||
1543|228|B|||
1543|229|R|STORAGE:  Store at room temperature away from light and moisture.||
1543|230|R|Do not store in the bathroom. Keep all medications away from||
1543|231|R|children and pets.||
1543|232|R|   Do not flush medications down the toilet or pour them into a||
1543|233|R|drain unless instructed to do so. Properly discard this product||
1543|234|R|when it is expired or no longer needed. Consult your pharmacist||
1543|235|R|or local waste disposal company.||
1543|236|B|||
1543|237|M|MEDICAL ALERT:  Your condition can cause complications in a||
1543|238|M|medical emergency. For information about enrolling in MedicAlert,||
1543|239|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1543|240|B|||
1543|241|A|Information last revised May 2025.||
1543|242|A|Copyright(c) 2025 First Databank, Inc.||
1543|243|B|||
1546|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1546|002|Z|does NOT have all possible information about this product. This||
1546|003|Z|information does not assure that this product is safe, effective,||
1546|004|Z|or appropriate for you. This information is not individual||
1546|005|Z|medical advice and does not substitute for the advice of your||
1546|006|Z|health care professional. Always ask your health care||
1546|007|Z|professional for complete information about this product and your||
1546|008|Z|specific health needs.||
1546|009|B|||
1546|010|T|DABRAFENIB - ORAL||
1546|011|F|(da-BRAF-e-nib)||
1546|012|B|||
1546|013|C|COMMON BRAND NAME(S): Tafinlar||
1546|014|B|||
1546|015|U|USES:  Dabrafenib is used to treat various cancers (such as skin,||
1546|016|U|thyroid, lung, solid tumors, brain). It belongs to a class of||
1546|017|U|drugs known as kinase inhibitors. Dabrafenib works by slowing or||
1546|018|U|stopping the growth of cancer cells.||
1546|019|B|||
1546|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1546|021|H|pharmacist before you start taking dabrafenib and each time you||
1546|022|H|get a refill. If you have any questions, ask your doctor or||
1546|023|H|pharmacist.||
1546|024|H|   Take this medication by mouth as directed by your doctor,||
1546|025|H|usually twice daily (about 12 hours apart). Take this medication||
1546|026|H|on an empty stomach, at least 1 hour before or 2 hours after||
1546|027|H|meals. If you vomit, do not take another dose to catch up. Take||
1546|028|H|your next dose at the regular time.||
1546|029|H|   If you are using the capsules, swallow the capsules whole. Do||
1546|030|H|not open, crush, chew, or break the capsules.||
1546|031|H|   If you are using the tablet form of this medication, read the||
1546|032|H|Instructions for Use before you start taking dabrafenib and each||
1546|033|H|time you get a refill. Do not swallow whole, chew or crush the||
1546|034|H|tablets. The tablet(s) must be mixed in water before taking. Ask||
1546|035|H|your doctor or pharmacist how much water you should use to mix||
1546|036|H|the tablet(s). Add water and the prescribed number of tablet(s)||
1546|037|H|to the dosing cup provided. Gently stir with the handle of a||
1546|038|H|teaspoon for at least 3 minutes until the tablet(s) break apart.||
1546|039|H|The mixture should be cloudy white and may contain small pieces.||
1546|040|H|Drink all of the mixture right away. To make sure you have taken||
1546|041|H|all of the medication, add more water to the cup, stir with the||
1546|042|H|handle of a teaspoon, and drink it right away. Repeat if any||
1546|043|H|medicine remains in the cup. Take this medication within 30||
1546|044|H|minutes of mixing.||
1546|045|H|   The mixture may also be given through a tube into the stomach||
1546|046|H|(nasogastric or gastric tube). If you are giving this medication||
1546|047|H|through a nasogastric or gastric tube, ask your health care||
1546|048|H|professional for detailed instructions on how to give it.||
1546|049|H|   The dosage is based on your medical condition and response to||
1546|050|H|treatment. Children's dosage is also based on weight.||
1546|051|H|   Do not increase your dose or use this drug more often or for||
1546|052|H|longer than prescribed. Your condition will not improve any||
1546|053|H|faster, and your risk of serious side effects will increase.||
1546|054|H|Since this drug can be absorbed through the skin and lungs and||
1546|055|H|may harm an unborn baby, women who are pregnant or who may become||
1546|056|H|pregnant should not handle this medication or breathe the dust||
1546|057|H|from the capsules.||
1546|058|B|||
1546|059|S|SIDE EFFECTS:  Hair loss, thickening of the outer layers of the||
1546|060|S|skin, headache, swelling/peeling of feet/hands, and||
1546|061|S|joint/muscle/back pain may occur. Weight gain may also occur in||
1546|062|S|children. If any of these effects last or get worse, tell your||
1546|063|S|doctor or pharmacist promptly.||
1546|064|S|   People using this medication may have serious side effects.||
1546|065|S|However, your doctor has prescribed this drug because he or she||
1546|066|S|has judged that the benefit to you is greater than the risk of||
1546|067|S|side effects. Careful monitoring by your doctor may decrease your||
1546|068|S|risk.||
1546|069|S|   Although this medication is used to treat certain skin||
1546|070|S|cancers, it may rarely cause new skin cancer or other cancers.||
1546|071|S|Tell your doctor right away if you notice unusual skin changes||
1546|072|S|(such as skin sores/lumps, warts, change in the size/color of a||
1546|073|S|mole, skin bump that bleeds or does not heal). Your doctor should||
1546|074|S|check your skin before starting treatment, every 2 months during||
1546|075|S|treatment, and for up to 6 months after stopping this medication.||
1546|076|S|   This medication may rarely make your blood sugar rise, which||
1546|077|S|can cause or worsen diabetes. Tell your doctor right away if you||
1546|078|S|have symptoms of high blood sugar such as increased||
1546|079|S|thirst/urination. If you already have diabetes, check your blood||
1546|080|S|sugar regularly as directed and share the results with your||
1546|081|S|doctor. Your doctor may need to adjust your diabetes medication,||
1546|082|S|exercise program, or diet.||
1546|083|S|   Tell your doctor right away if you have any serious side||
1546|084|S|effects, including: easy bruising/bleeding, signs of heart||
1546|085|S|failure (such as shortness of breath, swelling ankles/feet,||
1546|086|S|unusual tiredness, unusual/sudden weight gain),||
1546|087|S|dizziness/fainting, signs of kidney problems (such as change in||
1546|088|S|the amount of urine).||
1546|089|S|   Get medical help right away if you have any very serious side||
1546|090|S|effects, including: eye pain/swelling/redness, vision changes||
1546|091|S|(such as blurred vision, sensitivity to light), fast/irregular||
1546|092|S|heartbeat, signs of bleeding in the brain (such as severe||
1546|093|S|headache, weakness on one side of the body, vision problems,||
1546|094|S|trouble speaking, seizures, or confusion), signs of||
1546|095|S|stomach/intestinal bleeding (such as black/bloody stools, vomit||
1546|096|S|that contains blood or looks like coffee grounds, or dizziness).||
1546|097|S|   Dabrafenib can commonly cause a rash that is usually not||
1546|098|S|serious. However, you may not be able to tell it apart from a||
1546|099|S|rash that could be a sign of a severe reaction. Get medical help||
1546|100|S|right away if you develop any rash.||
1546|101|S|   A very serious allergic reaction to this drug is rare.||
1546|102|S|However, get medical help right away if you notice any symptoms||
1546|103|S|of a serious allergic reaction, including: fever, swollen lymph||
1546|104|S|nodes, rash, itching/swelling (especially of the||
1546|105|S|face/tongue/throat), severe dizziness, trouble breathing.||
1546|106|S|   This is not a complete list of possible side effects. If you||
1546|107|S|notice other effects not listed above, contact your doctor or||
1546|108|S|pharmacist.||
1546|109|S|   In the US -||
1546|110|S|   Call your doctor for medical advice about side effects. You||
1546|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1546|112|S|www.fda.gov/medwatch.||
1546|113|S|   In Canada - Call your doctor for medical advice about side||
1546|114|S|effects. You may report side effects to Health Canada at||
1546|115|S|1-866-234-2345.||
1546|116|B|||
1546|117|P|PRECAUTIONS:  Before taking dabrafenib, tell your doctor or||
1546|118|P|pharmacist if you are allergic to it; or if you have any other||
1546|119|P|allergies. This product may contain inactive ingredients, which||
1546|120|P|can cause allergic reactions or other problems. Talk to your||
1546|121|P|pharmacist for more details.||
1546|122|P|   Before taking this medication, tell your doctor or pharmacist||
1546|123|P|your medical history, especially of: a certain enzyme deficiency||
1546|124|P|(G6PD deficiency), liver disease, diabetes.||
1546|125|P|   Before having surgery, tell your doctor or dentist about all||
1546|126|P|the products you use (including prescription drugs,||
1546|127|P|nonprescription drugs, and herbal products).||
1546|128|P|   Tell your doctor if you are pregnant or plan to become||
1546|129|P|pregnant. You should not become pregnant while using dabrafenib.||
1546|130|P|Dabrafenib may harm an unborn baby. Your doctor should order a||
1546|131|P|pregnancy test before you start this medication. Men and women||
1546|132|P|using this medication should ask about reliable forms of||
1546|133|P|non-hormonal birth control (such as condoms, diaphragm with||
1546|134|P|spermicide) during treatment and for 2 weeks after the last dose.||
1546|135|P|If you or your partner becomes pregnant, talk to your doctor||
1546|136|P|right away about the risks and benefits of this medication.||
1546|137|P|   Since this drug can be absorbed through the skin and lungs and||
1546|138|P|may harm an unborn baby, women who are pregnant or who may become||
1546|139|P|pregnant should not handle this medication or breathe the dust||
1546|140|P|from the capsules.||
1546|141|P|   It is unknown if this drug passes into breast milk. Because of||
1546|142|P|the possible risk to the infant, breastfeeding is not recommended||
1546|143|P|while using this drug and for 2 weeks after the last dose.||
1546|144|P|Consult your doctor before breastfeeding.||
1546|145|B|||
1546|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1546|147|I|medications work or increase your risk for serious side effects.||
1546|148|I|This document does not contain all possible drug interactions.||
1546|149|I|Keep a list of all the products you use (including||
1546|150|I|prescription/nonprescription drugs and herbal products) and share||
1546|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
1546|152|I|the dosage of any medicines without your doctor's approval.||
1546|153|I|   This medication may decrease the effectiveness of hormonal||
1546|154|I|birth control such as pills, patch, or ring. This could cause||
1546|155|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1546|156|I|use reliable backup birth control methods while using this||
1546|157|I|medication. Also tell your doctor if you have any new spotting or||
1546|158|I|breakthrough bleeding, because these may be signs that your birth||
1546|159|I|control is not working well.||
1546|160|I|   Other medications can affect the removal of dabrafenib from||
1546|161|I|your body, which may affect how dabrafenib works. Examples||
1546|162|I|include azole antifungals (such as itraconazole, ketoconazole),||
1546|163|I|gemfibrozil, macrolide antibiotics (such as clarithromycin,||
1546|164|I|erythromycin), nefazodone, St. John's wort, drugs used to treat||
1546|165|I|seizures (such as phenobarbital, phenytoin), among others.||
1546|166|I|   This medication can speed up the removal of other medications||
1546|167|I|from your body, which may affect how they work. Examples include||
1546|168|I|daridorexant, elacestrant, mavacamten, midazolam, quizartinib,||
1546|169|I|revumenib, warfarin, among others.||
1546|170|B|||
1546|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1546|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1546|173|O|poison control center right away. US residents can call||
1546|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1546|175|B|||
1546|176|N|NOTES:  Do not share this medication with others.||
1546|177|N|   Lab and/or medical tests (such as weight monitoring in||
1546|178|N|children) should be done before you start taking this medication||
1546|179|N|and while you are taking it. Keep all medical and lab||
1546|180|N|appointments. It is important to have regular skin exams while||
1546|181|N|taking dabrafenib and for up to 6 months after the last dose.||
1546|182|B|||
1546|183|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1546|184|D|remember. If it is within 6 hours of the next dose, skip the||
1546|185|D|missed dose. Take your next dose at the regular time. Do not||
1546|186|D|double the dose to catch up.||
1546|187|B|||
1546|188|R|STORAGE:  Store in the original container at room temperature||
1546|189|R|away from light and moisture. Do not store in the bathroom. Keep||
1546|190|R|the drying agent (desiccant) in the bottle. Tightly close the||
1546|191|R|bottle when not in use. Keep all medications away from children||
1546|192|R|and pets.||
1546|193|R|   Do not flush medications down the toilet or pour them into a||
1546|194|R|drain unless instructed to do so. Properly discard this product||
1546|195|R|when it is expired or no longer needed. Consult your pharmacist||
1546|196|R|or local waste disposal company.||
1546|197|B|||
1546|198|A|Information last revised December 2024.||
1546|199|A|Copyright(c) 2025 First Databank, Inc.||
1546|200|B|||
1547|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1547|002|Z|does NOT have all possible information about this product. This||
1547|003|Z|information does not assure that this product is safe, effective,||
1547|004|Z|or appropriate for you. This information is not individual||
1547|005|Z|medical advice and does not substitute for the advice of your||
1547|006|Z|health care professional. Always ask your health care||
1547|007|Z|professional for complete information about this product and your||
1547|008|Z|specific health needs.||
1547|009|B|||
1547|010|T|TRAMETINIB - ORAL||
1547|011|F|(tra-ME-ti-nib)||
1547|012|B|||
1547|013|C|COMMON BRAND NAME(S): Mekinist||
1547|014|B|||
1547|015|U|USES:  Trametinib is used to treat various cancers (such as skin,||
1547|016|U|thyroid, lung, solid tumors, brain). It belongs to a class of||
1547|017|U|drugs known as kinase inhibitors. Trametinib works by slowing or||
1547|018|U|stopping the growth of cancer cells.||
1547|019|B|||
1547|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1547|021|H|from your pharmacist before you start taking trametinib and each||
1547|022|H|time you get a refill. If you have any questions, ask your doctor||
1547|023|H|or pharmacist.||
1547|024|H|   Take this medication by mouth as directed by your doctor,||
1547|025|H|usually once daily. Take this medication on an empty stomach, at||
1547|026|H|least 1 hour before or 2 hours after a meal. Swallow the tablets||
1547|027|H|whole. Do not crush or break the tablets. The dosage is based on||
1547|028|H|your medical condition and response to treatment. Children's||
1547|029|H|dosage is also based on weight.||
1547|030|H|    If you vomit, do not take another dose to catch up. Take your||
1547|031|H|next dose at the regular time.||
1547|032|H|   Take this medication regularly to get the most benefit from||
1547|033|H|it. To help you remember, take it at the same time each day.||
1547|034|H|   Do not increase your dose or use this drug more often or for||
1547|035|H|longer than prescribed. Your condition will not improve any||
1547|036|H|faster, and your risk of side effects will increase.||
1547|037|H|   Since this drug can be absorbed through the skin and lungs and||
1547|038|H|may harm an unborn baby, women who are pregnant or who may become||
1547|039|H|pregnant should not handle this medication or breathe the dust||
1547|040|H|from the tablets.||
1547|041|B|||
1547|042|S|SIDE EFFECTS:  Dizziness, diarrhea, nausea/vomiting, stomach||
1547|043|S|pain, dry/itchy skin, acne, or dry mouth may occur. Weight gain||
1547|044|S|may also occur in children. If any of these effects last or get||
1547|045|S|worse, tell your doctor or pharmacist promptly. To relieve dry||
1547|046|S|mouth, suck (sugarless) hard candy or ice chips, chew (sugarless)||
1547|047|S|gum, drink water, or use a saliva substitute.||
1547|048|S|   Pain or sores in the mouth and throat may occur. Brush your||
1547|049|S|teeth carefully/gently, avoid using mouthwash that contains||
1547|050|S|alcohol, and rinse your mouth often with cool water mixed with||
1547|051|S|baking soda or salt. It may also be best to eat soft, moist||
1547|052|S|foods.||
1547|053|S|   People using this medication may have serious side effects.||
1547|054|S|However, you have been prescribed this drug because your doctor||
1547|055|S|has judged that the benefit to you is greater than the risk of||
1547|056|S|side effects. Careful monitoring by your doctor may decrease your||
1547|057|S|risk.||
1547|058|S|   This medication may raise your blood pressure. Check your||
1547|059|S|blood pressure regularly and tell your doctor if the results are||
1547|060|S|high.||
1547|061|S|   Tell your doctor right away if you have any serious side||
1547|062|S|effects, including: signs of heart failure (such as shortness of||
1547|063|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
1547|064|S|weight gain), signs of lung disease (such as cough, shortness of||
1547|065|S|breath, rapid breathing), signs of skin infection (such as||
1547|066|S|red/peeling/warm skin), signs of muscle damage (such as muscle||
1547|067|S|pain/tenderness/weakness, unusual tiredness), signs of kidney||
1547|068|S|problems (such as change in the amount of urine), easy||
1547|069|S|bleeding/bruising.||
1547|070|S|   Get medical help right away if you have any very serious side||
1547|071|S|effects, including: eye pain/swelling/redness, vision changes||
1547|072|S|(such as blurred vision, loss of vision, blind spots/shadows in||
1547|073|S|the center of your vision, sensitivity to light), signs of||
1547|074|S|bleeding in the brain (such as severe headache, weakness on one||
1547|075|S|side of the body, vision problems, trouble speaking, seizures, or||
1547|076|S|confusion), signs of serious stomach/intestinal problems (such as||
1547|077|S|severe stomach/abdominal pain, black/bloody stools, vomit that||
1547|078|S|contains blood or looks like coffee grounds, diarrhea with||
1547|079|S|blood/mucus), sudden pain/swelling/redness (usually in the leg),||
1547|080|S|chest pain, fast/irregular heartbeat, trouble breathing.||
1547|081|S|   Trametinib may make your blood sugar rise, which can cause or||
1547|082|S|worsen diabetes. Tell your doctor right away if you have symptoms||
1547|083|S|of high blood sugar such as increased thirst/urination. If you||
1547|084|S|already have diabetes, check your blood sugar regularly as||
1547|085|S|directed and share the results with your doctor. Your doctor may||
1547|086|S|need to adjust your diabetes medication, exercise program, or||
1547|087|S|diet.||
1547|088|S|   Although this medication is used to treat certain skin||
1547|089|S|cancers, it may rarely cause new skin cancer or other cancers.||
1547|090|S|Tell your doctor right away if you notice unusual skin changes||
1547|091|S|(such as skin sores/lumps, warts, change in the size/color of a||
1547|092|S|mole, skin bump that bleeds or does not heal). Your doctor should||
1547|093|S|check your skin before starting treatment, every 2 months during||
1547|094|S|treatment, and for up to 6 months after stopping this medication.||
1547|095|S|   Trametinib can commonly cause a rash that is usually not||
1547|096|S|serious. However, you may not be able to tell it apart from a||
1547|097|S|rare rash that could be a sign of a severe reaction. Get medical||
1547|098|S|help right away if you develop any rash.||
1547|099|S|   A very serious allergic reaction to this drug is rare.||
1547|100|S|However, get medical help right away if you notice any symptoms||
1547|101|S|of a serious allergic reaction, including: fever, swollen lymph||
1547|102|S|nodes, rash, itching/swelling (especially of the||
1547|103|S|face/tongue/throat), severe dizziness, trouble breathing.||
1547|104|S|   This is not a complete list of possible side effects. If you||
1547|105|S|notice other effects not listed above, contact your doctor or||
1547|106|S|pharmacist.||
1547|107|S|   In the US -||
1547|108|S|   Call your doctor for medical advice about side effects. You||
1547|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1547|110|S|www.fda.gov/medwatch.||
1547|111|S|   In Canada - Call your doctor for medical advice about side||
1547|112|S|effects. You may report side effects to Health Canada at||
1547|113|S|1-866-234-2345.||
1547|114|B|||
1547|115|P|PRECAUTIONS:  Before taking trametinib, tell your doctor or||
1547|116|P|pharmacist if you are allergic to it; or if you have any other||
1547|117|P|allergies. This product may contain inactive ingredients, which||
1547|118|P|can cause allergic reactions or other problems. Talk to your||
1547|119|P|pharmacist for more details.||
1547|120|P|   Before using this medication, tell your doctor or pharmacist||
1547|121|P|your medical history, especially of: high blood pressure, heart||
1547|122|P|disease (heart failure), lung problems, bleeding/blood problems,||
1547|123|P|diabetes, eye problems, stomach/intestinal problems (such as||
1547|124|P|diverticulitis).||
1547|125|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
1547|126|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
1547|127|P|use machinery, or do anything that needs alertness or clear||
1547|128|P|vision until you can do it safely. Limit alcoholic beverages.||
1547|129|P|Talk to your doctor if you are using marijuana (cannabis).||
1547|130|P|   Before having surgery, tell your doctor or dentist about all||
1547|131|P|the products you use (including prescription drugs,||
1547|132|P|nonprescription drugs, and herbal products).||
1547|133|P|   Older adults may be more sensitive to the side effects of this||
1547|134|P|drug, especially swelling of the arms/legs and loss of appetite.||
1547|135|P|   Since this drug can be absorbed through the skin and lungs and||
1547|136|P|may harm an unborn baby, women who are pregnant or who may become||
1547|137|P|pregnant should not handle this medication or breathe the dust||
1547|138|P|from the tablets.||
1547|139|P|   Tell your doctor if you are pregnant or plan to become||
1547|140|P|pregnant. You should not become pregnant while using trametinib.||
1547|141|P|Trametinib may harm an unborn baby. Your doctor should order a||
1547|142|P|pregnancy test before you start this medication. Women using this||
1547|143|P|medication should ask about reliable forms of birth control||
1547|144|P|during treatment and for 4 months after the last dose. Men||
1547|145|P|(including those who have had a vasectomy) using this medication||
1547|146|P|should ask about reliable forms of birth control during treatment||
1547|147|P|and for 4 months after the last dose. If you or your partner||
1547|148|P|becomes pregnant, talk to your doctor right away about the risks||
1547|149|P|and benefits of this medication.||
1547|150|P|   It is unknown if this drug passes into breast milk. Because of||
1547|151|P|the possible risk to the infant, breastfeeding is not recommended||
1547|152|P|while using this drug and for 4 months after the last dose.||
1547|153|P|Consult your doctor before breastfeeding.||
1547|154|B|||
1547|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1547|156|I|medications work or increase your risk for serious side effects.||
1547|157|I|This document does not contain all possible drug interactions.||
1547|158|I|Keep a list of all the products you use (including||
1547|159|I|prescription/nonprescription drugs and herbal products) and share||
1547|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
1547|161|I|the dosage of any medicines without your doctor's approval.||
1547|162|B|||
1547|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1547|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1547|165|O|poison control center right away. US residents can call||
1547|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1547|167|B|||
1547|168|N|NOTES:  Do not share this medication with others.||
1547|169|N|   Lab and/or medical tests (such as heart imaging, blood||
1547|170|N|pressure, blood sugar, skin checks, weight monitoring in||
1547|171|N|children) should be done before you start taking this medication||
1547|172|N|and while you are taking it. Keep all medical and lab||
1547|173|N|appointments.||
1547|174|B|||
1547|175|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1547|176|D|remember. If it is within 12 hours of the next dose, skip the||
1547|177|D|missed dose. Take your next dose at the regular time. Do not||
1547|178|D|double the dose to catch up.||
1547|179|B|||
1547|180|R|STORAGE:  Different brands of this medication have different||
1547|181|R|storage needs. Check the product package for instructions on how||
1547|182|R|to store your brand, or ask your pharmacist. Keep all medications||
1547|183|R|away from children and pets.||
1547|184|R|   Do not flush medications down the toilet or pour them into a||
1547|185|R|drain unless instructed to do so. Properly discard this product||
1547|186|R|when it is expired or no longer needed. Consult your pharmacist||
1547|187|R|or local waste disposal company.||
1547|188|B|||
1547|189|A|Information last revised March 2025.||
1547|190|A|Copyright(c) 2025 First Databank, Inc.||
1547|191|B|||
1548|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1548|002|Z|does NOT have all possible information about this product. This||
1548|003|Z|information does not assure that this product is safe, effective,||
1548|004|Z|or appropriate for you. This information is not individual||
1548|005|Z|medical advice and does not substitute for the advice of your||
1548|006|Z|health care professional. Always ask your health care||
1548|007|Z|professional for complete information about this product and your||
1548|008|Z|specific health needs.||
1548|009|B|||
1548|010|T|ESCITALOPRAM DISINTEGRATING TABLET - ORAL||
1548|011|F|(ES-sye-TAL-oh-pram)||
1548|012|B|||
1548|013|W|WARNING:  Antidepressant medications are used to treat a variety||
1548|014|W|of conditions, including depression and other mental/mood||
1548|015|W|disorders. These medications can help prevent suicidal||
1548|016|W|thoughts/attempts and provide other important benefits. However,||
1548|017|W|studies have shown that a small number of people (especially||
1548|018|W|people younger than 25) who take antidepressants for any||
1548|019|W|condition may experience worsening depression, other mental/mood||
1548|020|W|symptoms, or suicidal thoughts/attempts. It is very important to||
1548|021|W|talk with the doctor about the risks and benefits of||
1548|022|W|antidepressant medication (especially for people younger than||
1548|023|W|25), even if treatment is not for a mental/mood condition.||
1548|024|W|   Tell the doctor right away if you notice worsening||
1548|025|W|depression/other psychiatric conditions, unusual behavior changes||
1548|026|W|(including possible suicidal thoughts/attempts), or other||
1548|027|W|mental/mood changes (including new/worsening anxiety, panic||
1548|028|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1548|029|W|impulsive actions, severe restlessness, very rapid speech). Be||
1548|030|W|especially watchful for these symptoms when a new antidepressant||
1548|031|W|is started or when the dose is changed.||
1548|032|B|||
1548|033|U|USES:  This medication is used to treat certain mental/mood||
1548|034|U|disorders (such as depression, anxiety). Escitalopram belongs to||
1548|035|U|a class of drugs known as selective serotonin reuptake inhibitors||
1548|036|U|(SSRIs). It works by helping to restore the balance of a certain||
1548|037|U|natural substance (serotonin) in the brain.||
1548|038|B|||
1548|039|V|OTHER USES:  This section contains uses of this drug that are not||
1548|040|V|listed in the approved US professional labeling for the drug but||
1548|041|V|that may be prescribed by your health care professional. Use this||
1548|042|V|drug for a condition that is listed in this section only if it||
1548|043|V|has been so prescribed by your health care professional.||
1548|044|V|   This drug may also be used for other mental conditions (such||
1548|045|V|as obsessive-compulsive disorder, panic disorder) or binge eating||
1548|046|V|disorder (BED). It may also be used for hot flashes that occur||
1548|047|V|with menopause.||
1548|048|B|||
1548|049|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1548|050|H|from your pharmacist before you start taking escitalopram and||
1548|051|H|each time you get a refill. If you have any questions, ask your||
1548|052|H|doctor or pharmacist.||
1548|053|H|   Take this medication by mouth with or without food as directed||
1548|054|H|by your doctor, usually once daily in the morning or evening. The||
1548|055|H|dosage is based on your medical condition, response to treatment,||
1548|056|H|age, and other medications you may be taking. Be sure to tell||
1548|057|H|your doctor and pharmacist about all the products you use||
1548|058|H|(including prescription drugs, nonprescription drugs, and herbal||
1548|059|H|products).||
1548|060|H|   Dry your hands before peeling back the foil on the blister||
1548|061|H|pack to carefully remove a tablet. Do not push the tablet through||
1548|062|H|the foil. The tablet is fragile and is not intended to be cut,||
1548|063|H|split, or broken. Place each dose on the tongue, allow it to||
1548|064|H|dissolve completely, then swallow it with saliva. Do not remove||
1548|065|H|the tablet from the blister pack until just before taking. You do||
1548|066|H|not need to take this medication with water.||
1548|067|H|   To reduce your risk of side effects, your doctor may direct||
1548|068|H|you to start taking this drug at a low dose and gradually||
1548|069|H|increase your dose. Follow your doctor's instructions carefully.||
1548|070|H|Do not increase your dose or use this drug more often or for||
1548|071|H|longer than prescribed. Your condition will not improve any||
1548|072|H|faster, and your risk of side effects will increase. Take this||
1548|073|H|medication regularly to get the most benefit from it. To help you||
1548|074|H|remember, take it at the same time each day.||
1548|075|H|   Keep taking this medication even if you feel well. Do not stop||
1548|076|H|taking this medication without consulting your doctor. Some||
1548|077|H|conditions may become worse when this drug is suddenly stopped.||
1548|078|H|Also, you may experience symptoms such as mood swings, headache,||
1548|079|H|tiredness, sleep changes, and brief feelings similar to electric||
1548|080|H|shock. To prevent these symptoms while you are stopping treatment||
1548|081|H|with this drug, your doctor may reduce your dose gradually.||
1548|082|H|Consult your doctor or pharmacist for more details. Report any||
1548|083|H|new or worsening symptoms right away.||
1548|084|H|   It may take 1 to 2 weeks to feel a benefit from this drug and||
1548|085|H|4 weeks to feel the full benefit of this medication. Tell your||
1548|086|H|doctor if your condition does not get better or if it gets worse.||
1548|087|B|||
1548|088|S|SIDE EFFECTS:  See also Warning section.||
1548|089|S|   Nausea, dry mouth, trouble sleeping, constipation, tiredness,||
1548|090|S|drowsiness, dizziness, and increased sweating may occur. If any||
1548|091|S|of these effects last or get worse, tell your doctor promptly.||
1548|092|S|   Remember that this medication has been prescribed because your||
1548|093|S|doctor has judged that the benefit to you is greater than the||
1548|094|S|risk of side effects. Many people using this medication do not||
1548|095|S|have serious side effects.||
1548|096|S|   Tell your doctor right away if you have any serious side||
1548|097|S|effects, including: decreased interest in sex, changes in sexual||
1548|098|S|ability, easy bleeding/bruising.||
1548|099|S|   Get medical help right away if you have any very serious side||
1548|100|S|effects, including: black stools, fainting, fast/irregular||
1548|101|S|heartbeat, vomit that looks like coffee grounds, seizures, eye||
1548|102|S|pain/swelling/redness, widened pupils, vision changes (such as||
1548|103|S|seeing rainbows around lights at night, blurred vision).||
1548|104|S|   This medication may increase serotonin and rarely cause a very||
1548|105|S|serious condition called serotonin syndrome/toxicity. The risk||
1548|106|S|increases if you are also taking other drugs that increase||
1548|107|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1548|108|S|take (see Drug Interactions section). Get medical help right away||
1548|109|S|if you develop some of the following symptoms: fast heartbeat,||
1548|110|S|hallucinations, loss of coordination, severe dizziness, severe||
1548|111|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1548|112|S|unusual agitation/restlessness.||
1548|113|S|   Rarely, males may have a painful or prolonged erection lasting||
1548|114|S|4 or more hours. If this occurs, stop using this drug and get||
1548|115|S|medical help right away, or permanent problems could occur.||
1548|116|S|   A very serious allergic reaction to this drug is rare.||
1548|117|S|However, get medical help right away if you notice any symptoms||
1548|118|S|of a serious allergic reaction, including: rash, itching/swelling||
1548|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1548|120|S|breathing.||
1548|121|S|   This is not a complete list of possible side effects. If you||
1548|122|S|notice other effects not listed above, contact your doctor or||
1548|123|S|pharmacist.||
1548|124|S|   In the US -||
1548|125|S|   Call your doctor for medical advice about side effects. You||
1548|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1548|127|S|www.fda.gov/medwatch.||
1548|128|S|   In Canada - Call your doctor for medical advice about side||
1548|129|S|effects. You may report side effects to Health Canada at||
1548|130|S|1-866-234-2345.||
1548|131|B|||
1548|132|P|PRECAUTIONS:  Before taking escitalopram, tell your doctor or||
1548|133|P|pharmacist if you are allergic to it; or to citalopram; or if you||
1548|134|P|have any other allergies. This product may contain inactive||
1548|135|P|ingredients, which can cause allergic reactions or other||
1548|136|P|problems. Talk to your pharmacist for more details.||
1548|137|P|   Before using this medication, tell your doctor or pharmacist||
1548|138|P|your medical history, especially of: personal or family history||
1548|139|P|of bipolar/manic-depressive disorder, personal or family history||
1548|140|P|of suicide attempts, liver disease, seizures, bleeding problems,||
1548|141|P|low sodium in the blood (hyponatremia), personal or family||
1548|142|P|history of glaucoma (angle-closure type).||
1548|143|P|   Escitalopram may cause a condition that affects the heart||
1548|144|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1548|145|P|serious (rarely fatal) fast/irregular heartbeat and other||
1548|146|P|symptoms (such as severe dizziness, fainting) that need medical||
1548|147|P|attention right away.||
1548|148|P|   The risk of QT prolongation may be increased if you have||
1548|149|P|certain medical conditions or are taking other drugs that may||
1548|150|P|cause QT prolongation. Before using escitalopram, tell your||
1548|151|P|doctor or pharmacist of all the drugs you take and if you have||
1548|152|P|any of the following conditions: certain heart problems (heart||
1548|153|P|failure, slow heartbeat, recent heart attack, QT prolongation in||
1548|154|P|the EKG), family history of certain heart problems (QT||
1548|155|P|prolongation in the EKG, sudden cardiac death).||
1548|156|P|   Low levels of potassium or magnesium in the blood may also||
1548|157|P|increase your risk of QT prolongation. This risk may increase if||
1548|158|P|you use certain drugs (such as diuretics/"water pills") or if you||
1548|159|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1548|160|P|Talk to your doctor about using escitalopram safely.||
1548|161|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1548|162|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1548|163|P|machinery, or do anything that needs alertness until you can do||
1548|164|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1548|165|P|are using marijuana (cannabis).||
1548|166|P|   This medication may contain aspartame. If you have||
1548|167|P|phenylketonuria (PKU) or any other condition that requires you to||
1548|168|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
1548|169|P|doctor or pharmacist about using this medication safely.||
1548|170|P|   Before having surgery, tell your doctor or dentist about all||
1548|171|P|the products you use (including prescription drugs,||
1548|172|P|nonprescription drugs, and herbal products).||
1548|173|P|   Older adults may be more sensitive to the side effects of this||
1548|174|P|drug, especially QT prolongation (see above), loss of||
1548|175|P|coordination, or bleeding. They may also be more likely to lose||
1548|176|P|too much salt (hyponatremia), especially if they are also taking||
1548|177|P|"water pills" (diuretics) with this medication. Loss of||
1548|178|P|coordination can increase the risk of falling.||
1548|179|P|   Children may be more sensitive to the side effects of this||
1548|180|P|drug, especially loss of appetite and weight loss. Monitor weight||
1548|181|P|and height in children who are taking this drug.||
1548|182|P|   During pregnancy, this medication should be used only when||
1548|183|P|clearly needed. It may harm an unborn baby. Also, babies born to||
1548|184|P|mothers who have used this drug during the last 3 months of||
1548|185|P|pregnancy may rarely develop withdrawal symptoms such as||
1548|186|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
1548|187|P|constant crying. If you notice any of these symptoms in your||
1548|188|P|newborn, tell the doctor promptly.||
1548|189|P|   Since untreated mental/mood problems (such as depression,||
1548|190|P|anxiety, obsessive-compulsive disorder, panic disorder) can be a||
1548|191|P|serious condition, do not stop using this medication unless||
1548|192|P|directed by your doctor. If you are planning pregnancy, become||
1548|193|P|pregnant, or think you may be pregnant, immediately discuss with||
1548|194|P|your doctor the benefits and risks of using this medication||
1548|195|P|during pregnancy.||
1548|196|P|   This medication passes into breast milk and may have||
1548|197|P|undesirable effects on a nursing infant. Consult your doctor||
1548|198|P|before breastfeeding.||
1548|199|B|||
1548|200|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1548|201|I|medications work or increase your risk for serious side effects.||
1548|202|I|This document does not contain all possible drug interactions.||
1548|203|I|Keep a list of all the products you use (including||
1548|204|I|prescription/nonprescription drugs and herbal products) and share||
1548|205|I|it with your doctor and pharmacist. Do not start, stop, or change||
1548|206|I|the dosage of any medicines without your doctor's approval.||
1548|207|I|   Some products that may interact with this drug are: other||
1548|208|I|drugs that can cause bleeding/bruising (including antiplatelet||
1548|209|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
1548|210|I|"blood thinners" such as dabigatran/warfarin).||
1548|211|I|   Aspirin can increase the risk of bleeding when used with this||
1548|212|I|medication. However, if your doctor has told you to take low-dose||
1548|213|I|aspirin to prevent heart attack or stroke (usually 81-162||
1548|214|I|milligrams a day), you should keep taking the aspirin unless your||
1548|215|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1548|216|I|details.||
1548|217|I|   Taking MAO inhibitors with this medication may cause a serious||
1548|218|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1548|219|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1548|220|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1548|221|I|selegiline, tranylcypromine) during treatment with this||
1548|222|I|medication. Most MAO inhibitors should also not be taken for two||
1548|223|I|weeks before and after treatment with this medication. Ask your||
1548|224|I|doctor when to start or stop taking this medication.||
1548|225|I|   The risk of serotonin syndrome/toxicity increases if you are||
1548|226|I|also taking other drugs that increase serotonin. Examples include||
1548|227|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1548|228|I|antidepressants (including other SSRIs such as||
1548|229|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
1548|230|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
1548|231|I|may be more likely when you start or increase the dose of these||
1548|232|I|drugs.||
1548|233|I|   Tell your doctor or pharmacist if you are taking other||
1548|234|I|products that cause drowsiness including alcohol, marijuana||
1548|235|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1548|236|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1548|237|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1548|238|I|codeine).||
1548|239|I|   Check the labels on all your medicines (such as allergy,||
1548|240|I|pain/fever reducers, or cough-and-cold products) because they may||
1548|241|I|contain ingredients that cause drowsiness or increase the risk of||
1548|242|I|bleeding. Ask your pharmacist about using those products safely.||
1548|243|I|   Many drugs besides escitalopram may affect the heart rhythm||
1548|244|I|(QT prolongation), including amiodarone, pimozide, procainamide,||
1548|245|I|quinidine, sotalol, among others.||
1548|246|I|   Escitalopram is very similar to citalopram. Do not use||
1548|247|I|medications containing citalopram while using escitalopram.||
1548|248|I|   This medication may interfere with certain medical/lab tests||
1548|249|I|(such as brain scan for Parkinson's disease), possibly causing||
1548|250|I|false test results. Make sure lab personnel and all your doctors||
1548|251|I|know you use this drug.||
1548|252|B|||
1548|253|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1548|254|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1548|255|O|poison control center right away. US residents can call||
1548|256|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1548|257|B|||
1548|258|N|NOTES:  Do not share this medication with others.||
1548|259|N|   Keep all medical and lab appointments.||
1548|260|B|||
1548|261|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1548|262|D|remember. If it is near the time of the next dose, skip the||
1548|263|D|missed dose. Take your next dose at the regular time. Do not||
1548|264|D|double the dose to catch up.||
1548|265|B|||
1548|266|R|STORAGE:  Store at room temperature away from light and moisture.||
1548|267|R|Do not store in the bathroom. Keep all medications away from||
1548|268|R|children and pets.||
1548|269|R|   Do not flush medications down the toilet or pour them into a||
1548|270|R|drain unless instructed to do so. Properly discard this product||
1548|271|R|when it is expired or no longer needed. Consult your pharmacist||
1548|272|R|or local waste disposal company.||
1548|273|B|||
1548|274|A|Information last revised February 2025.||
1548|275|A|Copyright(c) 2025 First Databank, Inc.||
1548|276|B|||
1549|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1549|002|Z|does NOT have all possible information about this product. This||
1549|003|Z|information does not assure that this product is safe, effective,||
1549|004|Z|or appropriate for you. This information is not individual||
1549|005|Z|medical advice and does not substitute for the advice of your||
1549|006|Z|health care professional. Always ask your health care||
1549|007|Z|professional for complete information about this product and your||
1549|008|Z|specific health needs.||
1549|009|B|||
1549|010|T|SODIUM POLYSTYRENE SULFONATE ENEMA - RECTAL||
1549|011|F|(SOE-dee-um POL-ee-STYE-reen SUL-foe-nate)||
1549|012|B|||
1549|013|C|COMMON BRAND NAME(S): SPS||
1549|014|B|||
1549|015|U|USES:  This medication is used to treat a high level of potassium||
1549|016|U|in your blood. Too much potassium in your blood can sometimes||
1549|017|U|cause heart rhythm problems. Sodium polystyrene sulfonate works||
1549|018|U|by helping your body get rid of extra potassium.||
1549|019|B|||
1549|020|H|HOW TO USE:  Read the product instructions and directions from||
1549|021|H|your doctor or pharmacist before you start using this medication||
1549|022|H|and each time you get a refill. If you have any questions, ask||
1549|023|H|your doctor or pharmacist.||
1549|024|H|   Shake the bottle well before using.||
1549|025|H|   You may warm the suspension container to body temperature;||
1549|026|H|however, do not heat this medication because doing so may change||
1549|027|H|how well it works.||
1549|028|H|   Follow instructions for the use of a cleansing enema before||
1549|029|H|using this medication.||
1549|030|H|   Use sodium polystyrene sulfonate rectally as an enema as||
1549|031|H|directed by your doctor, usually every 6 hours as needed. Keep||
1549|032|H|the enema in the rectum for several hours, if possible.||
1549|033|H|   Use a non-sodium-containing cleansing enema after each dose as||
1549|034|H|directed.||
1549|035|H|   The dosage and length of treatment are based on your medical||
1549|036|H|condition and response to treatment. Follow your doctor's||
1549|037|H|instructions carefully. Do not use more of this medication or use||
1549|038|H|it for longer than directed because your potassium blood level||
1549|039|H|may drop too low.||
1549|040|H|   Keep all lab and medical appointments so your doctor can check||
1549|041|H|your potassium blood level.||
1549|042|B|||
1549|043|S|SIDE EFFECTS:  Loss of appetite, nausea, vomiting, or||
1549|044|S|constipation may occur. Less often, diarrhea may occur. If any of||
1549|045|S|these effects last or get worse, tell your doctor or pharmacist||
1549|046|S|promptly.||
1549|047|S|   To prevent constipation, eat dietary fiber, drink enough||
1549|048|S|water, and exercise. You may also need to take a laxative. Ask||
1549|049|S|your pharmacist which type of laxative is right for you.||
1549|050|S|   Remember that this medication has been prescribed because your||
1549|051|S|doctor has judged that the benefit to you is greater than the||
1549|052|S|risk of side effects. Many people using this medication do not||
1549|053|S|have serious side effects.||
1549|054|S|   Tell your doctor right away if you have any serious side||
1549|055|S|effects, including: muscle weakness/spasms, fast/irregular||
1549|056|S|heartbeat, mental/mood changes (such as irritability, confusion,||
1549|057|S|slowed thinking), swelling hands/ankles/feet.||
1549|058|S|   This medication may cause serious (rarely fatal) intestinal||
1549|059|S|problems (such as bleeding, blockage). Get medical help right||
1549|060|S|away if any of these very serious side effects occur: severe||
1549|061|S|constipation, bloating/swelling/pain in the stomach/abdomen,||
1549|062|S|black/bloody stools, vomit that looks like coffee grounds.||
1549|063|S|   Get medical help right away if you have any very serious side||
1549|064|S|effects, including: inability to move your muscles (paralysis),||
1549|065|S|seizures.||
1549|066|S|   A very serious allergic reaction to this drug is rare.||
1549|067|S|However, get medical help right away if you notice any symptoms||
1549|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1549|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1549|070|S|breathing.||
1549|071|S|   This is not a complete list of possible side effects. If you||
1549|072|S|notice other effects not listed above, contact your doctor or||
1549|073|S|pharmacist.||
1549|074|S|   In the US -||
1549|075|S|   Call your doctor for medical advice about side effects. You||
1549|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1549|077|S|www.fda.gov/medwatch.||
1549|078|S|   In Canada - Call your doctor for medical advice about side||
1549|079|S|effects. You may report side effects to Health Canada at||
1549|080|S|1-866-234-2345.||
1549|081|B|||
1549|082|P|PRECAUTIONS:  Before using sodium polystyrene sulfonate, tell||
1549|083|P|your doctor or pharmacist if you are allergic to it; or if you||
1549|084|P|have any other allergies. This product may contain inactive||
1549|085|P|ingredients, which can cause allergic reactions or other||
1549|086|P|problems. Talk to your pharmacist for more details.||
1549|087|P|   This medication contains a large amount of salt (sodium). Do||
1549|088|P|not use salt substitutes that contain potassium without asking||
1549|089|P|your doctor first. If you have any of these conditions, follow||
1549|090|P|your doctor's instructions for limiting the amount of sodium in||
1549|091|P|your diet: kidney problems, heart failure, high blood pressure,||
1549|092|P|swelling hands/ankles/feet.||
1549|093|P|   Before using this medication, tell your doctor or pharmacist||
1549|094|P|your medical history, especially of: stomach/intestine/bowel||
1549|095|P|problems (such as inflammatory bowel disease, bowel obstruction,||
1549|096|P|chronic constipation, fecal impaction), low level of potassium in||
1549|097|P|the blood.||
1549|098|P|   Before having surgery, tell your doctor or dentist about all||
1549|099|P|the products you use (including prescription drugs,||
1549|100|P|nonprescription drugs, and herbal products).||
1549|101|P|   Older adults may be at greater risk for severe constipation.||
1549|102|P|   This medication must not be given by mouth to newborns,||
1549|103|P|especially premature infants. Also, newborns with slow gut||
1549|104|P|function must not use this drug. Caution is advised when using||
1549|105|P|this medication rectally in newborns and children. They may be||
1549|106|P|more sensitive to the side effects of this drug, especially||
1549|107|P|severe constipation and intestinal problems.||
1549|108|P|   Tell your doctor if you are pregnant before using this||
1549|109|P|medication.||
1549|110|P|   This medication does not pass into breast milk and is unlikely||
1549|111|P|to harm a nursing infant. Consult your doctor before||
1549|112|P|breastfeeding.||
1549|113|B|||
1549|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1549|115|I|medications work or increase your risk for serious side effects.||
1549|116|I|This document does not contain all possible drug interactions.||
1549|117|I|Keep a list of all the products you use (including||
1549|118|I|prescription/nonprescription drugs and herbal products) and share||
1549|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
1549|120|I|the dosage of any medicines without your doctor's approval.||
1549|121|I|   Do not use any laxatives that contain sorbitol with this||
1549|122|I|medication. Doing so may increase your risk of intestinal||
1549|123|I|problems. See also Side Effects section.||
1549|124|B|||
1549|125|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1549|126|O|has overdosed and has serious symptoms such as passing out or||
1549|127|O|trouble breathing, call 911. Otherwise, call a poison control||
1549|128|O|center right away. US residents can call 1-800-222-1222. Canada||
1549|129|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1549|130|O|include: mental/mood changes, muscle weakness, fast/irregular||
1549|131|O|heartbeat, slowed breathing, paralysis.||
1549|132|B|||
1549|133|N|NOTES:  Do not share this medication with others.||
1549|134|N|   Lab and/or medical tests (such as blood levels of potassium||
1549|135|N|and other minerals, EKG) should be done while you are using this||
1549|136|N|medication. Keep all medical and lab appointments. Consult your||
1549|137|N|doctor for more details.||
1549|138|B|||
1549|139|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1549|140|D|If it is near the time of the next dose, skip the missed dose.||
1549|141|D|Use your next dose at the regular time. Do not double the dose to||
1549|142|D|catch up.||
1549|143|B|||
1549|144|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
1549|145|R|medications away from children and pets.||
1549|146|R|   Do not flush medications down the toilet or pour them into a||
1549|147|R|drain unless instructed to do so. Properly discard this product||
1549|148|R|when it is expired or no longer needed. Consult your pharmacist||
1549|149|R|or local waste disposal company.||
1549|150|B|||
1549|151|A|Information last revised September 2024.||
1549|152|A|Copyright(c) 2025 First Databank, Inc.||
1549|153|B|||
1550|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1550|002|Z|does NOT have all possible information about this product. This||
1550|003|Z|information does not assure that this product is safe, effective,||
1550|004|Z|or appropriate for you. This information is not individual||
1550|005|Z|medical advice and does not substitute for the advice of your||
1550|006|Z|health care professional. Always ask your health care||
1550|007|Z|professional for complete information about this product and your||
1550|008|Z|specific health needs.||
1550|009|B|||
1550|010|T|FLUTICASONE/VILANTEROL POWDER INHALER - ORAL INHALATION||
1550|011|F|(floo-TIK-a-sone/vye-LAN-ter-ol)||
1550|012|B|||
1550|013|C|COMMON BRAND NAME(S): Breo Ellipta||
1550|014|B|||
1550|015|U|USES:  This medication is used to prevent and decrease symptoms||
1550|016|U|(wheezing and trouble breathing) caused by asthma and ongoing||
1550|017|U|lung disease (chronic obstructive pulmonary disease-COPD,||
1550|018|U|including chronic bronchitis and emphysema). This inhaler||
1550|019|U|contains 2 medications: fluticasone and vilanterol. Fluticasone||
1550|020|U|belongs to a class of drugs known as corticosteroids. It works by||
1550|021|U|reducing the swelling of the airways in the lungs to make||
1550|022|U|breathing easier. Vilanterol belongs to a class of drugs known as||
1550|023|U|long-acting beta agonists. It works by relaxing the muscles||
1550|024|U|around the airways so that they open up and you can breathe more||
1550|025|U|easily.||
1550|026|U|   When used alone, long-acting beta agonists (like vilanterol)||
1550|027|U|may rarely increase the risk of serious (sometimes fatal)||
1550|028|U|asthma-related breathing problems. However, combination inhaled||
1550|029|U|corticosteroid and long-acting beta agonists, such as this||
1550|030|U|product, do not increase the risk of serious asthma-related||
1550|031|U|breathing problems. For asthma treatment, this product should be||
1550|032|U|used when breathing problems are not well controlled with one||
1550|033|U|asthma-control medication (such as inhaled corticosteroid) or if||
1550|034|U|your symptoms need combination treatment.||
1550|035|U|   Before using this medication, it is important to learn how to||
1550|036|U|use it properly. This medication must be used regularly to be||
1550|037|U|effective. It does not work right away and should not be used to||
1550|038|U|relieve sudden asthma attacks. If an asthma attack occurs, use||
1550|039|U|your quick-relief inhaler (such as albuterol, also called||
1550|040|U|salbutamol in some countries) as prescribed.||
1550|041|B|||
1550|042|H|HOW TO USE:  Read the Patient Information Leaflet and||
1550|043|H|Instructions for Use provided by your pharmacist before you start||
1550|044|H|using this medication and each time you get a refill. Follow the||
1550|045|H|illustrated directions for the proper use of this medication. If||
1550|046|H|you have any questions, ask your doctor or pharmacist.||
1550|047|H|   Inhale this medication by mouth as directed by your doctor,||
1550|048|H|usually once daily. Do not use more than 1 inhalation daily. If||
1550|049|H|you open and close the cover without inhaling this medication,||
1550|050|H|you will lose the dose. If this happens, you should load a new||
1550|051|H|dose and inhale it.||
1550|052|H|   If you have been using a quick-relief inhaler (such as||
1550|053|H|albuterol, also called salbutamol in some countries) on a regular||
1550|054|H|daily schedule (such as 4 times daily), you must stop this||
1550|055|H|schedule and only use it as needed for sudden shortness of||
1550|056|H|breath. Contact your doctor for details.||
1550|057|H|   If you are using other inhalers at the same time, wait at||
1550|058|H|least 1 minute between the use of each medication, and use this||
1550|059|H|drug last.||
1550|060|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
1550|061|H|from developing, gargle, rinse your mouth with water and spit out||
1550|062|H|after each use. Do not swallow the rinse water.||
1550|063|H|   Use this medication regularly to get the most benefit from it.||
1550|064|H|To help you remember, use it at the same time each day. Do not||
1550|065|H|increase your dose, use this medication more often, or stop using||
1550|066|H|it without talking to your doctor. Also, do not use other||
1550|067|H|long-acting beta agonists while using this medication.||
1550|068|H|   If this medication stops working well, or you need to use your||
1550|069|H|quick-relief inhaler more often than usual (4 or more puffs daily||
1550|070|H|or use of more than 1 inhaler every 8 weeks), get medical help||
1550|071|H|right away. It may be a sign of worsening asthma or COPD, which||
1550|072|H|is a serious condition.||
1550|073|H|   Learn which of your inhalers you should use every day and||
1550|074|H|which you should use if your breathing suddenly worsens||
1550|075|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1550|076|H|should do if you have new or worsening cough or shortness of||
1550|077|H|breath, wheezing, increased sputum, waking up at night with||
1550|078|H|trouble breathing, if you use your quick-relief inhaler more||
1550|079|H|often, or if your quick-relief inhaler does not seem to be||
1550|080|H|working well. Learn when you can treat sudden breathing problems||
1550|081|H|by yourself and when you must get medical help right away.||
1550|082|H|   If you are regularly taking corticosteroids by mouth (such as||
1550|083|H|prednisone), continue to follow your doctor's instructions on||
1550|084|H|taking them. Do not stop taking them. Your doctor may want you to||
1550|085|H|reduce your dose gradually.||
1550|086|H|   It may take several weeks or longer before you get the full||
1550|087|H|benefit of this drug. Tell your doctor if your condition does not||
1550|088|H|get better or if it gets worse.||
1550|089|B|||
1550|090|S|SIDE EFFECTS:  See also Precautions section.||
1550|091|S|   Headache, dry/irritated throat, hoarseness, runny nose, and||
1550|092|S|coughing may occur as your body adjusts to the medication. If any||
1550|093|S|of these effects last or get worse, tell your doctor or||
1550|094|S|pharmacist promptly.||
1550|095|S|   Remember that this medication has been prescribed because your||
1550|096|S|doctor has judged that the benefit to you is greater than the||
1550|097|S|risk of side effects. Many people using this medication do not||
1550|098|S|have serious side effects.||
1550|099|S|   This medication may raise your blood pressure. Check your||
1550|100|S|blood pressure regularly and tell your doctor if the results are||
1550|101|S|high.||
1550|102|S|   Tell your doctor right away if you have any serious side||
1550|103|S|effects, including: white patches in your mouth or on your||
1550|104|S|tongue, weakness, puffy face, unusual weight gain, slow wound||
1550|105|S|healing, thinning skin, bone pain, menstrual period changes,||
1550|106|S|mental/mood changes (such as depression, nervousness, mood||
1550|107|S|swings, agitation), easy bruising/bleeding, increased||
1550|108|S|thirst/urination, vision problems, muscle cramps, shaking||
1550|109|S|(tremor), signs of infection (such as sore throat that doesn't go||
1550|110|S|away, fever, chills).||
1550|111|S|   Get medical help right away if you have any very serious side||
1550|112|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1550|113|S|fainting, chest pain.||
1550|114|S|   Rarely, this medication has caused severe (rarely fatal),||
1550|115|S|sudden worsening of breathing problems (paradoxical||
1550|116|S|bronchospasm). If you have trouble breathing, use your||
1550|117|S|quick-relief inhaler and get medical help right away.||
1550|118|S|   A very serious allergic reaction to this drug is rare.||
1550|119|S|However, get medical help right away if you notice any symptoms||
1550|120|S|of a serious allergic reaction, including: rash, itching/swelling||
1550|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1550|122|S|breathing.||
1550|123|S|   This is not a complete list of possible side effects. If you||
1550|124|S|notice other effects not listed above, contact your doctor or||
1550|125|S|pharmacist.||
1550|126|S|   In the US -||
1550|127|S|   Call your doctor for medical advice about side effects. You||
1550|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1550|129|S|www.fda.gov/medwatch.||
1550|130|S|   In Canada - Call your doctor for medical advice about side||
1550|131|S|effects. You may report side effects to Health Canada at||
1550|132|S|1-866-234-2345.||
1550|133|B|||
1550|134|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1550|135|P|pharmacist if you are allergic to fluticasone or vilanterol; or||
1550|136|P|if you have any other allergies. This product may contain||
1550|137|P|inactive ingredients (such as milk proteins), which can cause||
1550|138|P|allergic reactions or other problems. Talk to your pharmacist for||
1550|139|P|more details.||
1550|140|P|   Before using this medication, tell your doctor or pharmacist||
1550|141|P|your medical history, especially of: high blood pressure, bone||
1550|142|P|loss (osteoporosis), depression, diabetes, eye problems (such as||
1550|143|P|cataracts, glaucoma), heart problems (such as angina, irregular||
1550|144|P|heartbeat), any recent infection, liver problems, overactive||
1550|145|P|thyroid (hyperthyroidism), seizures.||
1550|146|P|   Fluticasone/vilanterol may cause a condition that affects the||
1550|147|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
1550|148|P|serious (rarely fatal) fast/irregular heartbeat and other||
1550|149|P|symptoms (such as severe dizziness, fainting) that need medical||
1550|150|P|attention right away.||
1550|151|P|   The risk of QT prolongation may be increased if you have||
1550|152|P|certain medical conditions or are taking other drugs that may||
1550|153|P|cause QT prolongation. Before using fluticasone/vilanterol, tell||
1550|154|P|your doctor or pharmacist of all the drugs you take and if you||
1550|155|P|have any of the following conditions: certain heart problems||
1550|156|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
1550|157|P|family history of certain heart problems (QT prolongation in the||
1550|158|P|EKG, sudden cardiac death).||
1550|159|P|   Low levels of potassium or magnesium in the blood may also||
1550|160|P|increase your risk of QT prolongation. This risk may increase if||
1550|161|P|you use certain drugs (such as diuretics/"water pills") or if you||
1550|162|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1550|163|P|Talk to your doctor about using fluticasone/vilanterol safely.||
1550|164|P|   If you have switched from a corticosteroid taken by mouth||
1550|165|P|(such as prednisone tablets) to this inhaler within the past 12||
1550|166|P|months, or if you have been using this product in||
1550|167|P|higher-than-usual doses for a long time, it may be more difficult||
1550|168|P|for your body to respond to physical stress. Before having||
1550|169|P|surgery or emergency treatment, or if you get a serious||
1550|170|P|illness/injury, tell your doctor or dentist that you are using||
1550|171|P|this medication or have used a corticosteroid taken by mouth||
1550|172|P|within the past 12 months. Tell your doctor right away if you||
1550|173|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
1550|174|P|card or medical ID bracelet that says you use (or have used)||
1550|175|P|corticosteroid medications.||
1550|176|P|   Before having surgery, tell your doctor or dentist about all||
1550|177|P|the products you use (including prescription drugs,||
1550|178|P|nonprescription drugs, and herbal products).||
1550|179|P|   Fluticasone/vilanterol can make you more likely to get||
1550|180|P|infections or may make current infections worse. Stay away from||
1550|181|P|anyone who has an infection that may easily spread (such as||
1550|182|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
1550|183|P|have been exposed to an infection or for more details.||
1550|184|P|   This medication may temporarily slow down a child's growth if||
1550|185|P|used for a long time. However, poorly controlled asthma can also||
1550|186|P|slow down growth. See the doctor regularly so your child's height||
1550|187|P|can be checked.||
1550|188|P|   Older adults may be more sensitive to the side effects of this||
1550|189|P|drug, especially QT prolongation (see above).||
1550|190|P|   During pregnancy, this medication should be used only when||
1550|191|P|clearly needed. Discuss the risks and benefits with your doctor.||
1550|192|P|   It is unknown if this medication passes into breast milk.||
1550|193|P|However, similar drugs pass into breast milk. Consult your doctor||
1550|194|P|before breastfeeding.||
1550|195|B|||
1550|196|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1550|197|I|medications work or increase your risk for serious side effects.||
1550|198|I|This document does not contain all possible drug interactions.||
1550|199|I|Keep a list of all the products you use (including||
1550|200|I|prescription/nonprescription drugs and herbal products) and share||
1550|201|I|it with your doctor and pharmacist. Do not start, stop, or change||
1550|202|I|the dosage of any medicines without your doctor's approval.||
1550|203|I|   A product that may interact with this drug is: desmopressin.||
1550|204|I|   Other medications can affect the removal of fluticasone from||
1550|205|I|your body, which may affect how fluticasone works. Examples||
1550|206|I|include some azole antifungals (such as ketoconazole), HIV||
1550|207|I|protease inhibitors (such as lopinavir), ritonavir, among others.||
1550|208|B|||
1550|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1550|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1550|211|O|poison control center right away. US residents can call||
1550|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1550|213|O|Symptoms of overdose may include: chest pain, fast heartbeat,||
1550|214|O|shaking (tremor).||
1550|215|B|||
1550|216|N|NOTES:  Do not share this medication with others.||
1550|217|N|   Lab and/or medical tests (such as cortisol levels, lung||
1550|218|N|function, eye exam, bone density tests) should be done while you||
1550|219|N|are using this medication. Keep all medical and lab appointments.||
1550|220|N|Consult your doctor for more details.||
1550|221|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
1550|222|N|mold that can worsen breathing problems. Because the flu virus||
1550|223|N|can also worsen breathing problems, ask your doctor or pharmacist||
1550|224|N|if you should have a flu shot every year.||
1550|225|N|   This medication may cause bone loss (osteoporosis) in adults||
1550|226|N|when used for a long time. Lifestyle changes that may help reduce||
1550|227|N|the risk of bone problems include doing weight-bearing exercise,||
1550|228|N|stopping smoking, limiting alcohol, and getting enough calcium||
1550|229|N|and vitamin D. Talk to your doctor for more details.||
1550|230|B|||
1550|231|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1550|232|D|If it is near the time of the next dose, skip the missed dose.||
1550|233|D|Use your next dose at the regular time. Do not double the dose to||
1550|234|D|catch up.||
1550|235|B|||
1550|236|R|STORAGE:  Different brands of this medication have different||
1550|237|R|storage needs. Check the product package for instructions on how||
1550|238|R|to store your brand, or ask your pharmacist. Do not open the||
1550|239|R|original foil package until you are ready to use the medication.||
1550|240|R|Once the foil package is opened, this medication expires after 6||
1550|241|R|weeks. Keep all medications away from children and pets.||
1550|242|R|   Do not flush medications down the toilet or pour them into a||
1550|243|R|drain unless instructed to do so. Properly discard this product||
1550|244|R|when it is expired or no longer needed. Consult your pharmacist||
1550|245|R|or local waste disposal company.||
1550|246|B|||
1550|247|M|MEDICAL ALERT:  Your condition can cause complications in a||
1550|248|M|medical emergency. For information about enrolling in MedicAlert,||
1550|249|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1550|250|B|||
1550|251|A|Information last revised September 2025.||
1550|252|A|Copyright(c) 2025 First Databank, Inc.||
1550|253|B|||
1551|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1551|002|Z|does NOT have all possible information about this product. This||
1551|003|Z|information does not assure that this product is safe, effective,||
1551|004|Z|or appropriate for you. This information is not individual||
1551|005|Z|medical advice and does not substitute for the advice of your||
1551|006|Z|health care professional. Always ask your health care||
1551|007|Z|professional for complete information about this product and your||
1551|008|Z|specific health needs.||
1551|009|B|||
1551|010|T|NAFTIFINE 2% GEL - TOPICAL||
1551|011|F|(NAF-ti-feen)||
1551|012|B|||
1551|013|C|COMMON BRAND NAME(S): Naftin||
1551|014|B|||
1551|015|U|USES:  This medication is used to treat athlete's foot, a type of||
1551|016|U|fungal skin infection. It helps to get rid of the redness,||
1551|017|U|itching, and scaling. Naftifine is an antifungal that works by||
1551|018|U|preventing the growth of fungus.||
1551|019|B|||
1551|020|H|HOW TO USE:  Use this medication on the skin only. Clean and||
1551|021|H|thoroughly dry the area to be treated. Apply a thin layer of the||
1551|022|H|medication to and around the affected area and gently rub in.||
1551|023|H|Apply this medication as directed by your doctor, usually once||
1551|024|H|daily for 2 weeks. Wash your hands after use. Do not wrap, cover,||
1551|025|H|or bandage the area unless directed to do so by your doctor.||
1551|026|H|   Do not use the medication in the eyes, nose, mouth, or inside||
1551|027|H|the vagina. If you get the medication in any of these areas,||
1551|028|H|flush with plenty of water.||
1551|029|H|   Do not apply more often or use for longer than prescribed.||
1551|030|H|This may increase the risk of side effects.||
1551|031|H|   Use this medication regularly to get the most benefit from it.||
1551|032|H|To help you remember, use it at the same time each day.||
1551|033|H|   Continue to use this medication until the full prescribed||
1551|034|H|treatment period is finished, even if symptoms disappear after a||
1551|035|H|few days. Stopping the medication too early may result in a||
1551|036|H|return of the infection.||
1551|037|H|   Tell your doctor if your condition lasts or gets worse.||
1551|038|B|||
1551|039|S|SIDE EFFECTS:  Mild irritation at the application site may occur.||
1551|040|S|If this lasts or gets worse, tell your doctor or pharmacist||
1551|041|S|promptly.||
1551|042|S|   Remember that this medication has been prescribed because your||
1551|043|S|doctor has judged that the benefit to you is greater than the||
1551|044|S|risk of side effects. Many people using this medication do not||
1551|045|S|have serious side effects.||
1551|046|S|   A very serious allergic reaction to this drug is rare.||
1551|047|S|However, get medical help right away if you notice any symptoms||
1551|048|S|of a serious allergic reaction, including: rash, itching/swelling||
1551|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1551|050|S|breathing.||
1551|051|S|   This is not a complete list of possible side effects. If you||
1551|052|S|notice other effects not listed above, contact your doctor or||
1551|053|S|pharmacist.||
1551|054|S|   In the US -||
1551|055|S|   Call your doctor for medical advice about side effects. You||
1551|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1551|057|S|www.fda.gov/medwatch.||
1551|058|S|   In Canada - Call your doctor for medical advice about side||
1551|059|S|effects. You may report side effects to Health Canada at||
1551|060|S|1-866-234-2345.||
1551|061|B|||
1551|062|P|PRECAUTIONS:  Before using naftifine, tell your doctor or||
1551|063|P|pharmacist if you are allergic to it; or to other antifungals||
1551|064|P|(such as terbinafine); or if you have any other allergies. This||
1551|065|P|product may contain inactive ingredients, which can cause||
1551|066|P|allergic reactions or other problems. Talk to your pharmacist for||
1551|067|P|more details.||
1551|068|P|   Before using this medication, tell your doctor or pharmacist||
1551|069|P|your medical history.||
1551|070|P|   Before having surgery, tell your doctor or dentist about all||
1551|071|P|the products you use (including prescription drugs,||
1551|072|P|nonprescription drugs, and herbal products).||
1551|073|P|   During pregnancy, this medication should be used only when||
1551|074|P|clearly needed. Discuss the risks and benefits with your doctor.||
1551|075|P|   It is unknown if this drug passes into breast milk. Consult||
1551|076|P|your doctor before breastfeeding.||
1551|077|B|||
1551|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1551|079|I|medications work or increase your risk for serious side effects.||
1551|080|I|This document does not contain all possible drug interactions.||
1551|081|I|Keep a list of all the products you use (including||
1551|082|I|prescription/nonprescription drugs and herbal products) and share||
1551|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
1551|084|I|the dosage of any medicines without your doctor's approval.||
1551|085|B|||
1551|086|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1551|087|O|has overdosed and has serious symptoms such as passing out or||
1551|088|O|trouble breathing, call 911. Otherwise, call a poison control||
1551|089|O|center right away. US residents can call 1-800-222-1222. Canada||
1551|090|O|residents can call 1-844-764-7669.||
1551|091|B|||
1551|092|N|NOTES:  Do not share this medication with others.||
1551|093|N|   This medication has been prescribed for your current condition||
1551|094|N|only. Do not use it later for another infection unless your||
1551|095|N|doctor tells you to.||
1551|096|B|||
1551|097|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1551|098|D|If it is near the time of the next dose, skip the missed dose.||
1551|099|D|Use your next dose at the regular time. Do not double the dose to||
1551|100|D|catch up.||
1551|101|B|||
1551|102|R|STORAGE:  Store at room temperature. Keep all medications away||
1551|103|R|from children and pets.||
1551|104|R|   Do not flush medications down the toilet or pour them into a||
1551|105|R|drain unless instructed to do so. Properly discard this product||
1551|106|R|when it is expired or no longer needed. Consult your pharmacist||
1551|107|R|or local waste disposal company.||
1551|108|B|||
1551|109|A|Information last revised October 2024.||
1551|110|A|Copyright(c) 2025 First Databank, Inc.||
1551|111|B|||
1552|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1552|002|Z|does NOT have all possible information about this product. This||
1552|003|Z|information does not assure that this product is safe, effective,||
1552|004|Z|or appropriate for you. This information is not individual||
1552|005|Z|medical advice and does not substitute for the advice of your||
1552|006|Z|health care professional. Always ask your health care||
1552|007|Z|professional for complete information about this product and your||
1552|008|Z|specific health needs.||
1552|009|B|||
1552|010|T|TRIFLURIDINE/TIPIRACIL - ORAL||
1552|011|F|(trye-FLURE-i-deen/tye-PIR-a-sil)||
1552|012|B|||
1552|013|C|COMMON BRAND NAME(S): Lonsurf||
1552|014|B|||
1552|015|U|USES:  This medication is used to treat certain cancers (such as||
1552|016|U|stomach, colon/rectum). It works by slowing or stopping the||
1552|017|U|growth of cancer cells.||
1552|018|B|||
1552|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1552|020|H|from your pharmacist before you start taking this medication and||
1552|021|H|each time you get a refill. If you have any questions, ask your||
1552|022|H|doctor or pharmacist.||
1552|023|H|   This drug is not taken every day. On the days you are supposed||
1552|024|H|to take this medication, take it by mouth as directed by your||
1552|025|H|doctor, usually twice in one day. Take your dose within 1 hour||
1552|026|H|after eating your morning and evening meals. Swallow the tablets||
1552|027|H|whole. Do not crush or chew. Follow your doctor's directions||
1552|028|H|exactly.||
1552|029|H|   The dosage is based on your body size, medical condition, and||
1552|030|H|response to treatment. Do not increase your dose or use this drug||
1552|031|H|more often or for longer than prescribed. Your condition will not||
1552|032|H|improve any faster, and your risk of side effects will increase.||
1552|033|H|   Take this medication regularly to get the most benefit from||
1552|034|H|it. To help you remember, take it at the same times on the days||
1552|035|H|your doctor directs.||
1552|036|H|   If you vomit after taking a dose, do not take another dose at||
1552|037|H|that time. Take your next dose at the regular time.||
1552|038|H|   Since this drug can be absorbed through the skin and lungs and||
1552|039|H|may harm an unborn baby, women who are pregnant or who may become||
1552|040|H|pregnant should not handle this medication or breathe the dust||
1552|041|H|from the tablets. You and your caregiver should wear gloves when||
1552|042|H|handling this medication. Wash your hands after handling the||
1552|043|H|tablets.||
1552|044|B|||
1552|045|S|SIDE EFFECTS:  Nausea, diarrhea, vomiting, change in taste, or||
1552|046|S|hair loss may occur. If any of these effects last or get worse,||
1552|047|S|tell your doctor or pharmacist promptly.||
1552|048|S|   People using this medication may have serious side effects.||
1552|049|S|However, you have been prescribed this drug because your doctor||
1552|050|S|has judged that the benefit to you is greater than the risk of||
1552|051|S|side effects. Careful monitoring by your doctor may decrease your||
1552|052|S|risk.||
1552|053|S|   This medication decreases bone marrow function, an effect that||
1552|054|S|may lead to a low number of blood cells such as red cells, white||
1552|055|S|cells, and platelets. This effect can cause anemia, decrease your||
1552|056|S|body's ability to fight an infection, or cause easy||
1552|057|S|bruising/bleeding. Tell your doctor right away if you develop any||
1552|058|S|of the following symptoms: unusual tiredness, pale skin, signs of||
1552|059|S|infection (such as sore throat that doesn't go away, fever,||
1552|060|S|chills), easy bruising/bleeding.||
1552|061|S|   Get medical help right away if you have any very serious side||
1552|062|S|effects, including: chest pain, trouble breathing.||
1552|063|S|   A very serious allergic reaction to this drug is rare.||
1552|064|S|However, get medical help right away if you notice any symptoms||
1552|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1552|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1552|067|S|breathing.||
1552|068|S|   This is not a complete list of possible side effects. If you||
1552|069|S|notice other effects not listed above, contact your doctor or||
1552|070|S|pharmacist.||
1552|071|S|   In the US -||
1552|072|S|   Call your doctor for medical advice about side effects. You||
1552|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1552|074|S|www.fda.gov/medwatch.||
1552|075|S|   In Canada - Call your doctor for medical advice about side||
1552|076|S|effects. You may report side effects to Health Canada at||
1552|077|S|1-866-234-2345.||
1552|078|B|||
1552|079|P|PRECAUTIONS:  Before taking trifluridine/tipiracil, tell your||
1552|080|P|doctor or pharmacist if you are allergic to it; or if you have||
1552|081|P|any other allergies. This product may contain inactive||
1552|082|P|ingredients, which can cause allergic reactions or other||
1552|083|P|problems. Talk to your pharmacist for more details.||
1552|084|P|   Before using this medication, tell your doctor or pharmacist||
1552|085|P|your medical history, especially of: kidney problems, liver||
1552|086|P|problems.||
1552|087|P|   Before having surgery, tell your doctor or dentist about all||
1552|088|P|the products you use (including prescription drugs,||
1552|089|P|nonprescription drugs, and herbal products).||
1552|090|P|   This product can make you more likely to get infections or may||
1552|091|P|make current infections worse. Stay away from anyone who has an||
1552|092|P|infection that may easily spread (such as chickenpox, COVID-19,||
1552|093|P|measles, flu). Talk to your doctor if you have been exposed to an||
1552|094|P|infection or for more details.||
1552|095|P|   Tell your health care professional that you are using||
1552|096|P|trifluridine/tipiracil before having any||
1552|097|P|immunizations/vaccinations. Avoid contact with people who have||
1552|098|P|recently received live vaccines (such as flu vaccine inhaled||
1552|099|P|through the nose).||
1552|100|P|   To lower the chance of getting cut, bruised, or injured, use||
1552|101|P|caution with sharp objects like razors and nail cutters, and||
1552|102|P|avoid activities such as contact sports.||
1552|103|P|   Older adults may be more sensitive to the side effects of this||
1552|104|P|drug, especially decreased bone marrow function.||
1552|105|P|   Tell your doctor if you are pregnant or plan to become||
1552|106|P|pregnant. You should not become pregnant while using||
1552|107|P|trifluridine/tipiracil. Trifluridine/tipiracil may harm an unborn||
1552|108|P|baby. Your doctor should order a pregnancy test before you start||
1552|109|P|this medication. Men and women using this medication should ask||
1552|110|P|about reliable forms of birth control during treatment and for 6||
1552|111|P|months after the last dose. Men taking this medication should use||
1552|112|P|condoms during sex with women who are pregnant or of childbearing||
1552|113|P|age. If you or your partner becomes pregnant, talk to your doctor||
1552|114|P|right away about the risks and benefits of this medication.||
1552|115|P|   It is unknown if this medication passes into breast milk.||
1552|116|P|Because of the possible risk to the infant, breastfeeding is not||
1552|117|P|recommended while using this medication and for one day after the||
1552|118|P|last dose. Consult your doctor before breastfeeding.||
1552|119|B|||
1552|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1552|121|I|medications work or increase your risk for serious side effects.||
1552|122|I|This document does not contain all possible drug interactions.||
1552|123|I|Keep a list of all the products you use (including||
1552|124|I|prescription/nonprescription drugs and herbal products) and share||
1552|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1552|126|I|the dosage of any medicines without your doctor's approval.||
1552|127|B|||
1552|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1552|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1552|130|O|poison control center right away. US residents can call||
1552|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1552|132|B|||
1552|133|N|NOTES:  Do not share this medication with others.||
1552|134|N|   Lab and/or medical tests (such as complete blood counts) must||
1552|135|N|be done while you are taking this medication. Keep all medical||
1552|136|N|and lab appointments. Consult your doctor for more details.||
1552|137|B|||
1552|138|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1552|139|D|next dose at the regular time. Do not double the dose to catch||
1552|140|D|up.||
1552|141|B|||
1552|142|R|STORAGE:  Store in the original bottle at room temperature away||
1552|143|R|from light and moisture. If stored outside of the original||
1552|144|R|bottle, this medication expires after 30 days. Do not store in||
1552|145|R|the bathroom. Keep all medications away from children and pets.||
1552|146|R|   Do not flush medications down the toilet or pour them into a||
1552|147|R|drain unless instructed to do so. Properly discard this product||
1552|148|R|when it is expired or no longer needed. Consult your pharmacist||
1552|149|R|or local waste disposal company.||
1552|150|B|||
1552|151|M|MEDICAL ALERT:  Your condition can cause complications in a||
1552|152|M|medical emergency. For information about enrolling in MedicAlert,||
1552|153|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1552|154|B|||
1552|155|A|Information last revised July 2024.||
1552|156|A|Copyright(c) 2025 First Databank, Inc.||
1552|157|B|||
1553|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1553|002|Z|does NOT have all possible information about this product. This||
1553|003|Z|information does not assure that this product is safe, effective,||
1553|004|Z|or appropriate for you. This information is not individual||
1553|005|Z|medical advice and does not substitute for the advice of your||
1553|006|Z|health care professional. Always ask your health care||
1553|007|Z|professional for complete information about this product and your||
1553|008|Z|specific health needs.||
1553|009|B|||
1553|010|T|GOLIMUMAB - INJECTION||
1553|011|F|(goe-LIM-ue-mab)||
1553|012|B|||
1553|013|C|COMMON BRAND NAME(S): Simponi Aria||
1553|014|B|||
1553|015|W|WARNING:  This medication can decrease your body's ability to||
1553|016|W|fight an infection. This effect can lead to very serious||
1553|017|W|(possibly fatal) infections (such as fungal infections, bacterial||
1553|018|W|infections including tuberculosis). Tell your doctor your medical||
1553|019|W|history, especially of past/recent/current infections. You should||
1553|020|W|also tell your doctor if you have lived or traveled in areas||
1553|021|W|where certain fungal infections (such as coccidioidomycosis,||
1553|022|W|histoplasmosis) are common or if you have been near someone with||
1553|023|W|tuberculosis. Areas where these types of fungal infections are||
1553|024|W|commonly found include the Ohio and Mississippi River valleys and||
1553|025|W|the southwestern United States.||
1553|026|W|   Your doctor will test you for tuberculosis (TB) infection||
1553|027|W|before and during treatment with this drug. If you are diagnosed||
1553|028|W|with TB, your doctor will first prescribe treatment for this to||
1553|029|W|prevent a serious TB infection while using golimumab.||
1553|030|W|   Though it is very unlikely to happen, there is a risk||
1553|031|W|(especially in children/teens/young adults) of developing cancer||
1553|032|W|(such as lymphoma, skin cancer) due to this medication or due to||
1553|033|W|your medical condition. Discuss the risks and benefits of||
1553|034|W|treatment with your doctor. Tell your doctor right away if you||
1553|035|W|develop symptoms such as fever that doesn't go away, unusual||
1553|036|W|lumps/growths, swollen lymph nodes, unexplained weight loss, or||
1553|037|W|night sweats.||
1553|038|B|||
1553|039|U|USES:  This medication is used to treat certain types of||
1553|040|U|arthritis (such as rheumatoid arthritis, psoriatic arthritis,||
1553|041|U|polyarticular juvenile idiopathic arthritis, ankylosing||
1553|042|U|spondylitis). Golimumab belongs to a class of drugs known as TNF||
1553|043|U|blockers. It works by blocking a protein (tumor necrosis factor -||
1553|044|U|TNF) in your body's immune system that causes joint swelling and||
1553|045|U|damage. Golimumab helps slow joint damage and reduce joint||
1553|046|U|pain/swelling so you can move better.||
1553|047|B|||
1553|048|H|HOW TO USE:  Read the Medication Guide provided by your||
1553|049|H|pharmacist before you start using golimumab and each time you get||
1553|050|H|a refill. If you have any questions, ask your doctor or||
1553|051|H|pharmacist.||
1553|052|H|   This drug is given by slow injection into a vein by a health||
1553|053|H|care professional, usually over 30 minutes. After the first dose,||
1553|054|H|this medication is usually given again 4 weeks later, then every||
1553|055|H|8 weeks as directed by your doctor. The dosage is based on your||
1553|056|H|weight. Children's dosage is based on body size.||
1553|057|H|   Use this medication regularly to get the most benefit from it.||
1553|058|H|To help you remember, mark your calendar with a reminder.||
1553|059|H|   Tell your doctor if your symptoms do not get better or if they||
1553|060|H|get worse.||
1553|061|B|||
1553|062|S|SIDE EFFECTS:  See also Warning section.||
1553|063|S|   Redness, irritation, or pain at the injection site may occur.||
1553|064|S|If any of these effects last or get worse, tell your doctor or||
1553|065|S|pharmacist promptly.||
1553|066|S|   Remember that this medication has been prescribed because your||
1553|067|S|doctor has judged that the benefit to you is greater than the||
1553|068|S|risk of side effects. Many people using this medication do not||
1553|069|S|have serious side effects.||
1553|070|S|   Tell your doctor right away if you have any serious side||
1553|071|S|effects, including: easy bruising/bleeding, numbness/tingling of||
1553|072|S|the hands/feet, unsteadiness, unexplained muscle weakness, vision||
1553|073|S|changes, muscle/joint pain, butterfly-shaped rash on the nose and||
1553|074|S|cheeks, symptoms of heart failure (including shortness of breath,||
1553|075|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
1553|076|S|gain), signs of infection (such as sore throat that doesn't go||
1553|077|S|away, fever, chills, unusual sweating), symptoms of liver damage||
1553|078|S|(including nausea/vomiting that doesn't stop, loss of appetite,||
1553|079|S|dark urine, stomach/abdominal pain, yellow eyes/skin).||
1553|080|S|   Get medical help right away if you have any very serious side||
1553|081|S|effects, including: chest pain, seizures.||
1553|082|S|   Golimumab can commonly cause a rash that is usually not||
1553|083|S|serious. However, you may not be able to tell it apart from a||
1553|084|S|rare rash that could be a sign of a severe reaction. Get medical||
1553|085|S|help right away if you develop any rash.||
1553|086|S|   A very serious allergic reaction to this drug is rare.||
1553|087|S|However, get medical help right away if you notice any symptoms||
1553|088|S|of a serious allergic reaction, including: rash, itching/swelling||
1553|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1553|090|S|breathing.||
1553|091|S|   This is not a complete list of possible side effects. If you||
1553|092|S|notice other effects not listed above, contact your doctor or||
1553|093|S|pharmacist.||
1553|094|S|   In the US -||
1553|095|S|   Call your doctor for medical advice about side effects. You||
1553|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1553|097|S|www.fda.gov/medwatch.||
1553|098|S|   In Canada - Call your doctor for medical advice about side||
1553|099|S|effects. You may report side effects to Health Canada at||
1553|100|S|1-866-234-2345.||
1553|101|B|||
1553|102|P|PRECAUTIONS:  See also Warning section.||
1553|103|P|   Before using golimumab, tell your doctor or pharmacist if you||
1553|104|P|are allergic to it; or if you have any other allergies. This||
1553|105|P|product may contain inactive ingredients, which can cause||
1553|106|P|allergic reactions or other problems. Talk to your pharmacist for||
1553|107|P|more details.||
1553|108|P|   Before using this medication, tell your doctor or pharmacist||
1553|109|P|your medical history, especially of: blood/bone marrow problems||
1553|110|P|(such as low red/white blood cells and platelets), certain||
1553|111|P|brain/nerve disorders (such as multiple sclerosis, Guillain-Barre||
1553|112|P|syndrome), cancer, current/recent/repeated infections (such as||
1553|113|P|fungal, hepatitis B, tuberculosis), heart disease (such as heart||
1553|114|P|failure), lupus, seizures.||
1553|115|P|   Golimumab can make you more likely to get infections or may||
1553|116|P|make current infections worse. Stay away from anyone who has an||
1553|117|P|infection that may easily spread (such as chickenpox, COVID-19,||
1553|118|P|measles, flu). Talk to your doctor if you have been exposed to an||
1553|119|P|infection or for more details.||
1553|120|P|   Tell your health care professional that you are using||
1553|121|P|golimumab before having any immunizations/vaccinations. Avoid||
1553|122|P|contact with people who have recently received live vaccines||
1553|123|P|(such as flu vaccine inhaled through the nose).||
1553|124|P|   To lower the chance of getting cut, bruised, or injured, use||
1553|125|P|caution with sharp objects like razors and nail cutters, and||
1553|126|P|avoid activities such as contact sports.||
1553|127|P|   Before having surgery, tell your doctor or dentist about all||
1553|128|P|the products you use (including prescription drugs,||
1553|129|P|nonprescription drugs, and herbal products).||
1553|130|P|   Older adults may be more sensitive to the side effects of this||
1553|131|P|drug, especially the risk of infections.||
1553|132|P|   During pregnancy, this medication should be used only when||
1553|133|P|clearly needed. Discuss the risks and benefits with your doctor.||
1553|134|P|Mothers who have used this medication during pregnancy should ask||
1553|135|P|a doctor about immunizations/vaccinations for their newborn||
1553|136|P|babies.||
1553|137|P|   This medication passes into breast milk. Consult your doctor||
1553|138|P|before breastfeeding.||
1553|139|B|||
1553|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1553|141|I|medications work or increase your risk for serious side effects.||
1553|142|I|This document does not contain all possible drug interactions.||
1553|143|I|Keep a list of all the products you use (including||
1553|144|I|prescription/nonprescription drugs and herbal products) and share||
1553|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
1553|146|I|the dosage of any medicines without your doctor's approval.||
1553|147|I|   Some products that may interact with this drug include: other||
1553|148|I|TNF-blockers (such as adalimumab, certolizumab, etanercept,||
1553|149|I|infliximab), other drugs that weaken the immune system (such as||
1553|150|I|abatacept, anakinra, cyclosporine).||
1553|151|I|   Avoid treatments that contain live bacteria or viruses (such||
1553|152|I|as BCG, flu vaccine inhaled through the nose) since they may||
1553|153|I|increase your risk for serious infections while you are using||
1553|154|I|golimumab.||
1553|155|B|||
1553|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1553|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1553|158|O|poison control center right away. US residents can call||
1553|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1553|160|B|||
1553|161|N|NOTES:  Do not share this medication with others.||
1553|162|N|   Lab and/or medical tests (such as complete blood counts, liver||
1553|163|N|function, skin exams, TB/hepatitis B tests) should be done before||
1553|164|N|you start using this medication and while you are using it. Keep||
1553|165|N|all medical and lab appointments. Consult your doctor for more||
1553|166|N|details.||
1553|167|B|||
1553|168|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
1553|169|D|right away for a new dosing schedule.||
1553|170|B|||
1553|171|R|STORAGE:  Not applicable. This medication is given in a hospital||
1553|172|R|or clinic and will not be stored at home.||
1553|173|B|||
1553|174|M|MEDICAL ALERT:  Your condition can cause complications in a||
1553|175|M|medical emergency. For information about enrolling in MedicAlert,||
1553|176|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1553|177|B|||
1553|178|A|Information last revised November 2025.||
1553|179|A|Copyright(c) 2025 First Databank, Inc.||
1553|180|B|||
1554|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1554|002|Z|does NOT have all possible information about this product. This||
1554|003|Z|information does not assure that this product is safe, effective,||
1554|004|Z|or appropriate for you. This information is not individual||
1554|005|Z|medical advice and does not substitute for the advice of your||
1554|006|Z|health care professional. Always ask your health care||
1554|007|Z|professional for complete information about this product and your||
1554|008|Z|specific health needs.||
1554|009|B|||
1554|010|T|PAROXETINE 7.5 MG - ORAL||
1554|011|F|(pa-ROX-e-teen)||
1554|012|B|||
1554|013|C|COMMON BRAND NAME(S): Brisdelle||
1554|014|B|||
1554|015|W|WARNING:  Antidepressant medications, including paroxetine, are||
1554|016|W|used to treat a variety of conditions, including depression and||
1554|017|W|other mental/mood disorders. These medications can help prevent||
1554|018|W|suicidal thoughts/attempts and provide other important benefits.||
1554|019|W|However, studies have shown that a small number of people||
1554|020|W|(especially people younger than 25) who take antidepressants for||
1554|021|W|any condition may experience worsening depression, other||
1554|022|W|mental/mood symptoms, or suicidal thoughts/attempts. It is very||
1554|023|W|important to talk with the doctor about the risks and benefits of||
1554|024|W|this medication (especially for people younger than 25), even if||
1554|025|W|treatment is not for a mental/mood condition.||
1554|026|W|   Tell the doctor right away if you notice worsening||
1554|027|W|depression/other psychiatric conditions, unusual behavior changes||
1554|028|W|(including possible suicidal thoughts/attempts), or other||
1554|029|W|mental/mood changes (including new/worsening anxiety, panic||
1554|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1554|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
1554|032|W|especially watchful for these symptoms when paroxetine is started||
1554|033|W|or when the dose is changed.||
1554|034|B|||
1554|035|U|USES:  This medication is used to treat hot flashes that occur||
1554|036|U|with menopause. Paroxetine belongs to a class of drugs known as||
1554|037|U|selective serotonin reuptake inhibitors (SSRIs).||
1554|038|B|||
1554|039|H|HOW TO USE:  Read the Medication Guide provided by your||
1554|040|H|pharmacist before you start taking paroxetine and each time you||
1554|041|H|get a refill. If you have any questions, ask your doctor or||
1554|042|H|pharmacist.||
1554|043|H|   There are different brands of this medication available. Do||
1554|044|H|not change brands without asking your doctor or pharmacist.||
1554|045|H|   Take this medication by mouth with or without food as directed||
1554|046|H|by your doctor, usually once daily at bedtime.||
1554|047|H|   Use this medication regularly to get the most benefit from it.||
1554|048|H|To help you remember, take it at the same time each day.||
1554|049|H|   Keep taking this medication even if you feel well. Do not stop||
1554|050|H|taking this medication without consulting your doctor. Some||
1554|051|H|conditions may become worse when this drug is suddenly stopped.||
1554|052|H|Also, you may experience symptoms such as mood swings, headache,||
1554|053|H|tiredness, sleep changes, and brief feelings similar to electric||
1554|054|H|shock. To prevent these symptoms while you are stopping treatment||
1554|055|H|with this drug, your doctor may reduce your dose gradually.||
1554|056|H|Consult your doctor or pharmacist for more details. Report any||
1554|057|H|new or worsening symptoms right away.||
1554|058|H|   Tell your doctor if your condition does not get better or if||
1554|059|H|it gets worse.||
1554|060|B|||
1554|061|S|SIDE EFFECTS:  See also Warning section.||
1554|062|S|   Nausea, vomiting, drowsiness, dizziness, trouble sleeping,||
1554|063|S|loss of appetite, weakness, dry mouth, sweating, blurred vision,||
1554|064|S|and yawning may occur. If any of these effects last or get worse,||
1554|065|S|tell your doctor or pharmacist promptly.||
1554|066|S|   Remember that this medication has been prescribed because your||
1554|067|S|doctor has judged that the benefit to you is greater than the||
1554|068|S|risk of side effects. Many people using this medication do not||
1554|069|S|have serious side effects.||
1554|070|S|   Tell your doctor right away if you have any serious side||
1554|071|S|effects, including: shakiness (tremor), restlessness, inability||
1554|072|S|to keep still, decreased interest in sex, changes in sexual||
1554|073|S|ability, numbness/tingling, easy bleeding/bruising,||
1554|074|S|fast/irregular heartbeat, muscle weakness/spasm, mental/mood||
1554|075|S|changes (such as difficulty concentrating, confusion).||
1554|076|S|   Get medical help right away if you have any very serious side||
1554|077|S|effects, including: seizures, black stools, vomit that looks like||
1554|078|S|coffee grounds, eye pain/swelling/redness, widened pupils, vision||
1554|079|S|changes (such as seeing rainbows around lights at night).||
1554|080|S|   This medication may increase serotonin and rarely cause a very||
1554|081|S|serious condition called serotonin syndrome/toxicity. The risk||
1554|082|S|increases if you are also taking other drugs that increase||
1554|083|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1554|084|S|take (see Drug Interactions section). Get medical help right away||
1554|085|S|if you develop some of the following symptoms: fast heartbeat,||
1554|086|S|hallucinations, loss of coordination, severe dizziness, severe||
1554|087|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1554|088|S|unusual agitation/restlessness.||
1554|089|S|   When used by men, paroxetine may rarely cause a painful or||
1554|090|S|prolonged erection lasting 4 or more hours. If this occurs, stop||
1554|091|S|using this drug and get medical help right away, or permanent||
1554|092|S|problems could occur.||
1554|093|S|   A very serious allergic reaction to this drug is rare.||
1554|094|S|However, get medical help right away if you notice any symptoms||
1554|095|S|of a serious allergic reaction, including: rash, itching/swelling||
1554|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1554|097|S|breathing.||
1554|098|S|   This is not a complete list of possible side effects. If you||
1554|099|S|notice other effects not listed above, contact your doctor or||
1554|100|S|pharmacist.||
1554|101|S|   In the US -||
1554|102|S|   Call your doctor for medical advice about side effects. You||
1554|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1554|104|S|www.fda.gov/medwatch.||
1554|105|S|   In Canada - Call your doctor for medical advice about side||
1554|106|S|effects. You may report side effects to Health Canada at||
1554|107|S|1-866-234-2345.||
1554|108|B|||
1554|109|P|PRECAUTIONS:  Before taking paroxetine, tell your doctor or||
1554|110|P|pharmacist if you are allergic to it; or if you have any other||
1554|111|P|allergies. This product may contain inactive ingredients, which||
1554|112|P|can cause allergic reactions or other problems. Talk to your||
1554|113|P|pharmacist for more details.||
1554|114|P|   Before using this medication, tell your doctor or pharmacist||
1554|115|P|your medical history, especially of: personal or family history||
1554|116|P|of bipolar/manic-depressive disorder, personal or family history||
1554|117|P|of suicide attempts, liver problems, kidney problems, low sodium||
1554|118|P|in the blood, seizures, bleeding problems, personal or family||
1554|119|P|history of glaucoma (angle-closure type).||
1554|120|P|   This drug may make you dizzy or drowsy or blur your vision.||
1554|121|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1554|122|P|drowsy. Do not drive, use machinery, or do anything that needs||
1554|123|P|alertness or clear vision until you can do it safely. Avoid||
1554|124|P|alcoholic beverages. Talk to your doctor if you are using||
1554|125|P|marijuana (cannabis).||
1554|126|P|   Before having surgery, tell your doctor or dentist about all||
1554|127|P|the products you use (including prescription drugs,||
1554|128|P|nonprescription drugs, and herbal products).||
1554|129|P|   Older adults may be more sensitive to the side effects of this||
1554|130|P|drug, especially bleeding or loss of coordination. Older adults||
1554|131|P|may also be more likely to develop a type of salt imbalance||
1554|132|P|(hyponatremia), especially if they are also taking "water pills"||
1554|133|P|(diuretics). Loss of coordination can increase the risk of||
1554|134|P|falling.||
1554|135|P|   If this medication is used by children, they may be more||
1554|136|P|sensitive to the side effects of this drug, especially loss of||
1554|137|P|appetite and weight loss. Monitor weight and height in children||
1554|138|P|who are taking this drug.||
1554|139|P|   This medication is not usually used by women of childbearing||
1554|140|P|age. However, if you are prescribed this medication for another||
1554|141|P|use besides menopausal symptoms (see Other Uses section), do not||
1554|142|P|stop taking it unless directed by your doctor. Some conditions||
1554|143|P|may become worse when this drug is suddenly stopped. Paroxetine||
1554|144|P|is not recommended for use during pregnancy. It may harm an||
1554|145|P|unborn baby. If you become pregnant, or think you may be||
1554|146|P|pregnant, immediately discuss with your doctor the benefits and||
1554|147|P|risks of using this medication during pregnancy. Babies born to||
1554|148|P|mothers who have used this drug during the last 3 months of||
1554|149|P|pregnancy may rarely develop withdrawal symptoms such as||
1554|150|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
1554|151|P|constant crying. If you notice any of these symptoms in your||
1554|152|P|newborn, tell the doctor promptly.||
1554|153|P|   This drug passes into breast milk. Consult your doctor before||
1554|154|P|breastfeeding.||
1554|155|B|||
1554|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1554|157|I|medications work or increase your risk for serious side effects.||
1554|158|I|This document does not contain all possible drug interactions.||
1554|159|I|Keep a list of all the products you use (including||
1554|160|I|prescription/nonprescription drugs and herbal products) and share||
1554|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
1554|162|I|the dosage of any medicines without your doctor's approval.||
1554|163|I|   Some products that may interact with this drug are:||
1554|164|I|thioridazine, other drugs that can cause bleeding/bruising||
1554|165|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
1554|166|I|ibuprofen/naproxen, "blood thinners" such as||
1554|167|I|dabigatran/warfarin).||
1554|168|I|   Aspirin can increase the risk of bleeding when used with this||
1554|169|I|medication. However, if your doctor has told you to take low-dose||
1554|170|I|aspirin to prevent heart attack or stroke (usually 81-162||
1554|171|I|milligrams a day), you should keep taking the aspirin unless your||
1554|172|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1554|173|I|details.||
1554|174|I|   This medication can slow down the removal of other medications||
1554|175|I|from your body, which may affect how they work. Examples of||
1554|176|I|affected drugs include phenothiazines, pimozide, tamoxifen,||
1554|177|I|antiarrhythmics such as propafenone/flecainide, among others.||
1554|178|I|   Taking MAO inhibitors with this medication may cause a serious||
1554|179|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1554|180|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1554|181|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1554|182|I|selegiline, tranylcypromine) during treatment with this||
1554|183|I|medication. Most MAO inhibitors should also not be taken for two||
1554|184|I|weeks before and after treatment with this medication. Ask your||
1554|185|I|doctor when to start or stop taking this medication.||
1554|186|I|   The risk of serotonin syndrome/toxicity increases if you are||
1554|187|I|also taking other drugs that increase serotonin. Examples include||
1554|188|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1554|189|I|antidepressants (including other SSRIs such as||
1554|190|I|citalopram/fluoxetine, SNRIs such as duloxetine/venlafaxine),||
1554|191|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
1554|192|I|may be more likely when you start or increase the dose of these||
1554|193|I|drugs.||
1554|194|I|   Tell your doctor or pharmacist if you are taking other||
1554|195|I|products that cause drowsiness including alcohol, marijuana||
1554|196|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1554|197|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1554|198|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1554|199|I|codeine).||
1554|200|I|   Check the labels on all your medicines (such as allergy or||
1554|201|I|cough-and-cold products) because they may contain ingredients||
1554|202|I|that cause drowsiness. Ask your pharmacist about using those||
1554|203|I|products safely.||
1554|204|I|   This medication may interfere with certain medical/lab tests||
1554|205|I|(such as brain scan for Parkinson's disease), possibly causing||
1554|206|I|false test results. Make sure lab personnel and all your doctors||
1554|207|I|know you use this drug.||
1554|208|B|||
1554|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1554|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1554|211|O|poison control center right away. US residents can call||
1554|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1554|213|O|Symptoms of overdose may include: irregular heartbeat, fainting,||
1554|214|O|severe dizziness, seizures.||
1554|215|B|||
1554|216|N|NOTES:  Do not share this medication with others.||
1554|217|N|   Keep all medical and lab appointments.||
1554|218|B|||
1554|219|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1554|220|D|remember. If it is near the time of the next dose, skip the||
1554|221|D|missed dose. Take your next dose at the regular time. Do not||
1554|222|D|double the dose to catch up.||
1554|223|B|||
1554|224|R|STORAGE:  Store at room temperature away from light and moisture.||
1554|225|R|Do not store in the bathroom. Keep all medications away from||
1554|226|R|children and pets.||
1554|227|R|   Do not flush medications down the toilet or pour them into a||
1554|228|R|drain unless instructed to do so. Properly discard this product||
1554|229|R|when it is expired or no longer needed. Consult your pharmacist||
1554|230|R|or local waste disposal company.||
1554|231|B|||
1554|232|A|Information last revised February 2025.||
1554|233|A|Copyright(c) 2025 First Databank, Inc.||
1554|234|B|||
1556|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1556|002|Z|does NOT have all possible information about this product. This||
1556|003|Z|information does not assure that this product is safe, effective,||
1556|004|Z|or appropriate for you. This information is not individual||
1556|005|Z|medical advice and does not substitute for the advice of your||
1556|006|Z|health care professional. Always ask your health care||
1556|007|Z|professional for complete information about this product and your||
1556|008|Z|specific health needs.||
1556|009|B|||
1556|010|T|FERRIC CARBOXYMALTOSE - INJECTION||
1556|011|F|(FER-ik kar-BOX-ee-MAWL-tose)||
1556|012|B|||
1556|013|C|COMMON BRAND NAME(S): Injectafer||
1556|014|B|||
1556|015|U|USES:  This medication is used to treat "iron-poor" blood (iron||
1556|016|U|deficiency anemia). Low iron levels can occur due to many||
1556|017|U|conditions, including when your body cannot get enough iron from||
1556|018|U|food (because of poor nutrition or poor absorption) or when there||
1556|019|U|is long-term blood loss. Ferric carboxymaltose is a form of||
1556|020|U|injectable iron that is used if you cannot take iron by mouth||
1556|021|U|because of side effects or an unsuccessful response to treatment.||
1556|022|U|It is also used by people who have anemia due to long-term kidney||
1556|023|U|disease or heart failure.||
1556|024|U|   Iron is an important mineral that your body needs to make||
1556|025|U|enough healthy red blood cells to carry oxygen throughout your||
1556|026|U|body.||
1556|027|B|||
1556|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1556|029|H|from your pharmacist before you start using ferric carboxymaltose||
1556|030|H|and with each treatment. If you have any questions, ask your||
1556|031|H|doctor or pharmacist.||
1556|032|H|   This medication is given by injection into a vein, usually by||
1556|033|H|a health care professional, as directed by your doctor. It is||
1556|034|H|usually given slowly over several minutes. It can also be mixed||
1556|035|H|in a saline solution and given by infusion into a vein over at||
1556|036|H|least 15 minutes.||
1556|037|H|   The dosage is based on your medical condition, weight, lab||
1556|038|H|tests and response to treatment.||
1556|039|H|   If you are using this medication at home, learn all||
1556|040|H|preparation and usage instructions from your health care||
1556|041|H|professional. Before using, check this product for particles or||
1556|042|H|discoloration. If either is present, do not use the liquid. Learn||
1556|043|H|how to store and discard medical supplies safely.||
1556|044|B|||
1556|045|S|SIDE EFFECTS:  Flushing, nausea, dizziness, or||
1556|046|S|pain/irritation/bruising at the injection site may occur. Brown||
1556|047|S|staining of the skin around the injection site may also occur and||
1556|048|S|can be long lasting. If any of these effects last or get worse,||
1556|049|S|tell your doctor or pharmacist promptly.||
1556|050|S|   Remember that this medication has been prescribed because your||
1556|051|S|doctor has judged that the benefit to you is greater than the||
1556|052|S|risk of side effects. Many people using this medication do not||
1556|053|S|have serious side effects.||
1556|054|S|   An increase in your blood pressure, sometimes along with||
1556|055|S|dizziness, nausea, or flushing of the face, may rarely occur||
1556|056|S|right after a dose of this medication, but these effects usually||
1556|057|S|go away within 30 minutes. Tell your doctor right away if your||
1556|058|S|blood pressure remains high or if these symptoms last or get||
1556|059|S|worse.||
1556|060|S|   Tell your doctor right away if you have any serious side||
1556|061|S|effects, including: bone pain/problems, symptoms of low phosphate||
1556|062|S|levels (such as muscle weakness, mental/mood changes).||
1556|063|S|   A rare but very serious, possibly fatal, allergic reaction may||
1556|064|S|occur with this medication. You should be monitored during the||
1556|065|S|dose and for at least 30 minutes afterwards. Get medical help||
1556|066|S|right away if you notice any symptoms of a serious allergic||
1556|067|S|reaction, including: rash, itching/swelling (especially of the||
1556|068|S|face/tongue/throat), severe dizziness, trouble breathing, loss of||
1556|069|S|consciousness.||
1556|070|S|   This is not a complete list of possible side effects. If you||
1556|071|S|notice other effects not listed above, contact your doctor or||
1556|072|S|pharmacist.||
1556|073|S|   In the US -||
1556|074|S|   Call your doctor for medical advice about side effects. You||
1556|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1556|076|S|www.fda.gov/medwatch.||
1556|077|S|   In Canada - Call your doctor for medical advice about side||
1556|078|S|effects. You may report side effects to Health Canada at||
1556|079|S|1-866-234-2345.||
1556|080|B|||
1556|081|P|PRECAUTIONS:  Before using ferric carboxymaltose, tell your||
1556|082|P|doctor or pharmacist if you are allergic to it; or to other iron||
1556|083|P|injection products; or if you have any other allergies. This||
1556|084|P|product may contain inactive ingredients, which can cause||
1556|085|P|allergic reactions or other problems. Talk to your pharmacist for||
1556|086|P|more details.||
1556|087|P|   Before using this medication, tell your doctor or pharmacist||
1556|088|P|your medical history, especially of: liver disease.||
1556|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1556|090|P|can make you more dizzy. Do not drive, use machinery, or do||
1556|091|P|anything that needs alertness until you can do it safely. Limit||
1556|092|P|alcoholic beverages. Talk to your doctor if you are using||
1556|093|P|marijuana (cannabis).||
1556|094|P|   Before having surgery, tell your doctor or dentist about all||
1556|095|P|the products you use (including prescription drugs,||
1556|096|P|nonprescription drugs, and herbal products).||
1556|097|P|   During pregnancy, this medication should be used only when||
1556|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
1556|099|P|   This medication passes into breast milk. Consult your doctor||
1556|100|P|before breastfeeding.||
1556|101|B|||
1556|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1556|103|I|medications work or increase your risk for serious side effects.||
1556|104|I|This document does not contain all possible drug interactions.||
1556|105|I|Keep a list of all the products you use (including||
1556|106|I|prescription/nonprescription drugs and herbal products) and share||
1556|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1556|108|I|the dosage of any medicines without your doctor's approval.||
1556|109|I|   Some products that may interact with this drug include:||
1556|110|I|dimercaprol, other iron-containing products.||
1556|111|B|||
1556|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1556|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1556|114|O|poison control center right away. US residents can call||
1556|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1556|116|B|||
1556|117|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1556|118|N|iron/phosphate levels) should be done while you are using this||
1556|119|N|medication. Keep all medical and lab appointments.||
1556|120|N|   It is important to eat a well-balanced diet that has enough||
1556|121|N|iron, vitamins, and minerals. Good sources of iron include meats||
1556|122|N|(especially liver), eggs, raisins, figs, broccoli, brussels||
1556|123|N|sprouts, beans, lentils, and iron-fortified or enriched cereals.||
1556|124|N|Follow any diet recommendations given to you by your doctor.||
1556|125|B|||
1556|126|D|MISSED DOSE:  It is important to get each dose of this medication||
1556|127|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1556|128|D|right away for a new dosing schedule. Do not double the dose to||
1556|129|D|catch up.||
1556|130|B|||
1556|131|R|STORAGE:  Consult the product instructions and your pharmacist||
1556|132|R|for storage details. Keep all medications away from children and||
1556|133|R|pets.||
1556|134|R|   Do not flush medications down the toilet or pour them into a||
1556|135|R|drain unless instructed to do so. Properly discard this product||
1556|136|R|when it is expired or no longer needed. Consult your pharmacist||
1556|137|R|or local waste disposal company.||
1556|138|B|||
1556|139|A|Information last revised November 2024.||
1556|140|A|Copyright(c) 2025 First Databank, Inc.||
1556|141|B|||
1558|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1558|002|Z|does NOT have all possible information about this product. This||
1558|003|Z|information does not assure that this product is safe, effective,||
1558|004|Z|or appropriate for you. This information is not individual||
1558|005|Z|medical advice and does not substitute for the advice of your||
1558|006|Z|health care professional. Always ask your health care||
1558|007|Z|professional for complete information about this product and your||
1558|008|Z|specific health needs.||
1558|009|B|||
1558|010|T|PHENYLEPHRINE - OPHTHALMIC||
1558|011|F|(FEN-il-EF-rin)||
1558|012|B|||
1558|013|C|COMMON BRAND NAME(S): Mydfrin||
1558|014|B|||
1558|015|U|USES:  This medication is used to dilate the pupils for eye||
1558|016|U|examinations or procedures, and to treat certain eye conditions.||
1558|017|U|It belongs to a class of drugs known as decongestants.||
1558|018|U|Phenylephrine works by narrowing blood vessels.||
1558|019|B|||
1558|020|H|HOW TO USE:  To apply eye drops, wash hands first. To avoid||
1558|021|H|contamination, do not touch the dropper tip or let it touch your||
1558|022|H|eye or any other surface.||
1558|023|H|   If you are wearing contact lenses, remove them before using||
1558|024|H|eye drops. Wait at least 15 minutes before replacing your contact||
1558|025|H|lenses. Tilt your head back, look upward, and pull down the lower||
1558|026|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1558|027|H|and place one drop into the pouch. Use as often as directed by||
1558|028|H|your doctor. Look downward, gently close your eyes, and place one||
1558|029|H|finger at the corner of your eye (near the nose). Apply gentle||
1558|030|H|pressure for 1 to 2 minutes before opening your eyes. This will||
1558|031|H|prevent the medication from draining out. Try not to blink or rub||
1558|032|H|your eye. Repeat these steps if your dose is for more than one||
1558|033|H|drop. If directed to use this medication in both eyes, repeat||
1558|034|H|these steps for your other eye. Do not rinse the dropper. Replace||
1558|035|H|the dropper cap after each use.||
1558|036|H|   If you are using another kind of eye medication (such as drops||
1558|037|H|or ointments), wait at least 10 minutes before applying other||
1558|038|H|medications. Use eye drops before eye ointments to allow the||
1558|039|H|drops to enter the eye.||
1558|040|H|   Wait several minutes for your vision to clear before driving||
1558|041|H|or operating machinery.||
1558|042|H|   Use this medication as prescribed to get the most benefit from||
1558|043|H|it.||
1558|044|H|   Tell your doctor if your condition lasts or gets worse.||
1558|045|B|||
1558|046|S|SIDE EFFECTS:  Burning or stinging, headache, sensitivity to||
1558|047|S|light, or blurred vision may occur. If any of these effects last||
1558|048|S|or get worse, tell your doctor or pharmacist promptly.||
1558|049|S|   Remember that this medication has been prescribed because your||
1558|050|S|doctor has judged that the benefit to you is greater than the||
1558|051|S|risk of side effects. Many people using this medication do not||
1558|052|S|have serious side effects.||
1558|053|S|   Tell your doctor right away if you have any serious side||
1558|054|S|effects, including: eye pain, irregular heartbeat.||
1558|055|S|   A very serious allergic reaction to this drug is rare.||
1558|056|S|However, get medical help right away if you notice any symptoms||
1558|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1558|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1558|059|S|breathing.||
1558|060|S|   This is not a complete list of possible side effects. If you||
1558|061|S|notice other effects not listed above, contact your doctor or||
1558|062|S|pharmacist.||
1558|063|S|   In the US -||
1558|064|S|   Call your doctor for medical advice about side effects. You||
1558|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1558|066|S|www.fda.gov/medwatch.||
1558|067|S|   In Canada - Call your doctor for medical advice about side||
1558|068|S|effects. You may report side effects to Health Canada at||
1558|069|S|1-866-234-2345.||
1558|070|B|||
1558|071|P|PRECAUTIONS:  Before using phenylephrine, tell your doctor or||
1558|072|P|pharmacist if you are allergic to it; or if you have any other||
1558|073|P|allergies. This product may contain inactive ingredients (such as||
1558|074|P|sulfites found in some brands), which can cause allergic||
1558|075|P|reactions or other problems. Talk to your pharmacist for more||
1558|076|P|details.||
1558|077|P|   Before using this medication, tell your doctor or pharmacist||
1558|078|P|your medical history, especially of: glaucoma (angle-closure||
1558|079|P|type), blood vessel disorders (such as aneurysm).||
1558|080|P|   After you apply this drug, your vision may become temporarily||
1558|081|P|blurred. Do not drive, use machinery, or do anything that needs||
1558|082|P|clear vision until you can do it safely.||
1558|083|P|   During pregnancy, this medication should be used only when||
1558|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
1558|085|P|   It is unknown if this drug passes into breast milk. Consult||
1558|086|P|your doctor before breastfeeding.||
1558|087|B|||
1558|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1558|089|I|medications work or increase your risk for serious side effects.||
1558|090|I|This document does not contain all possible drug interactions.||
1558|091|I|Keep a list of all the products you use (including||
1558|092|I|prescription/nonprescription drugs and herbal products) and share||
1558|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
1558|094|I|the dosage of any medicines without your doctor's approval.||
1558|095|B|||
1558|096|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1558|097|O|has overdosed and has serious symptoms such as passing out or||
1558|098|O|trouble breathing, call 911. Otherwise, call a poison control||
1558|099|O|center right away. US residents can call 1-800-222-1222. Canada||
1558|100|O|residents can call 1-844-764-7669.||
1558|101|B|||
1558|102|N|NOTES:  Do not share this medication with others.||
1558|103|B|||
1558|104|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1558|105|D|If it is near the time of the next dose, skip the missed dose.||
1558|106|D|Use your next dose at the regular time. Do not double the dose to||
1558|107|D|catch up.||
1558|108|B|||
1558|109|R|STORAGE:  Different brands of this medication have different||
1558|110|R|storage needs. Check the product package for instructions on how||
1558|111|R|to store your brand, or ask your pharmacist. Keep all medications||
1558|112|R|away from children and pets.||
1558|113|R|   Do not flush medications down the toilet or pour them into a||
1558|114|R|drain unless instructed to do so. Properly discard this product||
1558|115|R|when it is expired or no longer needed. Consult your pharmacist||
1558|116|R|or local waste disposal company.||
1558|117|B|||
1558|118|A|Information last revised September 2024.||
1558|119|A|Copyright(c) 2025 First Databank, Inc.||
1558|120|B|||
1559|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1559|002|Z|does NOT have all possible information about this product. This||
1559|003|Z|information does not assure that this product is safe, effective,||
1559|004|Z|or appropriate for you. This information is not individual||
1559|005|Z|medical advice and does not substitute for the advice of your||
1559|006|Z|health care professional. Always ask your health care||
1559|007|Z|professional for complete information about this product and your||
1559|008|Z|specific health needs.||
1559|009|B|||
1559|010|T|PERAMPANEL - ORAL||
1559|011|F|(per-AM-pa-nel)||
1559|012|B|||
1559|013|C|COMMON BRAND NAME(S): Fycompa||
1559|014|B|||
1559|015|W|WARNING:  Perampanel may cause or worsen mental/mood disorders.||
1559|016|W|Tell your doctor right away if you or your family/caregiver||
1559|017|W|notice any unusual behavior changes (including aggression,||
1559|018|W|attempts to hurt others, impulsive actions) or other mental/mood||
1559|019|W|changes (including anxiety, irritability, hostile/angry feelings,||
1559|020|W|paranoia, hallucinations, delusions, thoughts of harming others).||
1559|021|W|Be especially watchful for these symptoms when you first start||
1559|022|W|this medication or when the dose is changed. These symptoms may||
1559|023|W|also occur even after stopping perampanel. Do not drink alcoholic||
1559|024|W|beverages while taking perampanel because alcohol may make these||
1559|025|W|symptoms worse.||
1559|026|B|||
1559|027|U|USES:  Perampanel is used to treat certain types of seizures||
1559|028|U|(including focal and generalized tonic-clonic seizures).||
1559|029|U|Perampanel belongs to a class of drugs known as anticonvulsants.||
1559|030|B|||
1559|031|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1559|032|H|Patient Information Leaflet provided by your pharmacist before||
1559|033|H|you start taking perampanel and each time you get a refill. If||
1559|034|H|you have any questions, ask your doctor or pharmacist.||
1559|035|H|   Take this medication by mouth as directed by your doctor,||
1559|036|H|usually once daily at bedtime.||
1559|037|H|   If you are using the liquid form of this medication, shake the||
1559|038|H|bottle well before each dose. Carefully measure the dose using a||
1559|039|H|special measuring device/spoon. Do not use a household spoon||
1559|040|H|because you may not get the correct dose.||
1559|041|H|   The dosage is based on your medical condition, response to||
1559|042|H|treatment, and other medications you may be taking. Be sure to||
1559|043|H|tell your doctor and pharmacist about all the products you use||
1559|044|H|(including prescription drugs, nonprescription drugs, and herbal||
1559|045|H|products).||
1559|046|H|   To reduce your risk of side effects, your doctor may direct||
1559|047|H|you to start this medication at a low dose and gradually increase||
1559|048|H|your dose. Follow your doctor's instructions carefully.||
1559|049|H|   Use this medication regularly to get the most benefit from it.||
1559|050|H|To help you remember, take it at the same time each day.||
1559|051|H|   Do not stop taking this medication without consulting your||
1559|052|H|doctor. Some conditions may become worse when this drug is||
1559|053|H|suddenly stopped. Your dose may need to be gradually decreased.||
1559|054|H|   Though it helps many people, this medication may sometimes||
1559|055|H|cause addiction. This risk may be higher if you have a substance||
1559|056|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1559|057|H|Take this medication exactly as prescribed to lower the risk of||
1559|058|H|addiction. Ask your doctor or pharmacist for more details.||
1559|059|H|   Tell your doctor if your condition does not get better or if||
1559|060|H|it gets worse.||
1559|061|B|||
1559|062|S|SIDE EFFECTS:  See also Warning Section.||
1559|063|S|   Dizziness, a feeling of spinning, unsteadiness, trouble||
1559|064|S|walking, loss of balance, drowsiness, weakness, nausea, vomiting,||
1559|065|S|headache, or weight gain may occur. If any of these effects last||
1559|066|S|or get worse, tell your doctor or pharmacist promptly.||
1559|067|S|   Remember that this medication has been prescribed because your||
1559|068|S|doctor has judged that the benefit to you is greater than the||
1559|069|S|risk of side effects. Many people using this medication do not||
1559|070|S|have serious side effects.||
1559|071|S|   Tell your doctor right away if you have any serious side||
1559|072|S|effects, including: blurred/double vision, frequent falls.||
1559|073|S|   A small number of people who take anticonvulsants for any||
1559|074|S|condition (such as seizures, bipolar disorder, pain) may||
1559|075|S|experience depression, suicidal thoughts/attempts, or other||
1559|076|S|mental/mood problems. Tell your doctor right away if you or your||
1559|077|S|family/caregiver notice any unusual/sudden changes in your mood,||
1559|078|S|thoughts, or behavior including signs of depression, suicidal||
1559|079|S|thoughts/attempts, thoughts about harming yourself.||
1559|080|S|   A very serious allergic reaction to this drug is rare.||
1559|081|S|However, get medical help right away if you notice any symptoms||
1559|082|S|of a serious allergic reaction, including: fever, swollen lymph||
1559|083|S|nodes, rash, itching/swelling (especially of the||
1559|084|S|face/tongue/throat), severe dizziness, trouble breathing.||
1559|085|S|   This is not a complete list of possible side effects. If you||
1559|086|S|notice other effects not listed above, contact your doctor or||
1559|087|S|pharmacist.||
1559|088|S|   In the US -||
1559|089|S|   Call your doctor for medical advice about side effects. You||
1559|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1559|091|S|www.fda.gov/medwatch.||
1559|092|S|   In Canada - Call your doctor for medical advice about side||
1559|093|S|effects. You may report side effects to Health Canada at||
1559|094|S|1-866-234-2345.||
1559|095|B|||
1559|096|P|PRECAUTIONS:  Before taking perampanel, tell your doctor or||
1559|097|P|pharmacist if you are allergic to it; or if you have any other||
1559|098|P|allergies. This product may contain inactive ingredients, which||
1559|099|P|can cause allergic reactions or other problems. Talk to your||
1559|100|P|pharmacist for more details.||
1559|101|P|   Before using this medication, tell your doctor or pharmacist||
1559|102|P|your medical history, especially of: liver problems, kidney||
1559|103|P|problems, mental/mood disorders, personal or family history of a||
1559|104|P|substance use disorder (such as overuse of or addiction to||
1559|105|P|drugs/alcohol), galactose intolerance (such as Lapp lactase||
1559|106|P|deficiency or glucose-galactose malabsorption).||
1559|107|P|   This drug may make you dizzy or drowsy or blur your vision.||
1559|108|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1559|109|P|drowsy. Do not drive, use machinery, or do anything that needs||
1559|110|P|alertness or clear vision until you can do it safely. Avoid||
1559|111|P|alcoholic beverages. Talk to your doctor if you are using||
1559|112|P|marijuana (cannabis).||
1559|113|P|   Before having surgery, tell your doctor or dentist about all||
1559|114|P|the products you use (including prescription drugs,||
1559|115|P|nonprescription drugs, and herbal products).||
1559|116|P|   Older adults may be more sensitive to the side effects of this||
1559|117|P|drug, especially falls, drowsiness, and weakness.||
1559|118|P|   During pregnancy, this medication should be used only when||
1559|119|P|clearly needed. It may harm an unborn baby. However, since||
1559|120|P|untreated seizures are a serious condition that can harm both a||
1559|121|P|pregnant woman and her unborn baby, do not stop taking this||
1559|122|P|medication unless directed by your doctor. If you are planning||
1559|123|P|pregnancy, become pregnant, or think you may be pregnant,||
1559|124|P|immediately discuss with your doctor the benefits and risks of||
1559|125|P|using this medication during pregnancy.||
1559|126|P|   It is unknown if this medication passes into breast milk.||
1559|127|P|Consult your doctor before breastfeeding.||
1559|128|B|||
1559|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1559|130|I|medications work or increase your risk for serious side effects.||
1559|131|I|This document does not contain all possible drug interactions.||
1559|132|I|Keep a list of all the products you use (including||
1559|133|I|prescription/nonprescription drugs and herbal products) and share||
1559|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
1559|135|I|the dosage of any medicines without your doctor's approval.||
1559|136|I|   A product that may interact with this drug is: orlistat.||
1559|137|I|   Other medications can affect the removal of perampanel from||
1559|138|I|your body, which may affect how perampanel works. Examples||
1559|139|I|include rifamycins (such as rifabutin), St. John's wort, among||
1559|140|I|others.||
1559|141|I|   This medication may decrease the effectiveness of||
1559|142|I|levonorgestrel-containing birth control. This could cause||
1559|143|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1559|144|I|use reliable non-hormonal backup birth control methods (such as||
1559|145|I|condoms, diaphragm with spermicide) while using perampanel and||
1559|146|I|for a month after you stop using perampanel. Also tell your||
1559|147|I|doctor if you have any new spotting or breakthrough bleeding,||
1559|148|I|because these may be signs that your birth control is not working||
1559|149|I|well.||
1559|150|I|   Tell your doctor or pharmacist if you are taking other||
1559|151|I|products that cause drowsiness including alcohol, marijuana||
1559|152|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1559|153|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1559|154|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1559|155|I|codeine).||
1559|156|I|   Check the labels on all your medicines (such as allergy or||
1559|157|I|cough-and-cold products) because they may contain ingredients||
1559|158|I|that cause drowsiness. Ask your pharmacist about using those||
1559|159|I|products safely.||
1559|160|B|||
1559|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1559|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1559|163|O|poison control center right away. US residents can call||
1559|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1559|165|O|Symptoms of overdose may include: mental/mood/behavior changes||
1559|166|O|such as agitation, aggressive behavior.||
1559|167|B|||
1559|168|N|NOTES:  Do not share this medication with others. Sharing it is||
1559|169|N|against the law.||
1559|170|N|   Lab and/or medical tests (such as weight) should be done while||
1559|171|N|you are taking this medication. Keep all medical and lab||
1559|172|N|appointments. Consult your doctor for more details.||
1559|173|B|||
1559|174|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1559|175|D|next dose at the regular time. Do not double the dose to catch||
1559|176|D|up. If you miss more than 1 dose, contact your doctor for more||
1559|177|D|information.||
1559|178|B|||
1559|179|R|STORAGE:  Store the tablets at room temperature away from light||
1559|180|R|and moisture. Do not store in the bathroom. Store the liquid form||
1559|181|R|at room temperature or in the refrigerator. Do not freeze. Once||
1559|182|R|the bottle for the liquid form is opened, the medication expires||
1559|183|R|after 90 days. Keep all medications away from children and pets.||
1559|184|R|   Do not flush medications down the toilet or pour them into a||
1559|185|R|drain unless instructed to do so. Properly discard this product||
1559|186|R|when it is expired or no longer needed. Consult your pharmacist||
1559|187|R|or local waste disposal company.||
1559|188|B|||
1559|189|M|MEDICAL ALERT:  Your condition can cause complications in a||
1559|190|M|medical emergency. For information about enrolling in MedicAlert,||
1559|191|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1559|192|B|||
1559|193|A|Information last revised February 2025.||
1559|194|A|Copyright(c) 2025 First Databank, Inc.||
1559|195|B|||
1560|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1560|002|Z|does NOT have all possible information about this product. This||
1560|003|Z|information does not assure that this product is safe, effective,||
1560|004|Z|or appropriate for you. This information is not individual||
1560|005|Z|medical advice and does not substitute for the advice of your||
1560|006|Z|health care professional. Always ask your health care||
1560|007|Z|professional for complete information about this product and your||
1560|008|Z|specific health needs.||
1560|009|B|||
1560|010|T|ENALAPRIL SOLUTION - ORAL||
1560|011|F|(en-AL-a-pril)||
1560|012|B|||
1560|013|C|COMMON BRAND NAME(S): Epaned||
1560|014|B|||
1560|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
1560|016|W|unborn baby if used during pregnancy. It is important to prevent||
1560|017|W|pregnancy while taking this medication. Consult your doctor for||
1560|018|W|more details and to discuss the use of reliable forms of birth||
1560|019|W|control while taking this medication. If you are planning||
1560|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
1560|021|W|your doctor right away.||
1560|022|B|||
1560|023|U|USES:  Enalapril is used to treat high blood pressure. Lowering||
1560|024|U|high blood pressure helps prevent strokes, heart attacks, and||
1560|025|U|kidney problems. It is also used to treat heart failure and to||
1560|026|U|help prevent people with a certain heart problem (left||
1560|027|U|ventricular dysfunction) from developing heart failure.||
1560|028|U|   Enalapril belongs to a class of drugs known as ACE inhibitors.||
1560|029|U|It works by relaxing blood vessels so blood can flow more easily.||
1560|030|B|||
1560|031|V|OTHER USES:  This section contains uses of this drug that are not||
1560|032|V|listed in the approved professional labeling for the drug but||
1560|033|V|that may be prescribed by your health care professional. Use this||
1560|034|V|drug for a condition that is listed in this section only if it||
1560|035|V|has been so prescribed by your health care professional.||
1560|036|V|   This medication may also be used for kidney disease and to||
1560|037|V|help protect the kidneys from harm due to diabetes.||
1560|038|B|||
1560|039|H|HOW TO USE:  Take this medication by mouth with or without food||
1560|040|H|as directed by your doctor, usually once or twice daily.||
1560|041|H|   Carefully measure the dose using a special measuring||
1560|042|H|device/spoon. Do not use a household spoon because you may not||
1560|043|H|get the correct dose.||
1560|044|H|   The dosage is based on your medical condition and response to||
1560|045|H|treatment. Children's dosage is also based on weight.||
1560|046|H|   Use this medication regularly to get the most benefit from it.||
1560|047|H|To help you remember, take it at the same time(s) each day. Keep||
1560|048|H|taking this medication even if you feel well. Most people with||
1560|049|H|high blood pressure do not feel sick.||
1560|050|H|   For the treatment of high blood pressure, it may take several||
1560|051|H|weeks before you get the full benefit of this medication. For the||
1560|052|H|treatment of heart failure, it may take weeks to months before||
1560|053|H|you get the full benefit of this medication.||
1560|054|H|   Tell your doctor if your condition does not get better or if||
1560|055|H|it gets worse (for example, your blood pressure readings remain||
1560|056|H|high or increase).||
1560|057|B|||
1560|058|S|SIDE EFFECTS:  Dizziness, lightheadedness, or weakness may occur||
1560|059|S|as your body adjusts to the medication. Dry cough may also occur.||
1560|060|S|If any of these effects last or get worse, tell your doctor or||
1560|061|S|pharmacist promptly.||
1560|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
1560|063|S|slowly when rising from a sitting or lying position.||
1560|064|S|   Remember that this medication has been prescribed because your||
1560|065|S|doctor has judged that the benefit to you is greater than the||
1560|066|S|risk of side effects. Many people using this medication do not||
1560|067|S|have serious side effects.||
1560|068|S|   Tell your doctor right away if you have any serious side||
1560|069|S|effects, including: fainting, symptoms of a high potassium blood||
1560|070|S|level (such as muscle weakness, slow/irregular heartbeat).||
1560|071|S|   Although enalapril may be used to prevent kidney problems or||
1560|072|S|treat people who have kidney problems, it may also rarely cause||
1560|073|S|serious kidney problems or make them worse. Your doctor will||
1560|074|S|check your kidney function while you are taking enalapril. Tell||
1560|075|S|your doctor right away if you have any signs of kidney problems||
1560|076|S|such as a change in the amount of urine.||
1560|077|S|   This drug may rarely cause serious (possibly fatal) liver||
1560|078|S|problems. Get medical help right away if you have any symptoms of||
1560|079|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1560|080|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1560|081|S|urine.||
1560|082|S|   A very serious allergic reaction to this drug is rare.||
1560|083|S|However, get medical help right away if you notice any symptoms||
1560|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1560|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1560|086|S|breathing.||
1560|087|S|   This is not a complete list of possible side effects. If you||
1560|088|S|notice other effects not listed above, contact your doctor or||
1560|089|S|pharmacist.||
1560|090|S|   In the US -||
1560|091|S|   Call your doctor for medical advice about side effects. You||
1560|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1560|093|S|www.fda.gov/medwatch.||
1560|094|S|   In Canada - Call your doctor for medical advice about side||
1560|095|S|effects. You may report side effects to Health Canada at||
1560|096|S|1-866-234-2345.||
1560|097|B|||
1560|098|P|PRECAUTIONS:  Before taking enalapril, tell your doctor or||
1560|099|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
1560|100|P|(such as benazepril); or if you have any other allergies. This||
1560|101|P|product may contain inactive ingredients, which can cause||
1560|102|P|allergic reactions or other problems. Talk to your pharmacist for||
1560|103|P|more details.||
1560|104|P|   Before using this medication, tell your doctor or pharmacist||
1560|105|P|your medical history, especially of: history of an allergic||
1560|106|P|reaction which included swelling of the face/lips/tongue/throat||
1560|107|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
1560|108|P|dialysis), high level of potassium in the blood.||
1560|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1560|110|P|can make you more dizzy. Do not drive, use machinery, or do||
1560|111|P|anything that needs alertness until you can do it safely. Limit||
1560|112|P|alcoholic beverages. Talk to your doctor if you are using||
1560|113|P|marijuana (cannabis).||
1560|114|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1560|115|P|and cause you to feel lightheaded. Tell your doctor if you have||
1560|116|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1560|117|P|of fluids unless your doctor tells you not to.||
1560|118|P|   Before having surgery, tell your doctor or dentist about all||
1560|119|P|the products you use (including prescription drugs,||
1560|120|P|nonprescription drugs, and herbal products).||
1560|121|P|   This medication may increase your potassium levels. Before||
1560|122|P|using potassium supplements or salt substitutes that contain||
1560|123|P|potassium, consult your doctor or pharmacist.||
1560|124|P|   Older adults may be more sensitive to the side effects of this||
1560|125|P|drug, including dizziness and increases in potassium level.||
1560|126|P|   Tell your doctor if you are pregnant or plan to become||
1560|127|P|pregnant. You should not become pregnant while using enalapril.||
1560|128|P|Enalapril may harm an unborn baby. If you become pregnant, talk||
1560|129|P|to your doctor right away about the risks and benefits of this||
1560|130|P|medication. (See also Warning section.)||
1560|131|P|   This medication passes into breast milk but is unlikely to||
1560|132|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1560|133|B|||
1560|134|I|DRUG INTERACTIONS:  See also Precautions section.||
1560|135|I|   Drug interactions may change how your medications work or||
1560|136|I|increase your risk for serious side effects. This document does||
1560|137|I|not contain all possible drug interactions. Keep a list of all||
1560|138|I|the products you use (including prescription/nonprescription||
1560|139|I|drugs and herbal products) and share it with your doctor and||
1560|140|I|pharmacist. Do not start, stop, or change the dosage of any||
1560|141|I|medicines without your doctor's approval.||
1560|142|I|   Some products that may interact with this drug include:||
1560|143|I|aliskiren, certain drugs that weaken the immune system/increase||
1560|144|I|the risk of infection (such as everolimus, sirolimus), lithium,||
1560|145|I|drugs that may increase the level of potassium in the blood (such||
1560|146|I|as ARBs including losartan/valsartan, birth control pills||
1560|147|I|containing drospirenone), sacubitril.||
1560|148|I|   Some products have ingredients that could raise your blood||
1560|149|I|pressure or worsen your heart failure. Tell your pharmacist what||
1560|150|I|products you are using, and ask how to use them safely||
1560|151|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
1560|152|I|ibuprofen/naproxen).||
1560|153|I|   A very serious reaction may occur if you are getting||
1560|154|I|injections for bee/wasp sting allergy (desensitization) and are||
1560|155|I|also taking enalapril. Make sure all your doctors know you use||
1560|156|I|this drug.||
1560|157|B|||
1560|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1560|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1560|160|O|poison control center right away. US residents can call||
1560|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1560|162|O|Symptoms of overdose may include: severe dizziness, fainting.||
1560|163|B|||
1560|164|N|NOTES:  Do not share this medication with others.||
1560|165|N|   Lifestyle changes that may help this medication work better||
1560|166|N|include exercising, stopping smoking, and eating a||
1560|167|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1560|168|N|details.||
1560|169|N|   Lab and/or medical tests (such as kidney function, potassium||
1560|170|N|levels) should be done while you are taking this medication. Keep||
1560|171|N|all medical and lab appointments. Consult your doctor for more||
1560|172|N|details.||
1560|173|N|   Have your blood pressure checked regularly while taking this||
1560|174|N|medication. Learn how to monitor your own blood pressure at home,||
1560|175|N|and share the results with your doctor.||
1560|176|B|||
1560|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1560|178|D|remember. If it is near the time of the next dose, skip the||
1560|179|D|missed dose. Take your next dose at the regular time. Do not||
1560|180|D|double the dose to catch up.||
1560|181|B|||
1560|182|R|STORAGE:  Different brands of this medication have different||
1560|183|R|storage needs. Check the product package for instructions on how||
1560|184|R|to store your brand, or ask your pharmacist. Keep all medications||
1560|185|R|away from children and pets.||
1560|186|R|   Do not flush medications down the toilet or pour them into a||
1560|187|R|drain unless instructed to do so. Properly discard this product||
1560|188|R|when it is expired or no longer needed. Consult your pharmacist||
1560|189|R|or local waste disposal company.||
1560|190|B|||
1560|191|A|Information last revised August 2024.||
1560|192|A|Copyright(c) 2025 First Databank, Inc.||
1560|193|B|||
1561|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1561|002|Z|does NOT have all possible information about this product. This||
1561|003|Z|information does not assure that this product is safe, effective,||
1561|004|Z|or appropriate for you. This information is not individual||
1561|005|Z|medical advice and does not substitute for the advice of your||
1561|006|Z|health care professional. Always ask your health care||
1561|007|Z|professional for complete information about this product and your||
1561|008|Z|specific health needs.||
1561|009|B|||
1561|010|T|DOLUTEGRAVIR - ORAL||
1561|011|F|(DOE-loo-TEG-ra-vir)||
1561|012|B|||
1561|013|C|COMMON BRAND NAME(S): Tivicay||
1561|014|B|||
1561|015|U|USES:  Dolutegravir is used with other HIV medications to help||
1561|016|U|control HIV infection. It helps to decrease the amount of HIV in||
1561|017|U|your body so your immune system can work better. This lowers your||
1561|018|U|chance of getting HIV complications (such as new infections,||
1561|019|U|cancer) and improves your quality of life. Dolutegravir belongs||
1561|020|U|to a class of drugs known as integrase inhibitors. It blocks the||
1561|021|U|virus from growing and infecting more cells.||
1561|022|U|   Dolutegravir is not a cure for HIV infection. To decrease your||
1561|023|U|risk of spreading HIV disease to others, continue to take all HIV||
1561|024|U|medications exactly as prescribed by your doctor. Use an||
1561|025|U|effective barrier method (latex or polyurethane condoms/dental||
1561|026|U|dams) during sexual activity as directed by your doctor. Do not||
1561|027|U|share personal items (such as needles/syringes, toothbrushes, and||
1561|028|U|razors) that may have contacted blood or other body fluids.||
1561|029|U|Consult your doctor or pharmacist for more details.||
1561|030|B|||
1561|031|V|OTHER USES:  This section contains uses of this drug that are not||
1561|032|V|listed in the approved professional labeling for the drug but||
1561|033|V|that may be prescribed by your health care professional. Use this||
1561|034|V|drug for a condition that is listed in this section only if it||
1561|035|V|has been so prescribed by your health care professional.||
1561|036|V|   This product may also be used to reduce the risk of getting||
1561|037|V|HIV infection after contact with the virus (for example, due to a||
1561|038|V|needle stick). Consult your doctor for more details.||
1561|039|B|||
1561|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1561|041|H|from your pharmacist before you start taking dolutegravir and||
1561|042|H|each time you get a refill. If you have any questions, ask your||
1561|043|H|doctor or pharmacist.||
1561|044|H|   Do not change dosage forms of this medication without checking||
1561|045|H|with your doctor or pharmacist.||
1561|046|H|   Take this medication by mouth with or without food as directed||
1561|047|H|by your doctor, usually 1 to 2 times daily.||
1561|048|H|   Take this medication at least 2 hours before or 6 hours after||
1561|049|H|taking sucralfate and products containing aluminum or magnesium||
1561|050|H|(such as antacids, laxatives, buffered medications). These||
1561|051|H|products bind with dolutegravir, decreasing its effectiveness.||
1561|052|H|   If you are also taking calcium or iron supplements (including||
1561|053|H|vitamins/minerals that contain calcium or iron), take||
1561|054|H|dolutegravir at least 2 hours before or 6 hours after these||
1561|055|H|products. Or, if you take dolutegravir with food, you can take||
1561|056|H|calcium or iron supplements at the same time.||
1561|057|H|   The dosage is based on your medical condition, response to||
1561|058|H|treatment, age, and other medications you may be taking.||
1561|059|H|Children's dosage is also based on weight. Be sure to tell your||
1561|060|H|doctor and pharmacist about all the products you use (including||
1561|061|H|prescription drugs, nonprescription drugs, and herbal products).||
1561|062|H|   It is very important to keep taking this medication (and other||
1561|063|H|HIV medications) exactly as prescribed by your doctor. Do not||
1561|064|H|skip any doses.||
1561|065|H|   For the best effect, take this medication at evenly spaced||
1561|066|H|times. To help you remember, take this medication at the same||
1561|067|H|time(s) every day.||
1561|068|H|   Do not take more or less of this drug than prescribed or stop||
1561|069|H|taking it (or other HIV medicines) even for a short time unless||
1561|070|H|directed to do so by your doctor. Doing so may cause the amount||
1561|071|H|of virus to increase, make the infection more difficult to treat||
1561|072|H|(resistant), or worsen side effects.||
1561|073|B|||
1561|074|S|SIDE EFFECTS:  Headache and trouble sleeping may occur. If either||
1561|075|S|of these effects lasts or gets worse, tell your doctor or||
1561|076|S|pharmacist promptly.||
1561|077|S|   Remember that this medication has been prescribed because your||
1561|078|S|doctor has judged that the benefit to you is greater than the||
1561|079|S|risk of side effects. Many people using this medication do not||
1561|080|S|have serious side effects.||
1561|081|S|   Tell your doctor right away if you have any serious side||
1561|082|S|effects, including: symptoms of liver problems (such as||
1561|083|S|nausea/vomiting that doesn't stop, loss of appetite,||
1561|084|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
1561|085|S|of kidney problems (such as change in the amount of urine),||
1561|086|S|mental/mood changes (such as depression, thoughts of suicide).||
1561|087|S|   As your immune system gets stronger, it can begin to fight off||
1561|088|S|infections you already had, possibly causing disease symptoms to||
1561|089|S|come back. You could also have symptoms if your immune system||
1561|090|S|becomes overactive. This reaction may happen at any time (soon||
1561|091|S|after starting HIV treatment or many months later). Tell your||
1561|092|S|doctor right away if you have any serious symptoms, including:||
1561|093|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1561|094|S|that doesn't go away, headaches that are severe or don't go away,||
1561|095|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1561|096|S|changes, signs of infection (such as sore throat that doesn't go||
1561|097|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1561|098|S|sores), signs of an overactive thyroid (such as irritability,||
1561|099|S|nervousness, heat intolerance, fast/pounding/irregular||
1561|100|S|heartbeat).||
1561|101|S|   A very serious allergic reaction to this drug is rare.||
1561|102|S|However, get medical help right away if you notice any symptoms||
1561|103|S|of a serious allergic reaction, including: rash, itching/swelling||
1561|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1561|105|S|breathing.||
1561|106|S|   This is not a complete list of possible side effects. If you||
1561|107|S|notice other effects not listed above, contact your doctor or||
1561|108|S|pharmacist.||
1561|109|S|   In the US -||
1561|110|S|   Call your doctor for medical advice about side effects. You||
1561|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1561|112|S|www.fda.gov/medwatch.||
1561|113|S|   In Canada - Call your doctor for medical advice about side||
1561|114|S|effects. You may report side effects to Health Canada at||
1561|115|S|1-866-234-2345.||
1561|116|B|||
1561|117|P|PRECAUTIONS:  Before taking dolutegravir, tell your doctor or||
1561|118|P|pharmacist if you are allergic to it; or if you have any other||
1561|119|P|allergies. This product may contain inactive ingredients, which||
1561|120|P|can cause allergic reactions or other problems. Talk to your||
1561|121|P|pharmacist for more details.||
1561|122|P|   Before using this medication, tell your doctor or pharmacist||
1561|123|P|your medical history, especially of: liver disease (such as||
1561|124|P|hepatitis B, hepatitis C), kidney disease.||
1561|125|P|   Before having surgery, tell your doctor or dentist about all||
1561|126|P|the products you use (including prescription drugs,||
1561|127|P|nonprescription drugs, and herbal products).||
1561|128|P|   Tell your doctor if you are pregnant before using this||
1561|129|P|medication. Treatment can lower the risk of passing HIV infection||
1561|130|P|to your baby. Discuss the risks and benefits with your doctor.||
1561|131|P|   This medication passes into breast milk. Because breast milk||
1561|132|P|may transmit HIV, consult your doctor before breastfeeding.||
1561|133|B|||
1561|134|I|DRUG INTERACTIONS:  See also How to Use section.||
1561|135|I|   Drug interactions may change how your medications work or||
1561|136|I|increase your risk for serious side effects. This document does||
1561|137|I|not contain all possible drug interactions. Keep a list of all||
1561|138|I|the products you use (including prescription/nonprescription||
1561|139|I|drugs and herbal products) and share it with your doctor and||
1561|140|I|pharmacist. Do not start, stop, or change the dosage of any||
1561|141|I|medicines without your doctor's approval.||
1561|142|I|   Some products that may interact with this drug are:||
1561|143|I|dofetilide, orlistat.||
1561|144|B|||
1561|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1561|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1561|147|O|poison control center right away. US residents can call||
1561|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1561|149|B|||
1561|150|N|NOTES:  Do not share this medication with others.||
1561|151|N|   Lab and/or medical tests (such as liver/kidney function, viral||
1561|152|N|load, T-cell counts) should be done while you are taking this||
1561|153|N|medication. Keep all medical and lab appointments. Consult your||
1561|154|N|doctor for more details.||
1561|155|B|||
1561|156|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1561|157|D|remember. If it is near the time of the next dose, skip the||
1561|158|D|missed dose. Take your next dose at the regular time. Do not||
1561|159|D|double the dose to catch up.||
1561|160|B|||
1561|161|R|STORAGE:  Store at room temperature away from light and moisture.||
1561|162|R|Do not store in the bathroom. For the 10-milligram tablets, store||
1561|163|R|in the original container. Keep the drying agent (desiccant) in||
1561|164|R|the bottle. Tightly close the bottle when not in use. Keep all||
1561|165|R|medications away from children and pets.||
1561|166|R|   Do not flush medications down the toilet or pour them into a||
1561|167|R|drain unless instructed to do so. Properly discard this product||
1561|168|R|when it is expired or no longer needed. Consult your pharmacist||
1561|169|R|or local waste disposal company.||
1561|170|B|||
1561|171|A|Information last revised April 2025.||
1561|172|A|Copyright(c) 2025 First Databank, Inc.||
1561|173|B|||
1562|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1562|002|Z|does NOT have all possible information about this product. This||
1562|003|Z|information does not assure that this product is safe, effective,||
1562|004|Z|or appropriate for you. This information is not individual||
1562|005|Z|medical advice and does not substitute for the advice of your||
1562|006|Z|health care professional. Always ask your health care||
1562|007|Z|professional for complete information about this product and your||
1562|008|Z|specific health needs.||
1562|009|B|||
1562|010|T|AFATINIB - ORAL||
1562|011|F|(a-FA-ti-nib)||
1562|012|B|||
1562|013|C|COMMON BRAND NAME(S): Gilotrif||
1562|014|B|||
1562|015|U|USES:  Afatinib is used to treat a certain type of lung cancer||
1562|016|U|(non-small cell lung cancer). It belongs to a class of drugs||
1562|017|U|known as kinase inhibitors. It works by slowing or stopping the||
1562|018|U|growth of cancer cells. It binds to a certain protein (epidermal||
1562|019|U|growth factor receptor-EGFR) in some tumors.||
1562|020|B|||
1562|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1562|022|H|from your pharmacist before you start taking afatinib and each||
1562|023|H|time you get a refill. If you have any questions, ask your doctor||
1562|024|H|or pharmacist.||
1562|025|H|   Take this medication by mouth as directed by your doctor,||
1562|026|H|usually once daily at least 1 hour before or 2 hours after a||
1562|027|H|meal.||
1562|028|H|   The dosage is based on your medical condition, response to||
1562|029|H|treatment, and other medications you may be taking. Be sure to||
1562|030|H|tell your doctor and pharmacist about all the products you use||
1562|031|H|(including prescription drugs, nonprescription drugs, and herbal||
1562|032|H|products).||
1562|033|H|   Use this medication regularly to get the most benefit from it.||
1562|034|H|To help you remember, take it at the same time each day.||
1562|035|H|   Do not increase your dose or use this drug more often or for||
1562|036|H|longer than prescribed. Your condition will not improve any||
1562|037|H|faster, and your risk of serious side effects will increase.||
1562|038|H|   Since this drug can be absorbed through the skin and lungs and||
1562|039|H|may harm an unborn baby, women who are pregnant or who may become||
1562|040|H|pregnant should not handle this medication or breathe the dust||
1562|041|H|from the tablets.||
1562|042|B|||
1562|043|S|SIDE EFFECTS:  Mouth sores, pain/redness/swelling of lips,||
1562|044|S|dry/itchy skin, acne, nose bleed, runny nose, nausea/vomiting, or||
1562|045|S|loss of appetite may occur. If any of these effects last or get||
1562|046|S|worse, tell your doctor or pharmacist promptly.||
1562|047|S|   Remember that this medication has been prescribed because your||
1562|048|S|doctor has judged that the benefit to you is greater than the||
1562|049|S|risk of side effects. Many people using this medication do not||
1562|050|S|have serious side effects.||
1562|051|S|   Diarrhea is a common side effect. Drink plenty of fluids as||
1562|052|S|directed by your doctor to reduce your risk of dehydration. Your||
1562|053|S|doctor may prescribe anti-diarrhea medication (such as||
1562|054|S|loperamide) to control your symptoms. Tell your doctor right away||
1562|055|S|if you develop: diarrhea that is severe or doesn't stop, symptoms||
1562|056|S|of dehydration (such as unusual decreased urination, unusual dry||
1562|057|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness).||
1562|058|S|   Tell your doctor right away if you have any serious side||
1562|059|S|effects, including: signs of eye disease (such as vision changes,||
1562|060|S|eye redness/pain, light sensitivity, eye discharge), signs of low||
1562|061|S|level of potassium in the blood (such as muscle cramps, weakness,||
1562|062|S|irregular heartbeat), signs of bladder infection (such as||
1562|063|S|burning/pain when you urinate, urgent or frequent urination,||
1562|064|S|fever), signs of skin infection around nails/toenails (such as||
1562|065|S|skin irritation/redness around the nail, change in nail color).||
1562|066|S|   Get medical help right away if you have any very serious side||
1562|067|S|effects, including: symptoms of lung problems (such as trouble||
1562|068|S|breathing, chest pain), symptoms of heart failure (such as||
1562|069|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
1562|070|S|unusual/sudden weight gain).||
1562|071|S|   Afatinib may rarely cause serious (possibly fatal) liver||
1562|072|S|disease or tear in the stomach or intestinal wall (perforation).||
1562|073|S|Get medical help right away if you have symptoms such as:||
1562|074|S|nausea/vomiting that doesn't stop, loss of appetite, dark urine,||
1562|075|S|stomach/abdominal pain, yellowing eyes/skin.||
1562|076|S|   Afatinib can commonly cause a rash that is usually not||
1562|077|S|serious. However, you may not be able to tell it apart from a||
1562|078|S|rare rash that could be a sign of a severe reaction. Get medical||
1562|079|S|help right away if you develop any rash.||
1562|080|S|   A very serious allergic reaction to this drug is rare.||
1562|081|S|However, get medical help right away if you notice any symptoms||
1562|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1562|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1562|084|S|breathing.||
1562|085|S|   This is not a complete list of possible side effects. If you||
1562|086|S|notice other effects not listed above, contact your doctor or||
1562|087|S|pharmacist.||
1562|088|S|   In the US -||
1562|089|S|   Call your doctor for medical advice about side effects. You||
1562|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1562|091|S|www.fda.gov/medwatch.||
1562|092|S|   In Canada - Call your doctor for medical advice about side||
1562|093|S|effects. You may report side effects to Health Canada at||
1562|094|S|1-866-234-2345.||
1562|095|B|||
1562|096|P|PRECAUTIONS:  Before taking afatinib, tell your doctor or||
1562|097|P|pharmacist if you are allergic to it; or if you have any other||
1562|098|P|allergies. This product may contain inactive ingredients, which||
1562|099|P|can cause allergic reactions or other problems. Talk to your||
1562|100|P|pharmacist for more details.||
1562|101|P|   Before using this medication, tell your doctor or pharmacist||
1562|102|P|your medical history, especially of: kidney problems, liver||
1562|103|P|problems, stomach/intestinal problems (such as ulcers,||
1562|104|P|diverticular disease), eye disease (such as severe dry eyes,||
1562|105|P|keratitis), use of contact lenses.||
1562|106|P|   This drug may cause blurred vision. Do not drive, use||
1562|107|P|machinery, or do anything that needs clear vision until you can||
1562|108|P|do it safely. Limit alcoholic beverages.||
1562|109|P|   This medication may make you more sensitive to the sun. Limit||
1562|110|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1562|111|P|sunscreen and wear protective clothing when outdoors. Tell your||
1562|112|P|doctor right away if you get sunburned or have skin||
1562|113|P|blisters/redness.||
1562|114|P|   Before having surgery, tell your doctor or dentist about all||
1562|115|P|the products you use (including prescription drugs,||
1562|116|P|nonprescription drugs, and herbal products).||
1562|117|P|   Tell your doctor if you are pregnant or plan to become||
1562|118|P|pregnant. You should not become pregnant while using afatinib.||
1562|119|P|Afatinib may harm an unborn baby. Ask about reliable forms of||
1562|120|P|birth control while using this medication and for at least 2||
1562|121|P|weeks after the last dose. If you become pregnant, talk to your||
1562|122|P|doctor right away about the risks and benefits of this||
1562|123|P|medication.||
1562|124|P|   Since this drug can be absorbed through the skin and lungs and||
1562|125|P|may harm an unborn baby, women who are pregnant or who may become||
1562|126|P|pregnant should not handle this medication or breathe the dust||
1562|127|P|from the tablets.||
1562|128|P|   It is unknown if this drug passes into breast milk. Because of||
1562|129|P|the possible risk to the infant, breastfeeding is not recommended||
1562|130|P|while using this drug and for 2 weeks after the last dose.||
1562|131|P|Consult your doctor before breastfeeding.||
1562|132|B|||
1562|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1562|134|I|medications work or increase your risk for serious side effects.||
1562|135|I|This document does not contain all possible drug interactions.||
1562|136|I|Keep a list of all the products you use (including||
1562|137|I|prescription/nonprescription drugs and herbal products) and share||
1562|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
1562|139|I|the dosage of any medicines without your doctor's approval.||
1562|140|B|||
1562|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1562|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1562|143|O|poison control center right away. US residents can call||
1562|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1562|145|O|Symptoms of overdose may include: severe nausea/vomiting/stomach||
1562|146|O|pain, severe dizziness, weakness.||
1562|147|B|||
1562|148|N|NOTES:  Do not share this medication with others.||
1562|149|N|   Lab and/or medical tests (such as liver function) should be||
1562|150|N|done while you are taking this medication. Keep all medical and||
1562|151|N|lab appointments. Consult your doctor for more details.||
1562|152|B|||
1562|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1562|154|D|remember. If it is more than 12 hours after the missed dose, skip||
1562|155|D|the missed dose. Take your next dose at the regular time. Do not||
1562|156|D|double the dose to catch up.||
1562|157|B|||
1562|158|R|STORAGE:  Store in the original container at room temperature||
1562|159|R|away from light and moisture. Do not store in the bathroom. Keep||
1562|160|R|all medications away from children and pets.||
1562|161|R|   Do not flush medications down the toilet or pour them into a||
1562|162|R|drain unless instructed to do so. Properly discard this product||
1562|163|R|when it is expired or no longer needed. Consult your pharmacist||
1562|164|R|or local waste disposal company.||
1562|165|B|||
1562|166|A|Information last revised April 2025.||
1562|167|A|Copyright(c) 2025 First Databank, Inc.||
1562|168|B|||
1563|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1563|002|Z|does NOT have all possible information about this product. This||
1563|003|Z|information does not assure that this product is safe, effective,||
1563|004|Z|or appropriate for you. This information is not individual||
1563|005|Z|medical advice and does not substitute for the advice of your||
1563|006|Z|health care professional. Always ask your health care||
1563|007|Z|professional for complete information about this product and your||
1563|008|Z|specific health needs.||
1563|009|B|||
1563|010|T|TOPIRAMATE EXTENDED-RELEASE - ORAL||
1563|011|F|(toe-PYRE-a-mate)||
1563|012|B|||
1563|013|C|COMMON BRAND NAME(S): Trokendi XR||
1563|014|B|||
1563|015|U|USES:  Topiramate is used alone or with other medications to||
1563|016|U|prevent and control seizures (epilepsy). It is also used to||
1563|017|U|prevent migraine headaches. Topiramate belongs to a class of||
1563|018|U|drugs known as anticonvulsants.||
1563|019|B|||
1563|020|V|OTHER USES:  This section contains uses of this drug that are not||
1563|021|V|listed in the approved professional labeling for the drug but||
1563|022|V|that may be prescribed by your health care professional. Use this||
1563|023|V|drug for a condition that is listed in this section only if it||
1563|024|V|has been so prescribed by your health care professional.||
1563|025|V|   This drug may also be used for binge eating disorder (BED).||
1563|026|B|||
1563|027|H|HOW TO USE:  Read the Medication Guide provided by your||
1563|028|H|pharmacist before you start taking topiramate and each time you||
1563|029|H|get a refill. If you have any questions, ask your doctor or||
1563|030|H|pharmacist.||
1563|031|H|   Take this medication by mouth with or without food as directed||
1563|032|H|by your doctor, usually once a day. Swallow the capsules whole.||
1563|033|H|Do not sprinkle on food, crush, dissolve, or chew. Doing so can||
1563|034|H|release all of the drug at once, increasing the risk of side||
1563|035|H|effects. Do not drink alcoholic beverages for 6 hours before or 6||
1563|036|H|hours after taking topiramate extended-release capsules, since||
1563|037|H|alcohol may affect how well this medication works.||
1563|038|H|   To prevent kidney stones from forming, drink plenty of fluids||
1563|039|H|while taking this medication unless otherwise directed by your||
1563|040|H|doctor.||
1563|041|H|   The dosage is based on your medical condition and response to||
1563|042|H|treatment. Children's dosage is also based on weight. To reduce||
1563|043|H|your risk of side effects, your doctor may direct you to start||
1563|044|H|this medication at a low dose and gradually increase your dose.||
1563|045|H|Carefully follow your doctor's instructions.||
1563|046|H|   Take this medication regularly to get the most benefit from||
1563|047|H|it. To help you remember, take it at the same time each day. Do||
1563|048|H|not stop taking this medication without consulting your doctor.||
1563|049|H|Some conditions may become worse when this drug is suddenly||
1563|050|H|stopped. Your dose may need to be gradually decreased.||
1563|051|H|   Tell your doctor if your condition does not get better or if||
1563|052|H|it gets worse.||
1563|053|B|||
1563|054|S|SIDE EFFECTS:  Tiredness, drowsiness, dizziness, loss of||
1563|055|S|coordination, nervousness, tingling of the hands/feet, loss of||
1563|056|S|appetite, changes in how foods taste, diarrhea, or weight loss||
1563|057|S|may occur. If any of these effects last or get worse, tell your||
1563|058|S|doctor or pharmacist promptly.||
1563|059|S|   Remember that this medication has been prescribed because your||
1563|060|S|doctor has judged that the benefit to you is greater than the||
1563|061|S|risk of side effects. Many people using this medication do not||
1563|062|S|have serious side effects.||
1563|063|S|   Tell your doctor right away if you have any serious side||
1563|064|S|effects, including: bone pain, signs of kidney stones (such as||
1563|065|S|severe back/side/abdominal/groin pain, fever, chills,||
1563|066|S|painful/frequent urination, bloody/pink urine), unusual||
1563|067|S|bleeding/bruising, confusion, difficulty concentrating, memory||
1563|068|S|loss, difficulty speaking.||
1563|069|S|   Get medical help right away if you have any very serious side||
1563|070|S|effects, including: rapid breathing, fast/slow/irregular||
1563|071|S|heartbeat.||
1563|072|S|   A small number of people who take anticonvulsants for any||
1563|073|S|condition (such as seizures, bipolar disorder, pain) may||
1563|074|S|experience depression, suicidal thoughts/attempts, or other||
1563|075|S|mental/mood problems. Tell your doctor right away if you or your||
1563|076|S|family/caregiver notice any unusual/sudden changes in your mood,||
1563|077|S|thoughts, or behavior including signs of depression, suicidal||
1563|078|S|thoughts/attempts, thoughts about harming yourself.||
1563|079|S|   Rarely, topiramate may cause a very serious eye problem,||
1563|080|S|usually within 1 month of starting treatment. This eye problem||
1563|081|S|can lead to permanent blindness. Get medical help right away if||
1563|082|S|any of these side effects occur: sudden vision changes (such as||
1563|083|S|decreased vision, blurred vision), eye pain/redness.||
1563|084|S|   This medication can rarely cause a serious metabolic problem||
1563|085|S|(high amount of ammonia in the blood), especially if you are also||
1563|086|S|taking valproic acid. Tell your doctor right away if you||
1563|087|S|experience sudden/unexplained tiredness, vomiting, or mental||
1563|088|S|changes (such as decreased alertness).||
1563|089|S|   A very serious allergic reaction to this drug is rare.||
1563|090|S|However, get medical help right away if you notice any symptoms||
1563|091|S|of a serious allergic reaction, including: rash, itching/swelling||
1563|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1563|093|S|breathing.||
1563|094|S|   This is not a complete list of possible side effects. If you||
1563|095|S|notice other effects not listed above, contact your doctor or||
1563|096|S|pharmacist.||
1563|097|S|   In the US -||
1563|098|S|   Call your doctor for medical advice about side effects. You||
1563|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1563|100|S|www.fda.gov/medwatch.||
1563|101|S|   In Canada - Call your doctor for medical advice about side||
1563|102|S|effects. You may report side effects to Health Canada at||
1563|103|S|1-866-234-2345.||
1563|104|B|||
1563|105|P|PRECAUTIONS:  Before taking topiramate, tell your doctor or||
1563|106|P|pharmacist if you are allergic to it; or if you have any other||
1563|107|P|allergies. This product may contain inactive ingredients, which||
1563|108|P|can cause allergic reactions or other problems. Talk to your||
1563|109|P|pharmacist for more details.||
1563|110|P|   Before using this medication, tell your doctor or pharmacist||
1563|111|P|your medical history, especially of: glaucoma, kidney problems||
1563|112|P|(such as kidney stones), liver problems, lung/breathing problems,||
1563|113|P|mental/mood problems (such as depression, thoughts of suicide), a||
1563|114|P|certain metabolic imbalance (metabolic acidosis), a diet high in||
1563|115|P|fat and low in carbohydrates (ketogenic diet), weak/brittle bones||
1563|116|P|(osteoporosis).||
1563|117|P|   This drug may make you dizzy or drowsy or affect your||
1563|118|P|thinking/coordination. Alcohol or marijuana (cannabis) can worsen||
1563|119|P|these effects. Do not drive, use machinery, or do anything that||
1563|120|P|needs alertness until you can do it safely. Avoid alcoholic||
1563|121|P|beverages. Talk to your doctor if you are using marijuana||
1563|122|P|(cannabis).||
1563|123|P|   This medication may make you sweat less, making you more||
1563|124|P|likely to get heat stroke. Avoid doing things that may cause you||
1563|125|P|to overheat, such as hard work or exercise in hot weather, or||
1563|126|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1563|127|P|and dress lightly. If you overheat, quickly look for a place to||
1563|128|P|cool down and rest. Get medical help right away if you have a||
1563|129|P|fever that does not go away, mental/mood changes, headache, or||
1563|130|P|dizziness.||
1563|131|P|   Before having surgery, tell your doctor or dentist about all||
1563|132|P|the products you use (including prescription drugs,||
1563|133|P|nonprescription drugs, and herbal products).||
1563|134|P|   Children may be more sensitive to the side effects of this||
1563|135|P|drug, especially weakened bones, slowed growth rate, and||
1563|136|P|decreased sweating. Consult your doctor or pharmacist for more||
1563|137|P|details.||
1563|138|P|   Older adults may be more sensitive to the side effects of this||
1563|139|P|drug, especially dizziness. Dizziness can increase the risk of||
1563|140|P|falling.||
1563|141|P|   During pregnancy, this medication should be used only when||
1563|142|P|clearly needed. It may harm an unborn baby. However, if you are||
1563|143|P|taking this drug to treat seizures, note that untreated seizures||
1563|144|P|are a serious condition that can harm both a pregnant woman and||
1563|145|P|her unborn baby, so do not stop taking this medication unless||
1563|146|P|directed by your doctor. Discuss the use of reliable forms of||
1563|147|P|birth control with your doctor (see also Drug Interactions||
1563|148|P|section). If you are planning pregnancy, become pregnant, or||
1563|149|P|think you may be pregnant, immediately talk to your doctor about||
1563|150|P|the benefits and risks of using this medication during pregnancy.||
1563|151|P|   This medication passes into breast milk and may have||
1563|152|P|undesirable effects on a nursing infant. Consult your doctor||
1563|153|P|before breastfeeding.||
1563|154|B|||
1563|155|I|DRUG INTERACTIONS:  See also Side Effects section.||
1563|156|I|   Drug interactions may change how your medications work or||
1563|157|I|increase your risk for serious side effects. This document does||
1563|158|I|not contain all possible drug interactions. Keep a list of all||
1563|159|I|the products you use (including prescription/nonprescription||
1563|160|I|drugs and herbal products) and share it with your doctor and||
1563|161|I|pharmacist. Do not start, stop, or change the dosage of any||
1563|162|I|medicines without your doctor's approval.||
1563|163|I|   A product that may interact with this drug is: orlistat.||
1563|164|I|   This medication may decrease the effectiveness of hormonal||
1563|165|I|birth control such as pills, patch, or ring. This could cause||
1563|166|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1563|167|I|use reliable backup birth control methods while using this||
1563|168|I|medication. Also tell your doctor if you have any new spotting or||
1563|169|I|breakthrough bleeding, because these may be signs that your birth||
1563|170|I|control is not working well.||
1563|171|I|   Tell your doctor or pharmacist if you are taking other||
1563|172|I|products that cause drowsiness including alcohol, marijuana||
1563|173|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1563|174|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1563|175|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
1563|176|I|codeine).||
1563|177|I|   Check the labels on all your medicines (such as allergy or||
1563|178|I|cough-and-cold products) because they may contain ingredients||
1563|179|I|that cause drowsiness. Ask your pharmacist about using those||
1563|180|I|products safely.||
1563|181|B|||
1563|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1563|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1563|184|O|poison control center right away. US residents can call||
1563|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1563|186|O|Symptoms of overdose may include: severe drowsiness, loss of||
1563|187|O|consciousness.||
1563|188|B|||
1563|189|N|NOTES:  Do not share this medication with others.||
1563|190|N|   Lab and/or medical tests (such as eye exams, bicarbonate blood||
1563|191|N|level) should be done while you are taking this medication. Keep||
1563|192|N|all medical and lab appointments.||
1563|193|B|||
1563|194|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1563|195|D|remember. If it is near the time of the next dose, skip the||
1563|196|D|missed dose. Take your next dose at the regular time. Do not||
1563|197|D|double the dose to catch up. If you have missed more than one||
1563|198|D|dose, ask your doctor or pharmacist for advice.||
1563|199|B|||
1563|200|R|STORAGE:  Store at room temperature away from light and moisture.||
1563|201|R|Do not store in the bathroom. Keep all medications away from||
1563|202|R|children and pets.||
1563|203|R|   Do not flush medications down the toilet or pour them into a||
1563|204|R|drain unless instructed to do so. Properly discard this product||
1563|205|R|when it is expired or no longer needed. Consult your pharmacist||
1563|206|R|or local waste disposal company.||
1563|207|B|||
1563|208|M|MEDICAL ALERT:  Your condition can cause complications in a||
1563|209|M|medical emergency. For information about enrolling in MedicAlert,||
1563|210|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1563|211|B|||
1563|212|A|Information last revised July 2025.||
1563|213|A|Copyright(c) 2025 First Databank, Inc.||
1563|214|B|||
1564|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1564|002|Z|does NOT have all possible information about this product. This||
1564|003|Z|information does not assure that this product is safe, effective,||
1564|004|Z|or appropriate for you. This information is not individual||
1564|005|Z|medical advice and does not substitute for the advice of your||
1564|006|Z|health care professional. Always ask your health care||
1564|007|Z|professional for complete information about this product and your||
1564|008|Z|specific health needs.||
1564|009|B|||
1564|010|T|BRIMONIDINE GEL - TOPICAL||
1564|011|F|(bri-MON-i-deen)||
1564|012|B|||
1564|013|C|COMMON BRAND NAME(S): Mirvaso||
1564|014|B|||
1564|015|U|USES:  This medication is used to treat a certain skin disorder||
1564|016|U|called rosacea. It works by narrowing blood vessels to reduce||
1564|017|U|redness. Brimonidine belongs to a class of drugs known as alpha||
1564|018|U|agonists.||
1564|019|B|||
1564|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
1564|021|H|Instructions for Use if available from your pharmacist before you||
1564|022|H|start using this drug and each time you get a refill. If you have||
1564|023|H|any questions, ask your doctor or pharmacist.||
1564|024|H|   This medication is for use on the skin only. Avoid getting||
1564|025|H|this medication into your eyes or mouth, on your lips, on any||
1564|026|H|areas of broken/irritated skin including after laser treatment,||
1564|027|H|or in and around the vaginal area.||
1564|028|H|   Wash your hands before and after applying this medication.||
1564|029|H|Clean and dry the affected area before applying the medication.||
1564|030|H|Apply a pea-sized amount of the medication to the affected||
1564|031|H|area(s) (such as the forehead, chin, nose, and each cheek) and||
1564|032|H|gently spread a thin layer of the medication over that area as||
1564|033|H|directed by your doctor, usually once daily.||
1564|034|H|   Use this medication regularly to get the most benefit from it.||
1564|035|H|To help you remember, use it at the same time each day.||
1564|036|H|   To reduce your risk of side effects, your doctor may direct||
1564|037|H|you to apply a smaller amount of medication at first and||
1564|038|H|gradually increase your dose. Follow your doctor's instructions||
1564|039|H|carefully.||
1564|040|H|   Tell your doctor if your condition does not get better or if||
1564|041|H|it gets worse.||
1564|042|H|   Keep this medicine in a safe place to prevent accidental use||
1564|043|H|or misuse. Children who have accidentally swallowed this||
1564|044|H|medication have had serious side effects, including trouble||
1564|045|H|breathing, weakness, slow heartbeat, confusion, sweating. If a||
1564|046|H|child swallows this drug, get medical help right away.||
1564|047|B|||
1564|048|S|SIDE EFFECTS:  Flushing and redness/burning of the skin may||
1564|049|S|occur. If any of these effects last or get worse, tell your||
1564|050|S|doctor or pharmacist promptly.||
1564|051|S|   Remember that this medication has been prescribed because your||
1564|052|S|doctor has judged that the benefit to you is greater than the||
1564|053|S|risk of side effects. Many people using this medication do not||
1564|054|S|have serious side effects.||
1564|055|S|   Tell your doctor right away if you have any serious side||
1564|056|S|effects, including: slow heartbeat, dizziness, fainting,||
1564|057|S|pale/whitening skin.||
1564|058|S|   A very serious allergic reaction to this drug is rare.||
1564|059|S|However, get medical help right away if you notice any symptoms||
1564|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1564|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1564|062|S|breathing.||
1564|063|S|   This is not a complete list of possible side effects. If you||
1564|064|S|notice other effects not listed above, contact your doctor or||
1564|065|S|pharmacist.||
1564|066|S|   In the US -||
1564|067|S|   Call your doctor for medical advice about side effects. You||
1564|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1564|069|S|www.fda.gov/medwatch.||
1564|070|S|   In Canada - Call your doctor for medical advice about side||
1564|071|S|effects. You may report side effects to Health Canada at||
1564|072|S|1-866-234-2345.||
1564|073|B|||
1564|074|P|PRECAUTIONS:  Before using brimonidine, tell your doctor or||
1564|075|P|pharmacist if you are allergic to it; or to apraclonidine; or if||
1564|076|P|you have any other allergies. This product may contain inactive||
1564|077|P|ingredients (such as phenoxyethanol), which can cause allergic||
1564|078|P|reactions or other problems. Talk to your pharmacist for more||
1564|079|P|details.||
1564|080|P|   Before using this medication, tell your doctor or pharmacist||
1564|081|P|your medical history, especially of: blood vessel diseases||
1564|082|P|(thromboangiitis obliterans), blood circulation disorders||
1564|083|P|(cerebral or coronary insufficiency), heart disease, depression,||
1564|084|P|Raynaud's disease, low blood pressure upon standing (orthostatic||
1564|085|P|hypotension), a certain immune system disorder (Sjogren's||
1564|086|P|syndrome), a certain skin/connective tissue disease||
1564|087|P|(scleroderma).||
1564|088|P|   Avoid certain triggers that may worsen rosacea such as wind,||
1564|089|P|hot beverages, spicy foods, alcohol, and extreme cold. Discuss||
1564|090|P|with your doctor.||
1564|091|P|   Sun exposure can worsen rosacea. Limit exposure to the sun by||
1564|092|P|wearing a wide-brimmed hat and using a sunscreen that is SPF 15||
1564|093|P|or greater.||
1564|094|P|   Before having surgery, tell your doctor or dentist about all||
1564|095|P|the products you use (including prescription drugs,||
1564|096|P|nonprescription drugs, and herbal products).||
1564|097|P|   During pregnancy, this medication should be used only when||
1564|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
1564|099|P|   It is unknown if this medication passes into breast milk.||
1564|100|P|Consult your doctor before breastfeeding.||
1564|101|B|||
1564|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1564|103|I|medications work or increase your risk for serious side effects.||
1564|104|I|This document does not contain all possible drug interactions.||
1564|105|I|Keep a list of all the products you use (including||
1564|106|I|prescription/nonprescription drugs and herbal products) and share||
1564|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1564|108|I|the dosage of any medicines without your doctor's approval.||
1564|109|I|   Avoid the use of skin care products that can cause further||
1564|110|I|irritation (such as cleaners that contain alcohol, tinctures,||
1564|111|I|astringents, abrasives, and peeling agents). Consult your doctor||
1564|112|I|or pharmacist for details.||
1564|113|B|||
1564|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1564|115|O|has overdosed and has serious symptoms such as passing out or||
1564|116|O|trouble breathing, call 911. Otherwise, call a poison control||
1564|117|O|center right away. US residents can call 1-800-222-1222. Canada||
1564|118|O|residents can call 1-844-764-7669.||
1564|119|B|||
1564|120|N|NOTES:  Do not share this medication with others.||
1564|121|N|   This medication has been prescribed for your current condition||
1564|122|N|only. Do not use it later for another condition unless your||
1564|123|N|doctor directs you to do so. A different medication may be||
1564|124|N|necessary in that case.||
1564|125|B|||
1564|126|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1564|127|D|If it is near the time of the next dose, skip the missed dose.||
1564|128|D|Use your next dose at the regular time. Do not double the dose to||
1564|129|D|catch up.||
1564|130|B|||
1564|131|R|STORAGE:  Store at room temperature. Keep all medications away||
1564|132|R|from children and pets.||
1564|133|R|   Do not flush medications down the toilet or pour them into a||
1564|134|R|drain unless instructed to do so. Properly discard this product||
1564|135|R|when it is expired or no longer needed. Consult your pharmacist||
1564|136|R|or local waste disposal company.||
1564|137|B|||
1564|138|A|Information last revised October 2024.||
1564|139|A|Copyright(c) 2025 First Databank, Inc.||
1564|140|B|||
1567|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1567|002|Z|does NOT have all possible information about this product. This||
1567|003|Z|information does not assure that this product is safe, effective,||
1567|004|Z|or appropriate for you. This information is not individual||
1567|005|Z|medical advice and does not substitute for the advice of your||
1567|006|Z|health care professional. Always ask your health care||
1567|007|Z|professional for complete information about this product and your||
1567|008|Z|specific health needs.||
1567|009|B|||
1567|010|T|DOSTARLIMAB - INJECTION||
1567|011|F|(dos-TAR-li-mab)||
1567|012|B|||
1567|013|C|COMMON BRAND NAME(S): Jemperli||
1567|014|B|||
1567|015|U|USES:  Dostarlimab is used to treat cancer of the uterus lining||
1567|016|U|(endometrial cancer). This medication is also used to treat||
1567|017|U|certain types of tumor (solid tumors). It works by changing the||
1567|018|U|action of your own immune system, directing it to attack||
1567|019|U|cancer/tumor cells. Dostarlimab belongs to a class of drugs known||
1567|020|U|as monoclonal antibodies.||
1567|021|B|||
1567|022|H|HOW TO USE:  Read the Medication Guide provided by your||
1567|023|H|pharmacist before you start receiving dostarlimab and each time||
1567|024|H|you get a treatment. If you have any questions, ask your doctor||
1567|025|H|or pharmacist.||
1567|026|H|   This medication is given by a health care professional. It is||
1567|027|H|injected slowly into a vein over 30 minutes. It is given as||
1567|028|H|directed by your doctor, usually once every 3 weeks for the first||
1567|029|H|4 or 6 doses and then once every 6 weeks.||
1567|030|H|   Infusion reactions may happen during the infusion of this||
1567|031|H|drug. Tell your doctor right away if you have symptoms of||
1567|032|H|infusion reaction such as nausea, fever, chills, flushing,||
1567|033|H|shortness of breath, dizziness, or fainting. Your doctor may give||
1567|034|H|you other medications to help with these side effects or may stop||
1567|035|H|your treatment for some time.||
1567|036|B|||
1567|037|S|SIDE EFFECTS:  See also How to Use section.||
1567|038|S|   Tiredness, diarrhea, or nausea may occur. If any of these||
1567|039|S|effects last or get worse, tell your doctor or pharmacist||
1567|040|S|promptly.||
1567|041|S|   People using this medication may have serious side effects.||
1567|042|S|However, you have been prescribed this drug because your doctor||
1567|043|S|has judged that the benefit to you is greater than the risk of||
1567|044|S|side effects. Careful monitoring by your doctor may decrease your||
1567|045|S|risk.||
1567|046|S|   Tell your doctor right away if you have any serious side||
1567|047|S|effects, including: new/worsening cough, diarrhea with||
1567|048|S|blood/mucus, severe stomach/abdominal pain, mouth/throat sores,||
1567|049|S|symptoms of liver disease (such as nausea/vomiting that doesn't||
1567|050|S|stop, loss of appetite, yellowing eyes/skin, dark urine), signs||
1567|051|S|of kidney problems (such as change in the amount of urine,||
1567|052|S|pink/bloody urine), easy bruising/bleeding, swelling||
1567|053|S|hands/ankles/feet, unusual weakness, joint stiffness/pain, muscle||
1567|054|S|weakness/tenderness/pain/spasms/cramps, numbness/tingling of||
1567|055|S|arms/legs, loss of coordination, eye redness/pain, sensitivity to||
1567|056|S|light, vision changes, headache that is unusual or doesn't go||
1567|057|S|away, seizures.||
1567|058|S|   Dostarlimab may cause hormone gland problems (such as thyroid,||
1567|059|S|pituitary, adrenal, pancreas). Your body could make too much or||
1567|060|S|too little hormone. Tell your doctor right away if you have any||
1567|061|S|symptoms such as: cold or heat intolerance, unexplained weight||
1567|062|S|loss/gain, increased thirst/urination, mood or behavior changes||
1567|063|S|(such as decreased sex drive, irritability, forgetfulness),||
1567|064|S|slow/fast/pounding/irregular heartbeat, unusual tiredness,||
1567|065|S|constipation.||
1567|066|S|   Get medical help right away if you have any very serious side||
1567|067|S|effects, including: chest pain, shortness of breath.||
1567|068|S|   Dostarlimab can commonly cause itching or a rash that is||
1567|069|S|usually not serious. However, you may not be able to tell it||
1567|070|S|apart from a rare rash that could be a sign of a severe reaction.||
1567|071|S|Get medical help right away if you develop any rash or itching.||
1567|072|S|   A very serious allergic reaction to this drug is rare.||
1567|073|S|However, get medical help right away if you notice any symptoms||
1567|074|S|of a serious allergic reaction, including: fever, swollen lymph||
1567|075|S|nodes, rash, itching/swelling (especially of the||
1567|076|S|face/tongue/throat), severe dizziness, trouble breathing.||
1567|077|S|   This is not a complete list of possible side effects. If you||
1567|078|S|notice other effects not listed above, contact your doctor or||
1567|079|S|pharmacist.||
1567|080|S|   In the US -||
1567|081|S|   Call your doctor for medical advice about side effects. You||
1567|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1567|083|S|www.fda.gov/medwatch.||
1567|084|S|   In Canada - Call your doctor for medical advice about side||
1567|085|S|effects. You may report side effects to Health Canada at||
1567|086|S|1-866-234-2345.||
1567|087|B|||
1567|088|P|PRECAUTIONS:  Before using dostarlimab, tell your doctor or||
1567|089|P|pharmacist if you are allergic to it; or if you have any other||
1567|090|P|allergies. This product may contain inactive ingredients, which||
1567|091|P|can cause allergic reactions or other problems. Talk to your||
1567|092|P|pharmacist for more details.||
1567|093|P|   Before using this medication, tell your doctor or pharmacist||
1567|094|P|your medical history, especially of: organ transplant, stem cell||
1567|095|P|transplant with donor cells.||
1567|096|P|   Before having surgery, tell your doctor or dentist about all||
1567|097|P|the products you use (including prescription drugs,||
1567|098|P|nonprescription drugs, and herbal products).||
1567|099|P|   Tell your doctor if you are pregnant or plan to become||
1567|100|P|pregnant. You should not become pregnant while using dostarlimab.||
1567|101|P|Dostarlimab may harm an unborn baby. Your doctor should order a||
1567|102|P|pregnancy test before you start this medication. Ask about||
1567|103|P|reliable forms of birth control while using this medication and||
1567|104|P|for 4 months after the last dose. If you become pregnant, talk to||
1567|105|P|your doctor right away about the risks and benefits of this||
1567|106|P|medication.||
1567|107|P|   It is unknown if this drug passes into breast milk. Because of||
1567|108|P|the possible risk to the infant, breastfeeding is not recommended||
1567|109|P|while using this drug and for 4 months after the last dose.||
1567|110|P|Consult your doctor before breastfeeding.||
1567|111|B|||
1567|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1567|113|I|medications work or increase your risk for serious side effects.||
1567|114|I|This document does not contain all possible drug interactions.||
1567|115|I|Keep a list of all the products you use (including||
1567|116|I|prescription/nonprescription drugs and herbal products) and share||
1567|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
1567|118|I|the dosage of any medicines without your doctor's approval.||
1567|119|B|||
1567|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1567|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1567|122|O|poison control center right away. US residents can call||
1567|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1567|124|B|||
1567|125|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
1567|126|N|function, blood sugar) should be done before and during treatment||
1567|127|N|with this medication. Keep all medical and lab appointments.||
1567|128|N|Consult your doctor for more details.||
1567|129|B|||
1567|130|D|MISSED DOSE:  It is important to get each dose of this medication||
1567|131|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1567|132|D|right away for a new dosing schedule.||
1567|133|B|||
1567|134|R|STORAGE:  Not applicable. This medication is given in a hospital||
1567|135|R|or clinic and will not be stored at home.||
1567|136|B|||
1567|137|A|Information last revised May 2024.||
1567|138|A|Copyright(c) 2025 First Databank, Inc.||
1567|139|B|||
1568|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1568|002|Z|does NOT have all possible information about this product. This||
1568|003|Z|information does not assure that this product is safe, effective,||
1568|004|Z|or appropriate for you. This information is not individual||
1568|005|Z|medical advice and does not substitute for the advice of your||
1568|006|Z|health care professional. Always ask your health care||
1568|007|Z|professional for complete information about this product and your||
1568|008|Z|specific health needs.||
1568|009|B|||
1568|010|T|VORTIOXETINE - ORAL||
1568|011|F|(VOR-tye-OX-e-teen)||
1568|012|B|||
1568|013|C|COMMON BRAND NAME(S): Trintellix||
1568|014|B|||
1568|015|W|WARNING:  Antidepressant medications are used to treat a variety||
1568|016|W|of conditions, including depression and other mental/mood||
1568|017|W|disorders. These medications can help prevent suicidal||
1568|018|W|thoughts/attempts and provide other important benefits. However,||
1568|019|W|studies have shown that a small number of people (especially||
1568|020|W|people younger than 25) who take antidepressants for any||
1568|021|W|condition may experience worsening depression, other mental/mood||
1568|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
1568|023|W|talk with the doctor about the risks and benefits of||
1568|024|W|antidepressant medication (especially for people younger than||
1568|025|W|25), even if treatment is not for a mental/mood condition.||
1568|026|W|   Tell the doctor right away if you notice worsening||
1568|027|W|depression/other psychiatric conditions, unusual behavior changes||
1568|028|W|(including possible suicidal thoughts/attempts), or other||
1568|029|W|mental/mood changes (including new/worsening anxiety, panic||
1568|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1568|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
1568|032|W|especially watchful for these symptoms when a new antidepressant||
1568|033|W|is started or when the dose is changed.||
1568|034|B|||
1568|035|U|USES:  This medication is used to treat depression. Vortioxetine||
1568|036|U|works by helping to restore the balance of a certain natural||
1568|037|U|substance (serotonin) in the brain.||
1568|038|B|||
1568|039|H|HOW TO USE:  Read the Medication Guide provided by your||
1568|040|H|pharmacist before you start taking vortioxetine and each time you||
1568|041|H|get a refill. If you have any questions, ask your doctor or||
1568|042|H|pharmacist.||
1568|043|H|   Take this medication by mouth with or without food as directed||
1568|044|H|by your doctor, usually once daily. The dosage is based on your||
1568|045|H|medical condition, response to treatment and other medications||
1568|046|H|you may be taking. Be sure to tell your doctor and pharmacist||
1568|047|H|about all the products you use (including prescription drugs,||
1568|048|H|nonprescription drugs, and herbal products).||
1568|049|H|   To reduce your risk of side effects, your doctor may direct||
1568|050|H|you to start this medication at a low dose and gradually increase||
1568|051|H|your dose. Follow your doctor's instructions carefully. Do not||
1568|052|H|increase your dose or use this drug more often or for longer than||
1568|053|H|prescribed. Your condition will not improve any faster, and your||
1568|054|H|risk of side effects will increase. Use this medication regularly||
1568|055|H|to get the most benefit from it. To help you remember, take it at||
1568|056|H|the same time each day.||
1568|057|H|   Keep taking this medication even if you feel well. Do not stop||
1568|058|H|taking this medication without consulting your doctor. Some||
1568|059|H|conditions may become worse when this drug is suddenly stopped.||
1568|060|H|Also, you may experience symptoms such as mood swings, headache,||
1568|061|H|muscle stiffness, and runny nose. To prevent these symptoms while||
1568|062|H|you are stopping treatment with this drug, your doctor may reduce||
1568|063|H|your dose gradually. Consult your doctor or pharmacist for more||
1568|064|H|details. Report any new or worsening symptoms right away.||
1568|065|H|   It may take up to several weeks before you get the full||
1568|066|H|benefit of this drug.||
1568|067|H|   Tell your doctor if your condition does not get better or if||
1568|068|H|it gets worse.||
1568|069|B|||
1568|070|S|SIDE EFFECTS:  See also Warning section.||
1568|071|S|   Nausea, constipation, vomiting, and dizziness may occur. If||
1568|072|S|any of these effects last or get worse, tell your doctor or||
1568|073|S|pharmacist promptly.||
1568|074|S|   Remember that this medication has been prescribed because your||
1568|075|S|doctor has judged that the benefit to you is greater than the||
1568|076|S|risk of side effects. Many people using this medication do not||
1568|077|S|have serious side effects.||
1568|078|S|   Tell your doctor right away if you have any serious side||
1568|079|S|effects, including: shaking (tremor), restlessness, inability to||
1568|080|S|keep still, changes in sexual ability, decreased interest in sex,||
1568|081|S|numbness/tingling, easy bleeding/bruising, difficulty||
1568|082|S|concentrating, memory changes, confusion, weakness.||
1568|083|S|   Get medical help right away if you have any very serious side||
1568|084|S|effects, including: seizures, black stools, vomit that looks like||
1568|085|S|coffee grounds, eye pain/swelling/redness, widened pupils, vision||
1568|086|S|changes (such as seeing rainbows around lights at night, blurred||
1568|087|S|vision).||
1568|088|S|   This medication may increase serotonin and rarely cause a very||
1568|089|S|serious condition called serotonin syndrome/toxicity. The risk||
1568|090|S|increases if you are also taking other drugs that increase||
1568|091|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1568|092|S|take (see Drug Interactions section). Get medical help right away||
1568|093|S|if you develop some of the following symptoms: fast heartbeat,||
1568|094|S|hallucinations, loss of coordination, severe dizziness, severe||
1568|095|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1568|096|S|unusual agitation/restlessness.||
1568|097|S|   A very serious allergic reaction to this drug is rare.||
1568|098|S|However, get medical help right away if you notice any symptoms||
1568|099|S|of a serious allergic reaction, including: rash, itching/swelling||
1568|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1568|101|S|breathing.||
1568|102|S|   This is not a complete list of possible side effects. If you||
1568|103|S|notice other effects not listed above, contact your doctor or||
1568|104|S|pharmacist.||
1568|105|S|   In the US -||
1568|106|S|   Call your doctor for medical advice about side effects. You||
1568|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1568|108|S|www.fda.gov/medwatch.||
1568|109|S|   In Canada - Call your doctor for medical advice about side||
1568|110|S|effects. You may report side effects to Health Canada at||
1568|111|S|1-866-234-2345.||
1568|112|B|||
1568|113|P|PRECAUTIONS:  Before taking vortioxetine, tell your doctor or||
1568|114|P|pharmacist if you are allergic to it; or if you have any other||
1568|115|P|allergies. This product may contain inactive ingredients, which||
1568|116|P|can cause allergic reactions or other problems. Talk to your||
1568|117|P|pharmacist for more details.||
1568|118|P|   Before using this medication, tell your doctor or pharmacist||
1568|119|P|your medical history, especially of: personal or family history||
1568|120|P|of bipolar/manic-depressive disorder, personal or family history||
1568|121|P|of suicide attempts, seizures, low sodium in the blood, bleeding||
1568|122|P|problems, personal or family history of glaucoma (angle-closure||
1568|123|P|type).||
1568|124|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1568|125|P|can make you more dizzy. Do not drive, use machinery, or do||
1568|126|P|anything that needs alertness until you can do it safely. Avoid||
1568|127|P|alcoholic beverages. Talk to your doctor if you are using||
1568|128|P|marijuana (cannabis).||
1568|129|P|   Before having surgery, tell your doctor or dentist about all||
1568|130|P|the products you use (including prescription drugs,||
1568|131|P|nonprescription drugs, and herbal products).||
1568|132|P|   Older adults may be more sensitive to the side effects of this||
1568|133|P|drug, especially bleeding. Older adults may also be more likely||
1568|134|P|to develop a type of salt imbalance (hyponatremia), especially if||
1568|135|P|they are also taking "water pills" (diuretics) with this||
1568|136|P|medication.||
1568|137|P|   During pregnancy, this medication should be used only when||
1568|138|P|clearly needed. It may harm an unborn baby. Also, babies born to||
1568|139|P|mothers who have used this drug during the last 3 months of||
1568|140|P|pregnancy may rarely develop withdrawal symptoms such as||
1568|141|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
1568|142|P|constant crying. If you notice any of these symptoms in your||
1568|143|P|newborn, tell the doctor promptly.||
1568|144|P|   Since untreated mental/mood problems (such as depression) can||
1568|145|P|be a serious condition, do not stop taking this medication unless||
1568|146|P|directed by your doctor. If you are planning pregnancy, become||
1568|147|P|pregnant, or think you may be pregnant, immediately discuss with||
1568|148|P|your doctor the benefits and risks of using this medication||
1568|149|P|during pregnancy.||
1568|150|P|   It is unknown if this drug passes into breast milk. Consult||
1568|151|P|your doctor before breastfeeding.||
1568|152|B|||
1568|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1568|154|I|medications work or increase your risk for serious side effects.||
1568|155|I|This document does not contain all possible drug interactions.||
1568|156|I|Keep a list of all the products you use (including||
1568|157|I|prescription/nonprescription drugs and herbal products) and share||
1568|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
1568|159|I|the dosage of any medicines without your doctor's approval.||
1568|160|I|   Some products that may interact with this drug are: other||
1568|161|I|drugs that can cause bleeding/bruising (including antiplatelet||
1568|162|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
1568|163|I|"blood thinners" such as dabigatran/warfarin).||
1568|164|I|   Aspirin can increase the risk of bleeding when used with this||
1568|165|I|medication. However, if your doctor has told you to take low-dose||
1568|166|I|aspirin to prevent heart attack or stroke (usually 81-162||
1568|167|I|milligrams a day), you should keep taking the aspirin unless your||
1568|168|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1568|169|I|details.||
1568|170|I|   Taking MAO inhibitors with this medication may cause a serious||
1568|171|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
1568|172|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1568|173|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1568|174|I|selegiline, tranylcypromine) during treatment with this||
1568|175|I|medication. Most MAO inhibitors should also not be taken for 2||
1568|176|I|weeks before and 21 days after treatment with this medication.||
1568|177|I|Ask your doctor when to start or stop taking this medication.||
1568|178|I|   The risk of serotonin syndrome/toxicity increases if you are||
1568|179|I|also taking other drugs that increase serotonin. Examples include||
1568|180|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1568|181|I|antidepressants (including other SSRIs such as||
1568|182|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
1568|183|I|among others. The risk of serotonin syndrome/toxicity may be more||
1568|184|I|likely when you start or increase the dose of these drugs.||
1568|185|B|||
1568|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1568|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1568|188|O|poison control center right away. US residents can call||
1568|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1568|190|B|||
1568|191|N|NOTES:  Do not share this medication with others.||
1568|192|N|   Keep all medical and lab appointments.||
1568|193|B|||
1568|194|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1568|195|D|remember. If it is near the time of the next dose, skip the||
1568|196|D|missed dose. Take your next dose at the regular time. Do not||
1568|197|D|double the dose to catch up.||
1568|198|B|||
1568|199|R|STORAGE:  Store at room temperature away from light and moisture.||
1568|200|R|Do not store in the bathroom. Keep all medications away from||
1568|201|R|children and pets.||
1568|202|R|   Do not flush medications down the toilet or pour them into a||
1568|203|R|drain unless instructed to do so. Properly discard this product||
1568|204|R|when it is expired or no longer needed. Consult your pharmacist||
1568|205|R|or local waste disposal company.||
1568|206|B|||
1568|207|A|Information last revised July 2025.||
1568|208|A|Copyright(c) 2025 First Databank, Inc.||
1568|209|B|||
1569|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1569|002|Z|does NOT have all possible information about this product. This||
1569|003|Z|information does not assure that this product is safe, effective,||
1569|004|Z|or appropriate for you. This information is not individual||
1569|005|Z|medical advice and does not substitute for the advice of your||
1569|006|Z|health care professional. Always ask your health care||
1569|007|Z|professional for complete information about this product and your||
1569|008|Z|specific health needs.||
1569|009|B|||
1569|010|T|RIOCIGUAT - ORAL||
1569|011|F|(RYE-oh-SIG-ue-at)||
1569|012|B|||
1569|013|C|COMMON BRAND NAME(S): Adempas||
1569|014|B|||
1569|015|W|WARNING:  Riociguat must not be used during pregnancy. It may||
1569|016|W|harm an unborn baby. It is important to prevent pregnancy while||
1569|017|W|taking this medication and for 1 month after treatment. Female||
1569|018|W|patients must use reliable birth control during treatment and for||
1569|019|W|1 month after the end of treatment. Ask your doctor which forms||
1569|020|W|of birth control to use while taking this medication. Female||
1569|021|W|patients must take a pregnancy test before starting treatment,||
1569|022|W|take a monthly pregnancy test during treatment, and take a||
1569|023|W|pregnancy test 1 month after the end of treatment. If you become||
1569|024|W|pregnant or think you may be pregnant, tell your doctor right||
1569|025|W|away.||
1569|026|W|   To receive riociguat in the United States, you must||
1569|027|W|understand, agree to, and carefully follow the requirements of||
1569|028|W|the REMS Program for this medication. If you live in Canada or||
1569|029|W|any other country, consult your doctor and pharmacist for your||
1569|030|W|country's regulations.||
1569|031|B|||
1569|032|U|USES:  Riociguat is used to treat high blood pressure in the||
1569|033|U|lungs (pulmonary hypertension). It can also be used to treat a||
1569|034|U|certain type of high blood pressure in the lungs caused by blood||
1569|035|U|clots (chronic thromboembolic pulmonary hypertension) when||
1569|036|U|surgery has not been fully successful or is impossible. Riociguat||
1569|037|U|works by relaxing and widening the blood vessels in your lungs so||
1569|038|U|blood can flow more easily. Decreasing high blood pressure in the||
1569|039|U|lungs allows your heart and lungs to work better and improves||
1569|040|U|your ability to exercise.||
1569|041|B|||
1569|042|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1569|043|H|Patient Information Leaflet provided by your pharmacist before||
1569|044|H|you start taking riociguat and each time you get a refill. If you||
1569|045|H|have any questions, ask your doctor or pharmacist.||
1569|046|H|   Take this medication by mouth with or without food as directed||
1569|047|H|by your doctor, usually 3 times daily. The dosage is based on||
1569|048|H|your medical condition, response to treatment, and other||
1569|049|H|medications you may be taking. Be sure to tell your doctor and||
1569|050|H|pharmacist about all the products you use (including prescription||
1569|051|H|drugs, nonprescription drugs, and herbal products).||
1569|052|H|   Take this medication 1 hour before or after taking antacids||
1569|053|H|that contain aluminum or magnesium. These products prevent your||
1569|054|H|body from fully absorbing riociguat.||
1569|055|H|   To reduce your risk of side effects (such as low blood||
1569|056|H|pressure), your doctor may direct you to start this medication at||
1569|057|H|a low dose and gradually increase your dose. Follow your doctor's||
1569|058|H|instructions carefully.||
1569|059|H|   Use this medication regularly to get the most benefit from it.||
1569|060|H|To help you remember, take it at the same times each day.||
1569|061|H|   Do not increase your dose or use this drug more often than||
1569|062|H|prescribed. Your condition will not improve any faster, and your||
1569|063|H|risk of side effects will increase.||
1569|064|H|   Tell your doctor if your condition does not get better or if||
1569|065|H|it gets worse.||
1569|066|B|||
1569|067|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, fainting,||
1569|068|S|unusual tiredness, heartburn, indigestion, nausea, vomiting, or||
1569|069|S|diarrhea may occur. If any of these effects last or get worse,||
1569|070|S|tell your doctor or pharmacist promptly.||
1569|071|S|   To reduce the risk of dizziness and lightheadedness, get up||
1569|072|S|slowly when rising from a sitting or lying position.||
1569|073|S|   Remember that this medication has been prescribed because your||
1569|074|S|doctor has judged that the benefit to you is greater than the||
1569|075|S|risk of side effects. Many people using this medication do not||
1569|076|S|have serious side effects.||
1569|077|S|   This medication has rarely caused serious bleeding. If you||
1569|078|S|notice any of the following unlikely but serious signs of||
1569|079|S|bleeding, tell your doctor right away: unusual bleeding from the||
1569|080|S|vagina, coughing up blood, bleeding around catheter site, signs||
1569|081|S|of stomach/intestinal bleeding (such as black/bloody stools,||
1569|082|S|vomit that contains blood or looks like coffee grounds), signs of||
1569|083|S|bleeding in the brain (such as severe headache, weakness on one||
1569|084|S|side of the body, vision problems, trouble speaking, confusion).||
1569|085|S|   A very serious allergic reaction to this drug is rare.||
1569|086|S|However, get medical help right away if you notice any symptoms||
1569|087|S|of a serious allergic reaction, including: rash, itching/swelling||
1569|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1569|089|S|breathing.||
1569|090|S|   This is not a complete list of possible side effects. If you||
1569|091|S|notice other effects not listed above, contact your doctor or||
1569|092|S|pharmacist.||
1569|093|S|   In the US -||
1569|094|S|   Call your doctor for medical advice about side effects. You||
1569|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1569|096|S|www.fda.gov/medwatch.||
1569|097|S|   In Canada - Call your doctor for medical advice about side||
1569|098|S|effects. You may report side effects to Health Canada at||
1569|099|S|1-866-234-2345.||
1569|100|B|||
1569|101|P|PRECAUTIONS:  Before taking riociguat, tell your doctor or||
1569|102|P|pharmacist if you are allergic to it; or if you have any other||
1569|103|P|allergies. This product may contain inactive ingredients, which||
1569|104|P|can cause allergic reactions or other problems. Talk to your||
1569|105|P|pharmacist for more details.||
1569|106|P|   Before using this medication, tell your doctor or pharmacist||
1569|107|P|your medical history, especially of: smoking or history of||
1569|108|P|smoking, low or high blood pressure, other lung conditions (such||
1569|109|P|as pulmonary veno-occlusive disease, idiopathic interstitial||
1569|110|P|pneumonia), dehydration, a severe blockage of blood flow out of||
1569|111|P|the heart.||
1569|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1569|113|P|can make you more dizzy. Do not drive, use machinery, or do||
1569|114|P|anything that needs alertness until you can do it safely. Limit||
1569|115|P|alcoholic beverages. Talk to your doctor if you are using||
1569|116|P|marijuana (cannabis).||
1569|117|P|   Before having surgery, tell your doctor or dentist about all||
1569|118|P|the products you use (including prescription drugs,||
1569|119|P|nonprescription drugs, and herbal products).||
1569|120|P|   This medication must not be used during pregnancy. It may harm||
1569|121|P|an unborn baby. See also Warning section.||
1569|122|P|   It is unknown if this medication passes into breast milk.||
1569|123|P|Consult your doctor before breastfeeding.||
1569|124|B|||
1569|125|I|DRUG INTERACTIONS:  See also How To Use section.||
1569|126|I|   Drug interactions may change how your medications work or||
1569|127|I|increase your risk for serious side effects. This document does||
1569|128|I|not contain all possible drug interactions. Keep a list of all||
1569|129|I|the products you use (including prescription/nonprescription||
1569|130|I|drugs and herbal products) and share it with your doctor and||
1569|131|I|pharmacist. Do not start, stop, or change the dosage of any||
1569|132|I|medicines without your doctor's approval.||
1569|133|I|   Some products that may interact with this drug include:||
1569|134|I|aminophylline, certain drugs used to treat chest pain/angina or||
1569|135|I|high blood pressure (nitrates such as nitroglycerin, isosorbide),||
1569|136|I|dipyridamole, drugs to treat erectile dysfunction-ED/pulmonary||
1569|137|I|hypertension (such as sildenafil, tadalafil, vardenafil),||
1569|138|I|recreational drugs called "poppers" containing amyl or butyl||
1569|139|I|nitrite, theophylline, vericiguat.||
1569|140|I|   Cigarette smoking decreases blood levels of this medication.||
1569|141|I|Tell your doctor if you smoke or if you have recently stopped||
1569|142|I|smoking.||
1569|143|B|||
1569|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1569|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1569|146|O|poison control center right away. US residents can call||
1569|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1569|148|B|||
1569|149|N|NOTES:  Do not share this medication with others.||
1569|150|N|   Lab and/or medical tests (such as blood pressure, pregnancy||
1569|151|N|tests) must be done while you are taking this medication. Keep||
1569|152|N|all medical and lab appointments. Consult your doctor for more||
1569|153|N|details.||
1569|154|B|||
1569|155|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1569|156|D|next dose at the regular time. Do not double the dose to catch||
1569|157|D|up. Check with your doctor if you miss doses for more than 3 days||
1569|158|D|in a row.||
1569|159|B|||
1569|160|R|STORAGE:  Store at room temperature away from light and moisture.||
1569|161|R|Do not store in the bathroom. Keep all medications away from||
1569|162|R|children and pets.||
1569|163|R|   Do not flush medications down the toilet or pour them into a||
1569|164|R|drain unless instructed to do so. Properly discard this product||
1569|165|R|when it is expired or no longer needed. Consult your pharmacist||
1569|166|R|or local waste disposal company.||
1569|167|B|||
1569|168|A|Information last revised October 2024.||
1569|169|A|Copyright(c) 2025 First Databank, Inc.||
1569|170|B|||
1570|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1570|002|Z|does NOT have all possible information about this product. This||
1570|003|Z|information does not assure that this product is safe, effective,||
1570|004|Z|or appropriate for you. This information is not individual||
1570|005|Z|medical advice and does not substitute for the advice of your||
1570|006|Z|health care professional. Always ask your health care||
1570|007|Z|professional for complete information about this product and your||
1570|008|Z|specific health needs.||
1570|009|B|||
1570|010|T|MECHLORETHAMINE - TOPICAL||
1570|011|F|(ME-klor-ETH-a-meen)||
1570|012|B|||
1570|013|C|COMMON BRAND NAME(S): Valchlor||
1570|014|B|||
1570|015|U|USES:  This medication is used on the skin to treat a certain||
1570|016|U|type of cancer (cutaneous T-cell lymphoma). Mechlorethamine||
1570|017|U|belongs to a class of drugs known as alkylating agents. It works||
1570|018|U|by slowing or stopping the growth of cancer cells that cause the||
1570|019|U|skin condition.||
1570|020|B|||
1570|021|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1570|022|H|Patient Information Leaflet provided by your pharmacist before||
1570|023|H|you start using mechlorethamine and each time you get a refill.||
1570|024|H|If you have any questions, ask your doctor or pharmacist.||
1570|025|H|   Use this medication as directed by your doctor, usually once a||
1570|026|H|day. After taking this medication out of the refrigerator, apply||
1570|027|H|it within 30 minutes, and be sure to return it to the||
1570|028|H|refrigerator right after each use. Apply a small amount of||
1570|029|H|medication to completely dry skin at least 4 hours before or 30||
1570|030|H|minutes after showering or washing. Let the treated area(s) dry||
1570|031|H|for 5 to 10 minutes before covering with clothing. You may apply||
1570|032|H|moisturizers to the treated area(s) 2 hours before or 2 hours||
1570|033|H|after applying mechlorethamine.||
1570|034|H|   If someone helps you apply this medication, they must wear||
1570|035|H|disposable gloves. If you are applying it to yourself, you can||
1570|036|H|wear disposable gloves but you do not have to. After applying,||
1570|037|H|wash your hands right away, even if you have worn gloves (see||
1570|038|H|also Side Effects section). Safely throw away any used gloves in||
1570|039|H|the trash.||
1570|040|H|   Do not cover the treated area with tight dressings or plastic||
1570|041|H|bandages. Ask your doctor whether you may cover the treated area||
1570|042|H|loosely with gauze.||
1570|043|H|   Avoid getting this medication in or around the eyes or||
1570|044|H|eyelids. It can cause pain, burns, blurred vision, and even||
1570|045|H|blindness. Also, do not apply this medication inside the nose or||
1570|046|H|mouth. If you accidentally get this medication in the eyes, rinse||
1570|047|H|for at least 15 minutes with plenty of water, normal saline, or||
1570|048|H|an eye wash solution and get medical help right away (including||
1570|049|H|exam by an eye doctor). If you get this medication in the nose or||
1570|050|H|mouth, rinse for at least 15 minutes with plenty of water and||
1570|051|H|tell the doctor right away.||
1570|052|H|   Use this medication exactly as prescribed. Do not increase||
1570|053|H|your dose or use this drug more often than directed. Your||
1570|054|H|condition will not improve any faster, and your risk of side||
1570|055|H|effects will increase.||
1570|056|H|   This medication is flammable until dry. Avoid smoking or being||
1570|057|H|near open flames while using the medication and until the||
1570|058|H|medication has dried.||
1570|059|H|   Tell your doctor if your condition does not get better or if||
1570|060|H|it gets worse.||
1570|061|B|||
1570|062|S|SIDE EFFECTS:  Skin irritation, itching, blisters, burning,||
1570|063|S|redness, pain, swelling, tenderness, or darkening of skin where||
1570|064|S|you have applied medication may occur. If any of these effects||
1570|065|S|last or get worse, tell your doctor or pharmacist promptly.||
1570|066|S|   Remember that this medication has been prescribed because your||
1570|067|S|doctor has judged that the benefit to you is greater than the||
1570|068|S|risk of side effects. Many people using this medication do not||
1570|069|S|have serious side effects.||
1570|070|S|   Tell your doctor right away if you have any serious side||
1570|071|S|effects, including: easy bruising/bleeding, signs of infection||
1570|072|S|(such as skin ulcers/pus, fever, chills).||
1570|073|S|   Very rarely, people who are treated with or who have had||
1570|074|S|contact with this medication have developed other skin cancers.||
1570|075|S|Tell your doctor right away if you, or someone who has helped you||
1570|076|S|apply this medication, notice any new skin lesions or unusual||
1570|077|S|skin changes. Ask your doctor for details.||
1570|078|S|   A very serious allergic reaction to this drug is rare.||
1570|079|S|However, get medical help right away if you notice any symptoms||
1570|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1570|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1570|082|S|breathing.||
1570|083|S|   This is not a complete list of possible side effects. If you||
1570|084|S|notice other effects not listed above, contact your doctor or||
1570|085|S|pharmacist.||
1570|086|S|   In the US -||
1570|087|S|   Call your doctor for medical advice about side effects. You||
1570|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1570|089|S|www.fda.gov/medwatch.||
1570|090|S|   In Canada - Call your doctor for medical advice about side||
1570|091|S|effects. You may report side effects to Health Canada at||
1570|092|S|1-866-234-2345.||
1570|093|B|||
1570|094|P|PRECAUTIONS:  Before using mechlorethamine, tell your doctor or||
1570|095|P|pharmacist if you are allergic to it; or if you have any other||
1570|096|P|allergies. This product may contain inactive ingredients, which||
1570|097|P|can cause allergic reactions or other problems. Talk to your||
1570|098|P|pharmacist for more details.||
1570|099|P|   Before using this medication, tell your doctor or pharmacist||
1570|100|P|your medical history, especially of: red/irritated/infected/open||
1570|101|P|sores on skin.||
1570|102|P|   Before having surgery, tell your doctor or dentist about all||
1570|103|P|the products you use (including prescription drugs,||
1570|104|P|nonprescription drugs, and herbal products).||
1570|105|P|   Tell your doctor if you are pregnant or plan to become||
1570|106|P|pregnant. You should not become pregnant while using||
1570|107|P|mechlorethamine. Mechlorethamine may harm an unborn baby. Men and||
1570|108|P|women using this medication should ask about reliable forms of||
1570|109|P|birth control during treatment. If you or your partner becomes||
1570|110|P|pregnant, talk to your doctor right away about the risks and||
1570|111|P|benefits of this medication.||
1570|112|P|   It is unknown if this medication passes into breast milk.||
1570|113|P|Because of the possible risk to the infant, breastfeeding is not||
1570|114|P|recommended while using this medication. Consult your doctor||
1570|115|P|before breastfeeding.||
1570|116|B|||
1570|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1570|118|I|medications work or increase your risk for serious side effects.||
1570|119|I|This document does not contain all possible drug interactions.||
1570|120|I|Keep a list of all the products you use (including||
1570|121|I|prescription/nonprescription drugs and herbal products) and share||
1570|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
1570|123|I|the dosage of any medicines without your doctor's approval.||
1570|124|B|||
1570|125|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1570|126|O|has overdosed and has serious symptoms such as passing out or||
1570|127|O|trouble breathing, call 911. Otherwise, call a poison control||
1570|128|O|center right away. US residents can call 1-800-222-1222. Canada||
1570|129|O|residents can call 1-844-764-7669.||
1570|130|B|||
1570|131|N|NOTES:  Do not share this medication with others.||
1570|132|N|   Lab and/or medical tests (such as hematocrit, complete blood||
1570|133|N|counts) may be done while you are using this medication. Keep all||
1570|134|N|medical and lab appointments.||
1570|135|B|||
1570|136|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1570|137|D|If it is near the time of the next dose, skip the missed dose.||
1570|138|D|Use your next dose at the regular time. Do not double the dose to||
1570|139|D|catch up.||
1570|140|B|||
1570|141|R|STORAGE:  Store in the original box in the refrigerator away from||
1570|142|R|food. This medication expires after 90 days. Keep all medications||
1570|143|R|away from children and pets.||
1570|144|R|   Do not flush medications down the toilet or pour them into a||
1570|145|R|drain unless instructed to do so. Properly discard this product||
1570|146|R|when it is expired or no longer needed. Consult your pharmacist||
1570|147|R|or local waste disposal company.||
1570|148|B|||
1570|149|A|Information last revised July 2025.||
1570|150|A|Copyright(c) 2025 First Databank, Inc.||
1570|151|B|||
1571|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1571|002|Z|does NOT have all possible information about this product. This||
1571|003|Z|information does not assure that this product is safe, effective,||
1571|004|Z|or appropriate for you. This information is not individual||
1571|005|Z|medical advice and does not substitute for the advice of your||
1571|006|Z|health care professional. Always ask your health care||
1571|007|Z|professional for complete information about this product and your||
1571|008|Z|specific health needs.||
1571|009|B|||
1571|010|T|MACITENTAN - ORAL||
1571|011|F|(MA-si-TEN-tan)||
1571|012|B|||
1571|013|C|COMMON BRAND NAME(S): Opsumit||
1571|014|B|||
1571|015|W|WARNING:  Macitentan must not be used during pregnancy. It may||
1571|016|W|harm an unborn baby. It is important to prevent pregnancy while||
1571|017|W|taking this medication and for 1 month after treatment. Female||
1571|018|W|patients must use reliable birth control before starting||
1571|019|W|treatment, during treatment, and for 1 month after the last dose.||
1571|020|W|Ask your doctor which forms of birth control to use while taking||
1571|021|W|this medication. Female patients must take a pregnancy test||
1571|022|W|before starting treatment. If you become pregnant or think you||
1571|023|W|may be pregnant, tell your doctor right away.||
1571|024|B|||
1571|025|U|USES:  Macitentan is used to treat high blood pressure in the||
1571|026|U|lungs (pulmonary arterial hypertension). This condition is||
1571|027|U|thought to be caused by increased levels of a certain natural||
1571|028|U|substance (endothelin-1). This medication blocks the effects of||
1571|029|U|endothelin-1, which helps decrease the blood pressure in the||
1571|030|U|lungs, and reduces the risk of worsening of symptoms and hospital||
1571|031|U|stays due to the disease.||
1571|032|B|||
1571|033|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1571|034|H|Patient Information Leaflet provided by your pharmacist before||
1571|035|H|you start taking macitentan and each time you get a refill. If||
1571|036|H|you have any questions, ask your doctor or pharmacist.||
1571|037|H|   Take this medication by mouth with or without food as directed||
1571|038|H|by your doctor, usually once daily. Swallow the tablet whole. Do||
1571|039|H|not split, crush, or chew the tablet.||
1571|040|H|   Use this medication regularly to get the most benefit from it.||
1571|041|H|To help you remember, take it at the same time each day.||
1571|042|H|   Do not increase your dose or use this drug more often or for||
1571|043|H|longer than prescribed. Your condition will not improve any||
1571|044|H|faster, and your risk of side effects will increase.||
1571|045|H|   Since this drug can be absorbed through the skin and lungs and||
1571|046|H|may harm an unborn baby, women who are pregnant or who may become||
1571|047|H|pregnant should not handle this medication or breathe the dust||
1571|048|H|from the tablets.||
1571|049|H|   Tell your doctor if your condition does not get better or if||
1571|050|H|it gets worse.||
1571|051|B|||
1571|052|S|SIDE EFFECTS:  Runny nose, sore throat, cough, headache, chills,||
1571|053|S|or body aches may occur. If any of these effects last or get||
1571|054|S|worse, tell your doctor or pharmacist promptly.||
1571|055|S|   Remember that this medication has been prescribed because your||
1571|056|S|doctor has judged that the benefit to you is greater than the||
1571|057|S|risk of side effects. Many people using this medication do not||
1571|058|S|have serious side effects.||
1571|059|S|   Tell your doctor right away if you have any serious side||
1571|060|S|effects, including: signs of low red blood cell count (such as||
1571|061|S|unusual tiredness, rapid breathing, pale skin, shortness of||
1571|062|S|breath, fast heartbeat), unusual weight gain, new or worsening||
1571|063|S|swelling of the hands/ankles/feet.||
1571|064|S|   Macitentan may rarely cause serious liver disease. Tell your||
1571|065|S|doctor right away if you have any symptoms of liver disease,||
1571|066|S|including: nausea/vomiting that doesn't stop, loss of appetite,||
1571|067|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
1571|068|S|   A very serious allergic reaction to this drug is rare.||
1571|069|S|However, get medical help right away if you notice any symptoms||
1571|070|S|of a serious allergic reaction, including: rash, itching/swelling||
1571|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1571|072|S|breathing.||
1571|073|S|   This is not a complete list of possible side effects. If you||
1571|074|S|notice other effects not listed above, contact your doctor or||
1571|075|S|pharmacist.||
1571|076|S|   In the US -||
1571|077|S|   Call your doctor for medical advice about side effects. You||
1571|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1571|079|S|www.fda.gov/medwatch.||
1571|080|S|   In Canada - Call your doctor for medical advice about side||
1571|081|S|effects. You may report side effects to Health Canada at||
1571|082|S|1-866-234-2345.||
1571|083|B|||
1571|084|P|PRECAUTIONS:  Before taking macitentan, tell your doctor or||
1571|085|P|pharmacist if you are allergic to it; or if you have any other||
1571|086|P|allergies. This product may contain inactive ingredients, which||
1571|087|P|can cause allergic reactions or other problems. Talk to your||
1571|088|P|pharmacist for more details.||
1571|089|P|   Before using this medication, tell your doctor or pharmacist||
1571|090|P|your medical history, especially of: anemia, liver disease, other||
1571|091|P|lung conditions (such as pulmonary veno-occlusive disease).||
1571|092|P|   Before having surgery, tell your doctor or dentist about all||
1571|093|P|the products you use (including prescription drugs,||
1571|094|P|nonprescription drugs, and herbal products).||
1571|095|P|   This medication can affect fertility in males. Ask your doctor||
1571|096|P|for more details.||
1571|097|P|   Since this drug can be absorbed through the skin and lungs and||
1571|098|P|may harm an unborn baby, women who are pregnant or who may become||
1571|099|P|pregnant should not handle this medication or breathe the dust||
1571|100|P|from the tablets.||
1571|101|P|   This medication must not be used during pregnancy. It may harm||
1571|102|P|an unborn baby. Discuss the use of reliable forms of birth||
1571|103|P|control (such as condoms, birth control pills) before starting||
1571|104|P|treatment, during treatment, and for 1 month after the last dose.||
1571|105|P|If you become pregnant or think you may be pregnant, tell your||
1571|106|P|doctor right away. See also Warning section.||
1571|107|P|   It is unknown if this medication passes into breast milk.||
1571|108|P|Because of the possible risk to the infant, breastfeeding is not||
1571|109|P|recommended while using this medication. Consult your doctor||
1571|110|P|before breastfeeding.||
1571|111|B|||
1571|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1571|113|I|medications work or increase your risk for serious side effects.||
1571|114|I|This document does not contain all possible drug interactions.||
1571|115|I|Keep a list of all the products you use (including||
1571|116|I|prescription/nonprescription drugs and herbal products) and share||
1571|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
1571|118|I|the dosage of any medicines without your doctor's approval.||
1571|119|I|   A product that may interact with this drug is: sparsentan.||
1571|120|I|   Other medications can affect the removal of macitentan from||
1571|121|I|your body, which may affect how macitentan works. Examples||
1571|122|I|include amiodarone, azole antifungals (such as fluconazole,||
1571|123|I|ketoconazole), cobicistat, macrolide antibiotics (such as||
1571|124|I|clarithromycin), rifamycins (such as rifampin), ritonavir, among||
1571|125|I|others.||
1571|126|B|||
1571|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1571|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1571|129|O|poison control center right away. US residents can call||
1571|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1571|131|B|||
1571|132|N|NOTES:  Do not share this medication with others.||
1571|133|N|   Lab tests (such as liver function, hemoglobin) should be done||
1571|134|N|before you start taking this medication and while you are taking||
1571|135|N|it. Keep all medical and lab appointments. Consult your doctor||
1571|136|N|for more details.||
1571|137|B|||
1571|138|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1571|139|D|remember. If it is near the time of the next dose, skip the||
1571|140|D|missed dose. Take your next dose at the regular time. Do not||
1571|141|D|double the dose to catch up.||
1571|142|B|||
1571|143|R|STORAGE:  Store at room temperature away from light and moisture.||
1571|144|R|Do not store in the bathroom. Keep all medications away from||
1571|145|R|children and pets.||
1571|146|R|   Do not flush medications down the toilet or pour them into a||
1571|147|R|drain unless instructed to do so. Properly discard this product||
1571|148|R|when it is expired or no longer needed. Consult your pharmacist||
1571|149|R|or local waste disposal company.||
1571|150|B|||
1571|151|A|Information last revised November 2025.||
1571|152|A|Copyright(c) 2025 First Databank, Inc.||
1571|153|B|||
1572|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1572|002|Z|does NOT have all possible information about this product. This||
1572|003|Z|information does not assure that this product is safe, effective,||
1572|004|Z|or appropriate for you. This information is not individual||
1572|005|Z|medical advice and does not substitute for the advice of your||
1572|006|Z|health care professional. Always ask your health care||
1572|007|Z|professional for complete information about this product and your||
1572|008|Z|specific health needs.||
1572|009|B|||
1572|010|T|TOCILIZUMAB - SUBCUTANEOUS INJECTION||
1572|011|F|(TOE-si-LIZ-ue-mab)||
1572|012|B|||
1572|013|C|COMMON BRAND NAME(S): Actemra, Tyenne||
1572|014|B|||
1572|015|W|WARNING:  This medication may lower your ability to fight an||
1572|016|W|infection. This may make you more likely to get a serious (rarely||
1572|017|W|fatal) infection or make any infection you have worse. Your risk||
1572|018|W|may be increased if you are also taking other drugs that can||
1572|019|W|lower your ability to fight an infection (such as methotrexate or||
1572|020|W|corticosteroids). Before using tocilizumab, tell your doctor your||
1572|021|W|medical history, especially of any kind of infection. During||
1572|022|W|treatment, get medical help right away if you have any signs of||
1572|023|W|infection (such as sore throat that doesn't go away, fever,||
1572|024|W|swollen lymph nodes, chills, painful urination).||
1572|025|W|   Before and during treatment with this medication, your doctor||
1572|026|W|will test you for tuberculosis (TB). Your doctor should also||
1572|027|W|monitor you for symptoms of TB during and after treatment with||
1572|028|W|this drug. If needed, treatment for tuberculosis or other||
1572|029|W|infections should be given before receiving this medication.||
1572|030|B|||
1572|031|U|USES:  This medication is used to treat rheumatoid arthritis in||
1572|032|U|adults and in children (such as polyarticular juvenile idiopathic||
1572|033|U|arthritis-PJIA, systemic juvenile idiopathic arthritis-SJIA). It||
1572|034|U|helps to reduce pain and swelling due to rheumatoid arthritis.||
1572|035|U|Tocilizumab is used to treat giant cell arteritis. It helps to||
1572|036|U|reduce swelling in your blood vessels so blood can flow more||
1572|037|U|easily. This medication is also used to slow down the decrease in||
1572|038|U|lung function in people with a certain type of lung disease||
1572|039|U|(systemic sclerosis-associated interstitial lung disease -||
1572|040|U|SSc-ILD). Tocilizumab belongs to a class of drugs known as||
1572|041|U|Interleukin-6 (IL-6) blockers. It works by blocking IL-6, a||
1572|042|U|substance made by the body that causes swelling (inflammation).||
1572|043|U|   This monograph is about the following tocilizumab products:||
1572|044|U|tocilizumab and tocilizumab-aazg.||
1572|045|B|||
1572|046|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1572|047|H|provided by your pharmacist before you start using tocilizumab||
1572|048|H|and each time you get a refill. Ask your health care professional||
1572|049|H|how to prepare and use this medication. If you have any||
1572|050|H|questions, ask your doctor or pharmacist.||
1572|051|H|   Inject this medication under the skin as directed by your||
1572|052|H|doctor. The injection is given in the upper arms, thighs, or||
1572|053|H|abdomen. The dosage is based on your medical condition, weight,||
1572|054|H|labs, and response to treatment.||
1572|055|H|   Depending on your product, take the medication out of the||
1572|056|H|refrigerator at least 30 or 45 minutes before you inject it to||
1572|057|H|allow it to reach room temperature. Do not warm up this||
1572|058|H|medication any other way (for example, do not heat it in the||
1572|059|H|microwave, place it in hot water, or leave it in direct||
1572|060|H|sunlight). Check this product for particles or discoloration. If||
1572|061|H|either is present, do not use the liquid. Before injecting each||
1572|062|H|dose, clean the skin you are going to inject into (the injection||
1572|063|H|site) with rubbing alcohol. Change the injection site each time||
1572|064|H|to lessen injury under the skin. Do not inject into skin that is||
1572|065|H|tender, red, hard, or broken, or into moles, scars, or bruises.||
1572|066|H|To lessen bruising, do not rub the injection site after a shot.||
1572|067|H|Learn how to store and discard medical supplies safely.||
1572|068|H|   Use this medication regularly to get the most benefit from it.||
1572|069|H|To help you remember, mark your calendar with a reminder.||
1572|070|H|   Tell your doctor if your condition does not get better or if||
1572|071|H|it gets worse.||
1572|072|B|||
1572|073|S|SIDE EFFECTS:  See also Warning section.||
1572|074|S|   Headache or irritation/redness/pain at the injection site may||
1572|075|S|occur. If any of these effects last or get worse, tell your||
1572|076|S|doctor or pharmacist promptly.||
1572|077|S|   Remember that this medication has been prescribed because your||
1572|078|S|doctor has judged that the benefit to you is greater than the||
1572|079|S|risk of side effects. Many people using this medication do not||
1572|080|S|have serious side effects.||
1572|081|S|   Tell your doctor right away if you have any serious side||
1572|082|S|effects, including: signs of stomach/intestinal problems (such as||
1572|083|S|severe stomach/abdominal pain that doesn't go away, changes in||
1572|084|S|bowel movements).||
1572|085|S|   Tocilizumab has rarely caused very serious (possibly fatal)||
1572|086|S|liver disease. This effect may occur months to years after||
1572|087|S|starting this medication. Tell your doctor right away if you||
1572|088|S|develop symptoms of liver disease, such as nausea/vomiting that||
1572|089|S|doesn't stop, loss of appetite, yellowing eyes/skin, dark urine.||
1572|090|S|   A very serious allergic reaction to this drug is rare.||
1572|091|S|However, get medical help right away if you notice any symptoms||
1572|092|S|of a serious allergic reaction, including: rash, itching/swelling||
1572|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1572|094|S|breathing.||
1572|095|S|   This is not a complete list of possible side effects. If you||
1572|096|S|notice other effects not listed above, contact your doctor or||
1572|097|S|pharmacist.||
1572|098|S|   In the US -||
1572|099|S|   Call your doctor for medical advice about side effects. You||
1572|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1572|101|S|www.fda.gov/medwatch.||
1572|102|S|   In Canada - Call your doctor for medical advice about side||
1572|103|S|effects. You may report side effects to Health Canada at||
1572|104|S|1-866-234-2345.||
1572|105|B|||
1572|106|P|PRECAUTIONS:  Before using tocilizumab, tell your doctor or||
1572|107|P|pharmacist if you are allergic to it; or to any tocilizumab||
1572|108|P|products; or if you have any other allergies. This product may||
1572|109|P|contain inactive ingredients, which can cause allergic reactions||
1572|110|P|or other problems. Talk to your pharmacist for more details.||
1572|111|P|   Before using this medication, tell your doctor or pharmacist||
1572|112|P|your medical history, especially of: diabetes, infections||
1572|113|P|(including past/current/returning), liver problems, low blood||
1572|114|P|cell count, nervous system problems (such as multiple sclerosis),||
1572|115|P|stomach/abdominal problems (such as ulcers, diverticulitis).||
1572|116|P|   Tocilizumab can make you more likely to get infections or may||
1572|117|P|make current infections worse. Stay away from anyone who has an||
1572|118|P|infection that may easily spread (such as chickenpox, COVID-19,||
1572|119|P|measles, tuberculosis, flu). Tell your doctor if you live in,||
1572|120|P|have lived in, or have traveled to certain areas where there is||
1572|121|P|an increased chance of getting certain kinds of fungal infections||
1572|122|P|(blastomycosis, coccidioidomycosis, histoplasmosis). Talk to your||
1572|123|P|doctor if you have been exposed to an infection or for more||
1572|124|P|details.||
1572|125|P|   Tell your health care professional that you are using||
1572|126|P|tocilizumab before having any immunizations/vaccinations. Avoid||
1572|127|P|contact with people who have recently received live vaccines||
1572|128|P|(such as flu vaccine inhaled through the nose).||
1572|129|P|   Drugs that affect the immune system (such as tocilizumab) may||
1572|130|P|increase your risk of certain cancers. Tell your doctor if you||
1572|131|P|have ever had any type of cancer.||
1572|132|P|   Before having surgery, tell your doctor or dentist about all||
1572|133|P|the products you use (including prescription drugs,||
1572|134|P|nonprescription drugs, and herbal products).||
1572|135|P|   During pregnancy, this medication should be used only when||
1572|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
1572|137|P|   It is unknown if this drug passes into breast milk. Consult||
1572|138|P|your doctor before breastfeeding.||
1572|139|B|||
1572|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1572|141|I|medications work or increase your risk for serious side effects.||
1572|142|I|This document does not contain all possible drug interactions.||
1572|143|I|Keep a list of all the products you use (including||
1572|144|I|prescription/nonprescription drugs and herbal products) and share||
1572|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
1572|146|I|the dosage of any medicines without your doctor's approval.||
1572|147|I|   Some products that may interact with this drug include: other||
1572|148|I|drugs that can affect the immune system (such as certolizumab,||
1572|149|I|corticosteroids including prednisone).||
1572|150|I|   This medication can speed up the removal of other medications||
1572|151|I|from your body, which may affect how they work. Examples of||
1572|152|I|affected drugs include omeprazole, warfarin, and some cholesterol||
1572|153|I|drugs such as atorvastatin/lovastatin/simvastatin, among others.||
1572|154|I|   This medication may decrease the effectiveness of hormonal||
1572|155|I|birth control such as pills, patch, or ring. This could cause||
1572|156|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1572|157|I|use reliable backup birth control methods while using this||
1572|158|I|medication. Also tell your doctor if you have any new spotting or||
1572|159|I|breakthrough bleeding, because these may be signs that your birth||
1572|160|I|control is not working well.||
1572|161|B|||
1572|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1572|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1572|164|O|poison control center right away. US residents can call||
1572|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1572|166|B|||
1572|167|N|NOTES:  Do not share this medication with others.||
1572|168|N|   Lab and/or medical tests (such as complete blood counts, liver||
1572|169|N|function, cholesterol tests) should be done before you start||
1572|170|N|using this medication and while you are using it. Keep all||
1572|171|N|medical and lab appointments. Consult your doctor for more||
1572|172|N|details.||
1572|173|B|||
1572|174|D|MISSED DOSE:  It is important to get each dose of this medication||
1572|175|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1572|176|D|right away for a new dosing schedule.||
1572|177|B|||
1572|178|R|STORAGE:  Store in the refrigerator. Do not freeze. Do not use||
1572|179|R|this medication if it has been frozen. Keep the medication in the||
1572|180|R|original carton to protect from light. This medication may also||
1572|181|R|be stored at room temperature if needed. If the medication is||
1572|182|R|stored at room temperature, do not put it back in the||
1572|183|R|refrigerator and discard after 14 days. Keep all medications away||
1572|184|R|from children and pets.||
1572|185|R|   Do not flush medications down the toilet or pour them into a||
1572|186|R|drain unless instructed to do so. Properly discard this product||
1572|187|R|when it is expired or no longer needed. Consult your pharmacist||
1572|188|R|or local waste disposal company.||
1572|189|B|||
1572|190|A|Information last revised April 2025.||
1572|191|A|Copyright(c) 2025 First Databank, Inc.||
1572|192|B|||
1573|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1573|002|Z|does NOT have all possible information about this product. This||
1573|003|Z|information does not assure that this product is safe, effective,||
1573|004|Z|or appropriate for you. This information is not individual||
1573|005|Z|medical advice and does not substitute for the advice of your||
1573|006|Z|health care professional. Always ask your health care||
1573|007|Z|professional for complete information about this product and your||
1573|008|Z|specific health needs.||
1573|009|B|||
1573|010|T|OBINUTUZUMAB - INJECTION||
1573|011|F|(OH-bi-nue-TOOZ-ue-mab)||
1573|012|B|||
1573|013|C|COMMON BRAND NAME(S): Gazyva||
1573|014|B|||
1573|015|W|WARNING:  Obinutuzumab may cause serious (possibly fatal) liver||
1573|016|W|disease in people who have a current or past infection with||
1573|017|W|hepatitis B. Before starting treatment with this medication, your||
1573|018|W|doctor should order a test to see if you have hepatitis B. Your||
1573|019|W|doctor may also order blood tests and watch for symptoms of liver||
1573|020|W|disease during treatment and for several months after your last||
1573|021|W|dose of medication. Get medical help right away if you have any||
1573|022|W|symptoms of liver damage, including: nausea/vomiting that doesn't||
1573|023|W|stop, loss of appetite, dark urine, stomach/abdominal pain,||
1573|024|W|yellowing eyes/skin.||
1573|025|W|   Obinutuzumab may increase your risk of getting a rare but very||
1573|026|W|serious (sometimes fatal) brain infection (progressive multifocal||
1573|027|W|leukoencephalopathy-PML). Get medical help right away if any of||
1573|028|W|these rare but very serious side effects occur: confusion,||
1573|029|W|dizziness, loss of balance, difficulty talking/walking, vision||
1573|030|W|changes.||
1573|031|B|||
1573|032|U|USES:  Obinutuzumab is used to treat certain types of blood||
1573|033|U|cancer (such as chronic lymphocytic leukemia, follicular||
1573|034|U|lymphoma). This medication is also used to treat a certain kidney||
1573|035|U|disorder (lupus nephritis). Lupus nephritis is an immune disorder||
1573|036|U|where certain proteins in your own body attack and cause damage||
1573|037|U|to the kidneys.||
1573|038|U|   Obinutuzumab belongs to a class of drugs known as monoclonal||
1573|039|U|antibodies. It works by stopping the growth of cancer cells. In||
1573|040|U|lupus nephritis, obinutuzumab works by decreasing damage to the||
1573|041|U|kidneys.||
1573|042|B|||
1573|043|H|HOW TO USE:  This medication is given by injection into a vein by||
1573|044|H|a health care professional. It is given as directed by your||
1573|045|H|doctor. The dosage and treatment schedule are based on your||
1573|046|H|medical condition and response to treatment.||
1573|047|H|   Infusion reactions may happen during the infusion of this drug||
1573|048|H|and for up to 24 hours afterward. Your doctor may prescribe other||
1573|049|H|medications (including acetaminophen, an antihistamine such as||
1573|050|H|diphenhydramine, a corticosteroid such as methylprednisolone)||
1573|051|H|before each treatment to help prevent these side effects. Tell||
1573|052|H|your doctor right away if you have any symptoms of infusion||
1573|053|H|reactions such as dizziness, fainting, fast heartbeat, chest||
1573|054|H|pain, wheezing, nausea, vomiting, diarrhea, flushing, headache,||
1573|055|H|fever, or chills. Your doctor may slow down or stop your||
1573|056|H|treatment for some time.||
1573|057|H|   If you take drugs for high blood pressure, ask your doctor||
1573|058|H|ahead of time if you should change the way you take your blood||
1573|059|H|pressure medication right before and after your dose of||
1573|060|H|obinutuzumab. Some people have had reactions (such as||
1573|061|H|dizziness/fainting) due to taking blood pressure medication too||
1573|062|H|close to the time of their obinutuzumab infusion.||
1573|063|B|||
1573|064|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1573|065|S|   Cough or joint/muscle pain may occur. If any of these effects||
1573|066|S|last or get worse, tell your doctor or pharmacist promptly.||
1573|067|S|   People using this medication may have serious side effects.||
1573|068|S|However, you have been prescribed this drug because your doctor||
1573|069|S|has judged that the benefit to you is greater than the risk of||
1573|070|S|side effects. Careful monitoring by your doctor may decrease your||
1573|071|S|risk.||
1573|072|S|   This medication decreases bone marrow function, an effect that||
1573|073|S|may lead to a low number of blood cells such as red cells, white||
1573|074|S|cells, and platelets. This effect can cause anemia, decrease your||
1573|075|S|body's ability to fight an infection, or cause easy||
1573|076|S|bruising/bleeding. Tell your doctor right away if you develop any||
1573|077|S|of the following symptoms: unusual tiredness, pale skin, signs of||
1573|078|S|infection (such as sore throat that doesn't go away, fever,||
1573|079|S|chills), easy bruising/bleeding.||
1573|080|S|   Obinutuzumab sometimes causes side effects due to the rapid||
1573|081|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1573|082|S|risk, your doctor may add a medication and tell you to drink||
1573|083|S|plenty of fluids. Tell your doctor right away if you have||
1573|084|S|symptoms such as: low back/side pain (flank pain), signs of||
1573|085|S|kidney problems (such as painful urination, pink/bloody urine,||
1573|086|S|change in the amount of urine), muscle spasms/weakness.||
1573|087|S|   Get medical help right away if you have any very serious side||
1573|088|S|effects, including: chest pain, pain/swelling/warmth in the||
1573|089|S|groin/calf.||
1573|090|S|   A very serious allergic reaction to this drug is rare.||
1573|091|S|However, get medical help right away if you notice any symptoms||
1573|092|S|of a serious allergic reaction, including: rash, itching/swelling||
1573|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1573|094|S|breathing.||
1573|095|S|   This is not a complete list of possible side effects. If you||
1573|096|S|notice other effects not listed above, contact your doctor or||
1573|097|S|pharmacist.||
1573|098|S|   In the US -||
1573|099|S|   Call your doctor for medical advice about side effects. You||
1573|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1573|101|S|www.fda.gov/medwatch.||
1573|102|S|   In Canada - Call your doctor for medical advice about side||
1573|103|S|effects. You may report side effects to Health Canada at||
1573|104|S|1-866-234-2345.||
1573|105|B|||
1573|106|P|PRECAUTIONS:  Before using obinutuzumab, tell your doctor or||
1573|107|P|pharmacist if you are allergic to it; or if you have any other||
1573|108|P|allergies. This product may contain inactive ingredients, which||
1573|109|P|can cause allergic reactions or other problems. Talk to your||
1573|110|P|pharmacist for more details.||
1573|111|P|   Before using this medication, tell your doctor or pharmacist||
1573|112|P|your medical history, especially of: liver disease (such as||
1573|113|P|hepatitis B), active/current infection, heart disease, kidney||
1573|114|P|disease, lung disease.||
1573|115|P|   Obinutuzumab can make you more likely to get infections or may||
1573|116|P|make current infections worse. Stay away from anyone who has an||
1573|117|P|infection that may easily spread (such as chickenpox, COVID-19,||
1573|118|P|measles, flu). Talk to your doctor if you have been exposed to an||
1573|119|P|infection or for more details.||
1573|120|P|   Tell your health care professional that you are using||
1573|121|P|obinutuzumab before having any immunizations/vaccinations. Avoid||
1573|122|P|contact with people who have recently received live vaccines||
1573|123|P|(such as flu vaccine inhaled through the nose).||
1573|124|P|   To lower the chance of getting cut, bruised, or injured, use||
1573|125|P|caution with sharp objects like razors and nail cutters, and||
1573|126|P|avoid activities such as contact sports.||
1573|127|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1573|128|P|can make you more dizzy. Do not drive, use machinery, or do||
1573|129|P|anything that needs alertness until you can do it safely. Limit||
1573|130|P|alcoholic beverages. Talk to your doctor if you are using||
1573|131|P|marijuana (cannabis).||
1573|132|P|   Before having surgery, tell your doctor or dentist about all||
1573|133|P|the products you use (including prescription drugs,||
1573|134|P|nonprescription drugs, and herbal products).||
1573|135|P|   Tell your doctor if you are pregnant or plan to become||
1573|136|P|pregnant. You should not become pregnant while using||
1573|137|P|obinutuzumab. Obinutuzumab may harm an unborn baby. Ask about||
1573|138|P|reliable forms of birth control while using this medication and||
1573|139|P|for 6 months after the last dose. If you become pregnant, talk to||
1573|140|P|your doctor right away about the risks and benefits of this||
1573|141|P|medication.||
1573|142|P|   This medication may pass into breast milk. Because of the||
1573|143|P|possible risk to the infant, breastfeeding is not recommended||
1573|144|P|while using this medication and for 6 months after the last dose.||
1573|145|P|Consult your doctor before breastfeeding.||
1573|146|B|||
1573|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1573|148|I|medications work or increase your risk for serious side effects.||
1573|149|I|This document does not contain all possible drug interactions.||
1573|150|I|Keep a list of all the products you use (including||
1573|151|I|prescription/nonprescription drugs and herbal products) and share||
1573|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
1573|153|I|the dosage of any medicines without your doctor's approval.||
1573|154|I|   Some products that may interact with this drug include: other||
1573|155|I|drugs that weaken the immune system/increase the risk of||
1573|156|I|infection (such as natalizumab, rituximab).||
1573|157|B|||
1573|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1573|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1573|160|O|poison control center right away. US residents can call||
1573|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1573|162|B|||
1573|163|N|NOTES:  Do not share this medication with others.||
1573|164|N|   Lab tests (such as kidney function, complete blood count)||
1573|165|N|should be done while you are using this medication. Keep all||
1573|166|N|medical and lab appointments. Consult your doctor for more||
1573|167|N|details.||
1573|168|B|||
1573|169|D|MISSED DOSE:  It is important to get each dose of this medication||
1573|170|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1573|171|D|right away for a new dosing schedule.||
1573|172|B|||
1573|173|R|STORAGE:  Not applicable. This medication is given in a hospital||
1573|174|R|or clinic and will not be stored at home.||
1573|175|B|||
1573|176|M|MEDICAL ALERT:  Your condition can cause complications in a||
1573|177|M|medical emergency. For information about enrolling in MedicAlert,||
1573|178|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1573|179|B|||
1573|180|A|Information last revised October 2025.||
1573|181|A|Copyright(c) 2025 First Databank, Inc.||
1573|182|B|||
1575|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1575|002|Z|does NOT have all possible information about this product. This||
1575|003|Z|information does not assure that this product is safe, effective,||
1575|004|Z|or appropriate for you. This information is not individual||
1575|005|Z|medical advice and does not substitute for the advice of your||
1575|006|Z|health care professional. Always ask your health care||
1575|007|Z|professional for complete information about this product and your||
1575|008|Z|specific health needs.||
1575|009|B|||
1575|010|T|NATAMYCIN - OPHTHALMIC||
1575|011|F|(NA-ta-MYE-sin)||
1575|012|B|||
1575|013|C|COMMON BRAND NAME(S): Natacyn||
1575|014|B|||
1575|015|U|USES:  Natamycin is used to treat fungal eye infections. It works||
1575|016|U|by stopping the growth of certain types of fungus.||
1575|017|U|   This medication treats only fungal eye infections. It will not||
1575|018|U|work for other types of eye infections. Unnecessary use or misuse||
1575|019|U|of any drug used to treat infection can lead to its decreased||
1575|020|U|effectiveness.||
1575|021|B|||
1575|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1575|023|H|directed by your doctor.||
1575|024|H|   To apply eye drops, wash hands first. To avoid contamination,||
1575|025|H|do not touch the dropper tip or let it touch your eye or any||
1575|026|H|other surface.||
1575|027|H|   Do not wear contact lenses while you are using this||
1575|028|H|medication. Sterilize contact lenses according to the||
1575|029|H|manufacturer's directions, and check with your doctor before you||
1575|030|H|begin using them again.||
1575|031|H|   Shake the bottle well before using. Tilt your head back, look||
1575|032|H|upward, and pull down the lower eyelid to make a pouch. Hold the||
1575|033|H|dropper directly over your eye and place one drop into the pouch.||
1575|034|H|Look downward, gently close your eyes, and place one finger at||
1575|035|H|the corner of your eye (near the nose). Apply gentle pressure for||
1575|036|H|1 to 2 minutes before opening your eyes. This will prevent the||
1575|037|H|medication from draining out. Try not to blink or rub your eye.||
1575|038|H|If directed to use this medication in both eyes, repeat these||
1575|039|H|steps for your other eye. Do not rinse the dropper. Replace the||
1575|040|H|dropper cap after each use.||
1575|041|H|   If you are using another kind of eye medication (such as drops||
1575|042|H|or ointments), wait at least 5 minutes before applying other||
1575|043|H|medications. Use eye drops before eye ointments to allow the||
1575|044|H|drops to enter the eye.||
1575|045|H|   Wait several minutes for your vision to clear before driving||
1575|046|H|or operating machinery.||
1575|047|H|   Use this medication regularly to get the most benefit from it.||
1575|048|H|Continue to use it for the full time prescribed, even if symptoms||
1575|049|H|disappear after a few days. Stopping the medication too early may||
1575|050|H|result in a return of the infection.||
1575|051|H|   This medication is usually prescribed for 2 to 3 weeks or||
1575|052|H|until the infection is cured. Tell your doctor if your condition||
1575|053|H|lasts or gets worse.||
1575|054|B|||
1575|055|S|SIDE EFFECTS:  Eye discomfort or irritation may occur. If either||
1575|056|S|of these effects lasts or gets worse, tell your doctor or||
1575|057|S|pharmacist promptly.||
1575|058|S|   Remember that this medication has been prescribed because your||
1575|059|S|doctor has judged that the benefit to you is greater than the||
1575|060|S|risk of side effects. Many people using this medication do not||
1575|061|S|have serious side effects.||
1575|062|S|   A very serious allergic reaction to this drug is rare.||
1575|063|S|However, get medical help right away if you notice any symptoms||
1575|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1575|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1575|066|S|breathing.||
1575|067|S|   This is not a complete list of possible side effects. If you||
1575|068|S|notice other effects not listed above, contact your doctor or||
1575|069|S|pharmacist.||
1575|070|S|   In the US -||
1575|071|S|   Call your doctor for medical advice about side effects. You||
1575|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1575|073|S|www.fda.gov/medwatch.||
1575|074|S|   In Canada - Call your doctor for medical advice about side||
1575|075|S|effects. You may report side effects to Health Canada at||
1575|076|S|1-866-234-2345.||
1575|077|B|||
1575|078|P|PRECAUTIONS:  Before using natamycin, tell your doctor or||
1575|079|P|pharmacist if you are allergic to it; or if you have any other||
1575|080|P|allergies. This product may contain inactive ingredients, which||
1575|081|P|can cause allergic reactions or other problems. Talk to your||
1575|082|P|pharmacist for more details.||
1575|083|P|   Before using this medication, tell your doctor or pharmacist||
1575|084|P|your medical history.||
1575|085|P|   After you apply this drug, your vision may become temporarily||
1575|086|P|blurred. Do not drive, use machinery, or do anything that needs||
1575|087|P|clear vision until you can do it safely.||
1575|088|P|   During pregnancy, this medication should be used only when||
1575|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
1575|090|P|   It is unknown if this drug passes into breast milk. Consult||
1575|091|P|your doctor before breastfeeding.||
1575|092|B|||
1575|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1575|094|I|medications work or increase your risk for serious side effects.||
1575|095|I|This document does not contain all possible drug interactions.||
1575|096|I|Keep a list of all the products you use (including||
1575|097|I|prescription/nonprescription drugs and herbal products) and share||
1575|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
1575|099|I|the dosage of any medicines without your doctor's approval.||
1575|100|I|   Some products that may interact with this drug include:||
1575|101|I|corticosteroid eye medications (such as dexamethasone,||
1575|102|I|prednisolone).||
1575|103|B|||
1575|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1575|105|O|has overdosed and has serious symptoms such as passing out or||
1575|106|O|trouble breathing, call 911. Otherwise, call a poison control||
1575|107|O|center right away. US residents can call 1-800-222-1222. Canada||
1575|108|O|residents can call 1-844-764-7669.||
1575|109|B|||
1575|110|N|NOTES:  Do not share this medication with others.||
1575|111|N|   This medication has been prescribed for your current condition||
1575|112|N|only. Throw away the unused medication after treatment is||
1575|113|N|completed. Do not use it later for another infection unless your||
1575|114|N|doctor tells you to.||
1575|115|B|||
1575|116|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1575|117|D|If it is near the time of the next dose, skip the missed dose.||
1575|118|D|Use your next dose at the regular time. Do not double the dose to||
1575|119|D|catch up.||
1575|120|B|||
1575|121|R|STORAGE:  Store at room temperature or in the refrigerator away||
1575|122|R|from light and heat. Do not freeze. Keep all medications away||
1575|123|R|from children and pets.||
1575|124|R|   Do not flush medications down the toilet or pour them into a||
1575|125|R|drain unless instructed to do so. Properly discard this product||
1575|126|R|when it is expired or no longer needed. Consult your pharmacist||
1575|127|R|or local waste disposal company.||
1575|128|B|||
1575|129|A|Information last revised September 2024.||
1575|130|A|Copyright(c) 2025 First Databank, Inc.||
1575|131|B|||
1576|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1576|002|Z|does NOT have all possible information about this product. This||
1576|003|Z|information does not assure that this product is safe, effective,||
1576|004|Z|or appropriate for you. This information is not individual||
1576|005|Z|medical advice and does not substitute for the advice of your||
1576|006|Z|health care professional. Always ask your health care||
1576|007|Z|professional for complete information about this product and your||
1576|008|Z|specific health needs.||
1576|009|B|||
1576|010|T|IBRUTINIB - ORAL||
1576|011|F|(eye-BROO-ti-nib)||
1576|012|B|||
1576|013|C|COMMON BRAND NAME(S): Imbruvica||
1576|014|B|||
1576|015|U|USES:  This medication is used to treat certain cancers (such as||
1576|016|U|chronic lymphocytic leukemia/small lymphocytic lymphoma,||
1576|017|U|Waldenstrom's macroglobulinemia). Ibrutinib belongs to a class of||
1576|018|U|drugs known as kinase inhibitors. It works by slowing or stopping||
1576|019|U|the growth of cancer cells.||
1576|020|U|   Ibrutinib is also used to treat a certain problem that may||
1576|021|U|occur after a stem cell transplant (chronic graft versus host||
1576|022|U|disease). It works by weakening your body's defense system||
1576|023|U|(immune system).||
1576|024|B|||
1576|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1576|026|H|from your pharmacist before you start taking ibrutinib and each||
1576|027|H|time you get a refill. If you have any questions, ask your doctor||
1576|028|H|or pharmacist.||
1576|029|H|   Take this medication by mouth with a full glass of water (8||
1576|030|H|ounces or 240 milliliters) as directed by your doctor, usually||
1576|031|H|once daily. Swallow the capsules and tablets whole. Do not open,||
1576|032|H|break, or chew the capsules. Do not cut, crush, or chew the||
1576|033|H|tablets. Drink plenty of fluids while taking ibrutinib unless||
1576|034|H|otherwise directed by your doctor.||
1576|035|H|   The dosage is based on your medical condition, response to||
1576|036|H|treatment, and other medications you may be taking. Children's||
1576|037|H|dosage is based on age and body size. Be sure to tell your doctor||
1576|038|H|and pharmacist about all the products you use (including||
1576|039|H|prescription drugs, nonprescription drugs, and herbal products).||
1576|040|H|   Do not increase your dose or take this medication more often||
1576|041|H|than prescribed. Your condition will not improve any faster, and||
1576|042|H|your risk of serious side effects will increase.||
1576|043|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1576|044|H|using this medication unless your doctor or pharmacist says you||
1576|045|H|may do so safely. Also avoid eating Seville oranges (often found||
1576|046|H|in marmalade). Grapefruit and Seville oranges can increase the||
1576|047|H|chance of side effects with this medicine. Ask your doctor or||
1576|048|H|pharmacist for more details.||
1576|049|H|   Since this drug can be absorbed through the skin and lungs and||
1576|050|H|may harm an unborn baby, women who are pregnant or who may become||
1576|051|H|pregnant should not handle this medication or breathe the dust||
1576|052|H|from the capsules.||
1576|053|B|||
1576|054|S|SIDE EFFECTS:  Upset stomach, diarrhea, nausea, vomiting,||
1576|055|S|decreased appetite, headache, joint/muscle pain,||
1576|056|S|numbness/tingling of arms/legs, constipation, dizziness, or||
1576|057|S|tiredness may occur. If any of these effects last or get worse,||
1576|058|S|tell your doctor or pharmacist promptly.||
1576|059|S|   Remember that this medication has been prescribed because your||
1576|060|S|doctor has judged that the benefit to you is greater than the||
1576|061|S|risk of side effects. Many people using this medication do not||
1576|062|S|have serious side effects.||
1576|063|S|   This medication may raise your blood pressure. Check your||
1576|064|S|blood pressure regularly and tell your doctor if the results are||
1576|065|S|high. Your doctor may control your blood pressure with||
1576|066|S|medication.||
1576|067|S|   Tell your doctor right away if you have any serious side||
1576|068|S|effects, including: easy bruising/bleeding, black/bloody stools,||
1576|069|S|vomit that looks like coffee grounds, fast/irregular/pounding||
1576|070|S|heartbeat, unusual tiredness, swelling ankles/feet, signs of low||
1576|071|S|red blood cell count (such as rapid breathing, pale skin,||
1576|072|S|shortness of breath).||
1576|073|S|   Ibrutinib sometimes causes side effects due to the rapid||
1576|074|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1576|075|S|risk, your doctor may add a medication and tell you to drink||
1576|076|S|plenty of fluids. Tell your doctor right away if you have||
1576|077|S|symptoms such as: low back/side pain (flank pain), signs of||
1576|078|S|kidney problems (such as painful urination, pink/bloody urine,||
1576|079|S|change in the amount of urine), muscle spasms/weakness.||
1576|080|S|   This medication may lower your ability to fight infections.||
1576|081|S|This may make you more likely to get a serious (rarely fatal)||
1576|082|S|infection or make any infection you have worse. Tell your doctor||
1576|083|S|right away if you have any signs of infection (such as sore||
1576|084|S|throat that doesn't go away, fever, chills).||
1576|085|S|   This medication has rarely caused very serious (possibly||
1576|086|S|fatal) liver disease. Tell your doctor right away if you develop||
1576|087|S|symptoms of liver disease, such as nausea/vomiting that doesn't||
1576|088|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
1576|089|S|eyes/skin, dark urine.||
1576|090|S|   Very rarely, people taking this medication have developed||
1576|091|S|other cancers (including skin cancer). Consult your doctor for||
1576|092|S|more details.||
1576|093|S|   Get medical help right away if you have any very serious side||
1576|094|S|effects, including: chest pain, signs of bleeding in the brain or||
1576|095|S|a stroke (such as fainting, sudden vision changes, severe nausea,||
1576|096|S|seizures, confusion, weakness on one side of the body, trouble||
1576|097|S|speaking).||
1576|098|S|   A very serious allergic reaction to this drug is rare.||
1576|099|S|However, get medical help right away if you notice any symptoms||
1576|100|S|of a serious allergic reaction, including: rash, itching/swelling||
1576|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1576|102|S|breathing.||
1576|103|S|   This is not a complete list of possible side effects. If you||
1576|104|S|notice any other effects not listed above, contact your doctor or||
1576|105|S|pharmacist.||
1576|106|S|   In the US -||
1576|107|S|   Call your doctor for medical advice about side effects. You||
1576|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1576|109|S|www.fda.gov/medwatch.||
1576|110|S|   In Canada - Call your doctor for medical advice about side||
1576|111|S|effects. You may report side effects to Health Canada at||
1576|112|S|1-866-234-2345.||
1576|113|B|||
1576|114|P|PRECAUTIONS:  Before taking ibrutinib, tell your doctor or||
1576|115|P|pharmacist if you are allergic to it; or if you have any other||
1576|116|P|allergies. This product may contain inactive ingredients, which||
1576|117|P|can cause allergic reactions or other problems. Talk to your||
1576|118|P|pharmacist for more details.||
1576|119|P|   Before using this medication, tell your doctor or pharmacist||
1576|120|P|your medical history, especially of: blood/bleeding problems,||
1576|121|P|heart problems (such as fast/irregular heartbeat, previous heart||
1576|122|P|attack), high blood pressure, kidney problems, liver problems,||
1576|123|P|high levels of uric acid in the blood.||
1576|124|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1576|125|P|can make you more dizzy. Do not drive, use machinery, or do||
1576|126|P|anything that needs alertness until you can do it safely. Limit||
1576|127|P|alcoholic beverages. Talk to your doctor if you are using||
1576|128|P|marijuana (cannabis).||
1576|129|P|   Ibrutinib can make you more likely to get infections or may||
1576|130|P|make current infections worse. Stay away from anyone who has an||
1576|131|P|infection that may easily spread (such as chickenpox, COVID-19,||
1576|132|P|measles, flu). Talk to your doctor if you have been exposed to an||
1576|133|P|infection or for more details.||
1576|134|P|   Tell your health care professional that you are using||
1576|135|P|ibrutinib before having any immunizations/vaccinations. Avoid||
1576|136|P|contact with people who have recently received live vaccines||
1576|137|P|(such as flu vaccine inhaled through the nose).||
1576|138|P|   To lower the chance of getting cut, bruised, or injured, use||
1576|139|P|caution with sharp objects like razors and nail cutters, and||
1576|140|P|avoid activities such as contact sports.||
1576|141|P|   Before having surgery, tell your doctor or dentist about all||
1576|142|P|the products you use (including prescription drugs,||
1576|143|P|nonprescription drugs, and herbal products). Your doctor may tell||
1576|144|P|you to temporarily stop treatment with this medication before||
1576|145|P|certain medical, surgical, or dental procedures.||
1576|146|P|   Older adults may be at greater risk for low red blood cell||
1576|147|P|count, bleeding, fast/irregular heartbeat, and high blood||
1576|148|P|pressure while using this drug.||
1576|149|P|   Since this drug can be absorbed through the skin and lungs and||
1576|150|P|may harm an unborn baby, women who are pregnant or who may become||
1576|151|P|pregnant should not handle this medication or breathe the dust||
1576|152|P|from the capsules.||
1576|153|P|   Tell your doctor if you are pregnant or plan to become||
1576|154|P|pregnant. You should not become pregnant while using ibrutinib.||
1576|155|P|Ibrutinib may harm an unborn baby. Your doctor should order a||
1576|156|P|pregnancy test before you start this medication. Men and women||
1576|157|P|using this medication should ask about reliable forms of birth||
1576|158|P|control during treatment and for 1 month after the last dose. If||
1576|159|P|you or your partner becomes pregnant, talk to your doctor right||
1576|160|P|away about the risks and benefits of this medication.||
1576|161|P|   It is unknown if this drug passes into breast milk. Because of||
1576|162|P|the possible risk to the infant, breastfeeding is not recommended||
1576|163|P|while using this drug and for 1 week after the last dose. Consult||
1576|164|P|your doctor before breastfeeding.||
1576|165|B|||
1576|166|I|DRUG INTERACTIONS:  See also How to Use section.||
1576|167|I|   Drug interactions may change how your medications work or||
1576|168|I|increase your risk for serious side effects. This document does||
1576|169|I|not contain all possible drug interactions. Keep a list of all||
1576|170|I|the products you use (including prescription/nonprescription||
1576|171|I|drugs and herbal products) and share it with your doctor and||
1576|172|I|pharmacist. Do not start, stop, or change the dosage of any||
1576|173|I|medicines without your doctor's approval.||
1576|174|I|   Some products that may interact with this drug are: other||
1576|175|I|drugs that can cause bleeding/bruising (such as antiplatelet||
1576|176|I|drugs like clopidogrel, NSAIDs like ibuprofen/naproxen, "blood||
1576|177|I|thinners" like warfarin/dabigatran).||
1576|178|I|   Aspirin can increase the risk of bleeding when used with this||
1576|179|I|medication. However, if your doctor has told you to take low-dose||
1576|180|I|aspirin to prevent heart attack or stroke (usually 81-162||
1576|181|I|milligrams a day), you should keep taking the aspirin unless your||
1576|182|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1576|183|I|details.||
1576|184|I|   Other medications can affect the removal of ibrutinib from||
1576|185|I|your body, which may affect how ibrutinib works. Examples include||
1576|186|I|azole antifungals (such as itraconazole, ketoconazole),||
1576|187|I|nefazodone, St. John's wort, macrolide antibiotics (such as||
1576|188|I|erythromycin, clarithromycin), rifamycins (such as rifampin,||
1576|189|I|rifabutin), ritonavir, certain drugs used to treat seizures (such||
1576|190|I|as carbamazepine, phenytoin), among others.||
1576|191|B|||
1576|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1576|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1576|194|O|poison control center right away. US residents can call||
1576|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1576|196|B|||
1576|197|N|NOTES:  Do not share this medication with others.||
1576|198|N|   Lab and/or medical tests (such as complete blood count,||
1576|199|N|kidney/liver/heart function, heart rate, uric acid) should be||
1576|200|N|done while you are taking this medication. Keep all medical and||
1576|201|N|lab appointments. Consult your doctor for more details.||
1576|202|B|||
1576|203|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1576|204|D|remember. If you don't remember until the next day, skip the||
1576|205|D|missed dose. Take your next dose at the regular time. Do not||
1576|206|D|double the dose to catch up.||
1576|207|B|||
1576|208|R|STORAGE:  Store in the original container at room temperature||
1576|209|R|away from light and moisture. Do not store in the bathroom. Keep||
1576|210|R|all medications away from children and pets.||
1576|211|R|   Do not flush medications down the toilet or pour them into a||
1576|212|R|drain unless instructed to do so. Properly discard this product||
1576|213|R|when it is expired or no longer needed. Consult your pharmacist||
1576|214|R|or local waste disposal company.||
1576|215|B|||
1576|216|M|MEDICAL ALERT:  Your condition can cause complications in a||
1576|217|M|medical emergency. For information about enrolling in MedicAlert,||
1576|218|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1576|219|B|||
1576|220|A|Information last revised April 2025.||
1576|221|A|Copyright(c) 2025 First Databank, Inc.||
1576|222|B|||
1577|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1577|002|Z|does NOT have all possible information about this product. This||
1577|003|Z|information does not assure that this product is safe, effective,||
1577|004|Z|or appropriate for you. This information is not individual||
1577|005|Z|medical advice and does not substitute for the advice of your||
1577|006|Z|health care professional. Always ask your health care||
1577|007|Z|professional for complete information about this product and your||
1577|008|Z|specific health needs.||
1577|009|B|||
1577|010|T|LEVOMILNACIPRAN - ORAL||
1577|011|F|(LEE-voe-mil-NA-si-pran)||
1577|012|B|||
1577|013|C|COMMON BRAND NAME(S): Fetzima||
1577|014|B|||
1577|015|W|WARNING:  Antidepressant medications are used to treat a variety||
1577|016|W|of conditions, including depression and other mental/mood||
1577|017|W|disorders. These medications can help prevent suicidal||
1577|018|W|thoughts/attempts and provide other important benefits. However,||
1577|019|W|studies have shown that a small number of people (especially||
1577|020|W|people younger than 25) who take antidepressants for any||
1577|021|W|condition may experience worsening depression, other mental/mood||
1577|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
1577|023|W|talk with the doctor about the risks and benefits of||
1577|024|W|antidepressant medication (especially for people younger than||
1577|025|W|25), even if treatment is not for a mental/mood condition.||
1577|026|W|   Tell the doctor right away if you notice worsening||
1577|027|W|depression/other psychiatric conditions, unusual behavior changes||
1577|028|W|(including possible suicidal thoughts/attempts), or other||
1577|029|W|mental/mood changes (including new/worsening anxiety, panic||
1577|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1577|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
1577|032|W|especially watchful for these symptoms when a new antidepressant||
1577|033|W|is started or when the dose is changed.||
1577|034|B|||
1577|035|U|USES:  This medication is used to treat depression.||
1577|036|U|Levomilnacipran belongs to a class of drugs known as||
1577|037|U|serotonin-norepinephrine reuptake inhibitors (SNRIs). It works by||
1577|038|U|helping to restore the balance of certain natural substances||
1577|039|U|(serotonin and norepinephrine) in the brain.||
1577|040|B|||
1577|041|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1577|042|H|Patient Information Leaflet provided by your pharmacist before||
1577|043|H|you start taking levomilnacipran and each time you get a refill.||
1577|044|H|If you have any questions, ask your doctor or pharmacist.||
1577|045|H|   Take this medication by mouth with or without food as directed||
1577|046|H|by your doctor, usually once daily. Swallow the capsules whole.||
1577|047|H|Do not open, crush or chew the capsules. Doing so can release all||
1577|048|H|of the drug at once, increasing the risk of side effects.||
1577|049|H|   The dosage is based on your medical condition, response to||
1577|050|H|treatment, and other medications you may be taking. Be sure to||
1577|051|H|tell your doctor and pharmacist about all the products you use||
1577|052|H|(including prescription drugs, nonprescription drugs, and herbal||
1577|053|H|products).||
1577|054|H|   To reduce your risk of side effects, your doctor may direct||
1577|055|H|you to start this medication at a low dose and gradually increase||
1577|056|H|your dose. Follow your doctor's instructions carefully.||
1577|057|H|   Use this medication regularly to get the most benefit from it.||
1577|058|H|To help you remember, take it at the same time each day.||
1577|059|H|   Do not increase your dose or use this drug more often or for||
1577|060|H|longer than prescribed. Your condition will not improve any||
1577|061|H|faster, and your risk of side effects will increase.||
1577|062|H|   It may take several months before you get the full benefit of||
1577|063|H|this drug.||
1577|064|H|   Keep taking this medication even if you feel well. Do not stop||
1577|065|H|taking this medication without consulting your doctor. Some||
1577|066|H|conditions may become worse when this drug is suddenly stopped.||
1577|067|H|Also, you may experience symptoms such as mood swings, headache,||
1577|068|H|tiredness, sleep changes, and brief feelings similar to electric||
1577|069|H|shock. To prevent these symptoms while you are stopping treatment||
1577|070|H|with this drug, your doctor may reduce your dose gradually.||
1577|071|H|Consult your doctor or pharmacist for more details. Report any||
1577|072|H|new or worsening symptoms right away.||
1577|073|H|   Tell your doctor if your condition lasts or gets worse.||
1577|074|B|||
1577|075|S|SIDE EFFECTS:  See also Warning section.||
1577|076|S|   Constipation, vomiting, increased sweating, dizziness, or nose||
1577|077|S|bleeds may occur. If any of these effects last or get worse, tell||
1577|078|S|your doctor or pharmacist promptly.||
1577|079|S|   Remember that this medication has been prescribed because your||
1577|080|S|doctor has judged that the benefit to you is greater than the||
1577|081|S|risk of side effects. Many people using this medication do not||
1577|082|S|have serious side effects.||
1577|083|S|   This medication may raise your blood pressure. Check your||
1577|084|S|blood pressure regularly and tell your doctor if the results are||
1577|085|S|high.||
1577|086|S|   Tell your doctor right away if you have any serious side||
1577|087|S|effects, including: pounding heartbeat, easy bleeding/bruising,||
1577|088|S|decreased interest in sex, changes in sexual ability, problems||
1577|089|S|beginning the flow of urine, painful/difficult urination, changes||
1577|090|S|in sexual ability, decreased interest in sex, signs of low level||
1577|091|S|of sodium in the blood (such as nausea, extreme drowsiness,||
1577|092|S|mental/mood changes).||
1577|093|S|   Get medical help right away if you have any very serious side||
1577|094|S|effects, including: black stools, vomit that looks like coffee||
1577|095|S|grounds, seizures, eye pain/swelling/redness, widened pupils,||
1577|096|S|vision changes (such as seeing rainbows around lights at night,||
1577|097|S|blurred vision).||
1577|098|S|   This medication may increase serotonin and rarely cause a very||
1577|099|S|serious condition called serotonin syndrome/toxicity. The risk||
1577|100|S|increases if you are also taking other drugs that increase||
1577|101|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1577|102|S|take (see Drug Interactions section). Get medical help right away||
1577|103|S|if you develop some of the following symptoms: fast heartbeat,||
1577|104|S|hallucinations, loss of coordination, severe dizziness, severe||
1577|105|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1577|106|S|unusual agitation/restlessness.||
1577|107|S|   A very serious allergic reaction to this drug is rare.||
1577|108|S|However, get medical help right away if you notice any symptoms||
1577|109|S|of a serious allergic reaction, including: rash, itching/swelling||
1577|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1577|111|S|breathing.||
1577|112|S|   This is not a complete list of possible side effects. If you||
1577|113|S|notice other effects not listed above, contact your doctor or||
1577|114|S|pharmacist.||
1577|115|S|   In the US -||
1577|116|S|   Call your doctor for medical advice about side effects. You||
1577|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1577|118|S|www.fda.gov/medwatch.||
1577|119|S|   In Canada - Call your doctor for medical advice about side||
1577|120|S|effects. You may report side effects to Health Canada at||
1577|121|S|1-866-234-2345.||
1577|122|B|||
1577|123|P|PRECAUTIONS:  Before taking levomilnacipran, tell your doctor or||
1577|124|P|pharmacist if you are allergic to it; or to milnacipran; or if||
1577|125|P|you have any other allergies. This product may contain inactive||
1577|126|P|ingredients, which can cause allergic reactions or other||
1577|127|P|problems. Talk to your pharmacist for more details.||
1577|128|P|   Before using this medication, tell your doctor or pharmacist||
1577|129|P|your medical history, especially of: bleeding problems, kidney||
1577|130|P|problems, personal or family history of glaucoma (angle-closure||
1577|131|P|type), personal or family history of a certain mental/mood||
1577|132|P|disorder (bipolar disorder), personal or family history of||
1577|133|P|suicide attempts, high blood pressure, heart problems (such as||
1577|134|P|chest pain, heart attack, fast/irregular heartbeat), poor blood||
1577|135|P|flow to the brain, urinary retention or problems urinating (such||
1577|136|P|as enlarged prostate), seizures, mineral imbalance (low level of||
1577|137|P|sodium in the blood).||
1577|138|P|   This drug may make you dizzy or blur your vision. Alcohol or||
1577|139|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
1577|140|P|machinery, or do anything that needs alertness or clear vision||
1577|141|P|until you can do it safely. Avoid alcoholic beverages. Talk to||
1577|142|P|your doctor if you are using marijuana (cannabis).||
1577|143|P|   Before having surgery, tell your doctor or dentist about all||
1577|144|P|the products you use (including prescription drugs,||
1577|145|P|nonprescription drugs, and herbal products).||
1577|146|P|   Older adults may be more sensitive to the side effects of this||
1577|147|P|drug, especially bleeding. Older adults may also be at greater||
1577|148|P|risk for a certain mineral imbalance (low level of sodium in the||
1577|149|P|blood) while using this drug, especially if they are taking||
1577|150|P|"water pills" (diuretics).||
1577|151|P|   During pregnancy, this medication should be used only when||
1577|152|P|clearly needed. It may harm an unborn baby. Also, babies born to||
1577|153|P|mothers who have used this drug during the last 3 months of||
1577|154|P|pregnancy may rarely develop withdrawal symptoms such as||
1577|155|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
1577|156|P|constant crying. If you notice any of these symptoms in your||
1577|157|P|newborn, tell the doctor promptly.||
1577|158|P|   Since untreated mental/mood problems (such as depression) can||
1577|159|P|be a serious condition, do not stop taking this medication unless||
1577|160|P|directed by your doctor. If you are planning pregnancy, become||
1577|161|P|pregnant, or think you may be pregnant, immediately discuss with||
1577|162|P|your doctor the benefits and risks of using this medication||
1577|163|P|during pregnancy.||
1577|164|P|   It is unknown if this medication passes into breast milk.||
1577|165|P|However, similar drugs pass into breast milk. Consult your doctor||
1577|166|P|before breastfeeding.||
1577|167|B|||
1577|168|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1577|169|I|medications work or increase your risk for serious side effects.||
1577|170|I|This document does not contain all possible drug interactions.||
1577|171|I|Keep a list of all the products you use (including||
1577|172|I|prescription/nonprescription drugs and herbal products) and share||
1577|173|I|it with your doctor and pharmacist. Do not start, stop, or change||
1577|174|I|the dosage of any medicines without your doctor's approval.||
1577|175|I|   Some products that may interact with this drug are:||
1577|176|I|diuretics/"water pills" (such as furosemide), other drugs that||
1577|177|I|can cause bleeding/bruising (including antiplatelet drugs such as||
1577|178|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
1577|179|I|such as dabigatran/warfarin).||
1577|180|I|   Aspirin can increase the risk of bleeding when used with this||
1577|181|I|medication. However, if your doctor has told you to take low-dose||
1577|182|I|aspirin to prevent heart attack or stroke (usually 81-162||
1577|183|I|milligrams a day), you should keep taking the aspirin unless your||
1577|184|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1577|185|I|details.||
1577|186|I|   The risk of serotonin syndrome/toxicity increases if you are||
1577|187|I|also taking other drugs that increase serotonin. Examples include||
1577|188|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1577|189|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1577|190|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1577|191|I|serotonin syndrome/toxicity may be more likely when you start or||
1577|192|I|increase the dose of these drugs.||
1577|193|I|   Taking MAO inhibitors with this medication may cause a serious||
1577|194|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
1577|195|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1577|196|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1577|197|I|selegiline, tranylcypromine) during treatment with this||
1577|198|I|medication. Most MAO inhibitors should also not be taken for two||
1577|199|I|weeks before and 7 days after treatment with this medication. Ask||
1577|200|I|your doctor when to start or stop taking this medication.||
1577|201|I|   Levomilnacipran is very similar to milnacipran. Do not use||
1577|202|I|medications containing milnacipran while using levomilnacipran.||
1577|203|B|||
1577|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1577|205|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1577|206|O|poison control center right away. US residents can call||
1577|207|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1577|208|B|||
1577|209|N|NOTES:  Do not share this medication with others.||
1577|210|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
1577|211|N|should be done before you start taking this medication and while||
1577|212|N|you are taking it. Keep all medical and lab appointments. Consult||
1577|213|N|your doctor for more details.||
1577|214|B|||
1577|215|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1577|216|D|remember. If it is near the time of the next dose, skip the||
1577|217|D|missed dose. Take your next dose at the regular time. Do not||
1577|218|D|double the dose to catch up.||
1577|219|B|||
1577|220|R|STORAGE:  Store at room temperature away from light and moisture.||
1577|221|R|Do not store in the bathroom. Keep all medications away from||
1577|222|R|children and pets.||
1577|223|R|   Do not flush medications down the toilet or pour them into a||
1577|224|R|drain unless instructed to do so. Properly discard this product||
1577|225|R|when it is expired or no longer needed. Consult your pharmacist||
1577|226|R|or local waste disposal company.||
1577|227|B|||
1577|228|A|Information last revised February 2025.||
1577|229|A|Copyright(c) 2025 First Databank, Inc.||
1577|230|B|||
1579|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1579|002|Z|does NOT have all possible information about this product. This||
1579|003|Z|information does not assure that this product is safe, effective,||
1579|004|Z|or appropriate for you. This information is not individual||
1579|005|Z|medical advice and does not substitute for the advice of your||
1579|006|Z|health care professional. Always ask your health care||
1579|007|Z|professional for complete information about this product and your||
1579|008|Z|specific health needs.||
1579|009|B|||
1579|010|T|SOFOSBUVIR - ORAL||
1579|011|F|(soe-FOS-bue-vir)||
1579|012|B|||
1579|013|C|COMMON BRAND NAME(S): Sovaldi||
1579|014|B|||
1579|015|W|WARNING:  Although this medication is used to treat hepatitis C,||
1579|016|W|it may rarely make another liver problem called hepatitis B get||
1579|017|W|worse. Before starting this medication, tell your doctor if you||
1579|018|W|have ever had hepatitis B. Tell your doctor right away if you||
1579|019|W|have new or worsening symptoms of liver disease, such as||
1579|020|W|nausea/vomiting that doesn't stop, loss of appetite,||
1579|021|W|stomach/abdominal pain, dark urine or yellowing eyes/skin.||
1579|022|B|||
1579|023|U|USES:  Sofosbuvir is used with other antiviral medications (such||
1579|024|U|as ribavirin, peginterferon, daclatasvir) to treat chronic||
1579|025|U|(long-lasting) hepatitis C, a viral infection of the liver. It||
1579|026|U|works by reducing the amount of hepatitis C virus in your body,||
1579|027|U|which may help your liver recover. Chronic hepatitis C infection||
1579|028|U|can cause serious liver problems such as scarring (cirrhosis), or||
1579|029|U|liver cancer.||
1579|030|U|   Sofosbuvir in combination with other antiviral medications||
1579|031|U|reduces the amount of hepatitis C virus in the body and helps the||
1579|032|U|body's immune system fight the infection. It is not known if this||
1579|033|U|treatment can prevent you from passing the virus to others. Do||
1579|034|U|not share needles, and practice "safer sex" (including the use of||
1579|035|U|latex condoms) to lower the risk of passing the virus to others.||
1579|036|U|   Sofosbuvir must be used in combination treatment to have the||
1579|037|U|best effect. Do not use sofosbuvir alone to treat hepatitis C.||
1579|038|B|||
1579|039|H|HOW TO USE:  Read the Patient Information Leaflet and||
1579|040|H|Instructions for Use if available from your pharmacist before you||
1579|041|H|start taking sofosbuvir and each time you get a refill. If you||
1579|042|H|have any questions, ask your doctor or pharmacist. Also read the||
1579|043|H|drug information for your other antiviral medication(s).||
1579|044|H|   Take this medication by mouth with or without food as directed||
1579|045|H|by your doctor, usually once daily. The dosage is based on your||
1579|046|H|medical condition and response to treatment. Children's dosage is||
1579|047|H|also based on weight.||
1579|048|H|   If you are using the pellet form of this medication, gently||
1579|049|H|shake the packet before use. To take this medication without||
1579|050|H|food, open the packet and pour the pellets directly into your||
1579|051|H|mouth. Swallow the pellets without chewing. You may drink water||
1579|052|H|after swallowing the pellets if needed. Repeat these steps if||
1579|053|H|your dose is for more than one packet. If you are taking this||
1579|054|H|medication with food, open the packet(s) and pour the pellets||
1579|055|H|into a small bowl with one or more spoonfuls of non-acidic soft||
1579|056|H|food (such as pudding, mashed potato, ice cream). The soft food||
1579|057|H|should be at or below room temperature. After gently mixing, take||
1579|058|H|all of the mixture without chewing within 30 minutes.||
1579|059|H|   This medication works best when the amount of drug in your||
1579|060|H|body is kept at a constant level. Take this drug at evenly spaced||
1579|061|H|intervals. To help you remember, take it at the same time each||
1579|062|H|day.||
1579|063|H|   Continue to take sofosbuvir and your other antiviral||
1579|064|H|medication(s) for the full length of time prescribed, even if||
1579|065|H|your symptoms disappear after a short time. Stopping any of the||
1579|066|H|drugs too early may result in a return of the infection.||
1579|067|B|||
1579|068|S|SIDE EFFECTS:  See also Warning section.||
1579|069|S|   Tiredness, headache, nausea, diarrhea, itchy skin, difficulty||
1579|070|S|sleeping, or irritability may occur. If any of these effects last||
1579|071|S|or get worse, tell your doctor or pharmacist promptly.||
1579|072|S|   Remember that this medication has been prescribed because your||
1579|073|S|doctor has judged that the benefit to you is greater than the||
1579|074|S|risk of side effects. Many people using this medication do not||
1579|075|S|have serious side effects.||
1579|076|S|   Tell your doctor right away if you have any serious side||
1579|077|S|effects, including: signs of low red blood cell count (such as||
1579|078|S|unusual tiredness, rapid breathing, pale skin, shortness of||
1579|079|S|breath, fast heartbeat).||
1579|080|S|   A very serious allergic reaction to this drug is rare.||
1579|081|S|However, get medical help right away if you notice any symptoms||
1579|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1579|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1579|084|S|breathing.||
1579|085|S|   This is not a complete list of possible side effects. If you||
1579|086|S|notice other effects not listed above, contact your doctor or||
1579|087|S|pharmacist.||
1579|088|S|   In the US -||
1579|089|S|   Call your doctor for medical advice about side effects. You||
1579|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1579|091|S|www.fda.gov/medwatch.||
1579|092|S|   In Canada - Call your doctor for medical advice about side||
1579|093|S|effects. You may report side effects to Health Canada at||
1579|094|S|1-866-234-2345.||
1579|095|B|||
1579|096|P|PRECAUTIONS:  Before taking sofosbuvir, tell your doctor or||
1579|097|P|pharmacist if you are allergic to it; or if you have any other||
1579|098|P|allergies. This product may contain inactive ingredients, which||
1579|099|P|can cause allergic reactions or other problems. Talk to your||
1579|100|P|pharmacist for more details.||
1579|101|P|   Before using this medication, tell your doctor or pharmacist||
1579|102|P|your medical history, especially of: kidney disease, other liver||
1579|103|P|problems (such as hepatitis B), diabetes.||
1579|104|P|   If you have diabetes, your blood sugar may be lower with||
1579|105|P|hepatitis C treatment. This can increase your risk of low blood||
1579|106|P|sugar, so your doctor may adjust your diabetes treatment plan.||
1579|107|P|Tell your doctor right away if you have symptoms of low blood||
1579|108|P|sugar such as sudden sweating, shaking, fast heartbeat, hunger,||
1579|109|P|blurred vision, dizziness, or tingling hands/feet.||
1579|110|P|   Before having surgery, tell your doctor or dentist about all||
1579|111|P|the products you use (including prescription drugs,||
1579|112|P|nonprescription drugs, and herbal products).||
1579|113|P|   During pregnancy, sofosbuvir should be used only when clearly||
1579|114|P|needed. Sofosbuvir, in combination with ribavirin or||
1579|115|P|peginterferon, must not be used during pregnancy by either the||
1579|116|P|pregnant woman or her male partner. The combination may harm an||
1579|117|P|unborn baby. Reliable forms of birth control must be used||
1579|118|P|whenever at least one sexual partner is using these medicines||
1579|119|P|together. Female patients should keep using birth control for 9||
1579|120|P|months after stopping treatment. Male patients should keep using||
1579|121|P|birth control for 6 months after stopping treatment. If you or||
1579|122|P|your partner becomes pregnant, or if you think you or your||
1579|123|P|partner may be pregnant, tell your doctor right away.||
1579|124|P|   It is unknown if this medication passes into breast milk.||
1579|125|P|Consult your doctor before breastfeeding.||
1579|126|B|||
1579|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1579|128|I|medications work or increase your risk for serious side effects.||
1579|129|I|This document does not contain all possible drug interactions.||
1579|130|I|Keep a list of all the products you use (including||
1579|131|I|prescription/nonprescription drugs and herbal products) and share||
1579|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
1579|133|I|the dosage of any medicines without your doctor's approval.||
1579|134|I|   A product that may interact with this drug is: amiodarone.||
1579|135|I|   Other medications can affect the removal of sofosbuvir from||
1579|136|I|your body, which may affect how sofosbuvir works. Examples||
1579|137|I|include apalutamide, rifamycins (such as rifampin, rifabutin),||
1579|138|I|St. John's wort, tipranavir/ritonavir, drugs used to treat||
1579|139|I|seizures (such as carbamazepine, phenobarbital, phenytoin,||
1579|140|I|primidone), among others.||
1579|141|I|   Do not take this medication with other products that contain||
1579|142|I|sofosbuvir.||
1579|143|B|||
1579|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1579|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1579|146|O|poison control center right away. US residents can call||
1579|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1579|148|B|||
1579|149|N|NOTES:  Do not share this medication with others.||
1579|150|N|   Lab tests (such as liver function, tests for hepatitis B and||
1579|151|N|C) should be done before you start using this medication, while||
1579|152|N|you are using it, and after completing treatment. Keep all||
1579|153|N|medical and lab appointments.||
1579|154|N|   If you are using this medication with ribavirin, it is||
1579|155|N|recommended that female patients or female partners of male||
1579|156|N|patients take a pregnancy test before starting this medication.||
1579|157|N|Pregnancy tests should continue to be done while using this||
1579|158|N|medication and for some time after this medication is stopped to||
1579|159|N|make sure no pregnancy occurs (for 9 months for female patients||
1579|160|N|and for 6 months for female partners of male patients).||
1579|161|B|||
1579|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1579|163|D|remember. If it is near the time of the next dose, skip the||
1579|164|D|missed dose. Take your next dose at the regular time. Do not||
1579|165|D|double the dose to catch up.||
1579|166|B|||
1579|167|R|STORAGE:  Store at room temperature away from light and moisture.||
1579|168|R|Store the tablets in the original container. For the pellets, do||
1579|169|R|not open the packets until you are ready to use the medication.||
1579|170|R|Do not store in the bathroom. Keep all medications away from||
1579|171|R|children and pets.||
1579|172|R|   Do not flush medications down the toilet or pour them into a||
1579|173|R|drain unless instructed to do so. Properly discard this product||
1579|174|R|when it is expired or no longer needed. Consult your pharmacist||
1579|175|R|or local waste disposal company.||
1579|176|B|||
1579|177|A|Information last revised August 2024.||
1579|178|A|Copyright(c) 2025 First Databank, Inc.||
1579|179|B|||
1580|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1580|002|Z|does NOT have all possible information about this product. This||
1580|003|Z|information does not assure that this product is safe, effective,||
1580|004|Z|or appropriate for you. This information is not individual||
1580|005|Z|medical advice and does not substitute for the advice of your||
1580|006|Z|health care professional. Always ask your health care||
1580|007|Z|professional for complete information about this product and your||
1580|008|Z|specific health needs.||
1580|009|B|||
1580|010|T|SUCRALFATE - DENTAL||
1580|011|F|(soo-KRAL-fate)||
1580|012|B|||
1580|013|C|COMMON BRAND NAME(S): Orafate, ProThelial||
1580|014|B|||
1580|015|U|USES:  This medication is used for relief of mouth sores (such as||
1580|016|U|those caused by canker sores, cold sores, braces, radiation||
1580|017|U|treatment, cancer treatment). It may also be used for the||
1580|018|U|temporary relief of mouth pain due to procedures such as dental||
1580|019|U|cleaning, tooth extraction, or removal of tonsils or the uvula||
1580|020|U|(the small bit of flesh hanging down in the back of your throat).||
1580|021|U|This drug comes in a dental paste or gel that allows it to stick||
1580|022|U|to the inside of the mouth/cheeks/gums. It works by forming a||
1580|023|U|protective layer to help prevent further irritation and pain.||
1580|024|B|||
1580|025|H|HOW TO USE:  Do not apply this medication in the eyes or on the||
1580|026|H|skin. Use it only inside the mouth.||
1580|027|H|   Use this product as directed by your dentist or doctor. The||
1580|028|H|dosage and directions for use are based on your medical condition||
1580|029|H|and response to treatment. Different brands of this medication||
1580|030|H|have different directions for use. Carefully follow your doctor||
1580|031|H|or dentist's directions for using this product.||
1580|032|H|   Although not intended to be swallowed, this medication is safe||
1580|033|H|if swallowed.||
1580|034|H|   Avoid eating or drinking for at least 1 hour after use.||
1580|035|H|   Use this medication regularly to get the most benefit from it.||
1580|036|H|To help you remember, use it at the same times each day. Do not||
1580|037|H|increase your dose or use this product more often or for a longer||
1580|038|H|time than directed by your doctor or dentist. Do not use more||
1580|039|H|than 8 teaspoonsful (40 milliliters) a day.||
1580|040|H|   Tell your doctor or dentist if your condition lasts or gets||
1580|041|H|worse.||
1580|042|B|||
1580|043|S|SIDE EFFECTS:  This medication usually has very few side effects.||
1580|044|S|However, if this medication is swallowed, constipation may occur.||
1580|045|S|If you have any unusual effects, tell your doctor, dentist, or||
1580|046|S|pharmacist promptly.||
1580|047|S|   Remember that this medication has been prescribed because your||
1580|048|S|doctor or dentist has judged that the benefit to you is greater||
1580|049|S|than the risk of side effects. Many people using this medication||
1580|050|S|do not have serious side effects.||
1580|051|S|   A very serious allergic reaction to this drug is rare.||
1580|052|S|However, get medical help right away if you notice any symptoms||
1580|053|S|of a serious allergic reaction, including: rash, itching/swelling||
1580|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1580|055|S|breathing.||
1580|056|S|   This is not a complete list of possible side effects. If you||
1580|057|S|notice other effects not listed above, contact your doctor or||
1580|058|S|pharmacist.||
1580|059|S|   In the US -||
1580|060|S|   Call your doctor for medical advice about side effects. You||
1580|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1580|062|S|www.fda.gov/medwatch.||
1580|063|S|   In Canada - Call your doctor for medical advice about side||
1580|064|S|effects. You may report side effects to Health Canada at||
1580|065|S|1-866-234-2345.||
1580|066|B|||
1580|067|P|PRECAUTIONS:  Before using sucralfate, tell your doctor or||
1580|068|P|pharmacist if you are allergic to it; or if you have any other||
1580|069|P|allergies. This product may contain inactive ingredients, which||
1580|070|P|can cause allergic reactions or other problems. Talk to your||
1580|071|P|pharmacist for more details.||
1580|072|P|   Before using this medication, tell your doctor, dentist, or||
1580|073|P|pharmacist your medical history.||
1580|074|P|   Before having surgery, tell your doctor or dentist about all||
1580|075|P|the products you use (including prescription drugs,||
1580|076|P|nonprescription drugs, and herbal products).||
1580|077|P|   This product is safe to use during pregnancy when used as||
1580|078|P|directed.||
1580|079|P|   It is unknown if this medication passes into breast milk.||
1580|080|P|However, it is unlikely to pass into breast milk. Consult your||
1580|081|P|doctor before breastfeeding.||
1580|082|B|||
1580|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1580|084|I|medications work or increase your risk for serious side effects.||
1580|085|I|This document does not contain all possible drug interactions.||
1580|086|I|Keep a list of all the products you use (including||
1580|087|I|prescription/nonprescription drugs and herbal products) and share||
1580|088|I|it with your doctor, dentist, and pharmacist. Do not start, stop,||
1580|089|I|or change the dosage of any medicines without your doctor's||
1580|090|I|approval.||
1580|091|B|||
1580|092|O|OVERDOSE:  Overdose with this medication is unlikely even if||
1580|093|O|swallowed. However, if someone has overdosed and has serious||
1580|094|O|symptoms such as passing out or trouble breathing, call 911.||
1580|095|O|Otherwise, call a poison control center right away. US residents||
1580|096|O|can call 1-800-222-1222. Canada residents can call||
1580|097|O|1-844-764-7669.||
1580|098|B|||
1580|099|N|NOTES:  Do not share this medication with others.||
1580|100|N|   This medication has been prescribed for your current condition||
1580|101|N|only. Do not use it later for another condition unless your||
1580|102|N|doctor or dentist directs you to do so. A different medication||
1580|103|N|may be necessary in that case.||
1580|104|B|||
1580|105|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1580|106|D|If it is near the time of the next dose, skip the missed dose.||
1580|107|D|Use your next dose at the regular time. Do not double the dose to||
1580|108|D|catch up.||
1580|109|B|||
1580|110|R|STORAGE:  Store at room temperature. Keep all medications away||
1580|111|R|from children and pets.||
1580|112|R|   Do not flush medications down the toilet or pour them into a||
1580|113|R|drain unless instructed to do so. Properly discard this product||
1580|114|R|when it is expired or no longer needed. Consult your pharmacist||
1580|115|R|or local waste disposal company.||
1580|116|B|||
1580|117|A|Information last revised September 2024.||
1580|118|A|Copyright(c) 2025 First Databank, Inc.||
1580|119|B|||
1581|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1581|002|Z|does NOT have all possible information about this product. This||
1581|003|Z|information does not assure that this product is safe, effective,||
1581|004|Z|or appropriate for you. This information is not individual||
1581|005|Z|medical advice and does not substitute for the advice of your||
1581|006|Z|health care professional. Always ask your health care||
1581|007|Z|professional for complete information about this product and your||
1581|008|Z|specific health needs.||
1581|009|B|||
1581|010|T|METHOTREXATE - SUBCUTANEOUS INJECTION||
1581|011|F|(METH-oh-TREX-ate)||
1581|012|B|||
1581|013|C|COMMON BRAND NAME(S): Otrexup, Rasuvo||
1581|014|B|||
1581|015|W|WARNING:  Methotrexate has rarely caused serious (sometimes||
1581|016|W|fatal) side effects. This medication should be used only to treat||
1581|017|W|severe diseases caused by an overactive immune system (such as||
1581|018|W|psoriasis, rheumatoid arthritis).||
1581|019|W|   Methotrexate has caused birth defects and death in unborn||
1581|020|W|babies. Women must avoid becoming pregnant while using this||
1581|021|W|medication. Pregnant women who have psoriasis or rheumatoid||
1581|022|W|arthritis must not use methotrexate. (See also Precautions||
1581|023|W|section.)||
1581|024|W|   If you have kidney problems or excess body water (ascites,||
1581|025|W|pleural effusion), you must be closely monitored and your dose||
1581|026|W|may be adjusted or stopped by your doctor.||
1581|027|W|   Methotrexate (usually at high dosages) has rarely caused||
1581|028|W|severe (sometimes fatal) blood/bone marrow problems (decreasing||
1581|029|W|your body's ability to fight infections) and stomach/intestinal||
1581|030|W|disease (such as bleeding) when used at the same time as||
1581|031|W|non-steroidal anti-inflammatory drugs (NSAIDs such as||
1581|032|W|indomethacin, ketoprofen). NSAIDs should not be used with||
1581|033|W|high-dose methotrexate. Caution is advised if you also take||
1581|034|W|aspirin. NSAIDs/aspirin may be used with low-dose methotrexate||
1581|035|W|such as for the treatment of rheumatoid arthritis if directed by||
1581|036|W|your doctor. If your doctor has told you to take low-dose aspirin||
1581|037|W|to prevent heart attack or stroke (usually 81-162 milligrams a||
1581|038|W|day), you should keep taking the aspirin unless your doctor tells||
1581|039|W|you not to. Ask your doctor or pharmacist for more details on the||
1581|040|W|safe use of these drugs (such as close monitoring by your doctor,||
1581|041|W|keeping the same doses of NSAIDs).||
1581|042|W|   In rare instances, this drug may also cause liver problems||
1581|043|W|when it is used for long periods of time. If you are using||
1581|044|W|methotrexate long term, a liver biopsy is usually recommended.||
1581|045|W|   Methotrexate use has rarely caused serious (sometimes fatal)||
1581|046|W|side effects, such as lung problems, lung infections||
1581|047|W|(Pneumocystis jiroveci pneumonia), skin reactions, diarrhea, and||
1581|048|W|mouth sores (ulcerative stomatitis). (See also Side Effects||
1581|049|W|section.)||
1581|050|W|   Lumps (tumors/abnormal growths) may very rarely appear during||
1581|051|W|methotrexate use. The drug must be stopped and treatment may be||
1581|052|W|needed. Tell your doctor right away if new lumps/growths occur.||
1581|053|W|   When used to treat tumors, methotrexate sometimes causes side||
1581|054|W|effects due to the rapid destruction of cancer cells (tumor lysis||
1581|055|W|syndrome). To lower your risk, drink plenty of fluids unless your||
1581|056|W|doctor directs you otherwise. Also, your doctor may prescribe an||
1581|057|W|additional medication. Tell your doctor right away if you have||
1581|058|W|symptoms such as irregular heartbeat, low back/side pain, signs||
1581|059|W|of kidney problems (such as pink/bloody urine, change in the||
1581|060|W|amount of urine, painful urination), or muscle spasms/weakness.||
1581|061|W|   When this medication is used with radiation treatment, it may||
1581|062|W|rarely increase the risk of tissue and bone damage. Discuss the||
1581|063|W|risks and benefits of your treatment with your doctor.||
1581|064|B|||
1581|065|U|USES:  Methotrexate is used to treat severe psoriasis that has||
1581|066|U|not responded to other treatments or rheumatoid arthritis. It may||
1581|067|U|also be used to treat a certain type of arthritis in children||
1581|068|U|(polyarticular juvenile idiopathic arthritis - pJIA).||
1581|069|U|Methotrexate belongs to a class of drugs known as||
1581|070|U|antimetabolites. It works by blocking the immune system from||
1581|071|U|attacking healthy tissue.||
1581|072|U|   Early treatment of rheumatoid arthritis with methotrexate||
1581|073|U|helps to reduce further joint damage and to preserve joint||
1581|074|U|function.||
1581|075|B|||
1581|076|V|OTHER USES:  This section contains uses of this drug that are not||
1581|077|V|listed in the approved professional labeling for the drug but||
1581|078|V|that may be prescribed by your health care professional. Use this||
1581|079|V|drug for a condition that is listed in this section only if it||
1581|080|V|has been so prescribed by your health care professional.||
1581|081|V|   This medication may also be used for lupus, psoriatic||
1581|082|V|arthritis, and Crohn's disease.||
1581|083|B|||
1581|084|H|HOW TO USE:  Read the Patient Information Leaflet and||
1581|085|H|Instructions for Use if available from your pharmacist before you||
1581|086|H|start using methotrexate and each time you get a refill. Ask your||
1581|087|H|health care professional how to prepare and use this medication.||
1581|088|H|If you have any questions, ask your doctor or pharmacist.||
1581|089|H|   Inject this medication under the skin as directed by your||
1581|090|H|doctor, usually once a week. The injection is given in the thighs||
1581|091|H|or abdomen. Some brands may also be given in the upper arms. The||
1581|092|H|dosage is based on your medical condition and response to||
1581|093|H|treatment.||
1581|094|H|   Before using, check this product for particles or||
1581|095|H|discoloration. If either is present, do not use the liquid.||
1581|096|H|Before injecting each dose, clean the skin you are going to||
1581|097|H|inject into (the injection site) with rubbing alcohol. Change the||
1581|098|H|injection site each time to lessen injury under the skin. Do not||
1581|099|H|inject into skin that is red, swollen, or bruised, or into areas||
1581|100|H|with scars/stretch marks. To lessen bruising, do not rub the||
1581|101|H|injection site after a shot. Learn how to store and discard||
1581|102|H|medical supplies safely.||
1581|103|H|   Use this medication regularly to get the most benefit from it.||
1581|104|H|To help you remember, use it on the same day each week. Mark your||
1581|105|H|calendar with a reminder.||
1581|106|H|   Do not increase your dose or use this drug more often or for||
1581|107|H|longer than prescribed. Your condition will not improve any||
1581|108|H|faster, and your risk of side effects will increase.||
1581|109|H|   It may take up to several months before you get the full||
1581|110|H|benefit of this drug.||
1581|111|H|   Tell your doctor if your condition does not get better or if||
1581|112|H|it gets worse.||
1581|113|B|||
1581|114|S|SIDE EFFECTS:  See also Warning section.||
1581|115|S|   Nausea, vomiting, stomach pain, drowsiness, or dizziness may||
1581|116|S|occur. If any of these effects last or get worse, tell your||
1581|117|S|doctor or pharmacist promptly.||
1581|118|S|   Temporary hair loss may occur. Normal hair growth should||
1581|119|S|return after treatment has ended.||
1581|120|S|   Remember that this medication has been prescribed because your||
1581|121|S|doctor has judged that the benefit to you is greater than the||
1581|122|S|risk of side effects. Many people using this medication do not||
1581|123|S|have serious side effects.||
1581|124|S|   Tell your doctor right away if you have any serious side||
1581|125|S|effects, including: mouth sores, diarrhea, signs of anemia (such||
1581|126|S|as unusual tiredness, pale skin), signs of liver problems (such||
1581|127|S|as nausea/vomiting that doesn't stop, dark urine,||
1581|128|S|stomach/abdominal pain, yellowing eyes/skin), easy||
1581|129|S|bruising/bleeding, black stools, swollen lymph nodes, bone pain,||
1581|130|S|unusual pain and discoloration of the skin, signs of kidney||
1581|131|S|problems (such as change in the amount of urine), dry cough,||
1581|132|S|muscle weakness.||
1581|133|S|   Get medical help right away if you have any very serious side||
1581|134|S|effects, including: irregular heartbeat, vision changes, weakness||
1581|135|S|on one side of the body, severe headache, neck stiffness,||
1581|136|S|mental/mood changes, seizures.||
1581|137|S|   This medication may lower your ability to fight infections.||
1581|138|S|This may make you more likely to get a serious (rarely fatal)||
1581|139|S|infection or make any infection you have worse. Tell your doctor||
1581|140|S|right away if you have any signs of infection (such as sore||
1581|141|S|throat that doesn't go away, fever, chills).||
1581|142|S|   A very serious allergic reaction to this drug is rare.||
1581|143|S|However, get medical help right away if you notice any symptoms||
1581|144|S|of a serious allergic reaction, including: rash, itching/swelling||
1581|145|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1581|146|S|breathing.||
1581|147|S|   This is not a complete list of possible side effects. If you||
1581|148|S|notice other effects not listed above, contact your doctor or||
1581|149|S|pharmacist.||
1581|150|S|   In the US -||
1581|151|S|   Call your doctor for medical advice about side effects. You||
1581|152|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1581|153|S|www.fda.gov/medwatch.||
1581|154|S|   In Canada - Call your doctor for medical advice about side||
1581|155|S|effects. You may report side effects to Health Canada at||
1581|156|S|1-866-234-2345.||
1581|157|B|||
1581|158|P|PRECAUTIONS:  See also Warning section.||
1581|159|P|   Before using methotrexate, tell your doctor or pharmacist if||
1581|160|P|you are allergic to it; or if you have any other allergies. This||
1581|161|P|product may contain inactive ingredients, which can cause||
1581|162|P|allergic reactions or other problems. Talk to your pharmacist for||
1581|163|P|more details.||
1581|164|P|   Before using this medication, tell your doctor or pharmacist||
1581|165|P|your medical history, especially of: liver disease, kidney||
1581|166|P|disease, lung disease (such as pulmonary fibrosis), alcohol use,||
1581|167|P|suppressed immune system, blood cell/bone marrow disorders,||
1581|168|P|certain stomach/intestinal diseases (such as peptic ulcer,||
1581|169|P|ulcerative colitis), any active infection (including chickenpox||
1581|170|P|or recent exposure to it), folic acid deficiency.||
1581|171|P|   Methotrexate can make you more likely to get infections or may||
1581|172|P|make current infections worse. Stay away from anyone who has an||
1581|173|P|infection that may easily spread (such as chickenpox, COVID-19,||
1581|174|P|measles, flu). Talk to your doctor if you have been exposed to an||
1581|175|P|infection or for more details.||
1581|176|P|   Tell your health care professional that you are using||
1581|177|P|methotrexate before having any immunizations/vaccinations. Avoid||
1581|178|P|contact with people who have recently received live vaccines||
1581|179|P|(such as flu vaccine inhaled through the nose).||
1581|180|P|   To lower the chance of getting cut, bruised, or injured, use||
1581|181|P|caution with sharp objects like razors and nail cutters, and||
1581|182|P|avoid activities such as contact sports.||
1581|183|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1581|184|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1581|185|P|machinery, or do anything that needs alertness until you can do||
1581|186|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1581|187|P|are using marijuana (cannabis).||
1581|188|P|   Before having surgery, tell your doctor or dentist about all||
1581|189|P|the products you use (including prescription drugs,||
1581|190|P|nonprescription drugs, and herbal products).||
1581|191|P|   Children may be more sensitive to the side effects of this||
1581|192|P|drug, especially seizures.||
1581|193|P|   This medication may make you more sensitive to the sun. Limit||
1581|194|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1581|195|P|sunscreen and wear protective clothing when outdoors. Tell your||
1581|196|P|doctor right away if you get sunburned or have skin||
1581|197|P|blisters/redness.||
1581|198|P|   This medication can affect fertility in both males and||
1581|199|P|females. Ask your doctor for more details.||
1581|200|P|   Methotrexate must not be used during pregnancy. It may harm an||
1581|201|P|unborn baby. Your doctor should order a pregnancy test before you||
1581|202|P|start this medication. You should not become pregnant while using||
1581|203|P|methotrexate. Women using this medication should ask about||
1581|204|P|reliable forms of birth control during treatment and for 6 months||
1581|205|P|after the last dose. Men using this medication should ask about||
1581|206|P|reliable forms of birth control during treatment and for some||
1581|207|P|time after the last dose. If you or your partner become pregnant,||
1581|208|P|or think you are pregnant, talk to your doctor right away about||
1581|209|P|the risks and benefits of this medication.||
1581|210|P|   Methotrexate passes into breast milk and may harm a nursing||
1581|211|P|infant. Breastfeeding is not recommended while using this||
1581|212|P|medication and for at least 1 week after the last dose. Consult||
1581|213|P|your doctor before breastfeeding.||
1581|214|B|||
1581|215|I|DRUG INTERACTIONS:  See also Warning section.||
1581|216|I|   Drug interactions may change how your medications work or||
1581|217|I|increase your risk for serious side effects. This document does||
1581|218|I|not contain all possible drug interactions. Keep a list of all||
1581|219|I|the products you use (including prescription/nonprescription||
1581|220|I|drugs and herbal products) and share it with your doctor and||
1581|221|I|pharmacist. Do not start, stop, or change the dosage of any||
1581|222|I|medicines without your doctor's approval.||
1581|223|I|   Some products that may interact with this drug include:||
1581|224|I|acitretin, asparaginase, leflunomide.||
1581|225|I|   Other medications can affect the removal of methotrexate from||
1581|226|I|your body, which may affect how methotrexate works. Examples||
1581|227|I|include penicillins, probenecid, proton pump inhibitors-PPIs||
1581|228|I|(such as esomeprazole, omeprazole, pantoprazole), sulfa||
1581|229|I|medications, among others.||
1581|230|B|||
1581|231|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1581|232|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1581|233|O|poison control center right away. US residents can call||
1581|234|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1581|235|O|Symptoms of overdose may include severe nausea and vomiting, and||
1581|236|O|bloody stools.||
1581|237|B|||
1581|238|N|NOTES:  Do not share this medication with others.||
1581|239|N|   Lab and/or medical tests (such as complete blood cell counts,||
1581|240|N|liver/kidney function, pregnancy test, chest X-ray) should be||
1581|241|N|done before you start using this medication and while you are||
1581|242|N|using it. Keep all medical and lab appointments. Consult your||
1581|243|N|doctor for more details.||
1581|244|B|||
1581|245|D|MISSED DOSE:  It is important to get each dose of this medication||
1581|246|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1581|247|D|right away for a new dosing schedule. Do not double the dose to||
1581|248|D|catch up.||
1581|249|B|||
1581|250|R|STORAGE:  Store at room temperature away from light. Keep all||
1581|251|R|medications away from children and pets.||
1581|252|R|   Do not flush medications down the toilet or pour them into a||
1581|253|R|drain unless instructed to do so. Properly discard this product||
1581|254|R|when it is expired or no longer needed. Consult your pharmacist||
1581|255|R|or local waste disposal company.||
1581|256|B|||
1581|257|M|MEDICAL ALERT:  Your condition can cause complications in a||
1581|258|M|medical emergency. For information about enrolling in MedicAlert,||
1581|259|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1581|260|B|||
1581|261|A|Information last revised August 2025.||
1581|262|A|Copyright(c) 2025 First Databank, Inc.||
1581|263|B|||
1582|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1582|002|Z|does NOT have all possible information about this product. This||
1582|003|Z|information does not assure that this product is safe, effective,||
1582|004|Z|or appropriate for you. This information is not individual||
1582|005|Z|medical advice and does not substitute for the advice of your||
1582|006|Z|health care professional. Always ask your health care||
1582|007|Z|professional for complete information about this product and your||
1582|008|Z|specific health needs.||
1582|009|B|||
1582|010|T|AVANAFIL - ORAL||
1582|011|F|(a-VAN-a-fil)||
1582|012|B|||
1582|013|C|COMMON BRAND NAME(S): Stendra||
1582|014|B|||
1582|015|U|USES:  Avanafil is used to treat male sexual function problems||
1582|016|U|(impotence or erectile dysfunction-ED). In combination with||
1582|017|U|sexual stimulation, avanafil works by increasing blood flow to||
1582|018|U|the penis to help a man get and keep an erection.||
1582|019|U|   This drug does not protect against sexually transmitted||
1582|020|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1582|021|U|an effective barrier method (latex or polyurethane condom/dental||
1582|022|U|dams) during sexual activity will help to decrease your risk of||
1582|023|U|infection.||
1582|024|B|||
1582|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1582|026|H|from your pharmacist before you start taking avanafil and each||
1582|027|H|time you get a refill. If you have any questions, ask your doctor||
1582|028|H|or pharmacist.||
1582|029|H|   Take this medication by mouth with or without food as directed||
1582|030|H|by your doctor, usually as needed. This medication is available||
1582|031|H|in different doses. Depending on your dose, take avanafil about||
1582|032|H|15 minutes or 30 minutes before sexual activity. Follow your||
1582|033|H|doctor's instructions carefully on how many minutes before sexual||
1582|034|H|activity you should take this medication. Do not take more than||
1582|035|H|once daily.||
1582|036|H|   The dosage is based on your medical condition, response to||
1582|037|H|treatment, and other medications you may be taking. Be sure to||
1582|038|H|tell your doctor and pharmacist about all the products you use||
1582|039|H|(including prescription drugs, nonprescription drugs, and herbal||
1582|040|H|products).||
1582|041|H|   Tell your doctor if your condition does not get better.||
1582|042|B|||
1582|043|S|SIDE EFFECTS:  Headache, flushing, or dizziness may occur. If any||
1582|044|S|of these effects last or get worse, tell your doctor or||
1582|045|S|pharmacist promptly.||
1582|046|S|   To reduce the risk of dizziness and lightheadedness, get up||
1582|047|S|slowly when rising from a sitting or lying position.||
1582|048|S|   Remember that this medication has been prescribed because your||
1582|049|S|doctor has judged that the benefit to you is greater than the||
1582|050|S|risk of side effects. Many people using this medication do not||
1582|051|S|have serious side effects.||
1582|052|S|   Sexual activity may put extra strain on your heart, especially||
1582|053|S|if you have heart problems. If you have heart problems and||
1582|054|S|experience any of these serious side effects while having sex,||
1582|055|S|stop and get medical help right away: severe dizziness, fainting,||
1582|056|S|chest/jaw/left arm pain, nausea.||
1582|057|S|   Rarely, sudden decreased vision, including permanent||
1582|058|S|blindness, in one or both eyes (NAION) may occur. If this serious||
1582|059|S|problem occurs, stop taking avanafil and get medical help right||
1582|060|S|away. You have a slightly greater chance of developing NAION if||
1582|061|S|you have heart disease, diabetes, high cholesterol, certain other||
1582|062|S|eye problems ("crowded disk"), high blood pressure, if you are||
1582|063|S|over 50, or if you smoke.||
1582|064|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
1582|065|S|ringing in the ears and dizziness, may occur. Stop taking||
1582|066|S|avanafil and get medical help right away if these effects occur.||
1582|067|S|   In the rare event you have a painful or prolonged erection||
1582|068|S|lasting 4 or more hours, stop using this drug and get medical||
1582|069|S|help right away, or permanent problems could occur.||
1582|070|S|   A very serious allergic reaction to this drug is rare.||
1582|071|S|However, get medical help right away if you notice any symptoms||
1582|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1582|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1582|074|S|breathing.||
1582|075|S|   This is not a complete list of possible side effects. If you||
1582|076|S|notice other effects not listed above, contact your doctor or||
1582|077|S|pharmacist.||
1582|078|S|   In the US -||
1582|079|S|   Call your doctor for medical advice about side effects. You||
1582|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1582|081|S|www.fda.gov/medwatch.||
1582|082|S|   In Canada - Call your doctor for medical advice about side||
1582|083|S|effects. You may report side effects to Health Canada at||
1582|084|S|1-866-234-2345.||
1582|085|B|||
1582|086|P|PRECAUTIONS:  Before taking avanafil, tell your doctor or||
1582|087|P|pharmacist if you are allergic to it; or if you have any other||
1582|088|P|allergies. This product may contain inactive ingredients, which||
1582|089|P|can cause allergic reactions or other problems. Talk to your||
1582|090|P|pharmacist for more details.||
1582|091|P|   Before using this medication, tell your doctor or pharmacist||
1582|092|P|your medical history, especially of: heart problems (such as||
1582|093|P|heart attack or life-threatening irregular heartbeat in the past||
1582|094|P|6 months, chest pain/angina, heart failure), stroke in the past 6||
1582|095|P|months, kidney disease (dialysis), liver disease, high or low||
1582|096|P|blood pressure, dehydration, penis conditions (such as||
1582|097|P|angulation, fibrosis/scarring, Peyronie's disease), history of||
1582|098|P|painful/prolonged erection (priapism), conditions that may||
1582|099|P|increase the risk of priapism (such as sickle cell anemia,||
1582|100|P|leukemia, multiple myeloma), eye problems (such as retinitis||
1582|101|P|pigmentosa, sudden decreased vision, NAION), bleeding disorders,||
1582|102|P|active stomach ulcers.||
1582|103|P|   This drug may make you dizzy or cause vision changes. Alcohol||
1582|104|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
1582|105|P|use machinery, or do anything that needs alertness or clear||
1582|106|P|vision until you can do it safely. Limit alcoholic beverages.||
1582|107|P|Talk to your doctor if you are using marijuana (cannabis).||
1582|108|P|   Before having surgery, tell your doctor or dentist about all||
1582|109|P|the products you use (including prescription drugs,||
1582|110|P|nonprescription drugs, and herbal products).||
1582|111|P|   This medication is not usually used in women. It is unlikely||
1582|112|P|to be used during pregnancy or breastfeeding. Consult your doctor||
1582|113|P|if you have any questions about this medication.||
1582|114|B|||
1582|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1582|116|I|medications work or increase your risk for serious side effects.||
1582|117|I|This document does not contain all possible drug interactions.||
1582|118|I|Keep a list of all the products you use (including||
1582|119|I|prescription/nonprescription drugs and herbal products) and share||
1582|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1582|121|I|the dosage of any medicines without your doctor's approval.||
1582|122|I|   Some products that may interact with this drug are: riociguat,||
1582|123|I|vericiguat.||
1582|124|I|   Avanafil can cause a serious drop in your blood pressure when||
1582|125|I|used with nitrates, which can lead to dizziness, fainting, and||
1582|126|I|rarely heart attack or stroke. Do not use avanafil with any of||
1582|127|I|the following: certain drugs used to treat chest pain/angina||
1582|128|I|(nitrates such as nitroglycerin, isosorbide), recreational drugs||
1582|129|I|called "poppers" containing amyl or butyl nitrite.||
1582|130|I|   If you are also taking an alpha blocker medication (such as||
1582|131|I|doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high||
1582|132|I|blood pressure, your blood pressure may get too low which can||
1582|133|I|lead to dizziness or fainting. Your doctor may start treatment||
1582|134|I|with a lower dose of avanafil to minimize your risk of low blood||
1582|135|I|pressure.||
1582|136|I|   Other medications can affect the removal of avanafil from your||
1582|137|I|body, which may affect how avanafil works. Examples include||
1582|138|I|adagrasib, azole antifungals (such as itraconazole,||
1582|139|I|ketoconazole), cobicistat, clarithromycin, HIV protease||
1582|140|I|inhibitors (such as tipranavir), nefazodone, ribociclib,||
1582|141|I|rifampin, ritonavir, among others.||
1582|142|I|   Do not take this medication with any other product that||
1582|143|I|contains avanafil or other similar medications used to treat||
1582|144|I|erectile dysfunction-ED or pulmonary hypertension (such as||
1582|145|I|sildenafil, tadalafil, vardenafil).||
1582|146|B|||
1582|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1582|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1582|149|O|poison control center right away. US residents can call||
1582|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1582|151|B|||
1582|152|N|NOTES:  Do not share this medication with others.||
1582|153|B|||
1582|154|D|MISSED DOSE:  Not applicable.||
1582|155|B|||
1582|156|R|STORAGE:  Store at room temperature away from light and moisture.||
1582|157|R|Do not store in the bathroom. Keep all medications away from||
1582|158|R|children and pets.||
1582|159|R|   Do not flush medications down the toilet or pour them into a||
1582|160|R|drain unless instructed to do so. Properly discard this product||
1582|161|R|when it is expired or no longer needed. Consult your pharmacist||
1582|162|R|or local waste disposal company.||
1582|163|B|||
1582|164|A|Information last revised October 2025.||
1582|165|A|Copyright(c) 2025 First Databank, Inc.||
1582|166|B|||
1584|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1584|002|Z|does NOT have all possible information about this product. This||
1584|003|Z|information does not assure that this product is safe, effective,||
1584|004|Z|or appropriate for you. This information is not individual||
1584|005|Z|medical advice and does not substitute for the advice of your||
1584|006|Z|health care professional. Always ask your health care||
1584|007|Z|professional for complete information about this product and your||
1584|008|Z|specific health needs.||
1584|009|B|||
1584|010|T|DAPAGLIFLOZIN - ORAL||
1584|011|F|(DAP-a-gli-FLOE-zin)||
1584|012|B|||
1584|013|C|COMMON BRAND NAME(S): Farxiga||
1584|014|B|||
1584|015|U|USES:  Dapagliflozin is used with a proper diet and exercise||
1584|016|U|program to control high blood sugar in people with type 2||
1584|017|U|diabetes. Controlling high blood sugar helps prevent kidney||
1584|018|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1584|019|U|function problems. Proper control of diabetes may also lessen||
1584|020|U|your risk of a heart attack or stroke. This medication is also||
1584|021|U|used in people with type 2 diabetes and heart disease to lower||
1584|022|U|the risk of going to the hospital for heart failure.||
1584|023|U|Dapagliflozin works by increasing the removal of sugar by your||
1584|024|U|kidneys.||
1584|025|U|   Dapagliflozin is also used to treat kidney disease and heart||
1584|026|U|failure. It helps to lower the risk of death from heart disease||
1584|027|U|and reduces the need of going to a doctor or hospital to treat||
1584|028|U|heart failure. Dapagliflozin works by increasing the removal of||
1584|029|U|sodium by your kidneys.||
1584|030|B|||
1584|031|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1584|032|H|Patient Information Leaflet provided by your pharmacist before||
1584|033|H|you start taking dapagliflozin and each time you get a refill. If||
1584|034|H|you have any questions, ask your doctor or pharmacist.||
1584|035|H|   Take this medication by mouth with or without food as directed||
1584|036|H|by your doctor, usually once daily. The dosage is based on your||
1584|037|H|medical condition and response to treatment.||
1584|038|H|   Use this medication regularly to get the most benefit from it.||
1584|039|H|To help you remember, take it at the same time each day.||
1584|040|H|   Tell your doctor if your condition does not get better or if||
1584|041|H|it gets worse.||
1584|042|B|||
1584|043|S|SIDE EFFECTS:  Frequent urination, dizziness, or lightheadedness||
1584|044|S|may occur. If any of these effects last or get worse, tell your||
1584|045|S|doctor or pharmacist promptly.||
1584|046|S|   To reduce the risk of dizziness and lightheadedness, get up||
1584|047|S|slowly when rising from a sitting or lying position.||
1584|048|S|   Remember that this medication has been prescribed because your||
1584|049|S|doctor has judged that the benefit to you is greater than the||
1584|050|S|risk of side effects. Many people using this medication do not||
1584|051|S|have serious side effects.||
1584|052|S|   Tell your doctor right away if you have any serious side||
1584|053|S|effects, including: signs of a urinary tract infection (such as||
1584|054|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1584|055|S|signs of kidney problems (such as change in the amount of urine,||
1584|056|S|swelling legs/feet).||
1584|057|S|   Get medical help right away if you have any very serious side||
1584|058|S|effects, including: unusual tiredness, nausea/vomiting,||
1584|059|S|stomach/abdominal pain, trouble breathing.||
1584|060|S|   Dapagliflozin can sometimes cause painful urination or||
1584|061|S|pink/bloody urine that are usually signs of a urinary tract||
1584|062|S|infection, but they may also be signs of a rare condition||
1584|063|S|(bladder cancer). Bladder cancer may or may not be caused by||
1584|064|S|dapagliflozin. Tell your doctor right away if you develop these||
1584|065|S|symptoms.||
1584|066|S|   This medication may cause a new yeast infection in the vagina||
1584|067|S|or the penis. It may also cause a rare but very serious bacterial||
1584|068|S|infection in the genital/anal area (Fournier's gangrene) in||
1584|069|S|people with type 2 diabetes. Tell your doctor right away if you||
1584|070|S|have signs of a yeast infection in the vagina (such as unusual||
1584|071|S|vaginal discharge/burning/itching/odor) or in the penis (such as||
1584|072|S|redness/itching/swelling of the penis, unusual discharge from the||
1584|073|S|penis). However, get medical help right away if you have any||
1584|074|S|pain/redness/swelling in or around the genital/anal area, along||
1584|075|S|with a fever or feeling unwell.||
1584|076|S|   This medication may cause you to become dehydrated. This can||
1584|077|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1584|078|S|dehydration. Tell your doctor or pharmacist right away if you are||
1584|079|S|not able to drink fluids as usual, or losing fluid (such as due||
1584|080|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1584|081|S|right away if you have any signs of dehydration, such as||
1584|082|S|urinating less than usual, unusual dry mouth/thirst, fast||
1584|083|S|heartbeat, or dizziness/lightheadedness/fainting.||
1584|084|S|   If you are taking dapagliflozin for diabetes, dapagliflozin||
1584|085|S|does not usually cause low blood sugar (hypoglycemia). Low blood||
1584|086|S|sugar may occur if this drug is prescribed with other diabetes||
1584|087|S|medications, or if you do not get enough calories from food, or||
1584|088|S|if you do unusually heavy exercise. Talk with your doctor or||
1584|089|S|pharmacist about whether the dose of your other diabetes||
1584|090|S|medication(s) needs to be lowered. Symptoms of low blood sugar||
1584|091|S|include sudden sweating, shaking, fast heartbeat, hunger, blurred||
1584|092|S|vision, dizziness, or tingling hands/feet. It is a good habit to||
1584|093|S|carry glucose tablets or gel to treat low blood sugar. If you||
1584|094|S|don't have these reliable forms of glucose, rapidly raise your||
1584|095|S|blood sugar by eating a quick source of sugar such as table||
1584|096|S|sugar, honey, or candy, or drink fruit juice or non-diet soda.||
1584|097|S|Tell your doctor right away about the reaction and the use of||
1584|098|S|this product. To help prevent low blood sugar, eat meals on a||
1584|099|S|regular schedule, and do not skip meals. Check with your doctor||
1584|100|S|or pharmacist to find out what you should do if you miss a meal.||
1584|101|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1584|102|S|thirst/urination. If these symptoms occur, tell your doctor right||
1584|103|S|away. Your doctor may need to adjust your diabetes medication,||
1584|104|S|exercise program, or diet.||
1584|105|S|   A very serious allergic reaction to this drug is rare.||
1584|106|S|However, get medical help right away if you notice any symptoms||
1584|107|S|of a serious allergic reaction, including: rash, itching/swelling||
1584|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1584|109|S|breathing.||
1584|110|S|   This is not a complete list of possible side effects. If you||
1584|111|S|notice other effects not listed above, contact your doctor or||
1584|112|S|pharmacist.||
1584|113|S|   In the US -||
1584|114|S|   Call your doctor for medical advice about side effects. You||
1584|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1584|116|S|www.fda.gov/medwatch.||
1584|117|S|   In Canada - Call your doctor for medical advice about side||
1584|118|S|effects. You may report side effects to Health Canada at||
1584|119|S|1-866-234-2345.||
1584|120|B|||
1584|121|P|PRECAUTIONS:  Before taking dapagliflozin, tell your doctor or||
1584|122|P|pharmacist if you are allergic to it; or if you have any other||
1584|123|P|allergies. This product may contain inactive ingredients, which||
1584|124|P|can cause allergic reactions or other problems. Talk to your||
1584|125|P|pharmacist for more details.||
1584|126|P|   Before using this medication, tell your doctor or pharmacist||
1584|127|P|your medical history, especially of: kidney disease/failure||
1584|128|P|(dialysis), disease of the pancreas (pancreatitis), dehydration,||
1584|129|P|use/abuse of alcohol, low blood pressure, history of yeast||
1584|130|P|infections in the vagina or penis.||
1584|131|P|   If you have diabetes, you may experience blurred vision,||
1584|132|P|dizziness, or drowsiness due to extremely low or high blood||
1584|133|P|sugar. Do not drive, use machinery, or do anything that needs||
1584|134|P|alertness until you can do it safely. Limit alcohol while taking||
1584|135|P|this medication because it can increase your risk of developing||
1584|136|P|low blood sugar and a high ketone level.||
1584|137|P|   If you have diabetes, it may be harder to control your blood||
1584|138|P|sugar when your body is stressed (such as due to fever,||
1584|139|P|infection, injury, or surgery). Also, if you are eating less or||
1584|140|P|not able to eat due to these conditions or any illness, this can||
1584|141|P|lead to a high ketone level while you are taking this medication.||
1584|142|P|Consult your doctor because this may require a change in your||
1584|143|P|treatment plan, medications, or blood sugar or ketone testing.||
1584|144|P|   Before having surgery, tell your doctor or dentist about all||
1584|145|P|the products you use (including prescription drugs,||
1584|146|P|nonprescription drugs, and herbal products).||
1584|147|P|   Older adults may be more sensitive to the side effects of this||
1584|148|P|drug, especially dizziness/fainting (usually when standing),||
1584|149|P|dehydration, and kidney disease.||
1584|150|P|   During pregnancy, this medication should be used only when||
1584|151|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1584|152|P|benefits with your doctor.||
1584|153|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1584|154|P|your doctor for managing your blood sugar while pregnant. Your||
1584|155|P|doctor may change your diabetes treatment during your pregnancy||
1584|156|P|(such as diet and medications including insulin).||
1584|157|P|   It is unknown if this drug passes into breast milk. Consult||
1584|158|P|your doctor before breastfeeding.||
1584|159|B|||
1584|160|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1584|161|I|medications work or increase your risk for serious side effects.||
1584|162|I|This document does not contain all possible drug interactions.||
1584|163|I|Keep a list of all the products you use (including||
1584|164|I|prescription/nonprescription drugs and herbal products) and share||
1584|165|I|it with your doctor and pharmacist. Do not start, stop, or change||
1584|166|I|the dosage of any medicines without your doctor's approval.||
1584|167|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1584|168|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1584|169|I|heartbeat you would usually feel when your blood sugar falls too||
1584|170|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1584|171|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1584|172|I|   Many drugs can affect blood sugar, making it harder to control||
1584|173|I|in people with diabetes. Before you start, stop, or change any||
1584|174|I|medication, talk with your doctor or pharmacist about how the||
1584|175|I|medication may affect your blood sugar if you have diabetes.||
1584|176|I|Check your blood sugar regularly as directed and share the||
1584|177|I|results with your doctor. Tell your doctor right away if you have||
1584|178|I|symptoms of high or low blood sugar. (See also Side Effects||
1584|179|I|section.) Your doctor may need to adjust your diabetes||
1584|180|I|medication, exercise program, or diet.||
1584|181|I|   This medication may interfere with certain lab tests (such as||
1584|182|I|urine glucose test), possibly causing false test results. Make||
1584|183|I|sure lab personnel and all your doctors know you use this drug.||
1584|184|B|||
1584|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1584|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1584|187|O|poison control center right away. US residents can call||
1584|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1584|189|B|||
1584|190|N|NOTES:  Do not share this medication with others.||
1584|191|N|   Lab and/or medical tests (such as kidney function, liver||
1584|192|N|function, blood sugar, hemoglobin A1c, complete blood counts,||
1584|193|N|cholesterol tests, ketones) may be done before you start taking||
1584|194|N|this medication and while you are taking it. Keep all medical and||
1584|195|N|lab appointments. Consult your doctor for more details.||
1584|196|N|   If you have diabetes, attend a diabetes education program to||
1584|197|N|learn more about how to manage your diabetes with medications,||
1584|198|N|diet, exercise, and regular medical exams. Learn the symptoms of||
1584|199|N|high and low blood sugar and how to treat low blood sugar. Check||
1584|200|N|your blood sugar regularly as directed.||
1584|201|B|||
1584|202|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1584|203|D|remember. If it is near the time of the next dose, skip the||
1584|204|D|missed dose. Take your next dose at the regular time. Do not||
1584|205|D|double the dose to catch up.||
1584|206|B|||
1584|207|R|STORAGE:  Store at room temperature away from light and moisture.||
1584|208|R|Do not store in the bathroom. Keep all medications away from||
1584|209|R|children and pets.||
1584|210|R|   Do not flush medications down the toilet or pour them into a||
1584|211|R|drain unless instructed to do so. Properly discard this product||
1584|212|R|when it is expired or no longer needed. Consult your pharmacist||
1584|213|R|or local waste disposal company.||
1584|214|B|||
1584|215|M|MEDICAL ALERT:  Your condition can cause complications in a||
1584|216|M|medical emergency. For information about enrolling in MedicAlert,||
1584|217|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1584|218|B|||
1584|219|A|Information last revised May 2025.||
1584|220|A|Copyright(c) 2025 First Databank, Inc.||
1584|221|B|||
1585|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1585|002|Z|does NOT have all possible information about this product. This||
1585|003|Z|information does not assure that this product is safe, effective,||
1585|004|Z|or appropriate for you. This information is not individual||
1585|005|Z|medical advice and does not substitute for the advice of your||
1585|006|Z|health care professional. Always ask your health care||
1585|007|Z|professional for complete information about this product and your||
1585|008|Z|specific health needs.||
1585|009|B|||
1585|010|T|CONJUGATED ESTROGENS/BAZEDOXIFENE - ORAL||
1585|011|F|(KON-joo-GAY-ted ES-troe-jens/BA-ze-DOX-i-feen)||
1585|012|B|||
1585|013|C|COMMON BRAND NAME(S): Duavee||
1585|014|B|||
1585|015|W|WARNING:  Women taking this product should not take additional||
1585|016|W|estrogens, progestins, or additional estrogen agonist/antagonists||
1585|017|W|(see also Drug Interactions section).||
1585|018|W|   Estrogens, either used alone or with another hormone||
1585|019|W|(progestin), have rarely caused very serious side effects.||
1585|020|W|Discuss the risks and benefits of hormone treatment with your||
1585|021|W|doctor. Estrogens should not be used to prevent heart disease or||
1585|022|W|dementia.||
1585|023|W|   Estrogens can increase the risk of cancer of the uterus||
1585|024|W|(endometrial cancer). The bazedoxifene in this product may help||
1585|025|W|decrease this risk. Tell your doctor right away if you have any||
1585|026|W|unusual vaginal bleeding.||
1585|027|W|   In postmenopausal women, estrogens, taken with or without a||
1585|028|W|progestin, increase the risk of cancer of the breast/ovaries,||
1585|029|W|stroke, dementia, and serious blood clots. When used along with a||
1585|030|W|progestin, estrogens also increase the risk of heart disease||
1585|031|W|(such as heart attacks).||
1585|032|W|   The risk for serious side effects may depend on the dose of||
1585|033|W|estrogen and the length of time it is used. This medication||
1585|034|W|should be used at the lowest effective dose and for the shortest||
1585|035|W|amount of time. Discuss the use of this medication with your||
1585|036|W|doctor and check with him/her regularly (for example, every 3 to||
1585|037|W|6 months) to see if you still need to take this medication. If||
1585|038|W|you will be taking this medication long-term, you should have||
1585|039|W|regular complete physical exams (for example, once a year) as||
1585|040|W|directed by your doctor. See also Notes section.||
1585|041|B|||
1585|042|U|USES:  This medication is a combination product containing||
1585|043|U|conjugated estrogens and bazedoxifene (an estrogen||
1585|044|U|agonist/antagonist). It is used by women with a uterus to help||
1585|045|U|reduce symptoms of menopause (such as hot flashes, vaginal||
1585|046|U|dryness) and to prevent bone loss (osteoporosis) after menopause.||
1585|047|U|Conjugated estrogens are hormones which help to decrease||
1585|048|U|menopausal symptoms caused by the body making less estrogen.||
1585|049|U|Bazedoxifene is not a hormone, but works by acting like estrogen||
1585|050|U|(as a selective estrogen receptor modulator or SERM) in some||
1585|051|U|parts of the body. The bazedoxifene in this medication helps to||
1585|052|U|preserve bone mass and reduces the risk of cancer of the uterus||
1585|053|U|which can be caused by using estrogen.||
1585|054|U|   If you are using this medication to treat symptoms only in and||
1585|055|U|around the vagina, consider using products applied directly||
1585|056|U|inside the vagina instead of medications that are taken by mouth,||
1585|057|U|absorbed through the skin, or injected.||
1585|058|B|||
1585|059|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1585|060|H|from your pharmacist before you start using this medication and||
1585|061|H|each time you get a refill. If you have any questions, ask your||
1585|062|H|doctor or pharmacist.||
1585|063|H|   Take this medication by mouth with or without food as directed||
1585|064|H|by your doctor, usually once daily. You may take it with food or||
1585|065|H|right after a meal to prevent stomach upset. Swallow the tablets||
1585|066|H|whole. Do not crush or chew the tablets. Doing so can release all||
1585|067|H|of the drug at once, increasing the risk of side effects.||
1585|068|H|   The dosage is based on your medical condition and response to||
1585|069|H|treatment.||
1585|070|H|   Take this medication regularly to get the most benefit from||
1585|071|H|it. To help you remember, take it at the same time each day. Do||
1585|072|H|not increase your dose or take this medication more often or for||
1585|073|H|a longer time than directed.||
1585|074|H|   Tell your doctor if your condition does not get better or if||
1585|075|H|it gets worse.||
1585|076|B|||
1585|077|S|SIDE EFFECTS:  See also Warning section.||
1585|078|S|   Stomach upset, nausea/vomiting, bloating, breast tenderness,||
1585|079|S|headache, or weight changes may occur. If any of these effects||
1585|080|S|last or get worse, tell your doctor or pharmacist promptly.||
1585|081|S|   Remember that this medication has been prescribed because your||
1585|082|S|doctor has judged that the benefit to you is greater than the||
1585|083|S|risk of side effects. Many people using this medication do not||
1585|084|S|have serious side effects.||
1585|085|S|   Tell your doctor right away if you have any serious side||
1585|086|S|effects, including: nausea/vomiting that doesn't stop, lumps in||
1585|087|S|the breast, mental/mood changes (such as depression, memory||
1585|088|S|loss), severe stomach/abdominal pain, yellowing eyes/skin, dark||
1585|089|S|urine, swelling hands/ankles/feet, increased thirst/urination,||
1585|090|S|unusual vaginal bleeding (such as spotting, sudden heavy||
1585|091|S|bleeding).||
1585|092|S|   This medication may raise your blood pressure. Check your||
1585|093|S|blood pressure regularly and tell your doctor if the results are||
1585|094|S|high.||
1585|095|S|   This medication may rarely cause serious problems from blood||
1585|096|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1585|097|S|legs). Get medical help right away if you have: chest/jaw/left||
1585|098|S|arm pain, confusion, pain/swelling/warmth in the groin/calf,||
1585|099|S|trouble speaking, sudden dizziness/fainting, sudden/severe||
1585|100|S|headaches, sudden vision changes, shortness of breath/rapid||
1585|101|S|breathing, unusual sweating, weakness on one side of the body.||
1585|102|S|   A very serious allergic reaction to this product is rare.||
1585|103|S|However, get medical help right away if you notice any symptoms||
1585|104|S|of a serious allergic reaction, including: rash, itching/swelling||
1585|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1585|106|S|breathing.||
1585|107|S|   This is not a complete list of possible side effects. If you||
1585|108|S|notice other effects not listed above, contact your doctor or||
1585|109|S|pharmacist.||
1585|110|S|   In the US -||
1585|111|S|   Call your doctor for medical advice about side effects. You||
1585|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1585|113|S|www.fda.gov/medwatch.||
1585|114|S|   In Canada - Call your doctor for medical advice about side||
1585|115|S|effects. You may report side effects to Health Canada at||
1585|116|S|1-866-234-2345.||
1585|117|B|||
1585|118|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1585|119|P|pharmacist if you are allergic to conjugated estrogens or||
1585|120|P|bazedoxifene; or if you have any other allergies. This product||
1585|121|P|may contain inactive ingredients, which can cause allergic||
1585|122|P|reactions or other problems. Talk to your pharmacist for more||
1585|123|P|details.||
1585|124|P|   Before using this medication, tell your doctor or pharmacist||
1585|125|P|your medical history, especially of: vaginal bleeding of unknown||
1585|126|P|cause, diabetes, cancer (especially breast cancer, cancer of the||
1585|127|P|uterus/ovaries), blood clots, blood clotting disorders (such as||
1585|128|P|protein C or protein S deficiency), family medical history||
1585|129|P|(especially of breast lumps, cancer, blood clots), family or||
1585|130|P|personal history of a certain swelling disorder (angioedema),||
1585|131|P|gallbladder disease, heart disease (such as irregular heartbeat,||
1585|132|P|previous heart attack), high blood pressure, high||
1585|133|P|cholesterol/triglyceride levels, kidney disease, liver disease,||
1585|134|P|lupus, mental/mood disorders (such as dementia, depression),||
1585|135|P|migraine headaches, underactive thyroid (hypothyroidism), mineral||
1585|136|P|imbalance (low or high level of calcium in the blood), obesity, a||
1585|137|P|certain hormone problem (hypoparathyroidism), uterus problems||
1585|138|P|(such as fibroids, endometriosis), asthma, seizures, stroke, a||
1585|139|P|certain blood disorder (porphyria).||
1585|140|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
1585|141|P|further increases your risk of stroke, blood clots, high blood||
1585|142|P|pressure, and heart attack, especially in women older than 35.||
1585|143|P|   Tell your doctor if you just had or will be having surgery, or||
1585|144|P|if you will be confined to a chair or bed for a long time (such||
1585|145|P|as a long plane flight). These conditions increase your risk of||
1585|146|P|getting blood clots, especially if you are taking an estrogen||
1585|147|P|product. You may need to stop this medication for a time or take||
1585|148|P|special precautions.||
1585|149|P|   Before having surgery, tell your doctor or dentist about all||
1585|150|P|the products you use (including prescription drugs,||
1585|151|P|nonprescription drugs, and herbal products).||
1585|152|P|   This medication may cause blotchy, dark areas on your face and||
1585|153|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
1585|154|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
1585|155|P|wear protective clothing when outdoors.||
1585|156|P|   If you are nearsighted or wear contact lenses, you may develop||
1585|157|P|vision problems or trouble wearing your contact lenses. Contact||
1585|158|P|your eye doctor if these problems occur.||
1585|159|P|   This medication must not be used during pregnancy. If you||
1585|160|P|become pregnant or think you may be pregnant, tell your doctor||
1585|161|P|right away.||
1585|162|P|   Estrogens pass into breast milk. It is unknown if bazedoxifene||
1585|163|P|passes into breast milk. Consult your doctor before||
1585|164|P|breastfeeding.||
1585|165|B|||
1585|166|I|DRUG INTERACTIONS:  See also Warning section.||
1585|167|I|   Drug interactions may change how your medications work or||
1585|168|I|increase your risk for serious side effects. This document does||
1585|169|I|not contain all possible drug interactions. Keep a list of all||
1585|170|I|the products you use (including prescription/nonprescription||
1585|171|I|drugs and herbal products) and share it with your doctor and||
1585|172|I|pharmacist. Do not start, stop, or change the dosage of any||
1585|173|I|medicines without your doctor's approval.||
1585|174|I|   Some products that may interact with this drug include:||
1585|175|I|aromatase inhibitors (such as anastrozole, exemestane,||
1585|176|I|letrozole), other estrogen agonist/antagonists (such as||
1585|177|I|ospemifene, raloxifene), fezolinetant, fulvestrant, tamoxifen,||
1585|178|I|tranexamic acid.||
1585|179|I|   This medication may interfere with certain lab tests (such as||
1585|180|I|metyrapone test, blood clotting tests, thyroid tests), possibly||
1585|181|I|causing false test results. Make sure lab personnel and all your||
1585|182|I|doctors know you use this drug.||
1585|183|B|||
1585|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1585|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1585|186|O|poison control center right away. US residents can call||
1585|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1585|188|O|Symptoms of overdose may include: severe nausea/vomiting, unusual||
1585|189|O|vaginal bleeding.||
1585|190|B|||
1585|191|N|NOTES:  Do not share this medication with others.||
1585|192|N|   Regular complete physical exams which include lab and/or||
1585|193|N|medical tests (such as blood pressure, breast exam/mammogram,||
1585|194|N|pelvic exam, Pap smear) should be done while you are taking this||
1585|195|N|medication. Follow your doctor's instructions for examining your||
1585|196|N|breasts, and report any lumps right away. Keep all medical and||
1585|197|N|lab appointments. Consult your doctor for more details.||
1585|198|N|   Preventing or controlling high blood pressure, high||
1585|199|N|cholesterol, and diabetes can help to reduce your chances of||
1585|200|N|heart disease and stroke. Lifestyle changes that can help to||
1585|201|N|control or prevent these diseases include reducing stress, eating||
1585|202|N|a low fat/salt diet, losing weight if overweight, exercising||
1585|203|N|regularly, and stopping smoking. Keep your mind active with||
1585|204|N|mental exercises (such as reading, solving crossword puzzles) to||
1585|205|N|help prevent dementia. Talk to your doctor about lifestyle||
1585|206|N|changes that might benefit you.||
1585|207|N|   Lifestyle changes that may help reduce hot flashes include||
1585|208|N|stopping smoking, dressing lightly or in layers,||
1585|209|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
1585|210|N|reducing stress, and exercising regularly.||
1585|211|N|   Lifestyle changes that help promote healthy bones include||
1585|212|N|increasing weight-bearing exercise, stopping smoking, limiting||
1585|213|N|alcohol, and eating well-balanced meals that contain adequate||
1585|214|N|calcium and vitamin D. Since you may also need to take calcium||
1585|215|N|and vitamin D supplements and make lifestyle changes, consult||
1585|216|N|your doctor for specific advice.||
1585|217|B|||
1585|218|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1585|219|D|remember. If it is near the time of the next dose, skip the||
1585|220|D|missed dose. Take your next dose at the regular time. Do not||
1585|221|D|double the dose to catch up.||
1585|222|B|||
1585|223|R|STORAGE:  Different brands of this medication have different||
1585|224|R|storage needs. Check the product package for instructions on how||
1585|225|R|to store your brand, or ask your pharmacist. Keep all medications||
1585|226|R|away from children and pets.||
1585|227|R|   Do not flush medications down the toilet or pour them into a||
1585|228|R|drain unless instructed to do so. Properly discard this product||
1585|229|R|when it is expired or no longer needed. Consult your pharmacist||
1585|230|R|or local waste disposal company.||
1585|231|B|||
1585|232|A|Information last revised February 2025.||
1585|233|A|Copyright(c) 2025 First Databank, Inc.||
1585|234|B|||
1586|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1586|002|Z|does NOT have all possible information about this product. This||
1586|003|Z|information does not assure that this product is safe, effective,||
1586|004|Z|or appropriate for you. This information is not individual||
1586|005|Z|medical advice and does not substitute for the advice of your||
1586|006|Z|health care professional. Always ask your health care||
1586|007|Z|professional for complete information about this product and your||
1586|008|Z|specific health needs.||
1586|009|B|||
1586|010|T|DICLOFENAC SOLUTION PUMP - TOPICAL||
1586|011|F|(dye-KLOE-fen-ak)||
1586|012|B|||
1586|013|C|COMMON BRAND NAME(S): Pennsaid||
1586|014|B|||
1586|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1586|016|W|diclofenac) may rarely increase the risk for a heart attack or||
1586|017|W|stroke. This effect can happen at any time while using this drug||
1586|018|W|but is more likely if you use it for a long time. The risk may be||
1586|019|W|greater in older adults or if you have heart disease or increased||
1586|020|W|risk for heart disease (for example, due to smoking, family||
1586|021|W|history of heart disease, or conditions such as high blood||
1586|022|W|pressure or diabetes). Do not use this drug right before or after||
1586|023|W|heart bypass surgery (CABG).||
1586|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
1586|025|W|bleeding from the stomach or intestines. This effect can occur||
1586|026|W|without warning symptoms at any time while using this drug. Older||
1586|027|W|adults may be at higher risk for this effect. (See also||
1586|028|W|Precautions and Drug Interactions sections.)||
1586|029|W|   Stop using diclofenac and get medical help right away if you||
1586|030|W|notice any of the following rare but very serious side effects:||
1586|031|W|stomach/abdominal pain that doesn't go away, black/bloody stools,||
1586|032|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1586|033|W|shortness of breath, unusual sweating, weakness on one side of||
1586|034|W|the body, sudden vision changes, trouble speaking.||
1586|035|W|   Talk with your doctor or pharmacist about the risks and||
1586|036|W|benefits of treatment with this medication.||
1586|037|B|||
1586|038|U|USES:  This medication is used to treat arthritis of the knee(s).||
1586|039|U|It reduces pain and swelling, and helps improve your ability to||
1586|040|U|move and flex the joint. Diclofenac is known as a nonsteroidal||
1586|041|U|anti-inflammatory drug (NSAID).||
1586|042|B|||
1586|043|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1586|044|H|Patient Information Leaflet provided by your pharmacist before||
1586|045|H|you start using diclofenac and each time you get a refill. If you||
1586|046|H|have any questions, ask your doctor or pharmacist.||
1586|047|H|   Before using the pump for the first time, remove the cap and||
1586|048|H|prime the pump as directed by the manufacturer.||
1586|049|H|   Apply this medication to clean, dry skin as directed by your||
1586|050|H|doctor, usually 2 times a day to the affected knee(s). Press down||
1586|051|H|firmly on the pump head 2 times and place the medication on the||
1586|052|H|palm of your hand. Apply the medication evenly around the front,||
1586|053|H|back, and sides of the knee. Repeat for the other knee if||
1586|054|H|directed to do so by your doctor. Let the medication dry for||
1586|055|H|several minutes. Do not wear clothing over it until the treated||
1586|056|H|knee is completely dry. Also, do not apply sunscreen, insect||
1586|057|H|repellant, lotion, or other topical products on your knee until||
1586|058|H|it is completely dry.||
1586|059|H|   Be sure to wash your hands before and after applying the||
1586|060|H|medication. Avoid getting this medication in the eyes, nose, or||
1586|061|H|mouth. Avoid showering/bathing for at least 30 minutes after||
1586|062|H|application. Do not apply to open wounds or to infected or||
1586|063|H|damaged skin. Do not wrap, bandage, or apply heat (such as a||
1586|064|H|heating pad) on the treated area unless you are instructed to do||
1586|065|H|so by your doctor.||
1586|066|H|   Use this medication regularly to get the most benefit from it.||
1586|067|H|Do not use more, apply it more often, or use it for a longer time||
1586|068|H|than prescribed.||
1586|069|H|   Tell your doctor if your condition does not get better or if||
1586|070|H|it gets worse.||
1586|071|B|||
1586|072|S|SIDE EFFECTS:  See also Warning section.||
1586|073|S|   Skin irritation such as dryness, flaking, redness, or itching||
1586|074|S|may occur. If any of these effects last or get worse, tell your||
1586|075|S|doctor or pharmacist promptly.||
1586|076|S|   Remember that this medication has been prescribed because your||
1586|077|S|doctor has judged that the benefit to you is greater than the||
1586|078|S|risk of side effects. Many people using this medication do not||
1586|079|S|have serious side effects.||
1586|080|S|   This medication may raise your blood pressure. Check your||
1586|081|S|blood pressure regularly and tell your doctor if the results are||
1586|082|S|high.||
1586|083|S|   Tell your doctor right away if you have any serious side||
1586|084|S|effects, including: signs of kidney problems (such as change in||
1586|085|S|the amount of urine), symptoms of heart failure (such as swelling||
1586|086|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
1586|087|S|   This drug may rarely cause serious (possibly fatal) liver||
1586|088|S|disease. Get medical help right away if you have any symptoms of||
1586|089|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1586|090|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
1586|091|S|eyes/skin.||
1586|092|S|   A very serious allergic reaction to this drug is rare.||
1586|093|S|However, get medical help right away if you notice any symptoms||
1586|094|S|of a serious allergic reaction, including: fever, swollen lymph||
1586|095|S|nodes, rash, itching/swelling (especially of the||
1586|096|S|face/tongue/throat), severe dizziness, trouble breathing.||
1586|097|S|   This is not a complete list of possible side effects. If you||
1586|098|S|notice other effects not listed above, contact your doctor or||
1586|099|S|pharmacist.||
1586|100|S|   In the US -||
1586|101|S|   Call your doctor for medical advice about side effects. You||
1586|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1586|103|S|www.fda.gov/medwatch.||
1586|104|S|   In Canada - Call your doctor for medical advice about side||
1586|105|S|effects. You may report side effects to Health Canada at||
1586|106|S|1-866-234-2345.||
1586|107|B|||
1586|108|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1586|109|P|pharmacist if you are allergic to it; or to aspirin or other||
1586|110|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
1586|111|P|any other allergies. This product may contain inactive||
1586|112|P|ingredients, which can cause allergic reactions or other||
1586|113|P|problems. Talk to your pharmacist for more details.||
1586|114|P|   Before using this medication, tell your doctor or pharmacist||
1586|115|P|your medical history, especially of: asthma (including a history||
1586|116|P|of worsening breathing with runny/stuffy nose after taking||
1586|117|P|aspirin or other NSAIDs), blood disorders (such as anemia,||
1586|118|P|bleeding/clotting problems), growths in the nose (nasal polyps),||
1586|119|P|heart disease (such as previous heart attack), high blood||
1586|120|P|pressure, liver disease, stomach/intestinal problems (such as||
1586|121|P|bleeding, ulcers), stroke.||
1586|122|P|   Kidney problems can sometimes occur with the use of NSAID||
1586|123|P|medications, including diclofenac. Problems are more likely to||
1586|124|P|occur if you are dehydrated, have heart failure or kidney||
1586|125|P|disease, are an older adult, or if you take certain medications||
1586|126|P|(see also Drug Interactions section). Drink plenty of fluids as||
1586|127|P|directed by your doctor to prevent dehydration and tell your||
1586|128|P|doctor right away if you have a change in the amount of urine.||
1586|129|P|   Before having surgery, tell your doctor or dentist about all||
1586|130|P|the products you use (including prescription drugs,||
1586|131|P|nonprescription drugs, and herbal products).||
1586|132|P|   This medication may cause stomach bleeding. Daily use of||
1586|133|P|alcohol and tobacco, especially when combined with this medicine,||
1586|134|P|may increase your risk for stomach bleeding. Limit alcohol and||
1586|135|P|stop smoking. Consult your doctor or pharmacist for more||
1586|136|P|information.||
1586|137|P|   This medication may make you more sensitive to the sun. Limit||
1586|138|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1586|139|P|sunscreen and wear protective clothing when outdoors. Tell your||
1586|140|P|doctor right away if you get sunburned or have skin||
1586|141|P|blisters/redness.||
1586|142|P|   Older adults may be at greater risk for stomach/intestinal||
1586|143|P|bleeding, kidney problems, heart attack, and stroke while using||
1586|144|P|this drug.||
1586|145|P|   Before using this medication, women of childbearing age should||
1586|146|P|talk with their doctor(s) about the benefits and risks. Tell your||
1586|147|P|doctor if you are pregnant or if you plan to become pregnant.||
1586|148|P|This medication may harm an unborn baby and cause problems with||
1586|149|P|normal labor/delivery. It is not recommended for use in pregnancy||
1586|150|P|from 20 weeks until delivery. If your doctor decides that you||
1586|151|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1586|152|P|you should use the lowest effective dose for the shortest||
1586|153|P|possible time. You should not use this medication after 30 weeks||
1586|154|P|of pregnancy.||
1586|155|P|   It is unknown if this form of diclofenac passes into breast||
1586|156|P|milk. Consult your doctor before breastfeeding.||
1586|157|B|||
1586|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1586|159|I|medications work or increase your risk for serious side effects.||
1586|160|I|This document does not contain all possible drug interactions.||
1586|161|I|Keep a list of all the products you use (including||
1586|162|I|prescription/nonprescription drugs and herbal products) and share||
1586|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
1586|164|I|the dosage of any medicines without your doctor's approval.||
1586|165|I|   Some products that may interact with this drug include:||
1586|166|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1586|167|I|angiotensin II receptor blockers (such as losartan, valsartan),||
1586|168|I|cidofovir, corticosteroids (such as prednisone), lithium,||
1586|169|I|methotrexate, "water pills" (diuretics such as furosemide).||
1586|170|I|   This medication may increase the risk of bleeding when used||
1586|171|I|with other drugs that also may cause bleeding. Examples include||
1586|172|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1586|173|I|dabigatran/enoxaparin/warfarin, among others.||
1586|174|I|   Check all prescription and nonprescription medicine labels||
1586|175|I|carefully since many medications contain pain relievers/fever||
1586|176|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac, or||
1586|177|I|naproxen). These drugs are similar to diclofenac and may increase||
1586|178|I|your risk of side effects if taken together. However, if your||
1586|179|I|doctor has told you to take low-dose aspirin to prevent heart||
1586|180|I|attack or stroke (usually 81-162 milligrams a day), you should||
1586|181|I|keep taking the aspirin unless your doctor tells you not to. Ask||
1586|182|I|your doctor or pharmacist for more details.||
1586|183|B|||
1586|184|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1586|185|O|has overdosed and has serious symptoms such as passing out or||
1586|186|O|trouble breathing, call 911. Otherwise, call a poison control||
1586|187|O|center right away. US residents can call 1-800-222-1222. Canada||
1586|188|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1586|189|O|include: severe stomach pain, vomit that looks like coffee||
1586|190|O|grounds.||
1586|191|B|||
1586|192|N|NOTES:  Do not share this medication with others.||
1586|193|N|   Lab and/or medical tests (such as blood pressure, complete||
1586|194|N|blood count, kidney/liver function) should be done while you are||
1586|195|N|using this medication. Keep all medical and lab appointments.||
1586|196|N|Consult your doctor for more details.||
1586|197|N|   Non-drug treatment for arthritis that is approved by your||
1586|198|N|doctor (such as weight loss if needed, strengthening and||
1586|199|N|conditioning exercises) may help improve your flexibility and||
1586|200|N|joint function. Consult your doctor for specific instructions.||
1586|201|B|||
1586|202|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1586|203|D|If it is near the time of the next dose, skip the missed dose.||
1586|204|D|Use your next dose at the regular time. Do not double the dose to||
1586|205|D|catch up.||
1586|206|B|||
1586|207|R|STORAGE:  Store at room temperature. Keep all medications away||
1586|208|R|from children and pets.||
1586|209|R|   Do not flush medications down the toilet or pour them into a||
1586|210|R|drain unless instructed to do so. Properly discard this product||
1586|211|R|when it is expired or no longer needed. Consult your pharmacist||
1586|212|R|or local waste disposal company.||
1586|213|B|||
1586|214|A|Information last revised October 2024.||
1586|215|A|Copyright(c) 2025 First Databank, Inc.||
1586|216|B|||
1587|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1587|002|Z|does NOT have all possible information about this product. This||
1587|003|Z|information does not assure that this product is safe, effective,||
1587|004|Z|or appropriate for you. This information is not individual||
1587|005|Z|medical advice and does not substitute for the advice of your||
1587|006|Z|health care professional. Always ask your health care||
1587|007|Z|professional for complete information about this product and your||
1587|008|Z|specific health needs.||
1587|009|B|||
1587|010|T|IOHEXOL LIQUID - INJECTION||
1587|011|F|(EYE-oh-HEX-ol)||
1587|012|B|||
1587|013|C|COMMON BRAND NAME(S): Omnipaque||
1587|014|B|||
1587|015|U|USES:  This medication is used before X-ray imaging tests (such||
1587|016|U|as CT scans). Iohexol contains iodine and belongs to a class of||
1587|017|U|drugs known as contrast media or dyes. It works by adding||
1587|018|U|contrast to body parts and fluids in these imaging tests. Iohexol||
1587|019|U|improves the images obtained during a CT scan, so your doctor can||
1587|020|U|more easily diagnose your condition.||
1587|021|B|||
1587|022|H|HOW TO USE:  If your doctor directs you to take this medication||
1587|023|H|by mouth, read your doctor's specific instructions on when and||
1587|024|H|how to take iohexol before your imaging test. To make it easier||
1587|025|H|to swallow, this medication can be mixed with water, carbonated||
1587|026|H|beverages, milk, or juice. Your doctor or pharmacist should tell||
1587|027|H|you the amount of iohexol to use and how much liquid to dilute it||
1587|028|H|in.||
1587|029|H|   Take this medication by mouth as directed by your doctor. It||
1587|030|H|is usually taken just before the imaging test. The dosage is||
1587|031|H|based on the specific imaging test, your age, and your weight.||
1587|032|H|   Drink plenty of fluids before and after the imaging test,||
1587|033|H|unless directed otherwise by your doctor.||
1587|034|H|   This medication may also be given by a health care||
1587|035|H|professional by injection into a vein, joint, the spine, or||
1587|036|H|placed in the bladder or the rectum. If given these ways, there||
1587|037|H|are different precautions and side effects to be aware of. Talk||
1587|038|H|to your doctor or pharmacist for more details.||
1587|039|B|||
1587|040|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, stomach pain, gas, or||
1587|041|S|headache may occur. If any of these effects last or get worse,||
1587|042|S|tell your doctor or pharmacist promptly.||
1587|043|S|   Remember that this medication has been prescribed because your||
1587|044|S|doctor has judged that the benefit to you is greater than the||
1587|045|S|risk of side effects. Many people using this medication do not||
1587|046|S|have serious side effects.||
1587|047|S|   Tell your doctor right away if you have any serious side||
1587|048|S|effects, including: signs of kidney problems (such as change in||
1587|049|S|the amount of urine).||
1587|050|S|   A very serious allergic reaction to this drug is rare.||
1587|051|S|However, get medical help right away if you notice any symptoms||
1587|052|S|of a serious allergic reaction, including: rash, itching/swelling||
1587|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1587|054|S|breathing.||
1587|055|S|   This is not a complete list of possible side effects. If you||
1587|056|S|notice other effects not listed above, contact your doctor or||
1587|057|S|pharmacist.||
1587|058|S|   In the US -||
1587|059|S|   Call your doctor for medical advice about side effects. You||
1587|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1587|061|S|www.fda.gov/medwatch.||
1587|062|S|   In Canada - Call your doctor for medical advice about side||
1587|063|S|effects. You may report side effects to Health Canada at||
1587|064|S|1-866-234-2345.||
1587|065|B|||
1587|066|P|PRECAUTIONS:  Before taking iohexol, tell your doctor or||
1587|067|P|pharmacist if you are allergic to it; to other contrast media; or||
1587|068|P|to iodine; or if you have any other allergies. This product may||
1587|069|P|contain inactive ingredients, which can cause allergic reactions||
1587|070|P|or other problems. Talk to your pharmacist for more details.||
1587|071|P|   Before using this medication, tell your doctor or pharmacist||
1587|072|P|your medical history, especially of: asthma, hay fever, kidney||
1587|073|P|disease.||
1587|074|P|   Before having surgery, tell your doctor or dentist about all||
1587|075|P|the products you use (including prescription drugs,||
1587|076|P|nonprescription drugs, and herbal products).||
1587|077|P|   During pregnancy, this medication should be used only when||
1587|078|P|clearly needed. Discuss the risks and benefits with your doctor.||
1587|079|P|   When taken by mouth, this medication is unlikely to pass into||
1587|080|P|breast milk. Consult your doctor before breastfeeding.||
1587|081|B|||
1587|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1587|083|I|medications work or increase your risk for serious side effects.||
1587|084|I|This document does not contain all possible drug interactions.||
1587|085|I|Keep a list of all the products you use (including||
1587|086|I|prescription/nonprescription drugs and herbal products) and share||
1587|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
1587|088|I|the dosage of any medicines without your doctor's approval.||
1587|089|I|   One product that may interact with this drug is: metformin.||
1587|090|I|   This medication may interfere with certain lab tests (such as||
1587|091|I|protein-bound iodine test), possibly causing false test results.||
1587|092|I|Make sure lab personnel and all your doctors know you use this||
1587|093|I|drug.||
1587|094|B|||
1587|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1587|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1587|097|O|poison control center right away. US residents can call||
1587|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1587|099|B|||
1587|100|N|NOTES:  Do not share this medication with others.||
1587|101|B|||
1587|102|D|MISSED DOSE:  Not applicable. This medication is given once||
1587|103|D|before your imaging test. It is important to take this medication||
1587|104|D|at the time prescribed by your doctor. If you forget to take the||
1587|105|D|dose, your imaging test may need to be rescheduled.||
1587|106|B|||
1587|107|R|STORAGE:  Store at room temperature away from light. Do not||
1587|108|R|freeze. Keep all medications away from children and pets.||
1587|109|R|   Do not flush medications down the toilet or pour them into a||
1587|110|R|drain unless instructed to do so. Properly discard this product||
1587|111|R|when it is expired or no longer needed. Consult your pharmacist||
1587|112|R|or local waste disposal company.||
1587|113|B|||
1587|114|A|Information last revised October 2024.||
1587|115|A|Copyright(c) 2025 First Databank, Inc.||
1587|116|B|||
1588|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1588|002|Z|does NOT have all possible information about this product. This||
1588|003|Z|information does not assure that this product is safe, effective,||
1588|004|Z|or appropriate for you. This information is not individual||
1588|005|Z|medical advice and does not substitute for the advice of your||
1588|006|Z|health care professional. Always ask your health care||
1588|007|Z|professional for complete information about this product and your||
1588|008|Z|specific health needs.||
1588|009|B|||
1588|010|T|HYDROCODONE EXTENDED-RELEASE CAPSULE - ORAL||
1588|011|F|(HYE-droe-KOE-done)||
1588|012|B|||
1588|013|C|COMMON BRAND NAME(S): Zohydro ER||
1588|014|B|||
1588|015|W|WARNING:  Hydrocodone has a risk for abuse and addiction, which||
1588|016|W|can lead to overdose and death. Hydrocodone may also cause||
1588|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
1588|018|W|your doctor should have you take the smallest dose of hydrocodone||
1588|019|W|that works, and take it for the shortest possible time. See also||
1588|020|W|How to Use section for more information about addiction.||
1588|021|W|   Ask your doctor or pharmacist if you should have medication||
1588|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1588|023|W|Teach your family or household members about the signs of an||
1588|024|W|opioid overdose and how to treat it.||
1588|025|W|   The risk for severe breathing problems is higher when you||
1588|026|W|start this medication and after a dose increase, or if you take||
1588|027|W|the wrong dose/strength. Taking this medication with alcohol or||
1588|028|W|other drugs that can cause drowsiness or breathing problems may||
1588|029|W|cause very serious side effects, including death. Also, other||
1588|030|W|medications can affect the removal of hydrocodone from your body,||
1588|031|W|which may affect how hydrocodone works. Be sure you know how to||
1588|032|W|take hydrocodone and what other drugs you should avoid taking||
1588|033|W|with it. See also Drug Interactions section. Get medical help||
1588|034|W|right away if any of these very serious side effects occur:||
1588|035|W|slow/shallow breathing, unusual lightheadedness, severe||
1588|036|W|drowsiness/dizziness, difficulty waking up.||
1588|037|W|   Do not crush, chew, or dissolve this medication or the||
1588|038|W|contents of the capsules. Also, do not drink alcohol or use any||
1588|039|W|product that contains alcohol while taking this medication.||
1588|040|W|Drinking alcohol with this medication or taking crushed, chewed,||
1588|041|W|or dissolved forms of extended-release hydrocodone could cause a||
1588|042|W|fatal overdose.||
1588|043|W|   Before using this medication, women of childbearing age should||
1588|044|W|talk with their doctor(s) about the risks and benefits. Tell your||
1588|045|W|doctor if you are pregnant or if you plan to become pregnant.||
1588|046|W|During pregnancy, this medication should be used only when||
1588|047|W|clearly needed. It may slightly increase the risk of birth||
1588|048|W|defects if used during the first two months of pregnancy. Also,||
1588|049|W|using it for a long time or in high doses near the expected||
1588|050|W|delivery date may harm the unborn baby. To lessen the risk, take||
1588|051|W|the smallest effective dose for the shortest possible time.||
1588|052|W|Babies born to mothers who use this drug for a long time may||
1588|053|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1588|054|W|doctor right away if you notice any symptoms in your newborn baby||
1588|055|W|such as nonstop crying, slow/shallow breathing, irritability,||
1588|056|W|shaking, vomiting, diarrhea, poor feeding, or difficulty gaining||
1588|057|W|weight.||
1588|058|W|   Keep this medication in a safe place to prevent theft, misuse,||
1588|059|W|or abuse. If someone accidentally swallows this drug, get medical||
1588|060|W|help right away.||
1588|061|B|||
1588|062|U|USES:  Hydrocodone is used to help relieve severe ongoing pain.||
1588|063|U|Hydrocodone belongs to a class of drugs known as opioid||
1588|064|U|analgesics. It works in the brain to change how your body feels||
1588|065|U|and responds to pain.||
1588|066|U|   Do not use the extended-release form of hydrocodone to relieve||
1588|067|U|pain that is mild or that will go away in a few days. This||
1588|068|U|medication is not for occasional ("as needed") use.||
1588|069|B|||
1588|070|H|HOW TO USE:  See also Warning section.||
1588|071|H|   Read the Medication Guide and, if available, the Patient||
1588|072|H|Information Leaflet provided by your pharmacist before you start||
1588|073|H|taking hydrocodone and each time you get a refill. If you have||
1588|074|H|any questions, ask your doctor or pharmacist.||
1588|075|H|   Take this medication on a regular schedule as directed by your||
1588|076|H|doctor, not as needed for sudden (breakthrough) pain. Take this||
1588|077|H|medication by mouth as directed by your doctor, usually every 12||
1588|078|H|hours. You may take this drug with or without food. If you have||
1588|079|H|nausea, it may help to take this drug with food. Ask your doctor||
1588|080|H|or pharmacist about other ways to decrease nausea (such as lying||
1588|081|H|down for 1 to 2 hours with as little head movement as possible).||
1588|082|H|   Swallow the capsules whole. Do not crush, chew, or dissolve||
1588|083|H|the capsules. Doing so can release all of the drug at once,||
1588|084|H|increasing the risk of side effects.||
1588|085|H|   The dosage is based on your medical condition and response to||
1588|086|H|treatment. Do not increase your dose or use this drug more often||
1588|087|H|or for longer than prescribed. Your condition will not improve||
1588|088|H|any faster, and your risk of side effects will increase. Properly||
1588|089|H|stop the medication when so directed.||
1588|090|H|   Pain medications work best if they are used as the first signs||
1588|091|H|of pain occur. If you wait until the pain has worsened, the||
1588|092|H|medication may not work as well.||
1588|093|H|   Before you start using this medication, ask your doctor or||
1588|094|H|pharmacist if you should stop or change how you use your other||
1588|095|H|opioid medication(s). Other pain relievers (such as||
1588|096|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1588|097|H|or pharmacist about using hydrocodone safely with other drugs.||
1588|098|H|   Suddenly stopping this medication may cause withdrawal,||
1588|099|H|especially if you have used it for a long time or in high doses.||
1588|100|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1588|101|H|Tell your doctor or pharmacist right away if you have any||
1588|102|H|withdrawal symptoms such as restlessness, mental/mood changes||
1588|103|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1588|104|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1588|105|H|aches, or sudden changes in behavior.||
1588|106|H|   When this medication is used for a long time, it may not work||
1588|107|H|as well. Talk with your doctor if this medication stops working||
1588|108|H|well.||
1588|109|H|   Though it helps many people, this medication may sometimes||
1588|110|H|cause addiction. This risk may be higher if you have a||
1588|111|H|mental/mood disorder or a substance use disorder (such as overuse||
1588|112|H|of or addiction to drugs/alcohol). Take this medication exactly||
1588|113|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1588|114|H|pharmacist for more details.||
1588|115|H|   Tell your doctor if your pain does not get better or if it||
1588|116|H|gets worse, or if you have any new pain.||
1588|117|B|||
1588|118|S|SIDE EFFECTS:  See also Warning section.||
1588|119|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
1588|120|S|drowsiness may occur. Some of these side effects may decrease||
1588|121|S|after you have been using this medication for a while. If any of||
1588|122|S|these effects last or get worse, tell your doctor or pharmacist||
1588|123|S|promptly.||
1588|124|S|   To prevent constipation, eat dietary fiber, drink enough||
1588|125|S|water, and exercise. You may also need to take a laxative. Ask||
1588|126|S|your pharmacist which type of laxative is right for you.||
1588|127|S|   To reduce the risk of dizziness and lightheadedness, get up||
1588|128|S|slowly when rising from a sitting or lying position.||
1588|129|S|   Remember that this medication has been prescribed because your||
1588|130|S|doctor has judged that the benefit to you is greater than the||
1588|131|S|risk of side effects. Many people using this medication do not||
1588|132|S|have serious side effects.||
1588|133|S|   Tell your doctor right away if you have any serious side||
1588|134|S|effects, including: interrupted breathing during sleep (sleep||
1588|135|S|apnea), mental/mood changes (such as agitation, confusion,||
1588|136|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
1588|137|S|signs of your adrenal glands not working well (such as loss of||
1588|138|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
1588|139|S|   Get medical help right away if you have any very serious side||
1588|140|S|effects, including: fainting, fast/irregular heartbeat, severe||
1588|141|S|dizziness, seizure, slow/shallow breathing, severe||
1588|142|S|drowsiness/difficulty waking up.||
1588|143|S|   A very serious allergic reaction to this drug is rare.||
1588|144|S|However, get medical help right away if you notice any symptoms||
1588|145|S|of a serious allergic reaction, including: rash, itching/swelling||
1588|146|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1588|147|S|breathing.||
1588|148|S|   This is not a complete list of possible side effects. If you||
1588|149|S|notice other effects not listed above, contact your doctor or||
1588|150|S|pharmacist.||
1588|151|S|   In the US -||
1588|152|S|   Call your doctor for medical advice about side effects. You||
1588|153|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1588|154|S|www.fda.gov/medwatch.||
1588|155|S|   In Canada - Call your doctor for medical advice about side||
1588|156|S|effects. You may report side effects to Health Canada at||
1588|157|S|1-866-234-2345.||
1588|158|B|||
1588|159|P|PRECAUTIONS:  Before taking hydrocodone, tell your doctor or||
1588|160|P|pharmacist if you are allergic to it; or to other opioids (such||
1588|161|P|as benzhydrocodone, codeine, hydromorphone); or if you have any||
1588|162|P|other allergies. This product may contain inactive ingredients,||
1588|163|P|which can cause allergic reactions or other problems. Talk to||
1588|164|P|your pharmacist for more details.||
1588|165|P|   Before using this medication, tell your doctor or pharmacist||
1588|166|P|your medical history, especially of: brain disorders (such as||
1588|167|P|head injury, tumor, seizures), breathing problems (such as||
1588|168|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1588|169|P|gallbladder disease, kidney disease, liver disease, mental/mood||
1588|170|P|disorders (such as confusion, depression, thoughts of suicide),||
1588|171|P|personal or family history of a substance use disorder (such as||
1588|172|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
1588|173|P|problems (such as blockage, constipation, diarrhea due to||
1588|174|P|infection, paralytic ileus), disease of the pancreas||
1588|175|P|(pancreatitis), difficulty urinating (such as due to enlarged||
1588|176|P|prostate).||
1588|177|P|   Hydrocodone may cause a condition that affects the heart||
1588|178|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1588|179|P|serious (rarely fatal) fast/irregular heartbeat and other||
1588|180|P|symptoms (such as severe dizziness, fainting) that need medical||
1588|181|P|attention right away.||
1588|182|P|   The risk of QT prolongation may be increased if you have||
1588|183|P|certain medical conditions or are taking other drugs that may||
1588|184|P|cause QT prolongation. Before using hydrocodone, tell your doctor||
1588|185|P|or pharmacist of all the drugs you take and if you have any of||
1588|186|P|the following conditions: certain heart problems (heart failure,||
1588|187|P|slow heartbeat, QT prolongation in the EKG), family history of||
1588|188|P|certain heart problems (QT prolongation in the EKG, sudden||
1588|189|P|cardiac death).||
1588|190|P|   Low levels of potassium or magnesium in the blood may also||
1588|191|P|increase your risk of QT prolongation. This risk may increase if||
1588|192|P|you use certain drugs (such as diuretics/"water pills") or if you||
1588|193|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1588|194|P|Talk to your doctor about using hydrocodone safely.||
1588|195|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1588|196|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1588|197|P|machinery, or do anything that needs alertness until you can do||
1588|198|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1588|199|P|are using marijuana (cannabis).||
1588|200|P|   Before having surgery, tell your doctor or dentist about all||
1588|201|P|the products you use (including prescription drugs,||
1588|202|P|nonprescription drugs, and herbal products).||
1588|203|P|   Children may be more sensitive to the side effects of this||
1588|204|P|drug, especially slow/shallow breathing.||
1588|205|P|   Older adults may be more sensitive to the side effects of this||
1588|206|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
1588|207|P|breathing, QT prolongation (see above).||
1588|208|P|   During pregnancy, this medication should be used only when||
1588|209|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1588|210|P|benefits with your doctor. (See also Warning section.)||
1588|211|P|   This drug passes into breast milk and may have undesirable||
1588|212|P|effects on a nursing infant. Tell the doctor right away if your||
1588|213|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1588|214|P|breathing. Consult your doctor before breastfeeding.||
1588|215|B|||
1588|216|I|DRUG INTERACTIONS:  See also Warning section.||
1588|217|I|   Drug interactions may change how your medications work or||
1588|218|I|increase your risk for serious side effects. This document does||
1588|219|I|not contain all possible drug interactions. Keep a list of all||
1588|220|I|the products you use (including prescription/nonprescription||
1588|221|I|drugs and herbal products) and share it with your doctor and||
1588|222|I|pharmacist. Do not start, stop, or change the dosage of any||
1588|223|I|medicines without your doctor's approval.||
1588|224|I|   Some products that may interact with this drug include:||
1588|225|I|certain pain medications (mixed opioid agonist-antagonists such||
1588|226|I|as butorphanol, nalbuphine, pentazocine), naltrexone, products||
1588|227|I|that contain alcohol (such as cough-and-cold syrups),||
1588|228|I|samidorphan.||
1588|229|I|   Other medications can affect the removal of hydrocodone from||
1588|230|I|your body, which may affect how hydrocodone works. Examples||
1588|231|I|include azole antifungals (such as ketoconazole), macrolide||
1588|232|I|antibiotics (such as erythromycin), mifepristone, HIV medications||
1588|233|I|(such as tipranavir), rifamycins (such as rifabutin, rifampin),||
1588|234|I|ritonavir, certain drugs used to treat seizures (such as||
1588|235|I|carbamazepine, phenytoin), among others.||
1588|236|I|   The risk of serious side effects (such as slow/shallow||
1588|237|I|breathing, severe drowsiness/dizziness) may be increased if this||
1588|238|I|medication is taken with other products that may also cause||
1588|239|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1588|240|I|if you are taking other products such as other opioid pain or||
1588|241|I|cough relievers (such as codeine, oxycodone), alcohol, marijuana||
1588|242|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1588|243|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1588|244|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1588|245|I|diphenhydramine).||
1588|246|I|   Check the labels on all your medicines (such as allergy or||
1588|247|I|cough-and-cold products) because they may contain ingredients||
1588|248|I|that cause drowsiness. Ask your pharmacist about using those||
1588|249|I|products safely.||
1588|250|I|   This medication may interfere with certain lab tests (such as||
1588|251|I|amylase/lipase levels), possibly causing false test results. Make||
1588|252|I|sure lab personnel and all your doctors know you use this drug.||
1588|253|B|||
1588|254|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1588|255|O|as passing out or trouble breathing, give them naloxone or||
1588|256|O|nalmefene if available, then call 911. If the person is awake and||
1588|257|O|has no symptoms, call a poison control center right away. US||
1588|258|O|residents can call 1-800-222-1222. Canada residents can call||
1588|259|O|1-844-764-7669. Symptoms of overdose may include: slow breathing,||
1588|260|O|slow heartbeat, coma.||
1588|261|B|||
1588|262|N|NOTES:  Do not share this medication with others. Sharing it is||
1588|263|N|against the law.||
1588|264|N|   This medication has been prescribed for your current condition||
1588|265|N|only. Do not use it later for another condition unless your||
1588|266|N|doctor directs you to do so. A different medication may be||
1588|267|N|necessary in that case.||
1588|268|B|||
1588|269|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1588|270|D|remember. If it is near the time of the next dose, skip the||
1588|271|D|missed dose. Take your next dose at the regular time. Do not||
1588|272|D|double the dose to catch up.||
1588|273|B|||
1588|274|R|STORAGE:  Store at room temperature away from light and moisture.||
1588|275|R|Do not store in the bathroom. Keep all medications away from||
1588|276|R|children and pets. See also Warning section.||
1588|277|R|   Do not flush medications down the toilet or pour them into a||
1588|278|R|drain unless instructed to do so. Properly discard this product||
1588|279|R|when it is expired or no longer needed. For more details, read||
1588|280|R|the Medication Guide, or consult your pharmacist or local waste||
1588|281|R|disposal company.||
1588|282|B|||
1588|283|A|Information last revised August 2025.||
1588|284|A|Copyright(c) 2025 First Databank, Inc.||
1588|285|B|||
1590|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1590|002|Z|does NOT have all possible information about this product. This||
1590|003|Z|information does not assure that this product is safe, effective,||
1590|004|Z|or appropriate for you. This information is not individual||
1590|005|Z|medical advice and does not substitute for the advice of your||
1590|006|Z|health care professional. Always ask your health care||
1590|007|Z|professional for complete information about this product and your||
1590|008|Z|specific health needs.||
1590|009|B|||
1590|010|T|LULICONAZOLE - TOPICAL||
1590|011|F|(LOO-li-KON-a-zole)||
1590|012|B|||
1590|013|C|COMMON BRAND NAME(S): Luzu||
1590|014|B|||
1590|015|U|USES:  Luliconazole is used to treat skin infections such as||
1590|016|U|athlete's foot, jock itch, and ringworm. Luliconazole is an azole||
1590|017|U|antifungal that works by preventing the growth of the fungus.||
1590|018|B|||
1590|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1590|020|H|from your pharmacist before you start using luliconazole and each||
1590|021|H|time you get a refill. If you have any questions, ask your doctor||
1590|022|H|or pharmacist.||
1590|023|H|   This medication is for use on the skin only.||
1590|024|H|   Wash and dry your hands before applying the medication, then||
1590|025|H|clean and dry the affected area. Apply a thin film of the||
1590|026|H|medication to the affected area and some of the surrounding skin||
1590|027|H|and gently rub in as directed by your doctor, usually once a day.||
1590|028|H|The length of treatment depends on the type of infection being||
1590|029|H|treated. Do not apply this more often than prescribed. Your||
1590|030|H|condition will not clear faster, and your risk of side effects||
1590|031|H|will increase.||
1590|032|H|   After applying the medication, wash your hands. Do not cover,||
1590|033|H|bandage, or wrap the area unless directed to do so by your||
1590|034|H|doctor.||
1590|035|H|   Do not apply this medication in the eyes, mouth, or vagina.||
1590|036|H|   Use this medication regularly to get the most benefit from it.||
1590|037|H|To help you remember, use it at the same time each day.||
1590|038|H|   Continue to use this medication until the full prescribed||
1590|039|H|amount is finished, even if symptoms disappear after a few days.||
1590|040|H|Stopping the medication too early may result in a return of the||
1590|041|H|infection.||
1590|042|H|   Tell your doctor if your condition lasts or gets worse.||
1590|043|B|||
1590|044|S|SIDE EFFECTS:  Skin irritation may occur. If it lasts or gets||
1590|045|S|worse, tell your doctor or pharmacist promptly.||
1590|046|S|   Remember that this medication has been prescribed because your||
1590|047|S|doctor has judged that the benefit to you is greater than the||
1590|048|S|risk of side effects. Many people using this medication do not||
1590|049|S|have serious side effects.||
1590|050|S|   A very serious allergic reaction to this drug is rare.||
1590|051|S|However, get medical help right away if you notice any symptoms||
1590|052|S|of a serious allergic reaction, including: rash, itching/swelling||
1590|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1590|054|S|breathing.||
1590|055|S|   This is not a complete list of possible side effects. If you||
1590|056|S|notice other effects not listed above, contact your doctor or||
1590|057|S|pharmacist.||
1590|058|S|   In the US -||
1590|059|S|   Call your doctor for medical advice about side effects. You||
1590|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1590|061|S|www.fda.gov/medwatch.||
1590|062|S|   In Canada - Call your doctor for medical advice about side||
1590|063|S|effects. You may report side effects to Health Canada at||
1590|064|S|1-866-234-2345.||
1590|065|B|||
1590|066|P|PRECAUTIONS:  Before taking luliconazole, tell your doctor or||
1590|067|P|pharmacist if you are allergic to it; or to other azole||
1590|068|P|antifungals such as econazole, ketoconazole, or miconazole; or if||
1590|069|P|you have any other allergies. This product may contain inactive||
1590|070|P|ingredients, which can cause allergic reactions or other||
1590|071|P|problems. Talk to your pharmacist for more details.||
1590|072|P|   Before using this medication, tell your doctor or pharmacist||
1590|073|P|your medical history.||
1590|074|P|   Before having surgery, tell your doctor or dentist about all||
1590|075|P|the products you use (including prescription drugs,||
1590|076|P|nonprescription drugs, and herbal products).||
1590|077|P|   During pregnancy, this medication should be used only when||
1590|078|P|clearly needed. Discuss the risks and benefits with your doctor.||
1590|079|P|   It is unknown if this medication passes into breast milk.||
1590|080|P|Consult your doctor before breastfeeding.||
1590|081|B|||
1590|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1590|083|I|medications work or increase your risk for serious side effects.||
1590|084|I|This document does not contain all possible drug interactions.||
1590|085|I|Keep a list of all the products you use (including||
1590|086|I|prescription/nonprescription drugs and herbal products) and share||
1590|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
1590|088|I|the dosage of any medicines without your doctor's approval.||
1590|089|B|||
1590|090|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1590|091|O|has overdosed and has serious symptoms such as passing out or||
1590|092|O|trouble breathing, call 911. Otherwise, call a poison control||
1590|093|O|center right away. US residents can call 1-800-222-1222. Canada||
1590|094|O|residents can call 1-844-764-7669.||
1590|095|B|||
1590|096|N|NOTES:  Do not share this medication with others.||
1590|097|N|   This medication has been prescribed for your current condition||
1590|098|N|only. Do not use it later for another infection unless your||
1590|099|N|doctor tells you to.||
1590|100|B|||
1590|101|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1590|102|D|If it is near the time of the next dose, skip the missed dose.||
1590|103|D|Use your next dose at the regular time. Do not double the dose to||
1590|104|D|catch up.||
1590|105|B|||
1590|106|R|STORAGE:  Store at room temperature. Keep all medications away||
1590|107|R|from children and pets.||
1590|108|R|   Do not flush medications down the toilet or pour them into a||
1590|109|R|drain unless instructed to do so. Properly discard this product||
1590|110|R|when it is expired or no longer needed. Consult your pharmacist||
1590|111|R|or local waste disposal company.||
1590|112|B|||
1590|113|A|Information last revised May 2024.||
1590|114|A|Copyright(c) 2025 First Databank, Inc.||
1590|115|B|||
1591|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1591|002|Z|does NOT have all possible information about this product. This||
1591|003|Z|information does not assure that this product is safe, effective,||
1591|004|Z|or appropriate for you. This information is not individual||
1591|005|Z|medical advice and does not substitute for the advice of your||
1591|006|Z|health care professional. Always ask your health care||
1591|007|Z|professional for complete information about this product and your||
1591|008|Z|specific health needs.||
1591|009|B|||
1591|010|T|SUCROFERRIC OXYHYDROXIDE CHEWABLE TABLET - ORAL||
1591|011|F|(SOO-kroe-FER-ik OX-ee-hye-DROX-ide)||
1591|012|B|||
1591|013|C|COMMON BRAND NAME(S): Velphoro||
1591|014|B|||
1591|015|U|USES:  Sucroferric oxyhydroxide is used to lower high blood||
1591|016|U|phosphate levels in people who are on dialysis due to severe||
1591|017|U|kidney disease. Dialysis removes some phosphate from your blood,||
1591|018|U|but it is difficult to remove enough to keep your phosphate||
1591|019|U|levels balanced. Decreasing blood phosphate levels can help keep||
1591|020|U|your bones strong, prevent unsafe buildup of minerals in your||
1591|021|U|body, and may decrease the risk of heart disease and strokes that||
1591|022|U|can result from high phosphate levels.||
1591|023|U|   Sucroferric oxyhydroxide contains a form of iron which is not||
1591|024|U|absorbed by your body. It works by binding to phosphate in your||
1591|025|U|diet. The phosphate then passes out of your body in your stool.||
1591|026|B|||
1591|027|H|HOW TO USE:  See also Drug Interactions section.||
1591|028|H|   Take this medication by mouth with or right after a meal as||
1591|029|H|directed by your doctor, usually 3 times daily. The dosage is||
1591|030|H|based on your medical condition, labs, and response to treatment.||
1591|031|H|   Chew thoroughly before swallowing each dose. You may crush the||
1591|032|H|tablets to make it easier to chew them. Do not swallow the||
1591|033|H|tablets whole. This medication does not need to be swallowed with||
1591|034|H|water.||
1591|035|H|   Use this medication regularly to get the most benefit from it.||
1591|036|B|||
1591|037|S|SIDE EFFECTS:  Nausea or diarrhea may occur. If either of these||
1591|038|S|effects lasts or gets worse, tell your doctor or pharmacist||
1591|039|S|promptly.||
1591|040|S|   The iron in this medication may cause your stools to turn||
1591|041|S|black. This effect is harmless.||
1591|042|S|   This medication may stain your teeth. You may also notice an||
1591|043|S|unusual taste from the medication.||
1591|044|S|   Remember that this medication has been prescribed because your||
1591|045|S|doctor has judged that the benefit to you is greater than the||
1591|046|S|risk of side effects. Many people using this medication do not||
1591|047|S|have serious side effects.||
1591|048|S|   A very serious allergic reaction to this drug is rare.||
1591|049|S|However, get medical help right away if you notice any symptoms||
1591|050|S|of a serious allergic reaction, including: rash, itching/swelling||
1591|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1591|052|S|breathing.||
1591|053|S|   This is not a complete list of possible side effects. If you||
1591|054|S|notice other effects not listed above, contact your doctor or||
1591|055|S|pharmacist.||
1591|056|S|   In the US -||
1591|057|S|   Call your doctor for medical advice about side effects. You||
1591|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1591|059|S|www.fda.gov/medwatch.||
1591|060|S|   In Canada - Call your doctor for medical advice about side||
1591|061|S|effects. You may report side effects to Health Canada at||
1591|062|S|1-866-234-2345.||
1591|063|B|||
1591|064|P|PRECAUTIONS:  Before taking sucroferric oxyhydroxide, tell your||
1591|065|P|doctor or pharmacist if you are allergic to it; or if you have||
1591|066|P|any other allergies. This product may contain inactive||
1591|067|P|ingredients, which can cause allergic reactions or other||
1591|068|P|problems. Talk to your pharmacist for more details.||
1591|069|P|   Before using this medication, tell your doctor or pharmacist||
1591|070|P|your medical history, especially of: stomach/intestinal problems,||
1591|071|P|liver problems, high level of iron in the blood, problems chewing||
1591|072|P|tablets.||
1591|073|P|   Before having surgery, tell your doctor or dentist about all||
1591|074|P|the products you use (including prescription drugs,||
1591|075|P|nonprescription drugs, and herbal products).||
1591|076|P|   Tell your doctor if you are pregnant before using this||
1591|077|P|medication.||
1591|078|P|   It is unknown if this medication passes into breast milk.||
1591|079|P|However, it is unlikely to pass into breast milk. Consult your||
1591|080|P|doctor before breastfeeding.||
1591|081|B|||
1591|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1591|083|I|medications work or increase your risk for serious side effects.||
1591|084|I|This document does not contain all possible drug interactions.||
1591|085|I|Keep a list of all the products you use (including||
1591|086|I|prescription/nonprescription drugs and herbal products) and share||
1591|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
1591|088|I|the dosage of any medicines without your doctor's approval.||
1591|089|I|   Some products that may interact with this drug include:||
1591|090|I|levothyroxine.||
1591|091|I|   Sucroferric oxyhydroxide may interfere with the absorption of||
1591|092|I|certain other medications taken by mouth (including doxycycline).||
1591|093|I|Take these other medications at least 1 hour before taking||
1591|094|I|sucroferric oxyhydroxide. Talk to your pharmacist for more||
1591|095|I|details.||
1591|096|B|||
1591|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1591|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1591|099|O|poison control center right away. US residents can call||
1591|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1591|101|B|||
1591|102|N|NOTES:  Your doctor may tell you to follow a special diet to help||
1591|103|N|lower your blood phosphate levels. Follow the diet closely.||
1591|104|N|   Do not share this medication with others.||
1591|105|N|   Lab and/or medical tests (such as phosphate/calcium blood||
1591|106|N|levels) should be done while you are taking this medication. Keep||
1591|107|N|all medical and lab appointments. Consult your doctor for more||
1591|108|N|details.||
1591|109|B|||
1591|110|D|MISSED DOSE:  If you miss a dose, skip the missed dose unless you||
1591|111|D|have just eaten. If it is near the time of the next dose, skip||
1591|112|D|the missed dose. Take your next dose at the regular time. Do not||
1591|113|D|double the dose to catch up.||
1591|114|B|||
1591|115|R|STORAGE:  Store in the original package at room temperature away||
1591|116|R|from light and moisture. Do not store in the bathroom. Keep all||
1591|117|R|medications away from children and pets.||
1591|118|R|   Do not flush medications down the toilet or pour them into a||
1591|119|R|drain unless instructed to do so. Properly discard this product||
1591|120|R|when it is expired or no longer needed. Consult your pharmacist||
1591|121|R|or local waste disposal company.||
1591|122|B|||
1591|123|A|Information last revised July 2024.||
1591|124|A|Copyright(c) 2025 First Databank, Inc.||
1591|125|B|||
1592|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1592|002|Z|does NOT have all possible information about this product. This||
1592|003|Z|information does not assure that this product is safe, effective,||
1592|004|Z|or appropriate for you. This information is not individual||
1592|005|Z|medical advice and does not substitute for the advice of your||
1592|006|Z|health care professional. Always ask your health care||
1592|007|Z|professional for complete information about this product and your||
1592|008|Z|specific health needs.||
1592|009|B|||
1592|010|T|ESLICARBAZEPINE - ORAL||
1592|011|F|(ES-li-kar-BAZ-e-peen)||
1592|012|B|||
1592|013|C|COMMON BRAND NAME(S): Aptiom||
1592|014|B|||
1592|015|U|USES:  Eslicarbazepine is used alone or with other medications to||
1592|016|U|treat a certain type of seizure disorder (focal seizures). It||
1592|017|U|belongs to a class of drugs known as anticonvulsants.||
1592|018|U|Eslicarbazepine may reduce the number of seizures you have.||
1592|019|B|||
1592|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1592|021|H|pharmacist before you start taking eslicarbazepine and each time||
1592|022|H|you get a refill. If you have any questions, ask your doctor or||
1592|023|H|pharmacist.||
1592|024|H|   Take this medication by mouth with or without food as directed||
1592|025|H|by your doctor, usually once daily. The dosage is based on your||
1592|026|H|medical condition and response to treatment. Children's dosage is||
1592|027|H|also based on weight.||
1592|028|H|   To reduce your risk of side effects, your doctor may direct||
1592|029|H|you to start this medication at a low dose and gradually increase||
1592|030|H|your dose. Follow your doctor's instructions carefully.||
1592|031|H|   Use this medication regularly to get the most benefit from it.||
1592|032|H|To help you remember, take it at the same time each day.||
1592|033|H|   Do not increase your dose or use this drug more often or for||
1592|034|H|longer than prescribed. Your condition will not improve any||
1592|035|H|faster, and your risk of side effects will increase.||
1592|036|H|   Do not stop taking this medication without consulting your||
1592|037|H|doctor. Some conditions (such as seizures) may become worse when||
1592|038|H|this drug is suddenly stopped. Your dose may need to be gradually||
1592|039|H|decreased.||
1592|040|H|   Tell your doctor if your seizures get worse.||
1592|041|B|||
1592|042|S|SIDE EFFECTS:  Headache, shaking, drowsiness, tiredness,||
1592|043|S|dizziness, unsteadiness, feeling of spinning, nausea, or vomiting||
1592|044|S|may occur. If any of these effects last or get worse, tell your||
1592|045|S|doctor or pharmacist promptly.||
1592|046|S|   Remember that this medication has been prescribed because your||
1592|047|S|doctor has judged that the benefit to you is greater than the||
1592|048|S|risk of side effects. Many people using this medication do not||
1592|049|S|have serious side effects.||
1592|050|S|   Tell your doctor right away if you have any serious side||
1592|051|S|effects, including: rapid/uncontrollable eye movements,||
1592|052|S|blurred/double vision, loss of balance/coordination, signs of||
1592|053|S|infection (such as sore throat that doesn't go away, fever,||
1592|054|S|chills), easy bruising/bleeding, pale skin.||
1592|055|S|   A small number of people who take anticonvulsants for any||
1592|056|S|condition (such as seizure, bipolar disorder, pain) may||
1592|057|S|experience depression, suicidal thoughts/attempts, or other||
1592|058|S|mental/mood problems. Tell your doctor right away if you or your||
1592|059|S|family/caregiver notice any unusual/sudden changes in your mood,||
1592|060|S|thoughts, or behavior including signs of depression, suicidal||
1592|061|S|thoughts/attempts, thoughts about harming yourself.||
1592|062|S|   Get medical help right away if you have any very serious side||
1592|063|S|effects, including: signs of liver disease (such as nausea that||
1592|064|S|doesn't stop, dark urine, vomiting, stomach/abdominal pain,||
1592|065|S|yellowing eyes/skin), signs of low level of sodium in the blood||
1592|066|S|(such as severe nausea, extreme drowsiness, confusion,||
1592|067|S|irritability, new or worsening seizures), muscle||
1592|068|S|weakness/tenderness/pain.||
1592|069|S|   A very serious allergic reaction to this drug is rare.||
1592|070|S|However, get medical help right away if you notice any symptoms||
1592|071|S|of a serious allergic reaction, including: fever, swollen lymph||
1592|072|S|nodes, rash, itching/swelling (especially of the||
1592|073|S|face/tongue/throat), severe dizziness, trouble breathing.||
1592|074|S|   This is not a complete list of possible side effects. If you||
1592|075|S|notice other effects not listed above, contact your doctor or||
1592|076|S|pharmacist.||
1592|077|S|   In the US -||
1592|078|S|   Call your doctor for medical advice about side effects. You||
1592|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1592|080|S|www.fda.gov/medwatch.||
1592|081|S|   In Canada - Call your doctor for medical advice about side||
1592|082|S|effects. You may report side effects to Health Canada at||
1592|083|S|1-866-234-2345.||
1592|084|B|||
1592|085|P|PRECAUTIONS:  Before taking eslicarbazepine, tell your doctor or||
1592|086|P|pharmacist if you are allergic to it; or to oxcarbazepine; or to||
1592|087|P|carbamazepine; or if you have any other allergies. This product||
1592|088|P|may contain inactive ingredients, which can cause allergic||
1592|089|P|reactions or other problems. Talk to your pharmacist for more||
1592|090|P|details.||
1592|091|P|   Before using this medication, tell your doctor or pharmacist||
1592|092|P|your medical history, especially of: kidney disease, liver||
1592|093|P|disease, mineral imbalance (such as low levels of sodium in the||
1592|094|P|blood).||
1592|095|P|   This drug may make you dizzy or drowsy or blur your vision.||
1592|096|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1592|097|P|drowsy. Do not drive, use machinery, or do anything that needs||
1592|098|P|alertness or clear vision until you can do it safely. Limit||
1592|099|P|alcoholic beverages. Talk to your doctor if you are using||
1592|100|P|marijuana (cannabis).||
1592|101|P|   Before having surgery, tell your doctor or dentist about all||
1592|102|P|the products you use (including prescription drugs,||
1592|103|P|nonprescription drugs, and herbal products).||
1592|104|P|   Older adults may be more sensitive to the side effects of this||
1592|105|P|drug, especially dizziness or loss of coordination.||
1592|106|P|   During pregnancy, this medication should be used only when||
1592|107|P|clearly needed. It may harm an unborn baby. However, since||
1592|108|P|untreated seizures are a serious condition that can harm both a||
1592|109|P|pregnant woman and her unborn baby, do not stop taking this||
1592|110|P|medication unless directed by your doctor. If you are planning||
1592|111|P|pregnancy, become pregnant, or think you may be pregnant,||
1592|112|P|immediately discuss with your doctor the benefits and risks of||
1592|113|P|using this medication during pregnancy. Since hormonal birth||
1592|114|P|control may not work if taken with this medication (see also Drug||
1592|115|P|Interactions section), discuss reliable forms of birth control||
1592|116|P|with your doctor.||
1592|117|P|   This medication passes into breast milk. Consult your doctor||
1592|118|P|before breastfeeding.||
1592|119|B|||
1592|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1592|121|I|medications work or increase your risk for serious side effects.||
1592|122|I|This document does not contain all possible drug interactions.||
1592|123|I|Keep a list of all the products you use (including||
1592|124|I|prescription/nonprescription drugs and herbal products) and share||
1592|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1592|126|I|the dosage of any medicines without your doctor's approval.||
1592|127|I|   A product that may interact with this drug is: orlistat.||
1592|128|I|   This medication may decrease the effectiveness of hormonal||
1592|129|I|birth control such as pills, patch, or ring. This could cause||
1592|130|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1592|131|I|use reliable backup birth control methods while using this||
1592|132|I|medication and for at least 1 menstrual cycle after the end of||
1592|133|I|treatment. Also tell your doctor if you have any new spotting or||
1592|134|I|breakthrough bleeding, because these may be signs that your birth||
1592|135|I|control is not working well.||
1592|136|I|   Tell your doctor or pharmacist if you are taking other||
1592|137|I|products that cause drowsiness including alcohol, marijuana||
1592|138|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1592|139|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1592|140|I|zolpidem), muscle relaxants (such as carisoprodol,||
1592|141|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
1592|142|I|hydrocodone).||
1592|143|I|   Check the labels on all your medicines (such as allergy or||
1592|144|I|cough-and-cold products) because they may contain ingredients||
1592|145|I|that cause drowsiness. Ask your pharmacist about using those||
1592|146|I|products safely.||
1592|147|I|   Eslicarbazepine is very similar to oxcarbazepine. Do not use||
1592|148|I|medications containing oxcarbazepine while using eslicarbazepine.||
1592|149|I|   This medication may interfere with certain lab tests (such as||
1592|150|I|thyroid tests), possibly causing false test results. Make sure||
1592|151|I|lab personnel and all your doctors know you use this drug.||
1592|152|B|||
1592|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1592|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1592|155|O|poison control center right away. US residents can call||
1592|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1592|157|B|||
1592|158|N|NOTES:  Do not share this medication with others.||
1592|159|N|   Lab tests (such as sodium/chloride levels, liver function) may||
1592|160|N|be done before you start taking this medication and while you are||
1592|161|N|taking it. Keep all medical and lab appointments. Consult your||
1592|162|N|doctor for more details.||
1592|163|B|||
1592|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1592|165|D|remember. If it is near the time of the next dose, skip the||
1592|166|D|missed dose. Take your next dose at the regular time. Do not||
1592|167|D|double the dose to catch up.||
1592|168|B|||
1592|169|R|STORAGE:  Store at room temperature away from light and moisture.||
1592|170|R|Do not store in the bathroom. Keep all medications away from||
1592|171|R|children and pets.||
1592|172|R|   Do not flush medications down the toilet or pour them into a||
1592|173|R|drain unless instructed to do so. Properly discard this product||
1592|174|R|when it is expired or no longer needed. Consult your pharmacist||
1592|175|R|or local waste disposal company.||
1592|176|B|||
1592|177|M|MEDICAL ALERT:  Your condition can cause complications in a||
1592|178|M|medical emergency. For information about enrolling in MedicAlert,||
1592|179|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1592|180|B|||
1592|181|A|Information last revised June 2025.||
1592|182|A|Copyright(c) 2025 First Databank, Inc.||
1592|183|B|||
1593|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1593|002|Z|does NOT have all possible information about this product. This||
1593|003|Z|information does not assure that this product is safe, effective,||
1593|004|Z|or appropriate for you. This information is not individual||
1593|005|Z|medical advice and does not substitute for the advice of your||
1593|006|Z|health care professional. Always ask your health care||
1593|007|Z|professional for complete information about this product and your||
1593|008|Z|specific health needs.||
1593|009|B|||
1593|010|T|UMECLIDINIUM/VILANTEROL DISK INHALER - ORAL INHALATION||
1593|011|F|(ue-ME-kli-DIN-ee-um/vye-LAN-ter-ol)||
1593|012|B|||
1593|013|C|COMMON BRAND NAME(S): Anoro Ellipta||
1593|014|B|||
1593|015|U|USES:  This product is used to control and prevent symptoms (such||
1593|016|U|as wheezing and shortness of breath) caused by ongoing lung||
1593|017|U|disease (chronic obstructive pulmonary disease-COPD, which||
1593|018|U|includes chronic bronchitis and emphysema). Controlling symptoms||
1593|019|U|of breathing problems helps you stay active. This inhaler||
1593|020|U|contains 2 medications: umeclidinium and vilanterol. Both drugs||
1593|021|U|work by relaxing the muscles around the airways so that they open||
1593|022|U|up and you can breathe more easily. Umeclidinium belongs to a||
1593|023|U|class of drugs known as anticholinergics. Vilanterol belongs to||
1593|024|U|the class of drugs known as long-acting beta agonists (LABAs).||
1593|025|U|Both drugs are also known as bronchodilators.||
1593|026|U|   This medication must be used regularly to be effective. It||
1593|027|U|does not work right away and should not be used to relieve sudden||
1593|028|U|shortness of breath. If sudden breathing problems occur, use your||
1593|029|U|quick-relief inhaler as prescribed.||
1593|030|U|   Umeclidinium/vilanterol is not approved to treat asthma.||
1593|031|U|People with asthma using long-acting inhaled beta agonists (such||
1593|032|U|as vilanterol) without also using an inhaled corticosteroid may||
1593|033|U|have an increased risk of serious (sometimes fatal) breathing||
1593|034|U|problems.||
1593|035|B|||
1593|036|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1593|037|H|your pharmacist before you start using this medication and each||
1593|038|H|time you get a refill. Follow the illustrated directions for the||
1593|039|H|proper use of this medication. If you have any questions, ask||
1593|040|H|your doctor or pharmacist.||
1593|041|H|   Inhale this medication by mouth as directed by your doctor,||
1593|042|H|usually once daily. Do not open the cover of the inhaler until||
1593|043|H|you are ready to use it. Each time you open the cover, you||
1593|044|H|prepare a dose of the medication. If you open and close the cover||
1593|045|H|without inhaling the medication, you will lose the dose. To avoid||
1593|046|H|wasting a dose, do not close the cover until after you have||
1593|047|H|inhaled the medication. You may or may not taste/feel the drug||
1593|048|H|when you inhale. Do not exhale into the device.||
1593|049|H|   Use this medication regularly to get the most benefit from it.||
1593|050|H|Use it at the same time every day. Do not use it more than one||
1593|051|H|time each day.||
1593|052|H|   Do not increase your dose, use this medication more often, or||
1593|053|H|stop using it without first consulting your doctor. Your||
1593|054|H|condition will not improve any faster, and your risk of side||
1593|055|H|effects will increase.||
1593|056|H|   If you are using other inhalers at the same time, wait at||
1593|057|H|least 1 minute between the use of each medication.||
1593|058|H|   If you have been using a quick-relief inhaler (such as||
1593|059|H|albuterol, also called salbutamol in some countries) on a regular||
1593|060|H|daily schedule (such as 4 times daily), you must stop this||
1593|061|H|schedule and only use the quick-relief inhaler as needed for||
1593|062|H|sudden shortness of breath. Consult your doctor for details.||
1593|063|H|   Learn which of your inhalers you should use every day and||
1593|064|H|which you should use if your breathing suddenly worsens||
1593|065|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1593|066|H|should do if you have new or worsening cough or shortness of||
1593|067|H|breath, wheezing, increased sputum, waking up at night with||
1593|068|H|trouble breathing, if you use your quick-relief inhaler more||
1593|069|H|often, or if your quick-relief inhaler does not seem to be||
1593|070|H|working well. Learn when you can treat sudden breathing problems||
1593|071|H|by yourself and when you must get medical help right away.||
1593|072|H|   Tell your doctor if your condition does not get better or if||
1593|073|H|it gets worse.||
1593|074|B|||
1593|075|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1593|076|S|because your doctor has judged that the benefit to you is greater||
1593|077|S|than the risk of side effects. Many people using this medication||
1593|078|S|do not have serious side effects.||
1593|079|S|   Tell your doctor right away if you have any serious side||
1593|080|S|effects, including: shaking (tremor), nervousness,||
1593|081|S|difficult/painful urination, muscle cramps/weakness, increased||
1593|082|S|thirst/urination.||
1593|083|S|   This medication may raise your blood pressure. Check your||
1593|084|S|blood pressure regularly and tell your doctor if the results are||
1593|085|S|high.||
1593|086|S|   Rarely, this medication may cause sudden, severe||
1593|087|S|wheezing/trouble breathing immediately after you use it. If this||
1593|088|S|happens, use your quick-relief inhaler and get medical help right||
1593|089|S|away.||
1593|090|S|   Get medical help right away if you have any very serious side||
1593|091|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1593|092|S|dizziness, fainting, eye pain/swelling/redness, vision changes||
1593|093|S|(such as seeing rainbows around lights at night, blurred vision).||
1593|094|S|   A very serious allergic reaction to this drug is rare.||
1593|095|S|However, get medical help right away if you notice any symptoms||
1593|096|S|of a serious allergic reaction, including: rash, itching/swelling||
1593|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1593|098|S|breathing.||
1593|099|S|   This is not a complete list of possible side effects. If you||
1593|100|S|notice other effects not listed above, contact your doctor or||
1593|101|S|pharmacist.||
1593|102|S|   In the US -||
1593|103|S|   Call your doctor for medical advice about side effects. You||
1593|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1593|105|S|www.fda.gov/medwatch.||
1593|106|S|   In Canada - Call your doctor for medical advice about side||
1593|107|S|effects. You may report side effects to Health Canada at||
1593|108|S|1-866-234-2345.||
1593|109|B|||
1593|110|P|PRECAUTIONS:  Before using umeclidinium/vilanterol, tell your||
1593|111|P|doctor or pharmacist if you are allergic to either drug, or if||
1593|112|P|you have any other allergies. This product may contain inactive||
1593|113|P|ingredients (such as milk proteins), which can cause allergic||
1593|114|P|reactions or other problems. Talk to your pharmacist for more||
1593|115|P|details.||
1593|116|P|   Before using this medication, tell your doctor or pharmacist||
1593|117|P|your medical history, especially of: heart problems (such as||
1593|118|P|chest pain, irregular heartbeat), high blood pressure, seizures,||
1593|119|P|overactive thyroid, diabetes, personal or family history of||
1593|120|P|glaucoma (angle-closure type), difficulty urinating (such as due||
1593|121|P|to an enlarged prostate).||
1593|122|P|   Umeclidinium/vilanterol may cause a condition that affects the||
1593|123|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
1593|124|P|serious (rarely fatal) fast/irregular heartbeat and other||
1593|125|P|symptoms (such as severe dizziness, fainting) that need medical||
1593|126|P|attention right away.||
1593|127|P|   The risk of QT prolongation may be increased if you have||
1593|128|P|certain medical conditions or are taking other drugs that may||
1593|129|P|cause QT prolongation. Before using umeclidinium/vilanterol, tell||
1593|130|P|your doctor or pharmacist of all the drugs you take and if you||
1593|131|P|have any of the following conditions: certain heart problems||
1593|132|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
1593|133|P|family history of certain heart problems (QT prolongation in the||
1593|134|P|EKG, sudden cardiac death).||
1593|135|P|   Low levels of potassium or magnesium in the blood may also||
1593|136|P|increase your risk of QT prolongation. This risk may increase if||
1593|137|P|you use certain drugs (such as diuretics/"water pills") or if you||
1593|138|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1593|139|P|Talk to your doctor about using umeclidinium/vilanterol safely.||
1593|140|P|   Before having surgery, tell your doctor or dentist about all||
1593|141|P|the products you use (including prescription drugs,||
1593|142|P|nonprescription drugs, and herbal products).||
1593|143|P|   Older adults may be more sensitive to the side effects of this||
1593|144|P|drug, especially QT prolongation (see above).||
1593|145|P|   During pregnancy, this medication should be used only when||
1593|146|P|clearly needed. Discuss the risks and benefits with your doctor.||
1593|147|P|   It is unknown if this medication passes into breast milk.||
1593|148|P|Consult your doctor before breastfeeding.||
1593|149|B|||
1593|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1593|151|I|medications work or increase your risk for serious side effects.||
1593|152|I|This document does not contain all possible drug interactions.||
1593|153|I|Keep a list of all the products you use (including||
1593|154|I|prescription/nonprescription drugs and herbal products) and share||
1593|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
1593|156|I|the dosage of any medicines without your doctor's approval.||
1593|157|I|   Do not use other LABA drugs (such as formoterol, salmeterol)||
1593|158|I|while using this medication.||
1593|159|B|||
1593|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1593|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1593|162|O|poison control center right away. US residents can call||
1593|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1593|164|O|Symptoms of overdose may include: shaking (tremor), chest pain,||
1593|165|O|fast/irregular heartbeat, seizures.||
1593|166|B|||
1593|167|N|NOTES:  Do not share this medication with others.||
1593|168|N|   Lab and/or medical tests (such as lung function, blood||
1593|169|N|pressure, pulse/heart rate) should be done while you are using||
1593|170|N|this medication. Keep all medical and lab appointments. Consult||
1593|171|N|your doctor for more details.||
1593|172|N|   Avoid smoking and other things that can worsen breathing||
1593|173|N|problems. Because the flu virus can also worsen breathing||
1593|174|N|problems, ask your doctor or pharmacist if you should have a flu||
1593|175|N|shot every year.||
1593|176|B|||
1593|177|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1593|178|D|If it is near the time of the next dose, skip the missed dose.||
1593|179|D|Use your next dose at the regular time. Do not double the dose to||
1593|180|D|catch up. Do not use more than one dose each day.||
1593|181|B|||
1593|182|R|STORAGE:  Store at room temperature away from light, heat, and||
1593|183|R|moisture. Do not store in the bathroom. Do not open the sealed||
1593|184|R|tray until you are ready to use the new inhaler. Once the inhaler||
1593|185|R|is removed from the tray, this medication expires after 6 weeks.||
1593|186|R|Keep all medications away from children and pets.||
1593|187|R|   Do not flush medications down the toilet or pour them into a||
1593|188|R|drain unless instructed to do so. Properly discard this product||
1593|189|R|when it is expired or no longer needed. Consult your pharmacist||
1593|190|R|or local waste disposal company.||
1593|191|B|||
1593|192|M|MEDICAL ALERT:  Your condition can cause complications in a||
1593|193|M|medical emergency. For information about enrolling in MedicAlert,||
1593|194|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1593|195|B|||
1593|196|A|Information last revised July 2025.||
1593|197|A|Copyright(c) 2025 First Databank, Inc.||
1593|198|B|||
1595|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1595|002|Z|does NOT have all possible information about this product. This||
1595|003|Z|information does not assure that this product is safe, effective,||
1595|004|Z|or appropriate for you. This information is not individual||
1595|005|Z|medical advice and does not substitute for the advice of your||
1595|006|Z|health care professional. Always ask your health care||
1595|007|Z|professional for complete information about this product and your||
1595|008|Z|specific health needs.||
1595|009|B|||
1595|010|T|TASIMELTEON - ORAL||
1595|011|F|(TAS-i-MEL-tee-on)||
1595|012|B|||
1595|013|C|COMMON BRAND NAME(S): Hetlioz||
1595|014|B|||
1595|015|U|USES:  Tasimelteon is used to treat certain sleep disorders||
1595|016|U|(non-24-hour sleep-wake disorder, sleep disturbances in||
1595|017|U|Smith-Magenis Syndrome). It works like a natural substance called||
1595|018|U|melatonin that your body produces. It helps to control your||
1595|019|U|sleep-wake cycle (circadian rhythm). Tasimelteon may improve your||
1595|020|U|ability to sleep at night and to be more active during the day.||
1595|021|B|||
1595|022|H|HOW TO USE:  Take this medication by mouth on an empty stomach as||
1595|023|H|directed by your doctor, usually one hour before bedtime, at the||
1595|024|H|same time every night. The dosage is based on your medical||
1595|025|H|condition and response to treatment. Children's dosage is also||
1595|026|H|based on weight. If you are using the capsule form, swallow the||
1595|027|H|capsules whole.||
1595|028|H|   If you are using the liquid form of this medication, read the||
1595|029|H|Instructions for Use Leaflet if available from your pharmacist||
1595|030|H|before you start using tasimelteon suspension and each time you||
1595|031|H|get a refill. Shake the bottle well for at least 30 seconds||
1595|032|H|before each dose. Carefully measure the dose using a special||
1595|033|H|measuring device/spoon. Do not use a household spoon because you||
1595|034|H|may not get the correct dose. If you have any questions, ask your||
1595|035|H|doctor or pharmacist.||
1595|036|H|   It is very important to take this medication at the same time||
1595|037|H|each night so that you can form a normal sleep-wake cycle. See||
1595|038|H|also Missed Dose section.||
1595|039|H|   It may take up to several months before you get the full||
1595|040|H|benefit of this drug.||
1595|041|H|   Tell your doctor if your condition does not get better or if||
1595|042|H|it gets worse.||
1595|043|B|||
1595|044|S|SIDE EFFECTS:  Headache, nightmares, or strange dreams may occur.||
1595|045|S|If any of these effects last or get worse, tell your doctor or||
1595|046|S|pharmacist promptly. Tasimelteon may also make you drowsy during||
1595|047|S|the day. Talk to your doctor or pharmacist if you have daytime||
1595|048|S|drowsiness.||
1595|049|S|   Remember that this medication has been prescribed because your||
1595|050|S|doctor has judged that the benefit to you is greater than the||
1595|051|S|risk of side effects. Many people using this medication do not||
1595|052|S|have serious side effects.||
1595|053|S|   A very serious allergic reaction to this drug is rare.||
1595|054|S|However, get medical help right away if you notice any symptoms||
1595|055|S|of a serious allergic reaction, including: rash, itching/swelling||
1595|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1595|057|S|breathing.||
1595|058|S|   This is not a complete list of possible side effects. If you||
1595|059|S|notice other effects not listed above, contact your doctor or||
1595|060|S|pharmacist.||
1595|061|S|   In the US -||
1595|062|S|   Call your doctor for medical advice about side effects. You||
1595|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1595|064|S|www.fda.gov/medwatch.||
1595|065|S|   In Canada - Call your doctor for medical advice about side||
1595|066|S|effects. You may report side effects to Health Canada at||
1595|067|S|1-866-234-2345.||
1595|068|B|||
1595|069|P|PRECAUTIONS:  Before taking tasimelteon, tell your doctor or||
1595|070|P|pharmacist if you are allergic to it; or if you have any other||
1595|071|P|allergies. This product may contain inactive ingredients, which||
1595|072|P|can cause allergic reactions or other problems. Talk to your||
1595|073|P|pharmacist for more details.||
1595|074|P|   Before using this medication, tell your doctor or pharmacist||
1595|075|P|your medical history, especially of: liver disease.||
1595|076|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
1595|077|P|can make you more drowsy. Do not drive, use machinery, or do||
1595|078|P|anything that needs alertness until you can do it safely. Limit||
1595|079|P|alcoholic beverages. Talk to your doctor if you are using||
1595|080|P|marijuana (cannabis).||
1595|081|P|   Liquid products may contain sugar and/or aspartame. Caution is||
1595|082|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
1595|083|P|condition that requires you to limit/avoid these substances in||
1595|084|P|your diet. Ask your doctor or pharmacist about using this product||
1595|085|P|safely.||
1595|086|P|   Before having surgery, tell your doctor or dentist about all||
1595|087|P|the products you use (including prescription drugs,||
1595|088|P|nonprescription drugs, and herbal products).||
1595|089|P|   During pregnancy, this medication should be used only when||
1595|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
1595|091|P|   It is unknown if this medication passes into breast milk.||
1595|092|P|Consult your doctor before breastfeeding.||
1595|093|B|||
1595|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1595|095|I|medications work or increase your risk for serious side effects.||
1595|096|I|This document does not contain all possible drug interactions.||
1595|097|I|Keep a list of all the products you use (including||
1595|098|I|prescription/nonprescription drugs and herbal products) and share||
1595|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
1595|100|I|the dosage of any medicines without your doctor's approval.||
1595|101|I|   Other medications can affect the removal of tasimelteon from||
1595|102|I|your body, which may affect how tasimelteon works. Examples||
1595|103|I|include ciprofloxacin, fluvoxamine, rifamycins (such as||
1595|104|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
1595|105|I|as carbamazepine, phenytoin), viloxazine, among others.||
1595|106|I|   Tell your doctor or pharmacist if you are taking other||
1595|107|I|products that cause drowsiness such as opioid pain or cough||
1595|108|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1595|109|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
1595|110|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1595|111|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1595|112|I|diphenhydramine).||
1595|113|I|   Check the labels on all your medicines (such as allergy or||
1595|114|I|cough-and-cold products) because they may contain ingredients||
1595|115|I|that cause drowsiness. Ask your pharmacist about using those||
1595|116|I|products safely.||
1595|117|I|   Cigarette smoking decreases blood levels of this medication.||
1595|118|I|Tell your doctor if you smoke or if you have recently stopped||
1595|119|I|smoking.||
1595|120|B|||
1595|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1595|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1595|123|O|poison control center right away. US residents can call||
1595|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1595|125|B|||
1595|126|N|NOTES:  Do not share this medication with others.||
1595|127|B|||
1595|128|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1595|129|D|next dose at the regular time. Do not double the dose to catch||
1595|130|D|up.||
1595|131|B|||
1595|132|R|STORAGE:  Store the capsules at room temperature away from light||
1595|133|R|and moisture. Do not store in the bathroom. Store the liquid form||
1595|134|R|in the refrigerator. Once the bottle for the liquid form is||
1595|135|R|opened, the medication expires after 5 weeks (for the 48||
1595|136|R|milliliter bottle) or after 8 weeks (for the 158 milliliter||
1595|137|R|bottle). Keep all medications away from children and pets.||
1595|138|R|   Do not flush medications down the toilet or pour them into a||
1595|139|R|drain unless instructed to do so. Properly discard this product||
1595|140|R|when it is expired or no longer needed. Consult your pharmacist||
1595|141|R|or local waste disposal company.||
1595|142|B|||
1595|143|A|Information last revised September 2024.||
1595|144|A|Copyright(c) 2025 First Databank, Inc.||
1595|145|B|||
1596|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1596|002|Z|does NOT have all possible information about this product. This||
1596|003|Z|information does not assure that this product is safe, effective,||
1596|004|Z|or appropriate for you. This information is not individual||
1596|005|Z|medical advice and does not substitute for the advice of your||
1596|006|Z|health care professional. Always ask your health care||
1596|007|Z|professional for complete information about this product and your||
1596|008|Z|specific health needs.||
1596|009|B|||
1596|010|T|SODIUM PHOSPHATE MONOBASIC/DIBASIC ENEMA - RECTAL||
1596|011|F|(SOE-dee-um FOS-fate MON-oh-BAY-sik/dye-BAY-sik)||
1596|012|B|||
1596|013|C|COMMON BRAND NAME(S): Fleet Enema||
1596|014|B|||
1596|015|U|USES:  This medication may be used to relieve occasional||
1596|016|U|constipation. However, when treating constipation, you should use||
1596|017|U|milder products (such as stool softeners, bulk-forming laxatives)||
1596|018|U|whenever possible. Talk to your doctor or pharmacist about other||
1596|019|U|treatment options. Your doctor may also prescribe this product||
1596|020|U|(usually along with other products) to clean stool from the||
1596|021|U|intestines before surgery or certain bowel procedures (such as||
1596|022|U|colonoscopy, radiography). Use it only as directed by your||
1596|023|U|doctor.||
1596|024|U|   Sodium phosphate is a saline laxative that is thought to work||
1596|025|U|by increasing fluid in the small intestine. It usually causes a||
1596|026|U|bowel movement after 1 to 5 minutes.||
1596|027|U|   Do not use this medication in children younger than 2 years of||
1596|028|U|age.||
1596|029|B|||
1596|030|H|HOW TO USE:  This product is for rectal use only. Follow all||
1596|031|H|directions on the product package. If you have any questions, ask||
1596|032|H|your doctor or pharmacist. Since your bowel movements can be very||
1596|033|H|large/watery, drink plenty of clear liquids so that you do not||
1596|034|H|become dehydrated.||
1596|035|H|   Wash your hands before and after using this product. Remove||
1596|036|H|the protective shield from the enema. Lie on your left side with||
1596|037|H|knee bent. Or if you find it more comfortable, you may kneel,||
1596|038|H|then lower your head and chest forward until the left side of||
1596|039|H|your face is resting on a flat surface with your left arm folded||
1596|040|H|comfortably. With steady pressure, gently insert enema tip into||
1596|041|H|the rectum with a slight side-to-side movement, pointing the tip||
1596|042|H|toward the navel. Do not force the enema tip into the rectum||
1596|043|H|because you could hurt yourself. Squeeze the bottle until the||
1596|044|H|recommended amount of the drug is inside the rectum. You do not||
1596|045|H|need to empty the bottle completely because it has more liquid||
1596|046|H|than needed. Remove the bottle tip from the rectum. Stay in||
1596|047|H|position for 1 to 5 minutes until you feel a strong urge to have||
1596|048|H|a bowel movement.||
1596|049|H|   If your doctor has directed you to use this product before||
1596|050|H|surgery or a bowel procedure, your doctor should tell you how||
1596|051|H|long before the surgery/procedure you should use this product.||
1596|052|H|Follow your doctor's directions closely. After using the||
1596|053|H|medication, drink plenty of clear liquids as directed by your||
1596|054|H|doctor. Doing so will help prevent serious side effects (such as||
1596|055|H|kidney problems, dehydration). Talk with your doctor about types||
1596|056|H|of liquids you can drink before your procedure.||
1596|057|H|   The dosage is based on your age, medical condition, and||
1596|058|H|response to treatment. Do not use more of this medication than||
1596|059|H|directed, use this medication more often than once in 24 hours,||
1596|060|H|or use this medication for more than 3 days unless directed by||
1596|061|H|your doctor. Also, do not use any other laxative products while||
1596|062|H|using this product unless directed by your doctor. Doing so may||
1596|063|H|increase your risk for serious side effects.||
1596|064|H|   This medication may cause a condition known as laxative||
1596|065|H|dependence, especially if you use it regularly for a long time.||
1596|066|H|In such cases, your bowel may stop working normally and you may||
1596|067|H|have ongoing constipation. For most people with occasional||
1596|068|H|constipation, a bulk-forming laxative (such as psyllium) or a||
1596|069|H|stool softener (such as docusate) is a better and safer product.||
1596|070|H|To prevent laxative dependence, consult your doctor if you need||
1596|071|H|to use this medication or other laxative products for more than 7||
1596|072|H|days.||
1596|073|H|   Tell your doctor right away if the enema tip causes rectal||
1596|074|H|bleeding/pain, if you do not have a bowel movement within 30||
1596|075|H|minutes of using the product, if you have symptoms of dehydration||
1596|076|H|(see Side Effects section), or if you think you may have a||
1596|077|H|serious medical problem.||
1596|078|B|||
1596|079|S|SIDE EFFECTS:  Mild abdominal discomfort/cramps or gas may occur.||
1596|080|S|If any of these effects last or get worse, tell your doctor or||
1596|081|S|pharmacist promptly.||
1596|082|S|   If your doctor has directed you to use this product, remember||
1596|083|S|that your doctor has judged that the benefit to you is greater||
1596|084|S|than the risk of side effects. Many people using this product do||
1596|085|S|not have serious side effects.||
1596|086|S|   Diarrhea that doesn't stop may result in dehydration. This may||
1596|087|S|cause serious side effects to the kidneys and heart. Contact your||
1596|088|S|doctor promptly if you notice any symptoms of dehydration, such||
1596|089|S|as unusual dry mouth/increased thirst, lack of tears,||
1596|090|S|dizziness/lightheadedness, or pale/wrinkled skin.||
1596|091|S|   Tell your doctor right away if you have any serious side||
1596|092|S|effects, including: stomach/abdominal pain that is severe or||
1596|093|S|doesn't go away, diarrhea that doesn't stop, signs of kidney||
1596|094|S|problems (such as change in the amount of urine), bloody stools,||
1596|095|S|rectal bleeding, mental/mood changes (such as confusion, unusual||
1596|096|S|drowsiness), muscle weakness/spasm, swelling of the||
1596|097|S|hands/ankles/feet.||
1596|098|S|   Get medical help right away if you have any very serious side||
1596|099|S|effects, including: slow/irregular/fast heartbeat, seizures.||
1596|100|S|   A very serious allergic reaction to this drug is rare.||
1596|101|S|However, get medical help right away if you notice any symptoms||
1596|102|S|of a serious allergic reaction, including: rash, itching/swelling||
1596|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1596|104|S|breathing.||
1596|105|S|   This is not a complete list of possible side effects. If you||
1596|106|S|notice other effects not listed above, contact your doctor or||
1596|107|S|pharmacist.||
1596|108|S|   In the US -||
1596|109|S|   Call your doctor for medical advice about side effects. You||
1596|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1596|111|S|www.fda.gov/medwatch.||
1596|112|S|   In Canada - Call your doctor for medical advice about side||
1596|113|S|effects. You may report side effects to Health Canada at||
1596|114|S|1-866-234-2345.||
1596|115|B|||
1596|116|P|PRECAUTIONS:  Before using sodium phosphate, tell your doctor or||
1596|117|P|pharmacist if you are allergic to it; or if you have any other||
1596|118|P|allergies. This product may contain inactive ingredients, which||
1596|119|P|can cause allergic reactions or other problems. Talk to your||
1596|120|P|pharmacist for more details.||
1596|121|P|   Before using this medication, tell your doctor or pharmacist||
1596|122|P|your medical history, especially of: dehydration, high/low levels||
1596|123|P|of certain minerals in the blood (such as potassium, calcium,||
1596|124|P|sodium, phosphate), kidney disease, current stomach/abdominal||
1596|125|P|symptoms (such as nausea/vomiting that doesn't stop, pain,||
1596|126|P|cramping), bowel problems (such as blockage, ulcerative colitis,||
1596|127|P|hemorrhoids), laxative use for constipation in the past week,||
1596|128|P|heart disease (such as heart failure, irregular heartbeat), liver||
1596|129|P|disease, sodium-restricted diet.||
1596|130|P|   Consult your doctor before using this product if you have had||
1596|131|P|a sudden change in bowel habits lasting more than 2 weeks or if||
1596|132|P|you need to use a laxative daily for more than 1 week. These||
1596|133|P|could be symptoms of a serious medical problem.||
1596|134|P|   Before having surgery, tell your doctor or dentist about all||
1596|135|P|the products you use (including prescription drugs,||
1596|136|P|nonprescription drugs, and herbal products).||
1596|137|P|   Young children may be more sensitive to the side effects of||
1596|138|P|this drug, especially dehydration and kidney problems.||
1596|139|P|   Older adults may be more sensitive to the side effects of this||
1596|140|P|drug, especially dehydration and kidney problems.||
1596|141|P|   During pregnancy, this medication should be used only when||
1596|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
1596|143|P|   It is unknown if this drug passes into breast milk. Consult||
1596|144|P|your doctor before breastfeeding.||
1596|145|B|||
1596|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1596|147|I|medications work or increase your risk for serious side effects.||
1596|148|I|This document does not contain all possible drug interactions.||
1596|149|I|Keep a list of all the products you use (including||
1596|150|I|prescription/nonprescription drugs and herbal products) and share||
1596|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
1596|152|I|the dosage of any medicines without your doctor's approval.||
1596|153|I|   Some products that may interact with this drug include: other||
1596|154|I|drugs that may affect the kidneys (including ACE inhibitors such||
1596|155|I|as lisinopril, ARBs such as valsartan, diuretics/"water pills"||
1596|156|I|such as furosemide/hydrochlorothiazide, NSAIDs such as||
1596|157|I|ibuprofen/naproxen).||
1596|158|I|   The watery bowel movements from sodium phosphate may cause||
1596|159|I|your body to absorb less of your regular medicines and get less||
1596|160|I|benefit from them. Consult your doctor or pharmacist about how to||
1596|161|I|reduce this effect.||
1596|162|B|||
1596|163|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1596|164|O|has overdosed and has serious symptoms such as passing out or||
1596|165|O|trouble breathing, call 911. Otherwise, call a poison control||
1596|166|O|center right away. US residents can call 1-800-222-1222. Canada||
1596|167|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1596|168|O|include: muscle weakness, fast/slow/irregular heartbeat,||
1596|169|O|mental/mood changes (such as confusion), change in the amount of||
1596|170|O|urine.||
1596|171|B|||
1596|172|N|NOTES:  Lab and/or medical tests (such as kidney function, blood||
1596|173|N|mineral levels) may be done while you are using this medication.||
1596|174|N|Keep all medical and lab appointments. Consult your doctor for||
1596|175|N|more details.||
1596|176|N|   To maintain normal bowel habits, it is important to drink||
1596|177|N|plenty of fluids (four to six 8-ounce glasses daily), eat foods||
1596|178|N|high in fiber, and exercise regularly.||
1596|179|B|||
1596|180|D|MISSED DOSE:  Not applicable.||
1596|181|B|||
1596|182|R|STORAGE:  Refer to storage information printed on the package. If||
1596|183|R|you have any questions about storage, ask your pharmacist. Keep||
1596|184|R|all medications away from children and pets.||
1596|185|R|   Do not flush medications down the toilet or pour them into a||
1596|186|R|drain unless instructed to do so. Properly discard this product||
1596|187|R|when it is expired or no longer needed. Consult your pharmacist||
1596|188|R|or local waste disposal company.||
1596|189|B|||
1596|190|A|Information last revised January 2025.||
1596|191|A|Copyright(c) 2025 First Databank, Inc.||
1596|192|B|||
1597|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1597|002|Z|does NOT have all possible information about this product. This||
1597|003|Z|information does not assure that this product is safe, effective,||
1597|004|Z|or appropriate for you. This information is not individual||
1597|005|Z|medical advice and does not substitute for the advice of your||
1597|006|Z|health care professional. Always ask your health care||
1597|007|Z|professional for complete information about this product and your||
1597|008|Z|specific health needs.||
1597|009|B|||
1597|010|T|TESTOSTERONE UNDECANOATE - INTRAMUSCULAR||
1597|011|F|(tes-TOS-ter-one un-DEK-a-NOE-ate)||
1597|012|B|||
1597|013|C|COMMON BRAND NAME(S): Aveed||
1597|014|B|||
1597|015|W|WARNING:  This medication can rarely cause a certain serious lung||
1597|016|W|problem (pulmonary oil microembolism-POME), caused by tiny||
1597|017|W|droplets of oil that have traveled to the lungs. Symptoms may||
1597|018|W|include cough/urge to cough, difficulty breathing, sweating,||
1597|019|W|tightening of the throat, chest pain, dizziness, or fainting.||
1597|020|W|Most of the time, symptoms last only a few minutes and improve||
1597|021|W|with medical help. However, symptoms have sometimes lasted up to||
1597|022|W|several hours, or worsened and required treatment in a hospital.||
1597|023|W|Serious (rarely fatal) allergic reactions may also occur. These||
1597|024|W|side effects may happen during or right after each injection. To||
1597|025|W|be sure that you do not have a serious reaction, you will need to||
1597|026|W|stay in a health care setting for 30 minutes after each injection||
1597|027|W|so your doctor can carefully monitor you and provide medical help||
1597|028|W|if needed.||
1597|029|W|   To receive testosterone undecanoate injection in the United||
1597|030|W|States, you must understand, agree to, and carefully follow the||
1597|031|W|requirements of the REMS Program for this medication. If you live||
1597|032|W|in Canada or any other country, consult your doctor and||
1597|033|W|pharmacist for your country's regulations.||
1597|034|B|||
1597|035|U|USES:  This medication is used in men who do not make enough of a||
1597|036|U|natural substance called testosterone. Testosterone belongs to a||
1597|037|U|class of drugs known as androgens. Testosterone helps the body to||
1597|038|U|develop and maintain male sexual characteristics (masculinity),||
1597|039|U|such as a deep voice and body hair. It also helps to maintain||
1597|040|U|muscle and prevent bone loss, and is necessary for natural sexual||
1597|041|U|ability/desire.||
1597|042|U|   Testosterone may also be used in certain adolescent boys to||
1597|043|U|cause puberty in those with delayed puberty.||
1597|044|U|   This product should not be used in women.||
1597|045|B|||
1597|046|H|HOW TO USE:  Read the Medication Guide provided by your||
1597|047|H|pharmacist before you start using this medication and each time||
1597|048|H|you receive an injection. If you have any questions, ask your||
1597|049|H|doctor or pharmacist.||
1597|050|H|   This medication is given by injection into the buttock muscle||
1597|051|H|as directed by your doctor. After the first dose, it is usually||
1597|052|H|given 4 weeks later, then every 10 weeks. The dosage is based on||
1597|053|H|your medical condition, testosterone blood levels, and response||
1597|054|H|to treatment.||
1597|055|H|   Use this medication regularly to get the most benefit from it.||
1597|056|H|To help you remember, mark your calendar with a reminder.||
1597|057|H|   Misuse or abuse of testosterone can cause serious side effects||
1597|058|H|such as heart disease (including heart attack), stroke, liver||
1597|059|H|disease, mental/mood problems, abnormal drug-seeking behavior, or||
1597|060|H|improper bone growth (in adolescents). Do not increase your dose||
1597|061|H|or use this drug more often or for longer than prescribed. When||
1597|062|H|testosterone is misused or abused, you may have withdrawal||
1597|063|H|symptoms (such as depression, irritability, tiredness) when you||
1597|064|H|suddenly stop using the drug. These symptoms may last from weeks||
1597|065|H|to months.||
1597|066|H|   Tell your doctor if your condition does not get better or if||
1597|067|H|it gets worse.||
1597|068|B|||
1597|069|S|SIDE EFFECTS:  See also Warning section.||
1597|070|S|   Nausea, vomiting, headache, skin color changes,||
1597|071|S|increased/decreased sexual interest, oily skin, hair loss, and||
1597|072|S|acne may occur. Pain or redness at the injection site may also||
1597|073|S|occur. If any of these effects last or get worse, tell your||
1597|074|S|doctor or pharmacist promptly.||
1597|075|S|   Remember that this medication has been prescribed because your||
1597|076|S|doctor has judged that the benefit to you is greater than the||
1597|077|S|risk of side effects. Many people using this medication do not||
1597|078|S|have serious side effects.||
1597|079|S|   This medication may raise your blood pressure. Check your||
1597|080|S|blood pressure regularly and tell your doctor if the results are||
1597|081|S|high. Your doctor may control your blood pressure with||
1597|082|S|medication.||
1597|083|S|   Tell your doctor right away if you have any serious side||
1597|084|S|effects, including: breast swelling/tenderness, mental/mood||
1597|085|S|changes (such as depression, agitation, hostility), unusual||
1597|086|S|snoring or difficulty breathing during sleep, swelling||
1597|087|S|hands/ankles/feet, symptoms of liver problems (such as||
1597|088|S|nausea/vomiting that doesn't stop, loss of appetite, severe||
1597|089|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), trouble||
1597|090|S|urinating, increased urination (especially at night), too||
1597|091|S|frequent/prolonged erections, fast/irregular heartbeat.||
1597|092|S|   Get medical help right away if you have any very serious side||
1597|093|S|effects, including: shortness of breath/rapid breathing,||
1597|094|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1597|095|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1597|096|S|sudden/severe headaches, trouble speaking, weakness on one side||
1597|097|S|of the body, sudden vision changes.||
1597|098|S|   Rarely, males may have a painful or prolonged erection lasting||
1597|099|S|4 or more hours. If this occurs, get medical help right away, or||
1597|100|S|permanent problems could occur.||
1597|101|S|   A very serious allergic reaction to this drug is rare.||
1597|102|S|However, get medical help right away if you notice any symptoms||
1597|103|S|of a serious allergic reaction, including: rash, itching/swelling||
1597|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1597|105|S|breathing.||
1597|106|S|   This is not a complete list of possible side effects. If you||
1597|107|S|notice other effects not listed above, contact your doctor or||
1597|108|S|pharmacist.||
1597|109|S|   In the US -||
1597|110|S|   Call your doctor for medical advice about side effects. You||
1597|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1597|112|S|www.fda.gov/medwatch.||
1597|113|S|   In Canada - Call your doctor for medical advice about side||
1597|114|S|effects. You may report side effects to Health Canada at||
1597|115|S|1-866-234-2345.||
1597|116|B|||
1597|117|P|PRECAUTIONS:  Before using testosterone, tell your doctor or||
1597|118|P|pharmacist if you are allergic to it; or if you have any other||
1597|119|P|allergies. This product may contain inactive ingredients (such as||
1597|120|P|benzyl benzoate, refined castor oil), which can cause allergic||
1597|121|P|reactions or other problems. Talk to your pharmacist for more||
1597|122|P|details.||
1597|123|P|   Before using this medication, tell your doctor or pharmacist||
1597|124|P|your medical history, especially of: cancer (especially prostate||
1597|125|P|or breast cancer), prostate problems (such as enlarged prostate),||
1597|126|P|heart problems (such as heart failure, previous heart attack),||
1597|127|P|stroke, kidney problems, liver problems, high blood pressure,||
1597|128|P|high cholesterol, difficulty breathing during sleep (sleep||
1597|129|P|apnea), blood clots (such as in the leg, lungs).||
1597|130|P|   If you have diabetes, this product may lower your blood sugar.||
1597|131|P|Check your blood sugar regularly as directed and share the||
1597|132|P|results with your doctor. Tell your doctor right away if you have||
1597|133|P|symptoms of low blood sugar, such as sudden sweating, shaking,||
1597|134|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
1597|135|P|hands/feet. Your doctor may need to adjust your diabetes||
1597|136|P|medication, exercise program, or diet.||
1597|137|P|   Before having surgery, tell your doctor or dentist about all||
1597|138|P|the products you use (including prescription drugs,||
1597|139|P|nonprescription drugs, and herbal products).||
1597|140|P|   Children may be more sensitive to the side effects of this||
1597|141|P|drug. In children, it may affect bone growth. Check your child's||
1597|142|P|height periodically.||
1597|143|P|   Some men, particularly older adults, are at a higher risk for||
1597|144|P|developing enlarged prostate or prostate cancer while using this||
1597|145|P|medication. Your risk of prostate problems should be checked by||
1597|146|P|your doctor before you start testosterone.||
1597|147|P|   This medication can affect fertility in males. Ask your doctor||
1597|148|P|for more details.||
1597|149|P|   This medication should not be used in women, especially during||
1597|150|P|pregnancy or breastfeeding. It may harm an unborn or||
1597|151|P|breastfeeding baby. Consult your doctor for more details.||
1597|152|B|||
1597|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1597|154|I|medications work or increase your risk for serious side effects.||
1597|155|I|This document does not contain all possible drug interactions.||
1597|156|I|Keep a list of all the products you use (including||
1597|157|I|prescription/nonprescription drugs and herbal products) and share||
1597|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
1597|159|I|the dosage of any medicines without your doctor's approval.||
1597|160|I|   Some products that may interact with this drug include: "blood||
1597|161|I|thinners" (such as warfarin).||
1597|162|I|   This medication may interfere with certain lab tests (such as||
1597|163|I|thyroid tests), possibly causing false test results. Make sure||
1597|164|I|lab personnel and all your doctors know you use this drug.||
1597|165|B|||
1597|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1597|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1597|168|O|poison control center right away. US residents can call||
1597|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1597|170|B|||
1597|171|N|NOTES:  Lab and/or medical tests (such as testosterone levels,||
1597|172|N|blood cell counts, liver function, cholesterol levels, PSA)||
1597|173|N|should be done before you start using this medication and while||
1597|174|N|you are using it. Keep all medical and lab appointments. Consult||
1597|175|N|your doctor for more details.||
1597|176|B|||
1597|177|D|MISSED DOSE:  It is important to get each dose of this medication||
1597|178|D|as scheduled. If you miss a dose, ask your doctor right away for||
1597|179|D|a new dosing schedule.||
1597|180|B|||
1597|181|R|STORAGE:  Not applicable. This medication is given in a hospital||
1597|182|R|or clinic or doctor's office and will not be stored at home.||
1597|183|B|||
1597|184|A|Information last revised March 2025.||
1597|185|A|Copyright(c) 2025 First Databank, Inc.||
1597|186|B|||
1598|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1598|002|Z|does NOT have all possible information about this product. This||
1598|003|Z|information does not assure that this product is safe, effective,||
1598|004|Z|or appropriate for you. This information is not individual||
1598|005|Z|medical advice and does not substitute for the advice of your||
1598|006|Z|health care professional. Always ask your health care||
1598|007|Z|professional for complete information about this product and your||
1598|008|Z|specific health needs.||
1598|009|B|||
1598|010|T|POSACONAZOLE DELAYED-RELEASE - ORAL||
1598|011|F|(POE-sa-KON-a-zole)||
1598|012|B|||
1598|013|C|COMMON BRAND NAME(S): Noxafil||
1598|014|B|||
1598|015|U|USES:  Posaconazole is used to prevent certain fungal infections||
1598|016|U|in patients who have severely weakened immune systems (such as||
1598|017|U|patients who have had chemotherapy). It belongs to a class of||
1598|018|U|drugs known as azole antifungals. It works by stopping the growth||
1598|019|U|of fungi.||
1598|020|B|||
1598|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1598|022|H|from your pharmacist before you start taking posaconazole and||
1598|023|H|each time you get a refill. If you have any questions, ask your||
1598|024|H|doctor or pharmacist.||
1598|025|H|   Take this medication by mouth with or without food as directed||
1598|026|H|by your doctor, usually once daily. Do not crush or chew||
1598|027|H|delayed-release tablets. Doing so can release all of the drug at||
1598|028|H|once, increasing the risk of side effects. Swallow the whole||
1598|029|H|tablet without crushing or chewing.||
1598|030|H|   The length of treatment is based on your medical condition.||
1598|031|H|   This medication works best when the amount of medicine in your||
1598|032|H|body is kept at a constant level. Take this drug at evenly spaced||
1598|033|H|intervals.||
1598|034|H|   The tablet and suspension forms of posaconazole may deliver||
1598|035|H|different amounts of medication. Do not switch between the||
1598|036|H|different forms of this medication without your doctor's||
1598|037|H|permission and directions.||
1598|038|H|   Tell your doctor if you have severe diarrhea or vomiting.||
1598|039|H|Posaconazole may not work as well.||
1598|040|B|||
1598|041|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, abdominal||
1598|042|S|pain, dizziness, trouble sleeping, or stomach upset may occur. If||
1598|043|S|any of these effects last or get worse, tell your doctor or||
1598|044|S|pharmacist promptly.||
1598|045|S|   Remember that this medication has been prescribed because your||
1598|046|S|doctor has judged that the benefit to you is greater than the||
1598|047|S|risk of side effects. Many people using this medication do not||
1598|048|S|have serious side effects.||
1598|049|S|   This medication may raise your blood pressure. Check your||
1598|050|S|blood pressure regularly and tell your doctor if the results are||
1598|051|S|high.||
1598|052|S|   Tell your doctor right away if you have any serious side||
1598|053|S|effects, including: unusual tiredness, easy bruising/bleeding,||
1598|054|S|weakness, muscle cramps, mental/mood changes, swelling of the||
1598|055|S|ankles/feet, signs of infection (such as sore throat that doesn't||
1598|056|S|go away, chills, fever), vaginal bleeding, shortness of breath,||
1598|057|S|increased thirst/urination.||
1598|058|S|   Get medical help right away if you have any very serious side||
1598|059|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1598|060|S|fainting.||
1598|061|S|   Posaconazole has rarely caused very serious (possibly fatal)||
1598|062|S|liver disease. Tell your doctor right away if you develop||
1598|063|S|symptoms of liver disease, including: nausea/vomiting that||
1598|064|S|doesn't stop, yellowing eyes/skin, dark urine, severe||
1598|065|S|stomach/abdominal pain.||
1598|066|S|   A very serious allergic reaction to this drug is rare.||
1598|067|S|However, get medical help right away if you notice any symptoms||
1598|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1598|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1598|070|S|breathing.||
1598|071|S|   Posaconazole can commonly cause a mild rash that is usually||
1598|072|S|not serious. However, you may not be able to tell it apart from a||
1598|073|S|rare rash that could be a sign of a severe allergic reaction. Get||
1598|074|S|medical help right away if you develop any rash.||
1598|075|S|   This is not a complete list of possible side effects. If you||
1598|076|S|notice other effects not listed above, contact your doctor or||
1598|077|S|pharmacist.||
1598|078|S|   In the US -||
1598|079|S|   Call your doctor for medical advice about side effects. You||
1598|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1598|081|S|www.fda.gov/medwatch.||
1598|082|S|   In Canada - Call your doctor for medical advice about side||
1598|083|S|effects. You may report side effects to Health Canada at||
1598|084|S|1-866-234-2345.||
1598|085|B|||
1598|086|P|PRECAUTIONS:  Before taking posaconazole, tell your doctor or||
1598|087|P|pharmacist if you are allergic to it; or to other azole||
1598|088|P|antifungals (such as ketoconazole); or if you have any other||
1598|089|P|allergies. This product may contain inactive ingredients, which||
1598|090|P|can cause allergic reactions or other problems. Talk to your||
1598|091|P|pharmacist for more details.||
1598|092|P|   Before using this medication, tell your doctor or pharmacist||
1598|093|P|your medical history, especially of: liver disease, kidney||
1598|094|P|disease.||
1598|095|P|   Posaconazole may cause a condition that affects the heart||
1598|096|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1598|097|P|serious (rarely fatal) fast/irregular heartbeat and other||
1598|098|P|symptoms (such as severe dizziness, fainting) that need medical||
1598|099|P|attention right away.||
1598|100|P|   The risk of QT prolongation may be increased if you have||
1598|101|P|certain medical conditions or are taking other drugs that may||
1598|102|P|cause QT prolongation. Before using posaconazole, tell your||
1598|103|P|doctor or pharmacist of all the drugs you take and if you have||
1598|104|P|any of the following conditions: certain heart problems (heart||
1598|105|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1598|106|P|history of certain heart problems (QT prolongation in the EKG,||
1598|107|P|sudden cardiac death).||
1598|108|P|   Low levels of potassium or magnesium in the blood may also||
1598|109|P|increase your risk of QT prolongation. This risk may increase if||
1598|110|P|you use certain drugs (such as diuretics/"water pills") or if you||
1598|111|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1598|112|P|Talk to your doctor about using posaconazole safely.||
1598|113|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1598|114|P|can make you more dizzy. Do not drive, use machinery, or do||
1598|115|P|anything that needs alertness until you can do it safely. Avoid||
1598|116|P|alcoholic beverages. Talk to your doctor if you are using||
1598|117|P|marijuana (cannabis). Alcohol may also increase the risk of||
1598|118|P|serious liver problems.||
1598|119|P|   Before having surgery, tell your doctor or dentist about all||
1598|120|P|the products you use (including prescription drugs,||
1598|121|P|nonprescription drugs, and herbal products).||
1598|122|P|   Older adults may be more sensitive to the side effects of this||
1598|123|P|drug, especially QT prolongation (see above).||
1598|124|P|   During pregnancy, this medication should be used only when||
1598|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
1598|126|P|   It is unknown if this drug passes into breast milk. Consult||
1598|127|P|your doctor before breastfeeding.||
1598|128|B|||
1598|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1598|130|I|medications work or increase your risk for serious side effects.||
1598|131|I|This document does not contain all possible drug interactions.||
1598|132|I|Keep a list of all the products you use (including||
1598|133|I|prescription/nonprescription drugs and herbal products) and share||
1598|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
1598|135|I|the dosage of any medicines without your doctor's approval.||
1598|136|I|   Other medications can affect the removal of posaconazole from||
1598|137|I|your body, which may affect how posaconazole works. Examples||
1598|138|I|include efavirenz, rifamycins (such as rifabutin), certain drugs||
1598|139|I|used to treat seizures (such as phenytoin), among others.||
1598|140|I|   This drug can slow down the removal of other drugs from your||
1598|141|I|body, which may affect how they work. Examples of affected drugs||
1598|142|I|include certain alpha blockers (such as alfuzosin, silodosin,||
1598|143|I|tamsulosin), certain benzodiazepines (such as midazolam),||
1598|144|I|dronedarone, ergot alkaloids (such as ergotamine,||
1598|145|I|dihydroergotamine), pimozide, quinidine, rivaroxaban, sirolimus,||
1598|146|I|certain "statin" drugs (such as lovastatin, simvastatin),||
1598|147|I|venetoclax, among others.||
1598|148|I|   Many drugs besides posaconazole may affect the heart rhythm||
1598|149|I|(QT prolongation), including pacritinib, among others.||
1598|150|B|||
1598|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1598|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1598|153|O|poison control center right away. US residents can call||
1598|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1598|155|B|||
1598|156|N|NOTES:  Do not share this medication with others.||
1598|157|N|   This medication has been prescribed for your current condition||
1598|158|N|only. Do not use it later to prevent another infection unless||
1598|159|N|your doctor tells you to.||
1598|160|N|   Lab and/or medical tests (such as liver function, blood||
1598|161|N|pressure, blood mineral levels such as calcium, magnesium,||
1598|162|N|potassium) should be done before you start using this medication||
1598|163|N|and while you are using it. Keep all medical and lab||
1598|164|N|appointments. Consult your doctor for more details.||
1598|165|B|||
1598|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1598|167|D|remember. If it is within 12 hours of the next dose, skip the||
1598|168|D|missed dose. Take your next dose at the regular time. Do not||
1598|169|D|double the dose to catch up.||
1598|170|B|||
1598|171|R|STORAGE:  Store at room temperature away from light and moisture.||
1598|172|R|Do not store in the bathroom. Keep all medications away from||
1598|173|R|children and pets.||
1598|174|R|   Do not flush medications down the toilet or pour them into a||
1598|175|R|drain unless instructed to do so. Properly discard this product||
1598|176|R|when it is expired or no longer needed. Consult your pharmacist||
1598|177|R|or local waste disposal company.||
1598|178|B|||
1598|179|A|Information last revised April 2025.||
1598|180|A|Copyright(c) 2025 First Databank, Inc.||
1598|181|B|||
1599|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1599|002|Z|does NOT have all possible information about this product. This||
1599|003|Z|information does not assure that this product is safe, effective,||
1599|004|Z|or appropriate for you. This information is not individual||
1599|005|Z|medical advice and does not substitute for the advice of your||
1599|006|Z|health care professional. Always ask your health care||
1599|007|Z|professional for complete information about this product and your||
1599|008|Z|specific health needs.||
1599|009|B|||
1599|010|T|APREMILAST - ORAL||
1599|011|F|(a-PRE-mi-last)||
1599|012|B|||
1599|013|C|COMMON BRAND NAME(S): Otezla||
1599|014|B|||
1599|015|U|USES:  This medication is used to treat a certain type of||
1599|016|U|arthritis (psoriatic arthritis). Apremilast is also used to treat||
1599|017|U|a certain type of skin condition (moderate to severe plaque||
1599|018|U|psoriasis). Apremilast belongs to a class of drugs known as||
1599|019|U|phosphodiesterase 4 (PDE4) inhibitors. For the treatment of||
1599|020|U|psoriatic arthritis, it decreases pain and swelling, and may help||
1599|021|U|improve flexibility in the affected joints. For the treatment of||
1599|022|U|plaque psoriasis, it may help to reduce the redness, thickening,||
1599|023|U|and scaling of the skin that occurs with this condition.||
1599|024|U|   Apremilast is also used to treat mouth sores in people who||
1599|025|U|have Behcet's disease. It helps to reduce the pain and improve||
1599|026|U|the healing of these mouth sores.||
1599|027|B|||
1599|028|H|HOW TO USE:  Take this medication by mouth with or without food||
1599|029|H|as directed by your doctor, usually twice daily. The manufacturer||
1599|030|H|directs not to crush, split, or chew the tablet before taking it.||
1599|031|H|However, many similar drugs (immediate-release tablets) can be||
1599|032|H|crushed, split, or chewed. Follow your doctor's directions on how||
1599|033|H|to take this medication.||
1599|034|H|   The dosage is based on your medical condition and response to||
1599|035|H|treatment. Children's dosage is also based on weight. To reduce||
1599|036|H|your risk of side effects, your doctor may direct you to start||
1599|037|H|this medication at a low dose and gradually increase your dose.||
1599|038|H|Follow your doctor's instructions carefully.||
1599|039|H|   Use this medication regularly to get the most benefit from it.||
1599|040|H|To help you remember, take it at the same times each day.||
1599|041|H|   Tell your doctor if your condition does not get better or if||
1599|042|H|it gets worse.||
1599|043|B|||
1599|044|S|SIDE EFFECTS:  Diarrhea, nausea/vomiting, loss of appetite,||
1599|045|S|headache, or weight loss may occur. If any of these effects last||
1599|046|S|or get worse, tell your doctor or pharmacist promptly.||
1599|047|S|   Remember that this medication has been prescribed because your||
1599|048|S|doctor has judged that the benefit to you is greater than the||
1599|049|S|risk of side effects. Many people using this medication do not||
1599|050|S|have serious side effects.||
1599|051|S|   Tell your doctor right away if you have any serious side||
1599|052|S|effects, including: severe nausea/vomiting/diarrhea.||
1599|053|S|   Rarely, people who take this medication may experience||
1599|054|S|depression, suicidal thoughts/attempts, or other mental/mood||
1599|055|S|problems. Tell your doctor right away if you or your||
1599|056|S|family/caregiver notice any unusual/sudden changes in your mood,||
1599|057|S|thoughts, or behavior including signs of depression, suicidal||
1599|058|S|thoughts/attempts, thoughts about harming yourself.||
1599|059|S|   A very serious allergic reaction to this drug is rare.||
1599|060|S|However, get medical help right away if you notice any symptoms||
1599|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1599|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1599|063|S|breathing.||
1599|064|S|   This is not a complete list of possible side effects. If you||
1599|065|S|notice other effects not listed above, contact your doctor or||
1599|066|S|pharmacist.||
1599|067|S|   In the US -||
1599|068|S|   Call your doctor for medical advice about side effects. You||
1599|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1599|070|S|www.fda.gov/medwatch.||
1599|071|S|   In Canada - Call your doctor for medical advice about side||
1599|072|S|effects. You may report side effects to Health Canada at||
1599|073|S|1-866-234-2345.||
1599|074|B|||
1599|075|P|PRECAUTIONS:  Before taking apremilast, tell your doctor or||
1599|076|P|pharmacist if you are allergic to it; or if you have any other||
1599|077|P|allergies. This product may contain inactive ingredients, which||
1599|078|P|can cause allergic reactions or other problems. Talk to your||
1599|079|P|pharmacist for more details.||
1599|080|P|   Before using this medication, tell your doctor or pharmacist||
1599|081|P|your medical history, especially of: kidney disease, mental/mood||
1599|082|P|disorders (such as depression).||
1599|083|P|   Before having surgery, tell your doctor or dentist about all||
1599|084|P|the products you use (including prescription drugs,||
1599|085|P|nonprescription drugs, and herbal products).||
1599|086|P|   During pregnancy, this medication should be used only when||
1599|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
1599|088|P|   It is unknown if this medication passes into breast milk.||
1599|089|P|Consult your doctor before breastfeeding.||
1599|090|B|||
1599|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1599|092|I|medications work or increase your risk for serious side effects.||
1599|093|I|This document does not contain all possible drug interactions.||
1599|094|I|Keep a list of all the products you use (including||
1599|095|I|prescription/nonprescription drugs and herbal products) and share||
1599|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
1599|097|I|the dosage of any medicines without your doctor's approval.||
1599|098|I|   Other medications can affect the removal of apremilast from||
1599|099|I|your body, which may affect how apremilast works. Examples||
1599|100|I|include certain drugs used to treat seizures (such as||
1599|101|I|carbamazepine, phenobarbital, phenytoin, primidone), rifamycins||
1599|102|I|(such as rifampin, rifabutin), among others.||
1599|103|B|||
1599|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1599|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1599|106|O|poison control center right away. US residents can call||
1599|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1599|108|B|||
1599|109|N|NOTES:  Do not share this medication with others.||
1599|110|N|   Since this medication can cause weight loss, check your weight||
1599|111|N|regularly while taking this drug. Tell your doctor of any unusual||
1599|112|N|weight loss. Children should also see their doctor regularly so||
1599|113|N|that their height, weight, and growth can be checked.||
1599|114|B|||
1599|115|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1599|116|D|remember. If it is near the time of the next dose, skip the||
1599|117|D|missed dose. Take your next dose at the regular time. Do not||
1599|118|D|double the dose to catch up.||
1599|119|B|||
1599|120|R|STORAGE:  Store at room temperature away from light and moisture.||
1599|121|R|Do not store in the bathroom. Keep all medications away from||
1599|122|R|children and pets.||
1599|123|R|   Do not flush medications down the toilet or pour them into a||
1599|124|R|drain unless instructed to do so. Properly discard this product||
1599|125|R|when it is expired or no longer needed. Consult your pharmacist||
1599|126|R|or local waste disposal company.||
1599|127|B|||
1599|128|A|Information last revised October 2024.||
1599|129|A|Copyright(c) 2025 First Databank, Inc.||
1599|130|B|||
1601|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1601|002|Z|does NOT have all possible information about this product. This||
1601|003|Z|information does not assure that this product is safe, effective,||
1601|004|Z|or appropriate for you. This information is not individual||
1601|005|Z|medical advice and does not substitute for the advice of your||
1601|006|Z|health care professional. Always ask your health care||
1601|007|Z|professional for complete information about this product and your||
1601|008|Z|specific health needs.||
1601|009|B|||
1601|010|T|POSACONAZOLE - INJECTION||
1601|011|F|(POE-sa-KON-a-zole)||
1601|012|B|||
1601|013|C|COMMON BRAND NAME(S): Noxafil||
1601|014|B|||
1601|015|U|USES:  Posaconazole is used to prevent certain fungal infections||
1601|016|U|in patients who have severely weakened immune systems (such as||
1601|017|U|patients who have had chemotherapy). It belongs to a class of||
1601|018|U|drugs known as azole antifungals. It works by stopping the growth||
1601|019|U|of fungi.||
1601|020|B|||
1601|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1601|022|H|from your pharmacist before you start using posaconazole and each||
1601|023|H|time you get a refill. If you have any questions, ask your doctor||
1601|024|H|or pharmacist.||
1601|025|H|   This medication is given by injection into a vein as directed||
1601|026|H|by your doctor, usually once daily. It should be injected slowly||
1601|027|H|over 90 minutes.||
1601|028|H|   If you are giving this medication to yourself at home, learn||
1601|029|H|all preparation and usage instructions from your health care||
1601|030|H|professional. Before using, check this product for particles or||
1601|031|H|discoloration. If either is present, do not use the liquid. Learn||
1601|032|H|how to store and discard medical supplies safely.||
1601|033|H|   The length of treatment is based on your medical condition.||
1601|034|H|   This medication works best when the amount of medicine in your||
1601|035|H|body is kept at a constant level. Use this drug at evenly spaced||
1601|036|H|intervals.||
1601|037|B|||
1601|038|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, abdominal||
1601|039|S|pain, dizziness, or trouble sleeping may occur. If any of these||
1601|040|S|effects last or get worse, tell your doctor or pharmacist||
1601|041|S|promptly.||
1601|042|S|   Remember that this medication has been prescribed because your||
1601|043|S|doctor has judged that the benefit to you is greater than the||
1601|044|S|risk of side effects. Many people using this medication do not||
1601|045|S|have serious side effects.||
1601|046|S|   This medication may raise your blood pressure. Check your||
1601|047|S|blood pressure regularly and tell your doctor if the results are||
1601|048|S|high.||
1601|049|S|   Tell your doctor right away if you have any serious side||
1601|050|S|effects, including: unusual tiredness, easy bruising/bleeding,||
1601|051|S|weakness, muscle cramps, mental/mood changes, swelling of the||
1601|052|S|ankles/feet, signs of infection (such as sore throat that doesn't||
1601|053|S|go away, chills, fever), vaginal bleeding, shortness of breath,||
1601|054|S|increased thirst/urination.||
1601|055|S|   Get medical help right away if you have any very serious side||
1601|056|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1601|057|S|fainting.||
1601|058|S|   Posaconazole has rarely caused very serious (possibly fatal)||
1601|059|S|liver disease. Tell your doctor right away if you develop||
1601|060|S|symptoms of liver disease, including: nausea/vomiting that||
1601|061|S|doesn't stop, yellowing eyes/skin, dark urine, severe||
1601|062|S|stomach/abdominal pain.||
1601|063|S|   A very serious allergic reaction to this drug is rare.||
1601|064|S|However, get medical help right away if you notice any symptoms||
1601|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1601|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1601|067|S|breathing.||
1601|068|S|   Posaconazole can commonly cause a mild rash that is usually||
1601|069|S|not serious. However, you may not be able to tell it apart from a||
1601|070|S|rare rash that could be a sign of a severe allergic reaction. Get||
1601|071|S|medical help right away if you develop any rash.||
1601|072|S|   This is not a complete list of possible side effects. If you||
1601|073|S|notice other effects not listed above, contact your doctor or||
1601|074|S|pharmacist.||
1601|075|S|   In the US -||
1601|076|S|   Call your doctor for medical advice about side effects. You||
1601|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1601|078|S|www.fda.gov/medwatch.||
1601|079|S|   In Canada - Call your doctor for medical advice about side||
1601|080|S|effects. You may report side effects to Health Canada at||
1601|081|S|1-866-234-2345.||
1601|082|B|||
1601|083|P|PRECAUTIONS:  Before using posaconazole, tell your doctor or||
1601|084|P|pharmacist if you are allergic to it; or to other azole||
1601|085|P|antifungals (such as ketoconazole); or if you have any other||
1601|086|P|allergies. This product may contain inactive ingredients, which||
1601|087|P|can cause allergic reactions or other problems. Talk to your||
1601|088|P|pharmacist for more details.||
1601|089|P|   Before using this medication, tell your doctor or pharmacist||
1601|090|P|your medical history, especially of: liver disease, kidney||
1601|091|P|disease.||
1601|092|P|   Posaconazole may cause a condition that affects the heart||
1601|093|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1601|094|P|serious (rarely fatal) fast/irregular heartbeat and other||
1601|095|P|symptoms (such as severe dizziness, fainting) that need medical||
1601|096|P|attention right away.||
1601|097|P|   The risk of QT prolongation may be increased if you have||
1601|098|P|certain medical conditions or are taking other drugs that may||
1601|099|P|cause QT prolongation. Before using posaconazole, tell your||
1601|100|P|doctor or pharmacist of all the drugs you take and if you have||
1601|101|P|any of the following conditions: certain heart problems (heart||
1601|102|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1601|103|P|history of certain heart problems (QT prolongation in the EKG,||
1601|104|P|sudden cardiac death).||
1601|105|P|   Low levels of potassium or magnesium in the blood may also||
1601|106|P|increase your risk of QT prolongation. This risk may increase if||
1601|107|P|you use certain drugs (such as diuretics/"water pills") or if you||
1601|108|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1601|109|P|Talk to your doctor about using posaconazole safely.||
1601|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1601|111|P|can make you more dizzy. Do not drive, use machinery, or do||
1601|112|P|anything that needs alertness until you can do it safely. Avoid||
1601|113|P|alcoholic beverages. Talk to your doctor if you are using||
1601|114|P|marijuana (cannabis). Alcohol may also increase the risk of||
1601|115|P|serious liver problems.||
1601|116|P|   Before having surgery, tell your doctor or dentist about all||
1601|117|P|the products you use (including prescription drugs,||
1601|118|P|nonprescription drugs, and herbal products).||
1601|119|P|   Older adults may be more sensitive to the side effects of this||
1601|120|P|drug, especially QT prolongation (see above).||
1601|121|P|   During pregnancy, this medication should be used only when||
1601|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
1601|123|P|   It is unknown if this drug passes into breast milk. Consult||
1601|124|P|your doctor before breastfeeding.||
1601|125|B|||
1601|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1601|127|I|medications work or increase your risk for serious side effects.||
1601|128|I|This document does not contain all possible drug interactions.||
1601|129|I|Keep a list of all the products you use (including||
1601|130|I|prescription/nonprescription drugs and herbal products) and share||
1601|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
1601|132|I|the dosage of any medicines without your doctor's approval.||
1601|133|I|   Other medications can affect the removal of posaconazole from||
1601|134|I|your body, which may affect how posaconazole works. Examples||
1601|135|I|include efavirenz, rifamycins (such as rifabutin), certain drugs||
1601|136|I|used to treat seizures (such as phenytoin), among others.||
1601|137|I|   This drug can slow down the removal of other drugs from your||
1601|138|I|body, which may affect how they work. Examples of affected drugs||
1601|139|I|include certain alpha blockers (such as alfuzosin, silodosin,||
1601|140|I|tamsulosin), certain benzodiazepines (such as midazolam),||
1601|141|I|dronedarone, ergot alkaloids (such as ergotamine,||
1601|142|I|dihydroergotamine), pimozide, quinidine, rivaroxaban, sirolimus,||
1601|143|I|certain "statin" drugs (such as simvastatin, lovastatin),||
1601|144|I|venetoclax, among others.||
1601|145|I|   Many drugs besides posaconazole may affect the heart rhythm||
1601|146|I|(QT prolongation), including pacritinib, among others.||
1601|147|B|||
1601|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1601|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1601|150|O|poison control center right away. US residents can call||
1601|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1601|152|B|||
1601|153|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
1601|154|N|blood pressure, blood mineral levels such as calcium, magnesium,||
1601|155|N|potassium) should be done before you start using this medication||
1601|156|N|and while you are using it. Keep all medical and lab||
1601|157|N|appointments. Consult your doctor for more details.||
1601|158|B|||
1601|159|D|MISSED DOSE:  It is important to get each dose of this medication||
1601|160|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1601|161|D|right away for a new dosing schedule. Do not double the dose to||
1601|162|D|catch up.||
1601|163|B|||
1601|164|R|STORAGE:  Consult the product instructions and your pharmacist||
1601|165|R|for storage details. Keep all medications away from children and||
1601|166|R|pets.||
1601|167|R|   Do not flush medications down the toilet or pour them into a||
1601|168|R|drain unless instructed to do so. Properly discard this product||
1601|169|R|when it is expired or no longer needed. Consult your pharmacist||
1601|170|R|or local waste disposal company.||
1601|171|B|||
1601|172|A|Information last revised April 2025.||
1601|173|A|Copyright(c) 2025 First Databank, Inc.||
1601|174|B|||
1602|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1602|002|Z|does NOT have all possible information about this product. This||
1602|003|Z|information does not assure that this product is safe, effective,||
1602|004|Z|or appropriate for you. This information is not individual||
1602|005|Z|medical advice and does not substitute for the advice of your||
1602|006|Z|health care professional. Always ask your health care||
1602|007|Z|professional for complete information about this product and your||
1602|008|Z|specific health needs.||
1602|009|B|||
1602|010|T|TREPROSTINIL EXTENDED-RELEASE - ORAL||
1602|011|F|(tre-PROS-ti-nil)||
1602|012|B|||
1602|013|C|COMMON BRAND NAME(S): Orenitram ER||
1602|014|B|||
1602|015|U|USES:  This medication is used to treat a type of high blood||
1602|016|U|pressure in the lungs (pulmonary arterial hypertension).||
1602|017|U|Treprostinil helps to delay disease worsening and increase your||
1602|018|U|ability to exercise. It works by relaxing and widening the blood||
1602|019|U|vessels (arteries) in the lungs and other parts of the body so||
1602|020|U|that blood can flow more easily. This medication belongs to a||
1602|021|U|class of drugs known as vasodilators.||
1602|022|B|||
1602|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1602|024|H|from your pharmacist before you start taking treprostinil and||
1602|025|H|each time you get a refill. If you have any questions, ask your||
1602|026|H|doctor or pharmacist.||
1602|027|H|   Take this medication by mouth with food as directed by your||
1602|028|H|doctor, usually twice daily (every 12 hours) or three times daily||
1602|029|H|(every 8 hours).||
1602|030|H|   Swallow the medication whole. Do not crush or chew the tablets||
1602|031|H|or use a tablet that is damaged or broken. Doing so can release||
1602|032|H|all of the drug at once, increasing the risk of side effects.||
1602|033|H|   The dosage is based on your medical condition, response to||
1602|034|H|treatment, and other medications you may be taking. Be sure to||
1602|035|H|tell your doctor and pharmacist about all the products you use||
1602|036|H|(including prescription drugs, nonprescription drugs, and herbal||
1602|037|H|products). To reduce your risk of side effects, your doctor may||
1602|038|H|direct you to start this medication at a low dose and gradually||
1602|039|H|increase your dose. Follow your doctor's instructions carefully.||
1602|040|H|   Use this medication regularly to get the most benefit from it.||
1602|041|H|Remember to take it at the same times each day. Do not stop||
1602|042|H|taking this medication without consulting your doctor. Your||
1602|043|H|condition may become worse when this drug is suddenly stopped.||
1602|044|H|Your dose may need to be gradually decreased.||
1602|045|H|   Your doctor may direct you to use other medications in||
1602|046|H|addition to treprostinil to treat your condition and to prevent||
1602|047|H|problems. Use all prescribed medications exactly as directed.||
1602|048|H|   Tell your doctor if your condition does not get better or if||
1602|049|H|it gets worse.||
1602|050|B|||
1602|051|S|SIDE EFFECTS:  Headache, nausea, diarrhea, jaw pain, flushing,||
1602|052|S|dizziness, and abdominal pain may occur. If any of these effects||
1602|053|S|last or get worse, tell your doctor or pharmacist promptly.||
1602|054|S|   An empty tablet shell may appear in your stool. This effect is||
1602|055|S|harmless because your body has already absorbed the medication.||
1602|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
1602|057|S|slowly when rising from a sitting or lying position.||
1602|058|S|   Remember that this medication has been prescribed because your||
1602|059|S|doctor has judged that the benefit to you is greater than the||
1602|060|S|risk of side effects. Many people using this medication do not||
1602|061|S|have serious side effects.||
1602|062|S|   Tell your doctor right away if you have any serious side||
1602|063|S|effects, including: muscle cramps, weakness, unusual||
1602|064|S|bleeding/bruising.||
1602|065|S|   A very serious allergic reaction to this drug is rare.||
1602|066|S|However, get medical help right away if you notice any symptoms||
1602|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1602|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1602|069|S|breathing.||
1602|070|S|   This is not a complete list of possible side effects. If you||
1602|071|S|notice other effects not listed above, contact your doctor or||
1602|072|S|pharmacist.||
1602|073|S|   In the US -||
1602|074|S|   Call your doctor for medical advice about side effects. You||
1602|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1602|076|S|www.fda.gov/medwatch.||
1602|077|S|   In Canada - Call your doctor for medical advice about side||
1602|078|S|effects. You may report side effects to Health Canada at||
1602|079|S|1-866-234-2345.||
1602|080|B|||
1602|081|P|PRECAUTIONS:  Before using treprostinil, tell your doctor or||
1602|082|P|pharmacist if you are allergic to it; or if you have any other||
1602|083|P|allergies. This product may contain inactive ingredients, which||
1602|084|P|can cause allergic reactions or other problems. Talk to your||
1602|085|P|pharmacist for more details.||
1602|086|P|   Before using this medication, tell your doctor or pharmacist||
1602|087|P|your medical history, especially of: liver disease, bleeding||
1602|088|P|problems, a certain intestinal disorder (diverticulosis).||
1602|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1602|090|P|can make you more dizzy. Do not drive, use machinery, or do||
1602|091|P|anything that needs alertness until you can do it safely. Limit||
1602|092|P|alcoholic beverages. Talk to your doctor if you are using||
1602|093|P|marijuana (cannabis).||
1602|094|P|   Before having surgery, tell your doctor or dentist about all||
1602|095|P|the products you use (including prescription drugs,||
1602|096|P|nonprescription drugs, and herbal products).||
1602|097|P|   During pregnancy, this medication should be used only when||
1602|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
1602|099|P|    This medication passes into breast milk. Consult your doctor||
1602|100|P|before breastfeeding.||
1602|101|B|||
1602|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1602|103|I|medications work or increase your risk for serious side effects.||
1602|104|I|This document does not contain all possible drug interactions.||
1602|105|I|Keep a list of all the products you use (including||
1602|106|I|prescription/nonprescription drugs and herbal products) and share||
1602|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1602|108|I|the dosage of any medicines without your doctor's approval.||
1602|109|B|||
1602|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1602|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1602|112|O|poison control center right away. US residents can call||
1602|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1602|114|O|Symptoms of overdose may include: severe dizziness, fainting.||
1602|115|B|||
1602|116|N|NOTES:  Do not share this medication with others.||
1602|117|N|   Lab and/or medical tests (such as blood pressure) may be done||
1602|118|N|while you are taking this medication. Keep all medical and lab||
1602|119|N|appointments. Consult your doctor for more details.||
1602|120|B|||
1602|121|D|MISSED DOSE:  If you miss a dose, take it with food as soon as||
1602|122|D|you remember. If it is near the time of the next dose, skip the||
1602|123|D|missed dose. Take your next dose at the regular time. Do not||
1602|124|D|double the dose to catch up. If you miss 2 or more doses, ask||
1602|125|D|your doctor how to safely restart the medication.||
1602|126|B|||
1602|127|R|STORAGE:  Store at room temperature away from light and moisture.||
1602|128|R|Do not store in the bathroom. Keep all medications away from||
1602|129|R|children and pets.||
1602|130|R|   Do not flush medications down the toilet or pour them into a||
1602|131|R|drain unless instructed to do so. Properly discard this product||
1602|132|R|when it is expired or no longer needed. Consult your pharmacist||
1602|133|R|or local waste disposal company.||
1602|134|B|||
1602|135|A|Information last revised August 2025.||
1602|136|A|Copyright(c) 2025 First Databank, Inc.||
1602|137|B|||
1603|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1603|002|Z|does NOT have all possible information about this product. This||
1603|003|Z|information does not assure that this product is safe, effective,||
1603|004|Z|or appropriate for you. This information is not individual||
1603|005|Z|medical advice and does not substitute for the advice of your||
1603|006|Z|health care professional. Always ask your health care||
1603|007|Z|professional for complete information about this product and your||
1603|008|Z|specific health needs.||
1603|009|B|||
1603|010|T|MENINGOCOCCAL VACCINE - INJECTION||
1603|011|F|(MEN-in-go-COC-al)||
1603|012|B|||
1603|013|C|COMMON BRAND NAME(S): Menactra, Menveo, Penmenvy, Trumenba||
1603|014|B|||
1603|015|U|USES:  This vaccine is used to help prevent certain serious,||
1603|016|U|sometimes fatal, bacterial infections (meningitis,||
1603|017|U|meningococcemia). These infections may cause severe problems||
1603|018|U|(hearing loss, brain/nerve problems, paralysis, blindness,||
1603|019|U|seizures, loss of limbs), even with antibiotic treatment.||
1603|020|U|Vaccination is the best way to protect against these||
1603|021|U|life-threatening infections. This vaccine works by increasing the||
1603|022|U|body's natural defense (immunity) against the bacteria.||
1603|023|U|   Vaccines may not fully protect everyone who receives them.||
1603|024|B|||
1603|025|H|HOW TO USE:  Read all vaccine information available from your||
1603|026|H|health care professional before receiving the vaccine. If you||
1603|027|H|have any questions, ask your health care professional.||
1603|028|H|   This vaccine is given by injection into a muscle by a health||
1603|029|H|care professional. It is given in the upper arm for children and||
1603|030|H|adults and in the thigh for infants. Depending on your age, the||
1603|031|H|vaccine is given one or more times. Closely follow the||
1603|032|H|vaccination schedule provided by the health care professional. To||
1603|033|H|help you remember, mark your calendar with a reminder.||
1603|034|B|||
1603|035|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
1603|036|S|headache, fever, chills, tiredness, joint/muscle pain, nausea,||
1603|037|S|loss of appetite, or diarrhea may occur. If any of these effects||
1603|038|S|last or get worse, tell your health care professional promptly.||
1603|039|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1603|040|S|vision changes, or ringing in the ears just after getting a||
1603|041|S|vaccine injection. Tell your health care professional right away||
1603|042|S|if you have any of these symptoms. Sitting or lying down may||
1603|043|S|help, since these symptoms usually don't last long.||
1603|044|S|   Remember that this vaccine has been prescribed because your||
1603|045|S|health care professional has judged that the benefit to you is||
1603|046|S|greater than the risk of side effects. Many people using this||
1603|047|S|vaccine do not have serious side effects.||
1603|048|S|   Tell your health care professional right away if you have any||
1603|049|S|serious side effects, including: numbness/tingling, muscle||
1603|050|S|weakness.||
1603|051|S|   A very serious allergic reaction to this vaccine is rare.||
1603|052|S|However, get medical help right away if you notice any symptoms||
1603|053|S|of a serious allergic reaction, including: rash, itching/swelling||
1603|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1603|055|S|breathing.||
1603|056|S|   This is not a complete list of possible side effects. If you||
1603|057|S|notice other effects not listed above, contact your health care||
1603|058|S|professional.||
1603|059|S|   Contact the health care professional for medical advice about||
1603|060|S|side effects. The following numbers do not provide medical||
1603|061|S|advice, but in the US you may report side effects to the Vaccine||
1603|062|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1603|063|S|Canada, you may call the Vaccine Safety Section at Public Health||
1603|064|S|Agency of Canada at 1-866-844-0018.||
1603|065|B|||
1603|066|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
1603|067|P|care professional if you are allergic to it; or if you have any||
1603|068|P|other allergies. This product may contain inactive ingredients||
1603|069|P|(such as latex found in some brands), which can cause allergic||
1603|070|P|reactions or other problems. Talk to your health care||
1603|071|P|professional for more details.||
1603|072|P|   Before receiving this vaccine, tell your health care||
1603|073|P|professional your medical history, especially of: current||
1603|074|P|fever/illness, a certain nerve disease (Guillain-Barre syndrome),||
1603|075|P|immune system disorders (such as due to HIV infection, certain||
1603|076|P|cancers such as leukemia/lymphoma, cancer or radiation||
1603|077|P|treatment), vaccination history (including previous reactions to||
1603|078|P|any vaccines).||
1603|079|P|   During pregnancy, this vaccine should be used only when||
1603|080|P|clearly needed. Discuss the risks and benefits with your health||
1603|081|P|care professional.||
1603|082|P|   It is unknown if this vaccine passes into breast milk. Consult||
1603|083|P|your health care professional before breastfeeding.||
1603|084|B|||
1603|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1603|086|I|medications work or increase your risk for serious side effects.||
1603|087|I|This document does not contain all possible drug interactions.||
1603|088|I|Keep a list of all the products you use (including||
1603|089|I|prescription/nonprescription drugs and herbal products) and share||
1603|090|I|it with your health care professional. Do not start, stop, or||
1603|091|I|change the dosage of any medicines without your doctor's||
1603|092|I|approval.||
1603|093|I|   Some products that may interact with this vaccine are: drugs||
1603|094|I|that weaken the immune system (including cyclosporine,||
1603|095|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1603|096|I|prednisone).||
1603|097|B|||
1603|098|O|OVERDOSE:  Not applicable.||
1603|099|B|||
1603|100|N|NOTES:  Keep all medical and lab appointments.||
1603|101|N|   Keep vaccine records for yourself and your children and||
1603|102|N|provide them to the health care professionals to prevent||
1603|103|N|unnecessary re-vaccinations.||
1603|104|B|||
1603|105|D|MISSED DOSE:  It is important that you get each vaccination as||
1603|106|D|scheduled. Ask when you should get each dose and mark your||
1603|107|D|calendar with a reminder. If you miss a dose, call the health||
1603|108|D|care professional to reschedule.||
1603|109|B|||
1603|110|R|STORAGE:  Store in the refrigerator. Do not freeze. Different||
1603|111|R|brands of this medication may have different storage needs. Check||
1603|112|R|the product package for instructions on how to store your brand,||
1603|113|R|or ask your pharmacist. Keep all medications away from children||
1603|114|R|and pets.||
1603|115|R|   Do not flush medications down the toilet or pour them into a||
1603|116|R|drain unless instructed to do so. Properly discard this product||
1603|117|R|when it is expired or no longer needed. Consult your pharmacist||
1603|118|R|or local waste disposal company.||
1603|119|B|||
1603|120|A|Information last revised February 2025.||
1603|121|A|Copyright(c) 2025 First Databank, Inc.||
1603|122|B|||
1605|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1605|002|Z|does NOT have all possible information about this product. This||
1605|003|Z|information does not assure that this product is safe, effective,||
1605|004|Z|or appropriate for you. This information is not individual||
1605|005|Z|medical advice and does not substitute for the advice of your||
1605|006|Z|health care professional. Always ask your health care||
1605|007|Z|professional for complete information about this product and your||
1605|008|Z|specific health needs.||
1605|009|B|||
1605|010|T|POLLEN ALLERGEN EXTRACT - SUBLINGUAL||
1605|011|F|(POL-uh-n)||
1605|012|B|||
1605|013|W|WARNING:  Rarely, this medication can cause a serious (rarely||
1605|014|W|fatal) allergic reaction. Get medical help right away if you||
1605|015|W|notice any symptoms of a serious allergic reaction, including:||
1605|016|W|flushing/rash, itching/swelling (especially of the face, tongue,||
1605|017|W|throat), severe dizziness, fast/weak heartbeat, or trouble||
1605|018|W|breathing. To be sure that you do not have a serious reaction,||
1605|019|W|you will need to stay in a health care setting for 30 minutes||
1605|020|W|after taking this drug for the first time so your doctor can||
1605|021|W|carefully monitor you and provide medical help if needed.||
1605|022|W|   Your doctor will also prescribe another medication||
1605|023|W|(epinephrine) to use if you have a serious allergic reaction||
1605|024|W|outside the health care setting. Read the Patient Information||
1605|025|W|Leaflet for this medication provided by your pharmacist. Learn||
1605|026|W|ahead of time when and how to use your brand of epinephrine, and||
1605|027|W|get medical help right away if you have to use it.||
1605|028|W|   Certain medical conditions may increase the seriousness of an||
1605|029|W|allergic reaction or your risk for an allergic reaction. These||
1605|030|W|include high blood pressure, breathing disorders such as asthma,||
1605|031|W|or heart problems such as angina/irregular heartbeat/previous||
1605|032|W|heart attack. Also, some medications (including beta blockers||
1605|033|W|such as atenolol) may make epinephrine or other rescue||
1605|034|W|medications not work as well or increase your risk for side||
1605|035|W|effects from these medications. Be sure to tell your doctor about||
1605|036|W|all the drugs you use (including prescription/nonprescription||
1605|037|W|drugs and herbal products).||
1605|038|B|||
1605|039|U|USES:  This medication is used to treat certain allergies that||
1605|040|U|may occur seasonally or year round. It is an extract of certain||
1605|041|U|plant pollens that can cause allergies. Before prescribing this||
1605|042|U|medication, your doctor must do lab/medical tests (such as skin||
1605|043|U|or IgE tests) to learn what you are allergic to. This pollen||
1605|044|U|allergen extract works by making your body less sensitive to the||
1605|045|U|pollens (such as ragweed, grasses) that cause your allergies.||
1605|046|U|This medication will not work right away to relieve allergy||
1605|047|U|symptoms. When taken as directed, it may help relieve symptoms||
1605|048|U|such as sneezing, runny/stuffy nose, cough, or itchy/watery eyes||
1605|049|U|that are caused by allergies.||
1605|050|B|||
1605|051|H|HOW TO USE:  Read the Medication Guide provided by your||
1605|052|H|pharmacist before you start taking this medication and each time||
1605|053|H|you get a refill. If you have any questions, ask your doctor or||
1605|054|H|pharmacist.||
1605|055|H|   Take this medication by mouth without food as directed by your||
1605|056|H|doctor, usually once daily. With dry hands, remove one tablet||
1605|057|H|from the package just before taking. Place the tablet under the||
1605|058|H|tongue and allow it to dissolve for at least 1 minute before||
1605|059|H|swallowing. Do not chew or swallow the tablet. Do not eat or||
1605|060|H|drink while the tablet is dissolving in your mouth and for 5||
1605|061|H|minutes after taking it. Wash your hands after handling the||
1605|062|H|tablet.||
1605|063|H|   If needed, an adult should help a child take this medication||
1605|064|H|properly. Watch the child for at least 30 minutes after each dose||
1605|065|H|to make sure the child does not have an allergic reaction to the||
1605|066|H|medication.||
1605|067|H|   For some brands of this medication, your doctor may direct you||
1605|068|H|to start this medication at a low dose and gradually increase||
1605|069|H|your dose to reduce your risk of side effects. Follow your||
1605|070|H|doctor's instructions carefully.||
1605|071|H|   Usually, your doctor will direct you to start taking this||
1605|072|H|medication about 4 months before the expected start of allergy||
1605|073|H|season, and keep taking it throughout the season. Use this||
1605|074|H|medication regularly to get the most benefit from it. To help you||
1605|075|H|remember, take it at the same time each day.||
1605|076|H|   Tell your doctor if your condition does not get better or if||
1605|077|H|it gets worse.||
1605|078|B|||
1605|079|S|SIDE EFFECTS:  Mild mouth/eye/ear/throat itching, throat||
1605|080|S|dryness/irritation, cough, mouth/tongue swelling, or mouth||
1605|081|S|blisters may occur, especially during the first few days of||
1605|082|S|treatment. If any of these effects last or get worse, tell your||
1605|083|S|doctor or pharmacist promptly.||
1605|084|S|   Remember that this medication has been prescribed because your||
1605|085|S|doctor has judged that the benefit to you is greater than the||
1605|086|S|risk of side effects. Many people using this medication do not||
1605|087|S|have serious side effects.||
1605|088|S|   Get medical help right away if you have any very serious side||
1605|089|S|effects, including: throat tightness/swelling, trouble||
1605|090|S|swallowing/breathing, chest pain, voice changes.||
1605|091|S|   A very serious allergic reaction to this drug is rare.||
1605|092|S|However, get medical help right away if you notice any symptoms||
1605|093|S|of a serious allergic reaction (see also Warning Section).||
1605|094|S|   This is not a complete list of possible side effects. If you||
1605|095|S|notice other effects not listed above, contact your doctor or||
1605|096|S|pharmacist.||
1605|097|S|   In the US -||
1605|098|S|   Call your doctor for medical advice about side effects. You||
1605|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1605|100|S|www.fda.gov/medwatch.||
1605|101|S|   In Canada - Call your doctor for medical advice about side||
1605|102|S|effects. You may report side effects to Health Canada at||
1605|103|S|1-866-234-2345.||
1605|104|B|||
1605|105|P|PRECAUTIONS:  See also Warning Section.||
1605|106|P|   Before taking this medication, tell your doctor or pharmacist||
1605|107|P|if you are allergic to it; or to other allergen extracts; or if||
1605|108|P|you have any other allergies. This product may contain inactive||
1605|109|P|ingredients, which can cause allergic reactions or other||
1605|110|P|problems. Talk to your pharmacist for more details.||
1605|111|P|   Before using this medication, tell your doctor or pharmacist||
1605|112|P|your medical history, especially of: breathing disorders (such as||
1605|113|P|asthma, chronic obstructive pulmonary disease-COPD), heart||
1605|114|P|problems (such as angina, irregular heartbeat, previous heart||
1605|115|P|attack), high blood pressure, mouth irritation (such as due to||
1605|116|P|cold sore, ulcer, infection), a certain esophagus problem||
1605|117|P|(eosinophilic esophagitis), previous allergic reaction, other||
1605|118|P|current allergy treatments (such as allergy shots, other allergen||
1605|119|P|extracts).||
1605|120|P|   Before having surgery or a dental procedure, tell your doctor||
1605|121|P|or dentist about all the products you use (including prescription||
1605|122|P|drugs, nonprescription drugs, and herbal products). Your doctor||
1605|123|P|or dentist may direct you to temporarily stop treatment with this||
1605|124|P|medication after dental surgery or a procedure (such as tooth||
1605|125|P|extraction). Ask your doctor or dentist for details.||
1605|126|P|   During pregnancy, this medication should be used only when||
1605|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
1605|128|P|   It is unknown if this medication passes into breast milk.||
1605|129|P|Consult your doctor before breastfeeding.||
1605|130|B|||
1605|131|I|DRUG INTERACTIONS:  See also Warning Section.||
1605|132|I|   Drug interactions may change how your medications work or||
1605|133|I|increase your risk for serious side effects. This document does||
1605|134|I|not contain all possible drug interactions. Keep a list of all||
1605|135|I|the products you use (including prescription/nonprescription||
1605|136|I|drugs and herbal products) and share it with your doctor and||
1605|137|I|pharmacist. Do not start, stop, or change the dosage of any||
1605|138|I|medicines without your doctor's approval.||
1605|139|B|||
1605|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1605|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1605|142|O|poison control center right away. US residents can call||
1605|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1605|144|B|||
1605|145|N|NOTES:  Do not share this medication with others. It may harm||
1605|146|N|them, even if their symptoms are the same as yours.||
1605|147|N|   Your doctor may direct you to also use other medications for||
1605|148|N|allergy symptoms or mild side effects (such as antihistamines,||
1605|149|N|nasal sprays for allergies). Ask your doctor for details.||
1605|150|B|||
1605|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1605|152|D|remember. If it is near the time of the next dose, skip the||
1605|153|D|missed dose. Take your next dose at the regular time. Do not||
1605|154|D|double the dose to catch up.||
1605|155|B|||
1605|156|R|STORAGE:  Store at room temperature away from light and moisture.||
1605|157|R|Do not store in the bathroom. Keep all medications away from||
1605|158|R|children and pets.||
1605|159|R|   Do not flush medications down the toilet or pour them into a||
1605|160|R|drain unless instructed to do so. Properly discard this product||
1605|161|R|when it is expired or no longer needed. Consult your pharmacist||
1605|162|R|or local waste disposal company.||
1605|163|B|||
1605|164|A|Information last revised October 2024.||
1605|165|A|Copyright(c) 2025 First Databank, Inc.||
1605|166|B|||
1606|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1606|002|Z|does NOT have all possible information about this product. This||
1606|003|Z|information does not assure that this product is safe, effective,||
1606|004|Z|or appropriate for you. This information is not individual||
1606|005|Z|medical advice and does not substitute for the advice of your||
1606|006|Z|health care professional. Always ask your health care||
1606|007|Z|professional for complete information about this product and your||
1606|008|Z|specific health needs.||
1606|009|B|||
1606|010|T|UMECLIDINIUM POWDER INHALER - ORAL INHALATION||
1606|011|F|(ue-ME-kli-DIN-ee-um)||
1606|012|B|||
1606|013|C|COMMON BRAND NAME(S): Incruse Ellipta||
1606|014|B|||
1606|015|U|USES:  Umeclidinium is used to control and prevent symptoms (such||
1606|016|U|as wheezing, shortness of breath) caused by ongoing lung disease||
1606|017|U|(chronic obstructive pulmonary disease-COPD, which includes||
1606|018|U|bronchitis and emphysema). It works by relaxing the muscles||
1606|019|U|around the airways so that they open up and you can breathe more||
1606|020|U|easily. Umeclidinium belongs to a class of drugs known as||
1606|021|U|anticholinergics. Controlling symptoms of breathing problems can||
1606|022|U|decrease time lost from work or school.||
1606|023|U|   This medication must be used regularly to be effective. It||
1606|024|U|does not work right away and should not be used to relieve sudden||
1606|025|U|shortness of breath. If wheezing or sudden shortness of breath||
1606|026|U|occurs, use your quick-relief inhaler (such as albuterol, also||
1606|027|U|called salbutamol in some countries) as prescribed.||
1606|028|B|||
1606|029|H|HOW TO USE:  Read the Patient Information Leaflet and||
1606|030|H|Instructions for Use Leaflet for directions on the proper use of||
1606|031|H|this medication. If you have any questions, ask your doctor or||
1606|032|H|pharmacist.||
1606|033|H|   Inhale this medication by mouth as directed by your doctor,||
1606|034|H|usually once daily. Do not open the cover of the inhaler until||
1606|035|H|you are ready to use it. Each time you open the cover, you||
1606|036|H|prepare a dose of the medication. If you open and close the cover||
1606|037|H|without inhaling the medication, you will lose the dose. To avoid||
1606|038|H|wasting a dose, do not close the cover until after you have||
1606|039|H|inhaled the medication. You may or may not taste/feel the drug||
1606|040|H|when you inhale. Do not exhale into the device.||
1606|041|H|   Use this medication regularly to get the most benefit from it.||
1606|042|H|To help you remember, use it at the same time every day. Do not||
1606|043|H|use it more than one time each day.||
1606|044|H|   Do not increase your dose, use this medication more often, or||
1606|045|H|stop using it without first consulting your doctor. Your||
1606|046|H|condition will not improve any faster, and your risk of side||
1606|047|H|effects will increase.||
1606|048|H|   If you are using other inhalers at the same time, wait at||
1606|049|H|least 1 minute between the use of each medication.||
1606|050|H|   Learn which of your inhalers you should use every day and||
1606|051|H|which you should use if your breathing suddenly worsens||
1606|052|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1606|053|H|should do if you have new or worsening cough or shortness of||
1606|054|H|breath, wheezing, increased sputum, waking up at night with||
1606|055|H|trouble breathing, if you use your quick-relief inhaler more||
1606|056|H|often, or if your quick-relief inhaler does not seem to be||
1606|057|H|working well. Learn when you can treat sudden breathing problems||
1606|058|H|by yourself and when you must get medical help right away.||
1606|059|H|   Tell your doctor if your condition does not get better or if||
1606|060|H|it gets worse.||
1606|061|B|||
1606|062|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1606|063|S|because your doctor has judged that the benefit to you is greater||
1606|064|S|than the risk of side effects. Many people using this medication||
1606|065|S|do not have serious side effects.||
1606|066|S|   Tell your doctor right away if you have any serious side||
1606|067|S|effects, including: difficult/painful urination.||
1606|068|S|   Rarely, this medication may cause sudden severe||
1606|069|S|wheezing/trouble breathing right after use. If this occurs, use||
1606|070|S|your quick-relief inhaler and get medical help right away.||
1606|071|S|   Get medical help right away if you have any very serious side||
1606|072|S|effects, including: eye pain/swelling/redness, vision changes||
1606|073|S|(such as seeing rainbows around lights at night, blurred vision).||
1606|074|S|   A very serious allergic reaction to this drug is rare.||
1606|075|S|However, get medical help right away if you notice any symptoms||
1606|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1606|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1606|078|S|breathing.||
1606|079|S|   This is not a complete list of possible side effects. If you||
1606|080|S|notice other effects not listed above, contact your doctor or||
1606|081|S|pharmacist.||
1606|082|S|   In the US -||
1606|083|S|   Call your doctor for medical advice about side effects. You||
1606|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1606|085|S|www.fda.gov/medwatch.||
1606|086|S|   In Canada - Call your doctor for medical advice about side||
1606|087|S|effects. You may report side effects to Health Canada at||
1606|088|S|1-866-234-2345.||
1606|089|B|||
1606|090|P|PRECAUTIONS:  Before using umeclidinium, tell your doctor or||
1606|091|P|pharmacist if you are allergic to it; or if you have any other||
1606|092|P|allergies. This product may contain inactive ingredients (such as||
1606|093|P|milk proteins), which can cause allergic reactions or other||
1606|094|P|problems. Talk to your pharmacist for more details.||
1606|095|P|   Before using this medication, tell your doctor or pharmacist||
1606|096|P|your medical history, especially of: personal or family history||
1606|097|P|of glaucoma (angle-closure type), difficulty urinating (such as||
1606|098|P|due to an enlarged prostate).||
1606|099|P|   Before having surgery, tell your doctor or dentist about all||
1606|100|P|the products you use (including prescription drugs,||
1606|101|P|nonprescription drugs, and herbal products).||
1606|102|P|   During pregnancy, this medication should be used only when||
1606|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
1606|104|P|   It is unknown if this medication passes into breast milk.||
1606|105|P|Consult your doctor before breastfeeding.||
1606|106|B|||
1606|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1606|108|I|medications work or increase your risk for serious side effects.||
1606|109|I|This document does not contain all possible drug interactions.||
1606|110|I|Keep a list of all the products you use (including||
1606|111|I|prescription/nonprescription drugs and herbal products) and share||
1606|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
1606|113|I|the dosage of any medicines without your doctor's approval.||
1606|114|B|||
1606|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1606|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1606|117|O|poison control center right away. US residents can call||
1606|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1606|119|B|||
1606|120|N|NOTES:  Do not share this medication with others.||
1606|121|N|   Avoid smoking and other things that can worsen breathing||
1606|122|N|problems. Because the flu virus can also worsen breathing||
1606|123|N|problems, ask your doctor or pharmacist if you should have a flu||
1606|124|N|shot every year.||
1606|125|B|||
1606|126|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1606|127|D|If it is near the time of the next dose, skip the missed dose.||
1606|128|D|Use your next dose at the regular time. Do not double the dose to||
1606|129|D|catch up. Do not use more than one dose each day.||
1606|130|B|||
1606|131|R|STORAGE:  Store at room temperature away from light, heat, and||
1606|132|R|moisture. Do not store in the bathroom. Do not open the sealed||
1606|133|R|tray until you are ready to use the new inhaler. Once the inhaler||
1606|134|R|is removed from the tray, this medication expires after 6 weeks.||
1606|135|R|Keep all medications away from children and pets.||
1606|136|R|   Do not flush medications down the toilet or pour them into a||
1606|137|R|drain unless instructed to do so. Properly discard this product||
1606|138|R|when it is expired or no longer needed. Consult your pharmacist||
1606|139|R|or local waste disposal company.||
1606|140|B|||
1606|141|M|MEDICAL ALERT:  Your condition can cause complications in a||
1606|142|M|medical emergency. For information about enrolling in MedicAlert,||
1606|143|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1606|144|B|||
1606|145|A|Information last revised October 2024.||
1606|146|A|Copyright(c) 2025 First Databank, Inc.||
1606|147|B|||
1607|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1607|002|Z|does NOT have all possible information about this product. This||
1607|003|Z|information does not assure that this product is safe, effective,||
1607|004|Z|or appropriate for you. This information is not individual||
1607|005|Z|medical advice and does not substitute for the advice of your||
1607|006|Z|health care professional. Always ask your health care||
1607|007|Z|professional for complete information about this product and your||
1607|008|Z|specific health needs.||
1607|009|B|||
1607|010|T|RAMUCIRUMAB - INJECTION||
1607|011|F|(RA-mue-SIR-ue-mab)||
1607|012|B|||
1607|013|C|COMMON BRAND NAME(S): Cyramza||
1607|014|B|||
1607|015|U|USES:  Ramucirumab is used to treat various types of cancers. It||
1607|016|U|works by slowing or stopping the growth of cancer cells.||
1607|017|B|||
1607|018|H|HOW TO USE:  This medication is given by slow injection (usually||
1607|019|H|over 30 minutes or 60 minutes) into a vein by a health care||
1607|020|H|professional. It is given as directed by your doctor, usually||
1607|021|H|every 2 weeks or every 3 weeks.||
1607|022|H|   Infusion reactions may happen during the infusion of this||
1607|023|H|drug. Your doctor may prescribe other medications (such as||
1607|024|H|antihistamines, acetaminophen) before each treatment to help||
1607|025|H|prevent these side effects. Tell your doctor right away if you||
1607|026|H|have any symptoms of infusion reactions such as shaking, back||
1607|027|H|pain/spasms, chest tightness, chills, flushing, rapid heartbeat,||
1607|028|H|dizziness, or skin tingling/burning.||
1607|029|H|   The dosage is based on your medical condition, weight, and||
1607|030|H|response to treatment.||
1607|031|H|   Use this medication regularly to get the most benefit from it.||
1607|032|H|To help you remember, mark your calendar with a reminder.||
1607|033|B|||
1607|034|S|SIDE EFFECTS:  See also How to Use section.||
1607|035|S|   Diarrhea, headache, nausea, vomiting, mouth sores, or weakness||
1607|036|S|may occur. If any of these effects last or get worse, tell your||
1607|037|S|doctor or pharmacist promptly.||
1607|038|S|   Remember that this medication has been prescribed because your||
1607|039|S|doctor has judged that the benefit to you is greater than the||
1607|040|S|risk of side effects. Many people using this medication do not||
1607|041|S|have serious side effects.||
1607|042|S|   Tell your doctor right away if you have any serious side||
1607|043|S|effects, including: signs of kidney problems (such as change in||
1607|044|S|the amount of urine, swelling hands/ankles/feet),||
1607|045|S|redness/blisters/swelling/pain on the palms of your hands or||
1607|046|S|soles of your feet, slow wound healing.||
1607|047|S|   Get medical help right away if you have any very serious side||
1607|048|S|effects, including: chest/jaw/left arm pain, shortness of breath,||
1607|049|S|unusual sweating, weakness on one side of the body, trouble||
1607|050|S|speaking, confusion, sudden vision changes, seizure,||
1607|051|S|sudden/severe back pain or headache.||
1607|052|S|   This medication may raise your blood pressure. Check your||
1607|053|S|blood pressure regularly and tell your doctor if the results are||
1607|054|S|high. Your doctor may control your blood pressure with||
1607|055|S|medication.||
1607|056|S|   This medication may cause serious (possibly fatal) bleeding.||
1607|057|S|It may also rarely cause a hole to open in the stomach or||
1607|058|S|intestines (gastrointestinal perforation). Tell your doctor right||
1607|059|S|away if you have symptoms such as stomach/abdominal pain that||
1607|060|S|doesn't go away, easy bleeding/bruising, bloody or black/tarry||
1607|061|S|stools, vomit that looks like coffee grounds, coughing up blood,||
1607|062|S|lightheadedness, unusual tiredness/weakness.||
1607|063|S|   This medication may lower your ability to fight infections.||
1607|064|S|This may make you more likely to get a serious (rarely fatal)||
1607|065|S|infection or make any infection you have worse. Tell your doctor||
1607|066|S|right away if you have any signs of infection (such as sore||
1607|067|S|throat that doesn't go away, fever, chills).||
1607|068|S|   A very serious allergic reaction to this drug is rare.||
1607|069|S|However, get medical help right away if you notice any symptoms||
1607|070|S|of a serious allergic reaction, including: rash, itching/swelling||
1607|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1607|072|S|breathing.||
1607|073|S|   This is not a complete list of possible side effects. If you||
1607|074|S|notice other effects not listed above, contact your doctor or||
1607|075|S|pharmacist.||
1607|076|S|   In the US -||
1607|077|S|   Call your doctor for medical advice about side effects. You||
1607|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1607|079|S|www.fda.gov/medwatch.||
1607|080|S|   In Canada - Call your doctor for medical advice about side||
1607|081|S|effects. You may report side effects to Health Canada at||
1607|082|S|1-866-234-2345.||
1607|083|B|||
1607|084|P|PRECAUTIONS:  Before receiving ramucirumab, tell your doctor or||
1607|085|P|pharmacist if you are allergic to it; or if you have any other||
1607|086|P|allergies. This product may contain inactive ingredients, which||
1607|087|P|can cause allergic reactions or other problems. Talk to your||
1607|088|P|pharmacist for more details.||
1607|089|P|   Before using this medication, tell your doctor or pharmacist||
1607|090|P|your medical history, especially of: high blood pressure, kidney||
1607|091|P|disease, liver disease, recent surgery, recent injuries/wounds,||
1607|092|P|bleeding/blood problems (such as bleeding of the||
1607|093|P|stomach/intestines), blood vessel problems (such as an aneurysm||
1607|094|P|or a tear/break in the aorta or other blood vessels).||
1607|095|P|   Ramucirumab can make you more likely to get infections or may||
1607|096|P|make current infections worse. Stay away from anyone who has an||
1607|097|P|infection that may easily spread (such as chickenpox, COVID-19,||
1607|098|P|measles, flu). Talk to your doctor if you have been exposed to an||
1607|099|P|infection or for more details.||
1607|100|P|   Tell your health care professional that you are using||
1607|101|P|ramucirumab before having any immunizations/vaccinations. Avoid||
1607|102|P|contact with people who have recently received live vaccines||
1607|103|P|(such as flu vaccine inhaled through the nose).||
1607|104|P|   To lower the chance of getting cut, bruised, or injured, use||
1607|105|P|caution with sharp objects like razors and nail cutters, and||
1607|106|P|avoid activities such as contact sports.||
1607|107|P|   Before having surgery or any medical procedure, tell your||
1607|108|P|doctor or dentist about all the products you use (including||
1607|109|P|prescription drugs, nonprescription drugs, and herbal products).||
1607|110|P|   This medication may cause wounds to heal slowly or poorly.||
1607|111|P|Before having surgery, talk with your doctor about the risks and||
1607|112|P|benefits of this medication. Your doctor may tell you to||
1607|113|P|temporarily stop treatment with this medication at least 28 days||
1607|114|P|before surgery. Ask your doctor for specific instructions about||
1607|115|P|when to stop and when to restart treatment with ramucirumab. Tell||
1607|116|P|your doctor right away if you have wounds that are not healing||
1607|117|P|well.||
1607|118|P|   This medication may decrease fertility in women of||
1607|119|P|childbearing age. Ask your doctor for details.||
1607|120|P|   Tell your doctor if you are pregnant or plan to become||
1607|121|P|pregnant. You should not become pregnant while using ramucirumab.||
1607|122|P|Ramucirumab may harm an unborn baby. Your doctor should order a||
1607|123|P|pregnancy test before you start this medication. Ask about||
1607|124|P|reliable forms of birth control while using this medication and||
1607|125|P|for 3 months after the last dose. If you become pregnant, talk to||
1607|126|P|your doctor right away about the risks and benefits of this||
1607|127|P|medication.||
1607|128|P|   It is unknown if this medication passes into breast milk.||
1607|129|P|Because of the possible risk to the infant, breastfeeding is not||
1607|130|P|recommended while using this medication and for 2 months after||
1607|131|P|the last dose. Consult your doctor before breastfeeding.||
1607|132|B|||
1607|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1607|134|I|medications work or increase your risk for serious side effects.||
1607|135|I|This document does not contain all possible drug interactions.||
1607|136|I|Keep a list of all the products you use (including||
1607|137|I|prescription/nonprescription drugs and herbal products) and share||
1607|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
1607|139|I|the dosage of any medicines without your doctor's approval.||
1607|140|B|||
1607|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1607|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1607|143|O|poison control center right away. US residents can call||
1607|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1607|145|B|||
1607|146|N|NOTES:  Lab and/or medical tests (such as blood pressure, urine||
1607|147|N|protein, complete blood count, liver/thyroid function) should be||
1607|148|N|done while you are using this medication. Keep all medical and||
1607|149|N|lab appointments. Consult your doctor for more details.||
1607|150|B|||
1607|151|D|MISSED DOSE:  It is important to get each dose of this medication||
1607|152|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1607|153|D|right away for a new dosing schedule.||
1607|154|B|||
1607|155|R|STORAGE:  Not applicable. This medication is given in a hospital||
1607|156|R|or clinic and will not be stored at home.||
1607|157|B|||
1607|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
1607|159|M|medical emergency. For information about enrolling in MedicAlert,||
1607|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1607|161|B|||
1607|162|A|Information last revised April 2025.||
1607|163|A|Copyright(c) 2025 First Databank, Inc.||
1607|164|B|||
1608|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1608|002|Z|does NOT have all possible information about this product. This||
1608|003|Z|information does not assure that this product is safe, effective,||
1608|004|Z|or appropriate for you. This information is not individual||
1608|005|Z|medical advice and does not substitute for the advice of your||
1608|006|Z|health care professional. Always ask your health care||
1608|007|Z|professional for complete information about this product and your||
1608|008|Z|specific health needs.||
1608|009|B|||
1608|010|T|CERITINIB - ORAL||
1608|011|F|(se-RI-ti-nib)||
1608|012|B|||
1608|013|C|COMMON BRAND NAME(S): Zykadia||
1608|014|B|||
1608|015|U|USES:  Ceritinib is used to treat lung cancer. It is used for||
1608|016|U|lung cancers that have a certain type of abnormal "ALK" gene.||
1608|017|U|Ceritinib belongs to a class of drugs known as kinase inhibitors.||
1608|018|U|It works by slowing or stopping the growth of cancer cells.||
1608|019|B|||
1608|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1608|021|H|from your pharmacist before you start taking ceritinib and each||
1608|022|H|time you get a refill. If you have any questions, ask your doctor||
1608|023|H|or pharmacist.||
1608|024|H|   Take this medication by mouth with food as directed by your||
1608|025|H|doctor, usually once daily.||
1608|026|H|   The dosage is based on your medical condition, lab tests,||
1608|027|H|response to treatment, and other medications you may be taking.||
1608|028|H|Be sure to tell your doctor and pharmacist about all the products||
1608|029|H|you use (including prescription drugs, nonprescription drugs, and||
1608|030|H|herbal products).||
1608|031|H|   Medications that reduce stomach acid (such as antacids, proton||
1608|032|H|pump inhibitors/PPIs, H2 blockers) may make ceritinib work less||
1608|033|H|well. Ask your doctor or pharmacist for more details.||
1608|034|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1608|035|H|using this medication unless your doctor or pharmacist says you||
1608|036|H|may do so safely. Grapefruit can increase the chance of side||
1608|037|H|effects with this medicine. Ask your doctor or pharmacist for||
1608|038|H|more details.||
1608|039|H|   Use this medication regularly to get the most benefit from it.||
1608|040|H|To help you remember, use it at the same time each day.||
1608|041|H|   Do not increase your dose or use this drug more often or for||
1608|042|H|longer than prescribed. Your condition will not improve any||
1608|043|H|faster, and your risk of serious side effects will increase.||
1608|044|H|   If you vomit after taking a dose, do not take another dose at||
1608|045|H|that time. Take your next dose at the regular time.||
1608|046|H|   Since this drug can be absorbed through the skin and lungs and||
1608|047|H|may harm an unborn baby, women who are pregnant or who may become||
1608|048|H|pregnant should not handle this medication or breathe the dust||
1608|049|H|from the capsules.||
1608|050|B|||
1608|051|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, abdominal pain, loss||
1608|052|S|of appetite, heartburn, constipation, or tiredness may occur.||
1608|053|S|Nausea and vomiting can be severe. In some cases, your doctor may||
1608|054|S|prescribe medication to prevent or relieve nausea, vomiting, or||
1608|055|S|diarrhea. Eating several small meals, not eating before||
1608|056|S|treatment, or limiting activity may help lessen some of these||
1608|057|S|effects. If any of these effects last or get worse, tell your||
1608|058|S|doctor or pharmacist promptly.||
1608|059|S|   People using this medication may have serious side effects.||
1608|060|S|However, you have been prescribed this drug because your doctor||
1608|061|S|has judged that the benefit to you is greater than the risk of||
1608|062|S|side effects. Careful monitoring by your doctor may decrease your||
1608|063|S|risk.||
1608|064|S|   Tell your doctor right away if you have any serious side||
1608|065|S|effects, including: numbness/tingling, symptoms of liver problems||
1608|066|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
1608|067|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), vision||
1608|068|S|changes (such as blurred vision, decreased vision), weakness.||
1608|069|S|   Get medical help right away if you have any very serious side||
1608|070|S|effects, including: trouble breathing, cough with or without||
1608|071|S|phlegm, fast/slow/irregular heartbeat, severe dizziness,||
1608|072|S|fainting, seizure.||
1608|073|S|   This medication may rarely make your blood sugar rise, which||
1608|074|S|can cause or worsen diabetes. Tell your doctor right away if you||
1608|075|S|have symptoms of high blood sugar such as increased||
1608|076|S|thirst/urination. If you already have diabetes, check your blood||
1608|077|S|sugar regularly as directed and share the results with your||
1608|078|S|doctor. Your doctor may need to adjust your diabetes medication,||
1608|079|S|exercise program, or diet.||
1608|080|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
1608|081|S|Contact your doctor promptly if you notice any symptoms of||
1608|082|S|dehydration, such as unusual decreased urination, unusual dry||
1608|083|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness.||
1608|084|S|   A very serious allergic reaction to this drug is rare.||
1608|085|S|However, get medical help right away if you notice any symptoms||
1608|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1608|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1608|088|S|breathing.||
1608|089|S|   Ceritinib can commonly cause a rash that is usually not||
1608|090|S|serious. However, you may not be able to tell it apart from a||
1608|091|S|rare rash that could be a sign of a severe reaction. Tell your||
1608|092|S|doctor right away if you develop any rash.||
1608|093|S|   This is not a complete list of possible side effects. If you||
1608|094|S|notice other effects not listed above, contact your doctor or||
1608|095|S|pharmacist.||
1608|096|S|   In the US -||
1608|097|S|   Call your doctor for medical advice about side effects. You||
1608|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1608|099|S|www.fda.gov/medwatch.||
1608|100|S|   In Canada - Call your doctor for medical advice about side||
1608|101|S|effects. You may report side effects to Health Canada at||
1608|102|S|1-866-234-2345.||
1608|103|B|||
1608|104|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1608|105|P|pharmacist if you are allergic to it; or if you have any other||
1608|106|P|allergies. This product may contain inactive ingredients, which||
1608|107|P|can cause allergic reactions or other problems. Talk to your||
1608|108|P|pharmacist for more details.||
1608|109|P|   Before using this medication, tell your doctor or pharmacist||
1608|110|P|your medical history, especially of: diabetes or high blood||
1608|111|P|sugar, liver problems.||
1608|112|P|   Ceritinib may cause a condition that affects the heart rhythm||
1608|113|P|(QT prolongation). QT prolongation can rarely cause serious||
1608|114|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1608|115|P|as severe dizziness, fainting) that need medical attention right||
1608|116|P|away.||
1608|117|P|   The risk of QT prolongation may be increased if you have||
1608|118|P|certain medical conditions or are taking other drugs that may||
1608|119|P|cause QT prolongation. Before using ceritinib, tell your doctor||
1608|120|P|or pharmacist of all the drugs you take and if you have any of||
1608|121|P|the following conditions: certain heart problems (heart failure,||
1608|122|P|slow heartbeat, QT prolongation in the EKG), family history of||
1608|123|P|certain heart problems (QT prolongation in the EKG, sudden||
1608|124|P|cardiac death).||
1608|125|P|   Low levels of potassium or magnesium in the blood may also||
1608|126|P|increase your risk of QT prolongation. This risk may increase if||
1608|127|P|you use certain drugs (such as diuretics/"water pills") or if you||
1608|128|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1608|129|P|Talk to your doctor about using ceritinib safely.||
1608|130|P|   This drug may rarely cause vision changes. Do not drive, use||
1608|131|P|machinery, or do anything that needs alertness or clear vision||
1608|132|P|until you can do it safely. Limit alcoholic beverages.||
1608|133|P|   This medication may make you more sensitive to the sun. Limit||
1608|134|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1608|135|P|sunscreen and wear protective clothing when outdoors. Tell your||
1608|136|P|doctor right away if you get sunburned or have skin||
1608|137|P|blisters/redness.||
1608|138|P|   Before having surgery, tell your doctor or dentist about all||
1608|139|P|the products you use (including prescription drugs,||
1608|140|P|nonprescription drugs, and herbal products).||
1608|141|P|   Older adults may be more sensitive to the side effects of this||
1608|142|P|drug, especially QT prolongation (see above).||
1608|143|P|   Since this drug can be absorbed through the skin and lungs and||
1608|144|P|may harm an unborn baby, women who are pregnant or who may become||
1608|145|P|pregnant should not handle this medication or breathe the dust||
1608|146|P|from the capsules.||
1608|147|P|   Tell your doctor if you are pregnant or plan to become||
1608|148|P|pregnant. You should not become pregnant while using ceritinib.||
1608|149|P|Ceritinib may harm an unborn baby. Your doctor should order a||
1608|150|P|pregnancy test before you start this medication. Women using this||
1608|151|P|medication should ask about reliable forms of birth control||
1608|152|P|during treatment and for 6 months after the last dose. Men using||
1608|153|P|this medication should ask about reliable forms of birth control||
1608|154|P|during treatment and for 3 months after the last dose. If you or||
1608|155|P|your partner becomes pregnant, talk to your doctor right away||
1608|156|P|about the risks and benefits of this medication.||
1608|157|P|   It is unknown if this medication passes into breast milk.||
1608|158|P|Because of the possible risk to the infant, breastfeeding is not||
1608|159|P|recommended while using this medication and for 2 weeks after the||
1608|160|P|last dose. Consult your doctor before breastfeeding.||
1608|161|B|||
1608|162|I|DRUG INTERACTIONS:  See also How to Use section.||
1608|163|I|   Drug interactions may change how your medications work or||
1608|164|I|increase your risk for serious side effects. This document does||
1608|165|I|not contain all possible drug interactions. Keep a list of all||
1608|166|I|the products you use (including prescription/nonprescription||
1608|167|I|drugs and herbal products) and share it with your doctor and||
1608|168|I|pharmacist. Do not start, stop, or change the dosage of any||
1608|169|I|medicines without your doctor's approval.||
1608|170|I|   Some products that may interact with this drug include: other||
1608|171|I|drugs that may slow the heartbeat (including digoxin, clonidine,||
1608|172|I|beta-blockers such as atenolol/metoprolol, calcium channel||
1608|173|I|blockers such as diltiazem/verapamil).||
1608|174|I|   Other medications can affect the removal of ceritinib from||
1608|175|I|your body, which may affect how ceritinib works. Examples include||
1608|176|I|azole antifungals (such as itraconazole, ketoconazole),||
1608|177|I|lonafarnib, macrolide antibiotics (such as erythromycin),||
1608|178|I|rifamycins (such as rifampin, rifabutin), drugs for seizures||
1608|179|I|(such as carbamazepine, phenytoin), St. John's wort, among||
1608|180|I|others.||
1608|181|I|   This medication can slow down the removal of other medications||
1608|182|I|from your body, which may affect how they work. Examples include||
1608|183|I|alfentanil, daridorexant, ergots (such as ergotamine), fentanyl,||
1608|184|I|finerenone, flibanserin, ivabradine, lurasidone, mavacamten,||
1608|185|I|tacrolimus, triazolam, among others.||
1608|186|I|   Many drugs besides ceritinib may affect the heart rhythm (QT||
1608|187|I|prolongation), including pacritinib, among others.||
1608|188|B|||
1608|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1608|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1608|191|O|poison control center right away. US residents can call||
1608|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1608|193|B|||
1608|194|N|NOTES:  Do not share this medication with others.||
1608|195|N|   Lab and/or medical tests (such as liver function, blood sugar,||
1608|196|N|EKG, complete blood counts, heart rate, amylase/lipase level)||
1608|197|N|should be done before you start taking this medication and while||
1608|198|N|you are taking it. Keep all medical and lab appointments. Consult||
1608|199|N|your doctor for more details.||
1608|200|B|||
1608|201|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1608|202|D|remember. If it is less than 12 hours before the next dose, skip||
1608|203|D|the missed dose. Take your next dose at the regular time. Do not||
1608|204|D|double the dose to catch up.||
1608|205|B|||
1608|206|R|STORAGE:  Store at room temperature away from light and moisture.||
1608|207|R|Do not store in the bathroom. Keep all medications away from||
1608|208|R|children and pets.||
1608|209|R|   Do not flush medications down the toilet or pour them into a||
1608|210|R|drain unless instructed to do so. Properly discard this product||
1608|211|R|when it is expired or no longer needed. Consult your pharmacist||
1608|212|R|or local waste disposal company.||
1608|213|B|||
1608|214|A|Information last revised June 2025.||
1608|215|A|Copyright(c) 2025 First Databank, Inc.||
1608|216|B|||
1609|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1609|002|Z|does NOT have all possible information about this product. This||
1609|003|Z|information does not assure that this product is safe, effective,||
1609|004|Z|or appropriate for you. This information is not individual||
1609|005|Z|medical advice and does not substitute for the advice of your||
1609|006|Z|health care professional. Always ask your health care||
1609|007|Z|professional for complete information about this product and your||
1609|008|Z|specific health needs.||
1609|009|B|||
1609|010|T|INDACATEROL/GLYCOPYRROLATE POWDER IN CAPSULE - INHALATION||
1609|011|F|(IN-da-KA-ter-ol/GLYE-koe-PIR-oh-late)||
1609|012|B|||
1609|013|C|COMMON BRAND NAME(S): Utibron Neohaler||
1609|014|B|||
1609|015|U|USES:  This product is used to control and prevent symptoms (such||
1609|016|U|as wheezing and shortness of breath) caused by ongoing lung||
1609|017|U|disease (chronic obstructive pulmonary disease-COPD, which||
1609|018|U|includes chronic bronchitis and emphysema). Controlling symptoms||
1609|019|U|of breathing problems helps you stay active. This inhaler||
1609|020|U|contains 2 medications: indacaterol and glycopyrrolate. Both||
1609|021|U|drugs work by relaxing the muscles around the airways so that||
1609|022|U|they open up and you can breathe more easily. Indacaterol belongs||
1609|023|U|to the class of drugs known as long-acting beta agonists (LABAs).||
1609|024|U|Glycopyrrolate belongs to a class of drugs known as||
1609|025|U|anticholinergics. Both drugs are also known as bronchodilators.||
1609|026|U|   This medication must be used regularly to be effective. It||
1609|027|U|does not work right away and should not be used to relieve sudden||
1609|028|U|shortness of breath. If sudden breathing problems occur, use your||
1609|029|U|quick-relief inhaler as prescribed.||
1609|030|U|   Indacaterol/glycopyrrolate is not approved to treat asthma.||
1609|031|U|People with asthma using long-acting inhaled beta agonists (such||
1609|032|U|as indacaterol) without also using an inhaled corticosteroid may||
1609|033|U|have an increased risk of serious (sometimes fatal) breathing||
1609|034|U|problems.||
1609|035|B|||
1609|036|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1609|037|H|your pharmacist before you start using this medication and each||
1609|038|H|time you get a refill. Follow the illustrated directions for the||
1609|039|H|proper use of this medication. If you have any questions, ask||
1609|040|H|your doctor or pharmacist.||
1609|041|H|   Do not swallow these capsules. Use only the special inhaler||
1609|042|H|that comes with the medication to inhale the powder in the||
1609|043|H|capsules. Inhale this medication by mouth as directed by your||
1609|044|H|doctor, usually once or twice daily, depending on the brand that||
1609|045|H|you use.||
1609|046|H|   Leave the capsule sealed in the blister packet until just||
1609|047|H|before use. Dry your hands before touching the capsules. Do not||
1609|048|H|push the capsule through the foil. Follow the instructions for||
1609|049|H|loading the capsule into the inhaler and for piercing it. Inhale||
1609|050|H|rapidly and deeply through the mouthpiece. You should hear the||
1609|051|H|inhaler make a whirring noise as you inhale the medication. You||
1609|052|H|will also have a sweet taste from the medicine. Hold your breath||
1609|053|H|for at least 5 to 10 seconds. Open the inhaler to see if any||
1609|054|H|powder is left in the capsule. If there is, close the inhaler and||
1609|055|H|inhale again. Inhale all of the powder from each capsule. Do not||
1609|056|H|blow into the mouthpiece at any time.||
1609|057|H|   Avoid getting this medication into your eyes. It may cause eye||
1609|058|H|pain/irritation, temporary blurred vision, and other vision||
1609|059|H|changes.||
1609|060|H|   If you are using other inhalers at the same time, wait at||
1609|061|H|least 1 minute between the use of each medication.||
1609|062|H|   Use this medication regularly to get the most benefit from it.||
1609|063|H|To help you remember, use it at the same time(s) each day. Do not||
1609|064|H|increase your dose or use this drug more often than prescribed,||
1609|065|H|or stop using it without first asking your doctor.||
1609|066|H|   Do not wash the inhaler with water. You may wipe the||
1609|067|H|mouthpiece inside and outside with a clean, dry, lint-free cloth.||
1609|068|H|   If you have been using a quick-relief inhaler (such as||
1609|069|H|albuterol, also called salbutamol in some countries) on a regular||
1609|070|H|daily schedule (such as 4 times daily), you must stop this||
1609|071|H|schedule and only use the quick-relief inhaler as needed for||
1609|072|H|sudden shortness of breath. Consult your doctor for details.||
1609|073|H|   Learn which of your inhalers you should use every day and||
1609|074|H|which you should use if your breathing suddenly worsens||
1609|075|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1609|076|H|should do if you have new or worsening cough or shortness of||
1609|077|H|breath, wheezing, increased sputum, waking up at night with||
1609|078|H|trouble breathing, if you use your quick-relief inhaler more||
1609|079|H|often, or if your quick-relief inhaler does not seem to be||
1609|080|H|working well. Learn when you can treat sudden breathing problems||
1609|081|H|by yourself and when you must get medical help right away.||
1609|082|H|   Tell your doctor if your condition does not get better or if||
1609|083|H|it gets worse.||
1609|084|B|||
1609|085|S|SIDE EFFECTS:  Coughing may occur. Headache and dizziness may||
1609|086|S|also occur, but are less common. If any of these effects last or||
1609|087|S|get worse, tell your doctor or pharmacist promptly.||
1609|088|S|   Remember that this medication has been prescribed because your||
1609|089|S|doctor has judged that the benefit to you is greater than the||
1609|090|S|risk of side effects. Many people using this medication do not||
1609|091|S|have serious side effects.||
1609|092|S|   Tell your doctor right away if you have any serious side||
1609|093|S|effects, including: shaking (tremor), fast/irregular heartbeat,||
1609|094|S|difficult/painful urination, muscle cramps/weakness, increased||
1609|095|S|thirst/urination.||
1609|096|S|   This medication may raise your blood pressure. Check your||
1609|097|S|blood pressure regularly and tell your doctor if the results are||
1609|098|S|high.||
1609|099|S|   Rarely, this medication may cause sudden, severe||
1609|100|S|wheezing/trouble breathing immediately after you use it. If this||
1609|101|S|happens, use your quick-relief inhaler and get medical help right||
1609|102|S|away.||
1609|103|S|   Get medical help right away if you have any very serious side||
1609|104|S|effects, including: chest pain, eye pain/swelling/redness, vision||
1609|105|S|changes (such as seeing rainbows around lights at night, blurred||
1609|106|S|vision).||
1609|107|S|   A very serious allergic reaction to this drug is rare.||
1609|108|S|However, get medical help right away if you notice any symptoms||
1609|109|S|of a serious allergic reaction, including: rash, itching/swelling||
1609|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1609|111|S|breathing.||
1609|112|S|   This is not a complete list of possible side effects. If you||
1609|113|S|notice other effects not listed above, contact your doctor or||
1609|114|S|pharmacist.||
1609|115|S|   In the US -||
1609|116|S|   Call your doctor for medical advice about side effects. You||
1609|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1609|118|S|www.fda.gov/medwatch.||
1609|119|S|   In Canada - Call your doctor for medical advice about side||
1609|120|S|effects. You may report side effects to Health Canada at||
1609|121|S|1-866-234-2345.||
1609|122|B|||
1609|123|P|PRECAUTIONS:  Before using indacaterol/glycopyrrolate, tell your||
1609|124|P|doctor or pharmacist if you are allergic to either drug, or if||
1609|125|P|you have any other allergies. This product may contain inactive||
1609|126|P|ingredients (such as milk proteins), which can cause allergic||
1609|127|P|reactions or other problems. Talk to your pharmacist for more||
1609|128|P|details.||
1609|129|P|   Before using this medication, tell your doctor or pharmacist||
1609|130|P|your medical history, especially of: heart problems (such as||
1609|131|P|chest pain, irregular heartbeat), high blood pressure, seizures,||
1609|132|P|overactive thyroid, diabetes, personal or family history of||
1609|133|P|glaucoma (angle-closure type), difficulty urinating (such as due||
1609|134|P|to an enlarged prostate, urinary tract blockage), kidney disease.||
1609|135|P|   This drug may uncommonly cause dizziness or blurred vision. Do||
1609|136|P|not drive, use machinery, or do anything that needs alertness or||
1609|137|P|clear vision until you can do it safely.||
1609|138|P|   Before having surgery, tell your doctor or dentist about all||
1609|139|P|the products you use (including prescription drugs,||
1609|140|P|nonprescription drugs, and herbal products).||
1609|141|P|   During pregnancy, this medication should be used only when||
1609|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
1609|143|P|   It is unknown if this medication passes into breast milk.||
1609|144|P|Consult your doctor before breastfeeding.||
1609|145|B|||
1609|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1609|147|I|medications work or increase your risk for serious side effects.||
1609|148|I|This document does not contain all possible drug interactions.||
1609|149|I|Keep a list of all the products you use (including||
1609|150|I|prescription/nonprescription drugs and herbal products) and share||
1609|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
1609|152|I|the dosage of any medicines without your doctor's approval.||
1609|153|I|   Do not use other LABA drugs (such as formoterol, salmeterol)||
1609|154|I|while using this medication.||
1609|155|B|||
1609|156|O|OVERDOSE:  This medication will not work and may be harmful if||
1609|157|O|swallowed. If someone has overdosed and has serious symptoms such||
1609|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1609|159|O|poison control center right away. US residents can call||
1609|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1609|161|O|Symptoms of overdose may include: shaking (tremor), chest pain,||
1609|162|O|fast/irregular heartbeat.||
1609|163|B|||
1609|164|N|NOTES:  Do not share this medication with others.||
1609|165|N|   Lab and/or medical tests (such as lung function, blood||
1609|166|N|pressure, pulse/heart rate) should be done while you are using||
1609|167|N|this medication. Keep all medical and lab appointments. Consult||
1609|168|N|your doctor for more details.||
1609|169|N|   Avoid smoking and other things that can worsen breathing||
1609|170|N|problems. Because the flu virus can also worsen breathing||
1609|171|N|problems, ask your doctor or pharmacist if you should have a flu||
1609|172|N|shot every year.||
1609|173|B|||
1609|174|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1609|175|D|If it is near the time of the next dose, skip the missed dose.||
1609|176|D|Use your next dose at the regular time. Do not double the dose to||
1609|177|D|catch up.||
1609|178|B|||
1609|179|R|STORAGE:  Store at room temperature away from heat, light, and||
1609|180|R|moisture. Do not store in the bathroom. Discard the inhaler after||
1609|181|R|30 days of use. Keep all medications away from children and pets.||
1609|182|R|   Do not flush medications down the toilet or pour them into a||
1609|183|R|drain unless instructed to do so. Properly discard this product||
1609|184|R|when it is expired or no longer needed. Consult your pharmacist||
1609|185|R|or local waste disposal company.||
1609|186|B|||
1609|187|M|MEDICAL ALERT:  Your condition can cause complications in a||
1609|188|M|medical emergency. For information about enrolling in MedicAlert,||
1609|189|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1609|190|B|||
1609|191|A|Information last revised July 2025.||
1609|192|A|Copyright(c) 2025 First Databank, Inc.||
1609|193|B|||
1610|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1610|002|Z|does NOT have all possible information about this product. This||
1610|003|Z|information does not assure that this product is safe, effective,||
1610|004|Z|or appropriate for you. This information is not individual||
1610|005|Z|medical advice and does not substitute for the advice of your||
1610|006|Z|health care professional. Always ask your health care||
1610|007|Z|professional for complete information about this product and your||
1610|008|Z|specific health needs.||
1610|009|B|||
1610|010|T|VORAPAXAR - ORAL||
1610|011|F|(VOR-a-PAX-ar)||
1610|012|B|||
1610|013|C|COMMON BRAND NAME(S): Zontivity||
1610|014|B|||
1610|015|W|WARNING:  Vorapaxar increases the risk of bleeding, which may||
1610|016|W|include bleeding in the brain and other serious (possibly fatal)||
1610|017|W|bleeding problems.||
1610|018|W|   Do not use vorapaxar if you have had a stroke, mini-stroke||
1610|019|W|(transient ischemic attack - TIA), or bleeding in the brain in||
1610|020|W|the past; or if you have any current bleeding problems. Discuss||
1610|021|W|the benefits and risks of this medication with your doctor.||
1610|022|B|||
1610|023|U|USES:  Vorapaxar is used to help prevent heart attacks and||
1610|024|U|strokes in people who have had a heart attack or have poor blood||
1610|025|U|flow (peripheral arterial disease).||
1610|026|U|   It works by blocking certain blood cells called platelets from||
1610|027|U|sticking together and forming harmful blood clots. Harmful blood||
1610|028|U|clots can cause heart attacks, strokes, and other serious||
1610|029|U|problems. This "anti-platelet" effect helps keep blood flowing||
1610|030|U|smoothly in your body.||
1610|031|B|||
1610|032|H|HOW TO USE:  Read the Medication Guide provided by your||
1610|033|H|pharmacist before you start taking vorapaxar and each time you||
1610|034|H|get a refill. If you have any questions, ask your doctor or||
1610|035|H|pharmacist.||
1610|036|H|   Take this medication by mouth with or without food as directed||
1610|037|H|by your doctor, usually once daily. Take it regularly to get the||
1610|038|H|most benefit from it. To help you remember, take it at the same||
1610|039|H|time each day.||
1610|040|H|   Your doctor may direct you to take other anti-platelet drugs||
1610|041|H|(such as aspirin, clopidogrel) with this medication. Follow your||
1610|042|H|doctor's directions carefully.||
1610|043|H|   Do not increase your dose or take this medication more often||
1610|044|H|than prescribed. Your condition will not improve any faster, and||
1610|045|H|your risk of side effects will increase.||
1610|046|H|   Keep taking vorapaxar even if you feel well. Do not stop||
1610|047|H|taking it without consulting your doctor.||
1610|048|B|||
1610|049|S|SIDE EFFECTS:  Easy bruising/bleeding, such as nosebleeds, may||
1610|050|S|occur. If this effect lasts or gets worse, tell your doctor or||
1610|051|S|pharmacist promptly.||
1610|052|S|   Remember that this medication has been prescribed because your||
1610|053|S|doctor has judged that the benefit to you is greater than the||
1610|054|S|risk of side effects. Many people using this medication do not||
1610|055|S|have serious side effects.||
1610|056|S|   Get medical help right away if you have any very serious side||
1610|057|S|effects, including any of these signs of bleeding: bleeding that||
1610|058|S|doesn't stop or bleeding too much, stomach/abdominal pain,||
1610|059|S|lasting nausea/vomiting, coughing or vomiting up blood, vomit||
1610|060|S|that looks like coffee grounds, bloody/black/tarry stools,||
1610|061|S|bloody/pink/dark urine, sudden severe headache, confusion,||
1610|062|S|dizziness, fainting, seizures, unusual weakness, weakness on one||
1610|063|S|side of the body, trouble speaking, unusual drowsiness, loss of||
1610|064|S|consciousness.||
1610|065|S|   A very serious allergic reaction to this drug is rare.||
1610|066|S|However, get medical help right away if you notice any symptoms||
1610|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1610|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1610|069|S|breathing.||
1610|070|S|   This is not a complete list of possible side effects. If you||
1610|071|S|notice other effects not listed above, contact your doctor or||
1610|072|S|pharmacist.||
1610|073|S|   In the US -||
1610|074|S|   Call your doctor for medical advice about side effects. You||
1610|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1610|076|S|www.fda.gov/medwatch.||
1610|077|S|   In Canada - Call your doctor for medical advice about side||
1610|078|S|effects. You may report side effects to Health Canada at||
1610|079|S|1-866-234-2345.||
1610|080|B|||
1610|081|P|PRECAUTIONS:  Before taking vorapaxar, tell your doctor or||
1610|082|P|pharmacist if you are allergic to it or if you have any other||
1610|083|P|allergies. This product may contain inactive ingredients, which||
1610|084|P|can cause allergic reactions or other problems. Talk to your||
1610|085|P|pharmacist for more details.||
1610|086|P|   Before using this medication, tell your doctor or pharmacist||
1610|087|P|your medical history, especially of: stroke (including||
1610|088|P|mini-strokes, TIAs), current and past bleeding problems (such as||
1610|089|P|bleeding in the brain, stomach ulcers, hemophilia), recent||
1610|090|P|surgery, serious injury, liver disease.||
1610|091|P|   While you are taking this medication, it may take longer than||
1610|092|P|usual for bleeding to stop if you have a cut or injury. To lower||
1610|093|P|the chance of getting cut, bruised, or injured, use caution with||
1610|094|P|sharp objects like razors and nail cutters, and avoid activities||
1610|095|P|such as contact sports.||
1610|096|P|   Since vorapaxar stays in your body for a long time, you will||
1610|097|P|still be at risk for bleeding for about 4 weeks after this||
1610|098|P|medication is stopped.||
1610|099|P|   Limit alcoholic beverages. Daily use of alcohol, especially||
1610|100|P|when combined with this medicine, may increase your risk for||
1610|101|P|stomach bleeding.||
1610|102|P|   Before having surgery, tell your doctor or dentist that you||
1610|103|P|are taking this medication and about all the products you use||
1610|104|P|(including prescription drugs, nonprescription drugs, and herbal||
1610|105|P|products).||
1610|106|P|   During pregnancy, this medication should be used only when||
1610|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
1610|108|P|   It is unknown if this medication passes into breast milk.||
1610|109|P|Consult your doctor before breastfeeding.||
1610|110|B|||
1610|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1610|112|I|medications work or increase your risk for serious side effects.||
1610|113|I|This document does not contain all possible drug interactions.||
1610|114|I|Keep a list of all the products you use (including||
1610|115|I|prescription/nonprescription drugs and herbal products) and share||
1610|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1610|117|I|the dosage of any medicines without your doctor's approval.||
1610|118|I|   Some products that may interact with this drug include:||
1610|119|I|tipranavir, antidepressants (such as amitriptyline, clomipramine,||
1610|120|I|SSRIs including paroxetine/citalopram, SNRIs including||
1610|121|I|duloxetine/desvenlafaxine/venlafaxine), other drugs that can||
1610|122|I|cause bleeding/bruising (including anticoagulants such as||
1610|123|I|dabigatran, warfarin).||
1610|124|I|   Other medications can affect the removal of vorapaxar from||
1610|125|I|your body, which may affect how vorapaxar works. Examples include||
1610|126|I|azole antifungals (such as itraconazole, ketoconazole),||
1610|127|I|cobicistat, HIV protease inhibitors (such as nelfinavir),||
1610|128|I|macrolide antibiotics (such as clarithromycin), rifamycins (such||
1610|129|I|as rifampin), ritonavir, St. John's wort, drugs used to treat||
1610|130|I|seizures (such as carbamazepine, phenytoin), among others.||
1610|131|I|   Check all prescription and nonprescription medicine labels||
1610|132|I|carefully since many contain pain relievers/fever reducers||
1610|133|I|(aspirin, NSAIDs such as ibuprofen or naproxen). These drugs also||
1610|134|I|have anti-platelet effects and may increase your risk of side||
1610|135|I|effects if taken together. However, if your doctor has told you||
1610|136|I|to take low-dose aspirin to prevent heart attack or stroke||
1610|137|I|(usually 81-162 milligrams a day), you should keep taking the||
1610|138|I|aspirin unless your doctor tells you not to. Ask your doctor or||
1610|139|I|pharmacist for more details.||
1610|140|B|||
1610|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1610|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1610|143|O|poison control center right away. US residents can call||
1610|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1610|145|B|||
1610|146|N|NOTES:  Do not share this medication with others.||
1610|147|N|   Lab and/or medical tests (such as complete blood count) should||
1610|148|N|be done while you are taking this medication. Keep all medical||
1610|149|N|and lab appointments. Consult your doctor for more details.||
1610|150|B|||
1610|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1610|152|D|remember. If it is near the time of the next dose, skip the||
1610|153|D|missed dose. Take your next dose at the regular time. Do not||
1610|154|D|double the dose to catch up.||
1610|155|B|||
1610|156|R|STORAGE:  Store in the original bottle or blister packs at room||
1610|157|R|temperature away from moisture. Do not store in the bathroom.||
1610|158|R|Keep the drying agent (desiccant) in the bottle. Tightly close||
1610|159|R|the bottle when not in use. Keep all medications away from||
1610|160|R|children and pets.||
1610|161|R|   Do not flush medications down the toilet or pour them into a||
1610|162|R|drain unless instructed to do so. Properly discard this product||
1610|163|R|when it is expired or no longer needed. Consult your pharmacist||
1610|164|R|or local waste disposal company.||
1610|165|B|||
1610|166|M|MEDICAL ALERT:  Your condition can cause complications in a||
1610|167|M|medical emergency. For information about enrolling in MedicAlert,||
1610|168|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1610|169|B|||
1610|170|A|Information last revised July 2024.||
1610|171|A|Copyright(c) 2025 First Databank, Inc.||
1610|172|B|||
1611|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1611|002|Z|does NOT have all possible information about this product. This||
1611|003|Z|information does not assure that this product is safe, effective,||
1611|004|Z|or appropriate for you. This information is not individual||
1611|005|Z|medical advice and does not substitute for the advice of your||
1611|006|Z|health care professional. Always ask your health care||
1611|007|Z|professional for complete information about this product and your||
1611|008|Z|specific health needs.||
1611|009|B|||
1611|010|T|ACYCLOVIR TABLET - BUCCAL||
1611|011|F|(ay-SYE-kloe-vir)||
1611|012|B|||
1611|013|C|COMMON BRAND NAME(S): Sitavig||
1611|014|B|||
1611|015|U|USES:  This medication is used to treat cold sores around the||
1611|016|U|mouth (caused by herpes virus) that keep coming back.||
1611|017|U|   Acyclovir is an antiviral drug. However, it is not a cure for||
1611|018|U|the infection. The virus that causes infection continues to live||
1611|019|U|in the body between outbreaks. Acyclovir makes outbreaks shorter||
1611|020|U|and less severe. It helps the sores heal faster, keeps new sores||
1611|021|U|from forming, and decreases pain/itching. This medication may||
1611|022|U|also help reduce how long pain lasts after the sores heal.||
1611|023|B|||
1611|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
1611|025|H|Instructions for Use if available from your pharmacist before you||
1611|026|H|start using acyclovir buccal tablets and each time you get a||
1611|027|H|refill. If you have any questions, ask your doctor or pharmacist.||
1611|028|H|   Apply one tablet within one hour after you have the first||
1611|029|H|symptom of a cold sore, and before a cold sore appears. Symptoms||
1611|030|H|may include itching, redness, burning, or tingling. Apply the||
1611|031|H|tablet on the same side of your mouth as the cold sore symptoms.||
1611|032|H|   Before applying the tablet, find the area in your mouth in||
1611|033|H|which to place the tablet. It should be placed on the upper gum,||
1611|034|H|just above the left or right incisor tooth. The incisors are the||
1611|035|H|teeth just to the left and right of your two front teeth. With||
1611|036|H|dry hands, remove one tablet from the blister pack and place it||
1611|037|H|in your mouth with the round side facing against your gum and||
1611|038|H|gently push it into place. Remove your hand from inside your||
1611|039|H|mouth and gently press your finger on the outside of your upper||
1611|040|H|lip for 30 seconds. This will make the tablet stick to your gum.||
1611|041|H|The tablet will slowly dissolve over time and should be left in||
1611|042|H|place. You may eat and drink while using this medication. Do not||
1611|043|H|crush, chew, suck, or swallow the tablet.||
1611|044|H|   If the tablet does not stick to your upper gum or falls off||
1611|045|H|within the first 6 hours after you apply it, the same tablet||
1611|046|H|should be placed back onto your upper gum right away. If it still||
1611|047|H|does not stay in place, apply another acyclovir tablet to your||
1611|048|H|upper gum.||
1611|049|H|   If you accidentally swallow the tablet within the first 6||
1611|050|H|hours after placement, drink a glass of water and apply a new||
1611|051|H|dose to your gum. However, if the tablet has been in place 6||
1611|052|H|hours or longer and it falls out or you swallow it, do not||
1611|053|H|re-apply the tablet.||
1611|054|H|   Avoid doing things that may keep the buccal tablet from||
1611|055|H|sticking to your gum, including touching or pressing the tablet||
1611|056|H|after placement, wearing an upper denture that interferes with||
1611|057|H|tablet placement, chewing gum, and brushing your teeth while the||
1611|058|H|tablet is in place. You may gently rinse your mouth with water to||
1611|059|H|clean your teeth while the tablet is in place. Drink plenty of||
1611|060|H|liquids if you have dry mouth.||
1611|061|H|   This medication works best when started at the first sign of a||
1611|062|H|cold sore, as directed by your doctor. It may not work as well if||
1611|063|H|you delay treatment.||
1611|064|H|   Tell your doctor if your condition does not get better or if||
1611|065|H|it gets worse.||
1611|066|B|||
1611|067|S|SIDE EFFECTS:  Headache or pain at the application site may||
1611|068|S|occur. If either of these effects lasts or gets worse, tell your||
1611|069|S|doctor or pharmacist promptly.||
1611|070|S|   Remember that this medication has been prescribed because your||
1611|071|S|doctor has judged that the benefit to you is greater than the||
1611|072|S|risk of side effects. Many people using this medication do not||
1611|073|S|have serious side effects.||
1611|074|S|   A very serious allergic reaction to this drug is rare.||
1611|075|S|However, get medical help right away if you notice any symptoms||
1611|076|S|of a serious allergic reaction, including: fever, swollen lymph||
1611|077|S|nodes, rash, itching/swelling (especially of the||
1611|078|S|face/tongue/throat), severe dizziness, trouble breathing.||
1611|079|S|   This is not a complete list of possible side effects. If you||
1611|080|S|notice other effects not listed above, contact your doctor or||
1611|081|S|pharmacist.||
1611|082|S|   In the US -||
1611|083|S|   Call your doctor for medical advice about side effects. You||
1611|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1611|085|S|www.fda.gov/medwatch.||
1611|086|S|   In Canada - Call your doctor for medical advice about side||
1611|087|S|effects. You may report side effects to Health Canada at||
1611|088|S|1-866-234-2345.||
1611|089|B|||
1611|090|P|PRECAUTIONS:  Before using acyclovir, tell your doctor or||
1611|091|P|pharmacist if you are allergic to it; or to valacyclovir; or if||
1611|092|P|you have any other allergies. This product may contain inactive||
1611|093|P|ingredients, which can cause allergic reactions or other||
1611|094|P|problems. Talk to your pharmacist for more details.||
1611|095|P|   Before using this medication, tell your doctor or pharmacist||
1611|096|P|your medical history.||
1611|097|P|   Before having surgery, tell your doctor or dentist about all||
1611|098|P|the products you use (including prescription drugs,||
1611|099|P|nonprescription drugs, and herbal products).||
1611|100|P|   Tell your health care professional that you are using||
1611|101|P|acyclovir before having any immunizations/vaccinations (such as||
1611|102|P|vaccines against the varicella virus).||
1611|103|P|   During pregnancy, this medication should be used only when||
1611|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
1611|105|P|   It is unknown if this form of acyclovir passes into breast||
1611|106|P|milk. However, this medication is unlikely to harm a nursing||
1611|107|P|infant. Consult your doctor before breastfeeding.||
1611|108|B|||
1611|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1611|110|I|medications work or increase your risk for serious side effects.||
1611|111|I|This document does not contain all possible drug interactions.||
1611|112|I|Keep a list of all the products you use (including||
1611|113|I|prescription/nonprescription drugs and herbal products) and share||
1611|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
1611|115|I|the dosage of any medicines without your doctor's approval.||
1611|116|I|   Acyclovir is very similar to valacyclovir. Do not use||
1611|117|I|medications containing valacyclovir while using acyclovir.||
1611|118|B|||
1611|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1611|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1611|121|O|poison control center right away. US residents can call||
1611|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1611|123|B|||
1611|124|N|NOTES:  Do not share this medication with others.||
1611|125|N|   This medication has been prescribed for your current condition||
1611|126|N|only. Do not use it later for another infection unless your||
1611|127|N|doctor tells you to.||
1611|128|B|||
1611|129|D|MISSED DOSE:  Not applicable.||
1611|130|B|||
1611|131|R|STORAGE:  Store at room temperature away from light and moisture.||
1611|132|R|Do not store in the bathroom. Keep all medications away from||
1611|133|R|children and pets.||
1611|134|R|   Do not flush medications down the toilet or pour them into a||
1611|135|R|drain unless instructed to do so. Properly discard this product||
1611|136|R|when it is expired or no longer needed. Consult your pharmacist||
1611|137|R|or local waste disposal company.||
1611|138|B|||
1611|139|A|Information last revised November 2025.||
1611|140|A|Copyright(c) 2025 First Databank, Inc.||
1611|141|B|||
1612|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1612|002|Z|does NOT have all possible information about this product. This||
1612|003|Z|information does not assure that this product is safe, effective,||
1612|004|Z|or appropriate for you. This information is not individual||
1612|005|Z|medical advice and does not substitute for the advice of your||
1612|006|Z|health care professional. Always ask your health care||
1612|007|Z|professional for complete information about this product and your||
1612|008|Z|specific health needs.||
1612|009|B|||
1612|010|T|VEDOLIZUMAB - INJECTION||
1612|011|F|(VE-doe-LIZ-ue-mab)||
1612|012|B|||
1612|013|C|COMMON BRAND NAME(S): Entyvio||
1612|014|B|||
1612|015|U|USES:  This medication is used to treat certain bowel disorders||
1612|016|U|(ulcerative colitis, Crohn's disease). In these conditions, the||
1612|017|U|body's defense system (immune system) attacks healthy tissues in||
1612|018|U|the gut, causing symptoms such as abdominal pain, blood in the||
1612|019|U|stool, and diarrhea. Vedolizumab belongs to a class of drugs||
1612|020|U|known as monoclonal antibodies. It works by blocking the actions||
1612|021|U|of a certain natural substance (integrin) in the body. This helps||
1612|022|U|to decrease swelling (inflammation) in the gut, which lessens||
1612|023|U|symptoms and may slow or stop damage from these bowel disorders.||
1612|024|B|||
1612|025|H|HOW TO USE:  Read the Medication Guide provided by your||
1612|026|H|pharmacist before you start using vedolizumab and each time you||
1612|027|H|get a treatment. If you have any questions, ask your doctor or||
1612|028|H|pharmacist. Discuss the risks and benefits of vedolizumab||
1612|029|H|treatment.||
1612|030|H|   Before starting treatment with vedolizumab, you should be up||
1612|031|H|to date with all your vaccinations. Ask your doctor if you need||
1612|032|H|to receive any vaccines before starting vedolizumab.||
1612|033|H|   This medication is given by injection into a vein by a health||
1612|034|H|care professional. It should be injected slowly over 30 minutes.||
1612|035|H|After the first dose, you will usually receive the next two doses||
1612|036|H|2 weeks and 6 weeks later. After the third dose, this medication||
1612|037|H|is given as directed by your doctor, usually every 8 weeks.||
1612|038|H|   Infusion reactions can happen during the infusion of this drug||
1612|039|H|and for several hours afterward. Tell your doctor right away if||
1612|040|H|you have any symptoms of infusion reactions such as shortness of||
1612|041|H|breath, fast heartbeat, or flushing. Your doctor may stop your||
1612|042|H|treatment for some time.||
1612|043|H|   Use this medication regularly to get the most benefit from it.||
1612|044|H|To help you remember, mark your calendar with a reminder.||
1612|045|H|   Tell your doctor if your condition does not get better or if||
1612|046|H|it gets worse.||
1612|047|B|||
1612|048|S|SIDE EFFECTS:  See also How to Use section.||
1612|049|S|   Nausea, headache, flu/common cold symptoms, or tiredness may||
1612|050|S|occur. If any of these effects last or get worse, tell your||
1612|051|S|doctor or pharmacist promptly.||
1612|052|S|   Remember that this medication has been prescribed because your||
1612|053|S|doctor has judged that the benefit to you is greater than the||
1612|054|S|risk of side effects. Many people using this medication do not||
1612|055|S|have serious side effects.||
1612|056|S|   Tell your doctor right away if you have any serious side||
1612|057|S|effects, including: mouth/throat pain, pain in your arms/legs,||
1612|058|S|symptoms of liver damage (such as nausea/vomiting that doesn't||
1612|059|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
1612|060|S|eyes/skin, dark urine).||
1612|061|S|   This medication may lower your ability to fight infections.||
1612|062|S|This may make you more likely to get a serious (rarely fatal)||
1612|063|S|infection or make any infection you have worse. Tell your doctor||
1612|064|S|right away if you have any signs of infection (such as sore||
1612|065|S|throat that doesn't go away, fever, chills).||
1612|066|S|   This medication may increase your risk of getting a rare but||
1612|067|S|very serious (possibly fatal) brain infection (progressive||
1612|068|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1612|069|S|if you have any of these side effects: clumsiness, loss of||
1612|070|S|coordination/balance, weakness, sudden change in your thinking||
1612|071|S|(such as confusion, difficulty concentrating, memory loss),||
1612|072|S|difficulty talking/walking, seizure, vision changes.||
1612|073|S|   A very serious allergic reaction to this drug is rare.||
1612|074|S|However, get medical help right away if you notice any symptoms||
1612|075|S|of a serious allergic reaction, including: rash, itching/swelling||
1612|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1612|077|S|breathing.||
1612|078|S|   This is not a complete list of possible side effects. If you||
1612|079|S|notice other effects not listed above, contact your doctor or||
1612|080|S|pharmacist.||
1612|081|S|   In the US -||
1612|082|S|   Call your doctor for medical advice about side effects. You||
1612|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1612|084|S|www.fda.gov/medwatch.||
1612|085|S|   In Canada - Call your doctor for medical advice about side||
1612|086|S|effects. You may report side effects to Health Canada at||
1612|087|S|1-866-234-2345.||
1612|088|B|||
1612|089|P|PRECAUTIONS:  Before using vedolizumab, tell your doctor or||
1612|090|P|pharmacist if you are allergic to it; or if you have any other||
1612|091|P|allergies. This product may contain inactive ingredients, which||
1612|092|P|can cause allergic reactions or other problems. Talk to your||
1612|093|P|pharmacist for more details.||
1612|094|P|   Before using this medication, tell your doctor or pharmacist||
1612|095|P|your medical history, especially of: symptoms of infection (such||
1612|096|P|as fever, chills, sore throat, cough, runny nose),||
1612|097|P|current/past/returning infections (such as tuberculosis), cancer.||
1612|098|P|   Vedolizumab can make you more likely to get infections or may||
1612|099|P|make current infections worse. Stay away from anyone who has an||
1612|100|P|infection that may easily spread (such as chickenpox, COVID-19,||
1612|101|P|measles, flu). Talk to your doctor if you have been exposed to an||
1612|102|P|infection or for more details.||
1612|103|P|   Tell your doctor your vaccine history and ask if you need to||
1612|104|P|get any vaccines before starting treatment with this medication.||
1612|105|P|Tell your health care professional that you are using vedolizumab||
1612|106|P|before having any immunizations/vaccinations. Avoid contact with||
1612|107|P|people who have recently received live vaccines (such as flu||
1612|108|P|vaccine inhaled through the nose).||
1612|109|P|   Before having surgery, tell your doctor or dentist about all||
1612|110|P|the products you use (including prescription drugs,||
1612|111|P|nonprescription drugs, and herbal products).||
1612|112|P|   During pregnancy, this medication should be used only when||
1612|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
1612|114|P|Mothers who have used this medication during pregnancy should ask||
1612|115|P|a doctor about immunizations/vaccinations for their newborn||
1612|116|P|babies.||
1612|117|P|   This drug passes into breast milk. Consult your doctor before||
1612|118|P|breastfeeding.||
1612|119|B|||
1612|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1612|121|I|medications work or increase your risk for serious side effects.||
1612|122|I|This document does not contain all possible drug interactions.||
1612|123|I|Keep a list of all the products you use (including||
1612|124|I|prescription/nonprescription drugs and herbal products) and share||
1612|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1612|126|I|the dosage of any medicines without your doctor's approval.||
1612|127|I|   Some products that may interact with this drug include: other||
1612|128|I|drugs that weaken the immune system/increase the risk of||
1612|129|I|infection (such as natalizumab, rituximab, TNF blockers such as||
1612|130|I|adalimumab/infliximab).||
1612|131|B|||
1612|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1612|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1612|134|O|poison control center right away. US residents can call||
1612|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1612|136|B|||
1612|137|N|NOTES:  Lab and/or medical tests (such as endoscopy, liver||
1612|138|N|function) may be done while you are using this medication. Keep||
1612|139|N|all medical and lab appointments. Consult your doctor for more||
1612|140|N|details.||
1612|141|B|||
1612|142|D|MISSED DOSE:  It is important to get each dose of this medication||
1612|143|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1612|144|D|right away for a new dosing schedule.||
1612|145|B|||
1612|146|R|STORAGE:  Not applicable. This medication is given in a clinic||
1612|147|R|and will not be stored at home.||
1612|148|B|||
1612|149|M|MEDICAL ALERT:  Your condition can cause complications in a||
1612|150|M|medical emergency. For information about enrolling in MedicAlert,||
1612|151|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1612|152|B|||
1612|153|A|Information last revised November 2025.||
1612|154|A|Copyright(c) 2025 First Databank, Inc.||
1612|155|B|||
1613|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1613|002|Z|does NOT have all possible information about this product. This||
1613|003|Z|information does not assure that this product is safe, effective,||
1613|004|Z|or appropriate for you. This information is not individual||
1613|005|Z|medical advice and does not substitute for the advice of your||
1613|006|Z|health care professional. Always ask your health care||
1613|007|Z|professional for complete information about this product and your||
1613|008|Z|specific health needs.||
1613|009|B|||
1613|010|T|LEVOMEPROMAZINE (METHOTRIMEPRAZINE) - INJECTION||
1613|011|F|(LEE-voe-me-PROE-ma-zeen/METH-oh-trye-MEP-ra-zeen)||
1613|012|B|||
1613|013|W|WARNING:  There may be a slightly increased risk of serious,||
1613|014|W|possibly fatal side effects (such as heart failure,||
1613|015|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1613|016|W|by older adults with dementia. This medication is not approved||
1613|017|W|for the treatment of dementia-related behavior problems. Discuss||
1613|018|W|the risks and benefits of this medication, as well as other||
1613|019|W|effective and possibly safer treatments for dementia-related||
1613|020|W|behavior problems, with the doctor.||
1613|021|B|||
1613|022|U|USES:  Levomepromazine (also known as methotrimeprazine) is used||
1613|023|U|to treat certain mental/mood disorders (such as schizophrenia,||
1613|024|U|bipolar disorder). It is also used to treat a certain sleep||
1613|025|U|problem (insomnia), nausea/vomiting, and pain. Levomepromazine||
1613|026|U|belongs to a class of drugs known as antipsychotics. It works by||
1613|027|U|helping to restore the balance of certain natural substances in||
1613|028|U|the brain.||
1613|029|B|||
1613|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1613|031|H|from your pharmacist before you start using levomepromazine and||
1613|032|H|each time you get a refill. If you have any questions, ask your||
1613|033|H|doctor or pharmacist.||
1613|034|H|   This medication is given by injection into a muscle as||
1613|035|H|directed by your doctor. It may also be given by injection into a||
1613|036|H|vein. The dosage is based on your medical condition, age, and||
1613|037|H|response to treatment. Children's dosage is also based on weight.||
1613|038|H|   If you are using this medication at home, learn all||
1613|039|H|preparation and usage instructions from your health care||
1613|040|H|professional and the product package. Before using, check this||
1613|041|H|product for particles or discoloration. If either is present, do||
1613|042|H|not use the liquid. Learn how to store and discard medical||
1613|043|H|supplies safely.||
1613|044|H|   Use this medication regularly to get the most benefit from it.||
1613|045|H|To help you remember, use it at the same time(s) each day.||
1613|046|H|   Do not stop taking this medication without consulting your||
1613|047|H|doctor. Some conditions may become worse when this drug is||
1613|048|H|suddenly stopped. Your dose may need to be gradually decreased.||
1613|049|H|   Tell your doctor if your condition does not get better or if||
1613|050|H|it gets worse.||
1613|051|B|||
1613|052|S|SIDE EFFECTS:  See also Warning section.||
1613|053|S|   Dizziness, lightheadedness, drowsiness, constipation, dry||
1613|054|S|mouth, blurred vision, difficulty urinating, and weight gain may||
1613|055|S|occur. If any of these effects last or get worse, tell your||
1613|056|S|doctor or pharmacist promptly.||
1613|057|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
1613|058|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1613|059|S|substitute.||
1613|060|S|   Dizziness and lightheadedness can increase the risk of||
1613|061|S|falling. Get up slowly when rising from a sitting or lying||
1613|062|S|position. Your doctor may tell you to stay in bed for 1 to 2 days||
1613|063|S|when first starting this medication until your body gets used to||
1613|064|S|it and the dizziness lessens.||
1613|065|S|   Tell your doctor right away if any of these side effects||
1613|066|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
1613|067|S|mask-like expression of the face, drooling/trouble swallowing, or||
1613|068|S|shuffling walk. Your doctor may prescribe another medication to||
1613|069|S|decrease these side effects.||
1613|070|S|   Remember that this medication has been prescribed because your||
1613|071|S|doctor has judged that the benefit to you is greater than the||
1613|072|S|risk of side effects. Many people using this medication do not||
1613|073|S|have serious side effects.||
1613|074|S|   This medication may rarely make your blood sugar rise, which||
1613|075|S|can cause or worsen diabetes. Tell your doctor right away if you||
1613|076|S|have symptoms of high blood sugar such as increased||
1613|077|S|thirst/urination. If you already have diabetes, check your blood||
1613|078|S|sugar regularly as directed and share the results with your||
1613|079|S|doctor. Your doctor may need to adjust your diabetes medication,||
1613|080|S|exercise program, or diet.||
1613|081|S|   This medication may increase a certain natural substance||
1613|082|S|(prolactin) made by your body. For females, this increase in||
1613|083|S|prolactin may result in unwanted breast milk, missed/stopped||
1613|084|S|periods, or difficulty becoming pregnant. For males, it may||
1613|085|S|result in decreased sexual ability, inability to produce sperm,||
1613|086|S|or enlarged breasts. If you develop any of these symptoms, tell||
1613|087|S|your doctor right away.||
1613|088|S|   Rarely, males may have a painful or prolonged erection lasting||
1613|089|S|4 or more hours. If this occurs, stop using this drug and get||
1613|090|S|medical help right away, or permanent problems could occur.||
1613|091|S|   Levomepromazine may rarely cause a condition known as tardive||
1613|092|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1613|093|S|your doctor right away if you develop any unusual/uncontrolled||
1613|094|S|movements (especially of the face, lips, mouth, tongue, arms, or||
1613|095|S|legs).||
1613|096|S|   This medication may rarely cause a very serious condition||
1613|097|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1613|098|S|right away if you have any of the following symptoms: fever,||
1613|099|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1613|100|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1613|101|S|signs of kidney problems (such as change in the amount of urine).||
1613|102|S|   Tell your doctor right away if you have any serious side||
1613|103|S|effects, including: nausea/vomiting that doesn't stop, loss of||
1613|104|S|appetite, easy bleeding/bruising, signs of infection (such as||
1613|105|S|sore throat that doesn't go away, fever, chills),||
1613|106|S|stomach/abdominal pain, yellowing eyes/skin.||
1613|107|S|   Get medical help right away if you have any very serious side||
1613|108|S|effects, including: diarrhea that doesn't stop, sudden||
1613|109|S|pain/swelling/redness, severe dizziness, fainting, seizures,||
1613|110|S|blood/mucus in the stool.||
1613|111|S|   A very serious allergic reaction to this drug is rare.||
1613|112|S|However, get medical help right away if you notice any symptoms||
1613|113|S|of a serious allergic reaction, including: rash, itching/swelling||
1613|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1613|115|S|breathing.||
1613|116|S|   This is not a complete list of possible side effects. If you||
1613|117|S|notice other effects not listed above, contact your doctor or||
1613|118|S|pharmacist.||
1613|119|S|   In the US -||
1613|120|S|   Call your doctor for medical advice about side effects. You||
1613|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1613|122|S|www.fda.gov/medwatch.||
1613|123|S|   In Canada - Call your doctor for medical advice about side||
1613|124|S|effects. You may report side effects to Health Canada at||
1613|125|S|1-866-234-2345.||
1613|126|B|||
1613|127|P|PRECAUTIONS:  Before taking levomepromazine, tell your doctor or||
1613|128|P|pharmacist if you are allergic to it; or to other phenothiazines||
1613|129|P|(such as chlorpromazine); or if you have any other allergies.||
1613|130|P|This product may contain inactive ingredients, which can cause||
1613|131|P|allergic reactions or other problems. Talk to your pharmacist for||
1613|132|P|more details.||
1613|133|P|   Before using this medication, tell your doctor or pharmacist||
1613|134|P|your medical history, especially of: blood or blood clotting||
1613|135|P|problems (such as low white blood cell count, low platelets,||
1613|136|P|anemia, hemophilia), brain injury/tumor, a certain severe nervous||
1613|137|P|system problem (severe CNS depression), a certain adrenal gland||
1613|138|P|tumor (pheochromocytoma), a certain eye problem (glaucoma), heart||
1613|139|P|problems (such as angina, heart attack, fast/irregular||
1613|140|P|heartbeat), liver disease, Parkinson's disease, seizures,||
1613|141|P|difficulty urinating (such as due to prostate problems).||
1613|142|P|   Levomepromazine may cause a condition that affects the heart||
1613|143|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1613|144|P|serious (rarely fatal) fast/irregular heartbeat and other||
1613|145|P|symptoms (such as severe dizziness, fainting) that need medical||
1613|146|P|attention right away.||
1613|147|P|   The risk of QT prolongation may be increased if you have||
1613|148|P|certain medical conditions or are taking other drugs that may||
1613|149|P|cause QT prolongation. Before using levomepromazine, tell your||
1613|150|P|doctor or pharmacist of all the drugs you take and if you have||
1613|151|P|any of the following conditions: certain heart problems (heart||
1613|152|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1613|153|P|history of certain heart problems (QT prolongation in the EKG,||
1613|154|P|sudden cardiac death).||
1613|155|P|   Low levels of potassium or magnesium in the blood may also||
1613|156|P|increase your risk of QT prolongation. This risk may increase if||
1613|157|P|you use certain drugs (such as diuretics/"water pills") or if you||
1613|158|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1613|159|P|Talk to your doctor about using levomepromazine safely.||
1613|160|P|   This drug may make you dizzy or drowsy or blur your vision.||
1613|161|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1613|162|P|drowsy. Do not drive, use machinery, or do anything that needs||
1613|163|P|alertness or clear vision until you can do it safely. Avoid||
1613|164|P|alcoholic beverages. Talk to your doctor if you are using||
1613|165|P|marijuana (cannabis).||
1613|166|P|   This medication may make you more sensitive to the sun. Limit||
1613|167|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1613|168|P|sunscreen and wear protective clothing when outdoors. Tell your||
1613|169|P|doctor right away if you get sunburned or have skin||
1613|170|P|blisters/redness.||
1613|171|P|   This medication may make you sweat less, making you more||
1613|172|P|likely to get heat stroke. Avoid doing things that may cause you||
1613|173|P|to overheat, such as hard work or exercise in hot weather, or||
1613|174|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1613|175|P|and dress lightly. If you overheat, quickly look for a place to||
1613|176|P|cool down and rest. Get medical help right away if you have a||
1613|177|P|fever that does not go away, mental/mood changes, headache, or||
1613|178|P|dizziness.||
1613|179|P|   Before having procedures with injected dye (such as certain||
1613|180|P|X-ray procedures) or surgery, tell your doctor or dentist about||
1613|181|P|all the products you use (including prescription drugs,||
1613|182|P|nonprescription drugs, and herbal products).||
1613|183|P|   Older adults may be more sensitive to the side effects of this||
1613|184|P|drug, especially drowsiness, dizziness, lightheadedness,||
1613|185|P|difficulty urinating, severe constipation, and QT prolongation||
1613|186|P|(see above). Drowsiness, dizziness, and lightheadedness can||
1613|187|P|increase the risk of falling.||
1613|188|P|   During pregnancy, this medication should be used only when||
1613|189|P|clearly needed. Babies born to mothers who have used this drug||
1613|190|P|during the last 3 months of pregnancy may rarely develop symptoms||
1613|191|P|including muscle stiffness or shakiness, drowsiness,||
1613|192|P|feeding/breathing difficulties, or constant crying. If you notice||
1613|193|P|any of these symptoms in your newborn especially during their||
1613|194|P|first month, tell the doctor right away.||
1613|195|P|   Since untreated mental/mood problems (such as schizophrenia,||
1613|196|P|bipolar disorder) can be a serious condition, do not stop taking||
1613|197|P|this medication unless directed by your doctor. If you are||
1613|198|P|planning pregnancy, become pregnant, or think you may be||
1613|199|P|pregnant, immediately discuss with your doctor the benefits and||
1613|200|P|risks of using this medication during pregnancy.||
1613|201|P|   It is unknown if this drug passes into breast milk, but it may||
1613|202|P|have undesirable effects on a nursing infant. Consult your doctor||
1613|203|P|before breastfeeding.||
1613|204|B|||
1613|205|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1613|206|I|medications work or increase your risk for serious side effects.||
1613|207|I|This document does not contain all possible drug interactions.||
1613|208|I|Keep a list of all the products you use (including||
1613|209|I|prescription/nonprescription drugs and herbal products) and share||
1613|210|I|it with your doctor and pharmacist. Do not start, stop, or change||
1613|211|I|the dosage of any medicines without your doctor's approval.||
1613|212|I|   Many drugs besides levomepromazine may affect the heart rhythm||
1613|213|I|(QT prolongation), including dronedarone, pimozide, among others.||
1613|214|I|   Tell your doctor or pharmacist if you are taking other||
1613|215|I|products that cause drowsiness such as opioid pain or cough||
1613|216|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1613|217|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1613|218|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1613|219|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1613|220|I|diphenhydramine).||
1613|221|I|   Check the labels on all your medicines (such as allergy or||
1613|222|I|cough-and-cold products) because they may contain ingredients||
1613|223|I|that cause drowsiness. Ask your pharmacist about using those||
1613|224|I|products safely.||
1613|225|B|||
1613|226|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1613|227|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1613|228|O|poison control center right away. US residents can call||
1613|229|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1613|230|O|Symptoms of overdose may include: severe muscle spasms, deep||
1613|231|O|sleep, loss of consciousness, seizures.||
1613|232|B|||
1613|233|N|NOTES:  Do not share this medication with others.||
1613|234|N|   Lab and/or medical tests (such as complete blood count, blood||
1613|235|N|sugar, weight) should be done before you start using this||
1613|236|N|medication and while you are using it. Keep all medical and lab||
1613|237|N|appointments. Consult your doctor for more details.||
1613|238|B|||
1613|239|D|MISSED DOSE:  It is important to get each dose of this medication||
1613|240|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1613|241|D|right away for a new dosing schedule. Do not double the dose to||
1613|242|D|catch up.||
1613|243|B|||
1613|244|R|STORAGE:  Store at room temperature away from light. Keep all||
1613|245|R|medications away from children and pets.||
1613|246|R|   Do not flush medications down the toilet or pour them into a||
1613|247|R|drain unless instructed to do so. Properly discard this product||
1613|248|R|when it is expired or no longer needed. Consult your pharmacist||
1613|249|R|or local waste disposal company.||
1613|250|B|||
1613|251|A|Information last revised April 2025.||
1613|252|A|Copyright(c) 2025 First Databank, Inc.||
1613|253|B|||
1614|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1614|002|Z|does NOT have all possible information about this product. This||
1614|003|Z|information does not assure that this product is safe, effective,||
1614|004|Z|or appropriate for you. This information is not individual||
1614|005|Z|medical advice and does not substitute for the advice of your||
1614|006|Z|health care professional. Always ask your health care||
1614|007|Z|professional for complete information about this product and your||
1614|008|Z|specific health needs.||
1614|009|B|||
1614|010|T|PROPRANOLOL SOLUTION PEDIATRIC - ORAL||
1614|011|F|(proe-PRAN-oh-lol)||
1614|012|B|||
1614|013|C|COMMON BRAND NAME(S): Hemangeol||
1614|014|B|||
1614|015|U|USES:  This formulation of propranolol is used for infants and||
1614|016|U|children to treat a certain benign tumor (proliferating infantile||
1614|017|U|hemangioma). It helps to shrink the tumor. Propranolol belongs to||
1614|018|U|a class of drugs known as beta blockers.||
1614|019|B|||
1614|020|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1614|021|H|Leaflet provided by your pharmacist before you start giving||
1614|022|H|propranolol to your child and each time you get a refill. If you||
1614|023|H|have any questions, ask the doctor or pharmacist.||
1614|024|H|   Give this medication to your child by mouth as directed by the||
1614|025|H|doctor, usually 2 times daily (at least 9 hours apart). This||
1614|026|H|medication should be given during or right after a meal/feeding.||
1614|027|H|Skip the dose of the medication if your child is not eating or is||
1614|028|H|vomiting.||
1614|029|H|   Do not shake the bottle before use. Carefully measure the dose||
1614|030|H|using a special measuring device/oral syringe. Do not use a||
1614|031|H|household spoon because you may not get the correct dose. You may||
1614|032|H|give this medication directly into the child's mouth with the||
1614|033|H|oral syringe or the medication can be mixed in a small amount of||
1614|034|H|milk or fruit juice and then given to the child. If you are||
1614|035|H|unsure if your child swallowed the full dose of the medication or||
1614|036|H|if your child spits up the dose, do not give another dose, but||
1614|037|H|wait for the next scheduled dose.||
1614|038|H|   The dosage is based on your child's medical condition, weight,||
1614|039|H|and response to treatment. To reduce the risk of side effects,||
1614|040|H|the doctor may direct your child to start this medication at a||
1614|041|H|low dose and gradually increase the dose. The dosage may be||
1614|042|H|increased by the doctor as your child gains weight. Follow the||
1614|043|H|doctor's instructions carefully. The blood pressure and heart||
1614|044|H|rate should be monitored for 2 hours when the medication is first||
1614|045|H|started and after each dose increase.||
1614|046|H|   If your child also takes certain drugs to lower cholesterol||
1614|047|H|(bile acid-binding resins such as cholestyramine or colestipol),||
1614|048|H|give propranolol at least 1 hour before or at least 4 hours after||
1614|049|H|these medications.||
1614|050|H|   Use this medication regularly to get the most benefit from it.||
1614|051|H|To help you remember, give it at the same times each day.||
1614|052|H|   Tell the doctor if your child's condition does not get better||
1614|053|H|or if it gets worse.||
1614|054|B|||
1614|055|S|SIDE EFFECTS:  Dizziness, lightheadedness, or tiredness may occur||
1614|056|S|as the body adjusts to the medication. Diarrhea,||
1614|057|S|stomach/abdominal pain, decreased appetite, vomiting, trouble||
1614|058|S|sleeping, and unusual dreams may also occur. If any of these||
1614|059|S|effects last or get worse, tell the doctor or pharmacist||
1614|060|S|promptly.||
1614|061|S|   This drug may reduce blood flow to the hands and feet, causing||
1614|062|S|them to feel cold. Tell the doctor if this occurs. Dress your||
1614|063|S|child warmly.||
1614|064|S|   Remember that this medication has been prescribed because the||
1614|065|S|doctor has judged that the benefit to your child is greater than||
1614|066|S|the risk of side effects. Many people using this medication do||
1614|067|S|not have serious side effects.||
1614|068|S|   Tell the doctor right away if your child has any serious side||
1614|069|S|effects, including: fainting, pale/blue/purple skin, new or||
1614|070|S|worsening symptoms of heart failure (such as shortness of breath,||
1614|071|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
1614|072|S|gain), very slow heartbeat, irregular heartbeat, signs of||
1614|073|S|infection (such as sore throat that doesn't go away, fever,||
1614|074|S|chills), mental/mood changes (such as agitation).||
1614|075|S|   This product may cause low blood sugar (hypoglycemia),||
1614|076|S|especially if your child is sick, not eating regularly, or is||
1614|077|S|vomiting. Symptoms of low blood sugar include sudden sweating,||
1614|078|S|shaking, fast heartbeat, hunger, blurred vision, dizziness,||
1614|079|S|seizures, or weakness. This product may prevent some of the||
1614|080|S|symptoms of hypoglycemia (such as fast/pounding heartbeat). Other||
1614|081|S|symptoms of low blood sugar, such as dizziness and sweating, are||
1614|082|S|not affected by this drug. If your child has symptoms of||
1614|083|S|hypoglycemia, tell the doctor right away.||
1614|084|S|   This medication may increase the risk of stroke in certain||
1614|085|S|children with a large hemangioma on their face or head. Get||
1614|086|S|medical help right away if your child has symptoms of a stroke,||
1614|087|S|including: trouble speaking, weakness on one side of the body,||
1614|088|S|sudden vision changes, confusion.||
1614|089|S|   A very serious allergic reaction to this drug is rare.||
1614|090|S|However, get medical help right away if you notice any symptoms||
1614|091|S|of a serious allergic reaction, including: rash, itching/swelling||
1614|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1614|093|S|breathing.||
1614|094|S|   This is not a complete list of possible side effects. If you||
1614|095|S|notice other effects not listed above, contact your doctor or||
1614|096|S|pharmacist.||
1614|097|S|   In the US -||
1614|098|S|   Call your doctor for medical advice about side effects. You||
1614|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1614|100|S|www.fda.gov/medwatch.||
1614|101|S|   In Canada - Call your doctor for medical advice about side||
1614|102|S|effects. You may report side effects to Health Canada at||
1614|103|S|1-866-234-2345.||
1614|104|B|||
1614|105|P|PRECAUTIONS:  See also Side Effects section.||
1614|106|P|   Before using propranolol, tell the doctor or pharmacist if||
1614|107|P|your child is allergic to it; or if your child has had a serious||
1614|108|P|reaction to other beta blockers (such as metoprolol); or if you||
1614|109|P|have any other allergies. This product may contain inactive||
1614|110|P|ingredients, which can cause allergic reactions or other||
1614|111|P|problems. Talk to your pharmacist for more details.||
1614|112|P|   Before using this medication, tell the doctor or pharmacist||
1614|113|P|your child's medical history, especially of: breathing problems||
1614|114|P|(such as asthma), certain heart problems (such as heart failure,||
1614|115|P|slow heart rate, second- or third-degree atrioventricular block),||
1614|116|P|severe allergic reactions, a certain adrenal gland tumor||
1614|117|P|(pheochromocytoma), very low blood pressure.||
1614|118|P|   Before having surgery, tell the doctor or dentist about all||
1614|119|P|the products your child uses (including prescription drugs,||
1614|120|P|nonprescription drugs, and herbal products).||
1614|121|P|   This drug may make your child dizzy. Do not let your child do||
1614|122|P|anything that needs alertness until you are sure that your child||
1614|123|P|can do it safely.||
1614|124|P|   This formulation of propranolol is not usually used by adults.||
1614|125|P|It is unlikely to be used during pregnancy or breastfeeding.||
1614|126|P|Consult your doctor if you have any questions about this||
1614|127|P|medication.||
1614|128|B|||
1614|129|I|DRUG INTERACTIONS:  See also How to Use section.||
1614|130|I|   Drug interactions may change how medications work or increase||
1614|131|I|the risk for serious side effects. This document does not contain||
1614|132|I|all possible drug interactions. Keep a list of all the products||
1614|133|I|your child uses (including prescription/nonprescription drugs and||
1614|134|I|herbal products) and share it with the doctor and pharmacist. Do||
1614|135|I|not start, stop, or change the dosage of any medicines without||
1614|136|I|the doctor's approval.||
1614|137|I|   Some products that may interact with this drug are:||
1614|138|I|epinephrine, fingolimod.||
1614|139|I|   Other medications can affect the removal of propranolol from||
1614|140|I|your body, which may affect how propranolol works. Examples||
1614|141|I|include quinidine, rifamycins (such as rifabutin), among others.||
1614|142|I|   This medication can slow down the removal of other medications||
1614|143|I|from your body, which may affect how they work. Examples of||
1614|144|I|affected drugs include fezolinetant, propafenone, thioridazine,||
1614|145|I|among others.||
1614|146|I|   If you are breastfeeding your child, ask the doctor if any||
1614|147|I|medications that you are using may pass into the breast milk and||
1614|148|I|interact with this medication.||
1614|149|B|||
1614|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1614|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1614|152|O|poison control center right away. US residents can call||
1614|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1614|154|O|Symptoms of overdose may include: very slow heartbeat, severe||
1614|155|O|dizziness, fainting, mental/mood changes (such as restlessness),||
1614|156|O|seizure.||
1614|157|B|||
1614|158|N|NOTES:  Do not share this medication with others.||
1614|159|N|   Have your child's blood pressure and pulse (heart rate)||
1614|160|N|checked regularly while taking this medication, especially when||
1614|161|N|this medication is first started or after a dose increase. If||
1614|162|N|directed by the doctor, learn how to monitor your child's blood||
1614|163|N|pressure and pulse at home, and share the results with the||
1614|164|N|doctor.||
1614|165|B|||
1614|166|D|MISSED DOSE:  If you miss a dose, give it as soon as you||
1614|167|D|remember. If it is near the time of the next dose, skip the||
1614|168|D|missed dose. Give the next dose at the regular time. Do not||
1614|169|D|double the dose to catch up.||
1614|170|B|||
1614|171|R|STORAGE:  Store at room temperature. Do not freeze. Once the||
1614|172|R|bottle is opened, this medication expires after 2 months. Keep||
1614|173|R|all medications away from children and pets.||
1614|174|R|   Do not flush medications down the toilet or pour them into a||
1614|175|R|drain unless instructed to do so. Properly discard this product||
1614|176|R|when it is expired or no longer needed. Consult your pharmacist||
1614|177|R|or local waste disposal company.||
1614|178|B|||
1614|179|M|MEDICAL ALERT:  Your condition can cause complications in a||
1614|180|M|medical emergency. For information about enrolling in MedicAlert,||
1614|181|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1614|182|B|||
1614|183|A|Information last revised April 2025.||
1614|184|A|Copyright(c) 2025 First Databank, Inc.||
1614|185|B|||
1615|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1615|002|Z|does NOT have all possible information about this product. This||
1615|003|Z|information does not assure that this product is safe, effective,||
1615|004|Z|or appropriate for you. This information is not individual||
1615|005|Z|medical advice and does not substitute for the advice of your||
1615|006|Z|health care professional. Always ask your health care||
1615|007|Z|professional for complete information about this product and your||
1615|008|Z|specific health needs.||
1615|009|B|||
1615|010|T|NORETHINDRONE/ETHINYL ESTRADIOL 24/2/2 - ORAL||
1615|011|F|(nor-ETH-in-drone/ETH-i-nil ES-tra-DYE-ol)||
1615|012|B|||
1615|013|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
1615|014|W|tobacco and are over 35 years old. Smoking raises your risk of||
1615|015|W|stroke, heart attack, blood clots, and high blood pressure from||
1615|016|W|hormonal birth control (such as the pill, patch, ring). The risk||
1615|017|W|of these serious problems increases with age and with the number||
1615|018|W|of cigarettes you smoke. Do not smoke or use tobacco.||
1615|019|B|||
1615|020|U|USES:  This combination hormone medication is used to prevent||
1615|021|U|pregnancy. It contains 2 hormones: norethindrone (a progestin)||
1615|022|U|and ethinyl estradiol (an estrogen).||
1615|023|U|   This product also contains inactive tablets taken during the||
1615|024|U|fourth week. The inactive pills do not contain any hormones.||
1615|025|U|These tablets are meant to keep you in the habit of taking 1||
1615|026|U|tablet each day.||
1615|027|U|   Besides preventing pregnancy, birth control pills may make||
1615|028|U|your periods more regular, decrease blood loss and painful||
1615|029|U|periods, decrease the risk of ovarian cysts, and also treat acne.||
1615|030|U|   This medication does not protect against sexually transmitted||
1615|031|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1615|032|U|an effective barrier method (latex or polyurethane condom/dental||
1615|033|U|dams) during sexual activity will help to decrease your risk of||
1615|034|U|infection.||
1615|035|B|||
1615|036|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1615|037|H|your pharmacist before you start taking this product and each||
1615|038|H|time you get a refill. The leaflet contains very important||
1615|039|H|information on when to take your pills and what to do if you miss||
1615|040|H|a dose. If you have any questions, ask your doctor or pharmacist.||
1615|041|H|   Take this medication by mouth with or without food as directed||
1615|042|H|by your doctor, usually once daily. Pick a time of day that is||
1615|043|H|easy for you to remember, and take your pill at the same time||
1615|044|H|each day.||
1615|045|H|   It is very important to keep taking this medication exactly as||
1615|046|H|prescribed by your doctor. Follow the package instructions to||
1615|047|H|find the first tablet, start with the first tablet in the pack,||
1615|048|H|and take them in the correct order. Do not skip any doses.||
1615|049|H|Pregnancy is more likely if you miss pills, start a new pack||
1615|050|H|late, or take your pill at a different time of the day than||
1615|051|H|usual.||
1615|052|H|   If you have vomiting or diarrhea within 3 to 4 hours after||
1615|053|H|taking your tablet, read the Patient Information Leaflet for||
1615|054|H|instructions. Follow the instructions for what to do, because||
1615|055|H|your pills may not work as well. You may need to use backup birth||
1615|056|H|control (such as condoms) to prevent pregnancy. Ask your doctor||
1615|057|H|or pharmacist if you have any questions.||
1615|058|H|   Taking this medication after your evening meal or at bedtime||
1615|059|H|may help if you have stomach upset or nausea with the medication.||
1615|060|H|You may choose to take this medication at another time of day||
1615|061|H|that is easier for you to remember. No matter what dosing||
1615|062|H|schedule you use, it is very important that you take this||
1615|063|H|medication at the same time each day, 24 hours apart.||
1615|064|H|   Your pill pack contains 26 pills with active medication (24||
1615|065|H|pills with norethindrone and ethinyl estradiol, 2 pills with only||
1615|066|H|ethinyl estradiol). It also contains 2 reminder pills. Take one||
1615|067|H|active pill (with hormones) once daily for 26 days in a row.||
1615|068|H|After you have taken the last active pill, take one reminder pill||
1615|069|H|once daily for 2 days in a row unless otherwise directed by your||
1615|070|H|doctor. You should have your period during the fourth week of the||
1615|071|H|cycle. After you have taken the last reminder tablet in the pack,||
1615|072|H|start a new pack the next day even if your period is continuing||
1615|073|H|or if you do not have your period. If you do not get your period,||
1615|074|H|consult your doctor.||
1615|075|H|   If this is the first time you are using this medication and||
1615|076|H|you are not switching from another form of hormonal birth control||
1615|077|H|(such as patch, other birth control pills), take the first tablet||
1615|078|H|in the pack on the first Sunday following the beginning of your||
1615|079|H|menstrual period or on the first day of your period. If your||
1615|080|H|period begins on a Sunday, begin taking this medication on that||
1615|081|H|day. For the first cycle of use only, use a backup form of||
1615|082|H|non-hormonal birth control (such as condoms, spermicide) for the||
1615|083|H|first 7 days to prevent pregnancy until the medication has enough||
1615|084|H|time to work. If you start on the first day of your period, you||
1615|085|H|do not need to use backup birth control the first week.||
1615|086|H|   Ask your doctor or pharmacist for information about how to||
1615|087|H|switch from other forms of hormonal birth control (such as patch,||
1615|088|H|other birth control pills) to this product. If any information is||
1615|089|H|unclear, consult the Patient Information Leaflet or your doctor||
1615|090|H|or pharmacist.||
1615|091|B|||
1615|092|S|SIDE EFFECTS:  Nausea, vomiting, headache, abdominal||
1615|093|S|cramps/bloating, breast tenderness, swelling of the ankles/feet||
1615|094|S|(retaining fluid), or weight change may occur. Vaginal bleeding||
1615|095|S|between periods (spotting) or missed/irregular periods may occur,||
1615|096|S|especially during the first few months of use. If any of these||
1615|097|S|effects last or get worse, tell your doctor or pharmacist||
1615|098|S|promptly. If you miss 2 periods in a row (or 1 period if the pill||
1615|099|S|has not been used properly), contact your doctor for a pregnancy||
1615|100|S|test.||
1615|101|S|   Remember that this medication has been prescribed because your||
1615|102|S|doctor has judged that the benefit to you is greater than the||
1615|103|S|risk of side effects. Many people using this medication do not||
1615|104|S|have serious side effects.||
1615|105|S|   This medication may raise your blood pressure. Check your||
1615|106|S|blood pressure regularly and tell your doctor if the results are||
1615|107|S|high.||
1615|108|S|   Tell your doctor right away if you have any serious side||
1615|109|S|effects, including: a lump in your breast, mental/mood changes||
1615|110|S|(such as new/worsening depression), unusual changes in vaginal||
1615|111|S|bleeding (such as continuous spotting, sudden heavy bleeding),||
1615|112|S|dark urine, severe stomach/abdominal pain, yellowing eyes/skin.||
1615|113|S|   This medication may rarely cause serious (sometimes fatal)||
1615|114|S|problems from blood clots (such as heart attack, stroke, blood||
1615|115|S|clots in the lungs or legs). Get medical help right away if you||
1615|116|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1615|117|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
1615|118|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1615|119|S|trouble speaking, weakness on one side of the body, sudden vision||
1615|120|S|changes.||
1615|121|S|   A very serious allergic reaction to this drug is rare.||
1615|122|S|However, get medical help right away if you notice any symptoms||
1615|123|S|of a serious allergic reaction, including: rash, itching/swelling||
1615|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1615|125|S|breathing.||
1615|126|S|   This is not a complete list of possible side effects. If you||
1615|127|S|notice other effects not listed above, contact your doctor or||
1615|128|S|pharmacist.||
1615|129|S|   In the US -||
1615|130|S|   Call your doctor for medical advice about side effects. You||
1615|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1615|132|S|www.fda.gov/medwatch.||
1615|133|S|   In Canada - Call your doctor for medical advice about side||
1615|134|S|effects. You may report side effects to Health Canada at||
1615|135|S|1-866-234-2345.||
1615|136|B|||
1615|137|P|PRECAUTIONS:  See also Warning section.||
1615|138|P|   Before using this medication, tell your doctor or pharmacist||
1615|139|P|if you are allergic to estradiol or norethindrone; or to any||
1615|140|P|estrogens (such as mestranol) or any progestins (such as||
1615|141|P|desogestrel); or if you have any other allergies. This product||
1615|142|P|may contain inactive ingredients, which can cause allergic||
1615|143|P|reactions or other problems. Talk to your pharmacist for more||
1615|144|P|details.||
1615|145|P|   Before using this product, tell your doctor or pharmacist your||
1615|146|P|medical history, especially of: blood clots (for example, in the||
1615|147|P|legs, eyes, lungs), blood clotting disorders (such as protein C||
1615|148|P|or protein S deficiency), high blood pressure, abnormal breast||
1615|149|P|exam, cancer (especially breast or endometrial cancer), high||
1615|150|P|cholesterol or triglyceride (blood fat) levels, depression,||
1615|151|P|diabetes, family or personal history of a certain swelling||
1615|152|P|disorder (angioedema), gallbladder problems, severe||
1615|153|P|headaches/migraines, heart problems (such as heart valve disease,||
1615|154|P|irregular heartbeat, previous heart attack), history of yellowing||
1615|155|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
1615|156|P|birth control (such as pills, patch), kidney disease, liver||
1615|157|P|disease (including tumors), stroke or "mini-stroke" (transient||
1615|158|P|ischemic attack), swelling (edema), thyroid problems, unexplained||
1615|159|P|vaginal bleeding, obesity.||
1615|160|P|   If you have diabetes, this medication may make it harder to||
1615|161|P|control your blood sugar. Check your blood sugar regularly as||
1615|162|P|directed and share the results with your doctor. Tell your doctor||
1615|163|P|right away if you have symptoms of high blood sugar such as||
1615|164|P|increased thirst/urination. Your doctor may need to adjust your||
1615|165|P|diabetes medication, exercise program, or diet.||
1615|166|P|   Tell your doctor if you just had or will be having surgery or||
1615|167|P|if you will be confined to a bed or chair for a long time (such||
1615|168|P|as on a long plane flight). These conditions increase your risk||
1615|169|P|of getting blood clots, especially if you are using hormonal||
1615|170|P|birth control. You may need to stop this medication for a time or||
1615|171|P|take special precautions.||
1615|172|P|   Before having surgery, tell your doctor or dentist about all||
1615|173|P|the products you use (including prescription drugs,||
1615|174|P|nonprescription drugs, and herbal products).||
1615|175|P|   This medication may cause blotchy, dark areas on your face and||
1615|176|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
1615|177|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
1615|178|P|wear protective clothing when outdoors.||
1615|179|P|   If you are nearsighted or wear contact lenses, you may develop||
1615|180|P|vision problems or trouble wearing your contact lenses. Contact||
1615|181|P|your eye doctor if these problems occur.||
1615|182|P|   It may take longer for you to become pregnant after you stop||
1615|183|P|taking birth control pills. Consult your doctor.||
1615|184|P|   This medication should not be used during pregnancy. If you||
1615|185|P|become pregnant or think you may be pregnant, tell your doctor||
1615|186|P|right away. If you have just given birth or had a pregnancy loss||
1615|187|P|or abortion after the first 3 months, talk with your doctor about||
1615|188|P|reliable forms of birth control, and find out when it is safe to||
1615|189|P|start using birth control that contains a form of estrogen, such||
1615|190|P|as this medication.||
1615|191|P|   A small amount of this medication passes into breast milk and||
1615|192|P|may have undesirable effects on a nursing infant. Consult your||
1615|193|P|doctor before breastfeeding.||
1615|194|B|||
1615|195|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1615|196|I|medications work or increase your risk for serious side effects.||
1615|197|I|This document does not contain all possible drug interactions.||
1615|198|I|Keep a list of all the products you use (including||
1615|199|I|prescription/nonprescription drugs and herbal products) and share||
1615|200|I|it with your doctor and pharmacist. Do not start, stop, or change||
1615|201|I|the dosage of any medicines without your doctor's approval.||
1615|202|I|   Some products that may interact with this drug include:||
1615|203|I|aromatase inhibitors (such as anastrozole, exemestane,||
1615|204|I|letrozole), fezolinetant, ospemifene, tamoxifen, tranexamic acid.||
1615|205|I|   Some drugs may cause hormonal birth control to work less well||
1615|206|I|by decreasing the amount of birth control hormones in your body.||
1615|207|I|This effect can result in pregnancy. Examples include||
1615|208|I|griseofulvin, modafinil, rifamycins (such as rifampin),||
1615|209|I|ritonavir, St. John's wort, drugs used to treat seizures (such as||
1615|210|I|barbiturates, carbamazepine, felbamate, phenytoin, primidone,||
1615|211|I|topiramate), HIV drugs (such as nelfinavir, nevirapine), among||
1615|212|I|others.||
1615|213|I|   Tell your doctor when you start any new drug, and discuss if||
1615|214|I|you should use reliable backup birth control. Also tell your||
1615|215|I|doctor if you have any new spotting or breakthrough bleeding,||
1615|216|I|because these may be signs that your birth control is not working||
1615|217|I|well.||
1615|218|I|   This medication may interfere with certain lab tests (such as||
1615|219|I|blood tests for clotting factors, thyroid), possibly causing||
1615|220|I|false test results. Make sure lab personnel and all your doctors||
1615|221|I|know you use this drug.||
1615|222|B|||
1615|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1615|224|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1615|225|O|poison control center right away. US residents can call||
1615|226|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1615|227|O|Symptoms of overdose may include: severe nausea and vomiting,||
1615|228|O|sudden/unusual vaginal bleeding.||
1615|229|B|||
1615|230|N|NOTES:  Do not share this medication with others.||
1615|231|N|   Regular complete physical exams which include lab and/or||
1615|232|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
1615|233|N|Pap smear) should be done while you are taking this medication.||
1615|234|N|Follow your doctor's instructions for examining your breasts, and||
1615|235|N|report any lumps right away. Keep all medical and lab||
1615|236|N|appointments. Consult your doctor for more details.||
1615|237|B|||
1615|238|D|MISSED DOSE:  Missed dose advice is different depending on the||
1615|239|D|brand used and the number of doses missed. Refer to the product||
1615|240|D|package information for advice on missed doses. You may need to||
1615|241|D|use backup birth control (such as condoms, spermicide) to prevent||
1615|242|D|pregnancy. Ask your doctor or pharmacist if you have any||
1615|243|D|questions.||
1615|244|D|   If you often forget to take your pills as directed, contact||
1615|245|D|your doctor to discuss switching to another form of birth||
1615|246|D|control.||
1615|247|B|||
1615|248|R|STORAGE:  Store at room temperature away from light and moisture.||
1615|249|R|Do not store in the bathroom. Keep all medications away from||
1615|250|R|children and pets.||
1615|251|R|   Do not flush medications down the toilet or pour them into a||
1615|252|R|drain unless instructed to do so. Properly discard this product||
1615|253|R|when it is expired or no longer needed. Consult your pharmacist||
1615|254|R|or local waste disposal company.||
1615|255|B|||
1615|256|A|Information last revised October 2025.||
1615|257|A|Copyright(c) 2025 First Databank, Inc.||
1615|258|B|||
1619|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1619|002|Z|does NOT have all possible information about this product. This||
1619|003|Z|information does not assure that this product is safe, effective,||
1619|004|Z|or appropriate for you. This information is not individual||
1619|005|Z|medical advice and does not substitute for the advice of your||
1619|006|Z|health care professional. Always ask your health care||
1619|007|Z|professional for complete information about this product and your||
1619|008|Z|specific health needs.||
1619|009|B|||
1619|010|T|DALBAVANCIN - INJECTION||
1619|011|F|(DAL-ba-VAN-sin)||
1619|012|B|||
1619|013|C|COMMON BRAND NAME(S): Dalvance||
1619|014|B|||
1619|015|U|USES:  This medication is used to treat serious bacterial||
1619|016|U|infections of the skin. It works by stopping the growth of||
1619|017|U|bacteria.||
1619|018|B|||
1619|019|H|HOW TO USE:  This medication is given by injection into a vein as||
1619|020|H|directed by your doctor, usually as one or two doses. If your||
1619|021|H|doctor prescribes 2 doses, the second dose is usually given one||
1619|022|H|week after the first dose. This medication should be injected||
1619|023|H|slowly over 30 minutes. The dosage is based on your medical||
1619|024|H|condition and response to treatment. Children's dosage is also||
1619|025|H|based on age and weight.||
1619|026|H|   If you are using this medication at home, learn all||
1619|027|H|preparation and usage instructions from your health care||
1619|028|H|professional and the product package. Before using, check this||
1619|029|H|product for particles or discoloration. If either is present, do||
1619|030|H|not use the liquid. Learn how to store and discard medical||
1619|031|H|supplies safely.||
1619|032|H|   Infusion reactions may happen during the infusion of this drug||
1619|033|H|if this drug is injected too fast. Tell your doctor right away if||
1619|034|H|you have any symptoms of infusion reactions such as flushing of||
1619|035|H|the upper body or back pain. Your doctor may slow down or stop||
1619|036|H|your treatment for some time.||
1619|037|H|   Continue to use this medication until the full prescribed||
1619|038|H|amount is finished, even if symptoms disappear after a few days.||
1619|039|H|Stopping the medication too early may result in a return of the||
1619|040|H|infection.||
1619|041|H|   Tell your doctor if your condition does not get better or if||
1619|042|H|it gets worse.||
1619|043|B|||
1619|044|S|SIDE EFFECTS:  See also How to Use section.||
1619|045|S|   Nausea, headache, and diarrhea may occur. If any of these||
1619|046|S|effects last or get worse, tell your doctor or pharmacist||
1619|047|S|promptly.||
1619|048|S|   Remember that this medication has been prescribed because your||
1619|049|S|doctor has judged that the benefit to you is greater than the||
1619|050|S|risk of side effects. Many people using this medication do not||
1619|051|S|have serious side effects.||
1619|052|S|   Tell your doctor right away if you have any serious side||
1619|053|S|effects, including: nausea/vomiting that doesn't stop, loss of||
1619|054|S|appetite, dark urine, yellowing eyes/skin.||
1619|055|S|   This medication may rarely cause a severe intestinal condition||
1619|056|S|due to a bacteria called C. difficile. This condition may occur||
1619|057|S|during treatment or weeks to months after treatment has stopped.||
1619|058|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1619|059|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1619|060|S|stool.||
1619|061|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1619|062|S|products because they may make symptoms worse.||
1619|063|S|   Use of this medication for prolonged or repeated periods may||
1619|064|S|result in oral thrush or a new yeast infection. Contact your||
1619|065|S|doctor if you notice white patches in your mouth, a change in||
1619|066|S|vaginal discharge, or other new symptoms.||
1619|067|S|   A very serious allergic reaction to this drug is rare.||
1619|068|S|However, get medical help right away if you notice any symptoms||
1619|069|S|of a serious allergic reaction, including: rash, itching/swelling||
1619|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1619|071|S|breathing.||
1619|072|S|   This is not a complete list of possible side effects. If you||
1619|073|S|notice other effects not listed above, contact your doctor or||
1619|074|S|pharmacist.||
1619|075|S|   In the US -||
1619|076|S|   Call your doctor for medical advice about side effects. You||
1619|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1619|078|S|www.fda.gov/medwatch.||
1619|079|S|   In Canada - Call your doctor for medical advice about side||
1619|080|S|effects. You may report side effects to Health Canada at||
1619|081|S|1-866-234-2345.||
1619|082|B|||
1619|083|P|PRECAUTIONS:  Before using dalbavancin, tell your doctor or||
1619|084|P|pharmacist if you are allergic to it; or if you have any other||
1619|085|P|allergies. This product may contain inactive ingredients, which||
1619|086|P|can cause allergic reactions or other problems. Talk to your||
1619|087|P|pharmacist for more details.||
1619|088|P|   Before using this medication, tell your doctor or pharmacist||
1619|089|P|your medical history, especially of: kidney disease.||
1619|090|P|   Dalbavancin may cause live bacterial vaccines (such as typhoid||
1619|091|P|vaccine) not to work well. Tell your health care professional||
1619|092|P|that you are using dalbavancin before having any||
1619|093|P|immunizations/vaccinations.||
1619|094|P|   Before having surgery, tell your doctor or dentist about all||
1619|095|P|the products you use (including prescription drugs,||
1619|096|P|nonprescription drugs, and herbal products).||
1619|097|P|   During pregnancy, this medication should be used only when||
1619|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
1619|099|P|   It is unknown if this medication passes into breast milk.||
1619|100|P|Consult your doctor before breastfeeding.||
1619|101|B|||
1619|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1619|103|I|medications work or increase your risk for serious side effects.||
1619|104|I|This document does not contain all possible drug interactions.||
1619|105|I|Keep a list of all the products you use (including||
1619|106|I|prescription/nonprescription drugs and herbal products) and share||
1619|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1619|108|I|the dosage of any medicines without your doctor's approval.||
1619|109|B|||
1619|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1619|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1619|112|O|poison control center right away. US residents can call||
1619|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1619|114|B|||
1619|115|N|NOTES:  Keep all medical and lab appointments.||
1619|116|B|||
1619|117|D|MISSED DOSE:  It is important to get each dose of this medication||
1619|118|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1619|119|D|right away for a new dosing schedule. Do not double the dose to||
1619|120|D|catch up.||
1619|121|B|||
1619|122|R|STORAGE:  Before mixing, store the vial at room temperature away||
1619|123|R|from light and moisture. Once mixed, consult the product||
1619|124|R|instructions and your pharmacist for storage details. Keep all||
1619|125|R|medications away from children and pets.||
1619|126|R|   Do not flush medications down the toilet or pour them into a||
1619|127|R|drain unless instructed to do so. Properly discard this product||
1619|128|R|when it is expired or no longer needed. Consult your pharmacist||
1619|129|R|or local waste disposal company.||
1619|130|B|||
1619|131|A|Information last revised December 2024.||
1619|132|A|Copyright(c) 2025 First Databank, Inc.||
1619|133|B|||
1620|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1620|002|Z|does NOT have all possible information about this product. This||
1620|003|Z|information does not assure that this product is safe, effective,||
1620|004|Z|or appropriate for you. This information is not individual||
1620|005|Z|medical advice and does not substitute for the advice of your||
1620|006|Z|health care professional. Always ask your health care||
1620|007|Z|professional for complete information about this product and your||
1620|008|Z|specific health needs.||
1620|009|B|||
1620|010|T|EFINACONAZOLE - TOPICAL||
1620|011|F|(EF-in-a-KON-a-zole)||
1620|012|B|||
1620|013|C|COMMON BRAND NAME(S): Jublia||
1620|014|B|||
1620|015|U|USES:  This medication is used to treat toenail infection caused||
1620|016|U|by fungus. It works by stopping the growth of certain types of||
1620|017|U|fungus. Efinaconazole belongs to a class of drugs known as azole||
1620|018|U|antifungals.||
1620|019|U|   This medication treats only fungal infections. It will not||
1620|020|U|work for other types of infection, such as those caused by||
1620|021|U|bacteria. Unnecessary use or overuse of any drug used to treat||
1620|022|U|infection can lead to its decreased effectiveness.||
1620|023|B|||
1620|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
1620|025|H|Instructions for Use if available from your pharmacist before you||
1620|026|H|start using efinaconazole and each time you get a refill. If you||
1620|027|H|have any questions, ask your doctor or pharmacist.||
1620|028|H|   Before applying this medication, clean and dry the infected||
1620|029|H|toenail(s). Wait at least 10 minutes after showering, bathing, or||
1620|030|H|washing before applying. Use this medication only on the infected||
1620|031|H|toenail(s) as directed by your doctor, usually once daily for 48||
1620|032|H|weeks. If this medication is used on a child, an adult should||
1620|033|H|apply it for them.||
1620|034|H|   Using the provided brush, apply to the infected toenail(s). Be||
1620|035|H|sure to completely cover the toenail, toenail folds, toenail bed,||
1620|036|H|and under the edges of the toenail. Wash your hands after using||
1620|037|H|it.||
1620|038|H|   Avoid getting this medication on any other part of your body.||
1620|039|H|If this accidentally happens, wipe off the medication and rinse||
1620|040|H|thoroughly with water.||
1620|041|H|   Use this medication regularly to get the most benefit from it.||
1620|042|H|To help you remember, use it at the same time each day. Continue||
1620|043|H|to use this medication for the full time prescribed, even if||
1620|044|H|symptoms disappear after a few days. Nail fungus treatment||
1620|045|H|usually must be continued a long time so that healthy nails can||
1620|046|H|grow and replace the infected toenail(s). Stopping the medication||
1620|047|H|too early may result in a return of the infection.||
1620|048|H|   Tell your doctor if your condition does not get better or if||
1620|049|H|it gets worse.||
1620|050|H|   This medication is flammable until dry. Avoid smoking or being||
1620|051|H|near open flames while using the medication and until the||
1620|052|H|medication has dried.||
1620|053|B|||
1620|054|S|SIDE EFFECTS:  Irritation or pain at the application site,||
1620|055|S|blisters, or ingrown toenail may occur. If any of these effects||
1620|056|S|last or get worse, stop using this medication and tell your||
1620|057|S|doctor or pharmacist promptly.||
1620|058|S|   Remember that this medication has been prescribed because your||
1620|059|S|doctor has judged that the benefit to you is greater than the||
1620|060|S|risk of side effects. Many people using this medication do not||
1620|061|S|have serious side effects.||
1620|062|S|   A very serious allergic reaction to this drug is rare.||
1620|063|S|However, get medical help right away if you notice any symptoms||
1620|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1620|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1620|066|S|breathing.||
1620|067|S|   This is not a complete list of possible side effects. If you||
1620|068|S|notice other effects not listed above, contact your doctor or||
1620|069|S|pharmacist.||
1620|070|S|   In the US -||
1620|071|S|   Call your doctor for medical advice about side effects. You||
1620|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1620|073|S|www.fda.gov/medwatch.||
1620|074|S|   In Canada - Call your doctor for medical advice about side||
1620|075|S|effects. You may report side effects to Health Canada at||
1620|076|S|1-866-234-2345.||
1620|077|B|||
1620|078|P|PRECAUTIONS:  Before using efinaconazole, tell your doctor or||
1620|079|P|pharmacist if you are allergic to it; or to other azole||
1620|080|P|antifungals (such as clotrimazole, fluconazole, ketoconazole); or||
1620|081|P|if you have any other allergies. This product may contain||
1620|082|P|inactive ingredients, which can cause allergic reactions or other||
1620|083|P|problems. Talk to your pharmacist for more details.||
1620|084|P|   Before using this medication, tell your doctor or pharmacist||
1620|085|P|your medical history.||
1620|086|P|   Before having surgery, tell your doctor or dentist about all||
1620|087|P|the products you use (including prescription drugs,||
1620|088|P|nonprescription drugs, and herbal products).||
1620|089|P|   During pregnancy, this medication should be used only when||
1620|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
1620|091|P|   It is unknown if this drug passes into breast milk. Consult||
1620|092|P|your doctor before breastfeeding.||
1620|093|B|||
1620|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1620|095|I|medications work or increase your risk for serious side effects.||
1620|096|I|This document does not contain all possible drug interactions.||
1620|097|I|Keep a list of all the products you use (including||
1620|098|I|prescription/nonprescription drugs and herbal products) and share||
1620|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
1620|100|I|the dosage of any medicines without your doctor's approval.||
1620|101|B|||
1620|102|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1620|103|O|has overdosed and has serious symptoms such as passing out or||
1620|104|O|trouble breathing, call 911. Otherwise, call a poison control||
1620|105|O|center right away. US residents can call 1-800-222-1222. Canada||
1620|106|O|residents can call 1-844-764-7669.||
1620|107|B|||
1620|108|N|NOTES:  Do not share this medication with others.||
1620|109|N|   This medication has been prescribed for your current condition||
1620|110|N|only. Do not use it later for another condition unless your||
1620|111|N|doctor directs you to do so. A different medication may be||
1620|112|N|necessary in that case.||
1620|113|B|||
1620|114|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1620|115|D|If it is near the time of the next dose, skip the missed dose.||
1620|116|D|Use your next dose at the regular time. Do not apply more of this||
1620|117|D|medication to try to catch up.||
1620|118|B|||
1620|119|R|STORAGE:  Store upright at room temperature. Do not freeze. This||
1620|120|R|product is flammable. Keep it away from heat and open flame. Keep||
1620|121|R|all medications away from children and pets.||
1620|122|R|   Do not flush medications down the toilet or pour them into a||
1620|123|R|drain unless instructed to do so. Properly discard this product||
1620|124|R|when it is expired or no longer needed. Consult your pharmacist||
1620|125|R|or local waste disposal company.||
1620|126|B|||
1620|127|A|Information last revised July 2025.||
1620|128|A|Copyright(c) 2025 First Databank, Inc.||
1620|129|B|||
1621|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1621|002|Z|does NOT have all possible information about this product. This||
1621|003|Z|information does not assure that this product is safe, effective,||
1621|004|Z|or appropriate for you. This information is not individual||
1621|005|Z|medical advice and does not substitute for the advice of your||
1621|006|Z|health care professional. Always ask your health care||
1621|007|Z|professional for complete information about this product and your||
1621|008|Z|specific health needs.||
1621|009|B|||
1621|010|T|RALTEGRAVIR POWDER PACKET - ORAL||
1621|011|F|(ral-TEG-ra-vir)||
1621|012|B|||
1621|013|C|COMMON BRAND NAME(S): Isentress||
1621|014|B|||
1621|015|U|USES:  This formulation of raltegravir is used with other HIV||
1621|016|U|medications for infants and children to help control HIV||
1621|017|U|infection. It helps to decrease the amount of HIV in the body so||
1621|018|U|your child's immune system can work better. This lowers the||
1621|019|U|chance of getting HIV complications (such as new infections,||
1621|020|U|cancer) and improves your child's quality of life. Raltegravir||
1621|021|U|belongs to a class of drugs known as integrase inhibitors. It||
1621|022|U|blocks the virus from growing and infecting more cells.||
1621|023|U|   Raltegravir is not a cure for HIV infection. To decrease the||
1621|024|U|risk of spreading HIV disease to others, your child should||
1621|025|U|continue to take all HIV medications exactly as prescribed by the||
1621|026|U|doctor. Do not share your child's personal items (such as||
1621|027|U|needles/syringes, toothbrushes) that may have contacted blood or||
1621|028|U|other body fluids. Consult the doctor or pharmacist for more||
1621|029|U|details.||
1621|030|B|||
1621|031|V|OTHER USES:  This section contains uses of this drug that are not||
1621|032|V|listed in the approved professional labeling for the drug but||
1621|033|V|that may be prescribed by your health care professional. Use this||
1621|034|V|drug for a condition that is listed in this section only if it||
1621|035|V|has been so prescribed by your health care professional.||
1621|036|V|   This product may also be used to lessen the risk of HIV||
1621|037|V|infection after contact with the virus (for example, due to a||
1621|038|V|needle stick). Ask your doctor for more details.||
1621|039|B|||
1621|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1621|041|H|from your pharmacist before you start giving raltegravir to your||
1621|042|H|child and each time you get a refill. If you have any questions,||
1621|043|H|ask the doctor or pharmacist.||
1621|044|H|   Give this medication to your child by mouth with or without||
1621|045|H|food as directed by the doctor, usually once or twice daily. The||
1621|046|H|dosage is based on your child's medical condition, response to||
1621|047|H|treatment, age, weight, and other medications your child may be||
1621|048|H|taking. Be sure to tell the doctor and pharmacist about all the||
1621|049|H|products your child uses (including prescription drugs,||
1621|050|H|nonprescription drugs, and herbal products).||
1621|051|H|   Empty the contents of one packet in the mixing cup. Measure||
1621|052|H|the amount of water as directed using the syringe and add it to||
1621|053|H|the mixing cup. Mix well by gently swirling the cup. Do not||
1621|054|H|shake. Measure the dose using the syringe. Do not use a household||
1621|055|H|spoon because you may not get the correct dose. Give the dose||
1621|056|H|within 30 minutes after mixing. Discard any portion you do not||
1621|057|H|use.||
1621|058|H|   Avoid using antacids that contain aluminum or magnesium while||
1621|059|H|taking this medication. These antacids can make raltegravir work||
1621|060|H|less well.||
1621|061|H|   It is very important to continue giving this medication (and||
1621|062|H|other HIV medications) exactly as prescribed by the doctor. Do||
1621|063|H|not skip any doses.||
1621|064|H|   Do not increase the dose or give this drug more often or for||
1621|065|H|longer than prescribed. Your child's condition will not improve||
1621|066|H|any faster, and the risk of side effects will increase.||
1621|067|H|   Do not give more or less of this drug than prescribed or stop||
1621|068|H|giving it (or other HIV medicines) even for a short time unless||
1621|069|H|directed to do so by the doctor. Doing so may cause the amount of||
1621|070|H|virus to increase, make the infection more difficult to treat||
1621|071|H|(resistant), or worsen side effects.||
1621|072|H|   For the best effect, take this medication at evenly spaced||
1621|073|H|times. To help you remember, take this medication at the same||
1621|074|H|time(s) every day.||
1621|075|H|   Do not switch between the film-coated tablet, the chewable||
1621|076|H|tablet, or the powder packet for oral suspension forms of||
1621|077|H|raltegravir without asking your doctor or pharmacist first.||
1621|078|B|||
1621|079|S|SIDE EFFECTS:  Headache, nausea, or trouble sleeping may occur.||
1621|080|S|If any of these effects last or get worse, tell the doctor or||
1621|081|S|pharmacist promptly.||
1621|082|S|   Remember that this medication has been prescribed because the||
1621|083|S|doctor has judged that the benefit to your child is greater than||
1621|084|S|the risk of side effects. Many people using this medication do||
1621|085|S|not have serious side effects.||
1621|086|S|   As your child's immune system gets stronger, it can begin to||
1621|087|S|fight off infections they already had, possibly causing disease||
1621|088|S|symptoms to come back. Your child could also have symptoms if||
1621|089|S|their immune system becomes overactive. This reaction may happen||
1621|090|S|at any time (soon after starting HIV treatment or many months||
1621|091|S|later). Tell your doctor right away if your child has any serious||
1621|092|S|symptoms, including: unexplained weight loss, severe tiredness,||
1621|093|S|muscle aches/weakness that doesn't go away, headaches that are||
1621|094|S|severe or don't go away, joint pain, numbness/tingling of the||
1621|095|S|hands/feet/arms/legs, vision changes, signs of infection (such as||
1621|096|S|sore throat the doesn't go away, fever, chills, swollen lymph||
1621|097|S|nodes, non-healing skin sores), signs of an overactive thyroid||
1621|098|S|(such as irritability, nervousness, heat intolerance,||
1621|099|S|fast/pounding/irregular heartbeat).||
1621|100|S|   Tell the doctor right away if your child has any serious side||
1621|101|S|effects, including: nausea/vomiting that doesn't stop, signs of||
1621|102|S|kidney problems (such as change in the amount of urine), loss of||
1621|103|S|appetite, severe stomach/abdominal pain, dark urine, yellowing||
1621|104|S|eyes/skin.||
1621|105|S|   Changes in body fat may occur while your child is taking this||
1621|106|S|medication (such as increased fat in the upper back and stomach||
1621|107|S|areas, decreased fat in the arms and legs). The cause and||
1621|108|S|long-term effects of these changes are unknown. Discuss the risks||
1621|109|S|and benefits of treatment with the doctor, as well as the||
1621|110|S|possible use of exercise to reduce this side effect.||
1621|111|S|   A very serious allergic reaction to this drug is rare.||
1621|112|S|However, get medical help right away if you notice any symptoms||
1621|113|S|of a serious allergic reaction, including: rash, itching/swelling||
1621|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1621|115|S|breathing.||
1621|116|S|   This is not a complete list of possible side effects. If you||
1621|117|S|notice other effects not listed above, contact the doctor or||
1621|118|S|pharmacist.||
1621|119|S|   In the US -||
1621|120|S|   Call your doctor for medical advice about side effects. You||
1621|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1621|122|S|www.fda.gov/medwatch.||
1621|123|S|   In Canada - Call your doctor for medical advice about side||
1621|124|S|effects. You may report side effects to Health Canada at||
1621|125|S|1-866-234-2345.||
1621|126|B|||
1621|127|P|PRECAUTIONS:  Before taking raltegravir, tell the doctor or||
1621|128|P|pharmacist if your child is allergic to it; or if your child has||
1621|129|P|any other allergies. This product may contain inactive||
1621|130|P|ingredients, which can cause allergic reactions or other||
1621|131|P|problems. Talk to your pharmacist for more details.||
1621|132|P|   Before using this medication, tell the doctor or pharmacist||
1621|133|P|your child's medical history, especially of: liver disease (such||
1621|134|P|as hepatitis B, hepatitis C), muscle disorders (such as||
1621|135|P|rhabdomyolysis, myopathy), high blood levels of creatine kinase||
1621|136|P|(high CK test results).||
1621|137|P|   Before having surgery, tell the doctor or dentist about all||
1621|138|P|the products your child uses (including prescription drugs,||
1621|139|P|nonprescription drugs, and herbal products).||
1621|140|P|   This formulation of raltegravir is not usually used by adults.||
1621|141|P|It is unlikely to be used during pregnancy or breastfeeding.||
1621|142|P|Consult the doctor if you have any questions about this||
1621|143|P|medication.||
1621|144|B|||
1621|145|I|DRUG INTERACTIONS:  See also How to Use section.||
1621|146|I|   Drug interactions may change how medications work or increase||
1621|147|I|the risk for serious side effects. This document does not contain||
1621|148|I|all possible drug interactions. Keep a list of all the products||
1621|149|I|your child uses (including prescription/nonprescription drugs and||
1621|150|I|herbal products) and share it with the doctor and pharmacist. Do||
1621|151|I|not start, stop, or change the dosage of any medicines without||
1621|152|I|the doctor's approval.||
1621|153|I|   A product that may interact with this drug is: orlistat.||
1621|154|I|   If you are breastfeeding your child, ask the doctor if any||
1621|155|I|medications that you are using may pass into the breast milk and||
1621|156|I|interact with this medication.||
1621|157|B|||
1621|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1621|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1621|160|O|poison control center right away. US residents can call||
1621|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1621|162|B|||
1621|163|N|NOTES:  Do not share this medication with others.||
1621|164|N|   Lab and/or medical tests (such as viral load, T-cell counts)||
1621|165|N|should be done while your child is taking this medication. Keep||
1621|166|N|all medical and lab appointments. Consult your doctor for more||
1621|167|N|details.||
1621|168|B|||
1621|169|D|MISSED DOSE:  If you miss a dose, give it as soon as you||
1621|170|D|remember. If it is near the time of the next dose, skip the||
1621|171|D|missed dose. Give the next dose at the regular time. Do not||
1621|172|D|double the dose to catch up.||
1621|173|B|||
1621|174|R|STORAGE:  Store in the original container at room temperature||
1621|175|R|away from light and moisture. Do not open foil packet until you||
1621|176|R|are ready to use the medication. Do not store in the bathroom.||
1621|177|R|Keep all medications away from children and pets.||
1621|178|R|   Do not flush medications down the toilet or pour them into a||
1621|179|R|drain unless instructed to do so. Properly discard this product||
1621|180|R|when it is expired or no longer needed. Consult your pharmacist||
1621|181|R|or local waste disposal company.||
1621|182|B|||
1621|183|A|Information last revised April 2025.||
1621|184|A|Copyright(c) 2025 First Databank, Inc.||
1621|185|B|||
1622|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1622|002|Z|does NOT have all possible information about this product. This||
1622|003|Z|information does not assure that this product is safe, effective,||
1622|004|Z|or appropriate for you. This information is not individual||
1622|005|Z|medical advice and does not substitute for the advice of your||
1622|006|Z|health care professional. Always ask your health care||
1622|007|Z|professional for complete information about this product and your||
1622|008|Z|specific health needs.||
1622|009|B|||
1622|010|T|TEDIZOLID - ORAL||
1622|011|F|(te-DIZ-oh-lid)||
1622|012|B|||
1622|013|C|COMMON BRAND NAME(S): Sivextro||
1622|014|B|||
1622|015|U|USES:  This medication is used to treat serious bacterial||
1622|016|U|infections of the skin. It works by stopping the growth of||
1622|017|U|bacteria.||
1622|018|U|   This antibiotic treats only bacterial infections. It will not||
1622|019|U|work for viral infections (such as common cold, flu). Using any||
1622|020|U|antibiotic when it is not needed can cause it to not work for||
1622|021|U|future infections.||
1622|022|B|||
1622|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1622|024|H|from your pharmacist before you start taking tedizolid and each||
1622|025|H|time you get a refill. If you have any questions, ask your doctor||
1622|026|H|or pharmacist.||
1622|027|H|   Take this medication by mouth with or without food as directed||
1622|028|H|by your doctor, usually once daily.||
1622|029|H|   For the best effect, take this antibiotic at evenly spaced||
1622|030|H|times. To help you remember, take this medication at the same||
1622|031|H|time(s) every day.||
1622|032|H|   Continue to take this medication until the full prescribed||
1622|033|H|amount is finished, even if symptoms disappear after a few days.||
1622|034|H|Stopping the medication too early may result in a return of the||
1622|035|H|infection.||
1622|036|H|   Tell your doctor if your condition lasts or gets worse.||
1622|037|B|||
1622|038|S|SIDE EFFECTS:  Nausea, headache, and diarrhea may occur. If any||
1622|039|S|of these effects last or get worse, tell your doctor or||
1622|040|S|pharmacist promptly.||
1622|041|S|   Remember that this medication has been prescribed because your||
1622|042|S|doctor has judged that the benefit to you is greater than the||
1622|043|S|risk of side effects. Many people using this medication do not||
1622|044|S|have serious side effects.||
1622|045|S|   Tell your doctor right away if you have any serious side||
1622|046|S|effects, including: sore throat that doesn't go away,||
1622|047|S|fast/pounding heartbeat, tingling/numbness of hands/feet, vision||
1622|048|S|changes (including loss of vision), easy bruising/bleeding,||
1622|049|S|unusual tiredness.||
1622|050|S|   This medication may rarely cause a severe intestinal condition||
1622|051|S|due to a bacteria called C. difficile. This condition may occur||
1622|052|S|during treatment or weeks to months after treatment has stopped.||
1622|053|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1622|054|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1622|055|S|stool.||
1622|056|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1622|057|S|products because they may make symptoms worse.||
1622|058|S|   Use of this medication for prolonged or repeated periods may||
1622|059|S|result in oral thrush or a new yeast infection. Contact your||
1622|060|S|doctor if you notice white patches in your mouth, a change in||
1622|061|S|vaginal discharge, or other new symptoms.||
1622|062|S|   A very serious allergic reaction to this drug is rare.||
1622|063|S|However, get medical help right away if you notice any symptoms||
1622|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1622|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1622|066|S|breathing.||
1622|067|S|   This is not a complete list of possible side effects. If you||
1622|068|S|notice other effects not listed above, contact your doctor or||
1622|069|S|pharmacist.||
1622|070|S|   In the US -||
1622|071|S|   Call your doctor for medical advice about side effects. You||
1622|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1622|073|S|www.fda.gov/medwatch.||
1622|074|S|   In Canada - Call your doctor for medical advice about side||
1622|075|S|effects. You may report side effects to Health Canada at||
1622|076|S|1-866-234-2345.||
1622|077|B|||
1622|078|P|PRECAUTIONS:  Before taking tedizolid, tell your doctor or||
1622|079|P|pharmacist if you are allergic to it; or if you have any other||
1622|080|P|allergies. This product may contain inactive ingredients, which||
1622|081|P|can cause allergic reactions or other problems. Talk to your||
1622|082|P|pharmacist for more details.||
1622|083|P|   Before using this medication, tell your doctor or pharmacist||
1622|084|P|your medical history, especially of: low white blood cell count.||
1622|085|P|   Tedizolid may cause live bacterial vaccines (such as typhoid||
1622|086|P|vaccine) to not work well. Tell your health care professional||
1622|087|P|that you are using tedizolid before having any||
1622|088|P|immunizations/vaccinations.||
1622|089|P|   Before having surgery, tell your doctor or dentist about all||
1622|090|P|the products you use (including prescription drugs,||
1622|091|P|nonprescription drugs, and herbal products).||
1622|092|P|   During pregnancy, this medication should be used only when||
1622|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
1622|094|P|   It is unknown if this drug passes into breast milk. Consult||
1622|095|P|your doctor before breastfeeding.||
1622|096|B|||
1622|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1622|098|I|medications work or increase your risk for serious side effects.||
1622|099|I|This document does not contain all possible drug interactions.||
1622|100|I|Keep a list of all the products you use (including||
1622|101|I|prescription/nonprescription drugs and herbal products) and share||
1622|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
1622|103|I|the dosage of any medicines without your doctor's approval.||
1622|104|B|||
1622|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1622|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1622|107|O|poison control center right away. US residents can call||
1622|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1622|109|B|||
1622|110|N|NOTES:  Do not share this medication with others.||
1622|111|N|   This medication has been prescribed for your current condition||
1622|112|N|only. Do not use it later for another infection unless your||
1622|113|N|doctor tells you to.||
1622|114|B|||
1622|115|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1622|116|D|remember. If it is less than 8 hours before the next dose, skip||
1622|117|D|the missed dose. Take your next dose at the regular time. Do not||
1622|118|D|double the dose to catch up.||
1622|119|B|||
1622|120|R|STORAGE:  Store at room temperature away from light and moisture.||
1622|121|R|Do not store in the bathroom. Keep all medications away from||
1622|122|R|children and pets.||
1622|123|R|   Do not flush medications down the toilet or pour them into a||
1622|124|R|drain unless instructed to do so. Properly discard this product||
1622|125|R|when it is expired or no longer needed. Consult your pharmacist||
1622|126|R|or local waste disposal company.||
1622|127|B|||
1622|128|A|Information last revised May 2024.||
1622|129|A|Copyright(c) 2025 First Databank, Inc.||
1622|130|B|||
1623|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1623|002|Z|does NOT have all possible information about this product. This||
1623|003|Z|information does not assure that this product is safe, effective,||
1623|004|Z|or appropriate for you. This information is not individual||
1623|005|Z|medical advice and does not substitute for the advice of your||
1623|006|Z|health care professional. Always ask your health care||
1623|007|Z|professional for complete information about this product and your||
1623|008|Z|specific health needs.||
1623|009|B|||
1623|010|T|TEDIZOLID - INJECTION||
1623|011|F|(te-DIZ-oh-lid)||
1623|012|B|||
1623|013|C|COMMON BRAND NAME(S): Sivextro||
1623|014|B|||
1623|015|U|USES:  This medication is used to treat serious bacterial||
1623|016|U|infections of the skin. It works by stopping the growth of||
1623|017|U|bacteria.||
1623|018|B|||
1623|019|H|HOW TO USE:  This medication is given by injection into a vein as||
1623|020|H|directed by your doctor, usually once or twice daily. This||
1623|021|H|medication should be injected slowly over 1 hour. Children's||
1623|022|H|dosage is based on weight.||
1623|023|H|   If you are using this medication at home, learn all||
1623|024|H|preparation and usage instructions from your health care||
1623|025|H|professional and the product package. Before using, check this||
1623|026|H|product for particles or discoloration. If either is present, do||
1623|027|H|not use the liquid. Learn how to store and discard medical||
1623|028|H|supplies safely.||
1623|029|H|   Antibiotics work best when the amount of medicine in your body||
1623|030|H|is kept at a constant level. Use this drug at evenly spaced||
1623|031|H|intervals.||
1623|032|H|   Continue to take this medication until the full prescribed||
1623|033|H|amount is finished, even if symptoms disappear after a few days.||
1623|034|H|Stopping the medication too early may result in a return of the||
1623|035|H|infection.||
1623|036|H|   Tell your doctor if your condition lasts or gets worse.||
1623|037|B|||
1623|038|S|SIDE EFFECTS:  Nausea, headache, diarrhea, and||
1623|039|S|pain/redness/swelling at injection site may occur. If any of||
1623|040|S|these effects last or get worse, tell your doctor or pharmacist||
1623|041|S|promptly.||
1623|042|S|   Remember that this medication has been prescribed because your||
1623|043|S|doctor has judged that the benefit to you is greater than the||
1623|044|S|risk of side effects. Many people using this medication do not||
1623|045|S|have serious side effects.||
1623|046|S|   Tell your doctor right away if you have any serious side||
1623|047|S|effects, including: sore throat that doesn't go away,||
1623|048|S|fast/pounding heartbeat, tingling/numbness of hands/feet, vision||
1623|049|S|changes (including loss of vision), easy bruising/bleeding,||
1623|050|S|unusual tiredness.||
1623|051|S|   This medication may rarely cause a severe intestinal condition||
1623|052|S|due to a bacteria called C. difficile. This condition may occur||
1623|053|S|during treatment or weeks to months after treatment has stopped.||
1623|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1623|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1623|056|S|stool.||
1623|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1623|058|S|products because they may make symptoms worse.||
1623|059|S|   Use of this medication for prolonged or repeated periods may||
1623|060|S|result in oral thrush or a new yeast infection. Contact your||
1623|061|S|doctor if you notice white patches in your mouth, a change in||
1623|062|S|vaginal discharge, or other new symptoms.||
1623|063|S|   A very serious allergic reaction to this drug is rare.||
1623|064|S|However, get medical help right away if you notice any symptoms||
1623|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1623|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1623|067|S|breathing.||
1623|068|S|   This is not a complete list of possible side effects. If you||
1623|069|S|notice other effects not listed above, contact your doctor or||
1623|070|S|pharmacist.||
1623|071|S|   In the US -||
1623|072|S|   Call your doctor for medical advice about side effects. You||
1623|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1623|074|S|www.fda.gov/medwatch.||
1623|075|S|   In Canada - Call your doctor for medical advice about side||
1623|076|S|effects. You may report side effects to Health Canada at||
1623|077|S|1-866-234-2345.||
1623|078|B|||
1623|079|P|PRECAUTIONS:  Before taking tedizolid, tell your doctor or||
1623|080|P|pharmacist if you are allergic to it; or if you have any other||
1623|081|P|allergies. This product may contain inactive ingredients, which||
1623|082|P|can cause allergic reactions or other problems. Talk to your||
1623|083|P|pharmacist for more details.||
1623|084|P|   Before using this medication, tell your doctor or pharmacist||
1623|085|P|your medical history, especially of: low white blood cell count.||
1623|086|P|   Tedizolid may cause live bacterial vaccines (such as typhoid||
1623|087|P|vaccine) not to work well. Tell your health care professional||
1623|088|P|that you are using tedizolid before having any||
1623|089|P|immunizations/vaccinations.||
1623|090|P|   Before having surgery, tell your doctor or dentist about all||
1623|091|P|the products you use (including prescription drugs,||
1623|092|P|nonprescription drugs, and herbal products).||
1623|093|P|   During pregnancy, this medication should be used only when||
1623|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
1623|095|P|   It is unknown if this drug passes into breast milk. Consult||
1623|096|P|your doctor before breastfeeding.||
1623|097|B|||
1623|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1623|099|I|medications work or increase your risk for serious side effects.||
1623|100|I|This document does not contain all possible drug interactions.||
1623|101|I|Keep a list of all the products you use (including||
1623|102|I|prescription/nonprescription drugs and herbal products) and share||
1623|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
1623|104|I|the dosage of any medicines without your doctor's approval.||
1623|105|B|||
1623|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1623|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1623|108|O|poison control center right away. US residents can call||
1623|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1623|110|B|||
1623|111|N|NOTES:  Keep all medical and lab appointments.||
1623|112|B|||
1623|113|D|MISSED DOSE:  It is important to get each dose of this medication||
1623|114|D|as scheduled. If you miss a dose, use it as soon as you remember.||
1623|115|D|If it is less than 8 hours before the next dose, skip the missed||
1623|116|D|dose. Use your next dose at the regular time. Do not double the||
1623|117|D|dose to catch up.||
1623|118|B|||
1623|119|R|STORAGE:  Before you mix it, store the vial of tedizolid at room||
1623|120|R|temperature away from light and moisture. Once it has been mixed,||
1623|121|R|consult the product instructions and your pharmacist for storage||
1623|122|R|details. Keep all medications away from children and pets.||
1623|123|R|   Do not flush medications down the toilet or pour them into a||
1623|124|R|drain unless instructed to do so. Properly discard this product||
1623|125|R|when it is expired or no longer needed. Consult your pharmacist||
1623|126|R|or local waste disposal company.||
1623|127|B|||
1623|128|A|Information last revised April 2025.||
1623|129|A|Copyright(c) 2025 First Databank, Inc.||
1623|130|B|||
1624|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1624|002|Z|does NOT have all possible information about this product. This||
1624|003|Z|information does not assure that this product is safe, effective,||
1624|004|Z|or appropriate for you. This information is not individual||
1624|005|Z|medical advice and does not substitute for the advice of your||
1624|006|Z|health care professional. Always ask your health care||
1624|007|Z|professional for complete information about this product and your||
1624|008|Z|specific health needs.||
1624|009|B|||
1624|010|T|TOPIRAMATE EXTENDED-RELEASE SPRINKLE - ORAL||
1624|011|F|(toe-PYRE-a-mate)||
1624|012|B|||
1624|013|C|COMMON BRAND NAME(S): Qudexy XR||
1624|014|B|||
1624|015|U|USES:  Topiramate is used alone and with other medications to||
1624|016|U|prevent and control seizures (epilepsy). It is also used to||
1624|017|U|prevent migraine headaches. Topiramate belongs to a class of||
1624|018|U|drugs known as anticonvulsants.||
1624|019|B|||
1624|020|V|OTHER USES:  This section contains uses of this drug that are not||
1624|021|V|listed in the approved professional labeling for the drug but||
1624|022|V|that may be prescribed by your health care professional. Use this||
1624|023|V|drug for a condition that is listed in this section only if it||
1624|024|V|has been so prescribed by your health care professional.||
1624|025|V|   This drug may also be used for binge eating disorder (BED).||
1624|026|B|||
1624|027|H|HOW TO USE:  Read the Medication Guide provided by your||
1624|028|H|pharmacist before you start taking topiramate and each time you||
1624|029|H|get a refill. If you have any questions, ask your doctor or||
1624|030|H|pharmacist.||
1624|031|H|   Take this medication by mouth with or without food as directed||
1624|032|H|by your doctor, usually once daily. You may swallow this||
1624|033|H|medication whole, or you may open the capsule and sprinkle the||
1624|034|H|contents on a teaspoonful of soft food (such as applesauce,||
1624|035|H|yogurt). Swallow the drug/food mixture right away. Do not crush||
1624|036|H|or chew the mixture. Do not prepare the mixture ahead of time for||
1624|037|H|later use. Drink some liquid after swallowing the mixture to make||
1624|038|H|sure all of the drug is swallowed.||
1624|039|H|   To prevent kidney stones from forming, drink plenty of fluids||
1624|040|H|while taking this medication unless otherwise directed by your||
1624|041|H|doctor.||
1624|042|H|   The dosage is based on your medical condition and response to||
1624|043|H|treatment. Children's dosage is also based on weight. To reduce||
1624|044|H|your risk of side effects, your doctor may direct you to start||
1624|045|H|this medication at a low dose and gradually increase your dose.||
1624|046|H|Follow your doctor's instructions carefully.||
1624|047|H|   Take this medication regularly to get the most benefit from||
1624|048|H|it. To help you remember, take it at the same time each day. Do||
1624|049|H|not stop taking this medication without consulting your doctor.||
1624|050|H|Some conditions may become worse when this drug is suddenly||
1624|051|H|stopped. Your dose may need to be gradually decreased.||
1624|052|H|   Tell your doctor if your condition does not get better or if||
1624|053|H|it gets worse.||
1624|054|B|||
1624|055|S|SIDE EFFECTS:  Tiredness, drowsiness, dizziness, loss of||
1624|056|S|coordination, nervousness, tingling of the hands/feet, loss of||
1624|057|S|appetite, changes in how foods taste, diarrhea, or weight loss||
1624|058|S|may occur. If any of these effects last or get worse, tell your||
1624|059|S|doctor or pharmacist promptly.||
1624|060|S|   Remember that this medication has been prescribed because your||
1624|061|S|doctor has judged that the benefit to you is greater than the||
1624|062|S|risk of side effects. Many people using this medication do not||
1624|063|S|have serious side effects.||
1624|064|S|   Tell your doctor right away if you have any serious side||
1624|065|S|effects, including: bone pain, signs of kidney stones (such as||
1624|066|S|severe back/side/abdominal/groin pain, fever, chills,||
1624|067|S|painful/frequent urination, bloody/pink urine), unusual||
1624|068|S|bleeding/bruising, confusion, difficulty concentrating, memory||
1624|069|S|loss, difficulty speaking.||
1624|070|S|   Get medical help right away if you have any very serious side||
1624|071|S|effects, including: rapid breathing, fast/slow/irregular||
1624|072|S|heartbeat.||
1624|073|S|   A small number of people who take anticonvulsants for any||
1624|074|S|condition (such as seizures, bipolar disorder, pain) may||
1624|075|S|experience depression, suicidal thoughts/attempts, or other||
1624|076|S|mental/mood problems. Tell your doctor right away if you or your||
1624|077|S|family/caregiver notice any unusual/sudden changes in your mood,||
1624|078|S|thoughts, or behavior including signs of depression, suicidal||
1624|079|S|thoughts/attempts, thoughts about harming yourself.||
1624|080|S|   Rarely, topiramate may cause a very serious eye problem,||
1624|081|S|usually within 1 month of starting treatment. This eye problem||
1624|082|S|can lead to permanent blindness. Get medical help right away if||
1624|083|S|any of these side effects occur: sudden vision changes (such as||
1624|084|S|decreased vision, blurred vision), eye pain/redness.||
1624|085|S|   This medication can rarely cause a serious metabolic problem||
1624|086|S|(high amount of ammonia in the blood), especially if you are also||
1624|087|S|taking valproic acid. Tell your doctor right away if you||
1624|088|S|experience sudden/unexplained tiredness, vomiting, or mental||
1624|089|S|changes (such as decreased alertness).||
1624|090|S|   A very serious allergic reaction to this drug is rare.||
1624|091|S|However, get medical help right away if you notice any symptoms||
1624|092|S|of a serious allergic reaction, including: rash, itching/swelling||
1624|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1624|094|S|breathing.||
1624|095|S|   This is not a complete list of possible side effects. If you||
1624|096|S|notice other effects not listed above, contact your doctor or||
1624|097|S|pharmacist.||
1624|098|S|   In the US -||
1624|099|S|   Call your doctor for medical advice about side effects. You||
1624|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1624|101|S|www.fda.gov/medwatch.||
1624|102|S|   In Canada - Call your doctor for medical advice about side||
1624|103|S|effects. You may report side effects to Health Canada at||
1624|104|S|1-866-234-2345.||
1624|105|B|||
1624|106|P|PRECAUTIONS:  Before taking topiramate, tell your doctor or||
1624|107|P|pharmacist if you are allergic to it; or if you have any other||
1624|108|P|allergies. This product may contain inactive ingredients, which||
1624|109|P|can cause allergic reactions or other problems. Talk to your||
1624|110|P|pharmacist for more details.||
1624|111|P|   Before using this medication, tell your doctor or pharmacist||
1624|112|P|your medical history, especially of: glaucoma, kidney problems||
1624|113|P|(such as kidney stones), liver problems, lung/breathing problems,||
1624|114|P|mental/mood problems (such as depression, thoughts of suicide), a||
1624|115|P|certain metabolic imbalance (metabolic acidosis), a diet high in||
1624|116|P|fat and low in carbohydrates (ketogenic diet), weak/brittle bones||
1624|117|P|(osteoporosis).||
1624|118|P|   This drug may make you dizzy or drowsy or affect your||
1624|119|P|thinking/coordination. Alcohol or marijuana (cannabis) can worsen||
1624|120|P|these effects. Do not drive, use machinery, or do anything that||
1624|121|P|needs alertness until you can do it safely. Avoid alcoholic||
1624|122|P|beverages. Talk to your doctor if you are using marijuana||
1624|123|P|(cannabis).||
1624|124|P|   Topiramate may make you sweat less, making you more likely to||
1624|125|P|get heat stroke. Avoid doing things that may cause you to||
1624|126|P|overheat, such as hard work or exercise in hot weather, or using||
1624|127|P|hot tubs. When the weather is hot, drink a lot of fluids and||
1624|128|P|dress lightly. If you overheat, quickly look for a place to cool||
1624|129|P|down and rest. Get medical help right away if you have a fever||
1624|130|P|that does not go away, mental/mood changes, headache, or||
1624|131|P|dizziness.||
1624|132|P|   Before having surgery, tell your doctor or dentist about all||
1624|133|P|the products you use (including prescription drugs,||
1624|134|P|nonprescription drugs, and herbal products).||
1624|135|P|   Children may be more sensitive to the side effects of this||
1624|136|P|drug, especially weakened bones, slowed growth rate, and||
1624|137|P|decreased sweating. Consult your doctor or pharmacist for more||
1624|138|P|details.||
1624|139|P|   Older adults may be more sensitive to the side effects of this||
1624|140|P|drug, especially dizziness. Dizziness can increase the risk of||
1624|141|P|falling.||
1624|142|P|   During pregnancy, this medication should be used only when||
1624|143|P|clearly needed. It may harm an unborn baby. However, if you are||
1624|144|P|taking this drug to treat seizures, note that untreated seizures||
1624|145|P|are a serious condition that can harm both a pregnant woman and||
1624|146|P|her unborn baby, so do not stop taking this medication unless||
1624|147|P|directed by your doctor. Discuss the use of reliable forms of||
1624|148|P|birth control with your doctor (see also Drug Interactions||
1624|149|P|section). If you are planning pregnancy, become pregnant, or||
1624|150|P|think you may be pregnant, immediately talk to your doctor about||
1624|151|P|the benefits and risks of using this medication during pregnancy.||
1624|152|P|   This medication passes into breast milk and may have||
1624|153|P|undesirable effects on a nursing infant. Consult your doctor||
1624|154|P|before breastfeeding.||
1624|155|B|||
1624|156|I|DRUG INTERACTIONS:  See also Side Effects section.||
1624|157|I|   Drug interactions may change how your medications work or||
1624|158|I|increase your risk for serious side effects. This document does||
1624|159|I|not contain all possible drug interactions. Keep a list of all||
1624|160|I|the products you use (including prescription/nonprescription||
1624|161|I|drugs and herbal products) and share it with your doctor and||
1624|162|I|pharmacist. Do not start, stop, or change the dosage of any||
1624|163|I|medicines without your doctor's approval.||
1624|164|I|   A product that may interact with this drug is: orlistat.||
1624|165|I|   This medication may decrease the effectiveness of hormonal||
1624|166|I|birth control such as pills, patch, or ring. This could cause||
1624|167|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1624|168|I|use reliable backup birth control methods while using this||
1624|169|I|medication. Also tell your doctor if you have any new spotting or||
1624|170|I|breakthrough bleeding, because these may be signs that your birth||
1624|171|I|control is not working well.||
1624|172|I|   Tell your doctor or pharmacist if you are taking other||
1624|173|I|products that cause drowsiness including alcohol, marijuana||
1624|174|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1624|175|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
1624|176|I|zolpidem), muscle relaxants (such as carisoprodol,||
1624|177|I|cyclobenzaprine), and opioid pain relievers (such as codeine).||
1624|178|I|   Check the labels on all your medicines (such as allergy or||
1624|179|I|cough-and-cold products) because they may contain ingredients||
1624|180|I|that cause drowsiness. Ask your pharmacist about using those||
1624|181|I|products safely.||
1624|182|B|||
1624|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1624|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1624|185|O|poison control center right away. US residents can call||
1624|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1624|187|O|Symptoms of overdose may include: severe drowsiness, loss of||
1624|188|O|consciousness.||
1624|189|B|||
1624|190|N|NOTES:  Do not share this medication with others.||
1624|191|N|   Lab and/or medical tests (such as eye exams, bicarbonate blood||
1624|192|N|level) should be done while you are taking this medication. Keep||
1624|193|N|all medical and lab appointments.||
1624|194|B|||
1624|195|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1624|196|D|remember. If it is near the time of the next dose, skip the||
1624|197|D|missed dose. Take your next dose at the regular time. Do not||
1624|198|D|double the dose to catch up. If you have missed more than one||
1624|199|D|dose, ask your doctor or pharmacist for advice.||
1624|200|B|||
1624|201|R|STORAGE:  Store at room temperature away from light and moisture.||
1624|202|R|Do not store in the bathroom. Keep all medications away from||
1624|203|R|children and pets.||
1624|204|R|   Do not flush medications down the toilet or pour them into a||
1624|205|R|drain unless instructed to do so. Properly discard this product||
1624|206|R|when it is expired or no longer needed. Consult your pharmacist||
1624|207|R|or local waste disposal company.||
1624|208|B|||
1624|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
1624|210|M|medical emergency. For information about enrolling in MedicAlert,||
1624|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1624|212|B|||
1624|213|A|Information last revised July 2025.||
1624|214|A|Copyright(c) 2025 First Databank, Inc.||
1624|215|B|||
1625|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1625|002|Z|does NOT have all possible information about this product. This||
1625|003|Z|information does not assure that this product is safe, effective,||
1625|004|Z|or appropriate for you. This information is not individual||
1625|005|Z|medical advice and does not substitute for the advice of your||
1625|006|Z|health care professional. Always ask your health care||
1625|007|Z|professional for complete information about this product and your||
1625|008|Z|specific health needs.||
1625|009|B|||
1625|010|T|ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT-Fc - INJECTION||
1625|011|F|(AN-tye-HEE-moe-FIL-ik FAK-tor)||
1625|012|B|||
1625|013|C|COMMON BRAND NAME(S): Altuviiio, Eloctate||
1625|014|B|||
1625|015|U|USES:  This medication is used to control and prevent bleeding||
1625|016|U|that happens to people (usually males) with an inherited medical||
1625|017|U|condition, hemophilia A (low levels of factor VIII). It is also||
1625|018|U|given before surgery to prevent too much bleeding in people with||
1625|019|U|this condition. Factor VIII is a protein (clotting factor) that||
1625|020|U|is in normal blood, and helps form blood clots and stop bleeding||
1625|021|U|after an injury. People with low factor VIII levels may bleed||
1625|022|U|longer than normal after an injury/surgery and may have bleeding||
1625|023|U|inside the body (especially in the joints and muscles). This||
1625|024|U|medication contains man-made factor VIII (antihemophilic factor)||
1625|025|U|to temporarily replace factor VIII in the body, connected to an||
1625|026|U|antibody (immunoglobulin) that helps the man-made factor VIII||
1625|027|U|work longer. When used to control and prevent bleeding, this||
1625|028|U|medication may help relieve pain and long-term damage caused by||
1625|029|U|hemophilia A.||
1625|030|U|   This medication should not be used to treat von Willebrand||
1625|031|U|disease.||
1625|032|B|||
1625|033|H|HOW TO USE:  Read the Patient Information Leaflet and||
1625|034|H|Instructions for Use if available from your pharmacist before you||
1625|035|H|start using this medication and each time you get a refill. If||
1625|036|H|you have any questions, ask your doctor or pharmacist.||
1625|037|H|   This medication is given by injection into a vein as directed||
1625|038|H|by your doctor. The injection time may be different, depending on||
1625|039|H|your dose and how you respond to it.||
1625|040|H|   After first receiving this medication in a clinic or hospital,||
1625|041|H|some people may be able to give this medication to themselves at||
1625|042|H|home. If your doctor directs you to use this medication at home,||
1625|043|H|read the Instructions for Use and learn all preparation and usage||
1625|044|H|instructions from your health care professional. Learn how to||
1625|045|H|store and discard medical supplies safely. If you have any||
1625|046|H|questions, ask your health care professional.||
1625|047|H|   If the medication and the solution used to mix it are||
1625|048|H|refrigerated, take them out of the refrigerator ahead of time and||
1625|049|H|let them come to room temperature before mixing. After mixing,||
1625|050|H|gently swirl to completely dissolve the powder. Do not shake.||
1625|051|H|Before using, check this product for particles or discoloration.||
1625|052|H|If either is present, do not use the liquid. Use the mixed||
1625|053|H|medication as soon as possible, but no later than 3 hours after||
1625|054|H|mixing. Do not refrigerate the mixed medication.||
1625|055|H|   The dosage is based on your medical condition, weight, blood||
1625|056|H|test results, and response to treatment. Follow your doctor's||
1625|057|H|instructions carefully.||
1625|058|H|   Tell your doctor if your condition does not get better or if||
1625|059|H|it gets worse.||
1625|060|B|||
1625|061|S|SIDE EFFECTS:  Headache or joint pain may occur. If either of||
1625|062|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1625|063|S|promptly.||
1625|064|S|   Remember that this medication has been prescribed because your||
1625|065|S|doctor has judged that the benefit to you is greater than the||
1625|066|S|risk of side effects. Many people using this medication do not||
1625|067|S|have serious side effects.||
1625|068|S|   A very serious allergic reaction to this drug is rare.||
1625|069|S|However, get medical help right away if you notice any symptoms||
1625|070|S|of a serious allergic reaction, including: rash, itching/swelling||
1625|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1625|072|S|breathing, chest discomfort/tightness.||
1625|073|S|   This is not a complete list of possible side effects. If you||
1625|074|S|notice other effects not listed above, contact your doctor or||
1625|075|S|pharmacist.||
1625|076|S|   In the US -||
1625|077|S|   Call your doctor for medical advice about side effects. You||
1625|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1625|079|S|www.fda.gov/medwatch.||
1625|080|S|   In Canada - Call your doctor for medical advice about side||
1625|081|S|effects. You may report side effects to Health Canada at||
1625|082|S|1-866-234-2345.||
1625|083|B|||
1625|084|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1625|085|P|pharmacist if you are allergic to any antihemophilic factor||
1625|086|P|(factor VIII) products; or if you have any other allergies. This||
1625|087|P|product may contain inactive ingredients, which can cause||
1625|088|P|allergic reactions or other problems. Talk to your pharmacist for||
1625|089|P|more details.||
1625|090|P|   Before using this medication, tell your doctor or pharmacist||
1625|091|P|your medical history.||
1625|092|P|   Before having surgery, tell your doctor or dentist about all||
1625|093|P|the products you use (including prescription drugs,||
1625|094|P|nonprescription drugs, and herbal products).||
1625|095|P|   The manufacturers of some brands of this medication recommend||
1625|096|P|that you check your pulse while giving yourself the injection. If||
1625|097|P|your heart starts to beat faster, you may need to give this||
1625|098|P|medication more slowly or stop the infusion until your heart rate||
1625|099|P|returns to normal. Consult your doctor for more details.||
1625|100|P|   During pregnancy, this medication should be used only when||
1625|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
1625|102|P|   It is unknown if this medication passes into breast milk.||
1625|103|P|Consult your doctor before breastfeeding.||
1625|104|B|||
1625|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1625|106|I|medications work or increase your risk for serious side effects.||
1625|107|I|This document does not contain all possible drug interactions.||
1625|108|I|Keep a list of all the products you use (including||
1625|109|I|prescription/nonprescription drugs and herbal products) and share||
1625|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
1625|111|I|the dosage of any medicines without your doctor's approval.||
1625|112|B|||
1625|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1625|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1625|115|O|poison control center right away. US residents can call||
1625|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1625|117|B|||
1625|118|N|NOTES:  Do not share this medication with others.||
1625|119|N|   Lab blood tests (such as factor VIII levels, factor VIII||
1625|120|N|inhibitors) should be done while you are using this medication.||
1625|121|N|Keep all medical and lab appointments. Consult your doctor for||
1625|122|N|more details.||
1625|123|B|||
1625|124|D|MISSED DOSE:  It is important to get each dose of this medication||
1625|125|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1625|126|D|right away for a new dosing schedule. Do not double the dose to||
1625|127|D|catch up.||
1625|128|B|||
1625|129|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1625|130|R|medication in the original package to protect from light. This||
1625|131|R|medication may also be stored at room temperature if needed. If||
1625|132|R|the medication is stored at room temperature, do not put it back||
1625|133|R|in the refrigerator and discard after 6 months. After mixing, use||
1625|134|R|this medication within 3 hours. Discard any unused portion. Keep||
1625|135|R|all medications away from children and pets.||
1625|136|R|   Do not flush medications down the toilet or pour them into a||
1625|137|R|drain unless instructed to do so. Properly discard this product||
1625|138|R|when it is expired or no longer needed. Consult your pharmacist||
1625|139|R|or local waste disposal company.||
1625|140|B|||
1625|141|M|MEDICAL ALERT:  Your condition can cause complications in a||
1625|142|M|medical emergency. For information about enrolling in MedicAlert,||
1625|143|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1625|144|B|||
1625|145|A|Information last revised November 2024.||
1625|146|A|Copyright(c) 2025 First Databank, Inc.||
1625|147|B|||
1626|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1626|002|Z|does NOT have all possible information about this product. This||
1626|003|Z|information does not assure that this product is safe, effective,||
1626|004|Z|or appropriate for you. This information is not individual||
1626|005|Z|medical advice and does not substitute for the advice of your||
1626|006|Z|health care professional. Always ask your health care||
1626|007|Z|professional for complete information about this product and your||
1626|008|Z|specific health needs.||
1626|009|B|||
1626|010|T|BELINOSTAT - INJECTION||
1626|011|F|(be-LIN-oh-stat)||
1626|012|B|||
1626|013|C|COMMON BRAND NAME(S): Beleodaq||
1626|014|B|||
1626|015|U|USES:  Belinostat is used to treat a certain type of cancer||
1626|016|U|(peripheral T-cell lymphoma - PTCL). Belinostat works by slowing||
1626|017|U|or stopping the growth of cancer cells.||
1626|018|B|||
1626|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1626|020|H|from your pharmacist before you start using belinostat and each||
1626|021|H|time you get a refill. If you have any questions, ask your doctor||
1626|022|H|or pharmacist.||
1626|023|H|   This medication is given by a health care professional. It is||
1626|024|H|injected slowly into a vein over 30 minutes. It is given as||
1626|025|H|directed by your doctor, usually once a day on days 1 through 5||
1626|026|H|of a 21-day treatment cycle. The dosage is based on your medical||
1626|027|H|condition, body size, lab tests, response to treatment, and other||
1626|028|H|medications you may be taking. Be sure to tell your doctor and||
1626|029|H|pharmacist about all the products you use (including prescription||
1626|030|H|drugs, nonprescription drugs, and herbal products).||
1626|031|H|   Infusion reactions may happen during the infusion of this||
1626|032|H|drug. Tell your doctor right away if you have any symptoms of||
1626|033|H|infusion reactions such as redness, pain, or swelling at the||
1626|034|H|infusion site. Your doctor may slow down your infusion.||
1626|035|H|   To get the most benefit from this medication, do not miss any||
1626|036|H|doses. To help you remember, mark your calendar with a reminder.||
1626|037|B|||
1626|038|S|SIDE EFFECTS:  See also How to Use section.||
1626|039|S|   Tell your doctor if you have nausea, vomiting, or diarrhea.||
1626|040|S|Your doctor may prescribe medications to prevent or relieve these||
1626|041|S|symptoms. Eating several small meals, not eating before||
1626|042|S|treatment, or limiting activity may help lessen some of these||
1626|043|S|effects. Tiredness, headache, constipation, decreased appetite,||
1626|044|S|or dizziness may also occur. If any of these effects last or get||
1626|045|S|worse, tell your doctor or pharmacist promptly.||
1626|046|S|   People using this medication may have serious side effects.||
1626|047|S|However, you have been prescribed this drug because your doctor||
1626|048|S|has judged that the benefit to you is greater than the risk of||
1626|049|S|side effects. Careful monitoring by your doctor may decrease your||
1626|050|S|risk.||
1626|051|S|   Tell your doctor right away if you have any serious side||
1626|052|S|effects, including: easy bleeding/bruising, swelling||
1626|053|S|hands/ankles/feet, symptoms of anemia (such as severe tiredness,||
1626|054|S|pale skin, shortness of breath).||
1626|055|S|   This medication may lower your ability to fight infections.||
1626|056|S|This may make you more likely to get a serious (rarely fatal)||
1626|057|S|infection or make any infection you have worse. Tell your doctor||
1626|058|S|right away if you have any signs of infection (such as sore||
1626|059|S|throat that doesn't go away, fever, chills).||
1626|060|S|   Belinostat may rarely cause serious (possibly fatal) liver||
1626|061|S|disease. Get medical help right away if you have any symptoms of||
1626|062|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1626|063|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1626|064|S|urine.||
1626|065|S|   Belinostat sometimes causes side effects due to the rapid||
1626|066|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1626|067|S|risk, your doctor may add a medication and tell you to drink||
1626|068|S|plenty of fluids. Tell your doctor right away if you have||
1626|069|S|symptoms such as: low back/side pain (flank pain), signs of||
1626|070|S|kidney problems (such as painful urination, pink/bloody urine,||
1626|071|S|change in the amount of urine), muscle spasms/weakness.||
1626|072|S|   A very serious allergic reaction to this drug is rare.||
1626|073|S|However, get medical help right away if you notice any symptoms||
1626|074|S|of a serious allergic reaction, including: rash, itching/swelling||
1626|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1626|076|S|breathing.||
1626|077|S|   This is not a complete list of possible side effects. If you||
1626|078|S|notice other effects not listed above, contact your doctor or||
1626|079|S|pharmacist.||
1626|080|S|   In the US -||
1626|081|S|   Call your doctor for medical advice about side effects. You||
1626|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1626|083|S|www.fda.gov/medwatch.||
1626|084|S|   In Canada - Call your doctor for medical advice about side||
1626|085|S|effects. You may report side effects to Health Canada at||
1626|086|S|1-866-234-2345.||
1626|087|B|||
1626|088|P|PRECAUTIONS:  Before using belinostat, tell your doctor or||
1626|089|P|pharmacist if you are allergic to it; or if you have any other||
1626|090|P|allergies. This product may contain inactive ingredients, which||
1626|091|P|can cause allergic reactions or other problems. Talk to your||
1626|092|P|pharmacist for more details.||
1626|093|P|   Before using this medication, tell your doctor or pharmacist||
1626|094|P|your medical history, especially of: current/recent/past||
1626|095|P|infections (such as flu, tuberculosis), kidney disease, liver||
1626|096|P|problems.||
1626|097|P|   Belinostat can make you more likely to get infections or may||
1626|098|P|make current infections worse. Stay away from anyone who has an||
1626|099|P|infection that may easily spread (such as chickenpox, COVID-19,||
1626|100|P|measles, flu). Talk to your doctor if you have been exposed to an||
1626|101|P|infection or for more details.||
1626|102|P|   Tell your health care professional that you are using||
1626|103|P|belinostat before having any immunizations/vaccinations. Avoid||
1626|104|P|contact with people who have recently received live vaccines||
1626|105|P|(such as flu vaccine inhaled through the nose).||
1626|106|P|   To lower the chance of getting cut, bruised, or injured, use||
1626|107|P|caution with sharp objects like razors and nail cutters, and||
1626|108|P|avoid activities such as contact sports.||
1626|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1626|110|P|can make you more dizzy. Do not drive, use machinery, or do||
1626|111|P|anything that needs alertness until you can do it safely. Limit||
1626|112|P|alcoholic beverages. Talk to your doctor if you are using||
1626|113|P|marijuana (cannabis).||
1626|114|P|   Before having surgery, tell your doctor or dentist about all||
1626|115|P|the products you use (including prescription drugs,||
1626|116|P|nonprescription drugs, and herbal products).||
1626|117|P|   Tell your doctor if you are pregnant or plan to become||
1626|118|P|pregnant. You should not become pregnant while using belinostat.||
1626|119|P|Belinostat may harm an unborn baby. Your doctor should order a||
1626|120|P|pregnancy test before you start this medication. Women using this||
1626|121|P|medication should ask about reliable forms of birth control||
1626|122|P|during treatment and for 6 months after the last dose. Men using||
1626|123|P|this medication should ask about reliable forms of birth control||
1626|124|P|during treatment and for 3 months after the last dose. If you or||
1626|125|P|your partner becomes pregnant, talk to your doctor right away||
1626|126|P|about the risks and benefits of this medication.||
1626|127|P|   It is unknown if this drug passes into breast milk.||
1626|128|P|Breastfeeding is not recommended while using this drug and for 2||
1626|129|P|weeks after the last dose. Consult your doctor before||
1626|130|P|breastfeeding.||
1626|131|B|||
1626|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1626|133|I|medications work or increase your risk for serious side effects.||
1626|134|I|This document does not contain all possible drug interactions.||
1626|135|I|Keep a list of all the products you use (including||
1626|136|I|prescription/nonprescription drugs and herbal products) and share||
1626|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
1626|138|I|the dosage of any medicines without your doctor's approval.||
1626|139|B|||
1626|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1626|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1626|142|O|poison control center right away. US residents can call||
1626|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1626|144|B|||
1626|145|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
1626|146|N|kidney/liver function) should be done before you start using this||
1626|147|N|medication and while you are using it. Keep all medical and lab||
1626|148|N|appointments. Consult your doctor for more details.||
1626|149|B|||
1626|150|D|MISSED DOSE:  It is important to get each dose of this medication||
1626|151|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1626|152|D|right away for a new dosing schedule.||
1626|153|B|||
1626|154|R|STORAGE:  Not applicable. This medication is given in a hospital||
1626|155|R|or clinic and will not be stored at home.||
1626|156|B|||
1626|157|M|MEDICAL ALERT:  Your condition can cause complications in a||
1626|158|M|medical emergency. For information about enrolling in MedicAlert,||
1626|159|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1626|160|B|||
1626|161|A|Information last revised April 2025.||
1626|162|A|Copyright(c) 2025 First Databank, Inc.||
1626|163|B|||
1627|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1627|002|Z|does NOT have all possible information about this product. This||
1627|003|Z|information does not assure that this product is safe, effective,||
1627|004|Z|or appropriate for you. This information is not individual||
1627|005|Z|medical advice and does not substitute for the advice of your||
1627|006|Z|health care professional. Always ask your health care||
1627|007|Z|professional for complete information about this product and your||
1627|008|Z|specific health needs.||
1627|009|B|||
1627|010|T|IDELALISIB - ORAL||
1627|011|F|(eye-DEL-a-LIS-ib)||
1627|012|B|||
1627|013|C|COMMON BRAND NAME(S): Zydelig||
1627|014|B|||
1627|015|W|WARNING:  Idelalisib may cause serious (possibly fatal) liver||
1627|016|W|disease. Your doctor will test your liver function while you are||
1627|017|W|taking this medication. Tell your doctor right away if you have||
1627|018|W|any symptoms of liver damage, including nausea/vomiting that||
1627|019|W|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
1627|020|W|eyes/skin, dark urine.||
1627|021|W|   This medication can cause severe diarrhea and a tear in the||
1627|022|W|stomach/intestines (gastrointestinal perforation). Tell your||
1627|023|W|doctor right away if you develop diarrhea that doesn't stop,||
1627|024|W|abdominal or stomach pain/cramping, blood/mucus in your stool,||
1627|025|W|fever, nausea/vomiting, or dizziness/fainting.||
1627|026|W|   Idelalisib can cause severe (possibly fatal) lung problems||
1627|027|W|(pneumonitis). Tell your doctor right away if you have any||
1627|028|W|symptoms of lung problems (such as worsening cough, shortness of||
1627|029|W|breath, trouble breathing, wheezing).||
1627|030|W|   This medication may lower your ability to fight infections.||
1627|031|W|This may make you more likely to get a serious (rarely fatal)||
1627|032|W|infection or make any infection you have worse. Your doctor may||
1627|033|W|prescribe an antibiotic to help prevent serious infection during||
1627|034|W|and after treatment with this medication. Carefully follow your||
1627|035|W|doctor's instructions. Get medical help right away if you have||
1627|036|W|any signs of infection (such as sore throat that doesn't go away,||
1627|037|W|fever, chills, new or worsening lymph node swelling).||
1627|038|B|||
1627|039|U|USES:  This medication is used to treat a certain type of cancer||
1627|040|U|(chronic lymphocytic leukemia-CLL). Idelalisib belongs to a class||
1627|041|U|of drugs known as kinase inhibitors. It works by slowing or||
1627|042|U|stopping the growth of cancer cells.||
1627|043|B|||
1627|044|H|HOW TO USE:  See also Warning section.||
1627|045|H|   Read the Medication Guide provided by your pharmacist before||
1627|046|H|you start taking idelalisib and each time you get a refill. If||
1627|047|H|you have any questions, ask your doctor or pharmacist.||
1627|048|H|   Take this medication by mouth with or without food as directed||
1627|049|H|by your doctor, usually twice daily. Swallow the tablets whole.||
1627|050|H|Do not chew or crush the tablets.||
1627|051|H|   The dosage is based on your medical condition and response to||
1627|052|H|treatment. Do not increase your dose or use this drug more often||
1627|053|H|or for longer than prescribed. Your condition will not improve||
1627|054|H|any faster, and your risk of side effects will increase.||
1627|055|H|   Since this drug can be absorbed through the skin and lungs and||
1627|056|H|may harm an unborn baby, women who are pregnant or who may become||
1627|057|H|pregnant should not handle this medication or breathe the dust||
1627|058|H|from the tablets.||
1627|059|B|||
1627|060|S|SIDE EFFECTS:  See also Warning section.||
1627|061|S|   Diarrhea, headache, heartburn, mouth/throat sores, and trouble||
1627|062|S|sleeping may occur. If any of these effects last or get worse,||
1627|063|S|tell your doctor or pharmacist promptly.||
1627|064|S|   People using this medication may have serious side effects.||
1627|065|S|However, you have been prescribed this drug because your doctor||
1627|066|S|has judged that the benefit to you is greater than the risk of||
1627|067|S|side effects. Careful monitoring by your doctor may decrease your||
1627|068|S|risk.||
1627|069|S|   Tell your doctor right away if you have any serious side||
1627|070|S|effects, including: easy bruising/bleeding, swelling||
1627|071|S|hands/ankles/feet, sudden vision changes.||
1627|072|S|   Idelalisib can commonly cause a rash that is usually not||
1627|073|S|serious. However, you may not be able to tell it apart from a||
1627|074|S|rare rash that could be a sign of a severe reaction. Get medical||
1627|075|S|help right away if you develop any rash.||
1627|076|S|   This medication can weaken the immune system/increase the risk||
1627|077|S|of infection, including a rare but very serious (possibly fatal)||
1627|078|S|brain infection (progressive multifocal leukoencephalopathy-PML).||
1627|079|S|Get medical help right away if you have any of these side||
1627|080|S|effects: clumsiness, loss of coordination/balance, weakness,||
1627|081|S|sudden change in your thinking (such as confusion, difficulty||
1627|082|S|concentrating, memory loss), difficulty talking/walking, seizure.||
1627|083|S|   A very serious allergic reaction to this drug is rare.||
1627|084|S|However, get medical help right away if you notice any symptoms||
1627|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1627|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1627|087|S|breathing.||
1627|088|S|   This is not a complete list of possible side effects. If you||
1627|089|S|notice other effects not listed above, contact your doctor or||
1627|090|S|pharmacist.||
1627|091|S|   In the US -||
1627|092|S|   Call your doctor for medical advice about side effects. You||
1627|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1627|094|S|www.fda.gov/medwatch.||
1627|095|S|   In Canada - Call your doctor for medical advice about side||
1627|096|S|effects. You may report side effects to Health Canada at||
1627|097|S|1-866-234-2345.||
1627|098|B|||
1627|099|P|PRECAUTIONS:  Before taking idelalisib, tell your doctor or||
1627|100|P|pharmacist if you are allergic to it; or if you have any other||
1627|101|P|allergies. This product may contain inactive ingredients, which||
1627|102|P|can cause allergic reactions or other problems. Talk to your||
1627|103|P|pharmacist for more details.||
1627|104|P|   Before using this medication, tell your doctor or pharmacist||
1627|105|P|your medical history, especially of: liver disease, lung||
1627|106|P|problems, stomach/intestinal ulcers, current serious infection.||
1627|107|P|   Idelalisib can make you more likely to get infections or may||
1627|108|P|make current infections worse. Stay away from anyone who has an||
1627|109|P|infection that may easily spread (such as chickenpox, COVID-19,||
1627|110|P|measles, flu). Talk to your doctor if you have been exposed to an||
1627|111|P|infection or for more details.||
1627|112|P|   Tell your health care professional that you are using||
1627|113|P|idelalisib before having any immunizations/vaccinations. Avoid||
1627|114|P|contact with people who have recently received live vaccines||
1627|115|P|(such as flu vaccine inhaled through the nose).||
1627|116|P|   To lower the chance of getting cut, bruised, or injured, use||
1627|117|P|caution with sharp objects like razors and nail cutters, and||
1627|118|P|avoid activities such as contact sports.||
1627|119|P|   Before having surgery, tell your doctor or dentist about all||
1627|120|P|the products you use (including prescription drugs,||
1627|121|P|nonprescription drugs, and herbal products).||
1627|122|P|   Older adults may be more sensitive to the side effects of this||
1627|123|P|drug.||
1627|124|P|   Tell your doctor if you are pregnant or plan to become||
1627|125|P|pregnant. You should not become pregnant while using idelalisib.||
1627|126|P|Idelalisib may harm an unborn baby. Women using this medication||
1627|127|P|should ask about reliable forms of birth control during treatment||
1627|128|P|and for 1 month after the last dose. Men using this medication||
1627|129|P|should ask about reliable forms of birth control during treatment||
1627|130|P|and for 3 months after the last dose. If you or your partner||
1627|131|P|becomes pregnant, talk to your doctor right away about the risks||
1627|132|P|and benefits of this medication.||
1627|133|P|   Since this drug can be absorbed through the skin and lungs and||
1627|134|P|may harm an unborn baby, women who are pregnant or who may become||
1627|135|P|pregnant should not handle this medication or breathe the dust||
1627|136|P|from the tablets.||
1627|137|P|   It is unknown if this drug passes into breast milk. Because of||
1627|138|P|the possible risk to the infant, breastfeeding is not recommended||
1627|139|P|while using this drug and for 1 month after the last dose.||
1627|140|P|Consult your doctor before breastfeeding.||
1627|141|B|||
1627|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1627|143|I|medications work or increase your risk for serious side effects.||
1627|144|I|This document does not contain all possible drug interactions.||
1627|145|I|Keep a list of all the products you use (including||
1627|146|I|prescription/nonprescription drugs and herbal products) and share||
1627|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
1627|148|I|the dosage of any medicines without your doctor's approval.||
1627|149|I|   Some products that may interact with this drug are:||
1627|150|I|bendamustine, other drugs that weaken the immune system/increase||
1627|151|I|the risk of infection (such as natalizumab, rituximab).||
1627|152|I|   Other medications can affect the removal of idelalisib from||
1627|153|I|your body, which may affect how idelalisib works. Examples||
1627|154|I|include rifampin, phenytoin, carbamazepine, St. John's wort,||
1627|155|I|among others.||
1627|156|I|   This medication can slow down the removal of other medications||
1627|157|I|from your body, which may affect how they work. Examples of||
1627|158|I|affected drugs include daridorexant, domperidone, elacestrant,||
1627|159|I|finerenone, flibanserin, ivabradine, lurasidone, mavacamten,||
1627|160|I|midazolam, pacritinib, sparsentan, triazolam, among others.||
1627|161|B|||
1627|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1627|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1627|164|O|poison control center right away. US residents can call||
1627|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1627|166|B|||
1627|167|N|NOTES:  Do not share this medication with others.||
1627|168|N|   Lab and/or medical tests (such as liver function, complete||
1627|169|N|blood count) should be done before you start taking this||
1627|170|N|medication and while you are taking it. Keep all medical and lab||
1627|171|N|appointments. Consult your doctor for more details.||
1627|172|B|||
1627|173|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1627|174|D|remember. If it is more than 6 hours after the missed dose, skip||
1627|175|D|the missed dose. Take your next dose at the regular time. Do not||
1627|176|D|double the dose to catch up.||
1627|177|B|||
1627|178|R|STORAGE:  Store in the original container at room temperature||
1627|179|R|away from light and moisture. Do not store in the bathroom. Keep||
1627|180|R|all medications away from children and pets.||
1627|181|R|   Do not flush medications down the toilet or pour them into a||
1627|182|R|drain unless instructed to do so. Properly discard this product||
1627|183|R|when it is expired or no longer needed. Consult your pharmacist||
1627|184|R|or local waste disposal company.||
1627|185|B|||
1627|186|M|MEDICAL ALERT:  Your condition can cause complications in a||
1627|187|M|medical emergency. For information about enrolling in MedicAlert,||
1627|188|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1627|189|B|||
1627|190|A|Information last revised April 2025.||
1627|191|A|Copyright(c) 2025 First Databank, Inc.||
1627|192|B|||
1629|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1629|002|Z|does NOT have all possible information about this product. This||
1629|003|Z|information does not assure that this product is safe, effective,||
1629|004|Z|or appropriate for you. This information is not individual||
1629|005|Z|medical advice and does not substitute for the advice of your||
1629|006|Z|health care professional. Always ask your health care||
1629|007|Z|professional for complete information about this product and your||
1629|008|Z|specific health needs.||
1629|009|B|||
1629|010|T|NEOMYCIN/FLUOCINOLONE - TOPICAL||
1629|011|F|(NEE-oh-MYE-sin/FLOO-oh-SIN-oh-lone)||
1629|012|B|||
1629|013|C|COMMON BRAND NAME(S): Neo-synalar||
1629|014|B|||
1629|015|U|USES:  This medication is used to treat certain skin infections.||
1629|016|U|This product contains neomycin, an antibiotic that works by||
1629|017|U|stopping the growth of bacteria. It also contains fluocinolone, a||
1629|018|U|medium-strength corticosteroid that helps to reduce swelling,||
1629|019|U|itching, and redness of the skin.||
1629|020|U|   This medication treats only bacterial skin infections. It will||
1629|021|U|not work for other types of skin infections (such as infections||
1629|022|U|caused by fungi, viruses). Unnecessary use or misuse of any||
1629|023|U|antibiotic can lead to its decreased effectiveness.||
1629|024|B|||
1629|025|H|HOW TO USE:  This medication is for use on the skin only. Wash||
1629|026|H|your hands before using. Clean and dry the affected area. Apply a||
1629|027|H|thin film of medication to the affected area and gently rub in as||
1629|028|H|directed by your doctor, usually 2 to 4 times a day. Wash your||
1629|029|H|hands after use, unless you are using this product to treat the||
1629|030|H|hands.||
1629|031|H|   Do not cover, bandage, or wrap the area unless directed to do||
1629|032|H|so by your doctor.||
1629|033|H|   Do not use large amounts of this medication or apply this more||
1629|034|H|often or for a longer period than directed. Your condition will||
1629|035|H|not improve any faster, and your risk of side effects will||
1629|036|H|increase. This product is not recommended for use over a wide||
1629|037|H|area of the body. Do not use this product for longer than 1 week||
1629|038|H|unless directed by your doctor.||
1629|039|H|   Avoid getting this medication in your eyes or inside the mouth||
1629|040|H|or nose. If this occurs, wipe off the medication and rinse||
1629|041|H|thoroughly with water.||
1629|042|H|   Use this medication regularly to get the most benefit from it.||
1629|043|H|To help you remember, use it at the same times each day.||
1629|044|H|   Tell your doctor if your condition does not get better after 1||
1629|045|H|week.||
1629|046|B|||
1629|047|S|SIDE EFFECTS:  Burning, irritation, or dryness of the skin may||
1629|048|S|occur. If any of these effects last or get worse, tell your||
1629|049|S|doctor or pharmacist promptly.||
1629|050|S|   Remember that this medication has been prescribed because your||
1629|051|S|doctor has judged that the benefit to you is greater than the||
1629|052|S|risk of side effects. Many people using this medication do not||
1629|053|S|have serious side effects.||
1629|054|S|   Tell your doctor right away if you have any serious side||
1629|055|S|effects, including: stretch marks, skin thinning/discoloration,||
1629|056|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
1629|057|S|(folliculitis).||
1629|058|S|   Rarely, use of this medication for prolonged or repeated||
1629|059|S|periods may result in other types of skin infections (such as||
1629|060|S|fungal or other bacterial infections). Contact your doctor if you||
1629|061|S|notice any unusual skin symptoms or if your condition does not||
1629|062|S|improve.||
1629|063|S|   Rarely, it is possible this medication will be absorbed from||
1629|064|S|the skin into the bloodstream. This can lead to side effects of||
1629|065|S|too much corticosteroid. These side effects are more likely in||
1629|066|S|children, and in people who use this medication for a long time||
1629|067|S|or over large areas of the skin. Tell your doctor right away if||
1629|068|S|any of the following side effects occur: unusual/extreme||
1629|069|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
1629|070|S|thirst/urination, vision problems.||
1629|071|S|   A very serious allergic reaction to this drug is rare.||
1629|072|S|However, get medical help right away if you notice any symptoms||
1629|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1629|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1629|075|S|breathing.||
1629|076|S|   This is not a complete list of possible side effects. If you||
1629|077|S|notice other effects not listed above, contact your doctor or||
1629|078|S|pharmacist.||
1629|079|S|   In the US -||
1629|080|S|   Call your doctor for medical advice about side effects. You||
1629|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1629|082|S|www.fda.gov/medwatch.||
1629|083|S|   In Canada - Call your doctor for medical advice about side||
1629|084|S|effects. You may report side effects to Health Canada at||
1629|085|S|1-866-234-2345.||
1629|086|B|||
1629|087|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1629|088|P|pharmacist if you are allergic to neomycin or fluocinolone; or to||
1629|089|P|aminoglycoside antibiotics (such as gentamicin, tobramycin); or||
1629|090|P|if you have any other allergies. This product may contain||
1629|091|P|inactive ingredients, which can cause allergic reactions or other||
1629|092|P|problems. Talk to your pharmacist for more details.||
1629|093|P|   Before using this medication, tell your doctor or pharmacist||
1629|094|P|your medical history.||
1629|095|P|   This medication should not be used to treat an infection in||
1629|096|P|the outer ear canal if the eardrum is torn (perforated).||
1629|097|P|   Rarely, using corticosteroid medications for a long time or||
1629|098|P|over large areas of skin can make it more difficult for your body||
1629|099|P|to respond to physical stress. Before having surgery or emergency||
1629|100|P|treatment, or if you get a serious illness/injury, tell your||
1629|101|P|doctor or dentist that you are using this medication or have used||
1629|102|P|this medication within the past few months.||
1629|103|P|   Though it is unlikely, this medication may temporarily slow||
1629|104|P|down a child's growth if used for a long time. See the doctor||
1629|105|P|regularly so your child's height can be checked.||
1629|106|P|   During pregnancy, this medication should be used only when||
1629|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
1629|108|P|   It is unknown if this medication passes into breast milk.||
1629|109|P|Consult your doctor before breastfeeding.||
1629|110|B|||
1629|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1629|112|I|medications work or increase your risk for serious side effects.||
1629|113|I|This document does not contain all possible drug interactions.||
1629|114|I|Keep a list of all the products you use (including||
1629|115|I|prescription/nonprescription drugs and herbal products) and share||
1629|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1629|117|I|the dosage of any medicines without your doctor's approval.||
1629|118|B|||
1629|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1629|120|O|has overdosed and has serious symptoms such as passing out or||
1629|121|O|trouble breathing, call 911. Otherwise, call a poison control||
1629|122|O|center right away. US residents can call 1-800-222-1222. Canada||
1629|123|O|residents can call 1-844-764-7669.||
1629|124|B|||
1629|125|N|NOTES:  Do not share this medication with others.||
1629|126|N|   This medication has been prescribed for your current condition||
1629|127|N|only. Do not use it later for another infection unless your||
1629|128|N|doctor tells you to.||
1629|129|B|||
1629|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1629|131|D|If it is near the time of the next dose, skip the missed dose.||
1629|132|D|Use your next dose at the regular time. Do not double the dose to||
1629|133|D|catch up.||
1629|134|B|||
1629|135|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
1629|136|R|medications away from children and pets.||
1629|137|R|   Do not flush medications down the toilet or pour them into a||
1629|138|R|drain unless instructed to do so. Properly discard this product||
1629|139|R|when it is expired or no longer needed. Consult your pharmacist||
1629|140|R|or local waste disposal company.||
1629|141|B|||
1629|142|A|Information last revised November 2024.||
1629|143|A|Copyright(c) 2025 First Databank, Inc.||
1629|144|B|||
1630|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1630|002|Z|does NOT have all possible information about this product. This||
1630|003|Z|information does not assure that this product is safe, effective,||
1630|004|Z|or appropriate for you. This information is not individual||
1630|005|Z|medical advice and does not substitute for the advice of your||
1630|006|Z|health care professional. Always ask your health care||
1630|007|Z|professional for complete information about this product and your||
1630|008|Z|specific health needs.||
1630|009|B|||
1630|010|T|DAPAGLIFLOZIN/METFORMIN EXTENDED-RELEASE - ORAL||
1630|011|F|(DAP-a-gli-FLOE-zin/met-FOR-min)||
1630|012|B|||
1630|013|C|COMMON BRAND NAME(S): Xigduo XR||
1630|014|B|||
1630|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1630|016|W|cause a serious (sometimes fatal) condition called lactic||
1630|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1630|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1630|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1630|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1630|021|W|you are using certain drugs. For some conditions, your doctor may||
1630|022|W|tell you to stop taking this medication for a short time. Ask||
1630|023|W|your doctor or pharmacist for more details.||
1630|024|W|   Stop taking this medication and get medical help right away if||
1630|025|W|you have any symptoms of lactic acidosis, such as unusual||
1630|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1630|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1630|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1630|029|B|||
1630|030|U|USES:  This medication is a combination of 2 drugs: dapagliflozin||
1630|031|U|and metformin. It is used with a proper diet and exercise program||
1630|032|U|to control high blood sugar in people with type 2 diabetes.||
1630|033|U|Controlling high blood sugar helps prevent kidney damage,||
1630|034|U|blindness, nerve problems, loss of limbs, and sexual function||
1630|035|U|problems. Proper control of diabetes may also lessen your risk of||
1630|036|U|a heart attack or stroke. This medication is also used to treat||
1630|037|U|kidney disease or heart failure in people with type 2 diabetes.||
1630|038|U|It helps to lower the risk of death from heart disease and||
1630|039|U|reduces the need of going to a hospital to treat heart failure.||
1630|040|U|This medication works by helping to restore your body's proper||
1630|041|U|response to the insulin you naturally produce. It also increases||
1630|042|U|the removal of sugar by your kidneys, decreases how much sugar is||
1630|043|U|made in your liver, and decreases how much sugar your body takes||
1630|044|U|in through your stomach and intestines.||
1630|045|B|||
1630|046|H|HOW TO USE:  Read the Medication Guide provided by your||
1630|047|H|pharmacist before you start taking this medication and each time||
1630|048|H|you get a refill. If you have any questions, ask your doctor or||
1630|049|H|pharmacist.||
1630|050|H|   Take this medication by mouth as directed by your doctor,||
1630|051|H|usually once daily in the morning with food. Swallow the tablets||
1630|052|H|whole. Do not crush or chew the tablets. Doing so can release all||
1630|053|H|of the drug at once, increasing the risk of side effects.||
1630|054|H|   The dosage is based on your medical condition, response to||
1630|055|H|treatment, and other medications you may be taking. Be sure to||
1630|056|H|tell your doctor and pharmacist about all the products you use||
1630|057|H|(including prescription drugs, nonprescription drugs, and herbal||
1630|058|H|products). To reduce your risk of side effects (such as diarrhea,||
1630|059|H|nausea, and vomiting), your doctor may direct you to start this||
1630|060|H|medication at a low dose and gradually increase your dose. Follow||
1630|061|H|your doctor's instructions carefully.||
1630|062|H|   Take this medication regularly to get the most benefit from||
1630|063|H|it. To help you remember, take it at the same time each day.||
1630|064|H|   Tell your doctor if your condition does not get better or if||
1630|065|H|it gets worse (your blood sugar is too high or too low).||
1630|066|B|||
1630|067|S|SIDE EFFECTS:  See also Warning section.||
1630|068|S|   Headache, diarrhea, nausea, vomiting, runny nose, or sore||
1630|069|S|throat may occur. If any of these effects last or get worse, tell||
1630|070|S|your doctor or pharmacist promptly. If stomach symptoms return||
1630|071|S|later (after taking the same dose for several days or weeks),||
1630|072|S|tell your doctor right away. Stomach symptoms that occur after||
1630|073|S|the first days of your treatment may be signs of lactic acidosis.||
1630|074|S|   An empty tablet shell may appear in your stool. This effect is||
1630|075|S|harmless because your body has already absorbed the medication.||
1630|076|S|   Remember that this medication has been prescribed because your||
1630|077|S|doctor has judged that the benefit to you is greater than the||
1630|078|S|risk of side effects. Many people using this medication do not||
1630|079|S|have serious side effects.||
1630|080|S|   Tell your doctor right away if you have any serious side||
1630|081|S|effects, including: signs of a urinary tract infection (such as||
1630|082|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1630|083|S|signs of kidney problems (such as change in the amount of urine,||
1630|084|S|swelling legs/feet).||
1630|085|S|   This medication may cause a new yeast infection in the vagina||
1630|086|S|or the penis. It may also cause a rare but very serious bacterial||
1630|087|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1630|088|S|your doctor right away if you have signs of a yeast infection in||
1630|089|S|the vagina (such as unusual vaginal||
1630|090|S|discharge/burning/itching/odor) or in the penis (such as||
1630|091|S|redness/itching/swelling of the penis, unusual discharge from the||
1630|092|S|penis). However, get medical help right away if you have any||
1630|093|S|pain/redness/swelling in or around the genital/anal area, along||
1630|094|S|with a fever or feeling unwell.||
1630|095|S|   This medication does not usually cause low blood sugar||
1630|096|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1630|097|S|prescribed with other diabetes medications, or if you do not get||
1630|098|S|enough calories from food, or if you do unusually heavy exercise.||
1630|099|S|Talk with your doctor or pharmacist about whether the dose of||
1630|100|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1630|101|S|of low blood sugar include sudden sweating, shaking, fast||
1630|102|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1630|103|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1630|104|S|treat low blood sugar. If you don't have these reliable forms of||
1630|105|S|glucose, rapidly raise your blood sugar by eating a quick source||
1630|106|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1630|107|S|juice or non-diet soda. Tell your doctor right away about the||
1630|108|S|reaction and the use of this product. To help prevent low blood||
1630|109|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1630|110|S|Check with your doctor or pharmacist to find out what you should||
1630|111|S|do if you miss a meal.||
1630|112|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1630|113|S|thirst/urination. If these symptoms occur, tell your doctor right||
1630|114|S|away. Your doctor may need to adjust your diabetes medication,||
1630|115|S|exercise program, or diet.||
1630|116|S|   This medication may cause you to become dehydrated. This can||
1630|117|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1630|118|S|dehydration. Tell your doctor or pharmacist right away if you are||
1630|119|S|not able to drink fluids as usual, or losing fluid (such as due||
1630|120|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1630|121|S|right away if you have any signs of dehydration, such as||
1630|122|S|urinating less than usual, unusual dry mouth/thirst, fast||
1630|123|S|heartbeat, or dizziness/lightheadedness/fainting. To reduce the||
1630|124|S|risk of dizziness and lightheadedness, get up slowly when rising||
1630|125|S|from a sitting or lying position.||
1630|126|S|   A very serious allergic reaction to this drug is rare.||
1630|127|S|However, get medical help right away if you notice any symptoms||
1630|128|S|of a serious allergic reaction, including: rash, itching/swelling||
1630|129|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1630|130|S|breathing.||
1630|131|S|   This is not a complete list of possible side effects. If you||
1630|132|S|notice other effects not listed above, contact your doctor or||
1630|133|S|pharmacist.||
1630|134|S|   In the US -||
1630|135|S|   Call your doctor for medical advice about side effects. You||
1630|136|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1630|137|S|www.fda.gov/medwatch.||
1630|138|S|   In Canada - Call your doctor for medical advice about side||
1630|139|S|effects. You may report side effects to Health Canada at||
1630|140|S|1-866-234-2345.||
1630|141|B|||
1630|142|P|PRECAUTIONS:  See also Warning section.||
1630|143|P|   Before taking this medication, tell your doctor or pharmacist||
1630|144|P|if you are allergic to dapagliflozin or metformin; or if you have||
1630|145|P|any other allergies. This product may contain inactive||
1630|146|P|ingredients, which can cause allergic reactions or other||
1630|147|P|problems. Talk to your pharmacist for more details.||
1630|148|P|   Before using this medication, tell your doctor or pharmacist||
1630|149|P|your medical history, especially of: breathing problems (such as||
1630|150|P|asthma, obstructive lung disease), kidney disease, liver disease,||
1630|151|P|disease of the pancreas (pancreatitis), use/abuse of alcohol,||
1630|152|P|yeast infections in the vagina or penis, dehydration, blood||
1630|153|P|problems (such as anemia, vitamin B12 deficiency).||
1630|154|P|   You may experience blurred vision, dizziness, or drowsiness||
1630|155|P|due to extremely low or high blood sugar. Do not drive, use||
1630|156|P|machinery, or do anything that needs alertness or clear vision||
1630|157|P|until you can do it safely.||
1630|158|P|   Limit alcohol while taking this medication because it can||
1630|159|P|increase your risk of developing lactic acidosis, low blood||
1630|160|P|sugar, and a high ketone level.||
1630|161|P|   High fever, "water pills" (diuretics such as||
1630|162|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1630|163|P|may cause dehydration and increase your risk of lactic acidosis.||
1630|164|P|Stop taking this medication and tell your doctor right away if||
1630|165|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1630|166|P|fluids to prevent dehydration unless your doctor directs you||
1630|167|P|otherwise.||
1630|168|P|   It may be harder to control your blood sugar when your body is||
1630|169|P|stressed (such as due to fever, infection, injury, or surgery).||
1630|170|P|Also, if you are eating less or not able to eat due to these||
1630|171|P|conditions or any illness, this can lead to a high ketone level||
1630|172|P|while you are taking this medication. Consult your doctor because||
1630|173|P|this may require a change in your treatment plan, medications, or||
1630|174|P|blood sugar or ketone testing.||
1630|175|P|   Before having surgery or any X-ray/scanning procedure using||
1630|176|P|iodinated contrast, tell your doctor or dentist about all the||
1630|177|P|products you use (including prescription drugs, nonprescription||
1630|178|P|drugs, and herbal products). You may need to stop this medication||
1630|179|P|for a short time for the surgery/procedure. Ask your doctor or||
1630|180|P|dentist for instructions before your surgery/procedure.||
1630|181|P|   Older adults may be more sensitive to the side effects of this||
1630|182|P|drug, especially low blood sugar, dehydration, lactic acidosis,||
1630|183|P|kidney problems, and low blood pressure.||
1630|184|P|   During pregnancy, this medication should be used only when||
1630|185|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1630|186|P|benefits with your doctor.||
1630|187|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1630|188|P|your doctor for managing your blood sugar while pregnant. Your||
1630|189|P|doctor may change your diabetes treatment during your pregnancy||
1630|190|P|(such as diet and medications including insulin).||
1630|191|P|   Metformin can cause changes in the menstrual cycle (promote||
1630|192|P|ovulation) and increase the risk of becoming pregnant. Consult||
1630|193|P|your doctor or pharmacist about the use of reliable birth control||
1630|194|P|while using this medication.||
1630|195|P|   Metformin passes into breast milk in small amounts. It is||
1630|196|P|unknown if dapagliflozin passes into breast milk. Consult your||
1630|197|P|doctor before breastfeeding.||
1630|198|B|||
1630|199|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1630|200|I|medications work or increase your risk for serious side effects.||
1630|201|I|This document does not contain all possible drug interactions.||
1630|202|I|Keep a list of all the products you use (including||
1630|203|I|prescription/nonprescription drugs and herbal products) and share||
1630|204|I|it with your doctor and pharmacist. Do not start, stop, or change||
1630|205|I|the dosage of any medicines without your doctor's approval.||
1630|206|I|   Many drugs can affect your blood sugar, making it harder to||
1630|207|I|control. Before you start, stop, or change any medication, talk||
1630|208|I|with your doctor or pharmacist about how the medication may||
1630|209|I|affect your blood sugar. Check your blood sugar regularly as||
1630|210|I|directed and share the results with your doctor. Tell your doctor||
1630|211|I|right away if you have symptoms of high or low blood sugar. (See||
1630|212|I|also Side Effects section.) Your doctor may need to adjust your||
1630|213|I|diabetes medication, exercise program, or diet.||
1630|214|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1630|215|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1630|216|I|heartbeat you would usually feel when your blood sugar falls too||
1630|217|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1630|218|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1630|219|I|   This medication may interfere with certain lab tests (such as||
1630|220|I|urine glucose test), possibly causing false test results. Make||
1630|221|I|sure lab personnel and all your doctors know you use this drug.||
1630|222|B|||
1630|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1630|224|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1630|225|O|poison control center right away. US residents can call||
1630|226|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1630|227|O|Overdose can lead to lactic acidosis. Symptoms of overdose may||
1630|228|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
1630|229|O|rapid breathing, slow/irregular heartbeat.||
1630|230|B|||
1630|231|N|NOTES:  Do not share this medication with others.||
1630|232|N|   Attend a diabetes education program to learn more about how to||
1630|233|N|manage your diabetes with medications, diet, exercise, and||
1630|234|N|regular medical exams.||
1630|235|N|   Learn the symptoms of high and low blood sugar and how to||
1630|236|N|treat low blood sugar. Check your blood sugar regularly as||
1630|237|N|directed.||
1630|238|N|   Lab and/or medical tests (such as kidney function, liver||
1630|239|N|function, blood sugar, hemoglobin A1c, ketones, complete blood||
1630|240|N|counts, cholesterol, vitamin B12) should be done before you start||
1630|241|N|taking this medication and while you are taking it. Keep all||
1630|242|N|medical and lab appointments. Consult your doctor for more||
1630|243|N|details.||
1630|244|B|||
1630|245|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1630|246|D|remember. If it is near the time of the next dose, skip the||
1630|247|D|missed dose. Take your next dose at the regular time. Do not||
1630|248|D|double the dose to catch up.||
1630|249|B|||
1630|250|R|STORAGE:  Store at room temperature away from light and moisture.||
1630|251|R|Do not store in the bathroom. Keep all medications away from||
1630|252|R|children and pets.||
1630|253|R|   Do not flush medications down the toilet or pour them into a||
1630|254|R|drain unless instructed to do so. Properly discard this product||
1630|255|R|when it is expired or no longer needed. Consult your pharmacist||
1630|256|R|or local waste disposal company.||
1630|257|B|||
1630|258|M|MEDICAL ALERT:  Your condition can cause complications in a||
1630|259|M|medical emergency. For information about enrolling in MedicAlert,||
1630|260|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1630|261|B|||
1630|262|A|Information last revised May 2025.||
1630|263|A|Copyright(c) 2025 First Databank, Inc.||
1630|264|B|||
1631|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1631|002|Z|does NOT have all possible information about this product. This||
1631|003|Z|information does not assure that this product is safe, effective,||
1631|004|Z|or appropriate for you. This information is not individual||
1631|005|Z|medical advice and does not substitute for the advice of your||
1631|006|Z|health care professional. Always ask your health care||
1631|007|Z|professional for complete information about this product and your||
1631|008|Z|specific health needs.||
1631|009|B|||
1631|010|T|SUVOREXANT - ORAL||
1631|011|F|(SOO-voe-REX-ant)||
1631|012|B|||
1631|013|C|COMMON BRAND NAME(S): Belsomra||
1631|014|B|||
1631|015|U|USES:  This medication is used to treat a certain sleep problem||
1631|016|U|(insomnia). It may help you fall asleep and stay asleep longer,||
1631|017|U|so you can get a better night's rest. Suvorexant belongs to a||
1631|018|U|class of drugs known as sedative-hypnotics.||
1631|019|U|   If your insomnia continues for longer than 7 to 10 days after||
1631|020|U|starting treatment, talk to your doctor to see if you need other||
1631|021|U|treatment.||
1631|022|B|||
1631|023|H|HOW TO USE:  Read the Medication Guide provided by your||
1631|024|H|pharmacist before you start taking suvorexant and each time you||
1631|025|H|get a refill. If you have any questions, ask your doctor or||
1631|026|H|pharmacist.||
1631|027|H|   Take suvorexant by mouth as directed by your doctor, usually||
1631|028|H|30 minutes before you get into bed. This medication can be taken||
1631|029|H|with or without food, but it may take longer to work if you take||
1631|030|H|it with or right after a meal.||
1631|031|H|   The dosage is based on your medical condition, response to||
1631|032|H|treatment, and other medications you may be taking. Be sure to||
1631|033|H|tell your doctor and pharmacist about all the products you use||
1631|034|H|(including prescription drugs, nonprescription drugs, and herbal||
1631|035|H|products).||
1631|036|H|   Do not take a dose of this drug unless you have time for a||
1631|037|H|full night's sleep of at least 7 hours. If you have to wake up||
1631|038|H|before that, you may have some memory loss and may have trouble||
1631|039|H|safely doing anything that needs alertness, such as driving or||
1631|040|H|operating machinery. (See also Precautions section.)||
1631|041|H|   Do not increase your dose, take it more often, or use it for||
1631|042|H|longer than prescribed. Your condition will not improve any||
1631|043|H|faster, and your risk of side effects will increase.||
1631|044|H|   Do not take this medication with alcohol, or if you have had||
1631|045|H|alcohol that day, especially in the evening before bed. Also, do||
1631|046|H|not take this medication with other drugs to help you sleep.||
1631|047|H|   When this medication is used for a long time, it may not work||
1631|048|H|as well. Talk with your doctor if this medication stops working||
1631|049|H|well.||
1631|050|H|   Though it helps many people, this medication may sometimes||
1631|051|H|cause addiction. This risk may be higher if you have a substance||
1631|052|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1631|053|H|Take this medication exactly as prescribed to lower the risk of||
1631|054|H|addiction. Ask your doctor or pharmacist for more details.||
1631|055|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
1631|056|H|or if it gets worse.||
1631|057|B|||
1631|058|S|SIDE EFFECTS:  Unusual dreams may occur. If this effect lasts or||
1631|059|S|gets worse, tell your doctor or pharmacist promptly.||
1631|060|S|   Suvorexant may make you sleepy during the day. Tell your||
1631|061|S|doctor if you have daytime drowsiness. Your dose may need to be||
1631|062|S|adjusted.||
1631|063|S|   Remember that this medication has been prescribed because your||
1631|064|S|doctor has judged that the benefit to you is greater than the||
1631|065|S|risk of side effects. Many people using this medication do not||
1631|066|S|have serious side effects.||
1631|067|S|   Tell your doctor right away if you have any serious side||
1631|068|S|effects, including: mental/mood changes (such as depression,||
1631|069|S|thoughts of suicide), temporary weakness in your legs.||
1631|070|S|   This medication may cause sleep paralysis, which is a||
1631|071|S|temporary inability to move or talk (for up to several minutes)||
1631|072|S|while you are going to sleep or waking up.||
1631|073|S|   Rarely, after taking this drug, people have gotten out of bed||
1631|074|S|and driven vehicles while not fully awake ("sleep-driving").||
1631|075|S|People have also sleepwalked, prepared/eaten food, made phone||
1631|076|S|calls, or had sex while not fully awake. Often, these people do||
1631|077|S|not remember these events. This problem can be dangerous to you||
1631|078|S|or to others. If you find out that you have done any of these||
1631|079|S|activities after taking this medication, tell your doctor right||
1631|080|S|away. Your risk is increased if you use alcohol or other||
1631|081|S|medications that can make you drowsy while taking suvorexant.||
1631|082|S|   A very serious allergic reaction to this drug is rare.||
1631|083|S|However, get medical help right away if you notice any symptoms||
1631|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1631|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1631|086|S|breathing.||
1631|087|S|   This is not a complete list of possible side effects. If you||
1631|088|S|notice other effects not listed above, contact your doctor or||
1631|089|S|pharmacist.||
1631|090|S|   In the US -||
1631|091|S|   Call your doctor for medical advice about side effects. You||
1631|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1631|093|S|www.fda.gov/medwatch.||
1631|094|S|   In Canada - Call your doctor for medical advice about side||
1631|095|S|effects. You may report side effects to Health Canada at||
1631|096|S|1-866-234-2345.||
1631|097|B|||
1631|098|P|PRECAUTIONS:  Before taking suvorexant, tell your doctor or||
1631|099|P|pharmacist if you are allergic to it; or if you have any other||
1631|100|P|allergies. This product may contain inactive ingredients which||
1631|101|P|can cause allergic reactions or other problems. Talk to your||
1631|102|P|pharmacist for more details.||
1631|103|P|   Before using this medication, tell your doctor or pharmacist||
1631|104|P|your medical history, especially of: a certain sleep disorder||
1631|105|P|(narcolepsy), liver disease, lung disease/breathing problems||
1631|106|P|(such as sleep apnea, chronic obstructive pulmonary disease-||
1631|107|P|COPD), mental/mood problems (such as depression, thoughts of||
1631|108|P|suicide), personal or family history of a substance use disorder||
1631|109|P|(such as overuse of or addiction to drugs/alcohol), a certain||
1631|110|P|muscle weakness disorder (cataplexy).||
1631|111|P|   The effects of this drug can last even after you wake up the||
1631|112|P|next day. If you did not get at least 7 hours of sleep or took||
1631|113|P|other medications that made you sleepy or are more sensitive to||
1631|114|P|this drug, you may feel alert but not think clearly enough to||
1631|115|P|drive. Alcohol or marijuana (cannabis) can also make you more||
1631|116|P|sleepy. Wait at least 8 hours after taking this drug before||
1631|117|P|driving, and do not drive, use machinery, or do anything that||
1631|118|P|needs alertness until you can do it safely. Avoid alcoholic||
1631|119|P|beverages. Talk to your doctor if you are using marijuana||
1631|120|P|(cannabis). If you take the 20 milligram dosage of suvorexant, do||
1631|121|P|not drive, use machinery, or do anything that needs alertness the||
1631|122|P|next day.||
1631|123|P|   Before having surgery, tell your doctor or dentist about all||
1631|124|P|the products you use (including prescription drugs,||
1631|125|P|nonprescription drugs, and herbal products).||
1631|126|P|   Older adults may be more sensitive to the side effects of this||
1631|127|P|drug, especially confusion, unsteadiness, excessive drowsiness.||
1631|128|P|Unsteadiness and drowsiness may increase the risk of falls.||
1631|129|P|   During pregnancy, this medication should be used only when||
1631|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
1631|131|P|   This medication passes into breast milk. Consult your doctor||
1631|132|P|before breastfeeding.||
1631|133|B|||
1631|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1631|135|I|medications work or increase your risk for serious side effects.||
1631|136|I|This document does not contain all possible drug interactions.||
1631|137|I|Keep a list of all the products you use (including||
1631|138|I|prescription/nonprescription drugs and herbal products) and share||
1631|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
1631|140|I|the dosage of any medicines without your doctor's approval.||
1631|141|I|   Other medications can affect the removal of suvorexant from||
1631|142|I|your body, which may affect how suvorexant works. Examples||
1631|143|I|include certain azole antifungals (such as itraconazole,||
1631|144|I|ketoconazole), certain drugs used to treat seizures (such as||
1631|145|I|carbamazepine, phenytoin), clarithromycin, cobicistat,||
1631|146|I|nefazodone, rifampin, ritonavir, telithromycin, among others.||
1631|147|I|   The risk of serious side effects (such as slow/shallow||
1631|148|I|breathing, severe drowsiness/dizziness) may be increased if this||
1631|149|I|medication is taken with other products that may also cause||
1631|150|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1631|151|I|if you are taking other products such as opioid pain or cough||
1631|152|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1631|153|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
1631|154|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1631|155|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1631|156|I|diphenhydramine).||
1631|157|I|   Check the labels on all your medicines (such as allergy or||
1631|158|I|cough-and-cold products) because they may contain ingredients||
1631|159|I|that cause drowsiness. Ask your pharmacist about using those||
1631|160|I|products safely.||
1631|161|B|||
1631|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1631|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1631|164|O|poison control center right away. US residents can call||
1631|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1631|166|O|Symptoms of overdose may include: a deep sleep from which you||
1631|167|O|cannot be awakened.||
1631|168|B|||
1631|169|N|NOTES:  Do not share this medication with others. Sharing it is||
1631|170|N|against the law.||
1631|171|N|   As you get older, your sleep pattern may naturally change and||
1631|172|N|your sleep may be interrupted several times during the night.||
1631|173|N|Consult your doctor or pharmacist for ways to improve your sleep||
1631|174|N|without medication, such as avoiding caffeine and alcohol close||
1631|175|N|to bedtime, avoiding daytime naps, and going to bed at the same||
1631|176|N|time each night.||
1631|177|B|||
1631|178|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
1631|179|D|time to sleep for at least 7 hours afterward.||
1631|180|B|||
1631|181|R|STORAGE:  Store in the original package at room temperature away||
1631|182|R|from light and moisture. Do not store in the bathroom. Keep all||
1631|183|R|medications away from children and pets.||
1631|184|R|   Do not flush medications down the toilet or pour them into a||
1631|185|R|drain unless instructed to do so. Properly discard this product||
1631|186|R|when it is expired or no longer needed. Consult your pharmacist||
1631|187|R|or local waste disposal company.||
1631|188|B|||
1631|189|A|Information last revised April 2025.||
1631|190|A|Copyright(c) 2025 First Databank, Inc.||
1631|191|B|||
1632|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1632|002|Z|does NOT have all possible information about this product. This||
1632|003|Z|information does not assure that this product is safe, effective,||
1632|004|Z|or appropriate for you. This information is not individual||
1632|005|Z|medical advice and does not substitute for the advice of your||
1632|006|Z|health care professional. Always ask your health care||
1632|007|Z|professional for complete information about this product and your||
1632|008|Z|specific health needs.||
1632|009|B|||
1632|010|T|CANAGLIFLOZIN/METFORMIN - ORAL||
1632|011|F|(KAN-a-gli-FLOE-zin/met-FOR-min)||
1632|012|B|||
1632|013|C|COMMON BRAND NAME(S): Invokamet||
1632|014|B|||
1632|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1632|016|W|cause a serious (sometimes fatal) condition called lactic||
1632|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1632|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1632|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1632|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1632|021|W|you are using certain drugs. For some conditions, your doctor may||
1632|022|W|tell you to stop taking this medication for a short time. Ask||
1632|023|W|your doctor or pharmacist for more details.||
1632|024|W|   Stop taking this medication and get medical help right away if||
1632|025|W|you have any symptoms of lactic acidosis, such as unusual||
1632|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1632|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1632|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1632|029|B|||
1632|030|U|USES:  This medication is a combination of 2 drugs: canagliflozin||
1632|031|U|and metformin. It is used with a proper diet and exercise program||
1632|032|U|to control high blood sugar in people with type 2 diabetes.||
1632|033|U|Controlling high blood sugar helps prevent kidney damage,||
1632|034|U|blindness, nerve problems, loss of limbs, and sexual function||
1632|035|U|problems. Proper control of diabetes may also lessen your risk of||
1632|036|U|a heart attack or stroke. This medication works by helping to||
1632|037|U|restore your body's proper response to the insulin you naturally||
1632|038|U|produce. It also increases the removal of sugar by your kidneys,||
1632|039|U|decreases how much sugar is made in your liver, and decreases how||
1632|040|U|much sugar your body takes in through your stomach and||
1632|041|U|intestines.||
1632|042|B|||
1632|043|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1632|044|H|Patient Information Leaflet provided by your pharmacist before||
1632|045|H|you start taking canagliflozin/metformin and each time you get a||
1632|046|H|refill. If you have any questions, ask your doctor or pharmacist.||
1632|047|H|   Take this medication by mouth as directed by your doctor,||
1632|048|H|usually twice a day with meals. Take this medication regularly to||
1632|049|H|get the most benefit from it. To help you remember, take it at||
1632|050|H|the same times each day. Drink plenty of fluids while taking this||
1632|051|H|medication unless otherwise directed by your doctor.||
1632|052|H|   The dosage is based on your medical condition, response to||
1632|053|H|treatment, and other medications you may be taking. Be sure to||
1632|054|H|tell your doctor and pharmacist about all the products you use||
1632|055|H|(including prescription drugs, nonprescription drugs, and herbal||
1632|056|H|products). To reduce your risk of side effects (such as upset||
1632|057|H|stomach), your doctor may direct you to start this medication at||
1632|058|H|a low dose and gradually increase your dose. Follow your doctor's||
1632|059|H|instructions carefully.||
1632|060|H|   Check your blood sugar regularly as directed by your doctor.||
1632|061|H|Keep track of the results, and share them with your doctor. Tell||
1632|062|H|your doctor if your blood sugar results are often too high or too||
1632|063|H|low. Your doctor may need to adjust your diabetes medication,||
1632|064|H|exercise program, or diet.||
1632|065|B|||
1632|066|S|SIDE EFFECTS:  See also Warning section.||
1632|067|S|   Nausea, vomiting, stomach upset, diarrhea, bloating/gas,||
1632|068|S|frequent urination, unusual dry mouth, or weakness may occur. If||
1632|069|S|any of these effects last or get worse, tell your doctor or||
1632|070|S|pharmacist promptly. If stomach symptoms return later (after||
1632|071|S|taking the same dose for several days or weeks), tell your doctor||
1632|072|S|right away. Stomach symptoms that occur after the first days of||
1632|073|S|your treatment may be signs of lactic acidosis.||
1632|074|S|   Remember that this medication has been prescribed because your||
1632|075|S|doctor has judged that the benefit to you is greater than the||
1632|076|S|risk of side effects. Many people using this medication do not||
1632|077|S|have serious side effects.||
1632|078|S|   Tell your doctor right away if you have any serious side||
1632|079|S|effects, including: signs of a urinary tract infection (such as||
1632|080|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1632|081|S|signs of kidney problems (such as change in the amount of urine,||
1632|082|S|swelling legs/feet), signs of high level of potassium in the||
1632|083|S|blood (such as muscle weakness and slow/irregular heartbeat).||
1632|084|S|   This medication may cause a new yeast infection in the vagina||
1632|085|S|or the penis. It may also cause a rare but very serious bacterial||
1632|086|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1632|087|S|your doctor right away if you have signs of a yeast infection in||
1632|088|S|the vagina (such as unusual vaginal||
1632|089|S|discharge/burning/itching/odor) or in the penis (such as||
1632|090|S|redness/itching/swelling of the penis, unusual discharge from the||
1632|091|S|penis). However, get medical help right away if you have any||
1632|092|S|pain/redness/swelling in or around the genital/anal area, along||
1632|093|S|with a fever or feeling unwell.||
1632|094|S|   This medication does not usually cause low blood sugar||
1632|095|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1632|096|S|prescribed with other diabetes medications, or if you do not get||
1632|097|S|enough calories from food, or if you do unusually heavy exercise.||
1632|098|S|Talk with your doctor or pharmacist about whether the dose of||
1632|099|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1632|100|S|of low blood sugar include sudden sweating, shaking, fast||
1632|101|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1632|102|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1632|103|S|treat low blood sugar. If you don't have these reliable forms of||
1632|104|S|glucose, rapidly raise your blood sugar by eating a quick source||
1632|105|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1632|106|S|juice or non-diet soda. Tell your doctor right away about the||
1632|107|S|reaction and the use of this product. To help prevent low blood||
1632|108|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1632|109|S|Check with your doctor or pharmacist to find out what you should||
1632|110|S|do if you miss a meal.||
1632|111|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1632|112|S|thirst/urination. If these symptoms occur, tell your doctor right||
1632|113|S|away. Your doctor may need to adjust your diabetes medication,||
1632|114|S|exercise program, or diet.||
1632|115|S|   Canagliflozin may rarely increase the risk of losing a lower||
1632|116|S|limb. This risk may be greater in people who have a history of||
1632|117|S|heart disease, blood circulation disease (peripheral vascular||
1632|118|S|disease), nerve problems (neuropathy), foot ulcers, or previous||
1632|119|S|loss of limbs. Talk to your doctor for more details. Tell your||
1632|120|S|doctor right away if you have any||
1632|121|S|pain/tenderness/redness/swelling/sores on your legs and feet.||
1632|122|S|   This medication may cause you to become dehydrated. This can||
1632|123|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1632|124|S|dehydration. Tell your doctor or pharmacist right away if you are||
1632|125|S|not able to drink fluids as usual, or losing fluid (such as due||
1632|126|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1632|127|S|right away if you have any signs of dehydration, such as||
1632|128|S|urinating less than usual, unusual dry mouth/thirst, fast||
1632|129|S|heartbeat, or dizziness/lightheadedness/fainting. To reduce the||
1632|130|S|risk of dizziness and lightheadedness, get up slowly when rising||
1632|131|S|from a sitting or lying position.||
1632|132|S|   Canagliflozin may cause some bone loss, or even a broken bone.||
1632|133|S|Lifestyle habits that help promote healthy bones include||
1632|134|S|weight-bearing exercises, stopping smoking, limiting alcohol, and||
1632|135|S|eating well-balanced meals that contain adequate calcium and||
1632|136|S|vitamin D. You may also need to take calcium and vitamin D||
1632|137|S|supplements. Talk to your doctor for specific advice.||
1632|138|S|   A very serious allergic reaction to this drug is rare.||
1632|139|S|However, get medical help right away if you notice any symptoms||
1632|140|S|of a serious allergic reaction, including: rash, itching/swelling||
1632|141|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1632|142|S|breathing.||
1632|143|S|   This is not a complete list of possible side effects. If you||
1632|144|S|notice other effects not listed above, contact your doctor or||
1632|145|S|pharmacist.||
1632|146|S|   In the US -||
1632|147|S|   Call your doctor for medical advice about side effects. You||
1632|148|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1632|149|S|www.fda.gov/medwatch.||
1632|150|S|   In Canada - Call your doctor for medical advice about side||
1632|151|S|effects. You may report side effects to Health Canada at||
1632|152|S|1-866-234-2345.||
1632|153|B|||
1632|154|P|PRECAUTIONS:  See also Warning and Side Effects section.||
1632|155|P|   Before taking this medication, tell your doctor or pharmacist||
1632|156|P|if you are allergic to canagliflozin or metformin; or if you have||
1632|157|P|any other allergies. This product may contain inactive||
1632|158|P|ingredients, which can cause allergic reactions or other||
1632|159|P|problems. Talk to your pharmacist for more details.||
1632|160|P|   Before using this medication, tell your doctor or pharmacist||
1632|161|P|your medical history, especially of: breathing problems (such as||
1632|162|P|asthma, obstructive lung disease), blood problems (such as||
1632|163|P|anemia, vitamin B12 deficiency), dehydration, use/abuse of||
1632|164|P|alcohol, low blood pressure, heart failure, kidney disease, liver||
1632|165|P|problems, disease of the pancreas (pancreatitis), blood mineral||
1632|166|P|imbalances (such as high levels of potassium), yeast infections||
1632|167|P|in the vagina or penis.||
1632|168|P|   Before having surgery or any X-ray/scanning procedure using||
1632|169|P|iodinated contrast, tell your doctor or dentist about all the||
1632|170|P|products you use (including prescription drugs, nonprescription||
1632|171|P|drugs, and herbal products). You may need to stop this medication||
1632|172|P|for a short time for the surgery/procedure. Ask your doctor or||
1632|173|P|dentist for instructions before your surgery/procedure.||
1632|174|P|   You may experience blurred vision, dizziness, or drowsiness||
1632|175|P|due to extremely low or high blood sugar. Do not drive, use||
1632|176|P|machinery, or do anything that needs alertness or clear vision||
1632|177|P|until you can do it safely.||
1632|178|P|   Limit alcohol while using this medication because it can||
1632|179|P|increase your risk of developing lactic acidosis, low blood||
1632|180|P|sugar, and a high ketone level.||
1632|181|P|   High fever, "water pills" (diuretics such as||
1632|182|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1632|183|P|may cause dehydration and increase your risk of lactic acidosis.||
1632|184|P|Stop taking this medication and tell your doctor right away if||
1632|185|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1632|186|P|fluids to prevent dehydration unless your doctor directs you||
1632|187|P|otherwise.||
1632|188|P|   It may be harder to control your blood sugar when your body is||
1632|189|P|stressed (such as due to fever, infection, injury, or surgery).||
1632|190|P|Also, if you are eating less or not able to eat due to these||
1632|191|P|conditions or any illness, this can lead to a high ketone level||
1632|192|P|while you are taking this medication. Consult your doctor because||
1632|193|P|this may require a change in your treatment plan, medications, or||
1632|194|P|blood sugar or ketone testing.||
1632|195|P|   Older adults may be at greater risk for side effects such as||
1632|196|P|low blood sugar, dehydration, lactic acidosis, dizziness/fainting||
1632|197|P|(usually when standing) or some bone loss.||
1632|198|P|   Metformin can cause changes in the menstrual cycle (promote||
1632|199|P|ovulation) and increase the risk of becoming pregnant. Consult||
1632|200|P|your doctor or pharmacist about the use of reliable birth control||
1632|201|P|while using this medication.||
1632|202|P|   During pregnancy, this medication should be used only when||
1632|203|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1632|204|P|benefits with your doctor.||
1632|205|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1632|206|P|your doctor for managing your blood sugar while pregnant. Your||
1632|207|P|doctor may change your diabetes treatment during your pregnancy||
1632|208|P|(such as diet and medications including insulin).||
1632|209|P|   Metformin passes into breast milk in small amounts. It is||
1632|210|P|unknown if canagliflozin passes into breast milk. Consult your||
1632|211|P|doctor before breastfeeding.||
1632|212|B|||
1632|213|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1632|214|I|medications work or increase your risk for serious side effects.||
1632|215|I|This document does not contain all possible drug interactions.||
1632|216|I|Keep a list of all the products you use (including||
1632|217|I|prescription/nonprescription drugs and herbal products) and share||
1632|218|I|it with your doctor and pharmacist. Do not start, stop, or change||
1632|219|I|the dosage of any medicines without your doctor's approval.||
1632|220|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1632|221|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1632|222|I|heartbeat you would usually feel when your blood sugar falls too||
1632|223|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1632|224|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1632|225|I|   Many drugs can affect your blood sugar, making it harder to||
1632|226|I|control. Before you start, stop, or change any medication, talk||
1632|227|I|with your doctor or pharmacist about how the medication may||
1632|228|I|affect your blood sugar. Check your blood sugar regularly as||
1632|229|I|directed and share the results with your doctor. Tell your doctor||
1632|230|I|right away if you have symptoms of high or low blood sugar. (See||
1632|231|I|also Side Effects section.) Your doctor may need to adjust your||
1632|232|I|diabetes medication, exercise program, or diet.||
1632|233|I|   This medication may interfere with certain lab tests (such as||
1632|234|I|urine glucose test), possibly causing false test results. Make||
1632|235|I|sure lab personnel and all your doctors know you use this drug.||
1632|236|B|||
1632|237|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1632|238|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1632|239|O|poison control center right away. US residents can call||
1632|240|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1632|241|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
1632|242|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
1632|243|O|rapid breathing, slow/irregular heartbeat.||
1632|244|B|||
1632|245|N|NOTES:  Do not share this medication with others.||
1632|246|N|   Attend a diabetes education program to learn more about how to||
1632|247|N|manage your diabetes with medications, diet, exercise, and||
1632|248|N|regular medical exams.||
1632|249|N|   Learn the symptoms of high and low blood sugar and how to||
1632|250|N|treat low blood sugar. Check your blood sugar regularly as||
1632|251|N|directed.||
1632|252|N|   Lab and/or medical tests (such as kidney function, liver||
1632|253|N|function, blood sugar, hemoglobin A1c, ketones, complete blood||
1632|254|N|counts, blood pressure, cholesterol, mineral levels including||
1632|255|N|potassium, bone density) should be done before you start taking||
1632|256|N|this medication and while you are taking it. Keep all medical and||
1632|257|N|lab appointments. Consult your doctor for more details.||
1632|258|B|||
1632|259|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1632|260|D|remember. If it is near the time of the next dose, skip the||
1632|261|D|missed dose. Take your next dose at the regular time. Do not||
1632|262|D|double the dose to catch up.||
1632|263|B|||
1632|264|R|STORAGE:  Store in the original bottle at room temperature away||
1632|265|R|from light and moisture. Do not store in the bathroom. If the||
1632|266|R|medication is kept in a pill box or medication reminder box, the||
1632|267|R|medication expires after 30 days. Keep all medications away from||
1632|268|R|children and pets.||
1632|269|R|   Do not flush medications down the toilet or pour them into a||
1632|270|R|drain unless instructed to do so. Properly discard this product||
1632|271|R|when it is expired or no longer needed. Consult your pharmacist||
1632|272|R|or local waste disposal company.||
1632|273|B|||
1632|274|M|MEDICAL ALERT:  Your condition can cause complications in a||
1632|275|M|medical emergency. For information about enrolling in MedicAlert,||
1632|276|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1632|277|B|||
1632|278|A|Information last revised November 2025.||
1632|279|A|Copyright(c) 2025 First Databank, Inc.||
1632|280|B|||
1633|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1633|002|Z|does NOT have all possible information about this product. This||
1633|003|Z|information does not assure that this product is safe, effective,||
1633|004|Z|or appropriate for you. This information is not individual||
1633|005|Z|medical advice and does not substitute for the advice of your||
1633|006|Z|health care professional. Always ask your health care||
1633|007|Z|professional for complete information about this product and your||
1633|008|Z|specific health needs.||
1633|009|B|||
1633|010|T|OLODATEROL - INHALATION||
1633|011|F|(OH-loe-DA-ter-ol)||
1633|012|B|||
1633|013|C|COMMON BRAND NAME(S): Striverdi Respimat||
1633|014|B|||
1633|015|U|USES:  Olodaterol is used as a long-term (maintenance) treatment||
1633|016|U|to prevent and decrease wheezing and shortness of breath caused||
1633|017|U|by breathing problems (such as chronic obstructive pulmonary||
1633|018|U|disease, including chronic bronchitis and emphysema). Olodaterol||
1633|019|U|belongs to the class of drugs known as long-acting beta agonists||
1633|020|U|(LABAs). Olodaterol is also known as a bronchodilator. It works||
1633|021|U|by relaxing the muscles around the airways so that they open up||
1633|022|U|and you can breathe more easily. Controlling symptoms of||
1633|023|U|breathing problems can decrease time lost from work or school.||
1633|024|U|   This medication does not work right away and should not be||
1633|025|U|used for sudden attacks of breathing trouble. Your doctor must||
1633|026|U|prescribe a quick-relief medicine/inhaler (such as albuterol,||
1633|027|U|also known as salbutamol) for sudden shortness of breath while||
1633|028|U|you are using olodaterol. You should always have a quick-relief||
1633|029|U|inhaler with you.||
1633|030|U|   Olodaterol is not approved to treat asthma. People with asthma||
1633|031|U|using long-acting inhaled beta agonists (such as olodaterol)||
1633|032|U|without also using an inhaled corticosteroid may have an||
1633|033|U|increased risk of serious (sometimes fatal) breathing problems.||
1633|034|B|||
1633|035|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1633|036|H|your pharmacist before you start using this medication and each||
1633|037|H|time you get a refill. Follow the illustrated directions for the||
1633|038|H|proper use of this medication. If you have any questions, ask||
1633|039|H|your doctor or pharmacist.||
1633|040|H|   Follow the instructions for priming the inhaler if you are||
1633|041|H|using it for the first time, or if you have not used it for a||
1633|042|H|long time (such as more than 3 days or 21 days). When priming the||
1633|043|H|inhaler, make sure to spray toward the ground (away from the||
1633|044|H|face) so that you do not get the medication into your eyes.||
1633|045|H|   Inhale this medication by mouth as directed by your doctor,||
1633|046|H|usually once daily. Wait at least 1 minute between each||
1633|047|H|inhalation.||
1633|048|H|   If you are using other inhalers at the same time, wait at||
1633|049|H|least 1 minute between the use of each medication.||
1633|050|H|   Do not use more of this medication or use it more often than||
1633|051|H|prescribed since this may cause serious side effects. Do not use||
1633|052|H|more than 2 inhalations of olodaterol a day.||
1633|053|H|   Use this medication regularly to get the most benefit from it.||
1633|054|H|To help you remember, use it at the same time each day. Do not||
1633|055|H|stop taking this medication without consulting your doctor.||
1633|056|H|   If you have been using a quick-relief inhaler (albuterol,||
1633|057|H|salbutamol) on a regular daily schedule (such as 4 times daily),||
1633|058|H|your doctor will direct you to stop this schedule and only use||
1633|059|H|the quick-relief inhaler as needed for sudden shortness of||
1633|060|H|breath. Consult your doctor for details.||
1633|061|H|   Learn which of your inhalers you should use every day and||
1633|062|H|which you should use if your breathing suddenly worsens||
1633|063|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1633|064|H|should do if you have new or worsening cough or shortness of||
1633|065|H|breath, wheezing, increased sputum, waking up at night with||
1633|066|H|trouble breathing, if you use your quick-relief inhaler more||
1633|067|H|often, or if your quick-relief inhaler does not seem to be||
1633|068|H|working well. Learn when you can treat sudden breathing problems||
1633|069|H|by yourself and when you must get medical help right away.||
1633|070|H|   Tell your doctor if your symptoms do not get better or if they||
1633|071|H|get worse.||
1633|072|B|||
1633|073|S|SIDE EFFECTS:  Nervousness, shaking (tremor), and trouble||
1633|074|S|sleeping may occur. If any of these effects last or get worse,||
1633|075|S|tell your doctor or pharmacist promptly.||
1633|076|S|   Remember that this medication has been prescribed because your||
1633|077|S|doctor has judged that the benefit to you is greater than the||
1633|078|S|risk of side effects. Many people using this medication do not||
1633|079|S|have serious side effects.||
1633|080|S|   This medication may raise your blood pressure. Check your||
1633|081|S|blood pressure regularly and tell your doctor if the results are||
1633|082|S|high.||
1633|083|S|   Tell your doctor right away if you have any serious side||
1633|084|S|effects, including: pounding heartbeat, muscle cramps/weakness,||
1633|085|S|increased thirst/urination, joint pain.||
1633|086|S|   Get medical help right away if you have any very serious side||
1633|087|S|effects, including: chest pain, rapid breathing, fast/irregular||
1633|088|S|heartbeat, severe dizziness, fainting.||
1633|089|S|   Rarely, this medication has caused severe (possibly fatal),||
1633|090|S|sudden worsening of breathing problems (paradoxical||
1633|091|S|bronchospasm). If you have trouble breathing or sudden wheezing,||
1633|092|S|use your quick-relief inhaler and get medical help right away.||
1633|093|S|   A very serious allergic reaction to this drug is rare.||
1633|094|S|However, get medical help right away if you notice any symptoms||
1633|095|S|of a serious allergic reaction, including: rash, itching/swelling||
1633|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1633|097|S|breathing.||
1633|098|S|   This is not a complete list of possible side effects. If you||
1633|099|S|notice other effects not listed above, contact your doctor or||
1633|100|S|pharmacist.||
1633|101|S|   In the US -||
1633|102|S|   Call your doctor for medical advice about side effects. You||
1633|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1633|104|S|www.fda.gov/medwatch.||
1633|105|S|   In Canada - Call your doctor for medical advice about side||
1633|106|S|effects. You may report side effects to Health Canada at||
1633|107|S|1-866-234-2345.||
1633|108|B|||
1633|109|P|PRECAUTIONS:  Before taking olodaterol, tell your doctor or||
1633|110|P|pharmacist if you are allergic to it; or if you have any other||
1633|111|P|allergies. This product may contain inactive ingredients, which||
1633|112|P|can cause allergic reactions or other problems. Talk to your||
1633|113|P|pharmacist for more details.||
1633|114|P|   Before using this medication, tell your doctor or pharmacist||
1633|115|P|your medical history, especially of: heart problems (such as||
1633|116|P|irregular heartbeat, angina, previous heart attack), high blood||
1633|117|P|pressure, diabetes, seizures, overactive thyroid||
1633|118|P|(hyperthyroidism).||
1633|119|P|   Olodaterol may cause a condition that affects the heart rhythm||
1633|120|P|(QT prolongation). QT prolongation can rarely cause serious||
1633|121|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1633|122|P|as severe dizziness, fainting) that need medical attention right||
1633|123|P|away.||
1633|124|P|   The risk of QT prolongation may be increased if you have||
1633|125|P|certain medical conditions or are taking other drugs that may||
1633|126|P|cause QT prolongation. Before using olodaterol, tell your doctor||
1633|127|P|or pharmacist of all the drugs you take and if you have any of||
1633|128|P|the following conditions: certain heart problems (heart failure,||
1633|129|P|slow heartbeat, QT prolongation in the EKG), family history of||
1633|130|P|certain heart problems (QT prolongation in the EKG, sudden||
1633|131|P|cardiac death).||
1633|132|P|   Low levels of potassium or magnesium in the blood may also||
1633|133|P|increase your risk of QT prolongation. This risk may increase if||
1633|134|P|you use certain drugs (such as diuretics/"water pills") or if you||
1633|135|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1633|136|P|Talk to your doctor about using olodaterol safely.||
1633|137|P|   Before having surgery, tell your doctor or dentist about all||
1633|138|P|the products you use (including prescription drugs,||
1633|139|P|nonprescription drugs, and herbal products).||
1633|140|P|   Older adults may be more sensitive to the side effects of this||
1633|141|P|drug, especially QT prolongation (see above).||
1633|142|P|   During pregnancy, this medication should be used only when||
1633|143|P|clearly needed. Discuss the risks and benefits with your doctor.||
1633|144|P|   It is unknown if this medication passes into breast milk.||
1633|145|P|Consult your doctor before breastfeeding.||
1633|146|B|||
1633|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1633|148|I|medications work or increase your risk for serious side effects.||
1633|149|I|This document does not contain all possible drug interactions.||
1633|150|I|Keep a list of all the products you use (including||
1633|151|I|prescription/nonprescription drugs and herbal products) and share||
1633|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
1633|153|I|the dosage of any medicines without your doctor's approval.||
1633|154|I|   Do not use other LABA drugs (such as formoterol, salmeterol)||
1633|155|I|while using this medication.||
1633|156|B|||
1633|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1633|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1633|159|O|poison control center right away. US residents can call||
1633|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1633|161|O|Symptoms of overdose may include: chest pain, fast/irregular||
1633|162|O|heartbeat, severe dizziness, fainting.||
1633|163|B|||
1633|164|N|NOTES:  Do not share this medication with others.||
1633|165|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
1633|166|N|lung function) should be done while you are using this||
1633|167|N|medication. Keep all medical and lab appointments. Consult your||
1633|168|N|doctor for more details.||
1633|169|N|   Avoid substances that can worsen breathing problems by causing||
1633|170|N|irritation or allergic reactions, such as smoke, pollen, pet||
1633|171|N|dander, dust, and mold.||
1633|172|N|   Because the flu virus can worsen breathing problems, ask your||
1633|173|N|doctor or pharmacist if you should have a flu shot every year.||
1633|174|B|||
1633|175|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1633|176|D|If it is near the time of the next dose, skip the missed dose.||
1633|177|D|Use your next dose at the regular time. Do not double the dose to||
1633|178|D|catch up.||
1633|179|B|||
1633|180|R|STORAGE:  Store at room temperature. Do not freeze. Once the||
1633|181|R|cartridge is put into the inhaler, this medication expires after||
1633|182|R|3 months. Keep all medications away from children and pets.||
1633|183|R|   Do not flush medications down the toilet or pour them into a||
1633|184|R|drain unless instructed to do so. Properly discard this product||
1633|185|R|when it is expired or no longer needed. Consult your pharmacist||
1633|186|R|or local waste disposal company.||
1633|187|B|||
1633|188|M|MEDICAL ALERT:  Your condition can cause complications in a||
1633|189|M|medical emergency. For information about enrolling in MedicAlert,||
1633|190|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1633|191|B|||
1633|192|A|Information last revised January 2025.||
1633|193|A|Copyright(c) 2025 First Databank, Inc.||
1633|194|B|||
1634|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1634|002|Z|does NOT have all possible information about this product. This||
1634|003|Z|information does not assure that this product is safe, effective,||
1634|004|Z|or appropriate for you. This information is not individual||
1634|005|Z|medical advice and does not substitute for the advice of your||
1634|006|Z|health care professional. Always ask your health care||
1634|007|Z|professional for complete information about this product and your||
1634|008|Z|specific health needs.||
1634|009|B|||
1634|010|T|EMPAGLIFLOZIN - ORAL||
1634|011|F|(EM-pa-gli-FLOE-zin)||
1634|012|B|||
1634|013|C|COMMON BRAND NAME(S): Jardiance||
1634|014|B|||
1634|015|U|USES:  Empagliflozin is used with a proper diet and exercise||
1634|016|U|program to control high blood sugar in people with type 2||
1634|017|U|diabetes. Controlling high blood sugar helps prevent kidney||
1634|018|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1634|019|U|function problems. Empagliflozin is also used in patients with||
1634|020|U|type 2 diabetes and heart disease to lower the risk of death from||
1634|021|U|heart attack or stroke. Empagliflozin works by increasing the||
1634|022|U|removal of sugar by your kidneys.||
1634|023|U|   Empagliflozin is also used to treat heart failure and kidney||
1634|024|U|disease. It helps to lower the risk of death from heart disease||
1634|025|U|and reduces the need of going to a hospital to treat heart||
1634|026|U|failure or kidney disease. It also helps to lower the risk of||
1634|027|U|dialysis in people with kidney disease. Empagliflozin works by||
1634|028|U|increasing the removal of sodium by your kidneys.||
1634|029|B|||
1634|030|H|HOW TO USE:  Read the Medication Guide provided by your||
1634|031|H|pharmacist before you start taking empagliflozin and each time||
1634|032|H|you get a refill. If you have any questions, ask your doctor or||
1634|033|H|pharmacist.||
1634|034|H|   Take this medication by mouth with or without food as directed||
1634|035|H|by your doctor, usually once daily in the morning. The dosage is||
1634|036|H|based on your medical condition and response to treatment.||
1634|037|H|   Use this medication regularly to get the most benefit from it.||
1634|038|H|To help you remember, take it at the same time each day.||
1634|039|H|   Tell your doctor if your condition does not get better or if||
1634|040|H|it gets worse.||
1634|041|B|||
1634|042|S|SIDE EFFECTS:  Frequent urination, dizziness, or lightheadedness||
1634|043|S|may occur. If any of these effects last or get worse, tell your||
1634|044|S|doctor or pharmacist promptly.||
1634|045|S|   To reduce the risk of dizziness and lightheadedness, get up||
1634|046|S|slowly when rising from a sitting or lying position.||
1634|047|S|   Remember that this medication has been prescribed because your||
1634|048|S|doctor has judged that the benefit to you is greater than the||
1634|049|S|risk of side effects. Many people using this medication do not||
1634|050|S|have serious side effects.||
1634|051|S|   Tell your doctor right away if you have any serious side||
1634|052|S|effects, including: signs of a urinary tract infection (such as||
1634|053|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1634|054|S|signs of kidney problems (such as change in the amount of urine).||
1634|055|S|   Get medical help right away if you have any very serious side||
1634|056|S|effects, including: unusual tiredness, nausea/vomiting,||
1634|057|S|stomach/abdominal pain, trouble breathing.||
1634|058|S|   This medication may cause a new yeast infection in the vagina||
1634|059|S|or the penis. It may also cause a rare but very serious bacterial||
1634|060|S|infection in the genital/anal area (Fournier's gangrene) in||
1634|061|S|people with type 2 diabetes. Tell your doctor right away if you||
1634|062|S|have signs of a yeast infection in the vagina (such as unusual||
1634|063|S|vaginal discharge/burning/itching/odor) or in the penis (such as||
1634|064|S|redness/itching/swelling of the penis, unusual discharge from the||
1634|065|S|penis). However, get medical help right away if you have any||
1634|066|S|pain/redness/swelling in or around the genital/anal area, along||
1634|067|S|with a fever or feeling unwell.||
1634|068|S|   This medication may increase the risk of lower limb amputation||
1634|069|S|(especially of the toe and foot). The risk is higher if you have||
1634|070|S|poor blood flow in the legs, nerve problems, foot ulcers, or have||
1634|071|S|had a previous amputation. To lessen the risk, check your feet||
1634|072|S|regularly and tell your doctor if you have new pain, tenderness,||
1634|073|S|sores, or ulcers on your legs or feet.||
1634|074|S|   This medication may cause you to become dehydrated. This can||
1634|075|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1634|076|S|dehydration. Tell your doctor or pharmacist right away if you are||
1634|077|S|not able to drink fluids as usual, or losing fluid (such as due||
1634|078|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1634|079|S|right away if you have any signs of dehydration, such as||
1634|080|S|urinating less than usual, unusual dry mouth/thirst, fast||
1634|081|S|heartbeat, or dizziness/lightheadedness/fainting.||
1634|082|S|   If you are taking empagliflozin for diabetes, empagliflozin||
1634|083|S|does not usually cause low blood sugar (hypoglycemia). Low blood||
1634|084|S|sugar may occur if this drug is prescribed with other diabetes||
1634|085|S|medications, or if you do not get enough calories from food, or||
1634|086|S|if you do unusually heavy exercise. Talk with your doctor or||
1634|087|S|pharmacist about whether the dose of your other diabetes||
1634|088|S|medication(s) needs to be lowered. Symptoms of low blood sugar||
1634|089|S|include sudden sweating, shaking, fast heartbeat, hunger, blurred||
1634|090|S|vision, dizziness, or tingling hands/feet. It is a good habit to||
1634|091|S|carry glucose tablets or gel to treat low blood sugar. If you||
1634|092|S|don't have these reliable forms of glucose, rapidly raise your||
1634|093|S|blood sugar by eating a quick source of sugar such as table||
1634|094|S|sugar, honey, or candy, or drink fruit juice or non-diet soda.||
1634|095|S|Tell your doctor right away about the reaction and the use of||
1634|096|S|this product. To help prevent low blood sugar, eat meals on a||
1634|097|S|regular schedule, and do not skip meals. Check with your doctor||
1634|098|S|or pharmacist to find out what you should do if you miss a meal.||
1634|099|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1634|100|S|thirst/urination. If these symptoms occur, tell your doctor right||
1634|101|S|away. Your doctor may need to adjust your diabetes medication,||
1634|102|S|exercise program, or diet.||
1634|103|S|   A very serious allergic reaction to this drug is rare.||
1634|104|S|However, get medical help right away if you notice any symptoms||
1634|105|S|of a serious allergic reaction, including: rash, itching/swelling||
1634|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1634|107|S|breathing.||
1634|108|S|   This is not a complete list of possible side effects. If you||
1634|109|S|notice other effects not listed above, contact your doctor or||
1634|110|S|pharmacist.||
1634|111|S|   In the US -||
1634|112|S|   Call your doctor for medical advice about side effects. You||
1634|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1634|114|S|www.fda.gov/medwatch.||
1634|115|S|   In Canada - Call your doctor for medical advice about side||
1634|116|S|effects. You may report side effects to Health Canada at||
1634|117|S|1-866-234-2345.||
1634|118|B|||
1634|119|P|PRECAUTIONS:  Before taking empagliflozin, tell your doctor or||
1634|120|P|pharmacist if you are allergic to it; or if you have any other||
1634|121|P|allergies. This product may contain inactive ingredients, which||
1634|122|P|can cause allergic reactions or other problems. Talk to your||
1634|123|P|pharmacist for more details.||
1634|124|P|   Before using this medication, tell your doctor or pharmacist||
1634|125|P|your medical history, especially of: kidney problems (such as||
1634|126|P|kidney dialysis), liver problems, disease of the pancreas||
1634|127|P|(pancreatitis), dehydration, use/abuse of alcohol, low blood||
1634|128|P|pressure, high cholesterol, history of yeast infections in the||
1634|129|P|vagina or penis, blocked or narrowed blood vessels, usually in||
1634|130|P|the leg, nerve problems (such as diabetic peripheral neuropathy),||
1634|131|P|foot sores or ulcers, amputation.||
1634|132|P|   If you have diabetes, you may experience blurred vision,||
1634|133|P|dizziness, or drowsiness due to extremely low or high blood||
1634|134|P|sugar. Do not drive, use machinery, or do anything that needs||
1634|135|P|alertness or clear vision until you can do it safely. Limit||
1634|136|P|alcohol while taking this medication because it can increase your||
1634|137|P|risk of developing low blood sugar and a high ketone level.||
1634|138|P|   If you have diabetes, it may be harder to control your blood||
1634|139|P|sugar when your body is stressed (such as due to fever,||
1634|140|P|infection, injury, or surgery). Also, if you are eating less or||
1634|141|P|not able to eat due to these conditions or any illness, this can||
1634|142|P|lead to a high ketone level while you are taking this medication.||
1634|143|P|Consult your doctor because this may require a change in your||
1634|144|P|treatment plan, medications, or blood sugar or ketone testing.||
1634|145|P|   Before having surgery, tell your doctor or dentist about all||
1634|146|P|the products you use (including prescription drugs,||
1634|147|P|nonprescription drugs, and herbal products).||
1634|148|P|   Children may be at greater risk for low blood sugar while||
1634|149|P|using this drug.||
1634|150|P|   Older adults may be more sensitive to the side effects of this||
1634|151|P|drug, especially dehydration, kidney problems, and||
1634|152|P|dizziness/fainting (usually when standing).||
1634|153|P|   During pregnancy, this medication should be used only when||
1634|154|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1634|155|P|benefits with your doctor.||
1634|156|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1634|157|P|your doctor for managing your blood sugar while pregnant. Your||
1634|158|P|doctor may change your diabetes treatment during your pregnancy||
1634|159|P|(such as diet and medications including insulin).||
1634|160|P|   It is unknown if this drug passes into breast milk. Consult||
1634|161|P|your doctor before breastfeeding.||
1634|162|B|||
1634|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1634|164|I|medications work or increase your risk for serious side effects.||
1634|165|I|This document does not contain all possible drug interactions.||
1634|166|I|Keep a list of all the products you use (including||
1634|167|I|prescription/nonprescription drugs and herbal products) and share||
1634|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
1634|169|I|the dosage of any medicines without your doctor's approval.||
1634|170|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1634|171|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1634|172|I|heartbeat you would usually feel when your blood sugar falls too||
1634|173|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1634|174|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1634|175|I|   Many drugs can affect blood sugar, making it harder to control||
1634|176|I|in people with diabetes. Before you start, stop, or change any||
1634|177|I|medication, talk with your doctor or pharmacist about how the||
1634|178|I|medication may affect your blood sugar if you have diabetes.||
1634|179|I|Check your blood sugar regularly as directed and share the||
1634|180|I|results with your doctor. Tell your doctor right away if you have||
1634|181|I|symptoms of high or low blood sugar. (See also Side Effects||
1634|182|I|section.) Your doctor may need to adjust your diabetes||
1634|183|I|medication, exercise program, or diet.||
1634|184|I|   This medication may interfere with certain lab tests (such as||
1634|185|I|urine glucose test), possibly causing false test results. Make||
1634|186|I|sure lab personnel and all your doctors know you use this drug.||
1634|187|B|||
1634|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1634|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1634|190|O|poison control center right away. US residents can call||
1634|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1634|192|B|||
1634|193|N|NOTES:  Do not share this medication with others.||
1634|194|N|   Lab and/or medical tests (such as kidney function, blood||
1634|195|N|pressure, blood sugar, cholesterol, ketones) may be done before||
1634|196|N|you start taking this medication and while you are taking it.||
1634|197|N|Keep all medical and lab appointments. Consult your doctor for||
1634|198|N|more details.||
1634|199|N|   If you have diabetes, attend a diabetes education program to||
1634|200|N|learn more about how to manage your diabetes with medications,||
1634|201|N|diet, exercise, and regular medical exams. Learn the symptoms of||
1634|202|N|high and low blood sugar and how to treat low blood sugar. Check||
1634|203|N|your blood sugar regularly as directed.||
1634|204|B|||
1634|205|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1634|206|D|remember. If it is near the time of the next dose, skip the||
1634|207|D|missed dose. Take your next dose at the regular time. Do not||
1634|208|D|double the dose to catch up.||
1634|209|B|||
1634|210|R|STORAGE:  Store at room temperature away from light and moisture.||
1634|211|R|Do not store in the bathroom. Keep all medications away from||
1634|212|R|children and pets.||
1634|213|R|   Do not flush medications down the toilet or pour them into a||
1634|214|R|drain unless instructed to do so. Properly discard this product||
1634|215|R|when it is expired or no longer needed. Consult your pharmacist||
1634|216|R|or local waste disposal company.||
1634|217|B|||
1634|218|M|MEDICAL ALERT:  Your condition can cause complications in a||
1634|219|M|medical emergency. For information about enrolling in MedicAlert,||
1634|220|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1634|221|B|||
1634|222|A|Information last revised May 2025.||
1634|223|A|Copyright(c) 2025 First Databank, Inc.||
1634|224|B|||
1635|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1635|002|Z|does NOT have all possible information about this product. This||
1635|003|Z|information does not assure that this product is safe, effective,||
1635|004|Z|or appropriate for you. This information is not individual||
1635|005|Z|medical advice and does not substitute for the advice of your||
1635|006|Z|health care professional. Always ask your health care||
1635|007|Z|professional for complete information about this product and your||
1635|008|Z|specific health needs.||
1635|009|B|||
1635|010|T|DROXIDOPA - ORAL||
1635|011|F|(DROX-i-DOE-pa)||
1635|012|B|||
1635|013|C|COMMON BRAND NAME(S): Northera||
1635|014|B|||
1635|015|W|WARNING:  This medication can increase your blood pressure when||
1635|016|W|you are lying on your back (supine hypertension). Raising the||
1635|017|W|head of the your bed lessens this risk. Your doctor will||
1635|018|W|carefully monitor your blood pressure in this position before and||
1635|019|W|during treatment, especially after a dosage increase. Your doctor||
1635|020|W|may adjust or stop treatment with this medication if supine||
1635|021|W|hypertension happens and cannot be managed by raising the head of||
1635|022|W|your bed. If supine hypertension cannot be managed, it could lead||
1635|023|W|to a stroke, heart attack, or even death. Talk with your doctor||
1635|024|W|for details.||
1635|025|B|||
1635|026|U|USES:  Droxidopa is used to treat symptoms of low blood pressure||
1635|027|U|when standing, caused by a certain medical condition (neurogenic||
1635|028|U|orthostatic hypotension-NOH). This medication can lessen symptoms||
1635|029|U|of low blood pressure when standing (orthostatic hypotension),||
1635|030|U|such as dizziness, lightheadedness, or the "feeling that you are||
1635|031|U|about to black out." Droxidopa is used by people whose daily||
1635|032|U|activities are severely affected by this condition, even after||
1635|033|U|other treatments are used (such as support stockings, water||
1635|034|U|bolus). It is thought to work by making the blood vessels become||
1635|035|U|more narrow, which increases blood pressure.||
1635|036|B|||
1635|037|H|HOW TO USE:  Take this medication by mouth as directed by your||
1635|038|H|doctor, usually 3 times a day (morning, midday, and late||
1635|039|H|afternoon). Swallow the capsules whole. You may take this||
1635|040|H|medication with or without food, but it is important to choose||
1635|041|H|one way and take this medication the same way with every dose.||
1635|042|H|This drug is taken during daytime hours, when people stand most||
1635|043|H|often. It should not be taken after the evening meal or less than||
1635|044|H|3 hours before bedtime.||
1635|045|H|   The dosage is based on your medical condition and response to||
1635|046|H|treatment. To reduce your risk of side effects, your doctor may||
1635|047|H|direct you to start this medication at a low dose and gradually||
1635|048|H|increase your dose. Follow your doctor's instructions carefully.||
1635|049|H|   Use this medication regularly to get the most benefit from it.||
1635|050|H|To help you remember, take it at the same times each day.||
1635|051|H|   Since it is unknown if this medication will work longer than 2||
1635|052|H|weeks, it should be continued only if symptoms continue to get||
1635|053|H|better during treatment. Do not take this medication for longer||
1635|054|H|than 2 weeks unless your doctor directs you to do so. Learn how||
1635|055|H|to monitor your own blood pressure and share the results with||
1635|056|H|your doctor. Tell your doctor if your condition does not get||
1635|057|H|better or if it gets worse.||
1635|058|B|||
1635|059|S|SIDE EFFECTS:  See also Warning section.||
1635|060|S|   Headache, nausea, or dizziness may occur. If any of these||
1635|061|S|effects last or get worse, tell your doctor or pharmacist||
1635|062|S|promptly.||
1635|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
1635|064|S|slowly when rising from a sitting or lying position.||
1635|065|S|   Remember that this medication has been prescribed because your||
1635|066|S|doctor has judged that the benefit to you is greater than the||
1635|067|S|risk of side effects. Many people using this medication do not||
1635|068|S|have serious side effects.||
1635|069|S|   This medication can increase your blood pressure, especially||
1635|070|S|when you are lying down (supine hypertension). Monitor and share||
1635|071|S|your blood pressure results with your doctor. Tell your doctor if||
1635|072|S|you have symptoms of high blood pressure, such as pounding||
1635|073|S|heartbeat, pounding sound in your ears, headache, or blurred||
1635|074|S|vision.||
1635|075|S|   This medication may rarely cause very serious symptoms that||
1635|076|S|are like a condition called neuroleptic malignant syndrome (NMS).||
1635|077|S|These symptoms may be more likely to happen when your dose of||
1635|078|S|this drug or other medications (such as levodopa) is changed. Get||
1635|079|S|medical help right away if you have any of the following||
1635|080|S|symptoms: fever, muscle stiffness, severe confusion, sweating,||
1635|081|S|fast/irregular heartbeat.||
1635|082|S|   A very serious allergic reaction to this drug is rare.||
1635|083|S|However, get medical help right away if you notice any symptoms||
1635|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1635|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1635|086|S|breathing.||
1635|087|S|   This is not a complete list of possible side effects. If you||
1635|088|S|notice other effects not listed above, contact your doctor or||
1635|089|S|pharmacist.||
1635|090|S|   In the US -||
1635|091|S|   Call your doctor for medical advice about side effects. You||
1635|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1635|093|S|www.fda.gov/medwatch.||
1635|094|S|   In Canada - Call your doctor for medical advice about side||
1635|095|S|effects. You may report side effects to Health Canada at||
1635|096|S|1-866-234-2345.||
1635|097|B|||
1635|098|P|PRECAUTIONS:  See also Warning section.||
1635|099|P|   Before taking droxidopa, tell your doctor or pharmacist if you||
1635|100|P|are allergic to it; or if you have any other allergies. This||
1635|101|P|product may contain inactive ingredients, which can cause||
1635|102|P|allergic reactions or other problems. Talk to your pharmacist for||
1635|103|P|more details.||
1635|104|P|   Before using this medication, tell your doctor or pharmacist||
1635|105|P|your medical history, especially of: heart problems (such as||
1635|106|P|irregular heartbeat, heart failure, previous heart attack),||
1635|107|P|kidney disease.||
1635|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1635|109|P|can make you more dizzy. Do not drive, use machinery, or do||
1635|110|P|anything that needs alertness until you can do it safely. Limit||
1635|111|P|alcoholic beverages. Talk to your doctor if you are using||
1635|112|P|marijuana (cannabis).||
1635|113|P|   This medication increases your blood pressure. Raise the head||
1635|114|P|of your bed to lessen the risk of high blood pressure that||
1635|115|P|happens when lying down (supine hypertension).||
1635|116|P|   Before having surgery, tell your doctor or dentist about all||
1635|117|P|the products you use (including prescription drugs,||
1635|118|P|nonprescription drugs, and herbal products).||
1635|119|P|   During pregnancy, this medication should be used only when||
1635|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
1635|121|P|   It is unknown if this medication passes into breast milk.||
1635|122|P|Consult your doctor before breastfeeding.||
1635|123|B|||
1635|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1635|125|I|medications work or increase your risk for serious side effects.||
1635|126|I|This document does not contain all possible drug interactions.||
1635|127|I|Keep a list of all the products you use (including||
1635|128|I|prescription/nonprescription drugs and herbal products) and share||
1635|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
1635|130|I|the dosage of any medicines without your doctor's approval.||
1635|131|B|||
1635|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1635|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1635|134|O|poison control center right away. US residents can call||
1635|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1635|136|B|||
1635|137|N|NOTES:  Do not share this medication with others.||
1635|138|N|   Learn about other ways to help manage symptoms of neurogenic||
1635|139|N|orthostatic hypotension-NOH, such as drinking plenty of fluids,||
1635|140|N|taking salt supplements/table salt, or wearing an abdominal||
1635|141|N|binder and leg stockings. Also, certain physical movements (such||
1635|142|N|as toe-raise, leg-crossing, thigh contraction) can help make you||
1635|143|N|be able to stay upright a longer time. Ask your doctor for more||
1635|144|N|details.||
1635|145|N|   Lab and/or medical tests (such as blood pressure) should be||
1635|146|N|done while you are taking this medication. Keep all medical and||
1635|147|N|lab appointments. Consult your doctor for more details.||
1635|148|B|||
1635|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1635|150|D|remember. If it is near the time of the next dose, skip the||
1635|151|D|missed dose. Take your next dose at the regular time. Do not||
1635|152|D|double the dose to catch up.||
1635|153|B|||
1635|154|R|STORAGE:  Store at room temperature away from light and moisture.||
1635|155|R|Do not store in the bathroom. Keep all medications away from||
1635|156|R|children and pets.||
1635|157|R|   Do not flush medications down the toilet or pour them into a||
1635|158|R|drain unless instructed to do so. Properly discard this product||
1635|159|R|when it is expired or no longer needed. Consult your pharmacist||
1635|160|R|or local waste disposal company.||
1635|161|B|||
1635|162|A|Information last revised November 2024.||
1635|163|A|Copyright(c) 2025 First Databank, Inc.||
1635|164|B|||
1636|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1636|002|Z|does NOT have all possible information about this product. This||
1636|003|Z|information does not assure that this product is safe, effective,||
1636|004|Z|or appropriate for you. This information is not individual||
1636|005|Z|medical advice and does not substitute for the advice of your||
1636|006|Z|health care professional. Always ask your health care||
1636|007|Z|professional for complete information about this product and your||
1636|008|Z|specific health needs.||
1636|009|B|||
1636|010|T|ABACAVIR/DOLUTEGRAVIR/LAMIVUDINE - ORAL||
1636|011|F|(a-BAK-a-vir/DOE-loo-TEG-ra-vir/la-MIV-ue-deen)||
1636|012|B|||
1636|013|C|COMMON BRAND NAME(S): Triumeq||
1636|014|B|||
1636|015|W|WARNING:  In some people, the abacavir in this product has caused||
1636|016|W|a serious (sometimes fatal) allergic reaction. Your doctor should||
1636|017|W|order a blood test to measure your risk before you start this||
1636|018|W|medication or take it again. If the blood test shows you are at||
1636|019|W|greater risk, you should not take this medication and your doctor||
1636|020|W|should discuss other treatment choices with you. Symptoms of an||
1636|021|W|allergic reaction may include any of the following: rash,||
1636|022|W|itching/swelling (especially of the face/tongue/throat), severe||
1636|023|W|dizziness, trouble breathing, fever, extreme tiredness, nausea,||
1636|024|W|vomiting, diarrhea, stomach pain, muscle aches/pain, joint pain,||
1636|025|W|sore throat, mouth sores, blisters, eye redness/swelling, or||
1636|026|W|cough. Get medical help right away if you experience any of these||
1636|027|W|symptoms. If you have stopped taking abacavir because of an||
1636|028|W|allergic reaction, you must never take any form of abacavir||
1636|029|W|again, or death could result. Tell all of your doctors and||
1636|030|W|pharmacists if you have stopped taking abacavir due to an||
1636|031|W|allergic reaction. Also, properly throw away any unused||
1636|032|W|medications containing abacavir. Read the warning card provided||
1636|033|W|with this medication for more details.||
1636|034|W|   You should be tested for hepatitis B infection before starting||
1636|035|W|this medication. If you have hepatitis B infection and HIV, you||
1636|036|W|may need additional drugs to treat the hepatitis B infection. You||
1636|037|W|may also have a serious worsening of hepatitis symptoms if you||
1636|038|W|stop taking lamivudine. Talk with your doctor before stopping||
1636|039|W|this medication. Your doctor will monitor liver tests for several||
1636|040|W|months after you stop lamivudine. Get medical help right away if||
1636|041|W|you develop symptoms of worsening liver problems.||
1636|042|B|||
1636|043|U|USES:  This product contains 3 drugs: abacavir, dolutegravir, and||
1636|044|U|lamivudine. It is used to help control HIV infection. It helps to||
1636|045|U|decrease the amount of HIV in your body so your immune system can||
1636|046|U|work better. This lowers your chance of getting HIV complications||
1636|047|U|(such as new infections, cancer) and improves your quality of||
1636|048|U|life. Abacavir and lamivudine belong to a class of drugs known as||
1636|049|U|nucleoside reverse transcriptase inhibitors (NRTIs). Dolutegravir||
1636|050|U|belongs to a class of drugs known as integrase inhibitors.||
1636|051|U|   This medication is not a cure for HIV infection. To decrease||
1636|052|U|your risk of spreading HIV disease to others, continue to take||
1636|053|U|all HIV medications exactly as prescribed by your doctor. Use an||
1636|054|U|effective barrier method (latex or polyurethane condoms/dental||
1636|055|U|dams) during sexual activity as directed by your doctor. Do not||
1636|056|U|share personal items (such as needles/syringes, toothbrushes, and||
1636|057|U|razors) that may have contacted blood or other body fluids.||
1636|058|U|Consult your doctor or pharmacist for more details.||
1636|059|B|||
1636|060|H|HOW TO USE:  Read the Medication Guide and Warning Card provided||
1636|061|H|by your pharmacist before you start taking this medication and||
1636|062|H|each time you get a refill. Carry the Warning Card with you at||
1636|063|H|all times. If you have any questions, ask your doctor or||
1636|064|H|pharmacist.||
1636|065|H|   Do not change dosage forms of this medication without checking||
1636|066|H|with your doctor or pharmacist.||
1636|067|H|   Take this medication by mouth with or without food as directed||
1636|068|H|by your doctor, usually once daily. Do not chew, cut, or crush||
1636|069|H|the tablets. If you are taking certain other medications, your||
1636|070|H|doctor may direct you to take additional dolutegravir. Carefully||
1636|071|H|follow your doctor's directions.||
1636|072|H|   Take this medication at least 2 hours before or 6 hours after||
1636|073|H|taking sucralfate and products containing aluminum or magnesium||
1636|074|H|(such as antacids, laxatives, buffered medications). These||
1636|075|H|products bind with dolutegravir, decreasing its effectiveness.||
1636|076|H|   If you are also taking calcium or iron supplements (including||
1636|077|H|vitamins/minerals that contain calcium or iron), take this||
1636|078|H|medication at least 2 hours before or 6 hours after these||
1636|079|H|products. Or if you take this medication with food, you can take||
1636|080|H|the supplements at the same time.||
1636|081|H|   If you stop taking any medication containing abacavir even for||
1636|082|H|a short time and then restart the drug, you have an increased||
1636|083|H|chance of developing a very serious (possibly fatal) allergic||
1636|084|H|reaction. Refill your medication before you run out. Do not stop||
1636|085|H|treatment unless directed by your doctor. Before restarting any||
1636|086|H|medication containing abacavir, consult your doctor or||
1636|087|H|pharmacist, and be sure you have easy access to medical care.||
1636|088|H|   It is very important to keep taking this medication (and other||
1636|089|H|HIV medications) exactly as prescribed by your doctor. Do not||
1636|090|H|skip any doses.||
1636|091|H|   For the best effect, take this medication at evenly spaced||
1636|092|H|times. To help you remember, take this medication at the same||
1636|093|H|time every day.||
1636|094|H|   Do not take more or less of this drug than prescribed or stop||
1636|095|H|taking it (or other HIV medicines) even for a short time unless||
1636|096|H|directed to do so by your doctor. Doing so may cause the amount||
1636|097|H|of virus to increase, make the infection more difficult to treat||
1636|098|H|(resistant), or worsen side effects.||
1636|099|B|||
1636|100|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1636|101|S|   Remember that this medication has been prescribed because your||
1636|102|S|doctor has judged that the benefit to you is greater than the||
1636|103|S|risk of side effects. Many people using this medication do not||
1636|104|S|have serious side effects.||
1636|105|S|   As your immune system gets stronger, it can begin to fight off||
1636|106|S|infections you already had, possibly causing disease symptoms to||
1636|107|S|come back. You could also have symptoms if your immune system||
1636|108|S|becomes overactive. This reaction may happen at any time (soon||
1636|109|S|after starting HIV treatment or many months later). Tell your||
1636|110|S|doctor right away if you have any serious symptoms, including:||
1636|111|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1636|112|S|that doesn't go away, headaches that are severe or don't go away,||
1636|113|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1636|114|S|changes, signs of infection (such as sore throat that doesn't go||
1636|115|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1636|116|S|sores), signs of an overactive thyroid (such as irritability,||
1636|117|S|nervousness, heat intolerance, fast/pounding/irregular||
1636|118|S|heartbeat).||
1636|119|S|   Tell your doctor right away if you have any serious side||
1636|120|S|effects, including: mental/mood changes (such as depression,||
1636|121|S|anxiety), easy bruising/bleeding, signs of anemia (such as||
1636|122|S|unusual tiredness, fast breathing, pale skin, fast heartbeat),||
1636|123|S|signs of kidney problems (such as change in the amount of urine).||
1636|124|S|   Get medical help right away if you have any very serious side||
1636|125|S|effects, including: signs of pancreatitis (such as nausea,||
1636|126|S|vomiting, stomach/abdominal/back pain, fever).||
1636|127|S|   Rarely, this medication has caused severe (sometimes fatal)||
1636|128|S|liver problems and a buildup of lactic acid in the blood (lactic||
1636|129|S|acidosis). These serious side effects may occur more often in||
1636|130|S|women and obese patients. Get medical help right away if you have||
1636|131|S|any of the following serious symptoms, including: symptoms of||
1636|132|S|liver problems (such as nausea/vomiting that doesn't stop, loss||
1636|133|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1636|134|S|urine), symptoms of lactic acidosis (such as deep/rapid||
1636|135|S|breathing, drowsiness, nausea/vomiting).||
1636|136|S|   This is not a complete list of possible side effects. If you||
1636|137|S|notice other effects not listed above, contact your doctor or||
1636|138|S|pharmacist.||
1636|139|S|   In the US -||
1636|140|S|   Call your doctor for medical advice about side effects. You||
1636|141|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1636|142|S|www.fda.gov/medwatch.||
1636|143|S|   In Canada - Call your doctor for medical advice about side||
1636|144|S|effects. You may report side effects to Health Canada at||
1636|145|S|1-866-234-2345.||
1636|146|B|||
1636|147|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1636|148|P|pharmacist if you are allergic to abacavir, dolutegravir, or||
1636|149|P|lamivudine; or if you have any other allergies. This product may||
1636|150|P|contain inactive ingredients, which can cause allergic reactions||
1636|151|P|or other problems. Talk to your pharmacist for more details.||
1636|152|P|   Before using this medication, tell your doctor or pharmacist||
1636|153|P|your medical history, especially of: kidney problems, liver||
1636|154|P|problems (such as hepatitis B or C, cirrhosis), disease of the||
1636|155|P|pancreas (pancreatitis), alcohol use.||
1636|156|P|   Abacavir may increase your risk of a heart attack. Discuss the||
1636|157|P|risks and benefits of treatment with your doctor and ways to||
1636|158|P|lower your risk of heart disease. Tell your doctor if you have||
1636|159|P|heart problems, if you smoke, or if you have other conditions||
1636|160|P|that increase your risk of heart disease, such as high blood||
1636|161|P|pressure, diabetes, or high cholesterol levels.||
1636|162|P|   Limit alcoholic beverages, because they can increase the risk||
1636|163|P|of liver problems and pancreatitis.||
1636|164|P|   Before having surgery, tell your doctor or dentist about all||
1636|165|P|the products you use (including prescription drugs,||
1636|166|P|nonprescription drugs, and herbal products).||
1636|167|P|   Tell your doctor if you are pregnant before using this||
1636|168|P|medication. Treatment can lower the risk of passing HIV infection||
1636|169|P|to your baby. Discuss the risks and benefits with your doctor.||
1636|170|P|   This medication passes into breast milk. Because breast milk||
1636|171|P|may transmit HIV, consult your doctor before breastfeeding.||
1636|172|B|||
1636|173|I|DRUG INTERACTIONS:  See also How to Use section.||
1636|174|I|   Drug interactions may change how your medications work or||
1636|175|I|increase your risk for serious side effects. This document does||
1636|176|I|not contain all possible drug interactions. Keep a list of all||
1636|177|I|the products you use (including prescription/nonprescription||
1636|178|I|drugs and herbal products) and share it with your doctor and||
1636|179|I|pharmacist. Do not start, stop, or change the dosage of any||
1636|180|I|medicines without your doctor's approval.||
1636|181|I|   Some products that may interact with this drug include:||
1636|182|I|dofetilide, orlistat, sorbitol.||
1636|183|I|   Do not take this medication with other products (including||
1636|184|I|those that treat HIV infection) that contain abacavir,||
1636|185|I|lamivudine, or emtricitabine.||
1636|186|B|||
1636|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1636|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1636|189|O|poison control center right away. US residents can call||
1636|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1636|191|B|||
1636|192|N|NOTES:  Do not share this medication with others.||
1636|193|N|   Lab and/or medical tests (such as viral load, T-cell counts,||
1636|194|N|blood tests, liver/kidney function) should be done while you are||
1636|195|N|taking this medication. Keep all medical and lab appointments.||
1636|196|B|||
1636|197|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1636|198|D|remember. If it is less than 4 hours before the next dose, skip||
1636|199|D|the missed dose. Take your next dose at the regular time. Do not||
1636|200|D|double the dose to catch up.||
1636|201|B|||
1636|202|R|STORAGE:  Store in the original bottle at room temperature away||
1636|203|R|from light and moisture. Do not store in the bathroom. Keep the||
1636|204|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1636|205|R|when not in use. Keep all medications away from children and||
1636|206|R|pets.||
1636|207|R|   Do not flush medications down the toilet or pour them into a||
1636|208|R|drain unless instructed to do so. Properly discard this product||
1636|209|R|when it is expired or no longer needed. Consult your pharmacist||
1636|210|R|or local waste disposal company.||
1636|211|B|||
1636|212|A|Information last revised April 2025.||
1636|213|A|Copyright(c) 2025 First Databank, Inc.||
1636|214|B|||
1637|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1637|002|Z|does NOT have all possible information about this product. This||
1637|003|Z|information does not assure that this product is safe, effective,||
1637|004|Z|or appropriate for you. This information is not individual||
1637|005|Z|medical advice and does not substitute for the advice of your||
1637|006|Z|health care professional. Always ask your health care||
1637|007|Z|professional for complete information about this product and your||
1637|008|Z|specific health needs.||
1637|009|B|||
1637|010|T|C1-ESTERASE INHIBITOR (TREATMENT), RECOMBINANT - INJECTION||
1637|011|B|||
1637|012|C|COMMON BRAND NAME(S): Ruconest||
1637|013|B|||
1637|014|U|USES:  This medication is used to treat the swelling problems||
1637|015|U|caused by a certain immune disease passed down through families||
1637|016|U|(hereditary angioedema-HAE). HAE is caused by low levels or||
1637|017|U|improper function of a natural substance produced by the body||
1637|018|U|(C1-esterase inhibitor). Symptoms such as rapid swelling of the||
1637|019|U|hands, feet, limbs, face, tongue, or throat can occur. Swelling||
1637|020|U|of the intestinal tract may cause symptoms such as abdominal||
1637|021|U|cramps, diarrhea, or vomiting. Attacks of swelling may occur||
1637|022|U|without reason. However, anxiety, stress, sickness, and surgery||
1637|023|U|may trigger attacks in some people. This medication works by||
1637|024|U|increasing the level of C1-esterase inhibitor to help treat||
1637|025|U|attacks of sudden swelling due to hereditary angioedema.||
1637|026|B|||
1637|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1637|028|H|from your pharmacist before you start using C1-esterase inhibitor||
1637|029|H|and each time you get a refill. If you have any questions, ask||
1637|030|H|your doctor or pharmacist.||
1637|031|H|   This medication is given by injection into a vein, at the||
1637|032|H|first signs of an HAE attack, as directed by your doctor. The||
1637|033|H|dosage is based on weight and your medical condition. Do not use||
1637|034|H|more than 4,200 international units per dose. Do not use more||
1637|035|H|than 2 doses in a 24-hour period.||
1637|036|H|   If you are using this medication at home, learn all||
1637|037|H|preparation and usage instructions from your health care||
1637|038|H|professional. If the medication and the solution used to mix it||
1637|039|H|have been refrigerated, bring both to room temperature before||
1637|040|H|mixing. Before using, check this product for particles or||
1637|041|H|discoloration. If either is present, do not use the liquid. Learn||
1637|042|H|how to store and discard medical supplies safely.||
1637|043|H|   After giving yourself a dose of this medication, you should||
1637|044|H|get medical help right away for follow-up treatment.||
1637|045|H|   Tell your doctor if your condition does not get better or if||
1637|046|H|it gets worse.||
1637|047|B|||
1637|048|S|SIDE EFFECTS:  Headache may occur. If this effect lasts or gets||
1637|049|S|worse, tell your doctor or pharmacist promptly.||
1637|050|S|   Remember that this medication has been prescribed because your||
1637|051|S|doctor has judged that the benefit to you is greater than the||
1637|052|S|risk of side effects. Many people using this medication do not||
1637|053|S|have serious side effects.||
1637|054|S|   This medication may rarely cause serious problems from blood||
1637|055|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1637|056|S|legs). You may be at increased risk for blood clots if you have a||
1637|057|S|history of blood clots, heart/blood vessel disease, heart||
1637|058|S|failure, stroke, or if you are immobile (possibly for reasons||
1637|059|S|like being on a very long plane flight or being bedridden). If||
1637|060|S|you use estrogen-containing products, these may also increase||
1637|061|S|your risk. Before using this medication, if you have any of these||
1637|062|S|conditions report them to your doctor or pharmacist. Get medical||
1637|063|S|help right away if any of these side effects occur: shortness of||
1637|064|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
1637|065|S|sweating, confusion, sudden dizziness/fainting, new||
1637|066|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1637|067|S|weakness on one side of the body, sudden vision changes, trouble||
1637|068|S|speaking.||
1637|069|S|   A very serious allergic reaction to this drug is rare.||
1637|070|S|However, get medical help right away if you notice any symptoms||
1637|071|S|of a serious allergic reaction, including: rash, itching/swelling||
1637|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1637|073|S|breathing.||
1637|074|S|   This is not a complete list of possible side effects. If you||
1637|075|S|notice other effects not listed above, contact your doctor or||
1637|076|S|pharmacist.||
1637|077|S|   In the US -||
1637|078|S|   Call your doctor for medical advice about side effects. You||
1637|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1637|080|S|www.fda.gov/medwatch.||
1637|081|S|   In Canada - Call your doctor for medical advice about side||
1637|082|S|effects. You may report side effects to Health Canada at||
1637|083|S|1-866-234-2345.||
1637|084|B|||
1637|085|P|PRECAUTIONS:  Before using C1-esterase inhibitor, tell your||
1637|086|P|doctor or pharmacist if you are allergic to it; or to rabbits or||
1637|087|P|rabbit-based products; or if you have any other allergies. This||
1637|088|P|product may contain inactive ingredients, which can cause||
1637|089|P|allergic reactions or other problems. Talk to your pharmacist for||
1637|090|P|more details.||
1637|091|P|   Before using this medication, tell your doctor or pharmacist||
1637|092|P|your medical history, especially of: blood clots (such as in the||
1637|093|P|lungs, legs).||
1637|094|P|   Before traveling, talk to your doctor to make sure you have||
1637|095|P|enough of this medication.||
1637|096|P|   Before having surgery, tell your doctor or dentist about all||
1637|097|P|the products you use (including prescription drugs,||
1637|098|P|nonprescription drugs, and herbal products).||
1637|099|P|   During pregnancy, this medication should be used only when||
1637|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
1637|101|P|   It is unknown if this drug passes into breast milk. Consult||
1637|102|P|your doctor before breastfeeding.||
1637|103|B|||
1637|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1637|105|I|medications work or increase your risk for serious side effects.||
1637|106|I|This document does not contain all possible drug interactions.||
1637|107|I|Keep a list of all the products you use (including||
1637|108|I|prescription/nonprescription drugs and herbal products) and share||
1637|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
1637|110|I|the dosage of any medicines without your doctor's approval.||
1637|111|B|||
1637|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1637|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1637|114|O|poison control center right away. US residents can call||
1637|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1637|116|B|||
1637|117|N|NOTES:  Do not share this medication with others.||
1637|118|B|||
1637|119|D|MISSED DOSE:  Not applicable.||
1637|120|B|||
1637|121|R|STORAGE:  Store the unmixed vial in the refrigerator or at room||
1637|122|R|temperature away from light. Do not freeze. Keep the medication||
1637|123|R|in the original carton until ready to use. After mixing, use this||
1637|124|R|medication immediately or within the time period noted in the||
1637|125|R|product instructions. Discard any unused portion. Keep all||
1637|126|R|medications away from children and pets.||
1637|127|R|   Do not flush medications down the toilet or pour them into a||
1637|128|R|drain unless instructed to do so. Properly discard this product||
1637|129|R|when it is expired or no longer needed. Consult your pharmacist||
1637|130|R|or local waste disposal company.||
1637|131|B|||
1637|132|A|Information last revised November 2024.||
1637|133|A|Copyright(c) 2025 First Databank, Inc.||
1637|134|B|||
1638|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1638|002|Z|does NOT have all possible information about this product. This||
1638|003|Z|information does not assure that this product is safe, effective,||
1638|004|Z|or appropriate for you. This information is not individual||
1638|005|Z|medical advice and does not substitute for the advice of your||
1638|006|Z|health care professional. Always ask your health care||
1638|007|Z|professional for complete information about this product and your||
1638|008|Z|specific health needs.||
1638|009|B|||
1638|010|T|ORITAVANCIN - INJECTION||
1638|011|F|(or-IT-a-VAN-sin)||
1638|012|B|||
1638|013|C|COMMON BRAND NAME(S): Kimyrsa, Orbactiv||
1638|014|B|||
1638|015|U|USES:  This medication is an antibiotic used to treat serious||
1638|016|U|bacterial infections of the skin. It works by stopping the growth||
1638|017|U|of bacteria.||
1638|018|B|||
1638|019|H|HOW TO USE:  This medication is given by a health care||
1638|020|H|professional as a single dose. Depending on your product, this||
1638|021|H|medication is injected slowly into a vein over 1 or 3 hours.||
1638|022|H|   Infusion reactions may happen during the infusion of this||
1638|023|H|drug. Tell your doctor right away if you have any symptoms of||
1638|024|H|infusion reactions such as flushing of the upper body, back/chest||
1638|025|H|pain, chills, or shaking. Your doctor may slow down or stop your||
1638|026|H|treatment for some time.||
1638|027|H|   Tell your doctor if your condition lasts or gets worse.||
1638|028|B|||
1638|029|S|SIDE EFFECTS:  See also How to Use section.||
1638|030|S|   Nausea, vomiting, or headache may occur. If any of these||
1638|031|S|effects last or get worse, tell your doctor or pharmacist||
1638|032|S|promptly.||
1638|033|S|   Remember that this medication has been prescribed because your||
1638|034|S|doctor has judged that the benefit to you is greater than the||
1638|035|S|risk of side effects. Many people using this medication do not||
1638|036|S|have serious side effects.||
1638|037|S|   Tell your doctor right away if you have any serious side||
1638|038|S|effects, including: bone pain, fast heartbeat, unusual tiredness,||
1638|039|S|swelling ankles/feet/hands.||
1638|040|S|   This medication may rarely cause a severe intestinal condition||
1638|041|S|due to a bacteria called C. difficile. This condition may occur||
1638|042|S|during treatment or weeks to months after treatment has stopped.||
1638|043|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1638|044|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1638|045|S|stool.||
1638|046|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1638|047|S|products because they may make symptoms worse.||
1638|048|S|   Use of this medication for prolonged or repeated periods may||
1638|049|S|result in oral thrush or a new yeast infection. Contact your||
1638|050|S|doctor if you notice white patches in your mouth, a change in||
1638|051|S|vaginal discharge, or other new symptoms.||
1638|052|S|   A very serious allergic reaction to this drug is rare.||
1638|053|S|However, get medical help right away if you notice any symptoms||
1638|054|S|of a serious allergic reaction, including: rash, itching/swelling||
1638|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1638|056|S|breathing.||
1638|057|S|   This is not a complete list of possible side effects. If you||
1638|058|S|notice other effects not listed above, contact your doctor or||
1638|059|S|pharmacist.||
1638|060|S|   In the US -||
1638|061|S|   Call your doctor for medical advice about side effects. You||
1638|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1638|063|S|www.fda.gov/medwatch.||
1638|064|S|   In Canada - Call your doctor for medical advice about side||
1638|065|S|effects. You may report side effects to Health Canada at||
1638|066|S|1-866-234-2345.||
1638|067|B|||
1638|068|P|PRECAUTIONS:  Before using oritavancin, tell your doctor or||
1638|069|P|pharmacist if you are allergic to it; or if you have any other||
1638|070|P|allergies. This product may contain inactive ingredients, which||
1638|071|P|can cause allergic reactions or other problems. Talk to your||
1638|072|P|pharmacist for more details.||
1638|073|P|   Before using this medication, tell your doctor or pharmacist||
1638|074|P|your medical history. See also Drug Interactions section.||
1638|075|P|   Oritavancin may cause live bacterial vaccines (such as typhoid||
1638|076|P|vaccine) to not work well. Tell your health care professional||
1638|077|P|that you are using oritavancin before having any||
1638|078|P|immunizations/vaccinations.||
1638|079|P|   Before having surgery, tell your doctor or dentist about all||
1638|080|P|the products you use (including prescription drugs,||
1638|081|P|nonprescription drugs, and herbal products).||
1638|082|P|   During pregnancy, this medication should be used only when||
1638|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
1638|084|P|   It is unknown if this drug passes into breast milk. Consult||
1638|085|P|your doctor before breastfeeding.||
1638|086|B|||
1638|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1638|088|I|medications work or increase your risk for serious side effects.||
1638|089|I|This document does not contain all possible drug interactions.||
1638|090|I|Keep a list of all the products you use (including||
1638|091|I|prescription/nonprescription drugs and herbal products) and share||
1638|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
1638|093|I|the dosage of any medicines without your doctor's approval.||
1638|094|I|   One product that may interact with this drug is: heparin.||
1638|095|I|   This medication may interfere with certain lab tests||
1638|096|I|(including blood clotting tests such as PT/INR/aPTT), possibly||
1638|097|I|causing false test results. Make sure lab personnel and all your||
1638|098|I|doctors know you use this drug, and if you are using warfarin or||
1638|099|I|are being treated for bleeding/clotting disorders.||
1638|100|B|||
1638|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1638|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1638|103|O|poison control center right away. US residents can call||
1638|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1638|105|B|||
1638|106|N|NOTES:  Lab and/or medical tests (such as liver function) may be||
1638|107|N|done while you are using this medication. Keep all medical and||
1638|108|N|lab appointments. Consult your doctor for more details.||
1638|109|B|||
1638|110|D|MISSED DOSE:  Not applicable.||
1638|111|B|||
1638|112|R|STORAGE:  Not applicable. This medication is given in a hospital||
1638|113|R|and will not be stored at home.||
1638|114|B|||
1638|115|A|Information last revised May 2024.||
1638|116|A|Copyright(c) 2025 First Databank, Inc.||
1638|117|B|||
1639|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1639|002|Z|does NOT have all possible information about this product. This||
1639|003|Z|information does not assure that this product is safe, effective,||
1639|004|Z|or appropriate for you. This information is not individual||
1639|005|Z|medical advice and does not substitute for the advice of your||
1639|006|Z|health care professional. Always ask your health care||
1639|007|Z|professional for complete information about this product and your||
1639|008|Z|specific health needs.||
1639|009|B|||
1639|010|T|TAVABOROLE - TOPICAL||
1639|011|F|(TA-va-BOR-ole)||
1639|012|B|||
1639|013|C|COMMON BRAND NAME(S): Kerydin||
1639|014|B|||
1639|015|U|USES:  This medication is used to treat toenail infection caused||
1639|016|U|by fungus. It works by stopping the growth of certain types of||
1639|017|U|fungus. Tavaborole belongs to a class of drugs known as oxaborole||
1639|018|U|antifungals.||
1639|019|U|   This medication treats only fungal infections. It will not||
1639|020|U|work for other types of infection, such as those caused by||
1639|021|U|bacteria. Unnecessary use or misuse of any drug used to treat||
1639|022|U|infection can lead to its decreased effectiveness.||
1639|023|B|||
1639|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
1639|025|H|Instructions for Use if available from your pharmacist before you||
1639|026|H|start using tavaborole and each time you get a refill. If you||
1639|027|H|have any questions, ask your doctor or pharmacist.||
1639|028|H|   Before applying this medication, clean and dry the infected||
1639|029|H|toenail(s). Use this medication only on the infected toenail(s)||
1639|030|H|as directed by your doctor, usually once daily for 48 weeks. If||
1639|031|H|this medication is used on a child, an adult should apply it for||
1639|032|H|them.||
1639|033|H|   Using the provided dropper, apply to the infected toenail(s).||
1639|034|H|Slowly squeeze the bulb to apply enough solution to completely||
1639|035|H|cover your toenail. Use the dropper tip to gently spread the||
1639|036|H|medication over the toenail up to the edges, and under the tip of||
1639|037|H|the toenail. Repeat for each affected toenail. After applying,||
1639|038|H|wait about 2 minutes to let the solution dry completely before||
1639|039|H|wearing socks, shoes, or other footwear. If the solution comes in||
1639|040|H|contact with skin around the toenail(s), use a tissue to wipe any||
1639|041|H|excess solution from the surrounding skin. Wash your hands with||
1639|042|H|soap and water after applying the medication.||
1639|043|H|   Avoid getting this medication on any other part of your body.||
1639|044|H|If this accidentally happens, wipe off the medication and rinse||
1639|045|H|thoroughly with water.||
1639|046|H|   Use this medication regularly to get the most benefit from it.||
1639|047|H|To help you remember, use it at the same time each day. Continue||
1639|048|H|to use this medication for the full time prescribed, even if||
1639|049|H|symptoms disappear after a few days. Nail fungus treatment||
1639|050|H|usually must be continued a long time so that healthy nails can||
1639|051|H|grow and replace the infected toenail(s). Stopping the medication||
1639|052|H|too early may result in a return of the infection.||
1639|053|H|   Tell your doctor if your condition does not get better or if||
1639|054|H|it gets worse.||
1639|055|H|   This medication is flammable until dry. Avoid smoking or being||
1639|056|H|near open flames while using the medication and until the||
1639|057|H|medication has dried.||
1639|058|B|||
1639|059|S|SIDE EFFECTS:  Application site irritation, redness, itching,||
1639|060|S|swelling, or skin peeling may occur. Ingrown toenails may also||
1639|061|S|occur. If any of these effects last or get worse, stop using this||
1639|062|S|medication and tell your doctor or pharmacist promptly.||
1639|063|S|   Remember that this medication has been prescribed because your||
1639|064|S|doctor has judged that the benefit to you is greater than the||
1639|065|S|risk of side effects. Many people using this medication do not||
1639|066|S|have serious side effects.||
1639|067|S|   A very serious allergic reaction to this drug is rare.||
1639|068|S|However, get medical help right away if you notice any symptoms||
1639|069|S|of a serious allergic reaction, including: rash, itching/swelling||
1639|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1639|071|S|breathing.||
1639|072|S|   This is not a complete list of possible side effects. If you||
1639|073|S|notice other effects not listed above, contact your doctor or||
1639|074|S|pharmacist.||
1639|075|S|   In the US -||
1639|076|S|   Call your doctor for medical advice about side effects. You||
1639|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1639|078|S|www.fda.gov/medwatch.||
1639|079|S|   In Canada - Call your doctor for medical advice about side||
1639|080|S|effects. You may report side effects to Health Canada at||
1639|081|S|1-866-234-2345.||
1639|082|B|||
1639|083|P|PRECAUTIONS:  Before using tavaborole, tell your doctor or||
1639|084|P|pharmacist if you are allergic to it; or if you have any other||
1639|085|P|allergies. This product may contain inactive ingredients, which||
1639|086|P|can cause allergic reactions or other problems. Talk to your||
1639|087|P|pharmacist for more details.||
1639|088|P|   Before using this medication, tell your doctor or pharmacist||
1639|089|P|your medical history.||
1639|090|P|   Before having surgery, tell your doctor or dentist about all||
1639|091|P|the products you use (including prescription drugs,||
1639|092|P|nonprescription drugs, and herbal products).||
1639|093|P|   During pregnancy, this medication should be used only when||
1639|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
1639|095|P|   It is unknown if this drug passes into breast milk. Consult||
1639|096|P|your doctor before breastfeeding.||
1639|097|B|||
1639|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1639|099|I|medications work or increase your risk for serious side effects.||
1639|100|I|This document does not contain all possible drug interactions.||
1639|101|I|Keep a list of all the products you use (including||
1639|102|I|prescription/nonprescription drugs and herbal products) and share||
1639|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
1639|104|I|the dosage of any medicines without your doctor's approval.||
1639|105|B|||
1639|106|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1639|107|O|has overdosed and has serious symptoms such as passing out or||
1639|108|O|trouble breathing, call 911. Otherwise, call a poison control||
1639|109|O|center right away. US residents can call 1-800-222-1222. Canada||
1639|110|O|residents can call 1-844-764-7669.||
1639|111|B|||
1639|112|N|NOTES:  Do not share this medication with others.||
1639|113|N|   This medication has been prescribed for your current condition||
1639|114|N|only. Do not use it later for another condition unless your||
1639|115|N|doctor directs you to do so. A different medication may be||
1639|116|N|necessary in that case.||
1639|117|B|||
1639|118|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1639|119|D|If it is near the time of the next dose, skip the missed dose.||
1639|120|D|Use your next dose at the regular time. Do not apply more of this||
1639|121|D|medication to try to catch up.||
1639|122|B|||
1639|123|R|STORAGE:  Store upright at room temperature. Do not freeze. This||
1639|124|R|product is flammable. Keep it away from heat and open flame. Once||
1639|125|R|the bottle is opened, this medication expires after 3 months.||
1639|126|R|Keep all medications away from children and pets.||
1639|127|R|   Do not flush medications down the toilet or pour them into a||
1639|128|R|drain unless instructed to do so. Properly discard this product||
1639|129|R|when it is expired or no longer needed. Consult your pharmacist||
1639|130|R|or local waste disposal company.||
1639|131|B|||
1639|132|A|Information last revised July 2025.||
1639|133|A|Copyright(c) 2025 First Databank, Inc.||
1639|134|B|||
1640|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1640|002|Z|does NOT have all possible information about this product. This||
1640|003|Z|information does not assure that this product is safe, effective,||
1640|004|Z|or appropriate for you. This information is not individual||
1640|005|Z|medical advice and does not substitute for the advice of your||
1640|006|Z|health care professional. Always ask your health care||
1640|007|Z|professional for complete information about this product and your||
1640|008|Z|specific health needs.||
1640|009|B|||
1640|010|T|SILDENAFIL SUSPENSION (LUNGS) - ORAL||
1640|011|F|(sil-DEN-a-fil)||
1640|012|B|||
1640|013|C|COMMON BRAND NAME(S): Liqrev, Revatio||
1640|014|B|||
1640|015|U|USES:  Sildenafil is used to treat high blood pressure in the||
1640|016|U|lungs (pulmonary hypertension). It works by relaxing and widening||
1640|017|U|the blood vessels in your lungs which allows the blood to flow||
1640|018|U|more easily. Decreasing high blood pressure in the lungs allows||
1640|019|U|your heart and lungs to work better and improves your ability to||
1640|020|U|exercise.||
1640|021|B|||
1640|022|V|OTHER USES:  This section contains uses of this drug that are not||
1640|023|V|listed in the approved professional labeling for the drug but||
1640|024|V|that may be prescribed by your health care professional. Use this||
1640|025|V|drug for a condition that is listed in this section only if it||
1640|026|V|has been so prescribed by your health care professional.||
1640|027|V|   Sildenafil is also available in other brands and other||
1640|028|V|strengths for erectile dysfunction-ED in men.||
1640|029|B|||
1640|030|H|HOW TO USE:  Read the Patient Information Leaflet and||
1640|031|H|Instructions for Use if available from your pharmacist before you||
1640|032|H|start taking sildenafil and each time you get a refill. If you||
1640|033|H|have any questions, ask your doctor or pharmacist.||
1640|034|H|   To treat high blood pressure in the lungs, take this||
1640|035|H|medication by mouth with or without food as directed by your||
1640|036|H|doctor, usually 3 times a day. Shake the bottle well for 10||
1640|037|H|seconds before each dose. Carefully measure the dose using a||
1640|038|H|special measuring device/spoon. Do not use a household spoon||
1640|039|H|because you may not get the correct dose.||
1640|040|H|   The dosage is based on your medical condition, response to||
1640|041|H|treatment, and other medications you may be taking. Be sure to||
1640|042|H|tell your doctor and pharmacist about all the products you use||
1640|043|H|(including prescription drugs, nonprescription drugs, and herbal||
1640|044|H|products). Children's dosage is also based on weight.||
1640|045|H|   Do not increase your dose or take this drug more often than||
1640|046|H|prescribed. Your condition will not improve any faster, and your||
1640|047|H|risk of side effects will increase.||
1640|048|H|   Do not mix with any other medications/liquids.||
1640|049|H|   Take this medication regularly to get the most benefit from||
1640|050|H|it. To help you remember, take it at the same times each day.||
1640|051|H|   Tell your doctor if your condition does not get better or if||
1640|052|H|it gets worse.||
1640|053|B|||
1640|054|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, flushing,||
1640|055|S|stomach upset, nosebleeds, trouble sleeping, or swollen||
1640|056|S|hands/ankles/feet (edema) may occur. Vision changes such as||
1640|057|S|increased sensitivity to light, blurred vision, or trouble||
1640|058|S|telling blue and green colors apart may also occur. If any of||
1640|059|S|these effects last or get worse, tell your doctor or pharmacist||
1640|060|S|promptly.||
1640|061|S|   To reduce the risk of dizziness and lightheadedness, get up||
1640|062|S|slowly when rising from a sitting or lying position.||
1640|063|S|   Remember that this medication has been prescribed because your||
1640|064|S|doctor has judged that the benefit to you is greater than the||
1640|065|S|risk of side effects. Many people using this medication do not||
1640|066|S|have serious side effects.||
1640|067|S|   Rarely, sudden decreased vision, or even permanent blindness,||
1640|068|S|may occur in one or both eyes (NAION). If this serious problem||
1640|069|S|occurs, stop taking sildenafil and get medical help right away.||
1640|070|S|You have a slightly greater chance of developing NAION if you||
1640|071|S|have heart disease, diabetes, high cholesterol, certain other eye||
1640|072|S|problems ("crowded disk"), high blood pressure, if you are over||
1640|073|S|50, or if you smoke.||
1640|074|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
1640|075|S|ringing in the ears and dizziness, may occur. Stop taking||
1640|076|S|sildenafil and get medical help right away if these effects||
1640|077|S|occur.||
1640|078|S|   Rarely, males may have a painful or prolonged erection lasting||
1640|079|S|4 or more hours. If this occurs, stop using this drug and get||
1640|080|S|medical help right away, or permanent problems could occur.||
1640|081|S|   Get medical help right away if you have any very serious side||
1640|082|S|effects, including: increased shortness of breath or trouble||
1640|083|S|breathing, fainting.||
1640|084|S|   A very serious allergic reaction to this drug is rare.||
1640|085|S|However, get medical help right away if you notice any symptoms||
1640|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1640|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1640|088|S|breathing.||
1640|089|S|   This is not a complete list of possible side effects. If you||
1640|090|S|notice other effects not listed above, contact your doctor or||
1640|091|S|pharmacist.||
1640|092|S|   In the US -||
1640|093|S|   Call your doctor for medical advice about side effects. You||
1640|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1640|095|S|www.fda.gov/medwatch.||
1640|096|S|   In Canada - Call your doctor for medical advice about side||
1640|097|S|effects. You may report side effects to Health Canada at||
1640|098|S|1-866-234-2345.||
1640|099|B|||
1640|100|P|PRECAUTIONS:  Before taking sildenafil, tell your doctor or||
1640|101|P|pharmacist if you are allergic to it; or if you have any other||
1640|102|P|allergies. This product may contain inactive ingredients which||
1640|103|P|can cause allergic reactions or other problems. Talk to your||
1640|104|P|pharmacist for more details.||
1640|105|P|   Before using this medication, tell your doctor or pharmacist||
1640|106|P|your medical history, especially of: heart problems (such as||
1640|107|P|heart attack or life-threatening irregular heartbeat in the past||
1640|108|P|6 months, chest pain/angina, heart failure), stroke in the past 6||
1640|109|P|months, high or low blood pressure, dehydration, penis conditions||
1640|110|P|(such as angulation, fibrosis/scarring, Peyronie's disease),||
1640|111|P|history of painful/prolonged erection (priapism), conditions that||
1640|112|P|may increase the risk of priapism (such as sickle cell anemia,||
1640|113|P|leukemia, multiple myeloma), eye problems (such as retinitis||
1640|114|P|pigmentosa, sudden decreased vision, NAION), other lung||
1640|115|P|conditions (such as pulmonary veno-occlusive disease).||
1640|116|P|   This drug may make you dizzy or cause vision problems. Alcohol||
1640|117|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
1640|118|P|use machinery, or do anything that needs alertness or clear||
1640|119|P|vision until you can do it safely. Limit alcoholic beverages.||
1640|120|P|Talk to your doctor if you are using marijuana (cannabis).||
1640|121|P|   Before having surgery, tell your doctor or dentist about all||
1640|122|P|the products you use (including prescription drugs,||
1640|123|P|nonprescription drugs, and herbal products).||
1640|124|P|   During pregnancy, sildenafil should be used only when clearly||
1640|125|P|needed. Since high blood pressure in the lungs is a serious||
1640|126|P|condition that can harm both a pregnant woman and her unborn||
1640|127|P|baby, do not stop taking this medication unless directed by your||
1640|128|P|doctor. If you are planning pregnancy, become pregnant, or think||
1640|129|P|you may be pregnant, discuss with your doctor right away the||
1640|130|P|benefits and risks of using this medication during pregnancy.||
1640|131|P|   This medication passes into breast milk. Consult your doctor||
1640|132|P|before breastfeeding.||
1640|133|B|||
1640|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1640|135|I|medications work or increase your risk for serious side effects.||
1640|136|I|This document does not contain all possible drug interactions.||
1640|137|I|Keep a list of all the products you use (including||
1640|138|I|prescription/nonprescription drugs and herbal products) and share||
1640|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
1640|140|I|the dosage of any medicines without your doctor's approval.||
1640|141|I|   Some products that may interact with this drug are: riociguat,||
1640|142|I|vericiguat.||
1640|143|I|   Sildenafil can cause a serious drop in your blood pressure||
1640|144|I|when used with nitrates. A serious drop in blood pressure can||
1640|145|I|lead to dizziness, fainting, and rarely heart attack or stroke.||
1640|146|I|Do not use sildenafil with any of the following: certain drugs||
1640|147|I|used to treat chest pain/angina (nitrates such as nitroglycerin,||
1640|148|I|isosorbide), recreational drugs called "poppers" containing amyl||
1640|149|I|or butyl nitrite.||
1640|150|I|   If you are also taking an alpha blocker medication (such as||
1640|151|I|doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high||
1640|152|I|blood pressure, your blood pressure may get too low which can||
1640|153|I|lead to dizziness or fainting. Your doctor may adjust your||
1640|154|I|medications to minimize your risk of low blood pressure.||
1640|155|I|   Other medications can affect the removal of sildenafil from||
1640|156|I|your body, which may affect how sildenafil works. Examples||
1640|157|I|include azole antifungals (such as itraconazole, ketoconazole),||
1640|158|I|cobicistat, macrolide antibiotics (such as clarithromycin,||
1640|159|I|erythromycin), mifepristone, HIV protease inhibitors (such as||
1640|160|I|atazanavir, darunavir), rifampin, ritonavir, among others.||
1640|161|I|   Do not take this medication with any other product that||
1640|162|I|contains sildenafil or other similar medications for erectile||
1640|163|I|dysfunction-ED or pulmonary hypertension (such as tadalafil,||
1640|164|I|vardenafil).||
1640|165|B|||
1640|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1640|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1640|168|O|poison control center right away. US residents can call||
1640|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1640|170|O|Symptoms of overdose may include: dizziness, fainting,||
1640|171|O|painful/prolonged erection.||
1640|172|B|||
1640|173|N|NOTES:  Do not share this medication with others.||
1640|174|N|   Lab and/or medical tests (such as eye exams, blood pressure)||
1640|175|N|may be done while you are taking this medication. Keep all||
1640|176|N|medical and lab appointments. Consult your doctor for more||
1640|177|N|details.||
1640|178|B|||
1640|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1640|180|D|remember. If it is near the time of the next dose, skip the||
1640|181|D|missed dose. Take your next dose at the regular time. Do not||
1640|182|D|double the dose to catch up.||
1640|183|B|||
1640|184|R|STORAGE:  Different brands of this medication have different||
1640|185|R|storage needs. Check the product package for instructions on how||
1640|186|R|to store your brand, or ask your pharmacist. Keep all medications||
1640|187|R|away from children and pets.||
1640|188|R|   Do not flush medications down the toilet or pour them into a||
1640|189|R|drain unless instructed to do so. Properly discard this product||
1640|190|R|when it is expired or no longer needed. Consult your pharmacist||
1640|191|R|or local waste disposal company.||
1640|192|B|||
1640|193|A|Information last revised February 2025.||
1640|194|A|Copyright(c) 2025 First Databank, Inc.||
1640|195|B|||
1641|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1641|002|Z|does NOT have all possible information about this product. This||
1641|003|Z|information does not assure that this product is safe, effective,||
1641|004|Z|or appropriate for you. This information is not individual||
1641|005|Z|medical advice and does not substitute for the advice of your||
1641|006|Z|health care professional. Always ask your health care||
1641|007|Z|professional for complete information about this product and your||
1641|008|Z|specific health needs.||
1641|009|B|||
1641|010|T|ELIGLUSTAT - ORAL||
1641|011|F|(EL-i-GLOO-stat)||
1641|012|B|||
1641|013|C|COMMON BRAND NAME(S): Cerdelga||
1641|014|B|||
1641|015|U|USES:  This medication is used for long-term treatment of a||
1641|016|U|certain rare genetic problem (Gaucher's disease). Eliglustat||
1641|017|U|works by decreasing the amount of a certain natural fatty||
1641|018|U|substance (glucosylceramide) that builds up due to this||
1641|019|U|condition. This can improve symptoms of Gaucher's disease, such||
1641|020|U|as bruising, tiredness, pain in the joints/bones, and a swollen||
1641|021|U|liver/spleen.||
1641|022|B|||
1641|023|H|HOW TO USE:  Read the Medication Guide provided by your||
1641|024|H|pharmacist before you start taking eliglustat and each time you||
1641|025|H|get a refill. If you have any questions, ask your doctor or||
1641|026|H|pharmacist.||
1641|027|H|   Take this medication by mouth with or without food as directed||
1641|028|H|by your doctor, usually once or twice daily. The manufacturer||
1641|029|H|directs to swallow the capsules whole, preferably with water, and||
1641|030|H|not to open, crush, or dissolve the capsules before swallowing.||
1641|031|H|However, other similar drugs (immediate-release capsules) can be||
1641|032|H|opened, and the contents may be sprinkled on or mixed in food.||
1641|033|H|Follow your doctor's directions on how to take this medication.||
1641|034|H|If you are also using enzyme replacement treatment (such as||
1641|035|H|imiglucerase, velaglucerase alfa, or taliglucerase alfa), you may||
1641|036|H|take this medication 24 hours after your dose of the enzyme||
1641|037|H|replacement treatment.||
1641|038|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1641|039|H|using this medication unless your doctor or pharmacist says you||
1641|040|H|may do so safely. Grapefruit can increase the chance of side||
1641|041|H|effects with this medicine. Ask your doctor or pharmacist for||
1641|042|H|more details.||
1641|043|H|   The dosage is based on your medical condition, response to||
1641|044|H|treatment, lab tests, and other medications you may be taking. Be||
1641|045|H|sure to tell your doctor and pharmacist about all the products||
1641|046|H|you use (including prescription drugs, nonprescription drugs, and||
1641|047|H|herbal products).||
1641|048|H|   Use this medication regularly to get the most benefit from it.||
1641|049|H|To help you remember, take it at the same time(s) each day.||
1641|050|H|   Tell your doctor if your condition does not get better or if||
1641|051|H|it gets worse.||
1641|052|B|||
1641|053|S|SIDE EFFECTS:  Nausea, upset stomach, abdominal pain,||
1641|054|S|gas/bloating, diarrhea, headache, back pain, arm/leg pain,||
1641|055|S|dizziness, or weakness may occur. If any of these effects last or||
1641|056|S|get worse, tell your doctor or pharmacist promptly.||
1641|057|S|   Remember that this medication has been prescribed because your||
1641|058|S|doctor has judged that the benefit to you is greater than the||
1641|059|S|risk of side effects. Many people using this medication do not||
1641|060|S|have serious side effects.||
1641|061|S|   Get medical help right away if you have any very serious side||
1641|062|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1641|063|S|fainting.||
1641|064|S|   A very serious allergic reaction to this drug is rare.||
1641|065|S|However, get medical help right away if you notice any symptoms||
1641|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1641|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1641|068|S|breathing.||
1641|069|S|   This is not a complete list of possible side effects. If you||
1641|070|S|notice other effects not listed above, contact your doctor or||
1641|071|S|pharmacist.||
1641|072|S|   In the US -||
1641|073|S|   Call your doctor for medical advice about side effects. You||
1641|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1641|075|S|www.fda.gov/medwatch.||
1641|076|S|   In Canada - Call your doctor for medical advice about side||
1641|077|S|effects. You may report side effects to Health Canada at||
1641|078|S|1-866-234-2345.||
1641|079|B|||
1641|080|P|PRECAUTIONS:  Before taking eliglustat, tell your doctor or||
1641|081|P|pharmacist if you are allergic to it; or if you have any other||
1641|082|P|allergies. This product may contain inactive ingredients, which||
1641|083|P|can cause allergic reactions or other problems. Talk to your||
1641|084|P|pharmacist for more details.||
1641|085|P|   Before using this medication, tell your doctor or pharmacist||
1641|086|P|your medical history, especially of: kidney disease, liver||
1641|087|P|problems.||
1641|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1641|089|P|can make you more dizzy. Do not drive, use machinery, or do||
1641|090|P|anything that needs alertness until you can do it safely. Limit||
1641|091|P|alcoholic beverages. Talk to your doctor if you are using||
1641|092|P|marijuana (cannabis).||
1641|093|P|   Eliglustat may cause a condition that affects the heart rhythm||
1641|094|P|(QT prolongation). QT prolongation can rarely cause serious||
1641|095|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1641|096|P|as severe dizziness, fainting) that need medical attention right||
1641|097|P|away.||
1641|098|P|   The risk of QT prolongation may be increased if you have||
1641|099|P|certain medical conditions or are taking other drugs that may||
1641|100|P|cause QT prolongation. Before using eliglustat, tell your doctor||
1641|101|P|or pharmacist of all the drugs you take and if you have any of||
1641|102|P|the following conditions: certain heart problems (heart failure,||
1641|103|P|slow heartbeat, QT prolongation in the EKG), family history of||
1641|104|P|certain heart problems (QT prolongation in the EKG, sudden||
1641|105|P|cardiac death).||
1641|106|P|   Low levels of potassium or magnesium in the blood may also||
1641|107|P|increase your risk of QT prolongation. This risk may increase if||
1641|108|P|you use certain drugs (such as diuretics/"water pills") or if you||
1641|109|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1641|110|P|   Before having surgery, tell your doctor or dentist about all||
1641|111|P|the products you use (including prescription drugs,||
1641|112|P|nonprescription drugs, and herbal products).||
1641|113|P|   During pregnancy, this medication should be used only when||
1641|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
1641|115|P|   It is unknown if this medication passes into breast milk.||
1641|116|P|Because of the possible risk to the infant, breastfeeding is not||
1641|117|P|recommended while using this medication. Consult your doctor||
1641|118|P|before breastfeeding.||
1641|119|B|||
1641|120|I|DRUG INTERACTIONS:  See also How to Use section.||
1641|121|I|   Drug interactions may change how your medications work or||
1641|122|I|increase your risk for serious side effects. This document does||
1641|123|I|not contain all possible drug interactions. Keep a list of all||
1641|124|I|the products you use (including prescription/nonprescription||
1641|125|I|drugs and herbal products) and share it with your doctor and||
1641|126|I|pharmacist. Do not start, stop, or change the dosage of any||
1641|127|I|medicines without your doctor's approval.||
1641|128|I|   Other medications can affect the removal of eliglustat from||
1641|129|I|your body, which may affect how eliglustat works. Examples||
1641|130|I|include azole antifungals (such as fluconazole, ketoconazole),||
1641|131|I|macrolide antibiotics (such as erythromycin, clarithromycin),||
1641|132|I|rifamycins (such as rifabutin, rifampin), paroxetine, ritonavir,||
1641|133|I|St. John's wort, drugs used to treat seizures (such as||
1641|134|I|carbamazepine, phenobarbital, phenytoin), among others.||
1641|135|B|||
1641|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1641|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1641|138|O|poison control center right away. US residents can call||
1641|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1641|140|B|||
1641|141|N|NOTES:  Do not share this medication with others.||
1641|142|N|   Lab and/or medical tests (such as complete blood count,||
1641|143|N|liver/spleen measurements, a certain liver enzyme test-CYP2D6||
1641|144|N|genotype) should be done before you start taking this medication||
1641|145|N|and while you are taking it. Keep all medical and lab||
1641|146|N|appointments. Consult your doctor for more details.||
1641|147|B|||
1641|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1641|149|D|remember. If it is near the time of the next dose, skip the||
1641|150|D|missed dose. Take your next dose at the regular time. Do not||
1641|151|D|double the dose to catch up.||
1641|152|B|||
1641|153|R|STORAGE:  Store at room temperature away from light and moisture.||
1641|154|R|Do not store in the bathroom. Keep all medications away from||
1641|155|R|children and pets.||
1641|156|R|   Do not flush medications down the toilet or pour them into a||
1641|157|R|drain unless instructed to do so. Properly discard this product||
1641|158|R|when it is expired or no longer needed. Consult your pharmacist||
1641|159|R|or local waste disposal company.||
1641|160|B|||
1641|161|A|Information last revised April 2025.||
1641|162|A|Copyright(c) 2025 First Databank, Inc.||
1641|163|B|||
1642|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1642|002|Z|does NOT have all possible information about this product. This||
1642|003|Z|information does not assure that this product is safe, effective,||
1642|004|Z|or appropriate for you. This information is not individual||
1642|005|Z|medical advice and does not substitute for the advice of your||
1642|006|Z|health care professional. Always ask your health care||
1642|007|Z|professional for complete information about this product and your||
1642|008|Z|specific health needs.||
1642|009|B|||
1642|010|T|NALOXEGOL - ORAL||
1642|011|F|(nal-OX-ee-gol)||
1642|012|B|||
1642|013|C|COMMON BRAND NAME(S): Movantik||
1642|014|B|||
1642|015|U|USES:  This medication is used to treat constipation caused by||
1642|016|U|opioid medications in people with ongoing pain that is not caused||
1642|017|U|by cancer. It blocks the effect of opioids on the gut without||
1642|018|U|blocking the effect on pain. Naloxegol belongs to a class of||
1642|019|U|drugs known as opioid antagonists.||
1642|020|B|||
1642|021|H|HOW TO USE:  Read the Medication Guide provided by your||
1642|022|H|pharmacist before you start taking naloxegol and each time you||
1642|023|H|get a refill. If you have any questions, ask your doctor or||
1642|024|H|pharmacist.||
1642|025|H|   Take this medication by mouth on an empty stomach at least 1||
1642|026|H|hour before or 2 hours after a meal, as directed by your doctor,||
1642|027|H|usually once daily in the morning.||
1642|028|H|   If you are unable to swallow this medication whole, you may||
1642|029|H|crush the tablets to a powder, mix in 4 ounces (120 milliliters)||
1642|030|H|of water and drink immediately. Refill the glass with another 4||
1642|031|H|ounces of water, stir the contents and drink it.||
1642|032|H|   If you are giving this medication through a tube into the||
1642|033|H|stomach (nasogastric tube), ask you health care professional for||
1642|034|H|detailed instructions on how to properly mix and give it.||
1642|035|H|   The dosage is based on your medical condition, response to||
1642|036|H|treatment, and other medications you may be taking. Be sure to||
1642|037|H|tell your doctor and pharmacist about all the products you use||
1642|038|H|(including prescription drugs, nonprescription drugs, and herbal||
1642|039|H|products).||
1642|040|H|   Use this medication regularly to get the most benefit from it.||
1642|041|H|To help you remember, take it at the same time each day.||
1642|042|H|   Do not increase your dose or use this drug more often or for||
1642|043|H|longer than prescribed. Your condition will not improve any||
1642|044|H|faster, and your risk of side effects will increase.||
1642|045|H|   Naloxegol is used only for constipation caused by opioids.||
1642|046|H|Stop using this medication when you stop taking opioid pain||
1642|047|H|medication unless otherwise directed by your doctor.||
1642|048|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1642|049|H|using this medication unless your doctor or pharmacist says you||
1642|050|H|may do so safely. Grapefruit can increase the chance of side||
1642|051|H|effects with this medicine. Ask your doctor or pharmacist for||
1642|052|H|more details.||
1642|053|H|   Stop taking other laxatives before you start treatment with||
1642|054|H|naloxegol. Your doctor may direct you to take other laxatives if||
1642|055|H|your condition does not get better after 3 days of treatment with||
1642|056|H|naloxegol. Ask your doctor for more details and follow your||
1642|057|H|doctor's instructions carefully.||
1642|058|H|   Tell your doctor if your constipation lasts or gets worse.||
1642|059|B|||
1642|060|S|SIDE EFFECTS:  Pain in the stomach/abdomen, diarrhea, or gas may||
1642|061|S|occur. If any of these effects last or get worse, tell your||
1642|062|S|doctor or pharmacist promptly.||
1642|063|S|   Remember that this medication has been prescribed because your||
1642|064|S|doctor has judged that the benefit to you is greater than the||
1642|065|S|risk of side effects. Many people using this medication do not||
1642|066|S|have serious side effects.||
1642|067|S|   Opiate withdrawal symptoms may occur in some people. Tell your||
1642|068|S|doctor right away if any of these withdrawal symptoms occur:||
1642|069|S|sweating, chills, pain in the stomach/abdomen, diarrhea, yawning,||
1642|070|S|mental/mood changes (such as anxiety/irritability).||
1642|071|S|   This drug may rarely cause a serious tear in the stomach or||
1642|072|S|intestinal wall (perforation). If you notice any of the following||
1642|073|S|unlikely but serious side effects, get medical help right away:||
1642|074|S|severe stomach/abdominal pain that doesn't go away, fever,||
1642|075|S|dizziness/fainting, nausea/vomiting.||
1642|076|S|   A very serious allergic reaction to this drug is rare.||
1642|077|S|However, get medical help right away if you notice any symptoms||
1642|078|S|of a serious allergic reaction, including: rash, itching/swelling||
1642|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1642|080|S|breathing.||
1642|081|S|   This is not a complete list of possible side effects. If you||
1642|082|S|notice other effects not listed above, contact your doctor or||
1642|083|S|pharmacist.||
1642|084|S|   In the US -||
1642|085|S|   Call your doctor for medical advice about side effects. You||
1642|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1642|087|S|www.fda.gov/medwatch.||
1642|088|S|   In Canada - Call your doctor for medical advice about side||
1642|089|S|effects. You may report side effects to Health Canada at||
1642|090|S|1-866-234-2345.||
1642|091|B|||
1642|092|P|PRECAUTIONS:  Before taking naloxegol, tell your doctor or||
1642|093|P|pharmacist if you are allergic to it; or if you have any other||
1642|094|P|allergies. This product may contain inactive ingredients, which||
1642|095|P|can cause allergic reactions or other problems. Talk to your||
1642|096|P|pharmacist for more details.||
1642|097|P|   Before using this medication, tell your doctor or pharmacist||
1642|098|P|your medical history, especially of: stomach/intestinal blockage,||
1642|099|P|stomach/intestinal ulcers or tumors, bowel disease (such as||
1642|100|P|Crohn's, diverticulitis), kidney disease.||
1642|101|P|   Before having surgery, tell your doctor or dentist about all||
1642|102|P|the products you use (including prescription drugs,||
1642|103|P|nonprescription drugs, and herbal products).||
1642|104|P|   During pregnancy, naloxegol should be used only when clearly||
1642|105|P|needed. This medication may cause opioid withdrawal in a pregnant||
1642|106|P|woman and her unborn baby. Discuss the risks and benefits with||
1642|107|P|your doctor.||
1642|108|P|   It is unknown if this medication passes into breast milk. This||
1642|109|P|medication may cause opioid withdrawal in a nursing infant.||
1642|110|P|Consult your doctor before breastfeeding.||
1642|111|B|||
1642|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1642|113|I|medications work or increase your risk for serious side effects.||
1642|114|I|This document does not contain all possible drug interactions.||
1642|115|I|Keep a list of all the products you use (including||
1642|116|I|prescription/nonprescription drugs and herbal products) and share||
1642|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
1642|118|I|the dosage of any medicines without your doctor's approval.||
1642|119|I|   Other medications can affect the removal of naloxegol from||
1642|120|I|your body, which may affect how naloxegol works. Examples include||
1642|121|I|adagrasib, azole antifungals (such as ketoconazole,||
1642|122|I|itraconazole), clarithromycin, cobicistat, HIV protease||
1642|123|I|inhibitors (such as atazanavir), nefazodone, nelfinavir,||
1642|124|I|rifamycins (such as rifampin, rifabutin), ritonavir, tipranavir,||
1642|125|I|among others.||
1642|126|B|||
1642|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1642|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1642|129|O|poison control center right away. US residents can call||
1642|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1642|131|B|||
1642|132|N|NOTES:  Do not share this medication with others.||
1642|133|B|||
1642|134|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1642|135|D|remember. If it is near the time of the next dose, skip the||
1642|136|D|missed dose. Take your next dose at the regular time. Do not||
1642|137|D|double the dose to catch up.||
1642|138|B|||
1642|139|R|STORAGE:  Store at room temperature away from light and moisture.||
1642|140|R|Do not store in the bathroom. Keep all medications away from||
1642|141|R|children and pets.||
1642|142|R|   Do not flush medications down the toilet or pour them into a||
1642|143|R|drain unless instructed to do so. Properly discard this product||
1642|144|R|when it is expired or no longer needed. Consult your pharmacist||
1642|145|R|or local waste disposal company.||
1642|146|B|||
1642|147|A|Information last revised April 2025.||
1642|148|A|Copyright(c) 2025 First Databank, Inc.||
1642|149|B|||
1643|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1643|002|Z|does NOT have all possible information about this product. This||
1643|003|Z|information does not assure that this product is safe, effective,||
1643|004|Z|or appropriate for you. This information is not individual||
1643|005|Z|medical advice and does not substitute for the advice of your||
1643|006|Z|health care professional. Always ask your health care||
1643|007|Z|professional for complete information about this product and your||
1643|008|Z|specific health needs.||
1643|009|B|||
1643|010|T|PEMBROLIZUMAB - INJECTION||
1643|011|F|(PEM-broe-LIZ-ue-mab)||
1643|012|B|||
1643|013|C|COMMON BRAND NAME(S): Keytruda||
1643|014|B|||
1643|015|U|USES:  Pembrolizumab is used to treat cancer. It works by||
1643|016|U|changing how your immune system works, making it attack cancer||
1643|017|U|cells. Pembrolizumab belongs to a class of drugs known as||
1643|018|U|monoclonal antibodies.||
1643|019|B|||
1643|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1643|021|H|pharmacist before you start receiving pembrolizumab and each time||
1643|022|H|you get a treatment. If you have any questions, ask your doctor||
1643|023|H|or pharmacist.||
1643|024|H|   This medication is given by a health care professional. It is||
1643|025|H|injected slowly into a vein over 30 minutes. It is given as||
1643|026|H|directed by your doctor, usually once every 3 weeks or once every||
1643|027|H|6 weeks. The dosage is based on your medical condition and||
1643|028|H|response to treatment. Children's dosage is also based on weight.||
1643|029|H|   Infusion reactions may happen during the infusion of this||
1643|030|H|drug. Tell your doctor right away if you have any symptoms of||
1643|031|H|infusion reactions such as fever, chills, shaking, flushing,||
1643|032|H|shortness of breath, dizziness, or feeling faint. Your doctor may||
1643|033|H|slow down or stop your treatment for some time.||
1643|034|H|   Use this medication regularly to get the most benefit from it.||
1643|035|H|To help you remember, mark your calendar with a reminder.||
1643|036|B|||
1643|037|S|SIDE EFFECTS:  See also How to Use section.||
1643|038|S|   Tiredness, swelling ankles/feet/hands, itchy skin, nausea,||
1643|039|S|vomiting, abdominal pain, or trouble sleeping may occur. If any||
1643|040|S|of these effects last or get worse, tell your doctor or||
1643|041|S|pharmacist promptly.||
1643|042|S|   People using this medication may have serious side effects.||
1643|043|S|Some of these effects may occur even after stopping treatment.||
1643|044|S|However, you have been prescribed this drug because your doctor||
1643|045|S|has judged that the benefit to you is greater than the risk of||
1643|046|S|side effects. Careful monitoring by your doctor may decrease your||
1643|047|S|risk.||
1643|048|S|   Tell your doctor right away if you have any serious side||
1643|049|S|effects, including: headache that is unusual or doesn't go away,||
1643|050|S|new/worsening cough, shortness of breath, diarrhea with||
1643|051|S|blood/mucus, symptoms of liver disease (such as nausea/vomiting||
1643|052|S|that doesn't stop, loss of appetite, stomach/abdominal pain,||
1643|053|S|yellowing eyes/skin, dark urine), signs of kidney problems (such||
1643|054|S|as change in the amount of urine, pink/bloody urine),||
1643|055|S|dizziness/fainting, vision changes, deepening of the voice, eye||
1643|056|S|redness/pain/sensitivity to light, numbness/tingling of the||
1643|057|S|arms/legs, joint stiffness/pain, muscle weakness/tenderness/pain,||
1643|058|S|signs of infection (such as sore throat that doesn't go away,||
1643|059|S|fever, chills, burning/painful/frequent/urgent urination), easy||
1643|060|S|bruising/bleeding.||
1643|061|S|   Pembrolizumab may cause hormone gland problems (such as||
1643|062|S|thyroid, pituitary, adrenal, pancreas). Your body could make too||
1643|063|S|much or too little hormone. Tell your doctor right away if you||
1643|064|S|have any symptoms such as: cold or heat intolerance, unexplained||
1643|065|S|weight loss/gain, mental/mood changes,||
1643|066|S|slow/fast/pounding/irregular heartbeat, unusual tiredness,||
1643|067|S|constipation.||
1643|068|S|   This medication may rarely make your blood sugar rise, which||
1643|069|S|can cause or worsen diabetes. Tell your doctor right away if you||
1643|070|S|have symptoms of high blood sugar such as increased||
1643|071|S|thirst/urination. If you already have diabetes, check your blood||
1643|072|S|sugar regularly as directed and share the results with your||
1643|073|S|doctor. Your doctor may need to adjust your diabetes medication,||
1643|074|S|exercise program, or diet.||
1643|075|S|   Get medical help right away if you have any very serious side||
1643|076|S|effects, including: chest pain, seizure.||
1643|077|S|   A very serious allergic reaction to this drug is rare.||
1643|078|S|However, get medical help right away if you notice any symptoms||
1643|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1643|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1643|081|S|breathing.||
1643|082|S|   This is not a complete list of possible side effects. If you||
1643|083|S|notice other effects not listed above, contact your doctor or||
1643|084|S|pharmacist.||
1643|085|S|   In the US -||
1643|086|S|   Call your doctor for medical advice about side effects. You||
1643|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1643|088|S|www.fda.gov/medwatch.||
1643|089|S|   In Canada - Call your doctor for medical advice about side||
1643|090|S|effects. You may report side effects to Health Canada at||
1643|091|S|1-866-234-2345.||
1643|092|B|||
1643|093|P|PRECAUTIONS:  Before using pembrolizumab, tell your doctor or||
1643|094|P|pharmacist if you are allergic to it; or if you have any other||
1643|095|P|allergies. This product may contain inactive ingredients, which||
1643|096|P|can cause allergic reactions or other problems. Talk to your||
1643|097|P|pharmacist for more details.||
1643|098|P|   Before using this medication, tell your doctor or pharmacist||
1643|099|P|your medical history, especially of: organ/tissue transplant.||
1643|100|P|   People who receive a donor stem cell transplant after||
1643|101|P|treatment with pembrolizumab may have very serious (possibly||
1643|102|P|fatal) complications. Ask your doctor for more details.||
1643|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1643|104|P|can make you more dizzy. Do not drive, use machinery, or do||
1643|105|P|anything that needs alertness until you can do it safely. Limit||
1643|106|P|alcoholic beverages. Talk to your doctor if you are using||
1643|107|P|marijuana (cannabis).||
1643|108|P|   Before having surgery, tell your doctor or dentist about all||
1643|109|P|the products you use (including prescription drugs,||
1643|110|P|nonprescription drugs, and herbal products).||
1643|111|P|   Tell your doctor if you are pregnant or plan to become||
1643|112|P|pregnant. You should not become pregnant while using||
1643|113|P|pembrolizumab. Pembrolizumab may harm an unborn baby. Ask about||
1643|114|P|reliable forms of birth control while using this medication and||
1643|115|P|for 4 months after the last dose. If you become pregnant, talk to||
1643|116|P|your doctor right away about the risks and benefits of this||
1643|117|P|medication.||
1643|118|P|   It is unknown if this drug passes into breast milk. Because of||
1643|119|P|the possible risk to the infant, breastfeeding is not recommended||
1643|120|P|while using this drug and for 4 months after the last dose.||
1643|121|P|Consult your doctor before breastfeeding.||
1643|122|B|||
1643|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1643|124|I|medications work or increase your risk for serious side effects.||
1643|125|I|This document does not contain all possible drug interactions.||
1643|126|I|Keep a list of all the products you use (including||
1643|127|I|prescription/nonprescription drugs and herbal products) and share||
1643|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
1643|129|I|the dosage of any medicines without your doctor's approval.||
1643|130|B|||
1643|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1643|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1643|133|O|poison control center right away. US residents can call||
1643|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1643|135|B|||
1643|136|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
1643|137|N|function, blood sugar, complete blood count) should be done||
1643|138|N|before and during treatment with this medication. Keep all||
1643|139|N|medical and lab appointments. Consult your doctor for more||
1643|140|N|details.||
1643|141|B|||
1643|142|D|MISSED DOSE:  It is important to get each dose of this medication||
1643|143|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1643|144|D|right away for a new dosing schedule.||
1643|145|B|||
1643|146|R|STORAGE:  Not applicable. This medication is given in a hospital||
1643|147|R|or clinic and will not be stored at home.||
1643|148|B|||
1643|149|A|Information last revised October 2025.||
1643|150|A|Copyright(c) 2025 First Databank, Inc.||
1643|151|B|||
1644|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1644|002|Z|does NOT have all possible information about this product. This||
1644|003|Z|information does not assure that this product is safe, effective,||
1644|004|Z|or appropriate for you. This information is not individual||
1644|005|Z|medical advice and does not substitute for the advice of your||
1644|006|Z|health care professional. Always ask your health care||
1644|007|Z|professional for complete information about this product and your||
1644|008|Z|specific health needs.||
1644|009|B|||
1644|010|T|AMPHETAMINE - ORAL||
1644|011|F|(am-FET-a-meen)||
1644|012|B|||
1644|013|C|COMMON BRAND NAME(S): Evekeo||
1644|014|B|||
1644|015|W|WARNING:  Misuse or abuse of amphetamines may cause serious||
1644|016|W|(possibly fatal) heart and blood pressure problems.||
1644|017|W|Amphetamine-type medications can be habit-forming. Use only as||
1644|018|W|directed. If you use this drug for a long time, you may become||
1644|019|W|dependent on it and may have withdrawal symptoms after stopping||
1644|020|W|the drug. Consult your doctor or pharmacist for more details.||
1644|021|W|(See also How to Use section).||
1644|022|B|||
1644|023|U|USES:  This medication is used to treat attention deficit||
1644|024|U|hyperactivity disorder - ADHD. It works by changing the amounts||
1644|025|U|of certain natural substances in the brain. Amphetamine belongs||
1644|026|U|to a class of drugs known as stimulants. It can help increase||
1644|027|U|your ability to pay attention, stay focused on an activity, and||
1644|028|U|control behavior problems. It may also help you to organize your||
1644|029|U|tasks and improve listening skills.||
1644|030|U|   This medication is also used to treat a certain sleeping||
1644|031|U|disorder (narcolepsy) to help you stay awake during the day. It||
1644|032|U|should not be used to treat tiredness or to hold off sleep in||
1644|033|U|people who do not have a sleep disorder.||
1644|034|U|   Amphetamine may also be used along with a doctor-approved,||
1644|035|U|reduced-calorie diet to help significantly overweight (obese)||
1644|036|U|people lose weight. It should only be used for a short time (a||
1644|037|U|few weeks) in people who have not lost enough weight with other||
1644|038|U|treatments (such as dieting, other drugs, group programs). It may||
1644|039|U|work by decreasing your appetite.||
1644|040|B|||
1644|041|H|HOW TO USE:  Read the Medication Guide provided by your||
1644|042|H|pharmacist before you start using amphetamine and each time you||
1644|043|H|get a refill. If you have any questions, ask your doctor or||
1644|044|H|pharmacist.||
1644|045|H|   Take this medication by mouth with or without food as directed||
1644|046|H|by your doctor, usually 1 to 3 times a day. The first dose is||
1644|047|H|usually taken when you wake up in the morning. If more doses are||
1644|048|H|prescribed, take them as directed by your doctor, usually 4 to 6||
1644|049|H|hours apart.||
1644|050|H|   If you are using this medication for weight loss, take it as||
1644|051|H|directed by your doctor, usually 30 to 60 minutes before each||
1644|052|H|meal.||
1644|053|H|   Use this medication regularly to get the most benefit from it.||
1644|054|H|To help you remember, take it at the same time(s) each day. Do||
1644|055|H|not take this medication late in the evening because it may cause||
1644|056|H|you to have trouble sleeping (insomnia).||
1644|057|H|   If you suddenly stop using this medication, you may have||
1644|058|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
1644|059|H|mental/mood changes such as depression). To help prevent||
1644|060|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1644|061|H|more likely if you have used amphetamine for a long time or in||
1644|062|H|high doses. Tell your doctor or pharmacist right away if you have||
1644|063|H|withdrawal.||
1644|064|H|   When this medication is used for a long time, it may not work||
1644|065|H|as well. Talk with your doctor if this medication stops working||
1644|066|H|well.||
1644|067|H|   Though it helps many people, this medication may sometimes||
1644|068|H|cause addiction. This risk may be higher if you have a substance||
1644|069|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1644|070|H|Take this medication exactly as prescribed to lower the risk of||
1644|071|H|addiction. Ask your doctor or pharmacist for more details.||
1644|072|H|   Tell your doctor if your condition does not get better or if||
1644|073|H|it gets worse.||
1644|074|B|||
1644|075|S|SIDE EFFECTS:  Nausea, stomach upset, diarrhea, dry mouth,||
1644|076|S|headache, nervousness, dizziness, trouble sleeping, loss of||
1644|077|S|appetite, weight loss, irritability, or restlessness may occur.||
1644|078|S|If any of these effects last or get worse, tell your doctor or||
1644|079|S|pharmacist promptly.||
1644|080|S|   Remember that this medication has been prescribed because your||
1644|081|S|doctor has judged that the benefit to you is greater than the||
1644|082|S|risk of side effects. Many people using this medication do not||
1644|083|S|have serious side effects.||
1644|084|S|   This medication may raise your blood pressure. Check your||
1644|085|S|blood pressure regularly and tell your doctor if the results are||
1644|086|S|high.||
1644|087|S|   Tell your doctor right away if you have any serious side||
1644|088|S|effects, including: signs of blood flow problems in the fingers||
1644|089|S|or toes (such as coldness, numbness, pain, or skin color||
1644|090|S|changes), unusual wounds on the fingers or toes,||
1644|091|S|mental/mood/behavior changes (such as agitation, aggression, mood||
1644|092|S|swings, depression, thoughts of suicide, hallucinations, abnormal||
1644|093|S|thoughts/behavior), uncontrolled muscle movements (such as||
1644|094|S|twitching, shaking), outbursts of words/sounds, swelling||
1644|095|S|ankles/feet, extreme tiredness, change in sexual||
1644|096|S|ability/interest, frequent/prolonged erections (in males), vision||
1644|097|S|changes (such as blurred vision).||
1644|098|S|   Get medical help right away if you have any very serious side||
1644|099|S|effects, including: fainting, severe headache,||
1644|100|S|fast/pounding/irregular heartbeat, seizures, symptoms of a heart||
1644|101|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
1644|102|S|unusual sweating), symptoms of a stroke (such as weakness on one||
1644|103|S|side of the body, trouble speaking, sudden vision changes,||
1644|104|S|confusion).||
1644|105|S|   This medication may increase serotonin and rarely cause a very||
1644|106|S|serious condition called serotonin syndrome/toxicity. The risk||
1644|107|S|increases if you are also taking other drugs that increase||
1644|108|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1644|109|S|take (see Drug Interactions section). Get medical help right away||
1644|110|S|if you develop some of the following symptoms: fast heartbeat,||
1644|111|S|hallucinations, loss of coordination, severe dizziness, severe||
1644|112|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1644|113|S|unusual agitation/restlessness.||
1644|114|S|   A very serious allergic reaction to this drug is rare.||
1644|115|S|However, get medical help right away if you notice any symptoms||
1644|116|S|of a serious allergic reaction, including: rash, itching/swelling||
1644|117|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1644|118|S|breathing.||
1644|119|S|   This is not a complete list of possible side effects. If you||
1644|120|S|notice other effects not listed above, contact your doctor or||
1644|121|S|pharmacist.||
1644|122|S|   In the US -||
1644|123|S|   Call your doctor for medical advice about side effects. You||
1644|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1644|125|S|www.fda.gov/medwatch.||
1644|126|S|   In Canada - Call your doctor for medical advice about side||
1644|127|S|effects. You may report side effects to Health Canada at||
1644|128|S|1-866-234-2345.||
1644|129|B|||
1644|130|P|PRECAUTIONS:  Before taking amphetamine, tell your doctor or||
1644|131|P|pharmacist if you are allergic to it; or to other sympathomimetic||
1644|132|P|drugs (such as dextroamphetamine or lisdexamfetamine); or if you||
1644|133|P|have any other allergies. This product may contain inactive||
1644|134|P|ingredients, which can cause allergic reactions or other||
1644|135|P|problems. Talk to your pharmacist for more details.||
1644|136|P|   Before using this medication, tell your doctor or pharmacist||
1644|137|P|your medical history, especially of: blood circulation problems||
1644|138|P|(such as Raynaud's disease), high blood pressure, glaucoma, heart||
1644|139|P|problems (including irregular heartbeat/rhythm, coronary artery||
1644|140|P|disease, heart failure, cardiomyopathy, problems with the heart||
1644|141|P|structure such as valve problems), mental/mood conditions||
1644|142|P|(especially anxiety, tension, agitation), personal/family history||
1644|143|P|of mental/mood disorders (such as bipolar disorder, depression,||
1644|144|P|psychotic disorder, suicidal thoughts), personal or family||
1644|145|P|history of a substance use disorder (such as overuse of or||
1644|146|P|addiction to drugs/alcohol), personal or family history of||
1644|147|P|uncontrolled muscle movements (such as motor tics, Tourette's||
1644|148|P|syndrome), seizures, stroke, overactive thyroid||
1644|149|P|(hyperthyroidism).||
1644|150|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1644|151|P|can make you more dizzy. Do not drive, use machinery, or do||
1644|152|P|anything that needs alertness until you can do it safely. Limit||
1644|153|P|alcoholic beverages. Talk to your doctor if you are using||
1644|154|P|marijuana (cannabis).||
1644|155|P|   Before having surgery, tell your doctor or dentist about all||
1644|156|P|the products you use (including prescription drugs,||
1644|157|P|nonprescription drugs, and herbal products).||
1644|158|P|   Children may be more sensitive to the side effects of this||
1644|159|P|drug, especially weight loss. This medication may slow down a||
1644|160|P|child's growth. The doctor may recommend temporarily stopping the||
1644|161|P|medication from time to time to reduce this risk. Monitor your||
1644|162|P|child's weight and height. Consult your doctor or pharmacist for||
1644|163|P|more details.||
1644|164|P|   Older adults may be more sensitive to the side effects of this||
1644|165|P|drug, especially chest pain, trouble sleeping, or weight loss.||
1644|166|P|   During pregnancy, this medication should be used only when||
1644|167|P|clearly needed. Discuss the risks and benefits with your doctor.||
1644|168|P|Infants born to mothers who are dependent on this medication may||
1644|169|P|be born too soon (premature) and have low birth weight. They may||
1644|170|P|also have withdrawal symptoms. Tell your doctor right away if you||
1644|171|P|notice possible mood changes, agitation, or unusual tiredness in||
1644|172|P|your newborn.||
1644|173|P|   This medication passes into breast milk and may have||
1644|174|P|undesirable effects on a nursing infant. Breastfeeding is not||
1644|175|P|recommended while using this medication. Consult your doctor||
1644|176|P|before breastfeeding.||
1644|177|B|||
1644|178|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1644|179|I|medications work or increase your risk for serious side effects.||
1644|180|I|This document does not contain all possible drug interactions.||
1644|181|I|Keep a list of all the products you use (including||
1644|182|I|prescription/nonprescription drugs and herbal products) and share||
1644|183|I|it with your doctor and pharmacist. Do not start, stop, or change||
1644|184|I|the dosage of any medicines without your doctor's approval.||
1644|185|I|   Taking MAO inhibitors with this medication may cause a serious||
1644|186|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1644|187|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1644|188|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1644|189|I|selegiline, tranylcypromine) during treatment with this||
1644|190|I|medication. Most MAO inhibitors should also not be taken for two||
1644|191|I|weeks before treatment with this medication. Ask your doctor when||
1644|192|I|to start or stop taking this medication.||
1644|193|I|   Some products have ingredients that could raise your heart||
1644|194|I|rate or blood pressure. Tell your pharmacist what products you||
1644|195|I|are using, and ask how to use them safely (especially||
1644|196|I|cough-and-cold products, diet aids, or NSAIDs such as||
1644|197|I|ibuprofen/naproxen).||
1644|198|I|   The risk of serotonin syndrome/toxicity increases if you are||
1644|199|I|also taking other drugs that increase serotonin. Examples include||
1644|200|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
1644|201|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1644|202|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1644|203|I|serotonin syndrome/toxicity may be more likely when you start or||
1644|204|I|increase the dose of these drugs.||
1644|205|I|   Amphetamine is very similar to dextroamphetamine or||
1644|206|I|lisdexamfetamine. Do not use medications containing||
1644|207|I|dextroamphetamine or lisdexamfetamine while using amphetamine.||
1644|208|I|   This medication may interfere with certain medical/lab tests||
1644|209|I|(such as blood and urine steroid levels, brain scan for||
1644|210|I|Parkinson's disease), possibly causing false test results. Make||
1644|211|I|sure lab personnel and all your doctors know you use this drug.||
1644|212|B|||
1644|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1644|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1644|215|O|poison control center right away. US residents can call||
1644|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1644|217|O|Symptoms of overdose may include: headache that is severe or||
1644|218|O|doesn't go away, severe mental/mood changes, seizures, severe||
1644|219|O|restlessness, fast breathing.||
1644|220|B|||
1644|221|N|NOTES:  Do not share this medication with others. Sharing it is||
1644|222|N|against the law.||
1644|223|N|   Lab and/or medical tests (such as blood pressure, pulse,||
1644|224|N|height and weight in children) should be done while you are||
1644|225|N|taking this medication. Keep all medical and lab appointments.||
1644|226|N|Consult your doctor for more details.||
1644|227|B|||
1644|228|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1644|229|D|remember. If it is late in the afternoon or near the time of the||
1644|230|D|next dose, skip the missed dose. Take your next dose at the||
1644|231|D|regular time. Do not double the dose to catch up.||
1644|232|B|||
1644|233|R|STORAGE:  Store at room temperature away from light and moisture.||
1644|234|R|Do not store in the bathroom. Keep all medications away from||
1644|235|R|children and pets.||
1644|236|R|   Do not flush medications down the toilet or pour them into a||
1644|237|R|drain unless instructed to do so. Properly discard this product||
1644|238|R|when it is expired or no longer needed. Consult your pharmacist||
1644|239|R|or local waste disposal company.||
1644|240|B|||
1644|241|A|Information last revised October 2024.||
1644|242|A|Copyright(c) 2025 First Databank, Inc.||
1644|243|B|||
1645|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1645|002|Z|does NOT have all possible information about this product. This||
1645|003|Z|information does not assure that this product is safe, effective,||
1645|004|Z|or appropriate for you. This information is not individual||
1645|005|Z|medical advice and does not substitute for the advice of your||
1645|006|Z|health care professional. Always ask your health care||
1645|007|Z|professional for complete information about this product and your||
1645|008|Z|specific health needs.||
1645|009|B|||
1645|010|T|NALTREXONE/BUPROPION EXTENDED-RELEASE - ORAL||
1645|011|F|(nal-TREX-one/bue-PROE-pee-on)||
1645|012|B|||
1645|013|C|COMMON BRAND NAME(S): Contrave||
1645|014|B|||
1645|015|W|WARNING:  This medication is a combination of bupropion and||
1645|016|W|naltrexone. Bupropion is an antidepressant used to treat a||
1645|017|W|variety of conditions, including depression and other mental/mood||
1645|018|W|disorders. It can also be prescribed to help with smoking||
1645|019|W|cessation or weight loss. Antidepressants can help prevent||
1645|020|W|suicidal thoughts/attempts and provide other important benefits.||
1645|021|W|However, studies have shown that a small number of people||
1645|022|W|(especially people younger than 25) who take antidepressants for||
1645|023|W|any condition may experience worsening depression, other||
1645|024|W|mental/mood symptoms, or suicidal thoughts/attempts. It is very||
1645|025|W|important to talk with the doctor about the risks and benefits of||
1645|026|W|antidepressant medication (especially for people younger than||
1645|027|W|25), even if treatment is not for a mental/mood condition.||
1645|028|W|   Tell the doctor right away if you notice worsening||
1645|029|W|depression/other psychiatric conditions, unusual behavior changes||
1645|030|W|(including possible suicidal thoughts/attempts), or other||
1645|031|W|mental/mood changes (including new/worsening anxiety, panic||
1645|032|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1645|033|W|impulsive actions, severe restlessness, very rapid speech). Be||
1645|034|W|especially watchful for these symptoms when a new antidepressant||
1645|035|W|is started or when the dose is changed.||
1645|036|W|   If you are using naltrexone/bupropion to lose weight, stop||
1645|037|W|taking this medication and tell your doctor right away if you||
1645|038|W|have any of the symptoms listed above. Tell your doctor right||
1645|039|W|away if you have any of these symptoms after stopping treatment.||
1645|040|B|||
1645|041|U|USES:  This medication is used with a doctor-approved exercise,||
1645|042|U|behavior change, and reduced-calorie diet program to help you||
1645|043|U|lose weight. It is used by certain overweight people, such as||
1645|044|U|those who are obese or have weight-related medical problems.||
1645|045|U|Losing weight and keeping it off can lessen the many health risks||
1645|046|U|that come with obesity, including heart disease, diabetes, high||
1645|047|U|blood pressure, and a shorter life.||
1645|048|U|   Naltrexone belongs to a class of drugs known as opiate||
1645|049|U|antagonists. Bupropion is an antidepressant that helps to restore||
1645|050|U|the balance of certain natural substances (dopamine,||
1645|051|U|norepinephrine) in the brain. These two medications work together||
1645|052|U|on separate parts of the brain to reduce appetite and how much||
1645|053|U|you eat.||
1645|054|U|   Most opiates should not be used for 7 to 10 days before||
1645|055|U|starting naltrexone, but some opiate drugs (such as methadone)||
1645|056|U|should not be used for 10 to 14 days before starting naltrexone.||
1645|057|U|Ask your doctor or pharmacist for more details.||
1645|058|U|   Other forms of naltrexone or bupropion are used to treat a||
1645|059|U|variety of conditions including depression, other mental/mood||
1645|060|U|disorders, smoking cessation, addiction to opioid medication, and||
1645|061|U|alcohol abuse. This combination product is not approved for these||
1645|062|U|other uses.||
1645|063|U|   Discuss the risks and benefits of this medication, as well as||
1645|064|U|other ways to lose weight, with your doctor.||
1645|065|B|||
1645|066|H|HOW TO USE:  Read the Medication Guide if available from your||
1645|067|H|pharmacist before you start taking naltrexone/bupropion and each||
1645|068|H|time you get a refill. If you have any questions, ask your doctor||
1645|069|H|or pharmacist.||
1645|070|H|   Take this medication by mouth with a low-fat meal as directed||
1645|071|H|by your doctor, usually twice daily.||
1645|072|H|   You may have trouble sleeping when you start taking this drug.||
1645|073|H|Do not take your evening dose too close to bedtime.||
1645|074|H|   Swallow the tablets whole. Do not crush or chew this||
1645|075|H|medication. Doing so can release all of the drug at once,||
1645|076|H|increasing the risk of side effects such as seizures.||
1645|077|H|   The dosage is based on your medical condition, response to||
1645|078|H|treatment, and other medications you may be taking. Your dose||
1645|079|H|will be slowly increased to lower the risk of seizures and to||
1645|080|H|limit side effects such as sleeplessness, symptoms of withdrawal||
1645|081|H|from opiates, and high blood pressure. Do not increase your dose,||
1645|082|H|take it more often, or stop taking it without your doctor's||
1645|083|H|approval.||
1645|084|H|   Use this medication regularly to get the most benefit from it.||
1645|085|H|To help you remember, take it at the same times each day.||
1645|086|H|   Tell your doctor if you have not lost weight after 16 weeks on||
1645|087|H|this medication.||
1645|088|B|||
1645|089|S|SIDE EFFECTS:  See also Warning, How to Use, and Precautions||
1645|090|S|sections.||
1645|091|S|   Nausea, vomiting, constipation, stomach pain, headache,||
1645|092|S|dizziness, trouble sleeping, increased sweating, flushing, and||
1645|093|S|dry mouth or strange taste in the mouth may occur. If any of||
1645|094|S|these effects last or get worse, tell your doctor or pharmacist||
1645|095|S|promptly.||
1645|096|S|   Remember that this medication has been prescribed because your||
1645|097|S|doctor has judged that the benefit to you is greater than the||
1645|098|S|risk of side effects. Many people using this medication do not||
1645|099|S|have serious side effects.||
1645|100|S|   Tell your doctor right away if you have any serious side||
1645|101|S|effects, including: mental/mood changes (anxiety, agitation,||
1645|102|S|confusion, memory loss), uncontrolled movements (tremor), ringing||
1645|103|S|in the ears, fainting, severe headache, fast/pounding/irregular||
1645|104|S|heartbeat, chest pain.||
1645|105|S|   Get medical help right away if you have any very serious side||
1645|106|S|effects, including: eye pain/swelling/redness, widened pupils,||
1645|107|S|vision changes (such as seeing rainbow around lights at night).||
1645|108|S|   If you have been taking opioid medications regularly, you||
1645|109|S|could have withdrawal symptoms within minutes after taking||
1645|110|S|naltrexone. Tell your doctor right away if you have any of the||
1645|111|S|following symptoms of opioid withdrawal: mental/mood changes||
1645|112|S|(such as anxiety/irritability), fast breathing, yawning,||
1645|113|S|sweating, watering eyes, goose bumps, muscle twitching.||
1645|114|S|   This drug may rarely cause seizures. Get medical help right||
1645|115|S|away if you have a seizure. If you have a seizure while taking||
1645|116|S|bupropion, you should not take this drug again.||
1645|117|S|   Naltrexone may rarely cause serious (possibly fatal) liver||
1645|118|S|disease. The risk is increased when larger doses are used.||
1645|119|S|Discuss the risks and benefits with your doctor. Stop using this||
1645|120|S|medication and tell your doctor right away if you have symptoms||
1645|121|S|of liver damage, including: nausea/vomiting that doesn't stop,||
1645|122|S|loss of appetite, severe stomach/abdominal pain, yellowing||
1645|123|S|eyes/skin, dark urine.||
1645|124|S|   A very serious allergic reaction to this drug is rare.||
1645|125|S|However, get medical help right away if you notice any symptoms||
1645|126|S|of a serious allergic reaction, including: rash, itching/swelling||
1645|127|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1645|128|S|breathing.||
1645|129|S|   This is not a complete list of possible side effects. If you||
1645|130|S|notice other effects not listed above, contact your doctor or||
1645|131|S|pharmacist.||
1645|132|S|   In the US -||
1645|133|S|   Call your doctor for medical advice about side effects. You||
1645|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1645|135|S|www.fda.gov/medwatch.||
1645|136|S|   In Canada - Call your doctor for medical advice about side||
1645|137|S|effects. You may report side effects to Health Canada at||
1645|138|S|1-866-234-2345.||
1645|139|B|||
1645|140|P|PRECAUTIONS:  See also Warning section.||
1645|141|P|   Before taking naltrexone/bupropion, tell your doctor or||
1645|142|P|pharmacist if you are allergic to it; or if you have any other||
1645|143|P|allergies. This product may contain inactive ingredients, which||
1645|144|P|can cause allergic reactions or other problems. Talk to your||
1645|145|P|pharmacist for more details.||
1645|146|P|   Before using this medication, tell your doctor or pharmacist||
1645|147|P|your medical history, especially of: high blood pressure, heart||
1645|148|P|disease (such as heart failure, recent heart attack), mental/mood||
1645|149|P|disorders (such as bipolar disorder/thoughts of suicide),||
1645|150|P|diabetes, current or recent use (in the last 7-14 days) of any||
1645|151|P|type of opioid drug (such as morphine/methadone/buprenorphine),||
1645|152|P|kidney disease, liver disease (such as cirrhosis), high pressure||
1645|153|P|in the eye (glaucoma), use/abuse of drugs/alcohol, seizures or||
1645|154|P|conditions that increase your risk of seizures (including||
1645|155|P|brain/head injury, brain tumors, arteriovenous malformation,||
1645|156|P|eating disorders such as bulimia/anorexia nervosa).||
1645|157|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1645|158|P|can make you more dizzy. Do not drive, use machinery, or do||
1645|159|P|anything that needs alertness until you can do it safely. Avoid||
1645|160|P|alcoholic beverages. Talk to your doctor if you are using||
1645|161|P|marijuana (cannabis). Alcohol may also increase your risk of||
1645|162|P|seizures.||
1645|163|P|   After stopping treatment with this medication, you may be more||
1645|164|P|sensitive to opioids, increasing your risk of possibly||
1645|165|P|life-threatening side effects from opioids (such as decreased||
1645|166|P|breathing, loss of consciousness).||
1645|167|P|   This medication blocks the effects of opiate drugs (including||
1645|168|P|heroin) and similar drugs (opioids). However, large doses of||
1645|169|P|heroin or opioids can overcome this block. Trying to overcome||
1645|170|P|this block is very dangerous and may cause serious injury, loss||
1645|171|P|of consciousness, and death. Follow your doctor's instructions||
1645|172|P|closely.||
1645|173|P|   Do not take this product with any other product that contains||
1645|174|P|bupropion (such as antidepressants or smoking cessation drugs)||
1645|175|P|since large doses of bupropion are more likely to cause seizures.||
1645|176|P|   Before having surgery, tell your doctor or dentist about all||
1645|177|P|the products you use (including prescription drugs,||
1645|178|P|nonprescription drugs, and herbal products).||
1645|179|P|   Older adults may be more sensitive to the side effects of this||
1645|180|P|drug, especially dizziness. Dizziness can increase the risk of||
1645|181|P|falling.||
1645|182|P|   This medication must not be used during pregnancy. Weight loss||
1645|183|P|during pregnancy is not recommended and may harm an unborn baby.||
1645|184|P|If you become pregnant or think you may be pregnant, tell your||
1645|185|P|doctor right away.||
1645|186|P|   This drug passes into breast milk and may have undesirable||
1645|187|P|effects on a nursing infant. Consult your doctor before||
1645|188|P|breastfeeding.||
1645|189|B|||
1645|190|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1645|191|I|medications work or increase your risk for serious side effects.||
1645|192|I|This document does not contain all possible drug interactions.||
1645|193|I|Keep a list of all the products you use (including||
1645|194|I|prescription/nonprescription drugs and herbal products) and share||
1645|195|I|it with your doctor and pharmacist. Do not start, stop, or change||
1645|196|I|the dosage of any medicines without your doctor's approval.||
1645|197|I|   Some products that may interact with this drug include:||
1645|198|I|dextromethorphan, diarrhea medications (such as diphenoxylate),||
1645|199|I|disulfiram, pimozide, opioid pain or cough relievers (such as||
1645|200|I|codeine, hydrocodone), tamoxifen, thioridazine.||
1645|201|I|   Taking MAO inhibitors with this medication may cause a serious||
1645|202|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1645|203|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1645|204|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1645|205|I|selegiline, tranylcypromine) during treatment with this||
1645|206|I|medication. Most MAO inhibitors should also not be taken for two||
1645|207|I|weeks before and after treatment with this medication. Ask your||
1645|208|I|doctor when to start or stop taking this medication.||
1645|209|I|   This medication may interfere with certain medical/lab tests||
1645|210|I|(such as urine tests for amphetamine, opioid drug tests, and||
1645|211|I|brain scan for Parkinson's disease), possibly causing false test||
1645|212|I|results. Make sure lab personnel and all your doctors know you||
1645|213|I|use this drug.||
1645|214|B|||
1645|215|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1645|216|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1645|217|O|poison control center right away. US residents can call||
1645|218|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1645|219|O|Symptoms of overdose may include: seizures, hallucinations,||
1645|220|O|fast/slow/irregular heart rate, loss of consciousness.||
1645|221|B|||
1645|222|N|NOTES:  Do not share this medication with others.||
1645|223|N|   Lab and/or medical tests (such as blood pressure, pulse, liver||
1645|224|N|function, eye exams) should be done while you are taking this||
1645|225|N|medication. Keep all medical and lab appointments. Consult your||
1645|226|N|doctor for more details.||
1645|227|B|||
1645|228|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1645|229|D|next dose at the regular time. Do not double the dose to catch||
1645|230|D|up.||
1645|231|B|||
1645|232|R|STORAGE:  Store at room temperature away from light and moisture.||
1645|233|R|Do not store in the bathroom. Keep all medications away from||
1645|234|R|children and pets.||
1645|235|R|   Do not flush medications down the toilet or pour them into a||
1645|236|R|drain unless instructed to do so. Properly discard this product||
1645|237|R|when it is expired or no longer needed. Consult your pharmacist||
1645|238|R|or local waste disposal company.||
1645|239|B|||
1645|240|A|Information last revised February 2025.||
1645|241|A|Copyright(c) 2025 First Databank, Inc.||
1645|242|B|||
1646|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1646|002|Z|does NOT have all possible information about this product. This||
1646|003|Z|information does not assure that this product is safe, effective,||
1646|004|Z|or appropriate for you. This information is not individual||
1646|005|Z|medical advice and does not substitute for the advice of your||
1646|006|Z|health care professional. Always ask your health care||
1646|007|Z|professional for complete information about this product and your||
1646|008|Z|specific health needs.||
1646|009|B|||
1646|010|T|DULAGLUTIDE - INJECTION||
1646|011|F|(DOO-la-GLOO-tide)||
1646|012|B|||
1646|013|C|COMMON BRAND NAME(S): Trulicity||
1646|014|B|||
1646|015|W|WARNING:  This medication can cause a certain type of thyroid||
1646|016|W|tumor (thyroid C-cell tumors) in rats. It is unknown if this||
1646|017|W|medication can cause similar tumors in humans. Talk with your||
1646|018|W|doctor about the benefits and risks of treatment with this||
1646|019|W|medication. Do not use this medication if you have a certain||
1646|020|W|inherited disease (multiple endocrine neoplasia syndrome type 2||
1646|021|W|or MEN 2) or if you have a personal/family history of a certain||
1646|022|W|type of cancer (medullary thyroid carcinoma). While using this||
1646|023|W|medication, tell your doctor right away if you notice any signs||
1646|024|W|or symptoms of thyroid tumors, including unusual growth or lump||
1646|025|W|in the neck, difficulty swallowing, shortness of breath,||
1646|026|W|unusual/lasting hoarseness.||
1646|027|B|||
1646|028|U|USES:  Dulaglutide is used with a proper diet and exercise||
1646|029|U|program to control high blood sugar in people with type 2||
1646|030|U|diabetes. Controlling high blood sugar helps prevent kidney||
1646|031|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1646|032|U|function problems. This medication is also used to lessen the||
1646|033|U|risk of a major cardiovascular event (such as heart attack or||
1646|034|U|stroke) in people who already have, or are at high risk for||
1646|035|U|heart/blood vessel disease.||
1646|036|U|   Dulaglutide is similar to a natural hormone in your body||
1646|037|U|(incretin). It works by causing insulin release in response to||
1646|038|U|high blood sugar (such as after a meal) and by decreasing the||
1646|039|U|amount of sugar your liver makes.||
1646|040|U|   Dulaglutide is not a substitute for insulin if you need||
1646|041|U|insulin treatment.||
1646|042|B|||
1646|043|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1646|044|H|provided by your pharmacist before you start using dulaglutide||
1646|045|H|and each time you get a refill. Ask your health care professional||
1646|046|H|how to prepare and use this medication. If you have any||
1646|047|H|questions, ask your doctor or pharmacist.||
1646|048|H|   Inject this medication under the skin as directed by your||
1646|049|H|doctor, usually once every 7 days. The injection is given in the||
1646|050|H|thigh, abdomen, or upper arm. It may be used with or without||
1646|051|H|meals. The dosage is based on your medical condition, age, and||
1646|052|H|response to treatment. Your doctor will start you on a low dose||
1646|053|H|first to decrease your risk of stomach/abdominal side effects,||
1646|054|H|and gradually increase your dose. Follow your doctor's||
1646|055|H|instructions carefully.||
1646|056|H|   Before using, check this product for particles or||
1646|057|H|discoloration. If either is present, do not use the liquid.||
1646|058|H|Before injecting each dose, clean the skin you are going to||
1646|059|H|inject into (the injection site) with rubbing alcohol. Change the||
1646|060|H|injection site each time to lessen injury under the skin. To||
1646|061|H|lessen bruising, do not rub the injection site after a shot.||
1646|062|H|Learn how to store and discard medical supplies safely.||
1646|063|H|   If you are also using insulin, give dulaglutide and insulin as||
1646|064|H|separate injections. Do not mix them. You may inject these||
1646|065|H|medications in the same area of the body, but the injection sites||
1646|066|H|should not be next to each other.||
1646|067|H|   Do not share your pen device with another person, even if the||
1646|068|H|needle is changed. You may give other people a serious infection,||
1646|069|H|or get a serious infection from them.||
1646|070|H|   Use this medication regularly to get the most benefit from it.||
1646|071|H|To help you remember, use it on the same day each week. Mark your||
1646|072|H|calendar with a reminder. Carefully follow the medication||
1646|073|H|treatment plan, meal plan, and exercise program your doctor has||
1646|074|H|recommended.||
1646|075|H|   Tell your doctor if your condition does not get better or if||
1646|076|H|it gets worse (your blood sugar is too high or too low).||
1646|077|B|||
1646|078|S|SIDE EFFECTS:  See also Warning section.||
1646|079|S|   Nausea, diarrhea, vomiting, abdominal pain, stomach upset,||
1646|080|S|decreased appetite, tiredness, or weakness may occur. If any of||
1646|081|S|these effects last or get worse, tell your doctor or pharmacist||
1646|082|S|promptly.||
1646|083|S|   Remember that this medication has been prescribed because your||
1646|084|S|doctor has judged that the benefit to you is greater than the||
1646|085|S|risk of side effects. Many people using this medication do not||
1646|086|S|have serious side effects.||
1646|087|S|   Tell your doctor right away if you have any serious side||
1646|088|S|effects, including: slow/irregular heartbeat, signs of kidney||
1646|089|S|problems (such as change in the amount of urine), vision changes.||
1646|090|S|   Vomiting/diarrhea that doesn't stop may result in dehydration||
1646|091|S|and kidney problems. Contact your doctor promptly if you notice||
1646|092|S|any symptoms of dehydration, such as unusual decreased urination,||
1646|093|S|unusual dry mouth/thirst, fast heartbeat, or||
1646|094|S|dizziness/lightheadedness.||
1646|095|S|   Get medical help right away if you have any very serious side||
1646|096|S|effects, including: signs of pancreas or gallbladder disease||
1646|097|S|(such as nausea/vomiting that doesn't stop, severe||
1646|098|S|stomach/abdominal pain).||
1646|099|S|   Dulaglutide does not usually cause low blood sugar||
1646|100|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1646|101|S|prescribed with other diabetes medications, or if you do not get||
1646|102|S|enough calories from food, or if you do unusually heavy exercise.||
1646|103|S|Talk with your doctor or pharmacist about whether the dose of||
1646|104|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1646|105|S|of low blood sugar include sudden sweating, shaking, fast||
1646|106|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1646|107|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1646|108|S|treat low blood sugar. If you don't have these reliable forms of||
1646|109|S|glucose, rapidly raise your blood sugar by eating a quick source||
1646|110|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1646|111|S|juice or non-diet soda. Tell your doctor right away about the||
1646|112|S|reaction and the use of this product. To help prevent low blood||
1646|113|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1646|114|S|Check with your doctor or pharmacist to find out what you should||
1646|115|S|do if you miss a meal.||
1646|116|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1646|117|S|thirst/urination. If these symptoms occur, tell your doctor right||
1646|118|S|away. Your doctor may need to adjust your diabetes medication,||
1646|119|S|exercise program, or diet.||
1646|120|S|   A very serious allergic reaction to this drug is rare.||
1646|121|S|However, get medical help right away if you notice any symptoms||
1646|122|S|of a serious allergic reaction, including: rash, itching/swelling||
1646|123|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1646|124|S|breathing.||
1646|125|S|   This is not a complete list of possible side effects. If you||
1646|126|S|notice other effects not listed above, contact your doctor or||
1646|127|S|pharmacist.||
1646|128|S|   In the US -||
1646|129|S|   Call your doctor for medical advice about side effects. You||
1646|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1646|131|S|www.fda.gov/medwatch.||
1646|132|S|   In Canada - Call your doctor for medical advice about side||
1646|133|S|effects. You may report side effects to Health Canada at||
1646|134|S|1-866-234-2345.||
1646|135|B|||
1646|136|P|PRECAUTIONS:  See also Warning section.||
1646|137|P|   Before using dulaglutide, tell your doctor or pharmacist if||
1646|138|P|you are allergic to it; or if you have any other allergies. This||
1646|139|P|product may contain inactive ingredients, which can cause||
1646|140|P|allergic reactions or other problems. Talk to your pharmacist for||
1646|141|P|more details.||
1646|142|P|   Before using this medication, tell your doctor or pharmacist||
1646|143|P|your medical history, especially of: kidney disease, disease of||
1646|144|P|the pancreas (pancreatitis), gallbladder disease,||
1646|145|P|stomach/intestinal disorders (such as gastroparesis), a certain||
1646|146|P|eye problem (diabetic retinopathy).||
1646|147|P|   You may experience blurred vision, dizziness, or drowsiness||
1646|148|P|due to extremely low or high blood sugar. Do not drive, use||
1646|149|P|machinery, or do anything that needs alertness or clear vision||
1646|150|P|until you can do it safely.||
1646|151|P|   Limit alcohol while taking this medication because it can||
1646|152|P|increase your risk of developing low blood sugar.||
1646|153|P|   It may be harder to control your blood sugar when your body is||
1646|154|P|stressed (such as due to fever, infection, injury, or surgery).||
1646|155|P|Consult your doctor because this may require a change in your||
1646|156|P|treatment plan, medications, or blood sugar testing.||
1646|157|P|   Before having surgery, tell your doctor or dentist about all||
1646|158|P|the products you use (including prescription drugs,||
1646|159|P|nonprescription drugs, and herbal products).||
1646|160|P|   During pregnancy, this medication should be used only when||
1646|161|P|clearly needed. Discuss the risks and benefits with your doctor.||
1646|162|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1646|163|P|your doctor for managing your blood sugar while pregnant. Your||
1646|164|P|doctor may change your diabetes treatment during your pregnancy||
1646|165|P|(such as diet and medications including insulin).||
1646|166|P|   It is unknown if this drug passes into breast milk. Consult||
1646|167|P|your doctor before breastfeeding.||
1646|168|B|||
1646|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1646|170|I|medications work or increase your risk for serious side effects.||
1646|171|I|This document does not contain all possible drug interactions.||
1646|172|I|Keep a list of all the products you use (including||
1646|173|I|prescription/nonprescription drugs and herbal products) and share||
1646|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
1646|175|I|the dosage of any medicines without your doctor's approval.||
1646|176|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1646|177|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1646|178|I|heartbeat you would usually feel when your blood sugar falls too||
1646|179|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1646|180|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1646|181|I|   Many drugs can affect your blood sugar, making it harder to||
1646|182|I|control. Before you start, stop, or change any medication, talk||
1646|183|I|with your doctor or pharmacist about how the medication may||
1646|184|I|affect your blood sugar. Check your blood sugar regularly as||
1646|185|I|directed and share the results with your doctor. Tell your doctor||
1646|186|I|right away if you have symptoms of high or low blood sugar. (See||
1646|187|I|also Side Effects section.) Your doctor may need to adjust your||
1646|188|I|diabetes medication, exercise program, or diet.||
1646|189|B|||
1646|190|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1646|191|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1646|192|O|poison control center right away. US residents can call||
1646|193|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1646|194|B|||
1646|195|N|NOTES:  Do not share this medication with others.||
1646|196|N|   Attend a diabetes education program to learn more about how to||
1646|197|N|manage your diabetes with medications, diet, exercise, and||
1646|198|N|regular medical exams.||
1646|199|N|   Learn the symptoms of high and low blood sugar and how to||
1646|200|N|treat low blood sugar. Check your blood sugar regularly as||
1646|201|N|directed.||
1646|202|N|   Lab and/or medical tests (such as kidney function, fasting||
1646|203|N|blood glucose, hemoglobin A1c, eye exams) should be done while||
1646|204|N|you are using this medication. Keep all medical and lab||
1646|205|N|appointments.||
1646|206|B|||
1646|207|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1646|208|D|If it is within 3 days of the next dose, skip the missed dose.||
1646|209|D|Use your next dose at the regular time. Do not double the dose to||
1646|210|D|catch up.||
1646|211|B|||
1646|212|R|STORAGE:  Store in the refrigerator. Do not freeze. This||
1646|213|R|medication may also be stored at room temperature if needed. If||
1646|214|R|the medication is stored at room temperature, discard after 2||
1646|215|R|weeks. Keep all medications away from children and pets.||
1646|216|R|   Do not flush medications down the toilet or pour them into a||
1646|217|R|drain unless instructed to do so. Properly discard this product||
1646|218|R|when it is expired or no longer needed. Consult your pharmacist||
1646|219|R|or local waste disposal company.||
1646|220|B|||
1646|221|M|MEDICAL ALERT:  Your condition can cause complications in a||
1646|222|M|medical emergency. For information about enrolling in MedicAlert,||
1646|223|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1646|224|B|||
1646|225|A|Information last revised May 2025.||
1646|226|A|Copyright(c) 2025 First Databank, Inc.||
1646|227|B|||
1647|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1647|002|Z|does NOT have all possible information about this product. This||
1647|003|Z|information does not assure that this product is safe, effective,||
1647|004|Z|or appropriate for you. This information is not individual||
1647|005|Z|medical advice and does not substitute for the advice of your||
1647|006|Z|health care professional. Always ask your health care||
1647|007|Z|professional for complete information about this product and your||
1647|008|Z|specific health needs.||
1647|009|B|||
1647|010|T|IMMUNE GLOBULIN/HYALURONIDASE KIT - SUBCUTANEOUS INJECTION||
1647|011|F|(i-MUNE-GLOB-ue-lin/HYE-al-ure-ON-i-dase)||
1647|012|B|||
1647|013|C|COMMON BRAND NAME(S): Hyqvia||
1647|014|B|||
1647|015|W|WARNING:  Immune globulin may rarely cause serious problems from||
1647|016|W|blood clots (such as heart attack, stroke, blood clots in the||
1647|017|W|lungs or legs). You may be at increased risk for blood clots if||
1647|018|W|you are an older adult, are severely dehydrated, have a catheter||
1647|019|W|in a vein close to your heart for giving medications, or have a||
1647|020|W|history of blood clots, heart/blood vessel disease, heart||
1647|021|W|failure, stroke, or if you are immobile (such as on very long||
1647|022|W|plane flights or bedridden). If you use estrogen-containing||
1647|023|W|products, these may also increase your risk. Before using this||
1647|024|W|medication, if you have any of these conditions report them to||
1647|025|W|your doctor or pharmacist.||
1647|026|W|   The risk of blood clots may be decreased by injecting immune||
1647|027|W|globulin more slowly. Drinking enough water before receiving||
1647|028|W|immune globulin may also help reduce this risk.||
1647|029|W|   Get medical help right away if any of these side effects||
1647|030|W|occur: shortness of breath/rapid breathing, chest/jaw/left arm||
1647|031|W|pain, unusual sweating, sudden dizziness/fainting,||
1647|032|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1647|033|W|trouble speaking, weakness on one side of the body, sudden vision||
1647|034|W|changes, or confusion.||
1647|035|B|||
1647|036|U|USES:  This kit contains two medications: immune globulin and||
1647|037|U|hyaluronidase.||
1647|038|U|   Immune globulin is used to boost the body's natural defense||
1647|039|U|system against infection in persons with a weakened immune system||
1647|040|U|(primary immune deficiency). Immune globulin contains natural||
1647|041|U|substances called antibodies (a type called IgG) that come from||
1647|042|U|healthy human blood (plasma). These antibodies help protect your||
1647|043|U|body against infections and help you to fight an infection if you||
1647|044|U|get sick.||
1647|045|U|   Immune globulin is also used to treat a certain nerve disorder||
1647|046|U|(chronic inflammatory demyelinating polyneuropathy-CIDP). This||
1647|047|U|disorder causes weakness and numbness/tingling/pain in the arms||
1647|048|U|and legs. This medication helps to improve these symptoms and||
1647|049|U|prevents relapse.||
1647|050|U|   Hyaluronidase is used to help the body absorb the immune||
1647|051|U|globulin.||
1647|052|B|||
1647|053|H|HOW TO USE:  Read the Patient Information Leaflet and||
1647|054|H|Instructions for Use if available from your pharmacist before you||
1647|055|H|start using immune globulin/hyaluronidase and each time you get a||
1647|056|H|refill. If you have any questions, ask your doctor or pharmacist.||
1647|057|H|   This medication is given slowly by injection (infusion) under||
1647|058|H|the skin in the abdomen or thigh as directed by your doctor,||
1647|059|H|usually every 3 to 4 weeks. Hyaluronidase should be injected||
1647|060|H|first followed by immune globulin. Do not inject this medication||
1647|061|H|into a blood vessel. The dosage is based on your medical||
1647|062|H|condition, weight, and response to treatment.||
1647|063|H|   To reduce your risk of side effects, your doctor may direct||
1647|064|H|you to start this medication at a low dose and gradually increase||
1647|065|H|your dose and dosing interval. Follow your doctor's instructions||
1647|066|H|carefully.||
1647|067|H|   If you are using this medication at home, learn all||
1647|068|H|preparation and usage instructions from your health care||
1647|069|H|professional and the product package.||
1647|070|H|   Let the medication vials come to room temperature before use.||
1647|071|H|Do not shake the vials. Before using, check this product for||
1647|072|H|particles or discoloration. If either is present, do not use the||
1647|073|H|liquid. Before injecting each dose, clean the skin you are going||
1647|074|H|to inject into (the injection site) with rubbing alcohol. Change||
1647|075|H|the injection site(s) each time to lessen injury under the skin.||
1647|076|H|Do not inject into bony areas or into skin that is infected,||
1647|077|H|scarred or swollen. To lessen bruising, do not rub the injection||
1647|078|H|site after each dose. Learn how to store and discard medical||
1647|079|H|supplies safely.||
1647|080|H|   Use this medication regularly to get the most benefit from it.||
1647|081|H|To help you remember, mark your calendar with a reminder.||
1647|082|B|||
1647|083|S|SIDE EFFECTS:  See also Warning section.||
1647|084|S|   Redness, warmth, pain, swelling, or itching at the injection||
1647|085|S|site may occur. Headache may also occur. If any of these effects||
1647|086|S|last or get worse, tell your doctor or pharmacist promptly.||
1647|087|S|   Remember that this medication has been prescribed because your||
1647|088|S|doctor has judged that the benefit to you is greater than the||
1647|089|S|risk of side effects. Many people using this medication do not||
1647|090|S|have serious side effects.||
1647|091|S|   Tell your doctor right away if you have any serious side||
1647|092|S|effects, including: fast heartbeat, unusual tiredness, yellowing||
1647|093|S|eyes/skin, dark urine, signs of kidney problems (such as change||
1647|094|S|in the amount of urine).||
1647|095|S|   Treatment with this medication may rarely cause a serious||
1647|096|S|swelling of the brain (aseptic meningitis syndrome) several hours||
1647|097|S|to 2 days after your treatment. Get medical help right away if||
1647|098|S|you have severe headache, stiff neck, drowsiness, fever,||
1647|099|S|sensitivity to light, eye pain, or nausea/vomiting.||
1647|100|S|   Lung problems may rarely occur 1 to 6 hours after your||
1647|101|S|treatment. Get medical help right away if you have trouble||
1647|102|S|breathing, chest pain, blue lips/skin, or fever.||
1647|103|S|   A very serious allergic reaction to this drug is rare.||
1647|104|S|However, get medical help right away if you notice any symptoms||
1647|105|S|of a serious allergic reaction, including: rash, itching/swelling||
1647|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1647|107|S|breathing.||
1647|108|S|   This is not a complete list of possible side effects. If you||
1647|109|S|notice other effects not listed above, contact your doctor or||
1647|110|S|pharmacist.||
1647|111|S|   In the US -||
1647|112|S|   Call your doctor for medical advice about side effects. You||
1647|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1647|114|S|www.fda.gov/medwatch.||
1647|115|S|   In Canada - Call your doctor for medical advice about side||
1647|116|S|effects. You may report side effects to Health Canada at||
1647|117|S|1-866-234-2345.||
1647|118|B|||
1647|119|P|PRECAUTIONS:  See also Warning section.||
1647|120|P|   Before using immune globulin/hyaluronidase, tell your doctor||
1647|121|P|or pharmacist if you are allergic to it; or to other immune||
1647|122|P|globulin products; or if you have any other allergies. This||
1647|123|P|product may contain inactive ingredients, which can cause||
1647|124|P|allergic reactions or other problems. Talk to your pharmacist for||
1647|125|P|more details.||
1647|126|P|   Before using this medication, tell your doctor or pharmacist||
1647|127|P|your medical history, especially of: a certain type of immune||
1647|128|P|system deficiency (selective IgA deficiency with known antibody||
1647|129|P|against IgA), kidney disease, diabetes, severe loss of body||
1647|130|P|fluids (dehydration), a certain blood problem (paraproteinemia).||
1647|131|P|   Tell your doctor of any recent or planned||
1647|132|P|immunizations/vaccinations. This medication may prevent a good||
1647|133|P|response to certain live viral vaccines (such as measles, mumps,||
1647|134|P|rubella, varicella). If you have recently received any of these||
1647|135|P|vaccines, your doctor may have you tested for a response or have||
1647|136|P|you vaccinated again later. If you plan on getting any of these||
1647|137|P|vaccines, your doctor will instruct you about the best time to||
1647|138|P|receive them so you get a good response. Also tell your doctor if||
1647|139|P|you plan to travel to areas that have a measles outbreak or if||
1647|140|P|you have been exposed to measles.||
1647|141|P|   Before having surgery, tell your doctor or dentist about all||
1647|142|P|the products you use (including prescription drugs,||
1647|143|P|nonprescription drugs, and herbal products).||
1647|144|P|   This medication is made from human blood. Even though the||
1647|145|P|blood is carefully tested, and this medication goes through a||
1647|146|P|special manufacturing process, there is an extremely small chance||
1647|147|P|that you may get infections from the medication (for example,||
1647|148|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
1647|149|P|more information.||
1647|150|P|   During pregnancy, this medication should be used only when||
1647|151|P|clearly needed. Discuss the risks and benefits with your doctor.||
1647|152|P|   It is unknown if this medication passes into breast milk.||
1647|153|P|Consult your doctor before breastfeeding.||
1647|154|B|||
1647|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1647|156|I|medications work or increase your risk for serious side effects.||
1647|157|I|This document does not contain all possible drug interactions.||
1647|158|I|Keep a list of all the products you use (including||
1647|159|I|prescription/nonprescription drugs and herbal products) and share||
1647|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
1647|161|I|the dosage of any medicines without your doctor's approval.||
1647|162|I|   This medication may interfere with certain lab tests (such as||
1647|163|I|blood type), possibly causing false test results. Make sure lab||
1647|164|I|personnel and all your doctors know you use this drug.||
1647|165|B|||
1647|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1647|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1647|168|O|poison control center right away. US residents can call||
1647|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1647|170|B|||
1647|171|N|NOTES:  Do not share this medication with others.||
1647|172|N|   Lab tests (such as IgG levels, kidney function) should be done||
1647|173|N|while you are using this medication. Keep all medical and lab||
1647|174|N|appointments. Consult your doctor for more details.||
1647|175|B|||
1647|176|D|MISSED DOSE:  It is important to get each dose of this medication||
1647|177|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1647|178|D|right away for a new dosing schedule.||
1647|179|B|||
1647|180|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1647|181|R|medication in the original carton to protect from light.||
1647|182|R|Depending on the manufacturing date, this medication may also be||
1647|183|R|stored at room temperature for up to 3 months if needed. Refer to||
1647|184|R|the manufacturer's instructions or your pharmacist for other||
1647|185|R|storage details. If the medication is stored at room temperature,||
1647|186|R|do not put it back in the refrigerator. Keep all medications away||
1647|187|R|from children and pets.||
1647|188|R|   Do not flush medications down the toilet or pour them into a||
1647|189|R|drain unless instructed to do so. Properly discard this product||
1647|190|R|when it is expired or no longer needed. Consult your pharmacist||
1647|191|R|or local waste disposal company.||
1647|192|B|||
1647|193|A|Information last revised June 2025.||
1647|194|A|Copyright(c) 2025 First Databank, Inc.||
1647|195|B|||
1648|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1648|002|Z|does NOT have all possible information about this product. This||
1648|003|Z|information does not assure that this product is safe, effective,||
1648|004|Z|or appropriate for you. This information is not individual||
1648|005|Z|medical advice and does not substitute for the advice of your||
1648|006|Z|health care professional. Always ask your health care||
1648|007|Z|professional for complete information about this product and your||
1648|008|Z|specific health needs.||
1648|009|B|||
1648|010|T|FERRIC CITRATE - ORAL||
1648|011|F|(FER-us SI-trate)||
1648|012|B|||
1648|013|C|COMMON BRAND NAME(S): Auryxia, Ferric Citrate||
1648|014|B|||
1648|015|W|WARNING:  Accidental overdose of iron-containing products is a||
1648|016|W|leading cause of fatal poisoning in children younger than 6||
1648|017|W|years. Keep this product out of reach of children. If overdose||
1648|018|W|does occur, get medical help right away or call a poison control||
1648|019|W|center.||
1648|020|B|||
1648|021|U|USES:  Ferric citrate is used to lower high blood phosphate||
1648|022|U|levels in people who are on dialysis due to severe kidney||
1648|023|U|disease. Dialysis removes some phosphate from your blood, but it||
1648|024|U|is difficult to remove enough to keep your phosphate levels||
1648|025|U|balanced. Decreasing blood phosphate levels can help keep your||
1648|026|U|bones strong, prevent unsafe buildup of minerals in your body,||
1648|027|U|and may decrease the risk of heart disease and strokes that can||
1648|028|U|result from high phosphate levels. This medication works by||
1648|029|U|binding to phosphate in the foods you eat. The phosphate then||
1648|030|U|passes out of your body in your stool.||
1648|031|U|   Ferric citrate is a form of iron. This medication is also used||
1648|032|U|to treat low blood levels of iron (anemia) in people with||
1648|033|U|long-term kidney disease who are not on dialysis. Iron is an||
1648|034|U|important mineral that your body needs to produce red blood cells||
1648|035|U|and keep you in good health.||
1648|036|B|||
1648|037|H|HOW TO USE:  See also Drug Interactions section.||
1648|038|H|   Take this medication by mouth, usually 3 times daily with a||
1648|039|H|meal and some fluids as directed by your doctor. Do not lie down||
1648|040|H|for at least 10 minutes after taking your dose.||
1648|041|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1648|042|H|Crushing or chewing the tablets may cause your mouth or teeth to||
1648|043|H|change color.||
1648|044|H|   Take this medication regularly to get the most benefit from||
1648|045|H|it. The dosage is based on your medical condition, response to||
1648|046|H|treatment, and lab test results. Do not take more of this||
1648|047|H|medication than prescribed.||
1648|048|B|||
1648|049|S|SIDE EFFECTS:  Nausea, diarrhea, constipation, or vomiting may||
1648|050|S|occur. If any of these effects last or get worse, tell your||
1648|051|S|doctor or pharmacist promptly.||
1648|052|S|   The iron in this medication may cause your stools to turn||
1648|053|S|black. This effect is harmless.||
1648|054|S|   Remember that this medication has been prescribed because your||
1648|055|S|doctor has judged that the benefit to you is greater than the||
1648|056|S|risk of side effects. Many people using this medication do not||
1648|057|S|have serious side effects.||
1648|058|S|   A very serious allergic reaction to this drug is rare.||
1648|059|S|However, get medical help right away if you notice any symptoms||
1648|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1648|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1648|062|S|breathing.||
1648|063|S|   This is not a complete list of possible side effects. If you||
1648|064|S|notice other effects not listed above, contact your doctor or||
1648|065|S|pharmacist.||
1648|066|S|   In the US -||
1648|067|S|   Call your doctor for medical advice about side effects. You||
1648|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1648|069|S|www.fda.gov/medwatch.||
1648|070|S|   In Canada - Call your doctor for medical advice about side||
1648|071|S|effects. You may report side effects to Health Canada at||
1648|072|S|1-866-234-2345.||
1648|073|B|||
1648|074|P|PRECAUTIONS:  Before taking ferric citrate, tell your doctor or||
1648|075|P|pharmacist if you are allergic to it; or if you have any other||
1648|076|P|allergies. This product may contain inactive ingredients, which||
1648|077|P|can cause allergic reactions or other problems. Talk to your||
1648|078|P|pharmacist for more details.||
1648|079|P|   Before using this medication, tell your doctor or pharmacist||
1648|080|P|your medical history, especially of: stomach/intestinal problems||
1648|081|P|(such as ulcers, bleeding), high level of iron in the blood.||
1648|082|P|   Before having surgery, tell your doctor or dentist about all||
1648|083|P|the products you use (including prescription drugs,||
1648|084|P|nonprescription drugs, and herbal products).||
1648|085|P|   During pregnancy, this medication should be used only when||
1648|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
1648|087|P|   It is unknown if this medication passes into breast milk.||
1648|088|P|Consult your doctor before breastfeeding.||
1648|089|B|||
1648|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1648|091|I|medications work or increase your risk for serious side effects.||
1648|092|I|This document does not contain all possible drug interactions.||
1648|093|I|Keep a list of all the products you use (including||
1648|094|I|prescription/nonprescription drugs and herbal products) and share||
1648|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
1648|096|I|the dosage of any medicines without your doctor's approval.||
1648|097|I|   This product can make it hard for your body to absorb many||
1648|098|I|other drugs, including bisphosphonates (such as alendronate),||
1648|099|I|certain quinolone antibiotics (such as ciprofloxacin), thyroid||
1648|100|I|medications (such as levothyroxine), tetracycline antibiotics||
1648|101|I|(such as doxycycline), among others. Separate your doses of these||
1648|102|I|medications as far as possible from your doses of ferric citrate.||
1648|103|I|Ask your doctor or pharmacist about how long you should wait||
1648|104|I|between doses and for help finding a dosing schedule that will||
1648|105|I|work with all your medications.||
1648|106|B|||
1648|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1648|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1648|109|O|poison control center right away. US residents can call||
1648|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1648|111|B|||
1648|112|N|NOTES:  Your doctor may tell you to follow a special diet to help||
1648|113|N|lower your blood phosphate levels. Follow the diet closely.||
1648|114|N|   Do not share this medication with others.||
1648|115|N|   Lab and/or medical tests (such as phosphate and iron blood||
1648|116|N|levels) should be done while you are taking this medication. Keep||
1648|117|N|all medical and lab appointments. Consult your doctor for more||
1648|118|N|details.||
1648|119|B|||
1648|120|D|MISSED DOSE:  If you miss a dose, skip the missed dose unless you||
1648|121|D|have just eaten. If it is near the time of the next dose, skip||
1648|122|D|the missed dose. Take your next dose at the regular time. Do not||
1648|123|D|double the dose to catch up.||
1648|124|B|||
1648|125|R|STORAGE:  Store at room temperature away from light and moisture.||
1648|126|R|Do not store in the bathroom. Keep all medications away from||
1648|127|R|children and pets.||
1648|128|R|   Do not flush medications down the toilet or pour them into a||
1648|129|R|drain unless instructed to do so. Properly discard this product||
1648|130|R|when it is expired or no longer needed. Consult your pharmacist||
1648|131|R|or local waste disposal company.||
1648|132|B|||
1648|133|A|Information last revised May 2024.||
1648|134|A|Copyright(c) 2025 First Databank, Inc.||
1648|135|B|||
1649|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1649|002|Z|does NOT have all possible information about this product. This||
1649|003|Z|information does not assure that this product is safe, effective,||
1649|004|Z|or appropriate for you. This information is not individual||
1649|005|Z|medical advice and does not substitute for the advice of your||
1649|006|Z|health care professional. Always ask your health care||
1649|007|Z|professional for complete information about this product and your||
1649|008|Z|specific health needs.||
1649|009|B|||
1649|010|T|NETUPITANT/PALONOSETRON - ORAL||
1649|011|F|(net-UE-pi-tant/PAL-oh-NOE-se-tron)||
1649|012|B|||
1649|013|C|COMMON BRAND NAME(S): Akynzeo||
1649|014|B|||
1649|015|U|USES:  This product contains 2 medications: netupitant and||
1649|016|U|palonosetron. It is used to prevent nausea and vomiting caused by||
1649|017|U|cancer drug treatment (chemotherapy). Netupitant and palonosetron||
1649|018|U|work by blocking natural substances in the body (such as||
1649|019|U|substance P/neurokinin 1, serotonin) that cause vomiting.||
1649|020|B|||
1649|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1649|022|H|from your pharmacist before you start taking||
1649|023|H|netupitant/palonosetron and each time you get a refill. If you||
1649|024|H|have any questions, ask your doctor or pharmacist.||
1649|025|H|   Take this medication by mouth with or without food as directed||
1649|026|H|by your doctor, usually 1 hour before the start of chemotherapy.||
1649|027|H|   Tell your doctor if you vomit or feel nauseated.||
1649|028|B|||
1649|029|S|SIDE EFFECTS:  Headache may occur. If this effect lasts or gets||
1649|030|S|worse, tell your doctor or pharmacist promptly.||
1649|031|S|   Remember that this medication has been prescribed because your||
1649|032|S|doctor has judged that the benefit to you is greater than the||
1649|033|S|risk of side effects. Many people using this medication do not||
1649|034|S|have serious side effects.||
1649|035|S|   One of the medications in this product (palonosetron) may||
1649|036|S|increase serotonin and rarely cause a very serious condition||
1649|037|S|called serotonin syndrome/toxicity. The risk increases if you are||
1649|038|S|also taking other drugs that increase serotonin, so tell your||
1649|039|S|doctor or pharmacist of all the drugs you take (see Drug||
1649|040|S|Interactions section). Get medical help right away if you develop||
1649|041|S|some of the following symptoms: fast heartbeat, hallucinations,||
1649|042|S|loss of coordination, severe dizziness, severe||
1649|043|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1649|044|S|unusual agitation/restlessness.||
1649|045|S|   A very serious allergic reaction to this drug is rare.||
1649|046|S|However, get medical help right away if you notice any symptoms||
1649|047|S|of a serious allergic reaction, including: rash, itching/swelling||
1649|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1649|049|S|breathing.||
1649|050|S|   This is not a complete list of possible side effects. If you||
1649|051|S|notice other effects not listed above, contact your doctor or||
1649|052|S|pharmacist.||
1649|053|S|   In the US -||
1649|054|S|   Call your doctor for medical advice about side effects. You||
1649|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1649|056|S|www.fda.gov/medwatch.||
1649|057|S|   In Canada - Call your doctor for medical advice about side||
1649|058|S|effects. You may report side effects to Health Canada at||
1649|059|S|1-866-234-2345.||
1649|060|B|||
1649|061|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1649|062|P|pharmacist if you are allergic to netupitant or to palonosetron;||
1649|063|P|or to other anti-nausea serotonin blockers (such as ondansetron);||
1649|064|P|or if you have any other allergies. This product may contain||
1649|065|P|inactive ingredients, which can cause allergic reactions or other||
1649|066|P|problems. Talk to your pharmacist for more details.||
1649|067|P|   Before using this medication, tell your doctor or pharmacist||
1649|068|P|your medical history, especially of: kidney disease, liver||
1649|069|P|disease.||
1649|070|P|   Before having surgery, tell your doctor or dentist about all||
1649|071|P|the products you use (including prescription drugs,||
1649|072|P|nonprescription drugs, and herbal products).||
1649|073|P|   During pregnancy, this medication should be used only when||
1649|074|P|clearly needed. Discuss the risks and benefits with your doctor.||
1649|075|P|   It is unknown if this product passes into breast milk. Consult||
1649|076|P|your doctor before breastfeeding.||
1649|077|B|||
1649|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1649|079|I|medications work or increase your risk for serious side effects.||
1649|080|I|This document does not contain all possible drug interactions.||
1649|081|I|Keep a list of all the products you use (including||
1649|082|I|prescription/nonprescription drugs and herbal products) and share||
1649|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
1649|084|I|the dosage of any medicines without your doctor's approval.||
1649|085|I|   This medication can slow down the removal of other medications||
1649|086|I|from your body, which may affect how they work. Examples of||
1649|087|I|affected drugs include elacestrant, flibanserin, lomitapide,||
1649|088|I|among others.||
1649|089|I|   Other medications can affect the removal of this product from||
1649|090|I|your body, which may affect how it works. Examples include||
1649|091|I|rifamycins (such as rifampin), St. John's wort, among others.||
1649|092|I|   The risk of serotonin syndrome/toxicity increases if you are||
1649|093|I|also taking other drugs that increase serotonin. Examples include||
1649|094|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1649|095|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1649|096|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1649|097|I|serotonin syndrome/toxicity may be more likely when you start or||
1649|098|I|increase the dose of these drugs.||
1649|099|B|||
1649|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1649|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1649|102|O|poison control center right away. US residents can call||
1649|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1649|104|B|||
1649|105|N|NOTES:  Do not share this medication with others.||
1649|106|B|||
1649|107|D|MISSED DOSE:  It is important to take each dose of this||
1649|108|D|medication as scheduled. If you miss a dose, ask your doctor or||
1649|109|D|pharmacist right away for a new dosing schedule. Do not double||
1649|110|D|the dose to catch up.||
1649|111|B|||
1649|112|R|STORAGE:  Store at room temperature away from light and moisture.||
1649|113|R|Do not store in the bathroom. Keep all medications away from||
1649|114|R|children and pets.||
1649|115|R|   Do not flush medications down the toilet or pour them into a||
1649|116|R|drain unless instructed to do so. Properly discard this product||
1649|117|R|when it is expired or no longer needed. Consult your pharmacist||
1649|118|R|or local waste disposal company.||
1649|119|B|||
1649|120|A|Information last revised May 2024.||
1649|121|A|Copyright(c) 2025 First Databank, Inc.||
1649|122|B|||
1650|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1650|002|Z|does NOT have all possible information about this product. This||
1650|003|Z|information does not assure that this product is safe, effective,||
1650|004|Z|or appropriate for you. This information is not individual||
1650|005|Z|medical advice and does not substitute for the advice of your||
1650|006|Z|health care professional. Always ask your health care||
1650|007|Z|professional for complete information about this product and your||
1650|008|Z|specific health needs.||
1650|009|B|||
1650|010|T|PEGINTERFERON BETA 1A - SUBCUTANEOUS INJECTION||
1650|011|F|(peg-IN-ter-FEER-on BAY-ta wun ay)||
1650|012|B|||
1650|013|C|COMMON BRAND NAME(S): Plegridy||
1650|014|B|||
1650|015|U|USES:  This medication is used to treat multiple sclerosis (MS).||
1650|016|U|Peginterferon is not a cure for MS, but it may help to decrease||
1650|017|U|the number of episodes of disease worsening (relapses) and slow||
1650|018|U|the worsening of the disease.||
1650|019|B|||
1650|020|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1650|021|H|provided by your pharmacist before you start using peginterferon||
1650|022|H|and each time you get a refill. Ask your health care professional||
1650|023|H|how to prepare and use this medication. If you have any||
1650|024|H|questions, ask your doctor or pharmacist.||
1650|025|H|   Inject this medication under the skin as directed by your||
1650|026|H|doctor, usually every 14 days. The injection is given in the||
1650|027|H|thigh, abdomen, or the back of the upper arm. Check the injection||
1650|028|H|site 2 hours after injecting to see if there is any reaction at||
1650|029|H|the injection site. Tell the doctor of any skin reactions that do||
1650|030|H|not go away after a few days.||
1650|031|H|   To reduce your risk of side effects, your doctor may direct||
1650|032|H|you to start this medication at a low dose and gradually increase||
1650|033|H|your dose. A starter pack with different doses of this medication||
1650|034|H|may be used when starting this medication. Follow your doctor's||
1650|035|H|instructions carefully.||
1650|036|H|   Take the medication out of the refrigerator at least 30||
1650|037|H|minutes before you inject it to allow it to reach room||
1650|038|H|temperature. Do not warm up this medication any other way (for||
1650|039|H|example, place it in hot water). Before using, check this product||
1650|040|H|for particles or discoloration. If either is present, do not use||
1650|041|H|the liquid. Before injecting each dose, clean the skin you are||
1650|042|H|going to inject into (the injection site) with rubbing alcohol.||
1650|043|H|Change the injection site each time to lessen injury under the||
1650|044|H|skin. Do not inject into skin that is irritated, bruised,||
1650|045|H|scarred, or infected. To lessen bruising, do not rub the||
1650|046|H|injection site after a shot. Learn how to store and discard||
1650|047|H|medical supplies safely.||
1650|048|H|   Use this medication regularly to get the most benefit from it.||
1650|049|H|To help you remember, use it at the same time and same day of the||
1650|050|H|week.||
1650|051|H|   You may need to take other medications to reduce common side||
1650|052|H|effects such as fever and pain (such as acetaminophen,||
1650|053|H|ibuprofen). Consult your doctor or pharmacist about how to use||
1650|054|H|these medications safely with peginterferon.||
1650|055|H|   Tell your doctor if your condition gets worse.||
1650|056|B|||
1650|057|S|SIDE EFFECTS:  Pain, redness, itching, or swelling at the||
1650|058|S|injection site may occur. If any of these effects last or get||
1650|059|S|worse, tell your doctor or pharmacist promptly.||
1650|060|S|   Flu-like symptoms (such as headache, fever, chills, weakness,||
1650|061|S|nausea/vomiting, muscle aches/pain) may also occur, especially||
1650|062|S|when you first start this medication. You can reduce these side||
1650|063|S|effects by using fever reducers/pain relievers such as||
1650|064|S|acetaminophen or ibuprofen. Consult your doctor or pharmacist for||
1650|065|S|more information.||
1650|066|S|   Remember that this medication has been prescribed because your||
1650|067|S|doctor has judged that the benefit to you is greater than the||
1650|068|S|risk of side effects. Many people using this medication do not||
1650|069|S|have serious side effects.||
1650|070|S|   Tell your doctor right away if you have any serious side||
1650|071|S|effects, including: mental/mood changes (such as depression, rare||
1650|072|S|thoughts of suicide), symptoms of liver disease (such as||
1650|073|S|nausea/vomiting that doesn't stop, loss of appetite,||
1650|074|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), pus or||
1650|075|S|change in skin color (blue-black) at the injection site, signs of||
1650|076|S|infection (such as sore throat that doesn't go away, fever,||
1650|077|S|chills), easy bruising/bleeding, fast/slow/irregular heartbeat,||
1650|078|S|new or worsening symptoms of heart failure (such as shortness of||
1650|079|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
1650|080|S|weight gain), intolerance to cold or heat, signs of kidney||
1650|081|S|problems (such as a change in the amount of urine).||
1650|082|S|   Get medical help right away if you have any very serious side||
1650|083|S|effects, including: seizures, chest pain.||
1650|084|S|   A very serious allergic reaction to this drug is rare.||
1650|085|S|However, get medical help right away if you notice any symptoms||
1650|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1650|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1650|088|S|breathing.||
1650|089|S|   This is not a complete list of possible side effects. If you||
1650|090|S|notice other effects not listed above, contact your doctor or||
1650|091|S|pharmacist.||
1650|092|S|   In the US -||
1650|093|S|   Call your doctor for medical advice about side effects. You||
1650|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1650|095|S|www.fda.gov/medwatch.||
1650|096|S|   In Canada - Call your doctor for medical advice about side||
1650|097|S|effects. You may report side effects to Health Canada at||
1650|098|S|1-866-234-2345.||
1650|099|B|||
1650|100|P|PRECAUTIONS:  Before using peginterferon, tell your doctor or||
1650|101|P|pharmacist if you are allergic to it; or to interferon; or if you||
1650|102|P|have any other allergies. This product may contain inactive||
1650|103|P|ingredients, which can cause allergic reactions or other||
1650|104|P|problems. Talk to your pharmacist for more details.||
1650|105|P|   Before using this medication, tell your doctor or pharmacist||
1650|106|P|your medical history, especially of: blood disorders (such as||
1650|107|P|anemia, low platelets, low white blood cells), bleeding problems,||
1650|108|P|heart disease (such as heart failure, angina, fast/irregular||
1650|109|P|heartbeat), liver disease, kidney disease, mental/mood disorders||
1650|110|P|(such as depression, psychosis, suicidal thoughts), seizures,||
1650|111|P|thyroid disease.||
1650|112|P|   Before having surgery, tell your doctor or dentist about all||
1650|113|P|the products you use (including prescription drugs,||
1650|114|P|nonprescription drugs, and herbal products).||
1650|115|P|   During pregnancy, this medication should be used only when||
1650|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
1650|117|P|   This medication passes into breast milk, but is unlikely to||
1650|118|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1650|119|B|||
1650|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1650|121|I|medications work or increase your risk for serious side effects.||
1650|122|I|This document does not contain all possible drug interactions.||
1650|123|I|Keep a list of all the products you use (including||
1650|124|I|prescription/nonprescription drugs and herbal products) and share||
1650|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1650|126|I|the dosage of any medicines without your doctor's approval.||
1650|127|B|||
1650|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1650|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1650|130|O|poison control center right away. US residents can call||
1650|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1650|132|B|||
1650|133|N|NOTES:  Do not share this medication with others.||
1650|134|N|   Lab and/or medical tests (such as liver function, complete||
1650|135|N|blood count) may be done while you are using this medication.||
1650|136|N|Keep all medical and lab appointments. Consult your doctor for||
1650|137|N|more details.||
1650|138|B|||
1650|139|D|MISSED DOSE:  It is important to use each dose of this medication||
1650|140|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1650|141|D|right away for a new dosing schedule. Do not double the dose to||
1650|142|D|catch up.||
1650|143|B|||
1650|144|R|STORAGE:  Store in the refrigerator. Do not freeze. Do not use||
1650|145|R|the medication if it has been frozen. Keep the medication in the||
1650|146|R|original carton to protect from light. This medication may be||
1650|147|R|taken out of the refrigerator and put back in the refrigerator if||
1650|148|R|needed. The total time out of the refrigerator should not be more||
1650|149|R|than 30 days. Keep all medications away from children and pets.||
1650|150|R|   Do not flush medications down the toilet or pour them into a||
1650|151|R|drain unless instructed to do so. Properly discard this product||
1650|152|R|when it is expired or no longer needed. Consult your pharmacist||
1650|153|R|or local waste disposal company.||
1650|154|B|||
1650|155|A|Information last revised April 2025.||
1650|156|A|Copyright(c) 2025 First Databank, Inc.||
1650|157|B|||
1651|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1651|002|Z|does NOT have all possible information about this product. This||
1651|003|Z|information does not assure that this product is safe, effective,||
1651|004|Z|or appropriate for you. This information is not individual||
1651|005|Z|medical advice and does not substitute for the advice of your||
1651|006|Z|health care professional. Always ask your health care||
1651|007|Z|professional for complete information about this product and your||
1651|008|Z|specific health needs.||
1651|009|B|||
1651|010|T|COBICISTAT - ORAL||
1651|011|F|(koe-BIK-i-stat)||
1651|012|B|||
1651|013|C|COMMON BRAND NAME(S): Tybost||
1651|014|B|||
1651|015|U|USES:  This drug is used to increase ("boost") the levels of||
1651|016|U|certain HIV protease inhibitors (atazanavir and darunavir). This||
1651|017|U|helps them work better to help control HIV infection.||
1651|018|U|   Cobicistat is not a cure for HIV infection. To decrease your||
1651|019|U|risk of spreading HIV disease to others, continue to take all HIV||
1651|020|U|medications exactly as prescribed by your doctor. Use an||
1651|021|U|effective barrier method (latex or polyurethane condoms/dental||
1651|022|U|dams) during sexual activity as directed by your doctor. Do not||
1651|023|U|share personal items (such as needles/syringes, toothbrushes, and||
1651|024|U|razors) that may have contacted blood or other body fluids.||
1651|025|U|Consult your doctor or pharmacist for more details.||
1651|026|B|||
1651|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1651|028|H|from your pharmacist before you start taking cobicistat and each||
1651|029|H|time you get a refill. If you have any questions, ask your doctor||
1651|030|H|or pharmacist.||
1651|031|H|   Take this medication by mouth with food as directed by your||
1651|032|H|doctor, usually once daily. Take cobicistat at the same time as||
1651|033|H|your HIV protease inhibitor.||
1651|034|H|   It is very important to keep taking this medication (and other||
1651|035|H|HIV medications) exactly as prescribed by your doctor. Do not||
1651|036|H|skip any doses.||
1651|037|H|   This medication works best when the amount of drug in your||
1651|038|H|body is kept at a constant level. Take this drug at evenly spaced||
1651|039|H|intervals. To help you remember, take it at the same time each||
1651|040|H|day.||
1651|041|H|   Do not take more or less of this drug than prescribed or stop||
1651|042|H|taking it (or other HIV medicines) even for a short time unless||
1651|043|H|directed to do so by your doctor. Doing so may cause the amount||
1651|044|H|of virus to increase, make the infection more difficult to treat||
1651|045|H|(resistant), or worsen side effects.||
1651|046|B|||
1651|047|S|SIDE EFFECTS:  Nausea may occur. If this lasts or gets worse,||
1651|048|S|tell your doctor or pharmacist promptly.||
1651|049|S|   Remember that this medication has been prescribed because your||
1651|050|S|doctor has judged that the benefit to you is greater than the||
1651|051|S|risk of side effects. Many people using this medication do not||
1651|052|S|have serious side effects.||
1651|053|S|   As your immune system gets stronger, it can begin to fight off||
1651|054|S|infections you already had, possibly causing disease symptoms to||
1651|055|S|come back. You could also have symptoms if your immune system||
1651|056|S|becomes overactive. This reaction may happen at any time (soon||
1651|057|S|after starting HIV treatment or many months later). Tell your||
1651|058|S|doctor right away if you have any serious symptoms, including:||
1651|059|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1651|060|S|that doesn't go away, headaches that are severe or don't go away,||
1651|061|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1651|062|S|changes, signs of infection (such as sore throat that doesn't go||
1651|063|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1651|064|S|sores), signs of an overactive thyroid (such as irritability,||
1651|065|S|nervousness, heat intolerance, fast/pounding/irregular heartbeat.||
1651|066|S|   Tell your doctor right away if you have any serious side||
1651|067|S|effects, including: nausea/vomiting that doesn't stop, loss of||
1651|068|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1651|069|S|urine.||
1651|070|S|   A very serious allergic reaction to this drug is rare.||
1651|071|S|However, get medical help right away if you notice any symptoms||
1651|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1651|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1651|074|S|breathing.||
1651|075|S|   This is not a complete list of possible side effects. If you||
1651|076|S|notice other effects not listed above, contact your doctor or||
1651|077|S|pharmacist.||
1651|078|S|   In the US -||
1651|079|S|   Call your doctor for medical advice about side effects. You||
1651|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1651|081|S|www.fda.gov/medwatch.||
1651|082|S|   In Canada - Call your doctor for medical advice about side||
1651|083|S|effects. You may report side effects to Health Canada at||
1651|084|S|1-866-234-2345.||
1651|085|B|||
1651|086|P|PRECAUTIONS:  Before taking cobicistat, tell your doctor or||
1651|087|P|pharmacist if you are allergic to it; or if you have any other||
1651|088|P|allergies. This product may contain inactive ingredients, which||
1651|089|P|can cause allergic reactions or other problems. Talk to your||
1651|090|P|pharmacist for more details.||
1651|091|P|   Before using this medication, tell your doctor or pharmacist||
1651|092|P|your medical history, especially of: kidney disease.||
1651|093|P|   Before having surgery, tell your doctor or dentist about all||
1651|094|P|the products you use (including prescription drugs,||
1651|095|P|nonprescription drugs, and herbal products).||
1651|096|P|   This medication is not recommended for use during pregnancy.||
1651|097|P|It may not work well in a pregnant woman. If you become pregnant||
1651|098|P|or think you may be pregnant, tell your doctor right away. Your||
1651|099|P|doctor may change your HIV medications.||
1651|100|P|   It is unknown if this medication passes into breast milk.||
1651|101|P|Because breast milk may transmit HIV, consult your doctor before||
1651|102|P|breastfeeding.||
1651|103|B|||
1651|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1651|105|I|medications work or increase your risk for serious side effects.||
1651|106|I|This document does not contain all possible drug interactions.||
1651|107|I|Keep a list of all the products you use (including||
1651|108|I|prescription/nonprescription drugs and herbal products) and share||
1651|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
1651|110|I|the dosage of any medicines without your doctor's approval.||
1651|111|I|   Some products that may interact with this drug include:||
1651|112|I|elvitegravir, orlistat, ritonavir.||
1651|113|I|   This medication can slow down the removal of other medications||
1651|114|I|from your body, which may affect how they work. Examples of||
1651|115|I|affected drugs include certain alpha blockers (such as alfuzosin,||
1651|116|I|tamsulosin), certain benzodiazepines (such as midazolam,||
1651|117|I|triazolam), dronedarone, ergot alkaloids (such as||
1651|118|I|dihydroergotamine, ergotamine), quinidine, pimozide, ranolazine,||
1651|119|I|rivaroxaban, salmeterol, certain drugs to treat erectile||
1651|120|I|dysfunction-ED or pulmonary hypertension (such as avanafil,||
1651|121|I|sildenafil), certain "statin" cholesterol drugs (lovastatin,||
1651|122|I|simvastatin), among others.||
1651|123|I|   Other medications can affect the removal of cobicistat from||
1651|124|I|your body, which may affect how cobicistat works. Examples||
1651|125|I|include certain drugs used to treat seizures (such as||
1651|126|I|carbamazepine, phenobarbital, phenytoin, primidone),||
1651|127|I|enzalutamide, certain HIV NNRTI drugs (such as efavirenz,||
1651|128|I|etravirine, nevirapine), mitotane, rifampin, St. John's wort,||
1651|129|I|among others.||
1651|130|I|   This medication may decrease the effectiveness of hormonal||
1651|131|I|birth control such as pills, patch, or ring. This could cause||
1651|132|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1651|133|I|use reliable backup birth control methods while using this||
1651|134|I|medication. Also tell your doctor if you have any new spotting or||
1651|135|I|breakthrough bleeding, because these may be signs that your birth||
1651|136|I|control is not working well.||
1651|137|I|   Do not take this medication with other products that contain||
1651|138|I|cobicistat.||
1651|139|B|||
1651|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1651|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1651|142|O|poison control center right away. US residents can call||
1651|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1651|144|B|||
1651|145|N|NOTES:  Do not share this medication with others.||
1651|146|N|   Lab and/or medical tests (such as kidney function) may be done||
1651|147|N|before you start taking this medication and while you are taking||
1651|148|N|it. Keep all medical and lab appointments. Consult your doctor||
1651|149|N|for more details.||
1651|150|B|||
1651|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1651|152|D|remember. If it is less than 12 hours before the next dose, skip||
1651|153|D|the missed dose. Take your next dose at the regular time. Do not||
1651|154|D|double the dose to catch up.||
1651|155|B|||
1651|156|R|STORAGE:  Store in the original container at room temperature||
1651|157|R|away from light and moisture. Do not store in the bathroom. Keep||
1651|158|R|all medications away from children and pets.||
1651|159|R|   Do not flush medications down the toilet or pour them into a||
1651|160|R|drain unless instructed to do so. Properly discard this product||
1651|161|R|when it is expired or no longer needed. Consult your pharmacist||
1651|162|R|or local waste disposal company.||
1651|163|B|||
1651|164|A|Information last revised April 2025.||
1651|165|A|Copyright(c) 2025 First Databank, Inc.||
1651|166|B|||
1652|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1652|002|Z|does NOT have all possible information about this product. This||
1652|003|Z|information does not assure that this product is safe, effective,||
1652|004|Z|or appropriate for you. This information is not individual||
1652|005|Z|medical advice and does not substitute for the advice of your||
1652|006|Z|health care professional. Always ask your health care||
1652|007|Z|professional for complete information about this product and your||
1652|008|Z|specific health needs.||
1652|009|B|||
1652|010|T|INFLUENZA VIRUS VACCINE PRESERVATIVE FREE - INTRAMUSCULAR||
1652|011|F|(IN-floo-EN-za)||
1652|012|B|||
1652|013|C|COMMON BRAND NAME(S): Afluria, Fluarix, Flublok, Flucelvax,||
1652|014|C|Flulaval, Fluvirin, Fluzone||
1652|015|B|||
1652|016|U|USES:  This vaccine is used to help prevent influenza ("flu") in||
1652|017|U|people 6 months and older. Influenza can cause serious (rarely||
1652|018|U|fatal) illness, especially in people at high risk from the||
1652|019|U|infection (such as young children, older adults, people with||
1652|020|U|chronic health problems). This vaccine is also called the||
1652|021|U|seasonal flu shot. It works by increasing the body's natural||
1652|022|U|defense (immunity) against the virus.||
1652|023|U|   Vaccination is the best way to protect against this infection.||
1652|024|U|It can help prevent the infection or decrease the seriousness of||
1652|025|U|the illness if you become infected. Since different types of flu||
1652|026|U|viruses cause infection every flu season, a new vaccine is made||
1652|027|U|and given every year.||
1652|028|U|   Vaccines may not fully protect everyone who receives them.||
1652|029|U|   The flu vaccine does not cause the flu.||
1652|030|B|||
1652|031|H|HOW TO USE:  Read all vaccine information available from your||
1652|032|H|health care professional before receiving the vaccine. If you||
1652|033|H|have any questions, ask your health care professional.||
1652|034|H|   This vaccine is given by injection into a muscle by a health||
1652|035|H|care professional. Some brands may also be given by deep||
1652|036|H|injection under the skin. This vaccine is given in the upper arm||
1652|037|H|for children and adults and in the thigh for infants.||
1652|038|H|   The vaccination is usually given once a year during September||
1652|039|H|to November, the time when the number of flu cases begin to||
1652|040|H|increase (the start of "flu season"). Children younger than 9||
1652|041|H|years may receive a second dose depending on when the first dose||
1652|042|H|was given. Discuss the dose schedule with your health care||
1652|043|H|professional.||
1652|044|B|||
1652|045|S|SIDE EFFECTS:  Soreness/redness/swelling/bruising at the||
1652|046|S|injection site, fever, muscle aches, headache, or weakness may||
1652|047|S|occur. If any of these effects last or get worse, tell your||
1652|048|S|health care professional promptly.||
1652|049|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1652|050|S|vision changes, or ringing in the ears just after getting a||
1652|051|S|vaccine injection. Tell your health care professional right away||
1652|052|S|if you have any of these symptoms. Sitting or lying down may||
1652|053|S|help, since these symptoms usually don't last long.||
1652|054|S|   Remember that this vaccine has been prescribed because your||
1652|055|S|health care professional has judged that the benefit to you is||
1652|056|S|greater than the risk of side effects. Many people using this||
1652|057|S|vaccine do not have serious side effects.||
1652|058|S|   Tell your health care professional right away if you have any||
1652|059|S|serious side effects, including: mental/mood changes,||
1652|060|S|numbness/tingling, muscle weakness, seizures.||
1652|061|S|   A very serious allergic reaction to this vaccine is rare.||
1652|062|S|However, get medical help right away if you notice any symptoms||
1652|063|S|of a serious allergic reaction, including: rash, severe||
1652|064|S|dizziness, itching/swelling (especially of the||
1652|065|S|face/tongue/throat), trouble breathing.||
1652|066|S|   This is not a complete list of possible side effects. If you||
1652|067|S|notice other effects not listed above, contact your health care||
1652|068|S|professional.||
1652|069|S|   Contact the health care professional for medical advice about||
1652|070|S|side effects. The following numbers do not provide medical||
1652|071|S|advice, but in the US you may report side effects to the Vaccine||
1652|072|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1652|073|S|Canada, you may call the Vaccine Safety Section at Public Health||
1652|074|S|Agency of Canada at 1-866-844-0018.||
1652|075|B|||
1652|076|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
1652|077|P|care professional if you are allergic to it; or if you have any||
1652|078|P|other allergies. This product may contain inactive ingredients||
1652|079|P|(such as latex found in some brands), which can cause allergic||
1652|080|P|reactions or other problems. Talk to your health care||
1652|081|P|professional for more details.||
1652|082|P|   Before receiving this vaccine, tell your health care||
1652|083|P|professional your medical history, especially of: current||
1652|084|P|fever/illness, nervous system disorders (such as seizures,||
1652|085|P|encephalopathy, Guillain-Barre syndrome), immune system disorders||
1652|086|P|(such as due to HIV infection, certain cancers such as||
1652|087|P|leukemia/lymphoma, cancer or radiation treatment), vaccination||
1652|088|P|history (including previous reactions to any vaccines).||
1652|089|P|   During pregnancy, flu vaccination is usually recommended.||
1652|090|P|Discuss the risks and benefits with your health care||
1652|091|P|professional.||
1652|092|P|   It is unknown if this vaccine passes into breast milk. Consult||
1652|093|P|your health care professional before breastfeeding.||
1652|094|B|||
1652|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1652|096|I|medications work or increase your risk for serious side effects.||
1652|097|I|This document does not contain all possible drug interactions.||
1652|098|I|Keep a list of all the products you use (including||
1652|099|I|prescription/nonprescription drugs and herbal products) and share||
1652|100|I|it with your health care professional. Do not start, stop, or||
1652|101|I|change the dosage of any medicines without your doctor's||
1652|102|I|approval.||
1652|103|B|||
1652|104|O|OVERDOSE:  Not applicable.||
1652|105|B|||
1652|106|N|NOTES:  Keep all medical and lab appointments.||
1652|107|N|   Keep vaccine records for yourself and your children and||
1652|108|N|provide them to the health care professionals to prevent||
1652|109|N|unnecessary re-vaccinations.||
1652|110|B|||
1652|111|D|MISSED DOSE:  This vaccine is usually given once every flu||
1652|112|D|season. If your child is prescribed a second dose, mark your||
1652|113|D|calendar with a reminder. If your child misses the dose, call the||
1652|114|D|health care professional to reschedule.||
1652|115|B|||
1652|116|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
1652|117|R|light. Keep all medications away from children and pets.||
1652|118|R|   Do not flush medications down the toilet or pour them into a||
1652|119|R|drain unless instructed to do so. Properly discard this product||
1652|120|R|when it is expired or no longer needed. Consult your pharmacist||
1652|121|R|or local waste disposal company.||
1652|122|B|||
1652|123|A|Information last revised February 2025.||
1652|124|A|Copyright(c) 2025 First Databank, Inc.||
1652|125|B|||
1653|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1653|002|Z|does NOT have all possible information about this product. This||
1653|003|Z|information does not assure that this product is safe, effective,||
1653|004|Z|or appropriate for you. This information is not individual||
1653|005|Z|medical advice and does not substitute for the advice of your||
1653|006|Z|health care professional. Always ask your health care||
1653|007|Z|professional for complete information about this product and your||
1653|008|Z|specific health needs.||
1653|009|B|||
1653|010|T|LEDIPASVIR/SOFOSBUVIR - ORAL||
1653|011|F|(le-DIP-as-vir/soe-FOS-buer-vir)||
1653|012|B|||
1653|013|C|COMMON BRAND NAME(S): Harvoni||
1653|014|B|||
1653|015|W|WARNING:  Although this medication is used to treat hepatitis C,||
1653|016|W|it may rarely make another liver problem called hepatitis B get||
1653|017|W|worse. Before starting this medication, tell your doctor if you||
1653|018|W|have ever had hepatitis B. Tell your doctor right away if you||
1653|019|W|have new or worsening symptoms of liver disease, such as||
1653|020|W|nausea/vomiting that doesn't stop, loss of appetite,||
1653|021|W|stomach/abdominal pain, dark urine or yellowing eyes/skin.||
1653|022|B|||
1653|023|U|USES:  This medication is a combination of ledipasvir and||
1653|024|U|sofosbuvir and is used to treat chronic (long-lasting) hepatitis||
1653|025|U|C, a viral infection of the liver. It may sometimes be used with||
1653|026|U|another antiviral medication (ribavirin). These drugs work by||
1653|027|U|reducing the amount of hepatitis C virus in your body, which||
1653|028|U|helps your immune system fight the infection and may help your||
1653|029|U|liver recover. Chronic hepatitis C infection can cause serious||
1653|030|U|liver problems such as scarring (cirrhosis), or liver cancer.||
1653|031|U|   It is not known if this treatment can prevent you from passing||
1653|032|U|the virus to others. Do not share needles, and practice "safer||
1653|033|U|sex" (including the use of latex condoms) to lower the risk of||
1653|034|U|passing the virus to others.||
1653|035|B|||
1653|036|H|HOW TO USE:  Read the Patient Information Leaflet and||
1653|037|H|Instructions for Use if available from your pharmacist before you||
1653|038|H|start taking ledipasvir/sofosbuvir and each time you get a||
1653|039|H|refill. If you have any questions, ask your doctor or pharmacist.||
1653|040|H|   Take this medication by mouth with or without food as directed||
1653|041|H|by your doctor, usually once daily. The dosage is based on your||
1653|042|H|medical condition and response to treatment. Children's dosage is||
1653|043|H|also based on weight.||
1653|044|H|   If you are using the pellet form of this medication, gently||
1653|045|H|shake the packet before use. To take this medication without||
1653|046|H|food, open the packet and pour the pellets directly into your||
1653|047|H|mouth. Swallow the pellets without chewing. You may drink water||
1653|048|H|after swallowing the pellets if needed. Repeat these steps if||
1653|049|H|your dose is for more than one packet. If you are taking this||
1653|050|H|medication with food, open the packet(s) and pour the pellets||
1653|051|H|into a small bowl with one or more spoonfuls of non-acidic soft||
1653|052|H|food (such as pudding, mashed potato, ice cream). The soft food||
1653|053|H|should be at or below room temperature. After gently mixing, take||
1653|054|H|all of the mixture without chewing within 30 minutes.||
1653|055|H|   This medication works best when the amount of drug in your||
1653|056|H|body is kept at a constant level. Take this drug at evenly spaced||
1653|057|H|intervals. To help you remember, take it at the same time each||
1653|058|H|day.||
1653|059|H|   Tell your doctor if you vomit within 5 hours after taking this||
1653|060|H|medication. You may need to take another dose.||
1653|061|H|   Continue to take ledipasvir/sofosbuvir for the full length of||
1653|062|H|time prescribed, even if symptoms disappear after a short time.||
1653|063|H|Stopping the medication too early may result in a return of the||
1653|064|H|infection.||
1653|065|H|   Antacids lower the absorption of ledipasvir. If you are taking||
1653|066|H|an antacid, take it at least 4 hours before or 4 hours after this||
1653|067|H|medication.||
1653|068|H|   Other acid-lowering medications for indigestion, heartburn, or||
1653|069|H|ulcers (such as prescription or over-the-counter medications||
1653|070|H|including famotidine, omeprazole) may prevent ledipasvir from||
1653|071|H|working. Ask your doctor or pharmacist how to use these||
1653|072|H|medications safely.||
1653|073|B|||
1653|074|S|SIDE EFFECTS:  See also Warning section.||
1653|075|S|   Tiredness, headache, nausea, diarrhea, or difficulty sleeping||
1653|076|S|may occur. If any of these effects last or get worse, tell your||
1653|077|S|doctor or pharmacist promptly.||
1653|078|S|   Remember that this medication has been prescribed because your||
1653|079|S|doctor has judged that the benefit to you is greater than the||
1653|080|S|risk of side effects. Many people using this medication do not||
1653|081|S|have serious side effects.||
1653|082|S|   A very serious allergic reaction to this drug is rare.||
1653|083|S|However, get medical help right away if you notice any symptoms||
1653|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1653|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1653|086|S|breathing.||
1653|087|S|   This is not a complete list of possible side effects. If you||
1653|088|S|notice other effects not listed above, contact your doctor or||
1653|089|S|pharmacist.||
1653|090|S|   In the US -||
1653|091|S|   Call your doctor for medical advice about side effects. You||
1653|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1653|093|S|www.fda.gov/medwatch.||
1653|094|S|   In Canada - Call your doctor for medical advice about side||
1653|095|S|effects. You may report side effects to Health Canada at||
1653|096|S|1-866-234-2345.||
1653|097|B|||
1653|098|P|PRECAUTIONS:  Before taking ledipasvir/sofosbuvir, tell your||
1653|099|P|doctor or pharmacist if you are allergic to either of the drugs;||
1653|100|P|or if you have any other allergies. This product may contain||
1653|101|P|inactive ingredients, which can cause allergic reactions or other||
1653|102|P|problems. Talk to your pharmacist for more details.||
1653|103|P|   Before using this medication, tell your doctor or pharmacist||
1653|104|P|your medical history, especially of: other liver problems (such||
1653|105|P|as hepatitis B), diabetes.||
1653|106|P|   If you have diabetes, your blood sugar may be lower with||
1653|107|P|hepatitis C treatment. This can increase your risk of low blood||
1653|108|P|sugar, so your doctor may adjust your diabetes treatment plan.||
1653|109|P|Tell your doctor right away if you have symptoms of low blood||
1653|110|P|sugar such as sudden sweating, shaking, fast heartbeat, hunger,||
1653|111|P|blurred vision, dizziness, or tingling hands/feet.||
1653|112|P|   Before having surgery, tell your doctor or dentist about all||
1653|113|P|the products you use (including prescription drugs,||
1653|114|P|nonprescription drugs, and herbal products).||
1653|115|P|   During pregnancy, this medication should be used only when||
1653|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
1653|117|P|Ledipasvir/sofosbuvir, in combination with ribavirin, must not be||
1653|118|P|used during pregnancy by either the pregnant woman or her male||
1653|119|P|partner. The combination may harm an unborn baby. Reliable forms||
1653|120|P|of birth control must be used whenever at least one sexual||
1653|121|P|partner is using these medicines together. Female patients should||
1653|122|P|keep using birth control for 9 months after stopping treatment.||
1653|123|P|Male patients should keep using birth control for 6 months after||
1653|124|P|stopping treatment. If you or your partner becomes pregnant, or||
1653|125|P|if you think you or your partner may be pregnant, tell your||
1653|126|P|doctor right away.||
1653|127|P|   It is unknown if this medication passes into breast milk.||
1653|128|P|Consult your doctor before breastfeeding.||
1653|129|B|||
1653|130|I|DRUG INTERACTIONS:  See also How to Use section.||
1653|131|I|   Drug interactions may change how your medications work or||
1653|132|I|increase your risk for serious side effects. This document does||
1653|133|I|not contain all possible drug interactions. Keep a list of all||
1653|134|I|the products you use (including prescription/nonprescription||
1653|135|I|drugs and herbal products) and share it with your doctor and||
1653|136|I|pharmacist. Do not start, stop, or change the dosage of any||
1653|137|I|medicines without your doctor's approval.||
1653|138|I|   A product that may interact with this drug is: amiodarone.||
1653|139|I|   This medication can slow down the removal of other medications||
1653|140|I|from your body, which may affect how they work. Examples include||
1653|141|I|flibanserin, rosuvastatin, among others.||
1653|142|I|   Other medications can affect the removal of||
1653|143|I|ledipasvir/sofosbuvir from your body, which may affect how this||
1653|144|I|medication works. Examples include apalutamide, rifamycins (such||
1653|145|I|as rifampin, rifabutin), St. John's wort, tipranavir/ritonavir,||
1653|146|I|drugs used to treat seizures (such as phenobarbital,||
1653|147|I|carbamazepine, phenytoin, primidone), among others.||
1653|148|I|   Do not take this medication with other products that contain||
1653|149|I|sofosbuvir.||
1653|150|B|||
1653|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1653|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1653|153|O|poison control center right away. US residents can call||
1653|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1653|155|B|||
1653|156|N|NOTES:  Do not share this medication with others.||
1653|157|N|   Lab tests (such as liver function, tests for hepatitis B and||
1653|158|N|C) should be done before you start using this medication, while||
1653|159|N|you are using it, and after completing treatment. Keep all||
1653|160|N|medical and lab appointments.||
1653|161|N|   If you are using this medication with ribavirin, it is||
1653|162|N|recommended that female patients or female partners of male||
1653|163|N|patients take a pregnancy test before starting this medication.||
1653|164|N|Pregnancy tests should continue to be done while using this||
1653|165|N|medication and for some time after this medication is stopped to||
1653|166|N|make sure no pregnancy occurs (for 9 months for female patients||
1653|167|N|and for 6 months for female partners of male patients).||
1653|168|B|||
1653|169|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1653|170|D|remember. If it is less than 6 hours before the next dose, skip||
1653|171|D|the missed dose. Take your next dose at the regular time. Do not||
1653|172|D|double the dose to catch up.||
1653|173|B|||
1653|174|R|STORAGE:  Store at room temperature away from light and moisture.||
1653|175|R|Store the tablets in the original container. For the pellets, do||
1653|176|R|not open the packets until you are ready to use the medication.||
1653|177|R|Do not store in the bathroom. Keep all medications away from||
1653|178|R|children and pets.||
1653|179|R|   Do not flush medications down the toilet or pour them into a||
1653|180|R|drain unless instructed to do so. Properly discard this product||
1653|181|R|when it is expired or no longer needed. Consult your pharmacist||
1653|182|R|or local waste disposal company.||
1653|183|B|||
1653|184|A|Information last revised August 2024.||
1653|185|A|Copyright(c) 2025 First Databank, Inc.||
1653|186|B|||
1654|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1654|002|Z|does NOT have all possible information about this product. This||
1654|003|Z|information does not assure that this product is safe, effective,||
1654|004|Z|or appropriate for you. This information is not individual||
1654|005|Z|medical advice and does not substitute for the advice of your||
1654|006|Z|health care professional. Always ask your health care||
1654|007|Z|professional for complete information about this product and your||
1654|008|Z|specific health needs.||
1654|009|B|||
1654|010|T|NINTEDANIB - ORAL||
1654|011|F|(nin-TED-a-nib)||
1654|012|B|||
1654|013|C|COMMON BRAND NAME(S): Ofev||
1654|014|B|||
1654|015|U|USES:  This medication is used to treat certain types of lung||
1654|016|U|disease (idiopathic pulmonary fibrosis- IPF, interstitial lung||
1654|017|U|disease). Both types of lung disease scar and stiffen your lungs,||
1654|018|U|making it hard to breathe. Nintedanib may help slow down the||
1654|019|U|worsening of your lung disease.||
1654|020|B|||
1654|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1654|022|H|from your pharmacist before you start taking nintedanib and each||
1654|023|H|time you get a refill. If you have any questions, ask your doctor||
1654|024|H|or pharmacist.||
1654|025|H|   Take this medication by mouth with food as directed by your||
1654|026|H|doctor, usually twice daily (about 12 hours apart). The dosage is||
1654|027|H|based on your medical condition and response to treatment. Follow||
1654|028|H|your doctor's instructions carefully.||
1654|029|H|   Swallow the capsule whole. Do not crush or chew because the||
1654|030|H|drug has a bitter taste. Do not open the capsules. Wash your||
1654|031|H|hands well right away if your skin comes in contact with the||
1654|032|H|content inside the capsules.||
1654|033|H|   Use this medication regularly to get the most benefit from it.||
1654|034|H|To help you remember, take it at the same times each day.||
1654|035|H|   Tell your doctor if your condition gets worse.||
1654|036|B|||
1654|037|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, abdominal pain,||
1654|038|S|decreased appetite, and weight loss may occur. If any of these||
1654|039|S|effects last or get worse, tell your doctor or pharmacist||
1654|040|S|promptly. Diarrhea, nausea, and vomiting can be severe. Your||
1654|041|S|doctor may have you drink more fluids if these symptoms occur and||
1654|042|S|prescribe medications to treat the diarrhea, nausea, and||
1654|043|S|vomiting.||
1654|044|S|   Remember that this medication has been prescribed because your||
1654|045|S|doctor has judged that the benefit to you is greater than the||
1654|046|S|risk of side effects. Many people using this medication do not||
1654|047|S|have serious side effects.||
1654|048|S|   This medication may raise your blood pressure. Check your||
1654|049|S|blood pressure regularly and tell your doctor if the results are||
1654|050|S|high. Your doctor may control your blood pressure with||
1654|051|S|medication.||
1654|052|S|   Tell your doctor right away if you have any serious side||
1654|053|S|effects, including: unusual bruising/bleeding, cough/stuffy||
1654|054|S|chest, foamy urine, swelling ankles/feet/hands, symptoms of liver||
1654|055|S|problems (such as dark urine, yellowing eyes/skin).||
1654|056|S|   Get medical help right away if you have any very serious side||
1654|057|S|effects, including: symptoms of a heart attack (such as||
1654|058|S|chest/jaw/left arm pain, unusual sweating), symptoms of a stroke||
1654|059|S|(such as weakness on one side of body, sudden vision problems,||
1654|060|S|trouble speaking), sudden/severe back pain or headache, severe||
1654|061|S|stomach/abdominal pain, abdominal swelling.||
1654|062|S|   A very serious allergic reaction to this drug is rare.||
1654|063|S|However, get medical help right away if you notice any symptoms||
1654|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1654|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1654|066|S|breathing.||
1654|067|S|   This is not a complete list of possible side effects. If you||
1654|068|S|notice other effects not listed above, contact your doctor or||
1654|069|S|pharmacist.||
1654|070|S|   In the US -||
1654|071|S|   Call your doctor for medical advice about side effects. You||
1654|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1654|073|S|www.fda.gov/medwatch.||
1654|074|S|   In Canada - Call your doctor for medical advice about side||
1654|075|S|effects. You may report side effects to Health Canada at||
1654|076|S|1-866-234-2345.||
1654|077|B|||
1654|078|P|PRECAUTIONS:  Before taking nintedanib, tell your doctor or||
1654|079|P|pharmacist if you are allergic to it; or if you have any other||
1654|080|P|allergies. This product may contain inactive ingredients which||
1654|081|P|can cause allergic reactions or other problems. Talk to your||
1654|082|P|pharmacist for more details.||
1654|083|P|   Before using this medication, tell your doctor or pharmacist||
1654|084|P|your medical history, especially of: liver disease, heart disease||
1654|085|P|(such as chest pain, heart attack), high blood pressure, blood||
1654|086|P|clots, bleeding problems, blood vessel problems (such as an||
1654|087|P|aneurysm or a tear/break in the aorta or other blood vessels),||
1654|088|P|recent abdominal surgery, stomach/intestinal problems (such as||
1654|089|P|ulcers, diverticular disease).||
1654|090|P|   Before having surgery, tell your doctor or dentist about all||
1654|091|P|the products you use (including prescription drugs,||
1654|092|P|nonprescription drugs, and herbal products).||
1654|093|P|   Tell your doctor if you are pregnant or plan to become||
1654|094|P|pregnant. You should not become pregnant while using nintedanib.||
1654|095|P|Nintedanib may harm an unborn baby. Your doctor should order a||
1654|096|P|pregnancy test before you start this medication. Ask about||
1654|097|P|reliable forms of birth control (such as condoms) while using||
1654|098|P|this medication and for at least 3 months after the last dose. If||
1654|099|P|you become pregnant, talk to your doctor right away about the||
1654|100|P|risks and benefits of this medication.||
1654|101|P|   It is unknown if nintedanib passes into breast milk. Consult||
1654|102|P|your doctor before breastfeeding.||
1654|103|B|||
1654|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1654|105|I|medications work or increase your risk for serious side effects.||
1654|106|I|This document does not contain all possible drug interactions.||
1654|107|I|Keep a list of all the products you use (including||
1654|108|I|prescription/nonprescription drugs and herbal products) and share||
1654|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
1654|110|I|the dosage of any medicines without your doctor's approval.||
1654|111|I|   Some products that may interact with this drug include: drugs||
1654|112|I|that can cause bleeding/bruising (including antiplatelet drugs||
1654|113|I|such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood||
1654|114|I|thinners" such as warfarin/dabigatran).||
1654|115|I|   Aspirin can increase the risk of bleeding when used with this||
1654|116|I|medication. However, if your doctor has told you to take low-dose||
1654|117|I|aspirin to prevent heart attack or stroke (usually 81-162||
1654|118|I|milligrams a day), you should keep taking the aspirin unless your||
1654|119|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1654|120|I|details.||
1654|121|I|   Other medications can affect the removal of nintedanib from||
1654|122|I|your body, which may affect how nintedanib works. Examples||
1654|123|I|include rifamycins (such as rifampicin), St. John's wort, drugs||
1654|124|I|used to treat seizures (such as carbamazepine, phenytoin), among||
1654|125|I|others.||
1654|126|I|   Cigarette smoking decreases blood levels of this medication.||
1654|127|I|Tell your doctor if you smoke or if you have recently stopped||
1654|128|I|smoking.||
1654|129|B|||
1654|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1654|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1654|132|O|poison control center right away. US residents can call||
1654|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1654|134|B|||
1654|135|N|NOTES:  Do not share this medication with others.||
1654|136|N|   Lab and/or medical tests (such as blood pressure, liver||
1654|137|N|function) should be done before you start taking this medication||
1654|138|N|and while you are taking it. Keep all medical and lab||
1654|139|N|appointments.||
1654|140|B|||
1654|141|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1654|142|D|next dose at the regular time. Do not double the dose to catch||
1654|143|D|up.||
1654|144|B|||
1654|145|R|STORAGE:  Store at room temperature away from light and moisture.||
1654|146|R|Do not store in the bathroom. Keep all medications away from||
1654|147|R|children and pets.||
1654|148|R|   Do not flush medications down the toilet or pour them into a||
1654|149|R|drain unless instructed to do so. Properly discard this product||
1654|150|R|when it is expired or no longer needed. Consult your pharmacist||
1654|151|R|or local waste disposal company.||
1654|152|B|||
1654|153|A|Information last revised January 2025.||
1654|154|A|Copyright(c) 2025 First Databank, Inc.||
1654|155|B|||
1655|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1655|002|Z|does NOT have all possible information about this product. This||
1655|003|Z|information does not assure that this product is safe, effective,||
1655|004|Z|or appropriate for you. This information is not individual||
1655|005|Z|medical advice and does not substitute for the advice of your||
1655|006|Z|health care professional. Always ask your health care||
1655|007|Z|professional for complete information about this product and your||
1655|008|Z|specific health needs.||
1655|009|B|||
1655|010|T|TIOTROPIUM - INHALATION||
1655|011|F|(TYE-oh-TROE-pee-um)||
1655|012|B|||
1655|013|C|COMMON BRAND NAME(S): Spiriva Respimat||
1655|014|B|||
1655|015|U|USES:  Tiotropium is used to treat lung diseases such as asthma||
1655|016|U|and COPD (bronchitis, emphysema). It must be used regularly to||
1655|017|U|prevent wheezing and shortness of breath. It works by relaxing||
1655|018|U|the muscles around the airways so that they open up and you can||
1655|019|U|breathe more easily. Tiotropium belongs to a class of drugs known||
1655|020|U|as anticholinergics. Controlling symptoms of breathing problems||
1655|021|U|can decrease time lost from work or school.||
1655|022|U|   This medication must be used regularly to be effective. It||
1655|023|U|does not work right away and should not be used to relieve sudden||
1655|024|U|breathing problems. If wheezing or sudden shortness of breath||
1655|025|U|occurs, use your quick-relief inhaler (such as albuterol, also||
1655|026|U|called salbutamol in some countries) as prescribed.||
1655|027|B|||
1655|028|H|HOW TO USE:  Read the Instructions for Use provided by your||
1655|029|H|pharmacist before you start using this medication and each time||
1655|030|H|you get a refill. Follow the illustrated directions for the||
1655|031|H|proper use of this medication. If you have any questions, ask||
1655|032|H|your doctor or pharmacist.||
1655|033|H|   Follow the instructions for test sprays in the air if you are||
1655|034|H|using the inhaler for the first time or if you have not used it||
1655|035|H|for more than 3 days or for more than 21 days. Make sure to spray||
1655|036|H|away from the face so that you do not get the medication into||
1655|037|H|your eyes. A slow-moving mist is a sign that the inhaler is||
1655|038|H|working properly.||
1655|039|H|   Inhale this medication by mouth as directed by your doctor,||
1655|040|H|usually 2 sprays once daily. Do not inhale more than 2 sprays in||
1655|041|H|24 hours.||
1655|042|H|   Avoid getting this medication into your eyes. It may cause eye||
1655|043|H|pain/irritation, temporary blurred vision, and other vision||
1655|044|H|changes. When using the inhaler, put your lips tightly around the||
1655|045|H|mouthpiece.||
1655|046|H|   Rinse your mouth after using the inhaler to prevent dry mouth||
1655|047|H|and throat irritation.||
1655|048|H|   If you are using other inhalers at the same time, wait at||
1655|049|H|least 1 minute between the use of each medication.||
1655|050|H|   Use this medication regularly to get the most benefit from it.||
1655|051|H|To help you remember, use it at the same time each day.||
1655|052|H|   Do not increase your dose or use this drug more often or for||
1655|053|H|longer than prescribed. Your condition will not improve any||
1655|054|H|faster, and your risk of side effects will increase.||
1655|055|H|   Clean the mouthpiece of the inhaler at least once a week as||
1655|056|H|directed.||
1655|057|H|   When this medication is used to treat asthma, it may take 4 to||
1655|058|H|8 weeks before you get the full benefit of this drug.||
1655|059|H|   Learn which of your inhalers you should use every day and||
1655|060|H|which you should use if your breathing suddenly worsens||
1655|061|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1655|062|H|should do if you have new or worsening cough or shortness of||
1655|063|H|breath, wheezing, increased sputum, waking up at night with||
1655|064|H|trouble breathing, if you use your quick-relief inhaler more||
1655|065|H|often, or if your quick-relief inhaler does not seem to be||
1655|066|H|working well. Learn when you can treat sudden breathing problems||
1655|067|H|by yourself and when you must get medical help right away.||
1655|068|H|   Tell your doctor if your symptoms do not get better or if they||
1655|069|H|get worse.||
1655|070|B|||
1655|071|S|SIDE EFFECTS:  Dry mouth and dizziness may occur. If either of||
1655|072|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1655|073|S|promptly.||
1655|074|S|   Remember that this medication has been prescribed because your||
1655|075|S|doctor has judged that the benefit to you is greater than the||
1655|076|S|risk of side effects. Many people using this medication do not||
1655|077|S|have serious side effects.||
1655|078|S|   Tell your doctor right away if you have any serious side||
1655|079|S|effects, including: difficulty urinating, painful urination.||
1655|080|S|   Rarely, this medication may cause severe sudden worsening of||
1655|081|S|breathing problems right after use. If you have sudden worsening||
1655|082|S|of breathing, use your quick-relief inhaler and get medical help||
1655|083|S|right away.||
1655|084|S|   Get medical help right away if you have any very serious side||
1655|085|S|effects, including: eye pain/swelling/redness, vision changes||
1655|086|S|(such as seeing rainbows around lights at night, blurred vision).||
1655|087|S|   A very serious allergic reaction to this drug is rare.||
1655|088|S|However, get medical help right away if you notice any symptoms||
1655|089|S|of a serious allergic reaction, including: rash, itching/swelling||
1655|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1655|091|S|breathing.||
1655|092|S|   This is not a complete list of possible side effects. If you||
1655|093|S|notice other effects not listed above, contact your doctor or||
1655|094|S|pharmacist.||
1655|095|S|   In the US -||
1655|096|S|   Call your doctor for medical advice about side effects. You||
1655|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1655|098|S|www.fda.gov/medwatch.||
1655|099|S|   In Canada - Call your doctor for medical advice about side||
1655|100|S|effects. You may report side effects to Health Canada at||
1655|101|S|1-866-234-2345.||
1655|102|B|||
1655|103|P|PRECAUTIONS:  Before using tiotropium, tell your doctor or||
1655|104|P|pharmacist if you are allergic to it; or to ipratropium; or to||
1655|105|P|atropine; or if you have any other allergies. This product may||
1655|106|P|contain inactive ingredients, which can cause allergic reactions||
1655|107|P|or other problems. Talk to your pharmacist for more details.||
1655|108|P|   Before using this medication, tell your doctor or pharmacist||
1655|109|P|your medical history, especially of: personal or family history||
1655|110|P|of glaucoma (angle-closure type), difficulty urinating, enlarged||
1655|111|P|prostate, kidney disease.||
1655|112|P|   This drug may make you dizzy or blur your vision. Alcohol or||
1655|113|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
1655|114|P|machinery, or do anything that needs alertness or clear vision||
1655|115|P|until you can do it safely. Limit alcoholic beverages. Talk to||
1655|116|P|your doctor if you are using marijuana (cannabis).||
1655|117|P|   Before having surgery, tell your doctor or dentist about all||
1655|118|P|the products you use (including prescription drugs,||
1655|119|P|nonprescription drugs, and herbal products).||
1655|120|P|   Older men may be at greater risk for difficulty urinating||
1655|121|P|while using this drug.||
1655|122|P|   During pregnancy, this medication should be used only when||
1655|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
1655|124|P|   It is unknown if this medication passes into breast milk.||
1655|125|P|Consult your doctor before breastfeeding.||
1655|126|B|||
1655|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1655|128|I|medications work or increase your risk for serious side effects.||
1655|129|I|This document does not contain all possible drug interactions.||
1655|130|I|Keep a list of all the products you use (including||
1655|131|I|prescription/nonprescription drugs and herbal products) and share||
1655|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
1655|133|I|the dosage of any medicines without your doctor's approval.||
1655|134|B|||
1655|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1655|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1655|137|O|poison control center right away. US residents can call||
1655|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1655|139|B|||
1655|140|N|NOTES:  Do not share this medication with others.||
1655|141|N|   Lab and/or medical tests (such as lung function) should be||
1655|142|N|done while you are using this medication. Keep all medical and||
1655|143|N|lab appointments.||
1655|144|N|   Avoid substances that can worsen breathing problems by causing||
1655|145|N|irritation or allergic reaction, such as smoke, pollen, pet||
1655|146|N|dander, dust, and mold.||
1655|147|N|   If you are using this medication to treat asthma, learn to use||
1655|148|N|a peak flow meter, use it daily, and promptly report worsening||
1655|149|N|breathing problems (such as readings in the yellow/red range,||
1655|150|N|increased use of quick-relief inhalers).||
1655|151|N|   Because the flu virus can worsen breathing problems, ask your||
1655|152|N|doctor or pharmacist if you should have a flu shot every year.||
1655|153|B|||
1655|154|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1655|155|D|If it is near the time of the next dose, skip the missed dose.||
1655|156|D|Use your next dose at the regular time. Do not double the dose to||
1655|157|D|catch up.||
1655|158|B|||
1655|159|R|STORAGE:  Store at room temperature. Do not freeze. Once the||
1655|160|R|cartridge is put into the inhaler, this medication expires after||
1655|161|R|3 months. Keep all medications away from children and pets.||
1655|162|R|   Do not flush medications down the toilet or pour them into a||
1655|163|R|drain unless instructed to do so. Properly discard this product||
1655|164|R|when it is expired or no longer needed. Consult your pharmacist||
1655|165|R|or local waste disposal company.||
1655|166|B|||
1655|167|M|MEDICAL ALERT:  Your condition can cause complications in a||
1655|168|M|medical emergency. For information about enrolling in MedicAlert,||
1655|169|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1655|170|B|||
1655|171|A|Information last revised July 2025.||
1655|172|A|Copyright(c) 2025 First Databank, Inc.||
1655|173|B|||
1656|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1656|002|Z|does NOT have all possible information about this product. This||
1656|003|Z|information does not assure that this product is safe, effective,||
1656|004|Z|or appropriate for you. This information is not individual||
1656|005|Z|medical advice and does not substitute for the advice of your||
1656|006|Z|health care professional. Always ask your health care||
1656|007|Z|professional for complete information about this product and your||
1656|008|Z|specific health needs.||
1656|009|B|||
1656|010|T|DARUNAVIR/COBICISTAT - ORAL||
1656|011|F|(dar-UE-na-vir/koe-BIK-i-stat)||
1656|012|B|||
1656|013|C|COMMON BRAND NAME(S): Prezcobix||
1656|014|B|||
1656|015|U|USES:  This product is used with other HIV medications to help||
1656|016|U|control HIV infection. It helps to decrease the amount of HIV in||
1656|017|U|your body so your immune system can work better. This lowers your||
1656|018|U|chance of getting HIV complications (such as new infections,||
1656|019|U|cancer) and improves your quality of life. This product is a||
1656|020|U|combination of two different drugs: darunavir and cobicistat.||
1656|021|U|Darunavir belongs to a class of drugs known as protease||
1656|022|U|inhibitors. Cobicistat is used to increase ("boost") the levels||
1656|023|U|of darunavir.||
1656|024|U|   Darunavir/cobicistat is not a cure for HIV infection. To||
1656|025|U|decrease your risk of spreading HIV disease to others, continue||
1656|026|U|to take all HIV medications exactly as prescribed by your doctor.||
1656|027|U|Use an effective barrier method (latex or polyurethane||
1656|028|U|condoms/dental dams) during sexual activity as directed by your||
1656|029|U|doctor. Do not share personal items (such as needles/syringes,||
1656|030|U|toothbrushes, and razors) that may have contacted blood or other||
1656|031|U|body fluids. Consult your doctor or pharmacist for more details.||
1656|032|B|||
1656|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1656|034|H|from your pharmacist before you start taking darunavir/cobicistat||
1656|035|H|and each time you get a refill. If you have any questions, ask||
1656|036|H|your doctor or pharmacist.||
1656|037|H|   Take this medication by mouth with food as directed by your||
1656|038|H|doctor, usually once daily. If you are unable to swallow the||
1656|039|H|tablet whole, some tablets may be split if they have a score line||
1656|040|H|and your doctor or pharmacist tells you to do so.||
1656|041|H|   It is very important to keep taking this medication (and other||
1656|042|H|HIV medications) exactly as prescribed by your doctor. Do not||
1656|043|H|skip any doses.||
1656|044|H|   For the best effect, take this medication at evenly spaced||
1656|045|H|times. To help you remember, take this medication at the same||
1656|046|H|time every day.||
1656|047|H|   Do not take more or less of this drug than prescribed or stop||
1656|048|H|taking it (or other HIV medicines) even for a short time unless||
1656|049|H|directed to do so by your doctor. Doing so may cause the amount||
1656|050|H|of virus to increase, make the infection more difficult to treat||
1656|051|H|(resistant), or worsen side effects.||
1656|052|B|||
1656|053|S|SIDE EFFECTS:  Diarrhea may occur. If this lasts or gets worse,||
1656|054|S|tell your doctor or pharmacist promptly.||
1656|055|S|   Remember that this medication has been prescribed because your||
1656|056|S|doctor has judged that the benefit to you is greater than the||
1656|057|S|risk of side effects. Many people using this medication do not||
1656|058|S|have serious side effects.||
1656|059|S|   As your immune system gets stronger, it can begin to fight off||
1656|060|S|infections you already had, possibly causing disease symptoms to||
1656|061|S|come back. You could also have symptoms if your immune system||
1656|062|S|becomes overactive. This reaction may happen at any time (soon||
1656|063|S|after starting HIV treatment or many months later). Tell your||
1656|064|S|doctor right away if you have any serious symptoms, including:||
1656|065|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1656|066|S|that doesn't go away, headaches that are severe or don't go away,||
1656|067|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1656|068|S|changes, signs of infection (such as sore throat that doesn't go||
1656|069|S|away, fever, chills, non-healing skin sores), signs of an||
1656|070|S|overactive thyroid (such as irritability, nervousness, heat||
1656|071|S|intolerance, fast/pounding/irregular heartbeat).||
1656|072|S|   This medication may rarely make your blood sugar rise, which||
1656|073|S|can cause or worsen diabetes. Tell your doctor right away if you||
1656|074|S|have symptoms of high blood sugar such as increased||
1656|075|S|thirst/urination. If you already have diabetes, check your blood||
1656|076|S|sugar regularly as directed and share the results with your||
1656|077|S|doctor. Your doctor may need to adjust your diabetes medication,||
1656|078|S|exercise program, or diet.||
1656|079|S|   Darunavir/cobicistat may rarely cause serious (possibly fatal)||
1656|080|S|liver disease. Get medical help right away if you have any||
1656|081|S|symptoms of liver damage, including: nausea/vomiting that doesn't||
1656|082|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
1656|083|S|eyes/skin, dark urine.||
1656|084|S|   Get medical help right away if you have any very serious side||
1656|085|S|effects, including: symptoms of a heart attack (such as||
1656|086|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
1656|087|S|easy bruising/bleeding.||
1656|088|S|   Changes in body fat may occur while you are taking this||
1656|089|S|medication (such as increased fat in the upper back and stomach||
1656|090|S|areas, decreased fat in the arms and legs). The cause and||
1656|091|S|long-term effects of these changes are unknown. Discuss the risks||
1656|092|S|and benefits of treatment with your doctor, as well as the||
1656|093|S|possible use of exercise to reduce this side effect.||
1656|094|S|   This medication can commonly cause a rash that is usually not||
1656|095|S|serious. However, you may not be able to tell it apart from a||
1656|096|S|rare rash that could be a sign of a severe reaction. Get medical||
1656|097|S|help right away if you develop any rash, especially with symptoms||
1656|098|S|such as fever, tiredness, muscle/joint pain, blisters, mouth||
1656|099|S|sores, or red/swollen eyes.||
1656|100|S|   A very serious allergic reaction to this drug is rare.||
1656|101|S|However, get medical help right away if you notice any symptoms||
1656|102|S|of a serious allergic reaction, including: swollen lymph nodes,||
1656|103|S|rash, itching/swelling (especially of the face/tongue/throat),||
1656|104|S|severe dizziness, trouble breathing.||
1656|105|S|   This is not a complete list of possible side effects. If you||
1656|106|S|notice other effects not listed above, contact your doctor or||
1656|107|S|pharmacist.||
1656|108|S|   In the US -||
1656|109|S|   Call your doctor for medical advice about side effects. You||
1656|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1656|111|S|www.fda.gov/medwatch.||
1656|112|S|   In Canada - Call your doctor for medical advice about side||
1656|113|S|effects. You may report side effects to Health Canada at||
1656|114|S|1-866-234-2345.||
1656|115|B|||
1656|116|P|PRECAUTIONS:  Before taking darunavir/cobicistat, tell your||
1656|117|P|doctor or pharmacist if you are allergic to either of the||
1656|118|P|medications; or if you have any other allergies. This product may||
1656|119|P|contain inactive ingredients, which can cause allergic reactions||
1656|120|P|or other problems. Talk to your pharmacist for more details.||
1656|121|P|   Before using this medication, tell your doctor or pharmacist||
1656|122|P|your medical history, especially of: liver disease (including||
1656|123|P|hepatitis B, C), kidney disease, a certain bleeding problem||
1656|124|P|(hemophilia), diabetes, heart problems (coronary artery disease,||
1656|125|P|heart attack), lipid problems (high cholesterol or||
1656|126|P|triglycerides/fats).||
1656|127|P|   Before having surgery, tell your doctor or dentist about all||
1656|128|P|the products you use (including prescription drugs,||
1656|129|P|nonprescription drugs, and herbal products).||
1656|130|P|   This medication is not recommended for use during pregnancy.||
1656|131|P|It may not work well in a pregnant woman. If you become pregnant||
1656|132|P|or think you may be pregnant, tell your doctor right away. Your||
1656|133|P|doctor may change your HIV medications.||
1656|134|P|   Darunavir passes into breast milk. It is unknown if cobicistat||
1656|135|P|passes into breast milk. Because breast milk may transmit HIV,||
1656|136|P|consult your doctor before breastfeeding.||
1656|137|B|||
1656|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1656|139|I|medications work or increase your risk for serious side effects.||
1656|140|I|This document does not contain all possible drug interactions.||
1656|141|I|Keep a list of all the products you use (including||
1656|142|I|prescription/nonprescription drugs and herbal products) and share||
1656|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
1656|144|I|the dosage of any medicines without your doctor's approval.||
1656|145|I|   Some products that may interact with this drug include:||
1656|146|I|elvitegravir, orlistat, ritonavir.||
1656|147|I|   This medication can slow down the removal of other medications||
1656|148|I|from your body, which may affect how they work. Examples of||
1656|149|I|affected drugs include certain alpha blockers (such as alfuzosin,||
1656|150|I|tamsulosin), certain benzodiazepines (such as midazolam,||
1656|151|I|triazolam), dronedarone, ergot alkaloids (such as||
1656|152|I|dihydroergotamine, ergotamine), lomitapide, quinidine, pimozide,||
1656|153|I|ranolazine, rivaroxaban, salmeterol, certain drugs to treat||
1656|154|I|erectile dysfunction-ED or pulmonary hypertension (such as||
1656|155|I|avanafil, sildenafil), certain "statin" cholesterol drugs||
1656|156|I|(lovastatin, simvastatin), among others.||
1656|157|I|   Other medications can affect the removal of this medication||
1656|158|I|from your body, which may affect how this medication works.||
1656|159|I|Examples include apalutamide, certain drugs used to treat||
1656|160|I|seizures (such as carbamazepine, phenobarbital, phenytoin,||
1656|161|I|primidone), garlic supplements, certain HIV NNRTI drugs (such as||
1656|162|I|efavirenz, etravirine, nevirapine), certain rifamycins (such as||
1656|163|I|rifampin, rifapentine), mitotane, St. John's wort, among others.||
1656|164|I|   This medication may decrease the effectiveness of hormonal||
1656|165|I|birth control such as pills, patch, or ring. This could cause||
1656|166|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1656|167|I|use reliable backup birth control methods while using this||
1656|168|I|medication. Also tell your doctor if you have any new spotting or||
1656|169|I|breakthrough bleeding, because these may be signs that your birth||
1656|170|I|control is not working well.||
1656|171|I|   Do not take this medication with other products that contain||
1656|172|I|darunavir or cobicistat.||
1656|173|B|||
1656|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1656|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1656|176|O|poison control center right away. US residents can call||
1656|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1656|178|B|||
1656|179|N|NOTES:  Do not share this medication with others.||
1656|180|N|   Lab and/or medical tests (such as liver/kidney function, viral||
1656|181|N|load, T-cell counts, triglycerides/cholesterol, blood sugar)||
1656|182|N|should be done before you start taking this medication and while||
1656|183|N|you are taking it. Keep all medical and lab appointments. Consult||
1656|184|N|your doctor for more details.||
1656|185|B|||
1656|186|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1656|187|D|remember. If it is less than 12 hours before the next dose, skip||
1656|188|D|the missed dose. Take your next dose at the regular time. Do not||
1656|189|D|double the dose to catch up.||
1656|190|B|||
1656|191|R|STORAGE:  Store at room temperature away from light and moisture.||
1656|192|R|Do not store in the bathroom. Keep all medications away from||
1656|193|R|children and pets.||
1656|194|R|   Do not flush medications down the toilet or pour them into a||
1656|195|R|drain unless instructed to do so. Properly discard this product||
1656|196|R|when it is expired or no longer needed. Consult your pharmacist||
1656|197|R|or local waste disposal company.||
1656|198|B|||
1656|199|A|Information last revised August 2025.||
1656|200|A|Copyright(c) 2025 First Databank, Inc.||
1656|201|B|||
1659|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1659|002|Z|does NOT have all possible information about this product. This||
1659|003|Z|information does not assure that this product is safe, effective,||
1659|004|Z|or appropriate for you. This information is not individual||
1659|005|Z|medical advice and does not substitute for the advice of your||
1659|006|Z|health care professional. Always ask your health care||
1659|007|Z|professional for complete information about this product and your||
1659|008|Z|specific health needs.||
1659|009|B|||
1659|010|T|DIPHTHERIA/TETANUS VACCINE (ADULT) PF - INJECTION||
1659|011|F|(dip-THEER-ee-uh AND TET-un-us)||
1659|012|B|||
1659|013|C|COMMON BRAND NAME(S): Tenivac||
1659|014|B|||
1659|015|U|USES:  This vaccine is used to help prevent diphtheria and||
1659|016|U|tetanus (lockjaw) in people 7 years and older. Vaccination is the||
1659|017|U|best way to protect against these life-threatening diseases. This||
1659|018|U|vaccine works by increasing the body's natural defense (immunity)||
1659|019|U|against the bacteria.||
1659|020|U|   Vaccines may not fully protect everyone who receives them.||
1659|021|B|||
1659|022|H|HOW TO USE:  Read all vaccine information available from your||
1659|023|H|health care professional before receiving the vaccine. If you||
1659|024|H|have any questions, ask your health care professional.||
1659|025|H|   This vaccine is given by injection into the muscle of the||
1659|026|H|upper arm by a health care professional.||
1659|027|H|   Vaccines are usually given in a series of doses to provide the||
1659|028|H|best protection. Closely follow the vaccination schedule provided||
1659|029|H|by your health care professional. To help you remember, mark your||
1659|030|H|calendar with a reminder.||
1659|031|H|   This vaccine may be given at the same time as other vaccines.||
1659|032|B|||
1659|033|S|SIDE EFFECTS:  Pain/redness/warmth/bruising/swelling at the||
1659|034|S|injection site, tiredness, fever, or headache may occur. If any||
1659|035|S|of these effects last or get worse, tell the health care||
1659|036|S|professional promptly.||
1659|037|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1659|038|S|vision changes, or ringing in the ears just after getting a||
1659|039|S|vaccine injection. Tell your health care professional right away||
1659|040|S|if you have any of these symptoms. Sitting or lying down may||
1659|041|S|help, since these symptoms usually don't last long.||
1659|042|S|   Remember that this vaccine has been prescribed because the||
1659|043|S|health care professional has judged that the benefit to you or||
1659|044|S|your child is greater than the risk of side effects. Many people||
1659|045|S|using this vaccine do not have serious side effects.||
1659|046|S|   Tell your health care professional right away if you or your||
1659|047|S|child have any serious side effects, including: muscle weakness,||
1659|048|S|numbness/tingling, severe pain/swelling at the injection site.||
1659|049|S|   A very serious allergic reaction to this vaccine is rare.||
1659|050|S|However, get medical help right away if you notice any symptoms||
1659|051|S|of a serious allergic reaction, including: rash, itching/swelling||
1659|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1659|053|S|breathing.||
1659|054|S|   This is not a complete list of possible side effects. If you||
1659|055|S|notice other effects not listed above, contact the health care||
1659|056|S|professional.||
1659|057|S|   Contact the health care professional for medical advice about||
1659|058|S|side effects. The following numbers do not provide medical||
1659|059|S|advice, but in the US you may report side effects to the Vaccine||
1659|060|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1659|061|S|Canada, you may call the Vaccine Safety Section at Public Health||
1659|062|S|Agency of Canada at 1-866-844-0018.||
1659|063|B|||
1659|064|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
1659|065|P|care professional if you are allergic to it; or if you have any||
1659|066|P|other allergies. This product may contain inactive ingredients,||
1659|067|P|which can cause allergic reactions or other problems. Talk to||
1659|068|P|your health care professional for more details.||
1659|069|P|   Before receiving this vaccine, tell your health care||
1659|070|P|professional your medical history, especially of: current||
1659|071|P|fever/illness, vaccination history (including previous reactions||
1659|072|P|to any vaccines), a certain nerve disorder (Guillain-Barre||
1659|073|P|syndrome), immune system disorders (such as due to HIV infection,||
1659|074|P|certain cancers such as leukemia/lymphoma, cancer or radiation||
1659|075|P|treatment).||
1659|076|P|   During pregnancy, this vaccine should be used only when||
1659|077|P|clearly needed. Discuss the risks and benefits with your health||
1659|078|P|care professional.||
1659|079|P|   It is unknown if this vaccine passes into breast milk. Consult||
1659|080|P|your health care professional before breastfeeding.||
1659|081|B|||
1659|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1659|083|I|medications work or increase your risk for serious side effects.||
1659|084|I|This document does not contain all possible drug interactions.||
1659|085|I|Keep a list of all the products you use (including||
1659|086|I|prescription/nonprescription drugs and herbal products) and share||
1659|087|I|it with your health care professional. Do not start, stop, or||
1659|088|I|change the dosage of any medicines without your doctor's||
1659|089|I|approval.||
1659|090|I|   Some products that may interact with this vaccine are: drugs||
1659|091|I|that weaken the immune system (such as cyclosporine, tacrolimus,||
1659|092|I|cancer chemotherapy, corticosteroids such as prednisone).||
1659|093|B|||
1659|094|O|OVERDOSE:  Not applicable.||
1659|095|B|||
1659|096|N|NOTES:  Keep all medical and lab appointments.||
1659|097|N|   Keep vaccine records for yourself and your children and||
1659|098|N|provide them to the health care professionals to prevent||
1659|099|N|unnecessary re-vaccinations.||
1659|100|B|||
1659|101|D|MISSED DOSE:  It is important that you or your child get each||
1659|102|D|vaccination as scheduled. Ask when you or your child should get||
1659|103|D|each dose and mark your calendar with a reminder. If you or your||
1659|104|D|child miss a dose, call the health care professional to||
1659|105|D|reschedule.||
1659|106|B|||
1659|107|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
1659|108|R|medications away from children and pets.||
1659|109|R|   Do not flush medications down the toilet or pour them into a||
1659|110|R|drain unless instructed to do so. Properly discard this product||
1659|111|R|when it is expired or no longer needed. Consult your pharmacist||
1659|112|R|or local waste disposal company.||
1659|113|B|||
1659|114|A|Information last revised February 2025.||
1659|115|A|Copyright(c) 2025 First Databank, Inc.||
1659|116|B|||
1661|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1661|002|Z|does NOT have all possible information about this product. This||
1661|003|Z|information does not assure that this product is safe, effective,||
1661|004|Z|or appropriate for you. This information is not individual||
1661|005|Z|medical advice and does not substitute for the advice of your||
1661|006|Z|health care professional. Always ask your health care||
1661|007|Z|professional for complete information about this product and your||
1661|008|Z|specific health needs.||
1661|009|B|||
1661|010|T|BUDESONIDE FOAM - RECTAL||
1661|011|F|(bue-DES-oh-nide)||
1661|012|B|||
1661|013|C|COMMON BRAND NAME(S): Uceris||
1661|014|B|||
1661|015|U|USES:  This medication is used to treat symptoms of a certain||
1661|016|U|bowel disease (ulcerative colitis). It works by reducing swelling||
1661|017|U|(inflammation). Budesonide belongs to a class of drugs known as||
1661|018|U|corticosteroids. Budesonide does not cure ulcerative colitis, but||
1661|019|U|it may help relieve symptoms such as abdominal pain, diarrhea,||
1661|020|U|and bloody stools. Using this medication as a foam allows it to||
1661|021|U|work directly on the bowel and rectum.||
1661|022|B|||
1661|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1661|024|H|from your pharmacist before you start using budesonide and each||
1661|025|H|time you get a refill. Follow the illustrated directions for the||
1661|026|H|proper use of this medication. If you have any questions, ask||
1661|027|H|your doctor or pharmacist.||
1661|028|H|   Use this medication as a foam in the rectum as directed by||
1661|029|H|your doctor, usually in the morning and evening for the first 2||
1661|030|H|weeks, then once a day in the evening for the next 4 weeks. It is||
1661|031|H|best to use this medication just before bedtime in the evening.||
1661|032|H|   This medication is flammable until dry. Avoid smoking or being||
1661|033|H|near open flames while using the medication and until the||
1661|034|H|medication has dried.||
1661|035|H|   It is best to use this medication after a bowel movement. You||
1661|036|H|may apply this medication while standing, lying down, or sitting.||
1661|037|H|Do not insert any part of the canister into the anus. Use the||
1661|038|H|enclosed applicator to apply this drug. Follow the instructions||
1661|039|H|for attaching the applicator to the canister. Warm the canister||
1661|040|H|in your hands and shake the canister well for 10 to 15 seconds||
1661|041|H|before use. Hold the canister upside down and gently insert the||
1661|042|H|applicator tip into the anus. Push down on the pump and hold it||
1661|043|H|in that position for 2 seconds to apply the foam. Afterward,||
1661|044|H|release your finger from the pump and continue to hold the||
1661|045|H|applicator in place for 10 to 15 seconds. Then, remove the||
1661|046|H|applicator and throw it away. Wash your hands after use. Keep the||
1661|047|H|medication in your rectum for as long as possible, for example||
1661|048|H|overnight.||
1661|049|H|   If you are regularly taking a different corticosteroid by||
1661|050|H|mouth (such as prednisone), you should not stop taking it unless||
1661|051|H|directed by your doctor. Some conditions (such as asthma,||
1661|052|H|allergies) may become worse when the drug is suddenly stopped. If||
1661|053|H|you suddenly stop taking the drug, you may also have withdrawal||
1661|054|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
1661|055|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
1661|056|H|doctor may slowly lower the dose of your old medication after you||
1661|057|H|begin using budesonide. Tell your doctor or pharmacist right away||
1661|058|H|if you have withdrawal. See also Precautions section.||
1661|059|H|   Use this medication regularly to get the most benefit from it.||
1661|060|H|To help you remember, use it at the same time(s) each day. Do not||
1661|061|H|increase your dose or use this drug more often or for longer than||
1661|062|H|prescribed. Your condition will not improve any faster, and your||
1661|063|H|risk of side effects will increase.||
1661|064|H|   Do not stop using this medication without consulting your||
1661|065|H|doctor. Some conditions may become worse when this drug is||
1661|066|H|suddenly stopped. Your dose may need to be gradually decreased.||
1661|067|H|   Tell your doctor if your condition lasts or gets worse.||
1661|068|B|||
1661|069|S|SIDE EFFECTS:  Nausea may occur. If this effect lasts or gets||
1661|070|S|worse, tell your doctor or pharmacist promptly.||
1661|071|S|   Remember that this medication has been prescribed because your||
1661|072|S|doctor has judged that the benefit to you is greater than the||
1661|073|S|risk of side effects. Many people using this medication do not||
1661|074|S|have serious side effects.||
1661|075|S|   Rarely, it is possible this medication will be absorbed into||
1661|076|S|the bloodstream. This can lead to side effects of too much||
1661|077|S|corticosteroid. These side effects are more likely in children||
1661|078|S|and people who use this medication for a long time. Tell your||
1661|079|S|doctor right away if any of the following side effects occur:||
1661|080|S|unusual/extreme tiredness, weight loss, headache, swelling||
1661|081|S|ankles/feet, increased thirst/urination, vision problems, bone||
1661|082|S|pain, mental/mood changes (such as psychosis, anxiety,||
1661|083|S|depression), symptoms of stomach/intestinal bleeding (such as||
1661|084|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
1661|085|S|coffee grounds).||
1661|086|S|   This medication may lower your ability to fight infections.||
1661|087|S|This may make you more likely to get a serious (rarely fatal)||
1661|088|S|infection or make any infection you have worse. Tell your doctor||
1661|089|S|right away if you have any signs of infection (such as sore||
1661|090|S|throat that doesn't go away, fever, chills).||
1661|091|S|   A very serious allergic reaction to this drug is rare.||
1661|092|S|However, get medical help right away if you notice any symptoms||
1661|093|S|of a serious allergic reaction, including: rash, itching/swelling||
1661|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1661|095|S|breathing.||
1661|096|S|   This is not a complete list of possible side effects. If you||
1661|097|S|notice other effects not listed above, contact your doctor or||
1661|098|S|pharmacist.||
1661|099|S|   In the US -||
1661|100|S|   Call your doctor for medical advice about side effects. You||
1661|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1661|102|S|www.fda.gov/medwatch.||
1661|103|S|   In Canada - Call your doctor for medical advice about side||
1661|104|S|effects. You may report side effects to Health Canada at||
1661|105|S|1-866-234-2345.||
1661|106|B|||
1661|107|P|PRECAUTIONS:  Before using budesonide, tell your doctor or||
1661|108|P|pharmacist if you are allergic to it; or if you have any other||
1661|109|P|allergies. This product may contain inactive ingredients, which||
1661|110|P|can cause allergic reactions or other problems. Talk to your||
1661|111|P|pharmacist for more details.||
1661|112|P|   Before using this medication, tell your doctor or pharmacist||
1661|113|P|your medical history, especially of: liver disease, high blood||
1661|114|P|pressure, personal or family history of diabetes, bone loss||
1661|115|P|(osteoporosis), stomach/intestinal ulcer, a certain bowel disease||
1661|116|P|(diverticulitis), mental/mood disorders (such as depression,||
1661|117|P|psychosis), personal or family history of high pressure in the||
1661|118|P|eye (glaucoma), cataracts, current/past infections (such as||
1661|119|P|tuberculosis, ocular herpes simplex, fungal), thyroid problems.||
1661|120|P|   Rarely, using corticosteroid medications for a long time can||
1661|121|P|make it more difficult for your body to respond to physical||
1661|122|P|stress. Before having surgery or emergency treatment, or if you||
1661|123|P|get a serious illness/injury, tell your doctor or dentist that||
1661|124|P|you are using this medication or have used this medication within||
1661|125|P|the past few months.||
1661|126|P|   Before having surgery, tell your doctor or dentist about all||
1661|127|P|the products you use (including prescription drugs,||
1661|128|P|nonprescription drugs, and herbal products).||
1661|129|P|   Budesonide may mask signs of infection. It can make you more||
1661|130|P|likely to get infections or may make current infections worse.||
1661|131|P|Stay away from anyone who has an infection that may easily spread||
1661|132|P|(such as chickenpox, COVID-19, measles, flu). Talk to your doctor||
1661|133|P|if you have been exposed to an infection or for more details.||
1661|134|P|   Tell your health care professional that you are using||
1661|135|P|budesonide before having any immunizations/vaccinations. Avoid||
1661|136|P|contact with people who have recently received live vaccines||
1661|137|P|(such as flu vaccine inhaled through the nose).||
1661|138|P|   Older adults may be more sensitive to the side effects of this||
1661|139|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
1661|140|P|mental/mood changes (such as confusion).||
1661|141|P|   Though it is unlikely, this medication may temporarily slow||
1661|142|P|down a child's growth if used for a long time. See the doctor||
1661|143|P|regularly so your child's height can be checked.||
1661|144|P|   During pregnancy, this medication should be used only when||
1661|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
1661|146|P|Babies born to mothers who have used corticosteroids for a long||
1661|147|P|time may develop hormone problems. Tell your doctor right away if||
1661|148|P|you notice symptoms such as nausea/vomiting that doesn't stop,||
1661|149|P|severe diarrhea, or weakness in your newborn.||
1661|150|P|   This medication passes into breast milk. Consult your doctor||
1661|151|P|before breastfeeding.||
1661|152|B|||
1661|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1661|154|I|medications work or increase your risk for serious side effects.||
1661|155|I|This document does not contain all possible drug interactions.||
1661|156|I|Keep a list of all the products you use (including||
1661|157|I|prescription/nonprescription drugs and herbal products) and share||
1661|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
1661|159|I|the dosage of any medicines without your doctor's approval.||
1661|160|I|   Some products that may interact with this drug include:||
1661|161|I|aldesleukin, desmopressin, mifepristone, drugs that can cause||
1661|162|I|bleeding/bruising (including antiplatelet drugs such as||
1661|163|I|clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs||
1661|164|I|such as aspirin/celecoxib/ibuprofen).||
1661|165|I|   If your doctor has told you to take low-dose aspirin to||
1661|166|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
1661|167|I|you should keep taking the aspirin unless your doctor tells you||
1661|168|I|not to. Ask your doctor or pharmacist for more details.||
1661|169|B|||
1661|170|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1661|171|O|has overdosed and has serious symptoms such as passing out or||
1661|172|O|trouble breathing, call 911. Otherwise, call a poison control||
1661|173|O|center right away. US residents can call 1-800-222-1222. Canada||
1661|174|O|residents can call 1-844-764-7669.||
1661|175|B|||
1661|176|N|NOTES:  Do not share this medication with others.||
1661|177|N|   This medication may cause bone loss (osteoporosis) when used||
1661|178|N|for a long time. Lifestyle changes that may help reduce the risk||
1661|179|N|of bone problems include doing weight-bearing exercise, stopping||
1661|180|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
1661|181|N|D. Talk to your doctor for more details.||
1661|182|B|||
1661|183|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1661|184|D|If it is near the time of the next dose, skip the missed dose.||
1661|185|D|Use your next dose at the regular time. Do not double the dose to||
1661|186|D|catch up.||
1661|187|B|||
1661|188|R|STORAGE:  Store at room temperature. This medication is||
1661|189|R|flammable. Keep it away from heat and open flame. Keep all||
1661|190|R|medications away from children and pets.||
1661|191|R|   Do not flush medications down the toilet or pour them into a||
1661|192|R|drain unless instructed to do so. Properly discard this product||
1661|193|R|when it is expired or no longer needed. Consult your pharmacist||
1661|194|R|or local waste disposal company.||
1661|195|B|||
1661|196|A|Information last revised September 2025.||
1661|197|A|Copyright(c) 2025 First Databank, Inc.||
1661|198|B|||
1662|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1662|002|Z|does NOT have all possible information about this product. This||
1662|003|Z|information does not assure that this product is safe, effective,||
1662|004|Z|or appropriate for you. This information is not individual||
1662|005|Z|medical advice and does not substitute for the advice of your||
1662|006|Z|health care professional. Always ask your health care||
1662|007|Z|professional for complete information about this product and your||
1662|008|Z|specific health needs.||
1662|009|B|||
1662|010|T|BLINATUMOMAB - INJECTION||
1662|011|F|(BLIN-a-TOOM-oh-mab)||
1662|012|B|||
1662|013|C|COMMON BRAND NAME(S): Blincyto||
1662|014|B|||
1662|015|W|WARNING:  Blinatumomab may cause certain serious (sometimes||
1662|016|W|fatal) side effects, including cytokine release syndrome-CRS and||
1662|017|W|infusion reactions. Symptoms may include fever, chills, headache,||
1662|018|W|nausea, vomiting, stomach/abdominal pain, trouble breathing, skin||
1662|019|W|rash, weakness, or low blood pressure. Blinatumomab can also||
1662|020|W|cause serious brain, spinal cord, and nerve disorders with||
1662|021|W|symptoms such as headache, trouble sleeping, seizures, confusion,||
1662|022|W|loss of consciousness, difficulty with swallowing/facial||
1662|023|W|movements, or speech and balance problems. Tell your doctor right||
1662|024|W|away if you develop any of these symptoms.||
1662|025|W|   You may be given this medication in a hospital or clinic so||
1662|026|W|your doctor can watch for these serious side effects and provide||
1662|027|W|treatment if needed. If you have side effects, your doctor may||
1662|028|W|temporarily stop or slow down your treatment with this||
1662|029|W|medication. Also, your doctor may prescribe other medications||
1662|030|W|before you receive blinatumomab to decrease the risk of side||
1662|031|W|effects.||
1662|032|B|||
1662|033|U|USES:  This medication is used to treat a certain type of cancer||
1662|034|U|(acute lymphoblastic leukemia-ALL). Blinatumomab belongs to a||
1662|035|U|class of drugs known as monoclonal antibodies. It works by||
1662|036|U|slowing or stopping the growth of cancer cells.||
1662|037|B|||
1662|038|H|HOW TO USE:  See also Warning section.||
1662|039|H|   Read the Medication Guide provided by your pharmacist before||
1662|040|H|you start using blinatumomab and each time you get a refill. If||
1662|041|H|you have any questions, ask your doctor or pharmacist.||
1662|042|H|   The dosage and treatment schedule are based on your medical||
1662|043|H|condition, weight, and response to treatment. To reduce your risk||
1662|044|H|of side effects, your doctor may prescribe other medications||
1662|045|H|(such as dexamethasone) before each treatment to help reduce side||
1662|046|H|effects. Also, your doctor may start this medication at a low||
1662|047|H|dose and gradually increase your dose.||
1662|048|H|   This medication is given by slow injection (infusion) into a||
1662|049|H|vein as directed by your doctor. A special machine (infusion||
1662|050|H|pump) is used for giving the injection, usually over 4 weeks (28||
1662|051|H|days), followed by a break (usually 2 weeks) during which you||
1662|052|H|will not be given blinatumomab. After the break, your doctor will||
1662|053|H|decide if you will be given another treatment cycle with this||
1662|054|H|medication. In later treatment cycles, your breaks may be longer||
1662|055|H|(8 weeks). Do not change the settings on the infusion pump since||
1662|056|H|you might get the wrong dose. Ask your health care professional||
1662|057|H|right away if you have any questions about the infusion pump.||
1662|058|B|||
1662|059|S|SIDE EFFECTS:  See also Warning section.||
1662|060|S|   Nausea, heartburn, constipation, shaking (tremor), swelling||
1662|061|S|ankles/feet/hands, or dizziness may occur. If any of these||
1662|062|S|effects last or get worse, tell your doctor or pharmacist||
1662|063|S|promptly.||
1662|064|S|   People using this medication may have serious side effects.||
1662|065|S|However, you have been prescribed this drug because your doctor||
1662|066|S|has judged that the benefit to you is greater than the risk of||
1662|067|S|side effects. Careful monitoring by your doctor may decrease your||
1662|068|S|risk.||
1662|069|S|   Blinatumomab sometimes causes side effects due to the rapid||
1662|070|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1662|071|S|risk, your doctor may add a medication and tell you to drink||
1662|072|S|plenty of fluids. Tell your doctor right away if you have||
1662|073|S|symptoms such as: low back/side pain (flank pain), signs of||
1662|074|S|kidney problems (such as painful urination, pink/bloody urine,||
1662|075|S|change in the amount of urine), muscle spasms/weakness.||
1662|076|S|   This medication may lower your ability to fight infections.||
1662|077|S|This may make you more likely to get a serious (rarely fatal)||
1662|078|S|infection or make any infection you have worse. Tell your doctor||
1662|079|S|right away if you have any signs of infection (such as sore||
1662|080|S|throat that doesn't go away, fever, chills).||
1662|081|S|   A very serious allergic reaction to this drug is rare.||
1662|082|S|However, get medical help right away if you notice any symptoms||
1662|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1662|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1662|085|S|breathing.||
1662|086|S|   This is not a complete list of possible side effects. If you||
1662|087|S|notice other effects not listed above, contact your doctor or||
1662|088|S|pharmacist.||
1662|089|S|   In the US -||
1662|090|S|   Call your doctor for medical advice about side effects. You||
1662|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1662|092|S|www.fda.gov/medwatch.||
1662|093|S|   In Canada - Call your doctor for medical advice about side||
1662|094|S|effects. You may report side effects to Health Canada at||
1662|095|S|1-866-234-2345.||
1662|096|B|||
1662|097|P|PRECAUTIONS:  Before using blinatumomab, tell your doctor or||
1662|098|P|pharmacist if you are allergic to it; or if you have any other||
1662|099|P|allergies. This product may contain inactive ingredients, which||
1662|100|P|can cause allergic reactions or other problems. Talk to your||
1662|101|P|pharmacist for more details.||
1662|102|P|   Before using this medication, tell your doctor or pharmacist||
1662|103|P|your medical history, especially of: bleeding/blood problems,||
1662|104|P|brain/nerve disorders, current or returning infections, seizures,||
1662|105|P|Down syndrome.||
1662|106|P|   This drug may make you dizzy, confused, or cause seizures.||
1662|107|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1662|108|P|confused. Do not drive, use machinery, or do anything that needs||
1662|109|P|alertness while you are receiving this medication. Avoid||
1662|110|P|alcoholic beverages. Talk to your doctor if you are using||
1662|111|P|marijuana (cannabis).||
1662|112|P|   Before having surgery, tell your doctor or dentist about all||
1662|113|P|the products you use (including prescription drugs,||
1662|114|P|nonprescription drugs, and herbal products).||
1662|115|P|   Blinatumomab can make you more likely to get infections or may||
1662|116|P|make current infections worse. Stay away from anyone who has an||
1662|117|P|infection that may easily spread (such as chickenpox, COVID-19,||
1662|118|P|measles, flu). Talk to your doctor if you have been exposed to an||
1662|119|P|infection or for more details.||
1662|120|P|   Tell your health care professional that you are using||
1662|121|P|blinatumomab before having any immunizations/vaccinations. Avoid||
1662|122|P|contact with people who have recently received live vaccines||
1662|123|P|(such as flu vaccine inhaled through the nose).||
1662|124|P|   To lower the chance of getting cut, bruised, or injured, use||
1662|125|P|caution with sharp objects like razors and nail cutters, and||
1662|126|P|avoid activities such as contact sports.||
1662|127|P|   Tell your doctor if you are pregnant or plan to become||
1662|128|P|pregnant. You should not become pregnant while using||
1662|129|P|blinatumomab. Blinatumomab may harm an unborn baby. Your doctor||
1662|130|P|should order a pregnancy test before you start this medication.||
1662|131|P|Ask about reliable forms of birth control while using this||
1662|132|P|medication and for 48 hours after the last dose. If you become||
1662|133|P|pregnant, talk to your doctor right away about the risks and||
1662|134|P|benefits of this medication.||
1662|135|P|   It is unknown if this medication passes into breast milk.||
1662|136|P|Because of the possible risk to the infant, breastfeeding is not||
1662|137|P|recommended while using this medication and for 48 hours after||
1662|138|P|the last dose. Consult your doctor before breastfeeding.||
1662|139|B|||
1662|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1662|141|I|medications work or increase your risk for serious side effects.||
1662|142|I|This document does not contain all possible drug interactions.||
1662|143|I|Keep a list of all the products you use (including||
1662|144|I|prescription/nonprescription drugs and herbal products) and share||
1662|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
1662|146|I|the dosage of any medicines without your doctor's approval.||
1662|147|B|||
1662|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1662|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1662|150|O|poison control center right away. US residents can call||
1662|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1662|152|B|||
1662|153|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1662|154|N|liver function) should be done while you are using this||
1662|155|N|medication. Keep all medical and lab appointments. Consult your||
1662|156|N|doctor for more details.||
1662|157|B|||
1662|158|D|MISSED DOSE:  It is important to get each dose of this medication||
1662|159|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1662|160|D|right away for a new dosing schedule.||
1662|161|B|||
1662|162|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
1662|163|R|medications away from children and pets.||
1662|164|R|   Do not flush medications down the toilet or pour them into a||
1662|165|R|drain unless instructed to do so. Properly discard this product||
1662|166|R|when it is expired or no longer needed. Consult your pharmacist||
1662|167|R|or local waste disposal company.||
1662|168|B|||
1662|169|M|MEDICAL ALERT:  Your condition can cause complications in a||
1662|170|M|medical emergency. For information about enrolling in MedicAlert,||
1662|171|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1662|172|B|||
1662|173|A|Information last revised April 2025.||
1662|174|A|Copyright(c) 2025 First Databank, Inc.||
1662|175|B|||
1663|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1663|002|Z|does NOT have all possible information about this product. This||
1663|003|Z|information does not assure that this product is safe, effective,||
1663|004|Z|or appropriate for you. This information is not individual||
1663|005|Z|medical advice and does not substitute for the advice of your||
1663|006|Z|health care professional. Always ask your health care||
1663|007|Z|professional for complete information about this product and your||
1663|008|Z|specific health needs.||
1663|009|B|||
1663|010|T|ATAZANAVIR POWDER PACKET - ORAL||
1663|011|F|(A-ta-ZAN-a-vir)||
1663|012|B|||
1663|013|C|COMMON BRAND NAME(S): Reyataz||
1663|014|B|||
1663|015|U|USES:  This form of atazanavir is used with other HIV medications||
1663|016|U|for infants and children to help control HIV infection. It helps||
1663|017|U|to decrease the amount of HIV in the body so your child's immune||
1663|018|U|system can work better. This lowers the chance of getting HIV||
1663|019|U|complications (such as new infections, cancer) and improves your||
1663|020|U|child's quality of life.||
1663|021|U|   Atazanavir belongs to a class of drugs known as protease||
1663|022|U|inhibitors. This form of atazanavir must be given with a certain||
1663|023|U|other protease inhibitor (ritonavir) to increase ("boost") the||
1663|024|U|levels of atazanavir. This helps atazanavir work better.||
1663|025|U|   Atazanavir is not a cure for HIV infection. To decrease the||
1663|026|U|risk of spreading HIV disease to others, your child should||
1663|027|U|continue to take all HIV medications exactly as prescribed by the||
1663|028|U|doctor. Do not share your child's personal items (such as||
1663|029|U|needles/syringes, toothbrushes) that may have contacted blood or||
1663|030|U|other body fluids. Consult the doctor or pharmacist for more||
1663|031|U|details.||
1663|032|B|||
1663|033|V|OTHER USES:  This section contains uses of this drug that are not||
1663|034|V|listed in the approved professional labeling for the drug but||
1663|035|V|that may be prescribed by your health care professional. Use this||
1663|036|V|drug for a condition that is listed in this section only if it||
1663|037|V|has been so prescribed by your health care professional.||
1663|038|V|   This product may also be used to lessen the risk of HIV||
1663|039|V|infection after contact with the virus (for example, due to a||
1663|040|V|needle stick). Ask your doctor for more details.||
1663|041|B|||
1663|042|H|HOW TO USE:  Read the Patient Information Leaflet and||
1663|043|H|Instructions for Use if available from your pharmacist before you||
1663|044|H|start giving atazanavir to your child and each time you get a||
1663|045|H|refill. If you have any questions, ask the doctor or pharmacist.||
1663|046|H|   This medication is taken by mouth. Give this medication to||
1663|047|H|your child as directed by the doctor, usually once daily. Open||
1663|048|H|the packet and mix its contents with food (such as applesauce,||
1663|049|H|yogurt) as directed. If your child cannot eat solid food, this||
1663|050|H|medication may be mixed with liquid (such as milk, infant||
1663|051|H|formula, or water). If your child is younger than 6 months and||
1663|052|H|cannot eat solid food or drink from a cup, mix this medication||
1663|053|H|with infant formula as directed and give it to your child using||
1663|054|H|an oral syringe. Do not use a baby bottle. Give the dose within 1||
1663|055|H|hour after mixing with food or liquid. Also, give your child's||
1663|056|H|ritonavir dose right after this medication.||
1663|057|H|   Since this medication may cause kidney problems, give plenty||
1663|058|H|of fluids during treatment to lower the risk.||
1663|059|H|   The dosage is based on your child's medical condition, weight,||
1663|060|H|response to treatment, and other medications your child may be||
1663|061|H|taking. Be sure to tell the doctor and pharmacist about all the||
1663|062|H|products your child uses (including prescription drugs,||
1663|063|H|nonprescription drugs, and herbal products).||
1663|064|H|   If your child is taking antacids or buffered forms of drugs||
1663|065|H|(such as buffered aspirin), give atazanavir at least 2 hours||
1663|066|H|before or 1 hour after these medications.||
1663|067|H|   For the best effect, take this medication at evenly spaced||
1663|068|H|times. To help you remember, take this medication at the same||
1663|069|H|time every day.||
1663|070|H|   It is very important to continue giving this medication (and||
1663|071|H|other HIV medications) exactly as prescribed by the doctor. Do||
1663|072|H|not skip any doses. Do not give more or less of this drug than||
1663|073|H|prescribed or stop giving it (or other HIV medicines) even for a||
1663|074|H|short time unless directed to do so by the doctor. Doing so may||
1663|075|H|cause the amount of virus to increase, make the infection more||
1663|076|H|difficult to treat (resistant), or worsen side effects.||
1663|077|B|||
1663|078|S|SIDE EFFECTS:  Headache or nausea may occur. If either of these||
1663|079|S|effects lasts or gets worse, tell the doctor or pharmacist||
1663|080|S|promptly.||
1663|081|S|   Remember that this medication has been prescribed because the||
1663|082|S|doctor has judged that the benefit to your child is greater than||
1663|083|S|the risk of side effects. Many people using this medication do||
1663|084|S|not have serious side effects.||
1663|085|S|   As your immune system gets stronger, it can begin to fight off||
1663|086|S|infections you already had, possibly causing disease symptoms to||
1663|087|S|come back. You could also have symptoms if your immune system||
1663|088|S|becomes overactive. This reaction may happen at any time (soon||
1663|089|S|after starting HIV treatment or many months later). Tell your||
1663|090|S|doctor right away if you have any serious symptoms, including:||
1663|091|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1663|092|S|that doesn't go away, headaches that are severe or don't go away,||
1663|093|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1663|094|S|changes, signs of infection (such as sore throat that doesn't go||
1663|095|S|away, fever, chills, non-healing skin sores), signs of an||
1663|096|S|overactive thyroid (such as irritability, nervousness, heat||
1663|097|S|intolerance, fast/pounding/irregular heartbeat).||
1663|098|S|   Tell the doctor right away if your child has any serious side||
1663|099|S|effects, including: increased thirst/urination, dizziness,||
1663|100|S|lightheadedness, signs of kidney problems (such as pain in||
1663|101|S|side/back/abdomen, painful urination, blood in the urine, change||
1663|102|S|in the amount of urine), signs of liver problems (such as||
1663|103|S|nausea/vomiting that doesn't stop, loss of appetite,||
1663|104|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1663|105|S|   Get medical help right away if your child has any very serious||
1663|106|S|side effects, including: signs of a heart attack (such as||
1663|107|S|chest/jaw/left arm pain, shortness of breath, unusual sweating).||
1663|108|S|   Changes in body fat may occur while your child is taking this||
1663|109|S|medication (such as increased fat in the upper back and stomach||
1663|110|S|areas, decreased fat in the arms and legs). The cause and||
1663|111|S|long-term effects of these changes are unknown. Discuss the risks||
1663|112|S|and benefits of treatment with the doctor, as well as the||
1663|113|S|possible use of exercise to reduce this side effect.||
1663|114|S|   Atazanavir can commonly cause a rash that is usually not||
1663|115|S|serious. However, you may not be able to tell it apart from a||
1663|116|S|rare rash that could be a sign of a severe reaction. Get medical||
1663|117|S|help right away if your child develops any rash.||
1663|118|S|   A very serious allergic reaction to this drug is rare.||
1663|119|S|However, get medical help right away if you notice any symptoms||
1663|120|S|of a serious allergic reaction, including: swollen lymph nodes,||
1663|121|S|rash, itching/swelling (especially of the face/tongue/throat),||
1663|122|S|severe dizziness, trouble breathing.||
1663|123|S|   This is not a complete list of possible side effects. If you||
1663|124|S|notice other effects not listed above, contact the doctor or||
1663|125|S|pharmacist.||
1663|126|S|   In the US -||
1663|127|S|   Call your doctor for medical advice about side effects. You||
1663|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1663|129|S|www.fda.gov/medwatch.||
1663|130|S|   In Canada - Call your doctor for medical advice about side||
1663|131|S|effects. You may report side effects to Health Canada at||
1663|132|S|1-866-234-2345.||
1663|133|B|||
1663|134|P|PRECAUTIONS:  Before taking atazanavir, tell the doctor or||
1663|135|P|pharmacist if your child is allergic to it; or if your child has||
1663|136|P|any other allergies. This product may contain inactive||
1663|137|P|ingredients, which can cause allergic reactions or other||
1663|138|P|problems. Talk to your pharmacist for more details.||
1663|139|P|   Before using this medication, tell the doctor or pharmacist||
1663|140|P|your child's medical history, especially of: liver problems||
1663|141|P|(including hepatitis B or C infections), kidney problems||
1663|142|P|(including kidney stones), heart problems (such as heart rhythm||
1663|143|P|problems, irregular heartbeat, coronary artery disease, heart||
1663|144|P|attack), a certain bleeding problem (hemophilia).||
1663|145|P|   Atazanavir may increase the level of cholesterol and fats||
1663|146|P|(triglycerides) in the blood. HIV infection can also cause this||
1663|147|P|effect. This could increase your child's risk for heart problems||
1663|148|P|such as a heart attack. Discuss the risks and benefits of||
1663|149|P|treatment with the doctor and ways to lower the risk of heart||
1663|150|P|disease. Tell the doctor if your child has heart problems or||
1663|151|P|other conditions that increase the risk of heart disease such as||
1663|152|P|high blood pressure, diabetes, or high cholesterol/triglyceride||
1663|153|P|levels.||
1663|154|P|   This medication may contain aspartame. If your child has||
1663|155|P|phenylketonuria (PKU) or any other condition that requires your||
1663|156|P|child to limit/avoid aspartame (or phenylalanine) in the diet,||
1663|157|P|ask the doctor or pharmacist about using this medication safely.||
1663|158|P|   Before having surgery, tell the doctor or dentist about all||
1663|159|P|the products your child uses (including prescription drugs,||
1663|160|P|nonprescription drugs, and herbal products).||
1663|161|P|   Atazanavir should not be given to children younger than 3||
1663|162|P|months because of the risk of very serious side effects.||
1663|163|P|   This form of atazanavir is not usually used by adults. It is||
1663|164|P|unlikely to be used during pregnancy or breastfeeding. Consult||
1663|165|P|the doctor if you have any questions about this medication.||
1663|166|B|||
1663|167|I|DRUG INTERACTIONS:  See also How to Use section.||
1663|168|I|   Drug interactions may change how medications work or increase||
1663|169|I|the risk for serious side effects. This document does not contain||
1663|170|I|all possible drug interactions. Keep a list of all the products||
1663|171|I|your child uses (including prescription/nonprescription drugs and||
1663|172|I|herbal products) and share it with the doctor and pharmacist. Do||
1663|173|I|not start, stop, or change the dosage of any medicines without||
1663|174|I|the doctor's approval.||
1663|175|I|   Some products that may interact with this drug include:||
1663|176|I|certain medications used to treat chronic hepatitis C (such as||
1663|177|I|elbasvir/grazoprevir, glecaprevir/pibrentasvir), a certain||
1663|178|I|combination HIV medication||
1663|179|I|(elvitegravir/cobicistat/emtricitabine/tenofovir), nevirapine,||
1663|180|I|orlistat.||
1663|181|I|   Atazanavir can slow down the removal of other medications from||
1663|182|I|your child's body, which may affect how they work. Examples of||
1663|183|I|affected drugs include certain alpha blockers (such as alfuzosin,||
1663|184|I|silodosin), certain benzodiazepines (midazolam, triazolam), ergot||
1663|185|I|alkaloids (such as dihydroergotamine, ergotamine), irinotecan,||
1663|186|I|lomitapide, pimozide, a certain drug to treat erectile||
1663|187|I|dysfunction-ED or pulmonary hypertension (sildenafil), certain||
1663|188|I|"statin" cholesterol drugs (lovastatin, simvastatin), salmeterol,||
1663|189|I|among others.||
1663|190|I|   Other medications can affect the removal of atazanavir from||
1663|191|I|your child's body, which may affect how atazanavir works.||
1663|192|I|Examples include apalutamide, bosentan, efavirenz, etravirine,||
1663|193|I|lumacaftor, certain rifamycins (such as rifampin, rifapentine),||
1663|194|I|certain drugs used to treat seizures (such as carbamazepine,||
1663|195|I|phenobarbital, phenytoin, primidone), St. John's wort, among||
1663|196|I|others.||
1663|197|I|   Prescription and nonprescription drugs to treat heartburn,||
1663|198|I|indigestion, or ulcers (including H2 blockers such as famotidine,||
1663|199|I|proton pump inhibitors such as lansoprazole/omeprazole) reduce||
1663|200|I|stomach acid and decrease the absorption of atazanavir. This may||
1663|201|I|prevent atazanavir from working well. Ask the doctor or||
1663|202|I|pharmacist how to use these medications safely.||
1663|203|I|   If you are breastfeeding your child, ask the doctor if any||
1663|204|I|medications that you are using may pass into the breast milk and||
1663|205|I|interact with this medication.||
1663|206|B|||
1663|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1663|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1663|209|O|poison control center right away. US residents can call||
1663|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1663|211|O|Symptoms of overdose may include: severe dizziness,||
1663|212|O|lightheadedness.||
1663|213|B|||
1663|214|N|NOTES:  Do not share this medication with others.||
1663|215|N|   Lab and/or medical tests (such as viral load, T-cell counts,||
1663|216|N|kidney/liver function, cholesterol/triglyceride levels, blood||
1663|217|N|sugar levels) should be done while your child is taking this||
1663|218|N|medication. Keep all medical and lab appointments. Consult your||
1663|219|N|doctor for more details.||
1663|220|B|||
1663|221|D|MISSED DOSE:  If you miss a dose, give it as soon as you||
1663|222|D|remember. If it is near the time of the next dose, skip the||
1663|223|D|missed dose. Give the next dose at the regular time. Do not||
1663|224|D|double the dose to catch up.||
1663|225|B|||
1663|226|R|STORAGE:  Store at room temperature away from light and moisture.||
1663|227|R|Do not open the packet until you are ready to use the medication.||
1663|228|R|Do not store in the bathroom. Keep all medications away from||
1663|229|R|children and pets.||
1663|230|R|   After mixing, this medication may be stored at room||
1663|231|R|temperature for up to 1 hour.||
1663|232|R|   Do not flush medications down the toilet or pour them into a||
1663|233|R|drain unless instructed to do so. Properly discard this product||
1663|234|R|when it is expired or no longer needed. Consult your pharmacist||
1663|235|R|or local waste disposal company.||
1663|236|B|||
1663|237|A|Information last revised April 2025.||
1663|238|A|Copyright(c) 2025 First Databank, Inc.||
1663|239|B|||
1664|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1664|002|Z|does NOT have all possible information about this product. This||
1664|003|Z|information does not assure that this product is safe, effective,||
1664|004|Z|or appropriate for you. This information is not individual||
1664|005|Z|medical advice and does not substitute for the advice of your||
1664|006|Z|health care professional. Always ask your health care||
1664|007|Z|professional for complete information about this product and your||
1664|008|Z|specific health needs.||
1664|009|B|||
1664|010|T|HYDROCODONE EXTENDED-RELEASE TABLET - ORAL||
1664|011|F|(HYE-droe-KOE-done)||
1664|012|B|||
1664|013|C|COMMON BRAND NAME(S): Hysingla ER||
1664|014|B|||
1664|015|W|WARNING:  Hydrocodone has a risk for abuse and addiction, which||
1664|016|W|can lead to overdose and death. Hydrocodone may also cause||
1664|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
1664|018|W|your doctor should have you take the smallest dose of hydrocodone||
1664|019|W|that works, and take it for the shortest possible time. See also||
1664|020|W|How to Use section for more information about addiction.||
1664|021|W|   Ask your doctor or pharmacist if you should have medication||
1664|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1664|023|W|Teach your family or household members about the signs of an||
1664|024|W|opioid overdose and how to treat it.||
1664|025|W|   The risk for severe breathing problems is higher when you||
1664|026|W|start this medication and after a dose increase, or if you take||
1664|027|W|the wrong dose/strength. Taking this medication with alcohol or||
1664|028|W|other drugs that can cause drowsiness or breathing problems may||
1664|029|W|cause very serious side effects, including death. Also, other||
1664|030|W|medications can affect the removal of hydrocodone from your body,||
1664|031|W|which may affect how hydrocodone works. Be sure you know how to||
1664|032|W|take hydrocodone and what other drugs you should avoid taking||
1664|033|W|with it. See also Drug Interactions section. Get medical help||
1664|034|W|right away if any of these very serious side effects occur:||
1664|035|W|slow/shallow breathing, unusual lightheadedness, severe||
1664|036|W|drowsiness/dizziness, difficulty waking up.||
1664|037|W|   Do not crush, chew, or dissolve this medication. Taking||
1664|038|W|crushed, chewed, or dissolved forms of extended-release||
1664|039|W|hydrocodone could cause a fatal overdose.||
1664|040|W|   Before using this medication, women of childbearing age should||
1664|041|W|talk with their doctor(s) about the risks and benefits. Tell your||
1664|042|W|doctor if you are pregnant or if you plan to become pregnant.||
1664|043|W|During pregnancy, this medication should be used only when||
1664|044|W|clearly needed. It may slightly increase the risk of birth||
1664|045|W|defects if used during the first two months of pregnancy. Also,||
1664|046|W|using it for a long time or in high doses near the expected||
1664|047|W|delivery date may harm the unborn baby. To lessen the risk, take||
1664|048|W|the smallest effective dose for the shortest possible time.||
1664|049|W|Babies born to mothers who use this drug for a long time may||
1664|050|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1664|051|W|doctor right away if you notice any symptoms in your newborn baby||
1664|052|W|such as nonstop crying, slow/shallow breathing, irritability,||
1664|053|W|shaking, vomiting, diarrhea, poor feeding, or difficulty gaining||
1664|054|W|weight.||
1664|055|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1664|056|W|or abuse. If someone accidentally swallows this drug, get medical||
1664|057|W|help right away.||
1664|058|B|||
1664|059|U|USES:  Hydrocodone is used to help relieve severe ongoing pain.||
1664|060|U|Hydrocodone belongs to a class of drugs known as opioid||
1664|061|U|analgesics. It works in the brain to change how your body feels||
1664|062|U|and responds to pain.||
1664|063|U|   Do not use the extended-release form of hydrocodone to relieve||
1664|064|U|pain that is mild or that will go away in a few days. This||
1664|065|U|medication is not for occasional ("as needed") use.||
1664|066|B|||
1664|067|H|HOW TO USE:  Read the Medication Guide provided by your||
1664|068|H|pharmacist before you start taking hydrocodone and each time you||
1664|069|H|get a refill. If you have any questions, ask your doctor or||
1664|070|H|pharmacist.||
1664|071|H|   Take this medication on a regular schedule as directed by your||
1664|072|H|doctor, not as needed for sudden (breakthrough) pain. Take this||
1664|073|H|medication by mouth as directed by your doctor, usually once||
1664|074|H|daily (24 hours apart). Do not pre-soak, lick, or otherwise wet||
1664|075|H|the tablet before placing it in your mouth, since it may make it||
1664|076|H|harder to swallow the tablet. If your dose is for more than one||
1664|077|H|tablet, you should take one tablet at a time. Take each tablet||
1664|078|H|with enough water to make sure you completely swallow it right||
1664|079|H|after placing it in your mouth.||
1664|080|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1664|081|H|Doing so can release all of the drug at once, increasing the risk||
1664|082|H|of side effects.||
1664|083|H|   You may take this drug with or without food. If you have||
1664|084|H|nausea, it may help to take this drug with food. Ask your doctor||
1664|085|H|or pharmacist about other ways to decrease nausea (such as lying||
1664|086|H|down for 1 to 2 hours with as little head movement as possible).||
1664|087|H|   The dosage is based on your medical condition and response to||
1664|088|H|treatment. Do not increase your dose or use this drug more often||
1664|089|H|or for longer than prescribed. Your condition will not improve||
1664|090|H|any faster, and your risk of side effects will increase. Properly||
1664|091|H|stop the medication when so directed.||
1664|092|H|   Pain medications work best if they are used as the first signs||
1664|093|H|of pain occur. If you wait until the pain has worsened, the||
1664|094|H|medication may not work as well.||
1664|095|H|   Before you start using this medication, ask your doctor or||
1664|096|H|pharmacist if you should stop or change how you use your other||
1664|097|H|opioid medication(s). Other pain relievers (such as||
1664|098|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1664|099|H|or pharmacist about using hydrocodone safely with other drugs.||
1664|100|H|   Suddenly stopping this medication may cause withdrawal,||
1664|101|H|especially if you have used it for a long time or in high doses.||
1664|102|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1664|103|H|Tell your doctor or pharmacist right away if you have any||
1664|104|H|withdrawal symptoms such as restlessness, mental/mood changes||
1664|105|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1664|106|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1664|107|H|aches, or sudden changes in behavior.||
1664|108|H|   When this medication is used for a long time, it may not work||
1664|109|H|as well. Talk with your doctor if this medication stops working||
1664|110|H|well.||
1664|111|H|   Though it helps many people, this medication may sometimes||
1664|112|H|cause addiction. This risk may be higher if you have a||
1664|113|H|mental/mood disorder or a substance use disorder (such as overuse||
1664|114|H|of or addiction to drugs/alcohol). Take this medication exactly||
1664|115|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1664|116|H|pharmacist for more details.||
1664|117|H|   Tell your doctor if your pain does not get better or if it||
1664|118|H|gets worse, or if you have any new pain.||
1664|119|B|||
1664|120|S|SIDE EFFECTS:  See also Warning section.||
1664|121|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
1664|122|S|drowsiness may occur. Some of these side effects may decrease||
1664|123|S|after you have been using this medication for a while. If any of||
1664|124|S|these effects last or get worse, tell your doctor or pharmacist||
1664|125|S|promptly.||
1664|126|S|   To prevent constipation, eat dietary fiber, drink enough||
1664|127|S|water, and exercise. You may also need to take a laxative. Ask||
1664|128|S|your pharmacist which type of laxative is right for you.||
1664|129|S|   To reduce the risk of dizziness and lightheadedness, get up||
1664|130|S|slowly when rising from a sitting or lying position.||
1664|131|S|   Remember that this medication has been prescribed because your||
1664|132|S|doctor has judged that the benefit to you is greater than the||
1664|133|S|risk of side effects. Many people using this medication do not||
1664|134|S|have serious side effects.||
1664|135|S|   Tell your doctor right away if you have any serious side||
1664|136|S|effects, including: interrupted breathing during sleep (sleep||
1664|137|S|apnea), mental/mood changes (such as agitation, confusion,||
1664|138|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
1664|139|S|signs of your adrenal glands not working well (such as loss of||
1664|140|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
1664|141|S|   Get medical help right away if you have any very serious side||
1664|142|S|effects, including: fainting, fast/irregular heartbeat, severe||
1664|143|S|dizziness, seizure, slow/shallow breathing, severe||
1664|144|S|drowsiness/difficulty waking up.||
1664|145|S|   A very serious allergic reaction to this drug is rare.||
1664|146|S|However, get medical help right away if you notice any symptoms||
1664|147|S|of a serious allergic reaction, including: rash, itching/swelling||
1664|148|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1664|149|S|breathing.||
1664|150|S|   This is not a complete list of possible side effects. If you||
1664|151|S|notice other effects not listed above, contact your doctor or||
1664|152|S|pharmacist.||
1664|153|S|   In the US -||
1664|154|S|   Call your doctor for medical advice about side effects. You||
1664|155|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1664|156|S|www.fda.gov/medwatch.||
1664|157|S|   In Canada - Call your doctor for medical advice about side||
1664|158|S|effects. You may report side effects to Health Canada at||
1664|159|S|1-866-234-2345.||
1664|160|B|||
1664|161|P|PRECAUTIONS:  Before taking hydrocodone, tell your doctor or||
1664|162|P|pharmacist if you are allergic to it; or to other opioids (such||
1664|163|P|as benzhydrocodone, codeine, hydromorphone); or if you have any||
1664|164|P|other allergies. This product may contain inactive ingredients,||
1664|165|P|which can cause allergic reactions or other problems. Talk to||
1664|166|P|your pharmacist for more details.||
1664|167|P|   Before using this medication, tell your doctor or pharmacist||
1664|168|P|your medical history, especially of: brain disorders (such as||
1664|169|P|head injury, tumor, seizures), breathing problems (such as||
1664|170|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1664|171|P|gallbladder disease, kidney disease, liver disease, mental/mood||
1664|172|P|disorders (such as confusion, depression, thoughts of suicide),||
1664|173|P|personal or family history of a substance use disorder (such as||
1664|174|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
1664|175|P|problems (such as blockage, constipation, diarrhea due to||
1664|176|P|infection, paralytic ileus), disease of the pancreas||
1664|177|P|(pancreatitis), difficulty urinating (such as due to enlarged||
1664|178|P|prostate), trouble swallowing.||
1664|179|P|   Hydrocodone may cause a condition that affects the heart||
1664|180|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1664|181|P|serious (rarely fatal) fast/irregular heartbeat and other||
1664|182|P|symptoms (such as severe dizziness, fainting) that need medical||
1664|183|P|attention right away.||
1664|184|P|   The risk of QT prolongation may be increased if you have||
1664|185|P|certain medical conditions or are taking other drugs that may||
1664|186|P|cause QT prolongation. Before using hydrocodone, tell your doctor||
1664|187|P|or pharmacist of all the drugs you take and if you have any of||
1664|188|P|the following conditions: certain heart problems (heart failure,||
1664|189|P|slow heartbeat, QT prolongation in the EKG), family history of||
1664|190|P|certain heart problems (QT prolongation in the EKG, sudden||
1664|191|P|cardiac death).||
1664|192|P|   Low levels of potassium or magnesium in the blood may also||
1664|193|P|increase your risk of QT prolongation. This risk may increase if||
1664|194|P|you use certain drugs (such as diuretics/"water pills") or if you||
1664|195|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1664|196|P|Talk to your doctor about using hydrocodone safely.||
1664|197|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1664|198|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1664|199|P|machinery, or do anything that needs alertness until you can do||
1664|200|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1664|201|P|are using marijuana (cannabis).||
1664|202|P|   Before having surgery, tell your doctor or dentist about all||
1664|203|P|the products you use (including prescription drugs,||
1664|204|P|nonprescription drugs, and herbal products).||
1664|205|P|   Children may be more sensitive to the side effects of this||
1664|206|P|drug, especially slow/shallow breathing, trouble swallowing, and||
1664|207|P|choking.||
1664|208|P|   Older adults may be more sensitive to the side effects of this||
1664|209|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
1664|210|P|breathing, QT prolongation (see above).||
1664|211|P|   During pregnancy, this medication should be used only when||
1664|212|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1664|213|P|benefits with your doctor. (See also Warning section.)||
1664|214|P|   This drug passes into breast milk and may have undesirable||
1664|215|P|effects on a nursing infant. Tell the doctor right away if your||
1664|216|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1664|217|P|breathing. Consult your doctor before breastfeeding.||
1664|218|B|||
1664|219|I|DRUG INTERACTIONS:  See also Warning section.||
1664|220|I|   Drug interactions may change how your medications work or||
1664|221|I|increase your risk for serious side effects. This document does||
1664|222|I|not contain all possible drug interactions. Keep a list of all||
1664|223|I|the products you use (including prescription/nonprescription||
1664|224|I|drugs and herbal products) and share it with your doctor and||
1664|225|I|pharmacist. Do not start, stop, or change the dosage of any||
1664|226|I|medicines without your doctor's approval.||
1664|227|I|   Some products that may interact with this drug are: certain||
1664|228|I|pain medications (mixed opioid agonist-antagonists such as||
1664|229|I|butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.||
1664|230|I|   Other medications can affect the removal of hydrocodone from||
1664|231|I|your body, which may affect how hydrocodone works. Examples||
1664|232|I|include azole antifungals (such as ketoconazole), macrolide||
1664|233|I|antibiotics (such as erythromycin), mifepristone, HIV medications||
1664|234|I|(such as tipranavir), rifamycins (such as rifabutin, rifampin),||
1664|235|I|ritonavir, certain drugs used to treat seizures (such as||
1664|236|I|carbamazepine, phenytoin), among others.||
1664|237|I|   The risk of serious side effects (such as slow/shallow||
1664|238|I|breathing, severe drowsiness/dizziness) may be increased if this||
1664|239|I|medication is taken with other products that may also cause||
1664|240|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1664|241|I|if you are taking other products such as other opioid pain or||
1664|242|I|cough relievers (such as codeine, oxycodone), alcohol, marijuana||
1664|243|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1664|244|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1664|245|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1664|246|I|diphenhydramine).||
1664|247|I|   Check the labels on all your medicines (such as allergy or||
1664|248|I|cough-and-cold products) because they may contain ingredients||
1664|249|I|that cause drowsiness. Ask your pharmacist about using those||
1664|250|I|products safely.||
1664|251|I|   This medication may interfere with certain lab tests (such as||
1664|252|I|amylase/lipase levels), possibly causing false test results. Make||
1664|253|I|sure lab personnel and all your doctors know you use this drug.||
1664|254|B|||
1664|255|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1664|256|O|as passing out or trouble breathing, give them naloxone or||
1664|257|O|nalmefene if available, then call 911. If the person is awake and||
1664|258|O|has no symptoms, call a poison control center right away. US||
1664|259|O|residents can call 1-800-222-1222. Canada residents can call||
1664|260|O|1-844-764-7669. Symptoms of overdose may include: slow breathing,||
1664|261|O|slow heartbeat, coma.||
1664|262|B|||
1664|263|N|NOTES:  Do not share this medication with others. Sharing it is||
1664|264|N|against the law.||
1664|265|N|   This medication has been prescribed for your current condition||
1664|266|N|only. Do not use it later for another condition unless your||
1664|267|N|doctor directs you to do so. A different medication may be||
1664|268|N|necessary in that case.||
1664|269|B|||
1664|270|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1664|271|D|next dose at the regular time. Do not double the dose to catch||
1664|272|D|up.||
1664|273|B|||
1664|274|R|STORAGE:  Store at room temperature away from light and moisture.||
1664|275|R|Do not store in the bathroom. Keep all medications away from||
1664|276|R|children and pets. See also Warning section.||
1664|277|R|   Do not flush medications down the toilet or pour them into a||
1664|278|R|drain unless instructed to do so. Properly discard this product||
1664|279|R|when it is expired or no longer needed. For more details, read||
1664|280|R|the Medication Guide, or consult your pharmacist or local waste||
1664|281|R|disposal company.||
1664|282|B|||
1664|283|A|Information last revised August 2025.||
1664|284|A|Copyright(c) 2025 First Databank, Inc.||
1664|285|B|||
1665|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1665|002|Z|does NOT have all possible information about this product. This||
1665|003|Z|information does not assure that this product is safe, effective,||
1665|004|Z|or appropriate for you. This information is not individual||
1665|005|Z|medical advice and does not substitute for the advice of your||
1665|006|Z|health care professional. Always ask your health care||
1665|007|Z|professional for complete information about this product and your||
1665|008|Z|specific health needs.||
1665|009|B|||
1665|010|T|MOMETASONE HFA INHALER - ORAL INHALATION||
1665|011|F|(moe-MET-a-sone)||
1665|012|B|||
1665|013|C|COMMON BRAND NAME(S): Asmanex HFA||
1665|014|B|||
1665|015|U|USES:  Mometasone is used to control and prevent symptoms (such||
1665|016|U|as wheezing and shortness of breath) caused by asthma.||
1665|017|U|Controlling symptoms of asthma helps you maintain your normal||
1665|018|U|activities and decreases time lost from work or school.||
1665|019|U|Mometasone belongs to a class of drugs known as corticosteroids.||
1665|020|U|It works by reducing swelling (inflammation) of the airways in||
1665|021|U|the lungs to make breathing easier.||
1665|022|U|   This medication must be used regularly to be effective. It||
1665|023|U|does not work right away and should not be used to relieve sudden||
1665|024|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
1665|025|U|inhaler (such as albuterol, also called salbutamol in some||
1665|026|U|countries) as prescribed.||
1665|027|B|||
1665|028|V|OTHER USES:  This section contains uses of this drug that are not||
1665|029|V|listed in the approved professional labeling for the drug but||
1665|030|V|that may be prescribed by your health care professional. Use this||
1665|031|V|drug for a condition that is listed in this section only if it||
1665|032|V|has been so prescribed by your health care professional.||
1665|033|V|   This drug may also be used to control symptoms (such as||
1665|034|V|wheezing and shortness of breath) caused by ongoing lung disease||
1665|035|V|(chronic obstructive pulmonary disease-COPD, which includes||
1665|036|V|chronic bronchitis and emphysema).||
1665|037|B|||
1665|038|H|HOW TO USE:  Read the Patient Information Leaflet and the product||
1665|039|H|instructions provided by your pharmacist before you start using||
1665|040|H|this medication and each time you get a refill. If you have any||
1665|041|H|questions, ask your doctor or pharmacist.||
1665|042|H|   Follow the instructions for priming the inhaler if you are||
1665|043|H|using it for the first time or if you have not used it for more||
1665|044|H|than 5 days. When priming the inhaler, make sure to spray away||
1665|045|H|from your face so that you do not get the medication into your||
1665|046|H|eyes.||
1665|047|H|   Shake the inhaler well before each use. Inhale this medication||
1665|048|H|by mouth as directed by your doctor, usually twice a day (morning||
1665|049|H|and evening). The dosage is based on your medical condition and||
1665|050|H|response to treatment.||
1665|051|H|   If two inhalations/puffs are prescribed, wait at least one||
1665|052|H|minute between them. If you are using other inhalers at the same||
1665|053|H|time, wait at least 1 minute between the use of each medication,||
1665|054|H|and use this drug (the corticosteroid) last.||
1665|055|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
1665|056|H|from developing, gargle, rinse your mouth with water and spit out||
1665|057|H|after each use. Do not swallow the rinse water.||
1665|058|H|   Clean the mouthpiece once a week with a dry tissue. Do not wet||
1665|059|H|the inhaler. Do not take the inhaler apart.||
1665|060|H|   Use this medication regularly to get the most benefit from it.||
1665|061|H|This medication works best if used at evenly spaced intervals. To||
1665|062|H|help you remember, use it at the same times each day. Do not||
1665|063|H|increase your dose, use this drug more often, or stop using it||
1665|064|H|without first consulting your doctor.||
1665|065|H|   If you are regularly taking a different corticosteroid by||
1665|066|H|mouth (such as prednisone), you should not stop taking it unless||
1665|067|H|directed by your doctor. Some conditions (such as asthma,||
1665|068|H|allergies) may become worse when the drug is suddenly stopped. If||
1665|069|H|you suddenly stop taking the drug, you may also have withdrawal||
1665|070|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
1665|071|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
1665|072|H|doctor may slowly lower the dose of your old medication after you||
1665|073|H|begin using mometasone. Tell your doctor or pharmacist right away||
1665|074|H|if you have withdrawal. See also Precautions section.||
1665|075|H|   It may take 1 to 2 weeks before you get the full benefit of||
1665|076|H|this drug. Tell your doctor if your symptoms do not get better or||
1665|077|H|if they get worse.||
1665|078|H|   Learn which of your inhalers you should use every day||
1665|079|H|(controller drugs) and which you should use if your breathing||
1665|080|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
1665|081|H|time what you should do if you have new or worsening cough or||
1665|082|H|shortness of breath, wheezing, increased sputum, worsening peak||
1665|083|H|flow meter readings, waking up at night with trouble breathing,||
1665|084|H|if you use your quick-relief inhaler more often (more than 2 days||
1665|085|H|a week), or if your quick-relief inhaler does not seem to be||
1665|086|H|working well. Learn when you can treat sudden breathing problems||
1665|087|H|by yourself and when you must get medical help right away.||
1665|088|B|||
1665|089|S|SIDE EFFECTS:  See also Precautions section.||
1665|090|S|   Dry/irritated throat, hoarseness, or coughing may occur as||
1665|091|S|your body adjusts to the medication. If any of these effects last||
1665|092|S|or get worse, tell your doctor or pharmacist promptly.||
1665|093|S|   Remember that this medication has been prescribed because your||
1665|094|S|doctor has judged that the benefit to you is greater than the||
1665|095|S|risk of side effects. Many people using this medication do not||
1665|096|S|have serious side effects.||
1665|097|S|   Tell your doctor right away if you have any serious side||
1665|098|S|effects, including: white patches in your mouth or on your||
1665|099|S|tongue, signs of infection (such as sore throat that doesn't go||
1665|100|S|away, fever, chills), mental/mood changes (such as depression,||
1665|101|S|mood swings, agitation), vision problems, increased||
1665|102|S|thirst/urination, easy bruising/bleeding, bone pain.||
1665|103|S|   Rarely, this medication may cause sudden severe||
1665|104|S|wheezing/trouble breathing immediately after you use it. If this||
1665|105|S|occurs, use your quick-relief inhaler and get medical help right||
1665|106|S|away.||
1665|107|S|   A very serious allergic reaction to this drug is rare.||
1665|108|S|However, get medical help right away if you notice any symptoms||
1665|109|S|of a serious allergic reaction, including: rash, itching/swelling||
1665|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1665|111|S|breathing.||
1665|112|S|   This is not a complete list of possible side effects. If you||
1665|113|S|notice other effects not listed above, contact your doctor or||
1665|114|S|pharmacist.||
1665|115|S|   In the US -||
1665|116|S|   Call your doctor for medical advice about side effects. You||
1665|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1665|118|S|www.fda.gov/medwatch.||
1665|119|S|   In Canada - Call your doctor for medical advice about side||
1665|120|S|effects. You may report side effects to Health Canada at||
1665|121|S|1-866-234-2345.||
1665|122|B|||
1665|123|P|PRECAUTIONS:  Before using mometasone, tell your doctor or||
1665|124|P|pharmacist if you are allergic to it; or if you have any other||
1665|125|P|allergies. This product may contain inactive ingredients, which||
1665|126|P|can cause allergic reactions or other problems. Talk to your||
1665|127|P|pharmacist for more details.||
1665|128|P|   Before using this medication, tell your doctor or pharmacist||
1665|129|P|your medical history, especially of: current/past infections||
1665|130|P|(such as tuberculosis, herpes), bone loss (osteoporosis), eye||
1665|131|P|problems (such as cataracts, glaucoma).||
1665|132|P|   If you have switched from a corticosteroid taken by mouth||
1665|133|P|(such as prednisone tablets) to this inhaler within the past 12||
1665|134|P|months, or if you have been using this product in||
1665|135|P|higher-than-usual doses for a long time, it may be more difficult||
1665|136|P|for your body to respond to physical stress. Before having||
1665|137|P|surgery or emergency treatment, or if you get a serious||
1665|138|P|illness/injury, tell your doctor or dentist that you are using||
1665|139|P|this medication or have used a corticosteroid taken by mouth||
1665|140|P|within the past 12 months. Tell your doctor right away if you||
1665|141|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
1665|142|P|card or medical ID bracelet that says you use (or have used)||
1665|143|P|corticosteroid medications.||
1665|144|P|   Before having surgery, tell your doctor or dentist about all||
1665|145|P|the products you use (including prescription drugs,||
1665|146|P|nonprescription drugs, and herbal products).||
1665|147|P|   This medication may mask signs of infection. It can make you||
1665|148|P|more likely to get infections or may make current infections||
1665|149|P|worse. Stay away from anyone who has an infection that may easily||
1665|150|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1665|151|P|doctor if you have been exposed to an infection or for more||
1665|152|P|details.||
1665|153|P|   This medication may temporarily slow down a child's growth if||
1665|154|P|used for a long time. However, poorly controlled asthma can also||
1665|155|P|slow down growth. See the doctor regularly so your child's height||
1665|156|P|can be checked.||
1665|157|P|   During pregnancy, this medication should be used only when||
1665|158|P|clearly needed. Discuss the risks and benefits with your doctor.||
1665|159|P|   It is unknown if this drug passes into breast milk. Consult||
1665|160|P|your doctor before breastfeeding.||
1665|161|B|||
1665|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1665|163|I|medications work or increase your risk for serious side effects.||
1665|164|I|This document does not contain all possible drug interactions.||
1665|165|I|Keep a list of all the products you use (including||
1665|166|I|prescription/nonprescription drugs and herbal products) and share||
1665|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
1665|168|I|the dosage of any medicines without your doctor's approval.||
1665|169|I|   A product that may interact with this drug is: desmopressin.||
1665|170|B|||
1665|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1665|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1665|173|O|poison control center right away. US residents can call||
1665|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1665|175|B|||
1665|176|N|NOTES:  Do not share this medication with others.||
1665|177|N|   Lab and/or medical tests (such as cortisol levels, lung||
1665|178|N|function, eye exams, bone density tests) should be done while you||
1665|179|N|are using this medication. Keep all medical and lab appointments.||
1665|180|N|Consult your doctor for more details.||
1665|181|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
1665|182|N|mold that can worsen breathing problems. Because the flu virus||
1665|183|N|can also worsen breathing problems, ask your doctor or pharmacist||
1665|184|N|if you should have a flu shot every year.||
1665|185|N|   This medication may cause bone loss (osteoporosis) in adults||
1665|186|N|when used for a long time. Lifestyle changes that may help reduce||
1665|187|N|the risk of bone problems include doing weight-bearing exercise,||
1665|188|N|stopping smoking, limiting alcohol, and getting enough calcium||
1665|189|N|and vitamin D. Talk to your doctor for more details.||
1665|190|B|||
1665|191|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1665|192|D|If it is near the time of the next dose, skip the missed dose.||
1665|193|D|Use your next dose at the regular time. Do not double the dose to||
1665|194|D|catch up.||
1665|195|B|||
1665|196|R|STORAGE:  Store at room temperature. Do not puncture or expose||
1665|197|R|this medication to high heat or open flame. Keep all medications||
1665|198|R|away from children and pets.||
1665|199|R|   Do not flush medications down the toilet or pour them into a||
1665|200|R|drain unless instructed to do so. Properly discard this product||
1665|201|R|when it is expired or no longer needed. Consult your pharmacist||
1665|202|R|or local waste disposal company.||
1665|203|B|||
1665|204|M|MEDICAL ALERT:  Your condition can cause complications in a||
1665|205|M|medical emergency. For information about enrolling in MedicAlert,||
1665|206|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1665|207|B|||
1665|208|A|Information last revised September 2025.||
1665|209|A|Copyright(c) 2025 First Databank, Inc.||
1665|210|B|||
1667|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1667|002|Z|does NOT have all possible information about this product. This||
1667|003|Z|information does not assure that this product is safe, effective,||
1667|004|Z|or appropriate for you. This information is not individual||
1667|005|Z|medical advice and does not substitute for the advice of your||
1667|006|Z|health care professional. Always ask your health care||
1667|007|Z|professional for complete information about this product and your||
1667|008|Z|specific health needs.||
1667|009|B|||
1667|010|T|PERAMIVIR - INJECTION||
1667|011|F|(per-AM-i-vir)||
1667|012|B|||
1667|013|C|COMMON BRAND NAME(S): Rapivab||
1667|014|B|||
1667|015|U|USES:  Peramivir is used to treat symptoms caused by the flu||
1667|016|U|virus (influenza) if you have had symptoms for 2 days or less. It||
1667|017|U|helps make the symptoms (such as stuffy nose, cough, sore throat,||
1667|018|U|fever/chills, aches, tiredness) less severe and shortens the||
1667|019|U|recovery time by about 1 to 2 days.||
1667|020|U|   This medication works by stopping the flu virus from growing.||
1667|021|U|It is not a substitute for the flu vaccine. (See also Notes||
1667|022|U|section.)||
1667|023|B|||
1667|024|H|HOW TO USE:  This medication is given as a single dose as||
1667|025|H|directed by your doctor. It is given slowly into a vein, usually||
1667|026|H|over 15 to 30 minutes. The dosage is based on your medical||
1667|027|H|condition, age, and response to treatment. Children's dosage is||
1667|028|H|also based on weight.||
1667|029|H|   Tell your doctor if your condition lasts or gets worse, or if||
1667|030|H|new symptoms appear.||
1667|031|B|||
1667|032|S|SIDE EFFECTS:  This drug usually has no side effects. If you have||
1667|033|S|any unusual effects, contact your doctor or pharmacist promptly.||
1667|034|S|   Remember that this medication has been prescribed because your||
1667|035|S|doctor has judged that the benefit to you is greater than the||
1667|036|S|risk of side effects. Many people using this medication do not||
1667|037|S|have serious side effects.||
1667|038|S|   The flu itself or peramivir may rarely cause serious||
1667|039|S|mental/mood changes. This may be more likely in children. Tell||
1667|040|S|your doctor right away of any signs of unusual behavior,||
1667|041|S|including: confusion, hallucinations, agitation, self-injury.||
1667|042|S|   A very serious allergic reaction to this drug is rare.||
1667|043|S|However, get medical help right away if you notice any symptoms||
1667|044|S|of a serious allergic reaction, including: rash, itching/swelling||
1667|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1667|046|S|breathing.||
1667|047|S|   This is not a complete list of possible side effects. If you||
1667|048|S|notice other effects not listed above, contact your doctor or||
1667|049|S|pharmacist.||
1667|050|S|   In the US -||
1667|051|S|   Call your doctor for medical advice about side effects. You||
1667|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1667|053|S|www.fda.gov/medwatch.||
1667|054|S|   In Canada - Call your doctor for medical advice about side||
1667|055|S|effects. You may report side effects to Health Canada at||
1667|056|S|1-866-234-2345.||
1667|057|B|||
1667|058|P|PRECAUTIONS:  Before using peramivir, tell your doctor or||
1667|059|P|pharmacist if you are allergic to it; or if you have any other||
1667|060|P|allergies. This product may contain inactive ingredients, which||
1667|061|P|can cause allergic reactions or other problems. Talk to your||
1667|062|P|pharmacist for more details.||
1667|063|P|   Before using this medication, tell your doctor or pharmacist||
1667|064|P|your medical history, especially of: kidney disease (including||
1667|065|P|dialysis treatment).||
1667|066|P|   Before having surgery, tell your doctor or dentist about all||
1667|067|P|the products you use (including prescription drugs,||
1667|068|P|nonprescription drugs, and herbal products).||
1667|069|P|   During pregnancy, this medication should be used only when||
1667|070|P|clearly needed. Discuss the risks and benefits with your doctor.||
1667|071|P|   It is unknown if this drug passes into breast milk. Consult||
1667|072|P|your doctor before breastfeeding.||
1667|073|B|||
1667|074|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1667|075|I|medications work or increase your risk for serious side effects.||
1667|076|I|This document does not contain all possible drug interactions.||
1667|077|I|Keep a list of all the products you use (including||
1667|078|I|prescription/nonprescription drugs and herbal products) and share||
1667|079|I|it with your doctor and pharmacist. Do not start, stop, or change||
1667|080|I|the dosage of any medicines without your doctor's approval.||
1667|081|I|   Tell your doctor if you have received flu vaccine in the nose||
1667|082|I|within 2 weeks before treatment with this medication. This||
1667|083|I|medication may lower your protection from flu vaccine given in||
1667|084|I|the nose. Wait at least 2 days after ending treatment with this||
1667|085|I|medication before receiving flu vaccine given in the nose.||
1667|086|B|||
1667|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1667|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1667|089|O|poison control center right away. US residents can call||
1667|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1667|091|B|||
1667|092|N|NOTES:  Do not share this medication with others.||
1667|093|N|   This medication is not a substitute for the flu vaccine. Talk||
1667|094|N|with your doctor about the risks and important benefits of||
1667|095|N|getting a yearly flu shot.||
1667|096|B|||
1667|097|D|MISSED DOSE:  Not applicable.||
1667|098|B|||
1667|099|R|STORAGE:  Not applicable. This medication is given in a hospital||
1667|100|R|or clinic and will not be stored at home.||
1667|101|B|||
1667|102|A|Information last revised May 2024.||
1667|103|A|Copyright(c) 2025 First Databank, Inc.||
1667|104|B|||
1668|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1668|002|Z|does NOT have all possible information about this product. This||
1668|003|Z|information does not assure that this product is safe, effective,||
1668|004|Z|or appropriate for you. This information is not individual||
1668|005|Z|medical advice and does not substitute for the advice of your||
1668|006|Z|health care professional. Always ask your health care||
1668|007|Z|professional for complete information about this product and your||
1668|008|Z|specific health needs.||
1668|009|B|||
1668|010|T|FLUTICASONE POWDER INHALER - ORAL INHALATION||
1668|011|F|(floo-TIK-a-sone)||
1668|012|B|||
1668|013|C|COMMON BRAND NAME(S): Arnuity Ellipta||
1668|014|B|||
1668|015|U|USES:  Fluticasone is used to control and prevent symptoms (such||
1668|016|U|as wheezing and shortness of breath) caused by asthma.||
1668|017|U|Controlling symptoms of asthma helps you maintain your normal||
1668|018|U|activities and decreases time lost from work or school.||
1668|019|U|Fluticasone belongs to a class of drugs known as corticosteroids.||
1668|020|U|It works by reducing swelling (inflammation) of the airways in||
1668|021|U|the lungs to make breathing easier.||
1668|022|U|   This medication must be used regularly to be effective. It||
1668|023|U|does not work right away and should not be used to relieve sudden||
1668|024|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
1668|025|U|inhaler (such as albuterol, also called salbutamol in some||
1668|026|U|countries) as prescribed.||
1668|027|B|||
1668|028|V|OTHER USES:  This section contains uses of this drug that are not||
1668|029|V|listed in the approved professional labeling for the drug but||
1668|030|V|that may be prescribed by your health care professional. Use this||
1668|031|V|drug for a condition that is listed in this section only if it||
1668|032|V|has been so prescribed by your health care professional.||
1668|033|V|   This drug may also be used to control symptoms (such as||
1668|034|V|wheezing and shortness of breath) caused by ongoing lung disease||
1668|035|V|(chronic obstructive pulmonary disease-COPD, which includes||
1668|036|V|chronic bronchitis and emphysema). It may also be used for a||
1668|037|V|certain esophagus problem (eosinophilic esophagitis).||
1668|038|B|||
1668|039|H|HOW TO USE:  Read the Patient Information Leaflet and the||
1668|040|H|Instructions for Use provided by your pharmacist before you start||
1668|041|H|using this medication and each time you get a refill. Follow the||
1668|042|H|illustrated directions for the proper use of this medication. If||
1668|043|H|you have any questions, ask your doctor or pharmacist.||
1668|044|H|   Inhale this medication by mouth as directed by your doctor,||
1668|045|H|usually once daily. The dosage is based on your medical condition||
1668|046|H|and response to treatment.||
1668|047|H|   Inhale each dose deeply to get the drug into your lungs. You||
1668|048|H|may or may not taste/feel the drug when you inhale. Either is||
1668|049|H|normal. Do not breathe out (exhale) into the inhaler device.||
1668|050|H|   If you are using other inhalers at the same time, wait at||
1668|051|H|least 1 minute between the use of each medication, and use this||
1668|052|H|drug (the corticosteroid) last.||
1668|053|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
1668|054|H|from developing, gargle, rinse your mouth with water and spit out||
1668|055|H|after each use. Do not swallow the rinse water.||
1668|056|H|   Use this medication regularly to get the most benefit from it.||
1668|057|H|This medication works best if used at evenly spaced intervals. To||
1668|058|H|help you remember, use it at the same time each day. Do not||
1668|059|H|increase your dose, use this drug more often, or stop using it||
1668|060|H|without first consulting your doctor.||
1668|061|H|   If you are regularly taking a different corticosteroid by||
1668|062|H|mouth (such as prednisone), you should not stop taking it unless||
1668|063|H|directed by your doctor. Some conditions (such as asthma,||
1668|064|H|allergies) may become worse when the drug is suddenly stopped. If||
1668|065|H|you suddenly stop taking the drug, you may also have withdrawal||
1668|066|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
1668|067|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
1668|068|H|doctor may slowly lower the dose of your old medication after you||
1668|069|H|begin using fluticasone. Tell your doctor or pharmacist right||
1668|070|H|away if you have withdrawal. See also Precautions section.||
1668|071|H|   It may take up to 2 weeks or longer before you get the full||
1668|072|H|benefit of this drug. Tell your doctor if your symptoms do not||
1668|073|H|get better or if they get worse.||
1668|074|H|   Learn which of your inhalers you should use every day||
1668|075|H|(controller drugs) and which you should use if your breathing||
1668|076|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
1668|077|H|time what you should do if you have new or worsening cough or||
1668|078|H|shortness of breath, wheezing, increased sputum, worsening peak||
1668|079|H|flow meter readings, waking up at night with trouble breathing,||
1668|080|H|if you use your quick-relief inhaler more often (more than 2 days||
1668|081|H|a week), or if your quick-relief inhaler does not seem to be||
1668|082|H|working well. Learn when you can treat sudden breathing problems||
1668|083|H|by yourself and when you must get medical help right away.||
1668|084|B|||
1668|085|S|SIDE EFFECTS:  See also Precautions section.||
1668|086|S|   Dry/irritated throat, hoarseness, or coughing may occur as||
1668|087|S|your body adjusts to the medication. If any of these effects last||
1668|088|S|or get worse, tell your doctor or pharmacist promptly.||
1668|089|S|   Remember that this medication has been prescribed because your||
1668|090|S|doctor has judged that the benefit to you is greater than the||
1668|091|S|risk of side effects. Many people using this medication do not||
1668|092|S|have serious side effects.||
1668|093|S|   Tell your doctor right away if you have any serious side||
1668|094|S|effects, including: white patches in your mouth or on your||
1668|095|S|tongue, signs of infection (such as sore throat that doesn't go||
1668|096|S|away, fever, chills), mental/mood changes (such as depression,||
1668|097|S|mood swings, agitation), vision problems, increased||
1668|098|S|thirst/urination, easy bruising/bleeding, bone pain.||
1668|099|S|   Rarely, this medication may cause sudden severe||
1668|100|S|wheezing/trouble breathing immediately after you use it. If this||
1668|101|S|occurs, use your quick-relief inhaler and get medical help right||
1668|102|S|away.||
1668|103|S|   A very serious allergic reaction to this drug is rare.||
1668|104|S|However, get medical help right away if you notice any symptoms||
1668|105|S|of a serious allergic reaction, including: rash, itching/swelling||
1668|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1668|107|S|breathing.||
1668|108|S|   This is not a complete list of possible side effects. If you||
1668|109|S|notice other effects not listed above, contact your doctor or||
1668|110|S|pharmacist.||
1668|111|S|   In the US -||
1668|112|S|   Call your doctor for medical advice about side effects. You||
1668|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1668|114|S|www.fda.gov/medwatch.||
1668|115|S|   In Canada - Call your doctor for medical advice about side||
1668|116|S|effects. You may report side effects to Health Canada at||
1668|117|S|1-866-234-2345.||
1668|118|B|||
1668|119|P|PRECAUTIONS:  Before using fluticasone, tell your doctor or||
1668|120|P|pharmacist if you are allergic to it; or if you have any other||
1668|121|P|allergies. This product may contain inactive ingredients (such as||
1668|122|P|milk proteins), which can cause allergic reactions or other||
1668|123|P|problems. Talk to your pharmacist for more details.||
1668|124|P|   Before using this medication, tell your doctor or pharmacist||
1668|125|P|your medical history, especially of: current/past infections||
1668|126|P|(such as tuberculosis, herpes), bone loss (osteoporosis), eye||
1668|127|P|problems (such as cataracts, glaucoma), liver disease.||
1668|128|P|   If you have switched from a corticosteroid taken by mouth||
1668|129|P|(such as prednisone tablets) to this inhaler within the past 12||
1668|130|P|months, or if you have been using this product in||
1668|131|P|higher-than-usual doses for a long time, it may be more difficult||
1668|132|P|for your body to respond to physical stress. Before having||
1668|133|P|surgery or emergency treatment, or if you get a serious||
1668|134|P|illness/injury, tell your doctor or dentist that you are using||
1668|135|P|this medication or have used a corticosteroid taken by mouth||
1668|136|P|within the past 12 months. Tell your doctor right away if you||
1668|137|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
1668|138|P|card or medical ID bracelet that says you use (or have used)||
1668|139|P|corticosteroid medications.||
1668|140|P|   Before having surgery, tell your doctor or dentist about all||
1668|141|P|the products you use (including prescription drugs,||
1668|142|P|nonprescription drugs, and herbal products).||
1668|143|P|   This medication may mask signs of infection. It can make you||
1668|144|P|more likely to get infections or may make current infections||
1668|145|P|worse. Stay away from anyone who has an infection that may easily||
1668|146|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1668|147|P|doctor if you have been exposed to an infection or for more||
1668|148|P|details.||
1668|149|P|   This medication may temporarily slow down a child's growth if||
1668|150|P|used for a long time. However, poorly controlled asthma can also||
1668|151|P|slow down growth. See the doctor regularly so your child's height||
1668|152|P|can be checked.||
1668|153|P|   During pregnancy, this medication should be used only when||
1668|154|P|clearly needed. Discuss the risks and benefits with your doctor.||
1668|155|P|   It is unknown if this drug passes into breast milk. Consult||
1668|156|P|your doctor before breastfeeding.||
1668|157|B|||
1668|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1668|159|I|medications work or increase your risk for serious side effects.||
1668|160|I|This document does not contain all possible drug interactions.||
1668|161|I|Keep a list of all the products you use (including||
1668|162|I|prescription/nonprescription drugs and herbal products) and share||
1668|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
1668|164|I|the dosage of any medicines without your doctor's approval.||
1668|165|I|   A product that may interact with this drug is: desmopressin.||
1668|166|I|   Other medications can affect the removal of fluticasone from||
1668|167|I|your body, which may affect how fluticasone works. Examples||
1668|168|I|include some azole antifungals (such as ketoconazole), HIV||
1668|169|I|protease inhibitors (such as lopinavir), ritonavir, among others.||
1668|170|B|||
1668|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1668|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1668|173|O|poison control center right away. US residents can call||
1668|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1668|175|B|||
1668|176|N|NOTES:  Do not share this medication with others.||
1668|177|N|   Lab and/or medical tests (such as cortisol levels, lung||
1668|178|N|function, eye exams, bone density tests) should be done while you||
1668|179|N|are using this medication. Keep all medical and lab appointments.||
1668|180|N|Consult your doctor for more details.||
1668|181|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
1668|182|N|mold that can worsen breathing problems. Because the flu virus||
1668|183|N|can also worsen breathing problems, ask your doctor or pharmacist||
1668|184|N|if you should have a flu shot every year.||
1668|185|N|   This medication may cause bone loss (osteoporosis) in adults||
1668|186|N|when used for a long time. Lifestyle changes that may help reduce||
1668|187|N|the risk of bone problems include doing weight-bearing exercise,||
1668|188|N|stopping smoking, limiting alcohol, and getting enough calcium||
1668|189|N|and vitamin D. Talk to your doctor for more details.||
1668|190|B|||
1668|191|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1668|192|D|If it is near the time of the next dose, skip the missed dose.||
1668|193|D|Use your next dose at the regular time. Do not double the dose to||
1668|194|D|catch up.||
1668|195|B|||
1668|196|R|STORAGE:  Different brands of this medication have different||
1668|197|R|storage needs. Check the product package for instructions on how||
1668|198|R|to store your brand, or ask your pharmacist. Do not open the||
1668|199|R|original foil package until you are ready to use the medication.||
1668|200|R|Once the foil package is opened, this medication expires after 6||
1668|201|R|weeks. Keep all medications away from children and pets.||
1668|202|R|   Do not flush medications down the toilet or pour them into a||
1668|203|R|drain unless instructed to do so. Properly discard this product||
1668|204|R|when it is expired or no longer needed. Consult your pharmacist||
1668|205|R|or local waste disposal company.||
1668|206|B|||
1668|207|M|MEDICAL ALERT:  Your condition can cause complications in a||
1668|208|M|medical emergency. For information about enrolling in MedicAlert,||
1668|209|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1668|210|B|||
1668|211|A|Information last revised September 2025.||
1668|212|A|Copyright(c) 2025 First Databank, Inc.||
1668|213|B|||
1669|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1669|002|Z|does NOT have all possible information about this product. This||
1669|003|Z|information does not assure that this product is safe, effective,||
1669|004|Z|or appropriate for you. This information is not individual||
1669|005|Z|medical advice and does not substitute for the advice of your||
1669|006|Z|health care professional. Always ask your health care||
1669|007|Z|professional for complete information about this product and your||
1669|008|Z|specific health needs.||
1669|009|B|||
1669|010|T|CEFTOLOZANE/TAZOBACTAM - INJECTION||
1669|011|F|(sef-TOL-oh-zane/TAZ-oh-BAK-tam)||
1669|012|B|||
1669|013|C|COMMON BRAND NAME(S): Zerbaxa||
1669|014|B|||
1669|015|U|USES:  Ceftolozane/tazobactam is used to treat a variety of||
1669|016|U|bacterial infections. It is a cephalosporin antibiotic. It works||
1669|017|U|by stopping the growth of bacteria.||
1669|018|B|||
1669|019|H|HOW TO USE:  This medication is given by injection into a vein as||
1669|020|H|directed by your doctor, usually every 8 hours. It should be||
1669|021|H|injected slowly over 1 hour. The dosage is based on your medical||
1669|022|H|condition and response to treatment. Children's dosage is also||
1669|023|H|based on weight.||
1669|024|H|   If you are using this medication at home, learn all||
1669|025|H|preparation and usage instructions from your health care||
1669|026|H|professional. Before using, check this product for particles or||
1669|027|H|discoloration. If either is present, do not use the liquid..||
1669|028|H|Learn how to store and discard medical supplies safely.||
1669|029|H|   For the best effect, use this antibiotic at evenly spaced||
1669|030|H|times. To help you remember, use this medication at the same||
1669|031|H|time(s) every day.||
1669|032|H|   Continue to use this medication until the full prescribed||
1669|033|H|treatment period is finished, even if symptoms disappear after a||
1669|034|H|few days. Stopping the medication too early may result in a||
1669|035|H|return of the infection.||
1669|036|H|   Tell your doctor if your condition lasts or gets worse.||
1669|037|B|||
1669|038|S|SIDE EFFECTS:  Pain, redness, or irritation at the injection site||
1669|039|S|may occur. Nausea, diarrhea, or headache may also occur. If any||
1669|040|S|of these effects last or get worse, tell your doctor or||
1669|041|S|pharmacist promptly.||
1669|042|S|   Remember that this medication has been prescribed because your||
1669|043|S|doctor has judged that the benefit to you is greater than the||
1669|044|S|risk of side effects. Many people using this medication do not||
1669|045|S|have serious side effects.||
1669|046|S|   Tell your doctor right away if you have any serious side||
1669|047|S|effects, including: muscle cramps, weakness, fast/slow/irregular||
1669|048|S|heartbeat, signs of kidney problems (such as change in the amount||
1669|049|S|of urine).||
1669|050|S|   Get medical help right away if you have any very serious side||
1669|051|S|effects, including: confusion, trouble speaking.||
1669|052|S|   This medication may rarely cause a severe intestinal condition||
1669|053|S|due to a bacteria called C. difficile. This condition may occur||
1669|054|S|during treatment or weeks to months after treatment has stopped.||
1669|055|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1669|056|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1669|057|S|stool.||
1669|058|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1669|059|S|products because they may make symptoms worse.||
1669|060|S|   Use of this medication for prolonged or repeated periods may||
1669|061|S|result in oral thrush or a new yeast infection. Contact your||
1669|062|S|doctor if you notice white patches in your mouth, a change in||
1669|063|S|vaginal discharge, or other new symptoms.||
1669|064|S|   A very serious allergic reaction to this drug is rare.||
1669|065|S|However, get medical help right away if you notice any symptoms||
1669|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1669|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1669|068|S|breathing.||
1669|069|S|   This is not a complete list of possible side effects. If you||
1669|070|S|notice other effects not listed above, contact your doctor or||
1669|071|S|pharmacist.||
1669|072|S|   In the US -||
1669|073|S|   Call your doctor for medical advice about side effects. You||
1669|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1669|075|S|www.fda.gov/medwatch.||
1669|076|S|   In Canada - Call your doctor for medical advice about side||
1669|077|S|effects. You may report side effects to Health Canada at||
1669|078|S|1-866-234-2345.||
1669|079|B|||
1669|080|P|PRECAUTIONS:  Before using ceftolozane/tazobactam, tell your||
1669|081|P|doctor or pharmacist if you are allergic to it; or to||
1669|082|P|cephalosporins, penicillins, or other antibiotics; or if you have||
1669|083|P|any other allergies. This product may contain inactive||
1669|084|P|ingredients, which can cause allergic reactions or other||
1669|085|P|problems. Talk to your pharmacist for more details.||
1669|086|P|   Before using this medication, tell your doctor or pharmacist||
1669|087|P|your medical history, especially of: kidney disease.||
1669|088|P|   This medication contains sodium. Consult your doctor or||
1669|089|P|pharmacist if you are on a salt-restricted diet or if you have a||
1669|090|P|condition that could be worsened by an increase in salt intake||
1669|091|P|(such as heart failure, high blood pressure).||
1669|092|P|   Ceftolozane/tazobactam may cause live bacterial vaccines (such||
1669|093|P|as typhoid vaccine) to not work well. Tell your health care||
1669|094|P|professional that you are using ceftolozane/tazobactam before||
1669|095|P|having any immunizations/vaccinations.||
1669|096|P|   Before having surgery, tell your doctor or dentist about all||
1669|097|P|the products you use (including prescription drugs,||
1669|098|P|nonprescription drugs, and herbal products).||
1669|099|P|   During pregnancy, this medication should be used only when||
1669|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
1669|101|P|   It is unknown if this medication passes into breast milk.||
1669|102|P|Consult your doctor before breastfeeding||
1669|103|B|||
1669|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1669|105|I|medications work or increase your risk for serious side effects.||
1669|106|I|This document does not contain all possible drug interactions.||
1669|107|I|Keep a list of all the products you use (including||
1669|108|I|prescription/nonprescription drugs and herbal products) and share||
1669|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
1669|110|I|the dosage of any medicines without your doctor's approval.||
1669|111|I|   This medication may interfere with certain lab tests (such as||
1669|112|I|certain urine glucose tests), possibly causing false test||
1669|113|I|results. Make sure lab personnel and all your doctors know you||
1669|114|I|use this drug.||
1669|115|B|||
1669|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1669|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1669|118|O|poison control center right away. US residents can call||
1669|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1669|120|B|||
1669|121|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1669|122|N|kidney function) may be done while you are using this medication.||
1669|123|N|Keep all medical and lab appointments. Consult your doctor for||
1669|124|N|more details.||
1669|125|B|||
1669|126|D|MISSED DOSE:  It is important to get each dose of this medication||
1669|127|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1669|128|D|right away for a new dosing schedule. Do not double the dose to||
1669|129|D|catch up.||
1669|130|B|||
1669|131|R|STORAGE:  Consult the product instructions and your pharmacist||
1669|132|R|for storage details. Keep all medications away from children and||
1669|133|R|pets.||
1669|134|R|   Do not flush medications down the toilet or pour them into a||
1669|135|R|drain unless instructed to do so. Properly discard this product||
1669|136|R|when it is expired or no longer needed. Consult your pharmacist||
1669|137|R|or local waste disposal company.||
1669|138|B|||
1669|139|A|Information last revised November 2024.||
1669|140|A|Copyright(c) 2025 First Databank, Inc.||
1669|141|B|||
1670|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1670|002|Z|does NOT have all possible information about this product. This||
1670|003|Z|information does not assure that this product is safe, effective,||
1670|004|Z|or appropriate for you. This information is not individual||
1670|005|Z|medical advice and does not substitute for the advice of your||
1670|006|Z|health care professional. Always ask your health care||
1670|007|Z|professional for complete information about this product and your||
1670|008|Z|specific health needs.||
1670|009|B|||
1670|010|T|METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA - INJECTION||
1670|011|B|||
1670|012|C|COMMON BRAND NAME(S): Mircera||
1670|013|B|||
1670|014|W|WARNING:  Discuss the risks and benefits of methoxy polyethylene||
1670|015|W|glycol-epoetin beta with your doctor, as this medication may||
1670|016|W|rarely cause very serious (possibly fatal) side effects,||
1670|017|W|including blood clots, heart attack, stroke, or heart failure. It||
1670|018|W|is very important to keep all lab appointments since your doctor||
1670|019|W|will need to carefully check your red blood cell count and||
1670|020|W|hemoglobin level. The lowest effective dose of this medication||
1670|021|W|should be used.||
1670|022|W|   When used to treat anemia related to cancer, this medication||
1670|023|W|may also increase the risk of death and/or cause the tumor to||
1670|024|W|grow faster. This medication is not approved for the treatment of||
1670|025|W|anemia related to cancer. Ask your doctor about the risks and||
1670|026|W|benefits of this medication, as well as other effective and||
1670|027|W|possibly safer treatments for anemia related to cancer.||
1670|028|B|||
1670|029|U|USES:  This medication is used to treat anemia (low red blood||
1670|030|U|cell count) in people with long-term serious kidney disease||
1670|031|U|(chronic kidney disease). It works by signaling the bone marrow||
1670|032|U|to make more red blood cells. Methoxy polyethylene glycol-epoetin||
1670|033|U|beta helps to reverse anemia. It also helps to reduce the need||
1670|034|U|for blood transfusions. This medication is very similar to the||
1670|035|U|natural substance in your body (erythropoietin) that prevents||
1670|036|U|anemia.||
1670|037|B|||
1670|038|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1670|039|H|Instructions for Use provided by your pharmacist before you start||
1670|040|H|using methoxy polyethylene glycol-epoetin beta and each time you||
1670|041|H|get a refill. If you have any questions, ask your doctor or||
1670|042|H|pharmacist.||
1670|043|H|   This medication is injected into a vein or under the skin as||
1670|044|H|directed by your doctor, usually once every 2 or 4 weeks.||
1670|045|H|Hemodialysis patients should receive this medication by injection||
1670|046|H|into a vein. The dosage is based on your medical condition,||
1670|047|H|weight, lab tests, and response to treatment.||
1670|048|H|   If you are using this medication at home, learn all||
1670|049|H|preparation and usage instructions from your health care||
1670|050|H|professional. Take the medication out of the refrigerator to||
1670|051|H|allow it to reach room temperature. Do not shake the medication.||
1670|052|H|Before using, check this product for particles or discoloration.||
1670|053|H|If either is present, do not use the liquid. If you are injecting||
1670|054|H|this medication under the skin, before each dose, clean the skin||
1670|055|H|you are going to inject into (the injection site) with rubbing||
1670|056|H|alcohol. Change the injection site each time to lessen injury||
1670|057|H|under the skin. To lessen bruising, do not rub the injection site||
1670|058|H|after a shot. Learn how to store and discard medical supplies||
1670|059|H|safely.||
1670|060|H|   Use this medication regularly to get the most benefit from it.||
1670|061|H|To help you remember, mark your calendar with a reminder.||
1670|062|H|   Do not increase your dose or use this drug more often or for||
1670|063|H|longer than prescribed. Your condition will not improve any||
1670|064|H|faster, and your risk of side effects will increase.||
1670|065|H|   It may take 2 to 6 weeks before your red blood cell count||
1670|066|H|increases. Tell your doctor if your symptoms do not get better or||
1670|067|H|if they get worse.||
1670|068|B|||
1670|069|S|SIDE EFFECTS:  Headache, body aches, diarrhea, or vomiting may||
1670|070|S|occur. If any of these effects last or get worse, tell your||
1670|071|S|doctor or pharmacist promptly.||
1670|072|S|   Remember that this medication has been prescribed because your||
1670|073|S|doctor has judged that the benefit to you is greater than the||
1670|074|S|risk of side effects. Many people using this medication do not||
1670|075|S|have serious side effects.||
1670|076|S|   Methoxy polyethylene glycol-epoetin beta may sometimes cause||
1670|077|S|or worsen high blood pressure, especially in patients with||
1670|078|S|long-term kidney failure. This effect may be caused by the number||
1670|079|S|of red blood cells increasing too quickly, usually within the||
1670|080|S|first 3 months of starting treatment. If you have high blood||
1670|081|S|pressure, it should be well controlled before beginning treatment||
1670|082|S|with this medication. Your blood pressure should be checked||
1670|083|S|often. Ask your doctor if you should learn how to check your own||
1670|084|S|blood pressure. If high blood pressure develops or worsens,||
1670|085|S|follow your doctor's instructions about diet changes and starting||
1670|086|S|or adjusting your high blood pressure medication. Lowering high||
1670|087|S|blood pressure helps prevent strokes, heart attacks, and further||
1670|088|S|kidney problems. Keep all lab appointments to have your red blood||
1670|089|S|cell count/hemoglobin level tested regularly to reduce the chance||
1670|090|S|of this side effect.||
1670|091|S|   Rarely, this medication may suddenly stop working well after a||
1670|092|S|period of time because your body may make antibodies to it. A||
1670|093|S|very serious anemia can result. Tell your doctor right away if||
1670|094|S|symptoms of anemia return (such as increased tiredness, low||
1670|095|S|energy, pale skin color, shortness of breath).||
1670|096|S|   Tell your doctor right away if you have any serious side||
1670|097|S|effects, including: symptoms of heart failure (such as shortness||
1670|098|S|of breath, swelling ankles/feet, unusual tiredness,||
1670|099|S|unusual/sudden weight gain).||
1670|100|S|   Get medical help right away if you have any very serious side||
1670|101|S|effects, including: seizures.||
1670|102|S|   This medication may rarely cause serious (sometimes fatal)||
1670|103|S|problems from blood clots (such as heart attack, stroke, blood||
1670|104|S|clots in the legs or lungs). Get medical help right away if you||
1670|105|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1670|106|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
1670|107|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1670|108|S|trouble speaking, weakness on one side of the body, sudden vision||
1670|109|S|changes, blood clots in your hemodialysis vascular access site.||
1670|110|S|   A very serious allergic reaction to this drug is rare.||
1670|111|S|However, get medical help right away if you notice any symptoms||
1670|112|S|of a serious allergic reaction, including: rash, itching/swelling||
1670|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1670|114|S|breathing, fast heartbeat.||
1670|115|S|   This is not a complete list of possible side effects. If you||
1670|116|S|notice other effects not listed above, contact your doctor or||
1670|117|S|pharmacist.||
1670|118|S|   In the US -||
1670|119|S|   Call your doctor for medical advice about side effects. You||
1670|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1670|121|S|www.fda.gov/medwatch.||
1670|122|S|   In Canada - Call your doctor for medical advice about side||
1670|123|S|effects. You may report side effects to Health Canada at||
1670|124|S|1-866-234-2345.||
1670|125|B|||
1670|126|P|PRECAUTIONS:  Before using methoxy polyethylene glycol-epoetin||
1670|127|P|beta, tell your doctor or pharmacist if you are allergic to it;||
1670|128|P|or to other drugs that cause more red blood cells to be made||
1670|129|P|(such as epoetin alfa, darbepoetin alfa); or if you have any||
1670|130|P|other allergies. This product may contain inactive ingredients,||
1670|131|P|which can cause allergic reactions or other problems. Talk to||
1670|132|P|your pharmacist for more details.||
1670|133|P|   Before using this medication, tell your doctor or pharmacist||
1670|134|P|your medical history, especially of: high blood pressure, heart||
1670|135|P|disease (such as heart failure, past heart attack/stroke),||
1670|136|P|seizure disorder, severe anemia caused by antibodies to past||
1670|137|P|erythropoietin-type treatment (pure red cell aplasia).||
1670|138|P|   Before having surgery, tell your doctor or dentist about all||
1670|139|P|the products you use (including prescription drugs,||
1670|140|P|nonprescription drugs, and herbal products).||
1670|141|P|   During pregnancy, this medication should be used only when||
1670|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
1670|143|P|   It is unknown if this medication passes into breast milk.||
1670|144|P|Consult your doctor before breastfeeding.||
1670|145|B|||
1670|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1670|147|I|medications work or increase your risk for serious side effects.||
1670|148|I|This document does not contain all possible drug interactions.||
1670|149|I|Keep a list of all the products you use (including||
1670|150|I|prescription/nonprescription drugs and herbal products) and share||
1670|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
1670|152|I|the dosage of any medicines without your doctor's approval.||
1670|153|B|||
1670|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1670|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1670|156|O|poison control center right away. US residents can call||
1670|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1670|158|B|||
1670|159|N|NOTES:  Do not share this medication with others.||
1670|160|N|   Lab and/or medical tests (such as blood pressure, complete||
1670|161|N|blood count that includes hemoglobin level) should be done while||
1670|162|N|you are using this medication. Keep all medical and lab||
1670|163|N|appointments. Consult your doctor for more details.||
1670|164|N|   Blood tests for your iron levels will also be done and you may||
1670|165|N|be prescribed iron supplements to take. Your doctor may recommend||
1670|166|N|that you eat a well-balanced diet rich in iron (such as raisins,||
1670|167|N|figs, meat, eggs, vegetables, iron-fortified cereals). Follow||
1670|168|N|your doctor's instructions and dietary recommendations.||
1670|169|B|||
1670|170|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
1670|171|D|right away for a new dosing schedule. Do not double the dose to||
1670|172|D|catch up.||
1670|173|B|||
1670|174|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1670|175|R|medication in the original carton to protect from light. This||
1670|176|R|medication may also be stored at room temperature if needed. If||
1670|177|R|the medication is stored at room temperature, discard after 30||
1670|178|R|days. After each dose, discard any unused medication right away.||
1670|179|R|Keep all medications away from children and pets.||
1670|180|R|   Do not flush medications down the toilet or pour them into a||
1670|181|R|drain unless instructed to do so. Properly discard this product||
1670|182|R|when it is expired or no longer needed. Consult your pharmacist||
1670|183|R|or local waste disposal company.||
1670|184|B|||
1670|185|A|Information last revised October 2024.||
1670|186|A|Copyright(c) 2025 First Databank, Inc.||
1670|187|B|||
1671|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1671|002|Z|does NOT have all possible information about this product. This||
1671|003|Z|information does not assure that this product is safe, effective,||
1671|004|Z|or appropriate for you. This information is not individual||
1671|005|Z|medical advice and does not substitute for the advice of your||
1671|006|Z|health care professional. Always ask your health care||
1671|007|Z|professional for complete information about this product and your||
1671|008|Z|specific health needs.||
1671|009|B|||
1671|010|T|IVERMECTIN CREAM - TOPICAL||
1671|011|F|(EYE-ver-MEK-tin)||
1671|012|B|||
1671|013|C|COMMON BRAND NAME(S): Soolantra||
1671|014|B|||
1671|015|U|USES:  This medication is used to treat a certain skin condition||
1671|016|U|called rosacea, a type of adult acne. Ivermectin may help to||
1671|017|U|decrease symptoms caused by rosacea, such as redness, swelling,||
1671|018|U|and pimples.||
1671|019|B|||
1671|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
1671|021|H|Instructions for Use if available from your pharmacist before you||
1671|022|H|start using ivermectin cream and each time you get a refill. If||
1671|023|H|you have any questions, ask your doctor or pharmacist.||
1671|024|H|   This medication is for use only on the face. Clean the||
1671|025|H|affected area with a mild soap or soap-free cleanser and pat dry.||
1671|026|H|Apply this medication to the affected areas of the face as||
1671|027|H|directed by your doctor, usually once a day. Use a pea-sized||
1671|028|H|amount for each area of the face (such as the forehead, chin,||
1671|029|H|nose, each cheek) that is affected. Spread the cream smoothly and||
1671|030|H|evenly in a thin layer. Wash your hands well after applying.||
1671|031|H|   Avoid getting this medication in your eyes, inside your nose,||
1671|032|H|or on your lips. If this accidentally happens, rinse right away||
1671|033|H|with plenty of cool water.||
1671|034|H|   Use this medication regularly to get the most benefit from it.||
1671|035|H|To help you remember, use it at the same time each day.||
1671|036|H|   Do not use large amounts or apply this product more often than||
1671|037|H|directed. Your condition will not clear faster, and the chance of||
1671|038|H|side effects may be increased. It may take several weeks of||
1671|039|H|continued use before you see the effects of this medication. Tell||
1671|040|H|your doctor if your condition does not get better or if it gets||
1671|041|H|worse.||
1671|042|B|||
1671|043|S|SIDE EFFECTS:  Skin irritation (such as redness or a burning||
1671|044|S|feeling) may rarely occur. If this effect lasts or gets worse,||
1671|045|S|tell your doctor or pharmacist promptly.||
1671|046|S|   Remember that this medication has been prescribed because your||
1671|047|S|doctor has judged that the benefit to you is greater than the||
1671|048|S|risk of side effects. Many people using this medication do not||
1671|049|S|have serious side effects.||
1671|050|S|   A very serious allergic reaction to this drug is rare.||
1671|051|S|However, get medical help right away if you notice any symptoms||
1671|052|S|of a serious allergic reaction, including: rash, itching/swelling||
1671|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1671|054|S|breathing.||
1671|055|S|   This is not a complete list of possible side effects. If you||
1671|056|S|notice other effects not listed above, contact your doctor or||
1671|057|S|pharmacist.||
1671|058|S|   In the US -||
1671|059|S|   Call your doctor for medical advice about side effects. You||
1671|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1671|061|S|www.fda.gov/medwatch.||
1671|062|S|   In Canada - Call your doctor for medical advice about side||
1671|063|S|effects. You may report side effects to Health Canada at||
1671|064|S|1-866-234-2345.||
1671|065|B|||
1671|066|P|PRECAUTIONS:  Before using ivermectin cream, tell your doctor or||
1671|067|P|pharmacist if you are allergic to it; or if you have any other||
1671|068|P|allergies. This product may contain inactive ingredients, which||
1671|069|P|can cause allergic reactions or other problems. Talk to your||
1671|070|P|pharmacist for more details.||
1671|071|P|   Before using this medication, tell your doctor or pharmacist||
1671|072|P|your medical history.||
1671|073|P|   Before having surgery, tell your doctor or dentist about all||
1671|074|P|the products you use (including prescription drugs,||
1671|075|P|nonprescription drugs, and herbal products).||
1671|076|P|   During pregnancy, this medication should be used only when||
1671|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
1671|078|P|   The form of this medication taken by mouth passes into breast||
1671|079|P|milk in small amounts. It is unknown if this form of ivermectin||
1671|080|P|passes into breast milk. Consult your doctor before||
1671|081|P|breastfeeding.||
1671|082|B|||
1671|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1671|084|I|medications work or increase your risk for serious side effects.||
1671|085|I|This document does not contain all possible drug interactions.||
1671|086|I|Keep a list of all the products you use (including||
1671|087|I|prescription/nonprescription drugs and herbal products) and share||
1671|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
1671|089|I|the dosage of any medicines without your doctor's approval.||
1671|090|B|||
1671|091|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1671|092|O|has overdosed and has serious symptoms such as passing out or||
1671|093|O|trouble breathing, call 911. Otherwise, call a poison control||
1671|094|O|center right away. US residents can call 1-800-222-1222. Canada||
1671|095|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1671|096|O|include: rash, swelling, headache, dizziness, vomiting, diarrhea,||
1671|097|O|numbness/tingling, seizures.||
1671|098|B|||
1671|099|N|NOTES:  Do not share this medication with others.||
1671|100|N|   Spending time in the sun can worsen rosacea. Wear a||
1671|101|N|wide-brimmed hat and use sunscreen to avoid getting too much sun.||
1671|102|N|Other triggers that may worsen rosacea include wind, hot||
1671|103|N|beverages, spicy foods, alcohol, and either hot or cold weather.||
1671|104|B|||
1671|105|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1671|106|D|If it is near the time of the next dose, skip the missed dose.||
1671|107|D|Use your next dose at the regular time. Do not double the dose to||
1671|108|D|catch up.||
1671|109|B|||
1671|110|R|STORAGE:  Store at room temperature. Keep all medications away||
1671|111|R|from children and pets.||
1671|112|R|   Do not flush medications down the toilet or pour them into a||
1671|113|R|drain unless instructed to do so. Properly discard this product||
1671|114|R|when it is expired or no longer needed. Consult your pharmacist||
1671|115|R|or local waste disposal company.||
1671|116|B|||
1671|117|A|Information last revised November 2024.||
1671|118|A|Copyright(c) 2025 First Databank, Inc.||
1671|119|B|||
1673|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1673|002|Z|does NOT have all possible information about this product. This||
1673|003|Z|information does not assure that this product is safe, effective,||
1673|004|Z|or appropriate for you. This information is not individual||
1673|005|Z|medical advice and does not substitute for the advice of your||
1673|006|Z|health care professional. Always ask your health care||
1673|007|Z|professional for complete information about this product and your||
1673|008|Z|specific health needs.||
1673|009|B|||
1673|010|T|NIVOLUMAB - INJECTION||
1673|011|F|(nye-VOL-ue-mab)||
1673|012|B|||
1673|013|C|COMMON BRAND NAME(S): Opdivo||
1673|014|B|||
1673|015|U|USES:  Nivolumab is used to treat cancer. It works by helping||
1673|016|U|your immune system fight the cancer. Nivolumab belongs to a class||
1673|017|U|of drugs known as monoclonal antibodies.||
1673|018|B|||
1673|019|H|HOW TO USE:  Read the Medication Guide provided by your||
1673|020|H|pharmacist before you start receiving nivolumab and each time you||
1673|021|H|get a treatment. If you have any questions, ask your doctor or||
1673|022|H|pharmacist.||
1673|023|H|   This medication is given by a health care professional. It is||
1673|024|H|injected slowly into a vein over 30 minutes. It is given as||
1673|025|H|directed by your doctor, usually once every 2 to 4 weeks.||
1673|026|H|   Infusion reactions may happen during the infusion of this||
1673|027|H|drug. Tell your doctor right away if you have symptoms of||
1673|028|H|infusion reactions such as fever, chills, flushing, dizziness, or||
1673|029|H|fainting.||
1673|030|H|   The dosage is based on your medical condition, weight, and||
1673|031|H|response to treatment. Your doctor may stop your treatment for||
1673|032|H|some time if you get serious side effects. Your doctor may also||
1673|033|H|prescribe another medication (a corticosteroid such as||
1673|034|H|prednisone) to help treat side effects of this medication.||
1673|035|B|||
1673|036|S|SIDE EFFECTS:  See also How to Use section.||
1673|037|S|   Nausea, diarrhea, constipation, loss of appetite, headache,||
1673|038|S|bone/muscle pain, or tiredness may occur. If any of these effects||
1673|039|S|last or get worse, tell your doctor or pharmacist promptly.||
1673|040|S|   People using this medication may have serious side effects.||
1673|041|S|However, you have been prescribed this drug because your doctor||
1673|042|S|has judged that the benefit to you is greater than the risk of||
1673|043|S|side effects. Careful monitoring by your doctor may decrease your||
1673|044|S|risk.||
1673|045|S|   Tell your doctor right away if you have any serious side||
1673|046|S|effects, including: new/worsening cough, diarrhea with||
1673|047|S|blood/mucus, mouth/throat sores, symptoms of liver disease (such||
1673|048|S|as nausea/vomiting that doesn't stop, stomach/abdominal pain,||
1673|049|S|yellowing eyes/skin, dark urine), signs of kidney problems (such||
1673|050|S|as change in the amount of urine, pink/bloody urine), easy||
1673|051|S|bruising/bleeding, swelling hands/ankles/feet, unusual weakness,||
1673|052|S|joint stiffness/pain, muscle||
1673|053|S|weakness/tenderness/pain/spasms/cramps, numbness/tingling of||
1673|054|S|arms/legs, loss of coordination, eye redness/pain, sensitivity to||
1673|055|S|light, vision changes.||
1673|056|S|   Nivolumab may cause hormone gland problems (such as thyroid,||
1673|057|S|pituitary, adrenal, pancreas). Your body could make too much or||
1673|058|S|too little hormone. Tell your doctor right away if you have any||
1673|059|S|symptoms such as: cold or heat intolerance, unexplained weight||
1673|060|S|loss/gain, increased thirst/urination, mood or behavior changes||
1673|061|S|(such as decreased sex drive, irritability, forgetfulness),||
1673|062|S|slow/fast/pounding/irregular heartbeat.||
1673|063|S|   Get medical help right away if you have any very serious side||
1673|064|S|effects, including: chest pain, shortness of breath.||
1673|065|S|   Nivolumab can commonly cause itching or a rash that is usually||
1673|066|S|not serious. However, you may not be able to tell it apart from a||
1673|067|S|rare rash that could be a sign of a severe reaction. Get medical||
1673|068|S|help right away if you develop any rash or itching.||
1673|069|S|   A very serious allergic reaction to this drug is rare.||
1673|070|S|However, get medical help right away if you notice any symptoms||
1673|071|S|of a serious allergic reaction, including: fever, swollen lymph||
1673|072|S|nodes, rash, itching/swelling (especially of the||
1673|073|S|face/tongue/throat), severe dizziness, trouble breathing.||
1673|074|S|   This is not a complete list of possible side effects. If you||
1673|075|S|notice other effects not listed above, contact your doctor or||
1673|076|S|pharmacist.||
1673|077|S|   In the US -||
1673|078|S|   Call your doctor for medical advice about side effects. You||
1673|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1673|080|S|www.fda.gov/medwatch.||
1673|081|S|   In Canada - Call your doctor for medical advice about side||
1673|082|S|effects. You may report side effects to Health Canada at||
1673|083|S|1-866-234-2345.||
1673|084|B|||
1673|085|P|PRECAUTIONS:  Before using nivolumab, tell your doctor or||
1673|086|P|pharmacist if you are allergic to it; or if you have any other||
1673|087|P|allergies. This product may contain inactive ingredients, which||
1673|088|P|can cause allergic reactions or other problems. Talk to your||
1673|089|P|pharmacist for more details.||
1673|090|P|   Before using this medication, tell your doctor or pharmacist||
1673|091|P|your medical history, especially of: immune system problems (such||
1673|092|P|as Crohn's disease, ulcerative colitis, lupus), organ transplant,||
1673|093|P|stem cell transplant with donor cells, radiation treatment,||
1673|094|P|nervous system disorders (such as myasthenia gravis,||
1673|095|P|Guillain-Barre syndrome).||
1673|096|P|   Before having surgery, tell your doctor or dentist about all||
1673|097|P|the products you use (including prescription drugs,||
1673|098|P|nonprescription drugs, and herbal products).||
1673|099|P|   Tell your doctor if you are pregnant or plan to become||
1673|100|P|pregnant. You should not become pregnant while using nivolumab.||
1673|101|P|Nivolumab may harm an unborn baby. Your doctor should order a||
1673|102|P|pregnancy test before you start this medication. Ask about||
1673|103|P|reliable forms of birth control while using this medication and||
1673|104|P|for 5 months after the last dose. If you become pregnant, talk to||
1673|105|P|your doctor right away about the risks and benefits of this||
1673|106|P|medication.||
1673|107|P|   It is unknown if this drug passes into breast milk. Because of||
1673|108|P|the possible risk to the infant, breastfeeding is not recommended||
1673|109|P|while using this drug and for 5 months after the last dose.||
1673|110|P|Consult your doctor before breastfeeding.||
1673|111|B|||
1673|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1673|113|I|medications work or increase your risk for serious side effects.||
1673|114|I|This document does not contain all possible drug interactions.||
1673|115|I|Keep a list of all the products you use (including||
1673|116|I|prescription/nonprescription drugs and herbal products) and share||
1673|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
1673|118|I|the dosage of any medicines without your doctor's approval.||
1673|119|B|||
1673|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1673|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1673|122|O|poison control center right away. US residents can call||
1673|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1673|124|B|||
1673|125|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
1673|126|N|function, blood sugar) should be done before and during treatment||
1673|127|N|with this medication. Keep all medical and lab appointments.||
1673|128|N|Consult your doctor for more details.||
1673|129|B|||
1673|130|D|MISSED DOSE:  It is important to get each dose of this medication||
1673|131|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1673|132|D|right away for a new dosing schedule.||
1673|133|B|||
1673|134|R|STORAGE:  Not applicable. This medication is given in a hospital||
1673|135|R|or clinic and will not be stored at home.||
1673|136|B|||
1673|137|A|Information last revised April 2025.||
1673|138|A|Copyright(c) 2025 First Databank, Inc.||
1673|139|B|||
1674|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1674|002|Z|does NOT have all possible information about this product. This||
1674|003|Z|information does not assure that this product is safe, effective,||
1674|004|Z|or appropriate for you. This information is not individual||
1674|005|Z|medical advice and does not substitute for the advice of your||
1674|006|Z|health care professional. Always ask your health care||
1674|007|Z|professional for complete information about this product and your||
1674|008|Z|specific health needs.||
1674|009|B|||
1674|010|T|EDOXABAN - ORAL||
1674|011|F|(e-DOX-a-ban)||
1674|012|B|||
1674|013|C|COMMON BRAND NAME(S): Savaysa||
1674|014|B|||
1674|015|W|WARNING:  Your doctor should order a blood test to check your||
1674|016|W|kidney function before you start edoxaban. Edoxaban is affected||
1674|017|W|by the kidneys and may not work well to prevent blood clots from||
1674|018|W|atrial fibrillation in certain people due to their kidney||
1674|019|W|function. Talk to your doctor for more details and to see if this||
1674|020|W|medication is right for you.||
1674|021|W|   Do not stop taking edoxaban unless directed by your doctor. If||
1674|022|W|you stop taking this medication early, you have a higher risk of||
1674|023|W|forming a serious blood clot (such as a stroke, blood clot in the||
1674|024|W|legs/lungs). Your doctor may direct you to take a different||
1674|025|W|"blood thinning" or antiplatelet medication to reduce your risk.||
1674|026|W|Get medical help right away if you have weakness on one side of||
1674|027|W|the body, trouble speaking, sudden vision changes, confusion,||
1674|028|W|chest pain, trouble breathing, or pain/warmth/swelling in the||
1674|029|W|legs.||
1674|030|W|   People taking this medication may bleed near the spinal cord||
1674|031|W|after certain spinal procedures. Bleeding in this area can cause||
1674|032|W|paralysis that lasts a long time or could become permanent.||
1674|033|W|Before any spinal procedure, ask your doctor about the benefits||
1674|034|W|and risks. The risk of bleeding may be higher if you have a||
1674|035|W|deformed spine, or have had spinal procedures/surgery before||
1674|036|W|(such as epidural catheter placement, difficult epidural/spinal||
1674|037|W|puncture), or are taking other drugs that can cause||
1674|038|W|bleeding/bruising (including antiplatelet drugs such as||
1674|039|W|clopidogrel, "blood thinners" such as warfarin/enoxaparin,||
1674|040|W|nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen).||
1674|041|W|Tell your doctor right away if you notice symptoms such as back||
1674|042|W|pain, leg numbness/tingling/weakness, loss of control of the||
1674|043|W|bowels or bladder (incontinence).||
1674|044|B|||
1674|045|U|USES:  Edoxaban is used to prevent serious blood clots from||
1674|046|U|forming due to a certain irregular heartbeat (atrial||
1674|047|U|fibrillation). It is also used to treat certain blood clots (such||
1674|048|U|as in deep vein thrombosis-DVT or pulmonary embolus-PE).||
1674|049|U|   Edoxaban is an anticoagulant that works by blocking certain||
1674|050|U|clotting proteins in your blood.||
1674|051|B|||
1674|052|H|HOW TO USE:  See also Warning section.||
1674|053|H|   Read the Medication Guide provided by your pharmacist before||
1674|054|H|you start taking edoxaban and each time you get a refill. If you||
1674|055|H|have any questions, ask your doctor or pharmacist.||
1674|056|H|   Take this medication by mouth with or without food as directed||
1674|057|H|by your doctor, usually once daily. The dosage is based on your||
1674|058|H|medical condition, weight, response to treatment, and other||
1674|059|H|medications you may be taking. Be sure to tell your doctor and||
1674|060|H|pharmacist about all the products you use (including prescription||
1674|061|H|drugs, nonprescription drugs, and herbal products).||
1674|062|H|   If you have trouble swallowing the tablet whole, you may crush||
1674|063|H|the tablet and mix it with 2 to 3 ounces (60 to 90 milliliters)||
1674|064|H|of water or applesauce. Drink or eat the entire mixture right||
1674|065|H|away. Do not prepare a supply for future use.||
1674|066|H|   If you are giving this medication through a tube into the||
1674|067|H|stomach (gastric tube), ask your health care professional for||
1674|068|H|detailed instructions on how to properly mix and give it.||
1674|069|H|   Do not stop taking this medication without consulting your||
1674|070|H|doctor. Some conditions may become worse when this drug is||
1674|071|H|suddenly stopped.||
1674|072|H|   Use this medication regularly to get the most benefit from it.||
1674|073|H|To help you remember, take it at the same time each day.||
1674|074|B|||
1674|075|S|SIDE EFFECTS:  See also Warning section.||
1674|076|S|   Easy bruising or minor bleeding (such as nosebleed, bleeding||
1674|077|S|from cuts) may occur. If either of these effects lasts or gets||
1674|078|S|worse, tell your doctor or pharmacist promptly.||
1674|079|S|   Remember that this medication has been prescribed because your||
1674|080|S|doctor has judged that the benefit to you is greater than the||
1674|081|S|risk of side effects. Many people using this medication do not||
1674|082|S|have serious side effects.||
1674|083|S|   This medication can cause serious bleeding if it affects your||
1674|084|S|blood clotting proteins too much. Tell your doctor right away if||
1674|085|S|you have any signs of serious bleeding, including: nosebleeds||
1674|086|S|that happen often or don't stop, unusual||
1674|087|S|pain/swelling/discomfort, unusual bruising, prolonged bleeding||
1674|088|S|from cuts or gums, unusually heavy/prolonged menstrual flow,||
1674|089|S|pink/dark urine, coughing up blood, vomit that is bloody or looks||
1674|090|S|like coffee grounds, severe headache, dizziness/fainting, unusual||
1674|091|S|tiredness/weakness, bloody/black/tarry stools, difficulty||
1674|092|S|swallowing.||
1674|093|S|   Get medical help right away if you have any signs of very||
1674|094|S|serious bleeding, including: vision changes, confusion, trouble||
1674|095|S|speaking, weakness on one side of the body.||
1674|096|S|   A very serious allergic reaction to this drug is rare.||
1674|097|S|However, get medical help right away if you notice any symptoms||
1674|098|S|of a serious allergic reaction, including: rash, itching/swelling||
1674|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1674|100|S|breathing.||
1674|101|S|   This is not a complete list of possible side effects. If you||
1674|102|S|notice other effects not listed above, contact your doctor or||
1674|103|S|pharmacist.||
1674|104|S|   In the US -||
1674|105|S|   Call your doctor for medical advice about side effects. You||
1674|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1674|107|S|www.fda.gov/medwatch.||
1674|108|S|   In Canada - Call your doctor for medical advice about side||
1674|109|S|effects. You may report side effects to Health Canada at||
1674|110|S|1-866-234-2345.||
1674|111|B|||
1674|112|P|PRECAUTIONS:  Before taking edoxaban, tell your doctor or||
1674|113|P|pharmacist if you are allergic to it; or if you have any other||
1674|114|P|allergies. This product may contain inactive ingredients, which||
1674|115|P|can cause allergic reactions or other problems. Talk to your||
1674|116|P|pharmacist for more details.||
1674|117|P|   Before using this medication, tell your doctor or pharmacist||
1674|118|P|your medical history, especially of: liver disease, kidney||
1674|119|P|disease, bleeding problems (such as bleeding of the||
1674|120|P|stomach/intestines, bleeding in the brain), blood disorders (such||
1674|121|P|as anemia, hemophilia, thrombocytopenia), recent major||
1674|122|P|injury/surgery, frequent falls/injuries, stroke, a certain||
1674|123|P|clotting disorder (antiphospholipid syndrome).||
1674|124|P|   Before having surgery or any medical/dental procedures||
1674|125|P|(especially spinal puncture or spinal/epidural anesthesia), tell||
1674|126|P|your doctor or dentist that you are taking this medication and||
1674|127|P|about all the products you use (including prescription drugs,||
1674|128|P|nonprescription drugs, and herbal products). Your doctor or||
1674|129|P|dentist may tell you to stop taking edoxaban before your surgery.||
1674|130|P|Ask for specific instructions about stopping or starting this||
1674|131|P|medication.||
1674|132|P|   This medication may cause stomach bleeding. Daily use of||
1674|133|P|alcohol while using this medicine may increase your risk for||
1674|134|P|stomach bleeding. Limit alcoholic beverages. Ask your doctor or||
1674|135|P|pharmacist about how much alcohol you may safely drink.||
1674|136|P|   This medication can cause heavy bleeding. To lower the chance||
1674|137|P|of getting cut, bruised, or injured, use caution with sharp||
1674|138|P|objects like razors and nail cutters, and avoid activities such||
1674|139|P|as contact sports. Use an electric razor when shaving and a soft||
1674|140|P|toothbrush when brushing your teeth. If you fall or injure||
1674|141|P|yourself, especially if you hit your head, call your doctor right||
1674|142|P|away. Your doctor may need to check you.||
1674|143|P|   During pregnancy, this medication should be used only when||
1674|144|P|clearly needed. Discuss the risks and benefits with your doctor.||
1674|145|P|   It is unknown if this medication passes into breast milk.||
1674|146|P|Consult your doctor before breastfeeding.||
1674|147|B|||
1674|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1674|149|I|medications work or increase your risk for serious side effects.||
1674|150|I|This document does not contain all possible drug interactions.||
1674|151|I|Keep a list of all the products you use (including||
1674|152|I|prescription/nonprescription drugs and herbal products) and share||
1674|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
1674|154|I|the dosage of any medicines without your doctor's approval.||
1674|155|I|   Some products that may interact with this drug include:||
1674|156|I|mifepristone, other drugs that can cause bleeding/bruising||
1674|157|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
1674|158|I|ibuprofen/naproxen, "blood thinners" such as||
1674|159|I|warfarin/enoxaparin), certain antidepressants (including SSRIs||
1674|160|I|such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine).||
1674|161|I|   Other medications can affect the removal of edoxaban from your||
1674|162|I|body, which may affect how edoxaban works. One example is||
1674|163|I|rifampin, among others.||
1674|164|I|   Aspirin can increase the risk of bleeding when used with this||
1674|165|I|medication. However, if your doctor has told you to take low-dose||
1674|166|I|aspirin to prevent heart attack or stroke (usually 81-162||
1674|167|I|milligrams a day), you should keep taking the aspirin unless your||
1674|168|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1674|169|I|details.||
1674|170|B|||
1674|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1674|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1674|173|O|poison control center right away. US residents can call||
1674|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1674|175|O|Symptoms of overdose may include: bloody/black/tarry stools,||
1674|176|O|pink/dark urine, unusual/prolonged bleeding.||
1674|177|B|||
1674|178|N|NOTES:  Do not share this medication with others.||
1674|179|N|   Lab and/or medical tests (such as kidney function,||
1674|180|N|hematocrit/hemoglobin, red blood cell count) may be done while||
1674|181|N|you are taking this medication. Keep all medical and lab||
1674|182|N|appointments. Consult your doctor for more details.||
1674|183|B|||
1674|184|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1674|185|D|remember. If you don't remember until the next day, skip the||
1674|186|D|missed dose. Take your next dose at the regular time. Do not||
1674|187|D|double the dose to catch up.||
1674|188|B|||
1674|189|R|STORAGE:  Store at room temperature away from light and moisture.||
1674|190|R|Do not store in the bathroom. Keep all medications away from||
1674|191|R|children and pets.||
1674|192|R|   Do not flush medications down the toilet or pour them into a||
1674|193|R|drain unless instructed to do so. Properly discard this product||
1674|194|R|when it is expired or no longer needed. Consult your pharmacist||
1674|195|R|or local waste disposal company.||
1674|196|B|||
1674|197|M|MEDICAL ALERT:  Your condition can cause complications in a||
1674|198|M|medical emergency. For information about enrolling in MedicAlert,||
1674|199|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1674|200|B|||
1674|201|A|Information last revised May 2024.||
1674|202|A|Copyright(c) 2025 First Databank, Inc.||
1674|203|B|||
1675|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1675|002|Z|does NOT have all possible information about this product. This||
1675|003|Z|information does not assure that this product is safe, effective,||
1675|004|Z|or appropriate for you. This information is not individual||
1675|005|Z|medical advice and does not substitute for the advice of your||
1675|006|Z|health care professional. Always ask your health care||
1675|007|Z|professional for complete information about this product and your||
1675|008|Z|specific health needs.||
1675|009|B|||
1675|010|T|NAPROXEN/DIPHENHYDRAMINE - ORAL||
1675|011|F|(na-PROX-en/DYE-fen-HYE-dra-meen)||
1675|012|B|||
1675|013|C|COMMON BRAND NAME(S): Aleve PM||
1675|014|B|||
1675|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1675|016|W|naproxen) may rarely increase the risk for a heart attack or||
1675|017|W|stroke. This effect can happen at any time while taking this drug||
1675|018|W|but is more likely if you take it for a long time. The risk may||
1675|019|W|be greater in older adults or if you have heart disease or||
1675|020|W|increased risk for heart disease (for example, due to smoking,||
1675|021|W|family history of heart disease, or conditions such as high blood||
1675|022|W|pressure or diabetes). Do not take this drug right before or||
1675|023|W|after heart bypass surgery (CABG).||
1675|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
1675|025|W|from the stomach or intestines. This effect can occur without||
1675|026|W|warning at any time while taking this drug. Older adults may be||
1675|027|W|at higher risk for this effect.||
1675|028|W|   Stop taking this medication and get medical help right away if||
1675|029|W|you notice any of these rare but serious side effects:||
1675|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
1675|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1675|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
1675|033|W|side of the body, trouble speaking, sudden vision changes.||
1675|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
1675|035|W|of taking this drug.||
1675|036|B|||
1675|037|U|USES:  This product is a combination of 2 drugs: naproxen and||
1675|038|U|diphenhydramine. It is used by adults who have trouble sleeping||
1675|039|U|(insomnia) due to minor aches and pain.||
1675|040|U|   Naproxen belongs to a group of drugs known as nonsteroidal||
1675|041|U|anti-inflammatory drugs (NSAIDs). It is used to relieve minor||
1675|042|U|aches and pain from various conditions such as headache, muscle||
1675|043|U|aches, dental pain, menstrual cramps, or arthritis. It works by||
1675|044|U|blocking your body's production of certain natural substances||
1675|045|U|that cause inflammation. This effect helps to decrease swelling,||
1675|046|U|pain, or fever. Diphenhydramine is an antihistamine used in this||
1675|047|U|combination product to help you relax and fall asleep.||
1675|048|U|   If you are also treating a chronic condition such as||
1675|049|U|arthritis, ask your doctor about non-drug treatments and/or using||
1675|050|U|other medications to treat your pain. See also Warning section.||
1675|051|B|||
1675|052|H|HOW TO USE:  Read all directions on the product package before||
1675|053|H|taking this medication. If you have any questions, ask your||
1675|054|H|doctor or pharmacist.||
1675|055|H|   Take this medication by mouth as directed by your doctor or||
1675|056|H|the package label, usually 2 tablets at bedtime with a full glass||
1675|057|H|(8 ounces/240 milliliters) of water. Do not increase your dose or||
1675|058|H|take this drug more often or for longer than directed. Do not lie||
1675|059|H|down for at least 10 minutes after taking this drug to prevent||
1675|060|H|irritation inside your throat (esophagus). If this medication||
1675|061|H|upsets your stomach, you may take it with food, milk, or an||
1675|062|H|antacid.||
1675|063|H|   Do not take this medication unless you have time for a full||
1675|064|H|night's sleep of at least 7 to 8 hours. If you have to wake up||
1675|065|H|before that, you may have trouble safely doing anything that||
1675|066|H|needs alertness, such as driving or operating machinery. (See||
1675|067|H|also Precautions section.)||
1675|068|H|   If your condition lasts longer than 2 weeks, or if you think||
1675|069|H|you may have a serious medical problem, get medical help right||
1675|070|H|away.||
1675|071|B|||
1675|072|S|SIDE EFFECTS:  See also Warning section.||
1675|073|S|   Drowsiness, dizziness, stomach upset, nausea, or blurred||
1675|074|S|vision may occur. If any of these effects last or get worse, tell||
1675|075|S|your doctor or pharmacist promptly.||
1675|076|S|   If your doctor has directed you to use this medication,||
1675|077|S|remember that your doctor has judged that the benefit to you is||
1675|078|S|greater than the risk of side effects. Many people using this||
1675|079|S|medication do not have serious side effects.||
1675|080|S|   This medication may raise your blood pressure. Check your||
1675|081|S|blood pressure regularly and tell your doctor if the results are||
1675|082|S|high.||
1675|083|S|   Tell your doctor right away if you have any serious side||
1675|084|S|effects, including: easy bruising/bleeding, difficult/painful||
1675|085|S|swallowing, hearing changes (such as ringing in the ears),||
1675|086|S|mental/mood changes (such as restlessness, confusion), signs of||
1675|087|S|kidney problems (such as change in amount of urine), symptoms of||
1675|088|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
1675|089|S|unusual/sudden weight gain).||
1675|090|S|   Get medical help right away if you have any very serious side||
1675|091|S|effects, including: seizures.||
1675|092|S|   This drug may rarely cause serious (possibly fatal) liver||
1675|093|S|disease. Get medical help right away if you have any symptoms of||
1675|094|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1675|095|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1675|096|S|urine.||
1675|097|S|   A very serious allergic reaction to this drug is rare.||
1675|098|S|However, get medical help right away if you notice any symptoms||
1675|099|S|of a serious allergic reaction, including: fever, swollen lymph||
1675|100|S|nodes, rash, itching/swelling (especially of the||
1675|101|S|face/tongue/throat), severe dizziness, trouble breathing.||
1675|102|S|   This is not a complete list of possible side effects. If you||
1675|103|S|notice other effects not listed above, contact your doctor or||
1675|104|S|pharmacist.||
1675|105|S|   In the US -||
1675|106|S|   Call your doctor for medical advice about side effects. You||
1675|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1675|108|S|www.fda.gov/medwatch.||
1675|109|S|   In Canada - Call your doctor for medical advice about side||
1675|110|S|effects. You may report side effects to Health Canada at||
1675|111|S|1-866-234-2345.||
1675|112|B|||
1675|113|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1675|114|P|pharmacist if you are allergic to naproxen or diphenhydramine; or||
1675|115|P|to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if||
1675|116|P|you have any other allergies. This product may contain inactive||
1675|117|P|ingredients, which can cause allergic reactions or other||
1675|118|P|problems. Talk to your pharmacist for more details.||
1675|119|P|   Before taking this medication, tell your doctor or pharmacist||
1675|120|P|your medical history, especially of: asthma (including a history||
1675|121|P|of worsening breathing after taking aspirin or other NSAIDs),||
1675|122|P|blood disorders (such as anemia, bleeding/clotting problems),||
1675|123|P|growths in the nose (nasal polyps), personal or family history of||
1675|124|P|glaucoma (angle-closure type), heart disease (such as previous||
1675|125|P|heart attack), high blood pressure, liver disease, seizures,||
1675|126|P|stroke, esophagus/stomach/intestinal problems (such as bleeding,||
1675|127|P|heartburn, ulcers), difficulty urinating (for example, due to||
1675|128|P|enlarged prostate).||
1675|129|P|   Kidney problems can sometimes occur with the use of NSAID||
1675|130|P|medications, including naproxen. Problems are more likely to||
1675|131|P|occur if you are dehydrated, have heart failure or kidney||
1675|132|P|disease, are an older adult, or if you take certain medications||
1675|133|P|(see also Drug Interactions section). Drink plenty of fluids as||
1675|134|P|directed by your doctor to prevent dehydration and tell your||
1675|135|P|doctor right away if you have a change in the amount of urine.||
1675|136|P|   This drug may make you dizzy or drowsy or blur your vision.||
1675|137|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1675|138|P|drowsy. Do not drive, use machinery, or do anything that needs||
1675|139|P|alertness or clear vision until you can do it safely. Talk to||
1675|140|P|your doctor if you are using marijuana (cannabis).||
1675|141|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1675|142|P|and tobacco, especially when combined with this medicine, may||
1675|143|P|increase your risk for stomach bleeding. Limit alcoholic||
1675|144|P|beverages and stop smoking. Consult your doctor or pharmacist for||
1675|145|P|more information.||
1675|146|P|   This medication may make you more sensitive to the sun. Limit||
1675|147|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1675|148|P|sunscreen and wear protective clothing when outdoors. Tell your||
1675|149|P|doctor right away if you get sunburned or have skin||
1675|150|P|blisters/redness.||
1675|151|P|   Before having surgery, tell your doctor or dentist about all||
1675|152|P|the products you use (including prescription drugs,||
1675|153|P|nonprescription drugs, and herbal products).||
1675|154|P|   Older adults may be at greater risk for kidney problems, heart||
1675|155|P|attack, stroke, stomach/intestinal bleeding, trouble urinating,||
1675|156|P|drowsiness, dizziness, or confusion. Drowsiness, dizziness, and||
1675|157|P|confusion can increase the risk of falling.||
1675|158|P|   Before using this medication, women of childbearing age should||
1675|159|P|talk with their doctor(s) about the benefits and risks. Tell your||
1675|160|P|doctor if you are pregnant or if you plan to become pregnant.||
1675|161|P|This medication may harm an unborn baby and cause problems with||
1675|162|P|normal labor/delivery. It is not recommended for use in pregnancy||
1675|163|P|from 20 weeks until delivery. If your doctor decides that you||
1675|164|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1675|165|P|you should use the lowest effective dose for the shortest||
1675|166|P|possible time. You should not use this medication after 30 weeks||
1675|167|P|of pregnancy.||
1675|168|P|   This drug passes into breast milk and may have undesirable||
1675|169|P|effects on a nursing infant. Consult your doctor before||
1675|170|P|breastfeeding.||
1675|171|B|||
1675|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1675|173|I|medications work or increase your risk for serious side effects.||
1675|174|I|This document does not contain all possible drug interactions.||
1675|175|I|Keep a list of all the products you use (including||
1675|176|I|prescription/nonprescription drugs and herbal products) and share||
1675|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
1675|178|I|the dosage of any medicines without your doctor's approval.||
1675|179|I|   Some products that may interact with this drug include:||
1675|180|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1675|181|I|angiotensin II receptor blockers (such as losartan, valsartan),||
1675|182|I|antihistamines applied to the skin (such as diphenhydramine||
1675|183|I|cream, ointment, spray), cidofovir, corticosteroids (such as||
1675|184|I|prednisone), lithium, "water pills" (diuretics such as||
1675|185|I|furosemide).||
1675|186|I|   This medication may increase the risk of bleeding when taken||
1675|187|I|with other drugs that also may cause bleeding. Examples include||
1675|188|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1675|189|I|dabigatran/enoxaparin/warfarin, among others.||
1675|190|I|   Tell your doctor or pharmacist if you are taking other||
1675|191|I|products that cause drowsiness such as opioid pain or cough||
1675|192|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1675|193|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1675|194|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1675|195|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1675|196|I|chlorpheniramine).||
1675|197|I|   Check the labels on all your medicines (such as allergy or||
1675|198|I|cough-and-cold products) because they may contain ingredients||
1675|199|I|that cause drowsiness. Ask your pharmacist about using those||
1675|200|I|products safely.||
1675|201|I|   Check all prescription and nonprescription medicine labels||
1675|202|I|carefully since many medications contain pain relievers/fever||
1675|203|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
1675|204|I|ketorolac). These drugs are similar to naproxen and may increase||
1675|205|I|your risk of side effects if taken together. However, if your||
1675|206|I|doctor has told you to take low-dose aspirin to prevent heart||
1675|207|I|attack or stroke (usually 81-162 milligrams a day), you should||
1675|208|I|keep taking the aspirin unless your doctor tells you not to.||
1675|209|I|Daily use of naproxen may decrease aspirin's ability to prevent||
1675|210|I|heart attack/stroke. Talk with your doctor about the risks and||
1675|211|I|benefits. Ask about other medications that can be used to treat||
1675|212|I|pain/fever.||
1675|213|I|   This medication may interfere with certain lab tests (such as||
1675|214|I|allergy skin test), possibly causing false test results. Make||
1675|215|I|sure lab personnel and all your doctors know you use this drug.||
1675|216|B|||
1675|217|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1675|218|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1675|219|O|poison control center right away. US residents can call||
1675|220|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1675|221|O|Symptoms of overdose may include: severe stomach pain, extreme||
1675|222|O|drowsiness, seizures.||
1675|223|B|||
1675|224|N|NOTES:  Lab and/or medical tests (such as blood pressure,||
1675|225|N|complete blood count, liver/kidney function) may be done while||
1675|226|N|you are taking this medication. Keep all medical and lab||
1675|227|N|appointments. Consult your doctor for more details.||
1675|228|N|   If you have arthritis, lifestyle changes (such as weight loss||
1675|229|N|if needed, strengthening/conditioning exercises) may help improve||
1675|230|N|your flexibility and joint function. Consult your doctor for||
1675|231|N|specific instructions.||
1675|232|B|||
1675|233|D|MISSED DOSE:  Not applicable.||
1675|234|B|||
1675|235|R|STORAGE:  Store at room temperature away from light and moisture.||
1675|236|R|Do not store in the bathroom. Keep all medications away from||
1675|237|R|children and pets.||
1675|238|R|   Do not flush medications down the toilet or pour them into a||
1675|239|R|drain unless instructed to do so. Properly discard this product||
1675|240|R|when it is expired or no longer needed. Consult your pharmacist||
1675|241|R|or local waste disposal company.||
1675|242|B|||
1675|243|A|Information last revised May 2024.||
1675|244|A|Copyright(c) 2025 First Databank, Inc.||
1675|245|B|||
1676|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1676|002|Z|does NOT have all possible information about this product. This||
1676|003|Z|information does not assure that this product is safe, effective,||
1676|004|Z|or appropriate for you. This information is not individual||
1676|005|Z|medical advice and does not substitute for the advice of your||
1676|006|Z|health care professional. Always ask your health care||
1676|007|Z|professional for complete information about this product and your||
1676|008|Z|specific health needs.||
1676|009|B|||
1676|010|T|CARBIDOPA/LEVODOPA EXTENDED-RELEASE CAPSULE - ORAL||
1676|011|F|(KAR-bi-DOE-pa/LEE-voe-DOE-pa)||
1676|012|B|||
1676|013|C|COMMON BRAND NAME(S): Rytary||
1676|014|B|||
1676|015|U|USES:  This medication is used to treat the symptoms of||
1676|016|U|Parkinson's disease (such as shakiness, stiffness, difficulty||
1676|017|U|moving) or Parkinson-like conditions.||
1676|018|U|   Parkinson's disease is thought to be caused by too little of a||
1676|019|U|naturally occurring substance (dopamine) in the brain. Levodopa||
1676|020|U|changes into dopamine in the brain, helping to control movement.||
1676|021|U|Carbidopa prevents the breakdown of levodopa in the bloodstream||
1676|022|U|so more levodopa can enter the brain. Carbidopa can also reduce||
1676|023|U|some of levodopa's side effects such as nausea and vomiting.||
1676|024|B|||
1676|025|H|HOW TO USE:  Take this medication by mouth as directed by your||
1676|026|H|doctor, usually 3 times a day.||
1676|027|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
1676|028|H|Doing so can release all of the drug at once, increasing the risk||
1676|029|H|of side effects. If you have trouble swallowing the capsule, you||
1676|030|H|may open up the capsule and sprinkle the entire contents onto a||
1676|031|H|small amount (1 to 2 tablespoons or 15 to 30 grams) of||
1676|032|H|applesauce. Swallow all of the mixture right away without chewing||
1676|033|H|it. Do not prepare the mixture ahead of time for later use.||
1676|034|H|   This medication may be taken with or without food. However,||
1676|035|H|avoid high-protein diets because they may reduce how much of the||
1676|036|H|medication you can absorb. Also avoid taking this medication with||
1676|037|H|a high-fat, high-calorie meal since this can slow down the time||
1676|038|H|it begins to work by about 2 hours. The manufacturer says you||
1676|039|H|should take your first dose of the day about 1 to 2 hours before||
1676|040|H|eating. Ask your doctor or pharmacist how best to take this||
1676|041|H|medication.||
1676|042|H|   Separate your dose of this medication as many hours as||
1676|043|H|possible from any iron supplements or products containing iron||
1676|044|H|(such as multivitamins with minerals) you may take. Iron can||
1676|045|H|reduce the amount of carbidopa/levodopa that is absorbed by your||
1676|046|H|body.||
1676|047|H|   Do not take other forms of carbidopa or levodopa without||
1676|048|H|consulting your doctor first.||
1676|049|H|   Take this medication regularly to get the most benefit from||
1676|050|H|it. To help you remember, take it at the same times each day. The||
1676|051|H|dosage is based on your medical condition and response to||
1676|052|H|treatment.||
1676|053|H|   Some people may experience a "wearing-off" effect of this||
1676|054|H|medication just before the next dose is due or an "on-off" effect||
1676|055|H|at other times. If these effects occur and bother you, tell your||
1676|056|H|doctor. Do not change your dose of this or any other medication||
1676|057|H|without checking with your doctor first.||
1676|058|H|   Do not stop taking this medication without consulting your||
1676|059|H|doctor. Some conditions may become worse when this medication is||
1676|060|H|suddenly stopped. Also, if you suddenly stop using this||
1676|061|H|medication, you may have withdrawal symptoms (such as anxiety,||
1676|062|H|depression, confusion, fever, muscle stiffness). To help prevent||
1676|063|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1676|064|H|more likely if you have used this medication for a long time or||
1676|065|H|in high doses. Tell your doctor or pharmacist right away if you||
1676|066|H|have withdrawal.||
1676|067|H|   Tell your doctor if your condition does not get better or if||
1676|068|H|it gets worse.||
1676|069|B|||
1676|070|S|SIDE EFFECTS:  Dizziness, nausea, vomiting, dry mouth, trouble||
1676|071|S|sleeping, unusual dreams, or headache may occur. If any of these||
1676|072|S|effects last or get worse, tell your doctor or pharmacist||
1676|073|S|promptly.||
1676|074|S|   This medication may cause urine, sweat, or saliva to turn red,||
1676|075|S|brown, or black. This effect is harmless, but your clothes may||
1676|076|S|become stained.||
1676|077|S|   To reduce the risk of dizziness and lightheadedness, get up||
1676|078|S|slowly when rising from a sitting or lying position.||
1676|079|S|   Remember that this medication has been prescribed because your||
1676|080|S|doctor has judged that the benefit to you is greater than the||
1676|081|S|risk of side effects. Many people using this medication do not||
1676|082|S|have serious side effects.||
1676|083|S|   Some people taking this medication have fallen asleep suddenly||
1676|084|S|during their usual daily activities (such as talking on the||
1676|085|S|phone, driving). In some cases, sleep occurred without any||
1676|086|S|feelings of drowsiness beforehand. This sleep effect may occur||
1676|087|S|anytime during treatment with this medication even if you have||
1676|088|S|used this medication for a long time. If you experience increased||
1676|089|S|sleepiness or fall asleep during the day, do not drive or take||
1676|090|S|part in other possibly dangerous activities until you have||
1676|091|S|discussed this effect with your doctor. Your risk of this sleep||
1676|092|S|effect is increased by using alcohol or other medications that||
1676|093|S|can make you drowsy. See also Precautions section.||
1676|094|S|   Tell your doctor right away if you have any serious side||
1676|095|S|effects, including: mental/mood changes (such as confusion,||
1676|096|S|agitation, hallucinations), unusual strong urges (such as||
1676|097|S|increased gambling, increased sexual urges), new/worsening||
1676|098|S|movements you can't control/spasms, greatly increased eye||
1676|099|S|blinking/twitching, easy bruising/bleeding, signs of infection||
1676|100|S|(such as sore throat that doesn't go away, fever, chills),||
1676|101|S|unusual tiredness, tingling of the hands/feet, vision changes||
1676|102|S|(such as blurred/double/decreased vision), eye pain, severe||
1676|103|S|stomach/abdominal pain, vomit that looks like coffee grounds,||
1676|104|S|black/tarry stools, problems with urination.||
1676|105|S|   Get medical help right away if you have any very serious side||
1676|106|S|effects, including: chest pain, fainting.||
1676|107|S|   Suddenly stopping or reducing the dose of this medication may||
1676|108|S|rarely cause a very serious condition called neuroleptic||
1676|109|S|malignant syndrome (NMS). Get medical help right away if you have||
1676|110|S|any of the following symptoms: fever, unusual muscle stiffness,||
1676|111|S|severe confusion, sweating, fast/irregular heartbeat.||
1676|112|S|   A very serious allergic reaction to this drug is rare.||
1676|113|S|However, get medical help right away if you notice any symptoms||
1676|114|S|of a serious allergic reaction, including: rash, itching/swelling||
1676|115|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1676|116|S|breathing.||
1676|117|S|   This is not a complete list of possible side effects. If you||
1676|118|S|notice other effects not listed above, contact your doctor or||
1676|119|S|pharmacist.||
1676|120|S|   In the US -||
1676|121|S|   Call your doctor for medical advice about side effects. You||
1676|122|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1676|123|S|www.fda.gov/medwatch.||
1676|124|S|   In Canada - Call your doctor for medical advice about side||
1676|125|S|effects. You may report side effects to Health Canada at||
1676|126|S|1-866-234-2345.||
1676|127|B|||
1676|128|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1676|129|P|pharmacist if you are allergic to carbidopa or levodopa; or to||
1676|130|P|foscarbidopa or foslevodopa; or if you have any other allergies.||
1676|131|P|This product may contain inactive ingredients, which can cause||
1676|132|P|allergic reactions or other problems. Talk to your pharmacist for||
1676|133|P|more details.||
1676|134|P|   Before using this medication, tell your doctor or pharmacist||
1676|135|P|your medical history, especially of: blood disorders, breathing||
1676|136|P|problems (such as asthma, emphysema), glaucoma, heart or blood||
1676|137|P|vessel problems (such as irregular heartbeat, heart attack,||
1676|138|P|angina), kidney disease, liver disease, mental/mood disorders||
1676|139|P|(such as depression, schizophrenia), ulcers of the||
1676|140|P|stomach/intestines, seizures, sleep disorder.||
1676|141|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1676|142|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1676|143|P|machinery, or do anything that needs alertness until you can do||
1676|144|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1676|145|P|are using marijuana (cannabis). See also Side Effects section.||
1676|146|P|   Before having surgery, tell your doctor or dentist about all||
1676|147|P|the products you use (including prescription drugs,||
1676|148|P|nonprescription drugs, and herbal products).||
1676|149|P|   During pregnancy, this medication should be used only when||
1676|150|P|clearly needed. Discuss the risks and benefits with your doctor.||
1676|151|P|   Levodopa passes into breast milk. It is unknown if carbidopa||
1676|152|P|passes into breast milk. Consult your doctor before||
1676|153|P|breastfeeding.||
1676|154|B|||
1676|155|I|DRUG INTERACTIONS:  See also How to Use section.||
1676|156|I|   Drug interactions may change how your medications work or||
1676|157|I|increase your risk for serious side effects. This document does||
1676|158|I|not contain all possible drug interactions. Keep a list of all||
1676|159|I|the products you use (including prescription/nonprescription||
1676|160|I|drugs and herbal products) and share it with your doctor and||
1676|161|I|pharmacist. Do not start, stop, or change the dosage of any||
1676|162|I|medicines without your doctor's approval.||
1676|163|I|   Taking MAO inhibitors with this medication may cause a serious||
1676|164|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1676|165|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1676|166|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
1676|167|I|treatment with this medication. Most MAO inhibitors should also||
1676|168|I|not be taken for two weeks before treatment with this medication.||
1676|169|I|However, certain MAO inhibitors (rasagiline, safinamide,||
1676|170|I|selegiline) may be used with careful monitoring by your doctor.||
1676|171|I|Ask your doctor when to start or stop taking this medication.||
1676|172|I|   This medication may interfere with certain lab tests (such as||
1676|173|I|urine catecholamine/glucose/ketone tests), possibly causing false||
1676|174|I|test results. Make sure lab personnel and all your doctors know||
1676|175|I|you use this drug.||
1676|176|B|||
1676|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1676|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1676|179|O|poison control center right away. US residents can call||
1676|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1676|181|O|Symptoms of overdose may include: severe dizziness, irregular||
1676|182|O|heartbeat, mental/mood changes (such as agitation).||
1676|183|B|||
1676|184|N|NOTES:  Do not share this medication with others.||
1676|185|N|   Lab and/or medical tests (such as complete blood count,||
1676|186|N|heart/kidney/liver function, blood pressure) may be done while||
1676|187|N|you are taking this medication. Keep all medical and lab||
1676|188|N|appointments. Consult your doctor for more details.||
1676|189|B|||
1676|190|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1676|191|D|remember. If it is near the time of the next dose, skip the||
1676|192|D|missed dose. Take your next dose at the regular time. Do not||
1676|193|D|double the dose to catch up.||
1676|194|B|||
1676|195|R|STORAGE:  Store at room temperature away from light and moisture.||
1676|196|R|Do not store in the bathroom. Keep all medications away from||
1676|197|R|children and pets.||
1676|198|R|   Do not flush medications down the toilet or pour them into a||
1676|199|R|drain unless instructed to do so. Properly discard this product||
1676|200|R|when it is expired or no longer needed. Consult your pharmacist||
1676|201|R|or local waste disposal company.||
1676|202|B|||
1676|203|A|Information last revised April 2025.||
1676|204|A|Copyright(c) 2025 First Databank, Inc.||
1676|205|B|||
1678|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1678|002|Z|does NOT have all possible information about this product. This||
1678|003|Z|information does not assure that this product is safe, effective,||
1678|004|Z|or appropriate for you. This information is not individual||
1678|005|Z|medical advice and does not substitute for the advice of your||
1678|006|Z|health care professional. Always ask your health care||
1678|007|Z|professional for complete information about this product and your||
1678|008|Z|specific health needs.||
1678|009|B|||
1678|010|T|ATAZANAVIR/COBICISTAT - ORAL||
1678|011|F|(A-ta-ZAN-a-vir/koe-BIK-i-stat)||
1678|012|B|||
1678|013|C|COMMON BRAND NAME(S): Evotaz||
1678|014|B|||
1678|015|U|USES:  This drug is used with other HIV medications to help||
1678|016|U|control HIV infection. It helps to decrease the amount of HIV in||
1678|017|U|your body so your immune system can work better. This lowers your||
1678|018|U|chance of getting HIV complications (such as new infections,||
1678|019|U|cancer) and improves your quality of life. Atazanavir belongs to||
1678|020|U|a class of drugs known as protease inhibitors. Cobicistat is used||
1678|021|U|to increase ("boost") the levels of atazanavir. This helps||
1678|022|U|atazanavir work better.||
1678|023|U|   Atazanavir/cobicistat is not a cure for HIV infection. To||
1678|024|U|decrease your risk of spreading HIV disease to others, continue||
1678|025|U|to take all HIV medications exactly as prescribed by your doctor.||
1678|026|U|Use an effective barrier method (latex or polyurethane||
1678|027|U|condoms/dental dams) during sexual activity as directed by your||
1678|028|U|doctor. Do not share personal items (such as needles/syringes,||
1678|029|U|toothbrushes, and razors) that may have contacted blood or other||
1678|030|U|body fluids. Consult your doctor or pharmacist for more details.||
1678|031|B|||
1678|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1678|033|H|from your pharmacist before you start taking||
1678|034|H|atazanavir/cobicistat and each time you get a refill. If you have||
1678|035|H|any questions, ask your doctor or pharmacist.||
1678|036|H|   Take this medication by mouth with food as directed by your||
1678|037|H|doctor, usually once daily. Since this medication may cause||
1678|038|H|kidney problems, drink plenty of fluids during treatment to lower||
1678|039|H|your risk.||
1678|040|H|   If you are taking antacids or buffered forms of drugs (such as||
1678|041|H|buffered aspirin), take this medication at least 2 hours before||
1678|042|H|or 1 hour after these medications.||
1678|043|H|   It is very important to keep taking this medication (and other||
1678|044|H|HIV medications) exactly as prescribed by your doctor. Do not||
1678|045|H|skip any doses.||
1678|046|H|   For the best effect, take this medication at evenly spaced||
1678|047|H|times. To help you remember, take this medication at the same||
1678|048|H|time every day.||
1678|049|H|   Do not take more or less of this drug than prescribed or stop||
1678|050|H|taking it (or other HIV medicines) even for a short time unless||
1678|051|H|directed to do so by your doctor. Doing so may cause the amount||
1678|052|H|of virus to increase, make the infection more difficult to treat||
1678|053|H|(resistant), or worsen side effects.||
1678|054|B|||
1678|055|S|SIDE EFFECTS:  Nausea may occur. If this effect lasts or gets||
1678|056|S|worse, tell your doctor or pharmacist promptly.||
1678|057|S|   Remember that this medication has been prescribed because your||
1678|058|S|doctor has judged that the benefit to you is greater than the||
1678|059|S|risk of side effects. Many people using this medication do not||
1678|060|S|have serious side effects.||
1678|061|S|   As your immune system gets stronger, it can begin to fight off||
1678|062|S|infections you already had, possibly causing disease symptoms to||
1678|063|S|come back. You could also have symptoms if your immune system||
1678|064|S|becomes overactive. This reaction may happen at any time (soon||
1678|065|S|after starting HIV treatment or many months later). Tell your||
1678|066|S|doctor right away if you have any serious symptoms, including:||
1678|067|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1678|068|S|that doesn't go away, headaches that are severe or don't go away,||
1678|069|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1678|070|S|changes, signs of infection (such as sore throat that doesn't go||
1678|071|S|away, fever, chills, non-healing skin sores), signs of an||
1678|072|S|overactive thyroid (such as irritability, nervousness, heat||
1678|073|S|intolerance, fast/pounding/irregular heartbeat).||
1678|074|S|   Tell your doctor right away if you have any serious side||
1678|075|S|effects, including: increased thirst/urination, dizziness,||
1678|076|S|lightheadedness, signs of kidney problems (such as pain in||
1678|077|S|side/back/abdomen, painful urination, blood in the urine, change||
1678|078|S|in the amount of urine), signs of liver problems (such as||
1678|079|S|nausea/vomiting that doesn't stop, loss of appetite,||
1678|080|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1678|081|S|   Get medical help right away if you have any very serious side||
1678|082|S|effects, including: signs of a heart attack (such as||
1678|083|S|chest/jaw/left arm pain, shortness of breath, unusual sweating).||
1678|084|S|   Changes in body fat may occur while you are taking this||
1678|085|S|medication (such as increased fat in the upper back and stomach||
1678|086|S|areas, decreased fat in the arms and legs). The cause and||
1678|087|S|long-term effects of these changes are unknown. Discuss the risks||
1678|088|S|and benefits of treatment with your doctor, as well as the||
1678|089|S|possible use of exercise to reduce this side effect.||
1678|090|S|   This medication can commonly cause a rash that is usually not||
1678|091|S|serious. However, you may not be able to tell it apart from a||
1678|092|S|rare rash that could be a sign of a severe reaction. Get medical||
1678|093|S|help right away if you develop any rash.||
1678|094|S|   A very serious allergic reaction to this drug is rare.||
1678|095|S|However, get medical help right away if you notice any symptoms||
1678|096|S|of a serious allergic reaction, including: swollen lymph nodes,||
1678|097|S|rash, itching/swelling (especially of the face/tongue/throat),||
1678|098|S|severe dizziness, trouble breathing.||
1678|099|S|   This is not a complete list of possible side effects. If you||
1678|100|S|notice other effects not listed above, contact your doctor or||
1678|101|S|pharmacist.||
1678|102|S|   In the US -||
1678|103|S|   Call your doctor for medical advice about side effects. You||
1678|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1678|105|S|www.fda.gov/medwatch.||
1678|106|S|   In Canada - Call your doctor for medical advice about side||
1678|107|S|effects. You may report side effects to Health Canada at||
1678|108|S|1-866-234-2345.||
1678|109|B|||
1678|110|P|PRECAUTIONS:  Before taking atazanavir/cobicistat, tell your||
1678|111|P|doctor or pharmacist if you are allergic to atazanavir; or to||
1678|112|P|cobicistat; or if you have any other allergies. This product may||
1678|113|P|contain inactive ingredients, which can cause allergic reactions||
1678|114|P|or other problems. Talk to your pharmacist for more details.||
1678|115|P|   Before using this medication, tell your doctor or pharmacist||
1678|116|P|your medical history, especially of: liver problems (including||
1678|117|P|hepatitis B or C infections), kidney problems (including kidney||
1678|118|P|stones), heart problems (such as heart rhythm problems, irregular||
1678|119|P|heartbeat, coronary artery disease, heart attack), a certain||
1678|120|P|bleeding problem (hemophilia).||
1678|121|P|   This medication may increase the level of cholesterol and fats||
1678|122|P|(triglycerides) in your blood. HIV infection can also cause this||
1678|123|P|effect. This could increase your risk for heart problems such as||
1678|124|P|a heart attack. Discuss the risks and benefits of treatment with||
1678|125|P|your doctor and ways to lower your risk of heart disease. Tell||
1678|126|P|your doctor if you have heart problems, if you smoke, or if you||
1678|127|P|have other conditions that increase your risk of heart disease||
1678|128|P|such as high blood pressure, diabetes, or high||
1678|129|P|cholesterol/triglyceride levels.||
1678|130|P|   Before having surgery, tell your doctor or dentist about all||
1678|131|P|the products you use (including prescription drugs,||
1678|132|P|nonprescription drugs, and herbal products).||
1678|133|P|   This medication is not recommended for use during pregnancy.||
1678|134|P|It may not work well in a pregnant woman. If you become pregnant||
1678|135|P|or think you may be pregnant, tell your doctor right away. Your||
1678|136|P|doctor may change your HIV medications.||
1678|137|P|   Atazanavir passes into breast milk. It is unknown if||
1678|138|P|cobicistat passes into breast milk. Because breast milk may||
1678|139|P|transmit HIV, consult your doctor before breastfeeding.||
1678|140|B|||
1678|141|I|DRUG INTERACTIONS:  See also How to Use section.||
1678|142|I|   Drug interactions may change how your medications work or||
1678|143|I|increase your risk for serious side effects. This document does||
1678|144|I|not contain all possible drug interactions. Keep a list of all||
1678|145|I|the products you use (including prescription/nonprescription||
1678|146|I|drugs and herbal products) and share it with your doctor and||
1678|147|I|pharmacist. Do not start, stop, or change the dosage of any||
1678|148|I|medicines without your doctor's approval.||
1678|149|I|   Some products that may interact with this drug include:||
1678|150|I|drospirenone/estradiol, elvitegravir, certain medications used to||
1678|151|I|treat chronic hepatitis C (such as elbasvir/grazoprevir,||
1678|152|I|glecaprevir/pibrentasvir), orlistat, ritonavir.||
1678|153|I|   This medication can slow down the removal of other medications||
1678|154|I|from your body, which may affect how they work. Examples of||
1678|155|I|affected drugs include certain alpha blockers (such as alfuzosin,||
1678|156|I|silodosin), certain benzodiazepines (midazolam, triazolam),||
1678|157|I|dronedarone, ergot alkaloids (such as dihydroergotamine,||
1678|158|I|ergotamine), irinotecan, lurasidone, pimozide, ranolazine,||
1678|159|I|rivaroxaban, salmeterol, certain drugs to treat erectile||
1678|160|I|dysfunction-ED or pulmonary hypertension (avanafil, sildenafil),||
1678|161|I|certain "statin" cholesterol drugs (lovastatin, simvastatin),||
1678|162|I|among others.||
1678|163|I|   Other medications can affect the removal of this medication||
1678|164|I|from your body, which may affect how this medication works.||
1678|165|I|Examples include apalutamide, lumacaftor, mitotane, certain HIV||
1678|166|I|NNRTIs (such as efavirenz, etravirine, nevirapine), certain||
1678|167|I|rifamycins (such as rifampin, rifapentine), certain drugs used to||
1678|168|I|treat seizures (such as carbamazepine, phenobarbital, phenytoin,||
1678|169|I|primidone), St. John's wort, among others.||
1678|170|I|   Prescription and nonprescription drugs to treat heartburn,||
1678|171|I|indigestion, or ulcers (including H2 blockers such as famotidine,||
1678|172|I|proton pump inhibitors such as lansoprazole/omeprazole) reduce||
1678|173|I|stomach acid and decrease the absorption of atazanavir. This may||
1678|174|I|prevent atazanavir from working well. Ask your doctor or||
1678|175|I|pharmacist how to use these medications safely.||
1678|176|I|   This medication may decrease the effectiveness of hormonal||
1678|177|I|birth control such as pills, patch, or ring. This could cause||
1678|178|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1678|179|I|use reliable backup birth control methods while using this||
1678|180|I|medication. Also tell your doctor if you have any new spotting or||
1678|181|I|breakthrough bleeding, because these may be signs that your birth||
1678|182|I|control is not working well.||
1678|183|I|   Do not use this medication with other products that contain||
1678|184|I|atazanavir or cobicistat.||
1678|185|B|||
1678|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1678|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1678|188|O|poison control center right away. US residents can call||
1678|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1678|190|O|Symptoms of overdose may include: severe dizziness,||
1678|191|O|lightheadedness.||
1678|192|B|||
1678|193|N|NOTES:  Do not share this medication with others.||
1678|194|N|   Lab and/or medical tests (such as viral load, T-cell counts,||
1678|195|N|liver/kidney function, cholesterol/triglyceride levels, blood||
1678|196|N|sugar levels) should be done before you start taking this||
1678|197|N|medication and while you are taking it. Keep all medical and lab||
1678|198|N|appointments. Consult your doctor for more details.||
1678|199|B|||
1678|200|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1678|201|D|remember. If it is near the time of the next dose, skip the||
1678|202|D|missed dose. Take your next dose at the regular time. Do not||
1678|203|D|double the dose to catch up.||
1678|204|B|||
1678|205|R|STORAGE:  Store at room temperature away from light and moisture.||
1678|206|R|Do not store in the bathroom. Keep all medications away from||
1678|207|R|children and pets.||
1678|208|R|   Do not flush medications down the toilet or pour them into a||
1678|209|R|drain unless instructed to do so. Properly discard this product||
1678|210|R|when it is expired or no longer needed. Consult your pharmacist||
1678|211|R|or local waste disposal company.||
1678|212|B|||
1678|213|A|Information last revised April 2025.||
1678|214|A|Copyright(c) 2025 First Databank, Inc.||
1678|215|B|||
1679|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1679|002|Z|does NOT have all possible information about this product. This||
1679|003|Z|information does not assure that this product is safe, effective,||
1679|004|Z|or appropriate for you. This information is not individual||
1679|005|Z|medical advice and does not substitute for the advice of your||
1679|006|Z|health care professional. Always ask your health care||
1679|007|Z|professional for complete information about this product and your||
1679|008|Z|specific health needs.||
1679|009|B|||
1679|010|T|EMPAGLIFLOZIN/LINAGLIPTIN - ORAL||
1679|011|F|(EM-pa-gli-FLOE-zin/LIN-a-GLIP-tin)||
1679|012|B|||
1679|013|C|COMMON BRAND NAME(S): Glyxambi||
1679|014|B|||
1679|015|U|USES:  This medication is a combination of 2 drugs: empagliflozin||
1679|016|U|and linagliptin. It is used with a proper diet and exercise||
1679|017|U|program to control high blood sugar in people with type 2||
1679|018|U|diabetes. Controlling high blood sugar helps prevent kidney||
1679|019|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1679|020|U|function problems. Proper control of diabetes may also lessen||
1679|021|U|your risk of a heart attack or stroke. Empagliflozin works by||
1679|022|U|increasing the removal of sugar by your kidneys. Linagliptin||
1679|023|U|works by increasing levels of natural substances called||
1679|024|U|incretins. Incretins help to control blood sugar by increasing||
1679|025|U|insulin release, especially after a meal. They also decrease the||
1679|026|U|amount of sugar your liver makes.||
1679|027|B|||
1679|028|H|HOW TO USE:  Read the Medication Guide provided by your||
1679|029|H|pharmacist before you start taking this medication and each time||
1679|030|H|you get a refill. If you have any questions, ask your doctor or||
1679|031|H|pharmacist.||
1679|032|H|   Take this medication by mouth with or without food as directed||
1679|033|H|by your doctor, usually once daily in the morning. The dosage is||
1679|034|H|based on your medical condition and response to treatment.||
1679|035|H|   Use this medication regularly to get the most benefit from it.||
1679|036|H|To help you remember, take it at the same time each day.||
1679|037|H|   Tell your doctor if your condition does not get better or if||
1679|038|H|it gets worse (your blood sugar is too high or too low).||
1679|039|B|||
1679|040|S|SIDE EFFECTS:  Frequent urination, dizziness, or lightheadedness||
1679|041|S|may occur. If any of these effects last or get worse, tell your||
1679|042|S|doctor or pharmacist promptly.||
1679|043|S|   To reduce the risk of dizziness and lightheadedness, get up||
1679|044|S|slowly when rising from a sitting or lying position.||
1679|045|S|   Remember that this medication has been prescribed because your||
1679|046|S|doctor has judged that the benefit to you is greater than the||
1679|047|S|risk of side effects. Many people using this medication do not||
1679|048|S|have serious side effects.||
1679|049|S|   Tell your doctor right away if you have any serious side||
1679|050|S|effects, including: signs of a urinary tract infection (such as||
1679|051|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1679|052|S|signs of kidney problems (such as change in the amount of urine),||
1679|053|S|joint pain, unusual skin blisters, signs of heart failure (such||
1679|054|S|as shortness of breath, swelling ankles/feet, unusual tiredness,||
1679|055|S|unusual/sudden weight gain).||
1679|056|S|   Get medical help right away if you have any very serious side||
1679|057|S|effects, including: signs of disease of the pancreas (such as||
1679|058|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain||
1679|059|S|which may spread to the back), unusual tiredness, trouble||
1679|060|S|breathing.||
1679|061|S|   This medication may cause a new yeast infection in the vagina||
1679|062|S|or the penis. It may also cause a rare but very serious bacterial||
1679|063|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1679|064|S|your doctor right away if you have signs of a yeast infection in||
1679|065|S|the vagina (such as unusual vaginal||
1679|066|S|discharge/burning/itching/odor) or in the penis (such as||
1679|067|S|redness/itching/swelling of the penis, unusual discharge from the||
1679|068|S|penis). However, get medical help right away if you have any||
1679|069|S|pain/redness/swelling in or around the genital/anal area, along||
1679|070|S|with a fever or feeling unwell.||
1679|071|S|   This medication may increase the risk of lower limb amputation||
1679|072|S|(especially of the toe and foot). The risk is higher if you have||
1679|073|S|poor blood flow in the legs, nerve problems, foot ulcers, or have||
1679|074|S|had a previous amputation. To lessen the risk, check your feet||
1679|075|S|regularly and tell your doctor if you have new pain, tenderness,||
1679|076|S|sores, or ulcers on your legs or feet.||
1679|077|S|   This medication does not usually cause low blood sugar||
1679|078|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1679|079|S|prescribed with other diabetes medications, or if you do not get||
1679|080|S|enough calories from food, or if you do unusually heavy exercise.||
1679|081|S|Talk with your doctor or pharmacist about whether the dose of||
1679|082|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1679|083|S|of low blood sugar include sudden sweating, shaking, fast||
1679|084|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1679|085|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1679|086|S|treat low blood sugar. If you don't have these reliable forms of||
1679|087|S|glucose, rapidly raise your blood sugar by eating a quick source||
1679|088|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1679|089|S|juice or non-diet soda. Tell your doctor right away about the||
1679|090|S|reaction and the use of this product. To help prevent low blood||
1679|091|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1679|092|S|Check with your doctor or pharmacist to find out what you should||
1679|093|S|do if you miss a meal.||
1679|094|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1679|095|S|thirst/urination. If these symptoms occur, tell your doctor right||
1679|096|S|away. Your doctor may need to adjust your diabetes medication,||
1679|097|S|exercise program, or diet.||
1679|098|S|   This medication may cause you to become dehydrated. This can||
1679|099|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1679|100|S|dehydration. Tell your doctor or pharmacist right away if you are||
1679|101|S|not able to drink fluids as usual, or losing fluid (such as due||
1679|102|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1679|103|S|right away if you have any signs of dehydration, such as||
1679|104|S|urinating less than usual, unusual dry mouth/thirst, fast||
1679|105|S|heartbeat, or dizziness/lightheadedness/fainting.||
1679|106|S|   A very serious allergic reaction to this drug is rare.||
1679|107|S|However, get medical help right away if you notice any symptoms||
1679|108|S|of a serious allergic reaction, including: rash, itching/swelling||
1679|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1679|110|S|breathing.||
1679|111|S|   This is not a complete list of possible side effects. If you||
1679|112|S|notice other effects not listed above, contact your doctor or||
1679|113|S|pharmacist.||
1679|114|S|   In the US -||
1679|115|S|   Call your doctor for medical advice about side effects. You||
1679|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1679|117|S|www.fda.gov/medwatch.||
1679|118|S|   In Canada - Call your doctor for medical advice about side||
1679|119|S|effects. You may report side effects to Health Canada at||
1679|120|S|1-866-234-2345.||
1679|121|B|||
1679|122|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1679|123|P|pharmacist if you are allergic to empagliflozin or linagliptin;||
1679|124|P|or if you have any other allergies. This product may contain||
1679|125|P|inactive ingredients, which can cause allergic reactions or other||
1679|126|P|problems. Talk to your pharmacist for more details.||
1679|127|P|   Before using this medication, tell your doctor or pharmacist||
1679|128|P|your medical history, especially of: kidney disease (such as||
1679|129|P|being on dialysis), dehydration, disease of the pancreas||
1679|130|P|(pancreatitis), use/abuse of alcohol, stones in your gallbladder||
1679|131|P|(gallstones), low blood pressure, heart failure, high||
1679|132|P|cholesterol, yeast infections in the vagina or penis, blocked or||
1679|133|P|narrowed blood vessels, usually in the leg, nerve problems (such||
1679|134|P|as diabetic peripheral neuropathy), foot sores or ulcers,||
1679|135|P|amputation.||
1679|136|P|   You may experience blurred vision, dizziness, or drowsiness||
1679|137|P|due to extremely low or high blood sugar. Do not drive, use||
1679|138|P|machinery, or do anything that needs alertness or clear vision||
1679|139|P|until you can do it safely.||
1679|140|P|   Limit alcohol while taking this medication because it can||
1679|141|P|increase your risk of developing low blood sugar and a high||
1679|142|P|ketone level.||
1679|143|P|   It may be harder to control your blood sugar when your body is||
1679|144|P|stressed (such as due to fever, infection, injury, or surgery).||
1679|145|P|Also, if you are eating less or not able to eat due to these||
1679|146|P|conditions or any illness, this can lead to a high ketone level||
1679|147|P|while you are taking this medication. Consult your doctor because||
1679|148|P|this may require a change in your treatment plan, medications, or||
1679|149|P|blood sugar or ketone testing.||
1679|150|P|   Before having surgery, tell your doctor or dentist about all||
1679|151|P|the products you use (including prescription drugs,||
1679|152|P|nonprescription drugs, and herbal products).||
1679|153|P|   Older adults may be more sensitive to the side effects of this||
1679|154|P|drug, especially kidney problems, dehydration, dizziness, and low||
1679|155|P|blood pressure.||
1679|156|P|   During pregnancy, this medication should be used only when||
1679|157|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1679|158|P|benefits with your doctor.||
1679|159|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1679|160|P|your doctor for managing your blood sugar while pregnant. Your||
1679|161|P|doctor may change your diabetes treatment during your pregnancy||
1679|162|P|(such as diet and medications including insulin).||
1679|163|P|   It is unknown if this drug passes into breast milk. Consult||
1679|164|P|your doctor before breastfeeding.||
1679|165|B|||
1679|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1679|167|I|medications work or increase your risk for serious side effects.||
1679|168|I|This document does not contain all possible drug interactions.||
1679|169|I|Keep a list of all the products you use (including||
1679|170|I|prescription/nonprescription drugs and herbal products) and share||
1679|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
1679|172|I|the dosage of any medicines without your doctor's approval.||
1679|173|I|   Other medications can affect the removal of linagliptin from||
1679|174|I|your body, which may affect how linagliptin works. One example is||
1679|175|I|rifampin, among others.||
1679|176|I|   Beta blocker medications (such as metoprolol, propranolol,||
1679|177|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1679|178|I|heartbeat you would usually feel when your blood sugar falls too||
1679|179|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1679|180|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1679|181|I|   Many drugs can affect your blood sugar, making it harder to||
1679|182|I|control. Before you start, stop, or change any medication, talk||
1679|183|I|with your doctor or pharmacist about how the medication may||
1679|184|I|affect your blood sugar. Check your blood sugar regularly as||
1679|185|I|directed and share the results with your doctor. Tell your doctor||
1679|186|I|right away if you have symptoms of high or low blood sugar. (See||
1679|187|I|also Side Effects section.) Your doctor may need to adjust your||
1679|188|I|diabetes medication, exercise program, or diet.||
1679|189|I|   This medication may interfere with certain lab tests (such as||
1679|190|I|urine glucose test), possibly causing false test results. Make||
1679|191|I|sure lab personnel and all your doctors know you use this drug.||
1679|192|B|||
1679|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1679|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1679|195|O|poison control center right away. US residents can call||
1679|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1679|197|B|||
1679|198|N|NOTES:  Do not share this medication with others.||
1679|199|N|   Attend a diabetes education program to learn more about how to||
1679|200|N|manage your diabetes with medications, diet, exercise, and||
1679|201|N|regular medical exams.||
1679|202|N|   Learn the symptoms of high and low blood sugar and how to||
1679|203|N|treat low blood sugar. Check your blood sugar regularly as||
1679|204|N|directed.||
1679|205|N|   Lab tests (such as kidney function, blood pressure, blood||
1679|206|N|sugar, hemoglobin A1c, cholesterol, ketones) should be done while||
1679|207|N|you are taking this medication. Keep all medical and lab||
1679|208|N|appointments. Consult your doctor for more details.||
1679|209|B|||
1679|210|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1679|211|D|remember. If it is near the time of the next dose, skip the||
1679|212|D|missed dose. Take your next dose at the regular time. Do not||
1679|213|D|double the dose to catch up.||
1679|214|B|||
1679|215|R|STORAGE:  Store at room temperature away from light and moisture.||
1679|216|R|Do not store in the bathroom. Keep all medications away from||
1679|217|R|children and pets.||
1679|218|R|   Do not flush medications down the toilet or pour them into a||
1679|219|R|drain unless instructed to do so. Properly discard this product||
1679|220|R|when it is expired or no longer needed. Consult your pharmacist||
1679|221|R|or local waste disposal company.||
1679|222|B|||
1679|223|M|MEDICAL ALERT:  Your condition can cause complications in a||
1679|224|M|medical emergency. For information about enrolling in MedicAlert,||
1679|225|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1679|226|B|||
1679|227|A|Information last revised April 2025.||
1679|228|A|Copyright(c) 2025 First Databank, Inc.||
1679|229|B|||
1680|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1680|002|Z|does NOT have all possible information about this product. This||
1680|003|Z|information does not assure that this product is safe, effective,||
1680|004|Z|or appropriate for you. This information is not individual||
1680|005|Z|medical advice and does not substitute for the advice of your||
1680|006|Z|health care professional. Always ask your health care||
1680|007|Z|professional for complete information about this product and your||
1680|008|Z|specific health needs.||
1680|009|B|||
1680|010|T|CARBIDOPA/LEVODOPA SUSPENSION - INTESTINAL||
1680|011|F|(KAR-bi-DOE-pa/LEE-voe-DOE-pa)||
1680|012|B|||
1680|013|C|COMMON BRAND NAME(S): Duopa||
1680|014|B|||
1680|015|U|USES:  This medication is used to treat symptoms of Parkinson's||
1680|016|U|disease (such as shakiness, stiffness, difficulty moving).||
1680|017|U|   Parkinson's disease is thought to be caused by too little of a||
1680|018|U|naturally occurring substance (dopamine) in the brain. Levodopa||
1680|019|U|changes into dopamine in the brain, helping to control movement.||
1680|020|U|Carbidopa prevents the breakdown of levodopa in the bloodstream||
1680|021|U|so more levodopa can enter the brain. Carbidopa can also reduce||
1680|022|U|some of levodopa's side effects such as nausea and vomiting.||
1680|023|U|   By giving this medication as a continuous infusion, it can||
1680|024|U|help reduce the amount of "off" time (periods of slow movement or||
1680|025|U|stiffness).||
1680|026|B|||
1680|027|H|HOW TO USE:  Read the Medication Guide and the Instructions for||
1680|028|H|Use provided by your health care professional before you start||
1680|029|H|using this medication and each time you get a refill. If you have||
1680|030|H|any questions, ask your health care professional.||
1680|031|H|   Give this medication as directed as a continuous infusion into||
1680|032|H|the small intestine using an infusion pump. It is usually given||
1680|033|H|over 16 hours a day and stopped at bedtime. At bedtime, take your||
1680|034|H|dose of immediate-release carbidopa/levodopa tablets by mouth as||
1680|035|H|directed.||
1680|036|H|   When you first start using this medication, it is given||
1680|037|H|through a tube through the nose into the small intestine. After a||
1680|038|H|few days, if the doctor decides that this product is right for||
1680|039|H|you, then the medication will be given through a tube through the||
1680|040|H|abdomen into the small intestine. Getting the tube through the||
1680|041|H|abdomen will require surgery.||
1680|042|H|   Follow all instructions from your health care professional||
1680|043|H|about how to properly use this medication and the infusion pump.||
1680|044|H|Take a cassette containing the medication from the refrigerator||
1680|045|H|and leave it at room temperature for 20 minutes before using. Do||
1680|046|H|not use a cassette for longer than 16 hours or re-use it, even if||
1680|047|H|there is medication left in it. Learn how to store and discard||
1680|048|H|medical supplies safely. Also learn how to properly care for the||
1680|049|H|small hole in your abdomen and the skin area around the tube, and||
1680|050|H|how to avoid infection.||
1680|051|H|   The dosage is based on your medical condition and response to||
1680|052|H|treatment. Your daily dose is made up of a morning dose, a||
1680|053|H|continuous dose, and extra doses. An extra dose is a small dose||
1680|054|H|of this medication that can be given as needed during the day to||
1680|055|H|treat sudden "off" symptoms. Extra doses should not be given more||
1680|056|H|often than one every 2 hours to avoid causing or worsening||
1680|057|H|movements you cannot control.||
1680|058|H|   It is best to avoid a high-protein diet (it decreases the||
1680|059|H|amount of levodopa that your body takes in) during treatment,||
1680|060|H|unless directed otherwise by your doctor. Separate your dose of||
1680|061|H|this medication by as many hours as possible from any iron||
1680|062|H|supplements or products containing iron (such as multivitamins||
1680|063|H|with minerals) you may take. Iron can reduce the amount of this||
1680|064|H|medication absorbed by the body. Consult your doctor or||
1680|065|H|pharmacist for more details.||
1680|066|H|   Do not stop using this medication without consulting your||
1680|067|H|doctor. Some conditions may become worse when this medication is||
1680|068|H|suddenly stopped. Also, if you suddenly stop using this||
1680|069|H|medication, you may have withdrawal symptoms (such as anxiety,||
1680|070|H|depression, confusion, fever, muscle stiffness). To help prevent||
1680|071|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1680|072|H|more likely if you have used this medication for a long time or||
1680|073|H|in high doses. Tell your doctor or pharmacist right away if you||
1680|074|H|have withdrawal.||
1680|075|H|   If you plan to be disconnected from the pump for a short||
1680|076|H|period of time (less than 2 hours, for example, to shower), ask||
1680|077|H|your doctor ahead of time if you should use an extra dose of this||
1680|078|H|medication before you disconnect. If you plan to be disconnected||
1680|079|H|from the pump for longer than 2 hours, ask your doctor what you||
1680|080|H|should do and discuss how you should take carbidopa/levodopa||
1680|081|H|tablets by mouth during this time.||
1680|082|H|   Tell your doctor if your condition does not get better or if||
1680|083|H|it gets worse.||
1680|084|B|||
1680|085|S|SIDE EFFECTS:  Dizziness, nausea, vomiting, trouble sleeping, and||
1680|086|S|headache may occur. If any of these effects last or get worse,||
1680|087|S|tell your doctor or pharmacist promptly.||
1680|088|S|   This medication may cause urine, sweat, or saliva to turn red,||
1680|089|S|brown, or black. This effect is harmless, but your clothes may||
1680|090|S|become stained.||
1680|091|S|   To reduce the risk of dizziness and lightheadedness, get up||
1680|092|S|slowly when rising from a sitting or lying position.||
1680|093|S|   Remember that this medication has been prescribed because your||
1680|094|S|doctor has judged that the benefit to you is greater than the||
1680|095|S|risk of side effects. Many people using this medication do not||
1680|096|S|have serious side effects.||
1680|097|S|   Some people using this medication have fallen asleep suddenly||
1680|098|S|during their usual daily activities (such as talking on the||
1680|099|S|phone, driving). In some cases, sleep occurred without any||
1680|100|S|feelings of drowsiness beforehand. This sleep effect may occur||
1680|101|S|anytime during treatment with this medication even if you have||
1680|102|S|used this medication for a long time. If you experience increased||
1680|103|S|sleepiness or fall asleep during the day, do not drive or take||
1680|104|S|part in other possibly dangerous activities until you have||
1680|105|S|discussed this effect with your doctor. Your risk of this sleep||
1680|106|S|effect is increased by using alcohol or other medications that||
1680|107|S|can make you drowsy. (See also Precautions section.)||
1680|108|S|   Tell your doctor right away if you have any serious side||
1680|109|S|effects, including: mental/mood changes (such as confusion,||
1680|110|S|agitation, hallucinations), unusual strong urges (such as||
1680|111|S|increased gambling, increased sexual urges), new/worsening||
1680|112|S|movements you can't control/spasms, greatly increased eye||
1680|113|S|blinking/twitching, easy bruising/bleeding, unusual tiredness,||
1680|114|S|tingling/numbness/weakness of the hands/feet, vision changes||
1680|115|S|(such as blurred/double/decreased vision), eye pain.||
1680|116|S|   This medication may raise your blood pressure. Check your||
1680|117|S|blood pressure regularly and tell your doctor if the results are||
1680|118|S|high.||
1680|119|S|   Get medical help right away if you have any very serious side||
1680|120|S|effects, including: constipation that doesn't go away,||
1680|121|S|nausea/vomiting that doesn't stop, vomit that looks like coffee||
1680|122|S|grounds, bloody/black/tarry stools, stomach/abdominal pain, signs||
1680|123|S|of infection (such as sore throat that doesn't go away, fever,||
1680|124|S|chills), redness/swelling/pain/oozing around the tube site, chest||
1680|125|S|pain, fainting.||
1680|126|S|   Suddenly stopping or reducing the dose of this medication may||
1680|127|S|rarely cause a very serious condition called neuroleptic||
1680|128|S|malignant syndrome (NMS). Get medical help right away if you have||
1680|129|S|any of the following symptoms: fever, unusual muscle stiffness,||
1680|130|S|severe confusion, sweating, fast/irregular heartbeat.||
1680|131|S|   A very serious allergic reaction to this drug is rare.||
1680|132|S|However, get medical help right away if you notice any symptoms||
1680|133|S|of a serious allergic reaction, including: rash, itching/swelling||
1680|134|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1680|135|S|breathing.||
1680|136|S|   This is not a complete list of possible side effects. If you||
1680|137|S|notice other effects not listed above, contact your doctor or||
1680|138|S|pharmacist.||
1680|139|S|   In the US -||
1680|140|S|   Call your doctor for medical advice about side effects. You||
1680|141|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1680|142|S|www.fda.gov/medwatch.||
1680|143|S|   In Canada - Call your doctor for medical advice about side||
1680|144|S|effects. You may report side effects to Health Canada at||
1680|145|S|1-866-234-2345.||
1680|146|B|||
1680|147|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1680|148|P|pharmacist if you are allergic to carbidopa or levodopa; or to||
1680|149|P|foscarbidopa or foslevodopa; or if you have any other allergies.||
1680|150|P|This product may contain inactive ingredients, which can cause||
1680|151|P|allergic reactions or other problems. Talk to your pharmacist for||
1680|152|P|more details.||
1680|153|P|   Before using this medication, tell your doctor or pharmacist||
1680|154|P|your medical history, especially of: bleeding disorders,||
1680|155|P|breathing problems (such as asthma, emphysema), glaucoma, heart||
1680|156|P|or blood vessel problems (such as irregular heartbeat, heart||
1680|157|P|attack, angina), high blood pressure, kidney disease, liver||
1680|158|P|disease, mental/mood disorders (such as depression,||
1680|159|P|schizophrenia), numbness/tingling of the hands/feet, seizures,||
1680|160|P|sleep disorder, stomach/intestinal problems (such as ulcers, past||
1680|161|P|stomach/abdominal surgery).||
1680|162|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1680|163|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1680|164|P|machinery, or do anything that needs alertness until you can do||
1680|165|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1680|166|P|are using marijuana (cannabis). (See also Side Effects section.)||
1680|167|P|   Before having surgery, tell your doctor or dentist about all||
1680|168|P|the products you use (including prescription drugs,||
1680|169|P|nonprescription drugs, and herbal products).||
1680|170|P|   During pregnancy, this medication should be used only when||
1680|171|P|clearly needed. Discuss the risks and benefits with your doctor.||
1680|172|P|   Levodopa passes into breast milk. It is unknown if carbidopa||
1680|173|P|passes into breast milk. Consult your doctor before||
1680|174|P|breastfeeding.||
1680|175|B|||
1680|176|I|DRUG INTERACTIONS:  See also How to Use section.||
1680|177|I|   Drug interactions may change how your medications work or||
1680|178|I|increase your risk for serious side effects. This document does||
1680|179|I|not contain all possible drug interactions. Keep a list of all||
1680|180|I|the products you use (including prescription/nonprescription||
1680|181|I|drugs and herbal products) and share it with your doctor and||
1680|182|I|pharmacist. Do not start, stop, or change the dosage of any||
1680|183|I|medicines without your doctor's approval.||
1680|184|I|   Taking MAO inhibitors with this medication may cause a serious||
1680|185|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1680|186|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1680|187|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
1680|188|I|treatment with this medication. Most MAO inhibitors should also||
1680|189|I|not be taken for two weeks before treatment with this medication.||
1680|190|I|However, certain MAO inhibitors (rasagiline, safinamide,||
1680|191|I|selegiline) may be used with careful monitoring by your doctor.||
1680|192|I|Ask your doctor when to start or stop taking this medication.||
1680|193|I|   This medication may interfere with certain lab tests (such as||
1680|194|I|urine catecholamine/glucose/ketone tests), possibly causing false||
1680|195|I|test results. Make sure lab personnel and all your doctors know||
1680|196|I|you use this drug.||
1680|197|B|||
1680|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1680|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1680|200|O|poison control center right away. US residents can call||
1680|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1680|202|O|Symptoms of overdose may include: severe dizziness, irregular||
1680|203|O|heartbeat, mental/mood changes (such as agitation).||
1680|204|B|||
1680|205|N|NOTES:  Do not share this medication with others.||
1680|206|N|   Lab and/or medical tests (such as complete blood count,||
1680|207|N|heart/kidney/liver function, blood pressure) should be done while||
1680|208|N|you are using this medication. Keep all medical and lab||
1680|209|N|appointments. Consult your doctor for more details.||
1680|210|B|||
1680|211|D|MISSED DOSE:  This drug is to be given continuously as an||
1680|212|D|infusion throughout the day, usually stopping at bedtime. If your||
1680|213|D|infusion is interrupted, contact your doctor or pharmacist right||
1680|214|D|away.||
1680|215|B|||
1680|216|R|STORAGE:  Store the cassettes in the refrigerator. Keep them in||
1680|217|R|the carton to protect them from light until ready to use. Do not||
1680|218|R|freeze. (See also How to Use section.) Keep all medications away||
1680|219|R|from children and pets.||
1680|220|R|   Do not flush medications down the toilet or pour them into a||
1680|221|R|drain unless instructed to do so. Properly discard this product||
1680|222|R|when it is expired or no longer needed. Consult your pharmacist||
1680|223|R|or local waste disposal company.||
1680|224|B|||
1680|225|A|Information last revised April 2025.||
1680|226|A|Copyright(c) 2025 First Databank, Inc.||
1680|227|B|||
1681|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1681|002|Z|does NOT have all possible information about this product. This||
1681|003|Z|information does not assure that this product is safe, effective,||
1681|004|Z|or appropriate for you. This information is not individual||
1681|005|Z|medical advice and does not substitute for the advice of your||
1681|006|Z|health care professional. Always ask your health care||
1681|007|Z|professional for complete information about this product and your||
1681|008|Z|specific health needs.||
1681|009|B|||
1681|010|T|PALBOCICLIB - ORAL||
1681|011|F|(PAL-boe-SYE-klib)||
1681|012|B|||
1681|013|C|COMMON BRAND NAME(S): Ibrance||
1681|014|B|||
1681|015|U|USES:  Palbociclib is used to treat a certain type of breast||
1681|016|U|cancer. It works by slowing or stopping the growth of cancer||
1681|017|U|cells.||
1681|018|B|||
1681|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1681|020|H|from your pharmacist before you start taking palbociclib and each||
1681|021|H|time you get a refill. If you have any questions, ask your doctor||
1681|022|H|or pharmacist.||
1681|023|H|   Take this medication by mouth as directed by your doctor,||
1681|024|H|usually once daily for 21 days, then stopping the medication for||
1681|025|H|7 days. This is one cycle of treatment. Keep taking the||
1681|026|H|medication this way as directed by your doctor.||
1681|027|H|   This medication comes in a capsule or tablet. The capsule||
1681|028|H|should be taken with food while the tablet can be taken with or||
1681|029|H|without food. Swallow the medication whole. Do not crush or chew,||
1681|030|H|or open the capsules, or split the tablets.||
1681|031|H|   Do not take capsules or tablets that are broken or look||
1681|032|H|damaged. If you vomit after taking the medication, do not take||
1681|033|H|another dose of the medication that day. Take the next dose at||
1681|034|H|the usual time the next day.||
1681|035|H|   The dosage is based on your medical condition, lab tests,||
1681|036|H|response to treatment, and other medications you may be taking.||
1681|037|H|Be sure to tell your doctor and pharmacist about all the products||
1681|038|H|you use (including prescription drugs, nonprescription drugs, and||
1681|039|H|herbal products). Your doctor may stop your medication for a||
1681|040|H|while or reduce your dose if you get any side effects. Talk to||
1681|041|H|your doctor for more details.||
1681|042|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1681|043|H|using this medication unless your doctor or pharmacist says you||
1681|044|H|may do so safely. Grapefruit can increase the chance of side||
1681|045|H|effects with this medicine. Ask your doctor or pharmacist for||
1681|046|H|more details.||
1681|047|H|   Use this medication regularly to get the most benefit from it.||
1681|048|H|To help you remember, take it at the same time on the days you||
1681|049|H|are scheduled to take the medication.||
1681|050|H|   Do not increase your dose or use this drug more often or for||
1681|051|H|longer than prescribed. Your condition will not improve any||
1681|052|H|faster, and your risk of serious side effects will increase.||
1681|053|H|   Since this drug can be absorbed through the skin and lungs and||
1681|054|H|may harm an unborn baby, women who are pregnant or who may become||
1681|055|H|pregnant should not handle this medication or breathe the dust||
1681|056|H|from the capsules.||
1681|057|B|||
1681|058|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, diarrhea,||
1681|059|S|tiredness, weakness, hair loss, mouth sores, or numbness/tingling||
1681|060|S|of arms/legs may occur. If any of these effects last or get||
1681|061|S|worse, tell your doctor or pharmacist promptly.||
1681|062|S|   People using this medication may have serious side effects.||
1681|063|S|However, you have been prescribed this drug because your doctor||
1681|064|S|has judged that the benefit to you is greater than the risk of||
1681|065|S|side effects. Careful monitoring by your doctor may decrease your||
1681|066|S|risk.||
1681|067|S|   Tell your doctor right away if you have any serious side||
1681|068|S|effects, including: signs of anemia (such as unusual tiredness,||
1681|069|S|pale skin, fast heartbeat), easy bruising/bleeding (such as||
1681|070|S|nosebleed), signs of lung problems (such as chest pain, shortness||
1681|071|S|of breath).||
1681|072|S|   This medication may lower your ability to fight infections.||
1681|073|S|This may make you more likely to get a serious infection or make||
1681|074|S|any infection you have worse. Tell your doctor right away if you||
1681|075|S|have any signs of infection (such as sore throat that doesn't go||
1681|076|S|away, fever, chills).||
1681|077|S|   A very serious allergic reaction to this drug is rare.||
1681|078|S|However, get medical help right away if you notice any symptoms||
1681|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1681|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1681|081|S|breathing.||
1681|082|S|   This is not a complete list of possible side effects. If you||
1681|083|S|notice other effects not listed above, contact your doctor or||
1681|084|S|pharmacist.||
1681|085|S|   In the US -||
1681|086|S|   Call your doctor for medical advice about side effects. You||
1681|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1681|088|S|www.fda.gov/medwatch.||
1681|089|S|   In Canada - Call your doctor for medical advice about side||
1681|090|S|effects. You may report side effects to Health Canada at||
1681|091|S|1-866-234-2345.||
1681|092|B|||
1681|093|P|PRECAUTIONS:  Before taking palbociclib, tell your doctor or||
1681|094|P|pharmacist if you are allergic to it; or if you have any other||
1681|095|P|allergies. This product may contain inactive ingredients, which||
1681|096|P|can cause allergic reactions or other problems. Talk to your||
1681|097|P|pharmacist for more details.||
1681|098|P|   Before using this medication, tell your doctor or pharmacist||
1681|099|P|your medical history, especially of: liver disease.||
1681|100|P|   Palbociclib can make you more likely to get infections or may||
1681|101|P|make current infections worse. Stay away from anyone who has an||
1681|102|P|infection that may easily spread (such as chickenpox, COVID-19,||
1681|103|P|measles, flu). Talk to your doctor if you have been exposed to an||
1681|104|P|infection or for more details.||
1681|105|P|   Tell your health care professional that you are using||
1681|106|P|palbociclib before having any immunizations/vaccinations. Avoid||
1681|107|P|contact with people who have recently received live vaccines||
1681|108|P|(such as flu vaccine inhaled through the nose).||
1681|109|P|   To lower the chance of getting cut, bruised, or injured, use||
1681|110|P|caution with sharp objects like razors and nail cutters, and||
1681|111|P|avoid activities such as contact sports.||
1681|112|P|   Before having surgery, tell your doctor or dentist about all||
1681|113|P|the products you use (including prescription drugs,||
1681|114|P|nonprescription drugs, and herbal products).||
1681|115|P|   This medication can affect fertility in males. Ask your doctor||
1681|116|P|for more details.||
1681|117|P|   Tell your doctor if you are pregnant or plan to become||
1681|118|P|pregnant. You should not become pregnant while using palbociclib.||
1681|119|P|Palbociclib may harm an unborn baby. Your doctor should order a||
1681|120|P|pregnancy test before you start this medication. Women using this||
1681|121|P|medication should ask about reliable forms of birth control||
1681|122|P|during treatment and for at least 3 weeks after the last dose.||
1681|123|P|Men using this medication should ask about reliable forms of||
1681|124|P|birth control during treatment and for 3 months after the last||
1681|125|P|dose. If you or your partner becomes pregnant, talk to your||
1681|126|P|doctor right away about the risks and benefits of this||
1681|127|P|medication.||
1681|128|P|   Since this drug can be absorbed through the skin and lungs and||
1681|129|P|may harm an unborn baby, women who are pregnant or who may become||
1681|130|P|pregnant should not handle this medication or breathe the dust||
1681|131|P|from the capsules.||
1681|132|P|   It is unknown if this drug passes into breast milk. Because of||
1681|133|P|the possible risk to the infant, breastfeeding is not recommended||
1681|134|P|while using this drug and for at least 3 weeks after the last||
1681|135|P|dose. Consult your doctor before breastfeeding.||
1681|136|B|||
1681|137|I|DRUG INTERACTIONS:  See also How to Use section.||
1681|138|I|   Drug interactions may change how your medications work or||
1681|139|I|increase your risk for serious side effects. This document does||
1681|140|I|not contain all possible drug interactions. Keep a list of all||
1681|141|I|the products you use (including prescription/nonprescription||
1681|142|I|drugs and herbal products) and share it with your doctor and||
1681|143|I|pharmacist. Do not start, stop, or change the dosage of any||
1681|144|I|medicines without your doctor's approval.||
1681|145|I|   Other medications can affect the removal of palbociclib from||
1681|146|I|your body, which may affect how palbociclib works. Examples||
1681|147|I|include azole antifungals (such as itraconazole, ketoconazole),||
1681|148|I|carbamazepine, phenytoin, rifamycins (such as rifampin), St.||
1681|149|I|John's wort, among others.||
1681|150|B|||
1681|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1681|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1681|153|O|poison control center right away. US residents can call||
1681|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1681|155|B|||
1681|156|N|NOTES:  Do not share this medication with others.||
1681|157|N|   Lab and/or medical tests (such as complete blood count) should||
1681|158|N|be done before you start taking this medication and while you are||
1681|159|N|taking it. Keep all medical and lab appointments.||
1681|160|B|||
1681|161|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1681|162|D|next dose at the regular time the next day. Do not double the||
1681|163|D|dose to catch up.||
1681|164|B|||
1681|165|R|STORAGE:  Store at room temperature away from light and moisture.||
1681|166|R|Do not store in the bathroom. Keep all medications away from||
1681|167|R|children and pets.||
1681|168|R|   Do not flush medications down the toilet or pour them into a||
1681|169|R|drain unless instructed to do so. Properly discard this product||
1681|170|R|when it is expired or no longer needed. Consult your pharmacist||
1681|171|R|or local waste disposal company.||
1681|172|B|||
1681|173|M|MEDICAL ALERT:  Your condition can cause complications in a||
1681|174|M|medical emergency. For information about enrolling in MedicAlert,||
1681|175|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1681|176|B|||
1681|177|A|Information last revised April 2025.||
1681|178|A|Copyright(c) 2025 First Databank, Inc.||
1681|179|B|||
1682|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1682|002|Z|does NOT have all possible information about this product. This||
1682|003|Z|information does not assure that this product is safe, effective,||
1682|004|Z|or appropriate for you. This information is not individual||
1682|005|Z|medical advice and does not substitute for the advice of your||
1682|006|Z|health care professional. Always ask your health care||
1682|007|Z|professional for complete information about this product and your||
1682|008|Z|specific health needs.||
1682|009|B|||
1682|010|T|SECUKINUMAB - SUBCUTANEOUS INJECTION||
1682|011|F|(SEK-ue-KIN-ue-mab)||
1682|012|B|||
1682|013|C|COMMON BRAND NAME(S): Cosentyx||
1682|014|B|||
1682|015|U|USES:  This medication is used to treat plaque psoriasis and||
1682|016|U|certain types of arthritis (such as arthritis of the spine,||
1682|017|U|psoriatic arthritis, axial spondyloarthritis, enthesitis-related||
1682|018|U|arthritis). It is also used to treat a certain skin disorder||
1682|019|U|(hidradenitis suppurativa). Secukinumab belongs to a class of||
1682|020|U|drugs known as monoclonal antibodies. It works by blocking a||
1682|021|U|certain natural protein in your body (interleukin-17A) that may||
1682|022|U|cause inflammation and swelling.||
1682|023|B|||
1682|024|H|HOW TO USE:  Read the Medication Guide and the Instructions for||
1682|025|H|Use leaflet provided by your pharmacist before you start using||
1682|026|H|secukinumab and each time you get a refill. Ask your health care||
1682|027|H|professional how to prepare and use this medication. If you have||
1682|028|H|any questions, ask your doctor or pharmacist.||
1682|029|H|   Before treatment with this medication, your doctor will make||
1682|030|H|sure that you have received all your vaccinations and also test||
1682|031|H|you for tuberculosis (TB). Your doctor should monitor you for||
1682|032|H|symptoms of TB during and after treatment with this drug. If||
1682|033|H|needed, treatment for tuberculosis or other infections should be||
1682|034|H|given before receiving this medication.||
1682|035|H|   Inject this medication under your skin as directed by your||
1682|036|H|doctor. The injection is given in the upper arms, thighs, or||
1682|037|H|abdomen (at least 2 inches from your belly button). The dosage is||
1682|038|H|based on your medical condition and response to treatment.||
1682|039|H|Children's dosage is also based on weight.||
1682|040|H|   Depending on your product, take the medication out of the||
1682|041|H|refrigerator 15 to 45 minutes before you inject it to allow it to||
1682|042|H|reach room temperature. Do not shake the medication. Before||
1682|043|H|using, check this product for cloudiness, particles, or||
1682|044|H|discoloration. If you see any of these things, do not use the||
1682|045|H|liquid. Before injecting each dose, clean the skin you are going||
1682|046|H|to inject into (the injection site) with rubbing alcohol. Change||
1682|047|H|the injection site each time to lessen injury under the skin. Do||
1682|048|H|not inject into skin with scars or stretch marks or that is||
1682|049|H|irritated, sore, bruised, red, hardened, or affected by||
1682|050|H|psoriasis. To lessen bruising, do not rub the injection site||
1682|051|H|after a shot. Learn how to store and discard medical supplies||
1682|052|H|safely.||
1682|053|H|   Use this medication regularly to get the most benefit from it.||
1682|054|H|To help you remember, mark your calendar with a reminder.||
1682|055|H|   Tell your doctor if your condition does not get better or if||
1682|056|H|it gets worse.||
1682|057|B|||
1682|058|S|SIDE EFFECTS:  Diarrhea may occur. If this effect lasts or gets||
1682|059|S|worse, tell your doctor or pharmacist promptly.||
1682|060|S|   Remember that this medication has been prescribed because your||
1682|061|S|doctor has judged that the benefit to you is greater than the||
1682|062|S|risk of side effects. Many people using this medication do not||
1682|063|S|have serious side effects.||
1682|064|S|   This medication may lower your ability to fight infections.||
1682|065|S|This may make you more likely to get a serious infection or make||
1682|066|S|any infection you have worse. Tell your doctor right away if you||
1682|067|S|have any signs of infection (such as sore throat that doesn't go||
1682|068|S|away, fever, chills, white patches in the mouth).||
1682|069|S|   Tell your doctor right away if you have any serious side||
1682|070|S|effects, including: stomach/abdominal pain, diarrhea with||
1682|071|S|blood/mucus.||
1682|072|S|   A very serious allergic reaction to this drug is rare.||
1682|073|S|However, get medical help right away if you notice any symptoms||
1682|074|S|of a serious allergic reaction, including: rash, itching/swelling||
1682|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1682|076|S|breathing.||
1682|077|S|   This is not a complete list of possible side effects. If you||
1682|078|S|notice other effects not listed above, contact your doctor or||
1682|079|S|pharmacist.||
1682|080|S|   In the US -||
1682|081|S|   Call your doctor for medical advice about side effects. You||
1682|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1682|083|S|www.fda.gov/medwatch.||
1682|084|S|   In Canada - Call your doctor for medical advice about side||
1682|085|S|effects. You may report side effects to Health Canada at||
1682|086|S|1-866-234-2345.||
1682|087|B|||
1682|088|P|PRECAUTIONS:  Before using secukinumab, tell your doctor or||
1682|089|P|pharmacist if you are allergic to it; or if you have any other||
1682|090|P|allergies. This product may contain inactive ingredients (such as||
1682|091|P|latex found in the needle cover on the prefilled syringe/pen),||
1682|092|P|which can cause allergic reactions or other problems. Talk to||
1682|093|P|your pharmacist for more details.||
1682|094|P|   Before using this medication, tell your doctor or pharmacist||
1682|095|P|your medical history, especially of: current/recent/returning||
1682|096|P|infection (such as tuberculosis, herpes, hepatitis), bowel||
1682|097|P|disease (such as Crohn's disease, ulcerative colitis).||
1682|098|P|   Secukinumab can make you more likely to get infections or may||
1682|099|P|make current infections worse. Stay away from anyone who has an||
1682|100|P|infection that may easily spread (such as chickenpox, COVID-19,||
1682|101|P|measles, flu). Talk to your doctor if you have been exposed to an||
1682|102|P|infection or for more details.||
1682|103|P|   Tell your health care professional that you are using||
1682|104|P|secukinumab before having any immunizations/vaccinations. Avoid||
1682|105|P|contact with people who have recently received live vaccines||
1682|106|P|(such as flu vaccine inhaled through the nose).||
1682|107|P|   Before having surgery, tell your doctor or dentist about all||
1682|108|P|the products you use (including prescription drugs,||
1682|109|P|nonprescription drugs, and herbal products).||
1682|110|P|   During pregnancy, this medication should be used only when||
1682|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
1682|112|P|   It is unknown if this medication passes into breast milk.||
1682|113|P|Consult your doctor before breastfeeding.||
1682|114|B|||
1682|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1682|116|I|medications work or increase your risk for serious side effects.||
1682|117|I|This document does not contain all possible drug interactions.||
1682|118|I|Keep a list of all the products you use (including||
1682|119|I|prescription/nonprescription drugs and herbal products) and share||
1682|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1682|121|I|the dosage of any medicines without your doctor's approval.||
1682|122|B|||
1682|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1682|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1682|125|O|poison control center right away. US residents can call||
1682|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1682|127|B|||
1682|128|N|NOTES:  Do not share this medication with others.||
1682|129|N|   Lab and/or medical tests (such as complete blood count) may be||
1682|130|N|done while you are using this medication. Keep all medical and||
1682|131|N|lab appointments. Consult your doctor for more details.||
1682|132|B|||
1682|133|D|MISSED DOSE:  It is important to get each dose of this medication||
1682|134|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1682|135|D|right away for a new dosing schedule. Do not double the dose to||
1682|136|D|catch up.||
1682|137|B|||
1682|138|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1682|139|R|medication in the original carton to protect from light. Some||
1682|140|R|forms of this medication may also be stored at room temperature||
1682|141|R|if needed. If the medication is stored at room temperature,||
1682|142|R|discard after 4 days. Check the product package to see if that||
1682|143|R|applies to your product. Otherwise, the medication should be used||
1682|144|R|within 1 hour after taking it out of the refrigerator. Discard||
1682|145|R|any unused portion after use. Keep all medications away from||
1682|146|R|children and pets.||
1682|147|R|   Do not flush medications down the toilet or pour them into a||
1682|148|R|drain unless instructed to do so. Properly discard this product||
1682|149|R|when it is expired or no longer needed. Consult your pharmacist||
1682|150|R|or local waste disposal company.||
1682|151|B|||
1682|152|A|Information last revised April 2025.||
1682|153|A|Copyright(c) 2025 First Databank, Inc.||
1682|154|B|||
1683|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1683|002|Z|does NOT have all possible information about this product. This||
1683|003|Z|information does not assure that this product is safe, effective,||
1683|004|Z|or appropriate for you. This information is not individual||
1683|005|Z|medical advice and does not substitute for the advice of your||
1683|006|Z|health care professional. Always ask your health care||
1683|007|Z|professional for complete information about this product and your||
1683|008|Z|specific health needs.||
1683|009|B|||
1683|010|T|LENVATINIB - ORAL||
1683|011|F|(len-VA-ti-nib)||
1683|012|B|||
1683|013|C|COMMON BRAND NAME(S): Lenvima||
1683|014|B|||
1683|015|U|USES:  This medication is used to treat cancer. Lenvatinib||
1683|016|U|belongs to a class of drugs known as tyrosine kinase inhibitors.||
1683|017|U|It works by slowing or stopping the growth of cancer cells.||
1683|018|B|||
1683|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1683|020|H|from your pharmacist before you start taking lenvatinib and each||
1683|021|H|time you get a refill. If you have any questions, ask your doctor||
1683|022|H|or pharmacist.||
1683|023|H|   Take this medication by mouth with or without food as directed||
1683|024|H|by your doctor, usually once daily. Swallow the capsules whole.||
1683|025|H|Do not crush or chew the capsules. If you have trouble swallowing||
1683|026|H|the capsules whole, you may mix the capsules with water or apple||
1683|027|H|juice. The amount of liquid will depend on your dose. Consult||
1683|028|H|your doctor or pharmacist for more detailed instructions.||
1683|029|H|   If you are giving this medication through a feeding tube, ask||
1683|030|H|your health care professional for detailed instructions on how to||
1683|031|H|properly mix and give it.||
1683|032|H|   Lenvatinib may have different packaging and different dosage||
1683|033|H|instructions based on your medical condition. To prevent dosage||
1683|034|H|errors, ask your pharmacist about proper use. The dosage is also||
1683|035|H|based on your response to treatment and lab tests. For the||
1683|036|H|treatment of liver cancer, the dosage is also based on your||
1683|037|H|weight.||
1683|038|H|   Use this medication regularly to get the most benefit from it.||
1683|039|H|To help you remember, take it at the same time each day.||
1683|040|H|   Do not increase your dose or use this drug more often or for||
1683|041|H|longer than prescribed. Your condition will not improve any||
1683|042|H|faster, and your risk of serious side effects will increase.||
1683|043|H|   Since this drug can be absorbed through the skin and lungs and||
1683|044|H|may harm an unborn baby, women who are pregnant or who may become||
1683|045|H|pregnant should not handle this medication or breathe the dust||
1683|046|H|from the capsules.||
1683|047|B|||
1683|048|S|SIDE EFFECTS:  Dry mouth, hoarseness, nose bleeds, tiredness,||
1683|049|S|weight loss, headache, muscle/joint pain, trouble sleeping,||
1683|050|S|change in taste, diarrhea, constipation, upset stomach, nausea,||
1683|051|S|vomiting, or loss of appetite may occur. Nausea and vomiting can||
1683|052|S|be severe. In some cases, your doctor may prescribe medication to||
1683|053|S|prevent or relieve nausea and vomiting. Eating several small||
1683|054|S|meals, not eating before treatment, or limiting activity may help||
1683|055|S|lessen some of these effects. If any of these effects last or get||
1683|056|S|worse, tell your doctor or pharmacist promptly.||
1683|057|S|   Vomiting or diarrhea that doesn't stop may result in||
1683|058|S|dehydration. Contact your doctor promptly if you notice any||
1683|059|S|symptoms of dehydration, such as unusual dry mouth/thirst,||
1683|060|S|dizziness, or lightheadedness.||
1683|061|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
1683|062|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1683|063|S|substitute.||
1683|064|S|   Pain or sores in the mouth and throat may occur. Brush your||
1683|065|S|teeth carefully/gently, avoid using mouthwash that contains||
1683|066|S|alcohol, and rinse your mouth often with cool water mixed with||
1683|067|S|baking soda or salt. It may also be best to eat soft, moist||
1683|068|S|foods.||
1683|069|S|   Temporary hair loss may occur. Normal hair growth should||
1683|070|S|return after treatment has ended.||
1683|071|S|   People using this medication may have serious side effects.||
1683|072|S|However, you have been prescribed this drug because your doctor||
1683|073|S|has judged that the benefit to you is greater than the risk of||
1683|074|S|side effects. Careful monitoring by your doctor may decrease your||
1683|075|S|risk.||
1683|076|S|   This medication may raise your blood pressure. Check your||
1683|077|S|blood pressure regularly and tell your doctor if the results are||
1683|078|S|high. Your doctor may control your blood pressure with||
1683|079|S|medication.||
1683|080|S|   Lenvatinib may cause low blood calcium levels. Your doctor||
1683|081|S|will check lab tests during treatment, and may direct you to take||
1683|082|S|calcium and vitamin D.||
1683|083|S|   Tell your doctor right away if you have any serious side||
1683|084|S|effects, including: signs of new or worsening kidney problems||
1683|085|S|(such as change in the amount of urine, frothy urine), signs of||
1683|086|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1683|087|S|unusual tiredness, unusual/sudden weight gain), signs of an||
1683|088|S|underactive thyroid (such as weight gain, cold intolerance, slow||
1683|089|S|heartbeat), muscle spasms, redness/pain/swelling/blisters on the||
1683|090|S|palms of your hands or soles of your feet, easy||
1683|091|S|bleeding/bruising, slow wound healing.||
1683|092|S|   Get medical help right away if you have any very serious side||
1683|093|S|effects, including: symptoms of a heart attack (such as||
1683|094|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
1683|095|S|signs of a stroke (such as weakness on one side of the body,||
1683|096|S|trouble speaking, sudden vision changes, confusion), signs of||
1683|097|S|stomach/intestinal problems (such as bloody/black/tarry stools,||
1683|098|S|stomach/abdominal pain, bloody vomit, vomit that looks like||
1683|099|S|coffee grounds), sudden/severe back pain, fast/irregular||
1683|100|S|heartbeat, severe dizziness, fainting.||
1683|101|S|   Lenvatinib may rarely cause serious (possibly fatal) liver||
1683|102|S|disease. Get medical help right away if you have any symptoms of||
1683|103|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1683|104|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1683|105|S|urine.||
1683|106|S|   Lenvatinib may rarely cause a serious brain condition called||
1683|107|S|RPLS (reversible posterior leukoencephalopathy syndrome). Get||
1683|108|S|medical help right away if you have any symptoms of RPLS,||
1683|109|S|including: headaches that don't go away, seizures, sudden vision||
1683|110|S|changes, mental/mood changes (such as confusion).||
1683|111|S|   A very serious allergic reaction to this drug is rare.||
1683|112|S|However, get medical help right away if you notice any symptoms||
1683|113|S|of a serious allergic reaction, including: rash, itching/swelling||
1683|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1683|115|S|breathing.||
1683|116|S|   This is not a complete list of possible side effects. If you||
1683|117|S|notice other effects not listed above, contact your doctor or||
1683|118|S|pharmacist.||
1683|119|S|   In the US -||
1683|120|S|   Call your doctor for medical advice about side effects. You||
1683|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1683|122|S|www.fda.gov/medwatch.||
1683|123|S|   In Canada - Call your doctor for medical advice about side||
1683|124|S|effects. You may report side effects to Health Canada at||
1683|125|S|1-866-234-2345.||
1683|126|B|||
1683|127|P|PRECAUTIONS:  Before taking lenvatinib, tell your doctor or||
1683|128|P|pharmacist if you are allergic to it; or if you have any other||
1683|129|P|allergies. This product may contain inactive ingredients, which||
1683|130|P|can cause allergic reactions or other problems. Talk to your||
1683|131|P|pharmacist for more details.||
1683|132|P|   Before using this medication, tell your doctor or pharmacist||
1683|133|P|your medical history, especially of: liver disease, kidney||
1683|134|P|disease, high blood pressure, history of heart attack/stroke,||
1683|135|P|blood vessel problems (such as an aneurysm or a tear/break in the||
1683|136|P|aorta or other blood vessels), dehydration.||
1683|137|P|   Lenvatinib may cause a condition that affects the heart rhythm||
1683|138|P|(QT prolongation). QT prolongation can rarely cause serious||
1683|139|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1683|140|P|as severe dizziness, fainting) that need medical attention right||
1683|141|P|away.||
1683|142|P|   The risk of QT prolongation may be increased if you have||
1683|143|P|certain medical conditions or are taking other drugs that may||
1683|144|P|cause QT prolongation. Before using lenvatinib, tell your doctor||
1683|145|P|or pharmacist of all the drugs you take and if you have any of||
1683|146|P|the following conditions: certain heart problems (heart failure,||
1683|147|P|slow heartbeat, QT prolongation in the EKG), family history of||
1683|148|P|certain heart problems (QT prolongation in the EKG, sudden||
1683|149|P|cardiac death).||
1683|150|P|   Low levels of potassium or magnesium in the blood may also||
1683|151|P|increase your risk of QT prolongation. This risk may increase if||
1683|152|P|you use certain drugs (such as diuretics/"water pills") or if you||
1683|153|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1683|154|P|Talk to your doctor about using lenvatinib safely.||
1683|155|P|   Some people taking lenvatinib may have serious jawbone||
1683|156|P|problems. Your doctor should check your mouth before you start||
1683|157|P|this medication. Tell your dentist that you are taking this||
1683|158|P|medication before you have any dental work done. To help prevent||
1683|159|P|jawbone problems, have regular dental exams and learn how to keep||
1683|160|P|your teeth and gums healthy. If you have jaw pain, tell your||
1683|161|P|doctor and dentist right away.||
1683|162|P|   Before having surgery (especially dental procedures), tell||
1683|163|P|your doctor or dentist about this medication and all other||
1683|164|P|products you use (including prescription drugs, nonprescription||
1683|165|P|drugs, and herbal products).||
1683|166|P|   This medication may cause wounds to heal slowly or poorly.||
1683|167|P|Before having surgery, talk with your doctor about the risks and||
1683|168|P|benefits of this medication. Your doctor may tell you to||
1683|169|P|temporarily stop treatment with this medication at least 1 week||
1683|170|P|before surgery. Ask your doctor for specific instructions about||
1683|171|P|when to stop and when to restart treatment with lenvatinib. Tell||
1683|172|P|your doctor right away if you have wounds that are not healing||
1683|173|P|well.||
1683|174|P|   Older adults may be more sensitive to the side effects of this||
1683|175|P|drug, especially QT prolongation (see above).||
1683|176|P|   Since this drug can be absorbed through the skin and lungs and||
1683|177|P|may harm an unborn baby, women who are pregnant or who may become||
1683|178|P|pregnant should not handle this medication or breathe the dust||
1683|179|P|from the capsules.||
1683|180|P|   Tell your doctor if you are pregnant or plan to become||
1683|181|P|pregnant. You should not become pregnant while using lenvatinib.||
1683|182|P|Lenvatinib may harm an unborn baby. Your doctor should order a||
1683|183|P|pregnancy test before you start this medication. Ask about||
1683|184|P|reliable forms of birth control while using this medication and||
1683|185|P|for at least 30 days after the last dose. If you become pregnant,||
1683|186|P|talk to your doctor right away about the risks and benefits of||
1683|187|P|this medication.||
1683|188|P|   It is unknown if this drug passes into breast milk. Because of||
1683|189|P|the possible risk to the infant, breastfeeding is not recommended||
1683|190|P|while using this drug and for at least 1 week after the last||
1683|191|P|dose. Consult your doctor before breastfeeding.||
1683|192|B|||
1683|193|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1683|194|I|medications work or increase your risk for serious side effects.||
1683|195|I|This document does not contain all possible drug interactions.||
1683|196|I|Keep a list of all the products you use (including||
1683|197|I|prescription/nonprescription drugs and herbal products) and share||
1683|198|I|it with your doctor and pharmacist. Do not start, stop, or change||
1683|199|I|the dosage of any medicines without your doctor's approval.||
1683|200|B|||
1683|201|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1683|202|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1683|203|O|poison control center right away. US residents can call||
1683|204|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1683|205|B|||
1683|206|N|NOTES:  Do not share this medication with others.||
1683|207|N|   Lab and/or medical tests (such as blood pressure, EKG, urine||
1683|208|N|protein, kidney/liver/thyroid function, mineral levels in the||
1683|209|N|blood) should be done before and while you are taking this||
1683|210|N|medication. Keep all medical and lab appointments.||
1683|211|B|||
1683|212|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1683|213|D|remember. If it is less than 12 hours before the next dose, skip||
1683|214|D|the missed dose. Take your next dose at the regular time. Do not||
1683|215|D|double the dose to catch up.||
1683|216|B|||
1683|217|R|STORAGE:  Store at room temperature away from light and moisture.||
1683|218|R|Do not store in the bathroom. Keep all medications away from||
1683|219|R|children and pets.||
1683|220|R|   Do not flush medications down the toilet or pour them into a||
1683|221|R|drain unless instructed to do so. Properly discard this product||
1683|222|R|when it is expired or no longer needed. Consult your pharmacist||
1683|223|R|or local waste disposal company.||
1683|224|B|||
1683|225|A|Information last revised May 2024.||
1683|226|A|Copyright(c) 2025 First Databank, Inc.||
1683|227|B|||
1684|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1684|002|Z|does NOT have all possible information about this product. This||
1684|003|Z|information does not assure that this product is safe, effective,||
1684|004|Z|or appropriate for you. This information is not individual||
1684|005|Z|medical advice and does not substitute for the advice of your||
1684|006|Z|health care professional. Always ask your health care||
1684|007|Z|professional for complete information about this product and your||
1684|008|Z|specific health needs.||
1684|009|B|||
1684|010|T|MIGLUSTAT - ORAL||
1684|011|F|(mi-GLOO-stat)||
1684|012|B|||
1684|013|C|COMMON BRAND NAME(S): Zavesca||
1684|014|B|||
1684|015|U|USES:  Miglustat is used for the long-term treatment of a certain||
1684|016|U|rare genetic problem (Gaucher's disease). It works by decreasing||
1684|017|U|the amount of a certain natural fatty substance||
1684|018|U|(glucosylceramide) that builds up due to this condition. This can||
1684|019|U|help improve symptoms of Gaucher's disease, such as tiredness,||
1684|020|U|pain in the joints/bones, and a swollen liver or spleen.||
1684|021|B|||
1684|022|V|OTHER USES:  This section contains uses of this drug that are not||
1684|023|V|listed in the approved professional labeling for the drug but||
1684|024|V|that may be prescribed by your health care professional. Use this||
1684|025|V|drug for a condition that is listed in this section only if it||
1684|026|V|has been so prescribed by your health care professional.||
1684|027|V|   Miglustat is also available in another strength and other||
1684|028|V|brands for a certain inherited condition (Pompe disease). Do not||
1684|029|V|take this medication with any other product that contains||
1684|030|V|miglustat.||
1684|031|B|||
1684|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1684|033|H|from your pharmacist before you start taking miglustat and each||
1684|034|H|time you get a refill. If you have any questions, ask your doctor||
1684|035|H|or pharmacist.||
1684|036|H|   Take this medication by mouth with or without food as directed||
1684|037|H|by your doctor, usually 3 times a day. The dosage is based on||
1684|038|H|your medical condition and response to treatment.||
1684|039|H|   Take this medication regularly to get the most benefit from||
1684|040|H|it. To help you remember, take it at the same times each day.||
1684|041|H|   Tell your doctor if your condition does not get better or if||
1684|042|H|it gets worse.||
1684|043|B|||
1684|044|S|SIDE EFFECTS:  Nausea, vomiting, stomach/abdominal pain, gas,||
1684|045|S|diarrhea, weight loss, headache, muscle cramps, dizziness, or||
1684|046|S|weakness may occur. If any of these effects last or get worse,||
1684|047|S|tell your doctor or pharmacist promptly.||
1684|048|S|   To reduce diarrhea, your doctor may tell you to take miglustat||
1684|049|S|between meals, recommend that you change your diet to avoid||
1684|050|S|high-carbohydrate foods, or prescribe a drug (such as loperamide)||
1684|051|S|to treat diarrhea. Talk to your doctor or pharmacist for more||
1684|052|S|details.||
1684|053|S|   Remember that this medication has been prescribed because your||
1684|054|S|doctor has judged that the benefit to you is greater than the||
1684|055|S|risk of side effects. Many people using this medication do not||
1684|056|S|have serious side effects.||
1684|057|S|   Tell your doctor right away if you have any serious side||
1684|058|S|effects, including: numbness/tingling/weakness/pain of the hands||
1684|059|S|or feet, new/worsening shaking or tremor of the hands, vision||
1684|060|S|changes, new/worsening bruising/bleeding.||
1684|061|S|   A very serious allergic reaction to this drug is rare.||
1684|062|S|However, get medical help right away if you notice any symptoms||
1684|063|S|of a serious allergic reaction, including: rash, itching/swelling||
1684|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1684|065|S|breathing.||
1684|066|S|   This is not a complete list of possible side effects. If you||
1684|067|S|notice other effects not listed above, contact your doctor or||
1684|068|S|pharmacist.||
1684|069|S|   In the US -||
1684|070|S|   Call your doctor for medical advice about side effects. You||
1684|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1684|072|S|www.fda.gov/medwatch.||
1684|073|S|   In Canada - Call your doctor for medical advice about side||
1684|074|S|effects. You may report side effects to Health Canada at||
1684|075|S|1-866-234-2345.||
1684|076|B|||
1684|077|P|PRECAUTIONS:  Before taking miglustat, tell your doctor or||
1684|078|P|pharmacist if you are allergic to it; or if you have any other||
1684|079|P|allergies. This product may contain inactive ingredients, which||
1684|080|P|can cause allergic reactions or other problems. Talk to your||
1684|081|P|pharmacist for more details.||
1684|082|P|   Before using this medication, tell your doctor or pharmacist||
1684|083|P|your medical history, especially of: kidney disease,||
1684|084|P|numbness/tingling of the hands/feet, stomach/intestinal problems||
1684|085|P|(such as inflammatory bowel disease).||
1684|086|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1684|087|P|can make you more dizzy. Do not drive, use machinery, or do||
1684|088|P|anything that needs alertness until you can do it safely. Limit||
1684|089|P|alcoholic beverages. Talk to your doctor if you are using||
1684|090|P|marijuana (cannabis).||
1684|091|P|   Before having surgery, tell your doctor or dentist about all||
1684|092|P|the products you use (including prescription drugs,||
1684|093|P|nonprescription drugs, and herbal products).||
1684|094|P|   During pregnancy, this medication should be used only when||
1684|095|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1684|096|P|benefits with your doctor.||
1684|097|P|   It is unknown if this medication passes into breast milk.||
1684|098|P|Because of the possible risk to the infant, breastfeeding is not||
1684|099|P|recommended while using this medication. Consult your doctor||
1684|100|P|before breastfeeding.||
1684|101|B|||
1684|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1684|103|I|medications work or increase your risk for serious side effects.||
1684|104|I|This document does not contain all possible drug interactions.||
1684|105|I|Keep a list of all the products you use (including||
1684|106|I|prescription/nonprescription drugs and herbal products) and share||
1684|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1684|108|I|the dosage of any medicines without your doctor's approval.||
1684|109|B|||
1684|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1684|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1684|112|O|poison control center right away. US residents can call||
1684|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1684|114|B|||
1684|115|N|NOTES:  Do not share this medication with others.||
1684|116|N|   Lab and/or medical tests (such as nerve function, kidney||
1684|117|N|function, liver/spleen measurements, complete blood count||
1684|118|N|including platelets) should be done while you are taking this||
1684|119|N|medication. Keep all medical and lab appointments. Consult your||
1684|120|N|doctor for more details.||
1684|121|B|||
1684|122|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1684|123|D|next dose at the regular time. Do not double the dose to catch||
1684|124|D|up.||
1684|125|B|||
1684|126|R|STORAGE:  Store at room temperature away from light and moisture.||
1684|127|R|Do not store in the bathroom. Keep all medications away from||
1684|128|R|children and pets.||
1684|129|R|   Do not flush medications down the toilet or pour them into a||
1684|130|R|drain unless instructed to do so. Properly discard this product||
1684|131|R|when it is expired or no longer needed. Consult your pharmacist||
1684|132|R|or local waste disposal company.||
1684|133|B|||
1684|134|A|Information last revised October 2024.||
1684|135|A|Copyright(c) 2025 First Databank, Inc.||
1684|136|B|||
1685|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1685|002|Z|does NOT have all possible information about this product. This||
1685|003|Z|information does not assure that this product is safe, effective,||
1685|004|Z|or appropriate for you. This information is not individual||
1685|005|Z|medical advice and does not substitute for the advice of your||
1685|006|Z|health care professional. Always ask your health care||
1685|007|Z|professional for complete information about this product and your||
1685|008|Z|specific health needs.||
1685|009|B|||
1685|010|T|PASIREOTIDE - INTRAMUSCULAR INJECTION||
1685|011|F|(PAS-i-REE-oh-tide)||
1685|012|B|||
1685|013|C|COMMON BRAND NAME(S): Signifor Lar||
1685|014|B|||
1685|015|U|USES:  Pasireotide is used to treat a certain condition||
1685|016|U|(acromegaly) that occurs when the body makes too much of a||
1685|017|U|certain natural substance called growth hormone. Treating||
1685|018|U|acromegaly helps reduce the risk of serious problems such as||
1685|019|U|diabetes and heart disease. Pasireotide works by decreasing the||
1685|020|U|amount of growth hormone made in the body.||
1685|021|U|   Pasireotide is also used to treat a certain condition||
1685|022|U|(Cushing's disease) when surgery has not been fully successful or||
1685|023|U|cannot be used to correct the condition. Cushing's disease occurs||
1685|024|U|when the body makes too much of a certain hormone called||
1685|025|U|cortisol. Having too much cortisol in the body may lead to high||
1685|026|U|blood pressure, high blood sugar, and other problems. Pasireotide||
1685|027|U|works by decreasing the amount of cortisol made in the body.||
1685|028|B|||
1685|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1685|030|H|from your pharmacist before you start using pasireotide and||
1685|031|H|before each injection. If you have any questions, ask your doctor||
1685|032|H|or pharmacist.||
1685|033|H|   This medication is given by injection into a muscle in the||
1685|034|H|buttocks by a health care professional. It is given as directed||
1685|035|H|by your doctor, usually once every 4 weeks (28 days).||
1685|036|H|   The dosage is based on your medical condition, lab tests, and||
1685|037|H|response to treatment.||
1685|038|H|   Use this medication regularly to get the most benefit from it.||
1685|039|H|To help you remember, mark your calendar with a reminder.||
1685|040|H|   Tell your doctor if your condition does not get better or if||
1685|041|H|it gets worse.||
1685|042|B|||
1685|043|S|SIDE EFFECTS:  Dizziness, headache, hair loss, muscle pain, gas,||
1685|044|S|bloating, or diarrhea may occur. Pain, swelling, itchiness,||
1685|045|S|redness, or irritation at the injection site may also occur. If||
1685|046|S|any of these effects last or get worse, tell your doctor or||
1685|047|S|pharmacist promptly.||
1685|048|S|   Remember that this medication has been prescribed because your||
1685|049|S|doctor has judged that the benefit to you is greater than the||
1685|050|S|risk of side effects. Many people using this medication do not||
1685|051|S|have serious side effects.||
1685|052|S|   This medication may cause changes in blood sugar, especially||
1685|053|S|if you have diabetes. Symptoms of high blood sugar include||
1685|054|S|increased thirst and urination. Symptoms of low blood sugar||
1685|055|S|include sudden sweating, shaking, fast heartbeat, hunger, blurred||
1685|056|S|vision, dizziness, or tingling hands/feet. Follow your doctor's||
1685|057|S|instructions to treat low blood sugar (for example, by eating a||
1685|058|S|quick source of sugar such as glucose gel/tablets, table sugar,||
1685|059|S|honey, or drinking fruit juice or non-diet soda). Tell your||
1685|060|S|doctor right away if you experience symptoms of high or low blood||
1685|061|S|sugar while using this medication. Monitor your blood sugar||
1685|062|S|levels as directed by your doctor. Your doctor may need to adjust||
1685|063|S|your diabetes medications.||
1685|064|S|   Tell your doctor right away if you have any serious side||
1685|065|S|effects, including: slow heartbeat, unusual tiredness,||
1685|066|S|nausea/vomiting, weight loss, change in stool color, signs of||
1685|067|S|liver/gall bladder disease (such as loss of appetite,||
1685|068|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1685|069|S|   Get medical help right away if you have any very serious side||
1685|070|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1685|071|S|fainting.||
1685|072|S|   A very serious allergic reaction to this drug is rare.||
1685|073|S|However, get medical help right away if you notice any symptoms||
1685|074|S|of a serious allergic reaction, including: rash, itching/swelling||
1685|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1685|076|S|breathing.||
1685|077|S|   This is not a complete list of possible side effects. If you||
1685|078|S|notice other effects not listed above, contact your doctor or||
1685|079|S|pharmacist.||
1685|080|S|   In the US -||
1685|081|S|   Call your doctor for medical advice about side effects. You||
1685|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1685|083|S|www.fda.gov/medwatch.||
1685|084|S|   In Canada - Call your doctor for medical advice about side||
1685|085|S|effects. You may report side effects to Health Canada at||
1685|086|S|1-866-234-2345.||
1685|087|B|||
1685|088|P|PRECAUTIONS:  Before using pasireotide, tell your doctor or||
1685|089|P|pharmacist if you are allergic to it; or if you have any other||
1685|090|P|allergies. This product may contain inactive ingredients, which||
1685|091|P|can cause allergic reactions or other problems. Talk to your||
1685|092|P|pharmacist for more details.||
1685|093|P|   Before using this medication, tell your doctor or pharmacist||
1685|094|P|your medical history, especially of: liver disease, diabetes,||
1685|095|P|heart block, gall bladder disease (such as gallstones).||
1685|096|P|   Pasireotide may cause a condition that affects the heart||
1685|097|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1685|098|P|serious (rarely fatal) fast/irregular heartbeat and other||
1685|099|P|symptoms (such as severe dizziness, fainting) that need medical||
1685|100|P|attention right away.||
1685|101|P|   The risk of QT prolongation may be increased if you have||
1685|102|P|certain medical conditions or are taking other drugs that may||
1685|103|P|cause QT prolongation. Before using pasireotide, tell your doctor||
1685|104|P|or pharmacist of all the drugs you take and if you have any of||
1685|105|P|the following conditions: certain heart problems (heart failure,||
1685|106|P|slow heartbeat, QT prolongation in the EKG), family history of||
1685|107|P|certain heart problems (QT prolongation in the EKG, sudden||
1685|108|P|cardiac death).||
1685|109|P|   Low levels of potassium or magnesium in the blood may also||
1685|110|P|increase your risk of QT prolongation. This risk may increase if||
1685|111|P|you use certain drugs (such as diuretics/"water pills") or if you||
1685|112|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1685|113|P|Talk to your doctor about using pasireotide safely.||
1685|114|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1685|115|P|can make you more dizzy. Do not drive, use machinery, or do||
1685|116|P|anything that needs alertness until you can do it safely. Limit||
1685|117|P|alcoholic beverages. Talk to your doctor if you are using||
1685|118|P|marijuana (cannabis).||
1685|119|P|   Before having surgery, tell your doctor or dentist about all||
1685|120|P|the products you use (including prescription drugs,||
1685|121|P|nonprescription drugs, and herbal products).||
1685|122|P|   Older adults may be more sensitive to the side effects of this||
1685|123|P|drug, especially QT prolongation (see above).||
1685|124|P|   Treatment with this medication may improve fertility in women||
1685|125|P|and may lead to unintended pregnancy. Ask your doctor for more||
1685|126|P|details.||
1685|127|P|   During pregnancy, this medication should be used only when||
1685|128|P|clearly needed. Discuss the risks and benefits with your doctor.||
1685|129|P|   It is unknown if this medication passes into breast milk.||
1685|130|P|Consult your doctor before breastfeeding.||
1685|131|B|||
1685|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1685|133|I|medications work or increase your risk for serious side effects.||
1685|134|I|This document does not contain all possible drug interactions.||
1685|135|I|Keep a list of all the products you use (including||
1685|136|I|prescription/nonprescription drugs and herbal products) and share||
1685|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
1685|138|I|the dosage of any medicines without your doctor's approval.||
1685|139|B|||
1685|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1685|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1685|142|O|poison control center right away. US residents can call||
1685|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1685|144|B|||
1685|145|N|NOTES:  Do not share this medication with others.||
1685|146|N|   Lab and/or medical tests (such as growth hormone levels, EKG,||
1685|147|N|blood sugar tests, hemoglobin A1c, liver function, mineral levels||
1685|148|N|in the blood, hormonal levels including cortisol and thyroid)||
1685|149|N|should be done before you start using this medication and while||
1685|150|N|you are using it. Keep all medical and lab appointments. Consult||
1685|151|N|your doctor for more details.||
1685|152|B|||
1685|153|D|MISSED DOSE:  It is important to get each dose of this medication||
1685|154|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1685|155|D|right away for a new dosing schedule. Do not double the dose to||
1685|156|D|catch up.||
1685|157|B|||
1685|158|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
1685|159|R|medications away from children and pets.||
1685|160|R|   Do not flush medications down the toilet or pour them into a||
1685|161|R|drain unless instructed to do so. Properly discard this product||
1685|162|R|when it is expired or no longer needed. Consult your pharmacist||
1685|163|R|or local waste disposal company.||
1685|164|B|||
1685|165|A|Information last revised October 2024.||
1685|166|A|Copyright(c) 2025 First Databank, Inc.||
1685|167|B|||
1686|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1686|002|Z|does NOT have all possible information about this product. This||
1686|003|Z|information does not assure that this product is safe, effective,||
1686|004|Z|or appropriate for you. This information is not individual||
1686|005|Z|medical advice and does not substitute for the advice of your||
1686|006|Z|health care professional. Always ask your health care||
1686|007|Z|professional for complete information about this product and your||
1686|008|Z|specific health needs.||
1686|009|B|||
1686|010|T|INSULIN GLARGINE 300 UNITS/ML PEN - INJECTION||
1686|011|F|(IN-su-lin GLAR-jeen)||
1686|012|B|||
1686|013|C|COMMON BRAND NAME(S): Toujeo||
1686|014|B|||
1686|015|U|USES:  Insulin glargine is used with a proper diet and exercise||
1686|016|U|program to control high blood sugar in people with diabetes.||
1686|017|U|Controlling high blood sugar helps prevent kidney damage,||
1686|018|U|blindness, nerve problems, loss of limbs, and sexual function||
1686|019|U|problems. Proper control of diabetes may also lessen your risk of||
1686|020|U|a heart attack or stroke.||
1686|021|U|   Insulin glargine is a man-made product that is similar to||
1686|022|U|human insulin. It replaces the insulin that your body would||
1686|023|U|normally make. It acts longer than regular insulin, providing a||
1686|024|U|low, steady level of insulin. It works by helping blood sugar||
1686|025|U|(glucose) get into cells so your body can use it for energy.||
1686|026|U|Insulin glargine may be used with a shorter-acting insulin||
1686|027|U|product. It may also be used alone or with other diabetes drugs.||
1686|028|B|||
1686|029|H|HOW TO USE:  Read the Patient Information Leaflet and||
1686|030|H|Instructions for Use if available from your pharmacist before you||
1686|031|H|start using this medication and each time you get a refill. Ask||
1686|032|H|your health care professional how to prepare and use this||
1686|033|H|medication. If you have any questions, ask your doctor or||
1686|034|H|pharmacist.||
1686|035|H|   This insulin product is a concentrated form of standard||
1686|036|H|insulin (3 times as much insulin in each milliliter). Check that||
1686|037|H|you are using the correct insulin before injecting this||
1686|038|H|medication.||
1686|039|H|   Inject this medication under the skin as directed by your||
1686|040|H|doctor, usually once daily. The injection is given in the stomach||
1686|041|H|area, the thigh, or the upper arm. Do not inject into a vein or||
1686|042|H|muscle because very low blood sugar (hypoglycemia) may occur.||
1686|043|H|   The dosage is based on your medical condition and response to||
1686|044|H|treatment. Measure each dose very carefully because even small||
1686|045|H|changes in the amount of insulin may have a large effect on your||
1686|046|H|blood sugar.||
1686|047|H|   Before using, check this product for particles or||
1686|048|H|discoloration. If either is present, do not use the insulin.||
1686|049|H|Before injecting each dose, clean the skin you are going to||
1686|050|H|inject into (the injection site) with rubbing alcohol. Change the||
1686|051|H|injection site each time to lessen injury under the skin (for||
1686|052|H|example, pits/lumps or thickened skin). Do not inject into skin||
1686|053|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
1686|054|H|not rub the injection site after a shot. Do not inject cold||
1686|055|H|insulin because this can be painful. The pen device you are||
1686|056|H|currently using can be kept at room temperature. Learn how to||
1686|057|H|store and discard medical supplies safely.||
1686|058|H|   This product should not be mixed with any other insulin. Do||
1686|059|H|not use insulin glargine in an infusion pump.||
1686|060|H|   Do not change brands or types of insulin without directions on||
1686|061|H|how to do so from your doctor.||
1686|062|H|   Do not share your pen device with another person, even if the||
1686|063|H|needle is changed. You may give other people a serious infection,||
1686|064|H|or get a serious infection from them.||
1686|065|H|   Use this medication regularly to get the most benefit from it.||
1686|066|H|To help you remember, use it at the same time each day.||
1686|067|H|   Tell your doctor if your condition does not get better or if||
1686|068|H|it gets worse (your blood sugar is too high or too low).||
1686|069|B|||
1686|070|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
1686|071|S|irritation) or weight gain may occur. If any of these effects||
1686|072|S|last or get worse, tell your doctor or pharmacist promptly.||
1686|073|S|   Remember that this medication has been prescribed because your||
1686|074|S|doctor has judged that the benefit to you is greater than the||
1686|075|S|risk of side effects. Many people using this medication do not||
1686|076|S|have serious side effects.||
1686|077|S|   Tell your doctor right away if you have any serious side||
1686|078|S|effects, including: signs of low potassium level in the blood||
1686|079|S|(such as muscle cramps, weakness, irregular heartbeat).||
1686|080|S|   This medication can cause low blood sugar (hypoglycemia). This||
1686|081|S|may occur if you do not get enough calories from food or if you||
1686|082|S|do unusually heavy exercise. Symptoms of low blood sugar include||
1686|083|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
1686|084|S|dizziness, or tingling hands/feet. It is a good habit to carry||
1686|085|S|glucose tablets or gel to treat low blood sugar. If you don't||
1686|086|S|have these reliable forms of glucose, rapidly raise your blood||
1686|087|S|sugar by eating a quick source of sugar such as table sugar,||
1686|088|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
1686|089|S|doctor right away about the reaction and the use of this product.||
1686|090|S|To help prevent low blood sugar, eat meals on a regular schedule,||
1686|091|S|and do not skip meals. Check with your doctor or pharmacist to||
1686|092|S|find out what you should do if you miss a meal.||
1686|093|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1686|094|S|thirst/urination. If these symptoms occur, tell your doctor right||
1686|095|S|away. Your doctor may need to adjust your diabetes medication,||
1686|096|S|exercise program, or diet.||
1686|097|S|   A very serious allergic reaction to this drug is rare.||
1686|098|S|However, get medical help right away if you notice any symptoms||
1686|099|S|of a serious allergic reaction, including: rash, itching/swelling||
1686|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1686|101|S|breathing.||
1686|102|S|   This is not a complete list of possible side effects. If you||
1686|103|S|notice other effects not listed above, contact your doctor or||
1686|104|S|pharmacist.||
1686|105|S|   In the US -||
1686|106|S|   Call your doctor for medical advice about side effects. You||
1686|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1686|108|S|www.fda.gov/medwatch.||
1686|109|S|   In Canada - Call your doctor for medical advice about side||
1686|110|S|effects. You may report side effects to Health Canada at||
1686|111|S|1-866-234-2345.||
1686|112|B|||
1686|113|P|PRECAUTIONS:  Before using insulin glargine, tell your doctor or||
1686|114|P|pharmacist if you are allergic to it; or to other types of||
1686|115|P|insulins; or if you have any other allergies. This product may||
1686|116|P|contain inactive ingredients, which can cause allergic reactions||
1686|117|P|or other problems. Talk to your pharmacist for more details.||
1686|118|P|   Do not use this medication when you have low blood sugar||
1686|119|P|(hypoglycemia).||
1686|120|P|   Before using this medication, tell your doctor or pharmacist||
1686|121|P|your medical history, especially of: kidney disease, liver||
1686|122|P|disease.||
1686|123|P|   You may experience blurred vision, dizziness, or drowsiness||
1686|124|P|due to extremely low or high blood sugar. Do not drive, use||
1686|125|P|machinery, or do anything that needs alertness or clear vision||
1686|126|P|until you can do it safely.||
1686|127|P|   Limit alcohol while using this medication because it can||
1686|128|P|increase the risk of developing low blood sugar.||
1686|129|P|   It may be harder to control your blood sugar when your body is||
1686|130|P|stressed (such as due to fever, infection, injury, or surgery).||
1686|131|P|Consult your doctor because this may require a change in your||
1686|132|P|treatment plan, medications, or blood sugar testing.||
1686|133|P|   Before having surgery, tell your doctor or dentist about all||
1686|134|P|the products you use (including prescription drugs,||
1686|135|P|nonprescription drugs, and herbal products).||
1686|136|P|   Check your blood sugar before and after exercise. You may need||
1686|137|P|a snack before exercising.||
1686|138|P|   If traveling across time zones, ask your doctor about how to||
1686|139|P|adjust your insulin schedule. Take extra insulin and supplies||
1686|140|P|with you.||
1686|141|P|   Older adults may be more sensitive to the side effects of this||
1686|142|P|drug, especially low blood sugar.||
1686|143|P|   Children may be more sensitive to the side effects of this||
1686|144|P|drug, especially low blood sugar.||
1686|145|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
1686|146|P|cause or worsen diabetes. Discuss a plan with your doctor for||
1686|147|P|managing your blood sugar while pregnant. Your doctor may change||
1686|148|P|your diabetes treatment during your pregnancy (such as diet and||
1686|149|P|medications including insulin).||
1686|150|P|   This medication passes into breast milk, but is unlikely to||
1686|151|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1686|152|P|Your insulin needs may change while breastfeeding.||
1686|153|B|||
1686|154|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1686|155|I|medications work or increase your risk for serious side effects.||
1686|156|I|This document does not contain all possible drug interactions.||
1686|157|I|Keep a list of all the products you use (including||
1686|158|I|prescription/nonprescription drugs and herbal products) and share||
1686|159|I|it with your doctor and pharmacist. Do not start, stop, or change||
1686|160|I|the dosage of any medicines without your doctor's approval.||
1686|161|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1686|162|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1686|163|I|heartbeat you would usually feel when your blood sugar falls too||
1686|164|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
1686|165|I|dizziness, hunger, or sweating are unaffected by these drugs.||
1686|166|I|   Many drugs can affect your blood sugar levels, making it more||
1686|167|I|difficult to control your blood sugar. Before you start, stop, or||
1686|168|I|change any medication, talk with your doctor or pharmacist about||
1686|169|I|how the medication may affect your blood sugar. Check your blood||
1686|170|I|sugar regularly as directed by your doctor. Tell your doctor||
1686|171|I|about the results and of any symptoms of high or low blood sugar.||
1686|172|I|(See also Side Effects section.) Your doctor may need to adjust||
1686|173|I|your diabetes medication, exercise program, or diet.||
1686|174|B|||
1686|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1686|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1686|177|O|poison control center right away. US residents can call||
1686|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1686|179|O|Symptoms of overdose may include: signs of low blood sugar such||
1686|180|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
1686|181|B|||
1686|182|N|NOTES:  Do not share this medication or needles with others.||
1686|183|N|   Attend a diabetes education program to learn more about how to||
1686|184|N|manage your diabetes with medications, diet, exercise, and||
1686|185|N|regular medical exams.||
1686|186|N|   Learn the symptoms of high and low blood sugar and how to||
1686|187|N|treat low blood sugar. Check your blood sugar regularly as||
1686|188|N|directed and share the results with your doctor.||
1686|189|N|   Lab and/or medical tests (such as liver/kidney function,||
1686|190|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
1686|191|N|should be done while you are taking this medication. Keep all||
1686|192|N|medical and lab appointments.||
1686|193|N|   Keep extra supplies of insulin and needles on hand.||
1686|194|B|||
1686|195|D|MISSED DOSE:  It is very important to follow your insulin regimen||
1686|196|D|exactly. Ask your doctor ahead of time what you should do if you||
1686|197|D|miss a dose of insulin.||
1686|198|B|||
1686|199|R|STORAGE:  Store the unopened insulin pen in the refrigerator. Do||
1686|200|R|not freeze, and do not use insulin that has been frozen. After||
1686|201|R|opening, store the insulin glargine pen at room temperature.||
1686|202|R|Throw away the insulin glargine pen in use after the time||
1686|203|R|specified in your product's Instructions for Use, even if there||
1686|204|R|is insulin left. Different brands of this medication have||
1686|205|R|different storage needs. Also throw away all insulin products||
1686|206|R|after the expiration date on the package. Protect insulin from||
1686|207|R|light and heat. Do not store in the bathroom. Keep all||
1686|208|R|medications away from children and pets.||
1686|209|R|   Do not flush medications down the toilet or pour them into a||
1686|210|R|drain unless instructed to do so. Properly discard this product||
1686|211|R|when it is expired or no longer needed. Consult your pharmacist||
1686|212|R|or local waste disposal company.||
1686|213|B|||
1686|214|M|MEDICAL ALERT:  Your condition can cause complications in a||
1686|215|M|medical emergency. For information about enrolling in MedicAlert,||
1686|216|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1686|217|B|||
1686|218|A|Information last revised April 2025.||
1686|219|A|Copyright(c) 2025 First Databank, Inc.||
1686|220|B|||
1687|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1687|002|Z|does NOT have all possible information about this product. This||
1687|003|Z|information does not assure that this product is safe, effective,||
1687|004|Z|or appropriate for you. This information is not individual||
1687|005|Z|medical advice and does not substitute for the advice of your||
1687|006|Z|health care professional. Always ask your health care||
1687|007|Z|professional for complete information about this product and your||
1687|008|Z|specific health needs.||
1687|009|B|||
1687|010|T|PANOBINOSTAT - ORAL||
1687|011|F|(PAN-oh-BIN-oh-stat)||
1687|012|B|||
1687|013|C|COMMON BRAND NAME(S): Farydak||
1687|014|B|||
1687|015|W|WARNING:  Panobinostat can cause diarrhea which may become very||
1687|016|W|severe. Tell your doctor right away if you get diarrhea or have||
1687|017|W|abdominal/stomach pain or cramping. Your doctor may need to||
1687|018|W|prescribe medication to stop the diarrhea or stop panobinostat||
1687|019|W|until your diarrhea gets better. Talk to your doctor for more||
1687|020|W|details.||
1687|021|W|   Panobinostat can cause very serious (possibly fatal) heart||
1687|022|W|problems (such as heart attack, irregular heartbeat). Your risk||
1687|023|W|of irregular heartbeat may be increased due to high or low blood||
1687|024|W|mineral levels. Your doctor will monitor your medical and lab||
1687|025|W|tests very closely while you are taking this medication. Get||
1687|026|W|medical help right away if you have any signs of heart problems,||
1687|027|W|including: chest/jaw/left arm pain, fast/slow/irregular||
1687|028|W|heartbeat, severe dizziness, fainting (see also Precautions||
1687|029|W|section).||
1687|030|B|||
1687|031|U|USES:  Panobinostat is used to treat multiple myeloma. It works||
1687|032|U|by slowing or stopping the growth of cancer cells.||
1687|033|U|   This drug has been withdrawn from the US market due to||
1687|034|U|problems with effectiveness.||
1687|035|B|||
1687|036|H|HOW TO USE:  Read the Medication Guide provided by your||
1687|037|H|pharmacist before you start taking panobinostat and each time you||
1687|038|H|get a refill. If you have any questions, ask your doctor or||
1687|039|H|pharmacist.||
1687|040|H|   Take this medication by mouth with or without food as directed||
1687|041|H|by your doctor. It is usually taken once every other day for 3||
1687|042|H|doses each week for the first 2 weeks, then stopped for 1 week.||
1687|043|H|This is one cycle of treatment. Keep taking the medication this||
1687|044|H|way as directed by your doctor. Swallow the capsules whole with a||
1687|045|H|cup of water. Do not crush, chew, or open the capsules. If you||
1687|046|H|vomit after taking the medication, do not take another dose of||
1687|047|H|the medication that day. Take the next dose at the usual time.||
1687|048|H|   Avoid getting the powder in the capsule onto your skin or into||
1687|049|H|your eyes. If the powder does get onto the skin, wash the area||
1687|050|H|with water and soap. If the powder gets into the eyes, flush the||
1687|051|H|eyes with plenty of water.||
1687|052|H|   The dosage is based on your medical condition, lab tests,||
1687|053|H|response to treatment, and other medications you may be taking.||
1687|054|H|Be sure to tell your doctor and pharmacist about all the products||
1687|055|H|you use (including prescription drugs, nonprescription drugs, and||
1687|056|H|herbal products). Your doctor may stop your medication for a||
1687|057|H|while if you get any side effects. Talk to your doctor for more||
1687|058|H|details.||
1687|059|H|   Avoid eating grapefruit, star fruit, or pomegranate or||
1687|060|H|drinking grapefruit or pomegranate juice while using this||
1687|061|H|medication unless your doctor or pharmacist says you may do so||
1687|062|H|safely. These fruits can increase the chance of side effects with||
1687|063|H|this medicine. Ask your doctor or pharmacist for more details.||
1687|064|H|   Use this medication regularly to get the most benefit from it.||
1687|065|H|To help you remember, take it at the same time on the days you||
1687|066|H|are scheduled to take the medication. Mark your calendar with a||
1687|067|H|reminder.||
1687|068|H|   Do not increase your dose or use this drug more often or for||
1687|069|H|longer than prescribed. Your condition will not improve any||
1687|070|H|faster, and your risk of serious side effects will increase.||
1687|071|H|   Since this drug can be absorbed through the skin and lungs and||
1687|072|H|may harm an unborn baby, women who are pregnant or who may become||
1687|073|H|pregnant should not handle this medication or breathe the powder||
1687|074|H|from the capsules.||
1687|075|B|||
1687|076|S|SIDE EFFECTS:  See also Warning section.||
1687|077|S|   Nausea, vomiting, tiredness, loss of appetite, diarrhea,||
1687|078|S|weight loss, swelling hands/ankles/feet, or weakness may occur.||
1687|079|S|Nausea and vomiting can be severe. In some cases, your doctor may||
1687|080|S|prescribe medication to prevent or relieve nausea and vomiting.||
1687|081|S|Eating several small meals or limiting activity may help lessen||
1687|082|S|some of these effects. If any of these effects last or get worse,||
1687|083|S|tell your doctor or pharmacist promptly.||
1687|084|S|   People using this medication may have serious side effects.||
1687|085|S|However, you have been prescribed this drug because your doctor||
1687|086|S|has judged that the benefit to you is greater than the risk of||
1687|087|S|side effects. Careful monitoring by your doctor may decrease your||
1687|088|S|risk.||
1687|089|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
1687|090|S|Contact your doctor promptly if you notice any symptoms of||
1687|091|S|dehydration, such as unusual decreased urination, unusual dry||
1687|092|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness.||
1687|093|S|   Panobinostat may rarely cause serious liver disease. Tell your||
1687|094|S|doctor right away if you have any symptoms of liver damage,||
1687|095|S|including: nausea/vomiting that doesn't stop, yellowing||
1687|096|S|eyes/skin, dark urine.||
1687|097|S|   This medication decreases bone marrow function, an effect that||
1687|098|S|may lead to a low number of blood cells such as red cells, white||
1687|099|S|cells, and platelets. This effect can cause anemia, decrease your||
1687|100|S|body's ability to fight an infection, or cause easy||
1687|101|S|bruising/bleeding. These effects may be fatal. Tell your doctor||
1687|102|S|right away if you develop any of the following symptoms: unusual||
1687|103|S|tiredness, pale skin, signs of infection (such as sore throat||
1687|104|S|that doesn't go away, fever, chills, shortness of breath), easy||
1687|105|S|bruising/bleeding, pink/bloody urine, black/bloody stools, vomit||
1687|106|S|that contains blood or looks like coffee grounds, coughing up||
1687|107|S|blood.||
1687|108|S|   Get medical help right away if you have any very serious signs||
1687|109|S|of bleeding, including: headache that is severe or doesn't go||
1687|110|S|away, trouble speaking, confusion.||
1687|111|S|   A very serious allergic reaction to this drug is rare.||
1687|112|S|However, get medical help right away if you notice any symptoms||
1687|113|S|of a serious allergic reaction, including: rash, itching/swelling||
1687|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1687|115|S|breathing.||
1687|116|S|   This is not a complete list of possible side effects. If you||
1687|117|S|notice other effects not listed above, contact your doctor or||
1687|118|S|pharmacist.||
1687|119|S|   In the US -||
1687|120|S|   Call your doctor for medical advice about side effects. You||
1687|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1687|122|S|www.fda.gov/medwatch.||
1687|123|S|   In Canada - Call your doctor for medical advice about side||
1687|124|S|effects. You may report side effects to Health Canada at||
1687|125|S|1-866-234-2345.||
1687|126|B|||
1687|127|P|PRECAUTIONS:  Before taking panobinostat, tell your doctor or||
1687|128|P|pharmacist if you are allergic to it; or if you have any other||
1687|129|P|allergies. This product may contain inactive ingredients, which||
1687|130|P|can cause allergic reactions or other problems. Talk to your||
1687|131|P|pharmacist for more details.||
1687|132|P|   Before using this medication, tell your doctor or pharmacist||
1687|133|P|your medical history, especially of: liver disease, heart disease||
1687|134|P|(such as chest pain, heart attack), current/recent infection,||
1687|135|P|frequent diarrhea, bleeding problems, blood disorders.||
1687|136|P|   Panobinostat may cause a condition that affects the heart||
1687|137|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1687|138|P|serious (rarely fatal) fast/irregular heartbeat and other||
1687|139|P|symptoms (such as severe dizziness, fainting) that need medical||
1687|140|P|attention right away.||
1687|141|P|   The risk of QT prolongation may be increased if you have||
1687|142|P|certain medical conditions or are taking other drugs that may||
1687|143|P|cause QT prolongation. Before using panobinostat, tell your||
1687|144|P|doctor or pharmacist of all the drugs you take and if you have||
1687|145|P|any of the following conditions: certain heart problems (heart||
1687|146|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1687|147|P|history of certain heart problems (QT prolongation in the EKG,||
1687|148|P|sudden cardiac death).||
1687|149|P|   Low levels of potassium or magnesium in the blood may also||
1687|150|P|increase your risk of QT prolongation. This risk may increase if||
1687|151|P|you use certain drugs (such as diuretics/"water pills") or if you||
1687|152|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1687|153|P|Talk to your doctor about using panobinostat safely.||
1687|154|P|   Panobinostat can make you more likely to get infections or may||
1687|155|P|make current infections worse. Stay away from anyone who has an||
1687|156|P|infection that may easily spread (such as chickenpox, COVID-19,||
1687|157|P|measles, flu). Talk to your doctor if you have been exposed to an||
1687|158|P|infection or for more details.||
1687|159|P|   Tell your health care professional that you are using||
1687|160|P|panobinostat before having any immunizations/vaccinations. Avoid||
1687|161|P|contact with people who have recently received live vaccines||
1687|162|P|(such as flu vaccine inhaled through the nose).||
1687|163|P|   To lower the chance of getting cut, bruised, or injured, use||
1687|164|P|caution with sharp objects like razors and nail cutters, and||
1687|165|P|avoid activities such as contact sports.||
1687|166|P|   Before having surgery, tell your doctor or dentist about all||
1687|167|P|the products you use (including prescription drugs,||
1687|168|P|nonprescription drugs, and herbal products).||
1687|169|P|   Older adults may be more sensitive to the side effects of this||
1687|170|P|drug, especially diarrhea, decreased bone marrow function, and QT||
1687|171|P|prolongation (see above).||
1687|172|P|   Tell your doctor if you are pregnant or plan to become||
1687|173|P|pregnant. You should not become pregnant while using||
1687|174|P|panobinostat. Panobinostat may harm an unborn baby. Your doctor||
1687|175|P|should order a pregnancy test before you start this medication.||
1687|176|P|Women using this medication should ask about reliable forms of||
1687|177|P|birth control during treatment and for at least 3 months after||
1687|178|P|the last dose. Men using this medication should ask about||
1687|179|P|reliable forms of birth control during treatment and for at least||
1687|180|P|6 months after the last dose. If you or your partner becomes||
1687|181|P|pregnant, talk to your doctor right away about the risks and||
1687|182|P|benefits of this medication.||
1687|183|P|   Since this drug can be absorbed through the skin and lungs and||
1687|184|P|may harm an unborn baby, women who are pregnant or who may become||
1687|185|P|pregnant should not handle this medication or breathe the dust||
1687|186|P|from the capsules.||
1687|187|P|   It is unknown if this drug passes into breast milk. Because of||
1687|188|P|the possible risk to the infant, breastfeeding is not recommended||
1687|189|P|while using this drug. Consult your doctor before breastfeeding.||
1687|190|B|||
1687|191|I|DRUG INTERACTIONS:  See also How to Use section.||
1687|192|I|   Drug interactions may change how your medications work or||
1687|193|I|increase your risk for serious side effects. This document does||
1687|194|I|not contain all possible drug interactions. Keep a list of all||
1687|195|I|the products you use (including prescription/nonprescription||
1687|196|I|drugs and herbal products) and share it with your doctor and||
1687|197|I|pharmacist. Do not start, stop, or change the dosage of any||
1687|198|I|medicines without your doctor's approval.||
1687|199|I|   Other medications can affect the removal of panobinostat from||
1687|200|I|your body, which may affect how panobinostat works. Examples||
1687|201|I|include carbamazepine, phenytoin, rifamycins (such as rifampin),||
1687|202|I|St. John's wort, among others.||
1687|203|B|||
1687|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1687|205|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1687|206|O|poison control center right away. US residents can call||
1687|207|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1687|208|O|Symptoms of overdose may include: severe||
1687|209|O|nausea/vomiting/diarrhea, easy bruising/bleeding.||
1687|210|B|||
1687|211|N|NOTES:  Do not share this medication with others.||
1687|212|N|   Lab and/or medical tests (such as complete blood count, ECG,||
1687|213|N|blood mineral levels, liver function) should be done before you||
1687|214|N|start taking this medication and while you are taking it. Keep||
1687|215|N|all medical and lab appointments. Consult your doctor for more||
1687|216|N|details.||
1687|217|B|||
1687|218|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1687|219|D|remember. If it is more than 12 hours after the missed dose, skip||
1687|220|D|the missed dose. Take your next dose at the regular time. Do not||
1687|221|D|double the dose to catch up.||
1687|222|B|||
1687|223|R|STORAGE:  Store in blister pack at room temperature away from||
1687|224|R|light and moisture. Keep the blister pack in the original carton||
1687|225|R|to protect from light. Do not store in the bathroom. Keep all||
1687|226|R|medications away from children and pets.||
1687|227|R|   Do not flush medications down the toilet or pour them into a||
1687|228|R|drain unless instructed to do so. Properly discard this product||
1687|229|R|when it is expired or no longer needed. Consult your pharmacist||
1687|230|R|or local waste disposal company.||
1687|231|B|||
1687|232|M|MEDICAL ALERT:  Your condition can cause complications in a||
1687|233|M|medical emergency. For information about enrolling in MedicAlert,||
1687|234|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1687|235|B|||
1687|236|A|Information last revised April 2025.||
1687|237|A|Copyright(c) 2025 First Databank, Inc.||
1687|238|B|||
1688|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1688|002|Z|does NOT have all possible information about this product. This||
1688|003|Z|information does not assure that this product is safe, effective,||
1688|004|Z|or appropriate for you. This information is not individual||
1688|005|Z|medical advice and does not substitute for the advice of your||
1688|006|Z|health care professional. Always ask your health care||
1688|007|Z|professional for complete information about this product and your||
1688|008|Z|specific health needs.||
1688|009|B|||
1688|010|T|METRONIDAZOLE SINGLE DOSE GEL - VAGINAL||
1688|011|F|(MET-roe-NID-a-zole)||
1688|012|B|||
1688|013|C|COMMON BRAND NAME(S): Nuvessa||
1688|014|B|||
1688|015|U|USES:  This medication is used to treat a certain type of vaginal||
1688|016|U|infection (bacterial vaginosis) in females 12 years of age and||
1688|017|U|older. Metronidazole is an antibiotic that works by stopping the||
1688|018|U|growth of bacteria.||
1688|019|B|||
1688|020|H|HOW TO USE:  Read the Patient Information Leaflet and the||
1688|021|H|Instructions for Use that come with this product before you start||
1688|022|H|using this medication. If you have any questions, ask your doctor||
1688|023|H|or pharmacist.||
1688|024|H|   This product is for vaginal use only. Wash your hands before||
1688|025|H|and after use. Avoid getting this medication in your eyes. If it||
1688|026|H|gets into your eyes, rinse them with cool water. Call your doctor||
1688|027|H|if eye irritation lasts.||
1688|028|H|   Insert the applicator filled with medication high into the||
1688|029|H|vagina and press the plunger to release the medication. This||
1688|030|H|product is given as a single dose at bedtime.||
1688|031|H|   Tell your doctor if your condition does not get better after||
1688|032|H|several days or if it gets worse.||
1688|033|B|||
1688|034|S|SIDE EFFECTS:  Although uncommon, dizziness, headache, or mild||
1688|035|S|stomach upset may occur. If any of these effects last or get||
1688|036|S|worse, tell your doctor or pharmacist promptly.||
1688|037|S|   Rarely, vaginal discomfort/itching/discharge may occur or||
1688|038|S|worsen. These symptoms may be due to a new vaginal infection||
1688|039|S|(such as a yeast/fungal infection). Contact your doctor if you||
1688|040|S|notice a change in vaginal discharge or other new vaginal||
1688|041|S|symptoms.||
1688|042|S|   Remember that this medication has been prescribed because your||
1688|043|S|doctor has judged that the benefit to you is greater than the||
1688|044|S|risk of side effects. Many people using this medication do not||
1688|045|S|have serious side effects.||
1688|046|S|   Get medical help right away if you have any very serious side||
1688|047|S|effects, including: numbness/tingling of the hands/feet,||
1688|048|S|seizures.||
1688|049|S|   A very serious allergic reaction to this drug is rare.||
1688|050|S|However, get medical help right away if you notice any symptoms||
1688|051|S|of a serious allergic reaction, including: fever that doesn't go||
1688|052|S|away, new or worsening lymph node swelling, rash,||
1688|053|S|itching/swelling (especially of the face/tongue/throat), severe||
1688|054|S|dizziness, trouble breathing.||
1688|055|S|   This is not a complete list of possible side effects. If you||
1688|056|S|notice other effects not listed above, contact your doctor or||
1688|057|S|pharmacist.||
1688|058|S|   In the US -||
1688|059|S|   Call your doctor for medical advice about side effects. You||
1688|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1688|061|S|www.fda.gov/medwatch.||
1688|062|S|   In Canada - Call your doctor for medical advice about side||
1688|063|S|effects. You may report side effects to Health Canada at||
1688|064|S|1-866-234-2345.||
1688|065|B|||
1688|066|P|PRECAUTIONS:  Before using metronidazole, tell your doctor or||
1688|067|P|pharmacist if you are allergic to it; or to other nitroimidazole||
1688|068|P|antibiotics (such as tinidazole); or if you have any other||
1688|069|P|allergies. This product may contain inactive ingredients (such as||
1688|070|P|paraben preservatives), which can cause allergic reactions or||
1688|071|P|other problems. Talk to your pharmacist for more details.||
1688|072|P|   Before using this medication, tell your doctor or pharmacist||
1688|073|P|your medical history, especially of: nervous system disorders||
1688|074|P|(such as seizures, numbness/tingling of the hands/feet).||
1688|075|P|   This drug may rarely make you dizzy. Alcohol or marijuana||
1688|076|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
1688|077|P|or do anything that needs alertness until you can do it safely.||
1688|078|P|Talk to your doctor if you are using marijuana (cannabis).||
1688|079|P|   Do not drink alcohol while using this medication and for at||
1688|080|P|least 24 hours after treatment. Drinking alcohol while using this||
1688|081|P|medication may cause stomach cramps, flushing, nausea, vomiting,||
1688|082|P|and headache.||
1688|083|P|   Do not have vaginal sex or use tampons or douches while using||
1688|084|P|this medication.||
1688|085|P|   During pregnancy, this medication should be used only when||
1688|086|P|clearly needed. Antibiotics taken by mouth have been used to||
1688|087|P|treat vaginal infections during pregnancy, especially high-risk||
1688|088|P|pregnancies (for example, if there is a risk of early||
1688|089|P|childbirth). Consult your doctor for more details and to discuss||
1688|090|P|the risks and benefits.||
1688|091|P|   It is unknown if this medication passes into breast milk.||
1688|092|P|Consult your doctor before breastfeeding.||
1688|093|B|||
1688|094|I|DRUG INTERACTIONS:  See also Precautions section.||
1688|095|I|   Drug interactions may change how your medications work or||
1688|096|I|increase your risk for serious side effects. This document does||
1688|097|I|not contain all possible drug interactions. Keep a list of all||
1688|098|I|the products you use (including prescription/nonprescription||
1688|099|I|drugs and herbal products) and share it with your doctor and||
1688|100|I|pharmacist. Do not start, stop, or change the dosage of any||
1688|101|I|medicines without your doctor's approval.||
1688|102|I|   Do not use this medication if you have taken disulfiram within||
1688|103|I|the last 2 weeks.||
1688|104|I|   Do not take products containing alcohol or propylene glycol||
1688|105|I|while using this medication and for at least 24 hours after||
1688|106|I|treatment. Ask your pharmacist for more details.||
1688|107|I|   This medication may interfere with certain lab tests, possibly||
1688|108|I|causing false test results. Make sure lab personnel and all your||
1688|109|I|doctors know you use this drug.||
1688|110|B|||
1688|111|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1688|112|O|has overdosed and has serious symptoms such as passing out or||
1688|113|O|trouble breathing, call 911. Otherwise, call a poison control||
1688|114|O|center right away. US residents can call 1-800-222-1222. Canada||
1688|115|O|residents can call 1-844-764-7669.||
1688|116|B|||
1688|117|N|NOTES:  Do not share this medication with others.||
1688|118|B|||
1688|119|D|MISSED DOSE:  Not applicable.||
1688|120|B|||
1688|121|R|STORAGE:  Store at room temperature. Do not refrigerate or||
1688|122|R|freeze. Keep all medications away from children and pets.||
1688|123|R|   Do not flush medications down the toilet or pour them into a||
1688|124|R|drain unless instructed to do so. Properly discard this product||
1688|125|R|when it is expired or no longer needed. Consult your pharmacist||
1688|126|R|or local waste disposal company.||
1688|127|B|||
1688|128|A|Information last revised November 2024.||
1688|129|A|Copyright(c) 2025 First Databank, Inc.||
1688|130|B|||
1689|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1689|002|Z|does NOT have all possible information about this product. This||
1689|003|Z|information does not assure that this product is safe, effective,||
1689|004|Z|or appropriate for you. This information is not individual||
1689|005|Z|medical advice and does not substitute for the advice of your||
1689|006|Z|health care professional. Always ask your health care||
1689|007|Z|professional for complete information about this product and your||
1689|008|Z|specific health needs.||
1689|009|B|||
1689|010|T|SODIUM PHENYLBUTYRATE GRANULES - ORAL||
1689|011|F|(SOE-dee-um FEN-il-BUE-ti-rate)||
1689|012|B|||
1689|013|C|COMMON BRAND NAME(S): Pheburane||
1689|014|B|||
1689|015|U|USES:  This medication is used along with diet changes for||
1689|016|U|long-term treatment of a certain inherited disorder (urea cycle||
1689|017|U|disorder). Sodium phenylbutyrate helps remove a certain chemical||
1689|018|U|(ammonia) from the body. Too much ammonia in the body can cause||
1689|019|U|brain damage and sometimes death.||
1689|020|U|   This medication should not be used to treat sudden, severely||
1689|021|U|high levels of ammonia in the body. Get medical help right away||
1689|022|U|if you have sudden symptoms of too much ammonia (such as trouble||
1689|023|U|thinking, nausea, vomiting, irritability, trouble speaking,||
1689|024|U|trouble walking, fainting).||
1689|025|B|||
1689|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1689|027|H|from your pharmacist before you start taking sodium||
1689|028|H|phenylbutyrate and each time you get a refill. If you have any||
1689|029|H|questions, ask your doctor or pharmacist.||
1689|030|H|   Take this medication by mouth exactly as directed by your||
1689|031|H|doctor. The dosage is based on your weight or body size, medical||
1689|032|H|condition, and response to treatment. The total daily dose should||
1689|033|H|be divided into equal amounts and taken with each meal or feeding||
1689|034|H|(such as 3 to 6 times daily). Do not increase or decrease your||
1689|035|H|dose without your doctor's approval.||
1689|036|H|   Carefully measure the dose using a special measuring||
1689|037|H|device/spoon. Take this medication with water, fruit juice, or||
1689|038|H|protein-free infant formula. You may also sprinkle the dose onto||
1689|039|H|a spoonful of solid food (such as apple sauce) and eat right away||
1689|040|H|to prevent salty taste. Do not chew the medication. Do not||
1689|041|H|prepare a supply in advance.||
1689|042|H|   Some brands may be given by a feeding tube||
1689|043|H|(nasogastric/gastric). For specific directions, ask your health||
1689|044|H|care professional.||
1689|045|H|   Use this medication regularly to get the most benefit from it.||
1689|046|H|To help you remember, take it at the same times each day.||
1689|047|B|||
1689|048|S|SIDE EFFECTS:  Loss of appetite or menstrual changes||
1689|049|S|(delayed/irregular/absent periods) may occur. If any of these||
1689|050|S|effects last or get worse, tell your doctor or pharmacist||
1689|051|S|promptly.||
1689|052|S|   Remember that this medication has been prescribed because your||
1689|053|S|doctor has judged that the benefit to you is greater than the||
1689|054|S|risk of side effects. Many people using this medication do not||
1689|055|S|have serious side effects.||
1689|056|S|   Tell your doctor right away if you have any serious side||
1689|057|S|effects, including: drowsiness/lightheadedness, fast/pounding||
1689|058|S|heartbeat, mental/mood changes (such as confusion), unusual||
1689|059|S|tiredness.||
1689|060|S|   A very serious allergic reaction to this drug is rare.||
1689|061|S|However, get medical help right away if you notice any symptoms||
1689|062|S|of a serious allergic reaction, including: rash, itching/swelling||
1689|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1689|064|S|breathing.||
1689|065|S|   This is not a complete list of possible side effects. If you||
1689|066|S|notice other effects not listed above, contact your doctor or||
1689|067|S|pharmacist.||
1689|068|S|   In the US -||
1689|069|S|   Call your doctor for medical advice about side effects. You||
1689|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1689|071|S|www.fda.gov/medwatch.||
1689|072|S|   In Canada - Call your doctor for medical advice about side||
1689|073|S|effects. You may report side effects to Health Canada at||
1689|074|S|1-866-234-2345.||
1689|075|B|||
1689|076|P|PRECAUTIONS:  Before taking sodium phenylbutyrate, tell your||
1689|077|P|doctor or pharmacist if you are allergic to it; or if you have||
1689|078|P|any other allergies. This product may contain inactive||
1689|079|P|ingredients, which can cause allergic reactions or other||
1689|080|P|problems. Talk to your pharmacist for more details.||
1689|081|P|   Before using this medication, tell your doctor or pharmacist||
1689|082|P|your medical history, especially of: a certain heart problem||
1689|083|P|(heart failure), kidney disease, liver disease, swelling (edema).||
1689|084|P|   This medication contains salt (sodium). Before taking this||
1689|085|P|medication, tell your doctor or pharmacist if you are on a||
1689|086|P|low-salt diet.||
1689|087|P|   Some brands of this medication may contain sugar. Caution is||
1689|088|P|advised if you have diabetes, fructose intolerance, or any other||
1689|089|P|condition that requires you to limit/avoid sugar in your diet.||
1689|090|P|Ask your doctor or pharmacist about using this medication safely.||
1689|091|P|   Before having surgery, tell your doctor or dentist about all||
1689|092|P|the products you use (including prescription drugs,||
1689|093|P|nonprescription drugs, and herbal products).||
1689|094|P|   During pregnancy, this medication should be used only when||
1689|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1689|096|P|   It is unknown if this medication passes into breast milk.||
1689|097|P|Consult your doctor before breastfeeding.||
1689|098|B|||
1689|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1689|100|I|medications work or increase your risk for serious side effects.||
1689|101|I|This document does not contain all possible drug interactions.||
1689|102|I|Keep a list of all the products you use (including||
1689|103|I|prescription/nonprescription drugs and herbal products) and share||
1689|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1689|105|I|the dosage of any medicines without your doctor's approval.||
1689|106|B|||
1689|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1689|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1689|109|O|poison control center right away. US residents can call||
1689|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1689|111|B|||
1689|112|N|NOTES:  Do not share this medication with others.||
1689|113|N|   Lab and/or medical tests (such as plasma ammonia/amino acid||
1689|114|N|levels, complete blood count, blood potassium level, urine tests,||
1689|115|N|drug levels) should be done while you are taking this medication.||
1689|116|N|Keep all medical and lab appointments. Consult your doctor for||
1689|117|N|more details.||
1689|118|B|||
1689|119|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1689|120|D|remember. If it is within 3 hours of the next dose, skip the||
1689|121|D|missed dose. Take your next dose at the regular time. Do not||
1689|122|D|double the dose to catch up.||
1689|123|B|||
1689|124|R|STORAGE:  Store the granules at room temperature away from light||
1689|125|R|and moisture. Do not store in the bathroom. Once the bottle is||
1689|126|R|opened, this medication expires after 45 days. Keep all||
1689|127|R|medications away from children and pets.||
1689|128|R|   Do not flush medications down the toilet or pour them into a||
1689|129|R|drain unless instructed to do so. Properly discard this product||
1689|130|R|when it is expired or no longer needed. Consult your pharmacist||
1689|131|R|or local waste disposal company.||
1689|132|B|||
1689|133|A|Information last revised January 2025.||
1689|134|A|Copyright(c) 2025 First Databank, Inc.||
1689|135|B|||
1690|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1690|002|Z|does NOT have all possible information about this product. This||
1690|003|Z|information does not assure that this product is safe, effective,||
1690|004|Z|or appropriate for you. This information is not individual||
1690|005|Z|medical advice and does not substitute for the advice of your||
1690|006|Z|health care professional. Always ask your health care||
1690|007|Z|professional for complete information about this product and your||
1690|008|Z|specific health needs.||
1690|009|B|||
1690|010|T|TESTOSTERONE GEL - NASAL||
1690|011|F|(tes-TOS-ter-one)||
1690|012|B|||
1690|013|C|COMMON BRAND NAME(S): Natesto||
1690|014|B|||
1690|015|U|USES:  This medication is used by men who do not make enough of a||
1690|016|U|natural substance called testosterone (hypogonadism).||
1690|017|U|Testosterone belongs to a class of drugs known as androgens.||
1690|018|U|Testosterone helps the body to develop and maintain male sexual||
1690|019|U|characteristics (masculinity), such as a deep voice and body||
1690|020|U|hair. It also helps to maintain muscle and prevent bone loss, and||
1690|021|U|is necessary for natural sexual ability/desire.||
1690|022|U|   This drug should not be used by women.||
1690|023|B|||
1690|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1690|025|H|from your pharmacist before you start using testosterone and each||
1690|026|H|time you get a refill. Follow the illustrated directions for the||
1690|027|H|proper use of this medication. If you have any questions, ask||
1690|028|H|your doctor or pharmacist.||
1690|029|H|   Gently blow your nose before using this medication. Follow the||
1690|030|H|instructions on how to properly prime the bottle if you are using||
1690|031|H|it for the first time.||
1690|032|H|   Use this medication in the nose as directed by your doctor,||
1690|033|H|usually 3 times a day (6 to 8 hours apart). After applying the||
1690|034|H|medication into both nostrils, gently squeeze your nostrils||
1690|035|H|together and lightly massage. Do not apply this medication to||
1690|036|H|other areas of your body. If another part of your body comes in||
1690|037|H|contact with this medication, wash the area with warm water and||
1690|038|H|soap.||
1690|039|H|   Do not blow your nose or sniff for 1 hour after using this||
1690|040|H|medication. Wipe the tip of the applicator with a clean, dry||
1690|041|H|tissue after each use.||
1690|042|H|   Use this medication regularly to get the most benefit from it.||
1690|043|H|To help you remember, use it at the same times each day.||
1690|044|H|   Misuse or abuse of testosterone can cause serious side effects||
1690|045|H|such as heart disease (including heart attack), stroke, liver||
1690|046|H|disease, mental/mood problems, abnormal drug-seeking behavior, or||
1690|047|H|improper bone growth (in adolescents). Do not increase your dose||
1690|048|H|or use this drug more often or for longer than prescribed. When||
1690|049|H|testosterone is misused or abused, you may have withdrawal||
1690|050|H|symptoms (such as depression, irritability, tiredness) when you||
1690|051|H|suddenly stop using the drug. These symptoms may last from weeks||
1690|052|H|to months.||
1690|053|H|   Since this drug can be absorbed through the skin and may harm||
1690|054|H|an unborn baby, women who are pregnant or who may become pregnant||
1690|055|H|should not handle this medication.||
1690|056|H|   Tell your doctor if your condition does not get better or if||
1690|057|H|it gets worse.||
1690|058|B|||
1690|059|S|SIDE EFFECTS:  Runny/stuffy nose, nosebleed, nasal||
1690|060|S|dryness/irritation/scabbing or changes in smell may occur. If any||
1690|061|S|of these effects last or get worse, tell your doctor or||
1690|062|S|pharmacist promptly.||
1690|063|S|   Remember that this medication has been prescribed because your||
1690|064|S|doctor has judged that the benefit to you is greater than the||
1690|065|S|risk of side effects. Many people using this medication do not||
1690|066|S|have serious side effects.||
1690|067|S|   This medication may raise your blood pressure. Check your||
1690|068|S|blood pressure regularly and tell your doctor if the results are||
1690|069|S|high. Your doctor may control your blood pressure with||
1690|070|S|medication.||
1690|071|S|   Tell your doctor right away if you have any serious side||
1690|072|S|effects, including: difficulty urinating, increased urination||
1690|073|S|(especially at night), signs of liver problems (such as||
1690|074|S|nausea/vomiting that doesn't stop, loss of appetite,||
1690|075|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1690|076|S|swelling hands/ankle/feet, breast pain/enlargement, interrupted||
1690|077|S|breathing during sleep, daytime drowsiness, frequent erections,||
1690|078|S|fast/irregular heartbeat.||
1690|079|S|   Get medical help right away if you have any very serious side||
1690|080|S|effects, including: shortness of breath/rapid breathing,||
1690|081|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1690|082|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1690|083|S|sudden/severe headaches, trouble speaking, weakness on one side||
1690|084|S|of the body, sudden vision changes.||
1690|085|S|   Rarely, males may have a painful or prolonged erection lasting||
1690|086|S|4 or more hours. If this occurs, stop using this drug and get||
1690|087|S|medical help right away, or permanent problems could occur.||
1690|088|S|   A very serious allergic reaction to this drug is rare.||
1690|089|S|However, get medical help right away if you notice any symptoms||
1690|090|S|of a serious allergic reaction, including: rash, itching/swelling||
1690|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1690|092|S|breathing.||
1690|093|S|   This is not a complete list of possible side effects. If you||
1690|094|S|notice other effects not listed above, contact your doctor or||
1690|095|S|pharmacist.||
1690|096|S|   In the US -||
1690|097|S|   Call your doctor for medical advice about side effects. You||
1690|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1690|099|S|www.fda.gov/medwatch.||
1690|100|S|   In Canada - Call your doctor for medical advice about side||
1690|101|S|effects. You may report side effects to Health Canada at||
1690|102|S|1-866-234-2345.||
1690|103|B|||
1690|104|P|PRECAUTIONS:  Before using testosterone, tell your doctor or||
1690|105|P|pharmacist if you are allergic to it; or if you have any other||
1690|106|P|allergies. This product may contain inactive ingredients, which||
1690|107|P|can cause allergic reactions or other problems. Talk to your||
1690|108|P|pharmacist for more details.||
1690|109|P|   Before using this medication, tell your doctor or pharmacist||
1690|110|P|your medical history, especially of: nasal problems (such as||
1690|111|P|runny/stuffy nose, swelling of the lining of your nose), seasonal||
1690|112|P|allergies, history of a broken nose within the past 6 months, a||
1690|113|P|fracture of your nose that caused the inside of your nose to be||
1690|114|P|crooked (deviated anterior nasal septum), sinus problem, nasal or||
1690|115|P|sinus surgery, cancer (especially prostate or breast cancer),||
1690|116|P|prostate problems (such as enlarged prostate or BPH), blood clots||
1690|117|P|(such as in the legs, lungs), heart problems (such as heart||
1690|118|P|failure, heart attack), stroke, breathing trouble during sleep||
1690|119|P|(sleep apnea), kidney disease, liver disease, high cholesterol,||
1690|120|P|diabetes, high blood pressure.||
1690|121|P|   If you have diabetes, this product may affect your blood||
1690|122|P|sugar. Check your blood sugar regularly as directed and share the||
1690|123|P|results with your doctor. Tell your doctor right away if you have||
1690|124|P|symptoms of low blood sugar. Your doctor may need to adjust your||
1690|125|P|diabetes medication, exercise program, or diet.||
1690|126|P|   Before having surgery, tell your doctor or dentist about all||
1690|127|P|the products you use (including prescription drugs,||
1690|128|P|nonprescription drugs, and herbal products).||
1690|129|P|   Some men, particularly older adults, are at a higher risk for||
1690|130|P|developing enlarged prostate or prostate cancer while using this||
1690|131|P|medication. Your risk of prostate problems should be checked by||
1690|132|P|your doctor before you start testosterone.||
1690|133|P|   Children may be more sensitive to the side effects of this||
1690|134|P|drug. In children, it may affect bone growth. Monitor your||
1690|135|P|child's height periodically.||
1690|136|P|   This medication can affect fertility in males. Ask your doctor||
1690|137|P|for more details.||
1690|138|P|   This medication should not be used by women. Women||
1690|139|P|accidentally exposed to this medication may have side effects due||
1690|140|P|to testosterone gel. If you notice symptoms in a woman such as||
1690|141|P|changes in body hair or a large increase in acne, talk to her||
1690|142|P|doctor and your doctor right away. Women who are pregnant or||
1690|143|P|breastfeeding must avoid contact with this medication. This||
1690|144|P|medication may harm an unborn or breastfeeding baby. Consult your||
1690|145|P|doctor for more details.||
1690|146|B|||
1690|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1690|148|I|medications work or increase your risk for serious side effects.||
1690|149|I|This document does not contain all possible drug interactions.||
1690|150|I|Keep a list of all the products you use (including||
1690|151|I|prescription/nonprescription drugs and herbal products) and share||
1690|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
1690|153|I|the dosage of any medicines without your doctor's approval.||
1690|154|I|   Some products that may interact with this drug include: "blood||
1690|155|I|thinners" (such as warfarin).||
1690|156|I|   This medication may interfere with certain lab tests (such as||
1690|157|I|thyroid tests), possibly causing false test results. Make sure||
1690|158|I|lab personnel and all your doctors know you use this drug.||
1690|159|B|||
1690|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1690|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1690|162|O|poison control center right away. US residents can call||
1690|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1690|164|B|||
1690|165|N|NOTES:  Do not share this medication with others. Sharing it is||
1690|166|N|against the law.||
1690|167|N|   Lab and/or medical tests (such as PSA, cholesterol,||
1690|168|N|hemoglobin/hematocrit, testosterone blood levels, prostate exams)||
1690|169|N|should be done before you start using this medication and while||
1690|170|N|you are using it. Keep all medical and lab appointments. Consult||
1690|171|N|your doctor for more details.||
1690|172|B|||
1690|173|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1690|174|D|If it is near the time of the next dose, skip the missed dose.||
1690|175|D|Use your next dose at the regular time. Do not double the dose to||
1690|176|D|catch up.||
1690|177|B|||
1690|178|R|STORAGE:  Store at room temperature. Keep all medications away||
1690|179|R|from children and pets.||
1690|180|R|   Do not flush medications down the toilet or pour them into a||
1690|181|R|drain unless instructed to do so. Properly discard this product||
1690|182|R|when it is expired or no longer needed. Consult your pharmacist||
1690|183|R|or local waste disposal company.||
1690|184|B|||
1690|185|A|Information last revised March 2025.||
1690|186|A|Copyright(c) 2025 First Databank, Inc.||
1690|187|B|||
1691|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1691|002|Z|does NOT have all possible information about this product. This||
1691|003|Z|information does not assure that this product is safe, effective,||
1691|004|Z|or appropriate for you. This information is not individual||
1691|005|Z|medical advice and does not substitute for the advice of your||
1691|006|Z|health care professional. Always ask your health care||
1691|007|Z|professional for complete information about this product and your||
1691|008|Z|specific health needs.||
1691|009|B|||
1691|010|T|ISAVUCONAZONIUM - ORAL||
1691|011|F|(EYE-sa-vue-KOE-na-ZOE-nee-um)||
1691|012|B|||
1691|013|C|COMMON BRAND NAME(S): Cresemba||
1691|014|B|||
1691|015|U|USES:  This medication is used to treat certain serious fungal||
1691|016|U|infections. This medication is known as an azole antifungal. It||
1691|017|U|works by stopping the growth of fungi.||
1691|018|B|||
1691|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1691|020|H|from your pharmacist before you start taking this medication and||
1691|021|H|each time you get a refill. If you have any questions, ask your||
1691|022|H|doctor or pharmacist.||
1691|023|H|   Take this medication by mouth with or without food as directed||
1691|024|H|by your doctor, usually every 8 hours for the first 6 doses (48||
1691|025|H|hours). Then 12 to 24 hours after the first 6 doses, take this||
1691|026|H|medication once daily. Children's dosage is based on weight.||
1691|027|H|   The manufacturer directs not to chew, crush, dissolve, or open||
1691|028|H|the capsule before taking it. However, many similar drugs||
1691|029|H|(immediate-release capsules) can be chewed, crushed, dissolved,||
1691|030|H|or opened. Follow your doctor's directions on how to take this||
1691|031|H|medication.||
1691|032|H|   This medication works best when the amount of medicine in your||
1691|033|H|body is kept at a constant level. Take this drug at evenly spaced||
1691|034|H|intervals.||
1691|035|H|   Continue to take this medication until the full prescribed||
1691|036|H|amount is finished, even if symptoms disappear after a few days.||
1691|037|H|Stopping the medication too early may result in a return of the||
1691|038|H|infection.||
1691|039|H|   Tell your doctor if your condition does not get better or if||
1691|040|H|it gets worse.||
1691|041|B|||
1691|042|S|SIDE EFFECTS:  Dizziness, nausea, vomiting, diarrhea, headache,||
1691|043|S|constipation, cough, and trouble sleeping may occur. If any of||
1691|044|S|these effects last or get worse, tell your doctor or pharmacist||
1691|045|S|promptly.||
1691|046|S|   Remember that this medication has been prescribed because your||
1691|047|S|doctor has judged that the benefit to you is greater than the||
1691|048|S|risk of side effects. Many people using this medication do not||
1691|049|S|have serious side effects.||
1691|050|S|   Tell your doctor right away if you have any serious side||
1691|051|S|effects, including: muscle cramps/spasms, weakness, swelling||
1691|052|S|hands/ankles/feet, back pain, mental/mood changes (such as||
1691|053|S|confusion, anxiety).||
1691|054|S|   Get medical help right away if you have any very serious side||
1691|055|S|effects, including: fast/irregular/pounding heartbeat, chest||
1691|056|S|pain, fainting, signs of kidney problems (such as change in the||
1691|057|S|amount of urine), seizures.||
1691|058|S|   Isavuconazonium may rarely cause serious (possibly fatal)||
1691|059|S|liver disease. Get medical help right away if you have any||
1691|060|S|symptoms of liver damage, including: nausea/vomiting that doesn't||
1691|061|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
1691|062|S|eyes/skin, dark urine.||
1691|063|S|   Isavuconazonium can commonly cause a rash that is usually not||
1691|064|S|serious. However, you may not be able to tell it apart from a||
1691|065|S|rare rash that could be a sign of a severe reaction. Tell your||
1691|066|S|doctor right away if you develop any rash.||
1691|067|S|   A very serious allergic reaction to this drug is rare.||
1691|068|S|However, get medical help right away if you notice any symptoms||
1691|069|S|of a serious allergic reaction, including: rash, itching/swelling||
1691|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1691|071|S|breathing.||
1691|072|S|   This is not a complete list of possible side effects. If you||
1691|073|S|notice other effects not listed above, contact your doctor or||
1691|074|S|pharmacist.||
1691|075|S|   In the US -||
1691|076|S|   Call your doctor for medical advice about side effects. You||
1691|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1691|078|S|www.fda.gov/medwatch.||
1691|079|S|   In Canada - Call your doctor for medical advice about side||
1691|080|S|effects. You may report side effects to Health Canada at||
1691|081|S|1-866-234-2345.||
1691|082|B|||
1691|083|P|PRECAUTIONS:  Before taking isavuconazonium, tell your doctor or||
1691|084|P|pharmacist if you are allergic to it; or if you have any other||
1691|085|P|allergies. This product may contain inactive ingredients, which||
1691|086|P|can cause allergic reactions or other problems. Talk to your||
1691|087|P|pharmacist for more details.||
1691|088|P|   Before using this medication, tell your doctor or pharmacist||
1691|089|P|your medical history, especially of: liver disease, family||
1691|090|P|history of certain heart problems (short QT syndrome, abnormal||
1691|091|P|heart rate/rhythm).||
1691|092|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1691|093|P|can make you more dizzy. Do not drive, use machinery, or do||
1691|094|P|anything that needs alertness until you can do it safely. Limit||
1691|095|P|alcoholic beverages. Talk to your doctor if you are using||
1691|096|P|marijuana (cannabis).||
1691|097|P|   Before having surgery, tell your doctor or dentist about all||
1691|098|P|the products you use (including prescription drugs,||
1691|099|P|nonprescription drugs, and herbal products).||
1691|100|P|   Tell your doctor if you are pregnant or plan to become||
1691|101|P|pregnant. You should not become pregnant while using||
1691|102|P|isavuconazonium. Isavuconazonium may harm an unborn baby. Ask||
1691|103|P|about reliable forms of birth control while using this medication||
1691|104|P|and for 28 days after the last dose. If you become pregnant, talk||
1691|105|P|to your doctor right away about the risks and benefits of this||
1691|106|P|medication.||
1691|107|P|   It is unknown if this drug passes into breast milk.||
1691|108|P|Breastfeeding is not recommended while using this drug. Consult||
1691|109|P|your doctor before breastfeeding.||
1691|110|B|||
1691|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1691|112|I|medications work or increase your risk for serious side effects.||
1691|113|I|This document does not contain all possible drug interactions.||
1691|114|I|Keep a list of all the products you use (including||
1691|115|I|prescription/nonprescription drugs and herbal products) and share||
1691|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1691|117|I|the dosage of any medicines without your doctor's approval.||
1691|118|I|   This medication can slow down the removal of other medications||
1691|119|I|from your body, which may affect how they work. Examples of||
1691|120|I|affected drugs include bosutinib, dofetilide, elacestrant,||
1691|121|I|flibanserin, lomitapide, tolvaptan, among others.||
1691|122|I|   Other medications can affect the removal of isavuconazonium||
1691|123|I|from your body, which may affect how isavuconazonium works.||
1691|124|I|Examples include adagrasib, certain azole antifungals (such as||
1691|125|I|itraconazole, ketoconazole), cobicistat, certain HIV protease||
1691|126|I|inhibitors (such as nelfinavir), nefazodone, certain rifamycins||
1691|127|I|(such as rifabutin, rifampin), ritonavir, certain drugs used to||
1691|128|I|treat seizures (such as carbamazepine, phenobarbital), St. John's||
1691|129|I|wort, among others.||
1691|130|B|||
1691|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1691|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1691|133|O|poison control center right away. US residents can call||
1691|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1691|135|B|||
1691|136|N|NOTES:  Do not share this medication with others.||
1691|137|N|   This medication has been prescribed for your current condition||
1691|138|N|only. Do not use it later for another infection unless your||
1691|139|N|doctor tells you to.||
1691|140|N|   Lab and/or medical tests (such as liver function) should be||
1691|141|N|done while you are taking this medication. Keep all medical and||
1691|142|N|lab appointments. Consult your doctor for more details.||
1691|143|B|||
1691|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1691|145|D|remember. If it is near the time of the next dose, skip the||
1691|146|D|missed dose. Take your next dose at the regular time. Do not||
1691|147|D|double the dose to catch up.||
1691|148|B|||
1691|149|R|STORAGE:  Store in the original container at room temperature||
1691|150|R|away from light and moisture. Do not store in the bathroom. Keep||
1691|151|R|all medications away from children and pets.||
1691|152|R|   Do not flush medications down the toilet or pour them into a||
1691|153|R|drain unless instructed to do so. Properly discard this product||
1691|154|R|when it is expired or no longer needed. Consult your pharmacist||
1691|155|R|or local waste disposal company.||
1691|156|B|||
1691|157|A|Information last revised August 2025.||
1691|158|A|Copyright(c) 2025 First Databank, Inc.||
1691|159|B|||
1692|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1692|002|Z|does NOT have all possible information about this product. This||
1692|003|Z|information does not assure that this product is safe, effective,||
1692|004|Z|or appropriate for you. This information is not individual||
1692|005|Z|medical advice and does not substitute for the advice of your||
1692|006|Z|health care professional. Always ask your health care||
1692|007|Z|professional for complete information about this product and your||
1692|008|Z|specific health needs.||
1692|009|B|||
1692|010|T|ISAVUCONAZONIUM - INJECTION||
1692|011|F|(EYE-sa-vue-KOE-na-ZOE-nee-um)||
1692|012|B|||
1692|013|C|COMMON BRAND NAME(S): Cresemba||
1692|014|B|||
1692|015|U|USES:  This medication is used to treat certain serious fungal||
1692|016|U|infections. This medication is known as an azole antifungal. It||
1692|017|U|works by stopping the growth of fungi.||
1692|018|B|||
1692|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1692|020|H|from your pharmacist before you start using this medication and||
1692|021|H|each time you get a refill. If you have any questions, ask your||
1692|022|H|doctor or pharmacist.||
1692|023|H|   This medication is given by injection into a vein as directed||
1692|024|H|by your doctor, usually every 8 hours for the first 6 doses (48||
1692|025|H|hours). Then 12 to 24 hours after the first 6 doses, it will be||
1692|026|H|given once daily. This medication should be injected slowly over||
1692|027|H|1 hour. Children's dosage is based on weight.||
1692|028|H|   If you are using this medication at home, learn all||
1692|029|H|preparation and usage instructions from your health care||
1692|030|H|professional. You should use an in-line filter with this||
1692|031|H|medication. This product may contain white particles. Before||
1692|032|H|using, check this product for other particles or discoloration.||
1692|033|H|If either is present, do not use the liquid. Learn how to store||
1692|034|H|and discard medical supplies safely.||
1692|035|H|   Infusion reactions may happen during the infusion of this||
1692|036|H|drug. Tell your doctor right away if you have symptoms of||
1692|037|H|infusion reactions such as dizziness, shortness of breath,||
1692|038|H|chills, numb/tingling skin, or changes in your sense of touch.||
1692|039|H|Your doctor may stop your treatment.||
1692|040|H|   If you are giving this medication through a nasogastric tube,||
1692|041|H|ask your health care professional for detailed instructions on||
1692|042|H|how to properly mix and give it.||
1692|043|H|   This medication works best when the amount of medicine in your||
1692|044|H|body is kept at a constant level. Use this drug at evenly spaced||
1692|045|H|intervals.||
1692|046|H|   Continue to use this medication until the full prescribed||
1692|047|H|amount is finished, even if symptoms disappear after a few days.||
1692|048|H|Stopping the medication too early may result in a return of the||
1692|049|H|infection.||
1692|050|H|   Tell your doctor if your condition does not get better or if||
1692|051|H|it gets worse.||
1692|052|B|||
1692|053|S|SIDE EFFECTS:  See also How to Use section.||
1692|054|S|   Nausea, vomiting, diarrhea, headache, constipation, cough, and||
1692|055|S|trouble sleeping may occur. If any of these effects last or get||
1692|056|S|worse, tell your doctor or pharmacist promptly.||
1692|057|S|   Remember that this medication has been prescribed because your||
1692|058|S|doctor has judged that the benefit to you is greater than the||
1692|059|S|risk of side effects. Many people using this medication do not||
1692|060|S|have serious side effects.||
1692|061|S|   Tell your doctor right away if you have any serious side||
1692|062|S|effects, including: muscle cramps/spasms, weakness, swelling||
1692|063|S|hands/ankles/feet, back pain, mental/mood changes (such as||
1692|064|S|confusion, anxiety).||
1692|065|S|   Get medical help right away if you have any very serious side||
1692|066|S|effects, including: fast/irregular/pounding heartbeat, chest||
1692|067|S|pain, fainting, signs of kidney problems (such as change in the||
1692|068|S|amount of urine), seizures.||
1692|069|S|   Isavuconazonium may rarely cause serious (possibly fatal)||
1692|070|S|liver disease. Get medical help right away if you have any||
1692|071|S|symptoms of liver damage, including: nausea/vomiting that doesn't||
1692|072|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
1692|073|S|eyes/skin, dark urine.||
1692|074|S|   Isavuconazonium can commonly cause a rash that is usually not||
1692|075|S|serious. However, you may not be able to tell it apart from a||
1692|076|S|rare rash that could be a sign of a severe reaction. Get medical||
1692|077|S|help right away if you develop any rash.||
1692|078|S|   A very serious allergic reaction to this drug is rare.||
1692|079|S|However, get medical help right away if you notice any symptoms||
1692|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1692|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1692|082|S|breathing.||
1692|083|S|   This is not a complete list of possible side effects. If you||
1692|084|S|notice other effects not listed above, contact your doctor or||
1692|085|S|pharmacist.||
1692|086|S|   In the US -||
1692|087|S|   Call your doctor for medical advice about side effects. You||
1692|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1692|089|S|www.fda.gov/medwatch.||
1692|090|S|   In Canada - Call your doctor for medical advice about side||
1692|091|S|effects. You may report side effects to Health Canada at||
1692|092|S|1-866-234-2345.||
1692|093|B|||
1692|094|P|PRECAUTIONS:  Before using isavuconazonium, tell your doctor or||
1692|095|P|pharmacist if you are allergic to it; or if you have any other||
1692|096|P|allergies. This product may contain inactive ingredients, which||
1692|097|P|can cause allergic reactions or other problems. Talk to your||
1692|098|P|pharmacist for more details.||
1692|099|P|   Before using this medication, tell your doctor or pharmacist||
1692|100|P|your medical history, especially of: liver disease, family||
1692|101|P|history of certain heart problems (short QT syndrome, abnormal||
1692|102|P|heart rate/rhythm).||
1692|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1692|104|P|can make you more dizzy. Do not drive, use machinery, or do||
1692|105|P|anything that needs alertness until you can do it safely. Limit||
1692|106|P|alcoholic beverages. Talk to your doctor if you are using||
1692|107|P|marijuana (cannabis).||
1692|108|P|   Before having surgery, tell your doctor or dentist about all||
1692|109|P|the products you use (including prescription drugs,||
1692|110|P|nonprescription drugs, and herbal products).||
1692|111|P|   Tell your doctor if you are pregnant or plan to become||
1692|112|P|pregnant. You should not become pregnant while using||
1692|113|P|isavuconazonium. Isavuconazonium may harm an unborn baby. Ask||
1692|114|P|about reliable forms of birth control while using this medication||
1692|115|P|and for 28 days after the last dose. If you become pregnant, talk||
1692|116|P|to your doctor right away about the risks and benefits of this||
1692|117|P|medication.||
1692|118|P|   It is unknown if this drug passes into breast milk.||
1692|119|P|Breastfeeding is not recommended while using this drug. Consult||
1692|120|P|your doctor before breastfeeding.||
1692|121|B|||
1692|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1692|123|I|medications work or increase your risk for serious side effects.||
1692|124|I|This document does not contain all possible drug interactions.||
1692|125|I|Keep a list of all the products you use (including||
1692|126|I|prescription/nonprescription drugs and herbal products) and share||
1692|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
1692|128|I|the dosage of any medicines without your doctor's approval.||
1692|129|I|   This medication can slow down the removal of other medications||
1692|130|I|from your body, which may affect how they work. Examples of||
1692|131|I|affected drugs include bosutinib, dofetilide, elacestrant,||
1692|132|I|flibanserin, lomitapide, tolvaptan, among others.||
1692|133|I|   Other medications can affect the removal of isavuconazonium||
1692|134|I|from your body, which may affect how isavuconazonium works.||
1692|135|I|Examples include adagrasib, certain azole antifungals (such as||
1692|136|I|itraconazole, ketoconazole), cobicistat, certain HIV protease||
1692|137|I|inhibitors (such as nelfinavir), nefazodone, certain rifamycins||
1692|138|I|(such as rifabutin, rifampin), ritonavir, certain drugs used to||
1692|139|I|treat seizures (such as carbamazepine, phenobarbital), St. John's||
1692|140|I|wort, among others.||
1692|141|B|||
1692|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1692|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1692|144|O|poison control center right away. US residents can call||
1692|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1692|146|B|||
1692|147|N|NOTES:  Lab and/or medical tests (such as liver function) should||
1692|148|N|be done while you are using this medication. Keep all medical and||
1692|149|N|lab appointments. Consult your doctor for more details.||
1692|150|B|||
1692|151|D|MISSED DOSE:  It is important to get each dose of this medication||
1692|152|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1692|153|D|right away for a new dosing schedule. Do not double the dose to||
1692|154|D|catch up.||
1692|155|B|||
1692|156|R|STORAGE:  Consult the product instructions and your pharmacist||
1692|157|R|for storage details. Keep all medications away from children and||
1692|158|R|pets.||
1692|159|R|   Do not flush medications down the toilet or pour them into a||
1692|160|R|drain unless instructed to do so. Properly discard this product||
1692|161|R|when it is expired or no longer needed. Consult your pharmacist||
1692|162|R|or local waste disposal company.||
1692|163|B|||
1692|164|A|Information last revised August 2025.||
1692|165|A|Copyright(c) 2025 First Databank, Inc.||
1692|166|B|||
1693|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1693|002|Z|does NOT have all possible information about this product. This||
1693|003|Z|information does not assure that this product is safe, effective,||
1693|004|Z|or appropriate for you. This information is not individual||
1693|005|Z|medical advice and does not substitute for the advice of your||
1693|006|Z|health care professional. Always ask your health care||
1693|007|Z|professional for complete information about this product and your||
1693|008|Z|specific health needs.||
1693|009|B|||
1693|010|T|CEFTAZIDIME/AVIBACTAM - INJECTION||
1693|011|F|(sef-TAZ-i-deem/a-vi-BAK-tam)||
1693|012|B|||
1693|013|C|COMMON BRAND NAME(S): Avycaz||
1693|014|B|||
1693|015|U|USES:  This medication is used to treat a wide variety of||
1693|016|U|bacterial infections. This product contains 2 different||
1693|017|U|medications: ceftazidime and avibactam. Ceftazidime is a||
1693|018|U|cephalosporin antibiotic that works by stopping the growth of||
1693|019|U|bacteria. Avibactam is an enzyme inhibitor (beta-lactamase||
1693|020|U|inhibitor) that helps ceftazidime work better.||
1693|021|B|||
1693|022|H|HOW TO USE:  This medication is given by injection into a vein,||
1693|023|H|as directed by your doctor, usually every 8 hours over 2 hours.||
1693|024|H|The dosage and length of treatment are based on your medical||
1693|025|H|condition and response to treatment. Children's dosage is also||
1693|026|H|based on age and weight.||
1693|027|H|   If you are using this medication at home, learn all||
1693|028|H|preparation and usage instructions from your health care||
1693|029|H|professional. Before using, check this product for particles or||
1693|030|H|discoloration. If either is present, do not use the liquid. Learn||
1693|031|H|how to store and discard medical supplies safely.||
1693|032|H|   For the best effect, use this antibiotic at evenly spaced||
1693|033|H|times. To help you remember, use this medication at the same||
1693|034|H|time(s) every day.||
1693|035|H|   Continue to use this medication until the full prescribed||
1693|036|H|amount is finished, even if symptoms disappear after a few days.||
1693|037|H|Stopping the medication too early may result in a return of the||
1693|038|H|infection.||
1693|039|H|   Tell your doctor if your condition lasts or gets worse.||
1693|040|B|||
1693|041|S|SIDE EFFECTS:  Nausea, vomiting, constipation, or anxiety may||
1693|042|S|occur. If any of these effects last or get worse, tell your||
1693|043|S|doctor or pharmacist promptly.||
1693|044|S|   Remember that this medication has been prescribed because your||
1693|045|S|doctor has judged that the benefit to you is greater than the||
1693|046|S|risk of side effects. Many people using this medication do not||
1693|047|S|have serious side effects.||
1693|048|S|   Tell your doctor right away if you have any serious side||
1693|049|S|effects, including: mental/mood changes (such as confusion,||
1693|050|S|hallucinations), seizures, shaking (tremors), muscle spasms,||
1693|051|S|jerking movements, easy bruising/bleeding, yellowing eyes/skin.||
1693|052|S|   This medication may rarely cause a severe intestinal condition||
1693|053|S|due to a bacteria called C. difficile. This condition may occur||
1693|054|S|during treatment or weeks to months after treatment has stopped.||
1693|055|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1693|056|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1693|057|S|stool.||
1693|058|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1693|059|S|products because they may make symptoms worse.||
1693|060|S|   Use of this medication for prolonged or repeated periods may||
1693|061|S|result in oral thrush or a new yeast infection. Contact your||
1693|062|S|doctor if you notice white patches in your mouth, a change in||
1693|063|S|vaginal discharge, or other new symptoms.||
1693|064|S|   A very serious allergic reaction to this drug is rare.||
1693|065|S|However, get medical help right away if you notice any symptoms||
1693|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1693|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1693|068|S|breathing.||
1693|069|S|   This is not a complete list of possible side effects. If you||
1693|070|S|notice other effects not listed above, contact your doctor or||
1693|071|S|pharmacist.||
1693|072|S|   In the US -||
1693|073|S|   Call your doctor for medical advice about side effects. You||
1693|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1693|075|S|www.fda.gov/medwatch.||
1693|076|S|   In Canada - Call your doctor for medical advice about side||
1693|077|S|effects. You may report side effects to Health Canada at||
1693|078|S|1-866-234-2345.||
1693|079|B|||
1693|080|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1693|081|P|pharmacist if you are allergic to ceftazidime or avibactam; or to||
1693|082|P|penicillins, beta-lactam antibiotics, or other cephalosporins; or||
1693|083|P|to other beta-lactamase inhibitors (such as sulbactam); or if you||
1693|084|P|have any other allergies. This product may contain inactive||
1693|085|P|ingredients, which can cause allergic reactions or other||
1693|086|P|problems. Talk to your pharmacist for more details.||
1693|087|P|   Before using this medication, tell your doctor or pharmacist||
1693|088|P|your medical history, especially of: kidney disease.||
1693|089|P|   Ceftazidime/avibactam may cause live bacterial vaccines (such||
1693|090|P|as typhoid vaccine) to not work well. Tell your health care||
1693|091|P|professional that you are using ceftazidime/avibactam before||
1693|092|P|having any immunizations/vaccinations.||
1693|093|P|   Before having surgery, tell your doctor or dentist about all||
1693|094|P|the products you use (including prescription drugs,||
1693|095|P|nonprescription drugs, and herbal products).||
1693|096|P|   During pregnancy, this medication should be used only when||
1693|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
1693|098|P|   Ceftazidime passes into breast milk. It is unknown if||
1693|099|P|avibactam passes into breast milk. Consult your doctor before||
1693|100|P|breastfeeding.||
1693|101|B|||
1693|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1693|103|I|medications work or increase your risk for serious side effects.||
1693|104|I|This document does not contain all possible drug interactions.||
1693|105|I|Keep a list of all the products you use (including||
1693|106|I|prescription/nonprescription drugs and herbal products) and share||
1693|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1693|108|I|the dosage of any medicines without your doctor's approval.||
1693|109|I|   This medication may interfere with certain lab tests (such as||
1693|110|I|Coombs' test, urine glucose tests), possibly causing false test||
1693|111|I|results. Make sure lab personnel and all your doctors know you||
1693|112|I|use this drug.||
1693|113|B|||
1693|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1693|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1693|116|O|poison control center right away. US residents can call||
1693|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1693|118|B|||
1693|119|N|NOTES:  Lab and/or medical tests (such as kidney function) should||
1693|120|N|be done while you are using this medication. Keep all medical and||
1693|121|N|lab appointments. Consult your doctor for more details.||
1693|122|B|||
1693|123|D|MISSED DOSE:  It is important to get each dose of this medication||
1693|124|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1693|125|D|right away for a new dosing schedule. Do not double the dose to||
1693|126|D|catch up.||
1693|127|B|||
1693|128|R|STORAGE:  Consult the product instructions and your pharmacist||
1693|129|R|for storage details. Keep all medications away from children and||
1693|130|R|pets.||
1693|131|R|   Do not flush medications down the toilet or pour them into a||
1693|132|R|drain unless instructed to do so. Properly discard this product||
1693|133|R|when it is expired or no longer needed. Consult your pharmacist||
1693|134|R|or local waste disposal company.||
1693|135|B|||
1693|136|A|Information last revised August 2025.||
1693|137|A|Copyright(c) 2025 First Databank, Inc.||
1693|138|B|||
1694|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1694|002|Z|does NOT have all possible information about this product. This||
1694|003|Z|information does not assure that this product is safe, effective,||
1694|004|Z|or appropriate for you. This information is not individual||
1694|005|Z|medical advice and does not substitute for the advice of your||
1694|006|Z|health care professional. Always ask your health care||
1694|007|Z|professional for complete information about this product and your||
1694|008|Z|specific health needs.||
1694|009|B|||
1694|010|T|DEFERASIROX - ORAL||
1694|011|F|(dee-FER-a-sir-ox)||
1694|012|B|||
1694|013|C|COMMON BRAND NAME(S): Jadenu||
1694|014|B|||
1694|015|W|WARNING:  Deferasirox may rarely cause serious (possibly fatal)||
1694|016|W|kidney disease, liver disease, and stomach/intestinal bleeding||
1694|017|W|(see also Side Effects section). Kidney disease may be more||
1694|018|W|likely to occur in people with kidney problems and in people with||
1694|019|W|serious blood diseases. Liver disease may be more likely to occur||
1694|020|W|in people with liver problems (such as cirrhosis) and in older||
1694|021|W|adults. Stomach/intestinal bleeding may be more likely to occur||
1694|022|W|in older adults with serious blood diseases (including blood||
1694|023|W|cancers). Consult your doctor for more details.||
1694|024|W|   Your doctor will monitor you closely while you are taking this||
1694|025|W|medication. Keep all regular medical and lab appointments.||
1694|026|B|||
1694|027|U|USES:  This medication is used to treat ongoing high levels of||
1694|028|U|iron in the body caused by multiple blood transfusions. It is||
1694|029|U|also used to treat high levels of iron in people with a certain||
1694|030|U|blood disorder who do not require blood transfusions||
1694|031|U|(non-transfusion-dependent thalassemia). It works by binding to||
1694|032|U|iron, allowing the body to pass extra iron out in the stool.||
1694|033|U|Deferasirox belongs to a class of drugs known as iron-chelating||
1694|034|U|agents.||
1694|035|U|   Frequent blood transfusions are often needed in certain types||
1694|036|U|of blood diseases (such as sickle cell disease, anemia). Blood||
1694|037|U|transfusions have very helpful benefits, but they can cause the||
1694|038|U|body to hold on to too much iron. The extra iron can build up in||
1694|039|U|the body and cause problems such as heart failure, liver disease,||
1694|040|U|and diabetes. Getting rid of extra iron can decrease the risk of||
1694|041|U|these diseases.||
1694|042|B|||
1694|043|H|HOW TO USE:  Read the Medication Guide provided by your||
1694|044|H|pharmacist before you start taking deferasirox and each time you||
1694|045|H|get a refill. If you have any questions, ask your doctor or||
1694|046|H|pharmacist.||
1694|047|H|   Take this medication by mouth on an empty stomach or with a||
1694|048|H|light meal (such as a whole-wheat english muffin with jelly and||
1694|049|H|nonfat milk) as directed by your doctor, usually once daily.||
1694|050|H|Avoid taking this medication with a meal high in calories||
1694|051|H|(greater than 250 calories) and fat since it may increase your||
1694|052|H|risk of side effects. Ask your doctor or pharmacist for more||
1694|053|H|details.||
1694|054|H|   Take the tablets with water or other beverages. If you have||
1694|055|H|trouble swallowing the tablets, you may crush the tablets and mix||
1694|056|H|it with soft foods (such as applesauce, yogurt). Swallow all of||
1694|057|H|the drug/food mixture right away. Do not prepare a supply in||
1694|058|H|advance.||
1694|059|H|   If you are using the sprinkle granules, sprinkle the dose on||
1694|060|H|soft food (such as applesauce, yogurt) and take all of it right||
1694|061|H|away.||
1694|062|H|   Antacids that contain aluminum can bind with deferasirox which||
1694|063|H|may affect how deferasirox works. Avoid taking this medication||
1694|064|H|with antacids that contain aluminum.||
1694|065|H|   Use this medication regularly to get the most benefit from it.||
1694|066|H|To help you remember, take it at the same time each day. Do not||
1694|067|H|increase your dose or use this drug more often or for longer than||
1694|068|H|prescribed. Your condition will not improve any faster, and your||
1694|069|H|risk of side effects will increase.||
1694|070|H|   The dosage is based on your medical condition, weight, lab||
1694|071|H|tests, and response to treatment. Your dosage may need to be||
1694|072|H|lowered or your treatment may need to be stopped if you get||
1694|073|H|certain side effects. Follow your doctor's instructions||
1694|074|H|carefully.||
1694|075|B|||
1694|076|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, or dizziness may||
1694|077|S|occur. If any of these effects last or get worse, tell your||
1694|078|S|doctor or pharmacist promptly.||
1694|079|S|   Remember that this medication has been prescribed because your||
1694|080|S|doctor has judged that the benefit to you is greater than the||
1694|081|S|risk of side effects. Many people using this medication do not||
1694|082|S|have serious side effects.||
1694|083|S|   Tell your doctor right away if you have any serious side||
1694|084|S|effects, including: hearing loss, vision changes (such as blurred||
1694|085|S|vision).||
1694|086|S|   This medication decreases bone marrow function, an effect that||
1694|087|S|may lead to a low number of blood cells such as red cells, white||
1694|088|S|cells, and platelets. This effect can worsen anemia, decrease||
1694|089|S|your body's ability to fight an infection, or cause easy||
1694|090|S|bruising/bleeding. Tell your doctor right away if you develop any||
1694|091|S|of the following unlikely symptoms: unusual tiredness, pale skin,||
1694|092|S|signs of infection (such as sore throat that doesn't go away,||
1694|093|S|fever, chills), easy bruising/bleeding.||
1694|094|S|   This drug may rarely cause serious stomach/intestinal problems||
1694|095|S|(such as stomach/intestinal bleeding and ulcers). If you notice||
1694|096|S|any of the following unlikely but serious side effects, stop||
1694|097|S|taking deferasirox and consult your doctor or pharmacist right||
1694|098|S|away: stomach/abdominal pain that doesn't go away, black/bloody||
1694|099|S|stools, vomit that looks like coffee grounds.||
1694|100|S|   Deferasirox may rarely cause serious (possibly fatal) liver||
1694|101|S|disease. Get medical help right away if you have any symptoms of||
1694|102|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1694|103|S|of appetite, stomach/abdominal pain, yellowing of eyes/skin, dark||
1694|104|S|urine.||
1694|105|S|   Deferasirox has rarely caused very serious (possibly fatal)||
1694|106|S|kidney problems. Tell your doctor right away if you develop signs||
1694|107|S|of kidney problems, such as: change in the amount of urine,||
1694|108|S|frothy urine.||
1694|109|S|   Deferasirox can commonly cause a rash that is usually not||
1694|110|S|serious. However, you may not be able to tell it apart from a||
1694|111|S|rare rash that could be a sign of a severe reaction. Get medical||
1694|112|S|help right away if you develop any rash.||
1694|113|S|   A very serious allergic reaction to this drug is rare.||
1694|114|S|However, get medical help right away if you notice any symptoms||
1694|115|S|of a serious allergic reaction, including: rash, itching/swelling||
1694|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1694|117|S|breathing.||
1694|118|S|   This is not a complete list of possible side effects. If you||
1694|119|S|notice other effects not listed above, contact your doctor or||
1694|120|S|pharmacist.||
1694|121|S|   In the US -||
1694|122|S|   Call your doctor for medical advice about side effects. You||
1694|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1694|124|S|www.fda.gov/medwatch.||
1694|125|S|   In Canada - Call your doctor for medical advice about side||
1694|126|S|effects. You may report side effects to Health Canada at||
1694|127|S|1-866-234-2345.||
1694|128|B|||
1694|129|P|PRECAUTIONS:  Before taking deferasirox, tell your doctor or||
1694|130|P|pharmacist if you are allergic to it; or if you have any other||
1694|131|P|allergies. This product may contain inactive ingredients, which||
1694|132|P|can cause allergic reactions or other problems. Talk to your||
1694|133|P|pharmacist for more details.||
1694|134|P|   Before using this medication, tell your doctor or pharmacist||
1694|135|P|your medical history, especially of: kidney disease, liver||
1694|136|P|disease, low platelet counts, advanced cancer, certain bone||
1694|137|P|marrow disorders involving damaged blood-forming cells (high-risk||
1694|138|P|myelodysplastic syndromes).||
1694|139|P|   This drug may make you dizzy or blur your vision. Alcohol or||
1694|140|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
1694|141|P|machinery, or do anything that needs alertness or clear vision||
1694|142|P|until you can do it safely. Limit alcoholic beverages. Talk to||
1694|143|P|your doctor if you are using marijuana (cannabis).||
1694|144|P|   Before having surgery, tell your doctor or dentist about all||
1694|145|P|the products you use (including prescription drugs,||
1694|146|P|nonprescription drugs, and herbal products).||
1694|147|P|   Tell the doctor right away if you develop any illness that may||
1694|148|P|cause dehydration (including fever, diarrhea, or vomiting) or if||
1694|149|P|you are unable to drink fluids. The doctor may need to stop or||
1694|150|P|adjust deferasirox treatment, especially in children.||
1694|151|P|   Children may be more sensitive to the side effects of this||
1694|152|P|drug, especially kidney problems and hearing loss.||
1694|153|P|   Older adults may be more sensitive to the side effects of this||
1694|154|P|drug, especially liver problems, stomach/intestinal bleeding, and||
1694|155|P|ulcers.||
1694|156|P|   Tell your doctor if you are pregnant or plan to become||
1694|157|P|pregnant. You should not become pregnant while using deferasirox.||
1694|158|P|Deferasirox may harm an unborn baby. If you become pregnant, talk||
1694|159|P|to your doctor right away about the risks and benefits of this||
1694|160|P|medication.||
1694|161|P|   It is unknown if this medication passes into breast milk.||
1694|162|P|Because of the possible risk to the infant, breastfeeding is not||
1694|163|P|recommended while using this medication. Consult your doctor||
1694|164|P|before breastfeeding.||
1694|165|B|||
1694|166|I|DRUG INTERACTIONS:  See also How to Use section.||
1694|167|I|   Drug interactions may change how your medications work or||
1694|168|I|increase your risk for serious side effects. This document does||
1694|169|I|not contain all possible drug interactions. Keep a list of all||
1694|170|I|the products you use (including prescription/nonprescription||
1694|171|I|drugs and herbal products) and share it with your doctor and||
1694|172|I|pharmacist. Do not start, stop, or change the dosage of any||
1694|173|I|medicines without your doctor's approval.||
1694|174|I|   Some products that may interact with this drug include:||
1694|175|I|fezolinetant, other drugs that can cause bleeding/bruising||
1694|176|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
1694|177|I|ibuprofen/naproxen, "blood thinners" such as||
1694|178|I|dabigatran/warfarin).||
1694|179|I|   Aspirin can increase the risk of bleeding when used with this||
1694|180|I|medication. However, if your doctor has told you to take low-dose||
1694|181|I|aspirin to prevent heart attack or stroke (usually 81-162||
1694|182|I|milligrams a day), you should keep taking the aspirin unless your||
1694|183|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1694|184|I|details.||
1694|185|I|   This medication can slow down the removal of other medications||
1694|186|I|from your body, which may affect how they work. Examples of||
1694|187|I|affected drugs include tovorafenib, among others.||
1694|188|I|   This medication may decrease the effectiveness of hormonal||
1694|189|I|birth control such as pills, patch, or ring. This could cause||
1694|190|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1694|191|I|use reliable backup birth control methods while using this||
1694|192|I|medication. Also tell your doctor if you have any new spotting or||
1694|193|I|breakthrough bleeding, because these may be signs that your birth||
1694|194|I|control is not working well.||
1694|195|B|||
1694|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1694|197|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1694|198|O|poison control center right away. US residents can call||
1694|199|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1694|200|B|||
1694|201|N|NOTES:  Do not share this medication with others.||
1694|202|N|   Lab and/or medical tests (such as serum ferritin, blood||
1694|203|N|counts, urine tests, liver/kidney function, vision/hearing tests,||
1694|204|N|liver iron concentration) must be done before you start taking||
1694|205|N|this medication and while you are taking it. Keep all medical and||
1694|206|N|lab appointments. Consult your doctor for more details.||
1694|207|B|||
1694|208|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1694|209|D|If it is near the time of the next dose, skip the missed dose.||
1694|210|D|Use your next dose at the regular time. Do not double the dose to||
1694|211|D|catch up.||
1694|212|B|||
1694|213|R|STORAGE:  Store at room temperature away from light and moisture.||
1694|214|R|Do not store in the bathroom. Keep all medications away from||
1694|215|R|children and pets.||
1694|216|R|   Do not flush medications down the toilet or pour them into a||
1694|217|R|drain unless instructed to do so. Properly discard this product||
1694|218|R|when it is expired or no longer needed. Consult your pharmacist||
1694|219|R|or local waste disposal company.||
1694|220|B|||
1694|221|A|Information last revised May 2024.||
1694|222|A|Copyright(c) 2025 First Databank, Inc.||
1694|223|B|||
1695|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1695|002|Z|does NOT have all possible information about this product. This||
1695|003|Z|information does not assure that this product is safe, effective,||
1695|004|Z|or appropriate for you. This information is not individual||
1695|005|Z|medical advice and does not substitute for the advice of your||
1695|006|Z|health care professional. Always ask your health care||
1695|007|Z|professional for complete information about this product and your||
1695|008|Z|specific health needs.||
1695|009|B|||
1695|010|T|LIRAGLUTIDE (WEIGHT LOSS) - INJECTION||
1695|011|F|(LIR-a-GLOO-tide)||
1695|012|B|||
1695|013|C|COMMON BRAND NAME(S): Saxenda||
1695|014|B|||
1695|015|W|WARNING:  This medication has been found to cause a certain type||
1695|016|W|of thyroid tumor (thyroid C-cell tumors) in rats and mice. It is||
1695|017|W|unknown if this medication can cause similar tumors in humans.||
1695|018|W|Talk with your doctor about the benefits and risks of treatment||
1695|019|W|with this medication. This medication should not be used by||
1695|020|W|people with a personal/family history of a certain type of cancer||
1695|021|W|(medullary thyroid carcinoma) or by people with a certain||
1695|022|W|inherited disease (Multiple Endocrine Neoplasia syndrome type 2||
1695|023|W|or MEN 2). While using this medication, tell your doctor right||
1695|024|W|away if you notice any signs or symptoms of thyroid tumors,||
1695|025|W|including unusual growth or lump in the neck, difficulty||
1695|026|W|swallowing, shortness of breath, unusual/lasting hoarseness.||
1695|027|B|||
1695|028|U|USES:  This medication is used with a doctor-approved exercise,||
1695|029|U|behavior change, and reduced-calorie diet program to help you||
1695|030|U|lose weight. It is used by certain overweight people, such as||
1695|031|U|those who are obese or have weight-related medical problems.||
1695|032|U|Losing weight and keeping it off can lessen the many health risks||
1695|033|U|that come with obesity, including heart disease, diabetes, high||
1695|034|U|blood pressure, and a shorter life.||
1695|035|U|   Liraglutide is similar to a natural hormone in your body||
1695|036|U|(incretin). It works by controlling your appetite.||
1695|037|B|||
1695|038|H|HOW TO USE:  Read the Medication Guide and the Instructions for||
1695|039|H|Use Leaflet provided by your pharmacist before you start using||
1695|040|H|liraglutide and each time you get a refill. Ask your health care||
1695|041|H|professional how to prepare and use this medication. If you have||
1695|042|H|questions, ask your doctor or pharmacist.||
1695|043|H|   Inject this medication under the skin as directed by your||
1695|044|H|doctor, usually once daily. The injection is given in the thigh,||
1695|045|H|abdomen, or upper arm. Your doctor will start you on a low dose||
1695|046|H|first to decrease your risk of stomach/abdominal side effects,||
1695|047|H|and gradually increase your dose. If more than 3 days have passed||
1695|048|H|since your last liraglutide dose, ask your doctor if you should||
1695|049|H|restart the medication with the low dose to reduce your chance of||
1695|050|H|side effects. Follow your doctor's instructions carefully.||
1695|051|H|   Before using, check this product for particles or||
1695|052|H|discoloration. If either is present, do not use the liquid.||
1695|053|H|Before injecting each dose, clean the skin you are going to||
1695|054|H|inject into (the injection site) with rubbing alcohol. Change the||
1695|055|H|injection site each time to lessen injury under the skin. To||
1695|056|H|lessen bruising, do not rub the injection site after a shot.||
1695|057|H|Learn how to store and discard medical supplies safely.||
1695|058|H|   Use this medication regularly to get the most benefit from it.||
1695|059|H|To help you remember, use it at the same time each day. Carefully||
1695|060|H|follow the meal plan and exercise program your doctor has||
1695|061|H|recommended.||
1695|062|H|   Do not share your pen device with another person, even if the||
1695|063|H|needle is changed. You may give other people a serious infection,||
1695|064|H|or get a serious infection from them.||
1695|065|B|||
1695|066|S|SIDE EFFECTS:  See also Warning section.||
1695|067|S|   Nausea, vomiting, stomach upset, diarrhea, gas, heartburn, or||
1695|068|S|constipation may occur. Nausea usually lessens as you continue to||
1695|069|S|use liraglutide. If any of these effects last or get worse, tell||
1695|070|S|your doctor or pharmacist promptly.||
1695|071|S|   Remember that this medication has been prescribed because your||
1695|072|S|doctor has judged that the benefit to you is greater than the||
1695|073|S|risk of side effects. Many people using this medication do not||
1695|074|S|have serious side effects.||
1695|075|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
1695|076|S|Contact your doctor promptly if you notice any symptoms of||
1695|077|S|dehydration, such as unusual dry mouth/thirst or||
1695|078|S|dizziness/lightheadedness.||
1695|079|S|   Tell your doctor right away if you have any serious side||
1695|080|S|effects, including: signs of kidney problems (such as change in||
1695|081|S|the amount of urine), yellowing eyes/skin, fast heartbeat,||
1695|082|S|mental/mood changes (such as depression, thoughts of suicide),||
1695|083|S|signs of low blood sugar (sudden sweating, shaking, fast||
1695|084|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1695|085|S|hands/feet).||
1695|086|S|   Get medical help right away if you have any very serious side||
1695|087|S|effects, including: signs of pancreas or gallbladder disease||
1695|088|S|(such as nausea/vomiting that doesn't stop, severe||
1695|089|S|stomach/abdominal pain).||
1695|090|S|   A very serious allergic reaction to this drug is rare.||
1695|091|S|However, get medical help right away if you notice any symptoms||
1695|092|S|of a serious allergic reaction, including: rash, itching/swelling||
1695|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1695|094|S|breathing.||
1695|095|S|   This is not a complete list of possible side effects. If you||
1695|096|S|notice other effects not listed above, contact your doctor or||
1695|097|S|pharmacist.||
1695|098|S|   In the US -||
1695|099|S|   Call your doctor for medical advice about side effects. You||
1695|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1695|101|S|www.fda.gov/medwatch.||
1695|102|S|   In Canada - Call your doctor for medical advice about side||
1695|103|S|effects. You may report side effects to Health Canada at||
1695|104|S|1-866-234-2345.||
1695|105|B|||
1695|106|P|PRECAUTIONS:  See also Warning section.||
1695|107|P|   Before using liraglutide, tell your doctor or pharmacist if||
1695|108|P|you are allergic to it; or if you have any other allergies. This||
1695|109|P|product may contain inactive ingredients, which can cause||
1695|110|P|allergic reactions or other problems. Talk to your pharmacist for||
1695|111|P|more details.||
1695|112|P|   Before using this medication, tell your doctor or pharmacist||
1695|113|P|your medical history, especially of: kidney disease, disease of||
1695|114|P|the pancreas (pancreatitis), gallbladder disease, mental/mood||
1695|115|P|disorders (such as depression, thoughts of suicide), certain||
1695|116|P|stomach/intestinal disorders (gastroparesis, problems digesting||
1695|117|P|food).||
1695|118|P|   Before having surgery, tell your doctor or dentist about all||
1695|119|P|the products you use (including prescription drugs,||
1695|120|P|nonprescription drugs, and herbal products).||
1695|121|P|   If you have diabetes, this product may affect your blood||
1695|122|P|sugar. Check your blood sugar regularly as directed and share the||
1695|123|P|results with your doctor. Tell your doctor right away if you have||
1695|124|P|symptoms of low blood sugar (see Side Effects section). Your||
1695|125|P|doctor may need to adjust your diabetes medication(s), exercise||
1695|126|P|program, or diet.||
1695|127|P|   This medication must not be used during pregnancy. It may harm||
1695|128|P|an unborn baby. If you become pregnant or think you may be||
1695|129|P|pregnant, tell your doctor right away.||
1695|130|P|   It is unknown if this medication passes into breast milk.||
1695|131|P|Consult your doctor before breastfeeding.||
1695|132|B|||
1695|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1695|134|I|medications work or increase your risk for serious side effects.||
1695|135|I|This document does not contain all possible drug interactions.||
1695|136|I|Keep a list of all the products you use (including||
1695|137|I|prescription/nonprescription drugs and herbal products) and share||
1695|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
1695|139|I|the dosage of any medicines without your doctor's approval.||
1695|140|I|   Some products that may interact with this drug include:||
1695|141|I|diabetes medications (such as insulin, sulfonylureas including||
1695|142|I|glyburide).||
1695|143|I|   Do not use this medication with any other product that||
1695|144|I|contains liraglutide or other medications which are similar to||
1695|145|I|this medication, but used for diabetes (such as exenatide,||
1695|146|I|dulaglutide).||
1695|147|B|||
1695|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1695|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1695|150|O|poison control center right away. US residents can call||
1695|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1695|152|O|Symptoms of overdose may include: severe nausea/vomiting.||
1695|153|B|||
1695|154|N|NOTES:  Do not share this medication with others.||
1695|155|N|   Lab and/or medical tests (such as kidney function, fasting||
1695|156|N|blood glucose, heartbeat, weight) should be done while you are||
1695|157|N|using this medication. Keep all medical and lab appointments.||
1695|158|N|Consult your doctor for more details.||
1695|159|B|||
1695|160|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1695|161|D|If it is near the time of the next dose, skip the missed dose.||
1695|162|D|Use your next dose at the regular time. Do not double the dose to||
1695|163|D|catch up.||
1695|164|B|||
1695|165|R|STORAGE:  Before using the liraglutide pen for the first time,||
1695|166|R|store it in the refrigerator. Do not freeze. After first use,||
1695|167|R|liraglutide can be stored at room temperature or in the||
1695|168|R|refrigerator. Protect from heat and sunlight. Discard 30 days||
1695|169|R|after first use, even if some drug remains in the pen. Keep all||
1695|170|R|medications away from children and pets.||
1695|171|R|   Do not flush medications down the toilet or pour them into a||
1695|172|R|drain unless instructed to do so. Properly discard this product||
1695|173|R|when it is expired or no longer needed. Consult your pharmacist||
1695|174|R|or local waste disposal company.||
1695|175|B|||
1695|176|A|Information last revised September 2024.||
1695|177|A|Copyright(c) 2025 First Databank, Inc.||
1695|178|B|||
1697|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1697|002|Z|does NOT have all possible information about this product. This||
1697|003|Z|information does not assure that this product is safe, effective,||
1697|004|Z|or appropriate for you. This information is not individual||
1697|005|Z|medical advice and does not substitute for the advice of your||
1697|006|Z|health care professional. Always ask your health care||
1697|007|Z|professional for complete information about this product and your||
1697|008|Z|specific health needs.||
1697|009|B|||
1697|010|T|ALBUTEROL (SALBUTAMOL) BREATH-ACTIVATED INHALER - ORAL INHALATION||
1697|011|F|(al-BUE-ter-ol/sal-BUE-ta-mol)||
1697|012|B|||
1697|013|C|COMMON BRAND NAME(S): ProAir RespiClick||
1697|014|B|||
1697|015|U|USES:  Albuterol (also known as salbutamol) is used to prevent||
1697|016|U|and treat wheezing and shortness of breath caused by breathing||
1697|017|U|problems (such as asthma, chronic obstructive pulmonary disease).||
1697|018|U|It is also used to prevent asthma brought on by exercise. It is a||
1697|019|U|quick-relief medication. Albuterol belongs to a class of drugs||
1697|020|U|known as bronchodilators. It works by relaxing the muscles around||
1697|021|U|the airways so that they open up and you can breathe more easily.||
1697|022|U|Controlling symptoms of breathing problems can decrease time lost||
1697|023|U|from work or school.||
1697|024|B|||
1697|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
1697|026|H|Instructions for Use provided by your pharmacist before you start||
1697|027|H|using this medication and each time you get a refill. Follow the||
1697|028|H|illustrated directions for the proper use of this medication. If||
1697|029|H|you have any questions, ask your doctor or pharmacist.||
1697|030|H|   Some brands of this inhaler have a built-in sensor that can||
1697|031|H|store data on its use. This information can be used with a||
1697|032|H|smartphone application (app). Read the manufacturer's information||
1697|033|H|on how to set up and use the app. You do not have to use the app||
1697|034|H|in order for the inhaler to work. You can review the data and||
1697|035|H|share it with your health care provider if you want to.||
1697|036|H|   Inhale this medication by mouth as directed by your doctor,||
1697|037|H|usually every 4 to 6 hours as needed. The dosage is based on your||
1697|038|H|medical condition and response to treatment. Do not increase your||
1697|039|H|dose or use this drug more often than prescribed without your||
1697|040|H|doctor's approval. Using too much of this medication will||
1697|041|H|increase your risk of serious (possibly fatal) side effects.||
1697|042|H|   If you are using this medication to prevent asthma brought on||
1697|043|H|by exercise, use it 15 to 30 minutes before exercise.||
1697|044|H|   Do not use a spacer with this inhaler and do not open the cap||
1697|045|H|unless you are ready to take a dose.||
1697|046|H|   Before use, hold the inhaler upright and open the cap. You||
1697|047|H|should hear a click, which means the inhaler is ready for use.||
1697|048|H|Place the mouthpiece near your mouth and breathe out as far as is||
1697|049|H|comfortable. Do not breathe into the inhaler device. Then put the||
1697|050|H|mouthpiece in your mouth, close your lips around it, and breathe||
1697|051|H|in steadily and deeply. Hold your breath for about 10 seconds, or||
1697|052|H|for as long as is comfortable. Close the cap after each use.||
1697|053|H|   Clean the outside of the mouthpiece with a dry tissue or cloth||
1697|054|H|as needed. Do not use water or any other liquid for cleaning. If||
1697|055|H|liquid gets into the inhaler, it may not work properly. Replace||
1697|056|H|the inhaler if it has been washed or placed in water.||
1697|057|H|   If a child is using this medication, a parent or other||
1697|058|H|responsible adult may need to help the child use the inhaler||
1697|059|H|properly.||
1697|060|H|   If you are using other inhalers at the same time, wait at||
1697|061|H|least 1 minute between the use of each medication.||
1697|062|H|   Always have this quick-relief inhaler with you. Keep track of||
1697|063|H|the number of inhalations used from each device. Discard the||
1697|064|H|device after you have used the number of inhalations marked on||
1697|065|H|the manufacturer's package.||
1697|066|H|   Learn which of your inhalers you should use every day||
1697|067|H|(controller drugs) and which you should use if your breathing||
1697|068|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
1697|069|H|time what you should do if you have new or worsening cough or||
1697|070|H|shortness of breath, wheezing, increased sputum, worsening peak||
1697|071|H|flow meter readings, waking up at night with trouble breathing,||
1697|072|H|if you use your quick-relief inhaler more often (more than 2 days||
1697|073|H|a week), or if your quick-relief inhaler does not seem to be||
1697|074|H|working well. Learn when you can treat sudden breathing problems||
1697|075|H|by yourself and when you must get medical help right away.||
1697|076|H|   Tell your doctor if your symptoms do not get better or if they||
1697|077|H|get worse.||
1697|078|B|||
1697|079|S|SIDE EFFECTS:  Nervousness, dizziness, shaking (tremor),||
1697|080|S|headache, nausea, mouth/throat dryness or irritation, or unusual||
1697|081|S|taste may occur. If any of these effects last or get worse, tell||
1697|082|S|your doctor or pharmacist promptly.||
1697|083|S|   This medication may raise your blood pressure. Check your||
1697|084|S|blood pressure regularly and tell your doctor if the results are||
1697|085|S|high.||
1697|086|S|   Remember that this medication has been prescribed because your||
1697|087|S|doctor has judged that the benefit to you is greater than the||
1697|088|S|risk of side effects. Many people using this medication do not||
1697|089|S|have serious side effects.||
1697|090|S|   Tell your doctor right away if you have any serious side||
1697|091|S|effects, including: fast/pounding heartbeat.||
1697|092|S|   Get medical help right away if you have any very serious side||
1697|093|S|effects, including: chest pain, irregular heartbeat, rapid||
1697|094|S|breathing, confusion.||
1697|095|S|   Rarely, this medication has caused severe (rarely fatal),||
1697|096|S|sudden worsening of breathing problems/asthma (paradoxical||
1697|097|S|bronchospasm). If you experience sudden wheezing, get medical||
1697|098|S|help right away.||
1697|099|S|   A very serious allergic reaction to this drug is rare.||
1697|100|S|However, get medical help right away if you notice any symptoms||
1697|101|S|of a serious allergic reaction, including: rash, itching/swelling||
1697|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1697|103|S|breathing.||
1697|104|S|   This is not a complete list of possible side effects. If you||
1697|105|S|notice other effects not listed above, contact your doctor or||
1697|106|S|pharmacist.||
1697|107|S|   In the US -||
1697|108|S|   Call your doctor for medical advice about side effects. You||
1697|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1697|110|S|www.fda.gov/medwatch.||
1697|111|S|   In Canada - Call your doctor for medical advice about side||
1697|112|S|effects. You may report side effects to Health Canada at||
1697|113|S|1-866-234-2345.||
1697|114|B|||
1697|115|P|PRECAUTIONS:  Before using albuterol, tell your doctor or||
1697|116|P|pharmacist if you are allergic to it; or to similar drugs (such||
1697|117|P|as levalbuterol, metaproterenol, salmeterol); or if you have any||
1697|118|P|other allergies. This product may contain inactive ingredients||
1697|119|P|(such as lactose, milk proteins), which can cause allergic||
1697|120|P|reactions or other problems. Talk to your pharmacist for more||
1697|121|P|details.||
1697|122|P|   Before using this medication, tell your doctor or pharmacist||
1697|123|P|your medical history, especially of: heart problems (such as||
1697|124|P|irregular heartbeat, angina, previous heart attack), high blood||
1697|125|P|pressure, seizure.||
1697|126|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1697|127|P|can make you more dizzy. Do not drive, use machinery, or do||
1697|128|P|anything that needs alertness until you can do it safely. Limit||
1697|129|P|alcoholic beverages. Talk to your doctor if you are using||
1697|130|P|marijuana (cannabis).||
1697|131|P|   Before having surgery, tell your doctor or dentist about all||
1697|132|P|the products you use (including prescription drugs,||
1697|133|P|nonprescription drugs, and herbal products).||
1697|134|P|   During pregnancy, this medication should be used only when||
1697|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
1697|136|P|   It is unknown if this drug passes into breast milk. Consult||
1697|137|P|your doctor before breastfeeding.||
1697|138|B|||
1697|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1697|140|I|medications work or increase your risk for serious side effects.||
1697|141|I|This document does not contain all possible drug interactions.||
1697|142|I|Keep a list of all the products you use (including||
1697|143|I|prescription/nonprescription drugs and herbal products) and share||
1697|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
1697|145|I|the dosage of any medicines without your doctor's approval.||
1697|146|I|   Albuterol is very similar to levalbuterol. Do not use||
1697|147|I|medications containing levalbuterol while using albuterol.||
1697|148|B|||
1697|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1697|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1697|151|O|poison control center right away. US residents can call||
1697|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1697|153|O|Symptoms of overdose may include: chest pain,||
1697|154|O|fast/pounding/irregular heartbeat, seizures.||
1697|155|B|||
1697|156|N|NOTES:  Do not share this medication with others.||
1697|157|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
1697|158|N|EKG) may be done while you are using this medication. Keep all||
1697|159|N|medical and lab appointments. Consult your doctor for more||
1697|160|N|details.||
1697|161|N|   Avoid substances that can worsen breathing problems by causing||
1697|162|N|irritation or allergic reaction, such as smoke, pollen, pet||
1697|163|N|dander, dust, and mold.||
1697|164|N|   Learn to use a peak flow meter, use it daily, and promptly||
1697|165|N|report worsening breathing problems (such as readings in the||
1697|166|N|yellow/red range, increased use of quick-relief inhalers).||
1697|167|N|   Because the flu virus can worsen breathing problems, ask your||
1697|168|N|doctor or pharmacist if you should have a flu shot every year.||
1697|169|B|||
1697|170|D|MISSED DOSE:  If you are using albuterol regularly and miss a||
1697|171|D|dose, use it as soon as you remember. If it is near the time of||
1697|172|D|the next dose, skip the missed dose. Use your next dose at the||
1697|173|D|regular time. Do not double the dose to catch up.||
1697|174|B|||
1697|175|R|STORAGE:  Store at room temperature away from moisture. Do not||
1697|176|R|store in the bathroom. Keep all medications away from children||
1697|177|R|and pets.||
1697|178|R|   Keep the inhaler in the foil pouch until ready for use. Once||
1697|179|R|removed from the pouch, throw away the inhaler after 13 months||
1697|180|R|even if there is still medication left.||
1697|181|R|   Do not flush medications down the toilet or pour them into a||
1697|182|R|drain unless instructed to do so. Properly discard this product||
1697|183|R|when it is expired or no longer needed. Consult your pharmacist||
1697|184|R|or local waste disposal company.||
1697|185|B|||
1697|186|M|MEDICAL ALERT:  Your condition can cause complications in a||
1697|187|M|medical emergency. For information about enrolling in MedicAlert,||
1697|188|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1697|189|B|||
1697|190|A|Information last revised July 2025.||
1697|191|A|Copyright(c) 2025 First Databank, Inc.||
1697|192|B|||
1698|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1698|002|Z|does NOT have all possible information about this product. This||
1698|003|Z|information does not assure that this product is safe, effective,||
1698|004|Z|or appropriate for you. This information is not individual||
1698|005|Z|medical advice and does not substitute for the advice of your||
1698|006|Z|health care professional. Always ask your health care||
1698|007|Z|professional for complete information about this product and your||
1698|008|Z|specific health needs.||
1698|009|B|||
1698|010|T|MEMANTINE/DONEPEZIL - ORAL||
1698|011|F|(MEM-an-teen/doe-NEP-e-zil)||
1698|012|B|||
1698|013|C|COMMON BRAND NAME(S): Namzaric||
1698|014|B|||
1698|015|U|USES:  This combination medication is used to treat moderate to||
1698|016|U|severe confusion (dementia) related to Alzheimer's disease. It||
1698|017|U|does not cure Alzheimer's disease, but it may improve memory,||
1698|018|U|awareness, and the ability to perform daily functions. This||
1698|019|U|product contains 2 medications. Memantine works by blocking the||
1698|020|U|action of a certain natural substance in the brain (glutamate)||
1698|021|U|that is believed to be linked to symptoms of Alzheimer's disease.||
1698|022|U|Donepezil is an enzyme blocker that works by restoring the||
1698|023|U|balance of natural substances (neurotransmitters) in the brain.||
1698|024|B|||
1698|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1698|026|H|from your pharmacist before you start taking this product and||
1698|027|H|each time you get a refill. If you have any questions, ask your||
1698|028|H|doctor or pharmacist.||
1698|029|H|   Take this medication by mouth with or without food as directed||
1698|030|H|by your doctor, usually once daily just before bedtime.||
1698|031|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
1698|032|H|Doing so can release all of the drug at once, increasing the risk||
1698|033|H|of side effects. If you have trouble swallowing the capsules||
1698|034|H|whole, the capsule may be opened and the contents may be||
1698|035|H|sprinkled on applesauce. Swallow all of the drug/food mixture||
1698|036|H|right away without chewing. Do not prepare a supply in advance.||
1698|037|H|   To reduce your risk of side effects, your doctor may direct||
1698|038|H|you to start this medication at a low dose and gradually increase||
1698|039|H|your dose. Follow your doctor's instructions carefully.||
1698|040|H|   The dosage is based on your medical condition and response to||
1698|041|H|treatment.||
1698|042|H|   Use this medication regularly to get the most benefit from it.||
1698|043|H|To help you remember, take it at the same time each day. Do not||
1698|044|H|increase your dose or use this drug more often than prescribed.||
1698|045|H|   Tell your doctor if your condition gets worse.||
1698|046|B|||
1698|047|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, loss of appetite,||
1698|048|S|increased weight, loss of bladder control, back pain, headache,||
1698|049|S|bruising, drowsiness, or dizziness may occur. If any of these||
1698|050|S|effects last or get worse, tell your doctor or pharmacist||
1698|051|S|promptly.||
1698|052|S|   Remember that this medication has been prescribed because your||
1698|053|S|doctor has judged that the benefit to you is greater than the||
1698|054|S|risk of side effects. Many people using this medication do not||
1698|055|S|have serious side effects.||
1698|056|S|   Tell your doctor right away if you have any serious side||
1698|057|S|effects, including: signs of stomach/intestinal bleeding (such as||
1698|058|S|black/bloody stools, vomit that contains blood or looks like||
1698|059|S|coffee grounds, stomach/abdominal pain), difficulty urinating,||
1698|060|S|mental/mood changes (such as depression, aggression).||
1698|061|S|   Get medical help right away if you have any very serious side||
1698|062|S|effects, including: fast/slow/irregular heartbeat, severe||
1698|063|S|dizziness, fainting, seizures.||
1698|064|S|   A very serious allergic reaction to this drug is rare.||
1698|065|S|However, get medical help right away if you notice any symptoms||
1698|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1698|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1698|068|S|breathing.||
1698|069|S|   This is not a complete list of possible side effects. If you||
1698|070|S|notice other effects not listed above, contact your doctor or||
1698|071|S|pharmacist.||
1698|072|S|   In the US -||
1698|073|S|   Call your doctor for medical advice about side effects. You||
1698|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1698|075|S|www.fda.gov/medwatch.||
1698|076|S|   In Canada - Call your doctor for medical advice about side||
1698|077|S|effects. You may report side effects to Health Canada at||
1698|078|S|1-866-234-2345.||
1698|079|B|||
1698|080|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1698|081|P|pharmacist if you are allergic to memantine; or to donepezil; or||
1698|082|P|if you have any other allergies. This product may contain||
1698|083|P|inactive ingredients, which can cause allergic reactions or other||
1698|084|P|problems. Talk to your pharmacist for more details.||
1698|085|P|   Before using this medication, tell your doctor or pharmacist||
1698|086|P|your medical history, especially of: kidney problems, severe||
1698|087|P|urinary tract infections, recent dietary change (from a||
1698|088|P|high-protein diet to a vegetarian diet), stomach/intestinal||
1698|089|P|disease (such as bleeding, ulcers), difficulty urinating (such as||
1698|090|P|due to enlarged prostate), seizures, breathing problems (such as||
1698|091|P|asthma, chronic obstructive pulmonary disease-COPD).||
1698|092|P|   Donepezil may cause a condition that affects the heart rhythm||
1698|093|P|(QT prolongation). QT prolongation can rarely cause serious||
1698|094|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1698|095|P|as severe dizziness, fainting) that need medical attention right||
1698|096|P|away.||
1698|097|P|   The risk of QT prolongation may be increased if you have||
1698|098|P|certain medical conditions or are taking other drugs that may||
1698|099|P|cause QT prolongation. Before using this product, tell your||
1698|100|P|doctor or pharmacist of all the drugs you take and if you have||
1698|101|P|any of the following conditions: certain heart problems (heart||
1698|102|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1698|103|P|history of certain heart problems (QT prolongation in the EKG,||
1698|104|P|sudden cardiac death).||
1698|105|P|   Low levels of potassium or magnesium in the blood may also||
1698|106|P|increase your risk of QT prolongation. This risk may increase if||
1698|107|P|you use certain drugs (such as diuretics/"water pills") or if you||
1698|108|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1698|109|P|Talk to your doctor about using this product safely.||
1698|110|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1698|111|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1698|112|P|machinery, or do anything that needs alertness until you can do||
1698|113|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1698|114|P|are using marijuana (cannabis).||
1698|115|P|   Before having surgery, tell your doctor or dentist about all||
1698|116|P|the products you use (including prescription drugs,||
1698|117|P|nonprescription drugs, and herbal products).||
1698|118|P|   Older adults may be more sensitive to the side effects of this||
1698|119|P|drug, especially QT prolongation (see above).||
1698|120|P|   During pregnancy, this product should be used only when||
1698|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
1698|122|P|   It is unknown if this product passes into breast milk. Consult||
1698|123|P|your doctor before breastfeeding.||
1698|124|B|||
1698|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1698|126|I|medications work or increase your risk for serious side effects.||
1698|127|I|This document does not contain all possible drug interactions.||
1698|128|I|Keep a list of all the products you use (including||
1698|129|I|prescription/nonprescription drugs and herbal products) and share||
1698|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
1698|131|I|the dosage of any medicines without your doctor's approval.||
1698|132|I|   Some products that may interact with this drug include:||
1698|133|I|carbonic anhydrase inhibitors (such as acetazolamide,||
1698|134|I|methazolamide), sodium bicarbonate, aspirin/non-steroidal||
1698|135|I|anti-inflammatory drugs (NSAIDs, such as ibuprofen, naproxen).||
1698|136|I|   Check all prescription and nonprescription medicine labels||
1698|137|I|carefully since many medications contain pain relievers/fever||
1698|138|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen) that if||
1698|139|I|taken together with donepezil may increase your risk for||
1698|140|I|stomach/intestinal bleeding. However, if your doctor has told you||
1698|141|I|to take low-dose aspirin to prevent heart attack or stroke||
1698|142|I|(usually 81-162 milligrams a day), you should keep taking the||
1698|143|I|aspirin unless your doctor tells you not to. Ask your doctor or||
1698|144|I|pharmacist for more details.||
1698|145|B|||
1698|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1698|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1698|148|O|poison control center right away. US residents can call||
1698|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1698|150|O|Symptoms of overdose may include: nausea/vomiting that is severe||
1698|151|O|and does not stop, excessive sweating, very slow heartbeat, slow||
1698|152|O|or shallow breathing, seizures, restlessness, hallucinations,||
1698|153|O|loss of consciousness.||
1698|154|B|||
1698|155|N|NOTES:  Do not share this medication with others.||
1698|156|B|||
1698|157|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1698|158|D|next dose at the regular time. Do not double the dose to catch||
1698|159|D|up.||
1698|160|B|||
1698|161|R|STORAGE:  Store at room temperature away from light and moisture.||
1698|162|R|Do not store in the bathroom. Keep all medications away from||
1698|163|R|children and pets.||
1698|164|R|   Do not flush medications down the toilet or pour them into a||
1698|165|R|drain unless instructed to do so. Properly discard this product||
1698|166|R|when it is expired or no longer needed. Consult your pharmacist||
1698|167|R|or local waste disposal company.||
1698|168|B|||
1698|169|A|Information last revised November 2024.||
1698|170|A|Copyright(c) 2025 First Databank, Inc.||
1698|171|B|||
1699|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1699|002|Z|does NOT have all possible information about this product. This||
1699|003|Z|information does not assure that this product is safe, effective,||
1699|004|Z|or appropriate for you. This information is not individual||
1699|005|Z|medical advice and does not substitute for the advice of your||
1699|006|Z|health care professional. Always ask your health care||
1699|007|Z|professional for complete information about this product and your||
1699|008|Z|specific health needs.||
1699|009|B|||
1699|010|T|LEVOLEUCOVORIN - INJECTION||
1699|011|F|(LEE-voe-LOO-koe-VOR-in)||
1699|012|B|||
1699|013|C|COMMON BRAND NAME(S): Fusilev, Khapzory||
1699|014|B|||
1699|015|U|USES:  This medication is used to treat or prevent serious blood||
1699|016|U|cell disorders (such as thrombocytopenia, neutropenia, anemia)||
1699|017|U|caused by certain drugs (folic acid antagonists such as||
1699|018|U|methotrexate, trimethoprim, pyrimethamine). Some brands may also||
1699|019|U|be used with a certain cancer drug (5-fluorouracil) to treat||
1699|020|U|patients with colon cancer.||
1699|021|B|||
1699|022|H|HOW TO USE:  This medication is given by injection into a vein as||
1699|023|H|directed by your doctor, usually every 3 or 6 hours. For the||
1699|024|H|treatment of colon cancer, it is usually given once daily. Do not||
1699|025|H|inject this medication into the spine. The dosage is based on||
1699|026|H|your medical condition, body size, and response to treatment.||
1699|027|H|   If you are using this medication at home, learn all||
1699|028|H|preparation and usage instructions from your health care||
1699|029|H|professional and the product package. Before using, check this||
1699|030|H|product for particles or discoloration. If either is present, do||
1699|031|H|not use the liquid. Learn how to store and discard medical||
1699|032|H|supplies safely.||
1699|033|H|   Use this medication regularly to get the most benefit from it.||
1699|034|H|To help you remember, use it at the same time(s) each day.||
1699|035|B|||
1699|036|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, or mouth sores may||
1699|037|S|occur. If any of these effects last or get worse, tell your||
1699|038|S|doctor or pharmacist promptly.||
1699|039|S|   Remember that this medication has been prescribed because your||
1699|040|S|doctor has judged that the benefit to you is greater than the||
1699|041|S|risk of side effects. Many people using this medication do not||
1699|042|S|have serious side effects.||
1699|043|S|   A very serious allergic reaction to this drug is rare.||
1699|044|S|However, get medical help right away if you notice any symptoms||
1699|045|S|of a serious allergic reaction, including: rash, itching/swelling||
1699|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1699|047|S|breathing.||
1699|048|S|   This is not a complete list of possible side effects. If you||
1699|049|S|notice other effects not listed above, contact your doctor or||
1699|050|S|pharmacist.||
1699|051|S|   In the US -||
1699|052|S|   Call your doctor for medical advice about side effects. You||
1699|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1699|054|S|www.fda.gov/medwatch.||
1699|055|S|   In Canada - Call your doctor for medical advice about side||
1699|056|S|effects. You may report side effects to Health Canada at||
1699|057|S|1-866-234-2345.||
1699|058|B|||
1699|059|P|PRECAUTIONS:  Before using levoleucovorin, tell your doctor or||
1699|060|P|pharmacist if you are allergic to it; or to leucovorin; or to||
1699|061|P|folic acid or folinic acid; or if you have any other allergies.||
1699|062|P|This product may contain inactive ingredients, which can cause||
1699|063|P|allergic reactions or other problems. Talk to your pharmacist for||
1699|064|P|more details.||
1699|065|P|   Before using this medication, tell your doctor or pharmacist||
1699|066|P|your medical history, especially of: certain anemias (due to||
1699|067|P|vitamin B12 deficiency).||
1699|068|P|   Before having surgery, tell your doctor or dentist about all||
1699|069|P|the products you use (including prescription drugs,||
1699|070|P|nonprescription drugs, and herbal products).||
1699|071|P|   During pregnancy, this medication should be used only when||
1699|072|P|clearly needed. Discuss the risks and benefits with your doctor.||
1699|073|P|   It is unknown if this medication passes into breast milk.||
1699|074|P|Consult your doctor before breastfeeding.||
1699|075|B|||
1699|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1699|077|I|medications work or increase your risk for serious side effects.||
1699|078|I|This document does not contain all possible drug interactions.||
1699|079|I|Keep a list of all the products you use (including||
1699|080|I|prescription/nonprescription drugs and herbal products) and share||
1699|081|I|it with your doctor and pharmacist. Do not start, stop, or change||
1699|082|I|the dosage of any medicines without your doctor's approval.||
1699|083|I|   Levoleucovorin is very similar to leucovorin. Do not use||
1699|084|I|medications containing leucovorin while using levoleucovorin.||
1699|085|B|||
1699|086|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1699|087|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1699|088|O|poison control center right away. US residents can call||
1699|089|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1699|090|B|||
1699|091|N|NOTES:  Do not share this medication with others.||
1699|092|N|   Lab and/or medical tests (such as kidney function, complete||
1699|093|N|blood count, folic acid antagonist blood levels) should be done||
1699|094|N|while you are using this medication. Keep all medical and lab||
1699|095|N|appointments. Consult your doctor for more details.||
1699|096|B|||
1699|097|D|MISSED DOSE:  It is important to get each dose of this medication||
1699|098|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1699|099|D|right away for a new dosing schedule. Do not double the dose to||
1699|100|D|catch up.||
1699|101|B|||
1699|102|R|STORAGE:  Different brands of this medication have different||
1699|103|R|storage needs. Check the product package for instructions on how||
1699|104|R|to store your brand, or ask your pharmacist. Keep all medications||
1699|105|R|away from children and pets.||
1699|106|R|   Do not flush medications down the toilet or pour them into a||
1699|107|R|drain unless instructed to do so. Properly discard this product||
1699|108|R|when it is expired or no longer needed. Consult your pharmacist||
1699|109|R|or local waste disposal company.||
1699|110|B|||
1699|111|A|Information last revised November 2024.||
1699|112|A|Copyright(c) 2025 First Databank, Inc.||
1699|113|B|||
1700|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1700|002|Z|does NOT have all possible information about this product. This||
1700|003|Z|information does not assure that this product is safe, effective,||
1700|004|Z|or appropriate for you. This information is not individual||
1700|005|Z|medical advice and does not substitute for the advice of your||
1700|006|Z|health care professional. Always ask your health care||
1700|007|Z|professional for complete information about this product and your||
1700|008|Z|specific health needs.||
1700|009|B|||
1700|010|T|IVABRADINE - ORAL||
1700|011|F|(eye-VAB-ra-deen)||
1700|012|B|||
1700|013|C|COMMON BRAND NAME(S): Corlanor||
1700|014|B|||
1700|015|U|USES:  This medication is used to treat heart failure. It is used||
1700|016|U|by adults to help prevent the heart failure from getting worse||
1700|017|U|and needing treatment in a hospital. It is also used by children||
1700|018|U|who have heart failure due to an enlarged heart (dilated||
1700|019|U|cardiomyopathy). Heart failure is a condition where your heart||
1700|020|U|does not pump blood as well as it should. Ivabradine works by||
1700|021|U|making your heart beat more slowly.||
1700|022|B|||
1700|023|V|OTHER USES:  This section contains uses of this drug that are not||
1700|024|V|listed in the approved professional labeling for the drug but||
1700|025|V|that may be prescribed by your health care professional. Use this||
1700|026|V|drug for a condition that is listed in this section only if it||
1700|027|V|has been so prescribed by your health care professional.||
1700|028|V|   This drug may also be used for fast heartbeat.||
1700|029|B|||
1700|030|H|HOW TO USE:  Read the Medication Guide provided by your||
1700|031|H|pharmacist before you start taking ivabradine and each time you||
1700|032|H|get a refill. If you have any questions, ask your doctor or||
1700|033|H|pharmacist.||
1700|034|H|   Take this medication by mouth with food as directed by your||
1700|035|H|doctor, usually twice daily. The dosage is based on your medical||
1700|036|H|condition and response to treatment. Children's dosage is also||
1700|037|H|based on weight. To reduce your risk of side effects, your doctor||
1700|038|H|may direct you to start this medication at a low dose and||
1700|039|H|gradually increase your dose. Other medications are usually used||
1700|040|H|along with ivabradine to treat heart failure. Carefully follow||
1700|041|H|your doctor's directions for taking all your medications.||
1700|042|H|   If you are using the liquid form of this medication, read and||
1700|043|H|follow the Instructions for Use from the manufacturer. Carefully||
1700|044|H|measure the dose using a special measuring device/spoon. Do not||
1700|045|H|use a household spoon because you may not get the correct dose.||
1700|046|H|   Use this medication regularly to get the most benefit from it.||
1700|047|H|To help you remember, take it at the same times each day.||
1700|048|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1700|049|H|using this medication unless your doctor or pharmacist says you||
1700|050|H|may do so safely. Grapefruit can increase the chance of side||
1700|051|H|effects with this medicine. Ask your doctor or pharmacist for||
1700|052|H|more details.||
1700|053|H|   Tell your doctor if your condition does not get better or if||
1700|054|H|it gets worse.||
1700|055|B|||
1700|056|S|SIDE EFFECTS:  Dizziness or tiredness may occur. If either of||
1700|057|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1700|058|S|promptly.||
1700|059|S|   Remember that this medication has been prescribed because your||
1700|060|S|doctor has judged that the benefit to you is greater than the||
1700|061|S|risk of side effects. Many people using this medication do not||
1700|062|S|have serious side effects.||
1700|063|S|   Ivabradine may rarely cause vision changes such as brief||
1700|064|S|increased brightness, or seeing halos or colored bright lights.||
1700|065|S|Sudden changes in light brightness may set off this effect. If||
1700|066|S|vision changes happen, they usually start within the first 2||
1700|067|S|months and may go away during treatment or after stopping this||
1700|068|S|medication.||
1700|069|S|   Tell your doctor right away if you have any serious side||
1700|070|S|effects, including: slow/fast/irregular heartbeat, fainting.||
1700|071|S|   A very serious allergic reaction to this drug is rare.||
1700|072|S|However, get medical help right away if you notice any symptoms||
1700|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1700|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1700|075|S|breathing.||
1700|076|S|   This is not a complete list of possible side effects. If you||
1700|077|S|notice other effects not listed above, contact your doctor or||
1700|078|S|pharmacist.||
1700|079|S|   In the US -||
1700|080|S|   Call your doctor for medical advice about side effects. You||
1700|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1700|082|S|www.fda.gov/medwatch.||
1700|083|S|   In Canada - Call your doctor for medical advice about side||
1700|084|S|effects. You may report side effects to Health Canada at||
1700|085|S|1-866-234-2345.||
1700|086|B|||
1700|087|P|PRECAUTIONS:  Before taking ivabradine, tell your doctor or||
1700|088|P|pharmacist if you are allergic to it; or if you have any other||
1700|089|P|allergies. This product may contain inactive ingredients, which||
1700|090|P|can cause allergic reactions or other problems. Talk to your||
1700|091|P|pharmacist for more details.||
1700|092|P|   Before using this medication, tell your doctor or pharmacist||
1700|093|P|your medical history, especially of: low blood pressure, liver||
1700|094|P|problems, other heart problems (such as sick sinus syndrome,||
1700|095|P|heart block, slow/irregular heartbeat, pacemaker use).||
1700|096|P|   This drug may make you dizzy or cause vision changes. Alcohol||
1700|097|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
1700|098|P|use machinery, or do anything that needs alertness or clear||
1700|099|P|vision until you can do it safely. Be especially careful when||
1700|100|P|driving at night because sudden changes in light brightness can||
1700|101|P|happen, which may set off vision changes (see also Side Effects||
1700|102|P|section). Limit alcoholic beverages. Talk to your doctor if you||
1700|103|P|are using marijuana (cannabis).||
1700|104|P|   Before having surgery, tell your doctor or dentist about all||
1700|105|P|the products you use (including prescription drugs,||
1700|106|P|nonprescription drugs, and herbal products).||
1700|107|P|   Tell your doctor if you are pregnant or plan to become||
1700|108|P|pregnant. You should not become pregnant while using ivabradine.||
1700|109|P|Ivabradine may harm an unborn baby. Ask about reliable forms of||
1700|110|P|birth control while using this medication. If you become||
1700|111|P|pregnant, talk to your doctor right away about the risks and||
1700|112|P|benefits of this medication.||
1700|113|P|   It is unknown if this medication passes into breast milk.||
1700|114|P|Because of the possible risk to the infant, breastfeeding is not||
1700|115|P|recommended while using this medication. Consult your doctor||
1700|116|P|before breastfeeding.||
1700|117|B|||
1700|118|I|DRUG INTERACTIONS:  See also How to Use section.||
1700|119|I|   Drug interactions may change how your medications work or||
1700|120|I|increase your risk for serious side effects. This document does||
1700|121|I|not contain all possible drug interactions. Keep a list of all||
1700|122|I|the products you use (including prescription/nonprescription||
1700|123|I|drugs and herbal products) and share it with your doctor and||
1700|124|I|pharmacist. Do not start, stop, or change the dosage of any||
1700|125|I|medicines without your doctor's approval.||
1700|126|I|   Other medications can affect the removal of ivabradine from||
1700|127|I|your body, which may affect how ivabradine works. Examples||
1700|128|I|include azole antifungals (such as itraconazole, ketoconazole),||
1700|129|I|macrolide antibiotics (such as clarithromycin, telithromycin),||
1700|130|I|diltiazem, HIV protease inhibitors (such as nelfinavir),||
1700|131|I|nefazodone, rifamycins (such as rifabutin, rifampin), ritonavir,||
1700|132|I|St. John's wort, verapamil, drugs used to treat seizures (such as||
1700|133|I|carbamazepine, phenobarbital, phenytoin), among others.||
1700|134|B|||
1700|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1700|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1700|137|O|poison control center right away. US residents can call||
1700|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1700|139|O|Symptoms of overdose may include: very slow heartbeat.||
1700|140|B|||
1700|141|N|NOTES:  Do not share this medication with others.||
1700|142|N|   Lab and/or medical tests (such as pulse, blood pressure)||
1700|143|N|should be done while you are taking this medication. Keep all||
1700|144|N|medical and lab appointments. Consult your doctor for more||
1700|145|N|details.||
1700|146|B|||
1700|147|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1700|148|D|next dose at the regular time. Do not double the dose to catch||
1700|149|D|up.||
1700|150|B|||
1700|151|R|STORAGE:  Store at room temperature away from light and moisture.||
1700|152|R|Do not store in the bathroom. Keep all medications away from||
1700|153|R|children and pets.||
1700|154|R|   Do not flush medications down the toilet or pour them into a||
1700|155|R|drain unless instructed to do so. Properly discard this product||
1700|156|R|when it is expired or no longer needed. Consult your pharmacist||
1700|157|R|or local waste disposal company.||
1700|158|B|||
1700|159|A|Information last revised October 2024.||
1700|160|A|Copyright(c) 2025 First Databank, Inc.||
1700|161|B|||
1703|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1703|002|Z|does NOT have all possible information about this product. This||
1703|003|Z|information does not assure that this product is safe, effective,||
1703|004|Z|or appropriate for you. This information is not individual||
1703|005|Z|medical advice and does not substitute for the advice of your||
1703|006|Z|health care professional. Always ask your health care||
1703|007|Z|professional for complete information about this product and your||
1703|008|Z|specific health needs.||
1703|009|B|||
1703|010|T|LANTHANUM CARBONATE POWDER - ORAL||
1703|011|F|(LAN-tha-num KAR-bo-nate)||
1703|012|B|||
1703|013|C|COMMON BRAND NAME(S): Fosrenol||
1703|014|B|||
1703|015|U|USES:  Lanthanum is used to lower high blood phosphate levels in||
1703|016|U|people who are on dialysis due to severe kidney disease. Dialysis||
1703|017|U|removes some phosphate from your blood, but it is difficult to||
1703|018|U|remove enough to keep your phosphate levels balanced. Decreasing||
1703|019|U|blood phosphate levels can help keep your bones strong, prevent||
1703|020|U|unsafe buildup of minerals in your body, and may decrease the||
1703|021|U|risk of heart disease and strokes that can result from high||
1703|022|U|phosphate levels.||
1703|023|U|   Lanthanum is a natural mineral that works by binding to||
1703|024|U|phosphate in the foods you eat. The phosphate then passes out of||
1703|025|U|your body in your stool.||
1703|026|B|||
1703|027|H|HOW TO USE:  Read the Medication Guide provided by your||
1703|028|H|pharmacist before you start taking lanthanum and each time you||
1703|029|H|get a refill. If you have any questions, ask your doctor or||
1703|030|H|pharmacist.||
1703|031|H|   Take this medication by mouth as directed by your doctor,||
1703|032|H|usually with or right after meals. Sprinkle the powder on a small||
1703|033|H|amount of applesauce or soft food and swallow the mixture right||
1703|034|H|away. Do not open the powder packet until you are ready to use||
1703|035|H|it. Do not store the drug/food mixture for future use. Lanthanum||
1703|036|H|powder will not dissolve in liquid.||
1703|037|H|   Take this medication regularly to get the most benefit from||
1703|038|H|it. The dosage is based on your medical condition, response to||
1703|039|H|treatment, and lab tests.||
1703|040|H|   Lanthanum may stop some medications from working well if you||
1703|041|H|take them at the same time. Ask your pharmacist if you need to||
1703|042|H|separate the time that you take your other medications from the||
1703|043|H|time that you take lanthanum. See also Drug Interactions section.||
1703|044|B|||
1703|045|S|SIDE EFFECTS:  Nausea, vomiting, stomach pain, diarrhea, or||
1703|046|S|constipation may occur. If any of these effects last or get||
1703|047|S|worse, tell your doctor or pharmacist promptly.||
1703|048|S|   Remember that this medication has been prescribed because your||
1703|049|S|doctor has judged that the benefit to you is greater than the||
1703|050|S|risk of side effects. Many people using this medication do not||
1703|051|S|have serious side effects.||
1703|052|S|   Tell your doctor right away if you have any serious side||
1703|053|S|effects, including: mental/mood changes, unusual muscle||
1703|054|S|weakness/spasms, seizures.||
1703|055|S|   Rarely, a serious blockage of the bowels or a hole in the||
1703|056|S|bowels may occur, which may sometimes require surgery or going to||
1703|057|S|the hospital. Tell your doctor right away if you have:||
1703|058|S|stomach/abdominal pain that is severe or doesn't stop, vomiting||
1703|059|S|that doesn't stop, severe constipation, severe diarrhea, fever,||
1703|060|S|chills.||
1703|061|S|   A very serious allergic reaction to this drug is rare.||
1703|062|S|However, get medical help right away if you notice any symptoms||
1703|063|S|of a serious allergic reaction, including: rash, itching/swelling||
1703|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1703|065|S|breathing.||
1703|066|S|   This is not a complete list of possible side effects. If you||
1703|067|S|notice other effects not listed above, contact your doctor or||
1703|068|S|pharmacist.||
1703|069|S|   In the US -||
1703|070|S|   Call your doctor for medical advice about side effects. You||
1703|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1703|072|S|www.fda.gov/medwatch.||
1703|073|S|   In Canada - Call your doctor for medical advice about side||
1703|074|S|effects. You may report side effects to Health Canada at||
1703|075|S|1-866-234-2345.||
1703|076|B|||
1703|077|P|PRECAUTIONS:  Before taking lanthanum, tell your doctor or||
1703|078|P|pharmacist if you are allergic to it; or if you have any other||
1703|079|P|allergies. This product may contain inactive ingredients, which||
1703|080|P|can cause allergic reactions or other problems. Talk to your||
1703|081|P|pharmacist for more details.||
1703|082|P|   Before using this medication, tell your doctor or pharmacist||
1703|083|P|your medical history, especially of: stomach/intestinal problems||
1703|084|P|(such as ulcers, bowel blockage/surgery, cancer, constipation),||
1703|085|P|diabetes.||
1703|086|P|   Before having stomach/abdomen imaging (such as X-rays), tell||
1703|087|P|the medical personnel and all your doctors that you are taking||
1703|088|P|this medication.||
1703|089|P|   Before having surgery, tell your doctor or dentist about all||
1703|090|P|the products you use (including prescription drugs,||
1703|091|P|nonprescription drugs, and herbal products).||
1703|092|P|   This medication is not recommended for children because it may||
1703|093|P|affect the bones.||
1703|094|P|   During pregnancy, this medication should be used only when||
1703|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1703|096|P|   It is unknown if this drug passes into breast milk. Consult||
1703|097|P|your doctor before breastfeeding.||
1703|098|B|||
1703|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1703|100|I|medications work or increase your risk for serious side effects.||
1703|101|I|This document does not contain all possible drug interactions.||
1703|102|I|Keep a list of all the products you use (including||
1703|103|I|prescription/nonprescription drugs and herbal products) and share||
1703|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1703|105|I|the dosage of any medicines without your doctor's approval.||
1703|106|I|   Lanthanum may stop some medications from working well if you||
1703|107|I|take them at the same time. Ask your pharmacist for details||
1703|108|I|because you may need to separate the times you take lanthanum by||
1703|109|I|at least 2 hours from the times you take the following||
1703|110|I|medications, among others: mycophenolate, thyroid medications||
1703|111|I|(such as levothyroxine), tetracycline antibiotics (such as||
1703|112|I|doxycycline, tetracycline), drugs that interact with antacids.||
1703|113|I|   Other medications (such as quinolone antibiotics including||
1703|114|I|ciprofloxacin/levofloxacin) may require different separation time||
1703|115|I|schedules. Talk with your doctor or pharmacist about how to||
1703|116|I|schedule lanthanum and your other medications.||
1703|117|B|||
1703|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1703|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1703|120|O|poison control center right away. US residents can call||
1703|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1703|122|B|||
1703|123|N|NOTES:  Your doctor may tell you to follow a special diet to help||
1703|124|N|lower your blood phosphate levels. Follow the diet closely.||
1703|125|N|   Do not share this medication with others.||
1703|126|N|   Lab and/or medical tests (such as blood phosphate and calcium||
1703|127|N|levels) should be done while you are taking this medication. Keep||
1703|128|N|all medical and lab appointments. Consult your doctor for more||
1703|129|N|details.||
1703|130|B|||
1703|131|D|MISSED DOSE:  If you miss a dose, skip the missed dose unless you||
1703|132|D|have just eaten. If it is near the time of the next dose, skip||
1703|133|D|the missed dose. Take your next dose at the regular time. Do not||
1703|134|D|double the dose to catch up.||
1703|135|B|||
1703|136|R|STORAGE:  Store at room temperature away from light and moisture.||
1703|137|R|Do not store in the bathroom. Keep all medications away from||
1703|138|R|children and pets.||
1703|139|R|   Do not flush medications down the toilet or pour them into a||
1703|140|R|drain unless instructed to do so. Properly discard this product||
1703|141|R|when it is expired or no longer needed. Consult your pharmacist||
1703|142|R|or local waste disposal company.||
1703|143|B|||
1703|144|A|Information last revised May 2024.||
1703|145|A|Copyright(c) 2025 First Databank, Inc.||
1703|146|B|||
1704|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1704|002|Z|does NOT have all possible information about this product. This||
1704|003|Z|information does not assure that this product is safe, effective,||
1704|004|Z|or appropriate for you. This information is not individual||
1704|005|Z|medical advice and does not substitute for the advice of your||
1704|006|Z|health care professional. Always ask your health care||
1704|007|Z|professional for complete information about this product and your||
1704|008|Z|specific health needs.||
1704|009|B|||
1704|010|T|TIOTROPIUM/OLODATEROL - INHALATION||
1704|011|F|(TYE-oh-TROE-pee-um/OH-loe-DA-ter-ol)||
1704|012|B|||
1704|013|C|COMMON BRAND NAME(S): Stiolto Respimat||
1704|014|B|||
1704|015|U|USES:  This product is used to control and prevent symptoms (such||
1704|016|U|as wheezing and shortness of breath) caused by ongoing lung||
1704|017|U|disease (chronic obstructive pulmonary disease-COPD, which||
1704|018|U|includes chronic bronchitis and emphysema). Controlling symptoms||
1704|019|U|of breathing problems helps you stay active. This inhaler||
1704|020|U|contains 2 medications: tiotropium and olodaterol. Both drugs||
1704|021|U|work by relaxing the muscles around the airways so that they open||
1704|022|U|up and you can breathe more easily. Tiotropium belongs to a class||
1704|023|U|of drugs known as anticholinergics. Olodaterol belongs to the||
1704|024|U|class of drugs known as long-acting inhaled beta-agonists||
1704|025|U|(LABAs). Both drugs are also known as bronchodilators.||
1704|026|U|   This medication must be used regularly to be effective. It||
1704|027|U|does not work right away and should not be used to relieve sudden||
1704|028|U|shortness of breath. If sudden breathing problems occur, use your||
1704|029|U|quick-relief inhaler as prescribed.||
1704|030|U|   Tiotropium/olodaterol is not approved to treat asthma. People||
1704|031|U|with asthma using long-acting inhaled beta agonists (such as||
1704|032|U|olodaterol) without also using an inhaled corticosteroid may have||
1704|033|U|an increased risk of serious (sometimes fatal) breathing||
1704|034|U|problems.||
1704|035|B|||
1704|036|H|HOW TO USE:  Read the Patient Information Leaflet and||
1704|037|H|Instructions for Use provided by your pharmacist before you start||
1704|038|H|using this medication and each time you get a refill. Follow the||
1704|039|H|illustrated directions for the proper use of this medication. If||
1704|040|H|you have any questions, ask your doctor or pharmacist.||
1704|041|H|   Follow the instructions for priming the inhaler if you are||
1704|042|H|using it for the first time, or if you have not used it for more||
1704|043|H|than 3 days, or for more than 21 days. When priming the inhaler,||
1704|044|H|make sure to spray toward the ground (away from your face) so||
1704|045|H|that you do not get the medication in your eyes.||
1704|046|H|   Inhale this medication by mouth as directed by your doctor,||
1704|047|H|usually 2 puffs once daily. Wait at least 1 minute between each||
1704|048|H|inhalation.||
1704|049|H|   If you are using other inhalers at the same time, wait at||
1704|050|H|least one minute between the use of each medication.||
1704|051|H|   Use this medication regularly to get the most benefit from it.||
1704|052|H|Use it at the same time each day. Do not use it more than one||
1704|053|H|time each day.||
1704|054|H|   Do not increase your dose, use this medication more often, or||
1704|055|H|stop using it without first consulting your doctor. Your||
1704|056|H|condition will not improve any faster, and your risk of side||
1704|057|H|effects will increase.||
1704|058|H|   Learn which of your inhalers you should use every day and||
1704|059|H|which you should use if your breathing suddenly worsens||
1704|060|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1704|061|H|should do if you have new or worsening cough or shortness of||
1704|062|H|breath, wheezing, increased sputum, waking up at night with||
1704|063|H|trouble breathing, if you use your quick-relief inhaler more||
1704|064|H|often, or if your quick-relief inhaler does not seem to be||
1704|065|H|working well. Learn when you can treat sudden breathing problems||
1704|066|H|by yourself and when you must get medical help right away.||
1704|067|H|   If you have been using a quick-relief inhaler (albuterol,||
1704|068|H|salbutamol) on a regular daily schedule (such as 4 times daily),||
1704|069|H|your doctor will direct you to stop this schedule and only use||
1704|070|H|the quick-relief inhaler as needed for sudden shortness of||
1704|071|H|breath. Consult your doctor for details.||
1704|072|H|   Tell your doctor if your condition does not get better or if||
1704|073|H|it gets worse.||
1704|074|B|||
1704|075|S|SIDE EFFECTS:  Nervousness, shaking (tremor), or trouble sleeping||
1704|076|S|may occur. If any of these effects last or get worse, tell your||
1704|077|S|doctor or pharmacist promptly.||
1704|078|S|   Remember that this medication has been prescribed because your||
1704|079|S|doctor has judged that the benefit to you is greater than the||
1704|080|S|risk of side effects. Many people using this medication do not||
1704|081|S|have serious side effects.||
1704|082|S|   This medication may raise your blood pressure. Check your||
1704|083|S|blood pressure regularly and tell your doctor if the results are||
1704|084|S|high.||
1704|085|S|   Tell your doctor right away if you have any serious side||
1704|086|S|effects, including: muscle cramps/weakness, increased||
1704|087|S|thirst/urination, difficult/painful urination.||
1704|088|S|   Get medical help right away if you have any very serious side||
1704|089|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1704|090|S|dizziness, fainting, eye pain/swelling/redness, vision changes||
1704|091|S|(such as seeing rainbows around lights at night, blurred vision).||
1704|092|S|   Rarely, this medication may cause sudden, severe||
1704|093|S|wheezing/trouble breathing right after you use it. If this||
1704|094|S|happens, use your quick-relief inhaler and get medical help right||
1704|095|S|away.||
1704|096|S|   A very serious allergic reaction to this drug is rare.||
1704|097|S|However, get medical help right away if you notice any symptoms||
1704|098|S|of a serious allergic reaction, including: rash, itching/swelling||
1704|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1704|100|S|breathing.||
1704|101|S|   This is not a complete list of possible side effects. If you||
1704|102|S|notice other effects not listed above, contact your doctor or||
1704|103|S|pharmacist.||
1704|104|S|   In the US -||
1704|105|S|   Call your doctor for medical advice about side effects. You||
1704|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1704|107|S|www.fda.gov/medwatch.||
1704|108|S|   In Canada - Call your doctor for medical advice about side||
1704|109|S|effects. You may report side effects to Health Canada at||
1704|110|S|1-866-234-2345.||
1704|111|B|||
1704|112|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1704|113|P|pharmacist if you are allergic to tiotropium or olodaterol; or to||
1704|114|P|ipratropium; or if you have any other allergies. This product may||
1704|115|P|contain inactive ingredients, which can cause allergic reactions||
1704|116|P|or other problems. Talk to your pharmacist for more details.||
1704|117|P|   Before using this medication, tell your doctor or pharmacist||
1704|118|P|your medical history, especially of: heart problems (such as||
1704|119|P|chest pain, irregular heartbeat, previous heart attack), high||
1704|120|P|blood pressure, diabetes, kidney disease, personal or family||
1704|121|P|history of glaucoma (angle-closure type), seizures, overactive||
1704|122|P|thyroid, difficulty urinating (such as due to an enlarged||
1704|123|P|prostate).||
1704|124|P|   Olodaterol may cause a condition that affects the heart rhythm||
1704|125|P|(QT prolongation). QT prolongation can rarely cause serious||
1704|126|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1704|127|P|as severe dizziness, fainting) that need medical attention right||
1704|128|P|away.||
1704|129|P|   The risk of QT prolongation may be increased if you have||
1704|130|P|certain medical conditions or are taking other drugs that may||
1704|131|P|cause QT prolongation. Before using olodaterol, tell your doctor||
1704|132|P|or pharmacist of all the drugs you take and if you have any of||
1704|133|P|the following conditions: certain heart problems (heart failure,||
1704|134|P|slow heartbeat, QT prolongation in the EKG), family history of||
1704|135|P|certain heart problems (QT prolongation in the EKG, sudden||
1704|136|P|cardiac death).||
1704|137|P|   Low levels of potassium or magnesium in the blood may also||
1704|138|P|increase your risk of QT prolongation. This risk may increase if||
1704|139|P|you use certain drugs (such as diuretics/"water pills") or if you||
1704|140|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1704|141|P|Talk to your doctor about using this medication safely.||
1704|142|P|   Before having surgery, tell your doctor or dentist about all||
1704|143|P|the products you use (including prescription drugs,||
1704|144|P|nonprescription drugs, and herbal products).||
1704|145|P|   Older adults may be more sensitive to the side effects of this||
1704|146|P|drug, especially QT prolongation (see above).||
1704|147|P|   During pregnancy, this medication should be used only when||
1704|148|P|clearly needed. Discuss the risks and benefits with your doctor.||
1704|149|P|   It is unknown if this medication passes into breast milk.||
1704|150|P|Consult your doctor before breastfeeding.||
1704|151|B|||
1704|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1704|153|I|medications work or increase your risk for serious side effects.||
1704|154|I|This document does not contain all possible drug interactions.||
1704|155|I|Keep a list of all the products you use (including||
1704|156|I|prescription/nonprescription drugs and herbal products) and share||
1704|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
1704|158|I|the dosage of any medicines without your doctor's approval.||
1704|159|I|   Do not use other LABA drugs (such as arformoterol, salmeterol)||
1704|160|I|while using this medication.||
1704|161|B|||
1704|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1704|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1704|164|O|poison control center right away. US residents can call||
1704|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1704|166|O|Symptoms of overdose may include: chest pain, fast/irregular||
1704|167|O|heartbeat, severe dizziness, fainting.||
1704|168|B|||
1704|169|N|NOTES:  Do not share this medication with others.||
1704|170|N|   Lab and/or medical tests (such as blood pressure, pulse, lung||
1704|171|N|function) should be done while you are using this medication.||
1704|172|N|Keep all medical and lab appointments. Consult your doctor for||
1704|173|N|more details.||
1704|174|N|   Avoid substances that can worsen breathing problems by causing||
1704|175|N|irritation or allergic reaction, such as smoke, pollen, pet||
1704|176|N|dander, dust, and mold.||
1704|177|N|   Because the flu virus can worsen breathing problems, ask your||
1704|178|N|doctor or pharmacist if you should get a flu shot every year.||
1704|179|B|||
1704|180|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1704|181|D|If it is near the time of the next dose, skip the missed dose.||
1704|182|D|Use your next dose at the regular time. Do not double the dose to||
1704|183|D|catch up.||
1704|184|B|||
1704|185|R|STORAGE:  Store at room temperature. Do not freeze. Once the||
1704|186|R|cartridge is put into the inhaler, this medication expires after||
1704|187|R|3 months. Keep all medications away from children and pets.||
1704|188|R|   Do not flush medications down the toilet or pour them into a||
1704|189|R|drain unless instructed to do so. Properly discard this product||
1704|190|R|when it is expired or no longer needed. Consult your pharmacist||
1704|191|R|or local waste disposal company.||
1704|192|B|||
1704|193|M|MEDICAL ALERT:  Your condition can cause complications in a||
1704|194|M|medical emergency. For information about enrolling in MedicAlert,||
1704|195|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1704|196|B|||
1704|197|A|Information last revised July 2025.||
1704|198|A|Copyright(c) 2025 First Databank, Inc.||
1704|199|B|||
1705|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1705|002|Z|does NOT have all possible information about this product. This||
1705|003|Z|information does not assure that this product is safe, effective,||
1705|004|Z|or appropriate for you. This information is not individual||
1705|005|Z|medical advice and does not substitute for the advice of your||
1705|006|Z|health care professional. Always ask your health care||
1705|007|Z|professional for complete information about this product and your||
1705|008|Z|specific health needs.||
1705|009|B|||
1705|010|T|VARICELLA ZOSTER IMMUNE GLOBULIN - INJECTION||
1705|011|F|(VAR-i-SEL-a ZOS-ter i-MUNE GLOB-ue-lin)||
1705|012|B|||
1705|013|C|COMMON BRAND NAME(S): Varizig||
1705|014|B|||
1705|015|W|WARNING:  This medication may rarely cause serious problems from||
1705|016|W|blood clots (such as heart attack, stroke, blood clots in the||
1705|017|W|lungs or legs). You may be at increased risk for blood clots if||
1705|018|W|you are an older adult, are severely dehydrated, have a catheter||
1705|019|W|in a vein close to your heart for giving medications, or have a||
1705|020|W|history of blood clots, heart/blood vessel disease, heart||
1705|021|W|failure, stroke, or if you are immobile (such as on very long||
1705|022|W|plane flights or being bedridden). If you use estrogen-containing||
1705|023|W|products, these may also increase your risk. Before receiving||
1705|024|W|this medication, if you have any of these conditions report them||
1705|025|W|to your doctor or pharmacist.||
1705|026|W|   To decrease the risk of serious blood clots, drink enough||
1705|027|W|fluids to make sure you are not dehydrated before receiving this||
1705|028|W|medication. Get medical help right away if any of these symptoms||
1705|029|W|occur: shortness of breath/rapid breathing, chest/jaw/left arm||
1705|030|W|pain, unusual sweating, confusion, sudden dizziness/fainting,||
1705|031|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1705|032|W|trouble speaking, weakness on one side of the body, or sudden||
1705|033|W|vision changes.||
1705|034|B|||
1705|035|U|USES:  This medication is used to help provide protection||
1705|036|U|(antibodies) against a certain virus infection (varicella zoster)||
1705|037|U|commonly known as chickenpox. It is used by certain people who||
1705|038|U|have not been vaccinated or had the infection before and have had||
1705|039|U|recent contact with someone infected with chickenpox. This||
1705|040|U|medication is made from healthy human blood that has high levels||
1705|041|U|of a certain substance (varicella zoster antibodies) which helps||
1705|042|U|fight the infection.||
1705|043|U|   Routine vaccination is usually the best way to protect against||
1705|044|U|infection.||
1705|045|B|||
1705|046|H|HOW TO USE:  This medication is usually given by injection into a||
1705|047|H|muscle by a health care professional. Adults and children usually||
1705|048|H|receive the injection in the upper arm, and infants receive it in||
1705|049|H|the upper thigh. Large doses (more than 3 milliliters) should be||
1705|050|H|divided into 2 or more injections and given at separate injection||
1705|051|H|sites. Certain brands of this medication may be injected into a||
1705|052|H|vein. The dosage and schedule of injections depend on your||
1705|053|H|medical condition, weight, and response to treatment.||
1705|054|H|   This medication is given as soon as possible after you have||
1705|055|H|had contact with (been exposed to) someone with chickenpox. If||
1705|056|H|you wait too long after being exposed, the medication may not be||
1705|057|H|effective. Not everyone who is exposed to this infection should||
1705|058|H|receive varicella zoster immune globulin. Discuss the risks and||
1705|059|H|benefits with your doctor.||
1705|060|B|||
1705|061|S|SIDE EFFECTS:  See also Warning section.||
1705|062|S|   Pain at the injection site or headache may occur. If either of||
1705|063|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1705|064|S|promptly.||
1705|065|S|   Remember that this medication has been prescribed because your||
1705|066|S|doctor has judged that the benefit to you is greater than the||
1705|067|S|risk of side effects. Many people using this medication do not||
1705|068|S|have serious side effects.||
1705|069|S|   A very serious allergic reaction to this drug is rare.||
1705|070|S|However, get medical help right away if you notice any symptoms||
1705|071|S|of a serious allergic reaction, including: rash, itching/swelling||
1705|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1705|073|S|breathing.||
1705|074|S|   This is not a complete list of possible side effects. If you||
1705|075|S|notice other effects not listed above, contact your doctor or||
1705|076|S|pharmacist.||
1705|077|S|   In the US -||
1705|078|S|   Call your doctor for medical advice about side effects. You||
1705|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1705|080|S|www.fda.gov/medwatch.||
1705|081|S|   In Canada - Call your doctor for medical advice about side||
1705|082|S|effects. You may report side effects to Health Canada at||
1705|083|S|1-866-234-2345.||
1705|084|B|||
1705|085|P|PRECAUTIONS:  See also Warning section.||
1705|086|P|   Before using this medication, tell your doctor or pharmacist||
1705|087|P|if you are allergic to it; or to other immunoglobulin products||
1705|088|P|(such as IVIG); or if you have any other allergies. This product||
1705|089|P|may contain inactive ingredients, which can cause allergic||
1705|090|P|reactions or other problems. Talk to your pharmacist for more||
1705|091|P|details.||
1705|092|P|   Before using this medication, tell your doctor or pharmacist||
1705|093|P|your medical history, especially of: bleeding/blood clotting||
1705|094|P|problems, a certain immune system problem (immunoglobulin A||
1705|095|P|deficiency).||
1705|096|P|   This medication is made from human blood. Even though the||
1705|097|P|blood is carefully tested, and this medication goes through a||
1705|098|P|special manufacturing process, there is an extremely small chance||
1705|099|P|that you may get infections from the medication (for example,||
1705|100|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
1705|101|P|more information.||
1705|102|P|   Some immune globulin products are made with maltose. This||
1705|103|P|substance can cause false high blood sugar levels when your blood||
1705|104|P|sugar is normal or even low. If you have diabetes, check with||
1705|105|P|your pharmacist whether the product you are using contains||
1705|106|P|maltose and whether your blood sugar testing supplies will work||
1705|107|P|with this product. Rarely, serious problems have occurred when||
1705|108|P|too much insulin was given because of false high sugar readings||
1705|109|P|or when low blood sugar went untreated.||
1705|110|P|   Tell your doctor of any recent or planned||
1705|111|P|immunizations/vaccinations. This medication may prevent a good||
1705|112|P|response to certain live viral vaccines (such as measles, mumps,||
1705|113|P|rubella, varicella). If you have recently received any of these||
1705|114|P|vaccines, your doctor may have you tested for a response or have||
1705|115|P|you vaccinated again later. If you plan on getting any of these||
1705|116|P|vaccines, your doctor will tell you the best time to receive them||
1705|117|P|so you get a good response.||
1705|118|P|   Before having surgery, tell your doctor or dentist about all||
1705|119|P|the products you use (including prescription drugs,||
1705|120|P|nonprescription drugs, and herbal products).||
1705|121|P|   During pregnancy, this medication should be used only when||
1705|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
1705|123|P|   It is unknown if this drug passes into breast milk. Consult||
1705|124|P|your doctor before breastfeeding.||
1705|125|B|||
1705|126|I|DRUG INTERACTIONS:  See also Warning section.||
1705|127|I|   Drug interactions may change how your medications work or||
1705|128|I|increase your risk for serious side effects. This document does||
1705|129|I|not contain all possible drug interactions. Keep a list of all||
1705|130|I|the products you use (including prescription/nonprescription||
1705|131|I|drugs and herbal products) and share it with your doctor and||
1705|132|I|pharmacist. Do not start, stop, or change the dosage of any||
1705|133|I|medicines without your doctor's approval.||
1705|134|I|   This medication may interfere with certain lab tests (such as||
1705|135|I|certain blood sugar tests, Coomb's test), possibly causing false||
1705|136|I|test results. Make sure lab personnel and all your doctors know||
1705|137|I|you use this drug.||
1705|138|B|||
1705|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1705|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1705|141|O|poison control center right away. US residents can call||
1705|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1705|143|B|||
1705|144|N|NOTES:  Keep all medical and lab appointments.||
1705|145|B|||
1705|146|D|MISSED DOSE:  Not applicable.||
1705|147|B|||
1705|148|R|STORAGE:  Not applicable. This product is given in a hospital or||
1705|149|R|clinic or doctor's office and will not be stored at home.||
1705|150|R|   Do not flush medications down the toilet or pour them into a||
1705|151|R|drain unless instructed to do so. Properly discard this product||
1705|152|R|when it is expired or no longer needed. Consult your pharmacist||
1705|153|R|or local waste disposal company.||
1705|154|B|||
1705|155|A|Information last revised June 2025.||
1705|156|A|Copyright(c) 2025 First Databank, Inc.||
1705|157|B|||
1706|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1706|002|Z|does NOT have all possible information about this product. This||
1706|003|Z|information does not assure that this product is safe, effective,||
1706|004|Z|or appropriate for you. This information is not individual||
1706|005|Z|medical advice and does not substitute for the advice of your||
1706|006|Z|health care professional. Always ask your health care||
1706|007|Z|professional for complete information about this product and your||
1706|008|Z|specific health needs.||
1706|009|B|||
1706|010|T|PALIPERIDONE 3 MONTH - INTRAMUSCULAR INJECTION||
1706|011|F|(PAL-ee-PER-i-done)||
1706|012|B|||
1706|013|C|COMMON BRAND NAME(S): Invega Trinza||
1706|014|B|||
1706|015|W|WARNING:  There may be a slightly increased risk of serious,||
1706|016|W|possibly fatal side effects (such as stroke, heart failure,||
1706|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1706|018|W|by older adults with dementia. This medication is not approved||
1706|019|W|for the treatment of dementia-related behavior problems. Discuss||
1706|020|W|the risks and benefits of this medication, as well as other||
1706|021|W|effective and possibly safer treatments for dementia-related||
1706|022|W|behavior problems, with the doctor.||
1706|023|B|||
1706|024|U|USES:  This medication is used to treat a certain mental/mood||
1706|025|U|disorder (schizophrenia). Paliperidone belongs to a class of||
1706|026|U|drugs known as atypical antipsychotics. It works by helping to||
1706|027|U|restore the balance of certain natural substances in the brain.||
1706|028|U|   This long-acting form of paliperidone is used only after you||
1706|029|U|have received treatment with the form that is injected once a||
1706|030|U|month for at least 4 months.||
1706|031|B|||
1706|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1706|033|H|from your pharmacist before you start using paliperidone and each||
1706|034|H|time you get a refill. If you have any questions, ask your doctor||
1706|035|H|or pharmacist.||
1706|036|H|   This medication is given by injection into a muscle (upper arm||
1706|037|H|or buttocks) by a health care professional. The injections are||
1706|038|H|given as directed by your doctor, usually once every 3 months.||
1706|039|H|The dosage is based on your medical condition and response to||
1706|040|H|treatment.||
1706|041|H|   Use this medication regularly to get the most benefit from it.||
1706|042|H|To help you remember, mark your calendar with a reminder. Keep||
1706|043|H|using this medication even if you feel well. Do not stop using||
1706|044|H|this medication without consulting your doctor.||
1706|045|H|   Tell your doctor if your condition does not get better or if||
1706|046|H|it gets worse.||
1706|047|B|||
1706|048|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, drooling,||
1706|049|S|restlessness, weight gain, or pain/redness/swelling at the||
1706|050|S|injection site may occur. If any of these effects last or get||
1706|051|S|worse, tell your doctor or pharmacist promptly.||
1706|052|S|   Dizziness and lightheadedness can increase the risk of||
1706|053|S|falling. Get up slowly when rising from a sitting or lying||
1706|054|S|position.||
1706|055|S|   Remember that this medication has been prescribed because your||
1706|056|S|doctor has judged that the benefit to you is greater than the||
1706|057|S|risk of side effects. Many people using this medication do not||
1706|058|S|have serious side effects.||
1706|059|S|   Tell your doctor right away if you have any serious side||
1706|060|S|effects, including: difficulty swallowing, shaking (tremor),||
1706|061|S|muscle spasms, interrupted breathing during sleep.||
1706|062|S|   Get medical help right away if you have any very serious side||
1706|063|S|effects, including: fainting, severe dizziness, slow heartbeat,||
1706|064|S|seizures.||
1706|065|S|   Paliperidone may rarely cause a condition known as tardive||
1706|066|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1706|067|S|your doctor right away if you develop any unusual/uncontrolled||
1706|068|S|movements (especially of the face, lips, mouth, tongue, arms, or||
1706|069|S|legs).||
1706|070|S|   This medication may rarely cause a very serious condition||
1706|071|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1706|072|S|right away if you have any of the following symptoms: fever,||
1706|073|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1706|074|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1706|075|S|signs of kidney problems (such as change in the amount of urine).||
1706|076|S|   This medication may rarely make your blood sugar rise, which||
1706|077|S|can cause or worsen diabetes. Tell your doctor right away if you||
1706|078|S|have symptoms of high blood sugar such as increased||
1706|079|S|thirst/urination. If you already have diabetes, check your blood||
1706|080|S|sugar regularly as directed and share the results with your||
1706|081|S|doctor. Your doctor may need to adjust your diabetes medication,||
1706|082|S|exercise program, or diet.||
1706|083|S|   This drug may also cause significant weight gain and a rise in||
1706|084|S|your blood cholesterol (or triglyceride) levels. These effects,||
1706|085|S|along with diabetes, may increase your risk for developing heart||
1706|086|S|disease. Discuss the risks and benefits of treatment with your||
1706|087|S|doctor.||
1706|088|S|   Rarely, this medication may increase your blood level of a||
1706|089|S|certain hormone (prolactin). In females, an increase in prolactin||
1706|090|S|levels may result in unwanted breast milk, missed/stopped||
1706|091|S|periods, or difficulty becoming pregnant. In males, it may result||
1706|092|S|in decreased sexual ability, inability to produce sperm, or||
1706|093|S|enlarged breasts. If you develop any of these symptoms, tell your||
1706|094|S|doctor right away.||
1706|095|S|   Rarely, males may have a painful or prolonged erection lasting||
1706|096|S|4 or more hours. If this occurs, stop using this drug and get||
1706|097|S|medical help right away, or permanent problems could occur.||
1706|098|S|   A very serious allergic reaction to this drug is rare.||
1706|099|S|However, get medical help right away if you notice any symptoms||
1706|100|S|of a serious allergic reaction, including: fever, swollen lymph||
1706|101|S|nodes, rash, itching/swelling (especially of the||
1706|102|S|face/tongue/throat), severe dizziness, trouble breathing.||
1706|103|S|   This is not a complete list of possible side effects. If you||
1706|104|S|notice other effects not listed above, contact your doctor or||
1706|105|S|pharmacist.||
1706|106|S|   In the US -||
1706|107|S|   Call your doctor for medical advice about side effects. You||
1706|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1706|109|S|www.fda.gov/medwatch.||
1706|110|S|   In Canada - Call your doctor for medical advice about side||
1706|111|S|effects. You may report side effects to Health Canada at||
1706|112|S|1-866-234-2345.||
1706|113|B|||
1706|114|P|PRECAUTIONS:  See also Warning section.||
1706|115|P|   Before using paliperidone, tell your doctor or pharmacist if||
1706|116|P|you are allergic to it; or to risperidone; or if you have any||
1706|117|P|other allergies. This product may contain inactive ingredients,||
1706|118|P|which can cause allergic reactions or other problems. Talk to||
1706|119|P|your pharmacist for more details.||
1706|120|P|   Before using this medication, tell your doctor or pharmacist||
1706|121|P|your medical history, especially of: kidney disease, low white||
1706|122|P|blood cell count, Parkinson's disease, dementia, certain eye||
1706|123|P|problems (cataracts, glaucoma), seizures, personal or family||
1706|124|P|history of diabetes, high cholesterol/triglyceride levels, heart||
1706|125|P|disease (such as previous heart attack), breathing trouble during||
1706|126|P|sleep (sleep apnea).||
1706|127|P|   Paliperidone may cause a condition that affects the heart||
1706|128|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1706|129|P|serious (rarely fatal) fast/irregular heartbeat and other||
1706|130|P|symptoms (such as severe dizziness, fainting) that need medical||
1706|131|P|attention right away.||
1706|132|P|   The risk of QT prolongation may be increased if you have||
1706|133|P|certain medical conditions or are taking other drugs that may||
1706|134|P|cause QT prolongation. Before using paliperidone, tell your||
1706|135|P|doctor or pharmacist of all the drugs you take and if you have||
1706|136|P|any of the following conditions: certain heart problems (heart||
1706|137|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1706|138|P|history of certain heart problems (QT prolongation in the EKG,||
1706|139|P|sudden cardiac death).||
1706|140|P|   Low levels of potassium or magnesium in the blood may also||
1706|141|P|increase your risk of QT prolongation. This risk may increase if||
1706|142|P|you use certain drugs (such as diuretics/"water pills") or if you||
1706|143|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1706|144|P|Talk to your doctor about using paliperidone safely.||
1706|145|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1706|146|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1706|147|P|machinery, or do anything that needs alertness until you can do||
1706|148|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1706|149|P|are using marijuana (cannabis).||
1706|150|P|   This medication may make you sweat less, making you more||
1706|151|P|likely to get heat stroke. Avoid doing things that may cause you||
1706|152|P|to overheat, such as hard work or exercise in hot weather, or||
1706|153|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1706|154|P|and dress lightly. If you overheat, quickly look for a place to||
1706|155|P|cool down and rest. Get medical help right away if you have a||
1706|156|P|fever that does not go away, mental/mood changes, headache, or||
1706|157|P|dizziness.||
1706|158|P|   Before having surgery (including cataract/glaucoma eye||
1706|159|P|surgery), tell your doctor or dentist if you are using or have||
1706|160|P|ever used this medication, and about all the other products you||
1706|161|P|use (including prescription drugs, nonprescription drugs, and||
1706|162|P|herbal products).||
1706|163|P|   Older adults may be more sensitive to the side effects of this||
1706|164|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
1706|165|P|prolongation (see above). Drowsiness, dizziness, and||
1706|166|P|lightheadedness can increase the risk of falling.||
1706|167|P|   During pregnancy, this medication should be used only when||
1706|168|P|clearly needed. Babies born to mothers who have used this drug||
1706|169|P|during the last 3 months of pregnancy may rarely develop symptoms||
1706|170|P|including muscle stiffness or shakiness, drowsiness,||
1706|171|P|feeding/breathing difficulties, or constant crying. If you notice||
1706|172|P|any of these symptoms in your newborn especially during their||
1706|173|P|first month, tell the doctor right away.||
1706|174|P|   Since untreated mental/mood problems (such as schizophrenia)||
1706|175|P|can be a serious condition, do not stop taking this medication||
1706|176|P|unless directed by your doctor. If you are planning pregnancy,||
1706|177|P|become pregnant, or think you may be pregnant, talk with your||
1706|178|P|doctor right away about the benefits and risks of using this||
1706|179|P|medication during pregnancy.||
1706|180|P|   This medication passes into breast milk and may have||
1706|181|P|undesirable effects on a nursing infant. Tell the doctor right||
1706|182|P|away if your baby develops symptoms such as muscle stiffness or||
1706|183|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
1706|184|P|your doctor before breastfeeding.||
1706|185|B|||
1706|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1706|187|I|medications work or increase your risk for serious side effects.||
1706|188|I|This document does not contain all possible drug interactions.||
1706|189|I|Keep a list of all the products you use (including||
1706|190|I|prescription/nonprescription drugs and herbal products) and share||
1706|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
1706|192|I|the dosage of any medicines without your doctor's approval.||
1706|193|I|   A product that may interact with this drug is: metoclopramide.||
1706|194|I|   Many drugs besides paliperidone may affect the heart rhythm||
1706|195|I|(QT prolongation), including amiodarone, chlorpromazine,||
1706|196|I|disopyramide, dofetilide, dronedarone, moxifloxacin, quinidine,||
1706|197|I|sotalol, procainamide, thioridazine, among others.||
1706|198|I|   Tell your doctor or pharmacist if you are taking other||
1706|199|I|products that cause drowsiness such as opioid pain or cough||
1706|200|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1706|201|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1706|202|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1706|203|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1706|204|I|diphenhydramine).||
1706|205|I|   Check the labels on all your medicines (such as allergy or||
1706|206|I|cough-and-cold products) because they may contain ingredients||
1706|207|I|that cause drowsiness. Ask your pharmacist about using those||
1706|208|I|products safely.||
1706|209|B|||
1706|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1706|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1706|212|O|poison control center right away. US residents can call||
1706|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1706|214|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
1706|215|O|fast/irregular heartbeat, muscle stiffness/spasms, restlessness,||
1706|216|O|unusual/uncontrolled movements.||
1706|217|B|||
1706|218|N|NOTES:  Lab and/or medical tests (such as blood sugar, kidney||
1706|219|N|function, cholesterol/triglyceride levels, blood pressure,||
1706|220|N|weight) may be done while you are using this medication. Keep all||
1706|221|N|medical and lab appointments. Consult your doctor for more||
1706|222|N|details.||
1706|223|B|||
1706|224|D|MISSED DOSE:  It is important to get each dose of this medication||
1706|225|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1706|226|D|right away for a new dosing schedule.||
1706|227|B|||
1706|228|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1706|229|R|doctor's office and will not be stored at home.||
1706|230|B|||
1706|231|A|Information last revised October 2024.||
1706|232|A|Copyright(c) 2025 First Databank, Inc.||
1706|233|B|||
1707|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1707|002|Z|does NOT have all possible information about this product. This||
1707|003|Z|information does not assure that this product is safe, effective,||
1707|004|Z|or appropriate for you. This information is not individual||
1707|005|Z|medical advice and does not substitute for the advice of your||
1707|006|Z|health care professional. Always ask your health care||
1707|007|Z|professional for complete information about this product and your||
1707|008|Z|specific health needs.||
1707|009|B|||
1707|010|T|PROBIOTICS/DIGESTIVE ENZYMES - ORAL||
1707|011|B|||
1707|012|U|USES:  This product contains probiotics and digestive enzymes.||
1707|013|U|Probiotics have different types of bacteria. Some conditions||
1707|014|U|(such as antibiotic use, travel) can change the normal balance of||
1707|015|U|bacteria (flora) found in the stomach and intestines. Probiotics||
1707|016|U|are used to improve digestion and restore normal flora. Digestive||
1707|017|U|enzymes (such as lipase, lactase) are natural substances needed||
1707|018|U|by the body to help break down and digest food.||
1707|019|U|   Probiotics with digestive enzymes have been used to prevent||
1707|020|U|bowel symptoms (such as gas, bloating, abdominal discomfort) and||
1707|021|U|to treat lactose intolerance. Different products have different||
1707|022|U|uses. Check the label for information on uses for your particular||
1707|023|U|product.||
1707|024|U|   This product should not be used as replacement treatment for||
1707|025|U|digestive enzymes (such as in cystic fibrosis, cancer of the||
1707|026|U|pancreas).||
1707|027|U|   Some supplement products have been found to contain possibly||
1707|028|U|harmful impurities/additives. Check with your pharmacist for||
1707|029|U|details about the brand you use.||
1707|030|U|   The FDA has not reviewed this product for safety or||
1707|031|U|effectiveness. Consult your doctor or pharmacist for more||
1707|032|U|details.||
1707|033|B|||
1707|034|H|HOW TO USE:  Follow all directions on the product package. If||
1707|035|H|your doctor has prescribed this product, take it as directed. If||
1707|036|H|you have any questions, ask your doctor or pharmacist.||
1707|037|H|   Antibiotics may prevent this product from working well. Take||
1707|038|H|this product at least 2 hours before or after taking antibiotics.||
1707|039|H|   If your condition lasts or gets worse, or if you think you may||
1707|040|H|have a serious medical problem, get medical help right away.||
1707|041|B|||
1707|042|S|SIDE EFFECTS:  Diarrhea, constipation, abdominal pain/cramps,||
1707|043|S|nausea, vomiting, gas, or bloating may occur. If any of these||
1707|044|S|effects last or get worse, tell your doctor or pharmacist||
1707|045|S|promptly.||
1707|046|S|   Tell your doctor right away if you have any serious side||
1707|047|S|effects, including: signs of infection (such as sore throat that||
1707|048|S|doesn't go away, fever, chills).||
1707|049|S|   A very serious allergic reaction to this product is rare.||
1707|050|S|However, get medical help right away if you notice any symptoms||
1707|051|S|of a serious allergic reaction, including: rash, itching/swelling||
1707|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1707|053|S|breathing.||
1707|054|S|   This is not a complete list of possible side effects. If you||
1707|055|S|notice other effects not listed above, contact your doctor or||
1707|056|S|pharmacist.||
1707|057|S|   In the US -||
1707|058|S|   Call your doctor for medical advice about side effects. You||
1707|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1707|060|S|www.fda.gov/medwatch.||
1707|061|S|   In Canada - Call your doctor for medical advice about side||
1707|062|S|effects. You may report side effects to Health Canada at||
1707|063|S|1-866-234-2345.||
1707|064|B|||
1707|065|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1707|066|P|pharmacist if you are allergic to it; or if you have any other||
1707|067|P|allergies. This product may contain inactive ingredients, which||
1707|068|P|can cause allergic reactions or other problems. Talk to your||
1707|069|P|pharmacist for more details.||
1707|070|P|   If you have any of the following health problems, consult your||
1707|071|P|doctor or pharmacist before using this product: disease of the||
1707|072|P|pancreas, diarrhea lasting more than 2 days (especially if you||
1707|073|P|also have a high fever), weakened immune system (such as due to||
1707|074|P|chemotherapy, HIV infection), a certain intestinal disorder||
1707|075|P|(short bowel syndrome).||
1707|076|P|   Before having surgery, tell your doctor or dentist about all||
1707|077|P|the products you use (including prescription drugs,||
1707|078|P|nonprescription drugs, and herbal products).||
1707|079|P|   During pregnancy, this product should be used only when||
1707|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
1707|081|P|   It is unknown if this product passes into breast milk. Consult||
1707|082|P|your doctor before breastfeeding.||
1707|083|B|||
1707|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1707|085|I|medications work or increase your risk for serious side effects.||
1707|086|I|This document does not contain all possible drug interactions.||
1707|087|I|Keep a list of all the products you use (including||
1707|088|I|prescription/nonprescription drugs and herbal products) and share||
1707|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
1707|090|I|the dosage of any medicines without your doctor's approval.||
1707|091|I|   Some drugs that may interact with this product are: acarbose,||
1707|092|I|antibiotics, miglitol.||
1707|093|B|||
1707|094|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1707|095|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1707|096|O|poison control center right away. US residents can call||
1707|097|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1707|098|B|||
1707|099|N|NOTES:  Keep all medical and lab appointments.||
1707|100|B|||
1707|101|D|MISSED DOSE:  If you are taking this product on a regular||
1707|102|D|schedule and miss a dose, take it as soon as you remember. If it||
1707|103|D|is near the time of the next dose, skip the missed dose. Take||
1707|104|D|your next dose at the regular time. Do not double the dose to||
1707|105|D|catch up.||
1707|106|B|||
1707|107|R|STORAGE:  Refer to storage information printed on the package. If||
1707|108|R|you have any questions about storage, ask your pharmacist. Keep||
1707|109|R|all medications away from children and pets.||
1707|110|R|   Do not flush medications down the toilet or pour them into a||
1707|111|R|drain unless instructed to do so. Properly discard this product||
1707|112|R|when it is expired or no longer needed. Consult your pharmacist||
1707|113|R|or local waste disposal company.||
1707|114|B|||
1707|115|A|Information last revised May 2024.||
1707|116|A|Copyright(c) 2025 First Databank, Inc.||
1707|117|B|||
1709|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1709|002|Z|does NOT have all possible information about this product. This||
1709|003|Z|information does not assure that this product is safe, effective,||
1709|004|Z|or appropriate for you. This information is not individual||
1709|005|Z|medical advice and does not substitute for the advice of your||
1709|006|Z|health care professional. Always ask your health care||
1709|007|Z|professional for complete information about this product and your||
1709|008|Z|specific health needs.||
1709|009|B|||
1709|010|T|DINUTUXIMAB - INJECTION||
1709|011|F|(DIN-ue-TUX-i-mab)||
1709|012|B|||
1709|013|C|COMMON BRAND NAME(S): Unituxin||
1709|014|B|||
1709|015|W|WARNING:  Serious infusion reactions (sometimes fatal) or nerve||
1709|016|W|problems (such as nerve pain) may happen during the infusion of||
1709|017|W|this drug and for some time afterward. Your doctor may prescribe||
1709|018|W|other medications (such as acetaminophen, diphenhydramine,||
1709|019|W|opioids) before each treatment to help prevent these side||
1709|020|W|effects. Get medical help right away if you have any symptoms of||
1709|021|W|infusion reactions such as fever, chills, severe dizziness,||
1709|022|W|swelling of the face/tongue/throat, trouble breathing, itching,||
1709|023|W|or rash. Also tell your doctor right away if you have any||
1709|024|W|symptoms of nerve pain such as numbness, burning, tingling, or||
1709|025|W|weakness, or if you have pain that is not relieved. Your doctor||
1709|026|W|may give you other medications to help with these side effects or||
1709|027|W|may slow down or stop your treatment for some time.||
1709|028|B|||
1709|029|U|USES:  This medication is used to treat a certain type of cancer||
1709|030|U|(high-risk neuroblastoma). Dinutuximab belongs to a class of||
1709|031|U|drugs known as monoclonal antibodies. It works by slowing or||
1709|032|U|stopping the growth of cancer cells.||
1709|033|B|||
1709|034|H|HOW TO USE:  See also Warning section.||
1709|035|H|   This medication is given by slow injection (infusion) into a||
1709|036|H|vein as directed by your doctor, usually over 10 to 20 hours, for||
1709|037|H|4 days in a row during each treatment cycle.||
1709|038|H|   The dosage and treatment schedule are based on your medical||
1709|039|H|condition, body size, and response to treatment.||
1709|040|H|   Use this medication regularly to get the most benefit from it.||
1709|041|H|To help you remember, mark your calendar with a reminder.||
1709|042|B|||
1709|043|S|SIDE EFFECTS:  See also Warning section.||
1709|044|S|   Nausea, vomiting, diarrhea, dizziness, or lightheadedness may||
1709|045|S|occur. If any of these effects last or get worse, tell your||
1709|046|S|doctor or pharmacist promptly.||
1709|047|S|   To reduce the risk of dizziness and lightheadedness, get up||
1709|048|S|slowly when rising from a sitting or lying position.||
1709|049|S|   People using this medication may have serious side effects.||
1709|050|S|However, you have been prescribed this drug because your doctor||
1709|051|S|has judged that the benefit to you is greater than the risk of||
1709|052|S|side effects. Careful monitoring by your doctor may decrease your||
1709|053|S|risk.||
1709|054|S|   Tell your doctor right away if you have any serious side||
1709|055|S|effects, including: mental/mood changes (such as confusion),||
1709|056|S|muscle/joint pain, stomach/abdominal pain, difficulty urinating,||
1709|057|S|signs of kidney problems (such as blood in the urine, change in||
1709|058|S|the amount of urine).||
1709|059|S|   Get medical help right away if you have any very serious side||
1709|060|S|effects, including: seizures, severe headache.||
1709|061|S|   This medication may lower your ability to fight infections.||
1709|062|S|This may make you more likely to get a serious (rarely fatal)||
1709|063|S|infection or make any infection you have worse. Tell your doctor||
1709|064|S|right away if you have any signs of infection (such as sore||
1709|065|S|throat that doesn't go away, fever, chills).||
1709|066|S|   This medication can rarely cause a serious condition||
1709|067|S|(capillary leak syndrome), that can sometimes be fatal. Tell your||
1709|068|S|doctor right away if you develop symptoms including swelling,||
1709|069|S|severe dizziness, or tiredness.||
1709|070|S|   Rarely, this medication may cause a nerve problem of the||
1709|071|S|eye(s). Tell your doctor right away if you develop symptoms such||
1709|072|S|as blurred vision, double vision, drooping upper eyelid, or||
1709|073|S|sensitivity to light.||
1709|074|S|   A very serious allergic reaction to this drug is rare.||
1709|075|S|However, get medical help right away if you notice any symptoms||
1709|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1709|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1709|078|S|breathing.||
1709|079|S|   This is not a complete list of possible side effects. If you||
1709|080|S|notice other effects not listed above, contact your doctor or||
1709|081|S|pharmacist.||
1709|082|S|   In the US -||
1709|083|S|   Call your doctor for medical advice about side effects. You||
1709|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1709|085|S|www.fda.gov/medwatch.||
1709|086|S|   In Canada - Call your doctor for medical advice about side||
1709|087|S|effects. You may report side effects to Health Canada at||
1709|088|S|1-866-234-2345.||
1709|089|B|||
1709|090|P|PRECAUTIONS:  Before using dinutuximab, tell your doctor or||
1709|091|P|pharmacist if you are allergic to it; or if you have any other||
1709|092|P|allergies. This product may contain inactive ingredients, which||
1709|093|P|can cause allergic reactions or other problems. Talk to your||
1709|094|P|pharmacist for more details.||
1709|095|P|   Before using this medication, tell your doctor or pharmacist||
1709|096|P|your medical history, especially of: blood/bleeding problems,||
1709|097|P|kidney problems.||
1709|098|P|   Dinutuximab can make you more likely to get infections or may||
1709|099|P|make current infections worse. Stay away from anyone who has an||
1709|100|P|infection that may easily spread (such as chickenpox, COVID-19,||
1709|101|P|measles, flu). Talk to your doctor if you have been exposed to an||
1709|102|P|infection or for more details.||
1709|103|P|   Tell your health care professional that you are using||
1709|104|P|dinutuximab before having any immunizations/vaccinations. Avoid||
1709|105|P|contact with people who have recently received live vaccines||
1709|106|P|(such as flu vaccine inhaled through the nose).||
1709|107|P|   To lower the chance of getting cut, bruised, or injured, use||
1709|108|P|caution with sharp objects like razors and nail cutters, and||
1709|109|P|avoid activities such as contact sports.||
1709|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1709|111|P|can make you more dizzy. Do not drive, use machinery, or do||
1709|112|P|anything that needs alertness until you can do it safely. Limit||
1709|113|P|alcoholic beverages. Talk to your doctor if you are using||
1709|114|P|marijuana (cannabis).||
1709|115|P|   Before having surgery, tell your doctor or dentist about all||
1709|116|P|the products you use (including prescription drugs,||
1709|117|P|nonprescription drugs, and herbal products).||
1709|118|P|   Tell your doctor if you are pregnant or plan to become||
1709|119|P|pregnant. You should not become pregnant while using dinutuximab.||
1709|120|P|Dinutuximab may harm an unborn baby. Ask about reliable forms of||
1709|121|P|birth control while using this medication and for at least 2||
1709|122|P|months after the last dose. If you become pregnant, talk to your||
1709|123|P|doctor right away about the risks and benefits of this||
1709|124|P|medication.||
1709|125|P|   It is unknown if this drug passes into breast milk. Because of||
1709|126|P|the possible risk to the infant, breastfeeding is not recommended||
1709|127|P|while using this drug. Consult your doctor before breastfeeding.||
1709|128|B|||
1709|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1709|130|I|medications work or increase your risk for serious side effects.||
1709|131|I|This document does not contain all possible drug interactions.||
1709|132|I|Keep a list of all the products you use (including||
1709|133|I|prescription/nonprescription drugs and herbal products) and share||
1709|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
1709|135|I|the dosage of any medicines without your doctor's approval.||
1709|136|B|||
1709|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1709|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1709|139|O|poison control center right away. US residents can call||
1709|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1709|141|B|||
1709|142|N|NOTES:  Lab and/or medical tests (such as blood pressure,||
1709|143|N|complete blood count, blood minerals) should be done while you||
1709|144|N|are using this medication. Keep all medical and lab appointments.||
1709|145|N|Consult your doctor for more details.||
1709|146|B|||
1709|147|D|MISSED DOSE:  It is important to get each dose of this medication||
1709|148|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1709|149|D|right away for a new dosing schedule.||
1709|150|B|||
1709|151|R|STORAGE:  Not applicable. This medication is given in a hospital||
1709|152|R|or clinic and will not be stored at home.||
1709|153|B|||
1709|154|M|MEDICAL ALERT:  Your condition can cause complications in a||
1709|155|M|medical emergency. For information about enrolling in MedicAlert,||
1709|156|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1709|157|B|||
1709|158|A|Information last revised April 2025.||
1709|159|A|Copyright(c) 2025 First Databank, Inc.||
1709|160|B|||
1710|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1710|002|Z|does NOT have all possible information about this product. This||
1710|003|Z|information does not assure that this product is safe, effective,||
1710|004|Z|or appropriate for you. This information is not individual||
1710|005|Z|medical advice and does not substitute for the advice of your||
1710|006|Z|health care professional. Always ask your health care||
1710|007|Z|professional for complete information about this product and your||
1710|008|Z|specific health needs.||
1710|009|B|||
1710|010|T|SACUBITRIL/VALSARTAN - ORAL||
1710|011|F|(sak-UE-bi-tril/val-SAR-tan)||
1710|012|B|||
1710|013|C|COMMON BRAND NAME(S): Entresto||
1710|014|B|||
1710|015|W|WARNING:  Valsartan can cause serious (possibly fatal) harm to an||
1710|016|W|unborn baby if used during pregnancy. It is important to prevent||
1710|017|W|pregnancy while taking this medication. Consult your doctor for||
1710|018|W|more details and to discuss the use of reliable forms of birth||
1710|019|W|control while taking this medication. If you are planning||
1710|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
1710|021|W|your doctor right away.||
1710|022|B|||
1710|023|U|USES:  This product is used to treat certain types of heart||
1710|024|U|failure. It may help you live longer and lower your chance of||
1710|025|U|having to go to the hospital for heart failure. This product||
1710|026|U|contains 2 medications: sacubitril and valsartan. Sacubitril||
1710|027|U|belongs to a class of drugs called neprilysin inhibitors and||
1710|028|U|valsartan belongs to a class of drugs called angiotensin receptor||
1710|029|U|blockers (ARBs). They work by relaxing blood vessels so that||
1710|030|U|blood can flow more easily, which makes it easier for your heart||
1710|031|U|to pump blood to your body.||
1710|032|B|||
1710|033|H|HOW TO USE:  Read the Patient Information Leaflet and||
1710|034|H|Instructions for Use if available from your pharmacist before you||
1710|035|H|start taking this product and each time you get a refill. If you||
1710|036|H|have any questions, ask your doctor or pharmacist.||
1710|037|H|   Take this product by mouth with or without food as directed by||
1710|038|H|your doctor, usually twice daily. The dosage is based on your||
1710|039|H|medical condition and response to treatment. Children's dosage is||
1710|040|H|also based on weight.||
1710|041|H|   If you are using the suspension form of this medication, shake||
1710|042|H|the bottle well before each dose. Carefully measure the dose||
1710|043|H|using a special measuring device/spoon. Do not use a household||
1710|044|H|spoon because you may not get the correct dose.||
1710|045|H|   If you are using the capsule that contains pellets, do not||
1710|046|H|swallow these capsules whole. You must open the capsule(s) and||
1710|047|H|sprinkle the pellets on 1 to 2 teaspoonfuls (5-10 milliliters) of||
1710|048|H|soft food as directed. Take the mixture right away. Do not store||
1710|049|H|the mixture for later use. Do not crush or chew the pellets||
1710|050|H|before swallowing. Throw away the empty capsule shell(s) in the||
1710|051|H|trash. Do not give the pellets through a feeding tube.||
1710|052|H|   To reduce your risk of side effects, your doctor may direct||
1710|053|H|you to start this product at a low dose and gradually increase||
1710|054|H|your dose. Follow your doctor's instructions carefully.||
1710|055|H|   This product should not be taken with ACE inhibitors (such as||
1710|056|H|captopril, enalapril) since your risk of serious side effects may||
1710|057|H|increase. Do not take this product for at least 36 hours before||
1710|058|H|or after taking an ACE inhibitor. Consult your doctor or||
1710|059|H|pharmacist for more details.||
1710|060|H|   Use this medication regularly to get the most benefit from it.||
1710|061|H|To help you remember, take it at the same times each day.||
1710|062|H|   Tell your doctor if you do not get better or if you get worse.||
1710|063|B|||
1710|064|S|SIDE EFFECTS:  Cough, dizziness, or lightheadedness may occur. If||
1710|065|S|any of these effects last or get worse, tell your doctor or||
1710|066|S|pharmacist promptly.||
1710|067|S|   To reduce the risk of dizziness and lightheadedness, get up||
1710|068|S|slowly when rising from a sitting or lying position.||
1710|069|S|   Remember that this medication has been prescribed because your||
1710|070|S|doctor has judged that the benefit to you is greater than the||
1710|071|S|risk of side effects. Many people using this medication do not||
1710|072|S|have serious side effects.||
1710|073|S|   Tell your doctor right away if you have any serious side||
1710|074|S|effects, including: signs of kidney problems (such as change in||
1710|075|S|the amount of urine), symptoms of a high potassium blood level||
1710|076|S|(such as muscle weakness, slow/irregular heartbeat), fainting.||
1710|077|S|   A very serious allergic reaction to this drug is rare.||
1710|078|S|However, get medical help right away if you notice any symptoms||
1710|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1710|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1710|081|S|breathing.||
1710|082|S|   This is not a complete list of possible side effects. If you||
1710|083|S|notice other effects not listed above, contact your doctor or||
1710|084|S|pharmacist.||
1710|085|S|   In the US -||
1710|086|S|   Call your doctor for medical advice about side effects. You||
1710|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1710|088|S|www.fda.gov/medwatch.||
1710|089|S|   In Canada - Call your doctor for medical advice about side||
1710|090|S|effects. You may report side effects to Health Canada at||
1710|091|S|1-866-234-2345.||
1710|092|B|||
1710|093|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1710|094|P|pharmacist if you are allergic to sacubitril; or to valsartan; or||
1710|095|P|to other ARBs (such as candesartan, losartan); or to ACE||
1710|096|P|inhibitors (such as quinapril, ramipril); or if you have any||
1710|097|P|other allergies. This product may contain inactive ingredients,||
1710|098|P|which can cause allergic reactions or other problems. Talk to||
1710|099|P|your pharmacist for more details.||
1710|100|P|   Before using this medication, tell your doctor or pharmacist||
1710|101|P|your medical history, especially of: liver disease, kidney||
1710|102|P|disease, dehydration, high level of potassium in the blood,||
1710|103|P|serious allergic reaction conditions that included swelling of||
1710|104|P|your face/lips/tongue/throat/trouble breathing (such as||
1710|105|P|angioedema, hereditary angioedema).||
1710|106|P|   This product may make you dizzy. Alcohol or marijuana||
1710|107|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
1710|108|P|or do anything that needs alertness until you can do it safely.||
1710|109|P|Limit alcoholic beverages. Talk to your doctor if you are using||
1710|110|P|marijuana (cannabis).||
1710|111|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1710|112|P|and cause you to feel lightheaded. Tell your doctor if you have||
1710|113|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1710|114|P|of fluids unless your doctor tells you not to.||
1710|115|P|   This product may increase your potassium levels. Before using||
1710|116|P|potassium supplements or salt substitutes that contain potassium,||
1710|117|P|consult your doctor or pharmacist.||
1710|118|P|   Before having surgery, tell your doctor or dentist about all||
1710|119|P|the products you use (including prescription drugs,||
1710|120|P|nonprescription drugs, and herbal products).||
1710|121|P|   Tell your doctor if you are pregnant or plan to become||
1710|122|P|pregnant. You should not become pregnant while using||
1710|123|P|sacubitril/valsartan. Valsartan may harm an unborn baby. If you||
1710|124|P|become pregnant, talk to your doctor right away about the risks||
1710|125|P|and benefits of this medication. (See also Warning section.)||
1710|126|P|   It is unknown if this product passes into breast milk. Consult||
1710|127|P|your doctor before breastfeeding.||
1710|128|B|||
1710|129|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
1710|130|I|   Drug interactions may change how your medications work or||
1710|131|I|increase your risk for serious side effects. This document does||
1710|132|I|not contain all possible drug interactions. Keep a list of all||
1710|133|I|the products you use (including prescription/nonprescription||
1710|134|I|drugs and herbal products) and share it with your doctor and||
1710|135|I|pharmacist. Do not start, stop, or change the dosage of any||
1710|136|I|medicines without your doctor's approval.||
1710|137|I|   Some products that may interact with this medication include:||
1710|138|I|aliskiren, lithium, drugs that may increase the level of||
1710|139|I|potassium in the blood (such as sparsentan, ACE inhibitors||
1710|140|I|including benazepril/lisinopril, birth control pills containing||
1710|141|I|drospirenone).||
1710|142|I|   Some products have ingredients that could worsen your heart||
1710|143|I|failure. Tell your pharmacist what products you are using, and||
1710|144|I|ask how to use them safely (especially cough-and-cold products,||
1710|145|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1710|146|B|||
1710|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1710|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1710|149|O|poison control center right away. US residents can call||
1710|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1710|151|O|Symptoms of overdose may include: severe dizziness, fainting.||
1710|152|B|||
1710|153|N|NOTES:  Do not share this product with others.||
1710|154|N|   Lab and/or medical tests (such as kidney function, potassium||
1710|155|N|levels) should be done while you are taking this product. Keep||
1710|156|N|all medical and lab appointments.||
1710|157|B|||
1710|158|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1710|159|D|remember. If it is near the time of the next dose, skip the||
1710|160|D|missed dose. Take your next dose at the regular time. Do not||
1710|161|D|double the dose to catch up.||
1710|162|B|||
1710|163|R|STORAGE:  Store at room temperature away from light and moisture.||
1710|164|R|Do not store in the bathroom. Discard any unused suspension after||
1710|165|R|15 days. Do not store the suspension in the refrigerator. Keep||
1710|166|R|all medications away from children and pets.||
1710|167|R|   Do not flush medications down the toilet or pour them into a||
1710|168|R|drain unless instructed to do so. Properly discard this product||
1710|169|R|when it is expired or no longer needed. Consult your pharmacist||
1710|170|R|or local waste disposal company.||
1710|171|B|||
1710|172|A|Information last revised January 2025.||
1710|173|A|Copyright(c) 2025 First Databank, Inc.||
1710|174|B|||
1711|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1711|002|Z|does NOT have all possible information about this product. This||
1711|003|Z|information does not assure that this product is safe, effective,||
1711|004|Z|or appropriate for you. This information is not individual||
1711|005|Z|medical advice and does not substitute for the advice of your||
1711|006|Z|health care professional. Always ask your health care||
1711|007|Z|professional for complete information about this product and your||
1711|008|Z|specific health needs.||
1711|009|B|||
1711|010|T|BREXPIPRAZOLE - ORAL||
1711|011|F|(brex-PIP-ra-zole)||
1711|012|B|||
1711|013|C|COMMON BRAND NAME(S): Rexulti||
1711|014|B|||
1711|015|W|WARNING:  There may be a slightly increased risk of serious,||
1711|016|W|possibly fatal side effects (such as stroke, heart failure,||
1711|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1711|018|W|by older adults with dementia. This medication is not approved||
1711|019|W|for the treatment of dementia-related behavior problems without||
1711|020|W|agitation that may occur with dementia due to Alzheimer's||
1711|021|W|disease. Discuss the risks and benefits of this medication, as||
1711|022|W|well as other effective and possibly safer treatments for||
1711|023|W|dementia-related behavior problems, with the doctor. See also||
1711|024|W|Uses section.||
1711|025|W|   Brexpiprazole is used to treat certain mental/mood disorders||
1711|026|W|(such as schizophrenia, depression). Drugs used to treat||
1711|027|W|depression can help prevent suicidal thoughts/attempts and||
1711|028|W|provide other important benefits. However, studies have shown||
1711|029|W|that a small number of people (especially people younger than 25)||
1711|030|W|who take antidepressants for any condition may experience||
1711|031|W|worsening depression, other mental/mood symptoms, or suicidal||
1711|032|W|thoughts/attempts. It is very important to talk with the doctor||
1711|033|W|about the risks and benefits of drugs used to treat depression||
1711|034|W|(especially for people younger than 25), even if treatment is not||
1711|035|W|for a mental/mood condition.||
1711|036|W|   Tell the doctor right away if you notice worsening||
1711|037|W|depression/other psychiatric conditions, unusual behavior changes||
1711|038|W|(including possible suicidal thoughts/attempts), or other||
1711|039|W|mental/mood changes (including new/worsening anxiety, panic||
1711|040|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
1711|041|W|impulsive actions, severe restlessness, very rapid speech). Be||
1711|042|W|especially watchful for these symptoms when a new drug to treat||
1711|043|W|depression is started or when the dose is changed.||
1711|044|B|||
1711|045|U|USES:  This medication is used to treat certain mental/mood||
1711|046|U|disorders (such as schizophrenia, depression). Brexpiprazole is||
1711|047|U|also used to treat agitation that may occur with dementia due to||
1711|048|U|Alzheimer's disease. Brexpiprazole belongs to a class of drugs||
1711|049|U|known as atypical antipsychotics. It works by helping to restore||
1711|050|U|the balance of certain natural substances in the brain.||
1711|051|B|||
1711|052|H|HOW TO USE:  Read the Medication Guide provided by your||
1711|053|H|pharmacist before you start taking brexpiprazole and each time||
1711|054|H|you get a refill. If you have any questions, ask your doctor or||
1711|055|H|pharmacist.||
1711|056|H|   Take this medication by mouth with or without food as directed||
1711|057|H|by your doctor, usually once daily. The dosage is based on your||
1711|058|H|medical condition, response to treatment, and other drugs you may||
1711|059|H|be taking. Be sure to tell your doctor and pharmacist about all||
1711|060|H|the products you use (including prescription drugs,||
1711|061|H|nonprescription drugs, and herbal products).||
1711|062|H|   To reduce your risk of side effects, your doctor may direct||
1711|063|H|you to start this medication at a low dose and gradually increase||
1711|064|H|your dose. Follow your doctor's instructions carefully.||
1711|065|H|   Take this medication regularly to get the most benefit from||
1711|066|H|it. To help you remember, take it at the same time each day.||
1711|067|H|   Keep taking this medication exactly as prescribed, even if you||
1711|068|H|are feeling better and thinking more clearly. Do not increase||
1711|069|H|your dose or take this drug more often than prescribed. Your||
1711|070|H|symptoms will not improve any faster, and your risk of side||
1711|071|H|effects will increase. Do not stop taking this medication without||
1711|072|H|consulting your doctor.||
1711|073|H|   Tell your doctor if you do not get better or if you get worse.||
1711|074|H|It may take several weeks before you feel the full benefit of||
1711|075|H|this medication.||
1711|076|B|||
1711|077|S|SIDE EFFECTS:  See also Warning section.||
1711|078|S|   Drowsiness, dizziness, lightheadedness, shaking, increased||
1711|079|S|appetite, weight gain, restlessness, and inability to keep still||
1711|080|S|may occur. If any of these effects last or get worse, tell your||
1711|081|S|doctor or pharmacist promptly.||
1711|082|S|   This medication may cause a serious drop in blood pressure,||
1711|083|S|especially after starting or increasing your dose of this||
1711|084|S|medication. Dizziness and lightheadedness can increase the risk||
1711|085|S|of falling. Get up slowly when rising from a sitting or lying||
1711|086|S|position.||
1711|087|S|   Remember that this medication has been prescribed because your||
1711|088|S|doctor has judged that the benefit to you is greater than the||
1711|089|S|risk of side effects. Many people using this medication do not||
1711|090|S|have serious side effects.||
1711|091|S|   Tell your doctor right away if you have any serious side||
1711|092|S|effects, including: trouble swallowing, fainting, interrupted||
1711|093|S|breathing during sleep, unusual strong urges (such as increased||
1711|094|S|gambling, increased sexual urges).||
1711|095|S|   Brexpiprazole may rarely cause a condition known as tardive||
1711|096|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1711|097|S|your doctor right away if you develop any unusual/uncontrolled||
1711|098|S|movements (especially of the face, lips, mouth, tongue, arms, or||
1711|099|S|legs).||
1711|100|S|   This medication may rarely make your blood sugar rise, which||
1711|101|S|can cause or worsen diabetes. Tell your doctor right away if you||
1711|102|S|have symptoms of high blood sugar such as increased||
1711|103|S|thirst/urination. If you already have diabetes, check your blood||
1711|104|S|sugar regularly as directed and share the results with your||
1711|105|S|doctor. Your doctor may need to adjust your diabetes medication,||
1711|106|S|exercise program, or diet.||
1711|107|S|   This drug may also cause weight gain and a rise in your blood||
1711|108|S|cholesterol (or triglyceride) levels. These effects, along with||
1711|109|S|diabetes, may increase your risk for developing heart disease.||
1711|110|S|Discuss the risks and benefits of treatment with your doctor.||
1711|111|S|   Rarely, this medication may increase your blood level of a||
1711|112|S|certain hormone (prolactin). In females, an increase in prolactin||
1711|113|S|levels may result in unwanted breast milk, missed/stopped||
1711|114|S|periods, or difficulty becoming pregnant. In males, it may result||
1711|115|S|in decreased sexual ability, inability to produce sperm, or||
1711|116|S|enlarged breasts. If you develop any of these symptoms, tell your||
1711|117|S|doctor right away.||
1711|118|S|   Get medical help right away if you have any very serious side||
1711|119|S|effects, including: seizure.||
1711|120|S|   This medication may rarely cause a very serious condition||
1711|121|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1711|122|S|right away if you have any of the following symptoms: fever,||
1711|123|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1711|124|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1711|125|S|signs of kidney problems (such as change in the amount of urine).||
1711|126|S|   A very serious allergic reaction to this drug is rare.||
1711|127|S|However, get medical help right away if you notice any symptoms||
1711|128|S|of a serious allergic reaction, including: rash, itching/swelling||
1711|129|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1711|130|S|breathing.||
1711|131|S|   This is not a complete list of possible side effects. If you||
1711|132|S|notice other effects not listed above, contact your doctor or||
1711|133|S|pharmacist.||
1711|134|S|   In the US -||
1711|135|S|   Call your doctor for medical advice about side effects. You||
1711|136|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1711|137|S|www.fda.gov/medwatch.||
1711|138|S|   In Canada - Call your doctor for medical advice about side||
1711|139|S|effects. You may report side effects to Health Canada at||
1711|140|S|1-866-234-2345.||
1711|141|B|||
1711|142|P|PRECAUTIONS:  See also Warning section.||
1711|143|P|   Before taking brexpiprazole, tell your doctor or pharmacist if||
1711|144|P|you are allergic to it; or if you have any other allergies. This||
1711|145|P|product may contain inactive ingredients, which can cause||
1711|146|P|allergic reactions or other problems. Talk to your pharmacist for||
1711|147|P|more details.||
1711|148|P|   Before using this medication, tell your doctor or pharmacist||
1711|149|P|your medical history, especially of: kidney problems, liver||
1711|150|P|problems, personal or family history of diabetes, high||
1711|151|P|cholesterol/triglyceride levels, heart problems, seizures,||
1711|152|P|stroke, trouble swallowing, low white blood cell count, breathing||
1711|153|P|trouble during sleep (sleep apnea).||
1711|154|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1711|155|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1711|156|P|machinery, or do anything that needs alertness until you can do||
1711|157|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1711|158|P|are using marijuana (cannabis).||
1711|159|P|   Before having surgery, tell your doctor or dentist about all||
1711|160|P|the products you use (including prescription drugs,||
1711|161|P|nonprescription drugs, and herbal products).||
1711|162|P|   This medication may make you sweat less, making you more||
1711|163|P|likely to get heat stroke. Avoid doing things that may cause you||
1711|164|P|to overheat, such as hard work or exercise in hot weather, or||
1711|165|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1711|166|P|and dress lightly. If you overheat, quickly look for a place to||
1711|167|P|cool down and rest. Get medical help right away if you have a||
1711|168|P|fever that does not go away, mental/mood changes, headache, or||
1711|169|P|dizziness.||
1711|170|P|   Older adults may be more sensitive to the side effects of this||
1711|171|P|drug, especially drowsiness, dizziness, and lightheadedness.||
1711|172|P|Drowsiness, dizziness, and lightheadedness can increase the risk||
1711|173|P|of falling.||
1711|174|P|   During pregnancy, this medication should be used only when||
1711|175|P|clearly needed. Babies born to mothers who have used this drug||
1711|176|P|during the last 3 months of pregnancy may rarely develop symptoms||
1711|177|P|including muscle stiffness or shakiness, drowsiness,||
1711|178|P|feeding/breathing difficulties, or constant crying. If you notice||
1711|179|P|any of these symptoms in your newborn, especially during their||
1711|180|P|first month, tell the doctor right away.||
1711|181|P|   Since untreated mental/mood problems (such as schizophrenia,||
1711|182|P|depression) can be a serious condition, do not stop taking this||
1711|183|P|medication unless directed by your doctor. If you are planning||
1711|184|P|pregnancy, become pregnant, or think you may be pregnant, talk||
1711|185|P|with your doctor right away about the benefits and risks of using||
1711|186|P|this medication during pregnancy.||
1711|187|P|   It is unknown if this medication passes into breast milk.||
1711|188|P|Consult your doctor before breastfeeding.||
1711|189|B|||
1711|190|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1711|191|I|medications work or increase your risk for serious side effects.||
1711|192|I|This document does not contain all possible drug interactions.||
1711|193|I|Keep a list of all the products you use (including||
1711|194|I|prescription/nonprescription drugs and herbal products) and share||
1711|195|I|it with your doctor and pharmacist. Do not start, stop, or change||
1711|196|I|the dosage of any medicines without your doctor's approval.||
1711|197|I|   A product that may interact with this drug is: metoclopramide.||
1711|198|I|   Tell your doctor or pharmacist if you are taking other||
1711|199|I|products that cause drowsiness such as opioid pain or cough||
1711|200|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1711|201|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1711|202|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1711|203|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1711|204|I|diphenhydramine).||
1711|205|I|   Check the labels on all your medicines (such as allergy or||
1711|206|I|cough-and-cold products) because they may contain ingredients||
1711|207|I|that cause drowsiness. Ask your pharmacist about using those||
1711|208|I|products safely.||
1711|209|B|||
1711|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1711|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1711|212|O|poison control center right away. US residents can call||
1711|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1711|214|B|||
1711|215|N|NOTES:  Do not share this medication with others.||
1711|216|N|   Lab and/or medical tests (such as blood sugar, blood pressure,||
1711|217|N|kidney/liver function, weight, cholesterol/triglyceride levels)||
1711|218|N|may be done while you are taking this medication. Keep all||
1711|219|N|medical and lab appointments.||
1711|220|B|||
1711|221|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1711|222|D|remember. If it is near the time of the next dose, skip the||
1711|223|D|missed dose. Take your next dose at the regular time. Do not||
1711|224|D|double the dose to catch up.||
1711|225|B|||
1711|226|R|STORAGE:  Store at room temperature away from light and moisture.||
1711|227|R|Do not store in the bathroom. Keep all medications away from||
1711|228|R|children and pets.||
1711|229|R|   Do not flush medications down the toilet or pour them into a||
1711|230|R|drain unless instructed to do so. Properly discard this product||
1711|231|R|when it is expired or no longer needed. Consult your pharmacist||
1711|232|R|or local waste disposal company.||
1711|233|B|||
1711|234|A|Information last revised May 2024.||
1711|235|A|Copyright(c) 2025 First Databank, Inc.||
1711|236|B|||
1712|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1712|002|Z|does NOT have all possible information about this product. This||
1712|003|Z|information does not assure that this product is safe, effective,||
1712|004|Z|or appropriate for you. This information is not individual||
1712|005|Z|medical advice and does not substitute for the advice of your||
1712|006|Z|health care professional. Always ask your health care||
1712|007|Z|professional for complete information about this product and your||
1712|008|Z|specific health needs.||
1712|009|B|||
1712|010|T|PERINDOPRIL/AMLODIPINE - ORAL||
1712|011|F|(per-IN-doe-pril/am-LOE-di-peen)||
1712|012|B|||
1712|013|C|COMMON BRAND NAME(S): Prestalia||
1712|014|B|||
1712|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
1712|016|W|unborn baby if used during pregnancy. It is important to prevent||
1712|017|W|pregnancy while taking this medication. Consult your doctor for||
1712|018|W|more details and to discuss the use of reliable forms of birth||
1712|019|W|control while taking this medication. If you are planning||
1712|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
1712|021|W|your doctor right away.||
1712|022|B|||
1712|023|U|USES:  This product is used to treat high blood pressure. It||
1712|024|U|contains 2 medications: perindopril and amlodipine. Lowering high||
1712|025|U|blood pressure helps prevent strokes, heart attacks, and kidney||
1712|026|U|problems. Perindopril belongs to a class of drugs known as ACE||
1712|027|U|inhibitors and amlodipine belongs to a class of drugs known as||
1712|028|U|calcium channel blockers. Both of them work by relaxing blood||
1712|029|U|vessels so blood can flow more easily.||
1712|030|B|||
1712|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1712|032|H|from your pharmacist before you start taking this product and||
1712|033|H|each time you get a refill. If you have any questions, ask your||
1712|034|H|doctor or pharmacist.||
1712|035|H|   Take this medication by mouth with or without food as directed||
1712|036|H|by your doctor, usually once daily.||
1712|037|H|   To reduce your risk of side effects, your doctor may direct||
1712|038|H|you to start this product at a low dose and gradually increase||
1712|039|H|your dose. Follow your doctor's instructions carefully.||
1712|040|H|   The dosage is based on your medical condition and response to||
1712|041|H|treatment.||
1712|042|H|   Take this medication regularly to get the most benefit from||
1712|043|H|it. To help you remember, take it at the same time each day. Keep||
1712|044|H|taking this medication even if you feel well. Most people with||
1712|045|H|high blood pressure do not feel sick.||
1712|046|H|   It may take 1 to 2 weeks before you get the full benefit of||
1712|047|H|this drug.||
1712|048|H|   Tell your doctor if your condition does not get better or if||
1712|049|H|it gets worse (your blood pressure readings remain high or||
1712|050|H|increase).||
1712|051|B|||
1712|052|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
1712|053|S|body adjusts to the medication. Dry cough, swelling||
1712|054|S|hands/ankles/feet, flushing, or nausea may also occur. If any of||
1712|055|S|these effects last or get worse, tell your doctor or pharmacist||
1712|056|S|promptly.||
1712|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
1712|058|S|slowly when rising from a sitting or lying position.||
1712|059|S|   Remember that this medication has been prescribed because your||
1712|060|S|doctor has judged that the benefit to you is greater than the||
1712|061|S|risk of side effects. Many people using this medication do not||
1712|062|S|have serious side effects.||
1712|063|S|   Tell your doctor right away if you have any serious side||
1712|064|S|effects, including: fainting, fast/irregular/pounding heartbeat,||
1712|065|S|symptoms of a high potassium blood level (such as muscle||
1712|066|S|weakness, slow/irregular heartbeat), signs of kidney problems||
1712|067|S|(such as a change in the amount of urine).||
1712|068|S|   Some people who already have severe heart disease may rarely||
1712|069|S|develop worsening chest pain or a heart attack after starting||
1712|070|S|this medication or increasing the dose. Get medical help right||
1712|071|S|away if you experience: worsening chest pain, symptoms of a heart||
1712|072|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
1712|073|S|unusual sweating).||
1712|074|S|   This product may rarely cause serious (possibly fatal) liver||
1712|075|S|problems. Get medical help right away if you have any symptoms of||
1712|076|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1712|077|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1712|078|S|urine.||
1712|079|S|   A very serious allergic reaction to this drug is rare.||
1712|080|S|However, get medical help right away if you notice any symptoms||
1712|081|S|of a serious allergic reaction, including: rash, itching/swelling||
1712|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1712|083|S|breathing.||
1712|084|S|   This is not a complete list of possible side effects. If you||
1712|085|S|notice other effects not listed above, contact your doctor or||
1712|086|S|pharmacist.||
1712|087|S|   In the US -||
1712|088|S|   Call your doctor for medical advice about side effects. You||
1712|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1712|090|S|www.fda.gov/medwatch.||
1712|091|S|   In Canada - Call your doctor for medical advice about side||
1712|092|S|effects. You may report side effects to Health Canada at||
1712|093|S|1-866-234-2345.||
1712|094|B|||
1712|095|P|PRECAUTIONS:  See also Side Effects section.||
1712|096|P|   Before taking this product, tell your doctor or pharmacist if||
1712|097|P|you are allergic to perindopril; or to amlodipine; or to other||
1712|098|P|ACE inhibitors (such as enalapril, lisinopril); or to other||
1712|099|P|calcium channel blockers (such as nisoldipine, nifedipine); or if||
1712|100|P|you have any other allergies. This product may contain inactive||
1712|101|P|ingredients, which can cause allergic reactions or other||
1712|102|P|problems. Talk to your pharmacist for more details.||
1712|103|P|   Before using this medication, tell your doctor or pharmacist||
1712|104|P|your medical history, especially of: history of an allergic||
1712|105|P|reaction which included swelling of the face/lips/tongue/throat||
1712|106|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
1712|107|P|dialysis), high level of potassium in the blood, a certain||
1712|108|P|structural heart problem (aortic stenosis), liver disease,||
1712|109|P|dehydration.||
1712|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1712|111|P|can make you more dizzy. Do not drive, use machinery, or do||
1712|112|P|anything that needs alertness until you can do it safely. Limit||
1712|113|P|alcoholic beverages. Talk to your doctor if you are using||
1712|114|P|marijuana (cannabis).||
1712|115|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1712|116|P|and cause you to feel lightheaded. Tell your doctor if you have||
1712|117|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1712|118|P|of fluids unless your doctor tells you not to.||
1712|119|P|   This product may increase your potassium levels. Before using||
1712|120|P|potassium supplements or salt substitutes that contain potassium,||
1712|121|P|consult your doctor or pharmacist.||
1712|122|P|   Before having surgery, tell your doctor or dentist about all||
1712|123|P|the products you use (including prescription drugs,||
1712|124|P|nonprescription drugs, and herbal products).||
1712|125|P|   Older adults may be more sensitive to the side effects of this||
1712|126|P|drug, especially dizziness, high potassium levels, and rash.||
1712|127|P|   Tell your doctor if you are pregnant or plan to become||
1712|128|P|pregnant. You should not become pregnant while using this||
1712|129|P|product. Perindopril may harm an unborn baby. If you become||
1712|130|P|pregnant, talk to your doctor right away about the risks and||
1712|131|P|benefits of this medication. (See also Warning section.)||
1712|132|P|   Amlodipine passes into breast milk. It is unknown if||
1712|133|P|perindopril passes into breast milk. Consult your doctor before||
1712|134|P|breastfeeding.||
1712|135|B|||
1712|136|I|DRUG INTERACTIONS:  See also Precautions section.||
1712|137|I|   Drug interactions may change how your medications work or||
1712|138|I|increase your risk for serious side effects. This document does||
1712|139|I|not contain all possible drug interactions. Keep a list of all||
1712|140|I|the products you use (including prescription/nonprescription||
1712|141|I|drugs and herbal products) and share it with your doctor and||
1712|142|I|pharmacist. Do not start, stop, or change the dosage of any||
1712|143|I|medicines without your doctor's approval.||
1712|144|I|   Some products that may interact with this drug include:||
1712|145|I|aliskiren, certain drugs that weaken the immune system/increase||
1712|146|I|the risk of infection (such as everolimus, sirolimus), gold||
1712|147|I|injections, lithium, drugs that may increase the level of||
1712|148|I|potassium in the blood (such as ARBs including||
1712|149|I|losartan/valsartan, birth control pills containing drospirenone),||
1712|150|I|sacubitril.||
1712|151|I|   Some products have ingredients that could raise your blood||
1712|152|I|pressure. Tell your pharmacist what products you are using, and||
1712|153|I|ask how to use them safely (especially cough-and-cold products,||
1712|154|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
1712|155|I|   A very serious reaction may occur if you are getting||
1712|156|I|injections for bee/wasp sting allergy (desensitization) and are||
1712|157|I|also taking this product. Make sure all your doctors know which||
1712|158|I|medicines you are using.||
1712|159|B|||
1712|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1712|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1712|162|O|poison control center right away. US residents can call||
1712|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1712|164|O|Symptoms of overdose may include: severe dizziness, fainting,||
1712|165|O|fast/slow heartbeat.||
1712|166|B|||
1712|167|N|NOTES:  Do not share this medication with others.||
1712|168|N|   Lifestyle changes that may help this medication work better||
1712|169|N|include exercising, stopping smoking, and eating a||
1712|170|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1712|171|N|details.||
1712|172|N|   Lab and/or medical tests (such as kidney function, potassium||
1712|173|N|levels) should be done while you are taking this medication. Keep||
1712|174|N|all medical and lab appointments. Consult your doctor for more||
1712|175|N|details.||
1712|176|N|   Check your blood pressure and pulse (heart rate) regularly||
1712|177|N|while taking this medication. Learn how to check your own blood||
1712|178|N|pressure and pulse at home, and share the results with your||
1712|179|N|doctor.||
1712|180|B|||
1712|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1712|182|D|remember. If it is more than 12 hours after the missed dose, skip||
1712|183|D|the missed dose. Take your next dose at the regular time. Do not||
1712|184|D|double the dose to catch up.||
1712|185|B|||
1712|186|R|STORAGE:  Store at room temperature away from light and moisture.||
1712|187|R|Do not store in the bathroom. Keep all medications away from||
1712|188|R|children and pets.||
1712|189|R|   Do not flush medications down the toilet or pour them into a||
1712|190|R|drain unless instructed to do so. Properly discard this product||
1712|191|R|when it is expired or no longer needed. Consult your pharmacist||
1712|192|R|or local waste disposal company.||
1712|193|B|||
1712|194|A|Information last revised May 2024.||
1712|195|A|Copyright(c) 2025 First Databank, Inc.||
1712|196|B|||
1714|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1714|002|Z|does NOT have all possible information about this product. This||
1714|003|Z|information does not assure that this product is safe, effective,||
1714|004|Z|or appropriate for you. This information is not individual||
1714|005|Z|medical advice and does not substitute for the advice of your||
1714|006|Z|health care professional. Always ask your health care||
1714|007|Z|professional for complete information about this product and your||
1714|008|Z|specific health needs.||
1714|009|B|||
1714|010|T|ALIROCUMAB - SUBCUTANEOUS INJECTION||
1714|011|F|(AL-i-ROK-ue-mab)||
1714|012|B|||
1714|013|C|COMMON BRAND NAME(S): Praluent||
1714|014|B|||
1714|015|U|USES:  Alirocumab is used by people who have blockage in the||
1714|016|U|heart blood vessels to reduce the risk of heart attack, stroke,||
1714|017|U|and certain types of chest pain that require treatment in a||
1714|018|U|hospital. It is also used by people who have an inherited||
1714|019|U|condition that causes high levels of LDL. Treatment with||
1714|020|U|alirocumab, a proper diet, and cholesterol-lowering drugs can||
1714|021|U|help lower "bad" cholesterol (LDL) in the blood. Alirocumab||
1714|022|U|belongs to a class of drugs known as monoclonal antibodies. It||
1714|023|U|works by improving how well your body gets rid of LDL||
1714|024|U|cholesterol.||
1714|025|U|   In addition to eating a proper diet (such as a||
1714|026|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
1714|027|U|help this medication work better include exercising, losing||
1714|028|U|weight if overweight, and stopping smoking. Consult your doctor||
1714|029|U|for more details.||
1714|030|B|||
1714|031|H|HOW TO USE:  Read the Patient Information Leaflet and||
1714|032|H|Instructions for Use if available from your pharmacist before you||
1714|033|H|start using alirocumab and each time you get a refill. Ask your||
1714|034|H|health care professional how to prepare and use this medication.||
1714|035|H|If you have any questions, ask your doctor or pharmacist.||
1714|036|H|   Inject this medication under the skin as directed by your||
1714|037|H|doctor, usually once every 2 weeks or once every 4 weeks||
1714|038|H|(monthly). The injection is given in the thigh, abdomen, or upper||
1714|039|H|arm. The dosage is based on your medical condition and response||
1714|040|H|to treatment. Children's dosage is also based on weight.||
1714|041|H|   Depending on your product, take the medication out of the||
1714|042|H|refrigerator at least 30 to 45 minutes before you inject it to||
1714|043|H|allow it to reach room temperature. Do not warm up this||
1714|044|H|medication any other way (for example, do not heat it in the||
1714|045|H|microwave, place it in hot water, or leave it in direct||
1714|046|H|sunlight). Do not shake the medication. Before using, check this||
1714|047|H|product for particles or discoloration. If either is present, do||
1714|048|H|not use the liquid. Before injecting each dose, clean the skin||
1714|049|H|you are going to inject into (the injection site) with rubbing||
1714|050|H|alcohol. Change the injection site each time to lessen injury||
1714|051|H|under the skin. Do not inject into skin that is injured, tender,||
1714|052|H|hard, red, or hot. To lessen bruising, do not rub the injection||
1714|053|H|site after a shot. Learn how to store and discard medical||
1714|054|H|supplies safely.||
1714|055|H|   Use this medication regularly to get the most benefit from it.||
1714|056|H|To help you remember, mark your calendar with a reminder.||
1714|057|B|||
1714|058|S|SIDE EFFECTS:  Redness, itching, swelling, or pain at the||
1714|059|S|injection site may occur. If any of these effects last or get||
1714|060|S|worse, tell your doctor or pharmacist promptly.||
1714|061|S|   Remember that this medication has been prescribed because your||
1714|062|S|doctor has judged that the benefit to you is greater than the||
1714|063|S|risk of side effects. Many people using this medication do not||
1714|064|S|have serious side effects.||
1714|065|S|   A very serious allergic reaction to this drug is rare.||
1714|066|S|However, get medical help right away if you notice any symptoms||
1714|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1714|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1714|069|S|breathing.||
1714|070|S|   This is not a complete list of possible side effects. If you||
1714|071|S|notice other effects not listed above, contact your doctor or||
1714|072|S|pharmacist.||
1714|073|S|   In the US -||
1714|074|S|   Call your doctor for medical advice about side effects. You||
1714|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1714|076|S|www.fda.gov/medwatch.||
1714|077|S|   In Canada - Call your doctor for medical advice about side||
1714|078|S|effects. You may report side effects to Health Canada at||
1714|079|S|1-866-234-2345.||
1714|080|B|||
1714|081|P|PRECAUTIONS:  Before using alirocumab, tell your doctor or||
1714|082|P|pharmacist if you are allergic to it; or if you have any other||
1714|083|P|allergies. This product may contain inactive ingredients, which||
1714|084|P|can cause allergic reactions or other problems. Talk to your||
1714|085|P|pharmacist for more details.||
1714|086|P|   Before using this medication, tell your doctor or pharmacist||
1714|087|P|your medical history.||
1714|088|P|   Before having surgery, tell your doctor or dentist about all||
1714|089|P|the products you use (including prescription drugs,||
1714|090|P|nonprescription drugs, and herbal products).||
1714|091|P|   During pregnancy, this medication should be used only when||
1714|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
1714|093|P|   It is unknown if this medication passes into breast milk.||
1714|094|P|Consult your doctor before breastfeeding.||
1714|095|B|||
1714|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1714|097|I|medications work or increase your risk for serious side effects.||
1714|098|I|This document does not contain all possible drug interactions.||
1714|099|I|Keep a list of all the products you use (including||
1714|100|I|prescription/nonprescription drugs and herbal products) and share||
1714|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
1714|102|I|the dosage of any medicines without your doctor's approval.||
1714|103|B|||
1714|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1714|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1714|106|O|poison control center right away. US residents can call||
1714|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1714|108|B|||
1714|109|N|NOTES:  Do not share this medication with others.||
1714|110|N|   Lab and/or medical tests (such as LDL cholesterol levels)||
1714|111|N|should be done while you are using this medication. Keep all||
1714|112|N|medical and lab appointments.||
1714|113|B|||
1714|114|D|MISSED DOSE:  If you are using this medication every 2 weeks and||
1714|115|D|miss a dose, use it as soon as you remember. If it is more than 7||
1714|116|D|days after the missed dose, skip the missed dose. Use your next||
1714|117|D|dose at the regular time. Do not double the dose to catch up.||
1714|118|D|   If you are using this medication once a month and miss a dose,||
1714|119|D|use it as soon as you remember if it is within 7 days after the||
1714|120|D|missed dose, then use your next dose at the regular time. If it||
1714|121|D|is more than 7 days after the missed dose, use it as soon as you||
1714|122|D|remember and start a new monthly schedule based on this date. Do||
1714|123|D|not double the dose to catch up.||
1714|124|B|||
1714|125|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1714|126|R|medication in original carton to protect from light. This||
1714|127|R|medication may also be stored at room temperature if needed. If||
1714|128|R|the medication is stored at room temperature, discard after 30||
1714|129|R|days. Keep all medications away from children and pets.||
1714|130|R|   Do not flush medications down the toilet or pour them into a||
1714|131|R|drain unless instructed to do so. Properly discard this product||
1714|132|R|when it is expired or no longer needed. Consult your pharmacist||
1714|133|R|or local waste disposal company.||
1714|134|B|||
1714|135|A|Information last revised October 2024.||
1714|136|A|Copyright(c) 2025 First Databank, Inc.||
1714|137|B|||
1715|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1715|002|Z|does NOT have all possible information about this product. This||
1715|003|Z|information does not assure that this product is safe, effective,||
1715|004|Z|or appropriate for you. This information is not individual||
1715|005|Z|medical advice and does not substitute for the advice of your||
1715|006|Z|health care professional. Always ask your health care||
1715|007|Z|professional for complete information about this product and your||
1715|008|Z|specific health needs.||
1715|009|B|||
1715|010|T|LUMACAFTOR/IVACAFTOR - ORAL||
1715|011|F|(LOO-ma-KAF-tor/EYE-va-KAF-tor)||
1715|012|B|||
1715|013|C|COMMON BRAND NAME(S): Orkambi||
1715|014|B|||
1715|015|U|USES:  This medication is a combination of 2 medications:||
1715|016|U|lumacaftor and ivacaftor. It is used to treat cystic fibrosis in||
1715|017|U|certain people (those with 2 copies of an abnormal "CFTR" gene).||
1715|018|U|It may help to improve breathing, reduce the risk of lung||
1715|019|U|infections, and improve weight gain.||
1715|020|B|||
1715|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1715|022|H|from your pharmacist before you start taking lumacaftor/ivacaftor||
1715|023|H|and each time you get a refill. If you have any questions, ask||
1715|024|H|your doctor or pharmacist.||
1715|025|H|   Take this medication by mouth as directed by your doctor,||
1715|026|H|usually twice daily (12 hours apart). Eat a fat-containing meal||
1715|027|H|or snack just before or just after taking this medication.||
1715|028|H|Examples include eggs, avocados, nuts, butter, peanut butter,||
1715|029|H|cheese pizza, or whole-milk dairy products (such as whole milk,||
1715|030|H|cheese, yogurt).||
1715|031|H|   If you are taking the granules form of this medication, gently||
1715|032|H|shake the packet before use. Open the packet and carefully pour||
1715|033|H|the contents into a small bowl with 1 teaspoonful (5 milliliters)||
1715|034|H|of soft food or liquid (such as yogurt, applesauce, pudding,||
1715|035|H|milk, or juice). The soft food or liquid should be at or below||
1715|036|H|room temperature. After mixing, take all of the mixture within 1||
1715|037|H|hour. Be sure to eat a fat-containing food as directed.||
1715|038|H|   The dosage is based on your age, medical condition, response||
1715|039|H|to treatment, and other medications you may be taking. Children's||
1715|040|H|dosage may also be based on weight. Be sure to tell your doctor||
1715|041|H|and pharmacist about all the products you use (including||
1715|042|H|prescription drugs, nonprescription drugs, and herbal products).||
1715|043|H|   Use this medication regularly to get the most benefit from it.||
1715|044|H|To help you remember, take it at the same times each day. If your||
1715|045|H|dose is temporarily stopped for longer than 1 week, ask your||
1715|046|H|doctor for specific directions to restart this medication. If you||
1715|047|H|are taking certain other medications, you may be directed to||
1715|048|H|restart at a lower dose for the first week.||
1715|049|H|   Tell your doctor if your condition does not get better or if||
1715|050|H|it gets worse.||
1715|051|B|||
1715|052|S|SIDE EFFECTS:  Nausea, gas, or diarrhea may occur. If any of||
1715|053|S|these effects last or get worse, tell your doctor or pharmacist||
1715|054|S|promptly.||
1715|055|S|   Remember that this medication has been prescribed because your||
1715|056|S|doctor has judged that the benefit to you is greater than the||
1715|057|S|risk of side effects. Many people using this medication do not||
1715|058|S|have serious side effects.||
1715|059|S|   This medication may raise your blood pressure. Check your||
1715|060|S|blood pressure regularly and tell your doctor if the results are||
1715|061|S|high.||
1715|062|S|   This medication may rarely cause increased pressure around the||
1715|063|S|brain (intracranial hypertension-IH). Get medical help right away||
1715|064|S|if any of these very serious side effects occur: headache that is||
1715|065|S|severe or doesn't go away, vision changes (such as blurred/double||
1715|066|S|vision, decreased vision).||
1715|067|S|   This medication may rarely cause serious liver disease. Get||
1715|068|S|medical help right away if you have any symptoms of liver damage,||
1715|069|S|including: nausea/vomiting that doesn't stop, loss of appetite,||
1715|070|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
1715|071|S|   Some people who already have severe lung disease may develop||
1715|072|S|breathing problems after starting this medication. Get medical||
1715|073|S|help right away if you have: chest pain, shortness of breath.||
1715|074|S|   Lumacaftor/ivacaftor can commonly cause a rash that is usually||
1715|075|S|not serious. However, you may not be able to tell it apart from a||
1715|076|S|rare rash that could be a sign of a severe reaction. Tell your||
1715|077|S|doctor right away if you develop any rash.||
1715|078|S|   A very serious allergic reaction to this drug is rare.||
1715|079|S|However, get medical help right away if you notice any symptoms||
1715|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1715|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1715|082|S|breathing.||
1715|083|S|   This is not a complete list of possible side effects. If you||
1715|084|S|notice other effects not listed above, contact your doctor or||
1715|085|S|pharmacist.||
1715|086|S|   In the US -||
1715|087|S|   Call your doctor for medical advice about side effects. You||
1715|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1715|089|S|www.fda.gov/medwatch.||
1715|090|S|   In Canada - Call your doctor for medical advice about side||
1715|091|S|effects. You may report side effects to Health Canada at||
1715|092|S|1-866-234-2345.||
1715|093|B|||
1715|094|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1715|095|P|pharmacist if you are allergic to lumacaftor or ivacaftor; or if||
1715|096|P|you have any other allergies. This product may contain inactive||
1715|097|P|ingredients, which can cause allergic reactions or other||
1715|098|P|problems. Talk to your pharmacist for more details.||
1715|099|P|   Before using this medication, tell your doctor or pharmacist||
1715|100|P|your medical history, especially of: liver disease.||
1715|101|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1715|102|P|can make you more dizzy. Do not drive, use machinery, or do||
1715|103|P|anything that needs alertness until you can do it safely. Limit||
1715|104|P|alcoholic beverages. Talk to your doctor if you are using||
1715|105|P|marijuana (cannabis).||
1715|106|P|   Before having surgery, tell your doctor or dentist about all||
1715|107|P|the products you use (including prescription drugs,||
1715|108|P|nonprescription drugs, and herbal products).||
1715|109|P|   During pregnancy, this medication should be used only when||
1715|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
1715|111|P|   This medication passes into breast milk. Consult your doctor||
1715|112|P|before breastfeeding.||
1715|113|B|||
1715|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1715|115|I|medications work or increase your risk for serious side effects.||
1715|116|I|This document does not contain all possible drug interactions.||
1715|117|I|Keep a list of all the products you use (including||
1715|118|I|prescription/nonprescription drugs and herbal products) and share||
1715|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
1715|120|I|the dosage of any medicines without your doctor's approval.||
1715|121|I|   Other medications can affect the removal of||
1715|122|I|lumacaftor/ivacaftor from your body, which may affect how this||
1715|123|I|medication works. Examples include mifepristone, rifamycins (such||
1715|124|I|as rifampin, rifabutin), drugs for seizures (such as||
1715|125|I|carbamazepine, phenytoin), St. John's wort, among others.||
1715|126|I|   This medication can speed up the removal of other medications||
1715|127|I|from your body, which may affect how they work. Examples of||
1715|128|I|affected drugs include certain azole antifungals (such as||
1715|129|I|isavuconazonium, voriconazole), macrolide antibiotics (such as||
1715|130|I|erythromycin, clarithromycin), certain drugs that weaken the||
1715|131|I|immune system (such as cyclosporine, everolimus, tacrolimus),||
1715|132|I|nirmatrelvir, pacritinib, certain sedatives (such as midazolam,||
1715|133|I|triazolam), warfarin, among others.||
1715|134|I|   This medication may decrease the effectiveness of hormonal||
1715|135|I|birth control such as pills, patch, or ring. This could cause||
1715|136|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1715|137|I|use reliable backup birth control methods while using this||
1715|138|I|medication. Also tell your doctor if you have any new spotting or||
1715|139|I|breakthrough bleeding, because these may be signs that your birth||
1715|140|I|control is not working well.||
1715|141|B|||
1715|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1715|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1715|144|O|poison control center right away. US residents can call||
1715|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1715|146|B|||
1715|147|N|NOTES:  Do not share this medication with others.||
1715|148|N|   Lab and/or medical tests (such as CFTR gene testing,||
1715|149|N|liver/lung function, eye exams) will be done before you start||
1715|150|N|taking this medication and while you are taking it. Keep all||
1715|151|N|medical and lab appointments.||
1715|152|B|||
1715|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1715|154|D|remember. If it is less than 6 hours before the next dose, skip||
1715|155|D|the missed dose. Take your next dose at the regular time. Do not||
1715|156|D|double the dose to catch up.||
1715|157|B|||
1715|158|R|STORAGE:  Store at room temperature away from light and moisture.||
1715|159|R|Do not store in the bathroom. Keep all medications away from||
1715|160|R|children and pets.||
1715|161|R|   Do not flush medications down the toilet or pour them into a||
1715|162|R|drain unless instructed to do so. Properly discard this product||
1715|163|R|when it is expired or no longer needed. Consult your pharmacist||
1715|164|R|or local waste disposal company.||
1715|165|B|||
1715|166|A|Information last revised September 2025.||
1715|167|A|Copyright(c) 2025 First Databank, Inc.||
1715|168|B|||
1718|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1718|002|Z|does NOT have all possible information about this product. This||
1718|003|Z|information does not assure that this product is safe, effective,||
1718|004|Z|or appropriate for you. This information is not individual||
1718|005|Z|medical advice and does not substitute for the advice of your||
1718|006|Z|health care professional. Always ask your health care||
1718|007|Z|professional for complete information about this product and your||
1718|008|Z|specific health needs.||
1718|009|B|||
1718|010|T|ASPIRIN/CAFFEINE - ORAL||
1718|011|F|(AS-pir-in/KAF-een)||
1718|012|B|||
1718|013|C|COMMON BRAND NAME(S): Anacin||
1718|014|B|||
1718|015|U|USES:  This medication is a combination of aspirin and caffeine.||
1718|016|U|It is used to treat minor aches and pains due to various||
1718|017|U|conditions such as headache, toothache, menstrual cramps, or||
1718|018|U|muscle aches.||
1718|019|U|   Aspirin is known as a salicylate and a nonsteroidal||
1718|020|U|anti-inflammatory drug (NSAID). It relieves pain and decreases||
1718|021|U|swelling. Caffeine may help increase the effects of aspirin on||
1718|022|U|pain.||
1718|023|B|||
1718|024|H|HOW TO USE:  If you are taking the over-the-counter product to||
1718|025|H|self-treat, read and follow all directions on the product package||
1718|026|H|before taking this medication. If you have any questions, consult||
1718|027|H|your pharmacist. If your doctor has prescribed this medication,||
1718|028|H|take it as directed.||
1718|029|H|   Take this medication by mouth as directed by your doctor,||
1718|030|H|usually every 6 hours. If you have stomach upset while taking||
1718|031|H|this medication, take it with food or milk. Take this medication||
1718|032|H|with a full glass of water (8 ounces/240 milliliters) unless your||
1718|033|H|doctor directs you otherwise. Do not lie down for at least 10||
1718|034|H|minutes after taking this medication.||
1718|035|H|   If you are using the powder packets, dissolve the powder on||
1718|036|H|tongue and follow with a full glass of water.||
1718|037|H|   The dosage is based on your medical condition and response to||
1718|038|H|treatment. Do not increase your dose or use this drug more often||
1718|039|H|or for longer than directed. Your condition will not improve any||
1718|040|H|faster, and your risk of side effects will increase. Use the||
1718|041|H|smallest effective dose.||
1718|042|H|   This medication contains caffeine. Avoid drinking large||
1718|043|H|amounts of beverages containing caffeine (coffee, tea, colas),||
1718|044|H|eating large amounts of chocolate, or taking nonprescription||
1718|045|H|products that contain caffeine.||
1718|046|H|   If you are taking this medication for self-treatment of||
1718|047|H|headache, get medical help right away if you also have trouble||
1718|048|H|speaking, weakness on one side of the body, or sudden vision||
1718|049|H|changes. Before using this drug, consult a doctor or pharmacist||
1718|050|H|if you have headaches caused by head injury, coughing, or||
1718|051|H|bending, or if you have a headache with fever, stiff neck, and||
1718|052|H|vomiting that is severe or does not go away.||
1718|053|H|   If you are taking this medication "as needed" (not on a||
1718|054|H|regular schedule), remember that pain medications work best if||
1718|055|H|they are used as the first signs of pain occur. If you wait until||
1718|056|H|the pain has worsened, the medicine may not work as well.||
1718|057|H|   You should not take this medication for self-treatment of pain||
1718|058|H|for longer than 10 days. You should not use this drug to||
1718|059|H|self-treat a fever that lasts longer than 3 days. In these cases,||
1718|060|H|consult a doctor because you may have a more serious condition.||
1718|061|H|Tell your doctor promptly if you develop ringing in the ears or||
1718|062|H|difficulty hearing.||
1718|063|H|   If your condition lasts or gets worse (such as new or unusual||
1718|064|H|symptoms, redness/swelling of the painful area, pain/fever that||
1718|065|H|does not go away or gets worse) or if you think you may have a||
1718|066|H|serious medical problem, get medical help right away.||
1718|067|B|||
1718|068|S|SIDE EFFECTS:  Nausea, vomiting, stomach upset, heartburn,||
1718|069|S|trouble sleeping, or increased urination may occur. If any of||
1718|070|S|these effects last or get worse, tell your doctor or pharmacist||
1718|071|S|promptly.||
1718|072|S|   If your doctor has directed you to use this medication,||
1718|073|S|remember that your doctor has judged that the benefit to you is||
1718|074|S|greater than the risk of side effects. Many people using this||
1718|075|S|medication do not have serious side effects.||
1718|076|S|   Tell your doctor right away if you have any serious side||
1718|077|S|effects, including: mental/mood changes (such as nervousness,||
1718|078|S|agitation), shaking (tremor), fast/pounding/irregular heartbeat,||
1718|079|S|hearing changes (such as ringing in the ears, difficulty||
1718|080|S|hearing), easy bleeding/bruising, unusual tiredness, signs of||
1718|081|S|kidney problems (such as change in the amount of urine),||
1718|082|S|nausea/vomiting that is severe or doesn't go away, yellowing||
1718|083|S|eyes/skin, dark urine.||
1718|084|S|   This drug may rarely cause serious bleeding from the||
1718|085|S|stomach/intestine or other areas of the body. If you notice any||
1718|086|S|of the following rare but very serious side effects, get medical||
1718|087|S|help right away: black/tarry stools, stomach/abdominal pain that||
1718|088|S|is severe or doesn't go away, vomit that looks like coffee||
1718|089|S|grounds, trouble speaking, weakness on one side of the body,||
1718|090|S|sudden vision changes or severe headache.||
1718|091|S|   A very serious allergic reaction to this drug is rare.||
1718|092|S|However, get medical help right away if you notice any symptoms||
1718|093|S|of a serious allergic reaction, including: fever, swollen lymph||
1718|094|S|nodes, rash, itching/swelling (especially of the||
1718|095|S|face/tongue/throat), severe dizziness, trouble breathing.||
1718|096|S|   This is not a complete list of possible side effects. If you||
1718|097|S|notice other effects not listed above, contact your doctor or||
1718|098|S|pharmacist.||
1718|099|S|   In the US -||
1718|100|S|   Call your doctor for medical advice about side effects. You||
1718|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1718|102|S|www.fda.gov/medwatch.||
1718|103|S|   In Canada - Call your doctor for medical advice about side||
1718|104|S|effects. You may report side effects to Health Canada at||
1718|105|S|1-866-234-2345.||
1718|106|B|||
1718|107|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1718|108|P|pharmacist if you are allergic to caffeine, or aspirin; or to||
1718|109|P|other nonsteroidal anti-inflammatory drugs-NSAIDs (such as||
1718|110|P|ibuprofen, naproxen, celecoxib); or to other salicylates (such as||
1718|111|P|choline salicylate); or if you have any other allergies. This||
1718|112|P|product may contain inactive ingredients, which can cause||
1718|113|P|allergic reactions or other problems. Talk to your pharmacist for||
1718|114|P|more details.||
1718|115|P|   Before using this medication, tell your doctor or pharmacist||
1718|116|P|your medical history, especially of: stomach problems (such as||
1718|117|P|ulcers, heartburn, stomach pain), asthma (including a history of||
1718|118|P|worsening breathing after taking aspirin or other NSAIDs),||
1718|119|P|growths in the nose (nasal polyps), bleeding/blood clotting||
1718|120|P|problems (such as hemophilia, low platelet counts), gout, heart||
1718|121|P|problems (such as fast/irregular heartbeat, heart failure, heart||
1718|122|P|attack), high blood pressure, kidney disease, liver disease,||
1718|123|P|certain enzyme deficiencies (such as pyruvate kinase or G6PD||
1718|124|P|deficiency).||
1718|125|P|   Before having surgery or certain medical procedures (such as a||
1718|126|P|heart stress test or a procedure to restore a normal heart rhythm||
1718|127|P|if you have an unusually fast heartbeat), tell your doctor or||
1718|128|P|dentist that you use this medication and about all the products||
1718|129|P|you use (including prescription drugs, nonprescription drugs, and||
1718|130|P|herbal products).||
1718|131|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1718|132|P|and tobacco, especially when combined with this medicine, may||
1718|133|P|increase your risk for stomach bleeding. Limit alcohol and stop||
1718|134|P|smoking. Consult your doctor or pharmacist for more information.||
1718|135|P|   This drug contains aspirin. Children and teenagers younger||
1718|136|P|than 18 years should not take aspirin if they have chickenpox,||
1718|137|P|flu, or any undiagnosed illness or if they have recently received||
1718|138|P|a vaccine. In these cases, taking aspirin increases the risk of||
1718|139|P|Reye's syndrome, a rare but serious illness.||
1718|140|P|   Older adults may be more sensitive to the side effects of this||
1718|141|P|drug, especially stomach ulcer/bleeding, or trouble sleeping.||
1718|142|P|   Before using this medication, women of childbearing age should||
1718|143|P|talk with their doctor(s) about the benefits and risks. Tell your||
1718|144|P|doctor if you are pregnant or if you plan to become pregnant.||
1718|145|P|This medication may harm an unborn baby and cause problems with||
1718|146|P|normal labor/delivery. It is not recommended for use in pregnancy||
1718|147|P|from 20 weeks until delivery. If your doctor decides that you||
1718|148|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1718|149|P|you should use the lowest effective dose for the shortest||
1718|150|P|possible time. You should not use this medication after 30 weeks||
1718|151|P|of pregnancy.||
1718|152|P|   This medication passes into breast milk and may harm a nursing||
1718|153|P|infant. Breastfeeding is not recommended while using this||
1718|154|P|medication. Consult your doctor before breastfeeding.||
1718|155|B|||
1718|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1718|157|I|medications work or increase your risk for serious side effects.||
1718|158|I|This document does not contain all possible drug interactions.||
1718|159|I|Keep a list of all the products you use (including||
1718|160|I|prescription/nonprescription drugs and herbal products) and share||
1718|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
1718|162|I|the dosage of any medicines without your doctor's approval.||
1718|163|I|   Some products that may interact with this drug are:||
1718|164|I|acetazolamide, corticosteroids (such as prednisone),||
1718|165|I|dichlorphenamide, methotrexate, mifepristone, valproic acid,||
1718|166|I|vemurafenib, herbal medications (such as ginkgo biloba).||
1718|167|I|   Before using this product, consult your doctor if you have||
1718|168|I|recently received certain live vaccines (such as varicella||
1718|169|I|vaccine, live flu vaccine).||
1718|170|I|   This medication may increase the risk of bleeding when taken||
1718|171|I|with other drugs that also may cause bleeding. Examples include||
1718|172|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1718|173|I|dabigatran/enoxaparin/warfarin, among others.||
1718|174|I|   Check all prescription and nonprescription medicine labels||
1718|175|I|carefully since many medications contain pain relievers/fever||
1718|176|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
1718|177|I|naproxen). These drugs are similar to this medication and may||
1718|178|I|increase your risk of side effects if taken together.||
1718|179|I|   Daily use of NSAIDs (such as ibuprofen) may decrease aspirin's||
1718|180|I|ability to prevent heart attack/stroke. If you are taking||
1718|181|I|low-dose aspirin for prevention of heart attack/stroke, consult||
1718|182|I|your doctor or pharmacist for more details and to discuss other||
1718|183|I|possible treatments (such as acetaminophen) for your pain/fever.||
1718|184|I|   This medication may interfere with certain medical/lab tests||
1718|185|I|(such as dipyridamole-thallium imaging tests, certain urine||
1718|186|I|tests), possibly causing false test results. Make sure lab||
1718|187|I|personnel and all your doctors know you use this drug.||
1718|188|B|||
1718|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1718|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1718|191|O|poison control center right away. US residents can call||
1718|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1718|193|O|Symptoms of overdose may include: burning pain in the||
1718|194|O|throat/stomach, confusion, mental/mood changes, fainting,||
1718|195|O|weakness, ringing in the ears, fever, rapid breathing, change in||
1718|196|O|the amount of urine, seizures, loss of consciousness.||
1718|197|B|||
1718|198|N|NOTES:  Do not share this medication with others.||
1718|199|N|   If you are taking this medication for a long time, lab and/or||
1718|200|N|medical tests (such as liver/kidney function, blood count) may be||
1718|201|N|done to check for side effects. Keep all medical and lab||
1718|202|N|appointments. Consult your doctor for more details.||
1718|203|N|   Because this product contains caffeine, taking it close to||
1718|204|N|bedtime may give you trouble falling asleep. Limit the use of||
1718|205|N|caffeine-containing medications, foods, or beverages while taking||
1718|206|N|this product. If you take too much caffeine, you may become||
1718|207|N|nervous or irritable, have trouble sleeping, or have fast||
1718|208|N|heartbeat.||
1718|209|N|   If you are taking this product for headaches, it is best to||
1718|210|N|avoid certain foods that may trigger your headaches. Lifestyle||
1718|211|N|changes such as stress reduction programs, exercise, and dietary||
1718|212|N|changes may help prevent headaches. Talk to your doctor or||
1718|213|N|pharmacist about lifestyle changes that might benefit you.||
1718|214|B|||
1718|215|D|MISSED DOSE:  If you are taking this medication on a regular||
1718|216|D|schedule and miss a dose, take it as soon as you remember. If it||
1718|217|D|is near the time of the next dose, skip the missed dose. Take||
1718|218|D|your next dose at the regular time. Do not double the dose to||
1718|219|D|catch up.||
1718|220|B|||
1718|221|R|STORAGE:  Store at room temperature away from light and moisture.||
1718|222|R|Do not store in the bathroom. Keep all medications away from||
1718|223|R|children and pets.||
1718|224|R|   Do not flush medications down the toilet or pour them into a||
1718|225|R|drain unless instructed to do so. Properly discard this product||
1718|226|R|when it is expired or no longer needed. Consult your pharmacist||
1718|227|R|or local waste disposal company.||
1718|228|B|||
1718|229|A|Information last revised November 2025.||
1718|230|A|Copyright(c) 2025 First Databank, Inc.||
1718|231|B|||
1719|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1719|002|Z|does NOT have all possible information about this product. This||
1719|003|Z|information does not assure that this product is safe, effective,||
1719|004|Z|or appropriate for you. This information is not individual||
1719|005|Z|medical advice and does not substitute for the advice of your||
1719|006|Z|health care professional. Always ask your health care||
1719|007|Z|professional for complete information about this product and your||
1719|008|Z|specific health needs.||
1719|009|B|||
1719|010|T|AZELAIC ACID FOAM - TOPICAL||
1719|011|F|(ay-ze-LAY-ik AS-id)||
1719|012|B|||
1719|013|C|COMMON BRAND NAME(S): Finacea||
1719|014|B|||
1719|015|U|USES:  This medication is used to treat a certain skin disorder||
1719|016|U|known as rosacea, a type of adult acne. It helps to decrease||
1719|017|U|redness, swelling, and the number of pimples caused by rosacea.||
1719|018|B|||
1719|019|H|HOW TO USE:  Apply this medication on your face as directed by||
1719|020|H|your doctor, usually twice daily. To avoid irritation, avoid||
1719|021|H|contact with your eyes or inside the nose or mouth. If you||
1719|022|H|accidentally get this medication in your eyes, flush well with||
1719|023|H|cool water. Call your doctor if eye irritation does not go away.||
1719|024|H|   Before use, wash the affected area with a mild soap or||
1719|025|H|soap-free cleanser and pat dry. Avoid using other skin care||
1719|026|H|products that may irritate your skin, such as astringents,||
1719|027|H|abrasives, tinctures, cleansers that contain alcohol, and||
1719|028|H|products that cause skin peeling. Shake the container well before||
1719|029|H|each use. Use your fingers to apply a thin layer of medication||
1719|030|H|over your whole face (cheeks, chin, forehead, and nose) and||
1719|031|H|gently massage the foam into your skin. Wash your hands after||
1719|032|H|each use. Makeup may be applied after the medication has dried.||
1719|033|H|   Do not use any dressing or covering on the treated area unless||
1719|034|H|directed by your doctor.||
1719|035|H|   Use this medication regularly to get the most benefit from it.||
1719|036|H|To help you remember, use it at the same times each day. Do not||
1719|037|H|use more of this medication or use this drug more often or for||
1719|038|H|longer than prescribed. Your skin will not improve any faster,||
1719|039|H|and your risk of side effects will increase.||
1719|040|H|   Tell your doctor if your condition does not get better after||
1719|041|H|12 weeks or if it gets worse.||
1719|042|B|||
1719|043|S|SIDE EFFECTS:  Skin burning, stinging, tingling, or itching may||
1719|044|S|occur. If any of these effects last or get worse, tell your||
1719|045|S|doctor or pharmacist promptly.||
1719|046|S|   Remember that this medication has been prescribed because your||
1719|047|S|doctor has judged that the benefit to you is greater than the||
1719|048|S|risk of side effects. Many people using this medication do not||
1719|049|S|have serious side effects.||
1719|050|S|   Rarely, some people have had unusual loss of skin color||
1719|051|S|(hypopigmentation) after using this medication. This side effect||
1719|052|S|may be easier to see in people with dark skin color. Tell your||
1719|053|S|doctor right away if you notice this side effect.||
1719|054|S|   A very serious allergic reaction to this drug is rare.||
1719|055|S|However, get medical help right away if you notice any symptoms||
1719|056|S|of a serious allergic reaction, including: rash, itching/swelling||
1719|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1719|058|S|breathing.||
1719|059|S|   This is not a complete list of possible side effects. If you||
1719|060|S|notice other effects not listed above, contact your doctor or||
1719|061|S|pharmacist.||
1719|062|S|   In the US -||
1719|063|S|   Call your doctor for medical advice about side effects. You||
1719|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1719|065|S|www.fda.gov/medwatch.||
1719|066|S|   In Canada - Call your doctor for medical advice about side||
1719|067|S|effects. You may report side effects to Health Canada at||
1719|068|S|1-866-234-2345.||
1719|069|B|||
1719|070|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1719|071|P|pharmacist if you are allergic to it; or if you have any other||
1719|072|P|allergies. This product may contain inactive ingredients, which||
1719|073|P|can cause allergic reactions or other problems. Talk to your||
1719|074|P|pharmacist for more details.||
1719|075|P|   Before using this medication, tell your doctor or pharmacist||
1719|076|P|your medical history.||
1719|077|P|   Before having surgery, tell your doctor or dentist about all||
1719|078|P|the products you use (including prescription drugs,||
1719|079|P|nonprescription drugs, and herbal products).||
1719|080|P|   During pregnancy, this medication should be used only when||
1719|081|P|clearly needed. Discuss the risks and benefits with your doctor.||
1719|082|P|   This medication may pass into breast milk, but is unlikely to||
1719|083|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1719|084|B|||
1719|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1719|086|I|medications work or increase your risk for serious side effects.||
1719|087|I|This document does not contain all possible drug interactions.||
1719|088|I|Keep a list of all the products you use (including||
1719|089|I|prescription/nonprescription drugs and herbal products) and share||
1719|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
1719|091|I|the dosage of any medicines without your doctor's approval.||
1719|092|B|||
1719|093|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1719|094|O|has overdosed and has serious symptoms such as passing out or||
1719|095|O|trouble breathing, call 911. Otherwise, call a poison control||
1719|096|O|center right away. US residents can call 1-800-222-1222. Canada||
1719|097|O|residents can call 1-844-764-7669.||
1719|098|B|||
1719|099|N|NOTES:  Do not share this medication with others.||
1719|100|N|   To help manage rosacea, avoid foods or liquids that may bring||
1719|101|N|on redness, flushing, or blushing of the skin (such as spicy||
1719|102|N|foods, alcohol, hot drinks).||
1719|103|B|||
1719|104|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1719|105|D|If it is near the time of the next dose, skip the missed dose.||
1719|106|D|Use your next dose at the regular time. Do not double the dose to||
1719|107|D|catch up.||
1719|108|B|||
1719|109|R|STORAGE:  Store at room temperature. This product is flammable||
1719|110|R|and the contents under pressure. Keep it away from heat and open||
1719|111|R|flame. Do not puncture or burn the container. Once the container||
1719|112|R|is opened, this medication expires after 8 weeks. Keep all||
1719|113|R|medications away from children and pets.||
1719|114|R|   Do not flush medications down the toilet or pour them into a||
1719|115|R|drain unless instructed to do so. Properly discard this product||
1719|116|R|when it is expired or no longer needed. Consult your pharmacist||
1719|117|R|or local waste disposal company.||
1719|118|B|||
1719|119|A|Information last revised July 2025.||
1719|120|A|Copyright(c) 2025 First Databank, Inc.||
1719|121|B|||
1720|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1720|002|Z|does NOT have all possible information about this product. This||
1720|003|Z|information does not assure that this product is safe, effective,||
1720|004|Z|or appropriate for you. This information is not individual||
1720|005|Z|medical advice and does not substitute for the advice of your||
1720|006|Z|health care professional. Always ask your health care||
1720|007|Z|professional for complete information about this product and your||
1720|008|Z|specific health needs.||
1720|009|B|||
1720|010|T|CAPSAICIN/MENTHOL PATCH - TOPICAL||
1720|011|F|(kap-SAY-i-sin/MEN-thol)||
1720|012|B|||
1720|013|C|COMMON BRAND NAME(S): Medrox, Relyyt, Salonpas, Sinelee||
1720|014|B|||
1720|015|U|USES:  This medication is used to treat minor aches and pains of||
1720|016|U|the muscles/joints (such as arthritis, backache, sprains).||
1720|017|U|Capsaicin works by decreasing a certain natural substance in your||
1720|018|U|body (substance P) that helps pass pain signals to the brain.||
1720|019|U|Menthol works by causing the skin to feel cool and then warm.||
1720|020|U|These feelings on the skin distract you from feeling the||
1720|021|U|aches/pains deeper in your muscles and joints.||
1720|022|B|||
1720|023|V|OTHER USES:  This section contains uses of this drug that are not||
1720|024|V|listed in the approved professional labeling for the drug but||
1720|025|V|that may be prescribed by your health care professional. Use this||
1720|026|V|drug for a condition that is listed in this section only if it||
1720|027|V|has been so prescribed by your health care professional.||
1720|028|V|   This drug may also be used for nerve pain.||
1720|029|B|||
1720|030|H|HOW TO USE:  Use this medication on the skin only. Clean and dry||
1720|031|H|the affected area. Remove the backing from the patch and apply||
1720|032|H|the patch to the affected area. Do not apply this medication to||
1720|033|H|skin that is injured or irritated (such as skin that is cut,||
1720|034|H|scraped, sunburned, infected, or has a rash). Leave the patch on||
1720|035|H|the affected area for up to 8 hours. Use this medication as||
1720|036|H|directed by your doctor or follow all directions on the product||
1720|037|H|package. If you have any questions, talk to your doctor or||
1720|038|H|pharmacist.||
1720|039|H|   Take the patch off at least 1 hour before bathing and do not||
1720|040|H|apply the patch right away after bathing. Do not bandage or wrap||
1720|041|H|the area where the patch is applied unless directed to do so by||
1720|042|H|the doctor. Do not use a heating pad on the patch. Doing so may||
1720|043|H|increase the risk of side effects.||
1720|044|H|   Wash your hands well after handling the patch. Avoid getting||
1720|045|H|this medication in your eyes, mouth, nostrils, or genitals. If||
1720|046|H|you do get the medication in those areas, flush with plenty of||
1720|047|H|water.||
1720|048|H|   After removing each patch, fold the used patch with the sticky||
1720|049|H|sides together, and throw away in the trash away from children||
1720|050|H|and pets.||
1720|051|H|   Tell your doctor if your condition lasts for more than 7 days,||
1720|052|H|if it gets worse, or if it keeps returning. If you think you may||
1720|053|H|have a serious medical problem, get medical help right away.||
1720|054|B|||
1720|055|S|SIDE EFFECTS:  Redness, mild itching, or flaking skin on the||
1720|056|S|application site may occur. If any of these effects last or get||
1720|057|S|worse, tell your doctor or pharmacist promptly.||
1720|058|S|   Remember that this medication has been prescribed because your||
1720|059|S|doctor has judged that the benefit to you is greater than the||
1720|060|S|risk of side effects. Many people using this medication do not||
1720|061|S|have serious side effects.||
1720|062|S|   Stop using this medication and tell your doctor right away if||
1720|063|S|you have any serious side effects, including: blistering/swelling||
1720|064|S|at the application site, increased/unusual pain at the||
1720|065|S|application site.||
1720|066|S|   A very serious allergic reaction to this drug is rare.||
1720|067|S|However, get medical help right away if you notice any symptoms||
1720|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1720|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1720|070|S|breathing.||
1720|071|S|   This is not a complete list of possible side effects. If you||
1720|072|S|notice other effects not listed above, contact your doctor or||
1720|073|S|pharmacist.||
1720|074|S|   In the US -||
1720|075|S|   Call your doctor for medical advice about side effects. You||
1720|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1720|077|S|www.fda.gov/medwatch.||
1720|078|S|   In Canada - Call your doctor for medical advice about side||
1720|079|S|effects. You may report side effects to Health Canada at||
1720|080|S|1-866-234-2345.||
1720|081|B|||
1720|082|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1720|083|P|pharmacist if you are allergic to capsaicin or menthol; or to||
1720|084|P|zucapsaicin; or to hot peppers (from the Capsicum family); or if||
1720|085|P|you have any other allergies. This product may contain inactive||
1720|086|P|ingredients, which can cause allergic reactions or other||
1720|087|P|problems. Talk to your pharmacist for more details.||
1720|088|P|   Before using this medication, tell your doctor or pharmacist||
1720|089|P|your medical history.||
1720|090|P|   Before having surgery, tell your doctor or dentist about all||
1720|091|P|the products you use (including prescription drugs,||
1720|092|P|nonprescription drugs, and herbal products).||
1720|093|P|   If you are going to have an MRI test, tell testing personnel||
1720|094|P|if you are using this patch. Some patches may contain metals that||
1720|095|P|can cause serious burns during an MRI. Ask your doctor whether||
1720|096|P|you will need to remove your patch before the test and apply a||
1720|097|P|new patch afterward, and how to do so properly.||
1720|098|P|   During pregnancy, this medication should be used only when||
1720|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
1720|100|P|   It is unknown if this medication passes into breast milk.||
1720|101|P|Consult your doctor before breastfeeding.||
1720|102|B|||
1720|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1720|104|I|medications work or increase your risk for serious side effects.||
1720|105|I|This document does not contain all possible drug interactions.||
1720|106|I|Keep a list of all the products you use (including||
1720|107|I|prescription/nonprescription drugs and herbal products) and share||
1720|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
1720|109|I|the dosage of any medicines without your doctor's approval.||
1720|110|I|   Capsaicin is very similar to zucapsaicin. Do not use||
1720|111|I|medications containing zucapsaicin while using capsaicin.||
1720|112|B|||
1720|113|O|OVERDOSE:  This medication patch may be harmful if chewed or||
1720|114|O|swallowed. If someone has overdosed, remove the patch if||
1720|115|O|possible. For serious symptoms such as passing out or trouble||
1720|116|O|breathing, call 911. Otherwise, call a poison control center||
1720|117|O|right away. US residents can call 1-800-222-1222. Canada||
1720|118|O|residents can call 1-844-764-7669.||
1720|119|B|||
1720|120|N|NOTES:  Do not share this medication with others.||
1720|121|N|   Keep all medical and lab appointments.||
1720|122|B|||
1720|123|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1720|124|D|If it is near the time of the next dose, skip the missed dose.||
1720|125|D|Use your next dose at the regular time. Do not double the dose to||
1720|126|D|catch up.||
1720|127|B|||
1720|128|R|STORAGE:  Refer to storage information printed on the package.||
1720|129|R|Protect from light. If you have any questions about storage, ask||
1720|130|R|your pharmacist. Keep all medications away from children and||
1720|131|R|pets.||
1720|132|R|   Do not flush medications down the toilet or pour them into a||
1720|133|R|drain unless instructed to do so. Properly discard this product||
1720|134|R|when it is expired or no longer needed. (See also How to Use||
1720|135|R|section.) Consult your pharmacist or local waste disposal||
1720|136|R|company.||
1720|137|B|||
1720|138|A|Information last revised February 2025.||
1720|139|A|Copyright(c) 2025 First Databank, Inc.||
1720|140|B|||
1722|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1722|002|Z|does NOT have all possible information about this product. This||
1722|003|Z|information does not assure that this product is safe, effective,||
1722|004|Z|or appropriate for you. This information is not individual||
1722|005|Z|medical advice and does not substitute for the advice of your||
1722|006|Z|health care professional. Always ask your health care||
1722|007|Z|professional for complete information about this product and your||
1722|008|Z|specific health needs.||
1722|009|B|||
1722|010|T|EMPAGLIFLOZIN/METFORMIN - ORAL||
1722|011|F|(EM-pa-gli-FLOE-zin/met-FOR-min)||
1722|012|B|||
1722|013|C|COMMON BRAND NAME(S): Synjardy||
1722|014|B|||
1722|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1722|016|W|cause a serious (sometimes fatal) condition called lactic||
1722|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1722|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1722|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1722|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1722|021|W|you are using certain drugs. For some conditions, your doctor may||
1722|022|W|tell you to stop taking this medication for a short time. Ask||
1722|023|W|your doctor or pharmacist for more details.||
1722|024|W|   Stop taking this medication and get medical help right away if||
1722|025|W|you have any symptoms of lactic acidosis, such as unusual||
1722|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1722|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1722|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1722|029|B|||
1722|030|U|USES:  This medication is a combination of 2 drugs: empagliflozin||
1722|031|U|and metformin. It is used with a proper diet and exercise program||
1722|032|U|to control high blood sugar in people with type 2 diabetes.||
1722|033|U|Controlling high blood sugar helps prevent kidney damage,||
1722|034|U|blindness, nerve problems, loss of limbs, and sexual function||
1722|035|U|problems. Proper control of diabetes may also lessen your risk of||
1722|036|U|a heart attack or stroke. This medication is also used to treat||
1722|037|U|heart failure or long-term kidney disease in people with type 2||
1722|038|U|diabetes. It may help lower the risk of death from heart disease||
1722|039|U|and reduce the need to go to a hospital to treat heart failure or||
1722|040|U|kidney disease. In people with long-term kidney disease, this||
1722|041|U|medication may also help slow down the worsening of kidney||
1722|042|U|disease.||
1722|043|U|   This medication works by helping to restore your body's proper||
1722|044|U|response to the insulin you naturally produce. It also increases||
1722|045|U|the removal of sugar by your kidneys, decreases how much sugar is||
1722|046|U|made in your liver, and decreases how much sugar your body takes||
1722|047|U|in through your stomach and intestines.||
1722|048|B|||
1722|049|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1722|050|H|Patient Information Leaflet provided by your pharmacist before||
1722|051|H|you start taking this medication and each time you get a refill.||
1722|052|H|If you have any questions, ask your doctor or pharmacist.||
1722|053|H|   Take this medication by mouth as directed by your doctor,||
1722|054|H|usually twice daily with meals. The dosage is based on your||
1722|055|H|medical condition, response to treatment, and other medications||
1722|056|H|you may be taking. Be sure to tell your doctor and pharmacist||
1722|057|H|about all the products you use (including prescription drugs,||
1722|058|H|nonprescription drugs, and herbal products). To reduce your risk||
1722|059|H|of side effects (such as diarrhea, nausea, and vomiting), your||
1722|060|H|doctor may direct you to start this medication at a low dose and||
1722|061|H|gradually increase your dose. Follow your doctor's instructions||
1722|062|H|carefully.||
1722|063|H|   Take this medication regularly to get the most benefit from||
1722|064|H|it. To help you remember, take it at the same times each day.||
1722|065|H|   Tell your doctor if your condition does not get better or if||
1722|066|H|it gets worse (your blood sugar is too high or too low).||
1722|067|B|||
1722|068|S|SIDE EFFECTS:  See also Warning section.||
1722|069|S|   Headache, diarrhea, nausea, vomiting, runny nose, or sore||
1722|070|S|throat may occur. If any of these effects last or get worse, tell||
1722|071|S|your doctor or pharmacist promptly. If stomach symptoms return||
1722|072|S|later (after taking the same dose for several days or weeks),||
1722|073|S|tell your doctor right away. Stomach symptoms that occur after||
1722|074|S|the first days of your treatment may be signs of lactic acidosis.||
1722|075|S|   Remember that this medication has been prescribed because your||
1722|076|S|doctor has judged that the benefit to you is greater than the||
1722|077|S|risk of side effects. Many people using this medication do not||
1722|078|S|have serious side effects.||
1722|079|S|   Tell your doctor right away if you have any serious side||
1722|080|S|effects, including: signs of a urinary tract infection (such as||
1722|081|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1722|082|S|signs of new or worsening kidney problems (such as change in the||
1722|083|S|amount of urine).||
1722|084|S|   This medication may cause a new yeast infection in the vagina||
1722|085|S|or the penis. It may also cause a rare but very serious bacterial||
1722|086|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1722|087|S|your doctor right away if you have signs of a yeast infection in||
1722|088|S|the vagina (such as unusual vaginal||
1722|089|S|discharge/burning/itching/odor) or in the penis (such as||
1722|090|S|redness/itching/swelling of the penis, unusual discharge from the||
1722|091|S|penis). However, get medical help right away if you have any||
1722|092|S|pain/redness/swelling in or around the genital/anal area, along||
1722|093|S|with a fever or feeling unwell.||
1722|094|S|   This medication may increase the risk of lower limb amputation||
1722|095|S|(especially of the toe and foot). The risk is higher if you have||
1722|096|S|poor blood flow in the legs, nerve problems, foot ulcers, or have||
1722|097|S|had a previous amputation. To lessen the risk, check your feet||
1722|098|S|regularly and tell your doctor if you have new pain, tenderness,||
1722|099|S|sores, or ulcers on your legs or feet.||
1722|100|S|   This medication does not usually cause low blood sugar||
1722|101|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1722|102|S|prescribed with other diabetes medications, or if you do not get||
1722|103|S|enough calories from food, or if you do unusually heavy exercise.||
1722|104|S|Talk with your doctor or pharmacist about whether the dose of||
1722|105|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1722|106|S|of low blood sugar include sudden sweating, shaking, fast||
1722|107|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1722|108|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1722|109|S|treat low blood sugar. If you don't have these reliable forms of||
1722|110|S|glucose, rapidly raise your blood sugar by eating a quick source||
1722|111|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1722|112|S|juice or non-diet soda. Tell your doctor right away about the||
1722|113|S|reaction and the use of this product. To help prevent low blood||
1722|114|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1722|115|S|Check with your doctor or pharmacist to find out what you should||
1722|116|S|do if you miss a meal.||
1722|117|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1722|118|S|thirst/urination. If these symptoms occur, tell your doctor right||
1722|119|S|away. Your doctor may need to adjust your diabetes medication,||
1722|120|S|exercise program, or diet.||
1722|121|S|   This medication may cause you to become dehydrated. This can||
1722|122|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1722|123|S|dehydration. Tell your doctor or pharmacist right away if you are||
1722|124|S|not able to drink fluids as usual, or losing fluid (such as due||
1722|125|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1722|126|S|right away if you have any signs of dehydration, such as||
1722|127|S|urinating less than usual, unusual dry mouth/thirst, fast||
1722|128|S|heartbeat, or dizziness/lightheadedness/fainting. To reduce the||
1722|129|S|risk of dizziness and lightheadedness, get up slowly when rising||
1722|130|S|from a sitting or lying position.||
1722|131|S|   A very serious allergic reaction to this drug is rare.||
1722|132|S|However, get medical help right away if you notice any symptoms||
1722|133|S|of a serious allergic reaction, including: rash, itching/swelling||
1722|134|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1722|135|S|breathing.||
1722|136|S|   This is not a complete list of possible side effects. If you||
1722|137|S|notice other effects not listed above, contact your doctor or||
1722|138|S|pharmacist.||
1722|139|S|   In the US -||
1722|140|S|   Call your doctor for medical advice about side effects. You||
1722|141|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1722|142|S|www.fda.gov/medwatch.||
1722|143|S|   In Canada - Call your doctor for medical advice about side||
1722|144|S|effects. You may report side effects to Health Canada at||
1722|145|S|1-866-234-2345.||
1722|146|B|||
1722|147|P|PRECAUTIONS:  See also Warning section.||
1722|148|P|   Before taking this medication, tell your doctor or pharmacist||
1722|149|P|if you are allergic to empagliflozin or metformin; or if you have||
1722|150|P|any other allergies. This product may contain inactive||
1722|151|P|ingredients, which can cause allergic reactions or other||
1722|152|P|problems. Talk to your pharmacist for more details.||
1722|153|P|   Before using this medication, tell your doctor or pharmacist||
1722|154|P|your medical history, especially of: breathing problems (such as||
1722|155|P|asthma, obstructive lung disease), kidney disease, liver disease,||
1722|156|P|disease of the pancreas (pancreatitis), use/abuse of alcohol,||
1722|157|P|yeast infections in the vagina or penis, dehydration, blocked or||
1722|158|P|narrowed blood vessels, usually in the leg, nerve problems (such||
1722|159|P|as diabetic peripheral neuropathy), foot sores or ulcers,||
1722|160|P|amputation, heart disease (such as heart failure, recent heart||
1722|161|P|attack), blood problems (such as anemia, vitamin B12 deficiency).||
1722|162|P|   You may experience blurred vision, dizziness, or drowsiness||
1722|163|P|due to extremely low or high blood sugar. Do not drive, use||
1722|164|P|machinery, or do anything that needs alertness or clear vision||
1722|165|P|until you can do it safely.||
1722|166|P|   Limit alcohol while taking this medication because it can||
1722|167|P|increase your risk of developing lactic acidosis, low blood||
1722|168|P|sugar, and a high ketone level.||
1722|169|P|   High fever, "water pills" (diuretics such as||
1722|170|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1722|171|P|may cause dehydration and increase your risk of lactic acidosis.||
1722|172|P|Stop taking this medication and tell your doctor right away if||
1722|173|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1722|174|P|fluids to prevent dehydration unless your doctor directs you||
1722|175|P|otherwise.||
1722|176|P|   It may be harder to control your blood sugar when your body is||
1722|177|P|stressed (such as due to fever, infection, injury, or surgery).||
1722|178|P|Also, if you are eating less or not able to eat due to these||
1722|179|P|conditions or any illness, this can lead to a high ketone level||
1722|180|P|while you are taking this medication. Consult your doctor because||
1722|181|P|this may require a change in your treatment plan, medications, or||
1722|182|P|blood sugar or ketone testing.||
1722|183|P|   Before having surgery or any X-ray/scanning procedure using||
1722|184|P|iodinated contrast, tell your doctor or dentist about all the||
1722|185|P|products you use (including prescription drugs, nonprescription||
1722|186|P|drugs, and herbal products). You may need to stop this medication||
1722|187|P|for a short time for the surgery/procedure. Ask your doctor or||
1722|188|P|dentist for instructions before your surgery/procedure.||
1722|189|P|   Children may be at greater risk for low blood sugar while||
1722|190|P|using this drug.||
1722|191|P|   Older adults may be more sensitive to the side effects of this||
1722|192|P|drug, especially low blood sugar, dehydration, lactic acidosis,||
1722|193|P|kidney problems, and low blood pressure.||
1722|194|P|   During pregnancy, this medication should be used only when||
1722|195|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1722|196|P|benefits with your doctor.||
1722|197|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1722|198|P|your doctor for managing your blood sugar while pregnant. Your||
1722|199|P|doctor may change your diabetes treatment during your pregnancy||
1722|200|P|(such as diet and medications including insulin).||
1722|201|P|   Metformin can cause changes in the menstrual cycle (promote||
1722|202|P|ovulation) and increase the risk of becoming pregnant. Consult||
1722|203|P|your doctor or pharmacist about the use of reliable birth control||
1722|204|P|while using this medication.||
1722|205|P|   Metformin passes into breast milk in small amounts. It is||
1722|206|P|unknown if empagliflozin passes into breast milk. Consult your||
1722|207|P|doctor before breastfeeding.||
1722|208|B|||
1722|209|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1722|210|I|medications work or increase your risk for serious side effects.||
1722|211|I|This document does not contain all possible drug interactions.||
1722|212|I|Keep a list of all the products you use (including||
1722|213|I|prescription/nonprescription drugs and herbal products) and share||
1722|214|I|it with your doctor and pharmacist. Do not start, stop, or change||
1722|215|I|the dosage of any medicines without your doctor's approval.||
1722|216|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1722|217|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1722|218|I|heartbeat you would usually feel when your blood sugar falls too||
1722|219|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1722|220|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1722|221|I|   Many drugs can affect your blood sugar, making it harder to||
1722|222|I|control. Before you start, stop, or change any medication, talk||
1722|223|I|with your doctor or pharmacist about how the medication may||
1722|224|I|affect your blood sugar. Check your blood sugar regularly as||
1722|225|I|directed and share the results with your doctor. Tell your doctor||
1722|226|I|right away if you have symptoms of high or low blood sugar. (See||
1722|227|I|also Side Effects section.) Your doctor may need to adjust your||
1722|228|I|diabetes medication, exercise program, or diet.||
1722|229|I|   This medication may interfere with certain lab tests (such as||
1722|230|I|urine glucose test), possibly causing false test results. Make||
1722|231|I|sure lab personnel and all your doctors know you use this drug.||
1722|232|B|||
1722|233|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1722|234|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1722|235|O|poison control center right away. US residents can call||
1722|236|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1722|237|O|Overdose can lead to lactic acidosis. Symptoms of overdose may||
1722|238|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
1722|239|O|rapid breathing, slow/irregular heartbeat.||
1722|240|B|||
1722|241|N|NOTES:  Do not share this medication with others.||
1722|242|N|   Attend a diabetes education program to learn more about how to||
1722|243|N|manage your diabetes with medications, diet, exercise, and||
1722|244|N|regular medical exams.||
1722|245|N|   Learn the symptoms of high and low blood sugar and how to||
1722|246|N|treat low blood sugar. Check your blood sugar regularly as||
1722|247|N|directed.||
1722|248|N|   Lab and/or medical tests (such as kidney function, liver||
1722|249|N|function, blood sugar, hemoglobin A1c, ketones, complete blood||
1722|250|N|counts, vitamin B12) should be done before you start taking this||
1722|251|N|medication and while you are taking it. Keep all medical and lab||
1722|252|N|appointments. Consult your doctor for more details.||
1722|253|B|||
1722|254|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1722|255|D|remember. If it is near the time of the next dose, skip the||
1722|256|D|missed dose. Take your next dose at the regular time. Do not||
1722|257|D|double the dose to catch up.||
1722|258|B|||
1722|259|R|STORAGE:  Store at room temperature away from light and moisture.||
1722|260|R|Do not store in the bathroom. Keep all medications away from||
1722|261|R|children and pets.||
1722|262|R|   Do not flush medications down the toilet or pour them into a||
1722|263|R|drain unless instructed to do so. Properly discard this product||
1722|264|R|when it is expired or no longer needed. Consult your pharmacist||
1722|265|R|or local waste disposal company.||
1722|266|B|||
1722|267|M|MEDICAL ALERT:  Your condition can cause complications in a||
1722|268|M|medical emergency. For information about enrolling in MedicAlert,||
1722|269|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1722|270|B|||
1722|271|A|Information last revised May 2025.||
1722|272|A|Copyright(c) 2025 First Databank, Inc.||
1722|273|B|||
1723|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1723|002|Z|does NOT have all possible information about this product. This||
1723|003|Z|information does not assure that this product is safe, effective,||
1723|004|Z|or appropriate for you. This information is not individual||
1723|005|Z|medical advice and does not substitute for the advice of your||
1723|006|Z|health care professional. Always ask your health care||
1723|007|Z|professional for complete information about this product and your||
1723|008|Z|specific health needs.||
1723|009|B|||
1723|010|T|EVOLOCUMAB - SUBCUTANEOUS INJECTION||
1723|011|F|(E-voe-LOK-ue-mab)||
1723|012|B|||
1723|013|C|COMMON BRAND NAME(S): Repatha||
1723|014|B|||
1723|015|U|USES:  Evolocumab is used along with a proper diet to help lower||
1723|016|U|"bad" cholesterol (LDL) in the blood. It is also used by people||
1723|017|U|who have a high risk for serious heart and blood vessel problems||
1723|018|U|to reduce the risk of heart attack, stroke, certain types of||
1723|019|U|chest pain, death from heart disease, and needing certain types||
1723|020|U|of heart surgery. This medication belongs to a class of drugs||
1723|021|U|known as monoclonal antibodies. It works by improving how well||
1723|022|U|your body gets rid of LDL cholesterol.||
1723|023|U|   In addition to eating a proper diet (such as a||
1723|024|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
1723|025|U|help this medication work better include exercising, losing||
1723|026|U|weight if overweight, and stopping smoking. Consult your doctor||
1723|027|U|for more details.||
1723|028|B|||
1723|029|H|HOW TO USE:  Read the Patient Information Leaflet and||
1723|030|H|Instructions for Use if available from your pharmacist before you||
1723|031|H|start using evolocumab and each time you get a refill. Ask your||
1723|032|H|health care professional how to prepare and use this medication.||
1723|033|H|If you have any questions, ask your doctor or pharmacist.||
1723|034|H|   Inject this medication under the skin as directed by your||
1723|035|H|doctor, usually once every 2 weeks or once every month. The||
1723|036|H|injection is given in the thigh, abdomen, or upper arm. The||
1723|037|H|dosage is based on your medical condition and response to||
1723|038|H|treatment. If your doctor has prescribed the monthly dose and you||
1723|039|H|are using the prefilled syringe/pen, you will use 3 separate||
1723|040|H|injections within 30 minutes. If you are using the on-body||
1723|041|H|infusor, the medication is injected over 5 minutes.||
1723|042|H|   Depending on your product, take the medication out of the||
1723|043|H|refrigerator at least 30 to 45 minutes before you inject it to||
1723|044|H|allow it to reach room temperature. Do not warm up this||
1723|045|H|medication any other way (for example, do not heat it in the||
1723|046|H|microwave or place it in hot water). Do not shake the medication.||
1723|047|H|Before using, check this product for particles or discoloration.||
1723|048|H|If either is present, do not use the liquid. Before injecting||
1723|049|H|each dose, clean the skin you are going to inject into (the||
1723|050|H|injection site) with rubbing alcohol. Change the injection site||
1723|051|H|each time to lessen injury under the skin. Do not inject into||
1723|052|H|skin that is injured, tender, hard, red, or has scars or stretch||
1723|053|H|marks. To lessen bruising, do not rub the injection site after a||
1723|054|H|shot. Learn how to store and discard medical supplies safely.||
1723|055|H|   Use this medication regularly to get the most benefit from it.||
1723|056|H|To help you remember, mark your calendar with a reminder.||
1723|057|B|||
1723|058|S|SIDE EFFECTS:  Redness, pain, or bruising at the injection site||
1723|059|S|may occur. If any of these effects last or get worse, tell your||
1723|060|S|doctor or pharmacist promptly.||
1723|061|S|   Remember that this medication has been prescribed because your||
1723|062|S|doctor has judged that the benefit to you is greater than the||
1723|063|S|risk of side effects. Many people using this medication do not||
1723|064|S|have serious side effects.||
1723|065|S|   A very serious allergic reaction to this drug is rare.||
1723|066|S|However, get medical help right away if you notice any symptoms||
1723|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1723|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1723|069|S|breathing.||
1723|070|S|   This is not a complete list of possible side effects. If you||
1723|071|S|notice other effects not listed above, contact your doctor or||
1723|072|S|pharmacist.||
1723|073|S|   In the US -||
1723|074|S|   Call your doctor for medical advice about side effects. You||
1723|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1723|076|S|www.fda.gov/medwatch.||
1723|077|S|   In Canada - Call your doctor for medical advice about side||
1723|078|S|effects. You may report side effects to Health Canada at||
1723|079|S|1-866-234-2345.||
1723|080|B|||
1723|081|P|PRECAUTIONS:  Before using evolocumab, tell your doctor or||
1723|082|P|pharmacist if you are allergic to it; or if you have any other||
1723|083|P|allergies. This product may contain inactive ingredients (such as||
1723|084|P|latex or dry natural rubber found in the needle cover of some||
1723|085|P|brands) which can cause allergic reactions or other problems.||
1723|086|P|Talk to your pharmacist for more details.||
1723|087|P|   Before using this medication, tell your doctor or pharmacist||
1723|088|P|your medical history.||
1723|089|P|   Before having surgery, tell your doctor or dentist about all||
1723|090|P|the products you use (including prescription drugs,||
1723|091|P|nonprescription drugs, and herbal products).||
1723|092|P|   During pregnancy, this medication should be used only when||
1723|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
1723|094|P|   It is unknown if this medication passes into breast milk.||
1723|095|P|Consult your doctor before breastfeeding.||
1723|096|B|||
1723|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1723|098|I|medications work or increase your risk for serious side effects.||
1723|099|I|This document does not contain all possible drug interactions.||
1723|100|I|Keep a list of all the products you use (including||
1723|101|I|prescription/nonprescription drugs and herbal products) and share||
1723|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
1723|103|I|the dosage of any medicines without your doctor's approval.||
1723|104|B|||
1723|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1723|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1723|107|O|poison control center right away. US residents can call||
1723|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1723|109|B|||
1723|110|N|NOTES:  Do not share this medication with others.||
1723|111|N|   Lab and/or medical tests (such as LDL cholesterol levels)||
1723|112|N|should be done while you are using this medication. Keep all||
1723|113|N|medical and lab appointments.||
1723|114|B|||
1723|115|D|MISSED DOSE:  If you are using this medication every 2 weeks and||
1723|116|D|miss a dose, use it as soon as you remember. If it is more than 7||
1723|117|D|days after the missed dose, skip the missed dose. Use your next||
1723|118|D|dose at the regular time. Do not double the dose to catch up.||
1723|119|D|   If you are using this medication once a month and miss a dose,||
1723|120|D|use it as soon as you remember if it is within 7 days from the||
1723|121|D|missed dose, then use your next dose at the regular time. If it||
1723|122|D|is more than 7 days after the missed dose, use it as soon as you||
1723|123|D|remember and start a new monthly schedule based on this date. Do||
1723|124|D|not double the dose to catch up.||
1723|125|B|||
1723|126|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1723|127|R|medication in original carton to protect from light. This||
1723|128|R|medication may also be stored at room temperature if needed. If||
1723|129|R|the medication is stored at room temperature, discard after 30||
1723|130|R|days. Keep all medications away from children and pets.||
1723|131|R|   Do not flush medications down the toilet or pour them into a||
1723|132|R|drain unless instructed to do so. Properly discard this product||
1723|133|R|when it is expired or no longer needed. Consult your pharmacist||
1723|134|R|or local waste disposal company.||
1723|135|B|||
1723|136|A|Information last revised September 2025.||
1723|137|A|Copyright(c) 2025 First Databank, Inc.||
1723|138|B|||
1724|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1724|002|Z|does NOT have all possible information about this product. This||
1724|003|Z|information does not assure that this product is safe, effective,||
1724|004|Z|or appropriate for you. This information is not individual||
1724|005|Z|medical advice and does not substitute for the advice of your||
1724|006|Z|health care professional. Always ask your health care||
1724|007|Z|professional for complete information about this product and your||
1724|008|Z|specific health needs.||
1724|009|B|||
1724|010|T|ACLIDINIUM/FORMOTEROL POWDER INHALER - ORAL INHALATION||
1724|011|F|(A-kli-DIN-ee-um/for-MOE-ter-ol)||
1724|012|B|||
1724|013|C|COMMON BRAND NAME(S): Duaklir Pressair||
1724|014|B|||
1724|015|U|USES:  This product is used to control and prevent symptoms (such||
1724|016|U|as wheezing and shortness of breath) caused by ongoing lung||
1724|017|U|disease (chronic obstructive pulmonary disease-COPD, which||
1724|018|U|includes chronic bronchitis and emphysema). Controlling symptoms||
1724|019|U|of breathing problems helps you stay active. This inhaler||
1724|020|U|contains 2 medications: aclidinium and formoterol. Both drugs||
1724|021|U|work by relaxing the muscles around the airways so that they open||
1724|022|U|up and you can breathe more easily. Aclidinium belongs to a class||
1724|023|U|of drugs known as anticholinergics, and formoterol belongs to a||
1724|024|U|class of drugs known as long-acting beta agonists (LABAs). Both||
1724|025|U|drugs are also known as bronchodilators.||
1724|026|U|   This medication must be used regularly to be effective. It||
1724|027|U|does not work right away and should not be used to relieve sudden||
1724|028|U|shortness of breath. If sudden breathing problems occur, use your||
1724|029|U|quick-relief inhaler as prescribed.||
1724|030|U|   This medication is not approved to treat asthma.||
1724|031|B|||
1724|032|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1724|033|H|your pharmacist before you start using this medication and each||
1724|034|H|time you get a refill. Follow the illustrated directions for the||
1724|035|H|proper use of this medication. If you have any questions, ask||
1724|036|H|your doctor or pharmacist.||
1724|037|H|   Inhale this medication by mouth as directed by your doctor,||
1724|038|H|usually twice daily (once in the morning and once in the||
1724|039|H|evening). You may or may not taste the drug when you inhale. Do||
1724|040|H|not exhale into the device. Avoid getting any of this medication||
1724|041|H|in your eyes.||
1724|042|H|   Use this medication regularly to get the most benefit from it.||
1724|043|H|To help you remember, use it at the same times each day.||
1724|044|H|   Do not increase your dose, use this medication more often, or||
1724|045|H|stop using it without first consulting your doctor. Your||
1724|046|H|condition will not improve any faster, and your risk of side||
1724|047|H|effects will increase.||
1724|048|H|   If you are using other inhalers at the same time, wait at||
1724|049|H|least 1 minute between the use of each medication.||
1724|050|H|   If you have been using a quick-relief inhaler (such as||
1724|051|H|albuterol, also called salbutamol in some countries) on a regular||
1724|052|H|daily schedule (such as 4 times daily), you must stop this||
1724|053|H|schedule and only use the quick-relief inhaler as needed for||
1724|054|H|sudden shortness of breath. Consult your doctor for details.||
1724|055|H|   Learn which of your inhalers you should use every day and||
1724|056|H|which you should use if your breathing suddenly worsens||
1724|057|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1724|058|H|should do if you have new or worsening cough or shortness of||
1724|059|H|breath, wheezing, increased sputum, waking up at night with||
1724|060|H|trouble breathing, if you use your quick-relief inhaler more||
1724|061|H|often, or if your quick-relief inhaler does not seem to be||
1724|062|H|working well. Learn when you can treat sudden breathing problems||
1724|063|H|by yourself and when you must get medical help right away.||
1724|064|H|   Tell your doctor if your condition does not get better or if||
1724|065|H|it gets worse.||
1724|066|B|||
1724|067|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1724|068|S|because your doctor has judged that the benefit to you is greater||
1724|069|S|than the risk of side effects. Many people using this medication||
1724|070|S|do not have serious side effects.||
1724|071|S|   Tell your doctor right away if you have any serious side||
1724|072|S|effects, including: difficult/painful urination, muscle||
1724|073|S|cramps/weakness, increased thirst/urination.||
1724|074|S|   This medication may raise your blood pressure. Check your||
1724|075|S|blood pressure regularly and tell your doctor if the results are||
1724|076|S|high.||
1724|077|S|   Rarely, this medication may cause sudden severe||
1724|078|S|wheezing/trouble breathing right after you use it. If this||
1724|079|S|occurs, use your quick-relief inhaler and get medical help right||
1724|080|S|away.||
1724|081|S|   Rarely, people with asthma who use LABA medications without an||
1724|082|S|inhaled corticosteroid medication have had serious (sometimes||
1724|083|S|fatal) asthma-related breathing problems. Aclidinium/formoterol||
1724|084|S|is not approved to treat asthma.||
1724|085|S|   Get medical help right away if you have any very serious side||
1724|086|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1724|087|S|dizziness, fainting, eye pain/swelling/redness, vision changes||
1724|088|S|(such as seeing rainbows around lights at night, blurred vision).||
1724|089|S|   A very serious allergic reaction to this drug is rare.||
1724|090|S|However, get medical help right away if you notice any symptoms||
1724|091|S|of a serious allergic reaction, including: rash, itching/swelling||
1724|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1724|093|S|breathing.||
1724|094|S|   This is not a complete list of possible side effects. If you||
1724|095|S|notice other effects not listed above, contact your doctor or||
1724|096|S|pharmacist.||
1724|097|S|   In the US -||
1724|098|S|   Call your doctor for medical advice about side effects. You||
1724|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1724|100|S|www.fda.gov/medwatch.||
1724|101|S|   In Canada - Call your doctor for medical advice about side||
1724|102|S|effects. You may report side effects to Health Canada at||
1724|103|S|1-866-234-2345.||
1724|104|B|||
1724|105|P|PRECAUTIONS:  Before using aclidinium/formoterol, tell your||
1724|106|P|doctor or pharmacist if you are allergic to either drug, or if||
1724|107|P|you have any other allergies. This product may contain inactive||
1724|108|P|ingredients (such as milk proteins), which can cause allergic||
1724|109|P|reactions or other problems. Talk to your pharmacist for more||
1724|110|P|details.||
1724|111|P|   Before using this medication, tell your doctor or pharmacist||
1724|112|P|your medical history, especially of: heart problems (such as||
1724|113|P|chest pain, irregular heartbeat), high blood pressure, seizures,||
1724|114|P|overactive thyroid, diabetes, personal or family history of||
1724|115|P|glaucoma (angle-closure type), difficulty urinating (such as due||
1724|116|P|to an enlarged prostate), a certain adrenal gland tumor||
1724|117|P|(pheochromocytoma).||
1724|118|P|   Aclidinium/formoterol may cause a condition that affects the||
1724|119|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
1724|120|P|serious (rarely fatal) fast/irregular heartbeat and other||
1724|121|P|symptoms (such as severe dizziness, fainting) that need medical||
1724|122|P|attention right away.||
1724|123|P|   The risk of QT prolongation may be increased if you have||
1724|124|P|certain medical conditions or are taking other drugs that may||
1724|125|P|cause QT prolongation. Before using aclidinium/formoterol, tell||
1724|126|P|your doctor or pharmacist of all the drugs you take and if you||
1724|127|P|have any of the following conditions: certain heart problems||
1724|128|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
1724|129|P|family history of certain heart problems (QT prolongation in the||
1724|130|P|EKG, sudden cardiac death).||
1724|131|P|   Low levels of potassium or magnesium in the blood may also||
1724|132|P|increase your risk of QT prolongation. This risk may increase if||
1724|133|P|you use certain drugs (such as diuretics/"water pills") or if you||
1724|134|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1724|135|P|Talk to your doctor about using aclidinium/formoterol safely.||
1724|136|P|   Before having surgery, tell your doctor or dentist about all||
1724|137|P|the products you use (including prescription drugs,||
1724|138|P|nonprescription drugs, and herbal products).||
1724|139|P|   Older adults may be more sensitive to the side effects of this||
1724|140|P|drug, especially QT prolongation (see above).||
1724|141|P|   During pregnancy, this medication should be used only when||
1724|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
1724|143|P|   It is unknown if this medication passes into breast milk.||
1724|144|P|Consult your doctor before breastfeeding.||
1724|145|B|||
1724|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1724|147|I|medications work or increase your risk for serious side effects.||
1724|148|I|This document does not contain all possible drug interactions.||
1724|149|I|Keep a list of all the products you use (including||
1724|150|I|prescription/nonprescription drugs and herbal products) and share||
1724|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
1724|152|I|the dosage of any medicines without your doctor's approval.||
1724|153|I|   Do not use other LABA drugs (such as salmeterol, vilanterol)||
1724|154|I|while using this medication.||
1724|155|B|||
1724|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1724|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1724|158|O|poison control center right away. US residents can call||
1724|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1724|160|O|Symptoms of overdose may include: shaking (tremor), chest pain,||
1724|161|O|fast/irregular heartbeat, severe dizziness.||
1724|162|B|||
1724|163|N|NOTES:  Do not share this medication with others.||
1724|164|N|   Lab and/or medical tests (such as lung function, blood||
1724|165|N|pressure, pulse/heart rate) should be done while you are using||
1724|166|N|this medication. Keep all medical and lab appointments.||
1724|167|N|   Avoid substances that can worsen breathing problems by causing||
1724|168|N|irritation or allergic reaction, such as smoke, pollen, pet||
1724|169|N|dander, dust, and mold.||
1724|170|N|   Because the flu virus can worsen breathing problems, ask your||
1724|171|N|doctor or pharmacist if you should have a flu shot every year.||
1724|172|B|||
1724|173|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1724|174|D|If it is near the time of the next dose, skip the missed dose.||
1724|175|D|Use your next dose at the regular time. Do not double the dose to||
1724|176|D|catch up.||
1724|177|B|||
1724|178|R|STORAGE:  Store at room temperature away from light and moisture.||
1724|179|R|Do not store in the bathroom. Do not open the sealed pouch until||
1724|180|R|you are ready to use the new inhaler. Once the sealed pouch is||
1724|181|R|opened, this medication expires after 60 days. Keep all||
1724|182|R|medications away from children and pets.||
1724|183|R|   Do not flush medications down the toilet or pour them into a||
1724|184|R|drain unless instructed to do so. Properly discard this product||
1724|185|R|when it is expired or no longer needed. Consult your pharmacist||
1724|186|R|or local waste disposal company.||
1724|187|B|||
1724|188|M|MEDICAL ALERT:  Your condition can cause complications in a||
1724|189|M|medical emergency. For information about enrolling in MedicAlert,||
1724|190|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1724|191|B|||
1724|192|A|Information last revised July 2025.||
1724|193|A|Copyright(c) 2025 First Databank, Inc.||
1724|194|B|||
1725|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1725|002|Z|does NOT have all possible information about this product. This||
1725|003|Z|information does not assure that this product is safe, effective,||
1725|004|Z|or appropriate for you. This information is not individual||
1725|005|Z|medical advice and does not substitute for the advice of your||
1725|006|Z|health care professional. Always ask your health care||
1725|007|Z|professional for complete information about this product and your||
1725|008|Z|specific health needs.||
1725|009|B|||
1725|010|T|FLIBANSERIN - ORAL||
1725|011|F|(flib-AN-ser-in)||
1725|012|B|||
1725|013|C|COMMON BRAND NAME(S): Addyi||
1725|014|B|||
1725|015|W|WARNING:  Drinking alcohol close to the time that you take||
1725|016|W|flibanserin can increase the risk of severe low blood pressure||
1725|017|W|and fainting. If you drink one or two alcoholic drinks in the||
1725|018|W|evening, you must wait at least 2 hours before taking flibanserin||
1725|019|W|at bedtime. After taking flibanserin at bedtime, do not drink any||
1725|020|W|alcohol until the next day. If you drink 3 or more alcoholic||
1725|021|W|drinks in the evening, then you should skip your dose of||
1725|022|W|flibanserin that night. Examples of an alcoholic drink could be a||
1725|023|W|12-ounce can of beer, a 5-ounce glass of wine, or a 1.5 ounce||
1725|024|W|shot of distilled spirits. Consult your doctor and pharmacist for||
1725|025|W|more details and to discuss the risks and benefits of using||
1725|026|W|flibanserin.||
1725|027|W|   Do not take flibanserin if you have liver problems or if you||
1725|028|W|take certain medications that may interact with flibanserin||
1725|029|W|because your risk for severe low blood pressure or fainting will||
1725|030|W|increase. See the Drug Interactions section. Before using||
1725|031|W|flibanserin, tell your doctor and pharmacist if you have liver||
1725|032|W|problems and about all the products you use (including||
1725|033|W|prescription drugs, nonprescription drugs, and herbal products).||
1725|034|W|Also, before you start using any new product, ask your doctor and||
1725|035|W|pharmacist if it could interact with flibanserin.||
1725|036|B|||
1725|037|U|USES:  This medication is used to treat women who have not gone||
1725|038|U|through menopause who have low sexual desire and are concerned||
1725|039|U|about it.||
1725|040|U|   Flibanserin should not be used to treat low sexual desire||
1725|041|U|caused by: a medical or mental/mood disorder, problems in the||
1725|042|U|relationship, or the effects of other drugs. This medication||
1725|043|U|should not be used by women who have gone through menopause, or||
1725|044|U|by men. Flibanserin is not used to enhance sexual performance.||
1725|045|B|||
1725|046|H|HOW TO USE:  Read the Medication Guide provided by your||
1725|047|H|pharmacist before you start taking flibanserin and each time you||
1725|048|H|get a refill. If you have any questions, ask your doctor or||
1725|049|H|pharmacist.||
1725|050|H|   Take this medication by mouth as directed by your doctor,||
1725|051|H|usually once daily at bedtime. Take flibanserin only at bedtime||
1725|052|H|to reduce your risk of low blood pressure, fainting, and||
1725|053|H|drowsiness while you are awake. After taking flibanserin, do not||
1725|054|H|drink any alcohol until the next day. See also Warning section.||
1725|055|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1725|056|H|using this medication unless your doctor or pharmacist says you||
1725|057|H|may do so safely. Grapefruit can increase the chance of side||
1725|058|H|effects with this medicine. Ask your doctor or pharmacist for||
1725|059|H|more details.||
1725|060|H|   Take this medication regularly to get the most benefit from||
1725|061|H|it. To help you remember, take it at the same time each day.||
1725|062|H|   Tell your doctor if your condition does not get better after 8||
1725|063|H|weeks of treatment.||
1725|064|B|||
1725|065|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1725|066|S|   Drowsiness, dizziness, nausea, or tiredness may occur. If any||
1725|067|S|of these effects last or get worse, tell your doctor or||
1725|068|S|pharmacist promptly.||
1725|069|S|   Remember that this medication has been prescribed because your||
1725|070|S|doctor has judged that the benefit to you is greater than the||
1725|071|S|risk of side effects. Many people using this medication do not||
1725|072|S|have serious side effects.||
1725|073|S|   Low blood pressure and fainting may occur even if you take||
1725|074|S|flibanserin by itself. The risk of these side effects is greater||
1725|075|S|if you take this medication with or less than 2 hours after||
1725|076|S|alcohol, or at a time of day other than at bedtime, or if you||
1725|077|S|take more of it than prescribed. If you feel dizzy or||
1725|078|S|lightheaded, lie down right away. Get medical help right away or||
1725|079|S|have someone get medical help for you right away if symptoms last||
1725|080|S|or if you faint.||
1725|081|S|   A very serious allergic reaction to this drug is rare.||
1725|082|S|However, get medical help right away if you notice any symptoms||
1725|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1725|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1725|085|S|breathing.||
1725|086|S|   This is not a complete list of possible side effects. If you||
1725|087|S|notice other effects not listed above, contact your doctor or||
1725|088|S|pharmacist.||
1725|089|S|   In the US -||
1725|090|S|   Call your doctor for medical advice about side effects. You||
1725|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1725|092|S|www.fda.gov/medwatch.||
1725|093|S|   In Canada - Call your doctor for medical advice about side||
1725|094|S|effects. You may report side effects to Health Canada at||
1725|095|S|1-866-234-2345.||
1725|096|B|||
1725|097|P|PRECAUTIONS:  Before taking flibanserin, tell your doctor or||
1725|098|P|pharmacist if you are allergic to it; or if you have any other||
1725|099|P|allergies. This product may contain inactive ingredients, which||
1725|100|P|can cause allergic reactions or other problems. Talk to your||
1725|101|P|pharmacist for more details.||
1725|102|P|   Before using this medication, tell your doctor or pharmacist||
1725|103|P|your medical history, especially of: alcohol use, regular||
1725|104|P|use/abuse of drugs/alcohol, liver problems, low blood pressure.||
1725|105|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1725|106|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1725|107|P|machinery, or do anything that needs alertness until at least 6||
1725|108|P|hours after taking flibanserin and until you can do it safely.||
1725|109|P|Avoid alcoholic beverages. Talk to your doctor if you are using||
1725|110|P|marijuana (cannabis).||
1725|111|P|   Before having surgery, tell your doctor or dentist about all||
1725|112|P|the products you use (including prescription drugs,||
1725|113|P|nonprescription drugs, and herbal products).||
1725|114|P|   During pregnancy, this medication should be used only when||
1725|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
1725|116|P|   It is unknown if this medication passes into breast milk.||
1725|117|P|Because of the possible risk to the infant, breastfeeding is not||
1725|118|P|recommended while using this medication. Consult your doctor||
1725|119|P|before breastfeeding.||
1725|120|B|||
1725|121|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
1725|122|I|   Drug interactions may change how your medications work or||
1725|123|I|increase your risk for serious side effects. This document does||
1725|124|I|not contain all possible drug interactions. Keep a list of all||
1725|125|I|the products you use (including prescription/nonprescription||
1725|126|I|drugs and herbal products) and share it with your doctor and||
1725|127|I|pharmacist. Do not start, stop, or change the dosage of any||
1725|128|I|medicines without your doctor's approval.||
1725|129|I|   Other medications can affect the removal of flibanserin from||
1725|130|I|your body, which may affect how flibanserin works. Examples||
1725|131|I|include azole antifungals (such as fluconazole, ketoconazole),||
1725|132|I|certain calcium channel blockers (such as diltiazem, verapamil),||
1725|133|I|macrolide antibiotics (such as clarithromycin, erythromycin),||
1725|134|I|nefazodone, rifamycins (such as rifabutin, rifampin), ritonavir,||
1725|135|I|St. John's wort, drugs used to treat seizures (such as||
1725|136|I|carbamazepine, phenytoin), among others.||
1725|137|I|   Tell your doctor or pharmacist if you are taking other||
1725|138|I|products that cause drowsiness such as opioid pain or cough||
1725|139|I|relievers (such as codeine, hydrocodone), marijuana (cannabis),||
1725|140|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
1725|141|I|zolpidem), muscle relaxants (such as carisoprodol,||
1725|142|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1725|143|I|diphenhydramine).||
1725|144|I|   Check the labels on all your medicines (such as allergy or||
1725|145|I|cough-and-cold products) because they may contain ingredients||
1725|146|I|that cause drowsiness. Ask your pharmacist about using those||
1725|147|I|products safely.||
1725|148|B|||
1725|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1725|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1725|151|O|poison control center right away. US residents can call||
1725|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1725|153|O|Symptoms of overdose may include: severe drowsiness, severe||
1725|154|O|dizziness, fainting.||
1725|155|B|||
1725|156|N|NOTES:  Do not share this medication with others.||
1725|157|B|||
1725|158|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1725|159|D|next dose at bedtime the next day. Do not double the dose to||
1725|160|D|catch up.||
1725|161|B|||
1725|162|R|STORAGE:  Store at room temperature away from light and moisture.||
1725|163|R|Do not store in the bathroom. Keep all medications away from||
1725|164|R|children and pets.||
1725|165|R|   Do not flush medications down the toilet or pour them into a||
1725|166|R|drain unless instructed to do so. Properly discard this product||
1725|167|R|when it is expired or no longer needed. Consult your pharmacist||
1725|168|R|or local waste disposal company.||
1725|169|B|||
1725|170|A|Information last revised May 2024.||
1725|171|A|Copyright(c) 2025 First Databank, Inc.||
1725|172|B|||
1726|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1726|002|Z|does NOT have all possible information about this product. This||
1726|003|Z|information does not assure that this product is safe, effective,||
1726|004|Z|or appropriate for you. This information is not individual||
1726|005|Z|medical advice and does not substitute for the advice of your||
1726|006|Z|health care professional. Always ask your health care||
1726|007|Z|professional for complete information about this product and your||
1726|008|Z|specific health needs.||
1726|009|B|||
1726|010|T|SONIDEGIB - ORAL||
1726|011|F|(SOE-ni-DEG-ib)||
1726|012|B|||
1726|013|C|COMMON BRAND NAME(S): Odomzo||
1726|014|B|||
1726|015|W|WARNING:  Sonidegib is not recommended for use during pregnancy||
1726|016|W|because it may cause serious harm (possibly death) to an unborn||
1726|017|W|baby. Women of childbearing age must have a pregnancy test before||
1726|018|W|starting this medication. They must also use reliable forms of||
1726|019|W|birth control while taking sonidegib and for 20 months after the||
1726|020|W|last dose of this medication.||
1726|021|W|   It is unknown if sonidegib passes into semen. Because of the||
1726|022|W|possible risk of passing the drug on to a partner, men taking||
1726|023|W|sonidegib (including men who have had a vasectomy) must use||
1726|024|W|condoms during sex with women who are pregnant or of childbearing||
1726|025|W|age, both during treatment with sonidegib and for 8 months after||
1726|026|W|the last dose of this medication. Men should also not donate||
1726|027|W|sperm during this time.||
1726|028|W|   If you or your partner become pregnant or think you may be||
1726|029|W|pregnant, tell your doctor right away.||
1726|030|B|||
1726|031|U|USES:  This medication is used to treat a certain type of skin||
1726|032|U|cancer (basal cell carcinoma).||
1726|033|B|||
1726|034|H|HOW TO USE:  Read the Medication Guide provided by your||
1726|035|H|pharmacist before you start taking sonidegib and each time you||
1726|036|H|get a refill. If you have any questions, ask your doctor or||
1726|037|H|pharmacist.||
1726|038|H|   Take this medication by mouth as directed by your doctor,||
1726|039|H|usually once daily on an empty stomach, at least 1 hour before or||
1726|040|H|2 hours after a meal.||
1726|041|H|   Use this medication regularly to get the most benefit from it.||
1726|042|H|To help you remember, take it at the same time each day.||
1726|043|H|   Do not increase your dose or use this drug more often or for||
1726|044|H|longer than prescribed. Your condition will not improve any||
1726|045|H|faster, and your risk of side effects will increase.||
1726|046|H|   Tell your doctor if your condition does not get better or if||
1726|047|H|it gets worse.||
1726|048|B|||
1726|049|S|SIDE EFFECTS:  Tiredness, abnormal taste, hair loss, headache,||
1726|050|S|weight loss, nausea/vomiting, diarrhea, stomach/abdominal pain,||
1726|051|S|mild itching, or decreased appetite may occur. If any of these||
1726|052|S|effects last or get worse, tell your doctor or pharmacist||
1726|053|S|promptly.||
1726|054|S|   Remember that this medication has been prescribed because your||
1726|055|S|doctor has judged that the benefit to you is greater than the||
1726|056|S|risk of side effects. Many people using this medication do not||
1726|057|S|have serious side effects.||
1726|058|S|   Tell your doctor right away if you have any serious side||
1726|059|S|effects, including: muscle pain/tenderness/weakness/spasms, signs||
1726|060|S|of kidney problems (such as change in the amount of urine),||
1726|061|S|missed periods.||
1726|062|S|   A very serious allergic reaction to this drug is rare.||
1726|063|S|However, get medical help right away if you notice any symptoms||
1726|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1726|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1726|066|S|breathing.||
1726|067|S|   This is not a complete list of possible side effects. If you||
1726|068|S|notice other effects not listed above, contact your doctor or||
1726|069|S|pharmacist.||
1726|070|S|   In the US -||
1726|071|S|   Call your doctor for medical advice about side effects. You||
1726|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1726|073|S|www.fda.gov/medwatch.||
1726|074|S|   In Canada - Call your doctor for medical advice about side||
1726|075|S|effects. You may report side effects to Health Canada at||
1726|076|S|1-866-234-2345.||
1726|077|B|||
1726|078|P|PRECAUTIONS:  Before taking sonidegib, tell your doctor or||
1726|079|P|pharmacist if you are allergic to it; or if you have any other||
1726|080|P|allergies. This product may contain inactive ingredients, which||
1726|081|P|can cause allergic reactions or other problems. Talk to your||
1726|082|P|pharmacist for more details.||
1726|083|P|   Before using this medication, tell your doctor or pharmacist||
1726|084|P|your medical history.||
1726|085|P|   Before having surgery, tell your doctor or dentist about all||
1726|086|P|the products you use (including prescription drugs,||
1726|087|P|nonprescription drugs, and herbal products).||
1726|088|P|   Do not donate blood while taking this drug and for 20 months||
1726|089|P|after stopping treatment. This will prevent your blood being||
1726|090|P|given to a pregnant woman.||
1726|091|P|   Older adults may be more sensitive to the side effects of this||
1726|092|P|drug.||
1726|093|P|   This medication may stop normal bone growth and affect final||
1726|094|P|height if it is used by children/young adults. Ask your doctor||
1726|095|P|for more details.||
1726|096|P|   This medication is not recommended for use during pregnancy.||
1726|097|P|It may harm an unborn baby. Discuss the use of reliable forms of||
1726|098|P|birth control (such as condoms, birth control pills) with your||
1726|099|P|doctor. Consult your doctor for more details. (See also Warning||
1726|100|P|section.)||
1726|101|P|   It is unknown if this medication passes into breast milk.||
1726|102|P|Because of the possible risk to the infant, breastfeeding is not||
1726|103|P|recommended while using this medication and for 20 months after||
1726|104|P|the last dose. Consult your doctor before breastfeeding.||
1726|105|B|||
1726|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1726|107|I|medications work or increase your risk for serious side effects.||
1726|108|I|This document does not contain all possible drug interactions.||
1726|109|I|Keep a list of all the products you use (including||
1726|110|I|prescription/nonprescription drugs and herbal products) and share||
1726|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
1726|112|I|the dosage of any medicines without your doctor's approval.||
1726|113|I|   Other medications can affect the removal of sonidegib from||
1726|114|I|your body, which may affect how sonidegib works. Examples include||
1726|115|I|azole antifungals (such as itraconazole, ketoconazole),||
1726|116|I|efavirenz, modafinil, nefazodone, rifamycins (such as rifabutin),||
1726|117|I|ritonavir, St. John's wort, drugs used to treat seizures (such as||
1726|118|I|carbamazepine, phenytoin), telithromycin, among others.||
1726|119|B|||
1726|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1726|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1726|122|O|poison control center right away. US residents can call||
1726|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1726|124|B|||
1726|125|N|NOTES:  Do not share this medication with others.||
1726|126|N|   Lab and/or medical tests (such as a pregnancy test,||
1726|127|N|kidney/liver function, creatine kinase levels, complete blood||
1726|128|N|count, blood glucose) should be done before you start taking this||
1726|129|N|medication and while you are taking it. Keep all medical and lab||
1726|130|N|appointments. Consult your doctor for more details.||
1726|131|B|||
1726|132|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1726|133|D|next dose at the regular time. Do not double the dose to catch||
1726|134|D|up.||
1726|135|B|||
1726|136|R|STORAGE:  Store at room temperature away from light and moisture.||
1726|137|R|Do not store in the bathroom. Keep all medications away from||
1726|138|R|children and pets.||
1726|139|R|   Do not flush medications down the toilet or pour them into a||
1726|140|R|drain unless instructed to do so. Properly discard this product||
1726|141|R|when it is expired or no longer needed. Consult your pharmacist||
1726|142|R|or local waste disposal company.||
1726|143|B|||
1726|144|A|Information last revised April 2025.||
1726|145|A|Copyright(c) 2025 First Databank, Inc.||
1726|146|B|||
1727|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1727|002|Z|does NOT have all possible information about this product. This||
1727|003|Z|information does not assure that this product is safe, effective,||
1727|004|Z|or appropriate for you. This information is not individual||
1727|005|Z|medical advice and does not substitute for the advice of your||
1727|006|Z|health care professional. Always ask your health care||
1727|007|Z|professional for complete information about this product and your||
1727|008|Z|specific health needs.||
1727|009|B|||
1727|010|T|ASPIRIN EXTENDED-RELEASE CAPSULE - ORAL||
1727|011|F|(AS-pir-in)||
1727|012|B|||
1727|013|C|COMMON BRAND NAME(S): Durlaza||
1727|014|B|||
1727|015|U|USES:  This medication is a low dose of aspirin used to reduce||
1727|016|U|the risk of having a heart attack in people who have heart||
1727|017|U|disease. It is also used to reduce the risk of stroke in people||
1727|018|U|who have previously had a stroke or "mini-stroke" (transient||
1727|019|U|ischemic attack). Aspirin is known as a salicylate and a||
1727|020|U|nonsteroidal anti-inflammatory drug (NSAID). This medication||
1727|021|U|works by stopping platelets from clumping together and forming||
1727|022|U|blood clots that can cause a heart attack or stroke.||
1727|023|U|   This medication is a long-acting form of aspirin and does not||
1727|024|U|work right away. Other forms of aspirin (immediate-release)||
1727|025|U|should be used when a fast effect is needed, such as right after||
1727|026|U|a heart attack or for pain relief.||
1727|027|B|||
1727|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
1727|029|H|doctor, usually once a day. Swallow the capsule whole. Do not||
1727|030|H|cut, crush, or chew the capsules. Doing so can release all of the||
1727|031|H|drug at once, increasing the risk of side effects. If stomach||
1727|032|H|upset occurs while taking this medication, take it with food or||
1727|033|H|milk.||
1727|034|H|   Take this medication by mouth with a full glass of water (8||
1727|035|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
1727|036|H|Do not lie down for at least 10 minutes after taking this||
1727|037|H|medication.||
1727|038|H|   Do not take this medication 2 hours before or 1 hour after||
1727|039|H|drinking alcoholic beverages.||
1727|040|H|   NSAIDs (such as ibuprofen, naproxen) may decrease aspirin's||
1727|041|H|ability to prevent heart attack/stroke. If you use a NSAID, take||
1727|042|H|it at least 8 hours before or at least 2 to 4 hours after this||
1727|043|H|medication (see also Drug Interactions section).||
1727|044|H|   Take this medication regularly to get the most benefit from||
1727|045|H|it. To help you remember, take it at the same time each day.||
1727|046|B|||
1727|047|S|SIDE EFFECTS:  Upset stomach or heartburn may occur. If either of||
1727|048|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1727|049|S|promptly.||
1727|050|S|   Remember that this medication has been prescribed because your||
1727|051|S|doctor has judged that the benefit to you is greater than the||
1727|052|S|risk of side effects. Many people using this medication do not||
1727|053|S|have serious side effects.||
1727|054|S|   Tell your doctor right away if you have any serious side||
1727|055|S|effects, including: easy bruising/bleeding, uncontrolled bleeding||
1727|056|S|from gums or nose, loss of appetite, dark urine, yellowing||
1727|057|S|eyes/skin, unusual tiredness, signs of kidney problems (such as||
1727|058|S|change in the amount of urine).||
1727|059|S|   This drug may rarely cause serious (rarely fatal) bleeding||
1727|060|S|from the stomach or intestines. If you notice any of the||
1727|061|S|following unlikely but serious side effects, stop taking this||
1727|062|S|medication and consult your doctor or pharmacist right away:||
1727|063|S|stomach/abdominal pain that doesn't go away, black stools, vomit||
1727|064|S|that looks like coffee grounds.||
1727|065|S|   A very serious allergic reaction to this drug is rare.||
1727|066|S|However, get medical help right away if you notice any symptoms||
1727|067|S|of a serious allergic reaction, including: fever, swollen lymph||
1727|068|S|nodes, rash, itching/swelling (especially of the||
1727|069|S|face/tongue/throat), severe dizziness, trouble breathing.||
1727|070|S|   This is not a complete list of possible side effects. If you||
1727|071|S|notice other effects not listed above, contact your doctor or||
1727|072|S|pharmacist.||
1727|073|S|   In the US -||
1727|074|S|   Call your doctor for medical advice about side effects. You||
1727|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1727|076|S|www.fda.gov/medwatch.||
1727|077|S|   In Canada - Call your doctor for medical advice about side||
1727|078|S|effects. You may report side effects to Health Canada at||
1727|079|S|1-866-234-2345.||
1727|080|B|||
1727|081|P|PRECAUTIONS:  Before taking aspirin, tell your doctor or||
1727|082|P|pharmacist if you are allergic to it; or to other salicylates||
1727|083|P|(such as choline salicylate); or to NSAIDs (such as ibuprofen,||
1727|084|P|naproxen); or if you have any other allergies. This product may||
1727|085|P|contain inactive ingredients, which can cause allergic reactions||
1727|086|P|or other problems. Talk to your pharmacist for more details.||
1727|087|P|   Before using this medication, tell your doctor or pharmacist||
1727|088|P|your medical history, especially of: asthma (including a history||
1727|089|P|of worsening breathing after taking aspirin or other NSAIDs),||
1727|090|P|bleeding/blood problems (such as hemophilia, vitamin K||
1727|091|P|deficiency, low platelets), kidney disease, liver disease,||
1727|092|P|stomach problems (such as ulcers, heartburn), growths in the nose||
1727|093|P|(nasal polyps).||
1727|094|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1727|095|P|and tobacco while using this medicine may increase your risk for||
1727|096|P|stomach bleeding. Limit alcohol and stop smoking. Ask your doctor||
1727|097|P|or pharmacist about how much alcohol you may safely drink.||
1727|098|P|   Before having surgery, tell your doctor or dentist about all||
1727|099|P|the products you use (including prescription drugs,||
1727|100|P|nonprescription drugs, and herbal products).||
1727|101|P|   This drug contains aspirin. Children and teenagers younger||
1727|102|P|than 18 should not take aspirin if they have chickenpox, flu, or||
1727|103|P|any undiagnosed illness or if they have recently received a||
1727|104|P|vaccine. In these cases, taking aspirin increases the risk of||
1727|105|P|Reye's syndrome, a rare but serious illness.||
1727|106|P|   Older adults may be more sensitive to the side effects of this||
1727|107|P|drug, especially stomach/intestinal bleeding and ulcers.||
1727|108|P|   Aspirin is not recommended for use to treat pain or fever||
1727|109|P|during pregnancy. Before using this medication, women of||
1727|110|P|childbearing age should talk with their doctor(s) about the||
1727|111|P|benefits and risks. Tell your doctor if you are pregnant or if||
1727|112|P|you plan to become pregnant. This medication may harm an unborn||
1727|113|P|baby and cause problems with normal labor/delivery. It is not||
1727|114|P|recommended for use in pregnancy from 20 weeks until delivery. If||
1727|115|P|your doctor decides that you need to use this medication between||
1727|116|P|20 and 30 weeks of pregnancy, you should use the lowest effective||
1727|117|P|dose for the shortest possible time. In some cases, low-dose||
1727|118|P|aspirin (usually 81-162 milligrams a day) may be used safely||
1727|119|P|during pregnancy to prevent certain conditions. Talk to your||
1727|120|P|doctor for more details.||
1727|121|P|   Aspirin passes into breast milk. When used in large amounts||
1727|122|P|(such as to treat pain or fever), it may harm a nursing infant||
1727|123|P|and breastfeeding is not recommended while using this medication.||
1727|124|P|However, low-dose aspirin for heart attack or stroke prevention||
1727|125|P|may be used if directed by your doctor. Consult your doctor||
1727|126|P|before breastfeeding.||
1727|127|B|||
1727|128|I|DRUG INTERACTIONS:  See also How to Use section.||
1727|129|I|   Drug interactions may change how your medications work or||
1727|130|I|increase your risk for serious side effects. This document does||
1727|131|I|not contain all possible drug interactions. Keep a list of all||
1727|132|I|the products you use (including prescription/nonprescription||
1727|133|I|drugs and herbal products) and share it with your doctor and||
1727|134|I|pharmacist. Do not start, stop, or change the dosage of any||
1727|135|I|medicines without your doctor's approval.||
1727|136|I|   Some products that may interact with this drug include:||
1727|137|I|mifepristone, other drugs that can cause bleeding/bruising||
1727|138|I|(including antiplatelet drugs such as clopidogrel, "blood||
1727|139|I|thinners" such as warfarin/dabigatran), corticosteroids (such as||
1727|140|I|prednisone), ginkgo biloba.||
1727|141|I|   Check all prescription and nonprescription medicine labels||
1727|142|I|carefully since many medications contain pain relievers/fever||
1727|143|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
1727|144|I|naproxen). These drugs are similar to this medication and may||
1727|145|I|increase your risk of side effects if taken together. Daily use||
1727|146|I|of NSAIDs may decrease aspirin's ability to prevent heart||
1727|147|I|attack/stroke. Ask your doctor or pharmacist for details.||
1727|148|I|   This medication may interfere with certain lab tests, possibly||
1727|149|I|causing false test results. Make sure lab personnel and all your||
1727|150|I|doctors know you use this drug.||
1727|151|B|||
1727|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1727|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1727|154|O|poison control center right away. US residents can call||
1727|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1727|156|O|Symptoms of overdose may include: ringing in the ears, sweating,||
1727|157|O|rapid breathing.||
1727|158|B|||
1727|159|N|NOTES:  Do not share this medication with others.||
1727|160|B|||
1727|161|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1727|162|D|remember. If it is near the time of the next dose, skip the||
1727|163|D|missed dose. Take your next dose at the regular time. Do not||
1727|164|D|double the dose to catch up.||
1727|165|B|||
1727|166|R|STORAGE:  Store at room temperature away from light and moisture.||
1727|167|R|Do not store in the bathroom. Keep all medications away from||
1727|168|R|children and pets.||
1727|169|R|   Do not flush medications down the toilet or pour them into a||
1727|170|R|drain unless instructed to do so. Properly discard this product||
1727|171|R|when it is expired or no longer needed. Consult your pharmacist||
1727|172|R|or local waste disposal company.||
1727|173|B|||
1727|174|A|Information last revised November 2025.||
1727|175|A|Copyright(c) 2025 First Databank, Inc.||
1727|176|B|||
1728|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1728|002|Z|does NOT have all possible information about this product. This||
1728|003|Z|information does not assure that this product is safe, effective,||
1728|004|Z|or appropriate for you. This information is not individual||
1728|005|Z|medical advice and does not substitute for the advice of your||
1728|006|Z|health care professional. Always ask your health care||
1728|007|Z|professional for complete information about this product and your||
1728|008|Z|specific health needs.||
1728|009|B|||
1728|010|T|ROLAPITANT - ORAL||
1728|011|F|(roe-LA-pi-tant)||
1728|012|B|||
1728|013|C|COMMON BRAND NAME(S): Varubi||
1728|014|B|||
1728|015|U|USES:  Rolapitant is used with other medications to help prevent||
1728|016|U|delayed nausea and vomiting caused by cancer drug treatment||
1728|017|U|(chemotherapy). It works by blocking one of the body's natural||
1728|018|U|substances (substance P/neurokinin 1) that causes vomiting.||
1728|019|U|   This drug is not recommended for use in children younger than||
1728|020|U|2 years due to risk of serious side effects.||
1728|021|B|||
1728|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1728|023|H|from your pharmacist before you start taking this medication and||
1728|024|H|each time you get a refill. If you have any questions, ask your||
1728|025|H|doctor or pharmacist.||
1728|026|H|   Take this medication by mouth with or without food as directed||
1728|027|H|by your doctor, usually within 2 hours before you receive your||
1728|028|H|chemotherapy. Do not take this medication more often than once||
1728|029|H|every 2 weeks.||
1728|030|H|   Tell your doctor if nausea or vomiting occurs.||
1728|031|B|||
1728|032|S|SIDE EFFECTS:  Stomach upset or mouth sores may occur. If either||
1728|033|S|of these effects lasts or gets worse, tell your doctor or||
1728|034|S|pharmacist promptly.||
1728|035|S|   Remember that this medication has been prescribed because your||
1728|036|S|doctor has judged that the benefit to you is greater than the||
1728|037|S|risk of side effects. Many people using this medication do not||
1728|038|S|have serious side effects.||
1728|039|S|   A very serious allergic reaction to this drug is rare.||
1728|040|S|However, get medical help right away if you notice any symptoms||
1728|041|S|of a serious allergic reaction, including: rash, itching/swelling||
1728|042|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1728|043|S|breathing.||
1728|044|S|   This is not a complete list of possible side effects. If you||
1728|045|S|notice other effects not listed above, contact your doctor or||
1728|046|S|pharmacist.||
1728|047|S|   In the US -||
1728|048|S|   Call your doctor for medical advice about side effects. You||
1728|049|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1728|050|S|www.fda.gov/medwatch.||
1728|051|S|   In Canada - Call your doctor for medical advice about side||
1728|052|S|effects. You may report side effects to Health Canada at||
1728|053|S|1-866-234-2345.||
1728|054|B|||
1728|055|P|PRECAUTIONS:  Before using rolapitant, tell your doctor or||
1728|056|P|pharmacist if you are allergic to it; or if you have any other||
1728|057|P|allergies. This product may contain inactive ingredients, which||
1728|058|P|can cause allergic reactions or other problems. Talk to your||
1728|059|P|pharmacist for more details.||
1728|060|P|   Before using this medication, tell your doctor or pharmacist||
1728|061|P|your medical history.||
1728|062|P|   Before having surgery, tell your doctor or dentist about all||
1728|063|P|the products you use (including prescription drugs,||
1728|064|P|nonprescription drugs, and herbal products).||
1728|065|P|   During pregnancy, this medication should be used only when||
1728|066|P|clearly needed. Discuss the risks and benefits with your doctor.||
1728|067|P|   It is unknown if this drug passes into breast milk. Consult||
1728|068|P|your doctor before breastfeeding.||
1728|069|B|||
1728|070|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1728|071|I|medications work or increase your risk for serious side effects.||
1728|072|I|This document does not contain all possible drug interactions.||
1728|073|I|Keep a list of all the products you use (including||
1728|074|I|prescription/nonprescription drugs and herbal products) and share||
1728|075|I|it with your doctor and pharmacist. Do not start, stop, or change||
1728|076|I|the dosage of any medicines without your doctor's approval.||
1728|077|I|   Rolapitant can slow down the removal of other medications from||
1728|078|I|your body, which may affect how they work. This effect can last 4||
1728|079|I|weeks or longer after your dose of rolapitant. Examples of||
1728|080|I|affected drugs include dextromethorphan, pimozide, thioridazine,||
1728|081|I|among others.||
1728|082|I|   Other medications can affect the removal of rolapitant from||
1728|083|I|your body, which may affect how rolapitant works. Examples||
1728|084|I|include rifamycins (such as rifampin, rifabutin), among others.||
1728|085|B|||
1728|086|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1728|087|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1728|088|O|poison control center right away. US residents can call||
1728|089|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1728|090|B|||
1728|091|N|NOTES:  Do not share this medication with others.||
1728|092|B|||
1728|093|D|MISSED DOSE:  It is important to take each dose of this||
1728|094|D|medication as scheduled. If you miss a dose, ask your doctor or||
1728|095|D|pharmacist right away for a new dosing schedule.||
1728|096|B|||
1728|097|R|STORAGE:  Store at room temperature away from light and moisture.||
1728|098|R|Do not store in the bathroom. Keep all medications away from||
1728|099|R|children and pets.||
1728|100|R|   Do not flush medications down the toilet or pour them into a||
1728|101|R|drain unless instructed to do so. Properly discard this product||
1728|102|R|when it is expired or no longer needed. Consult your pharmacist||
1728|103|R|or local waste disposal company.||
1728|104|B|||
1728|105|A|Information last revised May 2024.||
1728|106|A|Copyright(c) 2025 First Databank, Inc.||
1728|107|B|||
1729|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1729|002|Z|does NOT have all possible information about this product. This||
1729|003|Z|information does not assure that this product is safe, effective,||
1729|004|Z|or appropriate for you. This information is not individual||
1729|005|Z|medical advice and does not substitute for the advice of your||
1729|006|Z|health care professional. Always ask your health care||
1729|007|Z|professional for complete information about this product and your||
1729|008|Z|specific health needs.||
1729|009|B|||
1729|010|T|INSULIN DEGLUDEC - INJECTION||
1729|011|F|(IN-su-lin de-GLOO-dek)||
1729|012|B|||
1729|013|C|COMMON BRAND NAME(S): Tresiba, Tresiba FlexTouch||
1729|014|B|||
1729|015|U|USES:  Insulin degludec is used with a proper diet and exercise||
1729|016|U|program to control high blood sugar in people with diabetes.||
1729|017|U|Controlling high blood sugar helps prevent kidney damage,||
1729|018|U|blindness, nerve problems, loss of limbs, and sexual function||
1729|019|U|problems. Proper control of diabetes may also lessen your risk of||
1729|020|U|a heart attack or stroke.||
1729|021|U|   Insulin degludec is a man-made product that is similar to||
1729|022|U|human insulin. It replaces the insulin that your body would||
1729|023|U|normally make. It acts longer than regular insulin, providing a||
1729|024|U|low, steady level of insulin. It works by helping blood sugar||
1729|025|U|(glucose) get into cells so your body can use it for energy.||
1729|026|U|Insulin degludec may be used with a shorter-acting insulin||
1729|027|U|product. It may also be used alone or with other diabetes drugs.||
1729|028|B|||
1729|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1729|030|H|from your pharmacist before you start using this medication and||
1729|031|H|each time you get a refill. Ask your health care professional how||
1729|032|H|to prepare and use this medication. If you have any questions,||
1729|033|H|ask your doctor or pharmacist.||
1729|034|H|   Inject this medication under the skin as directed by your||
1729|035|H|doctor, usually once daily. The injection is given in the stomach||
1729|036|H|area, the thigh, or the upper arm. Do not inject into a vein or||
1729|037|H|muscle because very low blood sugar (hypoglycemia) may occur.||
1729|038|H|   The dosage is based on your medical condition and response to||
1729|039|H|treatment. Measure each dose very carefully because even small||
1729|040|H|changes in the amount of insulin may have a large effect on your||
1729|041|H|blood sugar.||
1729|042|H|   Before using, check this product for particles or||
1729|043|H|discoloration. If either is present, do not use the insulin. If||
1729|044|H|you are using the insulin vial, do not shake or roll it. Before||
1729|045|H|injecting each dose, clean the skin you are going to inject into||
1729|046|H|(the injection site) with rubbing alcohol. Change the injection||
1729|047|H|site each time to lessen injury under the skin (for example,||
1729|048|H|pits/lumps or thickened skin). Do not inject into skin that is||
1729|049|H|red, swollen, itchy, or damaged. To lessen bruising, do not rub||
1729|050|H|the injection site after a shot. Do not inject cold insulin||
1729|051|H|because this can be painful. Learn how to store and discard||
1729|052|H|medical supplies safely.||
1729|053|H|   This product should not be mixed with any other insulin. Do||
1729|054|H|not use insulin degludec in an infusion pump.||
1729|055|H|   Do not change brands or types of insulin without directions on||
1729|056|H|how to do so from your doctor.||
1729|057|H|   Do not share your pen device with another person, even if the||
1729|058|H|needle is changed. You may give other people a serious infection,||
1729|059|H|or get a serious infection from them.||
1729|060|H|   Use this medication regularly to get the most benefit from it.||
1729|061|H|To help you remember, use it at the same time each day.||
1729|062|H|   Tell your doctor if your condition does not get better or if||
1729|063|H|it gets worse (your blood sugar is too high or too low).||
1729|064|B|||
1729|065|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
1729|066|S|irritation) or weight gain may occur. If any of these effects||
1729|067|S|last or get worse, tell your doctor or pharmacist promptly.||
1729|068|S|   Remember that this medication has been prescribed because your||
1729|069|S|doctor has judged that the benefit to you is greater than the||
1729|070|S|risk of side effects. Many people using this medication do not||
1729|071|S|have serious side effects.||
1729|072|S|   Tell your doctor right away if you have any serious side||
1729|073|S|effects, including: signs of low potassium level in the blood||
1729|074|S|(such as muscle cramps, weakness, irregular heartbeat).||
1729|075|S|   This medication can cause low blood sugar (hypoglycemia). This||
1729|076|S|may occur if you do not get enough calories from food or if you||
1729|077|S|do unusually heavy exercise. Symptoms of low blood sugar include||
1729|078|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
1729|079|S|dizziness, or tingling hands/feet. It is a good habit to carry||
1729|080|S|glucose tablets or gel to treat low blood sugar. If you don't||
1729|081|S|have these reliable forms of glucose, rapidly raise your blood||
1729|082|S|sugar by eating a quick source of sugar such as table sugar,||
1729|083|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
1729|084|S|doctor right away about the reaction and the use of this product.||
1729|085|S|To help prevent low blood sugar, eat meals on a regular schedule,||
1729|086|S|and do not skip meals. Check with your doctor or pharmacist to||
1729|087|S|find out what you should do if you miss a meal.||
1729|088|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1729|089|S|thirst/urination. If these symptoms occur, tell your doctor right||
1729|090|S|away. Your doctor may need to adjust your diabetes medication,||
1729|091|S|exercise program, or diet.||
1729|092|S|   A very serious allergic reaction to this drug is rare.||
1729|093|S|However, get medical help right away if you notice any symptoms||
1729|094|S|of a serious allergic reaction, including: rash, itching/swelling||
1729|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1729|096|S|breathing.||
1729|097|S|   This is not a complete list of possible side effects. If you||
1729|098|S|notice other effects not listed above, contact your doctor or||
1729|099|S|pharmacist.||
1729|100|S|   In the US -||
1729|101|S|   Call your doctor for medical advice about side effects. You||
1729|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1729|103|S|www.fda.gov/medwatch.||
1729|104|S|   In Canada - Call your doctor for medical advice about side||
1729|105|S|effects. You may report side effects to Health Canada at||
1729|106|S|1-866-234-2345.||
1729|107|B|||
1729|108|P|PRECAUTIONS:  Before using insulin degludec, tell your doctor or||
1729|109|P|pharmacist if you are allergic to it; or if you have any other||
1729|110|P|allergies. This product may contain inactive ingredients, which||
1729|111|P|can cause allergic reactions or other problems. Talk to your||
1729|112|P|pharmacist for more details.||
1729|113|P|   Do not use this medication when you have low blood sugar||
1729|114|P|(hypoglycemia).||
1729|115|P|   Before using this medication, tell your doctor or pharmacist||
1729|116|P|your medical history, especially of: kidney disease, liver||
1729|117|P|disease.||
1729|118|P|   You may experience blurred vision, dizziness, or drowsiness||
1729|119|P|due to extremely low or high blood sugar. Do not drive, use||
1729|120|P|machinery, or do anything that needs alertness or clear vision||
1729|121|P|until you can do it safely.||
1729|122|P|   Limit alcohol while using this medication because it can||
1729|123|P|increase your risk of developing low blood sugar.||
1729|124|P|   It may be harder to control your blood sugar when your body is||
1729|125|P|stressed (such as due to fever, infection, injury, or surgery).||
1729|126|P|Consult your doctor because this may require a change in your||
1729|127|P|treatment plan, medications, or blood sugar testing.||
1729|128|P|   Before having surgery, tell your doctor or dentist about all||
1729|129|P|the products you use (including prescription drugs,||
1729|130|P|nonprescription drugs, and herbal products).||
1729|131|P|   Check your blood sugar before and after exercise. You may need||
1729|132|P|a snack beforehand.||
1729|133|P|   If traveling across time zones, ask your doctor about how to||
1729|134|P|adjust your insulin schedule. Take extra insulin and supplies||
1729|135|P|with you.||
1729|136|P|   Older adults may be more sensitive to the side effects of this||
1729|137|P|drug, especially low blood sugar.||
1729|138|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
1729|139|P|cause or worsen diabetes. Discuss a plan with your doctor for||
1729|140|P|managing your blood sugar while pregnant. Your doctor may change||
1729|141|P|your diabetes treatment during your pregnancy (such as diet and||
1729|142|P|medications including insulin).||
1729|143|P|   This medication passes into breast milk, but is unlikely to||
1729|144|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1729|145|P|Your insulin needs may change while breastfeeding.||
1729|146|B|||
1729|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1729|148|I|medications work or increase your risk for serious side effects.||
1729|149|I|This document does not contain all possible drug interactions.||
1729|150|I|Keep a list of all the products you use (including||
1729|151|I|prescription/nonprescription drugs and herbal products) and share||
1729|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
1729|153|I|the dosage of any medicines without your doctor's approval.||
1729|154|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1729|155|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1729|156|I|heartbeat you would usually feel when your blood sugar falls too||
1729|157|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1729|158|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1729|159|I|   Many drugs can affect your blood sugar levels, making it more||
1729|160|I|difficult to control your blood sugar. Before you start, stop, or||
1729|161|I|change any medication, talk with your doctor or pharmacist about||
1729|162|I|how the medication may affect your blood sugar. Check your blood||
1729|163|I|sugar regularly as directed by your doctor. Tell your doctor||
1729|164|I|about the results and of any symptoms of high or low blood sugar.||
1729|165|I|(See also Side Effects section.) Your doctor may need to adjust||
1729|166|I|your diabetes medication, exercise program, or diet.||
1729|167|B|||
1729|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1729|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1729|170|O|poison control center right away. US residents can call||
1729|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1729|172|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
1729|173|O|sweating, loss of consciousness.||
1729|174|B|||
1729|175|N|NOTES:  Do not share this medication with others.||
1729|176|N|   Attend a diabetes education program to learn more about how to||
1729|177|N|manage your diabetes with medications, diet, exercise, and||
1729|178|N|regular medical exams.||
1729|179|N|   Learn the symptoms of high and low blood sugar and how to||
1729|180|N|treat low blood sugar. Check your blood sugar regularly as||
1729|181|N|directed and share the results with your doctor.||
1729|182|N|   Lab and/or medical tests (such as liver/kidney function,||
1729|183|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
1729|184|N|should be done while you are using this medication. Keep all||
1729|185|N|medical and lab appointments.||
1729|186|N|   Keep extra supplies of insulin and needles on hand.||
1729|187|B|||
1729|188|D|MISSED DOSE:  It is very important to follow your insulin regimen||
1729|189|D|exactly. Ask your doctor ahead of time what you should do if you||
1729|190|D|miss a dose of insulin. Make sure there are at least 8 hours||
1729|191|D|between your doses.||
1729|192|B|||
1729|193|R|STORAGE:  It is best to refrigerate all unopened insulin||
1729|194|R|products. Unopened insulin degludec may also be stored at room||
1729|195|R|temperature, but it must be thrown away after 56 days. Opened||
1729|196|R|insulin degludec prefilled pens and vials may be stored in the||
1729|197|R|refrigerator or at room temperature. Opened insulin cartridges||
1729|198|R|must be stored at room temperature. Throw away all insulin||
1729|199|R|degludec in use after 56 days, even if there is insulin left.||
1729|200|R|Also throw away all insulin products after the expiration date on||
1729|201|R|the package. Do not freeze, and do not use insulin that has been||
1729|202|R|frozen.||
1729|203|R|   Protect insulin from light and heat. Do not store in the||
1729|204|R|bathroom. Keep all medications away from children and pets.||
1729|205|R|   Do not flush medications down the toilet or pour them into a||
1729|206|R|drain unless instructed to do so. Properly discard this product||
1729|207|R|when it is expired or no longer needed. Consult your pharmacist||
1729|208|R|or local waste disposal company.||
1729|209|B|||
1729|210|M|MEDICAL ALERT:  Your condition can cause complications in a||
1729|211|M|medical emergency. For information about enrolling in MedicAlert,||
1729|212|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1729|213|B|||
1729|214|A|Information last revised April 2025.||
1729|215|A|Copyright(c) 2025 First Databank, Inc.||
1729|216|B|||
1730|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1730|002|Z|does NOT have all possible information about this product. This||
1730|003|Z|information does not assure that this product is safe, effective,||
1730|004|Z|or appropriate for you. This information is not individual||
1730|005|Z|medical advice and does not substitute for the advice of your||
1730|006|Z|health care professional. Always ask your health care||
1730|007|Z|professional for complete information about this product and your||
1730|008|Z|specific health needs.||
1730|009|B|||
1730|010|T|IRINOTECAN LIPOSOMAL - INJECTION||
1730|011|F|(EYE-ri-noe-TEE-kan)||
1730|012|B|||
1730|013|C|COMMON BRAND NAME(S): Onivyde||
1730|014|B|||
1730|015|W|WARNING:  Irinotecan liposomal has caused a serious decrease in||
1730|016|W|white blood cells (neutropenia). Low white blood cells can make||
1730|017|W|you more likely to get serious (sometimes fatal) infections or||
1730|018|W|make any infection you have worse. Get medical help right away if||
1730|019|W|you develop signs of infection (such as sore throat that doesn't||
1730|020|W|go away, fever, chills).||
1730|021|W|   Your doctor will monitor your blood counts while you are using||
1730|022|W|this medication. Keep all medical and lab appointments.||
1730|023|W|   Irinotecan liposomal may cause severe (sometimes fatal)||
1730|024|W|diarrhea which may occur right away and/or more than 24 hours||
1730|025|W|after you receive the medication. If the diarrhea starts right||
1730|026|W|away, you may also have other side effects such as runny nose,||
1730|027|W|increased saliva, watery eyes, sweating, slow heartbeat, stomach||
1730|028|W|cramps, or flushing. Drinking plenty of fluids and eating several||
1730|029|W|small, low-fat meals may help lower your risk of severe diarrhea.||
1730|030|W|You should not receive this medication if you have||
1730|031|W|stomach/intestinal blockage. Tell your doctor right away if you||
1730|032|W|have diarrhea. Your doctor may temporarily stop this medication||
1730|033|W|and will prescribe other medications to help control the||
1730|034|W|diarrhea.||
1730|035|B|||
1730|036|U|USES:  Irinotecan liposomal is used to treat cancer of the||
1730|037|U|pancreas.||
1730|038|B|||
1730|039|H|HOW TO USE:  This medication is given by a health care||
1730|040|H|professional. It is injected slowly into a vein over 90 minutes||
1730|041|H|as directed by your doctor, usually every 2 weeks. The dosage is||
1730|042|H|based on your medical condition, body size, and response to||
1730|043|H|treatment. To help prevent side effects such as nausea/vomiting,||
1730|044|H|your doctor may direct you to take other medications before you||
1730|045|H|receive this medication. Use these additional medications exactly||
1730|046|H|as directed by your doctor.||
1730|047|B|||
1730|048|S|SIDE EFFECTS:  See also Warning section.||
1730|049|S|   Nausea, vomiting, loss of appetite, weight loss, mouth sores,||
1730|050|S|or tiredness may occur. Nausea and vomiting can be severe. In||
1730|051|S|some cases, your doctor may prescribe medication to prevent or||
1730|052|S|relieve nausea and vomiting. Eating several small meals, not||
1730|053|S|eating before treatment, or limiting activity may help lessen||
1730|054|S|some of these effects. If any of these effects last or get worse,||
1730|055|S|tell your doctor or pharmacist promptly.||
1730|056|S|   Temporary hair loss may occur. Normal hair growth should||
1730|057|S|return after treatment has ended.||
1730|058|S|   Remember that this medication has been prescribed because your||
1730|059|S|doctor has judged that the benefit to you is greater than the||
1730|060|S|risk of side effects. Many people using this medication do not||
1730|061|S|have serious side effects.||
1730|062|S|   Tell your doctor right away if you have any serious side||
1730|063|S|effects, including: symptoms of lung disease (such as shortness||
1730|064|S|of breath, cough), signs of kidney problems (such as change in||
1730|065|S|the amount of urine), easy bruising/bleeding, unusual tiredness,||
1730|066|S|extreme thirst, dizziness, fainting, irregular heartbeat,||
1730|067|S|mental/mood changes, muscle cramps/weakness,||
1730|068|S|pain/redness/swelling at the injection site or arms/legs,||
1730|069|S|black/bloody stools.||
1730|070|S|   Get medical help right away if you have any very serious side||
1730|071|S|effects, including: chest pain, weakness on one side of the body,||
1730|072|S|confusion.||
1730|073|S|   A very serious allergic reaction to this drug is rare.||
1730|074|S|However, get medical help right away if you notice any symptoms||
1730|075|S|of a serious allergic reaction, including: rash, itching/swelling||
1730|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1730|077|S|breathing.||
1730|078|S|   This is not a complete list of possible side effects. If you||
1730|079|S|notice other effects not listed above, contact your doctor or||
1730|080|S|pharmacist.||
1730|081|S|   In the US -||
1730|082|S|   Call your doctor for medical advice about side effects. You||
1730|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1730|084|S|www.fda.gov/medwatch.||
1730|085|S|   In Canada - Call your doctor for medical advice about side||
1730|086|S|effects. You may report side effects to Health Canada at||
1730|087|S|1-866-234-2345.||
1730|088|B|||
1730|089|P|PRECAUTIONS:  Before using irinotecan liposomal, tell your doctor||
1730|090|P|or pharmacist if you are allergic to it; or if you have any other||
1730|091|P|allergies. This product may contain inactive ingredients, which||
1730|092|P|can cause allergic reactions or other problems. Talk to your||
1730|093|P|pharmacist for more details.||
1730|094|P|   Before using this medication, tell your doctor or pharmacist||
1730|095|P|your medical history, especially of: stomach/intestinal blockage,||
1730|096|P|blood/bone marrow disorders (such as low platelet/white blood||
1730|097|P|cell/red blood cell levels), lung disease.||
1730|098|P|   Before having surgery, tell your doctor or dentist about all||
1730|099|P|the products you use (including prescription drugs,||
1730|100|P|nonprescription drugs, and herbal products).||
1730|101|P|   Irinotecan liposomal can make you more likely to get||
1730|102|P|infections or may make current infections worse. Stay away from||
1730|103|P|anyone who has an infection that may easily spread (such as||
1730|104|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
1730|105|P|have been exposed to an infection or for more details.||
1730|106|P|   Tell your health care professional that you are using||
1730|107|P|irinotecan liposomal before having any||
1730|108|P|immunizations/vaccinations. Avoid contact with people who have||
1730|109|P|recently received live vaccines (such as flu vaccine inhaled||
1730|110|P|through the nose).||
1730|111|P|   To lower the chance of getting cut, bruised, or injured, use||
1730|112|P|caution with sharp objects like razors and nail cutters, and||
1730|113|P|avoid activities such as contact sports.||
1730|114|P|   Tell your doctor if you are pregnant or plan to become||
1730|115|P|pregnant. You should not become pregnant while using this||
1730|116|P|medication. Irinotecan liposomal may harm an unborn baby. Women||
1730|117|P|using this medication should ask about reliable forms of birth||
1730|118|P|control during treatment and for some time after the last dose.||
1730|119|P|Men using this medication should ask about reliable forms of||
1730|120|P|birth control during treatment and for 4 months after the last||
1730|121|P|dose. If you or your partner becomes pregnant, talk to your||
1730|122|P|doctor right away about the risks and benefits of this||
1730|123|P|medication.||
1730|124|P|   It is unknown if this drug passes into breast milk. Because of||
1730|125|P|the possible risk to the infant, breastfeeding is not recommended||
1730|126|P|while using this drug and for 1 month after the last dose.||
1730|127|P|Consult your doctor before breastfeeding.||
1730|128|B|||
1730|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1730|130|I|medications work or increase your risk for serious side effects.||
1730|131|I|This document does not contain all possible drug interactions.||
1730|132|I|Keep a list of all the products you use (including||
1730|133|I|prescription/nonprescription drugs and herbal products) and share||
1730|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
1730|135|I|the dosage of any medicines without your doctor's approval.||
1730|136|I|   Other medications can affect the removal of irinotecan||
1730|137|I|liposomal from your body, which may affect how irinotecan||
1730|138|I|liposomal works. Examples include adagrasib, azole antifungals||
1730|139|I|(such as itraconazole, ketoconazole), clarithromycin,||
1730|140|I|gemfibrozil, nefazodone, HIV protease inhibitors (such as||
1730|141|I|atazanavir), rifamycins (such as rifabutin), ritonavir, St.||
1730|142|I|John's wort, drugs used to treat seizures (such as carbamazepine,||
1730|143|I|phenytoin), among others.||
1730|144|B|||
1730|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1730|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1730|147|O|poison control center right away. US residents can call||
1730|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1730|149|B|||
1730|150|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1730|151|N|kidney/liver function, blood mineral levels) should be done while||
1730|152|N|you are using this medication. Keep all medical and lab||
1730|153|N|appointments. Consult your doctor for more details.||
1730|154|B|||
1730|155|D|MISSED DOSE:  It is important to get each dose of this medication||
1730|156|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1730|157|D|right away for a new dosing schedule.||
1730|158|B|||
1730|159|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1730|160|R|doctor's office and will not be stored at home.||
1730|161|R|   Do not flush medications down the toilet or pour them into a||
1730|162|R|drain unless instructed to do so. Properly discard this product||
1730|163|R|when it is expired or no longer needed. Consult your pharmacist||
1730|164|R|or local waste disposal company.||
1730|165|B|||
1730|166|M|MEDICAL ALERT:  Your condition can cause complications in a||
1730|167|M|medical emergency. For information about enrolling in MedicAlert,||
1730|168|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1730|169|B|||
1730|170|A|Information last revised April 2025.||
1730|171|A|Copyright(c) 2025 First Databank, Inc.||
1730|172|B|||
1731|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1731|002|Z|does NOT have all possible information about this product. This||
1731|003|Z|information does not assure that this product is safe, effective,||
1731|004|Z|or appropriate for you. This information is not individual||
1731|005|Z|medical advice and does not substitute for the advice of your||
1731|006|Z|health care professional. Always ask your health care||
1731|007|Z|professional for complete information about this product and your||
1731|008|Z|specific health needs.||
1731|009|B|||
1731|010|T|BENZOCAINE - TOPICAL||
1731|011|F|(BEN-zoe-kane)||
1731|012|B|||
1731|013|C|COMMON BRAND NAME(S): Americaine, Boil Ease||
1731|014|B|||
1731|015|U|USES:  This medication is used on the skin to stop itching and||
1731|016|U|pain from certain skin conditions (such as scrapes, minor burns,||
1731|017|U|insect bites) and to treat minor discomfort and itching caused by||
1731|018|U|hemorrhoids and certain other problems of the genital/anal area||
1731|019|U|(such as anal fissures, itching around the vagina/rectum).||
1731|020|U|Benzocaine is a local anesthetic that works by causing temporary||
1731|021|U|numbness/loss of feeling in the skin.||
1731|022|B|||
1731|023|H|HOW TO USE:  If you are using the over-the-counter product to||
1731|024|H|self-treat, read all directions on the product package before||
1731|025|H|using this medication. If you have any questions, consult your||
1731|026|H|pharmacist. If your doctor has prescribed this medication, use it||
1731|027|H|as directed.||
1731|028|H|   Before use, clean and dry the affected area as directed. Apply||
1731|029|H|a thin layer of medication to the affected area of skin as||
1731|030|H|directed.||
1731|031|H|   If you are using the spray, shake the can well before using.||
1731|032|H|Hold the can 6 to 12 inches (15 to 30 centimeters) from the||
1731|033|H|affected area and spray until wet. Do not spray near your eyes,||
1731|034|H|nose, or mouth.||
1731|035|H|   Do not use on large areas of the body, cover the area with||
1731|036|H|waterproof bandages or plastic, or apply heat unless directed to||
1731|037|H|do so by your doctor. Doing so may increase the risk of serious||
1731|038|H|side effects.||
1731|039|H|   Wash your hands right after use unless you are treating an||
1731|040|H|area on the hands. Avoid getting the product in your eyes, nose,||
1731|041|H|or mouth. If the medication gets in these areas, rinse right away||
1731|042|H|with plenty of water.||
1731|043|H|   The dosage is based on your medical condition and response to||
1731|044|H|treatment. Do not use more of this product, use it more often, or||
1731|045|H|use it longer than directed.||
1731|046|H|   If your condition lasts or gets worse, or if you think you may||
1731|047|H|have a serious medical problem, get medical help right away.||
1731|048|B|||
1731|049|S|SIDE EFFECTS:  Temporary redness, stinging, or irritation at the||
1731|050|S|application site may occur. If any of these effects last or get||
1731|051|S|worse, tell your doctor or pharmacist promptly.||
1731|052|S|   If your doctor has directed you to use this medication,||
1731|053|S|remember that your doctor has judged that the benefit to you is||
1731|054|S|greater than the risk of side effects. Many people using this||
1731|055|S|medication do not have serious side effects.||
1731|056|S|   Get medical help right away if you have any very serious side||
1731|057|S|effects, including: slow/shallow breathing, slow/irregular||
1731|058|S|heartbeat, seizures.||
1731|059|S|   This medication has rarely caused a very serious (possibly||
1731|060|S|fatal) blood disorder (methemoglobinemia). This effect is more||
1731|061|S|likely if you have breathing problems, certain diseases of the||
1731|062|S|blood, or if you smoke (see also Precautions section). The||
1731|063|S|symptoms of this disorder may occur within minutes to a couple of||
1731|064|S|hours after using this medication. Stop using this medication and||
1731|065|S|get medical help right away if you develop any symptoms of||
1731|066|S|methemoglobinemia, including: pale/bluish/gray skin, unusual||
1731|067|S|tiredness, shortness of breath, fast heartbeat, dizziness,||
1731|068|S|headache, confusion.||
1731|069|S|   A very serious allergic reaction to this drug is rare.||
1731|070|S|However, get medical help right away if you notice any symptoms||
1731|071|S|of a serious allergic reaction, including: rash, new or worsening||
1731|072|S|itching/swelling (especially of the face/tongue/throat), severe||
1731|073|S|dizziness, trouble breathing.||
1731|074|S|   This is not a complete list of possible side effects. If you||
1731|075|S|notice any other effects not listed above, contact your doctor or||
1731|076|S|pharmacist.||
1731|077|S|   In the US -||
1731|078|S|   Call your doctor for medical advice about side effects. You||
1731|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1731|080|S|www.fda.gov/medwatch.||
1731|081|S|   In Canada - Call your doctor for medical advice about side||
1731|082|S|effects. You may report side effects to Health Canada at||
1731|083|S|1-866-234-2345.||
1731|084|B|||
1731|085|P|PRECAUTIONS:  Before using benzocaine, tell your doctor or||
1731|086|P|pharmacist if you are allergic to it; or to other "caine"||
1731|087|P|anesthetics (such as procaine); or if you have any other||
1731|088|P|allergies. This product may contain inactive ingredients, which||
1731|089|P|can cause allergic reactions or other problems. Talk to your||
1731|090|P|pharmacist for more details.||
1731|091|P|   Before using this medication, tell your doctor or pharmacist||
1731|092|P|your medical history, especially of: broken skin/infection in the||
1731|093|P|affected area, heart disease, certain blood disorders (G6PD||
1731|094|P|deficiency, pyruvate kinase deficiency, hemoglobin-M disease,||
1731|095|P|NADH-methemoglobin reductase deficiency), breathing problems||
1731|096|P|(such as asthma, bronchitis, emphysema, smoking history).||
1731|097|P|   Before having surgery, tell your doctor or dentist about all||
1731|098|P|the products you use (including prescription drugs,||
1731|099|P|nonprescription drugs, and herbal products).||
1731|100|P|   During pregnancy, this medication should be used only when||
1731|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
1731|102|P|   It is unknown if this medication passes into breast milk.||
1731|103|P|Consult your doctor before breastfeeding.||
1731|104|B|||
1731|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1731|106|I|medications work or increase your risk for serious side effects.||
1731|107|I|This document does not contain all possible drug interactions.||
1731|108|I|Keep a list of all the products you use (including||
1731|109|I|prescription/nonprescription drugs and herbal products) and share||
1731|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
1731|111|I|the dosage of any medicines without your doctor's approval.||
1731|112|B|||
1731|113|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1731|114|O|has overdosed and has serious symptoms such as passing out or||
1731|115|O|trouble breathing, call 911. Otherwise, call a poison control||
1731|116|O|center right away. US residents can call 1-800-222-1222. Canada||
1731|117|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1731|118|O|include: irregular heartbeat, seizures.||
1731|119|B|||
1731|120|N|NOTES:  Keep all medical and lab appointments.||
1731|121|B|||
1731|122|D|MISSED DOSE:  If you are using this product on a regular schedule||
1731|123|D|and miss a dose, use it as soon as you remember. If it is near||
1731|124|D|the time of the next dose, skip the missed dose. Use your next||
1731|125|D|dose at the regular time. Do not double the dose to catch up.||
1731|126|B|||
1731|127|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
1731|128|R|medications away from children and pets.||
1731|129|R|   Do not flush medications down the toilet or pour them into a||
1731|130|R|drain unless instructed to do so. Properly discard this product||
1731|131|R|when it is expired or no longer needed. Consult your pharmacist||
1731|132|R|or local waste disposal company.||
1731|133|B|||
1731|134|A|Information last revised February 2025.||
1731|135|A|Copyright(c) 2025 First Databank, Inc.||
1731|136|B|||
1732|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1732|002|Z|does NOT have all possible information about this product. This||
1732|003|Z|information does not assure that this product is safe, effective,||
1732|004|Z|or appropriate for you. This information is not individual||
1732|005|Z|medical advice and does not substitute for the advice of your||
1732|006|Z|health care professional. Always ask your health care||
1732|007|Z|professional for complete information about this product and your||
1732|008|Z|specific health needs.||
1732|009|B|||
1732|010|T|TALIMOGENE LAHERPAREPVEC - INJECTION||
1732|011|F|(tal-IM-oh-jeen la-HER-pa-REP-vek)||
1732|012|B|||
1732|013|C|COMMON BRAND NAME(S): Imlygic||
1732|014|B|||
1732|015|U|USES:  This medication is used to treat a certain type of skin||
1732|016|U|cancer (melanoma). It contains a live virus (cold sore virus)||
1732|017|U|that has been weakened. Talimogene laherparepvec infects the||
1732|018|U|cancer cells and works by slowing or stopping their growth.||
1732|019|B|||
1732|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1732|021|H|pharmacist before you start using talimogene laherparepvec and||
1732|022|H|each time you get a treatment. If you have any questions, ask||
1732|023|H|your doctor or pharmacist.||
1732|024|H|   This medication is given by injection into your tumor(s) by a||
1732|025|H|health care professional. It is given as directed by your doctor,||
1732|026|H|usually every 2 weeks. However, your second treatment should be 3||
1732|027|H|weeks after your first treatment.||
1732|028|H|   The dosage is based on your medical condition and response to||
1732|029|H|treatment.||
1732|030|H|   After getting this medication, you may be able to make others||
1732|031|H|sick with the cold sore virus. To prevent the spread of||
1732|032|H|infection, do not touch or scratch the injection site(s). Keep||
1732|033|H|the injection site(s) covered with airtight and watertight||
1732|034|H|dressing(s) for at least 1 week after each treatment. If the||
1732|035|H|injection site is still oozing or weeping after 1 week, you will||
1732|036|H|need to keep it covered for longer. Ask your doctor for more||
1732|037|H|details. If the dressing comes loose or falls off, replace it||
1732|038|H|right away with a clean dressing. Always wear gloves when||
1732|039|H|changing the dressing. Throw away all used dressings and medical||
1732|040|H|supplies in a sealed plastic bag.||
1732|041|H|   Since you may be able to make others sick with the cold sore||
1732|042|H|virus, people close to you (such as household members,||
1732|043|H|caregivers, sexual partners) should not touch your injection||
1732|044|H|site(s), dressing(s), and body fluids. Caregivers should wear||
1732|045|H|gloves when changing the dressing. Women who are pregnant or who||
1732|046|H|may become pregnant and people with weakened immune systems||
1732|047|H|should not change your dressing or clean your injection site. If||
1732|048|H|someone touches your injection site(s), dressing(s), or body||
1732|049|H|fluids, they should clean the skin that touched you with a||
1732|050|H|disinfectant or soap and water right away. If they have any signs||
1732|051|H|of infection (such as cold sores), they should tell their doctor||
1732|052|H|right away.||
1732|053|H|   Use this medication regularly to get the most benefit from it.||
1732|054|H|To help you remember, mark your calendar with a reminder.||
1732|055|B|||
1732|056|S|SIDE EFFECTS:  Diarrhea, constipation, abdominal pain, dizziness,||
1732|057|S|pain at injection site, white patches on the skin, or flu-like||
1732|058|S|symptoms (such as body aches, cough, sneezing, chills, fever,||
1732|059|S|unusual tiredness, headache, nausea, vomiting) may occur. If any||
1732|060|S|of these effects last or get worse, tell your doctor or||
1732|061|S|pharmacist promptly.||
1732|062|S|   Remember that this medication has been prescribed because your||
1732|063|S|doctor has judged that the benefit to you is greater than the||
1732|064|S|risk of side effects. Many people using this medication do not||
1732|065|S|have serious side effects.||
1732|066|S|   Tell your doctor right away if you have any serious side||
1732|067|S|effects, including: cold sores/blisters, eye infection (such as||
1732|068|S|vision changes, eye redness/pain, light sensitivity, eye||
1732|069|S|discharge), open sore/wound at the injection site, slow wound||
1732|070|S|healing at the injection site, signs of kidney problems (such as||
1732|071|S|change in the amount of urine, pink/bloody urine), joint pain,||
1732|072|S|muscle pain.||
1732|073|S|   Get medical help right away if you have any very serious side||
1732|074|S|effects, including: trouble breathing.||
1732|075|S|   A very serious allergic reaction to this drug is rare.||
1732|076|S|However, get medical help right away if you notice any symptoms||
1732|077|S|of a serious allergic reaction, including: rash, itching/swelling||
1732|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1732|079|S|breathing.||
1732|080|S|   This is not a complete list of possible side effects. If you||
1732|081|S|notice other effects not listed above, contact your doctor or||
1732|082|S|pharmacist.||
1732|083|S|   In the US -||
1732|084|S|   Call your doctor for medical advice about side effects. You||
1732|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1732|086|S|www.fda.gov/medwatch.||
1732|087|S|   In Canada - Call your doctor for medical advice about side||
1732|088|S|effects. You may report side effects to Health Canada at||
1732|089|S|1-866-234-2345.||
1732|090|B|||
1732|091|P|PRECAUTIONS:  Before using talimogene laherparepvec, tell your||
1732|092|P|doctor or pharmacist if you are allergic to it; or if you have||
1732|093|P|any other allergies. This product may contain inactive||
1732|094|P|ingredients, which can cause allergic reactions or other||
1732|095|P|problems. Talk to your pharmacist for more details.||
1732|096|P|   Before using this medication, tell your doctor or pharmacist||
1732|097|P|your medical history, especially of: immune system problems (such||
1732|098|P|as HIV infection, autoimmune disease), certain types of cancer||
1732|099|P|(such as leukemia, lymphoma, multiple myeloma), psoriasis.||
1732|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1732|101|P|can make you more dizzy. Do not drive, use machinery, or do||
1732|102|P|anything that needs alertness until you can do it safely. Limit||
1732|103|P|alcoholic beverages. Talk to your doctor if you are using||
1732|104|P|marijuana (cannabis).||
1732|105|P|   Before having surgery, tell your doctor or dentist about all||
1732|106|P|the products you use (including prescription drugs,||
1732|107|P|nonprescription drugs, and herbal products).||
1732|108|P|   This medication must not be used during pregnancy. It may harm||
1732|109|P|an unborn baby. Discuss the use of reliable forms of birth||
1732|110|P|control (such as condoms, birth control pills) with your doctor.||
1732|111|P|Men and women should use condoms to prevent spreading the cold||
1732|112|P|sore virus to their sexual partner. If you become pregnant or||
1732|113|P|think you may be pregnant, tell your doctor right away. See also||
1732|114|P|How to Use section.||
1732|115|P|   It is unknown if this drug passes into breast milk. Because of||
1732|116|P|the possible risk to the infant, breastfeeding is not recommended||
1732|117|P|while using this drug. Consult your doctor before breastfeeding.||
1732|118|B|||
1732|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1732|120|I|medications work or increase your risk for serious side effects.||
1732|121|I|This document does not contain all possible drug interactions.||
1732|122|I|Keep a list of all the products you use (including||
1732|123|I|prescription/nonprescription drugs and herbal products) and share||
1732|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
1732|125|I|the dosage of any medicines without your doctor's approval.||
1732|126|I|   Some products that may interact with this drug include: drugs||
1732|127|I|that weaken the immune system/increase the risk of infection||
1732|128|I|(such as natalizumab, rituximab, prednisone).||
1732|129|B|||
1732|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1732|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1732|132|O|poison control center right away. US residents can call||
1732|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1732|134|B|||
1732|135|N|NOTES:  Do not share this medication with others.||
1732|136|B|||
1732|137|D|MISSED DOSE:  It is important to get each dose of this medication||
1732|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1732|139|D|right away for a new dosing schedule. Do not double the dose to||
1732|140|D|catch up.||
1732|141|B|||
1732|142|R|STORAGE:  Not applicable. This medication is given in a clinic||
1732|143|R|and will not be stored at home.||
1732|144|B|||
1732|145|A|Information last revised October 2024.||
1732|146|A|Copyright(c) 2025 First Databank, Inc.||
1732|147|B|||
1733|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1733|002|Z|does NOT have all possible information about this product. This||
1733|003|Z|information does not assure that this product is safe, effective,||
1733|004|Z|or appropriate for you. This information is not individual||
1733|005|Z|medical advice and does not substitute for the advice of your||
1733|006|Z|health care professional. Always ask your health care||
1733|007|Z|professional for complete information about this product and your||
1733|008|Z|specific health needs.||
1733|009|B|||
1733|010|T|OSIMERTINIB - ORAL||
1733|011|F|(OH-sim-ER-ti-nib)||
1733|012|B|||
1733|013|C|COMMON BRAND NAME(S): Tagrisso||
1733|014|B|||
1733|015|U|USES:  This medication is used to treat lung cancer. Osimertinib||
1733|016|U|belongs to a class of drugs known as kinase inhibitors. It works||
1733|017|U|by slowing or stopping the growth of cancer cells. It binds to a||
1733|018|U|certain protein (epidermal growth factor receptor-EGFR) in some||
1733|019|U|tumors.||
1733|020|B|||
1733|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1733|022|H|from your pharmacist before you start taking osimertinib and each||
1733|023|H|time you get a refill. If you have any questions, ask your doctor||
1733|024|H|or pharmacist.||
1733|025|H|   Take this medication by mouth with or without food as directed||
1733|026|H|by your doctor, usually once daily.||
1733|027|H|   If you have trouble swallowing the tablet whole, place the||
1733|028|H|tablet into a container with a small amount of non-carbonated||
1733|029|H|water (2 ounces/60 milliliters). Stir well until the tablet||
1733|030|H|breaks into small pieces. The tablet will not completely||
1733|031|H|dissolve. Do not crush the tablet or heat the mixture. Drink all||
1733|032|H|of the mixture right away. Add at least another half a glass of||
1733|033|H|water (4 ounces/120 milliliters) to the container and drink all||
1733|034|H|of the mixture to make sure you are getting all of the drug. Use||
1733|035|H|only non-carbonated water for mixing, and do not prepare a supply||
1733|036|H|in advance. The mixture may also be given through a tube into the||
1733|037|H|stomach (nasogastric tube). If you are giving this medication||
1733|038|H|through a nasogastric tube, ask your health care professional for||
1733|039|H|detailed instructions on how to give it.||
1733|040|H|   The dosage is based on your medical condition and response to||
1733|041|H|treatment.||
1733|042|H|   Use this medication regularly to get the most benefit from it.||
1733|043|H|To help you remember, take it at the same time each day.||
1733|044|H|   Do not increase your dose or use this drug more often or for||
1733|045|H|longer than prescribed. Your condition will not improve any||
1733|046|H|faster, and your risk of serious side effects will increase.||
1733|047|B|||
1733|048|S|SIDE EFFECTS:  Diarrhea, mouth sores, dry/itchy skin, tiredness,||
1733|049|S|back pain, headache, or loss of appetite may occur. If any of||
1733|050|S|these effects last or get worse, tell your doctor or pharmacist||
1733|051|S|promptly.||
1733|052|S|   Remember that this medication has been prescribed because your||
1733|053|S|doctor has judged that the benefit to you is greater than the||
1733|054|S|risk of side effects. Many people using this medication do not||
1733|055|S|have serious side effects.||
1733|056|S|   Tell your doctor right away if you have any serious side||
1733|057|S|effects, such as: easy bruising/bleeding, changes in your nails||
1733|058|S|(such as nail tenderness/irritation/redness, change in nail||
1733|059|S|color), signs of eye disease (such as vision changes, eye||
1733|060|S|redness/pain, light sensitivity, eye discharge), signs of low||
1733|061|S|level of sodium in the blood (such as nausea, extreme drowsiness,||
1733|062|S|mental/mood changes, seizures).||
1733|063|S|   Get medical help right away if you have any very serious side||
1733|064|S|effects, such as: slow/fast/irregular heartbeat, severe||
1733|065|S|dizziness, fainting, slow/shallow breathing, symptoms of heart||
1733|066|S|failure (such as swelling ankles/feet, unusual tiredness,||
1733|067|S|unusual/sudden weight gain), new or worsening symptoms of lung||
1733|068|S|disease (such as shortness of breath, chest pain, cough, fever),||
1733|069|S|signs of blood clots (such as pain/swelling/warmth in the||
1733|070|S|groin/calf).||
1733|071|S|   This medication may lower your ability to fight infections.||
1733|072|S|This may make you more likely to get a serious (rarely fatal)||
1733|073|S|infection or make any infection you have worse. Tell your doctor||
1733|074|S|right away if you have any signs of infections (such as sore||
1733|075|S|throat that doesn't go away, fever, chills).||
1733|076|S|   A very serious allergic reaction to this drug is rare.||
1733|077|S|However, get medical help right away if you notice any symptoms||
1733|078|S|of a serious allergic reaction, such as: rash, itching/swelling||
1733|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1733|080|S|breathing.||
1733|081|S|   This is not a complete list of possible side effects. If you||
1733|082|S|notice other effects not listed above, contact your doctor or||
1733|083|S|pharmacist.||
1733|084|S|   In the US -||
1733|085|S|   Call your doctor for medical advice about side effects. You||
1733|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1733|087|S|www.fda.gov/medwatch.||
1733|088|S|   In Canada - Call your doctor for medical advice about side||
1733|089|S|effects. You may report side effects to Health Canada at||
1733|090|S|1-866-234-2345.||
1733|091|B|||
1733|092|P|PRECAUTIONS:  Before taking osimertinib, tell your doctor or||
1733|093|P|pharmacist if you are allergic to it; or if you have any other||
1733|094|P|allergies. This product may contain inactive ingredients, which||
1733|095|P|can cause allergic reactions or other problems. Talk to your||
1733|096|P|pharmacist for more details.||
1733|097|P|   Before using this medication, tell your doctor or pharmacist||
1733|098|P|your medical history.||
1733|099|P|   Osimertinib may cause a condition that affects the heart||
1733|100|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1733|101|P|serious (rarely fatal) fast/irregular heartbeat and other||
1733|102|P|symptoms (such as severe dizziness, fainting) that need medical||
1733|103|P|attention right away.||
1733|104|P|   The risk of QT prolongation may be increased if you have||
1733|105|P|certain medical conditions or are taking other drugs that may||
1733|106|P|cause QT prolongation. Before using osimertinib, tell your doctor||
1733|107|P|or pharmacist of all the drugs you take and if you have any of||
1733|108|P|the following conditions: certain heart problems (heart failure,||
1733|109|P|slow heartbeat, QT prolongation in the EKG), family history of||
1733|110|P|certain heart problems (QT prolongation in the EKG, sudden||
1733|111|P|cardiac death).||
1733|112|P|   Low levels of potassium or magnesium in the blood may also||
1733|113|P|increase your risk of QT prolongation. This risk may increase if||
1733|114|P|you use certain drugs (such as diuretics/"water pills") or if you||
1733|115|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1733|116|P|Talk to your doctor about using osimertinib safely.||
1733|117|P|   This drug may cause blurred vision. Do not drive, use||
1733|118|P|machinery, or do anything that needs clear vision until you can||
1733|119|P|do it safely. Limit alcoholic beverages.||
1733|120|P|   Osimertinib can make you more likely to get infections or may||
1733|121|P|make current infections worse. Stay away from anyone who has an||
1733|122|P|infection that may easily spread (such as chickenpox, COVID-19,||
1733|123|P|measles, flu). Talk to your doctor if you have been exposed to an||
1733|124|P|infection or for more details.||
1733|125|P|   Tell your health care professional that you are using||
1733|126|P|osimertinib before having any immunizations/vaccinations. Avoid||
1733|127|P|contact with people who have recently received live vaccines||
1733|128|P|(such as flu vaccine inhaled through the nose).||
1733|129|P|   To lower the chance of getting cut, bruised, or injured, use||
1733|130|P|caution with sharp objects like razors and nail cutters, and||
1733|131|P|avoid activities such as contact sports.||
1733|132|P|   Before having surgery, tell your doctor or dentist about all||
1733|133|P|the products you use (including prescription drugs,||
1733|134|P|nonprescription drugs, and herbal products).||
1733|135|P|   Older adults may be more sensitive to the side effects of this||
1733|136|P|drug, especially QT prolongation (see above).||
1733|137|P|   Tell your doctor if you are pregnant or plan to become||
1733|138|P|pregnant. You should not become pregnant while using osimertinib.||
1733|139|P|Osimertinib may harm an unborn baby. Your doctor should order a||
1733|140|P|pregnancy test before you start this medication. Women using this||
1733|141|P|medication should ask about reliable forms of birth control||
1733|142|P|during treatment and for 6 weeks after the last dose. Men using||
1733|143|P|this medication should ask about reliable forms of birth control||
1733|144|P|during treatment and for 4 months after the last dose. If you or||
1733|145|P|your partner becomes pregnant, talk to your doctor right away||
1733|146|P|about the risks and benefits of this medication.||
1733|147|P|   It is unknown if this drug passes into breast milk. Because of||
1733|148|P|the possible risk to the infant, breastfeeding is not recommended||
1733|149|P|while using this drug and for 2 weeks after the last dose.||
1733|150|P|Consult your doctor before breastfeeding.||
1733|151|B|||
1733|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1733|153|I|medications work or increase your risk for serious side effects.||
1733|154|I|This document does not contain all possible drug interactions.||
1733|155|I|Keep a list of all the products you use (including||
1733|156|I|prescription/nonprescription drugs and herbal products) and share||
1733|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
1733|158|I|the dosage of any medicines without your doctor's approval.||
1733|159|B|||
1733|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1733|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1733|162|O|poison control center right away. US residents can call||
1733|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1733|164|B|||
1733|165|N|NOTES:  Do not share this medication with others.||
1733|166|N|   Lab and/or medical tests (such as heart imaging, complete||
1733|167|N|blood count) should be done before you start taking this||
1733|168|N|medication and while you are taking it. Keep all medical and lab||
1733|169|N|appointments. Consult your doctor for more details.||
1733|170|B|||
1733|171|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1733|172|D|next dose at the regular time. Do not double the dose to catch||
1733|173|D|up.||
1733|174|B|||
1733|175|R|STORAGE:  Store at room temperature away from light and moisture.||
1733|176|R|Do not store in the bathroom. Keep all medications away from||
1733|177|R|children and pets.||
1733|178|R|   Do not flush medications down the toilet or pour them into a||
1733|179|R|drain unless instructed to do so. Properly discard this product||
1733|180|R|when it is expired or no longer needed. Consult your pharmacist||
1733|181|R|or local waste disposal company.||
1733|182|B|||
1733|183|A|Information last revised April 2025.||
1733|184|A|Copyright(c) 2025 First Databank, Inc.||
1733|185|B|||
1734|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1734|002|Z|does NOT have all possible information about this product. This||
1734|003|Z|information does not assure that this product is safe, effective,||
1734|004|Z|or appropriate for you. This information is not individual||
1734|005|Z|medical advice and does not substitute for the advice of your||
1734|006|Z|health care professional. Always ask your health care||
1734|007|Z|professional for complete information about this product and your||
1734|008|Z|specific health needs.||
1734|009|B|||
1734|010|T|COBIMETINIB - ORAL||
1734|011|F|(KOE-bi-ME-ti-nib)||
1734|012|B|||
1734|013|C|COMMON BRAND NAME(S): Cotellic||
1734|014|B|||
1734|015|U|USES:  Cobimetinib is used to treat a type of skin cancer||
1734|016|U|(melanoma). It is also used to treat a certain group of blood||
1734|017|U|cancers (histiocytic neoplasms). It works by slowing or stopping||
1734|018|U|the growth of cancer cells.||
1734|019|B|||
1734|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1734|021|H|from your pharmacist before you start taking cobimetinib and each||
1734|022|H|time you get a refill. If you have any questions, ask your doctor||
1734|023|H|or pharmacist.||
1734|024|H|   Take this medication by mouth with or without food as directed||
1734|025|H|by your doctor, usually once daily for 21 days, then stopping the||
1734|026|H|medication for 7 days. This is one cycle of treatment. Keep||
1734|027|H|taking the medication this way as directed by your doctor.||
1734|028|H|   If you vomit after taking a dose, do not take another dose at||
1734|029|H|that time. Take your next dose at the regular time.||
1734|030|H|   The dosage is based on your medical condition, response to||
1734|031|H|treatment, and other medications you may be taking. Be sure to||
1734|032|H|tell your doctor and pharmacist about all the products you use||
1734|033|H|(including prescription drugs, nonprescription drugs, and herbal||
1734|034|H|products).||
1734|035|H|   Take this medication regularly to get the most benefit from||
1734|036|H|it. To help you remember, take it at the same time each day.||
1734|037|H|   Do not increase your dose or use this drug more often or for||
1734|038|H|longer than prescribed. Your condition will not improve any||
1734|039|H|faster, and your risk of side effects will increase.||
1734|040|H|   Since this drug can be absorbed through the skin and lungs and||
1734|041|H|may harm an unborn baby, women who are pregnant or who may become||
1734|042|H|pregnant should not handle this medication or breathe the dust||
1734|043|H|from the tablets.||
1734|044|B|||
1734|045|S|SIDE EFFECTS:  Diarrhea, nausea, or vomiting may occur. If any of||
1734|046|S|these effects last or get worse, tell your doctor or pharmacist||
1734|047|S|promptly.||
1734|048|S|   Pain or sores in the mouth and throat may occur. Brush your||
1734|049|S|teeth carefully/gently, avoid using mouthwash that contains||
1734|050|S|alcohol, and rinse your mouth often with cool water mixed with||
1734|051|S|baking soda or salt. It may also be best to eat soft, moist||
1734|052|S|foods.||
1734|053|S|   People using this medication may have serious side effects.||
1734|054|S|However, you have been prescribed this drug because your doctor||
1734|055|S|has judged that the benefit to you is greater than the risk of||
1734|056|S|side effects. Careful monitoring by your doctor may decrease your||
1734|057|S|risk.||
1734|058|S|   This medication may raise your blood pressure. Check your||
1734|059|S|blood pressure regularly and tell your doctor if the results are||
1734|060|S|high.||
1734|061|S|   Tell your doctor right away if you have any serious side||
1734|062|S|effects, including: unusual skin changes (such as skin||
1734|063|S|sores/lumps, warts, change in the size/color of a mole), easy||
1734|064|S|bleeding/bruising (such as bleeding of the gums), unusual vaginal||
1734|065|S|bleeding, black/bloody stools, vomit that contains blood or looks||
1734|066|S|like coffee grounds, blood in the urine, muscle||
1734|067|S|pain/tenderness/weakness, signs of kidney problems (such as||
1734|068|S|change in the amount of urine), signs of heart failure (such as||
1734|069|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
1734|070|S|unusual/sudden weight gain), vision changes (such as blurred||
1734|071|S|vision, vision loss, seeing halos), signs of liver disease (such||
1734|072|S|as nausea/vomiting that doesn't stop, loss of appetite,||
1734|073|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1734|074|S|   Get medical help right away if you have any very serious side||
1734|075|S|effects, including: signs of bleeding in the brain (such as||
1734|076|S|severe headache, weakness on one side of the body, sudden vision||
1734|077|S|changes, trouble speaking, seizures, confusion).||
1734|078|S|   A very serious allergic reaction to this drug is rare.||
1734|079|S|However, get medical help right away if you notice any symptoms||
1734|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1734|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1734|082|S|breathing.||
1734|083|S|   This is not a complete list of possible side effects. If you||
1734|084|S|notice other effects not listed above, contact your doctor or||
1734|085|S|pharmacist.||
1734|086|S|   In the US -||
1734|087|S|   Call your doctor for medical advice about side effects. You||
1734|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1734|089|S|www.fda.gov/medwatch.||
1734|090|S|   In Canada - Call your doctor for medical advice about side||
1734|091|S|effects. You may report side effects to Health Canada at||
1734|092|S|1-866-234-2345.||
1734|093|B|||
1734|094|P|PRECAUTIONS:  Before taking cobimetinib, tell your doctor or||
1734|095|P|pharmacist if you are allergic to it; or if you have any other||
1734|096|P|allergies. This product may contain inactive ingredients, which||
1734|097|P|can cause allergic reactions or other problems. Talk to your||
1734|098|P|pharmacist for more details.||
1734|099|P|   Before using this medication, tell your doctor or pharmacist||
1734|100|P|your medical history, especially of: bleeding problems, high||
1734|101|P|blood pressure, heart disease (heart failure), eye problems,||
1734|102|P|liver disease.||
1734|103|P|   This drug may cause blurred vision. Do not drive, use||
1734|104|P|machinery, or do anything that needs clear vision until you can||
1734|105|P|do it safely. Limit alcoholic beverages.||
1734|106|P|   This medication may make you more sensitive to the sun. Limit||
1734|107|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1734|108|P|sunscreen/lip balm and wear protective clothing when outdoors.||
1734|109|P|Tell your doctor right away if you get sunburned or have skin||
1734|110|P|blisters/redness.||
1734|111|P|   Before having surgery, tell your doctor or dentist about all||
1734|112|P|the products you use (including prescription drugs,||
1734|113|P|nonprescription drugs, and herbal products).||
1734|114|P|   Since this drug can be absorbed through the skin and lungs and||
1734|115|P|may harm an unborn baby, women who are pregnant or who may become||
1734|116|P|pregnant should not handle this medication or breathe the dust||
1734|117|P|from the tablets.||
1734|118|P|   Tell your doctor if you are pregnant or plan to become||
1734|119|P|pregnant. You should not become pregnant while using cobimetinib.||
1734|120|P|Cobimetinib may harm an unborn baby. Ask about reliable forms of||
1734|121|P|birth control while using this medication and for 2 weeks after||
1734|122|P|the last dose. If you become pregnant, talk to your doctor right||
1734|123|P|away about the risks and benefits of this medication.||
1734|124|P|   It is unknown if this drug passes into breast milk. Because of||
1734|125|P|the possible risk to the infant, breastfeeding is not recommended||
1734|126|P|while using this drug and for 2 weeks after the last dose.||
1734|127|P|Consult your doctor before breastfeeding.||
1734|128|B|||
1734|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1734|130|I|medications work or increase your risk for serious side effects.||
1734|131|I|This document does not contain all possible drug interactions.||
1734|132|I|Keep a list of all the products you use (including||
1734|133|I|prescription/nonprescription drugs and herbal products) and share||
1734|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
1734|135|I|the dosage of any medicines without your doctor's approval.||
1734|136|I|   Other medications can affect the removal of cobimetinib from||
1734|137|I|your body, which may affect how cobimetinib works. Examples||
1734|138|I|include azole antifungals (such as itraconazole), efavirenz,||
1734|139|I|rifamycins (such as rifampin), St. John's wort, drugs used to||
1734|140|I|treat seizures (such as carbamazepine, phenytoin), among others.||
1734|141|B|||
1734|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1734|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1734|144|O|poison control center right away. US residents can call||
1734|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1734|146|B|||
1734|147|N|NOTES:  Do not share this medication with others.||
1734|148|N|   Lab and/or medical tests (such as BRAF testing, heart/liver||
1734|149|N|function, skin/eye exams, CPK/creatinine levels, complete blood||
1734|150|N|count, blood mineral levels, blood pressure) should be done||
1734|151|N|before you start taking this medication and while you are taking||
1734|152|N|it. Keep all medical and lab appointments. Consult your doctor||
1734|153|N|for more details.||
1734|154|B|||
1734|155|D|MISSED DOSE:  It is important to take this medication as||
1734|156|D|scheduled. If you miss a dose, contact your doctor or pharmacist||
1734|157|D|for instructions. Do not double the dose to catch up.||
1734|158|B|||
1734|159|R|STORAGE:  Store at room temperature away from light and moisture.||
1734|160|R|Keep all medications away from children and pets.||
1734|161|R|   Do not flush medications down the toilet or pour them into a||
1734|162|R|drain unless instructed to do so. Properly discard this product||
1734|163|R|when it is expired or no longer needed. Consult your pharmacist||
1734|164|R|or local waste disposal company.||
1734|165|B|||
1734|166|A|Information last revised April 2025.||
1734|167|A|Copyright(c) 2025 First Databank, Inc.||
1734|168|B|||
1735|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1735|002|Z|does NOT have all possible information about this product. This||
1735|003|Z|information does not assure that this product is safe, effective,||
1735|004|Z|or appropriate for you. This information is not individual||
1735|005|Z|medical advice and does not substitute for the advice of your||
1735|006|Z|health care professional. Always ask your health care||
1735|007|Z|professional for complete information about this product and your||
1735|008|Z|specific health needs.||
1735|009|B|||
1735|010|T|ELUXADOLINE - ORAL||
1735|011|F|(EL-ux-AD-oh-leen)||
1735|012|B|||
1735|013|C|COMMON BRAND NAME(S): Viberzi||
1735|014|B|||
1735|015|U|USES:  This medication is used to treat a certain||
1735|016|U|stomach/abdominal disorder (irritable bowel syndrome with||
1735|017|U|diarrhea, or IBS-D). It works by slowing down the motion in your||
1735|018|U|gut. This effect helps lessen symptoms such as belly pain and||
1735|019|U|diarrhea.||
1735|020|B|||
1735|021|H|HOW TO USE:  Read the Medication Guide provided by your||
1735|022|H|pharmacist before you start taking eluxadoline and each time you||
1735|023|H|get a refill. If you have any questions, ask your doctor or||
1735|024|H|pharmacist.||
1735|025|H|   Take this medication by mouth with food as directed by your||
1735|026|H|doctor, usually 2 times a day. The dosage is based on your||
1735|027|H|medical condition, response to treatment, and other medications||
1735|028|H|you may be taking. Be sure to tell your doctor and pharmacist||
1735|029|H|about all the products you use (including prescription drugs,||
1735|030|H|nonprescription drugs, and herbal products). Do not increase your||
1735|031|H|dose or use this drug more often or for longer than prescribed.||
1735|032|H|Your condition will not improve any faster, and your risk of side||
1735|033|H|effects will increase. Properly stop the medication when so||
1735|034|H|directed.||
1735|035|H|   Use this medication regularly to get the most benefit from it.||
1735|036|H|To help you remember, take it at the same times each day.||
1735|037|H|   If you are also taking loperamide to help control diarrhea, do||
1735|038|H|not take it on a regular schedule or you may become constipated.||
1735|039|H|However, you may take it occasionally if needed for severe||
1735|040|H|diarrhea. If you develop constipation, stop taking loperamide and||
1735|041|H|tell your doctor right away.||
1735|042|H|   Though it helps many people, this medication may sometimes||
1735|043|H|cause addiction. This risk may be higher if you have a substance||
1735|044|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1735|045|H|Take this medication exactly as prescribed to lower the risk of||
1735|046|H|addiction. Ask your doctor or pharmacist for more details.||
1735|047|H|   Tell your doctor if you do not get better or if you get worse.||
1735|048|B|||
1735|049|S|SIDE EFFECTS:  Constipation, nausea, vomiting, abdominal pain, or||
1735|050|S|drowsiness may occur. If any of these effects last or get worse,||
1735|051|S|tell your doctor or pharmacist right away. If you have severe||
1735|052|S|constipation, stop taking eluxadoline and tell your doctor or||
1735|053|S|pharmacist right away.||
1735|054|S|   Remember that this medication has been prescribed because your||
1735|055|S|doctor has judged that the benefit to you is greater than the||
1735|056|S|risk of side effects. Many people using this medication do not||
1735|057|S|have serious side effects.||
1735|058|S|   Tell your doctor right away if you have any serious side||
1735|059|S|effects, including: symptoms of pancreatitis or sphincter of Oddi||
1735|060|S|spasm (such as nausea/vomiting that doesn't stop, new or suddenly||
1735|061|S|worse stomach/abdominal pain that may move to your back or||
1735|062|S|shoulder).||
1735|063|S|   A very serious allergic reaction to this drug is rare.||
1735|064|S|However, get medical help right away if you notice any symptoms||
1735|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1735|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1735|067|S|breathing.||
1735|068|S|   This is not a complete list of possible side effects. If you||
1735|069|S|notice other effects not listed above, contact your doctor or||
1735|070|S|pharmacist.||
1735|071|S|   In the US -||
1735|072|S|   Call your doctor for medical advice about side effects. You||
1735|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1735|074|S|www.fda.gov/medwatch.||
1735|075|S|   In Canada - Call your doctor for medical advice about side||
1735|076|S|effects. You may report side effects to Health Canada at||
1735|077|S|1-866-234-2345.||
1735|078|B|||
1735|079|P|PRECAUTIONS:  Before taking eluxadoline, tell your doctor or||
1735|080|P|pharmacist if you are allergic to it; or if you have any other||
1735|081|P|allergies. This product may contain inactive ingredients, which||
1735|082|P|can cause allergic reactions or other problems. Talk to your||
1735|083|P|pharmacist for more details.||
1735|084|P|   Before using this medication, tell your doctor or pharmacist||
1735|085|P|your medical history, especially of: personal or family history||
1735|086|P|of a substance use disorder (such as overuse of or addiction to||
1735|087|P|drugs/alcohol), gallbladder removal surgery, liver disease,||
1735|088|P|kidney disease, pancreatitis, other stomach/abdominal problems||
1735|089|P|(such as blockage, sphincter of Oddi disease/dysfunction,||
1735|090|P|previous long-lasting or severe constipation).||
1735|091|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
1735|092|P|can make you more drowsy. Do not drive, use machinery, or do||
1735|093|P|anything that needs alertness until you can do it safely. Limit||
1735|094|P|alcoholic beverages. Talk to your doctor if you are using||
1735|095|P|marijuana (cannabis). Drinking a lot of alcohol while taking this||
1735|096|P|medication may increase the risk of pancreatitis.||
1735|097|P|   Before having surgery, tell your doctor or dentist about all||
1735|098|P|the products you use (including prescription drugs,||
1735|099|P|nonprescription drugs, and herbal products).||
1735|100|P|   Older adults may be more sensitive to the side effects of this||
1735|101|P|drug, especially constipation or stomach/abdominal pain.||
1735|102|P|   During pregnancy, this medication should be used only when||
1735|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
1735|104|P|   It is unknown if eluxadoline passes into breast milk. Consult||
1735|105|P|your doctor before breastfeeding.||
1735|106|B|||
1735|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1735|108|I|medications work or increase your risk for serious side effects.||
1735|109|I|This document does not contain all possible drug interactions.||
1735|110|I|Keep a list of all the products you use (including||
1735|111|I|prescription/nonprescription drugs and herbal products) and share||
1735|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
1735|113|I|the dosage of any medicines without your doctor's approval.||
1735|114|B|||
1735|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1735|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1735|117|O|poison control center right away. US residents can call||
1735|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1735|119|B|||
1735|120|N|NOTES:  Do not share this medication with others. Sharing it is||
1735|121|N|against the law.||
1735|122|N|   Lab tests (such as liver function, lipase levels) may be done||
1735|123|N|while you are taking this medication. Keep all medical and lab||
1735|124|N|appointments.||
1735|125|B|||
1735|126|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1735|127|D|remember. If it is near the time of the next dose, skip the||
1735|128|D|missed dose. Take your next dose at the regular time. Do not||
1735|129|D|double the dose to catch up.||
1735|130|B|||
1735|131|R|STORAGE:  Store at room temperature away from light and moisture.||
1735|132|R|Do not store in the bathroom. Keep this medicine in a safe place||
1735|133|R|to prevent theft, misuse, or abuse. Keep all medications away||
1735|134|R|from children and pets.||
1735|135|R|   Do not flush medications down the toilet or pour them into a||
1735|136|R|drain unless instructed to do so. Properly discard this product||
1735|137|R|when it is expired or no longer needed. Consult your pharmacist||
1735|138|R|or local waste disposal company.||
1735|139|B|||
1735|140|A|Information last revised January 2025.||
1735|141|A|Copyright(c) 2025 First Databank, Inc.||
1735|142|B|||
1736|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1736|002|Z|does NOT have all possible information about this product. This||
1736|003|Z|information does not assure that this product is safe, effective,||
1736|004|Z|or appropriate for you. This information is not individual||
1736|005|Z|medical advice and does not substitute for the advice of your||
1736|006|Z|health care professional. Always ask your health care||
1736|007|Z|professional for complete information about this product and your||
1736|008|Z|specific health needs.||
1736|009|B|||
1736|010|T|BUPRENORPHINE FILM - BUCCAL||
1736|011|F|(BUE-pre-NOR-feen)||
1736|012|B|||
1736|013|C|COMMON BRAND NAME(S): Belbuca||
1736|014|B|||
1736|015|W|WARNING:  Buprenorphine has a risk for abuse and addiction, which||
1736|016|W|can lead to overdose and death. Buprenorphine may also cause||
1736|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
1736|018|W|your doctor should have you use the smallest dose of||
1736|019|W|buprenorphine that works, and use it for the shortest possible||
1736|020|W|time. See also How to Use section for more information about||
1736|021|W|addiction.||
1736|022|W|   Ask your doctor or pharmacist if you should have medication||
1736|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1736|024|W|Teach your family or household members about the signs of an||
1736|025|W|opioid overdose and how to treat it.||
1736|026|W|   The risk for severe breathing problems is higher when you||
1736|027|W|start this medication and after a dose increase, or if you use||
1736|028|W|the wrong dose/strength. Using this medication with alcohol or||
1736|029|W|other drugs that can cause drowsiness or breathing problems may||
1736|030|W|cause very serious side effects, including death. Be sure you||
1736|031|W|know how to use buprenorphine and what other drugs you should||
1736|032|W|avoid taking with it. See also Drug Interactions section. Get||
1736|033|W|medical help right away if any of these very serious side effects||
1736|034|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
1736|035|W|drowsiness/dizziness, difficulty waking up.||
1736|036|W|   Do not chew or swallow the film. Also, do not inject the||
1736|037|W|medication in the film. Chewing or swallowing the film or||
1736|038|W|injecting the buprenorphine in the film may cause a fatal||
1736|039|W|overdose.||
1736|040|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1736|041|W|or abuse. If someone accidentally swallows or uses this drug, get||
1736|042|W|medical help right away.||
1736|043|W|   Before using this medication, women of childbearing age should||
1736|044|W|talk with their doctor(s) about the risks and benefits. Tell your||
1736|045|W|doctor if you are pregnant or if you plan to become pregnant.||
1736|046|W|During pregnancy, this medication should be used only when||
1736|047|W|clearly needed. It may slightly increase the risk of birth||
1736|048|W|defects if used during the first two months of pregnancy. Also,||
1736|049|W|using it for a long time or in high doses near the expected||
1736|050|W|delivery date may harm the unborn baby. To lessen the risk, use||
1736|051|W|the smallest effective dose for the shortest possible time.||
1736|052|W|Babies born to mothers who use this drug for a long time may||
1736|053|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1736|054|W|doctor right away if you notice any symptoms in your newborn baby||
1736|055|W|such as crying that doesn't stop, slow/shallow breathing,||
1736|056|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1736|057|W|difficulty gaining weight.||
1736|058|B|||
1736|059|U|USES:  Buprenorphine is used to help relieve severe ongoing pain.||
1736|060|U|Buprenorphine belongs to a class of drugs known as opioid||
1736|061|U|analgesics. It works in the brain to change how your body feels||
1736|062|U|and responds to pain.||
1736|063|U|   Do not use this medication to relieve pain that is mild or||
1736|064|U|that will go away in a few days. This medication is not for||
1736|065|U|occasional ("as needed") use.||
1736|066|B|||
1736|067|H|HOW TO USE:  See also Warning section.||
1736|068|H|   Read the Medication Guide provided by your pharmacist before||
1736|069|H|you start using buprenorphine and each time you get a refill.||
1736|070|H|Follow the illustrated directions for the proper use of this||
1736|071|H|medication. If you have any questions, ask your doctor or||
1736|072|H|pharmacist.||
1736|073|H|   Use this medication on a regular schedule as directed by your||
1736|074|H|doctor, not as needed for sudden (breakthrough) pain. Use this||
1736|075|H|medication in the mouth as directed by your doctor, usually every||
1736|076|H|12 hours. To reduce your risk of side effects, your doctor may||
1736|077|H|direct you to use this medication every 24 hours when you start||
1736|078|H|this medication and gradually increase to every 12 hours. Follow||
1736|079|H|your doctor's instructions carefully.||
1736|080|H|   Before using, rinse your mouth with water or use your tongue||
1736|081|H|to wet the inside of your cheek. Use the tip of a dry finger to||
1736|082|H|place one film inside your mouth with the yellow side facing||
1736|083|H|against one cheek. Press and hold the film in place for 5||
1736|084|H|seconds, then remove your finger. The film should stay in place||
1736|085|H|on its own after this. Leave it in place until it is dissolved.||
1736|086|H|Do not move the film with your tongue/finger or drink or eat food||
1736|087|H|until the film has completely dissolved. If your doctor directs||
1736|088|H|you to use more than one film at the same time, do not place one||
1736|089|H|on top of the other. Place one film on each side of your mouth.||
1736|090|H|Do not place the film over open sores or lesions on the inside||
1736|091|H|your cheek.||
1736|092|H|   After the medication is fully dissolved, take a large sip of||
1736|093|H|water and swish gently around your teeth and gums, and then||
1736|094|H|swallow the water. This will help to prevent problems with your||
1736|095|H|teeth. Do not brush your teeth for at least one hour after using||
1736|096|H|this medication.||
1736|097|H|   Do not use the film if it is cut, damaged, or changed in any||
1736|098|H|way.||
1736|099|H|   The dosage is based on your medical condition and response to||
1736|100|H|treatment. Do not increase your dose or use this drug more often||
1736|101|H|or for longer than prescribed, because your risk of side effects||
1736|102|H|may increase. Properly stop the medication when so directed.||
1736|103|H|   Pain medications work best if they are used as the first signs||
1736|104|H|of pain occur. If you wait until the pain has worsened, the||
1736|105|H|medication may not work as well.||
1736|106|H|   Before you start using this medication, ask your doctor or||
1736|107|H|pharmacist if you should stop or change how you use your other||
1736|108|H|opioid medication(s). Other pain relievers (such as||
1736|109|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1736|110|H|or pharmacist about using buprenorphine safely with other drugs.||
1736|111|H|   Suddenly stopping this medication may cause withdrawal,||
1736|112|H|especially if you have used it for a long time or in high doses.||
1736|113|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1736|114|H|Tell your doctor or pharmacist right away if you have any||
1736|115|H|withdrawal symptoms such as restlessness, mental/mood changes||
1736|116|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1736|117|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1736|118|H|aches, or sudden changes in behavior.||
1736|119|H|   When this medication is used for a long time, it may not work||
1736|120|H|as well. Talk with your doctor if this medication stops working||
1736|121|H|well.||
1736|122|H|   Though it helps many people, this medication may sometimes||
1736|123|H|cause addiction. This risk may be higher if you have a||
1736|124|H|mental/mood disorder or a substance use disorder (such as overuse||
1736|125|H|of or addiction to drugs/alcohol). Use this medication exactly as||
1736|126|H|prescribed to lower the risk of addiction. Ask your doctor or||
1736|127|H|pharmacist for more details.||
1736|128|H|   Tell your doctor if your pain does not get better or if it||
1736|129|H|gets worse, or if you have any new pain.||
1736|130|B|||
1736|131|S|SIDE EFFECTS:  See also Warning section.||
1736|132|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
1736|133|S|drowsiness may occur. Some of these side effects may decrease||
1736|134|S|after you have been using this medication for a while. If any of||
1736|135|S|these effects last or get worse, tell your doctor or pharmacist||
1736|136|S|promptly.||
1736|137|S|   To prevent constipation, eat dietary fiber, drink enough||
1736|138|S|water, and exercise. You may also need to take a laxative. Ask||
1736|139|S|your pharmacist which type of laxative is right for you.||
1736|140|S|   To reduce the risk of dizziness and lightheadedness, get up||
1736|141|S|slowly when rising from a sitting or lying position.||
1736|142|S|   Remember that this medication has been prescribed because your||
1736|143|S|doctor has judged that the benefit to you is greater than the||
1736|144|S|risk of side effects. Many people using this medication do not||
1736|145|S|have serious side effects.||
1736|146|S|   Tell your doctor right away if you have any serious side||
1736|147|S|effects, including: interrupted breathing during sleep (sleep||
1736|148|S|apnea), mental/mood changes (such as agitation, confusion,||
1736|149|S|hallucinations), stomach/abdominal pain, tooth/gum pain,||
1736|150|S|difficulty urinating, signs of your adrenal glands not working||
1736|151|S|well (such as unusual tiredness, weight loss), trouble||
1736|152|S|swallowing.||
1736|153|S|   Get medical help right away if you have any very serious side||
1736|154|S|effects, including: fainting, fast/irregular heartbeat, severe||
1736|155|S|dizziness, seizures, slow/shallow breathing, severe||
1736|156|S|drowsiness/difficulty waking up.||
1736|157|S|   Buprenorphine may rarely cause serious (possibly fatal) liver||
1736|158|S|disease. Get medical help right away if you have any symptoms of||
1736|159|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1736|160|S|of appetite, severe stomach/abdominal pain, yellowing eyes/skin,||
1736|161|S|dark urine.||
1736|162|S|   A very serious allergic reaction to this drug is rare.||
1736|163|S|However, get medical help right away if you notice any symptoms||
1736|164|S|of a serious allergic reaction, including: rash, itching/swelling||
1736|165|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1736|166|S|breathing.||
1736|167|S|   This is not a complete list of possible side effects. If you||
1736|168|S|notice other effects not listed above, contact your doctor or||
1736|169|S|pharmacist.||
1736|170|S|   In the US -||
1736|171|S|   Call your doctor for medical advice about side effects. You||
1736|172|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1736|173|S|www.fda.gov/medwatch.||
1736|174|S|   In Canada - Call your doctor for medical advice about side||
1736|175|S|effects. You may report side effects to Health Canada at||
1736|176|S|1-866-234-2345.||
1736|177|B|||
1736|178|P|PRECAUTIONS:  Before using buprenorphine, tell your doctor or||
1736|179|P|pharmacist if you are allergic to it; or if you have any other||
1736|180|P|allergies. This product may contain inactive ingredients, which||
1736|181|P|can cause allergic reactions or other problems. Talk to your||
1736|182|P|pharmacist for more details.||
1736|183|P|   Before using this medication, tell your doctor or pharmacist||
1736|184|P|your medical history, especially of: brain disorders (such as||
1736|185|P|head injury, tumor, seizures), breathing problems (such as||
1736|186|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1736|187|P|gallbladder disease, kidney disease, liver disease, mental/mood||
1736|188|P|disorders (such as confusion, depression, thoughts of suicide),||
1736|189|P|personal or family history of a substance use disorder (such as||
1736|190|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
1736|191|P|problems (such as blockage, constipation, diarrhea due to||
1736|192|P|infection, paralytic ileus), disease of the pancreas||
1736|193|P|(pancreatitis), difficulty urinating (such as due to enlarged||
1736|194|P|prostate), mouth sores/blisters.||
1736|195|P|   Buprenorphine may cause a condition that affects the heart||
1736|196|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1736|197|P|serious (rarely fatal) fast/irregular heartbeat and other||
1736|198|P|symptoms (such as severe dizziness, fainting) that need medical||
1736|199|P|attention right away.||
1736|200|P|   The risk of QT prolongation may be increased if you have||
1736|201|P|certain medical conditions or are taking other drugs that may||
1736|202|P|cause QT prolongation. Before using buprenorphine, tell your||
1736|203|P|doctor or pharmacist of all the drugs you take and if you have||
1736|204|P|any of the following conditions: certain heart problems (heart||
1736|205|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1736|206|P|history of certain heart problems (QT prolongation in the EKG,||
1736|207|P|sudden cardiac death).||
1736|208|P|   Low levels of potassium or magnesium in the blood may also||
1736|209|P|increase your risk of QT prolongation. This risk may increase if||
1736|210|P|you use certain drugs (such as diuretics/"water pills") or if you||
1736|211|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1736|212|P|Talk to your doctor about using buprenorphine safely.||
1736|213|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1736|214|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1736|215|P|machinery, or do anything that needs alertness until you can do||
1736|216|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1736|217|P|are using marijuana (cannabis).||
1736|218|P|   Some people using this medication may have dental problems||
1736|219|P|(such as tooth decay/loss, cavities, infection). Schedule a visit||
1736|220|P|to the dentist soon after starting this medication and tell your||
1736|221|P|dentist that you are using this medication. To help prevent||
1736|222|P|dental problems, have regular dental exams and learn how to keep||
1736|223|P|your teeth and gums healthy. If you have tooth or gum pain, tell||
1736|224|P|your doctor and dentist right away.||
1736|225|P|   Before having surgery, tell your doctor or dentist about all||
1736|226|P|the products you use (including prescription drugs,||
1736|227|P|nonprescription drugs, and herbal products).||
1736|228|P|   Older adults may be more sensitive to the side effects of this||
1736|229|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
1736|230|P|breathing, QT prolongation (see above).||
1736|231|P|   During pregnancy, this medication should be used only when||
1736|232|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1736|233|P|benefits with your doctor. (See also Warning section.)||
1736|234|P|   This drug passes into breast milk and may have undesirable||
1736|235|P|effects on a nursing infant. Tell the doctor right away if your||
1736|236|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1736|237|P|breathing. Consult your doctor before breastfeeding.||
1736|238|B|||
1736|239|I|DRUG INTERACTIONS:  See also Warning section.||
1736|240|I|   Drug interactions may change how your medications work or||
1736|241|I|increase your risk for serious side effects. This document does||
1736|242|I|not contain all possible drug interactions. Keep a list of all||
1736|243|I|the products you use (including prescription/nonprescription||
1736|244|I|drugs and herbal products) and share it with your doctor and||
1736|245|I|pharmacist. Do not start, stop, or change the dosage of any||
1736|246|I|medicines without your doctor's approval.||
1736|247|I|   Some products that may interact with this drug include:||
1736|248|I|certain pain medications (mixed opioid agonist-antagonists such||
1736|249|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
1736|250|I|samidorphan.||
1736|251|I|   The risk of serious side effects (such as slow/shallow||
1736|252|I|breathing, severe drowsiness/dizziness) may be increased if this||
1736|253|I|medication is used with other products that may also cause||
1736|254|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1736|255|I|if you are taking other products such as other opioid pain or||
1736|256|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1736|257|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1736|258|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1736|259|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1736|260|I|cetirizine, diphenhydramine).||
1736|261|I|   Check the labels on all your medicines (such as allergy or||
1736|262|I|cough-and-cold products) because they may contain ingredients||
1736|263|I|that cause drowsiness. Ask your pharmacist about using those||
1736|264|I|products safely.||
1736|265|I|   This medication may interfere with certain lab tests||
1736|266|I|(including amylase/lipase levels), possibly causing false test||
1736|267|I|results. Make sure lab personnel and all your doctors know you||
1736|268|I|use this drug.||
1736|269|B|||
1736|270|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1736|271|O|as passing out or trouble breathing, give them naloxone or||
1736|272|O|nalmefene if available, then call 911. If the person is awake and||
1736|273|O|has no symptoms, call a poison control center right away. US||
1736|274|O|residents can call 1-800-222-1222. Canada residents can call||
1736|275|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1736|276|O|breathing, slow heartbeat, coma.||
1736|277|B|||
1736|278|N|NOTES:  Do not share this medication with others. Sharing it is||
1736|279|N|against the law.||
1736|280|N|   This medication has been prescribed for your current condition||
1736|281|N|only. Do not use it later for another condition unless your||
1736|282|N|doctor directs you to do so. A different medication may be||
1736|283|N|necessary in that case.||
1736|284|B|||
1736|285|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1736|286|D|If it is near the time of the next dose, skip the missed dose.||
1736|287|D|Use your next dose at the regular time. Do not double the dose to||
1736|288|D|catch up.||
1736|289|B|||
1736|290|R|STORAGE:  Store at room temperature away from light and moisture.||
1736|291|R|Do not store in the bathroom. Keep all medications away from||
1736|292|R|children and pets.||
1736|293|R|   Do not flush medications down the toilet or pour them into a||
1736|294|R|drain unless instructed to do so. Properly discard this product||
1736|295|R|when it is expired or no longer needed. For more details, read||
1736|296|R|the Medication Guide, or consult your pharmacist or local waste||
1736|297|R|disposal company.||
1736|298|B|||
1736|299|A|Information last revised August 2025.||
1736|300|A|Copyright(c) 2025 First Databank, Inc.||
1736|301|B|||
1737|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1737|002|Z|does NOT have all possible information about this product. This||
1737|003|Z|information does not assure that this product is safe, effective,||
1737|004|Z|or appropriate for you. This information is not individual||
1737|005|Z|medical advice and does not substitute for the advice of your||
1737|006|Z|health care professional. Always ask your health care||
1737|007|Z|professional for complete information about this product and your||
1737|008|Z|specific health needs.||
1737|009|B|||
1737|010|T|PATIROMER - ORAL||
1737|011|F|(pa-TIR-oh-mer)||
1737|012|B|||
1737|013|C|COMMON BRAND NAME(S): Veltassa||
1737|014|B|||
1737|015|U|USES:  This medication is used to treat a high level of potassium||
1737|016|U|in your blood. Too much potassium in your blood can sometimes||
1737|017|U|cause heart rhythm problems. Patiromer helps get rid of extra||
1737|018|U|potassium by binding to it. The potassium then passes out of your||
1737|019|U|body in your stool.||
1737|020|B|||
1737|021|H|HOW TO USE:  Take this medication by mouth with or without food||
1737|022|H|as directed by your doctor, usually once daily. The dosage is||
1737|023|H|based on your medical condition, potassium lab test results, and||
1737|024|H|response to treatment.||
1737|025|H|   Do not heat patiromer or add it to hot foods or liquids. Mix||
1737|026|H|this medication right before taking it. Open the packet and mix||
1737|027|H|the powder as directed with liquid (such as water, apple juice)||
1737|028|H|or soft food (such as applesauce, pudding, yogurt). If using||
1737|029|H|liquid to mix, the powder does not dissolve so the liquid mixture||
1737|030|H|will look cloudy. If any powder is left in the glass after||
1737|031|H|drinking the mixture, add more liquid, stir, and drink it right||
1737|032|H|away to make sure you take the whole dose. If using food to mix,||
1737|033|H|make sure to eat all of the mixture to make sure you take the||
1737|034|H|whole dose.||
1737|035|H|   Patiromer may decrease your absorption of other medications,||
1737|036|H|which may make them work less well. Ask your pharmacist about the||
1737|037|H|other medications you take. You may need to take patiromer at||
1737|038|H|least 3 hours before or 3 hours after certain medications.||
1737|039|B|||
1737|040|S|SIDE EFFECTS:  Constipation or diarrhea may occur. If either of||
1737|041|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1737|042|S|promptly.||
1737|043|S|   Remember that this medication has been prescribed because your||
1737|044|S|doctor has judged that the benefit to you is greater than the||
1737|045|S|risk of side effects. Many people using this medication do not||
1737|046|S|have serious side effects.||
1737|047|S|   Patiromer may cause a low magnesium blood level. Your doctor||
1737|048|S|will check your level and prescribe a magnesium supplement if||
1737|049|S|your level is low. Tell your doctor right away if you have:||
1737|050|S|symptoms of a low magnesium blood level (such as muscle cramps,||
1737|051|S|irregular heartbeat, mental/mood changes like confusion).||
1737|052|S|   A very serious allergic reaction to this drug is rare.||
1737|053|S|However, get medical help right away if you notice any symptoms||
1737|054|S|of a serious allergic reaction, including: rash, itching/swelling||
1737|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1737|056|S|breathing.||
1737|057|S|   This is not a complete list of possible side effects. If you||
1737|058|S|notice other effects not listed above, contact your doctor or||
1737|059|S|pharmacist.||
1737|060|S|   In the US -||
1737|061|S|   Call your doctor for medical advice about side effects. You||
1737|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1737|063|S|www.fda.gov/medwatch.||
1737|064|S|   In Canada - Call your doctor for medical advice about side||
1737|065|S|effects. You may report side effects to Health Canada at||
1737|066|S|1-866-234-2345.||
1737|067|B|||
1737|068|P|PRECAUTIONS:  Before taking patiromer, tell your doctor or||
1737|069|P|pharmacist if you are allergic to it; or if you have any other||
1737|070|P|allergies. This product may contain inactive ingredients, which||
1737|071|P|can cause allergic reactions or other problems. Talk to your||
1737|072|P|pharmacist for more details.||
1737|073|P|   Before using this medication, tell your doctor or pharmacist||
1737|074|P|your medical history, especially of: problems with your bowel||
1737|075|P|movement (such as severe constipation, intestinal/bowel blockage,||
1737|076|P|dry hard stool/impaction, slowed bowel after stomach/intestinal||
1737|077|P|surgery), low magnesium blood level.||
1737|078|P|   Before having surgery, tell your doctor or dentist about all||
1737|079|P|the products you use (including prescription drugs,||
1737|080|P|nonprescription drugs, and herbal products).||
1737|081|P|   Older adults may be more sensitive to the side effects of this||
1737|082|P|drug, especially constipation or diarrhea.||
1737|083|P|   Tell your doctor if you are pregnant before using this||
1737|084|P|medication.||
1737|085|P|   This medication does not pass into breast milk. Consult your||
1737|086|P|doctor before breastfeeding.||
1737|087|B|||
1737|088|I|DRUG INTERACTIONS:  See also How to Use section.||
1737|089|I|   Drug interactions may change how your medications work or||
1737|090|I|increase your risk for serious side effects. This document does||
1737|091|I|not contain all possible drug interactions. Keep a list of all||
1737|092|I|the products you use (including prescription/nonprescription||
1737|093|I|drugs and herbal products) and share it with your doctor and||
1737|094|I|pharmacist. Do not start, stop, or change the dosage of any||
1737|095|I|medicines without your doctor's approval.||
1737|096|B|||
1737|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1737|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1737|099|O|poison control center right away. US residents can call||
1737|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1737|101|O|Symptoms of overdose may include: muscle cramps, weakness,||
1737|102|O|irregular heartbeat.||
1737|103|B|||
1737|104|N|NOTES:  Do not share this medication with others.||
1737|105|N|   Lab tests (such as magnesium and potassium blood levels) must||
1737|106|N|be done while you are taking this medication. Keep all medical||
1737|107|N|and lab appointments.||
1737|108|N|   If your doctor has prescribed a special diet for you, follow||
1737|109|N|it.||
1737|110|B|||
1737|111|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1737|112|D|remember. If it is near the time of the next dose, skip the||
1737|113|D|missed dose. Take your next dose at the regular time. Do not||
1737|114|D|double the dose to catch up.||
1737|115|B|||
1737|116|R|STORAGE:  Store in the refrigerator. This medication may also be||
1737|117|R|stored at room temperature if needed. If the medication is stored||
1737|118|R|at room temperature, discard after 3 months. Avoid high heat.||
1737|119|R|Keep all medications away from children and pets.||
1737|120|R|   Do not flush medications down the toilet or pour them into a||
1737|121|R|drain unless instructed to do so. Properly discard this product||
1737|122|R|when it is expired or no longer needed. Consult your pharmacist||
1737|123|R|or local waste disposal company.||
1737|124|B|||
1737|125|A|Information last revised September 2024.||
1737|126|A|Copyright(c) 2025 First Databank, Inc.||
1737|127|B|||
1738|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1738|002|Z|does NOT have all possible information about this product. This||
1738|003|Z|information does not assure that this product is safe, effective,||
1738|004|Z|or appropriate for you. This information is not individual||
1738|005|Z|medical advice and does not substitute for the advice of your||
1738|006|Z|health care professional. Always ask your health care||
1738|007|Z|professional for complete information about this product and your||
1738|008|Z|specific health needs.||
1738|009|B|||
1738|010|T|IXAZOMIB - ORAL||
1738|011|F|(ix-AZ-oh-mib)||
1738|012|B|||
1738|013|C|COMMON BRAND NAME(S): Ninlaro||
1738|014|B|||
1738|015|U|USES:  This medication is used to treat a certain type of cancer||
1738|016|U|(multiple myeloma). It works by slowing or stopping the growth of||
1738|017|U|cancer cells.||
1738|018|B|||
1738|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1738|020|H|from your pharmacist before you start taking ixazomib and each||
1738|021|H|time you get a refill. If you have any questions, ask your doctor||
1738|022|H|or pharmacist.||
1738|023|H|   Take this medication by mouth at least 1 hour before or 2||
1738|024|H|hours after food as directed by your doctor, usually once a week||
1738|025|H|for 3 weeks, then stopping the medication for 1 week. This is one||
1738|026|H|cycle of treatment. Keep taking the medication this way as||
1738|027|H|directed by your doctor. Swallow the medication whole with water.||
1738|028|H|Do not crush, chew, or open the capsules.||
1738|029|H|   If you vomit after taking a dose, do not take another dose at||
1738|030|H|that time. Take your next dose at the regular time.||
1738|031|H|   The dosage is based on your medical condition, lab tests, and||
1738|032|H|response to treatment.||
1738|033|H|   Take this medication regularly to get the most benefit from||
1738|034|H|it. To help you remember, take it at the same time and day of the||
1738|035|H|week on the weeks you take the medication.||
1738|036|H|   Do not increase your dose or use this drug more often or for||
1738|037|H|longer than prescribed. Your condition will not improve any||
1738|038|H|faster, and your risk of side effects will increase.||
1738|039|H|   If a capsule breaks, avoid skin and eye contact with the||
1738|040|H|contents of the capsule. If the contents of the capsule get on||
1738|041|H|the skin, wash the area with plenty of water and soap. If the||
1738|042|H|contents of the capsule get in the eyes, flush the eyes with||
1738|043|H|plenty of water.||
1738|044|H|   Since this drug can be absorbed through the skin and may harm||
1738|045|H|an unborn baby, women who are pregnant or who may become pregnant||
1738|046|H|should not handle this medication.||
1738|047|B|||
1738|048|S|SIDE EFFECTS:  Diarrhea, nausea/vomiting, constipation, dry eyes,||
1738|049|S|blurred vision, or eye redness/itching/discharge may occur.||
1738|050|S|Nausea, vomiting, and diarrhea can be severe. In some cases, your||
1738|051|S|doctor may prescribe medication to prevent or relieve nausea,||
1738|052|S|vomiting, and diarrhea. Eating several small meals, not eating||
1738|053|S|before treatment, or limiting activity may help lessen the nausea||
1738|054|S|and vomiting. If any of these effects last or get worse, tell||
1738|055|S|your doctor or pharmacist promptly.||
1738|056|S|   People using this medication may have serious side effects.||
1738|057|S|However, you have been prescribed this drug because your doctor||
1738|058|S|has judged that the benefit to you is greater than the risk of||
1738|059|S|side effects. Careful monitoring by your doctor may decrease your||
1738|060|S|risk.||
1738|061|S|   Tell your doctor right away if you have any serious side||
1738|062|S|effects, including: easy bruising/bleeding, signs of infection||
1738|063|S|(such as sore throat that doesn't go away, fever, chills),||
1738|064|S|shingles skin rash/pain (herpes zoster), numbness/tingling of||
1738|065|S|arms/legs, swelling hands/ankles/feet, sudden/unexplained weight||
1738|066|S|gain, symptoms of liver disease (such as nausea/vomiting that||
1738|067|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
1738|068|S|eyes/skin, dark urine).||
1738|069|S|   This medication can rarely cause serious blood clots and||
1738|070|S|damage to small blood vessels in your body, especially in the||
1738|071|S|kidney and brain. Get medical help right away if you develop||
1738|072|S|symptoms such as unusual tiredness or change in the amount of||
1738|073|S|urine.||
1738|074|S|   Ixazomib can commonly cause a rash that is usually not||
1738|075|S|serious. However, you may not be able to tell it apart from a||
1738|076|S|rare rash that could be a sign of a severe reaction. Get medical||
1738|077|S|help right away if you develop any rash.||
1738|078|S|   A very serious allergic reaction to this drug is rare.||
1738|079|S|However, get medical help right away if you notice any symptoms||
1738|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1738|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1738|082|S|breathing.||
1738|083|S|   This is not a complete list of possible side effects. If you||
1738|084|S|notice any other effects not listed above, contact your doctor or||
1738|085|S|pharmacist.||
1738|086|S|   In the US -||
1738|087|S|   Call your doctor for medical advice about side effects. You||
1738|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1738|089|S|www.fda.gov/medwatch.||
1738|090|S|   In Canada - Call your doctor for medical advice about side||
1738|091|S|effects. You may report side effects to Health Canada at||
1738|092|S|1-866-234-2345.||
1738|093|B|||
1738|094|P|PRECAUTIONS:  Before taking ixazomib, tell your doctor or||
1738|095|P|pharmacist if you are allergic to it; or if you have any other||
1738|096|P|allergies. This product may contain inactive ingredients, which||
1738|097|P|can cause allergic reactions or other problems. Talk to your||
1738|098|P|pharmacist for more details.||
1738|099|P|   Before using this medication, tell your doctor or pharmacist||
1738|100|P|your medical history, especially of: liver disease, kidney||
1738|101|P|disease.||
1738|102|P|   This drug may cause blurred vision. Do not drive, use||
1738|103|P|machinery, or do anything that needs clear vision until you can||
1738|104|P|do it safely. Limit alcoholic beverages.||
1738|105|P|   Before having surgery, tell your doctor or dentist about all||
1738|106|P|the products you use (including prescription drugs,||
1738|107|P|nonprescription drugs, and herbal products).||
1738|108|P|   Since this drug can be absorbed through the skin and may harm||
1738|109|P|an unborn baby, women who are pregnant or who may become pregnant||
1738|110|P|should not handle this medication.||
1738|111|P|   Tell your doctor if you are pregnant or plan to become||
1738|112|P|pregnant. You should not become pregnant while taking ixazomib.||
1738|113|P|Ixazomib may harm an unborn baby. Your doctor should order a||
1738|114|P|pregnancy test before you start this medication. Men and women||
1738|115|P|using this medication should ask about reliable forms of birth||
1738|116|P|control during treatment and for 90 days after the last dose.||
1738|117|P|Women should also ask about using additional reliable forms of||
1738|118|P|non-hormonal birth control (such as condoms, diaphragm with||
1738|119|P|spermicide) if they are using hormonal birth control (such as||
1738|120|P|birth control pills). If you or your partner becomes pregnant,||
1738|121|P|talk to your doctor right away about the risks and benefits of||
1738|122|P|this medication.||
1738|123|P|   It is unknown if this drug passes into breast milk. Because of||
1738|124|P|the possible risk to the infant, breastfeeding is not recommended||
1738|125|P|while using this drug and for 90 days after the last dose.||
1738|126|P|Consult your doctor before breastfeeding.||
1738|127|B|||
1738|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1738|129|I|medications work or increase your risk for serious side effects.||
1738|130|I|This document does not contain all possible drug interactions.||
1738|131|I|Keep a list of all the products you use (including||
1738|132|I|prescription/nonprescription drugs and herbal products) and share||
1738|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
1738|134|I|the dosage of any medicines without your doctor's approval.||
1738|135|I|   Other medications can affect the removal of ixazomib from your||
1738|136|I|body, which may affect how ixazomib works. Examples include||
1738|137|I|rifamycins (such as rifampin), St. John's wort, drugs used to||
1738|138|I|treat seizures (such as carbamazepine, phenytoin), among others.||
1738|139|B|||
1738|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1738|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1738|142|O|poison control center right away. US residents can call||
1738|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1738|144|B|||
1738|145|N|NOTES:  Do not share this medication with others.||
1738|146|N|   Lab and/or medical tests (such as complete blood count,||
1738|147|N|liver/kidney function) should be done before you start taking||
1738|148|N|this medication and while you are taking it. Keep all medical and||
1738|149|N|lab appointments. Consult your doctor for more details.||
1738|150|B|||
1738|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1738|152|D|remember. If it is within 72 hours (3 days) of the next dose,||
1738|153|D|skip the missed dose. Take your next dose at the regular time. Do||
1738|154|D|not double the dose to catch up.||
1738|155|B|||
1738|156|R|STORAGE:  Store in original package at room temperature away from||
1738|157|R|light and moisture. Do not freeze. Do not open packaging until||
1738|158|R|you are ready to use the medication. Do not store in the||
1738|159|R|bathroom. Keep all medications away from children and pets.||
1738|160|R|   Do not flush medications down the toilet or pour them into a||
1738|161|R|drain unless instructed to do so. Properly discard this product||
1738|162|R|when it is expired or no longer needed. Consult your pharmacist||
1738|163|R|or local waste disposal company.||
1738|164|B|||
1738|165|A|Information last revised April 2025.||
1738|166|A|Copyright(c) 2025 First Databank, Inc.||
1738|167|B|||
1739|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1739|002|Z|does NOT have all possible information about this product. This||
1739|003|Z|information does not assure that this product is safe, effective,||
1739|004|Z|or appropriate for you. This information is not individual||
1739|005|Z|medical advice and does not substitute for the advice of your||
1739|006|Z|health care professional. Always ask your health care||
1739|007|Z|professional for complete information about this product and your||
1739|008|Z|specific health needs.||
1739|009|B|||
1739|010|T|NALOXONE SPRAY - NASAL||
1739|011|F|(nal-OX-one)||
1739|012|B|||
1739|013|C|COMMON BRAND NAME(S): Narcan, RiVive||
1739|014|B|||
1739|015|U|USES:  Naloxone is used for the emergency treatment of known or||
1739|016|U|suspected opioid overdose. Serious opioid overdose symptoms may||
1739|017|U|include unusual sleepiness, unusual difficulty waking up, or||
1739|018|U|breathing problems (ranging from slow/shallow breathing to no||
1739|019|U|breathing). Other symptoms of overdose may include very small||
1739|020|U|"pinpoint" pupils, slow heartbeat, or low blood pressure. If||
1739|021|U|someone has serious overdose symptoms but you are not sure if the||
1739|022|U|symptoms are due to opioid overdose, give naloxone right away||
1739|023|U|anyway, since lasting slow/shallow breathing may cause permanent||
1739|024|U|damage to the brain or death. Since symptoms of opioid overdose||
1739|025|U|may return after treatment, be sure to get medical help right||
1739|026|U|away after giving the first dose of naloxone.||
1739|027|U|   This medication belongs to a class of drugs known as opioid||
1739|028|U|antagonists. It works by blocking the effects of the opioid in||
1739|029|U|the brain.||
1739|030|B|||
1739|031|H|HOW TO USE:  If your doctor has prescribed this medication, read||
1739|032|H|the Patient Information Leaflet and Instructions for Use provided||
1739|033|H|by your pharmacist when you get this medication and each time you||
1739|034|H|get a refill. If you are using the over-the-counter product, read||
1739|035|H|and follow all directions on the product package before using||
1739|036|H|this medication. Be sure to keep this medication handy in case it||
1739|037|H|is needed. Learn ahead of time how to properly give this||
1739|038|H|medication. If you have any questions, ask your doctor or||
1739|039|H|pharmacist.||
1739|040|H|   Close family and household members should know the symptoms of||
1739|041|H|an opioid overdose and be instructed on how to give naloxone if||
1739|042|H|needed. Opioid overdose should be treated right away to prevent||
1739|043|H|serious effects (such as brain damage). See also Uses section.||
1739|044|H|   Remove the naloxone spray from the package only when you are||
1739|045|H|ready to use it. Lay the person on their back. Tilt the person's||
1739|046|H|head back and support their neck with your hand. Use your other||
1739|047|H|hand to gently insert the tip of the spray nozzle into one||
1739|048|H|nostril, then firmly press the plunger to give the dose. Some||
1739|049|H|brands may direct you to move the person onto their side after||
1739|050|H|removing the spray nozzle from the nostril. Follow the directions||
1739|051|H|for your brand carefully.||
1739|052|H|   The effects of this medication are rapid but not long lasting.||
1739|053|H|After giving naloxone, get medical help right away, even if the||
1739|054|H|person wakes up. If symptoms return after giving the spray, give||
1739|055|H|another dose in the other nostril every 2 to 3 minutes, changing||
1739|056|H|nostrils with each dose. Each spray contains only one dose and||
1739|057|H|cannot be reused. Continue to closely watch the person until||
1739|058|H|emergency help comes. Tell the health care professional that you||
1739|059|H|have given naloxone spray.||
1739|060|B|||
1739|061|S|SIDE EFFECTS:  Nasal dryness, swelling, or stuffy nose may occur.||
1739|062|S|Muscle/joint pain or headache may also occur. If any of these||
1739|063|S|effects last or get worse, tell your doctor or pharmacist||
1739|064|S|promptly.||
1739|065|S|   If your doctor has directed you to use this product, remember||
1739|066|S|that your doctor has judged that the benefit to you is greater||
1739|067|S|than the risk of side effects. Many people using this medication||
1739|068|S|do not have serious side effects.||
1739|069|S|   In someone who has been using an opioid regularly, withdrawal||
1739|070|S|symptoms can happen suddenly after receiving this medication.||
1739|071|S|Withdrawal symptoms may include body aches, fever, sweating,||
1739|072|S|watering eyes, runny nose, sneezing, goose bumps, yawning,||
1739|073|S|weakness, shivering/trembling, nervousness, restlessness,||
1739|074|S|diarrhea, nausea/vomiting, stomach cramps, increased blood||
1739|075|S|pressure, fast heartbeat. In babies younger than 4 weeks who have||
1739|076|S|been receiving an opioid regularly, sudden opioid withdrawal may||
1739|077|S|be life threatening if not treated the right way. Symptoms in||
1739|078|S|babies may include seizures, crying more than usual, and muscle||
1739|079|S|twitching/spasms.||
1739|080|S|   A very serious allergic reaction to this drug is rare.||
1739|081|S|However, get medical help right away if you notice any symptoms||
1739|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1739|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1739|084|S|breathing.||
1739|085|S|   This is not a complete list of possible side effects. If you||
1739|086|S|notice other effects not listed above, contact your doctor or||
1739|087|S|pharmacist.||
1739|088|S|   In the US -||
1739|089|S|   Call your doctor for medical advice about side effects. You||
1739|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1739|091|S|www.fda.gov/medwatch.||
1739|092|S|   In Canada - Call your doctor for medical advice about side||
1739|093|S|effects. You may report side effects to Health Canada at||
1739|094|S|1-866-234-2345.||
1739|095|B|||
1739|096|P|PRECAUTIONS:  Before using naloxone, tell your doctor or||
1739|097|P|pharmacist if you are allergic to it; or if you have any other||
1739|098|P|allergies. This product may contain inactive ingredients, which||
1739|099|P|can cause allergic reactions or other problems. Talk to your||
1739|100|P|pharmacist for more details.||
1739|101|P|   Before using this medication, tell your doctor or pharmacist||
1739|102|P|your medical history, especially of: heart problems (such as||
1739|103|P|irregular heartbeat, previous heart attack).||
1739|104|P|   Before having surgery, tell your doctor or dentist about all||
1739|105|P|the products you use (including prescription drugs,||
1739|106|P|nonprescription drugs, and herbal products).||
1739|107|P|   Since untreated opioid overdose can harm both a pregnant woman||
1739|108|P|and her unborn baby, this medication may be used during||
1739|109|P|pregnancy. However, naloxone may cause opioid withdrawal in your||
1739|110|P|unborn baby. Tell your doctor right away that you used this||
1739|111|P|medication, so you and your unborn baby can be monitored. Ask||
1739|112|P|your doctor for details.||
1739|113|P|   It is unknown if this medication passes into breast milk.||
1739|114|P|However, it is unlikely to harm a nursing infant. Consult your||
1739|115|P|doctor before breastfeeding.||
1739|116|B|||
1739|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1739|118|I|medications work or increase your risk for serious side effects.||
1739|119|I|This document does not contain all possible drug interactions.||
1739|120|I|Keep a list of all the products you use (including||
1739|121|I|prescription/nonprescription drugs and herbal products) and share||
1739|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
1739|123|I|the dosage of any medicines without your doctor's approval.||
1739|124|B|||
1739|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1739|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1739|127|O|poison control center right away. US residents can call||
1739|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1739|129|B|||
1739|130|N|NOTES:  Ask your doctor or pharmacist about ways to prevent||
1739|131|N|opioid overdose. Teach your close family or household members the||
1739|132|N|signs and symptoms of an opioid overdose and tell them where you||
1739|133|N|keep this medication.||
1739|134|B|||
1739|135|D|MISSED DOSE:  Not applicable.||
1739|136|B|||
1739|137|R|STORAGE:  Different brands of this medication have different||
1739|138|R|storage needs. Check the product package for instructions on how||
1739|139|R|to store your brand, or ask your pharmacist. From time to time,||
1739|140|R|check the expiration date and replace the medication before it||
1739|141|R|expires. Keep all medications away from children and pets.||
1739|142|R|   Do not flush medications down the toilet or pour them into a||
1739|143|R|drain unless instructed to do so. Properly discard this||
1739|144|R|medication when it is expired or no longer needed. Consult your||
1739|145|R|pharmacist or local waste disposal company.||
1739|146|B|||
1739|147|A|Information last revised September 2025.||
1739|148|A|Copyright(c) 2025 First Databank, Inc.||
1739|149|B|||
1740|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1740|002|Z|does NOT have all possible information about this product. This||
1740|003|Z|information does not assure that this product is safe, effective,||
1740|004|Z|or appropriate for you. This information is not individual||
1740|005|Z|medical advice and does not substitute for the advice of your||
1740|006|Z|health care professional. Always ask your health care||
1740|007|Z|professional for complete information about this product and your||
1740|008|Z|specific health needs.||
1740|009|B|||
1740|010|T|ELOTUZUMAB - INJECTION||
1740|011|F|(EL-oh-TOOZ-ue-mab)||
1740|012|B|||
1740|013|C|COMMON BRAND NAME(S): Empliciti||
1740|014|B|||
1740|015|U|USES:  This medication is used to treat a certain type of cancer||
1740|016|U|(multiple myeloma). Elotuzumab belongs to a class of drugs known||
1740|017|U|as monoclonal antibodies. It works by slowing or stopping the||
1740|018|U|growth of cancer cells.||
1740|019|B|||
1740|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1740|021|H|from your pharmacist before you start using elotuzumab and each||
1740|022|H|time you receive the medication. If you have any questions, ask||
1740|023|H|your doctor or pharmacist.||
1740|024|H|   This medication is given by injection into a vein by a health||
1740|025|H|care professional. It is given as directed by your doctor,||
1740|026|H|usually once a week for the first 8 weeks. After that it is||
1740|027|H|usually given once every 2 or 4 weeks. The dosage is based on||
1740|028|H|your weight and other medications you are taking.||
1740|029|H|   Infusion reactions may happen during the infusion of this||
1740|030|H|drug. Your doctor may prescribe other medications before each||
1740|031|H|treatment to help prevent these side effects. Tell your doctor||
1740|032|H|right away if you have any symptoms of infusion reactions such as||
1740|033|H|fever, chills, dizziness, chest discomfort, or slow heartbeat.||
1740|034|B|||
1740|035|S|SIDE EFFECTS:  See also How to Use section.||
1740|036|S|   Loss of appetite, weight loss, diarrhea, constipation,||
1740|037|S|headache, or tiredness may occur. If any of these effects last or||
1740|038|S|get worse, tell your doctor or pharmacist promptly.||
1740|039|S|   Remember that this medication has been prescribed because your||
1740|040|S|doctor has judged that the benefit to you is greater than the||
1740|041|S|risk of side effects. Many people using this medication do not||
1740|042|S|have serious side effects.||
1740|043|S|   Tell your doctor right away if you have any serious side||
1740|044|S|effects, including: signs of liver disease (such as||
1740|045|S|nausea/vomiting that doesn't stop, loss of appetite,||
1740|046|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1740|047|S|numbness/tingling of arms/legs, easy bruising/bleeding, fainting,||
1740|048|S|fast/irregular heartbeat, mental/mood changes, muscle||
1740|049|S|spasms/weakness, unusual tiredness, increased thirst/urination.||
1740|050|S|   This medication may lower your ability to fight infections.||
1740|051|S|This may make you more likely to get a serious (rarely fatal)||
1740|052|S|infection or make any infection you have worse. Tell your doctor||
1740|053|S|right away if you have any signs of infection (such as sore||
1740|054|S|throat that doesn't go away, fever, chills).||
1740|055|S|   People who are treated with this medication may rarely get||
1740|056|S|other cancers (such as skin cancer). Consult your doctor for more||
1740|057|S|details.||
1740|058|S|   A very serious allergic reaction to this drug is rare.||
1740|059|S|However, get medical help right away if you notice any symptoms||
1740|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1740|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1740|062|S|breathing.||
1740|063|S|   This is not a complete list of possible side effects. If you||
1740|064|S|notice other effects not listed above, contact your doctor or||
1740|065|S|pharmacist.||
1740|066|S|   In the US -||
1740|067|S|   Call your doctor for medical advice about side effects. You||
1740|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1740|069|S|www.fda.gov/medwatch.||
1740|070|S|   In Canada - Call your doctor for medical advice about side||
1740|071|S|effects. You may report side effects to Health Canada at||
1740|072|S|1-866-234-2345.||
1740|073|B|||
1740|074|P|PRECAUTIONS:  Before using elotuzumab, tell your doctor or||
1740|075|P|pharmacist if you are allergic to it; or if you have any other||
1740|076|P|allergies. This product may contain inactive ingredients, which||
1740|077|P|can cause allergic reactions or other problems. Talk to your||
1740|078|P|pharmacist for more details.||
1740|079|P|   Before using this medication, tell your doctor or pharmacist||
1740|080|P|your medical history, especially of: liver disease,||
1740|081|P|current/recent infection.||
1740|082|P|   Before having surgery, tell your doctor or dentist about all||
1740|083|P|the products you use (including prescription drugs,||
1740|084|P|nonprescription drugs, and herbal products).||
1740|085|P|   Elotuzumab can make you more likely to get infections or may||
1740|086|P|make current infections worse. Stay away from anyone who has an||
1740|087|P|infection that may easily spread (such as chickenpox, COVID-19,||
1740|088|P|measles, flu). Talk to your doctor if you have been exposed to an||
1740|089|P|infection or for more details.||
1740|090|P|   Tell your health care professional that you are using||
1740|091|P|elotuzumab before having any immunizations/vaccinations. Avoid||
1740|092|P|contact with people who have recently received live vaccines||
1740|093|P|(such as flu vaccine inhaled through the nose).||
1740|094|P|   To lower the chance of getting cut, bruised, or injured, use||
1740|095|P|caution with sharp objects like razors and nail cutters, and||
1740|096|P|avoid activities such as contact sports.||
1740|097|P|   Elotuzumab, when used in combination with lenalidomide or||
1740|098|P|pomalidomide, must not be used during pregnancy. The combination||
1740|099|P|may cause harm (possibly death) to an unborn baby. Two reliable||
1740|100|P|forms of birth control (such as condoms, birth control pills)||
1740|101|P|must be used whenever at least one sexual partner is using these||
1740|102|P|medicines together. Males using these medications must always use||
1740|103|P|a condom during sexual activity. If you or your partner become||
1740|104|P|pregnant, or if you think you or your partner may be pregnant,||
1740|105|P|tell your doctor right away.||
1740|106|P|   It is unknown if this drug passes into breast milk. Because of||
1740|107|P|the possible risk to the infant, breastfeeding is not recommended||
1740|108|P|while using this drug and lenalidomide or pomalidomide. Consult||
1740|109|P|your doctor before breastfeeding.||
1740|110|B|||
1740|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1740|112|I|medications work or increase your risk for serious side effects.||
1740|113|I|This document does not contain all possible drug interactions.||
1740|114|I|Keep a list of all the products you use (including||
1740|115|I|prescription/nonprescription drugs and herbal products) and share||
1740|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1740|117|I|the dosage of any medicines without your doctor's approval.||
1740|118|B|||
1740|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1740|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1740|121|O|poison control center right away. US residents can call||
1740|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1740|123|B|||
1740|124|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
1740|125|N|complete blood count, blood mineral levels, blood pressure, heart||
1740|126|N|rate) should be done while you are using this medication. Keep||
1740|127|N|all medical and lab appointments. Consult your doctor for more||
1740|128|N|details.||
1740|129|B|||
1740|130|D|MISSED DOSE:  It is important to get each dose of this medication||
1740|131|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1740|132|D|right away for a new dosing schedule.||
1740|133|B|||
1740|134|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1740|135|R|doctor's office and will not be stored at home.||
1740|136|R|   Do not flush medications down the toilet or pour them into a||
1740|137|R|drain unless instructed to do so. Properly discard this product||
1740|138|R|when it is expired or no longer needed. Consult your pharmacist||
1740|139|R|or local waste disposal company.||
1740|140|B|||
1740|141|M|MEDICAL ALERT:  Your condition can cause complications in a||
1740|142|M|medical emergency. For information about enrolling in MedicAlert,||
1740|143|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1740|144|B|||
1740|145|A|Information last revised April 2025.||
1740|146|A|Copyright(c) 2025 First Databank, Inc.||
1740|147|B|||
1741|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1741|002|Z|does NOT have all possible information about this product. This||
1741|003|Z|information does not assure that this product is safe, effective,||
1741|004|Z|or appropriate for you. This information is not individual||
1741|005|Z|medical advice and does not substitute for the advice of your||
1741|006|Z|health care professional. Always ask your health care||
1741|007|Z|professional for complete information about this product and your||
1741|008|Z|specific health needs.||
1741|009|B|||
1741|010|T|ALECTINIB - ORAL||
1741|011|F|(al-EK-ti-nib)||
1741|012|B|||
1741|013|C|COMMON BRAND NAME(S): Alecensa||
1741|014|B|||
1741|015|U|USES:  Alectinib is used to treat a certain type of lung cancer.||
1741|016|U|It works by slowing or stopping the growth of cancer cells.||
1741|017|U|Alectinib belongs to a class of drugs known as tyrosine kinase||
1741|018|U|inhibitors.||
1741|019|B|||
1741|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1741|021|H|from your pharmacist before you start taking alectinib and each||
1741|022|H|time you get a refill. If you have any questions, ask your doctor||
1741|023|H|or pharmacist.||
1741|024|H|   Take this medication by mouth with food as directed by your||
1741|025|H|doctor, usually twice daily. Swallow the capsules whole. Do not||
1741|026|H|open or dissolve the contents of the capsules. If you vomit after||
1741|027|H|taking a dose, do not take an extra dose. Take your next dose at||
1741|028|H|the regular time.||
1741|029|H|   The dosage is based on your medical condition, side effects,||
1741|030|H|lab test results, and response to treatment. Do not increase your||
1741|031|H|dose or take this drug more often or for longer than prescribed.||
1741|032|H|Your condition will not improve any faster, and your risk of||
1741|033|H|serious side effects will increase.||
1741|034|H|   Use this medication regularly to get the most benefit from it.||
1741|035|H|To help you remember, take it at the same times each day.||
1741|036|B|||
1741|037|S|SIDE EFFECTS:  Tiredness, constipation, nausea, vomiting,||
1741|038|S|diarrhea, swelling ankles/feet/hands, back pain, headache, weight||
1741|039|S|gain, or vision changes (such as blurred vision, decreased||
1741|040|S|vision) may occur. If any of these effects last or get worse,||
1741|041|S|tell your doctor or pharmacist promptly.||
1741|042|S|   Remember that this medication has been prescribed because your||
1741|043|S|doctor has judged that the benefit to you is greater than the||
1741|044|S|risk of side effects. Many people using this medication do not||
1741|045|S|have serious side effects.||
1741|046|S|   Tell your doctor right away if you have any serious side||
1741|047|S|effects, including: signs of liver problems (such as||
1741|048|S|nausea/vomiting that doesn't stop, loss of appetite,||
1741|049|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), slow||
1741|050|S|heartbeat, dizziness, lightheadedness, fainting, unexplained||
1741|051|S|muscle pain/tenderness/weakness, signs of kidney problems (such||
1741|052|S|as change in the amount of urine).||
1741|053|S|   Get medical help right away if you have any very serious side||
1741|054|S|effects, including: new/worsening lung disease (such as trouble||
1741|055|S|breathing, shortness of breath, cough, fever), chest pain, sudden||
1741|056|S|severe bleeding, black/bloody stools, vomit that contains blood||
1741|057|S|or looks like coffee grounds.||
1741|058|S|   A very serious allergic reaction to this drug is rare.||
1741|059|S|However, get medical help right away if you notice any symptoms||
1741|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1741|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1741|062|S|breathing.||
1741|063|S|   This is not a complete list of possible side effects. If you||
1741|064|S|notice other effects not listed above, contact your doctor or||
1741|065|S|pharmacist.||
1741|066|S|   In the US -||
1741|067|S|   Call your doctor for medical advice about side effects. You||
1741|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1741|069|S|www.fda.gov/medwatch.||
1741|070|S|   In Canada - Call your doctor for medical advice about side||
1741|071|S|effects. You may report side effects to Health Canada at||
1741|072|S|1-866-234-2345.||
1741|073|B|||
1741|074|P|PRECAUTIONS:  Before taking alectinib, tell your doctor or||
1741|075|P|pharmacist if you are allergic to it or if you have any other||
1741|076|P|allergies. This product may contain inactive ingredients, which||
1741|077|P|can cause allergic reactions or other problems. Talk to your||
1741|078|P|pharmacist for more details.||
1741|079|P|   Before using this medication, tell your doctor or pharmacist||
1741|080|P|your medical history, especially of: liver disease, slow||
1741|081|P|heartbeat, kidney disease.||
1741|082|P|   This drug may make you dizzy or cause vision changes. Alcohol||
1741|083|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
1741|084|P|use machinery, or do anything that needs alertness or clear||
1741|085|P|vision until you can do it safely. Limit alcoholic beverages.||
1741|086|P|Talk to your doctor if you are using marijuana (cannabis).||
1741|087|P|   This medication may make you more sensitive to the sun. Limit||
1741|088|P|your time in the sun. Avoid tanning booths and sunlamps during||
1741|089|P|treatment and for at least 1 week after stopping this medication.||
1741|090|P|Use sunscreen and wear protective clothing when outdoors. Tell||
1741|091|P|your doctor right away if you get sunburned or have skin||
1741|092|P|blisters/redness.||
1741|093|P|   Before having surgery, tell your doctor or dentist about all||
1741|094|P|the products you use (including prescription drugs,||
1741|095|P|nonprescription drugs, and herbal products).||
1741|096|P|   Tell your doctor if you are pregnant or plan to become||
1741|097|P|pregnant. You should not become pregnant while using alectinib.||
1741|098|P|Alectinib may harm an unborn baby. Your doctor should order a||
1741|099|P|pregnancy test before you start this medication. Women using this||
1741|100|P|medication should ask about reliable forms of birth control||
1741|101|P|during treatment and for some time after the last dose. Men using||
1741|102|P|this medication should ask about reliable forms of birth control||
1741|103|P|during treatment and for 3 months after the last dose. If you or||
1741|104|P|your partner becomes pregnant, talk to your doctor right away||
1741|105|P|about the risks and benefits of this medication.||
1741|106|P|   It is unknown if this medication passes into breast milk.||
1741|107|P|Because of the possible risk to the infant, breastfeeding is not||
1741|108|P|recommended while using this medication and for 1 week after the||
1741|109|P|last dose. Consult your doctor before breastfeeding.||
1741|110|B|||
1741|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1741|112|I|medications work or increase your risk for serious side effects.||
1741|113|I|This document does not contain all possible drug interactions.||
1741|114|I|Keep a list of all the products you use (including||
1741|115|I|prescription/nonprescription drugs and herbal products) and share||
1741|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1741|117|I|the dosage of any medicines without your doctor's approval.||
1741|118|B|||
1741|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1741|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1741|121|O|poison control center right away. US residents can call||
1741|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1741|123|B|||
1741|124|N|NOTES:  Do not share this medication with others.||
1741|125|N|   Lab and/or medical tests (such as kidney/liver function, heart||
1741|126|N|rate, blood pressure, CPK levels) should be done while you are||
1741|127|N|taking this medication. Keep all medical and lab appointments.||
1741|128|B|||
1741|129|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1741|130|D|next dose at the regular time. Do not double the dose to catch||
1741|131|D|up.||
1741|132|B|||
1741|133|R|STORAGE:  Store in the original container at room temperature||
1741|134|R|away from light and moisture. Do not store in the bathroom. Keep||
1741|135|R|all medications away from children and pets.||
1741|136|R|   Do not flush medications down the toilet or pour them into a||
1741|137|R|drain unless instructed to do so. Properly discard this product||
1741|138|R|when it is expired or no longer needed. Consult your pharmacist||
1741|139|R|or local waste disposal company.||
1741|140|B|||
1741|141|A|Information last revised June 2025.||
1741|142|A|Copyright(c) 2025 First Databank, Inc.||
1741|143|B|||
1742|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1742|002|Z|does NOT have all possible information about this product. This||
1742|003|Z|information does not assure that this product is safe, effective,||
1742|004|Z|or appropriate for you. This information is not individual||
1742|005|Z|medical advice and does not substitute for the advice of your||
1742|006|Z|health care professional. Always ask your health care||
1742|007|Z|professional for complete information about this product and your||
1742|008|Z|specific health needs.||
1742|009|B|||
1742|010|T|FACTOR X, HUMAN - INJECTION||
1742|011|F|(FAK-tor)||
1742|012|B|||
1742|013|C|COMMON BRAND NAME(S): Coagadex||
1742|014|B|||
1742|015|U|USES:  This medication is used to prevent or control bleeding in||
1742|016|U|people with little or no factor X, a condition also known as||
1742|017|U|Stuart-Prower deficiency. This condition may occur due to being||
1742|018|U|passed down through families (inherited). It may also be caused||
1742|019|U|by a lack of vitamin K or by certain medical conditions (such as||
1742|020|U|amyloidosis, liver disease). Factor X is a clotting factor in the||
1742|021|U|blood that helps bleeding stop normally. People with little or no||
1742|022|U|factor X are at risk for easy bruising, nose or mouth bleeds,||
1742|023|U|heavy menstrual periods (women), bleeding longer after an||
1742|024|U|injury/surgery, or sudden bleeding (such as in the joints,||
1742|025|U|muscles, head, stomach/gut) without a clear cause.||
1742|026|B|||
1742|027|H|HOW TO USE:  Read the Patient Information Leaflet and||
1742|028|H|Instructions for Use if available from your pharmacist before you||
1742|029|H|start using factor X and each time you get a refill. If you have||
1742|030|H|any questions, ask your doctor or pharmacist.||
1742|031|H|   This medication is given by injection into a vein as directed||
1742|032|H|by your doctor. The dosage is based on your medical condition||
1742|033|H|(such as the amount and location of bleeding), weight, lab tests,||
1742|034|H|and response to treatment.||
1742|035|H|   If you are using this medication at home, learn all||
1742|036|H|preparation and usage instructions from the manufacturer and your||
1742|037|H|health care professional. Learn how to store and discard medical||
1742|038|H|supplies safely.||
1742|039|H|   Tell your doctor if your condition (bleeding) lasts or gets||
1742|040|H|worse.||
1742|041|B|||
1742|042|S|SIDE EFFECTS:  Redness or pain at the injection site, tiredness,||
1742|043|S|or back pain may occur. If any of these effects last or get||
1742|044|S|worse, tell your doctor or pharmacist promptly.||
1742|045|S|   Remember that this medication has been prescribed because your||
1742|046|S|doctor has judged that the benefit to you is greater than the||
1742|047|S|risk of side effects. Many people using this medication do not||
1742|048|S|have serious side effects.||
1742|049|S|   A very serious allergic reaction to this drug is rare.||
1742|050|S|However, get medical help right away if you notice any symptoms||
1742|051|S|of a serious allergic reaction, including: rash, itching/swelling||
1742|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1742|053|S|breathing.||
1742|054|S|   This is not a complete list of possible side effects. If you||
1742|055|S|notice other effects not listed above, contact your doctor or||
1742|056|S|pharmacist.||
1742|057|S|   In the US -||
1742|058|S|   Call your doctor for medical advice about side effects. You||
1742|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1742|060|S|www.fda.gov/medwatch.||
1742|061|S|   In Canada - Call your doctor for medical advice about side||
1742|062|S|effects. You may report side effects to Health Canada at||
1742|063|S|1-866-234-2345.||
1742|064|B|||
1742|065|P|PRECAUTIONS:  Before using factor X, tell your doctor or||
1742|066|P|pharmacist if you are allergic to it; or if you have any other||
1742|067|P|allergies. This product may contain inactive ingredients, which||
1742|068|P|can cause allergic reactions or other problems. Talk to your||
1742|069|P|pharmacist for more details.||
1742|070|P|   Before using this medication, tell your doctor or pharmacist||
1742|071|P|your medical history, especially of: other bleeding/clotting||
1742|072|P|disorders (such as hemophilia, disseminated intravascular||
1742|073|P|coagulation-DIC).||
1742|074|P|   This medication is made from human blood. Even though the||
1742|075|P|blood is carefully tested, and this medication goes through a||
1742|076|P|special manufacturing process, there is an extremely small chance||
1742|077|P|that you may get infections from the medication (for example,||
1742|078|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
1742|079|P|more information.||
1742|080|P|   Before having surgery, tell your doctor or dentist about all||
1742|081|P|the products you use (including prescription drugs,||
1742|082|P|nonprescription drugs, and herbal products).||
1742|083|P|   During pregnancy, this medication should be used only when||
1742|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
1742|085|P|   It is unknown if this medication passes into breast milk.||
1742|086|P|Consult your doctor before breastfeeding.||
1742|087|B|||
1742|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1742|089|I|medications work or increase your risk for serious side effects.||
1742|090|I|This document does not contain all possible drug interactions.||
1742|091|I|Keep a list of all the products you use (including||
1742|092|I|prescription/nonprescription drugs and herbal products) and share||
1742|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
1742|094|I|the dosage of any medicines without your doctor's approval.||
1742|095|B|||
1742|096|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1742|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1742|098|O|poison control center right away. US residents can call||
1742|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1742|100|B|||
1742|101|N|NOTES:  Do not share this medication with others.||
1742|102|N|   Lab and/or medical tests (such as factor X activity, factor X||
1742|103|N|inhibitor tests) may be done while you are using this medication.||
1742|104|N|Keep all medical and lab appointments.||
1742|105|B|||
1742|106|D|MISSED DOSE:  It is important to get each dose of this medication||
1742|107|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1742|108|D|right away for a new dosing schedule. Do not double the dose to||
1742|109|D|catch up.||
1742|110|B|||
1742|111|R|STORAGE:  Store in the refrigerator or at room temperature. Do||
1742|112|R|not freeze. Keep the medication in the original package to||
1742|113|R|protect from light. Keep all medications away from children and||
1742|114|R|pets.||
1742|115|R|   After mixing, use or discard within 1 hour.||
1742|116|R|   Do not flush medications down the toilet or pour them into a||
1742|117|R|drain unless instructed to do so. Properly discard this product||
1742|118|R|when it is expired or no longer needed. Consult your pharmacist||
1742|119|R|or local waste disposal company.||
1742|120|B|||
1742|121|M|MEDICAL ALERT:  Your condition can cause complications in a||
1742|122|M|medical emergency. For information about enrolling in MedicAlert,||
1742|123|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1742|124|B|||
1742|125|A|Information last revised July 2024.||
1742|126|A|Copyright(c) 2025 First Databank, Inc.||
1742|127|B|||
1743|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1743|002|Z|does NOT have all possible information about this product. This||
1743|003|Z|information does not assure that this product is safe, effective,||
1743|004|Z|or appropriate for you. This information is not individual||
1743|005|Z|medical advice and does not substitute for the advice of your||
1743|006|Z|health care professional. Always ask your health care||
1743|007|Z|professional for complete information about this product and your||
1743|008|Z|specific health needs.||
1743|009|B|||
1743|010|T|NECITUMUMAB - INJECTION||
1743|011|F|(NE-si-TOOM-oo-mab)||
1743|012|B|||
1743|013|C|COMMON BRAND NAME(S): Portrazza||
1743|014|B|||
1743|015|W|WARNING:  Rarely, heart problems (cardiopulmonary arrest) or||
1743|016|W|sudden death have occurred in people treated with necitumumab.||
1743|017|W|Before starting treatment with this medication, tell your doctor||
1743|018|W|if you have a history of heart disease (such as heart failure,||
1743|019|W|irregular heartbeat, previous heart attack). Get medical help||
1743|020|W|right away if you develop chest/jaw/left arm pain, shortness of||
1743|021|W|breath, or unusual sweating. Your doctor will order certain blood||
1743|022|W|tests (such as magnesium, calcium, and potassium) during and||
1743|023|W|after your treatment to monitor and help decrease your risk for||
1743|024|W|heart problems.||
1743|025|B|||
1743|026|U|USES:  This medication is used to treat lung cancer. Necitumumab||
1743|027|U|belongs to a class of drugs known as monoclonal antibodies. It||
1743|028|U|works by changing the action of your own immune system, directing||
1743|029|U|it to attack cancer cells. This effect helps slow or stop the||
1743|030|U|growth of cancer cells.||
1743|031|B|||
1743|032|H|HOW TO USE:  This medication is given by a health care||
1743|033|H|professional. It is injected slowly into a vein as directed by||
1743|034|H|your doctor, usually over at least 60 minutes.||
1743|035|H|   The dosage is based on your medical condition and response to||
1743|036|H|treatment. To get the most benefit, do not miss any doses. To||
1743|037|H|help you remember, mark your calendar with a reminder.||
1743|038|H|   Infusion reactions may happen during the infusion of this||
1743|039|H|drug. Your doctor may prescribe other medications (such as||
1743|040|H|acetaminophen, diphenhydramine) before each treatment to help||
1743|041|H|prevent these side effects. Tell your doctor right away if you||
1743|042|H|have any symptoms of infusion reactions such as chills, fever, or||
1743|043|H|shortness of breath.||
1743|044|B|||
1743|045|S|SIDE EFFECTS:  See also How to Use section.||
1743|046|S|   Skin dryness/itching, headache, upset stomach, weight loss,||
1743|047|S|nausea, vomiting, or diarrhea may occur. Nausea and vomiting can||
1743|048|S|be severe. In some cases, your doctor may prescribe medication to||
1743|049|S|prevent or relieve nausea and vomiting. Eating several small||
1743|050|S|meals, not eating before treatment, or limiting activity may help||
1743|051|S|lessen some of these effects. If any of these effects last or get||
1743|052|S|worse, tell your doctor or pharmacist promptly.||
1743|053|S|   People using this medication may have serious side effects.||
1743|054|S|However, you have been prescribed this drug because your doctor||
1743|055|S|has judged that the benefit to you is greater than the risk of||
1743|056|S|side effects. Careful monitoring by your doctor may decrease your||
1743|057|S|risk.||
1743|058|S|   Tell your doctor right away if you have any serious side||
1743|059|S|effects, including: muscle spasms, trouble swallowing.||
1743|060|S|   Necitumumab can commonly cause skin reactions, such as rash,||
1743|061|S|acne, or redness/swelling/pain of skin around your nails. If the||
1743|062|S|reaction is severe, your doctor may stop or change your treatment||
1743|063|S|schedule or dose of necitumumab. Tell your doctor right away if||
1743|064|S|you develop any skin reactions.||
1743|065|S|   This medication may rarely cause serious problems from blood||
1743|066|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1743|067|S|legs). You may be at increased risk for blood clots if you have a||
1743|068|S|history of blood clots, heart/blood vessel disease, stroke, or if||
1743|069|S|you are immobile (such as on very long plane flights or being||
1743|070|S|bedridden). If you use estrogen-containing products, these may||
1743|071|S|also increase your risk. Before using this medication, if you||
1743|072|S|have any of these conditions report them to your doctor or||
1743|073|S|pharmacist. Get medical help right away if any of these side||
1743|074|S|effects occur: shortness of breath/rapid breathing,||
1743|075|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1743|076|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1743|077|S|sudden/severe headaches, trouble speaking, weakness on one side||
1743|078|S|of the body, sudden vision changes.||
1743|079|S|   A very serious allergic reaction to this drug is rare.||
1743|080|S|However, get medical help right away if you notice any symptoms||
1743|081|S|of a serious allergic reaction, including: rash, itching/swelling||
1743|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1743|083|S|breathing.||
1743|084|S|   This is not a complete list of possible side effects. If you||
1743|085|S|notice other effects not listed above, contact your doctor or||
1743|086|S|pharmacist.||
1743|087|S|   In the US -||
1743|088|S|   Call your doctor for medical advice about side effects. You||
1743|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1743|090|S|www.fda.gov/medwatch.||
1743|091|S|   In Canada - Call your doctor for medical advice about side||
1743|092|S|effects. You may report side effects to Health Canada at||
1743|093|S|1-866-234-2345.||
1743|094|B|||
1743|095|P|PRECAUTIONS:  Before using necitumumab, tell your doctor or||
1743|096|P|pharmacist if you are allergic to it; or if you have any other||
1743|097|P|allergies. This product may contain inactive ingredients, which||
1743|098|P|can cause allergic reactions or other problems. Talk to your||
1743|099|P|pharmacist for more details.||
1743|100|P|   Before using this medication, tell your doctor or pharmacist||
1743|101|P|your medical history, especially of: blood clots (such as in the||
1743|102|P|legs, lungs), high blood pressure, heart disease, stroke.||
1743|103|P|   This medication may make you more sensitive to the sun. Limit||
1743|104|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1743|105|P|sunscreen and wear protective clothing when outdoors. Tell your||
1743|106|P|doctor right away if you get sunburned or have skin||
1743|107|P|blisters/redness.||
1743|108|P|   Before having surgery, tell your doctor or dentist about all||
1743|109|P|the products you use (including prescription drugs,||
1743|110|P|nonprescription drugs, and herbal products).||
1743|111|P|   Tell your doctor if you are pregnant or plan to become||
1743|112|P|pregnant. You should not become pregnant while using necitumumab.||
1743|113|P|Necitumumab may harm an unborn baby. Ask about reliable forms of||
1743|114|P|birth control while using this medication and for at least 3||
1743|115|P|months after the last dose. If you become pregnant, talk to your||
1743|116|P|doctor right away about the risks and benefits of this||
1743|117|P|medication.||
1743|118|P|   It is unknown if this drug passes into breast milk. Because of||
1743|119|P|the possible risk to the infant, breastfeeding is not recommended||
1743|120|P|while using this drug and for 3 months after the last dose.||
1743|121|P|Consult your doctor before breastfeeding.||
1743|122|B|||
1743|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1743|124|I|medications work or increase your risk for serious side effects.||
1743|125|I|This document does not contain all possible drug interactions.||
1743|126|I|Keep a list of all the products you use (including||
1743|127|I|prescription/nonprescription drugs and herbal products) and share||
1743|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
1743|129|I|the dosage of any medicines without your doctor's approval.||
1743|130|B|||
1743|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1743|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1743|133|O|poison control center right away. US residents can call||
1743|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1743|135|B|||
1743|136|N|NOTES:  Lab and/or medical tests (such as calcium, magnesium,||
1743|137|N|potassium levels) should be done while you are using this||
1743|138|N|medication. Keep all medical and lab appointments.||
1743|139|B|||
1743|140|D|MISSED DOSE:  It is important to get each dose of this medication||
1743|141|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1743|142|D|right away for a new dosing schedule.||
1743|143|B|||
1743|144|R|STORAGE:  Not applicable. This medication is given in a clinic||
1743|145|R|and will not be stored at home.||
1743|146|B|||
1743|147|A|Information last revised October 2024.||
1743|148|A|Copyright(c) 2025 First Databank, Inc.||
1743|149|B|||
1744|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1744|002|Z|does NOT have all possible information about this product. This||
1744|003|Z|information does not assure that this product is safe, effective,||
1744|004|Z|or appropriate for you. This information is not individual||
1744|005|Z|medical advice and does not substitute for the advice of your||
1744|006|Z|health care professional. Always ask your health care||
1744|007|Z|professional for complete information about this product and your||
1744|008|Z|specific health needs.||
1744|009|B|||
1744|010|T|SELEXIPAG - ORAL||
1744|011|F|(se-LEX-i-pag)||
1744|012|B|||
1744|013|C|COMMON BRAND NAME(S): Uptravi||
1744|014|B|||
1744|015|U|USES:  Selexipag is used to treat high blood pressure in the||
1744|016|U|lungs (pulmonary arterial hypertension-PAH). It is used to help||
1744|017|U|slow down worsening of PAH and to decrease the chance of needing||
1744|018|U|treatment in a hospital. Selexipag works by making it easier for||
1744|019|U|blood to flow through the arteries in your lungs. This effect||
1744|020|U|helps increase your ability to exercise.||
1744|021|B|||
1744|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1744|023|H|from your pharmacist before you start taking selexipag and each||
1744|024|H|time you get a refill. If you have any questions, ask your doctor||
1744|025|H|or pharmacist.||
1744|026|H|   Take this medication by mouth with or without food as directed||
1744|027|H|by your doctor, usually twice daily. Taking this medication with||
1744|028|H|food may lessen stomach upset.||
1744|029|H|   The manufacturer directs not to split, crush, or chew the||
1744|030|H|tablet before taking it. However, many similar drugs||
1744|031|H|(immediate-release tablets) can be split, crushed, or chewed.||
1744|032|H|Follow your doctor's directions on how to take this medication.||
1744|033|H|   The dosage is based on your medical condition, response to||
1744|034|H|treatment, and other medications you may be taking. Be sure to||
1744|035|H|tell your doctor and pharmacist about all the products you use||
1744|036|H|(including prescription drugs, nonprescription drugs, and herbal||
1744|037|H|products). To reduce your risk of side effects, your doctor may||
1744|038|H|direct you to start this medication at a low dose and gradually||
1744|039|H|increase your dose. Follow your doctor's instructions carefully.||
1744|040|H|   Use this medication regularly to get the most benefit from it.||
1744|041|H|To help you remember, take it at the same times each day.||
1744|042|H|   Tell your doctor if your condition does not get better or if||
1744|043|H|it gets worse.||
1744|044|B|||
1744|045|S|SIDE EFFECTS:  Headache, nausea, vomiting, diarrhea, loss of||
1744|046|S|appetite, flushing, jaw pain, joint/muscle pain, or pain in your||
1744|047|S|arms or legs may occur. If any of these effects last or get||
1744|048|S|worse, tell your doctor or pharmacist promptly.||
1744|049|S|   Remember that this medication has been prescribed because your||
1744|050|S|doctor has judged that the benefit to you is greater than the||
1744|051|S|risk of side effects. Many people using this medication do not||
1744|052|S|have serious side effects.||
1744|053|S|   A very serious allergic reaction to this drug is rare.||
1744|054|S|However, get medical help right away if you notice any symptoms||
1744|055|S|of a serious allergic reaction, including: rash, itching/swelling||
1744|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1744|057|S|breathing.||
1744|058|S|   This is not a complete list of possible side effects. If you||
1744|059|S|notice other effects not listed above, contact your doctor or||
1744|060|S|pharmacist.||
1744|061|S|   In the US -||
1744|062|S|   Call your doctor for medical advice about side effects. You||
1744|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1744|064|S|www.fda.gov/medwatch.||
1744|065|S|   In Canada - Call your doctor for medical advice about side||
1744|066|S|effects. You may report side effects to Health Canada at||
1744|067|S|1-866-234-2345.||
1744|068|B|||
1744|069|P|PRECAUTIONS:  Before using selexipag, tell your doctor or||
1744|070|P|pharmacist if you are allergic to it; or if you have any other||
1744|071|P|allergies. This product may contain inactive ingredients, which||
1744|072|P|can cause allergic reactions or other problems. Talk to your||
1744|073|P|pharmacist for more details.||
1744|074|P|   Before using this medication, tell your doctor or pharmacist||
1744|075|P|your medical history, especially of: liver disease.||
1744|076|P|   Before having surgery, tell your doctor or dentist about all||
1744|077|P|the products you use (including prescription drugs,||
1744|078|P|nonprescription drugs, and herbal products).||
1744|079|P|   During pregnancy, this medication should be used only when||
1744|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
1744|081|P|   It is unknown if this drug passes into breast milk. Consult||
1744|082|P|your doctor before breastfeeding.||
1744|083|B|||
1744|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1744|085|I|medications work or increase your risk for serious side effects.||
1744|086|I|This document does not contain all possible drug interactions.||
1744|087|I|Keep a list of all the products you use (including||
1744|088|I|prescription/nonprescription drugs and herbal products) and share||
1744|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
1744|090|I|the dosage of any medicines without your doctor's approval.||
1744|091|I|   Other medications can affect the removal of selexipag from||
1744|092|I|your body, which may affect how selexipag works. An example is||
1744|093|I|gemfibrozil.||
1744|094|B|||
1744|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1744|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1744|097|O|poison control center right away. US residents can call||
1744|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1744|099|B|||
1744|100|N|NOTES:  Do not share this medication with others.||
1744|101|B|||
1744|102|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1744|103|D|remember. If it is within 6 hours of the next dose, skip the||
1744|104|D|missed dose. Take your next dose at the regular time. Do not||
1744|105|D|double the dose to catch up. If you miss 3 or more days of||
1744|106|D|medication, ask your doctor how to safely restart selexipag.||
1744|107|B|||
1744|108|R|STORAGE:  Store at room temperature away from light and moisture.||
1744|109|R|Do not store in the bathroom. Keep all medications away from||
1744|110|R|children and pets.||
1744|111|R|   Do not flush medications down the toilet or pour them into a||
1744|112|R|drain unless instructed to do so. Properly discard this product||
1744|113|R|when it is expired or no longer needed. Consult your pharmacist||
1744|114|R|or local waste disposal company.||
1744|115|B|||
1744|116|A|Information last revised May 2024.||
1744|117|A|Copyright(c) 2025 First Databank, Inc.||
1744|118|B|||
1745|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1745|002|Z|does NOT have all possible information about this product. This||
1745|003|Z|information does not assure that this product is safe, effective,||
1745|004|Z|or appropriate for you. This information is not individual||
1745|005|Z|medical advice and does not substitute for the advice of your||
1745|006|Z|health care professional. Always ask your health care||
1745|007|Z|professional for complete information about this product and your||
1745|008|Z|specific health needs.||
1745|009|B|||
1745|010|T|AMPHETAMINE EXTENDED-RELEASE SUSPENSION - ORAL||
1745|011|F|(am-FET-a-meen)||
1745|012|B|||
1745|013|C|COMMON BRAND NAME(S): Adzenys ER, Dyanavel XR||
1745|014|B|||
1745|015|W|WARNING:  Misuse or abuse of amphetamines may cause serious||
1745|016|W|(possibly fatal) heart and blood pressure problems.||
1745|017|W|Amphetamine-type medications can be habit-forming. Use only as||
1745|018|W|directed. If you use this drug for a long time, you may become||
1745|019|W|dependent on it and may have withdrawal symptoms after stopping||
1745|020|W|the drug. Consult your doctor or pharmacist for more details. See||
1745|021|W|also How to Use section.||
1745|022|B|||
1745|023|U|USES:  This medication is used to treat attention deficit||
1745|024|U|hyperactivity disorder - ADHD. It works by changing the amounts||
1745|025|U|of certain natural substances in the brain. Amphetamine belongs||
1745|026|U|to a class of drugs known as stimulants. It can help increase||
1745|027|U|your ability to pay attention, stay focused on an activity, and||
1745|028|U|control behavior problems. It may also help you to organize your||
1745|029|U|tasks and improve listening skills.||
1745|030|B|||
1745|031|V|OTHER USES:  This section contains uses of this drug that are not||
1745|032|V|listed in the approved professional labeling for the drug but||
1745|033|V|that may be prescribed by your health care professional. Use this||
1745|034|V|drug for a condition that is listed in this section only if it||
1745|035|V|has been so prescribed by your health care professional.||
1745|036|V|   This drug may also be used for a certain sleeping disorder||
1745|037|V|(narcolepsy). It should not be used to treat tiredness or to hold||
1745|038|V|off sleep in people who do not have a sleep disorder.||
1745|039|B|||
1745|040|H|HOW TO USE:  Read the Medication Guide provided by your||
1745|041|H|pharmacist before you start taking amphetamine and each time you||
1745|042|H|get a refill. If you have any questions, ask your doctor or||
1745|043|H|pharmacist.||
1745|044|H|   Take this medication by mouth with or without food as directed||
1745|045|H|by your doctor, usually once daily in the morning. Taking this||
1745|046|H|medication late in the day may cause trouble sleeping (insomnia).||
1745|047|H|   Shake the bottle well before each use. Carefully measure the||
1745|048|H|dose using a special measuring device/spoon. Do not use a||
1745|049|H|household spoon because you may not get the correct dose.||
1745|050|H|   Do not drink alcoholic beverages while taking this medication.||
1745|051|H|Drinking alcohol may release all of the drug at once, increasing||
1745|052|H|the risk of side effects.||
1745|053|H|   The dosage is based on your medical condition and response to||
1745|054|H|treatment. To reduce your risk of side effects, your doctor may||
1745|055|H|direct you to start this medication at a low dose and gradually||
1745|056|H|increase your dose. Follow your doctor's instructions carefully.||
1745|057|H|   Use this medication regularly to get the most benefit from it.||
1745|058|H|To help you remember, take it at the same time each day.||
1745|059|H|   During treatment, your doctor may occasionally recommend||
1745|060|H|stopping the medication for a short time to see whether there are||
1745|061|H|any changes in your behavior and whether the medication is still||
1745|062|H|needed.||
1745|063|H|   Do not increase your dose or use this drug more often or for||
1745|064|H|longer than prescribed. Your condition will not improve any||
1745|065|H|faster, and your risk of side effects will increase.||
1745|066|H|   If you suddenly stop using this medication, you may have||
1745|067|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
1745|068|H|mental/mood changes like depression). To help prevent withdrawal,||
1745|069|H|your doctor may lower your dose slowly. Withdrawal is more likely||
1745|070|H|if you have used this medication for a long time or in high||
1745|071|H|doses. Tell your doctor or pharmacist right away if you have||
1745|072|H|withdrawal.||
1745|073|H|   When this medication is used for a long time, it may not work||
1745|074|H|as well. Talk with your doctor if this medication stops working||
1745|075|H|well.||
1745|076|H|   Though it helps many people, this medication may sometimes||
1745|077|H|cause addiction. This risk may be higher if you have a substance||
1745|078|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1745|079|H|Take this medication exactly as prescribed to lower the risk of||
1745|080|H|addiction. Ask your doctor or pharmacist for more details.||
1745|081|H|   Tell your doctor if you do not get better or if you get worse.||
1745|082|B|||
1745|083|S|SIDE EFFECTS:  Loss of appetite, weight loss, dry mouth, stomach||
1745|084|S|upset/pain, nausea/vomiting, dizziness, headache, diarrhea,||
1745|085|S|fever, nervousness, or trouble sleeping may occur. If any of||
1745|086|S|these effects last or get worse, tell your doctor or pharmacist||
1745|087|S|promptly.||
1745|088|S|   Remember that this medication has been prescribed because your||
1745|089|S|doctor has judged that the benefit to you is greater than the||
1745|090|S|risk of side effects. Many people using this medication do not||
1745|091|S|have serious side effects.||
1745|092|S|   This medication may raise your blood pressure. Check your||
1745|093|S|blood pressure regularly and tell your doctor if the results are||
1745|094|S|high.||
1745|095|S|   Tell your doctor right away if you have any serious side||
1745|096|S|effects, such as: signs of blood flow problems in the fingers or||
1745|097|S|toes (such as coldness, numbness, pain, or skin color changes),||
1745|098|S|unusual wounds on the fingers or toes, pounding/irregular||
1745|099|S|heartbeat, mental/mood/behavior changes (such as agitation,||
1745|100|S|aggression, mood swings, depression, abnormal thoughts, thoughts||
1745|101|S|of suicide), uncontrolled movements (such as twitching, shaking),||
1745|102|S|continuous chewing movements/teeth grinding, outbursts of||
1745|103|S|words/sounds that are hard to control, vision changes (such as||
1745|104|S|blurred vision), change in sexual ability/desire,||
1745|105|S|frequent/prolonged erections (in males).||
1745|106|S|   Get medical help right away if you have any very serious side||
1745|107|S|effects, such as: fainting, seizures, severe headache,||
1745|108|S|fast/pounding/irregular heartbeat, symptoms of a heart attack||
1745|109|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
1745|110|S|sweating), signs of a stroke (such as weakness on one side of the||
1745|111|S|body, trouble speaking, sudden vision changes, confusion).||
1745|112|S|   This medication may increase serotonin and rarely cause a very||
1745|113|S|serious condition called serotonin syndrome/toxicity. The risk||
1745|114|S|increases if you are also taking other drugs that increase||
1745|115|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1745|116|S|take (see Drug Interactions section). Get medical help right away||
1745|117|S|if you develop some of the following symptoms: fast heartbeat,||
1745|118|S|hallucinations, loss of coordination, severe dizziness, severe||
1745|119|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1745|120|S|unusual agitation/restlessness.||
1745|121|S|   A very serious allergic reaction to this drug is rare.||
1745|122|S|However, get medical help right away if you notice any symptoms||
1745|123|S|of a serious allergic reaction, such as: rash, itching/swelling||
1745|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1745|125|S|breathing.||
1745|126|S|   This is not a complete list of possible side effects. If you||
1745|127|S|notice other effects not listed above, contact your doctor or||
1745|128|S|pharmacist.||
1745|129|S|   In the US -||
1745|130|S|   Call your doctor for medical advice about side effects. You||
1745|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1745|132|S|www.fda.gov/medwatch.||
1745|133|S|   In Canada - Call your doctor for medical advice about side||
1745|134|S|effects. You may report side effects to Health Canada at||
1745|135|S|1-866-234-2345.||
1745|136|B|||
1745|137|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1745|138|P|pharmacist if you are allergic to it; or to other sympathomimetic||
1745|139|P|drugs (such as lisdexamfetamine, dextroamphetamine); or if you||
1745|140|P|have any other allergies. This product may contain inactive||
1745|141|P|ingredients, which can cause allergic reactions or other||
1745|142|P|problems. Talk to your pharmacist for more details.||
1745|143|P|   Before using this medication, tell your doctor or pharmacist||
1745|144|P|your medical history, especially of: high blood pressure, stroke,||
1745|145|P|personal or family history of heart problems (such as irregular||
1745|146|P|heartbeat, heart attack, heart failure, heart valve problem),||
1745|147|P|blood circulation problems (such as Raynaud's disease), glaucoma,||
1745|148|P|personal or family history of a substance use disorder (such as||
1745|149|P|overuse of or addiction to drugs/alcohol), personal or family||
1745|150|P|history of mental/mood disorders (such as bipolar disorder,||
1745|151|P|depression, psychosis, suicidal thoughts), personal or family||
1745|152|P|history of uncontrolled muscle movements (motor tics, Tourette's||
1745|153|P|syndrome), overactive thyroid (hyperthyroidism), seizures.||
1745|154|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1745|155|P|can make you more dizzy. Do not drive, use machinery, or do||
1745|156|P|anything that needs alertness until you can do it safely. Avoid||
1745|157|P|alcoholic beverages. Talk to your doctor if you are using||
1745|158|P|marijuana (cannabis).||
1745|159|P|   Before having surgery, tell your doctor or dentist about all||
1745|160|P|the products you use (such as prescription drugs, nonprescription||
1745|161|P|drugs, and herbal products).||
1745|162|P|   Children (especially those younger than 6) may be more||
1745|163|P|sensitive to the side effects of this drug, especially weight||
1745|164|P|loss. This medication may slow down a child's growth. The doctor||
1745|165|P|may recommend temporarily stopping the medication from time to||
1745|166|P|time to reduce this risk. Monitor your child's weight and height.||
1745|167|P|Consult your doctor or pharmacist for more details.||
1745|168|P|   Older adults may be more sensitive to the side effects of this||
1745|169|P|drug, especially chest pain, trouble sleeping, or weight loss.||
1745|170|P|   During pregnancy, this medication should be used only when||
1745|171|P|clearly needed. Discuss the risks and benefits with your doctor.||
1745|172|P|Infants born to mothers who are dependent on this medication may||
1745|173|P|be born too soon (premature) and have low birth weight. They may||
1745|174|P|also have withdrawal symptoms. Tell your doctor right away if you||
1745|175|P|notice possible mood changes, agitation, or unusual tiredness in||
1745|176|P|your newborn.||
1745|177|P|   This medication passes into breast milk and may have||
1745|178|P|undesirable effects on a nursing infant. Breastfeeding is not||
1745|179|P|recommended while using this medication. Consult your doctor||
1745|180|P|before breastfeeding.||
1745|181|B|||
1745|182|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1745|183|I|medications work or increase your risk for serious side effects.||
1745|184|I|This document does not contain all possible drug interactions.||
1745|185|I|Keep a list of all the products you use (such as||
1745|186|I|prescription/nonprescription drugs and herbal products) and share||
1745|187|I|it with your doctor and pharmacist. Do not start, stop, or change||
1745|188|I|the dosage of any medicines without your doctor's approval.||
1745|189|I|   Taking MAO inhibitors with this medication may cause a serious||
1745|190|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1745|191|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1745|192|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1745|193|I|selegiline, tranylcypromine) during treatment with this||
1745|194|I|medication. Most MAO inhibitors should also not be taken for two||
1745|195|I|weeks before treatment with this medication. Ask your doctor when||
1745|196|I|to start or stop taking this medication.||
1745|197|I|   Some products have ingredients that could raise your heart||
1745|198|I|rate or blood pressure. Tell your pharmacist what products you||
1745|199|I|are using, and ask how to use them safely (especially||
1745|200|I|cough-and-cold products or diet aids).||
1745|201|I|   The risk of serotonin syndrome/toxicity increases if you are||
1745|202|I|also taking other drugs that increase serotonin. Examples include||
1745|203|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
1745|204|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1745|205|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1745|206|I|serotonin syndrome/toxicity may be more likely when you start or||
1745|207|I|increase the dose of these drugs.||
1745|208|I|   Amphetamine is very similar to dextroamphetamine or||
1745|209|I|lisdexamfetamine. Do not use medications containing||
1745|210|I|dextroamphetamine or lisdexamfetamine while using amphetamine.||
1745|211|I|   This medication may interfere with certain medical/lab tests||
1745|212|I|(such as blood and urine steroid levels, brain scan for||
1745|213|I|Parkinson's disease), possibly causing false test results. Make||
1745|214|I|sure lab personnel and all your doctors know you use this drug.||
1745|215|B|||
1745|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1745|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1745|218|O|poison control center right away. US residents can call||
1745|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1745|220|O|Symptoms of overdose may include: severe mental/mood changes,||
1745|221|O|seizures, severe headache, severe restlessness, fast breathing.||
1745|222|B|||
1745|223|N|NOTES:  Do not share this medication with others. Sharing it is||
1745|224|N|against the law.||
1745|225|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
1745|226|N|growth monitoring in children) may be done while you are taking||
1745|227|N|this medication. Keep all medical and lab appointments. Consult||
1745|228|N|your doctor for more details.||
1745|229|N|   There are different brands and forms of this medication||
1745|230|N|available. Not all have the same effects. Do not change brands or||
1745|231|N|forms without consulting your doctor or pharmacist.||
1745|232|B|||
1745|233|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
1745|234|D|in the morning hours. If it is after noon or near the time of the||
1745|235|D|next dose, skip the missed dose. Take your next dose at the||
1745|236|D|regular time. Do not double the dose to catch up.||
1745|237|B|||
1745|238|R|STORAGE:  Store at room temperature. Keep all medications away||
1745|239|R|from children and pets.||
1745|240|R|   Do not flush medications down the toilet or pour them into a||
1745|241|R|drain unless instructed to do so. Properly discard this product||
1745|242|R|when it is expired or no longer needed. Consult your pharmacist||
1745|243|R|or local waste disposal company.||
1745|244|B|||
1745|245|A|Information last revised July 2025.||
1745|246|A|Copyright(c) 2025 First Databank, Inc.||
1745|247|B|||
1746|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1746|002|Z|does NOT have all possible information about this product. This||
1746|003|Z|information does not assure that this product is safe, effective,||
1746|004|Z|or appropriate for you. This information is not individual||
1746|005|Z|medical advice and does not substitute for the advice of your||
1746|006|Z|health care professional. Always ask your health care||
1746|007|Z|professional for complete information about this product and your||
1746|008|Z|specific health needs.||
1746|009|B|||
1746|010|T|METHYLPHENIDATE EXTENDED-RELEASE CHEWABLE TABLET - ORAL||
1746|011|F|(METH-il-FEN-i-date)||
1746|012|B|||
1746|013|C|COMMON BRAND NAME(S): QuilliChew ER||
1746|014|B|||
1746|015|W|WARNING:  Misuse or abuse of methylphenidate may cause serious||
1746|016|W|(possibly fatal) heart and blood pressure problems.||
1746|017|W|   This medication can be habit-forming and should be used||
1746|018|W|cautiously by people who have mental/mood disorders or a||
1746|019|W|substance use disorder (such as overuse of or addiction to||
1746|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
1746|021|W|you have a personal or family history of a substance use||
1746|022|W|disorder. Do not increase your dose, use it more often, or use it||
1746|023|W|for a longer time or in a different way than prescribed. Doing so||
1746|024|W|may result in a decrease in the effect of this drug, drug||
1746|025|W|dependence, or abnormal thoughts/behavior.||
1746|026|W|   Your doctor may monitor you for a while after the medication||
1746|027|W|is stopped, especially if you have taken this drug for a long||
1746|028|W|time or in high doses. (See also How to Use section.)||
1746|029|B|||
1746|030|U|USES:  This medication is used to treat attention deficit||
1746|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
1746|032|U|of certain natural substances in the brain. Methylphenidate||
1746|033|U|belongs to a class of drugs known as stimulants. It can help||
1746|034|U|increase your ability to pay attention, stay focused on an||
1746|035|U|activity, and control behavior problems. It may also help you to||
1746|036|U|organize your tasks and improve listening skills.||
1746|037|B|||
1746|038|H|HOW TO USE:  Read the Medication Guide provided by your||
1746|039|H|pharmacist before you start taking methylphenidate and each time||
1746|040|H|you get a refill. If you have any questions, ask your doctor or||
1746|041|H|pharmacist.||
1746|042|H|   Take this medication by mouth with or without food as directed||
1746|043|H|by your doctor, usually once daily in the morning. Chew||
1746|044|H|thoroughly and then swallow. Taking this medication late in the||
1746|045|H|day may cause trouble sleeping (insomnia).||
1746|046|H|   Do not drink alcoholic beverages while taking this medication.||
1746|047|H|Drinking alcohol may release all of the drug at once, increasing||
1746|048|H|the risk of side effects.||
1746|049|H|   The dosage is based on your medical condition and response to||
1746|050|H|treatment. To reduce your risk of side effects, your doctor may||
1746|051|H|direct you to start this medication at a low dose and gradually||
1746|052|H|increase your dose. Follow your doctor's instructions carefully.||
1746|053|H|   Use this medication regularly to get the most benefit from it.||
1746|054|H|To help you remember, take it at the same time each day.||
1746|055|H|   During treatment, your doctor may occasionally recommend||
1746|056|H|stopping the medication for a short time to see whether there are||
1746|057|H|any changes in your behavior and whether the medication is still||
1746|058|H|needed.||
1746|059|H|   Do not increase your dose or use this drug more often or for||
1746|060|H|longer than prescribed. Your condition will not improve any||
1746|061|H|faster, and your risk of side effects will increase.||
1746|062|H|   If you suddenly stop using this medication, you may have||
1746|063|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
1746|064|H|mental/mood changes like depression). To help prevent withdrawal,||
1746|065|H|your doctor may lower your dose slowly. Withdrawal is more likely||
1746|066|H|if you have used this medication for a long time or in high||
1746|067|H|doses. Tell your doctor or pharmacist right away if you have||
1746|068|H|withdrawal.||
1746|069|H|   When this medication is used for a long time, it may not work||
1746|070|H|as well. Talk with your doctor if this medication stops working||
1746|071|H|well.||
1746|072|H|   Though it helps many people, this medication may sometimes||
1746|073|H|cause addiction. This risk may be higher if you have a substance||
1746|074|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1746|075|H|Take this medication exactly as prescribed to lower the risk of||
1746|076|H|addiction. Ask your doctor or pharmacist for more details.||
1746|077|H|   Tell your doctor if you do not get better or if you get worse.||
1746|078|B|||
1746|079|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
1746|080|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
1746|081|S|If any of these effects last or get worse, tell your doctor or||
1746|082|S|pharmacist promptly.||
1746|083|S|   Remember that this medication has been prescribed because your||
1746|084|S|doctor has judged that the benefit to you is greater than the||
1746|085|S|risk of side effects. Many people using this medication do not||
1746|086|S|have serious side effects.||
1746|087|S|   This medication may raise your blood pressure. Check your||
1746|088|S|blood pressure regularly and tell your doctor if the results are||
1746|089|S|high.||
1746|090|S|   Tell your doctor right away if you have any serious side||
1746|091|S|effects, such as: signs of blood flow problems in the fingers or||
1746|092|S|toes (such as coldness, numbness, pain, or skin color changes),||
1746|093|S|unusual wounds on the fingers or toes, fast/pounding/irregular||
1746|094|S|heartbeat, mental/mood/behavior changes (such as agitation,||
1746|095|S|aggression, mood swings, abnormal thoughts, thoughts of suicide),||
1746|096|S|uncontrolled muscle movements (such as twitching, shaking),||
1746|097|S|sudden outbursts of words/sounds that are hard to control, vision||
1746|098|S|changes (such as blurred vision).||
1746|099|S|   Get medical help right away if you have any very serious side||
1746|100|S|effects, such as: fainting, seizure, symptoms of a heart attack||
1746|101|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
1746|102|S|sweating), signs of a stroke (such as weakness on one side of the||
1746|103|S|body, trouble speaking, sudden vision changes, confusion).||
1746|104|S|   Rarely, males (including young boys and teens) may have a||
1746|105|S|painful or prolonged erection lasting 4 or more hours while using||
1746|106|S|this medication. Caregivers/parents should also be watchful for||
1746|107|S|this serious side effect in boys. If a painful or prolonged||
1746|108|S|erection occurs, stop using this drug and get medical help right||
1746|109|S|away, or permanent problems could occur. Ask your doctor or||
1746|110|S|pharmacist for more details.||
1746|111|S|   A very serious allergic reaction to this drug is rare.||
1746|112|S|However, get medical help right away if you notice any symptoms||
1746|113|S|of a serious allergic reaction, such as: rash, itching/swelling||
1746|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1746|115|S|breathing.||
1746|116|S|   This is not a complete list of possible side effects. If you||
1746|117|S|notice other effects not listed above, contact your doctor or||
1746|118|S|pharmacist.||
1746|119|S|   In the US -||
1746|120|S|   Call your doctor for medical advice about side effects. You||
1746|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1746|122|S|www.fda.gov/medwatch.||
1746|123|S|   In Canada - Call your doctor for medical advice about side||
1746|124|S|effects. You may report side effects to Health Canada at||
1746|125|S|1-866-234-2345.||
1746|126|B|||
1746|127|P|PRECAUTIONS:  See also Warning section.||
1746|128|P|   Before taking methylphenidate, tell your doctor or pharmacist||
1746|129|P|if you are allergic to it; or to dexmethylphenidate; or if you||
1746|130|P|have any other allergies. This product may contain inactive||
1746|131|P|ingredients, which can cause allergic reactions or other||
1746|132|P|problems. Talk to your pharmacist for more details.||
1746|133|P|   Before using this medication, tell your doctor or pharmacist||
1746|134|P|your medical history, especially of: high blood pressure, stroke,||
1746|135|P|personal or family history of heart problems (such as irregular||
1746|136|P|heartbeat, heart attack, heart failure, heart valve problem),||
1746|137|P|blood circulation problems (such as Raynaud's disease), glaucoma,||
1746|138|P|personal or family history of regular use/abuse of drugs/alcohol,||
1746|139|P|personal or family history of mental/mood disorders (such as||
1746|140|P|bipolar disorder, depression, psychosis, suicidal thoughts),||
1746|141|P|personal or family history of uncontrolled muscle movements||
1746|142|P|(motor tics, Tourette's syndrome), overactive thyroid||
1746|143|P|(hyperthyroidism), seizures.||
1746|144|P|   This medication may contain aspartame. If you have||
1746|145|P|phenylketonuria (PKU) or any other condition that requires you to||
1746|146|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
1746|147|P|doctor or pharmacist about using this medication safely.||
1746|148|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1746|149|P|can make you more dizzy. Do not drive, use machinery, or do||
1746|150|P|anything that needs alertness until you can do it safely. Avoid||
1746|151|P|alcoholic beverages. Talk to your doctor if you are using||
1746|152|P|marijuana (cannabis).||
1746|153|P|   Before having surgery, tell your doctor or dentist about all||
1746|154|P|the products you use (such as prescription drugs, nonprescription||
1746|155|P|drugs, and herbal products).||
1746|156|P|   Children (especially those younger than 6) may be more||
1746|157|P|sensitive to the side effects of this drug, especially weight||
1746|158|P|loss. If used for a long time, this drug may affect a child's||
1746|159|P|growth rate, weight, and final adult height. To reduce the risk,||
1746|160|P|the doctor may recommend briefly stopping the medication from||
1746|161|P|time to time. Check the child's weight and height regularly, and||
1746|162|P|consult your doctor or pharmacist for more details.||
1746|163|P|   Older adults may be more sensitive to the side effects of this||
1746|164|P|drug, especially trouble sleeping, weight loss, or chest pain.||
1746|165|P|   During pregnancy, methylphenidate should be used only when||
1746|166|P|clearly needed. Discuss the risks and benefits with your doctor.||
1746|167|P|   This medication passes into breast milk. Consult your doctor||
1746|168|P|before breastfeeding.||
1746|169|B|||
1746|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1746|171|I|medications work or increase your risk for serious side effects.||
1746|172|I|This document does not contain all possible drug interactions.||
1746|173|I|Keep a list of all the products you use (such as||
1746|174|I|prescription/nonprescription drugs and herbal products) and share||
1746|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
1746|176|I|the dosage of any medicines without your doctor's approval.||
1746|177|I|   Taking MAO inhibitors with this medication may cause a serious||
1746|178|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1746|179|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1746|180|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1746|181|I|selegiline, tranylcypromine) during treatment with this||
1746|182|I|medication. Most MAO inhibitors should also not be taken for two||
1746|183|I|weeks before treatment with this medication. Ask your doctor when||
1746|184|I|to start or stop taking this medication.||
1746|185|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
1746|186|I|use medications containing dexmethylphenidate while using||
1746|187|I|methylphenidate.||
1746|188|I|   This medication may interfere with certain medical/lab tests||
1746|189|I|(such as brain scan for Parkinson's disease), possibly causing||
1746|190|I|false test results. Make sure lab personnel and all your doctors||
1746|191|I|know you use this drug.||
1746|192|B|||
1746|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1746|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1746|195|O|poison control center right away. US residents can call||
1746|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1746|197|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
1746|198|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
1746|199|O|loss of consciousness.||
1746|200|B|||
1746|201|N|NOTES:  Do not share this medication with others. Sharing it is||
1746|202|N|against the law.||
1746|203|N|   Lab and/or medical tests (such as blood pressure, complete||
1746|204|N|blood count, height/weight monitoring in children) may be done||
1746|205|N|while you are taking this medication. Keep all medical and lab||
1746|206|N|appointments. Consult your doctor for more details.||
1746|207|N|   There are different brands and forms of this medication||
1746|208|N|available. Not all have the same effects. Do not change brands or||
1746|209|N|forms without consulting your doctor or pharmacist.||
1746|210|B|||
1746|211|D|MISSED DOSE:  If you miss a dose, contact your doctor or||
1746|212|D|pharmacist right away. Do not double the dose to catch up.||
1746|213|B|||
1746|214|R|STORAGE:  Store at room temperature away from light and moisture.||
1746|215|R|Do not store in the bathroom. Keep all medications away from||
1746|216|R|children and pets.||
1746|217|R|   Do not flush medications down the toilet or pour them into a||
1746|218|R|drain unless instructed to do so. Properly discard this product||
1746|219|R|when it is expired or no longer needed. Consult your pharmacist||
1746|220|R|or local waste disposal company.||
1746|221|B|||
1746|222|A|Information last revised July 2025.||
1746|223|A|Copyright(c) 2025 First Databank, Inc.||
1746|224|B|||
1747|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1747|002|Z|does NOT have all possible information about this product. This||
1747|003|Z|information does not assure that this product is safe, effective,||
1747|004|Z|or appropriate for you. This information is not individual||
1747|005|Z|medical advice and does not substitute for the advice of your||
1747|006|Z|health care professional. Always ask your health care||
1747|007|Z|professional for complete information about this product and your||
1747|008|Z|specific health needs.||
1747|009|B|||
1747|010|T|ELBASVIR/GRAZOPREVIR - ORAL||
1747|011|F|(ELB-as-vir/graz-OH-pre-vir)||
1747|012|B|||
1747|013|C|COMMON BRAND NAME(S): Zepatier||
1747|014|B|||
1747|015|W|WARNING:  Although this product is used to treat hepatitis C, it||
1747|016|W|may rarely cause serious liver problems. It may make other liver||
1747|017|W|problems (such as hepatitis B) get worse. Before starting this||
1747|018|W|product, tell your doctor if you have ever had hepatitis B or any||
1747|019|W|other liver problems. See also Precautions section. Tell your||
1747|020|W|doctor right away if you have new or worsening symptoms of liver||
1747|021|W|disease, such as nausea/vomiting that doesn't stop, loss of||
1747|022|W|appetite, stomach/abdominal pain, dark urine or yellowing||
1747|023|W|eyes/skin.||
1747|024|B|||
1747|025|U|USES:  This medication is used to treat chronic (long-lasting)||
1747|026|U|hepatitis C, a viral infection of the liver. Elbasvir and||
1747|027|U|grazoprevir work by reducing the amount of hepatitis C virus in||
1747|028|U|your body, which helps your immune system fight the infection and||
1747|029|U|may help your liver recover. This product may also be used with||
1747|030|U|certain other medications (such as ribavirin). Chronic hepatitis||
1747|031|U|C infection can cause serious liver problems such as scarring||
1747|032|U|(cirrhosis) or liver cancer.||
1747|033|U|   It is not known if this treatment can prevent you from passing||
1747|034|U|the virus to others. Do not share needles, and practice "safer||
1747|035|U|sex" (including the use of latex condoms) to lower the risk of||
1747|036|U|passing the virus to others.||
1747|037|B|||
1747|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1747|039|H|from your pharmacist before you start taking this product and||
1747|040|H|each time you get a refill. If you have any questions, ask your||
1747|041|H|doctor or pharmacist.||
1747|042|H|   Remove one dose from the original package just before taking.||
1747|043|H|Take this medication by mouth with or without food as directed by||
1747|044|H|your doctor, usually once a day.||
1747|045|H|   This product works best when the amount of drug in your body||
1747|046|H|is kept at a constant level. Take this product at evenly spaced||
1747|047|H|intervals. To help you remember, take it at the same time each||
1747|048|H|day.||
1747|049|H|   Continue to take this product for the full length of time||
1747|050|H|prescribed, even if symptoms disappear after a short time.||
1747|051|H|Stopping the medication too early may result in a return of the||
1747|052|H|infection.||
1747|053|B|||
1747|054|S|SIDE EFFECTS:  See also Warning section.||
1747|055|S|   Tiredness, headache, or nausea may occur. If any of these||
1747|056|S|effects last or get worse, tell your doctor or pharmacist||
1747|057|S|promptly.||
1747|058|S|   Remember that this product has been prescribed because your||
1747|059|S|doctor has judged that the benefit to you is greater than the||
1747|060|S|risk of side effects. Many people using this product do not have||
1747|061|S|serious side effects.||
1747|062|S|   A very serious allergic reaction to this product is rare.||
1747|063|S|However, get medical help right away if you notice any symptoms||
1747|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1747|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1747|066|S|breathing.||
1747|067|S|   This is not a complete list of possible side effects. If you||
1747|068|S|notice other effects not listed above, contact your doctor or||
1747|069|S|pharmacist.||
1747|070|S|   In the US -||
1747|071|S|   Call your doctor for medical advice about side effects. You||
1747|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1747|073|S|www.fda.gov/medwatch.||
1747|074|S|   In Canada - Call your doctor for medical advice about side||
1747|075|S|effects. You may report side effects to Health Canada at||
1747|076|S|1-866-234-2345.||
1747|077|B|||
1747|078|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1747|079|P|pharmacist if you are allergic to elbasvir or grazoprevir; or if||
1747|080|P|you have any other allergies. This product may contain inactive||
1747|081|P|ingredients, which can cause allergic reactions or other||
1747|082|P|problems. Talk to your pharmacist for more details.||
1747|083|P|   Before using this product, tell your doctor or pharmacist your||
1747|084|P|medical history, especially of: other liver problems (such as||
1747|085|P|hepatitis B, liver cancer), overuse of or addiction to alcohol,||
1747|086|P|HIV infection, diabetes.||
1747|087|P|   If you have diabetes, your blood sugar may be lower with||
1747|088|P|hepatitis C treatment. This can increase your risk of low blood||
1747|089|P|sugar, so your doctor may adjust your diabetes treatment plan.||
1747|090|P|Tell your doctor right away if you have symptoms of low blood||
1747|091|P|sugar such as sudden sweating, shaking, fast heartbeat, hunger,||
1747|092|P|blurred vision, dizziness, or tingling hands/feet.||
1747|093|P|   Before having surgery, tell your doctor or dentist about all||
1747|094|P|the products you use (such as prescription drugs, nonprescription||
1747|095|P|drugs, and herbal products).||
1747|096|P|   During pregnancy, this product should be used only when||
1747|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
1747|098|P|   If this product is used in combination with ribavirin, it must||
1747|099|P|not be used during pregnancy by either the pregnant woman or her||
1747|100|P|male partner. Ribavirin may harm an unborn baby. Reliable forms||
1747|101|P|of birth control must be used whenever at least one sexual||
1747|102|P|partner is using these medicines together. Female patients should||
1747|103|P|keep using birth control for 9 months after stopping treatment.||
1747|104|P|Male patients should keep using birth control for 6 months after||
1747|105|P|stopping treatment. If you or your partner becomes pregnant, or||
1747|106|P|if you think you or your partner may be pregnant, tell your||
1747|107|P|doctor right away.||
1747|108|P|   It is unknown if the medications in this product pass into||
1747|109|P|breast milk. Consult your doctor before breastfeeding.||
1747|110|B|||
1747|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1747|112|I|medications work or increase your risk for serious side effects.||
1747|113|I|This document does not contain all possible drug interactions.||
1747|114|I|Keep a list of all the products you use (such as||
1747|115|I|prescription/nonprescription drugs and herbal products) and share||
1747|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1747|117|I|the dosage of any medicines without your doctor's approval.||
1747|118|I|   Other medications can affect the removal of this product from||
1747|119|I|your body, which may affect how this product works. Examples||
1747|120|I|include azole antifungals (such as ketoconazole), bosentan,||
1747|121|I|cyclosporine, efavirenz, etravirine, modafinil, nafcillin, HIV||
1747|122|I|protease inhibitors (such as atazanavir), rifamycins (such as||
1747|123|I|rifampin), certain drugs used to treat seizures (such as||
1747|124|I|carbamazepine, phenytoin), St. John's wort, among others.||
1747|125|B|||
1747|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1747|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1747|128|O|poison control center right away. US residents can call||
1747|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1747|130|B|||
1747|131|N|NOTES:  Do not share this product with others.||
1747|132|N|   Lab tests (such as liver function, tests for hepatitis B and||
1747|133|N|C) should be done before you start using this medication, while||
1747|134|N|you are using it, and after completing treatment. Keep all||
1747|135|N|medical and lab appointments.||
1747|136|N|   If you are using this product with ribavirin, it is||
1747|137|N|recommended that female patients or female partners of male||
1747|138|N|patients take a pregnancy test before starting treatment.||
1747|139|N|Pregnancy tests should continue to be done while using this||
1747|140|N|medication and for some time after this medication is stopped to||
1747|141|N|make sure no pregnancy occurs (for 9 months for female patients||
1747|142|N|and for 6 months for female partners of male patients).||
1747|143|B|||
1747|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1747|145|D|remember. If it is within 8 hours of the next dose, skip the||
1747|146|D|missed dose. Take your next dose at the regular time. Do not||
1747|147|D|double the dose to catch up.||
1747|148|B|||
1747|149|R|STORAGE:  Store in the original package at room temperature away||
1747|150|R|from light and moisture. Do not store in the bathroom. Keep all||
1747|151|R|medications away from children and pets.||
1747|152|R|   Do not flush medications down the toilet or pour them into a||
1747|153|R|drain unless instructed to do so. Properly discard this product||
1747|154|R|when it is expired or no longer needed. Consult your pharmacist||
1747|155|R|or local waste disposal company.||
1747|156|B|||
1747|157|A|Information last revised July 2024.||
1747|158|A|Copyright(c) 2025 First Databank, Inc.||
1747|159|B|||
1748|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1748|002|Z|does NOT have all possible information about this product. This||
1748|003|Z|information does not assure that this product is safe, effective,||
1748|004|Z|or appropriate for you. This information is not individual||
1748|005|Z|medical advice and does not substitute for the advice of your||
1748|006|Z|health care professional. Always ask your health care||
1748|007|Z|professional for complete information about this product and your||
1748|008|Z|specific health needs.||
1748|009|B|||
1748|010|T|CHOLERA VACCINE - ORAL||
1748|011|F|(KOL-er-a vak-SEEN)||
1748|012|B|||
1748|013|U|USES:  This vaccine is used to help prevent infections caused by||
1748|014|U|certain bacteria (V. cholerae and E. coli). This can help prevent||
1748|015|U|traveler's diarrhea and cholera. People can get infected by||
1748|016|U|eating food or drinking water that has been contaminated. This||
1748|017|U|vaccine is recommended for people who are traveling to areas||
1748|018|U|where these infections are common. This vaccine works by||
1748|019|U|increasing the body's natural defense (immunity) against the||
1748|020|U|bacteria.||
1748|021|U|   Vaccines may not fully protect everyone who receives them.||
1748|022|U|While traveling, you should still avoid contaminated food or||
1748|023|U|water (such as by drinking only bottled or boiled water, eating||
1748|024|U|only fully cooked food). Ask your health care professional for||
1748|025|U|more details.||
1748|026|B|||
1748|027|H|HOW TO USE:  Read all vaccine information available from your||
1748|028|H|health care professional before taking the vaccine. If you have||
1748|029|H|any questions, ask your health care professional.||
1748|030|H|   Take this vaccine by mouth as directed by the health care||
1748|031|H|professional, usually once a week. Do not eat or drink or take||
1748|032|H|any medications 1 hour before and 1 hour after taking this||
1748|033|H|vaccine.||
1748|034|H|   To prepare the vaccine dose, open the buffer packet and pour||
1748|035|H|its contents into 5 ounces/150 milliliters of cool water. Do not||
1748|036|H|mix with any other liquids. Stir gently until the powder||
1748|037|H|dissolves. If you are giving this vaccine to a child younger than||
1748|038|H|6 years, pour out half of the mixed buffer liquid before adding||
1748|039|H|the liquid from the vaccine vial. Shake the vaccine vial well||
1748|040|H|before adding the contents to the buffer liquid. Stir gently and||
1748|041|H|drink the mixture right away. The mixture may also be stored at||
1748|042|H|room temperature but it must be taken within 2 hours of mixing.||
1748|043|H|   Vaccines are usually given in a series of doses to provide the||
1748|044|H|best protection. In some cases, only one dose may be needed.||
1748|045|H|Closely follow the vaccination schedule provided by your health||
1748|046|H|care professional. To help you remember, mark your calendar with||
1748|047|H|a reminder. You should complete the course of the vaccine at||
1748|048|H|least 1 week before traveling to at-risk areas.||
1748|049|H|   This vaccine should not be taken at the same time as other||
1748|050|H|vaccines taken by mouth (such as typhoid vaccine).||
1748|051|B|||
1748|052|S|SIDE EFFECTS:  Vomiting may occur. If this effect lasts or gets||
1748|053|S|worse, tell your health care professional promptly.||
1748|054|S|   Remember that this vaccine has been prescribed because your||
1748|055|S|health care professional has judged that the benefit to you is||
1748|056|S|greater than the risk of side effects. Many people using this||
1748|057|S|vaccine do not have serious side effects.||
1748|058|S|   A very serious allergic reaction to this vaccine is rare.||
1748|059|S|However, get medical help right away if you notice any symptoms||
1748|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1748|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1748|062|S|breathing.||
1748|063|S|   This is not a complete list of possible side effects. If you||
1748|064|S|notice other effects not listed above, contact your health care||
1748|065|S|professional.||
1748|066|S|   Contact the health care professional for medical advice about||
1748|067|S|side effects. The following numbers do not provide medical||
1748|068|S|advice, but in the US you may report side effects to the Vaccine||
1748|069|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1748|070|S|Canada, you may call the Vaccine Safety Section at Public Health||
1748|071|S|Agency of Canada at 1-866-844-0018.||
1748|072|B|||
1748|073|P|PRECAUTIONS:  Before you take this vaccine, tell the health care||
1748|074|P|professional if you are allergic to it; or if you have any other||
1748|075|P|allergies. This product may contain inactive ingredients, which||
1748|076|P|can cause allergic reactions or other problems. Talk to your||
1748|077|P|health care professional for more details.||
1748|078|P|   Before taking this vaccine, tell your health care professional||
1748|079|P|your medical history, especially of: current fever/illness,||
1748|080|P|current stomach problems (such as diarrhea/vomiting that doesn't||
1748|081|P|go away), immune system disorders (such as due to HIV infection,||
1748|082|P|certain cancers such as leukemia/lymphoma, cancer or radiation||
1748|083|P|treatment), vaccination history (including previous reactions to||
1748|084|P|any vaccines).||
1748|085|P|   This vaccine contains sodium. Consult your health care||
1748|086|P|professional if you are on a salt-restricted diet or if you have||
1748|087|P|a condition that could be worsened by an increase in salt intake||
1748|088|P|(such as heart failure).||
1748|089|P|   During pregnancy, this vaccine should be taken only when||
1748|090|P|clearly needed. Discuss the risks and benefits with your health||
1748|091|P|care professional.||
1748|092|P|   It is unknown if this vaccine passes into breast milk. Consult||
1748|093|P|your health care professional before breastfeeding.||
1748|094|B|||
1748|095|I|DRUG INTERACTIONS:  See also How to Use section.||
1748|096|I|   Drug interactions may change how your medications work or||
1748|097|I|increase your risk for serious side effects. This document does||
1748|098|I|not contain all possible drug interactions. Keep a list of all||
1748|099|I|the products you use (such as prescription/nonprescription drugs||
1748|100|I|and herbal products) and share it with your health care||
1748|101|I|professional. Do not start, stop, or change the dosage of any||
1748|102|I|medicines without your doctor's approval.||
1748|103|I|   Some products that may interact with this vaccine are: drugs||
1748|104|I|that weaken the immune system (including cyclosporine,||
1748|105|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1748|106|I|prednisone).||
1748|107|B|||
1748|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1748|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1748|110|O|poison control center right away. US residents can call||
1748|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1748|112|B|||
1748|113|N|NOTES:  Keep all medical and lab appointments.||
1748|114|N|   Keep vaccine records for yourself and your children and||
1748|115|N|provide them to the health care professionals to prevent||
1748|116|N|unnecessary re-vaccinations.||
1748|117|B|||
1748|118|D|MISSED DOSE:  It is important to take each dose of this||
1748|119|D|medication as scheduled. If you miss a dose, ask your health care||
1748|120|D|professional right away for a new dosing schedule. Do not double||
1748|121|D|the dose to catch up.||
1748|122|B|||
1748|123|R|STORAGE:  See also How to Use section.||
1748|124|R|   Store in the refrigerator. Do not freeze. The powder packets||
1748|125|R|may be stored separately at room temperature. Keep all||
1748|126|R|medications away from children and pets.||
1748|127|R|   Do not flush medications down the toilet or pour them into a||
1748|128|R|drain unless instructed to do so. Properly discard this product||
1748|129|R|when it is expired or no longer needed. Consult your pharmacist||
1748|130|R|or local waste disposal company.||
1748|131|B|||
1748|132|A|Information last revised February 2025.||
1748|133|A|Copyright(c) 2025 First Databank, Inc.||
1748|134|B|||
1749|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1749|002|Z|does NOT have all possible information about this product. This||
1749|003|Z|information does not assure that this product is safe, effective,||
1749|004|Z|or appropriate for you. This information is not individual||
1749|005|Z|medical advice and does not substitute for the advice of your||
1749|006|Z|health care professional. Always ask your health care||
1749|007|Z|professional for complete information about this product and your||
1749|008|Z|specific health needs.||
1749|009|B|||
1749|010|T|CARIPRAZINE - ORAL||
1749|011|F|(kar-IP-ra-zeen)||
1749|012|B|||
1749|013|C|COMMON BRAND NAME(S): Vraylar||
1749|014|B|||
1749|015|W|WARNING:  There may be a slightly increased risk of serious,||
1749|016|W|possibly fatal side effects (such as stroke, heart failure,||
1749|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1749|018|W|by older adults with dementia. This medication is not approved||
1749|019|W|for the treatment of dementia-related behavior problems. Discuss||
1749|020|W|the risks and benefits of this medication, as well as other||
1749|021|W|effective and possibly safer treatments for dementia-related||
1749|022|W|behavior problems, with the doctor.||
1749|023|W|   Studies have shown that a small number of people (especially||
1749|024|W|people younger than 25) who take antidepressants may have an||
1749|025|W|increased risk of suicidal thoughts or behaviors. Tell the doctor||
1749|026|W|right away if you notice worsening depression/other psychiatric||
1749|027|W|conditions, unusual behavior changes (including possible suicidal||
1749|028|W|thoughts/attempts), or other mental/mood changes (including||
1749|029|W|new/worsening anxiety, panic attacks, trouble sleeping,||
1749|030|W|irritability, hostile/angry feelings, impulsive actions, severe||
1749|031|W|restlessness, very rapid speech). Be especially watchful for||
1749|032|W|these symptoms when a new antidepressant is started or when the||
1749|033|W|dose is changed.||
1749|034|B|||
1749|035|U|USES:  This medication is used to treat certain mental/mood||
1749|036|U|disorders (such as bipolar disorder, depression, schizophrenia).||
1749|037|U|Cariprazine belongs to a class of drugs known as atypical||
1749|038|U|antipsychotics. It works by helping to restore the balance of||
1749|039|U|certain natural substances in the brain.||
1749|040|B|||
1749|041|H|HOW TO USE:  Read the Medication Guide provided by your||
1749|042|H|pharmacist before you start taking cariprazine and each time you||
1749|043|H|get a refill. If you have any questions, ask your doctor or||
1749|044|H|pharmacist.||
1749|045|H|   Take this medication by mouth with or without food as directed||
1749|046|H|by your doctor, usually once daily.||
1749|047|H|   The dosage is based on your medical condition, response to||
1749|048|H|treatment, and other medications you may be taking. Be sure to||
1749|049|H|tell your doctor and pharmacist about all the products you use||
1749|050|H|(including prescription drugs, nonprescription drugs, and herbal||
1749|051|H|products).||
1749|052|H|   To reduce your risk of side effects, your doctor may direct||
1749|053|H|you to start this medication at a low dose and gradually increase||
1749|054|H|your dose. Follow your doctor's instructions carefully.||
1749|055|H|   Use this medication regularly to get the most benefit from it.||
1749|056|H|To help you remember, take it at the same time each day.||
1749|057|H|   Do not increase your dose or use this drug more often or for||
1749|058|H|longer than prescribed. Your condition will not improve any||
1749|059|H|faster, and your risk of side effects will increase.||
1749|060|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1749|061|H|using this medication unless your doctor or pharmacist says you||
1749|062|H|may do so safely. Grapefruit can increase the chance of side||
1749|063|H|effects with this medicine. Ask your doctor or pharmacist for||
1749|064|H|more details.||
1749|065|H|   Tell your doctor if your condition does not get better or if||
1749|066|H|it gets worse.||
1749|067|B|||
1749|068|S|SIDE EFFECTS:  See also Warning section.||
1749|069|S|   Dizziness, lightheadedness, drowsiness, nausea, tiredness,||
1749|070|S|excess saliva/drooling, blurred vision, weight gain, or||
1749|071|S|constipation may occur. If any of these effects last or get||
1749|072|S|worse, tell your doctor or pharmacist promptly.||
1749|073|S|   Dizziness and lightheadedness can increase the risk of||
1749|074|S|falling. Get up slowly when rising from a sitting or lying||
1749|075|S|position.||
1749|076|S|   Remember that this medication has been prescribed because your||
1749|077|S|doctor has judged that the benefit to you is greater than the||
1749|078|S|risk of side effects. Many people using this medication do not||
1749|079|S|have serious side effects.||
1749|080|S|   Tell your doctor right away if you have any serious side||
1749|081|S|effects, such as: fainting, trouble swallowing, restlessness||
1749|082|S|(especially in the legs), shaking (tremor), muscle spasm,||
1749|083|S|mask-like expression of the face, seizures, signs of infection||
1749|084|S|(such as sore throat that doesn't go away, fever, chills).||
1749|085|S|   This medication may rarely make your blood sugar rise, which||
1749|086|S|can cause or worsen diabetes. Tell your doctor right away if you||
1749|087|S|have symptoms of high blood sugar such as increased||
1749|088|S|thirst/urination. If you already have diabetes, check your blood||
1749|089|S|sugar regularly as directed and share the results with your||
1749|090|S|doctor. Your doctor may need to adjust your diabetes medication,||
1749|091|S|exercise program, or diet.||
1749|092|S|   This medication may rarely cause a condition called tardive||
1749|093|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1749|094|S|your doctor right away if you develop any unusual uncontrolled||
1749|095|S|movements (especially of the face, mouth, tongue, arms, or legs).||
1749|096|S|   This medication may rarely cause a very serious condition||
1749|097|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1749|098|S|right away if you have any of the following symptoms: fever,||
1749|099|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1749|100|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1749|101|S|signs of kidney problems (such as change in the amount of urine).||
1749|102|S|   A very serious allergic reaction to this drug is rare.||
1749|103|S|However, get medical help right away if you notice any symptoms||
1749|104|S|of a serious allergic reaction, such as: rash, itching/swelling||
1749|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1749|106|S|breathing.||
1749|107|S|   This is not a complete list of possible side effects. If you||
1749|108|S|notice other effects not listed above, contact your doctor or||
1749|109|S|pharmacist.||
1749|110|S|   In the US -||
1749|111|S|   Call your doctor for medical advice about side effects. You||
1749|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1749|113|S|www.fda.gov/medwatch.||
1749|114|S|   In Canada - Call your doctor for medical advice about side||
1749|115|S|effects. You may report side effects to Health Canada at||
1749|116|S|1-866-234-2345.||
1749|117|B|||
1749|118|P|PRECAUTIONS:  See also Warning section.||
1749|119|P|   Before taking cariprazine, tell your doctor or pharmacist if||
1749|120|P|you are allergic to it; or if you have any other allergies. This||
1749|121|P|product may contain inactive ingredients, which can cause||
1749|122|P|allergic reactions or other problems. Talk to your pharmacist for||
1749|123|P|more details.||
1749|124|P|   Before using this medication, tell your doctor or pharmacist||
1749|125|P|your medical history, especially of: poor blood flow to the brain||
1749|126|P|(such as cerebrovascular disease, stroke), diabetes (including||
1749|127|P|family history), heart problems (such as heart failure, irregular||
1749|128|P|heartbeat), dehydration, high blood pressure, nervous system||
1749|129|P|problems (such as dementia, NMS, seizures), obesity, low white||
1749|130|P|blood cell count (such as history of low white blood cell count||
1749|131|P|caused by medications), swallowing problems.||
1749|132|P|   This drug may make you dizzy or drowsy or blur your vision.||
1749|133|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1749|134|P|drowsy. Do not drive, use machinery, or do anything that needs||
1749|135|P|alertness or clear vision until you can do it safely. Limit||
1749|136|P|alcoholic beverages. Talk to your doctor if you are using||
1749|137|P|marijuana (cannabis).||
1749|138|P|   Cariprazine may make you sweat less, making you more likely to||
1749|139|P|get heat stroke. Avoid doing things that may cause you to||
1749|140|P|overheat, such as hard work or exercise in hot weather, or using||
1749|141|P|hot tubs. When the weather is hot, drink a lot of fluids and||
1749|142|P|dress lightly. If you overheat, quickly look for a place to cool||
1749|143|P|down and rest. Get medical help right away if you have a fever||
1749|144|P|that does not go away, mental/mood changes, headache, or||
1749|145|P|dizziness.||
1749|146|P|   Older adults may be more sensitive to the side effects of this||
1749|147|P|drug, especially seizures, drowsiness, dizziness,||
1749|148|P|lightheadedness, confusion, tardive dyskinesia, swallowing||
1749|149|P|problems, and other serious (rarely fatal) side effects. See also||
1749|150|P|Warning section. Drowsiness, dizziness, lightheadedness, and||
1749|151|P|confusion can increase the risk of falling.||
1749|152|P|   Before having surgery, tell your doctor or dentist about all||
1749|153|P|the products you use (such as prescription drugs, nonprescription||
1749|154|P|drugs, and herbal products).||
1749|155|P|   During pregnancy, this medication should be used only when||
1749|156|P|clearly needed. It may harm an unborn baby. Babies born to||
1749|157|P|mothers who have used this drug during the last 3 months of||
1749|158|P|pregnancy may rarely develop symptoms including muscle stiffness||
1749|159|P|or shakiness, drowsiness, feeding/breathing difficulties, or||
1749|160|P|constant crying. If you notice any of these symptoms in your||
1749|161|P|newborn especially during their first month, tell the doctor||
1749|162|P|right away.||
1749|163|P|   Since untreated mental/mood problems (such as bipolar||
1749|164|P|disorder, schizophrenia) can be a serious condition, do not stop||
1749|165|P|taking this medication unless directed by your doctor. If you are||
1749|166|P|planning pregnancy, become pregnant, or think you may be||
1749|167|P|pregnant, discuss with your doctor right away the benefits and||
1749|168|P|risks of using this medication during pregnancy.||
1749|169|P|   It is unknown if this medication passes into breast milk.||
1749|170|P|Consult your doctor before breastfeeding.||
1749|171|B|||
1749|172|I|DRUG INTERACTIONS:  See also How to Use section.||
1749|173|I|   Drug interactions may change how your medications work or||
1749|174|I|increase your risk for serious side effects. This document does||
1749|175|I|not contain all possible drug interactions. Keep a list of all||
1749|176|I|the products you use (such as prescription/nonprescription drugs||
1749|177|I|and herbal products) and share it with your doctor and||
1749|178|I|pharmacist. Do not start, stop, or change the dosage of any||
1749|179|I|medicines without your doctor's approval.||
1749|180|I|   A product that may interact with this drug is: metoclopramide.||
1749|181|B|||
1749|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1749|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1749|184|O|poison control center right away. US residents can call||
1749|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1749|186|B|||
1749|187|N|NOTES:  Do not share this medication with others.||
1749|188|N|   Lab and/or medical tests (such as blood sugar, weight,||
1749|189|N|cholesterol/triglyceride levels) may be done before you start||
1749|190|N|taking this medication and while you are taking it. Keep all||
1749|191|N|medical and lab appointments. Consult your doctor for more||
1749|192|N|details.||
1749|193|B|||
1749|194|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1749|195|D|remember. If it is near the time of the next dose, skip the||
1749|196|D|missed dose. Take your next dose at the regular time. Do not||
1749|197|D|double the dose to catch up.||
1749|198|B|||
1749|199|R|STORAGE:  Store at room temperature away from light and moisture.||
1749|200|R|Do not store in the bathroom. Keep all medications away from||
1749|201|R|children and pets.||
1749|202|R|   Do not flush medications down the toilet or pour them into a||
1749|203|R|drain unless instructed to do so. Properly discard this product||
1749|204|R|when it is expired or no longer needed. Consult your pharmacist||
1749|205|R|or local waste disposal company.||
1749|206|B|||
1749|207|A|Information last revised April 2025.||
1749|208|A|Copyright(c) 2025 First Databank, Inc.||
1749|209|B|||
1750|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1750|002|Z|does NOT have all possible information about this product. This||
1750|003|Z|information does not assure that this product is safe, effective,||
1750|004|Z|or appropriate for you. This information is not individual||
1750|005|Z|medical advice and does not substitute for the advice of your||
1750|006|Z|health care professional. Always ask your health care||
1750|007|Z|professional for complete information about this product and your||
1750|008|Z|specific health needs.||
1750|009|B|||
1750|010|T|LEVETIRACETAM TABLET - FOR ORAL SUSPENSION||
1750|011|F|(LEE-ve-tye-RA-se-tam)||
1750|012|B|||
1750|013|C|COMMON BRAND NAME(S): Spritam||
1750|014|B|||
1750|015|U|USES:  Levetiracetam is used with other medications to treat||
1750|016|U|seizures (epilepsy). It belongs to a class of drugs known as||
1750|017|U|anticonvulsants. Levetiracetam may decrease the number of||
1750|018|U|seizures you have.||
1750|019|B|||
1750|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1750|021|H|pharmacist before you start taking levetiracetam and each time||
1750|022|H|you get a refill. If you have any questions, ask your doctor or||
1750|023|H|pharmacist.||
1750|024|H|   Take this medication by mouth with or without food as directed||
1750|025|H|by your doctor, usually twice a day.||
1750|026|H|   Carefully remove the tablet(s) from the foil packet as||
1750|027|H|directed by the product package. Do not push the tablet(s)||
1750|028|H|through the foil. Dry your hands before handling the medication.||
1750|029|H|Place each dose on the tongue and take a sip of liquid. Allow the||
1750|030|H|medication to completely dissolve before swallowing it. Do not||
1750|031|H|swallow the tablet(s) whole.||
1750|032|H|   The tablet(s) may also be placed in a cup with a small amount||
1750|033|H|of liquid (1 tablespoon/15 milliliters). Swirl the mixture||
1750|034|H|gently, then drink all of the mixture right away. To make sure||
1750|035|H|you have taken all of the medication, add another small amount of||
1750|036|H|liquid to the cup to rinse it, and drink it right away.||
1750|037|H|   If you are giving this medication through a feeding tube, ask||
1750|038|H|your health care professional for detailed instructions on how to||
1750|039|H|properly mix and give it.||
1750|040|H|   The dosage is based on your medical condition and response to||
1750|041|H|treatment. Children's dosage is also based on weight. To reduce||
1750|042|H|your risk of side effects (such as dizziness and drowsiness),||
1750|043|H|your doctor may direct you to start this medication at a low dose||
1750|044|H|and gradually increase your dose. Follow your doctor's||
1750|045|H|instructions carefully.||
1750|046|H|   Use this medication regularly to get the most benefit from it.||
1750|047|H|To help you remember, take it at the same times each day.||
1750|048|H|   Do not increase your dose or use this drug more often or for||
1750|049|H|longer than prescribed. Your condition will not improve any||
1750|050|H|faster, and your risk of side effects will increase.||
1750|051|H|   Do not stop taking this medication without consulting your||
1750|052|H|doctor. Your seizures may become worse when the drug is suddenly||
1750|053|H|stopped. Your dose should be gradually decreased.||
1750|054|H|   Tell your doctor if your seizures lasts, change, or gets||
1750|055|H|worse.||
1750|056|B|||
1750|057|S|SIDE EFFECTS:  Drowsiness, dizziness, unusual tiredness, or||
1750|058|S|weakness may occur. These side effects are more common during the||
1750|059|S|first 4 weeks and usually lessen as your body adjusts to the||
1750|060|S|medication. If any of these effects last or get worse, tell your||
1750|061|S|doctor or pharmacist promptly.||
1750|062|S|   Remember that this medication has been prescribed because your||
1750|063|S|doctor has judged that the benefit to you is greater than the||
1750|064|S|risk of side effects. Many people using this medication do not||
1750|065|S|have serious side effects.||
1750|066|S|   Tell your doctor right away if you have any serious side||
1750|067|S|effects, such as: loss of coordination (such as difficulty||
1750|068|S|walking and controlling muscles), mental/mood changes (such as||
1750|069|S|irritability, aggression, agitation, anger, anxiety), signs of||
1750|070|S|anemia (such as unusual tiredness that doesn't go away, pale||
1750|071|S|skin, fast breathing, fast heartbeat), easy bruising/bleeding.||
1750|072|S|   A small number of people who take anticonvulsants for any||
1750|073|S|condition (such as seizures, bipolar disorder, pain) may||
1750|074|S|experience depression, suicidal thoughts/attempts, or other||
1750|075|S|mental/mood problems. Tell your doctor right away if you or your||
1750|076|S|family/caregiver notice any unusual/sudden changes in your mood,||
1750|077|S|thoughts, or behavior including signs of depression, suicidal||
1750|078|S|thoughts/attempts, thoughts about harming yourself.||
1750|079|S|   Levetiracetam can commonly cause a rash that is usually not||
1750|080|S|serious. However, you may not be able to tell it apart from a||
1750|081|S|rare rash that could be a sign of a severe reaction. Tell your||
1750|082|S|doctor right away if you develop any rash.||
1750|083|S|   A very serious allergic reaction to this drug is rare.||
1750|084|S|However, get medical help right away if you notice any symptoms||
1750|085|S|of a serious allergic reaction, such as: fever, swollen lymph||
1750|086|S|nodes, rash, itching/swelling (especially of the||
1750|087|S|face/tongue/throat), severe dizziness, trouble breathing.||
1750|088|S|   This is not a complete list of possible side effects. If you||
1750|089|S|notice other effects not listed above, contact your doctor or||
1750|090|S|pharmacist.||
1750|091|S|   In the US -||
1750|092|S|   Call your doctor for medical advice about side effects. You||
1750|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1750|094|S|www.fda.gov/medwatch.||
1750|095|S|   In Canada - Call your doctor for medical advice about side||
1750|096|S|effects. You may report side effects to Health Canada at||
1750|097|S|1-866-234-2345.||
1750|098|B|||
1750|099|P|PRECAUTIONS:  Before taking levetiracetam, tell your doctor or||
1750|100|P|pharmacist if you are allergic to it; or if you have any other||
1750|101|P|allergies. This product may contain inactive ingredients, which||
1750|102|P|can cause allergic reactions or other problems. Talk to your||
1750|103|P|pharmacist for more details.||
1750|104|P|   Before using this medication, tell your doctor or pharmacist||
1750|105|P|your medical history, especially of: kidney disease (such as||
1750|106|P|dialysis treatment), mental/mood disorders (such as depression).||
1750|107|P|   This drug may make you dizzy or drowsy, especially during the||
1750|108|P|first month of treatment. Alcohol or marijuana (cannabis) can||
1750|109|P|make you more dizzy or drowsy. Do not drive, use machinery, ride||
1750|110|P|a bicycle, or do anything that needs alertness until you can do||
1750|111|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1750|112|P|are using marijuana (cannabis).||
1750|113|P|   Before having surgery, tell your doctor or dentist about all||
1750|114|P|the products you use (such as prescription drugs, nonprescription||
1750|115|P|drugs, and herbal products).||
1750|116|P|   Children may be more sensitive to the side effects of the||
1750|117|P|drug, especially mental/mood changes (such as irritability,||
1750|118|P|aggression, agitation, anger, anxiety, depression, thoughts of||
1750|119|P|suicide). Children younger than 4 years may be at greater risk||
1750|120|P|for increased blood pressure while using this drug (see also||
1750|121|P|Notes section).||
1750|122|P|   Older adults may be more sensitive to the side effects of this||
1750|123|P|drug, especially drowsiness, dizziness or loss of coordination.||
1750|124|P|These side effects can increase the risk of falling.||
1750|125|P|   During pregnancy, this medication should be used only when||
1750|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
1750|127|P|   This medication passes into breast milk. Consult your doctor||
1750|128|P|before breastfeeding.||
1750|129|B|||
1750|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1750|131|I|medications work or increase your risk for serious side effects.||
1750|132|I|This document does not contain all possible drug interactions.||
1750|133|I|Keep a list of all the products you use (including||
1750|134|I|prescription/nonprescription drugs and herbal products) and share||
1750|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
1750|136|I|the dosage of any medicines without your doctor's approval.||
1750|137|I|   A product that may interact with this drug is: orlistat.||
1750|138|B|||
1750|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1750|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1750|141|O|poison control center right away. US residents can call||
1750|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1750|143|O|Symptoms of overdose may include: slow/shallow breathing, loss of||
1750|144|O|consciousness.||
1750|145|B|||
1750|146|N|NOTES:  Do not share this medication with others.||
1750|147|N|   Lab and/or medical tests (such as kidney function, complete||
1750|148|N|blood count) may be done while you are taking this medication. In||
1750|149|N|children younger than 4 years, blood pressure may also be||
1750|150|N|monitored. Consult your doctor for more details.||
1750|151|B|||
1750|152|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1750|153|D|remember. If it is near the time of the next dose, skip the||
1750|154|D|missed dose. Take your next dose at the regular time. Do not||
1750|155|D|double the dose to catch up.||
1750|156|B|||
1750|157|R|STORAGE:  Store at room temperature away from light and moisture.||
1750|158|R|Do not store in the bathroom. Keep all medications away from||
1750|159|R|children and pets.||
1750|160|R|   Do not flush medications down the toilet or pour them into a||
1750|161|R|drain unless instructed to do so. Properly discard this product||
1750|162|R|when it is expired or no longer needed. Consult your pharmacist||
1750|163|R|or local waste disposal company.||
1750|164|B|||
1750|165|M|MEDICAL ALERT:  Your condition can cause complications in a||
1750|166|M|medical emergency. For information about enrolling in MedicAlert,||
1750|167|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1750|168|B|||
1750|169|A|Information last revised June 2025.||
1750|170|A|Copyright(c) 2025 First Databank, Inc.||
1750|171|B|||
1751|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1751|002|Z|does NOT have all possible information about this product. This||
1751|003|Z|information does not assure that this product is safe, effective,||
1751|004|Z|or appropriate for you. This information is not individual||
1751|005|Z|medical advice and does not substitute for the advice of your||
1751|006|Z|health care professional. Always ask your health care||
1751|007|Z|professional for complete information about this product and your||
1751|008|Z|specific health needs.||
1751|009|B|||
1751|010|T|DAPAGLIFLOZIN/METFORMIN - ORAL||
1751|011|F|(DAP-a-gli-FLOE-zin/met-FOR-min)||
1751|012|B|||
1751|013|W|WARNING:  Rarely, too much metformin can build up in the body and||
1751|014|W|cause a serious (sometimes fatal) condition called lactic||
1751|015|W|acidosis. Lactic acidosis is more likely if you are an older||
1751|016|W|adult, if you have kidney or liver disease, dehydration, heart||
1751|017|W|failure, heavy alcohol use, if you have surgery, if you have||
1751|018|W|X-ray or scanning procedures that use iodinated contrast, or if||
1751|019|W|you are using certain drugs. For some conditions, your doctor may||
1751|020|W|tell you to stop taking this medication for a short time. Ask||
1751|021|W|your doctor or pharmacist for more details.||
1751|022|W|   Stop taking this medication and get medical help right away if||
1751|023|W|you have any symptoms of lactic acidosis, such as unusual||
1751|024|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1751|025|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1751|026|W|or stomach pain with nausea/vomiting/diarrhea.||
1751|027|B|||
1751|028|U|USES:  This medication is a combination of 2 drugs: dapagliflozin||
1751|029|U|and metformin. It is used with a proper diet and exercise program||
1751|030|U|to control high blood sugar in people with type 2 diabetes.||
1751|031|U|Controlling high blood sugar helps prevent kidney damage,||
1751|032|U|blindness, nerve problems, loss of limbs, and sexual function||
1751|033|U|problems. Proper control of diabetes may also lessen your risk of||
1751|034|U|a heart attack or stroke. This medication works by helping to||
1751|035|U|restore your body's proper response to the insulin you naturally||
1751|036|U|produce. It also increases the removal of sugar by your kidneys,||
1751|037|U|decreases how much sugar is made in your liver, and decreases how||
1751|038|U|much sugar your body takes in through your stomach and||
1751|039|U|intestines.||
1751|040|B|||
1751|041|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1751|042|H|from your pharmacist before you start taking this medication and||
1751|043|H|each time you get a refill. If you have any questions, ask your||
1751|044|H|doctor or pharmacist.||
1751|045|H|   Take this medication by mouth as directed by your doctor,||
1751|046|H|usually 2 times a day with a meal.||
1751|047|H|   The dosage is based on your medical condition, response to||
1751|048|H|treatment, and other medications you may be taking. Be sure to||
1751|049|H|tell your doctor and pharmacist about all the products you use||
1751|050|H|(including prescription drugs, nonprescription drugs, and herbal||
1751|051|H|products).||
1751|052|H|   Take this medication regularly to get the most benefit from||
1751|053|H|it. To help you remember, take it at the same times each day.||
1751|054|H|   Tell your doctor if your condition does not get better or if||
1751|055|H|it gets worse (your blood sugar is too high or too low).||
1751|056|B|||
1751|057|S|SIDE EFFECTS:  See also Warning section.||
1751|058|S|   Headache, diarrhea, nausea, vomiting, bloating/gas, runny||
1751|059|S|nose, or sore throat may occur. If any of these effects last or||
1751|060|S|get worse, tell your doctor or pharmacist promptly. If stomach||
1751|061|S|symptoms return later (after taking the same dose for several||
1751|062|S|days or weeks), tell your doctor right away. Stomach symptoms||
1751|063|S|that occur after the first days of your treatment may be signs of||
1751|064|S|lactic acidosis.||
1751|065|S|   Remember that this medication has been prescribed because your||
1751|066|S|doctor has judged that the benefit to you is greater than the||
1751|067|S|risk of side effects. Many people using this medication do not||
1751|068|S|have serious side effects.||
1751|069|S|   Tell your doctor right away if you have any serious side||
1751|070|S|effects, including: signs of a urinary tract infection (such as||
1751|071|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1751|072|S|signs of kidney problems (such as change in the amount of urine,||
1751|073|S|swelling legs/feet).||
1751|074|S|   This medication may cause a new yeast infection in the vagina||
1751|075|S|or the penis. It may also cause a rare but very serious bacterial||
1751|076|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1751|077|S|your doctor right away if you have signs of a yeast infection in||
1751|078|S|the vagina (such as unusual vaginal||
1751|079|S|discharge/burning/itching/odor) or in the penis (such as||
1751|080|S|redness/itching/swelling of the penis, unusual discharge from the||
1751|081|S|penis). However, get medical help right away if you have any||
1751|082|S|pain/redness/swelling in or around the genital/anal area, along||
1751|083|S|with a fever or feeling unwell.||
1751|084|S|   This medication does not usually cause low blood sugar||
1751|085|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1751|086|S|prescribed with other diabetes medications, or if you do not get||
1751|087|S|enough calories from food, or if you do unusually heavy exercise.||
1751|088|S|Talk with your doctor or pharmacist about whether the dose of||
1751|089|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1751|090|S|of low blood sugar include sudden sweating, shaking, fast||
1751|091|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1751|092|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1751|093|S|treat low blood sugar. If you don't have these reliable forms of||
1751|094|S|glucose, rapidly raise your blood sugar by eating a quick source||
1751|095|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1751|096|S|juice or non-diet soda. Tell your doctor right away about the||
1751|097|S|reaction and the use of this product. To help prevent low blood||
1751|098|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1751|099|S|Check with your doctor or pharmacist to find out what you should||
1751|100|S|do if you miss a meal.||
1751|101|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1751|102|S|thirst/urination. If these symptoms occur, tell your doctor right||
1751|103|S|away. Your doctor may need to adjust your diabetes medication,||
1751|104|S|exercise program, or diet.||
1751|105|S|   This medication may cause you to become dehydrated. This can||
1751|106|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1751|107|S|dehydration. Tell your doctor or pharmacist right away if you are||
1751|108|S|not able to drink fluids as usual, or losing fluid (such as due||
1751|109|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1751|110|S|right away if you have any signs of dehydration, such as||
1751|111|S|urinating less than usual, unusual dry mouth/thirst, fast||
1751|112|S|heartbeat, or dizziness/lightheadedness/fainting. To reduce the||
1751|113|S|risk of dizziness and lightheadedness, get up slowly when rising||
1751|114|S|from a sitting or lying position.||
1751|115|S|   A very serious allergic reaction to this drug is rare.||
1751|116|S|However, get medical help right away if you notice any symptoms||
1751|117|S|of a serious allergic reaction, including: rash, itching/swelling||
1751|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1751|119|S|breathing.||
1751|120|S|   This is not a complete list of possible side effects. If you||
1751|121|S|notice other effects not listed above, contact your doctor or||
1751|122|S|pharmacist.||
1751|123|S|   In the US -||
1751|124|S|   Call your doctor for medical advice about side effects. You||
1751|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1751|126|S|www.fda.gov/medwatch.||
1751|127|S|   In Canada - Call your doctor for medical advice about side||
1751|128|S|effects. You may report side effects to Health Canada at||
1751|129|S|1-866-234-2345.||
1751|130|B|||
1751|131|P|PRECAUTIONS:  See also Warning section.||
1751|132|P|   Before taking this medication, tell your doctor or pharmacist||
1751|133|P|if you are allergic to dapagliflozin or metformin; or if you have||
1751|134|P|any other allergies. This product may contain inactive||
1751|135|P|ingredients, which can cause allergic reactions or other||
1751|136|P|problems. Talk to your pharmacist for more details.||
1751|137|P|   Before using this medication, tell your doctor or pharmacist||
1751|138|P|your medical history, especially of: blood problems (such as||
1751|139|P|anemia, vitamin B12 deficiency), breathing problems (such as||
1751|140|P|asthma, obstructive lung disease), heart disease (such as heart||
1751|141|P|failure, recent heart attack), kidney disease, liver disease,||
1751|142|P|disease of the pancreas (pancreatitis), dehydration, use/abuse of||
1751|143|P|alcohol, yeast infections in the vagina or penis.||
1751|144|P|   You may experience blurred vision, dizziness, or drowsiness||
1751|145|P|due to extremely low or high blood sugar. Do not drive, use||
1751|146|P|machinery, or do anything that needs alertness or clear vision||
1751|147|P|until you can do it safely.||
1751|148|P|   Limit alcohol while taking this medication because it can||
1751|149|P|increase your risk of developing lactic acidosis, low blood||
1751|150|P|sugar, and a high ketone level.||
1751|151|P|   High fever, "water pills" (diuretics such as||
1751|152|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1751|153|P|may cause dehydration and increase your risk of lactic acidosis.||
1751|154|P|Stop taking this medication and tell your doctor right away if||
1751|155|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1751|156|P|fluids to prevent dehydration unless your doctor directs you||
1751|157|P|otherwise.||
1751|158|P|   It may be harder to control your blood sugar when your body is||
1751|159|P|stressed (such as due to fever, infection, injury, or surgery).||
1751|160|P|Also, if you are eating less or not able to eat due to these||
1751|161|P|conditions or any illness, this can lead to a high ketone level||
1751|162|P|while you are taking this medication. Consult your doctor because||
1751|163|P|this may require a change in your treatment plan, medications, or||
1751|164|P|blood sugar or ketone testing.||
1751|165|P|   Before having surgery or any X-ray/scanning procedure using||
1751|166|P|iodinated contrast, tell your doctor or dentist about all the||
1751|167|P|products you use (including prescription drugs, nonprescription||
1751|168|P|drugs, and herbal products). You may need to stop this medication||
1751|169|P|for a short time for the surgery/procedure. Ask your doctor or||
1751|170|P|dentist for instructions before your surgery/procedure.||
1751|171|P|   Older adults may be more sensitive to the side effects of this||
1751|172|P|drug, especially low blood sugar, dehydration, lactic acidosis,||
1751|173|P|kidney problems, and low blood pressure.||
1751|174|P|   During pregnancy, this medication should be used only when||
1751|175|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1751|176|P|benefits with your doctor.||
1751|177|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1751|178|P|your doctor for managing your blood sugar while pregnant. Your||
1751|179|P|doctor may change your diabetes treatment during your pregnancy||
1751|180|P|(such as diet and medications including insulin).||
1751|181|P|   Metformin can cause changes in the menstrual cycle (promote||
1751|182|P|ovulation) and increase the risk of becoming pregnant. Consult||
1751|183|P|your doctor or pharmacist about the use of reliable birth control||
1751|184|P|while using this medication.||
1751|185|P|   Metformin passes into breast milk in small amounts. It is||
1751|186|P|unknown if dapagliflozin passes into breast milk. Consult your||
1751|187|P|doctor before breastfeeding.||
1751|188|B|||
1751|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1751|190|I|medications work or increase your risk for serious side effects.||
1751|191|I|This document does not contain all possible drug interactions.||
1751|192|I|Keep a list of all the products you use (including||
1751|193|I|prescription/nonprescription drugs and herbal products) and share||
1751|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
1751|195|I|the dosage of any medicines without your doctor's approval.||
1751|196|I|   Many drugs can affect your blood sugar, making it harder to||
1751|197|I|control. Before you start, stop, or change any medication, talk||
1751|198|I|with your doctor or pharmacist about how the medication may||
1751|199|I|affect your blood sugar. Check your blood sugar regularly as||
1751|200|I|directed and share the results with your doctor. Tell your doctor||
1751|201|I|right away if you have symptoms of high or low blood sugar. (See||
1751|202|I|also Side Effects section.) Your doctor may need to adjust your||
1751|203|I|diabetes medication, exercise program, or diet.||
1751|204|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1751|205|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1751|206|I|heartbeat you would usually feel when your blood sugar falls too||
1751|207|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1751|208|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1751|209|I|   Your urine will test positive for glucose. Make sure lab||
1751|210|I|personnel and all your doctors know you use this drug.||
1751|211|B|||
1751|212|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1751|213|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1751|214|O|poison control center right away. US residents can call||
1751|215|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1751|216|O|Overdose can lead to lactic acidosis. Symptoms of overdose may||
1751|217|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
1751|218|O|rapid breathing, slow/irregular heartbeat.||
1751|219|B|||
1751|220|N|NOTES:  Do not share this medication with others.||
1751|221|N|   Attend a diabetes education program to learn more about how to||
1751|222|N|manage your diabetes with medications, diet, exercise, and||
1751|223|N|regular medical exams.||
1751|224|N|   Learn the symptoms of high and low blood sugar and how to||
1751|225|N|treat low blood sugar. Check your blood sugar regularly as||
1751|226|N|directed.||
1751|227|N|   Lab and/or medical tests (such as kidney function, liver||
1751|228|N|function, blood sugar, hemoglobin A1c, ketones, complete blood||
1751|229|N|counts, cholesterol, vitamin B12) should be done before you start||
1751|230|N|taking this medication and while you are taking it. Keep all||
1751|231|N|medical and lab appointments. Consult your doctor for more||
1751|232|N|details.||
1751|233|B|||
1751|234|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1751|235|D|remember. If it is near the time of the next dose, skip the||
1751|236|D|missed dose. Take your next dose at the regular time. Do not||
1751|237|D|double the dose to catch up.||
1751|238|B|||
1751|239|R|STORAGE:  Store at room temperature away from light and moisture.||
1751|240|R|Do not store in the bathroom. Keep all medications away from||
1751|241|R|children and pets.||
1751|242|R|   Do not flush medications down the toilet or pour them into a||
1751|243|R|drain unless instructed to do so. Properly discard this product||
1751|244|R|when it is expired or no longer needed. Consult your pharmacist||
1751|245|R|or local waste disposal company.||
1751|246|B|||
1751|247|M|MEDICAL ALERT:  Your condition can cause complications in a||
1751|248|M|medical emergency. For information about enrolling in MedicAlert,||
1751|249|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1751|250|B|||
1751|251|A|Information last revised May 2025.||
1751|252|A|Copyright(c) 2025 First Databank, Inc.||
1751|253|B|||
1752|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1752|002|Z|does NOT have all possible information about this product. This||
1752|003|Z|information does not assure that this product is safe, effective,||
1752|004|Z|or appropriate for you. This information is not individual||
1752|005|Z|medical advice and does not substitute for the advice of your||
1752|006|Z|health care professional. Always ask your health care||
1752|007|Z|professional for complete information about this product and your||
1752|008|Z|specific health needs.||
1752|009|B|||
1752|010|T|TOFACITINIB EXTENDED-RELEASE - ORAL||
1752|011|F|(TOE-fa-SYE-ti-nib)||
1752|012|B|||
1752|013|C|COMMON BRAND NAME(S): Xeljanz XR||
1752|014|B|||
1752|015|W|WARNING:  Tofacitinib may lower your ability to fight infections.||
1752|016|W|This may make you more likely to get a serious (rarely fatal)||
1752|017|W|infection or make any infection you have worse. The most common||
1752|018|W|serious infections include pneumonia, skin infections, shingles,||
1752|019|W|a certain bowel disease (diverticulitis), swelling of the||
1752|020|W|appendix (appendicitis), and urinary tract infections. The risk||
1752|021|W|for infections may be higher if you also take other drugs that||
1752|022|W|suppress the immune system (such as cyclosporine, tacrolimus).||
1752|023|W|Tell your doctor right away if you have any signs of infection||
1752|024|W|(such as a sore throat that doesn't go away, fever, chills,||
1752|025|W|cough, trouble breathing, painful/frequent urination, non-healing||
1752|026|W|skin sores).||
1752|027|W|   You should have a tuberculosis (TB) skin test before and||
1752|028|W|during treatment with this medication. Tell your doctor if you||
1752|029|W|have been near someone with tuberculosis or have lived or||
1752|030|W|traveled in areas where certain fungal infections (such as||
1752|031|W|coccidioidomycosis, histoplasmosis) are common. These areas||
1752|032|W|include the Ohio and Mississippi River valleys and the||
1752|033|W|southwestern United States.||
1752|034|W|   Though it is very unlikely to occur, there may be a risk of||
1752|035|W|developing cancer (such as lymphoma, skin cancer, lung cancer)||
1752|036|W|with this medication. Your risk may be higher if you are a||
1752|037|W|current or past smoker. Tell your doctor right away if you||
1752|038|W|develop symptoms such as fever or cough that doesn't go away,||
1752|039|W|wheezing, unusual lumps/growths, unexplained weight loss, night||
1752|040|W|sweats, change in appearance or size of moles, or unusual skin||
1752|041|W|changes.||
1752|042|W|   Tofacitinib may cause serious (possibly fatal) problems from||
1752|043|W|blood clots (such as heart attack, stroke, blood clots in the||
1752|044|W|lungs or legs). You may be at an increased risk for blood clots||
1752|045|W|if you are a current or past smoker, or are 50 years of age or||
1752|046|W|older and have at least one risk factor for heart disease.||
1752|047|W|Discuss the risks and benefits of treatment with your doctor. Get||
1752|048|W|medical help right away if any of these side effects occur:||
1752|049|W|shortness of breath/rapid breathing, chest/jaw/left arm pain,||
1752|050|W|unusual sweating, confusion, sudden dizziness/fainting,||
1752|051|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1752|052|W|trouble speaking, weakness on one side of the body, or sudden||
1752|053|W|vision changes.||
1752|054|W|   People with a kidney transplant who are also taking other||
1752|055|W|drugs that suppress the immune system may be at greater risk for||
1752|056|W|developing a certain white blood cell disorder (Epstein Barr||
1752|057|W|Virus-associated post-transplant lymphoproliferative disorder)||
1752|058|W|with this medication. Discuss the risks and benefits of treatment||
1752|059|W|with your doctor.||
1752|060|B|||
1752|061|U|USES:  Tofacitinib is used to treat certain types of arthritis||
1752|062|U|(such as psoriatic arthritis, rheumatoid arthritis, ankylosing||
1752|063|U|spondylitis). It helps to decrease pain/tenderness/swelling in||
1752|064|U|the joints. Tofacitinib is also used to treat a certain bowel||
1752|065|U|disease (ulcerative colitis). It helps to reduce symptoms of||
1752|066|U|ulcerative colitis such as diarrhea, rectal bleeding, and stomach||
1752|067|U|pain.||
1752|068|B|||
1752|069|H|HOW TO USE:  Read the Medication Guide provided by your||
1752|070|H|pharmacist before you start taking tofacitinib and each time you||
1752|071|H|get a refill. If you have any questions, ask your doctor or||
1752|072|H|pharmacist.||
1752|073|H|   Take this medication by mouth with or without food as directed||
1752|074|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
1752|075|H|not crush, split, or chew the tablets. Doing so can release all||
1752|076|H|of the drug at once, increasing the risk of side effects.||
1752|077|H|   The dosage is based on your medical condition, response to||
1752|078|H|treatment, lab tests, and other medications you may be taking. Be||
1752|079|H|sure to tell your doctor and pharmacist about all the products||
1752|080|H|you use (including prescription drugs, nonprescription drugs, and||
1752|081|H|herbal products). Do not increase your dose or use this drug more||
1752|082|H|often or for longer than prescribed. Your condition will not||
1752|083|H|improve any faster, and your risk of serious side effects will||
1752|084|H|increase.||
1752|085|H|   Use this medication regularly to get the most benefit from it.||
1752|086|H|To help you remember, take it at the same time each day.||
1752|087|H|   Tell your doctor if your condition does not get better or if||
1752|088|H|it gets worse.||
1752|089|B|||
1752|090|S|SIDE EFFECTS:  See also Warning section.||
1752|091|S|   Headache or diarrhea may occur. If either of these effects||
1752|092|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
1752|093|S|   An empty tablet shell may appear in your stool. This effect is||
1752|094|S|harmless because your body has already absorbed the medication.||
1752|095|S|   People using this medication may have serious side effects.||
1752|096|S|However, you have been prescribed this drug because your doctor||
1752|097|S|has judged that the benefit to you is greater than the risk of||
1752|098|S|side effects. Careful monitoring by your doctor may decrease your||
1752|099|S|risk.||
1752|100|S|   Tell your doctor right away if you have any serious side||
1752|101|S|effects, such as: unusual tiredness, fast heartbeat, signs of||
1752|102|S|liver disease (such as nausea/vomiting that doesn't stop, loss of||
1752|103|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1752|104|S|urine).||
1752|105|S|   A very serious allergic reaction to this drug is rare.||
1752|106|S|However, get medical help right away if you notice any symptoms||
1752|107|S|of a serious allergic reaction, such as: rash, itching/swelling||
1752|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1752|109|S|breathing.||
1752|110|S|   This is not a complete list of possible side effects. If you||
1752|111|S|notice other effects not listed above, contact your doctor or||
1752|112|S|pharmacist.||
1752|113|S|   In the US -||
1752|114|S|   Call your doctor for medical advice about side effects. You||
1752|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1752|116|S|www.fda.gov/medwatch.||
1752|117|S|   In Canada - Call your doctor for medical advice about side||
1752|118|S|effects. You may report side effects to Health Canada at||
1752|119|S|1-866-234-2345.||
1752|120|B|||
1752|121|P|PRECAUTIONS:  See also Warning section.||
1752|122|P|   Before taking tofacitinib, tell your doctor or pharmacist if||
1752|123|P|you are allergic to it; or if you have any other allergies. This||
1752|124|P|product may contain inactive ingredients, which can cause||
1752|125|P|allergic reactions or other problems. Talk to your pharmacist for||
1752|126|P|more details.||
1752|127|P|   Before using this medication, tell your doctor or pharmacist||
1752|128|P|your medical history, especially of: blood clots (such as in the||
1752|129|P|lungs, legs), blood/bone marrow disorders (such as anemia, low||
1752|130|P|lymphocyte/neutrophil count), cancer, heart problems (such as||
1752|131|P|previous heart attack), kidney disease, liver disease (such as||
1752|132|P|hepatitis B or C), lung disease, past/recent/current infections||
1752|133|P|(such as tuberculosis, herpes zoster, HIV infection), current or||
1752|134|P|past smoking, other stomach/intestinal disorders (such as ulcers,||
1752|135|P|diverticulitis), stroke.||
1752|136|P|   Tofacitinib can make you more likely to get infections or may||
1752|137|P|make current infections worse. Stay away from anyone who has an||
1752|138|P|infection that may easily spread (such as chickenpox, COVID-19,||
1752|139|P|measles, flu). Talk to your doctor if you have been exposed to an||
1752|140|P|infection or for more details.||
1752|141|P|   Tell your health care professional that you are using||
1752|142|P|tofacitinib before having any immunizations/vaccinations. Avoid||
1752|143|P|contact with people who have recently received live vaccines||
1752|144|P|(such as flu vaccine inhaled through the nose).||
1752|145|P|   Before having surgery, tell your doctor or dentist about all||
1752|146|P|the products you use (including prescription drugs,||
1752|147|P|nonprescription drugs, and herbal products).||
1752|148|P|   Older adults may be at greater risk for infections while using||
1752|149|P|this drug.||
1752|150|P|   During pregnancy, this medication should be used only when||
1752|151|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1752|152|P|benefits with your doctor.||
1752|153|P|   This medication passes into breast milk. Because of the||
1752|154|P|possible risk to the infant, breastfeeding is not recommended||
1752|155|P|while using this medication and for at least 36 hours after the||
1752|156|P|last dose. Consult your doctor before breastfeeding.||
1752|157|B|||
1752|158|I|DRUG INTERACTIONS:  See also Warning section.||
1752|159|I|   Drug interactions may change how your medications work or||
1752|160|I|increase your risk for serious side effects. This document does||
1752|161|I|not contain all possible drug interactions. Keep a list of all||
1752|162|I|the products you use (including prescription/nonprescription||
1752|163|I|drugs and herbal products) and share it with your doctor and||
1752|164|I|pharmacist. Do not start, stop, or change the dosage of any||
1752|165|I|medicines without your doctor's approval.||
1752|166|I|   Other medications can affect the removal of tofacitinib from||
1752|167|I|your body, which may affect how tofacitinib works. Examples||
1752|168|I|include rifampin, among others.||
1752|169|B|||
1752|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1752|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1752|172|O|poison control center right away. US residents can call||
1752|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1752|174|B|||
1752|175|N|NOTES:  Do not share this medication with others.||
1752|176|N|   Lab and/or medical tests (such as liver/kidney function,||
1752|177|N|complete blood count, cholesterol levels, skin exams) should be||
1752|178|N|done while you are taking this medication. Keep all medical and||
1752|179|N|lab appointments.||
1752|180|B|||
1752|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1752|182|D|remember. If it is near the time of the next dose, skip the||
1752|183|D|missed dose. Take your next dose at the regular time. Do not||
1752|184|D|double the dose to catch up.||
1752|185|B|||
1752|186|R|STORAGE:  Store at room temperature away from light and moisture.||
1752|187|R|Do not store in the bathroom. Keep all medications away from||
1752|188|R|children and pets.||
1752|189|R|   Do not flush medications down the toilet or pour them into a||
1752|190|R|drain unless instructed to do so. Properly discard this product||
1752|191|R|when it is expired or no longer needed. Consult your pharmacist||
1752|192|R|or local waste disposal company.||
1752|193|B|||
1752|194|M|MEDICAL ALERT:  Your condition can cause complications in a||
1752|195|M|medical emergency. For information about enrolling in MedicAlert,||
1752|196|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1752|197|B|||
1752|198|A|Information last revised November 2025.||
1752|199|A|Copyright(c) 2025 First Databank, Inc.||
1752|200|B|||
1753|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1753|002|Z|does NOT have all possible information about this product. This||
1753|003|Z|information does not assure that this product is safe, effective,||
1753|004|Z|or appropriate for you. This information is not individual||
1753|005|Z|medical advice and does not substitute for the advice of your||
1753|006|Z|health care professional. Always ask your health care||
1753|007|Z|professional for complete information about this product and your||
1753|008|Z|specific health needs.||
1753|009|B|||
1753|010|T|AMPHETAMINE EXTENDED-RELEASE DISINTEGRATING - ORAL||
1753|011|F|(am-FET-a-meen)||
1753|012|B|||
1753|013|C|COMMON BRAND NAME(S): Adzenys XR-ODT||
1753|014|B|||
1753|015|W|WARNING:  Misuse or abuse of amphetamines may cause serious||
1753|016|W|(possibly fatal) heart and blood pressure problems.||
1753|017|W|Amphetamine-type medications can be habit-forming. Use only as||
1753|018|W|directed. If you use this drug for a long time, you may become||
1753|019|W|dependent on it and may have withdrawal symptoms after stopping||
1753|020|W|the drug. Consult your doctor or pharmacist for more details.||
1753|021|W|(See also How to Use section.)||
1753|022|B|||
1753|023|U|USES:  This medication is used to treat attention deficit||
1753|024|U|hyperactivity disorder - ADHD. It works by changing the amounts||
1753|025|U|of certain natural substances in the brain. Amphetamine belongs||
1753|026|U|to a class of drugs known as stimulants. It can help increase||
1753|027|U|your ability to pay attention, stay focused on an activity, and||
1753|028|U|control behavior problems. It may also help you to organize your||
1753|029|U|tasks and improve listening skills.||
1753|030|B|||
1753|031|V|OTHER USES:  This section contains uses of this drug that are not||
1753|032|V|listed in the approved professional labeling for the drug but||
1753|033|V|that may be prescribed by your health care professional. Use this||
1753|034|V|drug for a condition that is listed in this section only if it||
1753|035|V|has been so prescribed by your health care professional.||
1753|036|V|   This drug may also be used for a certain sleeping disorder||
1753|037|V|(narcolepsy). It should not be used to treat tiredness or to hold||
1753|038|V|off sleep in people who do not have a sleep disorder.||
1753|039|B|||
1753|040|H|HOW TO USE:  Read the Medication Guide provided by your||
1753|041|H|pharmacist before you start taking amphetamine and each time you||
1753|042|H|get a refill. If you have any questions, ask your doctor or||
1753|043|H|pharmacist.||
1753|044|H|   Take this medication by mouth with or without food as directed||
1753|045|H|by your doctor, usually once daily in the morning. Taking this||
1753|046|H|medication after noon may cause trouble sleeping (insomnia).||
1753|047|H|   Keep the medication in the original package until you are||
1753|048|H|ready to take a dose. Dry your hands before handling the||
1753|049|H|medication. Peel back the foil layer of the blister pack to||
1753|050|H|remove a tablet. Do not push the tablet through the foil because||
1753|051|H|it may get damaged. Place the tablet on your tongue, allow it to||
1753|052|H|dissolve, and swallow with your saliva. You do not need to take||
1753|053|H|this medication with water or other liquid. Do not crush or chew||
1753|054|H|the tablet.||
1753|055|H|   The dosage is based on your medical condition and response to||
1753|056|H|treatment. Your doctor may adjust your dose to find the dose that||
1753|057|H|is best for you. Follow your doctor's instructions carefully.||
1753|058|H|   Use this medication regularly to get the most benefit from it.||
1753|059|H|To help you remember, take it at the same time each day.||
1753|060|H|   During treatment, your doctor may sometimes stop the||
1753|061|H|medication for a short time to see if the medication is still||
1753|062|H|needed.||
1753|063|H|   If you suddenly stop using this medication, you may have||
1753|064|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
1753|065|H|mental/mood changes such as depression). To help prevent||
1753|066|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1753|067|H|more likely if you have used amphetamine for a long time or in||
1753|068|H|high doses. Tell your doctor or pharmacist right away if you have||
1753|069|H|withdrawal.||
1753|070|H|   When this medication is used for a long time, it may not work||
1753|071|H|as well. Talk with your doctor if this medication stops working||
1753|072|H|well.||
1753|073|H|   Though it helps many people, this medication may sometimes||
1753|074|H|cause addiction. This risk may be higher if you have a substance||
1753|075|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1753|076|H|Take this medication exactly as prescribed to lower the risk of||
1753|077|H|addiction. Ask your doctor or pharmacist for more details.||
1753|078|H|   Tell your doctor if your condition does not get better or if||
1753|079|H|it gets worse.||
1753|080|B|||
1753|081|S|SIDE EFFECTS:  Loss of appetite, weight loss, dry mouth, stomach||
1753|082|S|upset/pain, nausea/vomiting, dizziness, headache, diarrhea,||
1753|083|S|fever, nervousness, and trouble sleeping may occur. If any of||
1753|084|S|these effects last or get worse, tell your doctor promptly.||
1753|085|S|   Remember that this medication has been prescribed because your||
1753|086|S|doctor has judged that the benefit to you is greater than the||
1753|087|S|risk of side effects. Many people using this medication do not||
1753|088|S|have serious side effects.||
1753|089|S|   This medication may raise your blood pressure. Check your||
1753|090|S|blood pressure regularly and tell your doctor if the results are||
1753|091|S|high.||
1753|092|S|   Tell your doctor right away if you have any serious side||
1753|093|S|effects, such as: signs of blood flow problems in the fingers or||
1753|094|S|toes (such as coldness, numbness, pain, or skin color changes),||
1753|095|S|unusual wounds on the fingers or toes, mental/mood/behavior||
1753|096|S|changes (such as agitation, aggression, mood swings, depression,||
1753|097|S|abnormal thoughts, thoughts of suicide), uncontrolled movements,||
1753|098|S|continuous chewing movements/teeth grinding, outbursts of||
1753|099|S|words/sounds, change in sexual ability/desire, frequent/prolonged||
1753|100|S|erections (in males).||
1753|101|S|   Get medical help right away if you have any very serious side||
1753|102|S|effects, such as: shortness of breath, chest/jaw/left arm pain,||
1753|103|S|unusual sweating, fainting, severe headache,||
1753|104|S|fast/pounding/irregular heartbeat, seizures, swelling||
1753|105|S|ankles/feet, extreme tiredness, blurred vision, weakness on one||
1753|106|S|side of the body, trouble speaking, confusion.||
1753|107|S|   This medication may increase serotonin and rarely cause a very||
1753|108|S|serious condition called serotonin syndrome/toxicity. The risk||
1753|109|S|increases if you are also taking other drugs that increase||
1753|110|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1753|111|S|take (see Drug Interactions section). Get medical help right away||
1753|112|S|if you develop some of the following symptoms: fast heartbeat,||
1753|113|S|hallucinations, loss of coordination, severe dizziness, severe||
1753|114|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1753|115|S|unusual agitation/restlessness.||
1753|116|S|   A very serious allergic reaction to this drug is rare.||
1753|117|S|However, get medical help right away if you notice any symptoms||
1753|118|S|of a serious allergic reaction, such as: rash, itching/swelling||
1753|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1753|120|S|breathing.||
1753|121|S|   This is not a complete list of possible side effects. If you||
1753|122|S|notice other effects not listed above, contact your doctor or||
1753|123|S|pharmacist.||
1753|124|S|   In the US -||
1753|125|S|   Call your doctor for medical advice about side effects. You||
1753|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1753|127|S|www.fda.gov/medwatch.||
1753|128|S|   In Canada - Call your doctor for medical advice about side||
1753|129|S|effects. You may report side effects to Health Canada at||
1753|130|S|1-866-234-2345.||
1753|131|B|||
1753|132|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1753|133|P|pharmacist if you are allergic to it; or to other sympathomimetic||
1753|134|P|drugs (such as lisdexamfetamine, dextroamphetamine); or if you||
1753|135|P|have any other allergies. This product may contain inactive||
1753|136|P|ingredients, which can cause allergic reactions or other||
1753|137|P|problems. Talk to your pharmacist for more details.||
1753|138|P|   Before using this medication, tell your doctor or pharmacist||
1753|139|P|your medical history, especially of: blood circulation problems||
1753|140|P|(such as Raynaud's syndrome), certain mental/mood conditions||
1753|141|P|(such as agitation, psychosis), personal/family history of||
1753|142|P|mental/mood disorders (such as bipolar disorder, depression,||
1753|143|P|psychotic disorder, suicidal thoughts), heart problems (including||
1753|144|P|irregular heartbeat/rhythm, coronary artery disease, heart||
1753|145|P|failure, cardiomyopathy, problems with the heart structure such||
1753|146|P|as valve problems), family history of heart problems (such as||
1753|147|P|sudden death/irregular heartbeat/rhythm), history of stroke, high||
1753|148|P|blood pressure, overactive thyroid (hyperthyroidism), a certain||
1753|149|P|eye problem (glaucoma), seizures, personal or family history of a||
1753|150|P|substance use disorder (such as overuse of or addiction to||
1753|151|P|drugs/alcohol), personal or family history of uncontrolled muscle||
1753|152|P|movements (such as Tourette syndrome), kidney disease, liver||
1753|153|P|disease.||
1753|154|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1753|155|P|can make you more dizzy. Do not drive, use machinery, or do||
1753|156|P|anything that needs alertness until you can do it safely. Limit||
1753|157|P|alcoholic beverages. Talk to your doctor if you are using||
1753|158|P|marijuana (cannabis).||
1753|159|P|   Before having surgery, tell your doctor or dentist about all||
1753|160|P|the products you use (including prescription drugs,||
1753|161|P|nonprescription drugs, and herbal products).||
1753|162|P|   Children (especially those younger than 6) may be more||
1753|163|P|sensitive to the side effects of this drug, especially weight||
1753|164|P|loss. This medication may slow down a child's growth. See the||
1753|165|P|doctor regularly so your child's height and growth can be||
1753|166|P|checked. Consult your doctor or pharmacist for more details.||
1753|167|P|   Older adults may be more sensitive to the side effects of this||
1753|168|P|drug, especially chest pain, trouble sleeping, or weight loss.||
1753|169|P|   During pregnancy, this medication should be used only when||
1753|170|P|clearly needed. Discuss the risks and benefits with your doctor.||
1753|171|P|Babies born to mothers who are dependent on this medication may||
1753|172|P|be born too soon (premature) and have low birth weight. They may||
1753|173|P|also have withdrawal symptoms. Tell your doctor right away if you||
1753|174|P|notice possible mood changes, agitation, or unusual tiredness in||
1753|175|P|your newborn.||
1753|176|P|   This medication passes into breast milk and may have||
1753|177|P|undesirable effects on a nursing infant. Breastfeeding is not||
1753|178|P|recommended while using this medication. Consult your doctor||
1753|179|P|before breastfeeding.||
1753|180|B|||
1753|181|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1753|182|I|medications work or increase your risk for serious side effects.||
1753|183|I|This document does not contain all possible drug interactions.||
1753|184|I|Keep a list of all the products you use (including||
1753|185|I|prescription/nonprescription drugs and herbal products) and share||
1753|186|I|it with your doctor and pharmacist. Do not start, stop, or change||
1753|187|I|the dosage of any medicines without your doctor's approval.||
1753|188|I|   Taking MAO inhibitors with this medication may cause a serious||
1753|189|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1753|190|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1753|191|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1753|192|I|selegiline, tranylcypromine) during treatment with this||
1753|193|I|medication. Most MAO inhibitors should also not be taken for two||
1753|194|I|weeks before treatment with this medication. Ask your doctor when||
1753|195|I|to start or stop taking this medication.||
1753|196|I|   Some products have ingredients that could raise your heart||
1753|197|I|rate or blood pressure. Tell your pharmacist what products you||
1753|198|I|are using, and ask how to use them safely (especially||
1753|199|I|cough-and-cold products or diet aids).||
1753|200|I|   The risk of serotonin syndrome/toxicity increases if you are||
1753|201|I|also taking other drugs that increase serotonin. Examples include||
1753|202|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
1753|203|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1753|204|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1753|205|I|serotonin syndrome/toxicity may be more likely when you start or||
1753|206|I|increase the dose of these drugs.||
1753|207|I|   Amphetamine is very similar to dextroamphetamine or||
1753|208|I|lisdexamfetamine. Do not use medications containing||
1753|209|I|dextroamphetamine or lisdexamfetamine while using amphetamine.||
1753|210|I|   This medication may interfere with certain lab tests (such as||
1753|211|I|blood and urine steroid levels, brain scan for Parkinson's||
1753|212|I|disease), possibly causing false test results. Make sure lab||
1753|213|I|personnel and all your doctors know you use this drug.||
1753|214|B|||
1753|215|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1753|216|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1753|217|O|poison control center right away. US residents can call||
1753|218|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1753|219|O|Symptoms of overdose may include: severe mental/mood changes,||
1753|220|O|seizures, headache that is severe or doesn't go away, severe||
1753|221|O|restlessness, fast breathing.||
1753|222|B|||
1753|223|N|NOTES:  Do not share this medication with others. Sharing it is||
1753|224|N|against the law.||
1753|225|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
1753|226|N|growth checks in children) may be done while you are taking this||
1753|227|N|medication. Keep all medical and lab appointments.||
1753|228|B|||
1753|229|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
1753|230|D|in the morning hours. If it is after noon or near the time of the||
1753|231|D|next dose, skip the missed dose. Take your next dose at the||
1753|232|D|regular time. Do not double the dose to catch up.||
1753|233|B|||
1753|234|R|STORAGE:  Store at room temperature away from light and moisture.||
1753|235|R|Do not store in the bathroom. Keep all medications away from||
1753|236|R|children and pets.||
1753|237|R|   Do not flush medications down the toilet or pour them into a||
1753|238|R|drain unless instructed to do so. Properly discard this product||
1753|239|R|when it is expired or no longer needed. Consult your pharmacist||
1753|240|R|or local waste disposal company.||
1753|241|B|||
1753|242|A|Information last revised July 2025.||
1753|243|A|Copyright(c) 2025 First Databank, Inc.||
1753|244|B|||
1754|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1754|002|Z|does NOT have all possible information about this product. This||
1754|003|Z|information does not assure that this product is safe, effective,||
1754|004|Z|or appropriate for you. This information is not individual||
1754|005|Z|medical advice and does not substitute for the advice of your||
1754|006|Z|health care professional. Always ask your health care||
1754|007|Z|professional for complete information about this product and your||
1754|008|Z|specific health needs.||
1754|009|B|||
1754|010|T|IXEKIZUMAB - INJECTION||
1754|011|F|(IX-ee-KIZ-ue-mab)||
1754|012|B|||
1754|013|C|COMMON BRAND NAME(S): Taltz||
1754|014|B|||
1754|015|U|USES:  This medication is used to treat plaque psoriasis and||
1754|016|U|certain types of arthritis (psoriatic arthritis, ankylosing||
1754|017|U|spondylitis, axial spondyloarthritis). Ixekizumab belongs to a||
1754|018|U|class of drugs known as monoclonal antibodies. It works by||
1754|019|U|blocking a certain natural protein in your body (interleukin-17A)||
1754|020|U|that may cause inflammation and swelling.||
1754|021|B|||
1754|022|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1754|023|H|provided by your pharmacist before you start using ixekizumab and||
1754|024|H|each time you get a refill. Ask your health care professional how||
1754|025|H|to prepare and use this medication. If you have any questions,||
1754|026|H|ask your doctor or pharmacist.||
1754|027|H|   Before treatment with this medication, your doctor will make||
1754|028|H|sure that you have received all your vaccinations and also test||
1754|029|H|you for tuberculosis (TB). Your doctor should also monitor you||
1754|030|H|for symptoms of TB during and after treatment with this drug. If||
1754|031|H|needed, treatment for tuberculosis or other infections should be||
1754|032|H|given before receiving this medication.||
1754|033|H|   Inject this medication under the skin as directed by your||
1754|034|H|doctor. The injection is given in the upper arms, thighs, or||
1754|035|H|abdomen (at least 1 inch from your belly button). The dosage and||
1754|036|H|treatment schedule are based on your medical condition and||
1754|037|H|response to treatment. Children's dosage is also based on weight.||
1754|038|H|   Take the medication out of the refrigerator 30 minutes before||
1754|039|H|you inject it to allow it to reach room temperature. Do not warm||
1754|040|H|up this medication any other way (for example, do not heat it in||
1754|041|H|the microwave, place it in hot water, or leave it in direct||
1754|042|H|sunlight). Do not shake the medication. Before using, check this||
1754|043|H|product for cloudiness, particles, or discoloration. If you see||
1754|044|H|any of these things, do not use the liquid. Before injecting each||
1754|045|H|dose, clean the skin you are going to inject into (the injection||
1754|046|H|site) with rubbing alcohol. Change the injection site each time||
1754|047|H|to lessen injury under the skin. Do not inject into skin that is||
1754|048|H|irritated, sore, bruised, red, hard, or affected by psoriasis. To||
1754|049|H|lessen bruising, do not rub the injection site after a shot.||
1754|050|H|Learn how to store and discard medical supplies safely.||
1754|051|H|   Use this medication regularly to get the most benefit from it.||
1754|052|H|To help you remember, mark your calendar with a reminder.||
1754|053|H|   Tell your doctor if your condition does not get better or if||
1754|054|H|it gets worse.||
1754|055|B|||
1754|056|S|SIDE EFFECTS:  Redness, irritation, or pain at the injection site||
1754|057|S|may occur. Cold symptoms (such as runny/stuffy nose, cough) may||
1754|058|S|also occur. If any of these effects last or get worse, tell your||
1754|059|S|doctor or pharmacist promptly.||
1754|060|S|   Remember that this medication has been prescribed because your||
1754|061|S|doctor has judged that the benefit to you is greater than the||
1754|062|S|risk of side effects. Many people using this medication do not||
1754|063|S|have serious side effects.||
1754|064|S|   This medication may lower your ability to fight infections.||
1754|065|S|This may make you more likely to get a serious (rarely fatal)||
1754|066|S|infection or make any infection you have worse. Tell your doctor||
1754|067|S|right away if you have any signs of infection (such as a sore||
1754|068|S|throat that doesn't go away, fever, chills).||
1754|069|S|   Tell your doctor right away if you have any serious side||
1754|070|S|effects, such as: stomach/abdominal pain, diarrhea with||
1754|071|S|blood/mucus.||
1754|072|S|   A very serious allergic reaction to this drug is rare.||
1754|073|S|However, get medical help right away if you notice any symptoms||
1754|074|S|of a serious allergic reaction, such as: rash, itching/swelling||
1754|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1754|076|S|breathing.||
1754|077|S|   This is not a complete list of possible side effects. If you||
1754|078|S|notice other effects not listed above, contact your doctor or||
1754|079|S|pharmacist.||
1754|080|S|   In the US -||
1754|081|S|   Call your doctor for medical advice about side effects. You||
1754|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1754|083|S|www.fda.gov/medwatch.||
1754|084|S|   In Canada - Call your doctor for medical advice about side||
1754|085|S|effects. You may report side effects to Health Canada at||
1754|086|S|1-866-234-2345.||
1754|087|B|||
1754|088|P|PRECAUTIONS:  Before using ixekizumab, tell your doctor or||
1754|089|P|pharmacist if you are allergic to it; or if you have any other||
1754|090|P|allergies. This product may contain inactive ingredients, which||
1754|091|P|can cause allergic reactions or other problems. Talk to your||
1754|092|P|pharmacist for more details.||
1754|093|P|   Before using this medication, tell your doctor or pharmacist||
1754|094|P|your medical history, especially of: current/recent/returning||
1754|095|P|infection (such as tuberculosis, herpes), bowel disease (such as||
1754|096|P|Crohn's disease, ulcerative colitis).||
1754|097|P|   Ixekizumab can make you more likely to get infections or may||
1754|098|P|make current infections worse. Stay away from anyone who has an||
1754|099|P|infection that may easily spread (such as chickenpox, COVID-19,||
1754|100|P|measles, flu). Talk to your doctor if you have been exposed to an||
1754|101|P|infection or for more details.||
1754|102|P|   Tell your health care professional that you are using||
1754|103|P|ixekizumab before having any immunizations/vaccinations. Avoid||
1754|104|P|contact with people who have recently received live vaccines||
1754|105|P|(such as flu vaccine inhaled through the nose).||
1754|106|P|   Before having surgery, tell your doctor or dentist about all||
1754|107|P|the products you use (including prescription drugs,||
1754|108|P|nonprescription drugs, and herbal products).||
1754|109|P|   During pregnancy, this medication should be used only when||
1754|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
1754|111|P|   It is unknown if this medication passes into breast milk.||
1754|112|P|Consult your doctor before breastfeeding.||
1754|113|B|||
1754|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1754|115|I|medications work or increase your risk for serious side effects.||
1754|116|I|This document does not contain all possible drug interactions.||
1754|117|I|Keep a list of all the products you use (including||
1754|118|I|prescription/nonprescription drugs and herbal products) and share||
1754|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
1754|120|I|the dosage of any medicines without your doctor's approval.||
1754|121|B|||
1754|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1754|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1754|124|O|poison control center right away. US residents can call||
1754|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1754|126|B|||
1754|127|N|NOTES:  Do not share this medication with others.||
1754|128|N|   Lab and/or medical tests (such as complete blood count) may be||
1754|129|N|done while you are using this medication. Keep all medical and||
1754|130|N|lab appointments.||
1754|131|B|||
1754|132|D|MISSED DOSE:  It is important to get each dose of this medication||
1754|133|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1754|134|D|right away for a new dosing schedule. Do not double the dose to||
1754|135|D|catch up.||
1754|136|B|||
1754|137|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1754|138|R|medication in the original carton to protect from light. This||
1754|139|R|medication may also be stored at room temperature if needed. If||
1754|140|R|the medication is stored at room temperature, do not put it back||
1754|141|R|in the refrigerator and discard after 5 days. Discard any unused||
1754|142|R|portion after use. Keep all medications away from children and||
1754|143|R|pets.||
1754|144|R|   Do not flush medications down the toilet or pour them into a||
1754|145|R|drain unless instructed to do so. Properly discard this product||
1754|146|R|when it is expired or no longer needed. Consult your pharmacist||
1754|147|R|or local waste disposal company.||
1754|148|B|||
1754|149|A|Information last revised May 2025.||
1754|150|A|Copyright(c) 2025 First Databank, Inc.||
1754|151|B|||
1755|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1755|002|Z|does NOT have all possible information about this product. This||
1755|003|Z|information does not assure that this product is safe, effective,||
1755|004|Z|or appropriate for you. This information is not individual||
1755|005|Z|medical advice and does not substitute for the advice of your||
1755|006|Z|health care professional. Always ask your health care||
1755|007|Z|professional for complete information about this product and your||
1755|008|Z|specific health needs.||
1755|009|B|||
1755|010|T|BETAMETHASONE DIPROPIONATE SPRAY - TOPICAL||
1755|011|F|(BAY-ta-METH-a-sone dye-PROE-pee-oh-nate)||
1755|012|B|||
1755|013|C|COMMON BRAND NAME(S): Sernivo||
1755|014|B|||
1755|015|U|USES:  This medication is used to treat a type of skin condition||
1755|016|U|(plaque psoriasis). Betamethasone reduces the swelling, itching,||
1755|017|U|and redness that may occur with plaque psoriasis. This medication||
1755|018|U|is a strong corticosteroid.||
1755|019|B|||
1755|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
1755|021|H|Instructions for Use if available from your pharmacist before you||
1755|022|H|start using betamethasone and each time you get a refill. If you||
1755|023|H|have any questions, ask your doctor or pharmacist.||
1755|024|H|   This medication is for use on the skin only. Unless your||
1755|025|H|doctor directs you to do so, do not use it on the face, scalp,||
1755|026|H|groin, underarms, or other areas where your skin may touch or rub||
1755|027|H|together. Avoid getting this medication in the eyes, mouth, or||
1755|028|H|vagina. If this occurs, rinse with plenty of water. Do not use it||
1755|029|H|on thinning skin.||
1755|030|H|   Shake the bottle well before each dose. Wash and dry your||
1755|031|H|hands before applying the medication, then clean and dry the||
1755|032|H|affected area. Spray only enough medication to cover the affected||
1755|033|H|areas with a thin film and gently rub in as directed by your||
1755|034|H|doctor, usually 2 times daily. Do not cover, bandage, or wrap the||
1755|035|H|area unless directed to do so by your doctor. After applying the||
1755|036|H|medication, wash your hands unless you are using this medication||
1755|037|H|to treat the hands.||
1755|038|H|   Use this medication only for the condition prescribed. Once||
1755|039|H|your skin condition is under control, you should stop using||
1755|040|H|betamethasone unless directed by your doctor. Do not use it for||
1755|041|H|longer than prescribed. According to the manufacturer, you should||
1755|042|H|not use this drug for longer than 4 weeks.||
1755|043|H|   Tell your doctor if your condition does not get better or if||
1755|044|H|it gets worse after 4 weeks.||
1755|045|B|||
1755|046|S|SIDE EFFECTS:  Burning, itching, irritation, or dryness at the||
1755|047|S|application site may occur. If any of these effects last or get||
1755|048|S|worse, tell your doctor or pharmacist promptly.||
1755|049|S|   Remember that this medication has been prescribed because your||
1755|050|S|doctor has judged that the benefit to you is greater than the||
1755|051|S|risk of side effects. Many people using this medication do not||
1755|052|S|have serious side effects.||
1755|053|S|   Tell your doctor right away if you have any serious side||
1755|054|S|effects, including: stretch marks, skin thinning/discoloration,||
1755|055|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
1755|056|S|(folliculitis).||
1755|057|S|   Skin infections can become worse when this medication is used.||
1755|058|S|Tell your doctor right away if redness, swelling, or irritation||
1755|059|S|does not improve.||
1755|060|S|   Rarely, it is possible this medication will be absorbed from||
1755|061|S|the skin into the bloodstream. This can lead to side effects of||
1755|062|S|too much corticosteroid. These side effects are more likely in||
1755|063|S|children, and in people who use this medication for a long time||
1755|064|S|or over large areas of the skin. Tell your doctor right away if||
1755|065|S|any of the following side effects occur: unusual/extreme||
1755|066|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
1755|067|S|thirst/urination, vision problems.||
1755|068|S|   A very serious allergic reaction to this drug is rare.||
1755|069|S|However, get medical help right away if you notice any symptoms||
1755|070|S|of a serious allergic reaction, including: rash, itching/swelling||
1755|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1755|072|S|breathing.||
1755|073|S|   This is not a complete list of possible side effects. If you||
1755|074|S|notice other effects not listed above, contact your doctor or||
1755|075|S|pharmacist.||
1755|076|S|   In the US -||
1755|077|S|   Call your doctor for medical advice about side effects. You||
1755|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1755|079|S|www.fda.gov/medwatch.||
1755|080|S|   In Canada - Call your doctor for medical advice about side||
1755|081|S|effects. You may report side effects to Health Canada at||
1755|082|S|1-866-234-2345.||
1755|083|B|||
1755|084|P|PRECAUTIONS:  Before using betamethasone, tell your doctor or||
1755|085|P|pharmacist if you are allergic to it; or to other corticosteroids||
1755|086|P|(such as hydrocortisone, prednisone); or if you have any other||
1755|087|P|allergies. This product may contain inactive ingredients, which||
1755|088|P|can cause allergic reactions or other problems. Talk to your||
1755|089|P|pharmacist for more details.||
1755|090|P|   Before using this medication, tell your doctor or pharmacist||
1755|091|P|your medical history, especially of: poor blood circulation,||
1755|092|P|immune system problems.||
1755|093|P|   Do not use on sores or on skin that is infected or thinning.||
1755|094|P|   Rarely, using corticosteroid medications for a long time or||
1755|095|P|over large areas of skin can make it more difficult for your body||
1755|096|P|to respond to physical stress. Before having surgery or emergency||
1755|097|P|treatment, or if you get a serious illness/injury, tell your||
1755|098|P|doctor or dentist that you are using this medication or have used||
1755|099|P|this medication within the past few months.||
1755|100|P|   Though it is unlikely, this medication may temporarily slow||
1755|101|P|down a child's growth if used for a long time. See the doctor||
1755|102|P|regularly so your child's height can be checked.||
1755|103|P|   During pregnancy, this medication should be used only when||
1755|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
1755|105|P|   It is unknown if this drug passes into breast milk. Similar||
1755|106|P|medications pass into breast milk. Consult your doctor before||
1755|107|P|breastfeeding.||
1755|108|B|||
1755|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1755|110|I|medications work or increase your risk for serious side effects.||
1755|111|I|This document does not contain all possible drug interactions.||
1755|112|I|Keep a list of all the products you use (including||
1755|113|I|prescription/nonprescription drugs and herbal products) and share||
1755|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
1755|115|I|the dosage of any medicines without your doctor's approval.||
1755|116|B|||
1755|117|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1755|118|O|has overdosed and has serious symptoms such as passing out or||
1755|119|O|trouble breathing, call 911. Otherwise, call a poison control||
1755|120|O|center right away. US residents can call 1-800-222-1222. Canada||
1755|121|O|residents can call 1-844-764-7669.||
1755|122|B|||
1755|123|N|NOTES:  Do not share this medication with others.||
1755|124|N|   Lab and/or medical tests (such as adrenal gland function) may||
1755|125|N|be done while you are using this medication, especially if you||
1755|126|N|use this drug for a long time or apply it over large areas of the||
1755|127|N|body. Keep all medical and lab appointments. Consult your doctor||
1755|128|N|for more details.||
1755|129|N|   This medication has been prescribed for your current condition||
1755|130|N|only. Do not use it later for other skin problems unless your||
1755|131|N|doctor directs you to do so. A different medication may be||
1755|132|N|necessary in that case.||
1755|133|B|||
1755|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1755|135|D|If it is near the time of the next dose, skip the missed dose.||
1755|136|D|Use your next dose at the regular time. Do not double the dose to||
1755|137|D|catch up.||
1755|138|B|||
1755|139|R|STORAGE:  Store at room temperature. Discard any unused portion||
1755|140|R|after 28 days. Keep all medications away from children and pets.||
1755|141|R|   Do not flush medications down the toilet or pour them into a||
1755|142|R|drain unless instructed to do so. Properly discard this product||
1755|143|R|when it is expired or no longer needed. Consult your pharmacist||
1755|144|R|or local waste disposal company.||
1755|145|B|||
1755|146|A|Information last revised January 2025.||
1755|147|A|Copyright(c) 2025 First Databank, Inc.||
1755|148|B|||
1756|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1756|002|Z|does NOT have all possible information about this product. This||
1756|003|Z|information does not assure that this product is safe, effective,||
1756|004|Z|or appropriate for you. This information is not individual||
1756|005|Z|medical advice and does not substitute for the advice of your||
1756|006|Z|health care professional. Always ask your health care||
1756|007|Z|professional for complete information about this product and your||
1756|008|Z|specific health needs.||
1756|009|B|||
1756|010|T|RESLIZUMAB - INJECTION||
1756|011|F|(res-LIZ-ue-mab)||
1756|012|B|||
1756|013|C|COMMON BRAND NAME(S): Cinqair||
1756|014|B|||
1756|015|W|WARNING:  This medication may rarely cause a serious allergic||
1756|016|W|reaction. You should receive this medication in a hospital or||
1756|017|W|clinic so your doctor can watch you closely and lessen the risk.||
1756|018|W|Get medical help right away if you notice any symptoms of a||
1756|019|W|serious allergic reaction such as rash, flushing,||
1756|020|W|itching/swelling (especially of the face/tongue/throat), severe||
1756|021|W|dizziness, or trouble breathing.||
1756|022|B|||
1756|023|U|USES:  This medication is used along with other medications to||
1756|024|U|control and prevent symptoms (such as wheezing and shortness of||
1756|025|U|breath) caused by asthma. Controlling symptoms of asthma helps||
1756|026|U|you do your normal activities and decreases time lost from work||
1756|027|U|or school. Reslizumab belongs to a class of drugs known as||
1756|028|U|monoclonal antibodies. It works by reducing swelling||
1756|029|U|(inflammation) of the airways in the lungs to make breathing||
1756|030|U|easier.||
1756|031|U|   This medication must be used regularly to be effective. It||
1756|032|U|does not work right away and should not be used to relieve sudden||
1756|033|U|asthma attacks or breathing problems. If an asthma attack occurs,||
1756|034|U|use your quick-relief inhaler as prescribed.||
1756|035|B|||
1756|036|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1756|037|H|from your pharmacist before you start using reslizumab and each||
1756|038|H|time you get a refill. If you have any questions, ask your doctor||
1756|039|H|or pharmacist.||
1756|040|H|   This medication is given by injection into a vein as directed||
1756|041|H|by your doctor, usually once every 4 weeks. It is given by a||
1756|042|H|health care professional, usually over 20 to 50 minutes. The||
1756|043|H|dosage is based on your medical condition and response to||
1756|044|H|treatment.||
1756|045|H|   If you are also using a corticosteroid medication, you should||
1756|046|H|not stop using it unless directed by your doctor. Your condition||
1756|047|H|may worsen when the drug is suddenly stopped. If you suddenly||
1756|048|H|stop using the corticosteroid medication, you may also have||
1756|049|H|withdrawal symptoms (such as weakness, weight loss, nausea,||
1756|050|H|muscle pain, headache, tiredness, dizziness). To help prevent||
1756|051|H|withdrawal, your doctor may slowly lower the dose of your||
1756|052|H|corticosteroid medication after you begin using reslizumab. Tell||
1756|053|H|your doctor or pharmacist right away if you have withdrawal.||
1756|054|H|   Use this medication regularly to get the most benefit from it.||
1756|055|H|To help you remember, mark your calendar with a reminder.||
1756|056|H|   Tell your doctor if your condition does not get better or if||
1756|057|H|it gets worse.||
1756|058|B|||
1756|059|S|SIDE EFFECTS:  See also Warning section.||
1756|060|S|   Neck or throat pain may occur. If either of these effects||
1756|061|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
1756|062|S|   Remember that this medication has been prescribed because your||
1756|063|S|doctor has judged that the benefit to you is greater than the||
1756|064|S|risk of side effects. Many people using this medication do not||
1756|065|S|have serious side effects.||
1756|066|S|   Tell your doctor right away if you have any serious side||
1756|067|S|effects, including: muscle ache/pain/spasms/weakness.||
1756|068|S|   Rarely, this medication may increase the risk of developing||
1756|069|S|cancer. Ask your doctor for details.||
1756|070|S|   This is not a complete list of possible side effects. If you||
1756|071|S|notice other effects not listed above, contact your doctor or||
1756|072|S|pharmacist.||
1756|073|S|   In the US -||
1756|074|S|   Call your doctor for medical advice about side effects. You||
1756|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1756|076|S|www.fda.gov/medwatch.||
1756|077|S|   In Canada - Call your doctor for medical advice about side||
1756|078|S|effects. You may report side effects to Health Canada at||
1756|079|S|1-866-234-2345.||
1756|080|B|||
1756|081|P|PRECAUTIONS:  Before using reslizumab, tell your doctor or||
1756|082|P|pharmacist if you are allergic to it; or if you have any other||
1756|083|P|allergies. This product may contain inactive ingredients, which||
1756|084|P|can cause allergic reactions or other problems. Talk to your||
1756|085|P|pharmacist for more details.||
1756|086|P|   Before using this medication, tell your doctor or pharmacist||
1756|087|P|your medical history, especially of: infection due to a parasite.||
1756|088|P|   Before having surgery, tell your doctor or dentist about all||
1756|089|P|the products you use (including prescription drugs,||
1756|090|P|nonprescription drugs, and herbal products).||
1756|091|P|   During pregnancy, this medication should be used only when||
1756|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
1756|093|P|   It is unknown if this medication passes into breast milk.||
1756|094|P|Consult your doctor before breastfeeding.||
1756|095|B|||
1756|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1756|097|I|medications work or increase your risk for serious side effects.||
1756|098|I|This document does not contain all possible drug interactions.||
1756|099|I|Keep a list of all the products you use (including||
1756|100|I|prescription/nonprescription drugs and herbal products) and share||
1756|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
1756|102|I|the dosage of any medicines without your doctor's approval.||
1756|103|B|||
1756|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1756|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1756|106|O|poison control center right away. US residents can call||
1756|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1756|108|B|||
1756|109|N|NOTES:  Keep all medical and lab appointments.||
1756|110|B|||
1756|111|D|MISSED DOSE:  It is important to get each dose of this medication||
1756|112|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1756|113|D|right away for a new dosing schedule.||
1756|114|B|||
1756|115|R|STORAGE:  Not applicable. This medication is given in a hospital||
1756|116|R|or clinic or doctor's office and will not be stored at home.||
1756|117|B|||
1756|118|A|Information last revised October 2024.||
1756|119|A|Copyright(c) 2025 First Databank, Inc.||
1756|120|B|||
1757|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1757|002|Z|does NOT have all possible information about this product. This||
1757|003|Z|information does not assure that this product is safe, effective,||
1757|004|Z|or appropriate for you. This information is not individual||
1757|005|Z|medical advice and does not substitute for the advice of your||
1757|006|Z|health care professional. Always ask your health care||
1757|007|Z|professional for complete information about this product and your||
1757|008|Z|specific health needs.||
1757|009|B|||
1757|010|T|EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL||
1757|011|F|(EM-trye-SYE-ta-been/ten-OF-oh-vir AL-a-FEN-a-mide)||
1757|012|B|||
1757|013|C|COMMON BRAND NAME(S): Descovy||
1757|014|B|||
1757|015|W|WARNING:  If you have hepatitis B infection as well as HIV, your||
1757|016|W|hepatitis symptoms may get worse or become very serious if you||
1757|017|W|stop taking this medication. Talk with your doctor before||
1757|018|W|stopping this medication. Your doctor will check liver function||
1757|019|W|tests for several months after you stop.||
1757|020|W|   If you are taking this product to prevent HIV infection, you||
1757|021|W|must first get tested to be sure you are HIV-negative. Your||
1757|022|W|doctor will perform lab tests before starting this medication and||
1757|023|W|periodically during treatment (every 3 months) to make sure that||
1757|024|W|you do not have HIV infection. Using this product will not always||
1757|025|W|prevent HIV infection. To get the most benefit from it, take this||
1757|026|W|product exactly as directed, and follow all prevention actions.||
1757|027|W|(See also Uses section.) Tell your doctor right away if you have||
1757|028|W|any signs of HIV infection (such as sore throat that doesn't go||
1757|029|W|away, tiredness, fever, night sweats, diarrhea, joint/muscle||
1757|030|W|aches, enlarged lymph nodes).||
1757|031|B|||
1757|032|U|USES:  This product is used with other HIV medications to help||
1757|033|U|control HIV infection. It helps to decrease the amount of HIV in||
1757|034|U|your body so your immune system can work better. This lowers your||
1757|035|U|chance of getting HIV complications (such as new infections,||
1757|036|U|cancer) and improves your quality of life. This product is a||
1757|037|U|combination of two different drugs: emtricitabine and tenofovir||
1757|038|U|alafenamide. Emtricitabine is called a nucleoside reverse||
1757|039|U|transcriptase inhibitor, while tenofovir alafenamide is called a||
1757|040|U|nucleotide reverse transcriptase inhibitor. They are often called||
1757|041|U|NRTIs.||
1757|042|U|   This product should not be used by itself to help control HIV||
1757|043|U|infection. Doing so can make your treatment less effective. Use||
1757|044|U|combination treatment with at least one other HIV medication.||
1757|045|U|   This product is also approved in the US to help prevent HIV||
1757|046|U|infection in people who have a high risk for infection. Some||
1757|047|U|things that increase risk include having a partner infected with||
1757|048|U|HIV, having unprotected sex, having multiple sex partners,||
1757|049|U|infection with a sexually transmitted disease-STD, or use/abuse||
1757|050|U|of drugs or alcohol.||
1757|051|U|   Emtricitabine/tenofovir alafenamide is not a cure for HIV||
1757|052|U|infection. To decrease your risk of spreading HIV disease to||
1757|053|U|others, continue to take all HIV medications exactly as||
1757|054|U|prescribed by your doctor. Use an effective barrier method (latex||
1757|055|U|or polyurethane condoms/dental dams) during sexual activity as||
1757|056|U|directed by your doctor. Do not share personal items (such as||
1757|057|U|needles/syringes, toothbrushes, and razors) that may have||
1757|058|U|contacted blood or other body fluids. Consult your doctor or||
1757|059|U|pharmacist for more details.||
1757|060|B|||
1757|061|H|HOW TO USE:  Read the Medication Guide provided by your||
1757|062|H|pharmacist before you start taking this medication and each time||
1757|063|H|you get a refill. If you have any questions, ask your doctor or||
1757|064|H|pharmacist.||
1757|065|H|   Take this medication by mouth as directed by your doctor,||
1757|066|H|usually once daily with or without food. The dosage is based on||
1757|067|H|your medical condition and response to treatment. Children's||
1757|068|H|dosage is also based on weight.||
1757|069|H|   When used to treat HIV infection, this product is taken with||
1757|070|H|other medicines that treat HIV. If you are also taking didanosine||
1757|071|H|enteric-coated tablets, take both products either on an empty||
1757|072|H|stomach or with a light meal. If you are taking the didanosine||
1757|073|H|buffered tablets, take both drug products on an empty stomach.||
1757|074|H|   It is very important to keep taking this medication (and other||
1757|075|H|HIV medications) exactly as prescribed by your doctor. Do not||
1757|076|H|skip any doses.||
1757|077|H|   For the best effect, take this medication at evenly spaced||
1757|078|H|times. To help you remember, take this medication at the same||
1757|079|H|time every day.||
1757|080|H|   Do not take more or less of this drug than prescribed or stop||
1757|081|H|taking it (or other HIV medicines) even for a short time unless||
1757|082|H|directed to do so by your doctor. Doing so may cause the amount||
1757|083|H|of virus to increase, make the infection more difficult to treat||
1757|084|H|(resistant), or worsen side effects.||
1757|085|B|||
1757|086|S|SIDE EFFECTS:  Diarrhea, headache, trouble sleeping, back pain,||
1757|087|S|or change in the color of skin on your palms or soles of your||
1757|088|S|feet may occur. If any of these effects last or get worse, tell||
1757|089|S|your doctor or pharmacist promptly.||
1757|090|S|   Remember that this medication has been prescribed because your||
1757|091|S|doctor has judged that the benefit to you is greater than the||
1757|092|S|risk of side effects. Many people using this medication do not||
1757|093|S|have serious side effects.||
1757|094|S|   As your immune system gets stronger with HIV treatment, it can||
1757|095|S|begin to fight off infections you already had, possibly causing||
1757|096|S|disease symptoms to come back. You could also have symptoms if||
1757|097|S|your immune system becomes overactive. This reaction may happen||
1757|098|S|at any time (soon after starting HIV treatment or many months||
1757|099|S|later). Tell your doctor right away if you have any serious||
1757|100|S|symptoms, including: unexplained weight loss, severe tiredness,||
1757|101|S|muscle aches/weakness that doesn't go away, headaches that are||
1757|102|S|severe or don't go away, joint pain, numbness/tingling of the||
1757|103|S|hands/feet/arms/legs, vision changes, signs of infection (such as||
1757|104|S|sore throat the doesn't go away, fever, chills, swollen lymph||
1757|105|S|nodes, non-healing skin sores), signs of an overactive thyroid||
1757|106|S|(such as irritability, nervousness, heat intolerance,||
1757|107|S|fast/pounding/irregular heartbeat).||
1757|108|S|   Tell your doctor right away if you have any serious side||
1757|109|S|effects, including: mental/mood changes (such as depression,||
1757|110|S|anxiety), signs of kidney problems (such as change in the amount||
1757|111|S|of urine, pink/bloody urine).||
1757|112|S|   Rarely, this medication can cause severe (sometimes fatal)||
1757|113|S|liver and blood problems (lactic acidosis). Tell your doctor||
1757|114|S|right away if you develop symptoms of liver problems (such as||
1757|115|S|nausea/vomiting that doesn't stop, loss of appetite,||
1757|116|S|stomach/abdominal pain, yellowing eyes/skin, dark urine) or||
1757|117|S|lactic acidosis (such as deep/rapid breathing, drowsiness,||
1757|118|S|nausea/vomiting, unusual weakness).||
1757|119|S|   A very serious allergic reaction to this drug is rare.||
1757|120|S|However, get medical help right away if you notice any symptoms||
1757|121|S|of a serious allergic reaction, including: rash, itching/swelling||
1757|122|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1757|123|S|breathing.||
1757|124|S|   This is not a complete list of possible side effects. If you||
1757|125|S|notice other effects not listed above, contact your doctor or||
1757|126|S|pharmacist.||
1757|127|S|   In the US -||
1757|128|S|   Call your doctor for medical advice about side effects. You||
1757|129|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1757|130|S|www.fda.gov/medwatch.||
1757|131|S|   In Canada - Call your doctor for medical advice about side||
1757|132|S|effects. You may report side effects to Health Canada at||
1757|133|S|1-866-234-2345.||
1757|134|B|||
1757|135|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1757|136|P|pharmacist if you are allergic to emtricitabine or tenofovir; or||
1757|137|P|if you have any other allergies. This product may contain||
1757|138|P|inactive ingredients, which can cause allergic reactions or other||
1757|139|P|problems. Talk to your pharmacist for more details.||
1757|140|P|   Before using this medication, tell your doctor or pharmacist||
1757|141|P|your medical history, especially of: pancreatitis, liver problems||
1757|142|P|(hepatitis B, hepatitis C, cirrhosis), alcohol use, bone problems||
1757|143|P|(such as bone disease, bone loss/osteoporosis, weak/broken||
1757|144|P|bones), kidney disease.||
1757|145|P|   Before having surgery, tell your doctor or dentist about all||
1757|146|P|the products you use (including prescription drugs,||
1757|147|P|nonprescription drugs, and herbal products).||
1757|148|P|   During pregnancy, this medication should be used only when||
1757|149|P|clearly needed. Discuss the risks and benefits with your doctor.||
1757|150|P|If you have HIV infection, treatment can lower the risk of||
1757|151|P|passing HIV infection to your baby, and this medication may be||
1757|152|P|part of that treatment.||
1757|153|P|   This medication passes into breast milk, but is unlikely to||
1757|154|P|harm a nursing infant. If you have HIV, breast milk may transmit||
1757|155|P|HIV. Consult your doctor before breastfeeding.||
1757|156|B|||
1757|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1757|158|I|medications work or increase your risk for serious side effects.||
1757|159|I|This document does not contain all possible drug interactions.||
1757|160|I|Keep a list of all the products you use (including||
1757|161|I|prescription/nonprescription drugs and herbal products) and share||
1757|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
1757|163|I|the dosage of any medicines without your doctor's approval.||
1757|164|I|   Some products that may interact with this drug are: adefovir,||
1757|165|I|orlistat, other drugs that may harm the kidneys (including||
1757|166|I|aminoglycosides such as amikacin/gentamicin).||
1757|167|I|   Tenofovir alafenamide can decrease the effectiveness of||
1757|168|I|another medication, atazanavir (by decreasing blood levels). If||
1757|169|I|you are taking atazanavir with this product, you may need to also||
1757|170|I|take another medication (ritonavir). Consult your doctor or||
1757|171|I|pharmacist for more details.||
1757|172|I|   Check the labels on all your medicines for HIV infection||
1757|173|I|because they may contain the same or similar ingredients as those||
1757|174|I|in this product (such as tenofovir alafenamide, emtricitabine,||
1757|175|I|lamivudine). Do not take medications that contain the same or||
1757|176|I|similar ingredients as this product.||
1757|177|B|||
1757|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1757|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1757|180|O|poison control center right away. US residents can call||
1757|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1757|182|B|||
1757|183|N|NOTES:  Do not share this medication with others.||
1757|184|N|   Lab and/or medical tests (such as kidney/liver function, viral||
1757|185|N|load, test for hepatitis B virus, T-cell counts, blood mineral||
1757|186|N|levels, bone density) should be done before you start taking this||
1757|187|N|medication and while you are taking it. Keep all medical and lab||
1757|188|N|appointments.||
1757|189|B|||
1757|190|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1757|191|D|remember. If it is near the time of the next dose, skip the||
1757|192|D|missed dose. Take your next dose at the regular time. Do not||
1757|193|D|double the dose to catch up.||
1757|194|B|||
1757|195|R|STORAGE:  Store in the original container at room temperature||
1757|196|R|away from light and moisture. Do not store in the bathroom. Keep||
1757|197|R|all medications away from children and pets.||
1757|198|R|   Do not flush medications down the toilet or pour them into a||
1757|199|R|drain unless instructed to do so. Properly discard this product||
1757|200|R|when it is expired or no longer needed. Consult your pharmacist||
1757|201|R|or local waste disposal company.||
1757|202|B|||
1757|203|A|Information last revised April 2025.||
1757|204|A|Copyright(c) 2025 First Databank, Inc.||
1757|205|B|||
1758|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1758|002|Z|does NOT have all possible information about this product. This||
1758|003|Z|information does not assure that this product is safe, effective,||
1758|004|Z|or appropriate for you. This information is not individual||
1758|005|Z|medical advice and does not substitute for the advice of your||
1758|006|Z|health care professional. Always ask your health care||
1758|007|Z|professional for complete information about this product and your||
1758|008|Z|specific health needs.||
1758|009|B|||
1758|010|T|RILUZOLE FILM - ORAL||
1758|011|F|(RIL-ue-zole)||
1758|012|B|||
1758|013|C|COMMON BRAND NAME(S): Exservan||
1758|014|B|||
1758|015|U|USES:  This medication is used to treat a certain type of nerve||
1758|016|U|disease called amyotrophic lateral sclerosis (ALS, also commonly||
1758|017|U|called Lou Gehrig's disease). Riluzole helps to slow down the||
1758|018|U|worsening of this disease and prolong survival.||
1758|019|B|||
1758|020|H|HOW TO USE:  Read the Instructions for Use if available from your||
1758|021|H|pharmacist before you start taking riluzole and each time you get||
1758|022|H|a refill. If you have any questions, ask your doctor or||
1758|023|H|pharmacist.||
1758|024|H|   Take this medication by mouth on an empty stomach (at least 1||
1758|025|H|hour before or 2 hours after a meal) as directed by your doctor,||
1758|026|H|usually twice daily.||
1758|027|H|   With dry hands, open the foil pouch just before use and place||
1758|028|H|the medication on top of the tongue and let it dissolve. Do not||
1758|029|H|cut the film. Do not chew, spit, talk, or drink any liquids while||
1758|030|H|the medication is dissolving. Swallow saliva normally as the||
1758|031|H|medication is dissolving.||
1758|032|H|   Use this medication regularly to get the most benefit from it.||
1758|033|H|To help you remember, take it at the same times each day.||
1758|034|H|   Do not increase your dose or use this drug more often or for||
1758|035|H|longer than prescribed. Your condition will not improve any||
1758|036|H|faster, and your risk of side effects will increase.||
1758|037|H|   Tell your doctor if your condition gets worse.||
1758|038|B|||
1758|039|S|SIDE EFFECTS:  Dizziness, drowsiness, nausea, vomiting, or||
1758|040|S|numbness/tingling around the mouth may occur. If any of these||
1758|041|S|effects last or get worse, tell your doctor or pharmacist||
1758|042|S|promptly.||
1758|043|S|   Remember that this medication has been prescribed because your||
1758|044|S|doctor has judged that the benefit to you is greater than the||
1758|045|S|risk of side effects. Many people using this medication do not||
1758|046|S|have serious side effects.||
1758|047|S|   Tell your doctor right away if you have any serious side||
1758|048|S|effects, including: fast heartbeat, signs of pancreatitis or||
1758|049|S|liver disease (nausea/vomiting that doesn't stop, loss of||
1758|050|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1758|051|S|urine), signs of infection (such as sore throat that doesn't go||
1758|052|S|away, fever, chills), signs of lung problems (such as shortness||
1758|053|S|of breath, cough).||
1758|054|S|   A very serious allergic reaction to this drug is rare.||
1758|055|S|However, get medical help right away if you notice any symptoms||
1758|056|S|of a serious allergic reaction, including: rash, itching/swelling||
1758|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1758|058|S|breathing.||
1758|059|S|   This is not a complete list of possible side effects. If you||
1758|060|S|notice other effects not listed above, contact your doctor or||
1758|061|S|pharmacist.||
1758|062|S|   In the US -||
1758|063|S|   Call your doctor for medical advice about side effects. You||
1758|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1758|065|S|www.fda.gov/medwatch.||
1758|066|S|   In Canada - Call your doctor for medical advice about side||
1758|067|S|effects. You may report side effects to Health Canada at||
1758|068|S|1-866-234-2345.||
1758|069|B|||
1758|070|P|PRECAUTIONS:  Before taking riluzole, tell your doctor or||
1758|071|P|pharmacist if you are allergic to it; or if you have any other||
1758|072|P|allergies. This product may contain inactive ingredients, which||
1758|073|P|can cause allergic reactions or other problems. Talk to your||
1758|074|P|pharmacist for more details.||
1758|075|P|   Before using this medication, tell your doctor or pharmacist||
1758|076|P|your medical history, especially of: liver disease.||
1758|077|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1758|078|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1758|079|P|machinery, or do anything that needs alertness until you can do||
1758|080|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1758|081|P|are using marijuana (cannabis).||
1758|082|P|   Before having surgery, tell your doctor or dentist about all||
1758|083|P|the products you use (including prescription drugs,||
1758|084|P|nonprescription drugs, and herbal products).||
1758|085|P|   During pregnancy, this medication should be used only when||
1758|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
1758|087|P|   It is unknown if this drug passes into breast milk. Consult||
1758|088|P|your doctor before breastfeeding.||
1758|089|B|||
1758|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1758|091|I|medications work or increase your risk for serious side effects.||
1758|092|I|This document does not contain all possible drug interactions.||
1758|093|I|Keep a list of all the products you use (such as||
1758|094|I|prescription/nonprescription drugs and herbal products) and share||
1758|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
1758|096|I|the dosage of any medicines without your doctor's approval.||
1758|097|B|||
1758|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1758|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1758|100|O|poison control center right away. US residents can call||
1758|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1758|102|O|Symptoms of overdose may include: mental/mood changes (such as||
1758|103|O|confusion, memory loss), severe drowsiness.||
1758|104|B|||
1758|105|N|NOTES:  Do not share this medication with others.||
1758|106|N|   Lab and/or medical tests (such as liver function,||
1758|107|N|amylase/lipase levels) should be done before you start taking||
1758|108|N|this medication and while you are taking it. Keep all medical and||
1758|109|N|lab appointments. Consult your doctor for more details.||
1758|110|B|||
1758|111|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1758|112|D|remember. If it is near the time of the next dose, skip the||
1758|113|D|missed dose. Take your next dose at the regular time. Do not||
1758|114|D|double the dose to catch up.||
1758|115|B|||
1758|116|R|STORAGE:  Store at room temperature away from light and moisture.||
1758|117|R|Keep the medication in the pouch until ready to use. Do not store||
1758|118|R|in the bathroom. Keep all medications away from children and||
1758|119|R|pets.||
1758|120|R|   Do not flush medications down the toilet or pour them into a||
1758|121|R|drain unless instructed to do so. Properly discard this product||
1758|122|R|when it is expired or no longer needed. Consult your pharmacist||
1758|123|R|or local waste disposal company.||
1758|124|B|||
1758|125|A|Information last revised September 2025.||
1758|126|A|Copyright(c) 2025 First Databank, Inc.||
1758|127|B|||
1759|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1759|002|Z|does NOT have all possible information about this product. This||
1759|003|Z|information does not assure that this product is safe, effective,||
1759|004|Z|or appropriate for you. This information is not individual||
1759|005|Z|medical advice and does not substitute for the advice of your||
1759|006|Z|health care professional. Always ask your health care||
1759|007|Z|professional for complete information about this product and your||
1759|008|Z|specific health needs.||
1759|009|B|||
1759|010|T|LONCASTUXIMAB TESIRINE - INJECTION||
1759|011|F|(LON-kas-TUX-i-mab TES-ir-een)||
1759|012|B|||
1759|013|C|COMMON BRAND NAME(S): Zynlonta||
1759|014|B|||
1759|015|U|USES:  Loncastuximab tesirine is used to treat a certain type of||
1759|016|U|cancer (large B-cell lymphoma). It is a chemotherapy drug that||
1759|017|U|works by slowing or stopping the growth of cancer cells.||
1759|018|B|||
1759|019|H|HOW TO USE:  This medication is given by injection into a vein as||
1759|020|H|directed by your doctor, usually once every 3 weeks. The||
1759|021|H|injection is given by a health care professional. The dosage is||
1759|022|H|based on your medical condition, weight, and response to||
1759|023|H|treatment.||
1759|024|H|   Before you receive this medication, your doctor may prescribe||
1759|025|H|other medication (such as dexamethasone) to decrease your chance||
1759|026|H|of side effects. Carefully follow your doctor's directions for||
1759|027|H|all your medications.||
1759|028|H|   If this medication accidentally leaks into tissue around the||
1759|029|H|injection site, the skin and/or muscle may be severely damaged.||
1759|030|H|Tell your doctor right away if you have irritation, redness,||
1759|031|H|swelling, or pain at the injection site.||
1759|032|B|||
1759|033|S|SIDE EFFECTS:  See also How to Use section.||
1759|034|S|   Tiredness, nausea, diarrhea or constipation, abdominal pain,||
1759|035|S|vomiting, decreased appetite, or muscle/joint pain may occur. If||
1759|036|S|any of these effects last or get worse, tell your doctor or||
1759|037|S|pharmacist promptly.||
1759|038|S|   People using this medication may have serious side effects.||
1759|039|S|However, you have been prescribed this drug because your doctor||
1759|040|S|has judged that the benefit to you is greater than the risk of||
1759|041|S|side effects. Careful monitoring by your doctor may decrease your||
1759|042|S|risk.||
1759|043|S|   Tell your doctor right away if you have any serious side||
1759|044|S|effects, including: signs of too much body fluid (such as new or||
1759|045|S|worsening swelling or puffiness, weight gain, chest pain,||
1759|046|S|shortness of breath).||
1759|047|S|   This medication decreases bone marrow function, an effect that||
1759|048|S|may lead to a low number of blood cells such as red cells, white||
1759|049|S|cells, and platelets. This effect can cause anemia, decrease your||
1759|050|S|body's ability to fight an infection, or cause easy||
1759|051|S|bruising/bleeding. Tell your doctor right away if you develop any||
1759|052|S|of the following symptoms: unusual tiredness, pale skin, signs of||
1759|053|S|infection (such as sore throat that doesn't go away, fever,||
1759|054|S|chills), easy bruising/bleeding.||
1759|055|S|   This medication can commonly cause a mild rash that is usually||
1759|056|S|not serious. However, you may not be able to tell it apart from a||
1759|057|S|rare rash that could be a sign of a severe allergic reaction. Get||
1759|058|S|medical help right away if you develop any rash.||
1759|059|S|   A very serious allergic reaction to this drug is rare.||
1759|060|S|However, get medical help right away if you notice any symptoms||
1759|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1759|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1759|063|S|breathing.||
1759|064|S|   This is not a complete list of possible side effects. If you||
1759|065|S|notice other effects not listed above, contact your doctor or||
1759|066|S|pharmacist.||
1759|067|S|   In the US -||
1759|068|S|   Call your doctor for medical advice about side effects. You||
1759|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1759|070|S|www.fda.gov/medwatch.||
1759|071|S|   In Canada - Call your doctor for medical advice about side||
1759|072|S|effects. You may report side effects to Health Canada at||
1759|073|S|1-866-234-2345.||
1759|074|B|||
1759|075|P|PRECAUTIONS:  Before receiving loncastuximab tesirine, tell your||
1759|076|P|doctor or pharmacist if you are allergic to it; or if you have||
1759|077|P|any other allergies. This product may contain inactive||
1759|078|P|ingredients, which can cause allergic reactions or other||
1759|079|P|problems. Talk to your pharmacist for more details.||
1759|080|P|   Before using this medication, tell your doctor or pharmacist||
1759|081|P|your medical history, especially of: recent/current infection,||
1759|082|P|liver disease.||
1759|083|P|   This medication may make you more sensitive to the sun. Limit||
1759|084|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1759|085|P|sunscreen and wear protective clothing when outdoors. Tell your||
1759|086|P|doctor right away if you get sunburned or have skin||
1759|087|P|blisters/redness.||
1759|088|P|   Loncastuximab tesirine can make you more likely to get||
1759|089|P|infections or may make current infections worse. Stay away from||
1759|090|P|anyone who has an infection that may easily spread (such as||
1759|091|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
1759|092|P|have been exposed to an infection or for more details.||
1759|093|P|   Tell your health care professional that you are using||
1759|094|P|loncastuximab tesirine before having any||
1759|095|P|immunizations/vaccinations. Avoid contact with people who have||
1759|096|P|recently received live vaccines (such as flu vaccine inhaled||
1759|097|P|through the nose).||
1759|098|P|   To lower the chance of getting cut, bruised, or injured, use||
1759|099|P|caution with sharp objects like razors and nail cutters, and||
1759|100|P|avoid activities such as contact sports.||
1759|101|P|   Before having surgery, tell your doctor or dentist about all||
1759|102|P|the products you use (including prescription drugs,||
1759|103|P|nonprescription drugs, and herbal products).||
1759|104|P|   Tell your doctor if you are pregnant or plan to become||
1759|105|P|pregnant. You should not become pregnant while using||
1759|106|P|loncastuximab tesirine. Loncastuximab tesirine may harm an unborn||
1759|107|P|baby. Your doctor should order a pregnancy test before you start||
1759|108|P|this medication. Women using this medication should ask about||
1759|109|P|reliable forms of birth control during treatment and for 10||
1759|110|P|months after the last dose. Men using this medication should ask||
1759|111|P|about reliable forms of birth control during treatment and for 7||
1759|112|P|months after the last dose. If you or your partner becomes||
1759|113|P|pregnant, talk to your doctor right away about the risks and||
1759|114|P|benefits of this medication.||
1759|115|P|   It is unknown if this drug passes into breast milk. Because of||
1759|116|P|the possible risk to the infant, breastfeeding is not recommended||
1759|117|P|while using this drug and for 3 months after the last dose.||
1759|118|P|Consult your doctor before breastfeeding.||
1759|119|B|||
1759|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1759|121|I|medications work or increase your risk for serious side effects.||
1759|122|I|This document does not contain all possible drug interactions.||
1759|123|I|Keep a list of all the products you use (including||
1759|124|I|prescription/nonprescription drugs and herbal products) and share||
1759|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1759|126|I|the dosage of any medicines without your doctor's approval.||
1759|127|B|||
1759|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1759|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1759|130|O|poison control center right away. US residents can call||
1759|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1759|132|B|||
1759|133|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1759|134|N|liver function) should be done while you are using this||
1759|135|N|medication. Keep all medical and lab appointments. Consult your||
1759|136|N|doctor for more details.||
1759|137|B|||
1759|138|D|MISSED DOSE:  It is important to get each dose of this medication||
1759|139|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1759|140|D|right away for a new dosing schedule.||
1759|141|B|||
1759|142|R|STORAGE:  Not applicable. This medication is given in a hospital||
1759|143|R|or clinic and will not be stored at home.||
1759|144|B|||
1759|145|M|MEDICAL ALERT:  Your condition can cause complications in a||
1759|146|M|medical emergency. For information about enrolling in MedicAlert,||
1759|147|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1759|148|B|||
1759|149|A|Information last revised May 2024.||
1759|150|A|Copyright(c) 2025 First Databank, Inc.||
1759|151|B|||
1760|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1760|002|Z|does NOT have all possible information about this product. This||
1760|003|Z|information does not assure that this product is safe, effective,||
1760|004|Z|or appropriate for you. This information is not individual||
1760|005|Z|medical advice and does not substitute for the advice of your||
1760|006|Z|health care professional. Always ask your health care||
1760|007|Z|professional for complete information about this product and your||
1760|008|Z|specific health needs.||
1760|009|B|||
1760|010|T|AMIVANTAMAB - INJECTION||
1760|011|B|||
1760|012|C|COMMON BRAND NAME(S): Rybrevant||
1760|013|B|||
1760|014|U|USES:  Amivantamab is used to treat a certain type of lung cancer||
1760|015|U|(non-small cell lung cancer - NSCLC). It works by slowing or||
1760|016|U|stopping the growth of cancer cells.||
1760|017|B|||
1760|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1760|019|H|from your pharmacist before you start using amivantamab and each||
1760|020|H|time you get a refill. If you have any questions, ask your doctor||
1760|021|H|or pharmacist.||
1760|022|H|   This medication is given by injection into a vein by a health||
1760|023|H|care professional. It is given as directed by your doctor. The||
1760|024|H|dosage and treatment schedule are based on your medical||
1760|025|H|condition, weight, and response to treatment.||
1760|026|H|   Infusion reactions may happen during the infusion of this||
1760|027|H|drug. Your doctor may prescribe other medications (such as||
1760|028|H|acetaminophen, diphenhydramine, dexamethasone) before each||
1760|029|H|treatment to help prevent these side effects. Tell your doctor||
1760|030|H|right away if you have symptoms of infusion reactions such as||
1760|031|H|nausea, vomiting, fever, chills, flushing, shortness of breath,||
1760|032|H|chest pain, or dizziness.||
1760|033|B|||
1760|034|S|SIDE EFFECTS:  See also How to Use section.||
1760|035|S|   Dry skin, tiredness, muscle/joint pain, nausea/vomiting,||
1760|036|S|diarrhea or constipation, mouth sores, abdominal pain, decreased||
1760|037|S|appetite, headache, or dizziness may occur. If any of these||
1760|038|S|effects last or get worse, tell your doctor or pharmacist||
1760|039|S|promptly.||
1760|040|S|   An alcohol-free moisturizer may help to reduce the risk of dry||
1760|041|S|skin and other skin problems. In some cases, your doctor may||
1760|042|S|prescribe antibiotics to help prevent or relieve these||
1760|043|S|conditions.||
1760|044|S|   People using this medication may have serious side effects.||
1760|045|S|However, you have been prescribed this drug because your doctor||
1760|046|S|has judged that the benefit to you is greater than the risk of||
1760|047|S|side effects. Careful monitoring by your doctor may decrease your||
1760|048|S|risk.||
1760|049|S|   Tell your doctor right away if you have any serious side||
1760|050|S|effects, including: signs of lung disease (such as fever, new or||
1760|051|S|worsening cough/shortness of breath), vision changes (such as||
1760|052|S|blurred vision), itchy/dry eyes, eye pain/redness, swelling||
1760|053|S|ankles/feet/hands, numbness/tingling of arms/legs,||
1760|054|S|redness/swelling/pain around the nails, easy bleeding/bruising.||
1760|055|S|   When used with a certain medication (lazertinib), amivantamab||
1760|056|S|may cause blood clots in the lungs or legs. Your doctor should||
1760|057|S|prescribe an anticoagulant while you are taking the 2 medications||
1760|058|S|together, especially during the first 4 months of treatment. Get||
1760|059|S|medical help right away if any of these side effects occur: chest||
1760|060|S|pain, trouble breathing, pain/swelling/warmth in the groin/calf.||
1760|061|S|   This medication can commonly cause a mild rash that is usually||
1760|062|S|not serious. However, you may not be able to tell it apart from a||
1760|063|S|rare rash that could be a sign of a severe allergic reaction. Get||
1760|064|S|medical help right away if you develop any rash.||
1760|065|S|   A very serious allergic reaction to this drug is rare.||
1760|066|S|However, get medical help right away if you notice any symptoms||
1760|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1760|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1760|069|S|breathing.||
1760|070|S|   This is not a complete list of possible side effects. If you||
1760|071|S|notice other effects not listed above, contact your doctor or||
1760|072|S|pharmacist.||
1760|073|S|   In the US -||
1760|074|S|   Call your doctor for medical advice about side effects. You||
1760|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1760|076|S|www.fda.gov/medwatch.||
1760|077|S|   In Canada - Call your doctor for medical advice about side||
1760|078|S|effects. You may report side effects to Health Canada at||
1760|079|S|1-866-234-2345.||
1760|080|B|||
1760|081|P|PRECAUTIONS:  Before receiving amivantamab, tell your doctor or||
1760|082|P|pharmacist if you are allergic to it; or if you have any other||
1760|083|P|allergies. This product may contain inactive ingredients, which||
1760|084|P|can cause allergic reactions or other problems. Talk to your||
1760|085|P|pharmacist for more details.||
1760|086|P|   Before using this medication, tell your doctor or pharmacist||
1760|087|P|your medical history.||
1760|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1760|089|P|can make you more dizzy. Do not drive, use machinery, or do||
1760|090|P|anything that needs alertness until you can do it safely. Limit||
1760|091|P|alcoholic beverages. Talk to your doctor if you are using||
1760|092|P|marijuana (cannabis).||
1760|093|P|   This medication may make you more sensitive to the sun. Limit||
1760|094|P|your time in the sun while you receive this medication and for 2||
1760|095|P|months after stopping treatment. Avoid tanning booths and||
1760|096|P|sunlamps. Use sunscreen and wear protective clothing when||
1760|097|P|outdoors. Tell your doctor right away if you get sunburned or||
1760|098|P|have skin blisters/redness.||
1760|099|P|   Before having surgery, tell your doctor or dentist about all||
1760|100|P|the products you use (including prescription drugs,||
1760|101|P|nonprescription drugs, and herbal products).||
1760|102|P|   Tell your doctor if you are pregnant or plan to become||
1760|103|P|pregnant. You should not become pregnant while using amivantamab.||
1760|104|P|Amivantamab may harm an unborn baby. Your doctor should order a||
1760|105|P|pregnancy test before you start this medication. Ask about||
1760|106|P|reliable forms of birth control while using this medication and||
1760|107|P|for 3 months after the last dose. If you become pregnant, talk to||
1760|108|P|your doctor right away about the risks and benefits of this||
1760|109|P|medication.||
1760|110|P|   It is unknown if this drug passes into breast milk. Because of||
1760|111|P|the possible risk to the infant, breastfeeding is not recommended||
1760|112|P|while using this drug and for 3 months after the last dose.||
1760|113|P|Consult your doctor before breastfeeding.||
1760|114|B|||
1760|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1760|116|I|medications work or increase your risk for serious side effects.||
1760|117|I|This document does not contain all possible drug interactions.||
1760|118|I|Keep a list of all the products you use (including||
1760|119|I|prescription/nonprescription drugs and herbal products) and share||
1760|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1760|121|I|the dosage of any medicines without your doctor's approval.||
1760|122|B|||
1760|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1760|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1760|125|O|poison control center right away. US residents can call||
1760|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1760|127|B|||
1760|128|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
1760|129|N|blood mineral levels, blood glucose levels) should be done while||
1760|130|N|you are using this medication. Keep all medical and lab||
1760|131|N|appointments. Consult your doctor for more details.||
1760|132|B|||
1760|133|D|MISSED DOSE:  It is important to get each dose of this medication||
1760|134|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1760|135|D|right away for a new dosing schedule.||
1760|136|B|||
1760|137|R|STORAGE:  Not applicable. This medication is given in a hospital||
1760|138|R|or clinic and will not be stored at home.||
1760|139|B|||
1760|140|A|Information last revised November 2025.||
1760|141|A|Copyright(c) 2025 First Databank, Inc.||
1760|142|B|||
1761|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1761|002|Z|does NOT have all possible information about this product. This||
1761|003|Z|information does not assure that this product is safe, effective,||
1761|004|Z|or appropriate for you. This information is not individual||
1761|005|Z|medical advice and does not substitute for the advice of your||
1761|006|Z|health care professional. Always ask your health care||
1761|007|Z|professional for complete information about this product and your||
1761|008|Z|specific health needs.||
1761|009|B|||
1761|010|T|MILTEFOSINE - ORAL||
1761|011|F|(mil-te-FOS-een)||
1761|012|B|||
1761|013|C|COMMON BRAND NAME(S): Impavido||
1761|014|B|||
1761|015|W|WARNING:  Women who are pregnant must not use miltefosine. It may||
1761|016|W|harm an unborn baby. Women of childbearing age must have a||
1761|017|W|negative pregnancy test before starting treatment with this||
1761|018|W|medication. To prevent pregnancy, use reliable forms of birth||
1761|019|W|control during treatment and for 5 months after stopping||
1761|020|W|miltefosine. Ask your doctor for more details.||
1761|021|B|||
1761|022|U|USES:  Miltefosine is used to treat a certain infection called||
1761|023|U|leishmaniasis. It works by stopping the growth of certain||
1761|024|U|parasites.||
1761|025|B|||
1761|026|H|HOW TO USE:  Read the Medication Guide provided by your||
1761|027|H|pharmacist before you start taking miltefosine and each time you||
1761|028|H|get a refill. If you have any questions, ask your doctor or||
1761|029|H|pharmacist.||
1761|030|H|   Take this medication by mouth with food, as directed by your||
1761|031|H|doctor, usually 2 or 3 times daily. The dosage is based on your||
1761|032|H|medical condition, weight, and response to treatment.||
1761|033|H|   Swallow the capsule whole. Do not chew, break, crush, or||
1761|034|H|dissolve the capsule.||
1761|035|H|   Antibiotics work best when the amount of medicine in your body||
1761|036|H|is kept at a constant level. Take this drug at evenly spaced||
1761|037|H|intervals.||
1761|038|H|   Continue to take this medication until the full prescribed||
1761|039|H|amount is finished, even if symptoms disappear after a few days.||
1761|040|H|Stopping the medication too early may result in a return of the||
1761|041|H|infection.||
1761|042|H|   Tell your doctor if your condition lasts or gets worse.||
1761|043|B|||
1761|044|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach/abdominal||
1761|045|S|pain, joint pain, dizziness, or drowsiness may occur. If any of||
1761|046|S|these effects last or get worse, tell your doctor or pharmacist||
1761|047|S|promptly.||
1761|048|S|   Take this medication with food to help reduce||
1761|049|S|stomach/intestinal side effects. Drink plenty of fluids to avoid||
1761|050|S|dehydration and kidney problems if vomiting or diarrhea occur.||
1761|051|S|   Remember that this medication has been prescribed because your||
1761|052|S|doctor has judged that the benefit to you is greater than the||
1761|053|S|risk of side effects. Many people using this medication do not||
1761|054|S|have serious side effects.||
1761|055|S|   Tell your doctor right away if you have any serious side||
1761|056|S|effects, including: easy bruising/bleeding, bloody/black/tarry||
1761|057|S|stool, signs of kidney problems (such as change in the amount of||
1761|058|S|urine), yellowing eyes/skin, dark urine, testicular||
1761|059|S|pain/swelling.||
1761|060|S|   Rarely, miltefosine may cause serious eye problems, even||
1761|061|S|permanent blindness, in one or both eyes. If you have a higher||
1761|062|S|chance of developing vision changes on miltefosine, your doctor||
1761|063|S|may recommend an eye exam before starting this medication. If any||
1761|064|S|eye problems occur (such as sensitivity to light, eye||
1761|065|S|pain/redness, increased tearing, blurry vision, white spot on||
1761|066|S|your eye, loss of vision), stop taking miltefosine and tell your||
1761|067|S|doctor right away. If you do not stop taking miltefosine, there||
1761|068|S|is a chance that your eyesight may become worse, or blindness can||
1761|069|S|become permanent.||
1761|070|S|   A very serious allergic reaction to this drug is rare.||
1761|071|S|However, get medical help right away if you notice any symptoms||
1761|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1761|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1761|074|S|breathing.||
1761|075|S|   This is not a complete list of possible side effects. If you||
1761|076|S|notice other effects not listed above, contact your doctor or||
1761|077|S|pharmacist.||
1761|078|S|   In the US -||
1761|079|S|   Call your doctor for medical advice about side effects. You||
1761|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1761|081|S|www.fda.gov/medwatch.||
1761|082|S|   In Canada - Call your doctor for medical advice about side||
1761|083|S|effects. You may report side effects to Health Canada at||
1761|084|S|1-866-234-2345.||
1761|085|B|||
1761|086|P|PRECAUTIONS:  Before taking miltefosine, tell your doctor or||
1761|087|P|pharmacist if you are allergic to it; or if you have any other||
1761|088|P|allergies. This product may contain inactive ingredients, which||
1761|089|P|can cause allergic reactions or other problems. Talk to your||
1761|090|P|pharmacist for more details.||
1761|091|P|   Before using this medication, tell your doctor or pharmacist||
1761|092|P|your medical history, especially of: a certain genetic disorder||
1761|093|P|(Sjogren-Larsson syndrome), kidney disease, liver disease.||
1761|094|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1761|095|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1761|096|P|machinery, or do anything that needs alertness until you can do||
1761|097|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1761|098|P|are using marijuana (cannabis).||
1761|099|P|   Before having surgery, tell your doctor or dentist about all||
1761|100|P|the products you use (including prescription drugs,||
1761|101|P|nonprescription drugs, and herbal products).||
1761|102|P|   This medication can affect fertility in males. Ask your doctor||
1761|103|P|for more details.||
1761|104|P|   This medication must not be used during pregnancy. It may harm||
1761|105|P|an unborn baby. Discuss the use of reliable forms of birth||
1761|106|P|control (such as condoms, birth control pills) with your doctor,||
1761|107|P|for use during treatment and for 5 months after stopping||
1761|108|P|treatment. If you become pregnant or think you may be pregnant,||
1761|109|P|tell your doctor right away. See also Warning section.||
1761|110|P|   Vomiting or diarrhea can make birth control pills not work||
1761|111|P|well. If you are using birth control pills and have vomiting or||
1761|112|P|diarrhea, also use reliable forms of non-hormonal backup birth||
1761|113|P|control (such as condoms, diaphragm with spermicide). Talk to||
1761|114|P|your doctor for more information and about other options.||
1761|115|P|   It is unknown if miltefosine passes into breast milk. Because||
1761|116|P|of the possible risk to the infant, breastfeeding is not||
1761|117|P|recommended while using this medication and for 5 months after||
1761|118|P|the last dose. Consult your doctor before breastfeeding.||
1761|119|B|||
1761|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1761|121|I|medications work or increase your risk for serious side effects.||
1761|122|I|This document does not contain all possible drug interactions.||
1761|123|I|Keep a list of all the products you use (including||
1761|124|I|prescription/nonprescription drugs and herbal products) and share||
1761|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1761|126|I|the dosage of any medicines without your doctor's approval.||
1761|127|B|||
1761|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1761|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1761|130|O|poison control center right away. US residents can call||
1761|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1761|132|O|Symptoms of overdose may include: severe vomiting/diarrhea.||
1761|133|B|||
1761|134|N|NOTES:  Do not share this medication with others.||
1761|135|N|   Lab and/or medical tests (such as kidney/liver function,||
1761|136|N|complete blood count) should be done while you are taking this||
1761|137|N|medication. Keep all medical and lab appointments.||
1761|138|B|||
1761|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1761|140|D|remember. If it is near the time of the next dose, skip the||
1761|141|D|missed dose. Take your next dose at the regular time. Do not||
1761|142|D|double the dose to catch up.||
1761|143|B|||
1761|144|R|STORAGE:  Store at room temperature away from light and moisture.||
1761|145|R|Do not store in the bathroom. Keep all medications away from||
1761|146|R|children and pets.||
1761|147|R|   Do not flush medications down the toilet or pour them into a||
1761|148|R|drain unless instructed to do so. Properly discard this product||
1761|149|R|when it is expired or no longer needed. Consult your pharmacist||
1761|150|R|or local waste disposal company.||
1761|151|B|||
1761|152|A|Information last revised March 2025.||
1761|153|A|Copyright(c) 2025 First Databank, Inc.||
1761|154|B|||
1762|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1762|002|Z|does NOT have all possible information about this product. This||
1762|003|Z|information does not assure that this product is safe, effective,||
1762|004|Z|or appropriate for you. This information is not individual||
1762|005|Z|medical advice and does not substitute for the advice of your||
1762|006|Z|health care professional. Always ask your health care||
1762|007|Z|professional for complete information about this product and your||
1762|008|Z|specific health needs.||
1762|009|B|||
1762|010|T|VENETOCLAX - ORAL||
1762|011|F|(ven-ET-oh-klax)||
1762|012|B|||
1762|013|C|COMMON BRAND NAME(S): Venclexta||
1762|014|B|||
1762|015|U|USES:  This medication is used to treat certain types of cancer||
1762|016|U|(chronic lymphocytic leukemia-CLL, small lymphocytic||
1762|017|U|lymphoma-SLL, acute myeloid leukemia-AML). Venetoclax is a drug||
1762|018|U|that works by helping to slow or stop the growth of cancer cells.||
1762|019|B|||
1762|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1762|021|H|pharmacist before you start taking venetoclax and each time you||
1762|022|H|get a refill. If you have any questions, ask your doctor or||
1762|023|H|pharmacist.||
1762|024|H|   To help prevent side effects, drink 6 to 8 glasses (about 56||
1762|025|H|ounces/1660 milliliters) of water each day, starting 2 days||
1762|026|H|before your first dose, on the day of your first dose, and each||
1762|027|H|time your dose is increased. Take this medication by mouth with a||
1762|028|H|meal and water as directed by your doctor, usually once daily.||
1762|029|H|Swallow the tablets whole. Do not chew, crush, or break the||
1762|030|H|tablets before swallowing.||
1762|031|H|   If you vomit soon after taking a dose, do not take another||
1762|032|H|dose on the same day. Take your next dose at the regular time.||
1762|033|H|   The dosage is based on your medical condition, response to||
1762|034|H|treatment, and other medications you may be taking. Be sure to||
1762|035|H|tell your doctor and pharmacist about all the products you use||
1762|036|H|(including prescription drugs, nonprescription drugs, and herbal||
1762|037|H|products). To reduce your risk of side effects, your doctor may||
1762|038|H|direct you to start this medication at a low dose and gradually||
1762|039|H|increase your dose. Follow your doctor's instructions carefully.||
1762|040|H|   Use this medication regularly to get the most benefit from it.||
1762|041|H|To help you remember, take it at the same time each day.||
1762|042|H|   Do not increase your dose or use this drug more often or for||
1762|043|H|longer than prescribed. Your condition will not improve any||
1762|044|H|faster, and your risk of serious side effects will increase.||
1762|045|H|   Avoid eating/drinking grapefruit products, Seville oranges||
1762|046|H|(often found in marmalade), or starfruit while using this||
1762|047|H|medication unless your doctor or pharmacist says you may do so||
1762|048|H|safely. These can increase the chance of side effects with this||
1762|049|H|medicine. Ask your doctor or pharmacist for more details.||
1762|050|B|||
1762|051|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, tiredness, or headache||
1762|052|S|may occur. Nausea and vomiting can be severe. In some cases, your||
1762|053|S|doctor may prescribe medication to prevent or relieve nausea and||
1762|054|S|vomiting. Eating several small meals, not eating before||
1762|055|S|treatment, or limiting activity may help lessen some of these||
1762|056|S|effects. If any of these effects last or get worse, tell your||
1762|057|S|doctor or pharmacist promptly.||
1762|058|S|   People using this medication may have serious side effects.||
1762|059|S|However, you have been prescribed this drug because your doctor||
1762|060|S|has judged that the benefit to you is greater than the risk of||
1762|061|S|side effects. Careful monitoring by your doctor may decrease your||
1762|062|S|risk.||
1762|063|S|   Tell your doctor right away if you have any serious side||
1762|064|S|effects, such as: easy bruising/bleeding.||
1762|065|S|   This medication may lower your ability to fight infections.||
1762|066|S|This may make you more likely to get a serious (rarely fatal)||
1762|067|S|infection or make any infection you have worse. Tell your doctor||
1762|068|S|right away if you have any signs of infection (such as sore||
1762|069|S|throat that doesn't go away, fever, chills, cough).||
1762|070|S|   Venetoclax sometimes causes side effects due to the rapid||
1762|071|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1762|072|S|risk, your doctor may add a medication and tell you to drink||
1762|073|S|plenty of fluids. Tell your doctor right away if you have||
1762|074|S|symptoms such as: low back/side pain (flank pain), signs of||
1762|075|S|kidney problems (such as painful urination, pink/bloody urine,||
1762|076|S|change in the amount of urine), muscle spasms/weakness.||
1762|077|S|   A very serious allergic reaction to this drug is rare.||
1762|078|S|However, get medical help right away if you notice any symptoms||
1762|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1762|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1762|081|S|breathing.||
1762|082|S|   This is not a complete list of possible side effects. If you||
1762|083|S|notice other effects not listed above, contact your doctor or||
1762|084|S|pharmacist.||
1762|085|S|   In the US -||
1762|086|S|   Call your doctor for medical advice about side effects. You||
1762|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1762|088|S|www.fda.gov/medwatch.||
1762|089|S|   In Canada - Call your doctor for medical advice about side||
1762|090|S|effects. You may report side effects to Health Canada at||
1762|091|S|1-866-234-2345.||
1762|092|B|||
1762|093|P|PRECAUTIONS:  Before taking venetoclax, tell your doctor or||
1762|094|P|pharmacist if you are allergic to it; or if you have any other||
1762|095|P|allergies. This product may contain inactive ingredients, which||
1762|096|P|can cause allergic reactions or other problems. Talk to your||
1762|097|P|pharmacist for more details.||
1762|098|P|   Before using this medication, tell your doctor or pharmacist||
1762|099|P|your medical history, especially of: current/recent/returning||
1762|100|P|infection, liver disease.||
1762|101|P|   Venetoclax can make you more likely to get infections or may||
1762|102|P|make current infections worse. Stay away from anyone who has an||
1762|103|P|infection that may easily spread (such as chickenpox, COVID-19,||
1762|104|P|measles, flu). Talk to your doctor if you have been exposed to an||
1762|105|P|infection or for more details.||
1762|106|P|   Tell your health care professional that you are using||
1762|107|P|venetoclax before having any immunizations/vaccinations. Avoid||
1762|108|P|contact with people who have recently received live vaccines||
1762|109|P|(such as flu vaccine inhaled through the nose).||
1762|110|P|   To lower the chance of getting cut, bruised, or injured, use||
1762|111|P|caution with sharp objects like razors and nail cutters, and||
1762|112|P|avoid activities such as contact sports.||
1762|113|P|   Before having surgery, tell your doctor or dentist about all||
1762|114|P|the products you use (including prescription drugs,||
1762|115|P|nonprescription drugs, and herbal products).||
1762|116|P|   Tell your doctor if you are pregnant or plan to become||
1762|117|P|pregnant. You should not become pregnant while using venetoclax.||
1762|118|P|Venetoclax may harm an unborn baby. Your doctor should order a||
1762|119|P|pregnancy test before you start this medication. Ask about||
1762|120|P|reliable forms of birth control while using this medication and||
1762|121|P|for at least 30 days after the last dose. If you become pregnant,||
1762|122|P|talk to your doctor right away about the risks and benefits of||
1762|123|P|this medication.||
1762|124|P|   It is unknown if this drug passes into breast milk. Because of||
1762|125|P|the possible risk to the infant, breastfeeding is not recommended||
1762|126|P|while using this drug and for 1 week after the last dose. Consult||
1762|127|P|your doctor before breastfeeding.||
1762|128|B|||
1762|129|I|DRUG INTERACTIONS:  See also How to Use section.||
1762|130|I|   Drug interactions may change how your medications work or||
1762|131|I|increase your risk for serious side effects. This document does||
1762|132|I|not contain all possible drug interactions. Keep a list of all||
1762|133|I|the products you use (including prescription/nonprescription||
1762|134|I|drugs and herbal products) and share it with your doctor and||
1762|135|I|pharmacist. Do not start, stop, or change the dosage of any||
1762|136|I|medicines without your doctor's approval.||
1762|137|I|   Other medications can affect the removal of venetoclax from||
1762|138|I|your body, which may affect how venetoclax works. Examples||
1762|139|I|include azole antifungals (such as itraconazole, ketoconazole,||
1762|140|I|posaconazole), HIV protease inhibitors (such as atazanavir)||
1762|141|I|macrolide antibiotics (such as clarithromycin, erythromycin),||
1762|142|I|rifamycins (such as rifampin, rifabutin), ritonavir, St. John's||
1762|143|I|wort, drugs used to treat seizures (such as carbamazepine,||
1762|144|I|phenytoin), among others.||
1762|145|B|||
1762|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1762|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1762|148|O|poison control center right away. US residents can call||
1762|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1762|150|B|||
1762|151|N|NOTES:  Do not share this medication with others.||
1762|152|N|   Lab and/or medical tests (such as kidney function, complete||
1762|153|N|blood counts, blood mineral levels, uric acid level) should be||
1762|154|N|done before you start taking this medication and while you are||
1762|155|N|taking it. Keep all medical and lab appointments.||
1762|156|B|||
1762|157|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1762|158|D|remember. If it is more than 8 hours after the missed dose, skip||
1762|159|D|the missed dose. Take your next dose at the regular time. Do not||
1762|160|D|double the dose to catch up.||
1762|161|B|||
1762|162|R|STORAGE:  Store in original container/package at room temperature||
1762|163|R|away from light and moisture. Do not store in the bathroom. Keep||
1762|164|R|all medications away from children and pets.||
1762|165|R|   Do not flush medications down the toilet or pour them into a||
1762|166|R|drain unless instructed to do so. Properly discard this product||
1762|167|R|when it is expired or no longer needed. Consult your pharmacist||
1762|168|R|or local waste disposal company.||
1762|169|B|||
1762|170|M|MEDICAL ALERT:  Your condition can cause complications in a||
1762|171|M|medical emergency. For information about enrolling in MedicAlert,||
1762|172|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1762|173|B|||
1762|174|A|Information last revised April 2025.||
1762|175|A|Copyright(c) 2025 First Databank, Inc.||
1762|176|B|||
1763|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1763|002|Z|does NOT have all possible information about this product. This||
1763|003|Z|information does not assure that this product is safe, effective,||
1763|004|Z|or appropriate for you. This information is not individual||
1763|005|Z|medical advice and does not substitute for the advice of your||
1763|006|Z|health care professional. Always ask your health care||
1763|007|Z|professional for complete information about this product and your||
1763|008|Z|specific health needs.||
1763|009|B|||
1763|010|T|SUMATRIPTAN POWDER - NASAL||
1763|011|F|(SOO-ma-TRIP-tan)||
1763|012|B|||
1763|013|C|COMMON BRAND NAME(S): Onzetra Xsail||
1763|014|B|||
1763|015|U|USES:  Sumatriptan is used to treat migraines. It helps to||
1763|016|U|relieve headache, pain, and other migraine symptoms (such as||
1763|017|U|nausea, vomiting, sensitivity to light/sound). Prompt treatment||
1763|018|U|helps you return to your normal routine and may decrease your||
1763|019|U|need for other pain medications. Sumatriptan belongs to a class||
1763|020|U|of drugs known as triptans. It affects a certain natural||
1763|021|U|substance (serotonin) that narrows blood vessels in the brain. It||
1763|022|U|may also relieve pain by affecting certain nerves in the brain.||
1763|023|U|   Sumatriptan does not prevent future migraines or lessen how||
1763|024|U|often you get migraine attacks.||
1763|025|B|||
1763|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1763|027|H|from your pharmacist before you start using sumatriptan and each||
1763|028|H|time you get a refill. If you have any questions, ask your doctor||
1763|029|H|or pharmacist.||
1763|030|H|   Use this medication at the first sign of a migraine as||
1763|031|H|directed by your doctor, usually 1 nosepiece in each nostril.||
1763|032|H|Follow the illustrated directions for the proper use of this||
1763|033|H|medication. Remember to blow with your mouth into the device to||
1763|034|H|deliver medication into your nose.||
1763|035|H|   If your symptoms do not get better, do not use more doses of||
1763|036|H|this medication before talking to your doctor. If your symptoms||
1763|037|H|are only partly better, or if your headache comes back, you may||
1763|038|H|use another dose at least 2 hours after the first dose. The||
1763|039|H|dosage is based on your medical condition and response to||
1763|040|H|treatment. Do not use more than 44 milligrams/4 nosepieces in a||
1763|041|H|24-hour period.||
1763|042|H|   If you have a higher risk for heart problems (see Precautions||
1763|043|H|section), your doctor may do a heart exam before you start using||
1763|044|H|sumatriptan. He/she may also direct you to use your first dose of||
1763|045|H|this medication in the office/clinic to watch for serious side||
1763|046|H|effects (such as chest pain). Talk to your doctor for details.||
1763|047|H|   If you are using drugs for migraine attacks on 10 or more days||
1763|048|H|each month, the drugs may actually make your headaches worse||
1763|049|H|(medication overuse headache). Do not use medications more often||
1763|050|H|or for longer than directed. Tell your doctor if you need to use||
1763|051|H|this medication more often, or if the medication is not working||
1763|052|H|as well, or if your headaches get worse.||
1763|053|B|||
1763|054|S|SIDE EFFECTS:  Unusual taste, runny nose, or||
1763|055|S|irritation/numbness/tingling of the nose or throat may occur||
1763|056|S|after using this medication. Flushing, feelings of||
1763|057|S|tingling/numbness/prickling/heat, tiredness, weakness,||
1763|058|S|drowsiness, or dizziness may also occur. If any of these effects||
1763|059|S|last or get worse, tell your doctor or pharmacist promptly.||
1763|060|S|   Remember that this medication has been prescribed because your||
1763|061|S|doctor has judged that the benefit to you is greater than the||
1763|062|S|risk of side effects. Many people using this medication do not||
1763|063|S|have serious side effects.||
1763|064|S|   This medication may raise your blood pressure. Check your||
1763|065|S|blood pressure regularly and tell your doctor if the results are||
1763|066|S|high.||
1763|067|S|   Tell your doctor right away if you have any serious side||
1763|068|S|effects, including: blue fingers/toes/nails, cold hands/feet,||
1763|069|S|hearing changes, mental/mood changes.||
1763|070|S|   Sumatriptan can commonly cause chest/jaw/neck tightness, pain,||
1763|071|S|or pressure that is usually not serious. However, these side||
1763|072|S|effects are like symptoms of a heart attack, which may include||
1763|073|S|chest/jaw/left arm pain, shortness of breath, or unusual||
1763|074|S|sweating. Get medical help right away if these or other serious||
1763|075|S|side effects occur, including: fast/irregular heartbeat,||
1763|076|S|fainting, severe stomach/abdominal pain, bloody diarrhea,||
1763|077|S|seizures, signs of a stroke (such as weakness on one side of the||
1763|078|S|body, trouble speaking, sudden vision changes, confusion).||
1763|079|S|   This medication may increase serotonin and rarely cause a very||
1763|080|S|serious condition called serotonin syndrome/toxicity. The risk||
1763|081|S|increases if you are also taking other drugs that increase||
1763|082|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1763|083|S|take (see Drug Interactions section). Get medical help right away||
1763|084|S|if you develop some of the following symptoms: fast heartbeat,||
1763|085|S|hallucinations, loss of coordination, severe dizziness, severe||
1763|086|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1763|087|S|unusual agitation/restlessness.||
1763|088|S|   A very serious allergic reaction to this drug is rare.||
1763|089|S|However, get medical help right away if you notice any symptoms||
1763|090|S|of a serious allergic reaction, including: rash, itching/swelling||
1763|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1763|092|S|breathing.||
1763|093|S|   This is not a complete list of possible side effects. If you||
1763|094|S|notice other effects not listed above, contact your doctor or||
1763|095|S|pharmacist.||
1763|096|S|   In the US -||
1763|097|S|   Call your doctor for medical advice about side effects. You||
1763|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1763|099|S|www.fda.gov/medwatch.||
1763|100|S|   In Canada - Call your doctor for medical advice about side||
1763|101|S|effects. You may report side effects to Health Canada at||
1763|102|S|1-866-234-2345.||
1763|103|B|||
1763|104|P|PRECAUTIONS:  Before using sumatriptan, tell your doctor or||
1763|105|P|pharmacist if you are allergic to it; or if you have any other||
1763|106|P|allergies. This product may contain inactive ingredients, which||
1763|107|P|can cause allergic reactions or other problems. Talk to your||
1763|108|P|pharmacist for more details.||
1763|109|P|   Before using this medication, tell your doctor or pharmacist||
1763|110|P|your medical history, especially of: blood circulation problems||
1763|111|P|(for example, in your legs, arms, hands, or stomach), certain||
1763|112|P|types of headaches (hemiplegic or basilar migraine), heart||
1763|113|P|problems (such as chest pain, irregular heartbeat, previous heart||
1763|114|P|attack), liver disease, seizures, stroke or "mini-stroke"||
1763|115|P|(transient ischemic attack).||
1763|116|P|   Certain conditions can increase your risk for heart problems.||
1763|117|P|Tell your doctor if you have any of these conditions, including:||
1763|118|P|high blood pressure, high cholesterol, diabetes, family history||
1763|119|P|of heart disease, overweight, smoker, postmenopausal (women), age||
1763|120|P|more than 40 years (men).||
1763|121|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1763|122|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1763|123|P|machinery, or do anything that needs alertness until you can do||
1763|124|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1763|125|P|are using marijuana (cannabis).||
1763|126|P|   Before having surgery, tell your doctor or dentist about all||
1763|127|P|the products you use (including prescription drugs,||
1763|128|P|nonprescription drugs, and herbal products).||
1763|129|P|   The risk of heart disease, liver disease, and high blood||
1763|130|P|pressure increases with age. Older adults may be more sensitive||
1763|131|P|to the side effects of this drug, especially increased blood||
1763|132|P|pressure and heart problems.||
1763|133|P|   During pregnancy, this medication should be used only when||
1763|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
1763|135|P|   This drug passes into breast milk. Consult your doctor before||
1763|136|P|breastfeeding.||
1763|137|B|||
1763|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1763|139|I|medications work or increase your risk for serious side effects.||
1763|140|I|This document does not contain all possible drug interactions.||
1763|141|I|Keep a list of all the products you use (including||
1763|142|I|prescription/nonprescription drugs and herbal products) and share||
1763|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
1763|144|I|the dosage of any medicines without your doctor's approval.||
1763|145|I|   Taking MAO inhibitors with this medication may cause a serious||
1763|146|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
1763|147|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1763|148|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1763|149|I|selegiline, tranylcypromine) during treatment with this||
1763|150|I|medication. Most MAO inhibitors should also not be taken for two||
1763|151|I|weeks before treatment with this medication. Ask your doctor when||
1763|152|I|to start or stop using this medication.||
1763|153|I|   The risk of serotonin syndrome/toxicity increases if you are||
1763|154|I|also taking other drugs that increase serotonin. Examples include||
1763|155|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1763|156|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1763|157|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1763|158|I|serotonin syndrome/toxicity may be more likely when you start or||
1763|159|I|increase the dose of these drugs.||
1763|160|I|   If you also take any ergotamine medication (such as||
1763|161|I|dihydroergotamine) or other "triptan" drugs (such as||
1763|162|I|zolmitriptan, rizatriptan), you will need to separate your||
1763|163|I|sumatriptan dose from your dose of these other medications to||
1763|164|I|lessen the chance of serious side effects. Ask your doctor how||
1763|165|I|long you should wait between your doses of these drugs.||
1763|166|B|||
1763|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1763|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1763|169|O|poison control center right away. US residents can call||
1763|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1763|171|B|||
1763|172|N|NOTES:  Do not share this medication with others.||
1763|173|N|   Certain foods, beverages, or food additives (such as red wine,||
1763|174|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
1763|175|N|patterns such as irregular eating/sleeping habits or stress may||
1763|176|N|bring on a migraine headache. Avoiding these "triggers" may help||
1763|177|N|lessen migraine attacks. Consult your doctor for more details.||
1763|178|N|   Lab and/or medical tests (such as blood pressure) may be done||
1763|179|N|while you are using this medication. Keep all medical and lab||
1763|180|N|appointments. Consult your doctor for more details.||
1763|181|B|||
1763|182|D|MISSED DOSE:  Not applicable. See How to Use section.||
1763|183|B|||
1763|184|R|STORAGE:  Store at room temperature. Keep the nosepieces in the||
1763|185|R|pouch until ready to use. Once the pouch is opened, discard any||
1763|186|R|unused nosepieces after 1 hour. Keep all medications away from||
1763|187|R|children and pets.||
1763|188|R|   Do not flush medications down the toilet or pour them into a||
1763|189|R|drain unless instructed to do so. Properly discard this product||
1763|190|R|when it is expired or no longer needed. Consult your pharmacist||
1763|191|R|or local waste disposal company.||
1763|192|B|||
1763|193|A|Information last revised September 2024.||
1763|194|A|Copyright(c) 2025 First Databank, Inc.||
1763|195|B|||
1764|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1764|002|Z|does NOT have all possible information about this product. This||
1764|003|Z|information does not assure that this product is safe, effective,||
1764|004|Z|or appropriate for you. This information is not individual||
1764|005|Z|medical advice and does not substitute for the advice of your||
1764|006|Z|health care professional. Always ask your health care||
1764|007|Z|professional for complete information about this product and your||
1764|008|Z|specific health needs.||
1764|009|B|||
1764|010|T|OXYCODONE EXTENDED-RELEASE CAPSULE - ORAL||
1764|011|F|(OX-i-KOE-done)||
1764|012|B|||
1764|013|C|COMMON BRAND NAME(S): Xtampza ER||
1764|014|B|||
1764|015|W|WARNING:  Oxycodone has a risk for abuse and addiction, which can||
1764|016|W|lead to overdose and death. Oxycodone may also cause severe,||
1764|017|W|possibly fatal, breathing problems. To lower your risk, your||
1764|018|W|doctor should have you take the smallest dose of oxycodone that||
1764|019|W|works, and take it for the shortest possible time. See also How||
1764|020|W|to Use section for more information about addiction.||
1764|021|W|   Ask your doctor or pharmacist if you should have medication||
1764|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1764|023|W|Teach your family or household members about the signs of an||
1764|024|W|opioid overdose and how to treat it.||
1764|025|W|   The risk for severe breathing problems is higher when you||
1764|026|W|start this medication and after a dose increase, or if you take||
1764|027|W|the wrong dose/strength. Taking this medication with alcohol or||
1764|028|W|other drugs that can cause drowsiness or breathing problems may||
1764|029|W|cause very serious side effects, including death. Also, other||
1764|030|W|medications can affect the removal of oxycodone from your body,||
1764|031|W|which may affect how oxycodone works. Be sure you know how to||
1764|032|W|take oxycodone and what other drugs you should avoid taking with||
1764|033|W|it. See also Drug Interactions section. Get medical help right||
1764|034|W|away if any of these very serious side effects occur:||
1764|035|W|slow/shallow breathing, unusual lightheadedness, severe||
1764|036|W|drowsiness/dizziness, difficulty waking up.||
1764|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1764|038|W|or abuse. If someone accidentally swallows this drug, get medical||
1764|039|W|help right away.||
1764|040|W|   Before using this medication, women of childbearing age should||
1764|041|W|talk with their doctor(s) about the risks and benefits. Tell your||
1764|042|W|doctor if you are pregnant or if you plan to become pregnant.||
1764|043|W|During pregnancy, this medication should be used only when||
1764|044|W|clearly needed. It may slightly increase the risk of birth||
1764|045|W|defects if used during the first two months of pregnancy. Also,||
1764|046|W|using it for a long time or in high doses near the expected||
1764|047|W|delivery date may harm the unborn baby. To lessen the risk, take||
1764|048|W|the smallest effective dose for the shortest possible time.||
1764|049|W|Babies born to mothers who use this drug for a long time may||
1764|050|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1764|051|W|doctor right away if you notice any symptoms in your newborn baby||
1764|052|W|such as crying that doesn't stop, slow/shallow breathing,||
1764|053|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1764|054|W|difficulty gaining weight.||
1764|055|B|||
1764|056|U|USES:  This medication is used to help relieve severe ongoing||
1764|057|U|pain (such as due to cancer). Oxycodone belongs to a class of||
1764|058|U|drugs known as opioid analgesics. It works in the brain to change||
1764|059|U|how your body feels and responds to pain.||
1764|060|U|   Higher doses of this drug (more than 36 milligrams per dose or||
1764|061|U|72 milligrams per day) should be used only if you have been||
1764|062|U|regularly taking moderate to large amounts of an opioid||
1764|063|U|medication. These doses may cause overdose (even death) if taken||
1764|064|U|by a person who has not been regularly taking opioids.||
1764|065|U|   Do not use the extended-release form of oxycodone to relieve||
1764|066|U|pain that is mild or that will go away in a few days. This||
1764|067|U|medication is not for occasional ("as needed") use.||
1764|068|B|||
1764|069|H|HOW TO USE:  See also Warning section.||
1764|070|H|   Read the Medication Guide provided by your pharmacist before||
1764|071|H|you start taking extended-release oxycodone and each time you get||
1764|072|H|a refill. If you have any questions, ask your doctor or||
1764|073|H|pharmacist.||
1764|074|H|   Take this medication on a regular schedule as directed by your||
1764|075|H|doctor, not as needed for sudden (breakthrough) pain. Take this||
1764|076|H|drug with food, usually every 12 hours. Since food can affect the||
1764|077|H|amount of drug that is absorbed, take this medication with around||
1764|078|H|the same amount of food each time. If you have nausea, ask your||
1764|079|H|doctor or pharmacist about ways to decrease nausea (such as lying||
1764|080|H|down for 1 to 2 hours with as little head movement as possible).||
1764|081|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
1764|082|H|   If you have trouble swallowing the capsules, the capsule may||
1764|083|H|be opened and the contents sprinkled on a spoonful of soft food||
1764|084|H|(such as applesauce, yogurt). Swallow all of the drug/food||
1764|085|H|mixture right away without chewing. Then rinse your mouth and||
1764|086|H|swallow the rinse liquid to make sure that you have swallowed all||
1764|087|H|of the dose. Do not chew the mixture or prepare a supply in||
1764|088|H|advance. Another way to take the capsule is to open the capsule||
1764|089|H|and sprinkle the contents into a cup. Then pour the contents||
1764|090|H|directly in your mouth and swallow.||
1764|091|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1764|092|H|using this medication unless your doctor or pharmacist says you||
1764|093|H|may do so safely. Grapefruit can increase the chance of side||
1764|094|H|effects with this medicine. Ask your doctor or pharmacist for||
1764|095|H|more details.||
1764|096|H|   The dosage is based on your medical condition and response to||
1764|097|H|treatment. Do not increase your dose or use this drug more often||
1764|098|H|or for longer than prescribed, because your risk of side effects||
1764|099|H|may increase. Properly stop the medication when so directed.||
1764|100|H|   Before you start taking this medication, ask your doctor or||
1764|101|H|pharmacist if you should stop or change how you use your other||
1764|102|H|opioid medication(s). Other pain relievers (such as||
1764|103|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1764|104|H|or pharmacist about using oxycodone safely with other drugs.||
1764|105|H|   Suddenly stopping this medication may cause withdrawal,||
1764|106|H|especially if you have used it for a long time or in high doses.||
1764|107|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1764|108|H|Tell your doctor or pharmacist right away if you have any||
1764|109|H|withdrawal symptoms such as restlessness, mental/mood changes||
1764|110|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1764|111|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1764|112|H|aches, or sudden changes in behavior.||
1764|113|H|   When this medication is used for a long time, it may not work||
1764|114|H|as well. Talk with your doctor if this medication stops working||
1764|115|H|well.||
1764|116|H|   Though it helps many people, this medication may sometimes||
1764|117|H|cause addiction. This risk may be higher if you have a||
1764|118|H|mental/mood disorder or a substance use disorder (such as overuse||
1764|119|H|of or addiction to drugs/alcohol). Take this medication exactly||
1764|120|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1764|121|H|pharmacist for more details.||
1764|122|H|   Tell your doctor if your pain does not get better or if it||
1764|123|H|gets worse, or if you have any new pain.||
1764|124|B|||
1764|125|S|SIDE EFFECTS:  See also Warning section.||
1764|126|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
1764|127|S|drowsiness may occur. Some of these side effects may decrease||
1764|128|S|after you have been using this medication for a while. If any of||
1764|129|S|these effects last or get worse, tell your doctor or pharmacist||
1764|130|S|promptly.||
1764|131|S|   To prevent constipation, eat dietary fiber, drink enough||
1764|132|S|water, and exercise. You may also need to take a laxative. Ask||
1764|133|S|your pharmacist which type of laxative is right for you.||
1764|134|S|   To reduce the risk of dizziness and lightheadedness, get up||
1764|135|S|slowly when rising from a sitting or lying position.||
1764|136|S|   Remember that this medication has been prescribed because your||
1764|137|S|doctor has judged that the benefit to you is greater than the||
1764|138|S|risk of side effects. Many people using this medication do not||
1764|139|S|have serious side effects.||
1764|140|S|   Tell your doctor right away if you have any serious side||
1764|141|S|effects, including: interrupted breathing during sleep (sleep||
1764|142|S|apnea), mental/mood changes (such as agitation, confusion,||
1764|143|S|hallucinations), severe stomach/abdominal pain, difficulty||
1764|144|S|urinating, signs of your adrenal glands not working well (such as||
1764|145|S|loss of appetite, unusual tiredness, weight loss), trouble||
1764|146|S|swallowing.||
1764|147|S|   Get medical help right away if you have any very serious side||
1764|148|S|effects, including: fainting, seizure, slow/shallow breathing,||
1764|149|S|severe drowsiness/difficulty waking up.||
1764|150|S|   A very serious allergic reaction to this drug is rare.||
1764|151|S|However, get medical help right away if you notice any symptoms||
1764|152|S|of a serious allergic reaction, including: rash, itching/swelling||
1764|153|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1764|154|S|breathing.||
1764|155|S|   This is not a complete list of possible side effects. If you||
1764|156|S|notice other effects not listed above, contact your doctor or||
1764|157|S|pharmacist.||
1764|158|S|   In the US -||
1764|159|S|   Call your doctor for medical advice about side effects. You||
1764|160|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1764|161|S|www.fda.gov/medwatch.||
1764|162|S|   In Canada - Call your doctor for medical advice about side||
1764|163|S|effects. You may report side effects to Health Canada at||
1764|164|S|1-866-234-2345.||
1764|165|B|||
1764|166|P|PRECAUTIONS:  Before taking oxycodone, tell your doctor or||
1764|167|P|pharmacist if you are allergic to it; or to other opioid pain||
1764|168|P|relievers (such as oxymorphone); or if you have any other||
1764|169|P|allergies. This product may contain inactive ingredients, which||
1764|170|P|can cause allergic reactions or other problems. Talk to your||
1764|171|P|pharmacist for more details.||
1764|172|P|   Before using this medication, tell your doctor or pharmacist||
1764|173|P|your medical history, especially of: brain disorders (such as||
1764|174|P|head injury, tumor, seizures), breathing problems (such as||
1764|175|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1764|176|P|gallbladder disease, kidney disease, liver disease, mental/mood||
1764|177|P|disorders (such as confusion, depression), personal or family||
1764|178|P|history of a substance use disorder (such as overuse of or||
1764|179|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
1764|180|P|blockage, constipation, diarrhea due to infection, paralytic||
1764|181|P|ileus), disease of the pancreas (pancreatitis), difficulty||
1764|182|P|urinating (such as due to enlarged prostate).||
1764|183|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1764|184|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1764|185|P|machinery, or do anything that needs alertness until you can do||
1764|186|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1764|187|P|are using marijuana (cannabis).||
1764|188|P|   Before having surgery, tell your doctor or dentist about all||
1764|189|P|the products you use (including prescription drugs,||
1764|190|P|nonprescription drugs, and herbal products).||
1764|191|P|   Older adults may be more sensitive to the side effects of this||
1764|192|P|drug, especially confusion, dizziness, drowsiness, and||
1764|193|P|slow/shallow breathing.||
1764|194|P|   During pregnancy, this medication should be used only when||
1764|195|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1764|196|P|benefits with your doctor. (See also Warning section.)||
1764|197|P|   This drug passes into breast milk and may have undesirable||
1764|198|P|effects on a nursing infant. Tell the doctor right away if your||
1764|199|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1764|200|P|breathing. Consult your doctor before breastfeeding.||
1764|201|B|||
1764|202|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
1764|203|I|   Drug interactions may change how your medications work or||
1764|204|I|increase your risk for serious side effects. This document does||
1764|205|I|not contain all possible drug interactions. Keep a list of all||
1764|206|I|the products you use (including prescription/nonprescription||
1764|207|I|drugs and herbal products) and share it with your doctor and||
1764|208|I|pharmacist. Do not start, stop, or change the dosage of any||
1764|209|I|medicines without your doctor's approval.||
1764|210|I|   Some products that may interact with this drug are: certain||
1764|211|I|pain medications (mixed opioid agonist/antagonists such as||
1764|212|I|butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.||
1764|213|I|   Other medications can affect the removal of oxycodone from||
1764|214|I|your body, which may affect how oxycodone works. Examples include||
1764|215|I|azole antifungals (such as ketoconazole), macrolide antibiotics||
1764|216|I|(such as erythromycin), mifepristone, HIV medications (such as||
1764|217|I|tipranavir), rifamycins (such as rifabutin, rifampin), ritonavir,||
1764|218|I|certain drugs used to treat seizures (such as carbamazepine,||
1764|219|I|phenytoin), among others.||
1764|220|I|   The risk of serious side effects (such as slow/shallow||
1764|221|I|breathing, severe drowsiness/dizziness) may be increased if this||
1764|222|I|medication is taken with other products that may also cause||
1764|223|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1764|224|I|if you are taking other products such as other opioid pain or||
1764|225|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1764|226|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1764|227|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1764|228|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1764|229|I|cetirizine, diphenhydramine).||
1764|230|I|   Check the labels on all your medicines (such as allergy or||
1764|231|I|cough-and-cold products) because they may contain ingredients||
1764|232|I|that cause drowsiness. Ask your pharmacist about using those||
1764|233|I|products safely.||
1764|234|I|   This medication may interfere with certain lab tests (such as||
1764|235|I|amylase/lipase levels), possibly causing false test results. Make||
1764|236|I|sure lab personnel and all your doctors know you use this drug.||
1764|237|B|||
1764|238|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1764|239|O|as passing out or trouble breathing, give them naloxone or||
1764|240|O|nalmefene if available, then call 911. If the person is awake and||
1764|241|O|has no symptoms, call a poison control center right away. US||
1764|242|O|residents can call 1-800-222-1222. Canada residents can call||
1764|243|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1764|244|O|breathing, slow heartbeat, coma.||
1764|245|B|||
1764|246|N|NOTES:  Do not share this medication with others. Sharing it is||
1764|247|N|against the law.||
1764|248|N|   This medication has been prescribed for your current condition||
1764|249|N|only. Do not use it later for another condition unless your||
1764|250|N|doctor directs you to do so. A different medication may be||
1764|251|N|necessary in that case.||
1764|252|B|||
1764|253|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1764|254|D|If it is near the time of the next dose, skip the missed dose.||
1764|255|D|Take your next dose at the regular time. Do not double the dose||
1764|256|D|to catch up.||
1764|257|B|||
1764|258|R|STORAGE:  Store at room temperature away from light and moisture.||
1764|259|R|Do not store in the bathroom. Keep all medications away from||
1764|260|R|children and pets. See also Warning section.||
1764|261|R|   Do not flush medications down the toilet or pour them into a||
1764|262|R|drain unless instructed to do so. Properly discard this product||
1764|263|R|when it is expired or no longer needed. For more details, read||
1764|264|R|the Medication Guide, or consult your pharmacist or local waste||
1764|265|R|disposal company.||
1764|266|B|||
1764|267|A|Information last revised August 2025.||
1764|268|A|Copyright(c) 2025 First Databank, Inc.||
1764|269|B|||
1765|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1765|002|Z|does NOT have all possible information about this product. This||
1765|003|Z|information does not assure that this product is safe, effective,||
1765|004|Z|or appropriate for you. This information is not individual||
1765|005|Z|medical advice and does not substitute for the advice of your||
1765|006|Z|health care professional. Always ask your health care||
1765|007|Z|professional for complete information about this product and your||
1765|008|Z|specific health needs.||
1765|009|B|||
1765|010|T|PIMAVANSERIN - ORAL||
1765|011|F|(PIM-a-VAN-ser-in)||
1765|012|B|||
1765|013|C|COMMON BRAND NAME(S): Nuplazid||
1765|014|B|||
1765|015|W|WARNING:  There may be a slightly increased risk of serious,||
1765|016|W|possibly fatal side effects (such as stroke, heart failure,||
1765|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1765|018|W|by older adults with dementia. This medication should only be||
1765|019|W|used to treat a certain mental/mood disorder (psychosis) due to||
1765|020|W|Parkinson's disease. Talk with the doctor about the risks and||
1765|021|W|benefits of treatment with this medication.||
1765|022|B|||
1765|023|U|USES:  This medication is used to treat the symptoms of a certain||
1765|024|U|mental/mood disorder (psychosis) that might occur with||
1765|025|U|Parkinson's disease. Pimavanserin belongs to a class of drugs||
1765|026|U|known as atypical antipsychotics. It works by helping to restore||
1765|027|U|the balance of certain natural substances in the brain.||
1765|028|B|||
1765|029|H|HOW TO USE:  Take this medication by mouth with or without food||
1765|030|H|as directed by your doctor, usually once daily.||
1765|031|H|   If you have trouble swallowing the capsule, it may be opened||
1765|032|H|and the contents mixed in a tablespoonful (15 milliliters) of||
1765|033|H|applesauce, yogurt, pudding, or a liquid nutritional supplement.||
1765|034|H|Eat/drink the mixture right away, without chewing it. Do not save||
1765|035|H|the mixture for future use.||
1765|036|H|   Take this medication regularly to get the most benefit from||
1765|037|H|it. To help you remember, take it at the same time each day.||
1765|038|H|   The dosage is based on other medications you may be taking. Be||
1765|039|H|sure to tell your doctor and pharmacist about all the products||
1765|040|H|you use (including prescription drugs, nonprescription drugs, and||
1765|041|H|herbal products).||
1765|042|H|   Tell your doctor if your condition gets worse.||
1765|043|B|||
1765|044|S|SIDE EFFECTS:  Swelling ankles/feet/hands, confusion, or nausea||
1765|045|S|may occur. If any of these effects last or get worse, tell your||
1765|046|S|doctor or pharmacist promptly.||
1765|047|S|   Remember that this medication has been prescribed because your||
1765|048|S|doctor has judged that the benefit to you is greater than the||
1765|049|S|risk of side effects. Many people using this medication do not||
1765|050|S|have serious side effects.||
1765|051|S|   Get medical help right away if you have any very serious side||
1765|052|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1765|053|S|fainting.||
1765|054|S|   A very serious allergic reaction to this drug is rare.||
1765|055|S|However, get medical help right away if you notice any symptoms||
1765|056|S|of a serious allergic reaction, including: rash, itching/swelling||
1765|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1765|058|S|breathing.||
1765|059|S|   This is not a complete list of possible side effects. If you||
1765|060|S|notice other effects not listed above, contact your doctor or||
1765|061|S|pharmacist.||
1765|062|S|   In the US -||
1765|063|S|   Call your doctor for medical advice about side effects. You||
1765|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1765|065|S|www.fda.gov/medwatch.||
1765|066|S|   In Canada - Call your doctor for medical advice about side||
1765|067|S|effects. You may report side effects to Health Canada at||
1765|068|S|1-866-234-2345.||
1765|069|B|||
1765|070|P|PRECAUTIONS:  Before taking pimavanserin, tell your doctor or||
1765|071|P|pharmacist if you are allergic to it; or if you have any other||
1765|072|P|allergies. This product may contain inactive ingredients, which||
1765|073|P|can cause allergic reactions or other problems. Talk to your||
1765|074|P|pharmacist for more details.||
1765|075|P|   Before using this medication, tell your doctor or pharmacist||
1765|076|P|your medical history, especially of: kidney disease.||
1765|077|P|   Pimavanserin may cause a condition that affects the heart||
1765|078|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1765|079|P|serious (rarely fatal) fast/irregular heartbeat and other||
1765|080|P|symptoms (such as severe dizziness, fainting) that need medical||
1765|081|P|attention right away.||
1765|082|P|   The risk of QT prolongation may be increased if you have||
1765|083|P|certain medical conditions or are taking other drugs that may||
1765|084|P|cause QT prolongation. Before using pimavanserin, tell your||
1765|085|P|doctor or pharmacist of all the drugs you take and if you have||
1765|086|P|any of the following conditions: certain heart problems (heart||
1765|087|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1765|088|P|history of certain heart problems (QT prolongation in the EKG,||
1765|089|P|sudden cardiac death).||
1765|090|P|   Low levels of potassium or magnesium in the blood may also||
1765|091|P|increase your risk of QT prolongation. This risk may increase if||
1765|092|P|you use certain drugs (such as diuretics/"water pills") or if you||
1765|093|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1765|094|P|   Before having surgery, tell your doctor or dentist about all||
1765|095|P|the products you use (including prescription drugs,||
1765|096|P|nonprescription drugs, and herbal products).||
1765|097|P|   Older adults may be more sensitive to the side effects of this||
1765|098|P|drug, especially QT prolongation (see above).||
1765|099|P|   During pregnancy, this medication should be used only when||
1765|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
1765|101|P|   It is unknown if this medication passes into breast milk.||
1765|102|P|Consult your doctor before breastfeeding.||
1765|103|B|||
1765|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1765|105|I|medications work or increase your risk for serious side effects.||
1765|106|I|This document does not contain all possible drug interactions.||
1765|107|I|Keep a list of all the products you use (including||
1765|108|I|prescription/nonprescription drugs and herbal products) and share||
1765|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
1765|110|I|the dosage of any medicines without your doctor's approval.||
1765|111|I|   Many drugs besides pimavanserin may affect the heart rhythm||
1765|112|I|(QT prolongation), including amiodarone, chlorpromazine,||
1765|113|I|disopyramide, moxifloxacin, procainamide, quinidine, sotalol,||
1765|114|I|thioridazine, ziprasidone, among others.||
1765|115|I|   Other medications can affect the removal of pimavanserin from||
1765|116|I|your body, which may affect how pimavanserin works. Examples||
1765|117|I|include efavirenz, rifamycins (such as rifampin/rifabutin), St.||
1765|118|I|John's wort, drugs used to treat seizures (such as carbamazepine,||
1765|119|I|phenytoin), among others.||
1765|120|B|||
1765|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1765|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1765|123|O|poison control center right away. US residents can call||
1765|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1765|125|B|||
1765|126|N|NOTES:  Do not share this medication with others.||
1765|127|B|||
1765|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1765|129|D|remember. If it is near the time of the next dose, skip the||
1765|130|D|missed dose. Take your next dose at the regular time. Do not||
1765|131|D|double the dose to catch up.||
1765|132|B|||
1765|133|R|STORAGE:  Store at room temperature away from light and moisture.||
1765|134|R|Do not store in the bathroom. Keep all medications away from||
1765|135|R|children and pets.||
1765|136|R|   Do not flush medications down the toilet or pour them into a||
1765|137|R|drain unless instructed to do so. Properly discard this product||
1765|138|R|when it is expired or no longer needed. Consult your pharmacist||
1765|139|R|or local waste disposal company.||
1765|140|B|||
1765|141|A|Information last revised May 2024.||
1765|142|A|Copyright(c) 2025 First Databank, Inc.||
1765|143|B|||
1767|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1767|002|Z|does NOT have all possible information about this product. This||
1767|003|Z|information does not assure that this product is safe, effective,||
1767|004|Z|or appropriate for you. This information is not individual||
1767|005|Z|medical advice and does not substitute for the advice of your||
1767|006|Z|health care professional. Always ask your health care||
1767|007|Z|professional for complete information about this product and your||
1767|008|Z|specific health needs.||
1767|009|B|||
1767|010|T|FLUOROURACIL/SALICYLIC ACID - TOPICAL||
1767|011|F|(FLOOR-oh-URE-a-sil/SAL-i-SIL-ik AS-id)||
1767|012|B|||
1767|013|U|USES:  This medication is used to treat certain skin growths on||
1767|014|U|the face, forehead, or balding scalp of adults. These skin||
1767|015|U|growths are caused by too much sun exposure, and if not treated,||
1767|016|U|may turn into skin cancer. Fluorouracil is a chemotherapy drug||
1767|017|U|that works by slowing or stopping the growth of cancer cells.||
1767|018|U|Salicylic acid works by softening the top layer of skin which||
1767|019|U|helps fluorouracil work better. Salicylic acid belongs to the||
1767|020|U|same class of drugs as aspirin (salicylates).||
1767|021|B|||
1767|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1767|023|H|from your pharmacist before you start using this medication and||
1767|024|H|each time you get a refill. If you have any questions, ask your||
1767|025|H|doctor or pharmacist.||
1767|026|H|   Using the brush applicator provided, apply a thin film of this||
1767|027|H|medication as directed by your doctor on the clean, dry skin||
1767|028|H|growth, usually once daily. Let the solution dry to form a film||
1767|029|H|layer. Do not remove this film layer until it is time for the||
1767|030|H|next application. Do not cover the area with a dressing. Wash||
1767|031|H|your hands before and after using this medication.||
1767|032|H|   Use this medication until the skin growth has completely||
1767|033|H|cleared or for up to 12 weeks as directed. You may see||
1767|034|H|improvement as early as 6 weeks after starting treatment, but it||
1767|035|H|may take up to 8 weeks after stopping treatment to see complete||
1767|036|H|healing.||
1767|037|H|   Do not get this medication in your eyes, nose, mouth, or on||
1767|038|H|your genitals. If you do get the medication in these areas, rinse||
1767|039|H|with plenty of water.||
1767|040|H|   Avoid getting this medication on your clothes, on fabrics, or||
1767|041|H|on acrylic bathtubs since it may permanently stain them.||
1767|042|H|   This medication may cause serious harm (even death) in pets.||
1767|043|H|Keep this medication securely away from pets, and do not allow||
1767|044|H|pets to lick the area where the medication was applied. Contact||
1767|045|H|your vet right away if your pet comes into contact with this||
1767|046|H|medication.||
1767|047|H|   Do not apply more of this medication or use it more often or||
1767|048|H|for longer than prescribed. Your condition will not improve any||
1767|049|H|faster, and your risk of side effects will increase.||
1767|050|H|   Tell your doctor if your condition lasts or gets worse.||
1767|051|B|||
1767|052|S|SIDE EFFECTS:  Skin irritation, burning, redness, peeling, pain,||
1767|053|S|swelling, or changes in skin color near the treated area may||
1767|054|S|occur. If any of these effects last or get worse, tell your||
1767|055|S|doctor or pharmacist promptly. Your doctor may direct you to use||
1767|056|S|this medication less often if you have side effects.||
1767|057|S|   Remember that this medication has been prescribed because your||
1767|058|S|doctor has judged that the benefit to you is greater than the||
1767|059|S|risk of side effects. Many people using this medication do not||
1767|060|S|have serious side effects.||
1767|061|S|   Tell your doctor right away if you have any serious side||
1767|062|S|effects, including: ringing in the ears, fast breathing, fast||
1767|063|S|heartbeat, confusion, unusual tiredness.||
1767|064|S|   Stop using this medication, wash the treated area with warm||
1767|065|S|water, and get medical help right away if you have any very||
1767|066|S|serious side effects, including: nausea, vomiting, diarrhea,||
1767|067|S|mouth sores, stomach/abdominal pain, black/bloody stools, vomit||
1767|068|S|that looks like coffee grounds, signs of infection (such as sore||
1767|069|S|throat that doesn't go away, fever, chills), easy||
1767|070|S|bruising/bleeding.||
1767|071|S|   A very serious allergic reaction to this drug is rare.||
1767|072|S|However, get medical help right away if you notice any symptoms||
1767|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1767|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1767|075|S|breathing.||
1767|076|S|   This is not a complete list of possible side effects. If you||
1767|077|S|notice other effects not listed above, contact your doctor or||
1767|078|S|pharmacist.||
1767|079|S|   In the US -||
1767|080|S|   Call your doctor for medical advice about side effects. You||
1767|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1767|082|S|www.fda.gov/medwatch.||
1767|083|S|   In Canada - Call your doctor for medical advice about side||
1767|084|S|effects. You may report side effects to Health Canada at||
1767|085|S|1-866-234-2345.||
1767|086|B|||
1767|087|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1767|088|P|pharmacist if you are allergic to fluorouracil or salicylic acid;||
1767|089|P|or to flucytosine, capecitabine, or other salicylates (such as||
1767|090|P|aspirin); or if you have any other allergies. This product may||
1767|091|P|contain inactive ingredients, which can cause allergic reactions||
1767|092|P|or other problems. Talk to your pharmacist for more details.||
1767|093|P|   Before using this medication, tell your doctor or pharmacist||
1767|094|P|your medical history, especially of: a certain enzyme deficiency||
1767|095|P|(dihydropyrimidine dehydrogenase - DPD), kidney disease, problems||
1767|096|P|sensing touch/pain/temperature on your skin (such as nerve damage||
1767|097|P|caused by diabetes).||
1767|098|P|   This medication makes the treated skin area more sensitive to||
1767|099|P|the sun. Limit your time in the sun. Avoid tanning booths and||
1767|100|P|sunlamps. Use sunscreen and wear protective clothing when||
1767|101|P|outdoors. Tell your doctor right away if you get sunburned or||
1767|102|P|have skin blisters/redness.||
1767|103|P|   This medication must not be used during pregnancy. It may harm||
1767|104|P|an unborn baby. Discuss the use of reliable forms of birth||
1767|105|P|control (such as condoms, birth control pills) with your doctor.||
1767|106|P|If you become pregnant or think you may be pregnant, tell your||
1767|107|P|doctor right away.||
1767|108|P|   It is unknown if this medication passes into breast milk.||
1767|109|P|Because of the possible risk to the infant, breastfeeding is not||
1767|110|P|recommended while using this medication. Consult your doctor||
1767|111|P|before breastfeeding.||
1767|112|B|||
1767|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1767|114|I|medications work or increase your risk for serious side effects.||
1767|115|I|This document does not contain all possible drug interactions.||
1767|116|I|Keep a list of all the products you use (including||
1767|117|I|prescription/nonprescription drugs and herbal products) and share||
1767|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
1767|119|I|the dosage of any medicines without your doctor's approval.||
1767|120|B|||
1767|121|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1767|122|O|has overdosed and has serious symptoms such as passing out or||
1767|123|O|trouble breathing, call 911. Otherwise, call a poison control||
1767|124|O|center right away. US residents can call 1-800-222-1222. Canada||
1767|125|O|residents can call 1-844-764-7669.||
1767|126|B|||
1767|127|N|NOTES:  Do not share this medication with others.||
1767|128|B|||
1767|129|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1767|130|D|If it is near the time of the next dose, skip the missed dose.||
1767|131|D|Use your next dose at the regular time. Do not double the dose to||
1767|132|D|catch up.||
1767|133|B|||
1767|134|R|STORAGE:  Store at room temperature. Do not refrigerate or||
1767|135|R|freeze. This product is flammable. Keep it away from heat and||
1767|136|R|open flame. Do not use if there are crystals in the solution.||
1767|137|R|Once the bottle is opened, this medication expires after 3||
1767|138|R|months. Keep all medications away from children and pets.||
1767|139|R|   Do not flush medications down the toilet or pour them into a||
1767|140|R|drain unless instructed to do so. Properly discard this product||
1767|141|R|when it is expired or no longer needed. Consult your pharmacist||
1767|142|R|or local waste disposal company.||
1767|143|B|||
1767|144|A|Information last revised July 2025.||
1767|145|A|Copyright(c) 2025 First Databank, Inc.||
1767|146|B|||
1768|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1768|002|Z|does NOT have all possible information about this product. This||
1768|003|Z|information does not assure that this product is safe, effective,||
1768|004|Z|or appropriate for you. This information is not individual||
1768|005|Z|medical advice and does not substitute for the advice of your||
1768|006|Z|health care professional. Always ask your health care||
1768|007|Z|professional for complete information about this product and your||
1768|008|Z|specific health needs.||
1768|009|B|||
1768|010|T|BRIVARACETAM - ORAL||
1768|011|F|(BRIV-a-RA-se-tam)||
1768|012|B|||
1768|013|C|COMMON BRAND NAME(S): Briviact||
1768|014|B|||
1768|015|U|USES:  Brivaracetam is used to treat seizures (epilepsy).||
1768|016|B|||
1768|017|H|HOW TO USE:  Read the Medication Guide provided by your||
1768|018|H|pharmacist before you start taking brivaracetam and each time you||
1768|019|H|get a refill. If you have any questions, ask your doctor or||
1768|020|H|pharmacist.||
1768|021|H|   Take this medication by mouth with or without food as directed||
1768|022|H|by your doctor, usually twice daily. The dosage is based on your||
1768|023|H|medical condition, response to treatment, and other medications||
1768|024|H|you may be taking. Children's dosage is also based on age and||
1768|025|H|weight. Be sure to tell your doctor and pharmacist about all the||
1768|026|H|products you use (including prescription drugs, nonprescription||
1768|027|H|drugs, and herbal products).||
1768|028|H|   Swallow the tablet whole. Do not crush or chew because the||
1768|029|H|drug has a bitter taste.||
1768|030|H|   If you are using the liquid form of this medication, measure||
1768|031|H|the dose carefully using a special measuring device/cup. Do not||
1768|032|H|use a household spoon because you may not get the correct dose.||
1768|033|H|   Use this medication regularly to get the most benefit from it.||
1768|034|H|To help you remember, take it at the same times each day.||
1768|035|H|   Do not stop taking this medication without consulting your||
1768|036|H|doctor. Your seizures may become worse when this drug is suddenly||
1768|037|H|stopped. Your dose may need to be gradually decreased.||
1768|038|H|   Tell your doctor if your seizures do not get better or if they||
1768|039|H|get worse.||
1768|040|B|||
1768|041|S|SIDE EFFECTS:  Drowsiness, dizziness, tiredness, or||
1768|042|S|nausea/vomiting may occur. If any of these effects last or get||
1768|043|S|worse, tell your doctor or pharmacist promptly.||
1768|044|S|   Remember that this medication has been prescribed because your||
1768|045|S|doctor has judged that the benefit to you is greater than the||
1768|046|S|risk of side effects. Many people using this medication do not||
1768|047|S|have serious side effects.||
1768|048|S|   A small number of people who take anticonvulsants for any||
1768|049|S|condition (such as seizure, bipolar disorder, pain) may||
1768|050|S|experience depression, suicidal thoughts/attempts, or other||
1768|051|S|mental/mood problems. Tell your doctor right away if you or your||
1768|052|S|family/caregiver notice any unusual/sudden changes in your mood,||
1768|053|S|thoughts, or behavior such as signs of depression, suicidal||
1768|054|S|thoughts/attempts, thoughts about harming yourself.||
1768|055|S|   Tell your doctor right away if you have any serious side||
1768|056|S|effects, including: loss of coordination, rapid/uncontrollable||
1768|057|S|eye movements.||
1768|058|S|   A very serious allergic reaction to this drug is rare.||
1768|059|S|However, get medical help right away if you notice any symptoms||
1768|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1768|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1768|062|S|breathing.||
1768|063|S|   This is not a complete list of possible side effects. If you||
1768|064|S|notice other effects not listed above, contact your doctor or||
1768|065|S|pharmacist.||
1768|066|S|   In the US -||
1768|067|S|   Call your doctor for medical advice about side effects. You||
1768|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1768|069|S|www.fda.gov/medwatch.||
1768|070|S|   In Canada - Call your doctor for medical advice about side||
1768|071|S|effects. You may report side effects to Health Canada at||
1768|072|S|1-866-234-2345.||
1768|073|B|||
1768|074|P|PRECAUTIONS:  Before taking brivaracetam, tell your doctor or||
1768|075|P|pharmacist if you are allergic to it; or if you have any other||
1768|076|P|allergies. This product may contain inactive ingredients, which||
1768|077|P|can cause allergic reactions or other problems. Talk to your||
1768|078|P|pharmacist for more details.||
1768|079|P|   Before using this medication, tell your doctor or pharmacist||
1768|080|P|your medical history, especially of: liver disease, mental/mood||
1768|081|P|disorders (such as depression).||
1768|082|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1768|083|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1768|084|P|machinery, or do anything that needs alertness until you can do||
1768|085|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1768|086|P|are using marijuana (cannabis).||
1768|087|P|   Before having surgery, tell your doctor or dentist about all||
1768|088|P|the products you use (including prescription drugs,||
1768|089|P|nonprescription drugs, and herbal products).||
1768|090|P|   During pregnancy, this medication should be used only when||
1768|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
1768|092|P|   This medication passes into breast milk. Consult your doctor||
1768|093|P|before breastfeeding.||
1768|094|B|||
1768|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1768|096|I|medications work or increase your risk for serious side effects.||
1768|097|I|This document does not contain all possible drug interactions.||
1768|098|I|Keep a list of all the products you use (including||
1768|099|I|prescription/nonprescription drugs and herbal products) and share||
1768|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
1768|101|I|the dosage of any medicines without your doctor's approval.||
1768|102|I|   A product that may interact with this drug is: orlistat.||
1768|103|B|||
1768|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1768|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1768|106|O|poison control center right away. US residents can call||
1768|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1768|108|O|Symptoms of overdose may include: slow heartbeat, loss of||
1768|109|O|coordination.||
1768|110|B|||
1768|111|N|NOTES:  Do not share this medication with others. Sharing it is||
1768|112|N|against the law.||
1768|113|N|   Lab and/or medical tests (such as complete blood count) may be||
1768|114|N|done while you are taking this medication. Keep all medical and||
1768|115|N|lab appointments. Consult your doctor for more details.||
1768|116|B|||
1768|117|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1768|118|D|remember. If it is near the time of the next dose, skip the||
1768|119|D|missed dose. Take your next dose at the regular time. Do not||
1768|120|D|double the dose to catch up.||
1768|121|B|||
1768|122|R|STORAGE:  Store at room temperature away from light and moisture.||
1768|123|R|Do not store in the bathroom. For the liquid form, once the||
1768|124|R|bottle is opened, the medication expires after 5 months. Keep all||
1768|125|R|medications away from children and pets.||
1768|126|R|   Do not flush medications down the toilet or pour them into a||
1768|127|R|drain unless instructed to do so. Properly discard this product||
1768|128|R|when it is expired or no longer needed. Consult your pharmacist||
1768|129|R|or local waste disposal company.||
1768|130|B|||
1768|131|M|MEDICAL ALERT:  Your condition can cause complications in a||
1768|132|M|medical emergency. For information about enrolling in MedicAlert,||
1768|133|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1768|134|B|||
1768|135|A|Information last revised September 2024.||
1768|136|A|Copyright(c) 2025 First Databank, Inc.||
1768|137|B|||
1770|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1770|002|Z|does NOT have all possible information about this product. This||
1770|003|Z|information does not assure that this product is safe, effective,||
1770|004|Z|or appropriate for you. This information is not individual||
1770|005|Z|medical advice and does not substitute for the advice of your||
1770|006|Z|health care professional. Always ask your health care||
1770|007|Z|professional for complete information about this product and your||
1770|008|Z|specific health needs.||
1770|009|B|||
1770|010|T|ATEZOLIZUMAB - INJECTION||
1770|011|F|(A-te-zoe-LIZ-ue-mab)||
1770|012|B|||
1770|013|C|COMMON BRAND NAME(S): Tecentriq||
1770|014|B|||
1770|015|U|USES:  This medication is used to treat various cancers (such as||
1770|016|U|liver/lung/skin cancer, alveolar soft part sarcoma - ASPS). It||
1770|017|U|works by helping your immune system fight the cancer.||
1770|018|U|Atezolizumab belongs to a class of drugs known as monoclonal||
1770|019|U|antibodies.||
1770|020|B|||
1770|021|H|HOW TO USE:  Read the Medication Guide provided by your||
1770|022|H|pharmacist before you start receiving atezolizumab and each time||
1770|023|H|you get a treatment. If you have any questions, ask your doctor||
1770|024|H|or pharmacist.||
1770|025|H|   This medication is given by a health care professional. It is||
1770|026|H|injected slowly into a vein over 30 to 60 minutes as directed by||
1770|027|H|your doctor. The dosage and treatment schedule are based on your||
1770|028|H|medical condition and response to treatment. Children's dosage is||
1770|029|H|also based on weight.||
1770|030|H|   Infusion reactions may happen during the infusion of this||
1770|031|H|drug. Tell your doctor right away if you have any symptoms of||
1770|032|H|infusion reactions such as chills, itching, shortness of breath,||
1770|033|H|flushing, dizziness, lightheadedness, fever, back/neck pain. Your||
1770|034|H|doctor may give you other medications to help with these side||
1770|035|H|effects or may slow down or stop your treatment for some time.||
1770|036|H|   Use this medication regularly to get the most benefit from it.||
1770|037|H|To help you remember, mark your calendar with a reminder.||
1770|038|B|||
1770|039|S|SIDE EFFECTS:  See also How to Use section.||
1770|040|S|   Tiredness, loss of appetite, muscle/bone pain, or nausea may||
1770|041|S|occur. If any of these effects last or get worse, tell your||
1770|042|S|doctor or pharmacist promptly.||
1770|043|S|   Remember that this medication has been prescribed because your||
1770|044|S|doctor has judged that the benefit to you is greater than the||
1770|045|S|risk of side effects. Many people using this medication do not||
1770|046|S|have serious side effects.||
1770|047|S|   Tell your doctor right away if you have any serious side||
1770|048|S|effects, including: new/worsening cough, diarrhea, black/tarry||
1770|049|S|stool, signs of liver disease (nausea/vomiting that doesn't stop,||
1770|050|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
1770|051|S|of kidney problems (such as pink/bloody urine, change in the||
1770|052|S|amount of urine), eye/vision problems (such as blurred vision,||
1770|053|S|vision changes, eye pain), headache that is severe or doesn't go||
1770|054|S|away, stiff/painful neck, numbness/tingling of arms/legs.||
1770|055|S|   This medication may cause hormone gland problems (such as||
1770|056|S|thyroid, pituitary, adrenal, pancreas). Your body could make too||
1770|057|S|much or too little hormone. Tell your doctor right away if you||
1770|058|S|have any symptoms such as: cold or heat intolerance, unexplained||
1770|059|S|weight loss/gain, increased thirst/urination, mood or behavior||
1770|060|S|changes (such as decreased sex drive, irritability,||
1770|061|S|forgetfulness), slow/fast/pounding/irregular heartbeat, unusual||
1770|062|S|tiredness, constipation.||
1770|063|S|   Get medical help right away if you have any very serious side||
1770|064|S|effects, including: chest pain, shortness of breath.||
1770|065|S|   A very serious allergic reaction to this drug is rare.||
1770|066|S|However, get medical help right away if you notice any symptoms||
1770|067|S|of a serious allergic reaction, such as: fever, swollen lymph||
1770|068|S|nodes, rash, itching/swelling (especially of the||
1770|069|S|face/tongue/throat), severe dizziness, trouble breathing.||
1770|070|S|   This is not a complete list of possible side effects. If you||
1770|071|S|notice other effects not listed above, contact your doctor or||
1770|072|S|pharmacist.||
1770|073|S|   In the US -||
1770|074|S|   Call your doctor for medical advice about side effects. You||
1770|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1770|076|S|www.fda.gov/medwatch.||
1770|077|S|   In Canada - Call your doctor for medical advice about side||
1770|078|S|effects. You may report side effects to Health Canada at||
1770|079|S|1-866-234-2345.||
1770|080|B|||
1770|081|P|PRECAUTIONS:  Before using atezolizumab, tell your doctor or||
1770|082|P|pharmacist if you are allergic to it; or if you have any other||
1770|083|P|allergies. This product may contain inactive ingredients, which||
1770|084|P|can cause allergic reactions or other problems. Talk to your||
1770|085|P|pharmacist for more details.||
1770|086|P|   Before using this medication, tell your doctor or pharmacist||
1770|087|P|your medical history, especially of: immune system problems (such||
1770|088|P|as Crohn's disease, ulcerative colitis, lupus), organ transplant,||
1770|089|P|stem cell transplant with donor cells, radiation treatment,||
1770|090|P|nervous system disorders (such as myasthenia gravis,||
1770|091|P|Guillain-Barre syndrome), diabetes.||
1770|092|P|   Before having surgery, tell your doctor or dentist about all||
1770|093|P|the products you use (including prescription drugs,||
1770|094|P|nonprescription drugs, and herbal products).||
1770|095|P|   Tell your doctor if you are pregnant or plan to become||
1770|096|P|pregnant. You should not become pregnant while using||
1770|097|P|atezolizumab. Atezolizumab may harm an unborn baby. Ask about||
1770|098|P|reliable forms of birth control while using this medication and||
1770|099|P|for at least 5 months after the last dose. If you become||
1770|100|P|pregnant, talk to your doctor right away about the risks and||
1770|101|P|benefits of this medication.||
1770|102|P|   It is unknown if this drug passes into breast milk. Because of||
1770|103|P|the possible risk to the infant, breastfeeding is not recommended||
1770|104|P|while using this drug and for at least 5 months after the last||
1770|105|P|dose. Consult your doctor before breastfeeding.||
1770|106|B|||
1770|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1770|108|I|medications work or increase your risk for serious side effects.||
1770|109|I|This document does not contain all possible drug interactions.||
1770|110|I|Keep a list of all the products you use (including||
1770|111|I|prescription/nonprescription drugs and herbal products) and share||
1770|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
1770|113|I|the dosage of any medicines without your doctor's approval.||
1770|114|B|||
1770|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1770|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1770|117|O|poison control center right away. US residents can call||
1770|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1770|119|B|||
1770|120|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
1770|121|N|function) should be done before you start using this medication||
1770|122|N|and while you are using it. Keep all medical and lab||
1770|123|N|appointments.||
1770|124|B|||
1770|125|D|MISSED DOSE:  It is important to get each dose of this medication||
1770|126|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1770|127|D|right away for a new dosing schedule.||
1770|128|B|||
1770|129|R|STORAGE:  Not applicable. This medication is given in a hospital||
1770|130|R|or clinic and will not be stored at home.||
1770|131|B|||
1770|132|A|Information last revised August 2025.||
1770|133|A|Copyright(c) 2025 First Databank, Inc.||
1770|134|B|||
1772|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1772|002|Z|does NOT have all possible information about this product. This||
1772|003|Z|information does not assure that this product is safe, effective,||
1772|004|Z|or appropriate for you. This information is not individual||
1772|005|Z|medical advice and does not substitute for the advice of your||
1772|006|Z|health care professional. Always ask your health care||
1772|007|Z|professional for complete information about this product and your||
1772|008|Z|specific health needs.||
1772|009|B|||
1772|010|T|MESALAMINE (5-AMINOSALICYLIC ACID) DELAYED-REL TABS IN CAP-ORAL||
1772|011|F|(me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id)||
1772|012|B|||
1772|013|C|COMMON BRAND NAME(S): Delzicol||
1772|014|B|||
1772|015|U|USES:  This medication is used to treat a certain bowel disease||
1772|016|U|(ulcerative colitis). It helps to reduce symptoms of ulcerative||
1772|017|U|colitis such as diarrhea, rectal bleeding, and stomach pain.||
1772|018|U|Mesalamine belongs to a class of drugs known as aminosalicylates.||
1772|019|U|It works by decreasing swelling in the colon.||
1772|020|B|||
1772|021|H|HOW TO USE:  Take this medication by mouth with or without food||
1772|022|H|as directed by your doctor, usually 3 times daily.||
1772|023|H|   Swallow the capsule whole. Do not crush, chew, or break. Doing||
1772|024|H|so can keep the drug from being released properly into the colon.||
1772|025|H|If you have trouble swallowing the capsule, you may open the||
1772|026|H|capsule and swallow the tablets found in the capsule. Do not cut,||
1772|027|H|crush, chew, or break the tablets before swallowing. Be sure to||
1772|028|H|swallow all of the tablets.||
1772|029|H|   Drink plenty of fluids during treatment with this medication||
1772|030|H|unless otherwise directed by your doctor. This will help prevent||
1772|031|H|kidney stones.||
1772|032|H|   The dosage is based on your medical condition and response to||
1772|033|H|treatment. Children's dosage is also based on weight. Different||
1772|034|H|brands of this medication provide different amounts of||
1772|035|H|medication. If you need to switch brands, ask your doctor how to||
1772|036|H|do so safely.||
1772|037|H|   Use this medication regularly to get the most benefit from it.||
1772|038|H|To help you remember, take it at the same times each day.||
1772|039|H|   Tell your doctor if your condition lasts or gets worse.||
1772|040|B|||
1772|041|S|SIDE EFFECTS:  Stomach upset, nausea/vomiting, constipation,||
1772|042|S|headache, or joint/muscle pain may occur. If any of these effects||
1772|043|S|last or get worse, tell your doctor or pharmacist promptly.||
1772|044|S|   You may sometimes see whole or partial tablets in your stool.||
1772|045|S|If this happens often, tell your doctor. You may not be absorbing||
1772|046|S|enough of the medication.||
1772|047|S|   Remember that this medication has been prescribed because your||
1772|048|S|doctor has judged that the benefit to you is greater than the||
1772|049|S|risk of side effects. Many people using this medication do not||
1772|050|S|have serious side effects.||
1772|051|S|   Rarely, mesalamine can worsen ulcerative colitis. Tell your||
1772|052|S|doctor right away if your symptoms worsen after starting this||
1772|053|S|medication (such as increased abdominal pain/cramping, bloody||
1772|054|S|diarrhea).||
1772|055|S|   Tell your doctor right away if you have any serious side||
1772|056|S|effects, including: signs of kidney problems (such as change in||
1772|057|S|the amount of urine, blood in the urine), dark urine,||
1772|058|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain,||
1772|059|S|yellowing eyes/skin, chest pain, shortness of breath.||
1772|060|S|   A very serious allergic reaction to this drug is rare.||
1772|061|S|However, get medical help right away if you notice any symptoms||
1772|062|S|of a serious allergic reaction, including: fever, swollen lymph||
1772|063|S|nodes, rash, itching/swelling (especially of the||
1772|064|S|face/tongue/throat), severe dizziness, trouble breathing.||
1772|065|S|   This is not a complete list of possible side effects. If you||
1772|066|S|notice other effects not listed above, contact your doctor or||
1772|067|S|pharmacist.||
1772|068|S|   In the US -||
1772|069|S|   Call your doctor for medical advice about side effects. You||
1772|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1772|071|S|www.fda.gov/medwatch.||
1772|072|S|   In Canada - Call your doctor for medical advice about side||
1772|073|S|effects. You may report side effects to Health Canada at||
1772|074|S|1-866-234-2345.||
1772|075|B|||
1772|076|P|PRECAUTIONS:  Before taking mesalamine, tell your doctor or||
1772|077|P|pharmacist if you are allergic to it; or to other||
1772|078|P|aminosalicylates (such as balsalazide, olsalazine); or to||
1772|079|P|salicylates (such as aspirin, salsalate); or to sulfasalazine; or||
1772|080|P|if you have any other allergies. This product may contain||
1772|081|P|inactive ingredients, which can cause allergic reactions or other||
1772|082|P|problems. Talk to your pharmacist for more details.||
1772|083|P|   Before using this medication, tell your doctor or pharmacist||
1772|084|P|your medical history, especially of: kidney disease, liver||
1772|085|P|disease, stomach blockage (such as pyloric stenosis).||
1772|086|P|   This medication may make you more sensitive to the sun,||
1772|087|P|especially if you have skin problems (such as atopic dermatitis,||
1772|088|P|eczema). Limit your time in the sun. Avoid tanning booths and||
1772|089|P|sunlamps. Use sunscreen and wear protective clothing when||
1772|090|P|outdoors. Tell your doctor right away if you get sunburned or||
1772|091|P|have skin blisters/redness.||
1772|092|P|   Before having surgery, tell your doctor or dentist about all||
1772|093|P|the products you use (including prescription drugs,||
1772|094|P|nonprescription drugs, and herbal products).||
1772|095|P|   This medication is similar to aspirin. Children and teenagers||
1772|096|P|younger than 18 years should not take aspirin or aspirin-related||
1772|097|P|medications (such as salicylates) if they have chickenpox, flu,||
1772|098|P|or any undiagnosed illness, or if they have recently received a||
1772|099|P|vaccine. In these cases, taking mesalamine increases the risk of||
1772|100|P|Reye's syndrome, a rare but serious illness.||
1772|101|P|   During pregnancy, this medication should be used only when||
1772|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
1772|103|P|   This medication passes into breast milk and may have||
1772|104|P|undesirable effects on a nursing infant. Consult your doctor||
1772|105|P|before breastfeeding.||
1772|106|B|||
1772|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1772|108|I|medications work or increase your risk for serious side effects.||
1772|109|I|This document does not contain all possible drug interactions.||
1772|110|I|Keep a list of all the products you use (including||
1772|111|I|prescription/nonprescription drugs and herbal products) and share||
1772|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
1772|113|I|the dosage of any medicines without your doctor's approval.||
1772|114|I|   Mesalamine is very similar to balsalazide, olsalazine, and||
1772|115|I|sulfasalazine. Do not use medications containing balsalazide,||
1772|116|I|olsalazine, or sulfasalazine while using mesalamine.||
1772|117|I|   This medication may interfere with certain lab tests (such as||
1772|118|I|urine normetanephrine levels), possibly causing false test||
1772|119|I|results. Make sure lab personnel and all your doctors know you||
1772|120|I|use this drug.||
1772|121|B|||
1772|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1772|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1772|124|O|poison control center right away. US residents can call||
1772|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1772|126|O|Symptoms of overdose may include: ringing in the ears, confusion,||
1772|127|O|rapid breathing, seizures.||
1772|128|B|||
1772|129|N|NOTES:  Do not share this medication with others.||
1772|130|N|   Lab and/or medical tests (such as liver/kidney function) may||
1772|131|N|be done before you start taking this medication and while you are||
1772|132|N|taking it. Keep all medical and lab appointments. Consult your||
1772|133|N|doctor for more details.||
1772|134|B|||
1772|135|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1772|136|D|remember. If it is near the time of the next dose, skip the||
1772|137|D|missed dose. Take your next dose at the regular time. Do not||
1772|138|D|double the dose to catch up.||
1772|139|B|||
1772|140|R|STORAGE:  Store at room temperature away from light and moisture.||
1772|141|R|Do not store in the bathroom. If your medication bottle comes||
1772|142|R|with a drying agent (desiccant), keep the desiccant in the||
1772|143|R|bottle. Tightly close the bottle when not in use. Keep all||
1772|144|R|medications away from children and pets.||
1772|145|R|   Do not flush medications down the toilet or pour them into a||
1772|146|R|drain unless instructed to do so. Properly discard this product||
1772|147|R|when it is expired or no longer needed. Consult your pharmacist||
1772|148|R|or local waste disposal company.||
1772|149|B|||
1772|150|A|Information last revised September 2024.||
1772|151|A|Copyright(c) 2025 First Databank, Inc.||
1772|152|B|||
1773|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1773|002|Z|does NOT have all possible information about this product. This||
1773|003|Z|information does not assure that this product is safe, effective,||
1773|004|Z|or appropriate for you. This information is not individual||
1773|005|Z|medical advice and does not substitute for the advice of your||
1773|006|Z|health care professional. Always ask your health care||
1773|007|Z|professional for complete information about this product and your||
1773|008|Z|specific health needs.||
1773|009|B|||
1773|010|T|LINAGLIPTIN/METFORMIN EXTENDED-RELEASE - ORAL||
1773|011|F|(LIN-a-GLIP-tin/met-FOR-min)||
1773|012|B|||
1773|013|C|COMMON BRAND NAME(S): Jentadueto XR||
1773|014|B|||
1773|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1773|016|W|cause a serious (sometimes fatal) condition called lactic||
1773|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1773|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1773|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1773|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1773|021|W|you are using certain drugs. For some conditions, your doctor may||
1773|022|W|tell you to stop taking this medication for a short time. Ask||
1773|023|W|your doctor or pharmacist for more details.||
1773|024|W|   Stop taking this medication and get medical help right away if||
1773|025|W|you have any symptoms of lactic acidosis, such as unusual||
1773|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1773|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1773|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1773|029|B|||
1773|030|U|USES:  Linagliptin/metformin is used with a proper diet and||
1773|031|U|exercise program to control high blood sugar in people with type||
1773|032|U|2 diabetes. Controlling high blood sugar helps prevent kidney||
1773|033|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1773|034|U|function problems. Proper control of diabetes may also lessen||
1773|035|U|your risk of a heart attack or stroke.||
1773|036|U|   This product contains 2 medications: linagliptin and||
1773|037|U|metformin. Linagliptin works by increasing levels of natural||
1773|038|U|substances called incretins. Incretins help to control blood||
1773|039|U|sugar by increasing insulin release, especially after a meal.||
1773|040|U|They also decrease the amount of sugar your liver makes.||
1773|041|U|Metformin works by helping to restore your body's proper response||
1773|042|U|to the insulin you naturally produce. It also decreases the||
1773|043|U|amount of sugar that your liver makes and that your||
1773|044|U|stomach/intestines absorb.||
1773|045|B|||
1773|046|H|HOW TO USE:  Read the Medication Guide provided by your||
1773|047|H|pharmacist before you start taking linagliptin/metformin and each||
1773|048|H|time you get a refill. If you have any questions, ask your doctor||
1773|049|H|or pharmacist.||
1773|050|H|   Take this medication by mouth as directed by your doctor,||
1773|051|H|usually once daily with a meal. Swallow the tablets whole. Do not||
1773|052|H|crush, chew, or dissolve the tablets. Doing so can release all of||
1773|053|H|the drug at once, increasing the risk of side effects. Drink||
1773|054|H|plenty of fluids while taking this medication unless otherwise||
1773|055|H|directed by your doctor.||
1773|056|H|   The dosage is based on your medical condition, response to||
1773|057|H|treatment, and other medications you may be taking. Be sure to||
1773|058|H|tell your doctor and pharmacist about all the products you use||
1773|059|H|(including prescription drugs, nonprescription drugs, and herbal||
1773|060|H|products).||
1773|061|H|   Take this medication regularly to get the most benefit from||
1773|062|H|it. To help you remember, take it at the same time each day.||
1773|063|H|   Tell your doctor if your condition does not get better or if||
1773|064|H|it gets worse (your blood sugar levels are too high or too low).||
1773|065|B|||
1773|066|S|SIDE EFFECTS:  See also Warning section.||
1773|067|S|   Nausea, vomiting, stomach upset, runny/stuffy nose, or||
1773|068|S|diarrhea may occur. If any of these effects last or get worse,||
1773|069|S|tell your doctor or pharmacist promptly. If stomach symptoms||
1773|070|S|return later (after taking the same dose for several days or||
1773|071|S|weeks), tell your doctor right away. Stomach symptoms that occur||
1773|072|S|after the first days of your treatment may be signs of lactic||
1773|073|S|acidosis.||
1773|074|S|   An empty tablet shell may appear in your stool. This effect is||
1773|075|S|harmless because your body has already absorbed the medication.||
1773|076|S|   Remember that this medication has been prescribed because your||
1773|077|S|doctor has judged that the benefit to you is greater than the||
1773|078|S|risk of side effects. Many people using this medication do not||
1773|079|S|have serious side effects.||
1773|080|S|   Tell your doctor right away if you have any serious side||
1773|081|S|effects, including: joint pain, unusual skin blisters, signs of||
1773|082|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1773|083|S|unusual tiredness, unusual/sudden weight gain).||
1773|084|S|   Get medical help right away if you have any very serious side||
1773|085|S|effects, including: signs of disease of the pancreas (such as||
1773|086|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain||
1773|087|S|which may spread to the back).||
1773|088|S|   This medication does not usually cause low blood sugar||
1773|089|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1773|090|S|prescribed with other diabetes medications, or if you do not get||
1773|091|S|enough calories from food, or if you do unusually heavy exercise.||
1773|092|S|Talk with your doctor or pharmacist about whether the dose of||
1773|093|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1773|094|S|of low blood sugar include sudden sweating, shaking, fast||
1773|095|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1773|096|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1773|097|S|treat low blood sugar. If you don't have these reliable forms of||
1773|098|S|glucose, rapidly raise your blood sugar by eating a quick source||
1773|099|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1773|100|S|juice or non-diet soda. Tell your doctor right away about the||
1773|101|S|reaction and the use of this product. To help prevent low blood||
1773|102|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1773|103|S|Check with your doctor or pharmacist to find out what you should||
1773|104|S|do if you miss a meal.||
1773|105|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1773|106|S|thirst/urination. If these symptoms occur, tell your doctor right||
1773|107|S|away. Your doctor may need to adjust your diabetes medication,||
1773|108|S|exercise program, or diet.||
1773|109|S|   A very serious allergic reaction to this drug is rare.||
1773|110|S|However, get medical help right away if you notice any symptoms||
1773|111|S|of a serious allergic reaction, including: rash, itching/swelling||
1773|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1773|113|S|breathing.||
1773|114|S|   This is not a complete list of possible side effects. If you||
1773|115|S|notice other effects not listed above, contact your doctor or||
1773|116|S|pharmacist.||
1773|117|S|   In the US -||
1773|118|S|   Call your doctor for medical advice about side effects. You||
1773|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1773|120|S|www.fda.gov/medwatch.||
1773|121|S|   In Canada - Call your doctor for medical advice about side||
1773|122|S|effects. You may report side effects to Health Canada at||
1773|123|S|1-866-234-2345.||
1773|124|B|||
1773|125|P|PRECAUTIONS:  See also Warning section.||
1773|126|P|   Before taking this medication, tell your doctor or pharmacist||
1773|127|P|if you are allergic to linagliptin or metformin; or if you have||
1773|128|P|any other allergies. This product may contain inactive||
1773|129|P|ingredients, which can cause allergic reactions or other||
1773|130|P|problems. Talk to your pharmacist for more details.||
1773|131|P|   Before using this medication, tell your doctor or pharmacist||
1773|132|P|your medical history, especially of: kidney disease, breathing||
1773|133|P|problems (such as obstructive lung disease, asthma), liver||
1773|134|P|disease, blood problems (such as anemia, vitamin B12 deficiency),||
1773|135|P|a disease of the pancreas (pancreatitis), stones in your||
1773|136|P|gallbladder (gallstones).||
1773|137|P|   Before having surgery or any X-ray/scanning procedure using||
1773|138|P|iodinated contrast, tell your doctor or dentist about all the||
1773|139|P|products you use (including prescription drugs, nonprescription||
1773|140|P|drugs, and herbal products). You may need to stop this medication||
1773|141|P|for a short time for the surgery/procedure. Ask your doctor or||
1773|142|P|dentist for instructions before your surgery/procedure.||
1773|143|P|   You may experience blurred vision, dizziness, or drowsiness||
1773|144|P|due to extremely low or high blood sugar. Do not drive, use||
1773|145|P|machinery, or do anything that needs alertness or clear vision||
1773|146|P|until you can do it safely.||
1773|147|P|   Limit alcohol while taking this medication because it can||
1773|148|P|increase your risk of developing lactic acidosis, pancreatitis,||
1773|149|P|and low blood sugar.||
1773|150|P|   High fever, "water pills" (diuretics such as||
1773|151|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1773|152|P|may cause dehydration and increase your risk of lactic acidosis.||
1773|153|P|Stop taking this medication and tell your doctor right away if||
1773|154|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1773|155|P|fluids to prevent dehydration unless your doctor directs you||
1773|156|P|otherwise.||
1773|157|P|   It may be harder to control your blood sugar when your body is||
1773|158|P|stressed (such as due to fever, infection, injury, or surgery).||
1773|159|P|Consult your doctor because this may require a change in your||
1773|160|P|treatment plan, medications, or blood sugar testing.||
1773|161|P|   Older adults may be more sensitive to the side effects of this||
1773|162|P|drug, especially low blood sugar or lactic acidosis.||
1773|163|P|   Metformin can cause changes in the menstrual cycle (promote||
1773|164|P|ovulation) and increase the risk of becoming pregnant. Consult||
1773|165|P|your doctor or pharmacist about the use of reliable birth control||
1773|166|P|while using this medication.||
1773|167|P|   During pregnancy, this medication should be used only when||
1773|168|P|clearly needed. Discuss the risks and benefits with your doctor.||
1773|169|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1773|170|P|your doctor for managing your blood sugar while pregnant. Your||
1773|171|P|doctor may change your diabetes treatment during your pregnancy||
1773|172|P|(such as diet and medications including insulin).||
1773|173|P|   Metformin passes into breast milk. It is unknown if||
1773|174|P|linagliptin passes into breast milk. Consult your doctor before||
1773|175|P|breastfeeding.||
1773|176|B|||
1773|177|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1773|178|I|medications work or increase your risk for serious side effects.||
1773|179|I|This document does not contain all possible drug interactions.||
1773|180|I|Keep a list of all the products you use (including||
1773|181|I|prescription/nonprescription drugs and herbal products) and share||
1773|182|I|it with your doctor and pharmacist. Do not start, stop, or change||
1773|183|I|the dosage of any medicines without your doctor's approval.||
1773|184|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1773|185|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1773|186|I|heartbeat you would usually feel when your blood sugar level||
1773|187|I|falls too low (hypoglycemia). Other symptoms of low blood sugar,||
1773|188|I|such as dizziness, hunger, or sweating, are not affected by these||
1773|189|I|drugs.||
1773|190|I|   Many drugs can affect your blood sugar levels, making it more||
1773|191|I|difficult to control your blood sugar. Before you start, stop, or||
1773|192|I|change any medication, talk with your doctor or pharmacist about||
1773|193|I|how the medication may affect your blood sugar. Check your blood||
1773|194|I|sugar levels regularly as directed by your doctor. Tell your||
1773|195|I|doctor about the results and of any symptoms of high or low blood||
1773|196|I|sugar. (See also Side Effects section.) Your doctor may need to||
1773|197|I|adjust your anti-diabetic medication, exercise program, or diet.||
1773|198|I|   Other medications can affect the removal of linagliptin from||
1773|199|I|your body, which may affect how linagliptin works. One example is||
1773|200|I|rifampin, among others.||
1773|201|B|||
1773|202|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1773|203|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1773|204|O|poison control center right away. US residents can call||
1773|205|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1773|206|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
1773|207|O|include: severe drowsiness, rapid breathing, slow/irregular||
1773|208|O|heartbeat.||
1773|209|B|||
1773|210|N|NOTES:  Do not share this medication with others.||
1773|211|N|   Attend a diabetes education program to learn more about how to||
1773|212|N|manage your diabetes with medications, diet, exercise, and||
1773|213|N|regular medical exams.||
1773|214|N|   Learn the symptoms of high and low blood sugar and how to||
1773|215|N|treat low blood sugar. Check your blood sugar levels regularly as||
1773|216|N|directed.||
1773|217|N|   Lab and/or medical tests (such as kidney function, liver||
1773|218|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
1773|219|N|should be done before you start taking this medication and while||
1773|220|N|you are taking it. Keep all medical and lab appointments. Consult||
1773|221|N|your doctor for more details.||
1773|222|B|||
1773|223|D|MISSED DOSE:  If you miss a dose, take it with food as soon as||
1773|224|D|you remember. If it is near the time of the next dose, skip the||
1773|225|D|missed dose. Take your next dose at the regular time. Do not||
1773|226|D|double the dose to catch up.||
1773|227|B|||
1773|228|R|STORAGE:  Store at room temperature away from light and moisture.||
1773|229|R|Do not store in the bathroom. Keep all medications away from||
1773|230|R|children and pets.||
1773|231|R|   Do not flush medications down the toilet or pour them into a||
1773|232|R|drain unless instructed to do so. Properly discard this product||
1773|233|R|when it is expired or no longer needed. Consult your pharmacist||
1773|234|R|or local waste disposal company.||
1773|235|B|||
1773|236|M|MEDICAL ALERT:  Your condition can cause complications in a||
1773|237|M|medical emergency. For information about enrolling in MedicAlert,||
1773|238|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1773|239|B|||
1773|240|A|Information last revised May 2025.||
1773|241|A|Copyright(c) 2025 First Databank, Inc.||
1773|242|B|||
1774|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1774|002|Z|does NOT have all possible information about this product. This||
1774|003|Z|information does not assure that this product is safe, effective,||
1774|004|Z|or appropriate for you. This information is not individual||
1774|005|Z|medical advice and does not substitute for the advice of your||
1774|006|Z|health care professional. Always ask your health care||
1774|007|Z|professional for complete information about this product and your||
1774|008|Z|specific health needs.||
1774|009|B|||
1774|010|T|CHOLERA SINGLE DOSE VACCINE - ORAL||
1774|011|F|(KOL-er-a)||
1774|012|B|||
1774|013|C|COMMON BRAND NAME(S): Vaxchora||
1774|014|B|||
1774|015|U|USES:  This vaccine is used to help prevent cholera infection.||
1774|016|U|People can get cholera by eating food or drinking water that has||
1774|017|U|been contaminated. This vaccine is recommended for people who are||
1774|018|U|traveling to areas where this infection is common. This vaccine||
1774|019|U|contains live bacteria that have been weakened. It works by||
1774|020|U|increasing the body's natural defense (immunity) against the||
1774|021|U|bacteria.||
1774|022|U|   Vaccines may not fully protect everyone who receives them.||
1774|023|U|While traveling, you should still avoid contaminated food or||
1774|024|U|water (such as by drinking only bottled or boiled water, eating||
1774|025|U|only fully cooked food). Ask your health care professional for||
1774|026|U|more details.||
1774|027|B|||
1774|028|H|HOW TO USE:  Read all vaccine information available from your||
1774|029|H|health care professional before taking the vaccine. If you have||
1774|030|H|any questions, ask your health care professional.||
1774|031|H|   Take this vaccine by mouth as directed by the health care||
1774|032|H|professional. Do not eat or drink 1 hour before and 1 hour after||
1774|033|H|taking this vaccine.||
1774|034|H|    You should get this vaccine at least 10 days before traveling||
1774|035|H|to at-risk areas.||
1774|036|B|||
1774|037|S|SIDE EFFECTS:  Diarrhea, tiredness, headache, abdominal pain,||
1774|038|S|nausea, vomiting, or loss of appetite may occur. If any of these||
1774|039|S|effects last or get worse, tell your health care professional||
1774|040|S|promptly.||
1774|041|S|   Remember that this vaccine has been prescribed because your||
1774|042|S|health care professional has judged that the benefit to you is||
1774|043|S|greater than the risk of side effects. Many people using this||
1774|044|S|vaccine do not have serious side effects.||
1774|045|S|   A very serious allergic reaction to this vaccine is rare.||
1774|046|S|However, get medical help right away if you notice any symptoms||
1774|047|S|of a serious allergic reaction, including: rash, itching/swelling||
1774|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1774|049|S|breathing.||
1774|050|S|   This is not a complete list of possible side effects. If you||
1774|051|S|notice other effects not listed above, contact your health care||
1774|052|S|professional.||
1774|053|S|   Contact the health care professional for medical advice about||
1774|054|S|side effects. The following numbers do not provide medical||
1774|055|S|advice, but in the US you may report side effects to the Vaccine||
1774|056|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
1774|057|S|Canada, you may call the Vaccine Safety Section at Public Health||
1774|058|S|Agency of Canada at 1-866-844-0018.||
1774|059|B|||
1774|060|P|PRECAUTIONS:  Before you take this vaccine, tell the health care||
1774|061|P|professional if you are allergic to it; or if you have any other||
1774|062|P|allergies. This product may contain inactive ingredients, which||
1774|063|P|can cause allergic reactions or other problems. Talk to your||
1774|064|P|health care professional for more details.||
1774|065|P|   Before taking this vaccine, tell your health care professional||
1774|066|P|your medical history, especially of: current fever/illness,||
1774|067|P|immune system disorders (such as due to HIV infection, certain||
1774|068|P|cancers such as leukemia/lymphoma, cancer or radiation||
1774|069|P|treatment), vaccination history (including previous reactions to||
1774|070|P|any vaccines).||
1774|071|P|   A weakened form of the bacteria may pass in your stools for at||
1774|072|P|least 7 days after taking this vaccine. Rarely, an infection may||
1774|073|P|occur in people who are in close contact with you. To prevent the||
1774|074|P|spread of infection, always wash your hands well after using the||
1774|075|P|bathroom and before preparing/handling any food. Discuss the||
1774|076|P|risks and benefits of this vaccine with your health care||
1774|077|P|professional if you have family/household members with weakened||
1774|078|P|immune systems (such as due to cancer).||
1774|079|P|   During pregnancy, this vaccine should be taken only when||
1774|080|P|clearly needed. Discuss the risks and benefits with your health||
1774|081|P|care professional.||
1774|082|P|   It is unknown if this vaccine passes into breast milk. Consult||
1774|083|P|your health care professional before breastfeeding.||
1774|084|B|||
1774|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1774|086|I|medications work or increase your risk for serious side effects.||
1774|087|I|This document does not contain all possible drug interactions.||
1774|088|I|Keep a list of all the products you use (including||
1774|089|I|prescription/nonprescription drugs and herbal products) and share||
1774|090|I|it with your health care professional. Do not start, stop, or||
1774|091|I|change the dosage of any medicines without your doctor's||
1774|092|I|approval.||
1774|093|I|   Some products that may interact with this vaccine are: drugs||
1774|094|I|that weaken the immune system (including cyclosporine,||
1774|095|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1774|096|I|prednisone).||
1774|097|I|   Avoid using antibiotics when receiving this vaccine. If you||
1774|098|I|are currently using an antibiotic, do not take this vaccine until||
1774|099|I|at least 14 days after stopping the antibiotic.||
1774|100|I|   Avoid taking a certain medication (chloroquine) used to||
1774|101|I|prevent malaria when receiving this vaccine. Take this vaccine at||
1774|102|I|least 10 days before you start treatment with chloroquine.||
1774|103|B|||
1774|104|O|OVERDOSE:  Not applicable.||
1774|105|B|||
1774|106|N|NOTES:  Keep all medical and lab appointments.||
1774|107|N|   Keep vaccine records for yourself and your children and||
1774|108|N|provide them to the health care professionals to prevent||
1774|109|N|unnecessary re-vaccinations.||
1774|110|B|||
1774|111|D|MISSED DOSE:  Not applicable.||
1774|112|B|||
1774|113|R|STORAGE:  Store in the refrigerator away from light and moisture.||
1774|114|R|This vaccine may also be stored at room temperature for up to 24||
1774|115|R|hours before mixing. Keep all medications away from children and||
1774|116|R|pets.||
1774|117|R|   Do not flush medications down the toilet or pour them into a||
1774|118|R|drain unless instructed to do so. Properly discard this product||
1774|119|R|when it is expired or no longer needed. Consult your pharmacist||
1774|120|R|or local waste disposal company.||
1774|121|B|||
1774|122|A|Information last revised February 2025.||
1774|123|A|Copyright(c) 2025 First Databank, Inc.||
1774|124|B|||
1775|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1775|002|Z|does NOT have all possible information about this product. This||
1775|003|Z|information does not assure that this product is safe, effective,||
1775|004|Z|or appropriate for you. This information is not individual||
1775|005|Z|medical advice and does not substitute for the advice of your||
1775|006|Z|health care professional. Always ask your health care||
1775|007|Z|professional for complete information about this product and your||
1775|008|Z|specific health needs.||
1775|009|B|||
1775|010|T|GLYCOPYRROLATE/FORMOTEROL HFA INHALER - ORAL INHALATION||
1775|011|F|(GLYE-koe-PIR-oh-late/for-MOE-ter-ol)||
1775|012|B|||
1775|013|C|COMMON BRAND NAME(S): Bevespi Aerosphere||
1775|014|B|||
1775|015|U|USES:  This product is used to control and prevent symptoms (such||
1775|016|U|as wheezing and shortness of breath) caused by ongoing lung||
1775|017|U|disease (chronic obstructive pulmonary disease-COPD, which||
1775|018|U|includes chronic bronchitis and emphysema). Controlling symptoms||
1775|019|U|of breathing problems helps you maintain your normal activities||
1775|020|U|and decreases time lost from work or school. This inhaler||
1775|021|U|contains 2 medications: glycopyrrolate and formoterol. Both drugs||
1775|022|U|work by relaxing the muscles around the airways so that they open||
1775|023|U|up and you can breathe more easily. Glycopyrrolate belongs to a||
1775|024|U|class of drugs known as anticholinergics. Formoterol belongs to||
1775|025|U|the class of drugs known as long-acting beta agonists (LABAs).||
1775|026|U|Both drugs are also known as bronchodilators.||
1775|027|U|   This medication must be used regularly to be effective. It||
1775|028|U|does not work right away and should not be used to relieve sudden||
1775|029|U|breathing problems. If sudden shortness of breath occurs, use||
1775|030|U|your quick-relief inhaler as prescribed.||
1775|031|U|   Glycopyrrolate/formoterol is not approved to treat asthma.||
1775|032|U|People with asthma using long-acting inhaled beta agonists (such||
1775|033|U|as formoterol) without also using an inhaled corticosteroid may||
1775|034|U|have an increased risk of serious (sometimes fatal) breathing||
1775|035|U|problems.||
1775|036|B|||
1775|037|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1775|038|H|your pharmacist before you start using this medication and each||
1775|039|H|time you get a refill. Follow the illustrated directions for the||
1775|040|H|proper use of this medication. If you have any questions, ask||
1775|041|H|your doctor or pharmacist.||
1775|042|H|   Shake the canister well before using. Follow the instructions||
1775|043|H|for test sprays in the air if you are using a canister for the||
1775|044|H|first time or if you have not used it for a week or more. A fine||
1775|045|H|mist is a sign that the inhaler is working properly. When priming||
1775|046|H|the inhaler, make sure to spray away from your face so that you||
1775|047|H|do not get the medication into your eyes.||
1775|048|H|   Inhale this medication by mouth as directed by your doctor,||
1775|049|H|usually twice daily (in the morning and in the evening). Wait at||
1775|050|H|least 1 minute between inhalations.||
1775|051|H|   Use this medication regularly to get the most benefit from it.||
1775|052|H|To help you remember, use it at the same times each day.||
1775|053|H|   Do not increase your dose, use this medication more often, or||
1775|054|H|stop using it without first consulting your doctor. Your||
1775|055|H|condition will not improve any faster, and your risk of side||
1775|056|H|effects will increase.||
1775|057|H|   If you are using other inhalers at the same time, wait at||
1775|058|H|least 1 minute between the use of each medication.||
1775|059|H|   If you have been using a quick-relief inhaler (such as||
1775|060|H|albuterol, also called salbutamol in some countries) on a regular||
1775|061|H|daily schedule (such as 4 times daily), you must stop this||
1775|062|H|schedule and only use the quick-relief inhaler as needed for||
1775|063|H|sudden shortness of breath. Consult your doctor for details.||
1775|064|H|   Learn which of your inhalers you should use every day and||
1775|065|H|which you should use if your breathing suddenly worsens||
1775|066|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1775|067|H|should do if you have new or worsening cough or shortness of||
1775|068|H|breath, wheezing, increased sputum, waking up at night with||
1775|069|H|trouble breathing, if you use your quick-relief inhaler more||
1775|070|H|often, or if your quick-relief inhaler does not seem to be||
1775|071|H|working well. Learn when you can treat sudden breathing problems||
1775|072|H|by yourself and when you must get medical help right away.||
1775|073|H|   Tell your doctor if your condition does not get better or if||
1775|074|H|it gets worse.||
1775|075|B|||
1775|076|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1775|077|S|because your doctor has judged that the benefit to you is greater||
1775|078|S|than the risk of side effects. Many people using this medication||
1775|079|S|do not have serious side effects.||
1775|080|S|   Tell your doctor right away if you have any serious side||
1775|081|S|effects, including: difficult/painful urination, muscle||
1775|082|S|cramps/weakness, increased thirst/urination.||
1775|083|S|   This medication may raise your blood pressure. Check your||
1775|084|S|blood pressure regularly and tell your doctor if the results are||
1775|085|S|high.||
1775|086|S|   Rarely, this medication may cause sudden severe||
1775|087|S|wheezing/trouble breathing right after you use it. If this||
1775|088|S|occurs, use your quick-relief inhaler and get medical help right||
1775|089|S|away.||
1775|090|S|   Get medical help right away if you have any very serious side||
1775|091|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1775|092|S|dizziness, fainting, eye pain/swelling/redness, vision changes||
1775|093|S|(such as seeing rainbows around lights at night, blurred vision).||
1775|094|S|   A very serious allergic reaction to this drug is rare.||
1775|095|S|However, get medical help right away if you notice any symptoms||
1775|096|S|of a serious allergic reaction, including: rash, itching/swelling||
1775|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1775|098|S|breathing.||
1775|099|S|   This is not a complete list of possible side effects. If you||
1775|100|S|notice other effects not listed above, contact your doctor or||
1775|101|S|pharmacist.||
1775|102|S|   In the US -||
1775|103|S|   Call your doctor for medical advice about side effects. You||
1775|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1775|105|S|www.fda.gov/medwatch.||
1775|106|S|   In Canada - Call your doctor for medical advice about side||
1775|107|S|effects. You may report side effects to Health Canada at||
1775|108|S|1-866-234-2345.||
1775|109|B|||
1775|110|P|PRECAUTIONS:  Before using glycopyrrolate/formoterol, tell your||
1775|111|P|doctor or pharmacist if you are allergic to either drug, or if||
1775|112|P|you have any other allergies. This product may contain inactive||
1775|113|P|ingredients, which can cause allergic reactions or other||
1775|114|P|problems. Talk to your pharmacist for more details.||
1775|115|P|   Before using this medication, tell your doctor or pharmacist||
1775|116|P|your medical history, especially of: heart problems (such as||
1775|117|P|chest pain, irregular heartbeat), high blood pressure, seizures,||
1775|118|P|overactive thyroid, diabetes, personal or family history of||
1775|119|P|glaucoma (angle-closure type), difficulty urinating (such as due||
1775|120|P|to an enlarged prostate).||
1775|121|P|   Glycopyrrolate/formoterol may cause a condition that affects||
1775|122|P|the heart rhythm (QT prolongation). QT prolongation can rarely||
1775|123|P|cause serious (rarely fatal) fast/irregular heartbeat and other||
1775|124|P|symptoms (such as severe dizziness, fainting) that need medical||
1775|125|P|attention right away.||
1775|126|P|   The risk of QT prolongation may be increased if you have||
1775|127|P|certain medical conditions or are taking other drugs that may||
1775|128|P|cause QT prolongation. Before using glycopyrrolate/formoterol,||
1775|129|P|tell your doctor or pharmacist of all the drugs you take and if||
1775|130|P|you have any of the following conditions: certain heart problems||
1775|131|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
1775|132|P|family history of certain heart problems (QT prolongation in the||
1775|133|P|EKG, sudden cardiac death).||
1775|134|P|   Low levels of potassium or magnesium in the blood may also||
1775|135|P|increase your risk of QT prolongation. This risk may increase if||
1775|136|P|you use certain drugs (such as diuretics/"water pills") or if you||
1775|137|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1775|138|P|Talk to your doctor about using glycopyrrolate/formoterol safely.||
1775|139|P|   Before having surgery, tell your doctor or dentist about all||
1775|140|P|the products you use (including prescription drugs,||
1775|141|P|nonprescription drugs, and herbal products).||
1775|142|P|   Older adults may be more sensitive to the side effects of this||
1775|143|P|drug, especially QT prolongation (see above).||
1775|144|P|   During pregnancy, this medication should be used only when||
1775|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
1775|146|P|   It is unknown if this medication passes into breast milk.||
1775|147|P|Consult your doctor before breastfeeding.||
1775|148|B|||
1775|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1775|150|I|medications work or increase your risk for serious side effects.||
1775|151|I|This document does not contain all possible drug interactions.||
1775|152|I|Keep a list of all the products you use (including||
1775|153|I|prescription/nonprescription drugs and herbal products) and share||
1775|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
1775|155|I|the dosage of any medicines without your doctor's approval.||
1775|156|I|   Do not use other LABA drugs (such as salmeterol, vilanterol)||
1775|157|I|while using this medication.||
1775|158|B|||
1775|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1775|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1775|161|O|poison control center right away. US residents can call||
1775|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1775|163|O|Symptoms of overdose may include: shaking (tremor), chest pain,||
1775|164|O|fast/irregular heartbeat, severe dizziness.||
1775|165|B|||
1775|166|N|NOTES:  Do not share this medication with others.||
1775|167|N|   Lab and/or medical tests (such as lung function, blood||
1775|168|N|pressure, pulse/heart rate) should be done while you are using||
1775|169|N|this medication. Keep all medical and lab appointments.||
1775|170|N|   Avoid substances that can worsen breathing problems by causing||
1775|171|N|irritation or allergic reaction, such as smoke, pollen, pet||
1775|172|N|dander, dust, and mold.||
1775|173|N|   Because the flu virus can worsen breathing problems, ask your||
1775|174|N|doctor or pharmacist if you should have a flu shot every year.||
1775|175|B|||
1775|176|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1775|177|D|next dose at the regular time. Do not double the dose to catch||
1775|178|D|up.||
1775|179|B|||
1775|180|R|STORAGE:  Store at room temperature away from heat. Do not store||
1775|181|R|near an open flame. Do not open the sealed pouch until you are||
1775|182|R|ready to use the new inhaler. Once the sealed pouch is opened,||
1775|183|R|this medication expires after 3 months. Keep all medications away||
1775|184|R|from children and pets.||
1775|185|R|   Do not flush medications down the toilet or pour them into a||
1775|186|R|drain unless instructed to do so. Properly discard this product||
1775|187|R|when it is expired or no longer needed. Consult your pharmacist||
1775|188|R|or local waste disposal company.||
1775|189|B|||
1775|190|M|MEDICAL ALERT:  Your condition can cause complications in a||
1775|191|M|medical emergency. For information about enrolling in MedicAlert,||
1775|192|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1775|193|B|||
1775|194|A|Information last revised July 2025.||
1775|195|A|Copyright(c) 2025 First Databank, Inc.||
1775|196|B|||
1776|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1776|002|Z|does NOT have all possible information about this product. This||
1776|003|Z|information does not assure that this product is safe, effective,||
1776|004|Z|or appropriate for you. This information is not individual||
1776|005|Z|medical advice and does not substitute for the advice of your||
1776|006|Z|health care professional. Always ask your health care||
1776|007|Z|professional for complete information about this product and your||
1776|008|Z|specific health needs.||
1776|009|B|||
1776|010|T|VON WILLEBRAND FACTOR, RECOMBINANT - INJECTION||
1776|011|B|||
1776|012|C|COMMON BRAND NAME(S): Vonvendi||
1776|013|B|||
1776|014|U|USES:  This product is used to prevent and control bleeding||
1776|015|U|episodes in people with von Willebrand disease. It may also be||
1776|016|U|used to prevent the loss of too much blood during surgery. Von||
1776|017|U|Willebrand factor is a protein normally found in the blood that||
1776|018|U|helps the blood to thicken (clot) and stop bleeding. People with||
1776|019|U|this disease do not have enough of this factor. This product||
1776|020|U|contains a man-made form of von Willebrand factor.||
1776|021|B|||
1776|022|H|HOW TO USE:  This medication is given by injection into a vein as||
1776|023|H|directed by your doctor. After first receiving this medication in||
1776|024|H|a hemophilia treatment center or hospital, some patients may be||
1776|025|H|able to give it to themselves at home. If your doctor directs you||
1776|026|H|to give this medication at home, read the Patient Information||
1776|027|H|Leaflet if available from your pharmacist before you start using||
1776|028|H|this medication and each time you get a refill. Learn all||
1776|029|H|preparation and usage instructions in the product package. Learn||
1776|030|H|how to store and discard medical supplies safely. If you have any||
1776|031|H|questions, ask your health care professional.||
1776|032|H|   Depending on your factor VIII blood level and medical||
1776|033|H|condition, your doctor may direct you to also give factor VIII||
1776|034|H|with your first dose of von Willebrand factor for each bleeding||
1776|035|H|episode. Ask your doctor for more details.||
1776|036|H|   If the medication and the solution used to mix it were||
1776|037|H|refrigerated, bring both to room temperature before mixing. After||
1776|038|H|adding the solution to the powder, gently swirl the mixture to||
1776|039|H|completely dissolve the powder. Do not shake. Before using, check||
1776|040|H|this product for particles or discoloration. If either is||
1776|041|H|present, do not use the liquid.||
1776|042|H|   Check your heartbeat during treatment. If your heart starts to||
1776|043|H|beat faster, give this medication more slowly or briefly stop the||
1776|044|H|infusion until your heart rate returns to normal. Ask your doctor||
1776|045|H|for details on how fast to infuse your dose.||
1776|046|H|   The dosage is based on your medical condition, weight, blood||
1776|047|H|test results, and response to treatment.||
1776|048|H|   Infusion reactions may happen during the infusion of this||
1776|049|H|drug. Tell your doctor right away if you have any symptoms of||
1776|050|H|infusion reactions such as nausea, vomiting, numbness/tingling of||
1776|051|H|the hands/feet, or blurred vision. Your doctor may give you other||
1776|052|H|medications to help with these side effects or may slow down or||
1776|053|H|stop your treatment for some time.||
1776|054|H|   Tell your doctor right away if your bleeding does not stop or||
1776|055|H|if this medication stops working well.||
1776|056|B|||
1776|057|S|SIDE EFFECTS:  See also How to Use section.||
1776|058|S|   Flushing of the face, headache, or fast heartbeat may||
1776|059|S|sometimes occur and can be lessened by giving this medication||
1776|060|S|more slowly. Burning/irritation at the injection site may also||
1776|061|S|occur. If any of these effects last or get worse, tell your||
1776|062|S|doctor or pharmacist promptly.||
1776|063|S|   Remember that this medication has been prescribed because your||
1776|064|S|doctor has judged that the benefit to you is greater than the||
1776|065|S|risk of side effects. Many people using this medication do not||
1776|066|S|have serious side effects.||
1776|067|S|   This medication may rarely cause blood clots (such as heart||
1776|068|S|attack, stroke, blood clots in the lungs or legs). Get medical||
1776|069|S|help right away if you have: shortness of breath/rapid breathing,||
1776|070|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1776|071|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1776|072|S|sudden/severe headaches, trouble speaking, weakness on one side||
1776|073|S|of the body, sudden vision changes.||
1776|074|S|   A very serious allergic reaction to this drug is rare.||
1776|075|S|However, get medical help right away if you notice any symptoms||
1776|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1776|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1776|078|S|breathing.||
1776|079|S|   This is not a complete list of possible side effects. If you||
1776|080|S|notice other effects not listed above, contact your doctor or||
1776|081|S|pharmacist.||
1776|082|S|   In the US -||
1776|083|S|   Call your doctor for medical advice about side effects. You||
1776|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1776|085|S|www.fda.gov/medwatch.||
1776|086|S|   In Canada - Call your doctor for medical advice about side||
1776|087|S|effects. You may report side effects to Health Canada at||
1776|088|S|1-866-234-2345.||
1776|089|B|||
1776|090|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1776|091|P|pharmacist if you are allergic to it; or if you have any other||
1776|092|P|allergies. This product may contain inactive ingredients, which||
1776|093|P|can cause allergic reactions or other problems. Talk to your||
1776|094|P|pharmacist for more details.||
1776|095|P|   Before using this medication, tell your doctor or pharmacist||
1776|096|P|your medical history.||
1776|097|P|   Before having surgery, tell your doctor or dentist about all||
1776|098|P|the products you use (including prescription drugs,||
1776|099|P|nonprescription drugs, and herbal products).||
1776|100|P|   During pregnancy, this medication should be used only when||
1776|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
1776|102|P|   It is unknown if this medication passes into breast milk.||
1776|103|P|Consult your doctor before breastfeeding.||
1776|104|B|||
1776|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1776|106|I|medications work or increase your risk for serious side effects.||
1776|107|I|This document does not contain all possible drug interactions.||
1776|108|I|Keep a list of all the products you use (including||
1776|109|I|prescription/nonprescription drugs and herbal products) and share||
1776|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
1776|111|I|the dosage of any medicines without your doctor's approval.||
1776|112|B|||
1776|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1776|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1776|115|O|poison control center right away. US residents can call||
1776|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1776|117|B|||
1776|118|N|NOTES:  Do not share this medication with others.||
1776|119|N|   Lab and/or medical tests (such as blood levels of von||
1776|120|N|Willebrand factor and factor VIII) should be done while you are||
1776|121|N|using this medication. Keep all medical and lab appointments.||
1776|122|B|||
1776|123|D|MISSED DOSE:  If more than one dose is needed, it is important to||
1776|124|D|follow the dosing schedule as directed by your doctor. If you||
1776|125|D|miss a dose, ask your doctor or pharmacist right away for a new||
1776|126|D|dosing schedule. Do not double the dose to catch up.||
1776|127|B|||
1776|128|R|STORAGE:  Store the unmixed vial in the refrigerator. Do not||
1776|129|R|freeze. Keep the medication in the original box to protect from||
1776|130|R|light. This medication may also be stored at room temperature if||
1776|131|R|needed. If the medication is stored at room temperature, do not||
1776|132|R|put it back in the refrigerator and discard after 12 months.||
1776|133|R|After the vial is mixed into solution, use it within 3 hours and||
1776|134|R|discard any unused portion. Keep all medications away from||
1776|135|R|children and pets.||
1776|136|R|   Do not flush medications down the toilet or pour them into a||
1776|137|R|drain unless instructed to do so. Properly discard this product||
1776|138|R|when it is expired or no longer needed. Consult your pharmacist||
1776|139|R|or local waste disposal company.||
1776|140|B|||
1776|141|M|MEDICAL ALERT:  Your condition can cause complications in a||
1776|142|M|medical emergency. For information about enrolling in MedicAlert,||
1776|143|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1776|144|B|||
1776|145|A|Information last revised September 2025.||
1776|146|A|Copyright(c) 2025 First Databank, Inc.||
1776|147|B|||
1777|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1777|002|Z|does NOT have all possible information about this product. This||
1777|003|Z|information does not assure that this product is safe, effective,||
1777|004|Z|or appropriate for you. This information is not individual||
1777|005|Z|medical advice and does not substitute for the advice of your||
1777|006|Z|health care professional. Always ask your health care||
1777|007|Z|professional for complete information about this product and your||
1777|008|Z|specific health needs.||
1777|009|B|||
1777|010|T|SOFOSBUVIR/VELPATASVIR - ORAL||
1777|011|F|(soe-FOS-bue-vir/vel-PAT-as-vir)||
1777|012|B|||
1777|013|C|COMMON BRAND NAME(S): Epclusa||
1777|014|B|||
1777|015|W|WARNING:  Although this medication is used to treat hepatitis C,||
1777|016|W|it may rarely make another liver problem called hepatitis B get||
1777|017|W|worse. Before starting this medication, tell your doctor if you||
1777|018|W|have ever had hepatitis B. Tell your doctor right away if you||
1777|019|W|have new or worsening symptoms of liver disease, such as||
1777|020|W|nausea/vomiting that doesn't stop, loss of appetite,||
1777|021|W|stomach/abdominal pain, dark urine or yellowing eyes/skin.||
1777|022|B|||
1777|023|U|USES:  This medication is a combination of sofosbuvir and||
1777|024|U|velpatasvir and is used to treat chronic (long-lasting) hepatitis||
1777|025|U|C, a viral infection of the liver. It may sometimes be used with||
1777|026|U|another antiviral medication (ribavirin). These drugs work by||
1777|027|U|reducing the amount of hepatitis C virus in your body, which||
1777|028|U|helps your immune system fight the infection and may help your||
1777|029|U|liver recover. Chronic hepatitis C infection can cause serious||
1777|030|U|liver problems such as scarring (cirrhosis), or liver cancer.||
1777|031|U|   It is not known if this treatment can prevent you from passing||
1777|032|U|the virus to others. Do not share needles, and practice "safer||
1777|033|U|sex" (including the use of latex condoms) to lower the risk of||
1777|034|U|passing the virus to others.||
1777|035|B|||
1777|036|H|HOW TO USE:  Read the Patient Information Leaflet and||
1777|037|H|Instructions for Use if available from your pharmacist before you||
1777|038|H|start taking sofosbuvir/velpatasvir and each time you get a||
1777|039|H|refill. If you have any questions, ask your doctor or pharmacist.||
1777|040|H|   Take this medication by mouth with or without food as directed||
1777|041|H|by your doctor, usually once daily. Children's dosage is based on||
1777|042|H|age and weight. The manufacturer recommends that children younger||
1777|043|H|than 6 years old take the pellet form of this medication with||
1777|044|H|food to improve taste of the medication.||
1777|045|H|   If you are using the pellet form of this medication, gently||
1777|046|H|shake the packet before use. To take this medication without||
1777|047|H|food, open the packet and pour the pellets directly into your||
1777|048|H|mouth. To prevent a bitter taste, swallow the pellets without||
1777|049|H|chewing. You may drink water after swallowing the pellets if||
1777|050|H|needed. Repeat these steps if your dose is for more than one||
1777|051|H|packet. If you are taking this medication with food, open the||
1777|052|H|packet(s) and pour the pellets into a small bowl with one or more||
1777|053|H|spoonfuls of non-acidic soft food (such as pudding, mashed||
1777|054|H|potato, ice cream). The soft food should be at or below room||
1777|055|H|temperature. After gently mixing, take all of the mixture without||
1777|056|H|chewing within 15 minutes. Chewing or waiting to give the dose||
1777|057|H|may make this medication taste bitter.||
1777|058|H|   This medication works best when the amount of drug in your||
1777|059|H|body is kept at a constant level. Take this drug at evenly spaced||
1777|060|H|intervals. To help you remember, take it at the same time each||
1777|061|H|day.||
1777|062|H|   Continue to take sofosbuvir/velpatasvir for the full length of||
1777|063|H|time prescribed, even if symptoms disappear after a short time.||
1777|064|H|Stopping the medication too early may result in a return of the||
1777|065|H|infection.||
1777|066|H|   Antacids lower the absorption of velpatasvir. If you are||
1777|067|H|taking an antacid, take it at least 4 hours before or 4 hours||
1777|068|H|after this medication.||
1777|069|H|   Other acid-lowering medications for indigestion, heartburn, or||
1777|070|H|ulcers (such as prescription or over-the-counter medications||
1777|071|H|including famotidine, omeprazole) may prevent velpatasvir from||
1777|072|H|working. Ask your doctor or pharmacist how to use these||
1777|073|H|medications safely.||
1777|074|B|||
1777|075|S|SIDE EFFECTS:  See also Warning section.||
1777|076|S|   Tiredness, headache, nausea, diarrhea, or difficulty sleeping||
1777|077|S|may occur. If any of these effects last or get worse, tell your||
1777|078|S|doctor or pharmacist promptly.||
1777|079|S|   Remember that this medication has been prescribed because your||
1777|080|S|doctor has judged that the benefit to you is greater than the||
1777|081|S|risk of side effects. Many people using this medication do not||
1777|082|S|have serious side effects.||
1777|083|S|   A very serious allergic reaction to this drug is rare.||
1777|084|S|However, get medical help right away if you notice any symptoms||
1777|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1777|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1777|087|S|breathing.||
1777|088|S|   This is not a complete list of possible side effects. If you||
1777|089|S|notice other effects not listed above, contact your doctor or||
1777|090|S|pharmacist.||
1777|091|S|   In the US -||
1777|092|S|   Call your doctor for medical advice about side effects. You||
1777|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1777|094|S|www.fda.gov/medwatch.||
1777|095|S|   In Canada - Call your doctor for medical advice about side||
1777|096|S|effects. You may report side effects to Health Canada at||
1777|097|S|1-866-234-2345.||
1777|098|B|||
1777|099|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1777|100|P|pharmacist if you are allergic to sofosbuvir or velpatasvir; or||
1777|101|P|if you have any other allergies. This product may contain||
1777|102|P|inactive ingredients, which can cause allergic reactions or other||
1777|103|P|problems. Talk to your pharmacist for more details.||
1777|104|P|   Before using this medication, tell your doctor or pharmacist||
1777|105|P|your medical history, especially of: other liver problems (such||
1777|106|P|as hepatitis B), diabetes.||
1777|107|P|   If you have diabetes, your blood sugar may be lower with||
1777|108|P|hepatitis C treatment. This can increase your risk of low blood||
1777|109|P|sugar, so your doctor may adjust your diabetes treatment plan.||
1777|110|P|Tell your doctor right away if you have symptoms of low blood||
1777|111|P|sugar such as sudden sweating, shaking, fast heartbeat, hunger,||
1777|112|P|blurred vision, dizziness, or tingling hands/feet.||
1777|113|P|   Before having surgery, tell your doctor or dentist about all||
1777|114|P|the products you use (including prescription drugs,||
1777|115|P|nonprescription drugs, and herbal products).||
1777|116|P|   Children may be more sensitive to the side effects of this||
1777|117|P|drug, especially vomiting.||
1777|118|P|   During pregnancy, this medication should be used only when||
1777|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
1777|120|P|Sofosbuvir/velpatasvir, in combination with ribavirin, must not||
1777|121|P|be used during pregnancy by either the pregnant woman or her male||
1777|122|P|partner. The combination may harm an unborn baby. Reliable forms||
1777|123|P|of birth control must be used whenever at least one sexual||
1777|124|P|partner is using these medicines together. Female patients should||
1777|125|P|keep using birth control for 9 months after stopping treatment.||
1777|126|P|Male patients should keep using birth control for 6 months after||
1777|127|P|stopping treatment. If you or your partner becomes pregnant, or||
1777|128|P|if you think you or your partner may be pregnant, tell your||
1777|129|P|doctor right away.||
1777|130|P|   It is unknown if this medication passes into breast milk.||
1777|131|P|Consult your doctor before breastfeeding.||
1777|132|B|||
1777|133|I|DRUG INTERACTIONS:  See also How to Use section.||
1777|134|I|   Drug interactions may change how your medications work or||
1777|135|I|increase your risk for serious side effects. This document does||
1777|136|I|not contain all possible drug interactions. Keep a list of all||
1777|137|I|the products you use (including prescription/nonprescription||
1777|138|I|drugs and herbal products) and share it with your doctor and||
1777|139|I|pharmacist. Do not start, stop, or change the dosage of any||
1777|140|I|medicines without your doctor's approval.||
1777|141|I|   A product that may interact with this drug is: amiodarone.||
1777|142|I|   This medication can slow down the removal of other medications||
1777|143|I|from your body, which may affect how they work. One example is||
1777|144|I|topotecan, among others.||
1777|145|I|   Other medications can affect the removal of||
1777|146|I|sofosbuvir/velpatasvir from your body, which may affect how this||
1777|147|I|medication works. Examples include apalutamide, efavirenz,||
1777|148|I|rifamycins (such as rifampin, rifabutin), St. John's wort,||
1777|149|I|tipranavir/ritonavir, drugs used to treat seizures (such as||
1777|150|I|phenobarbital, carbamazepine, phenytoin, primidone), among||
1777|151|I|others.||
1777|152|I|   Do not take this medication with other products that contain||
1777|153|I|sofosbuvir.||
1777|154|B|||
1777|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1777|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1777|157|O|poison control center right away. US residents can call||
1777|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1777|159|B|||
1777|160|N|NOTES:  Do not share this medication with others.||
1777|161|N|   Lab tests (such as liver function, tests for hepatitis B and||
1777|162|N|C) should be done before you start using this medication, while||
1777|163|N|you are using it, and after completing treatment. Keep all||
1777|164|N|medical and lab appointments.||
1777|165|N|   If you are using this medication with ribavirin, it is||
1777|166|N|recommended that female patients or female partners of male||
1777|167|N|patients take a pregnancy test before starting this medication.||
1777|168|N|Pregnancy tests should continue to be done while using this||
1777|169|N|medication and for some time after this medication is stopped to||
1777|170|N|make sure no pregnancy occurs (for 9 months for female patients||
1777|171|N|and for 6 months for female partners of male patients).||
1777|172|B|||
1777|173|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1777|174|D|remember. If it is near the time of the next dose, skip the||
1777|175|D|missed dose. Take your next dose at the regular time. Do not||
1777|176|D|double the dose to catch up.||
1777|177|B|||
1777|178|R|STORAGE:  Store at room temperature away from light and moisture.||
1777|179|R|Store the tablets in the original container. For the pellets, do||
1777|180|R|not open the packets until you are ready to use the medication.||
1777|181|R|Do not store in the bathroom. Keep all medications away from||
1777|182|R|children and pets.||
1777|183|R|   Do not flush medications down the toilet or pour them into a||
1777|184|R|drain unless instructed to do so. Properly discard this product||
1777|185|R|when it is expired or no longer needed. Consult your pharmacist||
1777|186|R|or local waste disposal company.||
1777|187|B|||
1777|188|A|Information last revised July 2024.||
1777|189|A|Copyright(c) 2025 First Databank, Inc.||
1777|190|B|||
1779|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1779|002|Z|does NOT have all possible information about this product. This||
1779|003|Z|information does not assure that this product is safe, effective,||
1779|004|Z|or appropriate for you. This information is not individual||
1779|005|Z|medical advice and does not substitute for the advice of your||
1779|006|Z|health care professional. Always ask your health care||
1779|007|Z|professional for complete information about this product and your||
1779|008|Z|specific health needs.||
1779|009|B|||
1779|010|T|LIFITEGRAST - OPHTHALMIC||
1779|011|F|(LIF-i-TEG-rast)||
1779|012|B|||
1779|013|C|COMMON BRAND NAME(S): Xiidra||
1779|014|B|||
1779|015|U|USES:  This medication is used to treat dry eye disease.||
1779|016|B|||
1779|017|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1779|018|H|from your pharmacist before you start using lifitegrast and each||
1779|019|H|time you get a refill. If you have any questions, ask your doctor||
1779|020|H|or pharmacist.||
1779|021|H|   Use this medication in the affected eye(s) as directed by your||
1779|022|H|doctor, usually twice daily (once every 12 hours).||
1779|023|H|   To apply eye drops, wash hands first. To avoid contamination,||
1779|024|H|do not touch the tip of the single-use container or let it touch||
1779|025|H|your eye or any other surface.||
1779|026|H|   Do not open the single-use container until you are ready to||
1779|027|H|use it. After use, throw away the remaining contents of the||
1779|028|H|container right away.||
1779|029|H|   If you are wearing contact lenses, remove them before using||
1779|030|H|eye drops. Wait at least 15 minutes before replacing your contact||
1779|031|H|lenses. Tilt your head back, look upward, and pull down the lower||
1779|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1779|033|H|and place one drop into the pouch. Look downward, gently close||
1779|034|H|your eyes, and place one finger at the corner of your eye (near||
1779|035|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
1779|036|H|opening your eyes. This will prevent the medication from draining||
1779|037|H|out. Try not to blink or rub your eye. Repeat these steps if your||
1779|038|H|dose is for more than one drop. If directed to use this||
1779|039|H|medication in both eyes, repeat these steps for your other eye.||
1779|040|H|   Use eye drops before eye ointments to allow the drops to enter||
1779|041|H|the eye.||
1779|042|H|   Wait several minutes for your vision to clear before driving||
1779|043|H|or operating machinery.||
1779|044|H|   Use this medication regularly to get the most benefit from it.||
1779|045|H|To help you remember, use it at the same times each day.||
1779|046|H|   Tell your doctor if your condition lasts or gets worse.||
1779|047|B|||
1779|048|S|SIDE EFFECTS:  Eye discomfort, temporary blurred vision, or an||
1779|049|S|unusual taste sensation may occur. If any of these effects last||
1779|050|S|or get worse, tell your doctor or pharmacist promptly.||
1779|051|S|   Remember that this medication has been prescribed because your||
1779|052|S|doctor has judged that the benefit to you is greater than the||
1779|053|S|risk of side effects. Many people using this medication do not||
1779|054|S|have serious side effects.||
1779|055|S|   A very serious allergic reaction to this drug is rare.||
1779|056|S|However, get medical help right away if you notice any symptoms||
1779|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1779|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1779|059|S|breathing.||
1779|060|S|   This is not a complete list of possible side effects. If you||
1779|061|S|notice other effects not listed above, contact your doctor or||
1779|062|S|pharmacist.||
1779|063|S|   In the US -||
1779|064|S|   Call your doctor for medical advice about side effects. You||
1779|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1779|066|S|www.fda.gov/medwatch.||
1779|067|S|   In Canada - Call your doctor for medical advice about side||
1779|068|S|effects. You may report side effects to Health Canada at||
1779|069|S|1-866-234-2345.||
1779|070|B|||
1779|071|P|PRECAUTIONS:  Before using lifitegrast, tell your doctor or||
1779|072|P|pharmacist if you are allergic to it; or if you have any other||
1779|073|P|allergies. This product may contain inactive ingredients, which||
1779|074|P|can cause allergic reactions or other problems. Talk to your||
1779|075|P|pharmacist for more details.||
1779|076|P|   Before using this medication, tell your doctor or pharmacist||
1779|077|P|your medical history.||
1779|078|P|   After you apply this drug, your vision may become temporarily||
1779|079|P|blurred. Do not drive, use machinery, or do anything that needs||
1779|080|P|clear vision until you can do it safely.||
1779|081|P|   Before having surgery, tell your doctor or dentist about all||
1779|082|P|the products you use (including prescription drugs,||
1779|083|P|nonprescription drugs, and herbal products).||
1779|084|P|   During pregnancy, this medication should be used only when||
1779|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
1779|086|P|   It is unknown if this drug passes into breast milk. Consult||
1779|087|P|your doctor before breastfeeding.||
1779|088|B|||
1779|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1779|090|I|medications work or increase your risk for serious side effects.||
1779|091|I|This document does not contain all possible drug interactions.||
1779|092|I|Keep a list of all the products you use (including||
1779|093|I|prescription/nonprescription drugs and herbal products) and share||
1779|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
1779|095|I|the dosage of any medicines without your doctor's approval.||
1779|096|B|||
1779|097|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1779|098|O|has overdosed and has serious symptoms such as passing out or||
1779|099|O|trouble breathing, call 911. Otherwise, call a poison control||
1779|100|O|center right away. US residents can call 1-800-222-1222. Canada||
1779|101|O|residents can call 1-844-764-7669.||
1779|102|B|||
1779|103|N|NOTES:  Do not share this medication with others.||
1779|104|B|||
1779|105|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1779|106|D|If it is near the time of the next dose, skip the missed dose.||
1779|107|D|Use your next dose at the regular time. Do not double the dose to||
1779|108|D|catch up.||
1779|109|B|||
1779|110|R|STORAGE:  Store at room temperature away from light. Keep the||
1779|111|R|medication in the original foil pouch until ready to use. Keep||
1779|112|R|all medications away from children and pets.||
1779|113|R|   Do not flush medications down the toilet or pour them into a||
1779|114|R|drain unless instructed to do so. Properly discard this product||
1779|115|R|when it is expired or no longer needed. Consult your pharmacist||
1779|116|R|or local waste disposal company.||
1779|117|B|||
1779|118|A|Information last revised July 2024.||
1779|119|A|Copyright(c) 2025 First Databank, Inc.||
1779|120|B|||
1782|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1782|002|Z|does NOT have all possible information about this product. This||
1782|003|Z|information does not assure that this product is safe, effective,||
1782|004|Z|or appropriate for you. This information is not individual||
1782|005|Z|medical advice and does not substitute for the advice of your||
1782|006|Z|health care professional. Always ask your health care||
1782|007|Z|professional for complete information about this product and your||
1782|008|Z|specific health needs.||
1782|009|B|||
1782|010|T|RIBOFLAVIN - ORAL||
1782|011|F|(RYE-boe-flay-vin)||
1782|012|B|||
1782|013|U|USES:  Riboflavin (vitamin B2) is used to prevent or treat low||
1782|014|U|levels of vitamin B2 in people who do not get enough of the||
1782|015|U|vitamin from their diet. Most people who eat a normal diet do not||
1782|016|U|need extra vitamin B2. However, some conditions (such as||
1782|017|U|stomach/intestinal problems, prolonged infection, liver disease,||
1782|018|U|alcoholism, cancer) can cause low levels of vitamin B2. Vitamin||
1782|019|U|B2 plays an important role in the body. It is needed to keep your||
1782|020|U|skin, eyes, nerves, and red blood cells healthy.||
1782|021|B|||
1782|022|H|HOW TO USE:  Take this vitamin by mouth. Read and follow all||
1782|023|H|directions on the product package before taking this vitamin. If||
1782|024|H|you have any questions, ask your pharmacist. If your doctor has||
1782|025|H|prescribed this vitamin, take it as directed.||
1782|026|H|   If you are using the liquid form of this medication, shake the||
1782|027|H|bottle well before each dose. Carefully measure the dose using a||
1782|028|H|special measuring device/spoon. Do not use a household spoon||
1782|029|H|because you may not get the correct dose.||
1782|030|H|   The dosage is based on your medical condition and response to||
1782|031|H|treatment. Take this vitamin regularly to get the most benefit||
1782|032|H|from it. To help you remember, take it at the same time(s) each||
1782|033|H|day.||
1782|034|H|   If your condition lasts or gets worse, or if you think you may||
1782|035|H|have a serious medical problem, get medical help right away.||
1782|036|B|||
1782|037|S|SIDE EFFECTS:  This vitamin may cause your urine to turn bright||
1782|038|S|yellow. This effect is harmless and will disappear when the||
1782|039|S|vitamin is stopped.||
1782|040|S|   If your doctor has directed you to use this medication,||
1782|041|S|remember that your doctor has judged that the benefit to you is||
1782|042|S|greater than the risk of side effects. Many people using this||
1782|043|S|medication do not have serious side effects.||
1782|044|S|   A very serious allergic reaction to this vitamin is rare.||
1782|045|S|However, get medical help right away if you notice any symptoms||
1782|046|S|of a serious allergic reaction, including: rash, itching/swelling||
1782|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1782|048|S|breathing.||
1782|049|S|   This is not a complete list of possible side effects. If you||
1782|050|S|notice other effects not listed above, contact your doctor or||
1782|051|S|pharmacist.||
1782|052|S|   In the US -||
1782|053|S|   Call your doctor for medical advice about side effects. You||
1782|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1782|055|S|www.fda.gov/medwatch.||
1782|056|S|   In Canada - Call your doctor for medical advice about side||
1782|057|S|effects. You may report side effects to Health Canada at||
1782|058|S|1-866-234-2345.||
1782|059|B|||
1782|060|P|PRECAUTIONS:  Before taking riboflavin, tell your doctor or||
1782|061|P|pharmacist if you are allergic to it; or if you have any other||
1782|062|P|allergies. This product may contain inactive ingredients, which||
1782|063|P|can cause allergic reactions or other problems. Talk to your||
1782|064|P|pharmacist for more details.||
1782|065|P|   Before using this vitamin, tell your doctor or pharmacist your||
1782|066|P|medical history.||
1782|067|P|   Before having surgery, tell your doctor or dentist about all||
1782|068|P|the products you use (including prescription drugs,||
1782|069|P|nonprescription drugs, and herbal products).||
1782|070|P|   Tell your doctor if you are pregnant before using this||
1782|071|P|vitamin. Riboflavin is safe to take during pregnancy when used as||
1782|072|P|directed at recommended doses.||
1782|073|P|   Riboflavin passes into breast milk and is considered to be||
1782|074|P|safe during breastfeeding when used as directed at recommended||
1782|075|P|doses. Consult your doctor before breastfeeding.||
1782|076|B|||
1782|077|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1782|078|I|medications work or increase your risk for serious side effects.||
1782|079|I|This document does not contain all possible drug interactions.||
1782|080|I|Keep a list of all the products you use (including||
1782|081|I|prescription/nonprescription drugs and herbal products) and share||
1782|082|I|it with your doctor and pharmacist. Do not start, stop, or change||
1782|083|I|the dosage of any medicines without your doctor's approval.||
1782|084|I|   This vitamin may interfere with certain lab tests, possibly||
1782|085|I|causing false test results. Make sure lab personnel and all your||
1782|086|I|doctors know you use this vitamin.||
1782|087|B|||
1782|088|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1782|089|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1782|090|O|poison control center right away. US residents can call||
1782|091|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1782|092|B|||
1782|093|N|NOTES:  Keep all medical and lab appointments.||
1782|094|N|   This product is not a substitute for a proper diet. It is best||
1782|095|N|to get your vitamins from healthy foods. Riboflavin can be found||
1782|096|N|in milk, bread, fortified cereals, meat, green vegetables, and||
1782|097|N|other foods. Consult your doctor, pharmacist, or nutritionist for||
1782|098|N|more details.||
1782|099|B|||
1782|100|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1782|101|D|remember. If it is near the time of the next dose, skip the||
1782|102|D|missed dose. Take your next dose at the regular time. Do not||
1782|103|D|double the dose to catch up.||
1782|104|B|||
1782|105|R|STORAGE:  Check the product package for instructions on how to||
1782|106|R|store this vitamin, or ask your pharmacist. Keep all medications||
1782|107|R|away from children and pets.||
1782|108|R|   Do not flush medications down the toilet or pour them into a||
1782|109|R|drain unless instructed to do so. Properly discard this product||
1782|110|R|when it is expired or no longer needed. Consult your pharmacist||
1782|111|R|or local waste disposal company.||
1782|112|B|||
1782|113|A|Information last revised April 2025.||
1782|114|A|Copyright(c) 2025 First Databank, Inc.||
1782|115|B|||
1784|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1784|002|Z|does NOT have all possible information about this product. This||
1784|003|Z|information does not assure that this product is safe, effective,||
1784|004|Z|or appropriate for you. This information is not individual||
1784|005|Z|medical advice and does not substitute for the advice of your||
1784|006|Z|health care professional. Always ask your health care||
1784|007|Z|professional for complete information about this product and your||
1784|008|Z|specific health needs.||
1784|009|B|||
1784|010|T|CIPROFLOXACIN/FLUOCINOLONE - OTIC||
1784|011|F|(SIP-roe-FLOX-a-sin/FLOO-oh-SIN-oh-lone)||
1784|012|B|||
1784|013|C|COMMON BRAND NAME(S): Otovel||
1784|014|B|||
1784|015|U|USES:  This medication is used to treat ear infections for||
1784|016|U|children who have a tube in their ears. This medication contains||
1784|017|U|ciprofloxacin (a quinolone antibiotic) and fluocinolone (a||
1784|018|U|corticosteroid). This product works by stopping the growth of||
1784|019|U|bacteria and reducing ear inflammation and discomfort.||
1784|020|U|   This medication treats only bacterial ear infections. It will||
1784|021|U|not work for other types of ear infections. Using any antibiotic||
1784|022|U|when it is not needed can cause it to not work for future||
1784|023|U|infections.||
1784|024|B|||
1784|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1784|026|H|from the pharmacist before you start giving||
1784|027|H|ciprofloxacin/fluocinolone to your child and each time you get a||
1784|028|H|refill. If you have any questions, ask the doctor or pharmacist.||
1784|029|H|   Use this medication in the infected ear as directed by the||
1784|030|H|doctor, usually twice daily (every 12 hours). Use in the ear||
1784|031|H|only. Do not use in the eyes.||
1784|032|H|   To make sure that the right amount of medication is given, and||
1784|033|H|to avoid touching the ear with the dropper, a parent or caregiver||
1784|034|H|should give the drops if possible. To lower the risk of||
1784|035|H|dizziness, hold the container in your hand for 1 to 2 minutes in||
1784|036|H|order to warm it.||
1784|037|H|   To apply ear drops, wash your hands first. To avoid||
1784|038|H|contamination, do not touch the dropper tip or let it touch the||
1784|039|H|ear or any other surface. Have your child lie on his or her side||
1784|040|H|or tilt the affected ear upward. Hold the dropper directly over||
1784|041|H|the ear, and place all of the solution from one single-dose vial||
1784|042|H|into the ear canal. Gently press on the part of the ear called||
1784|043|H|the tragus 4 times to help the drops roll into the ear. Keep the||
1784|044|H|head tilted for about 1 minute, or insert a soft cotton plug if||
1784|045|H|so directed. If directed to use this medication in both ears,||
1784|046|H|repeat these steps for the other ear using a new single-dose||
1784|047|H|vial. Use a new single-dose vial for each dose.||
1784|048|H|   For the best effect, use this medication at evenly spaced||
1784|049|H|times. To help you remember, use this medication at the same||
1784|050|H|times every day.||
1784|051|H|   Continue giving this medication for the full time prescribed,||
1784|052|H|even if symptoms disappear after a few days. Stopping the||
1784|053|H|medication too early may result in a return of the infection.||
1784|054|H|   Tell the doctor if your child's condition lasts or gets worse||
1784|055|H|after 7 days.||
1784|056|B|||
1784|057|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1784|058|S|because the doctor has judged that the benefit to your child is||
1784|059|S|greater than the risk of side effects. Many people using this||
1784|060|S|medication do not have serious side effects.||
1784|061|S|   Use of this medication for prolonged or repeated periods may||
1784|062|S|result in a new fungal ear infection. Do not give this medication||
1784|063|S|for longer than prescribed. Contact the doctor if you notice new||
1784|064|S|or worsening symptoms.||
1784|065|S|   A very serious allergic reaction to this drug is rare.||
1784|066|S|However, get medical help right away if you notice any symptoms||
1784|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1784|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1784|069|S|breathing.||
1784|070|S|   This is not a complete list of possible side effects. If you||
1784|071|S|notice other effects not listed above, contact the doctor or||
1784|072|S|pharmacist.||
1784|073|S|   In the US -||
1784|074|S|   Call your doctor for medical advice about side effects. You||
1784|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1784|076|S|www.fda.gov/medwatch.||
1784|077|S|   In Canada - Call your doctor for medical advice about side||
1784|078|S|effects. You may report side effects to Health Canada at||
1784|079|S|1-866-234-2345.||
1784|080|B|||
1784|081|P|PRECAUTIONS:  Before using this medication, tell the doctor or||
1784|082|P|pharmacist if your child is allergic to quinolone antibiotics||
1784|083|P|(such as ciprofloxacin, levofloxacin), or to corticosteroids||
1784|084|P|(such as fluocinolone, prednisone); or if your child has any||
1784|085|P|other allergies. This product may contain inactive ingredients,||
1784|086|P|which can cause allergic reactions or other problems. Talk to the||
1784|087|P|pharmacist for more details.||
1784|088|P|   Before using this medication, tell the doctor or pharmacist||
1784|089|P|your child's medical history, especially of: an ear infection||
1784|090|P|caused by a virus (such as herpes simplex, chickenpox) or fungus.||
1784|091|P|   During pregnancy, this medication should be used only when||
1784|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
1784|093|P|   It is unknown if this medication passes into breast milk.||
1784|094|P|Consult your doctor before breastfeeding.||
1784|095|B|||
1784|096|I|DRUG INTERACTIONS:  Drug interactions may change how medications||
1784|097|I|work or increase the risk for serious side effects. This document||
1784|098|I|does not contain all possible drug interactions. Keep a list of||
1784|099|I|all the products your child uses (including||
1784|100|I|prescription/nonprescription drugs and herbal products) and share||
1784|101|I|it with the doctor and pharmacist. Do not start, stop, or change||
1784|102|I|the dosage of any medicines without the doctor's approval.||
1784|103|B|||
1784|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1784|105|O|has overdosed and has serious symptoms such as passing out or||
1784|106|O|trouble breathing, call 911. Otherwise, call a poison control||
1784|107|O|center right away. US residents can call 1-800-222-1222. Canada||
1784|108|O|residents can call 1-844-764-7669.||
1784|109|B|||
1784|110|N|NOTES:  Do not share this medication with others.||
1784|111|N|   This medication has been prescribed for your child's current||
1784|112|N|condition only. Do not use it later for another infection unless||
1784|113|N|your child's doctor tells you to.||
1784|114|N|   It is important to keep the infected ear(s) clean and dry. Try||
1784|115|N|not to get the infected ear(s) wet when bathing. Avoid swimming||
1784|116|N|unless the doctor tells you otherwise.||
1784|117|B|||
1784|118|D|MISSED DOSE:  If you miss a dose, give it as soon as you||
1784|119|D|remember. If it is near the time of the next dose, skip the||
1784|120|D|missed dose. Give the next dose at the regular time. Do not||
1784|121|D|double the dose to catch up.||
1784|122|B|||
1784|123|R|STORAGE:  Store at room temperature away from light. Keep the||
1784|124|R|medication in the original pouch until ready to use. Once the||
1784|125|R|pouch is opened, this medication expires after 7 days. Do not||
1784|126|R|open a vial until you are ready to give it and discard each vial||
1784|127|R|after use. Keep all medications away from children and pets.||
1784|128|R|   Do not flush medications down the toilet or pour them into a||
1784|129|R|drain unless instructed to do so. Properly discard this product||
1784|130|R|when it is expired or no longer needed. Consult the pharmacist or||
1784|131|R|local waste disposal company.||
1784|132|B|||
1784|133|A|Information last revised July 2024.||
1784|134|A|Copyright(c) 2025 First Databank, Inc.||
1784|135|B|||
1785|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1785|002|Z|does NOT have all possible information about this product. This||
1785|003|Z|information does not assure that this product is safe, effective,||
1785|004|Z|or appropriate for you. This information is not individual||
1785|005|Z|medical advice and does not substitute for the advice of your||
1785|006|Z|health care professional. Always ask your health care||
1785|007|Z|professional for complete information about this product and your||
1785|008|Z|specific health needs.||
1785|009|B|||
1785|010|T|LISINOPRIL SOLUTION - ORAL||
1785|011|F|(lye-SIN-oh-pril)||
1785|012|B|||
1785|013|C|COMMON BRAND NAME(S): Qbrelis||
1785|014|B|||
1785|015|W|WARNING:  This medication can cause serious (possibly fatal) harm||
1785|016|W|to an unborn baby if used during pregnancy. It is important to||
1785|017|W|prevent pregnancy while taking this medication. Consult your||
1785|018|W|doctor for more details and to discuss the use of reliable forms||
1785|019|W|of birth control while taking this medication. If you are||
1785|020|W|planning pregnancy, become pregnant, or think you may be||
1785|021|W|pregnant, tell your doctor right away.||
1785|022|B|||
1785|023|U|USES:  Lisinopril is used to treat high blood pressure. Lowering||
1785|024|U|high blood pressure helps prevent strokes, heart attacks, and||
1785|025|U|kidney problems. It is also used to treat heart failure and to||
1785|026|U|improve survival after a heart attack.||
1785|027|U|   Lisinopril belongs to a class of drugs known as ACE||
1785|028|U|inhibitors. It works by relaxing blood vessels so blood can flow||
1785|029|U|more easily.||
1785|030|B|||
1785|031|V|OTHER USES:  This section contains uses of this drug that are not||
1785|032|V|listed in the approved professional labeling for the drug but||
1785|033|V|that may be prescribed by your health care professional. Use this||
1785|034|V|drug for a condition that is listed in this section only if it||
1785|035|V|has been so prescribed by your health care professional.||
1785|036|V|   This medication may also be used for kidney disease and to||
1785|037|V|help protect the kidneys from harm due to diabetes.||
1785|038|B|||
1785|039|H|HOW TO USE:  Take this medication by mouth with or without food||
1785|040|H|as directed by your doctor, usually once daily.||
1785|041|H|   Carefully measure the dose using a special measuring||
1785|042|H|device/spoon. Do not use a household spoon because you may not||
1785|043|H|get the correct dose.||
1785|044|H|   The dosage is based on your medical condition and response to||
1785|045|H|treatment. Children's dosage is also based on weight.||
1785|046|H|   To reduce your risk of side effects, your doctor may direct||
1785|047|H|you to start this medication at a low dose and gradually increase||
1785|048|H|your dose. Follow your doctor's instructions carefully.||
1785|049|H|   Use this medication regularly to get the most benefit from it.||
1785|050|H|To help you remember, take it at the same time each day. Keep||
1785|051|H|taking this medication even if you feel well. Most people with||
1785|052|H|high blood pressure do not feel sick.||
1785|053|H|   For the treatment of high blood pressure, it may take 2 to 4||
1785|054|H|weeks before you get the full benefit of this medication. For the||
1785|055|H|treatment of heart failure, it may take weeks to months before||
1785|056|H|you get the full benefit of this medication. Tell your doctor if||
1785|057|H|your condition does not get better or if it gets worse (for||
1785|058|H|example, your blood pressure readings remain high or increase).||
1785|059|B|||
1785|060|S|SIDE EFFECTS:  Dizziness, lightheadedness, tiredness, or headache||
1785|061|S|may occur as your body adjusts to the medication. Dry cough may||
1785|062|S|also occur. If any of these effects last or get worse, tell your||
1785|063|S|doctor or pharmacist promptly.||
1785|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
1785|065|S|slowly when rising from a sitting or lying position.||
1785|066|S|   Remember that this medication has been prescribed because your||
1785|067|S|doctor has judged that the benefit to you is greater than the||
1785|068|S|risk of side effects. Many people using this medication do not||
1785|069|S|have serious side effects.||
1785|070|S|   Tell your doctor right away if you have any serious side||
1785|071|S|effects, including: fainting, symptoms of a high potassium blood||
1785|072|S|level (such as muscle weakness, slow/irregular heartbeat).||
1785|073|S|   Although lisinopril may be used to prevent kidney problems or||
1785|074|S|treat people who have kidney problems, it may also rarely cause||
1785|075|S|serious kidney problems or make them worse. Your doctor will||
1785|076|S|check your kidney function while you are taking lisinopril. Tell||
1785|077|S|your doctor right away if you have any signs of kidney problems||
1785|078|S|such as a change in the amount of urine.||
1785|079|S|   This drug may rarely cause serious (possibly fatal) liver||
1785|080|S|problems. Get medical help right away if you have any symptoms of||
1785|081|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1785|082|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1785|083|S|urine.||
1785|084|S|   A very serious allergic reaction to this drug is rare.||
1785|085|S|However, get medical help right away if you notice any symptoms||
1785|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1785|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1785|088|S|breathing.||
1785|089|S|   This is not a complete list of possible side effects. If you||
1785|090|S|notice other effects not listed above, contact your doctor or||
1785|091|S|pharmacist.||
1785|092|S|   In the US -||
1785|093|S|   Call your doctor for medical advice about side effects. You||
1785|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1785|095|S|www.fda.gov/medwatch.||
1785|096|S|   In Canada - Call your doctor for medical advice about side||
1785|097|S|effects. You may report side effects to Health Canada at||
1785|098|S|1-866-234-2345.||
1785|099|B|||
1785|100|P|PRECAUTIONS:  Before taking lisinopril, tell your doctor or||
1785|101|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
1785|102|P|(such as benazepril); or if you have any other allergies. This||
1785|103|P|product may contain inactive ingredients, which can cause||
1785|104|P|allergic reactions or other problems. Talk to your pharmacist for||
1785|105|P|more details.||
1785|106|P|   Before using this medication, tell your doctor or pharmacist||
1785|107|P|your medical history, especially of: history of an allergic||
1785|108|P|reaction which included swelling of the face/lips/tongue/throat||
1785|109|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
1785|110|P|dialysis), high level of potassium in the blood.||
1785|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1785|112|P|can make you more dizzy. Do not drive, use machinery, or do||
1785|113|P|anything that needs alertness until you can do it safely. Limit||
1785|114|P|alcoholic beverages. Talk to your doctor if you are using||
1785|115|P|marijuana (cannabis).||
1785|116|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
1785|117|P|and cause you to feel lightheaded. Tell your doctor if you have||
1785|118|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
1785|119|P|of fluids unless your doctor tells you not to.||
1785|120|P|   Before having surgery, tell your doctor or dentist about all||
1785|121|P|the products you use (including prescription drugs,||
1785|122|P|nonprescription drugs, and herbal products).||
1785|123|P|   This product may increase your potassium levels. Before using||
1785|124|P|potassium supplements or salt substitutes that contain potassium,||
1785|125|P|consult your doctor or pharmacist.||
1785|126|P|   Older adults may be more sensitive to the side effects of this||
1785|127|P|drug, especially dizziness and increases in potassium level.||
1785|128|P|   Tell your doctor if you are pregnant or plan to become||
1785|129|P|pregnant. You should not become pregnant while using lisinopril.||
1785|130|P|Lisinopril may harm an unborn baby. If you become pregnant, talk||
1785|131|P|to your doctor right away about the risks and benefits of this||
1785|132|P|medication. (See also Warning section.)||
1785|133|P|   It is unknown if this medication passes into breast milk.||
1785|134|P|Consult your doctor before breastfeeding.||
1785|135|B|||
1785|136|I|DRUG INTERACTIONS:  See also Precautions section.||
1785|137|I|   Drug interactions may change how your medications work or||
1785|138|I|increase your risk for serious side effects. This document does||
1785|139|I|not contain all possible drug interactions. Keep a list of all||
1785|140|I|the products you use (including prescription/nonprescription||
1785|141|I|drugs and herbal products) and share it with your doctor and||
1785|142|I|pharmacist. Do not start, stop, or change the dosage of any||
1785|143|I|medicines without your doctor's approval.||
1785|144|I|   Some products that may interact with this drug are: aliskiren,||
1785|145|I|certain drugs that weaken the immune system/increase the risk of||
1785|146|I|infection (such as everolimus, sirolimus), lithium, drugs that||
1785|147|I|may increase the level of potassium in the blood (such as ARBs||
1785|148|I|including losartan/valsartan, birth control pills containing||
1785|149|I|drospirenone), sacubitril.||
1785|150|I|   Some products have ingredients that could raise your blood||
1785|151|I|pressure or worsen your heart failure. Tell your pharmacist what||
1785|152|I|products you are using, and ask how to use them safely||
1785|153|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
1785|154|I|ibuprofen/naproxen).||
1785|155|I|   A very serious reaction may occur if you are getting||
1785|156|I|injections for bee/wasp sting allergy (desensitization) and are||
1785|157|I|also taking lisinopril. Make sure all your doctors know which||
1785|158|I|medicines you are using.||
1785|159|B|||
1785|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1785|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1785|162|O|poison control center right away. US residents can call||
1785|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1785|164|O|Symptoms of overdose may include: severe dizziness, fainting.||
1785|165|B|||
1785|166|N|NOTES:  Do not share this medication with others.||
1785|167|N|   Lifestyle changes that may help this medication work better||
1785|168|N|include exercising, stopping smoking, and eating a||
1785|169|N|low-cholesterol/low-fat diet. Consult your doctor for more||
1785|170|N|details.||
1785|171|N|   Lab and/or medical tests (such as kidney function, potassium||
1785|172|N|levels) should be done while you are taking this medication. Keep||
1785|173|N|all medical and lab appointments. Consult your doctor for more||
1785|174|N|details.||
1785|175|N|   Check your blood pressure and pulse (heart rate) regularly||
1785|176|N|while taking this medication. Learn how to check your own blood||
1785|177|N|pressure and pulse at home, and share the results with your||
1785|178|N|doctor.||
1785|179|B|||
1785|180|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1785|181|D|remember. If it is near the time of the next dose, skip the||
1785|182|D|missed dose. Take your next dose at the regular time. Do not||
1785|183|D|double the dose to catch up.||
1785|184|B|||
1785|185|R|STORAGE:  Store at room temperature away from heat. Do not||
1785|186|R|freeze. Keep all medications away from children and pets.||
1785|187|R|   Do not flush medications down the toilet or pour them into a||
1785|188|R|drain unless instructed to do so. Properly discard this product||
1785|189|R|when it is expired or no longer needed. Consult your pharmacist||
1785|190|R|or local waste disposal company.||
1785|191|B|||
1785|192|A|Information last revised October 2024.||
1785|193|A|Copyright(c) 2025 First Databank, Inc.||
1785|194|B|||
1787|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1787|002|Z|does NOT have all possible information about this product. This||
1787|003|Z|information does not assure that this product is safe, effective,||
1787|004|Z|or appropriate for you. This information is not individual||
1787|005|Z|medical advice and does not substitute for the advice of your||
1787|006|Z|health care professional. Always ask your health care||
1787|007|Z|professional for complete information about this product and your||
1787|008|Z|specific health needs.||
1787|009|B|||
1787|010|T|METHYLNALTREXONE - ORAL||
1787|011|F|(METH-il-nal-TREX-one)||
1787|012|B|||
1787|013|C|COMMON BRAND NAME(S): Relistor||
1787|014|B|||
1787|015|U|USES:  This medication is used to treat constipation caused by||
1787|016|U|opioid medication. It blocks the effect of opioids on the gut||
1787|017|U|without blocking the effect on pain. Methylnaltrexone belongs to||
1787|018|U|a class of medications known as opioid antagonists.||
1787|019|B|||
1787|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1787|021|H|pharmacist before you start taking methylnaltrexone and each time||
1787|022|H|you get a refill. If you have any questions, ask your doctor or||
1787|023|H|pharmacist.||
1787|024|H|   Take this medication by mouth on an empty stomach as directed||
1787|025|H|by your doctor, usually once daily at least 30 minutes before||
1787|026|H|your first meal of the day.||
1787|027|H|   The dosage is based on your medical condition and response to||
1787|028|H|treatment.||
1787|029|H|   Ask your doctor if you should keep using your usual||
1787|030|H|medications for constipation. This medication is used only for||
1787|031|H|constipation caused by opioids. Stop taking methylnaltrexone when||
1787|032|H|you stop using opioid pain medication unless otherwise directed||
1787|033|H|by your doctor.||
1787|034|H|   Make sure you are close to a bathroom after taking this||
1787|035|H|medication. This medication works quickly. Most people have a||
1787|036|H|bowel movement within a few minutes to a few hours after taking||
1787|037|H|this medication.||
1787|038|H|   Tell your doctor if your condition lasts or gets worse.||
1787|039|B|||
1787|040|S|SIDE EFFECTS:  Stomach/abdominal pain may occur. If this effect||
1787|041|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
1787|042|S|   Remember that this medication has been prescribed because your||
1787|043|S|doctor has judged that the benefit to you is greater than the||
1787|044|S|risk of side effects. Many people using this medication do not||
1787|045|S|have serious side effects.||
1787|046|S|   Stop taking methylnaltrexone and tell your doctor right away||
1787|047|S|if you have diarrhea that doesn't stop.||
1787|048|S|   Opioid withdrawal symptoms may occur in some people. Tell your||
1787|049|S|doctor right away if any of these withdrawal symptoms occur:||
1787|050|S|sweating, chills, abdominal cramps, diarrhea, mental/mood changes||
1787|051|S|(such as anxiety, confusion, extreme sleepiness, visual||
1787|052|S|hallucinations), yawning.||
1787|053|S|   This drug may rarely cause a serious tear in the stomach or||
1787|054|S|intestinal wall (perforation). Stop taking this medication and||
1787|055|S|get medical help right away if any of these very serious side||
1787|056|S|effects occur: severe stomach/abdominal pain that doesn't go||
1787|057|S|away, fever, severe dizziness, fainting, severe nausea/vomiting.||
1787|058|S|   A very serious allergic reaction to this drug is rare.||
1787|059|S|However, get medical help right away if you notice any symptoms||
1787|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1787|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1787|062|S|breathing.||
1787|063|S|   This is not a complete list of possible side effects. If you||
1787|064|S|notice other effects not listed above, contact your doctor or||
1787|065|S|pharmacist.||
1787|066|S|   In the US -||
1787|067|S|   Call your doctor for medical advice about side effects. You||
1787|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1787|069|S|www.fda.gov/medwatch.||
1787|070|S|   In Canada - Call your doctor for medical advice about side||
1787|071|S|effects. You may report side effects to Health Canada at||
1787|072|S|1-866-234-2345.||
1787|073|B|||
1787|074|P|PRECAUTIONS:  Before taking methylnaltrexone, tell your doctor or||
1787|075|P|pharmacist if you are allergic to it; or if you have any other||
1787|076|P|allergies. This product may contain inactive ingredients, which||
1787|077|P|can cause allergic reactions or other problems. Talk to your||
1787|078|P|pharmacist for more details.||
1787|079|P|   Before using this medication, tell your doctor or pharmacist||
1787|080|P|your medical history, especially of: stomach/intestinal problems||
1787|081|P|(such as blockage, ulcers, tumors, Crohn's disease,||
1787|082|P|diverticulitis), kidney disease, liver disease.||
1787|083|P|   Before having surgery, tell your doctor or dentist about all||
1787|084|P|the products you use (including prescription drugs,||
1787|085|P|nonprescription drugs, and herbal products).||
1787|086|P|   Older adults may be at greater risk for diarrhea while taking||
1787|087|P|this drug.||
1787|088|P|   During pregnancy, this medication should be used only when||
1787|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
1787|090|P|   It is unknown if this medication passes into breast milk.||
1787|091|P|Consult your doctor before breastfeeding.||
1787|092|B|||
1787|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1787|094|I|medications work or increase your risk for serious side effects.||
1787|095|I|This document does not contain all possible drug interactions.||
1787|096|I|Keep a list of all the products you use (including||
1787|097|I|prescription/nonprescription drugs and herbal products) and share||
1787|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
1787|099|I|the dosage of any medicines without your doctor's approval.||
1787|100|B|||
1787|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1787|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1787|103|O|poison control center right away. US residents can call||
1787|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1787|105|B|||
1787|106|N|NOTES:  Do not share this medication with others.||
1787|107|B|||
1787|108|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1787|109|D|remember. If it is near the time of the next dose, skip the||
1787|110|D|missed dose. Take your next dose at the regular time. Do not||
1787|111|D|double the dose to catch up.||
1787|112|B|||
1787|113|R|STORAGE:  Store at room temperature away from light and moisture.||
1787|114|R|Do not store in the bathroom. Keep all medications away from||
1787|115|R|children and pets.||
1787|116|R|   Do not flush medications down the toilet or pour them into a||
1787|117|R|drain unless instructed to do so. Properly discard this product||
1787|118|R|when it is expired or no longer needed. Consult your pharmacist||
1787|119|R|or local waste disposal company.||
1787|120|B|||
1787|121|A|Information last revised May 2024.||
1787|122|A|Copyright(c) 2025 First Databank, Inc.||
1787|123|B|||
1789|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1789|002|Z|does NOT have all possible information about this product. This||
1789|003|Z|information does not assure that this product is safe, effective,||
1789|004|Z|or appropriate for you. This information is not individual||
1789|005|Z|medical advice and does not substitute for the advice of your||
1789|006|Z|health care professional. Always ask your health care||
1789|007|Z|professional for complete information about this product and your||
1789|008|Z|specific health needs.||
1789|009|B|||
1789|010|T|ECONAZOLE FOAM - TOPICAL||
1789|011|F|(e-KON-a-zole)||
1789|012|B|||
1789|013|C|COMMON BRAND NAME(S): Ecoza||
1789|014|B|||
1789|015|U|USES:  Econazole foam is used to treat athlete's foot. Econazole||
1789|016|U|is an azole antifungal that works by preventing the growth of||
1789|017|U|fungus.||
1789|018|B|||
1789|019|V|OTHER USES:  This section contains uses of this drug that are not||
1789|020|V|listed in the approved professional labeling for the drug but||
1789|021|V|that may be prescribed by your health care professional. Use this||
1789|022|V|drug for a condition that is listed in this section only if it||
1789|023|V|has been so prescribed by your health care professional.||
1789|024|V|   This drug may also be used for other types of fungal skin||
1789|025|V|infections.||
1789|026|B|||
1789|027|H|HOW TO USE:  Read the Patient Information Leaflet and||
1789|028|H|Instructions for Use if available from your pharmacist before you||
1789|029|H|start using econazole and each time you get a refill. If you have||
1789|030|H|any questions, ask your doctor or pharmacist.||
1789|031|H|   Use this medication on the skin only. Clean and thoroughly dry||
1789|032|H|the area to be treated. Before using the medication, shake the||
1789|033|H|container well. Apply this medication on and around the affected||
1789|034|H|area as directed by your doctor, usually once a day. Do not apply||
1789|035|H|this medication more often or use for longer than prescribed.||
1789|036|H|   This medication is flammable until dry. Avoid smoking or being||
1789|037|H|near open flames while using the medication and until the||
1789|038|H|medication has dried.||
1789|039|H|   Wash your hands after using. Do not wrap, cover, or bandage||
1789|040|H|the area unless directed to do so by your doctor.||
1789|041|H|   Do not apply this medication in the eyes, nose, or mouth, or||
1789|042|H|inside the vagina. If you do get the medication in those areas,||
1789|043|H|flush with plenty of water.||
1789|044|H|   Use this medication regularly to get the most benefit from it.||
1789|045|H|To help you remember, use it at the same time each day.||
1789|046|H|   Continue to use this medication until the full prescribed||
1789|047|H|amount is finished, even if symptoms disappear after a few days.||
1789|048|H|Stopping the medication too early may result in a return of the||
1789|049|H|infection.||
1789|050|H|   Tell your doctor if your condition lasts after 4 weeks of||
1789|051|H|treatment or if it gets worse.||
1789|052|B|||
1789|053|S|SIDE EFFECTS:  Burning, stinging, irritation, or redness at the||
1789|054|S|application site may occur. If any of these effects last or get||
1789|055|S|worse, tell your doctor or pharmacist promptly.||
1789|056|S|   Remember that this medication has been prescribed because your||
1789|057|S|doctor has judged that the benefit to you is greater than the||
1789|058|S|risk of side effects. Many people using this medication do not||
1789|059|S|have serious side effects.||
1789|060|S|   A very serious allergic reaction to this drug is rare.||
1789|061|S|However, get medical help right away if you notice any symptoms||
1789|062|S|of a serious allergic reaction, including: rash, itching/swelling||
1789|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1789|064|S|breathing.||
1789|065|S|   This is not a complete list of possible side effects. If you||
1789|066|S|notice other effects not listed above, contact your doctor or||
1789|067|S|pharmacist.||
1789|068|S|   In the US -||
1789|069|S|   Call your doctor for medical advice about side effects. You||
1789|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1789|071|S|www.fda.gov/medwatch.||
1789|072|S|   In Canada - Call your doctor for medical advice about side||
1789|073|S|effects. You may report side effects to Health Canada at||
1789|074|S|1-866-234-2345.||
1789|075|B|||
1789|076|P|PRECAUTIONS:  Before using econazole, tell your doctor or||
1789|077|P|pharmacist if you are allergic to it; or to other azole||
1789|078|P|antifungals (such as clotrimazole, ketoconazole, miconazole); or||
1789|079|P|if you have any other allergies. This product may contain||
1789|080|P|inactive ingredients, which can cause allergic reactions or other||
1789|081|P|problems. Talk to your pharmacist for more details.||
1789|082|P|   Before using this medication, tell your doctor or pharmacist||
1789|083|P|your medical history.||
1789|084|P|   Before having surgery, tell your doctor or dentist about all||
1789|085|P|the products you use (including prescription drugs,||
1789|086|P|nonprescription drugs, and herbal products).||
1789|087|P|   During pregnancy, this medication should be used only when||
1789|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
1789|089|P|   It is unknown if this drug passes into breast milk. Consult||
1789|090|P|your doctor before breastfeeding.||
1789|091|B|||
1789|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1789|093|I|medications work or increase your risk for serious side effects.||
1789|094|I|This document does not contain all possible drug interactions.||
1789|095|I|Keep a list of all the products you use (including||
1789|096|I|prescription/nonprescription drugs and herbal products) and share||
1789|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
1789|098|I|the dosage of any medicines without your doctor's approval.||
1789|099|B|||
1789|100|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1789|101|O|has overdosed and has serious symptoms such as passing out or||
1789|102|O|trouble breathing, call 911. Otherwise, call a poison control||
1789|103|O|center right away. US residents can call 1-800-222-1222. Canada||
1789|104|O|residents can call 1-844-764-7669.||
1789|105|B|||
1789|106|N|NOTES:  Do not share this medication with others.||
1789|107|N|   This medication has been prescribed for your current condition||
1789|108|N|only. Do not use it later for another infection unless your||
1789|109|N|doctor tells you to.||
1789|110|B|||
1789|111|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1789|112|D|If it is near the time of the next dose, skip the missed dose.||
1789|113|D|Use your next dose at the regular time. Do not double the dose to||
1789|114|D|catch up.||
1789|115|B|||
1789|116|R|STORAGE:  Store at room temperature away from heat. Do not||
1789|117|R|refrigerate or freeze. Keep all medications away from children||
1789|118|R|and pets.||
1789|119|R|   Do not flush medications down the toilet or pour them into a||
1789|120|R|drain unless instructed to do so. Properly discard this product||
1789|121|R|when it is expired or no longer needed. Consult your pharmacist||
1789|122|R|or local waste disposal company.||
1789|123|B|||
1789|124|A|Information last revised July 2025.||
1789|125|A|Copyright(c) 2025 First Databank, Inc.||
1789|126|B|||
1790|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1790|002|Z|does NOT have all possible information about this product. This||
1790|003|Z|information does not assure that this product is safe, effective,||
1790|004|Z|or appropriate for you. This information is not individual||
1790|005|Z|medical advice and does not substitute for the advice of your||
1790|006|Z|health care professional. Always ask your health care||
1790|007|Z|professional for complete information about this product and your||
1790|008|Z|specific health needs.||
1790|009|B|||
1790|010|T|NITROGLYCERIN POWDER PACKET - SUBLINGUAL||
1790|011|F|(NYE-troe-GLIS-er-in)||
1790|012|B|||
1790|013|C|COMMON BRAND NAME(S): Gonitro||
1790|014|B|||
1790|015|U|USES:  This medication is used to relieve chest pain (angina) in||
1790|016|U|people that have a certain heart condition (coronary artery||
1790|017|U|disease). It may also be used before physical activities (such as||
1790|018|U|exercise, sexual activity) to help prevent chest pain.||
1790|019|U|   Nitroglycerin belongs to a class of drugs known as nitrates.||
1790|020|U|Angina occurs when the heart muscle is not getting enough blood.||
1790|021|U|This drug works by relaxing and widening blood vessels so blood||
1790|022|U|can flow more easily to the heart.||
1790|023|B|||
1790|024|H|HOW TO USE:  Ask your doctor now for exact instructions on how to||
1790|025|H|use your nitroglycerin and when to call for emergency medical||
1790|026|H|help (911).||
1790|027|H|   Carefully read the Instructions for Use if available from your||
1790|028|H|pharmacist before you start using nitroglycerin and each time you||
1790|029|H|get a refill. If you have any questions, ask your doctor or||
1790|030|H|pharmacist.||
1790|031|H|   If you are using this medication to relieve chest pain once it||
1790|032|H|occurs, use it as soon as possible. If your chest pain has not||
1790|033|H|improved or if it has worsened 5 minutes after you use this drug,||
1790|034|H|call emergency medical help (911).||
1790|035|H|   Sit down before using this medication. Holding the packet||
1790|036|H|upright and as close to your mouth as possible, tear open the||
1790|037|H|packet and pour all of the powder under your tongue. Close your||
1790|038|H|mouth right away and breathe normally through your nose. Let all||
1790|039|H|of the powder dissolve before you swallow. Do not rinse your||
1790|040|H|mouth or spit for 5 minutes after taking a dose.||
1790|041|H|   The dosage is based on your medical condition and response to||
1790|042|H|treatment. A dose of this medication may be either 1 or 2||
1790|043|H|packets. Follow your doctor's instructions about how many packets||
1790|044|H|you should take for each dose. After you take your first dose of||
1790|045|H|nitroglycerin powder, you may take 1 more packet every 5 minutes,||
1790|046|H|if needed. Do not take more than 3 packets of nitroglycerin||
1790|047|H|powder within 15 minutes.||
1790|048|H|   If you are using this medication to prevent chest pain before||
1790|049|H|physical activities, use it 5 to 10 minutes before the activity.||
1790|050|H|   If this medication is used very often, it may not work as||
1790|051|H|well. Talk with your doctor if this medication stops working||
1790|052|H|well.||
1790|053|B|||
1790|054|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, nausea,||
1790|055|S|flushing, and burning/tingling under the tongue may occur. If any||
1790|056|S|of these effects last or get worse, tell your doctor or||
1790|057|S|pharmacist promptly.||
1790|058|S|   Headache is often a sign that this medication is working. Your||
1790|059|S|doctor may recommend treating headaches with an over-the-counter||
1790|060|S|pain reliever (such as acetaminophen, aspirin). If the headaches||
1790|061|S|continue or become severe, tell your doctor promptly.||
1790|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
1790|063|S|slowly when rising from a sitting or lying position.||
1790|064|S|   Remember that this medication has been prescribed because your||
1790|065|S|doctor has judged that the benefit to you is greater than the||
1790|066|S|risk of side effects. Many people using this medication do not||
1790|067|S|have serious side effects.||
1790|068|S|   Tell your doctor right away if you have any serious side||
1790|069|S|effects, including: fainting, fast/irregular/pounding heartbeat.||
1790|070|S|   A very serious allergic reaction to this drug is rare.||
1790|071|S|However, get medical help right away if you notice any symptoms||
1790|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1790|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1790|074|S|breathing.||
1790|075|S|   This is not a complete list of possible side effects. If you||
1790|076|S|notice other effects not listed above, contact your doctor or||
1790|077|S|pharmacist.||
1790|078|S|   In the US -||
1790|079|S|   Call your doctor for medical advice about side effects. You||
1790|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1790|081|S|www.fda.gov/medwatch.||
1790|082|S|   In Canada - Call your doctor for medical advice about side||
1790|083|S|effects. You may report side effects to Health Canada at||
1790|084|S|1-866-234-2345.||
1790|085|B|||
1790|086|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1790|087|P|pharmacist if you are allergic to it; or to similar drugs (such||
1790|088|P|as isosorbide mononitrate); or to nitrites; or if you have any||
1790|089|P|other allergies. This product may contain inactive ingredients,||
1790|090|P|which can cause allergic reactions or other problems. Talk to||
1790|091|P|your pharmacist for more details.||
1790|092|P|   Before using this medication, tell your doctor or pharmacist||
1790|093|P|your medical history, especially of: recent head injury, anemia,||
1790|094|P|low blood pressure, other heart problems (such as recent heart||
1790|095|P|attack).||
1790|096|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1790|097|P|can make you more dizzy. Do not drive, use machinery, or do||
1790|098|P|anything that needs alertness until you can do it safely. Limit||
1790|099|P|alcoholic beverages. Talk to your doctor if you are using||
1790|100|P|marijuana (cannabis).||
1790|101|P|   Before having surgery, tell your doctor or dentist about all||
1790|102|P|the products you use (including prescription drugs,||
1790|103|P|nonprescription drugs, and herbal products).||
1790|104|P|   Older adults may be more sensitive to the side effects of this||
1790|105|P|medication, especially dizziness and lightheadedness, which could||
1790|106|P|increase the risk of falls.||
1790|107|P|   During pregnancy, this medication should be used only when||
1790|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
1790|109|P|   It is unknown if this medication passes into breast milk or if||
1790|110|P|it may harm a nursing infant. Consult your doctor before||
1790|111|P|breastfeeding.||
1790|112|B|||
1790|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1790|114|I|medications work or increase your risk for serious side effects.||
1790|115|I|This document does not contain all possible drug interactions.||
1790|116|I|Keep a list of all the products you use (including||
1790|117|I|prescription/nonprescription drugs and herbal products) and share||
1790|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
1790|119|I|the dosage of any medicines without your doctor's approval.||
1790|120|I|   Some products that may interact with this drug are: drugs used||
1790|121|I|to treat erectile dysfunction-ED or pulmonary hypertension (such||
1790|122|I|as sildenafil, tadalafil), certain drugs to treat migraine||
1790|123|I|headaches (ergot alkaloids such as ergotamine), riociguat,||
1790|124|I|vericiguat.||
1790|125|I|   This medication may interfere with certain lab tests (such as||
1790|126|I|blood cholesterol levels), possibly causing false test results.||
1790|127|I|Make sure lab personnel and all your doctors know you use this||
1790|128|I|drug.||
1790|129|B|||
1790|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1790|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1790|132|O|poison control center right away. US residents can call||
1790|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1790|134|O|Symptoms of overdose may include: slow heartbeat, vision changes,||
1790|135|O|severe nausea/vomiting, sweating, cold/clammy skin, bluish||
1790|136|O|fingers/toes/lips.||
1790|137|B|||
1790|138|N|NOTES:  Do not share this medication with others.||
1790|139|B|||
1790|140|D|MISSED DOSE:  Not applicable.||
1790|141|B|||
1790|142|R|STORAGE:  Store at room temperature away from light and moisture.||
1790|143|R|Do not store in the bathroom. Keep all medications away from||
1790|144|R|children and pets.||
1790|145|R|   Do not flush medications down the toilet or pour them into a||
1790|146|R|drain unless instructed to do so. Properly discard this product||
1790|147|R|when it is expired or no longer needed. Consult your pharmacist||
1790|148|R|or local waste disposal company.||
1790|149|B|||
1790|150|M|MEDICAL ALERT:  Your condition can cause complications in a||
1790|151|M|medical emergency. For information about enrolling in MedicAlert,||
1790|152|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1790|153|B|||
1790|154|A|Information last revised May 2024.||
1790|155|A|Copyright(c) 2025 First Databank, Inc.||
1790|156|B|||
1791|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1791|002|Z|does NOT have all possible information about this product. This||
1791|003|Z|information does not assure that this product is safe, effective,||
1791|004|Z|or appropriate for you. This information is not individual||
1791|005|Z|medical advice and does not substitute for the advice of your||
1791|006|Z|health care professional. Always ask your health care||
1791|007|Z|professional for complete information about this product and your||
1791|008|Z|specific health needs.||
1791|009|B|||
1791|010|T|ETEPLIRSEN - INJECTION||
1791|011|F|(e-TEP-lir-sen)||
1791|012|B|||
1791|013|C|COMMON BRAND NAME(S): Exondys 51||
1791|014|B|||
1791|015|U|USES:  Eteplirsen is used to treat a certain inherited muscle||
1791|016|U|disorder (Duchenne muscular dystrophy-DMD). This disorder is||
1791|017|U|caused by a lack of a certain muscle protein (dystrophin). This||
1791|018|U|medication can increase the amount of dystrophin in your body.||
1791|019|B|||
1791|020|H|HOW TO USE:  This medication is given by injection into a vein by||
1791|021|H|a health care professional as directed by your doctor. It is||
1791|022|H|usually given once every week over 35 to 60 minutes. The dosage||
1791|023|H|is based on your weight.||
1791|024|H|   Tell your doctor if your condition does not get better or if||
1791|025|H|it gets worse.||
1791|026|B|||
1791|027|S|SIDE EFFECTS:  Pain at injection site, dizziness, vomiting, or||
1791|028|S|joint pain may occur. If any of these effects last or get worse,||
1791|029|S|tell your doctor or pharmacist promptly.||
1791|030|S|   Remember that this medication has been prescribed because your||
1791|031|S|doctor has judged that the benefit to you is greater than the||
1791|032|S|risk of side effects. Many people using this medication do not||
1791|033|S|have serious side effects.||
1791|034|S|   A very serious allergic reaction to this drug is rare.||
1791|035|S|However, get medical help right away if you notice any symptoms||
1791|036|S|of a serious allergic reaction, including: chest pain, fast||
1791|037|S|heartbeat, cough, rash, itching/swelling (especially of the||
1791|038|S|face/tongue/throat), severe dizziness, trouble breathing.||
1791|039|S|   This is not a complete list of possible side effects. If you||
1791|040|S|notice other effects not listed above, contact your doctor or||
1791|041|S|pharmacist.||
1791|042|S|   In the US -||
1791|043|S|   Call your doctor for medical advice about side effects. You||
1791|044|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1791|045|S|www.fda.gov/medwatch.||
1791|046|S|   In Canada - Call your doctor for medical advice about side||
1791|047|S|effects. You may report side effects to Health Canada at||
1791|048|S|1-866-234-2345.||
1791|049|B|||
1791|050|P|PRECAUTIONS:  Before using eteplirsen, tell your doctor or||
1791|051|P|pharmacist if you are allergic to it; or if you have any other||
1791|052|P|allergies. This product may contain inactive ingredients, which||
1791|053|P|can cause allergic reactions or other problems. Talk to your||
1791|054|P|pharmacist for more details.||
1791|055|P|   Before using this medication, tell your doctor or pharmacist||
1791|056|P|your medical history.||
1791|057|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1791|058|P|can make you more dizzy. Do not drive, use machinery, or do||
1791|059|P|anything that needs alertness until you can do it safely. Limit||
1791|060|P|alcoholic beverages. Talk to your doctor if you are using||
1791|061|P|marijuana (cannabis).||
1791|062|P|   Before having surgery, tell your doctor or dentist about all||
1791|063|P|the products you use (including prescription drugs,||
1791|064|P|nonprescription drugs, and herbal products).||
1791|065|P|   During pregnancy, this medication should be used only when||
1791|066|P|clearly needed. Discuss the risks and benefits with your doctor.||
1791|067|P|   It is unknown if this drug passes into breast milk. Consult||
1791|068|P|your doctor before breastfeeding.||
1791|069|B|||
1791|070|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1791|071|I|medications work or increase your risk for serious side effects.||
1791|072|I|This document does not contain all possible drug interactions.||
1791|073|I|Keep a list of all the products you use (including||
1791|074|I|prescription/nonprescription drugs and herbal products) and share||
1791|075|I|it with your doctor and pharmacist. Do not start, stop, or change||
1791|076|I|the dosage of any medicines without your doctor's approval.||
1791|077|B|||
1791|078|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1791|079|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1791|080|O|poison control center right away. US residents can call||
1791|081|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1791|082|B|||
1791|083|N|NOTES:  Keep all medical and lab appointments.||
1791|084|B|||
1791|085|D|MISSED DOSE:  It is important to get each dose of this medication||
1791|086|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1791|087|D|right away for a new dosing schedule.||
1791|088|B|||
1791|089|R|STORAGE:  Not applicable. This medication is given in a clinic||
1791|090|R|and will not be stored at home.||
1791|091|B|||
1791|092|A|Information last revised February 2025.||
1791|093|A|Copyright(c) 2025 First Databank, Inc.||
1791|094|B|||
1792|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1792|002|Z|does NOT have all possible information about this product. This||
1792|003|Z|information does not assure that this product is safe, effective,||
1792|004|Z|or appropriate for you. This information is not individual||
1792|005|Z|medical advice and does not substitute for the advice of your||
1792|006|Z|health care professional. Always ask your health care||
1792|007|Z|professional for complete information about this product and your||
1792|008|Z|specific health needs.||
1792|009|B|||
1792|010|T|ASPIRIN/OMEPRAZOLE - ORAL||
1792|011|F|(AS-pir-in/oh-MEP-ra-zole)||
1792|012|B|||
1792|013|C|COMMON BRAND NAME(S): Yosprala||
1792|014|B|||
1792|015|U|USES:  This combination product contains two medications: aspirin||
1792|016|U|and omeprazole. It is used to reduce the risk of stroke or heart||
1792|017|U|attack in people who have had "mini-strokes" (transient ischemic||
1792|018|U|attacks), or a stroke due to a blood clot, or who have heart||
1792|019|U|disease. This product is used by people who are at risk for||
1792|020|U|developing ulcers while taking aspirin.||
1792|021|U|   Aspirin belongs to a class of drugs known as antiplatelets. It||
1792|022|U|has many uses, such as for pain relief or to reduce a fever. In||
1792|023|U|low doses (such as this product), it is used to prevent harmful||
1792|024|U|blood clots that can cause a stroke or heart attack. It works by||
1792|025|U|stopping platelets in your blood from clumping together to form||
1792|026|U|clots. Omeprazole belongs to a class of drugs known as proton||
1792|027|U|pump inhibitors (PPIs). It works by decreasing the amount of acid||
1792|028|U|your stomach makes. This effect helps prevent ulcers and other||
1792|029|U|stomach-related problems (such as heartburn) that can be caused||
1792|030|U|by aspirin.||
1792|031|U|   This medication contains a delayed-release form of aspirin. It||
1792|032|U|should not be used to treat conditions that require an||
1792|033|U|immediate-release form of aspirin, such as right after a heart||
1792|034|U|attack or before certain heart procedures (such as percutaneous||
1792|035|U|coronary intervention-PCI). Also, this combination product is not||
1792|036|U|the same as taking aspirin and omeprazole separately.||
1792|037|B|||
1792|038|H|HOW TO USE:  Read the Medication Guide provided by your||
1792|039|H|pharmacist before you start taking this medication and each time||
1792|040|H|you get a refill. If you have any questions, ask your doctor or||
1792|041|H|pharmacist.||
1792|042|H|   Take this medication by mouth as directed by your doctor,||
1792|043|H|usually once daily at least 60 minutes before a meal. Swallow the||
1792|044|H|tablet whole with a full glass of water (8 ounces or 240||
1792|045|H|milliliters) unless your doctor directs you otherwise. Do not lie||
1792|046|H|down for at least 10 minutes after taking this medication. Do not||
1792|047|H|split, crush, chew, or dissolve the tablet. Doing so can release||
1792|048|H|all of the drug at once, increasing the risk of side effects.||
1792|049|H|   The dosage is based on your medical condition and response to||
1792|050|H|treatment. Use this medication regularly to get the most benefit||
1792|051|H|from it. To help you remember, take it at the same time each day.||
1792|052|B|||
1792|053|S|SIDE EFFECTS:  Upset stomach or heartburn may occur. If either of||
1792|054|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1792|055|S|promptly.||
1792|056|S|   Remember that this medication has been prescribed because your||
1792|057|S|doctor has judged that the benefit to you is greater than the||
1792|058|S|risk of side effects. Many people using this medication do not||
1792|059|S|have serious side effects.||
1792|060|S|   Tell your doctor right away if you have any serious side||
1792|061|S|effects, including: easy bleeding/bruising, unusual tiredness,||
1792|062|S|signs of liver problems (such as nausea/vomiting that doesn't||
1792|063|S|stop, loss of appetite, yellowing eyes/skin, dark urine),||
1792|064|S|symptoms of a low magnesium blood level (such as muscle spasms,||
1792|065|S|irregular heartbeat, seizures), signs of lupus (such as rash on||
1792|066|S|nose and cheeks, new or worsening joint pain), signs of kidney||
1792|067|S|problems (such as change in the amount of urine, pink/bloody||
1792|068|S|urine).||
1792|069|S|   This drug may rarely cause serious (rarely fatal) bleeding||
1792|070|S|from the stomach or intestines. If you notice any of the||
1792|071|S|following unlikely but serious side effects, stop taking this||
1792|072|S|medication and consult your doctor or pharmacist right away:||
1792|073|S|stomach/abdominal pain that doesn't go away, black stools, vomit||
1792|074|S|that looks like coffee grounds.||
1792|075|S|   This medication may rarely cause a severe intestinal condition||
1792|076|S|due to a bacteria called C. difficile. This condition may occur||
1792|077|S|during treatment or weeks to months after treatment has stopped.||
1792|078|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1792|079|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1792|080|S|stool.||
1792|081|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1792|082|S|products because they may make symptoms worse.||
1792|083|S|   Rarely, proton pump inhibitors (such as omeprazole) have||
1792|084|S|caused vitamin B-12 deficiency. The risk is increased if they are||
1792|085|S|taken every day for a long time (3 years or longer). Tell your||
1792|086|S|doctor right away if you develop symptoms of vitamin B-12||
1792|087|S|deficiency (such as unusual weakness, sore tongue, or||
1792|088|S|numbness/tingling of the hands/feet).||
1792|089|S|   A very serious allergic reaction to this drug is rare.||
1792|090|S|However, get medical help right away if you notice any symptoms||
1792|091|S|of a serious allergic reaction, including: fever, swollen lymph||
1792|092|S|nodes, rash, itching/swelling (especially of the||
1792|093|S|face/tongue/throat), severe dizziness, trouble breathing.||
1792|094|S|   This is not a complete list of possible side effects. If you||
1792|095|S|notice other effects not listed above, contact your doctor or||
1792|096|S|pharmacist.||
1792|097|S|   In the US -||
1792|098|S|   Call your doctor for medical advice about side effects. You||
1792|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1792|100|S|www.fda.gov/medwatch.||
1792|101|S|   In Canada - Call your doctor for medical advice about side||
1792|102|S|effects. You may report side effects to Health Canada at||
1792|103|S|1-866-234-2345.||
1792|104|B|||
1792|105|P|PRECAUTIONS:  Before taking this medication, tell your doctor if||
1792|106|P|you are allergic to aspirin or omeprazole; or to other||
1792|107|P|salicylates (such as choline salicylate); or to NSAIDs (such as||
1792|108|P|ibuprofen, naproxen); or to other PPIs (such as esomeprazole,||
1792|109|P|lansoprazole); or if you have any other allergies. This product||
1792|110|P|may contain inactive ingredients, which can cause allergic||
1792|111|P|reactions or other problems. Talk to your pharmacist for more||
1792|112|P|details.||
1792|113|P|   Before using this medication, tell your doctor or pharmacist||
1792|114|P|your medical history, especially of: asthma (including a history||
1792|115|P|of worsening breathing after taking aspirin or other NSAIDs),||
1792|116|P|bleeding/blood problems (such as hemophilia, vitamin K||
1792|117|P|deficiency), stomach/intestinal/esophagus problems (such as||
1792|118|P|bleeding, heartburn, ulcers), kidney disease, liver disease,||
1792|119|P|growths in the nose (nasal polyps), lupus.||
1792|120|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1792|121|P|and tobacco while using this medicine may increase your risk for||
1792|122|P|stomach bleeding. Limit alcohol and stop smoking. Ask your doctor||
1792|123|P|or pharmacist about how much alcohol you may safely drink.||
1792|124|P|   Before having surgery, tell your doctor or dentist about all||
1792|125|P|the products you use (including prescription drugs,||
1792|126|P|nonprescription drugs, and herbal products). Your doctor may||
1792|127|P|instruct you to stop this medication before surgery. Do not stop||
1792|128|P|taking it without first talking with your doctor.||
1792|129|P|   Proton pump inhibitors (such as omeprazole) may increase your||
1792|130|P|risk for bone fractures, especially with longer use, higher||
1792|131|P|doses, and in older adults. Talk with your doctor or pharmacist||
1792|132|P|about ways to prevent bone loss/fracture, such as by taking||
1792|133|P|calcium (such as calcium citrate) and vitamin D supplements.||
1792|134|P|   Older adults may be more sensitive to the side effects of this||
1792|135|P|drug, especially bone loss and fractures (see above), bleeding,||
1792|136|P|and C. difficile infection (see Side Effects section).||
1792|137|P|   This drug contains aspirin. Children and teenagers younger||
1792|138|P|than 18 years should not take aspirin if they have chickenpox,||
1792|139|P|flu, or any undiagnosed illness or if they have recently received||
1792|140|P|a vaccine. In these cases, taking aspirin increases the risk of||
1792|141|P|Reye's syndrome, a rare but serious illness.||
1792|142|P|   Aspirin is not recommended for use to treat pain or fever||
1792|143|P|during pregnancy. Before using this medication, women of||
1792|144|P|childbearing age should talk with their doctor(s) about the||
1792|145|P|benefits and risks. Tell your doctor if you are pregnant or if||
1792|146|P|you plan to become pregnant. This medication may harm an unborn||
1792|147|P|baby and cause problems with normal labor/delivery. It is not||
1792|148|P|recommended for use in pregnancy from 20 weeks until delivery. If||
1792|149|P|your doctor decides that you need to use this medication between||
1792|150|P|20 and 30 weeks of pregnancy, you should use the lowest effective||
1792|151|P|dose for the shortest possible time. In some cases, low-dose||
1792|152|P|aspirin (usually 81-162 milligrams a day) may be used safely||
1792|153|P|during pregnancy to prevent certain conditions. Talk to your||
1792|154|P|doctor for more details.||
1792|155|P|   Aspirin passes into breast milk. When used in large amounts||
1792|156|P|(such as to treat pain or fever), it may harm a nursing infant||
1792|157|P|and breastfeeding is not recommended while using this medication.||
1792|158|P|However, low-dose aspirin for heart attack or stroke prevention||
1792|159|P|may be used if directed by your doctor. Consult your doctor||
1792|160|P|before breastfeeding.||
1792|161|B|||
1792|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1792|163|I|medications work or increase your risk for serious side effects.||
1792|164|I|This document does not contain all possible drug interactions.||
1792|165|I|Keep a list of all the products you use (including||
1792|166|I|prescription/nonprescription drugs and herbal products) and share||
1792|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
1792|168|I|the dosage of any medicines without your doctor's approval.||
1792|169|I|   Some products that may interact with this drug include:||
1792|170|I|corticosteroids (such as prednisone), methotrexate (especially||
1792|171|I|high-dose treatment), mifepristone, ginkgo biloba, other drugs||
1792|172|I|that can cause bleeding/bruising (including antiplatelet drugs||
1792|173|I|such as clopidogrel, ticagrelor, NSAIDs such as||
1792|174|I|ibuprofen/naproxen, "blood thinners" such as||
1792|175|I|warfarin/dabigatran).||
1792|176|I|   Check all prescription and nonprescription medicine labels||
1792|177|I|carefully since many medications contain pain relievers/fever||
1792|178|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
1792|179|I|naproxen). These drugs are similar to this medication and may||
1792|180|I|increase your risk of side effects if taken together. Ask your||
1792|181|I|doctor or pharmacist for more details.||
1792|182|I|   Some products need stomach acid so that the body can absorb||
1792|183|I|them properly. Omeprazole decreases stomach acid, so it may||
1792|184|I|change how well these products work. Some affected products||
1792|185|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
1792|186|I|pazopanib, rilpivirine, sparsentan, certain azole antifungals||
1792|187|I|(itraconazole, ketoconazole, posaconazole), among others.||
1792|188|I|   Other medications can affect the removal of omeprazole from||
1792|189|I|your body, which may affect how this product works. Examples||
1792|190|I|include rifampin, St John's wort, among others.||
1792|191|I|   Omeprazole is very similar to esomeprazole. Do not use any||
1792|192|I|medications containing esomeprazole while using omeprazole.||
1792|193|I|   This medication may interfere with certain lab or medical||
1792|194|I|tests, possibly causing false test results. Make sure lab||
1792|195|I|personnel and all your doctors know you use this drug.||
1792|196|B|||
1792|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1792|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1792|199|O|poison control center right away. US residents can call||
1792|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1792|201|O|Symptoms of overdose may include: ringing in the ears, flushing,||
1792|202|O|sweating, restlessness, weakness, dizziness, fast heartbeat.||
1792|203|B|||
1792|204|N|NOTES:  Do not share this medication with others.||
1792|205|N|   Lab tests (such as magnesium blood test, vitamin B-12 levels)||
1792|206|N|may be done while you are taking this medication. Keep all||
1792|207|N|medical and lab appointments.||
1792|208|B|||
1792|209|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1792|210|D|remember. If it is near the time of the next dose, skip the||
1792|211|D|missed dose. Take your next dose at the regular time. Do not||
1792|212|D|double the dose to catch up.||
1792|213|B|||
1792|214|R|STORAGE:  Store at room temperature away from light and moisture.||
1792|215|R|Do not store in the bathroom. Keep all medications away from||
1792|216|R|children and pets.||
1792|217|R|   Do not flush medications down the toilet or pour them into a||
1792|218|R|drain unless instructed to do so. Properly discard this product||
1792|219|R|when it is expired or no longer needed. Consult your pharmacist||
1792|220|R|or local waste disposal company.||
1792|221|B|||
1792|222|A|Information last revised November 2025.||
1792|223|A|Copyright(c) 2025 First Databank, Inc.||
1792|224|B|||
1793|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1793|002|Z|does NOT have all possible information about this product. This||
1793|003|Z|information does not assure that this product is safe, effective,||
1793|004|Z|or appropriate for you. This information is not individual||
1793|005|Z|medical advice and does not substitute for the advice of your||
1793|006|Z|health care professional. Always ask your health care||
1793|007|Z|professional for complete information about this product and your||
1793|008|Z|specific health needs.||
1793|009|B|||
1793|010|T|CANAGLIFLOZIN/METFORMIN EXTENDED-RELEASE - ORAL||
1793|011|F|(KAN-a-gli-FLOE-zin/met-FOR-min)||
1793|012|B|||
1793|013|C|COMMON BRAND NAME(S): Invokamet XR||
1793|014|B|||
1793|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1793|016|W|cause a serious (sometimes fatal) condition called lactic||
1793|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1793|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1793|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1793|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1793|021|W|you are using certain drugs. For some conditions, your doctor may||
1793|022|W|tell you to stop taking this medication for a short time. Ask||
1793|023|W|your doctor or pharmacist for more details.||
1793|024|W|   Stop taking this medication and get medical help right away if||
1793|025|W|you have any symptoms of lactic acidosis, such as unusual||
1793|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1793|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1793|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1793|029|B|||
1793|030|U|USES:  This medication is a combination of 2 drugs: canagliflozin||
1793|031|U|and metformin. It is used with a proper diet and exercise program||
1793|032|U|to control high blood sugar in people with type 2 diabetes.||
1793|033|U|Controlling high blood sugar helps prevent kidney damage,||
1793|034|U|blindness, nerve problems, loss of limbs, and sexual function||
1793|035|U|problems. Proper control of diabetes may also lessen your risk of||
1793|036|U|a heart attack or stroke. This medication works by helping to||
1793|037|U|restore your body's proper response to the insulin you naturally||
1793|038|U|produce. It also increases the removal of sugar by your kidneys,||
1793|039|U|decreases how much sugar is made in your liver, and decreases how||
1793|040|U|much sugar your body takes in through your stomach and||
1793|041|U|intestines.||
1793|042|B|||
1793|043|H|HOW TO USE:  Read the Medication Guide provided by your||
1793|044|H|pharmacist before you start taking this medication and each time||
1793|045|H|you get a refill. If you have any questions, ask your doctor or||
1793|046|H|pharmacist.||
1793|047|H|   Take this medication by mouth as directed by your doctor,||
1793|048|H|usually once daily with the morning meal. Swallow the tablets||
1793|049|H|whole. Do not crush or chew the tablets. Doing so can release all||
1793|050|H|of the drug at once, increasing the risk of side effects. Take||
1793|051|H|this medication regularly to get the most benefit from it. To||
1793|052|H|help you remember, take it at the same time each day. Drink||
1793|053|H|plenty of fluids while taking this medication unless otherwise||
1793|054|H|directed by your doctor.||
1793|055|H|   The dosage is based on your medical condition, response to||
1793|056|H|treatment, and other medications you may be taking. Be sure to||
1793|057|H|tell your doctor and pharmacist about all the products you use||
1793|058|H|(including prescription drugs, nonprescription drugs, and herbal||
1793|059|H|products). To reduce your risk of side effects (such as upset||
1793|060|H|stomach), your doctor may direct you to start this medication at||
1793|061|H|a low dose and gradually increase your dose. Follow your doctor's||
1793|062|H|instructions carefully.||
1793|063|H|   Tell your doctor if your condition does not get better or if||
1793|064|H|it gets worse (your blood sugar is too high or too low).||
1793|065|B|||
1793|066|S|SIDE EFFECTS:  See also Warning section.||
1793|067|S|   Nausea, vomiting, stomach upset, diarrhea, bloating/gas,||
1793|068|S|frequent urination, unusual dry mouth, or weakness may occur. If||
1793|069|S|any of these effects last or get worse, tell your doctor or||
1793|070|S|pharmacist promptly. If stomach symptoms return later (after||
1793|071|S|taking the same dose for several days or weeks), tell your doctor||
1793|072|S|right away. Stomach symptoms that occur after the first days of||
1793|073|S|your treatment may be signs of lactic acidosis.||
1793|074|S|   An empty tablet shell may appear in your stool. This effect is||
1793|075|S|harmless because your body has already absorbed the medication.||
1793|076|S|   Remember that this medication has been prescribed because your||
1793|077|S|doctor has judged that the benefit to you is greater than the||
1793|078|S|risk of side effects. Many people using this medication do not||
1793|079|S|have serious side effects.||
1793|080|S|   Tell your doctor right away if you have any serious side||
1793|081|S|effects, including: signs of a urinary tract infection (such as||
1793|082|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1793|083|S|signs of kidney problems (such as change in the amount of urine,||
1793|084|S|swelling legs/feet), signs of high level of potassium in the||
1793|085|S|blood (such as muscle weakness and slow/irregular heartbeat).||
1793|086|S|   This medication may cause a new yeast infection in the vagina||
1793|087|S|or the penis. It may also cause a rare but very serious bacterial||
1793|088|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1793|089|S|your doctor right away if you have signs of a yeast infection in||
1793|090|S|the vagina (such as unusual vaginal||
1793|091|S|discharge/burning/itching/odor) or in the penis (such as||
1793|092|S|redness/itching/swelling of the penis, unusual discharge from the||
1793|093|S|penis). However, get medical help right away if you have any||
1793|094|S|pain/redness/swelling in or around the genital/anal area, along||
1793|095|S|with a fever or feeling unwell.||
1793|096|S|   This medication does not usually cause low blood sugar||
1793|097|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1793|098|S|prescribed with other diabetes medications, or if you do not get||
1793|099|S|enough calories from food, or if you do unusually heavy exercise.||
1793|100|S|Talk with your doctor or pharmacist about whether the dose of||
1793|101|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1793|102|S|of low blood sugar include sudden sweating, shaking, fast||
1793|103|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1793|104|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1793|105|S|treat low blood sugar. If you don't have these reliable forms of||
1793|106|S|glucose, rapidly raise your blood sugar by eating a quick source||
1793|107|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1793|108|S|juice or non-diet soda. Tell your doctor right away about the||
1793|109|S|reaction and the use of this product. To help prevent low blood||
1793|110|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1793|111|S|Check with your doctor or pharmacist to find out what you should||
1793|112|S|do if you miss a meal.||
1793|113|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1793|114|S|thirst/urination. If these symptoms occur, tell your doctor right||
1793|115|S|away. Your doctor may need to adjust your diabetes medication,||
1793|116|S|exercise program, or diet.||
1793|117|S|   Canagliflozin may rarely increase the risk of losing a lower||
1793|118|S|limb. This risk may be greater in people who have a history of||
1793|119|S|heart disease, blood circulation disease (peripheral vascular||
1793|120|S|disease), nerve problems (neuropathy), foot ulcers, or previous||
1793|121|S|loss of limbs. Talk to your doctor for more details. Tell your||
1793|122|S|doctor right away if you have any||
1793|123|S|pain/tenderness/redness/swelling/sores on your legs and feet.||
1793|124|S|   This medication may cause you to become dehydrated. This can||
1793|125|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1793|126|S|dehydration. Tell your doctor or pharmacist right away if you are||
1793|127|S|not able to drink fluids as usual, or losing fluid (such as due||
1793|128|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1793|129|S|right away if you have any signs of dehydration, such as||
1793|130|S|urinating less than usual, unusual dry mouth/thirst, fast||
1793|131|S|heartbeat, or dizziness/lightheadedness/fainting. To reduce the||
1793|132|S|risk of dizziness and lightheadedness, get up slowly when rising||
1793|133|S|from a sitting or lying position.||
1793|134|S|   Canagliflozin may cause bone loss (osteoporosis), or even a||
1793|135|S|broken bone. Lifestyle changes that help promote healthy bones||
1793|136|S|include increasing weight-bearing exercise, stopping smoking,||
1793|137|S|limiting alcohol, and eating well-balanced meals that contain||
1793|138|S|adequate calcium and vitamin D. You may also need to take calcium||
1793|139|S|and vitamin D supplements. Consult your doctor for specific||
1793|140|S|advice.||
1793|141|S|   A very serious allergic reaction to this drug is rare.||
1793|142|S|However, get medical help right away if you notice any symptoms||
1793|143|S|of a serious allergic reaction, including: rash, itching/swelling||
1793|144|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1793|145|S|breathing.||
1793|146|S|   This is not a complete list of possible side effects. If you||
1793|147|S|notice other effects not listed above, contact your doctor or||
1793|148|S|pharmacist.||
1793|149|S|   In the US -||
1793|150|S|   Call your doctor for medical advice about side effects. You||
1793|151|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1793|152|S|www.fda.gov/medwatch.||
1793|153|S|   In Canada - Call your doctor for medical advice about side||
1793|154|S|effects. You may report side effects to Health Canada at||
1793|155|S|1-866-234-2345.||
1793|156|B|||
1793|157|P|PRECAUTIONS:  See also Warning and Side Effects sections.||
1793|158|P|   Before taking this medication, tell your doctor or pharmacist||
1793|159|P|if you are allergic to canagliflozin or metformin; or if you have||
1793|160|P|any other allergies. This product may contain inactive||
1793|161|P|ingredients, which can cause allergic reactions or other||
1793|162|P|problems. Talk to your pharmacist for more details.||
1793|163|P|   Before using this medication, tell your doctor or pharmacist||
1793|164|P|your medical history, especially of: breathing problems (such as||
1793|165|P|asthma, obstructive lung disease), blood problems (such as||
1793|166|P|anemia, vitamin B12 deficiency), dehydration, low blood pressure,||
1793|167|P|heart failure, kidney disease, liver problems, disease of the||
1793|168|P|pancreas (pancreatitis), use/abuse of alcohol, blood mineral||
1793|169|P|imbalances (such as high levels of potassium), yeast infections||
1793|170|P|in the vagina or penis.||
1793|171|P|   Before having surgery or any X-ray/scanning procedure using||
1793|172|P|iodinated contrast, tell your doctor or dentist about all the||
1793|173|P|products you use (including prescription drugs, nonprescription||
1793|174|P|drugs, and herbal products). You may need to stop this medication||
1793|175|P|for a short time for the surgery/procedure. Ask your doctor or||
1793|176|P|dentist for instructions before your surgery/procedure.||
1793|177|P|   You may experience blurred vision, dizziness, or drowsiness||
1793|178|P|due to extremely low or high blood sugar. Do not drive, use||
1793|179|P|machinery, or do anything that needs alertness or clear vision||
1793|180|P|until you can do it safely.||
1793|181|P|   Limit alcohol while using this medication because it can||
1793|182|P|increase your risk of developing lactic acidosis, low blood||
1793|183|P|sugar, or a high ketone level.||
1793|184|P|   High fever, "water pills" (diuretics such as||
1793|185|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1793|186|P|may cause dehydration and increase your risk of lactic acidosis.||
1793|187|P|Stop taking this medication and tell your doctor right away if||
1793|188|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1793|189|P|fluids to prevent dehydration unless your doctor directs you||
1793|190|P|otherwise.||
1793|191|P|   It may be harder to control your blood sugar when your body is||
1793|192|P|stressed (such as due to fever, infection, injury, or surgery).||
1793|193|P|Also, if you are eating less or not able to eat due to these||
1793|194|P|conditions or any illness, this can lead to a high ketone level||
1793|195|P|while you are taking this medication. Consult your doctor because||
1793|196|P|this may require a change in your treatment plan, medications, or||
1793|197|P|blood sugar or ketone testing.||
1793|198|P|   Older adults may be at greater risk for side effects such as||
1793|199|P|low blood sugar, dehydration, lactic acidosis, dizziness/fainting||
1793|200|P|(usually when standing), or bone loss while using this drug.||
1793|201|P|   Metformin can cause changes in the menstrual cycle (promote||
1793|202|P|ovulation) and increase the risk of becoming pregnant. Consult||
1793|203|P|your doctor or pharmacist about the use of reliable birth control||
1793|204|P|while using this medication.||
1793|205|P|   During pregnancy, this medication should be used only when||
1793|206|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1793|207|P|benefits with your doctor.||
1793|208|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1793|209|P|your doctor for managing your blood sugar while pregnant. Your||
1793|210|P|doctor may change your diabetes treatment during your pregnancy||
1793|211|P|(such as diet and medications including insulin).||
1793|212|P|   Metformin passes into breast milk in small amounts. It is||
1793|213|P|unknown if canagliflozin passes into breast milk. Consult your||
1793|214|P|doctor before breastfeeding.||
1793|215|B|||
1793|216|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1793|217|I|medications work or increase your risk for serious side effects.||
1793|218|I|This document does not contain all possible drug interactions.||
1793|219|I|Keep a list of all the products you use (including||
1793|220|I|prescription/nonprescription drugs and herbal products) and share||
1793|221|I|it with your doctor and pharmacist. Do not start, stop, or change||
1793|222|I|the dosage of any medicines without your doctor's approval.||
1793|223|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1793|224|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1793|225|I|heartbeat you would usually feel when your blood sugar falls too||
1793|226|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1793|227|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1793|228|I|   Many drugs can affect your blood sugar levels, making it more||
1793|229|I|difficult to control your blood sugar. Before you start, stop, or||
1793|230|I|change any medication, talk with your doctor or pharmacist about||
1793|231|I|how the medication may affect your blood sugar. Check your blood||
1793|232|I|sugar regularly as directed by your doctor. Tell your doctor||
1793|233|I|about the results and of any symptoms of high or low blood sugar.||
1793|234|I|(See also Side Effects section.) Your doctor may need to adjust||
1793|235|I|your diabetes medication, exercise program, or diet.||
1793|236|I|   Your urine will test positive for glucose. Make sure lab||
1793|237|I|personnel and all your doctors know you use this drug.||
1793|238|B|||
1793|239|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1793|240|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1793|241|O|poison control center right away. US residents can call||
1793|242|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1793|243|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
1793|244|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
1793|245|O|rapid breathing, slow/irregular heartbeat.||
1793|246|B|||
1793|247|N|NOTES:  Do not share this medication with others.||
1793|248|N|   Attend a diabetes education program to learn more about how to||
1793|249|N|manage your diabetes with medications, diet, exercise, and||
1793|250|N|regular medical exams.||
1793|251|N|   Learn the symptoms of high and low blood sugar and how to||
1793|252|N|treat low blood sugar. Check your blood sugar regularly as||
1793|253|N|directed.||
1793|254|N|   Lab and/or medical tests (such as kidney/liver function,||
1793|255|N|fasting blood sugar, hemoglobin A1c, ketones, complete blood||
1793|256|N|counts, blood pressure, cholesterol, bone density, mineral levels||
1793|257|N|including potassium) should be done before you start taking this||
1793|258|N|medication and while you are taking it. Keep all medical and lab||
1793|259|N|appointments. Consult your doctor for more details.||
1793|260|B|||
1793|261|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1793|262|D|remember. If it is near the time of the next dose, skip the||
1793|263|D|missed dose. Take your next dose at the regular time. Do not||
1793|264|D|double the dose to catch up.||
1793|265|B|||
1793|266|R|STORAGE:  Store in the original bottle at room temperature away||
1793|267|R|from light and moisture. Do not store in the bathroom. If the||
1793|268|R|medication is kept in a pill box or medication reminder box, the||
1793|269|R|medication expires after 30 days. Keep all medications away from||
1793|270|R|children and pets.||
1793|271|R|   Do not flush medications down the toilet or pour them into a||
1793|272|R|drain unless instructed to do so. Properly discard this product||
1793|273|R|when it is expired or no longer needed. Consult your pharmacist||
1793|274|R|or local waste disposal company.||
1793|275|B|||
1793|276|M|MEDICAL ALERT:  Your condition can cause complications in a||
1793|277|M|medical emergency. For information about enrolling in MedicAlert,||
1793|278|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1793|279|B|||
1793|280|A|Information last revised May 2025.||
1793|281|A|Copyright(c) 2025 First Databank, Inc.||
1793|282|B|||
1794|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1794|002|Z|does NOT have all possible information about this product. This||
1794|003|Z|information does not assure that this product is safe, effective,||
1794|004|Z|or appropriate for you. This information is not individual||
1794|005|Z|medical advice and does not substitute for the advice of your||
1794|006|Z|health care professional. Always ask your health care||
1794|007|Z|professional for complete information about this product and your||
1794|008|Z|specific health needs.||
1794|009|B|||
1794|010|T|GRANISETRON - SUBCUTANEOUS INJECTION||
1794|011|F|(gra-NIS-e-tron)||
1794|012|B|||
1794|013|C|COMMON BRAND NAME(S): Sustol||
1794|014|B|||
1794|015|U|USES:  Granisetron is used to help prevent nausea and vomiting||
1794|016|U|caused by cancer chemotherapy. It works by blocking the effect of||
1794|017|U|a natural substance in your body (serotonin) that may cause||
1794|018|U|nausea or vomiting.||
1794|019|B|||
1794|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1794|021|H|pharmacist before you start using granisetron and each time you||
1794|022|H|get a refill. If you have any questions, ask your doctor or||
1794|023|H|pharmacist.||
1794|024|H|   This medication is given as directed by your doctor, usually||
1794|025|H|30 minutes before chemotherapy on day 1 of your treatment cycle.||
1794|026|H|It is given by slow injection under the skin on the back of your||
1794|027|H|upper arm or the skin on your abdomen by a health care||
1794|028|H|professional.||
1794|029|H|   The dosage is based on your medical condition and response to||
1794|030|H|treatment. This medication is a long-acting form of granisetron||
1794|031|H|so you should not receive it more often than once every 7 days.||
1794|032|H|   Tell your doctor if your nausea or vomiting does not get||
1794|033|H|better or if it gets worse.||
1794|034|B|||
1794|035|S|SIDE EFFECTS:  Pain, soreness, redness, bleeding, lumps, or||
1794|036|S|swelling at the injection site may occur. Bruising is common, but||
1794|037|S|may not happen until a few days after receiving the injection.||
1794|038|S|Constipation, tiredness, headache, diarrhea, or dizziness may||
1794|039|S|also occur. If any of these effects last or get worse, tell your||
1794|040|S|doctor promptly.||
1794|041|S|   Remember that this medication has been prescribed because your||
1794|042|S|doctor has judged that the benefit to you is greater than the||
1794|043|S|risk of side effects. Many people using this medication do not||
1794|044|S|have serious side effects.||
1794|045|S|   Tell your doctor right away if you have any serious side||
1794|046|S|effects, including: stomach/abdominal pain.||
1794|047|S|   Get medical help right away if you have any very serious side||
1794|048|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1794|049|S|dizziness, fainting.||
1794|050|S|   This medication may increase serotonin and rarely cause a very||
1794|051|S|serious condition called serotonin syndrome/toxicity. The risk||
1794|052|S|increases if you are also taking other drugs that increase||
1794|053|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1794|054|S|take (see Drug Interactions section). Get medical help right away||
1794|055|S|if you develop some of the following symptoms: fast heartbeat,||
1794|056|S|hallucinations, loss of coordination, severe dizziness, severe||
1794|057|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1794|058|S|unusual agitation/restlessness.||
1794|059|S|   A very serious allergic reaction to this drug is rare.||
1794|060|S|However, get medical help right away if you notice any symptoms||
1794|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1794|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1794|063|S|breathing.||
1794|064|S|   This is not a complete list of possible side effects. If you||
1794|065|S|notice other effects not listed above, contact your doctor or||
1794|066|S|pharmacist.||
1794|067|S|   In the US -||
1794|068|S|   Call your doctor for medical advice about side effects. You||
1794|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1794|070|S|www.fda.gov/medwatch.||
1794|071|S|   In Canada - Call your doctor for medical advice about side||
1794|072|S|effects. You may report side effects to Health Canada at||
1794|073|S|1-866-234-2345.||
1794|074|B|||
1794|075|P|PRECAUTIONS:  Before using granisetron, tell your doctor or||
1794|076|P|pharmacist if you are allergic to it; or to other anti-nausea||
1794|077|P|serotonin blockers (such as dolasetron, ondansetron); or if you||
1794|078|P|have any other allergies. This product may contain inactive||
1794|079|P|ingredients, which can cause allergic reactions or other||
1794|080|P|problems. Talk to your pharmacist for more details.||
1794|081|P|   Before using this medication, tell your doctor or pharmacist||
1794|082|P|your medical history, especially of: kidney problems,||
1794|083|P|stomach/intestinal problems (such as recent surgery, ileus,||
1794|084|P|swelling).||
1794|085|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1794|086|P|can make you more dizzy. Do not drive, use machinery, or do||
1794|087|P|anything that needs alertness until you can do it safely. Limit||
1794|088|P|alcoholic beverages. Talk to your doctor if you are using||
1794|089|P|marijuana (cannabis).||
1794|090|P|   Granisetron may cause a condition that affects the heart||
1794|091|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1794|092|P|serious (rarely fatal) fast/irregular heartbeat and other||
1794|093|P|symptoms (such as severe dizziness, fainting) that need medical||
1794|094|P|attention right away.||
1794|095|P|   The risk of QT prolongation may be increased if you have||
1794|096|P|certain medical conditions or are taking other drugs that may||
1794|097|P|cause QT prolongation. Before using granisetron, tell your doctor||
1794|098|P|or pharmacist of all the drugs you take and if you have any of||
1794|099|P|the following conditions: certain heart problems (heart failure,||
1794|100|P|slow heartbeat, QT prolongation in the EKG), family history of||
1794|101|P|certain heart problems (QT prolongation in the EKG, sudden||
1794|102|P|cardiac death).||
1794|103|P|   Low levels of potassium or magnesium in the blood may also||
1794|104|P|increase your risk of QT prolongation. This risk may increase if||
1794|105|P|you use certain drugs (such as diuretics/"water pills") or if you||
1794|106|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1794|107|P|Talk to your doctor about using granisetron safely.||
1794|108|P|   Before having surgery, tell your doctor or dentist about all||
1794|109|P|the products you use (including prescription drugs,||
1794|110|P|nonprescription drugs, and herbal products).||
1794|111|P|   Older adults may be more sensitive to the side effects of this||
1794|112|P|drug, especially QT prolongation (see above).||
1794|113|P|   During pregnancy, this medication should be used only when||
1794|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
1794|115|P|   It is unknown if this drug passes into breast milk. Consult||
1794|116|P|your doctor before breastfeeding.||
1794|117|B|||
1794|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1794|119|I|medications work or increase your risk for serious side effects.||
1794|120|I|This document does not contain all possible drug interactions.||
1794|121|I|Keep a list of all the products you use (including||
1794|122|I|prescription/nonprescription drugs and herbal products) and share||
1794|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
1794|124|I|the dosage of any medicines without your doctor's approval.||
1794|125|I|   A product that may interact with this drug is: apomorphine.||
1794|126|I|   The risk of serotonin syndrome/toxicity increases if you are||
1794|127|I|also taking other drugs that increase serotonin. Examples include||
1794|128|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1794|129|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1794|130|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1794|131|I|serotonin syndrome/toxicity may be more likely when you start or||
1794|132|I|increase the dose of these drugs.||
1794|133|B|||
1794|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1794|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1794|136|O|poison control center right away. US residents can call||
1794|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1794|138|B|||
1794|139|N|NOTES:  Do not share this medication with others.||
1794|140|B|||
1794|141|D|MISSED DOSE:  It is important to get each dose of this medication||
1794|142|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1794|143|D|right away for a new dosing schedule.||
1794|144|B|||
1794|145|R|STORAGE:  Not applicable. This medication is given in a hospital||
1794|146|R|or clinic or doctor's office and will not be stored at home.||
1794|147|B|||
1794|148|A|Information last revised May 2024.||
1794|149|A|Copyright(c) 2025 First Databank, Inc.||
1794|150|B|||
1795|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1795|002|Z|does NOT have all possible information about this product. This||
1795|003|Z|information does not assure that this product is safe, effective,||
1795|004|Z|or appropriate for you. This information is not individual||
1795|005|Z|medical advice and does not substitute for the advice of your||
1795|006|Z|health care professional. Always ask your health care||
1795|007|Z|professional for complete information about this product and your||
1795|008|Z|specific health needs.||
1795|009|B|||
1795|010|T|IBUPROFEN EXTENDED-RELEASE - ORAL||
1795|011|F|(EYE-bue-PROE-fen)||
1795|012|B|||
1795|013|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
1795|014|W|ibuprofen) may rarely increase the risk for a heart attack or||
1795|015|W|stroke. This effect can happen at any time while taking this drug||
1795|016|W|but is more likely if you take it for a long time. The risk may||
1795|017|W|be greater in older adults or if you have heart disease or||
1795|018|W|increased risk for heart disease (for example, due to smoking,||
1795|019|W|family history of heart disease, or conditions such as high blood||
1795|020|W|pressure or diabetes). Do not take this drug right before or||
1795|021|W|after heart bypass surgery (CABG).||
1795|022|W|   Also, this drug may rarely cause serious (rarely fatal)||
1795|023|W|bleeding from the stomach or intestines. This effect can occur||
1795|024|W|without warning at any time while taking this drug. Older adults||
1795|025|W|may be at higher risk for this effect.||
1795|026|W|   Stop taking ibuprofen and get medical help right away if you||
1795|027|W|notice any of these rare but serious side effects:||
1795|028|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
1795|029|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
1795|030|W|shortness of breath, unusual sweating, confusion, weakness on one||
1795|031|W|side of the body, trouble speaking, sudden vision changes.||
1795|032|W|   Talk to your doctor or pharmacist about the benefits and risks||
1795|033|W|of taking this drug.||
1795|034|B|||
1795|035|U|USES:  See also Warning section.||
1795|036|U|   Ibuprofen is used to relieve pain from various conditions such||
1795|037|U|as headache, dental pain, menstrual cramps, muscle aches, or||
1795|038|U|arthritis. It is also used to reduce fever and to relieve minor||
1795|039|U|aches and pain due to the common cold or flu. Ibuprofen is known||
1795|040|U|as a nonsteroidal anti-inflammatory drug (NSAID). It works by||
1795|041|U|blocking your body's production of certain natural substances||
1795|042|U|that cause inflammation. This effect helps to decrease swelling,||
1795|043|U|pain, or fever.||
1795|044|U|   If you are treating a chronic condition such as arthritis, ask||
1795|045|U|your doctor about non-drug treatments and/or using other||
1795|046|U|medications to treat your pain.||
1795|047|U|   Check the ingredients on the label even if you have used the||
1795|048|U|product before. The manufacturer may have changed the||
1795|049|U|ingredients. Also, products with similar names may contain||
1795|050|U|different ingredients meant for different purposes. Taking the||
1795|051|U|wrong product could harm you.||
1795|052|B|||
1795|053|V|OTHER USES:  This section contains uses of this drug that are not||
1795|054|V|listed in the approved professional labeling for the drug but||
1795|055|V|that may be prescribed by your health care professional. Use this||
1795|056|V|drug for a condition that is listed in this section only if it||
1795|057|V|has been so prescribed by your health care professional.||
1795|058|V|   This drug may also be used for gout attacks.||
1795|059|B|||
1795|060|H|HOW TO USE:  Follow all directions on the product package. If you||
1795|061|H|have any questions, ask your doctor or pharmacist.||
1795|062|H|   Take this medication by mouth, usually every 12 hours. Swallow||
1795|063|H|the tablet whole with a full glass of water (8 ounces/240||
1795|064|H|milliliters) unless your doctor directs you otherwise. Do not lie||
1795|065|H|down for at least 10 minutes after taking this drug. If stomach||
1795|066|H|upset occurs while taking this medication, take it with food,||
1795|067|H|milk, or an antacid. Do not split, crush, chew, or dissolve the||
1795|068|H|tablet. Doing so can release all of the drug at once, increasing||
1795|069|H|the risk of side effects.||
1795|070|H|   The dosage is based on your medical condition and response to||
1795|071|H|treatment. To reduce your risk of stomach bleeding and other side||
1795|072|H|effects, take this medication at the lowest effective dose for||
1795|073|H|the shortest possible time. Do not increase your dose or take||
1795|074|H|this drug more often than directed.||
1795|075|H|   If you are taking this drug "as needed" (not on a regular||
1795|076|H|schedule), remember that pain medications work best if they are||
1795|077|H|used as the first signs of pain occur. If you wait until the pain||
1795|078|H|has worsened, the medication may not work as well.||
1795|079|H|   If your condition lasts or gets worse, or if you think you may||
1795|080|H|have a serious medical problem, get medical help right away. For||
1795|081|H|certain conditions (such as arthritis), it may take up to two||
1795|082|H|weeks of taking this drug regularly until you get the full||
1795|083|H|benefit. If you are using this product to treat fever or pain,||
1795|084|H|consult the doctor right away if fever gets worse or lasts more||
1795|085|H|than 3 days, or if pain gets worse or lasts more than 5 days.||
1795|086|B|||
1795|087|S|SIDE EFFECTS:  See also Warning section.||
1795|088|S|   Upset stomach, nausea, vomiting, headache, diarrhea,||
1795|089|S|constipation, dizziness, or drowsiness may occur. If any of these||
1795|090|S|effects last or get worse, tell your doctor or pharmacist||
1795|091|S|promptly.||
1795|092|S|   If your doctor has directed you to use this medication,||
1795|093|S|remember that your doctor has judged that the benefit to you is||
1795|094|S|greater than the risk of side effects. Many people using this||
1795|095|S|medication do not have serious side effects.||
1795|096|S|   This medication may raise your blood pressure. Check your||
1795|097|S|blood pressure regularly and tell your doctor if the results are||
1795|098|S|high.||
1795|099|S|   Tell your doctor right away if you have any serious side||
1795|100|S|effects, including: hearing changes (such as ringing in the||
1795|101|S|ears), mental/mood changes, easy bruising/bleeding,||
1795|102|S|difficult/painful swallowing, unexplained stiff neck, signs of||
1795|103|S|kidney problems (such as change in the amount of urine), symptoms||
1795|104|S|of heart failure (such as swelling ankles/feet, unusual||
1795|105|S|tiredness, unusual/sudden weight gain).||
1795|106|S|   Ibuprofen may rarely cause serious (possibly fatal) liver||
1795|107|S|disease. Get medical help right away if you have any symptoms of||
1795|108|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
1795|109|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1795|110|S|urine.||
1795|111|S|   A very serious allergic reaction to this drug is rare.||
1795|112|S|However, get medical help right away if you notice any symptoms||
1795|113|S|of a serious allergic reaction, including: fever, swollen lymph||
1795|114|S|nodes, rash, itching/swelling (especially of the||
1795|115|S|face/tongue/throat), severe dizziness, trouble breathing.||
1795|116|S|   This is not a complete list of possible side effects. If you||
1795|117|S|notice other effects not listed above, contact your doctor or||
1795|118|S|pharmacist.||
1795|119|S|   In the US -||
1795|120|S|   Call your doctor for medical advice about side effects. You||
1795|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1795|122|S|www.fda.gov/medwatch.||
1795|123|S|   In Canada - Call your doctor for medical advice about side||
1795|124|S|effects. You may report side effects to Health Canada at||
1795|125|S|1-866-234-2345.||
1795|126|B|||
1795|127|P|PRECAUTIONS:  Before taking ibuprofen, tell your doctor or||
1795|128|P|pharmacist if you are allergic to it; or to aspirin or other||
1795|129|P|NSAIDs (such as naproxen, celecoxib); or if you have any other||
1795|130|P|allergies. This product may contain inactive ingredients, which||
1795|131|P|can cause allergic reactions or other problems. Talk to your||
1795|132|P|pharmacist for more details.||
1795|133|P|   Before taking this medication, tell your doctor or pharmacist||
1795|134|P|your medical history, especially of: asthma (including a history||
1795|135|P|of worsening breathing after taking aspirin or other NSAIDs),||
1795|136|P|bleeding/blood problems (such as anemia), growths in the nose||
1795|137|P|(nasal polyps), heart disease (such as previous heart attack),||
1795|138|P|high blood pressure, liver disease, stroke, swelling (edema,||
1795|139|P|fluid retention), stomach/intestinal/esophagus problems (such as||
1795|140|P|bleeding, heartburn, ulcers).||
1795|141|P|   Kidney problems can sometimes occur with the use of NSAID||
1795|142|P|medications, including ibuprofen. Problems are more likely to||
1795|143|P|occur if you are dehydrated, have heart failure or kidney||
1795|144|P|disease, are an older adult, or if you take certain medications||
1795|145|P|(see also Drug Interactions section). Drink plenty of fluids as||
1795|146|P|directed by your doctor to prevent dehydration and tell your||
1795|147|P|doctor right away if you have any unusual change in the amount of||
1795|148|P|urine.||
1795|149|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1795|150|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1795|151|P|machinery, or do anything that needs alertness until you can do||
1795|152|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1795|153|P|are using marijuana (cannabis).||
1795|154|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1795|155|P|and tobacco, especially when combined with this medicine, may||
1795|156|P|increase your risk for stomach bleeding. Limit alcohol and stop||
1795|157|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
1795|158|P|may safely drink.||
1795|159|P|   This medication may make you more sensitive to the sun. Limit||
1795|160|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1795|161|P|sunscreen and wear protective clothing when outdoors. Tell your||
1795|162|P|doctor right away if you get sunburned or have skin||
1795|163|P|blisters/redness.||
1795|164|P|   Before having surgery, tell your doctor or dentist about all||
1795|165|P|the products you use (including prescription drugs,||
1795|166|P|nonprescription drugs, and herbal products).||
1795|167|P|   Older adults may be at greater risk for stomach/intestinal||
1795|168|P|bleeding, kidney problems, heart attack, and stroke while using||
1795|169|P|this drug.||
1795|170|P|   Before using this medication, women of childbearing age should||
1795|171|P|talk with their doctor(s) about the benefits and risks. Tell your||
1795|172|P|doctor if you are pregnant or if you plan to become pregnant.||
1795|173|P|This medication may harm an unborn baby and cause problems with||
1795|174|P|normal labor/delivery. It is not recommended for use in pregnancy||
1795|175|P|from 20 weeks until delivery. If your doctor decides that you||
1795|176|P|need to use this medication between 20 and 30 weeks of pregnancy,||
1795|177|P|you should use the lowest effective dose for the shortest||
1795|178|P|possible time. You should not use this medication after 30 weeks||
1795|179|P|of pregnancy.||
1795|180|P|   This medication passes into breast milk, but is unlikely to||
1795|181|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1795|182|B|||
1795|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1795|184|I|medications work or increase your risk for serious side effects.||
1795|185|I|This document does not contain all possible drug interactions.||
1795|186|I|Keep a list of all the products you use (including||
1795|187|I|prescription/nonprescription drugs and herbal products) and share||
1795|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
1795|189|I|the dosage of any medicines without your doctor's approval.||
1795|190|I|   Some products that may interact with this drug include:||
1795|191|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
1795|192|I|angiotensin II receptor blockers (such as losartan, valsartan),||
1795|193|I|cidofovir, corticosteroids (such as dexamethasone, prednisone),||
1795|194|I|lithium, methotrexate, "water pills" (diuretics such as||
1795|195|I|furosemide).||
1795|196|I|   This medication may increase the risk of bleeding when taken||
1795|197|I|with other drugs that also may cause bleeding. Examples include||
1795|198|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
1795|199|I|dabigatran/enoxaparin/warfarin, among others.||
1795|200|I|   Check all prescription and nonprescription medicine labels||
1795|201|I|carefully since many medications contain pain relievers/fever||
1795|202|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
1795|203|I|or naproxen). These drugs are similar to ibuprofen and may||
1795|204|I|increase your risk of side effects if taken together. However, if||
1795|205|I|your doctor has told you to take low-dose aspirin to prevent||
1795|206|I|heart attack or stroke (usually 81-162 milligrams a day), you||
1795|207|I|should keep taking the aspirin unless your doctor tells you not||
1795|208|I|to. Daily use of ibuprofen may decrease aspirin's ability to||
1795|209|I|prevent heart attack/stroke. Talk to your doctor about using a||
1795|210|I|different medication (such as acetaminophen) to treat pain/fever.||
1795|211|I|If you must take ibuprofen, talk to your doctor about taking||
1795|212|I|immediate-release aspirin (not enteric-coated/EC) while taking||
1795|213|I|ibuprofen. Take ibuprofen at least 8 hours before or at least 2||
1795|214|I|hours after your aspirin dose. Do not increase your daily dose of||
1795|215|I|aspirin or change the way you take aspirin/other medications||
1795|216|I|without your doctor's approval.||
1795|217|B|||
1795|218|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1795|219|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1795|220|O|poison control center right away. US residents can call||
1795|221|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1795|222|O|Symptoms of overdose may include: severe stomach pain, trouble||
1795|223|O|breathing, extreme drowsiness.||
1795|224|B|||
1795|225|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1795|226|N|liver/kidney function, blood pressure) may be done while you are||
1795|227|N|using this medication. Keep all medical and lab appointments.||
1795|228|B|||
1795|229|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
1795|230|D|(not just "as needed") and you miss a dose, take it as soon as||
1795|231|D|you remember. If it is near the time of the next dose, skip the||
1795|232|D|missed dose. Take your next dose at the regular time. Do not||
1795|233|D|double the dose to catch up.||
1795|234|B|||
1795|235|R|STORAGE:  Store at room temperature away from light and moisture.||
1795|236|R|Do not store in the bathroom. Keep all medications away from||
1795|237|R|children and pets.||
1795|238|R|   Do not flush medications down the toilet or pour them into a||
1795|239|R|drain unless instructed to do so. Properly discard this product||
1795|240|R|when it is expired or no longer needed. Consult your pharmacist||
1795|241|R|or local waste disposal company.||
1795|242|B|||
1795|243|A|Information last revised January 2025.||
1795|244|A|Copyright(c) 2025 First Databank, Inc.||
1795|245|B|||
1797|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1797|002|Z|does NOT have all possible information about this product. This||
1797|003|Z|information does not assure that this product is safe, effective,||
1797|004|Z|or appropriate for you. This information is not individual||
1797|005|Z|medical advice and does not substitute for the advice of your||
1797|006|Z|health care professional. Always ask your health care||
1797|007|Z|professional for complete information about this product and your||
1797|008|Z|specific health needs.||
1797|009|B|||
1797|010|T|GALSULFASE - INJECTION||
1797|011|F|(gal-SUL-fase)||
1797|012|B|||
1797|013|C|COMMON BRAND NAME(S): Naglazyme||
1797|014|B|||
1797|015|W|WARNING:  Galsulfase may cause serious (sometimes fatal) allergic||
1797|016|W|reactions during the infusion of this drug and for 24 hours||
1797|017|W|afterward. Get medical help right away if you have any symptoms||
1797|018|W|of a serious allergic reaction such as rash, itching/swelling||
1797|019|W|(especially of the face/tongue/throat), severe dizziness, or||
1797|020|W|trouble breathing.||
1797|021|B|||
1797|022|U|USES:  Galsulfase is used to treat a certain rare genetic problem||
1797|023|U|(Maroteaux-Lamy syndrome - MLS). Galsulfase replaces a certain||
1797|024|U|natural substance that is missing in people with MLS.||
1797|025|U|   This medication improves how far you can walk and the number||
1797|026|U|of stairs you can climb up. Galsulfase does not correct the||
1797|027|U|genetic problem, and treatment must be continued for life.||
1797|028|B|||
1797|029|H|HOW TO USE:  This medication is given by injection into a vein by||
1797|030|H|a health care professional. It is given as directed by your||
1797|031|H|doctor, usually once a week. It is injected slowly into a vein||
1797|032|H|over 4 hours. The dosage is based on your weight, medical||
1797|033|H|condition, and response to treatment.||
1797|034|H|   Infusion reactions may happen during the infusion of this||
1797|035|H|drug. Your doctor may prescribe other medications (such as||
1797|036|H|antihistamines, drugs for fever) before each treatment to help||
1797|037|H|prevent these side effects. Tell your doctor right away if you||
1797|038|H|have any symptoms of infusion reactions such as fever, chills,||
1797|039|H|shortness of breath, nausea/vomiting, increased blood pressure,||
1797|040|H|headache, chest pain, dizziness, weakness/tiredness, joint pain,||
1797|041|H|flushing, or coughing. Your doctor may give you other medications||
1797|042|H|to help with these side effects or may slow down or stop your||
1797|043|H|treatment for some time.||
1797|044|H|   Use this medication regularly to get the most benefit from it.||
1797|045|H|To help you remember, use it on the same day each week.||
1797|046|H|   Tell your doctor if your condition gets worse.||
1797|047|B|||
1797|048|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1797|049|S|   Ear pain, eye redness/itching/discharge, or stomach/abdominal||
1797|050|S|pain may occur. If any of these effects last or get worse, tell||
1797|051|S|your doctor or pharmacist promptly.||
1797|052|S|   Remember that this medication has been prescribed because your||
1797|053|S|doctor has judged that the benefit to you is greater than the||
1797|054|S|risk of side effects. Many people using this medication do not||
1797|055|S|have serious side effects.||
1797|056|S|   Tell your doctor right away if you have any serious side||
1797|057|S|effects, including: vision/hearing changes, back pain, inability||
1797|058|S|to move arms/legs, inability to control urine/stool, signs of||
1797|059|S|kidney problems (such as change in the amount of urine).||
1797|060|S|   This is not a complete list of possible side effects. If you||
1797|061|S|notice other effects not listed above, contact your doctor or||
1797|062|S|pharmacist.||
1797|063|S|   In the US -||
1797|064|S|   Call your doctor for medical advice about side effects. You||
1797|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1797|066|S|www.fda.gov/medwatch.||
1797|067|S|   In Canada - Call your doctor for medical advice about side||
1797|068|S|effects. You may report side effects to Health Canada at||
1797|069|S|1-866-234-2345.||
1797|070|B|||
1797|071|P|PRECAUTIONS:  Before using galsulfase, tell your doctor or||
1797|072|P|pharmacist if you are allergic to it; or if you have any other||
1797|073|P|allergies. This product may contain inactive ingredients, which||
1797|074|P|can cause allergic reactions or other problems. Talk to your||
1797|075|P|pharmacist for more details.||
1797|076|P|   Before using this medication, tell your doctor or pharmacist||
1797|077|P|your medical history, especially of: heart problems (such as||
1797|078|P|heart failure), lung problems.||
1797|079|P|   Before having surgery, tell your doctor or dentist about all||
1797|080|P|the products you use (including prescription drugs,||
1797|081|P|nonprescription drugs, and herbal products).||
1797|082|P|   During pregnancy, this medication should be used only when||
1797|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
1797|084|P|   It is unknown if this medication passes into breast milk.||
1797|085|P|Consult your doctor before breastfeeding.||
1797|086|B|||
1797|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1797|088|I|medications work or increase your risk for serious side effects.||
1797|089|I|This document does not contain all possible drug interactions.||
1797|090|I|Keep a list of all the products you use (including||
1797|091|I|prescription/nonprescription drugs and herbal products) and share||
1797|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
1797|093|I|the dosage of any medicines without your doctor's approval.||
1797|094|B|||
1797|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1797|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1797|097|O|poison control center right away. US residents can call||
1797|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1797|099|B|||
1797|100|N|NOTES:  Keep all medical and lab appointments.||
1797|101|B|||
1797|102|D|MISSED DOSE:  It is important to get each dose of this medication||
1797|103|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1797|104|D|right away for a new dosing schedule.||
1797|105|B|||
1797|106|R|STORAGE:  Not applicable. This medication is given in a hospital||
1797|107|R|or clinic or doctor's office and will not be stored at home.||
1797|108|B|||
1797|109|A|Information last revised July 2024.||
1797|110|A|Copyright(c) 2025 First Databank, Inc.||
1797|111|B|||
1799|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1799|002|Z|does NOT have all possible information about this product. This||
1799|003|Z|information does not assure that this product is safe, effective,||
1799|004|Z|or appropriate for you. This information is not individual||
1799|005|Z|medical advice and does not substitute for the advice of your||
1799|006|Z|health care professional. Always ask your health care||
1799|007|Z|professional for complete information about this product and your||
1799|008|Z|specific health needs.||
1799|009|B|||
1799|010|T|SILTUXIMAB - INJECTION||
1799|011|F|(sil-TUX-i-mab)||
1799|012|B|||
1799|013|C|COMMON BRAND NAME(S): Sylvant||
1799|014|B|||
1799|015|U|USES:  Siltuximab is used to treat a certain rare illness||
1799|016|U|(multicentric Castleman's disease - MCD) if you do not have HIV||
1799|017|U|or herpes infections. Siltuximab blocks a certain natural||
1799|018|U|substance that affects the immune system.||
1799|019|U|   Siltuximab can improve the symptoms of MCD including lumps||
1799|020|U|under the skin, fever, weakness or tiredness, or night sweats.||
1799|021|B|||
1799|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1799|023|H|from your pharmacist before you start using siltuximab and each||
1799|024|H|time you get a refill. If you have any questions, ask your doctor||
1799|025|H|or pharmacist.||
1799|026|H|   This medication is given by a health care professional. It is||
1799|027|H|given slowly into a vein as directed by your doctor, usually over||
1799|028|H|1 hour every 3 weeks. The dosage is based on your weight, medical||
1799|029|H|condition, and response to treatment.||
1799|030|H|   Infusion reactions may happen during the infusion of this||
1799|031|H|drug. Tell your doctor right away if you have any symptoms of||
1799|032|H|infusion reactions such as chest pain/discomfort, pounding||
1799|033|H|heartbeat, wheezing, dizziness, back pain, flushing, nausea, or||
1799|034|H|vomiting. Your doctor may give you other medications to help with||
1799|035|H|these side effects or may slow down or stop your treatment for||
1799|036|H|some time.||
1799|037|H|   Use this medication regularly to get the most benefit from it.||
1799|038|H|To help you remember, use it on the same day every 3 weeks.||
1799|039|H|   Tell your doctor if your condition gets worse.||
1799|040|B|||
1799|041|S|SIDE EFFECTS:  See also How to Use section.||
1799|042|S|   Dry skin, darkening skin, diarrhea, headache, weight gain,||
1799|043|S|constipation, pain in the arms/legs, or joint pain may occur. If||
1799|044|S|any of these effects last or get worse, tell your doctor or||
1799|045|S|pharmacist promptly.||
1799|046|S|   Remember that this medication has been prescribed because your||
1799|047|S|doctor has judged that the benefit to you is greater than the||
1799|048|S|risk of side effects. Many people using this medication do not||
1799|049|S|have serious side effects.||
1799|050|S|   Tell your doctor right away if you have any serious side||
1799|051|S|effects, including: easy bleeding/bruising, signs of infection||
1799|052|S|(such as sore throat that doesn't go away, fever, chills),||
1799|053|S|stomach/abdominal pain, signs of kidney problems (such as change||
1799|054|S|in the amount of urine).||
1799|055|S|   A very serious allergic reaction to this drug is rare.||
1799|056|S|However, get medical help right away if you notice any symptoms||
1799|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1799|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1799|059|S|breathing.||
1799|060|S|   This is not a complete list of possible side effects. If you||
1799|061|S|notice other effects not listed above, contact your doctor or||
1799|062|S|pharmacist.||
1799|063|S|   In the US -||
1799|064|S|   Call your doctor for medical advice about side effects. You||
1799|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1799|066|S|www.fda.gov/medwatch.||
1799|067|S|   In Canada - Call your doctor for medical advice about side||
1799|068|S|effects. You may report side effects to Health Canada at||
1799|069|S|1-866-234-2345.||
1799|070|B|||
1799|071|P|PRECAUTIONS:  Before taking siltuximab, tell your doctor or||
1799|072|P|pharmacist if you are allergic to it; or if you have any other||
1799|073|P|allergies. This product may contain inactive ingredients, which||
1799|074|P|can cause allergic reactions or other problems. Talk to your||
1799|075|P|pharmacist for more details.||
1799|076|P|   Before using this medication, tell your doctor or pharmacist||
1799|077|P|your medical history, especially of: active infection, HIV||
1799|078|P|infection, a certain herpes infection (human herpes virus-8),||
1799|079|P|stomach/intestinal problems (such as ulcers).||
1799|080|P|   Siltuximab can make you more likely to get infections or may||
1799|081|P|make current infections worse. Stay away from anyone who has an||
1799|082|P|infection that may easily spread (such as chickenpox, COVID-19,||
1799|083|P|measles, flu). Talk to your doctor if you have been exposed to an||
1799|084|P|infection or for more details.||
1799|085|P|   This product may cause live bacterial vaccines (such as||
1799|086|P|typhoid vaccine) to not work well. Tell your health care||
1799|087|P|professional that you are using this medication before having any||
1799|088|P|immunizations/vaccinations.||
1799|089|P|   Before having surgery, tell your doctor or dentist about all||
1799|090|P|the products you use (including prescription drugs,||
1799|091|P|nonprescription drugs, and herbal products).||
1799|092|P|   Tell your doctor if you are pregnant or plan to become||
1799|093|P|pregnant. You should not become pregnant while using siltuximab.||
1799|094|P|Siltuximab may harm an unborn baby. Ask about reliable forms of||
1799|095|P|birth control while using this medication and for 3 months after||
1799|096|P|the last dose. If you become pregnant, talk to your doctor right||
1799|097|P|away about the risks and benefits of this medication.||
1799|098|P|   It is unknown if this medication passes into breast milk.||
1799|099|P|Because of the possible risk to the infant, breastfeeding is not||
1799|100|P|recommended while using this medication and for 3 months after||
1799|101|P|the last dose. Consult your doctor before breastfeeding.||
1799|102|B|||
1799|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1799|104|I|medications work or increase your risk for serious side effects.||
1799|105|I|This document does not contain all possible drug interactions.||
1799|106|I|Keep a list of all the products you use (including||
1799|107|I|prescription/nonprescription drugs and herbal products) and share||
1799|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
1799|109|I|the dosage of any medicines without your doctor's approval.||
1799|110|B|||
1799|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1799|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1799|113|O|poison control center right away. US residents can call||
1799|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1799|115|B|||
1799|116|N|NOTES:  Do not share this medication with others.||
1799|117|N|   Lab and/or medical tests (such as blood counts, platelet||
1799|118|N|counts, uric acid, cholesterol, triglycerides) should be done||
1799|119|N|while you are using this medication. Keep all medical and lab||
1799|120|N|appointments. Consult your doctor for more details.||
1799|121|B|||
1799|122|D|MISSED DOSE:  It is important to get each dose of this medication||
1799|123|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1799|124|D|right away for a new dosing schedule. Do not double the dose to||
1799|125|D|catch up.||
1799|126|B|||
1799|127|R|STORAGE:  Not applicable. This medication is given in a hospital||
1799|128|R|or clinic and will not be stored at home.||
1799|129|B|||
1799|130|A|Information last revised May 2024.||
1799|131|A|Copyright(c) 2025 First Databank, Inc.||
1799|132|B|||
1800|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1800|002|Z|does NOT have all possible information about this product. This||
1800|003|Z|information does not assure that this product is safe, effective,||
1800|004|Z|or appropriate for you. This information is not individual||
1800|005|Z|medical advice and does not substitute for the advice of your||
1800|006|Z|health care professional. Always ask your health care||
1800|007|Z|professional for complete information about this product and your||
1800|008|Z|specific health needs.||
1800|009|B|||
1800|010|T|CALCIFEDIOL - ORAL||
1800|011|F|(KAL-sif-e-DYE-ol)||
1800|012|B|||
1800|013|C|COMMON BRAND NAME(S): Rayaldee||
1800|014|B|||
1800|015|U|USES:  This medication is used to treat people with serious||
1800|016|U|kidney disease whose bodies make too much of a certain natural||
1800|017|U|substance (parathyroid hormone-PTH). High amounts of PTH can||
1800|018|U|affect other minerals in the body (such as calcium, phosphorus)||
1800|019|U|that are needed for strong bones. Calcifediol belongs to a class||
1800|020|U|of drugs known as vitamin D analogs. It works by decreasing PTH||
1800|021|U|and increasing calcium and phosphorus in the body.||
1800|022|B|||
1800|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
1800|024|H|doctor, usually once daily at bedtime. Swallow the capsules||
1800|025|H|whole. Do not crush or chew the capsules. Doing so can release||
1800|026|H|all of the drug at once, increasing the risk of side effects.||
1800|027|H|   The dosage is based on your medical condition and response to||
1800|028|H|treatment. To reduce your risk of side effects, your doctor may||
1800|029|H|direct you to start this medication at a low dose and gradually||
1800|030|H|increase your dose. Follow your doctor's instructions carefully.||
1800|031|H|   Take this medication regularly to get the most benefit from||
1800|032|H|it. To help you remember, take it at the same time each day.||
1800|033|H|   If your doctor has told you to follow a special diet (such as||
1800|034|H|a diet high in calcium), it is very important to follow the diet||
1800|035|H|to get the most benefit from this medication and to prevent||
1800|036|H|serious side effects. Do not take other vitamins/supplements||
1800|037|H|unless directed by your doctor.||
1800|038|B|||
1800|039|S|SIDE EFFECTS:  Calcifediol usually has very few side effects. If||
1800|040|S|you have any unusual side effects, contact your doctor or||
1800|041|S|pharmacist promptly.||
1800|042|S|   Remember that this medication has been prescribed because your||
1800|043|S|doctor has judged that the benefit to you is greater than the||
1800|044|S|risk of side effects. Many people using this medication do not||
1800|045|S|have serious side effects.||
1800|046|S|   Tell your doctor right away if you have any serious side||
1800|047|S|effects, including: bone/joint/muscle pain, loss of appetite,||
1800|048|S|nausea/vomiting, constipation, increased thirst, increased||
1800|049|S|urination, fast/slow/irregular heartbeat, mental/mood changes||
1800|050|S|(such as difficulty thinking clearly), weakness.||
1800|051|S|   A very serious allergic reaction to this drug is rare.||
1800|052|S|However, get medical help right away if you notice any symptoms||
1800|053|S|of a serious allergic reaction, including: rash, itching/swelling||
1800|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1800|055|S|breathing.||
1800|056|S|   This is not a complete list of possible side effects. If you||
1800|057|S|notice other effects not listed above, contact your doctor or||
1800|058|S|pharmacist.||
1800|059|S|   In the US -||
1800|060|S|   Call your doctor for medical advice about side effects. You||
1800|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1800|062|S|www.fda.gov/medwatch.||
1800|063|S|   In Canada - Call your doctor for medical advice about side||
1800|064|S|effects. You may report side effects to Health Canada at||
1800|065|S|1-866-234-2345.||
1800|066|B|||
1800|067|P|PRECAUTIONS:  Before taking calcifediol, tell your doctor or||
1800|068|P|pharmacist if you are allergic to it; or to other vitamin D||
1800|069|P|products (such as calcitriol); or if you have any other||
1800|070|P|allergies. This product may contain inactive ingredients, which||
1800|071|P|can cause allergic reactions or other problems. Talk to your||
1800|072|P|pharmacist for more details.||
1800|073|P|   Before using this medication, tell your doctor or pharmacist||
1800|074|P|your medical history.||
1800|075|P|   Before having surgery, tell your doctor or dentist about all||
1800|076|P|the products you use (including prescription drugs,||
1800|077|P|nonprescription drugs, and herbal products).||
1800|078|P|   During pregnancy, this medication should be used only when||
1800|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
1800|080|P|   It is unknown if this medication passes into breast milk.||
1800|081|P|Consult your doctor before breastfeeding.||
1800|082|B|||
1800|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1800|084|I|medications work or increase your risk for serious side effects.||
1800|085|I|This document does not contain all possible drug interactions.||
1800|086|I|Keep a list of all the products you use (including||
1800|087|I|prescription/nonprescription drugs and herbal products) and share||
1800|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
1800|089|I|the dosage of any medicines without your doctor's approval.||
1800|090|I|   A product that may interact with this drug is: burosumab.||
1800|091|I|   Calcifediol is very similar to other forms of vitamin D. Do||
1800|092|I|not use medications containing other forms of vitamin D while||
1800|093|I|using calcifediol.||
1800|094|B|||
1800|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1800|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1800|097|O|poison control center right away. US residents can call||
1800|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1800|099|B|||
1800|100|N|NOTES:  Do not share this medication with others.||
1800|101|N|   Lab and/or medical tests (such as PTH, calcium/phosphorus,||
1800|102|N|vitamin D levels) should be done while you are taking this||
1800|103|N|medication. Keep all medical and lab appointments.||
1800|104|B|||
1800|105|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1800|106|D|remember. If it is near the time of the next dose, skip the||
1800|107|D|missed dose. Take your next dose at the regular time. Do not||
1800|108|D|double the dose to catch up.||
1800|109|B|||
1800|110|R|STORAGE:  Store at room temperature away from light and moisture.||
1800|111|R|Do not store in the bathroom. Keep all medications away from||
1800|112|R|children and pets.||
1800|113|R|   Do not flush medications down the toilet or pour them into a||
1800|114|R|drain unless instructed to do so. Properly discard this product||
1800|115|R|when it is expired or no longer needed. Consult your pharmacist||
1800|116|R|or local waste disposal company.||
1800|117|B|||
1800|118|A|Information last revised May 2024.||
1800|119|A|Copyright(c) 2025 First Databank, Inc.||
1800|120|B|||
1801|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1801|002|Z|does NOT have all possible information about this product. This||
1801|003|Z|information does not assure that this product is safe, effective,||
1801|004|Z|or appropriate for you. This information is not individual||
1801|005|Z|medical advice and does not substitute for the advice of your||
1801|006|Z|health care professional. Always ask your health care||
1801|007|Z|professional for complete information about this product and your||
1801|008|Z|specific health needs.||
1801|009|B|||
1801|010|T|TENOFOVIR ALAFENAMIDE - ORAL||
1801|011|F|(ten-OF-oh-vir AL-a-FEN-a-mide)||
1801|012|B|||
1801|013|C|COMMON BRAND NAME(S): Vemlidy||
1801|014|B|||
1801|015|W|WARNING:  Your hepatitis B symptoms may get worse or become very||
1801|016|W|serious if you stop taking tenofovir alafenamide. Talk with your||
1801|017|W|doctor before stopping this medication. Your doctor will check||
1801|018|W|liver function tests for several months after you stop.||
1801|019|B|||
1801|020|U|USES:  Tenofovir alafenamide is used to treat chronic hepatitis B||
1801|021|U|infection, a viral infection of the liver. It works by stopping||
1801|022|U|or slowing the growth of the virus. Chronic hepatitis infection||
1801|023|U|can lead to serious liver damage (cirrhosis) and liver cancer.||
1801|024|U|   It is not known if tenofovir alafenamide can cure hepatitis B||
1801|025|U|or can prevent you from passing the virus to others. Practice||
1801|026|U|"safer sex" (such as the use of latex condoms) to lower the risk||
1801|027|U|of passing the virus to others.||
1801|028|B|||
1801|029|H|HOW TO USE:  Before starting treatment with this medication, your||
1801|030|H|doctor should test you for HIV infection. If you have HIV||
1801|031|H|infection along with hepatitis B infection, tenofovir alafenamide||
1801|032|H|should not be used alone since this may make it harder to treat||
1801|033|H|your HIV infection. Combination drug treatment should always be||
1801|034|H|used to treat HIV infection.||
1801|035|H|   Read the Patient Information Leaflet if available from your||
1801|036|H|pharmacist before you start taking tenofovir alafenamide, and||
1801|037|H|each time you get a refill. If you have any questions, ask your||
1801|038|H|doctor or pharmacist.||
1801|039|H|   Take this medication by mouth with food as directed by your||
1801|040|H|doctor, usually once daily.||
1801|041|H|   If you are on dialysis, on your dialysis days, take your daily||
1801|042|H|dose of this medication following dialysis.||
1801|043|H|   The dosage is based on your medical condition, response to||
1801|044|H|treatment, and other medications you may be taking. Be sure to||
1801|045|H|tell your doctor and pharmacist about all the products you use||
1801|046|H|(including prescription drugs, nonprescription drugs, and herbal||
1801|047|H|products).||
1801|048|H|   For the best effect, take this medication at evenly spaced||
1801|049|H|times. To help you remember, take this medication at the same||
1801|050|H|time every day.||
1801|051|H|   If you vomit within 1 hour after taking a dose, take another||
1801|052|H|dose of this medication. If vomiting occurs more than 1 hour||
1801|053|H|after taking your dose, do not take another dose. Take your next||
1801|054|H|dose at the regular time.||
1801|055|H|   Do not take more or less of this drug than prescribed or stop||
1801|056|H|taking it even for a short time unless directed to do so by your||
1801|057|H|doctor. Doing so may make the infection worse or harder to treat||
1801|058|H|(resistant), or worsen side effects.||
1801|059|B|||
1801|060|S|SIDE EFFECTS:  Headache, nausea, tiredness, or cough may occur.||
1801|061|S|If any of these effects last or get worse, tell your doctor or||
1801|062|S|pharmacist promptly.||
1801|063|S|   Remember that this medication has been prescribed because your||
1801|064|S|doctor has judged that the benefit to you is greater than the||
1801|065|S|risk of side effects. Many people using this medication do not||
1801|066|S|have serious side effects.||
1801|067|S|   Tell your doctor right away if you have any serious side||
1801|068|S|effects, including: mental/mood changes (such as depression,||
1801|069|S|anxiety, confusion), signs of kidney problems (such as a change||
1801|070|S|in the amount of urine), unusual thirst.||
1801|071|S|   Rarely, this medication can cause severe (sometimes fatal)||
1801|072|S|liver and blood problems (lactic acidosis). Tell your doctor||
1801|073|S|right away if you develop symptoms of liver problems (such as||
1801|074|S|nausea/vomiting that doesn't stop, loss of appetite,||
1801|075|S|stomach/abdominal pain, yellowing eyes/skin, dark urine) or||
1801|076|S|lactic acidosis (such as deep/rapid breathing, drowsiness,||
1801|077|S|nausea/vomiting, unusual weakness).||
1801|078|S|   A very serious allergic reaction to this drug is rare.||
1801|079|S|However, get medical help right away if you notice any symptoms||
1801|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1801|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1801|082|S|breathing.||
1801|083|S|   This is not a complete list of possible side effects. If you||
1801|084|S|notice other effects not listed above, contact your doctor or||
1801|085|S|pharmacist.||
1801|086|S|   In the US -||
1801|087|S|   Call your doctor for medical advice about side effects. You||
1801|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1801|089|S|www.fda.gov/medwatch.||
1801|090|S|   In Canada - Call your doctor for medical advice about side||
1801|091|S|effects. You may report side effects to Health Canada at||
1801|092|S|1-866-234-2345.||
1801|093|B|||
1801|094|P|PRECAUTIONS:  Before taking tenofovir alafenamide, tell your||
1801|095|P|doctor or pharmacist if you are allergic to it; or if you have||
1801|096|P|any other allergies. This product may contain inactive||
1801|097|P|ingredients, which can cause allergic reactions or other||
1801|098|P|problems. Talk to your pharmacist for more details.||
1801|099|P|   Before using this medication, tell your doctor or pharmacist||
1801|100|P|your medical history, especially of: kidney problems, HIV||
1801|101|P|infection, other liver problems (such as hepatitis C, cirrhosis),||
1801|102|P|bone problems (such as bone disease, bone loss/osteoporosis,||
1801|103|P|weak/broken bones), disease of the pancreas (pancreatitis).||
1801|104|P|   Before having surgery, tell your doctor or dentist about all||
1801|105|P|the products you use (including prescription drugs,||
1801|106|P|nonprescription drugs, and herbal products).||
1801|107|P|   During pregnancy, this medication should be used only when||
1801|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
1801|109|P|   This medication passes into breast milk, but is unlikely to||
1801|110|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1801|111|B|||
1801|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1801|113|I|medications work or increase your risk for serious side effects.||
1801|114|I|This document does not contain all possible drug interactions.||
1801|115|I|Keep a list of all the products you use (including||
1801|116|I|prescription/nonprescription drugs and herbal products) and share||
1801|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
1801|118|I|the dosage of any medicines without your doctor's approval.||
1801|119|I|   Some products that may interact with this drug are: adefovir,||
1801|120|I|orlistat, other drugs that may harm the kidneys (including||
1801|121|I|aminoglycosides such as amikacin/gentamicin).||
1801|122|I|   Do not take this medication with other products that contain||
1801|123|I|tenofovir.||
1801|124|B|||
1801|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1801|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1801|127|O|poison control center right away. US residents can call||
1801|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1801|129|B|||
1801|130|N|NOTES:  Do not share this medication with others.||
1801|131|N|   Lab and/or medical tests (such as kidney/liver function, urine||
1801|132|N|glucose/protein, hepatitis B virus levels, blood mineral levels,||
1801|133|N|bone density tests) should be done before you start taking this||
1801|134|N|medication and while you are taking it. Keep all medical and lab||
1801|135|N|appointments. Consult your doctor for more details.||
1801|136|B|||
1801|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1801|138|D|remember. If it is more than 18 hours after the missed dose, skip||
1801|139|D|the missed dose. Take your next dose at the regular time. Do not||
1801|140|D|double the dose to catch up.||
1801|141|B|||
1801|142|R|STORAGE:  Store in the original container at room temperature||
1801|143|R|away from light and moisture. Do not store in the bathroom. Keep||
1801|144|R|all medications away from children and pets.||
1801|145|R|   Do not flush medications down the toilet or pour them into a||
1801|146|R|drain unless instructed to do so. Properly discard this product||
1801|147|R|when it is expired or no longer needed. Consult your pharmacist||
1801|148|R|or local waste disposal company.||
1801|149|B|||
1801|150|A|Information last revised May 2024.||
1801|151|A|Copyright(c) 2025 First Databank, Inc.||
1801|152|B|||
1802|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1802|002|Z|does NOT have all possible information about this product. This||
1802|003|Z|information does not assure that this product is safe, effective,||
1802|004|Z|or appropriate for you. This information is not individual||
1802|005|Z|medical advice and does not substitute for the advice of your||
1802|006|Z|health care professional. Always ask your health care||
1802|007|Z|professional for complete information about this product and your||
1802|008|Z|specific health needs.||
1802|009|B|||
1802|010|T|INSULIN DEGLUDEC/LIRAGLUTIDE - INJECTION||
1802|011|F|(IN-su-lin de-GLOO-dek/LIR-a-GLOO-tide)||
1802|012|B|||
1802|013|C|COMMON BRAND NAME(S): Xultophy||
1802|014|B|||
1802|015|W|WARNING:  This medication can cause a certain type of thyroid||
1802|016|W|tumor (thyroid C-cell tumors) in rats and mice. It is unknown if||
1802|017|W|this medication can cause similar tumors in humans. Talk with||
1802|018|W|your doctor about the benefits and risks of treatment with this||
1802|019|W|medication. Do not use this medication if you have a certain||
1802|020|W|inherited disease (multiple endocrine neoplasia syndrome type 2||
1802|021|W|or MEN 2) or if you have a personal/family history of a certain||
1802|022|W|type of cancer (medullary thyroid carcinoma). While using this||
1802|023|W|medication, tell your doctor right away if you notice any signs||
1802|024|W|or symptoms of thyroid tumors, including unusual growth or lump||
1802|025|W|in the neck, difficulty swallowing, shortness of breath, or||
1802|026|W|unusual/lasting hoarseness.||
1802|027|B|||
1802|028|U|USES:  This medication is a combination of insulin degludec and||
1802|029|U|liraglutide and is used with a proper diet and exercise program||
1802|030|U|to control high blood sugar in people with type 2 diabetes.||
1802|031|U|Controlling high blood sugar helps prevent kidney damage,||
1802|032|U|blindness, nerve problems, loss of limbs, and sexual function||
1802|033|U|problems. Proper control of diabetes may also lessen your risk of||
1802|034|U|a heart attack or stroke.||
1802|035|U|   Insulin degludec is a man-made product that is similar to||
1802|036|U|human insulin. It acts longer than regular insulin, providing a||
1802|037|U|low, steady level of insulin. It works by helping blood sugar||
1802|038|U|(glucose) get into cells so your body can use it for energy.||
1802|039|U|Liraglutide is similar to a natural hormone in your body||
1802|040|U|(incretin). It works by causing insulin release in response to||
1802|041|U|high sugar levels (such as after a meal) and decreasing the||
1802|042|U|amount of sugar your liver makes.||
1802|043|B|||
1802|044|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1802|045|H|provided by your pharmacist before you start using this||
1802|046|H|medication and each time you get a refill. Ask your health care||
1802|047|H|professional how to prepare and use this medication. If you have||
1802|048|H|any questions, ask your doctor or pharmacist.||
1802|049|H|   Inject this medication under the skin as directed by your||
1802|050|H|doctor, usually once daily. This medication may be used with or||
1802|051|H|without food. The injection is given in the thigh, abdomen, or||
1802|052|H|upper arm. Do not inject into a vein or muscle because very low||
1802|053|H|blood sugar (hypoglycemia) may occur.||
1802|054|H|   The dosage is based on your medical condition and response to||
1802|055|H|treatment. Your doctor will start you on a low dose first to||
1802|056|H|decrease your risk of stomach/abdominal side effects, and||
1802|057|H|gradually increase your dose. If more than 3 days have passed||
1802|058|H|since your last dose of this medication, ask your doctor if you||
1802|059|H|should restart the medication with the low dose to reduce your||
1802|060|H|chance of side effects. Follow your doctor's instructions||
1802|061|H|carefully.||
1802|062|H|   Before using, check this product for particles or||
1802|063|H|discoloration. If either is present, do not use the liquid.||
1802|064|H|Before injecting each dose, clean the skin you are going to||
1802|065|H|inject into (the injection site) with rubbing alcohol. Change the||
1802|066|H|injection site each time to lessen injury under the skin (for||
1802|067|H|example, pits/lumps or thickened skin). Do not inject into skin||
1802|068|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
1802|069|H|not rub the injection site after a shot. Learn how to store and||
1802|070|H|discard medical supplies safely.||
1802|071|H|   Do not share your pen device with another person, even if the||
1802|072|H|needle is changed. You may give other people a serious infection,||
1802|073|H|or get a serious infection from them.||
1802|074|H|   Use this medication regularly to get the most benefit from it.||
1802|075|H|To help you remember, use it at the same time each day.||
1802|076|H|   Tell your doctor if your condition does not get better or if||
1802|077|H|it gets worse (your blood sugar is too high or too low).||
1802|078|B|||
1802|079|S|SIDE EFFECTS:  See also Warning section.||
1802|080|S|   Nausea, vomiting, stomach upset, decreased appetite, diarrhea,||
1802|081|S|constipation, stuffy/runny nose, weight gain, or||
1802|082|S|pain/redness/irritation at the injection site may occur. Nausea||
1802|083|S|usually lessens as you continue to use this medication. If any of||
1802|084|S|these effects last or get worse, tell your doctor or pharmacist||
1802|085|S|promptly.||
1802|086|S|   Remember that this medication has been prescribed because your||
1802|087|S|doctor has judged that the benefit to you is greater than the||
1802|088|S|risk of side effects. Many people using this medication do not||
1802|089|S|have serious side effects.||
1802|090|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
1802|091|S|Contact your doctor promptly if you notice any symptoms of||
1802|092|S|dehydration, such as unusual dry mouth/thirst, fast heartbeat, or||
1802|093|S|dizziness/lightheadedness.||
1802|094|S|   Tell your doctor right away if you have any serious side||
1802|095|S|effects, including: signs of low potassium level in the blood||
1802|096|S|(such as muscle cramps, weakness, irregular heartbeat), signs of||
1802|097|S|kidney problems (such as change in the amount of urine),||
1802|098|S|mental/mood changes (such as depression, thoughts of suicide).||
1802|099|S|   Get medical help right away if you have any very serious side||
1802|100|S|effects, including: signs of pancreas or gallbladder disease||
1802|101|S|(such as nausea/vomiting that doesn't stop, severe||
1802|102|S|stomach/abdominal pain).||
1802|103|S|   This medication can cause low blood sugar (hypoglycemia). This||
1802|104|S|may occur if you do not get enough calories from food or if you||
1802|105|S|do unusually heavy exercise. Symptoms of low blood sugar include||
1802|106|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
1802|107|S|dizziness, or tingling hands/feet. It is a good habit to carry||
1802|108|S|glucose tablets or gel to treat low blood sugar. If you don't||
1802|109|S|have these reliable forms of glucose, rapidly raise your blood||
1802|110|S|sugar by eating a quick source of sugar such as table sugar,||
1802|111|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
1802|112|S|doctor right away about the reaction and the use of this product.||
1802|113|S|To help prevent low blood sugar, eat meals on a regular schedule,||
1802|114|S|and do not skip meals. Check with your doctor or pharmacist to||
1802|115|S|find out what you should do if you miss a meal.||
1802|116|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1802|117|S|thirst/urination. If these symptoms occur, tell your doctor right||
1802|118|S|away. Your doctor may need to adjust your diabetes medication,||
1802|119|S|exercise program, or diet.||
1802|120|S|   A very serious allergic reaction to this drug is rare.||
1802|121|S|However, get medical help right away if you notice any symptoms||
1802|122|S|of a serious allergic reaction, including: rash, itching/swelling||
1802|123|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1802|124|S|breathing.||
1802|125|S|   This is not a complete list of possible side effects. If you||
1802|126|S|notice other effects not listed above, contact your doctor or||
1802|127|S|pharmacist.||
1802|128|S|   In the US -||
1802|129|S|   Call your doctor for medical advice about side effects. You||
1802|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1802|131|S|www.fda.gov/medwatch.||
1802|132|S|   In Canada - Call your doctor for medical advice about side||
1802|133|S|effects. You may report side effects to Health Canada at||
1802|134|S|1-866-234-2345.||
1802|135|B|||
1802|136|P|PRECAUTIONS:  See also Warning section.||
1802|137|P|   Before using this medication, tell your doctor or pharmacist||
1802|138|P|if you are allergic to insulin degludec or liraglutide; or if you||
1802|139|P|have any other allergies. This product may contain inactive||
1802|140|P|ingredients, which can cause allergic reactions or other||
1802|141|P|problems. Talk to your pharmacist for more details.||
1802|142|P|   Do not use this medication when you have low blood sugar||
1802|143|P|(hypoglycemia).||
1802|144|P|   Before using this medication, tell your doctor or pharmacist||
1802|145|P|your medical history, especially of: kidney disease, liver||
1802|146|P|disease, disease of the pancreas (pancreatitis), gallbladder||
1802|147|P|disease, stomach/intestinal disorders (such as gastroparesis),||
1802|148|P|mental/mood disorders (such as depression, thoughts of suicide).||
1802|149|P|   You may experience blurred vision, dizziness, or drowsiness||
1802|150|P|due to extremely low or high blood sugar. Do not drive, use||
1802|151|P|machinery, or do anything that needs alertness or clear vision||
1802|152|P|until you can do it safely.||
1802|153|P|   Limit alcohol while using this medication because it can||
1802|154|P|increase your risk of developing low blood sugar.||
1802|155|P|   It may be harder to control your blood sugar when your body is||
1802|156|P|stressed (such as due to fever, infection, injury, or surgery).||
1802|157|P|Consult your doctor because this may require a change in your||
1802|158|P|treatment plan, medications, or blood sugar testing.||
1802|159|P|   Before having surgery, tell your doctor or dentist about all||
1802|160|P|the products you use (including prescription drugs,||
1802|161|P|nonprescription drugs, and herbal products).||
1802|162|P|   Check your blood sugar before and after exercise. You may need||
1802|163|P|a snack beforehand.||
1802|164|P|   Older adults may be more sensitive to the side effects of this||
1802|165|P|drug, especially low blood sugar.||
1802|166|P|   During pregnancy, this medication should be used only when||
1802|167|P|clearly needed. Discuss the risks and benefits with your doctor.||
1802|168|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1802|169|P|your doctor for managing your blood sugar while pregnant. Your||
1802|170|P|doctor may change your diabetes treatment during your pregnancy||
1802|171|P|(such as diet and medications including insulin).||
1802|172|P|   Insulin degludec passes into breast milk. It is unknown if||
1802|173|P|liraglutide passes into breast milk. Consult your doctor before||
1802|174|P|breastfeeding.||
1802|175|B|||
1802|176|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1802|177|I|medications work or increase your risk for serious side effects.||
1802|178|I|This document does not contain all possible drug interactions.||
1802|179|I|Keep a list of all the products you use (including||
1802|180|I|prescription/nonprescription drugs and herbal products) and share||
1802|181|I|it with your doctor and pharmacist. Do not start, stop, or change||
1802|182|I|the dosage of any medicines without your doctor's approval.||
1802|183|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1802|184|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1802|185|I|heartbeat you would usually feel when your blood sugar falls too||
1802|186|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1802|187|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1802|188|I|   Many drugs can affect your blood sugar levels, making it more||
1802|189|I|difficult to control your blood sugar. Before you start, stop, or||
1802|190|I|change any medication, talk with your doctor or pharmacist about||
1802|191|I|how the medication may affect your blood sugar. Check your blood||
1802|192|I|sugar regularly as directed by your doctor. Tell your doctor||
1802|193|I|about the results and of any symptoms of high or low blood sugar.||
1802|194|I|(See also Side Effects section.) Your doctor may need to adjust||
1802|195|I|your diabetes medication, exercise program, or diet.||
1802|196|B|||
1802|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1802|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1802|199|O|poison control center right away. US residents can call||
1802|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1802|201|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
1802|202|O|sweating, loss of consciousness.||
1802|203|B|||
1802|204|N|NOTES:  Do not share this medication with others.||
1802|205|N|   Attend a diabetes education program to learn more about how to||
1802|206|N|manage your diabetes with medications, diet, exercise, and||
1802|207|N|regular medical exams.||
1802|208|N|   Learn the symptoms of high and low blood sugar and how to||
1802|209|N|treat low blood sugar. Check your blood sugar regularly as||
1802|210|N|directed and share the results with your doctor.||
1802|211|N|   Lab and/or medical tests (such as liver/kidney function,||
1802|212|N|fasting blood glucose, hemoglobin A1c) should be done while you||
1802|213|N|are using this medication. Keep all medical and lab appointments.||
1802|214|B|||
1802|215|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1802|216|D|next dose at the regular time. Do not double the dose to catch||
1802|217|D|up.||
1802|218|B|||
1802|219|R|STORAGE:  Store in the refrigerator before first use. Do not||
1802|220|R|freeze. Do not use this medication if it has been frozen. Keep||
1802|221|R|the medication in the original carton to protect from light. If||
1802|222|R|the unopened medication is stored at room temperature, discard||
1802|223|R|after 21 days. After first use, store the medication at room||
1802|224|R|temperature or in the refrigerator away from heat and light.||
1802|225|R|Discard the medication 21 days after first use, even if some drug||
1802|226|R|remains in the pen. Keep all medications away from children and||
1802|227|R|pets.||
1802|228|R|   Do not flush medications down the toilet or pour them into a||
1802|229|R|drain unless instructed to do so. Properly discard this product||
1802|230|R|when it is expired or no longer needed. Consult your pharmacist||
1802|231|R|or local waste disposal company.||
1802|232|B|||
1802|233|M|MEDICAL ALERT:  Your condition can cause complications in a||
1802|234|M|medical emergency. For information about enrolling in MedicAlert,||
1802|235|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1802|236|B|||
1802|237|A|Information last revised April 2025.||
1802|238|A|Copyright(c) 2025 First Databank, Inc.||
1802|239|B|||
1803|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1803|002|Z|does NOT have all possible information about this product. This||
1803|003|Z|information does not assure that this product is safe, effective,||
1803|004|Z|or appropriate for you. This information is not individual||
1803|005|Z|medical advice and does not substitute for the advice of your||
1803|006|Z|health care professional. Always ask your health care||
1803|007|Z|professional for complete information about this product and your||
1803|008|Z|specific health needs.||
1803|009|B|||
1803|010|T|DECITABINE - INJECTION||
1803|011|F|(dee-SYE-ta-been)||
1803|012|B|||
1803|013|C|COMMON BRAND NAME(S): Dacogen||
1803|014|B|||
1803|015|U|USES:  This medication is used to treat a group of blood/bone||
1803|016|U|marrow disorders (myelodysplastic syndromes-MDS) in which the||
1803|017|U|bone marrow does not produce enough healthy blood cells. People||
1803|018|U|with MDS may have problems such as infections, anemia, and easy||
1803|019|U|bleeding/bruising. Decitabine is a chemotherapy drug. It is||
1803|020|U|believed to work by helping your bone marrow grow normal blood||
1803|021|U|cells so you will need fewer blood transfusions. Decitabine also||
1803|022|U|kills abnormal blood cells that have grown too fast and do not||
1803|023|U|work properly.||
1803|024|B|||
1803|025|H|HOW TO USE:  This medication is given by injection into a vein by||
1803|026|H|a health care professional in a hospital or infusion clinic.||
1803|027|H|   The dosage is based on your medical condition, body size, lab||
1803|028|H|test results, and response to treatment. Keep all medical/lab||
1803|029|H|appointments.||
1803|030|H|   This medication can be injected once a day for 5 days in a row||
1803|031|H|or injected every 8 hours for 3 days in a row, as directed by||
1803|032|H|your doctor. Your treatment cycle will be repeated every 4 weeks||
1803|033|H|if you are on a 5-day course, or every 6 weeks if you are on a||
1803|034|H|3-day course, and depending on your response to the medication||
1803|035|H|and blood tests.||
1803|036|H|   Use this medication regularly to get the most benefit from it.||
1803|037|H|To help you remember, use it at the same time(s) each day during||
1803|038|H|your treatment cycle.||
1803|039|H|   Tell your doctor if your condition gets worse.||
1803|040|B|||
1803|041|S|SIDE EFFECTS:  Redness/pain/bruising at the injection site,||
1803|042|S|nausea, constipation, diarrhea, vomiting, upset stomach, trouble||
1803|043|S|sleeping, hair loss, or muscle/joint pain may occur. Nausea and||
1803|044|S|vomiting can be severe. In some cases, your doctor may prescribe||
1803|045|S|medication to prevent or relieve nausea and vomiting. Eating||
1803|046|S|several small meals, not eating before treatment, or limiting||
1803|047|S|activity may help lessen some of these effects. If any of these||
1803|048|S|effects last or get worse, tell your doctor or pharmacist||
1803|049|S|promptly.||
1803|050|S|   People using this medication may have serious side effects.||
1803|051|S|However, you have been prescribed this drug because your doctor||
1803|052|S|has judged that the benefit to you is greater than the risk of||
1803|053|S|side effects. Careful monitoring by your doctor may decrease your||
1803|054|S|risk.||
1803|055|S|   Tell your doctor right away if you have any serious side||
1803|056|S|effects, including: confusion, easy bleeding/bruising, unusual||
1803|057|S|tiredness, pale skin, mouth/tongue sores, swollen belly,||
1803|058|S|shortness of breath.||
1803|059|S|   This medication may make your blood sugar rise, which can||
1803|060|S|cause or worsen diabetes. Tell your doctor right away if you have||
1803|061|S|symptoms of high blood sugar, such as increased thirst/urination.||
1803|062|S|If you already have diabetes, check your blood sugar regularly as||
1803|063|S|directed and share the results with your doctor. Your doctor may||
1803|064|S|need to adjust your diabetes medication, exercise program, or||
1803|065|S|diet.||
1803|066|S|   Though decitabine is supposed to improve the body's immune||
1803|067|S|system, in some patients this medication may lower your ability||
1803|068|S|to fight infections. This may make you more likely to get a||
1803|069|S|serious (rarely fatal) infection or make any infection you have||
1803|070|S|worse. Tell your doctor right away if you have any signs of||
1803|071|S|infection (such as sore throat that doesn't go away, fever,||
1803|072|S|chills).||
1803|073|S|   A very serious allergic reaction to this drug is rare.||
1803|074|S|However, get medical help right away if you notice any symptoms||
1803|075|S|of a serious allergic reaction, including: rash, itching/swelling||
1803|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1803|077|S|breathing.||
1803|078|S|   This is not a complete list of possible side effects. If you||
1803|079|S|notice other effects not listed above, contact your doctor or||
1803|080|S|pharmacist.||
1803|081|S|   In the US -||
1803|082|S|   Call your doctor for medical advice about side effects. You||
1803|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1803|084|S|www.fda.gov/medwatch.||
1803|085|S|   In Canada - Call your doctor for medical advice about side||
1803|086|S|effects. You may report side effects to Health Canada at||
1803|087|S|1-866-234-2345.||
1803|088|B|||
1803|089|P|PRECAUTIONS:  Before using decitabine, tell your doctor or||
1803|090|P|pharmacist if you are allergic to it; or if you have any other||
1803|091|P|allergies. This product may contain inactive ingredients, which||
1803|092|P|can cause allergic reactions or other problems. Talk to your||
1803|093|P|pharmacist for more details.||
1803|094|P|   Before using this medication, tell your doctor or pharmacist||
1803|095|P|your medical history.||
1803|096|P|   Tell your health care professional that you are using||
1803|097|P|decitabine before having any immunizations/vaccinations. Avoid||
1803|098|P|contact with people who have recently received live vaccines||
1803|099|P|(such as flu vaccine inhaled through the nose).||
1803|100|P|   To lower the chance of getting cut, bruised, or injured, use||
1803|101|P|caution with sharp objects like razors and nail cutters, and||
1803|102|P|avoid activities such as contact sports.||
1803|103|P|   Before having surgery, tell your doctor or dentist about all||
1803|104|P|the products you use (including prescription drugs,||
1803|105|P|nonprescription drugs, and herbal products).||
1803|106|P|   Tell your doctor if you are pregnant or plan to become||
1803|107|P|pregnant. You should not become pregnant while using decitabine.||
1803|108|P|Decitabine may harm an unborn baby. Your doctor should order a||
1803|109|P|pregnancy test before you start this medication. Women using this||
1803|110|P|medication should ask about reliable forms of birth control||
1803|111|P|during treatment and for at least 6 months after the last dose.||
1803|112|P|Men using this medication should ask about reliable forms of||
1803|113|P|birth control during treatment and for at least 3 months after||
1803|114|P|the last dose. If you or your partner becomes pregnant, talk to||
1803|115|P|your doctor right away about the risks and benefits of this||
1803|116|P|medication.||
1803|117|P|   It is unknown if this drug passes into breast milk. Because of||
1803|118|P|the possible risk to the infant, breastfeeding is not recommended||
1803|119|P|while using this drug and for at least 2 weeks after the last||
1803|120|P|dose. Consult your doctor before breastfeeding.||
1803|121|B|||
1803|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1803|123|I|medications work or increase your risk for serious side effects.||
1803|124|I|This document does not contain all possible drug interactions.||
1803|125|I|Keep a list of all the products you use (including||
1803|126|I|prescription/nonprescription drugs and herbal products) and share||
1803|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
1803|128|I|the dosage of any medicines without your doctor's approval.||
1803|129|B|||
1803|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1803|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1803|132|O|poison control center right away. US residents can call||
1803|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1803|134|B|||
1803|135|N|NOTES:  Lab tests (such as complete blood counts, platelet||
1803|136|N|counts, liver/kidney function) should be done while you are using||
1803|137|N|this medication. Keep all medical and lab appointments. Consult||
1803|138|N|your doctor for more details.||
1803|139|B|||
1803|140|D|MISSED DOSE:  It is important to get each dose of this medication||
1803|141|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1803|142|D|right away for a new dosing schedule. Do not double the dose to||
1803|143|D|catch up.||
1803|144|B|||
1803|145|R|STORAGE:  Not applicable. This medication is given in a clinic||
1803|146|R|and will not be stored at home.||
1803|147|B|||
1803|148|M|MEDICAL ALERT:  Your condition can cause complications in a||
1803|149|M|medical emergency. For information about enrolling in MedicAlert,||
1803|150|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1803|151|B|||
1803|152|A|Information last revised April 2025.||
1803|153|A|Copyright(c) 2025 First Databank, Inc.||
1803|154|B|||
1804|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1804|002|Z|does NOT have all possible information about this product. This||
1804|003|Z|information does not assure that this product is safe, effective,||
1804|004|Z|or appropriate for you. This information is not individual||
1804|005|Z|medical advice and does not substitute for the advice of your||
1804|006|Z|health care professional. Always ask your health care||
1804|007|Z|professional for complete information about this product and your||
1804|008|Z|specific health needs.||
1804|009|B|||
1804|010|T|INSULIN GLARGINE/LIXISENATIDE - INJECTION||
1804|011|F|(IN-su-lin GLAR-jeen/LIX-i-SEN-a-tide)||
1804|012|B|||
1804|013|C|COMMON BRAND NAME(S): Soliqua||
1804|014|B|||
1804|015|U|USES:  This medication is a combination of insulin glargine and||
1804|016|U|lixisenatide and is used with a proper diet and exercise program||
1804|017|U|to control high blood sugar in people with type 2 diabetes.||
1804|018|U|Controlling high blood sugar helps prevent kidney damage,||
1804|019|U|blindness, nerve problems, loss of limbs, and sexual function||
1804|020|U|problems. Proper control of diabetes may also lessen your risk of||
1804|021|U|a heart attack or stroke.||
1804|022|U|   Insulin glargine is a man-made product that is similar to||
1804|023|U|human insulin. It acts longer than regular insulin, providing a||
1804|024|U|low, steady level of insulin. It works by helping blood sugar||
1804|025|U|(glucose) get into cells so your body can use it for energy.||
1804|026|U|Lixisenatide is similar to a natural hormone in your body||
1804|027|U|(incretin). It works by causing insulin release in response to||
1804|028|U|high sugar levels (such as after a meal) and decreasing the||
1804|029|U|amount of sugar your liver makes.||
1804|030|B|||
1804|031|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1804|032|H|provided by your pharmacist before you start using this||
1804|033|H|medication and each time you get a refill. Ask your health care||
1804|034|H|professional how to prepare and use this medication. If you have||
1804|035|H|any questions, ask your doctor or pharmacist.||
1804|036|H|   Inject this medication under the skin as directed by your||
1804|037|H|doctor, usually once daily within 1 hour before the first meal of||
1804|038|H|the day. The injection is given in the thigh, abdomen, or upper||
1804|039|H|arm. Do not inject into a vein or muscle because very low blood||
1804|040|H|sugar (hypoglycemia) may occur. The dosage is based on your||
1804|041|H|medical condition and response to treatment.||
1804|042|H|   Before using, check this product for particles or||
1804|043|H|discoloration. If either is present, do not use the liquid.||
1804|044|H|Before injecting each dose, clean the skin you are going to||
1804|045|H|inject into (the injection site) with rubbing alcohol. Change the||
1804|046|H|injection site each time to lessen injury under the skin (for||
1804|047|H|example, pits/lumps or thickened skin). Do not inject into skin||
1804|048|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
1804|049|H|not rub the injection site after a shot. Learn how to store and||
1804|050|H|discard medical supplies safely.||
1804|051|H|   Lixisenatide can slow down or decrease the absorption of other||
1804|052|H|drugs such as birth control pills, antibiotics, or acetaminophen.||
1804|053|H|Take other medications at least 1 hour before using this||
1804|054|H|medication. Take birth control pills at least 1 hour before or 11||
1804|055|H|hours after using this medication. If you must take these other||
1804|056|H|medications with food, take them with a meal or snack when you||
1804|057|H|are not using this product. Ask your doctor or pharmacist if you||
1804|058|H|have any questions about when to take your medications.||
1804|059|H|   Do not share your pen device with another person, even if the||
1804|060|H|needle is changed. You may give other people a serious infection,||
1804|061|H|or get a serious infection from them.||
1804|062|H|   Use this medication regularly to get the most benefit from it.||
1804|063|H|To help you remember, use it with the same meal each day.||
1804|064|H|   Tell your doctor if your condition does not get better or if||
1804|065|H|it gets worse (your blood sugar is too high or too low).||
1804|066|B|||
1804|067|S|SIDE EFFECTS:  Nausea, vomiting, stomach upset, decreased||
1804|068|S|appetite, diarrhea, constipation, stuffy/runny nose, weight gain,||
1804|069|S|or pain/redness/irritation at the injection site may occur.||
1804|070|S|Nausea usually lessens as you continue to use this medication. If||
1804|071|S|any of these effects last or get worse, tell your doctor or||
1804|072|S|pharmacist promptly.||
1804|073|S|   Remember that this medication has been prescribed because your||
1804|074|S|doctor has judged that the benefit to you is greater than the||
1804|075|S|risk of side effects. Many people using this medication do not||
1804|076|S|have serious side effects.||
1804|077|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
1804|078|S|Contact your doctor promptly if you notice any symptoms of||
1804|079|S|dehydration, such as unusual dry mouth/thirst, fast heartbeat, or||
1804|080|S|dizziness/lightheadedness.||
1804|081|S|   Tell your doctor right away if you have any serious side||
1804|082|S|effects, including: signs of low potassium level in the blood||
1804|083|S|(such as muscle cramps, weakness, irregular heartbeat), signs of||
1804|084|S|kidney problems (such as change in the amount of urine).||
1804|085|S|   Get medical help right away if you have any very serious side||
1804|086|S|effects, including: signs of pancreas or gallbladder disease||
1804|087|S|(such as nausea/vomiting that doesn't stop, severe||
1804|088|S|stomach/abdominal pain).||
1804|089|S|   This medication can cause low blood sugar (hypoglycemia). This||
1804|090|S|may occur if you do not get enough calories from food or if you||
1804|091|S|do unusually heavy exercise. Symptoms of low blood sugar include||
1804|092|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
1804|093|S|dizziness, or tingling hands/feet. It is a good habit to carry||
1804|094|S|glucose tablets or gel to treat low blood sugar. If you don't||
1804|095|S|have these reliable forms of glucose, rapidly raise your blood||
1804|096|S|sugar by eating a quick source of sugar such as table sugar,||
1804|097|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
1804|098|S|doctor right away about the reaction and the use of this product.||
1804|099|S|To help prevent low blood sugar, eat meals on a regular schedule,||
1804|100|S|and do not skip meals. Check with your doctor or pharmacist to||
1804|101|S|find out what you should do if you miss a meal.||
1804|102|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1804|103|S|thirst/urination. If these symptoms occur, tell your doctor right||
1804|104|S|away. Your doctor may need to adjust your diabetes medication,||
1804|105|S|exercise program, or diet.||
1804|106|S|   A very serious allergic reaction to this drug is rare.||
1804|107|S|However, get medical help right away if you notice any symptoms||
1804|108|S|of a serious allergic reaction, including: rash, itching/swelling||
1804|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1804|110|S|breathing.||
1804|111|S|   This is not a complete list of possible side effects. If you||
1804|112|S|notice other effects not listed above, contact your doctor or||
1804|113|S|pharmacist.||
1804|114|S|   In the US -||
1804|115|S|   Call your doctor for medical advice about side effects. You||
1804|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1804|117|S|www.fda.gov/medwatch.||
1804|118|S|   In Canada - Call your doctor for medical advice about side||
1804|119|S|effects. You may report side effects to Health Canada at||
1804|120|S|1-866-234-2345.||
1804|121|B|||
1804|122|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1804|123|P|pharmacist if you are allergic to insulin glargine or||
1804|124|P|lixisenatide; or if you have any other allergies. This product||
1804|125|P|may contain inactive ingredients, which can cause allergic||
1804|126|P|reactions or other problems. Talk to your pharmacist for more||
1804|127|P|details.||
1804|128|P|   Do not use this medication when you have low blood sugar||
1804|129|P|(hypoglycemia).||
1804|130|P|   Before using this medication, tell your doctor or pharmacist||
1804|131|P|your medical history, especially of: kidney disease, liver||
1804|132|P|disease, disease of the pancreas (pancreatitis), gallbladder||
1804|133|P|disease, stomach/intestinal disorders (such as gastroparesis,||
1804|134|P|digestion problems).||
1804|135|P|   You may experience blurred vision, dizziness, or drowsiness||
1804|136|P|due to extremely low or high blood sugar. Do not drive, use||
1804|137|P|machinery, or do anything that needs alertness or clear vision||
1804|138|P|until you can do it safely.||
1804|139|P|   Limit alcohol while using this medication because it can||
1804|140|P|increase your risk of developing low blood sugar.||
1804|141|P|   It may be harder to control your blood sugar when your body is||
1804|142|P|stressed (such as due to fever, infection, injury, or surgery).||
1804|143|P|Consult your doctor because this may require a change in your||
1804|144|P|treatment plan, medications, or blood sugar testing.||
1804|145|P|   Before having surgery, tell your doctor or dentist about all||
1804|146|P|the products you use (including prescription drugs,||
1804|147|P|nonprescription drugs, and herbal products).||
1804|148|P|   Check your blood sugar before and after exercise. You may need||
1804|149|P|a snack beforehand.||
1804|150|P|   Older adults may be more sensitive to the side effects of this||
1804|151|P|drug, especially low blood sugar.||
1804|152|P|   During pregnancy, this medication should be used only when||
1804|153|P|clearly needed. Discuss the risks and benefits with your doctor.||
1804|154|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1804|155|P|your doctor for managing your blood sugar while pregnant. Your||
1804|156|P|doctor may change your diabetes treatment during your pregnancy||
1804|157|P|(such as diet and medications including insulin).||
1804|158|P|   Insulin glargine passes into breast milk. It is unknown if||
1804|159|P|lixisenatide passes into breast milk. Consult your doctor before||
1804|160|P|breastfeeding.||
1804|161|B|||
1804|162|I|DRUG INTERACTIONS:  See also How to Use section.||
1804|163|I|   Drug interactions may change how your medications work or||
1804|164|I|increase your risk for serious side effects. This document does||
1804|165|I|not contain all possible drug interactions. Keep a list of all||
1804|166|I|the products you use (including prescription/nonprescription||
1804|167|I|drugs and herbal products) and share it with your doctor and||
1804|168|I|pharmacist. Do not start, stop, or change the dosage of any||
1804|169|I|medicines without your doctor's approval.||
1804|170|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1804|171|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1804|172|I|heartbeat you would usually feel when your blood sugar falls too||
1804|173|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1804|174|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1804|175|I|   Many drugs can affect your blood sugar levels, making it more||
1804|176|I|difficult to control your blood sugar. Before you start, stop, or||
1804|177|I|change any medication, talk with your doctor or pharmacist about||
1804|178|I|how the medication may affect your blood sugar. Check your blood||
1804|179|I|sugar regularly as directed by your doctor. Tell your doctor||
1804|180|I|about the results and of any symptoms of high or low blood sugar.||
1804|181|I|(See also Side Effects section.) Your doctor may need to adjust||
1804|182|I|your diabetes medication, exercise program, or diet.||
1804|183|B|||
1804|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1804|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1804|186|O|poison control center right away. US residents can call||
1804|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1804|188|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
1804|189|O|sweating, loss of consciousness.||
1804|190|B|||
1804|191|N|NOTES:  Do not share this medication with others.||
1804|192|N|   Attend a diabetes education program to learn more about how to||
1804|193|N|manage your diabetes with medications, diet, exercise, and||
1804|194|N|regular medical exams.||
1804|195|N|   Learn the symptoms of high and low blood sugar and how to||
1804|196|N|treat low blood sugar. Check your blood sugar regularly as||
1804|197|N|directed and share the results with your doctor.||
1804|198|N|   Lab and/or medical tests (such as liver/kidney function,||
1804|199|N|fasting blood glucose, hemoglobin A1c) should be done while you||
1804|200|N|are using this medication. Keep all medical and lab appointments.||
1804|201|B|||
1804|202|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1804|203|D|next dose at the regular time. Do not double the dose to catch||
1804|204|D|up.||
1804|205|B|||
1804|206|R|STORAGE:  Store in the refrigerator before first use. Do not||
1804|207|R|freeze. Do not use this medication if it has been frozen. Keep||
1804|208|R|the medication in the original carton to protect from light.||
1804|209|R|After first use, store the medication at room temperature away||
1804|210|R|from heat and light. Discard the medication 28 days after first||
1804|211|R|use, even if some drug remains in the pen. Keep all medications||
1804|212|R|away from children and pets.||
1804|213|R|   Do not flush medications down the toilet or pour them into a||
1804|214|R|drain unless instructed to do so. Properly discard this product||
1804|215|R|when it is expired or no longer needed. Consult your pharmacist||
1804|216|R|or local waste disposal company.||
1804|217|B|||
1804|218|M|MEDICAL ALERT:  Your condition can cause complications in a||
1804|219|M|medical emergency. For information about enrolling in MedicAlert,||
1804|220|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1804|221|B|||
1804|222|A|Information last revised April 2025.||
1804|223|A|Copyright(c) 2025 First Databank, Inc.||
1804|224|B|||
1806|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1806|002|Z|does NOT have all possible information about this product. This||
1806|003|Z|information does not assure that this product is safe, effective,||
1806|004|Z|or appropriate for you. This information is not individual||
1806|005|Z|medical advice and does not substitute for the advice of your||
1806|006|Z|health care professional. Always ask your health care||
1806|007|Z|professional for complete information about this product and your||
1806|008|Z|specific health needs.||
1806|009|B|||
1806|010|T|RUCAPARIB - ORAL||
1806|011|F|(roo-KAP-a-rib)||
1806|012|B|||
1806|013|C|COMMON BRAND NAME(S): Rubraca||
1806|014|B|||
1806|015|U|USES:  This medication is used to treat certain cancers (such as||
1806|016|U|ovarian, fallopian tube, peritoneal, prostate cancer). It works||
1806|017|U|by slowing or stopping the growth of cancer cells.||
1806|018|B|||
1806|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1806|020|H|from your pharmacist before you start taking rucaparib and each||
1806|021|H|time you get a refill. If you have any questions, ask your doctor||
1806|022|H|or pharmacist.||
1806|023|H|   Take this medication by mouth with or without food as directed||
1806|024|H|by your doctor, usually twice daily (about 12 hours apart). The||
1806|025|H|dosage is based on your medical condition and response to||
1806|026|H|treatment.||
1806|027|H|   If you vomit after taking a dose, do not take another dose at||
1806|028|H|that time. Take your next dose at the regular time.||
1806|029|H|   Do not increase your dose or use this drug more often or for||
1806|030|H|longer than prescribed. Your condition will not improve any||
1806|031|H|faster, and your risk of side effects will increase.||
1806|032|H|   Since this drug can be absorbed through the skin and lungs and||
1806|033|H|may harm an unborn baby, women who are pregnant or who may become||
1806|034|H|pregnant should not handle this medication or breathe the dust||
1806|035|H|from the tablets.||
1806|036|B|||
1806|037|S|SIDE EFFECTS:  Nausea/vomiting, diarrhea, constipation,||
1806|038|S|stomach/abdominal pain, decreased appetite, metallic taste, or||
1806|039|S|dizziness may occur. If any of these effects last or get worse,||
1806|040|S|tell your doctor or pharmacist promptly.||
1806|041|S|   People using this medication may have serious side effects.||
1806|042|S|However, you have been prescribed this drug because your doctor||
1806|043|S|has judged that the benefit to you is greater than the risk of||
1806|044|S|side effects. Careful monitoring by your doctor may decrease your||
1806|045|S|risk.||
1806|046|S|   Tell your doctor right away if you have any serious side||
1806|047|S|effects, including: shortness of breath,||
1806|048|S|tingling/burning/blisters of the hands/feet.||
1806|049|S|   This medication decreases bone marrow function, an effect that||
1806|050|S|may lead to a low number of blood cells such as red cells, white||
1806|051|S|cells, and platelets. This effect can cause anemia, decrease your||
1806|052|S|body's ability to fight an infection, or cause easy||
1806|053|S|bruising/bleeding. This medication may also cause certain cancers||
1806|054|S|of the bone marrow (myelodysplastic syndrome, Acute Myeloid||
1806|055|S|Leukemia - AML). Tell your doctor right away if you develop any||
1806|056|S|of the following symptoms: unusual weight loss, unusual||
1806|057|S|tiredness, pale skin, signs of infection (such as sore throat||
1806|058|S|that doesn't go away, fever, chills), easy bruising/bleeding.||
1806|059|S|   Rucaparib can commonly cause a rash that is usually not||
1806|060|S|serious. However, you may not be able to tell it apart from a||
1806|061|S|rare rash that could be a sign of a severe reaction. Get medical||
1806|062|S|help right away if you develop any rash.||
1806|063|S|   A very serious allergic reaction to this drug is rare.||
1806|064|S|However, get medical help right away if you notice any symptoms||
1806|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1806|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1806|067|S|breathing.||
1806|068|S|   This is not a complete list of possible side effects. If you||
1806|069|S|notice other effects not listed above, contact your doctor or||
1806|070|S|pharmacist.||
1806|071|S|   In the US -||
1806|072|S|   Call your doctor for medical advice about side effects. You||
1806|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1806|074|S|www.fda.gov/medwatch.||
1806|075|S|   In Canada - Call your doctor for medical advice about side||
1806|076|S|effects. You may report side effects to Health Canada at||
1806|077|S|1-866-234-2345.||
1806|078|B|||
1806|079|P|PRECAUTIONS:  Before taking rucaparib, tell your doctor or||
1806|080|P|pharmacist if you are allergic to it; or if you have any other||
1806|081|P|allergies. This product may contain inactive ingredients, which||
1806|082|P|can cause allergic reactions or other problems. Talk to your||
1806|083|P|pharmacist for more details.||
1806|084|P|   Before using this medication, tell your doctor or pharmacist||
1806|085|P|your medical history.||
1806|086|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1806|087|P|can make you more dizzy. Do not drive, use machinery, or do||
1806|088|P|anything that needs alertness until you can do it safely. Limit||
1806|089|P|alcoholic beverages. Talk to your doctor if you are using||
1806|090|P|marijuana (cannabis).||
1806|091|P|   This medication may make you more sensitive to the sun. Limit||
1806|092|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1806|093|P|sunscreen and wear protective clothing when outdoors. Tell your||
1806|094|P|doctor right away if you get sunburned or have skin||
1806|095|P|blisters/redness.||
1806|096|P|   Before having surgery, tell your doctor or dentist about all||
1806|097|P|the products you use (including prescription drugs,||
1806|098|P|nonprescription drugs, and herbal products).||
1806|099|P|   Rucaparib can make you more likely to get infections or may||
1806|100|P|make current infections worse. Stay away from anyone who has an||
1806|101|P|infection that may easily spread (such as chickenpox, COVID-19,||
1806|102|P|measles, flu). Talk to your doctor if you have been exposed to an||
1806|103|P|infection or for more details.||
1806|104|P|   Tell your health care professional that you are using||
1806|105|P|rucaparib before having any immunizations/vaccinations. Avoid||
1806|106|P|contact with people who have recently received live vaccines||
1806|107|P|(such as flu vaccine inhaled through the nose).||
1806|108|P|   To lower the chance of getting cut, bruised, or injured, use||
1806|109|P|caution with sharp objects like razors and nail cutters, and||
1806|110|P|avoid activities such as contact sports.||
1806|111|P|   Since this drug can be absorbed through the skin and lungs and||
1806|112|P|may harm an unborn baby, women who are pregnant or who may become||
1806|113|P|pregnant should not handle this medication or breathe the dust||
1806|114|P|from the tablets.||
1806|115|P|   Tell your doctor if you are pregnant or plan to become||
1806|116|P|pregnant. You should not become pregnant while using rucaparib.||
1806|117|P|Rucaparib may harm an unborn baby. Your doctor should order a||
1806|118|P|pregnancy test before you start this medication. Women using this||
1806|119|P|medication should ask about reliable forms of birth control||
1806|120|P|during treatment and for 6 months after the last dose. Men using||
1806|121|P|this medication who have a partner that is pregnant or who can||
1806|122|P|become pregnant should ask about reliable forms of birth control||
1806|123|P|during treatment and for 3 months after the last dose. If you or||
1806|124|P|your partner becomes pregnant, talk to your doctor right away||
1806|125|P|about the risks and benefits of this medication.||
1806|126|P|   It is unknown if this drug passes into breast milk. Because of||
1806|127|P|the possible risk to the infant, breastfeeding is not recommended||
1806|128|P|while using this drug and for 2 weeks after the last dose.||
1806|129|P|Consult your doctor before breastfeeding.||
1806|130|B|||
1806|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1806|132|I|medications work or increase your risk for serious side effects.||
1806|133|I|This document does not contain all possible drug interactions.||
1806|134|I|Keep a list of all the products you use (including||
1806|135|I|prescription/nonprescription drugs and herbal products) and share||
1806|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
1806|137|I|the dosage of any medicines without your doctor's approval.||
1806|138|I|   A product that may interact with this drug is: fezolinetant.||
1806|139|B|||
1806|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1806|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1806|142|O|poison control center right away. US residents can call||
1806|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1806|144|B|||
1806|145|N|NOTES:  Do not share this medication with others.||
1806|146|N|   Lab and/or medical tests (such as complete blood count,||
1806|147|N|kidney/liver function, cholesterol levels) should be done before||
1806|148|N|you start taking this medication and while you are taking it.||
1806|149|N|Keep all medical and lab appointments. Consult your doctor for||
1806|150|N|more details.||
1806|151|B|||
1806|152|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1806|153|D|next dose at the regular time. Do not double the dose to catch||
1806|154|D|up.||
1806|155|B|||
1806|156|R|STORAGE:  Store at room temperature away from light and moisture.||
1806|157|R|Do not store in the bathroom. Keep all medications away from||
1806|158|R|children and pets.||
1806|159|R|   Do not flush medications down the toilet or pour them into a||
1806|160|R|drain unless instructed to do so. Properly discard this product||
1806|161|R|when it is expired or no longer needed. Consult your pharmacist||
1806|162|R|or local waste disposal company.||
1806|163|B|||
1806|164|M|MEDICAL ALERT:  Your condition can cause complications in a||
1806|165|M|medical emergency. For information about enrolling in MedicAlert,||
1806|166|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1806|167|B|||
1806|168|A|Information last revised May 2024.||
1806|169|A|Copyright(c) 2025 First Databank, Inc.||
1806|170|B|||
1807|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1807|002|Z|does NOT have all possible information about this product. This||
1807|003|Z|information does not assure that this product is safe, effective,||
1807|004|Z|or appropriate for you. This information is not individual||
1807|005|Z|medical advice and does not substitute for the advice of your||
1807|006|Z|health care professional. Always ask your health care||
1807|007|Z|professional for complete information about this product and your||
1807|008|Z|specific health needs.||
1807|009|B|||
1807|010|T|MORPHINE SPRINKLE CAPSULE - ORAL||
1807|011|F|(MOR-feen)||
1807|012|B|||
1807|013|W|WARNING:  Morphine has a risk for abuse and addiction, which can||
1807|014|W|lead to overdose and death. Morphine may also cause severe,||
1807|015|W|possibly fatal, breathing problems. To lower your risk, your||
1807|016|W|doctor should have you take the smallest dose of morphine that||
1807|017|W|works, and take it for the shortest possible time. See also How||
1807|018|W|to Use section for more information about addiction.||
1807|019|W|   Ask your doctor or pharmacist if you should have medication||
1807|020|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1807|021|W|Teach your family or household members about the signs of an||
1807|022|W|opioid overdose and how to treat it.||
1807|023|W|   The risk for severe breathing problems is higher when you||
1807|024|W|start this medication and after a dose increase, or if you take||
1807|025|W|the wrong dose/strength. Taking this medication with alcohol or||
1807|026|W|other drugs that can cause drowsiness or breathing problems may||
1807|027|W|cause very serious side effects, including death. Be sure you||
1807|028|W|know how to take morphine and what other drugs you should avoid||
1807|029|W|taking with it. See also Drug Interactions section. Get medical||
1807|030|W|help right away if any of these very serious side effects occur:||
1807|031|W|slow/shallow breathing, unusual lightheadedness, severe||
1807|032|W|drowsiness/dizziness, difficulty waking up.||
1807|033|W|   Keep this medicine in a safe place to prevent theft, misuse,||
1807|034|W|or abuse. If someone accidentally swallows this drug, get medical||
1807|035|W|help right away.||
1807|036|W|   Before using this medication, women of childbearing age should||
1807|037|W|talk with their doctor(s) about the risks and benefits. Tell your||
1807|038|W|doctor if you are pregnant or if you plan to become pregnant.||
1807|039|W|During pregnancy, this medication should be used only when||
1807|040|W|clearly needed. It may slightly increase the risk of birth||
1807|041|W|defects if used during the first two months of pregnancy. Also,||
1807|042|W|using it for a long time or in high doses near the expected||
1807|043|W|delivery date may harm the unborn baby. To lessen the risk, take||
1807|044|W|the smallest effective dose for the shortest possible time.||
1807|045|W|Babies born to mothers who use this drug for a long time may||
1807|046|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
1807|047|W|doctor right away if you notice any symptoms in your newborn baby||
1807|048|W|such as crying that doesn't stop, slow/shallow breathing,||
1807|049|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
1807|050|W|difficulty gaining weight.||
1807|051|B|||
1807|052|U|USES:  Morphine is used to help relieve severe pain. Morphine||
1807|053|U|belongs to a class of drugs known as opioid (narcotic)||
1807|054|U|analgesics. It works in the brain to change how your body feels||
1807|055|U|and responds to pain.||
1807|056|B|||
1807|057|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1807|058|H|from your pharmacist before you start taking morphine and each||
1807|059|H|time you get a refill. If you have any questions, ask your doctor||
1807|060|H|or pharmacist.||
1807|061|H|   Take this medication by mouth as directed by your doctor. You||
1807|062|H|may take this drug with or without food. If you have nausea, it||
1807|063|H|may help to take this drug with food. Ask your doctor or||
1807|064|H|pharmacist about other ways to decrease nausea (such as lying||
1807|065|H|down for 1 to 2 hours with as little head movement as possible).||
1807|066|H|   Swallow the capsules whole. If unable to swallow the capsule||
1807|067|H|whole, you may open the capsule and sprinkle the contents onto||
1807|068|H|soft food (such as applesauce, yogurt) or liquid. Swallow the||
1807|069|H|mixture right away without chewing. Do not prepare a supply ahead||
1807|070|H|of time. Do not cut, crush, chew, or dissolve the capsules.||
1807|071|H|   The dosage is based on your medical condition and response to||
1807|072|H|treatment. Do not increase your dose or use this drug more often||
1807|073|H|or for longer than prescribed, because your risk of side effects||
1807|074|H|may increase. Properly stop the medication when so directed.||
1807|075|H|   Pain medications work best if they are used when the first||
1807|076|H|signs of pain occur. If you wait until the pain has worsened, the||
1807|077|H|medication may not work as well.||
1807|078|H|   If you have ongoing pain (such as due to cancer), your doctor||
1807|079|H|may direct you to also take long-acting opioid medications. In||
1807|080|H|that case, this medication might be used for sudden||
1807|081|H|(breakthrough) pain only as needed. Other pain relievers (such as||
1807|082|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
1807|083|H|or pharmacist about using morphine safely with other drugs.||
1807|084|H|   Suddenly stopping this medication may cause withdrawal,||
1807|085|H|especially if you have used it for a long time or in high doses.||
1807|086|H|To prevent withdrawal, your doctor may lower your dose slowly.||
1807|087|H|Tell your doctor or pharmacist right away if you have any||
1807|088|H|withdrawal symptoms such as restlessness, mental/mood changes||
1807|089|H|(including anxiety, trouble sleeping, thoughts of suicide),||
1807|090|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
1807|091|H|aches, or sudden changes in behavior.||
1807|092|H|   When this medication is used for a long time, it may not work||
1807|093|H|as well. Talk with your doctor if this medication stops working||
1807|094|H|well.||
1807|095|H|   Though it helps many people, this medication may sometimes||
1807|096|H|cause addiction. This risk may be higher if you have a||
1807|097|H|mental/mood disorder or a substance use disorder (such as overuse||
1807|098|H|of or addiction to drugs/alcohol). Take this medication exactly||
1807|099|H|as prescribed to lower the risk of addiction. Ask your doctor or||
1807|100|H|pharmacist for more details.||
1807|101|H|   Tell your doctor if your pain does not get better or if it||
1807|102|H|gets worse, or if you have any new pain.||
1807|103|B|||
1807|104|S|SIDE EFFECTS:  See also Warning section.||
1807|105|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
1807|106|S|drowsiness, or sweating may occur. Some of these side effects may||
1807|107|S|decrease after you have been using this medication for a while.||
1807|108|S|If any of these effects last or get worse, tell your doctor or||
1807|109|S|pharmacist promptly.||
1807|110|S|   To prevent constipation, eat dietary fiber, drink enough||
1807|111|S|water, and exercise. You may also need to take a laxative. Ask||
1807|112|S|your pharmacist which type of laxative is right for you.||
1807|113|S|   To reduce the risk of dizziness and lightheadedness, get up||
1807|114|S|slowly when rising from a sitting or lying position.||
1807|115|S|   Remember that this medication has been prescribed because your||
1807|116|S|doctor has judged that the benefit to you is greater than the||
1807|117|S|risk of side effects. Many people using this medication do not||
1807|118|S|have serious side effects.||
1807|119|S|   Tell your doctor right away if you have any serious side||
1807|120|S|effects, including: interrupted breathing during sleep (sleep||
1807|121|S|apnea), mental/mood changes (such as agitation, confusion,||
1807|122|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
1807|123|S|signs of your adrenal glands not working well (such as loss of||
1807|124|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
1807|125|S|   Get medical help right away if you have any very serious side||
1807|126|S|effects, including: fainting, seizure, slow/shallow breathing,||
1807|127|S|unusual drowsiness/difficulty waking up.||
1807|128|S|   A very serious allergic reaction to this drug is rare.||
1807|129|S|However, get medical help right away if you notice any symptoms||
1807|130|S|of a serious allergic reaction, including: rash, itching/swelling||
1807|131|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1807|132|S|breathing.||
1807|133|S|   This is not a complete list of possible side effects. If you||
1807|134|S|notice other effects not listed above, contact your doctor or||
1807|135|S|pharmacist.||
1807|136|S|   In the US -||
1807|137|S|   Call your doctor for medical advice about side effects. You||
1807|138|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1807|139|S|www.fda.gov/medwatch.||
1807|140|S|   In Canada - Call your doctor for medical advice about side||
1807|141|S|effects. You may report side effects to Health Canada at||
1807|142|S|1-866-234-2345.||
1807|143|B|||
1807|144|P|PRECAUTIONS:  Before taking morphine, tell your doctor or||
1807|145|P|pharmacist if you are allergic to it; or to other opioid pain||
1807|146|P|medications (such as codeine); or if you have any other||
1807|147|P|allergies. This product may contain inactive ingredients, which||
1807|148|P|can cause allergic reactions or other problems. Talk to your||
1807|149|P|pharmacist for more details.||
1807|150|P|   Before using this medication, tell your doctor or pharmacist||
1807|151|P|your medical history, especially of: brain disorders (such as||
1807|152|P|head injury, tumor, seizures), breathing problems (such as||
1807|153|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1807|154|P|gallbladder disease, kidney disease, liver disease, mental/mood||
1807|155|P|disorders (such as confusion, depression, thoughts of suicide),||
1807|156|P|personal or family history of a substance use disorder (such as||
1807|157|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
1807|158|P|problems (such as blockage, constipation, diarrhea due to||
1807|159|P|infection, paralytic ileus), disease of the pancreas||
1807|160|P|(pancreatitis), difficulty urinating (such as due to enlarged||
1807|161|P|prostate).||
1807|162|P|   This drug may make you dizzy or drowsy. Do not drive, use||
1807|163|P|machinery, or do anything that needs alertness until you can do||
1807|164|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1807|165|P|are using marijuana (cannabis).||
1807|166|P|   Before having surgery, tell your doctor or dentist about all||
1807|167|P|the products you use (including prescription drugs,||
1807|168|P|nonprescription drugs, and herbal products).||
1807|169|P|   Older adults may be more sensitive to the side effects of this||
1807|170|P|drug, especially confusion, dizziness, drowsiness, and||
1807|171|P|slow/shallow breathing.||
1807|172|P|   During pregnancy, this medication should be used only when||
1807|173|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1807|174|P|benefits with your doctor. (See also Warning section.)||
1807|175|P|   This drug passes into breast milk and may have undesirable||
1807|176|P|effects on a nursing infant. Tell the doctor right away if your||
1807|177|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
1807|178|P|breathing. Consult your doctor before breastfeeding.||
1807|179|B|||
1807|180|I|DRUG INTERACTIONS:  See also Warning section.||
1807|181|I|   Drug interactions may change how your medications work or||
1807|182|I|increase your risk for serious side effects. This document does||
1807|183|I|not contain all possible drug interactions. Keep a list of all||
1807|184|I|the products you use (including prescription/nonprescription||
1807|185|I|drugs and herbal products) and share it with your doctor and||
1807|186|I|pharmacist. Do not start, stop, or change the dosage of any||
1807|187|I|medicines without your doctor's approval.||
1807|188|I|   Some products that may interact with this drug are: certain||
1807|189|I|pain medications (mixed opioid agonist/antagonists such as||
1807|190|I|pentazocine, nalbuphine, butorphanol), naltrexone, samidorphan.||
1807|191|I|   The risk of serious side effects (such as slow/shallow||
1807|192|I|breathing, severe drowsiness/dizziness) may be increased if this||
1807|193|I|medication is taken with other products that may also cause||
1807|194|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1807|195|I|if you are taking other products such as other opioid pain or||
1807|196|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1807|197|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1807|198|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1807|199|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1807|200|I|cetirizine, diphenhydramine).||
1807|201|I|   Check the labels on all your medicines (such as allergy or||
1807|202|I|cough-and-cold products) because they may contain ingredients||
1807|203|I|that cause drowsiness. Ask your pharmacist about using those||
1807|204|I|products safely.||
1807|205|I|   This medication may interfere with certain lab tests (such as||
1807|206|I|amylase/lipase levels), possibly causing false test results. Make||
1807|207|I|sure lab personnel and all your doctors know you use this drug.||
1807|208|B|||
1807|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1807|210|O|as passing out or trouble breathing, give them naloxone or||
1807|211|O|nalmefene if available, then call 911. If the person is awake and||
1807|212|O|has no symptoms, call a poison control center right away. US||
1807|213|O|residents can call 1-800-222-1222. Canada residents can call||
1807|214|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
1807|215|O|breathing, slow heartbeat, coma.||
1807|216|B|||
1807|217|N|NOTES:  Do not share this medication with others. Sharing it is||
1807|218|N|against the law.||
1807|219|N|   This medication has been prescribed for your current condition||
1807|220|N|only. Do not use it later for another condition unless your||
1807|221|N|doctor tells you to. A different medication may be necessary in||
1807|222|N|that case.||
1807|223|B|||
1807|224|D|MISSED DOSE:  If you are taking this medication on a regular||
1807|225|D|schedule and miss a dose, take it as soon as you remember. If it||
1807|226|D|is near the time of the next dose, skip the missed dose. Take||
1807|227|D|your next dose at the regular time. Do not double the dose to||
1807|228|D|catch up.||
1807|229|B|||
1807|230|R|STORAGE:  Store at room temperature away from light and moisture.||
1807|231|R|Do not store in the bathroom. Keep all medications away from||
1807|232|R|children and pets.||
1807|233|R|   Do not flush medications down the toilet or pour them into a||
1807|234|R|drain unless instructed to do so. Properly discard this product||
1807|235|R|when it is expired or no longer needed. Consult your pharmacist||
1807|236|R|or local waste disposal company.||
1807|237|B|||
1807|238|A|Information last revised November 2025.||
1807|239|A|Copyright(c) 2025 First Databank, Inc.||
1807|240|B|||
1808|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1808|002|Z|does NOT have all possible information about this product. This||
1808|003|Z|information does not assure that this product is safe, effective,||
1808|004|Z|or appropriate for you. This information is not individual||
1808|005|Z|medical advice and does not substitute for the advice of your||
1808|006|Z|health care professional. Always ask your health care||
1808|007|Z|professional for complete information about this product and your||
1808|008|Z|specific health needs.||
1808|009|B|||
1808|010|T|CRISABOROLE - TOPICAL||
1808|011|F|(KRIS-a-BOR-ole)||
1808|012|B|||
1808|013|C|COMMON BRAND NAME(S): Eucrisa||
1808|014|B|||
1808|015|U|USES:  This medication is used to treat eczema. It reduces||
1808|016|U|swelling, redness, and itching on the skin.||
1808|017|B|||
1808|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1808|019|H|from your pharmacist before you start using crisaborole and each||
1808|020|H|time you get a refill. If you have any questions, ask your doctor||
1808|021|H|or pharmacist.||
1808|022|H|   This medication is for use on the skin only. Avoid getting||
1808|023|H|this medication in the eyes, mouth, or vagina. If this occurs,||
1808|024|H|rinse with plenty of water.||
1808|025|H|   Wash and dry your hands before applying the medication, then||
1808|026|H|clean and dry the affected area. Apply a thin film of the||
1808|027|H|medication to the affected area and gently rub in as directed by||
1808|028|H|your doctor, usually 2 times daily. Your doctor may instruct you||
1808|029|H|to reduce the number of times you use this medication once your||
1808|030|H|eczema clears up. Consult your doctor for details.||
1808|031|H|   After applying the medication, wash and dry your hands, unless||
1808|032|H|you are using this medication to treat the hands.||
1808|033|H|   Use this medication regularly to get the most benefit from it.||
1808|034|H|To help you remember, use it at the same time(s) each day.||
1808|035|H|   Tell your doctor if your condition lasts or gets worse.||
1808|036|B|||
1808|037|S|SIDE EFFECTS:  Burning or stinging at the application site may||
1808|038|S|occur. If either of these effects lasts or gets worse, tell your||
1808|039|S|doctor or pharmacist promptly.||
1808|040|S|   Remember that this medication has been prescribed because your||
1808|041|S|doctor has judged that the benefit to you is greater than the||
1808|042|S|risk of side effects. Many people using this medication do not||
1808|043|S|have serious side effects.||
1808|044|S|   A very serious allergic reaction to this drug is rare.||
1808|045|S|However, get medical help right away if you notice any symptoms||
1808|046|S|of a serious allergic reaction, including: rash, itching/swelling||
1808|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1808|048|S|breathing.||
1808|049|S|   This is not a complete list of possible side effects. If you||
1808|050|S|notice other effects not listed above, contact your doctor or||
1808|051|S|pharmacist.||
1808|052|S|   In the US -||
1808|053|S|   Call your doctor for medical advice about side effects. You||
1808|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1808|055|S|www.fda.gov/medwatch.||
1808|056|S|   In Canada - Call your doctor for medical advice about side||
1808|057|S|effects. You may report side effects to Health Canada at||
1808|058|S|1-866-234-2345.||
1808|059|B|||
1808|060|P|PRECAUTIONS:  Before using crisaborole, tell your doctor or||
1808|061|P|pharmacist if you are allergic to it; or if you have any other||
1808|062|P|allergies. This product may contain inactive ingredients, which||
1808|063|P|can cause allergic reactions or other problems. Talk to your||
1808|064|P|pharmacist for more details.||
1808|065|P|   Before using this medication, tell your doctor or pharmacist||
1808|066|P|your medical history.||
1808|067|P|   Before having surgery, tell your doctor or dentist about all||
1808|068|P|the products you use (including prescription drugs,||
1808|069|P|nonprescription drugs, and herbal products).||
1808|070|P|   During pregnancy, this medication should be used only when||
1808|071|P|clearly needed. Discuss the risks and benefits with your doctor.||
1808|072|P|   It is unknown if this medication passes into breast milk.||
1808|073|P|Consult your doctor before breastfeeding.||
1808|074|B|||
1808|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1808|076|I|medications work or increase your risk for serious side effects.||
1808|077|I|This document does not contain all possible drug interactions.||
1808|078|I|Keep a list of all the products you use (including||
1808|079|I|prescription/nonprescription drugs and herbal products) and share||
1808|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
1808|081|I|the dosage of any medicines without your doctor's approval.||
1808|082|B|||
1808|083|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1808|084|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1808|085|O|poison control center right away. US residents can call||
1808|086|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1808|087|B|||
1808|088|N|NOTES:  Do not share this medication with others.||
1808|089|B|||
1808|090|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1808|091|D|If it is near the time of the next dose, skip the missed dose.||
1808|092|D|Use your next dose at the regular time. Do not double the dose to||
1808|093|D|catch up.||
1808|094|B|||
1808|095|R|STORAGE:  Store at room temperature. Keep all medications away||
1808|096|R|from children and pets.||
1808|097|R|   Do not flush medications down the toilet or pour them into a||
1808|098|R|drain unless instructed to do so. Properly discard this product||
1808|099|R|when it is expired or no longer needed. Consult your pharmacist||
1808|100|R|or local waste disposal company.||
1808|101|B|||
1808|102|A|Information last revised May 2024.||
1808|103|A|Copyright(c) 2025 First Databank, Inc.||
1808|104|B|||
1809|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1809|002|Z|does NOT have all possible information about this product. This||
1809|003|Z|information does not assure that this product is safe, effective,||
1809|004|Z|or appropriate for you. This information is not individual||
1809|005|Z|medical advice and does not substitute for the advice of your||
1809|006|Z|health care professional. Always ask your health care||
1809|007|Z|professional for complete information about this product and your||
1809|008|Z|specific health needs.||
1809|009|B|||
1809|010|T|BILASTINE - ORAL||
1809|011|B|||
1809|012|U|USES:  This medication is an antihistamine used to relieve||
1809|013|U|allergy symptoms such as watery eyes, runny nose, itching||
1809|014|U|eyes/nose, and sneezing. It is also used to relieve itching and||
1809|015|U|hives. It works by blocking a certain natural substance||
1809|016|U|(histamine) that your body makes during an allergic reaction.||
1809|017|U|   Bilastine does not prevent hives or prevent/treat a serious||
1809|018|U|allergic reaction (such as anaphylaxis). If your doctor has||
1809|019|U|prescribed epinephrine to treat allergic reactions, always carry||
1809|020|U|your epinephrine injector with you. Do not use bilastine in place||
1809|021|U|of your epinephrine.||
1809|022|B|||
1809|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1809|024|H|from your pharmacist before you start taking bilastine and each||
1809|025|H|time you get a refill. If you have any questions, ask your doctor||
1809|026|H|or pharmacist.||
1809|027|H|   Take this medication by mouth on an empty stomach (at least 1||
1809|028|H|hour before or 2 hours after food, grapefruit juice, or other||
1809|029|H|fruit juices) as directed by your doctor, usually once a day.||
1809|030|H|Taking this medication with food, grapefruit juice, or other||
1809|031|H|fruit juices may make this medication work less well.||
1809|032|H|   If you are using the liquid form of this medication, carefully||
1809|033|H|measure the dose using a special measuring device/spoon. Do not||
1809|034|H|use a household spoon because you may not get the correct dose.||
1809|035|H|   Use this medication regularly to get the most benefit from it.||
1809|036|H|To help you remember, take it at the same time each day. Do not||
1809|037|H|increase your dose or take this drug more often than directed.||
1809|038|H|   Tell your doctor if your condition does not get better or if||
1809|039|H|it gets worse.||
1809|040|B|||
1809|041|S|SIDE EFFECTS:  This drug usually has no side effects. If you have||
1809|042|S|any unusual effects, contact your doctor or pharmacist promptly.||
1809|043|S|   Remember that this medication has been prescribed because your||
1809|044|S|doctor has judged that the benefit to you is greater than the||
1809|045|S|risk of side effects. Many people using this medication do not||
1809|046|S|have serious side effects.||
1809|047|S|   Get medical help right away if you have any very serious side||
1809|048|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1809|049|S|fainting.||
1809|050|S|   A very serious allergic reaction to this drug is rare.||
1809|051|S|However, get medical help right away if you notice any symptoms||
1809|052|S|of a serious allergic reaction, including: rash, itching/swelling||
1809|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1809|054|S|breathing.||
1809|055|S|   This is not a complete list of possible side effects. If you||
1809|056|S|notice other effects not listed above, contact your doctor or||
1809|057|S|pharmacist.||
1809|058|S|   In the US -||
1809|059|S|   Call your doctor for medical advice about side effects. You||
1809|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1809|061|S|www.fda.gov/medwatch.||
1809|062|S|   In Canada - Call your doctor for medical advice about side||
1809|063|S|effects. You may report side effects to Health Canada at||
1809|064|S|1-866-234-2345.||
1809|065|B|||
1809|066|P|PRECAUTIONS:  Before taking bilastine, tell your doctor or||
1809|067|P|pharmacist if you are allergic to it; or if you have any other||
1809|068|P|allergies. This product may contain inactive ingredients, which||
1809|069|P|can cause allergic reactions or other problems. Talk to your||
1809|070|P|pharmacist for more details.||
1809|071|P|   Before using this medication, tell your doctor or pharmacist||
1809|072|P|your medical history, especially of: kidney disease.||
1809|073|P|   This drug may rarely make you drowsy. Alcohol or marijuana||
1809|074|P|(cannabis) can make you more drowsy. Do not drive, use machinery,||
1809|075|P|or do anything that needs alertness until you can do it safely.||
1809|076|P|Limit alcoholic beverages. Talk to your doctor if you are using||
1809|077|P|marijuana (cannabis).||
1809|078|P|   Bilastine may cause a condition that affects the heart rhythm||
1809|079|P|(QT prolongation). QT prolongation can rarely cause serious||
1809|080|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1809|081|P|as severe dizziness, fainting) that need medical attention right||
1809|082|P|away.||
1809|083|P|   The risk of QT prolongation may be increased if you have||
1809|084|P|certain medical conditions or are taking other drugs that may||
1809|085|P|cause QT prolongation. Before using bilastine, tell your doctor||
1809|086|P|or pharmacist of all the drugs you take and if you have any of||
1809|087|P|the following conditions: certain heart problems (heart failure,||
1809|088|P|slow heartbeat, QT prolongation in the EKG), family history of||
1809|089|P|certain heart problems (QT prolongation in the EKG, sudden||
1809|090|P|cardiac death).||
1809|091|P|   Low levels of potassium or magnesium in the blood may also||
1809|092|P|increase your risk of QT prolongation. This risk may increase if||
1809|093|P|you use certain drugs (such as diuretics/"water pills") or if you||
1809|094|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1809|095|P|Talk to your doctor about using bilastine safely.||
1809|096|P|   Liquid products may contain sugar and/or aspartame. Liquid||
1809|097|P|products may also contain alcohol. Caution is advised if you have||
1809|098|P|diabetes, liver disease, phenylketonuria (PKU), or any other||
1809|099|P|condition that requires you to limit/avoid these substances in||
1809|100|P|your diet. Ask your doctor or pharmacist about using this product||
1809|101|P|safely.||
1809|102|P|   Before having surgery, tell your doctor or dentist about all||
1809|103|P|the products you use (including prescription drugs,||
1809|104|P|nonprescription drugs, and herbal products).||
1809|105|P|   Older adults may be more sensitive to the side effects of this||
1809|106|P|drug, especially QT prolongation (see above).||
1809|107|P|   During pregnancy, this medication should be used only when||
1809|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
1809|109|P|   It is unknown if this medication passes into breast milk.||
1809|110|P|Consult your doctor before breastfeeding.||
1809|111|B|||
1809|112|I|DRUG INTERACTIONS:  See also How to Use section.||
1809|113|I|   Drug interactions may change how your medications work or||
1809|114|I|increase your risk for serious side effects. This document does||
1809|115|I|not contain all possible drug interactions. Keep a list of all||
1809|116|I|the products you use (including prescription/nonprescription||
1809|117|I|drugs and herbal products) and share it with your doctor and||
1809|118|I|pharmacist. Do not start, stop, or change the dosage of any||
1809|119|I|medicines without your doctor's approval.||
1809|120|I|   This medication may interfere with certain lab tests||
1809|121|I|(including allergy skin testing), possibly causing false test||
1809|122|I|results. Make sure lab personnel and all your doctors know you||
1809|123|I|use this drug.||
1809|124|B|||
1809|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1809|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1809|127|O|poison control center right away. US residents can call||
1809|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1809|129|O|Symptoms of overdose may include: severe drowsiness.||
1809|130|B|||
1809|131|N|NOTES:  Do not share this medication with others.||
1809|132|B|||
1809|133|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1809|134|D|remember. If it is near the time of the next dose, skip the||
1809|135|D|missed dose. Take your next dose at the regular time. Do not||
1809|136|D|double the dose to catch up.||
1809|137|B|||
1809|138|R|STORAGE:  Store at room temperature away from light and moisture.||
1809|139|R|Do not store in the bathroom. Keep all medications away from||
1809|140|R|children and pets.||
1809|141|R|   Do not flush medications down the toilet or pour them into a||
1809|142|R|drain unless instructed to do so. Properly discard this product||
1809|143|R|when it is expired or no longer needed. Consult your pharmacist||
1809|144|R|or local waste disposal company.||
1809|145|B|||
1809|146|A|Information last revised May 2024.||
1809|147|A|Copyright(c) 2025 First Databank, Inc.||
1809|148|B|||
1810|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1810|002|Z|does NOT have all possible information about this product. This||
1810|003|Z|information does not assure that this product is safe, effective,||
1810|004|Z|or appropriate for you. This information is not individual||
1810|005|Z|medical advice and does not substitute for the advice of your||
1810|006|Z|health care professional. Always ask your health care||
1810|007|Z|professional for complete information about this product and your||
1810|008|Z|specific health needs.||
1810|009|B|||
1810|010|T|RUPATADINE - ORAL||
1810|011|B|||
1810|012|U|USES:  Rupatadine is an antihistamine used to relieve allergy||
1810|013|U|symptoms such as watery eyes, runny nose, itching eyes/nose, and||
1810|014|U|sneezing. It is also used to relieve itching and hives. It works||
1810|015|U|by blocking a certain natural substance (histamine) that your||
1810|016|U|body makes during an allergic reaction.||
1810|017|U|   Rupatadine does not prevent hives or prevent/treat a serious||
1810|018|U|allergic reaction (such as anaphylaxis). If your doctor has||
1810|019|U|prescribed epinephrine to treat allergic reactions, always carry||
1810|020|U|your epinephrine injector with you. Do not use rupatadine in||
1810|021|U|place of your epinephrine.||
1810|022|B|||
1810|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1810|024|H|from your pharmacist before you start taking rupatadine and each||
1810|025|H|time you get a refill. If you have any questions, ask your doctor||
1810|026|H|or pharmacist.||
1810|027|H|   Take this medication by mouth with or without food as directed||
1810|028|H|by your doctor, usually once daily. Children's dosage is based on||
1810|029|H|weight and age.||
1810|030|H|   If you are using the liquid form of this medication, carefully||
1810|031|H|measure the dose using a special measuring device/spoon. Do not||
1810|032|H|use a household spoon because you may not get the correct dose.||
1810|033|H|   Use this medication regularly to get the most benefit from it.||
1810|034|H|To help you remember, take it at the same time each day.||
1810|035|H|   Do not increase your dose or use this drug more often or for||
1810|036|H|longer than prescribed. Your condition will not improve any||
1810|037|H|faster, and your risk of side effects will increase.||
1810|038|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1810|039|H|using this medication unless your doctor or pharmacist says you||
1810|040|H|may do so safely. Grapefruit can increase the chance of side||
1810|041|H|effects with this medicine. Ask your doctor or pharmacist for||
1810|042|H|more details.||
1810|043|H|   Tell your doctor if your condition does not get better or if||
1810|044|H|it gets worse.||
1810|045|B|||
1810|046|S|SIDE EFFECTS:  Drowsiness or headache may occur. If either of||
1810|047|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1810|048|S|promptly.||
1810|049|S|   Remember that this medication has been prescribed because your||
1810|050|S|doctor has judged that the benefit to you is greater than the||
1810|051|S|risk of side effects. Many people using this medication do not||
1810|052|S|have serious side effects.||
1810|053|S|   Get medical help right away if you have any very serious side||
1810|054|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1810|055|S|fainting.||
1810|056|S|   A very serious allergic reaction to this drug is rare.||
1810|057|S|However, get medical help right away if you notice any symptoms||
1810|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1810|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1810|060|S|breathing.||
1810|061|S|   This is not a complete list of possible side effects. If you||
1810|062|S|notice other effects not listed above, contact your doctor or||
1810|063|S|pharmacist.||
1810|064|S|   In the US -||
1810|065|S|   Call your doctor for medical advice about side effects. You||
1810|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1810|067|S|www.fda.gov/medwatch.||
1810|068|S|   In Canada - Call your doctor for medical advice about side||
1810|069|S|effects. You may report side effects to Health Canada at||
1810|070|S|1-866-234-2345.||
1810|071|B|||
1810|072|P|PRECAUTIONS:  Before taking rupatadine, tell your doctor or||
1810|073|P|pharmacist if you are allergic to it; or if you have any other||
1810|074|P|allergies. This product may contain inactive ingredients, which||
1810|075|P|can cause allergic reactions or other problems. Talk to your||
1810|076|P|pharmacist for more details.||
1810|077|P|   Before using this medication, tell your doctor or pharmacist||
1810|078|P|your medical history, especially of: certain genetic enzyme||
1810|079|P|problems (galactose/fructose intolerance, lactase/sucrase||
1810|080|P|deficiency, glucose-galactose malabsorption).||
1810|081|P|   Rupatadine may cause a condition that affects the heart rhythm||
1810|082|P|(QT prolongation). QT prolongation can rarely cause serious||
1810|083|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1810|084|P|as severe dizziness, fainting) that need medical attention right||
1810|085|P|away.||
1810|086|P|   The risk of QT prolongation may be increased if you have||
1810|087|P|certain medical conditions or are taking other drugs that may||
1810|088|P|cause QT prolongation. Before using rupatadine, tell your doctor||
1810|089|P|or pharmacist of all the drugs you take and if you have any of||
1810|090|P|the following conditions: certain heart problems (heart failure,||
1810|091|P|slow heartbeat, QT prolongation in the EKG), family history of||
1810|092|P|certain heart problems (QT prolongation in the EKG, sudden||
1810|093|P|cardiac death).||
1810|094|P|   Low levels of potassium or magnesium in the blood may also||
1810|095|P|increase your risk of QT prolongation. This risk may increase if||
1810|096|P|you use certain drugs (such as diuretics "water pills") or if you||
1810|097|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1810|098|P|Talk to your doctor about using rupatadine safely.||
1810|099|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
1810|100|P|can make you more drowsy. Do not drive, use machinery, or do||
1810|101|P|anything that needs alertness until you can do it safely. Limit||
1810|102|P|alcoholic beverages. Talk to your doctor if you are using||
1810|103|P|marijuana (cannabis).||
1810|104|P|   Before having surgery, tell your doctor or dentist about all||
1810|105|P|the products you use (including prescription drugs,||
1810|106|P|nonprescription drugs, and herbal products).||
1810|107|P|   Older adults may be more sensitive to the side effects of this||
1810|108|P|drug, especially QT prolongation (see above).||
1810|109|P|   During pregnancy, this medication should be used only when||
1810|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
1810|111|P|   It is unknown if this medication passes into breast milk.||
1810|112|P|Consult your doctor before breastfeeding.||
1810|113|B|||
1810|114|I|DRUG INTERACTIONS:  See also How to Use section.||
1810|115|I|   Drug interactions may change how your medications work or||
1810|116|I|increase your risk for serious side effects. This document does||
1810|117|I|not contain all possible drug interactions. Keep a list of all||
1810|118|I|the products you use (including prescription/nonprescription||
1810|119|I|drugs and herbal products) and share it with your doctor and||
1810|120|I|pharmacist. Do not start, stop, or change the dosage of any||
1810|121|I|medicines without your doctor's approval.||
1810|122|I|   Other medications can affect the removal of rupatadine from||
1810|123|I|your body, which may affect how rupatadine works. Examples||
1810|124|I|include azole antifungals (such as ketoconazole), macrolide||
1810|125|I|antibiotics (such as erythromycin), rifamycins (such as||
1810|126|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
1810|127|I|as carbamazepine, phenytoin), among others.||
1810|128|I|   This medication may interfere with certain lab tests (such as||
1810|129|I|allergy skin testing), possibly causing false test results. Make||
1810|130|I|sure lab personnel and all your doctors know you use this drug.||
1810|131|B|||
1810|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1810|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1810|134|O|poison control center right away. US residents can call||
1810|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1810|136|B|||
1810|137|N|NOTES:  Do not share this medication with others.||
1810|138|B|||
1810|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1810|140|D|remember. If it is near the time of the next dose, skip the||
1810|141|D|missed dose. Take your next dose at the regular time. Do not||
1810|142|D|double the dose to catch up.||
1810|143|B|||
1810|144|R|STORAGE:  Store at room temperature away from light and moisture.||
1810|145|R|Do not store in the bathroom. Keep all medications away from||
1810|146|R|children and pets.||
1810|147|R|   Do not flush medications down the toilet or pour them into a||
1810|148|R|drain unless instructed to do so. Properly discard this product||
1810|149|R|when it is expired or no longer needed. Consult your pharmacist||
1810|150|R|or local waste disposal company.||
1810|151|B|||
1810|152|A|Information last revised August 2024.||
1810|153|A|Copyright(c) 2025 First Databank, Inc.||
1810|154|B|||
1811|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1811|002|Z|does NOT have all possible information about this product. This||
1811|003|Z|information does not assure that this product is safe, effective,||
1811|004|Z|or appropriate for you. This information is not individual||
1811|005|Z|medical advice and does not substitute for the advice of your||
1811|006|Z|health care professional. Always ask your health care||
1811|007|Z|professional for complete information about this product and your||
1811|008|Z|specific health needs.||
1811|009|B|||
1811|010|T|PLECANATIDE - ORAL||
1811|011|F|(ple-KAN-a-tide)||
1811|012|B|||
1811|013|C|COMMON BRAND NAME(S): Trulance||
1811|014|B|||
1811|015|W|WARNING:  This medication must not be used by children younger||
1811|016|W|than 6 years. It is not recommended for use in children 6 to less||
1811|017|W|than 18 years due to the risk for harm (especially serious||
1811|018|W|dehydration). Talk to your doctor for details.||
1811|019|B|||
1811|020|U|USES:  See also Warning section.||
1811|021|U|   Plecanatide is used to treat certain types of bowel problems||
1811|022|U|(chronic idiopathic constipation, irritable bowel syndrome with||
1811|023|U|constipation). It works by increasing fluid in your intestines||
1811|024|U|and helping speed up movement of food through the gut.||
1811|025|U|Plecanatide may improve stool texture and lessen symptoms such as||
1811|026|U|straining and feelings of incomplete bowel movements.||
1811|027|B|||
1811|028|H|HOW TO USE:  Read the Medication Guide provided by your||
1811|029|H|pharmacist before you start taking plecanatide and each time you||
1811|030|H|get a refill. If you have any questions, ask your doctor or||
1811|031|H|pharmacist.||
1811|032|H|   Take this medication by mouth with or without food as directed||
1811|033|H|by your doctor, usually once daily.||
1811|034|H|   If you have trouble swallowing the tablet, you may crush the||
1811|035|H|tablet and mix the powder into a teaspoonful of room-temperature||
1811|036|H|applesauce. Swallow the mixture right away. Do not save the||
1811|037|H|mixture for future use.||
1811|038|H|   You may also place the tablet into a cup with an ounce (30||
1811|039|H|milliliters) of room-temperature water. Swirl the mixture for at||
1811|040|H|least 10 seconds and then drink right away. If you see any part||
1811|041|H|of the tablet left in the cup, add another ounce (30 milliliters)||
1811|042|H|of water to the cup, swirl for 10 seconds and drink right away to||
1811|043|H|get your whole dose. The water mixture may also be given through||
1811|044|H|a tube into the stomach (nasogastric or gastric tube). If you are||
1811|045|H|giving this medication through a tube, ask your health care||
1811|046|H|professional for detailed instructions on how to give it.||
1811|047|H|   Use this medication regularly to get the most benefit from it.||
1811|048|H|To help you remember, take it at the same time each day.||
1811|049|H|   Do not increase your dose or use this drug more often or for||
1811|050|H|longer than prescribed. Your condition will not improve any||
1811|051|H|faster, and your risk of side effects will increase.||
1811|052|H|   Tell your doctor if you do not get better or if you get worse.||
1811|053|B|||
1811|054|S|SIDE EFFECTS:  Diarrhea may occur. If this effect lasts or gets||
1811|055|S|worse, tell your doctor or pharmacist promptly.||
1811|056|S|   Remember that this medication has been prescribed because your||
1811|057|S|doctor has judged that the benefit to you is greater than the||
1811|058|S|risk of side effects. Many people using this medication do not||
1811|059|S|have serious side effects.||
1811|060|S|   Stop taking this medication and tell your doctor right away if||
1811|061|S|you have any serious side effects, including: severe diarrhea.||
1811|062|S|   A very serious allergic reaction to this drug is rare.||
1811|063|S|However, get medical help right away if you notice any symptoms||
1811|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1811|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1811|066|S|breathing.||
1811|067|S|   This is not a complete list of possible side effects. If you||
1811|068|S|notice other effects not listed above, contact your doctor or||
1811|069|S|pharmacist.||
1811|070|S|   In the US -||
1811|071|S|   Call your doctor for medical advice about side effects. You||
1811|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1811|073|S|www.fda.gov/medwatch.||
1811|074|S|   In Canada - Call your doctor for medical advice about side||
1811|075|S|effects. You may report side effects to Health Canada at||
1811|076|S|1-866-234-2345.||
1811|077|B|||
1811|078|P|PRECAUTIONS:  Before taking plecanatide, tell your doctor or||
1811|079|P|pharmacist if you are allergic to it; or if you have any other||
1811|080|P|allergies. This product may contain inactive ingredients, which||
1811|081|P|can cause allergic reactions or other problems. Talk to your||
1811|082|P|pharmacist for more details.||
1811|083|P|   Before using this medication, tell your doctor or pharmacist||
1811|084|P|your medical history, especially of: stomach/intestinal blockage.||
1811|085|P|   Before having surgery, tell your doctor or dentist about all||
1811|086|P|the products you use (including prescription drugs,||
1811|087|P|nonprescription drugs, and herbal products).||
1811|088|P|   During pregnancy, this medication should be used only when||
1811|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
1811|090|P|   It is unknown if this medication passes into breast milk.||
1811|091|P|Consult your doctor before breastfeeding.||
1811|092|B|||
1811|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1811|094|I|medications work or increase your risk for serious side effects.||
1811|095|I|This document does not contain all possible drug interactions.||
1811|096|I|Keep a list of all the products you use (including||
1811|097|I|prescription/nonprescription drugs and herbal products) and share||
1811|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
1811|099|I|the dosage of any medicines without your doctor's approval.||
1811|100|B|||
1811|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1811|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1811|103|O|poison control center right away. US residents can call||
1811|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1811|105|B|||
1811|106|N|NOTES:  Do not share this medication with others.||
1811|107|B|||
1811|108|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1811|109|D|next dose at the regular time. Do not double the dose to catch||
1811|110|D|up.||
1811|111|B|||
1811|112|R|STORAGE:  Store in the original container at room temperature||
1811|113|R|away from light and moisture. Do not store in the bathroom. Keep||
1811|114|R|all medications away from children and pets.||
1811|115|R|   Do not flush medications down the toilet or pour them into a||
1811|116|R|drain unless instructed to do so. Properly discard this product||
1811|117|R|when it is expired or no longer needed. Consult your pharmacist||
1811|118|R|or local waste disposal company.||
1811|119|B|||
1811|120|A|Information last revised May 2024.||
1811|121|A|Copyright(c) 2025 First Databank, Inc.||
1811|122|B|||
1812|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1812|002|Z|does NOT have all possible information about this product. This||
1812|003|Z|information does not assure that this product is safe, effective,||
1812|004|Z|or appropriate for you. This information is not individual||
1812|005|Z|medical advice and does not substitute for the advice of your||
1812|006|Z|health care professional. Always ask your health care||
1812|007|Z|professional for complete information about this product and your||
1812|008|Z|specific health needs.||
1812|009|B|||
1812|010|T|NADROPARIN - INJECTION||
1812|011|F|(NAY-droe-PAR-in)||
1812|012|B|||
1812|013|W|WARNING:  People using this medication may bleed near the spinal||
1812|014|W|cord after certain spinal procedures. Bleeding in this area can||
1812|015|W|cause paralysis that lasts a long time or could become permanent.||
1812|016|W|Talk with your doctor about the benefits and risks before any||
1812|017|W|spinal procedure. Your doctor may direct you to stop this||
1812|018|W|medication for a certain amount of time before and after the||
1812|019|W|procedure. Carefully follow your doctor's directions.||
1812|020|W|   The risk of bleeding may be higher if you have a deformed||
1812|021|W|spine, or have had spinal procedures/surgery before (such as||
1812|022|W|epidural catheter placement, difficult epidural/spinal puncture),||
1812|023|W|or are taking other drugs that can cause bleeding/bruising||
1812|024|W|(including antiplatelet drugs such as clopidogrel, "blood||
1812|025|W|thinners" such as warfarin/rivaroxaban, nonsteroidal||
1812|026|W|anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your||
1812|027|W|doctor right away if you have symptoms such as back pain, leg||
1812|028|W|numbness/tingling/weakness, loss of control of the bowels or||
1812|029|W|bladder (incontinence).||
1812|030|B|||
1812|031|U|USES:  Nadroparin is used to prevent and treat harmful blood||
1812|032|U|clots. This helps to reduce the risk of a stroke or heart attack.||
1812|033|U|This medication helps keep your blood flowing smoothly by||
1812|034|U|lowering the activity of clotting proteins in the blood.||
1812|035|U|Nadroparin is an anticoagulant, also known as a "blood thinner."||
1812|036|U|It is a type of heparin.||
1812|037|U|   Conditions which increase your risk of developing blood clots||
1812|038|U|include certain types of surgeries (such as knee/hip replacement,||
1812|039|U|abdominal), long periods of being immobile, certain types of||
1812|040|U|heart attack, and a specific type of chest pain called unstable||
1812|041|U|angina. For some medical conditions, nadroparin may be used in||
1812|042|U|combination with other blood thinners.||
1812|043|B|||
1812|044|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1812|045|H|from your pharmacist before you start using nadroparin and each||
1812|046|H|time you get a refill. Ask your health care professional how to||
1812|047|H|prepare and use this medication. If you have any questions, ask||
1812|048|H|your doctor or pharmacist.||
1812|049|H|   Inject this medication under the skin as directed by your||
1812|050|H|doctor, usually once or twice a day. The injection is given in||
1812|051|H|the abdomen. Do not inject into a muscle. The dosage and length||
1812|052|H|of treatment are based on your medical condition, weight, and||
1812|053|H|response to treatment.||
1812|054|H|   Nadroparin comes in different strengths. Check that you are||
1812|055|H|using the correct strength and dose before injecting this||
1812|056|H|medication.||
1812|057|H|   Before using, check this product for particles or||
1812|058|H|discoloration. If either is present, do not use the liquid.||
1812|059|H|Before injecting each dose, clean the skin you are going to||
1812|060|H|inject into (the injection site) with rubbing alcohol. Change the||
1812|061|H|injection site each time to lessen injury under the skin. To||
1812|062|H|lessen bruising, do not rub the injection site after a shot.||
1812|063|H|Learn how to store and discard medical supplies safely.||
1812|064|H|   Use this medication regularly to get the most benefit from it.||
1812|065|H|To help you remember, use it at the same time(s) each day.||
1812|066|B|||
1812|067|S|SIDE EFFECTS:  See also Warning section.||
1812|068|S|   Mild irritation, pain, bruising, redness, or swelling at the||
1812|069|S|injection site may occur. If any of these effects last or get||
1812|070|S|worse, tell your doctor or pharmacist promptly.||
1812|071|S|   Remember that this medication has been prescribed because your||
1812|072|S|doctor has judged that the benefit to you is greater than the||
1812|073|S|risk of side effects. Many people using this medication do not||
1812|074|S|have serious side effects.||
1812|075|S|   This medication can cause bleeding if its effect on your blood||
1812|076|S|clotting proteins is too much. Tell your doctor right away if you||
1812|077|S|have any serious signs of bleeding, including: unusual||
1812|078|S|pain/swelling/discomfort, unusual or prolonged bleeding, unusual||
1812|079|S|or easy bruising, dark urine, black stools, severe headache,||
1812|080|S|confusion, vision changes, unusual dizziness, fainting, seizures,||
1812|081|S|weakness, numbness.||
1812|082|S|   A very serious allergic reaction to this drug is rare.||
1812|083|S|However, get medical help right away if you notice any symptoms||
1812|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1812|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1812|086|S|breathing.||
1812|087|S|   This is not a complete list of possible side effects. If you||
1812|088|S|notice other effects not listed above, contact your doctor or||
1812|089|S|pharmacist.||
1812|090|S|   In the US -||
1812|091|S|   Call your doctor for medical advice about side effects. You||
1812|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1812|093|S|www.fda.gov/medwatch.||
1812|094|S|   In Canada - Call your doctor for medical advice about side||
1812|095|S|effects. You may report side effects to Health Canada at||
1812|096|S|1-866-234-2345.||
1812|097|B|||
1812|098|P|PRECAUTIONS:  Before using nadroparin, tell your doctor or||
1812|099|P|pharmacist if you are allergic to it; or to heparin; or if you||
1812|100|P|have any other allergies. This product may contain inactive||
1812|101|P|ingredients (such as latex), which can cause allergic reactions||
1812|102|P|or other problems. Talk to your pharmacist for more details.||
1812|103|P|   Before using nadroparin, tell your doctor or pharmacist your||
1812|104|P|medical history, especially of: serious active bleeding,||
1812|105|P|artificial heart valve(s), kidney disease, liver disease,||
1812|106|P|bleeding or blood disorders (such as low platelet counts), low||
1812|107|P|platelet counts after previous heparin treatment, stroke, high||
1812|108|P|blood pressure, certain eye problems (such as diabetic||
1812|109|P|retinopathy), certain stomach/intestinal problems (such as active||
1812|110|P|or recent ulcers), recent spinal procedure or puncture, spine||
1812|111|P|problems (such as spinal deformity), recent eye/brain/spinal cord||
1812|112|P|surgery.||
1812|113|P|   Limit alcohol while using this drug because it may increase||
1812|114|P|the risk of stomach bleeding.||
1812|115|P|   Before having surgery, tell your doctor or dentist about all||
1812|116|P|the products you use (including prescription drugs,||
1812|117|P|nonprescription drugs, and herbal products).||
1812|118|P|   To lower the chance of getting cut, bruised, or injured, use||
1812|119|P|caution with sharp objects like razors and nail cutters, and||
1812|120|P|avoid activities such as contact sports.||
1812|121|P|   Older adults may be more sensitive to the side effects of this||
1812|122|P|drug, especially bleeding.||
1812|123|P|   During pregnancy, this medication should be used only when||
1812|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
1812|125|P|   It is unknown if this drug passes into breast milk. Consult||
1812|126|P|your doctor before breastfeeding.||
1812|127|B|||
1812|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1812|129|I|medications work or increase your risk for serious side effects.||
1812|130|I|This document does not contain all possible drug interactions.||
1812|131|I|Keep a list of all the products you use (including||
1812|132|I|prescription/nonprescription drugs and herbal products) and share||
1812|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
1812|134|I|the dosage of any medicines without your doctor's approval.||
1812|135|I|   A product that may interact with this drug is: mifepristone.||
1812|136|I|   This medication is sometimes used together with other drugs||
1812|137|I|that have "blood thinning" or anti-platelet effects such as||
1812|138|I|aspirin, clopidogrel, or warfarin. When these combinations are||
1812|139|I|prescribed by your doctor, you will require closer monitoring to||
1812|140|I|minimize your risk of bleeding. Keep all medical and lab||
1812|141|I|appointments.||
1812|142|I|   Check all prescription and nonprescription medicine labels||
1812|143|I|carefully since many medications contain pain relievers/fever||
1812|144|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen) which||
1812|145|I|can increase the risk of bleeding/anti-platelet effect when used||
1812|146|I|with nadroparin. However, if your doctor has told you to take||
1812|147|I|low-dose aspirin to prevent heart attack or stroke (usually||
1812|148|I|81-162 milligrams a day), you should keep taking the aspirin||
1812|149|I|unless your doctor tells you not to. Ask your doctor or||
1812|150|I|pharmacist for more details.||
1812|151|B|||
1812|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1812|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1812|154|O|poison control center right away. US residents can call||
1812|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1812|156|O|Symptoms of overdose may include: excessive bleeding and||
1812|157|O|bruising.||
1812|158|B|||
1812|159|N|NOTES:  Do not share this medication with others.||
1812|160|N|   Lab and/or medical tests (such as complete blood count,||
1812|161|N|anti-factor Xa blood levels) should be done while you are using||
1812|162|N|this medication. Keep all medical and lab appointments. Consult||
1812|163|N|your doctor for more details.||
1812|164|B|||
1812|165|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1812|166|D|If it is near the time of the next dose, skip the missed dose.||
1812|167|D|Use your next dose at the regular time. Do not double the dose to||
1812|168|D|catch up.||
1812|169|B|||
1812|170|R|STORAGE:  Store at room temperature. Keep all medications away||
1812|171|R|from children and pets.||
1812|172|R|   Do not flush medications down the toilet or pour them into a||
1812|173|R|drain unless instructed to do so. Properly discard this product||
1812|174|R|when it is expired or no longer needed. Consult your pharmacist||
1812|175|R|or local waste disposal company.||
1812|176|B|||
1812|177|M|MEDICAL ALERT:  Your condition can cause complications in a||
1812|178|M|medical emergency. For information about enrolling in MedicAlert,||
1812|179|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1812|180|B|||
1812|181|A|Information last revised December 2024.||
1812|182|A|Copyright(c) 2025 First Databank, Inc.||
1812|183|B|||
1813|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1813|002|Z|does NOT have all possible information about this product. This||
1813|003|Z|information does not assure that this product is safe, effective,||
1813|004|Z|or appropriate for you. This information is not individual||
1813|005|Z|medical advice and does not substitute for the advice of your||
1813|006|Z|health care professional. Always ask your health care||
1813|007|Z|professional for complete information about this product and your||
1813|008|Z|specific health needs.||
1813|009|B|||
1813|010|T|MIFEPRISTONE/MISOPROSTOL - ORAL, BUCCAL||
1813|011|F|(MIF-e-PRIS-tone/MYE-soe-PROS-tol)||
1813|012|B|||
1813|013|W|WARNING:  Rarely, serious medical problems can occur when this||
1813|014|W|medication is used to end a pregnancy, including serious||
1813|015|W|infections and bleeding. You must see a health care professional||
1813|016|W|within 7 to 14 days after taking mifepristone. The health care||
1813|017|W|professional will check if your pregnancy has completely ended.||
1813|018|W|If your pregnancy has not ended, or if there are serious medical||
1813|019|W|problems, you may need surgery. If the medication fails and the||
1813|020|W|pregnancy continues until birth, there is a risk of birth||
1813|021|W|defects.||
1813|022|W|   You may have a very serious infection even if you do not have||
1813|023|W|a fever. Get medical help right away if you have abdominal pain||
1813|024|W|or feel sick (such as having nausea, vomiting, diarrhea,||
1813|025|W|weakness) more than 24 hours after taking the second drug||
1813|026|W|(misoprostol), even if you do not have a fever. Also get medical||
1813|027|W|help right away if you have heavy bleeding that doesn't stop,||
1813|028|W|which may be a sign your pregnancy has not ended or other serious||
1813|029|W|medical problem.||
1813|030|W|   If you do not want to get pregnant after ending your||
1813|031|W|pregnancy, you must start using birth control right away. Tell||
1813|032|W|your health care professional if you want to get pregnant again||
1813|033|W|right taking this medication. To decrease the chance of birth||
1813|034|W|defects, avoid getting pregnant again before your next menstrual||
1813|035|W|period.||
1813|036|B|||
1813|037|U|USES:  This product is used to end an early pregnancy. It is used||
1813|038|U|up to 63 days after the first day of your last menstrual period.||
1813|039|U|This product contains 2 medications: mifepristone and||
1813|040|U|misoprostol. Mifepristone works by blocking a natural hormone||
1813|041|U|(progesterone) that is needed for the pregnancy to continue.||
1813|042|U|Misoprostol works by making the womb (uterus) contract and the||
1813|043|U|opening of the cervix relax, which causes the contents in the||
1813|044|U|womb to pass out of the body.||
1813|045|U|   Mifepristone and misoprostol must not be used if you have a||
1813|046|U|rare abnormal pregnancy that is outside the womb (ectopic||
1813|047|U|pregnancy). In this case, the ectopic pregnancy may suddenly||
1813|048|U|break, resulting in very serious bleeding.||
1813|049|B|||
1813|050|H|HOW TO USE:  See also Warning section.||
1813|051|H|   Before treatment, your health care professional must make sure||
1813|052|H|your pregnancy is not outside the womb (ectopic), and check how||
1813|053|H|long you have been pregnant.||
1813|054|H|   Read the Patient Information Leaflet provided by your health||
1813|055|H|care professional before you start using this product. If you||
1813|056|H|have any questions, ask your health care professional. Read and||
1813|057|H|sign the consent form and Patient Information Card provided by||
1813|058|H|your health care professional and keep the Patient Information||
1813|059|H|Card with you while using this product and until your health care||
1813|060|H|professional tells you that your treatment was successful.||
1813|061|H|   Take mifepristone by mouth as directed by your health care||
1813|062|H|professional, usually as a single dose. Swallow the mifepristone||
1813|063|H|with a glass of water. After taking mifepristone, wait 24 to 48||
1813|064|H|hours, then take the misoprostol (as a single dose). To take the||
1813|065|H|misoprostol, place the tablets between your cheeks and gums and||
1813|066|H|allow to dissolve for 30 minutes. If there are still some tablet||
1813|067|H|pieces left in your mouth after 30 minutes, swallow them with a||
1813|068|H|glass of water. Plan to rest for 3 hours after taking the||
1813|069|H|misoprostol tablets. The medications may not work as well if you||
1813|070|H|take misoprostol sooner than 24 hours after taking mifepristone||
1813|071|H|or later than 48 hours after taking mifepristone. Carefully||
1813|072|H|follow your health care professional's directions. Heavy vaginal||
1813|073|H|bleeding does not mean that your treatment was successful. Be||
1813|074|H|sure you know who to call and what to do in case of emergency.||
1813|075|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1813|076|H|using this medication unless your health care professional says||
1813|077|H|you may do so safely. Grapefruit can increase the chance of side||
1813|078|H|effects with mifepristone. Ask your doctor or pharmacist for more||
1813|079|H|details.||
1813|080|B|||
1813|081|S|SIDE EFFECTS:  See also Warning section.||
1813|082|S|   Breast tenderness, headache, nausea, vomiting, diarrhea,||
1813|083|S|tiredness, or dizziness may occur. If nausea, vomiting, diarrhea,||
1813|084|S|or weakness last longer than 24 hours after taking the second||
1813|085|S|drug (misoprostol), get medical help right away.||
1813|086|S|   Bleeding and cramping are expected during this treatment.||
1813|087|S|Vaginal bleeding usually starts a few hours after taking the||
1813|088|S|misoprostol. These symptoms usually mean the drugs are working.||
1813|089|S|However, sometimes you can have cramps and bleeding and still be||
1813|090|S|pregnant. You must keep all of your follow-up visits so your||
1813|091|S|health care professional can check if your treatment was||
1813|092|S|successful.||
1813|093|S|   Nausea and cramping may get worse in the first 24 hours after||
1813|094|S|you take the second drug (misoprostol). Your health care||
1813|095|S|professional may direct you to take other medication(s) to help||
1813|096|S|with these symptoms. Bleeding and spotting usually last about 11||
1813|097|S|days and may be much heavier than a normal period. Rarely, this||
1813|098|S|bleeding may need to be stopped by surgery. Get medical help||
1813|099|S|right away if you bleed enough to soak through 2 thick, full-size||
1813|100|S|sanitary pads each hour for 2 hours in a row, or if you are||
1813|101|S|worried about heavy bleeding.||
1813|102|S|   Remember that this product has been prescribed because your||
1813|103|S|health care professional has judged that the benefit to you is||
1813|104|S|greater than the risk of side effects. Many people using this||
1813|105|S|product do not have serious side effects.||
1813|106|S|   Get medical help right away if you have any very serious side||
1813|107|S|effects, including: fever, fainting, fast heartbeat, severe||
1813|108|S|stomach/abdominal pain or tenderness.||
1813|109|S|   A very serious allergic reaction to this drug is rare.||
1813|110|S|However, get medical help right away if you notice any symptoms||
1813|111|S|of a serious allergic reaction, including: rash, itching/swelling||
1813|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1813|113|S|breathing.||
1813|114|S|   This is not a complete list of possible side effects. If you||
1813|115|S|notice other effects not listed above, contact your health care||
1813|116|S|professional.||
1813|117|S|   In the US -||
1813|118|S|   Call your health care professional for medical advice about||
1813|119|S|side effects. You may report side effects to FDA at||
1813|120|S|1-800-FDA-1088 or at www.fda.gov/medwatch.||
1813|121|S|   In Canada - Call your health care professional for medical||
1813|122|S|advice about side effects. You may report side effects to Health||
1813|123|S|Canada at 1-866-234-2345.||
1813|124|B|||
1813|125|P|PRECAUTIONS:  Before taking this product, tell your health care||
1813|126|P|professional if you are allergic to mifepristone or misoprostol;||
1813|127|P|or if you have any other allergies. This product may contain||
1813|128|P|inactive ingredients, which can cause allergic reactions or other||
1813|129|P|problems. Talk to your health care professional for more details.||
1813|130|P|   Before using this medication, tell your health care||
1813|131|P|professional your medical history, especially of: a certain||
1813|132|P|adrenal gland problem (chronic adrenal failure), bleeding/blood||
1813|133|P|problems (such as anemia), IUD (intrauterine birth control||
1813|134|P|device).||
1813|135|P|   This product may make you dizzy. Alcohol or marijuana||
1813|136|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
1813|137|P|or do anything that needs alertness until you can do it safely.||
1813|138|P|Limit alcoholic beverages. Talk to your health care professional||
1813|139|P|if you are using marijuana (cannabis).||
1813|140|P|   If you are using an IUD (intrauterine birth control device),||
1813|141|P|it should be removed before using this product.||
1813|142|P|   Before having surgery, tell your doctor or dentist about all||
1813|143|P|the products you use (including prescription drugs,||
1813|144|P|nonprescription drugs, and herbal products).||
1813|145|P|   Another pregnancy can occur after this treatment and before||
1813|146|P|your normal period begins again. If you do not want to get||
1813|147|P|pregnant after ending your pregnancy, you must start using birth||
1813|148|P|control right away. To decrease the chance of birth defects,||
1813|149|P|avoid getting pregnant again before your next menstrual period.||
1813|150|P|   Mifepristone and misoprostol pass into breast milk. Consult||
1813|151|P|your health care professional before breastfeeding.||
1813|152|B|||
1813|153|I|DRUG INTERACTIONS:  See also How to Use section.||
1813|154|I|   Drug interactions may change how your medications work or||
1813|155|I|increase your risk for serious side effects. This document does||
1813|156|I|not contain all possible drug interactions. Keep a list of all||
1813|157|I|the products you use (including prescription/nonprescription||
1813|158|I|drugs and herbal products) and share it with your health care||
1813|159|I|professional. Do not start, stop, or change the dosage of any||
1813|160|I|medicines without your doctor's approval.||
1813|161|I|   Some products that may interact with this drug are: other||
1813|162|I|drugs that can cause bleeding/bruising (including antiplatelet||
1813|163|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
1813|164|I|"blood thinners" such as warfarin/dabigatran).||
1813|165|I|   Aspirin can increase the risk of bleeding when used with this||
1813|166|I|medication. However, if your doctor has told you to take low-dose||
1813|167|I|aspirin to prevent heart attack or stroke (usually 81-162||
1813|168|I|milligrams a day), you should keep taking the aspirin unless your||
1813|169|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1813|170|I|details.||
1813|171|I|   Other medications can affect the removal of mifepristone from||
1813|172|I|your body, which may affect how mifepristone works. Examples||
1813|173|I|include azole antifungals (such as itraconazole, ketoconazole),||
1813|174|I|macrolide antibiotics (such as erythromycin), dexamethasone,||
1813|175|I|rifamycins (such as rifampin, rifabutin), St. John's wort, drugs||
1813|176|I|used to treat seizures (such as carbamazepine, phenytoin), among||
1813|177|I|others.||
1813|178|I|   Mifepristone can slow down the removal of other medications||
1813|179|I|from your body, which may affect how they work. Examples of||
1813|180|I|affected drugs include cyclosporine, ergot alkaloids (such as||
1813|181|I|dihydroergotamine, ergotamine), fentanyl, pimozide, quinidine,||
1813|182|I|some statin drugs (such as fluvastatin, lovastatin, simvastatin),||
1813|183|I|sirolimus, tacrolimus, warfarin, among others.||
1813|184|B|||
1813|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1813|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1813|187|O|poison control center right away. US residents can call||
1813|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1813|189|B|||
1813|190|N|NOTES:  Lab and/or medical tests (such as ultrasound) must be||
1813|191|N|done before you start taking this medication and after taking it.||
1813|192|N|Keep all medical and lab appointments.||
1813|193|B|||
1813|194|D|MISSED DOSE:  You must follow the dosing and appointment schedule||
1813|195|D|as directed by your health care professional. Contact your health||
1813|196|D|care professional right away if you forget to take the dose of||
1813|197|D|misoprostol tablets and it is more than 48 hours after you have||
1813|198|D|taken mifepristone. If you miss an appointment, contact your||
1813|199|D|health care professional right away.||
1813|200|B|||
1813|201|R|STORAGE:  Store at room temperature away from light and moisture.||
1813|202|R|Keep all medications away from children and pets.||
1813|203|R|   Do not flush medications down the toilet or pour them into a||
1813|204|R|drain unless instructed to do so. Properly discard this product||
1813|205|R|when it is expired or no longer needed. Consult your pharmacist||
1813|206|R|or local waste disposal company.||
1813|207|B|||
1813|208|A|Information last revised May 2024.||
1813|209|A|Copyright(c) 2025 First Databank, Inc.||
1813|210|B|||
1815|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1815|002|Z|does NOT have all possible information about this product. This||
1815|003|Z|information does not assure that this product is safe, effective,||
1815|004|Z|or appropriate for you. This information is not individual||
1815|005|Z|medical advice and does not substitute for the advice of your||
1815|006|Z|health care professional. Always ask your health care||
1815|007|Z|professional for complete information about this product and your||
1815|008|Z|specific health needs.||
1815|009|B|||
1815|010|T|OXYMETAZOLINE CREAM - TOPICAL||
1815|011|F|(OX-i-me-TAZ-oh-leen)||
1815|012|B|||
1815|013|C|COMMON BRAND NAME(S): Rhofade||
1815|014|B|||
1815|015|U|USES:  This medication is used to treat a certain skin disorder||
1815|016|U|known as rosacea. It works by narrowing the blood vessels in the||
1815|017|U|face. Oxymetazoline belongs to a class of drugs known as a||
1815|018|U|sympathomimetic (alpha receptor agonist). It may help to decrease||
1815|019|U|facial redness caused by rosacea.||
1815|020|B|||
1815|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
1815|022|H|instructions for use if available from your pharmacist before you||
1815|023|H|start using oxymetazoline and each time you get a refill. If you||
1815|024|H|have any questions, ask your doctor or pharmacist.||
1815|025|H|   Use this medication on the skin only. Do not apply on||
1815|026|H|irritated or broken skin. Apply a thin layer of medication to||
1815|027|H|cover your entire face (forehead, nose, cheeks, and chin) as||
1815|028|H|directed by your doctor, usually once daily. Wash your hands||
1815|029|H|right after applying this medication. Do not use in your eyes,||
1815|030|H|mouth, or vagina. Avoid contact with your lips and eyes. If you||
1815|031|H|accidentally get this medication in your eyes, rinse with large||
1815|032|H|amounts of cool water.||
1815|033|H|   If you are using the pump, read the instructions for use to||
1815|034|H|learn how to correctly prime the pump before using it for the||
1815|035|H|first time. The tubes do not need priming.||
1815|036|H|   Use this medication regularly to get the most benefit from it.||
1815|037|H|To help you remember, use it at the same time each day. Do not||
1815|038|H|use more of this medication or use it more often or for longer||
1815|039|H|than prescribed. Your skin will not improve any faster, and your||
1815|040|H|risk of side effects will increase.||
1815|041|H|   Tell your doctor if your condition lasts or gets worse.||
1815|042|B|||
1815|043|S|SIDE EFFECTS:  Skin reactions (dermatitis), redness, pain, or||
1815|044|S|worsening of rosacea pimples may occur. If any of these effects||
1815|045|S|last or get worse, tell your doctor or pharmacist promptly.||
1815|046|S|   Remember that this medication has been prescribed because your||
1815|047|S|doctor has judged that the benefit to you is greater than the||
1815|048|S|risk of side effects. Many people using this medication do not||
1815|049|S|have serious side effects.||
1815|050|S|   A very serious allergic reaction to this drug is rare.||
1815|051|S|However, get medical help right away if you notice any symptoms||
1815|052|S|of a serious allergic reaction, including: rash, itching/swelling||
1815|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1815|054|S|breathing.||
1815|055|S|   This is not a complete list of possible side effects. If you||
1815|056|S|notice other effects not listed above, contact your doctor or||
1815|057|S|pharmacist.||
1815|058|S|   In the US -||
1815|059|S|   Call your doctor for medical advice about side effects. You||
1815|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1815|061|S|www.fda.gov/medwatch.||
1815|062|S|   In Canada - Call your doctor for medical advice about side||
1815|063|S|effects. You may report side effects to Health Canada at||
1815|064|S|1-866-234-2345.||
1815|065|B|||
1815|066|P|PRECAUTIONS:  Before using oxymetazoline, tell your doctor or||
1815|067|P|pharmacist if you are allergic to it; or if you have any other||
1815|068|P|allergies. This product may contain inactive ingredients, which||
1815|069|P|can cause allergic reactions or other problems. Talk to your||
1815|070|P|pharmacist for more details.||
1815|071|P|   Before using this medication, tell your doctor or pharmacist||
1815|072|P|your medical history, especially of: glaucoma.||
1815|073|P|   Before having surgery, tell your doctor or dentist about all||
1815|074|P|the products you use (including prescription drugs,||
1815|075|P|nonprescription drugs, and herbal products).||
1815|076|P|   During pregnancy, this medication should be used only when||
1815|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
1815|078|P|   It is unknown if this medication passes into breast milk.||
1815|079|P|Consult your doctor before breastfeeding.||
1815|080|B|||
1815|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1815|082|I|medications work or increase your risk for serious side effects.||
1815|083|I|This document does not contain all possible drug interactions.||
1815|084|I|Keep a list of all the products you use (including||
1815|085|I|prescription/nonprescription drugs and herbal products) and share||
1815|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
1815|087|I|the dosage of any medicines without your doctor's approval.||
1815|088|B|||
1815|089|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1815|090|O|has overdosed and has serious symptoms such as passing out or||
1815|091|O|trouble breathing, call 911. Otherwise, call a poison control||
1815|092|O|center right away. US residents can call 1-800-222-1222. Canada||
1815|093|O|residents can call 1-844-764-7669.||
1815|094|B|||
1815|095|N|NOTES:  Do not share this medication with others.||
1815|096|N|   This medication has been prescribed for your current condition||
1815|097|N|only. Do not use it later for another condition unless your||
1815|098|N|doctor directs you to do so. A different medication may be||
1815|099|N|necessary in that case.||
1815|100|N|   Sun can worsen rosacea. Wear a wide-brimmed hat and use a||
1815|101|N|sunscreen that is SPF 15 or greater.||
1815|102|N|   Avoid triggers that may worsen rosacea such as wind, hot||
1815|103|N|beverages, spicy foods, alcohol, and extreme cold. Discuss with||
1815|104|N|your doctor.||
1815|105|B|||
1815|106|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1815|107|D|If it is near the time of the next dose, skip the missed dose.||
1815|108|D|Use your next dose at the regular time. Do not double the dose to||
1815|109|D|catch up.||
1815|110|B|||
1815|111|R|STORAGE:  Store at room temperature. Keep all medications away||
1815|112|R|from children and pets.||
1815|113|R|   Do not flush medications down the toilet or pour them into a||
1815|114|R|drain unless instructed to do so. Properly discard this product||
1815|115|R|when it is expired or no longer needed. Consult your pharmacist||
1815|116|R|or local waste disposal company.||
1815|117|B|||
1815|118|A|Information last revised May 2024.||
1815|119|A|Copyright(c) 2025 First Databank, Inc.||
1815|120|B|||
1816|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1816|002|Z|does NOT have all possible information about this product. This||
1816|003|Z|information does not assure that this product is safe, effective,||
1816|004|Z|or appropriate for you. This information is not individual||
1816|005|Z|medical advice and does not substitute for the advice of your||
1816|006|Z|health care professional. Always ask your health care||
1816|007|Z|professional for complete information about this product and your||
1816|008|Z|specific health needs.||
1816|009|B|||
1816|010|T|RIBOCICLIB - ORAL||
1816|011|F|(RYE-boe-SYE-klib)||
1816|012|B|||
1816|013|C|COMMON BRAND NAME(S): Kisqali||
1816|014|B|||
1816|015|U|USES:  Ribociclib is used to treat breast cancer. It works by||
1816|016|U|slowing or stopping the growth of cancer cells.||
1816|017|B|||
1816|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1816|019|H|from your pharmacist before you start taking ribociclib and each||
1816|020|H|time you get a refill. If you have any questions, ask your doctor||
1816|021|H|or pharmacist.||
1816|022|H|   Take this medication by mouth with or without food as directed||
1816|023|H|by your doctor, usually once daily in the morning for 21 days,||
1816|024|H|then stopping the medication for 7 days. This is one cycle of||
1816|025|H|treatment. Keep taking the medication this way as directed by||
1816|026|H|your doctor.||
1816|027|H|   Swallow the tablet(s) whole. Do not crush, chew, or break the||
1816|028|H|tablet(s). Also, do not take a tablet that is damaged or broken.||
1816|029|H|   If you vomit after taking a dose, do not take another dose at||
1816|030|H|that time. Take your next dose at the regular time.||
1816|031|H|   The dosage is based on your medical condition, response to||
1816|032|H|treatment, lab tests, and other medications you may be taking. Be||
1816|033|H|sure to tell your doctor and pharmacist about all the products||
1816|034|H|you use (including prescription drugs, nonprescription drugs, and||
1816|035|H|herbal products).||
1816|036|H|   Use this medication regularly to get the most benefit from it.||
1816|037|H|To help you remember, take it at the same time each day.||
1816|038|H|   Do not increase your dose or use this drug more often or for||
1816|039|H|longer than prescribed. Your condition will not improve any||
1816|040|H|faster, and your risk of serious side effects will increase.||
1816|041|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1816|042|H|using this medication unless your doctor or pharmacist says you||
1816|043|H|may do so safely. Grapefruit can increase the chance of side||
1816|044|H|effects with this medicine. Ask your doctor or pharmacist for||
1816|045|H|more details.||
1816|046|H|   Since this drug can be absorbed through the skin and lungs and||
1816|047|H|may harm an unborn baby, women who are pregnant or who may become||
1816|048|H|pregnant should not handle this medication or breathe the dust||
1816|049|H|from the tablets.||
1816|050|B|||
1816|051|S|SIDE EFFECTS:  Tiredness, diarrhea, headache, back pain, nausea,||
1816|052|S|vomiting, or loss of appetite may occur. Nausea and vomiting can||
1816|053|S|be severe. In some cases, your doctor may prescribe medication to||
1816|054|S|prevent or relieve nausea and vomiting. Eating several small||
1816|055|S|meals, not eating before treatment, or limiting activity may help||
1816|056|S|lessen some of these effects. If any of these effects last or get||
1816|057|S|worse, tell your doctor or pharmacist promptly.||
1816|058|S|   Temporary hair loss may occur. Normal hair growth should||
1816|059|S|return after treatment has ended.||
1816|060|S|   Pain or sores in the mouth and throat may occur. Brush your||
1816|061|S|teeth carefully/gently, avoid using mouthwash that contains||
1816|062|S|alcohol, and rinse your mouth often with cool water mixed with||
1816|063|S|baking soda or salt. It may also be best to eat soft, moist||
1816|064|S|foods.||
1816|065|S|   People using this medication may have serious side effects.||
1816|066|S|However, you have been prescribed this drug because your doctor||
1816|067|S|has judged that the benefit to you is greater than the risk of||
1816|068|S|side effects. Careful monitoring by your doctor may decrease your||
1816|069|S|risk.||
1816|070|S|   Tell your doctor right away if you have any serious side||
1816|071|S|effects, including: shortness of breath, signs of liver disease||
1816|072|S|(such as nausea/vomiting that doesn't stop, stomach/abdominal||
1816|073|S|pain, yellowing eyes/skin, dark urine).||
1816|074|S|   Get medical help right away if you have any very serious side||
1816|075|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1816|076|S|fainting, chest pain.||
1816|077|S|   This medication may lower your ability to fight infections.||
1816|078|S|This may make you more likely to get a serious (rarely fatal)||
1816|079|S|infection or make any infection you have worse. Get medical help||
1816|080|S|right away if you have any signs of infection (such as sore||
1816|081|S|throat that doesn't go away, fever, swollen lymph nodes, chills).||
1816|082|S|   A very serious allergic reaction to this drug is rare.||
1816|083|S|However, get medical help right away if you notice any symptoms||
1816|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1816|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1816|086|S|breathing.||
1816|087|S|   This is not a complete list of possible side effects. If you||
1816|088|S|notice other effects not listed above, contact your doctor or||
1816|089|S|pharmacist.||
1816|090|S|   In the US -||
1816|091|S|   Call your doctor for medical advice about side effects. You||
1816|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1816|093|S|www.fda.gov/medwatch.||
1816|094|S|   In Canada - Call your doctor for medical advice about side||
1816|095|S|effects. You may report side effects to Health Canada at||
1816|096|S|1-866-234-2345.||
1816|097|B|||
1816|098|P|PRECAUTIONS:  Before taking ribociclib, tell your doctor or||
1816|099|P|pharmacist if you are allergic to it; or if you have any other||
1816|100|P|allergies. This product may contain inactive ingredients, which||
1816|101|P|can cause allergic reactions or other problems. Talk to your||
1816|102|P|pharmacist for more details.||
1816|103|P|   Before using this medication, tell your doctor or pharmacist||
1816|104|P|your medical history, especially of: liver disease, kidney||
1816|105|P|disease.||
1816|106|P|   Ribociclib may cause a condition that affects the heart rhythm||
1816|107|P|(QT prolongation). QT prolongation can rarely cause serious||
1816|108|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1816|109|P|as severe dizziness, fainting) that need medical attention right||
1816|110|P|away.||
1816|111|P|   The risk of QT prolongation may be increased if you have||
1816|112|P|certain medical conditions or are taking other drugs that may||
1816|113|P|cause QT prolongation. Before using ribociclib, tell your doctor||
1816|114|P|or pharmacist of all the drugs you take and if you have any of||
1816|115|P|the following conditions: certain heart problems (heart failure,||
1816|116|P|slow heartbeat, QT prolongation in the EKG), family history of||
1816|117|P|certain heart problems (QT prolongation in the EKG, sudden||
1816|118|P|cardiac death).||
1816|119|P|   Low levels of potassium or magnesium in the blood may also||
1816|120|P|increase your risk of QT prolongation. This risk may increase if||
1816|121|P|you use certain drugs (such as diuretics "water pills") or if you||
1816|122|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1816|123|P|Talk to your doctor about using ribociclib safely.||
1816|124|P|   Ribociclib can make you more likely to get infections or may||
1816|125|P|make current infections worse. Stay away from anyone who has an||
1816|126|P|infection that may easily spread (such as chickenpox, COVID-19,||
1816|127|P|measles, flu). Talk to your doctor if you have been exposed to an||
1816|128|P|infection or for more details.||
1816|129|P|   Tell your health care professional that you are using||
1816|130|P|ribociclib before having any immunizations/vaccinations. Avoid||
1816|131|P|contact with people who have recently received live vaccines||
1816|132|P|(such as flu vaccine inhaled through the nose).||
1816|133|P|   Before having surgery, tell your doctor or dentist about all||
1816|134|P|the products you use (including prescription drugs,||
1816|135|P|nonprescription drugs, and herbal products).||
1816|136|P|   Older adults may be more sensitive to the side effects of this||
1816|137|P|drug, especially QT prolongation (see above).||
1816|138|P|   Tell your doctor if you are pregnant or plan to become||
1816|139|P|pregnant. You should not become pregnant while using ribociclib.||
1816|140|P|Ribociclib may harm an unborn baby. Your doctor should order a||
1816|141|P|pregnancy test before your start this medication. Ask about||
1816|142|P|reliable forms of birth control while using this medication and||
1816|143|P|for 3 weeks after the last dose. If you become pregnant, talk to||
1816|144|P|your doctor right away about the risks and benefits of this||
1816|145|P|medication.||
1816|146|P|   Since this drug can be absorbed through the skin and lungs and||
1816|147|P|may harm an unborn baby, women who are pregnant or who may become||
1816|148|P|pregnant should not handle this medication or breathe the dust||
1816|149|P|from the tablets.||
1816|150|P|   It is unknown if this drug passes into breast milk. Because of||
1816|151|P|the possible risk to the infant, breastfeeding is not recommended||
1816|152|P|while using this drug and for at least 3 weeks after the last||
1816|153|P|dose. Consult your doctor before breastfeeding.||
1816|154|B|||
1816|155|I|DRUG INTERACTIONS:  See also How to Use section.||
1816|156|I|   Drug interactions may change how your medications work or||
1816|157|I|increase your risk for serious side effects. This document does||
1816|158|I|not contain all possible drug interactions. Keep a list of all||
1816|159|I|the products you use (including prescription/nonprescription||
1816|160|I|drugs and herbal products) and share it with your doctor and||
1816|161|I|pharmacist. Do not start, stop, or change the dosage of any||
1816|162|I|medicines without your doctor's approval.||
1816|163|I|   A product that may interact with this drug is: tamoxifen.||
1816|164|I|   Other medications can affect the removal of ribociclib from||
1816|165|I|your body, which may affect how ribociclib works. Examples||
1816|166|I|include lonafarnib, rifamycins (such as rifabutin), St. John's||
1816|167|I|wort, drugs used to treat seizures (such as carbamazepine,||
1816|168|I|phenytoin), among others.||
1816|169|I|   This medication can slow down the removal of other medications||
1816|170|I|from your body, which may affect how they work. Examples of||
1816|171|I|affected drugs include alprazolam, eplerenone, ergot alkaloids||
1816|172|I|(such as ergotamine), estazolam, flibanserin, irinotecan,||
1816|173|I|ivabradine, mavacamten, naloxegol, ticagrelor, tolvaptan,||
1816|174|I|triazolam, among others.||
1816|175|I|   Many drugs besides ribociclib may affect the heart rhythm (QT||
1816|176|I|prolongation), such as amiodarone, chloroquine, clarithromycin,||
1816|177|I|domperidone, dronedarone, haloperidol, methadone, moxifloxacin,||
1816|178|I|pacritinib, pimozide, ranolazine, among others.||
1816|179|B|||
1816|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1816|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1816|182|O|poison control center right away. US residents can call||
1816|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1816|184|B|||
1816|185|N|NOTES:  Do not share this medication with others.||
1816|186|N|   Lab and/or medical tests (such as EKG, liver function,||
1816|187|N|complete blood count, potassium and magnesium blood levels)||
1816|188|N|should be done before you start taking this medication and while||
1816|189|N|you are taking it. Keep all medical and lab appointments. Consult||
1816|190|N|your doctor for more details.||
1816|191|B|||
1816|192|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1816|193|D|next dose at the regular time. Do not double the dose to catch||
1816|194|D|up.||
1816|195|B|||
1816|196|R|STORAGE:  Different brands of this medication have different||
1816|197|R|storage needs. Check the product package for instructions on how||
1816|198|R|to store your brand, or ask your pharmacist. Keep all medications||
1816|199|R|away from children and pets.||
1816|200|R|   Do not flush medications down the toilet or pour them into a||
1816|201|R|drain unless instructed to do so. Properly discard this product||
1816|202|R|when it is expired or no longer needed. Consult your pharmacist||
1816|203|R|or local waste disposal company.||
1816|204|B|||
1816|205|M|MEDICAL ALERT:  Your condition can cause complications in a||
1816|206|M|medical emergency. For information about enrolling in MedicAlert,||
1816|207|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1816|208|B|||
1816|209|A|Information last revised April 2025.||
1816|210|A|Copyright(c) 2025 First Databank, Inc.||
1816|211|B|||
1817|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1817|002|Z|does NOT have all possible information about this product. This||
1817|003|Z|information does not assure that this product is safe, effective,||
1817|004|Z|or appropriate for you. This information is not individual||
1817|005|Z|medical advice and does not substitute for the advice of your||
1817|006|Z|health care professional. Always ask your health care||
1817|007|Z|professional for complete information about this product and your||
1817|008|Z|specific health needs.||
1817|009|B|||
1817|010|T|BRODALUMAB - INJECTION||
1817|011|F|(broe-DAL-ue-mab)||
1817|012|B|||
1817|013|C|COMMON BRAND NAME(S): Siliq||
1817|014|B|||
1817|015|W|WARNING:  Rarely, brodalumab may cause serious mental/mood||
1817|016|W|changes, including depression and suicidal thoughts/attempts. Get||
1817|017|W|medical help right away if you have symptoms such as depression,||
1817|018|W|anxiety, or thoughts of suicide.||
1817|019|W|   To receive brodalumab in the United States, you must||
1817|020|W|understand, agree to, and carefully follow the requirements of||
1817|021|W|the REMS Program for this medication. If you live in Canada or||
1817|022|W|any other country, consult your doctor and pharmacist for your||
1817|023|W|country's regulations.||
1817|024|B|||
1817|025|U|USES:  This medication is used to treat plaque psoriasis.||
1817|026|U|Brodalumab belongs to a class of drugs known as monoclonal||
1817|027|U|antibodies. It works by blocking a certain natural protein in||
1817|028|U|your body (interleukin-17A) that may cause inflammation and||
1817|029|U|swelling. Brodalumab treatment may lead to reduced plaque||
1817|030|U|thickness, redness, and scaling.||
1817|031|B|||
1817|032|V|OTHER USES:  This section contains uses of this drug that are not||
1817|033|V|listed in the approved professional labeling for the drug but||
1817|034|V|that may be prescribed by your health care professional. Use this||
1817|035|V|drug for a condition that is listed in this section only if it||
1817|036|V|has been so prescribed by your health care professional.||
1817|037|V|   This medication may also be used for arthritis.||
1817|038|B|||
1817|039|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1817|040|H|provided by your pharmacist before you start using brodalumab and||
1817|041|H|each time you get a refill. Ask your health care professional how||
1817|042|H|to prepare and use this medication. If you have any questions,||
1817|043|H|ask your doctor or pharmacist.||
1817|044|H|   Before treatment with this medication, your doctor will test||
1817|045|H|you for tuberculosis (TB). Your doctor should also monitor you||
1817|046|H|for symptoms of TB during and after treatment with this drug. If||
1817|047|H|needed, treatment for TB or other infections should be given||
1817|048|H|before receiving this medication.||
1817|049|H|   Inject this medication under the skin as directed by your||
1817|050|H|doctor. The injection is given in the upper arms, thighs, or||
1817|051|H|abdomen (except for a 2-inch area around your belly button). The||
1817|052|H|dosage is based on your medical condition and response to||
1817|053|H|treatment.||
1817|054|H|   Take the medication out of the refrigerator 30 minutes before||
1817|055|H|you inject it to allow it to reach room temperature. Do not warm||
1817|056|H|up this medication any other way (for example, do not heat it in||
1817|057|H|the microwave, place it in hot water, or leave it in direct||
1817|058|H|sunlight). Do not shake the medication. Before using, check this||
1817|059|H|product for cloudiness, particles, or discoloration. If you see||
1817|060|H|any of these things, do not use the liquid. Before injecting each||
1817|061|H|dose, clean the skin you are going to inject into (the injection||
1817|062|H|site) with rubbing alcohol. Change the injection site each time||
1817|063|H|to lessen injury under the skin. Do not inject into skin that is||
1817|064|H|irritated, sore, bruised, red, hard, scarred, or affected by||
1817|065|H|psoriasis. To lessen bruising, do not rub the injection site||
1817|066|H|after a shot. Learn how to store and discard medical supplies||
1817|067|H|safely.||
1817|068|H|   Use this medication regularly to get the most benefit from it.||
1817|069|H|To help you remember, mark your calendar with a reminder.||
1817|070|H|   Tell your doctor if your condition does not get better or if||
1817|071|H|it gets worse.||
1817|072|B|||
1817|073|S|SIDE EFFECTS:  See also Warning section.||
1817|074|S|   Redness, irritation, or pain at the injection site may occur.||
1817|075|S|Cold symptoms (such as runny/stuffy nose, cough), tiredness,||
1817|076|S|diarrhea, mouth/throat pain, muscle pain, fungal infections of||
1817|077|S|the skin (such as athlete's foot, jock itch) may also occur. If||
1817|078|S|any of these effects last or get worse, tell your doctor or||
1817|079|S|pharmacist promptly.||
1817|080|S|   Remember that this medication has been prescribed because your||
1817|081|S|doctor has judged that the benefit to you is greater than the||
1817|082|S|risk of side effects. Many people using this medication do not||
1817|083|S|have serious side effects.||
1817|084|S|   This medication may lower your ability to fight infections.||
1817|085|S|This may make you more likely to get a serious (rarely fatal)||
1817|086|S|infection or make any infection you have worse. Tell your doctor||
1817|087|S|right away if you have any signs of infection (such as sore||
1817|088|S|throat that doesn't go away, fever, chills).||
1817|089|S|   Tell your doctor right away if you have any serious side||
1817|090|S|effects, including: stomach/abdominal pain, diarrhea with||
1817|091|S|blood/mucus.||
1817|092|S|   A very serious allergic reaction to this drug is rare.||
1817|093|S|However, get medical help right away if you notice any symptoms||
1817|094|S|of a serious allergic reaction, including: rash, itching/swelling||
1817|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1817|096|S|breathing.||
1817|097|S|   This is not a complete list of possible side effects. If you||
1817|098|S|notice other effects not listed above, contact your doctor or||
1817|099|S|pharmacist.||
1817|100|S|   In the US -||
1817|101|S|   Call your doctor for medical advice about side effects. You||
1817|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1817|103|S|www.fda.gov/medwatch.||
1817|104|S|   In Canada - Call your doctor for medical advice about side||
1817|105|S|effects. You may report side effects to Health Canada at||
1817|106|S|1-866-234-2345.||
1817|107|B|||
1817|108|P|PRECAUTIONS:  Before using brodalumab, tell your doctor or||
1817|109|P|pharmacist if you are allergic to it; or if you have any other||
1817|110|P|allergies. This product may contain inactive ingredients, which||
1817|111|P|can cause allergic reactions or other problems. Talk to your||
1817|112|P|pharmacist for more details.||
1817|113|P|   Before using this medication, tell your doctor or pharmacist||
1817|114|P|your medical history, especially of: current/recent/returning||
1817|115|P|infection (such as tuberculosis), bowel disease (such as Crohn's||
1817|116|P|disease), mental/mood disorders (such as depression, suicidal||
1817|117|P|thoughts).||
1817|118|P|   Brodalumab can make you more likely to get infections or may||
1817|119|P|make current infections worse. Stay away from anyone who has an||
1817|120|P|infection that may easily spread (such as chickenpox, COVID-19,||
1817|121|P|measles, flu). Talk to your doctor if you have been exposed to an||
1817|122|P|infection or for more details.||
1817|123|P|   Tell your health care professional that you are using||
1817|124|P|brodalumab before having any immunizations/vaccinations. Avoid||
1817|125|P|contact with people who have recently received live vaccines||
1817|126|P|(such as flu vaccine inhaled through the nose).||
1817|127|P|   Before having surgery, tell your doctor or dentist about all||
1817|128|P|the products you use (including prescription drugs,||
1817|129|P|nonprescription drugs, and herbal products).||
1817|130|P|   During pregnancy, this medication should be used only when||
1817|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
1817|132|P|   It is unknown if this medication passes into breast milk.||
1817|133|P|Consult your doctor before breastfeeding.||
1817|134|B|||
1817|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1817|136|I|medications work or increase your risk for serious side effects.||
1817|137|I|This document does not contain all possible drug interactions.||
1817|138|I|Keep a list of all the products you use (including||
1817|139|I|prescription/nonprescription drugs and herbal products) and share||
1817|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
1817|141|I|the dosage of any medicines without your doctor's approval.||
1817|142|B|||
1817|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1817|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1817|145|O|poison control center right away. US residents can call||
1817|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1817|147|B|||
1817|148|N|NOTES:  Do not share this medication with others.||
1817|149|N|   Lab and/or medical tests (such as complete blood count) should||
1817|150|N|be done while you are using this medication (see also How to Use||
1817|151|N|section). Keep all medical and lab appointments. Consult your||
1817|152|N|doctor for more details.||
1817|153|B|||
1817|154|D|MISSED DOSE:  It is important to get each dose of this medication||
1817|155|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1817|156|D|right away for a new dosing schedule. Do not double the dose to||
1817|157|D|catch up.||
1817|158|B|||
1817|159|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1817|160|R|medication in the original carton to protect from light. This||
1817|161|R|medication may also be stored at room temperature if needed. If||
1817|162|R|the medication is stored at room temperature, do not put it back||
1817|163|R|in the refrigerator and discard after 14 days. Discard any unused||
1817|164|R|portion after use. Keep all medications away from children and||
1817|165|R|pets.||
1817|166|R|   Do not flush medications down the toilet or pour them into a||
1817|167|R|drain unless instructed to do so. Properly discard this product||
1817|168|R|when it is expired or no longer needed. Consult your pharmacist||
1817|169|R|or local waste disposal company.||
1817|170|B|||
1817|171|A|Information last revised April 2025.||
1817|172|A|Copyright(c) 2025 First Databank, Inc.||
1817|173|B|||
1818|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1818|002|Z|does NOT have all possible information about this product. This||
1818|003|Z|information does not assure that this product is safe, effective,||
1818|004|Z|or appropriate for you. This information is not individual||
1818|005|Z|medical advice and does not substitute for the advice of your||
1818|006|Z|health care professional. Always ask your health care||
1818|007|Z|professional for complete information about this product and your||
1818|008|Z|specific health needs.||
1818|009|B|||
1818|010|T|AVELUMAB - INJECTION||
1818|011|F|(a-VEL-ue-mab)||
1818|012|B|||
1818|013|C|COMMON BRAND NAME(S): Bavencio||
1818|014|B|||
1818|015|U|USES:  Avelumab is used to treat various types of cancer. It||
1818|016|U|works by changing the action of your own immune system, directing||
1818|017|U|it to attack cancer cells. Avelumab belongs to a class of drugs||
1818|018|U|known as monoclonal antibodies.||
1818|019|B|||
1818|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1818|021|H|pharmacist before you start receiving avelumab and each time you||
1818|022|H|get a treatment. If you have any questions, ask your doctor or||
1818|023|H|pharmacist.||
1818|024|H|   This medication is given by a health care professional. It is||
1818|025|H|injected slowly into a vein over 60 minutes. It is given as||
1818|026|H|directed by your doctor, usually once every 2 weeks.||
1818|027|H|   Infusion reactions may happen during the infusion of this||
1818|028|H|drug. Your doctor may prescribe other medications (such as||
1818|029|H|diphenhydramine, acetaminophen) before treatment to help prevent||
1818|030|H|these side effects. Tell your doctor right away if you have any||
1818|031|H|symptoms of infusion reactions such as flushing, trouble||
1818|032|H|breathing, fever, chills, hives, abdominal/back pain, or||
1818|033|H|dizziness.||
1818|034|H|   The dosage is based on your medical condition and response to||
1818|035|H|treatment. Your doctor may stop your treatment for some time if||
1818|036|H|you get serious side effects. Your doctor may also prescribe||
1818|037|H|another medication (a corticosteroid such as prednisone) to help||
1818|038|H|treat side effects of this medication.||
1818|039|H|   To get the most benefit, do not miss any doses. To help you||
1818|040|H|remember, mark your calendar with a reminder.||
1818|041|B|||
1818|042|S|SIDE EFFECTS:  See also How to Use section.||
1818|043|S|   Tiredness, diarrhea, nausea, vomiting, cough, decreased||
1818|044|S|appetite, or dizziness may occur. If any of these effects lasts||
1818|045|S|or gets worse, tell your doctor or pharmacist promptly.||
1818|046|S|   People using this medication may have serious side effects.||
1818|047|S|However, you have been prescribed this drug because your doctor||
1818|048|S|has judged that the benefit to you is greater than the risk of||
1818|049|S|side effects. Careful monitoring by your doctor may decrease your||
1818|050|S|risk.||
1818|051|S|   Tell your doctor right away if you have any serious side||
1818|052|S|effects, including: new/worsening cough, diarrhea with||
1818|053|S|blood/mucus, mouth/throat sores, severe stomach/abdominal pain,||
1818|054|S|bloody/black/tarry stool, symptoms of liver disease (such as||
1818|055|S|nausea/vomiting that doesn't stop, loss of appetite, yellowing||
1818|056|S|eyes/skin, dark urine), signs of kidney problems (such as change||
1818|057|S|in the amount of urine, pink/bloody urine), easy||
1818|058|S|bruising/bleeding, swelling hands/ankles/feet, unusual weakness,||
1818|059|S|joint stiffness/pain, muscle weakness/pain, numbness/tingling of||
1818|060|S|arms/legs, eye redness/pain, sensitivity to light, vision||
1818|061|S|changes.||
1818|062|S|   Avelumab may cause hormone gland problems (such as thyroid,||
1818|063|S|pituitary, adrenal, pancreas). Your body could make too much or||
1818|064|S|too little hormone. Tell your doctor right away if you have any||
1818|065|S|symptoms such as: cold or heat intolerance, unexplained weight||
1818|066|S|loss/gain, increased thirst/urination, mood or behavior changes||
1818|067|S|(such as decreased sex drive, irritability, forgetfulness),||
1818|068|S|slow/fast/pounding/irregular heartbeat, unusual tiredness,||
1818|069|S|constipation.||
1818|070|S|   Get medical help right away if you have any very serious side||
1818|071|S|effects, including: chest pain, shortness of breath.||
1818|072|S|   Avelumab can commonly cause itching or a rash that is usually||
1818|073|S|not serious. However, you may not be able to tell it apart from a||
1818|074|S|rare rash that could be a sign of a severe reaction. Get medical||
1818|075|S|help right away if you develop any rash or itching.||
1818|076|S|   A very serious allergic reaction to this drug is rare.||
1818|077|S|However, get medical help right away if you notice any symptoms||
1818|078|S|of a serious allergic reaction, including: fever, swollen lymph||
1818|079|S|nodes, rash, itching/swelling (especially of the||
1818|080|S|face/tongue/throat), severe dizziness, trouble breathing.||
1818|081|S|   This is not a complete list of possible side effects. If you||
1818|082|S|notice other effects not listed above, contact your doctor or||
1818|083|S|pharmacist.||
1818|084|S|   In the US -||
1818|085|S|   Call your doctor for medical advice about side effects. You||
1818|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1818|087|S|www.fda.gov/medwatch.||
1818|088|S|   In Canada - Call your doctor for medical advice about side||
1818|089|S|effects. You may report side effects to Health Canada at||
1818|090|S|1-866-234-2345.||
1818|091|B|||
1818|092|P|PRECAUTIONS:  Before using avelumab, tell your doctor or||
1818|093|P|pharmacist if you are allergic to it; or if you have any other||
1818|094|P|allergies. This product may contain inactive ingredients, which||
1818|095|P|can cause allergic reactions or other problems. Talk to your||
1818|096|P|pharmacist for more details.||
1818|097|P|   Before using this medication, tell your doctor or pharmacist||
1818|098|P|your medical history, especially of: organ transplant, stem cell||
1818|099|P|transplant with donor cells.||
1818|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1818|101|P|can make you more dizzy. Do not drive, use machinery, or do||
1818|102|P|anything that needs alertness until you can do it safely. Limit||
1818|103|P|alcoholic beverages. Talk to your doctor if you are using||
1818|104|P|marijuana (cannabis).||
1818|105|P|   Before having surgery, tell your doctor or dentist about all||
1818|106|P|the products you use (including prescription drugs,||
1818|107|P|nonprescription drugs, and herbal products).||
1818|108|P|   Tell your doctor if you are pregnant or plan to become||
1818|109|P|pregnant. You should not become pregnant while using avelumab.||
1818|110|P|Avelumab may harm an unborn baby. Ask about reliable forms of||
1818|111|P|birth control while using this medication and for 1 month after||
1818|112|P|the last dose. If you become pregnant, talk to your doctor right||
1818|113|P|away about the risks and benefits of this medication.||
1818|114|P|   It is unknown if this drug passes into breast milk. Because of||
1818|115|P|the possible risk to the infant, breastfeeding is not recommended||
1818|116|P|while using this drug and for 1 month after the last dose.||
1818|117|P|Consult your doctor before breastfeeding.||
1818|118|B|||
1818|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1818|120|I|medications work or increase your risk for serious side effects.||
1818|121|I|This document does not contain all possible drug interactions.||
1818|122|I|Keep a list of all the products you use (including||
1818|123|I|prescription/nonprescription drugs and herbal products) and share||
1818|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
1818|125|I|the dosage of any medicines without your doctor's approval.||
1818|126|B|||
1818|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1818|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1818|129|O|poison control center right away. US residents can call||
1818|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1818|131|B|||
1818|132|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
1818|133|N|function, blood sugar) should be done before and during treatment||
1818|134|N|with this medication. Keep all medical and lab appointments.||
1818|135|N|Consult your doctor for more details.||
1818|136|B|||
1818|137|D|MISSED DOSE:  It is important to get each dose of this medication||
1818|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1818|139|D|right away for a new dosing schedule.||
1818|140|B|||
1818|141|R|STORAGE:  Not applicable. This medication is given in a hospital||
1818|142|R|or clinic and will not be stored at home.||
1818|143|B|||
1818|144|A|Information last revised October 2024.||
1818|145|A|Copyright(c) 2025 First Databank, Inc.||
1818|146|B|||
1819|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1819|002|Z|does NOT have all possible information about this product. This||
1819|003|Z|information does not assure that this product is safe, effective,||
1819|004|Z|or appropriate for you. This information is not individual||
1819|005|Z|medical advice and does not substitute for the advice of your||
1819|006|Z|health care professional. Always ask your health care||
1819|007|Z|professional for complete information about this product and your||
1819|008|Z|specific health needs.||
1819|009|B|||
1819|010|T|EMPAGLIFLOZIN/METFORMIN EXTENDED-RELEASE - ORAL||
1819|011|F|(EM-pa-gli-FLOE-zin/met-FOR-min)||
1819|012|B|||
1819|013|C|COMMON BRAND NAME(S): Synjardy XR||
1819|014|B|||
1819|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1819|016|W|cause a serious (sometimes fatal) condition called lactic||
1819|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1819|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1819|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1819|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1819|021|W|you are using certain drugs. For some conditions, your doctor may||
1819|022|W|tell you to stop taking this medication for a short time. Ask||
1819|023|W|your doctor or pharmacist for more details.||
1819|024|W|   Stop taking this medication and get medical help right away if||
1819|025|W|you have any symptoms of lactic acidosis, such as unusual||
1819|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1819|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1819|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1819|029|B|||
1819|030|U|USES:  This medication is a combination of 2 drugs: empagliflozin||
1819|031|U|and metformin. It is used with a proper diet and exercise program||
1819|032|U|to control high blood sugar in people with type 2 diabetes.||
1819|033|U|Controlling high blood sugar helps prevent kidney damage,||
1819|034|U|blindness, nerve problems, loss of limbs, and sexual function||
1819|035|U|problems. Proper control of diabetes may also lessen your risk of||
1819|036|U|a heart attack or stroke. This medication is also used to treat||
1819|037|U|heart failure or long-term kidney disease in people with type 2||
1819|038|U|diabetes. It may help lower the risk of death from heart disease||
1819|039|U|and reduce the need to go to a hospital to treat heart failure or||
1819|040|U|kidney disease. In people with long-term kidney disease, this||
1819|041|U|medication may also help slow down the worsening of kidney||
1819|042|U|disease.||
1819|043|U|   This medication works by helping to restore your body's proper||
1819|044|U|response to the insulin you naturally produce. It also increases||
1819|045|U|the removal of sugar by your kidneys, decreases how much sugar is||
1819|046|U|made in your liver, and decreases how much sugar your body takes||
1819|047|U|in through your stomach and intestines.||
1819|048|B|||
1819|049|H|HOW TO USE:  Read the Medication Guide provided by your||
1819|050|H|pharmacist before you start taking this medication and each time||
1819|051|H|you get a refill. If you have any questions, ask your doctor or||
1819|052|H|pharmacist.||
1819|053|H|   Take this medication by mouth as directed by your doctor,||
1819|054|H|usually once daily with the morning meal. Swallow the tablets||
1819|055|H|whole. Do not crush, dissolve, or chew the tablets. Doing so can||
1819|056|H|release all of the drug at once, increasing the risk of side||
1819|057|H|effects. Take this medication regularly to get the most benefit||
1819|058|H|from it. To help you remember, take it at the same time each day.||
1819|059|H|Drink plenty of fluids while taking this medication unless||
1819|060|H|otherwise directed by your doctor.||
1819|061|H|   The dosage is based on your medical condition, response to||
1819|062|H|treatment, and other medications you may be taking. Be sure to||
1819|063|H|tell your doctor and pharmacist about all the products you use||
1819|064|H|(including prescription drugs, nonprescription drugs, and herbal||
1819|065|H|products). To reduce your risk of side effects (such as diarrhea,||
1819|066|H|nausea), your doctor may direct you to start this medication at a||
1819|067|H|low dose and gradually increase your dose. Follow your doctor's||
1819|068|H|instructions carefully.||
1819|069|H|   Tell your doctor if your condition does not get better or if||
1819|070|H|it gets worse (your blood sugar is too high or too low).||
1819|071|B|||
1819|072|S|SIDE EFFECTS:  See also Warning section.||
1819|073|S|   Nausea, vomiting, stomach upset, diarrhea, bloating/gas,||
1819|074|S|headache, or weakness may occur. If any of these effects last or||
1819|075|S|get worse, tell your doctor or pharmacist promptly. If stomach||
1819|076|S|symptoms return later (after taking the same dose for several||
1819|077|S|days or weeks), tell your doctor right away. Stomach symptoms||
1819|078|S|that occur after the first days of your treatment may be signs of||
1819|079|S|lactic acidosis.||
1819|080|S|   Tell your doctor if you see undissolved tablets in your stool.||
1819|081|S|Your doctor may check lab tests to make sure the medication is||
1819|082|S|working.||
1819|083|S|   Remember that this medication has been prescribed because your||
1819|084|S|doctor has judged that the benefit to you is greater than the||
1819|085|S|risk of side effects. Many people using this medication do not||
1819|086|S|have serious side effects.||
1819|087|S|   Tell your doctor right away if you have any serious side||
1819|088|S|effects, including: signs of a urinary tract infection (such as||
1819|089|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1819|090|S|signs of new or worsening kidney problems (such as change in the||
1819|091|S|amount of urine).||
1819|092|S|   This medication may cause a new yeast infection in the vagina||
1819|093|S|or the penis. It may also cause a rare but very serious bacterial||
1819|094|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1819|095|S|your doctor right away if you have signs of a yeast infection in||
1819|096|S|the vagina (such as unusual vaginal||
1819|097|S|discharge/burning/itching/odor) or in the penis (such as||
1819|098|S|redness/itching/swelling of the penis, unusual discharge from the||
1819|099|S|penis). However, get medical help right away if you have any||
1819|100|S|pain/redness/swelling in or around the genital/anal area, along||
1819|101|S|with a fever or feeling unwell.||
1819|102|S|   This medication may increase the risk of lower limb amputation||
1819|103|S|(especially of the toe and foot). The risk is higher if you have||
1819|104|S|poor blood flow in the legs, nerve problems, foot ulcers, or have||
1819|105|S|had a previous amputation. To lessen the risk, check your feet||
1819|106|S|regularly and tell your doctor if you have new pain, tenderness,||
1819|107|S|sores, or ulcers on your legs or feet.||
1819|108|S|   This medication does not usually cause low blood sugar||
1819|109|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1819|110|S|prescribed with other diabetes medications, or if you do not get||
1819|111|S|enough calories from food, or if you do unusually heavy exercise.||
1819|112|S|Talk with your doctor or pharmacist about whether the dose of||
1819|113|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1819|114|S|of low blood sugar include sudden sweating, shaking, fast||
1819|115|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1819|116|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1819|117|S|treat low blood sugar. If you don't have these reliable forms of||
1819|118|S|glucose, rapidly raise your blood sugar by eating a quick source||
1819|119|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1819|120|S|juice or non-diet soda. Tell your doctor right away about the||
1819|121|S|reaction and the use of this product. To help prevent low blood||
1819|122|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1819|123|S|Check with your doctor or pharmacist to find out what you should||
1819|124|S|do if you miss a meal.||
1819|125|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1819|126|S|thirst/urination. If these symptoms occur, tell your doctor right||
1819|127|S|away. Your doctor may need to adjust your diabetes medication,||
1819|128|S|exercise program, or diet.||
1819|129|S|   This medication may cause you to become dehydrated. This can||
1819|130|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1819|131|S|dehydration. Tell your doctor or pharmacist right away if you are||
1819|132|S|not able to drink fluids as usual, or losing fluid (such as due||
1819|133|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1819|134|S|right away if you have any signs of dehydration, such as||
1819|135|S|urinating less than usual, unusual dry mouth/thirst, fast||
1819|136|S|heartbeat, or dizziness/lightheadedness/fainting. To reduce the||
1819|137|S|risk of dizziness and lightheadedness, get up slowly when rising||
1819|138|S|from a sitting or lying position.||
1819|139|S|   A very serious allergic reaction to this drug is rare.||
1819|140|S|However, get medical help right away if you notice any symptoms||
1819|141|S|of a serious allergic reaction, including: rash, itching/swelling||
1819|142|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1819|143|S|breathing.||
1819|144|S|   This is not a complete list of possible side effects. If you||
1819|145|S|notice other effects not listed above, contact your doctor or||
1819|146|S|pharmacist.||
1819|147|S|   In the US -||
1819|148|S|   Call your doctor for medical advice about side effects. You||
1819|149|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1819|150|S|www.fda.gov/medwatch.||
1819|151|S|   In Canada - Call your doctor for medical advice about side||
1819|152|S|effects. You may report side effects to Health Canada at||
1819|153|S|1-866-234-2345.||
1819|154|B|||
1819|155|P|PRECAUTIONS:  See also Warning section.||
1819|156|P|   Before taking this medication, tell your doctor or pharmacist||
1819|157|P|if you are allergic to empagliflozin or metformin; or if you have||
1819|158|P|any other allergies. This product may contain inactive||
1819|159|P|ingredients, which can cause allergic reactions or other||
1819|160|P|problems. Talk to your pharmacist for more details.||
1819|161|P|   Before using this medication, tell your doctor or pharmacist||
1819|162|P|your medical history, especially of: breathing problems (such as||
1819|163|P|asthma, obstructive lung disease), blood problems (such as||
1819|164|P|anemia, vitamin B12 deficiency), dehydration, heart disease (such||
1819|165|P|as heart failure, recent heart attack), kidney disease, liver||
1819|166|P|problems, disease of the pancreas (pancreatitis), use/abuse of||
1819|167|P|alcohol, yeast infections in the vagina or penis, blocked or||
1819|168|P|narrowed blood vessels, usually in the leg, nerve problems (such||
1819|169|P|as diabetic peripheral neuropathy), foot sores or ulcers,||
1819|170|P|amputation.||
1819|171|P|   You may experience blurred vision, dizziness, or drowsiness||
1819|172|P|due to extremely low or high blood sugar. Do not drive, use||
1819|173|P|machinery, or do anything that needs alertness or clear vision||
1819|174|P|until you can do it safely.||
1819|175|P|   Limit alcohol while using this medication because it can||
1819|176|P|increase your risk of developing lactic acidosis, low blood||
1819|177|P|sugar, or a high ketone level.||
1819|178|P|   High fever, "water pills" (diuretics such as||
1819|179|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1819|180|P|may cause dehydration and increase your risk of lactic acidosis.||
1819|181|P|Stop taking this medication and tell your doctor right away if||
1819|182|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1819|183|P|fluids to prevent dehydration unless your doctor directs you||
1819|184|P|otherwise.||
1819|185|P|   It may be harder to control your blood sugar when your body is||
1819|186|P|stressed (such as due to fever, infection, injury, or surgery).||
1819|187|P|Also, if you are eating less or not able to eat due to these||
1819|188|P|conditions or any illness, this can lead to a high ketone level||
1819|189|P|while you are taking this medication. Consult your doctor because||
1819|190|P|this may require a change in your treatment plan, medications, or||
1819|191|P|blood sugar or ketone testing.||
1819|192|P|   Before having surgery or any X-ray/scanning procedure using||
1819|193|P|iodinated contrast, tell your doctor or dentist about all the||
1819|194|P|products you use (including prescription drugs, nonprescription||
1819|195|P|drugs, and herbal products). You may need to stop this medication||
1819|196|P|for a short time for the surgery/procedure. Ask your doctor or||
1819|197|P|dentist for instructions before your surgery/procedure.||
1819|198|P|   Older adults may be at greater risk for side effects such as||
1819|199|P|low blood sugar, dehydration, lactic acidosis, kidney problems,||
1819|200|P|and low blood pressure.||
1819|201|P|   During pregnancy, this medication should be used only when||
1819|202|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1819|203|P|benefits with your doctor.||
1819|204|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1819|205|P|your doctor for managing your blood sugar while pregnant. Your||
1819|206|P|doctor may change your diabetes treatment during your pregnancy||
1819|207|P|(such as diet and medications including insulin).||
1819|208|P|   Metformin can cause changes in the menstrual cycle (promote||
1819|209|P|ovulation) and increase the risk of becoming pregnant. Consult||
1819|210|P|your doctor or pharmacist about the use of reliable birth control||
1819|211|P|while using this medication.||
1819|212|P|   Metformin passes into breast milk in small amounts. It is||
1819|213|P|unknown if empagliflozin passes into breast milk. Consult your||
1819|214|P|doctor before breastfeeding.||
1819|215|B|||
1819|216|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1819|217|I|medications work or increase your risk for serious side effects.||
1819|218|I|This document does not contain all possible drug interactions.||
1819|219|I|Keep a list of all the products you use (including||
1819|220|I|prescription/nonprescription drugs and herbal products) and share||
1819|221|I|it with your doctor and pharmacist. Do not start, stop, or change||
1819|222|I|the dosage of any medicines without your doctor's approval.||
1819|223|I|   Beta blocker medications (such as metoprolol, propranolol,||
1819|224|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1819|225|I|heartbeat you would usually feel when your blood sugar falls too||
1819|226|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1819|227|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1819|228|I|   Many drugs can affect your blood sugar, making it harder to||
1819|229|I|control. Before you start, stop, or change any medication, talk||
1819|230|I|with your doctor or pharmacist about how the medication may||
1819|231|I|affect your blood sugar. Check your blood sugar regularly as||
1819|232|I|directed by your doctor. Tell your doctor about the results and||
1819|233|I|of any symptoms of high or low blood sugar. (See also Side||
1819|234|I|Effects section.) Your doctor may need to adjust your diabetes||
1819|235|I|medication, exercise program, or diet.||
1819|236|I|   Your urine will test positive for glucose. Make sure lab||
1819|237|I|personnel and all your doctors know you use this drug.||
1819|238|B|||
1819|239|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1819|240|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1819|241|O|poison control center right away. US residents can call||
1819|242|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1819|243|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
1819|244|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
1819|245|O|rapid breathing, slow/irregular heartbeat.||
1819|246|B|||
1819|247|N|NOTES:  Do not share this medication with others.||
1819|248|N|   Attend a diabetes education program to learn more about how to||
1819|249|N|manage your diabetes with medications, diet, exercise, and||
1819|250|N|regular medical exams.||
1819|251|N|   Learn the symptoms of high and low blood sugar and how to||
1819|252|N|treat low blood sugar. Check your blood sugar regularly as||
1819|253|N|directed.||
1819|254|N|   Lab and/or medical tests (such as kidney/liver function, blood||
1819|255|N|sugar, hemoglobin A1c, complete blood counts, cholesterol,||
1819|256|N|vitamin B12) should be done before you start taking this||
1819|257|N|medication and while you are taking it. Keep all medical and lab||
1819|258|N|appointments. Consult your doctor for more details.||
1819|259|B|||
1819|260|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1819|261|D|remember. If it is near the time of the next dose, skip the||
1819|262|D|missed dose. Take your next dose at the regular time. Do not||
1819|263|D|double the dose to catch up.||
1819|264|B|||
1819|265|R|STORAGE:  Store at room temperature away from light and moisture.||
1819|266|R|Do not store in the bathroom. Keep all medications away from||
1819|267|R|children and pets.||
1819|268|R|   Do not flush medications down the toilet or pour them into a||
1819|269|R|drain unless instructed to do so. Properly discard this product||
1819|270|R|when it is expired or no longer needed. Consult your pharmacist||
1819|271|R|or local waste disposal company.||
1819|272|B|||
1819|273|M|MEDICAL ALERT:  Your condition can cause complications in a||
1819|274|M|medical emergency. For information about enrolling in MedicAlert,||
1819|275|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1819|276|B|||
1819|277|A|Information last revised May 2025.||
1819|278|A|Copyright(c) 2025 First Databank, Inc.||
1819|279|B|||
1820|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1820|002|Z|does NOT have all possible information about this product. This||
1820|003|Z|information does not assure that this product is safe, effective,||
1820|004|Z|or appropriate for you. This information is not individual||
1820|005|Z|medical advice and does not substitute for the advice of your||
1820|006|Z|health care professional. Always ask your health care||
1820|007|Z|professional for complete information about this product and your||
1820|008|Z|specific health needs.||
1820|009|B|||
1820|010|T|SARILUMAB - SUBCUTANEOUS INJECTION||
1820|011|F|(sar-IL-ue-mab)||
1820|012|B|||
1820|013|C|COMMON BRAND NAME(S): Kevzara||
1820|014|B|||
1820|015|W|WARNING:  This medication may lower your ability to fight an||
1820|016|W|infection. This may make you more likely to get a serious (rarely||
1820|017|W|fatal) infection or make any infection you have worse. Your risk||
1820|018|W|may be increased if you are also taking other drugs that can||
1820|019|W|lower your ability to fight an infection (such as methotrexate or||
1820|020|W|corticosteroids). Before using sarilumab, tell your doctor your||
1820|021|W|medical history, especially of any kind of infection. During||
1820|022|W|treatment, tell your doctor right away if you develop any signs||
1820|023|W|of infection (such as sore throat that doesn't go away, fever,||
1820|024|W|chills, painful urination).||
1820|025|W|   Before and during treatment with this medication, your doctor||
1820|026|W|will test you for tuberculosis (TB). If needed, treatment for||
1820|027|W|tuberculosis or other infections should be done before receiving||
1820|028|W|this medication.||
1820|029|B|||
1820|030|U|USES:  This medication is used to treat rheumatoid arthritis,||
1820|031|U|polyarticular juvenile idiopathic arthritis (pJIA), or||
1820|032|U|polymyalgia rheumatica (PMR). Sarilumab belongs to a class of||
1820|033|U|drugs known as monoclonal antibodies. It helps reduce pain and||
1820|034|U|swelling by blocking Interleukin-6, a substance made by the body||
1820|035|U|that causes swelling (inflammation).||
1820|036|B|||
1820|037|V|OTHER USES:  This section contains uses of this drug that are not||
1820|038|V|listed in the approved professional labeling for the drug but||
1820|039|V|that may be prescribed by your health care professional. Use this||
1820|040|V|drug for a condition that is listed in this section only if it||
1820|041|V|has been so prescribed by your health care professional.||
1820|042|V|   This medication may also be used for COVID-19, but is only||
1820|043|V|effective in hospitalized patients who need supplemental oxygen||
1820|044|V|or a mechanical ventilator to breathe.||
1820|045|B|||
1820|046|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1820|047|H|provided by your pharmacist before you start using sarilumab and||
1820|048|H|each time you get a refill. Ask your health care professional how||
1820|049|H|to prepare and use this medication. If you have any questions,||
1820|050|H|ask your doctor or pharmacist.||
1820|051|H|   Inject this medication under the skin as directed by your||
1820|052|H|doctor, usually once every 2 weeks. The injection is given in the||
1820|053|H|thigh, abdomen, or upper arm. The dosage is based on your medical||
1820|054|H|condition, labs, and response to treatment.||
1820|055|H|   Depending on your product, take the medication out of the||
1820|056|H|refrigerator 30 or 60 minutes before you inject it to allow it to||
1820|057|H|reach room temperature. Do not warm up this medication any other||
1820|058|H|way (for example, do not heat it in the microwave or place it in||
1820|059|H|hot water). Before using, check this product for particles or||
1820|060|H|discoloration. If either is present, do not use the liquid.||
1820|061|H|Before injecting each dose, clean the skin you are going to||
1820|062|H|inject into (the injection site) with rubbing alcohol. Change the||
1820|063|H|injection site each time to lessen injury under the skin. Do not||
1820|064|H|inject into skin that is tender, damaged, or has bruises or||
1820|065|H|scars. To lessen bruising, do not rub the injection site after a||
1820|066|H|shot. Learn how to store and discard medical supplies safely.||
1820|067|H|   Use this medication regularly to get the most benefit from it.||
1820|068|H|To help you remember, mark your calendar with a reminder.||
1820|069|H|   Tell your doctor if your condition does not get better or if||
1820|070|H|it gets worse.||
1820|071|B|||
1820|072|S|SIDE EFFECTS:  See also Warning section.||
1820|073|S|   Irritation, redness, or pain at the injection site may occur.||
1820|074|S|If any of these effects last or get worse, tell your doctor or||
1820|075|S|pharmacist promptly.||
1820|076|S|   Remember that this medication has been prescribed because your||
1820|077|S|doctor has judged that the benefit to you is greater than the||
1820|078|S|risk of side effects. Many people using this medication do not||
1820|079|S|have serious side effects.||
1820|080|S|   Tell your doctor right away if you have any serious side||
1820|081|S|effects, including: severe stomach/abdominal pain.||
1820|082|S|   A very serious allergic reaction to this drug is rare.||
1820|083|S|However, get medical help right away if you notice any symptoms||
1820|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1820|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1820|086|S|breathing.||
1820|087|S|   This is not a complete list of possible side effects. If you||
1820|088|S|notice other effects not listed above, contact your doctor or||
1820|089|S|pharmacist.||
1820|090|S|   In the US -||
1820|091|S|   Call your doctor for medical advice about side effects. You||
1820|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1820|093|S|www.fda.gov/medwatch.||
1820|094|S|   In Canada - Call your doctor for medical advice about side||
1820|095|S|effects. You may report side effects to Health Canada at||
1820|096|S|1-866-234-2345.||
1820|097|B|||
1820|098|P|PRECAUTIONS:  Before using sarilumab, tell your doctor or||
1820|099|P|pharmacist if you are allergic to it; or if you have any other||
1820|100|P|allergies. This product may contain inactive ingredients, which||
1820|101|P|can cause allergic reactions or other problems. Talk to your||
1820|102|P|pharmacist for more details.||
1820|103|P|   Before using this medication, tell your doctor or pharmacist||
1820|104|P|your medical history, especially of: diabetes,||
1820|105|P|past/current/returning infections, liver problems, blood/bleeding||
1820|106|P|problems, stomach/abdominal problems (such as ulcers,||
1820|107|P|diverticulitis).||
1820|108|P|   Sarilumab can make you more likely to get infections or may||
1820|109|P|make current infections worse. Stay away from anyone who has an||
1820|110|P|infection that may easily spread (such as chickenpox, COVID-19,||
1820|111|P|measles, tuberculosis, flu). Tell your doctor if you live in,||
1820|112|P|have lived in, or have traveled to certain areas where there is||
1820|113|P|an increased chance of getting certain kinds of fungal infections||
1820|114|P|(blastomycosis, coccidioidomycosis, histoplasmosis). Talk to your||
1820|115|P|doctor if you have been exposed to an infection or for more||
1820|116|P|details.||
1820|117|P|   Tell your health care professional that you are using||
1820|118|P|sarilumab before having any immunizations/vaccinations. Avoid||
1820|119|P|contact with people who have recently received live vaccines||
1820|120|P|(such as flu vaccine inhaled through the nose).||
1820|121|P|   Drugs that affect the immune system (such as sarilumab) may||
1820|122|P|increase your risk of certain cancers. Tell your doctor if you||
1820|123|P|have ever had any type of cancer.||
1820|124|P|   Before having surgery, tell your doctor or dentist about all||
1820|125|P|the products you use (including prescription drugs,||
1820|126|P|nonprescription drugs, and herbal products).||
1820|127|P|   During pregnancy, this medication should be used only when||
1820|128|P|clearly needed. Discuss the risks and benefits with your doctor.||
1820|129|P|   It is unknown if this drug passes into breast milk. Consult||
1820|130|P|your doctor before breastfeeding.||
1820|131|B|||
1820|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1820|133|I|medications work or increase your risk for serious side effects.||
1820|134|I|This document does not contain all possible drug interactions.||
1820|135|I|Keep a list of all the products you use (including||
1820|136|I|prescription/nonprescription drugs and herbal products) and share||
1820|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
1820|138|I|the dosage of any medicines without your doctor's approval.||
1820|139|I|   This medication can speed up the removal of other medications||
1820|140|I|from your body, which may affect how they work. Examples of||
1820|141|I|affected drugs include warfarin, some cholesterol drugs such as||
1820|142|I|atorvastatin/lovastatin/simvastatin, among others.||
1820|143|I|   This medication may decrease the effectiveness of hormonal||
1820|144|I|birth control such as pills, patch, or ring. This could cause||
1820|145|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1820|146|I|use reliable backup birth control methods while using this||
1820|147|I|medication. Also tell your doctor if you have any new spotting or||
1820|148|I|breakthrough bleeding, because these may be signs that your birth||
1820|149|I|control is not working well.||
1820|150|B|||
1820|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1820|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1820|153|O|poison control center right away. US residents can call||
1820|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1820|155|B|||
1820|156|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
1820|157|N|liver function, cholesterol tests) should be done before you||
1820|158|N|start using this medication and while you are using it. Keep all||
1820|159|N|medical and lab appointments.||
1820|160|B|||
1820|161|D|MISSED DOSE:  If you miss a dose and it has been 3 days or less||
1820|162|D|since the missed dose, use it as soon as you remember. Use your||
1820|163|D|next dose at the regular time. Do not double the dose to catch||
1820|164|D|up. If it has been 4 days or longer, ask your doctor or||
1820|165|D|pharmacist right away for a new dosing schedule.||
1820|166|B|||
1820|167|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1820|168|R|medication in the original package to protect from light. This||
1820|169|R|medication may also be stored at room temperature if needed. If||
1820|170|R|the medication is stored at room temperature, discard after 14||
1820|171|R|days. Keep all medications away from children and pets.||
1820|172|R|   Do not flush medications down the toilet or pour them into a||
1820|173|R|drain unless instructed to do so. Properly discard this product||
1820|174|R|when it is expired or no longer needed. Consult your pharmacist||
1820|175|R|or local waste disposal company.||
1820|176|B|||
1820|177|A|Information last revised April 2025.||
1820|178|A|Copyright(c) 2025 First Databank, Inc.||
1820|179|B|||
1821|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1821|002|Z|does NOT have all possible information about this product. This||
1821|003|Z|information does not assure that this product is safe, effective,||
1821|004|Z|or appropriate for you. This information is not individual||
1821|005|Z|medical advice and does not substitute for the advice of your||
1821|006|Z|health care professional. Always ask your health care||
1821|007|Z|professional for complete information about this product and your||
1821|008|Z|specific health needs.||
1821|009|B|||
1821|010|T|DEUTETRABENAZINE - ORAL||
1821|011|F|(DU-tet-ra-BEN-a-zeen)||
1821|012|B|||
1821|013|C|COMMON BRAND NAME(S): Austedo||
1821|014|B|||
1821|015|W|WARNING:  If you have Huntington's disease, deutetrabenazine can||
1821|016|W|sometimes increase the risk of depression and suicidal||
1821|017|W|thoughts/attempts. People with Huntington's disease are already||
1821|018|W|more likely to have depression and suicidal thoughts/attempts.||
1821|019|W|Talk with your doctor about the risks and benefits of this||
1821|020|W|medication. People with Huntington's disease and depression must||
1821|021|W|not use deutetrabenazine if they are not being treated for||
1821|022|W|depression or if they still have symptoms of depression with||
1821|023|W|medication/treatment. Tell your doctor right away if you or your||
1821|024|W|family/caregivers notice that you have new/worsening symptoms of||
1821|025|W|depression, sadness, loss of interest in activities you used to||
1821|026|W|enjoy, suicidal thoughts/attempts, or other mental/mood/behavior||
1821|027|W|changes (such as new/worsening anxiety, panic attacks, trouble||
1821|028|W|sleeping, irritability, hostile/angry feelings).||
1821|029|B|||
1821|030|U|USES:  Deutetrabenazine is used to decrease involuntary movements||
1821|031|U|(chorea) caused by Huntington's disease. It is also used to treat||
1821|032|U|involuntary movements of the face, tongue, or other body parts||
1821|033|U|(tardive dyskinesia). Reducing involuntary movements will help||
1821|034|U|you take part in more of your normal daily activities. This||
1821|035|U|medication is thought to work by decreasing the amount of certain||
1821|036|U|natural substances in the brain that affect how your nerves and||
1821|037|U|muscles work (monoamines such as dopamine, serotonin, and||
1821|038|U|norepinephrine).||
1821|039|B|||
1821|040|H|HOW TO USE:  Read the Medication Guide provided by your||
1821|041|H|pharmacist before you start using deutetrabenazine and each time||
1821|042|H|you get a refill. If you have any questions, ask your doctor or||
1821|043|H|pharmacist.||
1821|044|H|   Take this medication by mouth with food as directed by your||
1821|045|H|doctor, usually once or twice a day. The manufacturer directs not||
1821|046|H|to chew, crush or break the tablet before taking it. However,||
1821|047|H|many similar drugs (immediate-release tablets) can be chewed,||
1821|048|H|crushed or split. To reduce your risk of side effects, your||
1821|049|H|doctor may direct you to start this medication at a low dose and||
1821|050|H|gradually increase your dose. Follow your doctor's instructions||
1821|051|H|carefully.||
1821|052|H|   The dosage is based on your medical condition, response to||
1821|053|H|treatment, and other medications you may be taking. Be sure to||
1821|054|H|tell your doctor and pharmacist about all the products you use||
1821|055|H|(including prescription drugs, nonprescription drugs, and herbal||
1821|056|H|products).||
1821|057|H|   Use this medication regularly to get the most benefit from it.||
1821|058|H|To help you remember, take it at the same time(s) each day. If||
1821|059|H|you stop taking this medication for more than 1 week, do not take||
1821|060|H|another dose until you talk to your doctor. You may need to||
1821|061|H|restart your medication at a lower dose.||
1821|062|H|   Tell your doctor if you do not get better or if you get worse.||
1821|063|B|||
1821|064|S|SIDE EFFECTS:  See also Warning section.||
1821|065|S|   Drowsiness, trouble sleeping, tiredness, dizziness, nausea, or||
1821|066|S|vomiting may occur. If any of these effects last or get worse,||
1821|067|S|tell your doctor or pharmacist promptly. Your doctor may need to||
1821|068|S|adjust your dose to reduce these side effects.||
1821|069|S|   To reduce the risk of dizziness and lightheadedness, get up||
1821|070|S|slowly when rising from a sitting or lying position.||
1821|071|S|   Remember that this medication has been prescribed because your||
1821|072|S|doctor has judged that the benefit to you is greater than the||
1821|073|S|risk of side effects. Many people using this medication do not||
1821|074|S|have serious side effects.||
1821|075|S|   Tell your doctor right away if you have any serious side||
1821|076|S|effects, including: agitation/restlessness, Parkinson's disease||
1821|077|S|symptoms (such as shaking/tremors, slowed movement, loss of||
1821|078|S|balance).||
1821|079|S|   Sometimes deutetrabenazine can cause side effects that are||
1821|080|S|similar to the symptoms of worsening Huntington's disease. Your||
1821|081|S|doctor may need to adjust your dose to see if these side effects||
1821|082|S|are due to the drug or to the disease. Tell your doctor right||
1821|083|S|away if any of these serious side effects occur: mental/mood||
1821|084|S|changes (such as new/worsening depression, suicidal||
1821|085|S|thoughts/attempts, problems with thinking), trouble swallowing,||
1821|086|S|uncontrolled muscle movements of the face (such as lip smacking,||
1821|087|S|unusual tongue movements), signs of increased prolactin hormone||
1821|088|S|(such as enlarged breasts, abnormal breast milk production,||
1821|089|S|decreased sexual ability, a change in menstrual cycle).||
1821|090|S|   This medication may rarely cause a very serious condition||
1821|091|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1821|092|S|right away if you have any of the following symptoms: fever,||
1821|093|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1821|094|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1821|095|S|signs of kidney problems (such as change in the amount of urine).||
1821|096|S|   A very serious allergic reaction to this drug is rare.||
1821|097|S|However, get medical help right away if you notice any symptoms||
1821|098|S|of a serious allergic reaction, including: rash, itching/swelling||
1821|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1821|100|S|breathing.||
1821|101|S|   This is not a complete list of possible side effects. If you||
1821|102|S|notice other effects not listed above, contact your doctor or||
1821|103|S|pharmacist.||
1821|104|S|   In the US -||
1821|105|S|   Call your doctor for medical advice about side effects. You||
1821|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1821|107|S|www.fda.gov/medwatch.||
1821|108|S|   In Canada - Call your doctor for medical advice about side||
1821|109|S|effects. You may report side effects to Health Canada at||
1821|110|S|1-866-234-2345.||
1821|111|B|||
1821|112|P|PRECAUTIONS:  See also Warning section.||
1821|113|P|   Before taking deutetrabenazine, tell your doctor or pharmacist||
1821|114|P|if you are allergic to it; or to tetrabenazine; or if you have||
1821|115|P|any other allergies. This product may contain inactive||
1821|116|P|ingredients, which can cause allergic reactions or other||
1821|117|P|problems. Talk to your pharmacist for more details.||
1821|118|P|   Before using this medication, tell your doctor or pharmacist||
1821|119|P|your medical history, especially of: breast cancer, liver||
1821|120|P|problems, certain heart problems (fast/slow/irregular heartbeat,||
1821|121|P|QT prolongation in the EKG).||
1821|122|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1821|123|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1821|124|P|machinery, or do anything that needs alertness until you can do||
1821|125|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1821|126|P|are using marijuana (cannabis).||
1821|127|P|   Before having surgery, tell your doctor or dentist about all||
1821|128|P|the products you use (including prescription drugs,||
1821|129|P|nonprescription drugs, and herbal products).||
1821|130|P|   During pregnancy, this medication should be used only when||
1821|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
1821|132|P|   It is unknown if this drug passes into breast milk. Consult||
1821|133|P|your doctor before breastfeeding.||
1821|134|B|||
1821|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1821|136|I|medications work or increase your risk for serious side effects.||
1821|137|I|This document does not contain all possible drug interactions.||
1821|138|I|Keep a list of all the products you use (including||
1821|139|I|prescription/nonprescription drugs and herbal products) and share||
1821|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
1821|141|I|the dosage of any medicines without your doctor's approval.||
1821|142|I|   A product that may interact with this drug is: valbenazine.||
1821|143|I|   Taking MAO inhibitors with this medication may cause a serious||
1821|144|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
1821|145|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1821|146|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1821|147|I|selegiline, tranylcypromine) during treatment with this||
1821|148|I|medication. Most MAO inhibitors should also not be taken for two||
1821|149|I|weeks before and after treatment with this medication. Ask your||
1821|150|I|doctor when to start or stop taking this medication.||
1821|151|I|   Deutetrabenazine is very similar to tetrabenazine. Do not use||
1821|152|I|medications containing tetrabenazine while using||
1821|153|I|deutetrabenazine.||
1821|154|B|||
1821|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1821|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1821|157|O|poison control center right away. US residents can call||
1821|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1821|159|O|Symptoms of overdose may include: muscle stiffness/pain, fixed||
1821|160|O|upward position of the eyeballs, sweating, dizziness, severe||
1821|161|O|drowsiness.||
1821|162|B|||
1821|163|N|NOTES:  Do not share this medication with others.||
1821|164|B|||
1821|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1821|166|D|remember. If it is near the time of the next dose, skip the||
1821|167|D|missed dose. Take your next dose at the regular time. Do not||
1821|168|D|double the dose to catch up.||
1821|169|B|||
1821|170|R|STORAGE:  Store at room temperature away from light and moisture.||
1821|171|R|Do not store in the bathroom. Keep the drying agent (desiccant)||
1821|172|R|in the bottle. Tightly close the bottle when not in use. Keep all||
1821|173|R|medications away from children and pets.||
1821|174|R|   Do not flush medications down the toilet or pour them into a||
1821|175|R|drain unless instructed to do so. Properly discard this product||
1821|176|R|when it is expired or no longer needed. Consult your pharmacist||
1821|177|R|or local waste disposal company.||
1821|178|B|||
1821|179|A|Information last revised September 2024.||
1821|180|A|Copyright(c) 2025 First Databank, Inc.||
1821|181|B|||
1822|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1822|002|Z|does NOT have all possible information about this product. This||
1822|003|Z|information does not assure that this product is safe, effective,||
1822|004|Z|or appropriate for you. This information is not individual||
1822|005|Z|medical advice and does not substitute for the advice of your||
1822|006|Z|health care professional. Always ask your health care||
1822|007|Z|professional for complete information about this product and your||
1822|008|Z|specific health needs.||
1822|009|B|||
1822|010|T|OCRELIZUMAB - INJECTION||
1822|011|F|(OK-re-LIZ-ue-mab)||
1822|012|B|||
1822|013|C|COMMON BRAND NAME(S): Ocrevus||
1822|014|B|||
1822|015|U|USES:  Ocrelizumab is used to treat certain forms of multiple||
1822|016|U|sclerosis-MS (relapsing or primary progressive forms). It is not||
1822|017|U|a cure for MS, but it is thought to help slow down nerve damage,||
1822|018|U|reduce the number of relapses, and delay disability. Ocrelizumab||
1822|019|U|belongs to a class of drugs known as monoclonal antibodies.||
1822|020|B|||
1822|021|H|HOW TO USE:  Read the Medication Guide provided by your||
1822|022|H|pharmacist before you start using ocrelizumab and each time you||
1822|023|H|get an infusion. If you have any questions, ask your doctor or||
1822|024|H|pharmacist.||
1822|025|H|   This medication is given by injection into a vein by a health||
1822|026|H|care professional. It is given as directed by your doctor on a||
1822|027|H|treatment schedule. The first 2 infusions are usually given 2||
1822|028|H|weeks apart. After that, an infusion is usually given once every||
1822|029|H|6 months. Follow your doctor's treatment schedule.||
1822|030|H|   Infusion reactions (rarely fatal) may happen during the||
1822|031|H|infusion of this drug and for up to 24 hours afterward. Your||
1822|032|H|doctor may prescribe other medications (including acetaminophen,||
1822|033|H|a corticosteroid such as methylprednisolone, an antihistamine||
1822|034|H|such as diphenhydramine) to help prevent these side effects. Tell||
1822|035|H|your doctor right away if you have any symptoms of infusion||
1822|036|H|reactions such as rash, itching, trouble breathing, throat||
1822|037|H|swelling/pain, tiredness, fever, fainting, flushing of the face,||
1822|038|H|nausea, headache, dizziness, or fast heartbeat. Your doctor may||
1822|039|H|slow down or stop your treatment for some time.||
1822|040|B|||
1822|041|S|SIDE EFFECTS:  See also How to Use section.||
1822|042|S|   Cold symptoms such as stuffy/runny nose or cough may occur. If||
1822|043|S|any of these effects last or get worse, tell your doctor or||
1822|044|S|pharmacist promptly.||
1822|045|S|   Remember that this medication has been prescribed because your||
1822|046|S|doctor has judged that the benefit to you is greater than the||
1822|047|S|risk of side effects. Many people using this medication do not||
1822|048|S|have serious side effects.||
1822|049|S|   Tell your doctor right away if you have any serious side||
1822|050|S|effects, including: diarrhea, stomach/abdominal pain,||
1822|051|S|bloody/black/tarry stools, signs of liver problems (such as||
1822|052|S|nausea/vomiting that doesn't stop, loss of appetite, yellowing||
1822|053|S|eyes/skin, dark urine).||
1822|054|S|   This medication may lower your ability to fight infections.||
1822|055|S|This may make you more likely to get a serious (rarely fatal)||
1822|056|S|infection or make any infection you have worse. Tell your doctor||
1822|057|S|right away if you have any signs of infection (such as sore||
1822|058|S|throat that doesn't go away, fever, chills, herpes cold sores or||
1822|059|S|genital sores, shingles).||
1822|060|S|   This medication may rarely increase your risk of developing||
1822|061|S|cancer, including breast cancer. Tell your doctor right away if||
1822|062|S|you have symptoms such as unusual growths, a lump in the breast,||
1822|063|S|nipple discharge. Ask your doctor for more details.||
1822|064|S|   This medication may increase your risk of getting a rare but||
1822|065|S|very serious (possibly fatal) brain infection (progressive||
1822|066|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1822|067|S|if you have any of these new or worsening side effects:||
1822|068|S|clumsiness, loss of coordination/balance, weakness, sudden change||
1822|069|S|in your thinking (such as confusion, difficulty concentrating,||
1822|070|S|memory loss), difficulty talking/walking, seizure, vision||
1822|071|S|changes.||
1822|072|S|   A very serious allergic reaction to this drug is rare.||
1822|073|S|However, get medical help right away if you notice any symptoms||
1822|074|S|of a serious allergic reaction, including: rash, itching/swelling||
1822|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1822|076|S|breathing.||
1822|077|S|   This is not a complete list of possible side effects. If you||
1822|078|S|notice other effects not listed above, contact your doctor or||
1822|079|S|pharmacist.||
1822|080|S|   In the US -||
1822|081|S|   Call your doctor for medical advice about side effects. You||
1822|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1822|083|S|www.fda.gov/medwatch.||
1822|084|S|   In Canada - Call your doctor for medical advice about side||
1822|085|S|effects. You may report side effects to Health Canada at||
1822|086|S|1-866-234-2345.||
1822|087|B|||
1822|088|P|PRECAUTIONS:  Before using ocrelizumab, tell your doctor or||
1822|089|P|pharmacist if you are allergic to it; or if you have any other||
1822|090|P|allergies. This product may contain inactive ingredients, which||
1822|091|P|can cause allergic reactions or other problems. Talk to your||
1822|092|P|pharmacist for more details.||
1822|093|P|   Before using this medication, tell your doctor or pharmacist||
1822|094|P|your medical history, especially of: current/past/returning||
1822|095|P|infections (such as herpes, tuberculosis), liver problems (such||
1822|096|P|as hepatitis B).||
1822|097|P|   Ocrelizumab can make you more likely to get infections or may||
1822|098|P|make current infections worse. Stay away from anyone who has an||
1822|099|P|infection that may easily spread (such as chickenpox, COVID-19,||
1822|100|P|measles, flu). Talk to your doctor if you have been exposed to an||
1822|101|P|infection or for more details.||
1822|102|P|   Tell your health care professional that you are using||
1822|103|P|ocrelizumab before having any immunizations/vaccinations. Avoid||
1822|104|P|contact with people who have recently received live vaccines||
1822|105|P|(such as flu vaccine inhaled through the nose).||
1822|106|P|   Before having surgery, tell your doctor or dentist about all||
1822|107|P|the products you use (including prescription drugs,||
1822|108|P|nonprescription drugs, and herbal products).||
1822|109|P|   Tell your doctor if you are pregnant or plan to become||
1822|110|P|pregnant. You should not become pregnant while using ocrelizumab.||
1822|111|P|Ocrelizumab may harm an unborn baby. Ask about reliable forms of||
1822|112|P|birth control while using this medication and for 6 months after||
1822|113|P|the last dose. If you become pregnant, talk to your doctor right||
1822|114|P|away about the risks and benefits of this medication.||
1822|115|P|   It is unknown if this medication passes into breast milk.||
1822|116|P|Consult your doctor before breastfeeding.||
1822|117|B|||
1822|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1822|119|I|medications work or increase your risk for serious side effects.||
1822|120|I|This document does not contain all possible drug interactions.||
1822|121|I|Keep a list of all the products you use (including||
1822|122|I|prescription/nonprescription drugs and herbal products) and share||
1822|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
1822|124|I|the dosage of any medicines without your doctor's approval.||
1822|125|I|   Some products that may interact with this drug are: other||
1822|126|I|drugs that weaken the immune system/increase the risk of||
1822|127|I|infection (such as natalizumab, rituximab).||
1822|128|B|||
1822|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1822|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1822|131|O|poison control center right away. US residents can call||
1822|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1822|133|B|||
1822|134|N|NOTES:  Lab and/or medical tests (such as tests for hepatitis B,||
1822|135|N|liver function, breast cancer screening, immunoglobulin levels)||
1822|136|N|should be done before you start using this medication and while||
1822|137|N|you are using it. Keep all medical and lab appointments. Consult||
1822|138|N|your doctor for more details.||
1822|139|B|||
1822|140|D|MISSED DOSE:  It is important to get each dose of this medication||
1822|141|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1822|142|D|right away for a new dosing schedule.||
1822|143|B|||
1822|144|R|STORAGE:  Not applicable. This medication is given in a hospital||
1822|145|R|or clinic and will not be stored at home.||
1822|146|B|||
1822|147|M|MEDICAL ALERT:  Your condition can cause complications in a||
1822|148|M|medical emergency. For information about enrolling in MedicAlert,||
1822|149|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1822|150|B|||
1822|151|A|Information last revised August 2025.||
1822|152|A|Copyright(c) 2025 First Databank, Inc.||
1822|153|B|||
1823|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1823|002|Z|does NOT have all possible information about this product. This||
1823|003|Z|information does not assure that this product is safe, effective,||
1823|004|Z|or appropriate for you. This information is not individual||
1823|005|Z|medical advice and does not substitute for the advice of your||
1823|006|Z|health care professional. Always ask your health care||
1823|007|Z|professional for complete information about this product and your||
1823|008|Z|specific health needs.||
1823|009|B|||
1823|010|T|DUPILUMAB - INJECTION||
1823|011|F|(doo-PIL-ue-mab)||
1823|012|B|||
1823|013|C|COMMON BRAND NAME(S): Dupixent||
1823|014|B|||
1823|015|U|USES:  This medication is used to treat certain skin conditions||
1823|016|U|(eczema, prurigo nodularis, bullous pemphigoid) and a certain||
1823|017|U|esophagus problem (eosinophilic esophagitis). It is also used||
1823|018|U|along with other medications to help control and prevent symptoms||
1823|019|U|(such as wheezing and shortness of breath) caused by asthma or||
1823|020|U|ongoing lung disease (chronic obstructive pulmonary||
1823|021|U|disease-COPD). In addition, dupilumab may be used to reduce||
1823|022|U|symptoms caused by nasal polyps and the long-term swelling of the||
1823|023|U|sinuses and nasal passage (chronic rhinosinusitis with nasal||
1823|024|U|polyposis). It is also used to treat hives from an unknown cause||
1823|025|U|(chronic spontaneous urticaria- CSU). Dupilumab belongs to a||
1823|026|U|class of drugs known as monoclonal antibodies. It works by||
1823|027|U|blocking certain natural proteins in your body (interleukin-4 and||
1823|028|U|interleukin-13) that may cause inflammation and swelling.||
1823|029|U|   This medication should not be used to relieve sudden shortness||
1823|030|U|of breath or wheezing. If sudden breathing problems occur, use||
1823|031|U|your quick-relief inhaler (such as albuterol, also called||
1823|032|U|salbutamol in some countries) as prescribed.||
1823|033|B|||
1823|034|H|HOW TO USE:  Read the Patient Information Leaflet and||
1823|035|H|Instructions for Use provided by your pharmacist before you start||
1823|036|H|using dupilumab and each time you get a refill. Ask your health||
1823|037|H|care professional how to prepare and use this medication. If you||
1823|038|H|have any questions, ask your doctor or pharmacist.||
1823|039|H|   Inject this medication under the skin as directed by your||
1823|040|H|doctor. The injection is given in the upper arms, thighs, or||
1823|041|H|abdomen (except for a 2-inch area around your belly button). The||
1823|042|H|dosage is based on your medical condition and response to||
1823|043|H|treatment. Children's dosage may also be based on weight.||
1823|044|H|   Depending on your product, take the medication out of the||
1823|045|H|refrigerator 30 or 45 minutes before you inject it to allow it to||
1823|046|H|reach room temperature. Do not warm up this medication any other||
1823|047|H|way (for example, do not heat it in the microwave, place it in||
1823|048|H|hot water, or leave it in direct sunlight). Do not shake the||
1823|049|H|medication. Before using, check this product for cloudiness,||
1823|050|H|particles, or discoloration. If you see any of these things, do||
1823|051|H|not use the liquid. Before injecting each dose, clean the skin||
1823|052|H|you are going to inject into (the injection site) with rubbing||
1823|053|H|alcohol. Change the injection site each time to lessen injury||
1823|054|H|under the skin. Do not inject into skin that is tender, damaged,||
1823|055|H|bruised or scarred. To lessen bruising, do not rub the injection||
1823|056|H|site after a shot. Learn how to store and discard medical||
1823|057|H|supplies safely.||
1823|058|H|   Use this medication regularly to get the most benefit from it.||
1823|059|H|To help you remember, mark your calendar with a reminder.||
1823|060|H|   Tell your doctor if your condition does not get better or if||
1823|061|H|it gets worse.||
1823|062|B|||
1823|063|S|SIDE EFFECTS:  Redness, irritation, or pain at the injection site||
1823|064|S|may occur. Swelling/redness/itching of the eyes or eyelids may||
1823|065|S|also occur. If any of these effects last or get worse, tell your||
1823|066|S|doctor or pharmacist promptly.||
1823|067|S|   Remember that this medication has been prescribed because your||
1823|068|S|doctor has judged that the benefit to you is greater than the||
1823|069|S|risk of side effects. Many people using this medication do not||
1823|070|S|have serious side effects.||
1823|071|S|   Tell your doctor right away if you have any serious side||
1823|072|S|effects, including: other eye problems (such as eye pain, changes||
1823|073|S|in vision), joint pain, new or worsening skin problems (such as||
1823|074|S|psoriasis).||
1823|075|S|   Rarely, people with asthma who also use a steroid medication||
1823|076|S|have had symptoms that might be due to stopping or lowering the||
1823|077|S|dose of their steroid. Tell your doctor right away if you develop||
1823|078|S|symptoms such as fever that doesn't go away, brown/dark urine,||
1823|079|S|chest pain, or numbness/tingling in your arms or legs. Do not||
1823|080|S|stop or change the dose of your steroid medication without your||
1823|081|S|doctor's direction.||
1823|082|S|   A very serious allergic reaction to this drug is rare.||
1823|083|S|However, get medical help right away if you notice any symptoms||
1823|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1823|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1823|086|S|breathing.||
1823|087|S|   This is not a complete list of possible side effects. If you||
1823|088|S|notice other effects not listed above, contact your doctor or||
1823|089|S|pharmacist.||
1823|090|S|   In the US -||
1823|091|S|   Call your doctor for medical advice about side effects. You||
1823|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1823|093|S|www.fda.gov/medwatch.||
1823|094|S|   In Canada - Call your doctor for medical advice about side||
1823|095|S|effects. You may report side effects to Health Canada at||
1823|096|S|1-866-234-2345.||
1823|097|B|||
1823|098|P|PRECAUTIONS:  Before using dupilumab, tell your doctor or||
1823|099|P|pharmacist if you are allergic to it; or if you have any other||
1823|100|P|allergies. This product may contain inactive ingredients, which||
1823|101|P|can cause allergic reactions or other problems. Talk to your||
1823|102|P|pharmacist for more details.||
1823|103|P|   Before using this medication, tell your doctor or pharmacist||
1823|104|P|your medical history, especially of: a certain type of infection||
1823|105|P|(helminth).||
1823|106|P|   Tell your health care professional that you are using||
1823|107|P|dupilumab before having any immunizations/vaccinations. Avoid||
1823|108|P|contact with people who have recently received live vaccines||
1823|109|P|(such as flu vaccine inhaled through the nose).||
1823|110|P|   Before having surgery, tell your doctor or dentist about all||
1823|111|P|the products you use (including prescription drugs,||
1823|112|P|nonprescription drugs, and herbal products).||
1823|113|P|   During pregnancy, this medication should be used only when||
1823|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
1823|115|P|   It is unknown if this medication passes into breast milk.||
1823|116|P|Consult your doctor before breastfeeding.||
1823|117|B|||
1823|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1823|119|I|medications work or increase your risk for serious side effects.||
1823|120|I|This document does not contain all possible drug interactions.||
1823|121|I|Keep a list of all the products you use (including||
1823|122|I|prescription/nonprescription drugs and herbal products) and share||
1823|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
1823|124|I|the dosage of any medicines without your doctor's approval.||
1823|125|B|||
1823|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1823|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1823|128|O|poison control center right away. US residents can call||
1823|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1823|130|B|||
1823|131|N|NOTES:  Do not share this medication with others.||
1823|132|B|||
1823|133|D|MISSED DOSE:  It is important to get each dose of this medication||
1823|134|D|as scheduled. If your dose is given weekly and you miss a dose,||
1823|135|D|use it as soon as you remember. Start your new weekly dosing||
1823|136|D|schedule from that day on. If your dose is given every 2 or 4||
1823|137|D|weeks and you miss a dose, give a dose if it is less than 7 days||
1823|138|D|from the missed dose. Use your next dose at the regular time. If||
1823|139|D|your dose is given every 2 or 4 weeks and it is more than 7 days||
1823|140|D|from the missed dose, start a new dosing schedule with the first||
1823|141|D|dose given right away. For any missed doses, do not double the||
1823|142|D|dose to catch up.||
1823|143|B|||
1823|144|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1823|145|R|medication in the original carton to protect from light. This||
1823|146|R|medication may also be stored at room temperature if needed. If||
1823|147|R|the medication is stored at room temperature, discard after 14||
1823|148|R|days. Keep all medications away from children and pets.||
1823|149|R|   Do not flush medications down the toilet or pour them into a||
1823|150|R|drain unless instructed to do so. Properly discard this product||
1823|151|R|when it is expired or no longer needed. Consult your pharmacist||
1823|152|R|or local waste disposal company.||
1823|153|B|||
1823|154|M|MEDICAL ALERT:  Your condition can cause complications in a||
1823|155|M|medical emergency. For information about enrolling in MedicAlert,||
1823|156|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1823|157|B|||
1823|158|A|Information last revised June 2025.||
1823|159|A|Copyright(c) 2025 First Databank, Inc.||
1823|160|B|||
1824|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1824|002|Z|does NOT have all possible information about this product. This||
1824|003|Z|information does not assure that this product is safe, effective,||
1824|004|Z|or appropriate for you. This information is not individual||
1824|005|Z|medical advice and does not substitute for the advice of your||
1824|006|Z|health care professional. Always ask your health care||
1824|007|Z|professional for complete information about this product and your||
1824|008|Z|specific health needs.||
1824|009|B|||
1824|010|T|TETRACAINE/OXYMETAZOLINE SPRAY - NASAL||
1824|011|F|(TET-ra-kane/OX-i-me-TAZ-oh-leen)||
1824|012|B|||
1824|013|C|COMMON BRAND NAME(S): Kovanaze||
1824|014|B|||
1824|015|U|USES:  This medication is a nasal spray used to cause numbness in||
1824|016|U|your mouth before dental procedures on certain teeth. It contains||
1824|017|U|2 ingredients: tetracaine and oxymetazoline. Tetracaine is a||
1824|018|U|local anesthetic that works by blocking nerves, which causes||
1824|019|U|temporary numbness of the area. Oxymetazoline works by narrowing||
1824|020|U|blood vessels in the nose area, which helps the tetracaine work||
1824|021|U|better.||
1824|022|B|||
1824|023|H|HOW TO USE:  This medication is given as directed by your dental||
1824|024|H|professional, usually 2 sprays into the nose on the same side as||
1824|025|H|the tooth on which the dental procedure will be done. The 2||
1824|026|H|sprays are usually given 4 to 5 minutes apart. Your dentist may||
1824|027|H|test drill the tooth to check if you are numb. One more spray may||
1824|028|H|be given if the area is not numb 10 minutes after the second||
1824|029|H|spray.||
1824|030|B|||
1824|031|S|SIDE EFFECTS:  Runny/stuffy nose, nasal discomfort/pain, mild||
1824|032|S|nose bleed, watery eye(s), numb/sore throat, headache, dizziness,||
1824|033|S|or change in sense of taste may occur. If any of these effects||
1824|034|S|last or get worse, tell your doctor or pharmacist promptly.||
1824|035|S|   Remember that this medication has been prescribed because your||
1824|036|S|dentist has judged that the benefit to you is greater than the||
1824|037|S|risk of side effects. Many people using this medication do not||
1824|038|S|have serious side effects.||
1824|039|S|   Tell your doctor or dentist right away if you have any serious||
1824|040|S|side effects, including: trouble swallowing, nasal ulcers.||
1824|041|S|   Get medical help right away if you have any very serious side||
1824|042|S|effects, including: pale/bluish/gray skin, unusual tiredness,||
1824|043|S|shortness of breath, fast heartbeat.||
1824|044|S|   A very serious allergic reaction to this drug is rare.||
1824|045|S|However, get medical help right away if you notice any symptoms||
1824|046|S|of a serious allergic reaction, including: rash, itching/swelling||
1824|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1824|048|S|breathing.||
1824|049|S|   This is not a complete list of possible side effects. If you||
1824|050|S|notice other effects not listed above, contact your doctor or||
1824|051|S|pharmacist.||
1824|052|S|   In the US -||
1824|053|S|   Call your doctor for medical advice about side effects. You||
1824|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1824|055|S|www.fda.gov/medwatch.||
1824|056|S|   In Canada - Call your doctor for medical advice about side||
1824|057|S|effects. You may report side effects to Health Canada at||
1824|058|S|1-866-234-2345.||
1824|059|B|||
1824|060|P|PRECAUTIONS:  Before using this product, tell your doctor,||
1824|061|P|dentist, or pharmacist if you are allergic to tetracaine or||
1824|062|P|oxymetazoline; or to other "caine" anesthetics (such as||
1824|063|P|benzocaine); or if you have any other allergies. This product may||
1824|064|P|contain inactive ingredients, which can cause allergic reactions||
1824|065|P|or other problems. Talk to your pharmacist for more details.||
1824|066|P|   Before using this medication, tell your doctor or pharmacist||
1824|067|P|your medical history, especially of: high blood pressure, thyroid||
1824|068|P|disease, frequent nose bleeds (5 or more each month), a certain||
1824|069|P|blood disorder (methemoglobinemia).||
1824|070|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1824|071|P|can make you more dizzy. Do not drive, use machinery, or do||
1824|072|P|anything that needs alertness until you can do it safely. Limit||
1824|073|P|alcoholic beverages. Talk to your doctor if you are using||
1824|074|P|marijuana (cannabis).||
1824|075|P|   Before having surgery, tell your doctor or dentist about all||
1824|076|P|the products you use (including prescription drugs,||
1824|077|P|nonprescription drugs, and herbal products).||
1824|078|P|   During pregnancy, this medication should be used only when||
1824|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
1824|080|P|   It is unknown if this product passes into breast milk. Consult||
1824|081|P|your doctor before breastfeeding.||
1824|082|B|||
1824|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1824|084|I|medications work or increase your risk for serious side effects.||
1824|085|I|This document does not contain all possible drug interactions.||
1824|086|I|Keep a list of all the products you use (including||
1824|087|I|prescription/nonprescription drugs and herbal products) and share||
1824|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
1824|089|I|the dosage of any medicines without your doctor's approval.||
1824|090|I|   Some products that may interact with this drug are: other||
1824|091|I|nasal products.||
1824|092|I|   Do not use other products that also contain oxymetazoline for||
1824|093|I|24 hours before using this medication.||
1824|094|B|||
1824|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1824|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1824|097|O|poison control center right away. US residents can call||
1824|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1824|099|B|||
1824|100|N|NOTES:  Do not share this medication with others.||
1824|101|B|||
1824|102|D|MISSED DOSE:  Not applicable.||
1824|103|B|||
1824|104|R|STORAGE:  Not applicable. This medication is given in a dental||
1824|105|R|office and will not be stored at home.||
1824|106|B|||
1824|107|A|Information last revised January 2025.||
1824|108|A|Copyright(c) 2025 First Databank, Inc.||
1824|109|B|||
1825|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1825|002|Z|does NOT have all possible information about this product. This||
1825|003|Z|information does not assure that this product is safe, effective,||
1825|004|Z|or appropriate for you. This information is not individual||
1825|005|Z|medical advice and does not substitute for the advice of your||
1825|006|Z|health care professional. Always ask your health care||
1825|007|Z|professional for complete information about this product and your||
1825|008|Z|specific health needs.||
1825|009|B|||
1825|010|T|FLUTICASONE/SALMETEROL POWDER INHALER - ORAL INHALATION||
1825|011|F|(floo-TIK-a-sone/sal-MEE-ter-ol)||
1825|012|B|||
1825|013|C|COMMON BRAND NAME(S): Airduo Respiclick, AirDuo Digihaler||
1825|014|B|||
1825|015|U|USES:  This product is used to control and prevent symptoms||
1825|016|U|(wheezing and shortness of breath) caused by asthma. It contains||
1825|017|U|2 medications: fluticasone and salmeterol. Fluticasone belongs to||
1825|018|U|a class of drugs known as corticosteroids. It works by reducing||
1825|019|U|the irritation and swelling of the airways. Salmeterol belongs to||
1825|020|U|a class of drugs known as long-acting beta agonists. It works by||
1825|021|U|relaxing the muscles around the airways so that they open up and||
1825|022|U|you can breathe more easily. Controlling symptoms of breathing||
1825|023|U|problems can decrease time lost from work or school.||
1825|024|U|   When used alone, long-acting beta agonists (such as||
1825|025|U|salmeterol) may rarely increase the risk of serious (sometimes||
1825|026|U|fatal) asthma-related breathing problems. However, combination||
1825|027|U|inhaled corticosteroid and long-acting beta agonists, such as||
1825|028|U|this product, do not increase the risk of serious asthma-related||
1825|029|U|breathing problems. This product should be used when breathing||
1825|030|U|problems are not well controlled with one asthma-control||
1825|031|U|medication (such as inhaled corticosteroid) or if your symptoms||
1825|032|U|need combination treatment.||
1825|033|U|   Before using this medication, it is important to learn how to||
1825|034|U|use it properly. This medication must be used regularly to be||
1825|035|U|effective. It does not work right away and should not be used to||
1825|036|U|relieve sudden asthma attacks. If an asthma attack occurs, use||
1825|037|U|your quick-relief inhaler (such as albuterol, also called||
1825|038|U|salbutamol in some countries) as prescribed.||
1825|039|B|||
1825|040|V|OTHER USES:  This section contains uses of this drug that are not||
1825|041|V|listed in the approved professional labeling for the drug but||
1825|042|V|that may be prescribed by your health care professional. Use this||
1825|043|V|drug for a condition that is listed in this section only if it||
1825|044|V|has been so prescribed by your health care professional.||
1825|045|V|   This drug may also be used to control symptoms (such as||
1825|046|V|wheezing and shortness of breath) caused by ongoing lung disease||
1825|047|V|(chronic obstructive pulmonary disease-COPD, which includes||
1825|048|V|chronic bronchitis and emphysema).||
1825|049|B|||
1825|050|H|HOW TO USE:  Read the Patient Information Leaflet and||
1825|051|H|Instructions for Use provided by your pharmacist before you start||
1825|052|H|using this medication and each time you get a refill. Follow the||
1825|053|H|illustrated directions for the proper use of this medication. If||
1825|054|H|you have any questions, ask your doctor or pharmacist.||
1825|055|H|   Make sure the cap is closed before you start using your||
1825|056|H|inhaler. Hold the inhaler upright and open the cap until it||
1825|057|H|"clicks." Inhale this medication by mouth as directed by your||
1825|058|H|doctor, usually twice daily (in the morning and evening, 12 hours||
1825|059|H|apart). You may or may not taste/feel the drug when you inhale.||
1825|060|H|Either is normal. Do not exhale into the device. Close the cap||
1825|061|H|firmly after each use.||
1825|062|H|   Do not take the inhaler apart or wash the mouthpiece or any||
1825|063|H|part of the device. Do not open the cap unless you are ready for||
1825|064|H|your next dose.||
1825|065|H|   If you are using other inhalers at the same time, wait at||
1825|066|H|least 1 minute between the use of each medication, and use this||
1825|067|H|drug last.||
1825|068|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
1825|069|H|from developing, gargle, rinse your mouth with water and spit out||
1825|070|H|after each use. Do not swallow the rinse water.||
1825|071|H|   The dosage is based on your medical condition and response to||
1825|072|H|treatment.||
1825|073|H|   Use this medication regularly to get the most benefit from it.||
1825|074|H|This medication works best if used at evenly spaced times. To||
1825|075|H|help you remember, use it at the same times each day. Do not||
1825|076|H|increase your dose, use this product more often, or stop using it||
1825|077|H|without talking with your doctor. Also, do not use other||
1825|078|H|long-acting beta agonists while using this medication.||
1825|079|H|   If you have been using a quick-relief inhaler (such as||
1825|080|H|albuterol, also called salbutamol in some countries) on a regular||
1825|081|H|daily schedule (such as 4 times daily), you must stop this||
1825|082|H|schedule and only use the quick-relief inhaler as needed for||
1825|083|H|sudden shortness of breath/asthma attacks. Consult your doctor||
1825|084|H|for details.||
1825|085|H|   If you are regularly taking a different corticosteroid by||
1825|086|H|mouth (such as prednisone), you should not stop taking it unless||
1825|087|H|directed by your doctor. Some conditions (such as asthma,||
1825|088|H|allergies) may become worse when the drug is suddenly stopped. If||
1825|089|H|you suddenly stop taking the drug, you may also have withdrawal||
1825|090|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
1825|091|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
1825|092|H|doctor may slowly lower the dose of your old medication after you||
1825|093|H|begin using fluticasone/salmeterol. Tell your doctor or||
1825|094|H|pharmacist right away if you have withdrawal. See also||
1825|095|H|Precautions section.||
1825|096|H|   It may take 1 week or longer before you get the full benefit||
1825|097|H|of this drug.||
1825|098|H|   Learn which of your inhalers you should use every day||
1825|099|H|(controller drugs) and which you should use if your breathing||
1825|100|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
1825|101|H|time what you should do if you have new or worsening cough or||
1825|102|H|shortness of breath, wheezing, increased sputum, worsening peak||
1825|103|H|flow meter readings, waking up at night with trouble breathing,||
1825|104|H|if you use your quick-relief inhaler more often (more than 2 days||
1825|105|H|a week), or if your quick-relief inhaler does not seem to be||
1825|106|H|working well. Learn when you can treat sudden breathing problems||
1825|107|H|by yourself and when you must get medical help right away.||
1825|108|H|   Tell your doctor if you do not get better or if you get worse.||
1825|109|B|||
1825|110|S|SIDE EFFECTS:  See also Precautions section.||
1825|111|S|   Hoarseness, dry/irritated throat, or headache may occur. If||
1825|112|S|any of these effects last or get worse, tell your doctor or||
1825|113|S|pharmacist promptly.||
1825|114|S|   Remember that this medication has been prescribed because your||
1825|115|S|doctor has judged that the benefit to you is greater than the||
1825|116|S|risk of side effects. Many people using this medication do not||
1825|117|S|have serious side effects.||
1825|118|S|   This medication may raise your blood pressure. Check your||
1825|119|S|blood pressure regularly and tell your doctor if the results are||
1825|120|S|high.||
1825|121|S|   Rarely, this medication may cause sudden breathing||
1825|122|S|problems/asthma right after you use it. If this occurs, use your||
1825|123|S|quick-relief inhaler and get medical help right away.||
1825|124|S|   Tell your doctor right away if you have any serious side||
1825|125|S|effects, including: white patches on tongue/in mouth, signs of||
1825|126|S|infection (such as sore throat that doesn't go away, fever,||
1825|127|S|chills), mental/mood changes (such as nervousness), trouble||
1825|128|S|sleeping, vision problems (such as blurred vision), increased||
1825|129|S|thirst/urination, muscle cramps, shaking (tremors).||
1825|130|S|   Get medical help right away if you have any very serious side||
1825|131|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1825|132|S|dizziness, fainting, seizures.||
1825|133|S|   A very serious allergic reaction to this product is rare.||
1825|134|S|However, get medical help right away if you notice any symptoms||
1825|135|S|of a serious allergic reaction, including: rash, itching/swelling||
1825|136|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1825|137|S|breathing.||
1825|138|S|   This is not a complete list of possible side effects. If you||
1825|139|S|notice other effects not listed above, contact your doctor or||
1825|140|S|pharmacist.||
1825|141|S|   In the US -||
1825|142|S|   Call your doctor for medical advice about side effects. You||
1825|143|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1825|144|S|www.fda.gov/medwatch.||
1825|145|S|   In Canada - Call your doctor for medical advice about side||
1825|146|S|effects. You may report side effects to Health Canada at||
1825|147|S|1-866-234-2345.||
1825|148|B|||
1825|149|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1825|150|P|pharmacist if you are allergic to fluticasone or salmeterol; or||
1825|151|P|if you have any other allergies. This product may contain||
1825|152|P|inactive ingredients (such as lactose, milk proteins), which can||
1825|153|P|cause allergic reactions or other problems. Talk to your||
1825|154|P|pharmacist for more details.||
1825|155|P|   Before using this medication, tell your doctor or pharmacist||
1825|156|P|your medical history, especially of: current/past infections||
1825|157|P|(such as tuberculosis, herpes), high blood pressure, bone loss||
1825|158|P|(osteoporosis), heart disease (such as chest pain, heart attack,||
1825|159|P|irregular heartbeat), overactive thyroid (hyperthyroidism),||
1825|160|P|diabetes, eye problems (such as cataracts, glaucoma), seizures,||
1825|161|P|liver disease.||
1825|162|P|   Salmeterol may cause a condition that affects the heart rhythm||
1825|163|P|(QT prolongation). QT prolongation can rarely cause serious||
1825|164|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1825|165|P|as severe dizziness, fainting) that need medical attention right||
1825|166|P|away.||
1825|167|P|   The risk of QT prolongation may be increased if you have||
1825|168|P|certain medical conditions or are taking other drugs that may||
1825|169|P|cause QT prolongation. Before using this product, tell your||
1825|170|P|doctor or pharmacist of all the drugs you take and if you have||
1825|171|P|any of the following conditions: certain heart problems (heart||
1825|172|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1825|173|P|history of certain heart problems (QT prolongation in the EKG,||
1825|174|P|sudden cardiac death).||
1825|175|P|   Low levels of potassium or magnesium in the blood may also||
1825|176|P|increase your risk of QT prolongation. This risk may increase if||
1825|177|P|you use certain drugs (such as diuretics/"water pills") or if you||
1825|178|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1825|179|P|Talk to your doctor about using this medication safely.||
1825|180|P|   This medication may mask signs of infection. It can make you||
1825|181|P|more likely to get infections or may make current infections||
1825|182|P|worse. Stay away from anyone who has an infection that may easily||
1825|183|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1825|184|P|doctor if you have been exposed to an infection or for more||
1825|185|P|details.||
1825|186|P|   If you have switched from a corticosteroid taken by mouth||
1825|187|P|(such as prednisone tablets) to this inhaler within the past 12||
1825|188|P|months, or if you have been using this product in||
1825|189|P|higher-than-usual doses for a long time, it may be more difficult||
1825|190|P|for your body to respond to physical stress. Before having||
1825|191|P|surgery or emergency treatment, or if you get a serious||
1825|192|P|illness/injury, tell your doctor or dentist that you are using||
1825|193|P|this medication or have used a corticosteroid taken by mouth||
1825|194|P|within the past 12 months. Tell your doctor right away if you||
1825|195|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
1825|196|P|card or medical ID bracelet that says you use (or have used)||
1825|197|P|corticosteroid medications.||
1825|198|P|   Before having surgery, tell your doctor or dentist about all||
1825|199|P|the products you use (including prescription drugs,||
1825|200|P|nonprescription drugs, and herbal products).||
1825|201|P|   Older adults with COPD may be at greater risk for pneumonia||
1825|202|P|while using this drug. Older adults may also be more sensitive to||
1825|203|P|the side effects of this drug, especially QT prolongation (see||
1825|204|P|above).||
1825|205|P|   This medication may temporarily slow down a child's growth if||
1825|206|P|used for a long time. However, poorly controlled asthma can also||
1825|207|P|slow down growth. See the doctor regularly so your child's height||
1825|208|P|can be checked.||
1825|209|P|   During pregnancy, this medication should be used only when||
1825|210|P|clearly needed. Discuss the risks and benefits with your doctor.||
1825|211|P|   It is unknown if this medication passes into breast milk.||
1825|212|P|Consult your doctor before breastfeeding.||
1825|213|B|||
1825|214|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1825|215|I|medications work or increase your risk for serious side effects.||
1825|216|I|This document does not contain all possible drug interactions.||
1825|217|I|Keep a list of all the products you use (including||
1825|218|I|prescription/nonprescription drugs and herbal products) and share||
1825|219|I|it with your doctor and pharmacist. Do not start, stop, or change||
1825|220|I|the dosage of any medicines without your doctor's approval.||
1825|221|I|   Some products that may interact with this drug include:||
1825|222|I|aldesleukin, desmopressin.||
1825|223|I|   Other medications can affect the removal of fluticasone and||
1825|224|I|salmeterol from your body, which may affect how this product||
1825|225|I|works. Examples include azole antifungals (such as ketoconazole),||
1825|226|I|cobicistat, macrolide antibiotics (such as clarithromycin), HIV||
1825|227|I|protease inhibitors (such as lopinavir), nefazodone, ritonavir,||
1825|228|I|telithromycin, among others.||
1825|229|B|||
1825|230|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1825|231|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1825|232|O|poison control center right away. US residents can call||
1825|233|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1825|234|O|Symptoms of overdose may include: shaking (tremors), chest pain,||
1825|235|O|fast/irregular heartbeat, seizures.||
1825|236|B|||
1825|237|N|NOTES:  Do not share this medication with others.||
1825|238|N|   Lab and/or medical tests (such as lung function, blood||
1825|239|N|pressure, bone density tests, eye exams) may be done while you||
1825|240|N|are using this medication. Keep all medical and lab appointments.||
1825|241|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
1825|242|N|mold that can worsen breathing problems. Because the flu virus||
1825|243|N|can also worsen breathing problems, ask your doctor or pharmacist||
1825|244|N|if you should have a flu shot every year.||
1825|245|N|   This medication may cause bone loss (osteoporosis) in adults||
1825|246|N|when used for a long time. Lifestyle changes that may help reduce||
1825|247|N|the risk of bone problems include doing weight-bearing exercise,||
1825|248|N|stopping smoking, limiting alcohol, and getting enough calcium||
1825|249|N|and vitamin D. Talk to your doctor for more details.||
1825|250|B|||
1825|251|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1825|252|D|next dose at the regular time. Do not double the dose to catch||
1825|253|D|up.||
1825|254|B|||
1825|255|R|STORAGE:  Store at room temperature away from moisture and heat.||
1825|256|R|Do not store in the bathroom. Do not open the original foil||
1825|257|R|package until you are ready to use the medication. Once the foil||
1825|258|R|package is opened, this medication expires after 1 month. Keep||
1825|259|R|all medications away from children and pets.||
1825|260|R|   Do not flush medications down the toilet or pour them into a||
1825|261|R|drain unless instructed to do so. Properly discard this product||
1825|262|R|when it is expired or no longer needed. Consult your pharmacist||
1825|263|R|or local waste disposal company.||
1825|264|B|||
1825|265|M|MEDICAL ALERT:  Your condition can cause complications in a||
1825|266|M|medical emergency. For information about enrolling in MedicAlert,||
1825|267|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1825|268|B|||
1825|269|A|Information last revised September 2025.||
1825|270|A|Copyright(c) 2025 First Databank, Inc.||
1825|271|B|||
1826|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1826|002|Z|does NOT have all possible information about this product. This||
1826|003|Z|information does not assure that this product is safe, effective,||
1826|004|Z|or appropriate for you. This information is not individual||
1826|005|Z|medical advice and does not substitute for the advice of your||
1826|006|Z|health care professional. Always ask your health care||
1826|007|Z|professional for complete information about this product and your||
1826|008|Z|specific health needs.||
1826|009|B|||
1826|010|T|PEGCETACOPLAN - SUBCUTANEOUS INJECTION||
1826|011|F|(peg-SET-a-KOE-plan)||
1826|012|B|||
1826|013|C|COMMON BRAND NAME(S): Empaveli||
1826|014|B|||
1826|015|W|WARNING:  Pegcetacoplan can lower your body's ability to fight||
1826|016|W|infections. This increases your chance of getting very serious||
1826|017|W|(possibly fatal) infections (especially meningitis or sepsis).||
1826|018|W|Get medical help right away if you develop symptoms such as||
1826|019|W|nausea/vomiting that doesn't stop, fever, chills, severe||
1826|020|W|headache, stiff neck, mental/mood changes (such as confusion),||
1826|021|W|muscle aches with flu-like symptoms, eye sensitivity to light.||
1826|022|W|   Your doctor may prescribe certain vaccines for you to get at||
1826|023|W|least 2 weeks before receiving this medication. Vaccines may not||
1826|024|W|fully protect everyone who receives them, so you should still||
1826|025|W|watch for signs of infection after you get the vaccine.||
1826|026|W|   To receive pegcetacoplan in the United States, you must||
1826|027|W|understand, agree to, and carefully follow the requirements of||
1826|028|W|the REMS Program for this medication. If you live in Canada or||
1826|029|W|any other country, consult your doctor and pharmacist for your||
1826|030|W|country's regulations.||
1826|031|B|||
1826|032|U|USES:  Pegcetacoplan is used to treat a certain blood disorder||
1826|033|U|(paroxysmal nocturnal hemoglobinuria). This disorder causes your||
1826|034|U|body's immune system to destroy red blood cells, which results in||
1826|035|U|anemia. It works by helping block your body's destruction of red||
1826|036|U|blood cells. This effect helps lessen symptoms of anemia (such as||
1826|037|U|tiredness, shortness of breath), and may reduce the need for||
1826|038|U|blood transfusions.||
1826|039|U|   This medication is also used to treat certain kidney problems||
1826|040|U|(such as complement 3 glomerulopathy - C3G, primary||
1826|041|U|immune-complex membranoproliferative glomerulonephritis -||
1826|042|U|IC-MPGN). Pegcetacoplan helps to lower levels of protein in the||
1826|043|U|urine.||
1826|044|B|||
1826|045|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1826|046|H|provided by your pharmacist before you start using pegcetacoplan||
1826|047|H|and each time you get a refill. Carry the Patient Safety Card||
1826|048|H|with you at all times during treatment and for 2 months after||
1826|049|H|your last dose of pegcetacoplan. Ask your health care||
1826|050|H|professional how to prepare and use this medication. If you have||
1826|051|H|any questions, ask your doctor or pharmacist.||
1826|052|H|   This medication is given by slow injection under the skin as||
1826|053|H|directed by your doctor, usually twice a week. The injection is||
1826|054|H|given using an infusion pump in the abdomen, thighs, hips, or||
1826|055|H|upper arms. The dosage is based on your medical condition, lab||
1826|056|H|tests, and response to treatment. Children's dosage is also based||
1826|057|H|on weight.||
1826|058|H|   Take the medication out of the refrigerator 30 minutes before||
1826|059|H|you inject it to allow it to reach room temperature. Do not warm||
1826|060|H|up this medication any other way (for example, do not heat it in||
1826|061|H|the microwave or place it in hot water). Before using, check this||
1826|062|H|product for particles or discoloration. If either is present, do||
1826|063|H|not use the liquid. Before injecting each dose, clean the skin||
1826|064|H|you are going to inject into (the injection site) with rubbing||
1826|065|H|alcohol. Change the injection site each time to lessen injury||
1826|066|H|under the skin. If more than one site is needed for your dose,||
1826|067|H|make sure they are at least 3 inches apart. Do not infuse into||
1826|068|H|skin that is tender, bruised, red, or hard, or has tattoos,||
1826|069|H|scars, or stretch marks. To lessen bruising, do not rub the||
1826|070|H|injection site after each dose. Learn how to store and discard||
1826|071|H|medical supplies safely.||
1826|072|H|   Infusion reactions may happen during the infusion of this||
1826|073|H|drug. Tell your doctor right away if you have any symptoms of||
1826|074|H|infusion reactions such chest discomfort/pain, shortness of||
1826|075|H|breath, feeling faint, or injection site itching, warmth,||
1826|076|H|redness, swelling, rash, or pain.||
1826|077|H|   Use this medication regularly to get the most benefit from it.||
1826|078|H|To help you remember, mark your calendar with a reminder. If you||
1826|079|H|are changing to this medication treatment from another drug,||
1826|080|H|carefully follow your doctor's directions for when to start or||
1826|081|H|stop this and your other medication(s). Do not stop using this||
1826|082|H|medication without consulting your doctor. Your condition may||
1826|083|H|become worse when the drug is stopped. If you do stop using this||
1826|084|H|medication, your doctor will monitor you for at least 8 weeks to||
1826|085|H|make sure your condition does not get worse. Consult your doctor||
1826|086|H|for more details.||
1826|087|H|   Tell your doctor if your condition does not get better or if||
1826|088|H|it gets worse.||
1826|089|B|||
1826|090|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1826|091|S|   Tiredness, headache, dizziness, diarrhea, abdominal pain, or||
1826|092|S|muscle/joint pain may occur. If any of these effects last or get||
1826|093|S|worse, tell your doctor or pharmacist promptly.||
1826|094|S|   Remember that this medication has been prescribed because your||
1826|095|S|doctor has judged that the benefit to you is greater than the||
1826|096|S|risk of side effects. Many people using this medication do not||
1826|097|S|have serious side effects.||
1826|098|S|   This medication may lower your ability to fight infections.||
1826|099|S|This may make you more likely to get a serious (rarely fatal)||
1826|100|S|infection or make any infection you have worse. Tell your doctor||
1826|101|S|right away if you have any signs of infection (such as sore||
1826|102|S|throat that doesn't go away, fever, chills).||
1826|103|S|   A very serious allergic reaction to this drug is rare.||
1826|104|S|However, get medical help right away if you notice any symptoms||
1826|105|S|of a serious allergic reaction, including: rash, itching/swelling||
1826|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1826|107|S|breathing.||
1826|108|S|   This is not a complete list of possible side effects. If you||
1826|109|S|notice other effects not listed above, contact your doctor or||
1826|110|S|pharmacist.||
1826|111|S|   In the US -||
1826|112|S|   Call your doctor for medical advice about side effects. You||
1826|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1826|114|S|www.fda.gov/medwatch.||
1826|115|S|   In Canada - Call your doctor for medical advice about side||
1826|116|S|effects. You may report side effects to Health Canada at||
1826|117|S|1-866-234-2345.||
1826|118|B|||
1826|119|P|PRECAUTIONS:  Before using pegcetacoplan, tell your doctor or||
1826|120|P|pharmacist if you are allergic to it; or if you have any other||
1826|121|P|allergies. This product may contain inactive ingredients, which||
1826|122|P|can cause allergic reactions or other problems. Talk to your||
1826|123|P|pharmacist for more details.||
1826|124|P|   Before using this medication, tell your doctor or pharmacist||
1826|125|P|your medical history, especially of: current/recent infection,||
1826|126|P|vaccinations.||
1826|127|P|   Pegcetacoplan can make you more likely to get certain||
1826|128|P|infections (such as flu, colds, meningitis). Talk to your doctor||
1826|129|P|for more details.||
1826|130|P|   Tell your doctor your vaccine history and ask if you need to||
1826|131|P|get any vaccines before starting treatment with this medication.||
1826|132|P|Tell your health care professional that you are using||
1826|133|P|pegcetacoplan before having any immunizations/vaccinations. Avoid||
1826|134|P|contact with people who have recently received live vaccines||
1826|135|P|(such as flu vaccine inhaled through the nose).||
1826|136|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1826|137|P|can make you more dizzy. Do not drive, use machinery, or do||
1826|138|P|anything that needs alertness until you can do it safely. Limit||
1826|139|P|alcoholic beverages. Talk to your doctor if you are using||
1826|140|P|marijuana (cannabis).||
1826|141|P|   Before having surgery, tell your doctor or dentist about all||
1826|142|P|the products you use (including prescription drugs,||
1826|143|P|nonprescription drugs, and herbal products).||
1826|144|P|   Tell your doctor if you are pregnant or plan to become||
1826|145|P|pregnant. You should not become pregnant while using||
1826|146|P|pegcetacoplan. Pegcetacoplan may harm an unborn baby. Your doctor||
1826|147|P|may order a pregnancy test before you start this medication. Ask||
1826|148|P|about reliable forms of birth control while using this medication||
1826|149|P|and for 40 days after the last dose. If you become pregnant, talk||
1826|150|P|to your doctor right away about the risks and benefits of this||
1826|151|P|medication.||
1826|152|P|   It is unknown if this drug passes into breast milk. Because of||
1826|153|P|the possible risk to the infant, breastfeeding is not recommended||
1826|154|P|while using this drug and for 40 days after the last dose.||
1826|155|P|Consult your doctor before breastfeeding.||
1826|156|B|||
1826|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1826|158|I|medications work or increase your risk for serious side effects.||
1826|159|I|This document does not contain all possible drug interactions.||
1826|160|I|Keep a list of all the products you use (including||
1826|161|I|prescription/nonprescription drugs and herbal products) and share||
1826|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
1826|163|I|the dosage of any medicines without your doctor's approval.||
1826|164|I|   This medication may interfere with certain lab tests, possibly||
1826|165|I|causing false test results. Make sure lab personnel and all your||
1826|166|I|doctors know you use this drug.||
1826|167|B|||
1826|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1826|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1826|170|O|poison control center right away. US residents can call||
1826|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1826|172|B|||
1826|173|N|NOTES:  Do not share this medication with others.||
1826|174|N|   Lab and/or medical tests (such as LDH levels, complete blood||
1826|175|N|count) should be done while you are using this medication and for||
1826|176|N|at least 8 weeks after stopping treatment. Keep all medical and||
1826|177|N|lab appointments.||
1826|178|B|||
1826|179|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1826|180|D|If it is near the time of the next dose, skip the missed dose.||
1826|181|D|Use your next dose at the regular time. Do not double the dose to||
1826|182|D|catch up.||
1826|183|B|||
1826|184|R|STORAGE:  Store in the refrigerator. Keep the medication in the||
1826|185|R|original container to protect from light. Keep all medications||
1826|186|R|away from children and pets.||
1826|187|R|   Do not flush medications down the toilet or pour them into a||
1826|188|R|drain unless instructed to do so. Properly discard this product||
1826|189|R|when it is expired or no longer needed. Consult your pharmacist||
1826|190|R|or local waste disposal company.||
1826|191|B|||
1826|192|M|MEDICAL ALERT:  Your condition can cause complications in a||
1826|193|M|medical emergency. For information about enrolling in MedicAlert,||
1826|194|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1826|195|B|||
1826|196|A|Information last revised September 2025.||
1826|197|A|Copyright(c) 2025 First Databank, Inc.||
1826|198|B|||
1827|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1827|002|Z|does NOT have all possible information about this product. This||
1827|003|Z|information does not assure that this product is safe, effective,||
1827|004|Z|or appropriate for you. This information is not individual||
1827|005|Z|medical advice and does not substitute for the advice of your||
1827|006|Z|health care professional. Always ask your health care||
1827|007|Z|professional for complete information about this product and your||
1827|008|Z|specific health needs.||
1827|009|B|||
1827|010|T|NIRAPARIB - ORAL||
1827|011|F|(nye-RAP-a-rib)||
1827|012|B|||
1827|013|C|COMMON BRAND NAME(S): Zejula||
1827|014|B|||
1827|015|U|USES:  Niraparib is used to treat ovarian cancer, fallopian tube||
1827|016|U|cancer, or a type of cancer of the abdomen (primary peritoneal||
1827|017|U|cancer). It works by slowing the growth of cancer cells.||
1827|018|B|||
1827|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1827|020|H|from your pharmacist before you start taking niraparib and each||
1827|021|H|time you get a refill. If you have any questions, ask your doctor||
1827|022|H|or pharmacist.||
1827|023|H|   Take this medication by mouth with or without food as directed||
1827|024|H|by your doctor, usually once daily. Taking this medication at||
1827|025|H|bedtime may help to reduce nausea. Swallow this medication whole.||
1827|026|H|Do not chew, crush, or split the medication.||
1827|027|H|   The dosage is based on your medical condition and response to||
1827|028|H|treatment.||
1827|029|H|   If you vomit after taking a dose, do not take another dose at||
1827|030|H|that time. Take your next dose at the regular time.||
1827|031|H|   Take this medication regularly to get the most benefit from||
1827|032|H|it. To help you remember, take it at the same time each day.||
1827|033|H|   Do not increase your dose or use this drug more often or for||
1827|034|H|longer than prescribed. Your condition will not improve any||
1827|035|H|faster, and your risk of serious side effects will increase.||
1827|036|B|||
1827|037|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, constipation,||
1827|038|S|bad taste in your mouth, dry mouth, mouth sores, dizziness,||
1827|039|S|headache, or trouble sleeping may occur. Rarely, nausea and||
1827|040|S|vomiting can be severe. Taking this medication at bedtime may||
1827|041|S|help reduce nausea. In some cases, your doctor may prescribe||
1827|042|S|medication to prevent or relieve nausea and vomiting. Eating||
1827|043|S|several small meals or limiting activity may help lessen nausea||
1827|044|S|and vomiting. If any of these effects last or get worse, tell||
1827|045|S|your doctor or pharmacist promptly.||
1827|046|S|   People using this medication may have serious side effects.||
1827|047|S|However, you have been prescribed this drug because your doctor||
1827|048|S|has judged that the benefit to you is greater than the risk of||
1827|049|S|side effects. Careful monitoring by your doctor may decrease your||
1827|050|S|risk.||
1827|051|S|   This medication may raise your blood pressure and heart rate.||
1827|052|S|Sometimes these effects can be serious. Check your blood pressure||
1827|053|S|and heart rate regularly and tell your doctor if the results are||
1827|054|S|high. Your doctor may control your blood pressure and heart rate||
1827|055|S|with medication.||
1827|056|S|   Tell your doctor right away if you have any serious side||
1827|057|S|effects, including: signs of kidney problems (such as change in||
1827|058|S|the amount of urine).||
1827|059|S|   This medication decreases bone marrow function, an effect that||
1827|060|S|may lead to a low number of blood cells such as red cells, white||
1827|061|S|cells, and platelets. This effect can cause anemia, decrease your||
1827|062|S|body's ability to fight an infection, or cause easy||
1827|063|S|bruising/bleeding. Rarely, this medication may also cause certain||
1827|064|S|cancers of the bone marrow or blood cells. Your doctor will||
1827|065|S|monitor your blood cell count. Tell your doctor right away if you||
1827|066|S|develop any of the following symptoms: signs of anemia (such as||
1827|067|S|unusual tiredness, pale skin, shortness of breath, fast||
1827|068|S|heartbeat), signs of infection (such as sore throat that doesn't||
1827|069|S|go away, fever, chills), easy bruising/bleeding (such as||
1827|070|S|pink/bloody urine, black/bloody stools), weakness, weight loss.||
1827|071|S|   Rarely, niraparib may cause a condition called PRES (posterior||
1827|072|S|reversible encephalopathy syndrome). Get medical help right away||
1827|073|S|if you develop a headache that doesn't go away, seizures, sudden||
1827|074|S|vision changes, mental/mood changes (such as confusion).||
1827|075|S|   A very serious allergic reaction to this drug is rare.||
1827|076|S|However, get medical help right away if you notice any symptoms||
1827|077|S|of a serious allergic reaction, including: rash, itching/swelling||
1827|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1827|079|S|breathing.||
1827|080|S|   This is not a complete list of possible side effects. If you||
1827|081|S|notice other effects not listed above, contact your doctor or||
1827|082|S|pharmacist.||
1827|083|S|   In the US -||
1827|084|S|   Call your doctor for medical advice about side effects. You||
1827|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1827|086|S|www.fda.gov/medwatch.||
1827|087|S|   In Canada - Call your doctor for medical advice about side||
1827|088|S|effects. You may report side effects to Health Canada at||
1827|089|S|1-866-234-2345.||
1827|090|B|||
1827|091|P|PRECAUTIONS:  Before taking niraparib, tell your doctor or||
1827|092|P|pharmacist if you are allergic to it; or if you have any other||
1827|093|P|allergies. This product may contain inactive ingredients (such as||
1827|094|P|tartrazine found in some brands), which can cause allergic||
1827|095|P|reactions or other problems. Talk to your pharmacist for more||
1827|096|P|details.||
1827|097|P|   Before using this medication, tell your doctor or pharmacist||
1827|098|P|your medical history, especially of: heart disease (such as chest||
1827|099|P|pain, irregular heartbeat), high blood pressure, liver disease.||
1827|100|P|   Niraparib can make you more likely to get infections or may||
1827|101|P|make current infections worse. Stay away from anyone who has an||
1827|102|P|infection that may easily spread (such as chickenpox, COVID-19,||
1827|103|P|measles, flu). Talk to your doctor if you have been exposed to an||
1827|104|P|infection or for more details.||
1827|105|P|   Tell your health care professional that you are using||
1827|106|P|niraparib before having any immunizations/vaccinations. Avoid||
1827|107|P|contact with people who have recently received live vaccines||
1827|108|P|(such as flu vaccine inhaled through the nose).||
1827|109|P|   To lower the chance of getting cut, bruised, or injured, use||
1827|110|P|caution with sharp objects like razors and nail cutters, and||
1827|111|P|avoid activities such as contact sports.||
1827|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1827|113|P|can make you more dizzy. Do not drive, use machinery, or do||
1827|114|P|anything that needs alertness until you can do it safely. Limit||
1827|115|P|alcoholic beverages. Talk to your doctor if you are using||
1827|116|P|marijuana (cannabis).||
1827|117|P|   Before having surgery, tell your doctor or dentist about all||
1827|118|P|the products you use (including prescription drugs,||
1827|119|P|nonprescription drugs, and herbal products).||
1827|120|P|   Tell your doctor if you are pregnant or plan to become||
1827|121|P|pregnant. You should not become pregnant while using niraparib.||
1827|122|P|Niraparib may harm an unborn baby. Your doctor should order a||
1827|123|P|pregnancy test before you start this medication. Ask about||
1827|124|P|reliable forms of birth control while using this medication and||
1827|125|P|for 6 months after the last dose. If you become pregnant, talk to||
1827|126|P|your doctor right away about the risks and benefits of this||
1827|127|P|medication.||
1827|128|P|   It is unknown if this drug passes into breast milk. Because of||
1827|129|P|the possible risk to the infant, breastfeeding is not recommended||
1827|130|P|while using this drug and for 1 month after the last dose.||
1827|131|P|Consult your doctor before breastfeeding.||
1827|132|B|||
1827|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1827|134|I|medications work or increase your risk for serious side effects.||
1827|135|I|This document does not contain all possible drug interactions.||
1827|136|I|Keep a list of all the products you use (including||
1827|137|I|prescription/nonprescription drugs and herbal products) and share||
1827|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
1827|139|I|the dosage of any medicines without your doctor's approval.||
1827|140|B|||
1827|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1827|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1827|143|O|poison control center right away. US residents can call||
1827|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1827|145|B|||
1827|146|N|NOTES:  Do not share this medication with others.||
1827|147|N|   Lab and/or medical tests (such as complete blood count, blood||
1827|148|N|pressure, heart rate, kidney/liver function) should be done while||
1827|149|N|you are taking this medication. Keep all medical and lab||
1827|150|N|appointments. Consult your doctor for more details.||
1827|151|B|||
1827|152|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1827|153|D|next dose at the regular time. Do not double the dose to catch||
1827|154|D|up.||
1827|155|B|||
1827|156|R|STORAGE:  Store at room temperature away from light and moisture.||
1827|157|R|Do not store in the bathroom. Store the tablets in the original||
1827|158|R|bottle. Keep all medications away from children and pets.||
1827|159|R|   Do not flush medications down the toilet or pour them into a||
1827|160|R|drain unless instructed to do so. Properly discard this product||
1827|161|R|when it is expired or no longer needed. Consult your pharmacist||
1827|162|R|or local waste disposal company.||
1827|163|B|||
1827|164|M|MEDICAL ALERT:  Your condition can cause complications in a||
1827|165|M|medical emergency. For information about enrolling in MedicAlert,||
1827|166|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1827|167|B|||
1827|168|A|Information last revised April 2025.||
1827|169|A|Copyright(c) 2025 First Databank, Inc.||
1827|170|B|||
1828|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1828|002|Z|does NOT have all possible information about this product. This||
1828|003|Z|information does not assure that this product is safe, effective,||
1828|004|Z|or appropriate for you. This information is not individual||
1828|005|Z|medical advice and does not substitute for the advice of your||
1828|006|Z|health care professional. Always ask your health care||
1828|007|Z|professional for complete information about this product and your||
1828|008|Z|specific health needs.||
1828|009|B|||
1828|010|T|DARATUMUMAB - INJECTION||
1828|011|F|(DAR-a-TOOM-ue-mab)||
1828|012|B|||
1828|013|C|COMMON BRAND NAME(S): Darzalex||
1828|014|B|||
1828|015|U|USES:  This medication is used to treat a certain type of cancer||
1828|016|U|(multiple myeloma). Daratumumab belongs to a class of drugs known||
1828|017|U|as monoclonal antibodies. It works by slowing or stopping the||
1828|018|U|growth of cancer cells.||
1828|019|B|||
1828|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1828|021|H|from your pharmacist before you start using daratumumab and each||
1828|022|H|time you receive this medication. If you have any questions, ask||
1828|023|H|your doctor or pharmacist.||
1828|024|H|   This medication is given by injection into a vein by a health||
1828|025|H|care professional. It is given as directed by your doctor on a||
1828|026|H|treatment schedule, usually once a week for the first 6 to 9||
1828|027|H|weeks (depending on your medical condition). Afterward, your||
1828|028|H|doctor may direct you to receive this medication less often.||
1828|029|H|Follow your doctor's treatment schedule carefully.||
1828|030|H|   Infusion reactions may happen during or soon after the||
1828|031|H|infusion of this drug. Your doctor may prescribe other||
1828|032|H|medications before and after each treatment to help prevent these||
1828|033|H|side effects. Get medical help right away if you have any||
1828|034|H|symptoms of infusion reactions such as itchy/runny nose, nausea,||
1828|035|H|vomiting, throat irritation, fast heartbeat, trouble breathing,||
1828|036|H|fever, cough, headache, chills, dizziness, or chest discomfort.||
1828|037|H|   The dosage is based on your medical condition, weight, and||
1828|038|H|response to treatment.||
1828|039|H|   To get the most benefit, do not miss any doses. To help you||
1828|040|H|remember, mark your calendar with a reminder.||
1828|041|B|||
1828|042|S|SIDE EFFECTS:  See also How to Use section.||
1828|043|S|   Tiredness, back pain, joint pain, diarrhea, or loss of||
1828|044|S|appetite may occur. If any of these effects last or get worse,||
1828|045|S|tell your doctor or pharmacist promptly.||
1828|046|S|   People using this medication may have serious side effects.||
1828|047|S|However, you have been prescribed this drug because your doctor||
1828|048|S|has judged that the benefit to you is greater than the risk of||
1828|049|S|side effects. Careful monitoring by your doctor may decrease your||
1828|050|S|risk.||
1828|051|S|   Tell your doctor right away if you have any serious side||
1828|052|S|effects, including: easy bruising/bleeding, numb/tingling skin,||
1828|053|S|swelling hands/ankles/feet, blurred vision, eye pain.||
1828|054|S|   This medication may lower your ability to fight infections.||
1828|055|S|This may make you more likely to get a serious (rarely fatal)||
1828|056|S|infection or make any infection you have worse. Tell your doctor||
1828|057|S|right away if you have any signs of infection (such as sore||
1828|058|S|throat that doesn't go away, fever, chills).||
1828|059|S|   A very serious allergic reaction to this drug is rare.||
1828|060|S|However, get medical help right away if you notice any symptoms||
1828|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1828|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1828|063|S|breathing.||
1828|064|S|   This is not a complete list of possible side effects. If you||
1828|065|S|notice other effects not listed above, contact your doctor or||
1828|066|S|pharmacist.||
1828|067|S|   In the US -||
1828|068|S|   Call your doctor for medical advice about side effects. You||
1828|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1828|070|S|www.fda.gov/medwatch.||
1828|071|S|   In Canada - Call your doctor for medical advice about side||
1828|072|S|effects. You may report side effects to Health Canada at||
1828|073|S|1-866-234-2345.||
1828|074|B|||
1828|075|P|PRECAUTIONS:  Before using daratumumab, tell your doctor or||
1828|076|P|pharmacist if you are allergic to it; or if you have any other||
1828|077|P|allergies. This product may contain inactive ingredients, which||
1828|078|P|can cause allergic reactions or other problems. Talk to your||
1828|079|P|pharmacist for more details.||
1828|080|P|   Before using this medication, tell your doctor or pharmacist||
1828|081|P|your medical history, especially of: chronic obstructive||
1828|082|P|pulmonary disease (COPD), liver disease (such as hepatitis B).||
1828|083|P|   Daratumumab can make you more likely to get infections or may||
1828|084|P|make current infections worse. Stay away from anyone who has an||
1828|085|P|infection that may easily spread (such as chickenpox, COVID-19,||
1828|086|P|measles, flu). Talk to your doctor if you have been exposed to an||
1828|087|P|infection or for more details.||
1828|088|P|   Tell your health care professional that you are using||
1828|089|P|daratumumab before having any immunizations/vaccinations. Avoid||
1828|090|P|contact with people who have recently received live vaccines||
1828|091|P|(such as flu vaccine inhaled through the nose).||
1828|092|P|   To lower the chance of getting cut, bruised, or injured, use||
1828|093|P|caution with sharp objects like razors and nail cutters, and||
1828|094|P|avoid activities such as contact sports.||
1828|095|P|   Before having surgery, tell your doctor or dentist about all||
1828|096|P|the products you use (including prescription drugs,||
1828|097|P|nonprescription drugs, and herbal products).||
1828|098|P|   Older adults may be at greater risk for serious infections||
1828|099|P|while using this drug.||
1828|100|P|   Tell your doctor if you are pregnant or plan to become||
1828|101|P|pregnant. You should not become pregnant while using daratumumab.||
1828|102|P|Daratumumab may harm an unborn baby. Ask about reliable forms of||
1828|103|P|birth control while using this medication and for 3 months after||
1828|104|P|the last dose. If you become pregnant, talk to your doctor right||
1828|105|P|away about the risks and benefits of this medication.||
1828|106|P|   It is unknown if this drug passes into breast milk. Consult||
1828|107|P|your doctor before breastfeeding.||
1828|108|B|||
1828|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1828|110|I|medications work or increase your risk for serious side effects.||
1828|111|I|This document does not contain all possible drug interactions.||
1828|112|I|Keep a list of all the products you use (including||
1828|113|I|prescription/nonprescription drugs and herbal products) and share||
1828|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
1828|115|I|the dosage of any medicines without your doctor's approval.||
1828|116|I|   This medication may interfere with certain lab tests (such as||
1828|117|I|Coombs' test), possibly causing false test results. Make sure lab||
1828|118|I|personnel and all your doctors know you use this drug.||
1828|119|B|||
1828|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1828|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1828|122|O|poison control center right away. US residents can call||
1828|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1828|124|B|||
1828|125|N|NOTES:  Do not share this medication with others.||
1828|126|N|   Lab and/or medical tests (such as complete blood count, test||
1828|127|N|for hepatitis B virus) should be done before you start using this||
1828|128|N|medication and while you are using it. Keep all medical and lab||
1828|129|N|appointments. Consult your doctor for more details.||
1828|130|B|||
1828|131|D|MISSED DOSE:  It is important to get each dose of this medication||
1828|132|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1828|133|D|right away for a new dosing schedule. Do not double the dose to||
1828|134|D|catch up.||
1828|135|B|||
1828|136|R|STORAGE:  Not applicable. This medication is given in a clinic||
1828|137|R|and will not be stored at home.||
1828|138|B|||
1828|139|M|MEDICAL ALERT:  Your condition can cause complications in a||
1828|140|M|medical emergency. For information about enrolling in MedicAlert,||
1828|141|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1828|142|B|||
1828|143|A|Information last revised April 2025.||
1828|144|A|Copyright(c) 2025 First Databank, Inc.||
1828|145|B|||
1829|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1829|002|Z|does NOT have all possible information about this product. This||
1829|003|Z|information does not assure that this product is safe, effective,||
1829|004|Z|or appropriate for you. This information is not individual||
1829|005|Z|medical advice and does not substitute for the advice of your||
1829|006|Z|health care professional. Always ask your health care||
1829|007|Z|professional for complete information about this product and your||
1829|008|Z|specific health needs.||
1829|009|B|||
1829|010|T|BRIGATINIB - ORAL||
1829|011|F|(bri-GA-ti-nib)||
1829|012|B|||
1829|013|C|COMMON BRAND NAME(S): Alunbrig||
1829|014|B|||
1829|015|U|USES:  Brigatinib is used to treat a certain type of lung cancer||
1829|016|U|(non-small cell lung cancer). It works by slowing or stopping the||
1829|017|U|growth of cancer cells.||
1829|018|B|||
1829|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1829|020|H|from your pharmacist before you start taking brigatinib and each||
1829|021|H|time you get a refill. If you have any questions, ask your doctor||
1829|022|H|or pharmacist.||
1829|023|H|   Take this medication by mouth with or without food as directed||
1829|024|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
1829|025|H|not crush or chew the tablets.||
1829|026|H|   The dosage is based on your medical condition, response to||
1829|027|H|treatment, lab tests, and other medications you may be taking. Be||
1829|028|H|sure to tell your doctor and pharmacist about all the products||
1829|029|H|you use (including prescription drugs, nonprescription drugs, and||
1829|030|H|herbal products). Your doctor may direct you to start this||
1829|031|H|medication at a lower dose for one week and may then increase||
1829|032|H|your dose. Follow your doctor's instructions carefully.||
1829|033|H|   If you vomit after taking a dose, do not take another dose at||
1829|034|H|that time. Take your next dose on your usual dosing schedule.||
1829|035|H|   Use this medication regularly to get the most benefit from it.||
1829|036|H|To help you remember, take it at the same time each day.||
1829|037|H|   Do not increase your dose or use this drug more often or for||
1829|038|H|longer than prescribed. Your condition will not improve any||
1829|039|H|faster, and your risk of side effects will increase.||
1829|040|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1829|041|H|using this medication unless your doctor or pharmacist says you||
1829|042|H|may do so safely. Grapefruit can increase the chance of side||
1829|043|H|effects with this medicine. Ask your doctor or pharmacist for||
1829|044|H|more details.||
1829|045|B|||
1829|046|S|SIDE EFFECTS:  Nausea/vomiting, diarrhea, decreased appetite,||
1829|047|S|abdominal pain, constipation, tiredness, dizziness, fever,||
1829|048|S|headache, trouble sleeping, or joint pain may occur. If any of||
1829|049|S|these effects last or get worse, tell your doctor or pharmacist||
1829|050|S|promptly.||
1829|051|S|   Remember that this medication has been prescribed because your||
1829|052|S|doctor has judged that the benefit to you is greater than the||
1829|053|S|risk of side effects. Many people using this medication do not||
1829|054|S|have serious side effects.||
1829|055|S|   This medication may raise your blood pressure. Check your||
1829|056|S|blood pressure regularly and tell your doctor if the results are||
1829|057|S|high.||
1829|058|S|   Tell your doctor right away if you have any serious side||
1829|059|S|effects, including: slow heartbeat, unusual tiredness, vision||
1829|060|S|changes (such as blurred vision, double vision), increased||
1829|061|S|thirst/urination, unusual muscle pain/tenderness/weakness,||
1829|062|S|numbness/tingling of arms/legs, signs of pancreatitis or liver||
1829|063|S|disease (such as nausea/vomiting that doesn't stop,||
1829|064|S|stomach/abdominal pain, dark urine, yellowing eyes/skin).||
1829|065|S|   Get medical help right away if you have any very serious side||
1829|066|S|effects, including: symptoms of new or worsening lung problems||
1829|067|S|(such as cough, shortness of breath, chest pain).||
1829|068|S|   A very serious allergic reaction to this drug is rare.||
1829|069|S|However, get medical help right away if you notice any symptoms||
1829|070|S|of a serious allergic reaction, including: rash, itching/swelling||
1829|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1829|072|S|breathing.||
1829|073|S|   This is not a complete list of possible side effects. If you||
1829|074|S|notice other effects not listed above, contact your doctor or||
1829|075|S|pharmacist.||
1829|076|S|   In the US -||
1829|077|S|   Call your doctor for medical advice about side effects. You||
1829|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1829|079|S|www.fda.gov/medwatch.||
1829|080|S|   In Canada - Call your doctor for medical advice about side||
1829|081|S|effects. You may report side effects to Health Canada at||
1829|082|S|1-866-234-2345.||
1829|083|B|||
1829|084|P|PRECAUTIONS:  Before taking brigatinib, tell your doctor or||
1829|085|P|pharmacist if you are allergic to it; or if you have any other||
1829|086|P|allergies. This product may contain inactive ingredients, which||
1829|087|P|can cause allergic reactions or other problems. Talk to your||
1829|088|P|pharmacist for more details.||
1829|089|P|   Before using this medication, tell your doctor or pharmacist||
1829|090|P|your medical history, especially of: high blood pressure, other||
1829|091|P|lung/breathing problems, heart disease (such as slow heartbeat),||
1829|092|P|disease of the pancreas (pancreatitis), liver disease, diabetes,||
1829|093|P|vision problems.||
1829|094|P|   This drug may make you dizzy or blur your vision. Alcohol or||
1829|095|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
1829|096|P|machinery, or do anything that needs alertness or clear vision||
1829|097|P|until you can do it safely. Limit alcoholic beverages. Talk to||
1829|098|P|your doctor if you are using marijuana (cannabis).||
1829|099|P|   This medication may make you more sensitive to the sun. Limit||
1829|100|P|your time in the sun during treatment and for at least 5 days||
1829|101|P|after stopping treatment. Avoid tanning booths and sunlamps. Use||
1829|102|P|sunscreen and wear protective clothing when outdoors. Tell your||
1829|103|P|doctor right away if you get sunburned or have skin||
1829|104|P|blisters/redness.||
1829|105|P|   Before having surgery, tell your doctor or dentist about all||
1829|106|P|the products you use (including prescription drugs,||
1829|107|P|nonprescription drugs, and herbal products).||
1829|108|P|   Tell your doctor if you are pregnant or plan to become||
1829|109|P|pregnant. You should not become pregnant while using brigatinib.||
1829|110|P|Brigatinib may harm an unborn baby. Your doctor should order a||
1829|111|P|pregnancy test before you start this medication. Women using this||
1829|112|P|medication should ask about reliable forms of birth control||
1829|113|P|during treatment and for 4 months after the last dose. Men using||
1829|114|P|this medication should ask about reliable forms of birth control||
1829|115|P|during treatment and for 3 months after the last dose. If you or||
1829|116|P|your partner becomes pregnant, talk to your doctor right away||
1829|117|P|about the risks and benefits of this medication.||
1829|118|P|   It is unknown if this drug passes into breast milk. Because of||
1829|119|P|the possible risk to the infant, breastfeeding is not recommended||
1829|120|P|while using this drug and for 1 week after the last dose. Consult||
1829|121|P|your doctor before breastfeeding.||
1829|122|B|||
1829|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1829|124|I|medications work or increase your risk for serious side effects.||
1829|125|I|This document does not contain all possible drug interactions.||
1829|126|I|Keep a list of all the products you use (including||
1829|127|I|prescription/nonprescription drugs and herbal products) and share||
1829|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
1829|129|I|the dosage of any medicines without your doctor's approval.||
1829|130|I|   Other medications can affect the removal of brigatinib from||
1829|131|I|your body, which may affect how brigatinib works. Examples||
1829|132|I|include rifamycins (such as rifabutin), St. John's wort, drugs||
1829|133|I|used to treat seizures (such as carbamazepine, phenytoin), among||
1829|134|I|others.||
1829|135|B|||
1829|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1829|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1829|138|O|poison control center right away. US residents can call||
1829|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1829|140|B|||
1829|141|N|NOTES:  Do not share this medication with others.||
1829|142|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
1829|143|N|blood sugar, amylase/lipase levels, creatinine phosphokinase,||
1829|144|N|liver function, complete blood count) should be done while you||
1829|145|N|are taking this medication. Keep all medical and lab||
1829|146|N|appointments. Consult your doctor for more details.||
1829|147|B|||
1829|148|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1829|149|D|next dose at the regular time. Do not double the dose to catch||
1829|150|D|up.||
1829|151|B|||
1829|152|R|STORAGE:  Store at room temperature away from light and moisture.||
1829|153|R|Do not store in the bathroom. Keep all medications away from||
1829|154|R|children and pets.||
1829|155|R|   Do not flush medications down the toilet or pour them into a||
1829|156|R|drain unless instructed to do so. Properly discard this product||
1829|157|R|when it is expired or no longer needed. Consult your pharmacist||
1829|158|R|or local waste disposal company.||
1829|159|B|||
1829|160|A|Information last revised May 2024.||
1829|161|A|Copyright(c) 2025 First Databank, Inc.||
1829|162|B|||
1830|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1830|002|Z|does NOT have all possible information about this product. This||
1830|003|Z|information does not assure that this product is safe, effective,||
1830|004|Z|or appropriate for you. This information is not individual||
1830|005|Z|medical advice and does not substitute for the advice of your||
1830|006|Z|health care professional. Always ask your health care||
1830|007|Z|professional for complete information about this product and your||
1830|008|Z|specific health needs.||
1830|009|B|||
1830|010|T|VALBENAZINE - ORAL||
1830|011|F|(val-BEN-a-zeen)||
1830|012|B|||
1830|013|C|COMMON BRAND NAME(S): Ingrezza||
1830|014|B|||
1830|015|W|WARNING:  If you have Huntington's disease, valbenazine can||
1830|016|W|sometimes increase the risk of depression and suicidal||
1830|017|W|thoughts/attempts. People with Huntington's disease are already||
1830|018|W|more likely to have depression and suicidal thoughts/attempts.||
1830|019|W|Talk with your doctor about the risks and benefits of this||
1830|020|W|medication. Tell your doctor right away if you or your||
1830|021|W|family/caregivers notice that you have new/worsening symptoms of||
1830|022|W|depression, sadness, loss of interest in activities you used to||
1830|023|W|enjoy, suicidal thoughts/attempts, or other mental/mood/behavior||
1830|024|W|changes (such as new/worsening anxiety, panic attacks, trouble||
1830|025|W|sleeping, irritability, hostile/angry feelings).||
1830|026|B|||
1830|027|U|USES:  Valbenazine is used to treat involuntary movements of the||
1830|028|U|face, tongue, or other body parts (tardive dyskinesia). This||
1830|029|U|medication is also used to decrease the involuntary movements||
1830|030|U|(chorea) caused by Huntington's disease. Reducing involuntary||
1830|031|U|movements will help you take part in more of your normal daily||
1830|032|U|activities. This medication is thought to work by decreasing the||
1830|033|U|amount of certain natural substances in the brain that affect how||
1830|034|U|your nerves and muscles work (monoamines such as dopamine,||
1830|035|U|serotonin, and norepinephrine).||
1830|036|B|||
1830|037|H|HOW TO USE:  Read the Medication Guide provided by your||
1830|038|H|pharmacist before you start using valbenazine and each time you||
1830|039|H|get a refill. If you have any questions, ask your doctor or||
1830|040|H|pharmacist.||
1830|041|H|   Take this medication by mouth with or without food as directed||
1830|042|H|by your doctor, usually once daily. To reduce your risk of side||
1830|043|H|effects, your doctor may direct you to start this medication at a||
1830|044|H|low dose and gradually increase your dose. Follow your doctor's||
1830|045|H|instructions carefully.||
1830|046|H|   The dosage is based on your medical condition, response to||
1830|047|H|treatment, and other medications you may be taking. Be sure to||
1830|048|H|tell your doctor and pharmacist about all the products you use||
1830|049|H|(including prescription drugs, nonprescription drugs, and herbal||
1830|050|H|products).||
1830|051|H|   Take this medication regularly to get the most benefit from||
1830|052|H|it. To help you remember, take it at the same time each day.||
1830|053|H|   Tell your doctor if your condition does not get better or if||
1830|054|H|it gets worse.||
1830|055|B|||
1830|056|S|SIDE EFFECTS:  See also Warning section.||
1830|057|S|   Drowsiness, dizziness, restlessness, or vomiting may occur. If||
1830|058|S|any of these effects last or get worse, tell your doctor or||
1830|059|S|pharmacist promptly.||
1830|060|S|   To reduce the risk of dizziness and lightheadedness, get up||
1830|061|S|slowly when rising from a sitting or lying position.||
1830|062|S|   Remember that this medication has been prescribed because your||
1830|063|S|doctor has judged that the benefit to you is greater than the||
1830|064|S|risk of side effects. Many people using this medication do not||
1830|065|S|have serious side effects.||
1830|066|S|   Sometimes valbenazine can cause side effects that are similar||
1830|067|S|to the symptoms of worsening Huntington's disease. Your doctor||
1830|068|S|may need to adjust your dose to see if these side effects are due||
1830|069|S|to the drug or to the disease. Tell your doctor right away if any||
1830|070|S|of these serious side effects occur: shaking/tremors, slowed||
1830|071|S|movement, loss of balance, trouble swallowing.||
1830|072|S|   This medication may rarely cause a very serious condition||
1830|073|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1830|074|S|right away if you have any of the following symptoms: fever,||
1830|075|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1830|076|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1830|077|S|signs of kidney problems (such as change in the amount of urine).||
1830|078|S|   A very serious allergic reaction to this drug is rare.||
1830|079|S|However, get medical help right away if you notice any symptoms||
1830|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1830|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1830|082|S|breathing.||
1830|083|S|   This is not a complete list of possible side effects. If you||
1830|084|S|notice other effects not listed above, contact your doctor or||
1830|085|S|pharmacist.||
1830|086|S|   In the US -||
1830|087|S|   Call your doctor for medical advice about side effects. You||
1830|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1830|089|S|www.fda.gov/medwatch.||
1830|090|S|   In Canada - Call your doctor for medical advice about side||
1830|091|S|effects. You may report side effects to Health Canada at||
1830|092|S|1-866-234-2345.||
1830|093|B|||
1830|094|P|PRECAUTIONS:  See also Warning section.||
1830|095|P|   Before taking valbenazine, tell your doctor or pharmacist if||
1830|096|P|you are allergic to it; or if you have any other allergies. This||
1830|097|P|product may contain inactive ingredients, which can cause||
1830|098|P|allergic reactions or other problems. Talk to your pharmacist for||
1830|099|P|more details.||
1830|100|P|   Before using this medication, tell your doctor or pharmacist||
1830|101|P|your medical history, especially of: liver problems.||
1830|102|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1830|103|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1830|104|P|machinery, or do anything that needs alertness until you can do||
1830|105|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1830|106|P|are using marijuana (cannabis).||
1830|107|P|   Valbenazine may cause a condition that affects the heart||
1830|108|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1830|109|P|serious (rarely fatal) fast/irregular heartbeat and other||
1830|110|P|symptoms (such as severe dizziness, fainting) that need medical||
1830|111|P|attention right away.||
1830|112|P|   The risk of QT prolongation may be increased if you have||
1830|113|P|certain medical conditions or are taking other drugs that may||
1830|114|P|cause QT prolongation. Before using valbenazine, tell your doctor||
1830|115|P|or pharmacist of all the drugs you take and if you have any of||
1830|116|P|the following conditions: certain heart problems (heart failure,||
1830|117|P|slow heartbeat, QT prolongation in the EKG), family history of||
1830|118|P|certain heart problems (QT prolongation in the EKG, sudden||
1830|119|P|cardiac death).||
1830|120|P|   Low levels of potassium or magnesium in the blood may also||
1830|121|P|increase your risk of QT prolongation. This risk may increase if||
1830|122|P|you use certain drugs (such as diuretics/"water pills") or if you||
1830|123|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1830|124|P|Talk to your doctor about using valbenazine safely.||
1830|125|P|   Before having surgery, tell your doctor or dentist about all||
1830|126|P|the products you use (including prescription drugs,||
1830|127|P|nonprescription drugs, and herbal products).||
1830|128|P|   Older adults may be more sensitive to the side effects of this||
1830|129|P|drug, especially QT prolongation (see above).||
1830|130|P|   During pregnancy, this medication should be used only when||
1830|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
1830|132|P|   It is unknown if this drug passes into breast milk.||
1830|133|P|Breastfeeding is not recommended while using this drug and for 5||
1830|134|P|days after the last dose. Consult your doctor before||
1830|135|P|breastfeeding.||
1830|136|B|||
1830|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1830|138|I|medications work or increase your risk for serious side effects.||
1830|139|I|This document does not contain all possible drug interactions.||
1830|140|I|Keep a list of all the products you use (including||
1830|141|I|prescription/nonprescription drugs and herbal products) and share||
1830|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
1830|143|I|the dosage of any medicines without your doctor's approval.||
1830|144|I|   Some products that may interact with this drug are:||
1830|145|I|deutetrabenazine, tetrabenazine.||
1830|146|I|   Other medications can affect the removal of valbenazine from||
1830|147|I|your body, which may affect how valbenazine works. Examples||
1830|148|I|include rifamycins (such as rifabutin, rifampin), drugs used to||
1830|149|I|treat seizures (such as carbamazepine, phenytoin), St. John's||
1830|150|I|wort, among others.||
1830|151|I|   Taking MAO inhibitors with this medication may cause a serious||
1830|152|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
1830|153|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1830|154|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1830|155|I|selegiline, tranylcypromine) during treatment with this||
1830|156|I|medication. Most MAO inhibitors should also not be taken for two||
1830|157|I|weeks before and after treatment with this medication. Ask your||
1830|158|I|doctor when to start or stop taking this medication.||
1830|159|B|||
1830|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1830|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1830|162|O|poison control center right away. US residents can call||
1830|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1830|164|B|||
1830|165|N|NOTES:  Do not share this medication with others.||
1830|166|B|||
1830|167|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1830|168|D|remember. If it is near the time of the next dose, skip the||
1830|169|D|missed dose. Take your next dose at the regular time. Do not||
1830|170|D|double the dose to catch up.||
1830|171|B|||
1830|172|R|STORAGE:  Store at room temperature away from light and moisture.||
1830|173|R|Do not store in the bathroom. Keep all medications away from||
1830|174|R|children and pets.||
1830|175|R|   Do not flush medications down the toilet or pour them into a||
1830|176|R|drain unless instructed to do so. Properly discard this product||
1830|177|R|when it is expired or no longer needed. Consult your pharmacist||
1830|178|R|or local waste disposal company.||
1830|179|B|||
1830|180|A|Information last revised May 2024.||
1830|181|A|Copyright(c) 2025 First Databank, Inc.||
1830|182|B|||
1831|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1831|002|Z|does NOT have all possible information about this product. This||
1831|003|Z|information does not assure that this product is safe, effective,||
1831|004|Z|or appropriate for you. This information is not individual||
1831|005|Z|medical advice and does not substitute for the advice of your||
1831|006|Z|health care professional. Always ask your health care||
1831|007|Z|professional for complete information about this product and your||
1831|008|Z|specific health needs.||
1831|009|B|||
1831|010|T|ABALOPARATIDE - INJECTION||
1831|011|F|(a-BAL-oh-PAR-a-tide)||
1831|012|B|||
1831|013|C|COMMON BRAND NAME(S): Tymlos||
1831|014|B|||
1831|015|U|USES:  Abaloparatide is used to treat bone loss (osteoporosis) in||
1831|016|U|people who have a high risk of getting fractures. It is similar||
1831|017|U|to a natural hormone in your body (parathyroid hormone). It works||
1831|018|U|by increasing bone mass and strength. This effect helps to||
1831|019|U|decrease the risk of getting a fracture.||
1831|020|U|   This medication should not be used for children or young||
1831|021|U|adults whose bones are still growing.||
1831|022|B|||
1831|023|H|HOW TO USE:  Read the Medication Guide and Instructions For Use||
1831|024|H|provided by your pharmacist before you start using abaloparatide||
1831|025|H|and each time you get a refill. Ask your health care professional||
1831|026|H|how to prepare and use this medication. If you have any||
1831|027|H|questions, ask your doctor or pharmacist.||
1831|028|H|   Inject this medication under the skin as directed by your||
1831|029|H|doctor, usually once daily. The injection is given in the||
1831|030|H|abdomen. When you give the first several doses, make sure you are||
1831|031|H|in a place where you can sit or lie down if you have dizziness.||
1831|032|H|   Before using, check this product for particles or||
1831|033|H|discoloration. If either is present, do not use the liquid.||
1831|034|H|Before injecting each dose, clean the skin you are going to||
1831|035|H|inject into (the injection site) with rubbing alcohol. Change the||
1831|036|H|injection site each time to lessen injury under the skin. To||
1831|037|H|lessen bruising, do not rub the injection site after a shot.||
1831|038|H|Learn how to store and discard medical supplies safely.||
1831|039|H|   Use this medication regularly to get the most benefit from it.||
1831|040|H|To help you remember, use it at the same time each day.||
1831|041|B|||
1831|042|S|SIDE EFFECTS:  Dizziness or fast heartbeat may occur within 4||
1831|043|S|hours after using this medication. If these effects occur, sit or||
1831|044|S|lie down right away. These symptoms usually go away within a few||
1831|045|S|hours. These effects should go away after several doses as your||
1831|046|S|body adjusts to the medication. Redness/pain/swelling at the||
1831|047|S|injection site may also occur. If any of these effects last or||
1831|048|S|get worse, tell your doctor or pharmacist promptly.||
1831|049|S|   To reduce the risk of dizziness and lightheadedness, get up||
1831|050|S|slowly when rising from a sitting or lying position.||
1831|051|S|   Remember that this medication has been prescribed because your||
1831|052|S|doctor has judged that the benefit to you is greater than the||
1831|053|S|risk of side effects. Many people using this medication do not||
1831|054|S|have serious side effects.||
1831|055|S|   Tell your doctor right away if you have any serious side||
1831|056|S|effects, including: signs of a high level of calcium in the blood||
1831|057|S|(such as nausea, vomiting, constipation, unusual tiredness,||
1831|058|S|muscle weakness, mental/mood changes including confusion).||
1831|059|S|   Abaloparatide has been shown to increase bone cancer||
1831|060|S|(osteosarcoma) in rats. It is unknown if this medication can||
1831|061|S|cause bone cancer in humans. Tell your doctor right away if you||
1831|062|S|have any symptoms of bone cancer, including: bone pain, unusual||
1831|063|S|growths/lumps.||
1831|064|S|   A very serious allergic reaction to this drug is rare.||
1831|065|S|However, get medical help right away if you notice any symptoms||
1831|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1831|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1831|068|S|breathing.||
1831|069|S|   This is not a complete list of possible side effects. If you||
1831|070|S|notice other effects not listed above, contact your doctor or||
1831|071|S|pharmacist.||
1831|072|S|   In the US -||
1831|073|S|   Call your doctor for medical advice about side effects. You||
1831|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1831|075|S|www.fda.gov/medwatch.||
1831|076|S|   In Canada - Call your doctor for medical advice about side||
1831|077|S|effects. You may report side effects to Health Canada at||
1831|078|S|1-866-234-2345.||
1831|079|B|||
1831|080|P|PRECAUTIONS:  Before using abaloparatide, tell your doctor or||
1831|081|P|pharmacist if you are allergic to it; or if you have any other||
1831|082|P|allergies. This product may contain inactive ingredients, which||
1831|083|P|can cause allergic reactions or other problems. Talk to your||
1831|084|P|pharmacist for more details.||
1831|085|P|   Before using this medication, tell your doctor or pharmacist||
1831|086|P|your medical history, especially of: other bone disorders (such||
1831|087|P|as bone cancer, Paget's disease), radiation treatment, high level||
1831|088|P|of calcium in the blood, kidney stones, kidney disease, high||
1831|089|P|level of parathyroid hormone.||
1831|090|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1831|091|P|can make you more dizzy. Do not drive, use machinery, or do||
1831|092|P|anything that needs alertness until you can do it safely. Limit||
1831|093|P|alcoholic beverages. Talk to your doctor if you are using||
1831|094|P|marijuana (cannabis).||
1831|095|P|   Before having surgery, tell your doctor or dentist about all||
1831|096|P|the products you use (including prescription drugs,||
1831|097|P|nonprescription drugs, and herbal products).||
1831|098|P|   This medication is not usually used in women of childbearing||
1831|099|P|age. It is unlikely to be used during pregnancy or breastfeeding.||
1831|100|P|Consult your doctor if you have any questions about this||
1831|101|P|medication.||
1831|102|B|||
1831|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1831|104|I|medications work or increase your risk for serious side effects.||
1831|105|I|This document does not contain all possible drug interactions.||
1831|106|I|Keep a list of all the products you use (including||
1831|107|I|prescription/nonprescription drugs and herbal products) and share||
1831|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
1831|109|I|the dosage of any medicines without your doctor's approval.||
1831|110|B|||
1831|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1831|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1831|113|O|poison control center right away. US residents can call||
1831|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1831|115|O|Symptoms of overdose may include: nausea, vomiting, severe||
1831|116|O|dizziness, unusual tiredness, headache.||
1831|117|B|||
1831|118|N|NOTES:  Do not share this medication with others.||
1831|119|N|   Lab and/or medical tests (such as blood calcium level, bone||
1831|120|N|density) should be done while you are using this medication. Keep||
1831|121|N|all medical and lab appointments.||
1831|122|N|   Lifestyle changes that help promote healthy bones include||
1831|123|N|increasing weight-bearing exercise, stopping smoking, limiting||
1831|124|N|alcohol, and eating well-balanced meals that contain adequate||
1831|125|N|calcium and vitamin D. You may also need to take calcium and||
1831|126|N|vitamin D supplements. Consult your doctor for specific advice.||
1831|127|B|||
1831|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1831|129|D|If you don't remember until the next day, skip the missed dose.||
1831|130|D|Use your next dose at the regular time. Do not double the dose to||
1831|131|D|catch up.||
1831|132|B|||
1831|133|R|STORAGE:  Store unopened pens in the refrigerator. Do not freeze.||
1831|134|R|After the first use of a pen, store it at room temperature away||
1831|135|R|from heat. This medication expires 30 days after the pen is first||
1831|136|R|used. Keep all medications away from children and pets.||
1831|137|R|   Do not flush medications down the toilet or pour them into a||
1831|138|R|drain unless instructed to do so. Properly discard this product||
1831|139|R|when it is expired or no longer needed. Consult your pharmacist||
1831|140|R|or local waste disposal company.||
1831|141|B|||
1831|142|A|Information last revised October 2024.||
1831|143|A|Copyright(c) 2025 First Databank, Inc.||
1831|144|B|||
1832|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1832|002|Z|does NOT have all possible information about this product. This||
1832|003|Z|information does not assure that this product is safe, effective,||
1832|004|Z|or appropriate for you. This information is not individual||
1832|005|Z|medical advice and does not substitute for the advice of your||
1832|006|Z|health care professional. Always ask your health care||
1832|007|Z|professional for complete information about this product and your||
1832|008|Z|specific health needs.||
1832|009|B|||
1832|010|T|MIDOSTAURIN - ORAL||
1832|011|F|(MYE-doe-STAW-rin)||
1832|012|B|||
1832|013|C|COMMON BRAND NAME(S): Rydapt||
1832|014|B|||
1832|015|U|USES:  Midostaurin is used to treat certain types of blood cell||
1832|016|U|cancer (acute myeloid leukemia-AML, mast cell leukemia-MCL) or an||
1832|017|U|immune system disorder (mastocytosis). It works by slowing or||
1832|018|U|stopping the growth of cancer cells and certain immune system||
1832|019|U|cells (mast cells).||
1832|020|B|||
1832|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1832|022|H|from your pharmacist before you start taking midostaurin and each||
1832|023|H|time you get a refill. If you have any questions, ask your doctor||
1832|024|H|or pharmacist.||
1832|025|H|   Take this medication by mouth with food as directed by your||
1832|026|H|doctor, usually twice daily (every 12 hours). Swallow the||
1832|027|H|capsules whole. Do not open or crush the capsules.||
1832|028|H|   The dosage is based on your medical condition and response to||
1832|029|H|treatment. For certain conditions, you may not need to take this||
1832|030|H|medication every day (for example, some people are directed to||
1832|031|H|take the medication for 2 weeks, then stop for 2 weeks). Follow||
1832|032|H|your doctor's instructions carefully.||
1832|033|H|   Your doctor should instruct you to take other medications to||
1832|034|H|prevent nausea and vomiting. Take those medications as directed.||
1832|035|H|   If you vomit after taking a dose, do not take another dose at||
1832|036|H|that time. Take your next dose on your usual dosing schedule.||
1832|037|H|   Use this medication regularly to get the most benefit from it.||
1832|038|H|To help you remember, take it at the same times each day.||
1832|039|H|   Do not increase your dose or use this drug more often or for||
1832|040|H|longer than prescribed. Your condition will not improve any||
1832|041|H|faster, and your risk of serious side effects will increase.||
1832|042|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1832|043|H|using this medication unless your doctor or pharmacist says you||
1832|044|H|may do so safely. Grapefruit can increase the chance of side||
1832|045|H|effects with this medicine. Ask your doctor or pharmacist for||
1832|046|H|more details.||
1832|047|B|||
1832|048|S|SIDE EFFECTS:  Nausea/vomiting, diarrhea, stomach/abdominal pain,||
1832|049|S|mouth sores, constipation, hemorrhoids, headache, dizziness,||
1832|050|S|tiredness, muscle/joint pain, or trouble sleeping may occur. If||
1832|051|S|any of these effects last or get worse, tell your doctor or||
1832|052|S|pharmacist promptly.||
1832|053|S|   Remember that this medication has been prescribed because your||
1832|054|S|doctor has judged that the benefit to you is greater than the||
1832|055|S|risk of side effects. Many people using this medication do not||
1832|056|S|have serious side effects.||
1832|057|S|   Tell your doctor right away if you have any serious side||
1832|058|S|effects, including: increased thirst/urination, signs of kidney||
1832|059|S|problems (such as change in the amount of urine), signs of||
1832|060|S|infection (such as sore throat that doesn't go away, fever,||
1832|061|S|chills), easy bruising/bleeding, unusual tiredness, vomit that is||
1832|062|S|bloody or looks like coffee grounds, black/tarry stool.||
1832|063|S|   Get medical help right away if you have any very serious side||
1832|064|S|effects, including: symptoms of lung problems (such as cough,||
1832|065|S|shortness of breath, chest pain), fast/irregular heartbeat,||
1832|066|S|severe dizziness, fainting.||
1832|067|S|   A very serious allergic reaction to this drug is rare.||
1832|068|S|However, get medical help right away if you notice any symptoms||
1832|069|S|of a serious allergic reaction, including: rash, itching/swelling||
1832|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1832|071|S|breathing.||
1832|072|S|   This is not a complete list of possible side effects. If you||
1832|073|S|notice other effects not listed above, contact your doctor or||
1832|074|S|pharmacist.||
1832|075|S|   In the US -||
1832|076|S|   Call your doctor for medical advice about side effects. You||
1832|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1832|078|S|www.fda.gov/medwatch.||
1832|079|S|   In Canada - Call your doctor for medical advice about side||
1832|080|S|effects. You may report side effects to Health Canada at||
1832|081|S|1-866-234-2345.||
1832|082|B|||
1832|083|P|PRECAUTIONS:  Before taking midostaurin, tell your doctor or||
1832|084|P|pharmacist if you are allergic to it; or if you have any other||
1832|085|P|allergies. This product may contain inactive ingredients, which||
1832|086|P|can cause allergic reactions or other problems. Talk to your||
1832|087|P|pharmacist for more details.||
1832|088|P|   Before using this medication, tell your doctor or pharmacist||
1832|089|P|your medical history, especially of: lung/breathing problems.||
1832|090|P|   Midostaurin may cause a condition that affects the heart||
1832|091|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1832|092|P|serious (rarely fatal) fast/irregular heartbeat and other||
1832|093|P|symptoms (such as severe dizziness, fainting) that need medical||
1832|094|P|attention right away.||
1832|095|P|   The risk of QT prolongation may be increased if you have||
1832|096|P|certain medical conditions or are taking other drugs that may||
1832|097|P|cause QT prolongation. Before using midostaurin, tell your doctor||
1832|098|P|or pharmacist of all the drugs you take and if you have any of||
1832|099|P|the following conditions: certain heart problems (heart failure,||
1832|100|P|slow heartbeat, QT prolongation in the EKG), family history of||
1832|101|P|certain heart problems (QT prolongation in the EKG, sudden||
1832|102|P|cardiac death).||
1832|103|P|   Low levels of potassium or magnesium in the blood may also||
1832|104|P|increase your risk of QT prolongation. This risk may increase if||
1832|105|P|you use certain drugs (such as diuretics/"water pills") or if you||
1832|106|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1832|107|P|Talk to your doctor about using midostaurin safely.||
1832|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1832|109|P|can make you more dizzy. Do not drive, use machinery, or do||
1832|110|P|anything that needs alertness until you can do it safely. Limit||
1832|111|P|alcoholic beverages. Talk to your doctor if you are using||
1832|112|P|marijuana (cannabis).||
1832|113|P|   Before having surgery, tell your doctor or dentist about all||
1832|114|P|the products you use (including prescription drugs,||
1832|115|P|nonprescription drugs, and herbal products).||
1832|116|P|   Older adults may be more sensitive to the side effects of this||
1832|117|P|drug, especially QT prolongation (see above).||
1832|118|P|   Tell your doctor if you are pregnant or plan to become||
1832|119|P|pregnant. You should not become pregnant while using midostaurin.||
1832|120|P|Midostaurin may harm an unborn baby. Your doctor should order a||
1832|121|P|pregnancy test within 7 days before you start this medication.||
1832|122|P|Men and women using this medication should ask about reliable||
1832|123|P|forms of birth control during treatment and for 4 months after||
1832|124|P|the last dose. If you or your partner becomes pregnant, talk to||
1832|125|P|your doctor right away about the risks and benefits of this||
1832|126|P|medication.||
1832|127|P|   It is unknown if this drug passes into breast milk. Because of||
1832|128|P|the possible risk to the infant, breastfeeding is not recommended||
1832|129|P|while using this drug and for 4 months after the last dose.||
1832|130|P|Consult your doctor before breastfeeding.||
1832|131|B|||
1832|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1832|133|I|medications work or increase your risk for serious side effects.||
1832|134|I|This document does not contain all possible drug interactions.||
1832|135|I|Keep a list of all the products you use (including||
1832|136|I|prescription/nonprescription drugs and herbal products) and share||
1832|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
1832|138|I|the dosage of any medicines without your doctor's approval.||
1832|139|I|   Other medications can affect the removal of midostaurin from||
1832|140|I|your body, which may affect how midostaurin works. Examples||
1832|141|I|include rifamycins (such as rifabutin), St. John's wort, drugs||
1832|142|I|used to treat seizures (such as carbamazepine, phenytoin), among||
1832|143|I|others.||
1832|144|B|||
1832|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1832|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1832|147|O|poison control center right away. US residents can call||
1832|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1832|149|B|||
1832|150|N|NOTES:  Do not share this medication with others.||
1832|151|N|   Lab and/or medical tests (such as liver function, complete||
1832|152|N|blood count, blood mineral levels) should be done while you are||
1832|153|N|taking this medication. Keep all medical and lab appointments.||
1832|154|N|Consult your doctor for more details.||
1832|155|B|||
1832|156|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1832|157|D|next dose at the regular time. Do not double the dose to catch||
1832|158|D|up.||
1832|159|B|||
1832|160|R|STORAGE:  Store in the original package at room temperature away||
1832|161|R|from light and moisture. Do not store in the bathroom. Keep all||
1832|162|R|medications away from children and pets.||
1832|163|R|   Do not flush medications down the toilet or pour them into a||
1832|164|R|drain unless instructed to do so. Properly discard this product||
1832|165|R|when it is expired or no longer needed. Consult your pharmacist||
1832|166|R|or local waste disposal company.||
1832|167|B|||
1832|168|A|Information last revised April 2025.||
1832|169|A|Copyright(c) 2025 First Databank, Inc.||
1832|170|B|||
1833|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1833|002|Z|does NOT have all possible information about this product. This||
1833|003|Z|information does not assure that this product is safe, effective,||
1833|004|Z|or appropriate for you. This information is not individual||
1833|005|Z|medical advice and does not substitute for the advice of your||
1833|006|Z|health care professional. Always ask your health care||
1833|007|Z|professional for complete information about this product and your||
1833|008|Z|specific health needs.||
1833|009|B|||
1833|010|T|DURVALUMAB - INJECTION||
1833|011|F|(dur-VAL-ue-mab)||
1833|012|B|||
1833|013|C|COMMON BRAND NAME(S): Imfinzi||
1833|014|B|||
1833|015|U|USES:  Durvalumab is used to treat certain cancers (such as lung,||
1833|016|U|biliary tract, liver, bladder). This medication is also used to||
1833|017|U|treat cancer of the uterus lining (endometrial cancer). It works||
1833|018|U|by helping your immune system fight the cancer. This medication||
1833|019|U|belongs to a class of drugs known as monoclonal antibodies.||
1833|020|B|||
1833|021|H|HOW TO USE:  Read the Medication Guide provided by your||
1833|022|H|pharmacist before you start receiving durvalumab and each time||
1833|023|H|you get a treatment. If you have any questions, ask your doctor||
1833|024|H|or pharmacist.||
1833|025|H|   This medication is given by a health care professional. It is||
1833|026|H|injected slowly into a vein over 60 minutes as directed by your||
1833|027|H|doctor, usually once every 2 to 4 weeks. The dosage and treatment||
1833|028|H|schedule are based on your medical condition, weight, and||
1833|029|H|response to treatment.||
1833|030|H|   Infusion reactions may happen during the infusion of this||
1833|031|H|drug. Your doctor may prescribe other medications before each||
1833|032|H|treatment to help prevent these side effects. Tell your doctor||
1833|033|H|right away if you have any symptoms of infusion reactions such as||
1833|034|H|chills, flushing, itching, dizziness, or shortness of breath.||
1833|035|H|Your doctor may give you other medications to help with these||
1833|036|H|side effects or may slow down or stop your treatment for some||
1833|037|H|time.||
1833|038|H|   To get the most benefit, do not miss any doses. To help you||
1833|039|H|remember, mark your calendar with a reminder.||
1833|040|B|||
1833|041|S|SIDE EFFECTS:  See also How to Use section.||
1833|042|S|   Tiredness, loss of appetite, nausea, constipation, muscle/bone||
1833|043|S|pain, or swelling hands/ankles/feet may occur. If any of these||
1833|044|S|effects last or get worse, tell your doctor or pharmacist||
1833|045|S|promptly.||
1833|046|S|   People using this medication may have serious side effects.||
1833|047|S|However, you have been prescribed this drug because your doctor||
1833|048|S|has judged that the benefit to you is greater than the risk of||
1833|049|S|side effects. Careful monitoring by your doctor may decrease your||
1833|050|S|risk.||
1833|051|S|   Tell your doctor right away if you have any serious side||
1833|052|S|effects, including: signs of liver disease (such as||
1833|053|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
1833|054|S|yellowing eyes/skin, dark urine), new/worsening cough, diarrhea,||
1833|055|S|blood/mucus in your stool, eye/vision problems (such as blurred||
1833|056|S|vision, vision changes, eye pain), headache that is severe or||
1833|057|S|doesn't go away, stiff/painful neck, unusual weight gain/loss,||
1833|058|S|mental/mood changes (such as confusion), cold or heat||
1833|059|S|intolerance, fast/slow/pounding/irregular heartbeat, increased||
1833|060|S|thirst/urination, muscle weakness, numbness/tingling of||
1833|061|S|arms/legs, easy bruising/bleeding, burning/painful/urgent||
1833|062|S|urination, signs of kidney problems (such as pink/bloody urine,||
1833|063|S|change in the amount of urine).||
1833|064|S|   Get medical help right away if you have any very serious side||
1833|065|S|effects, including: chest pain, shortness of breath.||
1833|066|S|   A very serious allergic reaction to this drug is rare.||
1833|067|S|However, get medical help right away if you notice any symptoms||
1833|068|S|of a serious allergic reaction, including: fever, swollen lymph||
1833|069|S|nodes, rash, itching/swelling (especially of the||
1833|070|S|face/tongue/throat), severe dizziness, trouble breathing.||
1833|071|S|   This is not a complete list of possible side effects. If you||
1833|072|S|notice other effects not listed above, contact your doctor or||
1833|073|S|pharmacist.||
1833|074|S|   In the US -||
1833|075|S|   Call your doctor for medical advice about side effects. You||
1833|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1833|077|S|www.fda.gov/medwatch.||
1833|078|S|   In Canada - Call your doctor for medical advice about side||
1833|079|S|effects. You may report side effects to Health Canada at||
1833|080|S|1-866-234-2345.||
1833|081|B|||
1833|082|P|PRECAUTIONS:  Before using durvalumab, tell your doctor or||
1833|083|P|pharmacist if you are allergic to it; or if you have any other||
1833|084|P|allergies. This product may contain inactive ingredients, which||
1833|085|P|can cause allergic reactions or other problems. Talk to your||
1833|086|P|pharmacist for more details.||
1833|087|P|   Before using this medication, tell your doctor or pharmacist||
1833|088|P|your medical history, especially of: organ transplant, stem cell||
1833|089|P|transplant with donor cells.||
1833|090|P|   Durvalumab can make you more likely to get infections or may||
1833|091|P|make current infections worse. Stay away from anyone who has an||
1833|092|P|infection that may easily spread (such as chickenpox, COVID-19,||
1833|093|P|measles, flu). Talk to your doctor if you have been exposed to an||
1833|094|P|infection or for more details.||
1833|095|P|   Tell your health care professional that you are using||
1833|096|P|durvalumab before having any immunizations/vaccinations. Avoid||
1833|097|P|contact with people who have recently received live vaccines||
1833|098|P|(such as flu vaccine inhaled through the nose).||
1833|099|P|   Before having surgery, tell your doctor or dentist about all||
1833|100|P|the products you use (including prescription drugs,||
1833|101|P|nonprescription drugs, and herbal products).||
1833|102|P|   Tell your doctor if you are pregnant or plan to become||
1833|103|P|pregnant. You should not become pregnant while using durvalumab.||
1833|104|P|Durvalumab may harm an unborn baby. Your doctor should order a||
1833|105|P|pregnancy test before you start this medication. Ask about||
1833|106|P|reliable forms of birth control while using this medication and||
1833|107|P|for at least 3 months after the last dose. If you become||
1833|108|P|pregnant, talk to your doctor right away about the risks and||
1833|109|P|benefits of this medication.||
1833|110|P|   It is unknown if this drug passes into breast milk. Because of||
1833|111|P|the possible risk to the infant, breastfeeding is not recommended||
1833|112|P|while using this drug and for at least 3 months after the last||
1833|113|P|dose. Consult your doctor before breastfeeding.||
1833|114|B|||
1833|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1833|116|I|medications work or increase your risk for serious side effects.||
1833|117|I|This document does not contain all possible drug interactions.||
1833|118|I|Keep a list of all the products you use (including||
1833|119|I|prescription/nonprescription drugs and herbal products) and share||
1833|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1833|121|I|the dosage of any medicines without your doctor's approval.||
1833|122|B|||
1833|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1833|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1833|125|O|poison control center right away. US residents can call||
1833|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1833|127|B|||
1833|128|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
1833|129|N|function) should be done while you are using this medication.||
1833|130|N|Keep all medical and lab appointments.||
1833|131|B|||
1833|132|D|MISSED DOSE:  It is important to get each dose of this medication||
1833|133|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1833|134|D|right away for a new dosing schedule.||
1833|135|B|||
1833|136|R|STORAGE:  Not applicable. This medication is given in a hospital||
1833|137|R|or clinic and will not be stored at home.||
1833|138|B|||
1833|139|A|Information last revised March 2025.||
1833|140|A|Copyright(c) 2025 First Databank, Inc.||
1833|141|B|||
1834|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1834|002|Z|does NOT have all possible information about this product. This||
1834|003|Z|information does not assure that this product is safe, effective,||
1834|004|Z|or appropriate for you. This information is not individual||
1834|005|Z|medical advice and does not substitute for the advice of your||
1834|006|Z|health care professional. Always ask your health care||
1834|007|Z|professional for complete information about this product and your||
1834|008|Z|specific health needs.||
1834|009|B|||
1834|010|T|RITUXIMAB - SUBCUTANEOUS INJECTION||
1834|011|F|(ri-TUX-i-mab)||
1834|012|B|||
1834|013|C|COMMON BRAND NAME(S): Rituxan Hycela||
1834|014|B|||
1834|015|W|WARNING:  Rituximab may rarely cause serious (sometimes fatal)||
1834|016|W|side effects including severe breathing problems or heart||
1834|017|W|problems (such as heart attack, irregular heartbeat). If these||
1834|018|W|serious side effects occur, they usually happen after the first||
1834|019|W|treatment (IV infusion) with rituximab. Get medical help right||
1834|020|W|away if you have trouble breathing, itching, swelling (especially||
1834|021|W|of the throat/lips), dizziness, fast/slow/irregular heartbeat, or||
1834|022|W|chest pain.||
1834|023|W|   Rarely, people using this medication have had serious||
1834|024|W|(sometimes fatal) skin reactions (such as Stevens-Johnson||
1834|025|W|syndrome). Get medical help right away if you develop rash,||
1834|026|W|blisters, peeling skin, or sores on your skin, lips, or in your||
1834|027|W|mouth.||
1834|028|W|   This medication may increase your risk of getting a rare but||
1834|029|W|very serious (possibly fatal) brain infection (progressive||
1834|030|W|multifocal leukoencephalopathy-PML). Get medical help right away||
1834|031|W|if you have any of these side effects: clumsiness, loss of||
1834|032|W|coordination/balance, weakness, sudden change in your thinking||
1834|033|W|(such as confusion, difficulty concentrating, memory loss),||
1834|034|W|difficulty talking/walking, seizure, vision changes.||
1834|035|W|   Rituximab may cause serious (possibly fatal) liver disease in||
1834|036|W|people who have current or past infection with hepatitis B.||
1834|037|W|Before starting this medication, tell your doctor if you have||
1834|038|W|ever had hepatitis B. Your doctor should do a blood test for||
1834|039|W|hepatitis B before starting treatment. Tell your doctor right||
1834|040|W|away if you have new or worsening symptoms of liver disease, such||
1834|041|W|as nausea/vomiting that doesn't stop, loss of appetite,||
1834|042|W|stomach/abdominal pain, dark urine, or yellowing eyes/skin.||
1834|043|B|||
1834|044|U|USES:  Rituximab is used to treat certain types of cancer (such||
1834|045|U|as non-Hodgkin's lymphoma, chronic lymphocytic leukemia).||
1834|046|U|Rituximab belongs to a class of drugs known as monoclonal||
1834|047|U|antibodies. It works by slowing or stopping the growth of cancer||
1834|048|U|cells.||
1834|049|B|||
1834|050|H|HOW TO USE:  Read the Medication Guide provided by your||
1834|051|H|pharmacist before you start using rituximab and each time you get||
1834|052|H|a refill. If you have any questions, ask your doctor or||
1834|053|H|pharmacist.||
1834|054|H|   Your doctor will prescribe other medications (such as||
1834|055|H|acetaminophen, an antihistamine, methylprednisolone) for you to||
1834|056|H|take before each treatment to help reduce side effects, such as||
1834|057|H|fever and chills. Carefully follow your doctor's instructions.||
1834|058|H|   This medication is given by injection under the skin of your||
1834|059|H|abdomen by a health care professional. It is given as directed by||
1834|060|H|your doctor, usually over 5 to 7 minutes. This form of rituximab||
1834|061|H|is used only after receiving your first dose of rituximab by||
1834|062|H|injection into a vein. The dosage and treatment schedule are||
1834|063|H|based on your medical condition, other medications you may be||
1834|064|H|taking, and response to treatment.||
1834|065|H|   Ask your doctor if you should take your regular medications||
1834|066|H|(such as drugs for high blood pressure) before your treatment.||
1834|067|B|||
1834|068|S|SIDE EFFECTS:  See also Warning section.||
1834|069|S|   Pain, swelling, bruising, redness, or itching at the injection||
1834|070|S|site may occur. Headache, nausea, weakness, or dizziness may also||
1834|071|S|occur. If any of these effects last or get worse, tell your||
1834|072|S|doctor or pharmacist promptly.||
1834|073|S|   People using this medication may have serious side effects.||
1834|074|S|However, you have been prescribed this drug because your doctor||
1834|075|S|has judged that the benefit to you is greater than the risk of||
1834|076|S|side effects. Careful monitoring by your doctor may decrease your||
1834|077|S|risk.||
1834|078|S|   Tell your doctor right away if you have any serious side||
1834|079|S|effects, including: signs of stomach/intestinal blockage (such as||
1834|080|S|vomiting that doesn't stop, stomach/abdominal pain), increased||
1834|081|S|thirst/urination, swelling of the hands/feet, tingling of the||
1834|082|S|hands/feet.||
1834|083|S|   Rituximab sometimes causes side effects due to the rapid||
1834|084|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1834|085|S|risk, your doctor may add a medication and tell you to drink||
1834|086|S|plenty of fluids. Tell your doctor right away if you have||
1834|087|S|symptoms such as: low back/side pain (flank pain), signs of||
1834|088|S|kidney problems (such as painful urination, pink/bloody urine,||
1834|089|S|change in the amount of urine), muscle spasms/weakness.||
1834|090|S|   This medication can decrease blood cells, which can cause||
1834|091|S|bleeding problems and lower your ability to fight infections.||
1834|092|S|This may make you more likely to get a serious (rarely fatal)||
1834|093|S|infection or make any infection you have worse. Tell your doctor||
1834|094|S|right away if you develop any of the following side effects: easy||
1834|095|S|bleeding/bruising, black/tarry stools, vomit that looks like||
1834|096|S|coffee grounds, signs of an infection (such as sore throat that||
1834|097|S|doesn't go away, fever, chills).||
1834|098|S|   A very serious allergic reaction to this drug is rare.||
1834|099|S|However, get medical help right away if you notice any symptoms||
1834|100|S|of a serious allergic reaction, including: rash, itching/swelling||
1834|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1834|102|S|breathing.||
1834|103|S|   This is not a complete list of possible side effects. If you||
1834|104|S|notice other effects not listed above, contact your doctor or||
1834|105|S|pharmacist.||
1834|106|S|   In the US -||
1834|107|S|   Call your doctor for medical advice about side effects. You||
1834|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1834|109|S|www.fda.gov/medwatch.||
1834|110|S|   In Canada - Call your doctor for medical advice about side||
1834|111|S|effects. You may report side effects to Health Canada at||
1834|112|S|1-866-234-2345.||
1834|113|B|||
1834|114|P|PRECAUTIONS:  Before using rituximab, tell your doctor or||
1834|115|P|pharmacist if you are allergic to it; or if you have any other||
1834|116|P|allergies. This product may contain inactive ingredients, which||
1834|117|P|can cause allergic reactions or other problems. Talk to your||
1834|118|P|pharmacist for more details.||
1834|119|P|   Before using this medication, tell your doctor or pharmacist||
1834|120|P|your medical history, especially of: bleeding/blood problems,||
1834|121|P|heart problems (such as irregular heartbeat, previous heart||
1834|122|P|attack), current/recent infections, lung problems, stroke.||
1834|123|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1834|124|P|can make you more dizzy. Do not drive, use machinery, or do||
1834|125|P|anything that needs alertness until you can do it safely. Limit||
1834|126|P|alcoholic beverages. Talk to your doctor if you are using||
1834|127|P|marijuana (cannabis).||
1834|128|P|   Rituximab can make you more likely to get infections or may||
1834|129|P|make current infections worse. Stay away from anyone who has an||
1834|130|P|infection that may easily spread (such as chickenpox, COVID-19,||
1834|131|P|measles, flu). Talk to your doctor if you have been exposed to an||
1834|132|P|infection or for more details.||
1834|133|P|   Tell your health care professional that you are using||
1834|134|P|rituximab before having any immunizations/vaccinations. Avoid||
1834|135|P|contact with people who have recently received live vaccines||
1834|136|P|(such as flu vaccine inhaled through the nose).||
1834|137|P|   To lower the chance of getting cut, bruised, or injured, use||
1834|138|P|caution with sharp objects like razors and nail cutters, and||
1834|139|P|avoid activities such as contact sports.||
1834|140|P|   Before having surgery, tell your doctor or dentist about all||
1834|141|P|the products you use (including prescription drugs,||
1834|142|P|nonprescription drugs, and herbal products).||
1834|143|P|   Older adults may be at greater risk for heart problems (such||
1834|144|P|as irregular heartbeat) or lung problems while using this drug.||
1834|145|P|   Tell your doctor if you are pregnant or plan to become||
1834|146|P|pregnant. You should not become pregnant while using rituximab.||
1834|147|P|Rituximab may harm an unborn baby. Your doctor should order a||
1834|148|P|pregnancy test before you start this medication. Ask about||
1834|149|P|reliable forms of birth control while using this medication and||
1834|150|P|for 1 year after the last dose. If you become pregnant, talk to||
1834|151|P|your doctor right away about the risks and benefits of this||
1834|152|P|medication.||
1834|153|P|   This drug passes into breast milk. Because of the possible||
1834|154|P|risk to the infant, breastfeeding is not recommended while using||
1834|155|P|this drug and for at least 6 months after the last dose. Consult||
1834|156|P|your doctor before breastfeeding.||
1834|157|B|||
1834|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1834|159|I|medications work or increase your risk for serious side effects.||
1834|160|I|This document does not contain all possible drug interactions.||
1834|161|I|Keep a list of all the products you use (including||
1834|162|I|prescription/nonprescription drugs and herbal products) and share||
1834|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
1834|164|I|the dosage of any medicines without your doctor's approval.||
1834|165|I|   Some products that may interact with this drug are: other||
1834|166|I|drugs that weaken the immune system/increase the risk of||
1834|167|I|infection (such as natalizumab, fingolimod, tofacitinib).||
1834|168|B|||
1834|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1834|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1834|171|O|poison control center right away. US residents can call||
1834|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1834|173|B|||
1834|174|N|NOTES:  Lab and/or medical tests (such as blood counts, hepatitis||
1834|175|N|B virus, kidney/liver function) should be done before you start||
1834|176|N|using this medication and while you are using it. Keep all||
1834|177|N|medical and lab appointments.||
1834|178|B|||
1834|179|D|MISSED DOSE:  It is important to get each dose of this medication||
1834|180|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1834|181|D|right away for a new dosing schedule.||
1834|182|B|||
1834|183|R|STORAGE:  Not applicable. This medication is given in a hospital||
1834|184|R|or clinic or doctor's office and will not be stored at home.||
1834|185|B|||
1834|186|M|MEDICAL ALERT:  Your condition can cause complications in a||
1834|187|M|medical emergency. For information about enrolling in MedicAlert,||
1834|188|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1834|189|B|||
1834|190|A|Information last revised April 2025.||
1834|191|A|Copyright(c) 2025 First Databank, Inc.||
1834|192|B|||
1835|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1835|002|Z|does NOT have all possible information about this product. This||
1835|003|Z|information does not assure that this product is safe, effective,||
1835|004|Z|or appropriate for you. This information is not individual||
1835|005|Z|medical advice and does not substitute for the advice of your||
1835|006|Z|health care professional. Always ask your health care||
1835|007|Z|professional for complete information about this product and your||
1835|008|Z|specific health needs.||
1835|009|B|||
1835|010|T|RIBOCICLIB/LETROZOLE - ORAL||
1835|011|F|(RYE-boe-SYE-klib/LET-roe-zole)||
1835|012|B|||
1835|013|C|COMMON BRAND NAME(S): Kisqali Femara Co-Pack||
1835|014|B|||
1835|015|U|USES:  This product contains 2 medications: ribociclib tablets||
1835|016|U|and letrozole tablets. This product is used to treat breast||
1835|017|U|cancer. Ribociclib works by slowing or stopping the growth of||
1835|018|U|cancer cells. Letrozole works by decreasing the amount of||
1835|019|U|estrogen the body makes, which helps slow down or reverse the||
1835|020|U|growth of some breast cancers.||
1835|021|B|||
1835|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1835|023|H|from your pharmacist before you start taking ribociclib and||
1835|024|H|letrozole tablets and each time you get a refill. If you have any||
1835|025|H|questions, ask your doctor or pharmacist.||
1835|026|H|   Take ribociclib by mouth with or without food as directed by||
1835|027|H|your doctor, usually once daily in the morning for 21 days, then||
1835|028|H|stopping the medication for 7 days. Take letrozole by mouth with||
1835|029|H|or without food as directed by your doctor, usually once daily in||
1835|030|H|the morning for 28 days. This is one cycle of treatment. Keep||
1835|031|H|taking these medications this way as directed by your doctor.||
1835|032|H|   Swallow the tablets whole. Do not crush, chew, or break the||
1835|033|H|tablets. Also, do not take a tablet that is damaged or broken.||
1835|034|H|   If you vomit after taking a dose, do not take another dose on||
1835|035|H|that day. Take your next dose at the regular time.||
1835|036|H|   The dosage is based on your medical condition, response to||
1835|037|H|treatment, lab tests, and other medications you may be taking. Be||
1835|038|H|sure to tell your doctor and pharmacist about all the products||
1835|039|H|you use (including prescription drugs, nonprescription drugs, and||
1835|040|H|herbal products).||
1835|041|H|   Use these medications regularly to get the most benefit from||
1835|042|H|them. To help you remember, take them at the same time(s) each||
1835|043|H|day.||
1835|044|H|   Do not increase your dose or use these drugs more often or for||
1835|045|H|longer than prescribed. Your condition will not improve any||
1835|046|H|faster, and your risk of serious side effects will increase.||
1835|047|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1835|048|H|taking these medications unless your doctor or pharmacist says||
1835|049|H|you may do so safely. Grapefruit can increase the chance of side||
1835|050|H|effects with ribociclib. Ask your doctor or pharmacist for more||
1835|051|H|details.||
1835|052|H|   Since these drugs can be absorbed through the skin and lungs||
1835|053|H|and may harm an unborn baby, women who are pregnant or who may||
1835|054|H|become pregnant should not handle these medications or breathe||
1835|055|H|the dust from the tablets.||
1835|056|B|||
1835|057|S|SIDE EFFECTS:  Tiredness, nausea, loss of appetite, vomiting,||
1835|058|S|diarrhea, headache, constipation, back pain, hot flashes, unusual||
1835|059|S|sweating, dizziness, or trouble sleeping may occur. Nausea and||
1835|060|S|vomiting can be severe. In some cases, your doctor may prescribe||
1835|061|S|medication to prevent or relieve nausea and vomiting. Eating||
1835|062|S|several small meals, not eating before treatment, or limiting||
1835|063|S|activity may help lessen some of these effects. If any of these||
1835|064|S|effects last or get worse, tell your doctor or pharmacist||
1835|065|S|promptly.||
1835|066|S|   Temporary hair loss may occur. Normal hair growth should||
1835|067|S|return after treatment has ended.||
1835|068|S|   Pain or sores in the mouth and throat may occur. Brush your||
1835|069|S|teeth carefully/gently, avoid using mouthwash that contains||
1835|070|S|alcohol, and rinse your mouth often with cool water mixed with||
1835|071|S|baking soda or salt. It may also be best to eat soft, moist||
1835|072|S|foods.||
1835|073|S|   People using these medications may have serious side effects.||
1835|074|S|However, you have been prescribed these drugs because your doctor||
1835|075|S|has judged that the benefit to you is greater than the risk of||
1835|076|S|side effects. Careful monitoring by your doctor may decrease your||
1835|077|S|risk.||
1835|078|S|   Tell your doctor right away if you have any serious side||
1835|079|S|effects, including: bone fractures, pain/swelling of the||
1835|080|S|joint/muscle/tendon, mental/mood changes (such as depression,||
1835|081|S|anxiety), swelling of arms/legs, signs of liver disease (such as||
1835|082|S|nausea/vomiting that doesn't stop, loss of appetite,||
1835|083|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1835|084|S|   Get medical help right away if you have any very serious side||
1835|085|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1835|086|S|fainting.||
1835|087|S|   Letrozole may rarely cause serious (sometimes fatal) problems||
1835|088|S|from blood clots (such as heart attack, stroke, blood clots in||
1835|089|S|the lungs or legs). Get medical help right away if you have:||
1835|090|S|shortness of breath/rapid breathing, chest/jaw/left arm pain,||
1835|091|S|confusion, pain/swelling/warmth in the groin/calf, sudden/severe||
1835|092|S|headaches, trouble speaking, weakness on one side of the body,||
1835|093|S|sudden vision changes, unusual sweating, sudden||
1835|094|S|dizziness/fainting.||
1835|095|S|   This product may lower your ability to fight infections. This||
1835|096|S|may make you more likely to get a serious (rarely fatal)||
1835|097|S|infection or make any infection you have worse. Get medical help||
1835|098|S|right away if you have any signs of infection (such as sore||
1835|099|S|throat that doesn't go away, fever, swollen lymph nodes, chills).||
1835|100|S|   A very serious allergic reaction to these drugs is rare.||
1835|101|S|However, get medical help right away if you notice any symptoms||
1835|102|S|of a serious allergic reaction, including: rash, itching/swelling||
1835|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1835|104|S|breathing.||
1835|105|S|   This is not a complete list of possible side effects. If you||
1835|106|S|notice other effects not listed above, contact your doctor or||
1835|107|S|pharmacist.||
1835|108|S|   In the US -||
1835|109|S|   Call your doctor for medical advice about side effects. You||
1835|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1835|111|S|www.fda.gov/medwatch.||
1835|112|S|   In Canada - Call your doctor for medical advice about side||
1835|113|S|effects. You may report side effects to Health Canada at||
1835|114|S|1-866-234-2345.||
1835|115|B|||
1835|116|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1835|117|P|pharmacist if you are allergic to ribociclib or letrozole; or if||
1835|118|P|you have any other allergies. This product may contain inactive||
1835|119|P|ingredients, which can cause allergic reactions or other||
1835|120|P|problems. Talk to your pharmacist for more details.||
1835|121|P|   Before using these medications, tell your doctor or pharmacist||
1835|122|P|your medical history, especially of: high cholesterol, bone||
1835|123|P|problems (such as osteoporosis), heart problems (such as angina,||
1835|124|P|previous heart attack), liver disease, kidney disease.||
1835|125|P|   These drugs may make you tired or dizzy. Alcohol or marijuana||
1835|126|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
1835|127|P|or do anything that needs alertness until you can do it safely.||
1835|128|P|Limit alcoholic beverages. Talk to your doctor if you are using||
1835|129|P|marijuana (cannabis).||
1835|130|P|   Ribociclib may cause a condition that affects the heart rhythm||
1835|131|P|(QT prolongation). QT prolongation can rarely cause serious||
1835|132|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1835|133|P|as severe dizziness, fainting) that need medical attention right||
1835|134|P|away.||
1835|135|P|   The risk of QT prolongation may be increased if you have||
1835|136|P|certain medical conditions or are taking other drugs that may||
1835|137|P|cause QT prolongation. Before using ribociclib, tell your doctor||
1835|138|P|or pharmacist of all the drugs you take and if you have any of||
1835|139|P|the following conditions: certain heart problems (heart failure,||
1835|140|P|slow heartbeat, QT prolongation in the EKG), family history of||
1835|141|P|certain heart problems (QT prolongation in the EKG, sudden||
1835|142|P|cardiac death).||
1835|143|P|   Low levels of potassium or magnesium in the blood may also||
1835|144|P|increase your risk of QT prolongation. This risk may increase if||
1835|145|P|you use certain drugs (such as diuretics "water pills") or if you||
1835|146|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1835|147|P|Talk to your doctor about using ribociclib safely.||
1835|148|P|   Ribociclib can make you more likely to get infections or may||
1835|149|P|make current infections worse. Stay away from anyone who has an||
1835|150|P|infection that may easily spread (such as chickenpox, COVID-19,||
1835|151|P|measles, flu). Talk to your doctor if you have been exposed to an||
1835|152|P|infection or for more details.||
1835|153|P|   Tell your health care professional that you are using this||
1835|154|P|medication before having any immunizations/vaccinations. Avoid||
1835|155|P|contact with people who have recently received live vaccines||
1835|156|P|(such as flu vaccine inhaled through the nose).||
1835|157|P|   Before having surgery, tell your doctor or dentist about all||
1835|158|P|the products you use (including prescription drugs,||
1835|159|P|nonprescription drugs, and herbal products).||
1835|160|P|   Older adults may be more sensitive to the side effects of||
1835|161|P|these drugs, especially QT prolongation (see above).||
1835|162|P|   Tell your doctor if you are pregnant or plan to become||
1835|163|P|pregnant. You should not become pregnant while using ribociclib||
1835|164|P|and letrozole. Ribociclib/letrozole may harm an unborn baby. Your||
1835|165|P|doctor should order a pregnancy test before your start these||
1835|166|P|medications. Ask about reliable forms of birth control while||
1835|167|P|using these medications and for 3 weeks after the last dose. If||
1835|168|P|you become pregnant, talk to your doctor right away about the||
1835|169|P|risks and benefits of these medications.||
1835|170|P|   Since these drugs can be absorbed through the skin and lungs||
1835|171|P|and may harm an unborn baby, women who are pregnant or who may||
1835|172|P|become pregnant should not handle these medications or breathe||
1835|173|P|the dust from the tablets.||
1835|174|P|   It is unknown if this medication passes into breast milk.||
1835|175|P|Because of the possible risk to the infant, breastfeeding is not||
1835|176|P|recommended while using this medication and for at least 3 weeks||
1835|177|P|after the last dose. Consult your doctor before breastfeeding.||
1835|178|B|||
1835|179|I|DRUG INTERACTIONS:  See also How to Use section.||
1835|180|I|   Drug interactions may change how your medications work or||
1835|181|I|increase your risk for serious side effects. This document does||
1835|182|I|not contain all possible drug interactions. Keep a list of all||
1835|183|I|the products you use (including prescription/nonprescription||
1835|184|I|drugs and herbal products) and share it with your doctor and||
1835|185|I|pharmacist. Do not start, stop, or change the dosage of any||
1835|186|I|medicines without your doctor's approval.||
1835|187|I|   Some products that may interact with these drugs are:||
1835|188|I|estrogens (such as estradiol), tamoxifen, tibolone.||
1835|189|I|   Other medications can affect the removal of ribociclib from||
1835|190|I|your body, which may affect how ribociclib works. Examples||
1835|191|I|include lonafarnib, rifamycins (such as rifampin, rifabutin), St.||
1835|192|I|John's wort, drugs used to treat seizures (such as carbamazepine,||
1835|193|I|phenytoin), among others.||
1835|194|I|   Ribociclib can slow down the removal of other medications from||
1835|195|I|your body, which may affect how they work. Examples of affected||
1835|196|I|drugs include alprazolam, eplerenone, ergot alkaloids (such as||
1835|197|I|ergotamine), estazolam, flibanserin, irinotecan, ivabradine,||
1835|198|I|mavacamten, naloxegol, ticagrelor, tolvaptan, triazolam, among||
1835|199|I|others.||
1835|200|I|   Many drugs besides ribociclib may affect the heart rhythm (QT||
1835|201|I|prolongation), such as amiodarone, chloroquine, clarithromycin,||
1835|202|I|domperidone, dronedarone, haloperidol, methadone, moxifloxacin,||
1835|203|I|pacritinib, pimozide, ranolazine, among others.||
1835|204|B|||
1835|205|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1835|206|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1835|207|O|poison control center right away. US residents can call||
1835|208|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1835|209|B|||
1835|210|N|NOTES:  Do not share these medications with others.||
1835|211|N|   Lab and/or medical tests (such as EKG, liver function,||
1835|212|N|complete blood count, bone density, cholesterol, potassium and||
1835|213|N|magnesium blood levels) should be done before you start taking||
1835|214|N|these medications and while you are taking them. Keep all medical||
1835|215|N|and lab appointments. Consult your doctor for more details.||
1835|216|B|||
1835|217|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1835|218|D|next dose at the regular time. Do not double the dose to catch||
1835|219|D|up.||
1835|220|B|||
1835|221|R|STORAGE:  Store in the original container at room temperature||
1835|222|R|away from light and moisture for up to 2 months. Do not store in||
1835|223|R|the bathroom. Keep all medications away from children and pets.||
1835|224|R|   Do not flush medications down the toilet or pour them into a||
1835|225|R|drain unless instructed to do so. Properly discard this product||
1835|226|R|when it is expired or no longer needed. Consult your pharmacist||
1835|227|R|or local waste disposal company.||
1835|228|B|||
1835|229|M|MEDICAL ALERT:  Your condition can cause complications in a||
1835|230|M|medical emergency. For information about enrolling in MedicAlert,||
1835|231|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1835|232|B|||
1835|233|A|Information last revised April 2025.||
1835|234|A|Copyright(c) 2025 First Databank, Inc.||
1835|235|B|||
1836|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1836|002|Z|does NOT have all possible information about this product. This||
1836|003|Z|information does not assure that this product is safe, effective,||
1836|004|Z|or appropriate for you. This information is not individual||
1836|005|Z|medical advice and does not substitute for the advice of your||
1836|006|Z|health care professional. Always ask your health care||
1836|007|Z|professional for complete information about this product and your||
1836|008|Z|specific health needs.||
1836|009|B|||
1836|010|T|SAFINAMIDE - ORAL||
1836|011|F|(sa-FIN-a-mide)||
1836|012|B|||
1836|013|C|COMMON BRAND NAME(S): Xadago||
1836|014|B|||
1836|015|U|USES:  Safinamide is used with another medication||
1836|016|U|(levodopa/carbidopa) to treat symptoms of Parkinson's disease. It||
1836|017|U|can help improve symptoms such as shakiness, stiffness, and||
1836|018|U|difficulty moving. It can also help reduce the amount of "off"||
1836|019|U|time (periods of slow movement or stiffness).||
1836|020|U|   Safinamide belongs to a class of drugs known as MAO||
1836|021|U|inhibitors. It works by increasing the levels of certain natural||
1836|022|U|substances in the brain (such as dopamine). Parkinson's disease||
1836|023|U|is thought to be caused by too little dopamine in the brain.||
1836|024|B|||
1836|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1836|026|H|from your pharmacist before you start taking safinamide and each||
1836|027|H|time you get a refill. If you have any questions, ask your doctor||
1836|028|H|or pharmacist.||
1836|029|H|   Take this medication by mouth with or without food as directed||
1836|030|H|by your doctor, usually once daily.||
1836|031|H|   The dosage is based on your medical condition and response to||
1836|032|H|treatment. Do not increase your dose or take it more often than||
1836|033|H|prescribed. Your condition will not improve any faster, and your||
1836|034|H|risk of side effects will increase.||
1836|035|H|   Use this medication regularly to get the most benefit from it.||
1836|036|H|To help you remember, take it at the same time each day.||
1836|037|H|   Do not stop taking this medication without consulting your||
1836|038|H|doctor. Some conditions may become worse when this drug is||
1836|039|H|suddenly stopped. Your dose may need to be gradually decreased.||
1836|040|H|   A very serious high blood pressure reaction may rarely occur||
1836|041|H|if you eat a large amount of tyramine while taking safinamide and||
1836|042|H|for 2 weeks after you stop it. Avoid foods that are high in||
1836|043|H|tyramine, like aged cheeses (such as Stilton cheese). Consult||
1836|044|H|your doctor or dietician about which foods you should avoid and||
1836|045|H|if you do not feel well after eating or drinking certain foods||
1836|046|H|while taking this medication. See also Side Effects section.||
1836|047|H|   Tell your doctor if this medication stops working well or if||
1836|048|H|your condition gets worse.||
1836|049|B|||
1836|050|S|SIDE EFFECTS:  Dizziness or drowsiness may occur. If either of||
1836|051|S|these effects lasts or gets worse, tell your doctor or pharmacist||
1836|052|S|promptly.||
1836|053|S|   To reduce the risk of dizziness and lightheadedness, get up||
1836|054|S|slowly when rising from a sitting or lying position, especially||
1836|055|S|when you first start taking safinamide.||
1836|056|S|   Remember that this medication has been prescribed because your||
1836|057|S|doctor has judged that the benefit to you is greater than the||
1836|058|S|risk of side effects. Many people using this medication do not||
1836|059|S|have serious side effects.||
1836|060|S|   Tell your doctor right away if you have any serious side||
1836|061|S|effects, including: fainting, loss of balance, mental/mood||
1836|062|S|changes (such as anxiety, agitation, hallucinations), worsening||
1836|063|S|muscle stiffness/twitching/uncontrollable movements, unusual||
1836|064|S|strong urges (such as increased gambling, increased sexual||
1836|065|S|urges).||
1836|066|S|   Some people taking safinamide have fallen asleep suddenly||
1836|067|S|during their usual daily activities (such as talking on the||
1836|068|S|phone, driving). In some cases, sleep occurred without any||
1836|069|S|feelings of drowsiness beforehand. This sleep effect may occur||
1836|070|S|anytime during treatment with safinamide even if you have used||
1836|071|S|this medication for a long time. If you experience increased||
1836|072|S|sleepiness or fall asleep during the day, do not drive or take||
1836|073|S|part in other possibly dangerous activities until you have||
1836|074|S|discussed this effect with your doctor. Your risk of this sleep||
1836|075|S|effect is increased by using alcohol or other medications that||
1836|076|S|can make you drowsy. See also Precautions section.||
1836|077|S|   This medication may increase serotonin and rarely cause a very||
1836|078|S|serious condition called serotonin syndrome/toxicity. The risk||
1836|079|S|increases if you are also taking other drugs that increase||
1836|080|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1836|081|S|take. Get medical help right away if you develop some of the||
1836|082|S|following symptoms: fast heartbeat, hallucinations, loss of||
1836|083|S|coordination, severe dizziness, severe nausea/vomiting/diarrhea,||
1836|084|S|twitching muscles, unexplained fever, unusual||
1836|085|S|agitation/restlessness.||
1836|086|S|   This drug may rarely cause an attack of extremely high blood||
1836|087|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
1836|088|S|food interactions can increase this risk (see How to Use and Drug||
1836|089|S|Interactions sections). Get medical help right away if any of||
1836|090|S|these serious side effects occur: severe headache,||
1836|091|S|fast/slow/irregular/pounding heartbeat, chest pain, neck||
1836|092|S|stiffness/soreness, severe nausea/vomiting, sweating/clammy skin||
1836|093|S|(sometimes with fever), widened pupils, vision changes (such as||
1836|094|S|double/blurred vision), sudden sensitivity to light||
1836|095|S|(photophobia).||
1836|096|S|   A very serious allergic reaction to this drug is rare.||
1836|097|S|However, get medical help right away if you notice any symptoms||
1836|098|S|of a serious allergic reaction, including: rash, itching/swelling||
1836|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1836|100|S|breathing.||
1836|101|S|   This is not a complete list of possible side effects. If you||
1836|102|S|notice other effects not listed above, contact your doctor or||
1836|103|S|pharmacist.||
1836|104|S|   In the US -||
1836|105|S|   Call your doctor for medical advice about side effects. You||
1836|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1836|107|S|www.fda.gov/medwatch.||
1836|108|S|   In Canada - Call your doctor for medical advice about side||
1836|109|S|effects. You may report side effects to Health Canada at||
1836|110|S|1-866-234-2345.||
1836|111|B|||
1836|112|P|PRECAUTIONS:  Before taking safinamide, tell your doctor or||
1836|113|P|pharmacist if you are allergic to it; or if you have any other||
1836|114|P|allergies. This product may contain inactive ingredients, which||
1836|115|P|can cause allergic reactions or other problems. Talk to your||
1836|116|P|pharmacist for more details.||
1836|117|P|   Before using this medication, tell your doctor or pharmacist||
1836|118|P|your medical history, especially of: liver disease, high blood||
1836|119|P|pressure, mental/mood disorders (such as schizophrenia, bipolar||
1836|120|P|disorder, depression), eye problems (such as macular||
1836|121|P|degeneration, uveitis), sleep disorders.||
1836|122|P|   This drug may make you drowsy or dizzy. Alcohol or marijuana||
1836|123|P|(cannabis) can make you more drowsy or dizzy. Do not drive, use||
1836|124|P|machinery, or do anything that needs alertness until you can do||
1836|125|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1836|126|P|are using marijuana (cannabis). See also Side Effects section.||
1836|127|P|   Before having surgery, tell your doctor or dentist about all||
1836|128|P|the products you use (including prescription drugs,||
1836|129|P|nonprescription drugs, and herbal products).||
1836|130|P|   During pregnancy, this medication should be used only when||
1836|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
1836|132|P|   It is unknown if this drug passes into breast milk. Consult||
1836|133|P|your doctor before breastfeeding.||
1836|134|B|||
1836|135|I|DRUG INTERACTIONS:  See also How to Use section.||
1836|136|I|   Drug interactions may change how your medications work or||
1836|137|I|increase your risk for serious side effects. This document does||
1836|138|I|not contain all possible drug interactions. Keep a list of all||
1836|139|I|the products you use (including prescription/nonprescription||
1836|140|I|drugs and herbal products) and share it with your doctor and||
1836|141|I|pharmacist. Do not start, stop, or change the dosage of any||
1836|142|I|medicines without your doctor's approval.||
1836|143|I|   Some products that may interact with this drug are:||
1836|144|I|apraclonidine, bupropion, buspirone, carbamazepine, diet||
1836|145|I|pills/appetite suppressants (such as diethylpropion),||
1836|146|I|deutetrabenazine, dextromethorphan, methyldopa, metoclopramide,||
1836|147|I|certain supplements (such as tryptophan, tyramine),||
1836|148|I|tetrabenazine, certain "triptans" used to treat migraine||
1836|149|I|headaches (such as rizatriptan, sumatriptan, zolmitriptan),||
1836|150|I|valbenazine.||
1836|151|I|   The risk of serotonin syndrome/toxicity increases if you are||
1836|152|I|also taking other drugs that increase serotonin. Examples include||
1836|153|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1836|154|I|antidepressants (including trazodone, SSRIs such as||
1836|155|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine,||
1836|156|I|tricyclics such as amitriptyline/doxepin), drugs for attention||
1836|157|I|deficit disorder (such as amphetamine, methylphenidate),||
1836|158|I|cyclobenzaprine, certain opioid medications (such as meperidine,||
1836|159|I|methadone, propoxyphene, tramadol), among others. The risk of||
1836|160|I|serotonin syndrome/toxicity may be more likely when you start or||
1836|161|I|increase the dose of these drugs.||
1836|162|I|   Some products can interact with safinamide if you take them||
1836|163|I|together, or even if you take them weeks before or after taking||
1836|164|I|safinamide. Tell your doctor or pharmacist if you take anything||
1836|165|I|in the list of products that may interact with this drug, or any||
1836|166|I|of the products that increase serotonin, within 2 weeks before or||
1836|167|I|after taking safinamide. Also tell them if you have taken||
1836|168|I|fluoxetine within 5 weeks before starting safinamide. Ask your||
1836|169|I|doctor how much time to wait between starting or stopping any of||
1836|170|I|these drugs and starting safinamide.||
1836|171|I|   Taking other MAO inhibitors with this medication may cause a||
1836|172|I|serious (possibly fatal) drug interaction. Do not take any other||
1836|173|I|MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene||
1836|174|I|blue, moclobemide, phenelzine, procarbazine, rasagiline,||
1836|175|I|selegiline, tranylcypromine) during treatment with this||
1836|176|I|medication. Most MAO inhibitors should also not be taken for two||
1836|177|I|weeks before and after treatment with this medication. Ask your||
1836|178|I|doctor when to start or stop taking this medication.||
1836|179|I|   Before using safinamide, report the use of drugs that may||
1836|180|I|increase the risk of extremely high blood pressure (hypertensive||
1836|181|I|crisis) when combined with safinamide, including herbal products||
1836|182|I|(such as ephedra/ma Huang), allergy and cough-and-cold products||
1836|183|I|(including decongestants such as phenylephrine/pseudoephedrine),||
1836|184|I|and stimulants (such as amphetamines, ephedrine, epinephrine,||
1836|185|I|phenylalanine). Talk to your doctor or pharmacist for more||
1836|186|I|details.||
1836|187|I|   Tell your doctor or pharmacist if you are taking other||
1836|188|I|products that cause drowsiness such as opioid pain or cough||
1836|189|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1836|190|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1836|191|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol), or||
1836|192|I|antihistamines (such as cetirizine, diphenhydramine).||
1836|193|B|||
1836|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1836|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1836|196|O|poison control center right away. US residents can call||
1836|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1836|198|B|||
1836|199|N|NOTES:  Do not share this medication with others.||
1836|200|N|   Lab and/or medical tests (such as blood pressure, liver||
1836|201|N|function) should be done while you are taking this medication.||
1836|202|N|Keep all medical and lab appointments.||
1836|203|B|||
1836|204|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1836|205|D|next dose at the regular time. Do not double the dose to catch||
1836|206|D|up.||
1836|207|B|||
1836|208|R|STORAGE:  Store at room temperature away from light and moisture.||
1836|209|R|Do not store in the bathroom. Keep all medications away from||
1836|210|R|children and pets.||
1836|211|R|   Do not flush medications down the toilet or pour them into a||
1836|212|R|drain unless instructed to do so. Properly discard this product||
1836|213|R|when it is expired or no longer needed. Consult your pharmacist||
1836|214|R|or local waste disposal company.||
1836|215|B|||
1836|216|A|Information last revised May 2024.||
1836|217|A|Copyright(c) 2025 First Databank, Inc.||
1836|218|B|||
1837|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1837|002|Z|does NOT have all possible information about this product. This||
1837|003|Z|information does not assure that this product is safe, effective,||
1837|004|Z|or appropriate for you. This information is not individual||
1837|005|Z|medical advice and does not substitute for the advice of your||
1837|006|Z|health care professional. Always ask your health care||
1837|007|Z|professional for complete information about this product and your||
1837|008|Z|specific health needs.||
1837|009|B|||
1837|010|T|EDARAVONE - INJECTION||
1837|011|F|(e-DAR-a-vone)||
1837|012|B|||
1837|013|C|COMMON BRAND NAME(S): Radicava||
1837|014|B|||
1837|015|U|USES:  Edaravone is used to treat a certain type of nerve disease||
1837|016|U|called amyotrophic lateral sclerosis (ALS, also commonly called||
1837|017|U|Lou Gehrig's disease). It helps to slow down the worsening of||
1837|018|U|this disease. However, it is not a cure for ALS, and it does not||
1837|019|U|reverse nerve damage or muscle weakness.||
1837|020|B|||
1837|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1837|022|H|from your pharmacist before you start using edaravone and with||
1837|023|H|each treatment cycle. If you have any questions, ask your doctor||
1837|024|H|or pharmacist.||
1837|025|H|   This medication is given by injection into a vein as directed||
1837|026|H|by your doctor, usually over 1 hour. For the first treatment||
1837|027|H|cycle, this medication is usually given once daily for 14 days,||
1837|028|H|followed by no edaravone for 14 days. After that, each treatment||
1837|029|H|cycle is usually scheduled as edaravone given once daily for 10||
1837|030|H|days out of a 14-day period, followed by no edaravone for 14||
1837|031|H|days.||
1837|032|H|   If you are using this medication at home, learn all||
1837|033|H|preparation and usage instructions from your health care||
1837|034|H|professional. Before using, check this product for particles or||
1837|035|H|discoloration. If either is present, do not use the liquid. Learn||
1837|036|H|how to store and discard medical supplies safely.||
1837|037|H|   Use this medication regularly to get the most benefit from it.||
1837|038|H|To help you remember, mark your calendar with a reminder.||
1837|039|B|||
1837|040|S|SIDE EFFECTS:  Bruising, problems walking, or headache may occur.||
1837|041|S|If any of these effects last or get worse, tell your doctor or||
1837|042|S|pharmacist promptly.||
1837|043|S|   Remember that this medication has been prescribed because your||
1837|044|S|doctor has judged that the benefit to you is greater than the||
1837|045|S|risk of side effects. Many people using this medication do not||
1837|046|S|have serious side effects.||
1837|047|S|   A very serious allergic reaction to this drug is rare.||
1837|048|S|However, get medical help right away if you notice any symptoms||
1837|049|S|of a serious allergic reaction, including: rash, itching/swelling||
1837|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1837|051|S|breathing.||
1837|052|S|   This is not a complete list of possible side effects. If you||
1837|053|S|notice other effects not listed above, contact your doctor or||
1837|054|S|pharmacist.||
1837|055|S|   In the US -||
1837|056|S|   Call your doctor for medical advice about side effects. You||
1837|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1837|058|S|www.fda.gov/medwatch.||
1837|059|S|   In Canada - Call your doctor for medical advice about side||
1837|060|S|effects. You may report side effects to Health Canada at||
1837|061|S|1-866-234-2345.||
1837|062|B|||
1837|063|P|PRECAUTIONS:  Before using edaravone, tell your doctor or||
1837|064|P|pharmacist if you are allergic to it; or if you have any other||
1837|065|P|allergies. This product may contain inactive ingredients||
1837|066|P|(including sulfites such as sodium bisulfite), which can cause||
1837|067|P|allergic reactions or other problems. Talk to your pharmacist for||
1837|068|P|more details.||
1837|069|P|   Before using this medication, tell your doctor or pharmacist||
1837|070|P|your medical history, especially of: asthma.||
1837|071|P|   Before having surgery, tell your doctor or dentist about all||
1837|072|P|the products you use (including prescription drugs,||
1837|073|P|nonprescription drugs, and herbal products).||
1837|074|P|   During pregnancy, this medication should be used only when||
1837|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
1837|076|P|   It is unknown if this medication passes into breast milk.||
1837|077|P|Consult your doctor before breastfeeding.||
1837|078|B|||
1837|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1837|080|I|medications work or increase your risk for serious side effects.||
1837|081|I|This document does not contain all possible drug interactions.||
1837|082|I|Keep a list of all the products you use (including||
1837|083|I|prescription/nonprescription drugs and herbal products) and share||
1837|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
1837|085|I|the dosage of any medicines without your doctor's approval.||
1837|086|B|||
1837|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1837|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1837|089|O|poison control center right away. US residents can call||
1837|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1837|091|B|||
1837|092|N|NOTES:  Lab and/or medical tests may be done while you are using||
1837|093|N|this medication. Keep all medical and lab appointments.||
1837|094|B|||
1837|095|D|MISSED DOSE:  It is important to get each dose of this medication||
1837|096|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1837|097|D|right away for a new dosing schedule.||
1837|098|B|||
1837|099|R|STORAGE:  Store at room temperature away from light. If your||
1837|100|R|product comes in a bag, keep the product in the overwrap package||
1837|101|R|until ready to use. Once the overwrap package is opened, this||
1837|102|R|medication expires after 24 hours. Keep all medications away from||
1837|103|R|children and pets.||
1837|104|R|   Do not flush medications down the toilet or pour them into a||
1837|105|R|drain unless instructed to do so. Properly discard this product||
1837|106|R|when it is expired or no longer needed. Consult your pharmacist||
1837|107|R|or local waste disposal company.||
1837|108|B|||
1837|109|A|Information last revised November 2024.||
1837|110|A|Copyright(c) 2025 First Databank, Inc.||
1837|111|B|||
1838|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1838|002|Z|does NOT have all possible information about this product. This||
1838|003|Z|information does not assure that this product is safe, effective,||
1838|004|Z|or appropriate for you. This information is not individual||
1838|005|Z|medical advice and does not substitute for the advice of your||
1838|006|Z|health care professional. Always ask your health care||
1838|007|Z|professional for complete information about this product and your||
1838|008|Z|specific health needs.||
1838|009|B|||
1838|010|T|DICHLORPHENAMIDE - ORAL||
1838|011|F|(DYE-klor-FEN-a-mide)||
1838|012|B|||
1838|013|C|COMMON BRAND NAME(S): Keveyis||
1838|014|B|||
1838|015|U|USES:  This medication is used to treat a certain inherited||
1838|016|U|condition that causes attacks of muscle weakness or loss of||
1838|017|U|muscle movement that come and go (primary periodic paralysis).||
1838|018|U|Dichlorphenamide belongs to a class of drugs known as carbonic||
1838|019|U|anhydrase inhibitors. It is not known how it works for this||
1838|020|U|condition, but it can decrease the number of attacks of muscle||
1838|021|U|weakness.||
1838|022|B|||
1838|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
1838|024|H|doctor, usually once or twice daily. The dosage is based on your||
1838|025|H|medical condition and response to treatment.||
1838|026|H|   Use this medication regularly to get the most benefit from it.||
1838|027|H|To help you remember, take it at the same time(s) each day.||
1838|028|H|   Tell your doctor if your condition does not get better or if||
1838|029|H|it gets worse.||
1838|030|B|||
1838|031|S|SIDE EFFECTS:  Numbness/tingling, change in the sense of taste,||
1838|032|S|nausea, diarrhea, weight loss, muscle spasms/twitching,||
1838|033|S|tiredness, dizziness, or drowsiness may occur. If any of these||
1838|034|S|effects last or get worse, tell your doctor or pharmacist||
1838|035|S|promptly.||
1838|036|S|   Dizziness can increase the risk of falling. Get up slowly when||
1838|037|S|rising from a sitting or lying position.||
1838|038|S|   Remember that this medication has been prescribed because your||
1838|039|S|doctor has judged that the benefit to you is greater than the||
1838|040|S|risk of side effects. Many people using this medication do not||
1838|041|S|have serious side effects.||
1838|042|S|   Tell your doctor right away if you have any serious side||
1838|043|S|effects, including: easy bleeding/bruising, rapid breathing,||
1838|044|S|unusual tiredness, mental/mood changes (such as confusion,||
1838|045|S|inability to think clearly), signs of low potassium level in the||
1838|046|S|blood (such as muscle cramps, irregular heartbeat).||
1838|047|S|   A very serious allergic reaction to this drug is rare.||
1838|048|S|However, get medical help right away if you notice any symptoms||
1838|049|S|of a serious allergic reaction, including: rash, itching/swelling||
1838|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1838|051|S|breathing.||
1838|052|S|   This is not a complete list of possible side effects. If you||
1838|053|S|notice other effects not listed above, contact your doctor or||
1838|054|S|pharmacist.||
1838|055|S|   In the US -||
1838|056|S|   Call your doctor for medical advice about side effects. You||
1838|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1838|058|S|www.fda.gov/medwatch.||
1838|059|S|   In Canada - Call your doctor for medical advice about side||
1838|060|S|effects. You may report side effects to Health Canada at||
1838|061|S|1-866-234-2345.||
1838|062|B|||
1838|063|P|PRECAUTIONS:  Before taking dichlorphenamide, tell your doctor or||
1838|064|P|pharmacist if you are allergic to it; or if you have any other||
1838|065|P|allergies. This product may contain inactive ingredients, which||
1838|066|P|can cause allergic reactions or other problems. Talk to your||
1838|067|P|pharmacist for more details.||
1838|068|P|   Before using this medication, tell your doctor or pharmacist||
1838|069|P|your medical history, especially of: adrenal gland problems (such||
1838|070|P|as Addison's disease), liver problems, breathing problems (such||
1838|071|P|as asthma, chronic obstructive lung disease-COPD).||
1838|072|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1838|073|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1838|074|P|machinery, or do anything that needs alertness until you can do||
1838|075|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1838|076|P|are using marijuana (cannabis).||
1838|077|P|   This medication may make you more sensitive to the sun. Limit||
1838|078|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1838|079|P|sunscreen and wear protective clothing when outdoors. Tell your||
1838|080|P|doctor right away if you get sunburned or have skin||
1838|081|P|blisters/redness.||
1838|082|P|   Before having surgery, tell your doctor or dentist about all||
1838|083|P|the products you use (including prescription drugs,||
1838|084|P|nonprescription drugs, and herbal products).||
1838|085|P|   Older adults may be at greater risk for falls or low||
1838|086|P|bicarbonate levels while using this drug.||
1838|087|P|   During pregnancy, this medication should be used only when||
1838|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
1838|089|P|   It is unknown if this medication passes into breast milk.||
1838|090|P|Consult your doctor before breastfeeding.||
1838|091|B|||
1838|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1838|093|I|medications work or increase your risk for serious side effects.||
1838|094|I|This document does not contain all possible drug interactions.||
1838|095|I|Keep a list of all the products you use (including||
1838|096|I|prescription/nonprescription drugs and herbal products) and share||
1838|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
1838|098|I|the dosage of any medicines without your doctor's approval.||
1838|099|I|   Some products that may interact with this drug are: aspirin||
1838|100|I|(in high doses used to treat pain), salicylates, methenamine.||
1838|101|I|   If your doctor has told you to take low-dose aspirin to||
1838|102|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
1838|103|I|you should keep taking the aspirin unless your doctor tells you||
1838|104|I|not to.||
1838|105|B|||
1838|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1838|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1838|108|O|poison control center right away. US residents can call||
1838|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1838|110|O|Symptoms of overdose may include: shaking (tremors), ringing in||
1838|111|O|the ears.||
1838|112|B|||
1838|113|N|NOTES:  Do not share this medication with others.||
1838|114|N|   Lab and/or medical tests (such as bicarbonate and potassium||
1838|115|N|blood levels) should be done before you start taking this||
1838|116|N|medication and while you are taking it. Keep all medical and lab||
1838|117|N|appointments.||
1838|118|B|||
1838|119|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1838|120|D|remember. If it is near the time of the next dose, skip the||
1838|121|D|missed dose. Take your next dose at the regular time. Do not||
1838|122|D|double the dose to catch up.||
1838|123|B|||
1838|124|R|STORAGE:  Store at room temperature away from light and moisture.||
1838|125|R|Do not store in the bathroom. Keep all medications away from||
1838|126|R|children and pets.||
1838|127|R|   Do not flush medications down the toilet or pour them into a||
1838|128|R|drain unless instructed to do so. Properly discard this product||
1838|129|R|when it is expired or no longer needed. Consult your pharmacist||
1838|130|R|or local waste disposal company.||
1838|131|B|||
1838|132|A|Information last revised May 2024.||
1838|133|A|Copyright(c) 2025 First Databank, Inc.||
1838|134|B|||
1839|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1839|002|Z|does NOT have all possible information about this product. This||
1839|003|Z|information does not assure that this product is safe, effective,||
1839|004|Z|or appropriate for you. This information is not individual||
1839|005|Z|medical advice and does not substitute for the advice of your||
1839|006|Z|health care professional. Always ask your health care||
1839|007|Z|professional for complete information about this product and your||
1839|008|Z|specific health needs.||
1839|009|B|||
1839|010|T|PRASTERONE INSERT - VAGINAL||
1839|011|F|(PRAS-ter-one)||
1839|012|B|||
1839|013|C|COMMON BRAND NAME(S): Intrarosa||
1839|014|B|||
1839|015|U|USES:  This medication is used by women after menopause to treat||
1839|016|U|painful sexual intercourse. Painful intercourse can be a symptom||
1839|017|U|of changes in and around your vagina, due to menopause.||
1839|018|U|Prasterone belongs to a class of drugs known as steroids. It is||
1839|019|U|not well understood how it works to lessen painful intercourse,||
1839|020|U|but prasterone is changed in the body to certain hormones||
1839|021|U|(androgens and estrogens).||
1839|022|B|||
1839|023|H|HOW TO USE:  Read the Patient Information Leaflet and||
1839|024|H|Instructions for Use if available from your pharmacist before you||
1839|025|H|start using prasterone and each time you get a refill. If you||
1839|026|H|have any questions, ask your doctor or pharmacist.||
1839|027|H|   This medication is for vaginal use only. Empty your bladder||
1839|028|H|and wash your hands before handling the vaginal insert and||
1839|029|H|applicator. Unwrap one vaginal insert and follow the instructions||
1839|030|H|to use the applicator to insert this medication into the vagina||
1839|031|H|as directed by your doctor, usually once daily at bedtime.||
1839|032|H|   Use this medication regularly to get the most benefit from it.||
1839|033|H|To help you remember, use it at the same time each day.||
1839|034|H|   Tell your doctor if your condition does not get better or if||
1839|035|H|it gets worse.||
1839|036|B|||
1839|037|S|SIDE EFFECTS:  Vaginal discharge may occur. If this effect lasts||
1839|038|S|or gets worse, tell your doctor or pharmacist promptly.||
1839|039|S|   Remember that this medication has been prescribed because your||
1839|040|S|doctor has judged that the benefit to you is greater than the||
1839|041|S|risk of side effects. Many people using this medication do not||
1839|042|S|have serious side effects.||
1839|043|S|   You may have an abnormal Pap smear test result after using||
1839|044|S|this medication. Your doctor will monitor your results and tell||
1839|045|S|you if more tests are needed.||
1839|046|S|   A very serious allergic reaction to this drug is rare.||
1839|047|S|However, get medical help right away if you notice any symptoms||
1839|048|S|of a serious allergic reaction, including: rash, itching/swelling||
1839|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1839|050|S|breathing.||
1839|051|S|   This is not a complete list of possible side effects. If you||
1839|052|S|notice other effects not listed above, contact your doctor or||
1839|053|S|pharmacist.||
1839|054|S|   In the US -||
1839|055|S|   Call your doctor for medical advice about side effects. You||
1839|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1839|057|S|www.fda.gov/medwatch.||
1839|058|S|   In Canada - Call your doctor for medical advice about side||
1839|059|S|effects. You may report side effects to Health Canada at||
1839|060|S|1-866-234-2345.||
1839|061|B|||
1839|062|P|PRECAUTIONS:  Before using prasterone, tell your doctor or||
1839|063|P|pharmacist if you are allergic to it; or if you have any other||
1839|064|P|allergies. This product may contain inactive ingredients, which||
1839|065|P|can cause allergic reactions or other problems. Talk to your||
1839|066|P|pharmacist for more details.||
1839|067|P|   Before using this medication, tell your doctor or pharmacist||
1839|068|P|your medical history, especially of: breast cancer, vaginal||
1839|069|P|bleeding.||
1839|070|P|   Before having surgery, tell your doctor or dentist about all||
1839|071|P|the products you use (including prescription drugs,||
1839|072|P|nonprescription drugs, and herbal products).||
1839|073|P|   This medication is not usually used by women of childbearing||
1839|074|P|age. Tell your doctor if you are planning pregnancy, become||
1839|075|P|pregnant, or think you may be pregnant.||
1839|076|P|   It is unknown if this medication passes into breast milk.||
1839|077|P|Consult your doctor before breastfeeding.||
1839|078|B|||
1839|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1839|080|I|medications work or increase your risk for serious side effects.||
1839|081|I|This document does not contain all possible drug interactions.||
1839|082|I|Keep a list of all the products you use (including||
1839|083|I|prescription/nonprescription drugs and herbal products) and share||
1839|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
1839|085|I|the dosage of any medicines without your doctor's approval.||
1839|086|B|||
1839|087|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1839|088|O|has overdosed and has serious symptoms such as passing out or||
1839|089|O|trouble breathing, call 911. Otherwise, call a poison control||
1839|090|O|center right away. US residents can call 1-800-222-1222. Canada||
1839|091|O|residents can call 1-844-764-7669.||
1839|092|B|||
1839|093|N|NOTES:  Do not share this medication with others.||
1839|094|N|   Lab and/or medical tests (such as Pap smear) may be done while||
1839|095|N|you are using this medication. Keep all medical and lab||
1839|096|N|appointments.||
1839|097|B|||
1839|098|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1839|099|D|If it is near the time of the next dose, skip the missed dose.||
1839|100|D|Use your next dose at the regular time. Do not double the dose to||
1839|101|D|catch up.||
1839|102|B|||
1839|103|R|STORAGE:  Store in the refrigerator or at room temperature away||
1839|104|R|from light. Do not freeze. Keep all medications away from||
1839|105|R|children and pets.||
1839|106|R|   Do not flush medications down the toilet or pour them into a||
1839|107|R|drain unless instructed to do so. Properly discard this product||
1839|108|R|when it is expired or no longer needed. Consult your pharmacist||
1839|109|R|or local waste disposal company.||
1839|110|B|||
1839|111|A|Information last revised January 2025.||
1839|112|A|Copyright(c) 2025 First Databank, Inc.||
1839|113|B|||
1840|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1840|002|Z|does NOT have all possible information about this product. This||
1840|003|Z|information does not assure that this product is safe, effective,||
1840|004|Z|or appropriate for you. This information is not individual||
1840|005|Z|medical advice and does not substitute for the advice of your||
1840|006|Z|health care professional. Always ask your health care||
1840|007|Z|professional for complete information about this product and your||
1840|008|Z|specific health needs.||
1840|009|B|||
1840|010|T|DRONABINOL SOLUTION - ORAL||
1840|011|F|(droe-NAB-i-nol)||
1840|012|B|||
1840|013|C|COMMON BRAND NAME(S): Syndros||
1840|014|B|||
1840|015|U|USES:  Dronabinol is used to treat nausea and vomiting caused by||
1840|016|U|cancer chemotherapy. It is used when other drugs usually used to||
1840|017|U|control nausea and vomiting have not worked well. Dronabinol is||
1840|018|U|also used to treat loss of appetite and weight loss in people||
1840|019|U|with HIV infection. Dronabinol (also called THC) is a man-made||
1840|020|U|form of a natural substance in marijuana (cannabis).||
1840|021|B|||
1840|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
1840|023|H|Instructions for Use if available from your pharmacist before you||
1840|024|H|start taking dronabinol and each time you get a refill. If you||
1840|025|H|have any questions, ask your doctor or pharmacist.||
1840|026|H|   Take this medication by mouth as directed by your doctor,||
1840|027|H|usually up to 4 to 6 times daily if you are taking it to control||
1840|028|H|nausea and vomiting, or twice daily (1 hour before lunch and 1||
1840|029|H|hour before dinner) if you are taking it to treat loss of||
1840|030|H|appetite. Drink a full glass of water (8 ounces/240 milliliters)||
1840|031|H|right after taking each dose. Follow your doctor's instructions||
1840|032|H|carefully.||
1840|033|H|   Carefully measure the dose using a special measuring||
1840|034|H|device/spoon. Do not use a household spoon because you may not||
1840|035|H|get the correct dose.||
1840|036|H|   The dosage is based on your medical condition and response to||
1840|037|H|treatment. If you are taking this medication to control nausea||
1840|038|H|and vomiting, your dosage may also be based on your body size.||
1840|039|H|   Do not increase your dose or use this drug more often or for||
1840|040|H|longer than prescribed. Your condition will not improve any||
1840|041|H|faster, and your risk of serious side effects will increase.||
1840|042|H|   If you suddenly stop using this medication, you may have||
1840|043|H|withdrawal symptoms (such as irritability, trouble sleeping,||
1840|044|H|restlessness, hot flashes, diarrhea). To help prevent withdrawal,||
1840|045|H|your doctor may lower your dose slowly. Withdrawal is more likely||
1840|046|H|if you have used dronabinol for a long time or in high doses.||
1840|047|H|Tell your doctor or pharmacist right away if you have withdrawal.||
1840|048|H|   Though it helps many people, this medication may sometimes||
1840|049|H|cause addiction. This risk may be higher if you have a substance||
1840|050|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1840|051|H|Take this medication exactly as prescribed to lower the risk of||
1840|052|H|addiction. Ask your doctor or pharmacist for more details.||
1840|053|H|   Tell your doctor if your condition does not get better or if||
1840|054|H|it gets worse.||
1840|055|B|||
1840|056|S|SIDE EFFECTS:  Dizziness, drowsiness, confusion, feeling "high,"||
1840|057|S|an exaggerated sense of well-being, lightheadedness, nausea,||
1840|058|S|vomiting, or stomach/abdominal pain may occur as your body||
1840|059|S|adjusts to the medication. If any of these effects last or get||
1840|060|S|worse, tell your doctor or pharmacist promptly.||
1840|061|S|   To reduce the risk of dizziness and lightheadedness, get up||
1840|062|S|slowly when rising from a sitting or lying position.||
1840|063|S|   Remember that this medication has been prescribed because your||
1840|064|S|doctor has judged that the benefit to you is greater than the||
1840|065|S|risk of side effects. Many people using this medication do not||
1840|066|S|have serious side effects.||
1840|067|S|   Tell your doctor right away if you have any serious side||
1840|068|S|effects, including: fainting, fast/pounding heartbeat,||
1840|069|S|mental/mood changes (such as anxiety, nervousness,||
1840|070|S|hallucinations, abnormal thoughts, paranoia).||
1840|071|S|   A very serious allergic reaction to this drug is rare.||
1840|072|S|However, get medical help right away if you notice any symptoms||
1840|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1840|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1840|075|S|breathing.||
1840|076|S|   This is not a complete list of possible side effects. If you||
1840|077|S|notice other effects not listed above, contact your doctor or||
1840|078|S|pharmacist.||
1840|079|S|   In the US -||
1840|080|S|   Call your doctor for medical advice about side effects. You||
1840|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1840|082|S|www.fda.gov/medwatch.||
1840|083|S|   In Canada - Call your doctor for medical advice about side||
1840|084|S|effects. You may report side effects to Health Canada at||
1840|085|S|1-866-234-2345.||
1840|086|B|||
1840|087|P|PRECAUTIONS:  Before taking dronabinol, tell your doctor or||
1840|088|P|pharmacist if you are allergic to it; or to marijuana (cannabis);||
1840|089|P|or if you have any other allergies. This product may contain||
1840|090|P|inactive ingredients (such as alcohol), which can cause allergic||
1840|091|P|reactions or other problems. Talk to your pharmacist for more||
1840|092|P|details.||
1840|093|P|   Before using this medication, tell your doctor or pharmacist||
1840|094|P|your medical history, especially of: personal or family history||
1840|095|P|of a substance use disorder (such as overuse of or addiction to||
1840|096|P|drugs/alcohol), heart disease, high blood pressure, mental/mood||
1840|097|P|disorders (such as mania, depression, schizophrenia), seizures.||
1840|098|P|   This drug may make you dizzy or drowsy or may affect your||
1840|099|P|judgment. Alcohol or marijuana (cannabis) can worsen these||
1840|100|P|effects. Do not drive, use machinery, or do anything that needs||
1840|101|P|alertness until you can do it safely. Avoid alcoholic beverages.||
1840|102|P|Talk to your doctor if you are using marijuana (cannabis).||
1840|103|P|   Before having surgery, tell your doctor or dentist about all||
1840|104|P|the products you use (including prescription drugs,||
1840|105|P|nonprescription drugs, and herbal products).||
1840|106|P|   Children may be more sensitive to the side effects of this||
1840|107|P|drug, especially drowsiness and mental/mood changes.||
1840|108|P|   Older adults may be more sensitive to the side effects of this||
1840|109|P|drug, especially drowsiness, dizziness, lightheadedness, and||
1840|110|P|mental/mood changes.||
1840|111|P|   Tell your doctor if you are pregnant or plan to become||
1840|112|P|pregnant. You should not become pregnant while using dronabinol.||
1840|113|P|Dronabinol may harm an unborn baby. If you become pregnant, talk||
1840|114|P|to your doctor right away about the risks and benefits of this||
1840|115|P|medication.||
1840|116|P|   This medication passes into breast milk and may harm a nursing||
1840|117|P|infant. Breastfeeding is not recommended while using this||
1840|118|P|medication. Consult your doctor before breastfeeding.||
1840|119|B|||
1840|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1840|121|I|medications work or increase your risk for serious side effects.||
1840|122|I|This document does not contain all possible drug interactions.||
1840|123|I|Keep a list of all the products you use (including||
1840|124|I|prescription/nonprescription drugs and herbal products) and share||
1840|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1840|126|I|the dosage of any medicines without your doctor's approval.||
1840|127|I|   Dronabinol solution contains alcohol. Certain medications||
1840|128|I|(such as disulfiram, metronidazole) should not be taken within 2||
1840|129|I|weeks before, during, or 7 days after taking dronabinol solution.||
1840|130|I|Doing so can lead to a reaction that may include flushing,||
1840|131|I|throbbing headache, breathing problems (such as shortness of||
1840|132|I|breath, fast breathing), nausea, vomiting, dizziness, extreme||
1840|133|I|tiredness, fainting, fast/irregular heartbeat, or blurred vision.||
1840|134|I|Consult your doctor or pharmacist for details.||
1840|135|I|   Tell your doctor or pharmacist if you are taking other||
1840|136|I|products that cause drowsiness such as opioid pain or cough||
1840|137|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1840|138|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1840|139|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1840|140|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1840|141|I|diphenhydramine).||
1840|142|I|   Check the labels on all your medicines (such as allergy or||
1840|143|I|cough-and-cold products) because they may contain ingredients||
1840|144|I|that cause drowsiness. Ask your pharmacist about using those||
1840|145|I|products safely.||
1840|146|B|||
1840|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1840|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1840|149|O|poison control center right away. US residents can call||
1840|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1840|151|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
1840|152|O|fast heartbeat, mental/mood changes, seizures.||
1840|153|B|||
1840|154|N|NOTES:  Do not share this medication with others. Sharing it is||
1840|155|N|against the law.||
1840|156|N|   Keep this medication in a safe place to prevent theft, misuse,||
1840|157|N|or abuse.||
1840|158|N|   Keep all medical and lab appointments.||
1840|159|B|||
1840|160|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1840|161|D|remember. If it is near the time of the next dose, skip the||
1840|162|D|missed dose. Take your next dose at the regular time. Do not||
1840|163|D|double the dose to catch up.||
1840|164|B|||
1840|165|R|STORAGE:  Store the unopened bottle in the refrigerator. Store||
1840|166|R|the opened bottle in the refrigerator or at room temperature.||
1840|167|R|Once the bottle is opened, this medication expires after 42 days.||
1840|168|R|Keep all medications away from children and pets.||
1840|169|R|   Do not flush medications down the toilet or pour them into a||
1840|170|R|drain unless instructed to do so. Properly discard this product||
1840|171|R|when it is expired or no longer needed. Consult your pharmacist||
1840|172|R|or local waste disposal company.||
1840|173|B|||
1840|174|A|Information last revised August 2024.||
1840|175|A|Copyright(c) 2025 First Databank, Inc.||
1840|176|B|||
1841|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1841|002|Z|does NOT have all possible information about this product. This||
1841|003|Z|information does not assure that this product is safe, effective,||
1841|004|Z|or appropriate for you. This information is not individual||
1841|005|Z|medical advice and does not substitute for the advice of your||
1841|006|Z|health care professional. Always ask your health care||
1841|007|Z|professional for complete information about this product and your||
1841|008|Z|specific health needs.||
1841|009|B|||
1841|010|T|OBETICHOLIC ACID - ORAL||
1841|011|F|(oh-BET-i-KOE-lik AS-id)||
1841|012|B|||
1841|013|C|COMMON BRAND NAME(S): Ocaliva||
1841|014|B|||
1841|015|W|WARNING:  Although this medication is used to treat a certain||
1841|016|W|liver disease, it has caused serious (even fatal) worsening of||
1841|017|W|liver function. Before starting treatment with this medication,||
1841|018|W|your doctor should order lab tests to see if you have severe||
1841|019|W|liver disease. This medication should not be used by people with||
1841|020|W|certain types of liver disease. Consult your doctor for more||
1841|021|W|details. Your doctor should also order lab tests and watch for||
1841|022|W|symptoms of worsening liver function during treatment (see also||
1841|023|W|Side Effects section). Talk with your doctor about the risks and||
1841|024|W|benefits of taking this medication.||
1841|025|B|||
1841|026|U|USES:  This medication is used alone or in combination treatment||
1841|027|U|for a certain liver disease (primary biliary cholangitis-PBC).||
1841|028|U|This disease slowly destroys the bile ducts in the liver. When||
1841|029|U|bile ducts are damaged, harmful substances can build up in bile||
1841|030|U|and scar the liver. Obeticholic acid works by causing your liver||
1841|031|U|to make less bile, and by helping bile flow out of the liver.||
1841|032|B|||
1841|033|H|HOW TO USE:  Read the Medication Guide provided by your||
1841|034|H|pharmacist before you start taking obeticholic acid and each time||
1841|035|H|you get a refill. If you have any questions, ask your doctor or||
1841|036|H|pharmacist.||
1841|037|H|   Take this medication by mouth with or without food as directed||
1841|038|H|by your doctor, usually once a day. The dosage is based on your||
1841|039|H|medical condition, lab tests, and response to treatment. If you||
1841|040|H|have side effects, your doctor may direct you to temporarily stop||
1841|041|H|taking this medication, or to take it less often. Ask your doctor||
1841|042|H|or pharmacist if you are not sure about your dosage instructions.||
1841|043|H|   Use this medication regularly to get the most benefit from it.||
1841|044|H|To help you remember, take it at the same time each day.||
1841|045|H|   If you also take certain other drugs to lower your cholesterol||
1841|046|H|(bile acid-binding resins such as cholestyramine or colestipol),||
1841|047|H|take obeticholic acid at least 4 hours before or at least 4 hours||
1841|048|H|after taking these medications. These products can keep you from||
1841|049|H|absorbing obeticholic acid fully.||
1841|050|H|   Tell your doctor if your condition does not get better or if||
1841|051|H|it gets worse.||
1841|052|B|||
1841|053|S|SIDE EFFECTS:  Tiredness, mouth/throat pain, or fast/pounding||
1841|054|S|heartbeat may occur. If any of these effects last or get worse,||
1841|055|S|tell your doctor or pharmacist promptly.||
1841|056|S|   Remember that this medication has been prescribed because your||
1841|057|S|doctor has judged that the benefit to you is greater than the||
1841|058|S|risk of side effects. Many people using this medication do not||
1841|059|S|have serious side effects.||
1841|060|S|   Tell your doctor right away if you have any serious side||
1841|061|S|effects, including: new or worsening skin itching.||
1841|062|S|   Although this medication is used to treat primary biliary||
1841|063|S|cholangitis (PBC), it may also cause worsening of some liver||
1841|064|S|symptoms. Get medical help right away if you have symptoms such||
1841|065|S|as nausea/vomiting/diarrhea that doesn't stop, loss of appetite,||
1841|066|S|stomach/abdominal pain, yellowing eyes/skin, dark urine, black||
1841|067|S|stools, vomit that looks like coffee grounds, swollen abdomen,||
1841|068|S|unusual decreased urination, dizziness/lightheadedness, fever,||
1841|069|S|chills, or mental/mood changes.||
1841|070|S|   A very serious allergic reaction to this drug is rare.||
1841|071|S|However, get medical help right away if you notice any symptoms||
1841|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1841|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1841|074|S|breathing.||
1841|075|S|   This is not a complete list of possible side effects. If you||
1841|076|S|notice other effects not listed above, contact your doctor or||
1841|077|S|pharmacist.||
1841|078|S|   In the US -||
1841|079|S|   Call your doctor for medical advice about side effects. You||
1841|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1841|081|S|www.fda.gov/medwatch.||
1841|082|S|   In Canada - Call your doctor for medical advice about side||
1841|083|S|effects. You may report side effects to Health Canada at||
1841|084|S|1-866-234-2345.||
1841|085|B|||
1841|086|P|PRECAUTIONS:  See also Warning section.||
1841|087|P|   Before taking obeticholic acid, tell your doctor or pharmacist||
1841|088|P|if you are allergic to it; or if you have any other allergies.||
1841|089|P|This product may contain inactive ingredients which can cause||
1841|090|P|allergic reactions or other problems. Talk to your pharmacist for||
1841|091|P|more details.||
1841|092|P|   Before using this medication, tell your doctor or pharmacist||
1841|093|P|your medical history, especially of: bile duct blockage.||
1841|094|P|   Before having surgery, tell your doctor or dentist about all||
1841|095|P|the products you use (including prescription drugs,||
1841|096|P|nonprescription drugs, and herbal products).||
1841|097|P|   During pregnancy, this medication should be used only when||
1841|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
1841|099|P|   It is unknown if this medication passes into breast milk.||
1841|100|P|Consult your doctor before breastfeeding.||
1841|101|B|||
1841|102|I|DRUG INTERACTIONS:  See also How to Use section.||
1841|103|I|   Drug interactions may change how your medications work or||
1841|104|I|increase your risk for serious side effects. This document does||
1841|105|I|not contain all possible drug interactions. Keep a list of all||
1841|106|I|the products you use (including prescription/nonprescription||
1841|107|I|drugs and herbal products) and share it with your doctor and||
1841|108|I|pharmacist. Do not start, stop, or change the dosage of any||
1841|109|I|medicines without your doctor's approval.||
1841|110|I|   A product that may interact with this drug is: fezolinetant.||
1841|111|B|||
1841|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1841|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1841|114|O|poison control center right away. US residents can call||
1841|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1841|116|B|||
1841|117|N|NOTES:  Do not share this medication with others.||
1841|118|N|   Lab and/or medical tests (such as cholesterol levels, liver||
1841|119|N|function) should be done before you start taking this medication||
1841|120|N|and while you are taking it. Keep all medical and lab||
1841|121|N|appointments.||
1841|122|B|||
1841|123|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1841|124|D|remember. If it is near the time of the next dose, skip the||
1841|125|D|missed dose. Take your next dose at the regular time. Do not||
1841|126|D|double the dose to catch up.||
1841|127|B|||
1841|128|R|STORAGE:  Store at room temperature away from light and moisture.||
1841|129|R|Do not store in the bathroom. Keep all medications away from||
1841|130|R|children and pets.||
1841|131|R|   Do not flush medications down the toilet or pour them into a||
1841|132|R|drain unless instructed to do so. Properly discard this product||
1841|133|R|when it is expired or no longer needed. Consult your pharmacist||
1841|134|R|or local waste disposal company.||
1841|135|B|||
1841|136|A|Information last revised December 2024.||
1841|137|A|Copyright(c) 2025 First Databank, Inc.||
1841|138|B|||
1842|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1842|002|Z|does NOT have all possible information about this product. This||
1842|003|Z|information does not assure that this product is safe, effective,||
1842|004|Z|or appropriate for you. This information is not individual||
1842|005|Z|medical advice and does not substitute for the advice of your||
1842|006|Z|health care professional. Always ask your health care||
1842|007|Z|professional for complete information about this product and your||
1842|008|Z|specific health needs.||
1842|009|B|||
1842|010|T|C1-ESTERASE INHIBITOR - SUBCUTANEOUS INJECTION||
1842|011|B|||
1842|012|C|COMMON BRAND NAME(S): Haegarda||
1842|013|B|||
1842|014|U|USES:  This medication is used to help prevent swelling and||
1842|015|U|painful attacks caused by a certain inherited disease (hereditary||
1842|016|U|angioedema-HAE). Most people with this disease have too little of||
1842|017|U|a certain substance produced by your body (C1-esterase||
1842|018|U|inhibitor). Some people with this disease have normal amounts of||
1842|019|U|the substance, but it doesn't work right. Anxiety, stress,||
1842|020|U|illness, or surgery may trigger attacks in some people. Symptoms||
1842|021|U|such as rapid swelling of the hands, feet, limbs, face, tongue,||
1842|022|U|or throat can occur. Swelling of the belly may cause symptoms||
1842|023|U|such as severe pain, nausea, vomiting, or diarrhea. This||
1842|024|U|medication works by increasing the amount of C1-esterase||
1842|025|U|inhibitor in your body.||
1842|026|U|   This medication should not be used to treat sudden swelling||
1842|027|U|attacks caused by HAE. Ask your doctor ahead of time what to do||
1842|028|U|if you have a sudden attack.||
1842|029|B|||
1842|030|H|HOW TO USE:  Read the Patient Information Leaflet and||
1842|031|H|Instructions for Use if available from your pharmacist before you||
1842|032|H|start using this medication and each time you get a refill. Ask||
1842|033|H|your health care professional how to prepare and use this||
1842|034|H|medication. If you have any questions, ask your doctor or||
1842|035|H|pharmacist.||
1842|036|H|   Inject this medication under the skin as directed by your||
1842|037|H|doctor, usually twice a week (every 3 or 4 days). The injection||
1842|038|H|is given in the abdomen or another site as directed. The dosage||
1842|039|H|is based on your medical condition, weight, and response to||
1842|040|H|treatment.||
1842|041|H|   Make sure that the medication and mixing solution are at room||
1842|042|H|temperature before mixing. Before using, check this product for||
1842|043|H|particles or discoloration. If either is present, do not use the||
1842|044|H|liquid. Before injecting each dose, clean the skin you are going||
1842|045|H|to inject into (the injection site) with rubbing alcohol. Change||
1842|046|H|the injection site each time to lessen injury under the skin. Do||
1842|047|H|not inject into skin that is itchy, swollen, painful, bruised, or||
1842|048|H|red, or has scars or stretch marks. To lessen bruising, do not||
1842|049|H|rub the injection site after a shot. Learn how to store and||
1842|050|H|discard medical supplies safely.||
1842|051|H|   Use this medication regularly to get the most benefit from it.||
1842|052|H|To help you remember, mark your calendar with a reminder.||
1842|053|H|   Tell your doctor if your condition does not get better or if||
1842|054|H|it gets worse.||
1842|055|B|||
1842|056|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
1842|057|S|cold-like symptoms (such as runny/stuffy nose, sneezing, watery||
1842|058|S|eyes), or dizziness may occur. If any of these effects last or||
1842|059|S|get worse, tell your doctor or pharmacist promptly.||
1842|060|S|   Remember that this medication has been prescribed because your||
1842|061|S|doctor has judged that the benefit to you is greater than the||
1842|062|S|risk of side effects. Many people using this medication do not||
1842|063|S|have serious side effects.||
1842|064|S|   This medication may rarely cause serious problems from blood||
1842|065|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1842|066|S|legs). You may be at increased risk for blood clots if you have a||
1842|067|S|history of blood clots, heart/blood vessel disease, heart||
1842|068|S|failure, stroke, or if you are immobile (such as on very long||
1842|069|S|plane flights or being bedridden). If you use estrogen-containing||
1842|070|S|products, these may also increase your risk. Before using this||
1842|071|S|medication, if you have any of these conditions report them to||
1842|072|S|your doctor or pharmacist. Get medical help right away if any of||
1842|073|S|these side effects occur: shortness of breath/rapid breathing,||
1842|074|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1842|075|S|dizziness/fainting, new pain/swelling/warmth in the groin/calf,||
1842|076|S|sudden/severe headaches, trouble speaking, weakness on one side||
1842|077|S|of the body, sudden vision changes.||
1842|078|S|   A very serious allergic reaction to this drug is rare.||
1842|079|S|However, get medical help right away if you notice any symptoms||
1842|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1842|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1842|082|S|breathing.||
1842|083|S|   This is not a complete list of possible side effects. If you||
1842|084|S|notice other effects not listed above, contact your doctor or||
1842|085|S|pharmacist.||
1842|086|S|   In the US -||
1842|087|S|   Call your doctor for medical advice about side effects. You||
1842|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1842|089|S|www.fda.gov/medwatch.||
1842|090|S|   In Canada - Call your doctor for medical advice about side||
1842|091|S|effects. You may report side effects to Health Canada at||
1842|092|S|1-866-234-2345.||
1842|093|B|||
1842|094|P|PRECAUTIONS:  Before using C1-esterase inhibitor, tell your||
1842|095|P|doctor or pharmacist if you are allergic to it; or if you have||
1842|096|P|any other allergies. This product may contain inactive||
1842|097|P|ingredients, which can cause allergic reactions or other||
1842|098|P|problems. Talk to your pharmacist for more details.||
1842|099|P|   Before using this medication, tell your doctor or pharmacist||
1842|100|P|your medical history, especially of: blood clots (such as in the||
1842|101|P|lungs, legs).||
1842|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1842|103|P|can make you more dizzy. Do not drive, use machinery, or do||
1842|104|P|anything that needs alertness until you can do it safely. Limit||
1842|105|P|alcoholic beverages. Talk to your doctor if you are using||
1842|106|P|marijuana (cannabis).||
1842|107|P|   This medication is made from human blood. Even though the||
1842|108|P|blood is carefully tested, and this medication goes through a||
1842|109|P|special manufacturing process, there is an extremely small chance||
1842|110|P|that you may get infections from the medication (for example,||
1842|111|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
1842|112|P|more information.||
1842|113|P|   Before having surgery, tell your doctor or dentist about all||
1842|114|P|the products you use (including prescription drugs,||
1842|115|P|nonprescription drugs, and herbal products).||
1842|116|P|   During pregnancy, this medication should be used only when||
1842|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
1842|118|P|   It is unknown if this drug passes into breast milk. Consult||
1842|119|P|your doctor before breastfeeding.||
1842|120|B|||
1842|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1842|122|I|medications work or increase your risk for serious side effects.||
1842|123|I|This document does not contain all possible drug interactions.||
1842|124|I|Keep a list of all the products you use (including||
1842|125|I|prescription/nonprescription drugs and herbal products) and share||
1842|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
1842|127|I|the dosage of any medicines without your doctor's approval.||
1842|128|B|||
1842|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1842|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1842|131|O|poison control center right away. US residents can call||
1842|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1842|133|B|||
1842|134|N|NOTES:  Do not share this medication with others.||
1842|135|N|   Before traveling, talk to your doctor to make sure you have||
1842|136|N|enough of this medication.||
1842|137|B|||
1842|138|D|MISSED DOSE:  It is important to get each dose of this medication||
1842|139|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1842|140|D|right away for a new dosing schedule. Do not double the dose to||
1842|141|D|catch up.||
1842|142|B|||
1842|143|R|STORAGE:  Store the unmixed vial in the refrigerator or at room||
1842|144|R|temperature. Do not freeze. Keep the medication in the original||
1842|145|R|carton to protect from light. After mixing, use this medication||
1842|146|R|right away or within 8 hours. Do not refrigerate the mixed||
1842|147|R|solution. Discard any unused portion. Keep all medications away||
1842|148|R|from children and pets.||
1842|149|R|   Do not flush medications down the toilet or pour them into a||
1842|150|R|drain unless instructed to do so. Properly discard this product||
1842|151|R|when it is expired or no longer needed. Consult your pharmacist||
1842|152|R|or local waste disposal company.||
1842|153|B|||
1842|154|A|Information last revised October 2024.||
1842|155|A|Copyright(c) 2025 First Databank, Inc.||
1842|156|B|||
1843|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1843|002|Z|does NOT have all possible information about this product. This||
1843|003|Z|information does not assure that this product is safe, effective,||
1843|004|Z|or appropriate for you. This information is not individual||
1843|005|Z|medical advice and does not substitute for the advice of your||
1843|006|Z|health care professional. Always ask your health care||
1843|007|Z|professional for complete information about this product and your||
1843|008|Z|specific health needs.||
1843|009|B|||
1843|010|T|GUSELKUMAB - INJECTION||
1843|011|F|(GUE-sel-KOO-mab)||
1843|012|B|||
1843|013|C|COMMON BRAND NAME(S): Tremfya||
1843|014|B|||
1843|015|U|USES:  This medication is used to treat plaque psoriasis and||
1843|016|U|psoriatic arthritis. It is also used to treat certain bowel||
1843|017|U|diseases (Crohn's disease, ulcerative colitis). Guselkumab||
1843|018|U|belongs to a class of drugs known as monoclonal antibodies. It||
1843|019|U|works by blocking a certain natural substance in your body||
1843|020|U|(interleukin-23) that may cause inflammation and swelling.||
1843|021|B|||
1843|022|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1843|023|H|provided by your pharmacist before you start using this||
1843|024|H|medication and each time you get a refill. Ask your health care||
1843|025|H|professional how to prepare and use this medication. If you have||
1843|026|H|any questions, ask your doctor or pharmacist.||
1843|027|H|   Before treatment with this medication, your doctor will test||
1843|028|H|you for tuberculosis (TB). Your doctor should also monitor you||
1843|029|H|for symptoms of TB during and after treatment with this drug. If||
1843|030|H|needed, treatment for tuberculosis or other infections should be||
1843|031|H|given before receiving this medication.||
1843|032|H|   Inject this medication under the skin as directed by your||
1843|033|H|doctor. The injection is given in the upper arms, thighs, or||
1843|034|H|abdomen (except for a 2-inch area around your belly button). In||
1843|035|H|children, some forms may only be given in the thighs or abdomen.||
1843|036|H|If treating Crohn's disease or ulcerative colitis, the first 3||
1843|037|H|doses of this medication may be given by injection into a vein by||
1843|038|H|a healthcare professional. The dosage is based on your medical||
1843|039|H|condition and response to treatment.||
1843|040|H|   Take the medication out of the refrigerator at least 30||
1843|041|H|minutes before you inject it to allow it to reach room||
1843|042|H|temperature. Do not warm up this medication any other way (for||
1843|043|H|example, do not heat it in the microwave, place it in hot water,||
1843|044|H|or leave it in direct sunlight). Do not shake the medication.||
1843|045|H|This product may contain small white or clear particles. Before||
1843|046|H|using, check this product for cloudiness, large particles, or||
1843|047|H|discoloration. If you see any of these things, do not use the||
1843|048|H|liquid. Before injecting each dose, clean the skin you are going||
1843|049|H|to inject into (the injection site) with rubbing alcohol. Change||
1843|050|H|the injection site each time to lessen injury under the skin. Do||
1843|051|H|not inject into skin that is tender, bruised, red, hard, thick,||
1843|052|H|scaly, or affected by psoriasis. To lessen bruising, do not rub||
1843|053|H|the injection site after a shot. Learn how to store and discard||
1843|054|H|medical supplies safely.||
1843|055|H|   Use this medication regularly to get the most benefit from it.||
1843|056|H|To help you remember, mark your calendar with a reminder.||
1843|057|H|   Tell your doctor if your condition does not get better or if||
1843|058|H|it gets worse.||
1843|059|B|||
1843|060|S|SIDE EFFECTS:  Bruising, redness, itching, pain, or swelling at||
1843|061|S|the injection site may occur. If any of these effects last or get||
1843|062|S|worse, tell your doctor or pharmacist promptly.||
1843|063|S|   Remember that this medication has been prescribed because your||
1843|064|S|doctor has judged that the benefit to you is greater than the||
1843|065|S|risk of side effects. Many people using this medication do not||
1843|066|S|have serious side effects.||
1843|067|S|   Tell your doctor right away if you have any serious side||
1843|068|S|effects, including: signs of liver disease (such as||
1843|069|S|nausea/vomiting that doesn't stop, loss of appetite,||
1843|070|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1843|071|S|   This medication may lower your ability to fight infections.||
1843|072|S|This may make you more likely to get a serious (rarely fatal)||
1843|073|S|infection or make any infection you have worse. Tell your doctor||
1843|074|S|right away if you have any signs of infection (such as sore||
1843|075|S|throat that doesn't go away, fever, chills).||
1843|076|S|   A very serious allergic reaction to this drug is rare.||
1843|077|S|However, get medical help right away if you notice any symptoms||
1843|078|S|of a serious allergic reaction, including: rash, itching/swelling||
1843|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1843|080|S|breathing.||
1843|081|S|   This is not a complete list of possible side effects. If you||
1843|082|S|notice other effects not listed above, contact your doctor or||
1843|083|S|pharmacist.||
1843|084|S|   In the US -||
1843|085|S|   Call your doctor for medical advice about side effects. You||
1843|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1843|087|S|www.fda.gov/medwatch.||
1843|088|S|   In Canada - Call your doctor for medical advice about side||
1843|089|S|effects. You may report side effects to Health Canada at||
1843|090|S|1-866-234-2345.||
1843|091|B|||
1843|092|P|PRECAUTIONS:  Before using guselkumab, tell your doctor or||
1843|093|P|pharmacist if you are allergic to it; or if you have any other||
1843|094|P|allergies. This product may contain inactive ingredients, which||
1843|095|P|can cause allergic reactions or other problems. Talk to your||
1843|096|P|pharmacist for more details.||
1843|097|P|   Before using this medication, tell your doctor or pharmacist||
1843|098|P|your medical history, especially of: current/recent/returning||
1843|099|P|infection (such as tuberculosis, herpes).||
1843|100|P|   Guselkumab can make you more likely to get infections or may||
1843|101|P|make current infections worse. Stay away from anyone who has an||
1843|102|P|infection that may easily spread (such as chickenpox, COVID-19,||
1843|103|P|measles, flu). Talk to your doctor if you have been exposed to an||
1843|104|P|infection or for more details.||
1843|105|P|   Tell your health care professional that you are using||
1843|106|P|guselkumab before having any immunizations/vaccinations. Avoid||
1843|107|P|contact with people who have recently received live vaccines||
1843|108|P|(such as flu vaccine inhaled through the nose).||
1843|109|P|   Before having surgery, tell your doctor or dentist about all||
1843|110|P|the products you use (including prescription drugs,||
1843|111|P|nonprescription drugs, and herbal products).||
1843|112|P|   During pregnancy, this medication should be used only when||
1843|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
1843|114|P|   It is unknown if this medication passes into breast milk.||
1843|115|P|Consult your doctor before breastfeeding.||
1843|116|B|||
1843|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1843|118|I|medications work or increase your risk for serious side effects.||
1843|119|I|This document does not contain all possible drug interactions.||
1843|120|I|Keep a list of all the products you use (including||
1843|121|I|prescription/nonprescription drugs and herbal products) and share||
1843|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
1843|123|I|the dosage of any medicines without your doctor's approval.||
1843|124|B|||
1843|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1843|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1843|127|O|poison control center right away. US residents can call||
1843|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1843|129|B|||
1843|130|N|NOTES:  Do not share this medication with others.||
1843|131|N|   Lab and/or medical tests (such as liver function) may be done||
1843|132|N|before you start using this medication and while you are using||
1843|133|N|it. Keep all medical and lab appointments. Consult your doctor||
1843|134|N|for more details.||
1843|135|B|||
1843|136|D|MISSED DOSE:  It is important to get each dose of this medication||
1843|137|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1843|138|D|right away for a new dosing schedule. Do not double the dose to||
1843|139|D|catch up.||
1843|140|B|||
1843|141|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1843|142|R|medication in the original carton to protect from light. Discard||
1843|143|R|any unused portion after use. Keep all medications away from||
1843|144|R|children and pets.||
1843|145|R|   Do not flush medications down the toilet or pour them into a||
1843|146|R|drain unless instructed to do so. Properly discard this product||
1843|147|R|when it is expired or no longer needed. Consult your pharmacist||
1843|148|R|or local waste disposal company.||
1843|149|B|||
1843|150|A|Information last revised October 2025.||
1843|151|A|Copyright(c) 2025 First Databank, Inc.||
1843|152|B|||
1844|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1844|002|Z|does NOT have all possible information about this product. This||
1844|003|Z|information does not assure that this product is safe, effective,||
1844|004|Z|or appropriate for you. This information is not individual||
1844|005|Z|medical advice and does not substitute for the advice of your||
1844|006|Z|health care professional. Always ask your health care||
1844|007|Z|professional for complete information about this product and your||
1844|008|Z|specific health needs.||
1844|009|B|||
1844|010|T|SOFOSBUVIR/VELPATASVIR/VOXILAPREVIR - ORAL||
1844|011|F|(soe-FOS-bue-vir/vel-PAT-as-vir/VOX-i-LA-pre-vir)||
1844|012|B|||
1844|013|C|COMMON BRAND NAME(S): Vosevi||
1844|014|B|||
1844|015|W|WARNING:  Although this product is used to treat hepatitis C, it||
1844|016|W|may rarely cause serious liver problems. It may make other liver||
1844|017|W|problems (such as hepatitis B) get worse. Before starting this||
1844|018|W|product, tell your doctor if you have ever had hepatitis B or any||
1844|019|W|other liver problems. See also Precautions section. Tell your||
1844|020|W|doctor right away if you have new or worsening symptoms of liver||
1844|021|W|disease, such as nausea/vomiting that doesn't stop, loss of||
1844|022|W|appetite, stomach/abdominal pain, dark urine or yellowing||
1844|023|W|eyes/skin.||
1844|024|B|||
1844|025|U|USES:  This medication contains 3 drugs: sofosbuvir, velpatasvir,||
1844|026|U|and voxilaprevir. This medication is used to treat chronic||
1844|027|U|(long-lasting) hepatitis C, a viral infection of the liver. These||
1844|028|U|drugs work by reducing the amount of hepatitis C virus in your||
1844|029|U|body, which helps your immune system fight the infection and may||
1844|030|U|help your liver recover. Chronic hepatitis C infection can cause||
1844|031|U|serious liver problems such as scarring (cirrhosis), or liver||
1844|032|U|cancer.||
1844|033|U|   It is not known if this treatment can prevent you from passing||
1844|034|U|the virus to others. Do not share needles, and practice "safer||
1844|035|U|sex" (including the use of latex condoms) to lower the risk of||
1844|036|U|passing the virus to others.||
1844|037|B|||
1844|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1844|039|H|from your pharmacist before you start taking||
1844|040|H|sofosbuvir/velpatasvir/voxilaprevir and each time you get a||
1844|041|H|refill. If you have any questions, ask your doctor or pharmacist.||
1844|042|H|   Take this medication by mouth with food as directed by your||
1844|043|H|doctor, usually once daily.||
1844|044|H|   This medication works best when the amount of drug in your||
1844|045|H|body is kept at a constant level. Take this drug at evenly spaced||
1844|046|H|times. To help you remember, take it at the same time each day.||
1844|047|H|   Continue to take this medication for the full length of time||
1844|048|H|prescribed, even if symptoms disappear after a short time.||
1844|049|H|Stopping the medication too early may result in a return of the||
1844|050|H|infection.||
1844|051|H|   Antacids lower the absorption of velpatasvir. If you are||
1844|052|H|taking an antacid, take it at least 4 hours before or 4 hours||
1844|053|H|after this medication.||
1844|054|H|   Other acid-lowering medications for indigestion, heartburn, or||
1844|055|H|ulcers (such as prescription or over-the-counter medications||
1844|056|H|including famotidine, omeprazole) may prevent velpatasvir from||
1844|057|H|working. Ask your doctor or pharmacist how to use these||
1844|058|H|medications safely.||
1844|059|B|||
1844|060|S|SIDE EFFECTS:  See also Warning section.||
1844|061|S|   Tiredness, headache, nausea, diarrhea, or difficulty sleeping||
1844|062|S|may occur. If any of these effects last or get worse, tell your||
1844|063|S|doctor or pharmacist promptly.||
1844|064|S|   Remember that this medication has been prescribed because your||
1844|065|S|doctor has judged that the benefit to you is greater than the||
1844|066|S|risk of side effects. Many people using this medication do not||
1844|067|S|have serious side effects.||
1844|068|S|   A very serious allergic reaction to this drug is rare.||
1844|069|S|However, get medical help right away if you notice any symptoms||
1844|070|S|of a serious allergic reaction, including: rash, itching/swelling||
1844|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1844|072|S|breathing.||
1844|073|S|   This is not a complete list of possible side effects. If you||
1844|074|S|notice other effects not listed above, contact your doctor or||
1844|075|S|pharmacist.||
1844|076|S|   In the US -||
1844|077|S|   Call your doctor for medical advice about side effects. You||
1844|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1844|079|S|www.fda.gov/medwatch.||
1844|080|S|   In Canada - Call your doctor for medical advice about side||
1844|081|S|effects. You may report side effects to Health Canada at||
1844|082|S|1-866-234-2345.||
1844|083|B|||
1844|084|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1844|085|P|pharmacist if you are allergic to sofosbuvir or velpatasvir or||
1844|086|P|voxilaprevir; or if you have any other allergies. This product||
1844|087|P|may contain inactive ingredients, which can cause allergic||
1844|088|P|reactions or other problems. Talk to your pharmacist for more||
1844|089|P|details.||
1844|090|P|   Before using this medication, tell your doctor or pharmacist||
1844|091|P|your medical history, especially of: other liver problems (such||
1844|092|P|as hepatitis B, liver cancer), overuse of or addiction to||
1844|093|P|alcohol, diabetes.||
1844|094|P|   If you have diabetes, your blood sugar may be lower with||
1844|095|P|hepatitis C treatment. This can increase your risk of low blood||
1844|096|P|sugar, so your doctor may adjust your diabetes treatment plan.||
1844|097|P|Tell your doctor right away if you have symptoms of low blood||
1844|098|P|sugar such as sudden sweating, shaking, fast heartbeat, hunger,||
1844|099|P|blurred vision, dizziness, or tingling hands/feet.||
1844|100|P|   Before having surgery, tell your doctor or dentist about all||
1844|101|P|the products you use (including prescription drugs,||
1844|102|P|nonprescription drugs, and herbal products).||
1844|103|P|   During pregnancy, this medication should be used only when||
1844|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
1844|105|P|   It is unknown if this medication passes into breast milk.||
1844|106|P|Consult your doctor before breastfeeding.||
1844|107|B|||
1844|108|I|DRUG INTERACTIONS:  See also How to Use section.||
1844|109|I|   Drug interactions may change how your medications work or||
1844|110|I|increase your risk for serious side effects. This document does||
1844|111|I|not contain all possible drug interactions. Keep a list of all||
1844|112|I|the products you use (including prescription/nonprescription||
1844|113|I|drugs and herbal products) and share it with your doctor and||
1844|114|I|pharmacist. Do not start, stop, or change the dosage of any||
1844|115|I|medicines without your doctor's approval.||
1844|116|I|   A product that may interact with this drug is: amiodarone.||
1844|117|I|   This medication can slow down the removal of other medications||
1844|118|I|from your body, which may affect how they work. Examples of||
1844|119|I|affected drugs include pitavastatin, rosuvastatin, topotecan,||
1844|120|I|among others.||
1844|121|I|   Other medications can affect the removal of this medication||
1844|122|I|from your body, which may affect how this medication works.||
1844|123|I|Examples include atazanavir, cyclosporine, efavirenz, lopinavir,||
1844|124|I|rifamycins (such as rifampin, rifabutin), St. John's wort,||
1844|125|I|tipranavir/ritonavir, drugs used to treat seizures (such as||
1844|126|I|phenobarbital, carbamazepine, phenytoin, primidone), among||
1844|127|I|others.||
1844|128|I|   Do not take this medication with other products that contain||
1844|129|I|sofosbuvir or velpatasvir.||
1844|130|B|||
1844|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1844|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1844|133|O|poison control center right away. US residents can call||
1844|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1844|135|B|||
1844|136|N|NOTES:  Do not share this medication with others.||
1844|137|N|   Lab tests (such as liver function, tests for hepatitis B and||
1844|138|N|C) should be done before you start using this medication, while||
1844|139|N|you are using it, and after completing treatment. Keep all||
1844|140|N|medical and lab appointments.||
1844|141|B|||
1844|142|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1844|143|D|remember. If it is near the time of the next dose, skip the||
1844|144|D|missed dose. Take your next dose at the regular time. Do not||
1844|145|D|double the dose to catch up.||
1844|146|B|||
1844|147|R|STORAGE:  Store in the original container at room temperature||
1844|148|R|away from light and moisture. Do not store in the bathroom. Keep||
1844|149|R|all medications away from children and pets.||
1844|150|R|   Do not flush medications down the toilet or pour them into a||
1844|151|R|drain unless instructed to do so. Properly discard this product||
1844|152|R|when it is expired or no longer needed. Consult your pharmacist||
1844|153|R|or local waste disposal company.||
1844|154|B|||
1844|155|A|Information last revised July 2024.||
1844|156|A|Copyright(c) 2025 First Databank, Inc.||
1844|157|B|||
1846|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1846|002|Z|does NOT have all possible information about this product. This||
1846|003|Z|information does not assure that this product is safe, effective,||
1846|004|Z|or appropriate for you. This information is not individual||
1846|005|Z|medical advice and does not substitute for the advice of your||
1846|006|Z|health care professional. Always ask your health care||
1846|007|Z|professional for complete information about this product and your||
1846|008|Z|specific health needs.||
1846|009|B|||
1846|010|T|NERATINIB - ORAL||
1846|011|F|(ne-RA-ti-nib)||
1846|012|B|||
1846|013|C|COMMON BRAND NAME(S): Nerlynx||
1846|014|B|||
1846|015|U|USES:  Neratinib is used to treat breast cancer. Neratinib||
1846|016|U|belongs to a class of drugs known as kinase inhibitors. It works||
1846|017|U|by slowing or stopping the growth of cancer cells.||
1846|018|B|||
1846|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1846|020|H|from your pharmacist before you start taking neratinib and each||
1846|021|H|time you get a refill. If you have any questions, ask your doctor||
1846|022|H|or pharmacist.||
1846|023|H|   Take this medication by mouth with food as directed by your||
1846|024|H|doctor, usually once daily. Swallow the medication whole. Do not||
1846|025|H|crush, chew, or split the tablets. Avoid handling or touching||
1846|026|H|crushed or broken tablets.||
1846|027|H|   Use this medication regularly to get the most benefit from it.||
1846|028|H|To help you remember, take it at the same time each day.||
1846|029|H|   The dosage is based on your medical condition and response to||
1846|030|H|treatment. To reduce your risk of side effects, your doctor may||
1846|031|H|direct you to start this medication at a low dose and gradually||
1846|032|H|increase your dose. Follow your doctor's instructions carefully.||
1846|033|H|Do not increase your dose or use this drug more often or for||
1846|034|H|longer than prescribed. Your condition will not improve any||
1846|035|H|faster, and your risk of serious side effects will increase.||
1846|036|H|   To help prevent diarrhea, your doctor should prescribe||
1846|037|H|anti-diarrhea medication (such as loperamide) for you to take on||
1846|038|H|a regular schedule during the first 2 months of treatment with||
1846|039|H|neratinib. Follow your doctor's directions to keep taking||
1846|040|H|anti-diarrhea medication on a regular schedule or to take it only||
1846|041|H|as needed.||
1846|042|H|   Medications that reduce stomach acid (such as antacids, proton||
1846|043|H|pump inhibitors/PPIs, H2 blockers) may make neratinib work less||
1846|044|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
1846|045|H|using this medication. If you take antacids, take neratinib at||
1846|046|H|least 3 hours after taking the antacid. If you take H2 blockers||
1846|047|H|(such as famotidine, nizatidine), take neratinib at least 2 hours||
1846|048|H|before or at least 10 hours after taking the H2 blocker.||
1846|049|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1846|050|H|using this medication unless your doctor or pharmacist says you||
1846|051|H|may do so safely. Grapefruit can increase the chance of side||
1846|052|H|effects with this medicine. Ask your doctor or pharmacist for||
1846|053|H|more details.||
1846|054|H|   Since this drug can be absorbed through the skin and lungs and||
1846|055|H|may harm an unborn baby, women who are pregnant or who may become||
1846|056|H|pregnant should not handle this medication or breathe the dust||
1846|057|H|from the tablets.||
1846|058|B|||
1846|059|S|SIDE EFFECTS:  Nausea, vomiting, mouth sores/pain,||
1846|060|S|stomach/abdominal pain, loss of appetite, weight loss, tiredness,||
1846|061|S|dry skin, nail changes, or muscle spasms may occur. If any of||
1846|062|S|these effects last or get worse, tell your doctor or pharmacist||
1846|063|S|promptly.||
1846|064|S|   People using this medication may have serious side effects.||
1846|065|S|However, you have been prescribed this drug because your doctor||
1846|066|S|has judged that the benefit to you is greater than the risk of||
1846|067|S|side effects. Careful monitoring by your doctor may decrease your||
1846|068|S|risk.||
1846|069|S|   Diarrhea is a common side effect. Drink plenty of fluids as||
1846|070|S|directed by your doctor to lower your risk of dehydration. Your||
1846|071|S|doctor should prescribe anti-diarrhea medication (such as||
1846|072|S|loperamide) to help control your symptoms. Tell your doctor right||
1846|073|S|away if you develop diarrhea that is severe or doesn't stop, or||
1846|074|S|signs of dehydration (such as unusual decreased urination,||
1846|075|S|unusual dry mouth/thirst, fast heartbeat,||
1846|076|S|dizziness/lightheadedness). Your doctor may prescribe additional||
1846|077|S|anti-diarrhea medications or temporarily stop/adjust your dose of||
1846|078|S|neratinib.||
1846|079|S|   Tell your doctor right away if you have any serious side||
1846|080|S|effects, including: severe stomach/abdominal pain, yellowing||
1846|081|S|eyes/skin, dark urine, signs of kidney problems (such as change||
1846|082|S|in the amount of urine).||
1846|083|S|   A very serious allergic reaction to this drug is rare.||
1846|084|S|However, get medical help right away if you notice any symptoms||
1846|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1846|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1846|087|S|breathing.||
1846|088|S|   Neratinib can commonly cause a mild rash that is usually not||
1846|089|S|serious. However, you may not be able to tell it apart from a||
1846|090|S|rare rash that could be a sign of a severe allergic reaction. Get||
1846|091|S|medical help right away if you develop any rash.||
1846|092|S|   This is not a complete list of possible side effects. If you||
1846|093|S|notice other effects not listed above, contact your doctor or||
1846|094|S|pharmacist.||
1846|095|S|   In the US -||
1846|096|S|   Call your doctor for medical advice about side effects. You||
1846|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1846|098|S|www.fda.gov/medwatch.||
1846|099|S|   In Canada - Call your doctor for medical advice about side||
1846|100|S|effects. You may report side effects to Health Canada at||
1846|101|S|1-866-234-2345.||
1846|102|B|||
1846|103|P|PRECAUTIONS:  Before taking neratinib, tell your doctor or||
1846|104|P|pharmacist if you are allergic to it; or if you have any other||
1846|105|P|allergies. This product may contain inactive ingredients, which||
1846|106|P|can cause allergic reactions or other problems. Talk to your||
1846|107|P|pharmacist for more details.||
1846|108|P|   Before using this medication, tell your doctor or pharmacist||
1846|109|P|your medical history, especially of: liver disease.||
1846|110|P|   Before having surgery, tell your doctor or dentist about all||
1846|111|P|the products you use (including prescription drugs,||
1846|112|P|nonprescription drugs, and herbal products).||
1846|113|P|   Since this drug can be absorbed through the skin and lungs and||
1846|114|P|may harm an unborn baby, women who are pregnant or who may become||
1846|115|P|pregnant should not handle this medication or breathe the dust||
1846|116|P|from the tablets.||
1846|117|P|   Tell your doctor if you are pregnant or plan to become||
1846|118|P|pregnant. You should not become pregnant while using neratinib.||
1846|119|P|Neratinib may harm an unborn baby. Your doctor should order a||
1846|120|P|pregnancy test before you start this medication. Women using this||
1846|121|P|medication should ask about reliable forms of birth control||
1846|122|P|during treatment and for 1 month after the last dose. Men using||
1846|123|P|this medication should ask about reliable forms of birth control||
1846|124|P|during treatment and for 3 months after the last dose. If you or||
1846|125|P|your partner becomes pregnant, talk to your doctor right away||
1846|126|P|about the risks and benefits of this medication.||
1846|127|P|   It is unknown if this medication passes into breast milk.||
1846|128|P|Because of the possible risk to the infant, breastfeeding is not||
1846|129|P|recommended while using this medication and for at least 1 month||
1846|130|P|after the last dose. Consult your doctor before breastfeeding.||
1846|131|B|||
1846|132|I|DRUG INTERACTIONS:  See also How to Use section.||
1846|133|I|   Drug interactions may change how your medications work or||
1846|134|I|increase your risk for serious side effects. This document does||
1846|135|I|not contain all possible drug interactions. Keep a list of all||
1846|136|I|the products you use (including prescription/nonprescription||
1846|137|I|drugs and herbal products) and share it with your doctor and||
1846|138|I|pharmacist. Do not start, stop, or change the dosage of any||
1846|139|I|medicines without your doctor's approval.||
1846|140|I|   Other medications can affect the removal of neratinib from||
1846|141|I|your body, which may affect how neratinib works. Examples include||
1846|142|I|azole antifungals (such as ketoconazole, itraconazole), macrolide||
1846|143|I|antibiotics (such as clarithromycin), nefazodone, HIV protease||
1846|144|I|inhibitors (such as nelfinavir), rifamycins (such as rifabutin,||
1846|145|I|rifampin), ritonavir, St. John's wort, drugs used to treat||
1846|146|I|seizures (such as carbamazepine, phenytoin), telithromycin, among||
1846|147|I|others.||
1846|148|B|||
1846|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1846|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1846|151|O|poison control center right away. US residents can call||
1846|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1846|153|B|||
1846|154|N|NOTES:  Do not share this medication with others.||
1846|155|N|   Lab and/or medical tests (such as liver function) should be||
1846|156|N|done while you are taking this medication. Keep all medical and||
1846|157|N|lab appointments.||
1846|158|B|||
1846|159|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1846|160|D|next dose at the regular time. Do not double the dose to catch||
1846|161|D|up.||
1846|162|B|||
1846|163|R|STORAGE:  Store at room temperature away from light and moisture.||
1846|164|R|Do not store in the bathroom. Keep all medications away from||
1846|165|R|children and pets.||
1846|166|R|   Do not flush medications down the toilet or pour them into a||
1846|167|R|drain unless instructed to do so. Properly discard this product||
1846|168|R|when it is expired or no longer needed. Consult your pharmacist||
1846|169|R|or local waste disposal company.||
1846|170|B|||
1846|171|M|MEDICAL ALERT:  Your condition can cause complications in a||
1846|172|M|medical emergency. For information about enrolling in MedicAlert,||
1846|173|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1846|174|B|||
1846|175|A|Information last revised June 2025.||
1846|176|A|Copyright(c) 2025 First Databank, Inc.||
1846|177|B|||
1847|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1847|002|Z|does NOT have all possible information about this product. This||
1847|003|Z|information does not assure that this product is safe, effective,||
1847|004|Z|or appropriate for you. This information is not individual||
1847|005|Z|medical advice and does not substitute for the advice of your||
1847|006|Z|health care professional. Always ask your health care||
1847|007|Z|professional for complete information about this product and your||
1847|008|Z|specific health needs.||
1847|009|B|||
1847|010|T|SOTORASIB - ORAL||
1847|011|B|||
1847|012|C|COMMON BRAND NAME(S): Lumakras||
1847|013|B|||
1847|014|U|USES:  This medication is used to treat certain types of cancer||
1847|015|U|(such as lung, colorectal). It works by slowing or stopping the||
1847|016|U|growth of cancer cells.||
1847|017|B|||
1847|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1847|019|H|from your pharmacist before you start taking sotorasib and each||
1847|020|H|time you get a refill. If you have any questions, ask your doctor||
1847|021|H|or pharmacist.||
1847|022|H|   Take this medication by mouth with or without food as directed||
1847|023|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
1847|024|H|not chew, crush, or split the tablets.||
1847|025|H|   If you have trouble swallowing the tablet whole, place the||
1847|026|H|tablet into a cup with half a glass of non-carbonated,||
1847|027|H|room-temperature water (4 ounces/120 milliliters). Stir or swirl||
1847|028|H|the cup for about 3 minutes until the tablet breaks into small||
1847|029|H|pieces. The tablet will not completely dissolve. Do not crush the||
1847|030|H|tablet or heat the mixture. Drink all of the mixture, without||
1847|031|H|chewing, right away or within 2 hours. After drinking the||
1847|032|H|mixture, rinse the cup with another half a glass of water (4||
1847|033|H|ounces/120 milliliters) and drink the rinse water to make sure||
1847|034|H|you are getting all of the drug. If you are not drinking the||
1847|035|H|mixture right away, make sure to stir the mixture right before||
1847|036|H|drinking.||
1847|037|H|   The dosage is based on your medical condition and response to||
1847|038|H|treatment. Do not increase your dose or use this drug more often||
1847|039|H|or for longer than prescribed. Your condition will not improve||
1847|040|H|any faster, and your risk of side effects will increase.||
1847|041|H|   If you vomit after taking a dose, do not take another dose.||
1847|042|H|Take your next dose at your regular scheduled time.||
1847|043|H|   Use this medication regularly to get the most benefit from it.||
1847|044|H|To help you remember, take it at the same time each day.||
1847|045|H|   Medications that reduce stomach acid (such as antacids, proton||
1847|046|H|pump inhibitors/PPIs, H2 blockers) may make sotorasib work less||
1847|047|H|well. Do not take PPIs (such as lansoprazole, omeprazole) or H2||
1847|048|H|blockers (such as famotidine, nizatidine) while using this||
1847|049|H|medication. If you take antacids, take sotorasib 4 hours before||
1847|050|H|or 10 hours after taking the antacid.||
1847|051|B|||
1847|052|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea or constipation,||
1847|053|S|muscle/joint pain, or tiredness may occur. If any of these||
1847|054|S|effects last or get worse, tell your doctor or pharmacist||
1847|055|S|promptly.||
1847|056|S|   People using this medication may have serious side effects.||
1847|057|S|However, you have been prescribed this drug because your doctor||
1847|058|S|has judged that the benefit to you is greater than the risk of||
1847|059|S|side effects. Careful monitoring by your doctor may decrease your||
1847|060|S|risk.||
1847|061|S|   Tell your doctor right away if you have any serious side||
1847|062|S|effects, including: signs of liver disease (such as||
1847|063|S|nausea/vomiting that doesn't stop, loss of appetite,||
1847|064|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1847|065|S|swelling hands/ankles/feet.||
1847|066|S|   Sotorasib can cause severe (possibly fatal) lung problems.||
1847|067|S|Tell your doctor right away if you have any symptoms of lung||
1847|068|S|problems (such as fever, new or worsening cough/shortness of||
1847|069|S|breath).||
1847|070|S|   Sotorasib can commonly cause a rash that is usually not||
1847|071|S|serious. However, you may not be able to tell it apart from a||
1847|072|S|rare rash that could be a sign of a severe reaction. Get medical||
1847|073|S|help right away if you develop any rash.||
1847|074|S|   A very serious allergic reaction to this drug is rare.||
1847|075|S|However, get medical help right away if you notice any symptoms||
1847|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1847|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1847|078|S|breathing.||
1847|079|S|   This is not a complete list of possible side effects. If you||
1847|080|S|notice other effects not listed above, contact your doctor or||
1847|081|S|pharmacist.||
1847|082|S|   In the US -||
1847|083|S|   Call your doctor for medical advice about side effects. You||
1847|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1847|085|S|www.fda.gov/medwatch.||
1847|086|S|   In Canada - Call your doctor for medical advice about side||
1847|087|S|effects. You may report side effects to Health Canada at||
1847|088|S|1-866-234-2345.||
1847|089|B|||
1847|090|P|PRECAUTIONS:  Before taking sotorasib, tell your doctor or||
1847|091|P|pharmacist if you are allergic to it; or if you have any other||
1847|092|P|allergies. This product may contain inactive ingredients, which||
1847|093|P|can cause allergic reactions or other problems. Talk to your||
1847|094|P|pharmacist for more details.||
1847|095|P|   Before using this medication, tell your doctor or pharmacist||
1847|096|P|your medical history, especially of: liver problems.||
1847|097|P|   Before having surgery, tell your doctor or dentist about all||
1847|098|P|the products you use (including prescription drugs,||
1847|099|P|nonprescription drugs, and herbal products).||
1847|100|P|   During pregnancy, this medication should be used only when||
1847|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
1847|102|P|   It is unknown if this drug passes into breast milk. Because of||
1847|103|P|the possible risk to the infant, breastfeeding is not recommended||
1847|104|P|while using this drug and for 1 week after the last dose. Consult||
1847|105|P|your doctor before breastfeeding.||
1847|106|B|||
1847|107|I|DRUG INTERACTIONS:  See also How to Use section.||
1847|108|I|   Drug interactions may change how your medications work or||
1847|109|I|increase your risk for serious side effects. This document does||
1847|110|I|not contain all possible drug interactions. Keep a list of all||
1847|111|I|the products you use (including prescription/nonprescription||
1847|112|I|drugs and herbal products) and share it with your doctor and||
1847|113|I|pharmacist. Do not start, stop, or change the dosage of any||
1847|114|I|medicines without your doctor's approval.||
1847|115|I|   Other medications can affect the removal of sotorasib from||
1847|116|I|your body, which may affect how sotorasib works. Examples include||
1847|117|I|rifamycins (such as rifabutin), drugs used to treat seizures||
1847|118|I|(such as carbamazepine, phenytoin), among others.||
1847|119|I|   This medication can speed up the removal of other medications||
1847|120|I|from your body, which may affect how they work. Examples of||
1847|121|I|affected drugs include daridorexant, elacestrant, lonafarnib,||
1847|122|I|mavacamten, quizartinib, revumenib, among others.||
1847|123|I|   This medication may decrease the effectiveness of hormonal||
1847|124|I|birth control such as pills, patch, or ring. This could cause||
1847|125|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1847|126|I|use reliable backup birth control methods while using this||
1847|127|I|medication. Also tell your doctor if you have any new spotting or||
1847|128|I|breakthrough bleeding, because these may be signs that your birth||
1847|129|I|control is not working well.||
1847|130|B|||
1847|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1847|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1847|133|O|poison control center right away. US residents can call||
1847|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1847|135|B|||
1847|136|N|NOTES:  Do not share this medication with others.||
1847|137|N|   Lab and/or medical tests (such as liver function, complete||
1847|138|N|blood count, blood mineral levels) should be done before you||
1847|139|N|start taking this medication and while you are taking it. Keep||
1847|140|N|all medical and lab appointments. Consult your doctor for more||
1847|141|N|details.||
1847|142|B|||
1847|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1847|144|D|remember. If it is more than 6 hours after the missed dose, skip||
1847|145|D|the missed dose. Take your next dose at the regular time. Do not||
1847|146|D|double the dose to catch up.||
1847|147|B|||
1847|148|R|STORAGE:  Store at room temperature away from light and moisture.||
1847|149|R|Do not store in the bathroom. Keep all medications away from||
1847|150|R|children and pets.||
1847|151|R|   Do not flush medications down the toilet or pour them into a||
1847|152|R|drain unless instructed to do so. Properly discard this product||
1847|153|R|when it is expired or no longer needed. Consult your pharmacist||
1847|154|R|or local waste disposal company.||
1847|155|B|||
1847|156|A|Information last revised June 2025.||
1847|157|A|Copyright(c) 2025 First Databank, Inc.||
1847|158|B|||
1849|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1849|002|Z|does NOT have all possible information about this product. This||
1849|003|Z|information does not assure that this product is safe, effective,||
1849|004|Z|or appropriate for you. This information is not individual||
1849|005|Z|medical advice and does not substitute for the advice of your||
1849|006|Z|health care professional. Always ask your health care||
1849|007|Z|professional for complete information about this product and your||
1849|008|Z|specific health needs.||
1849|009|B|||
1849|010|T|BELIMUMAB - SUBCUTANEOUS INJECTION||
1849|011|F|(be-LIM-ue-mab)||
1849|012|B|||
1849|013|C|COMMON BRAND NAME(S): Benlysta||
1849|014|B|||
1849|015|U|USES:  This medication is used with other medications to treat||
1849|016|U|certain types of lupus. Belimumab belongs to a class of drugs||
1849|017|U|known as monoclonal antibodies. It works by decreasing the effect||
1849|018|U|of a certain protein that is increased in people with active||
1849|019|U|lupus. This may help decrease some of the symptoms of lupus.||
1849|020|B|||
1849|021|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1849|022|H|provided by your pharmacist before you start using belimumab and||
1849|023|H|each time you get a refill. Ask your health care professional how||
1849|024|H|to prepare and use this medication. If you have any questions,||
1849|025|H|ask your doctor or pharmacist.||
1849|026|H|   Inject this medication under the skin as directed by your||
1849|027|H|doctor, usually once a week or once every 2 weeks. The injection||
1849|028|H|is given in the thighs or abdomen (at least 2 inches from your||
1849|029|H|belly button). The dosage is based on your medical condition and||
1849|030|H|response to treatment. If you are switching from receiving this||
1849|031|H|medication by injection into a vein, be sure you learn how and||
1849|032|H|when to start using this form of belimumab.||
1849|033|H|   Take the medication out of the refrigerator 30 minutes before||
1849|034|H|you inject it to allow it to reach room temperature. Do not warm||
1849|035|H|up this medication any other way (for example, do not heat it in||
1849|036|H|the microwave, place it in hot water, or leave it in direct||
1849|037|H|sunlight). Do not shake the medication. Before using, check this||
1849|038|H|product for particles or discoloration. If either is present, do||
1849|039|H|not use the liquid. Before injecting each dose, clean the skin||
1849|040|H|you are going to inject into (the injection site) with rubbing||
1849|041|H|alcohol. Change the injection site each time to lessen injury||
1849|042|H|under the skin. Do not inject into skin that is tender, bruised,||
1849|043|H|red, or hard. To lessen bruising, do not rub the injection site||
1849|044|H|after a shot. Learn how to store and discard medical supplies||
1849|045|H|safely.||
1849|046|H|   Use this medication regularly to get the most benefit from it.||
1849|047|H|To help you remember, use it on the same day each week. Mark your||
1849|048|H|calendar with a reminder.||
1849|049|H|   Tell your doctor if your condition does not get better or if||
1849|050|H|it gets worse.||
1849|051|B|||
1849|052|S|SIDE EFFECTS:  Bruising, redness, itching, or pain at the||
1849|053|S|injection site may occur. Nausea, diarrhea, or trouble sleeping||
1849|054|S|may also occur. If any of these effects last or get worse, tell||
1849|055|S|your doctor or pharmacist promptly.||
1849|056|S|   Remember that this medication has been prescribed because your||
1849|057|S|doctor has judged that the benefit to you is greater than the||
1849|058|S|risk of side effects. Many people using this medication do not||
1849|059|S|have serious side effects.||
1849|060|S|   Tell your doctor right away if you have any serious side||
1849|061|S|effects, including: mental/mood changes (such as new/worsening||
1849|062|S|depression, thoughts of suicide).||
1849|063|S|   This medication may lower your ability to fight infections.||
1849|064|S|This may make you more likely to get a serious (rarely fatal)||
1849|065|S|infection or make any infection you have worse. Tell your doctor||
1849|066|S|right away if you have any signs of infection (such as sore||
1849|067|S|throat that doesn't go away, fever, chills).||
1849|068|S|   Very rarely, people using this medication have developed||
1849|069|S|cancers (including skin cancer). Tell your doctor right away if||
1849|070|S|you develop symptoms such as a new skin lesion or bump, change in||
1849|071|S|size or color of a mole, night sweats, swollen lymph nodes, or||
1849|072|S|unexplained weight loss.||
1849|073|S|   This medication may increase your risk of getting a rare but||
1849|074|S|very serious (possibly fatal) brain infection (progressive||
1849|075|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1849|076|S|if you have any of these side effects: clumsiness, loss of||
1849|077|S|coordination/balance, weakness, sudden change in your thinking||
1849|078|S|(such as confusion, difficulty concentrating, memory loss),||
1849|079|S|difficulty talking/walking, seizure, vision changes.||
1849|080|S|   Get medical help right away if you have any very serious side||
1849|081|S|effects, including: heart problems (such as chest/jaw/left arm||
1849|082|S|pain, shortness of breath, unusual sweating).||
1849|083|S|   A very serious allergic reaction to this drug is rare.||
1849|084|S|However, get medical help right away if you notice any symptoms||
1849|085|S|of a serious allergic reaction, including: rash, itching/swelling||
1849|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1849|087|S|breathing.||
1849|088|S|   This is not a complete list of possible side effects. If you||
1849|089|S|notice other effects not listed above, contact your doctor or||
1849|090|S|pharmacist.||
1849|091|S|   In the US -||
1849|092|S|   Call your doctor for medical advice about side effects. You||
1849|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1849|094|S|www.fda.gov/medwatch.||
1849|095|S|   In Canada - Call your doctor for medical advice about side||
1849|096|S|effects. You may report side effects to Health Canada at||
1849|097|S|1-866-234-2345.||
1849|098|B|||
1849|099|P|PRECAUTIONS:  Before using belimumab, tell your doctor or||
1849|100|P|pharmacist if you are allergic to it; or if you have any other||
1849|101|P|allergies. This product may contain inactive ingredients, which||
1849|102|P|can cause allergic reactions or other problems. Talk to your||
1849|103|P|pharmacist for more details.||
1849|104|P|   Before using this medication, tell your doctor or pharmacist||
1849|105|P|your medical history, especially of: current/recent/returning||
1849|106|P|infection, mental/mood problems (such as depression, thoughts of||
1849|107|P|suicide), cancer.||
1849|108|P|   Belimumab can make you more likely to get infections or may||
1849|109|P|make current infections worse. Stay away from anyone who has an||
1849|110|P|infection that may easily spread (such as chickenpox, COVID-19,||
1849|111|P|measles, flu). Talk to your doctor if you have been exposed to an||
1849|112|P|infection or for more details.||
1849|113|P|   Tell your health care professional that you are using||
1849|114|P|belimumab before having any immunizations/vaccinations. Avoid||
1849|115|P|contact with people who have recently received live vaccines||
1849|116|P|(such as flu vaccine inhaled through the nose).||
1849|117|P|   Before having surgery, tell your doctor or dentist about all||
1849|118|P|the products you use (including prescription drugs,||
1849|119|P|nonprescription drugs, and herbal products).||
1849|120|P|   During pregnancy, this medication should be used only when||
1849|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
1849|122|P|   This drug passes into breast milk. Consult your doctor before||
1849|123|P|breastfeeding.||
1849|124|B|||
1849|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1849|126|I|medications work or increase your risk for serious side effects.||
1849|127|I|This document does not contain all possible drug interactions.||
1849|128|I|Keep a list of all the products you use (including||
1849|129|I|prescription/nonprescription drugs and herbal products) and share||
1849|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
1849|131|I|the dosage of any medicines without your doctor's approval.||
1849|132|I|   Some products that may interact with this drug are: other||
1849|133|I|drugs that weaken the immune system/increase the risk of||
1849|134|I|infection (such as natalizumab, rituximab).||
1849|135|B|||
1849|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1849|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1849|138|O|poison control center right away. US residents can call||
1849|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1849|140|B|||
1849|141|N|NOTES:  Do not share this medication with others.||
1849|142|N|   Lab and/or medical tests may be done while you are using this||
1849|143|N|medication. Keep all medical and lab appointments.||
1849|144|B|||
1849|145|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1849|146|D|Use your next dose at the regular time or keep using once a week||
1849|147|D|based on the new day injected. If you are not sure when to inject||
1849|148|D|your dose, ask your doctor or pharmacist. Do not use 2 doses on||
1849|149|D|the same day to catch up.||
1849|150|B|||
1849|151|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1849|152|R|medication in the original carton to protect from light. This||
1849|153|R|medication may also be stored at room temperature if needed. If||
1849|154|R|the medication is stored at room temperature, discard after 12||
1849|155|R|hours. Discard any unused portion after use. Keep all medications||
1849|156|R|away from children and pets.||
1849|157|R|   Do not flush medications down the toilet or pour them into a||
1849|158|R|drain unless instructed to do so. Properly discard this product||
1849|159|R|when it is expired or no longer needed. Consult your pharmacist||
1849|160|R|or local waste disposal company.||
1849|161|B|||
1849|162|M|MEDICAL ALERT:  Your condition can cause complications in a||
1849|163|M|medical emergency. For information about enrolling in MedicAlert,||
1849|164|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1849|165|B|||
1849|166|A|Information last revised May 2025.||
1849|167|A|Copyright(c) 2025 First Databank, Inc.||
1849|168|B|||
1850|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1850|002|Z|does NOT have all possible information about this product. This||
1850|003|Z|information does not assure that this product is safe, effective,||
1850|004|Z|or appropriate for you. This information is not individual||
1850|005|Z|medical advice and does not substitute for the advice of your||
1850|006|Z|health care professional. Always ask your health care||
1850|007|Z|professional for complete information about this product and your||
1850|008|Z|specific health needs.||
1850|009|B|||
1850|010|T|METHYLPHENIDATE EXTENDED-RELEASE DISINTEGRATING - ORAL||
1850|011|F|(METH-il-FEN-i-date)||
1850|012|B|||
1850|013|C|COMMON BRAND NAME(S): Cotempla XR-ODT||
1850|014|B|||
1850|015|W|WARNING:  Misuse or abuse of methylphenidate can cause serious||
1850|016|W|(possibly fatal) heart and blood pressure problems.||
1850|017|W|   This medication can be habit-forming and people who have||
1850|018|W|mental/mood disorders or a substance use disorder (such as||
1850|019|W|overuse of or addiction to drugs/alcohol) should use it||
1850|020|W|cautiously. Before using this medication, tell your doctor if you||
1850|021|W|have a personal or family history of a substance use disorder. Do||
1850|022|W|not increase your dose, use it more often, or use it for a longer||
1850|023|W|time or in a different way than prescribed. Doing so may cause||
1850|024|W|the drug to work less well, or cause drug dependence or abnormal||
1850|025|W|thoughts/behavior.||
1850|026|W|   Your doctor may monitor you for a while after the medication||
1850|027|W|is stopped, especially if you have taken this drug for a long||
1850|028|W|time or in high doses. (See also How to Use section.)||
1850|029|B|||
1850|030|U|USES:  This medication is used to treat attention deficit||
1850|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
1850|032|U|of certain natural substances in the brain. Methylphenidate||
1850|033|U|belongs to a class of drugs known as stimulants. It can help||
1850|034|U|increase your ability to pay attention, stay focused on an||
1850|035|U|activity, and control behavior problems. It may also help you to||
1850|036|U|organize your tasks and improve listening skills.||
1850|037|B|||
1850|038|H|HOW TO USE:  Read the Medication Guide provided by your||
1850|039|H|pharmacist before you start taking methylphenidate and each time||
1850|040|H|you get a refill. If you have any questions, ask your doctor or||
1850|041|H|pharmacist.||
1850|042|H|   Take this medication by mouth as directed by your doctor,||
1850|043|H|usually once daily in the morning. You may take this medication||
1850|044|H|with or without food, but it is important to choose one way and||
1850|045|H|take this medication the same way with every dose. Taking this||
1850|046|H|medication late in the day may cause trouble sleeping (insomnia).||
1850|047|H|   Keep the medication in the original package until you are||
1850|048|H|ready to take a dose. Dry your hands before handling the||
1850|049|H|medication. Peel back the foil layer of the blister pack to||
1850|050|H|remove a tablet. Do not push the tablet through the foil because||
1850|051|H|it may get damaged. Place the tablet on your tongue, allow it to||
1850|052|H|dissolve, and swallow with your saliva. You do not need to take||
1850|053|H|this medication with water or other liquid. Do not crush or chew||
1850|054|H|the tablet.||
1850|055|H|   The dosage is based on your medical condition and response to||
1850|056|H|treatment. Your doctor may direct you to gradually increase or||
1850|057|H|decrease your dose. Also, if you have used it for a long time, do||
1850|058|H|not suddenly stop using this drug without consulting your doctor.||
1850|059|H|   Take this medication regularly to get the most benefit from||
1850|060|H|it. To help you remember, take it at the same time each day.||
1850|061|H|   If you suddenly stop using this medication, you may have||
1850|062|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
1850|063|H|other mental/mood changes). To help prevent withdrawal, your||
1850|064|H|doctor may lower your dose slowly. Withdrawal is more likely if||
1850|065|H|you have used methylphenidate for a long time or in high doses.||
1850|066|H|Tell your doctor or pharmacist right away if you have withdrawal.||
1850|067|H|   When this medication is used for a long time, it may not work||
1850|068|H|as well. Talk with your doctor if this medication stops working||
1850|069|H|well.||
1850|070|H|   Though it helps many people, this medication may sometimes||
1850|071|H|cause addiction. This risk may be higher if you have a substance||
1850|072|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1850|073|H|Take this medication exactly as prescribed to lower the risk of||
1850|074|H|addiction. Ask your doctor or pharmacist for more details.||
1850|075|H|   Tell your doctor if your condition does not get better or if||
1850|076|H|it gets worse.||
1850|077|B|||
1850|078|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
1850|079|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
1850|080|S|If any of these effects last or get worse, tell your doctor or||
1850|081|S|pharmacist promptly.||
1850|082|S|   Remember that this medication has been prescribed because your||
1850|083|S|doctor has judged that the benefit to you is greater than the||
1850|084|S|risk of side effects. Many people using this medication do not||
1850|085|S|have serious side effects.||
1850|086|S|   This medication may raise your blood pressure. Check your||
1850|087|S|blood pressure regularly and tell your doctor if the results are||
1850|088|S|high.||
1850|089|S|   Tell your doctor right away if you have any serious side||
1850|090|S|effects, including: signs of blood flow problems in the fingers||
1850|091|S|or toes (such as coldness, numbness, pain, or skin color||
1850|092|S|changes), unusual wounds on the fingers or toes,||
1850|093|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
1850|094|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
1850|095|S|thoughts of suicide), uncontrolled muscle movements (such as||
1850|096|S|twitching, shaking), sudden outbursts of words/sounds that are||
1850|097|S|hard to control, vision changes (such as blurred vision).||
1850|098|S|   Get medical help right away if you have any very serious side||
1850|099|S|effects, including: fainting, seizure, symptoms of a heart attack||
1850|100|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
1850|101|S|sweating), symptoms of a stroke (such as weakness on one side of||
1850|102|S|the body, trouble speaking, sudden vision changes, confusion).||
1850|103|S|   Rarely, males (including young boys and teens) may have a||
1850|104|S|painful or prolonged erection lasting 4 or more hours while using||
1850|105|S|this medication. Caregivers/parents should also be watchful for||
1850|106|S|this serious side effect in boys. If a painful or prolonged||
1850|107|S|erection occurs, stop using this drug and get medical help right||
1850|108|S|away, or permanent problems could occur. Ask your doctor or||
1850|109|S|pharmacist for more details.||
1850|110|S|   A very serious allergic reaction to this drug is rare.||
1850|111|S|However, get medical help right away if you notice any symptoms||
1850|112|S|of a serious allergic reaction, including: rash, itching/swelling||
1850|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1850|114|S|breathing.||
1850|115|S|   This is not a complete list of possible side effects. If you||
1850|116|S|notice other effects not listed above, contact your doctor or||
1850|117|S|pharmacist.||
1850|118|S|   In the US -||
1850|119|S|   Call your doctor for medical advice about side effects. You||
1850|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1850|121|S|www.fda.gov/medwatch.||
1850|122|S|   In Canada - Call your doctor for medical advice about side||
1850|123|S|effects. You may report side effects to Health Canada at||
1850|124|S|1-866-234-2345.||
1850|125|B|||
1850|126|P|PRECAUTIONS:  See also Warning section.||
1850|127|P|   Before taking methylphenidate, tell your doctor or pharmacist||
1850|128|P|if you are allergic to it; or to dexmethylphenidate; or if you||
1850|129|P|have any other allergies. This product may contain inactive||
1850|130|P|ingredients, which can cause allergic reactions or other||
1850|131|P|problems. Talk to your pharmacist for more details.||
1850|132|P|   Before using this medication, tell your doctor or pharmacist||
1850|133|P|your medical history, especially of: high blood pressure, blood||
1850|134|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
1850|135|P|problems (such as irregular heartbeat, heart failure, previous||
1850|136|P|heart attack, problems with heart structure), family history of||
1850|137|P|heart problems (such as sudden cardiac death, irregular||
1850|138|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
1850|139|P|agitation), personal/family history of mental/mood disorders||
1850|140|P|(such as bipolar disorder, depression, psychosis, suicidal||
1850|141|P|thoughts), personal/family history of uncontrolled muscle||
1850|142|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
1850|143|P|(hyperthyroidism), seizure disorder.||
1850|144|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1850|145|P|can make you more dizzy. Do not drive, use machinery, or do||
1850|146|P|anything that needs alertness until you can do it safely. Avoid||
1850|147|P|alcoholic beverages. Talk to your doctor if you are using||
1850|148|P|marijuana (cannabis).||
1850|149|P|   Before having surgery, tell your doctor or dentist about all||
1850|150|P|the products you use (including prescription drugs,||
1850|151|P|nonprescription drugs, and herbal products).||
1850|152|P|   Children (especially those younger than 6) may be more||
1850|153|P|sensitive to the side effects of this drug, especially weight||
1850|154|P|loss. If used for a long time, this drug may affect a child's||
1850|155|P|growth rate, weight, and final adult height. To reduce the risk,||
1850|156|P|the doctor may recommend briefly stopping the medication from||
1850|157|P|time to time. Check the child's weight and height regularly, and||
1850|158|P|consult your doctor or pharmacist for more details.||
1850|159|P|   During pregnancy, methylphenidate should be used only when||
1850|160|P|clearly needed. Discuss the risks and benefits with your doctor.||
1850|161|P|   This medication passes into breast milk. Consult your doctor||
1850|162|P|before breastfeeding.||
1850|163|B|||
1850|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1850|165|I|medications work or increase your risk for serious side effects.||
1850|166|I|This document does not contain all possible drug interactions.||
1850|167|I|Keep a list of all the products you use (including||
1850|168|I|prescription/nonprescription drugs and herbal products) and share||
1850|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
1850|170|I|the dosage of any medicines without your doctor's approval.||
1850|171|I|   Taking MAO inhibitors with this medication may cause a serious||
1850|172|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
1850|173|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
1850|174|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
1850|175|I|selegiline, tranylcypromine) during treatment with this||
1850|176|I|medication. Most MAO inhibitors should also not be taken for two||
1850|177|I|weeks before treatment with this medication. Ask your doctor when||
1850|178|I|to start or stop taking this medication.||
1850|179|I|   Avoid alcohol while using this medication because it may cause||
1850|180|I|the medication to be released too quickly and increase the risk||
1850|181|I|of side effects.||
1850|182|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
1850|183|I|use medications containing dexmethylphenidate while using||
1850|184|I|methylphenidate.||
1850|185|I|   This medication may interfere with certain medical/lab tests||
1850|186|I|(including brain scan for Parkinson's disease), possibly causing||
1850|187|I|false test results. Make sure lab personnel and all your doctors||
1850|188|I|know you use this drug.||
1850|189|B|||
1850|190|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1850|191|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1850|192|O|poison control center right away. US residents can call||
1850|193|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1850|194|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
1850|195|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
1850|196|O|loss of consciousness.||
1850|197|B|||
1850|198|N|NOTES:  Do not share this medication with others. Sharing it is||
1850|199|N|against the law.||
1850|200|N|   Lab and/or medical tests (such as blood pressure, complete||
1850|201|N|blood count, height/weight monitoring in children) may be done||
1850|202|N|while you are taking this medication. Keep all medical and lab||
1850|203|N|appointments.||
1850|204|N|   There are different brands and forms of this medication||
1850|205|N|available. Not all have the same effects. Do not change brands or||
1850|206|N|forms without consulting your doctor or pharmacist.||
1850|207|B|||
1850|208|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1850|209|D|remember. If it is near bedtime or near the time of the next||
1850|210|D|dose, skip the missed dose. Take your next dose at the regular||
1850|211|D|time. Do not double the dose to catch up.||
1850|212|B|||
1850|213|R|STORAGE:  Store at room temperature away from light and moisture.||
1850|214|R|Do not store in the bathroom. Keep all medications away from||
1850|215|R|children and pets.||
1850|216|R|   Do not flush medications down the toilet or pour them into a||
1850|217|R|drain unless instructed to do so. Properly discard this product||
1850|218|R|when it is expired or no longer needed. Consult your pharmacist||
1850|219|R|or local waste disposal company.||
1850|220|B|||
1850|221|A|Information last revised July 2025.||
1850|222|A|Copyright(c) 2025 First Databank, Inc.||
1850|223|B|||
1851|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1851|002|Z|does NOT have all possible information about this product. This||
1851|003|Z|information does not assure that this product is safe, effective,||
1851|004|Z|or appropriate for you. This information is not individual||
1851|005|Z|medical advice and does not substitute for the advice of your||
1851|006|Z|health care professional. Always ask your health care||
1851|007|Z|professional for complete information about this product and your||
1851|008|Z|specific health needs.||
1851|009|B|||
1851|010|T|GLECAPREVIR/PIBRENTASVIR - ORAL||
1851|011|F|(glek-A-pre-vir/pi-BRENT-as-vir)||
1851|012|B|||
1851|013|C|COMMON BRAND NAME(S): Mavyret||
1851|014|B|||
1851|015|W|WARNING:  Although this product is used to treat hepatitis C, it||
1851|016|W|may rarely cause serious liver problems. It may make other liver||
1851|017|W|problems (such as hepatitis B) get worse. Before starting this||
1851|018|W|product, tell your doctor if you have ever had hepatitis B or any||
1851|019|W|other liver problems. See also Precautions section. Tell your||
1851|020|W|doctor right away if you have new or worsening symptoms of liver||
1851|021|W|disease, such as nausea/vomiting that doesn't stop, loss of||
1851|022|W|appetite, stomach/abdominal pain, dark urine or yellowing||
1851|023|W|eyes/skin.||
1851|024|B|||
1851|025|U|USES:  This medication is a combination of glecaprevir and||
1851|026|U|pibrentasvir and is used to treat hepatitis C, a viral infection||
1851|027|U|of the liver. Glecaprevir and pibrentasvir work by reducing the||
1851|028|U|amount of hepatitis C virus in your body, which helps your immune||
1851|029|U|system fight the infection and may help your liver recover.||
1851|030|U|Long-term infection with hepatitis C can lead to serious liver||
1851|031|U|problems such as scarring (cirrhosis) or liver cancer.||
1851|032|U|   It is not known if this treatment can prevent you from passing||
1851|033|U|the virus to others. Do not share needles, and practice "safer||
1851|034|U|sex" (such as the use of latex condoms) to lower the risk of||
1851|035|U|passing the virus to others.||
1851|036|B|||
1851|037|H|HOW TO USE:  Read the Patient Information Leaflet and||
1851|038|H|Instructions for Use if available from your pharmacist before you||
1851|039|H|start taking this product and each time you get a refill. If you||
1851|040|H|have any questions, ask your doctor or pharmacist.||
1851|041|H|   Take this medication by mouth with food as directed by your||
1851|042|H|doctor, usually once every day. Children's dosage is based on||
1851|043|H|weight.||
1851|044|H|   If you are using the pellet form of this medication, first||
1851|045|H|place about 1 to 2 teaspoons of soft food in a container. Use||
1851|046|H|soft foods that will stick to a spoon (such as peanut butter,||
1851|047|H|chocolate hazelnut spread, cream cheese, thick jam, or Greek||
1851|048|H|yogurt). Do not use any foods that are solid, watery, heated, or||
1851|049|H|frozen. Gently shake the packet, then tap to make sure the||
1851|050|H|pellets fall to the bottom before opening. Cut open the packet(s)||
1851|051|H|and pour the dose into the container of soft food. Gently mix and||
1851|052|H|give all of the dose right away. The mixture should be taken||
1851|053|H|within 15 minutes without chewing or crushing. Chewing, crushing,||
1851|054|H|or waiting to give the dose may make this medication taste bitter||
1851|055|H|and not work as well.||
1851|056|H|   For the best effect, take glecaprevir/pibrentasvir at evenly||
1851|057|H|spaced times. To help you remember, take this medication at the||
1851|058|H|same time every day.||
1851|059|H|   The length of treatment is based on your medical condition and||
1851|060|H|other treatments you may have used before taking this medication.||
1851|061|H|Continue to take this product for the full length of time||
1851|062|H|prescribed, even if symptoms disappear after a short time.||
1851|063|H|Stopping the medication too early may result in a return of the||
1851|064|H|infection.||
1851|065|B|||
1851|066|S|SIDE EFFECTS:  See also Warning section.||
1851|067|S|   Tiredness, headache, or nausea may occur. If any of these||
1851|068|S|effects last or get worse, tell your doctor or pharmacist||
1851|069|S|promptly.||
1851|070|S|   Remember that this product has been prescribed because your||
1851|071|S|doctor has judged that the benefit to you is greater than the||
1851|072|S|risk of side effects. Many people using this product do not have||
1851|073|S|serious side effects.||
1851|074|S|   A very serious allergic reaction to this product is rare.||
1851|075|S|However, get medical help right away if you notice any symptoms||
1851|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1851|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1851|078|S|breathing.||
1851|079|S|   This is not a complete list of possible side effects. If you||
1851|080|S|notice other effects not listed above, contact your doctor or||
1851|081|S|pharmacist.||
1851|082|S|   In the US -||
1851|083|S|   Call your doctor for medical advice about side effects. You||
1851|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1851|085|S|www.fda.gov/medwatch.||
1851|086|S|   In Canada - Call your doctor for medical advice about side||
1851|087|S|effects. You may report side effects to Health Canada at||
1851|088|S|1-866-234-2345.||
1851|089|B|||
1851|090|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1851|091|P|pharmacist if you are allergic to glecaprevir or pibrentasvir; or||
1851|092|P|if you have any other allergies. This product may contain||
1851|093|P|inactive ingredients, which can cause allergic reactions or other||
1851|094|P|problems. Talk to your pharmacist for more details.||
1851|095|P|   Before using this product, tell your doctor or pharmacist your||
1851|096|P|medical history, especially of: other liver problems (such as||
1851|097|P|hepatitis B, liver cancer), overuse of or addiction to alcohol,||
1851|098|P|HIV infection, diabetes.||
1851|099|P|   If you have diabetes, your blood sugar may be lower with||
1851|100|P|hepatitis C treatment. This can increase your risk of low blood||
1851|101|P|sugar, so your doctor may adjust your diabetes treatment plan.||
1851|102|P|Tell your doctor right away if you have symptoms of low blood||
1851|103|P|sugar such as sudden sweating, shaking, fast heartbeat, hunger,||
1851|104|P|blurred vision, dizziness, or tingling hands/feet.||
1851|105|P|   Before having surgery, tell your doctor or dentist about all||
1851|106|P|the products you use (such as prescription drugs, nonprescription||
1851|107|P|drugs, and herbal products).||
1851|108|P|   Children may be more sensitive to the side effects of this||
1851|109|P|drug, especially vomiting.||
1851|110|P|   During pregnancy, this product should be used only when||
1851|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
1851|112|P|   It is unknown if the medications in this product pass into||
1851|113|P|breast milk. Consult your doctor before breastfeeding.||
1851|114|B|||
1851|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1851|116|I|medications work or increase your risk for serious side effects.||
1851|117|I|This document does not contain all possible drug interactions.||
1851|118|I|Keep a list of all the products you use (including||
1851|119|I|prescription/nonprescription drugs and herbal products) and share||
1851|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1851|121|I|the dosage of any medicines without your doctor's approval.||
1851|122|I|   This medication can slow down the removal of other medications||
1851|123|I|from your body, which may affect how they work. Examples of||
1851|124|I|affected drugs include certain "statin" cholesterol drugs (such||
1851|125|I|as atorvastatin, lovastatin, simvastatin), among others.||
1851|126|I|   Other medications can affect the removal of this product from||
1851|127|I|your body, which may affect how this product works. Examples||
1851|128|I|include cyclosporine, efavirenz, HIV protease inhibitors (such as||
1851|129|I|atazanavir, darunavir), rifampin, certain drugs used to treat||
1851|130|I|seizures (such as carbamazepine, phenobarbital, phenytoin), St.||
1851|131|I|John's wort, among others.||
1851|132|B|||
1851|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1851|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1851|135|O|poison control center right away. US residents can call||
1851|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1851|137|B|||
1851|138|N|NOTES:  Do not share this product with others.||
1851|139|N|   Lab tests (such as liver function, tests for hepatitis B and||
1851|140|N|C) should be done before you start using this medication, while||
1851|141|N|you are using it, and after completing treatment. Keep all||
1851|142|N|medical and lab appointments.||
1851|143|B|||
1851|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1851|145|D|remember. If it is within 6 hours of the next dose, skip the||
1851|146|D|missed dose. Take your next dose at the regular time. Do not||
1851|147|D|double the dose to catch up.||
1851|148|B|||
1851|149|R|STORAGE:  Store in the original package at room temperature away||
1851|150|R|from light and moisture. Do not open the packets until you are||
1851|151|R|ready to use the medication. Do not store in the bathroom. Keep||
1851|152|R|all medications away from children and pets.||
1851|153|R|   Do not flush medications down the toilet or pour them into a||
1851|154|R|drain unless instructed to do so. Properly discard this product||
1851|155|R|when it is expired or no longer needed. Consult your pharmacist||
1851|156|R|or local waste disposal company.||
1851|157|B|||
1851|158|A|Information last revised June 2025.||
1851|159|A|Copyright(c) 2025 First Databank, Inc.||
1851|160|B|||
1852|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1852|002|Z|does NOT have all possible information about this product. This||
1852|003|Z|information does not assure that this product is safe, effective,||
1852|004|Z|or appropriate for you. This information is not individual||
1852|005|Z|medical advice and does not substitute for the advice of your||
1852|006|Z|health care professional. Always ask your health care||
1852|007|Z|professional for complete information about this product and your||
1852|008|Z|specific health needs.||
1852|009|B|||
1852|010|T|FLUTICASONE POWDER - ORAL INHALATION||
1852|011|F|(floo-TIK-a-sone)||
1852|012|B|||
1852|013|C|COMMON BRAND NAME(S): ArmonAir Digihaler, ArmonAir RespiClick||
1852|014|B|||
1852|015|U|USES:  Fluticasone is used to control and prevent symptoms (such||
1852|016|U|as wheezing and shortness of breath) caused by asthma.||
1852|017|U|Controlling symptoms of asthma helps you maintain your normal||
1852|018|U|activities and decreases time lost from work or school.||
1852|019|U|Fluticasone belongs to a class of drugs known as corticosteroids.||
1852|020|U|It works by reducing swelling (inflammation) of the airways in||
1852|021|U|the lungs to make breathing easier.||
1852|022|U|   This medication must be used regularly to be effective. It||
1852|023|U|does not work right away and should not be used to relieve sudden||
1852|024|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
1852|025|U|inhaler (such as albuterol, also called salbutamol in some||
1852|026|U|countries) as prescribed.||
1852|027|B|||
1852|028|V|OTHER USES:  This section contains uses of this drug that are not||
1852|029|V|listed in the approved professional labeling for the drug but||
1852|030|V|that may be prescribed by your health care professional. Use this||
1852|031|V|drug for a condition that is listed in this section only if it||
1852|032|V|has been so prescribed by your health care professional.||
1852|033|V|   This drug may also be used to control symptoms (such as||
1852|034|V|wheezing and shortness of breath) caused by ongoing lung disease||
1852|035|V|(chronic obstructive pulmonary disease-COPD, which includes||
1852|036|V|chronic bronchitis and emphysema). It may also be used for a||
1852|037|V|certain esophagus problem (eosinophilic esophagitis).||
1852|038|B|||
1852|039|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1852|040|H|your pharmacist before you start using this medication and each||
1852|041|H|time you get a refill. Follow the product directions for the||
1852|042|H|proper use of this medication. If you have any questions, ask||
1852|043|H|your doctor or pharmacist.||
1852|044|H|   Make sure the cap is closed before you start using your||
1852|045|H|inhaler. Hold the inhaler upright and open the cap until it||
1852|046|H|"clicks." Inhale this medication by mouth as directed by your||
1852|047|H|doctor, usually twice daily (in the morning and evening, 12 hours||
1852|048|H|apart). Inhale each dose deeply to get the drug into your lungs.||
1852|049|H|You may or may not taste/feel the drug when you inhale. Either is||
1852|050|H|normal. Do not breathe out into the device. Close the cap firmly||
1852|051|H|after each use.||
1852|052|H|   Do not take the inhaler apart or wash the mouthpiece or any||
1852|053|H|part of the device. Do not open the cap unless you are ready for||
1852|054|H|your next dose.||
1852|055|H|   If you are using other inhalers at the same time, wait at||
1852|056|H|least one minute between the use of each medication, and use this||
1852|057|H|drug (the corticosteroid) last.||
1852|058|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
1852|059|H|from developing, gargle, rinse your mouth with water and spit out||
1852|060|H|after each use. Do not swallow the rinse water.||
1852|061|H|   The dosage is based on your medical condition and response to||
1852|062|H|treatment.||
1852|063|H|   Use this medication regularly to get the most benefit from it.||
1852|064|H|This medication works best if used at evenly spaced times. To||
1852|065|H|help you remember, use it at the same times each day. Do not||
1852|066|H|increase your dose, use this drug more often, or stop using it||
1852|067|H|without first consulting your doctor.||
1852|068|H|   If you are regularly taking a different corticosteroid by||
1852|069|H|mouth (such as prednisone), you should not stop taking it unless||
1852|070|H|directed by your doctor. Some conditions (such as asthma,||
1852|071|H|allergies) may become worse when the drug is suddenly stopped. If||
1852|072|H|you suddenly stop taking the drug, you may also have withdrawal||
1852|073|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
1852|074|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
1852|075|H|doctor may slowly lower the dose of your old medication after you||
1852|076|H|begin using fluticasone. Tell your doctor or pharmacist right||
1852|077|H|away if you have withdrawal. See also Precautions section.||
1852|078|H|   It may take 1 to 2 weeks or longer before you get the full||
1852|079|H|benefit of this drug. Tell your doctor if your symptoms do not||
1852|080|H|get better or if they get worse.||
1852|081|H|   Learn which of your inhalers you should use every day||
1852|082|H|(controller drugs) and which you should use if your breathing||
1852|083|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
1852|084|H|time what you should do if you have new or worsening cough or||
1852|085|H|shortness of breath, wheezing, increased sputum, worsening peak||
1852|086|H|flow meter readings, waking up at night with trouble breathing,||
1852|087|H|if you use your quick-relief inhaler more often (more than 2 days||
1852|088|H|a week), or if your quick-relief inhaler does not seem to be||
1852|089|H|working well. Learn when you can treat sudden breathing problems||
1852|090|H|by yourself and when you must get medical help right away.||
1852|091|B|||
1852|092|S|SIDE EFFECTS:  See also Precautions section.||
1852|093|S|   Dry/irritated throat, hoarseness, or coughing may occur as||
1852|094|S|your body adjusts to the medication. If any of these effects last||
1852|095|S|or get worse, tell your doctor or pharmacist promptly.||
1852|096|S|   Remember that this medication has been prescribed because your||
1852|097|S|doctor has judged that the benefit to you is greater than the||
1852|098|S|risk of side effects. Many people using this medication do not||
1852|099|S|have serious side effects.||
1852|100|S|   Tell your doctor right away if you have any serious side||
1852|101|S|effects, including: white patches in your mouth or on your||
1852|102|S|tongue, signs of infection (such as sore throat that doesn't go||
1852|103|S|away, fever, chills), mental/mood changes (such as depression,||
1852|104|S|mood swings, agitation), vision problems, increased||
1852|105|S|thirst/urination, easy bruising/bleeding, bone pain.||
1852|106|S|   Rarely, this medication may cause sudden severe||
1852|107|S|wheezing/trouble breathing right after you use it. If this||
1852|108|S|occurs, use your quick-relief inhaler and get medical help right||
1852|109|S|away.||
1852|110|S|   A very serious allergic reaction to this drug is rare.||
1852|111|S|However, get medical help right away if you notice any symptoms||
1852|112|S|of a serious allergic reaction, including: rash, itching/swelling||
1852|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1852|114|S|breathing.||
1852|115|S|   This is not a complete list of possible side effects. If you||
1852|116|S|notice other effects not listed above, contact your doctor or||
1852|117|S|pharmacist.||
1852|118|S|   In the US -||
1852|119|S|   Call your doctor for medical advice about side effects. You||
1852|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1852|121|S|www.fda.gov/medwatch.||
1852|122|S|   In Canada - Call your doctor for medical advice about side||
1852|123|S|effects. You may report side effects to Health Canada at||
1852|124|S|1-866-234-2345.||
1852|125|B|||
1852|126|P|PRECAUTIONS:  Before using fluticasone, tell your doctor or||
1852|127|P|pharmacist if you are allergic to it; or if you have any other||
1852|128|P|allergies. This product may contain inactive ingredients (such as||
1852|129|P|milk proteins), which can cause allergic reactions or other||
1852|130|P|problems. Talk to your pharmacist for more details.||
1852|131|P|   Before using this medication, tell your doctor or pharmacist||
1852|132|P|your medical history, especially of: current/past infections||
1852|133|P|(such as tuberculosis, herpes), bone loss (osteoporosis), eye||
1852|134|P|problems (such as cataracts, glaucoma), liver disease.||
1852|135|P|   If you have switched from a corticosteroid taken by mouth||
1852|136|P|(such as prednisone tablets) to this inhaler within the past 12||
1852|137|P|months, or if you have been using this product in||
1852|138|P|higher-than-usual doses for a long time, it may be more difficult||
1852|139|P|for your body to respond to physical stress. Before having||
1852|140|P|surgery or emergency treatment, or if you get a serious||
1852|141|P|illness/injury, tell your doctor or dentist that you are using||
1852|142|P|this medication or have used a corticosteroid taken by mouth||
1852|143|P|within the past 12 months. Tell your doctor right away if you||
1852|144|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
1852|145|P|card or medical ID bracelet that says you use (or have used)||
1852|146|P|corticosteroid medications.||
1852|147|P|   This medication may mask signs of infection. It can make you||
1852|148|P|more likely to get infections or may make current infections||
1852|149|P|worse. Stay away from anyone who has an infection that may easily||
1852|150|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1852|151|P|doctor if you have been exposed to an infection or for more||
1852|152|P|details.||
1852|153|P|   Before having surgery, tell your doctor or dentist about all||
1852|154|P|the products you use (including prescription drugs,||
1852|155|P|nonprescription drugs, and herbal products).||
1852|156|P|   This medication may temporarily slow down a child's growth if||
1852|157|P|used for a long time. However, poorly controlled asthma can also||
1852|158|P|slow down growth. See the doctor regularly so your child's height||
1852|159|P|can be checked.||
1852|160|P|   During pregnancy, this medication should be used only when||
1852|161|P|clearly needed. Discuss the risks and benefits with your doctor.||
1852|162|P|   It is unknown if this drug passes into breast milk. Consult||
1852|163|P|your doctor before breastfeeding.||
1852|164|B|||
1852|165|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1852|166|I|medications work or increase your risk for serious side effects.||
1852|167|I|This document does not contain all possible drug interactions.||
1852|168|I|Keep a list of all the products you use (including||
1852|169|I|prescription/nonprescription drugs and herbal products) and share||
1852|170|I|it with your doctor and pharmacist. Do not start, stop, or change||
1852|171|I|the dosage of any medicines without your doctor's approval.||
1852|172|I|   A product that may interact with this drug is: desmopressin.||
1852|173|I|   Other medications can affect the removal of fluticasone from||
1852|174|I|your body, which may affect how fluticasone works. Examples||
1852|175|I|include some azole antifungals (such as ketoconazole), HIV||
1852|176|I|protease inhibitors (such as lopinavir), ritonavir, among others.||
1852|177|B|||
1852|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1852|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1852|180|O|poison control center right away. US residents can call||
1852|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1852|182|B|||
1852|183|N|NOTES:  Do not share this medication with others.||
1852|184|N|   Lab and/or medical tests (such as cortisol levels, lung||
1852|185|N|function, eye exams, bone density tests) should be done while you||
1852|186|N|are using this medication. Keep all medical and lab appointments.||
1852|187|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
1852|188|N|mold that can worsen breathing problems. Because the flu virus||
1852|189|N|can also worsen breathing problems, ask your doctor or pharmacist||
1852|190|N|if you should have a flu shot every year.||
1852|191|N|   This medication may cause bone loss (osteoporosis) in adults||
1852|192|N|when used for a long time. Lifestyle changes that may help reduce||
1852|193|N|the risk of bone problems include doing weight-bearing exercise,||
1852|194|N|stopping smoking, limiting alcohol, and getting enough calcium||
1852|195|N|and vitamin D. Talk to your doctor for more details.||
1852|196|B|||
1852|197|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1852|198|D|If it is near the time of the next dose, skip the missed dose.||
1852|199|D|Use your next dose at the regular time. Do not double the dose to||
1852|200|D|catch up.||
1852|201|B|||
1852|202|R|STORAGE:  Store at room temperature away from moisture, heat, and||
1852|203|R|sunlight. Do not store in the bathroom. Do not open the original||
1852|204|R|foil package until you are ready to use the medication. Once the||
1852|205|R|foil package is opened, this medication expires after 30 days.||
1852|206|R|Keep all medications away from children and pets.||
1852|207|R|   Do not flush medications down the toilet or pour them into a||
1852|208|R|drain unless instructed to do so. Properly discard this product||
1852|209|R|when it is expired or no longer needed. Consult your pharmacist||
1852|210|R|or local waste disposal company.||
1852|211|B|||
1852|212|M|MEDICAL ALERT:  Your condition can cause complications in a||
1852|213|M|medical emergency. For information about enrolling in MedicAlert,||
1852|214|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1852|215|B|||
1852|216|A|Information last revised September 2025.||
1852|217|A|Copyright(c) 2025 First Databank, Inc.||
1852|218|B|||
1853|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1853|002|Z|does NOT have all possible information about this product. This||
1853|003|Z|information does not assure that this product is safe, effective,||
1853|004|Z|or appropriate for you. This information is not individual||
1853|005|Z|medical advice and does not substitute for the advice of your||
1853|006|Z|health care professional. Always ask your health care||
1853|007|Z|professional for complete information about this product and your||
1853|008|Z|specific health needs.||
1853|009|B|||
1853|010|T|ENASIDENIB - ORAL||
1853|011|F|(EN-a-SID-a-nib)||
1853|012|B|||
1853|013|C|COMMON BRAND NAME(S): Idhifa||
1853|014|B|||
1853|015|W|WARNING:  Enasidenib has rarely caused a serious (possibly fatal)||
1853|016|W|condition called differentiation syndrome. This condition may||
1853|017|W|happen anytime during the first 5 months of treatment. Get||
1853|018|W|medical help right away if you develop any signs of||
1853|019|W|differentiation syndrome, such as fever, cough, shortness of||
1853|020|W|breath, trouble breathing, bone pain, rapid weight gain, swelling||
1853|021|W|of arms/legs, swelling around the neck/underarm/groin areas||
1853|022|W|(swollen lymph nodes), dizziness/lightheadedness, fast heartbeat,||
1853|023|W|or chest pain.||
1853|024|B|||
1853|025|U|USES:  This medication is used to treat a certain type of blood||
1853|026|U|cell cancer (acute myeloid leukemia-AML). Enasidenib works by||
1853|027|U|helping your bone marrow grow normal blood cells so you will need||
1853|028|U|fewer blood transfusions.||
1853|029|U|   This drug has been withdrawn from the Canadian market due to||
1853|030|U|problems with effectiveness.||
1853|031|B|||
1853|032|H|HOW TO USE:  Read the Medication Guide provided by your||
1853|033|H|pharmacist before you start taking enasidenib and each time you||
1853|034|H|get a refill. If you have any questions, ask your doctor or||
1853|035|H|pharmacist.||
1853|036|H|   Take this medication by mouth with or without food as directed||
1853|037|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
1853|038|H|not crush or split the tablets.||
1853|039|H|   Take this medication with a full glass of water (8 ounces/240||
1853|040|H|milliliters) unless your doctor directs you otherwise.||
1853|041|H|   The dosage is based on your medical condition and response to||
1853|042|H|treatment.||
1853|043|H|   Take this medication regularly to get the most benefit from||
1853|044|H|it. To help you remember, take it at the same time each day.||
1853|045|H|   Do not increase your dose or use this drug more often or for||
1853|046|H|longer than prescribed. Your condition will not improve any||
1853|047|H|faster, and your risk of serious side effects will increase.||
1853|048|H|   If you vomit after taking a dose, take another dose as soon as||
1853|049|H|possible on the same day. Then take your next dose at the regular||
1853|050|H|time the next day. Do not double the dose to catch up.||
1853|051|B|||
1853|052|S|SIDE EFFECTS:  See also Warning section.||
1853|053|S|   Diarrhea, nausea, vomiting, change in taste, or loss of||
1853|054|S|appetite may occur. Nausea and vomiting can be severe. In some||
1853|055|S|cases, your doctor may prescribe medication to prevent or relieve||
1853|056|S|nausea and vomiting. Eating several small meals, not eating||
1853|057|S|before treatment, or limiting activity may help lessen some of||
1853|058|S|these effects. If any of these effects last or get worse, tell||
1853|059|S|your doctor or pharmacist promptly.||
1853|060|S|   Remember that this medication has been prescribed because your||
1853|061|S|doctor has judged that the benefit to you is greater than the||
1853|062|S|risk of side effects. Many people using this medication do not||
1853|063|S|have serious side effects.||
1853|064|S|   Enasidenib sometimes causes side effects due to the rapid||
1853|065|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1853|066|S|risk, your doctor may add a medication and tell you to drink||
1853|067|S|plenty of fluids. Tell your doctor right away if you have||
1853|068|S|symptoms such as: low back/side pain (flank pain), muscle||
1853|069|S|spasms/weakness.||
1853|070|S|   Get medical help right away if you have any very serious side||
1853|071|S|effects, including: signs of kidney problems (such as painful||
1853|072|S|urination, pink/bloody urine, change in the amount of urine),||
1853|073|S|yellowing eyes/skin.||
1853|074|S|   A very serious allergic reaction to this drug is rare.||
1853|075|S|However, get medical help right away if you notice any symptoms||
1853|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1853|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1853|078|S|breathing.||
1853|079|S|   This is not a complete list of possible side effects. If you||
1853|080|S|notice other effects not listed above, contact your doctor or||
1853|081|S|pharmacist.||
1853|082|S|   In the US -||
1853|083|S|   Call your doctor for medical advice about side effects. You||
1853|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1853|085|S|www.fda.gov/medwatch.||
1853|086|S|   In Canada - Call your doctor for medical advice about side||
1853|087|S|effects. You may report side effects to Health Canada at||
1853|088|S|1-866-234-2345.||
1853|089|B|||
1853|090|P|PRECAUTIONS:  Before taking enasidenib, tell your doctor or||
1853|091|P|pharmacist if you are allergic to it; or if you have any other||
1853|092|P|allergies. This product may contain inactive ingredients, which||
1853|093|P|can cause allergic reactions or other problems. Talk to your||
1853|094|P|pharmacist for more details.||
1853|095|P|   Before using this medication, tell your doctor or pharmacist||
1853|096|P|your medical history.||
1853|097|P|   Before having surgery, tell your doctor or dentist about all||
1853|098|P|the products you use (including prescription drugs,||
1853|099|P|nonprescription drugs, and herbal products).||
1853|100|P|   Tell your doctor if you are pregnant or plan to become||
1853|101|P|pregnant. You should not become pregnant while using enasidenib.||
1853|102|P|Enasidenib may harm an unborn baby. Your doctor should order a||
1853|103|P|pregnancy test before you start this medication. Men and women||
1853|104|P|using this medication should ask about reliable forms of birth||
1853|105|P|control during treatment and for 2 months after the last dose.||
1853|106|P|Women should also ask about using reliable backup birth control||
1853|107|P|methods (such as condoms, diaphragm with spermicide) if they are||
1853|108|P|using hormonal birth control (such as birth control pills). If||
1853|109|P|you or your partner becomes pregnant, talk to your doctor right||
1853|110|P|away about the risks and benefits of this medication.||
1853|111|P|   It is unknown if this drug passes into breast milk. Because of||
1853|112|P|the possible risk to the infant, breastfeeding is not recommended||
1853|113|P|while using this drug and for 2 months after the last dose.||
1853|114|P|Consult your doctor before breastfeeding.||
1853|115|B|||
1853|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1853|117|I|medications work or increase your risk for serious side effects.||
1853|118|I|This document does not contain all possible drug interactions.||
1853|119|I|Keep a list of all the products you use (including||
1853|120|I|prescription/nonprescription drugs and herbal products) and share||
1853|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
1853|122|I|the dosage of any medicines without your doctor's approval.||
1853|123|I|   This medication can slow down the removal of other medications||
1853|124|I|from your body, which may affect how they work. Examples of||
1853|125|I|affected drugs include alosetron, fezolinetant, tizanidine,||
1853|126|I|vorasidenib, among others.||
1853|127|B|||
1853|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1853|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1853|130|O|poison control center right away. US residents can call||
1853|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1853|132|B|||
1853|133|N|NOTES:  Do not share this medication with others.||
1853|134|N|   Lab tests (such as complete blood counts) should be done||
1853|135|N|before you start taking this medication and while you are taking||
1853|136|N|it. Keep all medical and lab appointments.||
1853|137|B|||
1853|138|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1853|139|D|remember. If it is near the time of the next dose, skip the||
1853|140|D|missed dose. Take your next dose at the regular time. Do not||
1853|141|D|double the dose to catch up.||
1853|142|B|||
1853|143|R|STORAGE:  Store in the original container at room temperature||
1853|144|R|away from light and moisture. Do not store in the bathroom. Keep||
1853|145|R|all medications away from children and pets.||
1853|146|R|   Do not flush medications down the toilet or pour them into a||
1853|147|R|drain unless instructed to do so. Properly discard this product||
1853|148|R|when it is expired or no longer needed. Consult your pharmacist||
1853|149|R|or local waste disposal company.||
1853|150|B|||
1853|151|A|Information last revised July 2025.||
1853|152|A|Copyright(c) 2025 First Databank, Inc.||
1853|153|B|||
1854|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1854|002|Z|does NOT have all possible information about this product. This||
1854|003|Z|information does not assure that this product is safe, effective,||
1854|004|Z|or appropriate for you. This information is not individual||
1854|005|Z|medical advice and does not substitute for the advice of your||
1854|006|Z|health care professional. Always ask your health care||
1854|007|Z|professional for complete information about this product and your||
1854|008|Z|specific health needs.||
1854|009|B|||
1854|010|T|DAUNORUBICIN/CYTARABINE LIPOSOME - INJECTION||
1854|011|F|(DAW-noe-ROO-bi-sin/sye-TAR-abeen)||
1854|012|B|||
1854|013|C|COMMON BRAND NAME(S): Vyxeos||
1854|014|B|||
1854|015|W|WARNING:  This medication is not given the same way as similar||
1854|016|W|products including daunorubicin, daunorubicin liposome,||
1854|017|W|cytarabine, or cytarabine liposome. Do not use any of these||
1854|018|W|similar products while using daunorubicin/cytarabine liposome||
1854|019|W|injection.||
1854|020|W|   This medication may rarely cause serious (rarely fatal) heart||
1854|021|W|problems (including heart failure). This effect may occur during||
1854|022|W|treatment or months to years after treatment is completed. The||
1854|023|W|risk of heart problems is increased if you have heart disease, or||
1854|024|W|have had radiation treatment to the chest area, or use/have used||
1854|025|W|drugs that can also cause heart problems. Tell your doctor right||
1854|026|W|away if you notice symptoms such as irregular heartbeat,||
1854|027|W|shortness of breath, swelling ankles/feet, unusual tiredness, or||
1854|028|W|unusual/sudden weight gain.||
1854|029|W|   This medication decreases bone marrow function, an effect that||
1854|030|W|may lead to a low number of blood cells such as red cells, white||
1854|031|W|cells, and platelets. This effect can cause anemia, decrease your||
1854|032|W|body's ability to fight an infection, or cause easy||
1854|033|W|bruising/bleeding. Tell your doctor right away if you develop any||
1854|034|W|of the following symptoms: unusual tiredness, pale skin, signs of||
1854|035|W|infection (such as sore throat that doesn't go away, fever,||
1854|036|W|chills), easy bruising/bleeding.||
1854|037|W|   This medication must be given only by injection into a vein.||
1854|038|W|It must not be given by injection into a muscle or under the||
1854|039|W|skin. If this medication accidentally leaks into the skin/muscle||
1854|040|W|around the injection site, it may cause severe damage. Tell your||
1854|041|W|doctor right away if you notice redness, pain, or swelling at or||
1854|042|W|near the injection site.||
1854|043|B|||
1854|044|U|USES:  This medication is a combination product of daunorubicin||
1854|045|U|and cytarabine liposome and is used to treat leukemia. It is a||
1854|046|U|chemotherapy drug that works by slowing or stopping the growth of||
1854|047|U|cancer cells.||
1854|048|B|||
1854|049|H|HOW TO USE:  This medication is given by injection into a vein as||
1854|050|H|directed by your doctor. It is given by a health care||
1854|051|H|professional, usually over 90 minutes. The dosage and treatment||
1854|052|H|schedule are based on your medical condition, body size, and||
1854|053|H|response to treatment.||
1854|054|H|   Drink plenty of fluids while using this medication unless||
1854|055|H|otherwise directed by your doctor. Doing so helps decrease the||
1854|056|H|risk of certain side effects (such as increased uric acid).||
1854|057|B|||
1854|058|S|SIDE EFFECTS:  See also Warning section.||
1854|059|S|   Nausea, vomiting, constipation, diarrhea, and loss of appetite||
1854|060|S|may occur. In some cases, your doctor may prescribe medication to||
1854|061|S|prevent or relieve nausea and vomiting. Eating several small||
1854|062|S|meals, not eating before treatment, or limiting activity may help||
1854|063|S|lessen some of these effects. If any of these effects last or get||
1854|064|S|worse, tell your doctor or pharmacist promptly.||
1854|065|S|   Pain or sores in the mouth and throat may occur. Brush your||
1854|066|S|teeth carefully/gently, avoid using mouthwash that contains||
1854|067|S|alcohol, and rinse your mouth often with cool water mixed with||
1854|068|S|baking soda or salt. It may also be best to eat soft, moist||
1854|069|S|foods.||
1854|070|S|   Temporary hair loss may occur. Normal hair growth should||
1854|071|S|return after treatment has ended.||
1854|072|S|   People using this medication may have serious side effects.||
1854|073|S|However, you have been prescribed this drug because your doctor||
1854|074|S|has judged that the benefit to you is greater than the risk of||
1854|075|S|side effects. Careful monitoring by your doctor may decrease your||
1854|076|S|risk.||
1854|077|S|   Tell your doctor right away if you have any serious side||
1854|078|S|effects, including: unusual bleeding/bruising (such as small red||
1854|079|S|spots on the skin, black/bloody stools, bloody urine, vomit that||
1854|080|S|looks like coffee grounds).||
1854|081|S|   A very serious allergic reaction to this drug is rare.||
1854|082|S|However, get medical help right away if you notice any symptoms||
1854|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1854|084|S|(especially of the face/tongue/throat), trouble breathing, severe||
1854|085|S|dizziness.||
1854|086|S|   This is not a complete list of possible side effects. If you||
1854|087|S|notice other effects not listed above, contact your doctor or||
1854|088|S|pharmacist.||
1854|089|S|   In the US -||
1854|090|S|   Call your doctor for medical advice about side effects. You||
1854|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1854|092|S|www.fda.gov/medwatch.||
1854|093|S|   In Canada - Call your doctor for medical advice about side||
1854|094|S|effects. You may report side effects to Health Canada at||
1854|095|S|1-866-234-2345.||
1854|096|B|||
1854|097|P|PRECAUTIONS:  See also Warning section.||
1854|098|P|   Before using this product, tell your doctor or pharmacist if||
1854|099|P|you are allergic to daunorubicin, daunorubicin liposome,||
1854|100|P|cytarabine, or cytarabine liposome; or if you have any other||
1854|101|P|allergies. This product may contain inactive ingredients, which||
1854|102|P|can cause allergic reactions or other problems. Talk to your||
1854|103|P|pharmacist for more details.||
1854|104|P|   Before using this medication, tell your doctor or pharmacist||
1854|105|P|your medical history, especially of: blood/bleeding problems||
1854|106|P|(such as anemia), gout, heart problems (such as heart failure,||
1854|107|P|irregular heartbeat), kidney disease, liver disease, radiation||
1854|108|P|treatment (especially to the chest area), Wilson's disease.||
1854|109|P|   This medication can make you more likely to get infections or||
1854|110|P|may make current infections worse. Stay away from anyone who has||
1854|111|P|an infection that may easily spread (such as chickenpox,||
1854|112|P|COVID-19, measles, flu). Talk to your doctor if you have been||
1854|113|P|exposed to an infection or for more details.||
1854|114|P|   Tell your health care professional that you are using this||
1854|115|P|medication before having any immunizations/vaccinations. Avoid||
1854|116|P|contact with people who have recently received live vaccines||
1854|117|P|(such as flu vaccine inhaled through the nose).||
1854|118|P|   To lower the chance of getting cut, bruised, or injured, use||
1854|119|P|caution with sharp objects like razors and nail cutters, and||
1854|120|P|avoid activities such as contact sports.||
1854|121|P|   This medication contains copper. Caution is advised if you||
1854|122|P|have any condition (such as Wilson's disease) that requires you||
1854|123|P|to limit/avoid copper. Talk to your doctor for details.||
1854|124|P|   Before having surgery, tell your doctor or dentist about all||
1854|125|P|the products you use (including prescription drugs,||
1854|126|P|nonprescription drugs, and herbal products).||
1854|127|P|   Children may be more sensitive to the side effects of this||
1854|128|P|drug, especially heart problems.||
1854|129|P|   Tell your doctor if you are pregnant or plan to become||
1854|130|P|pregnant. You should not become pregnant while using this||
1854|131|P|medication. Daunorubicin/cytarabine liposome may harm an unborn||
1854|132|P|baby. Men and women using this medication should ask about||
1854|133|P|reliable forms of birth control during treatment and for 6 weeks||
1854|134|P|after the last dose. If you or your partner becomes pregnant,||
1854|135|P|talk to your doctor right away about the risks and benefits of||
1854|136|P|this medication.||
1854|137|P|   It is unknown if this drug passes into breast milk. Because of||
1854|138|P|the possible risk to the infant, breastfeeding is not recommended||
1854|139|P|while using this drug and for 2 weeks after the last dose.||
1854|140|P|Consult your doctor before breastfeeding.||
1854|141|B|||
1854|142|I|DRUG INTERACTIONS:  See also Warning section.||
1854|143|I|   Drug interactions may change how your medications work or||
1854|144|I|increase your risk for serious side effects. This document does||
1854|145|I|not contain all possible drug interactions. Keep a list of all||
1854|146|I|the products you use (including prescription/nonprescription||
1854|147|I|drugs and herbal products) and share it with your doctor and||
1854|148|I|pharmacist. Do not start, stop, or change the dosage of any||
1854|149|I|medicines without your doctor's approval.||
1854|150|B|||
1854|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1854|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1854|153|O|poison control center right away. US residents can call||
1854|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1854|155|B|||
1854|156|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
1854|157|N|complete blood count, uric acid, EKG) should be done while you||
1854|158|N|are taking this medication. Keep all medical and lab||
1854|159|N|appointments. Consult your doctor for more details.||
1854|160|B|||
1854|161|D|MISSED DOSE:  It is important to get each dose of this medication||
1854|162|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1854|163|D|right away for a new dosing schedule.||
1854|164|B|||
1854|165|R|STORAGE:  Not applicable. This medication is given in a hospital||
1854|166|R|or clinic or doctor's office and will not be stored at home.||
1854|167|B|||
1854|168|M|MEDICAL ALERT:  Your condition can cause complications in a||
1854|169|M|medical emergency. For information about enrolling in MedicAlert,||
1854|170|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1854|171|B|||
1854|172|A|Information last revised May 2024.||
1854|173|A|Copyright(c) 2025 First Databank, Inc.||
1854|174|B|||
1855|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1855|002|Z|does NOT have all possible information about this product. This||
1855|003|Z|information does not assure that this product is safe, effective,||
1855|004|Z|or appropriate for you. This information is not individual||
1855|005|Z|medical advice and does not substitute for the advice of your||
1855|006|Z|health care professional. Always ask your health care||
1855|007|Z|professional for complete information about this product and your||
1855|008|Z|specific health needs.||
1855|009|B|||
1855|010|T|INOTUZUMAB OZOGAMICIN - INJECTION||
1855|011|F|(IN-oh-TOOZ-ue-mab OH-zoe-ga-MYE-sin)||
1855|012|B|||
1855|013|C|COMMON BRAND NAME(S): Besponsa||
1855|014|B|||
1855|015|W|WARNING:  This drug may cause serious (possibly fatal) liver||
1855|016|W|disease. The risk may be greater in older adults, people with||
1855|017|W|liver disease, people with stem cell transplant (before or after||
1855|018|W|treatment), people receiving certain medications to prepare for||
1855|019|W|stem cell transplant, or people who receive this medication for a||
1855|020|W|long period of time. Get medical help right away if you have any||
1855|021|W|symptoms of liver damage, such as nausea/vomiting that doesn't||
1855|022|W|stop, loss of appetite, severe stomach/abdominal pain, yellowing||
1855|023|W|eyes/skin, dark urine, swelling abdomen, rapid weight gain.||
1855|024|W|   In people who receive this medication and also have a stem||
1855|025|W|cell transplant, there may be an increased risk of death due to||
1855|026|W|other causes (such as infection, liver disease). Talk to your||
1855|027|W|doctor for more details.||
1855|028|B|||
1855|029|U|USES:  This medication is used to treat a certain type of cancer||
1855|030|U|(acute lymphoblastic leukemia-ALL). It works by slowing or||
1855|031|U|stopping the growth of cancer cells.||
1855|032|B|||
1855|033|H|HOW TO USE:  This medication is given by injection into a vein||
1855|034|H|over 1 hour as directed by your doctor. The dosage is based on||
1855|035|H|your medical condition, body size, and response to treatment.||
1855|036|H|This medication is usually given once a week for 3 weeks followed||
1855|037|H|by a 1-week rest period. The cycle is then repeated as directed||
1855|038|H|by your doctor. There may not be a rest period between the first||
1855|039|H|and second cycle.||
1855|040|H|   Infusion reactions may happen during the infusion of this||
1855|041|H|drug. Your doctor may prescribe other medications before each||
1855|042|H|treatment to help prevent these side effects. Tell your doctor||
1855|043|H|right away if you have any symptoms of infusion reactions such as||
1855|044|H|shortness of breath, chills, fever, or rash. Your doctor may give||
1855|045|H|you other medications to help with these side effects or may slow||
1855|046|H|down or stop your treatment for some time.||
1855|047|H|   Use this medication regularly to get the most benefit from it.||
1855|048|H|To help you remember, mark your calendar with a reminder.||
1855|049|B|||
1855|050|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1855|051|S|   Headache, nausea/vomiting, abdominal pain, diarrhea,||
1855|052|S|constipation, or mouth sores may occur. If any of these effects||
1855|053|S|last or get worse, tell your doctor or pharmacist promptly.||
1855|054|S|   People using this medication may have serious side effects.||
1855|055|S|However, you have been prescribed this drug because your doctor||
1855|056|S|has judged that the benefit to you is greater than the risk of||
1855|057|S|side effects. Careful monitoring by your doctor may decrease your||
1855|058|S|risk.||
1855|059|S|   This medication decreases bone marrow function, an effect that||
1855|060|S|may lead to a low number of blood cells such as red cells, white||
1855|061|S|cells, and platelets. This effect can cause anemia, decrease your||
1855|062|S|body's ability to fight an infection, or cause easy||
1855|063|S|bruising/bleeding. Tell your doctor right away if you develop any||
1855|064|S|of the following symptoms: unusual tiredness, pale skin, signs of||
1855|065|S|infection (such as sore throat that doesn't go away, fever,||
1855|066|S|chills), easy bruising/bleeding, black/bloody stools, vomit that||
1855|067|S|contains blood or looks like coffee grounds.||
1855|068|S|   Get medical help right away if you have any very serious side||
1855|069|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1855|070|S|fainting.||
1855|071|S|   A very serious allergic reaction to this drug is rare.||
1855|072|S|However, get medical help right away if you notice any symptoms||
1855|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1855|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1855|075|S|breathing.||
1855|076|S|   This is not a complete list of possible side effects. If you||
1855|077|S|notice other effects not listed above, contact your doctor or||
1855|078|S|pharmacist.||
1855|079|S|   In the US -||
1855|080|S|   Call your doctor for medical advice about side effects. You||
1855|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1855|082|S|www.fda.gov/medwatch.||
1855|083|S|   In Canada - Call your doctor for medical advice about side||
1855|084|S|effects. You may report side effects to Health Canada at||
1855|085|S|1-866-234-2345.||
1855|086|B|||
1855|087|P|PRECAUTIONS:  See also Warning section.||
1855|088|P|   Before using inotuzumab ozogamicin, tell your doctor or||
1855|089|P|pharmacist if you are allergic to it; or if you have any other||
1855|090|P|allergies. This product may contain inactive ingredients, which||
1855|091|P|can cause allergic reactions or other problems. Talk to your||
1855|092|P|pharmacist for more details.||
1855|093|P|   Before using this medication, tell your doctor or pharmacist||
1855|094|P|your medical history, especially of: recent/current infections,||
1855|095|P|liver disease.||
1855|096|P|   Inotuzumab ozogamicin may cause a condition that affects the||
1855|097|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
1855|098|P|serious (rarely fatal) fast/irregular heartbeat and other||
1855|099|P|symptoms (such as severe dizziness, fainting) that need medical||
1855|100|P|attention right away.||
1855|101|P|   The risk of QT prolongation may be increased if you have||
1855|102|P|certain medical conditions or are taking other drugs that may||
1855|103|P|cause QT prolongation. Before using inotuzumab ozogamicin, tell||
1855|104|P|your doctor or pharmacist of all the drugs you take and if you||
1855|105|P|have any of the following conditions: certain heart problems||
1855|106|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
1855|107|P|family history of certain heart problems (QT prolongation in the||
1855|108|P|EKG, sudden cardiac death).||
1855|109|P|   Low levels of potassium or magnesium in the blood may also||
1855|110|P|increase your risk of QT prolongation. This risk may increase if||
1855|111|P|you use certain drugs (such as diuretics/"water pills") or if you||
1855|112|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1855|113|P|Talk to your doctor about using inotuzumab ozogamicin safely.||
1855|114|P|   Before having surgery, tell your doctor or dentist about all||
1855|115|P|the products you use (including prescription drugs,||
1855|116|P|nonprescription drugs, and herbal products).||
1855|117|P|   Inotuzumab ozogamicin can make you more likely to get||
1855|118|P|infections or may make current infections worse. Stay away from||
1855|119|P|anyone who has an infection that may easily spread (such as||
1855|120|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
1855|121|P|have been exposed to an infection or for more details.||
1855|122|P|   Tell your health care professional that you are using||
1855|123|P|inotuzumab ozogamicin before having any||
1855|124|P|immunizations/vaccinations. Avoid contact with people who have||
1855|125|P|recently received live vaccines (such as flu vaccine inhaled||
1855|126|P|through the nose).||
1855|127|P|   To lower the chance of getting cut, bruised, or injured, use||
1855|128|P|caution with sharp objects like razors and nail cutters, and||
1855|129|P|avoid activities such as contact sports.||
1855|130|P|   Older adults may be more sensitive to the side effects of this||
1855|131|P|drug, especially QT prolongation (see above).||
1855|132|P|   Tell your doctor if you are pregnant or plan to become||
1855|133|P|pregnant. You should not become pregnant while using this||
1855|134|P|medication. Inotuzumab ozogamicin may harm an unborn baby. Your||
1855|135|P|doctor should order a pregnancy test before you start this||
1855|136|P|medication. Women using this medication should ask about reliable||
1855|137|P|forms of birth control during treatment and for 8 months after||
1855|138|P|the last dose. Men using this medication should ask about||
1855|139|P|reliable forms of birth control during treatment and for 5 months||
1855|140|P|after the last dose. If you or your partner becomes pregnant,||
1855|141|P|talk to your doctor right away about the risks and benefits of||
1855|142|P|this medication.||
1855|143|P|   It is unknown if this medication passes into breast milk.||
1855|144|P|Because of the possible risk to the infant, breastfeeding is not||
1855|145|P|recommended while using this medication and for 2 months after||
1855|146|P|the last dose. Consult your doctor before breastfeeding.||
1855|147|B|||
1855|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1855|149|I|medications work or increase your risk for serious side effects.||
1855|150|I|This document does not contain all possible drug interactions.||
1855|151|I|Keep a list of all the products you use (including||
1855|152|I|prescription/nonprescription drugs and herbal products) and share||
1855|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
1855|154|I|the dosage of any medicines without your doctor's approval.||
1855|155|B|||
1855|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1855|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1855|158|O|poison control center right away. US residents can call||
1855|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1855|160|B|||
1855|161|N|NOTES:  Do not share this medication with others.||
1855|162|N|   Lab and/or medical tests (such as complete blood count, liver||
1855|163|N|function) should be done while you are using this medication.||
1855|164|N|Keep all medical and lab appointments. Consult your doctor for||
1855|165|N|more details.||
1855|166|B|||
1855|167|D|MISSED DOSE:  It is important to get each dose of this medication||
1855|168|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1855|169|D|right away for a new dosing schedule.||
1855|170|B|||
1855|171|R|STORAGE:  Not applicable. This medication is given in a clinic or||
1855|172|R|doctor's office and will not be stored at home.||
1855|173|B|||
1855|174|M|MEDICAL ALERT:  Your condition can cause complications in a||
1855|175|M|medical emergency. For information about enrolling in MedicAlert,||
1855|176|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1855|177|B|||
1855|178|A|Information last revised October 2024.||
1855|179|A|Copyright(c) 2025 First Databank, Inc.||
1855|180|B|||
1856|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1856|002|Z|does NOT have all possible information about this product. This||
1856|003|Z|information does not assure that this product is safe, effective,||
1856|004|Z|or appropriate for you. This information is not individual||
1856|005|Z|medical advice and does not substitute for the advice of your||
1856|006|Z|health care professional. Always ask your health care||
1856|007|Z|professional for complete information about this product and your||
1856|008|Z|specific health needs.||
1856|009|B|||
1856|010|T|OLAPARIB - ORAL||
1856|011|F|(oh-LAP-a-rib)||
1856|012|B|||
1856|013|C|COMMON BRAND NAME(S): Lynparza||
1856|014|B|||
1856|015|U|USES:  This medication is used to treat certain cancers (such as||
1856|016|U|breast, ovarian, fallopian tube, pancreatic, peritoneal cancer,||
1856|017|U|prostate). Olaparib works by slowing or stopping the growth of||
1856|018|U|cancer cells.||
1856|019|B|||
1856|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1856|021|H|pharmacist before you start taking olaparib and each time you get||
1856|022|H|a refill. If you have any questions, ask your doctor or||
1856|023|H|pharmacist.||
1856|024|H|   Take this medication by mouth with or without food as directed||
1856|025|H|by your doctor, usually twice daily (about 12 hours apart).||
1856|026|H|Swallow the tablets whole. Do not chew, crush, dissolve, or split||
1856|027|H|the tablets.||
1856|028|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1856|029|H|using this medication unless your doctor or pharmacist says you||
1856|030|H|may do so safely. Also avoid eating Seville oranges (often found||
1856|031|H|in marmalade). Grapefruit and Seville oranges can increase the||
1856|032|H|chance of side effects with this medicine. Ask your doctor or||
1856|033|H|pharmacist for more details.||
1856|034|H|   The dosage is based on your medical condition and response to||
1856|035|H|treatment. Use this medication regularly to get the most benefit||
1856|036|H|from it. To help you remember, take it at the same times each||
1856|037|H|day.||
1856|038|H|   Do not increase your dose or use this drug more often or for||
1856|039|H|longer than prescribed. Your condition will not improve any||
1856|040|H|faster, and your risk of serious side effects will increase.||
1856|041|H|   Since this drug can be absorbed through the skin and lungs and||
1856|042|H|may harm an unborn baby, women who are pregnant or who may become||
1856|043|H|pregnant should not handle this medication or breathe the dust||
1856|044|H|from the tablets.||
1856|045|B|||
1856|046|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, dizziness,||
1856|047|S|change in the way food tastes, or tiredness may occur. Nausea and||
1856|048|S|vomiting can be severe. In some cases, your doctor may prescribe||
1856|049|S|medication to prevent or relieve nausea and vomiting. Eating||
1856|050|S|several small meals, not eating before treatment, or limiting||
1856|051|S|activity may help lessen some of these effects. If any of these||
1856|052|S|effects last or get worse, tell your doctor or pharmacist||
1856|053|S|promptly.||
1856|054|S|   Pain or sores in the mouth and throat may occur. Brush your||
1856|055|S|teeth carefully/gently, avoid using mouthwash that contains||
1856|056|S|alcohol, and rinse your mouth often with cool water mixed with||
1856|057|S|baking soda or salt. It may also be best to eat soft, moist||
1856|058|S|foods.||
1856|059|S|   People using this medication may have serious side effects.||
1856|060|S|However, you have been prescribed this drug because your doctor||
1856|061|S|has judged that the benefit to you is greater than the risk of||
1856|062|S|side effects. Careful monitoring by your doctor may decrease your||
1856|063|S|risk.||
1856|064|S|   Tell your doctor right away if you have any serious side||
1856|065|S|effects, including: signs of kidney problems (such as change in||
1856|066|S|the amount of urine), new/worsening shortness of breath, swelling||
1856|067|S|hands/ankles/feet.||
1856|068|S|    Olaparib has rarely caused very serious (possibly fatal)||
1856|069|S|liver disease. Tell your doctor right away if you develop||
1856|070|S|symptoms of liver disease, such as nausea/vomiting that doesn't||
1856|071|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
1856|072|S|eyes/skin, dark urine.||
1856|073|S|   This medication decreases bone marrow function, an effect that||
1856|074|S|may lead to a low number of blood cells such as red cells, white||
1856|075|S|cells, and platelets. This effect can cause anemia, decrease your||
1856|076|S|body's ability to fight an infection, or cause easy||
1856|077|S|bruising/bleeding. Rarely, these problems can also be symptoms of||
1856|078|S|very serious (possibly fatal) cancer of the bone marrow or blood||
1856|079|S|cells, especially if you have had radiation or chemotherapy||
1856|080|S|treatment. Your doctor will monitor your blood cell counts. Tell||
1856|081|S|your doctor right away if you develop any of the following||
1856|082|S|symptoms: signs of anemia (such as unusual tiredness, pale skin,||
1856|083|S|rapid breathing, fast heartbeat), signs of infection (such as||
1856|084|S|sore throat that doesn't go away, fever, chills), easy||
1856|085|S|bruising/bleeding (such as pink/bloody urine, black/bloody||
1856|086|S|stools), weakness, weight loss.||
1856|087|S|   This medication may rarely cause serious problems from blood||
1856|088|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1856|089|S|legs). You may be at increased risk for blood clots if you are||
1856|090|S|severely dehydrated, or have a history of blood clots, or if you||
1856|091|S|are immobile (such as on very long plane flights or being||
1856|092|S|bedridden). If you use estrogen-containing products, these may||
1856|093|S|also increase your risk. Before using this medication, if you||
1856|094|S|have any of these conditions report them to your doctor or||
1856|095|S|pharmacist. Get medical help right away if any of these side||
1856|096|S|effects occur: shortness of breath/rapid breathing,||
1856|097|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1856|098|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1856|099|S|sudden/severe headaches, trouble speaking, weakness on one side||
1856|100|S|of the body, sudden vision changes.||
1856|101|S|   A very serious allergic reaction to this drug is rare.||
1856|102|S|However, get medical help right away if you notice any symptoms||
1856|103|S|of a serious allergic reaction, including: rash, itching/swelling||
1856|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1856|105|S|breathing.||
1856|106|S|   This is not a complete list of possible side effects. If you||
1856|107|S|notice other effects not listed above, contact your doctor or||
1856|108|S|pharmacist.||
1856|109|S|   In the US -||
1856|110|S|   Call your doctor for medical advice about side effects. You||
1856|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1856|112|S|www.fda.gov/medwatch.||
1856|113|S|   In Canada - Call your doctor for medical advice about side||
1856|114|S|effects. You may report side effects to Health Canada at||
1856|115|S|1-866-234-2345.||
1856|116|B|||
1856|117|P|PRECAUTIONS:  Before taking olaparib, tell your doctor or||
1856|118|P|pharmacist if you are allergic to it; or if you have any other||
1856|119|P|allergies. This product may contain inactive ingredients, which||
1856|120|P|can cause allergic reactions or other problems. Talk to your||
1856|121|P|pharmacist for more details.||
1856|122|P|   Before using this medication, tell your doctor or pharmacist||
1856|123|P|your medical history, especially of: kidney problems, liver||
1856|124|P|problems, lung/breathing problems.||
1856|125|P|   Olaparib can make you more likely to get infections or may||
1856|126|P|make current infections worse. Stay away from anyone who has an||
1856|127|P|infection that may easily spread (such as chickenpox, COVID-19,||
1856|128|P|measles, flu). Talk to your doctor if you have been exposed to an||
1856|129|P|infection or for more details.||
1856|130|P|   Tell your health care professional that you are using olaparib||
1856|131|P|before having any immunizations/vaccinations. Avoid contact with||
1856|132|P|people who have recently received live vaccines (such as flu||
1856|133|P|vaccine inhaled through the nose).||
1856|134|P|   To lower the chance of getting cut, bruised, or injured, use||
1856|135|P|caution with sharp objects like razors and nail cutters, and||
1856|136|P|avoid activities such as contact sports.||
1856|137|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1856|138|P|can make you more dizzy. Do not drive, use machinery, or do||
1856|139|P|anything that needs alertness until you can do it safely. Limit||
1856|140|P|alcoholic beverages. Talk to your doctor if you are using||
1856|141|P|marijuana (cannabis).||
1856|142|P|   Before having surgery, tell your doctor or dentist about all||
1856|143|P|the products you use (including prescription drugs,||
1856|144|P|nonprescription drugs, and herbal products).||
1856|145|P|   Men should not donate sperm while using olaparib and for 3||
1856|146|P|months after stopping treatment.||
1856|147|P|   Tell your doctor if you are pregnant or plan to become||
1856|148|P|pregnant. You should not become pregnant while using olaparib.||
1856|149|P|Olaparib may harm an unborn baby. Your doctor should order a||
1856|150|P|pregnancy test before you start this medication. Women using this||
1856|151|P|medication should ask about reliable forms of birth control||
1856|152|P|during treatment and for at least 6 months after the last dose.||
1856|153|P|Men using this medication should ask about reliable forms of||
1856|154|P|birth control during treatment and for at least 3 months after||
1856|155|P|the last dose. If you become pregnant, talk to your doctor right||
1856|156|P|away about the risks and benefits of this medication.||
1856|157|P|   Since this drug can be absorbed through the skin and lungs and||
1856|158|P|may harm an unborn baby, women who are pregnant or who may become||
1856|159|P|pregnant should not handle this medication or breathe the dust||
1856|160|P|from the tablets.||
1856|161|P|   It is unknown if this medication passes into breast milk.||
1856|162|P|Because of the possible risk to the infant, breastfeeding is not||
1856|163|P|recommended while using this medication and for at least one||
1856|164|P|month after the last dose. Consult your doctor before||
1856|165|P|breastfeeding.||
1856|166|B|||
1856|167|I|DRUG INTERACTIONS:  See also How to Use section.||
1856|168|I|   Drug interactions may change how your medications work or||
1856|169|I|increase your risk for serious side effects. This document does||
1856|170|I|not contain all possible drug interactions. Keep a list of all||
1856|171|I|the products you use (including prescription/nonprescription||
1856|172|I|drugs and herbal products) and share it with your doctor and||
1856|173|I|pharmacist. Do not start, stop, or change the dosage of any||
1856|174|I|medicines without your doctor's approval.||
1856|175|I|   Other medications can affect the removal of olaparib from your||
1856|176|I|body, which may affect how olaparib works. Examples include||
1856|177|I|carbamazepine, phenytoin, rifamycins (such as rifampin), St.||
1856|178|I|John's wort, among others.||
1856|179|B|||
1856|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1856|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1856|182|O|poison control center right away. US residents can call||
1856|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1856|184|B|||
1856|185|N|NOTES:  Do not share this medication with others.||
1856|186|N|   Lab and/or medical tests (such as complete blood counts, liver||
1856|187|N|function) should be done before you start taking this medication||
1856|188|N|and while you are taking it. Keep all medical and lab||
1856|189|N|appointments. Consult your doctor for more details.||
1856|190|B|||
1856|191|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1856|192|D|remember. If it is near the time of the next dose, skip the||
1856|193|D|missed dose. Take your next dose at the regular time. Do not||
1856|194|D|double the dose to catch up.||
1856|195|B|||
1856|196|R|STORAGE:  Store at room temperature away from light and moisture.||
1856|197|R|Do not store in the bathroom. Keep all medications away from||
1856|198|R|children and pets.||
1856|199|R|   Do not flush medications down the toilet or pour them into a||
1856|200|R|drain unless instructed to do so. Properly discard this product||
1856|201|R|when it is expired or no longer needed. Consult your pharmacist||
1856|202|R|or local waste disposal company.||
1856|203|B|||
1856|204|M|MEDICAL ALERT:  Your condition can cause complications in a||
1856|205|M|medical emergency. For information about enrolling in MedicAlert,||
1856|206|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1856|207|B|||
1856|208|A|Information last revised July 2025.||
1856|209|A|Copyright(c) 2025 First Databank, Inc.||
1856|210|B|||
1857|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1857|002|Z|does NOT have all possible information about this product. This||
1857|003|Z|information does not assure that this product is safe, effective,||
1857|004|Z|or appropriate for you. This information is not individual||
1857|005|Z|medical advice and does not substitute for the advice of your||
1857|006|Z|health care professional. Always ask your health care||
1857|007|Z|professional for complete information about this product and your||
1857|008|Z|specific health needs.||
1857|009|B|||
1857|010|T|LEVOFLOXACIN - INHALATION||
1857|011|F|(LEE-voe-FLOX-a-sin)||
1857|012|B|||
1857|013|W|WARNING:  Quinolone antibiotics (including levofloxacin) may||
1857|014|W|cause serious and possibly permanent tendon damage (such as||
1857|015|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
1857|016|W|(peripheral neuropathy), and nervous system problems. Get medical||
1857|017|W|help right away if you have any of the following symptoms:||
1857|018|W|pain/numbness/burning/tingling/weakness in your||
1857|019|W|arms/hands/legs/feet, changes in how you sense||
1857|020|W|touch/pain/temperature/vibration/body position, severe/lasting||
1857|021|W|headache, vision changes, shaking (tremors), seizures,||
1857|022|W|mental/mood changes (such as agitation, anxiety, confusion,||
1857|023|W|hallucinations, depression, rare thoughts of suicide).||
1857|024|W|   Tendon damage may occur during or after treatment with this||
1857|025|W|medication. Stop exercising, rest, and get medical help right||
1857|026|W|away if you develop joint/muscle/tendon pain or swelling. Your||
1857|027|W|risk for tendon problems is greater if you are over 60 years of||
1857|028|W|age, if you are taking corticosteroids (such as prednisone), or||
1857|029|W|if you have a kidney, heart, or lung transplant.||
1857|030|W|   This medication may make a certain muscle condition||
1857|031|W|(myasthenia gravis) worse. Tell your doctor right away if you||
1857|032|W|have new or worsening muscle weakness (such as drooping eyelids,||
1857|033|W|unsteady walk) or trouble breathing.||
1857|034|W|   Discuss the risks and benefits with your doctor before using||
1857|035|W|this medication.||
1857|036|B|||
1857|037|U|USES:  This medication is used to treat people with a certain||
1857|038|U|inherited condition (cystic fibrosis) who have an ongoing lung||
1857|039|U|infection with a certain bacteria (Pseudomonas aeruginosa).||
1857|040|U|People with cystic fibrosis produce thick, sticky mucus that can||
1857|041|U|plug up the tubes, ducts and passageways in the lungs. This can||
1857|042|U|result in serious breathing problems and infections in the lungs.||
1857|043|U|   Levofloxacin belongs to a class of drugs known as quinolone||
1857|044|U|antibiotics. Levofloxacin inhalation solution works by stopping||
1857|045|U|the growth of a certain bacteria (Pseudomonas aeruginosa) that||
1857|046|U|commonly infects the lungs of people with cystic fibrosis. This||
1857|047|U|effect decreases lung infections and damage, and helps to improve||
1857|048|U|breathing.||
1857|049|U|   This antibiotic treats only bacterial infections. It will not||
1857|050|U|work for viral infections (such as common cold, flu). Using any||
1857|051|U|antibiotic when it is not needed can cause it to not work for||
1857|052|U|future infections.||
1857|053|B|||
1857|054|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1857|055|H|your pharmacist before you start using levofloxacin and each time||
1857|056|H|you get a refill. This medication is used with a special machine||
1857|057|H|called a nebulizer that changes the solution to a fine mist that||
1857|058|H|you inhale. Follow the illustrated directions for the proper use||
1857|059|H|of this medication and the nebulizer. If you have any questions,||
1857|060|H|ask your doctor, pharmacist, or respiratory therapist.||
1857|061|H|   Use this medication with the nebulizer as directed by your||
1857|062|H|doctor, usually every 12 hours. Each treatment lasts about 5||
1857|063|H|minutes. This medicine is usually used for 28 days in a row,||
1857|064|H|followed by 28 days without this medication, repeating the cycle||
1857|065|H|until your doctor directs you to stop.||
1857|066|H|   Each ampule of levofloxacin is for one-time use. Inspect each||
1857|067|H|ampule before use. Normal solution is slightly yellow. Discard||
1857|068|H|the ampule if the solution is cloudy or has particles in it, or||
1857|069|H|if it has expired. Use all of the contents of the ampule for each||
1857|070|H|dose. Do not mix levofloxacin with any other medicines in the||
1857|071|H|nebulizer.||
1857|072|H|   Drink plenty of fluids while using this medication unless||
1857|073|H|otherwise directed by your doctor.||
1857|074|H|   For the best effect, use this antibiotic at evenly spaced||
1857|075|H|times. To help you remember, use this medication at the same||
1857|076|H|times every day.||
1857|077|H|   Continue to use this medication until the full prescribed||
1857|078|H|amount is finished, even if symptoms disappear after a few days.||
1857|079|H|Stopping the medication too early may result in a return of the||
1857|080|H|infection.||
1857|081|H|   Tell your doctor if your condition gets worse.||
1857|082|B|||
1857|083|S|SIDE EFFECTS:  See also Warning section.||
1857|084|S|   Cough, metallic taste, dizziness, or lightheadedness may||
1857|085|S|occur. If any of these effects last or get worse, tell your||
1857|086|S|doctor or pharmacist promptly.||
1857|087|S|   Remember that this medication has been prescribed because your||
1857|088|S|doctor has judged that the benefit to you is greater than the||
1857|089|S|risk of side effects. Many people using this medication do not||
1857|090|S|have serious side effects.||
1857|091|S|   Tell your doctor right away if you have any serious side||
1857|092|S|effects, including: unusual bruising/bleeding, signs of kidney||
1857|093|S|problems (such as change in the amount of urine), signs of liver||
1857|094|S|problems (such as nausea/vomiting that doesn't stop, loss of||
1857|095|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1857|096|S|urine).||
1857|097|S|   Get medical help right away if you have any very serious side||
1857|098|S|effects, including: chest pain, severe dizziness, fainting,||
1857|099|S|fast/irregular heartbeat, signs of a tear/break in the main blood||
1857|100|S|vessel called the aorta (such as sudden/severe pain in the||
1857|101|S|stomach/chest/back, shortness of breath).||
1857|102|S|   This medication may rarely cause a severe intestinal condition||
1857|103|S|due to a bacteria called C. difficile. This condition may occur||
1857|104|S|during treatment or weeks to months after treatment has stopped.||
1857|105|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1857|106|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1857|107|S|stool.||
1857|108|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1857|109|S|products because they may make symptoms worse.||
1857|110|S|   Use of this medication for prolonged or repeated periods may||
1857|111|S|result in oral thrush or a new yeast infection. Contact your||
1857|112|S|doctor if you notice white patches in your mouth, a change in||
1857|113|S|vaginal discharge, or other new symptoms.||
1857|114|S|   A very serious allergic reaction to this drug is rare.||
1857|115|S|However, get medical help right away if you notice any symptoms||
1857|116|S|of a serious allergic reaction, including: rash, itching/swelling||
1857|117|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1857|118|S|breathing.||
1857|119|S|   This is not a complete list of possible side effects. If you||
1857|120|S|notice other effects not listed above, contact your doctor or||
1857|121|S|pharmacist.||
1857|122|S|   In the US -||
1857|123|S|   Call your doctor for medical advice about side effects. You||
1857|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1857|125|S|www.fda.gov/medwatch.||
1857|126|S|   In Canada - Call your doctor for medical advice about side||
1857|127|S|effects. You may report side effects to Health Canada at||
1857|128|S|1-866-234-2345.||
1857|129|B|||
1857|130|P|PRECAUTIONS:  Before using levofloxacin, tell your doctor or||
1857|131|P|pharmacist if you are allergic to it; or to other quinolone||
1857|132|P|antibiotics (such as ciprofloxacin, moxifloxacin, ofloxacin); or||
1857|133|P|if you have any other allergies. This product may contain||
1857|134|P|inactive ingredients, which can cause allergic reactions or other||
1857|135|P|problems. Talk to your pharmacist for more details.||
1857|136|P|   Before using this medication, tell your doctor or pharmacist||
1857|137|P|your medical history, especially of: diabetes, joint/tendon||
1857|138|P|problems (such as tendonitis, bursitis), kidney disease,||
1857|139|P|mental/mood disorders (such as depression), a certain muscle||
1857|140|P|condition (myasthenia gravis), nerve problems (such as peripheral||
1857|141|P|neuropathy), seizures, blood vessel problems (such as aneurysm or||
1857|142|P|blockage of the aorta or other blood vessels, hardening of the||
1857|143|P|arteries), high blood pressure, certain genetic conditions||
1857|144|P|(Marfan syndrome, Ehlers-Danlos syndrome).||
1857|145|P|   Levofloxacin may cause a condition that affects the heart||
1857|146|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1857|147|P|serious (rarely fatal) fast/irregular heartbeat and other||
1857|148|P|symptoms (such as severe dizziness, fainting) that need medical||
1857|149|P|attention right away.||
1857|150|P|   The risk of QT prolongation may be increased if you have||
1857|151|P|certain medical conditions or are taking other drugs that may||
1857|152|P|cause QT prolongation. Before using levofloxacin, tell your||
1857|153|P|doctor or pharmacist of all the drugs you take and if you have||
1857|154|P|any of the following conditions: certain heart problems (heart||
1857|155|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1857|156|P|history of certain heart problems (QT prolongation in the EKG,||
1857|157|P|sudden cardiac death).||
1857|158|P|   Low levels of potassium or magnesium in the blood may also||
1857|159|P|increase your risk of QT prolongation. This risk may increase if||
1857|160|P|you use certain drugs (such as diuretics/"water pills") or if you||
1857|161|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1857|162|P|Talk to your doctor about using levofloxacin safely.||
1857|163|P|   This medication may rarely cause serious changes in blood||
1857|164|P|sugar, especially if you have diabetes. Check your blood sugar||
1857|165|P|regularly as directed and share the results with your doctor.||
1857|166|P|Watch for symptoms of high blood sugar, such as increased||
1857|167|P|thirst/urination. Also watch for symptoms of low blood sugar such||
1857|168|P|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
1857|169|P|vision, dizziness, or tingling hands/feet. It is a good habit to||
1857|170|P|carry glucose tablets or gel to treat low blood sugar. If you||
1857|171|P|don't have these reliable forms of glucose, rapidly raise your||
1857|172|P|blood sugar by eating a quick source of sugar such as table||
1857|173|P|sugar, honey, or candy, or by drinking fruit juice or non-diet||
1857|174|P|soda. Tell your doctor right away about the reaction and the use||
1857|175|P|of this product. To help prevent low blood sugar, eat meals on a||
1857|176|P|regular schedule, and do not skip meals. Your doctor may need to||
1857|177|P|switch you to another antibiotic or adjust your diabetes||
1857|178|P|medications if any reaction occurs.||
1857|179|P|   This drug may make you dizzy or lightheaded. Alcohol or||
1857|180|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
1857|181|P|machinery, or do anything that needs alertness until you can do||
1857|182|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1857|183|P|are using marijuana (cannabis).||
1857|184|P|   This medication may make you more sensitive to the sun. Limit||
1857|185|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1857|186|P|sunscreen and wear protective clothing when outdoors. Tell your||
1857|187|P|doctor right away if you get sunburned or have skin||
1857|188|P|blisters/redness.||
1857|189|P|   Levofloxacin may cause live bacterial vaccines (such as||
1857|190|P|typhoid vaccine) to not work well. Tell your health care||
1857|191|P|professional that you are using levofloxacin before having any||
1857|192|P|immunizations/vaccinations.||
1857|193|P|   Before having surgery, tell your doctor or dentist about all||
1857|194|P|the products you use (including prescription drugs,||
1857|195|P|nonprescription drugs, and herbal products).||
1857|196|P|   Older adults may be at greater risk for tendon problems||
1857|197|P|(especially if they are also taking corticosteroids such as||
1857|198|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
1857|199|P|tear/break in the main blood vessel (aorta).||
1857|200|P|   During pregnancy, this medication should be used only when||
1857|201|P|clearly needed. Discuss the risks and benefits with your doctor.||
1857|202|P|   This drug passes into breast milk. Consult your doctor before||
1857|203|P|breastfeeding.||
1857|204|B|||
1857|205|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1857|206|I|medications work or increase your risk for serious side effects.||
1857|207|I|This document does not contain all possible drug interactions.||
1857|208|I|Keep a list of all the products you use (including||
1857|209|I|prescription/nonprescription drugs and herbal products) and share||
1857|210|I|it with your doctor and pharmacist. Do not start, stop, or change||
1857|211|I|the dosage of any medicines without your doctor's approval.||
1857|212|I|   Levofloxacin is very similar to ofloxacin. Do not use||
1857|213|I|medications containing ofloxacin while using levofloxacin.||
1857|214|I|   This medication may interfere with certain lab tests (such as||
1857|215|I|urine screening for opiates), possibly causing false test||
1857|216|I|results. Make sure lab personnel and all your doctors know you||
1857|217|I|use this drug.||
1857|218|B|||
1857|219|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1857|220|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1857|221|O|poison control center right away. US residents can call||
1857|222|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1857|223|O|Symptoms of overdose may include: severe dizziness.||
1857|224|B|||
1857|225|N|NOTES:  Do not share this medication with others.||
1857|226|N|   This medication has been prescribed for your current condition||
1857|227|N|only. Do not use it later for another infection unless your||
1857|228|N|doctor tells you to.||
1857|229|N|   Lab tests (such as breathing tests, kidney function, complete||
1857|230|N|blood count, blood sugar, cultures) may be done before you start||
1857|231|N|using this medication and while you are using it. Keep all||
1857|232|N|medical and lab appointments.||
1857|233|B|||
1857|234|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1857|235|D|If it is near the time of the next dose, skip the missed dose.||
1857|236|D|Use your next dose at the regular time. Do not double the dose to||
1857|237|D|catch up.||
1857|238|B|||
1857|239|R|STORAGE:  Store at room temperature away from light. Keep the||
1857|240|R|ampules in the original package until ready to use. Once the||
1857|241|R|package is been opened, the ampules expire after 4 days. Once an||
1857|242|R|ampule is opened, use the ampule right away. Keep all medications||
1857|243|R|away from children and pets.||
1857|244|R|   Do not flush medications down the toilet or pour them into a||
1857|245|R|drain unless instructed to do so. Properly discard this product||
1857|246|R|when it is expired or no longer needed. Consult your pharmacist||
1857|247|R|or local waste disposal company.||
1857|248|B|||
1857|249|A|Information last revised July 2024.||
1857|250|A|Copyright(c) 2025 First Databank, Inc.||
1857|251|B|||
1858|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1858|002|Z|does NOT have all possible information about this product. This||
1858|003|Z|information does not assure that this product is safe, effective,||
1858|004|Z|or appropriate for you. This information is not individual||
1858|005|Z|medical advice and does not substitute for the advice of your||
1858|006|Z|health care professional. Always ask your health care||
1858|007|Z|professional for complete information about this product and your||
1858|008|Z|specific health needs.||
1858|009|B|||
1858|010|T|CICLOPIROX 1.5% SHAMPOO - TOPICAL||
1858|011|F|(SYE-kloe-PIR-ox)||
1858|012|B|||
1858|013|U|USES:  This medication is used to prevent or treat a certain||
1858|014|U|scalp condition (seborrheic dermatitis, also known as dandruff).||
1858|015|U|Ciclopirox is an antifungal drug that works by stopping the||
1858|016|U|growth of fungus.||
1858|017|B|||
1858|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1858|019|H|from your pharmacist before you start using ciclopirox shampoo||
1858|020|H|and each time you get a refill. If you have any questions, ask||
1858|021|H|your doctor or pharmacist.||
1858|022|H|   This medication is for use on the scalp. Apply only to the||
1858|023|H|scalp and areas next to the hairline. Avoid getting this||
1858|024|H|medication in the eyes, nose, or mouth. If you accidentally get||
1858|025|H|medication in these areas, rinse well with plenty of water.||
1858|026|H|   Use this medication as directed by your doctor, usually 2 or 3||
1858|027|H|times a week. Wet the scalp with water, then apply enough shampoo||
1858|028|H|to make lather. Massage the scalp well with your fingertips.||
1858|029|H|Leave the shampoo on for 2 to 3 minutes. Rinse well and apply a||
1858|030|H|second time, repeating these steps.||
1858|031|H|   Use this medication regularly to get the most benefit from it.||
1858|032|H|   Tell your doctor if your condition does not get better or if||
1858|033|H|it gets worse.||
1858|034|B|||
1858|035|S|SIDE EFFECTS:  Burning, redness, or itching at the application||
1858|036|S|site may occur. If any of these effects last or get worse, tell||
1858|037|S|your doctor or pharmacist promptly.||
1858|038|S|   Hair loss or changes to the feel of your hair may occur, but||
1858|039|S|these can also be symptoms of seborrheic dermatitis. People with||
1858|040|S|grey, white, or dyed hair may notice changes in hair color.||
1858|041|S|   Remember that this medication has been prescribed because your||
1858|042|S|doctor has judged that the benefit to you is greater than the||
1858|043|S|risk of side effects. Many people using this medication do not||
1858|044|S|have serious side effects.||
1858|045|S|   Tell your doctor right away if you have any serious side||
1858|046|S|effects, including: blistering/swelling/oozing at the application||
1858|047|S|site.||
1858|048|S|   A very serious allergic reaction to this drug is rare.||
1858|049|S|However, get medical help right away if you notice any symptoms||
1858|050|S|of a serious allergic reaction, including: rash, itching/swelling||
1858|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1858|052|S|breathing.||
1858|053|S|   This is not a complete list of possible side effects. If you||
1858|054|S|notice other effects not listed above, contact your doctor or||
1858|055|S|pharmacist.||
1858|056|S|   In the US -||
1858|057|S|   Call your doctor for medical advice about side effects. You||
1858|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1858|059|S|www.fda.gov/medwatch.||
1858|060|S|   In Canada - Call your doctor for medical advice about side||
1858|061|S|effects. You may report side effects to Health Canada at||
1858|062|S|1-866-234-2345.||
1858|063|B|||
1858|064|P|PRECAUTIONS:  Before using ciclopirox, tell your doctor or||
1858|065|P|pharmacist if you are allergic to it; or if you have any other||
1858|066|P|allergies. This product may contain inactive ingredients, which||
1858|067|P|can cause allergic reactions or other problems. Talk to your||
1858|068|P|pharmacist for more details.||
1858|069|P|   Before using this medication, tell your doctor or pharmacist||
1858|070|P|your medical history.||
1858|071|P|   Before having surgery, tell your doctor or dentist about all||
1858|072|P|the products you use (including prescription drugs,||
1858|073|P|nonprescription drugs, and herbal products).||
1858|074|P|   Tell your doctor if you are pregnant before using this||
1858|075|P|medication.||
1858|076|P|   It is unknown if this medication passes into breast milk.||
1858|077|P|Consult your doctor before breastfeeding.||
1858|078|B|||
1858|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1858|080|I|medications work or increase your risk for serious side effects.||
1858|081|I|This document does not contain all possible drug interactions.||
1858|082|I|Keep a list of all the products you use (including||
1858|083|I|prescription/nonprescription drugs and herbal products) and share||
1858|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
1858|085|I|the dosage of any medicines without your doctor's approval.||
1858|086|B|||
1858|087|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1858|088|O|has overdosed and has serious symptoms such as passing out or||
1858|089|O|trouble breathing, call 911. Otherwise, call a poison control||
1858|090|O|center right away. US residents can call 1-800-222-1222. Canada||
1858|091|O|residents can call 1-844-764-7669.||
1858|092|B|||
1858|093|N|NOTES:  Do not share this medication with others.||
1858|094|N|   This medication has been prescribed for your current condition||
1858|095|N|only. Do not use it later for another skin condition unless your||
1858|096|N|doctor tells you to. A different medication may be needed.||
1858|097|B|||
1858|098|D|MISSED DOSE:  If you forget to shampoo your hair with ciclopirox||
1858|099|D|on a given day, wash your hair with it the next day.||
1858|100|B|||
1858|101|R|STORAGE:  Store in the refrigerator or at room temperature. Do||
1858|102|R|not freeze. Keep all medications away from children and pets.||
1858|103|R|   Do not flush medications down the toilet or pour them into a||
1858|104|R|drain unless instructed to do so. Properly discard this product||
1858|105|R|when it is expired or no longer needed. Consult your pharmacist||
1858|106|R|or local waste disposal company.||
1858|107|B|||
1858|108|A|Information last revised May 2024.||
1858|109|A|Copyright(c) 2025 First Databank, Inc.||
1858|110|B|||
1859|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1859|002|Z|does NOT have all possible information about this product. This||
1859|003|Z|information does not assure that this product is safe, effective,||
1859|004|Z|or appropriate for you. This information is not individual||
1859|005|Z|medical advice and does not substitute for the advice of your||
1859|006|Z|health care professional. Always ask your health care||
1859|007|Z|professional for complete information about this product and your||
1859|008|Z|specific health needs.||
1859|009|B|||
1859|010|T|PROPIVERINE EXTENDED-RELEASE - ORAL||
1859|011|B|||
1859|012|U|USES:  This medication is used to treat an overactive bladder.||
1859|013|U|Propiverine belongs to a class of drugs known as antispasmodics.||
1859|014|U|It works by relaxing the bladder muscles to help improve your||
1859|015|U|control of urination. This effect helps reduce feelings of||
1859|016|U|needing to urinate right away, urinating very often, or being||
1859|017|U|unable to hold your urine.||
1859|018|B|||
1859|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1859|020|H|from your pharmacist before you start taking propiverine and each||
1859|021|H|time you get a refill. If you have any questions, ask your doctor||
1859|022|H|or pharmacist.||
1859|023|H|   Take this medication by mouth with or without food as directed||
1859|024|H|by your doctor, usually once a day. Swallow the capsules whole.||
1859|025|H|Do not crush or chew the capsules. Doing so can release all of||
1859|026|H|the drug at once, increasing the risk of side effects.||
1859|027|H|   Use this medication regularly to get the most benefit from it.||
1859|028|H|To help you remember, take it at the same time each day. The||
1859|029|H|dosage is based on your medical condition, response to treatment,||
1859|030|H|and other medications you may be taking. Be sure to tell your||
1859|031|H|doctor and pharmacist about all the products you use (including||
1859|032|H|prescription drugs, nonprescription drugs, and herbal products).||
1859|033|H|Ask your doctor or pharmacist for more details.||
1859|034|H|   Tell your doctor if your condition does not get better or if||
1859|035|H|it gets worse.||
1859|036|B|||
1859|037|S|SIDE EFFECTS:  Dry mouth, dry eyes, headache, constipation,||
1859|038|S|stomach upset/pain, dizziness, drowsiness, tiredness, or blurred||
1859|039|S|vision may occur. If any of these effects last or get worse, tell||
1859|040|S|your doctor or pharmacist promptly.||
1859|041|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
1859|042|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1859|043|S|substitute.||
1859|044|S|   To prevent constipation, eat dietary fiber, drink enough||
1859|045|S|water, and exercise. You may also need to take a laxative. Ask||
1859|046|S|your pharmacist which type of laxative is right for you.||
1859|047|S|   Remember that this medication has been prescribed because your||
1859|048|S|doctor has judged that the benefit to you is greater than the||
1859|049|S|risk of side effects. Many people using this medication do not||
1859|050|S|have serious side effects.||
1859|051|S|   Tell your doctor right away if you have any serious side||
1859|052|S|effects, including: vision changes, severe stomach/abdominal||
1859|053|S|pain, trouble urinating, signs of kidney infection (such as||
1859|054|S|burning/painful urination, lower back pain, fever).||
1859|055|S|   Get medical help right away if you have any very serious side||
1859|056|S|effects, including: fast/slow/irregular heartbeat, severe||
1859|057|S|dizziness, fainting.||
1859|058|S|   A very serious allergic reaction to this drug is rare.||
1859|059|S|However, get medical help right away if you notice any symptoms||
1859|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1859|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1859|062|S|breathing.||
1859|063|S|   This is not a complete list of possible side effects. If you||
1859|064|S|notice other effects not listed above, contact your doctor or||
1859|065|S|pharmacist.||
1859|066|S|   In the US -||
1859|067|S|   Call your doctor for medical advice about side effects. You||
1859|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1859|069|S|www.fda.gov/medwatch.||
1859|070|S|   In Canada - Call your doctor for medical advice about side||
1859|071|S|effects. You may report side effects to Health Canada at||
1859|072|S|1-866-234-2345.||
1859|073|B|||
1859|074|P|PRECAUTIONS:  Before taking propiverine, tell your doctor or||
1859|075|P|pharmacist if you are allergic to it; or if you have any other||
1859|076|P|allergies. This product may contain inactive ingredients, which||
1859|077|P|can cause allergic reactions or other problems. Talk to your||
1859|078|P|pharmacist for more details.||
1859|079|P|   Before using this medication, tell your doctor or pharmacist||
1859|080|P|your medical history, especially of: problems emptying your||
1859|081|P|bladder (urinary retention, bladder outflow obstruction),||
1859|082|P|blockage of stomach/intestines (gastric retention), glaucoma,||
1859|083|P|stomach/intestinal disease (such as ulcerative colitis, slowed||
1859|084|P|movement of stomach/intestines), severe constipation, kidney||
1859|085|P|disease, liver disease, a certain muscle disease (myasthenia||
1859|086|P|gravis).||
1859|087|P|   Propiverine may cause a condition that affects the heart||
1859|088|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1859|089|P|serious (rarely fatal) fast/irregular heartbeat and other||
1859|090|P|symptoms (such as severe dizziness, fainting) that need medical||
1859|091|P|attention right away.||
1859|092|P|   The risk of QT prolongation may be increased if you have||
1859|093|P|certain medical conditions or are taking other drugs that may||
1859|094|P|cause QT prolongation. Before using propiverine, tell your doctor||
1859|095|P|or pharmacist of all the drugs you take and if you have any of||
1859|096|P|the following conditions: certain heart problems (heart failure,||
1859|097|P|slow heartbeat, QT prolongation in the EKG), family history of||
1859|098|P|certain heart problems (QT prolongation in the EKG, sudden||
1859|099|P|cardiac death).||
1859|100|P|   Low levels of potassium or magnesium in the blood may also||
1859|101|P|increase your risk of QT prolongation. This risk may increase if||
1859|102|P|you use certain drugs (such as diuretics/"water pills") or if you||
1859|103|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1859|104|P|Talk to your doctor about using propiverine safely.||
1859|105|P|   This drug may make you dizzy or drowsy or cause blurred||
1859|106|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
1859|107|P|Do not drive, use machinery, or do anything that needs alertness||
1859|108|P|until you can do it safely. Limit alcoholic beverages. Talk to||
1859|109|P|your doctor if you are using marijuana (cannabis).||
1859|110|P|   Before having surgery, tell your doctor or dentist about all||
1859|111|P|the products you use (including prescription drugs,||
1859|112|P|nonprescription drugs, and herbal products).||
1859|113|P|   Older adults may be more sensitive to the side effects of this||
1859|114|P|drug, especially QT prolongation (see above), drowsiness,||
1859|115|P|confusion, constipation, or trouble urinating. Drowsiness and||
1859|116|P|confusion can increase the risk of falling.||
1859|117|P|   During pregnancy, this medication should be used only when||
1859|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
1859|119|P|   It is unknown if this drug passes into breast milk. Consult||
1859|120|P|your doctor before breastfeeding.||
1859|121|B|||
1859|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1859|123|I|medications work or increase your risk for serious side effects.||
1859|124|I|This document does not contain all possible drug interactions.||
1859|125|I|Keep a list of all the products you use (including||
1859|126|I|prescription/nonprescription drugs and herbal products) and share||
1859|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
1859|128|I|the dosage of any medicines without your doctor's approval.||
1859|129|I|   Some products that may interact with this drug are: potassium||
1859|130|I|tablets/capsules, pramlintide.||
1859|131|I|   Tell your doctor or pharmacist if you are taking other||
1859|132|I|products that cause drowsiness such as opioid pain or cough||
1859|133|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1859|134|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1859|135|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1859|136|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1859|137|I|diphenhydramine).||
1859|138|I|   Check the labels on all your medicines (such as allergy or||
1859|139|I|cough-and-cold products) because they may contain ingredients||
1859|140|I|that cause drowsiness. Ask your pharmacist about using those||
1859|141|I|products safely.||
1859|142|B|||
1859|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1859|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1859|145|O|poison control center right away. US residents can call||
1859|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1859|147|O|Symptoms of overdose may include: fast/slow/irregular heartbeat,||
1859|148|O|fainting, unusual excitement, mental/mood changes.||
1859|149|B|||
1859|150|N|NOTES:  Do not share this medication with others.||
1859|151|N|   Lab and/or medical tests (such as kidney/liver function) may||
1859|152|N|be done while you are taking this medication. Keep all medical||
1859|153|N|and lab appointments.||
1859|154|B|||
1859|155|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1859|156|D|remember. If it is near the time of the next dose, skip the||
1859|157|D|missed dose. Take your next dose at the regular time. Do not||
1859|158|D|double the dose to catch up.||
1859|159|B|||
1859|160|R|STORAGE:  Store at room temperature away from light and moisture.||
1859|161|R|Do not store in the bathroom. Keep all medications away from||
1859|162|R|children and pets.||
1859|163|R|   Do not flush medications down the toilet or pour them into a||
1859|164|R|drain unless instructed to do so. Properly discard this product||
1859|165|R|when it is expired or no longer needed. Consult your pharmacist||
1859|166|R|or local waste disposal company.||
1859|167|B|||
1859|168|A|Information last revised May 2024.||
1859|169|A|Copyright(c) 2025 First Databank, Inc.||
1859|170|B|||
1860|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1860|002|Z|does NOT have all possible information about this product. This||
1860|003|Z|information does not assure that this product is safe, effective,||
1860|004|Z|or appropriate for you. This information is not individual||
1860|005|Z|medical advice and does not substitute for the advice of your||
1860|006|Z|health care professional. Always ask your health care||
1860|007|Z|professional for complete information about this product and your||
1860|008|Z|specific health needs.||
1860|009|B|||
1860|010|T|PROPIVERINE - ORAL||
1860|011|B|||
1860|012|U|USES:  This medication is used to treat an overactive bladder.||
1860|013|U|Propiverine belongs to a class of drugs known as antispasmodics.||
1860|014|U|It works by relaxing the bladder muscles to help improve your||
1860|015|U|control of urination. This effect helps reduce feelings of||
1860|016|U|needing to urinate right away, urinating very often, or being||
1860|017|U|unable to hold your urine.||
1860|018|B|||
1860|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1860|020|H|from your pharmacist before you start taking propiverine and each||
1860|021|H|time you get a refill. If you have any questions, ask your doctor||
1860|022|H|or pharmacist.||
1860|023|H|   Take this medication by mouth at least one hour before meals||
1860|024|H|as directed by your doctor, usually twice a day.||
1860|025|H|   Use this medication regularly to get the most benefit from it.||
1860|026|H|To help you remember, take it at the same times each day. The||
1860|027|H|dosage is based on your medical condition, body weight, response||
1860|028|H|to treatment, and other medications you may be taking. Be sure to||
1860|029|H|tell your doctor and pharmacist about all the products you use||
1860|030|H|(including prescription drugs, nonprescription drugs, and herbal||
1860|031|H|products). Ask your doctor or pharmacist for more details.||
1860|032|H|   Tell your doctor if your condition does not get better or if||
1860|033|H|it gets worse.||
1860|034|B|||
1860|035|S|SIDE EFFECTS:  Dry mouth, dry eyes, headache, constipation,||
1860|036|S|stomach upset/pain, dizziness, drowsiness, tiredness, or blurred||
1860|037|S|vision may occur. If any of these effects last or get worse, tell||
1860|038|S|your doctor or pharmacist promptly.||
1860|039|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
1860|040|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1860|041|S|substitute.||
1860|042|S|   To prevent constipation, eat dietary fiber, drink enough||
1860|043|S|water, and exercise. You may also need to take a laxative. Ask||
1860|044|S|your pharmacist which type of laxative is right for you.||
1860|045|S|   Remember that this medication has been prescribed because your||
1860|046|S|doctor has judged that the benefit to you is greater than the||
1860|047|S|risk of side effects. Many people using this medication do not||
1860|048|S|have serious side effects.||
1860|049|S|   Tell your doctor right away if you have any serious side||
1860|050|S|effects, including: vision changes, severe stomach/abdominal||
1860|051|S|pain, trouble urinating, signs of kidney infection (such as||
1860|052|S|burning/painful urination, lower back pain, fever).||
1860|053|S|   Get medical help right away if you have any very serious side||
1860|054|S|effects, including: fast/slow/irregular heartbeat, severe||
1860|055|S|dizziness, fainting.||
1860|056|S|   A very serious allergic reaction to this drug is rare.||
1860|057|S|However, get medical help right away if you notice any symptoms||
1860|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1860|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1860|060|S|breathing.||
1860|061|S|   This is not a complete list of possible side effects. If you||
1860|062|S|notice other effects not listed above, contact your doctor or||
1860|063|S|pharmacist.||
1860|064|S|   In the US -||
1860|065|S|   Call your doctor for medical advice about side effects. You||
1860|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1860|067|S|www.fda.gov/medwatch.||
1860|068|S|   In Canada - Call your doctor for medical advice about side||
1860|069|S|effects. You may report side effects to Health Canada at||
1860|070|S|1-866-234-2345.||
1860|071|B|||
1860|072|P|PRECAUTIONS:  Before taking propiverine, tell your doctor or||
1860|073|P|pharmacist if you are allergic to it; or if you have any other||
1860|074|P|allergies. This product may contain inactive ingredients, which||
1860|075|P|can cause allergic reactions or other problems. Talk to your||
1860|076|P|pharmacist for more details.||
1860|077|P|   Before using this medication, tell your doctor or pharmacist||
1860|078|P|your medical history, especially of: problems emptying your||
1860|079|P|bladder (urinary retention, bladder outflow obstruction),||
1860|080|P|blockage of stomach/intestines (gastric retention), glaucoma,||
1860|081|P|stomach/intestinal disease (such as ulcerative colitis, slowed||
1860|082|P|movement of stomach/intestines), severe constipation, kidney||
1860|083|P|disease, liver disease, a certain muscle disease (myasthenia||
1860|084|P|gravis).||
1860|085|P|   Propiverine may cause a condition that affects the heart||
1860|086|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1860|087|P|serious (rarely fatal) fast/irregular heartbeat and other||
1860|088|P|symptoms (such as severe dizziness, fainting) that need medical||
1860|089|P|attention right away.||
1860|090|P|   The risk of QT prolongation may be increased if you have||
1860|091|P|certain medical conditions or are taking other drugs that may||
1860|092|P|cause QT prolongation. Before using propiverine, tell your doctor||
1860|093|P|or pharmacist of all the drugs you take and if you have any of||
1860|094|P|the following conditions: certain heart problems (heart failure,||
1860|095|P|slow heartbeat, QT prolongation in the EKG), family history of||
1860|096|P|certain heart problems (QT prolongation in the EKG, sudden||
1860|097|P|cardiac death).||
1860|098|P|   Low levels of potassium or magnesium in the blood may also||
1860|099|P|increase your risk of QT prolongation. This risk may increase if||
1860|100|P|you use certain drugs (such as diuretics/"water pills") or if you||
1860|101|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1860|102|P|Talk to your doctor about using propiverine safely.||
1860|103|P|   This drug may make you dizzy or drowsy or cause blurred||
1860|104|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
1860|105|P|Do not drive, use machinery, or do anything that needs alertness||
1860|106|P|until you can do it safely. Limit alcoholic beverages. Talk to||
1860|107|P|your doctor if you are using marijuana (cannabis).||
1860|108|P|   Before having surgery, tell your doctor or dentist about all||
1860|109|P|the products you use (including prescription drugs,||
1860|110|P|nonprescription drugs, and herbal products).||
1860|111|P|   Older adults may be more sensitive to the side effects of this||
1860|112|P|drug, especially QT prolongation (see above), drowsiness,||
1860|113|P|confusion, constipation, or trouble urinating. Drowsiness and||
1860|114|P|confusion can increase the risk of falling.||
1860|115|P|   During pregnancy, this medication should be used only when||
1860|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
1860|117|P|   It is unknown if this drug passes into breast milk. Consult||
1860|118|P|your doctor before breastfeeding.||
1860|119|B|||
1860|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1860|121|I|medications work or increase your risk for serious side effects.||
1860|122|I|This document does not contain all possible drug interactions.||
1860|123|I|Keep a list of all the products you use (including||
1860|124|I|prescription/nonprescription drugs and herbal products) and share||
1860|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1860|126|I|the dosage of any medicines without your doctor's approval.||
1860|127|I|   Some products that may interact with this drug are: potassium||
1860|128|I|tablets/capsules, pramlintide.||
1860|129|I|   Tell your doctor or pharmacist if you are taking other||
1860|130|I|products that cause drowsiness such as opioid pain or cough||
1860|131|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1860|132|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1860|133|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1860|134|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1860|135|I|diphenhydramine).||
1860|136|I|   Check the labels on all your medicines (such as allergy or||
1860|137|I|cough-and-cold products) because they may contain ingredients||
1860|138|I|that cause drowsiness. Ask your pharmacist about using those||
1860|139|I|products safely.||
1860|140|B|||
1860|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1860|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1860|143|O|poison control center right away. US residents can call||
1860|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1860|145|O|Symptoms of overdose may include: fast/slow/irregular heartbeat,||
1860|146|O|fainting, unusual excitement, mental/mood changes.||
1860|147|B|||
1860|148|N|NOTES:  Do not share this medication with others.||
1860|149|N|   Lab and/or medical tests (such as kidney/liver function) may||
1860|150|N|be done while you are taking this medication. Keep all medical||
1860|151|N|and lab appointments.||
1860|152|B|||
1860|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1860|154|D|remember. If it is near the time of the next dose, skip the||
1860|155|D|missed dose. Take your next dose at the regular time. Do not||
1860|156|D|double the dose to catch up.||
1860|157|B|||
1860|158|R|STORAGE:  Store at room temperature away from light and moisture.||
1860|159|R|Do not store in the bathroom. Keep all medications away from||
1860|160|R|children and pets.||
1860|161|R|   Do not flush medications down the toilet or pour them into a||
1860|162|R|drain unless instructed to do so. Properly discard this product||
1860|163|R|when it is expired or no longer needed. Consult your pharmacist||
1860|164|R|or local waste disposal company.||
1860|165|B|||
1860|166|A|Information last revised May 2024.||
1860|167|A|Copyright(c) 2025 First Databank, Inc.||
1860|168|B|||
1862|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1862|002|Z|does NOT have all possible information about this product. This||
1862|003|Z|information does not assure that this product is safe, effective,||
1862|004|Z|or appropriate for you. This information is not individual||
1862|005|Z|medical advice and does not substitute for the advice of your||
1862|006|Z|health care professional. Always ask your health care||
1862|007|Z|professional for complete information about this product and your||
1862|008|Z|specific health needs.||
1862|009|B|||
1862|010|T|TRIPTORELIN 6 MONTH PEDIATRIC (22.5 MG) - INJECTION||
1862|011|F|(TRIP-toe-REL-in)||
1862|012|B|||
1862|013|C|COMMON BRAND NAME(S): Triptodur||
1862|014|B|||
1862|015|U|USES:  Triptorelin is used to stop early puberty (precocious||
1862|016|U|puberty) in children. It helps to delay sexual development (such||
1862|017|U|as growth of the breasts/testicles) and the start of menstrual||
1862|018|U|periods. It also helps slow down early bone growth to increase||
1862|019|U|the likelihood of reaching normal adult height. Triptorelin works||
1862|020|U|by decreasing the amount of sex hormones that a child's body||
1862|021|U|makes (estrogen in girls, testosterone in boys).||
1862|022|B|||
1862|023|H|HOW TO USE:  Read the Medication Guide provided by your||
1862|024|H|pharmacist before you start using triptorelin and each time you||
1862|025|H|get a refill. If you have any questions, ask your doctor or||
1862|026|H|pharmacist.||
1862|027|H|   This medication is given by injection into the muscle of your||
1862|028|H|buttocks or thighs by a health care professional as directed by||
1862|029|H|your doctor, usually once every 6 months.||
1862|030|H|   Use this medication regularly to get the most benefit from it.||
1862|031|H|To help you remember, mark your calendar with a reminder.||
1862|032|H|   During the first few weeks of treatment, hormone levels will||
1862|033|H|actually go up before they go down. This is a normal response to||
1862|034|H|this medication. You may notice worsening symptoms of early||
1862|035|H|puberty (such as menstrual periods) at the start of treatment.||
1862|036|H|However, you should see an improvement in symptoms usually within||
1862|037|H|1 to 2 months. Tell your doctor promptly if new or worsened||
1862|038|H|symptoms develop after starting treatment.||
1862|039|B|||
1862|040|S|SIDE EFFECTS:  Pain/redness/itching/swelling at the injection||
1862|041|S|site, hot flashes (flushing), headache, or vaginal bleeding may||
1862|042|S|occur. If any of these effects last or get worse, tell your||
1862|043|S|doctor or pharmacist promptly.||
1862|044|S|   Remember that this medication has been prescribed because your||
1862|045|S|doctor has judged that the benefit to you is greater than the||
1862|046|S|risk of side effects. Many people using this medication do not||
1862|047|S|have serious side effects.||
1862|048|S|   Tell your doctor right away if you have any serious side||
1862|049|S|effects, including: mental/mood changes (such as depression,||
1862|050|S|thoughts of suicide, mood swings, aggression).||
1862|051|S|   Get medical help right away if you have any very serious side||
1862|052|S|effects, including: seizures.||
1862|053|S|   Children using triptorelin may be at risk for increased||
1862|054|S|pressure around the brain (intracranial hypertension). Get||
1862|055|S|medical help right away if your child has any of these very||
1862|056|S|serious side effects: nausea/vomiting that doesn't stop, headache||
1862|057|S|that is severe or doesn't go away, eye pain, vision changes (such||
1862|058|S|as blurred/double vision, decreased vision), ringing in the ears.||
1862|059|S|   A very serious allergic reaction to this drug is rare.||
1862|060|S|However, get medical help right away if you notice any symptoms||
1862|061|S|of a serious allergic reaction, including: fever, swollen lymph||
1862|062|S|nodes, rash, itching/swelling (especially of the||
1862|063|S|face/tongue/throat), severe dizziness, trouble breathing.||
1862|064|S|   This is not a complete list of possible side effects. If you||
1862|065|S|notice other effects not listed above, contact your doctor or||
1862|066|S|pharmacist.||
1862|067|S|   In the US -||
1862|068|S|   Call your doctor for medical advice about side effects. You||
1862|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1862|070|S|www.fda.gov/medwatch.||
1862|071|S|   In Canada - Call your doctor for medical advice about side||
1862|072|S|effects. You may report side effects to Health Canada at||
1862|073|S|1-866-234-2345.||
1862|074|B|||
1862|075|P|PRECAUTIONS:  Before using triptorelin, tell your doctor or||
1862|076|P|pharmacist if you are allergic to it; or to other GnRH-type drugs||
1862|077|P|(such as leuprolide); or if you have any other allergies. This||
1862|078|P|product may contain inactive ingredients, which can cause||
1862|079|P|allergic reactions or other problems. Talk to your pharmacist for||
1862|080|P|more details.||
1862|081|P|   Before using this medication, tell your doctor or pharmacist||
1862|082|P|your medical history, especially of: mental/mood problems (such||
1862|083|P|as depression), seizures.||
1862|084|P|   Before having surgery, tell your doctor or dentist about all||
1862|085|P|the products you use (including prescription drugs,||
1862|086|P|nonprescription drugs, and herbal products).||
1862|087|P|   This medication must not be used during pregnancy. It may harm||
1862|088|P|an unborn baby. If you become pregnant or think you may be||
1862|089|P|pregnant, tell your doctor right away.||
1862|090|P|   It is unknown if triptorelin passes into breast milk. Because||
1862|091|P|of the possible risk to the infant, breastfeeding is not||
1862|092|P|recommended while using this medication. Consult your doctor||
1862|093|P|before breastfeeding.||
1862|094|B|||
1862|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1862|096|I|medications work or increase your risk for serious side effects.||
1862|097|I|This document does not contain all possible drug interactions.||
1862|098|I|Keep a list of all the products you use (including||
1862|099|I|prescription/nonprescription drugs and herbal products) and share||
1862|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
1862|101|I|the dosage of any medicines without your doctor's approval.||
1862|102|I|   This medication may interfere with certain lab tests, possibly||
1862|103|I|causing false test results. Make sure lab personnel and all your||
1862|104|I|doctors know you use this drug.||
1862|105|B|||
1862|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1862|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1862|108|O|poison control center right away. US residents can call||
1862|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1862|110|B|||
1862|111|N|NOTES:  Lab and/or medical tests (such as hormone levels, height||
1862|112|N|measurements, bone tests) should be done while using this||
1862|113|N|medication. Keep all medical and lab appointments. Consult your||
1862|114|N|doctor for more details.||
1862|115|B|||
1862|116|D|MISSED DOSE:  It is important to get each dose of this medication||
1862|117|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1862|118|D|right away for a new dosing schedule.||
1862|119|B|||
1862|120|R|STORAGE:  Not applicable. This medication is given in a doctor's||
1862|121|R|office and will not be stored at home.||
1862|122|B|||
1862|123|A|Information last revised September 2025.||
1862|124|A|Copyright(c) 2025 First Databank, Inc.||
1862|125|B|||
1863|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1863|002|Z|does NOT have all possible information about this product. This||
1863|003|Z|information does not assure that this product is safe, effective,||
1863|004|Z|or appropriate for you. This information is not individual||
1863|005|Z|medical advice and does not substitute for the advice of your||
1863|006|Z|health care professional. Always ask your health care||
1863|007|Z|professional for complete information about this product and your||
1863|008|Z|specific health needs.||
1863|009|B|||
1863|010|T|ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL||
1863|011|F|(EL-vi-TEG-ra-vir/koe-BIK-i-stat/EM-trye-SYE-ta-been/||
1863|012|F|ten-OF-oh-vir AL-a-FEN-a-mide)||
1863|013|B|||
1863|014|C|COMMON BRAND NAME(S): Genvoya||
1863|015|B|||
1863|016|W|WARNING:  If you have hepatitis B infection, your hepatitis||
1863|017|W|symptoms may get worse or become very serious if you stop taking||
1863|018|W|this medication. Talk with your doctor before stopping this||
1863|019|W|medication. Your doctor will monitor liver tests for several||
1863|020|W|months after you stop||
1863|021|W|elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. Tell||
1863|022|W|your doctor right away if you have symptoms of worsening liver||
1863|023|W|problems.||
1863|024|B|||
1863|025|U|USES:  This product is used to help control HIV infection. It||
1863|026|U|helps to decrease the amount of HIV in your body so your immune||
1863|027|U|system can work better. This lowers your chance of getting HIV||
1863|028|U|complications (such as new infections, cancer) and improves your||
1863|029|U|quality of life. This product contains 4 different medications:||
1863|030|U|elvitegravir, cobicistat, emtricitabine, and tenofovir||
1863|031|U|alafenamide. Elvitegravir is known as an integrase inhibitor.||
1863|032|U|Cobicistat helps elvitegravir work better. Emtricitabine is||
1863|033|U|called a nucleoside reverse transcriptase inhibitor, while||
1863|034|U|tenofovir alafenamide is called a nucleotide reverse||
1863|035|U|transcriptase inhibitor; both kinds of drugs are often called||
1863|036|U|NRTIs.||
1863|037|U|   Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide is||
1863|038|U|not a cure for HIV infection. To decrease your risk of spreading||
1863|039|U|HIV disease to others, continue to take all HIV medications||
1863|040|U|exactly as prescribed by your doctor. Use an effective barrier||
1863|041|U|method (latex or polyurethane condoms/dental dams) during sexual||
1863|042|U|activity as directed by your doctor. Do not share personal items||
1863|043|U|(such as needles/syringes, toothbrushes, and razors) that may||
1863|044|U|have contacted blood or other body fluids. Consult your doctor or||
1863|045|U|pharmacist for more details.||
1863|046|B|||
1863|047|V|OTHER USES:  This section contains uses of this drug that are not||
1863|048|V|listed in the approved professional labeling for the drug but||
1863|049|V|that may be prescribed by your health care professional. Use this||
1863|050|V|drug for a condition that is listed in this section only if it||
1863|051|V|has been so prescribed by your health care professional.||
1863|052|V|   This product may also be used to reduce the risk of getting||
1863|053|V|HIV infection after contact with the virus. Consult your doctor||
1863|054|V|for more details.||
1863|055|B|||
1863|056|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1863|057|H|from your pharmacist before you start taking this medication and||
1863|058|H|each time you get a refill. If you have any questions, ask your||
1863|059|H|doctor or pharmacist.||
1863|060|H|   Take this medication by mouth with food as directed by your||
1863|061|H|doctor, usually once daily.||
1863|062|H|   It is very important to keep taking this medication exactly as||
1863|063|H|prescribed by your doctor. Do not skip any doses.||
1863|064|H|   Take this medication at least 2 hours before or 2 hours after||
1863|065|H|taking other products that may make it work less well. Some||
1863|066|H|examples include: sucralfate, antacids, and vitamins/minerals||
1863|067|H|that contain magnesium, aluminum, calcium, iron, or zinc.||
1863|068|H|   For the best effect, take this medication at evenly spaced||
1863|069|H|times. To help you remember, take this medication at the same||
1863|070|H|time every day.||
1863|071|H|   Do not take more or less of this drug than prescribed or stop||
1863|072|H|taking it even for a short time unless directed to do so by your||
1863|073|H|doctor. Doing so may cause the amount of virus to increase, make||
1863|074|H|the infection more difficult to treat (resistant), or worsen side||
1863|075|H|effects.||
1863|076|B|||
1863|077|S|SIDE EFFECTS:  Diarrhea, nausea, headache, or tiredness may||
1863|078|S|occur. If any of these effects last or get worse, tell your||
1863|079|S|doctor or pharmacist promptly.||
1863|080|S|   Remember that this medication has been prescribed because your||
1863|081|S|doctor has judged that the benefit to you is greater than the||
1863|082|S|risk of side effects. Many people using this medication do not||
1863|083|S|have serious side effects.||
1863|084|S|   As your immune system gets stronger, it can begin to fight off||
1863|085|S|infections you already had, possibly causing disease symptoms to||
1863|086|S|come back. You could also have symptoms if your immune system||
1863|087|S|becomes overactive. This reaction may happen at any time (soon||
1863|088|S|after starting HIV treatment or many months later). Tell your||
1863|089|S|doctor right away if you have any serious symptoms, including:||
1863|090|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1863|091|S|that doesn't go away, headaches that are severe or don't go away,||
1863|092|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1863|093|S|changes, signs of infection (such as sore throat that doesn't go||
1863|094|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1863|095|S|sores), signs of an overactive thyroid (such as irritability,||
1863|096|S|nervousness, heat intolerance, fast/pounding/irregular||
1863|097|S|heartbeat).||
1863|098|S|   Tell your doctor right away if you have any serious side||
1863|099|S|effects, including: mental/mood changes (such as depression,||
1863|100|S|anxiety), signs of kidney problems (such as change in the amount||
1863|101|S|of urine, pink/bloody urine).||
1863|102|S|   Rarely, this medication can cause severe (sometimes fatal)||
1863|103|S|liver and blood problems (lactic acidosis). Tell your doctor||
1863|104|S|right away if you develop symptoms of liver problems (such as||
1863|105|S|nausea/vomiting that doesn't stop, loss of appetite,||
1863|106|S|stomach/abdominal pain, yellowing eyes/skin, dark urine) or||
1863|107|S|lactic acidosis (such as deep/rapid breathing, drowsiness,||
1863|108|S|nausea/vomiting, unusual weakness).||
1863|109|S|   A very serious allergic reaction to this drug is rare.||
1863|110|S|However, get medical help right away if you notice any symptoms||
1863|111|S|of a serious allergic reaction, including: rash, itching/swelling||
1863|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1863|113|S|breathing.||
1863|114|S|   This is not a complete list of possible side effects. If you||
1863|115|S|notice other effects not listed above, contact your doctor or||
1863|116|S|pharmacist.||
1863|117|S|   In the US -||
1863|118|S|   Call your doctor for medical advice about side effects. You||
1863|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1863|120|S|www.fda.gov/medwatch.||
1863|121|S|   In Canada - Call your doctor for medical advice about side||
1863|122|S|effects. You may report side effects to Health Canada at||
1863|123|S|1-866-234-2345.||
1863|124|B|||
1863|125|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1863|126|P|pharmacist if you are allergic to elvitegravir, cobicistat,||
1863|127|P|emtricitabine, or tenofovir; or if you have any other allergies.||
1863|128|P|This product may contain inactive ingredients, which can cause||
1863|129|P|allergic reactions or other problems. Talk to your pharmacist for||
1863|130|P|more details.||
1863|131|P|   Before using this medication, tell your doctor or pharmacist||
1863|132|P|your medical history, especially of: liver problems (hepatitis B,||
1863|133|P|hepatitis C, cirrhosis), alcohol use, bone problems (such as bone||
1863|134|P|disease, bone loss/osteoporosis, weak/broken bones), kidney||
1863|135|P|disease, pancreatitis.||
1863|136|P|   Before having surgery, tell your doctor or dentist about all||
1863|137|P|the products you use (including prescription drugs,||
1863|138|P|nonprescription drugs, and herbal products).||
1863|139|P|   This medication is not recommended for use during pregnancy.||
1863|140|P|It may not work well in a pregnant woman. If you become pregnant||
1863|141|P|or think you may be pregnant, tell your doctor right away. Your||
1863|142|P|doctor may change your HIV medications.||
1863|143|P|   Emtricitabine and tenofovir alafenamide pass into breast milk.||
1863|144|P|It is unknown if elvitegravir or cobicistat pass into breast||
1863|145|P|milk. Because breast milk may transmit HIV, consult your doctor||
1863|146|P|before breastfeeding.||
1863|147|B|||
1863|148|I|DRUG INTERACTIONS:  See also How To Use section.||
1863|149|I|   Drug interactions may change how your medications work or||
1863|150|I|increase your risk for serious side effects. This document does||
1863|151|I|not contain all possible drug interactions. Keep a list of all||
1863|152|I|the products you use (including prescription/nonprescription||
1863|153|I|drugs and herbal products) and share it with your doctor and||
1863|154|I|pharmacist. Do not start, stop, or change the dosage of any||
1863|155|I|medicines without your doctor's approval.||
1863|156|I|   Some products that may interact with this drug are: adefovir,||
1863|157|I|orlistat, other drugs that may affect the kidneys (including||
1863|158|I|aminoglycosides such as amikacin/gentamicin).||
1863|159|I|   Do not take this medication with other HIV medications (such||
1863|160|I|as ritonavir). Do not take this medication with other products||
1863|161|I|that contain cobicistat, elvitegravir, emtricitabine, lamivudine,||
1863|162|I|or tenofovir.||
1863|163|I|   This medication can slow down the removal of other medications||
1863|164|I|from your body, which may affect how they work. Examples of||
1863|165|I|affected drugs include dronedarone, eletriptan, eplerenone, ergot||
1863|166|I|alkaloids (such as ergotamine, dihydroergotamine), salmeterol,||
1863|167|I|tolvaptan, rivaroxaban, certain alpha blockers (such as||
1863|168|I|alfuzosin, tamsulosin), certain benzodiazepines (such as||
1863|169|I|midazolam, triazolam), certain statins (such as lovastatin,||
1863|170|I|simvastatin), certain drugs to treat erectile dysfunction-ED or||
1863|171|I|pulmonary hypertension (such as avanafil, sildenafil), among||
1863|172|I|others.||
1863|173|I|   Other medications can affect the removal of this medication||
1863|174|I|from your body, which may affect how this medication works.||
1863|175|I|Examples include mitotane, rifampin, St. John's wort, certain||
1863|176|I|drugs used to treat seizures (such as carbamazepine,||
1863|177|I|oxcarbazepine, phenobarbital, phenytoin, primidone), among||
1863|178|I|others.||
1863|179|I|   This medication may decrease the effectiveness of hormonal||
1863|180|I|birth control such as pills, patch, or ring. This could cause||
1863|181|I|pregnancy. This medication may also increase the risk of some||
1863|182|I|hormonal birth control side effects. Talk to your doctor about||
1863|183|I|other reliable forms of birth control, and use an effective||
1863|184|I|barrier method (latex or polyurethane condoms/dental dams) during||
1863|185|I|sexual activity to decrease the risk of spreading HIV to others.||
1863|186|I|Tell your doctor if you have any new spotting or breakthrough||
1863|187|I|bleeding, because these may be signs that your hormonal birth||
1863|188|I|control is not working well.||
1863|189|B|||
1863|190|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1863|191|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1863|192|O|poison control center right away. US residents can call||
1863|193|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1863|194|B|||
1863|195|N|NOTES:  Do not share this medication with others.||
1863|196|N|   Lab and/or medical tests (such as kidney/liver function, test||
1863|197|N|for hepatitis B virus, viral load, T-cell counts, blood mineral||
1863|198|N|levels, bone density tests, urine glucose/protein) should be done||
1863|199|N|before you start taking this medication and while you are taking||
1863|200|N|it. Keep all medical and lab appointments. Consult your doctor||
1863|201|N|for more details.||
1863|202|B|||
1863|203|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1863|204|D|remember. If it is near the time of the next dose, skip the||
1863|205|D|missed dose. Take your next dose at the regular time. Do not||
1863|206|D|double the dose to catch up.||
1863|207|B|||
1863|208|R|STORAGE:  Store in the original container at room temperature||
1863|209|R|away from light and moisture. Do not store in the bathroom. Keep||
1863|210|R|all medications away from children and pets.||
1863|211|R|   Do not flush medications down the toilet or pour them into a||
1863|212|R|drain unless instructed to do so. Properly discard this product||
1863|213|R|when it is expired or no longer needed. Consult your pharmacist||
1863|214|R|or local waste disposal company.||
1863|215|B|||
1863|216|A|Information last revised April 2025.||
1863|217|A|Copyright(c) 2025 First Databank, Inc.||
1863|218|B|||
1864|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1864|002|Z|does NOT have all possible information about this product. This||
1864|003|Z|information does not assure that this product is safe, effective,||
1864|004|Z|or appropriate for you. This information is not individual||
1864|005|Z|medical advice and does not substitute for the advice of your||
1864|006|Z|health care professional. Always ask your health care||
1864|007|Z|professional for complete information about this product and your||
1864|008|Z|specific health needs.||
1864|009|B|||
1864|010|T|TISAGENLECLEUCEL - INJECTION||
1864|011|F|(TIS-a-JEN-lek-LOO-sel)||
1864|012|B|||
1864|013|C|COMMON BRAND NAME(S): Kymriah||
1864|014|B|||
1864|015|W|WARNING:  This medication may cause a serious (even fatal)||
1864|016|W|reaction called cytokine release syndrome-CRS. Careful monitoring||
1864|017|W|and prompt treatment may decrease your risk. Before treatment||
1864|018|W|with this medication, tell your doctor your medical history,||
1864|019|W|especially of any current/recent infection. Tell your doctor||
1864|020|W|right away if you have any symptoms of CRS such as high fever,||
1864|021|W|difficulty breathing, chills/shaking chills, severe||
1864|022|W|nausea/vomiting/diarrhea, severe muscle/joint pain, very low||
1864|023|W|blood pressure, dizziness/lightheadedness.||
1864|024|W|   Serious nerve problems can occur after treatment with||
1864|025|W|tisagenlecleucel. Tell your doctor right away if you have trouble||
1864|026|W|speaking and understanding, loss of balance, or mental/mood||
1864|027|W|changes such as anxiety, confusion, agitation.||
1864|028|B|||
1864|029|U|USES:  Tisagenlecleucel is used to treat certain types of cancer||
1864|030|U|(acute lymphoblastic leukemia-ALL, B-cell lymphoma, follicular||
1864|031|U|lymphoma). This type of treatment is known as gene therapy.||
1864|032|U|Tisagenlecleucel is made from your own white blood cells and is||
1864|033|U|given only to you. The white blood cells have been changed to||
1864|034|U|have a specific protein (chimeric antigen receptor-CAR) that||
1864|035|U|helps your body slow or stop the growth of certain cancer cells.||
1864|036|B|||
1864|037|H|HOW TO USE:  Read the Medication Guide provided by your||
1864|038|H|healthcare professional before you start using this product. If||
1864|039|H|you have any questions, ask your healthcare professional(s).||
1864|040|H|   Before you get treatment with this product, your doctor may||
1864|041|H|give you chemotherapy for a few days to prepare your body.||
1864|042|H|   This product is given by slow injection into a vein as||
1864|043|H|directed by your doctor, usually over less than one hour. To||
1864|044|H|decrease the risk of side effects, your doctor may also give you||
1864|045|H|other medications (such as acetaminophen, diphenhydramine) before||
1864|046|H|injecting tisagenlecleucel. The dosage is based on your medical||
1864|047|H|condition and weight. You should plan to stay for at least 2||
1864|048|H|weeks near the place of your treatment (for example, within 2||
1864|049|H|hours' drive). Your doctor will check to see if your treatment is||
1864|050|H|working and help you manage any side effects.||
1864|051|B|||
1864|052|S|SIDE EFFECTS:  See also Warning section.||
1864|053|S|   Headache, tiredness, or loss of appetite may occur. If any of||
1864|054|S|these effects last or get worse, tell your doctor or pharmacist||
1864|055|S|promptly.||
1864|056|S|   People using this medication may have serious side effects.||
1864|057|S|However, you have been prescribed this drug because your doctor||
1864|058|S|has judged that the benefit to you is greater than the risk of||
1864|059|S|side effects. Careful monitoring by your doctor may decrease your||
1864|060|S|risk.||
1864|061|S|   Although tisagenlecleucel is used to treat cancer, it may||
1864|062|S|rarely increase your risk of developing other cancers. Also, this||
1864|063|S|product may cause a severe decrease in your blood cells, which||
1864|064|S|lowers your ability to fight infections and increases the risk of||
1864|065|S|anemia/bleeding problems. You may be more likely to get a serious||
1864|066|S|(rarely fatal) infection and any infection you have may get||
1864|067|S|worse. Tell your doctor right away if you develop unusual growths||
1864|068|S|or lumps, swollen lymph nodes, signs of infection (such as sore||
1864|069|S|throat that doesn't go away, fever, chills), easy or unusual||
1864|070|S|bruising/bleeding, or unusual tiredness.||
1864|071|S|   A very serious allergic reaction to this drug is rare.||
1864|072|S|However, get medical help right away if you notice any symptoms||
1864|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1864|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1864|075|S|breathing.||
1864|076|S|   This is not a complete list of possible side effects. If you||
1864|077|S|notice other effects not listed above, contact your doctor or||
1864|078|S|pharmacist.||
1864|079|S|   In the US -||
1864|080|S|   Call your doctor for medical advice about side effects. You||
1864|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1864|082|S|www.fda.gov/medwatch.||
1864|083|S|   In Canada - Call your doctor for medical advice about side||
1864|084|S|effects. You may report side effects to Health Canada at||
1864|085|S|1-866-234-2345.||
1864|086|B|||
1864|087|P|PRECAUTIONS:  Before receiving tisagenlecleucel, tell your doctor||
1864|088|P|or pharmacist if you have any allergies. This product may contain||
1864|089|P|inactive ingredients, which can cause allergic reactions or other||
1864|090|P|problems. Talk to your pharmacist for more details.||
1864|091|P|   Before using this medication, tell your doctor or pharmacist||
1864|092|P|your medical history, especially of: past/current/recent||
1864|093|P|infection (including hepatitis, HIV), bleeding/blood problems.||
1864|094|P|   This product can make you more likely to get infections or may||
1864|095|P|make current infections worse. Stay away from anyone who has an||
1864|096|P|infection that may easily spread (such as chickenpox, COVID-19,||
1864|097|P|measles, flu). Talk to your doctor if you have been exposed to an||
1864|098|P|infection or for more details.||
1864|099|P|   Tell your health care professional that you are using||
1864|100|P|tisagenlecleucel before having any immunizations/vaccinations.||
1864|101|P|Avoid contact with people who have recently received live||
1864|102|P|vaccines (such as flu vaccine inhaled through the nose).||
1864|103|P|   To lower the chance of getting cut, bruised, or injured, use||
1864|104|P|caution with sharp objects like razors and nail cutters, and||
1864|105|P|avoid activities such as contact sports.||
1864|106|P|   This drug may make you dizzy, affect your coordination, or||
1864|107|P|make it harder for you to think clearly. Alcohol or marijuana||
1864|108|P|(cannabis) can worsen these effects. Do not drive, use machinery,||
1864|109|P|or do anything that needs alertness until you can do it safely||
1864|110|P|(at least 2 weeks after receiving treatment is recommended by the||
1864|111|P|manufacturer). Limit alcoholic beverages. Talk to your doctor if||
1864|112|P|you are using marijuana (cannabis).||
1864|113|P|   Before having surgery, tell your doctor or dentist about all||
1864|114|P|the products you use (including prescription drugs,||
1864|115|P|nonprescription drugs, and herbal products).||
1864|116|P|   Tell your doctor if you are pregnant or plan to become||
1864|117|P|pregnant. You should not become pregnant while using||
1864|118|P|tisagenlecleucel. Tisagenlecleucel may harm an unborn baby. Your||
1864|119|P|doctor should order a pregnancy test before you start this||
1864|120|P|medication. If you become pregnant, talk to your doctor right||
1864|121|P|away about the risks and benefits of this medication.||
1864|122|P|   It is unknown if this product passes into breast milk. Consult||
1864|123|P|your doctor before breastfeeding.||
1864|124|B|||
1864|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1864|126|I|medications work or increase your risk for serious side effects.||
1864|127|I|This document does not contain all possible drug interactions.||
1864|128|I|Keep a list of all the products you use (including||
1864|129|I|prescription/nonprescription drugs and herbal products) and share||
1864|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
1864|131|I|the dosage of any medicines without your doctor's approval.||
1864|132|I|   This product may interfere with certain lab tests (such as||
1864|133|I|some HIV tests), possibly causing false test results. Make sure||
1864|134|I|lab personnel and all your doctors know you use this drug.||
1864|135|B|||
1864|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1864|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1864|138|O|poison control center right away. US residents can call||
1864|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1864|140|B|||
1864|141|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
1864|142|N|should be done before and after you receive this product. Keep||
1864|143|N|all medical and lab appointments.||
1864|144|B|||
1864|145|D|MISSED DOSE:  If your dose is interrupted or stopped, ask your||
1864|146|D|doctor or pharmacist right away for a new dosing schedule.||
1864|147|B|||
1864|148|R|STORAGE:  Not applicable. This product is given in a hospital or||
1864|149|R|clinic and will not be stored at home.||
1864|150|B|||
1864|151|M|MEDICAL ALERT:  Your condition can cause complications in a||
1864|152|M|medical emergency. For information about enrolling in MedicAlert,||
1864|153|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1864|154|B|||
1864|155|A|Information last revised June 2025.||
1864|156|A|Copyright(c) 2025 First Databank, Inc.||
1864|157|B|||
1865|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1865|002|Z|does NOT have all possible information about this product. This||
1865|003|Z|information does not assure that this product is safe, effective,||
1865|004|Z|or appropriate for you. This information is not individual||
1865|005|Z|medical advice and does not substitute for the advice of your||
1865|006|Z|health care professional. Always ask your health care||
1865|007|Z|professional for complete information about this product and your||
1865|008|Z|specific health needs.||
1865|009|B|||
1865|010|T|EMTRICITABINE/RILPIVIRINE/TENOFOVIR ALAFENAMIDE - ORAL||
1865|011|F|(EM-trye-SYE-ta-been/RIL-pi-VIR-een/ten-OF-oh-vir AL-a-FEN-a-mide)||
1865|012|B|||
1865|013|C|COMMON BRAND NAME(S): Odefsey||
1865|014|B|||
1865|015|W|WARNING:  If you have hepatitis B infection, your hepatitis||
1865|016|W|symptoms may get worse or become very serious if you stop taking||
1865|017|W|this medication. Talk with your doctor before stopping this||
1865|018|W|medication. Your doctor will monitor liver tests for several||
1865|019|W|months after you stop emtricitabine/rilpivirine/tenofovir||
1865|020|W|alafenamide. Tell your doctor right away if you have symptoms of||
1865|021|W|worsening liver problems.||
1865|022|B|||
1865|023|U|USES:  This product contains 3 different medications:||
1865|024|U|emtricitabine, rilpivirine, and tenofovir alafenamide. It is used||
1865|025|U|to help control HIV infection. It helps to decrease the amount of||
1865|026|U|HIV in your body so your immune system can work better. This||
1865|027|U|lowers your chance of getting HIV complications (such as new||
1865|028|U|infections, cancer) and improves your quality of life.||
1865|029|U|Emtricitabine and tenofovir alafenamide belong to a class of||
1865|030|U|drugs known as nucleoside reverse transcriptase inhibitors||
1865|031|U|(NRTIs). Rilpivirine belongs to a class of drugs known as||
1865|032|U|non-nucleoside reverse transcriptase inhibitors (NNRTIs).||
1865|033|U|   Emtricitabine/rilpivirine/tenofovir alafenamide is not a cure||
1865|034|U|for HIV infection. To decrease your risk of spreading HIV disease||
1865|035|U|to others, continue to take all HIV medications exactly as||
1865|036|U|prescribed by your doctor. Use an effective barrier method (latex||
1865|037|U|or polyurethane condoms/dental dams) during sexual activity as||
1865|038|U|directed by your doctor. Do not share personal items (such as||
1865|039|U|needles/syringes, toothbrushes, and razors) that may have||
1865|040|U|contacted blood or other body fluids. Consult your doctor or||
1865|041|U|pharmacist for more details.||
1865|042|B|||
1865|043|V|OTHER USES:  This section contains uses of this drug that are not||
1865|044|V|listed in the approved professional labeling for the drug but||
1865|045|V|that may be prescribed by your health care professional. Use this||
1865|046|V|drug for a condition that is listed in this section only if it||
1865|047|V|has been so prescribed by your health care professional.||
1865|048|V|   This product may also be used to reduce the risk of getting||
1865|049|V|HIV infection after contact with the virus. Consult your doctor||
1865|050|V|for more details.||
1865|051|B|||
1865|052|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1865|053|H|from your pharmacist before you start taking this medication and||
1865|054|H|each time you get a refill. If you have any questions, ask your||
1865|055|H|doctor or pharmacist.||
1865|056|H|   Take this medication by mouth with a meal as directed by your||
1865|057|H|doctor, usually once daily.||
1865|058|H|   Medications that reduce stomach acid (such as antacids, proton||
1865|059|H|pump inhibitors/PPIs, H2 blockers) may make rilpivirine work less||
1865|060|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
1865|061|H|using this medication. If you take antacids, take the antacids at||
1865|062|H|least 2 hours before or at least 4 hours after this medication.||
1865|063|H|If you take H2 blockers (such as famotidine, nizatidine), take||
1865|064|H|them at least 12 hours before or at least 4 hours after this||
1865|065|H|medication.||
1865|066|H|   It is very important to keep taking this medication exactly as||
1865|067|H|prescribed by your doctor. Do not take less of this drug than||
1865|068|H|prescribed or stop taking it even for a short time unless||
1865|069|H|directed to do so by your doctor. Doing so may cause the amount||
1865|070|H|of virus to increase and/or make the infection more difficult to||
1865|071|H|treat (resistant).||
1865|072|H|   Do not increase your dose or take this medication more often||
1865|073|H|than prescribed. Your condition will not improve any faster, and||
1865|074|H|your risk of side effects may increase.||
1865|075|H|   For the best effect, take this medication at evenly spaced||
1865|076|H|times. To help you remember, take this medication at the same||
1865|077|H|time every day.||
1865|078|B|||
1865|079|S|SIDE EFFECTS:  Headache or trouble sleeping may occur. If either||
1865|080|S|of these effects lasts or gets worse, tell your doctor or||
1865|081|S|pharmacist promptly.||
1865|082|S|   Remember that this medication has been prescribed because your||
1865|083|S|doctor has judged that the benefit to you is greater than the||
1865|084|S|risk of side effects. Many people using this medication do not||
1865|085|S|have serious side effects.||
1865|086|S|   As your immune system gets stronger, it can begin to fight off||
1865|087|S|infections you already had, possibly causing disease symptoms to||
1865|088|S|come back. You could also have symptoms if your immune system||
1865|089|S|becomes overactive. This reaction may happen at any time (soon||
1865|090|S|after starting HIV treatment or many months later). Tell your||
1865|091|S|doctor right away if you have any serious symptoms, including:||
1865|092|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1865|093|S|that doesn't go away, headaches that are severe or don't go away,||
1865|094|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1865|095|S|changes, signs of infection (such as sore throat that doesn't go||
1865|096|S|away, fever, chills, non-healing skin sores), signs of an||
1865|097|S|overactive thyroid (such as irritability, nervousness, heat||
1865|098|S|intolerance, fast/pounding/irregular heartbeat), signs of liver||
1865|099|S|disease (such as nausea/vomiting that doesn't stop, loss of||
1865|100|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1865|101|S|urine).||
1865|102|S|   Tell your doctor right away if you have any serious side||
1865|103|S|effects, including: signs of kidney problems (such as change in||
1865|104|S|the amount of urine, pink/bloody urine), mental/mood changes||
1865|105|S|(such as depression, thoughts of suicide).||
1865|106|S|   Rarely, this medication can cause a severe (sometimes fatal)||
1865|107|S|blood problem (lactic acidosis). Tell your doctor right away if||
1865|108|S|you develop symptoms of lactic acidosis (such as deep/rapid||
1865|109|S|breathing, drowsiness, nausea/vomiting, unusual weakness).||
1865|110|S|   This medication can commonly cause a rash that is usually not||
1865|111|S|serious. However, you may not be able to tell it apart from a||
1865|112|S|rare rash that could be a sign of a severe reaction. Get medical||
1865|113|S|help right away if you develop any rash.||
1865|114|S|   A very serious allergic reaction to this drug is rare.||
1865|115|S|However, get medical help right away if you notice any symptoms||
1865|116|S|of a serious allergic reaction, including: swollen lymph nodes,||
1865|117|S|rash, itching/swelling (especially of the face/tongue/throat),||
1865|118|S|severe dizziness, trouble breathing.||
1865|119|S|   This is not a complete list of possible side effects. If you||
1865|120|S|notice other effects not listed above, contact your doctor or||
1865|121|S|pharmacist.||
1865|122|S|   In the US -||
1865|123|S|   Call your doctor for medical advice about side effects. You||
1865|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1865|125|S|www.fda.gov/medwatch.||
1865|126|S|   In Canada - Call your doctor for medical advice about side||
1865|127|S|effects. You may report side effects to Health Canada at||
1865|128|S|1-866-234-2345.||
1865|129|B|||
1865|130|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1865|131|P|pharmacist if you are allergic to emtricitabine, rilpivirine, or||
1865|132|P|tenofovir; or if you have any other allergies. This product may||
1865|133|P|contain inactive ingredients, which can cause allergic reactions||
1865|134|P|or other problems. Talk to your pharmacist for more details.||
1865|135|P|   Before using this medication, tell your doctor or pharmacist||
1865|136|P|your medical history, especially of: kidney disease, liver||
1865|137|P|disease (such as hepatitis B or C, cirrhosis), alcohol use, bone||
1865|138|P|problems (such as bone disease, bone loss/osteoporosis,||
1865|139|P|weak/broken bones), mental/mood disorders (such as depression).||
1865|140|P|   Before having surgery, tell your doctor or dentist about all||
1865|141|P|the products you use (including prescription drugs,||
1865|142|P|nonprescription drugs, and herbal products).||
1865|143|P|   During pregnancy, this medication should be used only when||
1865|144|P|clearly needed. Treatment can lower the risk of passing HIV||
1865|145|P|infection to your baby, and this medication may be part of that||
1865|146|P|treatment. Discuss the risks and benefits with your doctor.||
1865|147|P|   This medication passes into breast milk. Because breast milk||
1865|148|P|may transmit HIV, consult your doctor before breastfeeding.||
1865|149|B|||
1865|150|I|DRUG INTERACTIONS:  See also How to Use section.||
1865|151|I|   Drug interactions may change how your medications work or||
1865|152|I|increase your risk for serious side effects. This document does||
1865|153|I|not contain all possible drug interactions. Keep a list of all||
1865|154|I|the products you use (including prescription/nonprescription||
1865|155|I|drugs and herbal products) and share it with your doctor and||
1865|156|I|pharmacist. Do not start, stop, or change the dosage of any||
1865|157|I|medicines without your doctor's approval.||
1865|158|I|   Some products that may interact with this drug are: adefovir,||
1865|159|I|orlistat, other drugs that may be harmful to the kidneys||
1865|160|I|(including aminoglycosides such as amikacin/gentamicin), proton||
1865|161|I|pump inhibitors (PPIs such as dexlansoprazole, esomeprazole,||
1865|162|I|lansoprazole, omeprazole, pantoprazole, rabeprazole).||
1865|163|I|   Do not take this medication with other products that treat HIV||
1865|164|I|infection. Do not take this medication with other products that||
1865|165|I|contain emtricitabine, tenofovir, or lamivudine. In addition, do||
1865|166|I|not take this medication with other products that contain||
1865|167|I|rilpivirine, unless you are also taking rifabutin.||
1865|168|I|   Other medications can affect the removal of rilpivirine from||
1865|169|I|your body, which may affect how this medication works. Examples||
1865|170|I|include dexamethasone, macrolide antibiotics (such as||
1865|171|I|erythromycin), rifamycins (such as rifampin, rifapentine), St.||
1865|172|I|John's wort, certain drugs used to treat seizures (such as||
1865|173|I|carbamazepine, oxcarbazepine, phenobarbital, phenytoin,||
1865|174|I|primidone), telithromycin, among others.||
1865|175|B|||
1865|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1865|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1865|178|O|poison control center right away. US residents can call||
1865|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1865|180|O|Symptoms of overdose may include: fast/irregular heartbeat,||
1865|181|O|severe dizziness, fainting.||
1865|182|B|||
1865|183|N|NOTES:  Do not share this medication with others.||
1865|184|N|   Lab and/or medical tests (such as kidney/liver function, test||
1865|185|N|for hepatitis B virus, viral load, T-cell counts, blood mineral||
1865|186|N|levels, bone density tests, urine glucose/protein) should be done||
1865|187|N|before you start taking this medication and while you are taking||
1865|188|N|it. Keep all medical and lab appointments. Consult your doctor||
1865|189|N|for more details.||
1865|190|B|||
1865|191|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
1865|192|D|you remember. If it is more than 12 hours after the missed dose,||
1865|193|D|skip the missed dose. Take your next dose at the regular time. Do||
1865|194|D|not double the dose to catch up.||
1865|195|B|||
1865|196|R|STORAGE:  Store in the original bottle at room temperature away||
1865|197|R|from light and moisture. Do not store in the bathroom. Keep all||
1865|198|R|medications away from children and pets.||
1865|199|R|   Do not flush medications down the toilet or pour them into a||
1865|200|R|drain unless instructed to do so. Properly discard this product||
1865|201|R|when it is expired or no longer needed. Consult your pharmacist||
1865|202|R|or local waste disposal company.||
1865|203|B|||
1865|204|A|Information last revised June 2025.||
1865|205|A|Copyright(c) 2025 First Databank, Inc.||
1865|206|B|||
1867|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1867|002|Z|does NOT have all possible information about this product. This||
1867|003|Z|information does not assure that this product is safe, effective,||
1867|004|Z|or appropriate for you. This information is not individual||
1867|005|Z|medical advice and does not substitute for the advice of your||
1867|006|Z|health care professional. Always ask your health care||
1867|007|Z|professional for complete information about this product and your||
1867|008|Z|specific health needs.||
1867|009|B|||
1867|010|T|COPANLISIB - INJECTION||
1867|011|F|(KOE-pan-LIS-ib)||
1867|012|B|||
1867|013|C|COMMON BRAND NAME(S): Aliqopa||
1867|014|B|||
1867|015|U|USES:  This medication is used to treat a certain type of cancer||
1867|016|U|(follicular lymphoma). It works by slowing or stopping the growth||
1867|017|U|of cancer cells.||
1867|018|B|||
1867|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1867|020|H|from your pharmacist before you start using copanlisib and each||
1867|021|H|time you get a refill. If you have any questions, ask your doctor||
1867|022|H|or pharmacist.||
1867|023|H|   This medication is given by injection into a vein over 1 hour||
1867|024|H|as directed by your doctor. It is usually given once a week for 3||
1867|025|H|weeks followed by a 1-week rest period. The cycle is then||
1867|026|H|repeated as directed by your doctor. The dosage is based on your||
1867|027|H|medical condition, response to treatment, and other medications||
1867|028|H|you may be taking. Be sure to tell your doctor and pharmacist||
1867|029|H|about all the products you use (including prescription drugs,||
1867|030|H|nonprescription drugs, and herbal products).||
1867|031|H|   Use this medication regularly to get the most benefit from it.||
1867|032|H|To help you remember, mark your calendar with a reminder.||
1867|033|B|||
1867|034|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, or mouth pain/sores||
1867|035|S|may occur. If any of these effects last or get worse, tell your||
1867|036|S|doctor or pharmacist promptly.||
1867|037|S|   People using this medication may have serious side effects.||
1867|038|S|However, you have been prescribed this drug because your doctor||
1867|039|S|has judged that the benefit to you is greater than the risk of||
1867|040|S|side effects. Careful monitoring by your doctor may decrease your||
1867|041|S|risk.||
1867|042|S|   Tell your doctor right away if you have any serious side||
1867|043|S|effects, including: easy bruising/bleeding, unusual tiredness,||
1867|044|S|increased thirst/urination.||
1867|045|S|   This medication may raise your blood pressure while you are||
1867|046|S|receiving it. Your blood pressure should be checked before and||
1867|047|S|after your infusion.||
1867|048|S|   This medication may lower your ability to fight infections.||
1867|049|S|This may make you more likely to get a serious (rarely fatal)||
1867|050|S|infection or make any infection you have worse. Tell your doctor||
1867|051|S|right away if you have any signs of infection (such as sore||
1867|052|S|throat that doesn't go away, fever, chills, cough, shortness of||
1867|053|S|breath, chest pain).||
1867|054|S|   Copanlisib can commonly cause a rash that is usually not||
1867|055|S|serious. However, you may not be able to tell it apart from a||
1867|056|S|rare rash that could be a sign of a severe reaction. Get medical||
1867|057|S|help right away if you develop any rash.||
1867|058|S|   A very serious allergic reaction to this drug is rare.||
1867|059|S|However, get medical help right away if you notice any symptoms||
1867|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1867|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1867|062|S|breathing.||
1867|063|S|   This is not a complete list of possible side effects. If you||
1867|064|S|notice other effects not listed above, contact your doctor or||
1867|065|S|pharmacist.||
1867|066|S|   In the US -||
1867|067|S|   Call your doctor for medical advice about side effects. You||
1867|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1867|069|S|www.fda.gov/medwatch.||
1867|070|S|   In Canada - Call your doctor for medical advice about side||
1867|071|S|effects. You may report side effects to Health Canada at||
1867|072|S|1-866-234-2345.||
1867|073|B|||
1867|074|P|PRECAUTIONS:  Before using copanlisib, tell your doctor or||
1867|075|P|pharmacist if you are allergic to it; or if you have any other||
1867|076|P|allergies. This product may contain inactive ingredients, which||
1867|077|P|can cause allergic reactions or other problems. Talk to your||
1867|078|P|pharmacist for more details.||
1867|079|P|   Before using this medication, tell your doctor or pharmacist||
1867|080|P|your medical history, especially of: recent/current infection,||
1867|081|P|diabetes, high blood pressure, liver problems.||
1867|082|P|   Copanlisib can make you more likely to get infections or may||
1867|083|P|make current infections worse. Stay away from anyone who has an||
1867|084|P|infection that may easily spread (such as chickenpox, COVID-19,||
1867|085|P|measles, flu). Talk to your doctor if you have been exposed to an||
1867|086|P|infection or for more details.||
1867|087|P|   Tell your health care professional that you are using||
1867|088|P|copanlisib before having any immunizations/vaccinations. Avoid||
1867|089|P|contact with people who have recently received live vaccines||
1867|090|P|(such as flu vaccine inhaled through the nose).||
1867|091|P|   To lower the chance of getting cut, bruised, or injured, use||
1867|092|P|caution with sharp objects like razors and nail cutters, and||
1867|093|P|avoid activities such as contact sports.||
1867|094|P|   Before having surgery, tell your doctor or dentist about all||
1867|095|P|the products you use (including prescription drugs,||
1867|096|P|nonprescription drugs, and herbal products).||
1867|097|P|   Older adults may be more sensitive to the side effects of this||
1867|098|P|drug.||
1867|099|P|   Tell your doctor if you are pregnant or plan to become||
1867|100|P|pregnant. You should not become pregnant while using copanlisib.||
1867|101|P|Copanlisib may harm an unborn baby. Your doctor should order a||
1867|102|P|pregnancy test before you start this medication. Men and women||
1867|103|P|using this medication should ask about reliable forms of birth||
1867|104|P|control during treatment and for 1 month after the last dose. If||
1867|105|P|you or your partner becomes pregnant, talk to your doctor right||
1867|106|P|away about the risks and benefits of this medication.||
1867|107|P|   It is unknown if this drug passes into breast milk. Because of||
1867|108|P|the possible risk to the infant, breastfeeding is not recommended||
1867|109|P|while using this drug and for 1 month after the last dose.||
1867|110|P|Consult your doctor before breastfeeding.||
1867|111|B|||
1867|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1867|113|I|medications work or increase your risk for serious side effects.||
1867|114|I|This document does not contain all possible drug interactions.||
1867|115|I|Keep a list of all the products you use (including||
1867|116|I|prescription/nonprescription drugs and herbal products) and share||
1867|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
1867|118|I|the dosage of any medicines without your doctor's approval.||
1867|119|I|   Other medications can affect the removal of copanlisib from||
1867|120|I|your body, which may affect how copanlisib works. Examples||
1867|121|I|include rifamycins (such as rifabutin), St. John's wort, drugs||
1867|122|I|used to treat seizures (such as carbamazepine, phenytoin), among||
1867|123|I|others.||
1867|124|B|||
1867|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1867|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1867|127|O|poison control center right away. US residents can call||
1867|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1867|129|B|||
1867|130|N|NOTES:  Lab and/or medical tests (such as blood glucose, blood||
1867|131|N|pressure, complete blood count) should be done while you are||
1867|132|N|using this medication. Keep all medical and lab appointments.||
1867|133|N|Consult your doctor for more details.||
1867|134|B|||
1867|135|D|MISSED DOSE:  It is important to get each dose of this medication||
1867|136|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1867|137|D|right away for a new dosing schedule.||
1867|138|B|||
1867|139|R|STORAGE:  Not applicable. This medication is given in a hospital||
1867|140|R|or clinic and will not be stored at home.||
1867|141|R|   Do not flush medications down the toilet or pour them into a||
1867|142|R|drain unless instructed to do so. Properly discard this product||
1867|143|R|when it is expired or no longer needed. Consult your pharmacist||
1867|144|R|or local waste disposal company.||
1867|145|B|||
1867|146|M|MEDICAL ALERT:  Your condition can cause complications in a||
1867|147|M|medical emergency. For information about enrolling in MedicAlert,||
1867|148|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1867|149|B|||
1867|150|A|Information last revised October 2024.||
1867|151|A|Copyright(c) 2025 First Databank, Inc.||
1867|152|B|||
1868|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1868|002|Z|does NOT have all possible information about this product. This||
1868|003|Z|information does not assure that this product is safe, effective,||
1868|004|Z|or appropriate for you. This information is not individual||
1868|005|Z|medical advice and does not substitute for the advice of your||
1868|006|Z|health care professional. Always ask your health care||
1868|007|Z|professional for complete information about this product and your||
1868|008|Z|specific health needs.||
1868|009|B|||
1868|010|T|AMANTADINE EXTENDED-RELEASE - ORAL||
1868|011|F|(a-MAN-ta-deen)||
1868|012|B|||
1868|013|C|COMMON BRAND NAME(S): Gocovri, Osmolex ER||
1868|014|B|||
1868|015|U|USES:  This medication is used to treat Parkinson's disease. It||
1868|016|U|is also used to treat certain movement disorders caused by some||
1868|017|U|drugs (extrapyramidal reactions). This medication is thought to||
1868|018|U|work by restoring the balance of certain natural substances||
1868|019|U|(neurotransmitters) in the brain.||
1868|020|U|   Different brands of this medication may have different uses.||
1868|021|U|Do not change brands of this medication unless directed by your||
1868|022|U|doctor.||
1868|023|B|||
1868|024|H|HOW TO USE:  Take this medication by mouth with or without food||
1868|025|H|as directed by your doctor, usually once daily. Ask your doctor||
1868|026|H|or pharmacist when to take your medication since different brands||
1868|027|H|are taken at different times (either in the morning, or at||
1868|028|H|bedtime). Swallow this medication whole. Do not crush, chew, or||
1868|029|H|split the capsules/tablets. Doing so can release all of the drug||
1868|030|H|at once, increasing the risk of side effects.||
1868|031|H|   If you using the capsules and have trouble swallowing them||
1868|032|H|whole, you may open the capsule and sprinkle the contents on a||
1868|033|H|small amount of soft food (such as applesauce) just before||
1868|034|H|taking. Swallow the mixture right away without chewing. Do not||
1868|035|H|save it to take later.||
1868|036|H|   The dosage is based on your medical condition and response to||
1868|037|H|treatment.||
1868|038|H|   Use this medication regularly to get the most benefit from it.||
1868|039|H|To help you remember, take it at the same time each day.||
1868|040|H|   Do not stop taking this medication without consulting your||
1868|041|H|doctor. Your condition may get worse if this drug is suddenly||
1868|042|H|stopped or if your dose is quickly decreased. Your doctor may||
1868|043|H|gradually reduce your dose to lessen the chance of symptoms such||
1868|044|H|as agitation, anxiety, hallucinations, depression, or trouble||
1868|045|H|speaking. Tell your doctor right away of any new or worsening||
1868|046|H|symptoms.||
1868|047|H|   Amantadine may take several weeks to have an effect. Tell your||
1868|048|H|doctor if your condition does not get better or if it gets worse.||
1868|049|B|||
1868|050|S|SIDE EFFECTS:  Blurred vision, nausea, loss of appetite,||
1868|051|S|drowsiness, dizziness, lightheadedness, headache, dry mouth,||
1868|052|S|constipation, or trouble sleeping may occur. If any of these||
1868|053|S|effects last or get worse, tell your doctor or pharmacist||
1868|054|S|promptly.||
1868|055|S|   Dizziness and lightheadedness can increase the risk of||
1868|056|S|falling. Get up slowly when rising from a sitting or lying||
1868|057|S|position.||
1868|058|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
1868|059|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1868|060|S|substitute.||
1868|061|S|   If you are taking the extended-release tablets, an empty||
1868|062|S|tablet shell may appear in your stool. This effect is harmless||
1868|063|S|because your body has already absorbed the medication.||
1868|064|S|   Remember that this medication has been prescribed because your||
1868|065|S|doctor has judged that the benefit to you is greater than the||
1868|066|S|risk of side effects. Many people using this medication do not||
1868|067|S|have serious side effects.||
1868|068|S|   Tell your doctor right away if you have any serious side||
1868|069|S|effects, including: purplish-red blotchy spots on the skin||
1868|070|S|(especially on the legs), swelling of the ankles/feet, difficulty||
1868|071|S|urinating, vision changes (such as vision loss), eye pain,||
1868|072|S|unusual strong urges (such as increased gambling, increased||
1868|073|S|sexual urges, uncontrolled spending), mental/mood changes (such||
1868|074|S|as anxiety, depression, hallucinations, suicidal||
1868|075|S|thoughts/attempts), muscle spasms.||
1868|076|S|   Get medical help right away if you have any very serious side||
1868|077|S|effects, including: seizure.||
1868|078|S|   Some people taking amantadine have fallen asleep suddenly||
1868|079|S|during their usual daily activities (such as talking, driving).||
1868|080|S|You might fall asleep without warning or without feeling drowsy.||
1868|081|S|This effect can happen at any time even if you have used this||
1868|082|S|medication for a long time. If you have increased sleepiness or||
1868|083|S|fall asleep suddenly during the day, tell your doctor right away.||
1868|084|S|Your risk is higher if you drink alcohol or take other||
1868|085|S|medications that can make you drowsy. Do not drive or do other||
1868|086|S|activities for which you need to be alert (see also Precautions||
1868|087|S|section).||
1868|088|S|   A very serious allergic reaction to this drug is rare.||
1868|089|S|However, get medical help right away if you notice any symptoms||
1868|090|S|of a serious allergic reaction, including: rash, itching/swelling||
1868|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1868|092|S|breathing.||
1868|093|S|   This is not a complete list of possible side effects. If you||
1868|094|S|notice other effects not listed above, contact your doctor or||
1868|095|S|pharmacist.||
1868|096|S|   In the US -||
1868|097|S|   Call your doctor for medical advice about side effects. You||
1868|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1868|099|S|www.fda.gov/medwatch.||
1868|100|S|   In Canada - Call your doctor for medical advice about side||
1868|101|S|effects. You may report side effects to Health Canada at||
1868|102|S|1-866-234-2345.||
1868|103|B|||
1868|104|P|PRECAUTIONS:  Before taking amantadine, tell your doctor or||
1868|105|P|pharmacist if you are allergic to it; or to rimantadine; or if||
1868|106|P|you have any other allergies. This product may contain inactive||
1868|107|P|ingredients, which can cause allergic reactions or other||
1868|108|P|problems. Talk to your pharmacist for more details.||
1868|109|P|   Before using this medication, tell your doctor or pharmacist||
1868|110|P|your medical history, especially of: glaucoma, kidney disease,||
1868|111|P|mental/mood conditions (such as depression, psychosis), a certain||
1868|112|P|skin disorder (eczematoid dermatitis), sleep disorders (such as||
1868|113|P|narcolepsy), seizure disorder.||
1868|114|P|   This drug may make you dizzy or drowsy or blur your vision.||
1868|115|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
1868|116|P|drowsy. Do not drive, use machinery, or do anything that needs||
1868|117|P|alertness or clear vision until you can do it safely. Limit||
1868|118|P|alcoholic beverages. Talk to your doctor if you are using||
1868|119|P|marijuana (cannabis).||
1868|120|P|   Before having surgery, tell your doctor or dentist about all||
1868|121|P|the products you use (including prescription drugs,||
1868|122|P|nonprescription drugs, and herbal products).||
1868|123|P|   Older adults may be more sensitive to the side effects of this||
1868|124|P|drug, especially dizziness, lightheadedness, and mental/mood||
1868|125|P|changes (such as hallucinations). Dizziness and lightheadedness||
1868|126|P|can increase the risk of falling.||
1868|127|P|   During pregnancy, this medication should be used only when||
1868|128|P|clearly needed. Discuss the risks and benefits with your doctor.||
1868|129|P|   This drug passes into breast milk and may have undesirable||
1868|130|P|effects on a nursing infant. Consult with your doctor before||
1868|131|P|breastfeeding.||
1868|132|B|||
1868|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1868|134|I|medications work or increase your risk for serious side effects.||
1868|135|I|This document does not contain all possible drug interactions.||
1868|136|I|Keep a list of all the products you use (including||
1868|137|I|prescription/nonprescription drugs and herbal products) and share||
1868|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
1868|139|I|the dosage of any medicines without your doctor's approval.||
1868|140|I|   Amantadine may interfere with the effect of certain vaccines,||
1868|141|I|such as flu vaccine inhaled through the nose. However, you may||
1868|142|I|get a flu shot (flu vaccine given by injection) if recommended by||
1868|143|I|your doctor.||
1868|144|B|||
1868|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1868|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1868|147|O|poison control center right away. US residents can call||
1868|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1868|149|O|Symptoms of overdose may include fast/irregular heartbeat, severe||
1868|150|O|drowsiness, shortness of breath, change in the amount of urine,||
1868|151|O|mental/mood changes (such as anxiety, aggression, confusion,||
1868|152|O|hallucinations), seizure.||
1868|153|B|||
1868|154|N|NOTES:  Do not share this medication with others.||
1868|155|B|||
1868|156|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1868|157|D|next dose at the regular time. Do not double the dose to catch||
1868|158|D|up.||
1868|159|B|||
1868|160|R|STORAGE:  Store at room temperature away from light and moisture.||
1868|161|R|Do not store in the bathroom. Keep all medications away from||
1868|162|R|children and pets.||
1868|163|R|   Do not flush medications down the toilet or pour them into a||
1868|164|R|drain unless instructed to do so. Properly discard this product||
1868|165|R|when it is expired or no longer needed. Consult your pharmacist||
1868|166|R|or local waste disposal company.||
1868|167|B|||
1868|168|A|Information last revised July 2025.||
1868|169|A|Copyright(c) 2025 First Databank, Inc.||
1868|170|B|||
1869|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1869|002|Z|does NOT have all possible information about this product. This||
1869|003|Z|information does not assure that this product is safe, effective,||
1869|004|Z|or appropriate for you. This information is not individual||
1869|005|Z|medical advice and does not substitute for the advice of your||
1869|006|Z|health care professional. Always ask your health care||
1869|007|Z|professional for complete information about this product and your||
1869|008|Z|specific health needs.||
1869|009|B|||
1869|010|T|DELAFLOXACIN - ORAL||
1869|011|F|(DEL-a-FLOX-a-sin)||
1869|012|B|||
1869|013|C|COMMON BRAND NAME(S): Baxdela||
1869|014|B|||
1869|015|W|WARNING:  Quinolone antibiotics (including delafloxacin) may||
1869|016|W|cause serious and possibly permanent tendon damage (such as||
1869|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
1869|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
1869|019|W|help right away if you have any of the following symptoms:||
1869|020|W|pain/numbness/burning/tingling/weakness in your||
1869|021|W|arms/hands/legs/feet, changes in how you sense||
1869|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
1869|023|W|headache, vision changes, shaking (tremors), seizures,||
1869|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
1869|025|W|hallucinations, depression, rare thoughts of suicide).||
1869|026|W|   Tendon damage may occur during or after treatment with this||
1869|027|W|medication. Stop exercising, rest, and get medical help right||
1869|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
1869|029|W|risk for tendon problems is greater if you are over 60 years of||
1869|030|W|age, if you are taking corticosteroids (such as prednisone), or||
1869|031|W|if you have a kidney, heart, or lung transplant.||
1869|032|W|   This medication may make a certain muscle condition||
1869|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
1869|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
1869|035|W|unsteady walk) or trouble breathing.||
1869|036|W|   Discuss the risks and benefits with your doctor before using||
1869|037|W|this medication.||
1869|038|B|||
1869|039|U|USES:  Delafloxacin is used to treat a variety of bacterial||
1869|040|U|infections. This medication belongs to a class of drugs known as||
1869|041|U|quinolone antibiotics. It works by stopping the growth of||
1869|042|U|bacteria.||
1869|043|U|   This antibiotic treats only bacterial infections. It will not||
1869|044|U|work for viral infections (such as common cold, flu). Using any||
1869|045|U|antibiotic when it is not needed can cause it to not work for||
1869|046|U|future infections.||
1869|047|B|||
1869|048|H|HOW TO USE:  Read the Medication Guide provided by your||
1869|049|H|pharmacist before you start taking delafloxacin and each time you||
1869|050|H|get a refill. If you have any questions, ask your doctor or||
1869|051|H|pharmacist.||
1869|052|H|   Take this medication by mouth with or without food as directed||
1869|053|H|by your doctor, usually every 12 hours. Drink plenty of fluids||
1869|054|H|while taking this medication unless otherwise directed by your||
1869|055|H|doctor.||
1869|056|H|   Take this medication at least 2 hours before or 6 hours after||
1869|057|H|taking other products that may make it work less well. Examples||
1869|058|H|include quinapril, sucralfate, vitamins/minerals (including iron,||
1869|059|H|zinc), and products that contain magnesium, aluminum, or calcium||
1869|060|H|(such as antacids, juice with added calcium), among others. Ask||
1869|061|H|your pharmacist about all the products you take.||
1869|062|H|   The dosage and length of treatment are based on your medical||
1869|063|H|condition and response to treatment.||
1869|064|H|   For the best effect, take this antibiotic at evenly spaced||
1869|065|H|times. To help you remember, take this medication at the same||
1869|066|H|times every day.||
1869|067|H|   Continue to take this medication until the full prescribed||
1869|068|H|amount is finished, even if symptoms disappear after a few days.||
1869|069|H|Stopping the medication too early may result in a return of the||
1869|070|H|infection.||
1869|071|H|   Tell your doctor if your condition lasts or gets worse.||
1869|072|B|||
1869|073|S|SIDE EFFECTS:  See also Warning section.||
1869|074|S|   Nausea, diarrhea, dizziness, or lightheadedness may occur. If||
1869|075|S|any of these effects last or get worse, tell your doctor or||
1869|076|S|pharmacist promptly.||
1869|077|S|   Remember that this medication has been prescribed because your||
1869|078|S|doctor has judged that the benefit to you is greater than the||
1869|079|S|risk of side effects. Many people using this medication do not||
1869|080|S|have serious side effects.||
1869|081|S|   This medication may rarely cause a severe intestinal condition||
1869|082|S|due to a bacteria called C. difficile. This condition may occur||
1869|083|S|during treatment or weeks to months after treatment has stopped.||
1869|084|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1869|085|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1869|086|S|stool.||
1869|087|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1869|088|S|products because they may make symptoms worse.||
1869|089|S|   Use of this medication for prolonged or repeated periods may||
1869|090|S|result in oral thrush or a new yeast infection. Contact your||
1869|091|S|doctor if you notice white patches in your mouth, a change in||
1869|092|S|vaginal discharge, or other new symptoms.||
1869|093|S|   Get medical help right away if you have any very serious side||
1869|094|S|effects, including: signs of a tear/break in the main blood||
1869|095|S|vessel called the aorta (such as sudden/severe pain in the||
1869|096|S|stomach/chest/back, shortness of breath).||
1869|097|S|   A very serious allergic reaction to this drug is rare.||
1869|098|S|However, get medical help right away if you notice any symptoms||
1869|099|S|of a serious allergic reaction, including: rash, itching/swelling||
1869|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1869|101|S|breathing.||
1869|102|S|   This is not a complete list of possible side effects. If you||
1869|103|S|notice other effects not listed above, contact your doctor or||
1869|104|S|pharmacist.||
1869|105|S|   In the US -||
1869|106|S|   Call your doctor for medical advice about side effects. You||
1869|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1869|108|S|www.fda.gov/medwatch.||
1869|109|S|   In Canada - Call your doctor for medical advice about side||
1869|110|S|effects. You may report side effects to Health Canada at||
1869|111|S|1-866-234-2345.||
1869|112|B|||
1869|113|P|PRECAUTIONS:  Before taking delafloxacin, tell your doctor or||
1869|114|P|pharmacist if you are allergic to it; or to other quinolone||
1869|115|P|antibiotics (such as ciprofloxacin, moxifloxacin, ofloxacin); or||
1869|116|P|if you have any other allergies. This product may contain||
1869|117|P|inactive ingredients, which can cause allergic reactions or other||
1869|118|P|problems. Talk to your pharmacist for more details.||
1869|119|P|   Before using this medication, tell your doctor or pharmacist||
1869|120|P|your medical history, especially of: joint/tendon problems (such||
1869|121|P|as tendonitis, bursitis), kidney disease, mental/mood disorders||
1869|122|P|(such as depression), a certain muscle condition (myasthenia||
1869|123|P|gravis), nerve problems (such as peripheral neuropathy),||
1869|124|P|seizures, blood vessel problems (such as aneurysm or blockage of||
1869|125|P|the aorta or other blood vessels, hardening of the arteries),||
1869|126|P|high blood pressure, certain genetic conditions (Marfan syndrome,||
1869|127|P|Ehlers-Danlos syndrome).||
1869|128|P|   This medication may rarely cause serious changes in blood||
1869|129|P|sugar, especially if you have diabetes. Check your blood sugar||
1869|130|P|regularly as directed and share the results with your doctor.||
1869|131|P|Watch for symptoms of high blood sugar, such as increased||
1869|132|P|thirst/urination. Also watch for symptoms of low blood sugar such||
1869|133|P|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
1869|134|P|vision, dizziness, or tingling hands/feet. It is a good habit to||
1869|135|P|carry glucose tablets or gel to treat low blood sugar. If you||
1869|136|P|don't have these reliable forms of glucose, rapidly raise your||
1869|137|P|blood sugar by eating a quick source of sugar such as table||
1869|138|P|sugar, honey, or candy, or by drinking fruit juice or non-diet||
1869|139|P|soda. Tell your doctor right away about the reaction and the use||
1869|140|P|of this product. To help prevent low blood sugar, eat meals on a||
1869|141|P|regular schedule, and do not skip meals. Your doctor may need to||
1869|142|P|switch you to another antibiotic or adjust your diabetes||
1869|143|P|medications if any reaction occurs.||
1869|144|P|   This drug may make you dizzy or lightheaded. Alcohol or||
1869|145|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
1869|146|P|machinery, or do anything that needs alertness until you can do||
1869|147|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1869|148|P|are using marijuana (cannabis).||
1869|149|P|   Delafloxacin may cause live bacterial vaccines (such as||
1869|150|P|typhoid vaccine) to not work well. Tell your health care||
1869|151|P|professional that you are using delafloxacin before having any||
1869|152|P|immunizations/vaccinations.||
1869|153|P|   Before having surgery, tell your doctor or dentist about all||
1869|154|P|the products you use (including prescription drugs,||
1869|155|P|nonprescription drugs, and herbal products).||
1869|156|P|   Older adults may be at greater risk for tendon problems||
1869|157|P|(especially if they are also taking corticosteroids such as||
1869|158|P|prednisone or hydrocortisone) and a sudden tear/break in the main||
1869|159|P|blood vessel (aorta).||
1869|160|P|   During pregnancy, this medication should be used only when||
1869|161|P|clearly needed. Discuss the risks and benefits with your doctor.||
1869|162|P|   It is unknown if this medication passes into breast milk.||
1869|163|P|Consult your doctor before breastfeeding.||
1869|164|B|||
1869|165|I|DRUG INTERACTIONS:  See also How to Use section.||
1869|166|I|   Drug interactions may change how your medications work or||
1869|167|I|increase your risk for serious side effects. This document does||
1869|168|I|not contain all possible drug interactions. Keep a list of all||
1869|169|I|the products you use (including prescription/nonprescription||
1869|170|I|drugs and herbal products) and share it with your doctor and||
1869|171|I|pharmacist. Do not start, stop, or change the dosage of any||
1869|172|I|medicines without your doctor's approval.||
1869|173|I|   A product that may interact with this drug is: strontium.||
1869|174|B|||
1869|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1869|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1869|177|O|poison control center right away. US residents can call||
1869|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1869|179|B|||
1869|180|N|NOTES:  Do not share this medication with others.||
1869|181|N|   This medication has been prescribed for your current condition||
1869|182|N|only. Do not use it later for another infection unless your||
1869|183|N|doctor tells you to.||
1869|184|N|   Lab tests (such as kidney function, complete blood count,||
1869|185|N|cultures) may be done before you start taking this medication and||
1869|186|N|while you are taking it. Keep all medical and lab appointments.||
1869|187|B|||
1869|188|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1869|189|D|remember. If it is more than 4 hours after the missed dose, skip||
1869|190|D|the missed dose. Take your next dose at the regular time. Do not||
1869|191|D|double the dose to catch up.||
1869|192|B|||
1869|193|R|STORAGE:  Store at room temperature away from light and moisture.||
1869|194|R|Do not store in the bathroom. Keep all medications away from||
1869|195|R|children and pets.||
1869|196|R|   Do not flush medications down the toilet or pour them into a||
1869|197|R|drain unless instructed to do so. Properly discard this product||
1869|198|R|when it is expired or no longer needed. Consult your pharmacist||
1869|199|R|or local waste disposal company.||
1869|200|B|||
1869|201|A|Information last revised September 2025.||
1869|202|A|Copyright(c) 2025 First Databank, Inc.||
1869|203|B|||
1870|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1870|002|Z|does NOT have all possible information about this product. This||
1870|003|Z|information does not assure that this product is safe, effective,||
1870|004|Z|or appropriate for you. This information is not individual||
1870|005|Z|medical advice and does not substitute for the advice of your||
1870|006|Z|health care professional. Always ask your health care||
1870|007|Z|professional for complete information about this product and your||
1870|008|Z|specific health needs.||
1870|009|B|||
1870|010|T|DELAFLOXACIN - INJECTION||
1870|011|F|(DEL-a-FLOX-a-sin)||
1870|012|B|||
1870|013|C|COMMON BRAND NAME(S): Baxdela||
1870|014|B|||
1870|015|W|WARNING:  Quinolone antibiotics (including delafloxacin) may||
1870|016|W|cause serious and possibly permanent tendon damage (such as||
1870|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
1870|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
1870|019|W|help right away if you have any of the following symptoms:||
1870|020|W|pain/numbness/burning/tingling/weakness in your||
1870|021|W|arms/hands/legs/feet, changes in how you sense||
1870|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
1870|023|W|headache, vision changes, shaking (tremors), seizures,||
1870|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
1870|025|W|hallucinations, depression, rare thoughts of suicide).||
1870|026|W|   Tendon damage may occur during or after treatment with this||
1870|027|W|medication. Stop exercising, rest, and get medical help right||
1870|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
1870|029|W|risk for tendon problems is greater if you are over 60 years of||
1870|030|W|age, if you are taking corticosteroids (such as prednisone), or||
1870|031|W|if you have a kidney, heart, or lung transplant.||
1870|032|W|   This medication may make a certain muscle condition||
1870|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
1870|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
1870|035|W|unsteady walk) or trouble breathing.||
1870|036|W|   Discuss the risks and benefits with your doctor before using||
1870|037|W|this medication.||
1870|038|B|||
1870|039|U|USES:  Delafloxacin is used to treat a variety of bacterial||
1870|040|U|infections. This medication belongs to a class of drugs known as||
1870|041|U|quinolone antibiotics. It works by stopping the growth of||
1870|042|U|bacteria. Delafloxacin injection is used if you cannot take the||
1870|043|U|medication by mouth.||
1870|044|B|||
1870|045|H|HOW TO USE:  Read the Medication Guide provided by your||
1870|046|H|pharmacist before you start using delafloxacin and each time you||
1870|047|H|get a refill. If you have any questions, ask your doctor or||
1870|048|H|pharmacist.||
1870|049|H|   If you are using this medication at home, learn all||
1870|050|H|preparation and usage instructions from your health care||
1870|051|H|professional. Before using, check this product for particles or||
1870|052|H|discoloration. If either is present, do not use the liquid. Learn||
1870|053|H|how to store and discard medical supplies safely.||
1870|054|H|   This medication is given by injection into a vein, as directed||
1870|055|H|by your doctor, usually every 12 hours over 60 minutes. The||
1870|056|H|dosage and length of treatment are based on your medical||
1870|057|H|condition and response to treatment.||
1870|058|H|   Drink plenty of fluids while using this medication unless||
1870|059|H|otherwise directed by your doctor.||
1870|060|H|   For the best effect, use this antibiotic at evenly spaced||
1870|061|H|times. To help you remember, use this medication at the same||
1870|062|H|times every day.||
1870|063|H|   Continue to use this medication until the full prescribed||
1870|064|H|amount is finished, even if symptoms disappear after a few days.||
1870|065|H|Stopping the medication too early may result in a return of the||
1870|066|H|infection.||
1870|067|H|   Tell your doctor if your condition lasts or gets worse.||
1870|068|B|||
1870|069|S|SIDE EFFECTS:  See also Warning section.||
1870|070|S|   Pain/redness/swelling at the injection site, nausea, diarrhea,||
1870|071|S|dizziness, or lightheadedness may occur. If any of these effects||
1870|072|S|last or get worse, tell your doctor or pharmacist promptly.||
1870|073|S|   Remember that this medication has been prescribed because your||
1870|074|S|doctor has judged that the benefit to you is greater than the||
1870|075|S|risk of side effects. Many people using this medication do not||
1870|076|S|have serious side effects.||
1870|077|S|   This medication may rarely cause a severe intestinal condition||
1870|078|S|due to a bacteria called C. difficile. This condition may occur||
1870|079|S|during treatment or weeks to months after treatment has stopped.||
1870|080|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1870|081|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1870|082|S|stool.||
1870|083|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1870|084|S|products because they may make symptoms worse.||
1870|085|S|   Use of this medication for prolonged or repeated periods may||
1870|086|S|result in oral thrush or a new yeast infection. Contact your||
1870|087|S|doctor if you notice white patches in your mouth, a change in||
1870|088|S|vaginal discharge, or other new symptoms.||
1870|089|S|   Get medical help right away if you have any very serious side||
1870|090|S|effects, including: signs of a tear/break in the main blood||
1870|091|S|vessel called the aorta (such as sudden/severe pain in the||
1870|092|S|stomach/chest/back, shortness of breath).||
1870|093|S|   A very serious allergic reaction to this drug is rare.||
1870|094|S|However, get medical help right away if you notice any symptoms||
1870|095|S|of a serious allergic reaction, including: rash, itching/swelling||
1870|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1870|097|S|breathing.||
1870|098|S|   This is not a complete list of possible side effects. If you||
1870|099|S|notice other effects not listed above, contact your doctor or||
1870|100|S|pharmacist.||
1870|101|S|   In the US -||
1870|102|S|   Call your doctor for medical advice about side effects. You||
1870|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1870|104|S|www.fda.gov/medwatch.||
1870|105|S|   In Canada - Call your doctor for medical advice about side||
1870|106|S|effects. You may report side effects to Health Canada at||
1870|107|S|1-866-234-2345.||
1870|108|B|||
1870|109|P|PRECAUTIONS:  Before using delafloxacin, tell your doctor or||
1870|110|P|pharmacist if you are allergic to it; or to other quinolone||
1870|111|P|antibiotics (such as ciprofloxacin, moxifloxacin, ofloxacin); or||
1870|112|P|if you have any other allergies. This product may contain||
1870|113|P|inactive ingredients, which can cause allergic reactions or other||
1870|114|P|problems. Talk to your pharmacist for more details.||
1870|115|P|   Before using this medication, tell your doctor or pharmacist||
1870|116|P|your medical history, especially of: joint/tendon problems (such||
1870|117|P|as tendonitis, bursitis), kidney disease, mental/mood disorders||
1870|118|P|(such as depression), a certain muscle condition (myasthenia||
1870|119|P|gravis), nerve problems (such as peripheral neuropathy),||
1870|120|P|seizures, blood vessel problems (such as aneurysm or blockage of||
1870|121|P|the aorta or other blood vessels, hardening of the arteries),||
1870|122|P|high blood pressure, certain genetic conditions (Marfan syndrome,||
1870|123|P|Ehlers-Danlos syndrome).||
1870|124|P|   This medication may rarely cause serious changes in blood||
1870|125|P|sugar, especially if you have diabetes. Check your blood sugar||
1870|126|P|regularly as directed and share the results with your doctor.||
1870|127|P|Watch for symptoms of high blood sugar, such as increased||
1870|128|P|thirst/urination. Also watch for symptoms of low blood sugar such||
1870|129|P|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
1870|130|P|vision, dizziness, or tingling hands/feet. It is a good habit to||
1870|131|P|carry glucose tablets or gel to treat low blood sugar. If you||
1870|132|P|don't have these reliable forms of glucose, rapidly raise your||
1870|133|P|blood sugar by eating a quick source of sugar such as table||
1870|134|P|sugar, honey, or candy, or by drinking fruit juice or non-diet||
1870|135|P|soda. Tell your doctor right away about the reaction and the use||
1870|136|P|of this product. To help prevent low blood sugar, eat meals on a||
1870|137|P|regular schedule, and do not skip meals. Your doctor may need to||
1870|138|P|switch you to another antibiotic or adjust your diabetes||
1870|139|P|medications if any reaction occurs.||
1870|140|P|   This drug may make you dizzy or lightheaded. Alcohol or||
1870|141|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
1870|142|P|machinery, or do anything that needs alertness until you can do||
1870|143|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1870|144|P|are using marijuana (cannabis).||
1870|145|P|   Delafloxacin may cause live bacterial vaccines (such as||
1870|146|P|typhoid vaccine) to not work well. Tell your health care||
1870|147|P|professional that you are using delafloxacin before having any||
1870|148|P|immunizations/vaccinations.||
1870|149|P|   Before having surgery, tell your doctor or dentist about all||
1870|150|P|the products you use (including prescription drugs,||
1870|151|P|nonprescription drugs, and herbal products).||
1870|152|P|   Older adults may be at greater risk for tendon problems||
1870|153|P|(especially if they are also taking corticosteroids such as||
1870|154|P|prednisone or hydrocortisone) and a sudden tear/break in the main||
1870|155|P|blood vessel (aorta).||
1870|156|P|   During pregnancy, this medication should be used only when||
1870|157|P|clearly needed. Discuss the risks and benefits with your doctor.||
1870|158|P|   It is unknown if this medication passes into breast milk.||
1870|159|P|Consult your doctor before breastfeeding.||
1870|160|B|||
1870|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1870|162|I|medications work or increase your risk for serious side effects.||
1870|163|I|This document does not contain all possible drug interactions.||
1870|164|I|Keep a list of all the products you use (including||
1870|165|I|prescription/nonprescription drugs and herbal products) and share||
1870|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
1870|167|I|the dosage of any medicines without your doctor's approval.||
1870|168|B|||
1870|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1870|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1870|171|O|poison control center right away. US residents can call||
1870|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1870|173|B|||
1870|174|N|NOTES:  Lab tests (such as kidney function, complete blood count,||
1870|175|N|cultures) may be done before you start using this medication and||
1870|176|N|while you are using it. Keep all medical and lab appointments.||
1870|177|B|||
1870|178|D|MISSED DOSE:  It is important to get each dose of this medication||
1870|179|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1870|180|D|right away for a new dosing schedule. Do not double the dose to||
1870|181|D|catch up.||
1870|182|B|||
1870|183|R|STORAGE:  Consult the product instructions and your pharmacist||
1870|184|R|for storage details. Keep all medications away from children and||
1870|185|R|pets.||
1870|186|R|   Do not flush medications down the toilet or pour them into a||
1870|187|R|drain unless instructed to do so. Properly discard this product||
1870|188|R|when it is expired or no longer needed. Consult your pharmacist||
1870|189|R|or local waste disposal company.||
1870|190|B|||
1870|191|A|Information last revised December 2024.||
1870|192|A|Copyright(c) 2025 First Databank, Inc.||
1870|193|B|||
1871|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1871|002|Z|does NOT have all possible information about this product. This||
1871|003|Z|information does not assure that this product is safe, effective,||
1871|004|Z|or appropriate for you. This information is not individual||
1871|005|Z|medical advice and does not substitute for the advice of your||
1871|006|Z|health care professional. Always ask your health care||
1871|007|Z|professional for complete information about this product and your||
1871|008|Z|specific health needs.||
1871|009|B|||
1871|010|T|FLUTICASONE/UMECLIDINIUM/VILANTEROL POWDER - ORAL INHALATION||
1871|011|F|(floo-TIK-a-sone/ue-ME-kli-DIN-ee-um/vye-LAN-ter-ol)||
1871|012|B|||
1871|013|C|COMMON BRAND NAME(S): Trelegy Ellipta||
1871|014|B|||
1871|015|U|USES:  This product is used to control and prevent symptoms (such||
1871|016|U|as wheezing and shortness of breath) caused by asthma and ongoing||
1871|017|U|lung disease (chronic obstructive pulmonary disease-COPD, which||
1871|018|U|includes chronic bronchitis and emphysema). Controlling symptoms||
1871|019|U|of breathing problems helps you stay active. This inhaler||
1871|020|U|contains 3 medications: fluticasone, umeclidinium, and||
1871|021|U|vilanterol. Fluticasone belongs to a class of drugs known as||
1871|022|U|corticosteroids. It works by reducing swelling of the airways in||
1871|023|U|the lungs to make breathing easier. Umeclidinium belongs to a||
1871|024|U|class of drugs known as anticholinergics and vilanterol is a LABA||
1871|025|U|medication. Both drugs work by relaxing the muscles around the||
1871|026|U|airways so that they open up and you can breathe more easily.||
1871|027|U|Both drugs are also known as bronchodilators.||
1871|028|U|   When used alone, long-acting beta agonists (such as||
1871|029|U|vilanterol) may rarely increase the risk of serious (sometimes||
1871|030|U|fatal) asthma-related breathing problems. However, combination||
1871|031|U|products containing both an inhaled corticosteroid and||
1871|032|U|long-acting beta agonist, such as this product, do not increase||
1871|033|U|the risk of serious asthma-related breathing problems. For asthma||
1871|034|U|treatment, this product should be used when breathing problems||
1871|035|U|are not well controlled with two asthma-control medications (such||
1871|036|U|as inhaled corticosteroid and long-acting beta agonist) or if||
1871|037|U|your symptoms need combination treatment.||
1871|038|U|   This medication must be used regularly to be effective. It||
1871|039|U|does not work right away and should not be used to relieve sudden||
1871|040|U|shortness of breath. If sudden breathing problems occur, use your||
1871|041|U|quick-relief inhaler as prescribed.||
1871|042|B|||
1871|043|H|HOW TO USE:  Read the Patient Information Leaflet and||
1871|044|H|Instructions for Use provided by your pharmacist before you start||
1871|045|H|using this medication and each time you get a refill. Follow the||
1871|046|H|illustrated directions for the proper use of this medication. If||
1871|047|H|you have any questions, ask your doctor or pharmacist.||
1871|048|H|   Inhale this medication by mouth as directed by your doctor,||
1871|049|H|usually once daily. Do not open the cover of the inhaler until||
1871|050|H|you are ready to use it. Each time you open the cover, you||
1871|051|H|prepare a dose of the medication. If you open and close the cover||
1871|052|H|without inhaling the medication, you will lose the dose. To avoid||
1871|053|H|wasting a dose, do not close the cover until after you have||
1871|054|H|inhaled the medication. You may or may not taste/feel the drug||
1871|055|H|when you inhale. Do not exhale into the device.||
1871|056|H|   Use this medication regularly to get the most benefit from it.||
1871|057|H|To help you remember, use it at the same time every day. Do not||
1871|058|H|use it more than one time each day.||
1871|059|H|   Do not increase your dose, use this medication more often, or||
1871|060|H|stop using it without first consulting your doctor. Your||
1871|061|H|condition will not improve any faster, and your risk of side||
1871|062|H|effects will increase.||
1871|063|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
1871|064|H|from developing, gargle, rinse your mouth with water and spit out||
1871|065|H|after each use. Do not swallow the rinse water.||
1871|066|H|   If you are using other inhalers at the same time, wait at||
1871|067|H|least 1 minute between the use of each medication.||
1871|068|H|   If you have been using a quick-relief inhaler (such as||
1871|069|H|albuterol, also called salbutamol in some countries) on a regular||
1871|070|H|daily schedule (such as 4 times daily), you must stop this||
1871|071|H|schedule and only use the quick-relief inhaler as needed for||
1871|072|H|sudden shortness of breath. Consult your doctor for details.||
1871|073|H|   Learn which of your inhalers you should use every day and||
1871|074|H|which you should use if your breathing suddenly worsens||
1871|075|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1871|076|H|should do if you have new or worsening cough or shortness of||
1871|077|H|breath, wheezing, increased sputum, waking up at night with||
1871|078|H|trouble breathing, if you use your quick-relief inhaler more||
1871|079|H|often, or if your quick-relief inhaler does not seem to be||
1871|080|H|working well. Learn when you can treat sudden breathing problems||
1871|081|H|by yourself and when you must get medical help right away.||
1871|082|H|   If you are regularly taking corticosteroids by mouth (such as||
1871|083|H|prednisone), continue to follow your doctor's instructions on||
1871|084|H|taking them. Do not stop taking them. Your doctor may want you to||
1871|085|H|reduce your dose gradually.||
1871|086|H|   Tell your doctor if your condition does not get better or if||
1871|087|H|it gets worse.||
1871|088|B|||
1871|089|S|SIDE EFFECTS:  Dry/irritated throat, hoarseness, or coughing may||
1871|090|S|occur as your body adjusts to the medication. If any of these||
1871|091|S|effects last or get worse, tell your doctor or pharmacist||
1871|092|S|promptly.||
1871|093|S|   Remember that this medication has been prescribed because your||
1871|094|S|doctor has judged that the benefit to you is greater than the||
1871|095|S|risk of side effects. Many people using this medication do not||
1871|096|S|have serious side effects.||
1871|097|S|   Tell your doctor right away if you have any serious side||
1871|098|S|effects, including: white patches in your mouth or on your||
1871|099|S|tongue, signs of infection (such as sore throat that doesn't go||
1871|100|S|away, fever, chills), increased thirst/urination, bone pain,||
1871|101|S|difficult/painful urination, shaking (tremor), muscle||
1871|102|S|cramps/weakness, mental/mood changes (such as depression, mood||
1871|103|S|swings, nervousness, agitation), easy bruising/bleeding.||
1871|104|S|   This medication may raise your blood pressure. Check your||
1871|105|S|blood pressure regularly and tell your doctor if the results are||
1871|106|S|high.||
1871|107|S|   Rarely, this medication may cause sudden, severe||
1871|108|S|wheezing/trouble breathing immediately after you use it. If this||
1871|109|S|happens, use your quick-relief inhaler and get medical help right||
1871|110|S|away.||
1871|111|S|   Get medical help right away if you have any very serious side||
1871|112|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1871|113|S|dizziness, fainting, eye pain/swelling/redness, vision changes||
1871|114|S|(such as seeing rainbows around lights at night, blurred vision).||
1871|115|S|   A very serious allergic reaction to this drug is rare.||
1871|116|S|However, get medical help right away if you notice any symptoms||
1871|117|S|of a serious allergic reaction, including: rash, itching/swelling||
1871|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1871|119|S|breathing.||
1871|120|S|   This is not a complete list of possible side effects. If you||
1871|121|S|notice other effects not listed above, contact your doctor or||
1871|122|S|pharmacist.||
1871|123|S|   In the US -||
1871|124|S|   Call your doctor for medical advice about side effects. You||
1871|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1871|126|S|www.fda.gov/medwatch.||
1871|127|S|   In Canada - Call your doctor for medical advice about side||
1871|128|S|effects. You may report side effects to Health Canada at||
1871|129|S|1-866-234-2345.||
1871|130|B|||
1871|131|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1871|132|P|pharmacist if you are allergic to fluticasone, umeclidinium, or||
1871|133|P|vilanterol, or if you have any other allergies. This product may||
1871|134|P|contain inactive ingredients (such as milk proteins), which can||
1871|135|P|cause allergic reactions or other problems. Talk to your||
1871|136|P|pharmacist for more details.||
1871|137|P|   Before using this medication, tell your doctor or pharmacist||
1871|138|P|your medical history, especially of: current/past infections||
1871|139|P|(such as tuberculosis, herpes), heart problems (such as chest||
1871|140|P|pain, irregular heartbeat), high blood pressure, bone loss||
1871|141|P|(osteoporosis), personal or family history of eye problems (such||
1871|142|P|as cataracts, glaucoma), difficulty urinating (such as due to an||
1871|143|P|enlarged prostate), seizures, overactive thyroid, diabetes, liver||
1871|144|P|disease.||
1871|145|P|   This product may cause a condition that affects the heart||
1871|146|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1871|147|P|serious (rarely fatal) fast/irregular heartbeat and other||
1871|148|P|symptoms (such as severe dizziness, fainting) that need medical||
1871|149|P|attention right away.||
1871|150|P|   The risk of QT prolongation may be increased if you have||
1871|151|P|certain medical conditions or are taking other drugs that may||
1871|152|P|cause QT prolongation. Before using this product, tell your||
1871|153|P|doctor or pharmacist of all the drugs you take and if you have||
1871|154|P|any of the following conditions: certain heart problems (heart||
1871|155|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1871|156|P|history of certain heart problems (QT prolongation in the EKG,||
1871|157|P|sudden cardiac death).||
1871|158|P|   Low levels of potassium or magnesium in the blood may also||
1871|159|P|increase your risk of QT prolongation. This risk may increase if||
1871|160|P|you use certain drugs (such as diuretics/"water pills") or if you||
1871|161|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1871|162|P|Talk to your doctor about using this product safely.||
1871|163|P|   This product can make you more likely to get infections or may||
1871|164|P|make current infections worse. Stay away from anyone who has an||
1871|165|P|infection that may easily spread (such as chickenpox, COVID-19,||
1871|166|P|measles, flu). Talk to your doctor if you have been exposed to an||
1871|167|P|infection or for more details.||
1871|168|P|   If you have switched from a corticosteroid taken by mouth||
1871|169|P|(such as prednisone tablets) to this inhaler within the past 12||
1871|170|P|months, or if you have been using this product in||
1871|171|P|higher-than-usual doses for a long time, it may be more difficult||
1871|172|P|for your body to respond to physical stress. Before having||
1871|173|P|surgery or emergency treatment, or if you get a serious||
1871|174|P|illness/injury, tell your doctor or dentist that you are using||
1871|175|P|this medication or have used a corticosteroid taken by mouth||
1871|176|P|within the past 12 months. Tell your doctor right away if you||
1871|177|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
1871|178|P|card or medical ID bracelet that says you use (or have used)||
1871|179|P|corticosteroid medications.||
1871|180|P|   Before having surgery, tell your doctor or dentist about all||
1871|181|P|the products you use (including prescription drugs,||
1871|182|P|nonprescription drugs, and herbal products).||
1871|183|P|   This medication may temporarily slow down a child's growth if||
1871|184|P|used for a long time. However, poorly controlled asthma can also||
1871|185|P|slow down growth. See the doctor regularly so your child's height||
1871|186|P|can be checked.||
1871|187|P|   Older adults may be more sensitive to the side effects of this||
1871|188|P|drug, especially QT prolongation (see above).||
1871|189|P|   During pregnancy, this medication should be used only when||
1871|190|P|clearly needed. Discuss the risks and benefits with your doctor.||
1871|191|P|   It is unknown if this medication passes into breast milk.||
1871|192|P|Consult your doctor before breastfeeding.||
1871|193|B|||
1871|194|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1871|195|I|medications work or increase your risk for serious side effects.||
1871|196|I|This document does not contain all possible drug interactions.||
1871|197|I|Keep a list of all the products you use (including||
1871|198|I|prescription/nonprescription drugs and herbal products) and share||
1871|199|I|it with your doctor and pharmacist. Do not start, stop, or change||
1871|200|I|the dosage of any medicines without your doctor's approval.||
1871|201|I|   A product that may interact with this drug is: desmopressin.||
1871|202|I|   Other medications can affect the removal of fluticasone from||
1871|203|I|your body, which may affect how fluticasone works. Examples||
1871|204|I|include some azole antifungals (such as ketoconazole), HIV||
1871|205|I|protease inhibitors (such as lopinavir), ritonavir, among others.||
1871|206|I|   Do not use other LABA drugs (such as formoterol, salmeterol)||
1871|207|I|while using this medication.||
1871|208|B|||
1871|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1871|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1871|211|O|poison control center right away. US residents can call||
1871|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1871|213|O|Symptoms of overdose may include: shaking (tremor), chest pain,||
1871|214|O|fast/irregular heartbeat, seizures.||
1871|215|B|||
1871|216|N|NOTES:  Do not share this medication with others.||
1871|217|N|   Lab and/or medical tests (such as cortisol levels, lung||
1871|218|N|function, blood pressure, pulse/heart rate, eye exams) should be||
1871|219|N|done while you are using this medication. Keep all medical and||
1871|220|N|lab appointments. Consult your doctor for more details.||
1871|221|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
1871|222|N|mold that can worsen breathing problems. Because the flu virus||
1871|223|N|can also worsen breathing problems, ask your doctor or pharmacist||
1871|224|N|if you should have a flu shot every year.||
1871|225|N|   This medication may cause bone loss (osteoporosis) in adults||
1871|226|N|when used for a long time. Lifestyle changes that may help reduce||
1871|227|N|the risk of bone problems include doing weight-bearing exercise,||
1871|228|N|stopping smoking, limiting alcohol, and getting enough calcium||
1871|229|N|and vitamin D. Talk to your doctor for more details.||
1871|230|B|||
1871|231|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1871|232|D|If it is near the time of the next dose, skip the missed dose.||
1871|233|D|Use your next dose at the regular time. Do not double the dose to||
1871|234|D|catch up. Do not use more than one dose each day.||
1871|235|B|||
1871|236|R|STORAGE:  Store at room temperature away from light, heat, and||
1871|237|R|moisture. Do not store in the bathroom. Do not open the sealed||
1871|238|R|tray until you are ready to use the new inhaler. Once the inhaler||
1871|239|R|is removed from the tray, this medication expires after 6 weeks.||
1871|240|R|Keep all medications away from children and pets.||
1871|241|R|   Do not flush medications down the toilet or pour them into a||
1871|242|R|drain unless instructed to do so. Properly discard this product||
1871|243|R|when it is expired or no longer needed. Consult your pharmacist||
1871|244|R|or local waste disposal company.||
1871|245|B|||
1871|246|M|MEDICAL ALERT:  Your condition can cause complications in a||
1871|247|M|medical emergency. For information about enrolling in MedicAlert,||
1871|248|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1871|249|B|||
1871|250|A|Information last revised September 2025.||
1871|251|A|Copyright(c) 2025 First Databank, Inc.||
1871|252|B|||
1872|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1872|002|Z|does NOT have all possible information about this product. This||
1872|003|Z|information does not assure that this product is safe, effective,||
1872|004|Z|or appropriate for you. This information is not individual||
1872|005|Z|medical advice and does not substitute for the advice of your||
1872|006|Z|health care professional. Always ask your health care||
1872|007|Z|professional for complete information about this product and your||
1872|008|Z|specific health needs.||
1872|009|B|||
1872|010|T|NALDEMEDINE - ORAL||
1872|011|F|(nal-DEM-e-deen)||
1872|012|B|||
1872|013|C|COMMON BRAND NAME(S): Symproic||
1872|014|B|||
1872|015|U|USES:  This medication is used to treat constipation caused by||
1872|016|U|opioid medication. It blocks the effect of opioids on the gut||
1872|017|U|without blocking the effect on pain. Naldemedine belongs to a||
1872|018|U|class of medications known as opioid antagonists.||
1872|019|B|||
1872|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1872|021|H|pharmacist before you start taking naldemedine and each time you||
1872|022|H|get a refill. If you have any questions, ask your doctor or||
1872|023|H|pharmacist.||
1872|024|H|   Take this medication by mouth with or without food as directed||
1872|025|H|by your doctor, usually once daily.||
1872|026|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1872|027|H|using this medication unless your doctor or pharmacist says you||
1872|028|H|may do so safely. Grapefruit can increase the chance of side||
1872|029|H|effects with this medicine. Ask your doctor or pharmacist for||
1872|030|H|more details.||
1872|031|H|   Ask your doctor if you should keep using your usual||
1872|032|H|medications for constipation. This medication is used only for||
1872|033|H|constipation caused by opioids. Stop taking naldemedine when you||
1872|034|H|stop using opioid pain medication unless otherwise directed by||
1872|035|H|your doctor.||
1872|036|H|   Tell your doctor if your condition lasts or gets worse.||
1872|037|B|||
1872|038|S|SIDE EFFECTS:  Stomach/abdominal pain may occur. If this effect||
1872|039|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
1872|040|S|   Remember that this medication has been prescribed because your||
1872|041|S|doctor has judged that the benefit to you is greater than the||
1872|042|S|risk of side effects. Many people using this medication do not||
1872|043|S|have serious side effects.||
1872|044|S|   Stop taking naldemedine and tell your doctor right away if you||
1872|045|S|have diarrhea that doesn't stop.||
1872|046|S|   Opioid withdrawal symptoms may occur in some people. Tell your||
1872|047|S|doctor right away if any of these withdrawal symptoms occur:||
1872|048|S|sweating, chills, abdominal cramps, diarrhea, mental/mood changes||
1872|049|S|(such as anxiety, confusion, extreme sleepiness, visual||
1872|050|S|hallucinations), unusual yawning.||
1872|051|S|   This drug may rarely cause a serious tear in the stomach or||
1872|052|S|intestinal wall (perforation). Stop taking this medication and||
1872|053|S|get medical help right away if any of these very serious side||
1872|054|S|effects occur: severe stomach/abdominal pain that doesn't go||
1872|055|S|away, fever, severe dizziness, fainting, severe nausea/vomiting.||
1872|056|S|   A very serious allergic reaction to this drug is rare.||
1872|057|S|However, get medical help right away if you notice any symptoms||
1872|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1872|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1872|060|S|breathing.||
1872|061|S|   This is not a complete list of possible side effects. If you||
1872|062|S|notice other effects not listed above, contact your doctor or||
1872|063|S|pharmacist.||
1872|064|S|   In the US -||
1872|065|S|   Call your doctor for medical advice about side effects. You||
1872|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1872|067|S|www.fda.gov/medwatch.||
1872|068|S|   In Canada - Call your doctor for medical advice about side||
1872|069|S|effects. You may report side effects to Health Canada at||
1872|070|S|1-866-234-2345.||
1872|071|B|||
1872|072|P|PRECAUTIONS:  Before taking naldemedine, tell your doctor or||
1872|073|P|pharmacist if you are allergic to it; or if you have any other||
1872|074|P|allergies. This product may contain inactive ingredients, which||
1872|075|P|can cause allergic reactions or other problems. Talk to your||
1872|076|P|pharmacist for more details.||
1872|077|P|   Before using this medication, tell your doctor or pharmacist||
1872|078|P|your medical history, especially of: stomach/intestinal problems||
1872|079|P|(such as blockage, ulcers, tumors, Crohn's disease,||
1872|080|P|diverticulitis), liver disease, chemotherapy/radiation treatment.||
1872|081|P|   Before having surgery, tell your doctor or dentist about all||
1872|082|P|the products you use (including prescription drugs,||
1872|083|P|nonprescription drugs, and herbal products).||
1872|084|P|   During pregnancy, this medication should be used only when||
1872|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
1872|086|P|   It is unknown if this medication passes into breast milk.||
1872|087|P|Consult your doctor before breastfeeding.||
1872|088|B|||
1872|089|I|DRUG INTERACTIONS:  See also How to Use section.||
1872|090|I|   Drug interactions may change how your medications work or||
1872|091|I|increase your risk for serious side effects. This document does||
1872|092|I|not contain all possible drug interactions. Keep a list of all||
1872|093|I|the products you use (including prescription/nonprescription||
1872|094|I|drugs and herbal products) and share it with your doctor and||
1872|095|I|pharmacist. Do not start, stop, or change the dosage of any||
1872|096|I|medicines without your doctor's approval.||
1872|097|I|   Other medications can affect the removal of naldemedine from||
1872|098|I|your body, which may affect how naldemedine works. Examples||
1872|099|I|include enzalutamide, lumacaftor/ivacaftor, mitotane, rifamycins||
1872|100|I|(such as rifampin), St. John's wort, drugs used to treat seizures||
1872|101|I|(such as carbamazepine, phenobarbital, phenytoin, primidone),||
1872|102|I|among others.||
1872|103|B|||
1872|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1872|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1872|106|O|poison control center right away. US residents can call||
1872|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1872|108|B|||
1872|109|N|NOTES:  Do not share this medication with others. Sharing it is||
1872|110|N|against the law.||
1872|111|B|||
1872|112|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1872|113|D|remember. If it is near the time of the next dose, skip the||
1872|114|D|missed dose. Take your next dose at the regular time. Do not||
1872|115|D|double the dose to catch up.||
1872|116|B|||
1872|117|R|STORAGE:  Store at room temperature away from light and moisture.||
1872|118|R|Do not store in the bathroom. Keep all medications away from||
1872|119|R|children and pets.||
1872|120|R|   Do not flush medications down the toilet or pour them into a||
1872|121|R|drain unless instructed to do so. Properly discard this product||
1872|122|R|when it is expired or no longer needed. Consult your pharmacist||
1872|123|R|or local waste disposal company.||
1872|124|B|||
1872|125|A|Information last revised July 2025.||
1872|126|A|Copyright(c) 2025 First Databank, Inc.||
1872|127|B|||
1873|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1873|002|Z|does NOT have all possible information about this product. This||
1873|003|Z|information does not assure that this product is safe, effective,||
1873|004|Z|or appropriate for you. This information is not individual||
1873|005|Z|medical advice and does not substitute for the advice of your||
1873|006|Z|health care professional. Always ask your health care||
1873|007|Z|professional for complete information about this product and your||
1873|008|Z|specific health needs.||
1873|009|B|||
1873|010|T|MEROPENEM/VABORBACTAM - INJECTION||
1873|011|F|(MER-oh-PEN-em/VA-bor-BAK-tam)||
1873|012|B|||
1873|013|C|COMMON BRAND NAME(S): Vabomere||
1873|014|B|||
1873|015|U|USES:  This product is used to treat a variety of bacterial||
1873|016|U|infections. It contains 2 different medications: meropenem and||
1873|017|U|vaborbactam. Meropenem is a carbapenem-type antibiotic that works||
1873|018|U|by stopping the growth of bacteria. Vaborbactam is an enzyme||
1873|019|U|inhibitor (beta-lactamase inhibitor) that helps meropenem work||
1873|020|U|better.||
1873|021|B|||
1873|022|H|HOW TO USE:  This medication is given by injection into a vein as||
1873|023|H|directed by your doctor, usually every 8 hours.||
1873|024|H|   If you are using this medication at home, learn all||
1873|025|H|preparation and usage instructions from your health care||
1873|026|H|professional. Before using, check this product for particles or||
1873|027|H|discoloration. If either is present, do not use the liquid. Learn||
1873|028|H|how to store and discard medical supplies safely.||
1873|029|H|   The dosage is based on your medical condition and response to||
1873|030|H|treatment.||
1873|031|H|   For the best effect, use this antibiotic at evenly spaced||
1873|032|H|times. To help you remember, use this medication at the same||
1873|033|H|times every day.||
1873|034|H|   Continue to use this medication until the full prescribed||
1873|035|H|treatment time is finished, even if symptoms disappear after a||
1873|036|H|few days. Stopping the medication too early may result in a||
1873|037|H|return of the infection.||
1873|038|H|   Tell your doctor if your condition lasts or gets worse.||
1873|039|B|||
1873|040|S|SIDE EFFECTS:  Swelling, redness, pain, or soreness at the||
1873|041|S|injection site may occur. Upset stomach, headache, nausea,||
1873|042|S|vomiting, or diarrhea may also occur. If any of these effects||
1873|043|S|last or get worse, tell your doctor or pharmacist promptly.||
1873|044|S|   Remember that this medication has been prescribed because your||
1873|045|S|doctor has judged that the benefit to you is greater than the||
1873|046|S|risk of side effects. Many people using this medication do not||
1873|047|S|have serious side effects.||
1873|048|S|   Tell your doctor right away if you have any serious side||
1873|049|S|effects, including: easy bruising/bleeding, hearing changes (such||
1873|050|S|as decreased hearing, ringing in the ears), mental/mood changes||
1873|051|S|(such as confusion), numb/tingling skin, swelling ankles/feet,||
1873|052|S|unusual weight gain, unusual tiredness, muscle||
1873|053|S|pain/tenderness/weakness, signs of kidney problems (such as||
1873|054|S|change in the amount of urine).||
1873|055|S|   Get medical help right away if you have any very serious side||
1873|056|S|effects, including: seizures, unusual weakness.||
1873|057|S|   This medication may rarely cause a severe intestinal condition||
1873|058|S|due to a bacteria called C. difficile. This condition may occur||
1873|059|S|during treatment or weeks to months after treatment has stopped.||
1873|060|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1873|061|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1873|062|S|stool.||
1873|063|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1873|064|S|products because they may make symptoms worse.||
1873|065|S|   Use of this medication for prolonged or repeated periods may||
1873|066|S|result in oral thrush or a new yeast infection. Contact your||
1873|067|S|doctor if you notice white patches in your mouth, a change in||
1873|068|S|vaginal discharge, or other new symptoms.||
1873|069|S|   A very serious allergic reaction to this drug is rare.||
1873|070|S|However, get medical help right away if you notice any symptoms||
1873|071|S|of a serious allergic reaction, such as: fever that doesn't go||
1873|072|S|away, new or worsening lymph node swelling, rash,||
1873|073|S|itching/swelling (especially of the face/tongue/throat), severe||
1873|074|S|dizziness, trouble breathing.||
1873|075|S|   This is not a complete list of possible side effects. If you||
1873|076|S|notice other effects not listed above, contact your doctor or||
1873|077|S|pharmacist.||
1873|078|S|   In the US -||
1873|079|S|   Call your doctor for medical advice about side effects. You||
1873|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1873|081|S|www.fda.gov/medwatch.||
1873|082|S|   In Canada - Call your doctor for medical advice about side||
1873|083|S|effects. You may report side effects to Health Canada at||
1873|084|S|1-866-234-2345.||
1873|085|B|||
1873|086|P|PRECAUTIONS:  Before using meropenem/vaborbactam, tell your||
1873|087|P|doctor or pharmacist if you are allergic to it; or to other||
1873|088|P|carbapenems (such as imipenem); or to penicillins or||
1873|089|P|cephalosporins; or if you have any other allergies. This product||
1873|090|P|may contain inactive ingredients, which can cause allergic||
1873|091|P|reactions or other problems. Talk to your pharmacist for more||
1873|092|P|details.||
1873|093|P|   Before using this medication, tell your doctor or pharmacist||
1873|094|P|your medical history, especially of: brain disorders (such as||
1873|095|P|seizures, head injury, tumor), kidney disease, stomach/intestinal||
1873|096|P|diseases (such as colitis).||
1873|097|P|   This drug may rarely cause headaches, numb/tingling skin, or||
1873|098|P|seizures. Do not drive, use machinery, or do anything that needs||
1873|099|P|alertness or clear vision until you can do it safely.||
1873|100|P|   This medication contains sodium. Consult your doctor or||
1873|101|P|pharmacist if you are on a salt-restricted diet or if you have a||
1873|102|P|condition that could be worsened by an increase in salt intake||
1873|103|P|(such as heart failure, high blood pressure).||
1873|104|P|   Meropenem/vaborbactam may cause live bacterial vaccines (such||
1873|105|P|as typhoid vaccine) to not work well. Tell your health care||
1873|106|P|professional that you are using meropenem/vaborbactam before||
1873|107|P|having any immunizations/vaccinations.||
1873|108|P|   Before having surgery, tell your doctor or dentist about all||
1873|109|P|the products you use (including prescription drugs,||
1873|110|P|nonprescription drugs, and herbal products).||
1873|111|P|   Tell your doctor if you are pregnant before using this||
1873|112|P|medication.||
1873|113|P|   Meropenem passes into breast milk. It is unknown if||
1873|114|P|vaborbactam passes into breast milk. Consult your doctor before||
1873|115|P|breastfeeding.||
1873|116|B|||
1873|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1873|118|I|medications work or increase your risk for serious side effects.||
1873|119|I|This document does not contain all possible drug interactions.||
1873|120|I|Keep a list of all the products you use (including||
1873|121|I|prescription/nonprescription drugs and herbal products) and share||
1873|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
1873|123|I|the dosage of any medicines without your doctor's approval.||
1873|124|I|   Some products that may interact with this drug are: valproic||
1873|125|I|acid and related drugs (such as divalproex sodium, sodium||
1873|126|I|valproate).||
1873|127|B|||
1873|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1873|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1873|130|O|poison control center right away. US residents can call||
1873|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1873|132|B|||
1873|133|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1873|134|N|kidney function) may be done while you are using this medication.||
1873|135|N|Keep all medical and lab appointments. Consult your doctor for||
1873|136|N|more details.||
1873|137|B|||
1873|138|D|MISSED DOSE:  It is important to get each dose of this medication||
1873|139|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1873|140|D|right away for a new dosing schedule. Do not double the dose to||
1873|141|D|catch up.||
1873|142|B|||
1873|143|R|STORAGE:  Consult the product instructions and your pharmacist||
1873|144|R|for storage details. Keep all medications away from children and||
1873|145|R|pets.||
1873|146|R|   Do not flush medications down the toilet or pour them into a||
1873|147|R|drain unless instructed to do so. Properly discard this product||
1873|148|R|when it is expired or no longer needed. Consult your pharmacist||
1873|149|R|or local waste disposal company.||
1873|150|B|||
1873|151|A|Information last revised October 2025.||
1873|152|A|Copyright(c) 2025 First Databank, Inc.||
1873|153|B|||
1874|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1874|002|Z|does NOT have all possible information about this product. This||
1874|003|Z|information does not assure that this product is safe, effective,||
1874|004|Z|or appropriate for you. This information is not individual||
1874|005|Z|medical advice and does not substitute for the advice of your||
1874|006|Z|health care professional. Always ask your health care||
1874|007|Z|professional for complete information about this product and your||
1874|008|Z|specific health needs.||
1874|009|B|||
1874|010|T|ABEMACICLIB - ORAL||
1874|011|F|(a-BEM-a-SYE-klib)||
1874|012|B|||
1874|013|C|COMMON BRAND NAME(S): Verzenio||
1874|014|B|||
1874|015|U|USES:  This medication is used to treat certain types of breast||
1874|016|U|cancer. Abemaciclib works by slowing or stopping the growth of||
1874|017|U|cancer cells. It belongs to a class of drugs known as kinase||
1874|018|U|inhibitors.||
1874|019|B|||
1874|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1874|021|H|from your pharmacist before you start using abemaciclib and each||
1874|022|H|time you get a refill. If you have any questions, ask your doctor||
1874|023|H|or pharmacist.||
1874|024|H|   Take this medication by mouth with or without food as directed||
1874|025|H|by your doctor, usually two times daily. Swallow the tablet whole||
1874|026|H|with a glass of water. Do not chew, crush, or split the tablets.||
1874|027|H|Do not take tablets that are broken, cracked, or not whole.||
1874|028|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1874|029|H|using this medication unless your doctor or pharmacist says you||
1874|030|H|may do so safely. Grapefruit can increase the chance of side||
1874|031|H|effects with this medicine. Ask your doctor or pharmacist for||
1874|032|H|more details.||
1874|033|H|   The dosage is based on your medical condition, response to||
1874|034|H|treatment, and other medications you may be taking. Be sure to||
1874|035|H|tell your doctor and pharmacist about all the products you use||
1874|036|H|(including prescription drugs, nonprescription drugs, and herbal||
1874|037|H|products). If you have certain side effects, your doctor may||
1874|038|H|adjust your dose or stop treatment for some time.||
1874|039|H|   Do not increase your dose or use this drug more often or for||
1874|040|H|longer than prescribed. Your condition will not improve any||
1874|041|H|faster, and your risk of serious side effects will increase.||
1874|042|H|   If you vomit your dose of abemaciclib, do not take another||
1874|043|H|dose. Take your next dose at your regular scheduled time. Do not||
1874|044|H|take two doses at the same time.||
1874|045|H|   Take this medication regularly to get the most benefit from||
1874|046|H|it. To help you remember, take it at the same times each day.||
1874|047|H|   Since this drug can be absorbed through the skin and lungs and||
1874|048|H|may harm an unborn baby, women who are pregnant or who may become||
1874|049|H|pregnant should not handle this medication or breathe the dust||
1874|050|H|from the tablets.||
1874|051|B|||
1874|052|S|SIDE EFFECTS:  Nausea, vomiting, upset stomach, loss of appetite,||
1874|053|S|weight loss, constipation, tiredness/weakness, headache, or||
1874|054|S|change in how food tastes may occur. If any of these effects last||
1874|055|S|or get worse, tell your doctor or pharmacist promptly.||
1874|056|S|   Diarrhea is a common side effect that can cause dehydration.||
1874|057|S|Tell your doctor right away if you have loose stools, and ask if||
1874|058|S|you should take anti-diarrheal medication (such as loperamide).||
1874|059|S|Drink plenty of fluids to reduce the risk of dehydration. Contact||
1874|060|S|your doctor promptly if you notice any symptoms of dehydration,||
1874|061|S|such as unusual decreased urination, unusual dry mouth/thirst,||
1874|062|S|fast heartbeat, or dizziness/lightheadedness.||
1874|063|S|   Temporary hair loss may occur. Normal hair growth should||
1874|064|S|return after treatment has ended.||
1874|065|S|   Remember that this medication has been prescribed because your||
1874|066|S|doctor has judged that the benefit to you is greater than the||
1874|067|S|risk of side effects. Many people using this medication do not||
1874|068|S|have serious side effects.||
1874|069|S|   Tell your doctor right away if you have any serious side||
1874|070|S|effects, including: unusual tiredness, easy bruising or bleeding||
1874|071|S|(such as nose/gum bleeds, pink/dark urine), signs of liver damage||
1874|072|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
1874|073|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1874|074|S|   This medication may lower your ability to fight infections.||
1874|075|S|This may make you more likely to get a serious (rarely fatal)||
1874|076|S|infection or make any infection you have worse. Tell your doctor||
1874|077|S|right away if you have any signs of infection (such as sore||
1874|078|S|throat that doesn't go away, fever, chills).||
1874|079|S|   This medication may rarely cause serious problems from blood||
1874|080|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1874|081|S|legs). You may be at increased risk for blood clots if you are||
1874|082|S|severely dehydrated, or have a history of blood clots, or if you||
1874|083|S|are immobile (such as on very long plane flights or being||
1874|084|S|bedridden). If you use estrogen-containing products, these may||
1874|085|S|also increase your risk. Before using this medication, if you||
1874|086|S|have any of these conditions report them to your doctor or||
1874|087|S|pharmacist. Get medical help right away if any of these side||
1874|088|S|effects occur: shortness of breath/rapid breathing,||
1874|089|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1874|090|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1874|091|S|sudden severe headaches, trouble speaking, weakness on one side||
1874|092|S|of the body, sudden vision changes.||
1874|093|S|   A very serious allergic reaction to this drug is rare.||
1874|094|S|However, get medical help right away if you notice any symptoms||
1874|095|S|of a serious allergic reaction, including: rash, itching/swelling||
1874|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1874|097|S|breathing.||
1874|098|S|   This is not a complete list of possible side effects. If you||
1874|099|S|notice other effects not listed above, contact your doctor or||
1874|100|S|pharmacist.||
1874|101|S|   In the US -||
1874|102|S|   Call your doctor for medical advice about side effects. You||
1874|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1874|104|S|www.fda.gov/medwatch.||
1874|105|S|   In Canada - Call your doctor for medical advice about side||
1874|106|S|effects. You may report side effects to Health Canada at||
1874|107|S|1-866-234-2345.||
1874|108|B|||
1874|109|P|PRECAUTIONS:  Before taking abemaciclib, tell your doctor or||
1874|110|P|pharmacist if you are allergic to it; or if you have any other||
1874|111|P|allergies. This product may contain inactive ingredients, which||
1874|112|P|can cause allergic reactions or other problems. Talk to your||
1874|113|P|pharmacist for more details.||
1874|114|P|   Before using this medication, tell your doctor or pharmacist||
1874|115|P|your medical history, especially of: liver disease,||
1874|116|P|bleeding/clotting problems (such as bleeding from||
1874|117|P|intestinal/stomach ulcers).||
1874|118|P|   Abemaciclib can make you more likely to get infections or may||
1874|119|P|make current infections worse. Stay away from anyone who has an||
1874|120|P|infection that may easily spread (such as chickenpox, COVID-19,||
1874|121|P|measles, flu). Talk to your doctor if you have been exposed to an||
1874|122|P|infection or for more details.||
1874|123|P|   Tell your health care professional that you are using||
1874|124|P|abemaciclib before having any immunizations/vaccinations. Avoid||
1874|125|P|contact with people who have recently received live vaccines||
1874|126|P|(such as flu vaccine inhaled through the nose).||
1874|127|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1874|128|P|can make you more dizzy. Do not drive, use machinery, or do||
1874|129|P|anything that needs alertness until you can do it safely. Limit||
1874|130|P|alcoholic beverages. Talk to your doctor if you are using||
1874|131|P|marijuana (cannabis).||
1874|132|P|   Before having surgery, tell your doctor or dentist about all||
1874|133|P|the products you use (including prescription drugs,||
1874|134|P|nonprescription drugs, and herbal products).||
1874|135|P|   Since this drug can be absorbed through the skin and lungs and||
1874|136|P|may harm an unborn baby, women who are pregnant or who may become||
1874|137|P|pregnant should not handle this medication or breathe the dust||
1874|138|P|from the tablets.||
1874|139|P|   Tell your doctor if you are pregnant or plan to become||
1874|140|P|pregnant. You should not become pregnant while using abemaciclib.||
1874|141|P|Abemaciclib may harm an unborn baby. Your doctor should order a||
1874|142|P|pregnancy test before you start this medication. Ask about||
1874|143|P|reliable forms of birth control while using this medication and||
1874|144|P|for at least 3 weeks after the last dose. If you become pregnant,||
1874|145|P|talk to your doctor right away about the risks and benefits of||
1874|146|P|this medication.||
1874|147|P|   It is unknown if this drug passes into breast milk. Because of||
1874|148|P|the possible risk to the infant, breastfeeding is not recommended||
1874|149|P|while using this drug and for at least 3 weeks after the last||
1874|150|P|dose. Consult your doctor before breastfeeding.||
1874|151|B|||
1874|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1874|153|I|medications work or increase your risk for serious side effects.||
1874|154|I|This document does not contain all possible drug interactions.||
1874|155|I|Keep a list of all the products you use (including||
1874|156|I|prescription/nonprescription drugs and herbal products) and share||
1874|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
1874|158|I|the dosage of any medicines without your doctor's approval.||
1874|159|I|   Other medications can affect the removal of abemaciclib from||
1874|160|I|your body, which may affect how abemaciclib works. Examples||
1874|161|I|include azole antifungals (such as ketoconazole, itraconazole,||
1874|162|I|voriconazole), macrolide antibiotics (such as clarithromycin),||
1874|163|I|HIV protease inhibitors (such as atazanavir, nelfinavir),||
1874|164|I|rifamycins (such as rifampin, rifabutin), drugs to treat seizures||
1874|165|I|(such as phenytoin, carbamazepine, phenobarbital), nefazodone,||
1874|166|I|ritonavir, St. John's wort, telithromycin, among others.||
1874|167|I|   This medication can slow down the removal of other medications||
1874|168|I|from your body, which may affect how they work. An example of an||
1874|169|I|affected drug is dofetilide, among others.||
1874|170|B|||
1874|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1874|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1874|173|O|poison control center right away. US residents can call||
1874|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1874|175|O|Symptoms of overdose may include: seizures, extreme dizziness,||
1874|176|O|headache that is extreme or doesn't go away, vomiting blood.||
1874|177|B|||
1874|178|N|NOTES:  Do not share this medication with others.||
1874|179|N|   Lab and/or medical tests (such as liver function, complete||
1874|180|N|blood counts) should be done while you are taking this||
1874|181|N|medication. Keep all medical and lab appointments.||
1874|182|B|||
1874|183|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1874|184|D|next dose at the regular time. Do not double the dose to catch||
1874|185|D|up.||
1874|186|B|||
1874|187|R|STORAGE:  Store at room temperature away from light and moisture.||
1874|188|R|Do not store in the bathroom. Keep all medications away from||
1874|189|R|children and pets.||
1874|190|R|   Do not flush medications down the toilet or pour them into a||
1874|191|R|drain unless instructed to do so. Properly discard this product||
1874|192|R|when it is expired or no longer needed. Consult your pharmacist||
1874|193|R|or local waste disposal company.||
1874|194|B|||
1874|195|M|MEDICAL ALERT:  Your condition can cause complications in a||
1874|196|M|medical emergency. For information about enrolling in MedicAlert,||
1874|197|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1874|198|B|||
1874|199|A|Information last revised April 2025.||
1874|200|A|Copyright(c) 2025 First Databank, Inc.||
1874|201|B|||
1875|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1875|002|Z|does NOT have all possible information about this product. This||
1875|003|Z|information does not assure that this product is safe, effective,||
1875|004|Z|or appropriate for you. This information is not individual||
1875|005|Z|medical advice and does not substitute for the advice of your||
1875|006|Z|health care professional. Always ask your health care||
1875|007|Z|professional for complete information about this product and your||
1875|008|Z|specific health needs.||
1875|009|B|||
1875|010|T|FLUTICASONE BREATH-ACTIVATED SPRAY - NASAL||
1875|011|F|(floo-TIK-a-sone)||
1875|012|B|||
1875|013|C|COMMON BRAND NAME(S): Xhance||
1875|014|B|||
1875|015|U|USES:  Fluticasone is used to treat a certain condition of the||
1875|016|U|nose (chronic rhinosinusitis with or without nasal polyps). It||
1875|017|U|belongs to a class of drugs known as corticosteroids. Fluticasone||
1875|018|U|works by reducing swelling (inflammation) in the nasal passages||
1875|019|U|and sinuses. This can help decrease symptoms such as stuffy nose.||
1875|020|B|||
1875|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
1875|022|H|Instructions for Use if available from your pharmacist before you||
1875|023|H|start using this medication and each time you get a refill. If||
1875|024|H|you have any questions, ask your doctor or pharmacist.||
1875|025|H|   Use this medication in the nose as directed by your doctor,||
1875|026|H|usually twice a day. Do not spray in the eyes or mouth. Gently||
1875|027|H|blow your nose before using this drug. Follow the instructions to||
1875|028|H|properly prime the spray pump if you are using the spray for the||
1875|029|H|first time or if you have not used it for 7 days or more. When||
1875|030|H|priming the pump, make sure to spray away from your face.||
1875|031|H|   To use the spray, remove the protective cap and shake the||
1875|032|H|container well. Tilt your head slightly forward and carefully||
1875|033|H|insert the nasal applicator into a nostril. Insert the mouthpiece||
1875|034|H|into your mouth. Blow hard into the mouthpiece. While blowing||
1875|035|H|into the mouthpiece, press on the bottle to spray the medicine||
1875|036|H|into your nostril. Do not spray directly onto the middle wall of||
1875|037|H|your nose (nasal septum). Do not close your other nostril or||
1875|038|H|breathe in through your nose while the medicine is being sprayed.||
1875|039|H|Repeat in the other nostril.||
1875|040|H|   The dosage is based on your medical condition and response to||
1875|041|H|treatment. Use this medication regularly to get the most benefit||
1875|042|H|from it. To help you remember, use it at the same times each day.||
1875|043|H|Do not increase your dose or use it more often than directed.||
1875|044|H|   Keep track of the number of sprays used from the bottle.||
1875|045|H|Discard the bottle after you have used the number of sprays||
1875|046|H|written on the manufacturer's package.||
1875|047|H|   This medication does not work right away. It may take several||
1875|048|H|days for symptoms to get better and several months or longer||
1875|049|H|before you get the full benefit of this drug.||
1875|050|H|   Tell your doctor if your condition does not get better or if||
1875|051|H|it gets worse.||
1875|052|B|||
1875|053|S|SIDE EFFECTS:  Nosebleeds or nose dryness/irritation may occur.||
1875|054|S|If any of these effects last or get worse, tell your doctor or||
1875|055|S|pharmacist promptly.||
1875|056|S|   Remember that this medication has been prescribed because your||
1875|057|S|doctor has judged that the benefit to you is greater than the||
1875|058|S|risk of side effects. Many people using this medication do not||
1875|059|S|have serious side effects.||
1875|060|S|   Tell your doctor right away if you have any serious side||
1875|061|S|effects, including: pain/sores in your nose, white patches in||
1875|062|S|your nose/mouth, painful swallowing.||
1875|063|S|   Rarely, it is possible that corticosteroids given in the nose||
1875|064|S|will be absorbed into the bloodstream. This can lead to side||
1875|065|S|effects of too much corticosteroid. These side effects are more||
1875|066|S|likely in children and people who use this medication for a long||
1875|067|S|time and in high doses. Tell your doctor right away if any of the||
1875|068|S|following side effects occur: unusual/extreme tiredness, weight||
1875|069|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
1875|070|S|vision problems.||
1875|071|S|   A very serious allergic reaction to this drug is rare.||
1875|072|S|However, get medical help right away if you notice any symptoms||
1875|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1875|074|S|(especially of the face/tongue/throat), severe dizziness,||
1875|075|S|wheezing/trouble breathing.||
1875|076|S|   This is not a complete list of possible side effects. If you||
1875|077|S|notice other effects not listed above, contact your doctor or||
1875|078|S|pharmacist.||
1875|079|S|   In the US -||
1875|080|S|   Call your doctor for medical advice about side effects. You||
1875|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1875|082|S|www.fda.gov/medwatch.||
1875|083|S|   In Canada - Call your doctor for medical advice about side||
1875|084|S|effects. You may report side effects to Health Canada at||
1875|085|S|1-866-234-2345.||
1875|086|B|||
1875|087|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1875|088|P|pharmacist if you are allergic to fluticasone; or if you have any||
1875|089|P|other allergies. This product may contain inactive ingredients,||
1875|090|P|which can cause allergic reactions or other problems. Talk to||
1875|091|P|your pharmacist for more details.||
1875|092|P|   Before using this medication, tell your doctor or pharmacist||
1875|093|P|your medical history, especially of: eye problems (such as||
1875|094|P|glaucoma, cataracts), infections (including tuberculosis, herpes||
1875|095|P|eye infection), recent nose problems (such as injury, ulcers,||
1875|096|P|surgery), liver disease.||
1875|097|P|   Stay away from anyone who has an infection that may easily||
1875|098|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1875|099|P|doctor if you have been exposed to an infection or for more||
1875|100|P|details.||
1875|101|P|   Rarely, using corticosteroid medications for a long time can||
1875|102|P|make it more difficult for your body to respond to physical||
1875|103|P|stress. Before having surgery or emergency treatment, or if you||
1875|104|P|get a serious illness/injury, tell your doctor or dentist that||
1875|105|P|you are using this medication or have used this medication within||
1875|106|P|the past few months.||
1875|107|P|   Before having surgery, tell your doctor or dentist about all||
1875|108|P|the products you use (including prescription drugs,||
1875|109|P|nonprescription drugs, and herbal products).||
1875|110|P|   Though it is unlikely, this medication may temporarily slow||
1875|111|P|down a child's growth if used for a long time. See the doctor||
1875|112|P|regularly so your child's height can be checked.||
1875|113|P|   During pregnancy, this medication should be used only when||
1875|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
1875|115|P|   It is unknown if this medication passes into breast milk.||
1875|116|P|Consult your doctor before breastfeeding.||
1875|117|B|||
1875|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1875|119|I|medications work or increase your risk for serious side effects.||
1875|120|I|This document does not contain all possible drug interactions.||
1875|121|I|Keep a list of all the products you use (including||
1875|122|I|prescription/nonprescription drugs and herbal products) and share||
1875|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
1875|124|I|the dosage of any medicines without your doctor's approval.||
1875|125|I|   Other medications can affect the removal of fluticasone from||
1875|126|I|your body, which may affect how fluticasone works. Examples||
1875|127|I|include HIV protease inhibitors (such as lopinavir), ritonavir,||
1875|128|I|among others.||
1875|129|B|||
1875|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1875|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1875|132|O|poison control center right away. US residents can call||
1875|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1875|134|B|||
1875|135|N|NOTES:  Do not share this medication with others.||
1875|136|N|   If you use this medication for a long time, lab and/or medical||
1875|137|N|tests (such as nose exams, height measurement in children) may be||
1875|138|N|done while you are using this medication. Keep all medical and||
1875|139|N|lab appointments. Consult your doctor for more details.||
1875|140|B|||
1875|141|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1875|142|D|If it is near the time of the next dose, skip the missed dose.||
1875|143|D|Use your next dose at the regular time. Do not double the dose to||
1875|144|D|catch up.||
1875|145|B|||
1875|146|R|STORAGE:  Store at room temperature away from light. Keep all||
1875|147|R|medications away from children and pets.||
1875|148|R|   Do not flush medications down the toilet or pour them into a||
1875|149|R|drain unless instructed to do so. Properly discard this product||
1875|150|R|when it is expired or no longer needed. Consult your pharmacist||
1875|151|R|or local waste disposal company.||
1875|152|B|||
1875|153|A|Information last revised May 2024.||
1875|154|A|Copyright(c) 2025 First Databank, Inc.||
1875|155|B|||
1876|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1876|002|Z|does NOT have all possible information about this product. This||
1876|003|Z|information does not assure that this product is safe, effective,||
1876|004|Z|or appropriate for you. This information is not individual||
1876|005|Z|medical advice and does not substitute for the advice of your||
1876|006|Z|health care professional. Always ask your health care||
1876|007|Z|professional for complete information about this product and your||
1876|008|Z|specific health needs.||
1876|009|B|||
1876|010|T|TRIAMCINOLONE EXTENDED-RELEASE - INJECTION||
1876|011|F|(TRYE-am-SIN-oh-lone)||
1876|012|B|||
1876|013|C|COMMON BRAND NAME(S): Zilretta||
1876|014|B|||
1876|015|U|USES:  This medication is used to treat knee pain in people with||
1876|016|U|a certain type of arthritis (osteoarthritis). It works by||
1876|017|U|reducing your body's immune response. Triamcinolone belongs to a||
1876|018|U|class of drugs known as corticosteroids. It helps to reduce pain||
1876|019|U|and swelling in the knee.||
1876|020|B|||
1876|021|H|HOW TO USE:  This medication is given by injection as a single||
1876|022|H|dose into the affected knee by a health care professional.||
1876|023|H|   Ask your doctor what activities are safe for your knee after||
1876|024|H|the injection.||
1876|025|H|   Tell your doctor if your condition lasts or gets worse.||
1876|026|B|||
1876|027|S|SIDE EFFECTS:  Pain at the injection site may occur. If this||
1876|028|S|effect lasts or gets worse, tell your doctor or pharmacist||
1876|029|S|promptly.||
1876|030|S|   Remember that this medication has been prescribed because your||
1876|031|S|doctor has judged that the benefit to you is greater than the||
1876|032|S|risk of side effects. Many people using this medication do not||
1876|033|S|have serious side effects.||
1876|034|S|   This medication may raise your blood pressure. Check your||
1876|035|S|blood pressure regularly and tell your doctor if the results are||
1876|036|S|high.||
1876|037|S|   This medication may make your blood sugar rise, which can||
1876|038|S|cause or worsen diabetes. Tell your doctor right away if you have||
1876|039|S|symptoms of high blood sugar such as increased thirst/urination.||
1876|040|S|If you already have diabetes, check your blood sugar regularly as||
1876|041|S|directed and share the results with your doctor. Your doctor may||
1876|042|S|need to adjust your diabetes medication, exercise program, or||
1876|043|S|diet.||
1876|044|S|   This medication may lower your ability to fight infections.||
1876|045|S|This may make you more likely to get a serious (rarely fatal)||
1876|046|S|infection or make any infection you have worse. Tell your doctor||
1876|047|S|right away if you have any signs of infection in the affected||
1876|048|S|knee (such as fever, increased pain with swelling of the knee,||
1876|049|S|weakness in the knee, or not being able to bend the knee as much)||
1876|050|S|or other signs of infection (such as sore throat that doesn't go||
1876|051|S|away, chills).||
1876|052|S|   Tell your doctor right away if you have any serious side||
1876|053|S|effects, including: weakness, puffy face, unusual weight gain,||
1876|054|S|thinning skin, bone pain, menstrual period changes, mental/mood||
1876|055|S|changes (such as depression, mood swings, agitation), easy||
1876|056|S|bruising/bleeding, vision problems, swelling ankles/feet/hands,||
1876|057|S|fast/slow/irregular heartbeat, red/purple spots on the skin.||
1876|058|S|   Get medical help right away if you have any very serious side||
1876|059|S|effects, including: symptoms of stomach/intestinal bleeding (such||
1876|060|S|as stomach/abdominal pain, black/tarry stools, vomit that looks||
1876|061|S|like coffee grounds).||
1876|062|S|   A very serious allergic reaction to this drug is rare.||
1876|063|S|However, get medical help right away if you notice any symptoms||
1876|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1876|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1876|066|S|breathing.||
1876|067|S|   This is not a complete list of possible side effects. If you||
1876|068|S|notice other effects not listed above, contact your doctor or||
1876|069|S|pharmacist.||
1876|070|S|   In the US -||
1876|071|S|   Call your doctor for medical advice about side effects. You||
1876|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1876|073|S|www.fda.gov/medwatch.||
1876|074|S|   In Canada - Call your doctor for medical advice about side||
1876|075|S|effects. You may report side effects to Health Canada at||
1876|076|S|1-866-234-2345.||
1876|077|B|||
1876|078|P|PRECAUTIONS:  Before using triamcinolone, tell your doctor or||
1876|079|P|pharmacist if you are allergic to it; or to other corticosteroids||
1876|080|P|(such as methylprednisolone); or if you have any other allergies.||
1876|081|P|This product may contain inactive ingredients, which can cause||
1876|082|P|allergic reactions or other problems. Talk to your pharmacist for||
1876|083|P|more details.||
1876|084|P|   Before using this medication, tell your doctor or pharmacist||
1876|085|P|your medical history, especially of: bleeding problems, blood||
1876|086|P|clots, bone loss (osteoporosis), diabetes, certain eye diseases||
1876|087|P|(such as cataracts, glaucoma, herpes infection of the eye), heart||
1876|088|P|problems (such as heart failure, recent heart attack), high blood||
1876|089|P|pressure, current/past infections (such as joint infections and||
1876|090|P|infections caused by fungus, herpes, tuberculosis, threadworm),||
1876|091|P|kidney disease, liver disease (such as hepatitis B), mental/mood||
1876|092|P|conditions (such as psychosis, anxiety, depression),||
1876|093|P|stomach/intestinal problems (such as diverticulitis, ulcer,||
1876|094|P|ulcerative colitis), seizures, thyroid problems, mineral||
1876|095|P|imbalance, a certain adrenal gland tumor (pheochromocytoma).||
1876|096|P|   Using corticosteroid medications for a long time can make it||
1876|097|P|more difficult for your body to respond to physical stress.||
1876|098|P|Before having surgery or emergency treatment, or if you get a||
1876|099|P|serious illness/injury, tell your doctor or dentist that you are||
1876|100|P|using this medication or have used this medication within the||
1876|101|P|past 12 months. Tell your doctor right away if you develop||
1876|102|P|unusual/extreme tiredness or weight loss. If you will be using||
1876|103|P|this medication for a long time, carry a warning card or medical||
1876|104|P|ID bracelet that identifies your use of this medication.||
1876|105|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
1876|106|P|while using this medicine may increase your risk for stomach||
1876|107|P|bleeding. Limit alcoholic beverages.||
1876|108|P|   This medication may mask signs of infection. It can make you||
1876|109|P|more likely to get infections or may make current infections||
1876|110|P|worse. Stay away from anyone who has an infection that may easily||
1876|111|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1876|112|P|doctor if you have been exposed to an infection or for more||
1876|113|P|details.||
1876|114|P|   Tell your health care professional that you are using||
1876|115|P|triamcinolone before having any immunizations, vaccinations, or||
1876|116|P|skin tests. Avoid contact with people who have recently received||
1876|117|P|live vaccines (such as flu vaccine inhaled through the nose).||
1876|118|P|   Older adults may be more sensitive to the side effects of this||
1876|119|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
1876|120|P|mental/mood changes (such as confusion).||
1876|121|P|   This medication may slow down a child's growth if used for a||
1876|122|P|long time. Consult the doctor or pharmacist for more details. See||
1876|123|P|the doctor regularly so your child's height and growth can be||
1876|124|P|checked.||
1876|125|P|   During pregnancy, this medication should be used only when||
1876|126|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
1876|127|P|risks and benefits with your doctor. Infants born to mothers who||
1876|128|P|use corticosteroid medications for a long time may have hormone||
1876|129|P|problems. Tell your doctor right away if you notice symptoms such||
1876|130|P|as nausea/vomiting that doesn't stop, severe diarrhea, or||
1876|131|P|weakness in your newborn.||
1876|132|P|   It is unknown if this medication passes into breast milk.||
1876|133|P|Consult your doctor before breastfeeding.||
1876|134|B|||
1876|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1876|136|I|medications work or increase your risk for serious side effects.||
1876|137|I|This document does not contain all possible drug interactions.||
1876|138|I|Keep a list of all the products you use (including||
1876|139|I|prescription/nonprescription drugs and herbal products) and share||
1876|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
1876|141|I|the dosage of any medicines without your doctor's approval.||
1876|142|I|   Some products that may interact with this drug are:||
1876|143|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
1876|144|I|cause bleeding/bruising (including antiplatelet drugs such as||
1876|145|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
1876|146|I|such as warfarin/dabigatran).||
1876|147|I|   Aspirin can increase the risk of bleeding when used with this||
1876|148|I|medication. However, if your doctor has told you to take low-dose||
1876|149|I|aspirin to prevent heart attack or stroke (usually 81-162||
1876|150|I|milligrams a day), you should keep taking the aspirin unless your||
1876|151|I|doctor tells you not to. Ask your doctor or pharmacist for more||
1876|152|I|details.||
1876|153|I|   This medication may interfere with certain lab tests (such as||
1876|154|I|skin tests), possibly causing false test results. Make sure lab||
1876|155|I|personnel and all your doctors know you use this drug.||
1876|156|B|||
1876|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1876|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1876|159|O|poison control center right away. US residents can call||
1876|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1876|161|B|||
1876|162|N|NOTES:  Do not share this medication with others.||
1876|163|N|   This medication may cause bone loss (osteoporosis) when used||
1876|164|N|for a long time. Lifestyle changes that may help reduce the risk||
1876|165|N|of bone problems include doing weight-bearing exercise, stopping||
1876|166|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
1876|167|N|D. Talk to your doctor for more details.||
1876|168|B|||
1876|169|D|MISSED DOSE:  Not applicable.||
1876|170|B|||
1876|171|R|STORAGE:  Not applicable. This medication is given in a doctor's||
1876|172|R|office and will not be stored at home.||
1876|173|B|||
1876|174|A|Information last revised September 2025.||
1876|175|A|Copyright(c) 2025 First Databank, Inc.||
1876|176|B|||
1877|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1877|002|Z|does NOT have all possible information about this product. This||
1877|003|Z|information does not assure that this product is safe, effective,||
1877|004|Z|or appropriate for you. This information is not individual||
1877|005|Z|medical advice and does not substitute for the advice of your||
1877|006|Z|health care professional. Always ask your health care||
1877|007|Z|professional for complete information about this product and your||
1877|008|Z|specific health needs.||
1877|009|B|||
1877|010|T|BECLOMETHASONE BREATH-ACTIVATED HFA INHALER - ORAL INHALATION||
1877|011|F|(BE-kloe-METH-a-sone)||
1877|012|B|||
1877|013|C|COMMON BRAND NAME(S): Qvar Redihaler||
1877|014|B|||
1877|015|U|USES:  Beclomethasone is used to prevent and control symptoms||
1877|016|U|(wheezing and shortness of breath) caused by asthma. This||
1877|017|U|medication belongs to a class of drugs known as corticosteroids.||
1877|018|U|It works by reducing the swelling of the airways in the lungs to||
1877|019|U|make breathing easier.||
1877|020|U|   This medication must be used regularly to prevent breathing||
1877|021|U|problems (attacks of wheezing/shortness of breath). It does not||
1877|022|U|work right away and should not be used to relieve an asthma||
1877|023|U|attack. If an attack occurs, use your quick-relief inhaler as||
1877|024|U|prescribed.||
1877|025|B|||
1877|026|V|OTHER USES:  This section contains uses of this drug that are not||
1877|027|V|listed in the approved professional labeling for the drug but||
1877|028|V|that may be prescribed by your health care professional. Use this||
1877|029|V|drug for a condition that is listed in this section only if it||
1877|030|V|has been so prescribed by your health care professional.||
1877|031|V|   This drug may also be used for lung diseases such as||
1877|032|V|bronchitis and emphysema.||
1877|033|B|||
1877|034|H|HOW TO USE:  Read the Patient Information Leaflet and||
1877|035|H|Instructions for Use provided by your pharmacist before you start||
1877|036|H|using this medication and each time you get a refill. If you have||
1877|037|H|any questions, ask your doctor, pharmacist, or respiratory||
1877|038|H|therapist.||
1877|039|H|   Inhale this medication by mouth as directed by your doctor,||
1877|040|H|usually 2 times a day. The dosage is based on your medical||
1877|041|H|condition and response to treatment.||
1877|042|H|   Do not use a spacer device with this medication. You do not||
1877|043|H|need to prime or shake this inhaler before use. If your||
1877|044|H|prescribed dose is 2 puffs, wait at least one minute between||
1877|045|H|them. If you are using other inhalers at the same time, wait at||
1877|046|H|least 1 minute between the use of each medication, and use this||
1877|047|H|drug (the corticosteroid) last.||
1877|048|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
1877|049|H|from developing, gargle, rinse your mouth with water and spit out||
1877|050|H|after each use. Do not swallow the rinse water.||
1877|051|H|   Keep track of the number of inhalations used. Discard the||
1877|052|H|canister after using the labeled number of inhalations on the||
1877|053|H|package, even if it feels as though there is medication left in||
1877|054|H|the canister. Follow the instructions for cleaning the inhaler.||
1877|055|H|Do not wash the inhaler or put any part of it in water.||
1877|056|H|   Use this medication regularly to get the most benefit from it.||
1877|057|H|To help you remember, use it at the same times each day. This||
1877|058|H|medication works best if used at evenly spaced times. Do not||
1877|059|H|increase your dose or use this drug more often or for longer than||
1877|060|H|prescribed. Your condition will not improve any faster, and your||
1877|061|H|risk of side effects will increase.||
1877|062|H|   Do not stop using this medication without consulting your||
1877|063|H|doctor. Some conditions may become worse when the drug is||
1877|064|H|suddenly stopped. Your dose may need to be gradually decreased.||
1877|065|H|   Learn which of your inhalers you should use every day||
1877|066|H|(controller drugs) and which you should use if your breathing||
1877|067|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
1877|068|H|time what you should do if you have new or worsening cough or||
1877|069|H|shortness of breath, wheezing, increased sputum, worsening peak||
1877|070|H|flow meter readings, waking up at night with trouble breathing,||
1877|071|H|if you use your quick-relief inhaler more often (more than 2 days||
1877|072|H|a week), or if your quick-relief inhaler does not seem to be||
1877|073|H|working well. Learn when you can treat sudden breathing problems||
1877|074|H|by yourself and when you must get medical help right away.||
1877|075|H|   If you are regularly taking a different corticosteroid by||
1877|076|H|mouth (such as prednisone), you should not stop taking it unless||
1877|077|H|directed by your doctor. Some conditions (such as asthma,||
1877|078|H|allergies) may become worse when the drug is suddenly stopped. If||
1877|079|H|you suddenly stop taking the drug, you may also have withdrawal||
1877|080|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
1877|081|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
1877|082|H|doctor may slowly lower the dose of your old medication after you||
1877|083|H|begin using beclomethasone. Tell your doctor or pharmacist right||
1877|084|H|away if you have withdrawal. See also Precautions section.||
1877|085|H|   You may start to feel this medication working within 24 hours,||
1877|086|H|but it may take several weeks or longer to get the full benefit.||
1877|087|H|Tell your doctor if you do not get better or if you get worse.||
1877|088|B|||
1877|089|S|SIDE EFFECTS:  See also Precautions section.||
1877|090|S|   Dry/irritated throat, hoarseness, or coughing may occur as||
1877|091|S|your body adjusts to the medication. A bad taste in the mouth or||
1877|092|S|voice changes may also occur. If any of these effects last or get||
1877|093|S|worse, tell your doctor or pharmacist promptly.||
1877|094|S|   Remember that this medication has been prescribed because your||
1877|095|S|doctor has judged that the benefit to you is greater than the||
1877|096|S|risk of side effects. Many people using this medication do not||
1877|097|S|have serious side effects.||
1877|098|S|   Tell your doctor right away if you have any serious side||
1877|099|S|effects, including: white patches in your mouth or on your||
1877|100|S|tongue, puffy face, unusual hair growth, slow wound healing, bone||
1877|101|S|pain, mental/mood changes (such as depression, mood swings,||
1877|102|S|agitation), easy bruising/bleeding, increased thirst/urination,||
1877|103|S|vision problems, signs of infection (such as sore throat that||
1877|104|S|doesn't go away, fever, chills).||
1877|105|S|   Rarely, this medication may cause sudden severe||
1877|106|S|wheezing/trouble breathing right after you use it. If this||
1877|107|S|occurs, use your quick-relief inhaler and get medical help right||
1877|108|S|away.||
1877|109|S|   A very serious allergic reaction to this drug is rare.||
1877|110|S|However, get medical help right away if you notice any symptoms||
1877|111|S|of a serious allergic reaction, including: rash, itching/swelling||
1877|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1877|113|S|breathing.||
1877|114|S|   This is not a complete list of possible side effects. If you||
1877|115|S|notice other effects not listed above, contact your doctor or||
1877|116|S|pharmacist.||
1877|117|S|   In the US -||
1877|118|S|   Call your doctor for medical advice about side effects. You||
1877|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1877|120|S|www.fda.gov/medwatch.||
1877|121|S|   In Canada - Call your doctor for medical advice about side||
1877|122|S|effects. You may report side effects to Health Canada at||
1877|123|S|1-866-234-2345.||
1877|124|B|||
1877|125|P|PRECAUTIONS:  Before using beclomethasone, tell your doctor or||
1877|126|P|pharmacist if you are allergic to it; or if you have any other||
1877|127|P|allergies. This product may contain inactive ingredients, which||
1877|128|P|can cause allergic reactions or other problems. Talk to your||
1877|129|P|pharmacist for more details.||
1877|130|P|   Before using this medication, tell your doctor or pharmacist||
1877|131|P|your medical history, especially of: eye problems (such as||
1877|132|P|cataracts, glaucoma), bone loss (osteoporosis), current/past||
1877|133|P|infections (such as tuberculosis, herpes).||
1877|134|P|   If you have switched from a corticosteroid taken by mouth||
1877|135|P|(such as prednisone tablets) to this inhaler within the past 12||
1877|136|P|months, or if you have been using this product in||
1877|137|P|higher-than-usual doses for a long time, it may be more difficult||
1877|138|P|for your body to respond to physical stress. Before having||
1877|139|P|surgery or emergency treatment, or if you get a serious||
1877|140|P|illness/injury, tell your doctor or dentist that you are using||
1877|141|P|this medication or have used a corticosteroid taken by mouth||
1877|142|P|within the past 12 months. Tell your doctor right away if you||
1877|143|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
1877|144|P|card or medical ID bracelet that says you use (or have used)||
1877|145|P|corticosteroid medications.||
1877|146|P|   This medication may mask signs of infection. It can make you||
1877|147|P|more likely to get infections or may make current infections||
1877|148|P|worse. Stay away from anyone who has an infection that may easily||
1877|149|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
1877|150|P|doctor if you have been exposed to an infection or for more||
1877|151|P|details.||
1877|152|P|   Before having surgery, tell your doctor or dentist about all||
1877|153|P|the products you use (including prescription drugs,||
1877|154|P|nonprescription drugs, and herbal products).||
1877|155|P|   This medication may temporarily slow down a child's growth if||
1877|156|P|used for a long time. However, poorly controlled asthma can also||
1877|157|P|slow down growth. See the doctor regularly so your child's height||
1877|158|P|can be checked.||
1877|159|P|   During pregnancy, this medication should be used only when||
1877|160|P|clearly needed. Discuss the risks and benefits with your doctor.||
1877|161|P|   It is unknown if this medication passes into breast milk.||
1877|162|P|Consult your doctor before breastfeeding.||
1877|163|B|||
1877|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1877|165|I|medications work or increase your risk for serious side effects.||
1877|166|I|This document does not contain all possible drug interactions.||
1877|167|I|Keep a list of all the products you use (including||
1877|168|I|prescription/nonprescription drugs and herbal products) and share||
1877|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
1877|170|I|the dosage of any medicines without your doctor's approval.||
1877|171|I|   Some products that may interact with this drug are:||
1877|172|I|aldesleukin, desmopressin, mifepristone.||
1877|173|I|   This product may interfere with certain lab tests (such as||
1877|174|I|skin tests) possibly causing false test results. Make sure lab||
1877|175|I|personnel and all your doctors know you use this drug.||
1877|176|B|||
1877|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1877|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1877|179|O|poison control center right away. US residents can call||
1877|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1877|181|B|||
1877|182|N|NOTES:  Do not share this medication with others.||
1877|183|N|   Lab and/or medical tests (such as cortisol levels, lung||
1877|184|N|function, eye exams, bone density tests) should be done while you||
1877|185|N|are using this medication. Keep all medical and lab appointments.||
1877|186|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
1877|187|N|mold that can worsen breathing problems. Because the flu virus||
1877|188|N|can also worsen breathing problems, ask your doctor or pharmacist||
1877|189|N|if you should have a flu shot every year.||
1877|190|N|   This medication may cause bone loss (osteoporosis) in adults||
1877|191|N|when used for a long time. Lifestyle changes that may help reduce||
1877|192|N|the risk of bone problems include doing weight-bearing exercise,||
1877|193|N|stopping smoking, limiting alcohol, and getting enough calcium||
1877|194|N|and vitamin D. Talk to your doctor for more details.||
1877|195|B|||
1877|196|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1877|197|D|If it is near the time of the next dose, skip the missed dose.||
1877|198|D|Use your next dose at the regular time. Do not double the dose to||
1877|199|D|catch up.||
1877|200|B|||
1877|201|R|STORAGE:  Store at room temperature away from heat. Do not use or||
1877|202|R|store near high heat or open flame. Because the canisters are||
1877|203|R|under pressure, do not puncture or burn. Keep all medications||
1877|204|R|away from children and pets.||
1877|205|R|   Do not flush medications down the toilet or pour them into a||
1877|206|R|drain unless instructed to do so. Properly discard this product||
1877|207|R|when it is expired or no longer needed. Consult your pharmacist||
1877|208|R|or local waste disposal company.||
1877|209|B|||
1877|210|M|MEDICAL ALERT:  Your condition can cause complications in a||
1877|211|M|medical emergency. For information about enrolling in MedicAlert,||
1877|212|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1877|213|B|||
1877|214|A|Information last revised September 2025.||
1877|215|A|Copyright(c) 2025 First Databank, Inc.||
1877|216|B|||
1878|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1878|002|Z|does NOT have all possible information about this product. This||
1878|003|Z|information does not assure that this product is safe, effective,||
1878|004|Z|or appropriate for you. This information is not individual||
1878|005|Z|medical advice and does not substitute for the advice of your||
1878|006|Z|health care professional. Always ask your health care||
1878|007|Z|professional for complete information about this product and your||
1878|008|Z|specific health needs.||
1878|009|B|||
1878|010|T|MEPOLIZUMAB - INJECTION||
1878|011|F|(ME-poe-LIZ-ue-mab)||
1878|012|B|||
1878|013|C|COMMON BRAND NAME(S): Nucala||
1878|014|B|||
1878|015|U|USES:  This medication is used along with other medications to||
1878|016|U|control and prevent symptoms (such as wheezing and shortness of||
1878|017|U|breath) caused by asthma or ongoing lung disease (chronic||
1878|018|U|obstructive pulmonary disease-COPD). Controlling symptoms of||
1878|019|U|breathing problems helps you do your normal activities and||
1878|020|U|decreases time lost from work or school. Mepolizumab is also used||
1878|021|U|to treat certain other immune system disorders (chronic||
1878|022|U|rhinosinusitis with nasal polyps, eosinophilic granulomatosis||
1878|023|U|with polyangiitis, hypereosinophilic syndrome). This medication||
1878|024|U|works by decreasing a certain type of white blood cell||
1878|025|U|(eosinophils). This effect helps reduce swelling (inflammation)||
1878|026|U|of the airways to make breathing easier. It may also help reduce||
1878|027|U|the size of nasal polyps, and lessen symptoms such as||
1878|028|U|runny/stuffy nose, mucus in the throat, loss of smell, facial||
1878|029|U|pain, and tiredness.||
1878|030|U|   This medication must be used regularly to be effective. It||
1878|031|U|does not work right away and should not be used to relieve sudden||
1878|032|U|asthma attacks or breathing problems. If sudden breathing||
1878|033|U|problems occur, use your quick-relief inhaler as prescribed.||
1878|034|B|||
1878|035|H|HOW TO USE:  Read the Patient Information Leaflet and||
1878|036|H|Instructions for Use if available from your pharmacist before you||
1878|037|H|start using mepolizumab and each time you get a refill. Ask your||
1878|038|H|health care professional how to prepare and use this medication.||
1878|039|H|If you have any questions, ask your doctor or pharmacist.||
1878|040|H|   Inject this medication under the skin as directed by your||
1878|041|H|doctor, usually once every 4 weeks. The injection is given in the||
1878|042|H|upper arm, thigh, or abdomen. The dosage is based on your age,||
1878|043|H|medical condition, and response to treatment.||
1878|044|H|   If you are using the syringe/autoinjector, take it out of the||
1878|045|H|refrigerator at least 30 minutes before you inject it to allow it||
1878|046|H|to reach room temperature. Do not warm up this medication any||
1878|047|H|other way (for example, do not heat it in the microwave or place||
1878|048|H|it in hot water). Do not shake the medication. Before using,||
1878|049|H|check this product for particles or discoloration. If either is||
1878|050|H|present, do not use the liquid. Before injecting each dose, clean||
1878|051|H|the skin you are going to inject into (the injection site) with||
1878|052|H|rubbing alcohol. Change the injection site each time to lessen||
1878|053|H|injury under the skin. Do not inject into skin that is tender,||
1878|054|H|bruised, red, or hard. To lessen bruising, do not rub the||
1878|055|H|injection site after a shot. Learn how to store and discard||
1878|056|H|medical supplies safely.||
1878|057|H|   If you are regularly using a corticosteroid medication, you||
1878|058|H|should not stop using it unless directed by your doctor. Some||
1878|059|H|conditions (such as asthma, allergies) may become worse when the||
1878|060|H|drug is suddenly stopped. If you suddenly stop using the||
1878|061|H|corticosteroid medication, you may also have withdrawal symptoms||
1878|062|H|(such as weakness, weight loss, nausea, muscle pain, headache,||
1878|063|H|tiredness, dizziness). To help prevent withdrawal, your doctor||
1878|064|H|may slowly lower the dose of your corticosteroid medication after||
1878|065|H|you begin using mepolizumab. Tell your doctor or pharmacist right||
1878|066|H|away if you have withdrawal.||
1878|067|H|   Use this medication regularly to get the most benefit from it.||
1878|068|H|To help you remember, mark your calendar with a reminder.||
1878|069|H|   Tell your doctor if your condition does not get better or if||
1878|070|H|it gets worse.||
1878|071|B|||
1878|072|S|SIDE EFFECTS:  Pain/redness/swelling at injection site or||
1878|073|S|headache may occur. If any of these effects last or get worse,||
1878|074|S|tell your doctor or pharmacist promptly.||
1878|075|S|   Remember that this medication has been prescribed because your||
1878|076|S|doctor has judged that the benefit to you is greater than the||
1878|077|S|risk of side effects. Many people using this medication do not||
1878|078|S|have serious side effects.||
1878|079|S|   Tell your doctor right away if you have any serious side||
1878|080|S|effects, including: muscle ache/pain/spasms.||
1878|081|S|   A very serious allergic reaction to this drug is rare.||
1878|082|S|However, get medical help right away if you notice any symptoms||
1878|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1878|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1878|085|S|breathing.||
1878|086|S|   This is not a complete list of possible side effects. If you||
1878|087|S|notice other effects not listed above, contact your doctor or||
1878|088|S|pharmacist.||
1878|089|S|   In the US -||
1878|090|S|   Call your doctor for medical advice about side effects. You||
1878|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1878|092|S|www.fda.gov/medwatch.||
1878|093|S|   In Canada - Call your doctor for medical advice about side||
1878|094|S|effects. You may report side effects to Health Canada at||
1878|095|S|1-866-234-2345.||
1878|096|B|||
1878|097|P|PRECAUTIONS:  Before using mepolizumab, tell your doctor or||
1878|098|P|pharmacist if you are allergic to it; or if you have any other||
1878|099|P|allergies. This product may contain inactive ingredients, which||
1878|100|P|can cause allergic reactions or other problems. Talk to your||
1878|101|P|pharmacist for more details.||
1878|102|P|   Before using this medication, tell your doctor or pharmacist||
1878|103|P|your medical history, especially of: infection due to a parasite.||
1878|104|P|   Before having surgery, tell your doctor or dentist about all||
1878|105|P|the products you use (including prescription drugs,||
1878|106|P|nonprescription drugs, and herbal products).||
1878|107|P|   During pregnancy, this medication should be used only when||
1878|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
1878|109|P|   It is unknown if this medication passes into breast milk.||
1878|110|P|Consult your doctor before breastfeeding.||
1878|111|B|||
1878|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1878|113|I|medications work or increase your risk for serious side effects.||
1878|114|I|This document does not contain all possible drug interactions.||
1878|115|I|Keep a list of all the products you use (including||
1878|116|I|prescription/nonprescription drugs and herbal products) and share||
1878|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
1878|118|I|the dosage of any medicines without your doctor's approval.||
1878|119|B|||
1878|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1878|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1878|122|O|poison control center right away. US residents can call||
1878|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1878|124|B|||
1878|125|N|NOTES:  Do not share this medication with others.||
1878|126|N|   Keep all medical and lab appointments.||
1878|127|B|||
1878|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1878|129|D|If it is near the time of the next dose, skip the missed dose.||
1878|130|D|Use your next dose at the regular time. Do not double the dose to||
1878|131|D|catch up.||
1878|132|B|||
1878|133|R|STORAGE:  Store the syringe/autoinjector in the refrigerator. Do||
1878|134|R|not freeze. Keep the medication in the original package to||
1878|135|R|protect from light. The unopened carton may also be stored at||
1878|136|R|room temperature if needed. If the unopened carton is stored at||
1878|137|R|room temperature, discard the medication after 7 days. Once the||
1878|138|R|syringe/autoinjector is removed from the carton, the medication||
1878|139|R|expires after 8 hours. Keep all medications away from children||
1878|140|R|and pets.||
1878|141|R|   Do not flush medications down the toilet or pour them into a||
1878|142|R|drain unless instructed to do so. Properly discard this product||
1878|143|R|when it is expired or no longer needed. Consult your pharmacist||
1878|144|R|or local waste disposal company.||
1878|145|B|||
1878|146|A|Information last revised June 2025.||
1878|147|A|Copyright(c) 2025 First Databank, Inc.||
1878|148|B|||
1879|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1879|002|Z|does NOT have all possible information about this product. This||
1879|003|Z|information does not assure that this product is safe, effective,||
1879|004|Z|or appropriate for you. This information is not individual||
1879|005|Z|medical advice and does not substitute for the advice of your||
1879|006|Z|health care professional. Always ask your health care||
1879|007|Z|professional for complete information about this product and your||
1879|008|Z|specific health needs.||
1879|009|B|||
1879|010|T|AXICABTAGENE CILOLEUCEL - INJECTION||
1879|011|F|(AX-i-KAB-ta-jeen SYE-loe-LOO-sel)||
1879|012|B|||
1879|013|C|COMMON BRAND NAME(S): Yescarta||
1879|014|B|||
1879|015|W|WARNING:  This medication may cause a serious (even fatal)||
1879|016|W|reaction called cytokine release syndrome-CRS. Careful monitoring||
1879|017|W|and prompt treatment may decrease your risk. Before treatment||
1879|018|W|with this medication, tell your doctor your medical history,||
1879|019|W|especially of any current/recent infection. Tell your doctor||
1879|020|W|right away if you have any symptoms of CRS such as high fever,||
1879|021|W|difficulty breathing, chills/shaking chills, severe||
1879|022|W|nausea/vomiting/diarrhea, severe muscle/joint pain, very low||
1879|023|W|blood pressure, dizziness/lightheadedness.||
1879|024|W|   Serious nerve problems can occur after treatment with||
1879|025|W|axicabtagene ciloleucel. Tell your doctor right away if you have||
1879|026|W|trouble speaking and understanding, loss of balance, seizures, or||
1879|027|W|mental/mood changes (such as anxiety, confusion, memory loss).||
1879|028|B|||
1879|029|U|USES:  Axicabtagene ciloleucel is used to treat a certain type of||
1879|030|U|cancer (non-Hodgkin lymphoma). This type of treatment is known as||
1879|031|U|gene therapy. Axicabtagene ciloleucel is made from your own white||
1879|032|U|blood cells and is given only to you. The white blood cells have||
1879|033|U|been changed to have a specific protein (chimeric antigen||
1879|034|U|receptor-CAR) that helps your body slow or stop the growth of||
1879|035|U|certain cancer cells.||
1879|036|B|||
1879|037|H|HOW TO USE:  Read the Medication Guide provided by your||
1879|038|H|healthcare professional before you start using this product. If||
1879|039|H|you have any questions, ask your healthcare professionals.||
1879|040|H|   Your doctor may give you 3 days of chemotherapy before||
1879|041|H|treatment with this product to prepare your body.||
1879|042|H|   This product is given by slow injection into a vein as||
1879|043|H|directed by your doctor, usually over less than 30 minutes. To||
1879|044|H|decrease the risk of side effects, your doctor may also give you||
1879|045|H|other medications (such as acetaminophen, diphenhydramine) before||
1879|046|H|injecting axicabtagene ciloleucel. The dosage is based on your||
1879|047|H|medical condition and weight. You should plan to stay for at||
1879|048|H|least 2 weeks near the place of your treatment (for example,||
1879|049|H|within 2 hours' drive). Your doctor will check to see if your||
1879|050|H|treatment is working and help you manage any side effects.||
1879|051|B|||
1879|052|S|SIDE EFFECTS:  See also Warning section.||
1879|053|S|   Headache, tiredness, or loss of appetite may occur. If any of||
1879|054|S|these effects last or get worse, tell your doctor or pharmacist||
1879|055|S|promptly.||
1879|056|S|   People using this medication may have serious side effects.||
1879|057|S|However, you have been prescribed this drug because your doctor||
1879|058|S|has judged that the benefit to you is greater than the risk of||
1879|059|S|side effects. Careful monitoring by your doctor may decrease your||
1879|060|S|risk.||
1879|061|S|   Although axicabtagene ciloleucel is used to treat cancer, it||
1879|062|S|may rarely increase your risk of developing other cancers. Also,||
1879|063|S|this product may cause a severe decrease in your blood cells,||
1879|064|S|which lowers your ability to fight infections and increases the||
1879|065|S|risk of anemia/bleeding problems. You may be more likely to get a||
1879|066|S|serious (rarely fatal) infection and any infection you have may||
1879|067|S|get worse. Tell your doctor right away if you develop unusual||
1879|068|S|growths or lumps, swollen lymph nodes, signs of infection (such||
1879|069|S|as sore throat that doesn't go away, fever, chills), easy or||
1879|070|S|unusual bruising/bleeding, or unusual tiredness.||
1879|071|S|   A very serious allergic reaction to this drug is rare.||
1879|072|S|However, get medical help right away if you notice any symptoms||
1879|073|S|of a serious allergic reaction, including: rash, itching/swelling||
1879|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1879|075|S|breathing.||
1879|076|S|   This is not a complete list of possible side effects. If you||
1879|077|S|notice other effects not listed above, contact your doctor or||
1879|078|S|pharmacist.||
1879|079|S|   In the US -||
1879|080|S|   Call your doctor for medical advice about side effects. You||
1879|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1879|082|S|www.fda.gov/medwatch.||
1879|083|S|   In Canada - Call your doctor for medical advice about side||
1879|084|S|effects. You may report side effects to Health Canada at||
1879|085|S|1-866-234-2345.||
1879|086|B|||
1879|087|P|PRECAUTIONS:  Before receiving axicabtagene ciloleucel, tell your||
1879|088|P|doctor or pharmacist if you have any allergies. This product may||
1879|089|P|contain inactive ingredients, which can cause allergic reactions||
1879|090|P|or other problems. Talk to your pharmacist for more details.||
1879|091|P|   Before using this medication, tell your doctor or pharmacist||
1879|092|P|your medical history, especially of: past/current/recent||
1879|093|P|infection (including hepatitis, HIV).||
1879|094|P|   This product can make you more likely to get infections or may||
1879|095|P|make current infections worse. Stay away from anyone who has an||
1879|096|P|infection that may easily spread (such as chickenpox, COVID-19,||
1879|097|P|measles, flu). Talk to your doctor if you have been exposed to an||
1879|098|P|infection or for more details.||
1879|099|P|   Tell your health care professional that you are using||
1879|100|P|axicabtagene ciloleucel before having any||
1879|101|P|immunizations/vaccinations. Avoid contact with people who have||
1879|102|P|recently received live vaccines (such as flu vaccine inhaled||
1879|103|P|through the nose).||
1879|104|P|   To lower the chance of getting cut, bruised, or injured, use||
1879|105|P|caution with sharp objects like razors and nail cutters, and||
1879|106|P|avoid activities such as contact sports.||
1879|107|P|   This drug may make you dizzy, affect your coordination, or||
1879|108|P|make it harder for you to think clearly. Alcohol or marijuana||
1879|109|P|(cannabis) can worsen these effects. Do not drive, use machinery,||
1879|110|P|or do anything that needs alertness until you can do it safely||
1879|111|P|(at least 2 weeks after receiving treatment is recommended by the||
1879|112|P|manufacturer). Limit alcoholic beverages. Talk to your doctor if||
1879|113|P|you are using marijuana (cannabis).||
1879|114|P|   Before having surgery, tell your doctor or dentist about all||
1879|115|P|the products you use (including prescription drugs,||
1879|116|P|nonprescription drugs, and herbal products).||
1879|117|P|   Tell your doctor if you are pregnant or plan to become||
1879|118|P|pregnant. You should not become pregnant while using axicabtagene||
1879|119|P|ciloleucel. Axicabtagene ciloleucel may harm an unborn baby. Your||
1879|120|P|doctor should order a pregnancy test before you start this||
1879|121|P|medication. If you become pregnant, talk to your doctor right||
1879|122|P|away about the risks and benefits of this medication.||
1879|123|P|   It is unknown if this product passes into breast milk. Consult||
1879|124|P|your doctor before breastfeeding.||
1879|125|B|||
1879|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1879|127|I|medications work or increase your risk for serious side effects.||
1879|128|I|This document does not contain all possible drug interactions.||
1879|129|I|Keep a list of all the products you use (including||
1879|130|I|prescription/nonprescription drugs and herbal products) and share||
1879|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
1879|132|I|the dosage of any medicines without your doctor's approval.||
1879|133|B|||
1879|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1879|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1879|136|O|poison control center right away. US residents can call||
1879|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1879|138|B|||
1879|139|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
1879|140|N|should be done before and after you receive this product. Keep||
1879|141|N|all medical and lab appointments.||
1879|142|N|   After receiving this treatment, do not donate blood, organs,||
1879|143|N|tissues, or cells.||
1879|144|B|||
1879|145|D|MISSED DOSE:  If your dose is interrupted or stopped, ask your||
1879|146|D|doctor or pharmacist right away for a new dosing schedule.||
1879|147|B|||
1879|148|R|STORAGE:  Not applicable. This product is given in a hospital or||
1879|149|R|clinic and will not be stored at home.||
1879|150|B|||
1879|151|M|MEDICAL ALERT:  Your condition can cause complications in a||
1879|152|M|medical emergency. For information about enrolling in MedicAlert,||
1879|153|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1879|154|B|||
1879|155|A|Information last revised June 2025.||
1879|156|A|Copyright(c) 2025 First Databank, Inc.||
1879|157|B|||
1880|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1880|002|Z|does NOT have all possible information about this product. This||
1880|003|Z|information does not assure that this product is safe, effective,||
1880|004|Z|or appropriate for you. This information is not individual||
1880|005|Z|medical advice and does not substitute for the advice of your||
1880|006|Z|health care professional. Always ask your health care||
1880|007|Z|professional for complete information about this product and your||
1880|008|Z|specific health needs.||
1880|009|B|||
1880|010|T|BENZNIDAZOLE - ORAL||
1880|011|F|(benz-NID-a-zole)||
1880|012|B|||
1880|013|U|USES:  Benznidazole is an antibiotic that is used to treat a||
1880|014|U|certain parasitic infection (Chagas disease). It works by||
1880|015|U|stopping the growth of a certain parasite.||
1880|016|U|   This antibiotic treats only Chagas disease. It will not work||
1880|017|U|for viral infections (such as common cold, flu). Using any||
1880|018|U|antibiotic when it is not needed can cause it to not work for||
1880|019|U|future infections.||
1880|020|B|||
1880|021|H|HOW TO USE:  Read the Instructions for Use if available from your||
1880|022|H|pharmacist before you start taking benznidazole and each time you||
1880|023|H|get a refill. If you have any questions, ask your doctor or||
1880|024|H|pharmacist.||
1880|025|H|   Take this medication by mouth with or without food as directed||
1880|026|H|by your doctor, usually twice daily (about 12 hours apart). The||
1880|027|H|dosage is based on your weight.||
1880|028|H|   If you have trouble swallowing the tablet, you can dissolve it||
1880|029|H|in a cup of water for 1 to 2 minutes. Swirl the cup gently to mix||
1880|030|H|and then drink the mixture right away. Rinse the cup with more||
1880|031|H|water and drink the rinse water to make sure you have taken the||
1880|032|H|whole dose. The amount of water needed to dissolve the tablet and||
1880|033|H|also to rinse your cup depends on your dose. Ask your pharmacist||
1880|034|H|or doctor for specific instructions.||
1880|035|H|   For the best effect, take this antibiotic at evenly spaced||
1880|036|H|times. To help you remember, take this medication at the same||
1880|037|H|times every day.||
1880|038|H|   Continue to take this medication until the full prescribed||
1880|039|H|amount is finished, even if symptoms disappear after a few days.||
1880|040|H|Stopping the medication too early may result in a return of the||
1880|041|H|infection.||
1880|042|H|   Tell your doctor if your condition lasts or gets worse.||
1880|043|B|||
1880|044|S|SIDE EFFECTS:  Dizziness, headache, abdominal pain,||
1880|045|S|nausea/vomiting, loss of appetite, or diarrhea may occur. If any||
1880|046|S|of these effects last or get worse, tell your doctor or||
1880|047|S|pharmacist promptly.||
1880|048|S|   Remember that this medication has been prescribed because your||
1880|049|S|doctor has judged that the benefit to you is greater than the||
1880|050|S|risk of side effects. Many people using this medication do not||
1880|051|S|have serious side effects.||
1880|052|S|   Tell your doctor right away if you have any serious side||
1880|053|S|effects, including: numbness/tingling of arms/legs, easy||
1880|054|S|bruising/bleeding, unusual tiredness.||
1880|055|S|   A very serious allergic reaction to this drug is rare.||
1880|056|S|However, get medical help right away if you notice any symptoms||
1880|057|S|of a serious allergic reaction, including: fever that doesn't go||
1880|058|S|away, new or worsening lymph node swelling, rash,||
1880|059|S|itching/swelling (especially of the face/tongue/throat), severe||
1880|060|S|dizziness, trouble breathing.||
1880|061|S|   This is not a complete list of possible side effects. If you||
1880|062|S|notice other effects not listed above, contact your doctor or||
1880|063|S|pharmacist.||
1880|064|S|   In the US -||
1880|065|S|   Call your doctor for medical advice about side effects. You||
1880|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1880|067|S|www.fda.gov/medwatch.||
1880|068|S|   In Canada - Call your doctor for medical advice about side||
1880|069|S|effects. You may report side effects to Health Canada at||
1880|070|S|1-866-234-2345.||
1880|071|B|||
1880|072|P|PRECAUTIONS:  Before taking benznidazole, tell your doctor or||
1880|073|P|pharmacist if you are allergic to it; or to related antibiotics||
1880|074|P|(such as metronidazole, tinidazole); or if you have any other||
1880|075|P|allergies. This product may contain inactive ingredients, which||
1880|076|P|can cause allergic reactions or other problems. Talk to your||
1880|077|P|pharmacist for more details.||
1880|078|P|   Before using this medication, tell your doctor or pharmacist||
1880|079|P|your medical history, especially of: certain blood disorders (low||
1880|080|P|blood cell counts), a certain rare genetic disorder (Cockayne||
1880|081|P|syndrome).||
1880|082|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1880|083|P|can make you more dizzy. Do not drive, use machinery, or do||
1880|084|P|anything that needs alertness until you can do it safely. Limit||
1880|085|P|alcoholic beverages. Talk to your doctor if you are using||
1880|086|P|marijuana (cannabis).||
1880|087|P|   Before having surgery, tell your doctor or dentist about all||
1880|088|P|the products you use (including prescription drugs,||
1880|089|P|nonprescription drugs, and herbal products).||
1880|090|P|   This drug may affect genetic information in cells (genotoxic).||
1880|091|P|Talk to your doctor about the risks and benefits of this||
1880|092|P|medication.||
1880|093|P|   Tell your doctor if you are pregnant or plan to become||
1880|094|P|pregnant. You should not become pregnant while using||
1880|095|P|benznidazole. Benznidazole may harm an unborn baby. Your doctor||
1880|096|P|should order a pregnancy test before you start this medication.||
1880|097|P|Ask about reliable forms of birth control while using this||
1880|098|P|medication and for 5 days after the last dose. If you become||
1880|099|P|pregnant, talk to your doctor right away about the risks and||
1880|100|P|benefits of this medication.||
1880|101|P|   This medication passes into breast milk. Because of the||
1880|102|P|possible risk to the infant, breastfeeding is not recommended||
1880|103|P|while using this medication. Consult your doctor before||
1880|104|P|breastfeeding.||
1880|105|B|||
1880|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1880|107|I|medications work or increase your risk for serious side effects.||
1880|108|I|This document does not contain all possible drug interactions.||
1880|109|I|Keep a list of all the products you use (including||
1880|110|I|prescription/nonprescription drugs and herbal products) and share||
1880|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
1880|112|I|the dosage of any medicines without your doctor's approval.||
1880|113|I|   Do not take benznidazole if you are also taking disulfiram or||
1880|114|I|if you have taken disulfiram within the last 2 weeks.||
1880|115|B|||
1880|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1880|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1880|118|O|poison control center right away. US residents can call||
1880|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1880|120|B|||
1880|121|N|NOTES:  Do not share this medication with others.||
1880|122|N|   This medication has been prescribed for your current condition||
1880|123|N|only. Do not use it later for another infection unless your||
1880|124|N|doctor tells you to.||
1880|125|N|   Lab and/or medical tests (such as complete blood count) may be||
1880|126|N|done while you are taking this medication. Keep all medical and||
1880|127|N|lab appointments. Consult your doctor for more details.||
1880|128|B|||
1880|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1880|130|D|remember. If it is near the time of the next dose, skip the||
1880|131|D|missed dose. Take your next dose at the regular time. Do not||
1880|132|D|double the dose to catch up.||
1880|133|B|||
1880|134|R|STORAGE:  Store at room temperature away from light and moisture.||
1880|135|R|Do not store in the bathroom. Keep all medications away from||
1880|136|R|children and pets.||
1880|137|R|   Do not flush medications down the toilet or pour them into a||
1880|138|R|drain unless instructed to do so. Properly discard this product||
1880|139|R|when it is expired or no longer needed. Consult your pharmacist||
1880|140|R|or local waste disposal company.||
1880|141|B|||
1880|142|A|Information last revised May 2024.||
1880|143|A|Copyright(c) 2025 First Databank, Inc.||
1880|144|B|||
1881|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1881|002|Z|does NOT have all possible information about this product. This||
1881|003|Z|information does not assure that this product is safe, effective,||
1881|004|Z|or appropriate for you. This information is not individual||
1881|005|Z|medical advice and does not substitute for the advice of your||
1881|006|Z|health care professional. Always ask your health care||
1881|007|Z|professional for complete information about this product and your||
1881|008|Z|specific health needs.||
1881|009|B|||
1881|010|T|RELUGOLIX/ESTRADIOL/NORETHINDRONE - ORAL||
1881|011|F|(REL-ue-GOE-lix/ES-tra-DYE-ol/nor-ETH-in-drone)||
1881|012|B|||
1881|013|C|COMMON BRAND NAME(S): Myfembree||
1881|014|B|||
1881|015|W|WARNING:  Combination hormone treatment increases the risk of||
1881|016|W|blood clot problems, including clots in the legs, lungs, and||
1881|017|W|heart. Do not use this medication if you smoke cigarettes/use||
1881|018|W|tobacco and are over 35 years old. Smoking raises your risk of||
1881|019|W|stroke, heart attack, blood clots, and high blood pressure from||
1881|020|W|this product. The risk of these serious problems increases with||
1881|021|W|age and with the number of cigarettes you smoke. Do not smoke or||
1881|022|W|use tobacco.||
1881|023|B|||
1881|024|U|USES:  This medication is a combination of 3 ingredients:||
1881|025|U|relugolix, estradiol, and norethindrone. It is used by women who||
1881|026|U|have not gone through menopause to help manage heavy menstrual||
1881|027|U|bleeding due to uterine fibroids or pain due to endometriosis.||
1881|028|U|Relugolix works by decreasing your body's production of certain||
1881|029|U|hormones (luteinizing hormone, follicle-stimulating hormone),||
1881|030|U|which leads to lower amounts of female sex hormones (estrogens).||
1881|031|U|Estradiol is used to decrease bone loss caused by relugolix,||
1881|032|U|while norethindrone is used to help lessen the risk of cancer of||
1881|033|U|the uterus due to estradiol.||
1881|034|B|||
1881|035|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1881|036|H|from your pharmacist before you start taking this medication and||
1881|037|H|each time you get a refill. If you have any questions, ask your||
1881|038|H|doctor or pharmacist.||
1881|039|H|   To make sure you are not pregnant, your doctor may do a||
1881|040|H|pregnancy test before you start taking this medication, or tell||
1881|041|H|you to start taking it within 7 days after the start of your||
1881|042|H|menstrual period. Start taking this medication only when directed||
1881|043|H|by your doctor.||
1881|044|H|   Take this medication by mouth with or without food as directed||
1881|045|H|by your doctor, usually once daily. Use this medication regularly||
1881|046|H|to get the most benefit from it. To help you remember, take it at||
1881|047|H|the same time each day. To lessen the risk of bone loss||
1881|048|H|(osteoporosis), your doctor may tell you to stop taking this||
1881|049|H|medication after 24 months. Talk with your doctor for details.||
1881|050|H|   Tell your doctor if your condition does not get better or if||
1881|051|H|it gets worse.||
1881|052|B|||
1881|053|S|SIDE EFFECTS:  Hot flashes, increased sweating, night sweats, or||
1881|054|S|menstrual period changes may occur. If any of these effects last||
1881|055|S|or get worse, tell your doctor or pharmacist promptly.||
1881|056|S|   Hair thinning and hair loss may occur. It is unknown if normal||
1881|057|S|hair growth will return after treatment has ended.||
1881|058|S|   Remember that this medication has been prescribed because your||
1881|059|S|doctor has judged that the benefit to you is greater than the||
1881|060|S|risk of side effects. Many people using this medication do not||
1881|061|S|have serious side effects.||
1881|062|S|   This medication may raise your blood pressure. Check your||
1881|063|S|blood pressure regularly and tell your doctor if the results are||
1881|064|S|high.||
1881|065|S|   Tell your doctor right away if you have any serious side||
1881|066|S|effects, including: lumps in the breast, mental/mood changes||
1881|067|S|(such as new or worsening depression, anxiety, unusual changes in||
1881|068|S|behavior, thoughts of suicide), signs of liver damage (such as||
1881|069|S|nausea/vomiting that doesn't stop, loss of appetite,||
1881|070|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), unusual||
1881|071|S|changes in vaginal bleeding (such as continuous spotting, sudden||
1881|072|S|heavy bleeding), symptoms of high blood sugar (such as increased||
1881|073|S|thirst/urination).||
1881|074|S|   The relugolix in this medication lowers estrogen levels in||
1881|075|S|your body. Low estrogen levels can lead to bone loss||
1881|076|S|(osteoporosis). The risk is increased with higher doses or with||
1881|077|S|longer use of this medication. Some bone loss may be permanent.||
1881|078|S|Talk with your doctor about the risks and benefits of taking this||
1881|079|S|medication, and ask about taking calcium supplements and vitamin||
1881|080|S|D for bone health.||
1881|081|S|   This medication may rarely cause serious (sometimes fatal)||
1881|082|S|problems from blood clots (such as heart attack, stroke, blood||
1881|083|S|clots in the lungs or legs). Get medical help right away if you||
1881|084|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1881|085|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
1881|086|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1881|087|S|trouble speaking, weakness on one side of the body, sudden vision||
1881|088|S|changes.||
1881|089|S|   A very serious allergic reaction to this drug is rare.||
1881|090|S|However, get medical help right away if you notice any symptoms||
1881|091|S|of a serious allergic reaction, including: rash, itching/swelling||
1881|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1881|093|S|breathing.||
1881|094|S|   This is not a complete list of possible side effects. If you||
1881|095|S|notice other effects not listed above, contact your doctor or||
1881|096|S|pharmacist.||
1881|097|S|   In the US -||
1881|098|S|   Call your doctor for medical advice about side effects. You||
1881|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1881|100|S|www.fda.gov/medwatch.||
1881|101|S|   In Canada - Call your doctor for medical advice about side||
1881|102|S|effects. You may report side effects to Health Canada at||
1881|103|S|1-866-234-2345.||
1881|104|B|||
1881|105|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1881|106|P|pharmacist if you are allergic to relugolix, estradiol, or||
1881|107|P|norethindrone; or to any estrogens (such as mestranol) or any||
1881|108|P|progestins (such as desogestrel) or if you have any other||
1881|109|P|allergies. This product may contain inactive ingredients, which||
1881|110|P|can cause allergic reactions or other problems. Talk to your||
1881|111|P|pharmacist for more details.||
1881|112|P|   Before using this medication, tell your doctor or pharmacist||
1881|113|P|your medical history, especially of: blood clots (for example, in||
1881|114|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
1881|115|P|C or protein S deficiency), high blood pressure, abnormal breast||
1881|116|P|exam, bone loss (osteoporosis), cancer (especially endometrial or||
1881|117|P|breast cancer), high cholesterol or triglyceride (blood fat)||
1881|118|P|levels, diabetes, family or personal history of a certain||
1881|119|P|swelling disorder (angioedema), gallbladder problems, severe||
1881|120|P|headaches/migraines, heart problems (such as heart valve disease,||
1881|121|P|irregular heartbeat, previous heart attack), history of yellowing||
1881|122|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
1881|123|P|birth control (such as pills, patch), kidney disease, liver||
1881|124|P|disease (including tumors), mental/mood disorders (such as||
1881|125|P|depression), obesity, stroke, swelling (edema), thyroid problems,||
1881|126|P|unexplained vaginal bleeding.||
1881|127|P|   This medication may cause blotchy, dark areas on your skin||
1881|128|P|(melasma). Sunlight may worsen this effect. Avoid prolonged sun||
1881|129|P|exposure, sunlamps, and tanning booths. Use a sunscreen, and wear||
1881|130|P|protective clothing when outdoors.||
1881|131|P|   Tell your doctor if you just had or will be having surgery or||
1881|132|P|if you will be confined to a bed or chair for a long time (such||
1881|133|P|as a long plane flight). These conditions increase your risk of||
1881|134|P|getting blood clots, especially if you are using hormone||
1881|135|P|replacement. You may need to stop this medication for a time||
1881|136|P|(such as 4 to 6 weeks before surgery) or take special||
1881|137|P|precautions. If your doctor tells you to stop this medication||
1881|138|P|before surgery, ask for specific directions about when to restart||
1881|139|P|this medication.||
1881|140|P|   This product must not be used during pregnancy. It may harm an||
1881|141|P|unborn baby. Ask about reliable forms of non-hormonal birth||
1881|142|P|control (such as condoms, spermicide) while using this medication||
1881|143|P|and for 1 week after stopping treatment. Because this medication||
1881|144|P|affects menstruation, it may be harder to tell if you are||
1881|145|P|pregnant. If you become pregnant or think you may be pregnant,||
1881|146|P|tell your doctor right away.||
1881|147|P|   This product passes into breast milk. Consult your doctor||
1881|148|P|before breastfeeding.||
1881|149|B|||
1881|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1881|151|I|medications work or increase your risk for serious side effects.||
1881|152|I|This document does not contain all possible drug interactions.||
1881|153|I|Keep a list of all the products you use (including||
1881|154|I|prescription/nonprescription drugs and herbal products) and share||
1881|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
1881|156|I|the dosage of any medicines without your doctor's approval.||
1881|157|I|   Some products that may interact with this drug are: aromatase||
1881|158|I|inhibitors (such as anastrozole, exemestane, letrozole),||
1881|159|I|fezolinetant, ospemifene, tamoxifen, tranexamic acid.||
1881|160|I|   Other medications can affect the removal of this medication||
1881|161|I|from your body, which may affect how it works. Examples include||
1881|162|I|erythromycin, rifampin, St. John's wort, some drugs used to treat||
1881|163|I|seizures (such as carbamazepine, phenytoin), among others.||
1881|164|I|   This medication may interfere with certain lab tests (such as||
1881|165|I|blood tests for clotting factors, thyroid), possibly causing||
1881|166|I|false test results. Make sure lab personnel and all your doctors||
1881|167|I|know you use this medication.||
1881|168|B|||
1881|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1881|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1881|171|O|poison control center right away. US residents can call||
1881|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1881|173|B|||
1881|174|N|NOTES:  Do not share this medication with others.||
1881|175|N|   Lab and/or medical tests (such as liver function, cholesterol,||
1881|176|N|pregnancy test, blood pressure, bone density tests) may be done||
1881|177|N|before you start taking this medication and while you are taking||
1881|178|N|it. Keep all medical and lab appointments.||
1881|179|B|||
1881|180|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1881|181|D|remember. If you don't remember until the next day, skip the||
1881|182|D|missed dose. Take your next dose at the regular time. Do not||
1881|183|D|double the dose to catch up.||
1881|184|B|||
1881|185|R|STORAGE:  Store at room temperature away from light and moisture.||
1881|186|R|Do not store in the bathroom. Keep all medications away from||
1881|187|R|children and pets.||
1881|188|R|   Do not flush medications down the toilet or pour them into a||
1881|189|R|drain unless instructed to do so. Properly discard this product||
1881|190|R|when it is expired or no longer needed. Consult your pharmacist||
1881|191|R|or local waste disposal company.||
1881|192|B|||
1881|193|A|Information last revised September 2025.||
1881|194|A|Copyright(c) 2025 First Databank, Inc.||
1881|195|B|||
1882|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1882|002|Z|does NOT have all possible information about this product. This||
1882|003|Z|information does not assure that this product is safe, effective,||
1882|004|Z|or appropriate for you. This information is not individual||
1882|005|Z|medical advice and does not substitute for the advice of your||
1882|006|Z|health care professional. Always ask your health care||
1882|007|Z|professional for complete information about this product and your||
1882|008|Z|specific health needs.||
1882|009|B|||
1882|010|T|VARICELLA VIRUS VACCINE (SHINGLES) - INJECTION||
1882|011|F|(VAR-i-SEL-a)||
1882|012|B|||
1882|013|C|COMMON BRAND NAME(S): Shingrix||
1882|014|B|||
1882|015|U|USES:  This vaccine is used to help prevent zoster (shingles) in||
1882|016|U|adults. Zoster is caused by the same virus that causes||
1882|017|U|chickenpox. After you have been infected with chickenpox (usually||
1882|018|U|in childhood), the virus can live in your body's nerve roots in||
1882|019|U|an inactive form. Later in life, the virus may become active||
1882|020|U|again and cause shingles. Symptoms of shingles include a painful||
1882|021|U|rash and blisters. Shingles may also rarely cause serious||
1882|022|U|problems such as blindness, hearing problems, and long-term nerve||
1882|023|U|pain. Vaccination is the best way to protect against this||
1882|024|U|infection.||
1882|025|U|   This vaccine works by increasing the body's natural defense||
1882|026|U|(immunity) against the zoster virus so that symptoms of shingles||
1882|027|U|do not occur.||
1882|028|U|   Vaccines may not fully protect everyone who receives them.||
1882|029|B|||
1882|030|H|HOW TO USE:  Read all vaccine information available from your||
1882|031|H|health care professional before receiving the vaccine. If you||
1882|032|H|have any questions, ask your health care professional.||
1882|033|H|   This vaccine is given by injection into a muscle by a health||
1882|034|H|care professional. It is given in the upper arm.||
1882|035|H|   Vaccines are usually given in a series of doses to provide the||
1882|036|H|best protection. Closely follow the vaccination schedule provided||
1882|037|H|by your health care professional. To help you remember, mark your||
1882|038|H|calendar with a reminder.||
1882|039|B|||
1882|040|S|SIDE EFFECTS:  Redness/swelling/bruising/pain at the injection||
1882|041|S|site, headache, muscle pain, tiredness, or fever may occur. If||
1882|042|S|any of these effects last or get worse, tell your health care||
1882|043|S|professional promptly.||
1882|044|S|   Rarely, some people have symptoms such as fainting, dizziness,||
1882|045|S|vision changes, or ringing in the ears just after getting a||
1882|046|S|vaccine injection. Tell your health care professional right away||
1882|047|S|if you have any of these symptoms. Sitting or lying down may||
1882|048|S|help, since these symptoms usually don't last long.||
1882|049|S|   Remember that this vaccine has been prescribed because your||
1882|050|S|health care professional has judged that the benefit to you is||
1882|051|S|greater than the risk of side effects. Many people using this||
1882|052|S|vaccine do not have serious side effects.||
1882|053|S|   Tell your health care professional right away if you have any||
1882|054|S|serious side effects, including: numbness/tingling, muscle||
1882|055|S|weakness.||
1882|056|S|   A very serious allergic reaction to this vaccine is rare.||
1882|057|S|However, get medical help right away if you notice any symptoms||
1882|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1882|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1882|060|S|breathing.||
1882|061|S|   This is not a complete list of possible side effects. If you||
1882|062|S|notice other effects not listed above, contact your health care||
1882|063|S|professional.||
1882|064|S|   Contact the doctor for medical advice about side effects. The||
1882|065|S|following numbers do not provide medical advice, but in the US||
1882|066|S|you may report side effects to the Vaccine Adverse Event||
1882|067|S|Reporting System (VAERS) at 1-800-822-7967. In Canada, you may||
1882|068|S|call the Vaccine Safety Section at Public Health Agency of Canada||
1882|069|S|at 1-866-844-0018.||
1882|070|B|||
1882|071|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
1882|072|P|care professional if you are allergic to it; or if you have any||
1882|073|P|other allergies. This product may contain inactive ingredients,||
1882|074|P|which can cause allergic reactions or other problems. Talk to||
1882|075|P|your health care professional for more details.||
1882|076|P|   Before receiving this vaccine, tell your health care||
1882|077|P|professional your medical history, especially of: current||
1882|078|P|fever/illness, immune system disorders (such as due to HIV||
1882|079|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
1882|080|P|radiation treatment), vaccination history (including previous||
1882|081|P|reactions to any vaccines).||
1882|082|P|   During pregnancy, this vaccine should be used only when||
1882|083|P|clearly needed. Discuss the risks and benefits with your health||
1882|084|P|care professional.||
1882|085|P|   It is unknown if this vaccine passes into breast milk. Consult||
1882|086|P|your health care professional before breastfeeding.||
1882|087|B|||
1882|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1882|089|I|medications work or increase your risk for serious side effects.||
1882|090|I|This document does not contain all possible drug interactions.||
1882|091|I|Keep a list of all the products you use (including||
1882|092|I|prescription/nonprescription drugs and herbal products) and share||
1882|093|I|it with your health care professional. Do not start, stop, or||
1882|094|I|change the dosage of any medicines without your doctor's||
1882|095|I|approval.||
1882|096|I|   Some products that may interact with this vaccine are: drugs||
1882|097|I|that weaken the immune system (including cyclosporine,||
1882|098|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
1882|099|I|prednisone).||
1882|100|B|||
1882|101|O|OVERDOSE:  Not applicable.||
1882|102|B|||
1882|103|N|NOTES:  Keep all medical and lab appointments.||
1882|104|N|   Keep vaccine records for yourself and your children and||
1882|105|N|provide them to the health care professionals to prevent||
1882|106|N|unnecessary re-vaccinations.||
1882|107|B|||
1882|108|D|MISSED DOSE:  It is important that you receive each vaccination||
1882|109|D|as scheduled. Ask when you should get each dose and mark your||
1882|110|D|calendar with a reminder. If you miss a dose, call the health||
1882|111|D|care professional to reschedule.||
1882|112|B|||
1882|113|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
1882|114|R|light. Keep all medications away from children and pets.||
1882|115|R|   Do not flush medications down the toilet or pour them into a||
1882|116|R|drain unless instructed to do so. Properly discard this product||
1882|117|R|when it is expired or no longer needed. Consult your pharmacist||
1882|118|R|or local waste disposal company.||
1882|119|B|||
1882|120|A|Information last revised February 2025.||
1882|121|A|Copyright(c) 2025 First Databank, Inc.||
1882|122|B|||
1883|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1883|002|Z|does NOT have all possible information about this product. This||
1883|003|Z|information does not assure that this product is safe, effective,||
1883|004|Z|or appropriate for you. This information is not individual||
1883|005|Z|medical advice and does not substitute for the advice of your||
1883|006|Z|health care professional. Always ask your health care||
1883|007|Z|professional for complete information about this product and your||
1883|008|Z|specific health needs.||
1883|009|B|||
1883|010|T|LEVONORGESTREL-RELEASING 4 YEAR SYSTEM - INTRAUTERINE||
1883|011|F|(LEE-voe-nor-JES-trel)||
1883|012|B|||
1883|013|U|USES:  This product is a small, flexible device that is placed in||
1883|014|U|the womb (uterus) to prevent pregnancy. It is used by women who||
1883|015|U|want to use a reversible birth control method that works for a||
1883|016|U|long time (up to 4 years). The device slowly releases a hormone||
1883|017|U|(levonorgestrel) that is similar to a hormone that women normally||
1883|018|U|make. This device and hormone helps prevent pregnancy.||
1883|019|U|   This product does not protect against sexually transmitted||
1883|020|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1883|021|U|an effective barrier method (latex or polyurethane condom/dental||
1883|022|U|dams) during sexual activity will help to decrease your risk of||
1883|023|U|infection.||
1883|024|B|||
1883|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1883|026|H|from your pharmacist before you start using this product. If you||
1883|027|H|have any questions, ask your doctor or pharmacist.||
1883|028|H|   This device is placed in your uterus by a health care||
1883|029|H|provider. It is left in place for up to 4 years. Schedule a||
1883|030|H|follow-up visit 4 to 6 weeks after the device is placed to make||
1883|031|H|sure it is still in the proper position.||
1883|032|H|   Ask your doctor if you need to use a backup form of birth||
1883|033|H|control for the first 7 days after this device is placed to||
1883|034|H|prevent pregnancy until the device has enough time to work.||
1883|035|H|   This device may sometimes move out of place or come out by||
1883|036|H|itself. After each menstrual period, check to make sure it is in||
1883|037|H|the proper position. Learn how to carefully check the position of||
1883|038|H|this device from the Patient Information Leaflet and/or your||
1883|039|H|health care provider. If it comes out or if you cannot feel the||
1883|040|H|threads, contact your doctor promptly and use a backup form of||
1883|041|H|non-hormonal birth control (such as condoms, spermicide) to||
1883|042|H|prevent pregnancy until otherwise directed by your doctor.||
1883|043|H|   If you wish to continue this method of birth control after 4||
1883|044|H|years, the used device may be removed and replaced with a new||
1883|045|H|one. Either way, the used device should be removed after 4 years.||
1883|046|H|Your health care provider can remove this device whenever you||
1883|047|H|want to stop using this method of birth control.||
1883|048|B|||
1883|049|S|SIDE EFFECTS:  Pain, bleeding, or dizziness during and after||
1883|050|S|placement of the device may occur. Cramps, irregular menstrual||
1883|051|S|periods, and vaginal bleeding between periods (spotting) may||
1883|052|S|occur, especially during the first few weeks of use. Headache,||
1883|053|S|nausea, breast tenderness, acne, or weight gain may also occur.||
1883|054|S|If any of these effects last or get worse, tell your doctor||
1883|055|S|promptly.||
1883|056|S|   After your body adjusts to this product, it is normal to have||
1883|057|S|fewer bleeding days during your menstrual periods, and some women||
1883|058|S|stop having periods altogether. This will not affect your ability||
1883|059|S|to become pregnant after stopping use of this product.||
1883|060|S|   Remember that this medication device has been prescribed||
1883|061|S|because your doctor has judged that the benefit to you is greater||
1883|062|S|than the risk of side effects. Many people using this device do||
1883|063|S|not have serious side effects.||
1883|064|S|   Tell your doctor right away if you have any serious side||
1883|065|S|effects, including: stomach/abdominal pain, vomiting, lumps in||
1883|066|S|the breast, mental/mood changes (such as new/worsening||
1883|067|S|depression), unusual changes in vaginal bleeding (such as||
1883|068|S|continuous spotting, sudden heavy bleeding, missed periods), dark||
1883|069|S|urine, yellowing eyes/skin, unusual headaches (including||
1883|070|S|headaches with vision changes/lack of coordination, worsening of||
1883|071|S|migraines, sudden/very severe headaches).||
1883|072|S|   Using an intrauterine device (IUD) may increase your risk for||
1883|073|S|a rare but serious pelvic infection (pelvic inflammatory||
1883|074|S|disease-PID), which can cause permanent damage to sex organs and||
1883|075|S|infertility. The risk is greater in women who have multiple||
1883|076|S|sexual partners, or infection with a sexually transmitted disease||
1883|077|S|(STD), or who have had PID in the past (see also Precautions||
1883|078|S|section). Tell your doctor right away if you have symptoms of||
1883|079|S|PID, including: unexplained fever/chills, lower abdominal/pelvic||
1883|080|S|pain, pain during sexual intercourse, genital sores, unusual||
1883|081|S|vaginal discharge.||
1883|082|S|   A very serious allergic reaction to this drug is rare.||
1883|083|S|However, get medical help right away if you notice any symptoms||
1883|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1883|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1883|086|S|breathing.||
1883|087|S|   This is not a complete list of possible side effects. If you||
1883|088|S|notice other effects not listed above, contact your doctor or||
1883|089|S|pharmacist.||
1883|090|S|   In the US -||
1883|091|S|   Call your doctor for medical advice about side effects. You||
1883|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1883|093|S|www.fda.gov/medwatch.||
1883|094|S|   In Canada - Call your doctor for medical advice about side||
1883|095|S|effects. You may report side effects to Health Canada at||
1883|096|S|1-866-234-2345.||
1883|097|B|||
1883|098|P|PRECAUTIONS:  Before using this medication device, tell your||
1883|099|P|doctor or pharmacist if you are allergic to levonorgestrel, or to||
1883|100|P|any other progestins (such as norethindrone, desogestrel); or if||
1883|101|P|you have any other allergies. This product may contain inactive||
1883|102|P|ingredients, which can cause allergic reactions or other||
1883|103|P|problems. Talk to your pharmacist for more details.||
1883|104|P|   Before using this product, tell your doctor or pharmacist your||
1883|105|P|medical history, especially of: recent pregnancy, current||
1883|106|P|breastfeeding, bleeding/blood disorders, high blood pressure,||
1883|107|P|abnormal breast exam, cancer (especially endometrial, cervical,||
1883|108|P|or breast cancer), depression, diabetes, severe||
1883|109|P|headaches/migraines, heart problems (such as heart valve disease,||
1883|110|P|irregular heartbeat, previous heart attack), liver disease||
1883|111|P|(including tumors), previous pregnancy outside the uterus||
1883|112|P|(ectopic pregnancy), stroke, unexplained vaginal bleeding, uterus||
1883|113|P|problems (such as fibroids, pelvic inflammatory disease-PID),||
1883|114|P|conditions that weaken the immune system/increase the risk of||
1883|115|P|infection (such as HIV, leukemia, IV drug abuse).||
1883|116|P|   If you or your partner have other sexual partners, this device||
1883|117|P|may not be the best birth control method for you. If you or your||
1883|118|P|partner get a sexually transmitted disease (including HIV,||
1883|119|P|gonorrhea, chlamydia), contact your doctor right away. Ask your||
1883|120|P|doctor if you should continue to use this device for birth||
1883|121|P|control.||
1883|122|P|   If you are going to have an MRI test, tell testing personnel||
1883|123|P|and all your doctors that you are using this device. Some brands||
1883|124|P|of this device may be safely scanned only under specific||
1883|125|P|conditions.||
1883|126|P|   Before having surgery, tell your doctor or dentist about all||
1883|127|P|the products you use (including prescription drugs,||
1883|128|P|nonprescription drugs, and herbal products).||
1883|129|P|   This device should not be used during pregnancy. If you become||
1883|130|P|pregnant or think you may be pregnant, tell your doctor right||
1883|131|P|away.||
1883|132|P|   Levonorgestrel passes into breast milk. Consult your doctor||
1883|133|P|before breastfeeding.||
1883|134|B|||
1883|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1883|136|I|medications work or increase your risk for serious side effects.||
1883|137|I|This document does not contain all possible drug interactions.||
1883|138|I|Keep a list of all the products you use (including||
1883|139|I|prescription/nonprescription drugs and herbal products) and share||
1883|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
1883|141|I|the dosage of any medicines without your doctor's approval.||
1883|142|B|||
1883|143|O|OVERDOSE:  This medication device may be harmful if swallowed. If||
1883|144|O|someone has swallowed it and has serious symptoms such as passing||
1883|145|O|out or trouble breathing, call 911. Otherwise, call a poison||
1883|146|O|control center right away. US residents can call 1-800-222-1222.||
1883|147|O|Canada residents can call 1-844-764-7669.||
1883|148|B|||
1883|149|N|NOTES:  You should have regular complete physical exams including||
1883|150|N|blood pressure, breast exam, pelvic exam, and screening for||
1883|151|N|cervical cancer (Pap smear). Follow your doctor's instructions||
1883|152|N|for examining your breasts, and report any lumps right away. Keep||
1883|153|N|all medical and lab appointments. Consult your doctor for more||
1883|154|N|details.||
1883|155|B|||
1883|156|D|MISSED DOSE:  Not applicable.||
1883|157|B|||
1883|158|R|STORAGE:  Before use, store at room temperature. Keep all||
1883|159|R|medications and medication devices away from children and pets.||
1883|160|R|   Do not flush medications down the toilet or pour them into a||
1883|161|R|drain unless instructed to do so. Properly discard this product||
1883|162|R|when it is expired or no longer needed. Consult your pharmacist||
1883|163|R|or local waste disposal company.||
1883|164|B|||
1883|165|A|Information last revised October 2025.||
1883|166|A|Copyright(c) 2025 First Databank, Inc.||
1883|167|B|||
1884|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1884|002|Z|does NOT have all possible information about this product. This||
1884|003|Z|information does not assure that this product is safe, effective,||
1884|004|Z|or appropriate for you. This information is not individual||
1884|005|Z|medical advice and does not substitute for the advice of your||
1884|006|Z|health care professional. Always ask your health care||
1884|007|Z|professional for complete information about this product and your||
1884|008|Z|specific health needs.||
1884|009|B|||
1884|010|T|ETELCALCETIDE - INJECTION||
1884|011|F|(E-tel-KAL-se-tide)||
1884|012|B|||
1884|013|C|COMMON BRAND NAME(S): Parsabiv||
1884|014|B|||
1884|015|U|USES:  This medication is used to treat increased amounts of a||
1884|016|U|certain hormone (parathyroid) in people with long-term kidney||
1884|017|U|disease who are on dialysis. Dialysis treatment usually causes||
1884|018|U|higher than normal amounts of certain substances (such as||
1884|019|U|parathyroid hormone, calcium, phosphorus) in your body. This||
1884|020|U|medication works by decreasing how much parathyroid hormone your||
1884|021|U|body makes. This effect helps lower calcium and phosphorus levels||
1884|022|U|in your blood. Having the right amounts of parathyroid hormone,||
1884|023|U|calcium, and phosphorus in your body can help prevent bone||
1884|024|U|problems.||
1884|025|B|||
1884|026|H|HOW TO USE:  This medication is given by injection into a vein as||
1884|027|H|directed by your doctor, usually 3 times each week at the end of||
1884|028|H|dialysis treatment. The dosage is based on your medical condition||
1884|029|H|and response to treatment. To reduce your risk of side effects,||
1884|030|H|your doctor may direct you to start this medication at a low dose||
1884|031|H|and gradually increase your dose. If you miss a regularly||
1884|032|H|scheduled dialysis treatment, you should not receive this||
1884|033|H|medication until the end of your next dialysis treatment.||
1884|034|H|   If your doctor is switching you from treatment with cinacalcet||
1884|035|H|(a different medication used to decrease parathyroid hormone) to||
1884|036|H|this medication, the cinacalcet should be stopped at least 7 days||
1884|037|H|before starting etelcalcetide.||
1884|038|B|||
1884|039|S|SIDE EFFECTS:  Nausea or vomiting may occur. If either of these||
1884|040|S|effects lasts or gets worse, tell your doctor or pharmacist||
1884|041|S|promptly.||
1884|042|S|   Remember that this medication has been prescribed because your||
1884|043|S|doctor has judged that the benefit to you is greater than the||
1884|044|S|risk of side effects. Many people using this medication do not||
1884|045|S|have serious side effects.||
1884|046|S|   Etelcalcetide can cause low calcium blood levels. Your doctor||
1884|047|S|will check your calcium levels before you start using this||
1884|048|S|medication and while you are using it. Tell your doctor right||
1884|049|S|away if you have any symptoms of low calcium levels, such as||
1884|050|S|numbness/tingling in the hands/feet/face, muscle spasms,||
1884|051|S|seizures, unusual tiredness, fast/irregular/pounding heartbeat.||
1884|052|S|   Tell your doctor right away if you have any serious side||
1884|053|S|effects, including: black/bloody stools, stomach/abdominal pain,||
1884|054|S|vomit that contains blood or looks like coffee grounds, symptoms||
1884|055|S|of heart failure (such as shortness of breath, swelling||
1884|056|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
1884|057|S|   Get medical help right away if you have any very serious side||
1884|058|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1884|059|S|fainting.||
1884|060|S|   A very serious allergic reaction to this drug is rare.||
1884|061|S|However, get medical help right away if you notice any symptoms||
1884|062|S|of a serious allergic reaction, including: rash, itching/swelling||
1884|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1884|064|S|breathing.||
1884|065|S|   This is not a complete list of possible side effects. If you||
1884|066|S|notice other effects not listed above, contact your doctor or||
1884|067|S|pharmacist.||
1884|068|S|   In the US -||
1884|069|S|   Call your doctor for medical advice about side effects. You||
1884|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1884|071|S|www.fda.gov/medwatch.||
1884|072|S|   In Canada - Call your doctor for medical advice about side||
1884|073|S|effects. You may report side effects to Health Canada at||
1884|074|S|1-866-234-2345.||
1884|075|B|||
1884|076|P|PRECAUTIONS:  Before receiving etelcalcetide, tell your doctor or||
1884|077|P|pharmacist if you are allergic to it; or if you have any other||
1884|078|P|allergies. This product may contain inactive ingredients, which||
1884|079|P|can cause allergic reactions or other problems. Talk to your||
1884|080|P|pharmacist for more details.||
1884|081|P|   Before using this medication, tell your doctor or pharmacist||
1884|082|P|your medical history, especially of: stomach/intestinal/esophagus||
1884|083|P|problems (such as bleeding, heartburn, ulcers), seizures.||
1884|084|P|   Etelcalcetide may cause a condition that affects the heart||
1884|085|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1884|086|P|serious (rarely fatal) fast/irregular heartbeat and other||
1884|087|P|symptoms (such as severe dizziness, fainting) that need medical||
1884|088|P|attention right away.||
1884|089|P|   The risk of QT prolongation may be increased if you have||
1884|090|P|certain medical conditions or are taking other drugs that may||
1884|091|P|cause QT prolongation. Before using etelcalcetide, tell your||
1884|092|P|doctor or pharmacist of all the drugs you take and if you have||
1884|093|P|any of the following conditions: certain heart problems (heart||
1884|094|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1884|095|P|history of certain heart problems (QT prolongation in the EKG,||
1884|096|P|sudden cardiac death).||
1884|097|P|   Low levels of potassium or magnesium in the blood may also||
1884|098|P|increase your risk of QT prolongation. This risk may increase if||
1884|099|P|you use certain drugs (such as diuretics/"water pills") or if you||
1884|100|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1884|101|P|   Before having surgery, tell your doctor or dentist about all||
1884|102|P|the products you use (including prescription drugs,||
1884|103|P|nonprescription drugs, and herbal products).||
1884|104|P|   Older adults may be more sensitive to the side effects of this||
1884|105|P|drug, especially QT prolongation (see above).||
1884|106|P|   During pregnancy, this medication should be used only when||
1884|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
1884|108|P|   It is unknown if this medication passes into breast milk.||
1884|109|P|Because of the possible risk to the infant, breastfeeding is not||
1884|110|P|recommended while using this medication. Consult your doctor||
1884|111|P|before breastfeeding.||
1884|112|B|||
1884|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1884|114|I|medications work or increase your risk for serious side effects.||
1884|115|I|This document does not contain all possible drug interactions.||
1884|116|I|Keep a list of all the products you use (including||
1884|117|I|prescription/nonprescription drugs and herbal products) and share||
1884|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
1884|119|I|the dosage of any medicines without your doctor's approval.||
1884|120|I|   This medication should not be used along with cinacalcet.||
1884|121|I|Doing so may increase the risk of side effects (especially low||
1884|122|I|calcium levels). See also How to Use section.||
1884|123|B|||
1884|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1884|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1884|126|O|poison control center right away. US residents can call||
1884|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1884|128|B|||
1884|129|N|NOTES:  Do not share this medication with others.||
1884|130|N|   Lab and/or medical tests (such as parathyroid hormone,||
1884|131|N|calcium, phosphorus levels) must be done before you start using||
1884|132|N|this medication and while you are using it. Keep all medical and||
1884|133|N|lab appointments.||
1884|134|B|||
1884|135|D|MISSED DOSE:  It is important to get each dose of this medication||
1884|136|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1884|137|D|right away for a new dosing schedule.||
1884|138|B|||
1884|139|R|STORAGE:  Not applicable. This medication is given in a hospital||
1884|140|R|or clinic or doctor's office and will not be stored at home.||
1884|141|B|||
1884|142|A|Information last revised May 2024.||
1884|143|A|Copyright(c) 2025 First Databank, Inc.||
1884|144|B|||
1885|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1885|002|Z|does NOT have all possible information about this product. This||
1885|003|Z|information does not assure that this product is safe, effective,||
1885|004|Z|or appropriate for you. This information is not individual||
1885|005|Z|medical advice and does not substitute for the advice of your||
1885|006|Z|health care professional. Always ask your health care||
1885|007|Z|professional for complete information about this product and your||
1885|008|Z|specific health needs.||
1885|009|B|||
1885|010|T|DAPAGLIFLOZIN/SAXAGLIPTIN - ORAL||
1885|011|F|(DAP-a-gli-FLOE-zin/SAX-a-GLIP-tin)||
1885|012|B|||
1885|013|C|COMMON BRAND NAME(S): Qtern||
1885|014|B|||
1885|015|U|USES:  This medication is a combination of 2 drugs: dapagliflozin||
1885|016|U|and saxagliptin. It is used with a proper diet and exercise||
1885|017|U|program to control high blood sugar in people with type 2||
1885|018|U|diabetes. Controlling high blood sugar helps prevent kidney||
1885|019|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1885|020|U|function problems. Proper control of diabetes may also lessen||
1885|021|U|your risk of a heart attack or stroke. Dapagliflozin works by||
1885|022|U|increasing the removal of sugar by your kidneys. Saxagliptin||
1885|023|U|works by increasing levels of natural substances called||
1885|024|U|incretins. Incretins help to control blood sugar by increasing||
1885|025|U|insulin release, especially after a meal. They also decrease the||
1885|026|U|amount of sugar your liver makes.||
1885|027|B|||
1885|028|H|HOW TO USE:  Read the Medication Guide provided by your||
1885|029|H|pharmacist before you start taking this medication and each time||
1885|030|H|you get a refill. If you have any questions, ask your doctor or||
1885|031|H|pharmacist.||
1885|032|H|   Take this medication by mouth with or without food as directed||
1885|033|H|by your doctor, usually once daily in the morning.||
1885|034|H|   The manufacturer directs to swallow this medication whole.||
1885|035|H|However, many similar drugs (immediate-release tablets) can be||
1885|036|H|split/crushed. Follow your doctor's directions on how to take||
1885|037|H|this medication.||
1885|038|H|   Use this medication regularly to get the most benefit from it.||
1885|039|H|To help you remember, take it at the same time each day.||
1885|040|H|   Tell your doctor if your condition does not get better or if||
1885|041|H|it gets worse (such as if your blood sugar is too high or too||
1885|042|H|low).||
1885|043|B|||
1885|044|S|SIDE EFFECTS:  Frequent urination, dizziness, or lightheadedness||
1885|045|S|may occur. If any of these effects last or get worse, tell your||
1885|046|S|doctor or pharmacist promptly.||
1885|047|S|   To reduce the risk of dizziness and lightheadedness, get up||
1885|048|S|slowly when rising from a sitting or lying position.||
1885|049|S|   Remember that this medication has been prescribed because your||
1885|050|S|doctor has judged that the benefit to you is greater than the||
1885|051|S|risk of side effects. Many people using this medication do not||
1885|052|S|have serious side effects.||
1885|053|S|   Tell your doctor right away if you have any serious side||
1885|054|S|effects, including: signs of a urinary tract infection (such as||
1885|055|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1885|056|S|signs of kidney problems (such as change in the amount of urine),||
1885|057|S|joint pain, unusual skin blisters, signs of heart failure (such||
1885|058|S|as shortness of breath, swelling ankles/feet, unusual tiredness,||
1885|059|S|unusual/sudden weight gain).||
1885|060|S|   Get medical help right away if you have any very serious side||
1885|061|S|effects, including: signs of disease of the pancreas (such as||
1885|062|S|nausea/vomiting that doesn't stop, loss of appetite,||
1885|063|S|stomach/abdominal pain which may spread to the back), unusual||
1885|064|S|tiredness, trouble breathing.||
1885|065|S|   This medication may cause a new yeast infection in the vagina||
1885|066|S|or the penis. It may also cause a rare but very serious bacterial||
1885|067|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1885|068|S|your doctor right away if you have signs of a yeast infection in||
1885|069|S|the vagina (such as unusual vaginal||
1885|070|S|discharge/burning/itching/odor) or in the penis (such as||
1885|071|S|redness/itching/swelling of the penis, unusual discharge from the||
1885|072|S|penis). However, get medical help right away if you have any||
1885|073|S|pain/redness/swelling in or around the genital/anal area, along||
1885|074|S|with a fever or feeling unwell.||
1885|075|S|   This medication does not usually cause low blood sugar||
1885|076|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1885|077|S|prescribed with other diabetes medications, or if you do not get||
1885|078|S|enough calories from food, or if you do unusually heavy exercise.||
1885|079|S|Talk with your doctor or pharmacist about whether the dose of||
1885|080|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1885|081|S|of low blood sugar include sudden sweating, shaking, fast||
1885|082|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1885|083|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1885|084|S|treat low blood sugar. If you don't have these reliable forms of||
1885|085|S|glucose, rapidly raise your blood sugar by eating a quick source||
1885|086|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1885|087|S|juice or non-diet soda. Tell your doctor right away about the||
1885|088|S|reaction and the use of this product. To help prevent low blood||
1885|089|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1885|090|S|Check with your doctor or pharmacist to find out what you should||
1885|091|S|do if you miss a meal.||
1885|092|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1885|093|S|thirst/urination. If these symptoms occur, tell your doctor right||
1885|094|S|away. Your doctor may need to adjust your diabetes medication,||
1885|095|S|exercise program, or diet.||
1885|096|S|   This medication may cause you to become dehydrated. This can||
1885|097|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1885|098|S|dehydration. Tell your doctor or pharmacist right away if you are||
1885|099|S|not able to drink fluids as usual, or losing fluid (such as due||
1885|100|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1885|101|S|right away if you have any signs of dehydration, such as||
1885|102|S|urinating less than usual, unusual dry mouth/thirst, fast||
1885|103|S|heartbeat, or dizziness/lightheadedness/fainting.||
1885|104|S|   A very serious allergic reaction to this drug is rare.||
1885|105|S|However, get medical help right away if you notice any symptoms||
1885|106|S|of a serious allergic reaction, including: rash, itching/swelling||
1885|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1885|108|S|breathing.||
1885|109|S|   This is not a complete list of possible side effects. If you||
1885|110|S|notice other effects not listed above, contact your doctor or||
1885|111|S|pharmacist.||
1885|112|S|   In the US -||
1885|113|S|   Call your doctor for medical advice about side effects. You||
1885|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1885|115|S|www.fda.gov/medwatch.||
1885|116|S|   In Canada - Call your doctor for medical advice about side||
1885|117|S|effects. You may report side effects to Health Canada at||
1885|118|S|1-866-234-2345.||
1885|119|B|||
1885|120|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1885|121|P|pharmacist if you are allergic to dapagliflozin or saxagliptin;||
1885|122|P|or if you have any other allergies. This product may contain||
1885|123|P|inactive ingredients, which can cause allergic reactions or other||
1885|124|P|problems. Talk to your pharmacist for more details.||
1885|125|P|   Before using this medication, tell your doctor or pharmacist||
1885|126|P|your medical history, especially of: kidney disease (such as||
1885|127|P|being on dialysis), dehydration, disease of the pancreas||
1885|128|P|(pancreatitis), use/abuse of alcohol, stones in your gallbladder||
1885|129|P|(gallstones), low blood pressure, heart failure, high||
1885|130|P|cholesterol, yeast infections in the vagina or penis.||
1885|131|P|   You may experience blurred vision, dizziness, or drowsiness||
1885|132|P|due to extremely low or high blood sugar. Do not drive, use||
1885|133|P|machinery, or do anything that needs alertness or clear vision||
1885|134|P|until you can do it safely.||
1885|135|P|   Limit alcohol while taking this medication because it can||
1885|136|P|increase your risk of developing low blood sugar and a high||
1885|137|P|ketone level.||
1885|138|P|   It may be harder to control your blood sugar when your body is||
1885|139|P|stressed (such as due to fever, infection, injury, or surgery).||
1885|140|P|Also, if you are eating less or not able to eat due to these||
1885|141|P|conditions or any illness, this can lead to a high ketone level||
1885|142|P|while you are taking this medication. Consult your doctor because||
1885|143|P|this may require a change in your treatment plan, medications, or||
1885|144|P|blood sugar or ketone testing.||
1885|145|P|   Before having surgery, tell your doctor or dentist about all||
1885|146|P|the products you use (including prescription drugs,||
1885|147|P|nonprescription drugs, and herbal products).||
1885|148|P|   Older adults may be more sensitive to the side effects of this||
1885|149|P|drug, especially kidney problems, dehydration, dizziness, and low||
1885|150|P|blood pressure.||
1885|151|P|   During pregnancy, this medication should be used only when||
1885|152|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1885|153|P|benefits with your doctor.||
1885|154|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1885|155|P|your doctor for managing your blood sugar while pregnant. Your||
1885|156|P|doctor may change your diabetes treatment during your pregnancy||
1885|157|P|(such as diet and medications including insulin).||
1885|158|P|   It is unknown if this drug passes into breast milk. Consult||
1885|159|P|your doctor before breastfeeding.||
1885|160|B|||
1885|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1885|162|I|medications work or increase your risk for serious side effects.||
1885|163|I|This document does not contain all possible drug interactions.||
1885|164|I|Keep a list of all the products you use (including||
1885|165|I|prescription/nonprescription drugs and herbal products) and share||
1885|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
1885|167|I|the dosage of any medicines without your doctor's approval.||
1885|168|I|   Other medications can affect the removal of saxagliptin from||
1885|169|I|your body, which may affect how saxagliptin works. Examples||
1885|170|I|include azole antifungals (such as itraconazole, ketoconazole),||
1885|171|I|nefazodone, telithromycin, ritonavir, among others.||
1885|172|I|   Beta blocker medications (such as metoprolol, propranolol,||
1885|173|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1885|174|I|heartbeat you would usually feel when your blood sugar falls too||
1885|175|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1885|176|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1885|177|I|   Many drugs can affect your blood sugar, making it harder to||
1885|178|I|control. Before you start, stop, or change any medication, talk||
1885|179|I|with your doctor or pharmacist about how the medication may||
1885|180|I|affect your blood sugar. Check your blood sugar regularly as||
1885|181|I|directed and share the results with your doctor. Tell your doctor||
1885|182|I|right away if you have symptoms of high or low blood sugar. (See||
1885|183|I|also Side Effects section.) Your doctor may need to adjust your||
1885|184|I|diabetes medication, exercise program, or diet.||
1885|185|I|   This medication may interfere with certain lab tests (such as||
1885|186|I|urine glucose test), possibly causing false test results. Make||
1885|187|I|sure lab personnel and all your doctors know you use this drug.||
1885|188|B|||
1885|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1885|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1885|191|O|poison control center right away. US residents can call||
1885|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1885|193|B|||
1885|194|N|NOTES:  Do not share this medication with others.||
1885|195|N|   Attend a diabetes education program to learn more about how to||
1885|196|N|manage your diabetes with medications, diet, exercise, and||
1885|197|N|regular medical exams.||
1885|198|N|   Learn the symptoms of high and low blood sugar and how to||
1885|199|N|treat low blood sugar. Check your blood sugar regularly as||
1885|200|N|directed.||
1885|201|N|   Lab and/or medical tests (such as kidney function, blood||
1885|202|N|pressure, blood sugar, hemoglobin A1c, cholesterol, ketones)||
1885|203|N|should be done while you are taking this medication. Keep all||
1885|204|N|medical and lab appointments. Consult your doctor for more||
1885|205|N|details.||
1885|206|B|||
1885|207|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1885|208|D|remember. If it is near the time of the next dose, skip the||
1885|209|D|missed dose. Take your next dose at the regular time. Do not||
1885|210|D|double the dose to catch up.||
1885|211|B|||
1885|212|R|STORAGE:  Store at room temperature away from light and moisture.||
1885|213|R|Do not store in the bathroom. Keep all medications away from||
1885|214|R|children and pets.||
1885|215|R|   Do not flush medications down the toilet or pour them into a||
1885|216|R|drain unless instructed to do so. Properly discard this product||
1885|217|R|when it is expired or no longer needed. Consult your pharmacist||
1885|218|R|or local waste disposal company.||
1885|219|B|||
1885|220|M|MEDICAL ALERT:  Your condition can cause complications in a||
1885|221|M|medical emergency. For information about enrolling in MedicAlert,||
1885|222|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1885|223|B|||
1885|224|A|Information last revised April 2025.||
1885|225|A|Copyright(c) 2025 First Databank, Inc.||
1885|226|B|||
1887|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1887|002|Z|does NOT have all possible information about this product. This||
1887|003|Z|information does not assure that this product is safe, effective,||
1887|004|Z|or appropriate for you. This information is not individual||
1887|005|Z|medical advice and does not substitute for the advice of your||
1887|006|Z|health care professional. Always ask your health care||
1887|007|Z|professional for complete information about this product and your||
1887|008|Z|specific health needs.||
1887|009|B|||
1887|010|T|ACALABRUTINIB CAPSULE - ORAL||
1887|011|F|(a-KAL-a-BROO-ti-nib)||
1887|012|B|||
1887|013|C|COMMON BRAND NAME(S): Calquence||
1887|014|B|||
1887|015|U|USES:  This medication is used to treat certain types of cancer||
1887|016|U|(such as mantle cell lymphoma, small lymphocytic lymphoma - SLL,||
1887|017|U|chronic lymphocytic leukemia - CLL). Acalabrutinib works by||
1887|018|U|slowing or stopping the growth of cancer cells. It belongs to a||
1887|019|U|class of drugs known as kinase inhibitors.||
1887|020|B|||
1887|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1887|022|H|from your pharmacist before you start using acalabrutinib and||
1887|023|H|each time you get a refill. If you have any questions, ask your||
1887|024|H|doctor or pharmacist.||
1887|025|H|   Take this medication by mouth with or without food as directed||
1887|026|H|by your doctor, usually two times a day (about 12 hours apart).||
1887|027|H|Swallow the capsule whole with a glass of water. Do not open,||
1887|028|H|break, or chew the capsules.||
1887|029|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1887|030|H|using this medication unless your doctor or pharmacist says you||
1887|031|H|may do so safely. Grapefruit can increase the chance of side||
1887|032|H|effects with this medicine. Ask your doctor or pharmacist for||
1887|033|H|more details.||
1887|034|H|   Medications that reduce stomach acid (such as antacids, proton||
1887|035|H|pump inhibitors/PPIs, H2 blockers) may make acalabrutinib work||
1887|036|H|less well. Do not take PPIs (such as lansoprazole, omeprazole)||
1887|037|H|while using this medication. If you take antacids, take||
1887|038|H|acalabrutinib at least 2 hours before or at least 2 hours after||
1887|039|H|taking the antacid. If you take H2 blockers (such as famotidine,||
1887|040|H|nizatidine), take acalabrutinib 2 hours before taking the H2||
1887|041|H|blocker.||
1887|042|H|   The dosage is based on your medical condition, response to||
1887|043|H|treatment, and other medications you may be taking. Be sure to||
1887|044|H|tell your doctor and pharmacist about all the products you use||
1887|045|H|(including prescription drugs, nonprescription drugs, and herbal||
1887|046|H|products).||
1887|047|H|   Do not increase your dose or use this drug more often or for||
1887|048|H|longer than prescribed. Your condition will not improve any||
1887|049|H|faster, and your risk of serious side effects will increase.||
1887|050|H|   Take this medication regularly to get the most benefit from||
1887|051|H|it. To help you remember, take it at the same times each day.||
1887|052|H|   Since this drug can be absorbed through the skin and lungs and||
1887|053|H|may harm an unborn baby, women who are pregnant or who may become||
1887|054|H|pregnant should not handle this medication or breathe the dust||
1887|055|H|from the capsules.||
1887|056|B|||
1887|057|S|SIDE EFFECTS:  Headache, nausea, vomiting, diarrhea, tiredness,||
1887|058|S|dizziness, or muscle aches may occur. If any of these effects||
1887|059|S|last or get worse, tell your doctor or pharmacist promptly.||
1887|060|S|   Remember that this medication has been prescribed because your||
1887|061|S|doctor has judged that the benefit to you is greater than the||
1887|062|S|risk of side effects. Many people using this medication do not||
1887|063|S|have serious side effects.||
1887|064|S|   Tell your doctor right away if you have any serious side||
1887|065|S|effects, including: unusual tiredness, easy or unusual bruising||
1887|066|S|or bleeding (such as nose/gum bleeds, pink/dark urine,||
1887|067|S|black/bloody stools, vomit that contains blood or looks like||
1887|068|S|coffee grounds), signs of heart problems (such as fast/irregular||
1887|069|S|heartbeat, fainting, shortness of breath, chest discomfort),||
1887|070|S|signs of liver disease (such as nausea/vomiting that doesn't||
1887|071|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
1887|072|S|eyes/skin, dark urine).||
1887|073|S|   Get medical help right away if you have any very serious side||
1887|074|S|effects, including: weakness on one side of the body, trouble||
1887|075|S|speaking, vision changes, confusion.||
1887|076|S|   This medication may lower your ability to fight infections.||
1887|077|S|This may make you more likely to get a serious (rarely fatal)||
1887|078|S|infection or make any infection you have worse. Tell your doctor||
1887|079|S|right away if you have any signs of infection (such as sore||
1887|080|S|throat that doesn't go away, fever, chills).||
1887|081|S|   Although acalabrutinib is used to treat cancer, it may rarely||
1887|082|S|increase your risk of developing other cancers (such as skin||
1887|083|S|cancer). Tell your doctor right away if you develop unusual||
1887|084|S|growths or lumps, swollen lymph nodes, sudden weight loss, night||
1887|085|S|sweats, change in appearance or size of moles, or unusual skin||
1887|086|S|changes/growth (see also Precautions section).||
1887|087|S|   A very serious allergic reaction to this drug is rare.||
1887|088|S|However, get medical help right away if you notice any symptoms||
1887|089|S|of a serious allergic reaction, including: rash, itching/swelling||
1887|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1887|091|S|breathing.||
1887|092|S|   This is not a complete list of possible side effects. If you||
1887|093|S|notice other effects not listed above, contact your doctor or||
1887|094|S|pharmacist.||
1887|095|S|   In the US -||
1887|096|S|   Call your doctor for medical advice about side effects. You||
1887|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1887|098|S|www.fda.gov/medwatch.||
1887|099|S|   In Canada - Call your doctor for medical advice about side||
1887|100|S|effects. You may report side effects to Health Canada at||
1887|101|S|1-866-234-2345.||
1887|102|B|||
1887|103|P|PRECAUTIONS:  Before taking acalabrutinib, tell your doctor or||
1887|104|P|pharmacist if you are allergic to it; or if you have any other||
1887|105|P|allergies. This product may contain inactive ingredients, which||
1887|106|P|can cause allergic reactions or other problems. Talk to your||
1887|107|P|pharmacist for more details.||
1887|108|P|   Before using this medication, tell your doctor or pharmacist||
1887|109|P|your medical history, especially of: bleeding/blood problems||
1887|110|P|(such as ulcers), fast/irregular heartbeat, recent/current||
1887|111|P|infection (including hepatitis, HIV infection), liver disease.||
1887|112|P|   This medication may increase your risk for other cancers,||
1887|113|P|including skin cancer. Limit your time in the sun. Avoid tanning||
1887|114|P|booths and sunlamps. Use sunscreen and wear protective clothing||
1887|115|P|when outdoors.||
1887|116|P|   Acalabrutinib can make you more likely to get infections or||
1887|117|P|may make current infections worse. Stay away from anyone who has||
1887|118|P|an infection that may easily spread (such as chickenpox,||
1887|119|P|COVID-19, measles, flu). Talk to your doctor if you have been||
1887|120|P|exposed to an infection or for more details.||
1887|121|P|   Tell your health care professional that you are using||
1887|122|P|acalabrutinib before having any immunizations/vaccinations. Avoid||
1887|123|P|contact with people who have recently received live vaccines||
1887|124|P|(such as flu vaccine inhaled through the nose).||
1887|125|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1887|126|P|can make you more dizzy. Do not drive, use machinery, or do||
1887|127|P|anything that needs alertness until you can do it safely. Limit||
1887|128|P|alcoholic beverages. Talk to your doctor if you are using||
1887|129|P|marijuana (cannabis).||
1887|130|P|   Before having surgery, tell your doctor or dentist about all||
1887|131|P|the products you use (including prescription drugs,||
1887|132|P|nonprescription drugs, and herbal products).||
1887|133|P|   Older adults may be more sensitive to the side effects of this||
1887|134|P|drug.||
1887|135|P|   Since this drug can be absorbed through the skin and lungs and||
1887|136|P|may harm an unborn baby, women who are pregnant or who may become||
1887|137|P|pregnant should not handle this medication or breathe the dust||
1887|138|P|from the capsules.||
1887|139|P|   Tell your doctor if you are pregnant or plan to become||
1887|140|P|pregnant. You should not become pregnant while using||
1887|141|P|acalabrutinib. Acalabrutinib may harm an unborn baby. Your doctor||
1887|142|P|should order a pregnancy test before you start this medication.||
1887|143|P|Ask about reliable forms of birth control while using this||
1887|144|P|medication and for at least one week after the last dose. If you||
1887|145|P|become pregnant, talk to your doctor right away about the risks||
1887|146|P|and benefits of this medication.||
1887|147|P|   It is unknown if this drug passes into breast milk. Because of||
1887|148|P|the possible risk to the infant, breastfeeding is not recommended||
1887|149|P|while using this drug and for at least 2 weeks after the last||
1887|150|P|dose. Consult your doctor before breastfeeding.||
1887|151|B|||
1887|152|I|DRUG INTERACTIONS:  See also How to Use section.||
1887|153|I|   Drug interactions may change how your medications work or||
1887|154|I|increase your risk for serious side effects. This document does||
1887|155|I|not contain all possible drug interactions. Keep a list of all||
1887|156|I|the products you use (including prescription/nonprescription||
1887|157|I|drugs and herbal products) and share it with your doctor and||
1887|158|I|pharmacist. Do not start, stop, or change the dosage of any||
1887|159|I|medicines without your doctor's approval.||
1887|160|I|   Other medications can affect the removal of acalabrutinib from||
1887|161|I|your body, which may affect how acalabrutinib works. Examples||
1887|162|I|include azole antifungals (such as ketoconazole, itraconazole,||
1887|163|I|voriconazole), macrolide antibiotics (such as clarithromycin,||
1887|164|I|erythromycin), HIV protease inhibitors (such as atazanavir,||
1887|165|I|nelfinavir), drugs to treat seizures (such as phenytoin,||
1887|166|I|carbamazepine, phenobarbital), nefazodone, ritonavir, St. John's||
1887|167|I|wort, telithromycin, among others.||
1887|168|B|||
1887|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1887|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1887|171|O|poison control center right away. US residents can call||
1887|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1887|173|B|||
1887|174|N|NOTES:  Do not share this medication with others.||
1887|175|N|   Lab and/or medical tests (such as liver function, complete||
1887|176|N|blood counts) should be done before you start taking this||
1887|177|N|medication and while you are taking it. Keep all medical and lab||
1887|178|N|appointments.||
1887|179|B|||
1887|180|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1887|181|D|remember. If it is more than 3 hours after the missed dose, skip||
1887|182|D|the missed dose. Take your next dose at the regular time. Do not||
1887|183|D|double the dose to catch up.||
1887|184|B|||
1887|185|R|STORAGE:  Store at room temperature away from light and moisture.||
1887|186|R|Do not store in the bathroom. Keep all medications away from||
1887|187|R|children and pets.||
1887|188|R|   Do not flush medications down the toilet or pour them into a||
1887|189|R|drain unless instructed to do so. Properly discard this product||
1887|190|R|when it is expired or no longer needed. Consult your pharmacist||
1887|191|R|or local waste disposal company.||
1887|192|B|||
1887|193|M|MEDICAL ALERT:  Your condition can cause complications in a||
1887|194|M|medical emergency. For information about enrolling in MedicAlert,||
1887|195|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1887|196|B|||
1887|197|A|Information last revised June 2025.||
1887|198|A|Copyright(c) 2025 First Databank, Inc.||
1887|199|B|||
1888|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1888|002|Z|does NOT have all possible information about this product. This||
1888|003|Z|information does not assure that this product is safe, effective,||
1888|004|Z|or appropriate for you. This information is not individual||
1888|005|Z|medical advice and does not substitute for the advice of your||
1888|006|Z|health care professional. Always ask your health care||
1888|007|Z|professional for complete information about this product and your||
1888|008|Z|specific health needs.||
1888|009|B|||
1888|010|T|BENRALIZUMAB - INJECTION||
1888|011|F|(BEN-ra-LIZ-ue-mab)||
1888|012|B|||
1888|013|C|COMMON BRAND NAME(S): Fasenra||
1888|014|B|||
1888|015|U|USES:  Benralizumab is used along with other medications to||
1888|016|U|control and prevent symptoms (such as wheezing and shortness of||
1888|017|U|breath) caused by asthma. Controlling symptoms of asthma helps||
1888|018|U|you maintain your normal activities and decreases time lost from||
1888|019|U|work or school. Benralizumab is also used to treat a certain||
1888|020|U|immune system disorder (eosinophilic granulomatosis with||
1888|021|U|polyangiitis - EGPA). This medication works by decreasing a||
1888|022|U|certain type of white blood cell (eosinophils). This effect helps||
1888|023|U|reduce swelling (inflammation) of the airways and other parts of||
1888|024|U|the body.||
1888|025|U|   This medication must be used regularly to be effective. It||
1888|026|U|does not work right away and should not be used to relieve sudden||
1888|027|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
1888|028|U|inhaler as prescribed.||
1888|029|B|||
1888|030|H|HOW TO USE:  Read the Patient Information Leaflet and||
1888|031|H|Instructions for Use if available from your pharmacist before you||
1888|032|H|start using benralizumab and each time you receive this||
1888|033|H|medication. Ask your health care professional how to prepare and||
1888|034|H|use this medication. If you have any questions, ask your doctor||
1888|035|H|or pharmacist.||
1888|036|H|   Inject this medication under the skin as directed by your||
1888|037|H|doctor. For the treatment of asthma, it is usually used once||
1888|038|H|every 4 weeks for the first 3 doses and then once every 8 weeks.||
1888|039|H|For the treatment of EGPA, it is usually used once every 4 weeks.||
1888|040|H|The injection is given in the upper arm, thigh, or abdomen.||
1888|041|H|Children's dosage is based on weight.||
1888|042|H|   If you are using the autoinjector, take it out of the||
1888|043|H|refrigerator at least 30 minutes before you inject it to allow it||
1888|044|H|to reach room temperature. Do not warm up this medication any||
1888|045|H|other way (for example, do not heat it in the microwave or place||
1888|046|H|it in hot water). Do not shake the medication. Before using,||
1888|047|H|check this product for particles or discoloration. If either is||
1888|048|H|present, do not use the liquid. Before injecting each dose, clean||
1888|049|H|the skin you are going to inject into (the injection site) with||
1888|050|H|rubbing alcohol. Change the injection site each time to lessen||
1888|051|H|injury under the skin. Do not inject into skin that is tender,||
1888|052|H|bruised, scaly, or hard. To lessen bruising, do not rub the||
1888|053|H|injection site after a shot. Learn how to store and discard||
1888|054|H|medical supplies safely.||
1888|055|H|   Serious allergic reactions can happen during or even several||
1888|056|H|days after your treatment. Careful monitoring by your doctor may||
1888|057|H|decrease your risk. If you have a serious reaction, your||
1888|058|H|treatment may be stopped. Get medical help right away if you have||
1888|059|H|swelling of face/tongue/throat, trouble breathing, rash, or||
1888|060|H|hives.||
1888|061|H|   Use this medication regularly to get the most benefit from it.||
1888|062|H|To help you remember, mark your calendar with a reminder.||
1888|063|H|   If you are regularly using a corticosteroid medication, you||
1888|064|H|should not stop using it unless directed by your doctor. Some||
1888|065|H|conditions (such as asthma, allergies) may become worse when the||
1888|066|H|drug is suddenly stopped. If you suddenly stop using the||
1888|067|H|corticosteroid medication, you may also have withdrawal symptoms||
1888|068|H|(such as weakness, weight loss, nausea, muscle pain, headache,||
1888|069|H|tiredness, dizziness). To help prevent withdrawal, your doctor||
1888|070|H|may slowly lower the dose of your corticosteroid medication after||
1888|071|H|you begin using benralizumab. Tell your doctor or pharmacist||
1888|072|H|right away if you have withdrawal.||
1888|073|H|   Tell your doctor if you do not get better or if you get worse.||
1888|074|B|||
1888|075|S|SIDE EFFECTS:  See also How to Use section.||
1888|076|S|   Headache may occur. If this effect lasts or gets worse, tell||
1888|077|S|your doctor or pharmacist promptly.||
1888|078|S|   Remember that this medication has been prescribed because your||
1888|079|S|doctor has judged that the benefit to you is greater than the||
1888|080|S|risk of side effects. Many people using this medication do not||
1888|081|S|have serious side effects.||
1888|082|S|   A very serious allergic reaction to this drug is rare.||
1888|083|S|However, get medical help right away if you notice any symptoms||
1888|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1888|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1888|086|S|breathing.||
1888|087|S|   This is not a complete list of possible side effects. If you||
1888|088|S|notice other effects not listed above, contact your doctor or||
1888|089|S|pharmacist.||
1888|090|S|   In the US -||
1888|091|S|   Call your doctor for medical advice about side effects. You||
1888|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1888|093|S|www.fda.gov/medwatch.||
1888|094|S|   In Canada - Call your doctor for medical advice about side||
1888|095|S|effects. You may report side effects to Health Canada at||
1888|096|S|1-866-234-2345.||
1888|097|B|||
1888|098|P|PRECAUTIONS:  Before using benralizumab, tell your doctor or||
1888|099|P|pharmacist if you are allergic to it; or if you have any other||
1888|100|P|allergies. This product may contain inactive ingredients, which||
1888|101|P|can cause allergic reactions or other problems. Talk to your||
1888|102|P|pharmacist for more details.||
1888|103|P|   Before using this medication, tell your doctor or pharmacist||
1888|104|P|your medical history, especially of: infection caused by worms||
1888|105|P|(helminths).||
1888|106|P|   Before having surgery, tell your doctor or dentist about all||
1888|107|P|the products you use (including prescription drugs,||
1888|108|P|nonprescription drugs, and herbal products).||
1888|109|P|   During pregnancy, this medication should be used only when||
1888|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
1888|111|P|   It is unknown if this medication passes into breast milk.||
1888|112|P|Consult your doctor before breastfeeding.||
1888|113|B|||
1888|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1888|115|I|medications work or increase your risk for serious side effects.||
1888|116|I|This document does not contain all possible drug interactions.||
1888|117|I|Keep a list of all the products you use (including||
1888|118|I|prescription/nonprescription drugs and herbal products) and share||
1888|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
1888|120|I|the dosage of any medicines without your doctor's approval.||
1888|121|B|||
1888|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1888|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1888|124|O|poison control center right away. US residents can call||
1888|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1888|126|B|||
1888|127|N|NOTES:  Do not share this medication with others.||
1888|128|N|   Keep all medical and lab appointments.||
1888|129|N|   Avoid substances that can worsen breathing problems by causing||
1888|130|N|irritation or allergic reaction, such as smoke, pollen, pet||
1888|131|N|dander, dust, and mold.||
1888|132|N|   Learn to use a peak flow meter, use it daily, and promptly||
1888|133|N|report worsening breathing problems (such as readings in the||
1888|134|N|yellow/red range, increased use of quick-relief inhalers).||
1888|135|N|   Because the flu virus can worsen breathing problems, ask your||
1888|136|N|doctor or pharmacist if you should have a flu shot every year.||
1888|137|B|||
1888|138|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1888|139|D|If it is near the time of the next dose, skip the missed dose.||
1888|140|D|Use your next dose at the regular time. Do not double the dose to||
1888|141|D|catch up.||
1888|142|B|||
1888|143|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1888|144|R|medication in the original package to protect from light. This||
1888|145|R|medication may also be stored at room temperature if needed. If||
1888|146|R|the medication is stored at room temperature, discard after 14||
1888|147|R|days. Keep all medications away from children and pets.||
1888|148|R|   Do not flush medications down the toilet or pour them into a||
1888|149|R|drain unless instructed to do so. Properly discard this product||
1888|150|R|when it is expired or no longer needed. Consult your pharmacist||
1888|151|R|or local waste disposal company.||
1888|152|B|||
1888|153|M|MEDICAL ALERT:  Your condition can cause complications in a||
1888|154|M|medical emergency. For information about enrolling in MedicAlert,||
1888|155|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1888|156|B|||
1888|157|A|Information last revised October 2024.||
1888|158|A|Copyright(c) 2025 First Databank, Inc.||
1888|159|B|||
1889|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1889|002|Z|does NOT have all possible information about this product. This||
1889|003|Z|information does not assure that this product is safe, effective,||
1889|004|Z|or appropriate for you. This information is not individual||
1889|005|Z|medical advice and does not substitute for the advice of your||
1889|006|Z|health care professional. Always ask your health care||
1889|007|Z|professional for complete information about this product and your||
1889|008|Z|specific health needs.||
1889|009|B|||
1889|010|T|BOSENTAN TABLET - FOR ORAL SUSPENSION||
1889|011|F|(boe-SEN-tan)||
1889|012|B|||
1889|013|C|COMMON BRAND NAME(S): Tracleer||
1889|014|B|||
1889|015|W|WARNING:  Bosentan may rarely cause serious (possibly fatal)||
1889|016|W|liver damage. Rarely, liver problems have happened in people||
1889|017|W|after stopping treatment with bosentan. Your doctor will perform||
1889|018|W|liver function tests before you start treatment and once a month||
1889|019|W|during treatment. Tell your doctor right away if you notice||
1889|020|W|nausea/vomiting that doesn't stop, loss of appetite,||
1889|021|W|stomach/abdominal pain, yellowing eyes/skin, or dark urine.||
1889|022|W|   This medication must not be used during pregnancy. It may harm||
1889|023|W|an unborn baby. It is important to prevent pregnancy while taking||
1889|024|W|this medication and for 1 month after treatment. Female patients||
1889|025|W|must use reliable birth control during treatment and for 1 month||
1889|026|W|after the last dose. Ask your doctor which forms of birth control||
1889|027|W|to use while taking this medication. Female patients must take a||
1889|028|W|pregnancy test before starting treatment. If you become pregnant||
1889|029|W|or think you may be pregnant, tell your doctor right away.||
1889|030|W|   To receive bosentan in the United States, you must understand,||
1889|031|W|agree to, and carefully follow the requirements of the REMS||
1889|032|W|Program for this medication. If you live in Canada or any other||
1889|033|W|country, consult your doctor and pharmacist for your country's||
1889|034|W|regulations.||
1889|035|B|||
1889|036|U|USES:  Bosentan is used to treat high blood pressure in the lungs||
1889|037|U|(pulmonary arterial hypertension). This condition is thought to||
1889|038|U|be caused by increased levels of a certain natural substance||
1889|039|U|(endothelin-1). This medication blocks the effects of||
1889|040|U|endothelin-1, which helps lower blood pressure in the lungs, slow||
1889|041|U|the worsening of symptoms from the disease, and improve your||
1889|042|U|ability to exercise.||
1889|043|B|||
1889|044|H|HOW TO USE:  Read the Medication Guide provided by your||
1889|045|H|pharmacist before you start using bosentan and each time you get||
1889|046|H|a refill. If you have any questions, ask your doctor or||
1889|047|H|pharmacist.||
1889|048|H|   Take this medication by mouth with or without food as directed||
1889|049|H|by your doctor, usually twice daily (in the morning and evening).||
1889|050|H|If half tablets are needed for your dose, break the tablets along||
1889|051|H|the score line. Do not break the tablets into quarters. Put the||
1889|052|H|tablet(s) in a small amount of water to dissolve. Once dissolved,||
1889|053|H|drink all the mixture right away. Unused half tablets may be||
1889|054|H|stored back in the opened blister for up to 7 days.||
1889|055|H|   The dosage is based on your medical condition, weight,||
1889|056|H|response to treatment, and other medications you may be taking.||
1889|057|H|Be sure to tell your doctor and pharmacist about all the products||
1889|058|H|you use (including prescription drugs, nonprescription drugs, and||
1889|059|H|herbal products).||
1889|060|H|   Use this medication regularly to get the most benefit from it.||
1889|061|H|To help you remember, take it at the same times each day.||
1889|062|H|   Do not stop taking this medication without consulting your||
1889|063|H|doctor. Some conditions may become worse when this drug is||
1889|064|H|suddenly stopped. Your dose may need to be gradually decreased.||
1889|065|H|   Since this drug can be absorbed through the skin and lungs and||
1889|066|H|may harm an unborn baby, women who are pregnant or who may become||
1889|067|H|pregnant should not handle this medication or breathe the dust||
1889|068|H|from the tablets.||
1889|069|H|   Tell your doctor if your condition does not get better or if||
1889|070|H|it gets worse.||
1889|071|B|||
1889|072|S|SIDE EFFECTS:  See also Warning section.||
1889|073|S|   Dizziness, flushing, stuffy nose, or joint pain may occur. If||
1889|074|S|any of these effects last or get worse, tell your doctor or||
1889|075|S|pharmacist promptly.||
1889|076|S|   Remember that this medication has been prescribed because your||
1889|077|S|doctor has judged that the benefit to you is greater than the||
1889|078|S|risk of side effects. Many people using this medication do not||
1889|079|S|have serious side effects.||
1889|080|S|   Tell your doctor right away if you have any serious side||
1889|081|S|effects, including: fast/pounding heartbeat, unusual tiredness,||
1889|082|S|swelling ankles/feet, unusual/sudden weight gain, fainting,||
1889|083|S|shortness of breath, coughing up blood.||
1889|084|S|   In men, this medication can decrease sperm production, which||
1889|085|S|may affect the ability to father a child. Talk to your doctor for||
1889|086|S|more details.||
1889|087|S|   A very serious allergic reaction to this drug is rare.||
1889|088|S|However, get medical help right away if you notice any symptoms||
1889|089|S|of a serious allergic reaction, including: fever, swollen lymph||
1889|090|S|nodes, rash, itching/swelling (especially of the||
1889|091|S|face/tongue/throat), severe dizziness, trouble breathing.||
1889|092|S|   This is not a complete list of possible side effects. If you||
1889|093|S|notice other effects not listed above, contact your doctor or||
1889|094|S|pharmacist.||
1889|095|S|   In the US -||
1889|096|S|   Call your doctor for medical advice about side effects. You||
1889|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1889|098|S|www.fda.gov/medwatch.||
1889|099|S|   In Canada - Call your doctor for medical advice about side||
1889|100|S|effects. You may report side effects to Health Canada at||
1889|101|S|1-866-234-2345.||
1889|102|B|||
1889|103|P|PRECAUTIONS:  Before taking bosentan, tell your doctor or||
1889|104|P|pharmacist if you are allergic to it; or if you have any other||
1889|105|P|allergies. This product may contain inactive ingredients, which||
1889|106|P|can cause allergic reactions or other problems. Talk to your||
1889|107|P|pharmacist for more details.||
1889|108|P|   Before using this medication, tell your doctor or pharmacist||
1889|109|P|your medical history, especially of: liver disease, anemia.||
1889|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1889|111|P|can make you more dizzy. Do not drive, use machinery, or do||
1889|112|P|anything that needs alertness until you can do it safely. Avoid||
1889|113|P|alcoholic beverages. Talk to your doctor if you are using||
1889|114|P|marijuana (cannabis). Alcohol may also increase the risk of||
1889|115|P|serious liver problems.||
1889|116|P|   This medication may contain aspartame. If you have||
1889|117|P|phenylketonuria (PKU) or any other condition that requires you to||
1889|118|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
1889|119|P|doctor or pharmacist about using this medication safely.||
1889|120|P|   Before having surgery, tell your doctor or dentist about all||
1889|121|P|the products you use (including prescription drugs,||
1889|122|P|nonprescription drugs, and herbal products).||
1889|123|P|   Since this drug can be absorbed through the skin and lungs and||
1889|124|P|may harm an unborn baby, women who are pregnant or who may become||
1889|125|P|pregnant should not handle this medication or breathe the dust||
1889|126|P|from the tablets.||
1889|127|P|   This medication must not be used during pregnancy. It may harm||
1889|128|P|an unborn baby. Discuss the use of reliable forms of birth||
1889|129|P|control during treatment and for 1 month after the last dose. If||
1889|130|P|you become pregnant or think you may be pregnant, tell your||
1889|131|P|doctor right away. See also Warning section.||
1889|132|P|   This medication passes into breast milk. Consult your doctor||
1889|133|P|before breastfeeding.||
1889|134|B|||
1889|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1889|136|I|medications work or increase your risk for serious side effects.||
1889|137|I|This document does not contain all possible drug interactions.||
1889|138|I|Keep a list of all the products you use (including||
1889|139|I|prescription/nonprescription drugs and herbal products) and share||
1889|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
1889|141|I|the dosage of any medicines without your doctor's approval.||
1889|142|I|   A product that may interact with this drug is: sparsentan.||
1889|143|I|   Other medications can affect the removal of bosentan from your||
1889|144|I|body, which may affect how bosentan works. Examples include||
1889|145|I|cyclosporine, HIV protease inhibitors (such as atazanavir), among||
1889|146|I|others.||
1889|147|I|   This drug can speed up the removal of other drugs from your||
1889|148|I|body, which may affect how they work. Examples of affected drugs||
1889|149|I|include daridorexant, elacestrant, glyburide, mavacamten,||
1889|150|I|quizartinib, revumenib, among others.||
1889|151|I|   This medication may decrease the effectiveness of hormonal||
1889|152|I|birth control such as pills, patch, or ring. This could cause||
1889|153|I|pregnancy. Discuss with your doctor or pharmacist about using a||
1889|154|I|reliable backup birth control method while using this medication.||
1889|155|I|Also tell your doctor if you have any new spotting or||
1889|156|I|breakthrough bleeding, because these may be signs that your birth||
1889|157|I|control is not working well.||
1889|158|B|||
1889|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1889|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1889|161|O|poison control center right away. US residents can call||
1889|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1889|163|O|Symptoms of overdose may include: severe headache, severe||
1889|164|O|dizziness, nausea, vomiting.||
1889|165|B|||
1889|166|N|NOTES:  Do not share this medication with others.||
1889|167|N|   Lab and/or medical tests (such as liver function, pregnancy||
1889|168|N|tests, hemoglobin/hematocrit) should be done before you start||
1889|169|N|taking this medication and while you are taking it. Keep all||
1889|170|N|medical and lab appointments. Consult your doctor for more||
1889|171|N|details.||
1889|172|B|||
1889|173|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1889|174|D|remember. If it is near the time of the next dose, skip the||
1889|175|D|missed dose. Take your next dose at the regular time. Do not||
1889|176|D|double the dose to catch up.||
1889|177|B|||
1889|178|R|STORAGE:  Store at room temperature away from light and moisture.||
1889|179|R|Do not store in the bathroom. Keep the tablets in the blister||
1889|180|R|package until ready to use. Tablets or half tablets from the open||
1889|181|R|blisters may be stored back in the opened blister for up to 7||
1889|182|R|days. Keep all medications away from children and pets.||
1889|183|R|   Do not flush medications down the toilet or pour them into a||
1889|184|R|drain unless instructed to do so. Properly discard this product||
1889|185|R|when it is expired or no longer needed. Consult your pharmacist||
1889|186|R|or local waste disposal company.||
1889|187|B|||
1889|188|A|Information last revised November 2025.||
1889|189|A|Copyright(c) 2025 First Databank, Inc.||
1889|190|B|||
1890|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1890|002|Z|does NOT have all possible information about this product. This||
1890|003|Z|information does not assure that this product is safe, effective,||
1890|004|Z|or appropriate for you. This information is not individual||
1890|005|Z|medical advice and does not substitute for the advice of your||
1890|006|Z|health care professional. Always ask your health care||
1890|007|Z|professional for complete information about this product and your||
1890|008|Z|specific health needs.||
1890|009|B|||
1890|010|T|HOUSE DUST MITE ALLERGEN EXTRACT - SUBLINGUAL||
1890|011|B|||
1890|012|W|WARNING:  Rarely, this medication can cause a serious (rarely||
1890|013|W|fatal) allergic reaction. Get medical help right away if you||
1890|014|W|notice any symptoms of a serious allergic reaction, including:||
1890|015|W|flushing/rash, itching/swelling (especially of the face, tongue,||
1890|016|W|throat), severe dizziness, fast/weak heartbeat, or trouble||
1890|017|W|breathing. To be sure that you do not have a serious reaction,||
1890|018|W|you will need to stay in a health care setting (such as a||
1890|019|W|doctor's office) for 30 minutes after taking this drug for the||
1890|020|W|first time so your doctor can carefully monitor you and provide||
1890|021|W|medical help if needed.||
1890|022|W|   Your doctor will also prescribe another medication||
1890|023|W|(epinephrine) to use if you have a serious allergic reaction||
1890|024|W|outside the health care setting. Read the Patient Information||
1890|025|W|Leaflet for this medication provided by your pharmacist. Learn||
1890|026|W|ahead of time when and how to use your brand of epinephrine. If||
1890|027|W|you have to use it, get medical help as soon as you have used it.||
1890|028|W|   Certain medical conditions may increase the seriousness of an||
1890|029|W|allergic reaction or your risk for an allergic reaction. These||
1890|030|W|include high blood pressure, breathing disorders such as asthma,||
1890|031|W|or heart problems such as angina/irregular heartbeat/previous||
1890|032|W|heart attack. Also, some medications (including beta blockers||
1890|033|W|such as atenolol) may make epinephrine or other rescue||
1890|034|W|medications not work as well or increase your risk for side||
1890|035|W|effects from these medications. Be sure to tell your doctor about||
1890|036|W|all the drugs you use (including prescription/nonprescription||
1890|037|W|drugs and herbal products).||
1890|038|B|||
1890|039|U|USES:  This medication is used to treat allergy to house dust||
1890|040|U|mites. It contains an extract made from certain house dust mites.||
1890|041|U|Before prescribing this medication, your doctor must do||
1890|042|U|lab/medical tests (such as skin or blood tests) to learn what you||
1890|043|U|are allergic to. This allergen extract works by making your body||
1890|044|U|less sensitive to the house dust mites that cause your allergies.||
1890|045|U|This medication will not work right away to relieve allergy||
1890|046|U|symptoms. When taken as directed, it may help relieve symptoms||
1890|047|U|such as sneezing, runny/stuffy nose, cough, or itchy/watery eyes||
1890|048|U|that are caused by allergies.||
1890|049|B|||
1890|050|H|HOW TO USE:  Read the Medication Guide provided by your||
1890|051|H|pharmacist before you start taking this medication and each time||
1890|052|H|you get a refill. If you have any questions, ask your doctor or||
1890|053|H|pharmacist.||
1890|054|H|   Take this medication by mouth without food as directed by your||
1890|055|H|doctor, usually once daily. With dry hands, remove one tablet||
1890|056|H|from the package just before taking. Place the tablet under the||
1890|057|H|tongue and allow it to dissolve (usually within 10 seconds). Do||
1890|058|H|not swallow for at least 1 minute after taking this medication.||
1890|059|H|Do not chew or swallow the tablet. Do not eat or drink while the||
1890|060|H|tablet is dissolving in your mouth and for 5 minutes after taking||
1890|061|H|it. Wash your hands after handling the tablet.||
1890|062|H|   Use this medication regularly to get the most benefit from it.||
1890|063|H|To help you remember, take it at the same time each day.||
1890|064|H|   Tell your doctor if your condition does not get better or if||
1890|065|H|it gets worse.||
1890|066|B|||
1890|067|S|SIDE EFFECTS:  Mild mouth/eye/ear/throat itching, throat||
1890|068|S|dryness/irritation, or mouth/tongue/lip swelling may occur,||
1890|069|S|especially during the first few days of treatment. Nausea, mouth||
1890|070|S|blisters, or changes in how food tastes may also occur. If any of||
1890|071|S|these effects last or get worse, tell your doctor or pharmacist||
1890|072|S|promptly.||
1890|073|S|   Remember that this medication has been prescribed because your||
1890|074|S|doctor has judged that the benefit to you is greater than the||
1890|075|S|risk of side effects. Many people using this medication do not||
1890|076|S|have serious side effects.||
1890|077|S|   Get medical help right away if you have any very serious side||
1890|078|S|effects, including: throat tightness/swelling, trouble||
1890|079|S|swallowing/breathing, voice changes (such as hoarse voice,||
1890|080|S|trouble speaking), chest pain.||
1890|081|S|   A very serious allergic reaction to this drug is rare.||
1890|082|S|However, get medical help right away if you notice any symptoms||
1890|083|S|of a serious allergic reaction (see also Warning section).||
1890|084|S|   This is not a complete list of possible side effects. If you||
1890|085|S|notice other effects not listed above, contact your doctor or||
1890|086|S|pharmacist.||
1890|087|S|   In the US -||
1890|088|S|   Call your doctor for medical advice about side effects. You||
1890|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1890|090|S|www.fda.gov/medwatch.||
1890|091|S|   In Canada - Call your doctor for medical advice about side||
1890|092|S|effects. You may report side effects to Health Canada at||
1890|093|S|1-866-234-2345.||
1890|094|B|||
1890|095|P|PRECAUTIONS:  See also Warning section.||
1890|096|P|   Before taking this medication, tell your doctor or pharmacist||
1890|097|P|if you are allergic to it; or to other allergen extracts; or if||
1890|098|P|you have any other allergies. This product may contain inactive||
1890|099|P|ingredients, which can cause allergic reactions or other||
1890|100|P|problems. Talk to your pharmacist for more details.||
1890|101|P|   Before using this medication, tell your doctor or pharmacist||
1890|102|P|your medical history, especially of: breathing disorders (such as||
1890|103|P|asthma, chronic obstructive pulmonary disease-COPD), heart||
1890|104|P|problems (such as angina, irregular heartbeat, previous heart||
1890|105|P|attack), mouth irritation (such as cold sore, ulcer, infection),||
1890|106|P|a certain esophagus problem (eosinophilic esophagitis), previous||
1890|107|P|allergic reaction, other current allergy treatments (such as||
1890|108|P|allergy shots, other allergen extracts).||
1890|109|P|   Before having surgery or a dental procedure (such as tooth||
1890|110|P|extraction), tell your doctor or dentist about all the products||
1890|111|P|you use (including prescription drugs, nonprescription drugs, and||
1890|112|P|herbal products). Your doctor or dentist may direct you to||
1890|113|P|briefly stop treatment with this medication after surgery or a||
1890|114|P|procedure. Ask your doctor or dentist for details.||
1890|115|P|   During pregnancy, this medication should be used only when||
1890|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
1890|117|P|   It is unknown if this medication passes into breast milk.||
1890|118|P|Consult your doctor before breastfeeding.||
1890|119|B|||
1890|120|I|DRUG INTERACTIONS:  See also Warning section.||
1890|121|I|   Drug interactions may change how your medications work or||
1890|122|I|increase your risk for serious side effects. This document does||
1890|123|I|not contain all possible drug interactions. Keep a list of all||
1890|124|I|the products you use (including prescription/nonprescription||
1890|125|I|drugs and herbal products) and share it with your doctor and||
1890|126|I|pharmacist. Do not start, stop, or change the dosage of any||
1890|127|I|medicines without your doctor's approval.||
1890|128|B|||
1890|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1890|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1890|131|O|poison control center right away. US residents can call||
1890|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1890|133|B|||
1890|134|N|NOTES:  Do not share this medication with others. It may harm||
1890|135|N|them, even if their symptoms are the same as yours.||
1890|136|N|   Your doctor may direct you to also use other medications (such||
1890|137|N|as antihistamines, nasal sprays for allergies) for allergy||
1890|138|N|symptoms or for mild side effects. Ask your doctor for details.||
1890|139|B|||
1890|140|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1890|141|D|remember. If it is near the time of the next dose, skip the||
1890|142|D|missed dose. Take your next dose at the regular time. Do not||
1890|143|D|double the dose to catch up.||
1890|144|B|||
1890|145|R|STORAGE:  Store at room temperature away from light and moisture.||
1890|146|R|Do not store in the bathroom. Keep all medications away from||
1890|147|R|children and pets.||
1890|148|R|   Do not flush medications down the toilet or pour them into a||
1890|149|R|drain unless instructed to do so. Properly discard this product||
1890|150|R|when it is expired or no longer needed. Consult your pharmacist||
1890|151|R|or local waste disposal company.||
1890|152|B|||
1890|153|A|Information last revised May 2024.||
1890|154|A|Copyright(c) 2025 First Databank, Inc.||
1890|155|B|||
1891|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1891|002|Z|does NOT have all possible information about this product. This||
1891|003|Z|information does not assure that this product is safe, effective,||
1891|004|Z|or appropriate for you. This information is not individual||
1891|005|Z|medical advice and does not substitute for the advice of your||
1891|006|Z|health care professional. Always ask your health care||
1891|007|Z|professional for complete information about this product and your||
1891|008|Z|specific health needs.||
1891|009|B|||
1891|010|T|EMICIZUMAB - SUBCUTANEOUS INJECTION||
1891|011|F|(EM-i-SIZ-ue-mab)||
1891|012|B|||
1891|013|C|COMMON BRAND NAME(S): Hemlibra||
1891|014|B|||
1891|015|W|WARNING:  This medication has rarely caused serious blood clots||
1891|016|W|(including thrombotic microangiopathy) when used along with||
1891|017|W|another product used to treat or prevent bleeding (activated||
1891|018|W|prothrombin complex concentrate-aPCC). The risk is higher when||
1891|019|W|aPCC has been used for 24 hours or longer and the dose has||
1891|020|W|reached a certain amount. This interaction with aPCC may last up||
1891|021|W|to 6 months after stopping emicizumab. Get medical help right||
1891|022|W|away if you develop symptoms of serious blood clots, such as||
1891|023|W|unusual decrease in the amount of urine, swelling ankles/feet,||
1891|024|W|shortness of breath/rapid breathing, chest/jaw/left arm pain,||
1891|025|W|unusual sweating, confusion, sudden dizziness/fainting,||
1891|026|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1891|027|W|trouble speaking, weakness on one side of the body, sudden vision||
1891|028|W|changes.||
1891|029|B|||
1891|030|U|USES:  This medication is used by people with a certain inherited||
1891|031|U|bleeding problem (hemophilia A) to help prevent or lessen how||
1891|032|U|often you have bleeding problems. Emicizumab belongs to a class||
1891|033|U|of medications known as monoclonal antibodies. It works by||
1891|034|U|helping your blood to clot normally, which helps prevent bleeding||
1891|035|U|due to hemophilia A. Preventing bleeding can lessen symptoms such||
1891|036|U|as painful swellings, joint pain, pain with movement, and||
1891|037|U|difficulty walking far.||
1891|038|B|||
1891|039|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1891|040|H|provided by your pharmacist before you start using this||
1891|041|H|medication and each time you get a refill. Ask your health care||
1891|042|H|professional how to prepare and use this medication. If you have||
1891|043|H|any questions, ask your doctor or pharmacist.||
1891|044|H|   Inject this medication under the skin as directed by your||
1891|045|H|doctor, usually once a week for the first 4 weeks, followed by a||
1891|046|H|maintenance dose on a regular schedule as prescribed. The||
1891|047|H|injection is given in the thighs, upper arm, or abdomen (at least||
1891|048|H|2 inches from your belly button). The dosage is based on your||
1891|049|H|medical condition, weight, and response to treatment.||
1891|050|H|   Stop the prophylactic use of bypassing agents the day before||
1891|051|H|starting emicizumab prophylaxis. You may continue prophylaxis||
1891|052|H|with Factor VIII for the first week of emicizumab prophylaxis.||
1891|053|H|Ask your healthcare professional for more information about the||
1891|054|H|use of these other products and what to do if you have||
1891|055|H|breakthrough bleeding.||
1891|056|H|   Take the medication out of the refrigerator 15 minutes before||
1891|057|H|you inject it to allow it to reach room temperature. Do not warm||
1891|058|H|up this medication any other way (for example, do not heat it in||
1891|059|H|the microwave, place it in hot water, or leave it in direct||
1891|060|H|sunlight). Do not shake the medication. Before using, check this||
1891|061|H|product for particles or discoloration. If either is present, do||
1891|062|H|not use the liquid. Before injecting each dose, clean the skin||
1891|063|H|you are going to inject into (the injection site) with rubbing||
1891|064|H|alcohol. Change the injection site each time to lessen injury||
1891|065|H|under the skin. Do not inject into moles, scars, or skin that is||
1891|066|H|tender, bruised, red, or hard. To lessen bruising, do not rub the||
1891|067|H|injection site after a shot. Learn how to store and discard||
1891|068|H|medical supplies safely.||
1891|069|H|   Use this medication regularly to get the most benefit from it.||
1891|070|H|To help you remember, use it on the same day each week. Mark your||
1891|071|H|calendar with a reminder.||
1891|072|H|   Tell your doctor if your condition does not get better or if||
1891|073|H|it gets worse.||
1891|074|B|||
1891|075|S|SIDE EFFECTS:  See also Warning section.||
1891|076|S|   Redness, warmth, itching, or pain at the injection site may||
1891|077|S|occur. Headache or muscle/joint pain may also occur. If any of||
1891|078|S|these effects last or get worse, tell your doctor or pharmacist||
1891|079|S|promptly.||
1891|080|S|   Remember that this medication has been prescribed because your||
1891|081|S|doctor has judged that the benefit to you is greater than the||
1891|082|S|risk of side effects. Many people using this medication do not||
1891|083|S|have serious side effects.||
1891|084|S|   A very serious allergic reaction to this drug is rare.||
1891|085|S|However, get medical help right away if you notice any symptoms||
1891|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1891|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1891|088|S|breathing.||
1891|089|S|   This is not a complete list of possible side effects. If you||
1891|090|S|notice other effects not listed above, contact your doctor or||
1891|091|S|pharmacist.||
1891|092|S|   In the US -||
1891|093|S|   Call your doctor for medical advice about side effects. You||
1891|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1891|095|S|www.fda.gov/medwatch.||
1891|096|S|   In Canada - Call your doctor for medical advice about side||
1891|097|S|effects. You may report side effects to Health Canada at||
1891|098|S|1-866-234-2345.||
1891|099|B|||
1891|100|P|PRECAUTIONS:  Before using emicizumab, tell your doctor or||
1891|101|P|pharmacist if you are allergic to it; or if you have any other||
1891|102|P|allergies. This product may contain inactive ingredients, which||
1891|103|P|can cause allergic reactions or other problems. Talk to your||
1891|104|P|pharmacist for more details.||
1891|105|P|   Before using this medication, tell your doctor or pharmacist||
1891|106|P|your medical history.||
1891|107|P|   Before having surgery, tell your doctor or dentist about all||
1891|108|P|the products you use (including prescription drugs,||
1891|109|P|nonprescription drugs, and herbal products).||
1891|110|P|   During pregnancy, this medication should be used only when||
1891|111|P|clearly needed. Women of childbearing age should ask about||
1891|112|P|reliable forms of birth control while using this medication.||
1891|113|P|Discuss the risks and benefits with your doctor.||
1891|114|P|   It is unknown if this medication passes into breast milk.||
1891|115|P|Consult your doctor before breastfeeding.||
1891|116|B|||
1891|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1891|118|I|medications work or increase your risk for serious side effects.||
1891|119|I|This document does not contain all possible drug interactions.||
1891|120|I|Keep a list of all the products you use (including||
1891|121|I|prescription/nonprescription drugs and herbal products) and share||
1891|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
1891|123|I|the dosage of any medicines without your doctor's approval.||
1891|124|I|   This medication may interfere with certain lab tests (such as||
1891|125|I|blood clotting tests), possibly causing false test results. Make||
1891|126|I|sure lab personnel and all your doctors know you use this drug.||
1891|127|B|||
1891|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1891|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1891|130|O|poison control center right away. US residents can call||
1891|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1891|132|B|||
1891|133|N|NOTES:  Do not share this medication with others.||
1891|134|N|   Lab and/or medical tests (such as blood clotting tests) must||
1891|135|N|be done while you are using this medication. Keep all medical and||
1891|136|N|lab appointments.||
1891|137|B|||
1891|138|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1891|139|D|If it is near the time of the next dose, skip the missed dose.||
1891|140|D|Use your next dose at the regular time. Do not double the dose to||
1891|141|D|catch up. Do not give two doses on the same day to make up for a||
1891|142|D|missed dose.||
1891|143|B|||
1891|144|R|STORAGE:  Store in the refrigerator. Do not shake or freeze. Keep||
1891|145|R|the medication in the original package to protect from light.||
1891|146|R|Unopened vials may be taken out of the refrigerator and put back||
1891|147|R|in the refrigerator if needed. The total time out of the||
1891|148|R|refrigerator should not be more than 7 days. Keep all medications||
1891|149|R|away from children and pets.||
1891|150|R|   Do not flush medications down the toilet or pour them into a||
1891|151|R|drain unless instructed to do so. Properly discard this product||
1891|152|R|when it is expired or no longer needed. Consult your pharmacist||
1891|153|R|or local waste disposal company.||
1891|154|B|||
1891|155|M|MEDICAL ALERT:  Your condition can cause complications in a||
1891|156|M|medical emergency. For information about enrolling in MedicAlert,||
1891|157|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1891|158|B|||
1891|159|A|Information last revised October 2024.||
1891|160|A|Copyright(c) 2025 First Databank, Inc.||
1891|161|B|||
1892|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1892|002|Z|does NOT have all possible information about this product. This||
1892|003|Z|information does not assure that this product is safe, effective,||
1892|004|Z|or appropriate for you. This information is not individual||
1892|005|Z|medical advice and does not substitute for the advice of your||
1892|006|Z|health care professional. Always ask your health care||
1892|007|Z|professional for complete information about this product and your||
1892|008|Z|specific health needs.||
1892|009|B|||
1892|010|T|FACTOR IX, RECOMBINANT, PEGYLATED - INJECTION||
1892|011|F|(FAK-tor)||
1892|012|B|||
1892|013|C|COMMON BRAND NAME(S): Rebinyn||
1892|014|B|||
1892|015|U|USES:  This medication is used to prevent, treat, and control||
1892|016|U|bleeding episodes in people with little or no factor IX (due to||
1892|017|U|hemophilia B, Christmas disease). Factor IX is a protein normally||
1892|018|U|found in the blood that helps the blood to thicken (clot) and||
1892|019|U|stop bleeding. People with little or no factor IX are at risk for||
1892|020|U|bleeding longer after an injury/surgery or bleeding suddenly||
1892|021|U|(often in the joints/muscle) without an obvious cause. This||
1892|022|U|medication contains a man-made form of factor IX.||
1892|023|B|||
1892|024|H|HOW TO USE:  This medication is given by injection into a vein||
1892|025|H|over several minutes as directed by your doctor. After first||
1892|026|H|receiving this medication in a hemophilia treatment center or||
1892|027|H|hospital, some people may be able to give it to themselves at||
1892|028|H|home. If your doctor directs you to use this medication at home,||
1892|029|H|read the Patient Information Leaflet and Instructions for Use if||
1892|030|H|available from your pharmacist before you start using this||
1892|031|H|medication and each time you get a refill. Learn all preparation||
1892|032|H|and usage instructions in the product package. Learn how to store||
1892|033|H|and discard medical supplies safely. If you have any questions,||
1892|034|H|ask your health care professional.||
1892|035|H|   The medication in the vial and the supplies that come with the||
1892|036|H|medication should be used only once. Do not reuse. If the||
1892|037|H|medication and the solution used to mix it were refrigerated,||
1892|038|H|bring both to room temperature before mixing. After adding the||
1892|039|H|solution to the powder, gently swirl the mixture to completely||
1892|040|H|dissolve the powder. Do not shake. Before using, check this||
1892|041|H|product for particles or discoloration. If either is present, do||
1892|042|H|not use the liquid.||
1892|043|H|   The dosage is based on your medical condition (amount and||
1892|044|H|location of bleeding), weight, and response to treatment.||
1892|045|H|   Tell your doctor right away if your bleeding does not stop or||
1892|046|H|if this medication stops working well.||
1892|047|B|||
1892|048|S|SIDE EFFECTS:  Swelling, pain, or irritation at the injection||
1892|049|S|site may occur. If any of these effects last or get worse, tell||
1892|050|S|your doctor or pharmacist promptly.||
1892|051|S|   Remember that this medication has been prescribed because your||
1892|052|S|doctor has judged that the benefit to you is greater than the||
1892|053|S|risk of side effects. Many people using this medication do not||
1892|054|S|have serious side effects.||
1892|055|S|   Tell your doctor right away if you have any serious side||
1892|056|S|effects, including: signs of kidney disease (such as change in||
1892|057|S|the amount of urine, frothy urine, loss of appetite, tiredness,||
1892|058|S|stomach/abdominal pain, muscle loss).||
1892|059|S|   This medication may rarely cause blood clots (such as heart||
1892|060|S|attack, stroke, blood clots in the lungs or legs). Get medical||
1892|061|S|help right away if you have: shortness of breath/rapid breathing,||
1892|062|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1892|063|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1892|064|S|sudden/severe headaches, trouble speaking, weakness on one side||
1892|065|S|of the body, sudden vision changes.||
1892|066|S|   A very serious allergic reaction to this drug is rare.||
1892|067|S|However, get medical help right away if you notice any symptoms||
1892|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1892|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1892|070|S|breathing.||
1892|071|S|   This is not a complete list of possible side effects. If you||
1892|072|S|notice other effects not listed above, contact your doctor or||
1892|073|S|pharmacist.||
1892|074|S|   In the US -||
1892|075|S|   Call your doctor for medical advice about side effects. You||
1892|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1892|077|S|www.fda.gov/medwatch.||
1892|078|S|   In Canada - Call your doctor for medical advice about side||
1892|079|S|effects. You may report side effects to Health Canada at||
1892|080|S|1-866-234-2345.||
1892|081|B|||
1892|082|P|PRECAUTIONS:  Before using factor IX, tell your doctor or||
1892|083|P|pharmacist if you are allergic to factor IX products; or if you||
1892|084|P|have any other allergies. This product may contain inactive||
1892|085|P|ingredients, which can cause allergic reactions or other||
1892|086|P|problems. Talk to your pharmacist for more details.||
1892|087|P|   Before using this medication, tell your doctor or pharmacist||
1892|088|P|your medical history, especially of: other clotting disorders||
1892|089|P|(such as disseminated intravascular coagulation-DIC), recent||
1892|090|P|surgery/procedure, liver disease.||
1892|091|P|   Before having surgery, tell your doctor or dentist about all||
1892|092|P|the products you use (including prescription drugs,||
1892|093|P|nonprescription drugs, and herbal products).||
1892|094|P|   During pregnancy, this medication should be used only when||
1892|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1892|096|P|   It is unknown if this medication passes into breast milk.||
1892|097|P|Consult your doctor before breastfeeding.||
1892|098|B|||
1892|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1892|100|I|medications work or increase your risk for serious side effects.||
1892|101|I|This document does not contain all possible drug interactions.||
1892|102|I|Keep a list of all the products you use (including||
1892|103|I|prescription/nonprescription drugs and herbal products) and share||
1892|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1892|105|I|the dosage of any medicines without your doctor's approval.||
1892|106|I|   Some products that may interact with this drug are: drugs that||
1892|107|I|help with clotting (such as aminocaproic acid, tranexamic acid).||
1892|108|B|||
1892|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1892|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1892|111|O|poison control center right away. US residents can call||
1892|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1892|113|B|||
1892|114|N|NOTES:  Do not share this medication with others.||
1892|115|N|   Lab and/or medical tests (such as factor IX activity) may be||
1892|116|N|done while you are using this medication. Keep all medical and||
1892|117|N|lab appointments.||
1892|118|B|||
1892|119|D|MISSED DOSE:  If more than one dose is needed, it is important to||
1892|120|D|follow the dosing schedule as directed by your doctor. If you||
1892|121|D|miss a dose, ask your doctor or pharmacist right away for a new||
1892|122|D|dosing schedule. Do not double the dose to catch up.||
1892|123|B|||
1892|124|R|STORAGE:  Store the unmixed vial in the refrigerator. Do not||
1892|125|R|freeze. Keep the medication in the original box to protect from||
1892|126|R|light. The unmixed vial may also be stored at room temperature if||
1892|127|R|needed. If the medication is stored at room temperature, do not||
1892|128|R|put it back in the refrigerator and discard after 6 months. After||
1892|129|R|the powder is mixed into solution, use it within 4 hours and||
1892|130|R|discard any unused portion. Keep all medications away from||
1892|131|R|children and pets.||
1892|132|R|   Do not flush medications down the toilet or pour them into a||
1892|133|R|drain unless instructed to do so. Properly discard this product||
1892|134|R|when it is expired or no longer needed. Consult your pharmacist||
1892|135|R|or local waste disposal company.||
1892|136|B|||
1892|137|M|MEDICAL ALERT:  Your condition can cause complications in a||
1892|138|M|medical emergency. For information about enrolling in MedicAlert,||
1892|139|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1892|140|B|||
1892|141|A|Information last revised November 2024.||
1892|142|A|Copyright(c) 2025 First Databank, Inc.||
1892|143|B|||
1893|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1893|002|Z|does NOT have all possible information about this product. This||
1893|003|Z|information does not assure that this product is safe, effective,||
1893|004|Z|or appropriate for you. This information is not individual||
1893|005|Z|medical advice and does not substitute for the advice of your||
1893|006|Z|health care professional. Always ask your health care||
1893|007|Z|professional for complete information about this product and your||
1893|008|Z|specific health needs.||
1893|009|B|||
1893|010|T|LATANOPROSTENE BUNOD SOLUTION - OPHTHALMIC||
1893|011|F|(la-TAN-oh-PROS-teen BUE-nod)||
1893|012|B|||
1893|013|C|COMMON BRAND NAME(S): Vyzulta||
1893|014|B|||
1893|015|U|USES:  Latanoprostene bunod is used to treat high pressure inside||
1893|016|U|the eye due to glaucoma (open-angle type) or other eye diseases||
1893|017|U|(such as ocular hypertension). Lowering high pressure inside the||
1893|018|U|eye can help prevent blindness. This medication works by||
1893|019|U|controlling the flow of fluid within the eye to maintain a normal||
1893|020|U|pressure.||
1893|021|B|||
1893|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1893|023|H|directed by your doctor, usually once daily in the evening. Do||
1893|024|H|not increase your dose or use this medication more often than||
1893|025|H|prescribed. Doing so may make this medication work less well.||
1893|026|H|   To apply eye drops, wash hands first. To avoid contamination,||
1893|027|H|do not touch the dropper tip or let it touch your eye or any||
1893|028|H|other surface.||
1893|029|H|   If you are wearing contact lenses, remove them before using||
1893|030|H|eye drops. Wait at least 15 minutes before replacing your contact||
1893|031|H|lenses. Tilt your head back, look upward, and pull down the lower||
1893|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1893|033|H|and place one drop into the pouch. Look downward, gently close||
1893|034|H|your eyes, and place one finger at the corner of your eye (near||
1893|035|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
1893|036|H|opening your eyes. This will prevent the medication from draining||
1893|037|H|out. Try not to blink or rub your eye. If directed to use this||
1893|038|H|medication in both eyes, repeat these steps for your other eye.||
1893|039|H|Do not rinse the dropper. Replace the dropper cap after each use.||
1893|040|H|   If you are using another kind of eye medication (such as drops||
1893|041|H|or ointments), wait at least 5 minutes before applying other||
1893|042|H|medications. Use eye drops before eye ointments to allow the||
1893|043|H|drops to enter the eye.||
1893|044|H|   Wait several minutes for your vision to clear before driving||
1893|045|H|or operating machinery.||
1893|046|H|   Use this medication regularly to get the most benefit from it.||
1893|047|H|To help you remember, use it at the same time each day. Keep||
1893|048|H|using latanoprostene bunod even if you feel well. Most people||
1893|049|H|with glaucoma or high pressure in the eye do not have symptoms.||
1893|050|B|||
1893|051|S|SIDE EFFECTS:  Eye discomfort/irritation/redness or temporary||
1893|052|S|blurred vision may occur. If any of these effects last or get||
1893|053|S|worse, tell your doctor or pharmacist promptly.||
1893|054|S|   This medication may slowly (over months to years) cause the||
1893|055|S|colored portion of the eye (iris) to turn brown. If you are using||
1893|056|S|latanoprostene bunod in only one eye, only that iris may change||
1893|057|S|color. An increase in eyelash number/length/thickness and||
1893|058|S|darkening of the eyelashes/eyelids may also occur in the treated||
1893|059|S|eye. These changes may be permanent, but the long-term effects||
1893|060|S|are uncertain. Tell your doctor if this occurs and schedule||
1893|061|S|regular eye exams to monitor it.||
1893|062|S|   Remember that this medication has been prescribed because your||
1893|063|S|doctor has judged that the benefit to you is greater than the||
1893|064|S|risk of side effects. Many people using this medication do not||
1893|065|S|have serious side effects.||
1893|066|S|   Tell your doctor right away if you have any serious side||
1893|067|S|effects, including: vision changes, eye pain/swelling,||
1893|068|S|swelling/redness of the eyelids.||
1893|069|S|   A very serious allergic reaction to this drug is rare.||
1893|070|S|However, get medical help right away if you notice any symptoms||
1893|071|S|of a serious allergic reaction, including: rash, itching/swelling||
1893|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1893|073|S|breathing.||
1893|074|S|   This is not a complete list of possible side effects. If you||
1893|075|S|notice other effects not listed above, contact your doctor or||
1893|076|S|pharmacist.||
1893|077|S|   In the US -||
1893|078|S|   Call your doctor for medical advice about side effects. You||
1893|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1893|080|S|www.fda.gov/medwatch.||
1893|081|S|   In Canada - Call your doctor for medical advice about side||
1893|082|S|effects. You may report side effects to Health Canada at||
1893|083|S|1-866-234-2345.||
1893|084|B|||
1893|085|P|PRECAUTIONS:  Before using latanoprostene bunod, tell your doctor||
1893|086|P|or pharmacist if you are allergic to it; or if you have any other||
1893|087|P|allergies. This product may contain inactive ingredients, which||
1893|088|P|can cause allergic reactions or other problems. Talk to your||
1893|089|P|pharmacist for more details.||
1893|090|P|   Before using this medication, tell your doctor or pharmacist||
1893|091|P|your medical history, especially of: other eye problems (such as||
1893|092|P|macular edema, iritis, uveitis, lens extraction/aphakia).||
1893|093|P|   After you apply this drug, your vision may become temporarily||
1893|094|P|blurred. Do not drive, use machinery, or do anything that needs||
1893|095|P|clear vision until you can do it safely.||
1893|096|P|   Before having surgery, tell your doctor or dentist about all||
1893|097|P|the products you use (including prescription drugs,||
1893|098|P|nonprescription drugs, and herbal products).||
1893|099|P|   During pregnancy, this medication should be used only when||
1893|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
1893|101|P|   It is unknown if this drug passes into breast milk. Consult||
1893|102|P|your doctor before breastfeeding.||
1893|103|B|||
1893|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1893|105|I|medications work or increase your risk for serious side effects.||
1893|106|I|This document does not contain all possible drug interactions.||
1893|107|I|Keep a list of all the products you use (including||
1893|108|I|prescription/nonprescription drugs and herbal products) and share||
1893|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
1893|110|I|the dosage of any medicines without your doctor's approval.||
1893|111|I|   Some products that may interact with this drug are: eyelash||
1893|112|I|treatments (such as topically applied bimatoprost).||
1893|113|B|||
1893|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1893|115|O|has overdosed and has serious symptoms such as passing out or||
1893|116|O|trouble breathing, call 911. Otherwise, call a poison control||
1893|117|O|center right away. US residents can call 1-800-222-1222. Canada||
1893|118|O|residents can call 1-844-764-7669.||
1893|119|B|||
1893|120|N|NOTES:  Do not share this medication with others.||
1893|121|N|   Lab and/or medical tests (such as eye exams) may be done while||
1893|122|N|you are using this medication. Keep all medical and lab||
1893|123|N|appointments. Consult your doctor for more details.||
1893|124|B|||
1893|125|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
1893|126|D|if it is on the same day. If you do not remember until the next||
1893|127|D|day, skip the missed dose. Use your next dose at the regular||
1893|128|D|time. Do not double the dose to catch up.||
1893|129|B|||
1893|130|R|STORAGE:  Store the unopened bottles in the refrigerator away||
1893|131|R|from light. Do not freeze. Opened bottles may be stored at room||
1893|132|R|temperature away from light. Once the bottle is opened, this||
1893|133|R|medication expires after 8 weeks. Keep all medications away from||
1893|134|R|children and pets.||
1893|135|R|   Do not flush medications down the toilet or pour them into a||
1893|136|R|drain unless instructed to do so. Properly discard this product||
1893|137|R|when it is expired or no longer needed. Consult your pharmacist||
1893|138|R|or local waste disposal company.||
1893|139|B|||
1893|140|A|Information last revised September 2024.||
1893|141|A|Copyright(c) 2025 First Databank, Inc.||
1893|142|B|||
1894|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1894|002|Z|does NOT have all possible information about this product. This||
1894|003|Z|information does not assure that this product is safe, effective,||
1894|004|Z|or appropriate for you. This information is not individual||
1894|005|Z|medical advice and does not substitute for the advice of your||
1894|006|Z|health care professional. Always ask your health care||
1894|007|Z|professional for complete information about this product and your||
1894|008|Z|specific health needs.||
1894|009|B|||
1894|010|T|APREPITANT - INJECTION||
1894|011|F|(a-PRE-pi-tant)||
1894|012|B|||
1894|013|C|COMMON BRAND NAME(S): Aponvie, Cinvanti||
1894|014|B|||
1894|015|U|USES:  Aprepitant is used to prevent nausea and vomiting caused||
1894|016|U|by cancer drug treatment (chemotherapy) or surgery. It works by||
1894|017|U|blocking one of the body's natural substances (substance||
1894|018|U|P/neurokinin 1) that causes vomiting.||
1894|019|B|||
1894|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1894|021|H|from your pharmacist before you start using this medication and||
1894|022|H|each time you get a refill. If you have any questions, ask your||
1894|023|H|doctor or pharmacist.||
1894|024|H|   This medication is given by injection into a vein by a health||
1894|025|H|care professional. It is given as directed by your doctor,||
1894|026|H|usually 30 minutes before the start of chemotherapy or right||
1894|027|H|before surgery. For preventing nausea and vomiting from||
1894|028|H|chemotherapy, your doctor may direct you to also take another||
1894|029|H|form of this medication by mouth for the next 2 days. Follow your||
1894|030|H|doctor's instructions carefully. If you have any questions, ask||
1894|031|H|your doctor or pharmacist.||
1894|032|H|   Tell your doctor if you vomit or have nausea.||
1894|033|B|||
1894|034|S|SIDE EFFECTS:  Headache or tiredness may occur. Redness, itching,||
1894|035|S|bruising, and pain at the injection site may also occur. If any||
1894|036|S|of these effects last or get worse, tell your doctor or||
1894|037|S|pharmacist promptly.||
1894|038|S|   Remember that this medication has been prescribed because your||
1894|039|S|doctor has judged that the benefit to you is greater than the||
1894|040|S|risk of side effects. Many people using this medication do not||
1894|041|S|have serious side effects.||
1894|042|S|   A very serious allergic reaction to this drug is rare.||
1894|043|S|However, get medical help right away if you notice any symptoms||
1894|044|S|of a serious allergic reaction, including: rash, itching/swelling||
1894|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1894|046|S|breathing.||
1894|047|S|   This is not a complete list of possible side effects. If you||
1894|048|S|notice other effects not listed above, contact your doctor or||
1894|049|S|pharmacist.||
1894|050|S|   In the US -||
1894|051|S|   Call your doctor for medical advice about side effects. You||
1894|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1894|053|S|www.fda.gov/medwatch.||
1894|054|S|   In Canada - Call your doctor for medical advice about side||
1894|055|S|effects. You may report side effects to Health Canada at||
1894|056|S|1-866-234-2345.||
1894|057|B|||
1894|058|P|PRECAUTIONS:  Before using aprepitant, tell your doctor or||
1894|059|P|pharmacist if you are allergic to it; or to fosaprepitant; or if||
1894|060|P|you have any other allergies. This product may contain inactive||
1894|061|P|ingredients (such as alcohol), which can cause allergic reactions||
1894|062|P|or other problems. Talk to your pharmacist for more details.||
1894|063|P|   Before using this medication, tell your doctor or pharmacist||
1894|064|P|your medical history.||
1894|065|P|   Before having surgery, tell your doctor or dentist about all||
1894|066|P|the products you use (including prescription drugs,||
1894|067|P|nonprescription drugs, and herbal products).||
1894|068|P|   Tell your doctor if you are pregnant or plan to become||
1894|069|P|pregnant. You should not become pregnant while using this||
1894|070|P|medication. This form of aprepitant contains alcohol, which may||
1894|071|P|harm an unborn baby. Ask about reliable forms of birth control||
1894|072|P|while using this medication and for 1 month after the last dose.||
1894|073|P|If you become pregnant, talk to your doctor right away about the||
1894|074|P|risks and benefits of this medication.||
1894|075|P|   It is unknown if this drug passes into breast milk. Consult||
1894|076|P|your doctor before breastfeeding.||
1894|077|B|||
1894|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1894|079|I|medications work or increase your risk for serious side effects.||
1894|080|I|This document does not contain all possible drug interactions.||
1894|081|I|Keep a list of all the products you use (including||
1894|082|I|prescription/nonprescription drugs and herbal products) and share||
1894|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
1894|084|I|the dosage of any medicines without your doctor's approval.||
1894|085|I|   Aprepitant can both speed up or slow down the removal of other||
1894|086|I|medications from your body, which may affect how they work.||
1894|087|I|Examples of affected drugs include elacestrant, flibanserin,||
1894|088|I|lomitapide, pimozide, among others.||
1894|089|I|   Other medications can affect the removal of aprepitant from||
1894|090|I|your body, which may affect how aprepitant works. Examples||
1894|091|I|include azole antifungals (such as itraconazole, ketoconazole),||
1894|092|I|diltiazem, macrolide antibiotics (such as clarithromycin,||
1894|093|I|erythromycin), nefazodone, HIV protease inhibitors (such as||
1894|094|I|nelfinavir), rifamycins (such as rifampin, rifabutin), ritonavir,||
1894|095|I|St. John's wort, certain anti-seizure medicines (such as||
1894|096|I|carbamazepine, phenytoin), among others.||
1894|097|I|   If you take warfarin, this drug may affect how well warfarin||
1894|098|I|works in your body. Your doctor should test your blood during the||
1894|099|I|2-week period after you receive aprepitant to see how well||
1894|100|I|warfarin is working.||
1894|101|I|   This medication may decrease the effectiveness of hormonal||
1894|102|I|birth control such as pills, patch, or ring. This could cause||
1894|103|I|pregnancy. Ask your doctor about reliable backup birth control||
1894|104|I|during treatment and for 1 month after receiving aprepitant. Also||
1894|105|I|tell your doctor if you have any new spotting or breakthrough||
1894|106|I|bleeding, because these may be signs that your birth control is||
1894|107|I|not working well.||
1894|108|I|   Aprepitant is very similar to fosaprepitant. Do not use||
1894|109|I|fosaprepitant while using aprepitant.||
1894|110|B|||
1894|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1894|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1894|113|O|poison control center right away. US residents can call||
1894|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1894|115|B|||
1894|116|N|NOTES:  Keep all medical and lab appointments.||
1894|117|B|||
1894|118|D|MISSED DOSE:  It is important to get each dose of this medication||
1894|119|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1894|120|D|right away for a new dosing schedule.||
1894|121|B|||
1894|122|R|STORAGE:  Not applicable. This medication is given in a hospital||
1894|123|R|or clinic or doctor's office and will not be stored at home.||
1894|124|B|||
1894|125|A|Information last revised February 2025.||
1894|126|A|Copyright(c) 2025 First Databank, Inc.||
1894|127|B|||
1895|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1895|002|Z|does NOT have all possible information about this product. This||
1895|003|Z|information does not assure that this product is safe, effective,||
1895|004|Z|or appropriate for you. This information is not individual||
1895|005|Z|medical advice and does not substitute for the advice of your||
1895|006|Z|health care professional. Always ask your health care||
1895|007|Z|professional for complete information about this product and your||
1895|008|Z|specific health needs.||
1895|009|B|||
1895|010|T|DOLUTEGRAVIR/RILPIVIRINE - ORAL||
1895|011|F|(DOE-loo-TEG-ra-vir/RIL-pi-VIR-een)||
1895|012|B|||
1895|013|C|COMMON BRAND NAME(S): Juluca||
1895|014|B|||
1895|015|U|USES:  Dolutegravir/rilpivirine is used to help control HIV||
1895|016|U|infection. It helps to decrease the amount of HIV in your body so||
1895|017|U|your immune system can work better. This lowers your chance of||
1895|018|U|getting HIV complications (such as new infections, cancer) and||
1895|019|U|improves your quality of life. Dolutegravir is an integrase||
1895|020|U|inhibitor while rilpivirine is a non-nucleoside reverse||
1895|021|U|transcriptase inhibitor (NNRTI). Both drugs block the virus from||
1895|022|U|growing and infecting more cells.||
1895|023|U|   Dolutegravir/rilpivirine is not a cure for HIV infection. To||
1895|024|U|decrease your risk of spreading HIV disease to others, continue||
1895|025|U|to take all HIV medications exactly as prescribed by your doctor.||
1895|026|U|Use an effective barrier method (latex or polyurethane||
1895|027|U|condoms/dental dams) during sexual activity as directed by your||
1895|028|U|doctor. Do not share personal items (such as needles/syringes,||
1895|029|U|toothbrushes, and razors) that may have contacted blood or other||
1895|030|U|body fluids. Consult your doctor or pharmacist for more details.||
1895|031|B|||
1895|032|V|OTHER USES:  This section contains uses of this drug that are not||
1895|033|V|listed in the approved professional labeling for the drug but||
1895|034|V|that may be prescribed by your health care professional. Use this||
1895|035|V|drug for a condition that is listed in this section only if it||
1895|036|V|has been so prescribed by your health care professional.||
1895|037|V|   This product may also be used to reduce the risk of getting||
1895|038|V|HIV infection after contact with the virus. Consult your doctor||
1895|039|V|for more details.||
1895|040|B|||
1895|041|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1895|042|H|from your pharmacist before you start using||
1895|043|H|dolutegravir/rilpivirine and each time you get a refill. If you||
1895|044|H|have any questions, ask your doctor or pharmacist.||
1895|045|H|   Take this medication by mouth with a meal as directed by your||
1895|046|H|doctor, usually once daily. The dosage may be based on other||
1895|047|H|medications you are taking. Be sure to tell your doctor and||
1895|048|H|pharmacist about all the products you use (including prescription||
1895|049|H|drugs, nonprescription drugs, and herbal products).||
1895|050|H|   Medications that reduce stomach acid (such as antacids, proton||
1895|051|H|pump inhibitors/PPIs, H2 blockers) may make rilpivirine work less||
1895|052|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
1895|053|H|using this product. If you take antacids, take this product at||
1895|054|H|least 4 hours before or 6 hours after taking the antacid. If you||
1895|055|H|take H2 blockers (such as famotidine, nizatidine), take this||
1895|056|H|product at least 4 hours before or 12 hours after taking the H2||
1895|057|H|blocker.||
1895|058|H|   Sucralfate and products containing aluminum or magnesium (such||
1895|059|H|as antacids, laxatives, buffered medications) may make||
1895|060|H|dolutegravir work less well. If you take these products, take||
1895|061|H|dolutegravir/rilpivirine at least 4 hours before or 6 hours after||
1895|062|H|taking these products.||
1895|063|H|   Calcium or iron supplements (including vitamins/minerals that||
1895|064|H|contain calcium or iron) may make dolutegravir work less well. If||
1895|065|H|you take calcium or iron supplements, take||
1895|066|H|dolutegravir/rilpivirine at least 4 hours before or 6 hours after||
1895|067|H|taking calcium or iron supplements. Or you can take||
1895|068|H|dolutegravir/rilpivirine and the calcium or iron supplements||
1895|069|H|together at the same time with a meal.||
1895|070|H|   It is very important to keep taking this medication exactly as||
1895|071|H|prescribed by your doctor. Do not skip any doses.||
1895|072|H|   For the best effect, take this medication at evenly spaced||
1895|073|H|times. To help you remember, take this medication at the same||
1895|074|H|time every day.||
1895|075|H|   Do not take more or less of this drug than prescribed or stop||
1895|076|H|taking it even for a short time unless directed to do so by your||
1895|077|H|doctor. Doing so may cause the amount of virus to increase, make||
1895|078|H|the infection more difficult to treat (resistant), or worsen side||
1895|079|H|effects.||
1895|080|B|||
1895|081|S|SIDE EFFECTS:  Headache or diarrhea may occur. If either of these||
1895|082|S|effects lasts or gets worse, tell your doctor or pharmacist||
1895|083|S|promptly.||
1895|084|S|   Remember that this medication has been prescribed because your||
1895|085|S|doctor has judged that the benefit to you is greater than the||
1895|086|S|risk of side effects. Many people using this medication do not||
1895|087|S|have serious side effects.||
1895|088|S|   As your immune system gets stronger, it can begin to fight off||
1895|089|S|infections you already had, possibly causing disease symptoms to||
1895|090|S|come back. You could also have symptoms if your immune system||
1895|091|S|becomes overactive. This reaction may happen at any time (soon||
1895|092|S|after starting HIV treatment or many months later). Tell your||
1895|093|S|doctor right away if you have any serious symptoms, including:||
1895|094|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1895|095|S|that doesn't go away, headaches that are severe or don't go away,||
1895|096|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1895|097|S|changes, signs of infection (such as sore throat that doesn't go||
1895|098|S|away, fever, chills, non-healing skin sores), signs of an||
1895|099|S|overactive thyroid (such as irritability, nervousness, heat||
1895|100|S|intolerance, fast/pounding/irregular heartbeat), signs of liver||
1895|101|S|disease (such as nausea/vomiting that doesn't stop, loss of||
1895|102|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1895|103|S|urine).||
1895|104|S|   Tell your doctor right away if you have any serious side||
1895|105|S|effects, including: mental/mood changes (such as depression,||
1895|106|S|thoughts of suicide).||
1895|107|S|   Rilpivirine can commonly cause a rash that is usually not||
1895|108|S|serious. However, you may not be able to tell it apart from a||
1895|109|S|rare rash that could be a sign of a severe reaction. Get medical||
1895|110|S|help right away if you develop any rash.||
1895|111|S|   A very serious allergic reaction to this drug is rare.||
1895|112|S|However, get medical help right away if you notice any symptoms||
1895|113|S|of a serious allergic reaction, including: swollen lymph nodes,||
1895|114|S|rash, itching/swelling (especially of the face/tongue/throat),||
1895|115|S|severe dizziness, trouble breathing.||
1895|116|S|   This is not a complete list of possible side effects. If you||
1895|117|S|notice other effects not listed above, contact your doctor or||
1895|118|S|pharmacist.||
1895|119|S|   In the US -||
1895|120|S|   Call your doctor for medical advice about side effects. You||
1895|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1895|122|S|www.fda.gov/medwatch.||
1895|123|S|   In Canada - Call your doctor for medical advice about side||
1895|124|S|effects. You may report side effects to Health Canada at||
1895|125|S|1-866-234-2345.||
1895|126|B|||
1895|127|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1895|128|P|pharmacist if you are allergic to dolutegravir or rilpivirine; or||
1895|129|P|if you have any other allergies. This product may contain||
1895|130|P|inactive ingredients, which can cause allergic reactions or other||
1895|131|P|problems. Talk to your pharmacist for more details.||
1895|132|P|   Before using this medication, tell your doctor or pharmacist||
1895|133|P|your medical history, especially of: kidney disease, liver||
1895|134|P|disease (such as hepatitis B, hepatitis C), mental/mood disorders||
1895|135|P|(such as depression).||
1895|136|P|   Before having surgery, tell your doctor or dentist about all||
1895|137|P|the products you use (including prescription drugs,||
1895|138|P|nonprescription drugs, and herbal products).||
1895|139|P|   Tell your doctor if you are pregnant before using this||
1895|140|P|medication. Treatment can lower the risk of passing HIV infection||
1895|141|P|to your baby. Discuss the risks and benefits with your doctor.||
1895|142|P|   This medication passes into breast milk. Because breast milk||
1895|143|P|may transmit HIV, consult your doctor before breastfeeding.||
1895|144|B|||
1895|145|I|DRUG INTERACTIONS:  See also How to Use section.||
1895|146|I|   Drug interactions may change how your medications work or||
1895|147|I|increase your risk for serious side effects. This document does||
1895|148|I|not contain all possible drug interactions. Keep a list of all||
1895|149|I|the products you use (including prescription/nonprescription||
1895|150|I|drugs and herbal products) and share it with your doctor and||
1895|151|I|pharmacist. Do not start, stop, or change the dosage of any||
1895|152|I|medicines without your doctor's approval.||
1895|153|I|   Some products that may interact with this drug are:||
1895|154|I|dofetilide, orlistat, proton pump inhibitors (PPIs such as||
1895|155|I|esomeprazole, lansoprazole, omeprazole, pantoprazole,||
1895|156|I|rabeprazole).||
1895|157|I|   Do not take this medication with other products that treat HIV||
1895|158|I|infection. Do not take this medication with other products that||
1895|159|I|contain rilpivirine, unless you are also taking rifabutin.||
1895|160|I|   Other medications can affect the removal of rilpivirine from||
1895|161|I|your body, which may affect how rilpivirine works. Examples||
1895|162|I|include dexamethasone, certain macrolide antibiotics (such as||
1895|163|I|clarithromycin, erythromycin), rifamycins (such as rifampin,||
1895|164|I|rifapentine), St. John's wort, certain drugs used to treat||
1895|165|I|seizures (such as carbamazepine, oxcarbazepine, phenobarbital,||
1895|166|I|phenytoin, primidone), among others.||
1895|167|B|||
1895|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1895|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1895|170|O|poison control center right away. US residents can call||
1895|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1895|172|O|Symptoms of overdose may include: fast/irregular heartbeat,||
1895|173|O|severe dizziness, fainting.||
1895|174|B|||
1895|175|N|NOTES:  Do not share this medication with others.||
1895|176|N|   Lab and/or medical tests (such as viral load, T-cell counts,||
1895|177|N|liver function) should be done while you are taking this||
1895|178|N|medication. Keep all medical and lab appointments. Consult your||
1895|179|N|doctor for more details.||
1895|180|B|||
1895|181|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
1895|182|D|you remember. If it is near the time of the next dose, skip the||
1895|183|D|missed dose. Take your next dose at the regular time. Do not||
1895|184|D|double the dose to catch up.||
1895|185|B|||
1895|186|R|STORAGE:  Store in the original bottle at room temperature away||
1895|187|R|from light and moisture. Do not store in the bathroom. Keep the||
1895|188|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1895|189|R|when not in use. Keep all medications away from children and||
1895|190|R|pets.||
1895|191|R|   Do not flush medications down the toilet or pour them into a||
1895|192|R|drain unless instructed to do so. Properly discard this product||
1895|193|R|when it is expired or no longer needed. Consult your pharmacist||
1895|194|R|or local waste disposal company.||
1895|195|B|||
1895|196|A|Information last revised June 2025.||
1895|197|A|Copyright(c) 2025 First Databank, Inc.||
1895|198|B|||
1896|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1896|002|Z|does NOT have all possible information about this product. This||
1896|003|Z|information does not assure that this product is safe, effective,||
1896|004|Z|or appropriate for you. This information is not individual||
1896|005|Z|medical advice and does not substitute for the advice of your||
1896|006|Z|health care professional. Always ask your health care||
1896|007|Z|professional for complete information about this product and your||
1896|008|Z|specific health needs.||
1896|009|B|||
1896|010|T|LETERMOVIR - ORAL||
1896|011|F|(le-TERM-oh-vir)||
1896|012|B|||
1896|013|C|COMMON BRAND NAME(S): Prevymis||
1896|014|B|||
1896|015|U|USES:  This medication is used to prevent disease caused by a||
1896|016|U|virus called cytomegalovirus (CMV) in people who have received a||
1896|017|U|bone marrow transplant or kidney transplant. CMV disease can||
1896|018|U|cause serious infections, including an infection in the eye,||
1896|019|U|called CMV retinitis, that can cause blindness. Letermovir is an||
1896|020|U|anti-viral drug. It works by stopping the growth of the virus.||
1896|021|B|||
1896|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
1896|023|H|Instructions for Use if available from your pharmacist before you||
1896|024|H|start taking letermovir and each time you get a refill. If you||
1896|025|H|have any questions, ask your doctor or pharmacist.||
1896|026|H|   Take this medication by mouth with or without food, as||
1896|027|H|directed by your doctor, usually once daily. The dosage is based||
1896|028|H|on your medical condition, response to treatment, and other||
1896|029|H|medications you may be taking. Children's dosage is also based on||
1896|030|H|weight. Be sure to tell your doctor and pharmacist about all the||
1896|031|H|products you use (including prescription drugs, nonprescription||
1896|032|H|drugs, and herbal products).||
1896|033|H|   If you are taking the tablets, swallow the tablets whole. Do||
1896|034|H|not crush or chew the tablets.||
1896|035|H|   If you are taking the pellet form of this medication, open the||
1896|036|H|packet(s) and mix the entire contents of each packet with 1 to 3||
1896|037|H|teaspoons (5 to 15 milliliters) of soft food (such as applesauce,||
1896|038|H|yogurt, pudding) that is at or below room temperature. Do not use||
1896|039|H|hot food. Take the entire mixture right away. Do not crush or||
1896|040|H|chew the pellets. If you are unable to take the pellets mixed||
1896|041|H|with soft food within 10 minutes, throw it away and prepare a new||
1896|042|H|dose.||
1896|043|H|   The pellet form of this medication may also be given through a||
1896|044|H|feeding tube. If you are giving this medication through a feeding||
1896|045|H|tube, ask your health care professional for detailed instructions||
1896|046|H|on how to properly mix and give it.||
1896|047|H|   For the best effect, take this medication at evenly spaced||
1896|048|H|times. To help you remember, take this medication at the same||
1896|049|H|time every day.||
1896|050|H|   Continue to take this medication until the full prescribed||
1896|051|H|amount is finished. Stopping the medication too early may result||
1896|052|H|in an infection.||
1896|053|B|||
1896|054|S|SIDE EFFECTS:  Nausea, diarrhea, vomiting, swelling ankles/feet,||
1896|055|S|cough, or headache may occur. If any of these effects last or get||
1896|056|S|worse, tell your doctor or pharmacist promptly.||
1896|057|S|   Remember that this medication has been prescribed because your||
1896|058|S|doctor has judged that the benefit to you is greater than the||
1896|059|S|risk of side effects. Many people using this medication do not||
1896|060|S|have serious side effects.||
1896|061|S|   Tell your doctor right away if you have any serious side||
1896|062|S|effects, including: fast/irregular heartbeat.||
1896|063|S|   A very serious allergic reaction to this drug is rare.||
1896|064|S|However, get medical help right away if you notice any symptoms||
1896|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1896|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1896|067|S|breathing.||
1896|068|S|   This is not a complete list of possible side effects. If you||
1896|069|S|notice other effects not listed above, contact your doctor or||
1896|070|S|pharmacist.||
1896|071|S|   In the US -||
1896|072|S|   Call your doctor for medical advice about side effects. You||
1896|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1896|074|S|www.fda.gov/medwatch.||
1896|075|S|   In Canada - Call your doctor for medical advice about side||
1896|076|S|effects. You may report side effects to Health Canada at||
1896|077|S|1-866-234-2345.||
1896|078|B|||
1896|079|P|PRECAUTIONS:  Before taking letermovir, tell your doctor or||
1896|080|P|pharmacist if you are allergic to it; or if you have any other||
1896|081|P|allergies. This product may contain inactive ingredients, which||
1896|082|P|can cause allergic reactions or other problems. Talk to your||
1896|083|P|pharmacist for more details.||
1896|084|P|   Before using this medication, tell your doctor or pharmacist||
1896|085|P|your medical history, especially of: kidney disease, liver||
1896|086|P|disease.||
1896|087|P|   Before having surgery, tell your doctor or dentist about all||
1896|088|P|the products you use (including prescription drugs,||
1896|089|P|nonprescription drugs, and herbal products).||
1896|090|P|   During pregnancy, this medication should be used only when||
1896|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
1896|092|P|   It is unknown if this drug passes into breast milk. Consult||
1896|093|P|your doctor before breastfeeding.||
1896|094|B|||
1896|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1896|096|I|medications work or increase your risk for serious side effects.||
1896|097|I|This document does not contain all possible drug interactions.||
1896|098|I|Keep a list of all the products you use (including||
1896|099|I|prescription/nonprescription drugs and herbal products) and share||
1896|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
1896|101|I|the dosage of any medicines without your doctor's approval.||
1896|102|I|   This medication can slow down the removal of other medications||
1896|103|I|from your body, which may affect how they work. Examples of||
1896|104|I|affected drugs include elacestrant, elagolix,||
1896|105|I|elbasvir/grazoprevir, ergot alkaloids (such as ergotamine,||
1896|106|I|dihydroergotamine), flibanserin, lomitapide, pimozide, certain||
1896|107|I|statin drugs (such as pitavastatin, simvastatin), tovorafenib,||
1896|108|I|among others.||
1896|109|I|   Other medications can affect the removal of letermovir from||
1896|110|I|your body, which may affect how letermovir works. Examples||
1896|111|I|include bosentan, certain HIV NNRTIs (such as efavirenz,||
1896|112|I|etravirine, nevirapine), nafcillin, rifamycins (such as||
1896|113|I|rifabutin, rifampin), St. John's wort, thioridazine, drugs used||
1896|114|I|to treat seizures (such as carbamazepine, phenytoin), among||
1896|115|I|others.||
1896|116|B|||
1896|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1896|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1896|119|O|poison control center right away. US residents can call||
1896|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1896|121|B|||
1896|122|N|NOTES:  Do not share this medication with others.||
1896|123|N|   This medication has been prescribed for your current condition||
1896|124|N|only. Do not use it later to prevent another infection unless||
1896|125|N|your doctor tells you to.||
1896|126|B|||
1896|127|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1896|128|D|remember. If it is near the time of the next dose, skip the||
1896|129|D|missed dose. Take your next dose at the regular time. Do not||
1896|130|D|double the dose to catch up.||
1896|131|B|||
1896|132|R|STORAGE:  Store in the original package at room temperature away||
1896|133|R|from light and moisture. Do not store in the bathroom. Keep all||
1896|134|R|medications away from children and pets.||
1896|135|R|   Do not flush medications down the toilet or pour them into a||
1896|136|R|drain unless instructed to do so. Properly discard this product||
1896|137|R|when it is expired or no longer needed. Consult your pharmacist||
1896|138|R|or local waste disposal company.||
1896|139|B|||
1896|140|A|Information last revised March 2025.||
1896|141|A|Copyright(c) 2025 First Databank, Inc.||
1896|142|B|||
1897|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1897|002|Z|does NOT have all possible information about this product. This||
1897|003|Z|information does not assure that this product is safe, effective,||
1897|004|Z|or appropriate for you. This information is not individual||
1897|005|Z|medical advice and does not substitute for the advice of your||
1897|006|Z|health care professional. Always ask your health care||
1897|007|Z|professional for complete information about this product and your||
1897|008|Z|specific health needs.||
1897|009|B|||
1897|010|T|LETERMOVIR - INJECTION||
1897|011|F|(le-TERM-oh-vir)||
1897|012|B|||
1897|013|C|COMMON BRAND NAME(S): Prevymis||
1897|014|B|||
1897|015|U|USES:  This medication is used to prevent disease caused by a||
1897|016|U|virus called cytomegalovirus (CMV) in people who have received a||
1897|017|U|bone marrow transplant or kidney transplant. CMV disease can||
1897|018|U|cause serious infections, including an infection in the eye,||
1897|019|U|called CMV retinitis, that can cause blindness. Letermovir is an||
1897|020|U|anti-viral drug. It works by stopping the growth of the virus.||
1897|021|B|||
1897|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1897|023|H|from your pharmacist before you start using letermovir and each||
1897|024|H|time you get a refill. If you have any questions, ask your doctor||
1897|025|H|or pharmacist.||
1897|026|H|   This medication is given by injection into a vein, as directed||
1897|027|H|by your doctor, usually once a day over 1 hour.||
1897|028|H|   If you are using this medication at home, learn all||
1897|029|H|preparation and usage instructions from your health care||
1897|030|H|professional.||
1897|031|H|   This product may contain small white or clear particles.||
1897|032|H|Before using, check this product for cloudiness, large particles,||
1897|033|H|or discoloration. If you see any of these things, do not use the||
1897|034|H|liquid.||
1897|035|H|   Learn how to store and discard needles and medical supplies||
1897|036|H|safely.||
1897|037|H|   The dosage is based on your medical condition, response to||
1897|038|H|treatment, and other medications you may be taking. Children's||
1897|039|H|dosage is also based on weight. Be sure to tell your doctor and||
1897|040|H|pharmacist about all the products you use (including prescription||
1897|041|H|drugs, nonprescription drugs, and herbal products).||
1897|042|H|   For the best effect, use this medication at evenly spaced||
1897|043|H|times. To help you remember, use this medication at the same time||
1897|044|H|every day.||
1897|045|H|   Continue to use this medication until the full prescribed||
1897|046|H|amount is finished. Stopping the medication too early may result||
1897|047|H|in an infection.||
1897|048|B|||
1897|049|S|SIDE EFFECTS:  Nausea, diarrhea, vomiting, swelling ankles/feet,||
1897|050|S|cough, or headache may occur. If any of these effects last or get||
1897|051|S|worse, tell your doctor or pharmacist promptly.||
1897|052|S|   Remember that this medication has been prescribed because your||
1897|053|S|doctor has judged that the benefit to you is greater than the||
1897|054|S|risk of side effects. Many people using this medication do not||
1897|055|S|have serious side effects.||
1897|056|S|   Tell your doctor right away if you have any serious side||
1897|057|S|effects, including: fast/irregular heartbeat, signs of kidney||
1897|058|S|problems (such as change in the amount of urine).||
1897|059|S|   A very serious allergic reaction to this drug is rare.||
1897|060|S|However, get medical help right away if you notice any symptoms||
1897|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1897|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1897|063|S|breathing.||
1897|064|S|   This is not a complete list of possible side effects. If you||
1897|065|S|notice other effects not listed above, contact your doctor or||
1897|066|S|pharmacist.||
1897|067|S|   In the US -||
1897|068|S|   Call your doctor for medical advice about side effects. You||
1897|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1897|070|S|www.fda.gov/medwatch.||
1897|071|S|   In Canada - Call your doctor for medical advice about side||
1897|072|S|effects. You may report side effects to Health Canada at||
1897|073|S|1-866-234-2345.||
1897|074|B|||
1897|075|P|PRECAUTIONS:  Before using letermovir, tell your doctor or||
1897|076|P|pharmacist if you are allergic to it; or if you have any other||
1897|077|P|allergies. This product may contain inactive ingredients, which||
1897|078|P|can cause allergic reactions or other problems. Talk to your||
1897|079|P|pharmacist for more details.||
1897|080|P|   Before using this medication, tell your doctor or pharmacist||
1897|081|P|your medical history, especially of: kidney disease, liver||
1897|082|P|disease.||
1897|083|P|   Before having surgery, tell your doctor or dentist about all||
1897|084|P|the products you use (including prescription drugs,||
1897|085|P|nonprescription drugs, and herbal products).||
1897|086|P|   During pregnancy, this medication should be used only when||
1897|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
1897|088|P|   It is unknown if this drug passes into breast milk. Consult||
1897|089|P|your doctor before breastfeeding.||
1897|090|B|||
1897|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1897|092|I|medications work or increase your risk for serious side effects.||
1897|093|I|This document does not contain all possible drug interactions.||
1897|094|I|Keep a list of all the products you use (including||
1897|095|I|prescription/nonprescription drugs and herbal products) and share||
1897|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
1897|097|I|the dosage of any medicines without your doctor's approval.||
1897|098|I|   This medication can slow down the removal of other medications||
1897|099|I|from your body, which may affect how they work. Examples of||
1897|100|I|affected drugs include elacestrant, elagolix,||
1897|101|I|elbasvir/grazoprevir, ergot alkaloids (such as ergotamine,||
1897|102|I|dihydroergotamine), flibanserin, lomitapide, pimozide, certain||
1897|103|I|statin drugs (such as pitavastatin, simvastatin), tovorafenib,||
1897|104|I|among others.||
1897|105|I|   Other medications can affect the removal of letermovir from||
1897|106|I|your body, which may affect how letermovir works. Examples||
1897|107|I|include bosentan, certain HIV NNRTIs (such as efavirenz,||
1897|108|I|etravirine, nevirapine), nafcillin, rifamycins (such as||
1897|109|I|rifabutin, rifampin), St. John's wort, thioridazine, drugs used||
1897|110|I|to treat seizures (such as carbamazepine, phenytoin), among||
1897|111|I|others.||
1897|112|B|||
1897|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1897|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1897|115|O|poison control center right away. US residents can call||
1897|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1897|117|B|||
1897|118|N|NOTES:  Do not share this medication with others.||
1897|119|N|   This medication has been prescribed for your current condition||
1897|120|N|only. Do not use it later to prevent another infection unless||
1897|121|N|your doctor tells you to.||
1897|122|N|   Lab and/or medical tests (such as kidney function) may be done||
1897|123|N|while you are using this medication. Keep all medical and lab||
1897|124|N|appointments. Consult your doctor for more details.||
1897|125|B|||
1897|126|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1897|127|D|If it is near the time of the next dose, skip the missed dose.||
1897|128|D|Use your next dose at the regular time. Do not double the dose to||
1897|129|D|catch up.||
1897|130|B|||
1897|131|R|STORAGE:  Consult the product instructions and your pharmacist||
1897|132|R|for storage details. Keep all medications away from children and||
1897|133|R|pets.||
1897|134|R|   Do not flush medications down the toilet or pour them into a||
1897|135|R|drain unless instructed to do so. Properly discard this product||
1897|136|R|when it is expired or no longer needed. Consult your pharmacist||
1897|137|R|or local waste disposal company.||
1897|138|B|||
1897|139|A|Information last revised March 2025.||
1897|140|A|Copyright(c) 2025 First Databank, Inc.||
1897|141|B|||
1898|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1898|002|Z|does NOT have all possible information about this product. This||
1898|003|Z|information does not assure that this product is safe, effective,||
1898|004|Z|or appropriate for you. This information is not individual||
1898|005|Z|medical advice and does not substitute for the advice of your||
1898|006|Z|health care professional. Always ask your health care||
1898|007|Z|professional for complete information about this product and your||
1898|008|Z|specific health needs.||
1898|009|B|||
1898|010|T|SEMAGLUTIDE (DIABETES) - INJECTION||
1898|011|F|(SEM-a-GLOO-tide)||
1898|012|B|||
1898|013|C|COMMON BRAND NAME(S): Ozempic||
1898|014|B|||
1898|015|W|WARNING:  This medication can cause a certain type of thyroid||
1898|016|W|tumor (thyroid C-cell tumors) in rats. It is unknown if this||
1898|017|W|medication can cause similar tumors in humans. Talk with your||
1898|018|W|doctor about the benefits and risks of treatment with this||
1898|019|W|medication. Do not use this medication if you have a||
1898|020|W|personal/family history of a certain type of cancer (medullary||
1898|021|W|thyroid carcinoma) or a certain inherited disease (multiple||
1898|022|W|endocrine neoplasia syndrome type 2 or MEN 2). While using this||
1898|023|W|medication, tell your doctor right away if you notice any signs||
1898|024|W|of thyroid tumors, including an unusual growth or lump in the||
1898|025|W|neck, difficulty swallowing, shortness of breath, unusual/lasting||
1898|026|W|hoarseness.||
1898|027|B|||
1898|028|U|USES:  Semaglutide is used with a proper diet and exercise||
1898|029|U|program to control high blood sugar in people with type 2||
1898|030|U|diabetes. Controlling high blood sugar helps prevent kidney||
1898|031|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1898|032|U|function problems. Semaglutide is also used in people with type 2||
1898|033|U|diabetes and long-term kidney disease/heart disease to lower the||
1898|034|U|risk of death from heart attack or stroke. In people with||
1898|035|U|long-term kidney disease, this medication may also help slow down||
1898|036|U|the worsening of kidney disease.||
1898|037|U|   Semaglutide is similar to a natural hormone in your body||
1898|038|U|(incretin). It works by causing insulin release in response to||
1898|039|U|high blood sugar (such as after a meal) and decreasing the amount||
1898|040|U|of sugar your liver makes.||
1898|041|U|   If you use insulin, semaglutide is not a substitute for||
1898|042|U|insulin treatment.||
1898|043|B|||
1898|044|H|HOW TO USE:  Read the Medication Guide and Instructions For Use||
1898|045|H|provided by your pharmacist before you start using semaglutide||
1898|046|H|and each time you get a refill. Ask your health care professional||
1898|047|H|how to prepare and use this medication. If you have any||
1898|048|H|questions, ask your doctor or pharmacist.||
1898|049|H|   Inject this medication under the skin as directed by your||
1898|050|H|doctor, usually once every 7 days. The injection is given in the||
1898|051|H|thigh, abdomen, or upper arm. This medication may be used with or||
1898|052|H|without meals. The dosage is based on your medical condition and||
1898|053|H|response to treatment. To reduce your risk of side effects, your||
1898|054|H|doctor may direct you to start this medication at a low dose and||
1898|055|H|gradually increase your dose. Follow your doctor's instructions||
1898|056|H|carefully.||
1898|057|H|   Before using, check this product for particles or||
1898|058|H|discoloration. If either is present, do not use the liquid.||
1898|059|H|Before injecting each dose, clean the skin you are going to||
1898|060|H|inject into (the injection site) with rubbing alcohol. Change the||
1898|061|H|injection site each time to lessen injury under the skin. To||
1898|062|H|lessen bruising, do not rub the injection site after a shot.||
1898|063|H|Learn how to store and discard medical supplies safely.||
1898|064|H|   Use this medication regularly to get the most benefit from it.||
1898|065|H|To help you remember, mark your calendar with a reminder. If||
1898|066|H|needed, the day of weekly use may be changed as long as the time||
1898|067|H|between two doses is at least 2 days. Carefully follow the||
1898|068|H|medication treatment plan, meal plan, and exercise program your||
1898|069|H|doctor has recommended.||
1898|070|H|   Tell your doctor if your condition does not get better or if||
1898|071|H|it gets worse (your blood sugar is too high or too low).||
1898|072|B|||
1898|073|S|SIDE EFFECTS:  See also Warning section.||
1898|074|S|   Swelling/redness/itching at the injection site, tiredness,||
1898|075|S|nausea, vomiting, diarrhea, or constipation may occur. Nausea||
1898|076|S|usually lessens as you continue to use semaglutide. If any of||
1898|077|S|these effects last or get worse, tell your doctor or pharmacist||
1898|078|S|promptly.||
1898|079|S|   Remember that this medication has been prescribed because your||
1898|080|S|doctor has judged that the benefit to you is greater than the||
1898|081|S|risk of side effects. Many people using this medication do not||
1898|082|S|have serious side effects.||
1898|083|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
1898|084|S|Contact your doctor promptly if you notice any symptoms of||
1898|085|S|dehydration, such as unusual dry mouth/thirst, fast heartbeat, or||
1898|086|S|dizziness/lightheadedness.||
1898|087|S|   Tell your doctor right away if you have any serious side||
1898|088|S|effects, including: signs of new or worsening kidney problems||
1898|089|S|(such as change in the amount of urine), vision changes (such as||
1898|090|S|decreased/blurred vision).||
1898|091|S|   Get medical help right away if you have any very serious side||
1898|092|S|effects, including: signs of pancreas or gallbladder disease||
1898|093|S|(such as nausea/vomiting that doesn't stop, severe||
1898|094|S|stomach/abdominal pain).||
1898|095|S|   Semaglutide does not usually cause low blood sugar||
1898|096|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1898|097|S|prescribed with other diabetes medications, or if you do not get||
1898|098|S|enough calories from food, or if you do unusually heavy exercise.||
1898|099|S|Talk with your doctor or pharmacist about whether the dose of||
1898|100|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1898|101|S|of low blood sugar include sudden sweating, shaking, fast||
1898|102|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1898|103|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1898|104|S|treat low blood sugar. If you don't have these reliable forms of||
1898|105|S|glucose, rapidly raise your blood sugar by eating a quick source||
1898|106|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1898|107|S|juice or non-diet soda. Tell your doctor right away about the||
1898|108|S|reaction and the use of this product. To help prevent low blood||
1898|109|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1898|110|S|Check with your doctor or pharmacist to find out what you should||
1898|111|S|do if you miss a meal.||
1898|112|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1898|113|S|thirst/urination. If these symptoms occur, tell your doctor right||
1898|114|S|away. Your doctor may need to adjust your diabetes medication,||
1898|115|S|exercise program, or diet.||
1898|116|S|   A very serious allergic reaction to this drug is rare.||
1898|117|S|However, get medical help right away if you notice any symptoms||
1898|118|S|of a serious allergic reaction, including: rash, itching/swelling||
1898|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1898|120|S|breathing.||
1898|121|S|   This is not a complete list of possible side effects. If you||
1898|122|S|notice other effects not listed above, contact your doctor or||
1898|123|S|pharmacist.||
1898|124|S|   In the US -||
1898|125|S|   Call your doctor for medical advice about side effects. You||
1898|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1898|127|S|www.fda.gov/medwatch.||
1898|128|S|   In Canada - Call your doctor for medical advice about side||
1898|129|S|effects. You may report side effects to Health Canada at||
1898|130|S|1-866-234-2345.||
1898|131|B|||
1898|132|P|PRECAUTIONS:  See also Warning section.||
1898|133|P|   Before using semaglutide, tell your doctor or pharmacist if||
1898|134|P|you are allergic to it; or if you have any other allergies. This||
1898|135|P|product may contain inactive ingredients, which can cause||
1898|136|P|allergic reactions or other problems. Talk to your pharmacist for||
1898|137|P|more details.||
1898|138|P|   Before using this medication, tell your doctor or pharmacist||
1898|139|P|your medical history, especially of: a certain eye problem||
1898|140|P|(diabetic retinopathy), a disease of the pancreas (pancreatitis),||
1898|141|P|gallbladder disease, stomach/intestinal disorders (such as||
1898|142|P|gastroparesis, digestion problems).||
1898|143|P|   You may experience blurred vision, dizziness, or drowsiness||
1898|144|P|due to extremely low or high blood sugar. Do not drive, use||
1898|145|P|machinery, or do anything that needs alertness or clear vision||
1898|146|P|until you can do it safely.||
1898|147|P|   Limit alcohol while using this medication because it can||
1898|148|P|increase your risk of developing low blood sugar.||
1898|149|P|   It may be harder to control your blood sugar when your body is||
1898|150|P|stressed (such as due to fever, infection, injury, or surgery).||
1898|151|P|Consult your doctor because this may require a change in your||
1898|152|P|treatment plan, medications, or blood sugar testing.||
1898|153|P|   Before having surgery, tell your doctor or dentist about all||
1898|154|P|the products you use (including prescription drugs,||
1898|155|P|nonprescription drugs, and herbal products).||
1898|156|P|   During pregnancy, this medication should be used only when||
1898|157|P|clearly needed. If you are planning pregnancy, become pregnant,||
1898|158|P|or think you may be pregnant, discuss with your doctor right away||
1898|159|P|the benefits and risks of using this medication during pregnancy.||
1898|160|P|The manufacturer recommends stopping use of this medication 2||
1898|161|P|months before a planned pregnancy.||
1898|162|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1898|163|P|your doctor for managing your blood sugar while pregnant. Your||
1898|164|P|doctor may change your diabetes treatment during your pregnancy||
1898|165|P|(such as diet and medications including insulin).||
1898|166|P|   It is unknown if this medication passes into breast milk.||
1898|167|P|Consult your doctor before breastfeeding.||
1898|168|B|||
1898|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1898|170|I|medications work or increase your risk for serious side effects.||
1898|171|I|This document does not contain all possible drug interactions.||
1898|172|I|Keep a list of all the products you use (including||
1898|173|I|prescription/nonprescription drugs and herbal products) and share||
1898|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
1898|175|I|the dosage of any medicines without your doctor's approval.||
1898|176|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1898|177|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1898|178|I|heartbeat you would usually feel when your blood sugar falls too||
1898|179|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1898|180|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1898|181|I|   Many drugs can affect your blood sugar, making it harder to||
1898|182|I|control. Before you start, stop, or change any medication, talk||
1898|183|I|with your doctor or pharmacist about how the medication may||
1898|184|I|affect your blood sugar. Check your blood sugar regularly as||
1898|185|I|directed and share the results with your doctor. Tell your doctor||
1898|186|I|right away if you have symptoms of high or low blood sugar. (See||
1898|187|I|also Side Effects section.) Your doctor may need to adjust your||
1898|188|I|diabetes medication, exercise program, or diet.||
1898|189|I|   Do not use this medication with any other product that||
1898|190|I|contains semaglutide.||
1898|191|B|||
1898|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1898|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1898|194|O|poison control center right away. US residents can call||
1898|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1898|196|B|||
1898|197|N|NOTES:  Do not share this medication with others.||
1898|198|N|   Attend a diabetes education program to learn more about how to||
1898|199|N|manage your diabetes with medications, diet, exercise, and||
1898|200|N|regular medical exams.||
1898|201|N|   Learn the symptoms of high and low blood sugar and how to||
1898|202|N|treat low blood sugar. Check your blood sugar regularly as||
1898|203|N|directed.||
1898|204|N|   Lab and/or medical tests (such as kidney function, fasting||
1898|205|N|blood glucose, hemoglobin A1c) should be done while you are using||
1898|206|N|this medication. Keep all medical and lab appointments. Consult||
1898|207|N|your doctor for more details.||
1898|208|B|||
1898|209|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1898|210|D|If it is more than 5 days after the missed dose, skip the missed||
1898|211|D|dose. Use your next dose on your regular day. Do not double the||
1898|212|D|dose to catch up.||
1898|213|B|||
1898|214|R|STORAGE:  Store unused pens in the refrigerator. Do not freeze.||
1898|215|R|Once used, this product may be stored in the refrigerator or at||
1898|216|R|room temperature away from heat and light. Discard the used pen||
1898|217|R|after 8 weeks. Keep all medications away from children and pets.||
1898|218|R|   Do not flush medications down the toilet or pour them into a||
1898|219|R|drain unless instructed to do so. Properly discard this product||
1898|220|R|when it is expired or no longer needed. Consult your pharmacist||
1898|221|R|or local waste disposal company.||
1898|222|B|||
1898|223|M|MEDICAL ALERT:  Your condition can cause complications in a||
1898|224|M|medical emergency. For information about enrolling in MedicAlert,||
1898|225|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1898|226|B|||
1898|227|A|Information last revised May 2025.||
1898|228|A|Copyright(c) 2025 First Databank, Inc.||
1898|229|B|||
1899|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1899|002|Z|does NOT have all possible information about this product. This||
1899|003|Z|information does not assure that this product is safe, effective,||
1899|004|Z|or appropriate for you. This information is not individual||
1899|005|Z|medical advice and does not substitute for the advice of your||
1899|006|Z|health care professional. Always ask your health care||
1899|007|Z|professional for complete information about this product and your||
1899|008|Z|specific health needs.||
1899|009|B|||
1899|010|T|BENZOCAINE/MENTHOL SPRAY - TOPICAL||
1899|011|F|(BEN-zoe-kane/MEN-thol)||
1899|012|B|||
1899|013|C|COMMON BRAND NAME(S): Dermoplast||
1899|014|B|||
1899|015|U|USES:  This product is used on the skin for the short-term relief||
1899|016|U|of pain and itching from certain skin conditions (such as||
1899|017|U|sunburn, scrapes, minor cuts/burns/skin irritation, insect||
1899|018|U|bites). Benzocaine is a local anesthetic that works by causing||
1899|019|U|temporary numbness/loss of feeling in the skin. Menthol works by||
1899|020|U|causing the skin to feel cool and then warm to distract you from||
1899|021|U|feeling the pain and itching.||
1899|022|B|||
1899|023|H|HOW TO USE:  If you are using the over-the-counter product to||
1899|024|H|self-treat, read and follow all directions on the product package||
1899|025|H|before using this medication. If you have any questions, consult||
1899|026|H|your pharmacist. If your doctor has prescribed this medication,||
1899|027|H|use it as directed.||
1899|028|H|   Before use, clean and dry the affected area as directed. Apply||
1899|029|H|a thin layer of medication to the affected area of skin as||
1899|030|H|directed, not more than 3 to 4 times a day.||
1899|031|H|   Hold the can 6 to 12 inches (15 to 30 centimeters) from the||
1899|032|H|affected area and spray on the skin. Do not spray on your face or||
1899|033|H|in your mouth. If you need to apply this medication to your face,||
1899|034|H|spray it into the palm of your hand and gently apply it to your||
1899|035|H|face.||
1899|036|H|   Do not use on large areas of the body, cover the area with||
1899|037|H|waterproof bandages or plastic, or apply heat unless directed to||
1899|038|H|do so by your doctor. Doing so may increase the risk of serious||
1899|039|H|side effects.||
1899|040|H|   This medication is flammable until dry. Avoid smoking or being||
1899|041|H|near open flames while using the medication and until the||
1899|042|H|medication has dried.||
1899|043|H|   Wash your hands right after use unless you are treating an||
1899|044|H|area on the hands. Avoid getting the product in your eyes, nose,||
1899|045|H|or mouth. If the medication gets in these areas, rinse right away||
1899|046|H|with plenty of water.||
1899|047|H|   The dosage is based on your age, medical condition, and||
1899|048|H|response to treatment. Do not use more of this product, use it||
1899|049|H|more often, or use it longer than directed. Your condition will||
1899|050|H|not improve any faster, and your risk of side effects will||
1899|051|H|increase.||
1899|052|H|   If your condition lasts for more than 7 days, gets worse, gets||
1899|053|H|better and then comes back again in a few days, or if you think||
1899|054|H|you may have a serious medical problem, get medical help right||
1899|055|H|away.||
1899|056|B|||
1899|057|S|SIDE EFFECTS:  Temporary redness, stinging, or irritation at the||
1899|058|S|application site may occur. If any of these effects last or get||
1899|059|S|worse, tell your doctor or pharmacist promptly.||
1899|060|S|   If your doctor has directed you to use this medication,||
1899|061|S|remember that your doctor has judged that the benefit to you is||
1899|062|S|greater than the risk of side effects. Many people using this||
1899|063|S|medication do not have serious side effects.||
1899|064|S|   Get medical help right away if you have any very serious side||
1899|065|S|effects, including: slow/shallow breathing, slow/irregular||
1899|066|S|heartbeat, seizures.||
1899|067|S|   This medication has rarely caused a very serious (possibly||
1899|068|S|fatal) blood disorder (methemoglobinemia). This effect is more||
1899|069|S|likely if you have breathing problems, certain diseases of the||
1899|070|S|blood, or if you smoke (see also Precautions section). The||
1899|071|S|symptoms of this disorder may occur within minutes to a couple of||
1899|072|S|hours after using this medication. Stop using this medication and||
1899|073|S|get medical help right away if you develop any symptoms of||
1899|074|S|methemoglobinemia, including: pale/bluish/gray skin, unusual||
1899|075|S|tiredness, shortness of breath, fast heartbeat, dizziness,||
1899|076|S|headache, confusion.||
1899|077|S|   A very serious allergic reaction to this drug is rare.||
1899|078|S|However, get medical help right away if you notice any symptoms||
1899|079|S|of a serious allergic reaction, including: rash, new or worsening||
1899|080|S|itching/swelling (especially of the face/tongue/throat), severe||
1899|081|S|dizziness, trouble breathing.||
1899|082|S|   This is not a complete list of possible side effects. If you||
1899|083|S|notice other effects not listed above, contact your doctor or||
1899|084|S|pharmacist.||
1899|085|S|   In the US -||
1899|086|S|   Call your doctor for medical advice about side effects. You||
1899|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1899|088|S|www.fda.gov/medwatch.||
1899|089|S|   In Canada - Call your doctor for medical advice about side||
1899|090|S|effects. You may report side effects to Health Canada at||
1899|091|S|1-866-234-2345.||
1899|092|B|||
1899|093|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1899|094|P|pharmacist if you are allergic to benzocaine or menthol; or to||
1899|095|P|other "caine" anesthetics (such as procaine); or if you have any||
1899|096|P|other allergies. This product may contain inactive ingredients,||
1899|097|P|which can cause allergic reactions or other problems. Talk to||
1899|098|P|your pharmacist for more details.||
1899|099|P|   Before using this medication, tell your doctor or pharmacist||
1899|100|P|your medical history, especially of: certain blood disorders||
1899|101|P|(G6PD deficiency, pyruvate kinase deficiency, hemoglobin-M||
1899|102|P|disease, NADH-methemoglobin reductase deficiency), breathing||
1899|103|P|problems (such as asthma, bronchitis, emphysema, smoking||
1899|104|P|history).||
1899|105|P|   Before having surgery, tell your doctor or dentist about all||
1899|106|P|the products you use (including prescription drugs,||
1899|107|P|nonprescription drugs, and herbal products).||
1899|108|P|   During pregnancy, this medication should be used only when||
1899|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
1899|110|P|   It is unknown if this medication passes into breast milk.||
1899|111|P|Consult your doctor before breastfeeding.||
1899|112|B|||
1899|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1899|114|I|medications work or increase your risk for serious side effects.||
1899|115|I|This document does not contain all possible drug interactions.||
1899|116|I|Keep a list of all the products you use (including||
1899|117|I|prescription/nonprescription drugs and herbal products) and share||
1899|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
1899|119|I|the dosage of any medicines without your doctor's approval.||
1899|120|B|||
1899|121|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1899|122|O|has overdosed and has serious symptoms such as passing out or||
1899|123|O|trouble breathing, call 911. Otherwise, call a poison control||
1899|124|O|center right away. US residents can call 1-800-222-1222. Canada||
1899|125|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1899|126|O|include: trouble breathing, blue/gray lips or skin, irregular||
1899|127|O|heartbeat, seizures.||
1899|128|B|||
1899|129|N|NOTES:  Keep all medical and lab appointments.||
1899|130|N|   Do not spray on leather, clothing, or fabric as this product||
1899|131|N|may stain or discolor them.||
1899|132|B|||
1899|133|D|MISSED DOSE:  Not applicable.||
1899|134|B|||
1899|135|R|STORAGE:  Store at room temperature. This product is flammable||
1899|136|R|and the contents under pressure. Keep it away from heat and open||
1899|137|R|flame. Do not burn or puncture the container. Keep all||
1899|138|R|medications away from children and pets.||
1899|139|R|   Do not flush medications down the toilet or pour them into a||
1899|140|R|drain unless instructed to do so. Properly discard this product||
1899|141|R|when it is expired or no longer needed. Consult your pharmacist||
1899|142|R|or local waste disposal company.||
1899|143|B|||
1899|144|A|Information last revised July 2025.||
1899|145|A|Copyright(c) 2025 First Databank, Inc.||
1899|146|B|||
1900|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1900|002|Z|does NOT have all possible information about this product. This||
1900|003|Z|information does not assure that this product is safe, effective,||
1900|004|Z|or appropriate for you. This information is not individual||
1900|005|Z|medical advice and does not substitute for the advice of your||
1900|006|Z|health care professional. Always ask your health care||
1900|007|Z|professional for complete information about this product and your||
1900|008|Z|specific health needs.||
1900|009|B|||
1900|010|T|SECNIDAZOLE - ORAL||
1900|011|F|(sek-NID-a-zole)||
1900|012|B|||
1900|013|C|COMMON BRAND NAME(S): Solosec||
1900|014|B|||
1900|015|U|USES:  This medication is used to treat a certain type of vaginal||
1900|016|U|infection (bacterial vaginosis) in women.||
1900|017|U|   Secnidazole is also used to treat a certain common sexually||
1900|018|U|transmitted infection (trichomoniasis). If you are taking this||
1900|019|U|medication for trichomoniasis, your sexual partner(s) should be||
1900|020|U|treated at the same time.||
1900|021|U|   Secnidazole is an antibiotic that works by stopping the growth||
1900|022|U|of bacteria. This antibiotic treats only bacterial infections. It||
1900|023|U|will not work for viral infections (such as common cold, flu).||
1900|024|U|Using any antibiotic when it is not needed can cause it to not||
1900|025|U|work for future infections.||
1900|026|B|||
1900|027|H|HOW TO USE:  Read the Patient Information Leaflet and the||
1900|028|H|Instructions for Use if available from your pharmacist before you||
1900|029|H|start taking secnidazole and each time you get a refill. If you||
1900|030|H|have any questions, ask your doctor or pharmacist.||
1900|031|H|   Take this medication by mouth as directed by your doctor. This||
1900|032|H|medication is taken as a single dose.||
1900|033|H|   Open the packet and pour its contents onto applesauce, yogurt,||
1900|034|H|or pudding. Eat all of the mixture within 30 minutes without||
1900|035|H|chewing or crunching the granules. Do not prepare a supply in||
1900|036|H|advance. You may drink a glass of water afterward to help with||
1900|037|H|swallowing the medication.||
1900|038|H|   Avoid drinking alcoholic beverages and preparations that||
1900|039|H|contain ethanol or propylene glycol during treatment and for at||
1900|040|H|least 2 days after completing treatment. Doing so may make side||
1900|041|H|effects worse.||
1900|042|H|   Tell your doctor if your condition lasts or gets worse.||
1900|043|B|||
1900|044|S|SIDE EFFECTS:  Headache, nausea, diarrhea, or abdominal pain may||
1900|045|S|occur. If any of these effects last or get worse, tell your||
1900|046|S|doctor or pharmacist promptly.||
1900|047|S|   Remember that this medication has been prescribed because your||
1900|048|S|doctor has judged that the benefit to you is greater than the||
1900|049|S|risk of side effects. Many people using this medication do not||
1900|050|S|have serious side effects.||
1900|051|S|   Rarely, vaginal discomfort/itching/discharge may occur or||
1900|052|S|worsen. These symptoms may be due to a new vaginal infection||
1900|053|S|(such as a yeast/fungal infection). Contact your doctor if you||
1900|054|S|notice a change in vaginal discharge or other new vaginal||
1900|055|S|symptoms.||
1900|056|S|   A very serious allergic reaction to this drug is rare.||
1900|057|S|However, get medical help right away if you notice any symptoms||
1900|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1900|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1900|060|S|breathing.||
1900|061|S|   This is not a complete list of possible side effects. If you||
1900|062|S|notice other effects not listed above, contact your doctor or||
1900|063|S|pharmacist.||
1900|064|S|   In the US -||
1900|065|S|   Call your doctor for medical advice about side effects. You||
1900|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1900|067|S|www.fda.gov/medwatch.||
1900|068|S|   In Canada - Call your doctor for medical advice about side||
1900|069|S|effects. You may report side effects to Health Canada at||
1900|070|S|1-866-234-2345.||
1900|071|B|||
1900|072|P|PRECAUTIONS:  Before taking secnidazole, tell your doctor or||
1900|073|P|pharmacist if you are allergic to it; or to other antibiotics||
1900|074|P|(such as tinidazole); or if you have any other allergies. This||
1900|075|P|product may contain inactive ingredients, which can cause||
1900|076|P|allergic reactions or other problems. Talk to your pharmacist for||
1900|077|P|more details.||
1900|078|P|   Before using this medication, tell your doctor or pharmacist||
1900|079|P|your medical history, especially of: a certain rare genetic||
1900|080|P|disorder (Cockayne syndrome).||
1900|081|P|   If you are taking this medication to treat trichomoniasis,||
1900|082|P|avoid having sex until you and your sex partner(s) have completed||
1900|083|P|treatment and do not have any symptoms (such as vaginal||
1900|084|P|discharge, pain when urinating). Many people with trichomoniasis||
1900|085|P|do not have any symptoms, so it is important to treat all sex||
1900|086|P|partners at the same time to avoid getting infected again.||
1900|087|P|   Secnidazole may cause live bacterial vaccines (such as typhoid||
1900|088|P|vaccine) to not work well. Tell your health care professional||
1900|089|P|that you are using secnidazole before having any||
1900|090|P|immunizations/vaccinations.||
1900|091|P|   Before having surgery, tell your doctor or dentist about all||
1900|092|P|the products you use (including prescription drugs,||
1900|093|P|nonprescription drugs, and herbal products).||
1900|094|P|   During pregnancy, this medication should be used only when||
1900|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1900|096|P|   It is unknown if this drug passes into breast milk. Because of||
1900|097|P|the possible risk to the infant, breastfeeding is not recommended||
1900|098|P|while using this drug and for 4 days after taking this drug.||
1900|099|P|Consult your doctor before breastfeeding.||
1900|100|B|||
1900|101|I|DRUG INTERACTIONS:  See also How to Use section.||
1900|102|I|   Drug interactions may change how your medications work or||
1900|103|I|increase your risk for serious side effects. This document does||
1900|104|I|not contain all possible drug interactions. Keep a list of all||
1900|105|I|the products you use (including prescription/nonprescription||
1900|106|I|drugs and herbal products) and share it with your doctor and||
1900|107|I|pharmacist. Do not start, stop, or change the dosage of any||
1900|108|I|medicines without your doctor's approval.||
1900|109|B|||
1900|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1900|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1900|112|O|poison control center right away. US residents can call||
1900|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1900|114|B|||
1900|115|N|NOTES:  Do not share this medication with others unless directed||
1900|116|N|by your doctor. If this medication is used to treat||
1900|117|N|trichomoniasis, all sex partners should be treated at the same||
1900|118|N|time to avoid getting infected again.||
1900|119|B|||
1900|120|D|MISSED DOSE:  Not applicable. This medication is taken as a||
1900|121|D|single dose.||
1900|122|B|||
1900|123|R|STORAGE:  Store at room temperature away from light and moisture.||
1900|124|R|Do not store in the bathroom. Keep all medications away from||
1900|125|R|children and pets.||
1900|126|R|   Do not flush medications down the toilet or pour them into a||
1900|127|R|drain unless instructed to do so. Properly discard this product||
1900|128|R|when it is expired or no longer needed. Consult your pharmacist||
1900|129|R|or local waste disposal company.||
1900|130|B|||
1900|131|A|Information last revised May 2024.||
1900|132|A|Copyright(c) 2025 First Databank, Inc.||
1900|133|B|||
1901|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1901|002|Z|does NOT have all possible information about this product. This||
1901|003|Z|information does not assure that this product is safe, effective,||
1901|004|Z|or appropriate for you. This information is not individual||
1901|005|Z|medical advice and does not substitute for the advice of your||
1901|006|Z|health care professional. Always ask your health care||
1901|007|Z|professional for complete information about this product and your||
1901|008|Z|specific health needs.||
1901|009|B|||
1901|010|T|BUPRENORPHINE EXTENDED-RELEASE - SUBCUTANEOUS INJECTION||
1901|011|F|(BUE-pre-NOR-feen)||
1901|012|B|||
1901|013|C|COMMON BRAND NAME(S): Brixadi, Sublocade||
1901|014|B|||
1901|015|W|WARNING:  This medication must be given only by injection under||
1901|016|W|the skin. This form of buprenorphine changes from a liquid to a||
1901|017|W|more solid form upon contact with body fluids, so giving it by||
1901|018|W|injection into a vein or muscle may cause serious harm or death.||
1901|019|W|Blockage, dangerous blood clots, or local injury can happen if||
1901|020|W|this medication is not used properly.||
1901|021|W|   Ask your doctor or pharmacist if you should have medication||
1901|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
1901|023|W|Teach your family or household members about the signs of an||
1901|024|W|opioid overdose and how to treat it.||
1901|025|B|||
1901|026|U|USES:  Buprenorphine is used to treat opioid use disorder. This||
1901|027|U|long-acting form of buprenorphine should be used after starting||
1901|028|U|treatment with a single dose of a transmucosal form of||
1901|029|U|buprenorphine (one that is used under the tongue or inside the||
1901|030|U|cheek) or after being treated with buprenorphine. Buprenorphine||
1901|031|U|belongs to a class of drugs known as mixed opioid||
1901|032|U|agonist-antagonists. It helps prevent withdrawal symptoms caused||
1901|033|U|by stopping other opioids. It is used as part of a complete||
1901|034|U|treatment program for opioid use disorder (such as compliance||
1901|035|U|monitoring, counseling, behavioral contract, lifestyle changes).||
1901|036|B|||
1901|037|H|HOW TO USE:  Read the Medication Guide provided by your||
1901|038|H|pharmacist before you start using buprenorphine and each time you||
1901|039|H|get a refill. If you have any questions, ask your doctor or||
1901|040|H|pharmacist.||
1901|041|H|   This medication is given by injection under the skin by a||
1901|042|H|health care professional, as directed by your doctor. Depending||
1901|043|H|on your brand, it will be given either once monthly after the||
1901|044|H|first 2 injections, or once weekly. After the injection, this||
1901|045|H|medication changes from a liquid to a more solid form (depot).||
1901|046|H|You may see or feel a small bump under your skin at the injection||
1901|047|H|site. The bump will get smaller over time. Do not try to remove||
1901|048|H|the depot. Do not rub or massage the injection site. Try not to||
1901|049|H|let belts or clothing waistbands rub against the injection site.||
1901|050|H|   The dosage is based on your medical condition and response to||
1901|051|H|treatment.||
1901|052|H|   Use this medication regularly to get the most benefit from it.||
1901|053|H|To help you remember, mark your calendar with a reminder. If you||
1901|054|H|miss a dose, contact your doctor or pharmacist right away.||
1901|055|H|   If you suddenly stop using this medication, you may have||
1901|056|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
1901|057|H|nose, nausea, sweating, muscle aches). To help prevent||
1901|058|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
1901|059|H|more likely if you have used buprenorphine for a long time or in||
1901|060|H|high doses. Tell your doctor or pharmacist right away if you have||
1901|061|H|withdrawal.||
1901|062|B|||
1901|063|S|SIDE EFFECTS:  Nausea, vomiting, drowsiness, dizziness,||
1901|064|S|constipation, or headache may occur. Pain, itching, or redness at||
1901|065|S|the injection site may also occur. If any of these effects last||
1901|066|S|or get worse, tell your doctor or pharmacist right away.||
1901|067|S|   To prevent constipation, eat dietary fiber, drink enough||
1901|068|S|water, and exercise. You may also need to take a laxative. Ask||
1901|069|S|your pharmacist which type of laxative is right for you.||
1901|070|S|   To reduce the risk of dizziness and lightheadedness, get up||
1901|071|S|slowly when rising from a sitting or lying position.||
1901|072|S|   Remember that this medication has been prescribed because your||
1901|073|S|doctor has judged that the benefit to you is greater than the||
1901|074|S|risk of side effects. Many people using this medication do not||
1901|075|S|have serious side effects.||
1901|076|S|   Severe (possibly fatal) breathing problems can occur if this||
1901|077|S|medication is abused or used with other depressants (such as||
1901|078|S|alcohol, benzodiazepines including diazepam, other opioids).||
1901|079|S|   Tell your doctor right away if you have any serious side||
1901|080|S|effects, including: pus/blister/ulcer at injection site,||
1901|081|S|interrupted breathing during sleep (sleep apnea), mental/mood||
1901|082|S|changes (such as agitation, confusion, hallucinations),||
1901|083|S|stomach/abdominal pain, signs of your adrenal glands not working||
1901|084|S|well (such as unusual tiredness, weight loss), trouble||
1901|085|S|swallowing.||
1901|086|S|   Get medical help right away if you have any very serious side||
1901|087|S|effects, including: fainting, fast/irregular heartbeat, severe||
1901|088|S|dizziness, slow/shallow breathing, unusual drowsiness/difficulty||
1901|089|S|waking up.||
1901|090|S|   Although this medication is used to prevent withdrawal||
1901|091|S|reactions, it may rarely cause opioid withdrawal symptoms,||
1901|092|S|including diarrhea, severe mental/mood changes (such as anxiety,||
1901|093|S|irritability, trouble sleeping), muscle stiffness or shakiness.||
1901|094|S|This is more likely when you first start treatment or if you have||
1901|095|S|been using long-acting opioids such as methadone. If such||
1901|096|S|symptoms occur, tell your doctor or pharmacist right away.||
1901|097|S|   This drug may rarely cause serious (possibly fatal) liver||
1901|098|S|disease. Get medical help right away if you have any symptoms of||
1901|099|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
1901|100|S|appetite, severe stomach/abdominal pain, yellowing eyes/skin,||
1901|101|S|dark urine.||
1901|102|S|   A very serious allergic reaction to this drug is rare.||
1901|103|S|However, get medical help right away if you notice any symptoms||
1901|104|S|of a serious allergic reaction, including: rash, itching/swelling||
1901|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1901|106|S|breathing.||
1901|107|S|   This is not a complete list of possible side effects. If you||
1901|108|S|notice other effects not listed above, contact your doctor or||
1901|109|S|pharmacist.||
1901|110|S|   In the US -||
1901|111|S|   Call your doctor for medical advice about side effects. You||
1901|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1901|113|S|www.fda.gov/medwatch.||
1901|114|S|   In Canada - Call your doctor for medical advice about side||
1901|115|S|effects. You may report side effects to Health Canada at||
1901|116|S|1-866-234-2345.||
1901|117|B|||
1901|118|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1901|119|P|pharmacist if you are allergic to it; or if you have any other||
1901|120|P|allergies. This product may contain inactive ingredients (such as||
1901|121|P|latex found in the needle cap of some brands), which can cause||
1901|122|P|allergic reactions or other problems. Talk to your pharmacist for||
1901|123|P|more details.||
1901|124|P|   Before using this medication, tell your doctor or pharmacist||
1901|125|P|your medical history, especially of: brain disorders (such as||
1901|126|P|head injury, tumor, seizures), breathing problems (such as||
1901|127|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
1901|128|P|liver disease, mental/mood disorders (such as confusion,||
1901|129|P|depression), stomach/intestinal problems (such as blockage,||
1901|130|P|constipation, diarrhea due to infection, paralytic ileus),||
1901|131|P|difficulty urinating (such as due to enlarged prostate).||
1901|132|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1901|133|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1901|134|P|machinery, or do anything that needs alertness until you can do||
1901|135|P|it safely. Avoid alcoholic beverages. Alcohol also increases your||
1901|136|P|risk for breathing problems. Talk to your doctor if you are using||
1901|137|P|marijuana (cannabis).||
1901|138|P|   Buprenorphine may cause a condition that affects the heart||
1901|139|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1901|140|P|serious (rarely fatal) fast/irregular heartbeat and other||
1901|141|P|symptoms (such as severe dizziness, fainting) that need medical||
1901|142|P|attention right away.||
1901|143|P|   The risk of QT prolongation may be increased if you have||
1901|144|P|certain medical conditions or are taking other drugs that may||
1901|145|P|cause QT prolongation. Before using buprenorphine, tell your||
1901|146|P|doctor or pharmacist of all the drugs you take and if you have||
1901|147|P|any of the following conditions: certain heart problems (heart||
1901|148|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1901|149|P|history of certain heart problems (QT prolongation in the EKG,||
1901|150|P|sudden cardiac death).||
1901|151|P|   Low levels of potassium or magnesium in the blood may also||
1901|152|P|increase your risk of QT prolongation. This risk may increase if||
1901|153|P|you use certain drugs (such as diuretics/"water pills") or if you||
1901|154|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1901|155|P|Talk to your doctor about using buprenorphine safely.||
1901|156|P|   Tell all of your doctors that you use this medication and have||
1901|157|P|regularly used opioids, especially in cases of emergency||
1901|158|P|treatment.||
1901|159|P|   Before having surgery, tell your doctor or dentist about all||
1901|160|P|the products you use (including prescription drugs,||
1901|161|P|nonprescription drugs, and herbal products).||
1901|162|P|   Older adults may be more sensitive to the side effects of this||
1901|163|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
1901|164|P|breathing, and QT prolongation (see above).||
1901|165|P|   Before using this medication, women of childbearing age should||
1901|166|P|talk with their doctor(s) about the risks and benefits. Tell your||
1901|167|P|doctor if you are pregnant or plan to become pregnant. During||
1901|168|P|pregnancy, this medication should be used only when clearly||
1901|169|P|needed. It may slightly increase the risk of birth defects if||
1901|170|P|used during the first two months of pregnancy. Also, using it for||
1901|171|P|a long time or in high doses near the expected delivery date may||
1901|172|P|harm the unborn baby. To lessen the risk, use the smallest||
1901|173|P|effective dose for the shortest possible time. Tell the doctor||
1901|174|P|right away if you notice any symptoms in your newborn baby such||
1901|175|P|as slow/shallow breathing, irritability, crying that is unusual||
1901|176|P|or does not stop, vomiting, or diarrhea.||
1901|177|P|   This drug passes into breast milk and may rarely have||
1901|178|P|undesirable effects on a nursing infant. Tell the doctor right||
1901|179|P|away if your baby develops unusual sleepiness, difficulty||
1901|180|P|feeding, or trouble breathing. Consult your doctor before||
1901|181|P|breastfeeding.||
1901|182|B|||
1901|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1901|184|I|medications work or increase your risk for serious side effects.||
1901|185|I|This document does not contain all possible drug interactions.||
1901|186|I|Keep a list of all the products you use (including||
1901|187|I|prescription/nonprescription drugs and herbal products) and share||
1901|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
1901|189|I|the dosage of any medicines without your doctor's approval.||
1901|190|I|   Some products that may interact with this drug are: certain||
1901|191|I|pain medications (mixed opioid agonist-antagonists such as||
1901|192|I|butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.||
1901|193|I|   The risk of serious side effects (such as slow/shallow||
1901|194|I|breathing, severe drowsiness/dizziness) may be increased if this||
1901|195|I|medication is used with other products that may also cause||
1901|196|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1901|197|I|if you are taking other products such as other opioid pain or||
1901|198|I|cough relievers (such as codeine, hydrocodone), alcohol,||
1901|199|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
1901|200|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
1901|201|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
1901|202|I|cetirizine, diphenhydramine).||
1901|203|I|   Check the labels on all your medicines (such as allergy or||
1901|204|I|cough-and-cold products) because they may contain ingredients||
1901|205|I|that cause drowsiness. Ask your pharmacist about using those||
1901|206|I|products safely.||
1901|207|B|||
1901|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1901|209|O|as passing out or trouble breathing, give them naloxone or||
1901|210|O|nalmefene if available, then call 911. If the person is awake and||
1901|211|O|has no symptoms, call a poison control center right away. US||
1901|212|O|residents can call 1-800-222-1222. Canada residents can call||
1901|213|O|1-844-764-7669. Symptoms of overdose may include: slow breathing,||
1901|214|O|slow heartbeat, loss of consciousness.||
1901|215|B|||
1901|216|N|NOTES:  Do not share this medication with others. Sharing it is||
1901|217|N|against the law.||
1901|218|N|   Lab and/or medical tests (such as liver function) should be||
1901|219|N|done while you are using this medication. Keep all medical and||
1901|220|N|lab appointments.||
1901|221|B|||
1901|222|D|MISSED DOSE:  It is important to get each dose of this medication||
1901|223|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1901|224|D|right away for a new dosing schedule.||
1901|225|B|||
1901|226|R|STORAGE:  Not applicable. This medication is given in a hospital||
1901|227|R|or clinic or doctor's office and will not be stored at home.||
1901|228|B|||
1901|229|A|Information last revised August 2025.||
1901|230|A|Copyright(c) 2025 First Databank, Inc.||
1901|231|B|||
1902|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1902|002|Z|does NOT have all possible information about this product. This||
1902|003|Z|information does not assure that this product is safe, effective,||
1902|004|Z|or appropriate for you. This information is not individual||
1902|005|Z|medical advice and does not substitute for the advice of your||
1902|006|Z|health care professional. Always ask your health care||
1902|007|Z|professional for complete information about this product and your||
1902|008|Z|specific health needs.||
1902|009|B|||
1902|010|T|OZENOXACIN - TOPICAL||
1902|011|F|(OH-zen-OX-a-sin)||
1902|012|B|||
1902|013|C|COMMON BRAND NAME(S): Xepi||
1902|014|B|||
1902|015|U|USES:  Ozenoxacin is used to treat a certain skin infection||
1902|016|U|(impetigo). This medication belongs to a class of drugs known as||
1902|017|U|quinolone antibiotics. It works by stopping the growth of certain||
1902|018|U|bacteria.||
1902|019|B|||
1902|020|H|HOW TO USE:  Use this medication only on the skin. Clean and dry||
1902|021|H|the affected area first. Then apply a thin layer of cream to the||
1902|022|H|affected area as directed by your doctor, usually twice a day.||
1902|023|H|You may cover the treated area with a bandage or gauze.||
1902|024|H|   Wash your hands after applying the medication unless you are||
1902|025|H|treating an area on your hands. Avoid using this medication||
1902|026|H|around your eyes, nose, mouth, or inside the vagina. If the||
1902|027|H|medication gets in these areas, wipe off the cream and rinse well||
1902|028|H|with plenty of water. Do not use on large areas of skin unless||
1902|029|H|otherwise directed by your doctor.||
1902|030|H|   Use this medication regularly to get the most benefit from it.||
1902|031|H|Continue to use it for the full time prescribed, even if symptoms||
1902|032|H|disappear after a few days. Stopping the medication too early may||
1902|033|H|result in a return of the infection.||
1902|034|H|   Tell your doctor if your condition does not get better in 3||
1902|035|H|days.||
1902|036|B|||
1902|037|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1902|038|S|because your doctor has judged that the benefit to you is greater||
1902|039|S|than the risk of side effects. Many people using this medication||
1902|040|S|do not have serious side effects.||
1902|041|S|   Use of this medication for prolonged or repeated periods may||
1902|042|S|result in a new skin infection caused by fungus or yeast or other||
1902|043|S|bacteria. Tell your doctor right away if you notice signs of a||
1902|044|S|new infection, or if your current infection does not get better||
1902|045|S|or if it gets worse.||
1902|046|S|   A very serious allergic reaction to this drug is rare.||
1902|047|S|However, get medical help right away if you notice any symptoms||
1902|048|S|of a serious allergic reaction, including: rash, itching/swelling||
1902|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1902|050|S|breathing.||
1902|051|S|   This is not a complete list of possible side effects. If you||
1902|052|S|notice other effects not listed above, contact your doctor or||
1902|053|S|pharmacist.||
1902|054|S|   In the US -||
1902|055|S|   Call your doctor for medical advice about side effects. You||
1902|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1902|057|S|www.fda.gov/medwatch.||
1902|058|S|   In Canada - Call your doctor for medical advice about side||
1902|059|S|effects. You may report side effects to Health Canada at||
1902|060|S|1-866-234-2345.||
1902|061|B|||
1902|062|P|PRECAUTIONS:  Before using ozenoxacin, tell your doctor or||
1902|063|P|pharmacist if you are allergic to it; or if you have any other||
1902|064|P|allergies. This product may contain inactive ingredients, which||
1902|065|P|can cause allergic reactions or other problems. Talk to your||
1902|066|P|pharmacist for more details.||
1902|067|P|   Before using this medication, tell your doctor or pharmacist||
1902|068|P|your medical history.||
1902|069|P|   Before having surgery, tell your doctor or dentist about all||
1902|070|P|the products you use (including prescription drugs,||
1902|071|P|nonprescription drugs, and herbal products).||
1902|072|P|   During pregnancy, this medication should be used only when||
1902|073|P|clearly needed. Discuss the risks and benefits with your doctor.||
1902|074|P|   It is unknown if this drug passes into breast milk. Consult||
1902|075|P|your doctor before breastfeeding.||
1902|076|B|||
1902|077|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1902|078|I|medications work or increase your risk for serious side effects.||
1902|079|I|This document does not contain all possible drug interactions.||
1902|080|I|Keep a list of all the products you use (including||
1902|081|I|prescription/nonprescription drugs and herbal products) and share||
1902|082|I|it with your doctor and pharmacist. Do not start, stop, or change||
1902|083|I|the dosage of any medicines without your doctor's approval.||
1902|084|B|||
1902|085|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1902|086|O|has overdosed and has serious symptoms such as passing out or||
1902|087|O|trouble breathing, call 911. Otherwise, call a poison control||
1902|088|O|center right away. US residents can call 1-800-222-1222. Canada||
1902|089|O|residents can call 1-844-764-7669.||
1902|090|B|||
1902|091|N|NOTES:  Do not share this medication with others.||
1902|092|N|   This medication has been prescribed for your current condition||
1902|093|N|only. Do not use it later for another infection unless your||
1902|094|N|doctor tells you to.||
1902|095|B|||
1902|096|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1902|097|D|If it is near the time of the next dose, skip the missed dose.||
1902|098|D|Use your next dose at the regular time. Do not double the dose to||
1902|099|D|catch up.||
1902|100|B|||
1902|101|R|STORAGE:  Different brands of this medication have different||
1902|102|R|storage needs. Check the product package for instructions on how||
1902|103|R|to store your brand, or ask your pharmacist. Keep all medications||
1902|104|R|away from children and pets.||
1902|105|R|   Do not flush medications down the toilet or pour them into a||
1902|106|R|drain unless instructed to do so. Properly discard this product||
1902|107|R|when it is expired or no longer needed. Consult your pharmacist||
1902|108|R|or local waste disposal company.||
1902|109|B|||
1902|110|A|Information last revised May 2024.||
1902|111|A|Copyright(c) 2025 First Databank, Inc.||
1902|112|B|||
1903|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1903|002|Z|does NOT have all possible information about this product. This||
1903|003|Z|information does not assure that this product is safe, effective,||
1903|004|Z|or appropriate for you. This information is not individual||
1903|005|Z|medical advice and does not substitute for the advice of your||
1903|006|Z|health care professional. Always ask your health care||
1903|007|Z|professional for complete information about this product and your||
1903|008|Z|specific health needs.||
1903|009|B|||
1903|010|T|PREGABALIN EXTENDED-RELEASE - ORAL||
1903|011|F|(pree-GAB-a-lin)||
1903|012|B|||
1903|013|C|COMMON BRAND NAME(S): Lyrica CR||
1903|014|B|||
1903|015|U|USES:  This medication is used to treat pain caused by nerve||
1903|016|U|damage due to diabetes or shingles (herpes zoster) infection.||
1903|017|B|||
1903|018|H|HOW TO USE:  Read the Medication Guide provided by your||
1903|019|H|pharmacist before you start taking pregabalin and each time you||
1903|020|H|get a refill. If you have any questions, ask your doctor or||
1903|021|H|pharmacist.||
1903|022|H|   Take this medication by mouth as directed by your doctor,||
1903|023|H|usually once daily after an evening meal. Swallow the tablets||
1903|024|H|whole. Do not split, crush, or chew. Doing so can release all of||
1903|025|H|the drug at once, increasing the risk of side effects.||
1903|026|H|   The dosage is based on your medical condition and response to||
1903|027|H|treatment. To reduce your risk of side effects (such as dizziness||
1903|028|H|and drowsiness), your doctor may direct you to start this||
1903|029|H|medication at a low dose and gradually increase your dose. Follow||
1903|030|H|your doctor's instructions carefully.||
1903|031|H|   Use this medication regularly to get the most benefit from it.||
1903|032|H|To help you remember, take it at the same time each day.||
1903|033|H|   Do not stop taking this medication without consulting your||
1903|034|H|doctor. Some conditions may become worse when this drug is||
1903|035|H|suddenly stopped. Also, you may experience symptoms such as||
1903|036|H|difficulty sleeping, nausea, headache, and diarrhea. To prevent||
1903|037|H|these symptoms while you are stopping treatment with this drug,||
1903|038|H|your doctor may reduce your dose gradually. Report any new or||
1903|039|H|worsening symptoms right away.||
1903|040|H|   Though it helps many people, this medication may sometimes||
1903|041|H|cause addiction. This risk may be higher if you have a substance||
1903|042|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1903|043|H|Take this medication exactly as prescribed to lower the risk of||
1903|044|H|addiction. Ask your doctor or pharmacist for more details.||
1903|045|H|   Tell your doctor if your condition lasts or gets worse.||
1903|046|B|||
1903|047|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, dry mouth,||
1903|048|S|nausea, constipation, and weight gain may occur. If any of these||
1903|049|S|effects last or get worse, tell your doctor or pharmacist||
1903|050|S|promptly.||
1903|051|S|   Remember that this medication has been prescribed because your||
1903|052|S|doctor has judged that the benefit to you is greater than the||
1903|053|S|risk of side effects. Many people using this medication do not||
1903|054|S|have serious side effects.||
1903|055|S|   Tell your doctor right away if you have any serious side||
1903|056|S|effects, including: vision changes (such as blurred vision),||
1903|057|S|unusual bleeding/bruising, muscle pain/tenderness/weakness||
1903|058|S|(especially with fever or unusual tiredness), swelling||
1903|059|S|hands/ankles/feet.||
1903|060|S|   A small number of people who take anticonvulsants for any||
1903|061|S|condition (such as seizure, bipolar disorder, pain) may||
1903|062|S|experience depression, suicidal thoughts/attempts, or other||
1903|063|S|mental/mood problems. These effects may occur even after the||
1903|064|S|medication has been stopped. Tell your doctor right away if you||
1903|065|S|or your family/caregiver notice any unusual/sudden changes in||
1903|066|S|your mood, thoughts, or behavior such as signs of depression,||
1903|067|S|suicidal thoughts/attempts, thoughts about harming yourself.||
1903|068|S|   Get medical help right away if you have any very serious side||
1903|069|S|effects, including: slow/shallow breathing.||
1903|070|S|   A very serious allergic reaction to this drug is rare.||
1903|071|S|However, get medical help right away if you notice any symptoms||
1903|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1903|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1903|074|S|breathing.||
1903|075|S|   This is not a complete list of possible side effects. If you||
1903|076|S|notice other effects not listed above, contact your doctor or||
1903|077|S|pharmacist.||
1903|078|S|   In the US -||
1903|079|S|   Call your doctor for medical advice about side effects. You||
1903|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1903|081|S|www.fda.gov/medwatch.||
1903|082|S|   In Canada - Call your doctor for medical advice about side||
1903|083|S|effects. You may report side effects to Health Canada at||
1903|084|S|1-866-234-2345.||
1903|085|B|||
1903|086|P|PRECAUTIONS:  Before taking pregabalin, tell your doctor or||
1903|087|P|pharmacist if you are allergic to it; or if you have any other||
1903|088|P|allergies. This product may contain inactive ingredients, which||
1903|089|P|can cause allergic reactions or other problems. Talk to your||
1903|090|P|pharmacist for more details.||
1903|091|P|   Before using this medication, tell your doctor or pharmacist||
1903|092|P|your medical history, especially of: heart problems (such as||
1903|093|P|heart failure), kidney disease, history of an allergic reaction||
1903|094|P|which included itching/swelling of the face/lips/tongue/throat||
1903|095|P|(angioedema), personal or family history of a substance use||
1903|096|P|disorder (such as overuse of or addiction to drugs/alcohol),||
1903|097|P|breathing problems (such as COPD).||
1903|098|P|   This drug may make you dizzy or drowsy or cause blurred||
1903|099|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
1903|100|P|or drowsy. Do not drive, use machinery, or do anything that needs||
1903|101|P|alertness or clear vision until you can do it safely. Avoid||
1903|102|P|alcoholic beverages. Talk to your doctor if you are using||
1903|103|P|marijuana (cannabis).||
1903|104|P|   Before having surgery, tell your doctor or dentist about all||
1903|105|P|the products you use (including prescription drugs,||
1903|106|P|nonprescription drugs, and herbal products).||
1903|107|P|   Older adults may be more sensitive to the side effects of this||
1903|108|P|drug, especially slow/shallow breathing.||
1903|109|P|   During pregnancy, this medication should be used only when||
1903|110|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1903|111|P|benefits with your doctor.||
1903|112|P|   This drug passes into breast milk. Consult your doctor before||
1903|113|P|breastfeeding.||
1903|114|B|||
1903|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1903|116|I|medications work or increase your risk for serious side effects.||
1903|117|I|This document does not contain all possible drug interactions.||
1903|118|I|Keep a list of all the products you use (including||
1903|119|I|prescription/nonprescription drugs and herbal products) and share||
1903|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1903|121|I|the dosage of any medicines without your doctor's approval.||
1903|122|I|   A product that may interact with this drug is: orlistat.||
1903|123|I|   The risk of serious side effects (such as slow/shallow||
1903|124|I|breathing, severe drowsiness/dizziness) may be increased if this||
1903|125|I|medication is taken with other products that may also cause||
1903|126|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1903|127|I|if you are using other products such as opioid pain or cough||
1903|128|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1903|129|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1903|130|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1903|131|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1903|132|I|diphenhydramine).||
1903|133|I|   Check the labels on all your medicines (such as allergy or||
1903|134|I|cough-and-cold products) because they may contain ingredients||
1903|135|I|that cause drowsiness. Ask your pharmacist about using those||
1903|136|I|products safely.||
1903|137|B|||
1903|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1903|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1903|140|O|poison control center right away. US residents can call||
1903|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1903|142|B|||
1903|143|N|NOTES:  Do not share this medication with others. Sharing it is||
1903|144|N|against the law.||
1903|145|N|   Lab and/or medical tests (such as kidney function, platelet||
1903|146|N|count) may be done while you are taking this medication. Keep all||
1903|147|N|medical and lab appointments. Consult your doctor for more||
1903|148|N|details.||
1903|149|B|||
1903|150|D|MISSED DOSE:  If you miss a dose and remember before bedtime,||
1903|151|D|take it after a snack before bedtime. If it is the next morning||
1903|152|D|when you remember, take the dose after the morning meal. If you||
1903|153|D|remember after the morning, skip the missed dose. Take your next||
1903|154|D|dose at the regular time. Do not double the dose to catch up.||
1903|155|B|||
1903|156|R|STORAGE:  Store at room temperature away from light and moisture.||
1903|157|R|Do not store in the bathroom. Keep all medications away from||
1903|158|R|children and pets.||
1903|159|R|   Do not flush medications down the toilet or pour them into a||
1903|160|R|drain unless instructed to do so. Properly discard this product||
1903|161|R|when it is expired or no longer needed. Consult your pharmacist||
1903|162|R|or local waste disposal company.||
1903|163|B|||
1903|164|A|Information last revised May 2025.||
1903|165|A|Copyright(c) 2025 First Databank, Inc.||
1903|166|B|||
1904|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1904|002|Z|does NOT have all possible information about this product. This||
1904|003|Z|information does not assure that this product is safe, effective,||
1904|004|Z|or appropriate for you. This information is not individual||
1904|005|Z|medical advice and does not substitute for the advice of your||
1904|006|Z|health care professional. Always ask your health care||
1904|007|Z|professional for complete information about this product and your||
1904|008|Z|specific health needs.||
1904|009|B|||
1904|010|T|ERTUGLIFLOZIN - ORAL||
1904|011|F|(ER-too-gli-FLOE-zin)||
1904|012|B|||
1904|013|C|COMMON BRAND NAME(S): Steglatro||
1904|014|B|||
1904|015|U|USES:  Ertugliflozin is used with a proper diet and exercise||
1904|016|U|program to control high blood sugar in people with type 2||
1904|017|U|diabetes. Controlling high blood sugar helps prevent kidney||
1904|018|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1904|019|U|function problems. Proper control of diabetes may also lessen||
1904|020|U|your risk of a heart attack or stroke. Ertugliflozin works by||
1904|021|U|increasing the removal of sugar by your kidneys.||
1904|022|B|||
1904|023|H|HOW TO USE:  Read the Medication Guide provided by your||
1904|024|H|pharmacist before you start taking ertugliflozin and each time||
1904|025|H|you get a refill. If you have any questions, ask your doctor or||
1904|026|H|pharmacist.||
1904|027|H|   Take this medication by mouth with or without food as directed||
1904|028|H|by your doctor, usually once daily in the morning. The dosage is||
1904|029|H|based on your medical condition and response to treatment.||
1904|030|H|   Use this medication regularly to get the most benefit from it.||
1904|031|H|To help you remember, take it at the same time each day.||
1904|032|H|   Tell your doctor if your condition does not get better or if||
1904|033|H|it gets worse (your blood sugar is too high or too low).||
1904|034|B|||
1904|035|S|SIDE EFFECTS:  Frequent urination, dizziness, or lightheadedness||
1904|036|S|may occur. If any of these effects last or get worse, tell your||
1904|037|S|doctor or pharmacist promptly.||
1904|038|S|   To reduce the risk of dizziness and lightheadedness, get up||
1904|039|S|slowly when rising from a sitting or lying position.||
1904|040|S|   Remember that this medication has been prescribed because your||
1904|041|S|doctor has judged that the benefit to you is greater than the||
1904|042|S|risk of side effects. Many people using this medication do not||
1904|043|S|have serious side effects.||
1904|044|S|   Tell your doctor right away if you have any serious side||
1904|045|S|effects, including: signs of a urinary tract infection (such as||
1904|046|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1904|047|S|signs of kidney problems (such as change in the amount of urine,||
1904|048|S|swelling legs/feet).||
1904|049|S|   Get medical help right away if you have any very serious side||
1904|050|S|effects, including: unusual tiredness, nausea/vomiting,||
1904|051|S|stomach/abdominal pain, trouble breathing.||
1904|052|S|   This medication may cause a new yeast infection in the vagina||
1904|053|S|or the penis. It may also cause a rare but very serious bacterial||
1904|054|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1904|055|S|your doctor right away if you have signs of a yeast infection in||
1904|056|S|the vagina (such as unusual vaginal||
1904|057|S|discharge/burning/itching/odor) or in the penis (such as||
1904|058|S|redness/itching/swelling of the penis, unusual discharge from the||
1904|059|S|penis). However, get medical help right away if you have any||
1904|060|S|pain/redness/swelling in or around the genital/anal area, along||
1904|061|S|with a fever or feeling unwell.||
1904|062|S|   This medication may increase the risk of lower limb amputation||
1904|063|S|(especially of the toe and foot). The risk is higher if you have||
1904|064|S|poor blood flow in the legs, nerve problems, foot ulcers, or have||
1904|065|S|had a previous amputation. To lessen the risk, check your feet||
1904|066|S|regularly and tell your doctor if you have new pain, tenderness,||
1904|067|S|sores, or ulcers on your legs or feet.||
1904|068|S|   Ertugliflozin does not usually cause low blood sugar||
1904|069|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1904|070|S|prescribed with other diabetes medications, or if you do not get||
1904|071|S|enough calories from food, or if you do unusually heavy exercise.||
1904|072|S|Talk with your doctor or pharmacist about whether the dose of||
1904|073|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1904|074|S|of low blood sugar include sudden sweating, shaking, fast||
1904|075|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1904|076|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1904|077|S|treat low blood sugar. If you don't have these reliable forms of||
1904|078|S|glucose, rapidly raise your blood sugar by eating a quick source||
1904|079|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1904|080|S|juice or non-diet soda. Tell your doctor right away about the||
1904|081|S|reaction and the use of this product. To help prevent low blood||
1904|082|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1904|083|S|Check with your doctor or pharmacist to find out what you should||
1904|084|S|do if you miss a meal.||
1904|085|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1904|086|S|thirst/urination. If these symptoms occur, tell your doctor right||
1904|087|S|away. Your doctor may need to adjust your diabetes medication,||
1904|088|S|exercise program, or diet.||
1904|089|S|   This medication may cause you to become dehydrated. This can||
1904|090|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1904|091|S|dehydration. Tell your doctor or pharmacist right away if you are||
1904|092|S|not able to drink fluids as usual, or losing fluid (such as due||
1904|093|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1904|094|S|right away if you have any signs of dehydration, such as||
1904|095|S|urinating less than usual, unusual dry mouth/thirst, fast||
1904|096|S|heartbeat, or dizziness/lightheadedness/fainting.||
1904|097|S|   A very serious allergic reaction to this drug is rare.||
1904|098|S|However, get medical help right away if you notice any symptoms||
1904|099|S|of a serious allergic reaction, including: rash, itching/swelling||
1904|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1904|101|S|breathing.||
1904|102|S|   This is not a complete list of possible side effects. If you||
1904|103|S|notice other effects not listed above, contact your doctor or||
1904|104|S|pharmacist.||
1904|105|S|   In the US -||
1904|106|S|   Call your doctor for medical advice about side effects. You||
1904|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1904|108|S|www.fda.gov/medwatch.||
1904|109|S|   In Canada - Call your doctor for medical advice about side||
1904|110|S|effects. You may report side effects to Health Canada at||
1904|111|S|1-866-234-2345.||
1904|112|B|||
1904|113|P|PRECAUTIONS:  Before taking ertugliflozin, tell your doctor or||
1904|114|P|pharmacist if you are allergic to it; or if you have any other||
1904|115|P|allergies. This product may contain inactive ingredients, which||
1904|116|P|can cause allergic reactions or other problems. Talk to your||
1904|117|P|pharmacist for more details.||
1904|118|P|   Before using this medication, tell your doctor or pharmacist||
1904|119|P|your medical history, especially of: kidney disease, disease of||
1904|120|P|the pancreas (pancreatitis), dehydration, use/abuse of alcohol,||
1904|121|P|low blood pressure, history of yeast infections in the vagina or||
1904|122|P|penis, blocked or narrowed blood vessels, usually in the leg,||
1904|123|P|nerve problems (such as diabetic peripheral neuropathy), foot||
1904|124|P|sores or ulcers, amputation.||
1904|125|P|   You may experience blurred vision, dizziness, or drowsiness||
1904|126|P|due to extremely low or high blood sugar. Do not drive, use||
1904|127|P|machinery, or do anything that needs alertness until you can do||
1904|128|P|it safely.||
1904|129|P|   Limit alcohol while taking this medication because it can||
1904|130|P|increase your risk of developing low blood sugar and a high||
1904|131|P|ketone level.||
1904|132|P|   It may be harder to control your blood sugar when your body is||
1904|133|P|stressed (such as due to fever, infection, injury, or surgery).||
1904|134|P|Also, if you are eating less or not able to eat due to these||
1904|135|P|conditions or any illness, this can lead to a high ketone level||
1904|136|P|while you are taking this medication. Consult your doctor because||
1904|137|P|this may require a change in your treatment plan, medications, or||
1904|138|P|blood sugar or ketone testing.||
1904|139|P|   Before having surgery, tell your doctor or dentist about all||
1904|140|P|the products you use (including prescription drugs,||
1904|141|P|nonprescription drugs, and herbal products).||
1904|142|P|   Older adults may be more sensitive to the side effects of this||
1904|143|P|drug, especially dizziness/fainting (usually when standing),||
1904|144|P|dehydration, and kidney disease.||
1904|145|P|   During pregnancy, this medication should be used only when||
1904|146|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1904|147|P|benefits with your doctor.||
1904|148|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1904|149|P|your doctor for managing your blood sugar while pregnant. Your||
1904|150|P|doctor may change your diabetes treatment during your pregnancy||
1904|151|P|(such as diet and medications including insulin).||
1904|152|P|   It is unknown if this drug passes into breast milk. Consult||
1904|153|P|your doctor before breastfeeding.||
1904|154|B|||
1904|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1904|156|I|medications work or increase your risk for serious side effects.||
1904|157|I|This document does not contain all possible drug interactions.||
1904|158|I|Keep a list of all the products you use (including||
1904|159|I|prescription/nonprescription drugs and herbal products) and share||
1904|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
1904|161|I|the dosage of any medicines without your doctor's approval.||
1904|162|I|   Beta blocker medications (such as metoprolol, propranolol,||
1904|163|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1904|164|I|heartbeat you would usually feel when your blood sugar falls too||
1904|165|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1904|166|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1904|167|I|   Many drugs can affect your blood sugar, making it harder to||
1904|168|I|control. Before you start, stop, or change any medication, talk||
1904|169|I|with your doctor or pharmacist about how the medication may||
1904|170|I|affect your blood sugar. Check your blood sugar regularly as||
1904|171|I|directed and share the results with your doctor. Tell your doctor||
1904|172|I|right away if you have symptoms of high or low blood sugar. (See||
1904|173|I|also Side Effects section.) Your doctor may need to adjust your||
1904|174|I|diabetes medication, exercise program, or diet.||
1904|175|I|   Your urine will test positive for glucose. Make sure lab||
1904|176|I|personnel and all your doctors know you use this drug.||
1904|177|B|||
1904|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1904|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1904|180|O|poison control center right away. US residents can call||
1904|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1904|182|B|||
1904|183|N|NOTES:  Do not share this medication with others.||
1904|184|N|   Attend a diabetes education program to learn more about how to||
1904|185|N|manage your diabetes with medications, diet, exercise, foot care,||
1904|186|N|and regular medical exams.||
1904|187|N|   Learn the symptoms of high and low blood sugar and how to||
1904|188|N|treat low blood sugar. Check your blood sugar regularly as||
1904|189|N|directed.||
1904|190|N|   Lab and/or medical tests (such as kidney function, liver||
1904|191|N|function, blood sugar, hemoglobin A1c, cholesterol, ketones)||
1904|192|N|should be done before you start taking this medication and while||
1904|193|N|you are taking it. Keep all medical and lab appointments. Consult||
1904|194|N|your doctor for more details.||
1904|195|B|||
1904|196|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1904|197|D|remember. If it is near the time of the next dose, skip the||
1904|198|D|missed dose. Take your next dose at the regular time. Do not||
1904|199|D|double the dose to catch up.||
1904|200|B|||
1904|201|R|STORAGE:  Store at room temperature away from light and moisture.||
1904|202|R|Do not store in the bathroom. Keep all medications away from||
1904|203|R|children and pets.||
1904|204|R|   Do not flush medications down the toilet or pour them into a||
1904|205|R|drain unless instructed to do so. Properly discard this product||
1904|206|R|when it is expired or no longer needed. Consult your pharmacist||
1904|207|R|or local waste disposal company.||
1904|208|B|||
1904|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
1904|210|M|medical emergency. For information about enrolling in MedicAlert,||
1904|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1904|212|B|||
1904|213|A|Information last revised May 2025.||
1904|214|A|Copyright(c) 2025 First Databank, Inc.||
1904|215|B|||
1905|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1905|002|Z|does NOT have all possible information about this product. This||
1905|003|Z|information does not assure that this product is safe, effective,||
1905|004|Z|or appropriate for you. This information is not individual||
1905|005|Z|medical advice and does not substitute for the advice of your||
1905|006|Z|health care professional. Always ask your health care||
1905|007|Z|professional for complete information about this product and your||
1905|008|Z|specific health needs.||
1905|009|B|||
1905|010|T|VORETIGENE NEPARVOVEC - INTRAOCULAR||
1905|011|F|(voe-RET-i-jeen ne-PAR-voe-vek)||
1905|012|B|||
1905|013|C|COMMON BRAND NAME(S): Luxturna||
1905|014|B|||
1905|015|U|USES:  This medication is used to treat a certain inherited eye||
1905|016|U|condition (retinal dystrophy). Voretigene neparvovec is made from||
1905|017|U|a certain virus that has been specially prepared. The virus is||
1905|018|U|used to carry a certain human gene (RPE65) into cells. You will||
1905|019|U|receive this treatment only after tests by your doctor have found||
1905|020|U|that this gene does not work the way it should in your cells.||
1905|021|U|This type of treatment is known as gene therapy. Treatment may||
1905|022|U|improve symptoms of retinal dystrophy, such as decreased vision,||
1905|023|U|loss of side vision, or poor vision at night.||
1905|024|B|||
1905|025|H|HOW TO USE:  Your doctor may prescribe medication (such as||
1905|026|H|prednisone) for you to take by mouth daily, starting 3 days||
1905|027|H|before treatment to each eye, and continuing for 2 weeks after||
1905|028|H|the injections. Carefully follow your doctor's directions for||
1905|029|H|taking your medication(s).||
1905|030|H|   This medication is prepared and given by injection into the||
1905|031|H|affected eye(s) by a health care professional. Your doctor will||
1905|032|H|treat each eye on separate days, at least 6 days apart. The eye||
1905|033|H|is numbed before the injection. After the injection, you will||
1905|034|H|remain in the doctor's office for a while, and your eye(s) and||
1905|035|H|vision will be monitored.||
1905|036|H|   After leaving the hospital or clinic, try to rest lying down||
1905|037|H|as much as possible for 24 hours.||
1905|038|H|   During your procedure, an air bubble will form in your eye.||
1905|039|H|This will slowly shrink over 1 week or longer. Do not fly in an||
1905|040|H|airplane, travel to high altitudes, or scuba dive until you are||
1905|041|H|told the air bubble is gone. A change in altitude while the air||
1905|042|H|bubble is in your eye may cause permanent vision loss.||
1905|043|H|   Small amounts of virus may shed from your tears and nose for a||
1905|044|H|short time after the injection. Ask your doctor how to handle and||
1905|045|H|dispose of waste material from dressings, tears, and your nose||
1905|046|H|for up to 7 days after the injection.||
1905|047|H|   Tell your doctor if your condition does not get better or if||
1905|048|H|it gets worse.||
1905|049|B|||
1905|050|S|SIDE EFFECTS:  Mild discomfort or increased tears may occur. If||
1905|051|S|either of these effects lasts or gets worse, tell your doctor or||
1905|052|S|pharmacist promptly.||
1905|053|S|   Remember that this medication has been prescribed because your||
1905|054|S|doctor has judged that the benefit to you is greater than the||
1905|055|S|risk of side effects. Many people using this medication do not||
1905|056|S|have serious side effects.||
1905|057|S|   This medication may rarely increase your risk for developing||
1905|058|S|certain serious eye conditions (such as cataracts,||
1905|059|S|endophthalmitis, retinal tear/detachment). Tell your doctor right||
1905|060|S|away if you notice any of these symptoms in the affected eye(s):||
1905|061|S|pain, vision changes (such as decreased vision, blurred vision,||
1905|062|S|flashes of light, seeing new floaters).||
1905|063|S|   A very serious allergic reaction to this drug is rare.||
1905|064|S|However, get medical help right away if you notice any symptoms||
1905|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1905|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1905|067|S|breathing.||
1905|068|S|   This is not a complete list of possible side effects. If you||
1905|069|S|notice other effects not listed above, contact your doctor or||
1905|070|S|pharmacist.||
1905|071|S|   In the US -||
1905|072|S|   Call your doctor for medical advice about side effects. You||
1905|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1905|074|S|www.fda.gov/medwatch.||
1905|075|S|   In Canada - Call your doctor for medical advice about side||
1905|076|S|effects. You may report side effects to Health Canada at||
1905|077|S|1-866-234-2345.||
1905|078|B|||
1905|079|P|PRECAUTIONS:  See also How to Use section.||
1905|080|P|   Before receiving this medication, tell your doctor or||
1905|081|P|pharmacist if you are allergic to it; or if you have any other||
1905|082|P|allergies. This product may contain inactive ingredients, which||
1905|083|P|can cause allergic reactions or other problems. Talk to your||
1905|084|P|pharmacist for more details.||
1905|085|P|   Before using this medication, tell your doctor or pharmacist||
1905|086|P|your medical history, especially of: other eye conditions (such||
1905|087|P|as cataracts, glaucoma).||
1905|088|P|   This drug may cause blurred vision. Do not drive, use||
1905|089|P|machinery, or do anything that needs clear vision until you can||
1905|090|P|do it safely.||
1905|091|P|   Do not fly in an airplane, travel to high altitudes, or scuba||
1905|092|P|dive until your doctor says you may do so.||
1905|093|P|   Before having surgery, tell your doctor or dentist about all||
1905|094|P|the products you use (including prescription drugs,||
1905|095|P|nonprescription drugs, and herbal products).||
1905|096|P|   During pregnancy, this medication should be used only when||
1905|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
1905|098|P|   It is unknown if this medication passes into breast milk.||
1905|099|P|Consult your doctor before breastfeeding.||
1905|100|B|||
1905|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1905|102|I|medications work or increase your risk for serious side effects.||
1905|103|I|This document does not contain all possible drug interactions.||
1905|104|I|Keep a list of all the products you use (including||
1905|105|I|prescription/nonprescription drugs and herbal products) and share||
1905|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
1905|107|I|the dosage of any medicines without your doctor's approval.||
1905|108|B|||
1905|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1905|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1905|111|O|poison control center right away. US residents can call||
1905|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1905|113|B|||
1905|114|N|NOTES:  Medical tests (such as eye exams) should be done while||
1905|115|N|you are using this medication. Keep all medical appointments.||
1905|116|N|Consult your doctor for more details.||
1905|117|B|||
1905|118|D|MISSED DOSE:  It is important to get each dose of this medication||
1905|119|D|as scheduled. If you miss a dose, ask your doctor right away for||
1905|120|D|a new dosing schedule.||
1905|121|B|||
1905|122|R|STORAGE:  Not applicable. This medication is given in a hospital||
1905|123|R|or doctor's office and will not be stored at home.||
1905|124|B|||
1905|125|A|Information last revised May 2024.||
1905|126|A|Copyright(c) 2025 First Databank, Inc.||
1905|127|B|||
1906|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1906|002|Z|does NOT have all possible information about this product. This||
1906|003|Z|information does not assure that this product is safe, effective,||
1906|004|Z|or appropriate for you. This information is not individual||
1906|005|Z|medical advice and does not substitute for the advice of your||
1906|006|Z|health care professional. Always ask your health care||
1906|007|Z|professional for complete information about this product and your||
1906|008|Z|specific health needs.||
1906|009|B|||
1906|010|T|ERTUGLIFLOZIN/SITAGLIPTIN - ORAL||
1906|011|F|(ER-too-gli-FLOE-zin/SIT-a-GLIP-tin)||
1906|012|B|||
1906|013|C|COMMON BRAND NAME(S): Steglujan||
1906|014|B|||
1906|015|U|USES:  This medication is a combination of 2 drugs: ertugliflozin||
1906|016|U|and sitagliptin. It is used with a proper diet and exercise||
1906|017|U|program to control high blood sugar in people with type 2||
1906|018|U|diabetes. Controlling high blood sugar helps prevent kidney||
1906|019|U|damage, blindness, nerve problems, loss of limbs, and sexual||
1906|020|U|function problems. Proper control of diabetes may also lessen||
1906|021|U|your risk of a heart attack or stroke. Ertugliflozin works by||
1906|022|U|increasing the removal of sugar by your kidneys. Sitagliptin||
1906|023|U|works by increasing levels of natural substances called||
1906|024|U|incretins. Incretins help to control blood sugar by increasing||
1906|025|U|insulin release, especially after a meal. They also decrease the||
1906|026|U|amount of sugar your liver makes.||
1906|027|B|||
1906|028|H|HOW TO USE:  Read the Medication Guide provided by your||
1906|029|H|pharmacist before you start taking ertugliflozin/sitagliptin and||
1906|030|H|each time you get a refill. If you have any questions, ask your||
1906|031|H|doctor or pharmacist.||
1906|032|H|   Take this medication by mouth with or without food as directed||
1906|033|H|by your doctor, usually once daily in the morning. The dosage is||
1906|034|H|based on your medical condition and response to treatment.||
1906|035|H|   Use this medication regularly to get the most benefit from it.||
1906|036|H|To help you remember, take it at the same time each day.||
1906|037|H|   Tell your doctor if your condition does not get better or if||
1906|038|H|it gets worse (your blood sugar is too high or too low).||
1906|039|B|||
1906|040|S|SIDE EFFECTS:  Dizziness, lightheadedness, or frequent urination||
1906|041|S|may occur. If any of these effects last or get worse, tell your||
1906|042|S|doctor or pharmacist promptly.||
1906|043|S|   To reduce the risk of dizziness and lightheadedness, get up||
1906|044|S|slowly when rising from a sitting or lying position.||
1906|045|S|   Remember that this medication has been prescribed because your||
1906|046|S|doctor has judged that the benefit to you is greater than the||
1906|047|S|risk of side effects. Many people using this medication do not||
1906|048|S|have serious side effects.||
1906|049|S|   Tell your doctor right away if you have any serious side||
1906|050|S|effects, including: signs of a urinary tract infection (such as||
1906|051|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1906|052|S|signs of kidney problems (such as change in the amount of urine,||
1906|053|S|swelling legs/feet), joint pain, unusual skin blisters, signs of||
1906|054|S|heart failure (such as shortness of breath, swelling ankles/feet,||
1906|055|S|unusual tiredness, unusual/sudden weight gain).||
1906|056|S|   Get medical help right away if you have any very serious side||
1906|057|S|effects, including: signs of pancreatitis (such as||
1906|058|S|nausea/vomiting that doesn't stop, loss of appetite, severe||
1906|059|S|stomach/abdominal/back pain), unusual tiredness, trouble||
1906|060|S|breathing.||
1906|061|S|   This medication may cause a new yeast infection in the vagina||
1906|062|S|or the penis. It may also cause a rare but very serious bacterial||
1906|063|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1906|064|S|your doctor right away if you have signs of a yeast infection in||
1906|065|S|the vagina (such as unusual vaginal||
1906|066|S|discharge/burning/itching/odor) or in the penis (such as||
1906|067|S|redness/itching/swelling of the penis, unusual discharge from the||
1906|068|S|penis). However, get medical help right away if you have any||
1906|069|S|pain/redness/swelling in or around the genital/anal area, along||
1906|070|S|with a fever or feeling unwell.||
1906|071|S|   This medication may increase the risk of lower limb amputation||
1906|072|S|(especially of the toe and foot). The risk is higher if you have||
1906|073|S|poor blood flow in the legs, nerve problems, foot ulcers, or have||
1906|074|S|had a previous amputation. To lessen the risk, check your feet||
1906|075|S|regularly and tell your doctor if you have new pain, tenderness,||
1906|076|S|sores, or ulcers on your legs or feet.||
1906|077|S|   This medication does not usually cause low blood sugar||
1906|078|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1906|079|S|prescribed with other diabetes medications, or if you do not get||
1906|080|S|enough calories from food, or if you do unusually heavy exercise.||
1906|081|S|Talk with your doctor or pharmacist about whether the dose of||
1906|082|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1906|083|S|of low blood sugar include sudden sweating, shaking, fast||
1906|084|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1906|085|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1906|086|S|treat low blood sugar. If you don't have these reliable forms of||
1906|087|S|glucose, rapidly raise your blood sugar by eating a quick source||
1906|088|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1906|089|S|juice or non-diet soda. Tell your doctor right away about the||
1906|090|S|reaction and the use of this product. To help prevent low blood||
1906|091|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1906|092|S|Check with your doctor or pharmacist to find out what you should||
1906|093|S|do if you miss a meal.||
1906|094|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1906|095|S|thirst/urination. If these symptoms occur, tell your doctor right||
1906|096|S|away. Your doctor may need to adjust your diabetes medication,||
1906|097|S|exercise program, or diet.||
1906|098|S|   This medication may cause you to become dehydrated. This can||
1906|099|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1906|100|S|dehydration. Tell your doctor or pharmacist right away if you are||
1906|101|S|not able to drink fluids as usual, or losing fluid (such as due||
1906|102|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1906|103|S|right away if you have any signs of dehydration, such as||
1906|104|S|urinating less than usual, unusual dry mouth/thirst, fast||
1906|105|S|heartbeat, or dizziness/lightheadedness/fainting.||
1906|106|S|   A very serious allergic reaction to this drug is rare.||
1906|107|S|However, get medical help right away if you notice any symptoms||
1906|108|S|of a serious allergic reaction, including: rash, itching/swelling||
1906|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1906|110|S|breathing.||
1906|111|S|   This is not a complete list of possible side effects. If you||
1906|112|S|notice other effects not listed above, contact your doctor or||
1906|113|S|pharmacist.||
1906|114|S|   In the US -||
1906|115|S|   Call your doctor for medical advice about side effects. You||
1906|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1906|117|S|www.fda.gov/medwatch.||
1906|118|S|   In Canada - Call your doctor for medical advice about side||
1906|119|S|effects. You may report side effects to Health Canada at||
1906|120|S|1-866-234-2345.||
1906|121|B|||
1906|122|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1906|123|P|pharmacist if you are allergic to ertugliflozin or sitagliptin;||
1906|124|P|or if you have any other allergies. This product may contain||
1906|125|P|inactive ingredients, which can cause allergic reactions or other||
1906|126|P|problems. Talk to your pharmacist for more details.||
1906|127|P|   Before using this medication, tell your doctor or pharmacist||
1906|128|P|your medical history, especially of: kidney disease/failure||
1906|129|P|(dialysis), heart failure, dehydration, low blood pressure,||
1906|130|P|disease of the pancreas (pancreatitis), use/abuse of alcohol,||
1906|131|P|stones in your gallbladder (gallstones), yeast infections in the||
1906|132|P|vagina or penis, blocked or narrowed blood vessels, usually in||
1906|133|P|the leg, nerve problems (such as diabetic peripheral neuropathy),||
1906|134|P|foot sores or ulcers, amputation.||
1906|135|P|   You may experience blurred vision, dizziness, or drowsiness||
1906|136|P|due to extremely low or high blood sugar. Do not drive, use||
1906|137|P|machinery, or do anything that needs alertness until you can do||
1906|138|P|it safely.||
1906|139|P|   Limit alcohol while taking this medication because it can||
1906|140|P|increase your risk of developing low blood sugar and a high||
1906|141|P|ketone level.||
1906|142|P|   It may be harder to control your blood sugar when your body is||
1906|143|P|stressed (such as due to fever, infection, injury, or surgery).||
1906|144|P|Also, if you are eating less or not able to eat due to these||
1906|145|P|conditions or any illness, this can lead to a high ketone level||
1906|146|P|while you are taking this medication. Consult your doctor because||
1906|147|P|this may require a change in your treatment plan, medications, or||
1906|148|P|blood sugar or ketone testing.||
1906|149|P|   Before having surgery, tell your doctor or dentist about all||
1906|150|P|the products you use (including prescription drugs,||
1906|151|P|nonprescription drugs, and herbal products).||
1906|152|P|   Older adults may be more sensitive to the side effects of this||
1906|153|P|drug, especially dizziness/fainting (usually when standing),||
1906|154|P|dehydration, and kidney disease.||
1906|155|P|   During pregnancy, this medication should be used only when||
1906|156|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1906|157|P|benefits with your doctor.||
1906|158|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1906|159|P|your doctor for managing your blood sugar while pregnant. Your||
1906|160|P|doctor may change your diabetes treatment during your pregnancy||
1906|161|P|(such as diet and medications including insulin).||
1906|162|P|   It is unknown if this drug passes into breast milk. Consult||
1906|163|P|your doctor before breastfeeding.||
1906|164|B|||
1906|165|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1906|166|I|medications work or increase your risk for serious side effects.||
1906|167|I|This document does not contain all possible drug interactions.||
1906|168|I|Keep a list of all the products you use (including||
1906|169|I|prescription/nonprescription drugs and herbal products) and share||
1906|170|I|it with your doctor and pharmacist. Do not start, stop, or change||
1906|171|I|the dosage of any medicines without your doctor's approval.||
1906|172|I|   Beta blocker medications (such as metoprolol, propranolol,||
1906|173|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1906|174|I|heartbeat you would usually feel when your blood sugar falls too||
1906|175|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1906|176|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1906|177|I|   Many drugs can affect your blood sugar, making it harder to||
1906|178|I|control. Before you start, stop, or change any medication, talk||
1906|179|I|with your doctor or pharmacist about how the medication may||
1906|180|I|affect your blood sugar. Check your blood sugar regularly as||
1906|181|I|directed and share the results with your doctor. Tell your doctor||
1906|182|I|right away if you have symptoms of high or low blood sugar. (See||
1906|183|I|also Side Effects section.) Your doctor may need to adjust your||
1906|184|I|diabetes medication, exercise program, or diet.||
1906|185|I|   Your urine will test positive for glucose. Make sure lab||
1906|186|I|personnel and all your doctors know you use this drug.||
1906|187|B|||
1906|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1906|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1906|190|O|poison control center right away. US residents can call||
1906|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1906|192|B|||
1906|193|N|NOTES:  Do not share this medication with others.||
1906|194|N|   Attend a diabetes education program to learn more about how to||
1906|195|N|manage your diabetes with medications, diet, exercise, foot care,||
1906|196|N|and regular medical exams.||
1906|197|N|   Learn the symptoms of high and low blood sugar and how to||
1906|198|N|treat low blood sugar. Check your blood sugar regularly as||
1906|199|N|directed.||
1906|200|N|   Lab and/or medical tests (such as kidney function, liver||
1906|201|N|function, blood sugar, hemoglobin A1c, cholesterol, ketones)||
1906|202|N|should be done before you start taking this medication and while||
1906|203|N|you are taking it. Keep all medical and lab appointments. Consult||
1906|204|N|your doctor for more details.||
1906|205|B|||
1906|206|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1906|207|D|remember. If it is near the time of the next dose, skip the||
1906|208|D|missed dose. Take your next dose at the regular time. Do not||
1906|209|D|double the dose to catch up.||
1906|210|B|||
1906|211|R|STORAGE:  Store at room temperature away from light and moisture.||
1906|212|R|Do not store in the bathroom. Keep all medications away from||
1906|213|R|children and pets.||
1906|214|R|   Do not flush medications down the toilet or pour them into a||
1906|215|R|drain unless instructed to do so. Properly discard this product||
1906|216|R|when it is expired or no longer needed. Consult your pharmacist||
1906|217|R|or local waste disposal company.||
1906|218|B|||
1906|219|M|MEDICAL ALERT:  Your condition can cause complications in a||
1906|220|M|medical emergency. For information about enrolling in MedicAlert,||
1906|221|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1906|222|B|||
1906|223|A|Information last revised May 2025.||
1906|224|A|Copyright(c) 2025 First Databank, Inc.||
1906|225|B|||
1907|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1907|002|Z|does NOT have all possible information about this product. This||
1907|003|Z|information does not assure that this product is safe, effective,||
1907|004|Z|or appropriate for you. This information is not individual||
1907|005|Z|medical advice and does not substitute for the advice of your||
1907|006|Z|health care professional. Always ask your health care||
1907|007|Z|professional for complete information about this product and your||
1907|008|Z|specific health needs.||
1907|009|B|||
1907|010|T|CLADRIBINE - ORAL||
1907|011|F|(KLAD-ri-been)||
1907|012|B|||
1907|013|C|COMMON BRAND NAME(S): Mavenclad||
1907|014|B|||
1907|015|W|WARNING:  Cladribine may rarely increase your risk of getting||
1907|016|W|cancer. Do not take this medication if you have cancer. Discuss||
1907|017|W|the risks and benefits with your doctor if you have had cancer in||
1907|018|W|the past or are at increased risk for cancer. Talk to your doctor||
1907|019|W|about getting regularly screened for cancer. Tell your doctor||
1907|020|W|right away if you have symptoms such as a change in size/color of||
1907|021|W|a mole, unusual skin changes, new lumps/growths, night sweats, or||
1907|022|W|unexplained/sudden weight loss. Ask your doctor for more details.||
1907|023|W|   This medication must not be used during pregnancy. It may harm||
1907|024|W|an unborn baby. Your doctor will order a pregnancy test before||
1907|025|W|you start this medication. It is important to prevent pregnancy||
1907|026|W|while taking this medication and for at least 6 months after each||
1907|027|W|treatment course. Men and women using this medication must use||
1907|028|W|reliable forms of birth control during treatment and for at least||
1907|029|W|6 months after the last dose. If you or your partner become||
1907|030|W|pregnant or think you may be pregnant, tell your doctor right||
1907|031|W|away.||
1907|032|B|||
1907|033|U|USES:  Cladribine is used to treat relapsing forms of multiple||
1907|034|U|sclerosis (MS). It is not a cure for MS but it is thought to help||
1907|035|U|by preventing immune system cells (lymphocytes) from attacking||
1907|036|U|the nerves in your brain and spinal cord. It may help to slow||
1907|037|U|disease worsening and decrease flare-ups of symptoms.||
1907|038|B|||
1907|039|H|HOW TO USE:  Read the Medication Guide provided by your||
1907|040|H|pharmacist before you start taking cladribine and each time you||
1907|041|H|get a refill. If you have any questions, ask your doctor or||
1907|042|H|pharmacist.||
1907|043|H|   Take this medication by mouth with or without food as directed||
1907|044|H|by your doctor. The dosage is based on your medical condition,||
1907|045|H|weight, and response to treatment. You should usually only take||
1907|046|H|this medication for 2 treatment weeks (with about a month||
1907|047|H|separating each treatment week) each year for 2 years. After||
1907|048|H|completing the 2-year treatment course, do not take cladribine||
1907|049|H|during the next 2 years. Follow your doctor's instructions||
1907|050|H|carefully.||
1907|051|H|   Wash and dry your hands before handling this medication.||
1907|052|H|Swallow the tablet(s) whole. Do not crush or chew the tablets.||
1907|053|H|After taking the medication, wash your hands with soap and water.||
1907|054|H|   Take this medication at least 3 hours before or after taking||
1907|055|H|other medications.||
1907|056|H|   If the tablet breaks, avoid inhaling the powder or dust, and||
1907|057|H|avoid direct contact with the skin or eyes. If contact occurs,||
1907|058|H|wash the affected skin well with soap and water or rinse your||
1907|059|H|eyes with plain water. Consult your pharmacist for details.||
1907|060|H|   Since this drug can be absorbed through the skin and lungs and||
1907|061|H|may harm an unborn baby, women who are pregnant or who may become||
1907|062|H|pregnant should not handle this medication or breathe the dust||
1907|063|H|from the tablets.||
1907|064|B|||
1907|065|S|SIDE EFFECTS:  See also Warning section.||
1907|066|S|   Nausea, headache, back pain, or stomach/abdominal pain may||
1907|067|S|occur. If any of these effects last or get worse, tell your||
1907|068|S|doctor or pharmacist promptly.||
1907|069|S|   People using this medication may have serious side effects.||
1907|070|S|However, you have been prescribed this drug because your doctor||
1907|071|S|has judged that the benefit to you is greater than the risk of||
1907|072|S|side effects. Careful monitoring by your doctor may decrease your||
1907|073|S|risk.||
1907|074|S|   Tell your doctor right away if you have any serious side||
1907|075|S|effects, including: signs of liver problems (such as||
1907|076|S|nausea/vomiting that doesn't stop, loss of appetite, severe||
1907|077|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1907|078|S|   This medication decreases bone marrow function, an effect that||
1907|079|S|may lead to a low number of blood cells such as red cells, white||
1907|080|S|cells, and platelets. This effect can cause anemia, decrease your||
1907|081|S|body's ability to fight an infection, or cause easy||
1907|082|S|bruising/bleeding. Tell your doctor right away if you develop any||
1907|083|S|of the following symptoms: unusual tiredness, pale skin, signs of||
1907|084|S|infection (such as sore throat that doesn't go away, fever,||
1907|085|S|chills, painful rash/sores, frequent/painful urination), easy||
1907|086|S|bruising/bleeding.||
1907|087|S|   This medication may increase your risk of getting a rare but||
1907|088|S|very serious (possibly fatal) brain infection (progressive||
1907|089|S|multifocal leukoencephalopathy-PML). Get medical help right away||
1907|090|S|if you have any of these side effects: clumsiness, loss of||
1907|091|S|coordination/balance, weakness, sudden change in your thinking||
1907|092|S|(such as confusion, difficulty concentrating, memory loss),||
1907|093|S|difficulty talking/walking, seizure, vision changes.||
1907|094|S|   Get medical help right away if you have any very serious side||
1907|095|S|effects, including: shortness of breath, fast/irregular||
1907|096|S|heartbeat, swelling of the ankles/feet.||
1907|097|S|   A very serious allergic reaction to this drug is rare.||
1907|098|S|However, get medical help right away if you notice any symptoms||
1907|099|S|of a serious allergic reaction, including: rash, itching/swelling||
1907|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1907|101|S|breathing.||
1907|102|S|   This is not a complete list of possible side effects. If you||
1907|103|S|notice other effects not listed above, contact your doctor or||
1907|104|S|pharmacist.||
1907|105|S|   In the US -||
1907|106|S|   Call your doctor for medical advice about side effects. You||
1907|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1907|108|S|www.fda.gov/medwatch.||
1907|109|S|   In Canada - Call your doctor for medical advice about side||
1907|110|S|effects. You may report side effects to Health Canada at||
1907|111|S|1-866-234-2345.||
1907|112|B|||
1907|113|P|PRECAUTIONS:  Before taking cladribine, tell your doctor or||
1907|114|P|pharmacist if you are allergic to it; or if you have any other||
1907|115|P|allergies. This product may contain inactive ingredients, which||
1907|116|P|can cause allergic reactions or other problems. Talk to your||
1907|117|P|pharmacist for more details.||
1907|118|P|   Before using this medication, tell your doctor or pharmacist||
1907|119|P|your medical history, especially of: kidney disease, liver||
1907|120|P|disease (such as hepatitis B or C), nerve/muscle disorder,||
1907|121|P|blood/bone marrow disorder, current/recent/returning infections||
1907|122|P|(such as tuberculosis, herpes, shingles, HIV), cancer, heart||
1907|123|P|failure.||
1907|124|P|   Before having surgery, tell your doctor or dentist about all||
1907|125|P|the products you use (including prescription drugs,||
1907|126|P|nonprescription drugs, and herbal products).||
1907|127|P|   Tell your doctor that you are taking cladribine before getting||
1907|128|P|a blood transfusion.||
1907|129|P|   Cladribine can make you more likely to get infections or may||
1907|130|P|make current infections worse. Stay away from anyone who has an||
1907|131|P|infection that may easily spread (such as chickenpox, COVID-19,||
1907|132|P|measles, flu). Talk to your doctor if you have been exposed to an||
1907|133|P|infection or for more details.||
1907|134|P|   Tell your health care professional that you are using||
1907|135|P|cladribine before having any immunizations/vaccinations. Avoid||
1907|136|P|contact with people who have recently received live vaccines||
1907|137|P|(such as flu vaccine inhaled through the nose).||
1907|138|P|   To lower the chance of getting cut, bruised, or injured, use||
1907|139|P|caution with sharp objects like razors and nail cutters, and||
1907|140|P|avoid activities such as contact sports.||
1907|141|P|   Since this drug can be absorbed through the skin and lungs and||
1907|142|P|may harm an unborn baby, women who are pregnant or who may become||
1907|143|P|pregnant should not handle this medication or breathe the dust||
1907|144|P|from the tablets.||
1907|145|P|   This medication must not be used during pregnancy. It may harm||
1907|146|P|an unborn baby. It is important to prevent pregnancy while taking||
1907|147|P|this medication and for at least 6 months after each treatment||
1907|148|P|course. If you or your partner become pregnant or think you may||
1907|149|P|be pregnant, tell your doctor right away. See also Warning||
1907|150|P|section.||
1907|151|P|   This drug passes into breast milk. Because of the possible||
1907|152|P|risk to the infant, breastfeeding is not recommended while taking||
1907|153|P|this drug and for 10 days after the last dose. Consult your||
1907|154|P|doctor before breastfeeding.||
1907|155|B|||
1907|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1907|157|I|medications work or increase your risk for serious side effects.||
1907|158|I|This document does not contain all possible drug interactions.||
1907|159|I|Keep a list of all the products you use (including||
1907|160|I|prescription/nonprescription drugs and herbal products) and share||
1907|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
1907|162|I|the dosage of any medicines without your doctor's approval.||
1907|163|I|   Some products that may interact with this drug are: other||
1907|164|I|drugs that weaken the immune system/increase the risk of||
1907|165|I|infection (such as cyclosporine, natalizumab, rituximab, drugs to||
1907|166|I|treat cancer like irinotecan).||
1907|167|B|||
1907|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1907|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1907|170|O|poison control center right away. US residents can call||
1907|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1907|172|B|||
1907|173|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1907|174|N|TB test, HIV test, hepatitis B and C screening, liver function,||
1907|175|N|MRI of the brain, cancer screening) should be done before you||
1907|176|N|start taking this medication and while you are taking it. Keep||
1907|177|N|all medical and lab appointments. Consult your doctor for more||
1907|178|N|details.||
1907|179|B|||
1907|180|D|MISSED DOSE:  It is important to get each dose of this medication||
1907|181|D|as scheduled. If you miss a dose, take it as soon as you remember||
1907|182|D|on the same day. If you miss a day, take the missed dose the next||
1907|183|D|day and extend the treatment week. Do not take more than 1 dose||
1907|184|D|each day. Do not double the dose to catch up.||
1907|185|B|||
1907|186|R|STORAGE:  Store in the original package at room temperature away||
1907|187|R|from light and moisture. Do not store in the bathroom. Keep all||
1907|188|R|medications away from children and pets.||
1907|189|R|   Do not flush medications down the toilet or pour them into a||
1907|190|R|drain unless instructed to do so. Properly discard this product||
1907|191|R|when it is expired or no longer needed. Consult your pharmacist||
1907|192|R|or local waste disposal company.||
1907|193|B|||
1907|194|M|MEDICAL ALERT:  Your condition can cause complications in a||
1907|195|M|medical emergency. For information about enrolling in MedicAlert,||
1907|196|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1907|197|B|||
1907|198|A|Information last revised September 2025.||
1907|199|A|Copyright(c) 2025 First Databank, Inc.||
1907|200|B|||
1908|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1908|002|Z|does NOT have all possible information about this product. This||
1908|003|Z|information does not assure that this product is safe, effective,||
1908|004|Z|or appropriate for you. This information is not individual||
1908|005|Z|medical advice and does not substitute for the advice of your||
1908|006|Z|health care professional. Always ask your health care||
1908|007|Z|professional for complete information about this product and your||
1908|008|Z|specific health needs.||
1908|009|B|||
1908|010|T|DESMOPRESSIN SPRAY (NOCTURIA) - NASAL||
1908|011|F|(DES-moe-PRES-in)||
1908|012|B|||
1908|013|C|COMMON BRAND NAME(S): Noctiva||
1908|014|B|||
1908|015|W|WARNING:  Desmopressin can rarely cause a low level of sodium in||
1908|016|W|the blood (hyponatremia), which can be serious or even fatal.||
1908|017|W|Drinking too much liquid, using certain medications (such as||
1908|018|W|"water pills"/diuretics including furosemide, corticosteroids||
1908|019|W|such as prednisone), being 65 years or older, or having certain||
1908|020|W|medical conditions may increase the risk of low sodium in the||
1908|021|W|blood. Lab tests (such as urine tests, sodium blood levels) must||
1908|022|W|be done before you start using this medication and while you are||
1908|023|W|using it. Keep all medical and lab appointments.||
1908|024|W|   Tell your doctor right away if you develop symptoms of low||
1908|025|W|sodium in the blood, such as nausea, vomiting, headache, muscle||
1908|026|W|weakness/cramps, unusual tiredness, unusual drowsiness,||
1908|027|W|dizziness, restlessness, mental/mood changes including||
1908|028|W|confusion/irritability.||
1908|029|W|   Get medical help right away if you have any very serious side||
1908|030|W|effects, including seizure or trouble breathing.||
1908|031|B|||
1908|032|U|USES:  Desmopressin is a man-made form of vasopressin.||
1908|033|U|Vasopressin is a substance in your body that helps control how||
1908|034|U|much urine you make. This medication is used by adults who wake||
1908|035|U|up 2 or more times during the night to urinate due to a condition||
1908|036|U|called nocturnal polyuria. This is a condition where your body||
1908|037|U|makes too much urine at night. Other conditions can also cause||
1908|038|U|you to wake up at night to urinate, so you will receive this||
1908|039|U|treatment only after tests by your doctor show you have this||
1908|040|U|condition.||
1908|041|U|   Do not use this medication to treat children who wet the bed||
1908|042|U|at night.||
1908|043|B|||
1908|044|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1908|045|H|provided by your pharmacist before you start using desmopressin||
1908|046|H|and each time you get a refill. If you have any questions, ask||
1908|047|H|your doctor or pharmacist.||
1908|048|H|   Follow the instructions to properly prime the bottle if you||
1908|049|H|are using it for the first time or if you have not used it for||
1908|050|H|more than 3 days. Do not shake the bottle. Before using, blow||
1908|051|H|your nose to clear your nostrils. Spray this medication in the||
1908|052|H|nose as directed by your doctor, usually once daily, about 30||
1908|053|H|minutes before going to bed.||
1908|054|H|   Limit drinking water and other fluids close to bedtime while||
1908|055|H|using this medication. Consult your doctor for details.||
1908|056|H|   The dosage is based on your medical condition, age, and||
1908|057|H|response to treatment. Do not use more desmopressin or use it||
1908|058|H|more often than prescribed.||
1908|059|H|   Use this medication regularly to get the most benefit from it.||
1908|060|H|To help you remember, use it at the same time each day.||
1908|061|H|   If you develop nose problems (such as blockage, runny/stuffy||
1908|062|H|nose due to a cold) while using this medication, tell your doctor||
1908|063|H|right away. Your doctor may direct you to temporarily stop using||
1908|064|H|this medication until your symptoms get better.||
1908|065|H|   Tell your doctor if your condition does not get better or if||
1908|066|H|it gets worse.||
1908|067|B|||
1908|068|S|SIDE EFFECTS:  See also Warning section.||
1908|069|S|   Nose discomfort, runny/stuffy nose, nose bleed, or sneezing||
1908|070|S|may occur. If any of these effects last or get worse, tell your||
1908|071|S|doctor or pharmacist promptly.||
1908|072|S|   Remember that this medication has been prescribed because your||
1908|073|S|doctor has judged that the benefit to you is greater than the||
1908|074|S|risk of side effects. Many people using this medication do not||
1908|075|S|have serious side effects.||
1908|076|S|   This medication may raise your blood pressure. Check your||
1908|077|S|blood pressure regularly and tell your doctor if the results are||
1908|078|S|high.||
1908|079|S|   A very serious allergic reaction to this drug is rare.||
1908|080|S|However, get medical help right away if you notice any symptoms||
1908|081|S|of a serious allergic reaction, including: rash, itching/swelling||
1908|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1908|083|S|breathing.||
1908|084|S|   This is not a complete list of possible side effects. If you||
1908|085|S|notice other effects not listed above, contact your doctor or||
1908|086|S|pharmacist.||
1908|087|S|   In the US -||
1908|088|S|   Call your doctor for medical advice about side effects. You||
1908|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1908|090|S|www.fda.gov/medwatch.||
1908|091|S|   In Canada - Call your doctor for medical advice about side||
1908|092|S|effects. You may report side effects to Health Canada at||
1908|093|S|1-866-234-2345.||
1908|094|B|||
1908|095|P|PRECAUTIONS:  Before using desmopressin, tell your doctor or||
1908|096|P|pharmacist if you are allergic to it; or if you have any other||
1908|097|P|allergies. This product may contain inactive ingredients, which||
1908|098|P|can cause allergic reactions or other problems. Talk to your||
1908|099|P|pharmacist for more details.||
1908|100|P|   Before using this medication, tell your doctor or pharmacist||
1908|101|P|your medical history, especially of: kidney disease, heart||
1908|102|P|problems (such as blocked blood vessels, heart failure), high||
1908|103|P|blood pressure, nose problems (such as blockage, runny/stuffy||
1908|104|P|nose), the urge to drink too much water without being thirsty,||
1908|105|P|conditions that may increase your risk of fluid/mineral imbalance||
1908|106|P|(such as urinary retention), a low level of sodium in the blood||
1908|107|P|(hyponatremia), a certain brain disorder (syndrome of||
1908|108|P|inappropriate antidiuretic hormone secretion).||
1908|109|P|   Tell the doctor right away if you develop any illness that can||
1908|110|P|cause water/mineral imbalance (including fever, diarrhea,||
1908|111|P|vomiting, infections such as flu) or if you have conditions that||
1908|112|P|require drinking more fluids (for example, exposure to very hot||
1908|113|P|weather, strenuous exercise). The doctor may need to stop or||
1908|114|P|adjust desmopressin treatment.||
1908|115|P|   Before having surgery, tell your doctor or dentist about all||
1908|116|P|the products you use (such as prescription drugs, nonprescription||
1908|117|P|drugs, and herbal products).||
1908|118|P|   Older adults may be at greater risk for water/mineral||
1908|119|P|imbalance and low levels of sodium in the blood while using this||
1908|120|P|drug.||
1908|121|P|   During pregnancy, this medication should be used only when||
1908|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
1908|123|P|   This medication passes into breast milk in small amounts.||
1908|124|P|Consult your doctor before breastfeeding.||
1908|125|B|||
1908|126|I|DRUG INTERACTIONS:  See also Warning section.||
1908|127|I|   Drug interactions may change how your medications work or||
1908|128|I|increase your risk for serious side effects. This document does||
1908|129|I|not contain all possible drug interactions. Keep a list of all||
1908|130|I|the products you use (including prescription/nonprescription||
1908|131|I|drugs and herbal products) and share it with your doctor and||
1908|132|I|pharmacist. Do not start, stop, or change the dosage of any||
1908|133|I|medicines without your doctor's approval.||
1908|134|I|   Some products that may interact with this drug are:||
1908|135|I|corticosteroids that are taken by mouth or inhaled (such as||
1908|136|I|fluticasone, prednisone), tolvaptan, "water pills"/diuretics||
1908|137|I|(such as furosemide).||
1908|138|B|||
1908|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1908|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1908|141|O|poison control center right away. US residents can call||
1908|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1908|143|O|Symptoms of overdose may include: confusion, seizure.||
1908|144|B|||
1908|145|N|NOTES:  Do not share this medication with others.||
1908|146|B|||
1908|147|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1908|148|D|next dose at the regular time. Do not double the dose to catch||
1908|149|D|up.||
1908|150|B|||
1908|151|R|STORAGE:  Store the unopened bottle upright in the refrigerator.||
1908|152|R|Store the opened bottle upright at room temperature. Once the||
1908|153|R|bottle is opened, this medication expires after 60 days. Keep all||
1908|154|R|medications away from children and pets.||
1908|155|R|   Do not flush medications down the toilet or pour them into a||
1908|156|R|drain unless instructed to do so. Properly discard this product||
1908|157|R|when it is expired or no longer needed. Consult your pharmacist||
1908|158|R|or local waste disposal company.||
1908|159|B|||
1908|160|A|Information last revised September 2024.||
1908|161|A|Copyright(c) 2025 First Databank, Inc.||
1908|162|B|||
1909|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1909|002|Z|does NOT have all possible information about this product. This||
1909|003|Z|information does not assure that this product is safe, effective,||
1909|004|Z|or appropriate for you. This information is not individual||
1909|005|Z|medical advice and does not substitute for the advice of your||
1909|006|Z|health care professional. Always ask your health care||
1909|007|Z|professional for complete information about this product and your||
1909|008|Z|specific health needs.||
1909|009|B|||
1909|010|T|ERTUGLIFLOZIN/METFORMIN - ORAL||
1909|011|F|(ER-too-gli-FLOE-zin/met-FOR-min)||
1909|012|B|||
1909|013|C|COMMON BRAND NAME(S): Segluromet||
1909|014|B|||
1909|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
1909|016|W|cause a serious (sometimes fatal) condition called lactic||
1909|017|W|acidosis. Lactic acidosis is more likely if you are an older||
1909|018|W|adult, if you have kidney or liver disease, dehydration, heart||
1909|019|W|failure, heavy alcohol use, if you have surgery, if you have||
1909|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
1909|021|W|you are using certain drugs. For some conditions, your doctor may||
1909|022|W|tell you to stop taking this medication for a short time. Ask||
1909|023|W|your doctor or pharmacist for more details.||
1909|024|W|   Stop taking this medication and get medical help right away if||
1909|025|W|you have any symptoms of lactic acidosis, such as unusual||
1909|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1909|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1909|028|W|or stomach pain with nausea/vomiting/diarrhea.||
1909|029|B|||
1909|030|U|USES:  This medication is a combination of 2 drugs: ertugliflozin||
1909|031|U|and metformin. It is used with a proper diet and exercise program||
1909|032|U|to control high blood sugar in people with type 2 diabetes.||
1909|033|U|Controlling high blood sugar helps prevent kidney damage,||
1909|034|U|blindness, nerve problems, loss of limbs, and sexual function||
1909|035|U|problems. Proper control of diabetes may also lessen your risk of||
1909|036|U|a heart attack or stroke. This medication works by helping to||
1909|037|U|restore your body's proper response to the insulin you naturally||
1909|038|U|produce. It also increases the removal of sugar by your kidneys,||
1909|039|U|decreases how much sugar is made in your liver, and decreases how||
1909|040|U|much sugar your body takes in through your stomach and||
1909|041|U|intestines.||
1909|042|B|||
1909|043|H|HOW TO USE:  Read the Medication Guide provided by your||
1909|044|H|pharmacist before you start taking this medication and each time||
1909|045|H|you get a refill. If you have any questions, ask your doctor or||
1909|046|H|pharmacist.||
1909|047|H|   Take this medication by mouth as directed by your doctor,||
1909|048|H|usually 2 times a day with a meal.||
1909|049|H|   The dosage is based on your medical condition, response to||
1909|050|H|treatment, and other medications you may be taking. Be sure to||
1909|051|H|tell your doctor and pharmacist about all the products you use||
1909|052|H|(including prescription drugs, nonprescription drugs, and herbal||
1909|053|H|products).||
1909|054|H|   Take this medication regularly to get the most benefit from||
1909|055|H|it. To help you remember, take it at the same times each day.||
1909|056|H|   Tell your doctor if your condition does not get better or if||
1909|057|H|it gets worse (your blood sugar is too high or too low).||
1909|058|B|||
1909|059|S|SIDE EFFECTS:  See also Warning section.||
1909|060|S|   Diarrhea, nausea, vomiting, bloating/gas, headache, weakness,||
1909|061|S|or increased urination may occur. If any of these effects last or||
1909|062|S|get worse, tell your doctor or pharmacist promptly. If stomach||
1909|063|S|symptoms return later (after taking the same dose for several||
1909|064|S|days or weeks), tell your doctor right away. Stomach symptoms||
1909|065|S|that occur after the first days of your treatment may be signs of||
1909|066|S|lactic acidosis.||
1909|067|S|   Remember that this medication has been prescribed because your||
1909|068|S|doctor has judged that the benefit to you is greater than the||
1909|069|S|risk of side effects. Many people using this medication do not||
1909|070|S|have serious side effects.||
1909|071|S|   Tell your doctor right away if you have any serious side||
1909|072|S|effects, including: signs of a urinary tract infection (such as||
1909|073|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
1909|074|S|signs of kidney problems (such as change in the amount of urine,||
1909|075|S|swelling legs/feet).||
1909|076|S|   This medication may cause a new yeast infection in the vagina||
1909|077|S|or the penis. It may also cause a rare but very serious bacterial||
1909|078|S|infection in the genital/anal area (Fournier's gangrene). Tell||
1909|079|S|your doctor right away if you have signs of a yeast infection in||
1909|080|S|the vagina (such as unusual vaginal||
1909|081|S|discharge/burning/itching/odor) or in the penis (such as||
1909|082|S|redness/itching/swelling of the penis, unusual discharge from the||
1909|083|S|penis). However, get medical help right away if you have any||
1909|084|S|pain/redness/swelling in or around the genital/anal area, along||
1909|085|S|with a fever or feeling unwell.||
1909|086|S|   This medication may increase the risk of lower limb amputation||
1909|087|S|(especially of the toe and foot). The risk is higher if you have||
1909|088|S|poor blood flow in the legs, nerve problems, foot ulcers, or have||
1909|089|S|had a previous amputation. To lessen the risk, check your feet||
1909|090|S|regularly and tell your doctor if you have new pain, tenderness,||
1909|091|S|sores, or ulcers on your legs or feet.||
1909|092|S|   This medication does not usually cause low blood sugar||
1909|093|S|(hypoglycemia). Low blood sugar may occur if this drug is||
1909|094|S|prescribed with other diabetes medications, or if you do not get||
1909|095|S|enough calories from food, or if you do unusually heavy exercise.||
1909|096|S|Talk with your doctor or pharmacist about whether the dose of||
1909|097|S|your other diabetes medication(s) needs to be lowered. Symptoms||
1909|098|S|of low blood sugar include sudden sweating, shaking, fast||
1909|099|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
1909|100|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
1909|101|S|treat low blood sugar. If you don't have these reliable forms of||
1909|102|S|glucose, rapidly raise your blood sugar by eating a quick source||
1909|103|S|of sugar such as table sugar, honey, or candy, or drink fruit||
1909|104|S|juice or non-diet soda. Tell your doctor right away about the||
1909|105|S|reaction and the use of this product. To help prevent low blood||
1909|106|S|sugar, eat meals on a regular schedule, and do not skip meals.||
1909|107|S|Check with your doctor or pharmacist to find out what you should||
1909|108|S|do if you miss a meal.||
1909|109|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1909|110|S|thirst/urination. If these symptoms occur, tell your doctor right||
1909|111|S|away. Your doctor may need to adjust your diabetes medication,||
1909|112|S|exercise program, or diet.||
1909|113|S|   This medication may cause you to become dehydrated. This can||
1909|114|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
1909|115|S|dehydration. Tell your doctor or pharmacist right away if you are||
1909|116|S|not able to drink fluids as usual, or losing fluid (such as due||
1909|117|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
1909|118|S|right away if you have any signs of dehydration, such as||
1909|119|S|urinating less than usual, unusual dry mouth/thirst, fast||
1909|120|S|heartbeat, or dizziness/lightheadedness/fainting. To reduce the||
1909|121|S|risk of dizziness and lightheadedness, get up slowly when rising||
1909|122|S|from a sitting or lying position.||
1909|123|S|   A very serious allergic reaction to this drug is rare.||
1909|124|S|However, get medical help right away if you notice any symptoms||
1909|125|S|of a serious allergic reaction, including: rash, itching/swelling||
1909|126|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1909|127|S|breathing.||
1909|128|S|   This is not a complete list of possible side effects. If you||
1909|129|S|notice other effects not listed above, contact your doctor or||
1909|130|S|pharmacist.||
1909|131|S|   In the US -||
1909|132|S|   Call your doctor for medical advice about side effects. You||
1909|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1909|134|S|www.fda.gov/medwatch.||
1909|135|S|   In Canada - Call your doctor for medical advice about side||
1909|136|S|effects. You may report side effects to Health Canada at||
1909|137|S|1-866-234-2345.||
1909|138|B|||
1909|139|P|PRECAUTIONS:  See also Warning section.||
1909|140|P|   Before taking this medication, tell your doctor or pharmacist||
1909|141|P|if you are allergic to ertugliflozin or metformin; or if you have||
1909|142|P|any other allergies. This product may contain inactive||
1909|143|P|ingredients, which can cause allergic reactions or other||
1909|144|P|problems. Talk to your pharmacist for more details.||
1909|145|P|   Before using this medication, tell your doctor or pharmacist||
1909|146|P|your medical history, especially of: blood problems (such as||
1909|147|P|anemia, vitamin B12 deficiency), breathing problems (such as||
1909|148|P|asthma, obstructive lung disease), heart disease (such as heart||
1909|149|P|failure, recent heart attack), kidney disease/failure (dialysis),||
1909|150|P|liver problems, disease of the pancreas (pancreatitis), use/abuse||
1909|151|P|of alcohol, dehydration, low blood pressure, yeast infections in||
1909|152|P|the vagina or penis, blocked or narrowed blood vessels, usually||
1909|153|P|in the leg, nerve problems (such as diabetic peripheral||
1909|154|P|neuropathy), foot sores or ulcers, amputation.||
1909|155|P|   You may experience blurred vision, dizziness, or drowsiness||
1909|156|P|due to extremely low or high blood sugar. Do not drive, use||
1909|157|P|machinery, or do anything that needs alertness or clear vision||
1909|158|P|until you can do it safely.||
1909|159|P|   Limit alcohol while taking this medication because it can||
1909|160|P|increase your risk of developing lactic acidosis, low blood||
1909|161|P|sugar, and a high ketone level.||
1909|162|P|   High fever, "water pills" (diuretics such as||
1909|163|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
1909|164|P|may cause dehydration and increase your risk of lactic acidosis.||
1909|165|P|Stop taking this medication and tell your doctor right away if||
1909|166|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
1909|167|P|fluids to prevent dehydration unless your doctor directs you||
1909|168|P|otherwise.||
1909|169|P|   It may be harder to control your blood sugar when your body is||
1909|170|P|stressed (such as due to fever, infection, injury, or surgery).||
1909|171|P|Also, if you are eating less or not able to eat due to these||
1909|172|P|conditions or any illness, this can lead to a high ketone level||
1909|173|P|while you are taking this medication. Consult your doctor because||
1909|174|P|this may require a change in your treatment plan, medications, or||
1909|175|P|blood sugar or ketone testing.||
1909|176|P|   Before having surgery or any X-ray/scanning procedure using||
1909|177|P|iodinated contrast, tell your doctor or dentist about all the||
1909|178|P|products you use (including prescription drugs, nonprescription||
1909|179|P|drugs, and herbal products). You may need to stop this medication||
1909|180|P|for a short time for the surgery/procedure. Ask your doctor or||
1909|181|P|dentist for instructions before your surgery/procedure.||
1909|182|P|   Older adults may be more sensitive to the side effects of this||
1909|183|P|drug, especially low blood sugar, dehydration, lactic acidosis,||
1909|184|P|kidney problems, and low blood pressure.||
1909|185|P|   During pregnancy, this medication should be used only when||
1909|186|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1909|187|P|benefits with your doctor.||
1909|188|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
1909|189|P|your doctor for managing your blood sugar while pregnant. Your||
1909|190|P|doctor may change your diabetes treatment during your pregnancy||
1909|191|P|(such as diet and medications including insulin).||
1909|192|P|   Metformin can cause changes in the menstrual cycle (promote||
1909|193|P|ovulation) and increase the risk of becoming pregnant. Consult||
1909|194|P|your doctor or pharmacist about the use of reliable birth control||
1909|195|P|while using this medication.||
1909|196|P|   Metformin passes into breast milk in small amounts. It is||
1909|197|P|unknown if ertugliflozin passes into breast milk. Consult your||
1909|198|P|doctor before breastfeeding.||
1909|199|B|||
1909|200|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1909|201|I|medications work or increase your risk for serious side effects.||
1909|202|I|This document does not contain all possible drug interactions.||
1909|203|I|Keep a list of all the products you use (including||
1909|204|I|prescription/nonprescription drugs and herbal products) and share||
1909|205|I|it with your doctor and pharmacist. Do not start, stop, or change||
1909|206|I|the dosage of any medicines without your doctor's approval.||
1909|207|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1909|208|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1909|209|I|heartbeat you would usually feel when your blood sugar falls too||
1909|210|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1909|211|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
1909|212|I|   Many drugs can affect your blood sugar, making it harder to||
1909|213|I|control. Before you start, stop, or change any medication, talk||
1909|214|I|with your doctor or pharmacist about how the medication may||
1909|215|I|affect your blood sugar. Check your blood sugar regularly as||
1909|216|I|directed and share the results with your doctor. Tell your doctor||
1909|217|I|right away if you have symptoms of high or low blood sugar. (See||
1909|218|I|also Side Effects section.) Your doctor may need to adjust your||
1909|219|I|diabetes medication, exercise program, or diet.||
1909|220|I|   This medication may interfere with certain lab tests, possibly||
1909|221|I|causing false test results. Also, your urine will test positive||
1909|222|I|for glucose. Make sure lab personnel and all your doctors know||
1909|223|I|you use this drug.||
1909|224|B|||
1909|225|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1909|226|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1909|227|O|poison control center right away. US residents can call||
1909|228|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1909|229|O|Overdose can lead to lactic acidosis. Symptoms of overdose may||
1909|230|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
1909|231|O|rapid breathing, slow/irregular heartbeat.||
1909|232|B|||
1909|233|N|NOTES:  Do not share this medication with others.||
1909|234|N|   Attend a diabetes education program to learn more about how to||
1909|235|N|manage your diabetes with medications, diet, exercise, and||
1909|236|N|regular medical exams.||
1909|237|N|   Learn the symptoms of high and low blood sugar and how to||
1909|238|N|treat low blood sugar. Check your blood sugar regularly as||
1909|239|N|directed.||
1909|240|N|   Lab and/or medical tests (such as kidney function, liver||
1909|241|N|function, blood sugar, hemoglobin A1c, ketones, complete blood||
1909|242|N|counts, cholesterol, vitamin B12) should be done before you start||
1909|243|N|taking this medication and while you are taking it. Keep all||
1909|244|N|medical and lab appointments. Consult your doctor for more||
1909|245|N|details.||
1909|246|B|||
1909|247|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1909|248|D|remember. If it is near the time of the next dose, skip the||
1909|249|D|missed dose. Take your next dose at the regular time. Do not||
1909|250|D|double the dose to catch up.||
1909|251|B|||
1909|252|R|STORAGE:  Store at room temperature away from light and moisture.||
1909|253|R|Do not store in the bathroom. Keep all medications away from||
1909|254|R|children and pets.||
1909|255|R|   Do not flush medications down the toilet or pour them into a||
1909|256|R|drain unless instructed to do so. Properly discard this product||
1909|257|R|when it is expired or no longer needed. Consult your pharmacist||
1909|258|R|or local waste disposal company.||
1909|259|B|||
1909|260|M|MEDICAL ALERT:  Your condition can cause complications in a||
1909|261|M|medical emergency. For information about enrolling in MedicAlert,||
1909|262|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1909|263|B|||
1909|264|A|Information last revised April 2025.||
1909|265|A|Copyright(c) 2025 First Databank, Inc.||
1909|266|B|||
1910|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1910|002|Z|does NOT have all possible information about this product. This||
1910|003|Z|information does not assure that this product is safe, effective,||
1910|004|Z|or appropriate for you. This information is not individual||
1910|005|Z|medical advice and does not substitute for the advice of your||
1910|006|Z|health care professional. Always ask your health care||
1910|007|Z|professional for complete information about this product and your||
1910|008|Z|specific health needs.||
1910|009|B|||
1910|010|T|BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL||
1910|011|F|(bik-TEG-ra-vir/EM-trye-SYE-ta-been/ten-OF-oh-vir AL-a-FEN-a-mide)||
1910|012|B|||
1910|013|C|COMMON BRAND NAME(S): Biktarvy||
1910|014|B|||
1910|015|W|WARNING:  If you have hepatitis B infection as well as HIV, your||
1910|016|W|hepatitis symptoms may get worse or become very serious if you||
1910|017|W|stop taking this medication. Talk with your doctor before||
1910|018|W|stopping this medication. Your doctor will check your liver||
1910|019|W|function tests for several months after you stop. Tell your||
1910|020|W|doctor right away if you develop symptoms of worsening liver||
1910|021|W|problems.||
1910|022|B|||
1910|023|U|USES:  This combination product is used by itself to help control||
1910|024|U|HIV infection. It helps to decrease the amount of HIV in your||
1910|025|U|body so your immune system can work better. This lowers your||
1910|026|U|chance of getting HIV complications (such as new infections,||
1910|027|U|cancer) and improves your quality of life. This product is a||
1910|028|U|combination of 3 different drugs: bictegravir, emtricitabine, and||
1910|029|U|tenofovir alafenamide. Bictegravir is called an integrase strand||
1910|030|U|transfer inhibitor-INSTI. Emtricitabine is called a nucleoside||
1910|031|U|reverse transcriptase inhibitor, while tenofovir alafenamide is||
1910|032|U|called a nucleotide reverse transcriptase inhibitor.||
1910|033|U|Emtricitabine and tenofovir alafenamide are often called NRTIs.||
1910|034|U|   Bictegravir/emtricitabine/tenofovir alafenamide is not a cure||
1910|035|U|for HIV infection. To decrease your risk of spreading HIV disease||
1910|036|U|to others, continue to take all HIV medications exactly as||
1910|037|U|prescribed by your doctor. Use an effective barrier method (latex||
1910|038|U|or polyurethane condoms/dental dams) during sexual activity as||
1910|039|U|directed by your doctor. Do not share personal items (such as||
1910|040|U|needles/syringes, toothbrushes, and razors) that may have||
1910|041|U|contacted blood or other body fluids. Consult your doctor or||
1910|042|U|pharmacist for more details.||
1910|043|B|||
1910|044|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1910|045|H|from your pharmacist before you start taking||
1910|046|H|bictegravir/emtricitabine/tenofovir alafenamide and each time you||
1910|047|H|get a refill. If you have any questions, ask your doctor or||
1910|048|H|pharmacist.||
1910|049|H|   Take this medication by mouth with or without food as directed||
1910|050|H|by your doctor, usually once daily. The dosage is based on your||
1910|051|H|medical condition and response to treatment. Children's dosage is||
1910|052|H|also based on weight.||
1910|053|H|   For children unable to swallow a whole tablet, the tablet may||
1910|054|H|be split and each part taken separately. Take all parts of the||
1910|055|H|split tablet within about 10 minutes.||
1910|056|H|   If you are on dialysis, take your daily dose of this||
1910|057|H|medication after dialysis.||
1910|058|H|   If you are also taking antacids that contain aluminum or||
1910|059|H|magnesium, take this medication at least 2 hours before or at||
1910|060|H|least 6 hours after you take these antacids. If you are taking||
1910|061|H|iron or calcium products, take them with food at the same time||
1910|062|H|that you take this medication. Ask your doctor or pharmacist if||
1910|063|H|you have any questions.||
1910|064|H|   It is very important to keep taking this medication exactly as||
1910|065|H|prescribed by your doctor. Do not skip any doses.||
1910|066|H|   For the best effect, take this medication at evenly spaced||
1910|067|H|times. To help you remember, take this medication at the same||
1910|068|H|time every day.||
1910|069|H|   Do not take more or less of this drug than prescribed or stop||
1910|070|H|taking it even for a short time unless directed to do so by your||
1910|071|H|doctor. Doing so may cause the amount of virus to increase, make||
1910|072|H|the infection more difficult to treat (resistant), or worsen side||
1910|073|H|effects.||
1910|074|B|||
1910|075|S|SIDE EFFECTS:  Diarrhea, nausea, or headache may occur. If any of||
1910|076|S|these effects last or get worse, tell your doctor or pharmacist||
1910|077|S|promptly.||
1910|078|S|   Remember that this medication has been prescribed because your||
1910|079|S|doctor has judged that the benefit to you is greater than the||
1910|080|S|risk of side effects. Many people using this medication do not||
1910|081|S|have serious side effects.||
1910|082|S|   Tell your doctor right away if you have any serious side||
1910|083|S|effects, including: signs of kidney problems (such as change in||
1910|084|S|the amount of urine, pink/bloody urine), signs of liver problems||
1910|085|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
1910|086|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
1910|087|S|of a certain metabolism disorder-lactic acidosis (such as unusual||
1910|088|S|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
1910|089|S|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
1910|090|S|or stomach pain with nausea/vomiting/diarrhea).||
1910|091|S|   As your immune system gets stronger, it can begin to fight off||
1910|092|S|infections you already had, possibly causing disease symptoms to||
1910|093|S|come back. You could also have symptoms if your immune system||
1910|094|S|becomes overactive. This reaction may happen at any time (soon||
1910|095|S|after starting HIV treatment or many months later). Tell your||
1910|096|S|doctor right away if you have any serious symptoms, including:||
1910|097|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1910|098|S|that doesn't go away, headaches that are severe or don't go away,||
1910|099|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1910|100|S|changes, signs of infection (such as sore throat that doesn't go||
1910|101|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1910|102|S|sores), signs of an overactive thyroid (such as irritability,||
1910|103|S|nervousness, heat intolerance, fast/pounding/irregular||
1910|104|S|heartbeat).||
1910|105|S|   A very serious allergic reaction to this drug is rare.||
1910|106|S|However, get medical help right away if you notice any symptoms||
1910|107|S|of a serious allergic reaction, including: rash, itching/swelling||
1910|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1910|109|S|breathing.||
1910|110|S|   This is not a complete list of possible side effects. If you||
1910|111|S|notice other effects not listed above, contact your doctor or||
1910|112|S|pharmacist.||
1910|113|S|   In the US -||
1910|114|S|   Call your doctor for medical advice about side effects. You||
1910|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1910|116|S|www.fda.gov/medwatch.||
1910|117|S|   In Canada - Call your doctor for medical advice about side||
1910|118|S|effects. You may report side effects to Health Canada at||
1910|119|S|1-866-234-2345.||
1910|120|B|||
1910|121|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1910|122|P|pharmacist if you are allergic to bictegravir, emtricitabine, or||
1910|123|P|tenofovir; or if you have any other allergies. This product may||
1910|124|P|contain inactive ingredients, which can cause allergic reactions||
1910|125|P|or other problems. Talk to your pharmacist for more details.||
1910|126|P|   Before using this medication, tell your doctor or pharmacist||
1910|127|P|your medical history, especially of: liver problems (hepatitis B,||
1910|128|P|hepatitis C, cirrhosis), alcohol use, kidney disease.||
1910|129|P|   Before having surgery, tell your doctor or dentist about all||
1910|130|P|the products you use (including prescription drugs,||
1910|131|P|nonprescription drugs, and herbal products).||
1910|132|P|   Tell your doctor if you are pregnant before using this||
1910|133|P|medication. Treatment can lower the risk of passing HIV infection||
1910|134|P|to your baby. Discuss the risks and benefits with your doctor.||
1910|135|P|   This medication passes into breast milk. Because breast milk||
1910|136|P|may transmit HIV, consult your doctor before breastfeeding.||
1910|137|B|||
1910|138|I|DRUG INTERACTIONS:  See also How to Use section.||
1910|139|I|   Drug interactions may change how your medications work or||
1910|140|I|increase your risk for serious side effects. This document does||
1910|141|I|not contain all possible drug interactions. Keep a list of all||
1910|142|I|the products you use (including prescription/nonprescription||
1910|143|I|drugs and herbal products) and share it with your doctor and||
1910|144|I|pharmacist. Do not start, stop, or change the dosage of any||
1910|145|I|medicines without your doctor's approval.||
1910|146|I|   Some products that may interact with this drug are: orlistat,||
1910|147|I|other drugs that may harm the kidneys (including adefovir,||
1910|148|I|cidofovir, aminoglycosides such as amikacin/gentamicin).||
1910|149|I|   Other medications can affect the removal of this medication||
1910|150|I|from your body, which may affect how it works. Examples include||
1910|151|I|rifamycins (such as rifampin, rifabutin), St. John's wort, drugs||
1910|152|I|used to treat seizures (such as barbiturates, carbamazepine,||
1910|153|I|phenytoin), among others.||
1910|154|I|   This medication can slow down the removal of other medications||
1910|155|I|from your body, which may affect how they work. Examples of||
1910|156|I|affected drugs include dofetilide, among others.||
1910|157|I|   Do not take this medication with other products that treat HIV||
1910|158|I|infection. Do not take this medication with other products that||
1910|159|I|contain bictegravir, emtricitabine, or tenofovir.||
1910|160|B|||
1910|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1910|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1910|163|O|poison control center right away. US residents can call||
1910|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1910|165|B|||
1910|166|N|NOTES:  Do not share this medication with others.||
1910|167|N|   Lab and/or medical tests (such as kidney/liver function, viral||
1910|168|N|load, T-cell counts, tests for hepatitis B) should be done before||
1910|169|N|you start taking this medication and while you are taking it.||
1910|170|N|Keep all medical and lab appointments.||
1910|171|B|||
1910|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1910|173|D|remember. If it is near the time of the next dose, skip the||
1910|174|D|missed dose. Take your next dose at the regular time. Do not||
1910|175|D|double the dose to catch up.||
1910|176|B|||
1910|177|R|STORAGE:  Store in the original container at room temperature||
1910|178|R|away from light and moisture. Do not store in the bathroom. Keep||
1910|179|R|the drying agent (desiccant) in the bottle. Tightly close the||
1910|180|R|bottle when not in use. Keep all medications away from children||
1910|181|R|and pets.||
1910|182|R|   Do not flush medications down the toilet or pour them into a||
1910|183|R|drain unless instructed to do so. Properly discard this product||
1910|184|R|when it is expired or no longer needed. Consult your pharmacist||
1910|185|R|or local waste disposal company.||
1910|186|B|||
1910|187|A|Information last revised April 2025.||
1910|188|A|Copyright(c) 2025 First Databank, Inc.||
1910|189|B|||
1911|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1911|002|Z|does NOT have all possible information about this product. This||
1911|003|Z|information does not assure that this product is safe, effective,||
1911|004|Z|or appropriate for you. This information is not individual||
1911|005|Z|medical advice and does not substitute for the advice of your||
1911|006|Z|health care professional. Always ask your health care||
1911|007|Z|professional for complete information about this product and your||
1911|008|Z|specific health needs.||
1911|009|B|||
1911|010|T|TEZACAFTOR/IVACAFTOR AND IVACAFTOR - ORAL||
1911|011|F|(TEZ-a-KAF-tor/EYE-va-KAF-tor and EYE-va-KAF-tor)||
1911|012|B|||
1911|013|C|COMMON BRAND NAME(S): Symdeko||
1911|014|B|||
1911|015|U|USES:  This product contains 2 different tablets. One tablet||
1911|016|U|contains 2 medications ("multi-drug"): tezacaftor and ivacaftor.||
1911|017|U|The other tablet contains only ivacaftor.||
1911|018|U|   This product is used to treat cystic fibrosis in certain||
1911|019|U|people (those with an abnormal "CFTR" gene). It may help to||
1911|020|U|improve breathing, reduce the risk of lung infections, and||
1911|021|U|improve weight gain.||
1911|022|B|||
1911|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1911|024|H|from your pharmacist before you start taking this product and||
1911|025|H|each time you get a refill. If you have any questions, ask your||
1911|026|H|doctor or pharmacist.||
1911|027|H|   Take the multi-drug tablet by mouth in the morning and take||
1911|028|H|ivacaftor tablet by mouth in the evening as directed by your||
1911|029|H|doctor, usually 12 hours apart. Take both tablets with food that||
1911|030|H|has fat (such as eggs, avocados, cheese, nuts, butter, peanut||
1911|031|H|butter).||
1911|032|H|   The dosage is based on your medical condition, age, response||
1911|033|H|to treatment, and other medications you may be taking. Children's||
1911|034|H|dosage is also based on weight. Be sure to tell your doctor and||
1911|035|H|pharmacist about all the products you use (including prescription||
1911|036|H|drugs, nonprescription drugs, and herbal products).||
1911|037|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1911|038|H|using this medication unless your doctor or pharmacist says you||
1911|039|H|may do so safely. Grapefruit can increase the chance of side||
1911|040|H|effects with this medicine. Ask your doctor or pharmacist for||
1911|041|H|more details.||
1911|042|H|   Use this product regularly to get the most benefit from it. To||
1911|043|H|help you remember, take it at the same times each day.||
1911|044|H|   Tell your doctor if your condition does not get better or if||
1911|045|H|it gets worse.||
1911|046|B|||
1911|047|S|SIDE EFFECTS:  Nausea, headache, or dizziness may occur. If any||
1911|048|S|of these effects last or get worse, tell your doctor or||
1911|049|S|pharmacist promptly.||
1911|050|S|   Remember that this product has been prescribed because your||
1911|051|S|doctor has judged that the benefit to you is greater than the||
1911|052|S|risk of side effects. Many people using this product do not have||
1911|053|S|serious side effects.||
1911|054|S|   This medication may rarely cause increased pressure around the||
1911|055|S|brain (intracranial hypertension-IH). Get medical help right away||
1911|056|S|if any of these very serious side effects occur: headache that is||
1911|057|S|severe or doesn't go away, vision changes (such as blurred/double||
1911|058|S|vision, decreased vision).||
1911|059|S|   This product may rarely cause serious liver disease. Get||
1911|060|S|medical help right away if you have any symptoms of liver damage,||
1911|061|S|such as: nausea/vomiting that doesn't stop, loss of appetite,||
1911|062|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
1911|063|S|   A very serious allergic reaction to this drug is rare.||
1911|064|S|However, get medical help right away if you notice any symptoms||
1911|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1911|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1911|067|S|breathing.||
1911|068|S|   This is not a complete list of possible side effects. If you||
1911|069|S|notice other effects not listed above, contact your doctor or||
1911|070|S|pharmacist.||
1911|071|S|   In the US -||
1911|072|S|   Call your doctor for medical advice about side effects. You||
1911|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1911|074|S|www.fda.gov/medwatch.||
1911|075|S|   In Canada - Call your doctor for medical advice about side||
1911|076|S|effects. You may report side effects to Health Canada at||
1911|077|S|1-866-234-2345.||
1911|078|B|||
1911|079|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1911|080|P|pharmacist if you are allergic to tezacaftor or ivacaftor; or if||
1911|081|P|you have any other allergies. This product may contain inactive||
1911|082|P|ingredients, which can cause allergic reactions or other||
1911|083|P|problems. Talk to your pharmacist for more details.||
1911|084|P|   Before using this product, tell your doctor or pharmacist your||
1911|085|P|medical history, especially of: liver disease, kidney disease.||
1911|086|P|   This product may make you dizzy. Alcohol or marijuana||
1911|087|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
1911|088|P|or do anything that needs alertness until you can do it safely.||
1911|089|P|Limit alcoholic beverages. Talk to your doctor if you are using||
1911|090|P|marijuana (cannabis).||
1911|091|P|   Before having surgery, tell your doctor or dentist about all||
1911|092|P|the products you use (including prescription drugs,||
1911|093|P|nonprescription drugs, and herbal products).||
1911|094|P|   During pregnancy, this product should be used only when||
1911|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1911|096|P|   This product passes into breast milk. Consult your doctor||
1911|097|P|before breastfeeding.||
1911|098|B|||
1911|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1911|100|I|medications work or increase your risk for serious side effects.||
1911|101|I|This document does not contain all possible drug interactions.||
1911|102|I|Keep a list of all the products you use (including||
1911|103|I|prescription/nonprescription drugs and herbal products) and share||
1911|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1911|105|I|the dosage of any medicines without your doctor's approval.||
1911|106|I|   Other medications can affect the removal of||
1911|107|I|tezacaftor/ivacaftor from your body, which may affect how this||
1911|108|I|product works. Examples include mifepristone, rifamycins (such as||
1911|109|I|rifampin, rifabutin), drugs for seizures (such as carbamazepine,||
1911|110|I|phenytoin), St. John's wort, among others.||
1911|111|B|||
1911|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1911|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1911|114|O|poison control center right away. US residents can call||
1911|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1911|116|B|||
1911|117|N|NOTES:  Do not share this product with others.||
1911|118|N|   Lab and/or medical tests (such as CFTR gene testing,||
1911|119|N|liver/lung function, eye exams) will be done before you start||
1911|120|N|taking this product and while you are taking it. Keep all medical||
1911|121|N|and lab appointments.||
1911|122|B|||
1911|123|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1911|124|D|remember. If it is more than 6 hours after the missed dose, skip||
1911|125|D|the missed dose. Take your next dose at the regular time. Do not||
1911|126|D|double the dose to catch up.||
1911|127|B|||
1911|128|R|STORAGE:  Store at room temperature away from light and moisture.||
1911|129|R|Do not store in the bathroom. Keep all medications away from||
1911|130|R|children and pets.||
1911|131|R|   Do not flush medications down the toilet or pour them into a||
1911|132|R|drain unless instructed to do so. Properly discard this product||
1911|133|R|when it is expired or no longer needed. Consult your pharmacist||
1911|134|R|or local waste disposal company.||
1911|135|B|||
1911|136|A|Information last revised September 2025.||
1911|137|A|Copyright(c) 2025 First Databank, Inc.||
1911|138|B|||
1912|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1912|002|Z|does NOT have all possible information about this product. This||
1912|003|Z|information does not assure that this product is safe, effective,||
1912|004|Z|or appropriate for you. This information is not individual||
1912|005|Z|medical advice and does not substitute for the advice of your||
1912|006|Z|health care professional. Always ask your health care||
1912|007|Z|professional for complete information about this product and your||
1912|008|Z|specific health needs.||
1912|009|B|||
1912|010|T|APALUTAMIDE - ORAL||
1912|011|F|(A-puh-LOO-tuh-mide)||
1912|012|B|||
1912|013|C|COMMON BRAND NAME(S): Erleada||
1912|014|B|||
1912|015|U|USES:  Apalutamide is used to treat men with prostate cancer.||
1912|016|U|This medication belongs to a class of drugs known as||
1912|017|U|anti-androgens (anti-testosterone). It works by blocking the||
1912|018|U|effects of testosterone to slow the growth and spread of prostate||
1912|019|U|cancer.||
1912|020|B|||
1912|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
1912|022|H|Instructions for Use if available from your pharmacist before you||
1912|023|H|start taking apalutamide and each time you get a refill. If you||
1912|024|H|have any questions, ask your doctor or pharmacist.||
1912|025|H|   Take this medication by mouth with or without food as directed||
1912|026|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
1912|027|H|not cut, chew, or crush the tablets.||
1912|028|H|   If you are using the 60 milligram tablets and have difficulty||
1912|029|H|swallowing the tablets whole, ask your doctor or pharmacist for||
1912|030|H|detailed instructions on how to properly mix the tablets and take||
1912|031|H|the mixture.||
1912|032|H|   If you are using the 240 milligram tablet and have difficulty||
1912|033|H|swallowing the tablet whole, you may mix the whole tablet with||
1912|034|H|water as directed. Add 2 teaspoons (10 milliliters) of water to a||
1912|035|H|cup with the tablet inside. Do not split or crush the tablet.||
1912|036|H|Make sure that the tablet is covered with water. Wait 2 minutes||
1912|037|H|for the tablet to break up and then stir the mixture. Then add 2||
1912|038|H|tablespoons (30 milliliters) of either orange juice, applesauce,||
1912|039|H|or more water to the mixture and stir. Swallow the mixture right||
1912|040|H|away. After taking the mixture, rinse the cup with water and||
1912|041|H|drink the water to make sure you take the full dose of the||
1912|042|H|medication. Do not save any of the mixture for future use.||
1912|043|H|   If you are giving this medication through a feeding tube, ask||
1912|044|H|your health care professional for detailed instructions on how to||
1912|045|H|properly mix and give it.||
1912|046|H|   The dosage is based on your medical condition and response to||
1912|047|H|treatment. Do not increase your dose or take this drug more often||
1912|048|H|than prescribed. Your condition will not improve any faster, and||
1912|049|H|your risk of side effects will increase.||
1912|050|H|   Take this medication regularly to get the most benefit from||
1912|051|H|it. To help you remember, take it at the same time each day.||
1912|052|H|   Since this drug can be absorbed through the skin and lungs and||
1912|053|H|may harm an unborn baby, women who are pregnant or who may become||
1912|054|H|pregnant should not handle this medication or breathe the dust||
1912|055|H|from the tablets.||
1912|056|B|||
1912|057|S|SIDE EFFECTS:  Hot flashes, tiredness, joint pain, nausea,||
1912|058|S|decreased appetite, weight loss, or decreased sexual||
1912|059|S|interest/ability may occur. If any of these effects last or get||
1912|060|S|worse, tell your doctor or pharmacist promptly.||
1912|061|S|   Remember that this medication has been prescribed because your||
1912|062|S|doctor has judged that the benefit to you is greater than the||
1912|063|S|risk of side effects. Many people using this medication do not||
1912|064|S|have serious side effects.||
1912|065|S|   This medication may raise your blood pressure. Check your||
1912|066|S|blood pressure regularly and tell your doctor if the results are||
1912|067|S|high.||
1912|068|S|   Tell your doctor right away if you have any serious side||
1912|069|S|effects, including: signs of an underactive thyroid (such as||
1912|070|S|unusual weight gain, cold intolerance, slow heartbeat,||
1912|071|S|constipation).||
1912|072|S|   Treatment with this medication can cause bones and muscles to||
1912|073|S|weaken, which may increase your risk for falls and broken bones.||
1912|074|S|Ask your doctor for details.||
1912|075|S|   This medication may lower your ability to fight infections.||
1912|076|S|This may make you more likely to get a serious (rarely fatal)||
1912|077|S|infection or make any infection you have worse. Get medical help||
1912|078|S|right away if you have any signs of infection (such as sore||
1912|079|S|throat that doesn't go away, fever, swollen lymph nodes, chills).||
1912|080|S|   Rarely, apalutamide has caused severe (sometimes fatal) lung||
1912|081|S|problems (interstitial pneumonitis). Get medical help right away||
1912|082|S|if you develop symptoms of lung problems (such as cough, fever).||
1912|083|S|   Get medical help right away if you have any very serious side||
1912|084|S|effects, including: symptoms of a heart attack (such as||
1912|085|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
1912|086|S|signs of a stroke (such as weakness on one side of the body,||
1912|087|S|trouble speaking, sudden vision changes, confusion), seizure.||
1912|088|S|   A very serious allergic reaction to this drug is rare.||
1912|089|S|However, get medical help right away if you notice any symptoms||
1912|090|S|of a serious allergic reaction, including: rash, itching/swelling||
1912|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1912|092|S|breathing.||
1912|093|S|   Apalutamide can commonly cause a mild rash that is usually not||
1912|094|S|serious. However, you may not be able to tell it apart from a||
1912|095|S|rare rash that could be a sign of a severe reaction. Get medical||
1912|096|S|help right away if you develop any rash.||
1912|097|S|   This is not a complete list of possible side effects. If you||
1912|098|S|notice other effects not listed above, contact your doctor or||
1912|099|S|pharmacist.||
1912|100|S|   In the US -||
1912|101|S|   Call your doctor for medical advice about side effects. You||
1912|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1912|103|S|www.fda.gov/medwatch.||
1912|104|S|   In Canada - Call your doctor for medical advice about side||
1912|105|S|effects. You may report side effects to Health Canada at||
1912|106|S|1-866-234-2345.||
1912|107|B|||
1912|108|P|PRECAUTIONS:  Before taking apalutamide, tell your doctor or||
1912|109|P|pharmacist if you are allergic to it; or if you have any other||
1912|110|P|allergies. This product may contain inactive ingredients, which||
1912|111|P|can cause allergic reactions or other problems. Talk to your||
1912|112|P|pharmacist for more details.||
1912|113|P|   Before using this medication, tell your doctor or pharmacist||
1912|114|P|your medical history, especially of: heart problems (such as||
1912|115|P|coronary artery disease, heart failure, recent heart attack),||
1912|116|P|diabetes, high cholesterol, high blood pressure, stroke/transient||
1912|117|P|ischemic attack (TIA), seizure, increased risk for seizure (such||
1912|118|P|as brain injury, stroke, brain tumor).||
1912|119|P|   Since this medication may rarely cause seizures in some||
1912|120|P|people, ask your doctor if you should avoid activities where a||
1912|121|P|sudden loss of consciousness may cause serious harm to you or||
1912|122|P|others.||
1912|123|P|   Before having surgery, tell your doctor or dentist about all||
1912|124|P|the products you use (including prescription drugs,||
1912|125|P|nonprescription drugs, and herbal products).||
1912|126|P|   This medication should not be used by women, especially during||
1912|127|P|pregnancy or breastfeeding. It may harm an unborn or||
1912|128|P|breastfeeding baby. Consult your doctor for more details.||
1912|129|P|   Older adults may be at greater risk for falls while using this||
1912|130|P|drug.||
1912|131|P|   Men who are sexually active with a pregnant woman must use a||
1912|132|P|condom during treatment and for 3 months after stopping||
1912|133|P|treatment. Men with female partners of childbearing age should||
1912|134|P|use reliable forms of birth control during treatment and for 3||
1912|135|P|months after stopping treatment. If your partner becomes pregnant||
1912|136|P|or thinks she may be pregnant, tell the doctor right away. Do not||
1912|137|P|donate sperm during treatment and for at least 3 months after||
1912|138|P|stopping treatment.||
1912|139|B|||
1912|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1912|141|I|medications work or increase your risk for serious side effects.||
1912|142|I|This document does not contain all possible drug interactions.||
1912|143|I|Keep a list of all the products you use (including||
1912|144|I|prescription/nonprescription drugs and herbal products) and share||
1912|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
1912|146|I|the dosage of any medicines without your doctor's approval.||
1912|147|I|   Apalutamide can speed up the removal of other medications from||
1912|148|I|your body, which may affect how they work. Examples of affected||
1912|149|I|drugs include artemether-lumefantrine, azole antifungals (such as||
1912|150|I|isavuconazonium, voriconazole), cobicistat, dabigatran,||
1912|151|I|lurasidone, nifedipine, ranolazine, rilpivirine, certain drugs||
1912|152|I|for hepatitis C (such as ledipasvir, sofosbuvir), among others.||
1912|153|B|||
1912|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1912|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1912|156|O|poison control center right away. US residents can call||
1912|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1912|158|B|||
1912|159|N|NOTES:  Do not share this medication with others.||
1912|160|N|   Lab and/or medical tests (such as blood pressure, thyroid||
1912|161|N|function) should be done while you are taking this medication.||
1912|162|N|Keep all medical and lab appointments.||
1912|163|B|||
1912|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1912|165|D|remember. If it is near the time of the next dose, skip the||
1912|166|D|missed dose. Take your next dose at the regular time. Do not||
1912|167|D|double the dose to catch up.||
1912|168|B|||
1912|169|R|STORAGE:  Store in the original package at room temperature away||
1912|170|R|from light and moisture. Do not store in the bathroom. Keep the||
1912|171|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1912|172|R|when not in use. Keep all medications away from children and||
1912|173|R|pets.||
1912|174|R|   Do not flush medications down the toilet or pour them into a||
1912|175|R|drain unless instructed to do so. Properly discard this product||
1912|176|R|when it is expired or no longer needed. Consult your pharmacist||
1912|177|R|or local waste disposal company.||
1912|178|B|||
1912|179|A|Information last revised November 2025.||
1912|180|A|Copyright(c) 2025 First Databank, Inc.||
1912|181|B|||
1914|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1914|002|Z|does NOT have all possible information about this product. This||
1914|003|Z|information does not assure that this product is safe, effective,||
1914|004|Z|or appropriate for you. This information is not individual||
1914|005|Z|medical advice and does not substitute for the advice of your||
1914|006|Z|health care professional. Always ask your health care||
1914|007|Z|professional for complete information about this product and your||
1914|008|Z|specific health needs.||
1914|009|B|||
1914|010|T|DOXYLAMINE/PYRIDOXINE EXTENDED-RELEASE - ORAL||
1914|011|F|(dox-IL-a-meen/PIR-i-DOX-een)||
1914|012|B|||
1914|013|C|COMMON BRAND NAME(S): Bonjesta||
1914|014|B|||
1914|015|U|USES:  This combination medication contains 2 ingredients:||
1914|016|U|doxylamine and pyridoxine. It is used to prevent or reduce nausea||
1914|017|U|and vomiting caused by pregnancy. Decreasing nausea and vomiting||
1914|018|U|may improve your health and nutrition during pregnancy.||
1914|019|U|Doxylamine is an antihistamine that is thought to work by||
1914|020|U|affecting certain natural substances (acetylcholine, serotonin)||
1914|021|U|in your body or by acting directly on certain parts of the brain.||
1914|022|U|Pyridoxine is a B vitamin that is important for good health. Most||
1914|023|U|people get enough pyridoxine in their diet, but certain health||
1914|024|U|conditions (such as pregnancy, poor diet, alcoholism) can result||
1914|025|U|in a lack of this vitamin.||
1914|026|B|||
1914|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1914|028|H|from your pharmacist before you start taking this medication and||
1914|029|H|each time you get a refill. If you have any questions, ask your||
1914|030|H|doctor or pharmacist.||
1914|031|H|   Take this medication by mouth on an empty stomach with a glass||
1914|032|H|of water as directed by your doctor, usually starting with once||
1914|033|H|daily at bedtime. If your nausea lasts on the next day, your||
1914|034|H|doctor may direct you to increase your dose to twice daily (in||
1914|035|H|the morning and at bedtime). Do not take more than 2 tablets in a||
1914|036|H|day.||
1914|037|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
1914|038|H|Doing so can release all of the drug at once, increasing the risk||
1914|039|H|of side effects.||
1914|040|H|   Do not stop using this medication or change your dose without||
1914|041|H|consulting your doctor. Some conditions may become worse when||
1914|042|H|this drug is suddenly stopped. Your dose may need to be gradually||
1914|043|H|decreased.||
1914|044|H|   Use this medication regularly to get the most benefit from it.||
1914|045|H|To help you remember, take it at the same times each day.||
1914|046|B|||
1914|047|S|SIDE EFFECTS:  Drowsiness, dizziness, or blurred vision may||
1914|048|S|occur. If any of these effects last or get worse, tell your||
1914|049|S|doctor or pharmacist promptly.||
1914|050|S|   Remember that this medication has been prescribed because your||
1914|051|S|doctor has judged that the benefit to you is greater than the||
1914|052|S|risk of side effects. Many people using this medication do not||
1914|053|S|have serious side effects.||
1914|054|S|   Tell your doctor right away if you have any serious side||
1914|055|S|effects, including: mental/mood changes (such as confusion,||
1914|056|S|irritability, nervousness), trouble urinating.||
1914|057|S|   A very serious allergic reaction to this drug is rare.||
1914|058|S|However, get medical help right away if you notice any symptoms||
1914|059|S|of a serious allergic reaction, including: rash, itching/swelling||
1914|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1914|061|S|breathing.||
1914|062|S|   This is not a complete list of possible side effects. If you||
1914|063|S|notice other effects not listed above, contact your doctor or||
1914|064|S|pharmacist.||
1914|065|S|   In the US -||
1914|066|S|   Call your doctor for medical advice about side effects. You||
1914|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1914|068|S|www.fda.gov/medwatch.||
1914|069|S|   In Canada - Call your doctor for medical advice about side||
1914|070|S|effects. You may report side effects to Health Canada at||
1914|071|S|1-866-234-2345.||
1914|072|B|||
1914|073|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
1914|074|P|pharmacist if you are allergic to doxylamine or pyridoxine; or if||
1914|075|P|you have any other allergies. This product may contain inactive||
1914|076|P|ingredients, which can cause allergic reactions or other||
1914|077|P|problems. Talk to your pharmacist for more details.||
1914|078|P|   Before using this medication, tell your doctor or pharmacist||
1914|079|P|your medical history, especially of: breathing problems (such as||
1914|080|P|asthma, emphysema), eye problems (such as glaucoma), stomach||
1914|081|P|problems (such as ulcers, blockage), urination problems (such as||
1914|082|P|urinary retention).||
1914|083|P|   This drug may make you dizzy or drowsy or cause blurred||
1914|084|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
1914|085|P|or drowsy. Do not drive, use machinery, or do anything that needs||
1914|086|P|alertness or clear vision until you can do it safely. Avoid||
1914|087|P|alcoholic beverages. Talk to your doctor if you are using||
1914|088|P|marijuana (cannabis).||
1914|089|P|   Before having surgery, tell your doctor or dentist about all||
1914|090|P|the products you use (including prescription drugs,||
1914|091|P|nonprescription drugs, and herbal products).||
1914|092|P|   This product is safe to use during pregnancy.||
1914|093|P|   Pyridoxine passes into breast milk. It is unknown if||
1914|094|P|doxylamine passes into breast milk. However, similar drugs pass||
1914|095|P|into breast milk. Doxylamine may have undesirable effects on a||
1914|096|P|nursing infant. Consult your doctor before breastfeeding.||
1914|097|B|||
1914|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1914|099|I|medications work or increase your risk for serious side effects.||
1914|100|I|This document does not contain all possible drug interactions.||
1914|101|I|Keep a list of all the products you use (including||
1914|102|I|prescription/nonprescription drugs and herbal products) and share||
1914|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
1914|104|I|the dosage of any medicines without your doctor's approval.||
1914|105|I|   Some products that may interact with this drug are:||
1914|106|I|altretamine, antihistamines applied to the skin (such as||
1914|107|I|diphenhydramine cream, ointment, spray).||
1914|108|I|   Tell your doctor or pharmacist if you are taking other||
1914|109|I|products that cause drowsiness such as opioid pain or cough||
1914|110|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1914|111|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1914|112|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1914|113|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
1914|114|I|diphenhydramine).||
1914|115|I|   Check the labels on all your medicines (such as allergy or||
1914|116|I|cough-and-cold products) because they may contain ingredients||
1914|117|I|that cause drowsiness. Ask your pharmacist about using those||
1914|118|I|products safely.||
1914|119|I|   This medication may interfere with certain lab tests (such as||
1914|120|I|urine drug screening tests), possibly causing false test results.||
1914|121|I|Make sure lab personnel and all your doctors know you use this||
1914|122|I|drug.||
1914|123|B|||
1914|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1914|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1914|126|O|poison control center right away. US residents can call||
1914|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1914|128|O|Symptoms of overdose may include: restlessness, dry mouth, severe||
1914|129|O|drowsiness, confusion, fast heartbeat, weakness, seizure.||
1914|130|B|||
1914|131|N|NOTES:  Do not share this medication with others.||
1914|132|N|   Do not take for several days before allergy testing because||
1914|133|N|test results can be affected.||
1914|134|B|||
1914|135|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1914|136|D|remember. If it is near the time of the next dose, skip the||
1914|137|D|missed dose. Take your next dose at the regular time. Do not||
1914|138|D|double the dose to catch up.||
1914|139|B|||
1914|140|R|STORAGE:  Store at room temperature away from light and moisture.||
1914|141|R|Do not store in the bathroom. Keep all medications away from||
1914|142|R|children and pets.||
1914|143|R|   Do not flush medications down the toilet or pour them into a||
1914|144|R|drain unless instructed to do so. Properly discard this product||
1914|145|R|when it is expired or no longer needed. Consult your pharmacist||
1914|146|R|or local waste disposal company.||
1914|147|B|||
1914|148|A|Information last revised May 2024.||
1914|149|A|Copyright(c) 2025 First Databank, Inc.||
1914|150|B|||
1915|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1915|002|Z|does NOT have all possible information about this product. This||
1915|003|Z|information does not assure that this product is safe, effective,||
1915|004|Z|or appropriate for you. This information is not individual||
1915|005|Z|medical advice and does not substitute for the advice of your||
1915|006|Z|health care professional. Always ask your health care||
1915|007|Z|professional for complete information about this product and your||
1915|008|Z|specific health needs.||
1915|009|B|||
1915|010|T|EFAVIRENZ/LAMIVUDINE/TENOFOVIR - ORAL||
1915|011|F|(EF-a-VIR-enz/la-MIV-ue-deen/ten-OF-oh-vir)||
1915|012|B|||
1915|013|C|COMMON BRAND NAME(S): Symfi, Symfi Lo||
1915|014|B|||
1915|015|W|WARNING:  If you have hepatitis B infection as well as HIV, your||
1915|016|W|hepatitis symptoms may get worse or become very serious if you||
1915|017|W|stop taking this medication. Talk with your doctor before||
1915|018|W|stopping this medication. Your doctor will check your liver||
1915|019|W|function tests for several months after you stop. Tell your||
1915|020|W|doctor right away if you develop symptoms of worsening liver||
1915|021|W|problems.||
1915|022|B|||
1915|023|U|USES:  This combination product is used by itself to help control||
1915|024|U|HIV infection. It helps to decrease the amount of HIV in your||
1915|025|U|body so your immune system can work better. This lowers your||
1915|026|U|chance of getting HIV complications (such as new infections,||
1915|027|U|cancer) and improves your quality of life. This product is a||
1915|028|U|combination of 3 different drugs: efavirenz, lamivudine, and||
1915|029|U|tenofovir. Efavirenz belongs to a class of drugs known as||
1915|030|U|non-nucleoside reverse transcriptase inhibitors (NNRTIs).||
1915|031|U|Lamivudine is called a nucleoside reverse transcriptase inhibitor||
1915|032|U|and tenofovir is called a nucleotide reverse transcriptase||
1915|033|U|inhibitor. Lamivudine and tenofovir are often called NRTIs.||
1915|034|U|   Efavirenz/lamivudine/tenofovir is not a cure for HIV||
1915|035|U|infection. To decrease your risk of spreading HIV disease to||
1915|036|U|others, continue to take all HIV medications exactly as||
1915|037|U|prescribed by your doctor. Use an effective barrier method (latex||
1915|038|U|or polyurethane condoms/dental dams) during sexual activity as||
1915|039|U|directed by your doctor. Do not share personal items (such as||
1915|040|U|needles/syringes, toothbrushes, and razors) that may have||
1915|041|U|contacted blood or other body fluids. Consult your doctor or||
1915|042|U|pharmacist for more details.||
1915|043|B|||
1915|044|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1915|045|H|from your pharmacist before you start taking||
1915|046|H|efavirenz/lamivudine/tenofovir and each time you get a refill. If||
1915|047|H|you have any questions, ask your doctor or pharmacist.||
1915|048|H|   Take this medication by mouth as directed by your doctor,||
1915|049|H|usually once daily at bedtime on an empty stomach. Taking this||
1915|050|H|medication at bedtime may help decrease some side effects.||
1915|051|H|   It is very important to keep taking this medication exactly as||
1915|052|H|prescribed by your doctor. Do not skip any doses.||
1915|053|H|   For the best effect, take this medication at evenly spaced||
1915|054|H|times. To help you remember, take this medication at the same||
1915|055|H|time every day.||
1915|056|H|   Do not take more or less of this drug than prescribed or stop||
1915|057|H|taking it even for a short time unless directed to do so by your||
1915|058|H|doctor. Doing so may cause the amount of virus to increase, make||
1915|059|H|the infection more difficult to treat (resistant), or worsen side||
1915|060|H|effects.||
1915|061|B|||
1915|062|S|SIDE EFFECTS:  Dizziness, trouble sleeping, drowsiness, unusual||
1915|063|S|dreams, and trouble concentrating may commonly occur. These side||
1915|064|S|effects may begin 1 or 2 days after starting this medication, but||
1915|065|S|usually get better within 2 to 4 weeks. Taking this medication at||
1915|066|S|bedtime may help.||
1915|067|S|   Tiredness, headache, and diarrhea may also occur.||
1915|068|S|   If any of these effects last or get worse, tell your doctor or||
1915|069|S|pharmacist promptly.||
1915|070|S|   Remember that this medication has been prescribed because your||
1915|071|S|doctor has judged that the benefit to you is greater than the||
1915|072|S|risk of side effects. Many people using this medication do not||
1915|073|S|have serious side effects.||
1915|074|S|   As your immune system gets stronger, it can begin to fight off||
1915|075|S|infections you already had, possibly causing disease symptoms to||
1915|076|S|come back. You could also have symptoms if your immune system||
1915|077|S|becomes overactive. This reaction may happen at any time (soon||
1915|078|S|after starting HIV treatment or many months later). Tell your||
1915|079|S|doctor right away if you have any serious symptoms, including:||
1915|080|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1915|081|S|that doesn't go away, headaches that are severe or don't go away,||
1915|082|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1915|083|S|changes, signs of infection (such as sore throat that doesn't go||
1915|084|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1915|085|S|sores), signs of an overactive thyroid (such as irritability,||
1915|086|S|nervousness, heat intolerance, fast/pounding/irregular||
1915|087|S|heartbeat).||
1915|088|S|   Tell your doctor right away if you have any serious side||
1915|089|S|effects, including: mental/mood changes (such as depression, rare||
1915|090|S|thoughts of suicide, strange thoughts, anxiety, angry behavior,||
1915|091|S|hallucinations, confusion), loss of coordination, signs of kidney||
1915|092|S|problems (such as a change in the amount of urine), signs of a||
1915|093|S|buildup of lactic acid in the blood (such as unusual tiredness,||
1915|094|S|dizziness, severe drowsiness, chills, blue/cold skin, muscle||
1915|095|S|pain, fast/difficult breathing, slow/irregular heartbeat, or||
1915|096|S|stomach pain with nausea/vomiting/diarrhea), signs of liver||
1915|097|S|problems (such as nausea/vomiting that doesn't stop, loss of||
1915|098|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1915|099|S|urine), signs of pancreatitis (such as nausea, vomiting,||
1915|100|S|stomach/abdominal/back pain, fever).||
1915|101|S|   Changes in body fat may occur while you are taking this||
1915|102|S|medication (such as increased fat in the upper back and stomach||
1915|103|S|areas, decreased fat in the arms and legs). The cause and||
1915|104|S|long-term effects of these changes are unknown. Discuss the risks||
1915|105|S|and benefits of treatment with your doctor, as well as the||
1915|106|S|possible use of exercise to reduce this side effect.||
1915|107|S|   Tenofovir may increase the risk of bone loss. Discuss the||
1915|108|S|risks and benefits of treatment with your doctor, as well as the||
1915|109|S|possible use of calcium and vitamin D to reduce this side effect.||
1915|110|S|If you are at risk for bone loss, your doctor may monitor your||
1915|111|S|bone mineral density. Tell your doctor right away if any of the||
1915|112|S|following serious side effects occur: bone pain, easily broken||
1915|113|S|bones.||
1915|114|S|   Get medical help right away if you have any very serious side||
1915|115|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1915|116|S|fainting, seizure.||
1915|117|S|   Efavirenz/lamivudine/tenofovir can commonly cause a rash that||
1915|118|S|is usually not serious. However, you may not be able to tell it||
1915|119|S|apart from a rare rash that could be a sign of a severe reaction.||
1915|120|S|Tell your doctor right away if you develop any rash.||
1915|121|S|   A very serious allergic reaction to this drug is rare.||
1915|122|S|However, get medical help right away if you notice any symptoms||
1915|123|S|of a serious allergic reaction, including: rash, blisters,||
1915|124|S|peeling skin, itching/swelling (especially of the||
1915|125|S|face/tongue/throat), severe dizziness, trouble breathing.||
1915|126|S|   This is not a complete list of possible side effects. If you||
1915|127|S|notice other effects not listed above, contact your doctor or||
1915|128|S|pharmacist.||
1915|129|S|   In the US -||
1915|130|S|   Call your doctor for medical advice about side effects. You||
1915|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1915|132|S|www.fda.gov/medwatch.||
1915|133|S|   In Canada - Call your doctor for medical advice about side||
1915|134|S|effects. You may report side effects to Health Canada at||
1915|135|S|1-866-234-2345.||
1915|136|B|||
1915|137|P|PRECAUTIONS:  Before taking efavirenz/lamivudine/tenofovir, tell||
1915|138|P|your doctor or pharmacist if you are allergic to any of the||
1915|139|P|ingredients; or if you have any other allergies. This product may||
1915|140|P|contain inactive ingredients, which can cause allergic reactions||
1915|141|P|or other problems. Talk to your pharmacist for more details.||
1915|142|P|   Before using this medication, tell your doctor or pharmacist||
1915|143|P|your medical history, especially of: kidney problems, liver||
1915|144|P|problems (such as hepatitis B or C, cirrhosis), mental/mood||
1915|145|P|conditions (such as depression, thoughts of suicide, psychosis),||
1915|146|P|high cholesterol/triglyceride levels, bone problems (such as bone||
1915|147|P|disease, bone loss/osteoporosis, weak/broken bones), disease of||
1915|148|P|the pancreas (pancreatitis), seizures, substance use disorder||
1915|149|P|(such as overuse of or addiction to drugs/alcohol).||
1915|150|P|   Efavirenz/lamivudine/tenofovir may cause a condition that||
1915|151|P|affects the heart rhythm (QT prolongation). QT prolongation can||
1915|152|P|rarely cause serious (rarely fatal) fast/irregular heartbeat and||
1915|153|P|other symptoms (such as severe dizziness, fainting) that need||
1915|154|P|medical attention right away.||
1915|155|P|   The risk of QT prolongation may be increased if you have||
1915|156|P|certain medical conditions or are taking other drugs that may||
1915|157|P|cause QT prolongation. Before using||
1915|158|P|efavirenz/lamivudine/tenofovir, tell your doctor or pharmacist of||
1915|159|P|all the drugs you take and if you have any of the following||
1915|160|P|conditions: certain heart problems (heart failure, slow||
1915|161|P|heartbeat, QT prolongation in the EKG), family history of certain||
1915|162|P|heart problems (QT prolongation in the EKG, sudden cardiac||
1915|163|P|death).||
1915|164|P|   Low levels of potassium or magnesium in the blood may also||
1915|165|P|increase your risk of QT prolongation. This risk may increase if||
1915|166|P|you use certain drugs (such as diuretics "water pills") or if you||
1915|167|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1915|168|P|Talk to your doctor about using efavirenz/lamivudine/tenofovir||
1915|169|P|safely.||
1915|170|P|   This drug may make you dizzy or drowsy or cause trouble||
1915|171|P|concentrating. Alcohol or marijuana (cannabis) can worsen these||
1915|172|P|effects. Do not drive, use machinery, or do anything that needs||
1915|173|P|alertness until you can do it safely. Avoid alcoholic beverages||
1915|174|P|because they may also worsen the side effects of this medication||
1915|175|P|(such as liver problems, pancreatitis, mental/mood symptoms).||
1915|176|P|Talk to your doctor if you are using marijuana (cannabis).||
1915|177|P|   Before having surgery, tell your doctor or dentist about all||
1915|178|P|the products you use (including prescription drugs,||
1915|179|P|nonprescription drugs, and herbal products).||
1915|180|P|   Older adults may be more sensitive to the side effects of this||
1915|181|P|drug, especially QT prolongation (see above).||
1915|182|P|   During pregnancy, this medication should be used only when||
1915|183|P|clearly needed. Treatment can lower the risk of passing HIV||
1915|184|P|infection to your baby, and efavirenz/lamivudine/tenofovir may be||
1915|185|P|part of that treatment. Discuss the risks and benefits with your||
1915|186|P|doctor.||
1915|187|P|   This medication passes into breast milk. Because breast milk||
1915|188|P|may transmit HIV, consult your doctor before breastfeeding.||
1915|189|B|||
1915|190|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1915|191|I|medications work or increase your risk for serious side effects.||
1915|192|I|This document does not contain all possible drug interactions.||
1915|193|I|Keep a list of all the products you use (including||
1915|194|I|prescription/nonprescription drugs and herbal products) and share||
1915|195|I|it with your doctor and pharmacist. Do not start, stop, or change||
1915|196|I|the dosage of any medicines without your doctor's approval.||
1915|197|I|   Some products that may interact with this drug are: orlistat,||
1915|198|I|sorbitol, other drugs that may affect the kidneys (including||
1915|199|I|adefovir, cidofovir, aminoglycosides such as||
1915|200|I|amikacin/gentamicin).||
1915|201|I|   Do not take this medication with other products that treat HIV||
1915|202|I|infection. Do not take this medication with other products that||
1915|203|I|contain efavirenz, lamivudine, or tenofovir.||
1915|204|I|   Other medications can affect the removal of||
1915|205|I|efavirenz/lamivudine/tenofovir from your body, which may affect||
1915|206|I|how this product works. Examples include St. John's wort, some||
1915|207|I|drugs used to treat seizures (such as carbamazepine), among||
1915|208|I|others.||
1915|209|I|   Efavirenz/lamivudine/tenofovir can speed up the removal of||
1915|210|I|other medications from your body, which may affect how they work.||
1915|211|I|Examples of affected drugs include atazanavir,||
1915|212|I|atovaquone/proguanil, azole antifungals (such as voriconazole),||
1915|213|I|bedaquiline, cabotegravir, cobicistat, elbasvir/grazoprevir,||
1915|214|I|elvitegravir, macrolide antibiotics (such as clarithromycin),||
1915|215|I|rilpivirine, sofosbuvir/velpatasvir, among others.||
1915|216|I|   This medication may decrease the effectiveness of hormonal||
1915|217|I|birth control such as pills, patch, or ring. This could cause||
1915|218|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1915|219|I|use reliable backup birth control methods while using this||
1915|220|I|medication. Also tell your doctor if you have any new spotting or||
1915|221|I|breakthrough bleeding, because these may be signs that your birth||
1915|222|I|control is not working well.||
1915|223|I|   Tell your doctor or pharmacist if you are taking other||
1915|224|I|products that cause drowsiness including alcohol, marijuana||
1915|225|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
1915|226|I|drugs for sleep or anxiety (such as diazepam, zolpidem), muscle||
1915|227|I|relaxants, and opioid pain relievers (such as codeine).||
1915|228|I|   Check the labels on all your medicines (such as allergy or||
1915|229|I|cough-and-cold products) because they may contain ingredients||
1915|230|I|that cause drowsiness. Ask your pharmacist about using those||
1915|231|I|products safely.||
1915|232|I|   This medication may interfere with certain lab tests||
1915|233|I|(including urine cannabinoid tests), possibly causing false test||
1915|234|I|results. Make sure lab personnel and all your doctors know you||
1915|235|I|use this drug.||
1915|236|B|||
1915|237|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1915|238|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1915|239|O|poison control center right away. US residents can call||
1915|240|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1915|241|B|||
1915|242|N|NOTES:  Do not share this medication with others.||
1915|243|N|   Lab and/or medical tests (such as kidney/liver tests, urine||
1915|244|N|glucose/protein, viral load, T-cell counts, cholesterol and||
1915|245|N|triglyceride levels, blood mineral levels, bone density tests)||
1915|246|N|should be done before you start taking this medication and while||
1915|247|N|you are taking it. Keep all medical and lab appointments.||
1915|248|B|||
1915|249|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1915|250|D|remember. If it is near the time of the next dose, skip the||
1915|251|D|missed dose. Take your next dose at the regular time. Do not||
1915|252|D|double the dose to catch up.||
1915|253|B|||
1915|254|R|STORAGE:  Store in the original container at room temperature||
1915|255|R|away from light and moisture. Do not store in the bathroom. Keep||
1915|256|R|all medications away from children and pets.||
1915|257|R|   Do not flush medications down the toilet or pour them into a||
1915|258|R|drain unless instructed to do so. Properly discard this product||
1915|259|R|when it is expired or no longer needed. Consult your pharmacist||
1915|260|R|or local waste disposal company.||
1915|261|B|||
1915|262|A|Information last revised April 2025.||
1915|263|A|Copyright(c) 2025 First Databank, Inc.||
1915|264|B|||
1916|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1916|002|Z|does NOT have all possible information about this product. This||
1916|003|Z|information does not assure that this product is safe, effective,||
1916|004|Z|or appropriate for you. This information is not individual||
1916|005|Z|medical advice and does not substitute for the advice of your||
1916|006|Z|health care professional. Always ask your health care||
1916|007|Z|professional for complete information about this product and your||
1916|008|Z|specific health needs.||
1916|009|B|||
1916|010|T|SAPROPTERIN - ORAL||
1916|011|F|(SAP-roe-TER-in)||
1916|012|B|||
1916|013|C|COMMON BRAND NAME(S): Kuvan||
1916|014|B|||
1916|015|U|USES:  This medication is used along with diet changes for||
1916|016|U|long-term treatment of a certain inherited disorder||
1916|017|U|(phenylketonuria-PKU). It helps remove a certain chemical||
1916|018|U|(phenylalanine) from the body. Too much phenylalanine in the body||
1916|019|U|can cause brain damage.||
1916|020|B|||
1916|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
1916|022|H|Instructions for Use if available from your pharmacist before you||
1916|023|H|start taking sapropterin and each time you get a refill. If you||
1916|024|H|have any questions, ask your doctor or pharmacist.||
1916|025|H|   Take this medication by mouth with a meal as directed by your||
1916|026|H|doctor, usually once daily. The dosage is based on your medical||
1916|027|H|condition, age, weight, lab tests, and response to treatment.||
1916|028|H|   Swallow the tablets whole or you may dissolve them in 120 to||
1916|029|H|240 milliliters (4 to 8 ounces) of water or apple juice. To help||
1916|030|H|the tablets dissolve faster, you may stir or crush them. Drink||
1916|031|H|this mixture within 15 minutes of mixing. If you see small pieces||
1916|032|H|of the tablet remaining in the cup, add some more water or apple||
1916|033|H|juice to the cup and drink it so you get all of the dose.||
1916|034|H|   You may also crush the tablets and mix them in a small amount||
1916|035|H|of soft food (such as apple sauce or pudding). Eat all of the||
1916|036|H|mixture right away. Do not prepare a supply in advance.||
1916|037|H|   Use this medication regularly to get the most benefit from it.||
1916|038|H|To help you remember, take it at the same time each day.||
1916|039|H|   Tell your doctor if you do not get better or if you get worse.||
1916|040|B|||
1916|041|S|SIDE EFFECTS:  Runny/stuffy nose or sore throat may occur. If any||
1916|042|S|of these effects last or get worse, tell your doctor or||
1916|043|S|pharmacist promptly.||
1916|044|S|   Remember that this medication has been prescribed because your||
1916|045|S|doctor has judged that the benefit to you is greater than the||
1916|046|S|risk of side effects. Many people using this medication do not||
1916|047|S|have serious side effects.||
1916|048|S|   Tell your doctor right away if you have any serious side||
1916|049|S|effects, including: trouble swallowing, pain in the throat,||
1916|050|S|stomach/abdominal pain that doesn't go away, nausea/vomiting that||
1916|051|S|doesn't stop, black stools, blood in your vomit, signs of||
1916|052|S|hyperactivity (such as not being able to sit still).||
1916|053|S|   A very serious allergic reaction to this drug is rare.||
1916|054|S|However, get medical help right away if you notice any symptoms||
1916|055|S|of a serious allergic reaction, including: rash, itching/swelling||
1916|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1916|057|S|breathing.||
1916|058|S|   This is not a complete list of possible side effects. If you||
1916|059|S|notice other effects not listed above, contact your doctor or||
1916|060|S|pharmacist.||
1916|061|S|   In the US -||
1916|062|S|   Call your doctor for medical advice about side effects. You||
1916|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1916|064|S|www.fda.gov/medwatch.||
1916|065|S|   In Canada - Call your doctor for medical advice about side||
1916|066|S|effects. You may report side effects to Health Canada at||
1916|067|S|1-866-234-2345.||
1916|068|B|||
1916|069|P|PRECAUTIONS:  Before taking sapropterin, tell your doctor or||
1916|070|P|pharmacist if you are allergic to it; or if you have any other||
1916|071|P|allergies. This product may contain inactive ingredients, which||
1916|072|P|can cause allergic reactions or other problems. Talk to your||
1916|073|P|pharmacist for more details.||
1916|074|P|   Before using this medication, tell your doctor or pharmacist||
1916|075|P|your medical history, especially of: liver disease.||
1916|076|P|   Before having surgery, tell your doctor or dentist about all||
1916|077|P|the products you use (including prescription drugs,||
1916|078|P|nonprescription drugs, and herbal products).||
1916|079|P|   During pregnancy, this medication should be used only when||
1916|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
1916|081|P|   It is unknown if this medication passes into breast milk.||
1916|082|P|Consult your doctor before breastfeeding.||
1916|083|B|||
1916|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1916|085|I|medications work or increase your risk for serious side effects.||
1916|086|I|This document does not contain all possible drug interactions.||
1916|087|I|Keep a list of all the products you use (including||
1916|088|I|prescription/nonprescription drugs and herbal products) and share||
1916|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
1916|090|I|the dosage of any medicines without your doctor's approval.||
1916|091|B|||
1916|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1916|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1916|094|O|poison control center right away. US residents can call||
1916|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1916|096|B|||
1916|097|N|NOTES:  Do not share this medication with others.||
1916|098|N|   Lab and/or medical tests (such as phenylalanine blood levels)||
1916|099|N|should be done while you are taking this medication. Keep all||
1916|100|N|medical and lab appointments. Consult your doctor for more||
1916|101|N|details.||
1916|102|B|||
1916|103|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
1916|104|D|if it is on the same day. If you do not remember until the next||
1916|105|D|day, skip the missed dose. Take your next dose at the regular||
1916|106|D|time. Do not double the dose to catch up.||
1916|107|B|||
1916|108|R|STORAGE:  Store at room temperature away from light and moisture.||
1916|109|R|Do not store in the bathroom. Keep all medications away from||
1916|110|R|children and pets.||
1916|111|R|   Do not flush medications down the toilet or pour them into a||
1916|112|R|drain unless instructed to do so. Properly discard this product||
1916|113|R|when it is expired or no longer needed. Consult your pharmacist||
1916|114|R|or local waste disposal company.||
1916|115|B|||
1916|116|A|Information last revised October 2024.||
1916|117|A|Copyright(c) 2025 First Databank, Inc.||
1916|118|B|||
1917|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1917|002|Z|does NOT have all possible information about this product. This||
1917|003|Z|information does not assure that this product is safe, effective,||
1917|004|Z|or appropriate for you. This information is not individual||
1917|005|Z|medical advice and does not substitute for the advice of your||
1917|006|Z|health care professional. Always ask your health care||
1917|007|Z|professional for complete information about this product and your||
1917|008|Z|specific health needs.||
1917|009|B|||
1917|010|T|IBALIZUMAB - INJECTION||
1917|011|F|(EYE-ba-LIZ-ue-mab)||
1917|012|B|||
1917|013|C|COMMON BRAND NAME(S): Trogarzo||
1917|014|B|||
1917|015|U|USES:  This drug is used with other HIV medications to help||
1917|016|U|control HIV infection. It helps to decrease the amount of HIV in||
1917|017|U|your body so your immune system can work better. This lowers your||
1917|018|U|chance of getting HIV complications (such as new infections,||
1917|019|U|cancer) and improves your quality of life. Ibalizumab belongs to||
1917|020|U|a class of drugs known as monoclonal antibodies.||
1917|021|U|   Ibalizumab is not a cure for HIV infection. To decrease your||
1917|022|U|risk of spreading HIV disease to others, continue to take all HIV||
1917|023|U|medications exactly as prescribed by your doctor. Use an||
1917|024|U|effective barrier method (latex or polyurethane condoms/dental||
1917|025|U|dams) during sexual activity as directed by your doctor. Do not||
1917|026|U|share personal items (such as needles/syringes, toothbrushes, and||
1917|027|U|razors) that may have contacted blood or other body fluids.||
1917|028|U|Consult your doctor or pharmacist for more details.||
1917|029|B|||
1917|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1917|031|H|from your pharmacist before you start using ibalizumab and each||
1917|032|H|time you get a refill. If you have any questions, ask your doctor||
1917|033|H|or pharmacist.||
1917|034|H|   This medication is given by injection into a vein as directed||
1917|035|H|by your doctor, usually every 2 weeks. The injection is given by||
1917|036|H|a health care professional.||
1917|037|H|   Infusion reactions may happen during the infusion of this drug||
1917|038|H|and for a short time afterward. Tell your doctor right away if||
1917|039|H|you have any symptoms of infusion reactions such as shortness of||
1917|040|H|breath, chest pain/tightness, cough, nausea, vomiting, or hot||
1917|041|H|flashes.||
1917|042|H|   It is very important to keep using this medication (and other||
1917|043|H|HIV medications) exactly as prescribed by your doctor. Do not||
1917|044|H|skip any doses.||
1917|045|H|   Use this medication regularly to get the most benefit from it.||
1917|046|H|To help you remember, mark your calendar with a reminder.||
1917|047|H|   Do not stop using this drug (or other HIV medicines) even for||
1917|048|H|a short time unless directed to do so by your doctor. Doing so||
1917|049|H|may cause the amount of virus to increase, make the infection||
1917|050|H|more difficult to treat (resistant), or worsen side effects.||
1917|051|B|||
1917|052|S|SIDE EFFECTS:  See also How to Uses section.||
1917|053|S|   Nausea, diarrhea, or dizziness may occur. If any of these||
1917|054|S|effects last or get worse, tell your doctor or pharmacist||
1917|055|S|promptly.||
1917|056|S|   Remember that this medication has been prescribed because your||
1917|057|S|doctor has judged that the benefit to you is greater than the||
1917|058|S|risk of side effects. Many people using this medication do not||
1917|059|S|have serious side effects.||
1917|060|S|   As your immune system gets stronger, it can begin to fight off||
1917|061|S|infections you already had, possibly causing disease symptoms to||
1917|062|S|come back. You could also have symptoms if your immune system||
1917|063|S|becomes overactive. This reaction may happen at any time (soon||
1917|064|S|after starting HIV treatment or many months later). Tell your||
1917|065|S|doctor right away if you have any serious symptoms, including:||
1917|066|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1917|067|S|that doesn't go away, headaches that are severe or don't go away,||
1917|068|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1917|069|S|changes, signs of infection (such as sore throat that doesn't go||
1917|070|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1917|071|S|sores), signs of an overactive thyroid (such as irritability,||
1917|072|S|nervousness, heat intolerance, fast/pounding/irregular||
1917|073|S|heartbeat), signs of liver disease (such as nausea/vomiting that||
1917|074|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
1917|075|S|eyes/skin, dark urine).||
1917|076|S|   This medication can commonly cause a rash that is usually not||
1917|077|S|serious. However, you may not be able to tell it apart from a||
1917|078|S|rare rash that could be a sign of a severe reaction. Get medical||
1917|079|S|help right away if you develop any rash.||
1917|080|S|   A very serious allergic reaction to this drug is rare.||
1917|081|S|However, get medical help right away if you notice any symptoms||
1917|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1917|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1917|084|S|breathing.||
1917|085|S|   This is not a complete list of possible side effects. If you||
1917|086|S|notice other effects not listed above, contact your doctor or||
1917|087|S|pharmacist.||
1917|088|S|   In the US -||
1917|089|S|   Call your doctor for medical advice about side effects. You||
1917|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1917|091|S|www.fda.gov/medwatch.||
1917|092|S|   In Canada - Call your doctor for medical advice about side||
1917|093|S|effects. You may report side effects to Health Canada at||
1917|094|S|1-866-234-2345.||
1917|095|B|||
1917|096|P|PRECAUTIONS:  Before using ibalizumab, tell your doctor or||
1917|097|P|pharmacist if you are allergic to it; or if you have any other||
1917|098|P|allergies. This product may contain inactive ingredients, which||
1917|099|P|can cause allergic reactions or other problems. Talk to your||
1917|100|P|pharmacist for more details.||
1917|101|P|   Before using this medication, tell your doctor or pharmacist||
1917|102|P|your medical history.||
1917|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1917|104|P|can make you more dizzy. Do not drive, use machinery, or do||
1917|105|P|anything that needs alertness until you can do it safely. Limit||
1917|106|P|alcoholic beverages. Talk to your doctor if you are using||
1917|107|P|marijuana (cannabis).||
1917|108|P|   Before having surgery, tell your doctor or dentist about all||
1917|109|P|the products you use (including prescription drugs,||
1917|110|P|nonprescription drugs, and herbal products).||
1917|111|P|   During pregnancy, this medication should be used only when||
1917|112|P|clearly needed. Treatment can lower the risk of passing HIV||
1917|113|P|infection to your baby, and ibalizumab may be part of that||
1917|114|P|treatment. Discuss the risks and benefits with your doctor.||
1917|115|P|   It is unknown if this medication passes into breast milk.||
1917|116|P|Because breast milk may transmit HIV, consult your doctor before||
1917|117|P|breastfeeding.||
1917|118|B|||
1917|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1917|120|I|medications work or increase your risk for serious side effects.||
1917|121|I|This document does not contain all possible drug interactions.||
1917|122|I|Keep a list of all the products you use (including||
1917|123|I|prescription/nonprescription drugs and herbal products) and share||
1917|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
1917|125|I|the dosage of any medicines without your doctor's approval.||
1917|126|B|||
1917|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1917|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1917|129|O|poison control center right away. US residents can call||
1917|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1917|131|B|||
1917|132|N|NOTES:  Do not share this medication with others.||
1917|133|N|   Lab and/or medical tests (such as viral load, T-cell counts)||
1917|134|N|should be done while you are using this medication. Keep all||
1917|135|N|medical and lab appointments.||
1917|136|B|||
1917|137|D|MISSED DOSE:  It is important to get each dose of this medication||
1917|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1917|139|D|right away for a new dosing schedule.||
1917|140|B|||
1917|141|R|STORAGE:  Not applicable. This medication is given in a hospital||
1917|142|R|or clinic or doctor's office and will not be stored at home.||
1917|143|B|||
1917|144|A|Information last revised April 2025.||
1917|145|A|Copyright(c) 2025 First Databank, Inc.||
1917|146|B|||
1918|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1918|002|Z|does NOT have all possible information about this product. This||
1918|003|Z|information does not assure that this product is safe, effective,||
1918|004|Z|or appropriate for you. This information is not individual||
1918|005|Z|medical advice and does not substitute for the advice of your||
1918|006|Z|health care professional. Always ask your health care||
1918|007|Z|professional for complete information about this product and your||
1918|008|Z|specific health needs.||
1918|009|B|||
1918|010|T|MIGALASTAT - ORAL||
1918|011|F|(mi-GAL-a-stat)||
1918|012|B|||
1918|013|C|COMMON BRAND NAME(S): Galafold||
1918|014|B|||
1918|015|U|USES:  This medication is used for long-term treatment in people||
1918|016|U|with a certain inherited disease (Fabry disease). In Fabry||
1918|017|U|disease, a certain enzyme in your body (alpha-galactosidase) does||
1918|018|U|not work the way it should. This leads to a buildup of a certain||
1918|019|U|fatty substance in your kidneys, heart, and other organs.||
1918|020|U|Migalastat works by helping alpha-galactosidase work better so it||
1918|021|U|can remove the fatty substance. Treatment can decrease some||
1918|022|U|symptoms caused by Fabry disease, such as abdominal cramps,||
1918|023|U|diarrhea, burning pain in the hands and feet, heat intolerance,||
1918|024|U|skin rash, kidney/heart disease, or stroke.||
1918|025|B|||
1918|026|H|HOW TO USE:  Read the Patient Information Leaflet and||
1918|027|H|Instructions for Use if available from your pharmacist before you||
1918|028|H|start taking migalastat and each time you get a refill. If you||
1918|029|H|have any questions, ask your doctor or pharmacist.||
1918|030|H|   Take this medication by mouth on an empty stomach as directed||
1918|031|H|by your doctor, usually once every other day. Do not take this||
1918|032|H|medication 2 days in a row. Swallow the capsules whole. Do not||
1918|033|H|cut, crush, or chew the capsules.||
1918|034|H|   Do not eat food or take or drink any product that contains||
1918|035|H|caffeine at least 2 hours before and 2 hours after taking this||
1918|036|H|medication. During this time, you may drink water (plain,||
1918|037|H|flavored, or sweetened), fruit juices without pulp, and||
1918|038|H|caffeine-free carbonated beverages. Taking this medication with||
1918|039|H|food or caffeine will make it work less well. Check the labels on||
1918|040|H|all your medicines (such as allergy or cough-and-cold products,||
1918|041|H|pain relievers) because they may also contain caffeine.||
1918|042|H|   Use this medication regularly to get the most benefit from it.||
1918|043|H|To help you remember, take it at the same time every other day.||
1918|044|H|   Do not increase your dose or use this drug more often or for||
1918|045|H|longer than prescribed. Your condition will not improve any||
1918|046|H|faster, and your risk of serious side effects will increase.||
1918|047|H|   Tell your doctor if your condition does not get better or if||
1918|048|H|it gets worse.||
1918|049|B|||
1918|050|S|SIDE EFFECTS:  Headache, nausea, abdominal pain, dry mouth,||
1918|051|S|diarrhea, runny/stuffy nose, nosebleed, numbness/tingling, or||
1918|052|S|dizziness may occur. If any of these effects last or get worse,||
1918|053|S|tell your doctor or pharmacist promptly.||
1918|054|S|   Remember that this medication has been prescribed because your||
1918|055|S|doctor has judged that the benefit to you is greater than the||
1918|056|S|risk of side effects. Many people using this medication do not||
1918|057|S|have serious side effects.||
1918|058|S|   Tell your doctor right away if you have any serious side||
1918|059|S|effects, including: signs of bladder infection (such as||
1918|060|S|burning/pain when you urinate, urgent or frequent urination,||
1918|061|S|fever).||
1918|062|S|   A very serious allergic reaction to this drug is rare.||
1918|063|S|However, get medical help right away if you notice any symptoms||
1918|064|S|of a serious allergic reaction, including: rash, itching/swelling||
1918|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1918|066|S|breathing.||
1918|067|S|   This is not a complete list of possible side effects. If you||
1918|068|S|notice other effects not listed above, contact your doctor or||
1918|069|S|pharmacist.||
1918|070|S|   In the US -||
1918|071|S|   Call your doctor for medical advice about side effects. You||
1918|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1918|073|S|www.fda.gov/medwatch.||
1918|074|S|   In Canada - Call your doctor for medical advice about side||
1918|075|S|effects. You may report side effects to Health Canada at||
1918|076|S|1-866-234-2345.||
1918|077|B|||
1918|078|P|PRECAUTIONS:  Before taking migalastat, tell your doctor or||
1918|079|P|pharmacist if you are allergic to it; or if you have any other||
1918|080|P|allergies. This product may contain inactive ingredients, which||
1918|081|P|can cause allergic reactions or other problems. Talk to your||
1918|082|P|pharmacist for more details.||
1918|083|P|   Before using this medication, tell your doctor or pharmacist||
1918|084|P|your medical history, especially of: kidney disease.||
1918|085|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1918|086|P|can make you more dizzy. Do not drive, use machinery, or do||
1918|087|P|anything that needs alertness until you can do it safely. Limit||
1918|088|P|alcoholic beverages. Talk to your doctor if you are using||
1918|089|P|marijuana (cannabis).||
1918|090|P|   Before having surgery, tell your doctor or dentist about all||
1918|091|P|the products you use (including prescription drugs,||
1918|092|P|nonprescription drugs, and herbal products).||
1918|093|P|   During pregnancy, this medication should be used only when||
1918|094|P|clearly needed. Ask about reliable forms of birth control while||
1918|095|P|using this medication. If you become pregnant, talk to your||
1918|096|P|doctor right away about the risks and benefits of this||
1918|097|P|medication.||
1918|098|P|   It is unknown if this medication passes into breast milk.||
1918|099|P|Consult your doctor before breastfeeding.||
1918|100|B|||
1918|101|I|DRUG INTERACTIONS:  See also How to Use section.||
1918|102|I|   Drug interactions may change how your medications work or||
1918|103|I|increase your risk for serious side effects. This document does||
1918|104|I|not contain all possible drug interactions. Keep a list of all||
1918|105|I|the products you use (including prescription/nonprescription||
1918|106|I|drugs and herbal products) and share it with your doctor and||
1918|107|I|pharmacist. Do not start, stop, or change the dosage of any||
1918|108|I|medicines without your doctor's approval.||
1918|109|I|   A product that may interact with this drug is: agalsidase.||
1918|110|B|||
1918|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1918|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1918|113|O|poison control center right away. US residents can call||
1918|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1918|115|B|||
1918|116|N|NOTES:  Do not share this medication with others.||
1918|117|N|   Lab and/or medical tests (such as kidney function, heart||
1918|118|N|function, specific markers for Fabry disease) should be done||
1918|119|N|while you are taking this medication. Keep all medical and lab||
1918|120|N|appointments.||
1918|121|B|||
1918|122|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1918|123|D|remember. If it is more than 12 hours after the missed dose, skip||
1918|124|D|the missed dose. Take your next dose at the regular time. Do not||
1918|125|D|double the dose to catch up.||
1918|126|B|||
1918|127|R|STORAGE:  Store at room temperature away from light and moisture.||
1918|128|R|Do not store in the bathroom. Keep the medication in the blister||
1918|129|R|pack until ready to use. Keep all medications away from children||
1918|130|R|and pets.||
1918|131|R|   Do not flush medications down the toilet or pour them into a||
1918|132|R|drain unless instructed to do so. Properly discard this product||
1918|133|R|when it is expired or no longer needed. Consult your pharmacist||
1918|134|R|or local waste disposal company.||
1918|135|B|||
1918|136|A|Information last revised May 2024.||
1918|137|A|Copyright(c) 2025 First Databank, Inc.||
1918|138|B|||
1919|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1919|002|Z|does NOT have all possible information about this product. This||
1919|003|Z|information does not assure that this product is safe, effective,||
1919|004|Z|or appropriate for you. This information is not individual||
1919|005|Z|medical advice and does not substitute for the advice of your||
1919|006|Z|health care professional. Always ask your health care||
1919|007|Z|professional for complete information about this product and your||
1919|008|Z|specific health needs.||
1919|009|B|||
1919|010|T|NETARSUDIL SOLUTION - OPHTHALMIC||
1919|011|F|(ne-TAR-soo-dil)||
1919|012|B|||
1919|013|C|COMMON BRAND NAME(S): Rhopressa||
1919|014|B|||
1919|015|U|USES:  Netarsudil is used to treat high pressure inside the eye||
1919|016|U|due to certain eye conditions (such as open-angle glaucoma,||
1919|017|U|ocular hypertension). This medication is thought to work by||
1919|018|U|increasing the flow of fluid out of the eye. This helps lower||
1919|019|U|pressure inside the eye. Lowering high pressure inside the eye||
1919|020|U|can help prevent loss of vision or blindness.||
1919|021|B|||
1919|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
1919|023|H|directed by your doctor, usually once a day in the evening. Do||
1919|024|H|not use netarsudil more often because it may increase your risk||
1919|025|H|for side effects.||
1919|026|H|   To apply eye drops, wash hands first. To avoid contamination,||
1919|027|H|do not touch the dropper tip or let it touch your eye or any||
1919|028|H|other surface.||
1919|029|H|   If you are wearing contact lenses, remove them before using||
1919|030|H|eye drops. Wait at least 15 minutes before replacing your contact||
1919|031|H|lenses. Tilt your head back, look upward, and pull down the lower||
1919|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1919|033|H|and place one drop into the pouch. Look downward, gently close||
1919|034|H|your eyes, and place one finger at the corner of your eye (near||
1919|035|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
1919|036|H|opening your eyes. This will prevent the medication from draining||
1919|037|H|out. Try not to blink or rub your eye. If directed to use this||
1919|038|H|medication in both eyes, repeat these steps for your other eye.||
1919|039|H|Do not rinse the dropper. Replace the dropper cap after each use.||
1919|040|H|   If you are using another kind of eye medication (such as drops||
1919|041|H|or ointments), wait at least 5 minutes before applying other||
1919|042|H|medications. Use eye drops before eye ointments to allow the||
1919|043|H|drops to enter the eye.||
1919|044|H|   Wait several minutes for your vision to clear before driving||
1919|045|H|or operating machinery.||
1919|046|H|   Use this medication regularly to get the most benefit from it.||
1919|047|H|To help you remember, use it at the same time each day. Keep||
1919|048|H|using netarsudil even if you feel well. Most people with glaucoma||
1919|049|H|or high pressure in the eye do not have symptoms.||
1919|050|B|||
1919|051|S|SIDE EFFECTS:  Eye discomfort, redness, tearing, temporary||
1919|052|S|blurred vision, eyelid redness, or corneal staining may occur. If||
1919|053|S|any of these effects last or get worse, tell your doctor or||
1919|054|S|pharmacist promptly.||
1919|055|S|   Remember that this medication has been prescribed because your||
1919|056|S|doctor has judged that the benefit to you is greater than the||
1919|057|S|risk of side effects. Many people using this medication do not||
1919|058|S|have serious side effects.||
1919|059|S|   Tell your doctor right away if you have any serious side||
1919|060|S|effects, including: vision changes, eye pain.||
1919|061|S|   A very serious allergic reaction to this drug is rare.||
1919|062|S|However, get medical help right away if you notice any symptoms||
1919|063|S|of a serious allergic reaction, including: rash, itching/swelling||
1919|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1919|065|S|breathing.||
1919|066|S|   This is not a complete list of possible side effects. If you||
1919|067|S|notice other effects not listed above, contact your doctor or||
1919|068|S|pharmacist.||
1919|069|S|   In the US -||
1919|070|S|   Call your doctor for medical advice about side effects. You||
1919|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1919|072|S|www.fda.gov/medwatch.||
1919|073|S|   In Canada - Call your doctor for medical advice about side||
1919|074|S|effects. You may report side effects to Health Canada at||
1919|075|S|1-866-234-2345.||
1919|076|B|||
1919|077|P|PRECAUTIONS:  Before using netarsudil, tell your doctor or||
1919|078|P|pharmacist if you are allergic to it; or if you have any other||
1919|079|P|allergies. This product may contain inactive ingredients, which||
1919|080|P|can cause allergic reactions or other problems. Talk to your||
1919|081|P|pharmacist for more details.||
1919|082|P|   Before using this medication, tell your doctor or pharmacist||
1919|083|P|your medical history, especially of: eye problems (such as||
1919|084|P|macular edema, iritis, uveitis, lens extraction/aphakia).||
1919|085|P|   After you apply this drug, your vision may become temporarily||
1919|086|P|blurred. Do not drive, use machinery, or do anything that needs||
1919|087|P|clear vision until you can do it safely.||
1919|088|P|   If you develop an eye infection or injury, or have eye||
1919|089|P|surgery, ask your doctor if you should continue to use this||
1919|090|P|medication.||
1919|091|P|   Before having surgery, tell your doctor or dentist about all||
1919|092|P|the products you use (including prescription drugs,||
1919|093|P|nonprescription drugs, and herbal products).||
1919|094|P|   During pregnancy, this medication should be used only when||
1919|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1919|096|P|   It is unknown if this medication passes into breast milk.||
1919|097|P|Consult your doctor before breastfeeding.||
1919|098|B|||
1919|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1919|100|I|medications work or increase your risk for serious side effects.||
1919|101|I|This document does not contain all possible drug interactions.||
1919|102|I|Keep a list of all the products you use (including||
1919|103|I|prescription/nonprescription drugs and herbal products) and share||
1919|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1919|105|I|the dosage of any medicines without your doctor's approval.||
1919|106|B|||
1919|107|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1919|108|O|has overdosed and has serious symptoms such as passing out or||
1919|109|O|trouble breathing, call 911. Otherwise, call a poison control||
1919|110|O|center right away. US residents can call 1-800-222-1222. Canada||
1919|111|O|residents can call 1-844-764-7669.||
1919|112|B|||
1919|113|N|NOTES:  Do not share this medication with others.||
1919|114|N|   Lab and/or medical tests (such as eye exams) should be done||
1919|115|N|while you are using this medication. Keep all medical and lab||
1919|116|N|appointments.||
1919|117|B|||
1919|118|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1919|119|D|next dose at the regular time. Do not double the dose to catch||
1919|120|D|up.||
1919|121|B|||
1919|122|R|STORAGE:  Store the unopened bottle in the refrigerator. Store||
1919|123|R|the opened bottle in the refrigerator or at room temperature. If||
1919|124|R|the opened bottle is stored at room temperature, discard after 6||
1919|125|R|weeks. Keep all medications away from children and pets.||
1919|126|R|   Do not flush medications down the toilet or pour them into a||
1919|127|R|drain unless instructed to do so. Properly discard this product||
1919|128|R|when it is expired or no longer needed. Consult your pharmacist||
1919|129|R|or local waste disposal company.||
1919|130|B|||
1919|131|A|Information last revised September 2024.||
1919|132|A|Copyright(c) 2025 First Databank, Inc.||
1919|133|B|||
1920|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1920|002|Z|does NOT have all possible information about this product. This||
1920|003|Z|information does not assure that this product is safe, effective,||
1920|004|Z|or appropriate for you. This information is not individual||
1920|005|Z|medical advice and does not substitute for the advice of your||
1920|006|Z|health care professional. Always ask your health care||
1920|007|Z|professional for complete information about this product and your||
1920|008|Z|specific health needs.||
1920|009|B|||
1920|010|T|SAPROPTERIN POWDER PACKET - ORAL||
1920|011|F|(SAP-roe-TER-in)||
1920|012|B|||
1920|013|C|COMMON BRAND NAME(S): Kuvan||
1920|014|B|||
1920|015|U|USES:  This medication is used along with diet changes for||
1920|016|U|long-term treatment of a certain inherited disorder||
1920|017|U|(phenylketonuria-PKU). It helps remove a certain chemical||
1920|018|U|(phenylalanine) from the body. Too much phenylalanine in the body||
1920|019|U|can cause brain damage.||
1920|020|B|||
1920|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
1920|022|H|Instructions for Use if available from your pharmacist before you||
1920|023|H|start taking sapropterin and each time you get a refill. If you||
1920|024|H|have any questions, ask your doctor or pharmacist.||
1920|025|H|   Take this medication by mouth with a meal as directed by your||
1920|026|H|doctor, usually once daily. The dosage is based on your medical||
1920|027|H|condition, age, weight, lab tests, and response to treatment.||
1920|028|H|   Open the packet and pour its contents into 120 to 240||
1920|029|H|milliliters (4 to 8 ounces) of water or apple juice. Stir well||
1920|030|H|until the powder dissolves completely (2 to 3 minutes). Drink all||
1920|031|H|of the mixture within 30 minutes of mixing. You may also mix the||
1920|032|H|powder in a small amount of soft food (such as apple sauce or||
1920|033|H|pudding). Eat all of the mixture right away. Do not prepare a||
1920|034|H|supply in advance.||
1920|035|H|   If the dose is less than a full packet, ask your doctor or||
1920|036|H|pharmacist how much water or apple juice you should use to mix||
1920|037|H|with the dose. Mix the entire contents of the packet in water or||
1920|038|H|apple juice as directed by your doctor. Mix well and measure the||
1920|039|H|dose using a special measuring device. Do not use a household||
1920|040|H|spoon because you may not get the correct dose. Take the dose||
1920|041|H|within 30 minutes of mixing. Discard any unused medication.||
1920|042|H|   Use this medication regularly to get the most benefit from it.||
1920|043|H|To help you remember, take it at the same time each day.||
1920|044|H|   Tell your doctor if you do not get better or if you get worse.||
1920|045|B|||
1920|046|S|SIDE EFFECTS:  Runny/stuffy nose or sore throat may occur. If any||
1920|047|S|of these effects last or get worse, tell your doctor or||
1920|048|S|pharmacist promptly.||
1920|049|S|   Remember that this medication has been prescribed because your||
1920|050|S|doctor has judged that the benefit to you is greater than the||
1920|051|S|risk of side effects. Many people using this medication do not||
1920|052|S|have serious side effects.||
1920|053|S|   Tell your doctor right away if you have any serious side||
1920|054|S|effects, including: trouble swallowing, pain in the throat,||
1920|055|S|stomach/abdominal pain that doesn't go away, nausea/vomiting that||
1920|056|S|doesn't stop, black stools, blood in your vomit, signs of||
1920|057|S|hyperactivity (such as not being able to sit still).||
1920|058|S|   A very serious allergic reaction to this drug is rare.||
1920|059|S|However, get medical help right away if you notice any symptoms||
1920|060|S|of a serious allergic reaction, including: rash, itching/swelling||
1920|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1920|062|S|breathing.||
1920|063|S|   This is not a complete list of possible side effects. If you||
1920|064|S|notice other effects not listed above, contact your doctor or||
1920|065|S|pharmacist.||
1920|066|S|   In the US -||
1920|067|S|   Call your doctor for medical advice about side effects. You||
1920|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1920|069|S|www.fda.gov/medwatch.||
1920|070|S|   In Canada - Call your doctor for medical advice about side||
1920|071|S|effects. You may report side effects to Health Canada at||
1920|072|S|1-866-234-2345.||
1920|073|B|||
1920|074|P|PRECAUTIONS:  Before taking sapropterin, tell your doctor or||
1920|075|P|pharmacist if you are allergic to it; or if you have any other||
1920|076|P|allergies. This product may contain inactive ingredients, which||
1920|077|P|can cause allergic reactions or other problems. Talk to your||
1920|078|P|pharmacist for more details.||
1920|079|P|   Before using this medication, tell your doctor or pharmacist||
1920|080|P|your medical history, especially of: liver disease.||
1920|081|P|   Before having surgery, tell your doctor or dentist about all||
1920|082|P|the products you use (including prescription drugs,||
1920|083|P|nonprescription drugs, and herbal products).||
1920|084|P|   During pregnancy, this medication should be used only when||
1920|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
1920|086|P|   It is unknown if this medication passes into breast milk.||
1920|087|P|Consult your doctor before breastfeeding.||
1920|088|B|||
1920|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1920|090|I|medications work or increase your risk for serious side effects.||
1920|091|I|This document does not contain all possible drug interactions.||
1920|092|I|Keep a list of all the products you use (including||
1920|093|I|prescription/nonprescription drugs and herbal products) and share||
1920|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
1920|095|I|the dosage of any medicines without your doctor's approval.||
1920|096|B|||
1920|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1920|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1920|099|O|poison control center right away. US residents can call||
1920|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1920|101|B|||
1920|102|N|NOTES:  Do not share this medication with others.||
1920|103|N|   Lab and/or medical tests (such as phenylalanine blood levels)||
1920|104|N|should be done while you are taking this medication. Keep all||
1920|105|N|medical and lab appointments. Consult your doctor for more||
1920|106|N|details.||
1920|107|B|||
1920|108|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
1920|109|D|if it is on the same day. If you do not remember until the next||
1920|110|D|day, skip the missed dose. Take your next dose at the regular||
1920|111|D|time. Do not double the dose to catch up.||
1920|112|B|||
1920|113|R|STORAGE:  Store at room temperature away from light and moisture.||
1920|114|R|Do not store in the bathroom. Keep all medications away from||
1920|115|R|children and pets.||
1920|116|R|   Do not flush medications down the toilet or pour them into a||
1920|117|R|drain unless instructed to do so. Properly discard this product||
1920|118|R|when it is expired or no longer needed. Consult your pharmacist||
1920|119|R|or local waste disposal company.||
1920|120|B|||
1920|121|A|Information last revised October 2024.||
1920|122|A|Copyright(c) 2025 First Databank, Inc.||
1920|123|B|||
1921|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1921|002|Z|does NOT have all possible information about this product. This||
1921|003|Z|information does not assure that this product is safe, effective,||
1921|004|Z|or appropriate for you. This information is not individual||
1921|005|Z|medical advice and does not substitute for the advice of your||
1921|006|Z|health care professional. Always ask your health care||
1921|007|Z|professional for complete information about this product and your||
1921|008|Z|specific health needs.||
1921|009|B|||
1921|010|T|LAMIVUDINE/TENOFOVIR - ORAL||
1921|011|F|(la-MIV-ue-deen/ten-OF-oh-vir)||
1921|012|B|||
1921|013|C|COMMON BRAND NAME(S): Cimduo, Temixys||
1921|014|B|||
1921|015|W|WARNING:  If you have hepatitis B infection as well as HIV, your||
1921|016|W|hepatitis symptoms may get worse or become very serious if you||
1921|017|W|stop taking this medication. Talk with your doctor before||
1921|018|W|stopping this medication. Your doctor will check your liver||
1921|019|W|function tests for several months after you stop. Tell your||
1921|020|W|doctor right away if you develop symptoms of worsening liver||
1921|021|W|problems.||
1921|022|B|||
1921|023|U|USES:  This combination product is used with other HIV||
1921|024|U|medications to help control HIV infection. It helps to decrease||
1921|025|U|the amount of HIV in your body so your immune system can work||
1921|026|U|better. This lowers your chance of getting HIV complications||
1921|027|U|(such as new infections, cancer) and improves your quality of||
1921|028|U|life. This product is a combination of 2 different drugs:||
1921|029|U|lamivudine and tenofovir. Lamivudine is called a nucleoside||
1921|030|U|reverse transcriptase inhibitor and tenofovir is called a||
1921|031|U|nucleotide reverse transcriptase inhibitor. Lamivudine and||
1921|032|U|tenofovir are often called NRTIs.||
1921|033|U|   Lamivudine/tenofovir is not a cure for HIV infection. To||
1921|034|U|decrease your risk of spreading HIV disease to others, continue||
1921|035|U|to take all HIV medications exactly as prescribed by your doctor.||
1921|036|U|Use an effective barrier method (latex or polyurethane||
1921|037|U|condoms/dental dams) during sexual activity as directed by your||
1921|038|U|doctor. Do not share personal items (such as needles/syringes,||
1921|039|U|toothbrushes, and razors) that may have contacted blood or other||
1921|040|U|body fluids. Consult your doctor or pharmacist for more details.||
1921|041|B|||
1921|042|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1921|043|H|from your pharmacist before you start taking lamivudine/tenofovir||
1921|044|H|and each time you get a refill. If you have any questions, ask||
1921|045|H|your doctor or pharmacist.||
1921|046|H|   Take this medication by mouth as directed by your doctor,||
1921|047|H|usually once daily with or without food.||
1921|048|H|   It is very important to keep taking this medication (and other||
1921|049|H|HIV medications) exactly as prescribed by your doctor. Do not||
1921|050|H|skip any doses.||
1921|051|H|   For the best effect, take this medication at evenly spaced||
1921|052|H|times. To help you remember, take this medication at the same||
1921|053|H|time every day.||
1921|054|H|   Do not take more or less of this drug than prescribed or stop||
1921|055|H|taking it even for a short time unless directed to do so by your||
1921|056|H|doctor. Doing so may cause the amount of virus to increase, make||
1921|057|H|the infection more difficult to treat (resistant), or worsen side||
1921|058|H|effects.||
1921|059|B|||
1921|060|S|SIDE EFFECTS:  Dizziness, headache, diarrhea, nausea, or trouble||
1921|061|S|sleeping may occur. If any of these effects last or get worse,||
1921|062|S|tell your doctor or pharmacist promptly.||
1921|063|S|   Remember that this medication has been prescribed because your||
1921|064|S|doctor has judged that the benefit to you is greater than the||
1921|065|S|risk of side effects. Many people using this medication do not||
1921|066|S|have serious side effects.||
1921|067|S|   As your immune system gets stronger, it can begin to fight off||
1921|068|S|infections you already had, possibly causing disease symptoms to||
1921|069|S|come back. You could also have symptoms if your immune system||
1921|070|S|becomes overactive. This reaction may happen at any time (soon||
1921|071|S|after starting HIV treatment or many months later). Tell your||
1921|072|S|doctor right away if you have any serious symptoms, including:||
1921|073|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1921|074|S|that doesn't go away, headaches that are severe or don't go away,||
1921|075|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1921|076|S|changes, signs of infection (such as sore throat that doesn't go||
1921|077|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1921|078|S|sores), signs of an overactive thyroid (such as irritability,||
1921|079|S|nervousness, heat intolerance, fast/pounding/irregular||
1921|080|S|heartbeat).||
1921|081|S|   Tell your doctor right away if you have any serious side||
1921|082|S|effects, including: signs of kidney problems (such as a change in||
1921|083|S|the amount of urine), signs of a buildup of lactic acid in the||
1921|084|S|blood (such as unusual tiredness, dizziness, severe drowsiness,||
1921|085|S|chills, blue/cold skin, muscle pain, fast/difficult breathing,||
1921|086|S|slow/irregular heartbeat, or stomach pain with||
1921|087|S|nausea/vomiting/diarrhea), signs of liver problems (such as||
1921|088|S|nausea/vomiting that doesn't stop, loss of appetite,||
1921|089|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1921|090|S|mental/mood changes (such as depression, anxiety, confusion),||
1921|091|S|signs of pancreatitis (such as stomach/abdominal/back pain,||
1921|092|S|nausea, fever).||
1921|093|S|   Changes in body fat may occur while you are taking this||
1921|094|S|medication (such as increased fat in the upper back and stomach||
1921|095|S|areas, decreased fat in the arms and legs). The cause and||
1921|096|S|long-term effects of these changes are unknown. Discuss the risks||
1921|097|S|and benefits of treatment with your doctor, as well as the||
1921|098|S|possible use of exercise to reduce this side effect.||
1921|099|S|   Tenofovir may increase the risk of bone loss. Discuss the||
1921|100|S|risks and benefits of treatment with your doctor, as well as the||
1921|101|S|possible use of calcium and vitamin D to reduce this side effect.||
1921|102|S|If you are at risk for bone loss, your doctor may monitor your||
1921|103|S|bone mineral density. Tell your doctor right away if any of the||
1921|104|S|following serious side effects occur: bone pain, easily broken||
1921|105|S|bones.||
1921|106|S|   Lamivudine/tenofovir can commonly cause a rash that is usually||
1921|107|S|not serious. However, you may not be able to tell it apart from a||
1921|108|S|rare rash that could be a sign of a severe reaction. Get medical||
1921|109|S|help right away if you develop any rash.||
1921|110|S|   A very serious allergic reaction to this drug is rare.||
1921|111|S|However, get medical help right away if you notice any symptoms||
1921|112|S|of a serious allergic reaction, including: rash, itching/swelling||
1921|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1921|114|S|breathing.||
1921|115|S|   This is not a complete list of possible side effects. If you||
1921|116|S|notice other effects not listed above, contact your doctor or||
1921|117|S|pharmacist.||
1921|118|S|   In the US -||
1921|119|S|   Call your doctor for medical advice about side effects. You||
1921|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1921|121|S|www.fda.gov/medwatch.||
1921|122|S|   In Canada - Call your doctor for medical advice about side||
1921|123|S|effects. You may report side effects to Health Canada at||
1921|124|S|1-866-234-2345.||
1921|125|B|||
1921|126|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1921|127|P|pharmacist if you are allergic to lamivudine or tenofovir; or if||
1921|128|P|you have any other allergies. This product may contain inactive||
1921|129|P|ingredients, which can cause allergic reactions or other||
1921|130|P|problems. Talk to your pharmacist for more details.||
1921|131|P|   Before using this medication, tell your doctor or pharmacist||
1921|132|P|your medical history, especially of: kidney problems, liver||
1921|133|P|problems (such as hepatitis B or C, cirrhosis), bone problems||
1921|134|P|(such as bone disease, bone loss/osteoporosis, weak/broken||
1921|135|P|bones), disease of the pancreas (pancreatitis).||
1921|136|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1921|137|P|can make you more dizzy. Do not drive, use machinery, or do||
1921|138|P|anything that needs alertness until you can do it safely. Avoid||
1921|139|P|alcoholic beverages because they may also worsen the side effects||
1921|140|P|of this medication (such as liver problems, pancreatitis,||
1921|141|P|mental/mood symptoms). Talk to your doctor if you are using||
1921|142|P|marijuana (cannabis).||
1921|143|P|   Before having surgery, tell your doctor or dentist about all||
1921|144|P|the products you use (including prescription drugs,||
1921|145|P|nonprescription drugs, and herbal products).||
1921|146|P|   During pregnancy, this medication should be used only when||
1921|147|P|clearly needed. Treatment can lower the risk of passing HIV||
1921|148|P|infection to your baby, and lamivudine/tenofovir may be part of||
1921|149|P|that treatment. Discuss the risks and benefits with your doctor.||
1921|150|P|   This medication passes into breast milk. Because breast milk||
1921|151|P|may transmit HIV, consult your doctor before breastfeeding.||
1921|152|B|||
1921|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1921|154|I|medications work or increase your risk for serious side effects.||
1921|155|I|This document does not contain all possible drug interactions.||
1921|156|I|Keep a list of all the products you use (including||
1921|157|I|prescription/nonprescription drugs and herbal products) and share||
1921|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
1921|159|I|the dosage of any medicines without your doctor's approval.||
1921|160|I|   Some products that may interact with this drug are: orlistat,||
1921|161|I|sorbitol, other drugs that may affect the kidneys (including||
1921|162|I|adefovir, cidofovir, aminoglycosides such as||
1921|163|I|amikacin/gentamicin).||
1921|164|I|   Do not take this medication with other products that contain||
1921|165|I|lamivudine or tenofovir.||
1921|166|I|   This medication may interfere with certain lab tests||
1921|167|I|(including urine cannabinoid tests), possibly causing false test||
1921|168|I|results. Make sure lab personnel and all your doctors know you||
1921|169|I|use this drug.||
1921|170|B|||
1921|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1921|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1921|173|O|poison control center right away. US residents can call||
1921|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1921|175|B|||
1921|176|N|NOTES:  Do not share this medication with others.||
1921|177|N|   Lab and/or medical tests (such as kidney/liver tests, urine||
1921|178|N|glucose/protein, viral load, T-cell counts, bone density) should||
1921|179|N|be done before you start taking this medication and while you are||
1921|180|N|taking it. Keep all medical and lab appointments.||
1921|181|B|||
1921|182|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1921|183|D|remember. If it is near the time of the next dose, skip the||
1921|184|D|missed dose. Take your next dose at the regular time. Do not||
1921|185|D|double the dose to catch up.||
1921|186|B|||
1921|187|R|STORAGE:  Store in the original container at room temperature||
1921|188|R|away from light and moisture. Do not store in the bathroom. Keep||
1921|189|R|all medications away from children and pets.||
1921|190|R|   Do not flush medications down the toilet or pour them into a||
1921|191|R|drain unless instructed to do so. Properly discard this product||
1921|192|R|when it is expired or no longer needed. Consult your pharmacist||
1921|193|R|or local waste disposal company.||
1921|194|B|||
1921|195|A|Information last revised April 2025.||
1921|196|A|Copyright(c) 2025 First Databank, Inc.||
1921|197|B|||
1922|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1922|002|Z|does NOT have all possible information about this product. This||
1922|003|Z|information does not assure that this product is safe, effective,||
1922|004|Z|or appropriate for you. This information is not individual||
1922|005|Z|medical advice and does not substitute for the advice of your||
1922|006|Z|health care professional. Always ask your health care||
1922|007|Z|professional for complete information about this product and your||
1922|008|Z|specific health needs.||
1922|009|B|||
1922|010|T|TOLVAPTAN (INHERITED KIDNEY DISEASE) - ORAL||
1922|011|F|(tol-VAP-tan)||
1922|012|B|||
1922|013|C|COMMON BRAND NAME(S): Jynarque||
1922|014|B|||
1922|015|W|WARNING:  Tolvaptan may rarely cause serious (possibly fatal)||
1922|016|W|liver disease. Careful monitoring by your doctor may decrease||
1922|017|W|your risk. Lab/medical tests (such as liver function, kidney||
1922|018|W|function, uric acid/sodium/potassium blood levels) must be done||
1922|019|W|before you start taking this medication and while you are taking||
1922|020|W|it. Keep all medical and lab appointments. Get medical help right||
1922|021|W|away if you have any symptoms of liver damage, such as:||
1922|022|W|nausea/vomiting that doesn't stop, loss of appetite,||
1922|023|W|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
1922|024|W|   To receive tolvaptan in the United States, you must||
1922|025|W|understand, agree to, and carefully follow the requirements of||
1922|026|W|the REMS Program for this medication. If you live in Canada or||
1922|027|W|any other country, consult your doctor and pharmacist for your||
1922|028|W|country's regulations.||
1922|029|B|||
1922|030|U|USES:  This medication is used by people who have a certain||
1922|031|U|inherited kidney problem (autosomal dominant polycystic kidney||
1922|032|U|disease-ADPKD). This inherited kidney problem leads to the growth||
1922|033|U|of fluid-filled sacs (cysts) in your kidneys. Over time, the||
1922|034|U|cysts grow in size, which can damage the way your kidneys work||
1922|035|U|and lead to kidney failure. Tolvaptan belongs to a class of drugs||
1922|036|U|known as vasopressin receptor antagonists. It works by slowing||
1922|037|U|the growth of kidney cysts caused by ADPKD. This effect helps||
1922|038|U|protect your kidneys from damage and failure.||
1922|039|U|   Different brands of this medication have different uses. Do||
1922|040|U|not change brands of this medication unless directed by your||
1922|041|U|doctor.||
1922|042|B|||
1922|043|H|HOW TO USE:  Read the Medication Guide provided by your||
1922|044|H|pharmacist before you start using tolvaptan and each time you get||
1922|045|H|a refill. If you have any questions, ask your doctor or||
1922|046|H|pharmacist.||
1922|047|H|   Take this medication by mouth with or without food as directed||
1922|048|H|by your doctor, usually 2 times a day (once when you wake up and||
1922|049|H|once 8 hours later). To prevent dehydration, always have water||
1922|050|H|ready to drink while taking tolvaptan. Drink water when you are||
1922|051|H|thirsty and throughout the day and night if awake. Stop taking||
1922|052|H|this medication and tell your doctor right away if you have||
1922|053|H|vomiting or diarrhea, or if you cannot drink enough water for any||
1922|054|H|reason.||
1922|055|H|   The dosage is based on your medical condition and response to||
1922|056|H|treatment. To reduce your risk of side effects, your doctor may||
1922|057|H|direct you to start this medication at a low dose and gradually||
1922|058|H|increase your dose. Follow your doctor's instructions carefully.||
1922|059|H|   Use this medication regularly to get the most benefit from it.||
1922|060|H|To help you remember, take it at the same times each day.||
1922|061|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1922|062|H|using this medication unless your doctor or pharmacist says you||
1922|063|H|may do so safely. Grapefruit can increase the chance of side||
1922|064|H|effects with this medicine. Ask your doctor or pharmacist for||
1922|065|H|more details.||
1922|066|B|||
1922|067|S|SIDE EFFECTS:  See also Warning section.||
1922|068|S|   Increased urination and thirst are common side effects. Dry||
1922|069|S|mouth, loss of appetite, or upset stomach may also occur. If any||
1922|070|S|of these effects bother you or get worse, tell your doctor or||
1922|071|S|pharmacist promptly.||
1922|072|S|   Remember that this medication has been prescribed because your||
1922|073|S|doctor has judged that the benefit to you is greater than the||
1922|074|S|risk of side effects. Many people using this medication do not||
1922|075|S|have serious side effects.||
1922|076|S|   Dehydration can occur. The risk is increased if you have||
1922|077|S|vomiting or diarrhea that doesn't stop, and you cannot drink||
1922|078|S|normally. Tell your doctor right away if you notice any symptoms||
1922|079|S|of dehydration, such as fast heartbeat or||
1922|080|S|dizziness/lightheadedness.||
1922|081|S|   A very serious allergic reaction to this drug is rare.||
1922|082|S|However, get medical help right away if you notice any symptoms||
1922|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1922|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1922|085|S|breathing.||
1922|086|S|   This is not a complete list of possible side effects. If you||
1922|087|S|notice other effects not listed above, contact your doctor or||
1922|088|S|pharmacist.||
1922|089|S|   In the US -||
1922|090|S|   Call your doctor for medical advice about side effects. You||
1922|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1922|092|S|www.fda.gov/medwatch.||
1922|093|S|   In Canada - Call your doctor for medical advice about side||
1922|094|S|effects. You may report side effects to Health Canada at||
1922|095|S|1-866-234-2345.||
1922|096|B|||
1922|097|P|PRECAUTIONS:  Before taking tolvaptan, tell your doctor or||
1922|098|P|pharmacist if you are allergic to it; or if you have any other||
1922|099|P|allergies. This product may contain inactive ingredients, which||
1922|100|P|can cause allergic reactions or other problems. Talk to your||
1922|101|P|pharmacist for more details.||
1922|102|P|   Before using this medication, tell your doctor or pharmacist||
1922|103|P|your medical history, especially of: liver disease, gout, trouble||
1922|104|P|urinating (such as due to enlarged prostate, blockage, inability||
1922|105|P|to make urine), abnormal sodium (salt) levels in the blood.||
1922|106|P|   To prevent dehydration while taking this medication, you must||
1922|107|P|be able to replace fluids by drinking. Before taking this||
1922|108|P|medication, tell your doctor if you are not able to drink||
1922|109|P|normally or if you cannot feel if you are thirsty. (See also How||
1922|110|P|to Use section.)||
1922|111|P|   This drug may make you dizzy, especially if you are also||
1922|112|P|taking medication(s) for high blood pressure. Alcohol or||
1922|113|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
1922|114|P|machinery, or do anything that needs alertness until you can do||
1922|115|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1922|116|P|are using marijuana (cannabis).||
1922|117|P|   This medication may rarely make your blood sugar rise, which||
1922|118|P|can cause or worsen diabetes. If you have diabetes, check your||
1922|119|P|blood sugar regularly as directed and share the results with your||
1922|120|P|doctor. Your doctor may need to adjust your diabetes medication,||
1922|121|P|exercise program, or diet.||
1922|122|P|   Before having surgery, tell your doctor or dentist about all||
1922|123|P|the products you use (including prescription drugs,||
1922|124|P|nonprescription drugs, and herbal products).||
1922|125|P|   During pregnancy, this medication should be used only when||
1922|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
1922|127|P|   It is unknown if this medication passes into breast milk.||
1922|128|P|Consult your doctor before breastfeeding.||
1922|129|B|||
1922|130|I|DRUG INTERACTIONS:  See also How to Use section.||
1922|131|I|   Drug interactions may change how your medications work or||
1922|132|I|increase your risk for serious side effects. This document does||
1922|133|I|not contain all possible drug interactions. Keep a list of all||
1922|134|I|the products you use (including prescription/nonprescription||
1922|135|I|drugs and herbal products) and share it with your doctor and||
1922|136|I|pharmacist. Do not start, stop, or change the dosage of any||
1922|137|I|medicines without your doctor's approval.||
1922|138|I|   A product that may interact with this drug is: desmopressin.||
1922|139|I|   Other medications can affect the removal of tolvaptan from||
1922|140|I|your body, which may affect how tolvaptan works. Examples include||
1922|141|I|azole antifungals (such as ketoconazole, itraconazole),||
1922|142|I|cobicistat, HIV protease inhibitors (such as lopinavir),||
1922|143|I|macrolide antibiotics (such as clarithromycin, erythromycin),||
1922|144|I|ribociclib, rifamycins (such as rifabutin, rifampin), ritonavir,||
1922|145|I|St. John's wort, drugs used to treat seizures (such as||
1922|146|I|carbamazepine, phenytoin), among others.||
1922|147|B|||
1922|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1922|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1922|150|O|poison control center right away. US residents can call||
1922|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1922|152|B|||
1922|153|N|NOTES:  Do not share this medication with others.||
1922|154|B|||
1922|155|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1922|156|D|next dose at the regular scheduled time and at the dose||
1922|157|D|prescribed for that time. Do not double the dose to catch up.||
1922|158|B|||
1922|159|R|STORAGE:  Store at room temperature away from light and moisture.||
1922|160|R|Do not store in the bathroom. Keep all medications away from||
1922|161|R|children and pets.||
1922|162|R|   Do not flush medications down the toilet or pour them into a||
1922|163|R|drain unless instructed to do so. Properly discard this product||
1922|164|R|when it is expired or no longer needed. Consult your pharmacist||
1922|165|R|or local waste disposal company.||
1922|166|B|||
1922|167|A|Information last revised May 2024.||
1922|168|A|Copyright(c) 2025 First Databank, Inc.||
1922|169|B|||
1923|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1923|002|Z|does NOT have all possible information about this product. This||
1923|003|Z|information does not assure that this product is safe, effective,||
1923|004|Z|or appropriate for you. This information is not individual||
1923|005|Z|medical advice and does not substitute for the advice of your||
1923|006|Z|health care professional. Always ask your health care||
1923|007|Z|professional for complete information about this product and your||
1923|008|Z|specific health needs.||
1923|009|B|||
1923|010|T|LEVONORGESTREL/ETHINYL ESTRADIOL/IRON - ORAL||
1923|011|F|(LEE-voe-nor-JES-trel/ETH-i-nil ES-tra-DYE-ol/EYE-urn)||
1923|012|B|||
1923|013|C|COMMON BRAND NAME(S): Balcoltra||
1923|014|B|||
1923|015|W|WARNING:  Smoking raises your risk of stroke, heart attack, blood||
1923|016|W|clots, and high blood pressure from hormonal birth control (such||
1923|017|W|as the pill, patch, ring). The risk of these serious problems||
1923|018|W|increases with age and with the number of cigarettes you smoke.||
1923|019|W|Do not smoke or use tobacco. Do not use this medication if you||
1923|020|W|smoke cigarettes/use tobacco and are over 35 years old.||
1923|021|W|   Accidental overdose of iron-containing products is a leading||
1923|022|W|cause of fatal poisoning in children younger than 6 years. Keep||
1923|023|W|this product out of reach of children. If overdose does occur,||
1923|024|W|get medical help right away or call a poison control center.||
1923|025|B|||
1923|026|U|USES:  This combination hormone medication is used to prevent||
1923|027|U|pregnancy. It contains 2 hormones: levonorgestrel (a progestin)||
1923|028|U|and ethinyl estradiol (an estrogen). There is a small amount of||
1923|029|U|iron in each of the 7 inactive tablets taken during the fourth||
1923|030|U|week. The inactive pills do not contain any hormones. These||
1923|031|U|tablets are meant to keep you in the habit of taking 1 tablet||
1923|032|U|each day and do not have enough iron to treat iron deficiency.||
1923|033|U|   Besides preventing pregnancy, birth control pills may make||
1923|034|U|your periods more regular, decrease blood loss and painful||
1923|035|U|periods, and decrease your risk of ovarian cysts.||
1923|036|U|   This medication does not protect against sexually transmitted||
1923|037|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
1923|038|U|an effective barrier method (latex or polyurethane condom/dental||
1923|039|U|dams) during sexual activity will help to decrease your risk of||
1923|040|U|infection.||
1923|041|B|||
1923|042|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
1923|043|H|your pharmacist before you start using this product and each time||
1923|044|H|you get a refill. The leaflet contains very important information||
1923|045|H|on when to take your pills and what to do if you miss a dose. If||
1923|046|H|you have any questions, ask your doctor or pharmacist.||
1923|047|H|   Take this medication by mouth as directed by your doctor,||
1923|048|H|usually once daily. Pick a time of day that is easy for you to||
1923|049|H|remember, and take your pill at the same time each day.||
1923|050|H|   The manufacturer directs to swallow this medication whole.||
1923|051|H|However, many similar drugs (immediate-release tablets) can be||
1923|052|H|split/crushed. Follow your doctor's directions on how to take||
1923|053|H|this medication.||
1923|054|H|   It is very important to keep taking this medication exactly as||
1923|055|H|prescribed by your doctor. Follow the package instructions to||
1923|056|H|find the first tablet, start with the first tablet in the pack,||
1923|057|H|and take them in the correct order. Do not skip any doses.||
1923|058|H|Pregnancy is more likely if you miss pills, start a new pack||
1923|059|H|late, or take your pill at a different time of the day than||
1923|060|H|usual.||
1923|061|H|   If you have vomiting or diarrhea within 4 hours after taking||
1923|062|H|your tablet, follow the directions in the Patient Information||
1923|063|H|Leaflet for what to do if you miss a dose. Vomiting or diarrhea||
1923|064|H|can prevent your birth control pills from working well. If||
1923|065|H|vomiting or diarrhea continues, use a backup birth control method||
1923|066|H|(such as condoms, spermicide) and check with your doctor or||
1923|067|H|pharmacist for more details.||
1923|068|H|   Taking this medication after your evening meal or at bedtime||
1923|069|H|may help if you have any stomach upset or nausea with the||
1923|070|H|medication. You may choose to take this medication at another||
1923|071|H|time of day that is easier for you to remember. No matter what||
1923|072|H|dosing schedule you use, it is very important that you take this||
1923|073|H|medication at the same time each day, 24 hours apart.||
1923|074|H|   Your pill pack contains 21 pills with active medication. It||
1923|075|H|also contains 7 reminder pills with iron. Take one active pill||
1923|076|H|(with hormones) once daily for 21 days in a row. Take one||
1923|077|H|inactive pill (with iron) once daily for 7 days in a row after||
1923|078|H|you have taken the last active pill unless otherwise directed by||
1923|079|H|your doctor. You should have your period during the fourth week||
1923|080|H|of the cycle. After you have taken the last iron tablet in the||
1923|081|H|pack, start a new pack the next day even if your period is||
1923|082|H|continuing or if you do not have your period. If you do not get||
1923|083|H|your period, consult your doctor.||
1923|084|H|   If this is the first time you are using this medication and||
1923|085|H|you are not switching from another form of hormonal birth control||
1923|086|H|(such as patch, other birth control pills), take the first tablet||
1923|087|H|in the pack on the first Sunday following the beginning of your||
1923|088|H|menstrual period or on the first day of your period. If your||
1923|089|H|period begins on a Sunday, begin taking this medication on that||
1923|090|H|day. For the first cycle of use only, use a backup form of||
1923|091|H|non-hormonal birth control (such as condoms, spermicide) for the||
1923|092|H|first 7 days to prevent pregnancy until the medication has enough||
1923|093|H|time to work. If you start on the first day of your period, you||
1923|094|H|do not need to use backup birth control the first week.||
1923|095|H|   Ask your doctor or pharmacist for information about how to||
1923|096|H|switch from other forms of hormonal birth control (such as patch,||
1923|097|H|other birth control pills) to this product. If any information is||
1923|098|H|unclear, consult the Patient Information Leaflet or your doctor||
1923|099|H|or pharmacist.||
1923|100|B|||
1923|101|S|SIDE EFFECTS:  Nausea, vomiting, headache, abdominal||
1923|102|S|cramps/bloating, breast tenderness, swelling of the ankles/feet||
1923|103|S|(retaining fluid), or weight change may occur. Vaginal bleeding||
1923|104|S|between periods (spotting) or missed/irregular periods may occur,||
1923|105|S|especially during the first few months of use. If any of these||
1923|106|S|effects last or get worse, tell your doctor or pharmacist||
1923|107|S|promptly. If you miss 2 periods in a row (or 1 period if the pill||
1923|108|S|has not been used properly), contact your doctor for a pregnancy||
1923|109|S|test.||
1923|110|S|   Remember that this medication has been prescribed because your||
1923|111|S|doctor has judged that the benefit to you is greater than the||
1923|112|S|risk of side effects. Many people using this medication do not||
1923|113|S|have serious side effects.||
1923|114|S|   This medication may raise your blood pressure. Check your||
1923|115|S|blood pressure regularly and tell your doctor if the results are||
1923|116|S|high.||
1923|117|S|   Tell your doctor right away if you have any serious side||
1923|118|S|effects, including: lumps in the breast, mental/mood changes||
1923|119|S|(such as new/worsening depression), severe stomach/abdominal||
1923|120|S|pain, unusual changes in vaginal bleeding (such as continuous||
1923|121|S|spotting, sudden heavy bleeding), symptoms of high blood sugar||
1923|122|S|(such as increased thirst/urination), dark urine, yellowing||
1923|123|S|eyes/skin.||
1923|124|S|   This medication may rarely cause serious (sometimes fatal)||
1923|125|S|problems from blood clots (such as heart attack, stroke, blood||
1923|126|S|clots in the lungs or legs). Get medical help right away if you||
1923|127|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1923|128|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
1923|129|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1923|130|S|trouble speaking, weakness on one side of the body, sudden vision||
1923|131|S|changes.||
1923|132|S|   A very serious allergic reaction to this drug is rare.||
1923|133|S|However, get medical help right away if you notice any symptoms||
1923|134|S|of a serious allergic reaction, including: rash, itching/swelling||
1923|135|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1923|136|S|breathing.||
1923|137|S|   This is not a complete list of possible side effects. If you||
1923|138|S|notice other effects not listed above, contact your doctor or||
1923|139|S|pharmacist.||
1923|140|S|   In the US -||
1923|141|S|   Call your doctor for medical advice about side effects. You||
1923|142|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1923|143|S|www.fda.gov/medwatch.||
1923|144|S|   In Canada - Call your doctor for medical advice about side||
1923|145|S|effects. You may report side effects to Health Canada at||
1923|146|S|1-866-234-2345.||
1923|147|B|||
1923|148|P|PRECAUTIONS:  See also Warning section.||
1923|149|P|   Before taking this medication, tell your doctor or pharmacist||
1923|150|P|if you are allergic to levonorgestrel, ethinyl estradiol, or iron||
1923|151|P|products; or to other estrogen or progestin products; or if you||
1923|152|P|have any other allergies. This product may contain inactive||
1923|153|P|ingredients, which can cause allergic reactions or other||
1923|154|P|problems. Talk to your pharmacist for more details.||
1923|155|P|   Before using this medication, tell your doctor or pharmacist||
1923|156|P|your medical history, especially of: blood clots (for example, in||
1923|157|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
1923|158|P|C or protein S deficiency), high blood pressure, abnormal breast||
1923|159|P|exam, cancer (especially endometrial or breast cancer), high||
1923|160|P|cholesterol or triglyceride (blood fat) levels, depression,||
1923|161|P|diabetes, family or personal history of a certain swelling||
1923|162|P|disorder (angioedema), gallbladder problems, severe||
1923|163|P|headaches/migraines, heart problems (such as heart valve disease,||
1923|164|P|irregular heartbeat, previous heart attack), history of yellowing||
1923|165|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
1923|166|P|birth control (such as pills, patch), kidney disease, liver||
1923|167|P|disease (including tumors), obesity, stroke, swelling (edema),||
1923|168|P|thyroid problems, unexplained vaginal bleeding.||
1923|169|P|   Tell your doctor if you just had or will be having surgery or||
1923|170|P|if you will be confined to a bed or chair for a long time (such||
1923|171|P|as a long plane flight). These conditions increase your risk of||
1923|172|P|getting blood clots, especially if you are using hormonal birth||
1923|173|P|control. You may need to stop this medication for a time or take||
1923|174|P|special precautions.||
1923|175|P|   This medication may cause blotchy, dark areas on your face and||
1923|176|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
1923|177|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
1923|178|P|wear protective clothing when outdoors.||
1923|179|P|   If you are nearsighted or wear contact lenses, you may develop||
1923|180|P|vision problems or trouble wearing your contact lenses. Contact||
1923|181|P|your eye doctor if these problems occur.||
1923|182|P|   It may take longer for you to become pregnant after you stop||
1923|183|P|taking birth control pills. Consult your doctor.||
1923|184|P|   This medication must not be used during pregnancy. If you||
1923|185|P|become pregnant or think you may be pregnant, tell your doctor||
1923|186|P|right away. If you have just given birth or had a pregnancy loss||
1923|187|P|or abortion after the first 3 months, talk with your doctor about||
1923|188|P|reliable forms of birth control, and find out when it is safe to||
1923|189|P|start using birth control that contains a form of estrogen, such||
1923|190|P|as this medication.||
1923|191|P|   A small amount of this medication passes into breast milk and||
1923|192|P|may have undesirable effects on a nursing infant. Consult your||
1923|193|P|doctor before breastfeeding.||
1923|194|B|||
1923|195|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1923|196|I|medications work or increase your risk for serious side effects.||
1923|197|I|This document does not contain all possible drug interactions.||
1923|198|I|Keep a list of all the products you use (including||
1923|199|I|prescription/nonprescription drugs and herbal products) and share||
1923|200|I|it with your doctor and pharmacist. Do not start, stop, or change||
1923|201|I|the dosage of any medicines without your doctor's approval.||
1923|202|I|   Some products that may interact with this drug are: aromatase||
1923|203|I|inhibitors (such as anastrozole, exemestane), fezolinetant,||
1923|204|I|ospemifene, tamoxifen, tizanidine, tranexamic acid.||
1923|205|I|   Some drugs may cause hormonal birth control to work less well||
1923|206|I|by decreasing the amount of birth control hormones in your body.||
1923|207|I|This effect can result in pregnancy. Examples include||
1923|208|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
1923|209|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
1923|210|I|seizures (such as barbiturates, carbamazepine, felbamate,||
1923|211|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
1923|212|I|nevirapine), among others.||
1923|213|I|   Tell your doctor when you start any new drug, and discuss if||
1923|214|I|you should use reliable backup birth control. Also tell your||
1923|215|I|doctor if you have any new spotting or breakthrough bleeding,||
1923|216|I|because these may be signs that your birth control is not working||
1923|217|I|well.||
1923|218|I|   The iron in the inactive pill can decrease the absorption of||
1923|219|I|certain drugs, especially if you take them around the same time.||
1923|220|I|These drugs include bisphosphonates (such as alendronate),||
1923|221|I|levodopa, penicillamine, quinolone antibiotics (such as||
1923|222|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
1923|223|I|doxycycline, minocycline), thyroid medications (such as||
1923|224|I|levothyroxine), among others. Ask your doctor or pharmacist if||
1923|225|I|you should throw away the inactive pills (iron tablets) each day||
1923|226|I|rather than taking them.||
1923|227|I|   This medication may interfere with certain lab tests (such as||
1923|228|I|blood tests for clotting factors, thyroid), possibly causing||
1923|229|I|false test results. Make sure lab personnel and all your doctors||
1923|230|I|know you use this medication.||
1923|231|B|||
1923|232|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1923|233|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1923|234|O|poison control center right away. US residents can call||
1923|235|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1923|236|O|Symptoms of overdose may include: severe nausea and vomiting,||
1923|237|O|sudden/unusual vaginal bleeding.||
1923|238|B|||
1923|239|N|NOTES:  Do not share this medication with others.||
1923|240|N|   You should have regular complete physical exams including||
1923|241|N|blood pressure, breast exam, pelvic exam, and screening for||
1923|242|N|cervical cancer (Pap smear). Follow your doctor's instructions||
1923|243|N|for examining your breasts, and report any lumps right away. Keep||
1923|244|N|all medical and lab appointments. Consult your doctor for more||
1923|245|N|details.||
1923|246|B|||
1923|247|D|MISSED DOSE:  Refer to the product package information for advice||
1923|248|D|on missed doses. You may need to use backup birth control (such||
1923|249|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
1923|250|D|pharmacist if you have any questions.||
1923|251|D|   If you often forget to take your pills as directed, contact||
1923|252|D|your doctor to discuss switching to another form of birth||
1923|253|D|control.||
1923|254|B|||
1923|255|R|STORAGE:  Store at room temperature away from light and moisture.||
1923|256|R|Do not store in the bathroom. Keep all medications away from||
1923|257|R|children and pets.||
1923|258|R|   Do not flush medications down the toilet or pour them into a||
1923|259|R|drain unless instructed to do so. Properly discard this product||
1923|260|R|when it is expired or no longer needed. Consult your pharmacist||
1923|261|R|or local waste disposal company.||
1923|262|B|||
1923|263|A|Information last revised October 2025.||
1923|264|A|Copyright(c) 2025 First Databank, Inc.||
1923|265|B|||
1924|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1924|002|Z|does NOT have all possible information about this product. This||
1924|003|Z|information does not assure that this product is safe, effective,||
1924|004|Z|or appropriate for you. This information is not individual||
1924|005|Z|medical advice and does not substitute for the advice of your||
1924|006|Z|health care professional. Always ask your health care||
1924|007|Z|professional for complete information about this product and your||
1924|008|Z|specific health needs.||
1924|009|B|||
1924|010|T|FOSTAMATINIB - ORAL||
1924|011|F|(FOS-ta-MA-ti-nib)||
1924|012|B|||
1924|013|C|COMMON BRAND NAME(S): Tavalisse||
1924|014|B|||
1924|015|U|USES:  This medication is used to treat people with a certain||
1924|016|U|blood disorder known as chronic immune thrombocytopenia-ITP. This||
1924|017|U|is a condition where the amount of one type of cell in your blood||
1924|018|U|(platelets) is lower than normal. ITP can lead to serious||
1924|019|U|bleeding problems. Fostamatinib belongs to a class of drugs known||
1924|020|U|as spleen tyrosine kinase inhibitors. It works by increasing||
1924|021|U|platelets in your blood.||
1924|022|B|||
1924|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1924|024|H|from your pharmacist before you start taking fostamatinib and||
1924|025|H|each time you get a refill. If you have any questions, ask your||
1924|026|H|doctor or pharmacist.||
1924|027|H|   Take this medication by mouth with or without food as directed||
1924|028|H|by your doctor, usually twice daily. The dosage is based on your||
1924|029|H|medical condition and response to treatment.||
1924|030|H|   Use this medication regularly to get the most benefit from it.||
1924|031|H|To help you remember, take it at the same times each day.||
1924|032|B|||
1924|033|S|SIDE EFFECTS:  Diarrhea is a common side effect. Tell your doctor||
1924|034|S|promptly if you have diarrhea. Ask your healthcare provider about||
1924|035|S|how to manage diarrhea, such as by changing your diet, taking||
1924|036|S|anti-diarrhea medicine, and drinking enough water to prevent||
1924|037|S|dehydration.||
1924|038|S|   Nausea, upset stomach, abdominal pain, dizziness, or tiredness||
1924|039|S|may also occur. If any of these effects last or get worse, tell||
1924|040|S|your doctor or pharmacist promptly.||
1924|041|S|   This medication may cause or worsen high blood pressure. Your||
1924|042|S|blood pressure should be checked regularly. Your doctor may start||
1924|043|S|or adjust medication(s) to treat high blood pressure.||
1924|044|S|   Remember that this medication has been prescribed because your||
1924|045|S|doctor has judged that the benefit to you is greater than the||
1924|046|S|risk of side effects. Many people using this medication do not||
1924|047|S|have serious side effects.||
1924|048|S|   Tell your doctor right away if you have any serious side||
1924|049|S|effects, including: bruising/bleeding.||
1924|050|S|   Fostamatinib may rarely cause serious (possibly fatal) liver||
1924|051|S|disease. Get medical help right away if you have any symptoms of||
1924|052|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
1924|053|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1924|054|S|urine.||
1924|055|S|   This medication may lower your ability to fight infections.||
1924|056|S|This may make you more likely to get a serious (rarely fatal)||
1924|057|S|infection or make any infection you have worse. Tell your doctor||
1924|058|S|right away if you have any signs of infection (such as sore||
1924|059|S|throat that doesn't go away, fever, chills).||
1924|060|S|   A very serious allergic reaction to this drug is rare.||
1924|061|S|However, get medical help right away if you notice any symptoms||
1924|062|S|of a serious allergic reaction, including: rash, itching/swelling||
1924|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1924|064|S|breathing.||
1924|065|S|   This is not a complete list of possible side effects. If you||
1924|066|S|notice other effects not listed above, contact your doctor or||
1924|067|S|pharmacist.||
1924|068|S|   In the US -||
1924|069|S|   Call your doctor for medical advice about side effects. You||
1924|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1924|071|S|www.fda.gov/medwatch.||
1924|072|S|   In Canada - Call your doctor for medical advice about side||
1924|073|S|effects. You may report side effects to Health Canada at||
1924|074|S|1-866-234-2345.||
1924|075|B|||
1924|076|P|PRECAUTIONS:  Before taking fostamatinib, tell your doctor or||
1924|077|P|pharmacist if you are allergic to it; or if you have any other||
1924|078|P|allergies. This product may contain inactive ingredients, which||
1924|079|P|can cause allergic reactions or other problems. Talk to your||
1924|080|P|pharmacist for more details.||
1924|081|P|   Before using this medication, tell your doctor or pharmacist||
1924|082|P|your medical history, especially of: high blood pressure, liver||
1924|083|P|problems, surgery to remove spleen, bleeding/blood problems (such||
1924|084|P|as blood clots).||
1924|085|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1924|086|P|can make you more dizzy. Do not drive, use machinery, or do||
1924|087|P|anything that needs alertness until you can do it safely. Limit||
1924|088|P|alcoholic beverages. Talk to your doctor if you are using||
1924|089|P|marijuana (cannabis).||
1924|090|P|   Fostamatinib can make you more likely to get infections or may||
1924|091|P|make current infections worse. Stay away from anyone who has an||
1924|092|P|infection that may easily spread (such as chickenpox, COVID-19,||
1924|093|P|measles, flu). Talk to your doctor if you have been exposed to an||
1924|094|P|infection or for more details.||
1924|095|P|   Tell your health care professional that you are using||
1924|096|P|fostamatinib before having any immunizations/vaccinations. Avoid||
1924|097|P|contact with people who have recently received live vaccines||
1924|098|P|(such as flu vaccine inhaled through the nose).||
1924|099|P|   Before having surgery, tell your doctor or dentist about all||
1924|100|P|the products you use (including prescription drugs,||
1924|101|P|nonprescription drugs, and herbal products).||
1924|102|P|   Older adults may be more sensitive to the side effects of this||
1924|103|P|drug, especially high blood pressure.||
1924|104|P|   Tell your doctor if you are pregnant or plan to become||
1924|105|P|pregnant. You should not become pregnant while using||
1924|106|P|fostamatinib. Fostamatinib may harm an unborn baby. Ask about||
1924|107|P|reliable forms of birth control while using this medication and||
1924|108|P|for at least 1 month after the last dose. If you become pregnant,||
1924|109|P|talk to your doctor right away about the risks and benefits of||
1924|110|P|this medication.||
1924|111|P|   It is unknown if this medication passes into breast milk.||
1924|112|P|Because of the possible risk to the infant, breastfeeding is not||
1924|113|P|recommended while using this medication and for at least 1 month||
1924|114|P|after the last dose. Consult your doctor before breastfeeding.||
1924|115|B|||
1924|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1924|117|I|medications work or increase your risk for serious side effects.||
1924|118|I|This document does not contain all possible drug interactions.||
1924|119|I|Keep a list of all the products you use (including||
1924|120|I|prescription/nonprescription drugs and herbal products) and share||
1924|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
1924|122|I|the dosage of any medicines without your doctor's approval.||
1924|123|I|   Other medications can affect the removal of fostamatinib from||
1924|124|I|your body, which may affect how fostamatinib works. Examples||
1924|125|I|include azole antifungals (such as ketoconazole/itraconazole),||
1924|126|I|rifamycins (such as rifampin/rifampicin), St. John's wort, drugs||
1924|127|I|used to treat seizures (such as carbamazepine, phenytoin), among||
1924|128|I|others.||
1924|129|B|||
1924|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1924|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1924|132|O|poison control center right away. US residents can call||
1924|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1924|134|B|||
1924|135|N|NOTES:  Do not share this medication with others.||
1924|136|N|   Lab and/or medical tests (such as complete blood count, liver||
1924|137|N|function, blood pressure) should be done while you are taking||
1924|138|N|this medication. Keep all medical and lab appointments.||
1924|139|B|||
1924|140|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1924|141|D|next dose at the regular time. Do not double the dose to catch||
1924|142|D|up.||
1924|143|B|||
1924|144|R|STORAGE:  Store in the original bottle at room temperature away||
1924|145|R|from light and moisture. Do not store in the bathroom. Keep the||
1924|146|R|drying agent (desiccant) in the bottle. Some brands of this||
1924|147|R|medication should be used within 60 days of opening the bottle.||
1924|148|R|Check the product package or ask your pharmacist about your||
1924|149|R|specific brand. Keep all medications away from children and pets.||
1924|150|R|   Do not flush medications down the toilet or pour them into a||
1924|151|R|drain unless instructed to do so. Properly discard this product||
1924|152|R|when it is expired or no longer needed. Consult your pharmacist||
1924|153|R|or local waste disposal company.||
1924|154|B|||
1924|155|M|MEDICAL ALERT:  Your condition can cause complications in a||
1924|156|M|medical emergency. For information about enrolling in MedicAlert,||
1924|157|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1924|158|B|||
1924|159|A|Information last revised April 2025.||
1924|160|A|Copyright(c) 2025 First Databank, Inc.||
1924|161|B|||
1925|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1925|002|Z|does NOT have all possible information about this product. This||
1925|003|Z|information does not assure that this product is safe, effective,||
1925|004|Z|or appropriate for you. This information is not individual||
1925|005|Z|medical advice and does not substitute for the advice of your||
1925|006|Z|health care professional. Always ask your health care||
1925|007|Z|professional for complete information about this product and your||
1925|008|Z|specific health needs.||
1925|009|B|||
1925|010|T|FOSNETUPITANT/PALONOSETRON - INJECTION||
1925|011|F|(FOS-net-UE-pi-tant/PAL-oh-NOE-se-tron)||
1925|012|B|||
1925|013|C|COMMON BRAND NAME(S): Akynzeo||
1925|014|B|||
1925|015|U|USES:  This product is a combination of 2 medications:||
1925|016|U|fosnetupitant and palonosetron. It is used to prevent nausea and||
1925|017|U|vomiting caused by cancer drug treatment (chemotherapy).||
1925|018|U|Fosnetupitant and palonosetron work by blocking natural||
1925|019|U|substances in the body (such as substance P/neurokinin 1,||
1925|020|U|serotonin) that cause vomiting.||
1925|021|B|||
1925|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1925|023|H|from your pharmacist before you start using this medication and||
1925|024|H|each time you get a refill. If you have any questions, ask your||
1925|025|H|doctor or pharmacist.||
1925|026|H|   This medication is given by injection into a vein by a health||
1925|027|H|care professional. It is given as directed by your doctor,||
1925|028|H|usually 30 minutes before the start of chemotherapy.||
1925|029|H|   The dosage is based on your medical condition and response to||
1925|030|H|treatment.||
1925|031|H|   Tell your doctor if you have nausea or vomiting.||
1925|032|B|||
1925|033|S|SIDE EFFECTS:  Pain, redness, or swelling at the injection site||
1925|034|S|may occur. Headache, tiredness, or weakness may also occur. If||
1925|035|S|any of these effects last or get worse, tell your doctor or||
1925|036|S|pharmacist promptly.||
1925|037|S|   Remember that this medication has been prescribed because your||
1925|038|S|doctor has judged that the benefit to you is greater than the||
1925|039|S|risk of side effects. Many people using this medication do not||
1925|040|S|have serious side effects.||
1925|041|S|   This medication may increase serotonin and rarely cause a very||
1925|042|S|serious condition called serotonin syndrome/toxicity. The risk||
1925|043|S|increases if you are also taking other drugs that increase||
1925|044|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
1925|045|S|take (see Drug Interactions section). Get medical help right away||
1925|046|S|if you develop some of the following symptoms: fast heartbeat,||
1925|047|S|hallucinations, loss of coordination, severe dizziness, severe||
1925|048|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
1925|049|S|unusual agitation/restlessness.||
1925|050|S|   A very serious allergic reaction to this drug is rare.||
1925|051|S|However, get medical help right away if you notice any symptoms||
1925|052|S|of a serious allergic reaction, including: rash, itching/swelling||
1925|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1925|054|S|breathing.||
1925|055|S|   This is not a complete list of possible side effects. If you||
1925|056|S|notice other effects not listed above, contact your doctor or||
1925|057|S|pharmacist.||
1925|058|S|   In the US -||
1925|059|S|   Call your doctor for medical advice about side effects. You||
1925|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1925|061|S|www.fda.gov/medwatch.||
1925|062|S|   In Canada - Call your doctor for medical advice about side||
1925|063|S|effects. You may report side effects to Health Canada at||
1925|064|S|1-866-234-2345.||
1925|065|B|||
1925|066|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1925|067|P|pharmacist if you are allergic to fosnetupitant or palonosetron;||
1925|068|P|or to netupitant; or to other anti-nausea serotonin blockers||
1925|069|P|(such as ondansetron, granisetron); or if you have any other||
1925|070|P|allergies. This product may contain inactive ingredients, which||
1925|071|P|can cause allergic reactions or other problems. Talk to your||
1925|072|P|pharmacist for more details.||
1925|073|P|   Before using this medication, tell your doctor or pharmacist||
1925|074|P|your medical history, especially of: kidney disease, liver||
1925|075|P|disease.||
1925|076|P|   Before having surgery, tell your doctor or dentist about all||
1925|077|P|the products you use (including prescription drugs,||
1925|078|P|nonprescription drugs, and herbal products).||
1925|079|P|   During pregnancy, this medication should be used only when||
1925|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
1925|081|P|   It is unknown if this medication passes into breast milk.||
1925|082|P|Consult your doctor before breastfeeding.||
1925|083|B|||
1925|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1925|085|I|medications work or increase your risk for serious side effects.||
1925|086|I|This document does not contain all possible drug interactions.||
1925|087|I|Keep a list of all the products you use (including||
1925|088|I|prescription/nonprescription drugs and herbal products) and share||
1925|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
1925|090|I|the dosage of any medicines without your doctor's approval.||
1925|091|I|   This medication can slow down the removal of other medications||
1925|092|I|from your body, which may affect how they work. Examples of||
1925|093|I|affected drugs include elacestrant, flibanserin, lomitapide,||
1925|094|I|among others.||
1925|095|I|   Other medications can affect the removal of this product from||
1925|096|I|your body, which may affect how it works. Examples include||
1925|097|I|rifamycins (such as rifampin), St. John's wort, among others.||
1925|098|I|   The risk of serotonin syndrome/toxicity increases if you are||
1925|099|I|also taking other drugs that increase serotonin. Examples include||
1925|100|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
1925|101|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
1925|102|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
1925|103|I|serotonin syndrome/toxicity may be more likely when you start or||
1925|104|I|increase the dose of these drugs.||
1925|105|B|||
1925|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1925|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1925|108|O|poison control center right away. US residents can call||
1925|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1925|110|B|||
1925|111|N|NOTES:  Not applicable.||
1925|112|B|||
1925|113|D|MISSED DOSE:  It is important to get each dose of this medication||
1925|114|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1925|115|D|right away for a new dosing schedule. Do not double the dose to||
1925|116|D|catch up.||
1925|117|B|||
1925|118|R|STORAGE:  Not applicable. This medication is given in a hospital||
1925|119|R|or clinic or doctor's office and will not be stored at home.||
1925|120|B|||
1925|121|A|Information last revised May 2024.||
1925|122|A|Copyright(c) 2025 First Databank, Inc.||
1925|123|B|||
1926|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1926|002|Z|does NOT have all possible information about this product. This||
1926|003|Z|information does not assure that this product is safe, effective,||
1926|004|Z|or appropriate for you. This information is not individual||
1926|005|Z|medical advice and does not substitute for the advice of your||
1926|006|Z|health care professional. Always ask your health care||
1926|007|Z|professional for complete information about this product and your||
1926|008|Z|specific health needs.||
1926|009|B|||
1926|010|T|RITONAVIR POWDER PACKET - ORAL||
1926|011|F|(ri-TON-na-vir)||
1926|012|B|||
1926|013|C|COMMON BRAND NAME(S): Norvir||
1926|014|B|||
1926|015|W|WARNING:  Ritonavir may interact with many different types of||
1926|016|W|medicines, in some cases causing severe (sometimes fatal)||
1926|017|W|reactions. Consult your doctor or pharmacist about which||
1926|018|W|medications should not be taken with ritonavir. (See also Drug||
1926|019|W|Interactions section.)||
1926|020|B|||
1926|021|U|USES:  This drug is used with other HIV medications to help||
1926|022|U|control HIV infection. It helps to decrease the amount of HIV in||
1926|023|U|your body so your immune system can work better. This lowers your||
1926|024|U|chance of getting HIV complications (such as new infections,||
1926|025|U|cancer) and improves your quality of life.||
1926|026|U|   Ritonavir belongs to a class of drugs known as protease||
1926|027|U|inhibitors. It increases ("boosts") the levels of other protease||
1926|028|U|inhibitors, which helps these medications work better.||
1926|029|U|   Ritonavir is not a cure for HIV infection. To decrease your||
1926|030|U|risk of spreading HIV disease to others, continue to take all HIV||
1926|031|U|medications exactly as prescribed by your doctor. Use an||
1926|032|U|effective barrier method (latex or polyurethane condoms/dental||
1926|033|U|dams) during sexual activity as directed by your doctor. Do not||
1926|034|U|share personal items (such as needles/syringes, toothbrushes, and||
1926|035|U|razors) that may have contacted blood or other body fluids.||
1926|036|U|Consult your doctor or pharmacist for more details.||
1926|037|B|||
1926|038|V|OTHER USES:  This section contains uses of this drug that are not||
1926|039|V|listed in the approved professional labeling for the drug but||
1926|040|V|that may be prescribed by your health care professional. Use this||
1926|041|V|drug for a condition that is listed in this section only if it||
1926|042|V|has been so prescribed by your health care professional.||
1926|043|V|   This product may also be used to lessen the risk of HIV||
1926|044|V|infection after contact with the virus (for example, due to a||
1926|045|V|needle stick). Ask your doctor for more details.||
1926|046|B|||
1926|047|H|HOW TO USE:  Read the Patient Information Leaflet and||
1926|048|H|Instructions for Use if available from your pharmacist before you||
1926|049|H|start taking ritonavir and each time you get a refill. If you||
1926|050|H|have any questions, ask your doctor or pharmacist.||
1926|051|H|   Take this medication by mouth with a meal as directed by your||
1926|052|H|doctor, usually 1 to 2 times daily. Take ritonavir at the same||
1926|053|H|time(s) as your other protease inhibitor. Open the packet and mix||
1926|054|H|the powder with soft food (such as applesauce, vanilla pudding)||
1926|055|H|or liquid (such as water, infant formula, milk) as directed. If||
1926|056|H|giving through a feeding tube, the powder should be mixed with||
1926|057|H|water. The dose of the medication should be taken within 2 hours||
1926|058|H|after mixing.||
1926|059|H|   The dosage is based on your medical condition, response to||
1926|060|H|treatment, and other medications you may be taking. Be sure to||
1926|061|H|tell your doctor and pharmacist about all the products you use||
1926|062|H|(including prescription drugs, nonprescription drugs, and herbal||
1926|063|H|products). Children's dosage may also be based on body size.||
1926|064|H|   For the best effect, take this medication at evenly spaced||
1926|065|H|times. To help you remember, take this medication at the same||
1926|066|H|time(s) every day.||
1926|067|H|   It is very important to keep taking this medication (and other||
1926|068|H|HIV medications) exactly as prescribed by your doctor. Do not||
1926|069|H|take more or less of this drug than prescribed or stop taking it||
1926|070|H|(or other HIV medicines) even for a short time unless directed to||
1926|071|H|do so by your doctor. Doing so may cause the amount of virus to||
1926|072|H|increase, make the infection more difficult to treat (resistant),||
1926|073|H|or worsen side effects.||
1926|074|B|||
1926|075|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, heartburn, stomach||
1926|076|S|pain, dizziness, tiredness, weakness, changes in taste, or||
1926|077|S|tingling/numbness of the mouth area may occur. If any of these||
1926|078|S|effects last or get worse, tell your doctor or pharmacist||
1926|079|S|promptly.||
1926|080|S|   Remember that this medication has been prescribed because your||
1926|081|S|doctor has judged that the benefit to you is greater than the||
1926|082|S|risk of side effects. Many people using this medication do not||
1926|083|S|have serious side effects.||
1926|084|S|   As your immune system gets stronger, it can begin to fight off||
1926|085|S|infections you already had, possibly causing disease symptoms to||
1926|086|S|come back. You could also have symptoms if your immune system||
1926|087|S|becomes overactive. This reaction may happen at any time (soon||
1926|088|S|after starting HIV treatment or many months later). Tell your||
1926|089|S|doctor right away if you have any serious symptoms, including:||
1926|090|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1926|091|S|that doesn't go away, headaches that are severe or don't go away,||
1926|092|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1926|093|S|changes, signs of infection (such as sore throat that doesn't go||
1926|094|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1926|095|S|sores), signs of an overactive thyroid (such as irritability,||
1926|096|S|nervousness, heat intolerance, fast/pounding/irregular||
1926|097|S|heartbeat).||
1926|098|S|   Tell your doctor right away if you have any serious side||
1926|099|S|effects, including: nausea/vomiting that doesn't stop,||
1926|100|S|stomach/abdominal pain, yellowing eyes/skin, dark urine, loss of||
1926|101|S|appetite, mental/mood changes (such as depression, anxiety),||
1926|102|S|increased thirst/urination.||
1926|103|S|   Get medical help right away if you have any very serious side||
1926|104|S|effects, including: symptoms of a heart attack (such as||
1926|105|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
1926|106|S|easy bruising/bleeding, fainting, fast/irregular heartbeat.||
1926|107|S|   Changes in body fat may occur while you are taking this||
1926|108|S|medication (such as increased fat in the upper back and stomach||
1926|109|S|areas, decreased fat in the arms and legs). The cause and||
1926|110|S|long-term effects of these changes are unknown. Discuss the risks||
1926|111|S|and benefits of treatment with your doctor, as well as the||
1926|112|S|possible use of exercise to reduce this side effect.||
1926|113|S|   A very serious allergic reaction to this drug is rare.||
1926|114|S|However, get medical help right away if you notice any symptoms||
1926|115|S|of a serious allergic reaction, including: rash, itching/swelling||
1926|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1926|117|S|breathing.||
1926|118|S|   This is not a complete list of possible side effects. If you||
1926|119|S|notice other effects not listed above, contact your doctor or||
1926|120|S|pharmacist.||
1926|121|S|   In the US -||
1926|122|S|   Call your doctor for medical advice about side effects. You||
1926|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1926|124|S|www.fda.gov/medwatch.||
1926|125|S|   In Canada - Call your doctor for medical advice about side||
1926|126|S|effects. You may report side effects to Health Canada at||
1926|127|S|1-866-234-2345.||
1926|128|B|||
1926|129|P|PRECAUTIONS:  Before taking ritonavir, tell your doctor or||
1926|130|P|pharmacist if you are allergic to it; or if you have any other||
1926|131|P|allergies. This product may contain inactive ingredients, which||
1926|132|P|can cause allergic reactions or other problems. Talk to your||
1926|133|P|pharmacist for more details.||
1926|134|P|   Before using this medication, tell your doctor or pharmacist||
1926|135|P|your medical history, especially of: diabetes, heart problems||
1926|136|P|(coronary artery disease, heart attack), hemophilia, high||
1926|137|P|cholesterol/triglycerides, gout/high uric acid in the blood,||
1926|138|P|liver problems (such as hepatitis B, hepatitis C), pancreatitis.||
1926|139|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1926|140|P|can make you more dizzy. Do not drive, use machinery, or do||
1926|141|P|anything that needs alertness until you can do it safely. Limit||
1926|142|P|alcoholic beverages. Talk to your doctor if you are using||
1926|143|P|marijuana (cannabis).||
1926|144|P|   If you have diabetes, this product may increase your blood||
1926|145|P|sugar. Check your blood sugar regularly as directed and share the||
1926|146|P|results with your doctor. Tell your doctor right away if you have||
1926|147|P|symptoms of high blood sugar such as increased thirst/urination.||
1926|148|P|Your doctor may need to adjust your diabetes medication, exercise||
1926|149|P|program, or diet.||
1926|150|P|   Before having surgery, tell your doctor or dentist about all||
1926|151|P|the products you use (including prescription drugs,||
1926|152|P|nonprescription drugs, and herbal products).||
1926|153|P|   Tell your doctor if you are pregnant before using this||
1926|154|P|medication. Treatment can lower the risk of passing HIV infection||
1926|155|P|to your baby. Discuss the risks and benefits with your doctor.||
1926|156|P|   This medication passes into breast milk. Because breast milk||
1926|157|P|may transmit HIV, consult your doctor before breastfeeding.||
1926|158|B|||
1926|159|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1926|160|I|medications work or increase your risk for serious side effects.||
1926|161|I|This document does not contain all possible drug interactions.||
1926|162|I|Keep a list of all the products you use (including||
1926|163|I|prescription/nonprescription drugs and herbal products) and share||
1926|164|I|it with your doctor and pharmacist. Do not start, stop, or change||
1926|165|I|the dosage of any medicines without your doctor's approval.||
1926|166|I|   Ritonavir interacts with many medications. Some products that||
1926|167|I|may interact with this drug are: cobicistat, orlistat.||
1926|168|I|   Ritonavir can slow down or speed up the removal of other||
1926|169|I|medications from your body, which may affect how they work.||
1926|170|I|Examples of affected drugs include alfuzosin, antiarrhythmics||
1926|171|I|(such as amiodarone, dronedarone, flecainide, propafenone,||
1926|172|I|quinidine), certain benzodiazepines (midazolam, triazolam),||
1926|173|I|certain "blood thinners" (such as rivaroxaban, warfarin),||
1926|174|I|eletriptan, drugs to treat erectile dysfunction-ED or pulmonary||
1926|175|I|hypertension (such as avanafil, sildenafil), ergot alkaloids||
1926|176|I|(such as dihydroergotamine, ergotamine, methylergonovine),||
1926|177|I|lurasidone, certain opioid pain medications (such as fentanyl,||
1926|178|I|meperidine), pimozide, ranolazine, salmeterol, "statin"||
1926|179|I|cholesterol drugs (such as simvastatin, lovastatin), among||
1926|180|I|others.||
1926|181|I|   Other medications can affect the removal of ritonavir from||
1926|182|I|your body, which may affect how ritonavir works. Examples include||
1926|183|I|apalutamide, rifampin, St. John's wort, among others.||
1926|184|I|   This medication may decrease the effectiveness of hormonal||
1926|185|I|birth control such as pills, patch, or ring. This could cause||
1926|186|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1926|187|I|use reliable backup birth control methods while using this||
1926|188|I|medication. Also tell your doctor if you have any new spotting or||
1926|189|I|breakthrough bleeding, because these may be signs that your birth||
1926|190|I|control is not working well.||
1926|191|B|||
1926|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1926|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1926|194|O|poison control center right away. US residents can call||
1926|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1926|196|B|||
1926|197|N|NOTES:  Do not share this medication with others.||
1926|198|N|   Lab and/or medical tests (such as liver function, viral load,||
1926|199|N|T-cell counts, blood sugar, triglycerides/cholesterol) should be||
1926|200|N|done while you are taking this medication. Keep all medical and||
1926|201|N|lab appointments. Consult your doctor for more details.||
1926|202|B|||
1926|203|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1926|204|D|remember. If it is near the time of the next dose, skip the||
1926|205|D|missed dose. Take your next dose at the regular time. Do not||
1926|206|D|double the dose to catch up.||
1926|207|B|||
1926|208|R|STORAGE:  Store at room temperature. Do not store in the||
1926|209|R|bathroom. Keep all medications away from children and pets.||
1926|210|R|   Do not flush medications down the toilet or pour them into a||
1926|211|R|drain unless instructed to do so. Properly discard this product||
1926|212|R|when it is expired or no longer needed. Consult your pharmacist||
1926|213|R|or local waste disposal company.||
1926|214|B|||
1926|215|A|Information last revised April 2025.||
1926|216|A|Copyright(c) 2025 First Databank, Inc.||
1926|217|B|||
1928|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1928|002|Z|does NOT have all possible information about this product. This||
1928|003|Z|information does not assure that this product is safe, effective,||
1928|004|Z|or appropriate for you. This information is not individual||
1928|005|Z|medical advice and does not substitute for the advice of your||
1928|006|Z|health care professional. Always ask your health care||
1928|007|Z|professional for complete information about this product and your||
1928|008|Z|specific health needs.||
1928|009|B|||
1928|010|T|METHOXYFLURANE - INHALATION||
1928|011|F|(meth-OX-ee-FLUR-ane)||
1928|012|B|||
1928|013|W|WARNING:  This medication may rarely cause kidney or liver||
1928|014|W|damage. To decrease your risk, carefully follow your health care||
1928|015|W|provider's directions for how to use this medication. Tell your||
1928|016|W|doctor right away if you have symptoms of kidney damage (such as||
1928|017|W|change in amount of urine) or liver damage (such as||
1928|018|W|nausea/vomiting that doesn't stop, loss of appetite,||
1928|019|W|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1928|020|B|||
1928|021|U|USES:  This medication is used for the short-term relief of||
1928|022|U|moderate to severe pain after trauma or during certain medical||
1928|023|U|procedures. It should not be used for relief of pain that keeps||
1928|024|U|coming back or that is ongoing (such as for chronic back pain).||
1928|025|U|It is not clearly known how it works to reduce pain, but it may||
1928|026|U|affect certain natural substances in your body. Methoxyflurane||
1928|027|U|belongs to a class of drugs known as inhalation anesthetics.||
1928|028|U|   This form of methoxyflurane is not used for anesthesia during||
1928|029|U|surgery.||
1928|030|B|||
1928|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1928|032|H|from your pharmacist before you start using methoxyflurane and||
1928|033|H|each time you get a refill. If you have any questions, ask your||
1928|034|H|doctor or pharmacist.||
1928|035|H|   A health care professional will help you with how to use the||
1928|036|H|inhaler. Breathe in and out through the mouthpiece of the inhaler||
1928|037|H|as directed by your doctor. Continue breathing in and out through||
1928|038|H|the inhaler until you start to feel pain relief. You may begin to||
1928|039|H|feel pain relief after about 6 to 10 breaths, or within about 5||
1928|040|H|minutes. If you need stronger pain relief, inhale and use your||
1928|041|H|finger to cover the dilutor hole on the inhaler as directed. You||
1928|042|H|do not need to breathe in and out of the inhaler all of the time.||
1928|043|H|Continue to take breaths through the inhaler from time to time,||
1928|044|H|as needed to control your pain.||
1928|045|H|   The dosage is based on your medical condition and response to||
1928|046|H|treatment. Use the lowest possible dose to get pain relief.||
1928|047|H|Properly stop the medication when so directed.||
1928|048|H|   Though it helps many people, this medication may sometimes||
1928|049|H|cause addiction. This risk may be higher if you have a substance||
1928|050|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1928|051|H|Use this medication exactly as prescribed to lower the risk of||
1928|052|H|addiction. Ask your doctor or pharmacist for more details.||
1928|053|H|   Tell your doctor if your pain lasts or gets worse.||
1928|054|B|||
1928|055|S|SIDE EFFECTS:  See also Warning section.||
1928|056|S|   Dizziness, headache, or drowsiness may occur. Mental/mood||
1928|057|S|changes such as trouble with thinking or coordination, feeling||
1928|058|S|"high," or temporary memory problems may also occur. If any of||
1928|059|S|these effects last or get worse, tell your doctor or pharmacist||
1928|060|S|promptly.||
1928|061|S|   Remember that this medication has been prescribed because your||
1928|062|S|doctor has judged that the benefit to you is greater than the||
1928|063|S|risk of side effects. Many people using this medication do not||
1928|064|S|have serious side effects.||
1928|065|S|   A very serious allergic reaction to this drug is rare.||
1928|066|S|However, get medical help right away if you notice any symptoms||
1928|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1928|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1928|069|S|breathing.||
1928|070|S|   This is not a complete list of possible side effects. If you||
1928|071|S|notice other effects not listed above, contact your doctor or||
1928|072|S|pharmacist.||
1928|073|S|   In the US -||
1928|074|S|   Call your doctor for medical advice about side effects. You||
1928|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1928|076|S|www.fda.gov/medwatch.||
1928|077|S|   In Canada - Call your doctor for medical advice about side||
1928|078|S|effects. You may report side effects to Health Canada at||
1928|079|S|1-866-234-2345.||
1928|080|B|||
1928|081|P|PRECAUTIONS:  Before using methoxyflurane, tell your doctor or||
1928|082|P|pharmacist if you are allergic to it; or to other inhaled||
1928|083|P|anesthetics; or if you have any other allergies. This product may||
1928|084|P|contain inactive ingredients, which can cause allergic reactions||
1928|085|P|or other problems. Talk to your pharmacist for more details.||
1928|086|P|   Before using this medication, tell your doctor or pharmacist||
1928|087|P|your medical history, especially of: breathing problems (such as||
1928|088|P|asthma, chronic obstructive pulmonary disease-COPD), diabetes,||
1928|089|P|kidney problems, liver problems, high or low blood pressure,||
1928|090|P|personal or family history of severe allergic reaction to inhaled||
1928|091|P|anesthetic, previous use of methoxyflurane, substance use||
1928|092|P|disorder (such as overuse of or addiction to drugs/alcohol).||
1928|093|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1928|094|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1928|095|P|machinery, or do anything that needs alertness until you can do||
1928|096|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1928|097|P|are using marijuana (cannabis).||
1928|098|P|   Before having surgery, tell your doctor or dentist about all||
1928|099|P|the products you use (including prescription drugs,||
1928|100|P|nonprescription drugs, and herbal products).||
1928|101|P|   During pregnancy, this medication should be used only when||
1928|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
1928|103|P|   It is unknown if this medication passes into breast milk.||
1928|104|P|Consult your doctor before breastfeeding.||
1928|105|B|||
1928|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1928|107|I|medications work or increase your risk for serious side effects.||
1928|108|I|This document does not contain all possible drug interactions.||
1928|109|I|Keep a list of all the products you use (including||
1928|110|I|prescription/nonprescription drugs and herbal products) and share||
1928|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
1928|112|I|the dosage of any medicines without your doctor's approval.||
1928|113|B|||
1928|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1928|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1928|116|O|poison control center right away. US residents can call||
1928|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1928|118|B|||
1928|119|N|NOTES:  Do not share this medication with others.||
1928|120|B|||
1928|121|D|MISSED DOSE:  Not applicable.||
1928|122|B|||
1928|123|R|STORAGE:  Not applicable. This product is used in a hospital or||
1928|124|R|clinic or doctor's office and will not be stored at home.||
1928|125|R|   Do not flush medications down the toilet or pour them into a||
1928|126|R|drain unless instructed to do so. Properly discard this product||
1928|127|R|when it is expired or no longer needed. Consult your pharmacist||
1928|128|R|or local waste disposal company.||
1928|129|B|||
1928|130|A|Information last revised March 2025.||
1928|131|A|Copyright(c) 2025 First Databank, Inc.||
1928|132|B|||
1929|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1929|002|Z|does NOT have all possible information about this product. This||
1929|003|Z|information does not assure that this product is safe, effective,||
1929|004|Z|or appropriate for you. This information is not individual||
1929|005|Z|medical advice and does not substitute for the advice of your||
1929|006|Z|health care professional. Always ask your health care||
1929|007|Z|professional for complete information about this product and your||
1929|008|Z|specific health needs.||
1929|009|B|||
1929|010|T|ERENUMAB - SUBCUTANEOUS INJECTION||
1929|011|F|(e-REN-ue-mab)||
1929|012|B|||
1929|013|C|COMMON BRAND NAME(S): Aimovig||
1929|014|B|||
1929|015|U|USES:  This medication is used to help prevent migraine. This||
1929|016|U|medication may work by changing the amounts of certain natural||
1929|017|U|substances in the brain. Erenumab belongs to a class of drugs||
1929|018|U|known as monoclonal antibodies. Preventing frequent migraine||
1929|019|U|attacks can help improve your ability to concentrate and do your||
1929|020|U|usual tasks.||
1929|021|B|||
1929|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
1929|023|H|Instructions for Use if available from your pharmacist before you||
1929|024|H|start using this medication and each time you get a refill. Ask||
1929|025|H|your health care professional how to prepare and use this||
1929|026|H|medication. If you have any questions, ask your doctor or||
1929|027|H|pharmacist.||
1929|028|H|   Inject this medication under the skin as directed by your||
1929|029|H|doctor, usually 1 time each month. The injection is given in the||
1929|030|H|upper arms, thighs, or abdomen (except for a 2-inch area around||
1929|031|H|your belly button). The dosage is based on your medical condition||
1929|032|H|and response to treatment.||
1929|033|H|   For a more comfortable injection, take the medication out of||
1929|034|H|the refrigerator at least 30 minutes before you inject it to||
1929|035|H|allow it to reach room temperature. Do not warm up this||
1929|036|H|medication any other way (for example, do not heat it in the||
1929|037|H|microwave, place it in hot water, or leave it in direct||
1929|038|H|sunlight). Do not shake the medication. Before using, check this||
1929|039|H|product for particles or discoloration. If either is present, do||
1929|040|H|not use the liquid. Before injecting each dose, clean the skin||
1929|041|H|you are going to inject into (the injection site) with rubbing||
1929|042|H|alcohol. Change the injection site each time to lessen injury||
1929|043|H|under the skin. Do not inject into skin that is tender, bruised,||
1929|044|H|red, hard, or damaged. To lessen bruising, do not rub the||
1929|045|H|injection site after a shot. Learn how to store and discard||
1929|046|H|medical supplies safely.||
1929|047|H|   Use this medication regularly to get the most benefit from it.||
1929|048|H|To help you remember, mark your calendar with a reminder.||
1929|049|H|   Tell your doctor if your migraines happen more often or get||
1929|050|H|worse.||
1929|051|B|||
1929|052|S|SIDE EFFECTS:  Redness, pain, or swelling at the injection site||
1929|053|S|may occur. Constipation may also occur. If any of these effects||
1929|054|S|last or get worse, tell your doctor or pharmacist promptly.||
1929|055|S|   Remember that this medication has been prescribed because your||
1929|056|S|doctor has judged that the benefit to you is greater than the||
1929|057|S|risk of side effects. Many people using this medication do not||
1929|058|S|have serious side effects.||
1929|059|S|   Erenumab may raise your blood pressure. Check your blood||
1929|060|S|pressure regularly and tell your doctor if the results are high.||
1929|061|S|Your doctor may control your blood pressure with medication.||
1929|062|S|   Tell your doctor right away if you have any serious side||
1929|063|S|effects, including: blue fingers/toes, cold hands/feet.||
1929|064|S|   A very serious allergic reaction to this drug is rare. If a||
1929|065|S|reaction occurs, it may appear within hours after a dose, or in||
1929|066|S|some cases, more than one week after a dose. Get medical help||
1929|067|S|right away if you notice any symptoms of a serious allergic||
1929|068|S|reaction, including: rash, itching/swelling (especially of the||
1929|069|S|face/tongue/throat), severe dizziness, trouble breathing.||
1929|070|S|   This is not a complete list of possible side effects. If you||
1929|071|S|notice other effects not listed above, contact your doctor or||
1929|072|S|pharmacist.||
1929|073|S|   In the US -||
1929|074|S|   Call your doctor for medical advice about side effects. You||
1929|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1929|076|S|www.fda.gov/medwatch.||
1929|077|S|   In Canada - Call your doctor for medical advice about side||
1929|078|S|effects. You may report side effects to Health Canada at||
1929|079|S|1-866-234-2345.||
1929|080|B|||
1929|081|P|PRECAUTIONS:  Before using erenumab, tell your doctor or||
1929|082|P|pharmacist if you are allergic to it; or if you have any other||
1929|083|P|allergies. This product may contain inactive ingredients (such as||
1929|084|P|dry natural rubber/latex in the needle cover of some brands),||
1929|085|P|which can cause allergic reactions or other problems. Talk to||
1929|086|P|your pharmacist for more details.||
1929|087|P|   Before using this medication, tell your doctor or pharmacist||
1929|088|P|your medical history, especially of: blood circulation problems||
1929|089|P|(such as Raynaud's disease), constipation, high blood pressure.||
1929|090|P|   Before having surgery, tell your doctor or dentist about all||
1929|091|P|the products you use (including prescription drugs,||
1929|092|P|nonprescription drugs, and herbal products).||
1929|093|P|   During pregnancy, this medication should be used only when||
1929|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
1929|095|P|   It is unknown if this medication passes into breast milk.||
1929|096|P|Consult your doctor before breastfeeding.||
1929|097|B|||
1929|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1929|099|I|medications work or increase your risk for serious side effects.||
1929|100|I|This document does not contain all possible drug interactions.||
1929|101|I|Keep a list of all the products you use (including||
1929|102|I|prescription/nonprescription drugs and herbal products) and share||
1929|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
1929|104|I|the dosage of any medicines without your doctor's approval.||
1929|105|B|||
1929|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1929|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1929|108|O|poison control center right away. US residents can call||
1929|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1929|110|B|||
1929|111|N|NOTES:  Do not share this medication with others.||
1929|112|N|   Lab and/or medical tests (such as blood pressure) may be done||
1929|113|N|while you are using this medication. Keep all medical and lab||
1929|114|N|appointments. Consult your doctor for more details.||
1929|115|B|||
1929|116|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1929|117|D|Do not double the dose to catch up. Then use your next dose one||
1929|118|D|month later. Continue to use each dose one month apart. Ask your||
1929|119|D|doctor or pharmacist if you have questions about your schedule.||
1929|120|B|||
1929|121|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1929|122|R|medication in the original packaging to protect from light. This||
1929|123|R|medication may also be stored at room temperature if needed. If||
1929|124|R|the medication is stored at room temperature, do not put it back||
1929|125|R|in the refrigerator and discard after 7 days. Do not leave the||
1929|126|R|syringe/autoinjector in direct sunlight. Keep all medications||
1929|127|R|away from children and pets.||
1929|128|R|   Do not flush medications down the toilet or pour them into a||
1929|129|R|drain unless instructed to do so. Properly discard this product||
1929|130|R|when it is expired or no longer needed. Consult your pharmacist||
1929|131|R|or local waste disposal company.||
1929|132|B|||
1929|133|A|Information last revised March 2025.||
1929|134|A|Copyright(c) 2025 First Databank, Inc.||
1929|135|B|||
1930|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1930|002|Z|does NOT have all possible information about this product. This||
1930|003|Z|information does not assure that this product is safe, effective,||
1930|004|Z|or appropriate for you. This information is not individual||
1930|005|Z|medical advice and does not substitute for the advice of your||
1930|006|Z|health care professional. Always ask your health care||
1930|007|Z|professional for complete information about this product and your||
1930|008|Z|specific health needs.||
1930|009|B|||
1930|010|T|AVATROMBOPAG - ORAL||
1930|011|F|(A-va-TROM-boe-pag)||
1930|012|B|||
1930|013|C|COMMON BRAND NAME(S): Doptelet||
1930|014|B|||
1930|015|U|USES:  This medication is used by people with chronic liver||
1930|016|U|disease and a certain blood disorder (low platelet count) who are||
1930|017|U|scheduled to have a medical or dental procedure. Having a low||
1930|018|U|platelet count increases the risk of too much bleeding during||
1930|019|U|certain procedures. This medication increases the production of||
1930|020|U|platelets by your body to help prevent too much bleeding from the||
1930|021|U|procedure.||
1930|022|U|   Avatrombopag is also used to treat people with a certain blood||
1930|023|U|disorder known as immune thrombocytopenia-ITP. This is a||
1930|024|U|condition where the amount of platelets in the blood is lower||
1930|025|U|than normal. ITP can lead to serious bleeding problems. This||
1930|026|U|medication increases the production of platelets by your body to||
1930|027|U|help prevent too much bleeding from ITP.||
1930|028|B|||
1930|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1930|030|H|from your pharmacist before you start taking avatrombopag and||
1930|031|H|each time you get a refill. If you have any questions, ask your||
1930|032|H|doctor or pharmacist.||
1930|033|H|   If you are taking this medication to prevent bleeding during a||
1930|034|H|medical or dental procedure, take this medication by mouth with||
1930|035|H|food as directed by your doctor, usually once daily for 5 days in||
1930|036|H|a row. Your doctor will tell you how much to take and when to||
1930|037|H|start taking it (usually 10 to 13 days before your procedure).||
1930|038|H|   If you are taking this medication for ITP, take this||
1930|039|H|medication by mouth with food as directed by your doctor, usually||
1930|040|H|once daily.||
1930|041|H|   The dosage is based on your medical condition, lab tests,||
1930|042|H|response to treatment, and other medications you may be taking.||
1930|043|H|Be sure to tell your doctor and pharmacist about all the products||
1930|044|H|you use (including prescription drugs, nonprescription drugs, and||
1930|045|H|herbal products).||
1930|046|H|   Use this medication regularly to get the most benefit from it.||
1930|047|H|To help you remember, take it at the same time each day.||
1930|048|B|||
1930|049|S|SIDE EFFECTS:  Runny nose, swelling of hands/ankles/feet, or||
1930|050|S|fever may occur. If any of these effects last or get worse, tell||
1930|051|S|the doctor or pharmacist promptly.||
1930|052|S|   Remember that this medication has been prescribed because your||
1930|053|S|doctor has judged that the benefit to you is greater than the||
1930|054|S|risk of side effects. Many people using this medication do not||
1930|055|S|have serious side effects.||
1930|056|S|   This medication may rarely cause serious problems from blood||
1930|057|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1930|058|S|legs). You may be at increased risk for blood clots if you have a||
1930|059|S|history of blood clots, chronic liver disease, certain inherited||
1930|060|S|blood clotting disorders, or if you are immobile (such as on very||
1930|061|S|long plane flights or being bedridden). If you use||
1930|062|S|estrogen-containing products, these may also increase your risk.||
1930|063|S|Before using this medication, if you have any of these conditions||
1930|064|S|report them to your doctor or pharmacist (see also Precautions||
1930|065|S|section). Get medical help right away if any of these side||
1930|066|S|effects occur: shortness of breath/rapid breathing,||
1930|067|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1930|068|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1930|069|S|sudden/severe headaches, trouble speaking, weakness on one side||
1930|070|S|of the body, sudden vision changes, stomach/abdominal pain or||
1930|071|S|tenderness.||
1930|072|S|   A very serious allergic reaction to this drug is rare.||
1930|073|S|However, get medical help right away if you notice any symptoms||
1930|074|S|of a serious allergic reaction, including: rash, itching/swelling||
1930|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1930|076|S|breathing.||
1930|077|S|   This is not a complete list of possible side effects. If you||
1930|078|S|notice other effects not listed above, contact your doctor or||
1930|079|S|pharmacist.||
1930|080|S|   In the US -||
1930|081|S|   Call your doctor for medical advice about side effects. You||
1930|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1930|083|S|www.fda.gov/medwatch.||
1930|084|S|   In Canada - Call your doctor for medical advice about side||
1930|085|S|effects. You may report side effects to Health Canada at||
1930|086|S|1-866-234-2345.||
1930|087|B|||
1930|088|P|PRECAUTIONS:  Before taking avatrombopag, tell your doctor or||
1930|089|P|pharmacist if you are allergic to it; or if you have any other||
1930|090|P|allergies. This product may contain inactive ingredients, which||
1930|091|P|can cause allergic reactions or other problems. Talk to your||
1930|092|P|pharmacist for more details.||
1930|093|P|   Before using this medication, tell your doctor or pharmacist||
1930|094|P|your medical history, especially of: blood clotting disorders||
1930|095|P|(such as protein C or protein S deficiency, antithrombin||
1930|096|P|deficiency, Factor V Leiden).||
1930|097|P|   Before having surgery, tell your doctor or dentist about all||
1930|098|P|the products you use (including prescription drugs,||
1930|099|P|nonprescription drugs, and herbal products).||
1930|100|P|   During pregnancy, this medication should be used only when||
1930|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
1930|102|P|   It is unknown if this medication passes into breast milk.||
1930|103|P|Because of the possible risk to the infant, breastfeeding is not||
1930|104|P|recommended while using this medication and for at least 2 weeks||
1930|105|P|after the last dose. Consult your doctor before breastfeeding.||
1930|106|B|||
1930|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1930|108|I|medications work or increase your risk for serious side effects.||
1930|109|I|This document does not contain all possible drug interactions.||
1930|110|I|Keep a list of all the products you use (including||
1930|111|I|prescription/nonprescription drugs and herbal products) and share||
1930|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
1930|113|I|the dosage of any medicines without your doctor's approval.||
1930|114|B|||
1930|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1930|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1930|117|O|poison control center right away. US residents can call||
1930|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1930|119|B|||
1930|120|N|NOTES:  Do not share this medication with others.||
1930|121|N|   Lab and/or medical tests (such as platelet count or blood||
1930|122|N|mineral levels) should be done before you start taking this||
1930|123|N|medication and while you are taking it. Keep all medical and lab||
1930|124|N|appointments.||
1930|125|B|||
1930|126|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1930|127|D|remember. If it is near the time of the next dose, skip the||
1930|128|D|missed dose. Take your next dose at the regular time. Do not||
1930|129|D|double the dose to catch up.||
1930|130|B|||
1930|131|R|STORAGE:  Store in the original package at room temperature away||
1930|132|R|from light and moisture. Do not store in the bathroom. Keep all||
1930|133|R|medications away from children and pets.||
1930|134|R|   Do not flush medications down the toilet or pour them into a||
1930|135|R|drain unless instructed to do so. Properly discard this product||
1930|136|R|when it is expired or no longer needed. Consult your pharmacist||
1930|137|R|or local waste disposal company.||
1930|138|B|||
1930|139|M|MEDICAL ALERT:  Your condition can cause complications in a||
1930|140|M|medical emergency. For information about enrolling in MedicAlert,||
1930|141|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1930|142|B|||
1930|143|A|Information last revised October 2025.||
1930|144|A|Copyright(c) 2025 First Databank, Inc.||
1930|145|B|||
1931|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1931|002|Z|does NOT have all possible information about this product. This||
1931|003|Z|information does not assure that this product is safe, effective,||
1931|004|Z|or appropriate for you. This information is not individual||
1931|005|Z|medical advice and does not substitute for the advice of your||
1931|006|Z|health care professional. Always ask your health care||
1931|007|Z|professional for complete information about this product and your||
1931|008|Z|specific health needs.||
1931|009|B|||
1931|010|T|PEGVALIASE - SUBCUTANEOUS INJECTION||
1931|011|F|(peg-VAL-i-ase)||
1931|012|B|||
1931|013|C|COMMON BRAND NAME(S): Palynziq||
1931|014|B|||
1931|015|W|WARNING:  This medication has caused serious allergic reactions||
1931|016|W|which can be life-threatening. This reaction can happen at any||
1931|017|W|time during treatment. Get medical help right away if you notice||
1931|018|W|any symptoms of a serious allergic reaction, including:||
1931|019|W|flushing/rash, itching/swelling (especially of the face, tongue,||
1931|020|W|throat), severe dizziness, trouble breathing, fast heartbeat,||
1931|021|W|fainting, chest discomfort/tightness, nausea, vomiting, or||
1931|022|W|diarrhea. To be sure that you do not have a serious reaction, you||
1931|023|W|will need to stay in a health care setting (such as a doctor's||
1931|024|W|office) for at least 1 hour after using this drug for the first||
1931|025|W|time so your doctor can carefully monitor you and provide medical||
1931|026|W|help if needed.||
1931|027|W|   After the first injection, you and your doctor may decide you||
1931|028|W|can use this medication at home. Your health care provider will||
1931|029|W|instruct you and/or your caregiver how to inject this medication||
1931|030|W|the right way.||
1931|031|W|   Your doctor will also prescribe another medication||
1931|032|W|(epinephrine) in case you have a serious allergic reaction||
1931|033|W|outside the health care setting. Read the Patient Information||
1931|034|W|Leaflet for this medication provided by your pharmacist. Learn||
1931|035|W|ahead of time when and how to use your brand of epinephrine. If||
1931|036|W|you have to use it, get medical help as soon as you have used it.||
1931|037|W|   To receive pegvaliase in the United States, you must||
1931|038|W|understand, agree to, and carefully follow the requirements of||
1931|039|W|the REMS Program for this medication. If you live in Canada or||
1931|040|W|any other country, consult your doctor and pharmacist for your||
1931|041|W|country's regulations.||
1931|042|B|||
1931|043|U|USES:  This medication is used by people with a certain inherited||
1931|044|U|condition (phenylketonuria) to reduce high levels of a certain||
1931|045|U|substance (phenylalanine) that builds up in the blood. Having||
1931|046|U|high levels of phenylalanine in the blood may cause brain damage,||
1931|047|U|heart problems, an abnormally small head size, and behavioral||
1931|048|U|problems. Pegvaliase works by breaking down phenylalanine in the||
1931|049|U|blood.||
1931|050|U|   Along with using this medication, you should follow a special||
1931|051|U|diet to control your blood phenylalanine levels. Ask your doctor||
1931|052|U|for details.||
1931|053|B|||
1931|054|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1931|055|H|provided by your pharmacist before you start using pegvaliase and||
1931|056|H|each time you get a refill. Ask your health care professional how||
1931|057|H|to prepare and use this medication. If you have any questions,||
1931|058|H|ask your doctor or pharmacist. Carry the Patient Wallet Card with||
1931|059|H|you at all times. Show the card to all of your health care||
1931|060|H|providers to let them know that you are being treated with||
1931|061|H|pegvaliase.||
1931|062|H|   Inject this medication under the skin as directed by your||
1931|063|H|doctor, usually starting with once weekly for 4 weeks, then||
1931|064|H|gradually increasing over 5 weeks to once daily. The injection is||
1931|065|H|given in the thigh, abdomen, top of the buttocks, or upper arm.||
1931|066|H|The dosage is based on your medical condition and response to||
1931|067|H|treatment. Your doctor may prescribe other medications (such as||
1931|068|H|antihistamines, acetaminophen) before each dose to help prevent||
1931|069|H|side effects. Carefully follow your doctor's directions.||
1931|070|H|   Take the medication out of the refrigerator at least 30||
1931|071|H|minutes before you inject it to allow it to reach room||
1931|072|H|temperature. Do not warm up this medication any other way (for||
1931|073|H|example, do not heat it in the microwave or place it in hot||
1931|074|H|water). Do not shake the medication. Before using, check this||
1931|075|H|product for particles or discoloration. If either is present, do||
1931|076|H|not use the liquid. Before injecting each dose, clean the skin||
1931|077|H|you are going to inject into (the injection site) with rubbing||
1931|078|H|alcohol. Change the injection site each time to lessen injury||
1931|079|H|under the skin. Do not inject into skin that is injured, tender,||
1931|080|H|hard, red, bruised, or tattooed, or into moles, scars, birthmarks||
1931|081|H|or rashes. To lessen bruising, do not rub the injection site||
1931|082|H|after a shot. Learn how to store and discard medical supplies||
1931|083|H|safely.||
1931|084|H|   Use this medication regularly to get the most benefit from it.||
1931|085|H|To help you remember, mark your calendar with a reminder.||
1931|086|B|||
1931|087|S|SIDE EFFECTS:  See also Warning section.||
1931|088|S|   Redness, itching, pain, or bruising at the injection site may||
1931|089|S|occur. Muscle/joint/back/neck pain, headache,||
1931|090|S|mouth/throat/abdominal pain, dizziness, cough, or tiredness may||
1931|091|S|also occur. If any of these effects last or get worse, tell your||
1931|092|S|doctor or pharmacist promptly.||
1931|093|S|   Temporary hair loss may occur. Normal hair growth should||
1931|094|S|return if treatment is ended.||
1931|095|S|   Remember that this medication has been prescribed because your||
1931|096|S|doctor has judged that the benefit to you is greater than the||
1931|097|S|risk of side effects. Many people using this medication do not||
1931|098|S|have serious side effects.||
1931|099|S|   Tell your doctor right away if you have any serious side||
1931|100|S|effects, including: fluid or pus at the injection site.||
1931|101|S|   Pegvaliase can commonly cause a rash that is usually not||
1931|102|S|serious. However, you may not be able to tell it apart from a||
1931|103|S|rare rash that could be a sign of a severe reaction. Get medical||
1931|104|S|help right away if you develop any rash.||
1931|105|S|   This is not a complete list of possible side effects. If you||
1931|106|S|notice other effects not listed above, contact your doctor or||
1931|107|S|pharmacist.||
1931|108|S|   In the US -||
1931|109|S|   Call your doctor for medical advice about side effects. You||
1931|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1931|111|S|www.fda.gov/medwatch.||
1931|112|S|   In Canada - Call your doctor for medical advice about side||
1931|113|S|effects. You may report side effects to Health Canada at||
1931|114|S|1-866-234-2345.||
1931|115|B|||
1931|116|P|PRECAUTIONS:  Before using pegvaliase, tell your doctor or||
1931|117|P|pharmacist if you are allergic to it; or if you have any other||
1931|118|P|allergies. This product may contain inactive ingredients which||
1931|119|P|can cause allergic reactions or other problems. Talk to your||
1931|120|P|pharmacist for more details.||
1931|121|P|   Before using this medication, tell your doctor or pharmacist||
1931|122|P|your medical history.||
1931|123|P|   Before having surgery, tell your doctor or dentist about all||
1931|124|P|the products you use (including prescription drugs,||
1931|125|P|nonprescription drugs, and herbal products).||
1931|126|P|   During pregnancy, this medication should be used only when||
1931|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
1931|128|P|   It is unknown if this medication passes into breast milk.||
1931|129|P|Consult your doctor before breastfeeding.||
1931|130|B|||
1931|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1931|132|I|medications work or increase your risk for serious side effects.||
1931|133|I|This document does not contain all possible drug interactions.||
1931|134|I|Keep a list of all the products you use (including||
1931|135|I|prescription/nonprescription drugs and herbal products) and share||
1931|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
1931|137|I|the dosage of any medicines without your doctor's approval.||
1931|138|B|||
1931|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1931|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1931|141|O|poison control center right away. US residents can call||
1931|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1931|143|B|||
1931|144|N|NOTES:  Do not share this medication with others.||
1931|145|N|   Lab and/or medical tests (such as phenylalanine levels) must||
1931|146|N|be done before you start using this medication and while you are||
1931|147|N|using it. Keep all medical and lab appointments.||
1931|148|B|||
1931|149|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
1931|150|D|next dose at the regular time. Do not double the dose to catch||
1931|151|D|up.||
1931|152|B|||
1931|153|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1931|154|R|medication in the original package to protect from light. This||
1931|155|R|medication may also be stored at room temperature if needed. If||
1931|156|R|the medication is stored at room temperature, do not put it back||
1931|157|R|in the refrigerator and discard after 30 days. Keep all||
1931|158|R|medications away from children and pets.||
1931|159|R|   Do not flush medications down the toilet or pour them into a||
1931|160|R|drain unless instructed to do so. Properly discard this product||
1931|161|R|when it is expired or no longer needed. Consult your pharmacist||
1931|162|R|or local waste disposal company.||
1931|163|B|||
1931|164|A|Information last revised November 2025.||
1931|165|A|Copyright(c) 2025 First Databank, Inc.||
1931|166|B|||
1932|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1932|002|Z|does NOT have all possible information about this product. This||
1932|003|Z|information does not assure that this product is safe, effective,||
1932|004|Z|or appropriate for you. This information is not individual||
1932|005|Z|medical advice and does not substitute for the advice of your||
1932|006|Z|health care professional. Always ask your health care||
1932|007|Z|professional for complete information about this product and your||
1932|008|Z|specific health needs.||
1932|009|B|||
1932|010|T|ABIRATERONE (SUBMICRONIZED) - ORAL||
1932|011|F|(A-bir-A-ter-one)||
1932|012|B|||
1932|013|C|COMMON BRAND NAME(S): Yonsa||
1932|014|B|||
1932|015|U|USES:  This medication is used to treat men with prostate cancer.||
1932|016|U|Abiraterone belongs to a class of drugs known as anti-androgens||
1932|017|U|(anti-testosterone). Testosterone, a natural hormone, helps||
1932|018|U|prostate cancer to grow and spread. Abiraterone works by blocking||
1932|019|U|the production of testosterone, which helps slow down the growth||
1932|020|U|and spread of prostate cancer.||
1932|021|U|   This medication should not be used by women or children.||
1932|022|B|||
1932|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1932|024|H|from your pharmacist before you start taking abiraterone and each||
1932|025|H|time you get a refill. If you have any questions, ask your doctor||
1932|026|H|or pharmacist.||
1932|027|H|   Different brands of this medication may have different dosing||
1932|028|H|directions. Do not change brands of this medication without your||
1932|029|H|doctor's direction.||
1932|030|H|   Take this medication by mouth with or without food as directed||
1932|031|H|by your doctor, usually once daily. Swallow this medication whole||
1932|032|H|with water. Do not crush or chew the tablets.||
1932|033|H|   The dosage is based on your medical condition, lab results,||
1932|034|H|response to treatment, and other medications you may be taking.||
1932|035|H|Be sure to tell your doctor and pharmacist about all the products||
1932|036|H|you use (including prescription drugs, nonprescription drugs, and||
1932|037|H|herbal products).||
1932|038|H|   Use this medication regularly to get the most benefit from it.||
1932|039|H|To help you remember, take it at the same time each day.||
1932|040|H|   Do not increase your dose or use this drug more often or for||
1932|041|H|longer than prescribed. Your condition will not improve any||
1932|042|H|faster, and your risk of serious side effects will increase.||
1932|043|H|   Tell your doctor if your condition gets worse (such as||
1932|044|H|urination becomes more difficult, bone pain increases).||
1932|045|H|   Since this drug can be absorbed through the skin and lungs and||
1932|046|H|may harm an unborn baby, women who are pregnant or who may become||
1932|047|H|pregnant should not handle this medication or breathe the dust||
1932|048|H|from the tablets.||
1932|049|B|||
1932|050|S|SIDE EFFECTS:  Headache, hot flushes, joint pain, heartburn, or||
1932|051|S|cold-like symptoms may occur. If any of these effects last or get||
1932|052|S|worse, tell your doctor or pharmacist promptly.||
1932|053|S|   Remember that this medication has been prescribed because your||
1932|054|S|doctor has judged that the benefit to you is greater than the||
1932|055|S|risk of side effects. Many people using this medication do not||
1932|056|S|have serious side effects.||
1932|057|S|   This medication may raise your blood pressure. Check your||
1932|058|S|blood pressure regularly and tell your doctor if the results are||
1932|059|S|high. Your doctor may control your blood pressure with||
1932|060|S|medication.||
1932|061|S|   Tell your doctor right away if you have any serious side||
1932|062|S|effects, including: increased urination, painful urination,||
1932|063|S|fast/irregular heartbeat, muscle cramps/weakness, leg pain,||
1932|064|S|swelling in legs/feet.||
1932|065|S|   Get medical help right away if you have any very serious side||
1932|066|S|effects, including: chest pain, fast/irregular heartbeat, severe||
1932|067|S|dizziness, fainting, symptoms of liver disease (such as||
1932|068|S|nausea/vomiting that doesn't stop, loss of appetite,||
1932|069|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1932|070|S|   A very serious allergic reaction to this drug is rare.||
1932|071|S|However, get medical help right away if you notice any symptoms||
1932|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1932|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1932|074|S|breathing.||
1932|075|S|   This is not a complete list of possible side effects. If you||
1932|076|S|notice other effects not listed above, contact your doctor or||
1932|077|S|pharmacist.||
1932|078|S|   In the US -||
1932|079|S|   Call your doctor for medical advice about side effects. You||
1932|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1932|081|S|www.fda.gov/medwatch.||
1932|082|S|   In Canada - Call your doctor for medical advice about side||
1932|083|S|effects. You may report side effects to Health Canada at||
1932|084|S|1-866-234-2345.||
1932|085|B|||
1932|086|P|PRECAUTIONS:  Before taking abiraterone, tell your doctor or||
1932|087|P|pharmacist if you are allergic to it; or if you have any other||
1932|088|P|allergies. This product may contain inactive ingredients, which||
1932|089|P|can cause allergic reactions or other problems. Talk to your||
1932|090|P|pharmacist for more details.||
1932|091|P|   Before using this medication, tell your doctor or pharmacist||
1932|092|P|your medical history, especially of: previous heart attack, high||
1932|093|P|blood pressure, liver problems, diabetes.||
1932|094|P|   Abiraterone may cause a condition that affects the heart||
1932|095|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1932|096|P|serious (rarely fatal) fast/irregular heartbeat and other||
1932|097|P|symptoms (such as severe dizziness, fainting) that need medical||
1932|098|P|attention right away.||
1932|099|P|   The risk of QT prolongation may be increased if you have||
1932|100|P|certain medical conditions or are taking other drugs that may||
1932|101|P|cause QT prolongation. Before using abiraterone, tell your doctor||
1932|102|P|or pharmacist of all the drugs you take and if you have any of||
1932|103|P|the following conditions: certain heart problems (heart failure,||
1932|104|P|slow heartbeat, QT prolongation in the EKG), family history of||
1932|105|P|certain heart problems (QT prolongation in the EKG, sudden||
1932|106|P|cardiac death).||
1932|107|P|   Low levels of potassium or magnesium in the blood may also||
1932|108|P|increase your risk of QT prolongation. This risk may increase if||
1932|109|P|you use certain drugs (such as diuretics/"water pills") or if you||
1932|110|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1932|111|P|Talk to your doctor about using abiraterone safely.||
1932|112|P|   Using corticosteroid medications for a long time along with||
1932|113|P|abiraterone can make it more difficult for your body to respond||
1932|114|P|to physical stress. Before having surgery or emergency treatment,||
1932|115|P|or if you get a serious illness/injury, tell your doctor or||
1932|116|P|dentist that you are using this medication or have used this||
1932|117|P|medication within the past 12 months. Tell your doctor right away||
1932|118|P|if you develop unusual/extreme tiredness or weight loss. If you||
1932|119|P|will be using this medication for a long time, carry a warning||
1932|120|P|card or medical ID bracelet that identifies your use of this||
1932|121|P|medication.||
1932|122|P|   Before having surgery, tell your doctor or dentist about all||
1932|123|P|the products you use (including prescription drugs,||
1932|124|P|nonprescription drugs, and herbal products).||
1932|125|P|   Older adults may be more sensitive to the side effects of this||
1932|126|P|drug, especially QT prolongation (see above).||
1932|127|P|   This medication should not be used by women, especially during||
1932|128|P|pregnancy or breastfeeding. It may harm an unborn or||
1932|129|P|breastfeeding baby. Men with female partners of childbearing age||
1932|130|P|should use reliable form(s) of birth control while taking this||
1932|131|P|medication and for at least 3 weeks after stopping treatment.||
1932|132|P|Consult your doctor for more details.||
1932|133|B|||
1932|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1932|135|I|medications work or increase your risk for serious side effects.||
1932|136|I|This document does not contain all possible drug interactions.||
1932|137|I|Keep a list of all the products you use (including||
1932|138|I|prescription/nonprescription drugs and herbal products) and share||
1932|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
1932|140|I|the dosage of any medicines without your doctor's approval.||
1932|141|I|   A product that may interact with this drug is: radium Ra 223.||
1932|142|I|   Other medications can affect the removal of abiraterone from||
1932|143|I|your body, which may affect how abiraterone works. Examples||
1932|144|I|include drugs used to treat seizures (such as carbamazepine,||
1932|145|I|phenytoin, phenobarbital, primidone), St. John's wort, among||
1932|146|I|others.||
1932|147|B|||
1932|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1932|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1932|150|O|poison control center right away. US residents can call||
1932|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1932|152|B|||
1932|153|N|NOTES:  Do not share this medication with others.||
1932|154|N|   Lab and/or medical tests (such as blood pressure, potassium||
1932|155|N|levels, liver function, blood PSA) should be done before you||
1932|156|N|start taking this medication and while you are taking it. Keep||
1932|157|N|all medical and lab appointments.||
1932|158|B|||
1932|159|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1932|160|D|next dose at the regular time. Do not double the dose to catch||
1932|161|D|up. If you miss more than one dose, talk to your doctor right||
1932|162|D|away.||
1932|163|B|||
1932|164|R|STORAGE:  Store at room temperature away from light and moisture.||
1932|165|R|Do not store in the bathroom. Keep all medications away from||
1932|166|R|children and pets.||
1932|167|R|   Do not flush medications down the toilet or pour them into a||
1932|168|R|drain unless instructed to do so. Properly discard this product||
1932|169|R|when it is expired or no longer needed. Consult your pharmacist||
1932|170|R|or local waste disposal company.||
1932|171|B|||
1932|172|M|MEDICAL ALERT:  Your condition can cause complications in a||
1932|173|M|medical emergency. For information about enrolling in MedicAlert,||
1932|174|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1932|175|B|||
1932|176|A|Information last revised May 2024.||
1932|177|A|Copyright(c) 2025 First Databank, Inc.||
1932|178|B|||
1934|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1934|002|Z|does NOT have all possible information about this product. This||
1934|003|Z|information does not assure that this product is safe, effective,||
1934|004|Z|or appropriate for you. This information is not individual||
1934|005|Z|medical advice and does not substitute for the advice of your||
1934|006|Z|health care professional. Always ask your health care||
1934|007|Z|professional for complete information about this product and your||
1934|008|Z|specific health needs.||
1934|009|B|||
1934|010|T|BARICITINIB - ORAL||
1934|011|F|(BAR-i-SYE-ti-nib)||
1934|012|B|||
1934|013|C|COMMON BRAND NAME(S): Olumiant||
1934|014|B|||
1934|015|W|WARNING:  Baricitinib may lower your ability to fight infections.||
1934|016|W|This may make you more likely to get a serious (rarely fatal)||
1934|017|W|infection or make any infection you have worse. The most common||
1934|018|W|serious infections include pneumonia, shingles, and urinary tract||
1934|019|W|infections. The risk for infections may be higher if you also||
1934|020|W|take other drugs that suppress the immune system (such as||
1934|021|W|methotrexate, corticosteroids). Tell your doctor right away if||
1934|022|W|you have any signs of infection (such as a sore throat that||
1934|023|W|doesn't go away, fever, chills, cough, painful/frequent||
1934|024|W|urination, non-healing skin sores).||
1934|025|W|   If treating rheumatoid arthritis or alopecia areata, you||
1934|026|W|should have a tuberculosis (TB) skin test before and during||
1934|027|W|treatment with this medication. Tell your doctor if you have been||
1934|028|W|near someone with tuberculosis or have lived or traveled in areas||
1934|029|W|where certain fungal infections (such as coccidioidomycosis,||
1934|030|W|histoplasmosis) are common. These areas include the Ohio and||
1934|031|W|Mississippi River valleys and the southwestern United States.||
1934|032|W|   Though it is very unlikely to occur, there may be a risk of||
1934|033|W|developing cancer (such as lymphoma, skin cancer, lung cancer)||
1934|034|W|with this medication. Your risk may be higher if you are a||
1934|035|W|current or past smoker. Tell your doctor right away if you||
1934|036|W|develop symptoms such as fever or cough that doesn't go away,||
1934|037|W|wheezing, unusual lumps/growths, unexplained weight loss, night||
1934|038|W|sweats, change in appearance or size of moles, or unusual skin||
1934|039|W|changes.||
1934|040|W|   Baricitinib may rarely cause serious (possibly fatal) problems||
1934|041|W|from blood clots (such as heart attack, stroke, blood clots in||
1934|042|W|the lungs or legs). You may be at an increased risk for blood||
1934|043|W|clots if you are a current or past smoker, or are 50 years of age||
1934|044|W|or older and have at least one risk factor for heart disease.||
1934|045|W|Discuss the risks and benefits of treatment with your doctor. Get||
1934|046|W|medical help right away if any of these side effects occur:||
1934|047|W|shortness of breath/rapid breathing, chest/jaw/left arm pain,||
1934|048|W|unusual sweating, confusion, sudden dizziness/fainting,||
1934|049|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1934|050|W|trouble speaking, weakness on one side of the body, or sudden||
1934|051|W|vision changes.||
1934|052|B|||
1934|053|U|USES:  Baricitinib is used to treat rheumatoid arthritis. It||
1934|054|U|helps decrease pain, tenderness, and swelling in the joints. It||
1934|055|U|is also used to treat a certain immune disorder which causes hair||
1934|056|U|loss (alopecia areata).||
1934|057|U|   In the US, baricitinib is also being used to treat coronavirus||
1934|058|U|disease (COVID-19). It is used in certain patients in the||
1934|059|U|hospital who need supplemental oxygen (including patients on a||
1934|060|U|mechanical ventilator).||
1934|061|B|||
1934|062|H|HOW TO USE:  Read the Medication Guide provided by your||
1934|063|H|pharmacist before you start taking baricitinib and each time you||
1934|064|H|get a refill. If you have any questions, ask your doctor or||
1934|065|H|pharmacist.||
1934|066|H|   Take this medication by mouth with or without food as directed||
1934|067|H|by your doctor, usually once daily.||
1934|068|H|   If you have trouble swallowing this medication whole, you may||
1934|069|H|place your dose in a cup with about 2 teaspoonful (10||
1934|070|H|milliliters) of room temperature water to dissolve the tablet(s).||
1934|071|H|Stir the mixture gently and then drink all of it right away.||
1934|072|H|Rinse the cup with another 2 teaspoonful (10 milliliters) of||
1934|073|H|water and drink the rinse water to make sure you get all of your||
1934|074|H|dose.||
1934|075|H|   The dosage is based on your medical condition, response to||
1934|076|H|treatment, and other medications you may be taking. Be sure to||
1934|077|H|tell your doctor and pharmacist about all the products you use||
1934|078|H|(including prescription drugs, nonprescription drugs, and herbal||
1934|079|H|products).||
1934|080|H|   Use this medication regularly to get the most benefit from it.||
1934|081|H|To help you remember, take it at the same time each day.||
1934|082|H|   Do not increase your dose or use this drug more often or for||
1934|083|H|longer than prescribed. Your condition will not improve any||
1934|084|H|faster, and your risk of side effects will increase.||
1934|085|H|   Tell your doctor if your condition does not get better or if||
1934|086|H|it gets worse.||
1934|087|B|||
1934|088|S|SIDE EFFECTS:  See also Warning section.||
1934|089|S|   People using this medication may have serious side effects.||
1934|090|S|However, you have been prescribed this drug because your doctor||
1934|091|S|has judged that the benefit to you is greater than the risk of||
1934|092|S|side effects. Careful monitoring by your doctor may decrease your||
1934|093|S|risk.||
1934|094|S|   Tell your doctor right away if you have any serious side||
1934|095|S|effects, including: signs of anemia (such as unusual tiredness,||
1934|096|S|pale skin, fast heartbeat), signs of liver disease (such as||
1934|097|S|nausea/vomiting that doesn't stop, loss of appetite,||
1934|098|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
1934|099|S|of a serious tear in the stomach or intestinal wall (such as||
1934|100|S|severe stomach/abdominal pain that doesn't go away, fever, severe||
1934|101|S|dizziness, fainting, severe nausea/vomiting).||
1934|102|S|   A very serious allergic reaction to this drug is rare.||
1934|103|S|However, get medical help right away if you notice any symptoms||
1934|104|S|of a serious allergic reaction, including: rash, itching/swelling||
1934|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1934|106|S|breathing.||
1934|107|S|   This is not a complete list of possible side effects. If you||
1934|108|S|notice other effects not listed above, contact your doctor or||
1934|109|S|pharmacist.||
1934|110|S|   In the US -||
1934|111|S|   Call your doctor for medical advice about side effects. You||
1934|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1934|113|S|www.fda.gov/medwatch.||
1934|114|S|   In Canada - Call your doctor for medical advice about side||
1934|115|S|effects. You may report side effects to Health Canada at||
1934|116|S|1-866-234-2345.||
1934|117|B|||
1934|118|P|PRECAUTIONS:  See also Warning section.||
1934|119|P|   Before taking baricitinib, tell your doctor or pharmacist if||
1934|120|P|you are allergic to it; or if you have any other allergies. This||
1934|121|P|product may contain inactive ingredients, which can cause||
1934|122|P|allergic reactions or other problems. Talk to your pharmacist for||
1934|123|P|more details.||
1934|124|P|   Before using this medication, tell your doctor or pharmacist||
1934|125|P|your medical history, especially of: blood clots (such as in the||
1934|126|P|lungs, legs), heart problems (such as previous heart attack),||
1934|127|P|stroke, current or past smoking, blood/bone marrow problems (such||
1934|128|P|as anemia), cancer, kidney disease, liver disease (such as||
1934|129|P|hepatitis B or C), past/recent/current infections (such as||
1934|130|P|tuberculosis, herpes zoster, HIV infection), stomach/intestinal||
1934|131|P|problems (such as ulcers, diverticulitis).||
1934|132|P|   Baricitinib can make you more likely to get infections or may||
1934|133|P|make current infections worse. Stay away from anyone who has an||
1934|134|P|infection that may easily spread (such as chickenpox, COVID-19,||
1934|135|P|measles, flu). Talk to your doctor if you have been exposed to an||
1934|136|P|infection or for more details.||
1934|137|P|   Tell your health care professional that you are using||
1934|138|P|baricitinib before having any immunizations/vaccinations. Avoid||
1934|139|P|contact with people who have recently received live vaccines||
1934|140|P|(such as flu vaccine inhaled through the nose).||
1934|141|P|   Before having surgery, tell your doctor or dentist about all||
1934|142|P|the products you use (including prescription drugs,||
1934|143|P|nonprescription drugs, and herbal products).||
1934|144|P|   During pregnancy, this medication should be used only when||
1934|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
1934|146|P|   It is unknown if this medication passes into breast milk.||
1934|147|P|Because of the possible risk to the infant, breastfeeding is not||
1934|148|P|recommended while taking this medication and for at least 4 days||
1934|149|P|after the last dose. Consult your doctor before breastfeeding.||
1934|150|B|||
1934|151|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1934|152|I|medications work or increase your risk for serious side effects.||
1934|153|I|This document does not contain all possible drug interactions.||
1934|154|I|Keep a list of all the products you use (including||
1934|155|I|prescription/nonprescription drugs and herbal products) and share||
1934|156|I|it with your doctor and pharmacist. Do not start, stop, or change||
1934|157|I|the dosage of any medicines without your doctor's approval.||
1934|158|B|||
1934|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1934|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1934|161|O|poison control center right away. US residents can call||
1934|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1934|163|B|||
1934|164|N|NOTES:  Do not share this medication with others.||
1934|165|N|   Lab and/or medical tests (such as liver/kidney function,||
1934|166|N|complete blood count, cholesterol levels, skin exams) should be||
1934|167|N|done while you are taking this medication. Keep all medical and||
1934|168|N|lab appointments.||
1934|169|B|||
1934|170|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1934|171|D|remember. If it is near the time of the next dose, skip the||
1934|172|D|missed dose. Take your next dose at the regular time. Do not||
1934|173|D|double the dose to catch up.||
1934|174|B|||
1934|175|R|STORAGE:  Store at room temperature away from light and moisture.||
1934|176|R|Do not store in the bathroom. Keep all medications away from||
1934|177|R|children and pets.||
1934|178|R|   Do not flush medications down the toilet or pour them into a||
1934|179|R|drain unless instructed to do so. Properly discard this product||
1934|180|R|when it is expired or no longer needed. Consult your pharmacist||
1934|181|R|or local waste disposal company.||
1934|182|B|||
1934|183|M|MEDICAL ALERT:  Your condition can cause complications in a||
1934|184|M|medical emergency. For information about enrolling in MedicAlert,||
1934|185|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1934|186|B|||
1934|187|A|Information last revised August 2024.||
1934|188|A|Copyright(c) 2025 First Databank, Inc.||
1934|189|B|||
1935|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1935|002|Z|does NOT have all possible information about this product. This||
1935|003|Z|information does not assure that this product is safe, effective,||
1935|004|Z|or appropriate for you. This information is not individual||
1935|005|Z|medical advice and does not substitute for the advice of your||
1935|006|Z|health care professional. Always ask your health care||
1935|007|Z|professional for complete information about this product and your||
1935|008|Z|specific health needs.||
1935|009|B|||
1935|010|T|LOFEXIDINE - ORAL||
1935|011|F|(loe-FEX-i-deen)||
1935|012|B|||
1935|013|C|COMMON BRAND NAME(S): Lucemyra||
1935|014|B|||
1935|015|U|USES:  Lofexidine is used to decrease withdrawal symptoms caused||
1935|016|U|by stopping opioids.||
1935|017|U|   It can be used as part of a complete treatment program for||
1935|018|U|drug abuse (such as compliance monitoring, counseling, behavioral||
1935|019|U|contract, lifestyle changes).||
1935|020|B|||
1935|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1935|022|H|from your pharmacist before you start taking lofexidine and each||
1935|023|H|time you get a refill. If you have any questions, ask your doctor||
1935|024|H|or pharmacist.||
1935|025|H|   Take this medication by mouth with or without food as directed||
1935|026|H|by your doctor, usually 4 times daily (at least 5 to 6 hours||
1935|027|H|between doses).||
1935|028|H|   The dosage is based on your medical condition and response to||
1935|029|H|treatment. Your doctor will adjust the dose based on withdrawal||
1935|030|H|symptoms. Do not increase your dose or use this drug more often||
1935|031|H|or for longer than prescribed. Your condition will not improve||
1935|032|H|any faster, and your risk of side effects will increase.||
1935|033|H|   Use this medication regularly to get the most benefit from it.||
1935|034|H|To help you remember, use it at the same times each day.||
1935|035|H|   If you suddenly stop using this medication, you may have high||
1935|036|H|blood pressure or withdrawal symptoms (such as diarrhea, trouble||
1935|037|H|sleeping, anxiety, chills, sweating, muscle aches). To help||
1935|038|H|prevent withdrawal, your doctor may lower your dose slowly. Tell||
1935|039|H|your doctor or pharmacist right away if you have withdrawal.||
1935|040|B|||
1935|041|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, slow||
1935|042|S|heartbeat, or dry mouth may occur. If any of these effects last||
1935|043|S|or get worse, tell your doctor or pharmacist promptly.||
1935|044|S|   To reduce the risk of dizziness and lightheadedness, get up||
1935|045|S|slowly when rising from a sitting or lying position.||
1935|046|S|   Remember that this medication has been prescribed because your||
1935|047|S|doctor has judged that the benefit to you is greater than the||
1935|048|S|risk of side effects. Many people using this medication do not||
1935|049|S|have serious side effects.||
1935|050|S|   Tell your doctor right away if you have any serious side||
1935|051|S|effects, including: ringing in the ears.||
1935|052|S|   Get medical help right away if you have any very serious side||
1935|053|S|effects, including: fainting, fast/irregular heartbeat, severe||
1935|054|S|dizziness.||
1935|055|S|   A very serious allergic reaction to this drug is rare.||
1935|056|S|However, get medical help right away if you notice any symptoms||
1935|057|S|of a serious allergic reaction, including: rash, itching/swelling||
1935|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1935|059|S|breathing.||
1935|060|S|   This is not a complete list of possible side effects. If you||
1935|061|S|notice other effects not listed above, contact your doctor or||
1935|062|S|pharmacist.||
1935|063|S|   In the US -||
1935|064|S|   Call your doctor for medical advice about side effects. You||
1935|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1935|066|S|www.fda.gov/medwatch.||
1935|067|S|   In Canada - Call your doctor for medical advice about side||
1935|068|S|effects. You may report side effects to Health Canada at||
1935|069|S|1-866-234-2345.||
1935|070|B|||
1935|071|P|PRECAUTIONS:  Before taking lofexidine, tell your doctor or||
1935|072|P|pharmacist if you are allergic to it; or if you have any other||
1935|073|P|allergies. This product may contain inactive ingredients, which||
1935|074|P|can cause allergic reactions or other problems. Talk to your||
1935|075|P|pharmacist for more details.||
1935|076|P|   Before using this medication, tell your doctor or pharmacist||
1935|077|P|your medical history, especially of: liver disease, kidney||
1935|078|P|disease, high or low blood pressure, heart disease (such as||
1935|079|P|coronary artery disease), stroke.||
1935|080|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1935|081|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1935|082|P|machinery, or do anything that needs alertness until you can do||
1935|083|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1935|084|P|are using marijuana (cannabis).||
1935|085|P|   Lofexidine may cause a condition that affects the heart rhythm||
1935|086|P|(QT prolongation). QT prolongation can rarely cause serious||
1935|087|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1935|088|P|as severe dizziness, fainting) that need medical attention right||
1935|089|P|away.||
1935|090|P|   The risk of QT prolongation may be increased if you have||
1935|091|P|certain medical conditions or are taking other drugs that may||
1935|092|P|cause QT prolongation. Before using lofexidine, tell your doctor||
1935|093|P|or pharmacist of all the drugs you take and if you have any of||
1935|094|P|the following conditions: certain heart problems (heart failure,||
1935|095|P|slow heartbeat, QT prolongation in the EKG), family history of||
1935|096|P|certain heart problems (QT prolongation in the EKG, sudden||
1935|097|P|cardiac death).||
1935|098|P|   Low levels of potassium or magnesium in the blood may also||
1935|099|P|increase your risk of QT prolongation. This risk may increase if||
1935|100|P|you use certain drugs (such as diuretics/"water pills") or if you||
1935|101|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1935|102|P|Talk to your doctor about using lofexidine safely.||
1935|103|P|   Too much sweating, diarrhea, or vomiting may cause dehydration||
1935|104|P|and increase your risk of lightheadedness. Report prolonged||
1935|105|P|diarrhea or vomiting to your doctor. Be sure to drink enough||
1935|106|P|fluids to prevent dehydration unless your doctor directs you||
1935|107|P|otherwise.||
1935|108|P|   Before having surgery, tell your doctor or dentist about all||
1935|109|P|the products you use (including prescription drugs,||
1935|110|P|nonprescription drugs, and herbal products).||
1935|111|P|   Older adults may be more sensitive to the side effects of this||
1935|112|P|drug, especially QT prolongation (see above).||
1935|113|P|   During pregnancy, this medication should be used only when||
1935|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
1935|115|P|   It is unknown if lofexidine passes into breast milk. Consult||
1935|116|P|your doctor before breastfeeding.||
1935|117|B|||
1935|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1935|119|I|medications work or increase your risk for serious side effects.||
1935|120|I|This document does not contain all possible drug interactions.||
1935|121|I|Keep a list of all the products you use (including||
1935|122|I|prescription/nonprescription drugs and herbal products) and share||
1935|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
1935|124|I|the dosage of any medicines without your doctor's approval.||
1935|125|I|   Tell your doctor or pharmacist if you are taking other||
1935|126|I|products that cause drowsiness such as alcohol, marijuana||
1935|127|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1935|128|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1935|129|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1935|130|I|diphenhydramine).||
1935|131|I|   Check the labels on all your medicines (such as allergy or||
1935|132|I|cough-and-cold products) because they may contain ingredients||
1935|133|I|that cause drowsiness. Ask your pharmacist about using those||
1935|134|I|products safely.||
1935|135|B|||
1935|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1935|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1935|138|O|poison control center right away. US residents can call||
1935|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1935|140|O|Symptoms of overdose may include: severe dizziness/drowsiness.||
1935|141|B|||
1935|142|N|NOTES:  Do not share this medication with others.||
1935|143|N|   Tell all of your doctors that you use this medication and have||
1935|144|N|regularly used opioids, especially in cases of emergency||
1935|145|N|treatment.||
1935|146|N|   Lab and/or medical tests (such as blood pressure, pulse)||
1935|147|N|should be done while you are taking this medication. Keep all||
1935|148|N|medical and lab appointments. Consult your doctor for more||
1935|149|N|details.||
1935|150|B|||
1935|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1935|152|D|remember. If it is near the time of the next dose, skip the||
1935|153|D|missed dose. Take your next dose at the regular time. Do not||
1935|154|D|double the dose to catch up.||
1935|155|B|||
1935|156|R|STORAGE:  Store in the original bottle at room temperature away||
1935|157|R|from light and moisture. Do not store in the bathroom. Keep the||
1935|158|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1935|159|R|when not in use. Keep all medications away from children and||
1935|160|R|pets.||
1935|161|R|   Do not flush medications down the toilet or pour them into a||
1935|162|R|drain unless instructed to do so. Properly discard this product||
1935|163|R|when it is expired or no longer needed. Consult your pharmacist||
1935|164|R|or local waste disposal company.||
1935|165|B|||
1935|166|A|Information last revised July 2024.||
1935|167|A|Copyright(c) 2025 First Databank, Inc.||
1935|168|B|||
1936|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1936|002|Z|does NOT have all possible information about this product. This||
1936|003|Z|information does not assure that this product is safe, effective,||
1936|004|Z|or appropriate for you. This information is not individual||
1936|005|Z|medical advice and does not substitute for the advice of your||
1936|006|Z|health care professional. Always ask your health care||
1936|007|Z|professional for complete information about this product and your||
1936|008|Z|specific health needs.||
1936|009|B|||
1936|010|T|ESTRADIOL INSERT - VAGINAL||
1936|011|F|(ES-tra-DYE-ol)||
1936|012|B|||
1936|013|C|COMMON BRAND NAME(S): Imvexxy||
1936|014|B|||
1936|015|W|WARNING:  Estrogens, either used alone or with another hormone||
1936|016|W|(progestin), have rarely caused very serious side effects.||
1936|017|W|Discuss the risks and benefits of hormone treatment with your||
1936|018|W|doctor. Estrogens should not be used to prevent heart disease or||
1936|019|W|dementia.||
1936|020|W|   Estrogens can increase the risk of cancer of the uterus||
1936|021|W|(endometrial cancer). Taking a progestin as directed by your||
1936|022|W|doctor can help decrease this risk. Tell your doctor right away||
1936|023|W|if you have any unusual vaginal bleeding.||
1936|024|W|   In postmenopausal women, estrogens, taken with or without a||
1936|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
1936|026|W|stroke, dementia, and serious blood clots. When used along with a||
1936|027|W|progestin, estrogens also increase the risk of heart disease||
1936|028|W|(such as heart attacks).||
1936|029|W|   The risk for serious side effects may depend on the dose of||
1936|030|W|estrogen and the length of time it is used. This medication||
1936|031|W|should be used at the lowest effective dose and for the shortest||
1936|032|W|amount of time. Discuss the use of this medication with your||
1936|033|W|doctor and check with him/her regularly (for example, every 3 to||
1936|034|W|6 months) to see if you still need to use this medication. If you||
1936|035|W|will be using this medication long-term, you should have regular||
1936|036|W|complete physical exams (for example, once a year) as directed by||
1936|037|W|your doctor. See also Notes section.||
1936|038|B|||
1936|039|U|USES:  This medication is a hormone (estrogen). It is used by||
1936|040|U|women to help reduce vaginal symptoms of menopause (such as||
1936|041|U|vaginal dryness/burning/itching). These symptoms are caused by||
1936|042|U|the body making less estrogen. When treating only vaginal||
1936|043|U|symptoms of menopause, products applied directly inside the||
1936|044|U|vagina (such as this medication) should be used first. Estrogens||
1936|045|U|that are taken by mouth, absorbed through the skin, or injected||
1936|046|U|may have greater risks of side effects due to more estrogen being||
1936|047|U|absorbed.||
1936|048|B|||
1936|049|H|HOW TO USE:  Read the Patient Information Leaflet and||
1936|050|H|Instructions for Use if available from your pharmacist before you||
1936|051|H|start using this medication and each time you get a refill. If||
1936|052|H|you have any questions, ask your doctor or pharmacist.||
1936|053|H|   Wash and dry your hands before handling the insert. Select the||
1936|054|H|best position for vaginal insertion that is most comfortable for||
1936|055|H|you. Hold the insert with the larger end between your fingers and||
1936|056|H|place it about 2 inches into your vagina as directed. Use this||
1936|057|H|medication vaginally as directed by your doctor, usually once||
1936|058|H|daily for the first 2 weeks, then 2 times a week, every 3 to 4||
1936|059|H|days (for example, every Monday and Thursday).||
1936|060|H|   The dosage is based on your medical condition and response to||
1936|061|H|treatment.||
1936|062|H|   Use this medication regularly to get the most benefit from it.||
1936|063|H|To help you remember, mark your calendar with a reminder. Do not||
1936|064|H|increase your dose or use this medication more often or for||
1936|065|H|longer than prescribed.||
1936|066|H|   Tell your doctor if your condition does not get better or if||
1936|067|H|it gets worse.||
1936|068|B|||
1936|069|S|SIDE EFFECTS:  See also Warning section.||
1936|070|S|   Nausea/vomiting, bloating, diarrhea, breast tenderness,||
1936|071|S|headache, or weight changes may occur. If any of these effects||
1936|072|S|last or get worse, tell your doctor or pharmacist promptly.||
1936|073|S|   Remember that this medication has been prescribed because your||
1936|074|S|doctor has judged that the benefit to you is greater than the||
1936|075|S|risk of side effects. Many people using this medication do not||
1936|076|S|have serious side effects.||
1936|077|S|   Tell your doctor right away if you have any serious side||
1936|078|S|effects, including: mental/mood changes (such as new/worsening||
1936|079|S|depression), lumps in the breast, unusual changes in vaginal||
1936|080|S|bleeding (such as continuous spotting, sudden heavy bleeding),||
1936|081|S|increased or new vaginal irritation/itching/odor/discharge, signs||
1936|082|S|of liver problems (such as nausea/vomiting that doesn't stop,||
1936|083|S|loss of appetite, stomach/abdominal pain, yellowing eyes/skin,||
1936|084|S|dark urine), swelling hands/ankles/feet, symptoms of high blood||
1936|085|S|sugar (such as increased thirst/urination).||
1936|086|S|   This medication may rarely cause serious (sometimes fatal)||
1936|087|S|problems from blood clots (such as heart attack, stroke, blood||
1936|088|S|clots in the lungs or legs). Get medical help right away if you||
1936|089|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
1936|090|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
1936|091|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1936|092|S|trouble speaking, weakness on one side of the body, sudden vision||
1936|093|S|changes.||
1936|094|S|   A very serious allergic reaction to this product is rare.||
1936|095|S|However, get medical help right away if you notice any symptoms||
1936|096|S|of a serious allergic reaction, including: rash, itching/swelling||
1936|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1936|098|S|breathing.||
1936|099|S|   This is not a complete list of possible side effects. If you||
1936|100|S|notice other effects not listed above, contact your doctor or||
1936|101|S|pharmacist.||
1936|102|S|   In the US -||
1936|103|S|   Call your doctor for medical advice about side effects. You||
1936|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1936|105|S|www.fda.gov/medwatch.||
1936|106|S|   In Canada - Call your doctor for medical advice about side||
1936|107|S|effects. You may report side effects to Health Canada at||
1936|108|S|1-866-234-2345.||
1936|109|B|||
1936|110|P|PRECAUTIONS:  Before using estradiol, tell your doctor or||
1936|111|P|pharmacist if you are allergic to it; or if you have any other||
1936|112|P|allergies. This product may contain inactive ingredients, which||
1936|113|P|can cause allergic reactions or other problems. Talk to your||
1936|114|P|pharmacist for more details.||
1936|115|P|   Before using this medication, tell your doctor or pharmacist||
1936|116|P|your medical history, especially of: blood clots (for example, in||
1936|117|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
1936|118|P|C or protein S deficiency), high blood pressure, abnormal breast||
1936|119|P|exam, cancer (especially endometrial or breast cancer), high||
1936|120|P|cholesterol or triglyceride (blood fat) levels, mental/mood||
1936|121|P|disorders (such as dementia, depression), diabetes, family or||
1936|122|P|personal history of a certain swelling disorder (angioedema),||
1936|123|P|gallbladder problems, severe headaches/migraines, heart problems||
1936|124|P|(such as heart valve disease, irregular heartbeat, previous heart||
1936|125|P|attack), history of yellowing eyes/skin (jaundice) during||
1936|126|P|pregnancy or while using hormonal birth control (such as pills,||
1936|127|P|patch), kidney disease, liver disease (including tumors), stroke,||
1936|128|P|swelling (edema), thyroid problems, unexplained vaginal bleeding,||
1936|129|P|a certain hormone problem (hypoparathyroidism).||
1936|130|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
1936|131|P|further increase your risk of stroke, blood clots, high blood||
1936|132|P|pressure, and heart attack, especially in women older than 35.||
1936|133|P|   Tell your doctor if you just had or will be having surgery, or||
1936|134|P|if you will be confined to a chair or bed for a long time (such||
1936|135|P|as a long plane flight). These conditions increase your risk of||
1936|136|P|getting blood clots, especially if you are using an estrogen||
1936|137|P|product. You may need to stop this medication for a time or take||
1936|138|P|special precautions.||
1936|139|P|   Before having surgery, tell your doctor or dentist about all||
1936|140|P|the products you use (including prescription drugs,||
1936|141|P|nonprescription drugs, and herbal products).||
1936|142|P|   This medication may cause blotchy, dark areas on your skin||
1936|143|P|(melasma). Sunlight may worsen this effect. Avoid prolonged sun||
1936|144|P|exposure, sunlamps, and tanning booths. Use a sunscreen, and wear||
1936|145|P|protective clothing when outdoors.||
1936|146|P|   If you are nearsighted or wear contact lenses, you may develop||
1936|147|P|vision problems or trouble wearing your contact lenses. Contact||
1936|148|P|your eye doctor if these problems occur.||
1936|149|P|   This medication should not be used during pregnancy. If you||
1936|150|P|become pregnant or think you may be pregnant, tell your doctor||
1936|151|P|right away.||
1936|152|P|   This medication passes into breast milk. However, it is||
1936|153|P|unlikely to be used by a breastfeeding woman. Consult your doctor||
1936|154|P|if you have questions about breastfeeding while using this||
1936|155|P|medication.||
1936|156|B|||
1936|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1936|158|I|medications work or increase your risk for serious side effects.||
1936|159|I|This document does not contain all possible drug interactions.||
1936|160|I|Keep a list of all the products you use (including||
1936|161|I|prescription/nonprescription drugs and herbal products) and share||
1936|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
1936|163|I|the dosage of any medicines without your doctor's approval.||
1936|164|I|   Some products that may interact with this drug are:||
1936|165|I|fulvestrant, ospemifene, raloxifene, tamoxifen, toremifene,||
1936|166|I|tranexamic acid.||
1936|167|I|   This medication may interfere with certain lab tests, possibly||
1936|168|I|causing false test results. Make sure lab personnel and all your||
1936|169|I|doctors know you use this drug.||
1936|170|B|||
1936|171|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1936|172|O|has overdosed and has serious symptoms such as passing out or||
1936|173|O|trouble breathing, call 911. Otherwise, call a poison control||
1936|174|O|center right away. US residents can call 1-800-222-1222. Canada||
1936|175|O|residents can call 1-844-764-7669. Symptoms of overdose may||
1936|176|O|include: severe nausea/vomiting, unusual vaginal bleeding.||
1936|177|B|||
1936|178|N|NOTES:  Do not share this medication with others.||
1936|179|N|   You should have regular complete physical exams including||
1936|180|N|blood pressure, breast exam, pelvic exam, and screening for||
1936|181|N|cervical cancer (Pap smear). Follow your doctor's instructions||
1936|182|N|for examining your breasts, and report any lumps right away. Keep||
1936|183|N|all medical and lab appointments. Consult your doctor for more||
1936|184|N|details.||
1936|185|N|   Preventing or controlling high blood pressure, high||
1936|186|N|cholesterol, and diabetes can help to reduce your chances of||
1936|187|N|heart disease and stroke. Lifestyle changes that can help to||
1936|188|N|control or prevent these diseases include reducing stress, eating||
1936|189|N|a low fat/salt diet, losing weight if overweight, exercising||
1936|190|N|regularly, and stopping smoking. Keep your mind active with||
1936|191|N|mental exercises (such as reading, solving crossword puzzles) to||
1936|192|N|help prevent dementia. Talk to your doctor about lifestyle||
1936|193|N|changes that might benefit you.||
1936|194|B|||
1936|195|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1936|196|D|If it is near the time of the next dose, skip the missed dose.||
1936|197|D|Use your next dose at the regular time. Do not double the dose to||
1936|198|D|catch up.||
1936|199|B|||
1936|200|R|STORAGE:  Store at room temperature. Keep all medications away||
1936|201|R|from children and pets.||
1936|202|R|   Do not flush medications down the toilet or pour them into a||
1936|203|R|drain unless instructed to do so. Properly discard this product||
1936|204|R|when it is expired or no longer needed. Consult your pharmacist||
1936|205|R|or local waste disposal company.||
1936|206|B|||
1936|207|A|Information last revised November 2025.||
1936|208|A|Copyright(c) 2025 First Databank, Inc.||
1936|209|B|||
1937|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1937|002|Z|does NOT have all possible information about this product. This||
1937|003|Z|information does not assure that this product is safe, effective,||
1937|004|Z|or appropriate for you. This information is not individual||
1937|005|Z|medical advice and does not substitute for the advice of your||
1937|006|Z|health care professional. Always ask your health care||
1937|007|Z|professional for complete information about this product and your||
1937|008|Z|specific health needs.||
1937|009|B|||
1937|010|T|BINIMETINIB - ORAL||
1937|011|F|(BIN-i-ME-ti-nib)||
1937|012|B|||
1937|013|C|COMMON BRAND NAME(S): Mektovi||
1937|014|B|||
1937|015|U|USES:  This medication is used to treat certain types of cancer||
1937|016|U|(such as lung cancer, melanoma skin cancer). Binimetinib belongs||
1937|017|U|to a class of drugs known as kinase inhibitors. It works by||
1937|018|U|slowing or stopping the growth of cancer cells.||
1937|019|B|||
1937|020|H|HOW TO USE:  Read the Medication Guide and, if available, the||
1937|021|H|Patient Information Leaflet provided by your pharmacist before||
1937|022|H|you start taking binimetinib and each time you get a refill. If||
1937|023|H|you have any questions, ask your doctor or pharmacist.||
1937|024|H|   Take this medication by mouth with or without food as directed||
1937|025|H|by your doctor, usually twice daily (about 12 hours apart).||
1937|026|H|   If you vomit after taking a dose, do not take another dose at||
1937|027|H|that time. Take your next dose at the regular time.||
1937|028|H|   The dosage is based on your medical condition and response to||
1937|029|H|treatment.||
1937|030|H|   Take this medication regularly to get the most benefit from||
1937|031|H|it. To help you remember, take it at the same times each day.||
1937|032|H|   Do not increase your dose or use this drug more often or for||
1937|033|H|longer than prescribed. Your condition will not improve any||
1937|034|H|faster, and your risk of side effects will increase.||
1937|035|H|   Since this drug can be absorbed through the skin and lungs and||
1937|036|H|may harm an unborn baby, women who are pregnant or who may become||
1937|037|H|pregnant should not handle this medication or breathe the dust||
1937|038|H|from the tablets.||
1937|039|B|||
1937|040|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, tiredness, abdominal||
1937|041|S|pain, constipation, or dizziness may occur. If any of these||
1937|042|S|effects last or get worse, tell your doctor or pharmacist||
1937|043|S|promptly.||
1937|044|S|   People using this medication may have serious side effects.||
1937|045|S|However, you have been prescribed this drug because your doctor||
1937|046|S|has judged that the benefit to you is greater than the risk of||
1937|047|S|side effects. Careful monitoring by your doctor may decrease your||
1937|048|S|risk.||
1937|049|S|   Tell your doctor right away if you have any serious side||
1937|050|S|effects, including: easy bleeding/bruising, black/bloody stools,||
1937|051|S|vomit that contains blood or looks like coffee grounds, muscle||
1937|052|S|pain/tenderness/weakness, signs of heart failure (such as||
1937|053|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
1937|054|S|unusual/sudden weight gain), vision changes (such as blurred||
1937|055|S|vision, decreased vision, seeing halos/colored dots), eye||
1937|056|S|pain/swelling/redness, signs of liver problems (such as||
1937|057|S|nausea/vomiting that doesn't stop, loss of appetite,||
1937|058|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1937|059|S|   Although this medication is used to treat certain skin||
1937|060|S|cancers, it may rarely cause new skin or other cancers. Tell your||
1937|061|S|doctor right away if you notice unusual skin changes (such as||
1937|062|S|skin sores/lumps, warts, change in the size/color of a mole).||
1937|063|S|Your doctor should check your skin before starting treatment,||
1937|064|S|every 2 months during treatment, and for up to 6 months after||
1937|065|S|stopping this medication.||
1937|066|S|   This medication may rarely cause serious problems from blood||
1937|067|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1937|068|S|legs). You may be at increased risk for blood clots if you have a||
1937|069|S|history of blood clots, or if you are immobile (such as on very||
1937|070|S|long plane flights or being bedridden). If you use||
1937|071|S|estrogen-containing products, these may also increase your risk.||
1937|072|S|Before using this medication, if you have any of these conditions||
1937|073|S|report them to your doctor or pharmacist. Get medical help right||
1937|074|S|away if any of these side effects occur: shortness of||
1937|075|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
1937|076|S|sweating, confusion, sudden dizziness/fainting,||
1937|077|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
1937|078|S|trouble speaking, weakness on one side of the body, sudden vision||
1937|079|S|changes.||
1937|080|S|   A very serious allergic reaction to this drug is rare.||
1937|081|S|However, get medical help right away if you notice any symptoms||
1937|082|S|of a serious allergic reaction, including: rash, itching/swelling||
1937|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1937|084|S|breathing.||
1937|085|S|   This is not a complete list of possible side effects. If you||
1937|086|S|notice other effects not listed above, contact your doctor or||
1937|087|S|pharmacist.||
1937|088|S|   In the US -||
1937|089|S|   Call your doctor for medical advice about side effects. You||
1937|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1937|091|S|www.fda.gov/medwatch.||
1937|092|S|   In Canada - Call your doctor for medical advice about side||
1937|093|S|effects. You may report side effects to Health Canada at||
1937|094|S|1-866-234-2345.||
1937|095|B|||
1937|096|P|PRECAUTIONS:  Before taking binimetinib, tell your doctor or||
1937|097|P|pharmacist if you are allergic to it; or if you have any other||
1937|098|P|allergies. This product may contain inactive ingredients, which||
1937|099|P|can cause allergic reactions or other problems. Talk to your||
1937|100|P|pharmacist for more details.||
1937|101|P|   Before using this medication, tell your doctor or pharmacist||
1937|102|P|your medical history, especially of: bleeding/blood problems,||
1937|103|P|high blood pressure, heart disease (such as heart failure), eye||
1937|104|P|problems, kidney problems, liver problems.||
1937|105|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
1937|106|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
1937|107|P|use machinery, or do anything that needs alertness or clear||
1937|108|P|vision until you can do it safely. Limit alcoholic beverages.||
1937|109|P|Talk to your doctor if you are using marijuana (cannabis).||
1937|110|P|   Before having surgery, tell your doctor or dentist about all||
1937|111|P|the products you use (including prescription drugs,||
1937|112|P|nonprescription drugs, and herbal products).||
1937|113|P|   Since this drug can be absorbed through the skin and lungs and||
1937|114|P|may harm an unborn baby, women who are pregnant or who may become||
1937|115|P|pregnant should not handle this medication or breathe the dust||
1937|116|P|from the tablets.||
1937|117|P|   Tell your doctor if you are pregnant or plan to become||
1937|118|P|pregnant. You should not become pregnant while using binimetinib.||
1937|119|P|Binimetinib may harm an unborn baby. Your doctor should order a||
1937|120|P|pregnancy test before you start this medication. Ask about||
1937|121|P|reliable forms of birth control while using this medication and||
1937|122|P|for 30 days after the last dose. If you become pregnant, talk to||
1937|123|P|your doctor right away about the risks and benefits of this||
1937|124|P|medication.||
1937|125|P|   It is unknown if this drug passes into breast milk. Because of||
1937|126|P|the possible risk to the infant, breastfeeding is not recommended||
1937|127|P|while using this drug and for 3 days after the last dose. Consult||
1937|128|P|your doctor before breastfeeding.||
1937|129|B|||
1937|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1937|131|I|medications work or increase your risk for serious side effects.||
1937|132|I|This document does not contain all possible drug interactions.||
1937|133|I|Keep a list of all the products you use (including||
1937|134|I|prescription/nonprescription drugs and herbal products) and share||
1937|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
1937|136|I|the dosage of any medicines without your doctor's approval.||
1937|137|B|||
1937|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1937|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1937|140|O|poison control center right away. US residents can call||
1937|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1937|142|B|||
1937|143|N|NOTES:  Do not share this medication with others.||
1937|144|N|   Lab and/or medical tests (such as BRAF gene testing,||
1937|145|N|heart/kidney/liver function, skin/eye exams, CPK levels, complete||
1937|146|N|blood count) should be done before you start taking this||
1937|147|N|medication and while you are taking it. Keep all medical and lab||
1937|148|N|appointments.||
1937|149|B|||
1937|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1937|151|D|remember. If it is within 6 hours of the next dose, skip the||
1937|152|D|missed dose. Take your next dose at the regular time. Do not||
1937|153|D|double the dose to catch up.||
1937|154|B|||
1937|155|R|STORAGE:  Store at room temperature away from light and moisture.||
1937|156|R|Keep all medications away from children and pets.||
1937|157|R|   Do not flush medications down the toilet or pour them into a||
1937|158|R|drain unless instructed to do so. Properly discard this product||
1937|159|R|when it is expired or no longer needed. Consult your pharmacist||
1937|160|R|or local waste disposal company.||
1937|161|B|||
1937|162|A|Information last revised July 2024.||
1937|163|A|Copyright(c) 2025 First Databank, Inc.||
1937|164|B|||
1938|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1938|002|Z|does NOT have all possible information about this product. This||
1938|003|Z|information does not assure that this product is safe, effective,||
1938|004|Z|or appropriate for you. This information is not individual||
1938|005|Z|medical advice and does not substitute for the advice of your||
1938|006|Z|health care professional. Always ask your health care||
1938|007|Z|professional for complete information about this product and your||
1938|008|Z|specific health needs.||
1938|009|B|||
1938|010|T|ENCORAFENIB - ORAL||
1938|011|F|(EN-koe-RAF-e-nib)||
1938|012|B|||
1938|013|C|COMMON BRAND NAME(S): Braftovi||
1938|014|B|||
1938|015|U|USES:  Encorafenib is used to treat certain types of cancer (such||
1938|016|U|as lung cancer, melanoma skin cancer, cancer in the colon or||
1938|017|U|rectum). Encorafenib belongs to a class of drugs known as kinase||
1938|018|U|inhibitors. It works by slowing or stopping the growth of cancer||
1938|019|U|cells.||
1938|020|B|||
1938|021|H|HOW TO USE:  Read the Medication Guide provided by your||
1938|022|H|pharmacist before you start taking encorafenib and each time you||
1938|023|H|get a refill. If you have any questions, ask your doctor or||
1938|024|H|pharmacist.||
1938|025|H|   Take this medication by mouth with or without food as directed||
1938|026|H|by your doctor, usually once daily.||
1938|027|H|   If you vomit after taking a dose, do not take another dose at||
1938|028|H|that time. Take your next dose at the regular time.||
1938|029|H|   The dosage is based on your medical condition, response to||
1938|030|H|treatment, and other medications you may be taking. Be sure to||
1938|031|H|tell your doctor and pharmacist about all the products you use||
1938|032|H|(including prescription drugs, nonprescription drugs, and herbal||
1938|033|H|products).||
1938|034|H|   Take this medication regularly to get the most benefit from||
1938|035|H|it. To help you remember, take it at the same time each day.||
1938|036|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1938|037|H|using this medication unless your doctor or pharmacist says you||
1938|038|H|may do so safely. Grapefruit can increase the chance of side||
1938|039|H|effects with this medicine. Ask your doctor or pharmacist for||
1938|040|H|more details.||
1938|041|H|   Do not increase your dose or use this drug more often or for||
1938|042|H|longer than prescribed. Your condition will not improve any||
1938|043|H|faster, and your risk of side effects will increase.||
1938|044|H|   Since this drug can be absorbed through the skin and lungs and||
1938|045|H|may harm an unborn baby, women who are pregnant or who may become||
1938|046|H|pregnant should not handle this medication or breathe the dust||
1938|047|H|from the capsules.||
1938|048|B|||
1938|049|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, tiredness,||
1938|050|S|abdominal pain, joint pain or swelling, dry/itching skin,||
1938|051|S|constipation, or dizziness may occur. If any of these effects||
1938|052|S|last or get worse, tell your doctor or pharmacist promptly.||
1938|053|S|   Temporary hair loss may occur. Normal hair growth should||
1938|054|S|return if treatment is stopped.||
1938|055|S|   People using this medication may have serious side effects.||
1938|056|S|However, you have been prescribed this drug because your doctor||
1938|057|S|has judged that the benefit to you is greater than the risk of||
1938|058|S|side effects. Careful monitoring by your doctor may decrease your||
1938|059|S|risk.||
1938|060|S|   Tell your doctor right away if you have any serious side||
1938|061|S|effects, including: easy bleeding/bruising (such as bleeding of||
1938|062|S|the gums), black/bloody stools, vomit that contains blood or||
1938|063|S|looks like coffee grounds, vision changes (such as blurred||
1938|064|S|vision, decreased vision, seeing halos/colored dots), signs of||
1938|065|S|liver problems (such as nausea/vomiting that doesn't stop, loss||
1938|066|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1938|067|S|urine), symptoms of heart failure (such as shortness of breath,||
1938|068|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
1938|069|S|gain).||
1938|070|S|   Although this medication is used to treat certain skin||
1938|071|S|cancers, it may rarely cause new skin or other cancers. Tell your||
1938|072|S|doctor right away if you notice unusual skin changes (such as||
1938|073|S|skin sores/lumps, warts, change in the size/color of a mole).||
1938|074|S|Your doctor should check your skin before starting treatment,||
1938|075|S|every 2 months during treatment, and for up to 6 months after||
1938|076|S|stopping this medication.||
1938|077|S|   Get medical help right away if you have any very serious side||
1938|078|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1938|079|S|fainting, signs of bleeding in the brain (such as severe||
1938|080|S|headache, weakness on one side of the body, sudden vision||
1938|081|S|changes, trouble speaking, seizures, confusion).||
1938|082|S|   A very serious allergic reaction to this drug is rare.||
1938|083|S|However, get medical help right away if you notice any symptoms||
1938|084|S|of a serious allergic reaction, including: rash, itching/swelling||
1938|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1938|086|S|breathing.||
1938|087|S|   This is not a complete list of possible side effects. If you||
1938|088|S|notice other effects not listed above, contact your doctor or||
1938|089|S|pharmacist.||
1938|090|S|   In the US -||
1938|091|S|   Call your doctor for medical advice about side effects. You||
1938|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1938|093|S|www.fda.gov/medwatch.||
1938|094|S|   In Canada - Call your doctor for medical advice about side||
1938|095|S|effects. You may report side effects to Health Canada at||
1938|096|S|1-866-234-2345.||
1938|097|B|||
1938|098|P|PRECAUTIONS:  Before taking encorafenib, tell your doctor or||
1938|099|P|pharmacist if you are allergic to it; or if you have any other||
1938|100|P|allergies. This product may contain inactive ingredients, which||
1938|101|P|can cause allergic reactions or other problems. Talk to your||
1938|102|P|pharmacist for more details.||
1938|103|P|   Before using this medication, tell your doctor or pharmacist||
1938|104|P|your medical history, especially of: bleeding problems, eye||
1938|105|P|problems, liver problems.||
1938|106|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
1938|107|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
1938|108|P|use machinery, or do anything that needs alertness or clear||
1938|109|P|vision until you can do it safely. Limit alcoholic beverages.||
1938|110|P|Talk to your doctor if you are using marijuana (cannabis).||
1938|111|P|   Encorafenib may cause a condition that affects the heart||
1938|112|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1938|113|P|serious (rarely fatal) fast/irregular heartbeat and other||
1938|114|P|symptoms (such as severe dizziness, fainting) that need medical||
1938|115|P|attention right away.||
1938|116|P|   The risk of QT prolongation may be increased if you have||
1938|117|P|certain medical conditions or are taking other drugs that may||
1938|118|P|cause QT prolongation. Before using encorafenib, tell your doctor||
1938|119|P|or pharmacist of all the drugs you take and if you have any of||
1938|120|P|the following conditions: certain heart problems (heart failure,||
1938|121|P|slow heartbeat, QT prolongation in the EKG), family history of||
1938|122|P|certain heart problems (QT prolongation in the EKG, sudden||
1938|123|P|cardiac death).||
1938|124|P|   Low levels of potassium or magnesium in the blood may also||
1938|125|P|increase your risk of QT prolongation. This risk may increase if||
1938|126|P|you use certain drugs (such as diuretics/"water pills") or if you||
1938|127|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1938|128|P|Talk to your doctor about using encorafenib safely.||
1938|129|P|   Older adults may be more sensitive to the side effects of this||
1938|130|P|drug, especially QT prolongation (see above).||
1938|131|P|   Before having surgery, tell your doctor or dentist about all||
1938|132|P|the products you use (including prescription drugs,||
1938|133|P|nonprescription drugs, and herbal products).||
1938|134|P|   Since this drug can be absorbed through the skin and lungs and||
1938|135|P|may harm an unborn baby, women who are pregnant or who may become||
1938|136|P|pregnant should not handle this medication or breathe the dust||
1938|137|P|from the capsules.||
1938|138|P|   Tell your doctor if you are pregnant or plan to become||
1938|139|P|pregnant. You should not become pregnant while using encorafenib.||
1938|140|P|Encorafenib may harm an unborn baby. Your doctor should order a||
1938|141|P|pregnancy test before you start this medication. Ask about||
1938|142|P|reliable forms of non-hormonal birth control (such as condoms,||
1938|143|P|diaphragm with spermicide) while using this medication and for 2||
1938|144|P|weeks after the last dose. If you become pregnant, talk to your||
1938|145|P|doctor right away about the risks and benefits of this||
1938|146|P|medication.||
1938|147|P|   It is unknown if this drug passes into breast milk. Because of||
1938|148|P|the possible risk to the infant, breastfeeding is not recommended||
1938|149|P|while using this drug and for 2 weeks after the last dose.||
1938|150|P|Consult your doctor before breastfeeding.||
1938|151|B|||
1938|152|I|DRUG INTERACTIONS:  See also How to Use section.||
1938|153|I|   Drug interactions may change how your medications work or||
1938|154|I|increase your risk for serious side effects. This document does||
1938|155|I|not contain all possible drug interactions. Keep a list of all||
1938|156|I|the products you use (including prescription/nonprescription||
1938|157|I|drugs and herbal products) and share it with your doctor and||
1938|158|I|pharmacist. Do not start, stop, or change the dosage of any||
1938|159|I|medicines without your doctor's approval.||
1938|160|I|   Other medications can affect the removal of encorafenib from||
1938|161|I|your body, which may affect how encorafenib works. Examples||
1938|162|I|include azole antifungals (such as itraconazole, ketoconazole),||
1938|163|I|certain HIV protease inhibitors (such as atazanavir), macrolide||
1938|164|I|antibiotics (such as erythromycin), rifamycins (such as rifampin,||
1938|165|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
1938|166|I|as carbamazepine, phenytoin), among others.||
1938|167|I|   This medication can speed up or slow down the removal of other||
1938|168|I|medications from your body, which may affect how they work.||
1938|169|I|Examples of affected drugs include doravirine, elagolix,||
1938|170|I|elbasvir, etravirine, grazoprevir, lenacapavir, lurasidone,||
1938|171|I|nisoldipine, praziquantel, ranolazine, rilpivirine, tamoxifen,||
1938|172|I|among others.||
1938|173|I|   This medication may decrease the effectiveness of hormonal||
1938|174|I|birth control such as pills, patch, or ring. This could cause||
1938|175|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1938|176|I|use reliable backup birth control methods while using this||
1938|177|I|medication. Also tell your doctor if you have any new spotting or||
1938|178|I|breakthrough bleeding, because these may be signs that your birth||
1938|179|I|control is not working well.||
1938|180|B|||
1938|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1938|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1938|183|O|poison control center right away. US residents can call||
1938|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1938|185|B|||
1938|186|N|NOTES:  Do not share this medication with others.||
1938|187|N|   Lab and/or medical tests (such as heart/liver function,||
1938|188|N|skin/eye exams, complete blood count) should be done before you||
1938|189|N|start taking this medication and while you are taking it. Keep||
1938|190|N|all medical and lab appointments. Consult your doctor for more||
1938|191|N|details.||
1938|192|B|||
1938|193|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1938|194|D|remember. If it is within 12 hours of the next dose, skip the||
1938|195|D|missed dose. Take your next dose at the regular time. Do not||
1938|196|D|double the dose to catch up.||
1938|197|B|||
1938|198|R|STORAGE:  Store in the original bottle at room temperature away||
1938|199|R|from light and moisture. Do not store in the bathroom. Keep the||
1938|200|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1938|201|R|when not in use. Keep all medications away from children and||
1938|202|R|pets.||
1938|203|R|   Do not flush medications down the toilet or pour them into a||
1938|204|R|drain unless instructed to do so. Properly discard this product||
1938|205|R|when it is expired or no longer needed. Consult your pharmacist||
1938|206|R|or local waste disposal company.||
1938|207|B|||
1938|208|A|Information last revised July 2024.||
1938|209|A|Copyright(c) 2025 First Databank, Inc.||
1938|210|B|||
1940|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1940|002|Z|does NOT have all possible information about this product. This||
1940|003|Z|information does not assure that this product is safe, effective,||
1940|004|Z|or appropriate for you. This information is not individual||
1940|005|Z|medical advice and does not substitute for the advice of your||
1940|006|Z|health care professional. Always ask your health care||
1940|007|Z|professional for complete information about this product and your||
1940|008|Z|specific health needs.||
1940|009|B|||
1940|010|T|INSULIN ASPART (NIACINAMIDE) - INJECTION||
1940|011|F|(IN-su-lin AS-part)||
1940|012|B|||
1940|013|C|COMMON BRAND NAME(S): Fiasp||
1940|014|B|||
1940|015|U|USES:  Insulin aspart is used with a proper diet and exercise||
1940|016|U|program to control high blood sugar in people with diabetes.||
1940|017|U|Controlling high blood sugar helps prevent kidney damage,||
1940|018|U|blindness, nerve problems, loss of limbs, and sexual function||
1940|019|U|problems. Proper control of diabetes may also lessen your risk of||
1940|020|U|a heart attack or stroke.||
1940|021|U|   Insulin aspart is a man-made product that is similar to human||
1940|022|U|insulin. It replaces the insulin that your body would normally||
1940|023|U|make. Insulin aspart starts working faster and lasts for a||
1940|024|U|shorter time than regular insulin. It works by helping blood||
1940|025|U|sugar (glucose) get into cells so your body can use it for||
1940|026|U|energy. This medication is usually used with a medium- or||
1940|027|U|long-acting insulin product.||
1940|028|B|||
1940|029|H|HOW TO USE:  Read the Patient Information Leaflet and||
1940|030|H|Instructions for Use if available from your pharmacist before you||
1940|031|H|start using this medication and each time you get a refill. Ask||
1940|032|H|your health care professional how to prepare and use this||
1940|033|H|medication. If you have any questions, ask your doctor or||
1940|034|H|pharmacist.||
1940|035|H|   Inject this medication under the skin as directed by your||
1940|036|H|doctor, usually right before a meal or within 20 minutes after||
1940|037|H|starting a meal. Because this insulin is fast-acting, do not use||
1940|038|H|insulin aspart if you are unable to eat right after the injection||
1940|039|H|or if you have low blood sugar. Not eating right after a dose of||
1940|040|H|this insulin may lead to low blood sugar (hypoglycemia). The||
1940|041|H|injection is given in the stomach area, thigh, or back of the||
1940|042|H|upper arm. Do not inject into a vein or muscle because very low||
1940|043|H|blood sugar may occur.||
1940|044|H|   The dosage is based on your medical condition and response to||
1940|045|H|treatment. Measure each dose very carefully because even small||
1940|046|H|changes in the amount of insulin may have a large effect on your||
1940|047|H|blood sugar.||
1940|048|H|   Before using, check this product for particles or||
1940|049|H|discoloration. If either is present, do not use the insulin.||
1940|050|H|Before injecting each dose, clean the skin you are going to||
1940|051|H|inject into (the injection site) with rubbing alcohol. Change the||
1940|052|H|injection site each time to lessen injury under the skin (for||
1940|053|H|example, pits/lumps or thickened skin). Do not inject into skin||
1940|054|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
1940|055|H|not rub the injection site after a shot. Do not inject cold||
1940|056|H|insulin because this can be painful. The insulin container you||
1940|057|H|are currently using can be kept at room temperature. Learn how to||
1940|058|H|store and discard medical supplies safely.||
1940|059|H|   If you are directed to inject this insulin with an infusion||
1940|060|H|pump, read the instruction manual and directions that come with||
1940|061|H|the infusion pump. If you have any questions, ask your health||
1940|062|H|care professional. Avoid exposing the pump or its tubing to||
1940|063|H|direct sunlight or other heat sources. Do not dilute insulin if||
1940|064|H|you are using an insulin pump.||
1940|065|H|   Giving insulin aspart into a vein should only be done by a||
1940|066|H|health care professional. Very low blood sugar may result.||
1940|067|H|   Do not change brands or types of insulin without directions on||
1940|068|H|how to do so from your doctor.||
1940|069|H|   Do not share your pen device with another person, even if the||
1940|070|H|needle is changed. You may give other people a serious infection,||
1940|071|H|or get a serious infection from them.||
1940|072|H|   Use this medication regularly to get the most benefit from it.||
1940|073|H|To help you remember, use it at the same times each day.||
1940|074|H|   Tell your doctor if your condition does not get better or if||
1940|075|H|it gets worse (your blood sugar is too high or too low).||
1940|076|B|||
1940|077|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
1940|078|S|irritation) or weight gain may occur. If any of these effects||
1940|079|S|last or get worse, tell your doctor or pharmacist promptly.||
1940|080|S|   Remember that this medication has been prescribed because your||
1940|081|S|doctor has judged that the benefit to you is greater than the||
1940|082|S|risk of side effects. Many people using this medication do not||
1940|083|S|have serious side effects.||
1940|084|S|   Tell your doctor right away if you have any serious side||
1940|085|S|effects, including: signs of low potassium level in the blood||
1940|086|S|(such as muscle cramps, weakness, irregular heartbeat).||
1940|087|S|   This medication can cause low blood sugar (hypoglycemia). This||
1940|088|S|may occur if you do not get enough calories from food or if you||
1940|089|S|do unusually heavy exercise. Symptoms of low blood sugar include||
1940|090|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
1940|091|S|dizziness, or tingling hands/feet. It is a good habit to carry||
1940|092|S|glucose tablets or gel to treat low blood sugar. If you don't||
1940|093|S|have these reliable forms of glucose, rapidly raise your blood||
1940|094|S|sugar by eating a quick source of sugar such as table sugar,||
1940|095|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
1940|096|S|doctor right away about the reaction and the use of this product.||
1940|097|S|To help prevent low blood sugar, eat meals on a regular schedule,||
1940|098|S|and do not skip meals. Check with your doctor or pharmacist to||
1940|099|S|find out what you should do if you miss a meal.||
1940|100|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
1940|101|S|thirst/urination. If these symptoms occur, tell your doctor right||
1940|102|S|away. Your doctor may need to adjust your diabetes medication,||
1940|103|S|exercise program, or diet.||
1940|104|S|   A very serious allergic reaction to this drug is rare.||
1940|105|S|However, get medical help right away if you notice any symptoms||
1940|106|S|of a serious allergic reaction, including: rash, itching/swelling||
1940|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1940|108|S|breathing.||
1940|109|S|   This is not a complete list of possible side effects. If you||
1940|110|S|notice other effects not listed above, contact your doctor or||
1940|111|S|pharmacist.||
1940|112|S|   In the US -||
1940|113|S|   Call your doctor for medical advice about side effects. You||
1940|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1940|115|S|www.fda.gov/medwatch.||
1940|116|S|   In Canada - Call your doctor for medical advice about side||
1940|117|S|effects. You may report side effects to Health Canada at||
1940|118|S|1-866-234-2345.||
1940|119|B|||
1940|120|P|PRECAUTIONS:  Before using insulin aspart, tell your doctor or||
1940|121|P|pharmacist if you are allergic to it; or to other insulins; or if||
1940|122|P|you have any other allergies. This product may contain inactive||
1940|123|P|ingredients, which can cause allergic reactions or other||
1940|124|P|problems. Talk to your pharmacist for more details.||
1940|125|P|   Do not use this medication when you have low blood sugar||
1940|126|P|(hypoglycemia).||
1940|127|P|   Before using this medication, tell your doctor or pharmacist||
1940|128|P|your medical history, especially of: kidney disease, liver||
1940|129|P|disease, thyroid problems.||
1940|130|P|   You may experience blurred vision, dizziness, or drowsiness||
1940|131|P|due to extremely low or high blood sugar. Do not drive, use||
1940|132|P|machinery, or do anything that needs alertness or clear vision||
1940|133|P|until you can do it safely.||
1940|134|P|   Limit alcohol while taking this medication because it can||
1940|135|P|increase your risk of developing low blood sugar.||
1940|136|P|   It may be harder to control your blood sugar when your body is||
1940|137|P|stressed (such as due to fever, infection, injury, or surgery).||
1940|138|P|Consult your doctor because this may require a change in your||
1940|139|P|treatment plan, medications, or blood sugar testing.||
1940|140|P|   Before having surgery, tell your doctor or dentist about all||
1940|141|P|the products you use (including prescription drugs,||
1940|142|P|nonprescription drugs, and herbal products).||
1940|143|P|   Check your blood sugar before and after exercise. You may need||
1940|144|P|a snack beforehand.||
1940|145|P|   If traveling across time zones, ask your doctor about how to||
1940|146|P|adjust your insulin schedule. Take extra insulin and supplies||
1940|147|P|with you.||
1940|148|P|   Children may be more sensitive to the side effects of this||
1940|149|P|drug, especially low blood sugar.||
1940|150|P|   Older adults may be more sensitive to the side effects of this||
1940|151|P|drug, especially low blood sugar.||
1940|152|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
1940|153|P|cause or worsen diabetes. Discuss a plan with your doctor for||
1940|154|P|managing your blood sugar while pregnant. Your doctor may change||
1940|155|P|your diabetes treatment during your pregnancy (such as diet and||
1940|156|P|medications including insulin).||
1940|157|P|   This medication passes into breast milk, but is unlikely to||
1940|158|P|harm a nursing infant. Consult your doctor before breastfeeding.||
1940|159|P|Your insulin needs may change while breastfeeding.||
1940|160|B|||
1940|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1940|162|I|medications work or increase your risk for serious side effects.||
1940|163|I|This document does not contain all possible drug interactions.||
1940|164|I|Keep a list of all the products you use (including||
1940|165|I|prescription/nonprescription drugs and herbal products) and share||
1940|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
1940|167|I|the dosage of any medicines without your doctor's approval.||
1940|168|I|   Beta-blocker medications (such as metoprolol, propranolol,||
1940|169|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
1940|170|I|heartbeat you would usually feel when your blood sugar falls too||
1940|171|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
1940|172|I|dizziness, hunger, or sweating, are not affected by these drugs.||
1940|173|I|   Many drugs can affect your blood sugar, making it harder to||
1940|174|I|control. Before you start, stop, or change any medication, talk||
1940|175|I|with your doctor or pharmacist about how the medication may||
1940|176|I|affect your blood sugar. Check your blood sugar regularly as||
1940|177|I|directed and share the results with your doctor. Tell your doctor||
1940|178|I|right away if you have symptoms of high or low blood sugar. (See||
1940|179|I|also Side Effects section.) Your doctor may need to adjust your||
1940|180|I|diabetes medication, exercise program, or diet.||
1940|181|B|||
1940|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1940|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1940|184|O|poison control center right away. US residents can call||
1940|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1940|186|O|Symptoms of overdose may include: signs of low blood sugar such||
1940|187|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
1940|188|B|||
1940|189|N|NOTES:  Do not share this medication, needles, or syringes with||
1940|190|N|others.||
1940|191|N|   Attend a diabetes education program to learn more about how to||
1940|192|N|manage your diabetes with medications, diet, exercise, and||
1940|193|N|regular medical exams.||
1940|194|N|   Learn the symptoms of high and low blood sugar and how to||
1940|195|N|treat low blood sugar. Check your blood sugar regularly as||
1940|196|N|directed and share the results with your doctor.||
1940|197|N|   Lab and/or medical tests (such as liver/kidney function,||
1940|198|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
1940|199|N|should be done while you are using this medication. Keep all||
1940|200|N|medical and lab appointments.||
1940|201|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
1940|202|B|||
1940|203|D|MISSED DOSE:  It is very important to follow your insulin regimen||
1940|204|D|exactly. Ask your doctor ahead of time what you should do if you||
1940|205|D|miss a dose of insulin.||
1940|206|B|||
1940|207|R|STORAGE:  Store all unopened insulin products in the||
1940|208|R|refrigerator. Opened insulin aspart vials and prefilled pens may||
1940|209|R|be stored in the refrigerator or at room temperature. Opened||
1940|210|R|insulin aspart cartridges can only be stored at room temperature||
1940|211|R|and should not be refrigerated. Throw away all insulin products||
1940|212|R|after the expiration date on the package, or after the specified||
1940|213|R|number of days after it has been opened or kept at room||
1940|214|R|temperature, whichever date is earlier. Do not freeze and do not||
1940|215|R|use insulin that has been frozen.||
1940|216|R|   Different brands of the cartridges have different storage||
1940|217|R|needs. Check the product package for instructions on how to store||
1940|218|R|your brand, or ask your pharmacist.||
1940|219|R|   Protect insulin from light and heat. Do not store in the||
1940|220|R|bathroom. Keep all medications away from children and pets.||
1940|221|R|   Do not flush medications down the toilet or pour them into a||
1940|222|R|drain unless instructed to do so. Properly discard this product||
1940|223|R|when it is expired or no longer needed. Consult your pharmacist||
1940|224|R|or local waste disposal company.||
1940|225|B|||
1940|226|M|MEDICAL ALERT:  Your condition can cause complications in a||
1940|227|M|medical emergency. For information about enrolling in MedicAlert,||
1940|228|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1940|229|B|||
1940|230|A|Information last revised May 2025.||
1940|231|A|Copyright(c) 2025 First Databank, Inc.||
1940|232|B|||
1941|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1941|002|Z|does NOT have all possible information about this product. This||
1941|003|Z|information does not assure that this product is safe, effective,||
1941|004|Z|or appropriate for you. This information is not individual||
1941|005|Z|medical advice and does not substitute for the advice of your||
1941|006|Z|health care professional. Always ask your health care||
1941|007|Z|professional for complete information about this product and your||
1941|008|Z|specific health needs.||
1941|009|B|||
1941|010|T|PLAZOMICIN - INJECTION||
1941|011|F|(PLA-zoe-MYE-sin)||
1941|012|B|||
1941|013|C|COMMON BRAND NAME(S): Zemdri||
1941|014|B|||
1941|015|W|WARNING:  This medication can cause serious kidney problems and||
1941|016|W|nerve damage, resulting in permanent hearing loss (including||
1941|017|W|deafness or decreased hearing) and balance problems. The risk is||
1941|018|W|increased if you are an older adult, already have kidney disease,||
1941|019|W|or if you are taking other drugs that can affect the kidneys or||
1941|020|W|nerves. Your risk is also increased if you have a family history||
1941|021|W|of hearing loss, or receive high doses, or with longer use of||
1941|022|W|this medication.||
1941|023|W|   Tell your doctor right away if you notice ringing/roaring||
1941|024|W|sounds in the ears, hearing loss, dizziness, or an unusual||
1941|025|W|decrease in the amount of your urine. These symptoms can occur||
1941|026|W|even after treatment has finished.||
1941|027|W|   Careful monitoring by your doctor may lessen the risk of these||
1941|028|W|side effects. Monitoring may include hearing, kidney, urine, and||
1941|029|W|drug blood level tests.||
1941|030|B|||
1941|031|U|USES:  This medication is used to treat a variety of bacterial||
1941|032|U|infections. Plazomicin belongs to a class of drugs known as||
1941|033|U|aminoglycoside antibiotics. It works by stopping the growth of||
1941|034|U|bacteria.||
1941|035|B|||
1941|036|H|HOW TO USE:  This medication is given by injection into a vein as||
1941|037|H|directed by your doctor, usually every 24 hours. The dosage is||
1941|038|H|based on your medical condition, weight, lab tests, and response||
1941|039|H|to treatment.||
1941|040|H|   If you are using this medication at home, learn all||
1941|041|H|preparation and usage instructions from your health care||
1941|042|H|professional. Before using, check this product for particles or||
1941|043|H|discoloration. If either is present, do not use the liquid. Learn||
1941|044|H|how to store and discard medical supplies safely.||
1941|045|H|   For the best effect, use this antibiotic at evenly spaced||
1941|046|H|times. To help you remember, use this medication at the same time||
1941|047|H|every day.||
1941|048|H|   Continue to use this medication until the full prescribed||
1941|049|H|amount is finished, even if symptoms disappear after a few days.||
1941|050|H|Stopping the medication too early may result in a return of the||
1941|051|H|infection.||
1941|052|H|   Tell your doctor if your condition lasts or gets worse.||
1941|053|B|||
1941|054|S|SIDE EFFECTS:  See also Warning section.||
1941|055|S|   Pain/irritation/redness at the injection site may rarely||
1941|056|S|occur. If any of these effects last or get worse, tell your||
1941|057|S|doctor or pharmacist promptly.||
1941|058|S|   Remember that this medication has been prescribed because your||
1941|059|S|doctor has judged that the benefit to you is greater than the||
1941|060|S|risk of side effects. Many people using this medication do not||
1941|061|S|have serious side effects.||
1941|062|S|   Tell your doctor right away if you have any serious side||
1941|063|S|effects, including: muscle weakness.||
1941|064|S|   This medication may rarely cause a severe intestinal condition||
1941|065|S|due to a bacteria called C. difficile. This condition may occur||
1941|066|S|during treatment or weeks to months after treatment has stopped.||
1941|067|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1941|068|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1941|069|S|stool.||
1941|070|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1941|071|S|products because they may make symptoms worse.||
1941|072|S|   Use of this medication for prolonged or repeated periods may||
1941|073|S|result in oral thrush or a new yeast infection. Contact your||
1941|074|S|doctor if you notice white patches in your mouth, a change in||
1941|075|S|vaginal discharge, or other new symptoms.||
1941|076|S|   A very serious allergic reaction to this drug is rare.||
1941|077|S|However, get medical help right away if you notice any symptoms||
1941|078|S|of a serious allergic reaction, including: rash, itching/swelling||
1941|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1941|080|S|breathing.||
1941|081|S|   This is not a complete list of possible side effects. If you||
1941|082|S|notice other effects not listed above, contact your doctor or||
1941|083|S|pharmacist.||
1941|084|S|   In the US -||
1941|085|S|   Call your doctor for medical advice about side effects. You||
1941|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1941|087|S|www.fda.gov/medwatch.||
1941|088|S|   In Canada - Call your doctor for medical advice about side||
1941|089|S|effects. You may report side effects to Health Canada at||
1941|090|S|1-866-234-2345.||
1941|091|B|||
1941|092|P|PRECAUTIONS:  Before using plazomicin, tell your doctor or||
1941|093|P|pharmacist if you are allergic to it; or to other aminoglycoside||
1941|094|P|antibiotics (such as gentamicin, tobramycin); or if you have any||
1941|095|P|other allergies. This product may contain inactive ingredients,||
1941|096|P|which can cause allergic reactions or other problems. Talk to||
1941|097|P|your pharmacist for more details.||
1941|098|P|   Before using this medication, tell your doctor or pharmacist||
1941|099|P|your medical history, especially of: hearing problems (including||
1941|100|P|deafness, decreased hearing), kidney problems, myasthenia gravis.||
1941|101|P|   Plazomicin may cause live bacterial vaccines (such as typhoid||
1941|102|P|vaccine) to not work well. Tell your health care professional||
1941|103|P|that you are using plazomicin before having any||
1941|104|P|immunizations/vaccinations.||
1941|105|P|   Before having surgery, tell your doctor or dentist about all||
1941|106|P|the products you use (including prescription drugs,||
1941|107|P|nonprescription drugs, and herbal products).||
1941|108|P|   Older adults may be more sensitive to the effects of this||
1941|109|P|drug, especially kidney damage.||
1941|110|P|   Tell your doctor if you are pregnant or plan to become||
1941|111|P|pregnant. You should not become pregnant while using plazomicin.||
1941|112|P|Plazomicin may harm an unborn baby. If you become pregnant, talk||
1941|113|P|to your doctor right away about the risks and benefits of this||
1941|114|P|medication.||
1941|115|P|   It is unknown if this drug passes into breast milk. Consult||
1941|116|P|your doctor before breastfeeding.||
1941|117|B|||
1941|118|I|DRUG INTERACTIONS:  See also Warning section.||
1941|119|I|   Drug interactions may change how your medications work or||
1941|120|I|increase your risk for serious side effects. This document does||
1941|121|I|not contain all possible drug interactions. Keep a list of all||
1941|122|I|the products you use (including prescription/nonprescription||
1941|123|I|drugs and herbal products) and share it with your doctor and||
1941|124|I|pharmacist. Do not start, stop, or change the dosage of any||
1941|125|I|medicines without your doctor's approval.||
1941|126|B|||
1941|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1941|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1941|129|O|poison control center right away. US residents can call||
1941|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1941|131|B|||
1941|132|N|NOTES:  Lab and/or medical tests (such as kidney function, levels||
1941|133|N|of drug in your blood) may be done while you are using this||
1941|134|N|medication. Keep all medical and lab appointments.||
1941|135|B|||
1941|136|D|MISSED DOSE:  It is important to get each dose of this medication||
1941|137|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1941|138|D|right away for a new dosing schedule. Do not double the dose to||
1941|139|D|catch up.||
1941|140|B|||
1941|141|R|STORAGE:  Consult the product instructions and your pharmacist||
1941|142|R|for storage details. Keep all medications away from children and||
1941|143|R|pets.||
1941|144|R|   Do not flush medications down the toilet or pour them into a||
1941|145|R|drain unless instructed to do so. Properly discard this product||
1941|146|R|when it is expired or no longer needed. Consult your pharmacist||
1941|147|R|or local waste disposal company.||
1941|148|B|||
1941|149|A|Information last revised December 2024.||
1941|150|A|Copyright(c) 2025 First Databank, Inc.||
1941|151|B|||
1942|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1942|002|Z|does NOT have all possible information about this product. This||
1942|003|Z|information does not assure that this product is safe, effective,||
1942|004|Z|or appropriate for you. This information is not individual||
1942|005|Z|medical advice and does not substitute for the advice of your||
1942|006|Z|health care professional. Always ask your health care||
1942|007|Z|professional for complete information about this product and your||
1942|008|Z|specific health needs.||
1942|009|B|||
1942|010|T|IVOSIDENIB - ORAL||
1942|011|F|(EYE-voe-SID-e-nib)||
1942|012|B|||
1942|013|C|COMMON BRAND NAME(S): Tibsovo||
1942|014|B|||
1942|015|W|WARNING:  Ivosidenib has rarely caused a serious (possibly fatal)||
1942|016|W|condition called differentiation syndrome in patients with acute||
1942|017|W|myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Get||
1942|018|W|medical help right away if you develop any signs of||
1942|019|W|differentiation syndrome, such as fever, cough, shortness of||
1942|020|W|breath, chest pain, rapid weight gain, or swelling of arms/legs.||
1942|021|B|||
1942|022|U|USES:  This medication is used to treat certain types of blood||
1942|023|U|cell cancer (acute myeloid leukemia-AML, myelodysplastic||
1942|024|U|syndromes-MDS). Ivosidenib works by helping your bone marrow grow||
1942|025|U|normal blood cells so you will need fewer blood transfusions.||
1942|026|U|Ivosidenib is also used to treat bile duct cancer. It works by||
1942|027|U|slowing the growth of cancer cells.||
1942|028|B|||
1942|029|H|HOW TO USE:  Read the Medication Guide provided by your||
1942|030|H|pharmacist before you start taking ivosidenib and each time you||
1942|031|H|get a refill. If you have any questions, ask your doctor or||
1942|032|H|pharmacist.||
1942|033|H|   Take this medication by mouth as directed by your doctor,||
1942|034|H|usually once daily. Swallow the tablets whole. Do not crush,||
1942|035|H|split, or chew the tablets. Some brands should be taken on an||
1942|036|H|empty stomach and some brands may be taken with or without food.||
1942|037|H|If you are taking this medication on an empty stomach, do not eat||
1942|038|H|anything for 2 hours before and 1 hour after taking this||
1942|039|H|medication. If you take this medication with food, do not take||
1942|040|H|this medication with a high-fat meal. If you have any questions,||
1942|041|H|ask your doctor or pharmacist about your brand.||
1942|042|H|   The dosage is based on your medical condition, response to||
1942|043|H|treatment, and other medications you may be taking. Be sure to||
1942|044|H|tell your doctor and pharmacist about all the products you use||
1942|045|H|(including prescription drugs, nonprescription drugs, and herbal||
1942|046|H|products).||
1942|047|H|   Take this medication regularly to get the most benefit from||
1942|048|H|it. To help you remember, take it at the same time each day.||
1942|049|H|   Do not increase your dose or use this drug more often or for||
1942|050|H|longer than prescribed. Your condition will not improve any||
1942|051|H|faster, and your risk of serious side effects will increase.||
1942|052|H|   If you vomit after taking a dose, do not take another dose.||
1942|053|H|Take your next dose at the regular time the next day. Do not||
1942|054|H|double the dose to catch up.||
1942|055|B|||
1942|056|S|SIDE EFFECTS:  See also Warning section.||
1942|057|S|   Diarrhea, nausea, vomiting, stomach/abdominal pain,||
1942|058|S|constipation, mouth sores, decreased appetite, dizziness,||
1942|059|S|lightheadedness, headache, or tiredness may occur. If any of||
1942|060|S|these effects last or get worse, tell your doctor or pharmacist||
1942|061|S|promptly.||
1942|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
1942|063|S|slowly when rising from a sitting or lying position.||
1942|064|S|   Remember that this medication has been prescribed because your||
1942|065|S|doctor has judged that the benefit to you is greater than the||
1942|066|S|risk of side effects. Many people using this medication do not||
1942|067|S|have serious side effects.||
1942|068|S|   Tell your doctor right away if you have any serious side||
1942|069|S|effects, including: numb/tingling skin, muscle/joint pain.||
1942|070|S|   Get medical help right away if you have any very serious side||
1942|071|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1942|072|S|fainting, signs of kidney problems (such as painful urination,||
1942|073|S|pink/bloody urine, change in the amount of urine).||
1942|074|S|   Ivosidenib sometimes causes side effects due to the rapid||
1942|075|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1942|076|S|risk, your doctor may add a medication and tell you to drink||
1942|077|S|plenty of fluids. Tell your doctor right away if you have||
1942|078|S|symptoms such as: low back/side pain (flank pain), muscle||
1942|079|S|spasms/weakness.||
1942|080|S|   Ivosidenib can commonly cause a rash that is usually not||
1942|081|S|serious. However, you may not be able to tell it apart from a||
1942|082|S|rare rash that could be a sign of a severe reaction. Get medical||
1942|083|S|help right away if you develop any rash.||
1942|084|S|   A very serious allergic reaction to this drug is rare.||
1942|085|S|However, get medical help right away if you notice any symptoms||
1942|086|S|of a serious allergic reaction, including: rash, itching/swelling||
1942|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1942|088|S|breathing.||
1942|089|S|   This is not a complete list of possible side effects. If you||
1942|090|S|notice other effects not listed above, contact your doctor or||
1942|091|S|pharmacist.||
1942|092|S|   In the US -||
1942|093|S|   Call your doctor for medical advice about side effects. You||
1942|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1942|095|S|www.fda.gov/medwatch.||
1942|096|S|   In Canada - Call your doctor for medical advice about side||
1942|097|S|effects. You may report side effects to Health Canada at||
1942|098|S|1-866-234-2345.||
1942|099|B|||
1942|100|P|PRECAUTIONS:  Before taking ivosidenib, tell your doctor or||
1942|101|P|pharmacist if you are allergic to it; or if you have any other||
1942|102|P|allergies. This product may contain inactive ingredients, which||
1942|103|P|can cause allergic reactions or other problems. Talk to your||
1942|104|P|pharmacist for more details.||
1942|105|P|   Before using this medication, tell your doctor or pharmacist||
1942|106|P|your medical history.||
1942|107|P|   Ivosidenib may cause a condition that affects the heart rhythm||
1942|108|P|(QT prolongation). QT prolongation can rarely cause serious||
1942|109|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1942|110|P|as severe dizziness, fainting) that need medical attention right||
1942|111|P|away.||
1942|112|P|   The risk of QT prolongation may be increased if you have||
1942|113|P|certain medical conditions or are taking other drugs that may||
1942|114|P|cause QT prolongation. Before using ivosidenib, tell your doctor||
1942|115|P|or pharmacist of all the drugs you take and if you have any of||
1942|116|P|the following conditions: certain heart problems (heart failure,||
1942|117|P|slow heartbeat, QT prolongation in the EKG), family history of||
1942|118|P|certain heart problems (QT prolongation in the EKG, sudden||
1942|119|P|cardiac death).||
1942|120|P|   Low levels of potassium or magnesium in the blood may also||
1942|121|P|increase your risk of QT prolongation. This risk may increase if||
1942|122|P|you use certain drugs (such as diuretics/"water pills") or if you||
1942|123|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1942|124|P|Talk to your doctor about using ivosidenib safely.||
1942|125|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1942|126|P|can make you more dizzy. Do not drive, use machinery, or do||
1942|127|P|anything that needs alertness until you can do it safely. Limit||
1942|128|P|alcoholic beverages. Talk to your doctor if you are using||
1942|129|P|marijuana (cannabis).||
1942|130|P|   Before having surgery, tell your doctor or dentist about all||
1942|131|P|the products you use (including prescription drugs,||
1942|132|P|nonprescription drugs, and herbal products).||
1942|133|P|   Older adults may be more sensitive to the side effects of this||
1942|134|P|drug, especially QT prolongation (see above).||
1942|135|P|   Tell your doctor if you are pregnant or plan to become||
1942|136|P|pregnant. You should not become pregnant while using ivosidenib.||
1942|137|P|Ivosidenib may harm an unborn baby. Ask about reliable forms of||
1942|138|P|birth control while using this medication and for some time after||
1942|139|P|the last dose. If you become pregnant, talk to your doctor right||
1942|140|P|away about the risks and benefits of this medication.||
1942|141|P|   It is unknown if this medication passes into breast milk.||
1942|142|P|Because of the possible risk to the infant, breastfeeding is not||
1942|143|P|recommended while using this medication and for 1 month after the||
1942|144|P|last dose. Consult your doctor before breastfeeding.||
1942|145|B|||
1942|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1942|147|I|medications work or increase your risk for serious side effects.||
1942|148|I|This document does not contain all possible drug interactions.||
1942|149|I|Keep a list of all the products you use (including||
1942|150|I|prescription/nonprescription drugs and herbal products) and share||
1942|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
1942|152|I|the dosage of any medicines without your doctor's approval.||
1942|153|I|   Other medications can affect the removal of ivosidenib from||
1942|154|I|your body, which may affect how ivosidenib works. Examples||
1942|155|I|include rifamycins (such as rifabutin), St. John's wort, drugs||
1942|156|I|used to treat seizures (such as carbamazepine, phenytoin), among||
1942|157|I|others.||
1942|158|I|   This medication can speed up the removal of other medications||
1942|159|I|from your body, which may affect how they work. Examples of||
1942|160|I|affected drugs include artemether/lumefantrine, daridorexant,||
1942|161|I|fostemsavir, certain HIV protease inhibitors (such as||
1942|162|I|atazanavir), itraconazole, ketoconazole, lonafarnib, mavacamten,||
1942|163|I|nimodipine, rilpivirine, ticagrelor, among others.||
1942|164|I|   This medication may decrease the effectiveness of hormonal||
1942|165|I|birth control such as pills, patch, or ring. This could cause||
1942|166|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1942|167|I|use reliable backup birth control methods while using this||
1942|168|I|medication. Also tell your doctor if you have any new spotting or||
1942|169|I|breakthrough bleeding, because these may be signs that your birth||
1942|170|I|control is not working well.||
1942|171|I|   Many drugs besides ivosidenib may affect the heart rhythm (QT||
1942|172|I|prolongation), including pacritinib, among others.||
1942|173|B|||
1942|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1942|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1942|176|O|poison control center right away. US residents can call||
1942|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1942|178|B|||
1942|179|N|NOTES:  Do not share this medication with others.||
1942|180|N|   Lab tests (such as complete blood counts, blood mineral||
1942|181|N|levels, ECG, liver/kidney function) should be done before you||
1942|182|N|start taking this medication and while you are taking it. Keep||
1942|183|N|all medical and lab appointments.||
1942|184|B|||
1942|185|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1942|186|D|remember. If it is within 12 hours of the next dose, skip the||
1942|187|D|missed dose. Take your next dose at the regular time. Do not||
1942|188|D|double the dose to catch up.||
1942|189|B|||
1942|190|R|STORAGE:  Store at room temperature away from light and moisture.||
1942|191|R|Do not store in the bathroom. Keep the drying agent (desiccant)||
1942|192|R|in the bottle. Tightly close the bottle when not in use. Keep all||
1942|193|R|medications away from children and pets.||
1942|194|R|   Do not flush medications down the toilet or pour them into a||
1942|195|R|drain unless instructed to do so. Properly discard this product||
1942|196|R|when it is expired or no longer needed. Consult your pharmacist||
1942|197|R|or local waste disposal company.||
1942|198|B|||
1942|199|A|Information last revised March 2025.||
1942|200|A|Copyright(c) 2025 First Databank, Inc.||
1942|201|B|||
1943|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1943|002|Z|does NOT have all possible information about this product. This||
1943|003|Z|information does not assure that this product is safe, effective,||
1943|004|Z|or appropriate for you. This information is not individual||
1943|005|Z|medical advice and does not substitute for the advice of your||
1943|006|Z|health care professional. Always ask your health care||
1943|007|Z|professional for complete information about this product and your||
1943|008|Z|specific health needs.||
1943|009|B|||
1943|010|T|DARUNAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL||
1943|011|F|(dar-UE-na-vir/koe-BIK-i-stat/EM-trye-SYE-ta-been/||
1943|012|F|ten-OF-oh-vir AL-a-FEN-a-mide)||
1943|013|B|||
1943|014|C|COMMON BRAND NAME(S): Symtuza||
1943|015|B|||
1943|016|W|WARNING:  If you have hepatitis B infection, your hepatitis||
1943|017|W|symptoms may get worse or become very serious if you stop taking||
1943|018|W|this medication. Talk with your doctor before stopping this||
1943|019|W|medication. Your doctor will monitor liver tests for several||
1943|020|W|months after you stop||
1943|021|W|darunavir/cobicistat/emtricitabine/tenofovir alafenamide. Tell||
1943|022|W|your doctor right away if you have symptoms of worsening liver||
1943|023|W|problems.||
1943|024|B|||
1943|025|U|USES:  This product is used to help control HIV infection. It||
1943|026|U|helps to decrease the amount of HIV in your body so your immune||
1943|027|U|system can work better. This lowers your chance of getting HIV||
1943|028|U|complications (such as new infections, cancer) and improves your||
1943|029|U|quality of life. This product contains 4 different medications:||
1943|030|U|darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.||
1943|031|U|Darunavir is known as a protease inhibitor. Cobicistat helps||
1943|032|U|darunavir work better. Emtricitabine is called a nucleoside||
1943|033|U|reverse transcriptase inhibitor, while tenofovir alafenamide is||
1943|034|U|called a nucleotide reverse transcriptase inhibitor; both kinds||
1943|035|U|of drugs are often called NRTIs.||
1943|036|U|   Darunavir/cobicistat/emtricitabine/tenofovir alafenamide is||
1943|037|U|not a cure for HIV infection. To decrease your risk of spreading||
1943|038|U|HIV disease to others, continue to take all HIV medications||
1943|039|U|exactly as prescribed by your doctor. Use an effective barrier||
1943|040|U|method (latex or polyurethane condoms/dental dams) during sexual||
1943|041|U|activity as directed by your doctor. Do not share personal items||
1943|042|U|(such as needles/syringes, toothbrushes, and razors) that may||
1943|043|U|have contacted blood or other body fluids. Consult your doctor or||
1943|044|U|pharmacist for more details.||
1943|045|B|||
1943|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1943|047|H|from your pharmacist before you start taking this medication and||
1943|048|H|each time you get a refill. If you have any questions, ask your||
1943|049|H|doctor or pharmacist.||
1943|050|H|   Take this medication by mouth with food as directed by your||
1943|051|H|doctor, usually once daily. If you have trouble swallowing this||
1943|052|H|medication whole, you may split the tablet with a tablet cutter||
1943|053|H|before taking it. Take each part of the split tablet right away.||
1943|054|H|   It is very important to keep taking this medication exactly as||
1943|055|H|prescribed by your doctor. Do not skip any doses.||
1943|056|H|   For the best effect, take this medication at evenly spaced||
1943|057|H|times. To help you remember, take this medication at the same||
1943|058|H|time every day.||
1943|059|H|   Do not take more or less of this drug than prescribed or stop||
1943|060|H|taking it even for a short time unless directed to do so by your||
1943|061|H|doctor. Doing so may cause the amount of virus to increase, make||
1943|062|H|the infection more difficult to treat (resistant), or worsen side||
1943|063|H|effects.||
1943|064|B|||
1943|065|S|SIDE EFFECTS:  Diarrhea, nausea, headache, or tiredness may||
1943|066|S|occur. If any of these effects last or get worse, tell your||
1943|067|S|doctor or pharmacist promptly.||
1943|068|S|   Remember that this medication has been prescribed because your||
1943|069|S|doctor has judged that the benefit to you is greater than the||
1943|070|S|risk of side effects. Many people using this medication do not||
1943|071|S|have serious side effects.||
1943|072|S|   As your immune system gets stronger, it can begin to fight off||
1943|073|S|infections you already had, possibly causing disease symptoms to||
1943|074|S|come back. You could also have symptoms if your immune system||
1943|075|S|becomes overactive. This reaction may happen at any time (soon||
1943|076|S|after starting HIV treatment or many months later). Tell your||
1943|077|S|doctor right away if you have any serious symptoms, including:||
1943|078|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1943|079|S|that doesn't go away, headaches that are severe or don't go away,||
1943|080|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1943|081|S|changes, signs of infection (such as sore throat that doesn't go||
1943|082|S|away, fever, chills, non-healing skin sores), signs of an||
1943|083|S|overactive thyroid (such as irritability, nervousness, heat||
1943|084|S|intolerance, fast/pounding/irregular heartbeat).||
1943|085|S|   Tell your doctor right away if you have any serious side||
1943|086|S|effects, including: signs of kidney problems (such as change in||
1943|087|S|the amount of urine, pink/bloody urine), easy bruising/bleeding.||
1943|088|S|   Rarely, this medication can cause severe (sometimes fatal)||
1943|089|S|liver and blood problems (lactic acidosis). Tell your doctor||
1943|090|S|right away if you develop symptoms of liver problems (such as||
1943|091|S|nausea/vomiting that doesn't stop, loss of appetite,||
1943|092|S|stomach/abdominal pain, yellowing eyes/skin, dark urine) or||
1943|093|S|lactic acidosis (such as deep/rapid breathing, drowsiness,||
1943|094|S|nausea/vomiting, unusual weakness).||
1943|095|S|   This medication may rarely make your blood sugar rise, which||
1943|096|S|can cause or worsen diabetes. Tell your doctor right away if you||
1943|097|S|have symptoms of high blood sugar such as increased||
1943|098|S|thirst/urination. If you already have diabetes, check your blood||
1943|099|S|sugar regularly as directed and share the results with your||
1943|100|S|doctor. Your doctor may need to adjust your diabetes medication,||
1943|101|S|exercise program, or diet.||
1943|102|S|   Changes in body fat may occur while you are taking this||
1943|103|S|medication (such as increased fat in the upper back and stomach||
1943|104|S|areas, decreased fat in the arms and legs). The cause and||
1943|105|S|long-term effects of these changes are unknown. Discuss the risks||
1943|106|S|and benefits of treatment with your doctor, as well as the||
1943|107|S|possible use of exercise to reduce this side effect.||
1943|108|S|   This medication can commonly cause a rash that is usually not||
1943|109|S|serious. However, you may not be able to tell it apart from a||
1943|110|S|rare rash that could be a sign of a severe reaction. Get medical||
1943|111|S|help right away if you develop any rash, especially with symptoms||
1943|112|S|such as fever, tiredness, muscle/joint pain, blisters, mouth||
1943|113|S|sores, or red/swollen eyes.||
1943|114|S|   A very serious allergic reaction to this drug is rare.||
1943|115|S|However, get medical help right away if you notice any symptoms||
1943|116|S|of a serious allergic reaction, including: swollen lymph nodes,||
1943|117|S|rash, itching/swelling (especially of the face/tongue/throat),||
1943|118|S|severe dizziness, trouble breathing.||
1943|119|S|   This is not a complete list of possible side effects. If you||
1943|120|S|notice other effects not listed above, contact your doctor or||
1943|121|S|pharmacist.||
1943|122|S|   In the US -||
1943|123|S|   Call your doctor for medical advice about side effects. You||
1943|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1943|125|S|www.fda.gov/medwatch.||
1943|126|S|   In Canada - Call your doctor for medical advice about side||
1943|127|S|effects. You may report side effects to Health Canada at||
1943|128|S|1-866-234-2345.||
1943|129|B|||
1943|130|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
1943|131|P|pharmacist if you are allergic to darunavir, cobicistat,||
1943|132|P|emtricitabine, or tenofovir; or if you have any other allergies.||
1943|133|P|This product may contain inactive ingredients, which can cause||
1943|134|P|allergic reactions or other problems. Talk to your pharmacist for||
1943|135|P|more details.||
1943|136|P|   Before using this medication, tell your doctor or pharmacist||
1943|137|P|your medical history, especially of: liver problems (hepatitis B,||
1943|138|P|hepatitis C, cirrhosis), a certain bleeding problem (hemophilia),||
1943|139|P|kidney problems.||
1943|140|P|   Before having surgery, tell your doctor or dentist about all||
1943|141|P|the products you use (including prescription drugs,||
1943|142|P|nonprescription drugs, and herbal products).||
1943|143|P|   This medication is not recommended for use during pregnancy.||
1943|144|P|It may not work well in a pregnant woman. If you become pregnant||
1943|145|P|or think you may be pregnant, tell your doctor right away. Your||
1943|146|P|doctor may change your HIV medications.||
1943|147|P|   Emtricitabine, darunavir, and tenofovir alafenamide pass into||
1943|148|P|breast milk. It is unknown if cobicistat passes into breast milk.||
1943|149|P|Because breast milk may transmit HIV, consult your doctor before||
1943|150|P|breastfeeding.||
1943|151|B|||
1943|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1943|153|I|medications work or increase your risk for serious side effects.||
1943|154|I|This document does not contain all possible drug interactions.||
1943|155|I|Keep a list of all the products you use (including||
1943|156|I|prescription/nonprescription drugs and herbal products) and share||
1943|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
1943|158|I|the dosage of any medicines without your doctor's approval.||
1943|159|I|   Some products that may interact with this drug are: adefovir,||
1943|160|I|orlistat.||
1943|161|I|   Do not take this medication with other HIV medications (such||
1943|162|I|as ritonavir). Do not take this medication with other products||
1943|163|I|that contain cobicistat, darunavir, emtricitabine, or tenofovir.||
1943|164|I|   This medication can slow down the removal of other medications||
1943|165|I|from your body, which may affect how they work. Examples of||
1943|166|I|affected drugs include dronedarone, eletriptan, eplerenone, ergot||
1943|167|I|alkaloids (such as ergotamine, dihydroergotamine), lomitapide,||
1943|168|I|pimozide, ranolazine, rivaroxaban, salmeterol, tolvaptan, certain||
1943|169|I|alpha blockers (such as alfuzosin, tamsulosin), certain||
1943|170|I|benzodiazepines (such as midazolam, triazolam), certain statins||
1943|171|I|(such as lovastatin, simvastatin), certain drugs to treat||
1943|172|I|erectile dysfunction-ED or pulmonary hypertension (such as||
1943|173|I|avanafil, sildenafil), among others.||
1943|174|I|   Other medications can affect the removal of this medication||
1943|175|I|from your body, which may affect how this medication works.||
1943|176|I|Examples include apalutamide, mitotane, certain rifamycins (such||
1943|177|I|as rifampin, rifapentine), St. John's wort, certain drugs used to||
1943|178|I|treat seizures (such as carbamazepine, oxcarbazepine,||
1943|179|I|phenobarbital, phenytoin, primidone), among others.||
1943|180|I|   This medication may decrease the effectiveness of hormonal||
1943|181|I|birth control such as pills, patch, or ring. This could cause||
1943|182|I|pregnancy. This medication may also increase the risk of some||
1943|183|I|hormonal birth control side effects. Talk to your doctor about||
1943|184|I|other reliable forms of birth control, and use an effective||
1943|185|I|barrier method (latex or polyurethane condoms/dental dams) during||
1943|186|I|sexual activity to decrease the risk of spreading HIV to others.||
1943|187|I|Tell your doctor if you have any new spotting or breakthrough||
1943|188|I|bleeding, because these may be signs that your hormonal birth||
1943|189|I|control is not working well.||
1943|190|B|||
1943|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1943|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1943|193|O|poison control center right away. US residents can call||
1943|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1943|195|B|||
1943|196|N|NOTES:  Do not share this medication with others.||
1943|197|N|   Lab and/or medical tests (such as kidney/liver function, test||
1943|198|N|for hepatitis B virus, viral load, T-cell counts, blood mineral||
1943|199|N|levels, bone density tests, urine glucose/protein) should be done||
1943|200|N|before you start taking this medication and while you are taking||
1943|201|N|it. Keep all medical and lab appointments. Consult your doctor||
1943|202|N|for more details.||
1943|203|B|||
1943|204|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1943|205|D|remember. If it is near the time of the next dose, skip the||
1943|206|D|missed dose. Take your next dose at the regular time. Do not||
1943|207|D|double the dose to catch up.||
1943|208|B|||
1943|209|R|STORAGE:  Store in the original container at room temperature||
1943|210|R|away from light and moisture. Do not store in the bathroom. Keep||
1943|211|R|all medications away from children and pets.||
1943|212|R|   Do not flush medications down the toilet or pour them into a||
1943|213|R|drain unless instructed to do so. Properly discard this product||
1943|214|R|when it is expired or no longer needed. Consult your pharmacist||
1943|215|R|or local waste disposal company.||
1943|216|B|||
1943|217|A|Information last revised April 2025.||
1943|218|A|Copyright(c) 2025 First Databank, Inc.||
1943|219|B|||
1944|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1944|002|Z|does NOT have all possible information about this product. This||
1944|003|Z|information does not assure that this product is safe, effective,||
1944|004|Z|or appropriate for you. This information is not individual||
1944|005|Z|medical advice and does not substitute for the advice of your||
1944|006|Z|health care professional. Always ask your health care||
1944|007|Z|professional for complete information about this product and your||
1944|008|Z|specific health needs.||
1944|009|B|||
1944|010|T|FOLLITROPIN DELTA - INJECTION||
1944|011|F|(FOL-i-TROE-pin DEL-ta)||
1944|012|B|||
1944|013|U|USES:  This medication contains follicle-stimulating hormone||
1944|014|U|(FSH), a hormone that your body normally makes. It is used in||
1944|015|U|assisted reproduction programs to treat certain fertility||
1944|016|U|problems. Follitropin delta works by helping healthy ovaries to||
1944|017|U|produce eggs. This medication is usually used in combination with||
1944|018|U|another hormone (hCG) to cause the growth and release of mature||
1944|019|U|eggs (ovulation). The eggs are then collected and fertilized in||
1944|020|U|the lab. Talk with your doctor about the risks and benefits of||
1944|021|U|using this medication, including multiple births, birth defects,||
1944|022|U|and miscarriage.||
1944|023|U|   This medication is not recommended for women whose ovaries no||
1944|024|U|longer make eggs properly (primary ovarian failure).||
1944|025|B|||
1944|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1944|027|H|from your pharmacist before you start using follitropin delta and||
1944|028|H|each time you get a refill. Ask your health care professional how||
1944|029|H|to prepare and use this medication. If you have any questions,||
1944|030|H|ask your doctor or pharmacist.||
1944|031|H|   This medication is injected under the skin as directed by your||
1944|032|H|doctor, usually once a day. The injection is given in the||
1944|033|H|abdomen. Your doctor may direct you to use this medication in a||
1944|034|H|treatment cycle (for example, only on certain days each month).||
1944|035|H|The dosage is based on your medical condition, response to||
1944|036|H|treatment, and labs.||
1944|037|H|   Before using, check this product for particles or||
1944|038|H|discoloration. If either is present, do not use the liquid.||
1944|039|H|Before injecting each dose, clean the skin you are going to||
1944|040|H|inject into (the injection site) with rubbing alcohol. Change the||
1944|041|H|injection site each time to lessen injury under the skin. To||
1944|042|H|lessen bruising, do not rub the injection site after a shot.||
1944|043|H|Learn how to store and discard medical supplies safely.||
1944|044|H|   Use this medication exactly as directed by your doctor to get||
1944|045|H|the most benefit from it. Do not increase your dose or use this||
1944|046|H|drug more often or for longer than prescribed.||
1944|047|B|||
1944|048|S|SIDE EFFECTS:  Redness/pain at the injection site, headache,||
1944|049|S|pelvic discomfort/pain, or tiredness may occur. If any of these||
1944|050|S|effects last or get worse, tell your doctor or pharmacist||
1944|051|S|promptly.||
1944|052|S|   Remember that this medication has been prescribed because your||
1944|053|S|doctor has judged that the benefit to you is greater than the||
1944|054|S|risk of side effects. Many people using this medication do not||
1944|055|S|have serious side effects.||
1944|056|S|   Tell your doctor right away if you have any serious side||
1944|057|S|effects, including: bleeding from the vagina/uterus.||
1944|058|S|   This medication may rarely cause serious problems from blood||
1944|059|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1944|060|S|legs). You may be at increased risk for blood clots if you have a||
1944|061|S|history of blood clots, or if you are immobile (such as on very||
1944|062|S|long plane flights or being bedridden). Before using this||
1944|063|S|medication, if you have any of these conditions report them to||
1944|064|S|your doctor or pharmacist. Get medical help right away if any of||
1944|065|S|these side effects occur: shortness of breath/rapid breathing,||
1944|066|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1944|067|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1944|068|S|sudden/severe headaches, trouble speaking, weakness on one side||
1944|069|S|of the body, sudden vision changes.||
1944|070|S|   This medication may cause a condition known as ovarian||
1944|071|S|hyperstimulation syndrome (OHSS). This condition may occur during||
1944|072|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
1944|073|S|build up in the stomach, chest, and heart area. Get medical help||
1944|074|S|right away if you develop the following side effects: severe pain||
1944|075|S|or swelling in the lower abdominal (pelvic) area, severe||
1944|076|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
1944|077|S|urination.||
1944|078|S|   A very serious allergic reaction to this drug is rare.||
1944|079|S|However, get medical help right away if you notice any symptoms||
1944|080|S|of a serious allergic reaction, including: rash, itching/swelling||
1944|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1944|082|S|breathing.||
1944|083|S|   This is not a complete list of possible side effects. If you||
1944|084|S|notice other effects not listed above, contact your doctor or||
1944|085|S|pharmacist.||
1944|086|S|   In the US -||
1944|087|S|   Call your doctor for medical advice about side effects. You||
1944|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1944|089|S|www.fda.gov/medwatch.||
1944|090|S|   In Canada - Call your doctor for medical advice about side||
1944|091|S|effects. You may report side effects to Health Canada at||
1944|092|S|1-866-234-2345.||
1944|093|B|||
1944|094|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
1944|095|P|pharmacist if you are allergic to it; or to other products||
1944|096|P|containing follicle-stimulating hormone (FSH); or if you have any||
1944|097|P|other allergies. This product may contain inactive ingredients,||
1944|098|P|which can cause allergic reactions or other problems. Talk to||
1944|099|P|your pharmacist for more details.||
1944|100|P|   Before using this medication, tell your doctor or pharmacist||
1944|101|P|your medical history, especially of: other fertility problems||
1944|102|P|(such as primary ovarian failure, early menopause), abnormal||
1944|103|P|bleeding from the vagina/uterus, thyroid problems, adrenal gland||
1944|104|P|problems, cancer of the reproductive organs (such as breast,||
1944|105|P|uterus, ovary), tumor in the brain (such as pituitary tumor),||
1944|106|P|ovarian cysts or enlarged ovaries, blood clots.||
1944|107|P|   Before having surgery, tell your doctor or dentist about all||
1944|108|P|the products you use (including prescription drugs,||
1944|109|P|nonprescription drugs, and herbal products).||
1944|110|P|   Multiple births may occur as a result of this treatment.||
1944|111|P|Consult your doctor for more details.||
1944|112|P|   Stop using this medication if you become pregnant. This||
1944|113|P|medication must not be used during pregnancy. If you think you||
1944|114|P|may be pregnant, tell your doctor right away.||
1944|115|P|   It is unknown if this drug passes into breast milk. Consult||
1944|116|P|your doctor before breastfeeding.||
1944|117|B|||
1944|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1944|119|I|medications work or increase your risk for serious side effects.||
1944|120|I|This document does not contain all possible drug interactions.||
1944|121|I|Keep a list of all the products you use (including||
1944|122|I|prescription/nonprescription drugs and herbal products) and share||
1944|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
1944|124|I|the dosage of any medicines without your doctor's approval.||
1944|125|I|   A product that may interact with this drug is: gonadorelin.||
1944|126|B|||
1944|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1944|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1944|129|O|poison control center right away. US residents can call||
1944|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1944|131|B|||
1944|132|N|NOTES:  Do not share this medication with others.||
1944|133|N|   Lab and/or medical tests (such as vaginal ultrasound, hormone||
1944|134|N|levels, liver tests) may be done while you are using this||
1944|135|N|medication. Keep all medical and lab appointments. Consult your||
1944|136|N|doctor for more details.||
1944|137|B|||
1944|138|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
1944|139|D|right away for a new dosing schedule. Do not double the dose to||
1944|140|D|catch up.||
1944|141|B|||
1944|142|R|STORAGE:  Store the unused pen in the refrigerator. Do not||
1944|143|R|freeze. Keep the product in the original packaging to protect||
1944|144|R|from light. The unused pen may also be stored at room temperature||
1944|145|R|if needed. If the unused pen is stored at room temperature,||
1944|146|R|discard after 3 months. Once used, this product may be stored in||
1944|147|R|the refrigerator or at room temperature away from light. Discard||
1944|148|R|the used pen after 28 days. Keep all medications away from||
1944|149|R|children and pets.||
1944|150|R|   Do not flush medications down the toilet or pour them into a||
1944|151|R|drain unless instructed to do so. Properly discard this product||
1944|152|R|when it is expired or no longer needed. Consult your pharmacist||
1944|153|R|or local waste disposal company.||
1944|154|B|||
1944|155|A|Information last revised September 2024.||
1944|156|A|Copyright(c) 2025 First Databank, Inc.||
1944|157|B|||
1945|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1945|002|Z|does NOT have all possible information about this product. This||
1945|003|Z|information does not assure that this product is safe, effective,||
1945|004|Z|or appropriate for you. This information is not individual||
1945|005|Z|medical advice and does not substitute for the advice of your||
1945|006|Z|health care professional. Always ask your health care||
1945|007|Z|professional for complete information about this product and your||
1945|008|Z|specific health needs.||
1945|009|B|||
1945|010|T|ELAGOLIX - ORAL||
1945|011|F|(EL-a-GOE-lix)||
1945|012|B|||
1945|013|C|COMMON BRAND NAME(S): Orilissa||
1945|014|B|||
1945|015|U|USES:  This medication is used by women to help relieve moderate||
1945|016|U|to severe pain due to a condition called endometriosis.||
1945|017|U|Endometriosis is the growth of tissue that normally lines the||
1945|018|U|inside of the womb (uterus) in a different place, such as on the||
1945|019|U|outside surface of the uterus, on the ovaries, or on other||
1945|020|U|organs. This condition may cause symptoms such as||
1945|021|U|painful/heavy/irregular menstrual periods, pain during or after||
1945|022|U|sex, or infertility. Elagolix works by decreasing your body's||
1945|023|U|production of certain hormones (luteinizing hormone,||
1945|024|U|follicle-stimulating hormone), which leads to lower amounts of||
1945|025|U|female sex hormones (estrogens). These lower levels may help||
1945|026|U|decrease some symptoms of endometriosis.||
1945|027|B|||
1945|028|H|HOW TO USE:  Read the Medication Guide provided by your||
1945|029|H|pharmacist before you start taking elagolix and each time you get||
1945|030|H|a refill. If you have any questions, ask your doctor or||
1945|031|H|pharmacist.||
1945|032|H|   To make sure you are not pregnant, your doctor may do a||
1945|033|H|pregnancy test before you start taking this medication, or tell||
1945|034|H|you to start taking it within 7 days after the start of your||
1945|035|H|menstrual period. Start taking this medication only when directed||
1945|036|H|by your doctor.||
1945|037|H|   Take this medication by mouth with or without food as directed||
1945|038|H|by your doctor, usually once or twice daily. The dosage and||
1945|039|H|length of treatment are based on your medical condition, response||
1945|040|H|to treatment, and other drugs you may be taking. Be sure to tell||
1945|041|H|your doctor and pharmacist about all the products you use||
1945|042|H|(including prescription drugs, nonprescription drugs, and herbal||
1945|043|H|products). To lessen the risk of bone loss, this medication is||
1945|044|H|usually taken for up to 6 months or up to 24 months. Talk with||
1945|045|H|your doctor for details.||
1945|046|H|   Use this medication regularly to get the most benefit from it.||
1945|047|H|To help you remember, take it at the same time(s) each day.||
1945|048|H|   Tell your doctor if your condition does not get better or if||
1945|049|H|it gets worse.||
1945|050|B|||
1945|051|S|SIDE EFFECTS:  Nausea, trouble sleeping, hot flashes, night||
1945|052|S|sweats, headache, or menstrual period changes may occur. If any||
1945|053|S|of these effects last or get worse, tell your doctor or||
1945|054|S|pharmacist promptly.||
1945|055|S|   Remember that this medication has been prescribed because your||
1945|056|S|doctor has judged that the benefit to you is greater than the||
1945|057|S|risk of side effects. Many people using this medication do not||
1945|058|S|have serious side effects.||
1945|059|S|   Tell your doctor right away if you have any serious side||
1945|060|S|effects, including: mental/mood changes (such as new or worsening||
1945|061|S|depression, anxiety, unusual changes in behavior), signs of liver||
1945|062|S|damage (such as nausea/vomiting that doesn't stop, loss of||
1945|063|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1945|064|S|urine).||
1945|065|S|   Get medical help right away if you have any very serious side||
1945|066|S|effects, including: thoughts of suicide.||
1945|067|S|   This medication lowers estrogen levels in your body. Low||
1945|068|S|estrogen levels can lead to bone loss. The risk is increased with||
1945|069|S|higher doses or with longer use of this medication. Some bone||
1945|070|S|loss may be permanent, so you should take this medication at the||
1945|071|S|lowest effective dose. Talk with your doctor about the risks and||
1945|072|S|benefits of taking this medication, and ask about taking calcium||
1945|073|S|supplements and vitamin D for bone health.||
1945|074|S|   A very serious allergic reaction to this drug is rare.||
1945|075|S|However, get medical help right away if you notice any symptoms||
1945|076|S|of a serious allergic reaction, including: rash, itching/swelling||
1945|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1945|078|S|breathing.||
1945|079|S|   This is not a complete list of possible side effects. If you||
1945|080|S|notice other effects not listed above, contact your doctor or||
1945|081|S|pharmacist.||
1945|082|S|   In the US -||
1945|083|S|   Call your doctor for medical advice about side effects. You||
1945|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1945|085|S|www.fda.gov/medwatch.||
1945|086|S|   In Canada - Call your doctor for medical advice about side||
1945|087|S|effects. You may report side effects to Health Canada at||
1945|088|S|1-866-234-2345.||
1945|089|B|||
1945|090|P|PRECAUTIONS:  Before taking elagolix, tell your doctor or||
1945|091|P|pharmacist if you are allergic to it; or if you have any other||
1945|092|P|allergies. This product may contain inactive ingredients, which||
1945|093|P|can cause allergic reactions or other problems. Talk to your||
1945|094|P|pharmacist for more details.||
1945|095|P|   Before using this medication, tell your doctor or pharmacist||
1945|096|P|your medical history, especially of: liver problems, bone loss||
1945|097|P|(osteoporosis), mental/mood disorders (such as depression).||
1945|098|P|   Before having surgery, tell your doctor or dentist about all||
1945|099|P|the products you use (including prescription drugs,||
1945|100|P|nonprescription drugs, and herbal products).||
1945|101|P|   This medication must not be used during pregnancy. Elagolix||
1945|102|P|may harm an unborn baby. Ask about reliable forms of non-hormonal||
1945|103|P|birth control (such as condoms, spermicide) while using this||
1945|104|P|medication and for 4 weeks after stopping treatment. Because this||
1945|105|P|medication affects menstruation, it may be harder to tell if you||
1945|106|P|are pregnant. If you become pregnant or think you may be||
1945|107|P|pregnant, tell your doctor right away.||
1945|108|P|   It is unknown if this medication passes into breast milk.||
1945|109|P|Consult your doctor before breastfeeding.||
1945|110|B|||
1945|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1945|112|I|medications work or increase your risk for serious side effects.||
1945|113|I|This document does not contain all possible drug interactions.||
1945|114|I|Keep a list of all the products you use (including||
1945|115|I|prescription/nonprescription drugs and herbal products) and share||
1945|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1945|117|I|the dosage of any medicines without your doctor's approval.||
1945|118|I|   Other medications can affect the removal of elagolix from your||
1945|119|I|body, which may affect how elagolix works. Examples include||
1945|120|I|belumosudil, cyclosporine, encorafenib, gemfibrozil, letermovir,||
1945|121|I|resmetirom, vadadustat, voclosporin, among others.||
1945|122|I|   This medication can speed up the removal of other medications||
1945|123|I|from your body, which may affect how they work. Examples of||
1945|124|I|affected drugs include daridorexant, elacestrant, mavacamten,||
1945|125|I|quizartinib, revumenib, among others.||
1945|126|I|   Hormonal birth control may interact with this medication.||
1945|127|I|Women of childbearing age should talk with the doctor about using||
1945|128|I|reliable forms of non-hormonal birth control.||
1945|129|B|||
1945|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1945|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1945|132|O|poison control center right away. US residents can call||
1945|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1945|134|B|||
1945|135|N|NOTES:  Do not share this medication with others.||
1945|136|N|   Lab and/or medical tests (such as liver function, cholesterol,||
1945|137|N|pregnancy test, bone density tests) may be done before you start||
1945|138|N|taking this medication and while you are taking it. Keep all||
1945|139|N|medical and lab appointments.||
1945|140|B|||
1945|141|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
1945|142|D|if it is on the same day. If you do not remember until the next||
1945|143|D|day, skip the missed dose. Take your next dose at the regular||
1945|144|D|time. Do not double the dose to catch up.||
1945|145|B|||
1945|146|R|STORAGE:  Store in the refrigerator or at room temperature away||
1945|147|R|from light and moisture. Do not freeze. Do not store in the||
1945|148|R|bathroom. Keep all medications away from children and pets.||
1945|149|R|   Do not flush medications down the toilet or pour them into a||
1945|150|R|drain unless instructed to do so. Properly discard this product||
1945|151|R|when it is expired or no longer needed. Consult your pharmacist||
1945|152|R|or local waste disposal company.||
1945|153|B|||
1945|154|A|Information last revised October 2025.||
1945|155|A|Copyright(c) 2025 First Databank, Inc.||
1945|156|B|||
1946|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1946|002|Z|does NOT have all possible information about this product. This||
1946|003|Z|information does not assure that this product is safe, effective,||
1946|004|Z|or appropriate for you. This information is not individual||
1946|005|Z|medical advice and does not substitute for the advice of your||
1946|006|Z|health care professional. Always ask your health care||
1946|007|Z|professional for complete information about this product and your||
1946|008|Z|specific health needs.||
1946|009|B|||
1946|010|T|FUSIDIC ACID/BETAMETHASONE VALERATE - TOPICAL||
1946|011|F|(fue-SID-ik AS-id/BAY-ta-METH-a-sone VAL-er-ate)||
1946|012|B|||
1946|013|U|USES:  This product is a combination of 2 medications: fusidic||
1946|014|U|acid and betamethasone valerate. It is used to treat certain skin||
1946|015|U|conditions (types of eczema) when bacterial infection is also||
1946|016|U|present. Betamethasone is a medium-strength corticosteroid used||
1946|017|U|on the skin to reduce the swelling, itching, and redness that can||
1946|018|U|occur in these types of conditions. Fusidic acid is an antibiotic||
1946|019|U|that works by stopping the growth of certain bacteria. This||
1946|020|U|medication should be used short-term (up to 2 weeks) to treat||
1946|021|U|eczema with bacterial infection. Using any antibiotic when it is||
1946|022|U|not needed can cause it to not work for future infections.||
1946|023|B|||
1946|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1946|025|H|from your pharmacist before you start using this medication and||
1946|026|H|each time you get a refill. If you have any questions, ask your||
1946|027|H|doctor or pharmacist.||
1946|028|H|   This medication is for use on the skin only. However, do not||
1946|029|H|use it on the face, groin, or underarms unless directed to do so||
1946|030|H|by your doctor.||
1946|031|H|   Wash and dry your hands before applying the medication. Clean||
1946|032|H|and dry the affected area. Apply a thin film of the medication to||
1946|033|H|the affected area and gently rub in as directed by your doctor,||
1946|034|H|usually 2 times daily. Do not bandage, cover, or wrap the area||
1946|035|H|unless directed to do so by your doctor.||
1946|036|H|   After applying the medication, wash your hands unless you are||
1946|037|H|using this medication to treat the hands. When applying this||
1946|038|H|medication near the eyes, avoid getting it in the eyes because||
1946|039|H|this may worsen or cause glaucoma. Also, avoid getting this||
1946|040|H|medication in the nose or mouth. If you get the medication in||
1946|041|H|these areas, rinse with plenty of water.||
1946|042|H|   Use this medication only for the condition for which it was||
1946|043|H|prescribed. Do not use it for longer than prescribed.||
1946|044|H|   Tell your doctor if your condition lasts or gets worse after 2||
1946|045|H|weeks.||
1946|046|B|||
1946|047|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
1946|048|S|swelling, or redness of the skin may occur when this medication||
1946|049|S|is first applied to the skin. If any of these effects last or get||
1946|050|S|worse, tell your doctor or pharmacist promptly.||
1946|051|S|   Remember that this medication has been prescribed because your||
1946|052|S|doctor has judged that the benefit to you is greater than the||
1946|053|S|risk of side effects. Many people using this medication do not||
1946|054|S|have serious side effects.||
1946|055|S|   Tell your doctor right away if you have any serious side||
1946|056|S|effects, including: stretch marks, skin thinning/discoloration,||
1946|057|S|acne, extreme/unwanted hair growth, small red bumps on the skin||
1946|058|S|(folliculitis).||
1946|059|S|   Using this medication for a long time or for repeated times||
1946|060|S|may result in a new infection (such as fungal infection). Contact||
1946|061|S|your doctor if you notice signs of a new infection.||
1946|062|S|   Rarely, it is possible this medication will be absorbed from||
1946|063|S|the skin into the bloodstream. This can lead to side effects of||
1946|064|S|too much corticosteroid. These side effects are more likely in||
1946|065|S|children, and in people who use this medication for a long time||
1946|066|S|or over large areas of the skin. Tell your doctor right away if||
1946|067|S|any of the following side effects occur: unusual/extreme||
1946|068|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
1946|069|S|thirst/urination, vision problems.||
1946|070|S|   A very serious allergic reaction to this drug is rare.||
1946|071|S|However, get medical help right away if you notice any symptoms||
1946|072|S|of a serious allergic reaction, including: rash, itching/swelling||
1946|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1946|074|S|breathing.||
1946|075|S|   This is not a complete list of possible side effects. If you||
1946|076|S|notice other effects not listed above, contact your doctor or||
1946|077|S|pharmacist.||
1946|078|S|   In the US -||
1946|079|S|   Call your doctor for medical advice about side effects. You||
1946|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1946|081|S|www.fda.gov/medwatch.||
1946|082|S|   In Canada - Call your doctor for medical advice about side||
1946|083|S|effects. You may report side effects to Health Canada at||
1946|084|S|1-866-234-2345.||
1946|085|B|||
1946|086|P|PRECAUTIONS:  Before using this product, tell your doctor or||
1946|087|P|pharmacist if you are allergic to fusidic acid or betamethasone||
1946|088|P|valerate; or to other corticosteroids (such as hydrocortisone,||
1946|089|P|prednisone); or if you have any other allergies. This product may||
1946|090|P|contain inactive ingredients, which can cause allergic reactions||
1946|091|P|or other problems. Talk to your pharmacist for more details.||
1946|092|P|   Before using this medication, tell your doctor or pharmacist||
1946|093|P|your medical history, especially of: poor blood circulation,||
1946|094|P|diabetes, immune system problems.||
1946|095|P|   Do not use this product to treat an area of skin that has a||
1946|096|P|fungal infection, infection not related to eczema, or skin||
1946|097|P|condition related to tuberculosis or syphilis. It should also not||
1946|098|P|be used to treat skin conditions such as rash around the mouth,||
1946|099|P|red flushed facial skin (rosacea), or rash after receiving a||
1946|100|P|vaccine.||
1946|101|P|   Rarely, using corticosteroid medications for a long time or||
1946|102|P|over large areas of skin can make it more difficult for your body||
1946|103|P|to respond to physical stress. Before having surgery or emergency||
1946|104|P|treatment, or if you get a serious illness/injury, tell your||
1946|105|P|doctor or dentist that you are using this medication or have used||
1946|106|P|this medication within the past few months.||
1946|107|P|   Though it is unlikely, this medication may temporarily slow||
1946|108|P|down a child's growth if used for a long time. See the doctor||
1946|109|P|regularly so your child's height can be checked.||
1946|110|P|   During pregnancy, this medication should be used only when||
1946|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
1946|112|P|   It is unknown if this drug passes into breast milk. Consult||
1946|113|P|your doctor before breastfeeding.||
1946|114|B|||
1946|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1946|116|I|medications work or increase your risk for serious side effects.||
1946|117|I|This document does not contain all possible drug interactions.||
1946|118|I|Keep a list of all the products you use (including||
1946|119|I|prescription/nonprescription drugs and herbal products) and share||
1946|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1946|121|I|the dosage of any medicines without your doctor's approval.||
1946|122|B|||
1946|123|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1946|124|O|has overdosed and has serious symptoms such as passing out or||
1946|125|O|trouble breathing, call 911. Otherwise, call a poison control||
1946|126|O|center right away. US residents can call 1-800-222-1222. Canada||
1946|127|O|residents can call 1-844-764-7669.||
1946|128|B|||
1946|129|N|NOTES:  Do not share this medication with others.||
1946|130|N|   This medication has been prescribed for your current condition||
1946|131|N|only. Do not use it later for other skin problems unless your||
1946|132|N|doctor tells you to. A different medication may be needed in||
1946|133|N|those cases.||
1946|134|N|   If you are using this medication for a longer time or over a||
1946|135|N|large area of skin, lab and/or medical tests (such as adrenal||
1946|136|N|function) may be done. Keep all medical and lab appointments.||
1946|137|B|||
1946|138|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1946|139|D|If it is near the time of the next dose, skip the missed dose.||
1946|140|D|Use your next dose at the regular time. Do not double the dose to||
1946|141|D|catch up.||
1946|142|B|||
1946|143|R|STORAGE:  Store at room temperature. Once the tube is opened,||
1946|144|R|this medication expires after 3 months. Keep all medications away||
1946|145|R|from children and pets.||
1946|146|R|   Do not flush medications down the toilet or pour them into a||
1946|147|R|drain unless instructed to do so. Properly discard this product||
1946|148|R|when it is expired or no longer needed. Consult your pharmacist||
1946|149|R|or local waste disposal company.||
1946|150|B|||
1946|151|A|Information last revised January 2025.||
1946|152|A|Copyright(c) 2025 First Databank, Inc.||
1946|153|B|||
1947|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1947|002|Z|does NOT have all possible information about this product. This||
1947|003|Z|information does not assure that this product is safe, effective,||
1947|004|Z|or appropriate for you. This information is not individual||
1947|005|Z|medical advice and does not substitute for the advice of your||
1947|006|Z|health care professional. Always ask your health care||
1947|007|Z|professional for complete information about this product and your||
1947|008|Z|specific health needs.||
1947|009|B|||
1947|010|T|SODIUM ZIRCONIUM CYCLOSILICATE - ORAL||
1947|011|F|(SOE-dee-um zir-KOE-nee-um SYE-kloe-SIL-i-kate)||
1947|012|B|||
1947|013|C|COMMON BRAND NAME(S): Lokelma||
1947|014|B|||
1947|015|U|USES:  This medication is used to treat high levels of potassium||
1947|016|U|in the blood. It works by binding to potassium in the gut. This||
1947|017|U|medication does not work right away, and should not be used to||
1947|018|U|treat life-threatening high levels of potassium. High potassium||
1947|019|U|levels can cause symptoms such as nausea, muscle||
1947|020|U|weakness/tiredness, irregular heartbeats, or paralysis.||
1947|021|B|||
1947|022|H|HOW TO USE:  Take this medication by mouth as directed by your||
1947|023|H|doctor. If you are taking other medications, take them at least 2||
1947|024|H|hours before or 2 hours after taking this medication. Your doctor||
1947|025|H|may direct you to start taking this medication 3 times a day for||
1947|026|H|the first 48 hours, then decrease to once daily, or once every||
1947|027|H|other day. Patients on dialysis should only take this medication||
1947|028|H|on non-dialysis days. Follow your doctor's instructions||
1947|029|H|carefully. The dosage is based on your medical condition and||
1947|030|H|response to treatment. Your doctor will order blood tests to||
1947|031|H|monitor your response to this medication.||
1947|032|H|   This medication must be mixed before taking. Open the packet||
1947|033|H|and pour the contents into a drinking glass with about 3||
1947|034|H|tablespoonfuls or more (45 milliliters or more) of water. Stir,||
1947|035|H|then drink the mixture right away. If there is any powder left in||
1947|036|H|the glass, add more water, stir and drink again. Repeat until no||
1947|037|H|powder is left in the glass to make sure you take all of it.||
1947|038|H|   Use this medication regularly to get the most benefit from it.||
1947|039|H|To help you remember, take it at the same time(s) each day.||
1947|040|H|   Tell your doctor if your condition lasts or gets worse.||
1947|041|B|||
1947|042|S|SIDE EFFECTS:  Swelling in your ankles, feet, or hands may occur.||
1947|043|S|If any of these effects last or get worse, tell your doctor or||
1947|044|S|pharmacist promptly.||
1947|045|S|   Remember that this medication has been prescribed because your||
1947|046|S|doctor has judged that the benefit to you is greater than the||
1947|047|S|risk of side effects. Many people using this medication do not||
1947|048|S|have serious side effects.||
1947|049|S|   A very serious allergic reaction to this drug is rare.||
1947|050|S|However, get medical help right away if you notice any symptoms||
1947|051|S|of a serious allergic reaction, including: rash, itching/swelling||
1947|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1947|053|S|breathing.||
1947|054|S|   This is not a complete list of possible side effects. If you||
1947|055|S|notice other effects not listed above, contact your doctor or||
1947|056|S|pharmacist.||
1947|057|S|   In the US -||
1947|058|S|   Call your doctor for medical advice about side effects. You||
1947|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1947|060|S|www.fda.gov/medwatch.||
1947|061|S|   In Canada - Call your doctor for medical advice about side||
1947|062|S|effects. You may report side effects to Health Canada at||
1947|063|S|1-866-234-2345.||
1947|064|B|||
1947|065|P|PRECAUTIONS:  Before taking sodium zirconium cyclosilicate, tell||
1947|066|P|your doctor or pharmacist if you are allergic to it; or if you||
1947|067|P|have any other allergies. This product may contain inactive||
1947|068|P|ingredients, which can cause allergic reactions or other||
1947|069|P|problems. Talk to your pharmacist for more details.||
1947|070|P|   Before using this medication, tell your doctor or pharmacist||
1947|071|P|your medical history, especially of: stomach/intestinal problems||
1947|072|P|(such as constipation, blockage), conditions affected by the salt||
1947|073|P|in this medication (such as heart failure, high blood pressure,||
1947|074|P|swelling/edema), kidney problems.||
1947|075|P|   This medication contains salt (sodium). Before taking this||
1947|076|P|medication, tell your doctor or pharmacist if you are on a||
1947|077|P|low-salt diet. Your doctor may direct you to adjust the salt in||
1947|078|P|your diet.||
1947|079|P|   People on dialysis may be more sensitive to the effects of||
1947|080|P|this drug, especially when they are sick (such as having||
1947|081|P|diarrhea, eating or drinking less than usual). Tell your doctor||
1947|082|P|right away if you become sick or have any of these conditions.||
1947|083|P|   Before having an X-ray of your stomach/abdomen, tell X-ray||
1947|084|P|personnel that you are taking this medication.||
1947|085|P|   Before having surgery, tell your doctor or dentist about all||
1947|086|P|the products you use (including prescription drugs,||
1947|087|P|nonprescription drugs, and herbal products).||
1947|088|P|   Tell your doctor if you are pregnant before using this||
1947|089|P|medication.||
1947|090|P|   This medication is unlikely to pass into breast milk. Consult||
1947|091|P|your doctor before breastfeeding.||
1947|092|B|||
1947|093|I|DRUG INTERACTIONS:  See also How to Use section.||
1947|094|I|   Drug interactions may change how your medications work or||
1947|095|I|increase your risk for serious side effects. This document does||
1947|096|I|not contain all possible drug interactions. Keep a list of all||
1947|097|I|the products you use (including prescription/nonprescription||
1947|098|I|drugs and herbal products) and share it with your doctor and||
1947|099|I|pharmacist. Do not start, stop, or change the dosage of any||
1947|100|I|medicines without your doctor's approval.||
1947|101|B|||
1947|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1947|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1947|104|O|poison control center right away. US residents can call||
1947|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1947|106|B|||
1947|107|N|NOTES:  Do not share this medication with others.||
1947|108|N|   Lab and/or medical tests (such as potassium blood levels) must||
1947|109|N|be done while you are taking this medication. Keep all medical||
1947|110|N|and lab appointments.||
1947|111|B|||
1947|112|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1947|113|D|remember. If it is near the time of the next dose, skip the||
1947|114|D|missed dose. Take your next dose at the regular time. Do not||
1947|115|D|double the dose to catch up.||
1947|116|B|||
1947|117|R|STORAGE:  Store at room temperature away from light and moisture.||
1947|118|R|Do not store in the bathroom. Keep all medications away from||
1947|119|R|children and pets.||
1947|120|R|   Do not flush medications down the toilet or pour them into a||
1947|121|R|drain unless instructed to do so. Properly discard this product||
1947|122|R|when it is expired or no longer needed. Consult your pharmacist||
1947|123|R|or local waste disposal company.||
1947|124|B|||
1947|125|A|Information last revised May 2024.||
1947|126|A|Copyright(c) 2025 First Databank, Inc.||
1947|127|B|||
1948|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1948|002|Z|does NOT have all possible information about this product. This||
1948|003|Z|information does not assure that this product is safe, effective,||
1948|004|Z|or appropriate for you. This information is not individual||
1948|005|Z|medical advice and does not substitute for the advice of your||
1948|006|Z|health care professional. Always ask your health care||
1948|007|Z|professional for complete information about this product and your||
1948|008|Z|specific health needs.||
1948|009|B|||
1948|010|T|RISPERIDONE - SUBCUTANEOUS INJECTION||
1948|011|F|(ris-PER-i-done)||
1948|012|B|||
1948|013|C|COMMON BRAND NAME(S): Perseris, Uzedy||
1948|014|B|||
1948|015|W|WARNING:  There may be a slightly increased risk of serious,||
1948|016|W|possibly fatal side effects (such as stroke, heart failure,||
1948|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
1948|018|W|by older adults with dementia. This medication is not approved||
1948|019|W|for the treatment of dementia-related behavior problems. Discuss||
1948|020|W|the risks and benefits of this medication, as well as other||
1948|021|W|effective and possibly safer treatments for dementia-related||
1948|022|W|behavior problems, with the doctor.||
1948|023|B|||
1948|024|U|USES:  This medication is used to treat certain mental/mood||
1948|025|U|disorders (such as schizophrenia, bipolar disorder). Risperidone||
1948|026|U|belongs to a class of drugs known as atypical antipsychotics. It||
1948|027|U|works by helping to restore the balance of certain natural||
1948|028|U|substances in the brain.||
1948|029|B|||
1948|030|H|HOW TO USE:  This medication is given by injection under the skin||
1948|031|H|of the abdomen or upper arm by a health care professional. It is||
1948|032|H|given as directed by your doctor. Depending on the indication and||
1948|033|H|brand, this medication is usually given once every 1 or 2 months.||
1948|034|H|It is used to switch from taking risperidone by mouth. You should||
1948|035|H|not be taking the medication by mouth while receiving the||
1948|036|H|injection under the skin.||
1948|037|H|   You may have a lump at the injection site for several weeks.||
1948|038|H|This lump will get smaller over time. Do not rub or massage the||
1948|039|H|injection site. Try not to place belts or clothing waistbands on||
1948|040|H|the lump.||
1948|041|H|   The dosage is based on your medical condition, response to||
1948|042|H|treatment, and other medications you may be taking. Be sure to||
1948|043|H|tell your doctor and pharmacist about all the products you use||
1948|044|H|(including prescription drugs, nonprescription drugs, and herbal||
1948|045|H|products).||
1948|046|H|   You should receive this medication regularly to get the most||
1948|047|H|benefit from it. To help you remember, mark your calendar with a||
1948|048|H|reminder. Keep receiving this medication even if you feel well.||
1948|049|H|   Tell your doctor if your condition does not get better or if||
1948|050|H|it gets worse.||
1948|051|B|||
1948|052|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness,||
1948|053|S|constipation, tiredness, drooling, weight gain, or redness/pain||
1948|054|S|at the injection site may occur. If any of these effects last or||
1948|055|S|get worse, tell your doctor or pharmacist promptly.||
1948|056|S|   Dizziness and lightheadedness can increase the risk of||
1948|057|S|falling. Get up slowly when rising from a sitting or lying||
1948|058|S|position.||
1948|059|S|   Remember that this medication has been prescribed because your||
1948|060|S|doctor has judged that the benefit to you is greater than the||
1948|061|S|risk of side effects. Many people using this medication do not||
1948|062|S|have serious side effects.||
1948|063|S|   Tell your doctor right away if you have any serious side||
1948|064|S|effects, including: difficulty swallowing, muscle spasms, shaking||
1948|065|S|(tremor), mental/mood changes (such as anxiety, restlessness),||
1948|066|S|interrupted breathing during sleep.||
1948|067|S|   This medication may rarely make your blood sugar rise, which||
1948|068|S|can cause or worsen diabetes. Tell your doctor right away if you||
1948|069|S|have symptoms of high blood sugar such as increased||
1948|070|S|thirst/urination. If you already have diabetes, check your blood||
1948|071|S|sugar regularly as directed and share the results with your||
1948|072|S|doctor. Your doctor may need to adjust your diabetes medication,||
1948|073|S|exercise program, or diet.||
1948|074|S|   This drug may also cause significant weight gain and a rise in||
1948|075|S|your blood cholesterol (or triglyceride) levels. These effects,||
1948|076|S|along with diabetes, may increase your risk for developing heart||
1948|077|S|disease. Discuss the risks and benefits of treatment with your||
1948|078|S|doctor. (See also Notes section.)||
1948|079|S|   Risperidone may rarely cause a condition known as tardive||
1948|080|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1948|081|S|your doctor right away if you develop any unusual/uncontrolled||
1948|082|S|movements (especially of the face, lips, mouth, tongue, arms or||
1948|083|S|legs).||
1948|084|S|   This medication may increase a certain natural substance||
1948|085|S|(prolactin) made by your body. For females, this increase in||
1948|086|S|prolactin may result in unwanted breast milk, missed/stopped||
1948|087|S|periods, or difficulty becoming pregnant. For males, it may||
1948|088|S|result in decreased sexual ability, inability to produce sperm,||
1948|089|S|or enlarged breasts. If you develop any of these symptoms, tell||
1948|090|S|your doctor right away.||
1948|091|S|   Get medical help right away if you have any very serious side||
1948|092|S|effects, including: severe dizziness, fainting, seizures.||
1948|093|S|   This medication may rarely cause a very serious condition||
1948|094|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1948|095|S|right away if you have any of the following symptoms: fever,||
1948|096|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1948|097|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1948|098|S|signs of kidney problems (such as change in the amount of urine).||
1948|099|S|   Rarely, males may have a painful or prolonged erection lasting||
1948|100|S|4 or more hours. If this occurs, stop using this drug and get||
1948|101|S|medical help right away, or permanent problems could occur.||
1948|102|S|   A very serious allergic reaction to this drug is rare.||
1948|103|S|However, get medical help right away if you notice any symptoms||
1948|104|S|of a serious allergic reaction, including: fever, swollen lymph||
1948|105|S|nodes, rash, itching/swelling (especially of the||
1948|106|S|face/tongue/throat), severe dizziness, trouble breathing.||
1948|107|S|   This is not a complete list of possible side effects. If you||
1948|108|S|notice other effects not listed above, contact your doctor or||
1948|109|S|pharmacist.||
1948|110|S|   In the US -||
1948|111|S|   Call your doctor for medical advice about side effects. You||
1948|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1948|113|S|www.fda.gov/medwatch.||
1948|114|S|   In Canada - Call your doctor for medical advice about side||
1948|115|S|effects. You may report side effects to Health Canada at||
1948|116|S|1-866-234-2345.||
1948|117|B|||
1948|118|P|PRECAUTIONS:  Before using risperidone, tell your doctor or||
1948|119|P|pharmacist if you are allergic to it; or to paliperidone; or if||
1948|120|P|you have any other allergies. This product may contain inactive||
1948|121|P|ingredients, which can cause allergic reactions or other||
1948|122|P|problems. Talk to your pharmacist for more details.||
1948|123|P|   Before using this medication, tell your doctor or pharmacist||
1948|124|P|your medical history, especially of: liver disease, kidney||
1948|125|P|disease, seizures, difficulty swallowing, low white blood cell||
1948|126|P|count, Parkinson's disease, dementia, certain eye problems||
1948|127|P|(cataracts, glaucoma), personal or family history of diabetes,||
1948|128|P|heart disease, high cholesterol/triglyceride levels, breathing||
1948|129|P|trouble during sleep (sleep apnea).||
1948|130|P|   Risperidone may cause a condition that affects the heart||
1948|131|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1948|132|P|serious (rarely fatal) fast/irregular heartbeat and other||
1948|133|P|symptoms (such as severe dizziness, fainting) that need medical||
1948|134|P|attention right away.||
1948|135|P|   The risk of QT prolongation may be increased if you have||
1948|136|P|certain medical conditions or are taking other drugs that may||
1948|137|P|cause QT prolongation. Before using risperidone, tell your doctor||
1948|138|P|or pharmacist of all the drugs you take and if you have any of||
1948|139|P|the following conditions: certain heart problems (heart failure,||
1948|140|P|slow heartbeat, QT prolongation in the EKG), family history of||
1948|141|P|certain heart problems (QT prolongation in the EKG, sudden||
1948|142|P|cardiac death).||
1948|143|P|   Low levels of potassium or magnesium in the blood may also||
1948|144|P|increase your risk of QT prolongation. This risk may increase if||
1948|145|P|you use certain drugs (such as diuretics/"water pills") or if you||
1948|146|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1948|147|P|Talk to your doctor about using risperidone safely.||
1948|148|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1948|149|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1948|150|P|machinery, or do anything that needs alertness until you can do||
1948|151|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1948|152|P|are using marijuana (cannabis).||
1948|153|P|   Before having surgery (including cataract/glaucoma eye||
1948|154|P|surgery), tell your doctor or dentist if you are using or have||
1948|155|P|ever used this medication, and about all the other products you||
1948|156|P|use (including prescription drugs, nonprescription drugs, and||
1948|157|P|herbal products).||
1948|158|P|   This medication may make you sweat less, making you more||
1948|159|P|likely to get heat stroke. Avoid doing things that may cause you||
1948|160|P|to overheat, such as hard work or exercise in hot weather, or||
1948|161|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1948|162|P|and dress lightly. If you overheat, quickly look for a place to||
1948|163|P|cool down and rest. Get medical help right away if you have a||
1948|164|P|fever that does not go away, mental/mood changes, headache, or||
1948|165|P|dizziness.||
1948|166|P|   Older adults may be more sensitive to the side effects of this||
1948|167|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
1948|168|P|prolongation (see above). Drowsiness, dizziness, and||
1948|169|P|lightheadedness can increase the risk of falling.||
1948|170|P|   During pregnancy, this medication should be used only when||
1948|171|P|clearly needed. Babies born to mothers who have used this drug||
1948|172|P|during the last 3 months of pregnancy may rarely develop symptoms||
1948|173|P|including muscle stiffness or shakiness, drowsiness,||
1948|174|P|feeding/breathing difficulties, or non-stop crying. If you notice||
1948|175|P|any of these symptoms in your newborn especially during their||
1948|176|P|first month, tell the doctor right away.||
1948|177|P|   Since untreated mental/mood problems (such as schizophrenia,||
1948|178|P|bipolar disorder) can be a serious condition, do not stop taking||
1948|179|P|this medication unless directed by your doctor. If you are||
1948|180|P|planning pregnancy, become pregnant, or think you may be||
1948|181|P|pregnant, discuss with your doctor right away the benefits and||
1948|182|P|risks of using this medication during pregnancy.||
1948|183|P|   This medication passes into breast milk and may have||
1948|184|P|undesirable effects on a nursing infant. Tell the doctor right||
1948|185|P|away if your baby develops symptoms such as muscle stiffness or||
1948|186|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
1948|187|P|your doctor before breastfeeding.||
1948|188|B|||
1948|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1948|190|I|medications work or increase your risk for serious side effects.||
1948|191|I|This document does not contain all possible drug interactions.||
1948|192|I|Keep a list of all the products you use (including||
1948|193|I|prescription/nonprescription drugs and herbal products) and share||
1948|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
1948|195|I|the dosage of any medicines without your doctor's approval.||
1948|196|I|   A product that may interact with this drug is: metoclopramide.||
1948|197|I|   Tell your doctor or pharmacist if you are taking other||
1948|198|I|products that cause drowsiness such as opioid pain or cough||
1948|199|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1948|200|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1948|201|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1948|202|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1948|203|I|diphenhydramine).||
1948|204|I|   Check the labels on all your medicines (such as allergy or||
1948|205|I|cough-and-cold products) because they may contain ingredients||
1948|206|I|that cause drowsiness. Ask your pharmacist about using those||
1948|207|I|products safely.||
1948|208|B|||
1948|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1948|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1948|211|O|poison control center right away. US residents can call||
1948|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1948|213|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
1948|214|O|fast/irregular heartbeat, unusual/uncontrolled movements,||
1948|215|O|seizures.||
1948|216|B|||
1948|217|N|NOTES:  Lab and/or medical tests (such as blood sugar, weight,||
1948|218|N|blood pressure, blood cholesterol/triglyceride levels) should be||
1948|219|N|done while you are using this medication. Keep all medical and||
1948|220|N|lab appointments.||
1948|221|B|||
1948|222|D|MISSED DOSE:  It is important to get each dose of this medication||
1948|223|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1948|224|D|right away for a new dosing schedule.||
1948|225|B|||
1948|226|R|STORAGE:  Not applicable. This medication is given in a hospital||
1948|227|R|or clinic and will not be stored at home.||
1948|228|B|||
1948|229|A|Information last revised October 2025.||
1948|230|A|Copyright(c) 2025 First Databank, Inc.||
1948|231|B|||
1949|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1949|002|Z|does NOT have all possible information about this product. This||
1949|003|Z|information does not assure that this product is safe, effective,||
1949|004|Z|or appropriate for you. This information is not individual||
1949|005|Z|medical advice and does not substitute for the advice of your||
1949|006|Z|health care professional. Always ask your health care||
1949|007|Z|professional for complete information about this product and your||
1949|008|Z|specific health needs.||
1949|009|B|||
1949|010|T|PATISIRAN LIPID COMPLEX - INJECTION||
1949|011|F|(PAT-i-SIR-an)||
1949|012|B|||
1949|013|C|COMMON BRAND NAME(S): Onpattro||
1949|014|B|||
1949|015|U|USES:  This medication is used to treat nerve problems due to a||
1949|016|U|certain inherited condition (transthyretin-mediated amyloidosis).||
1949|017|U|This condition causes a protein that your body normally makes||
1949|018|U|(transthyretin-TTR), to change shape and build up in different||
1949|019|U|parts of your body, which can affect the nerves, heart, and||
1949|020|U|stomach/intestines. This medication works by decreasing the||
1949|021|U|buildup of TTR in your body.||
1949|022|B|||
1949|023|H|HOW TO USE:  This medication is given by injection into a vein by||
1949|024|H|a health care professional. It is given as directed by your||
1949|025|H|doctor, usually once every 3 weeks. The injection is given over||
1949|026|H|about 80 minutes. The dosage is based on your medical condition,||
1949|027|H|weight, and response to treatment. To decrease the risk of side||
1949|028|H|effects during the injection, your doctor will prescribe other||
1949|029|H|medications (such as acetaminophen, dexamethasone,||
1949|030|H|diphenhydramine) for you to use before each injection. Carefully||
1949|031|H|follow your doctor's treatment directions.||
1949|032|H|   Use this medication regularly to get the most benefit from it.||
1949|033|H|To help you remember, mark your calendar with a reminder.||
1949|034|H|   Tell your doctor if your condition does not get better or if||
1949|035|H|it gets worse.||
1949|036|B|||
1949|037|S|SIDE EFFECTS:  Flushing, chills, dizziness, shortness of breath,||
1949|038|S|chest discomfort/pain, fast/pounding heartbeat, or facial||
1949|039|S|swelling may occur during the injection. Back/neck/muscle/joint||
1949|040|S|pain, nausea, abdominal pain, headache, or tiredness may also||
1949|041|S|occur. Tell your doctor right away if you have side effects||
1949|042|S|during your injection. Your doctor may manage some side effects||
1949|043|S|with other medications or by giving the injection over a longer||
1949|044|S|time.||
1949|045|S|   Cold-like symptoms (such as runny/stuffy nose, sore throat),||
1949|046|S|upset stomach, muscle spasms, a feeling of spinning (vertigo), or||
1949|047|S|pain/redness/swelling at the injection site may also occur. If||
1949|048|S|any of these effects last or get worse, tell your doctor or||
1949|049|S|pharmacist promptly.||
1949|050|S|   Remember that this medication has been prescribed because your||
1949|051|S|doctor has judged that the benefit to you is greater than the||
1949|052|S|risk of side effects. Many people using this medication do not||
1949|053|S|have serious side effects.||
1949|054|S|   Get medical help right away if you have any very serious side||
1949|055|S|effects, including: fast/slow/irregular heartbeat, fainting.||
1949|056|S|   This medication decreases vitamin A levels in your blood. Ask||
1949|057|S|your doctor about taking a vitamin A supplement. Tell your doctor||
1949|058|S|right away if you develop signs of a lack of vitamin A,||
1949|059|S|especially vision changes such as dry eyes, blurred vision, or||
1949|060|S|trouble seeing in dim light (night blindness).||
1949|061|S|   A very serious allergic reaction to this drug is rare.||
1949|062|S|However, get medical help right away if you notice any symptoms||
1949|063|S|of a serious allergic reaction, including: rash, itching/swelling||
1949|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1949|065|S|breathing.||
1949|066|S|   This is not a complete list of possible side effects. If you||
1949|067|S|notice other effects not listed above, contact your doctor or||
1949|068|S|pharmacist.||
1949|069|S|   In the US -||
1949|070|S|   Call your doctor for medical advice about side effects. You||
1949|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1949|072|S|www.fda.gov/medwatch.||
1949|073|S|   In Canada - Call your doctor for medical advice about side||
1949|074|S|effects. You may report side effects to Health Canada at||
1949|075|S|1-866-234-2345.||
1949|076|B|||
1949|077|P|PRECAUTIONS:  Before using patisiran lipid complex, tell your||
1949|078|P|doctor or pharmacist if you are allergic to it; or if you have||
1949|079|P|any other allergies. This product may contain inactive||
1949|080|P|ingredients, which can cause allergic reactions or other||
1949|081|P|problems. Talk to your pharmacist for more details.||
1949|082|P|   Before using this medication, tell your doctor or pharmacist||
1949|083|P|your medical history.||
1949|084|P|   Before having surgery, tell your doctor or dentist about all||
1949|085|P|the products you use (including prescription drugs,||
1949|086|P|nonprescription drugs, and herbal products).||
1949|087|P|   During pregnancy, this medication should be used only when||
1949|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
1949|089|P|   It is unknown if this medication passes into breast milk.||
1949|090|P|Consult your doctor before breastfeeding.||
1949|091|B|||
1949|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1949|093|I|medications work or increase your risk for serious side effects.||
1949|094|I|This document does not contain all possible drug interactions.||
1949|095|I|Keep a list of all the products you use (including||
1949|096|I|prescription/nonprescription drugs and herbal products) and share||
1949|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
1949|098|I|the dosage of any medicines without your doctor's approval.||
1949|099|B|||
1949|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1949|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1949|102|O|poison control center right away. US residents can call||
1949|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1949|104|B|||
1949|105|N|NOTES:  Lab and/or medical tests may be done while you are using||
1949|106|N|this medication. Keep all medical and lab appointments.||
1949|107|B|||
1949|108|D|MISSED DOSE:  It is important to get each dose of this medication||
1949|109|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1949|110|D|right away for a new dosing schedule.||
1949|111|B|||
1949|112|R|STORAGE:  Not applicable. This medication is given in a hospital||
1949|113|R|or clinic or doctor's office and will not be stored at home.||
1949|114|B|||
1949|115|A|Information last revised October 2024.||
1949|116|A|Copyright(c) 2025 First Databank, Inc.||
1949|117|B|||
1950|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1950|002|Z|does NOT have all possible information about this product. This||
1950|003|Z|information does not assure that this product is safe, effective,||
1950|004|Z|or appropriate for you. This information is not individual||
1950|005|Z|medical advice and does not substitute for the advice of your||
1950|006|Z|health care professional. Always ask your health care||
1950|007|Z|professional for complete information about this product and your||
1950|008|Z|specific health needs.||
1950|009|B|||
1950|010|T|TILDRAKIZUMAB - INJECTION||
1950|011|F|(TIL-dra-KIZ-ue-mab-ASMN)||
1950|012|B|||
1950|013|C|COMMON BRAND NAME(S): Ilumya||
1950|014|B|||
1950|015|U|USES:  This medication is used to treat moderate to severe plaque||
1950|016|U|psoriasis. Tildrakizumab belongs to a class of drugs known as||
1950|017|U|monoclonal antibodies. It works by blocking a certain natural||
1950|018|U|substance in your body (interleukin-23) that may lead to the||
1950|019|U|overgrowth of skin cells and redness/swelling seen in plaque||
1950|020|U|psoriasis. Tildrakizumab can help lessen the symptoms of plaque||
1950|021|U|psoriasis, including red, scaly, itchy patches of skin.||
1950|022|B|||
1950|023|H|HOW TO USE:  Read the Medication Guide provided by your||
1950|024|H|pharmacist before you start using tildrakizumab and each time you||
1950|025|H|get a refill. If you have any questions, ask your doctor or||
1950|026|H|pharmacist.||
1950|027|H|   Before treatment with this medication, your doctor will test||
1950|028|H|you for tuberculosis (TB). Your doctor should also monitor you||
1950|029|H|for symptoms of TB during and after treatment with this drug. If||
1950|030|H|needed, treatment for tuberculosis or other infections should be||
1950|031|H|given before receiving this medication.||
1950|032|H|   This medication is given by injection under the skin by a||
1950|033|H|health care professional. It is given as directed by your doctor.||
1950|034|H|After the first dose, another dose is usually given 4 weeks||
1950|035|H|later, followed by doses every 12 weeks. The injection is given||
1950|036|H|in the upper arms, thighs, or abdomen (at least 2 inches from||
1950|037|H|your belly button). The dosage is based on your medical condition||
1950|038|H|and response to treatment.||
1950|039|H|   The injection site should be changed each time to lessen||
1950|040|H|injury under the skin. Your health care provider should avoid||
1950|041|H|injecting into skin that is tender, bruised, red, hard, thick,||
1950|042|H|scaly, or affected by psoriasis. To lessen bruising, do not rub||
1950|043|H|the injection site after a shot.||
1950|044|H|   Use this medication regularly to get the most benefit from it.||
1950|045|H|To help you remember, mark your calendar with a reminder.||
1950|046|H|   Tell your doctor if your condition does not get better or if||
1950|047|H|it gets worse.||
1950|048|B|||
1950|049|S|SIDE EFFECTS:  Bruising, redness, itching, pain, or swelling at||
1950|050|S|the injection site may occur. If any of these effects last or get||
1950|051|S|worse, tell your doctor or pharmacist promptly.||
1950|052|S|   Remember that this medication has been prescribed because your||
1950|053|S|doctor has judged that the benefit to you is greater than the||
1950|054|S|risk of side effects. Many people using this medication do not||
1950|055|S|have serious side effects.||
1950|056|S|   This medication may lower your ability to fight infections.||
1950|057|S|This may make you more likely to get a serious (rarely fatal)||
1950|058|S|infection or make any infection you have worse. Tell your doctor||
1950|059|S|right away if you have any signs of infection (such as sore||
1950|060|S|throat that doesn't go away, fever, chills).||
1950|061|S|   A very serious allergic reaction to this drug is rare.||
1950|062|S|However, get medical help right away if you notice any symptoms||
1950|063|S|of a serious allergic reaction, including: rash, itching/swelling||
1950|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1950|065|S|breathing.||
1950|066|S|   This is not a complete list of possible side effects. If you||
1950|067|S|notice other effects not listed above, contact your doctor or||
1950|068|S|pharmacist.||
1950|069|S|   In the US -||
1950|070|S|   Call your doctor for medical advice about side effects. You||
1950|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1950|072|S|www.fda.gov/medwatch.||
1950|073|S|   In Canada - Call your doctor for medical advice about side||
1950|074|S|effects. You may report side effects to Health Canada at||
1950|075|S|1-866-234-2345.||
1950|076|B|||
1950|077|P|PRECAUTIONS:  Before using tildrakizumab, tell your doctor or||
1950|078|P|pharmacist if you are allergic to it; or if you have any other||
1950|079|P|allergies. This product may contain inactive ingredients, which||
1950|080|P|can cause allergic reactions or other problems. Talk to your||
1950|081|P|pharmacist for more details.||
1950|082|P|   Before using this medication, tell your doctor or pharmacist||
1950|083|P|your medical history, especially of: current/recent/returning||
1950|084|P|infection (such as tuberculosis, herpes).||
1950|085|P|   Tildrakizumab can make you more likely to get infections or||
1950|086|P|may make current infections worse. Stay away from anyone who has||
1950|087|P|an infection that may easily spread (such as chickenpox,||
1950|088|P|COVID-19, measles, flu). Talk to your doctor if you have been||
1950|089|P|exposed to an infection or for more details.||
1950|090|P|   Tell your health care professional that you are using||
1950|091|P|tildrakizumab before having any immunizations/vaccinations. Avoid||
1950|092|P|contact with people who have recently received live vaccines||
1950|093|P|(such as flu vaccine inhaled through the nose).||
1950|094|P|   Before having surgery, tell your doctor or dentist about all||
1950|095|P|the products you use (including prescription drugs,||
1950|096|P|nonprescription drugs, and herbal products).||
1950|097|P|   During pregnancy, this medication should be used only when||
1950|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
1950|099|P|   It is unknown if this medication passes into breast milk.||
1950|100|P|Consult your doctor before breastfeeding.||
1950|101|B|||
1950|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1950|103|I|medications work or increase your risk for serious side effects.||
1950|104|I|This document does not contain all possible drug interactions.||
1950|105|I|Keep a list of all the products you use (including||
1950|106|I|prescription/nonprescription drugs and herbal products) and share||
1950|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1950|108|I|the dosage of any medicines without your doctor's approval.||
1950|109|B|||
1950|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1950|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1950|112|O|poison control center right away. US residents can call||
1950|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1950|114|B|||
1950|115|N|NOTES:  Keep all medical and lab appointments.||
1950|116|B|||
1950|117|D|MISSED DOSE:  It is important to get each dose of this medication||
1950|118|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1950|119|D|right away for a new dosing schedule.||
1950|120|B|||
1950|121|R|STORAGE:  Not applicable. This medication is given in a hospital||
1950|122|R|or clinic or doctor's office and will not be stored at home.||
1950|123|B|||
1950|124|A|Information last revised April 2025.||
1950|125|A|Copyright(c) 2025 First Databank, Inc.||
1950|126|B|||
1951|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1951|002|Z|does NOT have all possible information about this product. This||
1951|003|Z|information does not assure that this product is safe, effective,||
1951|004|Z|or appropriate for you. This information is not individual||
1951|005|Z|medical advice and does not substitute for the advice of your||
1951|006|Z|health care professional. Always ask your health care||
1951|007|Z|professional for complete information about this product and your||
1951|008|Z|specific health needs.||
1951|009|B|||
1951|010|T|MOGAMULIZUMAB - INJECTION||
1951|011|F|(moe-GAM-ue-LIZ-ue-mab)||
1951|012|B|||
1951|013|C|COMMON BRAND NAME(S): Poteligeo||
1951|014|B|||
1951|015|U|USES:  This medication is used to treat certain cancers (such as||
1951|016|U|mycosis fungoides, Sezary syndrome). Mogamulizumab belongs to a||
1951|017|U|class of drugs known as monoclonal antibodies. It works by||
1951|018|U|changing the action of your own immune system, directing it to||
1951|019|U|attack cancer cells. This effect helps slow or stop the growth of||
1951|020|U|cancer cells.||
1951|021|B|||
1951|022|H|HOW TO USE:  This medication is given by injection into a vein by||
1951|023|H|a health care professional. It is given as directed by your||
1951|024|H|doctor, usually over at least 60 minutes. The first 4 doses are||
1951|025|H|usually given 7 days apart, followed by doses every 2 weeks. The||
1951|026|H|dosage is based on your medical condition and response to||
1951|027|H|treatment.||
1951|028|H|   Infusion reactions may happen during and soon after the||
1951|029|H|infusion of this drug. Your doctor may prescribe other||
1951|030|H|medications (such as acetaminophen, diphenhydramine) before each||
1951|031|H|treatment to help prevent these side effects. Tell your doctor||
1951|032|H|right away if you have any symptoms of infusion reactions such as||
1951|033|H|flushing, chills, fever, fast/pounding heartbeat, dizziness, or||
1951|034|H|shortness of breath.||
1951|035|H|   Use this medication regularly to get the most benefit from it.||
1951|036|H|To help you remember, mark your calendar with a reminder.||
1951|037|B|||
1951|038|S|SIDE EFFECTS:  See also How to Use section.||
1951|039|S|   Cold-like symptoms (such as runny/stuffy nose), muscle/joint||
1951|040|S|pain, mouth sores, loss of appetite, tiredness, swelling,||
1951|041|S|dizziness, nausea, diarrhea, or trouble sleeping may occur. If||
1951|042|S|any of these effects last or get worse, tell your doctor or||
1951|043|S|pharmacist promptly.||
1951|044|S|   Temporary hair loss may occur. Normal hair growth should||
1951|045|S|return after treatment has ended.||
1951|046|S|   People using this medication may have serious side effects.||
1951|047|S|However, you have been prescribed this drug because your doctor||
1951|048|S|has judged that the benefit to you is greater than the risk of||
1951|049|S|side effects. Careful monitoring by your doctor may decrease your||
1951|050|S|risk.||
1951|051|S|   This medication may raise your blood pressure. Check your||
1951|052|S|blood pressure regularly and tell your doctor if the results are||
1951|053|S|high. Your doctor may control your blood pressure with||
1951|054|S|medication.||
1951|055|S|   Tell your doctor right away if you have any serious side||
1951|056|S|effects, including: easy bruising/bleeding, mental/mood changes||
1951|057|S|(such as depression), numbness/tingling of arms/legs.||
1951|058|S|   This medication may lower your ability to fight infections.||
1951|059|S|This may make you more likely to get a serious (rarely fatal)||
1951|060|S|infection or make any infection you have worse. Tell your doctor||
1951|061|S|right away if you have any signs of infection (such as sore||
1951|062|S|throat that doesn't go away, fever, chills).||
1951|063|S|   This medication may make your blood sugar rise, which can||
1951|064|S|cause or worsen diabetes. Tell your doctor right away if you have||
1951|065|S|symptoms of high blood sugar such as increased thirst/urination.||
1951|066|S|If you already have diabetes, check your blood sugar regularly as||
1951|067|S|directed and share the results with your doctor. Your doctor may||
1951|068|S|need to adjust your diabetes medication, exercise program, or||
1951|069|S|diet.||
1951|070|S|   This medication sometimes causes side effects due to the rapid||
1951|071|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
1951|072|S|risk, your doctor may add a medication and tell you to drink||
1951|073|S|plenty of fluids. Tell your doctor right away if you have||
1951|074|S|symptoms such as: low back/side pain (flank pain), signs of||
1951|075|S|kidney problems (such as painful urination, pink/bloody urine,||
1951|076|S|change in the amount of urine), muscle spasms/weakness.||
1951|077|S|   Mogamulizumab can commonly cause a rash that is usually not||
1951|078|S|serious. However, you may not be able to tell it apart from a||
1951|079|S|rare rash that could be a sign of a severe reaction. Get medical||
1951|080|S|help right away if you develop a new or worsening rash.||
1951|081|S|   A very serious allergic reaction to this drug is rare.||
1951|082|S|However, get medical help right away if you notice any symptoms||
1951|083|S|of a serious allergic reaction, including: rash, itching/swelling||
1951|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1951|085|S|breathing.||
1951|086|S|   This is not a complete list of possible side effects. If you||
1951|087|S|notice other effects not listed above, contact your doctor or||
1951|088|S|pharmacist.||
1951|089|S|   In the US -||
1951|090|S|   Call your doctor for medical advice about side effects. You||
1951|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1951|092|S|www.fda.gov/medwatch.||
1951|093|S|   In Canada - Call your doctor for medical advice about side||
1951|094|S|effects. You may report side effects to Health Canada at||
1951|095|S|1-866-234-2345.||
1951|096|B|||
1951|097|P|PRECAUTIONS:  Before using mogamulizumab, tell your doctor or||
1951|098|P|pharmacist if you are allergic to it; or if you have any other||
1951|099|P|allergies. This product may contain inactive ingredients, which||
1951|100|P|can cause allergic reactions or other problems. Talk to your||
1951|101|P|pharmacist for more details.||
1951|102|P|   Before using this medication, tell your doctor or pharmacist||
1951|103|P|your medical history, especially of: diabetes, current/recent||
1951|104|P|infections, liver problems (including hepatitis B infection),||
1951|105|P|overactive immune system disorder (such as rheumatoid arthritis,||
1951|106|P|lupus).||
1951|107|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1951|108|P|can make you more dizzy. Do not drive, use machinery, or do||
1951|109|P|anything that needs alertness until you can do it safely. Limit||
1951|110|P|alcoholic beverages. Talk to your doctor if you are using||
1951|111|P|marijuana (cannabis).||
1951|112|P|   This medication can make you more likely to get infections or||
1951|113|P|may make current infections worse. Stay away from anyone who has||
1951|114|P|an infection that may easily spread (such as chickenpox,||
1951|115|P|COVID-19, measles, flu). Talk to your doctor if you have been||
1951|116|P|exposed to an infection or for more details.||
1951|117|P|   Tell your health care professional that you are using||
1951|118|P|mogamulizumab before having any immunizations/vaccinations. Avoid||
1951|119|P|contact with people who have recently received live vaccines||
1951|120|P|(such as flu vaccine inhaled through the nose).||
1951|121|P|   To lower the chance of getting cut, bruised, or injured, use||
1951|122|P|caution with sharp objects like razors and nail cutters, and||
1951|123|P|avoid activities such as contact sports.||
1951|124|P|   Before having surgery, tell your doctor or dentist about all||
1951|125|P|the products you use (including prescription drugs,||
1951|126|P|nonprescription drugs, and herbal products). You may have a||
1951|127|P|higher risk of serious reactions after certain procedures (such||
1951|128|P|as stem cell transplant). Talk to your doctor for details.||
1951|129|P|   Tell your doctor if you are pregnant or plan to become||
1951|130|P|pregnant. You should not become pregnant while using||
1951|131|P|mogamulizumab. Your doctor should order a pregnancy test before||
1951|132|P|you start this medication. Ask about reliable forms of birth||
1951|133|P|control while using this medication and for at least 3 months||
1951|134|P|after the last dose. If you become pregnant, talk to your doctor||
1951|135|P|right away about the risks and benefits of this medication.||
1951|136|P|   It is unknown if this drug passes into breast milk. Consult||
1951|137|P|your doctor before breastfeeding.||
1951|138|B|||
1951|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1951|140|I|medications work or increase your risk for serious side effects.||
1951|141|I|This document does not contain all possible drug interactions.||
1951|142|I|Keep a list of all the products you use (including||
1951|143|I|prescription/nonprescription drugs and herbal products) and share||
1951|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
1951|145|I|the dosage of any medicines without your doctor's approval.||
1951|146|B|||
1951|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1951|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1951|149|O|poison control center right away. US residents can call||
1951|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1951|151|B|||
1951|152|N|NOTES:  Lab and/or medical tests may be done while you are using||
1951|153|N|this medication. Keep all medical and lab appointments.||
1951|154|B|||
1951|155|D|MISSED DOSE:  It is important to get each dose of this medication||
1951|156|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1951|157|D|right away for a new dosing schedule.||
1951|158|B|||
1951|159|R|STORAGE:  Not applicable. This medication is given in a hospital||
1951|160|R|or clinic or doctor's office and will not be stored at home.||
1951|161|B|||
1951|162|M|MEDICAL ALERT:  Your condition can cause complications in a||
1951|163|M|medical emergency. For information about enrolling in MedicAlert,||
1951|164|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1951|165|B|||
1951|166|A|Information last revised April 2025.||
1951|167|A|Copyright(c) 2025 First Databank, Inc.||
1951|168|B|||
1952|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1952|002|Z|does NOT have all possible information about this product. This||
1952|003|Z|information does not assure that this product is safe, effective,||
1952|004|Z|or appropriate for you. This information is not individual||
1952|005|Z|medical advice and does not substitute for the advice of your||
1952|006|Z|health care professional. Always ask your health care||
1952|007|Z|professional for complete information about this product and your||
1952|008|Z|specific health needs.||
1952|009|B|||
1952|010|T|LUSUTROMBOPAG - ORAL||
1952|011|F|(LOO-soo-TROM-boe-pag)||
1952|012|B|||
1952|013|C|COMMON BRAND NAME(S): Mulpleta||
1952|014|B|||
1952|015|U|USES:  This medication is used by people with chronic liver||
1952|016|U|disease and a certain blood disorder (low platelet count) who are||
1952|017|U|scheduled to have a medical or dental procedure. Having a low||
1952|018|U|platelet count increases the risk of too much bleeding during||
1952|019|U|certain procedures. This medication increases the production of||
1952|020|U|platelets by your body to help prevent too much bleeding from the||
1952|021|U|procedure.||
1952|022|B|||
1952|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1952|024|H|from your pharmacist before you start taking lusutrombopag and||
1952|025|H|each time you get a refill. If you have any questions, ask your||
1952|026|H|doctor or pharmacist.||
1952|027|H|   Take this medication by mouth with or without food as directed||
1952|028|H|by your doctor, usually once daily for 7 days in a row. Your||
1952|029|H|doctor will tell you how much to take and when to start taking it||
1952|030|H|(usually 8 to 14 days before your procedure). Carefully follow||
1952|031|H|your doctor's directions. Your doctor will check your platelet||
1952|032|H|count before you start taking this medication and before your||
1952|033|H|procedure.||
1952|034|H|   Use this medication regularly to get the most benefit from it.||
1952|035|H|To help you remember, take it at the same time each day.||
1952|036|B|||
1952|037|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1952|038|S|because your doctor has judged that the benefit to you is greater||
1952|039|S|than the risk of side effects. Many people using this medication||
1952|040|S|do not have serious side effects.||
1952|041|S|   This medication may rarely cause serious problems from blood||
1952|042|S|clots (such as heart attack, stroke, blood clots in the lungs or||
1952|043|S|legs). You may be at increased risk for blood clots if you have a||
1952|044|S|history of blood clots, certain inherited blood clotting||
1952|045|S|disorders, or if you are immobile (such as on very long plane||
1952|046|S|flights or being bedridden). If you use estrogen-containing||
1952|047|S|products, these may also increase your risk. Before using this||
1952|048|S|medication, if you have any of these conditions report them to||
1952|049|S|your doctor or pharmacist. Get medical help right away if any of||
1952|050|S|these side effects occur: shortness of breath/rapid breathing,||
1952|051|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1952|052|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1952|053|S|sudden/severe headaches, trouble speaking, weakness on one side||
1952|054|S|of the body, sudden vision changes, stomach/abdominal pain or||
1952|055|S|tenderness.||
1952|056|S|   A very serious allergic reaction to this drug is rare.||
1952|057|S|However, get medical help right away if you notice any symptoms||
1952|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1952|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1952|060|S|breathing.||
1952|061|S|   This is not a complete list of possible side effects. If you||
1952|062|S|notice other effects not listed above, contact your doctor or||
1952|063|S|pharmacist.||
1952|064|S|   In the US -||
1952|065|S|   Call your doctor for medical advice about side effects. You||
1952|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1952|067|S|www.fda.gov/medwatch.||
1952|068|S|   In Canada - Call your doctor for medical advice about side||
1952|069|S|effects. You may report side effects to Health Canada at||
1952|070|S|1-866-234-2345.||
1952|071|B|||
1952|072|P|PRECAUTIONS:  Before taking lusutrombopag, tell your doctor or||
1952|073|P|pharmacist if you are allergic to it; or if you have any other||
1952|074|P|allergies. This product may contain inactive ingredients, which||
1952|075|P|can cause allergic reactions or other problems. Talk to your||
1952|076|P|pharmacist for more details.||
1952|077|P|   Before using this medication, tell your doctor or pharmacist||
1952|078|P|your medical history, especially of: blood clotting disorders||
1952|079|P|(such as protein C or protein S deficiency, antithrombin||
1952|080|P|deficiency, Factor V Leiden).||
1952|081|P|   Before having surgery, tell your doctor or dentist about all||
1952|082|P|the products you use (including prescription drugs,||
1952|083|P|nonprescription drugs, and herbal products).||
1952|084|P|   During pregnancy, this medication should be used only when||
1952|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
1952|086|P|   It is unknown if this medication passes into breast milk.||
1952|087|P|Because of the possible risk to the infant, breastfeeding is not||
1952|088|P|recommended while using this medication and for at least 28 days||
1952|089|P|after the last dose. Consult your doctor before breastfeeding.||
1952|090|B|||
1952|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1952|092|I|medications work or increase your risk for serious side effects.||
1952|093|I|This document does not contain all possible drug interactions.||
1952|094|I|Keep a list of all the products you use (including||
1952|095|I|prescription/nonprescription drugs and herbal products) and share||
1952|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
1952|097|I|the dosage of any medicines without your doctor's approval.||
1952|098|B|||
1952|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1952|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1952|101|O|poison control center right away. US residents can call||
1952|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1952|103|B|||
1952|104|N|NOTES:  Do not share this medication with others.||
1952|105|N|   Lab and/or medical tests (such as platelets, blood mineral||
1952|106|N|levels) must be done before you start and while you are taking||
1952|107|N|this medication. Keep all medical and lab appointments.||
1952|108|B|||
1952|109|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1952|110|D|remember. If you don't remember until the next day, skip the||
1952|111|D|missed dose. Take your next dose at the regular time. Do not||
1952|112|D|double the dose to catch up.||
1952|113|B|||
1952|114|R|STORAGE:  Store in the original package at room temperature away||
1952|115|R|from light and moisture. Do not store in the bathroom. Keep all||
1952|116|R|medications away from children and pets.||
1952|117|R|   Do not flush medications down the toilet or pour them into a||
1952|118|R|drain unless instructed to do so. Properly discard this product||
1952|119|R|when it is expired or no longer needed. Consult your pharmacist||
1952|120|R|or local waste disposal company.||
1952|121|B|||
1952|122|M|MEDICAL ALERT:  Your condition can cause complications in a||
1952|123|M|medical emergency. For information about enrolling in MedicAlert,||
1952|124|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1952|125|B|||
1952|126|A|Information last revised July 2024.||
1952|127|A|Copyright(c) 2025 First Databank, Inc.||
1952|128|B|||
1953|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1953|002|Z|does NOT have all possible information about this product. This||
1953|003|Z|information does not assure that this product is safe, effective,||
1953|004|Z|or appropriate for you. This information is not individual||
1953|005|Z|medical advice and does not substitute for the advice of your||
1953|006|Z|health care professional. Always ask your health care||
1953|007|Z|professional for complete information about this product and your||
1953|008|Z|specific health needs.||
1953|009|B|||
1953|010|T|PEG/ELECTROLYTE (32 OUNCES) - ORAL||
1953|011|F|(PEG/ih-LECK-troh-lite)||
1953|012|B|||
1953|013|U|USES:  PEG (polyethylene glycol) with electrolyte is used to||
1953|014|U|clean out the intestines before certain bowel exam procedures||
1953|015|U|such as colonoscopy. It is a laxative that works by drawing large||
1953|016|U|amounts of water into the colon. This results in watery bowel||
1953|017|U|movements. Clearing stool from the intestines helps your doctor||
1953|018|U|to better examine the intestines during your procedure.||
1953|019|B|||
1953|020|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1953|021|H|provided by your pharmacist before you start taking this||
1953|022|H|medication and each time you get a new prescription for it. If||
1953|023|H|you have any questions, ask your doctor or pharmacist.||
1953|024|H|   Follow any special diet instructions provided by your doctor.||
1953|025|H|Be sure to ask your doctor which foods/liquids you may eat or||
1953|026|H|drink before the procedure; otherwise the exam may have to be||
1953|027|H|repeated. After you start drinking this medication, do not eat||
1953|028|H|any solid food until after your procedure is done. To prevent||
1953|029|H|becoming dehydrated, drink plenty of clear liquids as directed by||
1953|030|H|your doctor.||
1953|031|H|   This product comes with 2 doses. You may be instructed to take||
1953|032|H|the first dose the evening before the procedure and the second||
1953|033|H|dose the morning of the procedure (about 12 hours apart) or to||
1953|034|H|take both doses (at least 2 hours apart) the morning of the||
1953|035|H|procedure. You should finish your second dose of the medication||
1953|036|H|and any other clear liquids at least 2 hours before your||
1953|037|H|procedure. Follow your doctor's instructions carefully.||
1953|038|H|   Before using this product, mix each dose with water in the||
1953|039|H|mixing container as directed. Read and follow all directions||
1953|040|H|provided by the manufacturer to mix this product. Drink all the||
1953|041|H|liquid in the mixing container over 30 minutes. After finishing||
1953|042|H|your dose, fill the mixing container with clear liquid and drink||
1953|043|H|all the liquid over another 30 minutes. Drink additional clear||
1953|044|H|liquid as directed by your doctor.||
1953|045|H|   This product may cause certain liquid thickeners (starch-based||
1953|046|H|products) to not work well, which may increase the risk of||
1953|047|H|choking. If you are using liquid thickeners with this product,||
1953|048|H|talk to your pharmacist to select a liquid thickener which will||
1953|049|H|not interact with this product.||
1953|050|H|   Watery bowel movements usually begin about 1 hour after you||
1953|051|H|start to drink the mixed liquid. The bowel movements can be very||
1953|052|H|large and watery.||
1953|053|H|   Do not take any other medications by mouth within 1 hour of||
1953|054|H|starting to drink the mixed liquid because your body may not||
1953|055|H|absorb the other medications. Ask your doctor or pharmacist if||
1953|056|H|you are not sure when to take your other medications.||
1953|057|B|||
1953|058|S|SIDE EFFECTS:  Very watery bowel movements are expected with this||
1953|059|S|medication. Nausea, bloating, or feelings of fullness in the||
1953|060|S|stomach/abdomen are very common. Stomach/abdominal cramps and||
1953|061|S|vomiting occur less often. If any of these effects last or get||
1953|062|S|worse, tell your doctor or pharmacist promptly.||
1953|063|S|   If severe bloating or abdominal pain occurs, drink the mixture||
1953|064|S|more slowly or briefly stop drinking the mixture until the||
1953|065|S|symptoms get better.||
1953|066|S|   Remember that this medication has been prescribed because your||
1953|067|S|doctor has judged that the benefit to you is greater than the||
1953|068|S|risk of side effects. Many people using this medication do not||
1953|069|S|have serious side effects.||
1953|070|S|   Tell your doctor right away if you have any serious side||
1953|071|S|effects, including: vomit that is bloody or looks like coffee||
1953|072|S|grounds, chest pain, fast/slow/irregular heartbeat, dizziness,||
1953|073|S|fainting, seizures, sudden shortness of breath, signs of kidney||
1953|074|S|problems (such as change in the amount of urine),||
1953|075|S|stomach/abdominal pain that is severe or doesn't go away, bloody||
1953|076|S|stools, rectal bleeding.||
1953|077|S|   A very serious allergic reaction to this drug is rare.||
1953|078|S|However, get medical help right away if you notice any symptoms||
1953|079|S|of a serious allergic reaction, including: rash, itching/swelling||
1953|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1953|081|S|breathing.||
1953|082|S|   This is not a complete list of possible side effects. If you||
1953|083|S|notice other effects not listed above, contact your doctor or||
1953|084|S|pharmacist.||
1953|085|S|   In the US -||
1953|086|S|   Call your doctor for medical advice about side effects. You||
1953|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1953|088|S|www.fda.gov/medwatch.||
1953|089|S|   In Canada - Call your doctor for medical advice about side||
1953|090|S|effects. You may report side effects to Health Canada at||
1953|091|S|1-866-234-2345.||
1953|092|B|||
1953|093|P|PRECAUTIONS:  Before taking PEG with electrolyte, tell your||
1953|094|P|doctor or pharmacist if you are allergic to it; or if you have||
1953|095|P|any other allergies. This product may contain inactive||
1953|096|P|ingredients, which can cause allergic reactions or other||
1953|097|P|problems. Talk to your pharmacist for more details.||
1953|098|P|   Before using this medication, tell your doctor or pharmacist||
1953|099|P|your medical history, especially of: stomach/intestinal problems||
1953|100|P|(such as hole in the intestines, ulcers, blockage, toxic colitis,||
1953|101|P|toxic megacolon, ulcerative colitis, ileus), swallowing problems,||
1953|102|P|certain metabolic problem (G6PD deficiency), kidney problems,||
1953|103|P|heart problems (such as irregular heartbeat), seizures.||
1953|104|P|   This medication may contain aspartame. If you have||
1953|105|P|phenylketonuria (PKU) or any other condition that requires you to||
1953|106|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
1953|107|P|doctor or pharmacist about using this medication safely.||
1953|108|P|   Older adults may be more sensitive to the side effects of this||
1953|109|P|drug, especially dehydration and loss of salts in the blood (such||
1953|110|P|as potassium, sodium).||
1953|111|P|   During pregnancy, this medication should be used only when||
1953|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
1953|113|P|   It is unknown if this drug passes into breast milk. Consult||
1953|114|P|your doctor before breastfeeding.||
1953|115|B|||
1953|116|I|DRUG INTERACTIONS:  See also How to Use section.||
1953|117|I|   Drug interactions may change how your medications work or||
1953|118|I|increase your risk for serious side effects. This document does||
1953|119|I|not contain all possible drug interactions. Keep a list of all||
1953|120|I|the products you use (including prescription/nonprescription||
1953|121|I|drugs and herbal products) and share it with your doctor and||
1953|122|I|pharmacist. Do not start, stop, or change the dosage of any||
1953|123|I|medicines without your doctor's approval.||
1953|124|I|   Some products that may interact with this drug are: laxatives||
1953|125|I|(such as bisacodyl).||
1953|126|B|||
1953|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1953|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1953|129|O|poison control center right away. US residents can call||
1953|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1953|131|B|||
1953|132|N|NOTES:  Do not share this medication with others.||
1953|133|N|   Lab and/or medical tests (such as blood mineral levels) should||
1953|134|N|be done before and while you are using this medication. Keep all||
1953|135|N|medical and lab appointments. Consult your doctor for more||
1953|136|N|details.||
1953|137|B|||
1953|138|D|MISSED DOSE:  It is important to take each dose of this||
1953|139|D|medication as scheduled. If you miss a dose, ask your doctor or||
1953|140|D|pharmacist right away for a new dosing schedule. Do not double||
1953|141|D|the dose to catch up.||
1953|142|B|||
1953|143|R|STORAGE:  Store the powder or mixed solution at room temperature||
1953|144|R|or in the refrigerator. Do not store in the bathroom. The mixed||
1953|145|R|solution should be used within 24 hours after mixing. Discard any||
1953|146|R|unused mixture. Keep all medications away from children and pets.||
1953|147|R|   Do not flush medications down the toilet or pour them into a||
1953|148|R|drain unless instructed to do so. Properly discard this product||
1953|149|R|when it is expired or no longer needed. Consult your pharmacist||
1953|150|R|or local waste disposal company.||
1953|151|B|||
1953|152|A|Information last revised May 2024.||
1953|153|A|Copyright(c) 2025 First Databank, Inc.||
1953|154|B|||
1954|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1954|002|Z|does NOT have all possible information about this product. This||
1954|003|Z|information does not assure that this product is safe, effective,||
1954|004|Z|or appropriate for you. This information is not individual||
1954|005|Z|medical advice and does not substitute for the advice of your||
1954|006|Z|health care professional. Always ask your health care||
1954|007|Z|professional for complete information about this product and your||
1954|008|Z|specific health needs.||
1954|009|B|||
1954|010|T|LANADELUMAB - INJECTION||
1954|011|F|(LAN-a-DEL-ue-mab)||
1954|012|B|||
1954|013|C|COMMON BRAND NAME(S): Takhzyro||
1954|014|B|||
1954|015|U|USES:  This medication is used to help prevent severe swelling||
1954|016|U|attacks due to a certain inherited immune disease (hereditary||
1954|017|U|angioedema-HAE). Lanadelumab works by binding to a natural||
1954|018|U|substance made by the body (kallikrein) and blocking its effect.||
1954|019|U|This blocking effect lowers the amount of another natural||
1954|020|U|substance (bradykinin) that causes symptoms during an attack of||
1954|021|U|HAE. Lanadelumab may help decrease symptoms such as abdominal||
1954|022|U|pain/cramps, diarrhea, vomiting, or rapid swelling and pain of||
1954|023|U|the hands, feet, limbs, face, tongue, or throat.||
1954|024|B|||
1954|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
1954|026|H|Instructions for Use if available from your pharmacist before you||
1954|027|H|start using lanadelumab and each time you get a refill. If you||
1954|028|H|have any questions, ask your doctor or pharmacist.||
1954|029|H|   Inject this medication under the skin as directed by your||
1954|030|H|doctor, usually once every 2 or 4 weeks. The injection is given||
1954|031|H|in the thigh, abdomen, or upper arm. The dosage and treatment||
1954|032|H|schedule are based on your medical condition, age, and response||
1954|033|H|to treatment.||
1954|034|H|   If you are using this medication at home, learn all||
1954|035|H|preparation and usage instructions from your health care||
1954|036|H|professional and the product package. Take the medication out of||
1954|037|H|the refrigerator at least 15 minutes before you inject it to||
1954|038|H|allow it to reach room temperature. Do not warm up this||
1954|039|H|medication any other way (for example, do not heat it in the||
1954|040|H|microwave or place it in hot water). Do not shake the medication.||
1954|041|H|Before using, check this product for particles or discoloration.||
1954|042|H|If either is present, do not use the liquid. Before injecting||
1954|043|H|each dose, clean the skin you are going to inject into (the||
1954|044|H|injection site) with rubbing alcohol. Change the injection site||
1954|045|H|each time to lessen injury under the skin. Do not inject into||
1954|046|H|skin that is bruised, swollen, tender, painful, or that has||
1954|047|H|scars. To lessen bruising, do not rub the injection site after a||
1954|048|H|shot. Learn how to store and discard medical supplies safely.||
1954|049|H|   Use this medication regularly to get the most benefit from it.||
1954|050|H|To help you remember, mark your calendar with a reminder.||
1954|051|H|   Tell your doctor if your condition does not get better or if||
1954|052|H|it gets worse.||
1954|053|B|||
1954|054|S|SIDE EFFECTS:  Pain, bruising, itching, redness, or swelling at||
1954|055|S|the injection site may occur. Cold-like symptoms (such as||
1954|056|S|runny/stuffy nose), headache, muscle pain, dizziness, and||
1954|057|S|diarrhea may also occur. If any of these effects last or get||
1954|058|S|worse, tell your doctor or pharmacist promptly.||
1954|059|S|   Remember that this medication has been prescribed because your||
1954|060|S|doctor has judged that the benefit to you is greater than the||
1954|061|S|risk of side effects. Many people using this medication do not||
1954|062|S|have serious side effects.||
1954|063|S|   A very serious allergic reaction to this drug is rare.||
1954|064|S|However, get medical help right away if you notice any symptoms||
1954|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1954|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1954|067|S|breathing.||
1954|068|S|   This is not a complete list of possible side effects. If you||
1954|069|S|notice other effects not listed above, contact your doctor or||
1954|070|S|pharmacist.||
1954|071|S|   In the US -||
1954|072|S|   Call your doctor for medical advice about side effects. You||
1954|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1954|074|S|www.fda.gov/medwatch.||
1954|075|S|   In Canada - Call your doctor for medical advice about side||
1954|076|S|effects. You may report side effects to Health Canada at||
1954|077|S|1-866-234-2345.||
1954|078|B|||
1954|079|P|PRECAUTIONS:  Before using lanadelumab, tell your doctor or||
1954|080|P|pharmacist if you are allergic to it; or if you have any other||
1954|081|P|allergies. This product may contain inactive ingredients, which||
1954|082|P|can cause allergic reactions or other problems. Talk to your||
1954|083|P|pharmacist for more details.||
1954|084|P|   Before using this medication, tell your doctor or pharmacist||
1954|085|P|your medical history.||
1954|086|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1954|087|P|can make you more dizzy. Do not drive, use machinery, or do||
1954|088|P|anything that needs alertness until you can do it safely. Limit||
1954|089|P|alcoholic beverages. Talk to your doctor if you are using||
1954|090|P|marijuana (cannabis).||
1954|091|P|   Before having surgery, tell your doctor or dentist about all||
1954|092|P|the products you use (including prescription drugs,||
1954|093|P|nonprescription drugs, and herbal products).||
1954|094|P|   During pregnancy, this medication should be used only when||
1954|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
1954|096|P|   It is unknown if this drug passes into breast milk. Consult||
1954|097|P|your doctor before breastfeeding.||
1954|098|B|||
1954|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1954|100|I|medications work or increase your risk for serious side effects.||
1954|101|I|This document does not contain all possible drug interactions.||
1954|102|I|Keep a list of all the products you use (including||
1954|103|I|prescription/nonprescription drugs and herbal products) and share||
1954|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
1954|105|I|the dosage of any medicines without your doctor's approval.||
1954|106|I|   This medication may interfere with certain lab tests (such as||
1954|107|I|blood clotting tests), possibly causing false test results. Make||
1954|108|I|sure lab personnel and all your doctors know you use this drug.||
1954|109|B|||
1954|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1954|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1954|112|O|poison control center right away. US residents can call||
1954|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1954|114|B|||
1954|115|N|NOTES:  Do not share this medication with others.||
1954|116|N|   Lab and/or medical tests may be done while you are using this||
1954|117|N|medication. Keep all medical and lab appointments.||
1954|118|B|||
1954|119|D|MISSED DOSE:  It is important to get each dose of this medication||
1954|120|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1954|121|D|right away for a new dosing schedule.||
1954|122|B|||
1954|123|R|STORAGE:  Store in the refrigerator. Do not freeze or shake. Keep||
1954|124|R|the medication in the original package to protect from light.||
1954|125|R|Keep all medications away from children and pets.||
1954|126|R|   Do not flush medications down the toilet or pour them into a||
1954|127|R|drain unless instructed to do so. Properly discard this product||
1954|128|R|when it is expired or no longer needed. Consult your pharmacist||
1954|129|R|or local waste disposal company.||
1954|130|B|||
1954|131|A|Information last revised October 2024.||
1954|132|A|Copyright(c) 2025 First Databank, Inc.||
1954|133|B|||
1955|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1955|002|Z|does NOT have all possible information about this product. This||
1955|003|Z|information does not assure that this product is safe, effective,||
1955|004|Z|or appropriate for you. This information is not individual||
1955|005|Z|medical advice and does not substitute for the advice of your||
1955|006|Z|health care professional. Always ask your health care||
1955|007|Z|professional for complete information about this product and your||
1955|008|Z|specific health needs.||
1955|009|B|||
1955|010|T|IOBENGUANE I 131 - INJECTION||
1955|011|F|(EYE-oh-BEN-gwane)||
1955|012|B|||
1955|013|C|COMMON BRAND NAME(S): Azedra||
1955|014|B|||
1955|015|U|USES:  This medication is used to treat certain cancers||
1955|016|U|(pheochromocytoma, paraganglioma). Iobenguane I 131 is a||
1955|017|U|radioactive drug. It works by building up in certain cancer cells||
1955|018|U|and causing them to die.||
1955|019|B|||
1955|020|H|HOW TO USE:  This medication is given by injection into a vein by||
1955|021|H|a health care professional. It is given as directed by your||
1955|022|H|doctor, usually 2 doses given at least 90 days apart.||
1955|023|H|   The dosage is based on your medical condition, weight, lab||
1955|024|H|tests, and response to treatment.||
1955|025|H|   To decrease the risk of side effects, your doctor will||
1955|026|H|prescribe other medications (such as drugs to prevent nausea) for||
1955|027|H|you to use before each injection. Your doctor will also prescribe||
1955|028|H|a drug to help protect your thyroid gland, starting 24 hours||
1955|029|H|before and continuing for 10 days after each dose of this||
1955|030|H|medication. To lessen damage to your bladder, drink at least 8||
1955|031|H|glasses (68 ounces/2 liters) of liquid daily, starting at least 1||
1955|032|H|day before and continuing for one week after each dose. Carefully||
1955|033|H|follow all of your doctor's directions.||
1955|034|B|||
1955|035|S|SIDE EFFECTS:  Dizziness, tiredness, headache, nausea, vomiting,||
1955|036|S|diarrhea/constipation, abdominal pain, change in how food tastes,||
1955|037|S|dry mouth, throat pain, or loss of appetite may occur. Nausea and||
1955|038|S|vomiting can be severe. In some cases, your doctor may prescribe||
1955|039|S|medication to prevent or relieve nausea and vomiting. Eating||
1955|040|S|several small meals, not eating before treatment, or limiting||
1955|041|S|activity may help lessen some of these effects. If any of these||
1955|042|S|effects last or get worse, tell your doctor or pharmacist||
1955|043|S|promptly.||
1955|044|S|   To reduce the risk of dizziness and lightheadedness, get up||
1955|045|S|slowly when rising from a sitting or lying position.||
1955|046|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
1955|047|S|chips, chew (sugarless) gum, drink water, or use a saliva||
1955|048|S|substitute.||
1955|049|S|   Temporary hair loss may occur. Normal hair growth should||
1955|050|S|return after treatment has ended.||
1955|051|S|   People using this medication may have serious side effects.||
1955|052|S|However, you have been prescribed this drug because your doctor||
1955|053|S|has judged that the benefit to you is greater than the risk of||
1955|054|S|side effects. Careful monitoring by your doctor may decrease your||
1955|055|S|risk.||
1955|056|S|   This medication may raise your blood pressure. Check your||
1955|057|S|blood pressure regularly and tell your doctor if the results are||
1955|058|S|high.||
1955|059|S|   Tell your doctor right away if you have any serious side||
1955|060|S|effects, including: easy bruising/bleeding, signs of kidney||
1955|061|S|damage (such as change in amount of urine).||
1955|062|S|   This medication may lower your ability to fight infections.||
1955|063|S|This may make you more likely to get a serious (rarely fatal)||
1955|064|S|infection or make any infection you have worse. Tell your doctor||
1955|065|S|right away if you have any signs of infection (such as sore||
1955|066|S|throat that doesn't go away, fever, chills).||
1955|067|S|   A very serious allergic reaction to this drug is rare.||
1955|068|S|However, get medical help right away if you notice any symptoms||
1955|069|S|of a serious allergic reaction, including: rash, itching/swelling||
1955|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1955|071|S|breathing.||
1955|072|S|   This is not a complete list of possible side effects. If you||
1955|073|S|notice other effects not listed above, contact your doctor or||
1955|074|S|pharmacist.||
1955|075|S|   In the US -||
1955|076|S|   Call your doctor for medical advice about side effects. You||
1955|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1955|078|S|www.fda.gov/medwatch.||
1955|079|S|   In Canada - Call your doctor for medical advice about side||
1955|080|S|effects. You may report side effects to Health Canada at||
1955|081|S|1-866-234-2345.||
1955|082|B|||
1955|083|P|PRECAUTIONS:  Before using iobenguane I 131, tell your doctor or||
1955|084|P|pharmacist if you are allergic to it; or if you have any other||
1955|085|P|allergies. This product may contain inactive ingredients, which||
1955|086|P|can cause allergic reactions or other problems. Talk to your||
1955|087|P|pharmacist for more details.||
1955|088|P|   Before using this medication, tell your doctor or pharmacist||
1955|089|P|your medical history, especially of: kidney problems, thyroid||
1955|090|P|disease, high blood pressure.||
1955|091|P|   This medication can make you more likely to get infections or||
1955|092|P|may make current infections worse. Stay away from anyone who has||
1955|093|P|an infection that may easily spread (such as chickenpox,||
1955|094|P|COVID-19, measles, flu). Talk to your doctor if you have been||
1955|095|P|exposed to an infection or for more details.||
1955|096|P|   Tell your health care professional that you are using||
1955|097|P|iobenguane I 131 before having any immunizations/vaccinations.||
1955|098|P|Avoid contact with people who have recently received live||
1955|099|P|vaccines (such as flu vaccine inhaled through the nose).||
1955|100|P|   To lower the chance of getting cut, bruised, or injured, use||
1955|101|P|caution with sharp objects like razors and nail cutters, and||
1955|102|P|avoid activities such as contact sports.||
1955|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1955|104|P|can make you more dizzy. Do not drive, use machinery, or do||
1955|105|P|anything that needs alertness until you can do it safely. Limit||
1955|106|P|alcoholic beverages. Talk to your doctor if you are using||
1955|107|P|marijuana (cannabis).||
1955|108|P|   This medication may increase your risk for other cancers (such||
1955|109|P|as myelodysplastic syndrome, leukemia). Talk to your doctor for||
1955|110|P|details.||
1955|111|P|   Before having surgery, tell your doctor or dentist about all||
1955|112|P|the products you use (including prescription drugs,||
1955|113|P|nonprescription drugs, and herbal products).||
1955|114|P|   Children may be at greater risk for side effects of this drug.||
1955|115|P|   This medication may affect the ability to have children. Talk||
1955|116|P|to your doctor for details.||
1955|117|P|   Tell your doctor if you are pregnant or plan to become||
1955|118|P|pregnant. You should not become pregnant while using this||
1955|119|P|medication. Iobenguane I 131 may harm an unborn baby. Your doctor||
1955|120|P|should order a pregnancy test before you start this medication.||
1955|121|P|Women using this medication should ask about reliable forms of||
1955|122|P|birth control during treatment and for 7 months after the last||
1955|123|P|dose. Men using this medication should ask about reliable forms||
1955|124|P|of birth control during treatment and for 4 months after the last||
1955|125|P|dose. If you or your partner becomes pregnant, talk to your||
1955|126|P|doctor right away about the risks and benefits of this||
1955|127|P|medication.||
1955|128|P|   It is unknown if this drug passes into breast milk. Because of||
1955|129|P|the possible risk to the infant, breastfeeding is not recommended||
1955|130|P|while using this drug and for 80 days after the last dose.||
1955|131|P|Consult your doctor before breastfeeding.||
1955|132|B|||
1955|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1955|134|I|medications work or increase your risk for serious side effects.||
1955|135|I|This document does not contain all possible drug interactions.||
1955|136|I|Keep a list of all the products you use (including||
1955|137|I|prescription/nonprescription drugs and herbal products) and share||
1955|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
1955|139|I|the dosage of any medicines without your doctor's approval.||
1955|140|B|||
1955|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1955|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1955|143|O|poison control center right away. US residents can call||
1955|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1955|145|B|||
1955|146|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1955|147|N|kidney/thyroid function, blood pressure) should be done while you||
1955|148|N|are using this medication. Keep all medical and lab appointments.||
1955|149|B|||
1955|150|D|MISSED DOSE:  It is important to get each dose of this medication||
1955|151|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1955|152|D|right away for a new dosing schedule. Do not double the dose to||
1955|153|D|catch up.||
1955|154|B|||
1955|155|R|STORAGE:  Not applicable. This medication is given in a hospital||
1955|156|R|or clinic or doctor's office and will not be stored at home.||
1955|157|B|||
1955|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
1955|159|M|medical emergency. For information about enrolling in MedicAlert,||
1955|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1955|161|B|||
1955|162|A|Information last revised April 2025.||
1955|163|A|Copyright(c) 2025 First Databank, Inc.||
1955|164|B|||
1957|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1957|002|Z|does NOT have all possible information about this product. This||
1957|003|Z|information does not assure that this product is safe, effective,||
1957|004|Z|or appropriate for you. This information is not individual||
1957|005|Z|medical advice and does not substitute for the advice of your||
1957|006|Z|health care professional. Always ask your health care||
1957|007|Z|professional for complete information about this product and your||
1957|008|Z|specific health needs.||
1957|009|B|||
1957|010|T|GLYCOPYRRONIUM CLOTH - TOPICAL||
1957|011|F|(GLYE-koe-pir-OH-nee-um)||
1957|012|B|||
1957|013|C|COMMON BRAND NAME(S): Qbrexza||
1957|014|B|||
1957|015|U|USES:  This form of glycopyrronium is used to treat excessive||
1957|016|U|sweating from your underarms. The drug solution is on a||
1957|017|U|pre-moistened cloth for application to the skin. It works on the||
1957|018|U|sweat glands to reduce sweating. Glycopyrronium belongs to a||
1957|019|U|class of drugs known as anticholinergics.||
1957|020|B|||
1957|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1957|022|H|from your pharmacist before you start using this product and each||
1957|023|H|time you get a refill. If you have any questions, ask your doctor||
1957|024|H|or pharmacist.||
1957|025|H|   Use as directed by your doctor, usually once daily. Apply only||
1957|026|H|to clean, dry skin of your underarms. Do not apply to broken||
1957|027|H|skin. To use, carefully open one pouch and remove the cloth.||
1957|028|H|Unfold the cloth and apply by wiping once across one underarm.||
1957|029|H|Using the same cloth, wipe once across the other underarm. Do not||
1957|030|H|cover the treated area(s) with a plastic dressing/bandage. Do not||
1957|031|H|save the cloth to use again. Throw away the used cloth in the||
1957|032|H|trash. To avoid accidentally getting this medication in your eyes||
1957|033|H|or other areas, wash your hands right away after using the cloth.||
1957|034|H|   Use this product regularly to get the most benefit from it. To||
1957|035|H|help you remember, use it at the same time each day.||
1957|036|H|   Tell your doctor if your condition does not get better or if||
1957|037|H|it gets worse.||
1957|038|B|||
1957|039|S|SIDE EFFECTS:  Redness, burning/stinging, or itching at the||
1957|040|S|application site may occur. Dry mouth/nose/throat, dry skin,||
1957|041|S|headache, or blurred vision may also occur. If any of these||
1957|042|S|effects last or get worse, tell your doctor or pharmacist||
1957|043|S|promptly.||
1957|044|S|   Remember that this medication has been prescribed because your||
1957|045|S|doctor has judged that the benefit to you is greater than the||
1957|046|S|risk of side effects. Many people using this medication do not||
1957|047|S|have serious side effects.||
1957|048|S|   Tell your doctor right away if you have any serious side||
1957|049|S|effects, including: trouble urinating (such as weak stream or||
1957|050|S|drips, urinating very often, full bladder).||
1957|051|S|   A very serious allergic reaction to this drug is rare.||
1957|052|S|However, get medical help right away if you notice any symptoms||
1957|053|S|of a serious allergic reaction, including: rash, itching/swelling||
1957|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1957|055|S|breathing.||
1957|056|S|   This is not a complete list of possible side effects. If you||
1957|057|S|notice other effects not listed above, contact your doctor or||
1957|058|S|pharmacist.||
1957|059|S|   In the US -||
1957|060|S|   Call your doctor for medical advice about side effects. You||
1957|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1957|062|S|www.fda.gov/medwatch.||
1957|063|S|   In Canada - Call your doctor for medical advice about side||
1957|064|S|effects. You may report side effects to Health Canada at||
1957|065|S|1-866-234-2345.||
1957|066|B|||
1957|067|P|PRECAUTIONS:  Before using glycopyrronium, tell your doctor or||
1957|068|P|pharmacist if you are allergic to it; or if you have any other||
1957|069|P|allergies. This product may contain inactive ingredients, which||
1957|070|P|can cause allergic reactions or other problems. Talk to your||
1957|071|P|pharmacist for more details.||
1957|072|P|   Before using this medication, tell your doctor or pharmacist||
1957|073|P|your medical history, especially of: glaucoma, myasthenia gravis,||
1957|074|P|Sjogren's syndrome, stomach/intestinal problems (such as slow||
1957|075|P|gut, blockage, ulcerative colitis), trouble urinating (such as||
1957|076|P|due to enlarged prostate, bladder problems), kidney problems.||
1957|077|P|   This drug may cause temporary blurred vision. Do not drive,||
1957|078|P|use machinery, or do anything that needs clear vision until you||
1957|079|P|can do it safely.||
1957|080|P|   This medication may make you sweat less, making you more||
1957|081|P|likely to get heat stroke. If you notice you are not sweating on||
1957|082|P|your body in very warm or hot weather, stop using this||
1957|083|P|medication. Avoid doing things that may cause you to overheat,||
1957|084|P|such as hard work or exercise in hot weather, or using hot tubs.||
1957|085|P|When the weather is hot, drink a lot of fluids and dress lightly.||
1957|086|P|If you overheat, quickly look for a place to cool down and rest.||
1957|087|P|Get medical help right away if you have a fever that does not go||
1957|088|P|away, mental/mood changes, headache, or dizziness.||
1957|089|P|   Before having surgery, tell your doctor or dentist about all||
1957|090|P|the products you use (including prescription drugs,||
1957|091|P|nonprescription drugs, and herbal products).||
1957|092|P|   Tell your doctor if you are pregnant before using this||
1957|093|P|product.||
1957|094|P|   It is unknown if this medication passes into breast milk.||
1957|095|P|Consult your doctor before breastfeeding.||
1957|096|B|||
1957|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1957|098|I|medications work or increase your risk for serious side effects.||
1957|099|I|This document does not contain all possible drug interactions.||
1957|100|I|Keep a list of all the products you use (including||
1957|101|I|prescription/nonprescription drugs and herbal products) and share||
1957|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
1957|103|I|the dosage of any medicines without your doctor's approval.||
1957|104|B|||
1957|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1957|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1957|107|O|poison control center right away. US residents can call||
1957|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1957|109|B|||
1957|110|N|NOTES:  Do not share this medication with others.||
1957|111|B|||
1957|112|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1957|113|D|If it is near the time of the next dose, skip the missed dose.||
1957|114|D|Use your next dose at the regular time. Do not double the dose to||
1957|115|D|catch up.||
1957|116|B|||
1957|117|R|STORAGE:  Store at room temperature. This medication is||
1957|118|R|flammable. Keep it away from heat and open flame. Keep all||
1957|119|R|medications away from children and pets.||
1957|120|R|   Do not flush medications down the toilet or pour them into a||
1957|121|R|drain unless instructed to do so. Properly discard this product||
1957|122|R|when it is expired or no longer needed. Consult your pharmacist||
1957|123|R|or local waste disposal company.||
1957|124|B|||
1957|125|A|Information last revised October 2025.||
1957|126|A|Copyright(c) 2025 First Databank, Inc.||
1957|127|B|||
1958|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1958|002|Z|does NOT have all possible information about this product. This||
1958|003|Z|information does not assure that this product is safe, effective,||
1958|004|Z|or appropriate for you. This information is not individual||
1958|005|Z|medical advice and does not substitute for the advice of your||
1958|006|Z|health care professional. Always ask your health care||
1958|007|Z|professional for complete information about this product and your||
1958|008|Z|specific health needs.||
1958|009|B|||
1958|010|T|BRIMONIDINE 0.025% SOLUTION - OPHTHALMIC||
1958|011|F|(bri-MON-i-deen)||
1958|012|B|||
1958|013|C|COMMON BRAND NAME(S): Lumify||
1958|014|B|||
1958|015|U|USES:  Brimonidine is used to relieve redness in the eyes caused||
1958|016|U|by minor eye irritations (such as smog, swimming, dust, or||
1958|017|U|smoke).||
1958|018|B|||
1958|019|H|HOW TO USE:  Read and follow all directions on the product||
1958|020|H|package before using this medication. If you have any questions,||
1958|021|H|consult your pharmacist. If your doctor has prescribed this||
1958|022|H|medication, use it as directed.||
1958|023|H|   Use this medication in the affected eye(s), usually every 6 to||
1958|024|H|8 hours as needed. Do not use more than 4 times a day.||
1958|025|H|   To apply eye drops, wash hands first. To avoid contamination,||
1958|026|H|do not touch the dropper tip or let it touch your eye or any||
1958|027|H|other surface.||
1958|028|H|   If you are wearing contact lenses, remove them before using||
1958|029|H|eye drops. Wait at least 10 minutes before replacing your contact||
1958|030|H|lenses.||
1958|031|H|   Tilt your head back, look upward, and pull down the lower||
1958|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1958|033|H|and place one drop into the pouch. Look downward, gently close||
1958|034|H|your eyes, and place one finger at the corner of your eye (near||
1958|035|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
1958|036|H|opening your eyes. This will prevent the medication from draining||
1958|037|H|out. Try not to blink or rub your eye. Repeat these steps for||
1958|038|H|your other eye if needed. Do not rinse the dropper. Replace the||
1958|039|H|dropper cap after each use.||
1958|040|H|   If you are using another kind of eye medication (such as drops||
1958|041|H|or ointments), wait at least 5 minutes before applying other||
1958|042|H|medications. Use eye drops before eye ointments to allow the||
1958|043|H|drops to enter the eye.||
1958|044|H|   Wait several minutes for your vision to clear before driving||
1958|045|H|or operating machinery.||
1958|046|H|   Do not use if the solution has changed color or is cloudy.||
1958|047|H|   Tell your doctor if your condition lasts for more than 3 days||
1958|048|H|or if it gets worse (such as continued eye redness/irritation,||
1958|049|H|eye pain, vision changes). If you think you may have a serious||
1958|050|H|medical problem, get medical help right away.||
1958|051|B|||
1958|052|S|SIDE EFFECTS:  If your doctor has directed you to use this||
1958|053|S|medication, remember that your doctor has judged that the benefit||
1958|054|S|to you is greater than the risk of side effects. Many people||
1958|055|S|using this medication do not have serious side effects.||
1958|056|S|   A very serious allergic reaction to this drug is rare.||
1958|057|S|However, get medical help right away if you notice any symptoms||
1958|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1958|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1958|060|S|breathing.||
1958|061|S|   This is not a complete list of possible side effects. If you||
1958|062|S|notice other effects not listed above, contact your doctor or||
1958|063|S|pharmacist.||
1958|064|S|   In the US -||
1958|065|S|   Call your doctor for medical advice about side effects. You||
1958|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1958|067|S|www.fda.gov/medwatch.||
1958|068|S|   In Canada - Call your doctor for medical advice about side||
1958|069|S|effects. You may report side effects to Health Canada at||
1958|070|S|1-866-234-2345.||
1958|071|B|||
1958|072|P|PRECAUTIONS:  Before using brimonidine, tell your doctor or||
1958|073|P|pharmacist if you are allergic to it; or if you have any other||
1958|074|P|allergies. This product may contain inactive ingredients, which||
1958|075|P|can cause allergic reactions or other problems. Talk to your||
1958|076|P|pharmacist for more details.||
1958|077|P|   Before using this medication, tell your doctor or pharmacist||
1958|078|P|your medical history.||
1958|079|P|   After you apply this drug, your vision may become temporarily||
1958|080|P|blurred. Do not drive, use machinery, or do anything that needs||
1958|081|P|clear vision until you can do it safely.||
1958|082|P|   During pregnancy, this medication should be used only when||
1958|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
1958|084|P|   It is unknown if this drug passes into breast milk. Consult||
1958|085|P|your doctor before breastfeeding.||
1958|086|B|||
1958|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1958|088|I|medications work or increase your risk for serious side effects.||
1958|089|I|This document does not contain all possible drug interactions.||
1958|090|I|Keep a list of all the products you use (including||
1958|091|I|prescription/nonprescription drugs and herbal products) and share||
1958|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
1958|093|I|the dosage of any medicines without your doctor's approval.||
1958|094|B|||
1958|095|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1958|096|O|has overdosed and has serious symptoms such as passing out or||
1958|097|O|trouble breathing, call 911. Otherwise, call a poison control||
1958|098|O|center right away. US residents can call 1-800-222-1222. Canada||
1958|099|O|residents can call 1-844-764-7669.||
1958|100|B|||
1958|101|N|NOTES:  Keep all medical and lab appointments.||
1958|102|B|||
1958|103|D|MISSED DOSE:  Not applicable.||
1958|104|B|||
1958|105|R|STORAGE:  Different brands of this medication have different||
1958|106|R|storage needs. Check the product package for instructions on how||
1958|107|R|to store your brand, or ask your pharmacist. Keep all medications||
1958|108|R|away from children and pets.||
1958|109|R|   Do not flush medications down the toilet or pour them into a||
1958|110|R|drain unless instructed to do so. Properly discard this product||
1958|111|R|when it is expired or no longer needed. Consult your pharmacist||
1958|112|R|or local waste disposal company.||
1958|113|B|||
1958|114|A|Information last revised February 2025.||
1958|115|A|Copyright(c) 2025 First Databank, Inc.||
1958|116|B|||
1959|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1959|002|Z|does NOT have all possible information about this product. This||
1959|003|Z|information does not assure that this product is safe, effective,||
1959|004|Z|or appropriate for you. This information is not individual||
1959|005|Z|medical advice and does not substitute for the advice of your||
1959|006|Z|health care professional. Always ask your health care||
1959|007|Z|professional for complete information about this product and your||
1959|008|Z|specific health needs.||
1959|009|B|||
1959|010|T|DORAVIRINE/LAMIVUDINE/TENOFOVIR - ORAL||
1959|011|F|(DOR-a-VIR-een/la-MIV-ue-deen/ten-OF-oh-vir)||
1959|012|B|||
1959|013|C|COMMON BRAND NAME(S): Delstrigo||
1959|014|B|||
1959|015|W|WARNING:  If you have hepatitis B infection as well as HIV, your||
1959|016|W|hepatitis symptoms may get worse or become very serious if you||
1959|017|W|stop taking this medication. Talk with your doctor before||
1959|018|W|stopping this medication. Your doctor will check your liver||
1959|019|W|function tests for several months after you stop. Tell your||
1959|020|W|doctor right away if you develop symptoms of worsening liver||
1959|021|W|problems.||
1959|022|B|||
1959|023|U|USES:  This combination product is used by itself to help control||
1959|024|U|HIV infection. It helps to decrease the amount of HIV in your||
1959|025|U|body so your immune system can work better. This lowers your||
1959|026|U|chance of getting HIV complications (such as new infections,||
1959|027|U|cancer) and improves your quality of life. This product is a||
1959|028|U|combination of 3 different drugs: doravirine, lamivudine, and||
1959|029|U|tenofovir. Doravirine belongs to a class of drugs known as||
1959|030|U|non-nucleoside reverse transcriptase inhibitors (NNRTIs).||
1959|031|U|Lamivudine is called a nucleoside reverse transcriptase inhibitor||
1959|032|U|and tenofovir is called a nucleotide reverse transcriptase||
1959|033|U|inhibitor. Lamivudine and tenofovir are often called NRTIs.||
1959|034|U|   Doravirine/lamivudine/tenofovir is not a cure for HIV||
1959|035|U|infection. To decrease your risk of spreading HIV disease to||
1959|036|U|others, continue to take all HIV medications exactly as||
1959|037|U|prescribed by your doctor. Use an effective barrier method (latex||
1959|038|U|or polyurethane condoms/dental dams) during sexual activity as||
1959|039|U|directed by your doctor. Do not share personal items (such as||
1959|040|U|needles/syringes, toothbrushes, and razors) that may have||
1959|041|U|contacted blood or other body fluids. Consult your doctor or||
1959|042|U|pharmacist for more details.||
1959|043|B|||
1959|044|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1959|045|H|from your pharmacist before you start taking||
1959|046|H|doravirine/lamivudine/tenofovir and each time you get a refill.||
1959|047|H|If you have any questions, ask your doctor or pharmacist.||
1959|048|H|   Take this medication by mouth with or without food as directed||
1959|049|H|by your doctor, usually once daily.||
1959|050|H|   The dosage is based on other medications you may be taking. Be||
1959|051|H|sure to tell your doctor and pharmacist about all the drugs you||
1959|052|H|use (including prescription/nonprescription drugs and herbal||
1959|053|H|products).||
1959|054|H|   It is very important to keep taking this medication exactly as||
1959|055|H|prescribed by your doctor. Do not skip any doses.||
1959|056|H|   For the best effect, take this medication at evenly spaced||
1959|057|H|times. To help you remember, take this medication at the same||
1959|058|H|time every day.||
1959|059|H|   Do not take more or less of this drug than prescribed or stop||
1959|060|H|taking it even for a short time unless directed to do so by your||
1959|061|H|doctor. Doing so may cause the amount of virus to increase, make||
1959|062|H|the infection more difficult to treat (resistant), or worsen side||
1959|063|H|effects.||
1959|064|B|||
1959|065|S|SIDE EFFECTS:  Dizziness, drowsiness, nausea, trouble sleeping,||
1959|066|S|or unusual dreams may occur. If any of these effects last or get||
1959|067|S|worse, tell your doctor or pharmacist promptly.||
1959|068|S|   Remember that this medication has been prescribed because your||
1959|069|S|doctor has judged that the benefit to you is greater than the||
1959|070|S|risk of side effects. Many people using this medication do not||
1959|071|S|have serious side effects.||
1959|072|S|   As your immune system gets stronger, it can begin to fight off||
1959|073|S|infections you already had, possibly causing disease symptoms to||
1959|074|S|come back. You could also have symptoms if your immune system||
1959|075|S|becomes overactive. This reaction may happen at any time (soon||
1959|076|S|after starting HIV treatment or many months later). Tell your||
1959|077|S|doctor right away if you have any serious symptoms, including:||
1959|078|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1959|079|S|that doesn't go away, headaches that are severe or don't go away,||
1959|080|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1959|081|S|changes, signs of infection (such as sore throat that doesn't go||
1959|082|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1959|083|S|sores), signs of an overactive thyroid (such as irritability,||
1959|084|S|nervousness, heat intolerance, fast/pounding/irregular||
1959|085|S|heartbeat).||
1959|086|S|   Tell your doctor right away if you have any serious side||
1959|087|S|effects, including: mental/mood changes (such as depression, rare||
1959|088|S|thoughts of suicide, strange thoughts, anxiety), signs of kidney||
1959|089|S|problems (such as a change in the amount of urine), signs of a||
1959|090|S|buildup of lactic acid in the blood (such as unusual tiredness,||
1959|091|S|dizziness, severe drowsiness, chills, blue/cold skin, muscle||
1959|092|S|pain, fast/difficult breathing, slow/irregular heartbeat, or||
1959|093|S|stomach pain with nausea/vomiting/diarrhea), signs of liver||
1959|094|S|problems (such as nausea/vomiting that doesn't stop, loss of||
1959|095|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
1959|096|S|urine), signs of pancreatitis (such as nausea, vomiting,||
1959|097|S|stomach/abdominal/back pain, fever).||
1959|098|S|   Changes in body fat may occur while you are taking this||
1959|099|S|medication (such as increased fat in the upper back and stomach||
1959|100|S|areas, decreased fat in the arms and legs). The cause and||
1959|101|S|long-term effects of these changes are unknown. Discuss the risks||
1959|102|S|and benefits of treatment with your doctor, as well as the||
1959|103|S|possible use of exercise to reduce this side effect.||
1959|104|S|   Tenofovir may increase the risk of bone loss. Discuss the||
1959|105|S|risks and benefits of treatment with your doctor, as well as the||
1959|106|S|possible use of calcium and vitamin D to reduce this side effect.||
1959|107|S|If you are at risk for bone loss, your doctor may monitor your||
1959|108|S|bone mineral density. Tell your doctor right away if any of the||
1959|109|S|following serious side effects occur: bone pain, easily broken||
1959|110|S|bones.||
1959|111|S|   A very serious allergic reaction to this drug is rare.||
1959|112|S|However, get medical help right away if you notice any symptoms||
1959|113|S|of a serious allergic reaction, including: rash, itching/swelling||
1959|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1959|115|S|breathing.||
1959|116|S|   This is not a complete list of possible side effects. If you||
1959|117|S|notice other effects not listed above, contact your doctor or||
1959|118|S|pharmacist.||
1959|119|S|   In the US -||
1959|120|S|   Call your doctor for medical advice about side effects. You||
1959|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1959|122|S|www.fda.gov/medwatch.||
1959|123|S|   In Canada - Call your doctor for medical advice about side||
1959|124|S|effects. You may report side effects to Health Canada at||
1959|125|S|1-866-234-2345.||
1959|126|B|||
1959|127|P|PRECAUTIONS:  Before taking doravirine/lamivudine/tenofovir, tell||
1959|128|P|your doctor or pharmacist if you are allergic to any of the||
1959|129|P|ingredients; or if you have any other allergies. This product may||
1959|130|P|contain inactive ingredients, which can cause allergic reactions||
1959|131|P|or other problems. Talk to your pharmacist for more details.||
1959|132|P|   Before using this medication, tell your doctor or pharmacist||
1959|133|P|your medical history, especially of: kidney problems, liver||
1959|134|P|problems (such as hepatitis B or C, cirrhosis), mental/mood||
1959|135|P|conditions (such as depression, thoughts of suicide, psychosis),||
1959|136|P|bone problems (such as bone disease, bone loss/osteoporosis,||
1959|137|P|weak/broken bones), disease of the pancreas (pancreatitis).||
1959|138|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1959|139|P|(cannabis) can worsen dizziness or drowsiness. Do not drive, use||
1959|140|P|machinery, or do anything that needs alertness until you can do||
1959|141|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
1959|142|P|are using marijuana (cannabis).||
1959|143|P|   Before having surgery, tell your doctor or dentist about all||
1959|144|P|the products you use (including prescription drugs,||
1959|145|P|nonprescription drugs, and herbal products).||
1959|146|P|   During pregnancy, this medication should be used only when||
1959|147|P|clearly needed. Treatment can lower the risk of passing HIV||
1959|148|P|infection to your baby, and doravirine/lamivudine/tenofovir may||
1959|149|P|be part of that treatment. Discuss the risks and benefits with||
1959|150|P|your doctor.||
1959|151|P|   Lamivudine and tenofovir pass into breast milk. It is unknown||
1959|152|P|if doravirine passes into breast milk. Because breast milk may||
1959|153|P|transmit HIV, consult your doctor before breastfeeding.||
1959|154|B|||
1959|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1959|156|I|medications work or increase your risk for serious side effects.||
1959|157|I|This document does not contain all possible drug interactions.||
1959|158|I|Keep a list of all the products you use (including||
1959|159|I|prescription/nonprescription drugs and herbal products) and share||
1959|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
1959|161|I|the dosage of any medicines without your doctor's approval.||
1959|162|I|   Some products that may interact with this drug are: orlistat,||
1959|163|I|sorbitol, other drugs that may affect the kidneys (including||
1959|164|I|adefovir, cidofovir, aminoglycosides such as||
1959|165|I|amikacin/gentamicin).||
1959|166|I|   Do not take this medication with other products that contain||
1959|167|I|lamivudine or tenofovir. Only take this medication with||
1959|168|I|doravirine if specifically directed by your doctor.||
1959|169|I|   Other medications can affect the removal of||
1959|170|I|doravirine/lamivudine/tenofovir from your body, which may affect||
1959|171|I|how this product works. Examples include apalutamide, butalbital,||
1959|172|I|enzalutamide, mitotane, rifampin, secobarbital, St. John's wort,||
1959|173|I|some drugs used to treat seizures (such as carbamazepine,||
1959|174|I|phenobarbital, phenytoin, primidone), among others.||
1959|175|I|   This medication may interfere with certain lab tests||
1959|176|I|(including urine cannabinoid tests), possibly causing false test||
1959|177|I|results. Make sure lab personnel and all your doctors know you||
1959|178|I|use this drug.||
1959|179|B|||
1959|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1959|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1959|182|O|poison control center right away. US residents can call||
1959|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1959|184|B|||
1959|185|N|NOTES:  Do not share this medication with others.||
1959|186|N|   Lab and/or medical tests (such as kidney/liver tests, urine||
1959|187|N|glucose/protein, viral load, T-cell counts, bone density tests)||
1959|188|N|should be done before you start taking this medication and while||
1959|189|N|you are taking it. Keep all medical and lab appointments.||
1959|190|B|||
1959|191|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1959|192|D|remember. If it is near the time of the next dose, skip the||
1959|193|D|missed dose. Take your next dose at the regular time. Do not||
1959|194|D|double the dose to catch up.||
1959|195|B|||
1959|196|R|STORAGE:  Store in the original bottle at room temperature away||
1959|197|R|from light and moisture. Do not store in the bathroom. Keep the||
1959|198|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1959|199|R|when not in use. Keep all medications away from children and||
1959|200|R|pets.||
1959|201|R|   Do not flush medications down the toilet or pour them into a||
1959|202|R|drain unless instructed to do so. Properly discard this product||
1959|203|R|when it is expired or no longer needed. Consult your pharmacist||
1959|204|R|or local waste disposal company.||
1959|205|B|||
1959|206|A|Information last revised April 2025.||
1959|207|A|Copyright(c) 2025 First Databank, Inc.||
1959|208|B|||
1960|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1960|002|Z|does NOT have all possible information about this product. This||
1960|003|Z|information does not assure that this product is safe, effective,||
1960|004|Z|or appropriate for you. This information is not individual||
1960|005|Z|medical advice and does not substitute for the advice of your||
1960|006|Z|health care professional. Always ask your health care||
1960|007|Z|professional for complete information about this product and your||
1960|008|Z|specific health needs.||
1960|009|B|||
1960|010|T|IOHEXOL LIQUID - ORAL||
1960|011|F|(EYE-oh-HEX-ol)||
1960|012|B|||
1960|013|C|COMMON BRAND NAME(S): Omnipaque||
1960|014|B|||
1960|015|U|USES:  This medication is used before X-ray imaging tests (such||
1960|016|U|as CT scans). Iohexol contains iodine and belongs to a class of||
1960|017|U|drugs known as contrast media or dyes. It works by adding||
1960|018|U|contrast to body parts and fluids in these imaging tests. Iohexol||
1960|019|U|improves the images obtained during a CT scan, so your doctor can||
1960|020|U|more easily diagnose your condition.||
1960|021|B|||
1960|022|H|HOW TO USE:  Read your doctor's specific instructions on when and||
1960|023|H|how to take iohexol before your imaging test. Take this||
1960|024|H|medication by mouth as directed by your doctor. It is usually||
1960|025|H|taken just before the imaging test. The dosage is based on the||
1960|026|H|specific imaging test and your age.||
1960|027|H|   Drink plenty of fluids before and after the imaging test,||
1960|028|H|unless directed otherwise by your doctor.||
1960|029|B|||
1960|030|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, stomach pain, gas, or||
1960|031|S|headache may occur. If any of these effects last or get worse,||
1960|032|S|tell your doctor or pharmacist promptly.||
1960|033|S|   Remember that this medication has been prescribed because your||
1960|034|S|doctor has judged that the benefit to you is greater than the||
1960|035|S|risk of side effects. Many people using this medication do not||
1960|036|S|have serious side effects.||
1960|037|S|   Tell your doctor right away if you have any serious side||
1960|038|S|effects, including: signs of kidney problems (such as change in||
1960|039|S|the amount of urine).||
1960|040|S|   A very serious allergic reaction to this drug is rare.||
1960|041|S|However, get medical help right away if you notice any symptoms||
1960|042|S|of a serious allergic reaction, including: rash, itching/swelling||
1960|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1960|044|S|breathing.||
1960|045|S|   This is not a complete list of possible side effects. If you||
1960|046|S|notice other effects not listed above, contact your doctor or||
1960|047|S|pharmacist.||
1960|048|S|   In the US -||
1960|049|S|   Call your doctor for medical advice about side effects. You||
1960|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1960|051|S|www.fda.gov/medwatch.||
1960|052|S|   In Canada - Call your doctor for medical advice about side||
1960|053|S|effects. You may report side effects to Health Canada at||
1960|054|S|1-866-234-2345.||
1960|055|B|||
1960|056|P|PRECAUTIONS:  Before taking iohexol, tell your doctor or||
1960|057|P|pharmacist if you are allergic to it; or to other contrast media;||
1960|058|P|or to iodine; or if you have any other allergies. This product||
1960|059|P|may contain inactive ingredients, which can cause allergic||
1960|060|P|reactions or other problems. Talk to your pharmacist for more||
1960|061|P|details.||
1960|062|P|   Before using this medication, tell your doctor or pharmacist||
1960|063|P|your medical history, especially of: asthma, hay fever, kidney||
1960|064|P|disease.||
1960|065|P|   Before having surgery, tell your doctor or dentist about all||
1960|066|P|the products you use (including prescription drugs,||
1960|067|P|nonprescription drugs, and herbal products).||
1960|068|P|   During pregnancy, this medication should be used only when||
1960|069|P|clearly needed. Discuss the risks and benefits with your doctor.||
1960|070|P|   When taken by mouth, this medication is unlikely to pass into||
1960|071|P|breast milk. Consult your doctor before breastfeeding.||
1960|072|B|||
1960|073|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1960|074|I|medications work or increase your risk for serious side effects.||
1960|075|I|This document does not contain all possible drug interactions.||
1960|076|I|Keep a list of all the products you use (including||
1960|077|I|prescription/nonprescription drugs and herbal products) and share||
1960|078|I|it with your doctor and pharmacist. Do not start, stop, or change||
1960|079|I|the dosage of any medicines without your doctor's approval.||
1960|080|I|   One product that may interact with this drug is: metformin.||
1960|081|I|   This medication may interfere with certain lab tests (such as||
1960|082|I|protein-bound iodine test), possibly causing false test results.||
1960|083|I|Make sure lab personnel and all your doctors know you use this||
1960|084|I|drug.||
1960|085|B|||
1960|086|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1960|087|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1960|088|O|poison control center right away. US residents can call||
1960|089|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1960|090|B|||
1960|091|N|NOTES:  Do not share this medication with others.||
1960|092|B|||
1960|093|D|MISSED DOSE:  Not applicable. This medication is given once||
1960|094|D|before your imaging test. It is important to take this medication||
1960|095|D|at the time prescribed by your doctor. If you forget to take the||
1960|096|D|dose, your imaging test may need to be rescheduled.||
1960|097|B|||
1960|098|R|STORAGE:  Store in the refrigerator or at room temperature away||
1960|099|R|from light. Do not freeze. Keep all medications away from||
1960|100|R|children and pets.||
1960|101|R|   Do not flush medications down the toilet or pour them into a||
1960|102|R|drain unless instructed to do so. Properly discard this product||
1960|103|R|when it is expired or no longer needed. Consult your pharmacist||
1960|104|R|or local waste disposal company.||
1960|105|B|||
1960|106|A|Information last revised October 2024.||
1960|107|A|Copyright(c) 2025 First Databank, Inc.||
1960|108|B|||
1961|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1961|002|Z|does NOT have all possible information about this product. This||
1961|003|Z|information does not assure that this product is safe, effective,||
1961|004|Z|or appropriate for you. This information is not individual||
1961|005|Z|medical advice and does not substitute for the advice of your||
1961|006|Z|health care professional. Always ask your health care||
1961|007|Z|professional for complete information about this product and your||
1961|008|Z|specific health needs.||
1961|009|B|||
1961|010|T|DORAVIRINE - ORAL||
1961|011|F|(DOR-a-VIR-een)||
1961|012|B|||
1961|013|C|COMMON BRAND NAME(S): Pifeltro||
1961|014|B|||
1961|015|U|USES:  This drug is used with other HIV medications to help||
1961|016|U|control HIV infection. It helps to decrease the amount of HIV in||
1961|017|U|your body so your immune system can work better. This lowers your||
1961|018|U|chance of getting HIV complications (such as new infections,||
1961|019|U|cancer) and improves your quality of life. Doravirine belongs to||
1961|020|U|a class of drugs known as non-nucleoside reverse transcriptase||
1961|021|U|inhibitors (NNRTIs).||
1961|022|U|   Doravirine is not a cure for HIV infection. To decrease your||
1961|023|U|risk of spreading HIV disease to others, continue to take all HIV||
1961|024|U|medications exactly as prescribed by your doctor. Use an||
1961|025|U|effective barrier method (latex or polyurethane condoms/dental||
1961|026|U|dams) during sexual activity as directed by your doctor. Do not||
1961|027|U|share personal items (such as needles/syringes, toothbrushes, and||
1961|028|U|razors) that may have contacted blood or other body fluids.||
1961|029|U|Consult your doctor or pharmacist for more details.||
1961|030|B|||
1961|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1961|032|H|from your pharmacist before you start taking doravirine and each||
1961|033|H|time you get a refill. If you have any questions, ask your doctor||
1961|034|H|or pharmacist.||
1961|035|H|   Take this medication by mouth with or without food as directed||
1961|036|H|by your doctor, usually once daily. The dosage is based on your||
1961|037|H|medical condition, response to treatment, and other medications||
1961|038|H|you may be taking. Be sure to tell your doctor and pharmacist||
1961|039|H|about all the drugs you use (including||
1961|040|H|prescription/nonprescription drugs and herbal products).||
1961|041|H|   It is very important to keep taking this medication (and other||
1961|042|H|HIV medications) exactly as prescribed by your doctor. Do not||
1961|043|H|skip any doses.||
1961|044|H|   For the best effect, take this medication at evenly spaced||
1961|045|H|times. To help you remember, take this medication at the same||
1961|046|H|time every day.||
1961|047|H|   Do not take more or less of this drug than prescribed or stop||
1961|048|H|taking it (or other HIV medicines) even for a short time unless||
1961|049|H|directed to do so by your doctor. Doing so may cause the amount||
1961|050|H|of virus to increase, make the infection more difficult to treat||
1961|051|H|(resistant), or worsen side effects.||
1961|052|B|||
1961|053|S|SIDE EFFECTS:  Nausea, headache, tiredness, abdominal pain,||
1961|054|S|diarrhea, dizziness, or unusual dreams may occur. If any of these||
1961|055|S|effects last or get worse, tell your doctor or pharmacist||
1961|056|S|promptly.||
1961|057|S|   Remember that this medication has been prescribed because your||
1961|058|S|doctor has judged that the benefit to you is greater than the||
1961|059|S|risk of side effects. Many people using this medication do not||
1961|060|S|have serious side effects.||
1961|061|S|   As your immune system gets stronger, it can begin to fight off||
1961|062|S|infections you already had, possibly causing disease symptoms to||
1961|063|S|come back. You could also have symptoms if your immune system||
1961|064|S|becomes overactive. This reaction may happen at any time (soon||
1961|065|S|after starting HIV treatment or many months later). Tell your||
1961|066|S|doctor right away if you have any serious symptoms, including:||
1961|067|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
1961|068|S|that doesn't go away, headaches that are severe or don't go away,||
1961|069|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
1961|070|S|changes, signs of infection (such as sore throat that doesn't go||
1961|071|S|away, fever, chills, swollen lymph nodes, non-healing skin||
1961|072|S|sores), signs of an overactive thyroid (such as irritability,||
1961|073|S|nervousness, heat intolerance, fast/pounding/irregular||
1961|074|S|heartbeat), signs of liver disease (such as nausea/vomiting that||
1961|075|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
1961|076|S|eyes/skin, dark urine).||
1961|077|S|   Tell your doctor right away if you have any serious side||
1961|078|S|effects, including: mental/mood changes (such as depression, rare||
1961|079|S|thoughts of suicide, strange thoughts, anxiety).||
1961|080|S|   Changes in body fat may occur while you are taking this||
1961|081|S|medication (such as increased fat in the upper back and stomach||
1961|082|S|areas, decreased fat in the arms and legs). The cause and||
1961|083|S|long-term effects of these changes are unknown. Discuss the risks||
1961|084|S|and benefits of treatment with your doctor, as well as the||
1961|085|S|possible use of exercise to reduce this side effect.||
1961|086|S|   A very serious allergic reaction to this drug is rare.||
1961|087|S|However, get medical help right away if you notice any symptoms||
1961|088|S|of a serious allergic reaction, including: rash, itching/swelling||
1961|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1961|090|S|breathing.||
1961|091|S|   This is not a complete list of possible side effects. If you||
1961|092|S|notice other effects not listed above, contact your doctor or||
1961|093|S|pharmacist.||
1961|094|S|   In the US -||
1961|095|S|   Call your doctor for medical advice about side effects. You||
1961|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1961|097|S|www.fda.gov/medwatch.||
1961|098|S|   In Canada - Call your doctor for medical advice about side||
1961|099|S|effects. You may report side effects to Health Canada at||
1961|100|S|1-866-234-2345.||
1961|101|B|||
1961|102|P|PRECAUTIONS:  Before taking doravirine, tell your doctor or||
1961|103|P|pharmacist if you are allergic to it; or if you have any other||
1961|104|P|allergies. This product may contain inactive ingredients, which||
1961|105|P|can cause allergic reactions or other problems. Talk to your||
1961|106|P|pharmacist for more details.||
1961|107|P|   Before using this medication, tell your doctor or pharmacist||
1961|108|P|your medical history, especially of: liver problems (such as||
1961|109|P|hepatitis B or C, cirrhosis).||
1961|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1961|111|P|can make you more dizzy. Do not drive, use machinery, or do||
1961|112|P|anything that needs alertness until you can do it safely. Limit||
1961|113|P|alcoholic beverages. Talk to your doctor if you are using||
1961|114|P|marijuana (cannabis).||
1961|115|P|   Before having surgery, tell your doctor or dentist about all||
1961|116|P|the products you use (including prescription drugs,||
1961|117|P|nonprescription drugs, and herbal products).||
1961|118|P|   During pregnancy, this medication should be used only when||
1961|119|P|clearly needed. Treatment can lower the risk of passing HIV||
1961|120|P|infection to your baby, and doravirine may be part of that||
1961|121|P|treatment. Discuss the risks and benefits with your doctor.||
1961|122|P|   It is unknown if this medication passes into breast milk.||
1961|123|P|Because breast milk may transmit HIV, consult your doctor before||
1961|124|P|breastfeeding.||
1961|125|B|||
1961|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1961|127|I|medications work or increase your risk for serious side effects.||
1961|128|I|This document does not contain all possible drug interactions.||
1961|129|I|Keep a list of all the products you use (including||
1961|130|I|prescription/nonprescription drugs and herbal products) and share||
1961|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
1961|132|I|the dosage of any medicines without your doctor's approval.||
1961|133|I|   Other medications can affect the removal of doravirine from||
1961|134|I|your body, which may affect how this product works. Examples||
1961|135|I|include apalutamide, butalbital, enzalutamide, mitotane,||
1961|136|I|rifampin, secobarbital, St. John's wort, some drugs used to treat||
1961|137|I|seizures (such as carbamazepine, phenobarbital, phenytoin,||
1961|138|I|primidone), among others.||
1961|139|B|||
1961|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1961|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1961|142|O|poison control center right away. US residents can call||
1961|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1961|144|B|||
1961|145|N|NOTES:  Do not share this medication with others.||
1961|146|N|   Lab and/or medical tests (such as viral load, T-cell counts)||
1961|147|N|should be done before you start taking this medication and while||
1961|148|N|you are taking it. Keep all medical and lab appointments. Consult||
1961|149|N|your doctor for more details.||
1961|150|B|||
1961|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1961|152|D|remember. If it is near the time of the next dose, skip the||
1961|153|D|missed dose. Take your next dose at the regular time. Do not||
1961|154|D|double the dose to catch up.||
1961|155|B|||
1961|156|R|STORAGE:  Store in the original bottle at room temperature away||
1961|157|R|from light and moisture. Do not store in the bathroom. Keep the||
1961|158|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
1961|159|R|when not in use. Keep all medications away from children and||
1961|160|R|pets.||
1961|161|R|   Do not flush medications down the toilet or pour them into a||
1961|162|R|drain unless instructed to do so. Properly discard this product||
1961|163|R|when it is expired or no longer needed. Consult your pharmacist||
1961|164|R|or local waste disposal company.||
1961|165|B|||
1961|166|A|Information last revised April 2025.||
1961|167|A|Copyright(c) 2025 First Databank, Inc.||
1961|168|B|||
1962|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1962|002|Z|does NOT have all possible information about this product. This||
1962|003|Z|information does not assure that this product is safe, effective,||
1962|004|Z|or appropriate for you. This information is not individual||
1962|005|Z|medical advice and does not substitute for the advice of your||
1962|006|Z|health care professional. Always ask your health care||
1962|007|Z|professional for complete information about this product and your||
1962|008|Z|specific health needs.||
1962|009|B|||
1962|010|T|FREMANEZUMAB - SUBCUTANEOUS INJECTION||
1962|011|F|(FREE-ma-NEZ-ue-mab)||
1962|012|B|||
1962|013|C|COMMON BRAND NAME(S): Ajovy||
1962|014|B|||
1962|015|U|USES:  This medication is used to help prevent migraine. This||
1962|016|U|medication may work by changing the amounts of certain natural||
1962|017|U|substances in the brain. Fremanezumab belongs to a class of drugs||
1962|018|U|known as monoclonal antibodies. Preventing frequent migraine||
1962|019|U|attacks can help improve your ability to concentrate and do your||
1962|020|U|usual tasks.||
1962|021|B|||
1962|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
1962|023|H|Instructions for Use provided by your pharmacist before you start||
1962|024|H|using fremanezumab and each time you get a refill. Ask your||
1962|025|H|health care professional how to prepare and use this medication.||
1962|026|H|If you have any questions, ask your doctor or pharmacist.||
1962|027|H|   Inject this medication under the skin as directed by your||
1962|028|H|doctor, usually once every month, or once every 3 months. The||
1962|029|H|injection is given in the thigh, abdomen, or upper arm. The||
1962|030|H|dosage is based on your medical condition and response to||
1962|031|H|treatment.||
1962|032|H|   Take the medication out of the refrigerator at least 30||
1962|033|H|minutes before you inject it to allow it to reach room||
1962|034|H|temperature. Do not warm up this medication any other way (for||
1962|035|H|example, do not heat it in the microwave, place it in hot water,||
1962|036|H|or leave it in direct sunlight). Do not shake the medication.||
1962|037|H|Before using, check this product for particles or discoloration.||
1962|038|H|If either is present, do not use the liquid. Before injecting||
1962|039|H|each dose, clean the skin you are going to inject into (the||
1962|040|H|injection site) with rubbing alcohol. Change the injection site||
1962|041|H|each time to lessen injury under the skin. Do not inject into||
1962|042|H|skin that is tender, bruised, red, tattooed, or hard, or into||
1962|043|H|scars or stretch marks. To lessen bruising, do not rub the||
1962|044|H|injection site after a shot. Learn how to store and discard||
1962|045|H|medical supplies safely.||
1962|046|H|   Use this medication regularly to get the most benefit from it.||
1962|047|H|To help you remember, mark your calendar with a reminder.||
1962|048|H|   Tell your doctor if your migraines happen more often or get||
1962|049|H|worse.||
1962|050|B|||
1962|051|S|SIDE EFFECTS:  Redness, pain, or swelling at the injection site||
1962|052|S|may occur. If any of these effects last or get worse, tell your||
1962|053|S|doctor or pharmacist promptly.||
1962|054|S|   Remember that this medication has been prescribed because your||
1962|055|S|doctor has judged that the benefit to you is greater than the||
1962|056|S|risk of side effects. Many people using this medication do not||
1962|057|S|have serious side effects.||
1962|058|S|   This medication may raise your blood pressure. Check your||
1962|059|S|blood pressure regularly and tell your doctor if the results are||
1962|060|S|high. Your doctor may control your blood pressure with||
1962|061|S|medication.||
1962|062|S|   Tell your doctor right away if you have any serious side||
1962|063|S|effects, including: blue fingers/toes, cold hands/feet.||
1962|064|S|   A very serious allergic reaction to this drug is rare.||
1962|065|S|However, get medical help right away if you notice any symptoms||
1962|066|S|of a serious allergic reaction, including: rash, itching/swelling||
1962|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1962|068|S|breathing.||
1962|069|S|   This is not a complete list of possible side effects. If you||
1962|070|S|notice other effects not listed above, contact your doctor or||
1962|071|S|pharmacist.||
1962|072|S|   In the US -||
1962|073|S|   Call your doctor for medical advice about side effects. You||
1962|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1962|075|S|www.fda.gov/medwatch.||
1962|076|S|   In Canada - Call your doctor for medical advice about side||
1962|077|S|effects. You may report side effects to Health Canada at||
1962|078|S|1-866-234-2345.||
1962|079|B|||
1962|080|P|PRECAUTIONS:  Before using fremanezumab, tell your doctor or||
1962|081|P|pharmacist if you are allergic to it; or if you have any other||
1962|082|P|allergies. This product may contain inactive ingredients, which||
1962|083|P|can cause allergic reactions or other problems. Talk to your||
1962|084|P|pharmacist for more details.||
1962|085|P|   Before using this medication, tell your doctor or pharmacist||
1962|086|P|your medical history, especially of: blood circulation problems||
1962|087|P|(such as Raynaud's disease), high blood pressure.||
1962|088|P|   Before having surgery, tell your doctor or dentist about all||
1962|089|P|the products you use (including prescription drugs,||
1962|090|P|nonprescription drugs, and herbal products).||
1962|091|P|   During pregnancy, this medication should be used only when||
1962|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
1962|093|P|   It is unknown if this medication passes into breast milk.||
1962|094|P|Consult your doctor before breastfeeding.||
1962|095|B|||
1962|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1962|097|I|medications work or increase your risk for serious side effects.||
1962|098|I|This document does not contain all possible drug interactions.||
1962|099|I|Keep a list of all the products you use (including||
1962|100|I|prescription/nonprescription drugs and herbal products) and share||
1962|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
1962|102|I|the dosage of any medicines without your doctor's approval.||
1962|103|B|||
1962|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1962|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1962|106|O|poison control center right away. US residents can call||
1962|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1962|108|B|||
1962|109|N|NOTES:  Do not share this medication with others.||
1962|110|N|   Lab and/or medical tests (such as blood pressure) may be done||
1962|111|N|while you are using this medication. Keep all medical and lab||
1962|112|N|appointments. Consult your doctor for more details.||
1962|113|B|||
1962|114|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1962|115|D|After that, continue to use this medication once every month or||
1962|116|D|once every 3 months from the date of your last dose. Do not||
1962|117|D|double the dose to catch up. If you have questions about your||
1962|118|D|schedule, ask your doctor or pharmacist.||
1962|119|B|||
1962|120|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1962|121|R|medication in the original package to protect from light. This||
1962|122|R|medication may also be stored at room temperature if needed. If||
1962|123|R|the medication is stored at room temperature, do not put it back||
1962|124|R|in the refrigerator and discard after 7 days. Do not leave the||
1962|125|R|syringe in direct sunlight. Keep all medications away from||
1962|126|R|children and pets.||
1962|127|R|   Do not flush medications down the toilet or pour them into a||
1962|128|R|drain unless instructed to do so. Properly discard this product||
1962|129|R|when it is expired or no longer needed. Consult your pharmacist||
1962|130|R|or local waste disposal company.||
1962|131|B|||
1962|132|A|Information last revised March 2025.||
1962|133|A|Copyright(c) 2025 First Databank, Inc.||
1962|134|B|||
1963|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1963|002|Z|does NOT have all possible information about this product. This||
1963|003|Z|information does not assure that this product is safe, effective,||
1963|004|Z|or appropriate for you. This information is not individual||
1963|005|Z|medical advice and does not substitute for the advice of your||
1963|006|Z|health care professional. Always ask your health care||
1963|007|Z|professional for complete information about this product and your||
1963|008|Z|specific health needs.||
1963|009|B|||
1963|010|T|ERAVACYCLINE - INJECTION||
1963|011|F|(ER-a-va-SYE-kleen)||
1963|012|B|||
1963|013|C|COMMON BRAND NAME(S): Xerava||
1963|014|B|||
1963|015|U|USES:  Eravacycline is used to treat certain abdominal infections||
1963|016|U|(such as appendicitis, diverticulitis, gastric/intestinal||
1963|017|U|perforation). This medication belongs to a class of drugs known||
1963|018|U|as tetracycline antibiotics. It works by stopping the growth of||
1963|019|U|bacteria.||
1963|020|B|||
1963|021|H|HOW TO USE:  This medication is given by slow injection into a||
1963|022|H|vein (over 60 minutes) as directed by your doctor, usually every||
1963|023|H|12 hours. The dosage is based on your weight, medical condition,||
1963|024|H|response to treatment, and other medications you may be taking.||
1963|025|H|Be sure to tell your doctor and pharmacist about all the products||
1963|026|H|you use (including prescription drugs, nonprescription drugs, and||
1963|027|H|herbal products).||
1963|028|H|   If you are using this medication at home, learn all||
1963|029|H|preparation and usage instructions from your health care||
1963|030|H|professional. Before using, check this product for particles or||
1963|031|H|discoloration. If either is present, do not use the liquid. Learn||
1963|032|H|how to store and discard medical supplies safely.||
1963|033|H|   For the best effect, use this antibiotic at evenly spaced||
1963|034|H|times. To help you remember, use this medication at the same||
1963|035|H|times every day.||
1963|036|H|   Continue to use this medication until the full prescribed||
1963|037|H|amount is finished, even if symptoms disappear after a few days.||
1963|038|H|Stopping the medication too early may result in a return of the||
1963|039|H|infection.||
1963|040|H|   Tell your doctor if your condition lasts or gets worse.||
1963|041|B|||
1963|042|S|SIDE EFFECTS:  Pain, redness, and tenderness at the injection||
1963|043|S|site may occur. Nausea, vomiting, or diarrhea may also occur. If||
1963|044|S|any of these effects last or get worse, tell your doctor or||
1963|045|S|pharmacist promptly.||
1963|046|S|   Remember that this medication has been prescribed because your||
1963|047|S|doctor has judged that the benefit to you is greater than the||
1963|048|S|risk of side effects. Many people using this medication do not||
1963|049|S|have serious side effects.||
1963|050|S|   Tell your doctor right away if you have any serious side||
1963|051|S|effects, including: yellow-gray-brown tooth discoloration, signs||
1963|052|S|of kidney problems (such as change in the amount of urine, pink||
1963|053|S|urine), signs of liver problems (such as loss of appetite,||
1963|054|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1963|055|S|   Eravacycline may rarely cause increased pressure around the||
1963|056|S|brain (intracranial hypertension-IH). The risk of this side||
1963|057|S|effect is greater for women of childbearing age who are||
1963|058|S|overweight or who have had IH in the past. If IH develops, it||
1963|059|S|usually goes away after eravacycline is stopped; however, there||
1963|060|S|is a chance of permanent vision loss or blindness. Get medical||
1963|061|S|help right away if you have: severe/lasting headache, vision||
1963|062|S|changes (such as blurred/double vision, decreased vision, sudden||
1963|063|S|blindness), nausea/vomiting that doesn't stop.||
1963|064|S|   This medication may rarely cause a severe intestinal condition||
1963|065|S|due to a bacteria called C. difficile. This condition may occur||
1963|066|S|during treatment or weeks to months after treatment has stopped.||
1963|067|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1963|068|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1963|069|S|stool.||
1963|070|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1963|071|S|products because they may make symptoms worse.||
1963|072|S|   Use of this medication for prolonged or repeated periods may||
1963|073|S|result in oral thrush or a new yeast infection. Contact your||
1963|074|S|doctor if you notice white patches in your mouth, a change in||
1963|075|S|vaginal discharge, or other new symptoms.||
1963|076|S|   A very serious allergic reaction to this drug is rare.||
1963|077|S|However, get medical help right away if you notice any symptoms||
1963|078|S|of a serious allergic reaction, including: rash, itching/swelling||
1963|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1963|080|S|breathing.||
1963|081|S|   This is not a complete list of possible side effects. If you||
1963|082|S|notice other effects not listed above, contact your doctor or||
1963|083|S|pharmacist.||
1963|084|S|   In the US -||
1963|085|S|   Call your doctor for medical advice about side effects. You||
1963|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1963|087|S|www.fda.gov/medwatch.||
1963|088|S|   In Canada - Call your doctor for medical advice about side||
1963|089|S|effects. You may report side effects to Health Canada at||
1963|090|S|1-866-234-2345.||
1963|091|B|||
1963|092|P|PRECAUTIONS:  Before using eravacycline, tell your doctor or||
1963|093|P|pharmacist if you are allergic to it; or to other tetracyclines||
1963|094|P|(such as doxycycline); or if you have any other allergies. This||
1963|095|P|product may contain inactive ingredients, which can cause||
1963|096|P|allergic reactions or other problems. Talk to your pharmacist for||
1963|097|P|more details.||
1963|098|P|   Before using this medication, tell your doctor or pharmacist||
1963|099|P|your medical history, especially of: liver problems.||
1963|100|P|   This medication may make you more sensitive to the sun. Limit||
1963|101|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1963|102|P|sunscreen and wear protective clothing when outdoors. Tell your||
1963|103|P|doctor right away if you get sunburned or have skin||
1963|104|P|blisters/redness.||
1963|105|P|   Eravacycline may cause live bacterial vaccines (such as||
1963|106|P|typhoid vaccine) to not work well. Tell your health care||
1963|107|P|professional that you are using eravacycline before having any||
1963|108|P|immunizations/vaccinations.||
1963|109|P|   Before having surgery, tell your doctor or dentist about all||
1963|110|P|the products you use (including prescription drugs,||
1963|111|P|nonprescription drugs, and herbal products).||
1963|112|P|   Tell your doctor if you are pregnant or plan to become||
1963|113|P|pregnant. You should not become pregnant while using||
1963|114|P|eravacycline. Eravacycline may harm an unborn baby. If you become||
1963|115|P|pregnant, talk to your doctor right away about the risks and||
1963|116|P|benefits of this medication.||
1963|117|P|   It is unknown if this medication passes into breast milk.||
1963|118|P|Consult your doctor before breastfeeding.||
1963|119|B|||
1963|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1963|121|I|medications work or increase your risk for serious side effects.||
1963|122|I|This document does not contain all possible drug interactions.||
1963|123|I|Keep a list of all the products you use (including||
1963|124|I|prescription/nonprescription drugs and herbal products) and share||
1963|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1963|126|I|the dosage of any medicines without your doctor's approval.||
1963|127|I|   Some products that may interact with this drug are: retinoid||
1963|128|I|medications taken by mouth (such as acitretin, isotretinoin).||
1963|129|I|   This medication may interfere with certain lab tests (such as||
1963|130|I|urine catecholamine levels), possibly causing false test results.||
1963|131|I|Make sure lab personnel and all your doctors know you use this||
1963|132|I|drug.||
1963|133|B|||
1963|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1963|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1963|136|O|poison control center right away. US residents can call||
1963|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1963|138|B|||
1963|139|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1963|140|N|kidney/liver function) may be done while you are using this||
1963|141|N|medication. Keep all medical and lab appointments.||
1963|142|B|||
1963|143|D|MISSED DOSE:  It is important to get each dose of this medication||
1963|144|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1963|145|D|right away for a new dosing schedule. Do not double the dose to||
1963|146|D|catch up.||
1963|147|B|||
1963|148|R|STORAGE:  Consult the product instructions or your pharmacist for||
1963|149|R|storage details. Keep all medications away from children and||
1963|150|R|pets.||
1963|151|R|   Do not flush medications down the toilet or pour them into a||
1963|152|R|drain unless instructed to do so. Properly discard this product||
1963|153|R|when it is expired or no longer needed. Consult your pharmacist||
1963|154|R|or local waste disposal company.||
1963|155|B|||
1963|156|A|Information last revised December 2024.||
1963|157|A|Copyright(c) 2025 First Databank, Inc.||
1963|158|B|||
1964|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1964|002|Z|does NOT have all possible information about this product. This||
1964|003|Z|information does not assure that this product is safe, effective,||
1964|004|Z|or appropriate for you. This information is not individual||
1964|005|Z|medical advice and does not substitute for the advice of your||
1964|006|Z|health care professional. Always ask your health care||
1964|007|Z|professional for complete information about this product and your||
1964|008|Z|specific health needs.||
1964|009|B|||
1964|010|T|DUVELISIB - ORAL||
1964|011|F|(DOO-ve-LIS-ib)||
1964|012|B|||
1964|013|C|COMMON BRAND NAME(S): Copiktra||
1964|014|B|||
1964|015|W|WARNING:  This medication may increase your risk of death,||
1964|016|W|especially due to an infection. Talk to your doctor about the||
1964|017|W|risks and benefits of this medication.||
1964|018|W|   This medication may lower your ability to fight infections.||
1964|019|W|This may make you more likely to get a serious (rarely fatal)||
1964|020|W|infection or make any infection you have worse. Get medical help||
1964|021|W|right away if you have any signs of infection (such as sore||
1964|022|W|throat that doesn't go away, fever, swollen lymph nodes, chills).||
1964|023|W|   This medication has caused serious (rarely fatal) bowel||
1964|024|W|problems (such as diarrhea, colitis). Tell your doctor right away||
1964|025|W|if you have new or worsening diarrhea, or stool with blood/mucus.||
1964|026|W|   Duvelisib can commonly cause a rash that is usually not||
1964|027|W|serious. However, you may not be able to tell it apart from a||
1964|028|W|rare rash that could be a sign of a severe reaction. Get medical||
1964|029|W|help right away if you develop any rash.||
1964|030|W|   This medication can cause serious (rarely fatal) inflammation||
1964|031|W|of your lungs. Tell your doctor right away if you develop new or||
1964|032|W|worsening cough or trouble breathing.||
1964|033|B|||
1964|034|U|USES:  This medication is used to treat certain types of cancer||
1964|035|U|(such as chronic lymphocytic leukemia, small lymphocytic||
1964|036|U|lymphoma). Duvelisib belongs to a class of drugs known as kinase||
1964|037|U|inhibitors. It works by slowing or stopping the growth of cancer||
1964|038|U|cells.||
1964|039|B|||
1964|040|H|HOW TO USE:  Read the Medication Guide provided by your||
1964|041|H|pharmacist before you start taking duvelisib and each time you||
1964|042|H|get a refill. If you have any questions, ask your doctor or||
1964|043|H|pharmacist.||
1964|044|H|   Take this medication by mouth with or without food as directed||
1964|045|H|by your doctor, usually 2 times daily. Swallow the capsules||
1964|046|H|whole. Do not open, break, or chew the capsules.||
1964|047|H|   The dosage is based on your medical condition, response to||
1964|048|H|treatment, and other medications you may be taking. Be sure to||
1964|049|H|tell your doctor and pharmacist about all the products you use||
1964|050|H|(including prescription/nonprescription drugs and herbal||
1964|051|H|products).||
1964|052|H|   Use this medication regularly to get the most benefit from it.||
1964|053|H|To help you remember, take it at the same times each day.||
1964|054|H|   Do not increase your dose or use this drug more often or for||
1964|055|H|longer than prescribed. Your condition will not improve any||
1964|056|H|faster, and your risk of serious side effects will increase. Your||
1964|057|H|doctor may direct you to temporarily stop or reduce your dose if||
1964|058|H|you have side effects. Your doctor may also prescribe other||
1964|059|H|medications to help prevent certain serious side effects.||
1964|060|H|Carefully follow your doctor's directions for all your||
1964|061|H|medications.||
1964|062|H|   Since this drug can be absorbed through the skin and lungs and||
1964|063|H|may harm an unborn baby, women who are pregnant or who may become||
1964|064|H|pregnant should not handle this medication or breathe the dust||
1964|065|H|from the capsules.||
1964|066|B|||
1964|067|S|SIDE EFFECTS:  See also Warning section.||
1964|068|S|   Diarrhea, nausea, vomiting, abdominal pain, muscle/joint pain,||
1964|069|S|or tiredness may occur. If any of these effects last or get||
1964|070|S|worse, tell your doctor or pharmacist promptly.||
1964|071|S|   Pain or sores in the mouth and throat may occur. Brush your||
1964|072|S|teeth carefully/gently, avoid using mouthwash that contains||
1964|073|S|alcohol, and rinse your mouth often with cool water mixed with||
1964|074|S|baking soda or salt. It may also be best to eat soft, moist||
1964|075|S|foods.||
1964|076|S|   People using this medication may have serious side effects.||
1964|077|S|However, you have been prescribed this drug because your doctor||
1964|078|S|has judged that the benefit to you is greater than the risk of||
1964|079|S|side effects. Careful monitoring by your doctor may decrease your||
1964|080|S|risk.||
1964|081|S|   Tell your doctor right away if you have any serious side||
1964|082|S|effects, including: easy bruising/bleeding, signs of liver damage||
1964|083|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
1964|084|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1964|085|S|   A very serious allergic reaction to this drug is rare.||
1964|086|S|However, get medical help right away if you notice any symptoms||
1964|087|S|of a serious allergic reaction, including: rash, itching/swelling||
1964|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1964|089|S|breathing.||
1964|090|S|   This is not a complete list of possible side effects. If you||
1964|091|S|notice other effects not listed above, contact your doctor or||
1964|092|S|pharmacist.||
1964|093|S|   In the US -||
1964|094|S|   Call your doctor for medical advice about side effects. You||
1964|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1964|096|S|www.fda.gov/medwatch.||
1964|097|S|   In Canada - Call your doctor for medical advice about side||
1964|098|S|effects. You may report side effects to Health Canada at||
1964|099|S|1-866-234-2345.||
1964|100|B|||
1964|101|P|PRECAUTIONS:  Before taking duvelisib, tell your doctor or||
1964|102|P|pharmacist if you are allergic to it; or if you have any other||
1964|103|P|allergies. This product may contain inactive ingredients, which||
1964|104|P|can cause allergic reactions or other problems. Talk to your||
1964|105|P|pharmacist for more details.||
1964|106|P|   Before using this medication, tell your doctor or pharmacist||
1964|107|P|your medical history, especially of: recent/current infection.||
1964|108|P|   Duvelisib can make you more likely to get infections or may||
1964|109|P|make current infections worse. Stay away from anyone who has an||
1964|110|P|infection that may easily spread (such as chickenpox, COVID-19,||
1964|111|P|measles, flu). Talk to your doctor if you have been exposed to an||
1964|112|P|infection or for more details.||
1964|113|P|   Tell your health care professional that you are using||
1964|114|P|duvelisib before having any immunizations/vaccinations. Avoid||
1964|115|P|contact with people who have recently received live vaccines||
1964|116|P|(such as flu vaccine inhaled through the nose).||
1964|117|P|   To lower the chance of getting cut, bruised, or injured, use||
1964|118|P|caution with sharp objects like razors and nail cutters, and||
1964|119|P|avoid activities such as contact sports.||
1964|120|P|   Before having surgery, tell your doctor or dentist about all||
1964|121|P|the products you use (including prescription drugs,||
1964|122|P|nonprescription drugs, and herbal products).||
1964|123|P|   Tell your doctor if you are pregnant or plan to become||
1964|124|P|pregnant. You should not become pregnant while using duvelisib.||
1964|125|P|Duvelisib may harm an unborn baby. Your doctor should order a||
1964|126|P|pregnancy test before you start this medication. Men and women||
1964|127|P|using this medication should ask about reliable forms of birth||
1964|128|P|control during treatment and for at least 1 month after the last||
1964|129|P|dose. If you or your partner becomes pregnant, talk to your||
1964|130|P|doctor right away about the risks and benefits of this||
1964|131|P|medication.||
1964|132|P|   Since this drug can be absorbed through the skin and lungs and||
1964|133|P|may harm an unborn baby, women who are pregnant or who may become||
1964|134|P|pregnant should not handle this medication or breathe the dust||
1964|135|P|from the capsules.||
1964|136|P|   It is unknown if this drug passes into breast milk. Because of||
1964|137|P|the possible risk to the infant, breastfeeding is not recommended||
1964|138|P|while using this drug and for at least 1 month after the last||
1964|139|P|dose. Consult your doctor before breastfeeding.||
1964|140|B|||
1964|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1964|142|I|medications work or increase your risk for serious side effects.||
1964|143|I|This document does not contain all possible drug interactions.||
1964|144|I|Keep a list of all the products you use (including||
1964|145|I|prescription/nonprescription drugs and herbal products) and share||
1964|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
1964|147|I|the dosage of any medicines without your doctor's approval.||
1964|148|I|   Other medications can affect the removal of duvelisib from||
1964|149|I|your body, which may affect how duvelisib works. Examples include||
1964|150|I|azole antifungals (such as itraconazole, ketoconazole),||
1964|151|I|apalutamide, enzalutamide, mitotane, rifamycins (such as||
1964|152|I|rifampin/rifabutin), St. John's wort, some drugs used to treat||
1964|153|I|seizures (such as carbamazepine, phenobarbital, phenytoin), among||
1964|154|I|others.||
1964|155|I|   This medication can slow down the removal of other medications||
1964|156|I|from your body, which may affect how they work. Examples of||
1964|157|I|affected drugs include elacestrant, flibanserin, lomitapide,||
1964|158|I|among others.||
1964|159|B|||
1964|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1964|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1964|162|O|poison control center right away. US residents can call||
1964|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1964|164|B|||
1964|165|N|NOTES:  Do not share this medication with others.||
1964|166|N|   Lab and/or medical tests (such as complete blood count,||
1964|167|N|kidney/liver function) should be done while you are taking this||
1964|168|N|medication. Keep all medical and lab appointments.||
1964|169|B|||
1964|170|D|MISSED DOSE:  If you miss a dose , take it as soon as you||
1964|171|D|remember. If it is more than 6 hours after the missed dose, skip||
1964|172|D|the missed dose. Take your next dose at the regular time. Do not||
1964|173|D|double the dose to catch up.||
1964|174|B|||
1964|175|R|STORAGE:  Store at room temperature away from light and moisture.||
1964|176|R|Do not store in the bathroom. Keep all medications away from||
1964|177|R|children and pets.||
1964|178|R|   Do not flush medications down the toilet or pour them into a||
1964|179|R|drain unless instructed to do so. Properly discard this product||
1964|180|R|when it is expired or no longer needed. Consult your pharmacist||
1964|181|R|or local waste disposal company.||
1964|182|B|||
1964|183|M|MEDICAL ALERT:  Your condition can cause complications in a||
1964|184|M|medical emergency. For information about enrolling in MedicAlert,||
1964|185|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1964|186|B|||
1964|187|A|Information last revised April 2025.||
1964|188|A|Copyright(c) 2025 First Databank, Inc.||
1964|189|B|||
1965|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1965|002|Z|does NOT have all possible information about this product. This||
1965|003|Z|information does not assure that this product is safe, effective,||
1965|004|Z|or appropriate for you. This information is not individual||
1965|005|Z|medical advice and does not substitute for the advice of your||
1965|006|Z|health care professional. Always ask your health care||
1965|007|Z|professional for complete information about this product and your||
1965|008|Z|specific health needs.||
1965|009|B|||
1965|010|T|GALCANEZUMAB - SUBCUTANEOUS INJECTION||
1965|011|F|(GAL-ka-NEZ-ue-mab)||
1965|012|B|||
1965|013|C|COMMON BRAND NAME(S): Emgality||
1965|014|B|||
1965|015|U|USES:  This medication is used to help prevent migraine. It is||
1965|016|U|also used to treat a certain type of headache (episodic cluster||
1965|017|U|headache). Galcanezumab belongs to a class of drugs known as||
1965|018|U|monoclonal antibodies. This medication may work by changing the||
1965|019|U|amounts of certain natural substances in the brain. Using this||
1965|020|U|medication can help improve your ability to concentrate and do||
1965|021|U|your usual tasks.||
1965|022|B|||
1965|023|H|HOW TO USE:  Read the Patient Information Leaflet and||
1965|024|H|Instructions for Use provided by your pharmacist before you start||
1965|025|H|using galcanezumab and each time you get a refill. Ask your||
1965|026|H|health care professional how to prepare and use this medication.||
1965|027|H|If you have any questions, ask your doctor or pharmacist.||
1965|028|H|   Inject this medication under the skin as directed by your||
1965|029|H|doctor, usually once a month. The injection is given in the||
1965|030|H|thigh, abdomen, buttocks, or upper arm. The dosage is based on||
1965|031|H|your medical condition and response to treatment.||
1965|032|H|   Take the medication out of the refrigerator at least 30||
1965|033|H|minutes before you inject it to allow it to reach room||
1965|034|H|temperature. Do not warm up this medication any other way (for||
1965|035|H|example, do not heat it in the microwave, place it in hot water,||
1965|036|H|leave it in direct sunlight). Do not shake the medication. Before||
1965|037|H|using, check this product for particles or discoloration. If||
1965|038|H|either is present, do not use the liquid. Before injecting each||
1965|039|H|dose, clean the skin you are going to inject into (the injection||
1965|040|H|site) with rubbing alcohol. Change the injection site each time||
1965|041|H|to lessen injury under the skin. Do not inject into skin that is||
1965|042|H|tender, bruised, red, or hard, or into scars or stretch marks. To||
1965|043|H|lessen bruising, do not rub the injection site after a shot.||
1965|044|H|Learn how to store and discard medical supplies safely.||
1965|045|H|   For the prevention of migraine, use this medication regularly||
1965|046|H|to get the most benefit from it. For the treatment of cluster||
1965|047|H|headache, use this medication regularly during the cluster||
1965|048|H|period. To help you remember, mark your calendar with a reminder.||
1965|049|H|   Tell your doctor if your condition does not get better or if||
1965|050|H|it gets worse.||
1965|051|B|||
1965|052|S|SIDE EFFECTS:  Redness, pain, itching, or swelling at the||
1965|053|S|injection site may occur. If any of these effects last or get||
1965|054|S|worse, tell your doctor or pharmacist promptly.||
1965|055|S|   Remember that this medication has been prescribed because your||
1965|056|S|doctor has judged that the benefit to you is greater than the||
1965|057|S|risk of side effects. Many people using this medication do not||
1965|058|S|have serious side effects.||
1965|059|S|   This medication may raise your blood pressure. Check your||
1965|060|S|blood pressure regularly and tell your doctor if the results are||
1965|061|S|high. Your doctor may control your blood pressure with||
1965|062|S|medication.||
1965|063|S|   Tell your doctor right away if you have any serious side||
1965|064|S|effects, including: blue fingers/toes, cold hands/feet.||
1965|065|S|   A very serious allergic reaction to this drug is rare.||
1965|066|S|However, get medical help right away if you notice any symptoms||
1965|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1965|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1965|069|S|breathing.||
1965|070|S|   This is not a complete list of possible side effects. If you||
1965|071|S|notice other effects not listed above, contact your doctor or||
1965|072|S|pharmacist.||
1965|073|S|   In the US -||
1965|074|S|   Call your doctor for medical advice about side effects. You||
1965|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1965|076|S|www.fda.gov/medwatch.||
1965|077|S|   In Canada - Call your doctor for medical advice about side||
1965|078|S|effects. You may report side effects to Health Canada at||
1965|079|S|1-866-234-2345.||
1965|080|B|||
1965|081|P|PRECAUTIONS:  Before using galcanezumab, tell your doctor or||
1965|082|P|pharmacist if you are allergic to it; or if you have any other||
1965|083|P|allergies. This product may contain inactive ingredients, which||
1965|084|P|can cause allergic reactions or other problems. Talk to your||
1965|085|P|pharmacist for more details.||
1965|086|P|   Before using this medication, tell your doctor or pharmacist||
1965|087|P|your medical history, especially of: blood circulation problems||
1965|088|P|(such as Raynaud's disease), high blood pressure.||
1965|089|P|   Before having surgery, tell your doctor or dentist about all||
1965|090|P|the products you use (including prescription drugs,||
1965|091|P|nonprescription drugs, and herbal products).||
1965|092|P|   During pregnancy, this medication should be used only when||
1965|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
1965|094|P|   It is unknown if this medication passes into breast milk.||
1965|095|P|Consult your doctor before breastfeeding.||
1965|096|B|||
1965|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1965|098|I|medications work or increase your risk for serious side effects.||
1965|099|I|This document does not contain all possible drug interactions.||
1965|100|I|Keep a list of all the products you use (including||
1965|101|I|prescription/nonprescription drugs and herbal products) and share||
1965|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
1965|103|I|the dosage of any medicines without your doctor's approval.||
1965|104|B|||
1965|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1965|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1965|107|O|poison control center right away. US residents can call||
1965|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1965|109|B|||
1965|110|N|NOTES:  Do not share this medication with others.||
1965|111|N|   Lab and/or medical tests (such as blood pressure) may be done||
1965|112|N|while you are using this medication. Keep all medical and lab||
1965|113|N|appointments. Consult your doctor for more details.||
1965|114|B|||
1965|115|D|MISSED DOSE:  If you miss a scheduled monthly dose, use it as||
1965|116|D|soon as you remember. Do not double the dose to catch up. Then||
1965|117|D|use your next dose one month later. Continue to use each dose one||
1965|118|D|month apart. Ask your doctor or pharmacist if you have questions||
1965|119|D|about your schedule.||
1965|120|B|||
1965|121|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1965|122|R|medication in the original packaging to protect from light. This||
1965|123|R|medication may also be stored at room temperature if needed. If||
1965|124|R|the medication is stored at room temperature, do not put it back||
1965|125|R|in the refrigerator and discard after 7 days. Do not leave the||
1965|126|R|syringe/autoinjector in direct sunlight. Keep all medications||
1965|127|R|away from children and pets.||
1965|128|R|   Do not flush medications down the toilet or pour them into a||
1965|129|R|drain unless instructed to do so. Properly discard this product||
1965|130|R|when it is expired or no longer needed. Consult your pharmacist||
1965|131|R|or local waste disposal company.||
1965|132|B|||
1965|133|A|Information last revised March 2025.||
1965|134|A|Copyright(c) 2025 First Databank, Inc.||
1965|135|B|||
1966|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1966|002|Z|does NOT have all possible information about this product. This||
1966|003|Z|information does not assure that this product is safe, effective,||
1966|004|Z|or appropriate for you. This information is not individual||
1966|005|Z|medical advice and does not substitute for the advice of your||
1966|006|Z|health care professional. Always ask your health care||
1966|007|Z|professional for complete information about this product and your||
1966|008|Z|specific health needs.||
1966|009|B|||
1966|010|T|CEMIPLIMAB - INJECTION||
1966|011|F|(sem-IP-li-mab)||
1966|012|B|||
1966|013|C|COMMON BRAND NAME(S): Libtayo||
1966|014|B|||
1966|015|U|USES:  Cemiplimab is used to treat certain types of cancer (such||
1966|016|U|as skin, lung). It works by changing the action of your own||
1966|017|U|immune system, directing it to attack cancer cells. Cemiplimab||
1966|018|U|belongs to a class of drugs known as monoclonal antibodies.||
1966|019|B|||
1966|020|H|HOW TO USE:  Read the Medication Guide provided by your||
1966|021|H|pharmacist before you start receiving cemiplimab and each time||
1966|022|H|you get a treatment. If you have any questions, ask your doctor||
1966|023|H|or pharmacist.||
1966|024|H|   This medication is given by a health care professional. It is||
1966|025|H|injected slowly into a vein over 30 minutes. It is given as||
1966|026|H|directed by your doctor, usually once every 3 or 6 weeks.||
1966|027|H|   Infusion reactions may happen during the infusion of this||
1966|028|H|drug. Your doctor may prescribe another medication (a||
1966|029|H|corticosteroid such as prednisone) to help prevent these side||
1966|030|H|effects. Tell your doctor right away if you have any symptoms of||
1966|031|H|infusion reactions such as nausea, vomiting, fever, or dizziness.||
1966|032|H|Your doctor may slow down or stop your infusion.||
1966|033|H|   Use this medication regularly to get the most benefit from it.||
1966|034|H|To help you remember, mark your calendar with a reminder.||
1966|035|B|||
1966|036|S|SIDE EFFECTS:  See also How to Use section.||
1966|037|S|   Diarrhea, nausea, or decreased appetite may occur. If any of||
1966|038|S|these effects last or get worse, tell your doctor or pharmacist||
1966|039|S|promptly.||
1966|040|S|   People using this medication may have serious side effects.||
1966|041|S|However, you have been prescribed this drug because your doctor||
1966|042|S|has judged that the benefit to you is greater than the risk of||
1966|043|S|side effects. Careful monitoring by your doctor may decrease your||
1966|044|S|risk.||
1966|045|S|   Tell your doctor right away if you have any serious side||
1966|046|S|effects, including: new/worsening cough, diarrhea with||
1966|047|S|blood/mucus, severe stomach/abdominal pain, mouth/throat sores,||
1966|048|S|symptoms of liver disease (such as nausea/vomiting that doesn't||
1966|049|S|stop, loss of appetite, yellowing eyes/skin, dark urine), signs||
1966|050|S|of kidney problems (such as change in the amount of urine,||
1966|051|S|pink/bloody urine), easy bruising/bleeding, swelling||
1966|052|S|hands/ankles/feet, unusual weakness, joint stiffness/pain, muscle||
1966|053|S|weakness/tenderness/pain/spasms/cramps, numbness/tingling of||
1966|054|S|arms/legs, loss of coordination, eye redness/pain, sensitivity to||
1966|055|S|light, vision changes, headache that is unusual or doesn't go||
1966|056|S|away, seizures.||
1966|057|S|   Cemiplimab may cause hormone gland problems (such as thyroid,||
1966|058|S|pituitary, adrenal, pancreas). Your body could make too much or||
1966|059|S|too little hormone. Tell your doctor right away if you have any||
1966|060|S|symptoms such as: cold or heat intolerance, unexplained weight||
1966|061|S|loss/gain, increased thirst/urination, mood or behavior changes||
1966|062|S|(such as decreased sex drive, irritability, forgetfulness),||
1966|063|S|slow/fast/pounding/irregular heartbeat, unusual tiredness,||
1966|064|S|constipation.||
1966|065|S|   Get medical help right away if you have any very serious side||
1966|066|S|effects, including: chest pain, shortness of breath.||
1966|067|S|   Cemiplimab can commonly cause itching or a rash that is||
1966|068|S|usually not serious. However, you may not be able to tell it||
1966|069|S|apart from a rare rash that could be a sign of a severe reaction.||
1966|070|S|Get medical help right away if you develop any rash or itching.||
1966|071|S|   A very serious allergic reaction to this drug is rare.||
1966|072|S|However, get medical help right away if you notice any symptoms||
1966|073|S|of a serious allergic reaction, including: fever, swollen lymph||
1966|074|S|nodes, rash, itching/swelling (especially of the||
1966|075|S|face/tongue/throat), severe dizziness, trouble breathing.||
1966|076|S|   This is not a complete list of possible side effects. If you||
1966|077|S|notice other effects not listed above, contact your doctor or||
1966|078|S|pharmacist.||
1966|079|S|   In the US -||
1966|080|S|   Call your doctor for medical advice about side effects. You||
1966|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1966|082|S|www.fda.gov/medwatch.||
1966|083|S|   In Canada - Call your doctor for medical advice about side||
1966|084|S|effects. You may report side effects to Health Canada at||
1966|085|S|1-866-234-2345.||
1966|086|B|||
1966|087|P|PRECAUTIONS:  Before using cemiplimab, tell your doctor or||
1966|088|P|pharmacist if you are allergic to it; or if you have any other||
1966|089|P|allergies. This product may contain inactive ingredients, which||
1966|090|P|can cause allergic reactions or other problems. Talk to your||
1966|091|P|pharmacist for more details.||
1966|092|P|   Before using this medication, tell your doctor or pharmacist||
1966|093|P|your medical history, especially of: organ/tissue transplant,||
1966|094|P|stem cell transplant with donor cells.||
1966|095|P|   Before having surgery, tell your doctor or dentist about all||
1966|096|P|the products you use (including prescription drugs,||
1966|097|P|nonprescription drugs, and herbal products).||
1966|098|P|   Tell your doctor if you are pregnant or plan to become||
1966|099|P|pregnant. You should not become pregnant while using cemiplimab.||
1966|100|P|Cemiplimab may harm an unborn baby. Ask about reliable forms of||
1966|101|P|birth control while using this medication and for 4 months after||
1966|102|P|the last dose. If you become pregnant, talk to your doctor right||
1966|103|P|away about the risks and benefits of this medication.||
1966|104|P|   It is unknown if this drug passes into breast milk. Because of||
1966|105|P|the possible risk to the infant, breastfeeding is not recommended||
1966|106|P|while using this drug and for 4 months after the last dose.||
1966|107|P|Consult your doctor before breastfeeding.||
1966|108|B|||
1966|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1966|110|I|medications work or increase your risk for serious side effects.||
1966|111|I|This document does not contain all possible drug interactions.||
1966|112|I|Keep a list of all the products you use (including||
1966|113|I|prescription/nonprescription drugs and herbal products) and share||
1966|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
1966|115|I|the dosage of any medicines without your doctor's approval.||
1966|116|B|||
1966|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1966|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1966|119|O|poison control center right away. US residents can call||
1966|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1966|121|B|||
1966|122|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
1966|123|N|function, blood sugar) should be done before and during treatment||
1966|124|N|with this medication. Keep all medical and lab appointments.||
1966|125|N|Consult your doctor for more details.||
1966|126|B|||
1966|127|D|MISSED DOSE:  It is important to get each dose of this medication||
1966|128|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1966|129|D|right away for a new dosing schedule.||
1966|130|B|||
1966|131|R|STORAGE:  Not applicable. This medication is given in a hospital||
1966|132|R|or clinic and will not be stored at home.||
1966|133|B|||
1966|134|A|Information last revised October 2025.||
1966|135|A|Copyright(c) 2025 First Databank, Inc.||
1966|136|B|||
1967|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1967|002|Z|does NOT have all possible information about this product. This||
1967|003|Z|information does not assure that this product is safe, effective,||
1967|004|Z|or appropriate for you. This information is not individual||
1967|005|Z|medical advice and does not substitute for the advice of your||
1967|006|Z|health care professional. Always ask your health care||
1967|007|Z|professional for complete information about this product and your||
1967|008|Z|specific health needs.||
1967|009|B|||
1967|010|T|CANNABIDIOL SOLUTION - ORAL||
1967|011|F|(KAN-a-bi-DYE-ol)||
1967|012|B|||
1967|013|C|COMMON BRAND NAME(S): Epidiolex||
1967|014|B|||
1967|015|U|USES:  This medication is used to treat seizures due to certain||
1967|016|U|medical conditions (such as Lennox-Gastaut syndrome, Dravet||
1967|017|U|syndrome, tuberous sclerosis complex - TSC). It is not known how||
1967|018|U|this medication works for these seizures. Cannabidiol belongs to||
1967|019|U|a class of drugs known as cannabinoids.||
1967|020|B|||
1967|021|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1967|022|H|provided by your pharmacist before you start taking cannabidiol||
1967|023|H|and each time you get a refill. If you have any questions, ask||
1967|024|H|your doctor or pharmacist.||
1967|025|H|   Take this medication by mouth as directed by your doctor,||
1967|026|H|usually twice daily. You may take this medication with or without||
1967|027|H|food, but it is important to choose one way and take this||
1967|028|H|medication the same way with every dose. The dosage is based on||
1967|029|H|your medical condition, weight, response to treatment, and other||
1967|030|H|medications you may be taking. Be sure to tell your doctor and||
1967|031|H|pharmacist about all the products you use (including prescription||
1967|032|H|drugs, nonprescription drugs, and herbal products).||
1967|033|H|   To reduce your risk of side effects, your doctor may direct||
1967|034|H|you to start this medication at a low dose and gradually increase||
1967|035|H|your dose. Also, if you are directed to stop taking this||
1967|036|H|medication, your doctor may decrease your dose gradually. Follow||
1967|037|H|your doctor's instructions carefully.||
1967|038|H|   Carefully measure the dose using a special measuring||
1967|039|H|device/spoon. Do not use a household spoon because you may not||
1967|040|H|get the correct dose.||
1967|041|H|   Take this medication regularly to get the most benefit from||
1967|042|H|it. To help you remember, take it at the same times each day.||
1967|043|H|   Tell your doctor if your condition does not get better or if||
1967|044|H|it gets worse.||
1967|045|B|||
1967|046|S|SIDE EFFECTS:  Drowsiness, tiredness, trouble sleeping, unusual||
1967|047|S|lack of energy, decreased appetite, decreased weight, or diarrhea||
1967|048|S|may occur. If any of these effects last or get worse, tell your||
1967|049|S|doctor or pharmacist promptly.||
1967|050|S|   Remember that this medication has been prescribed because your||
1967|051|S|doctor has judged that the benefit to you is greater than the||
1967|052|S|risk of side effects. Many people using this medication do not||
1967|053|S|have serious side effects.||
1967|054|S|   Tell your doctor right away if you have any serious side||
1967|055|S|effects, including: signs of liver damage (such as||
1967|056|S|nausea/vomiting that doesn't stop, loss of appetite,||
1967|057|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
1967|058|S|of infection (such as sore throat that doesn't go away, fever,||
1967|059|S|chills).||
1967|060|S|   A small number of people who take anti-seizure drugs for any||
1967|061|S|condition (such as seizure, bipolar disorder, pain) may||
1967|062|S|experience depression, suicidal thoughts/attempts, or other||
1967|063|S|mental/mood problems. Tell your doctor right away if you or your||
1967|064|S|family/caregiver notice any unusual/sudden changes in your mood,||
1967|065|S|thoughts, or behavior such as irritability, signs of depression,||
1967|066|S|suicidal thoughts/attempts, thoughts about harming yourself.||
1967|067|S|   A very serious allergic reaction to this drug is rare.||
1967|068|S|However, get medical help right away if you notice any symptoms||
1967|069|S|of a serious allergic reaction, including: rash, itching/swelling||
1967|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1967|071|S|breathing.||
1967|072|S|   This is not a complete list of possible side effects. If you||
1967|073|S|notice other effects not listed above, contact your doctor or||
1967|074|S|pharmacist.||
1967|075|S|   In the US -||
1967|076|S|   Call your doctor for medical advice about side effects. You||
1967|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1967|078|S|www.fda.gov/medwatch.||
1967|079|S|   In Canada - Call your doctor for medical advice about side||
1967|080|S|effects. You may report side effects to Health Canada at||
1967|081|S|1-866-234-2345.||
1967|082|B|||
1967|083|P|PRECAUTIONS:  Before taking cannabidiol, tell your doctor or||
1967|084|P|pharmacist if you are allergic to it; or if you have any other||
1967|085|P|allergies. This product may contain inactive ingredients (such as||
1967|086|P|sesame seed oil), which can cause allergic reactions or other||
1967|087|P|problems. Talk to your pharmacist for more details.||
1967|088|P|   Before taking this medication, tell your doctor or pharmacist||
1967|089|P|your medical history, especially of: liver problems, mental/mood||
1967|090|P|problems (such as anxiety, depression, thoughts of suicide),||
1967|091|P|personal or family history of a substance use disorder (such as||
1967|092|P|overuse of or addiction to drugs/alcohol).||
1967|093|P|   This drug may make you drowsy. Alcohol or marijuana can make||
1967|094|P|you more drowsy. Do not drive, use machinery, or do anything that||
1967|095|P|needs alertness until you can do it safely. Avoid alcoholic||
1967|096|P|beverages. Talk to your doctor if you are using marijuana.||
1967|097|P|   This medication may contain sugar, aspartame, or alcohol.||
1967|098|P|Caution is advised if you have diabetes, liver disease,||
1967|099|P|phenylketonuria (PKU), or any other condition that requires you||
1967|100|P|to limit/avoid these substances in your diet. Ask your doctor or||
1967|101|P|pharmacist about taking this medication safely.||
1967|102|P|   Before having surgery, tell your doctor or dentist about all||
1967|103|P|the products you use (including prescription drugs,||
1967|104|P|nonprescription drugs, and herbal products).||
1967|105|P|   During pregnancy, this medication should be used only when||
1967|106|P|clearly needed. However, since untreated seizures are a serious||
1967|107|P|condition that can harm both a pregnant woman and her unborn||
1967|108|P|baby, do not stop taking this medication unless directed by your||
1967|109|P|doctor. If you are planning pregnancy, become pregnant, or think||
1967|110|P|you may be pregnant, talk to your doctor right away about the||
1967|111|P|benefits and risks of taking this medication during pregnancy.||
1967|112|P|   It is unknown if this medication passes into breast milk.||
1967|113|P|Consult your doctor before breastfeeding.||
1967|114|B|||
1967|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1967|116|I|medications work or increase your risk for serious side effects.||
1967|117|I|This document does not contain all possible drug interactions.||
1967|118|I|Keep a list of all the products you use (including||
1967|119|I|prescription/nonprescription drugs and herbal products) and share||
1967|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
1967|121|I|the dosage of any medicines without your doctor's approval.||
1967|122|I|   This medication can slow down the removal of other medications||
1967|123|I|from your body, which may affect how they work. An example of an||
1967|124|I|affected drug is fezolinetant, among others.||
1967|125|I|   Tell your doctor or pharmacist if you are taking other||
1967|126|I|products that cause drowsiness such as opioid pain or cough||
1967|127|I|relievers (such as codeine, hydrocodone), alcohol, marijuana,||
1967|128|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
1967|129|I|zolpidem), muscle relaxants (such as carisoprodol,||
1967|130|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1967|131|I|diphenhydramine).||
1967|132|I|   Check the labels on all your medicines (such as allergy or||
1967|133|I|cough-and-cold products) because they may contain ingredients||
1967|134|I|that cause drowsiness. Ask your pharmacist about using those||
1967|135|I|products safely.||
1967|136|I|   This medication may affect certain lab test results (such as||
1967|137|I|cannabis drug screening). Make sure lab personnel and all your||
1967|138|I|doctors know you take this drug.||
1967|139|B|||
1967|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1967|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1967|142|O|poison control center right away. US residents can call||
1967|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1967|144|B|||
1967|145|N|NOTES:  Do not share this medication with others.||
1967|146|N|   Lab and/or medical tests (such as liver function) should be||
1967|147|N|done before you start taking this medication and while you are||
1967|148|N|taking it. Keep all medical and lab appointments.||
1967|149|B|||
1967|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1967|151|D|remember. If it is near the time of the next dose, skip the||
1967|152|D|missed dose. Take your next dose at the regular time. Do not||
1967|153|D|double the dose to catch up.||
1967|154|B|||
1967|155|R|STORAGE:  Store in the original bottle at room temperature. Do||
1967|156|R|not freeze. Keep the bottle in an upright position. Tightly close||
1967|157|R|the bottle when not in use. Once the bottle is opened, this||
1967|158|R|medication expires after 12 weeks. Keep all medications away from||
1967|159|R|children and pets.||
1967|160|R|   Do not flush medications down the toilet or pour them into a||
1967|161|R|drain unless instructed to do so. Properly discard this product||
1967|162|R|when it is expired or no longer needed. Consult your pharmacist||
1967|163|R|or local waste disposal company.||
1967|164|B|||
1967|165|M|MEDICAL ALERT:  Your condition can cause complications in a||
1967|166|M|medical emergency. For information about enrolling in MedicAlert,||
1967|167|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1967|168|B|||
1967|169|A|Information last revised July 2025.||
1967|170|A|Copyright(c) 2025 First Databank, Inc.||
1967|171|B|||
1968|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1968|002|Z|does NOT have all possible information about this product. This||
1968|003|Z|information does not assure that this product is safe, effective,||
1968|004|Z|or appropriate for you. This information is not individual||
1968|005|Z|medical advice and does not substitute for the advice of your||
1968|006|Z|health care professional. Always ask your health care||
1968|007|Z|professional for complete information about this product and your||
1968|008|Z|specific health needs.||
1968|009|B|||
1968|010|T|DACOMITINIB - ORAL||
1968|011|F|(DAK-oh-MI-ti-nib)||
1968|012|B|||
1968|013|C|COMMON BRAND NAME(S): Vizimpro||
1968|014|B|||
1968|015|U|USES:  Dacomitinib is used to treat a certain type of lung cancer||
1968|016|U|(non-small cell lung cancer). It works by slowing or stopping the||
1968|017|U|growth of cancer cells.||
1968|018|B|||
1968|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1968|020|H|from your pharmacist before you start taking dacomitinib and each||
1968|021|H|time you get a refill. If you have any questions, ask your doctor||
1968|022|H|or pharmacist.||
1968|023|H|   Take this medication by mouth with or without food as directed||
1968|024|H|by your doctor, usually once daily.||
1968|025|H|   Take this medication regularly to get the most benefit from||
1968|026|H|it. To help you remember, take it at the same time each day.||
1968|027|H|   If you vomit up a dose, do not take another dose then. Take||
1968|028|H|your next dose at the regular time.||
1968|029|H|   The dosage is based on your medical condition and response to||
1968|030|H|treatment. Do not increase your dose or use this drug more often||
1968|031|H|or for longer than prescribed. Your condition will not improve||
1968|032|H|any faster, and your risk of serious side effects will increase.||
1968|033|H|   Certain medications that reduce stomach acid (proton pump||
1968|034|H|inhibitors/PPIs, H2 blockers) may make dacomitinib work less||
1968|035|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
1968|036|H|using this medication. If you take H2 blockers (such as||
1968|037|H|famotidine, nizatidine), take dacomitinib at least 6 hours before||
1968|038|H|or 10 hours after taking the H2 blocker.||
1968|039|B|||
1968|040|S|SIDE EFFECTS:  Mouth sores, decreased appetite, weight loss,||
1968|041|S|swelling/infection around your nails, or dry skin may occur. Use||
1968|042|S|a moisturizer for dry skin as soon as you start treatment with||
1968|043|S|this medication. If any of these effects last or get worse, tell||
1968|044|S|your doctor or pharmacist promptly.||
1968|045|S|   Temporary hair loss may occur. Normal hair growth should||
1968|046|S|return after treatment has ended.||
1968|047|S|   Remember that this medication has been prescribed because your||
1968|048|S|doctor has judged that the benefit to you is greater than the||
1968|049|S|risk of side effects. Many people using this medication do not||
1968|050|S|have serious side effects.||
1968|051|S|   Diarrhea is a common side effect. Drink plenty of fluids as||
1968|052|S|directed by your doctor to lessen your risk of dehydration. Your||
1968|053|S|doctor may prescribe anti-diarrhea medication (such as||
1968|054|S|loperamide) to control your symptoms. Tell your doctor right away||
1968|055|S|if you have: diarrhea that doesn't stop or is severe, signs of||
1968|056|S|dehydration (such as unusual decreased urination, unusual dry||
1968|057|S|mouth/thirst, fast heartbeat, dizziness/lightheadedness).||
1968|058|S|   Get medical help right away if you have any very serious side||
1968|059|S|effects, including: signs of a new/worsening lung problem (such||
1968|060|S|as shortness of breath, cough, fever).||
1968|061|S|   Dacomitinib can commonly cause a rash that is usually not||
1968|062|S|serious. However, you may not be able to tell it apart from a||
1968|063|S|rare rash that could be a sign of a severe reaction. Get medical||
1968|064|S|help right away if you develop any rash.||
1968|065|S|   A very serious allergic reaction to this drug is rare.||
1968|066|S|However, get medical help right away if you notice any symptoms||
1968|067|S|of a serious allergic reaction, including: rash, itching/swelling||
1968|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1968|069|S|breathing.||
1968|070|S|   This is not a complete list of possible side effects. If you||
1968|071|S|notice other effects not listed above, contact your doctor or||
1968|072|S|pharmacist.||
1968|073|S|   In the US -||
1968|074|S|   Call your doctor for medical advice about side effects. You||
1968|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1968|076|S|www.fda.gov/medwatch.||
1968|077|S|   In Canada - Call your doctor for medical advice about side||
1968|078|S|effects. You may report side effects to Health Canada at||
1968|079|S|1-866-234-2345.||
1968|080|B|||
1968|081|P|PRECAUTIONS:  Before taking dacomitinib, tell your doctor or||
1968|082|P|pharmacist if you are allergic to it; or if you have any other||
1968|083|P|allergies. This product may contain inactive ingredients, which||
1968|084|P|can cause allergic reactions or other problems. Talk to your||
1968|085|P|pharmacist for more details.||
1968|086|P|   Before using this medication, tell your doctor or pharmacist||
1968|087|P|your medical history.||
1968|088|P|   This medication may make you more sensitive to the sun. Limit||
1968|089|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1968|090|P|sunscreen and wear protective clothing when outdoors. Tell your||
1968|091|P|doctor right away if you get sunburned or have skin||
1968|092|P|blisters/redness.||
1968|093|P|   Before having surgery, tell your doctor or dentist about all||
1968|094|P|the products you use (including prescription drugs,||
1968|095|P|nonprescription drugs, and herbal products).||
1968|096|P|   Tell your doctor if you are pregnant or plan to become||
1968|097|P|pregnant. You should not become pregnant while using dacomitinib.||
1968|098|P|Dacomitinib may harm an unborn baby. Your doctor should order a||
1968|099|P|pregnancy test before you start this medication. Ask about||
1968|100|P|reliable forms of birth control while using this medication and||
1968|101|P|for at least 17 days after the last dose. If you become pregnant,||
1968|102|P|talk to your doctor right away about the risks and benefits of||
1968|103|P|this medication.||
1968|104|P|   It is unknown if this medication passes into breast milk.||
1968|105|P|Because of the possible risk to the infant, breastfeeding is not||
1968|106|P|recommended while using this medication and for at least 17 days||
1968|107|P|after the last dose. Consult your doctor before breastfeeding.||
1968|108|B|||
1968|109|I|DRUG INTERACTIONS:  See also How to Use section.||
1968|110|I|   Drug interactions may change how your medications work or||
1968|111|I|increase your risk for serious side effects. This document does||
1968|112|I|not contain all possible drug interactions. Keep a list of all||
1968|113|I|the products you use (including prescription/nonprescription||
1968|114|I|drugs and herbal products) and share it with your doctor and||
1968|115|I|pharmacist. Do not start, stop, or change the dosage of any||
1968|116|I|medicines without your doctor's approval.||
1968|117|I|   This medication can slow down the removal of other medications||
1968|118|I|from your body, which may affect how they work. Examples of||
1968|119|I|affected drugs include dextromethorphan, pimozide, thioridazine,||
1968|120|I|among others.||
1968|121|B|||
1968|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1968|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1968|124|O|poison control center right away. US residents can call||
1968|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1968|126|B|||
1968|127|N|NOTES:  Do not share this medication with others.||
1968|128|N|   Lab and/or medical tests may be done while you are taking this||
1968|129|N|medication. Keep all medical and lab appointments.||
1968|130|B|||
1968|131|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1968|132|D|next dose at the regular time. Do not double the dose to catch||
1968|133|D|up.||
1968|134|B|||
1968|135|R|STORAGE:  Store at room temperature away from light and moisture.||
1968|136|R|Do not store in the bathroom. Keep all medications away from||
1968|137|R|children and pets.||
1968|138|R|   Do not flush medications down the toilet or pour them into a||
1968|139|R|drain unless instructed to do so. Properly discard this product||
1968|140|R|when it is expired or no longer needed. Consult your pharmacist||
1968|141|R|or local waste disposal company.||
1968|142|B|||
1968|143|A|Information last revised June 2025.||
1968|144|A|Copyright(c) 2025 First Databank, Inc.||
1968|145|B|||
1969|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1969|002|Z|does NOT have all possible information about this product. This||
1969|003|Z|information does not assure that this product is safe, effective,||
1969|004|Z|or appropriate for you. This information is not individual||
1969|005|Z|medical advice and does not substitute for the advice of your||
1969|006|Z|health care professional. Always ask your health care||
1969|007|Z|professional for complete information about this product and your||
1969|008|Z|specific health needs.||
1969|009|B|||
1969|010|T|RIVAROXABAN 2.5 MG - ORAL||
1969|011|F|(RIV-a-ROX-a-ban)||
1969|012|B|||
1969|013|C|COMMON BRAND NAME(S): Xarelto||
1969|014|B|||
1969|015|W|WARNING:  Do not stop taking rivaroxaban unless directed by your||
1969|016|W|doctor. If you stop taking this medication early, you have a||
1969|017|W|higher risk of forming a serious blood clot (such as a stroke,||
1969|018|W|blood clot in the legs/lungs). Your doctor may direct you to take||
1969|019|W|a different "blood thinning" or antiplatelet medication to reduce||
1969|020|W|your risk. Get medical help right away if you have weakness on||
1969|021|W|one side of the body, trouble speaking, sudden vision changes,||
1969|022|W|confusion, chest pain, trouble breathing, or pain/warmth/swelling||
1969|023|W|in the legs.||
1969|024|W|   People taking this medication may bleed near the spinal cord||
1969|025|W|after certain spinal procedures. Bleeding in this area can cause||
1969|026|W|paralysis that lasts a long time or could become permanent.||
1969|027|W|Before any spinal procedure, ask your doctor about the benefits||
1969|028|W|and risks. The risk of bleeding may be higher if you have a||
1969|029|W|deformed spine, or have had spinal procedures/surgery before||
1969|030|W|(such as epidural catheter placement, difficult epidural/spinal||
1969|031|W|puncture), or are taking other drugs that can cause||
1969|032|W|bleeding/bruising (including antiplatelet drugs such as||
1969|033|W|clopidogrel, "blood thinners" such as warfarin/enoxaparin,||
1969|034|W|nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen).||
1969|035|W|Tell your doctor right away if you notice symptoms such as back||
1969|036|W|pain, leg numbness/tingling/weakness, loss of control of the||
1969|037|W|bowels or bladder (incontinence).||
1969|038|B|||
1969|039|U|USES:  Rivaroxaban is used along with low-dose aspirin to help||
1969|040|U|prevent heart attack, stroke, and death in people with a certain||
1969|041|U|heart problem (coronary artery disease - CAD) or in people who||
1969|042|U|have reduced blood flow to the arms/legs (peripheral artery||
1969|043|U|disease - PAD), including those people who recently had surgery||
1969|044|U|for PAD. For patients with PAD, this medication may also help||
1969|045|U|reduce the risk of blood vessel blockage to the hands/legs/feet||
1969|046|U|and reduce the risk of amputation.||
1969|047|U|   Rivaroxaban is an anticoagulant that works by blocking certain||
1969|048|U|clotting proteins in your blood.||
1969|049|B|||
1969|050|H|HOW TO USE:  Read the Medication Guide provided by your||
1969|051|H|pharmacist before you start taking rivaroxaban and each time you||
1969|052|H|get a refill. If you have any questions, ask your doctor or||
1969|053|H|pharmacist.||
1969|054|H|   Take this medication by mouth with or without food as directed||
1969|055|H|by your doctor, usually twice daily. Take a low-dose aspirin||
1969|056|H|(usually 75-100 milligrams) once a day as directed by your||
1969|057|H|doctor. Follow your doctor's directions carefully.||
1969|058|H|   If you are unable to swallow whole tablets, you may crush the||
1969|059|H|tablet and mix it with applesauce. Eat the entire mixture right||
1969|060|H|away. Do not prepare a supply for future use.||
1969|061|H|   If you are giving this medication through a tube into the||
1969|062|H|stomach (nasogastric or gastric tube), ask your health care||
1969|063|H|professional for detailed instructions on how to properly mix and||
1969|064|H|give it.||
1969|065|H|   Use this medication regularly to get the most benefit from it.||
1969|066|H|To help you remember, take it at the same times each day.||
1969|067|H|   Do not increase your dose or take this drug more often or for||
1969|068|H|longer than prescribed. Your condition will not improve any||
1969|069|H|faster, and your risk of side effects will increase.||
1969|070|B|||
1969|071|S|SIDE EFFECTS:  See also Warning section.||
1969|072|S|   Easy bruising or minor bleeding (such as nosebleed, bleeding||
1969|073|S|from cuts) may occur. If either of these effects lasts or gets||
1969|074|S|worse, tell your doctor or pharmacist promptly.||
1969|075|S|   Remember that this medication has been prescribed because your||
1969|076|S|doctor has judged that the benefit to you is greater than the||
1969|077|S|risk of side effects. Many people using this medication do not||
1969|078|S|have serious side effects.||
1969|079|S|   This medication can cause serious bleeding if it affects your||
1969|080|S|blood clotting proteins too much. Tell your doctor right away if||
1969|081|S|you have any signs of serious bleeding, including: nosebleeds||
1969|082|S|that happen often or don't stop, unusual tiredness/weakness,||
1969|083|S|unusual pain/swelling/discomfort, unusual bruising, prolonged||
1969|084|S|bleeding from cuts or gums, unusually heavy/prolonged menstrual||
1969|085|S|flow, pink/dark urine, coughing up blood, vomit that is bloody or||
1969|086|S|looks like coffee grounds, severe headache, dizziness/fainting,||
1969|087|S|bloody/black/tarry stools, difficulty swallowing.||
1969|088|S|   Get medical help right away if you have any signs of very||
1969|089|S|serious bleeding, including: vision changes, confusion, trouble||
1969|090|S|speaking, weakness on one side of the body, injury to the spleen||
1969|091|S|(such as stomach/abdominal pain, shoulder pain).||
1969|092|S|   A very serious allergic reaction to this drug is rare.||
1969|093|S|However, get medical help right away if you notice any symptoms||
1969|094|S|of a serious allergic reaction, including: rash, itching/swelling||
1969|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1969|096|S|breathing.||
1969|097|S|   This is not a complete list of possible side effects. If you||
1969|098|S|notice other effects not listed above, contact your doctor or||
1969|099|S|pharmacist.||
1969|100|S|   In the US -||
1969|101|S|   Call your doctor for medical advice about side effects. You||
1969|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1969|103|S|www.fda.gov/medwatch.||
1969|104|S|   In Canada - Call your doctor for medical advice about side||
1969|105|S|effects. You may report side effects to Health Canada at||
1969|106|S|1-866-234-2345.||
1969|107|B|||
1969|108|P|PRECAUTIONS:  Before taking rivaroxaban, tell your doctor or||
1969|109|P|pharmacist if you are allergic to it; or if you have any other||
1969|110|P|allergies. This product may contain inactive ingredients, which||
1969|111|P|can cause allergic reactions or other problems. Talk to your||
1969|112|P|pharmacist for more details.||
1969|113|P|   Before using this medication, tell your doctor or pharmacist||
1969|114|P|your medical history, especially of: cancer, liver disease,||
1969|115|P|kidney disease, bleeding problems (such as bleeding of the||
1969|116|P|stomach/intestines, bleeding in the brain), stroke, artificial||
1969|117|P|heart valves, recent major injury/surgery, blood disorders (such||
1969|118|P|as anemia, hemophilia, thrombocytopenia), frequent||
1969|119|P|falls/injuries, a certain eye problem (retinopathy), a certain||
1969|120|P|clotting disorder (antiphospholipid syndrome), certain hereditary||
1969|121|P|enzyme problems (such as galactose intolerance, Lapp lactase||
1969|122|P|deficiency, glucose-galactose malabsorption).||
1969|123|P|   Before having surgery or any medical/dental procedures||
1969|124|P|(especially spinal puncture or spinal/epidural anesthesia), tell||
1969|125|P|your doctor or dentist that you are taking this medication and||
1969|126|P|about all the products you use (including prescription drugs,||
1969|127|P|nonprescription drugs, and herbal products). Your doctor or||
1969|128|P|dentist may tell you to stop taking rivaroxaban before your||
1969|129|P|surgery. Ask for specific instructions about stopping or starting||
1969|130|P|this medication.||
1969|131|P|   This medication may cause stomach bleeding. Daily use of||
1969|132|P|alcohol while using this medicine may increase your risk for||
1969|133|P|stomach bleeding. Limit alcoholic beverages. Ask your doctor or||
1969|134|P|pharmacist about how much alcohol you may safely drink.||
1969|135|P|   This medication can cause heavy bleeding. To lower the chance||
1969|136|P|of getting cut, bruised, or injured, use caution with sharp||
1969|137|P|objects like razors and nail cutters, and avoid activities such||
1969|138|P|as contact sports. Use an electric razor when shaving and a soft||
1969|139|P|toothbrush when brushing your teeth. If you fall or injure||
1969|140|P|yourself, especially if you hit your head, call your doctor right||
1969|141|P|away. Your doctor may need to check you.||
1969|142|P|   Older adults may be more sensitive to the side effects of this||
1969|143|P|drug, especially bleeding.||
1969|144|P|   During pregnancy, this medication should be used only when||
1969|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
1969|146|P|   This medication passes into breast milk. Consult your doctor||
1969|147|P|before breastfeeding.||
1969|148|B|||
1969|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1969|150|I|medications work or increase your risk for serious side effects.||
1969|151|I|This document does not contain all possible drug interactions.||
1969|152|I|Keep a list of all the products you use (including||
1969|153|I|prescription/nonprescription drugs and herbal products) and share||
1969|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
1969|155|I|the dosage of any medicines without your doctor's approval.||
1969|156|I|   Some products that may interact with this drug are:||
1969|157|I|mifepristone, other drugs that can cause bleeding/bruising||
1969|158|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
1969|159|I|ibuprofen/naproxen, "blood thinners" such as||
1969|160|I|warfarin/enoxaparin), certain antidepressants (including SSRIs||
1969|161|I|such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine).||
1969|162|I|   Other medications can affect the removal of rivaroxaban from||
1969|163|I|your body, which may affect how rivaroxaban works. Examples||
1969|164|I|include cobicistat, dronedarone, ritonavir, certain azole||
1969|165|I|antifungals (itraconazole, ketoconazole, posaconazole), HIV||
1969|166|I|protease inhibitors (such as lopinavir), rifamycins (such as||
1969|167|I|rifampin), St. John's wort, drugs used to treat seizures (such as||
1969|168|I|carbamazepine, phenytoin, phenobarbital), among others.||
1969|169|I|   Check all prescription and nonprescription medicine labels||
1969|170|I|carefully since many medications contain pain relievers/fever||
1969|171|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen) that may||
1969|172|I|increase your risk for bleeding if taken together with this||
1969|173|I|medication. However, if your doctor has told you to take low-dose||
1969|174|I|aspirin to prevent heart attack or stroke (usually at dosages of||
1969|175|I|75-100 milligrams a day), you should keep taking the aspirin||
1969|176|I|unless your doctor tells you not to. Ask your doctor or||
1969|177|I|pharmacist for more details.||
1969|178|B|||
1969|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1969|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1969|181|O|poison control center right away. US residents can call||
1969|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1969|183|O|Symptoms of overdose may include: bloody/black/tarry stools,||
1969|184|O|pink/dark urine, unusual/prolonged bleeding.||
1969|185|B|||
1969|186|N|NOTES:  Do not share this medication with others.||
1969|187|N|   Lab and/or medical tests (such as hematocrit/hemoglobin, red||
1969|188|N|blood cell count) may be done while you are taking this||
1969|189|N|medication. Keep all medical and lab appointments. Consult your||
1969|190|N|doctor for more details.||
1969|191|B|||
1969|192|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1969|193|D|next dose at the regular time. Do not double the dose to catch||
1969|194|D|up.||
1969|195|B|||
1969|196|R|STORAGE:  Store at room temperature away from light and moisture.||
1969|197|R|Do not store in the bathroom. Keep all medications away from||
1969|198|R|children and pets.||
1969|199|R|   Use/discard the crushed tablet mixture within 4 hours. (See||
1969|200|R|also How to Use section.)||
1969|201|R|   Do not flush medications down the toilet or pour them into a||
1969|202|R|drain unless instructed to do so. Properly discard this product||
1969|203|R|when it is expired or no longer needed. Consult your pharmacist||
1969|204|R|or local waste disposal company.||
1969|205|B|||
1969|206|M|MEDICAL ALERT:  Your condition can cause complications in a||
1969|207|M|medical emergency. For information about enrolling in MedicAlert,||
1969|208|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1969|209|B|||
1969|210|A|Information last revised June 2025.||
1969|211|A|Copyright(c) 2025 First Databank, Inc.||
1969|212|B|||
1970|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1970|002|Z|does NOT have all possible information about this product. This||
1970|003|Z|information does not assure that this product is safe, effective,||
1970|004|Z|or appropriate for you. This information is not individual||
1970|005|Z|medical advice and does not substitute for the advice of your||
1970|006|Z|health care professional. Always ask your health care||
1970|007|Z|professional for complete information about this product and your||
1970|008|Z|specific health needs.||
1970|009|B|||
1970|010|T|AMIKACIN LIPOSOMAL - INHALATION||
1970|011|F|(AM-i-KAY-sin)||
1970|012|B|||
1970|013|C|COMMON BRAND NAME(S): Arikayce||
1970|014|B|||
1970|015|W|WARNING:  Amikacin liposomal may increase the risk of serious||
1970|016|W|breathing or lung problems. Tell your doctor right away if you||
1970|017|W|have symptoms such as new or worsening shortness of||
1970|018|W|breath/trouble breathing, fever, cough, wheezing, or coughing up||
1970|019|W|blood or blood-tinged sputum.||
1970|020|B|||
1970|021|U|USES:  This medication is used along with other medications to||
1970|022|U|treat a certain lung infection (Mycobacterium avium complex-MAC)||
1970|023|U|after other treatments have not worked. Amikacin belongs to a||
1970|024|U|class of drugs known as aminoglycoside antibiotics. This||
1970|025|U|medication works by stopping the growth of bacteria.||
1970|026|U|   This antibiotic treats only bacterial infections. It will not||
1970|027|U|work for viral infections (such as common cold, flu). Using any||
1970|028|U|antibiotic when it is not needed can cause it to not work for||
1970|029|U|future infections.||
1970|030|B|||
1970|031|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1970|032|H|provided by your pharmacist before you start using amikacin and||
1970|033|H|each time you get a refill. This medication is used with a||
1970|034|H|special machine called a nebulizer that changes the solution to a||
1970|035|H|fine mist that you inhale. Learn and follow all instructions for||
1970|036|H|the use of this medication and the nebulizer. If you have any||
1970|037|H|questions, ask your doctor, pharmacist, or respiratory therapist.||
1970|038|H|   Use this medication with the nebulizer as directed by your||
1970|039|H|doctor, usually once daily. If this medication has been stored in||
1970|040|H|the refrigerator, take the vial out of the refrigerator and let||
1970|041|H|it warm up to room temperature for at least 45 minutes before||
1970|042|H|use. Do not heat this medication any other way, such as by||
1970|043|H|heating in the microwave or placing in hot water. Shake the vial||
1970|044|H|well for at least 10 to 15 seconds, until the medicine looks the||
1970|045|H|same throughout and well mixed. Use all of the contents of the||
1970|046|H|vial for each dose. Do not mix amikacin liposomal with any other||
1970|047|H|medicines in the nebulizer. Each treatment usually lasts about 14||
1970|048|H|to 20 minutes.||
1970|049|H|   For the best effect, use this antibiotic at evenly spaced||
1970|050|H|times. To help you remember, use this medication at the same time||
1970|051|H|every day.||
1970|052|H|   Continue to use this medication until the full prescribed||
1970|053|H|amount is finished, even if symptoms disappear after a few days.||
1970|054|H|Stopping the medication too early may result in a return of the||
1970|055|H|infection.||
1970|056|H|   Tell your doctor if your condition does not get better or if||
1970|057|H|it gets worse.||
1970|058|B|||
1970|059|S|SIDE EFFECTS:  See also Warning section.||
1970|060|S|   Hoarseness, changes in your voice, nausea, diarrhea, headache,||
1970|061|S|tiredness, decreased weight, or muscle/joint pain may occur. If||
1970|062|S|any of these effects last or get worse, tell your doctor or||
1970|063|S|pharmacist promptly.||
1970|064|S|   Remember that this medication has been prescribed because your||
1970|065|S|doctor has judged that the benefit to you is greater than the||
1970|066|S|risk of side effects. Many people using this medication do not||
1970|067|S|have serious side effects.||
1970|068|S|   Tell your doctor right away if you have any serious side||
1970|069|S|effects, including: signs of hearing damage (such as||
1970|070|S|ringing/roaring sounds in the ears, hearing loss, dizziness),||
1970|071|S|signs of kidney problems (such as change in the amount of urine).||
1970|072|S|   A very serious allergic reaction to this drug is rare.||
1970|073|S|However, get medical help right away if you notice any symptoms||
1970|074|S|of a serious allergic reaction, including: rash, itching/swelling||
1970|075|S|(especially of the face/tongue/throat), severe dizziness,||
1970|076|S|wheezing/unusual trouble breathing.||
1970|077|S|   This is not a complete list of possible side effects. If you||
1970|078|S|notice other effects not listed above, contact your doctor or||
1970|079|S|pharmacist.||
1970|080|S|   In the US -||
1970|081|S|   Call your doctor for medical advice about side effects. You||
1970|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1970|083|S|www.fda.gov/medwatch.||
1970|084|S|   In Canada - Call your doctor for medical advice about side||
1970|085|S|effects. You may report side effects to Health Canada at||
1970|086|S|1-866-234-2345.||
1970|087|B|||
1970|088|P|PRECAUTIONS:  Before using amikacin liposomal, tell your doctor||
1970|089|P|or pharmacist if you are allergic to it; or to amikacin; or to||
1970|090|P|other aminoglycoside antibiotics (such as gentamicin); or if you||
1970|091|P|have any other allergies. This product may contain inactive||
1970|092|P|ingredients, which can cause allergic reactions or other||
1970|093|P|problems. Talk to your pharmacist for more details.||
1970|094|P|   Before using this medication, tell your doctor or pharmacist||
1970|095|P|your medical history, especially of: other breathing problems||
1970|096|P|(such as asthma, chronic obstructive pulmonary disease-COPD),||
1970|097|P|hearing problems (including deafness, decreased hearing), kidney||
1970|098|P|problems, myasthenia gravis, Parkinson's disease.||
1970|099|P|   Amikacin may cause live bacterial vaccines (such as typhoid||
1970|100|P|vaccine) to not work well. Tell your health care professional||
1970|101|P|that you are using amikacin before having any||
1970|102|P|immunizations/vaccinations.||
1970|103|P|   Before having surgery, tell your doctor or dentist about all||
1970|104|P|the products you use (including prescription drugs,||
1970|105|P|nonprescription drugs, and herbal products).||
1970|106|P|   During pregnancy, this medication should be used only when||
1970|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
1970|108|P|   It is unknown if inhaled amikacin liposomal passes into breast||
1970|109|P|milk. However, other forms of this drug pass into breast milk in||
1970|110|P|very small amounts. Consult your doctor before breastfeeding.||
1970|111|B|||
1970|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1970|113|I|medications work or increase your risk for serious side effects.||
1970|114|I|This document does not contain all possible drug interactions.||
1970|115|I|Keep a list of all the products you use (including||
1970|116|I|prescription/nonprescription drugs and herbal products) and share||
1970|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
1970|118|I|the dosage of any medicines without your doctor's approval.||
1970|119|B|||
1970|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1970|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1970|122|O|poison control center right away. US residents can call||
1970|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1970|124|B|||
1970|125|N|NOTES:  Do not share this medication with others.||
1970|126|N|   Lab and/or medical tests (such as breathing tests, hearing||
1970|127|N|tests, kidney function) may be done while you are using this||
1970|128|N|medication. Keep all medical and lab appointments.||
1970|129|B|||
1970|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1970|131|D|If you don't remember until the next day, skip the missed dose.||
1970|132|D|Use your next dose at the regular time. Do not double the dose to||
1970|133|D|catch up.||
1970|134|B|||
1970|135|R|STORAGE:  Store in the refrigerator away from light. Do not||
1970|136|R|freeze. This medication may also be stored at room temperature if||
1970|137|R|needed. If the medication is stored at room temperature, discard||
1970|138|R|after 4 weeks. Keep all medications away from children and pets.||
1970|139|R|   Do not flush medications down the toilet or pour them into a||
1970|140|R|drain unless instructed to do so. Properly discard this product||
1970|141|R|when it is expired or no longer needed. Consult your pharmacist||
1970|142|R|or local waste disposal company.||
1970|143|B|||
1970|144|A|Information last revised September 2024.||
1970|145|A|Copyright(c) 2025 First Databank, Inc.||
1970|146|B|||
1971|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1971|002|Z|does NOT have all possible information about this product. This||
1971|003|Z|information does not assure that this product is safe, effective,||
1971|004|Z|or appropriate for you. This information is not individual||
1971|005|Z|medical advice and does not substitute for the advice of your||
1971|006|Z|health care professional. Always ask your health care||
1971|007|Z|professional for complete information about this product and your||
1971|008|Z|specific health needs.||
1971|009|B|||
1971|010|T|TALAZOPARIB - ORAL||
1971|011|F|(TAL-a-ZOE-pa-rib)||
1971|012|B|||
1971|013|C|COMMON BRAND NAME(S): Talzenna||
1971|014|B|||
1971|015|U|USES:  This medication is used to treat certain cancers (such as||
1971|016|U|breast, prostate). Talazoparib works by slowing or stopping the||
1971|017|U|growth of cancer cells.||
1971|018|B|||
1971|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1971|020|H|from your pharmacist before you start taking talazoparib and each||
1971|021|H|time you get a refill. If you have any questions, ask your doctor||
1971|022|H|or pharmacist.||
1971|023|H|   Take this medication by mouth with or without food as directed||
1971|024|H|by your doctor, usually once daily. Swallow the capsules whole.||
1971|025|H|Do not open or dissolve the capsules. The dosage is based on your||
1971|026|H|medical condition, response to treatment, and other medications||
1971|027|H|you may be taking. Be sure to tell your doctor and pharmacist||
1971|028|H|about all the products you use (including prescription drugs,||
1971|029|H|nonprescription drugs, and herbal products).||
1971|030|H|   If you vomit after taking a dose, do not take another dose at||
1971|031|H|that time. Take your next dose at the regular time.||
1971|032|H|   Do not increase your dose or use this drug more often or for||
1971|033|H|longer than prescribed. Your condition will not improve any||
1971|034|H|faster, and your risk of side effects will increase.||
1971|035|H|   Since this drug can be absorbed through the skin and lungs and||
1971|036|H|may harm an unborn baby, women who are pregnant or who may become||
1971|037|H|pregnant should not handle this medication or breathe the dust||
1971|038|H|from the capsules.||
1971|039|B|||
1971|040|S|SIDE EFFECTS:  Nausea, vomiting, decreased appetite, diarrhea,||
1971|041|S|stomach/abdominal pain, headache, tiredness, change in how food||
1971|042|S|tastes, or dizziness may occur. If any of these effects last or||
1971|043|S|get worse, tell your doctor or pharmacist promptly.||
1971|044|S|   Temporary hair loss may occur. Normal hair growth should||
1971|045|S|return after treatment has ended.||
1971|046|S|   People using this medication may have serious side effects.||
1971|047|S|However, you have been prescribed this drug because your doctor||
1971|048|S|has judged that the benefit to you is greater than the risk of||
1971|049|S|side effects. Careful monitoring by your doctor may decrease your||
1971|050|S|risk.||
1971|051|S|   This medication decreases bone marrow function, an effect that||
1971|052|S|may lead to a low number of blood cells such as red cells, white||
1971|053|S|cells, and platelets. This effect can cause anemia, decrease your||
1971|054|S|body's ability to fight an infection, or cause easy||
1971|055|S|bruising/bleeding. Rarely, these problems can also be symptoms of||
1971|056|S|very serious (possibly fatal) cancer of the bone marrow or blood||
1971|057|S|cells (myelodysplastic syndrome, acute myeloid leukemia),||
1971|058|S|especially if you have had radiation or chemotherapy treatment.||
1971|059|S|Tell your doctor right away if you develop any of the following||
1971|060|S|symptoms: weakness, unusual weight loss, pale skin, signs of||
1971|061|S|infection (such as sore throat that doesn't go away, fever,||
1971|062|S|chills), easy bruising/bleeding.||
1971|063|S|   A very serious allergic reaction to this drug is rare.||
1971|064|S|However, get medical help right away if you notice any symptoms||
1971|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1971|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1971|067|S|breathing.||
1971|068|S|   This is not a complete list of possible side effects. If you||
1971|069|S|notice other effects not listed above, contact your doctor or||
1971|070|S|pharmacist.||
1971|071|S|   In the US -||
1971|072|S|   Call your doctor for medical advice about side effects. You||
1971|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1971|074|S|www.fda.gov/medwatch.||
1971|075|S|   In Canada - Call your doctor for medical advice about side||
1971|076|S|effects. You may report side effects to Health Canada at||
1971|077|S|1-866-234-2345.||
1971|078|B|||
1971|079|P|PRECAUTIONS:  Before taking talazoparib, tell your doctor or||
1971|080|P|pharmacist if you are allergic to it; or if you have any other||
1971|081|P|allergies. This product may contain inactive ingredients, which||
1971|082|P|can cause allergic reactions or other problems. Talk to your||
1971|083|P|pharmacist for more details.||
1971|084|P|   Before using this medication, tell your doctor or pharmacist||
1971|085|P|your medical history, especially of: kidney problems.||
1971|086|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1971|087|P|can make you more dizzy. Do not drive, use machinery, or do||
1971|088|P|anything that needs alertness until you can do it safely. Limit||
1971|089|P|alcoholic beverages. Talk to your doctor if you are using||
1971|090|P|marijuana (cannabis).||
1971|091|P|   Before having surgery, tell your doctor or dentist about all||
1971|092|P|the products you use (including prescription drugs,||
1971|093|P|nonprescription drugs, and herbal products).||
1971|094|P|   Talazoparib can make you more likely to get infections or may||
1971|095|P|make current infections worse. Stay away from anyone who has an||
1971|096|P|infection that may easily spread (such as chickenpox, COVID-19,||
1971|097|P|measles, flu). Talk to your doctor if you have been exposed to an||
1971|098|P|infection or for more details.||
1971|099|P|   Tell your health care professional that you are using||
1971|100|P|talazoparib before having any immunizations/vaccinations. Avoid||
1971|101|P|contact with people who have recently received live vaccines||
1971|102|P|(such as flu vaccine inhaled through the nose).||
1971|103|P|   To lower the chance of getting cut, bruised, or injured, use||
1971|104|P|caution with sharp objects like razors and nail cutters, and||
1971|105|P|avoid activities such as contact sports.||
1971|106|P|   Since this drug can be absorbed through the skin and lungs and||
1971|107|P|may harm an unborn baby, women who are pregnant or who may become||
1971|108|P|pregnant should not handle this medication or breathe the dust||
1971|109|P|from the capsules.||
1971|110|P|   Tell your doctor if you are pregnant or plan to become||
1971|111|P|pregnant. You should not become pregnant while using talazoparib.||
1971|112|P|Talazoparib may harm an unborn baby. Your doctor should order a||
1971|113|P|pregnancy test before you start this medication. Women using this||
1971|114|P|medication should ask about reliable forms of birth control||
1971|115|P|during treatment and for at least 7 months after the last dose.||
1971|116|P|Men using this medication who have a partner that is pregnant or||
1971|117|P|who can become pregnant should ask about reliable forms of birth||
1971|118|P|control during treatment and for at least 4 months after the last||
1971|119|P|dose. If you or your partner becomes pregnant, talk to your||
1971|120|P|doctor right away about the risks and benefits of this||
1971|121|P|medication.||
1971|122|P|   It is unknown if this drug passes into breast milk. Because of||
1971|123|P|the possible risk to the infant, breastfeeding is not recommended||
1971|124|P|while using this drug and for at least 1 month after the last||
1971|125|P|dose. Consult your doctor before breastfeeding.||
1971|126|B|||
1971|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1971|128|I|medications work or increase your risk for serious side effects.||
1971|129|I|This document does not contain all possible drug interactions.||
1971|130|I|Keep a list of all the products you use (including||
1971|131|I|prescription/nonprescription drugs and herbal products) and share||
1971|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
1971|133|I|the dosage of any medicines without your doctor's approval.||
1971|134|B|||
1971|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1971|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1971|137|O|poison control center right away. US residents can call||
1971|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1971|139|B|||
1971|140|N|NOTES:  Do not share this medication with others.||
1971|141|N|   Lab and/or medical tests (such as complete blood count, kidney||
1971|142|N|function) should be done before you start taking this medication||
1971|143|N|and while you are taking it. Keep all medical and lab||
1971|144|N|appointments. Consult your doctor for more details.||
1971|145|B|||
1971|146|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
1971|147|D|next dose at the regular time. Do not double the dose to catch||
1971|148|D|up.||
1971|149|B|||
1971|150|R|STORAGE:  Store at room temperature away from light and moisture.||
1971|151|R|Do not store in the bathroom. Keep all medications away from||
1971|152|R|children and pets.||
1971|153|R|   Do not flush medications down the toilet or pour them into a||
1971|154|R|drain unless instructed to do so. Properly discard this product||
1971|155|R|when it is expired or no longer needed. Consult your pharmacist||
1971|156|R|or local waste disposal company.||
1971|157|B|||
1971|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
1971|159|M|medical emergency. For information about enrolling in MedicAlert,||
1971|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1971|161|B|||
1971|162|A|Information last revised May 2024.||
1971|163|A|Copyright(c) 2025 First Databank, Inc.||
1971|164|B|||
1973|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1973|002|Z|does NOT have all possible information about this product. This||
1973|003|Z|information does not assure that this product is safe, effective,||
1973|004|Z|or appropriate for you. This information is not individual||
1973|005|Z|medical advice and does not substitute for the advice of your||
1973|006|Z|health care professional. Always ask your health care||
1973|007|Z|professional for complete information about this product and your||
1973|008|Z|specific health needs.||
1973|009|B|||
1973|010|T|BALOXAVIR MARBOXIL - ORAL||
1973|011|F|(bal-OX-a-vir mar-BOX-il)||
1973|012|B|||
1973|013|C|COMMON BRAND NAME(S): Xofluza||
1973|014|B|||
1973|015|U|USES:  Baloxavir marboxil is an antiviral medication used to||
1973|016|U|treat the flu (influenza) if your symptoms started less than 48||
1973|017|U|hours ago. It helps make the symptoms (such as stuffy nose,||
1973|018|U|cough, sore throat, fever/chills, aches, tiredness) less severe||
1973|019|U|and may shorten the recovery time by 1 to 2 days. Baloxavir||
1973|020|U|marboxil works by stopping the flu virus from growing. It will||
1973|021|U|not treat other kinds of infection besides the flu virus.||
1973|022|U|   This medication may also be used to prevent the flu if you||
1973|023|U|have been exposed to someone who already has the flu (such as a||
1973|024|U|sick household member) or if there is a flu outbreak in the||
1973|025|U|community. Talk to your doctor for more details.||
1973|026|U|   This medication should not be used in children younger than 5||
1973|027|U|since it may not be effective.||
1973|028|U|   Baloxavir marboxil is not a substitute for the flu vaccine.||
1973|029|U|(See also Notes section.)||
1973|030|B|||
1973|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1973|032|H|from your pharmacist before you take baloxavir marboxil. If you||
1973|033|H|have any questions, ask your doctor or pharmacist.||
1973|034|H|   Take this medication by mouth with or without food as directed||
1973|035|H|by your doctor, usually a single dose. The dosage is based on||
1973|036|H|your weight.||
1973|037|H|   For the best effect, take this medication at least 4 hours||
1973|038|H|before or 2 hours after taking other products that contain||
1973|039|H|aluminum, iron, zinc, selenium, calcium, or magnesium. These||
1973|040|H|products may make this medication not work well. Some examples||
1973|041|H|include antacids, vitamins/minerals, dairy products (such as||
1973|042|H|milk, yogurt), and juice with added calcium.||
1973|043|H|   Other kinds of infections may have symptoms like flu or can||
1973|044|H|occur along with flu. These infections may need different kinds||
1973|045|H|of treatment. Tell your doctor if you develop new symptoms during||
1973|046|H|or after treatment, or if your condition does not get better, or||
1973|047|H|if it gets worse.||
1973|048|B|||
1973|049|S|SIDE EFFECTS:  Baloxavir marboxil usually has very few side||
1973|050|S|effects. If you have any unusual effects, tell your doctor or||
1973|051|S|pharmacist promptly.||
1973|052|S|   Remember that this medication has been prescribed because your||
1973|053|S|doctor has judged that the benefit to you is greater than the||
1973|054|S|risk of side effects. Many people using this medication do not||
1973|055|S|have serious side effects.||
1973|056|S|   A very serious allergic reaction to this drug is rare.||
1973|057|S|However, get medical help right away if you notice any symptoms||
1973|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1973|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1973|060|S|breathing.||
1973|061|S|   This is not a complete list of possible side effects. If you||
1973|062|S|notice other effects not listed above, contact your doctor or||
1973|063|S|pharmacist.||
1973|064|S|   In the US -||
1973|065|S|   Call your doctor for medical advice about side effects. You||
1973|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1973|067|S|www.fda.gov/medwatch.||
1973|068|S|   In Canada - Call your doctor for medical advice about side||
1973|069|S|effects. You may report side effects to Health Canada at||
1973|070|S|1-866-234-2345.||
1973|071|B|||
1973|072|P|PRECAUTIONS:  Before taking baloxavir marboxil, tell your doctor||
1973|073|P|or pharmacist if you are allergic to it; or if you have any other||
1973|074|P|allergies. This product may contain inactive ingredients, which||
1973|075|P|can cause allergic reactions or other problems. Talk to your||
1973|076|P|pharmacist for more details.||
1973|077|P|   Before using this medication, tell your doctor or pharmacist||
1973|078|P|your medical history.||
1973|079|P|   Before having surgery, tell your doctor or dentist about all||
1973|080|P|the products you use (including prescription drugs,||
1973|081|P|nonprescription drugs, and herbal products).||
1973|082|P|   During pregnancy, this medication should be used only when||
1973|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
1973|084|P|   It is unknown if this medication passes into breast milk.||
1973|085|P|Consult your doctor before breastfeeding.||
1973|086|B|||
1973|087|I|DRUG INTERACTIONS:  See also How to Use section.||
1973|088|I|   Drug interactions may change how your medications work or||
1973|089|I|increase your risk for serious side effects. This document does||
1973|090|I|not contain all possible drug interactions. Keep a list of all||
1973|091|I|the products you use (including prescription/nonprescription||
1973|092|I|drugs and herbal products) and share it with your doctor and||
1973|093|I|pharmacist. Do not start, stop, or change the dosage of any||
1973|094|I|medicines without your doctor's approval.||
1973|095|I|   Tell your doctor if you have received flu vaccine in the nose||
1973|096|I|within 2 weeks before treatment with this medication. This||
1973|097|I|medication may lower your protection from flu vaccine given in||
1973|098|I|the nose. After treatment with this medication, talk with your||
1973|099|I|doctor or pharmacist before receiving flu vaccine.||
1973|100|B|||
1973|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1973|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1973|103|O|poison control center right away. US residents can call||
1973|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1973|105|B|||
1973|106|N|NOTES:  Do not share this medication with others.||
1973|107|N|   This medication is not a substitute for the flu vaccine.||
1973|108|N|Consult your doctor about the risks and important benefits of||
1973|109|N|receiving a yearly flu shot to lower your chances of getting the||
1973|110|N|flu.||
1973|111|B|||
1973|112|D|MISSED DOSE:  Not applicable.||
1973|113|B|||
1973|114|R|STORAGE:  Store at room temperature away from light and moisture.||
1973|115|R|Do not store in the bathroom. Keep all medications away from||
1973|116|R|children and pets.||
1973|117|R|   Do not flush medications down the toilet or pour them into a||
1973|118|R|drain unless instructed to do so. Properly discard this product||
1973|119|R|when it is expired or no longer needed. Consult your pharmacist||
1973|120|R|or local waste disposal company.||
1973|121|B|||
1973|122|A|Information last revised September 2025.||
1973|123|A|Copyright(c) 2025 First Databank, Inc.||
1973|124|B|||
1974|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1974|002|Z|does NOT have all possible information about this product. This||
1974|003|Z|information does not assure that this product is safe, effective,||
1974|004|Z|or appropriate for you. This information is not individual||
1974|005|Z|medical advice and does not substitute for the advice of your||
1974|006|Z|health care professional. Always ask your health care||
1974|007|Z|professional for complete information about this product and your||
1974|008|Z|specific health needs.||
1974|009|B|||
1974|010|T|INOTERSEN - SUBCUTANEOUS INJECTION||
1974|011|F|(IN-oh-TER-sen)||
1974|012|B|||
1974|013|C|COMMON BRAND NAME(S): Tegsedi||
1974|014|B|||
1974|015|W|WARNING:  This medication decreases the number of platelets in||
1974|016|W|your blood, which may cause serious (even fatal) bleeding||
1974|017|W|problems. Tell your doctor right away if you notice symptoms such||
1974|018|W|as easy bruising, a rash of tiny reddish-purple spots (especially||
1974|019|W|on your lower legs), bleeding gums, nosebleeds, blood in||
1974|020|W|urine/stools, vomiting or coughing up blood, neck stiffness,||
1974|021|W|unusual severe headache, or unusual/heavy menstrual periods||
1974|022|W|(women).||
1974|023|W|   This medication can cause serious kidney damage that may||
1974|024|W|result in the need for dialysis. Tell your doctor right away if||
1974|025|W|you have swelling in your face/feet/hands, shortness of breath,||
1974|026|W|cough, blood in urine, brown/foamy urine, or change in amount of||
1974|027|W|urine.||
1974|028|W|   Careful monitoring and treatment by your doctor may decrease||
1974|029|W|your risk for serious side effects. Lab and/or medical tests||
1974|030|W|(such as kidney/liver function, complete blood count, urine||
1974|031|W|tests) should be done before you start using this medication,||
1974|032|W|while you are using it, and for 8 weeks after stopping treatment.||
1974|033|W|Keep all medical and lab appointments.||
1974|034|W|   To receive inotersen in the United States, you must||
1974|035|W|understand, agree to, and carefully follow the requirements of||
1974|036|W|the REMS Program for this medication. If you live in Canada or||
1974|037|W|any other country, consult your doctor and pharmacist for your||
1974|038|W|country's regulations.||
1974|039|B|||
1974|040|U|USES:  This medication is used to treat nerve problems due to a||
1974|041|U|certain inherited condition (transthyretin-mediated amyloidosis).||
1974|042|U|This condition causes a protein that your body normally makes||
1974|043|U|(transthyretin-TTR), to change shape and build up in different||
1974|044|U|parts of your body, which can affect the nerves, heart, eyes, and||
1974|045|U|stomach/intestines. This medication works by decreasing the||
1974|046|U|buildup of TTR in your body.||
1974|047|B|||
1974|048|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1974|049|H|provided by your pharmacist before you start using inotersen and||
1974|050|H|each time you get a refill. Ask your health care professional how||
1974|051|H|to prepare and use this medication. If you have any questions,||
1974|052|H|ask your doctor or pharmacist.||
1974|053|H|   Inject this medication under the skin as directed by your||
1974|054|H|doctor, usually once weekly. The injection is given in the thigh,||
1974|055|H|abdomen, or upper arm. The dosage is based on your medical||
1974|056|H|condition and response to treatment.||
1974|057|H|   Take the medication out of the refrigerator at least 30||
1974|058|H|minutes before you inject it to allow it to reach room||
1974|059|H|temperature. Do not warm up this medication any other way (for||
1974|060|H|example, do not heat it in the microwave or place it in hot||
1974|061|H|water). Do not shake the medication. Before using, check this||
1974|062|H|product for particles or discoloration. If either is present, do||
1974|063|H|not use the liquid. Before injecting each dose, clean the skin||
1974|064|H|you are going to inject into (the injection site) with rubbing||
1974|065|H|alcohol. Change the injection site each time to lessen injury||
1974|066|H|under the skin. Do not inject into skin that is bruised, tender,||
1974|067|H|red, hard, or tattooed, or into scars. To lessen bruising, do not||
1974|068|H|rub the injection site after a shot. Learn how to store and||
1974|069|H|discard medical supplies safely.||
1974|070|H|   Use this medication regularly to get the most benefit from it.||
1974|071|H|To help you remember, inject this medication on the same day each||
1974|072|H|week.||
1974|073|B|||
1974|074|S|SIDE EFFECTS:  See also Warning section.||
1974|075|S|   Bruising, redness, itching, pain, or swelling at the injection||
1974|076|S|site may occur. Nausea, vomiting, headache, fever, decreased||
1974|077|S|appetite, numbness/tingling, or tiredness may also occur. If any||
1974|078|S|of these effects last or get worse, tell your doctor or||
1974|079|S|pharmacist promptly.||
1974|080|S|   Remember that this medication has been prescribed because your||
1974|081|S|doctor has judged that the benefit to you is greater than the||
1974|082|S|risk of side effects. Many people using this medication do not||
1974|083|S|have serious side effects.||
1974|084|S|   Tell your doctor right away if you have any serious side||
1974|085|S|effects, including: back pain, unexpected change in walking,||
1974|086|S|symptoms of liver problems (such as nausea/vomiting that doesn't||
1974|087|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
1974|088|S|eyes/skin, dark urine).||
1974|089|S|   Get medical help right away if you have any very serious side||
1974|090|S|effects, including: symptoms of stroke (such as weakness on one||
1974|091|S|side of the body, trouble speaking, sudden vision changes,||
1974|092|S|confusion).||
1974|093|S|   This medication decreases vitamin A levels in your blood. Ask||
1974|094|S|your doctor about taking a vitamin A supplement. Tell your doctor||
1974|095|S|right away if you develop signs of a lack of vitamin A,||
1974|096|S|especially vision changes such as dry eyes, blurred vision, or||
1974|097|S|trouble seeing in dim light (night blindness).||
1974|098|S|   A very serious allergic reaction to this drug is rare.||
1974|099|S|However, get medical help right away if you notice any symptoms||
1974|100|S|of a serious allergic reaction, including: rash, itching/swelling||
1974|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1974|102|S|breathing, muscle/joint pain, flushing/chills, chest pain,||
1974|103|S|trouble swallowing, redness on palms of your hands.||
1974|104|S|   This is not a complete list of possible side effects. If you||
1974|105|S|notice other effects not listed above, contact your doctor or||
1974|106|S|pharmacist.||
1974|107|S|   In the US -||
1974|108|S|   Call your doctor for medical advice about side effects. You||
1974|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1974|110|S|www.fda.gov/medwatch.||
1974|111|S|   In Canada - Call your doctor for medical advice about side||
1974|112|S|effects. You may report side effects to Health Canada at||
1974|113|S|1-866-234-2345.||
1974|114|B|||
1974|115|P|PRECAUTIONS:  Before using inotersen, tell your doctor or||
1974|116|P|pharmacist if you are allergic to it; or if you have any other||
1974|117|P|allergies. This product may contain inactive ingredients which||
1974|118|P|can cause allergic reactions or other problems. Talk to your||
1974|119|P|pharmacist for more details.||
1974|120|P|   Before using this medication, tell your doctor or pharmacist||
1974|121|P|your medical history, especially of: bleeding/blood problems,||
1974|122|P|kidney problems, liver transplant.||
1974|123|P|   Before having surgery, tell your doctor or dentist about all||
1974|124|P|the products you use (including prescription drugs,||
1974|125|P|nonprescription drugs, and herbal products).||
1974|126|P|   During pregnancy, this medication should be used only when||
1974|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
1974|128|P|   It is unknown if this medication passes into breast milk.||
1974|129|P|Consult your doctor before breastfeeding.||
1974|130|B|||
1974|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1974|132|I|medications work or increase your risk for serious side effects.||
1974|133|I|This document does not contain all possible drug interactions.||
1974|134|I|Keep a list of all the products you use (including||
1974|135|I|prescription/nonprescription drugs and herbal products) and share||
1974|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
1974|137|I|the dosage of any medicines without your doctor's approval.||
1974|138|I|   This medication may interfere with certain lab tests (such as||
1974|139|I|platelet counts), possibly causing false test results. Make sure||
1974|140|I|lab personnel and all your doctors know you use this drug.||
1974|141|B|||
1974|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1974|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1974|144|O|poison control center right away. US residents can call||
1974|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1974|146|B|||
1974|147|N|NOTES:  Do not share this medication with others.||
1974|148|N|   Lab and/or medical tests (such as kidney function, complete||
1974|149|N|blood count, liver function, urine tests) must be done before you||
1974|150|N|start using this medication and while you are using it. Keep all||
1974|151|N|medical and lab appointments.||
1974|152|B|||
1974|153|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1974|154|D|If it is within 2 days of the next dose, skip the missed dose.||
1974|155|D|Use your next dose on your regular day. Do not double the dose to||
1974|156|D|catch up.||
1974|157|B|||
1974|158|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
1974|159|R|medication in original carton to protect from light. This||
1974|160|R|medication may also be stored at room temperature if needed. If||
1974|161|R|the medication is stored at room temperature, discard after 6||
1974|162|R|weeks. Keep all medications away from children and pets.||
1974|163|R|   Do not flush medications down the toilet or pour them into a||
1974|164|R|drain unless instructed to do so. Properly discard this product||
1974|165|R|when it is expired or no longer needed. Consult your pharmacist||
1974|166|R|or local waste disposal company.||
1974|167|B|||
1974|168|A|Information last revised October 2024.||
1974|169|A|Copyright(c) 2025 First Databank, Inc.||
1974|170|B|||
1975|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1975|002|Z|does NOT have all possible information about this product. This||
1975|003|Z|information does not assure that this product is safe, effective,||
1975|004|Z|or appropriate for you. This information is not individual||
1975|005|Z|medical advice and does not substitute for the advice of your||
1975|006|Z|health care professional. Always ask your health care||
1975|007|Z|professional for complete information about this product and your||
1975|008|Z|specific health needs.||
1975|009|B|||
1975|010|T|HALOBETASOL FOAM - TOPICAL||
1975|011|F|(HAL-oh-BAY-ta-sol)||
1975|012|B|||
1975|013|C|COMMON BRAND NAME(S): Lexette||
1975|014|B|||
1975|015|U|USES:  This medication is used to treat certain skin conditions||
1975|016|U|(such as psoriasis). Halobetasol helps reduce the itching,||
1975|017|U|redness, scaling, and swelling that can occur with these||
1975|018|U|conditions. This medication is a very strong (super-high potency)||
1975|019|U|corticosteroid.||
1975|020|B|||
1975|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
1975|022|H|Instructions for Use if available from your pharmacist before you||
1975|023|H|start using halobetasol foam and each time you get a refill. If||
1975|024|H|you have any questions, ask your doctor or pharmacist.||
1975|025|H|   Use this medication only on the skin. However, do not use it||
1975|026|H|on the face, groin, or underarms unless directed to do so by your||
1975|027|H|doctor.||
1975|028|H|   Shake the can well before using. Wash and dry your hands||
1975|029|H|before applying the medication. Hold the can upside down to spray||
1975|030|H|a small amount into the palm of your hand. Apply a thin layer||
1975|031|H|onto the affected area(s) as directed by your doctor, usually 2||
1975|032|H|times daily. After applying the foam, gently rub in until the||
1975|033|H|medication disappears. Do not cover, bandage, or wrap the area||
1975|034|H|unless directed to do so by your doctor.||
1975|035|H|   After applying the medication, wash your hands, unless you are||
1975|036|H|using this medication to treat the hands. Avoid getting this||
1975|037|H|medication in the eyes, nose, or mouth. If you get the medication||
1975|038|H|in these areas, rinse with plenty of water.||
1975|039|H|   Use this medication only for the condition it was prescribed||
1975|040|H|for. Do not apply more than directed, or use it more often or for||
1975|041|H|longer than prescribed by your doctor.||
1975|042|H|   Tell your doctor if your condition does not get better or if||
1975|043|H|it gets worse after 2 weeks.||
1975|044|B|||
1975|045|S|SIDE EFFECTS:  Burning, stinging, irritation, dryness, or redness||
1975|046|S|at the application site may occur. Acne, new/unwanted hair||
1975|047|S|growth, small red bumps on the skin (folliculitis), skin||
1975|048|S|thinning/discoloration, or stretch marks may also occur. If any||
1975|049|S|of these effects last or get worse, tell your doctor or||
1975|050|S|pharmacist promptly.||
1975|051|S|   Remember that this medication has been prescribed because your||
1975|052|S|doctor has judged that the benefit to you is greater than the||
1975|053|S|risk of side effects. Many people using this medication do not||
1975|054|S|have serious side effects.||
1975|055|S|   Skin infections can become worse when using this medication.||
1975|056|S|Tell your doctor promptly if redness, swelling, or irritation||
1975|057|S|does not improve.||
1975|058|S|   Rarely, it is possible this medication will be absorbed from||
1975|059|S|the skin into the bloodstream. This can lead to side effects of||
1975|060|S|too much corticosteroid. These side effects are more likely in||
1975|061|S|children, and in people who use this medication for a long time||
1975|062|S|or over large areas of the skin. Tell your doctor right away if||
1975|063|S|any of the following side effects occur: unusual/extreme||
1975|064|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
1975|065|S|thirst/urination, vision problems.||
1975|066|S|   A very serious allergic reaction to this drug is rare.||
1975|067|S|However, get medical help right away if you notice any symptoms||
1975|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1975|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1975|070|S|breathing.||
1975|071|S|   This is not a complete list of possible side effects. If you||
1975|072|S|notice other effects not listed above, contact your doctor or||
1975|073|S|pharmacist.||
1975|074|S|   In the US -||
1975|075|S|   Call your doctor for medical advice about side effects. You||
1975|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1975|077|S|www.fda.gov/medwatch.||
1975|078|S|   In Canada - Call your doctor for medical advice about side||
1975|079|S|effects. You may report side effects to Health Canada at||
1975|080|S|1-866-234-2345.||
1975|081|B|||
1975|082|P|PRECAUTIONS:  Before using halobetasol, tell your doctor or||
1975|083|P|pharmacist if you are allergic to it; or to other corticosteroids||
1975|084|P|(such as hydrocortisone, prednisone); or if you have any other||
1975|085|P|allergies. This product may contain inactive ingredients, which||
1975|086|P|can cause allergic reactions or other problems. Talk to your||
1975|087|P|pharmacist for more details.||
1975|088|P|   Before using this medication, tell your doctor or pharmacist||
1975|089|P|your medical history.||
1975|090|P|   Do not use if there is an infection or sore in the area to be||
1975|091|P|treated.||
1975|092|P|   Rarely, using corticosteroid medications for a long time or||
1975|093|P|over large areas of skin can make it more difficult for your body||
1975|094|P|to respond to physical stress. Before having surgery or emergency||
1975|095|P|treatment, or if you get a serious illness/injury, tell your||
1975|096|P|doctor or dentist that you are using this medication or have used||
1975|097|P|this medication within the past few months.||
1975|098|P|   Though it is unlikely, this medication may temporarily slow||
1975|099|P|down a child's growth if used for a long time. See the doctor||
1975|100|P|regularly so your child's height can be checked.||
1975|101|P|   During pregnancy, this medication should be used only when||
1975|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
1975|103|P|   It is unknown if this drug passes into breast milk when||
1975|104|P|applied to the skin. Similar medications pass into breast milk||
1975|105|P|when taken by mouth. Consult your doctor before breastfeeding.||
1975|106|B|||
1975|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1975|108|I|medications work or increase your risk for serious side effects.||
1975|109|I|This document does not contain all possible drug interactions.||
1975|110|I|Keep a list of all the products you use (including||
1975|111|I|prescription/nonprescription drugs and herbal products) and share||
1975|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
1975|113|I|the dosage of any medicines without your doctor's approval.||
1975|114|B|||
1975|115|O|OVERDOSE:  This medication may be harmful if swallowed. If||
1975|116|O|someone has overdosed and has serious symptoms such as passing||
1975|117|O|out or trouble breathing, call 911. Otherwise, call a poison||
1975|118|O|control center right away. US residents can call 1-800-222-1222.||
1975|119|O|Canada residents can call 1-844-764-7669.||
1975|120|B|||
1975|121|N|NOTES:  Do not share this medication with others.||
1975|122|N|   This medication has been prescribed for your current condition||
1975|123|N|only. Do not use it later for other skin problems unless your||
1975|124|N|doctor tells you to. A different medication may be necessary in||
1975|125|N|those cases.||
1975|126|N|   Lab and/or medical tests (such as adrenal gland function) may||
1975|127|N|be done while you are using this medication, especially if you||
1975|128|N|use this drug for a long time or apply it over large areas of the||
1975|129|N|body. Keep all medical and lab appointments.||
1975|130|B|||
1975|131|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1975|132|D|If it is near the time of the next dose, skip the missed dose.||
1975|133|D|Use your next dose at the regular time. Do not double the dose to||
1975|134|D|catch up.||
1975|135|B|||
1975|136|R|STORAGE:  Store at room temperature. Do not freeze. Do not||
1975|137|R|puncture the can or expose to high heat or open flame. Keep all||
1975|138|R|medications away from children and pets.||
1975|139|R|   Do not flush medications down the toilet or pour them into a||
1975|140|R|drain unless instructed to do so. Properly discard this product||
1975|141|R|when it is expired or no longer needed. Consult your pharmacist||
1975|142|R|or local waste disposal company.||
1975|143|B|||
1975|144|A|Information last revised May 2024.||
1975|145|A|Copyright(c) 2025 First Databank, Inc.||
1975|146|B|||
1976|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1976|002|Z|does NOT have all possible information about this product. This||
1976|003|Z|information does not assure that this product is safe, effective,||
1976|004|Z|or appropriate for you. This information is not individual||
1976|005|Z|medical advice and does not substitute for the advice of your||
1976|006|Z|health care professional. Always ask your health care||
1976|007|Z|professional for complete information about this product and your||
1976|008|Z|specific health needs.||
1976|009|B|||
1976|010|T|LORLATINIB - ORAL||
1976|011|F|(lor-LA-ti-nib)||
1976|012|B|||
1976|013|C|COMMON BRAND NAME(S): Lorbrena||
1976|014|B|||
1976|015|U|USES:  Lorlatinib is used to treat a certain type of lung cancer.||
1976|016|U|It works by slowing or stopping the growth of cancer cells.||
1976|017|B|||
1976|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1976|019|H|from your pharmacist before you start taking lorlatinib and each||
1976|020|H|time you get a refill. If you have any questions, ask your doctor||
1976|021|H|or pharmacist.||
1976|022|H|   Take this medication by mouth with or without food as directed||
1976|023|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
1976|024|H|not crush, chew, or split the tablets. Do not take tablets that||
1976|025|H|are broken or cracked.||
1976|026|H|   The dosage is based on your medical condition, response to||
1976|027|H|treatment, and other medications you may be taking. Be sure to||
1976|028|H|tell your doctor and pharmacist about all the products you use||
1976|029|H|(including prescription drugs, nonprescription drugs, and herbal||
1976|030|H|products).||
1976|031|H|   Do not increase your dose or take this drug more often or for||
1976|032|H|longer than prescribed. Your condition will not improve any||
1976|033|H|faster, and your risk of serious side effects will increase.||
1976|034|H|   Use this medication regularly to get the most benefit from it.||
1976|035|H|To help you remember, take it at the same time each day.||
1976|036|H|   If you vomit after taking a dose, do not take an extra dose.||
1976|037|H|Take your next dose at the regular time.||
1976|038|B|||
1976|039|S|SIDE EFFECTS:  Tiredness, constipation, nausea/vomiting,||
1976|040|S|diarrhea, numbness/tingling of arms/legs, swelling||
1976|041|S|ankles/feet/hands, dizziness, headache, trouble sleeping, weight||
1976|042|S|gain, muscle/joint pain, or vision changes (such as blurred||
1976|043|S|vision, decreased vision) may occur. If any of these effects last||
1976|044|S|or get worse, tell your doctor or pharmacist promptly.||
1976|045|S|   Remember that this medication has been prescribed because your||
1976|046|S|doctor has judged that the benefit to you is greater than the||
1976|047|S|risk of side effects. Many people using this medication do not||
1976|048|S|have serious side effects.||
1976|049|S|   This medication may raise your blood pressure. Check your||
1976|050|S|blood pressure regularly and tell your doctor if the results are||
1976|051|S|high.||
1976|052|S|   Tell your doctor right away if you have any serious side||
1976|053|S|effects, including: signs of liver problems (such as||
1976|054|S|nausea/vomiting that doesn't stop, loss of appetite,||
1976|055|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1976|056|S|mental/mood changes (such as depression, agitation,||
1976|057|S|hallucinations, thoughts of suicide), slow heartbeat, fainting,||
1976|058|S|trouble speaking.||
1976|059|S|   This medication may make your blood sugar rise, which can||
1976|060|S|cause or worsen diabetes. Tell your doctor right away if you have||
1976|061|S|symptoms of high blood sugar, such as increased thirst/urination.||
1976|062|S|If you already have diabetes, check your blood sugar regularly as||
1976|063|S|directed and share the results with your doctor. Your doctor may||
1976|064|S|need to adjust your diabetes medication, exercise program, or||
1976|065|S|diet.||
1976|066|S|   Get medical help right away if you have any very serious side||
1976|067|S|effects, including: seizures, new/worsening lung disease (such as||
1976|068|S|shortness of breath, cough, fever, chest pain).||
1976|069|S|   A very serious allergic reaction to this drug is rare.||
1976|070|S|However, get medical help right away if you notice any symptoms||
1976|071|S|of a serious allergic reaction, including: rash, itching/swelling||
1976|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1976|073|S|breathing.||
1976|074|S|   This is not a complete list of possible side effects. If you||
1976|075|S|notice other effects not listed above, contact your doctor or||
1976|076|S|pharmacist.||
1976|077|S|   In the US -||
1976|078|S|   Call your doctor for medical advice about side effects. You||
1976|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1976|080|S|www.fda.gov/medwatch.||
1976|081|S|   In Canada - Call your doctor for medical advice about side||
1976|082|S|effects. You may report side effects to Health Canada at||
1976|083|S|1-866-234-2345.||
1976|084|B|||
1976|085|P|PRECAUTIONS:  Before taking lorlatinib, tell your doctor or||
1976|086|P|pharmacist if you are allergic to it or if you have any other||
1976|087|P|allergies. This product may contain inactive ingredients, which||
1976|088|P|can cause allergic reactions or other problems. Talk to your||
1976|089|P|pharmacist for more details.||
1976|090|P|   Before using this medication, tell your doctor or pharmacist||
1976|091|P|your medical history, especially of: liver disease, kidney||
1976|092|P|disease, mental/mood problems (such as depression), seizures,||
1976|093|P|diabetes, high blood pressure, high cholesterol/triglycerides,||
1976|094|P|slow heartbeat.||
1976|095|P|   This drug may make you dizzy or cause vision changes. Alcohol||
1976|096|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
1976|097|P|use machinery, or do anything that needs alertness or clear||
1976|098|P|vision until you can do it safely. Limit alcoholic beverages.||
1976|099|P|Talk to your doctor if you are using marijuana (cannabis).||
1976|100|P|   Before having surgery, tell your doctor or dentist about all||
1976|101|P|the products you use (including prescription drugs,||
1976|102|P|nonprescription drugs, and herbal products).||
1976|103|P|   Tell your doctor if you are pregnant or plan to become||
1976|104|P|pregnant. You should not become pregnant while using lorlatinib.||
1976|105|P|Lorlatinib may harm an unborn baby. Your doctor should order a||
1976|106|P|pregnancy test before you start this medication. Women using this||
1976|107|P|medication should ask about reliable non-hormonal forms of birth||
1976|108|P|control during treatment and for 6 months after the last dose.||
1976|109|P|Men using this medication should ask about reliable forms of||
1976|110|P|birth control during treatment and for 3 months after the last||
1976|111|P|dose. If you or your partner become pregnant, talk to your doctor||
1976|112|P|right away about the risks and benefits of this medication.||
1976|113|P|   It is unknown if this medication passes into breast milk.||
1976|114|P|Because of the possible risk to the infant, breastfeeding is not||
1976|115|P|recommended while using this medication and for 1 week after the||
1976|116|P|last dose. Consult your doctor before breastfeeding.||
1976|117|B|||
1976|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1976|119|I|medications work or increase your risk for serious side effects.||
1976|120|I|This document does not contain all possible drug interactions.||
1976|121|I|Keep a list of all the products you use (including||
1976|122|I|prescription/nonprescription drugs and herbal products) and share||
1976|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
1976|124|I|the dosage of any medicines without your doctor's approval.||
1976|125|I|   Other medications can affect the removal of lorlatinib from||
1976|126|I|your body, which may affect how lorlatinib works. Examples||
1976|127|I|include apalutamide, butalbital, enzalutamide, rifamycins (such||
1976|128|I|as rifampin), secobarbital, St. John's wort, drugs used to treat||
1976|129|I|seizures (such as carbamazepine, phenytoin), among others.||
1976|130|I|   This medication can speed up the removal of other medications||
1976|131|I|from your body, which may affect how they work. Examples of||
1976|132|I|affected drugs include dabigatran, daridorexant, elacestrant,||
1976|133|I|mavacamten, quizartinib, revumenib, among others.||
1976|134|I|   This medication may decrease the effectiveness of hormonal||
1976|135|I|birth control such as pills, patch, or ring. This could cause||
1976|136|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1976|137|I|use reliable backup birth control methods while using this||
1976|138|I|medication. Also tell your doctor if you have any new spotting or||
1976|139|I|breakthrough bleeding, because these may be signs that your birth||
1976|140|I|control is not working well.||
1976|141|B|||
1976|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1976|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1976|144|O|poison control center right away. US residents can call||
1976|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1976|146|B|||
1976|147|N|NOTES:  Do not share this medication with others.||
1976|148|N|   Lab and/or medical tests (such as liver function,||
1976|149|N|cholesterol/triglyceride levels, heart rate, complete blood||
1976|150|N|count, blood sugar, blood pressure) should be done before you||
1976|151|N|start taking this medication and while you are taking it. Keep||
1976|152|N|all medical and lab appointments.||
1976|153|B|||
1976|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1976|155|D|remember. If it is within 4 hours of the next dose, skip the||
1976|156|D|missed dose. Take your next dose at the regular time. Do not||
1976|157|D|double the dose to catch up.||
1976|158|B|||
1976|159|R|STORAGE:  Store at room temperature away from light and moisture.||
1976|160|R|Do not store in the bathroom. Keep all medications away from||
1976|161|R|children and pets.||
1976|162|R|   Do not flush medications down the toilet or pour them into a||
1976|163|R|drain unless instructed to do so. Properly discard this product||
1976|164|R|when it is expired or no longer needed. Consult your pharmacist||
1976|165|R|or local waste disposal company.||
1976|166|B|||
1976|167|A|Information last revised July 2025.||
1976|168|A|Copyright(c) 2025 First Databank, Inc.||
1976|169|B|||
1977|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1977|002|Z|does NOT have all possible information about this product. This||
1977|003|Z|information does not assure that this product is safe, effective,||
1977|004|Z|or appropriate for you. This information is not individual||
1977|005|Z|medical advice and does not substitute for the advice of your||
1977|006|Z|health care professional. Always ask your health care||
1977|007|Z|professional for complete information about this product and your||
1977|008|Z|specific health needs.||
1977|009|B|||
1977|010|T|TESTOSTERONE - SUBCUTANEOUS INJECTION||
1977|011|F|(tes-TOS-ter-one)||
1977|012|B|||
1977|013|C|COMMON BRAND NAME(S): Xyosted||
1977|014|B|||
1977|015|W|WARNING:  This medication can raise your blood pressure, which||
1977|016|W|can increase your risk of having a heart attack or stroke. Your||
1977|017|W|risk may be higher if you have a medical history of high blood||
1977|018|W|pressure, heart disease, or stroke. Check your blood pressure||
1977|019|W|regularly and tell your doctor if the results are high.||
1977|020|W|   Your doctor will monitor your blood pressure regularly during||
1977|021|W|treatment with this medication. Medications may be started or||
1977|022|W|adjusted to control your blood pressure.||
1977|023|B|||
1977|024|U|USES:  This medication is used by men who do not make enough of a||
1977|025|U|natural substance called testosterone (hypogonadism).||
1977|026|U|Testosterone belongs to a class of drugs known as androgens.||
1977|027|U|Testosterone helps the body to develop and maintain the male||
1977|028|U|sexual characteristics (masculinity), such as a deep voice and||
1977|029|U|body hair. It also helps to maintain muscle and prevent bone||
1977|030|U|loss, and is necessary for natural sexual ability/desire.||
1977|031|U|   This drug should not be used by women.||
1977|032|B|||
1977|033|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
1977|034|H|provided by your pharmacist before you start using testosterone||
1977|035|H|and each time you get a refill. Ask your health care professional||
1977|036|H|how to prepare and use this medication. If you have any||
1977|037|H|questions, ask your doctor or pharmacist.||
1977|038|H|   Inject this medication under the skin as directed by your||
1977|039|H|doctor, usually once every week. The injection is given in the||
1977|040|H|abdomen. The dosage is based on your medical condition,||
1977|041|H|testosterone blood levels, and response to treatment.||
1977|042|H|   Before using, check this product for particles or||
1977|043|H|discoloration. If either is present, do not use the liquid.||
1977|044|H|Before injecting each dose, clean the skin you are going to||
1977|045|H|inject into (the injection site) with rubbing alcohol. Change the||
1977|046|H|injection site each time to lessen injury under the skin. To||
1977|047|H|lessen bruising, do not rub the injection site after a shot.||
1977|048|H|Learn how to store and discard medical supplies safely.||
1977|049|H|   Use this medication regularly to get the most benefit from it.||
1977|050|H|To help you remember, use it on the same day each week. Mark your||
1977|051|H|calendar with a reminder.||
1977|052|H|   Misuse or abuse of testosterone can cause serious side effects||
1977|053|H|such as heart disease (including heart attack), stroke, liver||
1977|054|H|disease, mental/mood problems, abnormal drug-seeking behavior, or||
1977|055|H|improper bone growth (in adolescents). Do not increase your dose||
1977|056|H|or use this drug more often or for longer than prescribed. When||
1977|057|H|testosterone is misused or abused, you may have withdrawal||
1977|058|H|symptoms (such as depression, irritability, tiredness) when you||
1977|059|H|suddenly stop using the drug. These symptoms may last from weeks||
1977|060|H|to months.||
1977|061|H|   Tell your doctor if your condition does not get better or if||
1977|062|H|it gets worse.||
1977|063|B|||
1977|064|S|SIDE EFFECTS:  See also Warning section.||
1977|065|S|   Headache, changes in sexual interest, oily skin, hair loss,||
1977|066|S|and acne may occur. Pain, bruising, or bleeding at the injection||
1977|067|S|site may also occur. If any of these effects last or get worse,||
1977|068|S|tell your doctor or pharmacist promptly.||
1977|069|S|   Remember that this medication has been prescribed because your||
1977|070|S|doctor has judged that the benefit to you is greater than the||
1977|071|S|risk of side effects. Many people using this medication do not||
1977|072|S|have serious side effects.||
1977|073|S|   Tell your doctor right away if you have any serious side||
1977|074|S|effects, including: trouble urinating, increased urination||
1977|075|S|(especially at night), mental/mood changes (such as anxiety,||
1977|076|S|depression, hostility), interrupted breathing during sleep,||
1977|077|S|daytime drowsiness, signs of liver problems (such as||
1977|078|S|nausea/vomiting that doesn't stop, loss of appetite,||
1977|079|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1977|080|S|swelling hands/ankles/feet, breast pain/enlargement, frequent||
1977|081|S|erections, fast/irregular heartbeat.||
1977|082|S|   Get medical help right away if you have any very serious side||
1977|083|S|effects, including: shortness of breath/rapid breathing,||
1977|084|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
1977|085|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
1977|086|S|sudden/severe headaches, trouble speaking, weakness on one side||
1977|087|S|of the body, sudden vision changes.||
1977|088|S|   Rarely, males may have a painful or prolonged erection lasting||
1977|089|S|4 or more hours. If this occurs, stop using this drug and get||
1977|090|S|medical help right away, or permanent problems could occur.||
1977|091|S|   A very serious allergic reaction to this drug is rare.||
1977|092|S|However, get medical help right away if you notice any symptoms||
1977|093|S|of a serious allergic reaction, including: rash, itching/swelling||
1977|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1977|095|S|breathing.||
1977|096|S|   This is not a complete list of possible side effects. If you||
1977|097|S|notice other effects not listed above, contact your doctor or||
1977|098|S|pharmacist.||
1977|099|S|   In the US -||
1977|100|S|   Call your doctor for medical advice about side effects. You||
1977|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1977|102|S|www.fda.gov/medwatch.||
1977|103|S|   In Canada - Call your doctor for medical advice about side||
1977|104|S|effects. You may report side effects to Health Canada at||
1977|105|S|1-866-234-2345.||
1977|106|B|||
1977|107|P|PRECAUTIONS:  Before using testosterone, tell your doctor or||
1977|108|P|pharmacist if you are allergic to it; or if you have any other||
1977|109|P|allergies. This product may contain inactive ingredients (such as||
1977|110|P|sesame oil), which can cause allergic reactions or other||
1977|111|P|problems. Talk to your pharmacist for more details.||
1977|112|P|   Before using this medication, tell your doctor or pharmacist||
1977|113|P|your medical history, especially of: cancer (especially prostate||
1977|114|P|or breast cancer), prostate problems (such as enlarged prostate||
1977|115|P|or BPH), blood clots (such as in the legs, lungs), heart problems||
1977|116|P|(such as heart failure, heart attack), stroke, kidney problems,||
1977|117|P|liver problems, high cholesterol, high blood pressure, breathing||
1977|118|P|trouble during sleep (sleep apnea), diabetes.||
1977|119|P|   If you have diabetes, this product may affect your blood||
1977|120|P|sugar. Check your blood sugar regularly as directed and share the||
1977|121|P|results with your doctor. Tell your doctor right away if you have||
1977|122|P|symptoms of low blood sugar. Your doctor may need to adjust your||
1977|123|P|diabetes medication, exercise program, or diet.||
1977|124|P|   Before having surgery, tell your doctor or dentist about all||
1977|125|P|the products you use (including prescription drugs,||
1977|126|P|nonprescription drugs, and herbal products).||
1977|127|P|   Children may be more sensitive to the side effects of this||
1977|128|P|drug. In children, it may affect bone growth. Monitor your||
1977|129|P|child's height periodically.||
1977|130|P|   Older adults may be more sensitive to the side effects of this||
1977|131|P|drug, especially prostate problems.||
1977|132|P|   This medication can affect fertility in males. Ask your doctor||
1977|133|P|for more details.||
1977|134|P|   This medication should not be used by women, especially during||
1977|135|P|pregnancy or breastfeeding. It may harm an unborn or||
1977|136|P|breastfeeding baby. Consult your doctor for more details.||
1977|137|B|||
1977|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1977|139|I|medications work or increase your risk for serious side effects.||
1977|140|I|This document does not contain all possible drug interactions.||
1977|141|I|Keep a list of all the products you use (including||
1977|142|I|prescription/nonprescription drugs and herbal products) and share||
1977|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
1977|144|I|the dosage of any medicines without your doctor's approval.||
1977|145|I|   Some products that may interact with this drug are: "blood||
1977|146|I|thinners" (such as warfarin).||
1977|147|I|   This medication may interfere with certain lab tests (such as||
1977|148|I|thyroid tests), possibly causing false test results. Make sure||
1977|149|I|lab personnel and all your doctors know you use this drug.||
1977|150|B|||
1977|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1977|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1977|153|O|poison control center right away. US residents can call||
1977|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1977|155|B|||
1977|156|N|NOTES:  Do not share this medication with others. Sharing it is||
1977|157|N|against the law.||
1977|158|N|   Lab and/or medical tests (such as PSA, cholesterol,||
1977|159|N|hemoglobin/hematocrit, testosterone blood levels, prostate exams)||
1977|160|N|should be done while you are using this medication. Keep all||
1977|161|N|medical and lab appointments.||
1977|162|B|||
1977|163|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1977|164|D|If it is near the time of the next dose, skip the missed dose.||
1977|165|D|Use your next dose on your regular day. Do not double the dose to||
1977|166|D|catch up.||
1977|167|B|||
1977|168|R|STORAGE:  Store at room temperature. Do not refrigerate or||
1977|169|R|freeze. Keep the medication in original carton to protect from||
1977|170|R|light. Keep all medications away from children and pets.||
1977|171|R|   Do not flush medications down the toilet or pour them into a||
1977|172|R|drain unless instructed to do so. Properly discard this product||
1977|173|R|when it is expired or no longer needed. Consult your pharmacist||
1977|174|R|or local waste disposal company.||
1977|175|B|||
1977|176|A|Information last revised October 2024.||
1977|177|A|Copyright(c) 2025 First Databank, Inc.||
1977|178|B|||
1978|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1978|002|Z|does NOT have all possible information about this product. This||
1978|003|Z|information does not assure that this product is safe, effective,||
1978|004|Z|or appropriate for you. This information is not individual||
1978|005|Z|medical advice and does not substitute for the advice of your||
1978|006|Z|health care professional. Always ask your health care||
1978|007|Z|professional for complete information about this product and your||
1978|008|Z|specific health needs.||
1978|009|B|||
1978|010|T|REVEFENACIN SOLUTION - INHALATION||
1978|011|F|(REV-e-FEN-a-sin)||
1978|012|B|||
1978|013|C|COMMON BRAND NAME(S): Yupelri||
1978|014|B|||
1978|015|U|USES:  Revefenacin is a long-term medication used to treat an||
1978|016|U|ongoing lung disease, chronic obstructive pulmonary disease||
1978|017|U|(COPD). It must be used regularly to reduce and prevent symptoms||
1978|018|U|such as shortness of breath, cough, and wheezing. This medication||
1978|019|U|belongs to a class of drugs known as anticholinergics. It works||
1978|020|U|by relaxing the muscles around the airways so that they open up||
1978|021|U|and you can breathe more easily.||
1978|022|U|   Revefenacin does not work right away and should not be used to||
1978|023|U|relieve sudden breathing problems. If wheezing or sudden||
1978|024|U|shortness of breath occurs, use your quick-relief inhaler as||
1978|025|U|prescribed.||
1978|026|B|||
1978|027|H|HOW TO USE:  Read the Patient Information Leaflet and||
1978|028|H|Instructions for Use provided by your pharmacist before you start||
1978|029|H|using revefenacin and each time you get a refill. This medication||
1978|030|H|is used with a special machine called a nebulizer that changes||
1978|031|H|the solution to a fine mist that you inhale. Learn how to||
1978|032|H|prepare, use, and care for the nebulizer properly. If you have||
1978|033|H|any questions, ask your doctor, pharmacist, or respiratory||
1978|034|H|therapist.||
1978|035|H|   This product should be clear and colorless. Before using,||
1978|036|H|check this product for particles or discoloration. If either is||
1978|037|H|present, do not use the liquid.||
1978|038|H|   Inhale this medication into your lungs using the nebulizer as||
1978|039|H|directed by your doctor, usually once daily. Do not mix with||
1978|040|H|other medicines in the nebulizer. Avoid getting this medication||
1978|041|H|into your eyes. It may cause eye pain/irritation, temporary||
1978|042|H|blurred vision, and other vision changes. Each treatment usually||
1978|043|H|takes about 8 minutes. Use this medication only with the||
1978|044|H|nebulizer. Do not swallow or inject the solution. Clean the||
1978|045|H|nebulizer after every use according to the manufacturer's||
1978|046|H|directions.||
1978|047|H|   If you are using other inhaled medications at the same time,||
1978|048|H|wait at least one minute between the use of each medication.||
1978|049|H|   Use this medication regularly to get the most benefit from it.||
1978|050|H|To help you remember, use it at the same time each day. Do not||
1978|051|H|increase your dose or use this medication more often than||
1978|052|H|directed.||
1978|053|H|   Learn which of your inhalers/medications you should use every||
1978|054|H|day and which you should use if your breathing suddenly worsens||
1978|055|H|(quick-relief drugs). Ask your doctor ahead of time what you||
1978|056|H|should do if you have new or worsening cough or shortness of||
1978|057|H|breath, wheezing, increased sputum, waking up at night with||
1978|058|H|trouble breathing, if you use your quick-relief inhaler more||
1978|059|H|often, or if your quick-relief inhaler does not seem to be||
1978|060|H|working well. Learn when you can treat sudden breathing problems||
1978|061|H|by yourself and when you must get medical help right away.||
1978|062|H|   Tell your doctor if your symptoms do not get better or if they||
1978|063|H|get worse.||
1978|064|B|||
1978|065|S|SIDE EFFECTS:  Runny/stuffy nose may occur. If this effect lasts||
1978|066|S|or gets worse, tell your doctor or pharmacist promptly.||
1978|067|S|   Remember that this medication has been prescribed because your||
1978|068|S|doctor has judged that the benefit to you is greater than the||
1978|069|S|risk of side effects. Many people using this medication do not||
1978|070|S|have serious side effects.||
1978|071|S|   Rarely, this medication may cause sudden severe worsening of||
1978|072|S|breathing problems right after you use it. If this occurs, use||
1978|073|S|your quick-relief inhaler and get medical help right away.||
1978|074|S|   Tell your doctor right away if you have any serious side||
1978|075|S|effects, including: difficulty urinating, painful urination.||
1978|076|S|   Get medical help right away if you have any very serious side||
1978|077|S|effects, including: eye pain/swelling/redness, vision changes||
1978|078|S|(such as seeing rainbows around lights at night, blurred vision).||
1978|079|S|   A very serious allergic reaction to this product is rare.||
1978|080|S|However, get medical help right away if you notice any symptoms||
1978|081|S|of a serious allergic reaction, including: rash, itching/swelling||
1978|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1978|083|S|breathing.||
1978|084|S|   This is not a complete list of possible side effects. If you||
1978|085|S|notice other effects not listed above, contact your doctor or||
1978|086|S|pharmacist.||
1978|087|S|   In the US -||
1978|088|S|   Call your doctor for medical advice about side effects. You||
1978|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1978|090|S|www.fda.gov/medwatch.||
1978|091|S|   In Canada - Call your doctor for medical advice about side||
1978|092|S|effects. You may report side effects to Health Canada at||
1978|093|S|1-866-234-2345.||
1978|094|B|||
1978|095|P|PRECAUTIONS:  Before using revefenacin, tell your doctor or||
1978|096|P|pharmacist if you are allergic to it; or if you have any other||
1978|097|P|allergies. This product may contain inactive ingredients, which||
1978|098|P|can cause allergic reactions or other problems. Talk to your||
1978|099|P|pharmacist for more details.||
1978|100|P|   Before using this medication, tell your doctor or pharmacist||
1978|101|P|your medical history, especially of: personal or family history||
1978|102|P|of glaucoma (angle-closure type), problems with urinating (such||
1978|103|P|as due to blockage/enlarged prostate), liver problems.||
1978|104|P|   Before having surgery, tell your doctor or dentist about all||
1978|105|P|the products you use (including prescription drugs,||
1978|106|P|nonprescription drugs, and herbal products).||
1978|107|P|   During pregnancy, this medication should be used only when||
1978|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
1978|109|P|   It is unknown if this medication passes into breast milk.||
1978|110|P|Consult your doctor before breastfeeding.||
1978|111|B|||
1978|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1978|113|I|medications work or increase your risk for serious side effects.||
1978|114|I|This document does not contain all possible drug interactions.||
1978|115|I|Keep a list of all the products you use (including||
1978|116|I|prescription/nonprescription drugs and herbal products) and share||
1978|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
1978|118|I|the dosage of any medicines without your doctor's approval.||
1978|119|B|||
1978|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1978|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1978|122|O|poison control center right away. US residents can call||
1978|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1978|124|O|Symptoms of overdose may include: nausea, vomiting, dizziness,||
1978|125|O|lightheadedness.||
1978|126|B|||
1978|127|N|NOTES:  Do not share this medication with others.||
1978|128|N|   If you smoke, quitting is the most important step you can take||
1978|129|N|to treat COPD. Talk with your doctor or pharmacist about programs||
1978|130|N|and products that can help you quit.||
1978|131|N|   Because the flu virus can worsen breathing problems, ask your||
1978|132|N|doctor or pharmacist if you should have a flu shot every year.||
1978|133|N|   Lab/medical tests (such as lung function) should be done while||
1978|134|N|you are using this medication. Keep all medical and lab||
1978|135|N|appointments.||
1978|136|B|||
1978|137|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1978|138|D|If it is near the time of the next dose, skip the missed dose.||
1978|139|D|Use your next dose at the regular time. Do not double the dose to||
1978|140|D|catch up.||
1978|141|B|||
1978|142|R|STORAGE:  Store at room temperature away from light and heat.||
1978|143|R|Keep the medication in the foil pouch until ready to use. Discard||
1978|144|R|any unused portion after use. Keep all medications away from||
1978|145|R|children and pets.||
1978|146|R|   Do not flush medications down the toilet or pour them into a||
1978|147|R|drain unless instructed to do so. Properly discard this product||
1978|148|R|when it is expired or no longer needed. Consult your pharmacist||
1978|149|R|or local waste disposal company.||
1978|150|B|||
1978|151|M|MEDICAL ALERT:  Your condition can cause complications in a||
1978|152|M|medical emergency. For information about enrolling in MedicAlert,||
1978|153|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1978|154|B|||
1978|155|A|Information last revised January 2025.||
1978|156|A|Copyright(c) 2025 First Databank, Inc.||
1978|157|B|||
1979|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1979|002|Z|does NOT have all possible information about this product. This||
1979|003|Z|information does not assure that this product is safe, effective,||
1979|004|Z|or appropriate for you. This information is not individual||
1979|005|Z|medical advice and does not substitute for the advice of your||
1979|006|Z|health care professional. Always ask your health care||
1979|007|Z|professional for complete information about this product and your||
1979|008|Z|specific health needs.||
1979|009|B|||
1979|010|T|ARIPIPRAZOLE TABLET WITH SENSOR AND PATCH - KIT||
1979|011|F|(AR-i-PIP-ra-zole)||
1979|012|B|||
1979|013|C|COMMON BRAND NAME(S): Abilify Mycite||
1979|014|B|||
1979|015|W|WARNING:  If you are using aripiprazole in combination with other||
1979|016|W|medication to treat depression, also carefully read the drug||
1979|017|W|information for the other medication.||
1979|018|W|   There may be a slightly increased risk of serious, possibly||
1979|019|W|fatal side effects (such as stroke, heart failure, fast/irregular||
1979|020|W|heartbeat, pneumonia) when this medication is used by older||
1979|021|W|adults with dementia. This medication is not approved for the||
1979|022|W|treatment of dementia-related behavior problems. Discuss the||
1979|023|W|risks and benefits of this medication, as well as other effective||
1979|024|W|and possibly safer treatments for dementia-related behavior||
1979|025|W|problems, with the doctor.||
1979|026|B|||
1979|027|U|USES:  This product is a combination of aripiprazole tablets and||
1979|028|U|a patch. Each tablet has an embedded sensor, and the patch||
1979|029|U|detects the signal from the tablet sensor. You will use it with a||
1979|030|U|smartphone application (app). Your health care professional or||
1979|031|U|caregiver will also be able to see data from the tablet sensor in||
1979|032|U|a web-based portal. Aripiprazole is used to treat certain||
1979|033|U|mental/mood disorders (such as bipolar disorder, schizophrenia,||
1979|034|U|Tourette's syndrome, and irritability associated with autistic||
1979|035|U|disorder). It may also be used in combination with other||
1979|036|U|medication to treat depression. Aripiprazole belongs to a class||
1979|037|U|of drugs known as atypical antipsychotics. It works by helping to||
1979|038|U|restore the balance of certain natural substances in the brain.||
1979|039|B|||
1979|040|V|OTHER USES:  This section contains uses of this drug that are not||
1979|041|V|listed in the approved professional labeling for the drug but||
1979|042|V|that may be prescribed by your health care professional. Use this||
1979|043|V|drug for a condition that is listed in this section only if it||
1979|044|V|has been so prescribed by your health care professional.||
1979|045|V|   This medication may also be used for obsessive-compulsive||
1979|046|V|disorder.||
1979|047|B|||
1979|048|H|HOW TO USE:  Read the Medication Guide provided by your||
1979|049|H|pharmacist before you start taking aripiprazole and each time you||
1979|050|H|get a refill. Before using this product, download the smartphone||
1979|051|H|app and follow all the Instructions for Use. Make sure the app||
1979|052|H|works with your smartphone. If you have any questions, ask your||
1979|053|H|doctor or pharmacist.||
1979|054|H|   Take this medication by mouth with or without food as directed||
1979|055|H|by your doctor, usually once daily. Swallow this medication||
1979|056|H|whole. Do not split, crush, or chew the tablets. The dosage is||
1979|057|H|based on your medical condition, response to treatment, age, and||
1979|058|H|other medications you may be taking. Be sure to tell your doctor||
1979|059|H|and pharmacist about all the products you use (including||
1979|060|H|prescription drugs, nonprescription drugs, and herbal products).||
1979|061|H|   Apply the patch when instructed to do so by the smartphone||
1979|062|H|app. The patch should be applied just above the lower edge of||
1979|063|H|your rib cage. Do not place the patch on skin that is scraped,||
1979|064|H|cracked, or irritated. Change the placement each time so the||
1979|065|H|patch is not on the same spot where the last patch was placed.||
1979|066|H|Leave the patch on when showering, swimming, or exercising. The||
1979|067|H|smartphone app will tell you when to change the patch (weekly or||
1979|068|H|sooner). If you have skin irritation, remove the patch and tell||
1979|069|H|your doctor right away. If you are going to have an MRI test, you||
1979|070|H|will need to remove your patch before the test and apply a new||
1979|071|H|patch afterward. (See also Precautions section.)||
1979|072|H|   The tablet is usually detected by the patch and smartphone app||
1979|073|H|within 30 minutes after you take it, but it could take as long as||
1979|074|H|2 hours. Sometimes the tablet might not be detected at all. If||
1979|075|H|this happens, do not repeat your dose.||
1979|076|H|   To reduce your risk of side effects, your doctor may direct||
1979|077|H|you to start this medication at a low dose and gradually increase||
1979|078|H|your dose. Follow your doctor's instructions carefully. Do not||
1979|079|H|increase your dose or use this drug more often or for longer than||
1979|080|H|prescribed. Your condition will not improve any faster, and your||
1979|081|H|risk of side effects will increase.||
1979|082|H|   It may take several weeks before you get the full benefit of||
1979|083|H|this drug. Use this medication regularly to get the most benefit||
1979|084|H|from it. To help you remember, take it at the same time each day.||
1979|085|H|   Keep taking this medication even if you feel well. Do not stop||
1979|086|H|taking this medication without consulting your doctor. Some||
1979|087|H|conditions may become worse when this drug is suddenly stopped.||
1979|088|H|Your dose may need to be gradually decreased.||
1979|089|H|   Tell your doctor if your condition does not get better or if||
1979|090|H|it gets worse.||
1979|091|B|||
1979|092|S|SIDE EFFECTS:  See also Warning section.||
1979|093|S|   Dizziness, lightheadedness, drowsiness, nausea, vomiting,||
1979|094|S|tiredness, excess saliva/drooling, blurred vision, weight gain,||
1979|095|S|constipation, headache, and trouble sleeping may occur. If any of||
1979|096|S|these effects last or get worse, tell your doctor or pharmacist||
1979|097|S|promptly.||
1979|098|S|   Dizziness and lightheadedness can increase the risk of||
1979|099|S|falling. Get up slowly when rising from a sitting or lying||
1979|100|S|position.||
1979|101|S|   Remember that this medication has been prescribed because your||
1979|102|S|doctor has judged that the benefit to you is greater than the||
1979|103|S|risk of side effects. Many people using this medication do not||
1979|104|S|have serious side effects.||
1979|105|S|   Tell your doctor right away if you have any serious side||
1979|106|S|effects, including: fainting, mental/mood changes (such as||
1979|107|S|increased anxiety, depression, suicidal thoughts), trouble||
1979|108|S|swallowing, restlessness (especially in the legs), shaking||
1979|109|S|(tremor), muscle spasm, mask-like expression of the face,||
1979|110|S|seizures, trouble controlling certain urges (such as gambling,||
1979|111|S|sex, eating or shopping), interrupted breathing during sleep.||
1979|112|S|   This medication may rarely make your blood sugar rise, which||
1979|113|S|can cause or worsen diabetes. Tell your doctor right away if you||
1979|114|S|have symptoms of high blood sugar such as increased||
1979|115|S|thirst/urination. If you already have diabetes, check your blood||
1979|116|S|sugar regularly as directed and share the results with your||
1979|117|S|doctor. Your doctor may need to adjust your diabetes medication,||
1979|118|S|exercise program, or diet.||
1979|119|S|   This medication may rarely cause a condition called tardive||
1979|120|S|dyskinesia. In some cases, this condition may be permanent. Tell||
1979|121|S|your doctor right away if you develop any unusual uncontrolled||
1979|122|S|movements (especially of the face, mouth, tongue, arms, or legs).||
1979|123|S|   This medication may rarely cause a very serious condition||
1979|124|S|called neuroleptic malignant syndrome (NMS). Get medical help||
1979|125|S|right away if you have any of the following symptoms: fever,||
1979|126|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
1979|127|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
1979|128|S|signs of kidney problems (such as change in the amount of urine).||
1979|129|S|   A very serious allergic reaction to this drug is rare.||
1979|130|S|However, get medical help right away if you notice any symptoms||
1979|131|S|of a serious allergic reaction, including: fever, swollen lymph||
1979|132|S|nodes, rash, itching/swelling (especially of the||
1979|133|S|face/tongue/throat), severe dizziness, trouble breathing.||
1979|134|S|   This is not a complete list of possible side effects. If you||
1979|135|S|notice other effects not listed above, contact your doctor or||
1979|136|S|pharmacist.||
1979|137|S|   In the US -||
1979|138|S|   Call your doctor for medical advice about side effects. You||
1979|139|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1979|140|S|www.fda.gov/medwatch.||
1979|141|S|   In Canada - Call your doctor for medical advice about side||
1979|142|S|effects. You may report side effects to Health Canada at||
1979|143|S|1-866-234-2345.||
1979|144|B|||
1979|145|P|PRECAUTIONS:  See also Warning section.||
1979|146|P|   Before taking aripiprazole, tell your doctor or pharmacist if||
1979|147|P|you are allergic to it; or if you have any other allergies. This||
1979|148|P|product may contain inactive ingredients, which can cause||
1979|149|P|allergic reactions or other problems. Talk to your pharmacist for||
1979|150|P|more details.||
1979|151|P|   Before using this medication, tell your doctor or pharmacist||
1979|152|P|your medical history, especially of: problems with blood flow in||
1979|153|P|the brain (such as cerebrovascular disease, stroke), diabetes||
1979|154|P|(including family history), heart problems (such as low blood||
1979|155|P|pressure, coronary artery disease, heart failure, irregular||
1979|156|P|heartbeat), nervous system problems (such as dementia, NMS,||
1979|157|P|seizures), obesity, low white blood cell count (including history||
1979|158|P|of low white blood cell count caused by medications), swallowing||
1979|159|P|problems, breathing trouble during sleep (sleep apnea).||
1979|160|P|   This drug may make you dizzy or drowsy or cause blurred||
1979|161|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
1979|162|P|or drowsy. Do not drive, use machinery, or do anything that needs||
1979|163|P|alertness or clear vision until you can do it safely. Avoid||
1979|164|P|alcoholic beverages. Talk to your doctor if you are using||
1979|165|P|marijuana (cannabis).||
1979|166|P|   This medication may make you sweat less, making you more||
1979|167|P|likely to get heat stroke. Avoid doing things that may cause you||
1979|168|P|to overheat, such as hard work or exercise in hot weather, or||
1979|169|P|using hot tubs. When the weather is hot, drink a lot of fluids||
1979|170|P|and dress lightly. If you overheat, quickly look for a place to||
1979|171|P|cool down and rest. Get medical help right away if you have a||
1979|172|P|fever that does not go away, mental/mood changes, headache, or||
1979|173|P|dizziness.||
1979|174|P|   If you are going to have an MRI test, tell testing personnel||
1979|175|P|that you are using this patch. This patch may contain metals that||
1979|176|P|can cause serious burns during an MRI. You will need to remove||
1979|177|P|your patch before the test and apply a new patch afterward.||
1979|178|P|   Older adults may be more sensitive to the side effects of this||
1979|179|P|drug, especially seizures, drowsiness, dizziness,||
1979|180|P|lightheadedness, confusion, tardive dyskinesia, swallowing||
1979|181|P|problems, and other serious (rarely fatal) side effects. (See||
1979|182|P|also Warning section.) Drowsiness, dizziness, lightheadedness,||
1979|183|P|and confusion can increase the risk of falling.||
1979|184|P|   Before having surgery, tell your doctor or dentist about all||
1979|185|P|the products you use (including prescription drugs,||
1979|186|P|nonprescription drugs, and herbal products).||
1979|187|P|   During pregnancy, this medication should be used only when||
1979|188|P|clearly needed. Babies born to mothers who have used this drug||
1979|189|P|during the last 3 months of pregnancy may rarely develop symptoms||
1979|190|P|such as muscle stiffness or shakiness, drowsiness,||
1979|191|P|feeding/breathing difficulties, or constant crying. If you notice||
1979|192|P|any of these symptoms in your newborn especially during their||
1979|193|P|first month, tell the doctor promptly.||
1979|194|P|   Since untreated mental/mood problems (such as bipolar||
1979|195|P|disorder, schizophrenia) can be a serious condition, do not stop||
1979|196|P|taking this medication unless directed by your doctor. If you are||
1979|197|P|planning pregnancy, become pregnant, or think you may be||
1979|198|P|pregnant, discuss with your doctor right away about the benefits||
1979|199|P|and risks of using this medication during pregnancy.||
1979|200|P|   This medication passes into breast milk. Consult your doctor||
1979|201|P|before breastfeeding.||
1979|202|B|||
1979|203|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1979|204|I|medications work or increase your risk for serious side effects.||
1979|205|I|This document does not contain all possible drug interactions.||
1979|206|I|Keep a list of all the products you use (including||
1979|207|I|prescription/nonprescription drugs and herbal products) and share||
1979|208|I|it with your doctor and pharmacist. Do not start, stop, or change||
1979|209|I|the dosage of any medicines without your doctor's approval.||
1979|210|I|   A product that may interact with this drug is: metoclopramide.||
1979|211|I|   Tell your doctor or pharmacist if you are using other products||
1979|212|I|that cause drowsiness such as opioid pain or cough relievers||
1979|213|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
1979|214|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
1979|215|I|zolpidem), muscle relaxants (such as carisoprodol,||
1979|216|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1979|217|I|diphenhydramine).||
1979|218|I|   Check the labels on all your medicines (such as allergy or||
1979|219|I|cough-and-cold products) because they may contain ingredients||
1979|220|I|that cause drowsiness. Ask your pharmacist about using those||
1979|221|I|products safely.||
1979|222|B|||
1979|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1979|224|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1979|225|O|poison control center right away. US residents can call||
1979|226|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1979|227|O|Symptoms of overdose may include: very fast heartbeat, loss of||
1979|228|O|consciousness.||
1979|229|B|||
1979|230|N|NOTES:  Do not share this medication with others.||
1979|231|N|   Lab and/or medical tests (such as blood sugar, weight,||
1979|232|N|cholesterol/triglyceride levels) may be done while you are taking||
1979|233|N|this medication. Keep all medical and lab appointments.||
1979|234|B|||
1979|235|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1979|236|D|remember. If it is near the time of the next dose, skip the||
1979|237|D|missed dose. Take your next dose at the regular time. Do not||
1979|238|D|double the dose to catch up.||
1979|239|B|||
1979|240|R|STORAGE:  Store the tablets at room temperature away from light||
1979|241|R|and moisture. Store the patches (wearable sensor) in a cool place||
1979|242|R|or at room temperature away from light and moisture. Check the||
1979|243|R|manufacturer's information for recommended storage details. Do||
1979|244|R|not store in the bathroom. Keep all medications away from||
1979|245|R|children and pets.||
1979|246|R|   Do not flush medications down the toilet or pour them into a||
1979|247|R|drain unless instructed to do so. Properly discard this product||
1979|248|R|when it is expired or no longer needed. Consult your pharmacist||
1979|249|R|or local waste disposal company.||
1979|250|B|||
1979|251|A|Information last revised May 2024.||
1979|252|A|Copyright(c) 2025 First Databank, Inc.||
1979|253|B|||
1980|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1980|002|Z|does NOT have all possible information about this product. This||
1980|003|Z|information does not assure that this product is safe, effective,||
1980|004|Z|or appropriate for you. This information is not individual||
1980|005|Z|medical advice and does not substitute for the advice of your||
1980|006|Z|health care professional. Always ask your health care||
1980|007|Z|professional for complete information about this product and your||
1980|008|Z|specific health needs.||
1980|009|B|||
1980|010|T|LOTEPREDNOL 1% SUSPENSION - OPHTHALMIC||
1980|011|F|(LOE-te-PRED-nol)||
1980|012|B|||
1980|013|C|COMMON BRAND NAME(S): Inveltys||
1980|014|B|||
1980|015|U|USES:  This medication is used after eye surgery to help relieve||
1980|016|U|pain and swelling (inflammation). Loteprednol belongs to a class||
1980|017|U|of drugs known as corticosteroids.||
1980|018|B|||
1980|019|H|HOW TO USE:  Read the manufacturer's Instructions for Use if||
1980|020|H|available from your pharmacist before you start using loteprednol||
1980|021|H|and each time you get a refill. If you have any questions, ask||
1980|022|H|your doctor or pharmacist.||
1980|023|H|   Use this medication in the affected eye(s) as directed by your||
1980|024|H|doctor, usually twice daily.||
1980|025|H|   To apply eye drops, wash hands first. Before using, shake the||
1980|026|H|bottle well for 1 to 2 seconds. To avoid contamination, do not||
1980|027|H|touch the dropper tip or let it touch your eye or any other||
1980|028|H|surface.||
1980|029|H|   If you are wearing contact lenses, remove them before using||
1980|030|H|eye drops. Wait at least 15 minutes before replacing your contact||
1980|031|H|lenses. Tilt your head back, look upward, and pull down the lower||
1980|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1980|033|H|and place one drop into the pouch. Look downward, gently close||
1980|034|H|your eyes, and place one finger at the corner of your eye (near||
1980|035|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
1980|036|H|opening your eyes. This will prevent the medication from draining||
1980|037|H|out. Try not to blink or rub your eye. Repeat these steps if your||
1980|038|H|dose is for more than one drop. If directed to use this||
1980|039|H|medication in both eyes, repeat these steps for your other eye.||
1980|040|H|Do not rinse the dropper. Replace the dropper cap after each use.||
1980|041|H|   If you are using another kind of eye medication (such as drops||
1980|042|H|or ointments), wait at least 5 to 10 minutes before applying||
1980|043|H|other medications. Use eye drops before eye ointments to allow||
1980|044|H|the drops to enter the eye.||
1980|045|H|   Wait several minutes for your vision to clear before driving||
1980|046|H|or operating machinery.||
1980|047|H|   Use this medication regularly to get the most benefit from it.||
1980|048|H|To help you remember, use it at the same times each day.||
1980|049|H|   The dosage and length of treatment are based on your medical||
1980|050|H|condition and response to treatment. Continue to use this||
1980|051|H|medication for the full time prescribed. Do not use this||
1980|052|H|medication more often or for longer than prescribed. Doing so may||
1980|053|H|increase your risk of side effects.||
1980|054|H|   Do not use this product if it becomes contaminated (for||
1980|055|H|example, drops turn a dark color). Use of contaminated eye||
1980|056|H|medication can cause infection, serious damage to the eye, and||
1980|057|H|loss of vision.||
1980|058|H|   Tell your doctor if your condition does not get better or if||
1980|059|H|it gets worse.||
1980|060|B|||
1980|061|S|SIDE EFFECTS:  Eye discomfort, redness, or temporary blurred||
1980|062|S|vision may occur. If any of these effects last or get worse, tell||
1980|063|S|your doctor or pharmacist promptly.||
1980|064|S|   Remember that this medication has been prescribed because your||
1980|065|S|doctor has judged that the benefit to you is greater than the||
1980|066|S|risk of side effects. Many people using this medication do not||
1980|067|S|have serious side effects.||
1980|068|S|   Tell your doctor right away if you have any serious side||
1980|069|S|effects, including: vision changes (such as decreased vision),||
1980|070|S|eye pain.||
1980|071|S|   This medication may mask the signs of an eye infection. It may||
1980|072|S|also increase the risk of developing an eye infection, especially||
1980|073|S|with longer use. Tell your doctor right away if you have new or||
1980|074|S|worsening symptoms such as eye discharge/swelling/redness.||
1980|075|S|   A very serious allergic reaction to this drug is rare.||
1980|076|S|However, get medical help right away if you notice any symptoms||
1980|077|S|of a serious allergic reaction, including: rash, itching/swelling||
1980|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1980|079|S|breathing.||
1980|080|S|   This is not a complete list of possible side effects. If you||
1980|081|S|notice other effects not listed above, contact your doctor or||
1980|082|S|pharmacist.||
1980|083|S|   In the US -||
1980|084|S|   Call your doctor for medical advice about side effects. You||
1980|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1980|086|S|www.fda.gov/medwatch.||
1980|087|S|   In Canada - Call your doctor for medical advice about side||
1980|088|S|effects. You may report side effects to Health Canada at||
1980|089|S|1-866-234-2345.||
1980|090|B|||
1980|091|P|PRECAUTIONS:  Before using loteprednol, tell your doctor or||
1980|092|P|pharmacist if you are allergic to it; or if you have any other||
1980|093|P|allergies. This product may contain inactive ingredients, which||
1980|094|P|can cause allergic reactions or other problems. Talk to your||
1980|095|P|pharmacist for more details.||
1980|096|P|   Before using this medication, tell your doctor or pharmacist||
1980|097|P|your medical history, especially of: eye infections, cataracts,||
1980|098|P|glaucoma.||
1980|099|P|   After you apply this drug, your vision may become temporarily||
1980|100|P|blurred. Do not drive, use machinery, or do anything that needs||
1980|101|P|clear vision until you can do it safely.||
1980|102|P|   Before having surgery, tell your doctor or dentist about all||
1980|103|P|the products you use (including prescription drugs,||
1980|104|P|nonprescription drugs, and herbal products).||
1980|105|P|   During pregnancy, this medication should be used only when||
1980|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
1980|107|P|   It is unknown if this medication passes into breast milk.||
1980|108|P|Consult your doctor before breastfeeding.||
1980|109|B|||
1980|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1980|111|I|medications work or increase your risk for serious side effects.||
1980|112|I|This document does not contain all possible drug interactions.||
1980|113|I|Keep a list of all the products you use (including||
1980|114|I|prescription/nonprescription drugs and herbal products) and share||
1980|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
1980|116|I|the dosage of any medicines without your doctor's approval.||
1980|117|B|||
1980|118|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1980|119|O|has overdosed and has serious symptoms such as passing out or||
1980|120|O|trouble breathing, call 911. Otherwise, call a poison control||
1980|121|O|center right away. US residents can call 1-800-222-1222. Canada||
1980|122|O|residents can call 1-844-764-7669.||
1980|123|B|||
1980|124|N|NOTES:  Do not share this medication with others.||
1980|125|N|   This medication has been prescribed for your current condition||
1980|126|N|only. Do not use it later for another eye condition unless told||
1980|127|N|to do so by your doctor. A different medication may be necessary||
1980|128|N|in that case.||
1980|129|N|   Lab and/or medical tests (such as eye exams) may be done while||
1980|130|N|you are using this medication. Keep all medical and lab||
1980|131|N|appointments.||
1980|132|B|||
1980|133|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1980|134|D|If it is near the time of the next dose, skip the missed dose.||
1980|135|D|Use your next dose at the regular time. Do not double the dose to||
1980|136|D|catch up.||
1980|137|B|||
1980|138|R|STORAGE:  Store upright at room temperature. Do not freeze. Keep||
1980|139|R|all medications away from children and pets.||
1980|140|R|   Do not flush medications down the toilet or pour them into a||
1980|141|R|drain unless instructed to do so. Properly discard this product||
1980|142|R|when it is expired or no longer needed. Consult your pharmacist||
1980|143|R|or local waste disposal company.||
1980|144|B|||
1980|145|A|Information last revised September 2024.||
1980|146|A|Copyright(c) 2025 First Databank, Inc.||
1980|147|B|||
1981|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1981|002|Z|does NOT have all possible information about this product. This||
1981|003|Z|information does not assure that this product is safe, effective,||
1981|004|Z|or appropriate for you. This information is not individual||
1981|005|Z|medical advice and does not substitute for the advice of your||
1981|006|Z|health care professional. Always ask your health care||
1981|007|Z|professional for complete information about this product and your||
1981|008|Z|specific health needs.||
1981|009|B|||
1981|010|T|CLOBAZAM FILM - ORAL||
1981|011|F|(KLOE-ba-zam)||
1981|012|B|||
1981|013|C|COMMON BRAND NAME(S): Sympazan||
1981|014|B|||
1981|015|W|WARNING:  Clobazam has a risk for abuse and addiction, which can||
1981|016|W|lead to overdose and death. Taking this medication with alcohol||
1981|017|W|or other drugs that can cause drowsiness or breathing problems||
1981|018|W|(especially opioid medications such as codeine, hydrocodone) may||
1981|019|W|cause very serious side effects, including death. To lower your||
1981|020|W|risk, your doctor should have you take the smallest dose of||
1981|021|W|clobazam that works, and take it for the shortest possible time.||
1981|022|W|Be sure you know how to take clobazam and what other drugs you||
1981|023|W|should avoid taking with it. See also Drug Interactions section.||
1981|024|W|Get medical help right away if any of these very serious side||
1981|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
1981|026|W|severe drowsiness/dizziness, difficulty waking up.||
1981|027|W|   Suddenly stopping this medication may cause serious (possibly||
1981|028|W|fatal) withdrawal, especially if you have used it for a long time||
1981|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
1981|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
1981|031|W|you have any withdrawal symptoms such as headaches, trouble||
1981|032|W|sleeping, restlessness, hallucinations/confusion, depression,||
1981|033|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
1981|034|W|to months.||
1981|035|B|||
1981|036|U|USES:  This medication is used with other medications to help||
1981|037|U|control seizures. It belongs to a class of medications called||
1981|038|U|benzodiazepines, which act on the brain and nerves (central||
1981|039|U|nervous system) to produce a calming effect. This drug works by||
1981|040|U|enhancing the effects of a certain natural chemical in the body||
1981|041|U|(GABA).||
1981|042|B|||
1981|043|H|HOW TO USE:  See also Warning section.||
1981|044|H|   Read the Medication Guide and Instructions for Use provided by||
1981|045|H|your pharmacist before you start taking clobazam and each time||
1981|046|H|you get a refill. If you have any questions, ask your doctor or||
1981|047|H|pharmacist.||
1981|048|H|   Take this medication by mouth with or without food as directed||
1981|049|H|by your doctor, usually once or twice daily. If you are taking||
1981|050|H|this medication once daily, then take it at bedtime. If you are||
1981|051|H|taking this medication in divided doses, take the larger dose at||
1981|052|H|bedtime.||
1981|053|H|   The dosage is based on your age, weight, medical condition,||
1981|054|H|and response to treatment.||
1981|055|H|   Apply the medication on top of the tongue and let it dissolve.||
1981|056|H|Do not chew, spit, talk, or drink any liquids while the||
1981|057|H|medication is dissolving. Swallow saliva normally as the||
1981|058|H|medication is dissolving. If your dose is for more than one film,||
1981|059|H|let the first film fully dissolve before using the next film.||
1981|060|H|   Use this medication regularly to get the most benefit from it.||
1981|061|H|To help you remember, take it at the same time(s) each day.||
1981|062|H|   Though it helps many people, this medication may sometimes||
1981|063|H|cause addiction. This risk may be higher if you have a substance||
1981|064|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
1981|065|H|Take this medication exactly as prescribed to lower the risk of||
1981|066|H|addiction. Ask your doctor or pharmacist for more details.||
1981|067|H|   When this medication is used for a long time, it may not work||
1981|068|H|as well. Talk with your doctor if this medication stops working||
1981|069|H|well.||
1981|070|H|   Tell your doctor if your condition lasts or gets worse.||
1981|071|B|||
1981|072|S|SIDE EFFECTS:  See also Warning section.||
1981|073|S|   Drowsiness, dizziness, tiredness, constipation, cough,||
1981|074|S|drooling, or trouble sleeping may occur. If any of these effects||
1981|075|S|last or get worse, tell your doctor or pharmacist promptly.||
1981|076|S|   Remember that this medication has been prescribed because your||
1981|077|S|doctor has judged that the benefit to you is greater than the||
1981|078|S|risk of side effects. Many people using this medication do not||
1981|079|S|have serious side effects.||
1981|080|S|   Tell your doctor right away if you have any serious side||
1981|081|S|effects, including: mental/mood changes (such as agitation,||
1981|082|S|nervousness, confusion), muscle weakness, loss of coordination,||
1981|083|S|trouble speaking, painful urination.||
1981|084|S|   A small number of people who take anticonvulsants for any||
1981|085|S|condition (such as seizure, bipolar disorder, pain) may||
1981|086|S|experience depression, suicidal thoughts/attempts, or other||
1981|087|S|mental/mood problems. Tell your doctor right away if you or your||
1981|088|S|family/caregiver notice any unusual/sudden changes in your mood,||
1981|089|S|thoughts, or behavior including signs of depression, suicidal||
1981|090|S|thoughts/attempts, thoughts about harming yourself.||
1981|091|S|   Get medical help right away if you have any very serious side||
1981|092|S|effects, including: slow/shallow breathing.||
1981|093|S|   Clobazam may rarely cause very serious (possibly fatal) skin||
1981|094|S|reactions, especially during the first 8 weeks of treatment or||
1981|095|S|when restarting treatment with this medication. Get medical help||
1981|096|S|right away if you develop any of the following symptoms: skin||
1981|097|S|rash/blisters/peeling, itching, or mouth sores. If you have a||
1981|098|S|very serious skin reaction and your doctor says it was caused by||
1981|099|S|clobazam, you should not take the medication again. Ask your||
1981|100|S|doctor or pharmacist for more details.||
1981|101|S|   A very serious allergic reaction to this drug is rare.||
1981|102|S|However, get medical help right away if you notice any symptoms||
1981|103|S|of a serious allergic reaction, including: fever, swollen lymph||
1981|104|S|nodes, rash, itching/swelling (especially of the||
1981|105|S|face/tongue/throat), severe dizziness, trouble breathing.||
1981|106|S|   This is not a complete list of possible side effects. If you||
1981|107|S|notice other effects not listed above, contact your doctor or||
1981|108|S|pharmacist.||
1981|109|S|   In the US -||
1981|110|S|   Call your doctor for medical advice about side effects. You||
1981|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1981|112|S|www.fda.gov/medwatch.||
1981|113|S|   In Canada - Call your doctor for medical advice about side||
1981|114|S|effects. You may report side effects to Health Canada at||
1981|115|S|1-866-234-2345.||
1981|116|B|||
1981|117|P|PRECAUTIONS:  Before taking clobazam, tell your doctor or||
1981|118|P|pharmacist if you are allergic to it; or to other benzodiazepines||
1981|119|P|(such as diazepam, lorazepam); or if you have any other||
1981|120|P|allergies. This product may contain inactive ingredients, which||
1981|121|P|can cause allergic reactions or other problems. Talk to your||
1981|122|P|pharmacist for more details.||
1981|123|P|   Before using this medication, tell your doctor or pharmacist||
1981|124|P|your medical history, especially of: muscle disorders (such as||
1981|125|P|myasthenia gravis, weakness, loss of coordination), glaucoma,||
1981|126|P|liver disease, personal or family history of a substance use||
1981|127|P|disorder (such as overuse of or addiction to drugs/alcohol),||
1981|128|P|mental/mood disorders (such as depression, psychosis), breathing||
1981|129|P|problems (such as asthma, chronic obstructive pulmonary||
1981|130|P|disease-COPD, sleep apnea).||
1981|131|P|   Before having surgery, tell your doctor or dentist about all||
1981|132|P|the products you use (including prescription drugs,||
1981|133|P|nonprescription drugs, and herbal products).||
1981|134|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
1981|135|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
1981|136|P|machinery, or do anything that needs alertness until you can do||
1981|137|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
1981|138|P|are using marijuana (cannabis). Alcohol may also increase the||
1981|139|P|drug levels.||
1981|140|P|   Older adults may be more sensitive to the effects of the drug,||
1981|141|P|especially drowsiness. This drug may also cause excitement||
1981|142|P|instead of drowsiness in older adults.||
1981|143|P|   Children may be more sensitive to the effects of the drug.||
1981|144|P|This drug can often cause excitement in young children instead of||
1981|145|P|drowsiness.||
1981|146|P|   During pregnancy, this medication should be used only when||
1981|147|P|clearly needed. It may harm an unborn baby. Newborn babies of||
1981|148|P|mothers who use this medication late in pregnancy may have||
1981|149|P|symptoms such as slow/shallow breathing, nonstop crying, shaking,||
1981|150|P|or trouble feeding. However, since untreated seizures are a||
1981|151|P|serious condition that can harm both a pregnant woman and her||
1981|152|P|unborn baby, do not stop taking this medication unless directed||
1981|153|P|by your doctor. If you are planning pregnancy, become pregnant,||
1981|154|P|or think you may be pregnant, talk to your doctor right away||
1981|155|P|about the risks and benefits of this medication. Since birth||
1981|156|P|control pills, patches, implants, and injections may not work if||
1981|157|P|taken with this medication (see also Drug Interactions section),||
1981|158|P|discuss reliable forms of birth control with your doctor.||
1981|159|P|   This drug passes into breast milk and may have undesirable||
1981|160|P|effects on a nursing infant. Consult your doctor before||
1981|161|P|breastfeeding.||
1981|162|B|||
1981|163|I|DRUG INTERACTIONS:  See also Warning section.||
1981|164|I|   Drug interactions may change how your medications work or||
1981|165|I|increase your risk for serious side effects. This document does||
1981|166|I|not contain all possible drug interactions. Keep a list of all||
1981|167|I|the products you use (including prescription/nonprescription||
1981|168|I|drugs and herbal products) and share it with your doctor and||
1981|169|I|pharmacist. Do not start, stop, or change the dosage of any||
1981|170|I|medicines without your doctor's approval.||
1981|171|I|   Some products that may interact with this drug are: orlistat,||
1981|172|I|sodium oxybate.||
1981|173|I|   Other medications can affect the removal of clobazam from your||
1981|174|I|body, which may affect how clobazam works. Examples include||
1981|175|I|fluconazole, fluvoxamine, among others.||
1981|176|I|   The risk of serious side effects (such as slow/shallow||
1981|177|I|breathing, severe drowsiness/dizziness) may be increased if this||
1981|178|I|medication is taken with other products that may also cause||
1981|179|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
1981|180|I|if you are taking other products such as opioid pain or cough||
1981|181|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
1981|182|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
1981|183|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
1981|184|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
1981|185|I|diphenhydramine).||
1981|186|I|   Check the labels on all your medicines (such as allergy or||
1981|187|I|cough-and-cold products) because they may contain ingredients||
1981|188|I|that cause drowsiness. Ask your pharmacist about using those||
1981|189|I|products safely.||
1981|190|I|   This medication may decrease the effectiveness of hormonal||
1981|191|I|birth control such as pills, patch, or ring. This could cause||
1981|192|I|pregnancy. Discuss with your doctor or pharmacist if you should||
1981|193|I|use reliable backup birth control methods while using this||
1981|194|I|medication. Also tell your doctor if you have any new spotting or||
1981|195|I|breakthrough bleeding, because these may be signs that your birth||
1981|196|I|control is not working well.||
1981|197|B|||
1981|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1981|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1981|200|O|poison control center right away. US residents can call||
1981|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1981|202|O|Symptoms of overdose may include: confusion, weakness, severe||
1981|203|O|drowsiness/dizziness, slow/shallow breathing, loss of||
1981|204|O|consciousness, slowed/decreased reflexes.||
1981|205|B|||
1981|206|N|NOTES:  Do not share this medication with others. Sharing it is||
1981|207|N|against the law.||
1981|208|B|||
1981|209|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1981|210|D|remember. If it is near the time of the next dose, skip the||
1981|211|D|missed dose. Take your next dose at the regular time. Do not||
1981|212|D|double the dose to catch up.||
1981|213|B|||
1981|214|R|STORAGE:  Store at room temperature away from light and moisture.||
1981|215|R|Do not store in the bathroom. Keep all medications away from||
1981|216|R|children and pets.||
1981|217|R|   Do not flush medications down the toilet or pour them into a||
1981|218|R|drain unless instructed to do so. Properly discard this product||
1981|219|R|when it is expired or no longer needed. Consult your pharmacist||
1981|220|R|or local waste disposal company.||
1981|221|B|||
1981|222|M|MEDICAL ALERT:  Your condition can cause complications in a||
1981|223|M|medical emergency. For information about enrolling in MedicAlert,||
1981|224|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1981|225|B|||
1981|226|A|Information last revised May 2024.||
1981|227|A|Copyright(c) 2025 First Databank, Inc.||
1981|228|B|||
1982|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1982|002|Z|does NOT have all possible information about this product. This||
1982|003|Z|information does not assure that this product is safe, effective,||
1982|004|Z|or appropriate for you. This information is not individual||
1982|005|Z|medical advice and does not substitute for the advice of your||
1982|006|Z|health care professional. Always ask your health care||
1982|007|Z|professional for complete information about this product and your||
1982|008|Z|specific health needs.||
1982|009|B|||
1982|010|T|GLASDEGIB - ORAL||
1982|011|F|(glas-DEG-ib)||
1982|012|B|||
1982|013|C|COMMON BRAND NAME(S): Daurismo||
1982|014|B|||
1982|015|W|WARNING:  Glasdegib is not recommended for use during pregnancy||
1982|016|W|because it may cause serious harm (possibly death) to an unborn||
1982|017|W|baby. Women of childbearing age must have a pregnancy test within||
1982|018|W|7 days before starting this medication. They should also use||
1982|019|W|reliable forms of birth control while taking glasdegib and for at||
1982|020|W|least 30 days after the last dose.||
1982|021|W|   It is unknown if glasdegib passes into semen. Because of the||
1982|022|W|possible risk of passing the drug to a partner, men (including||
1982|023|W|men who have had a vasectomy) must use condoms during sex with||
1982|024|W|women who are pregnant or of childbearing age, both during||
1982|025|W|treatment with glasdegib and for at least 30 days after the last||
1982|026|W|dose. Men should also not donate sperm during this time.||
1982|027|W|   If you or your partner become pregnant or think you may be||
1982|028|W|pregnant, tell your doctor right away.||
1982|029|B|||
1982|030|U|USES:  This medication is used to treat a certain type of cancer||
1982|031|U|(acute myeloid leukemia-AML). It works by slowing or stopping the||
1982|032|U|growth of cancer cells.||
1982|033|B|||
1982|034|H|HOW TO USE:  Read the Medication Guide provided by your||
1982|035|H|pharmacist before you start taking glasdegib and each time you||
1982|036|H|get a refill. If you have any questions, ask your doctor or||
1982|037|H|pharmacist.||
1982|038|H|   Take this medication by mouth with or without food as directed||
1982|039|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
1982|040|H|not break, crush, or chew the tablets. The dosage is based on||
1982|041|H|your medical condition and response to treatment.||
1982|042|H|   If you vomit after taking a dose, do not take another dose at||
1982|043|H|that time. Take your next dose at the regular time.||
1982|044|H|   Do not increase your dose or use this drug more often or for||
1982|045|H|longer than prescribed. Your condition will not improve any||
1982|046|H|faster, and your risk of side effects will increase.||
1982|047|H|   Take this medication regularly to get the most benefit from||
1982|048|H|it. To help you remember, take it at the same time each day.||
1982|049|H|   Since this drug can be absorbed through the skin and lungs,||
1982|050|H|women who are pregnant or who may become pregnant should not||
1982|051|H|handle this medication or breathe the dust from the tablets.||
1982|052|B|||
1982|053|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, constipation,||
1982|054|S|abdominal pain, dizziness, headache, change in how food||
1982|055|S|tastes/loss of ability to taste, loss of appetite, weight loss,||
1982|056|S|joint pain, or tiredness may occur. If any of these effects last||
1982|057|S|or get worse, tell your doctor or pharmacist promptly.||
1982|058|S|   Pain or sores in the mouth and throat may occur. Brush your||
1982|059|S|teeth carefully/gently, avoid using mouthwash that contains||
1982|060|S|alcohol, and rinse your mouth often with cool water mixed with||
1982|061|S|baking soda or salt. It may also be best to eat soft, moist||
1982|062|S|foods.||
1982|063|S|   Temporary hair loss may occur. Normal hair growth should||
1982|064|S|return after treatment has ended.||
1982|065|S|   People using this medication may have serious side effects.||
1982|066|S|However, you have been prescribed this drug because your doctor||
1982|067|S|has judged that the benefit to you is greater than the risk of||
1982|068|S|side effects. Careful monitoring by your doctor may decrease your||
1982|069|S|risk.||
1982|070|S|   Tell your doctor right away if you have any serious side||
1982|071|S|effects, including: easy bruising/bleeding, chest pain, signs of||
1982|072|S|kidney problems (such as change in the amount of urine), swelling||
1982|073|S|hands/ankles/feet, muscle pain/spasms.||
1982|074|S|   Get medical help right away if you have any very serious side||
1982|075|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1982|076|S|fainting.||
1982|077|S|   This medication may lower your ability to fight infections.||
1982|078|S|This may make you more likely to get a serious (rarely fatal)||
1982|079|S|infection or make any infection you have worse. Tell your doctor||
1982|080|S|right away if you have any signs of infection (such as sore||
1982|081|S|throat that doesn't go away, fever, chills).||
1982|082|S|   Glasdegib can commonly cause a rash that is usually not||
1982|083|S|serious. However, you may not be able to tell it apart from a||
1982|084|S|rare rash that could be a sign of a severe reaction. Tell your||
1982|085|S|doctor right away if you develop any rash.||
1982|086|S|   A very serious allergic reaction to this drug is rare.||
1982|087|S|However, get medical help right away if you notice any symptoms||
1982|088|S|of a serious allergic reaction, including: rash, itching/swelling||
1982|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1982|090|S|breathing.||
1982|091|S|   This is not a complete list of possible side effects. If you||
1982|092|S|notice other effects not listed above, contact your doctor or||
1982|093|S|pharmacist.||
1982|094|S|   In the US -||
1982|095|S|   Call your doctor for medical advice about side effects. You||
1982|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1982|097|S|www.fda.gov/medwatch.||
1982|098|S|   In Canada - Call your doctor for medical advice about side||
1982|099|S|effects. You may report side effects to Health Canada at||
1982|100|S|1-866-234-2345.||
1982|101|B|||
1982|102|P|PRECAUTIONS:  Before taking glasdegib, tell your doctor or||
1982|103|P|pharmacist if you are allergic to it; or if you have any other||
1982|104|P|allergies. This product may contain inactive ingredients, which||
1982|105|P|can cause allergic reactions or other problems. Talk to your||
1982|106|P|pharmacist for more details.||
1982|107|P|   Before using this medication, tell your doctor or pharmacist||
1982|108|P|your medical history, especially of: current/recent infection,||
1982|109|P|kidney problems, liver problems.||
1982|110|P|   Glasdegib can make you more likely to get infections or may||
1982|111|P|make current infections worse. Stay away from anyone who has an||
1982|112|P|infection that may easily spread (such as chickenpox, COVID-19,||
1982|113|P|measles, flu). Talk to your doctor if you have been exposed to an||
1982|114|P|infection or for more details.||
1982|115|P|   Tell your health care professional that you are using||
1982|116|P|glasdegib before having any immunizations/vaccinations. Avoid||
1982|117|P|contact with people who have recently received live vaccines||
1982|118|P|(such as flu vaccine inhaled through the nose).||
1982|119|P|   To lower the chance of getting cut, bruised, or injured, use||
1982|120|P|caution with sharp objects like razors and nail cutters, and||
1982|121|P|avoid activities such as contact sports.||
1982|122|P|   Glasdegib may cause a condition that affects the heart rhythm||
1982|123|P|(QT prolongation). QT prolongation can rarely cause serious||
1982|124|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
1982|125|P|as severe dizziness, fainting) that need medical attention right||
1982|126|P|away.||
1982|127|P|   The risk of QT prolongation may be increased if you have||
1982|128|P|certain medical conditions or are taking other drugs that may||
1982|129|P|cause QT prolongation. Before using glasdegib, tell your doctor||
1982|130|P|or pharmacist of all the drugs you take and if you have any of||
1982|131|P|the following conditions: certain heart problems (heart failure,||
1982|132|P|slow heartbeat, QT prolongation in the EKG), family history of||
1982|133|P|certain heart problems (QT prolongation in the EKG, sudden||
1982|134|P|cardiac death).||
1982|135|P|   Low levels of potassium or magnesium in the blood may also||
1982|136|P|increase your risk of QT prolongation. This risk may increase if||
1982|137|P|you use certain drugs (such as diuretics/"water pills") or if you||
1982|138|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1982|139|P|Talk to your doctor about using glasdegib safely.||
1982|140|P|   Before having surgery, tell your doctor or dentist about all||
1982|141|P|the products you use (including prescription drugs,||
1982|142|P|nonprescription drugs, and herbal products).||
1982|143|P|   Do not donate blood while taking this drug and for at least 30||
1982|144|P|days after stopping treatment. This will prevent your blood from||
1982|145|P|being given to a pregnant woman.||
1982|146|P|   Older adults may be more sensitive to the side effects of this||
1982|147|P|drug, especially QT prolongation (see above).||
1982|148|P|   Since this drug can be absorbed through the skin and lungs and||
1982|149|P|may harm an unborn baby, women who are pregnant or who may become||
1982|150|P|pregnant should not handle this medication or breathe the dust||
1982|151|P|from the tablets.||
1982|152|P|   This medication is not recommended for use during pregnancy.||
1982|153|P|It may harm an unborn baby. Discuss the use of reliable forms of||
1982|154|P|birth control (such as condoms, birth control pills) with your||
1982|155|P|doctor. Consult your doctor for more details. (See also Warning||
1982|156|P|section.)||
1982|157|P|   It is unknown if this medication passes into breast milk.||
1982|158|P|Because of the possible risk to the infant, breastfeeding is not||
1982|159|P|recommended while using this medication and for at least 30 days||
1982|160|P|after the last dose. Consult your doctor before breastfeeding.||
1982|161|B|||
1982|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1982|163|I|medications work or increase your risk for serious side effects.||
1982|164|I|This document does not contain all possible drug interactions.||
1982|165|I|Keep a list of all the products you use (including||
1982|166|I|prescription/nonprescription drugs and herbal products) and share||
1982|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
1982|168|I|the dosage of any medicines without your doctor's approval.||
1982|169|I|   Other medications can affect the removal of glasdegib from||
1982|170|I|your body, which may affect how glasdegib works. Examples include||
1982|171|I|apalutamide, azole antifungals (such as itraconazole,||
1982|172|I|ketoconazole), enzalutamide, nefazodone, rifamycins (such as||
1982|173|I|rifabutin, rifampin), ritonavir, St. John's wort, drugs used to||
1982|174|I|treat seizures (such as carbamazepine, phenytoin), telithromycin,||
1982|175|I|among others.||
1982|176|B|||
1982|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1982|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1982|179|O|poison control center right away. US residents can call||
1982|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1982|181|B|||
1982|182|N|NOTES:  Do not share this medication with others.||
1982|183|N|   Lab and/or medical tests (such as kidney/liver function,||
1982|184|N|complete blood count, EKG, CPK levels) should be done before you||
1982|185|N|start taking this medication and while you are taking it. Keep||
1982|186|N|all medical and lab appointments.||
1982|187|B|||
1982|188|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1982|189|D|remember. If it is less than 12 hours before the next dose, skip||
1982|190|D|the missed dose. Take your next dose at the regular time. Do not||
1982|191|D|double the dose to catch up.||
1982|192|B|||
1982|193|R|STORAGE:  Store at room temperature away from light and moisture.||
1982|194|R|Do not store in the bathroom. Keep all medications away from||
1982|195|R|children and pets.||
1982|196|R|   Do not flush medications down the toilet or pour them into a||
1982|197|R|drain unless instructed to do so. Properly discard this product||
1982|198|R|when it is expired or no longer needed. Consult your pharmacist||
1982|199|R|or local waste disposal company.||
1982|200|B|||
1982|201|M|MEDICAL ALERT:  Your condition can cause complications in a||
1982|202|M|medical emergency. For information about enrolling in MedicAlert,||
1982|203|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1982|204|B|||
1982|205|A|Information last revised April 2025.||
1982|206|A|Copyright(c) 2025 First Databank, Inc.||
1982|207|B|||
1983|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1983|002|Z|does NOT have all possible information about this product. This||
1983|003|Z|information does not assure that this product is safe, effective,||
1983|004|Z|or appropriate for you. This information is not individual||
1983|005|Z|medical advice and does not substitute for the advice of your||
1983|006|Z|health care professional. Always ask your health care||
1983|007|Z|professional for complete information about this product and your||
1983|008|Z|specific health needs.||
1983|009|B|||
1983|010|T|GILTERITINIB - ORAL||
1983|011|F|(GIL-te-RI-ti-nib)||
1983|012|B|||
1983|013|C|COMMON BRAND NAME(S): Xospata||
1983|014|B|||
1983|015|W|WARNING:  Gilteritinib has rarely caused a serious (possibly||
1983|016|W|fatal) condition called differentiation syndrome. Get medical||
1983|017|W|help right away if you develop any signs of differentiation||
1983|018|W|syndrome, such as fever, cough, shortness of breath, trouble||
1983|019|W|breathing, rapid weight gain, swelling of arms/legs, signs of||
1983|020|W|kidney problems (such as change in the amount of urine), or||
1983|021|W|dizziness/lightheadedness.||
1983|022|B|||
1983|023|U|USES:  Gilteritinib is used to treat acute myeloid leukemia||
1983|024|U|(AML). It works by slowing or stopping the growth of cancer||
1983|025|U|cells.||
1983|026|B|||
1983|027|H|HOW TO USE:  Read the Medication Guide provided by your||
1983|028|H|pharmacist before you start taking gilteritinib and each time you||
1983|029|H|get a refill. If you have any questions, ask your doctor or||
1983|030|H|pharmacist.||
1983|031|H|   Take this medication by mouth with or without food as directed||
1983|032|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
1983|033|H|not crush, chew, or split the tablets.||
1983|034|H|   The dosage is based on your medical condition and response to||
1983|035|H|treatment.||
1983|036|H|   Do not increase your dose or take this drug more often or for||
1983|037|H|longer than prescribed. Your condition will not improve any||
1983|038|H|faster, and your risk of serious side effects will increase.||
1983|039|H|   Use this medication regularly to get the most benefit from it.||
1983|040|H|To help you remember, take it at the same time each day.||
1983|041|B|||
1983|042|S|SIDE EFFECTS:  See also Warning section.||
1983|043|S|   Tiredness, constipation, nausea/vomiting, diarrhea, mouth||
1983|044|S|sores, decreased appetite, changes in taste, headache, trouble||
1983|045|S|sleeping, or muscle/joint pain may occur. If any of these effects||
1983|046|S|last or get worse, tell your doctor or pharmacist promptly.||
1983|047|S|   Remember that this medication has been prescribed because your||
1983|048|S|doctor has judged that the benefit to you is greater than the||
1983|049|S|risk of side effects. Many people using this medication do not||
1983|050|S|have serious side effects.||
1983|051|S|   This medication may raise your blood pressure. Check your||
1983|052|S|blood pressure regularly and tell your doctor if the results are||
1983|053|S|high.||
1983|054|S|   Tell your doctor right away if you have any serious side||
1983|055|S|effects, including: nausea/vomiting that doesn't stop,||
1983|056|S|stomach/abdominal pain, vision changes (such as blurred vision,||
1983|057|S|decreased vision), mental/mood changes (such as confusion).||
1983|058|S|   Get medical help right away if you have any very serious side||
1983|059|S|effects, including: fast/irregular heartbeat, severe dizziness,||
1983|060|S|fainting, seizures.||
1983|061|S|   A very serious allergic reaction to this drug is rare.||
1983|062|S|However, get medical help right away if you notice any symptoms||
1983|063|S|of a serious allergic reaction, including: rash, itching/swelling||
1983|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1983|065|S|breathing.||
1983|066|S|   This is not a complete list of possible side effects. If you||
1983|067|S|notice other effects not listed above, contact your doctor or||
1983|068|S|pharmacist.||
1983|069|S|   In the US -||
1983|070|S|   Call your doctor for medical advice about side effects. You||
1983|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1983|072|S|www.fda.gov/medwatch.||
1983|073|S|   In Canada - Call your doctor for medical advice about side||
1983|074|S|effects. You may report side effects to Health Canada at||
1983|075|S|1-866-234-2345.||
1983|076|B|||
1983|077|P|PRECAUTIONS:  Before taking gilteritinib, tell your doctor or||
1983|078|P|pharmacist if you are allergic to it or if you have any other||
1983|079|P|allergies. This product may contain inactive ingredients, which||
1983|080|P|can cause allergic reactions or other problems. Talk to your||
1983|081|P|pharmacist for more details.||
1983|082|P|   Before using this medication, tell your doctor or pharmacist||
1983|083|P|your medical history.||
1983|084|P|   Gilteritinib may cause a condition that affects the heart||
1983|085|P|rhythm (QT prolongation). QT prolongation can rarely cause||
1983|086|P|serious (rarely fatal) fast/irregular heartbeat and other||
1983|087|P|symptoms (such as severe dizziness, fainting) that need medical||
1983|088|P|attention right away.||
1983|089|P|   The risk of QT prolongation may be increased if you have||
1983|090|P|certain medical conditions or are taking other drugs that may||
1983|091|P|cause QT prolongation. Before using gilteritinib, tell your||
1983|092|P|doctor or pharmacist of all the drugs you take and if you have||
1983|093|P|any of the following conditions: certain heart problems (heart||
1983|094|P|failure, slow heartbeat, QT prolongation in the EKG), family||
1983|095|P|history of certain heart problems (QT prolongation in the EKG,||
1983|096|P|sudden cardiac death).||
1983|097|P|   Low levels of potassium or magnesium in the blood may also||
1983|098|P|increase your risk of QT prolongation. This risk may increase if||
1983|099|P|you use certain drugs (such as diuretics/"water pills") or if you||
1983|100|P|have conditions such as severe sweating, diarrhea, or vomiting.||
1983|101|P|Talk to your doctor about using gilteritinib safely.||
1983|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1983|103|P|can make you more dizzy. Do not drive, use machinery, or do||
1983|104|P|anything that needs alertness until you can do it safely. Limit||
1983|105|P|alcoholic beverages. Talk to your doctor if you are using||
1983|106|P|marijuana (cannabis).||
1983|107|P|   Before having surgery, tell your doctor or dentist about all||
1983|108|P|the products you use (including prescription drugs,||
1983|109|P|nonprescription drugs, and herbal products).||
1983|110|P|   Older adults may be more sensitive to the side effects of this||
1983|111|P|drug, especially QT prolongation (see above).||
1983|112|P|   Tell your doctor if you are pregnant or plan to become||
1983|113|P|pregnant. You should not become pregnant while using||
1983|114|P|gilteritinib. Gilteritinib may harm an unborn baby. Women using||
1983|115|P|this medication should ask about reliable forms of birth control||
1983|116|P|during treatment and for 6 months after the last dose. Men using||
1983|117|P|this medication should ask about reliable forms of birth control||
1983|118|P|during treatment and for 4 months after the last dose. If you or||
1983|119|P|your partner becomes pregnant, talk to your doctor right away||
1983|120|P|about the risks and benefits of this medication.||
1983|121|P|   It is unknown if this medication passes into breast milk.||
1983|122|P|Because of the possible risk to the infant, breastfeeding is not||
1983|123|P|recommended while using this medication and for 2 months after||
1983|124|P|the last dose. Consult your doctor before breastfeeding.||
1983|125|B|||
1983|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1983|127|I|medications work or increase your risk for serious side effects.||
1983|128|I|This document does not contain all possible drug interactions.||
1983|129|I|Keep a list of all the products you use (including||
1983|130|I|prescription/nonprescription drugs and herbal products) and share||
1983|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
1983|132|I|the dosage of any medicines without your doctor's approval.||
1983|133|I|   Other medications can affect the removal of gilteritinib from||
1983|134|I|your body, which may affect how gilteritinib works. Examples||
1983|135|I|include itraconazole, rifamycins (such as rifampin), among||
1983|136|I|others.||
1983|137|B|||
1983|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1983|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1983|140|O|poison control center right away. US residents can call||
1983|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1983|142|B|||
1983|143|N|NOTES:  Do not share this medication with others.||
1983|144|N|   Lab and/or medical tests (such as kidney/liver function, blood||
1983|145|N|mineral levels) should be done while you are taking this||
1983|146|N|medication. Keep all medical and lab appointments.||
1983|147|B|||
1983|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1983|149|D|remember. If it is within 12 hours of the next dose, skip the||
1983|150|D|missed dose. Take your next dose at the regular time. Do not||
1983|151|D|double the dose to catch up.||
1983|152|B|||
1983|153|R|STORAGE:  Keep this medication in the container provided by your||
1983|154|R|pharmacist at room temperature away from light and moisture. Do||
1983|155|R|not store in a different container, such as a pill box. Do not||
1983|156|R|store in the bathroom. Keep all medications away from children||
1983|157|R|and pets.||
1983|158|R|   Do not flush medications down the toilet or pour them into a||
1983|159|R|drain unless instructed to do so. Properly discard this product||
1983|160|R|when it is expired or no longer needed. Consult your pharmacist||
1983|161|R|or local waste disposal company.||
1983|162|B|||
1983|163|A|Information last revised May 2024.||
1983|164|A|Copyright(c) 2025 First Databank, Inc.||
1983|165|B|||
1984|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1984|002|Z|does NOT have all possible information about this product. This||
1984|003|Z|information does not assure that this product is safe, effective,||
1984|004|Z|or appropriate for you. This information is not individual||
1984|005|Z|medical advice and does not substitute for the advice of your||
1984|006|Z|health care professional. Always ask your health care||
1984|007|Z|professional for complete information about this product and your||
1984|008|Z|specific health needs.||
1984|009|B|||
1984|010|T|LAROTRECTINIB - ORAL||
1984|011|F|(LAR-oh-TREK-ti-nib)||
1984|012|B|||
1984|013|C|COMMON BRAND NAME(S): Vitrakvi||
1984|014|B|||
1984|015|U|USES:  Larotrectinib is used to treat cancer. It works by slowing||
1984|016|U|or stopping the growth of cancer cells.||
1984|017|B|||
1984|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1984|019|H|from your pharmacist before you start taking larotrectinib and||
1984|020|H|each time you get a refill. If you have any questions, ask your||
1984|021|H|doctor or pharmacist.||
1984|022|H|   Take this medication by mouth with or without food as directed||
1984|023|H|by your doctor, usually twice daily. Swallow the capsules whole||
1984|024|H|with water. Do not crush or chew the capsules.||
1984|025|H|   If you are using the liquid form of this medication, carefully||
1984|026|H|measure the dose using a special measuring device/spoon. Do not||
1984|027|H|use a household spoon because you may not get the correct dose.||
1984|028|H|   The dosage is based on your body size, medical condition,||
1984|029|H|response to treatment, and other medications you may be taking.||
1984|030|H|Be sure to tell your doctor and pharmacist about all the products||
1984|031|H|you use (including prescription drugs, nonprescription drugs, and||
1984|032|H|herbal products).||
1984|033|H|   Use this medication regularly to get the most benefit from it.||
1984|034|H|To help you remember, take it at the same time(s) each day.||
1984|035|H|   Do not increase your dose or take this drug more often or for||
1984|036|H|longer than prescribed. Your condition will not improve any||
1984|037|H|faster, and your risk of serious side effects will increase.||
1984|038|H|   Avoid eating grapefruit or drinking grapefruit juice while||
1984|039|H|using this medication unless your doctor or pharmacist says you||
1984|040|H|may do so safely. Grapefruit can increase the chance of side||
1984|041|H|effects with this medicine. Ask your doctor or pharmacist for||
1984|042|H|more details.||
1984|043|H|   If you vomit after taking a dose, do not take an extra dose.||
1984|044|H|Take your next dose at the regular time.||
1984|045|B|||
1984|046|S|SIDE EFFECTS:  Tiredness, dizziness, cough, constipation,||
1984|047|S|swelling ankles/feet/hands, nausea, or vomiting may occur. Nausea||
1984|048|S|and vomiting can be severe. In some cases, your doctor may||
1984|049|S|prescribe medication to prevent or relieve nausea and vomiting.||
1984|050|S|Eating several small meals, not eating before treatment, or||
1984|051|S|limiting activity may help lessen some of these effects. If any||
1984|052|S|of these effects last or get worse, tell your doctor or||
1984|053|S|pharmacist promptly.||
1984|054|S|   Remember that this medication has been prescribed because your||
1984|055|S|doctor has judged that the benefit to you is greater than the||
1984|056|S|risk of side effects. Many people using this medication do not||
1984|057|S|have serious side effects.||
1984|058|S|   Tell your doctor right away if you have any serious side||
1984|059|S|effects, including: signs of liver problems (such as||
1984|060|S|nausea/vomiting that doesn't stop, loss of appetite,||
1984|061|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
1984|062|S|numbness/tingling of arms/legs, mental/mood changes (such as||
1984|063|S|confusion, depression, anxiety, memory loss), trouble sleeping,||
1984|064|S|trouble speaking, difficult/unsteady walking, bone pain, easily||
1984|065|S|broken bones.||
1984|066|S|   A very serious allergic reaction to this drug is rare.||
1984|067|S|However, get medical help right away if you notice any symptoms||
1984|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1984|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1984|070|S|breathing.||
1984|071|S|   This is not a complete list of possible side effects. If you||
1984|072|S|notice other effects not listed above, contact your doctor or||
1984|073|S|pharmacist.||
1984|074|S|   In the US -||
1984|075|S|   Call your doctor for medical advice about side effects. You||
1984|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1984|077|S|www.fda.gov/medwatch.||
1984|078|S|   In Canada - Call your doctor for medical advice about side||
1984|079|S|effects. You may report side effects to Health Canada at||
1984|080|S|1-866-234-2345.||
1984|081|B|||
1984|082|P|PRECAUTIONS:  Before taking larotrectinib, tell your doctor or||
1984|083|P|pharmacist if you are allergic to it; or if you have any other||
1984|084|P|allergies. This product may contain inactive ingredients which||
1984|085|P|can cause allergic reactions or other problems. Talk to your||
1984|086|P|pharmacist for more details.||
1984|087|P|   Before using this medication, tell your doctor or pharmacist||
1984|088|P|your medical history, especially of: liver disease.||
1984|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1984|090|P|can make you more dizzy. Do not drive, use machinery, or do||
1984|091|P|anything that needs alertness until you can do it safely. Limit||
1984|092|P|alcoholic beverages. Talk to your doctor if you are using||
1984|093|P|marijuana (cannabis).||
1984|094|P|   Before having surgery, tell your doctor or dentist about all||
1984|095|P|the products you use (including prescription drugs,||
1984|096|P|nonprescription drugs, and herbal products).||
1984|097|P|   Tell your doctor if you are pregnant or plan to become||
1984|098|P|pregnant. You should not become pregnant while using||
1984|099|P|larotrectinib. Larotrectinib may harm an unborn baby. Men and||
1984|100|P|women using this medication should ask about reliable forms of||
1984|101|P|birth control during treatment and for 1 week after the last||
1984|102|P|dose. If you or your partner becomes pregnant, talk to your||
1984|103|P|doctor right away about the risks and benefits of this||
1984|104|P|medication.||
1984|105|P|   It is unknown if this medication passes into breast milk.||
1984|106|P|Because of the possible risk to the infant, breastfeeding is not||
1984|107|P|recommended while using this medication and for 1 week after the||
1984|108|P|last dose. Consult your doctor before breastfeeding.||
1984|109|B|||
1984|110|I|DRUG INTERACTIONS:  See also How to Use section.||
1984|111|I|   Drug interactions may change how your medications work or||
1984|112|I|increase your risk for serious side effects. This document does||
1984|113|I|not contain all possible drug interactions. Keep a list of all||
1984|114|I|the products you use (including prescription/nonprescription||
1984|115|I|drugs and herbal products) and share it with your doctor and||
1984|116|I|pharmacist. Do not start, stop, or change the dosage of any||
1984|117|I|medicines without your doctor's approval.||
1984|118|I|   A product that may interact with this drug is: St John's wort.||
1984|119|B|||
1984|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1984|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1984|122|O|poison control center right away. US residents can call||
1984|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1984|124|B|||
1984|125|N|NOTES:  Do not share this medication with others.||
1984|126|N|   Lab and/or medical tests (such as liver function) should be||
1984|127|N|done before your start taking this medication and while you are||
1984|128|N|taking it. Keep all medical and lab appointments. Consult your||
1984|129|N|doctor for more details.||
1984|130|B|||
1984|131|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1984|132|D|remember. If it is within 6 hours of the next dose, skip the||
1984|133|D|missed dose. Take your next dose at the regular time. Do not||
1984|134|D|double the dose to catch up.||
1984|135|B|||
1984|136|R|STORAGE:  Store the capsules at room temperature away from light||
1984|137|R|and moisture. Do not store in the bathroom. Store the liquid form||
1984|138|R|of this medication in the refrigerator. Do not freeze. Once the||
1984|139|R|liquid bottle is opened, the medication expires after 31 or 90||
1984|140|R|days (depending on your product). Keep all medications away from||
1984|141|R|children and pets.||
1984|142|R|   Do not flush medications down the toilet or pour them into a||
1984|143|R|drain unless instructed to do so. Properly discard this product||
1984|144|R|when it is expired or no longer needed. Consult your pharmacist||
1984|145|R|or local waste disposal company.||
1984|146|B|||
1984|147|A|Information last revised September 2024.||
1984|148|A|Copyright(c) 2025 First Databank, Inc.||
1984|149|B|||
1986|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1986|002|Z|does NOT have all possible information about this product. This||
1986|003|Z|information does not assure that this product is safe, effective,||
1986|004|Z|or appropriate for you. This information is not individual||
1986|005|Z|medical advice and does not substitute for the advice of your||
1986|006|Z|health care professional. Always ask your health care||
1986|007|Z|professional for complete information about this product and your||
1986|008|Z|specific health needs.||
1986|009|B|||
1986|010|T|CENEGERMIN - OPHTHALMIC||
1986|011|F|(sen-EH-jer-men)||
1986|012|B|||
1986|013|C|COMMON BRAND NAME(S): Oxervate||
1986|014|B|||
1986|015|U|USES:  This medication is used to treat a certain eye disorder||
1986|016|U|(neurotrophic keratitis) that causes a loss of nerve function to||
1986|017|U|a certain part of your eye (the cornea). Cenegermin is a man-made||
1986|018|U|form of a substance made by your body. It is used by your body to||
1986|019|U|help maintain and make more nerve cells in your eyes. This||
1986|020|U|medication may help prevent decreased vision or loss of vision||
1986|021|U|caused by neurotrophic keratitis.||
1986|022|B|||
1986|023|H|HOW TO USE:  Read the Patient Information Leaflet and||
1986|024|H|Instructions for Use if available from your pharmacist before you||
1986|025|H|start using this medication and each time you get a refill. If||
1986|026|H|you have any questions, ask your doctor or pharmacist.||
1986|027|H|   This medication is stored in a freezer at the pharmacy. If you||
1986|028|H|start treatment right away after receiving the weekly carton, you||
1986|029|H|will have to wait until the first vial is thawed, which could||
1986|030|H|take up to 30 minutes at room temperature. Do not heat this||
1986|031|H|medication any other way, such as by heating in the microwave or||
1986|032|H|placing in hot water.||
1986|033|H|   Use this medication in the affected eye(s) as directed by your||
1986|034|H|doctor, usually 6 times a day, about 2 hours apart starting in||
1986|035|H|the morning.||
1986|036|H|   To apply eye drops, wash hands first. To avoid contamination,||
1986|037|H|do not touch the dropper tip or let it touch your eye or any||
1986|038|H|other surface.||
1986|039|H|   Take a vial out of the refrigerator and follow the||
1986|040|H|manufacturer's directions to prepare and use this medication. If||
1986|041|H|you are directed to use this medication in both eyes, you will||
1986|042|H|need to use 2 vials each day. After you open a vial for use,||
1986|043|H|connect the vial adapter as directed. The opened vial can be put||
1986|044|H|back in the refrigerator for up to 12 hours. If needed, the||
1986|045|H|opened vial may also be stored at room temperature for up to 12||
1986|046|H|hours. Do not freeze or shake the vial. Carefully follow the||
1986|047|H|directions to use the single-use pipette dropper with the vial.||
1986|048|H|   If you are wearing contact lenses, remove them before using||
1986|049|H|eye drops. Wait at least 15 minutes before replacing your contact||
1986|050|H|lenses. Tilt your head back, look upward, and pull down the lower||
1986|051|H|eyelid to make a pouch. Hold the dropper directly over your eye||
1986|052|H|and place one drop into the pouch. With your head tilted back,||
1986|053|H|blink a few times so that the medicine covers the surface of your||
1986|054|H|eye. Look downward, gently close your eyes, and place one finger||
1986|055|H|at the corner of your eye (near the nose). Apply gentle pressure||
1986|056|H|for 1 to 2 minutes before opening your eyes. This will prevent||
1986|057|H|the medication from draining out. Try not to rub your eye. If||
1986|058|H|directed to use this medication in both eyes, repeat these steps||
1986|059|H|for your other eye. Only use 1 pipette dropper for each eye and||
1986|060|H|each dose. Throw away the used pipette dropper right away after||
1986|061|H|use. If you miss your eye and there is no longer any eye drop||
1986|062|H|solution in the dropper, try again, using a new pipette dropper.||
1986|063|H|   Throw away the used vial at the end of each day (after 12||
1986|064|H|hours) even if there is still some eye drop solution left in it.||
1986|065|H|   If you are using another kind of eye medication (such as drops||
1986|066|H|or ointments), wait at least 15 minutes before applying other||
1986|067|H|medications. Use eye drops before eye ointments to allow the||
1986|068|H|drops to enter the eye.||
1986|069|H|   Wait several minutes for your vision to clear before driving||
1986|070|H|or operating machinery.||
1986|071|H|   Use this medication regularly to get the most benefit from it.||
1986|072|H|To help you remember, you may want to set an alarm as a reminder||
1986|073|H|for dosing. Mark the provided weekly dose recording card to track||
1986|074|H|each time you use a dose. Continue to use this medication for the||
1986|075|H|full time prescribed (usually 8 weeks).||
1986|076|H|   Tell your doctor if your condition does not get better or if||
1986|077|H|it gets worse.||
1986|078|B|||
1986|079|S|SIDE EFFECTS:  Eye discomfort/pain/redness, watery eyes, eye||
1986|080|S|sensitivity to light, feeling as if something is in the eye,||
1986|081|S|headache, or temporary blurred vision may occur. If any of these||
1986|082|S|effects last or get worse, tell your doctor or pharmacist||
1986|083|S|promptly.||
1986|084|S|   Remember that this medication has been prescribed because your||
1986|085|S|doctor has judged that the benefit to you is greater than the||
1986|086|S|risk of side effects. Many people using this medication do not||
1986|087|S|have serious side effects.||
1986|088|S|   A very serious allergic reaction to this drug is rare.||
1986|089|S|However, get medical help right away if you notice any symptoms||
1986|090|S|of a serious allergic reaction, including: rash, itching/swelling||
1986|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1986|092|S|breathing.||
1986|093|S|   This is not a complete list of possible side effects. If you||
1986|094|S|notice other effects not listed above, contact your doctor or||
1986|095|S|pharmacist.||
1986|096|S|   In the US -||
1986|097|S|   Call your doctor for medical advice about side effects. You||
1986|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1986|099|S|www.fda.gov/medwatch.||
1986|100|S|   In Canada - Call your doctor for medical advice about side||
1986|101|S|effects. You may report side effects to Health Canada at||
1986|102|S|1-866-234-2345.||
1986|103|B|||
1986|104|P|PRECAUTIONS:  Before using cenegermin, tell your doctor or||
1986|105|P|pharmacist if you are allergic to it; or if you have any other||
1986|106|P|allergies. This product may contain inactive ingredients, which||
1986|107|P|can cause allergic reactions or other problems. Talk to your||
1986|108|P|pharmacist for more details.||
1986|109|P|   Before using this medication, tell your doctor or pharmacist||
1986|110|P|your medical history, especially of: eye infection.||
1986|111|P|   After you apply this drug, your vision may become temporarily||
1986|112|P|blurred. Do not drive, use machinery, or do anything that needs||
1986|113|P|clear vision until you can do it safely.||
1986|114|P|   Before having surgery, tell your doctor or dentist about all||
1986|115|P|the products you use (including prescription drugs,||
1986|116|P|nonprescription drugs, and herbal products).||
1986|117|P|   During pregnancy, this medication should be used only when||
1986|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
1986|119|P|   It is unknown if this drug passes into breast milk. Consult||
1986|120|P|your doctor before breastfeeding.||
1986|121|B|||
1986|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1986|123|I|medications work or increase your risk for serious side effects.||
1986|124|I|This document does not contain all possible drug interactions.||
1986|125|I|Keep a list of all the products you use (including||
1986|126|I|prescription/nonprescription drugs and herbal products) and share||
1986|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
1986|128|I|the dosage of any medicines without your doctor's approval.||
1986|129|B|||
1986|130|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
1986|131|O|has overdosed and has serious symptoms such as passing out or||
1986|132|O|trouble breathing, call 911. Otherwise, call a poison control||
1986|133|O|center right away. US residents can call 1-800-222-1222. Canada||
1986|134|O|residents can call 1-844-764-7669.||
1986|135|B|||
1986|136|N|NOTES:  Do not share this medication with others.||
1986|137|N|   Lab and/or medical tests (such as eye exams) may be done while||
1986|138|N|you are using this medication. Keep all medical and lab||
1986|139|N|appointments. Consult your doctor for more details.||
1986|140|B|||
1986|141|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
1986|142|D|If it is near the time of the next dose, skip the missed dose.||
1986|143|D|Use your next dose at the regular time. Do not double the dose to||
1986|144|D|catch up.||
1986|145|B|||
1986|146|R|STORAGE:  Within 5 hours after leaving the pharmacy, store the||
1986|147|R|weekly carton in the refrigerator away from moisture. Do not||
1986|148|R|freeze or shake. Use/discard within 14 days. Keep all medications||
1986|149|R|away from children and pets.||
1986|150|R|   Do not flush medications down the toilet or pour them into a||
1986|151|R|drain unless instructed to do so. Properly discard this product||
1986|152|R|when it is expired or no longer needed. Consult your pharmacist||
1986|153|R|or local waste disposal company.||
1986|154|B|||
1986|155|A|Information last revised May 2024.||
1986|156|A|Copyright(c) 2025 First Databank, Inc.||
1986|157|B|||
1988|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1988|002|Z|does NOT have all possible information about this product. This||
1988|003|Z|information does not assure that this product is safe, effective,||
1988|004|Z|or appropriate for you. This information is not individual||
1988|005|Z|medical advice and does not substitute for the advice of your||
1988|006|Z|health care professional. Always ask your health care||
1988|007|Z|professional for complete information about this product and your||
1988|008|Z|specific health needs.||
1988|009|B|||
1988|010|T|ELAPEGADEMASE - INJECTION||
1988|011|F|(EL-a-peg-AD-e-mase)||
1988|012|B|||
1988|013|C|COMMON BRAND NAME(S): Revcovi||
1988|014|B|||
1988|015|U|USES:  Elapegademase is used to treat a certain inherited immune||
1988|016|U|system disorder, adenosine deaminase severe combined immune||
1988|017|U|deficiency (ADA-SCID). In this condition, the immune system does||
1988|018|U|not work normally to fight infections. People with this disorder||
1988|019|U|tend to get repeated infections that can be very serious or||
1988|020|U|life-threatening. Elapegademase is a man-made form of a substance||
1988|021|U|made in your body (adenosine deaminase). It helps increase the||
1988|022|U|number of blood cells that prevent and fight infection||
1988|023|U|(lymphocytes).||
1988|024|B|||
1988|025|H|HOW TO USE:  This medication is given by injection into a muscle||
1988|026|H|as directed by your doctor, usually once or twice a week. The||
1988|027|H|dosage is based on your medical condition, weight, lab tests, and||
1988|028|H|response to treatment.||
1988|029|H|   If you are using this medication at home, learn all||
1988|030|H|preparation and usage instructions from your health care||
1988|031|H|professional and the product package. Take the medication out of||
1988|032|H|the refrigerator at least 30 minutes before you inject it to||
1988|033|H|allow it to reach room temperature. Do not warm up this||
1988|034|H|medication any other way (for example, do not heat it in the||
1988|035|H|microwave or place it in hot water). Do not shake the medication.||
1988|036|H|Before using, check this product for particles or discoloration.||
1988|037|H|If either is present, do not use the liquid. Before injecting||
1988|038|H|each dose, clean the skin you are going to inject into (the||
1988|039|H|injection site) with rubbing alcohol. Change the injection site||
1988|040|H|each time to lessen injury under the skin. Learn how to store and||
1988|041|H|discard medical supplies safely.||
1988|042|H|   Use this medication regularly to get the most benefit from it.||
1988|043|H|To help you remember, use it on the same day(s) each week. Mark||
1988|044|H|your calendar with a reminder.||
1988|045|H|   Do not increase your dose or use this drug more often or for||
1988|046|H|longer than prescribed. Your condition will not improve any||
1988|047|H|faster, and your risk of side effects will increase.||
1988|048|H|   Your immune system will improve slowly, usually over 2 to 6||
1988|049|H|months of treatment. Tell your doctor if your condition does not||
1988|050|H|get better or if it gets worse.||
1988|051|B|||
1988|052|S|SIDE EFFECTS:  Bruising/pain at the injection site, cough, or||
1988|053|S|vomiting may occur. If any of these effects last or get worse,||
1988|054|S|tell your doctor or pharmacist promptly.||
1988|055|S|   Remember that this medication has been prescribed because your||
1988|056|S|doctor has judged that the benefit to you is greater than the||
1988|057|S|risk of side effects. Many people using this medication do not||
1988|058|S|have serious side effects.||
1988|059|S|   A very serious allergic reaction to this drug is rare.||
1988|060|S|However, get medical help right away if you notice any symptoms||
1988|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1988|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1988|063|S|breathing.||
1988|064|S|   This is not a complete list of possible side effects. If you||
1988|065|S|notice other effects not listed above, contact your doctor or||
1988|066|S|pharmacist.||
1988|067|S|   In the US -||
1988|068|S|   Call your doctor for medical advice about side effects. You||
1988|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1988|070|S|www.fda.gov/medwatch.||
1988|071|S|   In Canada - Call your doctor for medical advice about side||
1988|072|S|effects. You may report side effects to Health Canada at||
1988|073|S|1-866-234-2345.||
1988|074|B|||
1988|075|P|PRECAUTIONS:  Before using elapegademase, tell your doctor or||
1988|076|P|pharmacist if you are allergic to it; or if you have any other||
1988|077|P|allergies. This product may contain inactive ingredients, which||
1988|078|P|can cause allergic reactions or other problems. Talk to your||
1988|079|P|pharmacist for more details.||
1988|080|P|   Before using this medication, tell your doctor or pharmacist||
1988|081|P|your medical history, especially of: blood clotting problems||
1988|082|P|(such as hemophilia, low blood platelets).||
1988|083|P|   It may take several months before you see an effect from using||
1988|084|P|elapegademase. Even after it starts to work, you may still be at||
1988|085|P|risk for infections. Avoid contact with people who have||
1988|086|P|infections that may spread to others (such as chickenpox,||
1988|087|P|measles, flu). Consult your doctor if you have been exposed to an||
1988|088|P|infection or for more details.||
1988|089|P|   Before having surgery, tell your doctor or dentist about all||
1988|090|P|the products you use (including prescription drugs,||
1988|091|P|nonprescription drugs, and herbal products).||
1988|092|P|   During pregnancy, this medication should be used only when||
1988|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
1988|094|P|   It is unknown if this drug passes into breast milk. Consult||
1988|095|P|your doctor before breastfeeding.||
1988|096|B|||
1988|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1988|098|I|medications work or increase your risk for serious side effects.||
1988|099|I|This document does not contain all possible drug interactions.||
1988|100|I|Keep a list of all the products you use (including||
1988|101|I|prescription/nonprescription drugs and herbal products) and share||
1988|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
1988|103|I|the dosage of any medicines without your doctor's approval.||
1988|104|B|||
1988|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1988|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1988|107|O|poison control center right away. US residents can call||
1988|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1988|109|B|||
1988|110|N|NOTES:  Do not share this medication with others.||
1988|111|N|   Lab and/or medical tests (such as ADA activity, deoxyadenosine||
1988|112|N|nucleotide levels, complete blood counts) must be done before you||
1988|113|N|start taking this medication and while you are taking it. Keep||
1988|114|N|all medical and lab appointments.||
1988|115|B|||
1988|116|D|MISSED DOSE:  It is important to get each dose of this medication||
1988|117|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1988|118|D|right away for a new dosing schedule. Do not double the dose to||
1988|119|D|catch up.||
1988|120|B|||
1988|121|R|STORAGE:  Store in the refrigerator. Do not freeze. Do not use||
1988|122|R|this medication if it has been frozen. Keep the medication in the||
1988|123|R|original carton to protect from light. Discard any unused||
1988|124|R|portion. Keep all medications away from children and pets.||
1988|125|R|   Do not flush medications down the toilet or pour them into a||
1988|126|R|drain unless instructed to do so. Properly discard this product||
1988|127|R|when it is expired or no longer needed. Consult your pharmacist||
1988|128|R|or local waste disposal company.||
1988|129|B|||
1988|130|A|Information last revised October 2024.||
1988|131|A|Copyright(c) 2025 First Databank, Inc.||
1988|132|B|||
1989|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1989|002|Z|does NOT have all possible information about this product. This||
1989|003|Z|information does not assure that this product is safe, effective,||
1989|004|Z|or appropriate for you. This information is not individual||
1989|005|Z|medical advice and does not substitute for the advice of your||
1989|006|Z|health care professional. Always ask your health care||
1989|007|Z|professional for complete information about this product and your||
1989|008|Z|specific health needs.||
1989|009|B|||
1989|010|T|LINCOMYCIN - INJECTION||
1989|011|F|(LIN-koe-MYE-sin)||
1989|012|B|||
1989|013|C|COMMON BRAND NAME(S): Lincocin||
1989|014|B|||
1989|015|W|WARNING:  This medication may rarely cause a severe intestinal||
1989|016|W|condition due to a bacteria called C. difficile. This condition||
1989|017|W|may occur during treatment or weeks to months after treatment has||
1989|018|W|stopped. Tell your doctor right away if you develop: diarrhea||
1989|019|W|that doesn't stop, abdominal or stomach pain/cramping,||
1989|020|W|blood/mucus in your stool. If you have these symptoms, do not use||
1989|021|W|anti-diarrhea or opioid products because they may make symptoms||
1989|022|W|worse.||
1989|023|B|||
1989|024|U|USES:  This medication is used to treat a wide variety of||
1989|025|U|bacterial infections. It works by stopping the growth of||
1989|026|U|bacteria.||
1989|027|B|||
1989|028|H|HOW TO USE:  This medication is given by injection into a vein or||
1989|029|H|muscle as directed by your doctor, usually 1 to 3 times a day.||
1989|030|H|The dosage is based on your medical condition and response to||
1989|031|H|treatment. Children's dosage is also based on weight.||
1989|032|H|   If you are using this medication at home, learn all||
1989|033|H|preparation and usage instructions from your health care||
1989|034|H|professional. Before using, check this product for particles or||
1989|035|H|discoloration. If either is present, do not use the liquid. Learn||
1989|036|H|how to store and discard medical supplies safely.||
1989|037|H|   For the best effect, use this antibiotic at evenly spaced||
1989|038|H|times. To help you remember, use this medication at the same||
1989|039|H|time(s) every day.||
1989|040|H|   Continue to use this medication until the full prescribed||
1989|041|H|amount is finished, even if symptoms disappear after a few days.||
1989|042|H|Stopping the medication too early may result in a return of the||
1989|043|H|infection.||
1989|044|H|   Tell your doctor if your condition lasts or gets worse.||
1989|045|B|||
1989|046|S|SIDE EFFECTS:  See also Warning section.||
1989|047|S|   Nausea, vomiting, diarrhea, or headache may occur. If any of||
1989|048|S|these effects last or get worse, tell your doctor or pharmacist||
1989|049|S|promptly.||
1989|050|S|   Remember that this medication has been prescribed because your||
1989|051|S|doctor has judged that the benefit to you is greater than the||
1989|052|S|risk of side effects. Many people using this medication do not||
1989|053|S|have serious side effects.||
1989|054|S|   Tell your doctor right away if you have any serious side||
1989|055|S|effects, including: pain/swelling at injection site, signs of||
1989|056|S|liver disease (such as nausea/vomiting that doesn't stop,||
1989|057|S|yellowing eyes/skin, dark urine), easy bruising/bleeding, unusual||
1989|058|S|tiredness, fast/slow/irregular heartbeat, dizziness, fainting.||
1989|059|S|   Use of this medication for prolonged or repeated periods may||
1989|060|S|result in oral thrush or a new vaginal yeast infection. Contact||
1989|061|S|your doctor if you notice white patches in your mouth, a change||
1989|062|S|in vaginal discharge, or other new symptoms.||
1989|063|S|   A very serious allergic reaction to this drug is rare.||
1989|064|S|However, get medical help right away if you notice any symptoms||
1989|065|S|of a serious allergic reaction, including: rash, itching/swelling||
1989|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1989|067|S|breathing.||
1989|068|S|   This is not a complete list of possible side effects. If you||
1989|069|S|notice other effects not listed above, contact your doctor or||
1989|070|S|pharmacist.||
1989|071|S|   In the US -||
1989|072|S|   Call your doctor for medical advice about side effects. You||
1989|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1989|074|S|www.fda.gov/medwatch.||
1989|075|S|   In Canada - Call your doctor for medical advice about side||
1989|076|S|effects. You may report side effects to Health Canada at||
1989|077|S|1-866-234-2345.||
1989|078|B|||
1989|079|P|PRECAUTIONS:  Before using lincomycin, tell your doctor or||
1989|080|P|pharmacist if you are allergic to it; or to clindamycin; or if||
1989|081|P|you have any other allergies. This product may contain inactive||
1989|082|P|ingredients (such as benzyl alcohol), which can cause allergic||
1989|083|P|reactions or other problems. Talk to your pharmacist for more||
1989|084|P|details.||
1989|085|P|   Before using this drug, tell your doctor your medical history,||
1989|086|P|especially of: kidney disease, liver disease, stomach/bowel||
1989|087|P|disease (such as colitis).||
1989|088|P|   Lincomycin may cause live bacterial vaccines (such as typhoid||
1989|089|P|vaccine) to not work well. Tell your health care professional||
1989|090|P|that you are using lincomycin before having any||
1989|091|P|immunizations/vaccinations.||
1989|092|P|   Before having surgery, tell your doctor or dentist about all||
1989|093|P|the products you use (including prescription drugs,||
1989|094|P|nonprescription drugs, and herbal products).||
1989|095|P|   Older adults may be more sensitive to the side effects of this||
1989|096|P|drug, especially diarrhea.||
1989|097|P|   During pregnancy, this medication should be used only when||
1989|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
1989|099|P|   This drug passes into breast milk. Consult your doctor before||
1989|100|P|breastfeeding.||
1989|101|B|||
1989|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1989|103|I|medications work or increase your risk for serious side effects.||
1989|104|I|This document does not contain all possible drug interactions.||
1989|105|I|Keep a list of all the products you use (including||
1989|106|I|prescription/nonprescription drugs and herbal products) and share||
1989|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
1989|108|I|the dosage of any medicines without your doctor's approval.||
1989|109|I|   Some products that may interact with this drug are: macrolide||
1989|110|I|antibiotics (such as clarithromycin, erythromycin).||
1989|111|B|||
1989|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1989|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1989|114|O|poison control center right away. US residents can call||
1989|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1989|116|B|||
1989|117|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
1989|118|N|blood counts) may be done while you are using this medication.||
1989|119|N|Keep all medical and lab appointments. Consult your doctor for||
1989|120|N|more details||
1989|121|B|||
1989|122|D|MISSED DOSE:  It is important to get each dose of this medication||
1989|123|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1989|124|D|right away for a new dosing schedule. Do not double the dose to||
1989|125|D|catch up.||
1989|126|B|||
1989|127|R|STORAGE:  Consult the product instructions and your pharmacist||
1989|128|R|for storage details. Keep all medications away from children and||
1989|129|R|pets.||
1989|130|R|   Do not flush medications down the toilet or pour them into a||
1989|131|R|drain unless instructed to do so. Properly discard this product||
1989|132|R|when it is expired or no longer needed. Consult your pharmacist||
1989|133|R|or local waste disposal company.||
1989|134|B|||
1989|135|A|Information last revised December 2024.||
1989|136|A|Copyright(c) 2025 First Databank, Inc.||
1989|137|B|||
1990|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1990|002|Z|does NOT have all possible information about this product. This||
1990|003|Z|information does not assure that this product is safe, effective,||
1990|004|Z|or appropriate for you. This information is not individual||
1990|005|Z|medical advice and does not substitute for the advice of your||
1990|006|Z|health care professional. Always ask your health care||
1990|007|Z|professional for complete information about this product and your||
1990|008|Z|specific health needs.||
1990|009|B|||
1990|010|T|ITRACONAZOLE 65 MILLIGRAM CAPSULE - ORAL||
1990|011|F|(IT-ra-KON-a-zole)||
1990|012|B|||
1990|013|C|COMMON BRAND NAME(S): Tolsura||
1990|014|B|||
1990|015|W|WARNING:  Itraconazole may rarely cause or worsen heart failure.||
1990|016|W|Tell your doctor right away if you develop symptoms of heart||
1990|017|W|failure, such as shortness of breath, swelling ankles/feet,||
1990|018|W|unusual tiredness, or unusual/sudden unexplained weight gain.||
1990|019|W|Consult your doctor for more details.||
1990|020|W|   This medication can slow down the removal of other medications||
1990|021|W|from your body, which may cause very serious (possibly fatal)||
1990|022|W|side effects. Examples of affected drugs include certain "blood||
1990|023|W|thinners" (such as ticagrelor), colchicine, certain drugs to||
1990|024|W|treat irregular heartbeat (such disopyramide, dofetilide,||
1990|025|W|dronedarone, quinidine), eplerenone, ergot alkaloids (such as||
1990|026|W|dihydroergotamine, ergotamine, methylergonovine), felodipine,||
1990|027|W|fesoterodine, irinotecan, ivabradine, lurasidone, methadone,||
1990|028|W|midazolam, nisoldipine, pimozide, ranolazine, certain "statin"||
1990|029|W|cholesterol drugs (such as lovastatin, simvastatin), solifenacin,||
1990|030|W|telithromycin, triazolam, among others. Be sure to tell your||
1990|031|W|doctor and pharmacist about all the products you use (including||
1990|032|W|prescription drugs, nonprescription drugs, and herbal products).||
1990|033|B|||
1990|034|U|USES:  Itraconazole is used to treat a variety of fungal||
1990|035|U|infections. It belongs to a class of drugs known as azole||
1990|036|U|antifungals. It works by stopping the growth of fungi.||
1990|037|B|||
1990|038|V|OTHER USES:  This section contains uses of this drug that are not||
1990|039|V|listed in the approved professional labeling for the drug but||
1990|040|V|that may be prescribed by your health care professional. Use this||
1990|041|V|drug for a condition that is listed in this section only if it||
1990|042|V|has been so prescribed by your health care professional.||
1990|043|V|   This drug may also be used to reduce the risk of certain||
1990|044|V|fungal infections.||
1990|045|B|||
1990|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1990|047|H|from your pharmacist before you start taking itraconazole and||
1990|048|H|each time you get a refill. If you have any questions, ask your||
1990|049|H|doctor or pharmacist.||
1990|050|H|   Take this medication by mouth with food as directed by your||
1990|051|H|doctor, usually once or twice daily. Swallow the capsules whole.||
1990|052|H|Do not chew, crush, or break the capsules.||
1990|053|H|   The dosage and length of treatment are based on your medical||
1990|054|H|condition, response to treatment, and other medications you may||
1990|055|H|be taking. Take this medication exactly as prescribed by your||
1990|056|H|doctor.||
1990|057|H|   For the best effect, take this antifungal at evenly spaced||
1990|058|H|times. To help you remember, take this medication at the same||
1990|059|H|time(s) every day.||
1990|060|H|   Continue to take this medication until the full prescribed||
1990|061|H|amount is finished, even if symptoms disappear after a few days.||
1990|062|H|Stopping the medication too early may result in a return of the||
1990|063|H|infection.||
1990|064|H|   The capsule, tablet, and solution forms of this medication||
1990|065|H|deliver different amounts of medication and may be used for||
1990|066|H|different purposes. Do not switch between the different forms or||
1990|067|H|brands of this drug without your doctor's direction.||
1990|068|H|   Tell your doctor if your condition does not get better or if||
1990|069|H|it gets worse.||
1990|070|B|||
1990|071|S|SIDE EFFECTS:  See also Warning section.||
1990|072|S|   Nausea/vomiting, diarrhea, headache, stomach upset, or||
1990|073|S|dizziness may occur. If any of these effects last or get worse,||
1990|074|S|tell your doctor or pharmacist promptly.||
1990|075|S|   Remember that this medication has been prescribed because your||
1990|076|S|doctor has judged that the benefit to you is greater than the||
1990|077|S|risk of side effects. Many people using this medication do not||
1990|078|S|have serious side effects.||
1990|079|S|   This medication may raise your blood pressure. Check your||
1990|080|S|blood pressure regularly and tell your doctor if the results are||
1990|081|S|high.||
1990|082|S|   Tell your doctor right away if you have any serious side||
1990|083|S|effects, including: numbness/tingling of arms/legs, hearing loss,||
1990|084|S|mental/mood changes (such as depression).||
1990|085|S|   Itraconazole has rarely caused very serious (possibly fatal)||
1990|086|S|liver disease. Tell your doctor right away if you develop||
1990|087|S|symptoms of liver disease, such as: nausea/vomiting that doesn't||
1990|088|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
1990|089|S|eyes/skin, dark urine.||
1990|090|S|   Itraconazole can commonly cause a mild rash that is usually||
1990|091|S|not serious. However, you may not be able to tell it apart from a||
1990|092|S|rare rash that could be a sign of a severe allergic reaction. Get||
1990|093|S|medical help right away if you develop any rash.||
1990|094|S|   A very serious allergic reaction to this drug is rare.||
1990|095|S|However, get medical help right away if you notice any symptoms||
1990|096|S|of a serious allergic reaction, including: rash, itching/swelling||
1990|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1990|098|S|breathing.||
1990|099|S|   This is not a complete list of possible side effects. If you||
1990|100|S|notice other effects not listed above, contact your doctor or||
1990|101|S|pharmacist.||
1990|102|S|   In the US -||
1990|103|S|   Call your doctor for medical advice about side effects. You||
1990|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1990|105|S|www.fda.gov/medwatch.||
1990|106|S|   In Canada - Call your doctor for medical advice about side||
1990|107|S|effects. You may report side effects to Health Canada at||
1990|108|S|1-866-234-2345.||
1990|109|B|||
1990|110|P|PRECAUTIONS:  See also Warning section.||
1990|111|P|   Before taking itraconazole, tell your doctor or pharmacist if||
1990|112|P|you are allergic to it; or to other azole antifungals (such as||
1990|113|P|ketoconazole); or if you have any other allergies. This product||
1990|114|P|may contain inactive ingredients, which can cause allergic||
1990|115|P|reactions or other problems. Talk to your pharmacist for more||
1990|116|P|details.||
1990|117|P|   Before using this medication, tell your doctor or pharmacist||
1990|118|P|your medical history, especially of: liver problems, kidney||
1990|119|P|problems, heart problems (such as heart failure, coronary artery||
1990|120|P|disease, heart valve disease), lung disease (such as chronic||
1990|121|P|obstructive pulmonary disease-COPD).||
1990|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1990|123|P|can make you more dizzy. Do not drive, use machinery, or do||
1990|124|P|anything that needs alertness until you can do it safely. Avoid||
1990|125|P|alcoholic beverages. Talk to your doctor if you are using||
1990|126|P|marijuana (cannabis). Alcohol may also increase the risk of||
1990|127|P|serious liver problems.||
1990|128|P|   Before having surgery, tell your doctor or dentist about all||
1990|129|P|the products you use (including prescription drugs,||
1990|130|P|nonprescription drugs, and herbal products).||
1990|131|P|   Older adults may be at greater risk for hearing loss while||
1990|132|P|using this drug.||
1990|133|P|   During pregnancy, this medication should be used only when||
1990|134|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
1990|135|P|benefits with your doctor. Ask about reliable forms of birth||
1990|136|P|control while taking this medication and for 2 months after||
1990|137|P|stopping treatment.||
1990|138|P|   Itraconazole passes into breast milk. Consult your doctor||
1990|139|P|before breastfeeding.||
1990|140|B|||
1990|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1990|142|I|medications work or increase your risk for serious side effects.||
1990|143|I|This document does not contain all possible drug interactions.||
1990|144|I|Keep a list of all the products you use (including||
1990|145|I|prescription/nonprescription drugs and herbal products) and share||
1990|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
1990|147|I|the dosage of any medicines without your doctor's approval.||
1990|148|I|   Itraconazole interacts with many medications. See also Warning||
1990|149|I|section.||
1990|150|I|   Other medications can affect the removal of itraconazole from||
1990|151|I|your body, which may affect how itraconazole works. Examples||
1990|152|I|include efavirenz, isoniazid, nevirapine, rifamycins (such as||
1990|153|I|rifabutin), certain drugs used to treat seizures (such as||
1990|154|I|phenytoin), among others.||
1990|155|B|||
1990|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1990|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1990|158|O|poison control center right away. US residents can call||
1990|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1990|160|B|||
1990|161|N|NOTES:  Do not share this medication with others.||
1990|162|N|   This medication has been prescribed for your current condition||
1990|163|N|only. Do not use it later for another infection unless your||
1990|164|N|doctor tells you to.||
1990|165|N|   Lab and/or medical tests (such as liver function, potassium||
1990|166|N|level, blood pressure) should be done before you start taking||
1990|167|N|this medication and while you are taking it. Keep all medical and||
1990|168|N|lab appointments. Consult your doctor for more details.||
1990|169|B|||
1990|170|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1990|171|D|remember. If it is near the time of the next dose, skip the||
1990|172|D|missed dose. Take your next dose at the regular time. Do not||
1990|173|D|double the dose to catch up.||
1990|174|B|||
1990|175|R|STORAGE:  Store at room temperature away from light and moisture.||
1990|176|R|Do not store in the bathroom. Keep all medications away from||
1990|177|R|children and pets.||
1990|178|R|   Do not flush medications down the toilet or pour them into a||
1990|179|R|drain unless instructed to do so. Properly discard this product||
1990|180|R|when it is expired or no longer needed. Consult your pharmacist||
1990|181|R|or local waste disposal company.||
1990|182|B|||
1990|183|A|Information last revised October 2024.||
1990|184|A|Copyright(c) 2025 First Databank, Inc.||
1990|185|B|||
1991|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1991|002|Z|does NOT have all possible information about this product. This||
1991|003|Z|information does not assure that this product is safe, effective,||
1991|004|Z|or appropriate for you. This information is not individual||
1991|005|Z|medical advice and does not substitute for the advice of your||
1991|006|Z|health care professional. Always ask your health care||
1991|007|Z|professional for complete information about this product and your||
1991|008|Z|specific health needs.||
1991|009|B|||
1991|010|T|OMADACYCLINE - INJECTION||
1991|011|F|(oh-MAD-a-SYE-kleen)||
1991|012|B|||
1991|013|C|COMMON BRAND NAME(S): Nuzyra||
1991|014|B|||
1991|015|U|USES:  Omadacycline is used to treat a wide variety of bacterial||
1991|016|U|infections. This medication belongs to a class of drugs known as||
1991|017|U|tetracycline antibiotics. It works by stopping the growth of||
1991|018|U|bacteria.||
1991|019|B|||
1991|020|H|HOW TO USE:  This medication is given by slow injection into a||
1991|021|H|vein as directed by your doctor, usually every 12 or every 24||
1991|022|H|hours over 30 to 60 minutes. The dosage is based on your medical||
1991|023|H|condition and response to treatment.||
1991|024|H|   If you are using this medication at home, learn all||
1991|025|H|preparation and usage instructions from your health care||
1991|026|H|professional. Before using, check this product for particles or||
1991|027|H|discoloration. If either is present, do not use the liquid. Learn||
1991|028|H|how to store and discard medical supplies safely.||
1991|029|H|   For the best effect, use this antibiotic at evenly spaced||
1991|030|H|times. To help you remember, use this medication at the same||
1991|031|H|time(s) every day.||
1991|032|H|   Tell your doctor if your condition lasts or gets worse.||
1991|033|B|||
1991|034|S|SIDE EFFECTS:  Pain, redness, and tenderness at the injection||
1991|035|S|site may occur. Nausea, vomiting, or diarrhea may also occur. If||
1991|036|S|any of these effects last or get worse, tell your doctor or||
1991|037|S|pharmacist promptly.||
1991|038|S|   Remember that this medication has been prescribed because your||
1991|039|S|doctor has judged that the benefit to you is greater than the||
1991|040|S|risk of side effects. Many people using this medication do not||
1991|041|S|have serious side effects.||
1991|042|S|   Tell your doctor right away if you have any serious side||
1991|043|S|effects, including: hearing changes (such as ringing in the ears,||
1991|044|S|decreased hearing), signs of kidney problems (such as change in||
1991|045|S|the amount of urine, pink urine), signs of liver problems (such||
1991|046|S|as loss of appetite, stomach/abdominal pain, yellowing eyes/skin,||
1991|047|S|dark urine).||
1991|048|S|   Omadacycline may rarely cause increased pressure around the||
1991|049|S|brain (intracranial hypertension-IH). The risk of this side||
1991|050|S|effect is greater for women of childbearing age who are||
1991|051|S|overweight or who have had IH in the past. If IH develops, it||
1991|052|S|usually goes away after omadacycline is stopped; however, there||
1991|053|S|is a chance of permanent vision loss or blindness. Get medical||
1991|054|S|help right away if you have: severe/lasting headache, vision||
1991|055|S|changes (such as blurred/double vision, decreased vision, sudden||
1991|056|S|blindness), nausea/vomiting that doesn't stop.||
1991|057|S|   This medication may rarely cause a severe intestinal condition||
1991|058|S|due to a bacteria called C. difficile. This condition may occur||
1991|059|S|during treatment or weeks to months after treatment has stopped.||
1991|060|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1991|061|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1991|062|S|stool.||
1991|063|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1991|064|S|products because they may make symptoms worse.||
1991|065|S|   Use of this medication for prolonged or repeated periods may||
1991|066|S|result in oral thrush or a new yeast infection. Contact your||
1991|067|S|doctor if you notice white patches in your mouth, a change in||
1991|068|S|vaginal discharge, or other new symptoms.||
1991|069|S|   A very serious allergic reaction to this drug is rare.||
1991|070|S|However, get medical help right away if you notice any symptoms||
1991|071|S|of a serious allergic reaction, including: fever that doesn't go||
1991|072|S|away, new or worsening lymph node swelling, rash,||
1991|073|S|itching/swelling (especially of the face/tongue/throat), severe||
1991|074|S|dizziness, trouble breathing.||
1991|075|S|   This is not a complete list of possible side effects. If you||
1991|076|S|notice other effects not listed above, contact your doctor or||
1991|077|S|pharmacist.||
1991|078|S|   In the US -||
1991|079|S|   Call your doctor for medical advice about side effects. You||
1991|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1991|081|S|www.fda.gov/medwatch.||
1991|082|S|   In Canada - Call your doctor for medical advice about side||
1991|083|S|effects. You may report side effects to Health Canada at||
1991|084|S|1-866-234-2345.||
1991|085|B|||
1991|086|P|PRECAUTIONS:  Before using omadacycline, tell your doctor or||
1991|087|P|pharmacist if you are allergic to it; or to other tetracyclines||
1991|088|P|(such as doxycycline); or if you have any other allergies. This||
1991|089|P|product may contain inactive ingredients, which can cause||
1991|090|P|allergic reactions or other problems. Talk to your pharmacist for||
1991|091|P|more details.||
1991|092|P|   Before using this medication, tell your doctor or pharmacist||
1991|093|P|your medical history, especially of: kidney problems, liver||
1991|094|P|problems.||
1991|095|P|   This medication may make you more sensitive to the sun. Limit||
1991|096|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1991|097|P|sunscreen and wear protective clothing when outdoors. Tell your||
1991|098|P|doctor right away if you get sunburned or have skin||
1991|099|P|blisters/redness.||
1991|100|P|   Omadacycline may cause live bacterial vaccines (such as||
1991|101|P|typhoid vaccine) to not work well. Tell your health care||
1991|102|P|professional that you are using omadacycline before having any||
1991|103|P|immunizations/vaccinations.||
1991|104|P|   Before having surgery, tell your doctor or dentist about all||
1991|105|P|the products you use (including prescription drugs,||
1991|106|P|nonprescription drugs, and herbal products).||
1991|107|P|   Children younger than 8 years may be more sensitive to the||
1991|108|P|side effects of omadacycline, especially tooth staining. Tooth||
1991|109|P|staining has also happened to older children and young adults.||
1991|110|P|Discuss the risks and benefits of this medication with the||
1991|111|P|doctor.||
1991|112|P|   Tell your doctor if you are pregnant or plan to become||
1991|113|P|pregnant. You should not become pregnant while using||
1991|114|P|omadacycline. Omadacycline may harm an unborn baby. If you become||
1991|115|P|pregnant, talk to your doctor right away about the risks and||
1991|116|P|benefits of this medication.||
1991|117|P|   It is unknown if this medication passes into breast milk.||
1991|118|P|Consult your doctor before breastfeeding.||
1991|119|B|||
1991|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1991|121|I|medications work or increase your risk for serious side effects.||
1991|122|I|This document does not contain all possible drug interactions.||
1991|123|I|Keep a list of all the products you use (including||
1991|124|I|prescription/nonprescription drugs and herbal products) and share||
1991|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
1991|126|I|the dosage of any medicines without your doctor's approval.||
1991|127|I|   Some products that may interact with this drug are: retinoid||
1991|128|I|medications taken by mouth (such as acitretin, isotretinoin).||
1991|129|I|   This medication may interfere with certain lab tests (such as||
1991|130|I|urine catecholamine levels), possibly causing false test results.||
1991|131|I|Make sure lab personnel and all your doctors know you use this||
1991|132|I|drug.||
1991|133|B|||
1991|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1991|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1991|136|O|poison control center right away. US residents can call||
1991|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1991|138|B|||
1991|139|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
1991|140|N|kidney/liver function) may be done while you are using this||
1991|141|N|medication. Keep all medical and lab appointments.||
1991|142|B|||
1991|143|D|MISSED DOSE:  It is important to get each dose of this medication||
1991|144|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1991|145|D|right away for a new dosing schedule. Do not double the dose to||
1991|146|D|catch up.||
1991|147|B|||
1991|148|R|STORAGE:  Consult the product instructions or your pharmacist for||
1991|149|R|storage details. Keep all medications away from children and||
1991|150|R|pets.||
1991|151|R|   Do not flush medications down the toilet or pour them into a||
1991|152|R|drain unless instructed to do so. Properly discard this product||
1991|153|R|when it is expired or no longer needed. Consult your pharmacist||
1991|154|R|or local waste disposal company.||
1991|155|B|||
1991|156|A|Information last revised December 2024.||
1991|157|A|Copyright(c) 2025 First Databank, Inc.||
1991|158|B|||
1992|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1992|002|Z|does NOT have all possible information about this product. This||
1992|003|Z|information does not assure that this product is safe, effective,||
1992|004|Z|or appropriate for you. This information is not individual||
1992|005|Z|medical advice and does not substitute for the advice of your||
1992|006|Z|health care professional. Always ask your health care||
1992|007|Z|professional for complete information about this product and your||
1992|008|Z|specific health needs.||
1992|009|B|||
1992|010|T|OMADACYCLINE - ORAL||
1992|011|F|(oh-MAD-a-SYE-kleen)||
1992|012|B|||
1992|013|C|COMMON BRAND NAME(S): Nuzyra||
1992|014|B|||
1992|015|U|USES:  Omadacycline is used to treat a wide variety of bacterial||
1992|016|U|infections. This medication belongs to a class of drugs known as||
1992|017|U|tetracycline antibiotics. It works by stopping the growth of||
1992|018|U|bacteria.||
1992|019|U|   This antibiotic treats only bacterial infections. It will not||
1992|020|U|work for viral infections (such as common cold, flu). Using any||
1992|021|U|antibiotic when it is not needed can cause it to not work for||
1992|022|U|future infections.||
1992|023|B|||
1992|024|H|HOW TO USE:  Take this medication by mouth on an empty stomach as||
1992|025|H|directed by your doctor, usually once daily. Fast for at least 4||
1992|026|H|hours before your dose, then take your dose with a full glass of||
1992|027|H|water (8 ounces/240 milliliters) unless your doctor directs you||
1992|028|H|otherwise. After taking this medication, you may drink water, but||
1992|029|H|do not eat food or drink other liquids for 2 hours after taking||
1992|030|H|this medication. Also, do not lie down for at least 10 minutes||
1992|031|H|after taking your dose.||
1992|032|H|   Take this medication at least 4 hours before or after taking||
1992|033|H|any products containing aluminum, calcium, iron, magnesium, zinc,||
1992|034|H|or bismuth subsalicylate. Some examples include antacids,||
1992|035|H|quinapril, sucralfate, vitamins/minerals, dairy products (such as||
1992|036|H|milk, yogurt), and juice with added calcium. These products bind||
1992|037|H|with omadacycline, preventing your body from fully absorbing the||
1992|038|H|drug.||
1992|039|H|   The dosage and length of treatment are based on your medical||
1992|040|H|condition and response to treatment.||
1992|041|H|   For the best effect, take this antibiotic at evenly spaced||
1992|042|H|times. To help you remember, take this medication at the same||
1992|043|H|time every day.||
1992|044|H|   Continue to take this medication until the full prescribed||
1992|045|H|amount is finished, even if symptoms disappear after a few days.||
1992|046|H|Stopping the medication too early may result in a return of the||
1992|047|H|infection.||
1992|048|H|   Tell your doctor if your condition does not get better or if||
1992|049|H|it gets worse.||
1992|050|B|||
1992|051|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. If any of||
1992|052|S|these effects last or get worse, tell your doctor or pharmacist||
1992|053|S|promptly.||
1992|054|S|   Remember that this medication has been prescribed because your||
1992|055|S|doctor has judged that the benefit to you is greater than the||
1992|056|S|risk of side effects. Many people using this medication do not||
1992|057|S|have serious side effects.||
1992|058|S|   Tell your doctor right away if you have any serious side||
1992|059|S|effects, including: painful/difficult swallowing, hearing changes||
1992|060|S|(such as ringing in the ears, decreased hearing), signs of kidney||
1992|061|S|problems (such as change in the amount of urine, pink urine),||
1992|062|S|signs of liver problems (such as loss of appetite,||
1992|063|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
1992|064|S|   Omadacycline may rarely cause increased pressure around the||
1992|065|S|brain (intracranial hypertension-IH). The risk of this side||
1992|066|S|effect is greater for women of childbearing age who are||
1992|067|S|overweight or who have had IH in the past. If IH develops, it||
1992|068|S|usually goes away after omadacycline is stopped; however, there||
1992|069|S|is a chance of permanent vision loss or blindness. Get medical||
1992|070|S|help right away if you have: severe/lasting headache, vision||
1992|071|S|changes (such as blurred/double vision, decreased vision, sudden||
1992|072|S|blindness), nausea/vomiting that doesn't stop.||
1992|073|S|   This medication may rarely cause a severe intestinal condition||
1992|074|S|due to a bacteria called C. difficile. This condition may occur||
1992|075|S|during treatment or weeks to months after treatment has stopped.||
1992|076|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1992|077|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1992|078|S|stool.||
1992|079|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1992|080|S|products because they may make symptoms worse.||
1992|081|S|   Use of this medication for prolonged or repeated periods may||
1992|082|S|result in oral thrush or a new yeast infection. Contact your||
1992|083|S|doctor if you notice white patches in your mouth, a change in||
1992|084|S|vaginal discharge, or other new symptoms.||
1992|085|S|   A very serious allergic reaction to this drug is rare.||
1992|086|S|However, get medical help right away if you notice any symptoms||
1992|087|S|of a serious allergic reaction, including: fever that doesn't go||
1992|088|S|away, new or worsening lymph node swelling, rash,||
1992|089|S|itching/swelling (especially of the face/tongue/throat), severe||
1992|090|S|dizziness, trouble breathing.||
1992|091|S|   This is not a complete list of possible side effects. If you||
1992|092|S|notice other effects not listed above, contact your doctor or||
1992|093|S|pharmacist.||
1992|094|S|   In the US -||
1992|095|S|   Call your doctor for medical advice about side effects. You||
1992|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1992|097|S|www.fda.gov/medwatch.||
1992|098|S|   In Canada - Call your doctor for medical advice about side||
1992|099|S|effects. You may report side effects to Health Canada at||
1992|100|S|1-866-234-2345.||
1992|101|B|||
1992|102|P|PRECAUTIONS:  Before taking omadacycline, tell your doctor or||
1992|103|P|pharmacist if you are allergic to it; or to other tetracyclines||
1992|104|P|(such as doxycycline); or if you have any other allergies. This||
1992|105|P|product may contain inactive ingredients, which can cause||
1992|106|P|allergic reactions or other problems. Talk to your pharmacist for||
1992|107|P|more details.||
1992|108|P|   Before using this medication, tell your doctor or pharmacist||
1992|109|P|your medical history, especially of: kidney problems, liver||
1992|110|P|problems, trouble swallowing, esophagus problems (such as hiatal||
1992|111|P|hernia or reflux/heartburn).||
1992|112|P|   This medication may make you more sensitive to the sun. Limit||
1992|113|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1992|114|P|sunscreen and wear protective clothing when outdoors. Tell your||
1992|115|P|doctor right away if you get sunburned or have skin||
1992|116|P|blisters/redness.||
1992|117|P|   Omadacycline may cause live bacterial vaccines (such as||
1992|118|P|typhoid vaccine) to not work well. Tell your health care||
1992|119|P|professional that you are using omadacycline before having any||
1992|120|P|immunizations/vaccinations.||
1992|121|P|   Before having surgery, tell your doctor or dentist about all||
1992|122|P|the products you use (including prescription drugs,||
1992|123|P|nonprescription drugs, and herbal products).||
1992|124|P|   Children younger than 8 years may be more sensitive to the||
1992|125|P|side effects of omadacycline, especially tooth staining. Tooth||
1992|126|P|staining has also happened to older children and young adults.||
1992|127|P|Discuss the risks and benefits of this medication with the||
1992|128|P|doctor.||
1992|129|P|   Tell your doctor if you are pregnant or plan to become||
1992|130|P|pregnant. You should not become pregnant while using||
1992|131|P|omadacycline. Omadacycline may harm an unborn baby. If you become||
1992|132|P|pregnant, talk to your doctor right away about the risks and||
1992|133|P|benefits of this medication.||
1992|134|P|   It is unknown if this medication passes into breast milk.||
1992|135|P|Consult your doctor before breastfeeding.||
1992|136|B|||
1992|137|I|DRUG INTERACTIONS:  See also How to Use section.||
1992|138|I|   Drug interactions may change how your medications work or||
1992|139|I|increase your risk for serious side effects. This document does||
1992|140|I|not contain all possible drug interactions. Keep a list of all||
1992|141|I|the products you use (including prescription/nonprescription||
1992|142|I|drugs and herbal products) and share it with your doctor and||
1992|143|I|pharmacist. Do not start, stop, or change the dosage of any||
1992|144|I|medicines without your doctor's approval.||
1992|145|I|   Some products that may interact with this drug are: retinoid||
1992|146|I|medications taken by mouth (such as acitretin, isotretinoin),||
1992|147|I|strontium.||
1992|148|I|   This medication may interfere with certain lab tests (such as||
1992|149|I|urine catecholamine levels), possibly causing false test results.||
1992|150|I|Make sure lab personnel and all your doctors know you use this||
1992|151|I|drug.||
1992|152|B|||
1992|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1992|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1992|155|O|poison control center right away. US residents can call||
1992|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1992|157|B|||
1992|158|N|NOTES:  Do not share this medication with others.||
1992|159|N|   This medication has been prescribed for your current condition||
1992|160|N|only. Do not use it later for another infection unless your||
1992|161|N|doctor tells you to.||
1992|162|N|   If you are taking this medication for a longer time, lab||
1992|163|N|and/or medical tests (such as complete blood count, kidney/liver||
1992|164|N|function) may be done. Keep all medical and lab appointments.||
1992|165|B|||
1992|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1992|167|D|remember. If it is near the time of the next dose, skip the||
1992|168|D|missed dose. Take your next dose at the regular time. Do not||
1992|169|D|double the dose to catch up.||
1992|170|B|||
1992|171|R|STORAGE:  Store at room temperature away from light and moisture.||
1992|172|R|Do not store in the bathroom. Keep all medications away from||
1992|173|R|children and pets.||
1992|174|R|   Do not flush medications down the toilet or pour them into a||
1992|175|R|drain unless instructed to do so. Properly discard this product||
1992|176|R|when it is expired or no longer needed. Taking outdated||
1992|177|R|tetracycline-related drugs can result in serious illness. Consult||
1992|178|R|your pharmacist or local waste disposal company.||
1992|179|B|||
1992|180|A|Information last revised September 2025.||
1992|181|A|Copyright(c) 2025 First Databank, Inc.||
1992|182|B|||
1993|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1993|002|Z|does NOT have all possible information about this product. This||
1993|003|Z|information does not assure that this product is safe, effective,||
1993|004|Z|or appropriate for you. This information is not individual||
1993|005|Z|medical advice and does not substitute for the advice of your||
1993|006|Z|health care professional. Always ask your health care||
1993|007|Z|professional for complete information about this product and your||
1993|008|Z|specific health needs.||
1993|009|B|||
1993|010|T|SARECYCLINE - ORAL||
1993|011|F|(SAR-e-SYE-kleen)||
1993|012|B|||
1993|013|C|COMMON BRAND NAME(S): Seysara||
1993|014|B|||
1993|015|U|USES:  Sarecycline is used to treat moderate to severe acne. This||
1993|016|U|medication belongs to a class of drugs known as tetracycline||
1993|017|U|antibiotics. It is thought to work by slowing or stopping the||
1993|018|U|growth of certain bacteria on the skin. It may also lessen||
1993|019|U|redness and swelling caused by acne lesions.||
1993|020|U|   This antibiotic treats only bacterial infections. It will not||
1993|021|U|work for viral infections (such as common cold, flu). Using any||
1993|022|U|antibiotic when it is not needed can cause it to not work for||
1993|023|U|future infections.||
1993|024|B|||
1993|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1993|026|H|from your pharmacist before you start taking sarecycline and each||
1993|027|H|time you get a refill. If you have any questions, ask your doctor||
1993|028|H|or pharmacist.||
1993|029|H|   Take this medication by mouth with or without food as directed||
1993|030|H|by your doctor, usually once daily. Take this medication with a||
1993|031|H|full glass of water (8 ounces/240 milliliters) unless your doctor||
1993|032|H|directs you otherwise. Do not lie down for at least 10 minutes||
1993|033|H|after taking this medication. The dosage is based on your medical||
1993|034|H|condition, weight, and response to treatment.||
1993|035|H|   Take this medication 2 to 3 hours before or after taking any||
1993|036|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
1993|037|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
1993|038|H|sucralfate, vitamins/minerals, dairy products (such as milk,||
1993|039|H|yogurt), and juice with added calcium. These products bind with||
1993|040|H|sarecycline, preventing your body from fully absorbing the drug.||
1993|041|H|   For the best effect, take this antibiotic at evenly spaced||
1993|042|H|times. To help you remember, take this medication at the same||
1993|043|H|time every day.||
1993|044|H|   Continue to take this medication until the full prescribed||
1993|045|H|amount is finished, even if your condition gets better after a||
1993|046|H|few days. Stopping the medication too early may result in||
1993|047|H|worsening acne.||
1993|048|H|   Tell your doctor if your condition does not get better or if||
1993|049|H|it gets worse.||
1993|050|B|||
1993|051|S|SIDE EFFECTS:  Nausea, lightheadedness, dizziness, or a feeling||
1993|052|S|of spinning may occur. If any of these effects last or get worse,||
1993|053|S|tell your doctor or pharmacist promptly.||
1993|054|S|   Remember that this medication has been prescribed because your||
1993|055|S|doctor has judged that the benefit to you is greater than the||
1993|056|S|risk of side effects. Many people using this medication do not||
1993|057|S|have serious side effects.||
1993|058|S|   Tell your doctor right away if you have any serious side||
1993|059|S|effects, including: painful/difficult swallowing, signs of kidney||
1993|060|S|problems (such as change in the amount of urine).||
1993|061|S|   Tetracycline drugs such as sarecycline may rarely cause||
1993|062|S|increased pressure around the brain (intracranial||
1993|063|S|hypertension-IH). The risk of this side effect is greater for||
1993|064|S|women of childbearing age who are overweight or who have had IH||
1993|065|S|in the past. If IH develops, it usually goes away after||
1993|066|S|sarecycline is stopped; however, there is a chance of permanent||
1993|067|S|vision loss or blindness. Get medical help right away if you||
1993|068|S|have: severe/lasting headache, vision changes (such as||
1993|069|S|blurred/double vision, decreased vision, sudden blindness),||
1993|070|S|nausea/vomiting that doesn't stop.||
1993|071|S|   This medication may rarely cause a severe intestinal condition||
1993|072|S|due to a bacteria called C. difficile. This condition may occur||
1993|073|S|during treatment or weeks to months after treatment has stopped.||
1993|074|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1993|075|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1993|076|S|stool.||
1993|077|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1993|078|S|products because they may make symptoms worse.||
1993|079|S|   Use of this medication for prolonged or repeated periods may||
1993|080|S|result in oral thrush or a new vaginal yeast infection. Contact||
1993|081|S|your doctor if you notice white patches in your mouth, a change||
1993|082|S|in vaginal discharge, or other new symptoms.||
1993|083|S|   A very serious allergic reaction to this drug is rare.||
1993|084|S|However, get medical help right away if you notice any symptoms||
1993|085|S|of a serious allergic reaction, including: fever that doesn't go||
1993|086|S|away, new or worsening lymph node swelling, rash,||
1993|087|S|itching/swelling (especially of the face/tongue/throat), severe||
1993|088|S|dizziness, trouble breathing.||
1993|089|S|   This is not a complete list of possible side effects. If you||
1993|090|S|notice other effects not listed above, contact your doctor or||
1993|091|S|pharmacist.||
1993|092|S|   In the US -||
1993|093|S|   Call your doctor for medical advice about side effects. You||
1993|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1993|095|S|www.fda.gov/medwatch.||
1993|096|S|   In Canada - Call your doctor for medical advice about side||
1993|097|S|effects. You may report side effects to Health Canada at||
1993|098|S|1-866-234-2345.||
1993|099|B|||
1993|100|P|PRECAUTIONS:  Before taking sarecycline, tell your doctor or||
1993|101|P|pharmacist if you are allergic to it; or to other tetracyclines||
1993|102|P|(such as doxycycline); or if you have any other allergies. This||
1993|103|P|product may contain inactive ingredients, which can cause||
1993|104|P|allergic reactions or other problems. Talk to your pharmacist for||
1993|105|P|more details.||
1993|106|P|   Before using this medication, tell your doctor or pharmacist||
1993|107|P|your medical history, especially of: trouble swallowing,||
1993|108|P|esophagus problems (such as hiatal hernia or reflux/heartburn).||
1993|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1993|110|P|can make you more dizzy. Do not drive, use machinery, or do||
1993|111|P|anything that needs alertness until you can do it safely. Limit||
1993|112|P|alcoholic beverages. Talk to your doctor if you are using||
1993|113|P|marijuana (cannabis).||
1993|114|P|   This medication may make you more sensitive to the sun. Limit||
1993|115|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
1993|116|P|sunscreen and wear protective clothing when outdoors. Tell your||
1993|117|P|doctor right away if you get sunburned or have skin||
1993|118|P|blisters/redness.||
1993|119|P|   Sarecycline may cause live bacterial vaccines (such as typhoid||
1993|120|P|vaccine) to not work well. Tell your health care professional||
1993|121|P|that you are using sarecycline before having any||
1993|122|P|immunizations/vaccinations.||
1993|123|P|   Before having surgery, tell your doctor or dentist about all||
1993|124|P|the products you use (including prescription drugs,||
1993|125|P|nonprescription drugs, and herbal products).||
1993|126|P|   Children younger than 8 years may be more sensitive to the||
1993|127|P|side effects of sarecycline, especially tooth staining. Tooth||
1993|128|P|staining has also happened to older children and young adults.||
1993|129|P|Discuss the risks and benefits of this medication with the||
1993|130|P|doctor.||
1993|131|P|   Tell your doctor if you are pregnant or plan to become||
1993|132|P|pregnant. You should not become pregnant while using sarecycline.||
1993|133|P|Sarecycline may harm an unborn baby. If you become pregnant, talk||
1993|134|P|to your doctor right away about the risks and benefits of this||
1993|135|P|medication.||
1993|136|P|   It is unknown if this medication passes into breast milk.||
1993|137|P|Consult your doctor before breastfeeding.||
1993|138|B|||
1993|139|I|DRUG INTERACTIONS:  See also How to Use section.||
1993|140|I|   Drug interactions may change how your medications work or||
1993|141|I|increase your risk for serious side effects. This document does||
1993|142|I|not contain all possible drug interactions. Keep a list of all||
1993|143|I|the products you use (including prescription/nonprescription||
1993|144|I|drugs and herbal products) and share it with your doctor and||
1993|145|I|pharmacist. Do not start, stop, or change the dosage of any||
1993|146|I|medicines without your doctor's approval.||
1993|147|I|   Some products that may interact with this drug are: retinoid||
1993|148|I|medications taken by mouth (such as acitretin, isotretinoin),||
1993|149|I|strontium.||
1993|150|I|   This medication may interfere with certain lab tests||
1993|151|I|(including urine catecholamine levels), possibly causing false||
1993|152|I|test results. Make sure lab personnel and all your doctors know||
1993|153|I|you use this drug.||
1993|154|B|||
1993|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1993|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1993|157|O|poison control center right away. US residents can call||
1993|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1993|159|B|||
1993|160|N|NOTES:  Do not share this medication with others.||
1993|161|N|   This medication has been prescribed for your current condition||
1993|162|N|only. Do not use it later for another infection unless your||
1993|163|N|doctor tells you to.||
1993|164|N|   If you are taking this medication for a longer time, lab||
1993|165|N|and/or medical tests (such as complete blood count, kidney/liver||
1993|166|N|function) may be done. Keep all medical and lab appointments.||
1993|167|B|||
1993|168|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1993|169|D|remember. If it is near the time of the next dose, skip the||
1993|170|D|missed dose. Take your next dose at the regular time. Do not||
1993|171|D|double the dose to catch up.||
1993|172|B|||
1993|173|R|STORAGE:  Store at room temperature away from light and moisture.||
1993|174|R|Do not store in the bathroom. Keep all medications away from||
1993|175|R|children and pets.||
1993|176|R|   Do not flush medications down the toilet or pour them into a||
1993|177|R|drain unless instructed to do so. Properly discard this product||
1993|178|R|when it is expired or no longer needed. Taking outdated||
1993|179|R|tetracycline-related drugs can result in serious illness. Consult||
1993|180|R|your pharmacist or local waste disposal company.||
1993|181|B|||
1993|182|A|Information last revised September 2025.||
1993|183|A|Copyright(c) 2025 First Databank, Inc.||
1993|184|B|||
1994|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1994|002|Z|does NOT have all possible information about this product. This||
1994|003|Z|information does not assure that this product is safe, effective,||
1994|004|Z|or appropriate for you. This information is not individual||
1994|005|Z|medical advice and does not substitute for the advice of your||
1994|006|Z|health care professional. Always ask your health care||
1994|007|Z|professional for complete information about this product and your||
1994|008|Z|specific health needs.||
1994|009|B|||
1994|010|T|RIFAMYCIN DELAYED-RELEASE - ORAL||
1994|011|F|(RIF-a-MYE-sin)||
1994|012|B|||
1994|013|C|COMMON BRAND NAME(S): Aemcolo||
1994|014|B|||
1994|015|U|USES:  Rifamycin is used to treat diarrhea caused by the common||
1994|016|U|bacteria known as E. coli ("traveler's diarrhea"). It works by||
1994|017|U|stopping the growth of bacteria.||
1994|018|U|   This antibiotic treats only bacterial infections. It will not||
1994|019|U|work for viral infections (such as common cold, flu). Using any||
1994|020|U|antibiotic when it is not needed can cause it to not work for||
1994|021|U|future infections.||
1994|022|U|   This medication should not be used if you have a fever or||
1994|023|U|bloody diarrhea.||
1994|024|B|||
1994|025|H|HOW TO USE:  Take this medication by mouth with or without food||
1994|026|H|as directed by your doctor, usually twice a day (morning and||
1994|027|H|evening) for 3 days. Swallow the tablets whole with a glass of||
1994|028|H|liquid (6 to 8 ounces/180 to 240 milliliters). Do not take this||
1994|029|H|medication with alcohol. Do not crush, break, or chew the||
1994|030|H|tablets. Doing so can release all of the drug at once, increasing||
1994|031|H|the risk of side effects. The dosage is based on your medical||
1994|032|H|condition and response to treatment.||
1994|033|H|   For the best effect, take this antibiotic at evenly spaced||
1994|034|H|times. To help you remember, take this medication at the same||
1994|035|H|times every day.||
1994|036|H|   Continue to take this medication until the full prescribed||
1994|037|H|amount is finished, even if symptoms disappear after a few days.||
1994|038|H|Stopping the medication too early may result in a return of the||
1994|039|H|infection.||
1994|040|H|   Tell your doctor if you develop a fever or bloody diarrhea, or||
1994|041|H|if your condition does not get better, or if it gets worse after||
1994|042|H|2 days.||
1994|043|B|||
1994|044|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
1994|045|S|because your doctor has judged that the benefit to you is greater||
1994|046|S|than the risk of side effects. Many people using this medication||
1994|047|S|do not have serious side effects.||
1994|048|S|   This medication may rarely cause a severe intestinal condition||
1994|049|S|due to a bacteria called C. difficile. This condition may occur||
1994|050|S|during treatment or weeks to months after treatment has stopped.||
1994|051|S|Tell your doctor right away if you develop: diarrhea that doesn't||
1994|052|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
1994|053|S|stool.||
1994|054|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
1994|055|S|products because they may make symptoms worse.||
1994|056|S|   A very serious allergic reaction to this drug is rare.||
1994|057|S|However, get medical help right away if you notice any symptoms||
1994|058|S|of a serious allergic reaction, including: rash, itching/swelling||
1994|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1994|060|S|breathing.||
1994|061|S|   This is not a complete list of possible side effects. If you||
1994|062|S|notice other effects not listed above, contact your doctor or||
1994|063|S|pharmacist.||
1994|064|S|   In the US -||
1994|065|S|   Call your doctor for medical advice about side effects. You||
1994|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1994|067|S|www.fda.gov/medwatch.||
1994|068|S|   In Canada - Call your doctor for medical advice about side||
1994|069|S|effects. You may report side effects to Health Canada at||
1994|070|S|1-866-234-2345.||
1994|071|B|||
1994|072|P|PRECAUTIONS:  Before taking rifamycin, tell your doctor or||
1994|073|P|pharmacist if you are allergic to it; or to other rifamycins||
1994|074|P|(such as rifampicin, rifaximin); or if you have any other||
1994|075|P|allergies. This product may contain inactive ingredients, which||
1994|076|P|can cause allergic reactions or other problems. Talk to your||
1994|077|P|pharmacist for more details.||
1994|078|P|   Before using this medication, tell your doctor or pharmacist||
1994|079|P|your medical history.||
1994|080|P|   Rifamycin may cause live bacterial vaccines (such as typhoid||
1994|081|P|vaccine) to not work well. Tell your health care professional||
1994|082|P|that you are using rifamycin before having any||
1994|083|P|immunizations/vaccinations.||
1994|084|P|   Before having surgery, tell your doctor or dentist about all||
1994|085|P|the products you use (including prescription drugs,||
1994|086|P|nonprescription drugs, and herbal products).||
1994|087|P|   During pregnancy, this medication should be used only when||
1994|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
1994|089|P|   It is unknown if this drug passes into breast milk. Consult||
1994|090|P|your doctor before breastfeeding.||
1994|091|B|||
1994|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1994|093|I|medications work or increase your risk for serious side effects.||
1994|094|I|This document does not contain all possible drug interactions.||
1994|095|I|Keep a list of all the products you use (including||
1994|096|I|prescription/nonprescription drugs and herbal products) and share||
1994|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
1994|098|I|the dosage of any medicines without your doctor's approval.||
1994|099|B|||
1994|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1994|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1994|102|O|poison control center right away. US residents can call||
1994|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1994|104|B|||
1994|105|N|NOTES:  Do not share this medication with others.||
1994|106|N|   This medication has been prescribed for your current condition||
1994|107|N|only. Do not use it later for another infection unless your||
1994|108|N|doctor tells you to.||
1994|109|B|||
1994|110|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1994|111|D|remember. If it is near the time of the next dose, skip the||
1994|112|D|missed dose. Take your next dose at the regular time. Do not||
1994|113|D|double the dose to catch up.||
1994|114|B|||
1994|115|R|STORAGE:  Store at room temperature away from light and moisture.||
1994|116|R|Do not store in the bathroom. Keep all medications away from||
1994|117|R|children and pets.||
1994|118|R|   Do not flush medications down the toilet or pour them into a||
1994|119|R|drain unless instructed to do so. Properly discard this product||
1994|120|R|when it is expired or no longer needed. Consult your pharmacist||
1994|121|R|or local waste disposal company.||
1994|122|B|||
1994|123|A|Information last revised May 2024.||
1994|124|A|Copyright(c) 2025 First Databank, Inc.||
1994|125|B|||
1995|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1995|002|Z|does NOT have all possible information about this product. This||
1995|003|Z|information does not assure that this product is safe, effective,||
1995|004|Z|or appropriate for you. This information is not individual||
1995|005|Z|medical advice and does not substitute for the advice of your||
1995|006|Z|health care professional. Always ask your health care||
1995|007|Z|professional for complete information about this product and your||
1995|008|Z|specific health needs.||
1995|009|B|||
1995|010|T|TAFENOQUINE - ORAL||
1995|011|F|(ta-FEN-oh-kwin)||
1995|012|B|||
1995|013|C|COMMON BRAND NAME(S): Arakoda||
1995|014|B|||
1995|015|U|USES:  This medication is used to prevent malaria. It works by||
1995|016|U|stopping the growth of the parasite that causes malaria.||
1995|017|B|||
1995|018|H|HOW TO USE:  Read the Medication Guide provided by your||
1995|019|H|pharmacist before you start taking tafenoquine and each time you||
1995|020|H|get a refill. If you have any questions, ask your doctor or||
1995|021|H|pharmacist.||
1995|022|H|   Take this medication by mouth with food as directed by your||
1995|023|H|doctor. The manufacturer directs to swallow this medication||
1995|024|H|whole, and to not break, crush, or chew the tablet before taking||
1995|025|H|it. However, many similar drugs (immediate-release tablets) can||
1995|026|H|be split, crushed, or chewed. Follow your doctor's directions on||
1995|027|H|how to take this medication.||
1995|028|H|   Take this medication starting 3 days before you travel to an||
1995|029|H|area with malaria, usually once daily for 3 days. While you are||
1995|030|H|in the malarious area, take this medication usually once each||
1995|031|H|week, starting 7 days after the last daily dose you took. After||
1995|032|H|you leave the malarious area, take the last dose of this||
1995|033|H|medication 7 days after the last dose you took while you were in||
1995|034|H|the malarious area.||
1995|035|H|   For the best effect, take this medication at evenly spaced||
1995|036|H|times. To help you remember, take this medication at the same||
1995|037|H|time every day when you take it daily, and on the same day of the||
1995|038|H|week when you take it weekly.||
1995|039|H|   It is important that you do not miss any doses. See the Missed||
1995|040|H|Dose section for more information.||
1995|041|H|   Continue to take this medication until the full prescribed||
1995|042|H|amount is finished. Stopping the medication too early may result||
1995|043|H|in loss of protection against getting malaria.||
1995|044|H|   No medication is completely effective in preventing malaria.||
1995|045|H|Get medical help right away if you develop symptoms of malaria||
1995|046|H|(such as fever, chills, headache, other flu-like symptoms).||
1995|047|H|Malaria is best treated when treatment is started early.||
1995|048|B|||
1995|049|S|SIDE EFFECTS:  Tafenoquine stays in your body a long time, so||
1995|050|S|side effects may be delayed or last longer than expected.||
1995|051|S|   Trouble sleeping, anxiety, or nightmares may occur. If any of||
1995|052|S|these effects last more than 3 days or get worse, tell your||
1995|053|S|doctor or pharmacist promptly.||
1995|054|S|   Remember that this medication has been prescribed because your||
1995|055|S|doctor has judged that the benefit to you is greater than the||
1995|056|S|risk of side effects. Many people using this medication do not||
1995|057|S|have serious side effects.||
1995|058|S|   Tell your doctor right away if you have any serious side||
1995|059|S|effects, including: eye/vision problems.||
1995|060|S|   Get medical help right away if you have any very serious side||
1995|061|S|effects, including: mental/mood changes (such as hallucinations,||
1995|062|S|unusual thoughts/behavior, confusion), unusual tiredness, rapid||
1995|063|S|breathing, pale skin, shortness of breath, fast heartbeat,||
1995|064|S|dizziness/lightheadedness, bluish lips or skin, headache that||
1995|065|S|lasts or is severe, yellowing eyes/skin, dark urine.||
1995|066|S|   A very serious allergic reaction to this drug is rare.||
1995|067|S|However, get medical help right away if you notice any symptoms||
1995|068|S|of a serious allergic reaction, including: rash, itching/swelling||
1995|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1995|070|S|breathing.||
1995|071|S|   This is not a complete list of possible side effects. If you||
1995|072|S|notice other effects not listed above, contact your doctor or||
1995|073|S|pharmacist.||
1995|074|S|   In the US -||
1995|075|S|   Call your doctor for medical advice about side effects. You||
1995|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1995|077|S|www.fda.gov/medwatch.||
1995|078|S|   In Canada - Call your doctor for medical advice about side||
1995|079|S|effects. You may report side effects to Health Canada at||
1995|080|S|1-866-234-2345.||
1995|081|B|||
1995|082|P|PRECAUTIONS:  Before taking tafenoquine, tell your doctor or||
1995|083|P|pharmacist if you are allergic to it; or to chloroquine or||
1995|084|P|primaquine; or if you have any other allergies. This product may||
1995|085|P|contain inactive ingredients, which can cause allergic reactions||
1995|086|P|or other problems. Talk to your pharmacist for more details.||
1995|087|P|   Before using this medication, tell your doctor or pharmacist||
1995|088|P|your medical history, especially of: mental/mood disorders (such||
1995|089|P|as psychosis, schizophrenia, hallucinations, delusions,||
1995|090|P|disorganized thinking/behavior), certain enzyme deficiencies||
1995|091|P|(G6PD deficiency, NADH-dependent methemoglobin reductase||
1995|092|P|deficiency).||
1995|093|P|   Before having surgery, tell your doctor or dentist about all||
1995|094|P|the products you use (including prescription drugs,||
1995|095|P|nonprescription drugs, and herbal products).||
1995|096|P|   Tell your doctor if you are pregnant or plan to become||
1995|097|P|pregnant. You should not become pregnant while using tafenoquine.||
1995|098|P|Tafenoquine may harm an unborn baby. Your doctor should order a||
1995|099|P|pregnancy test before you start this medication. Ask about||
1995|100|P|reliable forms of birth control while using this medication and||
1995|101|P|for 3 months after the last dose. If you become pregnant, talk to||
1995|102|P|your doctor right away about the risks and benefits of this||
1995|103|P|medication and about switching to another anti-malarial drug.||
1995|104|P|   It is unknown if this medication passes into breast milk. A||
1995|105|P|blood test to check if your baby has G6PD deficiency should be||
1995|106|P|done before you start breastfeeding. If your baby is G6PD||
1995|107|P|deficient or if the G6PD status is unknown, breastfeeding is not||
1995|108|P|recommended while using this medication and for 3 months after||
1995|109|P|the last dose. Consult your doctor before breastfeeding.||
1995|110|B|||
1995|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1995|112|I|medications work or increase your risk for serious side effects.||
1995|113|I|This document does not contain all possible drug interactions.||
1995|114|I|Keep a list of all the products you use (including||
1995|115|I|prescription/nonprescription drugs and herbal products) and share||
1995|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
1995|117|I|the dosage of any medicines without your doctor's approval.||
1995|118|I|   This medication can slow down the removal of other medications||
1995|119|I|from your body, which may affect how they work. One example is||
1995|120|I|dofetilide, among others.||
1995|121|B|||
1995|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1995|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1995|124|O|poison control center right away. US residents can call||
1995|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1995|126|B|||
1995|127|N|NOTES:  Do not share this medication with others.||
1995|128|N|   Lab and/or medical tests (such as G6PD deficiency) should be||
1995|129|N|done before you start taking this medication. Keep all medical||
1995|130|N|and lab appointments.||
1995|131|B|||
1995|132|D|MISSED DOSE:  If you miss a dose, follow the instructions in the||
1995|133|D|Medication Guide.||
1995|134|D|   If you miss 1 daily dose before you travel to the malarious||
1995|135|D|area, take the missed dose so that a total of 3 daily doses have||
1995|136|D|been taken. Start taking your weekly dose 1 week after your last||
1995|137|D|daily dose.||
1995|138|D|   If you miss 2 daily doses before you travel to the malarious||
1995|139|D|area, take the daily missed dose each day for 2 days in a row so||
1995|140|D|that a total of 3 daily doses have been taken. Start taking your||
1995|141|D|weekly dose 1 week after your last daily dose.||
1995|142|D|   If you miss 1 weekly dose, take the missed dose on any day up||
1995|143|D|to the time of the next scheduled weekly dose.||
1995|144|D|   If you miss 2 weekly doses, take one weekly missed dose on any||
1995|145|D|day up to the time of the next scheduled weekly dose.||
1995|146|D|   If you miss 3 or more weekly doses, take one weekly missed||
1995|147|D|dose as a once-daily dose for 2 days up to the time of the next||
1995|148|D|scheduled weekly dose.||
1995|149|D|   If you miss your last dose of medication 7 days after the last||
1995|150|D|dose that you took while in the malarious area, take this last||
1995|151|D|dose as soon as you remember.||
1995|152|B|||
1995|153|R|STORAGE:  Store at room temperature away from light and moisture.||
1995|154|R|Do not store in the bathroom. Keep all medications away from||
1995|155|R|children and pets.||
1995|156|R|   Do not flush medications down the toilet or pour them into a||
1995|157|R|drain unless instructed to do so. Properly discard this product||
1995|158|R|when it is expired or no longer needed. Consult your pharmacist||
1995|159|R|or local waste disposal company.||
1995|160|B|||
1995|161|A|Information last revised May 2024.||
1995|162|A|Copyright(c) 2025 First Databank, Inc.||
1995|163|B|||
1996|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1996|002|Z|does NOT have all possible information about this product. This||
1996|003|Z|information does not assure that this product is safe, effective,||
1996|004|Z|or appropriate for you. This information is not individual||
1996|005|Z|medical advice and does not substitute for the advice of your||
1996|006|Z|health care professional. Always ask your health care||
1996|007|Z|professional for complete information about this product and your||
1996|008|Z|specific health needs.||
1996|009|B|||
1996|010|T|RAVULIZUMAB - INJECTION||
1996|011|F|(RAV-ue-LIZ-ue-mab)||
1996|012|B|||
1996|013|C|COMMON BRAND NAME(S): Ultomiris||
1996|014|B|||
1996|015|W|WARNING:  Ravulizumab can lower your body's ability to fight||
1996|016|W|infections. This increases your chance of getting very serious||
1996|017|W|(possibly fatal) infections (especially meningitis or sepsis).||
1996|018|W|Get medical help right away if you develop symptoms such as||
1996|019|W|nausea/vomiting that doesn't stop, high fever, chills, severe||
1996|020|W|headache, stiff neck, mental/mood changes (such as confusion),||
1996|021|W|eye sensitivity to light.||
1996|022|W|   You should receive the vaccine for meningitis (meningococcal||
1996|023|W|vaccine) at least 2 weeks before receiving this medication. If||
1996|024|W|you have been vaccinated for meningitis in the past, ask your||
1996|025|W|doctor if you should get another vaccination (booster shot)||
1996|026|W|before receiving this medication. Vaccines may not fully protect||
1996|027|W|everyone who receives them, so you should still watch for signs||
1996|028|W|of meningitis after you get the vaccine.||
1996|029|W|   To receive ravulizumab in the United States, you must||
1996|030|W|understand, agree to, and carefully follow the requirements of||
1996|031|W|the REMS Program for this medication. If you live in Canada or||
1996|032|W|any other country, consult your doctor and pharmacist for your||
1996|033|W|country's regulations.||
1996|034|B|||
1996|035|U|USES:  Ravulizumab is used to treat a certain blood disorder||
1996|036|U|(paroxysmal nocturnal hemoglobinuria). This disorder causes your||
1996|037|U|body's immune system to destroy red blood cells, which results in||
1996|038|U|anemia. It works by helping block your body's destruction of red||
1996|039|U|blood cells. This effect helps lessen symptoms of anemia (such as||
1996|040|U|tiredness, shortness of breath), and may reduce the need for||
1996|041|U|blood transfusions.||
1996|042|U|   This medication may also be used to treat a certain immune||
1996|043|U|system disorder (atypical Hemolytic Uremic Syndrome). It helps to||
1996|044|U|prevent blood clots caused by this disorder.||
1996|045|U|   Ravulizumab may be used to treat a certain muscle condition||
1996|046|U|(generalized myasthenia gravis). It may help to improve symptoms||
1996|047|U|of muscle weakness.||
1996|048|U|   This medication is also used to treat a certain nervous system||
1996|049|U|disorder that affects the spinal cord and eye nerve||
1996|050|U|(neuromyelitis optica spectrum disorder). It may help to reduce||
1996|051|U|the number of hospital stays due to the disease. Ravulizumab||
1996|052|U|belongs to a class of medications known as monoclonal antibodies.||
1996|053|B|||
1996|054|H|HOW TO USE:  Read the Medication Guide provided by your||
1996|055|H|pharmacist before you start using ravulizumab and each time you||
1996|056|H|get an infusion. Carry the Patient Safety Card with you at all||
1996|057|H|times during treatment and for 8 months after your last dose of||
1996|058|H|ravulizumab. If you have any questions, ask your doctor or||
1996|059|H|pharmacist.||
1996|060|H|   This medication is given by slow injection into a vein by a||
1996|061|H|health care professional as directed by your doctor. After the||
1996|062|H|first dose, it is usually given 2 weeks later, then every 4 or||
1996|063|H|every 8 weeks. The dosage is based on your medical condition,||
1996|064|H|weight, and response to treatment.||
1996|065|H|   Infusion reactions may happen during the infusion of this||
1996|066|H|drug. Tell your doctor right away if you have any symptoms of||
1996|067|H|infusion reactions such as low back or arm/leg pain, abdominal||
1996|068|H|pain, shaking, tiredness, bad taste in mouth, drowsiness, or||
1996|069|H|feeling faint. Your doctor may give you other medications to help||
1996|070|H|with these side effects or may stop your treatment for some time.||
1996|071|H|   Do not stop using this medication without consulting your||
1996|072|H|doctor. Your condition may become worse when the drug is stopped.||
1996|073|H|If you do stop using this medication, your doctor will monitor||
1996|074|H|you for at least 16 weeks to make sure your condition does not||
1996|075|H|get worse. Consult your doctor for more details.||
1996|076|H|   Tell your doctor if your condition does not get better or if||
1996|077|H|it gets worse.||
1996|078|B|||
1996|079|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
1996|080|S|   Headache, nausea, diarrhea, dizziness, or muscle/joint pain||
1996|081|S|may occur. If any of these effects last or get worse, tell your||
1996|082|S|doctor or pharmacist promptly.||
1996|083|S|   Remember that this medication has been prescribed because your||
1996|084|S|doctor has judged that the benefit to you is greater than the||
1996|085|S|risk of side effects. Many people using this medication do not||
1996|086|S|have serious side effects.||
1996|087|S|   This medication may lower your ability to fight infections.||
1996|088|S|This may make you more likely to get a serious (rarely fatal)||
1996|089|S|infection or make any infection you have worse. Tell your doctor||
1996|090|S|right away if you have any signs of infection (such as sore||
1996|091|S|throat that doesn't go away, fever, chills).||
1996|092|S|   If you have used a similar medication recently (C5 inhibitors||
1996|093|S|such as crovalimab, eculizumab), you may be at increased risk for||
1996|094|S|other immune system problems. Tell your doctor right away if you||
1996|095|S|have symptoms such as: bone pain, numbness/tingling of the||
1996|096|S|hands/feet, unusual tiredness/weakness, stomach/abdominal pain.||
1996|097|S|   A very serious allergic reaction to this drug is rare.||
1996|098|S|However, get medical help right away if you notice any symptoms||
1996|099|S|of a serious allergic reaction, including: rash, itching/swelling||
1996|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1996|101|S|breathing.||
1996|102|S|   This is not a complete list of possible side effects. If you||
1996|103|S|notice other effects not listed above, contact your doctor or||
1996|104|S|pharmacist.||
1996|105|S|   In the US -||
1996|106|S|   Call your doctor for medical advice about side effects. You||
1996|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1996|108|S|www.fda.gov/medwatch.||
1996|109|S|   In Canada - Call your doctor for medical advice about side||
1996|110|S|effects. You may report side effects to Health Canada at||
1996|111|S|1-866-234-2345.||
1996|112|B|||
1996|113|P|PRECAUTIONS:  Before using ravulizumab, tell your doctor or||
1996|114|P|pharmacist if you are allergic to it; or if you have any other||
1996|115|P|allergies. This product may contain inactive ingredients, which||
1996|116|P|can cause allergic reactions or other problems. Talk to your||
1996|117|P|pharmacist for more details.||
1996|118|P|   Before using this medication, tell your doctor or pharmacist||
1996|119|P|your medical history, especially of: current/recent infection.||
1996|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
1996|121|P|can make you more dizzy. Do not drive, use machinery, or do||
1996|122|P|anything that needs alertness until you can do it safely. Limit||
1996|123|P|alcoholic beverages. Talk to your doctor if you are using||
1996|124|P|marijuana (cannabis).||
1996|125|P|   Ravulizumab can make you more likely to get certain infections||
1996|126|P|(such as flu, colds, meningitis). Talk to your doctor for more||
1996|127|P|details.||
1996|128|P|   Tell your doctor your vaccine history and ask if you need to||
1996|129|P|get any vaccines before starting treatment with this medication.||
1996|130|P|Tell your health care professional that you are using ravulizumab||
1996|131|P|before having any immunizations/vaccinations. Avoid contact with||
1996|132|P|people who have recently received live vaccines (such as flu||
1996|133|P|vaccine inhaled through the nose).||
1996|134|P|   Before having surgery, tell your doctor or dentist about all||
1996|135|P|the products you use (including prescription drugs,||
1996|136|P|nonprescription drugs, and herbal products).||
1996|137|P|   During pregnancy, this medication should be used only when||
1996|138|P|clearly needed. Discuss the risks and benefits with your doctor.||
1996|139|P|   It is unknown if this drug passes into breast milk. Because of||
1996|140|P|the possible risk to the infant, breastfeeding is not recommended||
1996|141|P|while using this drug and for 8 months after the last dose.||
1996|142|P|Consult your doctor before breastfeeding.||
1996|143|B|||
1996|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1996|145|I|medications work or increase your risk for serious side effects.||
1996|146|I|This document does not contain all possible drug interactions.||
1996|147|I|Keep a list of all the products you use (including||
1996|148|I|prescription/nonprescription drugs and herbal products) and share||
1996|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
1996|150|I|the dosage of any medicines without your doctor's approval.||
1996|151|B|||
1996|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1996|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1996|154|O|poison control center right away. US residents can call||
1996|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1996|156|B|||
1996|157|N|NOTES:  Lab and/or medical tests (such as LDH levels, complete||
1996|158|N|blood count) should be done while you are using this medication,||
1996|159|N|and for 4 to 12 months after stopping treatment, depending on||
1996|160|N|your condition. Keep all medical and lab appointments.||
1996|161|B|||
1996|162|D|MISSED DOSE:  It is important to get each dose of this medication||
1996|163|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1996|164|D|right away for a new dosing schedule.||
1996|165|B|||
1996|166|R|STORAGE:  Not applicable. This medication is given in a clinic||
1996|167|R|and will not be stored at home.||
1996|168|B|||
1996|169|M|MEDICAL ALERT:  Your condition can cause complications in a||
1996|170|M|medical emergency. For information about enrolling in MedicAlert,||
1996|171|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1996|172|B|||
1996|173|A|Information last revised April 2025.||
1996|174|A|Copyright(c) 2025 First Databank, Inc.||
1996|175|B|||
1997|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1997|002|Z|does NOT have all possible information about this product. This||
1997|003|Z|information does not assure that this product is safe, effective,||
1997|004|Z|or appropriate for you. This information is not individual||
1997|005|Z|medical advice and does not substitute for the advice of your||
1997|006|Z|health care professional. Always ask your health care||
1997|007|Z|professional for complete information about this product and your||
1997|008|Z|specific health needs.||
1997|009|B|||
1997|010|T|AMIFAMPRIDINE PHOSPHATE - ORAL||
1997|011|F|(AM-i-FAM-pri-deen FOS-fate)||
1997|012|B|||
1997|013|C|COMMON BRAND NAME(S): Firdapse||
1997|014|B|||
1997|015|U|USES:  Amifampridine phosphate is used to treat a certain||
1997|016|U|disorder that affects nerves and muscles (Lambert-Eaton||
1997|017|U|syndrome). This disorder causes your body's immune system to||
1997|018|U|attack healthy nerve cells, which results in muscle weakness. It||
1997|019|U|is not known exactly how this medication works, but it can help||
1997|020|U|lessen symptoms of muscle weakness and loss of movement caused by||
1997|021|U|Lambert-Eaton syndrome.||
1997|022|B|||
1997|023|H|HOW TO USE:  Read the Medication Guide provided by your||
1997|024|H|pharmacist before you start taking amifampridine phosphate and||
1997|025|H|each time you get a refill. If you have any questions, ask your||
1997|026|H|doctor or pharmacist.||
1997|027|H|   Take this medication by mouth with or without food as directed||
1997|028|H|by your doctor, usually 3 to 5 times daily. The dosage is based||
1997|029|H|on your medical condition and response to treatment. Children's||
1997|030|H|dosage is also based on weight. To reduce your risk of side||
1997|031|H|effects, your doctor may direct you to start this medication at a||
1997|032|H|low dose and gradually increase your dose. Follow your doctor's||
1997|033|H|instructions carefully.||
1997|034|H|   If you need a dose that doesn't match taking half and/or whole||
1997|035|H|tablets together, or have trouble swallowing tablets, or receive||
1997|036|H|medication through a feeding tube, you may make a liquid||
1997|037|H|suspension with this medication. Read and follow the||
1997|038|H|manufacturer's directions (Instructions for Use leaflet) to make||
1997|039|H|a suspension with the tablet(s) and sterile water. Ask your||
1997|040|H|doctor or pharmacist about what you need to make the suspension.||
1997|041|H|Place the required number of tablets in a container. Add 10||
1997|042|H|milliliters (2 teaspoonfuls) sterile water to the container for||
1997|043|H|each tablet. Do not use any other foods or liquids to mix this||
1997|044|H|medication. Wait 5 minutes, then shake the mixture well for 30||
1997|045|H|seconds. Shake the suspension well before measuring each dose.||
1997|046|H|Carefully measure the dose using a special measuring||
1997|047|H|device/spoon. Do not use a household spoon because you may not||
1997|048|H|get the correct dose. Refrigerate the suspension between doses.||
1997|049|H|Prepare fresh suspensions daily. Throw away any unused suspension||
1997|050|H|after 24 hours.||
1997|051|H|   Use this medication regularly to get the most benefit from it.||
1997|052|H|To help you remember, take it at the same times each day.||
1997|053|H|   Tell your doctor if your condition does not get better or if||
1997|054|H|it gets worse.||
1997|055|B|||
1997|056|S|SIDE EFFECTS:  Tingling around the mouth, tongue, face, fingers,||
1997|057|S|toes, and other body parts may occur. Cold symptoms (such as||
1997|058|S|stuffy/runny nose, cough, sore throat, fever, sneezing), nausea,||
1997|059|S|diarrhea, constipation, headache, stomach/back pain, muscle||
1997|060|S|spasms, or dizziness may also occur. If any of these effects last||
1997|061|S|or get worse, tell your doctor or pharmacist promptly.||
1997|062|S|   Remember that this medication has been prescribed because your||
1997|063|S|doctor has judged that the benefit to you is greater than the||
1997|064|S|risk of side effects. Many people using this medication do not||
1997|065|S|have serious side effects.||
1997|066|S|   This medication may raise your blood pressure. Check your||
1997|067|S|blood pressure regularly and tell your doctor if the results are||
1997|068|S|high.||
1997|069|S|   Tell your doctor right away if you have any serious side||
1997|070|S|effects, including: symptoms of liver damage (such as||
1997|071|S|nausea/vomiting that doesn't stop, loss of appetite,||
1997|072|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), vision||
1997|073|S|changes (such as decreased/blurred vision).||
1997|074|S|   Get medical help right away if you have any very serious side||
1997|075|S|effects, including: seizure.||
1997|076|S|   A very serious allergic reaction to this drug is rare.||
1997|077|S|However, get medical help right away if you notice any symptoms||
1997|078|S|of a serious allergic reaction, including: rash, itching/swelling||
1997|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1997|080|S|breathing.||
1997|081|S|   This is not a complete list of possible side effects. If you||
1997|082|S|notice other effects not listed above, contact your doctor or||
1997|083|S|pharmacist.||
1997|084|S|   In the US -||
1997|085|S|   Call your doctor for medical advice about side effects. You||
1997|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1997|087|S|www.fda.gov/medwatch.||
1997|088|S|   In Canada - Call your doctor for medical advice about side||
1997|089|S|effects. You may report side effects to Health Canada at||
1997|090|S|1-866-234-2345.||
1997|091|B|||
1997|092|P|PRECAUTIONS:  Before taking amifampridine phosphate, tell your||
1997|093|P|doctor or pharmacist if you are allergic to it; or to||
1997|094|P|amifampridine; or if you have any other allergies. This product||
1997|095|P|may contain inactive ingredients, which can cause allergic||
1997|096|P|reactions or other problems. Talk to your pharmacist for more||
1997|097|P|details.||
1997|098|P|   Before using this medication, tell your doctor or pharmacist||
1997|099|P|your medical history, especially of: kidney problems, liver||
1997|100|P|problems, seizure.||
1997|101|P|   This drug may make you dizzy. Alcohol or marijuana can make||
1997|102|P|you more dizzy. Do not drive, use machinery, or do anything that||
1997|103|P|needs alertness until you can do it safely. Limit alcoholic||
1997|104|P|beverages. Talk to your doctor if you are using marijuana.||
1997|105|P|   Before having surgery, tell your doctor or dentist about all||
1997|106|P|the products you use (including prescription drugs,||
1997|107|P|nonprescription drugs, and herbal products).||
1997|108|P|   During pregnancy, this medication should be used only when||
1997|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
1997|110|P|   It is unknown if this medication passes into breast milk.||
1997|111|P|Consult your doctor before breastfeeding.||
1997|112|B|||
1997|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1997|114|I|medications work or increase your risk for serious side effects.||
1997|115|I|This document does not contain all possible drug interactions.||
1997|116|I|Keep a list of all the products you use (including||
1997|117|I|prescription/nonprescription drugs and herbal products) and share||
1997|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
1997|119|I|the dosage of any medicines without your doctor's approval.||
1997|120|I|   Amifampridine phosphate is very similar to amifampridine. Do||
1997|121|I|not switch brands unless directed by your doctor.||
1997|122|B|||
1997|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1997|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1997|125|O|poison control center right away. US residents can call||
1997|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1997|127|O|Symptoms of overdose may include: severe dizziness,||
1997|128|O|fast/irregular heartbeat, fainting.||
1997|129|B|||
1997|130|N|NOTES:  Do not share this medication with others.||
1997|131|B|||
1997|132|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
1997|133|D|remember. If it is near the time of the next dose, skip the||
1997|134|D|missed dose. Take your next dose at the regular time. Do not||
1997|135|D|double the dose to catch up.||
1997|136|B|||
1997|137|R|STORAGE:  Store the tablets at room temperature away from light||
1997|138|R|and moisture. Do not store in the bathroom. Keep all medications||
1997|139|R|away from children and pets.||
1997|140|R|   If you are using the liquid suspension, store it in the||
1997|141|R|refrigerator. After mixing, discard any unused suspension after||
1997|142|R|24 hours. (See also How to Use section.)||
1997|143|R|   Do not flush medications down the toilet or pour them into a||
1997|144|R|drain unless instructed to do so. Properly discard this product||
1997|145|R|when it is expired or no longer needed. Consult your pharmacist||
1997|146|R|or local waste disposal company.||
1997|147|B|||
1997|148|A|Information last revised August 2024.||
1997|149|A|Copyright(c) 2025 First Databank, Inc.||
1997|150|B|||
1998|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1998|002|Z|does NOT have all possible information about this product. This||
1998|003|Z|information does not assure that this product is safe, effective,||
1998|004|Z|or appropriate for you. This information is not individual||
1998|005|Z|medical advice and does not substitute for the advice of your||
1998|006|Z|health care professional. Always ask your health care||
1998|007|Z|professional for complete information about this product and your||
1998|008|Z|specific health needs.||
1998|009|B|||
1998|010|T|EMAPALUMAB - INJECTION||
1998|011|F|(EM-a-PAL-ue-mab)||
1998|012|B|||
1998|013|C|COMMON BRAND NAME(S): Gamifant||
1998|014|B|||
1998|015|U|USES:  This medication is used to treat certain immune system||
1998|016|U|problems (hemophagocytic lymphohistiocytosis - HLH, macrophage||
1998|017|U|activation syndrome - MAS).||
1998|018|B|||
1998|019|H|HOW TO USE:  Read the Medication Guide provided by your||
1998|020|H|pharmacist before you start using emapalumab and each time you||
1998|021|H|receive an injection. If you have any questions, ask your doctor||
1998|022|H|or pharmacist.||
1998|023|H|   This medication is given by injection into a vein by a health||
1998|024|H|care professional. It is given as directed by your doctor,||
1998|025|H|usually over 1 hour. It is usually given twice a week (once every||
1998|026|H|3 to 4 days). The dosage is based on your medical condition,||
1998|027|H|weight, and response to treatment.||
1998|028|H|   Infusion reactions may happen during the infusion of this||
1998|029|H|drug. Tell your doctor right away if you have any symptoms of||
1998|030|H|infusion reactions such as flushing, fever, rash, headache, bone||
1998|031|H|pain, numbness/tingling, cold hands/feet, or excessive sweating.||
1998|032|H|Your doctor may slow down or stop your treatment for some time.||
1998|033|H|   Use this medication regularly to get the most benefit from it.||
1998|034|H|To help you remember, mark your calendar with a reminder.||
1998|035|B|||
1998|036|S|SIDE EFFECTS:  See also How to Use section.||
1998|037|S|   Remember that this medication has been prescribed because your||
1998|038|S|doctor has judged that the benefit to you is greater than the||
1998|039|S|risk of side effects. Many people using this medication do not||
1998|040|S|have serious side effects.||
1998|041|S|   This medication may lower your ability to fight infections.||
1998|042|S|This may make you more likely to get a serious (rarely fatal)||
1998|043|S|infection or make any infection you have worse. Tell your doctor||
1998|044|S|right away if you have any signs of infection (such as sore||
1998|045|S|throat that doesn't go away, fever, chills).||
1998|046|S|   This medication may raise your blood pressure. Check your||
1998|047|S|blood pressure regularly and tell your doctor if the results are||
1998|048|S|high.||
1998|049|S|   A very serious allergic reaction to this drug is rare.||
1998|050|S|However, get medical help right away if you notice any symptoms||
1998|051|S|of a serious allergic reaction, including: rash, itching/swelling||
1998|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1998|053|S|breathing.||
1998|054|S|   This is not a complete list of possible side effects. If you||
1998|055|S|notice other effects not listed above, contact your doctor or||
1998|056|S|pharmacist.||
1998|057|S|   In the US -||
1998|058|S|   Call your doctor for medical advice about side effects. You||
1998|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1998|060|S|www.fda.gov/medwatch.||
1998|061|S|   In Canada - Call your doctor for medical advice about side||
1998|062|S|effects. You may report side effects to Health Canada at||
1998|063|S|1-866-234-2345.||
1998|064|B|||
1998|065|P|PRECAUTIONS:  Before using emapalumab, tell your doctor or||
1998|066|P|pharmacist if you are allergic to it; or if you have any other||
1998|067|P|allergies. This product may contain inactive ingredients, which||
1998|068|P|can cause allergic reactions or other problems. Talk to your||
1998|069|P|pharmacist for more details.||
1998|070|P|   Before using this medication, tell your doctor or pharmacist||
1998|071|P|your medical history, especially of: current/recent/returning||
1998|072|P|infection (such as herpes zoster and tuberculosis).||
1998|073|P|   Before starting this medication, you should take a||
1998|074|P|tuberculosis (TB) skin test to check for a type of tuberculosis||
1998|075|P|that may not be causing any symptoms (latent TB). If you are||
1998|076|P|diagnosed with TB, you must first be treated for it before you||
1998|077|P|start emapalumab to prevent a serious TB infection.||
1998|078|P|   Emapalumab can make you more likely to get infections or may||
1998|079|P|make current infections worse. Stay away from anyone who has an||
1998|080|P|infection that may easily spread (such as chickenpox, COVID-19,||
1998|081|P|measles, flu). Talk to your doctor if you have been exposed to an||
1998|082|P|infection or for more details.||
1998|083|P|   Tell your doctor your vaccine history and ask if you need to||
1998|084|P|get any vaccines before starting treatment with this medication.||
1998|085|P|Tell your health care professional that you are using emapalumab||
1998|086|P|before having any immunizations/vaccinations. Avoid getting a||
1998|087|P|live vaccine for 4 weeks after the last dose of this medication.||
1998|088|P|Avoid contact with people who have recently received live||
1998|089|P|vaccines (such as flu vaccine inhaled through the nose).||
1998|090|P|   Before having surgery, tell your doctor or dentist about all||
1998|091|P|the products you use (including prescription drugs,||
1998|092|P|nonprescription drugs, and herbal products).||
1998|093|P|   During pregnancy, this medication should be used only when||
1998|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
1998|095|P|   It is unknown if this medication passes into breast milk.||
1998|096|P|Consult your doctor before breastfeeding.||
1998|097|B|||
1998|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1998|099|I|medications work or increase your risk for serious side effects.||
1998|100|I|This document does not contain all possible drug interactions.||
1998|101|I|Keep a list of all the products you use (including||
1998|102|I|prescription/nonprescription drugs and herbal products) and share||
1998|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
1998|104|I|the dosage of any medicines without your doctor's approval.||
1998|105|B|||
1998|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1998|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1998|108|O|poison control center right away. US residents can call||
1998|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1998|110|B|||
1998|111|N|NOTES:  Do not share this medication with others.||
1998|112|N|   Lab and/or medical tests (such as complete blood count, PPD||
1998|113|N|test) should be done before you start using this medication and||
1998|114|N|while you are using it. Keep all medical and lab appointments.||
1998|115|N|Consult your doctor for more details.||
1998|116|B|||
1998|117|D|MISSED DOSE:  It is important to get each dose of this medication||
1998|118|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
1998|119|D|right away for a new dosing schedule.||
1998|120|B|||
1998|121|R|STORAGE:  Not applicable. This medication is given in a hospital||
1998|122|R|or clinic and will not be stored at home.||
1998|123|B|||
1998|124|M|MEDICAL ALERT:  Your condition can cause complications in a||
1998|125|M|medical emergency. For information about enrolling in MedicAlert,||
1998|126|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
1998|127|B|||
1998|128|A|Information last revised June 2025.||
1998|129|A|Copyright(c) 2025 First Databank, Inc.||
1998|130|B|||
1999|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
1999|002|Z|does NOT have all possible information about this product. This||
1999|003|Z|information does not assure that this product is safe, effective,||
1999|004|Z|or appropriate for you. This information is not individual||
1999|005|Z|medical advice and does not substitute for the advice of your||
1999|006|Z|health care professional. Always ask your health care||
1999|007|Z|professional for complete information about this product and your||
1999|008|Z|specific health needs.||
1999|009|B|||
1999|010|T|TAFENOQUINE 150 MILLIGRAM TABLET - ORAL||
1999|011|F|(ta-FEN-oh-kwin)||
1999|012|B|||
1999|013|C|COMMON BRAND NAME(S): Krintafel||
1999|014|B|||
1999|015|U|USES:  Tafenoquine is used in combination with another medication||
1999|016|U|(chloroquine) to prevent the return of malaria. Malaria is caused||
1999|017|U|by infection with a parasite spread by mosquito bite. After they||
1999|018|U|multiply and grow, the parasites infect your red blood cells and||
1999|019|U|cause symptoms of malaria (such as fever, chills, sweating,||
1999|020|U|headache, other flu-like symptoms). This medication works by||
1999|021|U|stopping the growth of the parasite that causes malaria.||
1999|022|B|||
1999|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
1999|024|H|from your pharmacist before you start taking tafenoquine and each||
1999|025|H|time you get a refill. If you have any questions, ask your doctor||
1999|026|H|or pharmacist.||
1999|027|H|   Take this medication by mouth with food as directed by your||
1999|028|H|doctor, usually a one-time dose taken on the first or second day||
1999|029|H|of treatment with other antimalarial medication (chloroquine).||
1999|030|H|The manufacturer directs to swallow this medication whole, and to||
1999|031|H|not break, crush, or chew the tablet before taking it. However,||
1999|032|H|many similar drugs (immediate-release tablets) can be split,||
1999|033|H|crushed, or chewed. Follow your doctor's directions on how to||
1999|034|H|take this medication.||
1999|035|H|   If you vomit within 1 hour after taking your dose, ask your||
1999|036|H|doctor if you should take another dose.||
1999|037|H|   No medication is completely effective in preventing the return||
1999|038|H|of malaria. Malaria treatment works best when it is started||
1999|039|H|early. Tell your doctor if your symptoms do not get better or if||
1999|040|H|they get worse.||
1999|041|B|||
1999|042|S|SIDE EFFECTS:  Tafenoquine stays in your body a long time, so||
1999|043|S|side effects may be delayed or last longer than expected.||
1999|044|S|   Trouble sleeping, anxiety, or nightmares may occur. If any of||
1999|045|S|these effects last or get worse, tell your doctor or pharmacist||
1999|046|S|promptly.||
1999|047|S|   Remember that this medication has been prescribed because your||
1999|048|S|doctor has judged that the benefit to you is greater than the||
1999|049|S|risk of side effects. Many people using this medication do not||
1999|050|S|have serious side effects.||
1999|051|S|   Tell your doctor right away if you have any serious side||
1999|052|S|effects, including: eye/vision problems.||
1999|053|S|   Get medical help right away if you have any very serious side||
1999|054|S|effects, including: mental/mood changes (such as hallucinations,||
1999|055|S|unusual thoughts/behavior, confusion), unusual tiredness, rapid||
1999|056|S|breathing, pale skin, shortness of breath, fast heartbeat,||
1999|057|S|dizziness/lightheadedness, bluish lips or skin, headache that||
1999|058|S|lasts or is severe, yellowing eyes/skin, dark urine.||
1999|059|S|   A very serious allergic reaction to this drug is rare.||
1999|060|S|However, get medical help right away if you notice any symptoms||
1999|061|S|of a serious allergic reaction, including: rash, itching/swelling||
1999|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
1999|063|S|breathing.||
1999|064|S|   This is not a complete list of possible side effects. If you||
1999|065|S|notice other effects not listed above, contact your doctor or||
1999|066|S|pharmacist.||
1999|067|S|   In the US -||
1999|068|S|   Call your doctor for medical advice about side effects. You||
1999|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
1999|070|S|www.fda.gov/medwatch.||
1999|071|S|   In Canada - Call your doctor for medical advice about side||
1999|072|S|effects. You may report side effects to Health Canada at||
1999|073|S|1-866-234-2345.||
1999|074|B|||
1999|075|P|PRECAUTIONS:  Before taking tafenoquine, tell your doctor or||
1999|076|P|pharmacist if you are allergic to it; or to chloroquine or||
1999|077|P|primaquine; or if you have any other allergies. This product may||
1999|078|P|contain inactive ingredients, which can cause allergic reactions||
1999|079|P|or other problems. Talk to your pharmacist for more details.||
1999|080|P|   Before using this medication, tell your doctor or pharmacist||
1999|081|P|your medical history, especially of: mental/mood disorders (such||
1999|082|P|as psychosis, schizophrenia, hallucinations, delusions,||
1999|083|P|disorganized thinking/behavior), certain enzyme deficiencies||
1999|084|P|(G6PD deficiency, NADH-dependent methemoglobin reductase||
1999|085|P|deficiency).||
1999|086|P|   Before having surgery, tell your doctor or dentist about all||
1999|087|P|the products you use (including prescription drugs,||
1999|088|P|nonprescription drugs, and herbal products).||
1999|089|P|   Tell your doctor if you are pregnant or plan to become||
1999|090|P|pregnant. You should not become pregnant while using tafenoquine.||
1999|091|P|Tafenoquine may harm an unborn baby. Your doctor should order a||
1999|092|P|pregnancy test before you start this medication. Ask about||
1999|093|P|reliable forms of birth control for 3 months after the dose. If||
1999|094|P|you become pregnant, talk to your doctor right away about the||
1999|095|P|risks and benefits of this medication.||
1999|096|P|   It is unknown if this medication passes into breast milk. A||
1999|097|P|blood test to check if your baby has G6PD deficiency should be||
1999|098|P|done before you start breastfeeding. If your baby is G6PD||
1999|099|P|deficient or if the G6PD status is unknown, breastfeeding is not||
1999|100|P|recommended for 3 months after the dose. Consult your doctor||
1999|101|P|before breastfeeding.||
1999|102|B|||
1999|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
1999|104|I|medications work or increase your risk for serious side effects.||
1999|105|I|This document does not contain all possible drug interactions.||
1999|106|I|Keep a list of all the products you use (including||
1999|107|I|prescription/nonprescription drugs and herbal products) and share||
1999|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
1999|109|I|the dosage of any medicines without your doctor's approval.||
1999|110|I|   This medication can slow down the removal of other medications||
1999|111|I|from your body, which may affect how they work. One example is||
1999|112|I|dofetilide, among others.||
1999|113|B|||
1999|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
1999|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
1999|116|O|poison control center right away. US residents can call||
1999|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
1999|118|B|||
1999|119|N|NOTES:  Do not share this medication with others.||
1999|120|N|   Lab and/or medical tests (such as G6PD deficiency) should be||
1999|121|N|done before you take this medication. Keep all medical and lab||
1999|122|N|appointments.||
1999|123|B|||
1999|124|D|MISSED DOSE:  Not applicable.||
1999|125|B|||
1999|126|R|STORAGE:  Store at room temperature away from light and moisture.||
1999|127|R|Do not store in the bathroom. Keep all medications away from||
1999|128|R|children and pets.||
1999|129|R|   Do not flush medications down the toilet or pour them into a||
1999|130|R|drain unless instructed to do so. Properly discard this product||
1999|131|R|when it is expired or no longer needed. Consult your pharmacist||
1999|132|R|or local waste disposal company.||
1999|133|B|||
1999|134|A|Information last revised May 2024.||
1999|135|A|Copyright(c) 2025 First Databank, Inc.||
1999|136|B|||
2000|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2000|002|Z|does NOT have all possible information about this product. This||
2000|003|Z|information does not assure that this product is safe, effective,||
2000|004|Z|or appropriate for you. This information is not individual||
2000|005|Z|medical advice and does not substitute for the advice of your||
2000|006|Z|health care professional. Always ask your health care||
2000|007|Z|professional for complete information about this product and your||
2000|008|Z|specific health needs.||
2000|009|B|||
2000|010|T|MESALAMINE (5-AMINOSALICYLIC ACID) FOAM - RECTAL||
2000|011|F|(me-SAL-a-meen)||
2000|012|B|||
2000|013|U|USES:  Mesalamine (also known as 5-aminosalicylic acid or||
2000|014|U|mesalazine) is used to treat certain types of bowel disease||
2000|015|U|(ulcerative colitis, proctosigmoiditis, proctitis). It does not||
2000|016|U|cure these conditions, but it may help relieve discomfort/pain||
2000|017|U|and lessen how often you have diarrhea or bloody stools.||
2000|018|U|Mesalamine is an aminosalicylate anti-inflammatory drug. It works||
2000|019|U|by blocking the production of certain natural substances that||
2000|020|U|cause inflammation. This effect helps to decrease pain and||
2000|021|U|swelling.||
2000|022|B|||
2000|023|V|OTHER USES:  This section contains uses of this drug that are not||
2000|024|V|listed in the approved professional labeling for the drug but||
2000|025|V|that may be prescribed by your health care professional. Use this||
2000|026|V|drug for a condition that is listed in this section only if it||
2000|027|V|has been so prescribed by your health care professional.||
2000|028|V|   This drug may also be used for Crohn's disease.||
2000|029|B|||
2000|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2000|031|H|from your pharmacist before you start using mesalamine and each||
2000|032|H|time you get a refill. If you have any questions, ask your doctor||
2000|033|H|or pharmacist.||
2000|034|H|   Use this medication rectally as directed by your doctor,||
2000|035|H|usually once daily at bedtime. The dosage is based on your||
2000|036|H|medical condition and response to treatment.||
2000|037|H|   Drink plenty of fluids during treatment with this medication||
2000|038|H|unless otherwise directed by your doctor. This will help prevent||
2000|039|H|kidney stones.||
2000|040|H|   If possible, go to the toilet and have a bowel movement before||
2000|041|H|using this medication. Push the single-use applicator firmly onto||
2000|042|H|the spout of the spray can. Shake the spray can well for 20||
2000|043|H|seconds. Remove the safety tab, then twist the dome top as||
2000|044|H|directed. Turn the can upside down. Place one foot on a chair or||
2000|045|H|stool and gently insert the applicator into your rectum. Using||
2000|046|H|your index finger, push down fully on the pump dome, then slowly||
2000|047|H|release it. Wait 10 to 15 seconds for the foam to be delivered.||
2000|048|H|Repeat for a second spray and wait another 10 to 15 seconds.||
2000|049|H|Remove the applicator and dispose of it in the provided plastic||
2000|050|H|bag. Wash your hands and try not to empty your bowels until the||
2000|051|H|next morning.||
2000|052|H|   If you have trouble keeping in 2 sprays of foam at one time,||
2000|053|H|you may separate the times you use it (for example, one spray at||
2000|054|H|bedtime and another spray during the night or early in the||
2000|055|H|morning). Ask your doctor or pharmacist for specific directions.||
2000|056|H|   Use this medication regularly to get the most benefit from it.||
2000|057|H|To help you remember, use it at the same time each day.||
2000|058|H|   Tell your doctor if your condition does not get better or if||
2000|059|H|it gets worse.||
2000|060|B|||
2000|061|S|SIDE EFFECTS:  Rectal pain, abdominal pain, gas, headache,||
2000|062|S|diarrhea, or constipation may occur. If any of these effects last||
2000|063|S|or get worse, tell your doctor or pharmacist promptly.||
2000|064|S|   Remember that this medication has been prescribed because your||
2000|065|S|doctor has judged that the benefit to you is greater than the||
2000|066|S|risk of side effects. Many people using this medication do not||
2000|067|S|have serious side effects.||
2000|068|S|   Rarely, this medication may make your symptoms worse instead||
2000|069|S|of better. Tell your doctor right away if you have any of these||
2000|070|S|side effects: worsening stomach pain/cramping, worsening bloody||
2000|071|S|diarrhea, headache that doesn't go away.||
2000|072|S|   Tell your doctor right away if you have any serious side||
2000|073|S|effects, including: chest pain, shortness of breath, severe||
2000|074|S|stomach/abdominal pain (especially if spreading to the back),||
2000|075|S|yellowing eyes/skin, dark urine, signs of kidney problems (such||
2000|076|S|as change in the amount of urine, blood in the urine).||
2000|077|S|   A very serious allergic reaction to this drug is rare.||
2000|078|S|However, get medical help right away if you notice any symptoms||
2000|079|S|of a serious allergic reaction, including: fever, swollen lymph||
2000|080|S|nodes, rash, itching/swelling (especially of the||
2000|081|S|face/tongue/throat), severe dizziness, trouble breathing.||
2000|082|S|   This is not a complete list of possible side effects. If you||
2000|083|S|notice other effects not listed above, contact your doctor or||
2000|084|S|pharmacist.||
2000|085|S|   In the US -||
2000|086|S|   Call your doctor for medical advice about side effects. You||
2000|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2000|088|S|www.fda.gov/medwatch.||
2000|089|S|   In Canada - Call your doctor for medical advice about side||
2000|090|S|effects. You may report side effects to Health Canada at||
2000|091|S|1-866-234-2345.||
2000|092|B|||
2000|093|P|PRECAUTIONS:  Before using mesalamine, tell your doctor or||
2000|094|P|pharmacist if you are allergic to it; or to other||
2000|095|P|aminosalicylates (such as balsalazide, olsalazine); or to||
2000|096|P|salicylates (such as aspirin, salsalate); or to sulfasalazine; or||
2000|097|P|if you have any other allergies. This product may contain||
2000|098|P|inactive ingredients, which can cause allergic reactions or other||
2000|099|P|problems. Talk to your pharmacist for more details.||
2000|100|P|   Before using this medication, tell your doctor or pharmacist||
2000|101|P|your medical history, especially of: asthma, kidney problems,||
2000|102|P|liver disease, pancreas problems (pancreatitis), inflammation of||
2000|103|P|the sac around the heart (pericarditis).||
2000|104|P|   This medication may make you more sensitive to the sun,||
2000|105|P|especially if you have skin problems (such as atopic dermatitis,||
2000|106|P|eczema). Limit your time in the sun. Avoid tanning booths and||
2000|107|P|sunlamps. Use sunscreen and wear protective clothing when||
2000|108|P|outdoors. Tell your doctor right away if you get sunburned or||
2000|109|P|have skin blisters/redness.||
2000|110|P|   Before having surgery, tell your doctor or dentist about all||
2000|111|P|the products you use (including prescription drugs,||
2000|112|P|nonprescription drugs, and herbal products).||
2000|113|P|   This medication is similar to aspirin. Children and teenagers||
2000|114|P|younger than 18 years should not take aspirin or aspirin-related||
2000|115|P|medications (such as salicylates) if they have chickenpox, flu,||
2000|116|P|or any undiagnosed illness, or if they have just been given a||
2000|117|P|live virus vaccine (such as varicella vaccine), without first||
2000|118|P|consulting a doctor about Reye's syndrome, a rare but serious||
2000|119|P|illness.||
2000|120|P|   During pregnancy, this medication should be used only when||
2000|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
2000|122|P|   This medication passes into breast milk and may have||
2000|123|P|undesirable effects on a nursing infant. Consult your doctor||
2000|124|P|before breastfeeding.||
2000|125|B|||
2000|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2000|127|I|medications work or increase your risk for serious side effects.||
2000|128|I|This document does not contain all possible drug interactions.||
2000|129|I|Keep a list of all the products you use (such as||
2000|130|I|prescription/nonprescription drugs and herbal products) and share||
2000|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
2000|132|I|the dosage of any medicines without your doctor's approval.||
2000|133|I|   This medication may interfere with certain lab tests||
2000|134|I|(including urine normetanephrine levels), possibly causing false||
2000|135|I|test results. Make sure lab personnel and all your doctors know||
2000|136|I|you use this drug.||
2000|137|B|||
2000|138|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2000|139|O|has overdosed and has serious symptoms such as passing out or||
2000|140|O|trouble breathing, call 911. Otherwise, call a poison control||
2000|141|O|center right away. US residents can call 1-800-222-1222. Canada||
2000|142|O|residents can call 1-844-764-7669.||
2000|143|B|||
2000|144|N|NOTES:  Do not share this medication with others.||
2000|145|N|   Lab and/or medical tests (such as liver/kidney function) may||
2000|146|N|be done before you start using this medication and while you are||
2000|147|N|using it. Keep all medical and lab appointments. Consult your||
2000|148|N|doctor for more details.||
2000|149|B|||
2000|150|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2000|151|D|If it is near the time of the next dose, skip the missed dose.||
2000|152|D|Use your next dose at the regular time. Do not double the dose to||
2000|153|D|catch up.||
2000|154|B|||
2000|155|R|STORAGE:  Store at room temperature away from sources of heat||
2000|156|R|(such as near radiators/stoves). Do not refrigerate or freeze.||
2000|157|R|Discard 12 weeks after first use. Keep all medications away from||
2000|158|R|children and pets.||
2000|159|R|   Do not flush medications down the toilet or pour them into a||
2000|160|R|drain unless instructed to do so. Properly discard this product||
2000|161|R|when it is expired or no longer needed. Consult your pharmacist||
2000|162|R|or local waste disposal company.||
2000|163|B|||
2000|164|A|Information last revised September 2024.||
2000|165|A|Copyright(c) 2025 First Databank, Inc.||
2000|166|B|||
2002|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2002|002|Z|does NOT have all possible information about this product. This||
2002|003|Z|information does not assure that this product is safe, effective,||
2002|004|Z|or appropriate for you. This information is not individual||
2002|005|Z|medical advice and does not substitute for the advice of your||
2002|006|Z|health care professional. Always ask your health care||
2002|007|Z|professional for complete information about this product and your||
2002|008|Z|specific health needs.||
2002|009|B|||
2002|010|T|LIDOCAINE/TETRACAINE - TOPICAL||
2002|011|F|(LYE-doe-kane/TET-ra-kane)||
2002|012|B|||
2002|013|C|COMMON BRAND NAME(S): Pliaglis||
2002|014|B|||
2002|015|U|USES:  This product contains 2 ingredients: lidocaine and||
2002|016|U|tetracaine. Lidocaine and tetracaine both belong to a class of||
2002|017|U|drugs known as local anesthetics. This product is used on the||
2002|018|U|skin to prevent pain before certain procedures (such as dermal||
2002|019|U|filler injection, facial laser resurfacing, laser-assisted tattoo||
2002|020|U|removal). It works by briefly numbing the skin and surrounding||
2002|021|U|area.||
2002|022|U|   This product is not for use on mucous membranes.||
2002|023|B|||
2002|024|H|HOW TO USE:  Do not use on large areas of the body, cover the||
2002|025|H|area with waterproof bandages or plastic, or apply heat unless||
2002|026|H|directed to do so by your doctor. These may increase the risk of||
2002|027|H|serious side effects.||
2002|028|H|   After applying, wash your hands right away unless you are||
2002|029|H|treating an area on the hands. Avoid getting the product in your||
2002|030|H|eyes, nose, or ears. If the medication gets in these areas, rinse||
2002|031|H|the area right away with clean water.||
2002|032|H|   The dosage is based on your medical condition and response to||
2002|033|H|treatment. Do not use more of this product, use it more often, or||
2002|034|H|use it longer than prescribed by your doctor. Do not use on areas||
2002|035|H|of skin that are broken, irritated, or infected.||
2002|036|B|||
2002|037|S|SIDE EFFECTS:  Temporary redness, stinging, change in skin color,||
2002|038|S|or swelling may occur at the application site. If any of these||
2002|039|S|effects last or get worse, tell your doctor or pharmacist||
2002|040|S|promptly.||
2002|041|S|   Remember that this medication has been prescribed because your||
2002|042|S|doctor has judged that the benefit to you is greater than the||
2002|043|S|risk of side effects. Many people using this medication do not||
2002|044|S|have serious side effects.||
2002|045|S|   Get medical help right away if you have any very serious side||
2002|046|S|effects, including: pale/bluish/gray skin, unusual tiredness,||
2002|047|S|shortness of breath, slow/shallow breathing, fast/slow/irregular||
2002|048|S|heartbeat, seizure.||
2002|049|S|   A very serious allergic reaction to this drug is rare.||
2002|050|S|However, get medical help right away if you notice any symptoms||
2002|051|S|of a serious allergic reaction, including: rash, itching/swelling||
2002|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2002|053|S|breathing.||
2002|054|S|   This is not a complete list of possible side effects. If you||
2002|055|S|notice any other effects not listed above, contact your doctor or||
2002|056|S|pharmacist.||
2002|057|S|   In the US -||
2002|058|S|   Call your doctor for medical advice about side effects. You||
2002|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2002|060|S|www.fda.gov/medwatch.||
2002|061|S|   In Canada - Call your doctor for medical advice about side||
2002|062|S|effects. You may report side effects to Health Canada at||
2002|063|S|1-866-234-2345.||
2002|064|B|||
2002|065|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2002|066|P|pharmacist if you are allergic to lidocaine or tetracaine; or to||
2002|067|P|other amide-type anesthetics (such as bupivacaine, prilocaine);||
2002|068|P|or if you have any other allergies. This product may contain||
2002|069|P|inactive ingredients, which can cause allergic reactions or other||
2002|070|P|problems. Talk to your pharmacist for more details.||
2002|071|P|   Before using this medication, tell your doctor or pharmacist||
2002|072|P|your medical history, especially of: heart problems, liver||
2002|073|P|disease, a certain blood disorder (methemoglobinemia), breathing||
2002|074|P|problems (such as asthma, bronchitis, emphysema), smoking||
2002|075|P|history.||
2002|076|P|   Before having surgery, tell your doctor or dentist about all||
2002|077|P|the products you use (including prescription drugs,||
2002|078|P|nonprescription drugs, and herbal products).||
2002|079|P|   Children may be more sensitive to the side effects of this||
2002|080|P|drug.||
2002|081|P|   During pregnancy, this medication should be used only when||
2002|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
2002|083|P|   Lidocaine passes into breast milk in small amounts, but is||
2002|084|P|unlikely to harm a nursing infant. It is unknown if tetracaine||
2002|085|P|passes into breast milk. Consult your doctor before||
2002|086|P|breastfeeding.||
2002|087|B|||
2002|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2002|089|I|medications work or increase your risk for serious side effects.||
2002|090|I|This document does not contain all possible drug interactions.||
2002|091|I|Keep a list of all the products you use (including||
2002|092|I|prescription/nonprescription drugs and herbal products) and share||
2002|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
2002|094|I|the dosage of any medicines without your doctor's approval.||
2002|095|B|||
2002|096|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2002|097|O|has overdosed and has serious symptoms such as passing out or||
2002|098|O|trouble breathing, call 911. Otherwise, call a poison control||
2002|099|O|center right away. US residents can call 1-800-222-1222. Canada||
2002|100|O|residents can call 1-844-764-7669. Symptoms of overdose may||
2002|101|O|include: drowsiness, irregular heartbeat, seizure.||
2002|102|B|||
2002|103|N|NOTES:  Do not share this medication with others.||
2002|104|B|||
2002|105|D|MISSED DOSE:  Not applicable.||
2002|106|B|||
2002|107|R|STORAGE:  Store in the refrigerator. Do not freeze. This||
2002|108|R|medication may also be stored at room temperature if needed. If||
2002|109|R|the medication is stored at room temperature, discard after 3||
2002|110|R|months. Keep all medications away from children and pets.||
2002|111|R|   Do not flush medications down the toilet or pour them into a||
2002|112|R|drain unless instructed to do so. Properly discard this product||
2002|113|R|when it is expired or no longer needed. Consult your pharmacist||
2002|114|R|or local waste disposal company.||
2002|115|B|||
2002|116|A|Information last revised September 2024.||
2002|117|A|Copyright(c) 2025 First Databank, Inc.||
2002|118|B|||
2004|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2004|002|Z|does NOT have all possible information about this product. This||
2004|003|Z|information does not assure that this product is safe, effective,||
2004|004|Z|or appropriate for you. This information is not individual||
2004|005|Z|medical advice and does not substitute for the advice of your||
2004|006|Z|health care professional. Always ask your health care||
2004|007|Z|professional for complete information about this product and your||
2004|008|Z|specific health needs.||
2004|009|B|||
2004|010|T|SCOPOLAMINE (HYOSCINE) BUTYLBROMIDE - ORAL||
2004|011|F|(skoe-POL-a-meen HI-oh-seen BYOU-tull-BROH-mide)||
2004|012|B|||
2004|013|U|USES:  Scopolamine (also known as hyoscine) is used to treat||
2004|014|U|cramps (spasms) of the stomach, intestines, kidney, and bladder.||
2004|015|U|It helps to relieve discomfort caused by conditions such as||
2004|016|U|irritable bowel syndrome, gallstones, kidney stones, and||
2004|017|U|overactive/spastic bladder. It works by slowing down the natural||
2004|018|U|movements of the gut and by relaxing the muscles in these parts||
2004|019|U|of the body. This medication is a belladonna alkaloid. It belongs||
2004|020|U|to the class of drugs known as antispasmodics.||
2004|021|B|||
2004|022|H|HOW TO USE:  Take this medication by mouth as directed by your||
2004|023|H|doctor. The dosage is based on your medical condition and||
2004|024|H|response to treatment. Do not increase your dose or take it more||
2004|025|H|often than prescribed without consulting your doctor. Do not take||
2004|026|H|more than 60 milligrams of this medication a day.||
2004|027|H|   Swallow the tablets whole with a glass of water. Drink plenty||
2004|028|H|of fluids while you are taking this medication unless your doctor||
2004|029|H|directs you otherwise.||
2004|030|H|   Antacids and certain anti-diarrhea drugs (adsorbent-type drugs||
2004|031|H|such as kaolin-pectin, attapulgite) lower the absorption of||
2004|032|H|scopolamine. If you also take these medications, take scopolamine||
2004|033|H|at least 1 hour before taking them.||
2004|034|H|   Tell your doctor if your condition lasts or gets worse.||
2004|035|B|||
2004|036|S|SIDE EFFECTS:  Dry mouth, nausea, decreased sweating, flushing,||
2004|037|S|blurred vision, constipation, dizziness, or drowsiness may occur.||
2004|038|S|If any of these effects last or get worse, tell your doctor or||
2004|039|S|pharmacist promptly.||
2004|040|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
2004|041|S|chips, chew (sugarless) gum, drink water, or use a saliva||
2004|042|S|substitute.||
2004|043|S|   Remember that this medication has been prescribed because your||
2004|044|S|doctor has judged that the benefit to you is greater than the||
2004|045|S|risk of side effects. Many people using this medication do not||
2004|046|S|have serious side effects.||
2004|047|S|   Tell your doctor right away if you have any serious side||
2004|048|S|effects, including: shortness of breath, trouble urinating,||
2004|049|S|fast/irregular heartbeat, mental/mood changes (such as||
2004|050|S|confusion).||
2004|051|S|   This medication may increase the pressure inside the eyes of||
2004|052|S|people with a certain type of eye disease (narrow-angle glaucoma)||
2004|053|S|or those at risk for it. Get medical help right away if any of||
2004|054|S|these serious side effects occur: vision problems (such as loss||
2004|055|S|of vision), eye pain.||
2004|056|S|   A very serious allergic reaction to this drug is rare.||
2004|057|S|However, get medical help right away if you notice any symptoms||
2004|058|S|of a serious allergic reaction, including: rash, itching/swelling||
2004|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2004|060|S|breathing.||
2004|061|S|   This is not a complete list of possible side effects. If you||
2004|062|S|notice other effects not listed above, contact your doctor or||
2004|063|S|pharmacist.||
2004|064|S|   In the US -||
2004|065|S|   Call your doctor for medical advice about side effects. You||
2004|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2004|067|S|www.fda.gov/medwatch.||
2004|068|S|   In Canada - Call your doctor for medical advice about side||
2004|069|S|effects. You may report side effects to Health Canada at||
2004|070|S|1-866-234-2345.||
2004|071|B|||
2004|072|P|PRECAUTIONS:  Before taking scopolamine, tell your doctor or||
2004|073|P|pharmacist if you are allergic to it; or to other belladonna||
2004|074|P|alkaloids (such as atropine, hyoscyamine); or if you have any||
2004|075|P|other allergies. This product may contain inactive ingredients,||
2004|076|P|which can cause allergic reactions or other problems. Talk to||
2004|077|P|your pharmacist for more details.||
2004|078|P|   Before using this medication, tell your doctor or pharmacist||
2004|079|P|your medical history, especially of: glaucoma, myasthenia gravis,||
2004|080|P|trouble urinating (for example, due to enlarged prostate), heart||
2004|081|P|problems (such as fast heartbeat, abnormal heart rhythm, heart||
2004|082|P|failure, coronary artery disease, angina, mitral stenosis), other||
2004|083|P|stomach/intestinal problems (such as slow gut, blockage,||
2004|084|P|megacolon, infection, ulcerative colitis), high blood pressure,||
2004|085|P|overactive thyroid (hyperthyroidism), heartburn problems (such as||
2004|086|P|acid reflux, hiatal hernia), kidney disease, liver disease.||
2004|087|P|   This drug may make you dizzy or drowsy or blur your vision.||
2004|088|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
2004|089|P|drowsy. Do not drive, use machinery, or do anything that needs||
2004|090|P|alertness or clear vision until you can do it safely. Limit||
2004|091|P|alcoholic beverages. Talk to your doctor if you are using||
2004|092|P|marijuana (cannabis).||
2004|093|P|   This drug may make you sweat less, making you more likely to||
2004|094|P|get heat stroke. Avoid doing things that may cause you to||
2004|095|P|overheat, such as hard work or exercise in hot weather, or using||
2004|096|P|hot tubs. When the weather is hot, drink a lot of fluids and||
2004|097|P|dress lightly. If you overheat, quickly look for a place to cool||
2004|098|P|down and rest. Get medical help right away if you have a fever||
2004|099|P|that does not go away, mental/mood changes, headache, or||
2004|100|P|dizziness.||
2004|101|P|   Older adults may be more sensitive to the side effects of this||
2004|102|P|drug, especially dizziness, drowsiness, dry mouth, trouble||
2004|103|P|urinating, or eye problems.||
2004|104|P|   During pregnancy, this medication should be used only when||
2004|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
2004|106|P|   This drug passes into breast milk. Consult your doctor before||
2004|107|P|breastfeeding.||
2004|108|B|||
2004|109|I|DRUG INTERACTIONS:  See also How to Use section.||
2004|110|I|   Drug interactions may change how your medications work or||
2004|111|I|increase your risk for serious side effects. This document does||
2004|112|I|not contain all possible drug interactions. Keep a list of all||
2004|113|I|the products you use (including prescription/nonprescription||
2004|114|I|drugs and herbal products) and share it with your doctor and||
2004|115|I|pharmacist. Do not start, stop, or change the dosage of any||
2004|116|I|medicines without your doctor's approval.||
2004|117|I|   Some products that may interact with this drug include:||
2004|118|I|pramlintide, potassium tablets/capsules.||
2004|119|I|   Tell your doctor or pharmacist if you are taking other||
2004|120|I|products that cause drowsiness such as opioid pain or cough||
2004|121|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2004|122|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2004|123|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2004|124|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2004|125|I|diphenhydramine).||
2004|126|I|   Check the labels on all your medicines (such as allergy or||
2004|127|I|cough-and-cold products) because they may contain ingredients||
2004|128|I|that cause drowsiness or cause your heart to beat faster. Ask||
2004|129|I|your pharmacist about using those products safely.||
2004|130|I|   This medication may interfere with certain lab tests (such as||
2004|131|I|gastric secretion test), possibly causing false test results.||
2004|132|I|Make sure lab personnel and all your doctors know you use this||
2004|133|I|drug.||
2004|134|B|||
2004|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2004|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2004|137|O|poison control center right away. US residents can call||
2004|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2004|139|O|Symptoms of overdose may include: extreme drowsiness, trouble||
2004|140|O|breathing, hot/dry skin, fever, mental/mood changes,||
2004|141|O|fast/irregular heartbeat, seizures.||
2004|142|B|||
2004|143|N|NOTES:  Do not share this medication with others.||
2004|144|B|||
2004|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2004|146|D|remember. If it is near the time of the next dose, skip the||
2004|147|D|missed dose. Take your next dose at the regular time. Do not||
2004|148|D|double the dose to catch up.||
2004|149|B|||
2004|150|R|STORAGE:  Store at room temperature away from light and moisture.||
2004|151|R|Do not store in the bathroom. Keep all medications away from||
2004|152|R|children and pets.||
2004|153|R|   Do not flush medications down the toilet or pour them into a||
2004|154|R|drain unless instructed to do so. Properly discard this product||
2004|155|R|when it is expired or no longer needed. Consult your pharmacist||
2004|156|R|or local waste disposal company.||
2004|157|B|||
2004|158|A|Information last revised October 2025.||
2004|159|A|Copyright(c) 2025 First Databank, Inc.||
2004|160|B|||
2006|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2006|002|Z|does NOT have all possible information about this product. This||
2006|003|Z|information does not assure that this product is safe, effective,||
2006|004|Z|or appropriate for you. This information is not individual||
2006|005|Z|medical advice and does not substitute for the advice of your||
2006|006|Z|health care professional. Always ask your health care||
2006|007|Z|professional for complete information about this product and your||
2006|008|Z|specific health needs.||
2006|009|B|||
2006|010|T|ZOPICLONE - ORAL||
2006|011|F|(ZOE-pih-clone)||
2006|012|B|||
2006|013|W|WARNING:  Rarely, after taking this drug, people have gotten out||
2006|014|W|of bed and driven vehicles while not fully awake||
2006|015|W|("sleep-driving"). People have also sleepwalked, prepared/eaten||
2006|016|W|food, made phone calls, or had sex while not fully awake. Often,||
2006|017|W|these people do not remember these events. This problem can be||
2006|018|W|dangerous (possibly fatal) to you or to others. If you find out||
2006|019|W|that you have done any of these activities after taking this||
2006|020|W|medication, tell your doctor right away. You should not take this||
2006|021|W|medication or similar medications (such as eszopiclone, zolpidem)||
2006|022|W|if you have this reaction to the medication.||
2006|023|B|||
2006|024|U|USES:  Zopiclone is used to treat a certain sleep problem||
2006|025|U|(insomnia). It may help you fall asleep faster, stay asleep||
2006|026|U|longer, and reduce the number of times you wake up during the||
2006|027|U|night. Getting better sleep makes you feel well rested and||
2006|028|U|improves your energy level. Zopiclone belongs to a class of drugs||
2006|029|U|known as sedatives/hypnotics. It acts in your brain to produce a||
2006|030|U|calming effect.||
2006|031|U|   This medication is usually limited to short-term treatment||
2006|032|U|periods of 7 to 10 days or less.||
2006|033|B|||
2006|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2006|035|H|from your pharmacist before you start taking zopiclone and each||
2006|036|H|time you get a refill. If you have any questions, ask your doctor||
2006|037|H|or pharmacist.||
2006|038|H|   Take this medication by mouth as directed by your doctor,||
2006|039|H|usually once nightly just before bedtime. The dosage is based on||
2006|040|H|your medical condition, age, other medications you may be taking,||
2006|041|H|and response to treatment. Be sure to tell your doctor and||
2006|042|H|pharmacist about all the products you use (including prescription||
2006|043|H|drugs, nonprescription drugs, and herbal products).||
2006|044|H|    To reduce your risk of side effects, your doctor will direct||
2006|045|H|you to start this medication at a low dose and gradually increase||
2006|046|H|your dose if needed. Follow your doctor's instructions carefully.||
2006|047|H|Do not take more of this medication than prescribed because your||
2006|048|H|risk of side effects will increase.||
2006|049|H|   Although unlikely, this drug may rarely cause temporary memory||
2006|050|H|loss. To avoid this effect, do not take a dose of this drug||
2006|051|H|unless you have time for a full night's sleep of at least 7 to 8||
2006|052|H|hours. This amount of time is needed for your body to get over||
2006|053|H|the effects of this drug. For example, do not take zopiclone to||
2006|054|H|help you sleep during an overnight plane flight of less than 7 to||
2006|055|H|8 hours.||
2006|056|H|   If you suddenly stop using this medication, you may have||
2006|057|H|withdrawal symptoms (such as stomach/muscle cramps, shaking,||
2006|058|H|sweating, anxiety, vomiting, rare seizures). To help prevent||
2006|059|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
2006|060|H|more likely if you have used zopiclone for a long time or in high||
2006|061|H|doses. Tell your doctor or pharmacist right away if you have||
2006|062|H|withdrawal.||
2006|063|H|   When this medication is used for a long time, it may not work||
2006|064|H|as well. Talk with your doctor if this medication stops working||
2006|065|H|well.||
2006|066|H|   Though it helps many people, this medication may sometimes||
2006|067|H|cause addiction. This risk may be higher if you have a substance||
2006|068|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2006|069|H|Take this medication exactly as prescribed to lower the risk of||
2006|070|H|addiction. Ask your doctor or pharmacist for more details.||
2006|071|H|   You may have trouble sleeping the first few nights after you||
2006|072|H|stop taking this medication. This is called rebound insomnia and||
2006|073|H|it is normal. It will usually go away after 1 to 2 days. If this||
2006|074|H|effect continues, contact your doctor.||
2006|075|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
2006|076|H|or if it gets worse.||
2006|077|B|||
2006|078|S|SIDE EFFECTS:  See also Warning section.||
2006|079|S|   Dizziness, lightheadedness, bitter taste, dry mouth, or||
2006|080|S|stomach upset may occur. If any of these effects last or get||
2006|081|S|worse, tell your doctor or pharmacist promptly.||
2006|082|S|   This medication may make you sleepy during the day. Tell your||
2006|083|S|doctor if you have daytime drowsiness. Your dose may need to be||
2006|084|S|adjusted.||
2006|085|S|   To reduce the chance of falling, remember to get up slowly||
2006|086|S|when rising from a sitting or lying position.||
2006|087|S|   Remember that this medication has been prescribed because your||
2006|088|S|doctor has judged that the benefit to you is greater than the||
2006|089|S|risk of side effects. Many people using this medication do not||
2006|090|S|have serious side effects.||
2006|091|S|   Tell your doctor right away if you have any serious side||
2006|092|S|effects, including: fast/pounding heartbeat, memory loss, loss of||
2006|093|S|coordination, mental/mood/behavior changes (such as new/worsening||
2006|094|S|depression, abnormal thoughts, rare thoughts of suicide,||
2006|095|S|confusion, anxiety, restlessness, aggression).||
2006|096|S|   A very serious allergic reaction to this drug is rare.||
2006|097|S|However, get medical help right away if you notice any symptoms||
2006|098|S|of a serious allergic reaction, including: rash, itching/swelling||
2006|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2006|100|S|breathing.||
2006|101|S|   This is not a complete list of possible side effects. If you||
2006|102|S|notice other effects not listed above, contact your doctor or||
2006|103|S|pharmacist.||
2006|104|S|   In the US -||
2006|105|S|   Call your doctor for medical advice about side effects. You||
2006|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2006|107|S|www.fda.gov/medwatch.||
2006|108|S|   In Canada - Call your doctor for medical advice about side||
2006|109|S|effects. You may report side effects to Health Canada at||
2006|110|S|1-866-234-2345.||
2006|111|B|||
2006|112|P|PRECAUTIONS:  See also Warning section.||
2006|113|P|   Before taking zopiclone, tell your doctor or pharmacist if you||
2006|114|P|are allergic to it; or to eszopiclone; or if you have any other||
2006|115|P|allergies. This product may contain inactive ingredients, which||
2006|116|P|can cause allergic reactions or other problems. Talk to your||
2006|117|P|pharmacist for more details.||
2006|118|P|   Before using this medication, tell your doctor or pharmacist||
2006|119|P|your medical history, especially of: lung/breathing problems||
2006|120|P|(such as asthma, emphysema, sleep apnea), a certain muscle||
2006|121|P|disease (myasthenia gravis), personal or family history of a||
2006|122|P|substance use disorder (such as overuse of or addiction to||
2006|123|P|drugs/alcohol), mental/mood/behavior disorders (such as||
2006|124|P|depression, personality disorders, confusion), personal or family||
2006|125|P|history of sleepwalking, kidney disease, liver disease.||
2006|126|P|   The effects of this drug can last even after you wake up the||
2006|127|P|next day. If you did not get 7 to 8 hours of sleep or took other||
2006|128|P|medications that made you sleepy or are more sensitive to this||
2006|129|P|drug, you may feel alert but not think clearly enough to drive.||
2006|130|P|Alcohol or marijuana (cannabis) can also make you more sleepy.||
2006|131|P|Wait at least 12 hours after taking this drug before driving, and||
2006|132|P|do not drive, use machinery, or do anything that needs alertness||
2006|133|P|until you can do it safely. Avoid alcoholic beverages. Talk to||
2006|134|P|your doctor if you are using marijuana (cannabis).||
2006|135|P|   Before having surgery, tell your doctor or dentist about all||
2006|136|P|the products you use (including prescription drugs,||
2006|137|P|nonprescription drugs, and herbal products).||
2006|138|P|   Older adults may be more sensitive to the effects of this||
2006|139|P|drug, especially extreme drowsiness, dizziness, increased risk||
2006|140|P|for falls, memory loss, confusion, fast/pounding heartbeat.||
2006|141|P|   Tell your doctor if you are pregnant or plan to become||
2006|142|P|pregnant. You should not become pregnant while using zopiclone.||
2006|143|P|Zopiclone may harm an unborn baby. This drug may cause withdrawal||
2006|144|P|symptoms and other problems in a newborn baby when used for a||
2006|145|P|long time during pregnancy or near the time of delivery. If you||
2006|146|P|become pregnant, talk to your doctor right away about the risks||
2006|147|P|and benefits of this medication.||
2006|148|P|   This medication passes into breast milk and may have||
2006|149|P|undesirable effects on a nursing infant. Breastfeeding is not||
2006|150|P|recommended while using this medication. Consult your doctor||
2006|151|P|before breastfeeding.||
2006|152|B|||
2006|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2006|154|I|medications work or increase your risk for serious side effects.||
2006|155|I|This document does not contain all possible drug interactions.||
2006|156|I|Keep a list of all the products you use (including||
2006|157|I|prescription/nonprescription drugs and herbal products) and share||
2006|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
2006|159|I|the dosage of any medicines without your doctor's approval.||
2006|160|I|   A product that may interact with this drug is: sodium oxybate.||
2006|161|I|   The risk of serious side effects (such as slow/shallow||
2006|162|I|breathing, severe drowsiness/dizziness) may be increased if this||
2006|163|I|medication is taken with other products that may also cause||
2006|164|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2006|165|I|if you are taking other products such as opioid pain or cough||
2006|166|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2006|167|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
2006|168|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2006|169|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2006|170|I|diphenhydramine).||
2006|171|I|   Check the labels on all your medicines (such as allergy or||
2006|172|I|cough-and-cold products) because they may contain ingredients||
2006|173|I|that cause drowsiness. Ask your pharmacist about using those||
2006|174|I|products safely.||
2006|175|I|   Zopiclone is very similar to eszopiclone. Do not use||
2006|176|I|medications containing eszopiclone while using zopiclone.||
2006|177|B|||
2006|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2006|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2006|180|O|poison control center right away. US residents can call||
2006|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2006|182|O|Symptoms of overdose may include: slow/shallow breathing, trouble||
2006|183|O|speaking, a deep sleep from which you cannot be awakened.||
2006|184|B|||
2006|185|N|NOTES:  Do not share this medication with others. Sharing it is||
2006|186|N|against the law.||
2006|187|N|   As you get older, your sleep pattern may naturally change and||
2006|188|N|your sleep may be interrupted several times during the night.||
2006|189|N|Consult your doctor or pharmacist for ways to improve your sleep||
2006|190|N|without medication, such as avoiding caffeine and alcohol close||
2006|191|N|to bedtime, avoiding daytime naps, and going to bed at the same||
2006|192|N|time each night.||
2006|193|B|||
2006|194|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
2006|195|D|time to sleep for 7 to 8 hours afterward. (See also How to Use||
2006|196|D|section.)||
2006|197|B|||
2006|198|R|STORAGE:  Store at room temperature away from light and moisture.||
2006|199|R|Do not store in the bathroom. Keep all medications away from||
2006|200|R|children and pets.||
2006|201|R|   Do not flush medications down the toilet or pour them into a||
2006|202|R|drain unless instructed to do so. Properly discard this product||
2006|203|R|when it is expired or no longer needed. Consult your pharmacist||
2006|204|R|or local waste disposal company.||
2006|205|B|||
2006|206|A|Information last revised May 2024.||
2006|207|A|Copyright(c) 2025 First Databank, Inc.||
2006|208|B|||
2007|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2007|002|Z|does NOT have all possible information about this product. This||
2007|003|Z|information does not assure that this product is safe, effective,||
2007|004|Z|or appropriate for you. This information is not individual||
2007|005|Z|medical advice and does not substitute for the advice of your||
2007|006|Z|health care professional. Always ask your health care||
2007|007|Z|professional for complete information about this product and your||
2007|008|Z|specific health needs.||
2007|009|B|||
2007|010|T|PEGVISOMANT - INJECTION||
2007|011|F|(peg-VIH-so-mant)||
2007|012|B|||
2007|013|C|COMMON BRAND NAME(S): Somavert||
2007|014|B|||
2007|015|U|USES:  Pegvisomant is used to treat a certain condition called||
2007|016|U|acromegaly. Acromegaly occurs when the body makes too much growth||
2007|017|U|hormone and other natural substances such as insulin-like growth||
2007|018|U|factor-I (IGF-I). Pegvisomant is usually used if you have not||
2007|019|U|responded to other treatments (such as surgery, radiation, other||
2007|020|U|medications). Treating acromegaly helps reduce the risk of||
2007|021|U|serious problems such as diabetes and heart disease. Pegvisomant||
2007|022|U|works by blocking the action of growth hormone and by reducing||
2007|023|U|the amount of IGF-I to normal levels.||
2007|024|B|||
2007|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
2007|026|H|Instructions for Use if available from your pharmacist before you||
2007|027|H|start using pegvisomant and each time you get a refill. Ask your||
2007|028|H|health care professional how to prepare and use this medication.||
2007|029|H|If you have any questions, ask your doctor or pharmacist.||
2007|030|H|   Inject this medication under the skin as directed by your||
2007|031|H|doctor, usually once daily. The injection is given in the upper||
2007|032|H|arm, upper thigh, stomach area, or buttock. The dosage is based||
2007|033|H|on your medical condition, lab tests, and response to treatment.||
2007|034|H|The first dose is usually given by a health care professional.||
2007|035|H|   Take the medication out of the refrigerator at least 10||
2007|036|H|minutes before you inject it to allow it to reach room||
2007|037|H|temperature. Do not warm up this medication any other way (for||
2007|038|H|example, do not heat it in the microwave or place it in hot||
2007|039|H|water). Gently roll the vial back and forth in your palms to||
2007|040|H|dissolve the powder in the mixing solution. Before using, check||
2007|041|H|this product for particles or discoloration. If either is||
2007|042|H|present, do not use the liquid. Do not shake the medication.||
2007|043|H|Before injecting each dose, clean the skin you are going to||
2007|044|H|inject into (the injection site) with rubbing alcohol. Change the||
2007|045|H|injection site each time to lessen injury under the skin. Do not||
2007|046|H|inject into skin that is bruised, lumpy, or irritated. To lessen||
2007|047|H|bruising, do not rub the injection site after a shot. Learn how||
2007|048|H|to store and discard medical supplies safely.||
2007|049|H|   Use this medication regularly in order to get the most benefit||
2007|050|H|from it. To help you remember, use it at the same time each day.||
2007|051|H|   Tell your doctor if your condition does not get better or if||
2007|052|H|it gets worse.||
2007|053|B|||
2007|054|S|SIDE EFFECTS:  Lumps may occur under the skin if the same||
2007|055|S|injection site is used often. To reduce the chance of this side||
2007|056|S|effect, change the injection site daily. Redness/swelling at the||
2007|057|S|injection site, pain, diarrhea, or nausea may also occur. If any||
2007|058|S|of these effects last or get worse, tell your doctor or||
2007|059|S|pharmacist promptly.||
2007|060|S|   Remember that this medication has been prescribed because your||
2007|061|S|doctor has judged that the benefit to you is greater than the||
2007|062|S|risk of side effects. Many people using this medication do not||
2007|063|S|have serious side effects.||
2007|064|S|   Get medical help right away if you have any very serious side||
2007|065|S|effects, including: signs of liver problems (such as||
2007|066|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
2007|067|S|unusual tiredness, yellowing eyes/skin, dark urine).||
2007|068|S|   A very serious allergic reaction to this drug is rare.||
2007|069|S|However, get medical help right away if you notice any symptoms||
2007|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2007|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2007|072|S|breathing.||
2007|073|S|   This is not a complete list of possible side effects. If you||
2007|074|S|notice other effects not listed above, contact your doctor or||
2007|075|S|pharmacist.||
2007|076|S|   In the US -||
2007|077|S|   Call your doctor for medical advice about side effects. You||
2007|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2007|079|S|www.fda.gov/medwatch.||
2007|080|S|   In Canada - Call your doctor for medical advice about side||
2007|081|S|effects. You may report side effects to Health Canada at||
2007|082|S|1-866-234-2345.||
2007|083|B|||
2007|084|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2007|085|P|pharmacist if you are allergic to it or if you have any other||
2007|086|P|allergies. This product may contain inactive ingredients (such as||
2007|087|P|dry natural rubber/latex in the product packaging), which can||
2007|088|P|cause allergic reactions or other problems. Talk to your||
2007|089|P|pharmacist for more details.||
2007|090|P|   Before using this medication, tell your doctor or pharmacist||
2007|091|P|your medical history, especially of: liver problems.||
2007|092|P|   If you have diabetes, pegvisomant may help improve symptoms of||
2007|093|P|diabetes, such as lowering high blood sugar. Check your blood||
2007|094|P|sugar regularly as directed and share the results with your||
2007|095|P|doctor. Your doctor may need to adjust your diabetes medication,||
2007|096|P|exercise program, or diet.||
2007|097|P|   Before having surgery, tell your doctor or dentist about all||
2007|098|P|the products you use (including prescription drugs,||
2007|099|P|nonprescription drugs, and herbal products).||
2007|100|P|   During pregnancy, this medication should be used only when||
2007|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
2007|102|P|   It is unknown if this medication passes into breast milk.||
2007|103|P|Consult your doctor before breastfeeding.||
2007|104|B|||
2007|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2007|106|I|medications work or increase your risk for serious side effects.||
2007|107|I|This document does not contain all possible drug interactions.||
2007|108|I|Keep a list of all the products you use (including||
2007|109|I|prescription/nonprescription drugs and herbal products) and share||
2007|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
2007|111|I|the dosage of any medicines without your doctor's approval.||
2007|112|I|   Some products that may interact with this drug include:||
2007|113|I|somatostatin analogs (such as lanreotide, octreotide).||
2007|114|B|||
2007|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2007|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2007|117|O|poison control center right away. US residents can call||
2007|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2007|119|O|Symptoms of overdose may include: increased tiredness.||
2007|120|B|||
2007|121|N|NOTES:  Do not share this medication with others.||
2007|122|N|   Lab and/or medical tests (such as liver function, IGF-I||
2007|123|N|levels) should be done before you start using this medication and||
2007|124|N|while you are using it. Keep all medical and lab appointments.||
2007|125|N|Consult your doctor for more details.||
2007|126|B|||
2007|127|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2007|128|D|If it is near the time of the next dose, skip the missed dose.||
2007|129|D|Use your next dose at the regular time. Do not double the dose to||
2007|130|D|catch up.||
2007|131|B|||
2007|132|R|STORAGE:  Store in the refrigerator. Do not freeze. Use this||
2007|133|R|medication immediately after mixing or within the time period||
2007|134|R|indicated in the product instructions. Discard any unused portion||
2007|135|R|remaining in the vial. Keep all medications away from children||
2007|136|R|and pets.||
2007|137|R|   Do not flush medications down the toilet or pour them into a||
2007|138|R|drain unless instructed to do so. Properly discard this product||
2007|139|R|when it is expired or no longer needed. Consult your pharmacist||
2007|140|R|or local waste disposal company.||
2007|141|B|||
2007|142|A|Information last revised October 2024.||
2007|143|A|Copyright(c) 2025 First Databank, Inc.||
2007|144|B|||
2008|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2008|002|Z|does NOT have all possible information about this product. This||
2008|003|Z|information does not assure that this product is safe, effective,||
2008|004|Z|or appropriate for you. This information is not individual||
2008|005|Z|medical advice and does not substitute for the advice of your||
2008|006|Z|health care professional. Always ask your health care||
2008|007|Z|professional for complete information about this product and your||
2008|008|Z|specific health needs.||
2008|009|B|||
2008|010|T|ALBUTEROL (SALBUTAMOL) PRE-MIXED SOLUTION - INHALATION||
2008|011|F|(al-BUE-ter-ol/sal-BUE-ta-mol)||
2008|012|B|||
2008|013|C|COMMON BRAND NAME(S): Proventil, Ventolin||
2008|014|B|||
2008|015|U|USES:  Albuterol (also known as salbutamol) is used to treat||
2008|016|U|wheezing and shortness of breath caused by breathing problems||
2008|017|U|such as asthma. It is a quick-relief medication. Albuterol||
2008|018|U|belongs to a class of drugs known as bronchodilators. It works by||
2008|019|U|relaxing the muscles around the airways so that they open up and||
2008|020|U|you can breathe more easily. Controlling symptoms of breathing||
2008|021|U|problems can decrease time lost from work or school.||
2008|022|B|||
2008|023|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
2008|024|H|your pharmacist before you start using this medication and each||
2008|025|H|time you get a refill. This medication is used with a special||
2008|026|H|machine called a nebulizer that changes the solution to a fine||
2008|027|H|mist that you inhale. Learn all instructions for the use of this||
2008|028|H|medication and the nebulizer. If a child is using this||
2008|029|H|medication, a parent or other responsible adult should supervise||
2008|030|H|the child. If you have any questions, ask your doctor,||
2008|031|H|pharmacist, or respiratory therapist.||
2008|032|H|   This product should be clear and colorless. Before using,||
2008|033|H|check this product for particles or discoloration. If either is||
2008|034|H|present, do not use the liquid.||
2008|035|H|   This medication does not require any mixing before use. Using||
2008|036|H|a mouthpiece or face mask with the nebulizer, inhale the||
2008|037|H|prescribed dose of medication into your lungs as directed by your||
2008|038|H|doctor, usually 3 or 4 times daily as needed. Each treatment||
2008|039|H|usually takes about 5 to 15 minutes. Use this medication only||
2008|040|H|through a nebulizer. Do not swallow or inject the solution. Do||
2008|041|H|not mix with other medicines in your nebulizer. To prevent||
2008|042|H|infections, clean the nebulizer and mouthpiece/face mask||
2008|043|H|according to the manufacturer's directions.||
2008|044|H|   Dosage is based on your medical condition, age, weight, and||
2008|045|H|response to treatment. Do not increase your dose or use this drug||
2008|046|H|more often than prescribed without your doctor's approval. Using||
2008|047|H|too much of this medication will increase your risk of serious||
2008|048|H|(possibly fatal) side effects.||
2008|049|H|   Learn which of your inhalers/medications you should use every||
2008|050|H|day (controller drugs) and which you should use if your breathing||
2008|051|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
2008|052|H|time what you should do if you have new or worsening cough or||
2008|053|H|shortness of breath, wheezing, increased sputum, worsening peak||
2008|054|H|flow meter readings, waking up at night with trouble breathing,||
2008|055|H|if you use your quick-relief inhaler/medication more often (more||
2008|056|H|than 2 days a week), or if your quick-relief inhaler/medication||
2008|057|H|does not seem to be working well. Learn when you can treat sudden||
2008|058|H|breathing problems by yourself and when you must get medical help||
2008|059|H|right away.||
2008|060|H|   Tell your doctor if your symptoms do not get better or if they||
2008|061|H|get worse.||
2008|062|B|||
2008|063|S|SIDE EFFECTS:  Nervousness, shaking (tremor), headache, nausea or||
2008|064|S|dizziness may occur. If any of these effects last or get worse,||
2008|065|S|tell your doctor or pharmacist promptly.||
2008|066|S|   Remember that this medication has been prescribed because your||
2008|067|S|doctor has judged that the benefit to you is greater than the||
2008|068|S|risk of side effects. Many people using this medication do not||
2008|069|S|have serious side effects.||
2008|070|S|   This medication may raise your blood pressure. Check your||
2008|071|S|blood pressure regularly and tell your doctor if the results are||
2008|072|S|high.||
2008|073|S|   Tell your doctor right away if you have any serious side||
2008|074|S|effects, including: fast/pounding heartbeat.||
2008|075|S|   Get medical help right away if you have any very serious side||
2008|076|S|effects, including: chest pain, irregular heartbeat, rapid||
2008|077|S|breathing, confusion.||
2008|078|S|   Rarely, this medication has caused severe (rarely fatal),||
2008|079|S|sudden worsening of breathing problems/asthma (paradoxical||
2008|080|S|bronchospasm). If you experience sudden wheezing, get medical||
2008|081|S|help right away.||
2008|082|S|   A very serious allergic reaction to this drug is rare.||
2008|083|S|However, get medical help right away if you notice any symptoms||
2008|084|S|of a serious allergic reaction, including: rash, itching/swelling||
2008|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2008|086|S|breathing.||
2008|087|S|   This is not a complete list of possible side effects. If you||
2008|088|S|notice other effects not listed above, contact your doctor or||
2008|089|S|pharmacist.||
2008|090|S|   In the US -||
2008|091|S|   Call your doctor for medical advice about side effects. You||
2008|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2008|093|S|www.fda.gov/medwatch.||
2008|094|S|   In Canada - Call your doctor for medical advice about side||
2008|095|S|effects. You may report side effects to Health Canada at||
2008|096|S|1-866-234-2345.||
2008|097|B|||
2008|098|P|PRECAUTIONS:  Before using albuterol, tell your doctor or||
2008|099|P|pharmacist if you are allergic to it; or if you have had a||
2008|100|P|serious reaction to similar drugs (such as levalbuterol,||
2008|101|P|metaproterenol, terbutaline); or if you have any other allergies.||
2008|102|P|This product may contain inactive ingredients, which can cause||
2008|103|P|allergic reactions or other problems. Talk to your pharmacist for||
2008|104|P|more details.||
2008|105|P|   Before using this medication, tell your doctor or pharmacist||
2008|106|P|your medical history, especially of: heart problems (such as||
2008|107|P|irregular heartbeat, angina, heart attack), high blood pressure,||
2008|108|P|diabetes, seizure.||
2008|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2008|110|P|can make you more dizzy. Do not drive, use machinery, or do||
2008|111|P|anything that needs alertness until you can do it safely. Limit||
2008|112|P|alcoholic beverages. Talk to your doctor if you are using||
2008|113|P|marijuana (cannabis).||
2008|114|P|   Before having surgery, tell your doctor or dentist about all||
2008|115|P|the products you use (including prescription drugs,||
2008|116|P|nonprescription drugs, and herbal products).||
2008|117|P|   During pregnancy, this medication should be used only when||
2008|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
2008|119|P|   It is unknown if this medication passes into breast milk.||
2008|120|P|Consult your doctor before breastfeeding.||
2008|121|B|||
2008|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2008|123|I|medications work or increase your risk for serious side effects.||
2008|124|I|This document does not contain all possible drug interactions.||
2008|125|I|Keep a list of all the products you use (including||
2008|126|I|prescription/nonprescription drugs and herbal products) and share||
2008|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
2008|128|I|the dosage of any medicines without your doctor's approval.||
2008|129|I|   Albuterol is very similar to levalbuterol. Do not use||
2008|130|I|medications containing levalbuterol while using albuterol.||
2008|131|B|||
2008|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2008|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2008|134|O|poison control center right away. US residents can call||
2008|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2008|136|O|Symptoms of overdose may include: fast/pounding/irregular||
2008|137|O|heartbeat, severe shaking (tremors), seizures.||
2008|138|B|||
2008|139|N|NOTES:  Do not share this medication with others.||
2008|140|N|   Lab and/or medical tests (such as lung function, blood||
2008|141|N|pressure) should be done while you are using this medication.||
2008|142|N|Keep all medical and lab appointments. Consult your doctor for||
2008|143|N|more details.||
2008|144|N|   Avoid allergens/irritants such as smoke, pollen, pet dander,||
2008|145|N|dust, or molds that may worsen breathing problems.||
2008|146|N|   Learn to use a peak flow meter, use it daily, and promptly||
2008|147|N|report worsening breathing problems (such as readings in the||
2008|148|N|yellow/red range, increased use of quick-relief inhalers).||
2008|149|N|   Ask your doctor or pharmacist whether you should have an||
2008|150|N|annual flu shot.||
2008|151|B|||
2008|152|D|MISSED DOSE:  If you are using this medication on a prescribed||
2008|153|D|schedule and miss a dose, use it as soon as you remember. If it||
2008|154|D|is near the time of the next dose, skip the missed dose. Use your||
2008|155|D|next dose at the regular time. Do not double the dose to catch||
2008|156|D|up.||
2008|157|B|||
2008|158|R|STORAGE:  Different brands of this medication have different||
2008|159|R|storage needs. Check the product package for instructions on how||
2008|160|R|to store your brand, or ask your pharmacist. Keep all medications||
2008|161|R|away from children and pets.||
2008|162|R|   Do not flush medications down the toilet or pour them into a||
2008|163|R|drain unless instructed to do so. Properly discard this product||
2008|164|R|when it is expired or no longer needed. Consult your pharmacist||
2008|165|R|or local waste disposal company.||
2008|166|B|||
2008|167|M|MEDICAL ALERT:  Your condition can cause complications in a||
2008|168|M|medical emergency. For information about enrolling in MedicAlert,||
2008|169|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2008|170|B|||
2008|171|A|Information last revised January 2025.||
2008|172|A|Copyright(c) 2025 First Databank, Inc.||
2008|173|B|||
2009|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2009|002|Z|does NOT have all possible information about this product. This||
2009|003|Z|information does not assure that this product is safe, effective,||
2009|004|Z|or appropriate for you. This information is not individual||
2009|005|Z|medical advice and does not substitute for the advice of your||
2009|006|Z|health care professional. Always ask your health care||
2009|007|Z|professional for complete information about this product and your||
2009|008|Z|specific health needs.||
2009|009|B|||
2009|010|T|TRIENTINE - ORAL||
2009|011|F|(TRYE-en-teen)||
2009|012|B|||
2009|013|C|COMMON BRAND NAME(S):  Cuvrior, Syprine||
2009|014|B|||
2009|015|U|USES:  This medication is used to treat a certain inherited||
2009|016|U|disorder (Wilson's disease). This disorder causes too much copper||
2009|017|U|to build up in the liver, brain, and other parts of the body.||
2009|018|U|Trientine works by binding to copper, which helps your body get||
2009|019|U|rid of extra copper. This can decrease symptoms such as problems||
2009|020|U|with speech/swallowing/coordination, tiredness, lack of appetite,||
2009|021|U|abdominal pain, yellowing eyes/skin, fluid buildup in the||
2009|022|U|legs/abdomen, uncontrolled movements, or muscle stiffness.||
2009|023|B|||
2009|024|H|HOW TO USE:  Take this medication by mouth on an empty stomach,||
2009|025|H|at least 1 hour before meals or 2 hours after meals as directed||
2009|026|H|by your doctor, usually 2 to 4 times daily. Take this medication||
2009|027|H|at least 1 hour apart from any other drug, food, or milk.||
2009|028|H|   If you are taking the capsule form of this medication, swallow||
2009|029|H|the capsules whole with water. Do not open or chew the capsules.||
2009|030|H|If you accidentally come in contact with the capsule contents,||
2009|031|H|wash the area promptly with water to avoid an allergic reaction.||
2009|032|H|   If you are taking the tablet form of this medication, do not||
2009|033|H|crush, chew or dissolve the tablets. Also, do not split the||
2009|034|H|tablets unless they have a score line and your doctor or||
2009|035|H|pharmacist tells you to do so. Swallow the whole or split tablet||
2009|036|H|without crushing or chewing. Do not remove the tablet from the||
2009|037|H|blister pack until right before using.||
2009|038|H|   If you are taking a certain medication called penicillamine,||
2009|039|H|your doctor will direct you to stop the medication before||
2009|040|H|starting trientine. Consult your doctor or pharmacist for more||
2009|041|H|details.||
2009|042|H|   The dosage is based on your medical condition and response to||
2009|043|H|treatment. Do not change dosage forms of this medication without||
2009|044|H|checking with your doctor or pharmacist.||
2009|045|H|   If your doctor directs you to also take an iron supplement,||
2009|046|H|take it at least 2 hours before or after trientine.||
2009|047|H|   Use this medication regularly to get the most benefit from it.||
2009|048|H|To help you remember, take it at the same times each day.||
2009|049|H|   Do not increase your dose or use this drug more often or for||
2009|050|H|longer than prescribed. Your condition will not improve any||
2009|051|H|faster, and your risk of side effects will increase.||
2009|052|H|   You may notice worsening in certain symptoms of Wilson's||
2009|053|H|disease (such as problems with speech/swallowing/coordination,||
2009|054|H|uncontrolled movements) when you start taking trientine as the||
2009|055|H|medication begins to work to reduce the copper levels in your||
2009|056|H|body. Always tell your doctor right away about these symptoms.||
2009|057|H|   Tell your doctor if you do not get better or if you get worse.||
2009|058|B|||
2009|059|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
2009|060|S|because your doctor has judged that the benefit to you is greater||
2009|061|S|than the risk of side effects. Many people using this medication||
2009|062|S|do not have serious side effects.||
2009|063|S|   This medication and a low-copper diet may increase the risk||
2009|064|S|for iron deficiency. Tell your doctor right away if you have||
2009|065|S|symptoms such as feeling very tired, weakness, pale skin, chest||
2009|066|S|pain, fast heartbeat, shortness of breath, cold hands/feet. Your||
2009|067|S|doctor may direct you to take an iron supplement for a short time||
2009|068|S|(see also How to Use section).||
2009|069|S|   A very serious allergic reaction to this drug is rare.||
2009|070|S|However, get medical help right away if you notice any symptoms||
2009|071|S|of a serious allergic reaction, including: rash, itching/swelling||
2009|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2009|073|S|breathing.||
2009|074|S|   This is not a complete list of possible side effects. If you||
2009|075|S|notice other effects not listed above, contact your doctor or||
2009|076|S|pharmacist.||
2009|077|S|   In the US -||
2009|078|S|   Call your doctor for medical advice about side effects. You||
2009|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2009|080|S|www.fda.gov/medwatch.||
2009|081|S|   In Canada - Call your doctor for medical advice about side||
2009|082|S|effects. You may report side effects to Health Canada at||
2009|083|S|1-866-234-2345.||
2009|084|B|||
2009|085|P|PRECAUTIONS:  Before taking trientine, tell your doctor or||
2009|086|P|pharmacist if you are allergic to it; or if you have any other||
2009|087|P|allergies. This product may contain inactive ingredients, which||
2009|088|P|can cause allergic reactions or other problems. Talk to your||
2009|089|P|pharmacist for more details.||
2009|090|P|   Before using this medication, tell your doctor or pharmacist||
2009|091|P|your medical history.||
2009|092|P|   Before having surgery, tell your doctor or dentist about all||
2009|093|P|the products you use (including prescription drugs,||
2009|094|P|nonprescription drugs, and herbal products).||
2009|095|P|   Children and pregnant or menstruating women may be at greater||
2009|096|P|risk for developing iron deficiency while taking this drug.||
2009|097|P|   During pregnancy, this medication should be used only when||
2009|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
2009|099|P|   It is unknown if this medication passes into breast milk.||
2009|100|P|Consult your doctor before breastfeeding.||
2009|101|B|||
2009|102|I|DRUG INTERACTIONS:  See also How to Use section.||
2009|103|I|   Drug interactions may change how your medications work or||
2009|104|I|increase your risk for serious side effects. This document does||
2009|105|I|not contain all possible drug interactions. Keep a list of all||
2009|106|I|the products you use (including prescription/nonprescription||
2009|107|I|drugs and herbal products) and share it with your doctor and||
2009|108|I|pharmacist. Do not start, stop, or change the dosage of any||
2009|109|I|medicines without your doctor's approval.||
2009|110|B|||
2009|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2009|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2009|113|O|poison control center right away. US residents can call||
2009|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2009|115|B|||
2009|116|N|NOTES:  Do not share this medication with others.||
2009|117|N|   Lab and/or medical tests (such as blood/urine copper levels)||
2009|118|N|should be done while you are taking this medication. Keep all||
2009|119|N|medical and lab appointments.||
2009|120|N|   For the best effect, follow a low-copper diet as directed by||
2009|121|N|your doctor.||
2009|122|B|||
2009|123|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2009|124|D|remember. If it is near the time of the next dose, skip the||
2009|125|D|missed dose. Take your next dose at the regular time. Do not||
2009|126|D|double the dose to catch up.||
2009|127|B|||
2009|128|R|STORAGE:  Different brands of this medication have different||
2009|129|R|storage needs. Check the product package for instructions on how||
2009|130|R|to store your brand, or ask your pharmacist. Keep all medications||
2009|131|R|away from children and pets.||
2009|132|R|   Do not flush medications down the toilet or pour them into a||
2009|133|R|drain unless instructed to do so. Properly discard this product||
2009|134|R|when it is expired or no longer needed. Consult your pharmacist||
2009|135|R|or local waste disposal company.||
2009|136|B|||
2009|137|A|Information last revised May 2024.||
2009|138|A|Copyright(c) 2025 First Databank, Inc.||
2009|139|B|||
2010|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2010|002|Z|does NOT have all possible information about this product. This||
2010|003|Z|information does not assure that this product is safe, effective,||
2010|004|Z|or appropriate for you. This information is not individual||
2010|005|Z|medical advice and does not substitute for the advice of your||
2010|006|Z|health care professional. Always ask your health care||
2010|007|Z|professional for complete information about this product and your||
2010|008|Z|specific health needs.||
2010|009|B|||
2010|010|T|NIFEDIPINE SUSTAINED-ACTION - ORAL||
2010|011|F|(nye-FED-i-peen)||
2010|012|B|||
2010|013|C|COMMON BRAND NAME(S): Adalat CC||
2010|014|B|||
2010|015|U|USES:  This medication is used alone or in combination with other||
2010|016|U|drugs to treat high blood pressure (hypertension). Lowering high||
2010|017|U|blood pressure helps prevent strokes, heart attacks, and kidney||
2010|018|U|problems. Nifedipine belongs to a class of medications known as||
2010|019|U|calcium channel blockers. It works by relaxing blood vessels so||
2010|020|U|blood can flow more easily.||
2010|021|B|||
2010|022|V|OTHER USES:  This section contains uses of this drug that are not||
2010|023|V|listed in the approved professional labeling for the drug but||
2010|024|V|that may be prescribed by your health care professional. Use this||
2010|025|V|drug for a condition that is listed in this section only if it||
2010|026|V|has been so prescribed by your health care professional.||
2010|027|V|   This drug may also be used for certain types of chest pain||
2010|028|V|(angina). It may help to increase your ability to exercise and||
2010|029|V|decrease the frequency of angina attacks. This drug must be taken||
2010|030|V|regularly to be effective. It should not be used to treat attacks||
2010|031|V|of chest pain when they occur. Use other medications (such as||
2010|032|V|sublingual nitroglycerin) to relieve attacks of chest pain as||
2010|033|V|directed by your doctor. Consult your doctor or pharmacist for||
2010|034|V|details.||
2010|035|V|   This drug may also be used for certain blood circulation||
2010|036|V|disorders (Raynaud's syndrome).||
2010|037|B|||
2010|038|H|HOW TO USE:  Take this medication by mouth on an empty stomach as||
2010|039|H|directed by your doctor, usually once daily. Swallow the tablets||
2010|040|H|whole. Do not crush or chew the tablets. Doing so can release all||
2010|041|H|of the drug at once, increasing the risk of side effects.||
2010|042|H|   Your doctor may gradually increase your dose. Follow your||
2010|043|H|doctor's instructions carefully. The dosage is based on your||
2010|044|H|medical condition and response to treatment.||
2010|045|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2010|046|H|using this medication unless your doctor or pharmacist says you||
2010|047|H|may do so safely. Grapefruit can increase the chance of side||
2010|048|H|effects with this medicine. Ask your doctor or pharmacist for||
2010|049|H|more details.||
2010|050|H|   Use this medication regularly in order to get the most benefit||
2010|051|H|from it. Remember to use it at the same time each day. Keep||
2010|052|H|taking this medication even if you feel well. Most people with||
2010|053|H|high blood pressure do not feel sick.||
2010|054|H|   Do not suddenly stop taking this medication without consulting||
2010|055|H|your doctor. Your condition may become worse when the drug is||
2010|056|H|suddenly stopped. Your dose may need to be gradually decreased.||
2010|057|H|   Tell your doctor if your condition does not get better or if||
2010|058|H|it gets worse (your blood pressure readings remain high or||
2010|059|H|increase).||
2010|060|B|||
2010|061|S|SIDE EFFECTS:  Headache, dizziness, nausea, flushing,||
2010|062|S|constipation, leg/muscle cramps, or sexual problems may occur. If||
2010|063|S|any of these effects last or get worse, tell your doctor or||
2010|064|S|pharmacist promptly.||
2010|065|S|   To reduce the risk of dizziness and lightheadedness, get up||
2010|066|S|slowly when rising from a sitting or lying position.||
2010|067|S|   Remember that this medication has been prescribed because your||
2010|068|S|doctor has judged that the benefit to you is greater than the||
2010|069|S|risk of side effects. Many people using this medication do not||
2010|070|S|have serious side effects.||
2010|071|S|   Tell your doctor right away if you have any serious side||
2010|072|S|effects, including: swelling of the ankles/feet, shortness of||
2010|073|S|breath, unusual weakness/tiredness, fast/slow/irregular||
2010|074|S|heartbeat, fainting, mental/mood changes, swollen/tender gums,||
2010|075|S|vision changes.||
2010|076|S|   Although this medication is effective in preventing chest pain||
2010|077|S|(angina), some people who already have severe heart disease may||
2010|078|S|rarely develop worsening chest pain or a heart attack after||
2010|079|S|starting this medication or increasing the dose. Get medical help||
2010|080|S|right away if you experience: worsening chest pain, symptoms of a||
2010|081|S|heart attack (such as chest/jaw/left arm pain, shortness of||
2010|082|S|breath, unusual sweating).||
2010|083|S|   A very serious allergic reaction to this drug is rare.||
2010|084|S|However, get medical help right away if you notice any symptoms||
2010|085|S|of a serious allergic reaction, including: rash, itching/swelling||
2010|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2010|087|S|breathing.||
2010|088|S|   This is not a complete list of possible side effects. If you||
2010|089|S|notice other effects not listed above, contact your doctor or||
2010|090|S|pharmacist.||
2010|091|S|   In the US -||
2010|092|S|   Call your doctor for medical advice about side effects. You||
2010|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2010|094|S|www.fda.gov/medwatch.||
2010|095|S|   In Canada - Call your doctor for medical advice about side||
2010|096|S|effects. You may report side effects to Health Canada at||
2010|097|S|1-866-234-2345.||
2010|098|B|||
2010|099|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2010|100|P|pharmacist if you are allergic to it; or to other calcium channel||
2010|101|P|blockers (such as felodipine, amlodipine); or if you have any||
2010|102|P|other allergies. This product may contain inactive ingredients,||
2010|103|P|which can cause allergic reactions or other problems. Talk to||
2010|104|P|your pharmacist for more details.||
2010|105|P|   Before using this medication, tell your doctor or pharmacist||
2010|106|P|your medical history, especially of: heart problems (such as||
2010|107|P|heart failure, aortic stenosis), liver problems, kidney problems,||
2010|108|P|a certain metabolic disorder (porphyria).||
2010|109|P|   Before having surgery, tell your doctor or dentist about all||
2010|110|P|the products you use (including prescription drugs,||
2010|111|P|nonprescription drugs, and herbal products).||
2010|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2010|113|P|can make you more dizzy. Do not drive, use machinery, or do||
2010|114|P|anything that needs alertness until you can do it safely. Limit||
2010|115|P|alcoholic beverages. Talk to your doctor if you are using||
2010|116|P|marijuana (cannabis).||
2010|117|P|   During pregnancy, this medication should be used only when||
2010|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
2010|119|P|   Nifedipine passes into breast milk. Consult your doctor before||
2010|120|P|breastfeeding.||
2010|121|B|||
2010|122|I|DRUG INTERACTIONS:  See also How to Use section.||
2010|123|I|   Drug interactions may change how your medications work or||
2010|124|I|increase your risk for serious side effects. This document does||
2010|125|I|not contain all possible drug interactions. Keep a list of all||
2010|126|I|the products you use (including prescription/nonprescription||
2010|127|I|drugs and herbal products) and share it with your doctor and||
2010|128|I|pharmacist. Do not start, stop, or change the dosage of any||
2010|129|I|medicines without your doctor's approval.||
2010|130|I|   Other medications can affect the removal of nifedipine from||
2010|131|I|your body, which may affect how nifedipine works. Examples||
2010|132|I|include apalutamide, enzalutamide, mitotane, St. John's wort,||
2010|133|I|rifamycins (such as rifabutin, rifampin), drugs used to treat||
2010|134|I|seizures (such as carbamazepine, phenobarbital, phenytoin), among||
2010|135|I|others.||
2010|136|I|   Some products have ingredients that could raise your heart||
2010|137|I|rate or blood pressure. Tell your pharmacist what products you||
2010|138|I|are using, and ask how to use them safely (especially||
2010|139|I|cough-and-cold products, diet aids, or NSAIDs such as||
2010|140|I|ibuprofen/naproxen).||
2010|141|B|||
2010|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2010|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2010|144|O|poison control center right away. US residents can call||
2010|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2010|146|O|Symptoms of overdose may include: severe dizziness, fainting,||
2010|147|O|fast/slow/irregular heartbeat.||
2010|148|B|||
2010|149|N|NOTES:  Do not share this medication with others.||
2010|150|N|   Lifestyle changes such as stress reduction programs, exercise,||
2010|151|N|and dietary changes may increase the effectiveness of this||
2010|152|N|medicine. Talk to your doctor or pharmacist about lifestyle||
2010|153|N|changes that might benefit you.||
2010|154|N|   Lab and/or medical tests (such as liver/kidney function, EKG)||
2010|155|N|may be done while you are taking this medication. Keep all||
2010|156|N|medical and lab appointments. Consult your doctor for more||
2010|157|N|details.||
2010|158|N|   Have your blood pressure checked regularly while taking this||
2010|159|N|medication. Learn how to monitor your own blood pressure at home,||
2010|160|N|and share the results with your doctor.||
2010|161|N|   There are different tablet strengths of this medication||
2010|162|N|available. Some tablet strengths may not be used in place of||
2010|163|N|others. Do not change tablet strengths or use a different number||
2010|164|N|of tablets for your dose without consulting your doctor or||
2010|165|N|pharmacist.||
2010|166|B|||
2010|167|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2010|168|D|remember. If it is near the time of the next dose, skip the||
2010|169|D|missed dose. Take your next dose at the regular time. Do not||
2010|170|D|double the dose to catch up.||
2010|171|B|||
2010|172|R|STORAGE:  Store at room temperature away from light and moisture.||
2010|173|R|Do not store in the bathroom. Keep all medications away from||
2010|174|R|children and pets.||
2010|175|R|   Do not flush medications down the toilet or pour them into a||
2010|176|R|drain unless instructed to do so. Properly discard this product||
2010|177|R|when it is expired or no longer needed. Consult your pharmacist||
2010|178|R|or local waste disposal company.||
2010|179|B|||
2010|180|M|MEDICAL ALERT:  Your condition can cause complications in a||
2010|181|M|medical emergency. For information about enrolling in MedicAlert,||
2010|182|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2010|183|B|||
2010|184|A|Information last revised November 2025.||
2010|185|A|Copyright(c) 2025 First Databank, Inc.||
2010|186|B|||
2014|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2014|002|Z|does NOT have all possible information about this product. This||
2014|003|Z|information does not assure that this product is safe, effective,||
2014|004|Z|or appropriate for you. This information is not individual||
2014|005|Z|medical advice and does not substitute for the advice of your||
2014|006|Z|health care professional. Always ask your health care||
2014|007|Z|professional for complete information about this product and your||
2014|008|Z|specific health needs.||
2014|009|B|||
2014|010|T|BENZHYDROCODONE/ACETAMINOPHEN - ORAL||
2014|011|F|(BENZ-hye-droe-KOE-done/a-SEET-a-MIN-oh-fen)||
2014|012|B|||
2014|013|C|COMMON BRAND NAME(S): Apadaz||
2014|014|B|||
2014|015|W|WARNING:  Benzhydrocodone/acetaminophen has a risk for abuse and||
2014|016|W|addiction, which can lead to overdose and death.||
2014|017|W|Benzhydrocodone/acetaminophen may also cause severe, possibly||
2014|018|W|fatal, breathing problems. To lower your risk, your doctor should||
2014|019|W|have you take the smallest dose of benzhydrocodone/acetaminophen||
2014|020|W|that works, and take it for the shortest possible time. See also||
2014|021|W|How to Use section for more information about addiction.||
2014|022|W|   Ask your doctor or pharmacist if you should have medication||
2014|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
2014|024|W|Teach your family or household members about the signs of an||
2014|025|W|opioid overdose and how to treat it.||
2014|026|W|   The risk for severe breathing problems is higher when you||
2014|027|W|start this medication and after a dose increase, or if you take||
2014|028|W|the wrong dose/strength. Taking this medication with alcohol or||
2014|029|W|other drugs that can cause drowsiness or breathing problems may||
2014|030|W|cause very serious side effects, including death. Also, other||
2014|031|W|medications can affect the removal of||
2014|032|W|benzhydrocodone/acetaminophen from your body, which may affect||
2014|033|W|how benzhydrocodone/acetaminophen works. Be sure you know how to||
2014|034|W|take benzhydrocodone/acetaminophen and what other drugs you||
2014|035|W|should avoid taking with it. See also Drug Interactions section.||
2014|036|W|Get medical help right away if any of these very serious side||
2014|037|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
2014|038|W|severe drowsiness/dizziness, difficulty waking up.||
2014|039|W|   Keep this medicine in a safe place to prevent theft, misuse,||
2014|040|W|or abuse. If someone accidentally swallows this drug, get medical||
2014|041|W|help right away.||
2014|042|W|   One ingredient in this product is acetaminophen. Taking too||
2014|043|W|much acetaminophen may cause serious (possibly fatal) liver||
2014|044|W|disease. Adults should not take more than 4000 milligrams (4||
2014|045|W|grams) of acetaminophen a day. People with liver problems and||
2014|046|W|children should take less acetaminophen. Ask your doctor or||
2014|047|W|pharmacist how much acetaminophen is safe to take.||
2014|048|W|   Do not use with any other drug containing acetaminophen||
2014|049|W|without asking your doctor or pharmacist first. Acetaminophen is||
2014|050|W|in many nonprescription and prescription medications (such as||
2014|051|W|pain/fever drugs or cough-and-cold products). Check the labels on||
2014|052|W|all your medicines to see if they contain acetaminophen, and ask||
2014|053|W|your pharmacist if you are unsure.||
2014|054|W|   Get medical help right away if you take too much acetaminophen||
2014|055|W|(overdose), even if you feel well. Overdose symptoms may include||
2014|056|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
2014|057|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
2014|058|W|   Daily alcohol use, especially when combined with||
2014|059|W|acetaminophen, may damage your liver. Avoid alcohol.||
2014|060|W|   Before using this medication, women of childbearing age should||
2014|061|W|talk with their doctor(s) about the risks and benefits. Tell your||
2014|062|W|doctor if you are pregnant or if you plan to become pregnant.||
2014|063|W|During pregnancy, this medication should be used only when||
2014|064|W|clearly needed. It may slightly increase the risk of birth||
2014|065|W|defects if used during the first two months of pregnancy. Also,||
2014|066|W|using it for a long time or in high doses near the expected||
2014|067|W|delivery date may harm the unborn baby. To lessen the risk, take||
2014|068|W|the smallest effective dose for the shortest possible time.||
2014|069|W|Babies born to mothers who use this drug for a long time may||
2014|070|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
2014|071|W|doctor right away if you notice any symptoms in your newborn baby||
2014|072|W|such as crying that doesn't stop, slow/shallow breathing,||
2014|073|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
2014|074|W|difficulty gaining weight.||
2014|075|B|||
2014|076|U|USES:  This combination medication is for short-term use (no more||
2014|077|U|than 14 days) to help relieve moderate to severe pain. It||
2014|078|U|contains an opioid pain reliever (benzhydrocodone) and a||
2014|079|U|non-opioid pain reliever (acetaminophen). Benzhydrocodone works||
2014|080|U|in the brain to change how your body feels and responds to pain.||
2014|081|U|Acetaminophen can also reduce a fever.||
2014|082|B|||
2014|083|H|HOW TO USE:  See also Warning section.||
2014|084|H|   Read the Medication Guide provided by your pharmacist before||
2014|085|H|you start taking this medication and each time you get a refill.||
2014|086|H|If you have any questions, ask your doctor or pharmacist.||
2014|087|H|   Take this medication by mouth as directed by your doctor,||
2014|088|H|usually every 4 to 6 hours as needed. You may take this drug with||
2014|089|H|or without food. If you have nausea, it may help to take this||
2014|090|H|drug with food. Ask your doctor or pharmacist about other ways to||
2014|091|H|decrease nausea (such as lying down for 1 to 2 hours with as||
2014|092|H|little head movement as possible).||
2014|093|H|   The dosage is based on your medical condition and response to||
2014|094|H|treatment. Do not increase your dose or use this drug more often||
2014|095|H|or for longer than prescribed, because your risk of side effects||
2014|096|H|may increase. Properly stop the medication when so directed.||
2014|097|H|   Pain medications work best if they are used as the first signs||
2014|098|H|of pain occur. If you wait until the pain has worsened, the||
2014|099|H|medication may not work as well.||
2014|100|H|   If you have ongoing pain (such as due to cancer), your doctor||
2014|101|H|may direct you to also take long-acting opioid medications. In||
2014|102|H|that case, this medication might be used for sudden||
2014|103|H|(breakthrough) pain only as needed. Other pain relievers (such as||
2014|104|H|ibuprofen, naproxen) may also be prescribed. Ask your doctor or||
2014|105|H|pharmacist about using this product safely with other drugs.||
2014|106|H|   Suddenly stopping this medication may cause withdrawal,||
2014|107|H|especially if you have used it for a long time or in high doses.||
2014|108|H|To prevent withdrawal, your doctor may lower your dose slowly.||
2014|109|H|Tell your doctor or pharmacist right away if you have any||
2014|110|H|withdrawal symptoms such as restlessness, mental/mood changes||
2014|111|H|(including anxiety, trouble sleeping, thoughts of suicide),||
2014|112|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
2014|113|H|aches, or sudden changes in behavior.||
2014|114|H|   If this medication is used for a long time, it may not work as||
2014|115|H|well. Talk with your doctor if this medication stops working||
2014|116|H|well.||
2014|117|H|   Though it helps many people, this medication may sometimes||
2014|118|H|cause addiction. This risk may be higher if you have a||
2014|119|H|mental/mood disorder or a substance use disorder (such as overuse||
2014|120|H|of or addiction to drugs/alcohol). Take this medication exactly||
2014|121|H|as prescribed to lower the risk of addiction. Ask your doctor or||
2014|122|H|pharmacist for more details.||
2014|123|H|   Tell your doctor if your pain does not get better or if it||
2014|124|H|gets worse, or if you have any new pain.||
2014|125|B|||
2014|126|S|SIDE EFFECTS:  See also Warning section.||
2014|127|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
2014|128|S|drowsiness may occur. Some of these side effects may decrease||
2014|129|S|after you have been using this medication for a while. If any of||
2014|130|S|these effects last or get worse, tell your doctor or pharmacist||
2014|131|S|promptly.||
2014|132|S|   To prevent constipation, eat dietary fiber, drink enough||
2014|133|S|water, and exercise. You may also need to take a laxative. Ask||
2014|134|S|your pharmacist which type of laxative is right for you.||
2014|135|S|   To reduce the risk of dizziness and lightheadedness, get up||
2014|136|S|slowly when rising from a sitting or lying position.||
2014|137|S|   Remember that this medication has been prescribed because your||
2014|138|S|doctor has judged that the benefit to you is greater than the||
2014|139|S|risk of side effects. Many people using this medication do not||
2014|140|S|have serious side effects.||
2014|141|S|   Tell your doctor right away if you have any serious side||
2014|142|S|effects, including: interrupted breathing during sleep (sleep||
2014|143|S|apnea), mental/mood changes (such as agitation, confusion,||
2014|144|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
2014|145|S|signs of your adrenal glands not working well (such as loss of||
2014|146|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
2014|147|S|   Get medical help right away if you have any very serious side||
2014|148|S|effects, including: fainting, seizure, slow/shallow breathing,||
2014|149|S|severe drowsiness/difficulty waking up.||
2014|150|S|   A very serious allergic reaction to this drug is rare.||
2014|151|S|However, get medical help right away if you notice any symptoms||
2014|152|S|of a serious allergic reaction, including: rash, itching/swelling||
2014|153|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2014|154|S|breathing.||
2014|155|S|   This is not a complete list of possible side effects. If you||
2014|156|S|notice other effects not listed above, contact your doctor or||
2014|157|S|pharmacist.||
2014|158|S|   In the US -||
2014|159|S|   Call your doctor for medical advice about side effects. You||
2014|160|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2014|161|S|www.fda.gov/medwatch.||
2014|162|S|   In Canada - Call your doctor for medical advice about side||
2014|163|S|effects. You may report side effects to Health Canada at||
2014|164|S|1-866-234-2345.||
2014|165|B|||
2014|166|P|PRECAUTIONS:  See also Warning section.||
2014|167|P|   Before taking this medication, tell your doctor or pharmacist||
2014|168|P|if you are allergic to it; or to other opioids (such as||
2014|169|P|hydrocodone, hydromorphone, morphine, codeine); or if you have||
2014|170|P|any other allergies. This product may contain inactive||
2014|171|P|ingredients, which can cause allergic reactions or other||
2014|172|P|problems. Talk to your pharmacist for more details.||
2014|173|P|   Before using this medication, tell your doctor or pharmacist||
2014|174|P|your medical history, especially of: brain disorders (such as||
2014|175|P|head injury, tumor, seizures), breathing problems (such as||
2014|176|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
2014|177|P|kidney disease, liver disease, mental/mood disorders (such as||
2014|178|P|confusion, depression, thoughts of suicide), personal or family||
2014|179|P|history of a substance use disorder (such as overuse of or||
2014|180|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
2014|181|P|blockage, constipation, diarrhea due to infection, paralytic||
2014|182|P|ileus), difficulty urinating (such as due to enlarged prostate),||
2014|183|P|gallbladder disease, disease of the pancreas (pancreatitis).||
2014|184|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2014|185|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2014|186|P|machinery, or do anything that needs alertness until you can do||
2014|187|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2014|188|P|are using marijuana (cannabis).||
2014|189|P|   Before having surgery, tell your doctor or dentist about all||
2014|190|P|the products you use (including prescription drugs,||
2014|191|P|nonprescription drugs, and herbal products).||
2014|192|P|   Children may be more sensitive to the side effects of this||
2014|193|P|drug, especially slow/shallow breathing.||
2014|194|P|   Older adults may be more sensitive to the side effects of this||
2014|195|P|drug, especially confusion, dizziness, drowsiness, and||
2014|196|P|slow/shallow breathing.||
2014|197|P|   During pregnancy, this medication should be used only when||
2014|198|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2014|199|P|benefits with your doctor.||
2014|200|P|   This medication passes into breast milk and may have||
2014|201|P|undesirable effects on a nursing infant. Tell the doctor right||
2014|202|P|away if your baby develops unusual sleepiness, difficulty||
2014|203|P|feeding, or trouble breathing. Consult your doctor before||
2014|204|P|breastfeeding.||
2014|205|B|||
2014|206|I|DRUG INTERACTIONS:  See also Warning section.||
2014|207|I|   Drug interactions may change how your medications work or||
2014|208|I|increase your risk for serious side effects. This document does||
2014|209|I|not contain all possible drug interactions. Keep a list of all||
2014|210|I|the products you use (including prescription/nonprescription||
2014|211|I|drugs and herbal products) and share it with your doctor and||
2014|212|I|pharmacist. Do not start, stop, or change the dosage of any||
2014|213|I|medicines without your doctor's approval.||
2014|214|I|   Some products that may interact with this drug are: certain||
2014|215|I|pain medications (mixed opioid agonist/antagonists such as||
2014|216|I|butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.||
2014|217|I|   The risk of serious side effects (such as slow/shallow||
2014|218|I|breathing, severe drowsiness/dizziness) may be increased if this||
2014|219|I|medication is taken with other products that may also cause||
2014|220|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2014|221|I|if you are taking other products such as other opioid pain or||
2014|222|I|cough relievers (such as codeine, hydrocodone, oxycodone),||
2014|223|I|alcohol, marijuana (cannabis), drugs for sleep or anxiety (such||
2014|224|I|as alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2014|225|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2014|226|I|cetirizine, diphenhydramine).||
2014|227|I|   Check the labels on all your medicines (such as allergy or||
2014|228|I|cough-and-cold products) because they may contain ingredients||
2014|229|I|that cause drowsiness. Ask your pharmacist about using those||
2014|230|I|products safely.||
2014|231|I|   Other medications can affect the removal of||
2014|232|I|benzhydrocodone/acetaminophen from your body, which may affect||
2014|233|I|how benzhydrocodone/acetaminophen works. Examples include azole||
2014|234|I|antifungals (such as ketoconazole), levoketoconazole, macrolide||
2014|235|I|antibiotics (such as erythromycin), mifepristone, HIV medications||
2014|236|I|(such as tipranavir), rifamycins (such as rifabutin, rifampin),||
2014|237|I|ritonavir, certain drugs used to treat seizures (such as||
2014|238|I|carbamazepine, phenytoin), among others.||
2014|239|I|   This medication may interfere with certain lab tests (such as||
2014|240|I|amylase/lipase levels), possibly causing false test results. Make||
2014|241|I|sure lab personnel and all your doctors know you use this drug.||
2014|242|B|||
2014|243|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2014|244|O|as passing out or trouble breathing, give them naloxone or||
2014|245|O|nalmefene if available, then call 911. If the person is awake and||
2014|246|O|has no symptoms, call a poison control center right away. US||
2014|247|O|residents can call 1-800-222-1222. Canada residents can call||
2014|248|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
2014|249|O|breathing, nausea, vomiting, loss of appetite, sweating,||
2014|250|O|stomach/abdominal pain, extreme tiredness, slow heartbeat,||
2014|251|O|yellowing eyes/skin, dark urine, coma.||
2014|252|B|||
2014|253|N|NOTES:  Do not share this medication with others. Sharing it is||
2014|254|N|against the law.||
2014|255|N|   This medication has been prescribed for your current condition||
2014|256|N|only. Do not use it later for another condition unless your||
2014|257|N|doctor tells you to. A different medication may be necessary in||
2014|258|N|that case.||
2014|259|B|||
2014|260|D|MISSED DOSE:  If you are taking this product on a regular||
2014|261|D|schedule and miss a dose, take it as soon as you remember. If it||
2014|262|D|is near the time of the next dose, skip the missed dose. Take||
2014|263|D|your next dose at the regular time. Do not double the dose to||
2014|264|D|catch up.||
2014|265|B|||
2014|266|R|STORAGE:  Store at room temperature away from light and moisture.||
2014|267|R|Do not store in the bathroom. Keep all medications away from||
2014|268|R|children and pets.||
2014|269|R|   Do not flush medications down the toilet or pour them into a||
2014|270|R|drain unless instructed to do so. Properly discard this product||
2014|271|R|when it is expired or no longer needed. For more details, read||
2014|272|R|the Medication Guide, or consult your pharmacist or local waste||
2014|273|R|disposal company.||
2014|274|B|||
2014|275|A|Information last revised August 2025.||
2014|276|A|Copyright(c) 2025 First Databank, Inc.||
2014|277|B|||
2016|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2016|002|Z|does NOT have all possible information about this product. This||
2016|003|Z|information does not assure that this product is safe, effective,||
2016|004|Z|or appropriate for you. This information is not individual||
2016|005|Z|medical advice and does not substitute for the advice of your||
2016|006|Z|health care professional. Always ask your health care||
2016|007|Z|professional for complete information about this product and your||
2016|008|Z|specific health needs.||
2016|009|B|||
2016|010|T|SEMAGLUTIDE - INJECTION||
2016|011|F|(SEM-a-GLOO-tide)||
2016|012|B|||
2016|013|C|COMMON BRAND NAME(S): Wegovy||
2016|014|B|||
2016|015|W|WARNING:  This medication has been found to cause a certain type||
2016|016|W|of thyroid tumor (thyroid C-cell tumors) in rats and mice. It is||
2016|017|W|unknown if this medication can cause similar tumors in humans.||
2016|018|W|Talk with your doctor about the benefits and risks of treatment||
2016|019|W|with this medication. This medication should not be used by||
2016|020|W|people with a personal/family history of a certain type of cancer||
2016|021|W|(medullary thyroid carcinoma) or by people with a certain||
2016|022|W|inherited disease (Multiple Endocrine Neoplasia syndrome type 2||
2016|023|W|or MEN 2). While using this medication, tell your doctor right||
2016|024|W|away if you notice any signs or symptoms of thyroid tumors,||
2016|025|W|including unusual growth or lump in the neck, difficulty||
2016|026|W|swallowing, shortness of breath, or unusual/lasting hoarseness.||
2016|027|B|||
2016|028|U|USES:  Semaglutide is used to lower the risk of death from heart||
2016|029|U|attack and stroke in people with heart disease who are overweight||
2016|030|U|or obese. It is also used by certain overweight people (such as||
2016|031|U|those who are obese or have weight-related medical problems) to||
2016|032|U|help lose weight. Semaglutide is used along with a||
2016|033|U|doctor-approved exercise, behavior change, and reduced-calorie||
2016|034|U|diet program. Losing weight and keeping it off can lessen the||
2016|035|U|many health risks of being overweight, including heart disease,||
2016|036|U|diabetes, high blood pressure, and a shorter life. Semaglutide is||
2016|037|U|similar to a natural hormone in your body (incretin). It works by||
2016|038|U|controlling your appetite.||
2016|039|U|   Semaglutide is also used to treat a certain type of liver||
2016|040|U|disease (metabolic dysfunction-associated steatohepatitis). It||
2016|041|U|may help improve liver function.||
2016|042|B|||
2016|043|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2016|044|H|provided by your pharmacist before you start using semaglutide||
2016|045|H|and each time you get a refill. Ask your health care professional||
2016|046|H|how to prepare and use this medication. If you have questions,||
2016|047|H|ask your doctor or pharmacist.||
2016|048|H|   Inject this medication under the skin as directed by your||
2016|049|H|doctor, usually once weekly. The injection is given in the thigh,||
2016|050|H|abdomen, or upper arm. It may be used with or without food. The||
2016|051|H|dosage is based on your medical condition and response to||
2016|052|H|treatment. Your doctor will start you on a low dose first to||
2016|053|H|decrease your risk of stomach/abdominal side effects, and||
2016|054|H|gradually increase your dose. Follow your doctor's instructions||
2016|055|H|carefully.||
2016|056|H|   Before using, check this product for particles or||
2016|057|H|discoloration. If either is present, do not use the liquid.||
2016|058|H|Before injecting each dose, clean the skin you are going to||
2016|059|H|inject into (the injection site) with rubbing alcohol. Change the||
2016|060|H|injection site each time to lessen injury under the skin. Do not||
2016|061|H|inject into skin that is tender, bruised, red, hard, or has scars||
2016|062|H|or stretch marks. To lessen bruising, do not rub the injection||
2016|063|H|site after a shot. Learn how to store and discard medical||
2016|064|H|supplies safely.||
2016|065|H|   Use this medication regularly to get the most benefit from it.||
2016|066|H|To help you remember, use it on the same day and time each week.||
2016|067|H|Mark your calendar with a reminder. Carefully follow the meal||
2016|068|H|plan and exercise program your doctor has recommended.||
2016|069|B|||
2016|070|S|SIDE EFFECTS:  See also Warning section.||
2016|071|S|   Nausea, vomiting, stomach upset, diarrhea, tiredness,||
2016|072|S|dizziness, or constipation may occur. Nausea usually lessens as||
2016|073|S|you continue to use semaglutide. If any of these effects last or||
2016|074|S|get worse, tell your doctor or pharmacist promptly.||
2016|075|S|   Remember that this medication has been prescribed because your||
2016|076|S|doctor has judged that the benefit to you is greater than the||
2016|077|S|risk of side effects. Many people using this medication do not||
2016|078|S|have serious side effects.||
2016|079|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2016|080|S|Contact your doctor promptly if you notice any symptoms of||
2016|081|S|dehydration, such as unusual dry mouth/thirst or||
2016|082|S|dizziness/lightheadedness.||
2016|083|S|   Tell your doctor right away if you have any serious side||
2016|084|S|effects, including: signs of kidney problems (such as change in||
2016|085|S|the amount of urine), vision changes (such as decreased/blurred||
2016|086|S|vision), fast heartbeat, mental/mood changes (such as depression,||
2016|087|S|thoughts of suicide), signs of low blood sugar (sudden sweating,||
2016|088|S|shaking, fast heartbeat, hunger, blurred vision, dizziness,||
2016|089|S|tingling hands/feet).||
2016|090|S|   Get medical help right away if you have any very serious side||
2016|091|S|effects, including: signs of pancreas or gallbladder disease||
2016|092|S|(such as nausea/vomiting that doesn't stop, severe||
2016|093|S|stomach/abdominal pain).||
2016|094|S|   A very serious allergic reaction to this drug is rare.||
2016|095|S|However, get medical help right away if you notice any symptoms||
2016|096|S|of a serious allergic reaction, including: rash, itching/swelling||
2016|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2016|098|S|breathing.||
2016|099|S|   This is not a complete list of possible side effects. If you||
2016|100|S|notice other effects not listed above, contact your doctor or||
2016|101|S|pharmacist.||
2016|102|S|   In the US -||
2016|103|S|   Call your doctor for medical advice about side effects. You||
2016|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2016|105|S|www.fda.gov/medwatch.||
2016|106|S|   In Canada - Call your doctor for medical advice about side||
2016|107|S|effects. You may report side effects to Health Canada at||
2016|108|S|1-866-234-2345.||
2016|109|B|||
2016|110|P|PRECAUTIONS:  See also Warning section.||
2016|111|P|   Before using semaglutide, tell your doctor or pharmacist if||
2016|112|P|you are allergic to it; or if you have any other allergies. This||
2016|113|P|product may contain inactive ingredients, which can cause||
2016|114|P|allergic reactions or other problems. Talk to your pharmacist for||
2016|115|P|more details.||
2016|116|P|   Before using this medication, tell your doctor or pharmacist||
2016|117|P|your medical history, especially of: kidney disease, gallbladder||
2016|118|P|disease, disease of the pancreas (pancreatitis), a certain eye||
2016|119|P|problem (diabetic retinopathy), mental/mood disorders (such as||
2016|120|P|depression, thoughts of suicide), certain stomach/intestinal||
2016|121|P|disorders (gastroparesis, problems digesting food).||
2016|122|P|   If you have diabetes, this product may affect your blood||
2016|123|P|sugar. Check your blood sugar regularly as directed and share the||
2016|124|P|results with your doctor. Tell your doctor right away if you have||
2016|125|P|symptoms of low blood sugar (see Side Effects section). Your||
2016|126|P|doctor may need to adjust your diabetes medication(s), exercise||
2016|127|P|program, or diet.||
2016|128|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2016|129|P|can make you more dizzy. Do not drive, use machinery, or do||
2016|130|P|anything that needs alertness until you can do it safely. Limit||
2016|131|P|alcoholic beverages. Talk to your doctor if you are using||
2016|132|P|marijuana (cannabis).||
2016|133|P|   Before having surgery, tell your doctor or dentist about all||
2016|134|P|the products you use (including prescription drugs,||
2016|135|P|nonprescription drugs, and herbal products).||
2016|136|P|   Children may be at greater risk for gallbladder disease, rash,||
2016|137|P|and low blood pressure while using this drug.||
2016|138|P|   Tell your doctor if you are pregnant or plan to become||
2016|139|P|pregnant. You should not become pregnant while using semaglutide||
2016|140|P|and for 2 months after the last dose. Semaglutide may harm an||
2016|141|P|unborn baby. If you become pregnant, talk to your doctor right||
2016|142|P|away about the risks and benefits of this medication.||
2016|143|P|   It is unknown if this medication passes into breast milk.||
2016|144|P|Consult your doctor before breastfeeding.||
2016|145|B|||
2016|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2016|147|I|medications work or increase your risk for serious side effects.||
2016|148|I|This document does not contain all possible drug interactions.||
2016|149|I|Keep a list of all the products you use (including||
2016|150|I|prescription/nonprescription drugs and herbal products) and share||
2016|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
2016|152|I|the dosage of any medicines without your doctor's approval.||
2016|153|I|   Do not use this medication with any other product that||
2016|154|I|contains semaglutide or other medications which are similar to||
2016|155|I|this medication (such as exenatide, dulaglutide).||
2016|156|B|||
2016|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2016|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2016|159|O|poison control center right away. US residents can call||
2016|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2016|161|O|Symptoms of overdose may include: severe nausea/vomiting.||
2016|162|B|||
2016|163|N|NOTES:  Do not share this medication with others.||
2016|164|N|   Lab and/or medical tests (such as kidney function, blood||
2016|165|N|glucose, heartbeat, weight) should be done while you are using||
2016|166|N|this medication. Keep all medical and lab appointments. Consult||
2016|167|N|your doctor for more details.||
2016|168|B|||
2016|169|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2016|170|D|If it is less than 48 hours before the next dose, skip the missed||
2016|171|D|dose. Use your next dose at the regular time. Do not double the||
2016|172|D|dose to catch up. If you miss more than 2 doses in a row, ask||
2016|173|D|your doctor if you should restart the medication with a lower||
2016|174|D|dose to reduce your chance of side effects.||
2016|175|B|||
2016|176|R|STORAGE:  Different brands of this medication have different||
2016|177|R|storage needs. Check the product package for instructions on how||
2016|178|R|to store your brand, or ask your pharmacist. Keep all medications||
2016|179|R|away from children and pets.||
2016|180|R|   Do not flush medications down the toilet or pour them into a||
2016|181|R|drain unless instructed to do so. Properly discard this product||
2016|182|R|when it is expired or no longer needed. Consult your pharmacist||
2016|183|R|or local waste disposal company.||
2016|184|B|||
2016|185|A|Information last revised August 2025.||
2016|186|A|Copyright(c) 2025 First Databank, Inc.||
2016|187|B|||
2017|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2017|002|Z|does NOT have all possible information about this product. This||
2017|003|Z|information does not assure that this product is safe, effective,||
2017|004|Z|or appropriate for you. This information is not individual||
2017|005|Z|medical advice and does not substitute for the advice of your||
2017|006|Z|health care professional. Always ask your health care||
2017|007|Z|professional for complete information about this product and your||
2017|008|Z|specific health needs.||
2017|009|B|||
2017|010|T|LEVODOPA POWDER IN CAPSULE - ORAL INHALATION||
2017|011|F|(LEE-voe-DOE-pa)||
2017|012|B|||
2017|013|C|COMMON BRAND NAME(S): Inbrija||
2017|014|B|||
2017|015|U|USES:  This medication is used when needed to treat the return of||
2017|016|U|Parkinson's symptoms (known as OFF episodes) in people with||
2017|017|U|Parkinson's disease who are treated with carbidopa/levodopa||
2017|018|U|medicines. Parkinson's disease tends to worsen over time, and you||
2017|019|U|may need extra levodopa from time to time to keep symptoms (such||
2017|020|U|as shakiness, stiffness, difficulty moving) from returning. This||
2017|021|U|medication does not replace your regular carbidopa/levodopa||
2017|022|U|medicine. Keep taking your carbidopa/levodopa medicine regularly||
2017|023|U|as directed by your doctor.||
2017|024|U|   Parkinson's disease is thought to be caused by too little of a||
2017|025|U|naturally occurring substance (dopamine) in the brain. Levodopa||
2017|026|U|changes into dopamine in the brain, helping to control movement.||
2017|027|B|||
2017|028|H|HOW TO USE:  Read the Patient Information Leaflet and||
2017|029|H|Instructions for Use provided by your pharmacist before you start||
2017|030|H|using levodopa inhalation powder and each time you get a refill.||
2017|031|H|Learn how to use the inhaler properly. If you have any questions,||
2017|032|H|ask your doctor or pharmacist.||
2017|033|H|   Do not swallow the capsules. Use the special inhaler to inhale||
2017|034|H|the powder in the capsules. Inhale this medication by mouth as||
2017|035|H|directed by your doctor, when symptoms of an OFF period start.||
2017|036|H|Each dose is 2 of the 42-milligram capsules. Make sure your hands||
2017|037|H|are clean and dry before preparing your dose. Load one capsule in||
2017|038|H|the inhaler and breathe out completely, holding the inhaler level||
2017|039|H|and away from your mouth. While keeping the inhaler level, close||
2017|040|H|your lips firmly around the mouthpiece and take a deep,||
2017|041|H|comfortable breath. You should hear and feel the capsule "whirl"||
2017|042|H|(spin) as you breathe in. Take the inhaler out of your mouth and||
2017|043|H|hold your breath for 5 seconds, then breathe out. Remove the used||
2017|044|H|capsule from the inhaler. Repeat with a second capsule to finish||
2017|045|H|a full dose. Take used capsules out of the inhaler before storing||
2017|046|H|the inhaler. Do not store unused capsules in the inhaler for a||
2017|047|H|future dose.||
2017|048|H|   The dosage is based on your medical condition and response to||
2017|049|H|treatment. Do not use more than 1 dose per OFF period. Do not use||
2017|050|H|more than 5 doses in one day.||
2017|051|H|   Tell your doctor if your condition does not get better or if||
2017|052|H|it gets worse.||
2017|053|B|||
2017|054|S|SIDE EFFECTS:  Coughing or a feeling of choking may occur during||
2017|055|S|or after using a dose. Dizziness, lightheadedness, nausea,||
2017|056|S|trouble sleeping, unusual dreams, stuffy/runny nose, sore throat,||
2017|057|S|or fever may also occur. If any of these effects last or get||
2017|058|S|worse, tell your doctor or pharmacist promptly.||
2017|059|S|   This medication may cause saliva or nasal discharge to turn a||
2017|060|S|dark color. This effect is harmless, but your clothes may be||
2017|061|S|stained.||
2017|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
2017|063|S|slowly when rising from a sitting or lying position.||
2017|064|S|   Remember that this medication has been prescribed because your||
2017|065|S|doctor has judged that the benefit to you is greater than the||
2017|066|S|risk of side effects. Many people using this medication do not||
2017|067|S|have serious side effects.||
2017|068|S|   Some people using this medication have fallen asleep suddenly||
2017|069|S|during their usual daily activities (such as talking on the||
2017|070|S|phone, driving). In some cases, sleep occurred without any||
2017|071|S|feelings of drowsiness beforehand. This sleep effect may occur||
2017|072|S|anytime during treatment with levodopa even if you have used this||
2017|073|S|medication for a long time. If you experience increased||
2017|074|S|sleepiness or fall asleep during the day, do not drive or do||
2017|075|S|other possibly dangerous activities until you have discussed this||
2017|076|S|effect with your doctor. Your risk of this sleep effect is||
2017|077|S|increased by using alcohol or other medications that can make you||
2017|078|S|drowsy. See also Precautions section.||
2017|079|S|   Tell your doctor right away if you have any serious side||
2017|080|S|effects, including: new/worsening movements you can't||
2017|081|S|control/spasms, greatly increased eye blinking/twitching, vision||
2017|082|S|changes (such as blurred vision, double vision), eye pain, severe||
2017|083|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
2017|084|S|coffee grounds, mental/mood changes (such as agitation,||
2017|085|S|hallucinations, depression, thoughts of suicide), signs of||
2017|086|S|infection (such as sore throat that doesn't go away, fever,||
2017|087|S|chills), easy bleeding/bruising, unusual tiredness, tingling of||
2017|088|S|the hands/feet, unusual strong urges (such as increased gambling,||
2017|089|S|increased sexual urges).||
2017|090|S|   Get medical help right away if you have any very serious side||
2017|091|S|effects, including: chest pain, fainting.||
2017|092|S|   Suddenly stopping or reducing the dose of this medication may||
2017|093|S|rarely cause a very serious condition called neuroleptic||
2017|094|S|malignant syndrome (NMS). Get medical help right away if you have||
2017|095|S|any of the following symptoms: fever, unusual muscle stiffness,||
2017|096|S|severe confusion, sweating, fast/irregular heartbeat.||
2017|097|S|   A very serious allergic reaction to this drug is rare.||
2017|098|S|However, get medical help right away if you notice any symptoms||
2017|099|S|of a serious allergic reaction, including: rash, itching/swelling||
2017|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2017|101|S|breathing.||
2017|102|S|   This is not a complete list of possible side effects. If you||
2017|103|S|notice other effects not listed above, contact your doctor or||
2017|104|S|pharmacist.||
2017|105|S|   In the US -||
2017|106|S|   Call your doctor for medical advice about side effects. You||
2017|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2017|108|S|www.fda.gov/medwatch.||
2017|109|S|   In Canada - Call your doctor for medical advice about side||
2017|110|S|effects. You may report side effects to Health Canada at||
2017|111|S|1-866-234-2345.||
2017|112|B|||
2017|113|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2017|114|P|pharmacist if you are allergic to levodopa; or to foslevodopa; or||
2017|115|P|if you have any other allergies. This product may contain||
2017|116|P|inactive ingredients, which can cause allergic reactions or other||
2017|117|P|problems. Talk to your pharmacist for more details.||
2017|118|P|   Before using this medication, tell your doctor or pharmacist||
2017|119|P|your medical history, especially of: liver disease, glaucoma,||
2017|120|P|breathing problems (such as asthma, chronic obstructive pulmonary||
2017|121|P|disease-COPD), heart disease (such as heart attack, irregular||
2017|122|P|heartbeat), kidney disease, stomach/intestinal ulcer, mental/mood||
2017|123|P|disorders (such as depression, schizophrenia), blood disorders,||
2017|124|P|seizures, sleep disorders.||
2017|125|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2017|126|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2017|127|P|machinery, or do anything that needs alertness until you can do||
2017|128|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2017|129|P|are using marijuana (cannabis). See also Side Effects section.||
2017|130|P|   Before having surgery, tell your doctor or dentist about all||
2017|131|P|the products you use (including prescription drugs,||
2017|132|P|nonprescription drugs, and herbal products).||
2017|133|P|   Older adults may be more sensitive to the side effects of this||
2017|134|P|drug, especially cough, stuffy/runny nose, sore throat, or fever.||
2017|135|P|   During pregnancy, this medication should be used only when||
2017|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
2017|137|P|   Levodopa passes into breast milk. Consult your doctor before||
2017|138|P|breastfeeding.||
2017|139|B|||
2017|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2017|141|I|medications work or increase your risk for serious side effects.||
2017|142|I|This document does not contain all possible drug interactions.||
2017|143|I|Keep a list of all the products you use (including||
2017|144|I|prescription/nonprescription drugs and herbal products) and share||
2017|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
2017|146|I|the dosage of any medicines without your doctor's approval.||
2017|147|I|   Taking MAO inhibitors with this medication may cause a serious||
2017|148|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2017|149|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2017|150|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
2017|151|I|treatment with this medication. Most MAO inhibitors should also||
2017|152|I|not be taken for two weeks before treatment with this medication.||
2017|153|I|However, certain MAO inhibitors (rasagiline, safinamide,||
2017|154|I|selegiline) may be used with careful monitoring by your doctor.||
2017|155|I|Ask your doctor when to start or stop using this medication.||
2017|156|I|   This medication may interfere with certain lab tests (such as||
2017|157|I|urine catecholamine/glucose/ketone tests), possibly causing false||
2017|158|I|test results. Make sure lab personnel and all your doctors know||
2017|159|I|you use this drug.||
2017|160|B|||
2017|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2017|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2017|163|O|poison control center right away. US residents can call||
2017|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2017|165|O|Symptoms of overdose may include: severe dizziness, irregular||
2017|166|O|heartbeat, mental/mood changes (such as agitation).||
2017|167|B|||
2017|168|N|NOTES:  Do not share this medication with others.||
2017|169|N|   Lab and/or medical tests (such as complete blood count,||
2017|170|N|heart/kidney/liver function, blood pressure) should be done while||
2017|171|N|you are using this medication. Keep all medical and lab||
2017|172|N|appointments.||
2017|173|B|||
2017|174|D|MISSED DOSE:  Not applicable.||
2017|175|B|||
2017|176|R|STORAGE:  Store at room temperature away from moisture. Keep the||
2017|177|R|capsules in the original packaging until ready to use. Do not||
2017|178|R|store in the bathroom. Keep all medications away from children||
2017|179|R|and pets.||
2017|180|R|   Do not flush medications down the toilet or pour them into a||
2017|181|R|drain unless instructed to do so. Properly discard this product||
2017|182|R|when it is expired or no longer needed. Consult your pharmacist||
2017|183|R|or local waste disposal company.||
2017|184|B|||
2017|185|A|Information last revised April 2025.||
2017|186|A|Copyright(c) 2025 First Databank, Inc.||
2017|187|B|||
2019|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2019|002|Z|does NOT have all possible information about this product. This||
2019|003|Z|information does not assure that this product is safe, effective,||
2019|004|Z|or appropriate for you. This information is not individual||
2019|005|Z|medical advice and does not substitute for the advice of your||
2019|006|Z|health care professional. Always ask your health care||
2019|007|Z|professional for complete information about this product and your||
2019|008|Z|specific health needs.||
2019|009|B|||
2019|010|T|ZONISAMIDE - ORAL||
2019|011|F|(zoh-NISS-uh-mide)||
2019|012|B|||
2019|013|C|COMMON BRAND NAME(S): Zonegran, Zonisade||
2019|014|B|||
2019|015|U|USES:  Zonisamide is used with other medications to prevent and||
2019|016|U|control seizures (epilepsy). Zonisamide is a sulfonamide||
2019|017|U|anticonvulsant and a carbonic anhydrase inhibitor. It is unknown||
2019|018|U|how zonisamide works to prevent seizures.||
2019|019|B|||
2019|020|H|HOW TO USE:  Read the Medication Guide provided by your||
2019|021|H|pharmacist before you start taking zonisamide and each time you||
2019|022|H|get a refill. If you have any questions, consult your doctor or||
2019|023|H|pharmacist.||
2019|024|H|   Take this medication by mouth with or without food as directed||
2019|025|H|by your doctor, usually 1 to 2 times a day. To prevent kidney||
2019|026|H|stones from forming, drink plenty of liquids while taking this||
2019|027|H|medication unless your doctor instructs you otherwise.||
2019|028|H|   If you are using the capsule form of this medication, swallow||
2019|029|H|the capsules whole.||
2019|030|H|   If you are using the liquid form of this medication, carefully||
2019|031|H|measure the dose using a special measuring device/spoon. Do not||
2019|032|H|use a household spoon because you may not get the correct dose.||
2019|033|H|Shake the bottle well before each dose.||
2019|034|H|   Dosage is based on your medical condition and response to||
2019|035|H|treatment. It is very important to follow your doctor's dosing||
2019|036|H|instructions exactly. Your doctor will start you on a low dose||
2019|037|H|and slowly increase your dose. It may take several weeks or||
2019|038|H|months to reach the best dose for you and to get the full benefit||
2019|039|H|from this medication.||
2019|040|H|   Use this medication regularly to get the most benefit from it.||
2019|041|H|This drug works best when the amount of medicine in your body is||
2019|042|H|kept at a constant level. To help you remember and to keep a||
2019|043|H|constant level, take zonisamide at the same time(s) each day.||
2019|044|H|   Do not stop taking this medication without consulting your||
2019|045|H|doctor. Some conditions may become worse when the drug is||
2019|046|H|suddenly stopped. Your dose may need to be gradually decreased.||
2019|047|H|   Tell your doctor if your condition does not get better or if||
2019|048|H|it gets worse.||
2019|049|B|||
2019|050|S|SIDE EFFECTS:  Dizziness, drowsiness, trouble sleeping, lack of||
2019|051|S|coordination, lightheadedness, loss of appetite, diarrhea, or||
2019|052|S|double vision may occur. If any of these effects last or get||
2019|053|S|worse, tell your doctor or pharmacist promptly.||
2019|054|S|   Remember that this medication has been prescribed because your||
2019|055|S|doctor has judged that the benefit to you is greater than the||
2019|056|S|risk of side effects. Many people using this medication do not||
2019|057|S|have serious side effects.||
2019|058|S|   Tell your doctor right away if you have any serious side||
2019|059|S|effects, including: mental/mood problems (such as confusion,||
2019|060|S|difficulty concentrating, memory problems, agitation,||
2019|061|S|irritability), speech problems, decreased sweating, sudden||
2019|062|S|back/side/abdominal pain, painful urination.||
2019|063|S|   A small number of people who take anticonvulsants for any||
2019|064|S|condition (such as seizure, bipolar disorder, pain) may||
2019|065|S|experience depression, suicidal thoughts/attempts, or other||
2019|066|S|mental/mood problems. Tell your doctor right away if you or your||
2019|067|S|family/caregiver notice any unusual/sudden changes in your mood,||
2019|068|S|thoughts, or behavior including signs of depression, suicidal||
2019|069|S|thoughts/attempts, thoughts about harming yourself.||
2019|070|S|   This medication may cause a serious metabolic problem||
2019|071|S|(metabolic acidosis). Get medical help right away if you have any||
2019|072|S|of the following symptoms: bone pain, rapid breathing,||
2019|073|S|fast/irregular heartbeat, sudden/unexplained tiredness, severe||
2019|074|S|drowsiness/difficulty staying awake.||
2019|075|S|   Get medical help right away if you have any very serious side||
2019|076|S|effects, such as: easy bruising/bleeding, eye pain/redness,||
2019|077|S|vision changes (such as decreased vision, blurred vision), signs||
2019|078|S|of kidney problems (such as change in the amount of urine,||
2019|079|S|pink/bloody urine), signs of liver problems (such as||
2019|080|S|nausea/vomiting that doesn't stop, loss of appetite,||
2019|081|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2019|082|S|   A very serious allergic reaction to this drug is rare.||
2019|083|S|However, get medical help right away if you notice any symptoms||
2019|084|S|of a serious allergic reaction, including: fever, swollen lymph||
2019|085|S|nodes, rash, itching/swelling (especially of the||
2019|086|S|face/tongue/throat), severe dizziness, trouble breathing.||
2019|087|S|   This is not a complete list of possible side effects. If you||
2019|088|S|notice other effects not listed above, contact your doctor or||
2019|089|S|pharmacist.||
2019|090|S|   In the US -||
2019|091|S|   Call your doctor for medical advice about side effects. You||
2019|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2019|093|S|www.fda.gov/medwatch.||
2019|094|S|   In Canada - Call your doctor for medical advice about side||
2019|095|S|effects. You may report side effects to Health Canada at||
2019|096|S|1-866-234-2345.||
2019|097|B|||
2019|098|P|PRECAUTIONS:  Before taking zonisamide, tell your doctor or||
2019|099|P|pharmacist if you are allergic to it; or if you have any other||
2019|100|P|allergies. This product may contain inactive ingredients, which||
2019|101|P|can cause allergic reactions or other problems. Talk to your||
2019|102|P|pharmacist for more details.||
2019|103|P|   Before using this medication, tell your doctor or pharmacist||
2019|104|P|your medical history, especially of: liver disease, kidney||
2019|105|P|disease (such as kidney stones), lung/breathing problems,||
2019|106|P|long-term diarrhea, metabolic imbalance (metabolic acidosis), a||
2019|107|P|special diet (ketogenic diet), mental/mood problems (such as||
2019|108|P|depression, psychosis).||
2019|109|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2019|110|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2019|111|P|machinery, or do anything that needs alertness until you can do||
2019|112|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2019|113|P|are using marijuana (cannabis).||
2019|114|P|   Before having surgery, tell your doctor or dentist about all||
2019|115|P|the products you use (including prescription drugs,||
2019|116|P|nonprescription drugs, and herbal products).||
2019|117|P|   This medication may make you sweat less, making you more||
2019|118|P|likely to get heat stroke. Avoid doing things that may cause you||
2019|119|P|to overheat, such as hard work or exercise in hot weather, or||
2019|120|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2019|121|P|and dress lightly. If you overheat, quickly look for a place to||
2019|122|P|cool down and rest. Get medical help right away if you have a||
2019|123|P|fever that does not go away, mental/mood changes, headache, or||
2019|124|P|dizziness.||
2019|125|P|   Older adults may be more sensitive to the side effects of this||
2019|126|P|drug, especially dizziness, lightheadedness, or lack of||
2019|127|P|coordination. These side effects can increase the risk of||
2019|128|P|falling.||
2019|129|P|   Children may be more sensitive to the side effects of the||
2019|130|P|drug, especially decreased sweating, heat stroke, or metabolic||
2019|131|P|imbalance.||
2019|132|P|   During pregnancy, this medication should be used only when||
2019|133|P|clearly needed. It may harm an unborn baby. Ask about reliable||
2019|134|P|forms of birth control while using this medication and for 1||
2019|135|P|month after the last dose. Since untreated seizures are a serious||
2019|136|P|condition that can harm both a pregnant woman and her unborn||
2019|137|P|baby, do not stop taking this medication unless directed by your||
2019|138|P|doctor. If you are planning pregnancy, become pregnant, or think||
2019|139|P|you may be pregnant, talk to your doctor right away about the||
2019|140|P|benefits and risks of using this medication during pregnancy.||
2019|141|P|   This medication passes into breast milk. Consult your doctor||
2019|142|P|before breastfeeding.||
2019|143|B|||
2019|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2019|145|I|medications work or increase your risk for serious side effects.||
2019|146|I|This document does not contain all possible drug interactions.||
2019|147|I|Keep a list of all the products you use (including||
2019|148|I|prescription/nonprescription drugs and herbal products) and share||
2019|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
2019|150|I|the dosage of any medicines without your doctor's approval.||
2019|151|I|   Some products that may interact with this drug include:||
2019|152|I|carbonic anhydrase inhibitors (such as acetazolamide), orlistat.||
2019|153|I|   Other medications can affect the removal of zonisamide from||
2019|154|I|your body, which may affect how zonisamide works. Examples||
2019|155|I|include other medications to treat seizures (such as||
2019|156|I|phenobarbital, primidone), rifamycins (such as rifabutin), St.||
2019|157|I|John's wort, among others. Your doctor may need to adjust your||
2019|158|I|dose of zonisamide if you are on these medications.||
2019|159|I|   Tell your doctor or pharmacist if you are taking other||
2019|160|I|products that cause drowsiness including alcohol, marijuana||
2019|161|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
2019|162|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
2019|163|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
2019|164|I|codeine).||
2019|165|I|   Check the labels on all your medicines (such as allergy or||
2019|166|I|cough-and-cold products) because they may contain ingredients||
2019|167|I|that cause drowsiness. Ask your pharmacist about using those||
2019|168|I|products safely.||
2019|169|B|||
2019|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2019|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2019|172|O|poison control center right away. US residents can call||
2019|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2019|174|O|Symptoms of overdose may include: slow/shallow breathing, severe||
2019|175|O|dizziness, loss of consciousness.||
2019|176|B|||
2019|177|N|NOTES:  Do not share this medication with others.||
2019|178|N|   Lab and/or medical tests (such as kidney function, bicarbonate||
2019|179|N|level, complete blood count) should be done while you are taking||
2019|180|N|this medication. Keep all medical and lab appointments. Consult||
2019|181|N|your doctor for more details.||
2019|182|B|||
2019|183|D|MISSED DOSE:  It is important to take each dose at the scheduled||
2019|184|D|time. If you miss a dose, take it as soon as you remember. If it||
2019|185|D|is near the time of the next dose, skip the missed dose. Take||
2019|186|D|your next dose at the regular time. Do not double the dose to||
2019|187|D|catch up.||
2019|188|B|||
2019|189|R|STORAGE:  Store at room temperature away from light and moisture.||
2019|190|R|Do not store in the bathroom. For the liquid form, once the||
2019|191|R|bottle is opened, the medication expires after 30 days. Keep all||
2019|192|R|medications away from children and pets.||
2019|193|R|   Do not flush medications down the toilet or pour them into a||
2019|194|R|drain unless instructed to do so. Properly discard this product||
2019|195|R|when it is expired or no longer needed. Consult your pharmacist||
2019|196|R|or local waste disposal company.||
2019|197|B|||
2019|198|M|MEDICAL ALERT:  Your condition can cause complications in a||
2019|199|M|medical emergency. For information about enrolling in MedicAlert,||
2019|200|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2019|201|B|||
2019|202|A|Information last revised October 2024.||
2019|203|A|Copyright(c) 2025 First Databank, Inc.||
2019|204|B|||
2020|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2020|002|Z|does NOT have all possible information about this product. This||
2020|003|Z|information does not assure that this product is safe, effective,||
2020|004|Z|or appropriate for you. This information is not individual||
2020|005|Z|medical advice and does not substitute for the advice of your||
2020|006|Z|health care professional. Always ask your health care||
2020|007|Z|professional for complete information about this product and your||
2020|008|Z|specific health needs.||
2020|009|B|||
2020|010|T|LEVOTHYROXINE SOLUTION - ORAL||
2020|011|F|(LEE-voe-thye-ROX-een)||
2020|012|B|||
2020|013|C|COMMON BRAND NAME(S): Ermeza, Thyquidity, Tirosint-Sol||
2020|014|B|||
2020|015|W|WARNING:  This medication should not be used for weight loss.||
2020|016|W|Normal doses of this medication will not work for weight loss,||
2020|017|W|and large doses of this medication may cause serious, possibly||
2020|018|W|fatal side effects, especially when taken with diet pills.||
2020|019|B|||
2020|020|U|USES:  Levothyroxine is used to treat an underactive thyroid||
2020|021|U|gland (hypothyroidism). It replaces or provides more thyroid||
2020|022|U|hormone, which is normally produced by the thyroid gland. Low||
2020|023|U|thyroid hormone levels can occur naturally or when the thyroid||
2020|024|U|gland is injured by radiation/medications or removed by surgery.||
2020|025|U|Having enough thyroid hormone is important for normal mental and||
2020|026|U|physical activity. In children, having enough thyroid hormone is||
2020|027|U|important for normal mental and physical development.||
2020|028|U|   This medication is also used to treat other types of thyroid||
2020|029|U|disorders (such as thyroid cancer).||
2020|030|U|   This medication should not be used to treat infertility unless||
2020|031|U|it is caused by low thyroid hormone levels.||
2020|032|B|||
2020|033|H|HOW TO USE:  Read the Patient Information Leaflet and||
2020|034|H|Instructions for Use if available from your pharmacist before you||
2020|035|H|start taking levothyroxine and each time you get a refill. If you||
2020|036|H|have any questions, ask your doctor or pharmacist.||
2020|037|H|   Take this medication by mouth as directed by your doctor,||
2020|038|H|usually once daily on an empty stomach, 30 minutes to 1 hour||
2020|039|H|before breakfast. Some brands may also be taken 15 minutes before||
2020|040|H|breakfast. Ask your pharmacist about your brand of levothyroxine.||
2020|041|H|   If you are using the medication that comes in a bottle,||
2020|042|H|carefully measure the dose using a special measuring||
2020|043|H|device/spoon. Do not use a household spoon because you may not||
2020|044|H|get the correct dose. Take the medication directly from the||
2020|045|H|measuring device. Do not mix with any other liquid.||
2020|046|H|   If you are using the medication that comes in an ampule, the||
2020|047|H|medication may be taken by first mixing it in water, or it may be||
2020|048|H|taken directly (without water). To take it by mixing in water,||
2020|049|H|open the ampule as directed. Then turn the ampule upside down and||
2020|050|H|slowly squeeze the soft (middle) part of the ampule to empty the||
2020|051|H|contents into a glass or cup of water. Release pressure and wait||
2020|052|H|a few seconds. Repeat squeezing and releasing the ampule at least||
2020|053|H|5 times, until no more liquid comes out of the ampule. Stir the||
2020|054|H|solution and drink all of the liquid right away. Rinse the glass||
2020|055|H|or cup with more water and drink to make sure you have taken all||
2020|056|H|the medicine. Do not prepare a supply ahead of time. To take this||
2020|057|H|medication directly, slowly squeeze the soft (middle) part of the||
2020|058|H|open ampule to empty the contents into the mouth or onto a spoon.||
2020|059|H|Release pressure and wait a few seconds. Repeat squeezing and||
2020|060|H|releasing the ampule at least 5 times, until no more liquid comes||
2020|061|H|out of the ampule. Take all of the liquid right away.||
2020|062|H|   The dosage is based on your age, weight, medical condition,||
2020|063|H|lab test results, response to treatment, and other medications||
2020|064|H|you may be taking. Be sure to tell your doctor and pharmacist||
2020|065|H|about all the products you use (including prescription drugs,||
2020|066|H|nonprescription drugs, and herbal products).||
2020|067|H|   Use this medication regularly to get the most benefit from it.||
2020|068|H|To help you remember, take it at the same time each day.||
2020|069|H|   Do not stop taking this medication without consulting your||
2020|070|H|doctor. Thyroid replacement treatment is usually taken for life.||
2020|071|H|   There are different brands of levothyroxine available. Do not||
2020|072|H|change brands without first consulting your doctor or pharmacist.||
2020|073|H|   Certain medications (such as cholestyramine, colestipol,||
2020|074|H|colesevelam, antacids, sucralfate, simethicone, iron, sodium||
2020|075|H|polystyrene sulfonate, calcium supplements, orlistat, sucroferric||
2020|076|H|oxyhydroxide, lanthanum, sevelamer, among others) can decrease||
2020|077|H|the amount of thyroid hormone that is absorbed by your body. If||
2020|078|H|you are taking any of these drugs, separate them from this||
2020|079|H|medication by at least 4 hours.||
2020|080|H|   Symptoms of low thyroid hormone levels include tiredness,||
2020|081|H|muscle aches, constipation, dry skin, weight gain, slow||
2020|082|H|heartbeat, or sensitivity to cold. Tell your doctor if your||
2020|083|H|condition does not get better or if it gets worse after several||
2020|084|H|weeks of taking this medication.||
2020|085|B|||
2020|086|S|SIDE EFFECTS:  See also Precautions section.||
2020|087|S|   Hair loss may occur during the first few months of treatment.||
2020|088|S|This effect is usually temporary as your body adjusts to this||
2020|089|S|medication. If this effect lasts or gets worse, tell your doctor||
2020|090|S|or pharmacist promptly.||
2020|091|S|   Remember that this medication has been prescribed because your||
2020|092|S|doctor has judged that the benefit to you is greater than the||
2020|093|S|risk of side effects. Many people using this medication do not||
2020|094|S|have serious side effects.||
2020|095|S|   Tell your doctor right away if you have any serious side||
2020|096|S|effects, including: increased sweating, sensitivity to heat,||
2020|097|S|mental/mood changes (such as nervousness, mood swings),||
2020|098|S|tiredness, diarrhea, shaking (tremor), headache, shortness of||
2020|099|S|breath, bone pain, easily broken bones.||
2020|100|S|   Get medical help right away if you have any very serious side||
2020|101|S|effects, including: chest pain, fast/pounding/irregular||
2020|102|S|heartbeat, swelling hands/ankles/feet, seizures.||
2020|103|S|   A very serious allergic reaction to this drug is rare.||
2020|104|S|However, get medical help right away if you notice any symptoms||
2020|105|S|of a serious allergic reaction, including: rash, itching/swelling||
2020|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2020|107|S|breathing.||
2020|108|S|   This is not a complete list of possible side effects. If you||
2020|109|S|notice other effects not listed above, contact your doctor or||
2020|110|S|pharmacist.||
2020|111|S|   In the US -||
2020|112|S|   Call your doctor for medical advice about side effects. You||
2020|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2020|114|S|www.fda.gov/medwatch.||
2020|115|S|   In Canada - Call your doctor for medical advice about side||
2020|116|S|effects. You may report side effects to Health Canada at||
2020|117|S|1-866-234-2345.||
2020|118|B|||
2020|119|P|PRECAUTIONS:  Before taking levothyroxine, tell your doctor or||
2020|120|P|pharmacist if you are allergic to it; or if you have any other||
2020|121|P|allergies. This product may contain inactive ingredients, which||
2020|122|P|can cause allergic reactions or other problems. Talk to your||
2020|123|P|pharmacist for more details.||
2020|124|P|   Before using this medication, tell your doctor or pharmacist||
2020|125|P|your medical history, especially of: increased thyroid hormones||
2020|126|P|(thyrotoxicosis), decreased adrenal gland function, heart disease||
2020|127|P|(such as coronary artery disease, irregular heartbeat), high||
2020|128|P|blood pressure, diabetes.||
2020|129|P|   If you have diabetes, this drug may affect your blood sugar.||
2020|130|P|Check your blood sugar regularly as directed and share the||
2020|131|P|results with your doctor. Tell your doctor right away if you have||
2020|132|P|symptoms such as increased thirst/urination, shakiness, unusual||
2020|133|P|sweating, dizziness, or hunger. Your doctor may need to adjust||
2020|134|P|your diabetes medication, exercise program, or diet.||
2020|135|P|   Before having surgery, tell your doctor or dentist about all||
2020|136|P|the products you use (including prescription drugs,||
2020|137|P|nonprescription drugs, and herbal products).||
2020|138|P|   Children may be more sensitive to certain side effects of this||
2020|139|P|drug, especially headache, vision changes, and hip/leg pain. High||
2020|140|P|thyroid hormone levels may lead to decreased bone||
2020|141|P|development/growth and reduced final adult height. Keep all||
2020|142|P|lab/medical appointments so the doctor can monitor treatment.||
2020|143|P|   Older adults may be more sensitive to the side effects of this||
2020|144|P|drug, especially fast/pounding/irregular heartbeat.||
2020|145|P|   This drug may be used during pregnancy. Tell your doctor if||
2020|146|P|you are pregnant because your doctor may need to change your||
2020|147|P|dose.||
2020|148|P|   Levothyroxine passes into breast milk but is unlikely to harm||
2020|149|P|a nursing infant. Consult your doctor before breastfeeding.||
2020|150|B|||
2020|151|I|DRUG INTERACTIONS:  See also How to Use section.||
2020|152|I|   Drug interactions may change how your medications work or||
2020|153|I|increase your risk for serious side effects. This document does||
2020|154|I|not contain all possible drug interactions. Keep a list of all||
2020|155|I|the products you use (including prescription/nonprescription||
2020|156|I|drugs and herbal products) and share it with your doctor and||
2020|157|I|pharmacist. Do not start, stop, or change the dosage of any||
2020|158|I|medicines without your doctor's approval.||
2020|159|B|||
2020|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2020|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2020|162|O|poison control center right away. US residents can call||
2020|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2020|164|O|Symptoms of overdose may include: fast/pounding/irregular||
2020|165|O|heartbeat, loss of consciousness, confusion, seizures.||
2020|166|B|||
2020|167|N|NOTES:  Do not share this medication with others.||
2020|168|N|   Lab and/or medical tests (such as thyroid function) should be||
2020|169|N|done while you are taking this medication. Keep all medical and||
2020|170|N|lab appointments.||
2020|171|B|||
2020|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2020|173|D|remember. If it is near the time of the next dose, skip the||
2020|174|D|missed dose. Take your next dose at the regular time. Do not||
2020|175|D|double the dose to catch up unless your doctor tells you to do||
2020|176|D|so. Call your doctor if you miss 2 or more doses in a row. Ask||
2020|177|D|your doctor ahead of time what to do about a missed dose and||
2020|178|D|follow your doctor's specific directions.||
2020|179|B|||
2020|180|R|STORAGE:  Store at room temperature away from light. This||
2020|181|R|medication comes in a bottle or in ampules. If the medication||
2020|182|R|comes in a bottle, store the medication in the original bottle.||
2020|183|R|Once the bottle is opened, use the medication within the time||
2020|184|R|directed by the manufacturer. Keep ampules in the pouch until||
2020|185|R|ready to use. Once the pouch is open, the ampules should be used||
2020|186|R|within 15 days. Keep all medications away from children and pets.||
2020|187|R|   Do not flush medications down the toilet or pour them into a||
2020|188|R|drain unless instructed to do so. Properly discard this product||
2020|189|R|when it is expired or no longer needed. Consult your pharmacist||
2020|190|R|or local waste disposal company.||
2020|191|B|||
2020|192|A|Information last revised July 2024.||
2020|193|A|Copyright(c) 2025 First Databank, Inc.||
2020|194|B|||
2021|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2021|002|Z|does NOT have all possible information about this product. This||
2021|003|Z|information does not assure that this product is safe, effective,||
2021|004|Z|or appropriate for you. This information is not individual||
2021|005|Z|medical advice and does not substitute for the advice of your||
2021|006|Z|health care professional. Always ask your health care||
2021|007|Z|professional for complete information about this product and your||
2021|008|Z|specific health needs.||
2021|009|B|||
2021|010|T|FLUNISOLIDE - NASAL||
2021|011|F|(flew-NISS-oh-lide)||
2021|012|B|||
2021|013|C|COMMON BRAND NAME(S): Nasalide, Nasarel||
2021|014|B|||
2021|015|U|USES:  Flunisolide is used to prevent and treat seasonal and||
2021|016|U|year-round allergy symptoms (such as stuffy/runny nose, itchy||
2021|017|U|eyes/nose/throat, sneezing). Flunisolide belongs to a class of||
2021|018|U|drugs known as corticosteroids. It works by reducing swelling||
2021|019|U|(inflammation) in the nasal passages.||
2021|020|B|||
2021|021|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
2021|022|H|your pharmacist before you start using this medication and each||
2021|023|H|time you get a refill. Follow the illustrated directions for the||
2021|024|H|proper use of this medication. If you have any questions, ask||
2021|025|H|your doctor or pharmacist.||
2021|026|H|   Use this medication as directed by your doctor , usually 1 or||
2021|027|H|2 sprays in each nostril 2 to 3 times a day. Avoid spraying this||
2021|028|H|medication in your eyes. Gently blow your nose before using this||
2021|029|H|drug. Gently shake the container before each use. Follow the||
2021|030|H|instructions to properly prime the spray pump if you are using it||
2021|031|H|for the first time, or if you have not used it for 5 or more||
2021|032|H|days, or if you have taken the pump apart to clean. Follow the||
2021|033|H|instructions to clean the spray pump if needed.||
2021|034|H|   To use the spray, first remove the safety clip and plastic||
2021|035|H|cap. Close one nostril by pressing it with your finger. Tilt your||
2021|036|H|head slightly forward and, keeping the bottle upright, carefully||
2021|037|H|insert the nasal applicator into the other nostril. Press down||
2021|038|H|firmly on the pump to deliver the prescribed number of sprays||
2021|039|H|while gently breathing in through the nose, keeping your mouth||
2021|040|H|closed. Do not spray directly onto the middle wall of your nose||
2021|041|H|(nasal septum). After spraying, remove the applicator tip and||
2021|042|H|tilt your head back for a few seconds. This will allow the||
2021|043|H|medication to spread over the back of your nose. Repeat in the||
2021|044|H|other nostril. Wipe the applicator tip and replace the plastic||
2021|045|H|cap. Avoid blowing your nose for 15 minutes after using this||
2021|046|H|medication.||
2021|047|H|   The dosage is based on your medical condition and response to||
2021|048|H|treatment. Younger children may need a smaller dose and help from||
2021|049|H|an adult to use this medication properly. Use this medication||
2021|050|H|regularly in order to get the most benefit from it. To help you||
2021|051|H|remember, use it at the same times each day. Do not increase your||
2021|052|H|dose or use it more often than directed.||
2021|053|H|   This medication does not work right away. Some people will||
2021|054|H|feel this medication working within 1 to 2 days, but it may take||
2021|055|H|up to 2 weeks before the full benefit of this drug takes effect.||
2021|056|H|Ask your doctor or pharmacist if you should also use other||
2021|057|H|medications (such as nose drops/spray, allergy drugs taken by||
2021|058|H|mouth) along with this drug until it takes full effect.||
2021|059|H|   Keep track of the number of sprays used from the bottle.||
2021|060|H|Discard the bottle after you have used the number of sprays||
2021|061|H|specified on the manufacturer's package. Do not pour any||
2021|062|H|remaining medication into another container. Follow the package||
2021|063|H|instructions to unblock the spray tip if needed and to clean the||
2021|064|H|spray bottle.||
2021|065|H|   Tell your doctor if your condition does not get better after 3||
2021|066|H|weeks or if it gets worse.||
2021|067|B|||
2021|068|S|SIDE EFFECTS:  Temporary nose/throat dryness or irritation,||
2021|069|S|cough, nosebleeds, sneezing and unpleasant taste/smell may occur.||
2021|070|S|If any of these side effects last or get worse, tell your doctor||
2021|071|S|or pharmacist promptly.||
2021|072|S|   Remember that this medication has been prescribed because your||
2021|073|S|doctor has judged that the benefit to you is greater than the||
2021|074|S|risk of side effects. Many people using this medication do not||
2021|075|S|have serious side effects.||
2021|076|S|   Tell your doctor right away if you have any serious side||
2021|077|S|effects, including: loss of taste or smell, pain/sores in your||
2021|078|S|nose.||
2021|079|S|   Rarely, it is possible that corticosteroids given in the nose||
2021|080|S|will be absorbed into the bloodstream. This can lead to side||
2021|081|S|effects of too much corticosteroid. These side effects are more||
2021|082|S|likely in children and people who use this medication for a long||
2021|083|S|time and in high doses. Tell your doctor right away if any of the||
2021|084|S|following side effects occur: unusual/extreme tiredness, weight||
2021|085|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
2021|086|S|vision problems.||
2021|087|S|   Corticosteroids may weaken the body's ability to fight||
2021|088|S|infections. This may make you more likely to get a serious||
2021|089|S|(rarely fatal) infection or make any infection you have worse.||
2021|090|S|This effect might also rarely occur with corticosteroids inhaled||
2021|091|S|through the nose (such as flunisolide). The risk may be increased||
2021|092|S|if high doses are used, especially when used for a long time.||
2021|093|S|Tell your doctor right away if you have any signs of infection||
2021|094|S|(such as sore throat that doesn't go away, ear pain, fever,||
2021|095|S|chills, white patches inside the nose or on the back of the||
2021|096|S|throat).||
2021|097|S|   A very serious allergic reaction to this drug is rare.||
2021|098|S|However, get medical help right away if you notice any symptoms||
2021|099|S|of a serious allergic reaction, including: rash, itching/swelling||
2021|100|S|(especially of the face/tongue/throat), severe dizziness,||
2021|101|S|wheezing/trouble breathing.||
2021|102|S|   This is not a complete list of possible side effects. If you||
2021|103|S|notice other effects not listed above, contact your doctor or||
2021|104|S|pharmacist.||
2021|105|S|   In the US -||
2021|106|S|   Call your doctor for medical advice about side effects. You||
2021|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2021|108|S|www.fda.gov/medwatch.||
2021|109|S|   In Canada - Call your doctor for medical advice about side||
2021|110|S|effects. You may report side effects to Health Canada at||
2021|111|S|1-866-234-2345.||
2021|112|B|||
2021|113|P|PRECAUTIONS:  Before using nasal flunisolide, tell your doctor or||
2021|114|P|pharmacist if you are allergic to it; or if you have any other||
2021|115|P|allergies. This product may contain inactive ingredients, which||
2021|116|P|can cause allergic reactions or other problems. Talk to your||
2021|117|P|pharmacist for more details.||
2021|118|P|   Before using this medication, tell your doctor or pharmacist||
2021|119|P|your medical history, especially of: eye problems (such as||
2021|120|P|glaucoma, cataracts), infections (including tuberculosis), recent||
2021|121|P|nose problems (such as injury, ulcers, surgery).||
2021|122|P|   Stay away from anyone who has an infection that may easily||
2021|123|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2021|124|P|doctor if you have been exposed to an infection or for more||
2021|125|P|details.||
2021|126|P|   Rarely, using corticosteroid medications for a long time can||
2021|127|P|make it more difficult for your body to respond to physical||
2021|128|P|stress. Before having surgery or emergency treatment, or if you||
2021|129|P|get a serious illness/injury, tell your doctor or dentist that||
2021|130|P|you are using this medication or have used this medication within||
2021|131|P|the past few months.||
2021|132|P|   Before having surgery, tell your doctor or dentist about all||
2021|133|P|the products you use (including prescription drugs,||
2021|134|P|nonprescription drugs, and herbal products).||
2021|135|P|   Though it is unlikely, this medication may temporarily slow||
2021|136|P|down a child's growth if used for a long time. See the doctor||
2021|137|P|regularly so your child's height can be checked.||
2021|138|P|   During pregnancy, this medication should be used only when||
2021|139|P|clearly needed. Rarely, infants born to mothers who have been||
2021|140|P|using corticosteroids (including flunisolide) for a long time may||
2021|141|P|have low levels of corticosteroid hormone. Tell your doctor right||
2021|142|P|away if you notice symptoms such as nausea/vomiting that doesn't||
2021|143|P|stop, severe diarrhea, or weakness in your newborn. Discuss the||
2021|144|P|risks and benefits with your doctor.||
2021|145|P|   It is unknown if nasal flunisolide passes into breast milk.||
2021|146|P|However, similar drugs pass into breast milk. Consult your doctor||
2021|147|P|before breastfeeding.||
2021|148|B|||
2021|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2021|150|I|medications work or increase your risk for serious side effects.||
2021|151|I|This document does not contain all possible drug interactions.||
2021|152|I|Keep a list of all the products you use (including||
2021|153|I|prescription/nonprescription drugs and herbal products) and share||
2021|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
2021|155|I|the dosage of any medicines without your doctor's approval.||
2021|156|I|   Check all prescription medicine labels carefully since similar||
2021|157|I|medications (other corticosteroids such as prednisone) may||
2021|158|I|increase your risk of side effects if taken together with this||
2021|159|I|drug. Ask your doctor or pharmacist if you have any questions||
2021|160|I|about your medications.||
2021|161|B|||
2021|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2021|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2021|164|O|poison control center right away. US residents can call||
2021|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2021|166|B|||
2021|167|N|NOTES:  Do not share this medication with others.||
2021|168|N|   If you use this medication for a long time, lab and/or medical||
2021|169|N|tests (such as nose exams, height measurement in children) may be||
2021|170|N|done while you are using this medication. Keep all medical and||
2021|171|N|lab appointments. Consult your doctor for more details.||
2021|172|N|   Avoid substances (such as pollen, pet dander, dust mites,||
2021|173|N|mold, and smoke) that can worsen allergy symptoms.||
2021|174|B|||
2021|175|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2021|176|D|If it is near the time of the next dose, skip the missed dose.||
2021|177|D|Use your next dose at the regular time. Do not double the dose to||
2021|178|D|catch up.||
2021|179|B|||
2021|180|R|STORAGE:  Store at room temperature with the protective cap in||
2021|181|R|place. Keep container upright. Keep all medications away from||
2021|182|R|children and pets.||
2021|183|R|   Do not flush medications down the toilet or pour them into a||
2021|184|R|drain unless instructed to do so. Properly discard this product||
2021|185|R|when it is expired or no longer needed. Consult your pharmacist||
2021|186|R|or local waste disposal company.||
2021|187|B|||
2021|188|A|Information last revised November 2024.||
2021|189|A|Copyright(c) 2025 First Databank, Inc.||
2021|190|B|||
2022|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2022|002|Z|does NOT have all possible information about this product. This||
2022|003|Z|information does not assure that this product is safe, effective,||
2022|004|Z|or appropriate for you. This information is not individual||
2022|005|Z|medical advice and does not substitute for the advice of your||
2022|006|Z|health care professional. Always ask your health care||
2022|007|Z|professional for complete information about this product and your||
2022|008|Z|specific health needs.||
2022|009|B|||
2022|010|T|HEPARIN LOCK FLUSH-INJECTION||
2022|011|F|(HEP-a-rin)||
2022|012|B|||
2022|013|C|COMMON BRAND NAME(S): Hep-Lock||
2022|014|B|||
2022|015|U|USES:  This medication is used to keep IV catheters open and||
2022|016|U|flowing freely. Heparin helps to keep blood flowing smoothly and||
2022|017|U|from clotting in the catheter by making a certain natural||
2022|018|U|substance in your body (anti-clotting protein) work better. It is||
2022|019|U|known as an anticoagulant.||
2022|020|U|   This form of heparin must not be used to treat or prevent||
2022|021|U|blood clots in the body.||
2022|022|U|   Some products should not be used for newborns due to an||
2022|023|U|increased risk of side effects. Check with your doctor or||
2022|024|U|pharmacist for more details.||
2022|025|B|||
2022|026|H|HOW TO USE:  This medication is given by injection into the IV||
2022|027|H|catheter as directed by your doctor. Do not inject this||
2022|028|H|medication into the body.||
2022|029|H|   Heparin comes in many strengths. Serious (sometimes fatal)||
2022|030|H|injuries have occurred when the wrong strength was used. Check||
2022|031|H|that you are using the correct strength and dose before injecting||
2022|032|H|this medication.||
2022|033|H|   Flush the catheter/line with normal saline before and after||
2022|034|H|infusing drugs that interact with heparin such as doxorubicin,||
2022|035|H|droperidol, ciprofloxacin, and mitoxantrone.||
2022|036|H|   If you are using this medication at home, learn all||
2022|037|H|preparation and usage instructions from your health care||
2022|038|H|professional. Before using, check this product for particles or||
2022|039|H|discoloration. If either is present, do not use the liquid. Learn||
2022|040|H|how to store and discard medical supplies safely.||
2022|041|B|||
2022|042|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
2022|043|S|because your doctor has judged that the benefit to you is greater||
2022|044|S|than the risk of side effects. Many people using this medication||
2022|045|S|do not have serious side effects.||
2022|046|S|   Although very unlikely, this medication can cause bleeding if||
2022|047|S|its effect on your clotting proteins is too much. Tell your||
2022|048|S|doctor right away if you develop any signs of serious bleeding,||
2022|049|S|including unusual pain/swelling/discomfort, prolonged bleeding||
2022|050|S|from cuts or gums, frequent nosebleeds, unusually heavy/prolonged||
2022|051|S|menstrual periods, unusual/easy bruising, dark urine, black||
2022|052|S|stools, severe headache, unusual dizziness.||
2022|053|S|   This drug may rarely cause certain serious (rarely fatal)||
2022|054|S|clotting problems (heparin-induced thrombocytopenia-HIT or||
2022|055|S|heparin-induced thrombocytopenia and thrombosis-HITT). This can||
2022|056|S|occur during treatment and up to several weeks after treatment||
2022|057|S|with heparin has stopped. You should not use heparin again if you||
2022|058|S|have HIT or HITT. If you notice any of the following very serious||
2022|059|S|side effects, get medical help right away: pain/loss of feeling||
2022|060|S|in the arms/legs, change in color of the arms/legs, chest pain,||
2022|061|S|trouble breathing, confusion, weakness on one side of the body,||
2022|062|S|trouble speaking, vision changes.||
2022|063|S|   A very serious allergic reaction to this drug is rare.||
2022|064|S|However, get medical help right away if you notice any symptoms||
2022|065|S|of a serious allergic reaction, including: fever, chills, rash,||
2022|066|S|itching/swelling (especially of the face/tongue/throat), severe||
2022|067|S|dizziness, trouble breathing.||
2022|068|S|   This is not a complete list of possible side effects. If you||
2022|069|S|notice other effects not listed above, contact your doctor or||
2022|070|S|pharmacist.||
2022|071|S|   In the US -||
2022|072|S|   Call your doctor for medical advice about side effects. You||
2022|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2022|074|S|www.fda.gov/medwatch.||
2022|075|S|   In Canada - Call your doctor for medical advice about side||
2022|076|S|effects. You may report side effects to Health Canada at||
2022|077|S|1-866-234-2345.||
2022|078|B|||
2022|079|P|PRECAUTIONS:  Before using heparin, tell your doctor or||
2022|080|P|pharmacist if you are allergic to it; or to pork products; or to||
2022|081|P|pentosan polysulfate sodium; or if you have any other allergies.||
2022|082|P|This product may contain inactive ingredients (such as benzyl||
2022|083|P|alcohol found in some brands), which can cause allergic reactions||
2022|084|P|or other problems. Talk to your pharmacist for more details.||
2022|085|P|   Before using this medication, tell your doctor or pharmacist||
2022|086|P|your medical history.||
2022|087|P|   Before having surgery, tell your doctor or dentist about all||
2022|088|P|the products you use (including prescription drugs,||
2022|089|P|nonprescription drugs, and herbal products).||
2022|090|P|   Tell your doctor if you are pregnant before using this||
2022|091|P|medication.||
2022|092|P|   This medication does not pass into breast milk. Consult your||
2022|093|P|doctor before breastfeeding.||
2022|094|B|||
2022|095|I|DRUG INTERACTIONS:  See also How to Use section.||
2022|096|I|   Drug interactions may change how your medications work or||
2022|097|I|increase your risk for serious side effects. This document does||
2022|098|I|not contain all possible drug interactions. Keep a list of all||
2022|099|I|the products you use (including prescription/nonprescription||
2022|100|I|drugs and herbal products) and share it with your doctor and||
2022|101|I|pharmacist. Do not start, stop, or change the dosage of any||
2022|102|I|medicines without your doctor's approval.||
2022|103|I|   This medication may interfere with certain lab tests (such as||
2022|104|I|prothrombin time), possibly causing false test results. Make sure||
2022|105|I|lab personnel and all your doctors know you use this drug.||
2022|106|B|||
2022|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2022|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2022|109|O|poison control center right away. US residents can call||
2022|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2022|111|O|Symptoms of overdose may include: easy/unusual bruising,||
2022|112|O|easy/unusual bleeding (such as frequent nosebleeds), blood in||
2022|113|O|urine, black stools.||
2022|114|B|||
2022|115|N|NOTES:  Not applicable.||
2022|116|B|||
2022|117|D|MISSED DOSE:  Not applicable.||
2022|118|B|||
2022|119|R|STORAGE:  Consult the product instructions and your pharmacist||
2022|120|R|for storage details. Keep all medications away from children and||
2022|121|R|pets.||
2022|122|R|   Do not flush medications down the toilet or pour them into a||
2022|123|R|drain unless instructed to do so. Properly discard this product||
2022|124|R|when it is expired or no longer needed. Consult your pharmacist||
2022|125|R|or local waste disposal company.||
2022|126|B|||
2022|127|A|Information last revised December 2024.||
2022|128|A|Copyright(c) 2025 First Databank, Inc.||
2022|129|B|||
2023|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2023|002|Z|does NOT have all possible information about this product. This||
2023|003|Z|information does not assure that this product is safe, effective,||
2023|004|Z|or appropriate for you. This information is not individual||
2023|005|Z|medical advice and does not substitute for the advice of your||
2023|006|Z|health care professional. Always ask your health care||
2023|007|Z|professional for complete information about this product and your||
2023|008|Z|specific health needs.||
2023|009|B|||
2023|010|T|VITAMIN D/FOLIC ACID - ORAL||
2023|011|F|(VYE-ta-min/FOE-lik AS-id)||
2023|012|B|||
2023|013|C|COMMON BRAND NAME(S): Folixapure, Noxifol-D, Ortho DF||
2023|014|B|||
2023|015|U|USES:  This medication contains 2 ingredients: vitamin D and||
2023|016|U|folic acid.||
2023|017|U|   Vitamin D is a fat-soluble vitamin that helps your body absorb||
2023|018|U|calcium and phosphorus. Having the right amount of vitamin D,||
2023|019|U|calcium, and phosphorus is important for building and keeping||
2023|020|U|strong bones. Vitamin D is made by the body when skin is exposed||
2023|021|U|to sunlight. Sunscreen, protective clothing, limited exposure to||
2023|022|U|sunlight, dark skin, and age may prevent getting enough vitamin D||
2023|023|U|from the sun.||
2023|024|U|   Folic acid is the man-made form of folate and may come in||
2023|025|U|different forms (such as L-methylfolate, levomefolate,||
2023|026|U|methyltetrahydrofolate). Folate is a B vitamin naturally found in||
2023|027|U|some foods. It is needed to form healthy cells, especially red||
2023|028|U|blood cells. Low folate levels can lead to certain types of||
2023|029|U|anemia. Conditions that can cause low folate levels include poor||
2023|030|U|diet, pregnancy, alcoholism, liver disease, certain||
2023|031|U|stomach/intestinal problems, kidney dialysis, among others. Women||
2023|032|U|of childbearing age should get enough folic acid through their||
2023|033|U|diet or supplements to prevent infant spinal cord birth defects.||
2023|034|B|||
2023|035|H|HOW TO USE:  Take vitamin D/folic acid by mouth with or without||
2023|036|H|food as directed by your doctor, usually once daily. The dosage||
2023|037|H|is based on your medical condition and response to treatment.||
2023|038|H|   Certain medications (bile acid sequestrants such as||
2023|039|H|cholestyramine/colestipol, mineral oil, orlistat) can decrease||
2023|040|H|the absorption of vitamin D. Take your doses of these medications||
2023|041|H|as far as possible from your doses of vitamin D/folic acid (at||
2023|042|H|least 2 hours apart, longer if possible).||
2023|043|H|   Take this medication regularly to get the most benefit from||
2023|044|H|it. To help you remember, take it at the same time each day.||
2023|045|H|   Tell your doctor if your condition lasts or gets worse.||
2023|046|B|||
2023|047|S|SIDE EFFECTS:  This medication usually has very few side effects.||
2023|048|S|If you have any unusual effects, tell your doctor or pharmacist||
2023|049|S|promptly.||
2023|050|S|   Remember that this medication has been prescribed because your||
2023|051|S|doctor has judged that the benefit to you is greater than the||
2023|052|S|risk of side effects. Many people using this medication do not||
2023|053|S|have serious side effects.||
2023|054|S|   Too much vitamin D can cause harmful high calcium levels. Tell||
2023|055|S|your doctor right away if any of these signs of high vitamin||
2023|056|S|D/calcium levels occur: nausea/vomiting, constipation, loss of||
2023|057|S|appetite, increased thirst, increased urination, mental/mood||
2023|058|S|changes, unusual tiredness.||
2023|059|S|   A very serious allergic reaction to this drug is rare.||
2023|060|S|However, get medical help right away if you notice any symptoms||
2023|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2023|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2023|063|S|breathing.||
2023|064|S|   This is not a complete list of possible side effects. If you||
2023|065|S|notice other effects not listed above, contact your doctor or||
2023|066|S|pharmacist.||
2023|067|S|   In the US -||
2023|068|S|   Call your doctor for medical advice about side effects. You||
2023|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2023|070|S|www.fda.gov/medwatch.||
2023|071|S|   In Canada - Call your doctor for medical advice about side||
2023|072|S|effects. You may report side effects to Health Canada at||
2023|073|S|1-866-234-2345.||
2023|074|B|||
2023|075|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2023|076|P|pharmacist if you are allergic to vitamin D or folic acid; or to||
2023|077|P|other vitamin D products (such as calcitriol); or if you have any||
2023|078|P|other allergies. This product may contain inactive ingredients,||
2023|079|P|which can cause allergic reactions or other problems. Talk to||
2023|080|P|your pharmacist for more details.||
2023|081|P|   Before using this medication, tell your doctor or pharmacist||
2023|082|P|your medical history, especially of: high calcium/vitamin D||
2023|083|P|levels (hypercalcemia/hypervitaminosis D), difficulty absorbing||
2023|084|P|nutrition from food (malabsorption syndrome), kidney disease,||
2023|085|P|liver disease, vitamin B-12 deficiency (pernicious anemia),||
2023|086|P|thyroid disease.||
2023|087|P|   Before having surgery, tell your doctor or dentist about all||
2023|088|P|the products you use (including prescription drugs,||
2023|089|P|nonprescription drugs, and herbal products).||
2023|090|P|   During pregnancy, doses of vitamin D greater than the||
2023|091|P|recommended dietary allowance should be used only when clearly||
2023|092|P|needed. Folic acid is safe to take during pregnancy when used as||
2023|093|P|directed. Discuss the risks and benefits with your doctor.||
2023|094|P|   This medication passes into breast milk. Consult your doctor||
2023|095|P|before breastfeeding.||
2023|096|B|||
2023|097|I|DRUG INTERACTIONS:  See also How to Use section.||
2023|098|I|   Drug interactions may change how your medications work or||
2023|099|I|increase your risk for serious side effects. This document does||
2023|100|I|not contain all possible drug interactions. Keep a list of all||
2023|101|I|the products you use (including prescription/nonprescription||
2023|102|I|drugs and herbal products) and share it with your doctor and||
2023|103|I|pharmacist. Do not start, stop, or change the dosage of any||
2023|104|I|medicines without your doctor's approval.||
2023|105|I|   Some products that may interact with this drug are: phosphate||
2023|106|I|binders.||
2023|107|I|   Vitamin D is very similar to calcitriol. Do not use||
2023|108|I|medications containing calcitriol while taking vitamin D/folic||
2023|109|I|acid.||
2023|110|I|   This medication may interfere with certain lab tests (such as||
2023|111|I|cholesterol tests), possibly causing false test results. Make||
2023|112|I|sure lab personnel and all your doctors know you use this drug.||
2023|113|B|||
2023|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2023|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2023|116|O|poison control center right away. US residents can call||
2023|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2023|118|B|||
2023|119|N|NOTES:  Do not share this medication with others.||
2023|120|N|   Lab and/or medical tests (such as calcium/magnesium/phosphorus||
2023|121|N|levels, complete blood count, folate/vitamin B-12 levels) may be||
2023|122|N|done while you are taking this medication. Keep all medical and||
2023|123|N|lab appointments.||
2023|124|N|   Foods rich in vitamin D include: fortified dairy products,||
2023|125|N|eggs, sardines, cod liver oil, chicken livers, and fatty fish.||
2023|126|N|Folate is naturally found in leafy green vegetables, organ meats||
2023|127|N|(liver, kidney), citrus fruits, and other foods. Folic acid is||
2023|128|N|added to enriched grain products such as bread, pasta, and||
2023|129|N|cereal.||
2023|130|B|||
2023|131|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2023|132|D|remember. If it is near the time of the next dose, skip the||
2023|133|D|missed dose. Take your next dose at the regular time. Do not||
2023|134|D|double the dose to catch up.||
2023|135|B|||
2023|136|R|STORAGE:  Store at room temperature away from light and moisture.||
2023|137|R|Do not store in the bathroom. Keep all medications away from||
2023|138|R|children and pets.||
2023|139|R|   Do not flush medications down the toilet or pour them into a||
2023|140|R|drain unless instructed to do so. Properly discard this product||
2023|141|R|when it is expired or no longer needed. Consult your pharmacist||
2023|142|R|or local waste disposal company.||
2023|143|B|||
2023|144|A|Information last revised May 2024.||
2023|145|A|Copyright(c) 2025 First Databank, Inc.||
2023|146|B|||
2024|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2024|002|Z|does NOT have all possible information about this product. This||
2024|003|Z|information does not assure that this product is safe, effective,||
2024|004|Z|or appropriate for you. This information is not individual||
2024|005|Z|medical advice and does not substitute for the advice of your||
2024|006|Z|health care professional. Always ask your health care||
2024|007|Z|professional for complete information about this product and your||
2024|008|Z|specific health needs.||
2024|009|B|||
2024|010|T|CAPLACIZUMAB - INJECTION||
2024|011|F|(KAP-la-SIZ-ue-mab)||
2024|012|B|||
2024|013|C|COMMON BRAND NAME(S): Cablivi||
2024|014|B|||
2024|015|U|USES:  This medication is used to treat a certain blood disorder||
2024|016|U|(acquired thrombotic thrombocytopenic purpura-aTTP). It is used||
2024|017|U|in combination with certain other treatments for this disorder||
2024|018|U|(plasma exchange, immune suppressing medication). In aTTP, blood||
2024|019|U|clots form in small blood vessels throughout the body. These||
2024|020|U|clots can cause serious medical problems if they block vessels||
2024|021|U|and limit or stop blood flow to organs such as the brain,||
2024|022|U|kidneys, and heart. This disorder can also cause red blood cells||
2024|023|U|to break apart faster than the body can replace them, which||
2024|024|U|results in anemia. Caplacizumab works by causing your body to||
2024|025|U|make fewer/smaller blood clots.||
2024|026|B|||
2024|027|H|HOW TO USE:  Read the Instructions for Use if available from your||
2024|028|H|pharmacist before you start using caplacizumab and each time you||
2024|029|H|get a refill. If you have any questions, ask your doctor or||
2024|030|H|pharmacist.||
2024|031|H|   The first dose of this medication is given by injection into a||
2024|032|H|vein by a health care professional as directed by your doctor,||
2024|033|H|usually at least 15 minutes before a certain blood procedure||
2024|034|H|(plasma exchange). After the first plasma exchange procedure, you||
2024|035|H|should receive another dose given by injection under the skin.||
2024|036|H|   After the first day, this medication is given by injection||
2024|037|H|under the skin as directed by your doctor, usually once daily.||
2024|038|H|The injection is given in the abdomen (except for a 2-inch area||
2024|039|H|around your belly button). On the days that you are having a||
2024|040|H|plasma exchange procedure, give this medication after the||
2024|041|H|procedure. The length of treatment is based on your medical||
2024|042|H|condition and response to treatment.||
2024|043|H|   If you are using this medication at home, learn all||
2024|044|H|preparation and usage instructions from your health care||
2024|045|H|professional and the product package. If the carton was not||
2024|046|H|stored at room temperature, allow the vial and the syringe to||
2024|047|H|reach room temperature by holding them in your hands for 10||
2024|048|H|seconds. Do not warm up this medication any other way (for||
2024|049|H|example, do not heat it in the microwave or place it in hot||
2024|050|H|water). Before using, check this product for particles or||
2024|051|H|discoloration. If either is present, do not use the liquid.||
2024|052|H|Before injecting each dose, clean the skin you are going to||
2024|053|H|inject into (the injection site) with rubbing alcohol. Change the||
2024|054|H|injection site each time to lessen injury under the skin. To||
2024|055|H|lessen bruising, do not rub the injection site after a shot.||
2024|056|H|Learn how to store and discard medical supplies safely.||
2024|057|H|   Use this medication regularly to get the most benefit from it.||
2024|058|H|To help you remember, use it at the same time each day.||
2024|059|H|   Tell your doctor if your condition does not get better or if||
2024|060|H|it gets worse.||
2024|061|B|||
2024|062|S|SIDE EFFECTS:  Headache, muscle ache, or tiredness may occur. You||
2024|063|S|may bruise or bleed more easily. Nosebleed and bleeding gums may||
2024|064|S|occur. It may take longer than usual to stop bleeding. If any of||
2024|065|S|these effects last or get worse, tell your doctor or pharmacist||
2024|066|S|promptly.||
2024|067|S|   Remember that this medication has been prescribed because your||
2024|068|S|doctor has judged that the benefit to you is greater than the||
2024|069|S|risk of side effects. Many people using this medication do not||
2024|070|S|have serious side effects.||
2024|071|S|   Tell your doctor right away if you have any signs of serious||
2024|072|S|bleeding, including: unusual pain/swelling/discomfort, unusually||
2024|073|S|heavy/prolonged menstrual flow, red/dark urine,||
2024|074|S|bloody/black/tarry stools, severe headache, dizziness/fainting,||
2024|075|S|unusual weakness.||
2024|076|S|   A very serious allergic reaction to this drug is rare.||
2024|077|S|However, get medical help right away if you notice any symptoms||
2024|078|S|of a serious allergic reaction, including: rash, itching/swelling||
2024|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2024|080|S|breathing.||
2024|081|S|   This is not a complete list of possible side effects. If you||
2024|082|S|notice other effects not listed above, contact your doctor or||
2024|083|S|pharmacist.||
2024|084|S|   In the US -||
2024|085|S|   Call your doctor for medical advice about side effects. You||
2024|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2024|087|S|www.fda.gov/medwatch.||
2024|088|S|   In Canada - Call your doctor for medical advice about side||
2024|089|S|effects. You may report side effects to Health Canada at||
2024|090|S|1-866-234-2345.||
2024|091|B|||
2024|092|P|PRECAUTIONS:  Before using caplacizumab, tell your doctor or||
2024|093|P|pharmacist if you are allergic to it; or if you have any other||
2024|094|P|allergies. This product may contain inactive ingredients, which||
2024|095|P|can cause allergic reactions or other problems. Talk to your||
2024|096|P|pharmacist for more details.||
2024|097|P|   Before using this medication, tell your doctor or pharmacist||
2024|098|P|your medical history, especially of: other bleeding/blood||
2024|099|P|problems (such as hemophilia), liver problems.||
2024|100|P|   Before having surgery or a dental procedure, tell your doctor||
2024|101|P|or dentist about all the products you use (including prescription||
2024|102|P|drugs, nonprescription drugs, and herbal products). This||
2024|103|P|medication should be temporarily stopped for at least 7 days||
2024|104|P|before having scheduled surgery, dental procedure, or any||
2024|105|P|procedure with increased risk of bleeding.||
2024|106|P|   To lower the chance of getting cut, bruised, or injured, use||
2024|107|P|caution with sharp objects like razors and nail cutters, and||
2024|108|P|avoid activities such as contact sports.||
2024|109|P|   During pregnancy, this medication should be used only when||
2024|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
2024|111|P|   It is unknown if this medication passes into breast milk.||
2024|112|P|Consult your doctor before breastfeeding.||
2024|113|B|||
2024|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2024|115|I|medications work or increase your risk for serious side effects.||
2024|116|I|This document does not contain all possible drug interactions.||
2024|117|I|Keep a list of all the products you use (including||
2024|118|I|prescription/nonprescription drugs and herbal products) and share||
2024|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
2024|120|I|the dosage of any medicines without your doctor's approval.||
2024|121|I|   Some products that may interact with this drug are: other||
2024|122|I|drugs that can cause bleeding/bruising (including antiplatelet||
2024|123|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
2024|124|I|"blood thinners" such as warfarin/dabigatran).||
2024|125|I|   Aspirin can increase the risk of bleeding when used with this||
2024|126|I|medication. However, if your doctor has told you to take low-dose||
2024|127|I|aspirin to prevent heart attack or stroke (usually 81-162||
2024|128|I|milligrams a day), you should keep taking the aspirin unless your||
2024|129|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2024|130|I|details.||
2024|131|B|||
2024|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2024|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2024|134|O|poison control center right away. US residents can call||
2024|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2024|136|B|||
2024|137|N|NOTES:  Do not share this medication with others.||
2024|138|N|   Lab and/or medical tests (such as complete blood count, blood||
2024|139|N|clotting tests) should be done while you are using this||
2024|140|N|medication. Keep all medical and lab appointments.||
2024|141|B|||
2024|142|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2024|143|D|If it is more than 12 hours after the missed dose, skip the||
2024|144|D|missed dose. Use your next dose at the regular time. Do not||
2024|145|D|double the dose to catch up.||
2024|146|B|||
2024|147|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2024|148|R|medication in the original carton to protect from light. This||
2024|149|R|medication may also be stored at room temperature if needed. If||
2024|150|R|the medication is stored at room temperature, do not put it back||
2024|151|R|in the refrigerator and discard after 2 months. Keep all||
2024|152|R|medications away from children and pets.||
2024|153|R|   Do not flush medications down the toilet or pour them into a||
2024|154|R|drain unless instructed to do so. Properly discard this product||
2024|155|R|when it is expired or no longer needed. Consult your pharmacist||
2024|156|R|or local waste disposal company.||
2024|157|B|||
2024|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
2024|159|M|medical emergency. For information about enrolling in MedicAlert,||
2024|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2024|161|B|||
2024|162|A|Information last revised October 2024.||
2024|163|A|Copyright(c) 2025 First Databank, Inc.||
2024|164|B|||
2025|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2025|002|Z|does NOT have all possible information about this product. This||
2025|003|Z|information does not assure that this product is safe, effective,||
2025|004|Z|or appropriate for you. This information is not individual||
2025|005|Z|medical advice and does not substitute for the advice of your||
2025|006|Z|health care professional. Always ask your health care||
2025|007|Z|professional for complete information about this product and your||
2025|008|Z|specific health needs.||
2025|009|B|||
2025|010|T|LOPERAMIDE/SIMETHICONE - ORAL||
2025|011|F|(low-PAIR-uh-mide/sye-METH-ih-cone)||
2025|012|B|||
2025|013|C|COMMON BRAND NAME(S): Imodium Advanced||
2025|014|B|||
2025|015|W|WARNING:  Improper use of this product (overuse or abuse) may||
2025|016|W|cause serious harm, such as fast/irregular heartbeat or death. Do||
2025|017|W|not increase your dose, take it more often, or take it for longer||
2025|018|W|than directed. Taking loperamide with certain other medications||
2025|019|W|may also cause harm. See also Precautions, Drug Interactions, and||
2025|020|W|Overdose sections.||
2025|021|W|   This medication should not be used by children younger than 2||
2025|022|W|years due to an increased risk of side effects (such as||
2025|023|W|slow/shallow breathing, fast/irregular heartbeat).||
2025|024|B|||
2025|025|U|USES:  See also Warning section.||
2025|026|U|   This combination medication is used to treat diarrhea and||
2025|027|U|symptoms of gas (such as cramps, bloating, pressure). Loperamide||
2025|028|U|works by slowing down the movement of the gut. This decreases the||
2025|029|U|number of bowel movements and makes the stool less watery.||
2025|030|U|Simethicone helps break up gas bubbles in the gut.||
2025|031|U|   This product treats only the symptoms, not the cause of the||
2025|032|U|diarrhea (such as infection). Treatment of other symptoms and the||
2025|033|U|cause of the diarrhea should be determined by your doctor.||
2025|034|B|||
2025|035|H|HOW TO USE:  See also Warning section.||
2025|036|H|   If you are using the over-the-counter product to self-treat,||
2025|037|H|read all the directions on the product package before taking this||
2025|038|H|medication. If your doctor has prescribed this medication, follow||
2025|039|H|your doctor's directions and the directions on your prescription||
2025|040|H|label.||
2025|041|H|   Take this medication by mouth after each loose bowel movement||
2025|042|H|as needed, or as directed by your doctor. The dosage is based on||
2025|043|H|your condition and response to treatment. Children's dosage is||
2025|044|H|also based on age and weight. Follow the directions on the||
2025|045|H|package for further doses if needed after your first dose. Do not||
2025|046|H|take more of this medication than recommended for your age on the||
2025|047|H|package label.||
2025|048|H|   Diarrhea can cause dehydration. Drink plenty of fluids and||
2025|049|H|minerals (electrolytes) to replace what is lost. Tell your doctor||
2025|050|H|right away if you develop signs of dehydration (such as extreme||
2025|051|H|thirst, decreased urination, muscle cramps, weakness, fainting).||
2025|052|H|You may also need to change to a bland diet during this time to||
2025|053|H|reduce irritation to your stomach/intestines. Consult your doctor||
2025|054|H|or pharmacist for more information.||
2025|055|H|   Tell your doctor if your diarrhea does not get better after 2||
2025|056|H|days, if your condition gets worse, or if you develop new||
2025|057|H|symptoms. If you develop blood in the stool, fever, or an||
2025|058|H|uncomfortable fullness/swelling of the stomach/abdomen, or if you||
2025|059|H|think you may have a serious medical problem, get medical help||
2025|060|H|right away.||
2025|061|B|||
2025|062|S|SIDE EFFECTS:  Dizziness, drowsiness, tiredness, or constipation||
2025|063|S|may occur. If any of these effects last or get worse, contact||
2025|064|S|your doctor promptly.||
2025|065|S|   If your doctor has directed you to use this medication,||
2025|066|S|remember that your doctor has judged that the benefit to you is||
2025|067|S|greater than the risk of side effects. Many people using this||
2025|068|S|medication do not have serious side effects.||
2025|069|S|   Stop taking this medication and get medical help right away if||
2025|070|S|you have any very serious side effects, including: severe||
2025|071|S|constipation/nausea/vomiting, stomach/abdominal pain,||
2025|072|S|uncomfortable fullness of the stomach/abdomen, fast/irregular||
2025|073|S|heartbeat, severe dizziness, fainting.||
2025|074|S|   A very serious allergic reaction to this drug is rare.||
2025|075|S|However, get medical help right away if you notice any symptoms||
2025|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2025|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2025|078|S|breathing.||
2025|079|S|   This is not a complete list of possible side effects. If you||
2025|080|S|notice other effects not listed above, contact your doctor or||
2025|081|S|pharmacist.||
2025|082|S|   In the US -||
2025|083|S|   Call your doctor for medical advice about side effects. You||
2025|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2025|085|S|www.fda.gov/medwatch.||
2025|086|S|   In Canada - Call your doctor for medical advice about side||
2025|087|S|effects. You may report side effects to Health Canada at||
2025|088|S|1-866-234-2345.||
2025|089|B|||
2025|090|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2025|091|P|pharmacist if you are allergic to loperamide; or to simethicone;||
2025|092|P|or if you have any other allergies. This product may contain||
2025|093|P|inactive ingredients, which can cause allergic reactions or other||
2025|094|P|problems. Talk to your pharmacist for more details.||
2025|095|P|   If you have any of the following health problems, consult your||
2025|096|P|doctor or pharmacist before using this medication:||
2025|097|P|stomach/abdominal pain without diarrhea, bowel obstruction (such||
2025|098|P|as ileus, megacolon, abdominal distention), black/tarry stool,||
2025|099|P|blood/mucus in your stool, high fever, HIV infection/AIDS, liver||
2025|100|P|problems, certain stomach/intestinal infections (such as||
2025|101|P|Salmonella, Shigella), certain type of bowel disease (acute||
2025|102|P|ulcerative colitis).||
2025|103|P|   Antibiotics may rarely cause a severe intestinal condition due||
2025|104|P|to a bacteria called C. difficile. Symptoms include: diarrhea||
2025|105|P|that doesn't stop, abdominal or stomach pain/cramping, or||
2025|106|P|blood/mucus in your stool. This condition may occur during||
2025|107|P|treatment or weeks to months after treatment has stopped. This||
2025|108|P|medication may make this condition worse. Do not use this||
2025|109|P|anti-diarrhea product, especially after recent antibiotic use, if||
2025|110|P|you have the above symptoms without talking with your doctor||
2025|111|P|first.||
2025|112|P|   Loperamide may cause a condition that affects the heart rhythm||
2025|113|P|(QT prolongation). QT prolongation can rarely cause serious||
2025|114|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2025|115|P|as severe dizziness, fainting) that need medical attention right||
2025|116|P|away.||
2025|117|P|   The risk of QT prolongation may be increased if you have||
2025|118|P|certain medical conditions or are taking other drugs that may||
2025|119|P|cause QT prolongation. Before using loperamide, tell your doctor||
2025|120|P|or pharmacist of all the drugs you take and if you have any of||
2025|121|P|the following conditions: certain heart problems (heart failure,||
2025|122|P|slow heartbeat, QT prolongation in the EKG), family history of||
2025|123|P|certain heart problems (QT prolongation in the EKG, sudden||
2025|124|P|cardiac death).||
2025|125|P|   Low levels of potassium or magnesium in the blood may also||
2025|126|P|increase your risk of QT prolongation. This risk may increase if||
2025|127|P|you use certain drugs (such as diuretics/"water pills") or if you||
2025|128|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2025|129|P|Talk to your doctor about using loperamide safely.||
2025|130|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2025|131|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2025|132|P|machinery, or do anything that needs alertness until you can do||
2025|133|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2025|134|P|are using marijuana (cannabis).||
2025|135|P|   Older adults may be more sensitive to the side effects of this||
2025|136|P|drug, especially QT prolongation (see above).||
2025|137|P|   Children may be more sensitive to the side effects of this||
2025|138|P|drug, especially drowsiness. Children are also at a higher risk||
2025|139|P|for dehydration. See also Warning and How to Use sections.||
2025|140|P|   During pregnancy, this medication should be used only if||
2025|141|P|clearly needed. Discuss the risks and benefits with your doctor.||
2025|142|P|   This drug passes into breast milk but is unlikely to harm a||
2025|143|P|nursing infant. Consult your doctor before breastfeeding.||
2025|144|B|||
2025|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2025|146|I|medications work or increase your risk for serious side effects.||
2025|147|I|This document does not contain all possible drug interactions.||
2025|148|I|Keep a list of all the products you use (including||
2025|149|I|prescription/nonprescription drugs and herbal products) and share||
2025|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
2025|151|I|the dosage of any medicines without your doctor's approval.||
2025|152|I|   Some products that may interact with this drug include:||
2025|153|I|pramlintide, recent/current antibiotic use, cholestyramine,||
2025|154|I|ritonavir.||
2025|155|I|   Many drugs besides loperamide may affect the heart rhythm (QT||
2025|156|I|prolongation), including amiodarone, chlorpromazine, haloperidol,||
2025|157|I|methadone, moxifloxacin, pentamidine, procainamide, quinidine,||
2025|158|I|sotalol, thioridazine, ziprasidone, among others.||
2025|159|I|   Check the label of any prescription or nonprescription||
2025|160|I|medication you may use, including any antacids or digestive||
2025|161|I|medications since some combination products may also contain||
2025|162|I|simethicone.||
2025|163|I|   Simethicone can decrease the absorption of thyroid medications||
2025|164|I|(such as levothyroxine). If you take thyroid medication, take it||
2025|165|I|at least 4 hours before or after products that contain||
2025|166|I|simethicone.||
2025|167|B|||
2025|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2025|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2025|170|O|poison control center right away. US residents can call||
2025|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2025|172|O|Symptoms of overdose may include: difficult urination, slowed||
2025|173|O|breathing, deep sleep, fast/irregular heartbeat, severe||
2025|174|O|dizziness, fainting.||
2025|175|B|||
2025|176|N|NOTES:  If your doctor has prescribed this medication for you, do||
2025|177|N|not share it with others.||
2025|178|B|||
2025|179|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
2025|180|D|(not "as needed") and you miss a dose, take it as soon as you||
2025|181|D|remember. If it is near the time of the next dose, skip the||
2025|182|D|missed dose. Take your next dose at the regular time. Do not||
2025|183|D|double the dose to catch up.||
2025|184|B|||
2025|185|R|STORAGE:  Store at room temperature away from light and moisture.||
2025|186|R|Do not store in the bathroom. Keep all medications away from||
2025|187|R|children and pets.||
2025|188|R|   Do not flush medications down the toilet or pour them into a||
2025|189|R|drain unless instructed to do so. Properly discard this product||
2025|190|R|when it is expired or no longer needed. Consult your pharmacist||
2025|191|R|or local waste disposal company.||
2025|192|B|||
2025|193|A|Information last revised November 2024.||
2025|194|A|Copyright(c) 2025 First Databank, Inc.||
2025|195|B|||
2027|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2027|002|Z|does NOT have all possible information about this product. This||
2027|003|Z|information does not assure that this product is safe, effective,||
2027|004|Z|or appropriate for you. This information is not individual||
2027|005|Z|medical advice and does not substitute for the advice of your||
2027|006|Z|health care professional. Always ask your health care||
2027|007|Z|professional for complete information about this product and your||
2027|008|Z|specific health needs.||
2027|009|B|||
2027|010|T|ESTROGEN/PROGESTIN - ORAL||
2027|011|F|(ES-troe-jen/proe-JES-tin)||
2027|012|B|||
2027|013|W|WARNING:  Estrogens, either used alone or with a progestin, have||
2027|014|W|rarely caused very serious side effects. Discuss the risks and||
2027|015|W|benefits of hormone treatment with your doctor. Estrogens and||
2027|016|W|progestins should not be used to prevent heart disease or||
2027|017|W|dementia.||
2027|018|W|   In postmenopausal women, estrogen when used with a progestin||
2027|019|W|can increase the risk of heart disease (such as heart attacks),||
2027|020|W|stroke, serious blood clots in the lungs/legs, dementia, and||
2027|021|W|cancer of the breast/ovaries.||
2027|022|W|   The risk for serious side effects may depend on the dose of||
2027|023|W|estrogen and the length of time it is used. This medication||
2027|024|W|should be used at the lowest effective dose and for the shortest||
2027|025|W|amount of time. Discuss the use of this medication with your||
2027|026|W|doctor regularly (for example, every 3 to 6 months) to see if you||
2027|027|W|still need to use it. If you will be using this medication||
2027|028|W|long-term, you should have regular complete physical exams (for||
2027|029|W|example, once a year) as directed by your doctor. See also Notes||
2027|030|W|section.||
2027|031|B|||
2027|032|U|USES:  This medication contains 2 hormones: an estrogen (such as||
2027|033|U|conjugated estrogen, estradiol) and a progestin (such as||
2027|034|U|medroxyprogesterone, norethindrone, norgestimate). Some brands of||
2027|035|U|this medication may contain progesterone instead of a progestin.||
2027|036|U|Progesterone and progestin both act like the form of the natural||
2027|037|U|hormone (progesterone) produced by your body. This medication is||
2027|038|U|used by women to help reduce symptoms of menopause (such as hot||
2027|039|U|flashes, vaginal dryness). These symptoms are caused by the body||
2027|040|U|making less estrogen. The progestin or progesterone in this||
2027|041|U|medication helps to reduce the risk of cancer of the uterus which||
2027|042|U|can be caused by using estrogen. Women who have had their uterus||
2027|043|U|removed do not need the progestin or progesterone. They should||
2027|044|U|not use this combination medication.||
2027|045|U|   If you are using this medication to treat symptoms only in and||
2027|046|U|around the vagina, products applied directly inside the vagina||
2027|047|U|should be considered before medications that are taken by mouth,||
2027|048|U|absorbed through the skin, or injected.||
2027|049|U|   This medication may also be used by women after menopause to||
2027|050|U|prevent bone loss (osteoporosis). However, there are other||
2027|051|U|medications (such as raloxifene, bisphosphonates including||
2027|052|U|alendronate) that are also effective in preventing bone loss and||
2027|053|U|may be safer. These medications should be considered for use||
2027|054|U|before estrogen/progestin treatment.||
2027|055|B|||
2027|056|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2027|057|H|from your pharmacist before you start using this medication and||
2027|058|H|each time you get a refill. If you have any questions, ask your||
2027|059|H|doctor or pharmacist.||
2027|060|H|   Take this medication by mouth with or without food as directed||
2027|061|H|by your doctor, usually once daily. You may take it with food or||
2027|062|H|right after a meal to prevent stomach upset.||
2027|063|H|   The dosage is based on your medical condition and response to||
2027|064|H|treatment.||
2027|065|H|   Take this medication regularly to get the most benefit from||
2027|066|H|it. To help you remember, take it at the same time each day.||
2027|067|H|Follow your dosing schedule carefully. Do not increase your dose||
2027|068|H|or take this medication more often or for a longer time than||
2027|069|H|directed.||
2027|070|H|   Tell your doctor if your condition does not get better or if||
2027|071|H|it gets worse.||
2027|072|B|||
2027|073|S|SIDE EFFECTS:  See also Warning section.||
2027|074|S|   Stomach upset, nausea/vomiting, bloating, breast tenderness,||
2027|075|S|headache, or weight changes may occur. If any of these effects||
2027|076|S|last or get worse, tell your doctor or pharmacist promptly.||
2027|077|S|   Remember that this medication has been prescribed because your||
2027|078|S|doctor has judged that the benefit to you is greater than the||
2027|079|S|risk of side effects. Many people using this medication do not||
2027|080|S|have serious side effects.||
2027|081|S|   Tell your doctor right away if you have any serious side||
2027|082|S|effects, including: nausea/vomiting that doesn't stop,||
2027|083|S|mental/mood changes (such as depression, memory loss), breast||
2027|084|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
2027|085|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
2027|086|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
2027|087|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
2027|088|S|increased thirst/urination.||
2027|089|S|   This medication may rarely cause serious (sometimes fatal)||
2027|090|S|problems from blood clots (such as heart attack, stroke, blood||
2027|091|S|clots in the lungs or legs). Get medical help right away if you||
2027|092|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
2027|093|S|headaches, weakness on one side of the body, confusion, trouble||
2027|094|S|speaking, sudden vision changes, pain/swelling/warmth in the||
2027|095|S|groin/calf, shortness of breath/rapid breathing, sudden||
2027|096|S|dizziness/fainting.||
2027|097|S|   A very serious allergic reaction to this drug is rare.||
2027|098|S|However, get medical help right away if you notice any symptoms||
2027|099|S|of a serious allergic reaction, including: rash, itching/swelling||
2027|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2027|101|S|breathing.||
2027|102|S|   This is not a complete list of possible side effects. If you||
2027|103|S|notice other effects not listed above, contact your doctor or||
2027|104|S|pharmacist.||
2027|105|S|   In the US -||
2027|106|S|   Call your doctor for medical advice about side effects. You||
2027|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2027|108|S|www.fda.gov/medwatch.||
2027|109|S|   In Canada - Call your doctor for medical advice about side||
2027|110|S|effects. You may report side effects to Health Canada at||
2027|111|S|1-866-234-2345.||
2027|112|B|||
2027|113|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2027|114|P|pharmacist if you are allergic to it; or if you have any other||
2027|115|P|allergies. This product may contain inactive ingredients, which||
2027|116|P|can cause allergic reactions or other problems. Talk to your||
2027|117|P|pharmacist for more details.||
2027|118|P|   Before using this medication, tell your doctor or pharmacist||
2027|119|P|your medical history, especially of: vaginal bleeding of unknown||
2027|120|P|cause, certain cancers (such as breast cancer, cancer of the||
2027|121|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
2027|122|P|heart attack), liver disease, kidney disease, family medical||
2027|123|P|history (especially breast lumps, cancer, blood clots), family or||
2027|124|P|personal history of a certain swelling disorder (angioedema),||
2027|125|P|blood clotting disorders (such as protein C or protein S||
2027|126|P|deficiency), high blood pressure, diabetes, high blood||
2027|127|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
2027|128|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
2027|129|P|calcium in the blood), a certain hormone problem||
2027|130|P|(hypoparathyroidism), uterus problems (such as fibroids,||
2027|131|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
2027|132|P|headaches, a certain blood disorder (porphyria), mental/mood||
2027|133|P|disorders (such as dementia, depression).||
2027|134|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
2027|135|P|further increases your risk of stroke, blood clots, high blood||
2027|136|P|pressure, and heart attack, especially in women older than 35.||
2027|137|P|   Tell your doctor if you just had or will be having surgery, or||
2027|138|P|if you will be confined to a chair or bed for a long time (such||
2027|139|P|as a long plane flight). These conditions increase your risk of||
2027|140|P|getting blood clots, especially if you are using an estrogen||
2027|141|P|product. You may need to stop this medication for a time or take||
2027|142|P|special precautions.||
2027|143|P|   This medication may cause blotchy, dark areas on your face and||
2027|144|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
2027|145|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
2027|146|P|wear protective clothing when outdoors.||
2027|147|P|   If you are nearsighted or wear contact lenses, you may develop||
2027|148|P|vision problems or trouble wearing your contact lenses. Contact||
2027|149|P|your eye doctor if these problems occur.||
2027|150|P|   This medication should not be used during pregnancy. If you||
2027|151|P|become pregnant or think you may be pregnant, tell your doctor||
2027|152|P|right away.||
2027|153|P|   This medication passes into breast milk. Consult your doctor||
2027|154|P|before breastfeeding.||
2027|155|B|||
2027|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2027|157|I|medications work or increase your risk for serious side effects.||
2027|158|I|This document does not contain all possible drug interactions.||
2027|159|I|Keep a list of all the products you use (including||
2027|160|I|prescription/nonprescription drugs and herbal products) and share||
2027|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
2027|162|I|the dosage of any medicines without your doctor's approval.||
2027|163|I|   Some products that may interact with this drug include:||
2027|164|I|aromatase inhibitors (such as anastrozole, exemestane,||
2027|165|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
2027|166|I|tamoxifen, toremifene, tranexamic acid.||
2027|167|I|   This medication may interfere with certain lab tests (such as||
2027|168|I|metyrapone test), possibly causing false test results. Make sure||
2027|169|I|lab personnel and all your doctors know you use this drug.||
2027|170|B|||
2027|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2027|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2027|173|O|poison control center right away. US residents can call||
2027|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2027|175|O|Symptoms of overdose may include: severe nausea/vomiting, unusual||
2027|176|O|vaginal bleeding.||
2027|177|B|||
2027|178|N|NOTES:  Do not share this medication with others.||
2027|179|N|   Regular complete physical exams which include lab and/or||
2027|180|N|medical tests (such as blood pressure, breast exam/mammogram,||
2027|181|N|pelvic exam, Pap smear) should be done while you are taking this||
2027|182|N|medication. Follow your doctor's instructions for examining your||
2027|183|N|breasts, and report any lumps right away. Keep all medical and||
2027|184|N|lab appointments. Consult your doctor for more details.||
2027|185|N|   Preventing or controlling high blood pressure, high||
2027|186|N|cholesterol, and diabetes can help to reduce your chances of||
2027|187|N|heart disease and stroke. Lifestyle changes that can help to||
2027|188|N|control or prevent these diseases include reducing stress, eating||
2027|189|N|a low fat/salt diet, losing weight if overweight, exercising||
2027|190|N|regularly, and stopping smoking. Keep your mind active with||
2027|191|N|mental exercises (such as reading, solving crossword puzzles) to||
2027|192|N|help prevent dementia. Talk to your doctor about lifestyle||
2027|193|N|changes that might benefit you.||
2027|194|N|   Lifestyle changes that may help reduce hot flashes include||
2027|195|N|stopping smoking, dressing lightly or in layers,||
2027|196|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
2027|197|N|reducing stress, and exercising regularly.||
2027|198|N|   Lifestyle changes that help promote healthy bones include||
2027|199|N|increasing weight-bearing exercise, stopping smoking, limiting||
2027|200|N|alcohol, and eating well-balanced meals that contain adequate||
2027|201|N|calcium and vitamin D. Since you may also need to take calcium||
2027|202|N|and vitamin D supplements and make lifestyle changes, consult||
2027|203|N|your doctor for specific advice.||
2027|204|B|||
2027|205|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2027|206|D|remember. If it is near the time of the next dose, skip the||
2027|207|D|missed dose. Take your next dose at the regular time. Do not||
2027|208|D|double the dose to catch up.||
2027|209|B|||
2027|210|R|STORAGE:  Store at room temperature away from light and moisture.||
2027|211|R|Do not store in the bathroom. Keep all medications away from||
2027|212|R|children and pets.||
2027|213|R|   Do not flush medications down the toilet or pour them into a||
2027|214|R|drain unless instructed to do so. Properly discard this product||
2027|215|R|when it is expired or no longer needed. Consult your pharmacist||
2027|216|R|or local waste disposal company.||
2027|217|B|||
2027|218|A|Information last revised March 2025.||
2027|219|A|Copyright(c) 2025 First Databank, Inc.||
2027|220|B|||
2028|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2028|002|Z|does NOT have all possible information about this product. This||
2028|003|Z|information does not assure that this product is safe, effective,||
2028|004|Z|or appropriate for you. This information is not individual||
2028|005|Z|medical advice and does not substitute for the advice of your||
2028|006|Z|health care professional. Always ask your health care||
2028|007|Z|professional for complete information about this product and your||
2028|008|Z|specific health needs.||
2028|009|B|||
2028|010|T|VANCOMYCIN (WITH PEG-400, NADA) - INJECTION||
2028|011|F|(VAN-koe-MYE-sin)||
2028|012|B|||
2028|013|W|WARNING:  Vancomycin injection solution with PEG-400 and NADA is||
2028|014|W|not recommended for use during the first or second trimester of||
2028|015|W|pregnancy. PEG-400 and NADA may harm an unborn baby. Tell your||
2028|016|W|doctor if you are pregnant, think you may be pregnant, or plan to||
2028|017|W|become pregnant. Your doctor can prescribe another vancomycin||
2028|018|W|product that can be used during pregnancy.||
2028|019|B|||
2028|020|U|USES:  Vancomycin is used to treat serious bacterial infections.||
2028|021|U|It is an antibiotic that works by stopping the growth of||
2028|022|U|bacteria.||
2028|023|B|||
2028|024|H|HOW TO USE:  This medication is usually given by injection into a||
2028|025|H|vein as directed by your doctor. Each dose should be injected||
2028|026|H|slowly over at least 1 hour. The dosage and length of treatment||
2028|027|H|are based on your medical condition, labs, weight, and response||
2028|028|H|to treatment.||
2028|029|H|   If you are using this medication at home, learn all||
2028|030|H|preparation and usage instructions from your health care||
2028|031|H|professional. Before using, check this product for particles or||
2028|032|H|discoloration. If either is present, do not use the liquid. Learn||
2028|033|H|how to store and discard medical supplies safely.||
2028|034|H|   Infusion reactions may happen during the infusion of this drug||
2028|035|H|if this drug is injected too fast. Tell your doctor right away if||
2028|036|H|you have any symptoms of infusion reactions such as flushing of||
2028|037|H|the upper body, dizziness, or muscle pain/spasms of the chest and||
2028|038|H|back. Your doctor may slow down or stop your treatment for some||
2028|039|H|time.||
2028|040|H|   For the best effect, use this antibiotic at evenly spaced||
2028|041|H|times. To help you remember, use this medication at the same||
2028|042|H|time(s) every day.||
2028|043|H|   Continue to use this medication until the full prescribed||
2028|044|H|amount is finished, even if symptoms disappear after a few days.||
2028|045|H|Stopping the medication too early may result in a return of the||
2028|046|H|infection.||
2028|047|H|   Tell your doctor if your condition lasts or gets worse.||
2028|048|B|||
2028|049|S|SIDE EFFECTS:  See also How to Use section.||
2028|050|S|   Pain, redness, and tenderness at the injection site may occur.||
2028|051|S|If any of these effects last or get worse, tell your doctor or||
2028|052|S|pharmacist promptly.||
2028|053|S|   Remember that this medication has been prescribed because your||
2028|054|S|doctor has judged that the benefit to you is greater than the||
2028|055|S|risk of side effects. Many people using this medication do not||
2028|056|S|have serious side effects.||
2028|057|S|   Tell your doctor right away if you have any serious side||
2028|058|S|effects, including: hearing problems (such as ringing in the||
2028|059|S|ears, hearing loss), signs of kidney problems (such as change in||
2028|060|S|the amount of urine), easy bleeding/bruising, vision changes||
2028|061|S|(such as blurred vision, decreased vision).||
2028|062|S|   This medication may rarely cause a severe intestinal condition||
2028|063|S|due to a bacteria called C. difficile. This condition may occur||
2028|064|S|during treatment or weeks to months after treatment has stopped.||
2028|065|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2028|066|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2028|067|S|stool.||
2028|068|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2028|069|S|products because they may make symptoms worse.||
2028|070|S|   Use of this medication for prolonged or repeated periods may||
2028|071|S|result in oral thrush or a new yeast infection. Contact your||
2028|072|S|doctor if you notice white patches in your mouth, a change in||
2028|073|S|vaginal discharge, or other new symptoms.||
2028|074|S|   A very serious allergic reaction to this drug is rare.||
2028|075|S|However, get medical help right away if you notice any symptoms||
2028|076|S|of a serious allergic reaction, including: fever that doesn't go||
2028|077|S|away, new or worsening lymph node swelling, rash,||
2028|078|S|itching/swelling (especially of the face/tongue/throat), severe||
2028|079|S|dizziness, trouble breathing.||
2028|080|S|   This is not a complete list of possible side effects. If you||
2028|081|S|notice other effects not listed above, contact your doctor or||
2028|082|S|pharmacist.||
2028|083|S|   In the US -||
2028|084|S|   Call your doctor for medical advice about side effects. You||
2028|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2028|086|S|www.fda.gov/medwatch.||
2028|087|S|   In Canada - Call your doctor for medical advice about side||
2028|088|S|effects. You may report side effects to Health Canada at||
2028|089|S|1-866-234-2345.||
2028|090|B|||
2028|091|P|PRECAUTIONS:  Before using vancomycin, tell your doctor or||
2028|092|P|pharmacist if you are allergic to it; or if you have any other||
2028|093|P|allergies. This product may contain inactive ingredients, which||
2028|094|P|can cause allergic reactions or other problems. Talk to your||
2028|095|P|pharmacist for more details.||
2028|096|P|   Before using this medication, tell your doctor or pharmacist||
2028|097|P|your medical history, especially of: kidney problems, hearing||
2028|098|P|problems, stomach/intestinal problems (such as colitis).||
2028|099|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2028|100|P|can make you more dizzy. Do not drive, use machinery, or do||
2028|101|P|anything that needs alertness until you can do it safely. Limit||
2028|102|P|alcoholic beverages. Talk to your doctor if you are using||
2028|103|P|marijuana (cannabis).||
2028|104|P|   Vancomycin may cause live bacterial vaccines (such as typhoid||
2028|105|P|vaccine) to not work well. Tell your health care professional||
2028|106|P|that you are using vancomycin before having any||
2028|107|P|immunizations/vaccinations.||
2028|108|P|   Before having surgery, tell your doctor or dentist about all||
2028|109|P|the products you use (including prescription drugs,||
2028|110|P|nonprescription drugs, and herbal products).||
2028|111|P|   Children may be at greater risk for infusion reactions,||
2028|112|P|especially when this medication is injected too fast.||
2028|113|P|   Older adults may be at greater risk for kidney and hearing||
2028|114|P|problems while using this drug.||
2028|115|P|   Tell your doctor if you are pregnant or plan to become||
2028|116|P|pregnant. You should not become pregnant while using this||
2028|117|P|product. Vancomycin solution with PEG-400 and NADA may harm an||
2028|118|P|unborn baby. If you become pregnant, talk to your doctor right||
2028|119|P|away about the risks and benefits of this medication. See also||
2028|120|P|Warning section.||
2028|121|P|   This medication passes into breast milk. Consult your doctor||
2028|122|P|before breastfeeding.||
2028|123|B|||
2028|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2028|125|I|medications work or increase your risk for serious side effects.||
2028|126|I|This document does not contain all possible drug interactions.||
2028|127|I|Keep a list of all the products you use (including||
2028|128|I|prescription/nonprescription drugs and herbal products) and share||
2028|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
2028|130|I|the dosage of any medicines without your doctor's approval.||
2028|131|I|   A product that may interact with this drug is: cidofovir.||
2028|132|B|||
2028|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2028|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2028|135|O|poison control center right away. US residents can call||
2028|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2028|137|B|||
2028|138|N|NOTES:  Lab and/or medical tests (such as kidney function,||
2028|139|N|vancomycin blood levels, blood cultures, complete blood counts,||
2028|140|N|hearing tests) should be done while you are using this||
2028|141|N|medication. Keep all medical and lab appointments.||
2028|142|B|||
2028|143|D|MISSED DOSE:  It is important to get each dose of this medication||
2028|144|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2028|145|D|right away for a new dosing schedule. Do not double the dose to||
2028|146|D|catch up.||
2028|147|B|||
2028|148|R|STORAGE:  Store this medication at room temperature in its outer||
2028|149|R|pouch until ready to use. If you remove the outer pouch, the||
2028|150|R|product should be used within 28 days. Keep all medications away||
2028|151|R|from children and pets.||
2028|152|R|   Do not flush medications down the toilet or pour them into a||
2028|153|R|drain unless instructed to do so. Properly discard this product||
2028|154|R|when it is expired or no longer needed. Consult your pharmacist||
2028|155|R|or local waste disposal company.||
2028|156|B|||
2028|157|A|Information last revised November 2024.||
2028|158|A|Copyright(c) 2025 First Databank, Inc.||
2028|159|B|||
2029|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2029|002|Z|does NOT have all possible information about this product. This||
2029|003|Z|information does not assure that this product is safe, effective,||
2029|004|Z|or appropriate for you. This information is not individual||
2029|005|Z|medical advice and does not substitute for the advice of your||
2029|006|Z|health care professional. Always ask your health care||
2029|007|Z|professional for complete information about this product and your||
2029|008|Z|specific health needs.||
2029|009|B|||
2029|010|T|ESKETAMINE NASAL - SPRAY||
2029|011|F|(es-KET-a-meen)||
2029|012|B|||
2029|013|C|COMMON BRAND NAME(S): Spravato||
2029|014|B|||
2029|015|W|WARNING:  Esketamine is given in a doctor's office or medical||
2029|016|W|clinic. This medication may cause drowsiness, dizziness,||
2029|017|W|fainting, anxiety, or serious (possibly fatal) slow/shallow||
2029|018|W|breathing. It may also cause you to feel disconnected from your||
2029|019|W|body, thoughts, feelings, space, and time (dissociation). You||
2029|020|W|must be monitored for at least 2 hours after each treatment by a||
2029|021|W|health care professional to make sure these side effects go away||
2029|022|W|and it is safe for you to leave the medical clinic or doctor's||
2029|023|W|office.||
2029|024|W|   This medication also has a risk for abuse and physical and||
2029|025|W|psychological dependence. See also How to Use section.||
2029|026|W|   To receive esketamine in the United States, you must||
2029|027|W|understand, agree to, and carefully follow the requirements of||
2029|028|W|the REMS Program for this medication. If you live in Canada or||
2029|029|W|any other country, consult your doctor and pharmacist for your||
2029|030|W|country's regulations.||
2029|031|W|   Antidepressant medications are used to treat a variety of||
2029|032|W|conditions, including depression and other mental/mood disorders.||
2029|033|W|These medications can help prevent suicidal thoughts/attempts and||
2029|034|W|provide other important benefits. However, studies have shown||
2029|035|W|that a small number of people (especially people younger than 25)||
2029|036|W|who take antidepressants for any condition may experience||
2029|037|W|worsening depression, other mental/mood symptoms, or suicidal||
2029|038|W|thoughts/attempts. It is very important to talk with the doctor||
2029|039|W|about the risks and benefits of antidepressant medication||
2029|040|W|(especially for people younger than 25), even if treatment is not||
2029|041|W|for a mental/mood condition.||
2029|042|W|   Tell the doctor right away if you notice worsening||
2029|043|W|depression/other psychiatric conditions, unusual behavior changes||
2029|044|W|(including possible suicidal thoughts/attempts), or other||
2029|045|W|mental/mood changes (including new/worsening anxiety, panic||
2029|046|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2029|047|W|impulsive actions, severe restlessness, very rapid speech). Be||
2029|048|W|especially watchful for these symptoms when a new antidepressant||
2029|049|W|is started or when the dose is changed.||
2029|050|B|||
2029|051|U|USES:  This medication is used alone or along with an||
2029|052|U|antidepressant taken by mouth to treat depression in adults.||
2029|053|U|Esketamine is thought to work by affecting the balance of a||
2029|054|U|certain natural substance (glutamate) in the brain.||
2029|055|B|||
2029|056|H|HOW TO USE:  See also Warning section.||
2029|057|H|   Read the Medication Guide provided by your pharmacist before||
2029|058|H|you start using esketamine and each time you go for treatment. If||
2029|059|H|you have any questions, ask your doctor or pharmacist.||
2029|060|H|   To reduce the risk of nausea and vomiting, avoid food for at||
2029|061|H|least 2 hours before treatment, and avoid drinking liquids for at||
2029|062|H|least 30 minutes before treatment.||
2029|063|H|   If you have a stuffy nose, ask your doctor if you should use a||
2029|064|H|corticosteroid spray or decongestant drops/spray in your nose at||
2029|065|H|least 1 hour before esketamine treatment.||
2029|066|H|   A health care professional will give you instructions for how||
2029|067|H|to use the nasal spray device. Blow your nose before you start||
2029|068|H|treatment. You may need to use more than one spray device based||
2029|069|H|on your dose. Spray once in each nostril per device. Lean your||
2029|070|H|head back and rest for 5 minutes after using each device. Do not||
2029|071|H|blow your nose right after a dose.||
2029|072|H|   You will be monitored during each treatment and afterward for||
2029|073|H|at least 2 hours. You will need to have someone drive you home||
2029|074|H|after each treatment.||
2029|075|H|   The dosage and treatment schedule are based on your medical||
2029|076|H|condition and response to treatment. Use this medication||
2029|077|H|regularly to get the most benefit from it. To help you remember,||
2029|078|H|mark your calendar with a reminder.||
2029|079|H|   If you suddenly stop using this medication, you may have||
2029|080|H|withdrawal symptoms (such as cravings, tiredness, poor appetite,||
2029|081|H|anxiety). To help prevent withdrawal, your doctor may lower your||
2029|082|H|dose slowly. Withdrawal is more likely if you have used||
2029|083|H|esketamine for a long time or in high doses. Tell your doctor or||
2029|084|H|pharmacist right away if you have withdrawal.||
2029|085|H|   When this medication is used for a long time, it may not work||
2029|086|H|as well. Talk with your doctor if this medication stops working||
2029|087|H|well.||
2029|088|H|   Tell your doctor if your condition does not get better or if||
2029|089|H|it gets worse.||
2029|090|B|||
2029|091|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2029|092|S|   Problems with thinking clearly, feeling drunk, a feeling of||
2029|093|S|spinning, or nausea, vomiting, dizziness, drowsiness, tiredness,||
2029|094|S|or reduced sense of touch may occur. If any of these effects last||
2029|095|S|or get worse, tell your doctor or pharmacist promptly.||
2029|096|S|   Remember that this medication has been prescribed because your||
2029|097|S|doctor has judged that the benefit to you is greater than the||
2029|098|S|risk of side effects. Many people using this medication do not||
2029|099|S|have serious side effects.||
2029|100|S|   Tell your doctor right away if you have any serious side||
2029|101|S|effects, including: increased urination at night, burning/pain||
2029|102|S|when you urinate, urgent or frequent urination.||
2029|103|S|   This medication may raise your blood pressure. An increase in||
2029|104|S|blood pressure can last about 4 hours after a dose of esketamine.||
2029|105|S|Your health care professional will check your blood pressure||
2029|106|S|before and after your dose. Get medical help right away if you||
2029|107|S|have any very serious side effects, including: chest pain,||
2029|108|S|shortness of breath, sudden severe headache, vision changes,||
2029|109|S|seizures, loss of consciousness.||
2029|110|S|   A very serious allergic reaction to this drug is rare.||
2029|111|S|However, get medical help right away if you notice any symptoms||
2029|112|S|of a serious allergic reaction, including: rash, itching/swelling||
2029|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2029|114|S|breathing.||
2029|115|S|   This is not a complete list of possible side effects. If you||
2029|116|S|notice other effects not listed above, contact your doctor or||
2029|117|S|pharmacist.||
2029|118|S|   In the US -||
2029|119|S|   Call your doctor for medical advice about side effects. You||
2029|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2029|121|S|www.fda.gov/medwatch.||
2029|122|S|   In Canada - Call your doctor for medical advice about side||
2029|123|S|effects. You may report side effects to Health Canada at||
2029|124|S|1-866-234-2345.||
2029|125|B|||
2029|126|P|PRECAUTIONS:  Before using esketamine, tell your doctor or||
2029|127|P|pharmacist if you are allergic to it; or to ketamine; or if you||
2029|128|P|have any other allergies. This product may contain inactive||
2029|129|P|ingredients, which can cause allergic reactions or other||
2029|130|P|problems. Talk to your pharmacist for more details.||
2029|131|P|   Before using this medication, tell your doctor or pharmacist||
2029|132|P|your medical history, especially of: blood vessel problems (such||
2029|133|P|as aneurysm in the brain/chest/aorta/abdomen/arms/legs,||
2029|134|P|arteriovenous malformation), bleeding/increased pressure in the||
2029|135|P|brain, high blood pressure (including a syndrome of high blood||
2029|136|P|pressure with seizures, severe headache, and coma), heart||
2029|137|P|disease, stroke, liver disease, a certain mental/mood disorder||
2029|138|P|(psychosis), personal or family history of a substance use||
2029|139|P|disorder (such as overuse of or addiction to drugs/alcohol).||
2029|140|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2029|141|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2029|142|P|machinery, or do anything that needs alertness until the next day||
2029|143|P|after a good night's sleep and until you can do it safely. Limit||
2029|144|P|alcoholic beverages. Talk to your doctor if you are using||
2029|145|P|marijuana (cannabis).||
2029|146|P|   Before having surgery, tell your doctor or dentist about all||
2029|147|P|the products you use (including prescription drugs,||
2029|148|P|nonprescription drugs, and herbal products).||
2029|149|P|   Tell your doctor if you are pregnant or plan to become||
2029|150|P|pregnant. You should not become pregnant while using esketamine.||
2029|151|P|Esketamine may harm an unborn baby. Ask about reliable forms of||
2029|152|P|birth control while using this medication. However, since||
2029|153|P|untreated mental/mood problems (such as depression) can harm a||
2029|154|P|pregnant woman and her unborn baby, do not stop using this||
2029|155|P|medication unless directed by your doctor. Ask your doctor if a||
2029|156|P|different medication would be right for you. If you become||
2029|157|P|pregnant or think you may be pregnant, talk to your doctor right||
2029|158|P|away about the risks and benefits of this medication.||
2029|159|P|   This medication passes into breast milk and may harm a nursing||
2029|160|P|infant. Breastfeeding is not recommended while using this||
2029|161|P|medication. Consult your doctor before breastfeeding.||
2029|162|B|||
2029|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2029|164|I|medications work or increase your risk for serious side effects.||
2029|165|I|This document does not contain all possible drug interactions.||
2029|166|I|Keep a list of all the products you use (including||
2029|167|I|prescription/nonprescription drugs and herbal products) and share||
2029|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
2029|169|I|the dosage of any medicines without your doctor's approval.||
2029|170|I|   Tell your doctor or pharmacist if you are using other products||
2029|171|I|that cause drowsiness such as opioid pain or cough relievers||
2029|172|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2029|173|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2029|174|I|zolpidem), muscle relaxants (such as carisoprodol,||
2029|175|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2029|176|I|diphenhydramine).||
2029|177|I|   Check the labels on all your medicines (such as allergy or||
2029|178|I|cough-and-cold products) because they may contain ingredients||
2029|179|I|that cause drowsiness. Ask your pharmacist about using those||
2029|180|I|products safely.||
2029|181|B|||
2029|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2029|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2029|184|O|poison control center right away. US residents can call||
2029|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2029|186|B|||
2029|187|N|NOTES:  Do not share this medication with others. Sharing it is||
2029|188|N|against the law.||
2029|189|N|   Keep all medical and lab appointments.||
2029|190|B|||
2029|191|D|MISSED DOSE:  It is important to get each dose of this medication||
2029|192|D|as scheduled. If you miss a dose, ask your doctor right away for||
2029|193|D|a new dosing schedule. Do not double the dose to catch up.||
2029|194|B|||
2029|195|R|STORAGE:  Not applicable. This medication is given in a medical||
2029|196|R|clinic or doctor's office and will not be stored at home.||
2029|197|B|||
2029|198|A|Information last revised February 2025.||
2029|199|A|Copyright(c) 2025 First Databank, Inc.||
2029|200|B|||
2030|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2030|002|Z|does NOT have all possible information about this product. This||
2030|003|Z|information does not assure that this product is safe, effective,||
2030|004|Z|or appropriate for you. This information is not individual||
2030|005|Z|medical advice and does not substitute for the advice of your||
2030|006|Z|health care professional. Always ask your health care||
2030|007|Z|professional for complete information about this product and your||
2030|008|Z|specific health needs.||
2030|009|B|||
2030|010|T|NETARSUDIL/LATANOPROST SOLUTION - OPHTHALMIC||
2030|011|F|(ne-TAR-soo-dill/la-TAN-oh-prost)||
2030|012|B|||
2030|013|C|COMMON BRAND NAME(S): Rocklatan||
2030|014|B|||
2030|015|U|USES:  Netarsudil/latanoprost is used to treat high pressure||
2030|016|U|inside the eye due to certain eye conditions (such as open-angle||
2030|017|U|glaucoma, ocular hypertension). Lowering high pressure inside the||
2030|018|U|eye can help prevent vision loss or blindness.||
2030|019|B|||
2030|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
2030|021|H|directed by your doctor, usually once a day in the evening. Do||
2030|022|H|not use this medication more often because it may increase your||
2030|023|H|risk for side effects and it may not work as well.||
2030|024|H|   To apply eye drops, wash hands first. To avoid contamination,||
2030|025|H|do not touch the dropper tip or let it touch your eye or any||
2030|026|H|other surface.||
2030|027|H|   If you are wearing contact lenses, remove them before using||
2030|028|H|eye drops. Wait at least 15 minutes before replacing your contact||
2030|029|H|lenses. Tilt your head back, look upward, and pull down the lower||
2030|030|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2030|031|H|and place one drop into the pouch. Look downward, gently close||
2030|032|H|your eyes, and place one finger at the corner of your eye (near||
2030|033|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2030|034|H|opening your eyes. This will prevent the medication from draining||
2030|035|H|out. Try not to blink or rub your eye. If directed to use this||
2030|036|H|medication in both eyes, repeat these steps for your other eye.||
2030|037|H|Do not rinse the dropper. Replace the dropper cap after each use.||
2030|038|H|   If you are using another kind of eye medication (such as drops||
2030|039|H|or ointments), wait at least 5 minutes before applying other||
2030|040|H|medications. Use eye drops before eye ointments to allow the||
2030|041|H|drops to enter the eye.||
2030|042|H|   Wait several minutes for your vision to clear before driving||
2030|043|H|or operating machinery.||
2030|044|H|   Use this medication regularly to get the most benefit from it.||
2030|045|H|To help you remember, use it at the same time each day. Keep||
2030|046|H|using netarsudil/latanoprost even if you feel well. Most people||
2030|047|H|with glaucoma or high pressure in the eye do not have symptoms.||
2030|048|B|||
2030|049|S|SIDE EFFECTS:  Eye discomfort/redness/itching, increased tears,||
2030|050|S|temporary blurred vision, changes in eyelash||
2030|051|S|number/color/length/thickness, eyelid changes/skin darkening, or||
2030|052|S|corneal staining may occur. If any of these effects last or get||
2030|053|S|worse, tell your doctor or pharmacist promptly.||
2030|054|S|   This medication may slowly (over months to years) cause the||
2030|055|S|colored portion of the eye (iris) to turn brown. If you are using||
2030|056|S|this medication in only one eye, only that iris may change color.||
2030|057|S|This color change may be permanent but the long-term effects are||
2030|058|S|uncertain. Tell your doctor if this occurs and schedule regular||
2030|059|S|eye exams to monitor it.||
2030|060|S|   Remember that this medication has been prescribed because your||
2030|061|S|doctor has judged that the benefit to you is greater than the||
2030|062|S|risk of side effects. Many people using this medication do not||
2030|063|S|have serious side effects.||
2030|064|S|   Tell your doctor right away if you have any serious side||
2030|065|S|effects, including: vision changes, eye pain, unusual redness or||
2030|066|S|swelling of the eyes/eyelids.||
2030|067|S|   A very serious allergic reaction to this drug is rare.||
2030|068|S|However, get medical help right away if you notice any symptoms||
2030|069|S|of a serious allergic reaction, including: rash, itching/swelling||
2030|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2030|071|S|breathing.||
2030|072|S|   This is not a complete list of possible side effects. If you||
2030|073|S|notice other effects not listed above, contact your doctor or||
2030|074|S|pharmacist.||
2030|075|S|   In the US -||
2030|076|S|   Call your doctor for medical advice about side effects. You||
2030|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2030|078|S|www.fda.gov/medwatch.||
2030|079|S|   In Canada - Call your doctor for medical advice about side||
2030|080|S|effects. You may report side effects to Health Canada at||
2030|081|S|1-866-234-2345.||
2030|082|B|||
2030|083|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2030|084|P|pharmacist if you are allergic to netarsudil or latanoprost; or||
2030|085|P|if you have any other allergies. This product may contain||
2030|086|P|inactive ingredients, which can cause allergic reactions or other||
2030|087|P|problems. Talk to your pharmacist for more details.||
2030|088|P|   Before using this medication, tell your doctor or pharmacist||
2030|089|P|your medical history, especially of: eye problems (such as||
2030|090|P|macular edema, iritis, uveitis, lens extraction/aphakia, herpes||
2030|091|P|infection of the eye).||
2030|092|P|   After you apply this drug, your vision may become temporarily||
2030|093|P|blurred. Do not drive, use machinery, or do anything that needs||
2030|094|P|clear vision until you can do it safely.||
2030|095|P|   If you develop an eye infection or injury, or have eye||
2030|096|P|surgery, ask your doctor if you should continue to use the||
2030|097|P|current bottle of this medication. You may be advised to start||
2030|098|P|using a new bottle.||
2030|099|P|   Before having surgery, tell your doctor or dentist about all||
2030|100|P|the products you use (including prescription drugs,||
2030|101|P|nonprescription drugs, and herbal products).||
2030|102|P|   During pregnancy, this medication should be used only when||
2030|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
2030|104|P|   It is unknown if this medication passes into breast milk.||
2030|105|P|Consult your doctor before breastfeeding.||
2030|106|B|||
2030|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2030|108|I|medications work or increase your risk for serious side effects.||
2030|109|I|This document does not contain all possible drug interactions.||
2030|110|I|Keep a list of all the products you use (including||
2030|111|I|prescription/nonprescription drugs and herbal products) and share||
2030|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2030|113|I|the dosage of any medicines without your doctor's approval.||
2030|114|I|   Some products that may interact with this drug are: eyelash||
2030|115|I|treatments (such as topically applied bimatoprost).||
2030|116|B|||
2030|117|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2030|118|O|has overdosed and has serious symptoms such as passing out or||
2030|119|O|trouble breathing, call 911. Otherwise, call a poison control||
2030|120|O|center right away. US residents can call 1-800-222-1222. Canada||
2030|121|O|residents can call 1-844-764-7669.||
2030|122|B|||
2030|123|N|NOTES:  Do not share this medication with others.||
2030|124|N|   Lab and/or medical tests (such as eye exams) should be done||
2030|125|N|while you are using this medication. Keep all medical and lab||
2030|126|N|appointments.||
2030|127|B|||
2030|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
2030|129|D|if it is on the same day. If you do not remember until the next||
2030|130|D|day, skip the missed dose. Use your next dose at the regular||
2030|131|D|time. Do not double the dose to catch up.||
2030|132|B|||
2030|133|R|STORAGE:  Store this medication in the refrigerator. Protect from||
2030|134|R|light. Keep all medications away from children and pets.||
2030|135|R|   Do not flush medications down the toilet or pour them into a||
2030|136|R|drain unless instructed to do so. Properly discard this product||
2030|137|R|when it is expired or no longer needed. Consult your pharmacist||
2030|138|R|or local waste disposal company.||
2030|139|B|||
2030|140|A|Information last revised May 2024.||
2030|141|A|Copyright(c) 2025 First Databank, Inc.||
2030|142|B|||
2031|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2031|002|Z|does NOT have all possible information about this product. This||
2031|003|Z|information does not assure that this product is safe, effective,||
2031|004|Z|or appropriate for you. This information is not individual||
2031|005|Z|medical advice and does not substitute for the advice of your||
2031|006|Z|health care professional. Always ask your health care||
2031|007|Z|professional for complete information about this product and your||
2031|008|Z|specific health needs.||
2031|009|B|||
2031|010|T|SIPONIMOD - ORAL||
2031|011|F|(si-PON-i-mod)||
2031|012|B|||
2031|013|C|COMMON BRAND NAME(S): Mayzent||
2031|014|B|||
2031|015|U|USES:  This medication is used to treat a certain type of||
2031|016|U|multiple sclerosis (relapsing multiple sclerosis-MS). Siponimod||
2031|017|U|is not a cure for MS but it is thought to help by preventing||
2031|018|U|immune system cells (lymphocytes) from attacking the nerves in||
2031|019|U|your brain and spinal cord. It helps decrease the number of||
2031|020|U|episodes of disease worsening (relapses) and may prevent or delay||
2031|021|U|disability.||
2031|022|B|||
2031|023|H|HOW TO USE:  Read the Medication Guide provided by your||
2031|024|H|pharmacist before you start taking siponimod and each time you||
2031|025|H|get a refill. If you have any questions, ask your doctor or||
2031|026|H|pharmacist.||
2031|027|H|   Take this medication by mouth with or without food as directed||
2031|028|H|by your doctor, usually once a day. Swallow the tablets whole. Do||
2031|029|H|not split, crush, or chew the tablets.||
2031|030|H|   The dosage is based on your medical condition and response to||
2031|031|H|treatment. To reduce your risk of side effects, your doctor may||
2031|032|H|direct you to start this medication at a low dose and gradually||
2031|033|H|increase your dose. Follow your doctor's instructions carefully.||
2031|034|H|   Do not stop taking this medication without consulting your||
2031|035|H|doctor. Your condition may become worse when this drug is||
2031|036|H|stopped. Tell your doctor right away if your MS symptoms are much||
2031|037|H|worse after stopping siponimod.||
2031|038|H|   Do not increase your dose or take this medication more often||
2031|039|H|than prescribed. Your condition will not improve any faster, and||
2031|040|H|your risk of side effects will increase.||
2031|041|H|   Take this medication regularly to get the most benefit from||
2031|042|H|it. To help you remember, take it at the same time each day.||
2031|043|H|   Tell your doctor if your condition gets worse.||
2031|044|B|||
2031|045|S|SIDE EFFECTS:  Headache or swelling of arms/legs may occur. If||
2031|046|S|either of these effects lasts or gets worse, tell your doctor or||
2031|047|S|pharmacist promptly.||
2031|048|S|   Slow heartbeat may also occur, especially when you first start||
2031|049|S|this medication. Some people may need to be monitored for at||
2031|050|S|least 6 hours after the first dose to make sure their heartbeat||
2031|051|S|does not go too slow. Ask your doctor for more details.||
2031|052|S|   Remember that this medication has been prescribed because your||
2031|053|S|doctor has judged that the benefit to you is greater than the||
2031|054|S|risk of side effects. Many people using this medication do not||
2031|055|S|have serious side effects.||
2031|056|S|   This medication may raise your blood pressure. Check your||
2031|057|S|blood pressure regularly and tell your doctor if the results are||
2031|058|S|high.||
2031|059|S|   Tell your doctor right away if you have any serious side||
2031|060|S|effects, including: signs of liver disease (such as||
2031|061|S|nausea/vomiting that doesn't stop, loss of appetite,||
2031|062|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2031|063|S|shortness of breath, unusual tiredness.||
2031|064|S|   Siponimod may rarely increase your risk of skin cancer. Tell||
2031|065|S|your doctor right away if you notice any unusual skin changes||
2031|066|S|(such as change in appearance/size of moles).||
2031|067|S|   This medication can weaken your immune system/increase the||
2031|068|S|risk of infection while you are taking it and for 3 to 4 weeks||
2031|069|S|after your last dose. You may be more likely to get a serious||
2031|070|S|(possibly fatal) infection (such as bronchitis, herpes). Tell||
2031|071|S|your doctor right away if you develop any signs of an infection||
2031|072|S|such as sore throat that doesn't go away, difficulty breathing,||
2031|073|S|fever, chills, cough, sores, or blisters. Do not start siponimod||
2031|074|S|if you already have an infection.||
2031|075|S|   This medication may increase your risk of getting a rare but||
2031|076|S|very serious (possibly fatal) brain infection (progressive||
2031|077|S|multifocal leukoencephalopathy-PML). Symptoms of PML can seem||
2031|078|S|like a worsening MS attack. Get medical help right away if you||
2031|079|S|have any of these side effects: clumsiness, loss of||
2031|080|S|coordination/balance, weakness, sudden change in your thinking||
2031|081|S|(such as confusion, difficulty concentrating, memory loss),||
2031|082|S|difficulty talking/walking, seizure.||
2031|083|S|   Get medical help right away if you have any very serious side||
2031|084|S|effects, including: very slow heartbeat, fast/irregular||
2031|085|S|heartbeat, severe dizziness, fainting, eye pain/sensitivity to||
2031|086|S|light, vision changes (such as blurred vision, blind spot/shadows||
2031|087|S|in the center of your vision, color changes), sudden/severe||
2031|088|S|headache, stiff/painful neck.||
2031|089|S|   A very serious allergic reaction to this drug is rare.||
2031|090|S|However, get medical help right away if you notice any symptoms||
2031|091|S|of a serious allergic reaction, including: rash, itching/swelling||
2031|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2031|093|S|breathing.||
2031|094|S|   This is not a complete list of possible side effects. If you||
2031|095|S|notice other effects not listed above, contact your doctor or||
2031|096|S|pharmacist.||
2031|097|S|   In the US -||
2031|098|S|   Call your doctor for medical advice about side effects. You||
2031|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2031|100|S|www.fda.gov/medwatch.||
2031|101|S|   In Canada - Call your doctor for medical advice about side||
2031|102|S|effects. You may report side effects to Health Canada at||
2031|103|S|1-866-234-2345.||
2031|104|B|||
2031|105|P|PRECAUTIONS:  Before taking siponimod, tell your doctor or||
2031|106|P|pharmacist if you are allergic to it; or if you have any other||
2031|107|P|allergies. This product may contain inactive ingredients (such as||
2031|108|P|soy) which can cause allergic reactions or other problems. Talk||
2031|109|P|to your pharmacist for more details.||
2031|110|P|   Before using this medication, tell your doctor or pharmacist||
2031|111|P|your medical history, especially of: breathing problems (such as||
2031|112|P|asthma, bronchitis, emphysema, sleep apnea),||
2031|113|P|current/recent/returning infection (including hepatitis and||
2031|114|P|tuberculosis), diabetes, certain eye problems (macular edema,||
2031|115|P|uveitis), heart problems (such as slow/irregular heartbeat, heart||
2031|116|P|failure, previous heart attack, chest pain, QT prolongation in||
2031|117|P|the EKG), high blood pressure, liver disease, stroke or||
2031|118|P|"mini-stroke"/transient ischemic attack (TIA).||
2031|119|P|   Have all necessary immunizations done before starting this||
2031|120|P|medication. Do not have immunizations/vaccinations without the||
2031|121|P|consent of your doctor while you are taking siponimod and for 4||
2031|122|P|weeks after your last dose. Also, stay away from anyone who has||
2031|123|P|an infection that may easily spread (such as chickenpox,||
2031|124|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2031|125|P|exposed to an infection or for more details.||
2031|126|P|   This medication may increase your risk of developing skin||
2031|127|P|cancer. Limit your time in the sun. Avoid tanning booths and||
2031|128|P|sunlamps. Use sunscreen and wear protective clothing when||
2031|129|P|outdoors. Your doctor may direct you to avoid phototherapy while||
2031|130|P|you use this product. Ask your doctor for details.||
2031|131|P|   Before having surgery, tell your doctor or dentist about all||
2031|132|P|the products you use (including prescription drugs,||
2031|133|P|nonprescription drugs, and herbal products).||
2031|134|P|   Tell your doctor if you are pregnant or plan to become||
2031|135|P|pregnant. You should not become pregnant while using siponimod.||
2031|136|P|Siponimod may harm an unborn baby. Ask about reliable forms of||
2031|137|P|birth control while using this medication and for 10 days after||
2031|138|P|the last dose. If you become pregnant, talk to your doctor right||
2031|139|P|away about the risks and benefits of this medication.||
2031|140|P|   It is unknown if this medication passes into breast milk.||
2031|141|P|Consult your doctor before breastfeeding.||
2031|142|B|||
2031|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2031|144|I|medications work or increase your risk for serious side effects.||
2031|145|I|This document does not contain all possible drug interactions.||
2031|146|I|Keep a list of all the products you use (including||
2031|147|I|prescription/nonprescription drugs and herbal products) and share||
2031|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
2031|149|I|the dosage of any medicines without your doctor's approval.||
2031|150|I|   Some of the products that may interact with this drug are:||
2031|151|I|other drugs that weaken the immune system/increase the risk of||
2031|152|I|infection (such as natalizumab, rituximab).||
2031|153|B|||
2031|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2031|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2031|156|O|poison control center right away. US residents can call||
2031|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2031|158|B|||
2031|159|N|NOTES:  Do not share this medication with others.||
2031|160|N|   Lab and/or medical tests (such as complete blood count, blood||
2031|161|N|pressure, pulse, EKG, MRI, eye/skin exams, liver/lung function)||
2031|162|N|should be done before you start taking this medication and while||
2031|163|N|you are taking it. Keep all medical and lab appointments. Consult||
2031|164|N|your doctor for more details.||
2031|165|B|||
2031|166|D|MISSED DOSE:  It is very important to follow your treatment||
2031|167|D|regimen exactly. Ask your doctor ahead of time what you should do||
2031|168|D|if you miss a dose of siponimod. If you miss a dose, you may need||
2031|169|D|to start at a lower dose again and slowly increase it. Do not||
2031|170|D|double the dose to catch up.||
2031|171|B|||
2031|172|R|STORAGE:  Store the unopened medication in the refrigerator away||
2031|173|R|from light and moisture. Store the opened medication at room||
2031|174|R|temperature. Do not refrigerate after opening. Do not store in||
2031|175|R|the bathroom. If this medication comes in a blister pack, keep||
2031|176|R|the medication in the blister pack until ready to use. Once the||
2031|177|R|container is opened or if the unopened container is stored at||
2031|178|R|room temperature, then this medication expires after 3 months.||
2031|179|R|Keep all medications away from children and pets.||
2031|180|R|   Do not flush medications down the toilet or pour them into a||
2031|181|R|drain unless instructed to do so. Properly discard this product||
2031|182|R|when it is expired or no longer needed. Consult your pharmacist||
2031|183|R|or local waste disposal company.||
2031|184|B|||
2031|185|A|Information last revised April 2025.||
2031|186|A|Copyright(c) 2025 First Databank, Inc.||
2031|187|B|||
2032|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2032|002|Z|does NOT have all possible information about this product. This||
2032|003|Z|information does not assure that this product is safe, effective,||
2032|004|Z|or appropriate for you. This information is not individual||
2032|005|Z|medical advice and does not substitute for the advice of your||
2032|006|Z|health care professional. Always ask your health care||
2032|007|Z|professional for complete information about this product and your||
2032|008|Z|specific health needs.||
2032|009|B|||
2032|010|T|LATANOPROST SOLUTION - OPHTHALMIC||
2032|011|F|(lay-TAN-oh-prost)||
2032|012|B|||
2032|013|C|COMMON BRAND NAME(S): Xalatan||
2032|014|B|||
2032|015|U|USES:  Latanoprost is used to treat high pressure inside the eye||
2032|016|U|due to glaucoma (open angle type) or other eye diseases (such as||
2032|017|U|ocular hypertension). It is similar to a natural chemical in the||
2032|018|U|body (prostaglandin) and works by regulating the flow of fluid||
2032|019|U|within the eye which results in lower pressure. Lowering high||
2032|020|U|pressure inside the eye helps to prevent blindness.||
2032|021|B|||
2032|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
2032|023|H|directed by your doctor, usually once daily in the evening. Do||
2032|024|H|not use latanoprost more often because it will not work as well.||
2032|025|H|   To apply eye drops, wash your hands first. To avoid||
2032|026|H|contamination, do not touch the dropper tip or let it touch your||
2032|027|H|eye or any other surface.||
2032|028|H|   If you are wearing contact lenses, remove them before using||
2032|029|H|this medication. Wait at least 15 minutes before replacing your||
2032|030|H|contact lenses.||
2032|031|H|   Tilt your head back, look upward, and pull down the lower||
2032|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2032|033|H|and place one drop into the pouch. Look downward, gently close||
2032|034|H|your eyes, and place one finger at the corner of your eye (near||
2032|035|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2032|036|H|opening your eyes. This will prevent the medication from draining||
2032|037|H|out. Try not to blink or rub your eye. Repeat these steps if your||
2032|038|H|dose is for more than one drop. If directed to use this||
2032|039|H|medication in both eyes, repeat these steps for your other eye.||
2032|040|H|Do not rinse the dropper. Replace the dropper cap after each use.||
2032|041|H|   Wait several minutes for your vision to clear before driving||
2032|042|H|or operating machinery.||
2032|043|H|   Use this medication regularly in order to get the most benefit||
2032|044|H|from it. Remember to use it at the same time each day. Keep using||
2032|045|H|latanoprost even if you feel well. Most people with glaucoma or||
2032|046|H|high pressure in the eye do not feel sick.||
2032|047|H|   If you are using another kind of eye medication (such as drops||
2032|048|H|or ointments), wait at least 5 minutes before applying other||
2032|049|H|products. Use eye drops before eye ointments to allow the eye||
2032|050|H|drops to enter the eye.||
2032|051|B|||
2032|052|S|SIDE EFFECTS:  Blurred vision, burning/stinging/itching/redness||
2032|053|S|of the eye, feeling as if something is in the eye, changes in||
2032|054|S|eyelash number/color/length/thickness, eyelid changes/skin||
2032|055|S|darkening, dry eye, lid crusting/discomfort, or increased||
2032|056|S|sensitivity to light may occur. If any of these effects last or||
2032|057|S|get worse, notify your doctor or pharmacist promptly.||
2032|058|S|   This medication may slowly (over months to years) cause brown||
2032|059|S|discoloration of the colored portion of the eye (iris). If you||
2032|060|S|are using latanoprost in only one eye, only that iris may change||
2032|061|S|color. This color change may be permanent but the long-term||
2032|062|S|effects are uncertain. Notify your doctor if this occurs and||
2032|063|S|schedule regular eye exams to monitor it.||
2032|064|S|   Remember that this medication has been prescribed because your||
2032|065|S|doctor has judged that the benefit to you is greater than the||
2032|066|S|risk of side effects. Many people using this medication do not||
2032|067|S|have serious side effects.||
2032|068|S|   Tell your doctor right away if you have any serious side||
2032|069|S|effects, including: eye pain, suspected eye infection (unusual||
2032|070|S|redness or swelling of eyes), rapid vision changes (such as loss||
2032|071|S|of vision).||
2032|072|S|   A very serious allergic reaction to this drug is rare.||
2032|073|S|However, get medical help right away if you notice any symptoms||
2032|074|S|of a serious allergic reaction, including: rash, severe||
2032|075|S|itching/swelling (especially of the face/tongue/throat),||
2032|076|S|dizziness, trouble breathing.||
2032|077|S|   This is not a complete list of possible side effects. If you||
2032|078|S|notice other effects not listed above, contact your doctor or||
2032|079|S|pharmacist.||
2032|080|S|   In the US -||
2032|081|S|   Call your doctor for medical advice about side effects. You||
2032|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2032|083|S|www.fda.gov/medwatch.||
2032|084|S|   In Canada - Call your doctor for medical advice about side||
2032|085|S|effects. You may report side effects to Health Canada at||
2032|086|S|1-866-234-2345.||
2032|087|B|||
2032|088|P|PRECAUTIONS:  Before using latanoprost, tell your doctor or||
2032|089|P|pharmacist if you are allergic to it; or if you have any other||
2032|090|P|allergies. This product may contain inactive ingredients (such as||
2032|091|P|preservatives like benzalkonium chloride), which can cause||
2032|092|P|allergic reactions or other problems. Talk to your pharmacist for||
2032|093|P|more details.||
2032|094|P|   Before using this medication, tell your doctor or pharmacist||
2032|095|P|your medical history, especially of: other eye problems (such as||
2032|096|P|macular edema, iritis/uveitis, lens extraction/aphakia, herpes||
2032|097|P|infection of the eye).||
2032|098|P|   If you develop an eye infection or injury, or have eye||
2032|099|P|surgery, check with your doctor about the continued use of your||
2032|100|P|current bottle of latanoprost. You may be advised to start using||
2032|101|P|a new bottle.||
2032|102|P|   After you apply this drug, your vision may become temporarily||
2032|103|P|blurred or unstable. Do not drive, use machinery, or do anything||
2032|104|P|that needs clear vision until you can do it safely.||
2032|105|P|   During pregnancy, this medication should be used only when||
2032|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
2032|107|P|   It is unknown if this medication passes into breast milk.||
2032|108|P|Consult your doctor before breastfeeding.||
2032|109|B|||
2032|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2032|111|I|medications work or increase your risk for serious side effects.||
2032|112|I|This document does not contain all possible drug interactions.||
2032|113|I|Keep a list of all the products you use (including||
2032|114|I|prescription/nonprescription drugs and herbal products) and share||
2032|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
2032|116|I|the dosage of any medicines without your doctor's approval.||
2032|117|I|   Some products that may interact with this drug are: eyelash||
2032|118|I|treatment (such as topically applied bimatoprost).||
2032|119|B|||
2032|120|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2032|121|O|has overdosed and has serious symptoms such as passing out or||
2032|122|O|trouble breathing, call 911. Otherwise, call a poison control||
2032|123|O|center right away. US residents can call 1-800-222-1222. Canada||
2032|124|O|residents can call 1-844-764-7669.||
2032|125|B|||
2032|126|N|NOTES:  Do not share this medication with others.||
2032|127|N|   Lab and/or medical tests (such as eye exams) should be done||
2032|128|N|while you are using this medication. Keep all medical and lab||
2032|129|N|appointments. Consult your doctor for more details.||
2032|130|B|||
2032|131|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
2032|132|D|if it is on the same day. If you do not remember until the next||
2032|133|D|day, skip the missed dose. Use your next dose at the regular||
2032|134|D|time. Do not double the dose to catch up.||
2032|135|B|||
2032|136|R|STORAGE:  Different brands of this medication have different||
2032|137|R|storage needs. Check the product package for instructions on how||
2032|138|R|to store your brand, or ask your pharmacist. Keep all medications||
2032|139|R|away from children and pets.||
2032|140|R|   Do not flush medications down the toilet or pour them into a||
2032|141|R|drain unless instructed to do so. Properly discard this product||
2032|142|R|when it is expired or no longer needed. Consult your pharmacist||
2032|143|R|or local waste disposal company.||
2032|144|B|||
2032|145|A|Information last revised May 2024.||
2032|146|A|Copyright(c) 2025 First Databank, Inc.||
2032|147|B|||
2033|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2033|002|Z|does NOT have all possible information about this product. This||
2033|003|Z|information does not assure that this product is safe, effective,||
2033|004|Z|or appropriate for you. This information is not individual||
2033|005|Z|medical advice and does not substitute for the advice of your||
2033|006|Z|health care professional. Always ask your health care||
2033|007|Z|professional for complete information about this product and your||
2033|008|Z|specific health needs.||
2033|009|B|||
2033|010|T|FAMOTIDINE - ORAL||
2033|011|F|(fam-OH-tih-dine)||
2033|012|B|||
2033|013|C|COMMON BRAND NAME(S): Pepcid, Zantac-360||
2033|014|B|||
2033|015|U|USES:  Famotidine is used to treat ulcers of the stomach and||
2033|016|U|intestines and to prevent intestinal ulcers from coming back||
2033|017|U|after they have healed. This medication is also used to treat||
2033|018|U|certain stomach and throat (esophagus) problems (such as erosive||
2033|019|U|esophagitis, gastroesophageal reflux disease-GERD,||
2033|020|U|Zollinger-Ellison syndrome). It works by decreasing the amount of||
2033|021|U|acid your stomach makes. It relieves symptoms such as cough that||
2033|022|U|doesn't go away, stomach pain, heartburn, and difficulty||
2033|023|U|swallowing. Famotidine belongs to a class of drugs known as H2||
2033|024|U|blockers.||
2033|025|U|   This medication is also available without a prescription. It||
2033|026|U|is used to prevent and treat heartburn and other symptoms caused||
2033|027|U|by too much acid in the stomach (acid indigestion). If you are||
2033|028|U|taking this medication for self-treatment, it is important to||
2033|029|U|read the manufacturer's package instructions carefully so you||
2033|030|U|know when to consult your doctor or pharmacist.||
2033|031|B|||
2033|032|H|HOW TO USE:  Take this medication by mouth with or without food||
2033|033|H|as directed by your doctor, usually once or twice daily. If you||
2033|034|H|are taking this medication once daily, it is usually taken right||
2033|035|H|before bedtime.||
2033|036|H|   The dosage and length of treatment are based on your medical||
2033|037|H|condition and response to treatment. Children's dosage may also||
2033|038|H|be based on weight. You may take other medications (such as||
2033|039|H|antacids) for your condition as recommended by your doctor.||
2033|040|H|Follow your doctor's instructions carefully. Consult your doctor||
2033|041|H|or pharmacist if you have any questions.||
2033|042|H|   Take this medication regularly in order to get the most||
2033|043|H|benefit from it. To help you remember, take it at the same||
2033|044|H|time(s) each day. Do not increase your dose or take it more often||
2033|045|H|than prescribed. Do not stop taking this medication without your||
2033|046|H|doctor's approval because this may delay healing of the ulcer.||
2033|047|H|   If you are using nonprescription famotidine for self-treatment||
2033|048|H|of acid indigestion or heartburn, take 1 tablet by mouth with a||
2033|049|H|glass of water as needed. To prevent heartburn, take 1 tablet by||
2033|050|H|mouth with a glass of water 15-60 minutes before eating food or||
2033|051|H|drinking beverages that cause heartburn. Do not use more than 2||
2033|052|H|tablets in 24 hours unless directed by your doctor. Do not take||
2033|053|H|for more than 14 days in a row without talking with your doctor.||
2033|054|H|   Tell your doctor if your condition does not get better or if||
2033|055|H|it gets worse.||
2033|056|B|||
2033|057|S|SIDE EFFECTS:  Headache, constipation, or diarrhea may occur. If||
2033|058|S|any of these effects last or get worse, tell your doctor or||
2033|059|S|pharmacist promptly.||
2033|060|S|   If your doctor has directed you to use this medication,||
2033|061|S|remember that your doctor has judged that the benefit to you is||
2033|062|S|greater than the risk of side effects. Many people using this||
2033|063|S|medication do not have serious side effects.||
2033|064|S|   Tell your doctor right away if you have any serious side||
2033|065|S|effects, including: easy bruising/bleeding, signs of infection||
2033|066|S|(such as sore throat that doesn't go away, fever, chills),||
2033|067|S|mental/mood changes (such as restlessness, confusion, depression,||
2033|068|S|hallucinations).||
2033|069|S|   Get medical help right away if you have any very serious side||
2033|070|S|effects, including: fast/slow/irregular heartbeat, severe||
2033|071|S|dizziness, fainting, seizure.||
2033|072|S|   A very serious allergic reaction to this drug is rare.||
2033|073|S|However, get medical help right away if you notice any symptoms||
2033|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2033|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2033|076|S|breathing.||
2033|077|S|   This is not a complete list of possible side effects. If you||
2033|078|S|notice other effects not listed above, contact your doctor or||
2033|079|S|pharmacist.||
2033|080|S|   In the US -||
2033|081|S|   Call your doctor for medical advice about side effects. You||
2033|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2033|083|S|www.fda.gov/medwatch.||
2033|084|S|   In Canada - Call your doctor for medical advice about side||
2033|085|S|effects. You may report side effects to Health Canada at||
2033|086|S|1-866-234-2345.||
2033|087|B|||
2033|088|P|PRECAUTIONS:  Before taking famotidine, tell your doctor or||
2033|089|P|pharmacist if you are allergic to it; or to other H2 blockers||
2033|090|P|(such as cimetidine, ranitidine); or if you have any other||
2033|091|P|allergies. This product may contain inactive ingredients, which||
2033|092|P|can cause allergic reactions or other problems. Talk to your||
2033|093|P|pharmacist for more details.||
2033|094|P|   Before using this medication, tell your doctor or pharmacist||
2033|095|P|your medical history, especially of: immune system problems,||
2033|096|P|kidney problems, liver problems, lung problems (such as asthma,||
2033|097|P|chronic obstructive pulmonary disease-COPD), other stomach||
2033|098|P|problems (such as tumors).||
2033|099|P|   Some symptoms may actually be signs of a more serious||
2033|100|P|condition. Get medical help right away if you have: heartburn||
2033|101|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
2033|102|P|pain (especially with shortness of breath, unusual sweating),||
2033|103|P|unexplained weight loss.||
2033|104|P|   In addition, before you self-treat with this medication, get||
2033|105|P|medical help right away if you have any of these signs of a||
2033|106|P|serious condition: trouble/pain swallowing food, bloody vomit,||
2033|107|P|vomit that looks like coffee grounds, bloody/black stools,||
2033|108|P|heartburn for over 3 months, frequent chest pain, frequent||
2033|109|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
2033|110|P|pain.||
2033|111|P|   Do not use to treat children younger than 12 unless directed||
2033|112|P|by the doctor.||
2033|113|P|   Older adults may be more sensitive to the side effects of this||
2033|114|P|drug, especially mental/mood changes (such as confusion),||
2033|115|P|seizure, or unusual tiredness.||
2033|116|P|   During pregnancy, famotidine should be used only when clearly||
2033|117|P|needed. Discuss the risks and benefits with your doctor.||
2033|118|P|   This drug passes into breast milk. Consult your doctor before||
2033|119|P|breastfeeding.||
2033|120|B|||
2033|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2033|122|I|medications work or increase your risk for serious side effects.||
2033|123|I|This document does not contain all possible drug interactions.||
2033|124|I|Keep a list of all the products you use (including||
2033|125|I|prescription/nonprescription drugs and herbal products) and share||
2033|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
2033|127|I|the dosage of any medicines without your doctor's approval.||
2033|128|I|   A product that may interact with this drug is: fezolinetant.||
2033|129|I|   Some products need stomach acid so that the body can absorb||
2033|130|I|them properly. Famotidine decreases stomach acid, so it may||
2033|131|I|change how well these products work. Some affected products||
2033|132|I|include atazanavir, dasatinib, certain azole antifungals (such as||
2033|133|I|itraconazole, ketoconazole), levoketoconazole, pazopanib,||
2033|134|I|sparsentan, among others.||
2033|135|I|   Do not take this medication with other products that contain||
2033|136|I|famotidine or other H2 blockers (cimetidine, nizatidine,||
2033|137|I|ranitidine).||
2033|138|B|||
2033|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2033|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2033|141|O|poison control center right away. US residents can call||
2033|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2033|143|B|||
2033|144|N|NOTES:  Do not share this medication with others.||
2033|145|N|   Lifestyle changes such as stress reduction programs, stopping||
2033|146|N|smoking, limiting alcohol, and diet changes (such as avoiding||
2033|147|N|caffeine and certain spices) may help this medication work||
2033|148|N|better. Talk to your doctor or pharmacist about lifestyle changes||
2033|149|N|that might benefit you.||
2033|150|N|   Lab and/or medical tests (such as endoscopy, kidney function)||
2033|151|N|may be done while you are taking this medication. Keep all||
2033|152|N|medical and lab appointments. Consult your doctor for more||
2033|153|N|details.||
2033|154|B|||
2033|155|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2033|156|D|remember. If it is near the time of the next dose, skip the||
2033|157|D|missed dose. Take your next dose at the regular time. Do not||
2033|158|D|double the dose to catch up.||
2033|159|B|||
2033|160|R|STORAGE:  Store at room temperature away from light and moisture.||
2033|161|R|Do not store in the bathroom. Keep all medications away from||
2033|162|R|children and pets.||
2033|163|R|   Do not flush medications down the toilet or pour them into a||
2033|164|R|drain unless instructed to do so. Properly discard this product||
2033|165|R|when it is expired or no longer needed. Consult your pharmacist||
2033|166|R|or local waste disposal company.||
2033|167|B|||
2033|168|A|Information last revised October 2024.||
2033|169|A|Copyright(c) 2025 First Databank, Inc.||
2033|170|B|||
2034|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2034|002|Z|does NOT have all possible information about this product. This||
2034|003|Z|information does not assure that this product is safe, effective,||
2034|004|Z|or appropriate for you. This information is not individual||
2034|005|Z|medical advice and does not substitute for the advice of your||
2034|006|Z|health care professional. Always ask your health care||
2034|007|Z|professional for complete information about this product and your||
2034|008|Z|specific health needs.||
2034|009|B|||
2034|010|T|RISPERIDONE - ORAL||
2034|011|F|(riss-PAIR-ih-doan)||
2034|012|B|||
2034|013|C|COMMON BRAND NAME(S): Risperdal||
2034|014|B|||
2034|015|W|WARNING:  There may be a slightly increased risk of serious,||
2034|016|W|possibly fatal side effects (such as stroke, heart failure,||
2034|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
2034|018|W|by older adults with dementia. This medication is not approved||
2034|019|W|for the treatment of dementia-related behavior problems. Discuss||
2034|020|W|the risks and benefits of this medication, as well as other||
2034|021|W|effective and possibly safer treatments for dementia-related||
2034|022|W|behavior problems, with the doctor.||
2034|023|W|   If you are using risperidone in combination with other||
2034|024|W|medication to treat depression, also carefully read the drug||
2034|025|W|information for the other medication.||
2034|026|B|||
2034|027|U|USES:  This medication is used to treat certain mental/mood||
2034|028|U|disorders (such as schizophrenia, bipolar disorder, irritability||
2034|029|U|associated with autistic disorder). Risperidone belongs to a||
2034|030|U|class of drugs known as atypical antipsychotics. It works by||
2034|031|U|helping to restore the balance of certain natural substances in||
2034|032|U|the brain.||
2034|033|B|||
2034|034|V|OTHER USES:  This section contains uses of this drug that are not||
2034|035|V|listed in the approved professional labeling for the drug but||
2034|036|V|that may be prescribed by your health care professional. Use this||
2034|037|V|drug for a condition that is listed in this section only if it||
2034|038|V|has been so prescribed by your health care professional.||
2034|039|V|   This medication may also be used for other mental/mood||
2034|040|V|disorders (such as obsessive-compulsive disorder, depression).||
2034|041|B|||
2034|042|H|HOW TO USE:  Take this medication by mouth with or without food||
2034|043|H|as directed by your doctor, usually once or twice daily.||
2034|044|H|   If you are using the liquid form of this medication, read the||
2034|045|H|Instructions for Use if available from your pharmacist before you||
2034|046|H|start using risperidone and each time you get a refill. Carefully||
2034|047|H|measure the dose using the special measuring device that is||
2034|048|H|provided. Do not use a household spoon because you may not get||
2034|049|H|the correct dose. If directed, you may mix the measured dose with||
2034|050|H|a small amount of liquid (3 to 4 ounces/about 100 milliliters)||
2034|051|H|such as water, coffee, orange juice, or low-fat milk. Do not mix||
2034|052|H|with cola or tea. Take all of the mixture right away. Do not||
2034|053|H|prepare a supply in advance. Consult your pharmacist if you have||
2034|054|H|any questions.||
2034|055|H|   The dosage is based on your age, medical condition, response||
2034|056|H|to treatment, and other medications you may be taking. Be sure to||
2034|057|H|tell your doctor and pharmacist about all the products you use||
2034|058|H|(including prescription drugs, nonprescription drugs, and herbal||
2034|059|H|products). To reduce your risk of side effects, your doctor may||
2034|060|H|direct you to start this medication at a low dose and gradually||
2034|061|H|increase your dose. Follow your doctor's instructions carefully.||
2034|062|H|   Take this medication regularly to get the most benefit from||
2034|063|H|it. To help you remember, take it at the same time(s) each day.||
2034|064|H|Keep taking this medication even if you feel well. Do not stop||
2034|065|H|taking this medication without consulting your doctor.||
2034|066|H|   Tell your doctor if your condition lasts or gets worse.||
2034|067|B|||
2034|068|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, drooling,||
2034|069|S|nausea, weight gain, or tiredness may occur. If any of these||
2034|070|S|effects last or get worse, tell your doctor or pharmacist||
2034|071|S|promptly.||
2034|072|S|   Dizziness and lightheadedness can increase the risk of||
2034|073|S|falling. Get up slowly when rising from a sitting or lying||
2034|074|S|position.||
2034|075|S|   Remember that this medication has been prescribed because your||
2034|076|S|doctor has judged that the benefit to you is greater than the||
2034|077|S|risk of side effects. Many people using this medication do not||
2034|078|S|have serious side effects.||
2034|079|S|   Tell your doctor right away if you have any serious side||
2034|080|S|effects, including: difficulty swallowing, muscle spasms, shaking||
2034|081|S|(tremor), mental/mood changes (such as anxiety, restlessness),||
2034|082|S|interrupted breathing during sleep.||
2034|083|S|   This medication may rarely make your blood sugar rise, which||
2034|084|S|can cause or worsen diabetes. Tell your doctor right away if you||
2034|085|S|have symptoms of high blood sugar such as increased||
2034|086|S|thirst/urination. If you already have diabetes, check your blood||
2034|087|S|sugar regularly as directed and share the results with your||
2034|088|S|doctor. Your doctor may need to adjust your diabetes medication,||
2034|089|S|exercise program, or diet.||
2034|090|S|   This drug may also cause significant weight gain and a rise in||
2034|091|S|your blood cholesterol (or triglyceride) levels. These effects,||
2034|092|S|along with diabetes, may increase your risk for developing heart||
2034|093|S|disease. Discuss the risks and benefits of treatment with your||
2034|094|S|doctor. (See also Notes section.)||
2034|095|S|   Risperidone may rarely cause a condition known as tardive||
2034|096|S|dyskinesia. In some cases, this condition may be permanent. Tell||
2034|097|S|your doctor right away if you develop any unusual/uncontrolled||
2034|098|S|movements (especially of the face, lips, mouth, tongue, arms or||
2034|099|S|legs).||
2034|100|S|   This medication may increase a certain natural substance||
2034|101|S|(prolactin) made by your body. For females, this increase in||
2034|102|S|prolactin may result in unwanted breast milk, missed/stopped||
2034|103|S|periods, or difficulty becoming pregnant. For males, it may||
2034|104|S|result in decreased sexual ability, inability to produce sperm,||
2034|105|S|or enlarged breasts. If you develop any of these symptoms, tell||
2034|106|S|your doctor right away.||
2034|107|S|   Get medical help right away if you have any very serious side||
2034|108|S|effects, including: severe dizziness, fainting, seizures.||
2034|109|S|   This medication may rarely cause a very serious condition||
2034|110|S|called neuroleptic malignant syndrome (NMS). Get medical help||
2034|111|S|right away if you have any of the following symptoms: fever,||
2034|112|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
2034|113|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
2034|114|S|signs of kidney problems (such as change in the amount of urine).||
2034|115|S|   Rarely, males may have a painful or prolonged erection lasting||
2034|116|S|4 or more hours. If this occurs, stop using this drug and get||
2034|117|S|medical help right away, or permanent problems could occur.||
2034|118|S|   A very serious allergic reaction to this drug is rare.||
2034|119|S|However, get medical help right away if you notice any symptoms||
2034|120|S|of a serious allergic reaction, including: fever, swollen lymph||
2034|121|S|nodes, rash, itching/swelling (especially of the||
2034|122|S|face/tongue/throat), severe dizziness, trouble breathing.||
2034|123|S|   This is not a complete list of possible side effects. If you||
2034|124|S|notice other effects not listed above, contact your doctor or||
2034|125|S|pharmacist.||
2034|126|S|   In the US -||
2034|127|S|   Call your doctor for medical advice about side effects. You||
2034|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2034|129|S|www.fda.gov/medwatch.||
2034|130|S|   In Canada - Call your doctor for medical advice about side||
2034|131|S|effects. You may report side effects to Health Canada at||
2034|132|S|1-866-234-2345.||
2034|133|B|||
2034|134|P|PRECAUTIONS:  Before taking risperidone, tell your doctor or||
2034|135|P|pharmacist if you are allergic to it; or to paliperidone; or if||
2034|136|P|you have any other allergies. This product may contain inactive||
2034|137|P|ingredients, which can cause allergic reactions or other||
2034|138|P|problems. Talk to your pharmacist for more details.||
2034|139|P|   Before using this medication, tell your doctor or pharmacist||
2034|140|P|your medical history, especially of: liver disease, kidney||
2034|141|P|disease, seizures, difficulty swallowing, low white blood cell||
2034|142|P|count, Parkinson's disease, dementia, certain eye problems||
2034|143|P|(cataracts, glaucoma), personal or family history of diabetes,||
2034|144|P|heart disease, high cholesterol/triglyceride levels, breathing||
2034|145|P|trouble during sleep (sleep apnea).||
2034|146|P|   Risperidone may cause a condition that affects the heart||
2034|147|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2034|148|P|serious (rarely fatal) fast/irregular heartbeat and other||
2034|149|P|symptoms (such as severe dizziness, fainting) that need medical||
2034|150|P|attention right away.||
2034|151|P|   The risk of QT prolongation may be increased if you have||
2034|152|P|certain medical conditions or are taking other drugs that may||
2034|153|P|cause QT prolongation. Before using risperidone, tell your doctor||
2034|154|P|or pharmacist of all the drugs you take and if you have any of||
2034|155|P|the following conditions: certain heart problems (heart failure,||
2034|156|P|slow heartbeat, QT prolongation in the EKG), family history of||
2034|157|P|certain heart problems (QT prolongation in the EKG, sudden||
2034|158|P|cardiac death).||
2034|159|P|   Low levels of potassium or magnesium in the blood may also||
2034|160|P|increase your risk of QT prolongation. This risk may increase if||
2034|161|P|you use certain drugs (such as diuretics/"water pills") or if you||
2034|162|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2034|163|P|Talk to your doctor about using risperidone safely.||
2034|164|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2034|165|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2034|166|P|machinery, or do anything that needs alertness until you can do||
2034|167|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2034|168|P|are using marijuana (cannabis).||
2034|169|P|   Before having surgery (including cataract/glaucoma eye||
2034|170|P|surgery), tell your doctor or dentist if you are taking or have||
2034|171|P|ever taken this medication, and about all the other products you||
2034|172|P|use (including prescription drugs, nonprescription drugs, and||
2034|173|P|herbal products).||
2034|174|P|   This medication may make you sweat less, making you more||
2034|175|P|likely to get heat stroke. Avoid doing things that may cause you||
2034|176|P|to overheat, such as hard work or exercise in hot weather, or||
2034|177|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2034|178|P|and dress lightly. If you overheat, quickly look for a place to||
2034|179|P|cool down and rest. Get medical help right away if you have a||
2034|180|P|fever that does not go away, mental/mood changes, headache, or||
2034|181|P|dizziness.||
2034|182|P|   Older adults may be more sensitive to the side effects of this||
2034|183|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
2034|184|P|prolongation (see above). Drowsiness, dizziness, and||
2034|185|P|lightheadedness can increase the risk of falling.||
2034|186|P|   During pregnancy, this medication should be used only when||
2034|187|P|clearly needed. Babies born to mothers who have used this drug||
2034|188|P|during the last 3 months of pregnancy may rarely develop symptoms||
2034|189|P|including muscle stiffness or shakiness, drowsiness,||
2034|190|P|feeding/breathing difficulties, or constant crying. If you notice||
2034|191|P|any of these symptoms in your newborn especially during their||
2034|192|P|first month, tell the doctor right away.||
2034|193|P|   Since untreated mental/mood problems (such as schizophrenia,||
2034|194|P|bipolar disorder, depression) can be a serious condition, do not||
2034|195|P|stop taking this medication unless directed by your doctor. If||
2034|196|P|you are planning pregnancy, become pregnant, or think you may be||
2034|197|P|pregnant, immediately discuss with your doctor the benefits and||
2034|198|P|risks of using this medication during pregnancy.||
2034|199|P|   This medication passes into breast milk and may have||
2034|200|P|undesirable effects on a nursing infant. Tell the doctor right||
2034|201|P|away if your baby develops symptoms such as muscle stiffness or||
2034|202|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
2034|203|P|your doctor before breastfeeding.||
2034|204|B|||
2034|205|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2034|206|I|medications work or increase your risk for serious side effects.||
2034|207|I|This document does not contain all possible drug interactions.||
2034|208|I|Keep a list of all the products you use (including||
2034|209|I|prescription/nonprescription drugs and herbal products) and share||
2034|210|I|it with your doctor and pharmacist. Do not start, stop, or change||
2034|211|I|the dosage of any medicines without your doctor's approval.||
2034|212|I|   A product that may interact with this drug is: metoclopramide.||
2034|213|I|   Tell your doctor or pharmacist if you are taking other||
2034|214|I|products that cause drowsiness such as opioid pain or cough||
2034|215|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2034|216|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2034|217|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2034|218|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2034|219|I|diphenhydramine).||
2034|220|I|   Check the labels on all your medicines (such as allergy or||
2034|221|I|cough-and-cold products) because they may contain ingredients||
2034|222|I|that cause drowsiness. Ask your pharmacist about using those||
2034|223|I|products safely.||
2034|224|B|||
2034|225|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2034|226|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2034|227|O|poison control center right away. US residents can call||
2034|228|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2034|229|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
2034|230|O|fast/irregular heartbeat, unusual/uncontrolled movements,||
2034|231|O|seizures.||
2034|232|B|||
2034|233|N|NOTES:  Do not share this medication with others.||
2034|234|N|   Lab and/or medical tests (such as blood sugar, weight, blood||
2034|235|N|pressure, blood cholesterol/triglyceride levels) should be done||
2034|236|N|while you are taking this medication. Keep all medical and lab||
2034|237|N|appointments. Consult your doctor for more details.||
2034|238|B|||
2034|239|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2034|240|D|remember. If it is near the time of the next dose, skip the||
2034|241|D|missed dose. Take your next dose at the regular time. Do not||
2034|242|D|double the dose to catch up.||
2034|243|B|||
2034|244|R|STORAGE:  Store at room temperature away from light and moisture.||
2034|245|R|Do not freeze the liquid form of this medication. Do not store in||
2034|246|R|the bathroom. Keep all medications away from children and pets.||
2034|247|R|   Do not flush medications down the toilet or pour them into a||
2034|248|R|drain unless instructed to do so. Properly discard this product||
2034|249|R|when it is expired or no longer needed. Consult your pharmacist||
2034|250|R|or local waste disposal company.||
2034|251|B|||
2034|252|A|Information last revised May 2024.||
2034|253|A|Copyright(c) 2025 First Databank, Inc.||
2034|254|B|||
2035|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2035|002|Z|does NOT have all possible information about this product. This||
2035|003|Z|information does not assure that this product is safe, effective,||
2035|004|Z|or appropriate for you. This information is not individual||
2035|005|Z|medical advice and does not substitute for the advice of your||
2035|006|Z|health care professional. Always ask your health care||
2035|007|Z|professional for complete information about this product and your||
2035|008|Z|specific health needs.||
2035|009|B|||
2035|010|T|DOLUTEGRAVIR/LAMIVUDINE - ORAL||
2035|011|F|(DOE-loo-TEG-ra-vir/la-MIV-ue-deen)||
2035|012|B|||
2035|013|C|COMMON BRAND NAME(S): Dovato||
2035|014|B|||
2035|015|W|WARNING:  Patients should be tested for hepatitis B infection||
2035|016|W|before starting this medication. If you have hepatitis B||
2035|017|W|infection and HIV, you may need additional drugs to treat the||
2035|018|W|hepatitis B infection. You may also have a serious worsening of||
2035|019|W|hepatitis symptoms if you stop taking lamivudine. Talk with your||
2035|020|W|doctor before stopping this medication. Your doctor will monitor||
2035|021|W|liver tests for several months after you stop lamivudine. Get||
2035|022|W|medical help right away if you develop symptoms of worsening||
2035|023|W|liver problems.||
2035|024|B|||
2035|025|U|USES:  This product contains 2 drugs: dolutegravir and||
2035|026|U|lamivudine. It is used to help control HIV infection. It helps to||
2035|027|U|decrease the amount of HIV in your body so your immune system can||
2035|028|U|work better. This lowers your chance of getting HIV complications||
2035|029|U|(such as new infections, cancer) and improves your quality of||
2035|030|U|life. Lamivudine belongs to a class of drugs known as nucleoside||
2035|031|U|reverse transcriptase inhibitors (NRTIs). Dolutegravir belongs to||
2035|032|U|a class of drugs known as integrase inhibitors.||
2035|033|U|   This medication is not a cure for HIV infection. To decrease||
2035|034|U|your risk of spreading HIV disease to others, continue to take||
2035|035|U|all HIV medications exactly as prescribed by your doctor. Use an||
2035|036|U|effective barrier method (latex or polyurethane condoms/dental||
2035|037|U|dams) during sexual activity as directed by your doctor. Do not||
2035|038|U|share personal items (such as needles/syringes, toothbrushes, and||
2035|039|U|razors) that may have contacted blood or other body fluids.||
2035|040|U|Consult your doctor or pharmacist for more details.||
2035|041|B|||
2035|042|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2035|043|H|from your pharmacist before you start taking this product and||
2035|044|H|each time you get a refill. If you have any questions, ask your||
2035|045|H|doctor or pharmacist.||
2035|046|H|   Take this medication by mouth with or without food as directed||
2035|047|H|by your doctor, usually once daily. If you are taking certain||
2035|048|H|other medications, your doctor may direct you to take additional||
2035|049|H|dolutegravir. Carefully follow your doctor's directions.||
2035|050|H|   Take this medication at least 2 hours before or 6 hours after||
2035|051|H|taking sucralfate and products containing aluminum or magnesium||
2035|052|H|(such as antacids, laxatives, buffered medications). These||
2035|053|H|products bind with dolutegravir, decreasing its effectiveness.||
2035|054|H|   If you are also taking calcium or iron supplements (including||
2035|055|H|vitamins/minerals that contain calcium or iron), take this||
2035|056|H|medication at least 2 hours before or 6 hours after these||
2035|057|H|products. Or if you take this medication with food, you can take||
2035|058|H|the supplements at the same time.||
2035|059|H|   It is very important to keep taking this medication exactly as||
2035|060|H|prescribed by your doctor. Do not skip any doses.||
2035|061|H|   For the best effect, take this medication at evenly spaced||
2035|062|H|times. To help you remember, take this medication at the same||
2035|063|H|time every day.||
2035|064|H|   Do not take more or less of this drug than prescribed or stop||
2035|065|H|taking it even for a short time unless directed to do so by your||
2035|066|H|doctor. Doing so may cause the amount of virus to increase, make||
2035|067|H|the infection more difficult to treat (resistant), or worsen side||
2035|068|H|effects.||
2035|069|B|||
2035|070|S|SIDE EFFECTS:  Headache or trouble sleeping may occur. If either||
2035|071|S|of these effects lasts or gets worse, tell your doctor or||
2035|072|S|pharmacist promptly.||
2035|073|S|   Remember that this medication has been prescribed because your||
2035|074|S|doctor has judged that the benefit to you is greater than the||
2035|075|S|risk of side effects. Many people using this medication do not||
2035|076|S|have serious side effects.||
2035|077|S|   As your immune system gets stronger, it can begin to fight off||
2035|078|S|infections you already had, possibly causing disease symptoms to||
2035|079|S|come back. You could also have symptoms if your immune system||
2035|080|S|becomes overactive. This reaction may happen at any time (soon||
2035|081|S|after starting HIV treatment or many months later). Tell your||
2035|082|S|doctor right away if you have any serious symptoms, including:||
2035|083|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
2035|084|S|that doesn't go away, headaches that are severe or don't go away,||
2035|085|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
2035|086|S|changes, signs of infection (such as sore throat that doesn't go||
2035|087|S|away, fever, chills, swollen lymph nodes, non-healing skin||
2035|088|S|sores), signs of an overactive thyroid (such as irritability,||
2035|089|S|nervousness, heat intolerance, fast/pounding/irregular heartbeat.||
2035|090|S|   Tell your doctor right away if you have any serious side||
2035|091|S|effects, including: mental/mood changes (such as depression,||
2035|092|S|anxiety), signs of kidney problems (such as change in the amount||
2035|093|S|of urine).||
2035|094|S|   Rarely, this medication has caused severe (sometimes fatal)||
2035|095|S|liver problems and a buildup of lactic acid in the blood (lactic||
2035|096|S|acidosis). These serious side effects may occur more often in||
2035|097|S|women and obese patients. Get medical help right away if you have||
2035|098|S|any of the following serious symptoms, including: symptoms of||
2035|099|S|liver problems (such as nausea/vomiting that doesn't stop, loss||
2035|100|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2035|101|S|urine), symptoms of lactic acidosis (such as deep/rapid||
2035|102|S|breathing, drowsiness, nausea/vomiting).||
2035|103|S|   A very serious allergic reaction to this drug is rare.||
2035|104|S|However, get medical help right away if you notice any symptoms||
2035|105|S|of a serious allergic reaction, including: rash, itching/swelling||
2035|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2035|107|S|breathing.||
2035|108|S|   This is not a complete list of possible side effects. If you||
2035|109|S|notice other effects not listed above, contact your doctor or||
2035|110|S|pharmacist.||
2035|111|S|   In the US -||
2035|112|S|   Call your doctor for medical advice about side effects. You||
2035|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2035|114|S|www.fda.gov/medwatch.||
2035|115|S|   In Canada - Call your doctor for medical advice about side||
2035|116|S|effects. You may report side effects to Health Canada at||
2035|117|S|1-866-234-2345.||
2035|118|B|||
2035|119|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2035|120|P|pharmacist if you are allergic to dolutegravir or lamivudine; or||
2035|121|P|if you have any other allergies. This product may contain||
2035|122|P|inactive ingredients, which can cause allergic reactions or other||
2035|123|P|problems. Talk to your pharmacist for more details.||
2035|124|P|   Before using this medication, tell your doctor or pharmacist||
2035|125|P|your medical history, especially of: kidney problems, liver||
2035|126|P|problems (such as hepatitis B or C).||
2035|127|P|   Limit alcoholic beverages, because they can increase the risk||
2035|128|P|of liver problems.||
2035|129|P|   Before having surgery, tell your doctor or dentist about all||
2035|130|P|the products you use (including prescription drugs,||
2035|131|P|nonprescription drugs, and herbal products).||
2035|132|P|   Tell your doctor if you are pregnant before using this||
2035|133|P|medication. Treatment can lower the risk of passing HIV infection||
2035|134|P|to your baby. Discuss the risks and benefits with your doctor.||
2035|135|P|   This medication passes into breast milk. Because breast milk||
2035|136|P|may transmit HIV, consult your doctor before breastfeeding.||
2035|137|B|||
2035|138|I|DRUG INTERACTIONS:  See also How to Use section.||
2035|139|I|   Drug interactions may change how your medications work or||
2035|140|I|increase your risk for serious side effects. This document does||
2035|141|I|not contain all possible drug interactions. Keep a list of all||
2035|142|I|the products you use (including prescription/nonprescription||
2035|143|I|drugs and herbal products) and share it with your doctor and||
2035|144|I|pharmacist. Do not start, stop, or change the dosage of any||
2035|145|I|medicines without your doctor's approval.||
2035|146|I|   Some products that may interact with this drug are:||
2035|147|I|dofetilide, orlistat, sorbitol.||
2035|148|I|   Do not take this medication with other products (including||
2035|149|I|those that treat HIV infection) that contain lamivudine or||
2035|150|I|emtricitabine.||
2035|151|B|||
2035|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2035|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2035|154|O|poison control center right away. US residents can call||
2035|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2035|156|B|||
2035|157|N|NOTES:  Do not share this medication with others.||
2035|158|N|   Lab and/or medical tests (such as liver/kidney function, viral||
2035|159|N|load, T-cell counts) should be done while you are taking this||
2035|160|N|medication. Keep all medical and lab appointments. Consult your||
2035|161|N|doctor for more details.||
2035|162|B|||
2035|163|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2035|164|D|remember. If it is near the time of the next dose, skip the||
2035|165|D|missed dose. Take your next dose at the regular time. Do not||
2035|166|D|double the dose to catch up.||
2035|167|B|||
2035|168|R|STORAGE:  Store at room temperature away from light and moisture.||
2035|169|R|Do not store in the bathroom. Keep all medications away from||
2035|170|R|children and pets.||
2035|171|R|   Do not flush medications down the toilet or pour them into a||
2035|172|R|drain unless instructed to do so. Properly discard this product||
2035|173|R|when it is expired or no longer needed. Consult your pharmacist||
2035|174|R|or local waste disposal company.||
2035|175|B|||
2035|176|A|Information last revised April 2025.||
2035|177|A|Copyright(c) 2025 First Databank, Inc.||
2035|178|B|||
2036|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2036|002|Z|does NOT have all possible information about this product. This||
2036|003|Z|information does not assure that this product is safe, effective,||
2036|004|Z|or appropriate for you. This information is not individual||
2036|005|Z|medical advice and does not substitute for the advice of your||
2036|006|Z|health care professional. Always ask your health care||
2036|007|Z|professional for complete information about this product and your||
2036|008|Z|specific health needs.||
2036|009|B|||
2036|010|T|ERDAFITINIB - ORAL||
2036|011|F|(ER-da-FI-ti-nib)||
2036|012|B|||
2036|013|C|COMMON BRAND NAME(S): Balversa||
2036|014|B|||
2036|015|U|USES:  This medication is used to treat bladder cancer.||
2036|016|U|Erdafitinib belongs to a class of drugs known as kinase||
2036|017|U|inhibitors. It works by slowing or stopping the growth of cancer||
2036|018|U|cells that have a certain type of abnormal gene ("FGFR").||
2036|019|B|||
2036|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2036|021|H|from your pharmacist before you start taking erdafitinib and each||
2036|022|H|time you get a refill. If you have any questions, ask your doctor||
2036|023|H|or pharmacist.||
2036|024|H|   Take this medication by mouth with or without food as directed||
2036|025|H|by your doctor, usually once daily. Swallow the medication whole.||
2036|026|H|If you vomit after taking erdafitinib, do not take another dose||
2036|027|H|on the same day. Wait until the next day to take your regular||
2036|028|H|dose.||
2036|029|H|   Use this medication regularly to get the most benefit from it.||
2036|030|H|To help you remember, take it at the same time each day.||
2036|031|H|   The dosage is based on your medical condition and response to||
2036|032|H|treatment. Do not increase your dose or use this drug more often||
2036|033|H|or for longer than prescribed. Your condition will not improve||
2036|034|H|any faster, and your risk of serious side effects will increase.||
2036|035|H|   Since this drug can be absorbed through the skin and lungs and||
2036|036|H|may harm an unborn baby, women who are pregnant or who may become||
2036|037|H|pregnant should not handle this medication or breathe the dust||
2036|038|H|from the tablets.||
2036|039|B|||
2036|040|S|SIDE EFFECTS:  Nausea, vomiting, mouth sores/pain, change in how||
2036|041|S|food tastes, abdominal pain, diarrhea, constipation, loss of||
2036|042|S|appetite, weight loss, tiredness, dry mouth/skin, or muscle/joint||
2036|043|S|pain may occur. If any of these effects last or get worse, tell||
2036|044|S|your doctor or pharmacist promptly.||
2036|045|S|   Temporary hair loss may occur. Normal hair growth should||
2036|046|S|return after treatment has ended.||
2036|047|S|   People using this medication may have serious side effects.||
2036|048|S|However, you have been prescribed this drug because your doctor||
2036|049|S|has judged that the benefit to you is greater than the risk of||
2036|050|S|side effects. Careful monitoring by your doctor may decrease your||
2036|051|S|risk.||
2036|052|S|   Tell your doctor right away if you have any serious side||
2036|053|S|effects, including: nail problems (such as nail pain/bleeding,||
2036|054|S|lifting off the nail bed, changes in color or texture, infected||
2036|055|S|skin around the nail).||
2036|056|S|   Eye problems commonly occur, but can also be serious. To||
2036|057|S|prevent or treat dry eyes, use lubricating eye||
2036|058|S|drops/gels/ointments every 2 hours while you are awake. Tell your||
2036|059|S|doctor right away if you develop blurred/decreased vision or loss||
2036|060|S|of vision.||
2036|061|S|   This medication may cause your blood phosphate levels to||
2036|062|S|increase. Your doctor will check phosphate levels regularly||
2036|063|S|during treatment, and may adjust your dose of erdafitinib. You||
2036|064|S|may be asked to change your diet to limit the amount of phosphate||
2036|065|S|your body absorbs. You may also be prescribed other medication to||
2036|066|S|treat high phosphate levels. Tell your doctor right away if you||
2036|067|S|have symptoms of high phosphate levels, such as muscle cramps,||
2036|068|S|numbness/tingling around the mouth.||
2036|069|S|   Erdafitinib may make you develop a skin problem called||
2036|070|S|hand-foot syndrome. To help prevent this, protect your hands and||
2036|071|S|feet from heat or increased pressure. Avoid activities such as||
2036|072|S|using hot dishwater, taking tub baths, jogging, long walks, or||
2036|073|S|using garden or household tools such as screwdrivers. Symptoms||
2036|074|S|may include pain, swelling, redness, blisters, or numbness of the||
2036|075|S|hands/feet. Your doctor may prescribe medication (such as balm)||
2036|076|S|to help with symptoms. If symptoms affect your usual activities,||
2036|077|S|get medical help right away.||
2036|078|S|   For women of childbearing age, this medication may affect your||
2036|079|S|ability to have children. Ask your doctor for more details.||
2036|080|S|   A very serious allergic reaction to this drug is rare.||
2036|081|S|However, get medical help right away if you notice any symptoms||
2036|082|S|of a serious allergic reaction, including: rash, itching/swelling||
2036|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2036|084|S|breathing.||
2036|085|S|   This is not a complete list of possible side effects. If you||
2036|086|S|notice other effects not listed above, contact your doctor or||
2036|087|S|pharmacist.||
2036|088|S|   In the US -||
2036|089|S|   Call your doctor for medical advice about side effects. You||
2036|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2036|091|S|www.fda.gov/medwatch.||
2036|092|S|   In Canada - Call your doctor for medical advice about side||
2036|093|S|effects. You may report side effects to Health Canada at||
2036|094|S|1-866-234-2345.||
2036|095|B|||
2036|096|P|PRECAUTIONS:  Before taking erdafitinib, tell your doctor or||
2036|097|P|pharmacist if you are allergic to it; or if you have any other||
2036|098|P|allergies. This product may contain inactive ingredients, which||
2036|099|P|can cause allergic reactions or other problems. Talk to your||
2036|100|P|pharmacist for more details.||
2036|101|P|   Before using this medication, tell your doctor or pharmacist||
2036|102|P|your medical history, especially of: eye or vision problems,||
2036|103|P|kidney disease, liver disease.||
2036|104|P|   Before having surgery, tell your doctor or dentist about all||
2036|105|P|the products you use (including prescription drugs,||
2036|106|P|nonprescription drugs, and herbal products).||
2036|107|P|   Older adults may be more sensitive to the side effects of this||
2036|108|P|drug.||
2036|109|P|   Since this drug can be absorbed through the skin and lungs and||
2036|110|P|may harm an unborn baby, women who are pregnant or who may become||
2036|111|P|pregnant should not handle this medication or breathe the dust||
2036|112|P|from the tablets.||
2036|113|P|   Tell your doctor if you are pregnant or plan to become||
2036|114|P|pregnant. You should not become pregnant while using erdafitinib.||
2036|115|P|Erdafitinib may harm an unborn baby. Your doctor should order a||
2036|116|P|pregnancy test before you start this medication. Men and women||
2036|117|P|using this medication should ask about reliable forms of birth||
2036|118|P|control during treatment and for 1 month after the last dose. If||
2036|119|P|you or your partner becomes pregnant, talk to your doctor right||
2036|120|P|away about the risks and benefits of this medication.||
2036|121|P|   It is unknown if this medication passes into breast milk.||
2036|122|P|Because of the possible risk to the infant, breastfeeding is not||
2036|123|P|recommended while using this medication and for 1 month after the||
2036|124|P|last dose. Consult your doctor before breastfeeding.||
2036|125|B|||
2036|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2036|127|I|medications work or increase your risk for serious side effects.||
2036|128|I|This document does not contain all possible drug interactions.||
2036|129|I|Keep a list of all the products you use (including||
2036|130|I|prescription/nonprescription drugs and herbal products) and share||
2036|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
2036|132|I|the dosage of any medicines without your doctor's approval.||
2036|133|I|   Other medications can affect the removal of erdafitinib from||
2036|134|I|your body, which may affect how erdafitinib works. Examples||
2036|135|I|include rifamycins (such as rifabutin, rifampin), St. John's||
2036|136|I|wort, drugs used to treat seizures (such as carbamazepine,||
2036|137|I|phenytoin), among others.||
2036|138|B|||
2036|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2036|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2036|141|O|poison control center right away. US residents can call||
2036|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2036|143|B|||
2036|144|N|NOTES:  Do not share this medication with others.||
2036|145|N|   Lab and/or medical tests (such as eye exams, blood phosphate||
2036|146|N|levels, complete blood count, kidney/liver function) should be||
2036|147|N|done while you are taking this medication. Keep all medical and||
2036|148|N|lab appointments.||
2036|149|B|||
2036|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2036|151|D|remember. If you don't remember until the next day, skip the||
2036|152|D|missed dose. Take your next dose at the regular time. Do not||
2036|153|D|double the dose to catch up.||
2036|154|B|||
2036|155|R|STORAGE:  Store at room temperature away from light and moisture.||
2036|156|R|Do not store in the bathroom. Keep all medications away from||
2036|157|R|children and pets.||
2036|158|R|   Do not flush medications down the toilet or pour them into a||
2036|159|R|drain unless instructed to do so. Properly discard this product||
2036|160|R|when it is expired or no longer needed. Consult your pharmacist||
2036|161|R|or local waste disposal company.||
2036|162|B|||
2036|163|A|Information last revised May 2024.||
2036|164|A|Copyright(c) 2025 First Databank, Inc.||
2036|165|B|||
2037|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2037|002|Z|does NOT have all possible information about this product. This||
2037|003|Z|information does not assure that this product is safe, effective,||
2037|004|Z|or appropriate for you. This information is not individual||
2037|005|Z|medical advice and does not substitute for the advice of your||
2037|006|Z|health care professional. Always ask your health care||
2037|007|Z|professional for complete information about this product and your||
2037|008|Z|specific health needs.||
2037|009|B|||
2037|010|T|TRASTUZUMAB - SUBCUTANEOUS INJECTION||
2037|011|F|(tras-TOOZ-ue-mab)||
2037|012|B|||
2037|013|C|COMMON BRAND NAME(S): Herceptin Hylecta||
2037|014|B|||
2037|015|W|WARNING:  Trastuzumab may cause serious heart problems, including||
2037|016|W|heart failure. The risk of heart problems is increased if you||
2037|017|W|also use an anthracycline (such as doxorubicin). Your doctor may||
2037|018|W|stop treatment with this medication if heart problems occur. Tell||
2037|019|W|your doctor right away if you have any symptoms of heart failure||
2037|020|W|(such as shortness of breath, swelling ankles/feet, unusual||
2037|021|W|tiredness, unusual/sudden weight gain).||
2037|022|W|   Serious (possibly fatal) breathing problems may happen with||
2037|023|W|your injection, usually during or within 24 hours of the dose.||
2037|024|W|Get medical help right away if you have coughing or trouble||
2037|025|W|breathing.||
2037|026|W|   Trastuzumab can cause serious (possibly fatal) harm to an||
2037|027|W|unborn baby if used during pregnancy. Discuss reliable forms of||
2037|028|W|birth control with your doctor.||
2037|029|B|||
2037|030|U|USES:  Trastuzumab is used to treat breast cancer. Trastuzumab||
2037|031|U|belongs to a class of medications known as monoclonal antibodies.||
2037|032|U|It works by slowing or stopping the growth of cancer cells. This||
2037|033|U|product also contains hyaluronidase, which helps your body absorb||
2037|034|U|trastuzumab given by injection under the skin.||
2037|035|U|   This monograph is about the following trastuzumab products:||
2037|036|U|trastuzumab (subcutaneous) and trastuzumab-hyaluronidase-oysk.||
2037|037|U|These products are not the same as other trastuzumab products,||
2037|038|U|including trastuzumab emtansine, or trastuzumab given by||
2037|039|U|injection into a vein, and should not be used in place of each||
2037|040|U|other.||
2037|041|B|||
2037|042|H|HOW TO USE:  This medication is given by slow injection (over 2||
2037|043|H|to 5 minutes) under the skin by a health care professional. It is||
2037|044|H|given as directed by your doctor, usually once every 3 weeks. The||
2037|045|H|injection is given in the thigh and the injection site and side||
2037|046|H|are changed each time to lessen injury under the skin. The dosage||
2037|047|H|is based on your medical condition and response to treatment.||
2037|048|H|   Use this medication regularly to get the most benefit from it.||
2037|049|H|To help you remember, mark your calendar with a reminder.||
2037|050|H|   Serious reactions, including an allergic reaction, may happen||
2037|051|H|with your injection, usually within 24 hours after your dose.||
2037|052|H|Your doctor may prescribe other medications (such as||
2037|053|H|acetaminophen, diphenhydramine) before each dose to help prevent||
2037|054|H|these side effects. Get medical help right away if you have any||
2037|055|H|symptoms of serious reactions such as fever, chills, flushing,||
2037|056|H|headache, nausea/vomiting, coughing, chest pain, trouble||
2037|057|H|breathing, itching/swelling (especially of the||
2037|058|H|face/tongue/throat), dizziness, weakness, or feeling faint.||
2037|059|B|||
2037|060|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2037|061|S|   Redness/irritation at the injection site, diarrhea,||
2037|062|S|muscle/joint/back pain, stomach/abdominal pain, trouble sleeping,||
2037|063|S|mouth sores, and loss of appetite may occur. Headache, nausea,||
2037|064|S|and vomiting may also happen outside of the 24 hours after your||
2037|065|S|injection. Nausea and vomiting can be severe. In some cases, your||
2037|066|S|doctor may prescribe medication to prevent or relieve nausea and||
2037|067|S|vomiting. Eating several small meals, not eating before||
2037|068|S|treatment, or limiting activity may help lessen some of these||
2037|069|S|effects. If any of these effects last or get worse, tell your||
2037|070|S|doctor or pharmacist promptly.||
2037|071|S|   Remember that this medication has been prescribed because your||
2037|072|S|doctor has judged that the benefit to you is greater than the||
2037|073|S|risk of side effects. Many people using this medication do not||
2037|074|S|have serious side effects.||
2037|075|S|   Tell your doctor right away if you have any serious side||
2037|076|S|effects, including: bone pain, numbness/tingling, mental/mood||
2037|077|S|changes, fast/pounding heartbeat.||
2037|078|S|   This medication may raise your blood pressure. Check your||
2037|079|S|blood pressure regularly and tell your doctor if the results are||
2037|080|S|high.||
2037|081|S|   Get medical help right away if you have any very serious side||
2037|082|S|effects, including: weakness on one side of the body, trouble||
2037|083|S|speaking, vision changes, confusion.||
2037|084|S|   This medication may lower your ability to fight infections.||
2037|085|S|This may make you more likely to get a serious (rarely fatal)||
2037|086|S|infection or make any infection you have worse. Tell your doctor||
2037|087|S|right away if you have any signs of infection (such as sore||
2037|088|S|throat that doesn't go away, fever, chills).||
2037|089|S|   This medication can commonly cause a rash that is usually not||
2037|090|S|serious. However, you may not be able to tell it apart from a||
2037|091|S|rare rash that could be a sign of a severe reaction. Tell your||
2037|092|S|doctor right away if you develop any rash.||
2037|093|S|   A very serious allergic reaction to this drug is rare.||
2037|094|S|However, get medical help right away if you notice any symptoms||
2037|095|S|of a serious allergic reaction, including: rash, itching/swelling||
2037|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2037|097|S|breathing.||
2037|098|S|   This is not a complete list of possible side effects. If you||
2037|099|S|notice other effects not listed above, contact your doctor or||
2037|100|S|pharmacist.||
2037|101|S|   In the US -||
2037|102|S|   Call your doctor for medical advice about side effects. You||
2037|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2037|104|S|www.fda.gov/medwatch.||
2037|105|S|   In Canada - Call your doctor for medical advice about side||
2037|106|S|effects. You may report side effects to Health Canada at||
2037|107|S|1-866-234-2345.||
2037|108|B|||
2037|109|P|PRECAUTIONS:  See also Warning section.||
2037|110|P|   Before using subcutaneous trastuzumab, tell your doctor or||
2037|111|P|pharmacist if you are allergic to trastuzumab or hyaluronidase;||
2037|112|P|or to any trastuzumab, trastuzumab deruxtecan, or trastuzumab||
2037|113|P|emtansine products; or if you have any other allergies. This||
2037|114|P|product may contain inactive ingredients, which can cause||
2037|115|P|allergic reactions or other problems. Talk to your pharmacist for||
2037|116|P|more details.||
2037|117|P|   Before using this medication, tell your doctor or pharmacist||
2037|118|P|your medical history, especially of: current/recent infection,||
2037|119|P|heart problems (such as heart failure, irregular heartbeat), high||
2037|120|P|blood pressure, lung problems, previous cancer treatments||
2037|121|P|(including radiation treatment).||
2037|122|P|   This medication can make you more likely to get infections or||
2037|123|P|may make current infections worse. Stay away from anyone who has||
2037|124|P|an infection that may easily spread (such as chickenpox,||
2037|125|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2037|126|P|exposed to an infection or for more details.||
2037|127|P|   Tell your health care professional that you are using||
2037|128|P|trastuzumab before having any immunizations/vaccinations. Avoid||
2037|129|P|contact with people who have recently received live vaccines||
2037|130|P|(such as flu vaccine inhaled through the nose).||
2037|131|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2037|132|P|can make you more dizzy. Do not drive, use machinery, or do||
2037|133|P|anything that needs alertness until you can do it safely. Limit||
2037|134|P|alcoholic beverages. Talk to your doctor if you are using||
2037|135|P|marijuana (cannabis).||
2037|136|P|   Before having surgery, tell your doctor or dentist about all||
2037|137|P|the products you use (including prescription drugs,||
2037|138|P|nonprescription drugs, and herbal products).||
2037|139|P|   Older adults may be at greater risk for heart problems (such||
2037|140|P|as heart failure) while using this drug.||
2037|141|P|   Tell your doctor if you are pregnant or plan to become||
2037|142|P|pregnant. You should not become pregnant while using trastuzumab.||
2037|143|P|Trastuzumab may harm an unborn baby. Your doctor should order a||
2037|144|P|pregnancy test before you start this medication. Ask about||
2037|145|P|reliable forms of birth control while using this medication and||
2037|146|P|for 7 months after the last dose. If you become pregnant, talk to||
2037|147|P|your doctor right away about the risks and benefits of this||
2037|148|P|medication.||
2037|149|P|   It is unknown if this drug passes into breast milk. Consult||
2037|150|P|your doctor before breastfeeding while using this medication and||
2037|151|P|for 7 months after stopping treatment.||
2037|152|B|||
2037|153|I|DRUG INTERACTIONS:  See also Warning section.||
2037|154|I|   Drug interactions may change how your medications work or||
2037|155|I|increase your risk for serious side effects. This document does||
2037|156|I|not contain all possible drug interactions. Keep a list of all||
2037|157|I|the products you use (including prescription/nonprescription||
2037|158|I|drugs and herbal products) and share it with your doctor and||
2037|159|I|pharmacist. Do not start, stop, or change the dosage of any||
2037|160|I|medicines without your doctor's approval.||
2037|161|I|   Trastuzumab is very similar to trastuzumab deruxtecan and||
2037|162|I|trastuzumab emtansine. Do not use a trastuzumab deruxtecan or||
2037|163|I|trastuzumab emtansine product while using a trastuzumab product.||
2037|164|B|||
2037|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2037|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2037|167|O|poison control center right away. US residents can call||
2037|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2037|169|B|||
2037|170|N|NOTES:  Lab and/or medical tests (such as heart exams, complete||
2037|171|N|blood count, blood pressure) should be done before you start||
2037|172|N|using this medication and while you are using it. Keep all||
2037|173|N|medical and lab appointments.||
2037|174|B|||
2037|175|D|MISSED DOSE:  It is important to get each dose of this medication||
2037|176|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2037|177|D|right away for a new dosing schedule.||
2037|178|B|||
2037|179|R|STORAGE:  Not applicable. This medication is given in a hospital||
2037|180|R|or clinic and will not be stored at home.||
2037|181|B|||
2037|182|M|MEDICAL ALERT:  Your condition can cause complications in a||
2037|183|M|medical emergency. For information about enrolling in MedicAlert,||
2037|184|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2037|185|B|||
2037|186|A|Information last revised April 2025.||
2037|187|A|Copyright(c) 2025 First Databank, Inc.||
2037|188|B|||
2038|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2038|002|Z|does NOT have all possible information about this product. This||
2038|003|Z|information does not assure that this product is safe, effective,||
2038|004|Z|or appropriate for you. This information is not individual||
2038|005|Z|medical advice and does not substitute for the advice of your||
2038|006|Z|health care professional. Always ask your health care||
2038|007|Z|professional for complete information about this product and your||
2038|008|Z|specific health needs.||
2038|009|B|||
2038|010|T|CYANOCOBALAMIN - INJECTION||
2038|011|F|(SYE-an-oh-koe-BAL-a-min)||
2038|012|B|||
2038|013|C|COMMON BRAND NAME(S): Cobal, Cyanoject, Vitamin B-12||
2038|014|B|||
2038|015|U|USES:  Cyanocobalamin is a man-made form of vitamin B12 used to||
2038|016|U|treat low levels (deficiency) of this vitamin. Vitamin B12 helps||
2038|017|U|your body use fat and carbohydrates for energy and make new||
2038|018|U|protein. It is also important for normal blood, cells, and||
2038|019|U|nerves. Most people get enough vitamin B12 in their diet, but a||
2038|020|U|deficiency may occur in certain health conditions (such as poor||
2038|021|U|nutrition, stomach/intestinal problems, infection, cancer).||
2038|022|U|Serious vitamin B12 deficiency may result in anemia, stomach||
2038|023|U|problems, and nerve damage.||
2038|024|B|||
2038|025|H|HOW TO USE:  This medication is given by injection into a muscle||
2038|026|H|or under the skin as directed by your doctor. The dosage is based||
2038|027|H|on your medical condition and response to treatment. Injections||
2038|028|H|may be given daily when you first start treatment. Certain||
2038|029|H|medical conditions (such as pernicious anemia) may require you to||
2038|030|H|continue receiving injections every month.||
2038|031|H|   If you are using this medication at home, learn all||
2038|032|H|preparation and usage instructions from your health care||
2038|033|H|professional. Before using, check this product for particles or||
2038|034|H|discoloration. If either is present, do not use the liquid. Learn||
2038|035|H|how to store and discard medical supplies safely.||
2038|036|B|||
2038|037|S|SIDE EFFECTS:  Pain/redness at the injection site, mild diarrhea,||
2038|038|S|itching, or a feeling of swelling all over the body may occur. If||
2038|039|S|any of these effects last or get worse, tell your doctor or||
2038|040|S|pharmacist promptly.||
2038|041|S|   Remember that this medication has been prescribed because your||
2038|042|S|doctor has judged that the benefit to you is greater than the||
2038|043|S|risk of side effects. Many people using this medication do not||
2038|044|S|have serious side effects.||
2038|045|S|   This medication may cause low potassium levels in the blood||
2038|046|S|(hypokalemia). Tell your doctor right away if any of these||
2038|047|S|serious side effects occur: muscle cramps, weakness, irregular||
2038|048|S|heartbeat.||
2038|049|S|   People who have a rare blood disorder (polycythemia vera) may||
2038|050|S|rarely have symptoms related to this disorder while taking||
2038|051|S|cyanocobalamin. Get medical help right away if any of these very||
2038|052|S|serious symptoms occur: chest pain (especially with shortness of||
2038|053|S|breath), weakness on one side of the body, sudden vision changes,||
2038|054|S|trouble speaking.||
2038|055|S|   Get medical help right away if you have any very serious side||
2038|056|S|effects, including: symptoms of heart failure (such as shortness||
2038|057|S|of breath, swelling ankles/feet, unusual tiredness,||
2038|058|S|unusual/sudden weight gain).||
2038|059|S|   A very serious allergic reaction to this drug is rare.||
2038|060|S|However, get medical help right away if you notice any symptoms||
2038|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2038|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2038|063|S|breathing.||
2038|064|S|   This is not a complete list of possible side effects. If you||
2038|065|S|notice other effects not listed above, contact your doctor or||
2038|066|S|pharmacist.||
2038|067|S|   In the US -||
2038|068|S|   Call your doctor for medical advice about side effects. You||
2038|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2038|070|S|www.fda.gov/medwatch.||
2038|071|S|   In Canada - Call your doctor for medical advice about side||
2038|072|S|effects. You may report side effects to Health Canada at||
2038|073|S|1-866-234-2345.||
2038|074|B|||
2038|075|P|PRECAUTIONS:  Before using cyanocobalamin, tell your doctor or||
2038|076|P|pharmacist if you are allergic to it; or to cobalt; or if you||
2038|077|P|have any other allergies. Your doctor may recommend that you||
2038|078|P|receive a smaller test dose before starting your regular dose.||
2038|079|P|This product may contain inactive ingredients, which can cause||
2038|080|P|allergic reactions or other problems. Talk to your pharmacist for||
2038|081|P|more details.||
2038|082|P|   Before using this medication, tell your doctor or pharmacist||
2038|083|P|your medical history, especially of: low potassium blood levels||
2038|084|P|(hypokalemia), gout, kidney disease, a certain blood disorder||
2038|085|P|(polycythemia vera), a certain eye disease (Leber's disease),||
2038|086|P|other vitamin/mineral deficiencies (especially folic acid and||
2038|087|P|iron).||
2038|088|P|   Before having surgery, tell your doctor or dentist about all||
2038|089|P|the products you use (including prescription drugs,||
2038|090|P|nonprescription drugs, and herbal products).||
2038|091|P|   During pregnancy, this medication should be used only when||
2038|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
2038|093|P|   Based on information from related drugs, this medication may||
2038|094|P|pass into breast milk. Consult your doctor before breastfeeding.||
2038|095|B|||
2038|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2038|097|I|medications work or increase your risk for serious side effects.||
2038|098|I|This document does not contain all possible drug interactions.||
2038|099|I|Keep a list of all the products you use (including||
2038|100|I|prescription/nonprescription drugs and herbal products) and share||
2038|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
2038|102|I|the dosage of any medicines without your doctor's approval.||
2038|103|B|||
2038|104|O|OVERDOSE:  Overdose with this medication is very unlikely.||
2038|105|O|However, if someone has overdosed and has serious symptoms such||
2038|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2038|107|O|poison control center right away. US residents can call||
2038|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2038|109|B|||
2038|110|N|NOTES:  Do not share this medication with others.||
2038|111|N|   Lab and/or medical tests (such as blood potassium levels,||
2038|112|N|complete blood count, hematocrit, vitamin B12 levels) should be||
2038|113|N|done while you are using this medication. Keep all medical and||
2038|114|N|lab appointments. Consult your doctor for more details.||
2038|115|N|   This product is not a substitute for a proper diet. Remember||
2038|116|N|that it is best to get your vitamins from healthy foods. Vitamin||
2038|117|N|B12 is commonly found in many foods from animals, especially||
2038|118|N|liver, kidney, fish and shellfish, meat, and dairy foods.||
2038|119|B|||
2038|120|D|MISSED DOSE:  It is important to get each dose of this medication||
2038|121|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2038|122|D|right away for a new dosing schedule. Do not double the dose to||
2038|123|D|catch up.||
2038|124|B|||
2038|125|R|STORAGE:  Store at room temperature away from light. Do not||
2038|126|R|freeze. Keep all medications away from children and pets.||
2038|127|R|   Do not flush medications down the toilet or pour them into a||
2038|128|R|drain unless instructed to do so. Properly discard this product||
2038|129|R|when it is expired or no longer needed. Consult your pharmacist||
2038|130|R|or local waste disposal company.||
2038|131|B|||
2038|132|A|Information last revised October 2024.||
2038|133|A|Copyright(c) 2025 First Databank, Inc.||
2038|134|B|||
2039|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2039|002|Z|does NOT have all possible information about this product. This||
2039|003|Z|information does not assure that this product is safe, effective,||
2039|004|Z|or appropriate for you. This information is not individual||
2039|005|Z|medical advice and does not substitute for the advice of your||
2039|006|Z|health care professional. Always ask your health care||
2039|007|Z|professional for complete information about this product and your||
2039|008|Z|specific health needs.||
2039|009|B|||
2039|010|T|SODIUM SULFACETAMIDE SUSPENSION - TOPICAL (ACNE ONLY)||
2039|011|F|( SO-dee-um sull-fuh-SEET-uh-mide)||
2039|012|B|||
2039|013|C|COMMON BRAND NAME(S): Klaron||
2039|014|B|||
2039|015|U|USES:  This medication is used to treat acne. It works by||
2039|016|U|stopping the growth of certain bacteria on the skin that can||
2039|017|U|worsen acne. Sodium sulfacetamide belongs to a class of drugs||
2039|018|U|known as sulfa antibiotics.||
2039|019|B|||
2039|020|H|HOW TO USE:  This medication is for use on the skin only.||
2039|021|H|   Shake the container well before each use. With clean hands,||
2039|022|H|apply a thin film of the lotion to the areas of skin with acne as||
2039|023|H|directed by your doctor, usually twice daily. Wash your hands||
2039|024|H|with soap and water after each use.||
2039|025|H|   Avoid getting this medication in the eyes, nose, or mouth. If||
2039|026|H|you do get medication into these areas, rinse with plenty of||
2039|027|H|water.||
2039|028|H|   Use this medication regularly to get the most benefit from it.||
2039|029|H|Do not use large amounts of this medication, use it more often,||
2039|030|H|or use it for a longer time than prescribed. Your condition will||
2039|031|H|not improve any faster, and your risk of side effects may be||
2039|032|H|increased.||
2039|033|H|   Tell your doctor if your acne does not get better after a few||
2039|034|H|weeks or if it gets worse.||
2039|035|B|||
2039|036|S|SIDE EFFECTS:  Skin redness, irritation, stinging, and burning at||
2039|037|S|the application site may occur and lessen over time as your body||
2039|038|S|adjusts to the medication. If any of these effects last or get||
2039|039|S|worse, stop using this medication and tell your doctor or||
2039|040|S|pharmacist promptly.||
2039|041|S|   Remember that this medication has been prescribed because your||
2039|042|S|doctor has judged that the benefit to you is greater than the||
2039|043|S|risk of side effects. Many people using this medication do not||
2039|044|S|have serious side effects.||
2039|045|S|   Rarely, sodium sulfacetamide products applied to the skin may||
2039|046|S|be absorbed and may cause serious side effects. Stop using this||
2039|047|S|product and tell your doctor right away if you have any serious||
2039|048|S|side effects, including: aching/swollen joints, rash on nose and||
2039|049|S|cheeks, signs of infection (such as sore throat that doesn't go||
2039|050|S|away, fever, chills), signs of anemia (such as unusual||
2039|051|S|tiredness/weakness, rapid breathing, fast heartbeat), unusual||
2039|052|S|bleeding/bruising, signs of liver problems (such as nausea that||
2039|053|S|doesn't stop, dark urine, yellowing eyes/skin, stomach/abdominal||
2039|054|S|pain, vomiting), mouth sores.||
2039|055|S|   A very serious allergic reaction to this drug is rare.||
2039|056|S|However, get medical help right away if you notice any symptoms||
2039|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2039|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2039|059|S|breathing.||
2039|060|S|   This is not a complete list of possible side effects. If you||
2039|061|S|notice other effects not listed above, contact your doctor or||
2039|062|S|pharmacist.||
2039|063|S|   In the US -||
2039|064|S|   Call your doctor for medical advice about side effects. You||
2039|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2039|066|S|www.fda.gov/medwatch.||
2039|067|S|   In Canada - Call your doctor for medical advice about side||
2039|068|S|effects. You may report side effects to Health Canada at||
2039|069|S|1-866-234-2345.||
2039|070|B|||
2039|071|P|PRECAUTIONS:  Before using sulfacetamide lotion, tell your doctor||
2039|072|P|or pharmacist if you are allergic to it; or to sulfa antibiotics||
2039|073|P|(such as sulfamethoxazole); or if you have any other allergies.||
2039|074|P|This product may contain inactive ingredients (such as sulfites),||
2039|075|P|which can cause allergic reactions or other problems. Talk to||
2039|076|P|your pharmacist for more details.||
2039|077|P|   Before using this medication, tell your doctor or pharmacist||
2039|078|P|your medical history.||
2039|079|P|   Tell your doctor if there are areas of skin near where this||
2039|080|P|product will be applied that are cut, scraped, burned, or||
2039|081|P|infected. Injured skin may absorb more of this product, and the||
2039|082|P|chance of serious side effects may increase.||
2039|083|P|   Before having surgery, tell your doctor or dentist about all||
2039|084|P|the products you use (including prescription drugs,||
2039|085|P|nonprescription drugs, and herbal products).||
2039|086|P|   During pregnancy, this medication should be used only when||
2039|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
2039|088|P|   It is unknown if this drug passes into breast milk. Consult||
2039|089|P|your doctor before breastfeeding.||
2039|090|B|||
2039|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2039|092|I|medications work or increase your risk for serious side effects.||
2039|093|I|This document does not contain all possible drug interactions.||
2039|094|I|Keep a list of all the products you use (including||
2039|095|I|prescription/nonprescription drugs and herbal products) and share||
2039|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
2039|097|I|the dosage of any medicines without your doctor's approval.||
2039|098|I|   Some products that may interact with this drug are: skin||
2039|099|I|products containing silver.||
2039|100|B|||
2039|101|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2039|102|O|has overdosed and has serious symptoms such as passing out or||
2039|103|O|trouble breathing, call 911. Otherwise, call a poison control||
2039|104|O|center right away. US residents can call 1-800-222-1222. Canada||
2039|105|O|residents can call 1-844-764-7669.||
2039|106|B|||
2039|107|N|NOTES:  Do not share this medication with others.||
2039|108|N|   Keep all medical appointments.||
2039|109|B|||
2039|110|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2039|111|D|If it is near the time of the next dose, skip the missed dose.||
2039|112|D|Use your next dose at the regular time. Do not double the dose to||
2039|113|D|catch up.||
2039|114|B|||
2039|115|R|STORAGE:  Store at room temperature. Keep all medications away||
2039|116|R|from children and pets.||
2039|117|R|   Do not flush medications down the toilet or pour them into a||
2039|118|R|drain unless instructed to do so. Properly discard this product||
2039|119|R|when it is expired or no longer needed. Consult your pharmacist||
2039|120|R|or local waste disposal company.||
2039|121|B|||
2039|122|A|Information last revised April 2025.||
2039|123|A|Copyright(c) 2025 First Databank, Inc.||
2039|124|B|||
2040|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2040|002|Z|does NOT have all possible information about this product. This||
2040|003|Z|information does not assure that this product is safe, effective,||
2040|004|Z|or appropriate for you. This information is not individual||
2040|005|Z|medical advice and does not substitute for the advice of your||
2040|006|Z|health care professional. Always ask your health care||
2040|007|Z|professional for complete information about this product and your||
2040|008|Z|specific health needs.||
2040|009|B|||
2040|010|T|ROMOSOZUMAB - INJECTION||
2040|011|F|(ROE-moe-SOZ-ue-mab)||
2040|012|B|||
2040|013|C|COMMON BRAND NAME(S): Evenity||
2040|014|B|||
2040|015|W|WARNING:  This medication may rarely increase the risk for a||
2040|016|W|heart attack, stroke, or sudden death. Before starting treatment||
2040|017|W|with romosozumab, tell your doctor if you had a heart attack or||
2040|018|W|stroke within the past year. Get medical help right away if you||
2040|019|W|have symptoms of a heart attack (such as chest/jaw/left arm pain,||
2040|020|W|shortness of breath, unusual sweating) or signs of a stroke (such||
2040|021|W|as weakness on one side of the body, trouble speaking, sudden||
2040|022|W|vision changes, confusion).||
2040|023|B|||
2040|024|U|USES:  Romosozumab is used to treat bone loss (osteoporosis) for||
2040|025|U|women after menopause who are at high risk of having broken bones||
2040|026|U|(fractures). It works by increasing bone density and strength.||
2040|027|U|This effect helps to decrease the risk of having a fracture.||
2040|028|B|||
2040|029|H|HOW TO USE:  Read the Medication Guide provided by your||
2040|030|H|pharmacist before you start using romosozumab and each time you||
2040|031|H|get another dose. If you have any questions, ask your doctor or||
2040|032|H|pharmacist.||
2040|033|H|   This medication is given by injection under the skin by a||
2040|034|H|health care professional. It is given as directed by your doctor,||
2040|035|H|usually once a month.||
2040|036|H|   Use this medication regularly to get the most benefit from it.||
2040|037|H|Keep receiving this medication even if you feel well. Most people||
2040|038|H|with osteoporosis do not have symptoms. To help you remember,||
2040|039|H|mark your calendar with a reminder.||
2040|040|H|   According to the manufacturer, you should not use this drug||
2040|041|H|for longer than 12 months.||
2040|042|B|||
2040|043|S|SIDE EFFECTS:  See also Warning section.||
2040|044|S|   Joint pain may occur. If this effect lasts or gets worse, tell||
2040|045|S|your doctor or pharmacist promptly.||
2040|046|S|   Remember that this medication has been prescribed because your||
2040|047|S|doctor has judged that the benefit to you is greater than the||
2040|048|S|risk of side effects. Many people using this medication do not||
2040|049|S|have serious side effects.||
2040|050|S|   Tell your doctor right away if you have any serious side||
2040|051|S|effects, including: signs of low level of calcium in the blood||
2040|052|S|(such as muscle spasms, numbness/tingling of the hands/feet), new||
2040|053|S|or unusual hip/thigh/groin pain.||
2040|054|S|   A very serious allergic reaction to this drug is rare.||
2040|055|S|However, get medical help right away if you notice any symptoms||
2040|056|S|of a serious allergic reaction, including: rash, itching/swelling||
2040|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2040|058|S|breathing.||
2040|059|S|   This is not a complete list of possible side effects. If you||
2040|060|S|notice other effects not listed above, contact your doctor or||
2040|061|S|pharmacist.||
2040|062|S|   In the US -||
2040|063|S|   Call your doctor for medical advice about side effects. You||
2040|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2040|065|S|www.fda.gov/medwatch.||
2040|066|S|   In Canada - Call your doctor for medical advice about side||
2040|067|S|effects. You may report side effects to Health Canada at||
2040|068|S|1-866-234-2345.||
2040|069|B|||
2040|070|P|PRECAUTIONS:  See also Warning section.||
2040|071|P|   Before using romosozumab, tell your doctor or pharmacist if||
2040|072|P|you are allergic to it; or if you have any other allergies. This||
2040|073|P|product may contain inactive ingredients, which can cause||
2040|074|P|allergic reactions or other problems. Talk to your pharmacist for||
2040|075|P|more details.||
2040|076|P|   Before using this medication, tell your doctor or pharmacist||
2040|077|P|your medical history, especially of: low level of calcium in the||
2040|078|P|blood, heart problems (such as slow/irregular heartbeat, heart||
2040|079|P|failure, previous heart attack, chest pain), stroke or||
2040|080|P|"mini-stroke"/transient ischemic attack (TIA), kidney disease.||
2040|081|P|   Some people using romosozumab may have serious jawbone||
2040|082|P|problems. Your doctor should check your mouth before you start||
2040|083|P|this medication. Tell your dentist that you are using this||
2040|084|P|medication before you have any dental work done. To help prevent||
2040|085|P|jawbone problems, have regular dental exams and learn how to keep||
2040|086|P|your teeth and gums healthy. If you have jaw pain, tell your||
2040|087|P|doctor and dentist right away.||
2040|088|P|   Before having surgery (especially dental procedures), tell||
2040|089|P|your doctor and dentist about all the products you use (including||
2040|090|P|prescription drugs, nonprescription drugs, and herbal products).||
2040|091|P|Your doctor or dentist may tell you to stop using romosozumab||
2040|092|P|before your surgery. Ask for specific instructions about stopping||
2040|093|P|or starting this medication.||
2040|094|P|   This medication is not usually used by women of childbearing||
2040|095|P|age. It is unlikely to be used during pregnancy or breastfeeding.||
2040|096|P|Consult your doctor if you have any questions about this||
2040|097|P|medication.||
2040|098|B|||
2040|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2040|100|I|medications work or increase your risk for serious side effects.||
2040|101|I|This document does not contain all possible drug interactions.||
2040|102|I|Keep a list of all the products you use (including||
2040|103|I|prescription/nonprescription drugs and herbal products) and share||
2040|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
2040|105|I|the dosage of any medicines without your doctor's approval.||
2040|106|B|||
2040|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2040|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2040|109|O|poison control center right away. US residents can call||
2040|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2040|111|B|||
2040|112|N|NOTES:  Do not share this medication with others.||
2040|113|N|   Lab and/or medical tests (such as blood calcium level, bone||
2040|114|N|density) should be done while you are using this medication. Keep||
2040|115|N|all medical and lab appointments.||
2040|116|N|   Lifestyle changes that help promote healthy bones include||
2040|117|N|increasing weight-bearing exercise, stopping smoking, limiting||
2040|118|N|alcohol, and eating well-balanced meals that contain adequate||
2040|119|N|calcium and vitamin D. You may also need to take calcium and||
2040|120|N|vitamin D supplements. Consult your doctor for specific advice.||
2040|121|B|||
2040|122|D|MISSED DOSE:  It is important to get each dose of this medication||
2040|123|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2040|124|D|right away for a new dosing schedule.||
2040|125|B|||
2040|126|R|STORAGE:  Not applicable. This medication is given in a doctor's||
2040|127|R|office and will not be stored at home.||
2040|128|B|||
2040|129|A|Information last revised May 2024.||
2040|130|A|Copyright(c) 2025 First Databank, Inc.||
2040|131|B|||
2041|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2041|002|Z|does NOT have all possible information about this product. This||
2041|003|Z|information does not assure that this product is safe, effective,||
2041|004|Z|or appropriate for you. This information is not individual||
2041|005|Z|medical advice and does not substitute for the advice of your||
2041|006|Z|health care professional. Always ask your health care||
2041|007|Z|professional for complete information about this product and your||
2041|008|Z|specific health needs.||
2041|009|B|||
2041|010|T|ENTACAPONE - ORAL||
2041|011|F|(en-TACK-up-own)||
2041|012|B|||
2041|013|C|COMMON BRAND NAME(S): Comtan||
2041|014|B|||
2041|015|U|USES:  This medication is used with other medications||
2041|016|U|(levodopa/carbidopa) to treat Parkinson's disease. Entacapone||
2041|017|U|belongs to a class of drugs known as COMT inhibitors. Many people||
2041|018|U|taking levodopa for Parkinson's have problems with the effects of||
2041|019|U|the levodopa wearing off between scheduled doses, causing||
2041|020|U|symptoms to return or worsen. Entacapone blocks a certain natural||
2041|021|U|substance (COMT enzyme) that breaks down the levodopa in the||
2041|022|U|body. This effect allows the levodopa to last longer in the||
2041|023|U|system so that it doesn't wear off before the next dose.||
2041|024|B|||
2041|025|H|HOW TO USE:  Take this medication by mouth with or without food||
2041|026|H|as directed by your doctor, usually with each prescribed dose of||
2041|027|H|levodopa/carbidopa (up to 8 times daily).||
2041|028|H|   The dosage is based on your medical condition and response to||
2041|029|H|treatment.||
2041|030|H|   Use this medication regularly to get the most benefit from it.||
2041|031|H|To help you remember, take it at the same times each day. Do not||
2041|032|H|suddenly stop taking this medication unless instructed to do so||
2041|033|H|by your doctor. Doing so may cause your Parkinson's symptoms to||
2041|034|H|become much worse.||
2041|035|H|   Tell your doctor if your condition lasts or gets worse (such||
2041|036|H|as your Parkinson's symptoms are not controlled).||
2041|037|B|||
2041|038|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, unwanted/uncontrolled||
2041|039|S|movements, increased sweating, drowsiness, tiredness, dry mouth,||
2041|040|S|gas, and abdominal pain may occur. If any of these effects last||
2041|041|S|or get worse, tell your doctor or pharmacist promptly.||
2041|042|S|   Lightheadedness or dizziness upon standing may also occur,||
2041|043|S|especially during the first few weeks of treatment. To reduce the||
2041|044|S|risk of dizziness and lightheadedness, get up slowly when rising||
2041|045|S|from a sitting or lying position.||
2041|046|S|   Your urine may turn brownish-orange. This effect is harmless.||
2041|047|S|   Remember that this medication has been prescribed because your||
2041|048|S|doctor has judged that the benefit to you is greater than the||
2041|049|S|risk of side effects. Many people using this medication do not||
2041|050|S|have serious side effects.||
2041|051|S|   Some people taking entacapone have fallen asleep suddenly||
2041|052|S|during their usual daily activities (such as talking on the||
2041|053|S|phone, driving). In some cases, sleep occurred without any||
2041|054|S|feelings of drowsiness beforehand. This sleep effect may occur||
2041|055|S|anytime during treatment with entacapone even if you have used||
2041|056|S|this medication for a long time. If you experience increased||
2041|057|S|sleepiness or fall asleep during the day, do not drive or take||
2041|058|S|part in other possibly dangerous activities until you have||
2041|059|S|discussed this effect with your doctor. Your risk of this sleep||
2041|060|S|effect is increased by using alcohol or other medications that||
2041|061|S|can make you drowsy. See also Precautions section.||
2041|062|S|   Tell your doctor right away if you have any serious side||
2041|063|S|effects, including: diarrhea that doesn't stop, mental/mood||
2041|064|S|changes (such as confusion, hallucinations), unusual strong urges||
2041|065|S|(such as increased gambling, increased sexual urges), fever,||
2041|066|S|muscle stiffness, easy bleeding/bruising, sore/painful muscles,||
2041|067|S|muscle weakness, trouble breathing, pain with breathing.||
2041|068|S|   A very serious allergic reaction to this drug is rare.||
2041|069|S|However, get medical help right away if you notice any symptoms||
2041|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2041|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2041|072|S|breathing.||
2041|073|S|   This is not a complete list of possible side effects. If you||
2041|074|S|notice other effects not listed above, contact your doctor or||
2041|075|S|pharmacist.||
2041|076|S|   In the US -||
2041|077|S|   Call your doctor for medical advice about side effects. You||
2041|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2041|079|S|www.fda.gov/medwatch.||
2041|080|S|   In Canada - Call your doctor for medical advice about side||
2041|081|S|effects. You may report side effects to Health Canada at||
2041|082|S|1-866-234-2345.||
2041|083|B|||
2041|084|P|PRECAUTIONS:  Before taking entacapone, tell your doctor or||
2041|085|P|pharmacist if you are allergic to it; or if you have any other||
2041|086|P|allergies. This product may contain inactive ingredients, which||
2041|087|P|can cause allergic reactions or other problems. Talk to your||
2041|088|P|pharmacist for more details.||
2041|089|P|   Before using this medication, tell your doctor or pharmacist||
2041|090|P|your medical history, especially of: alcoholism, liver problems,||
2041|091|P|low blood pressure, mental/mood disorders (such as depression,||
2041|092|P|schizophrenia), sleep disorders.||
2041|093|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2041|094|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2041|095|P|machinery, or do anything that needs alertness until you can do||
2041|096|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2041|097|P|are using marijuana (cannabis). See also Side Effects section.||
2041|098|P|   Before having surgery, tell your doctor or dentist about all||
2041|099|P|the products you use (including prescription drugs,||
2041|100|P|nonprescription drugs, and herbal products).||
2041|101|P|   Older adults may be more sensitive to the side effects of this||
2041|102|P|drug, especially drowsiness and confusion.||
2041|103|P|   During pregnancy, this medication should be used only when||
2041|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
2041|105|P|   It is unknown if this drug passes into breast milk. Consult||
2041|106|P|your doctor before breastfeeding.||
2041|107|B|||
2041|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2041|109|I|medications work or increase your risk for serious side effects.||
2041|110|I|This document does not contain all possible drug interactions.||
2041|111|I|Keep a list of all the products you use (including||
2041|112|I|prescription/nonprescription drugs and herbal products) and share||
2041|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
2041|114|I|the dosage of any medicines without your doctor's approval.||
2041|115|I|   Some of the products that may interact with this drug include:||
2041|116|I|certain MAO inhibitors (isocarboxazid, linezolid, metaxalone,||
2041|117|I|methylene blue, moclobemide, phenelzine, procarbazine,||
2041|118|I|tranylcypromine).||
2041|119|I|   Other MAO inhibitors (safinamide, selegiline, rasagiline) may||
2041|120|I|be used cautiously with close monitoring by your doctor. If you||
2041|121|I|are taking rasagiline or selegiline for Parkinson's disease, ask||
2041|122|I|your doctor if you should keep taking it.||
2041|123|I|   Entacapone can slow down the removal of other drugs from your||
2041|124|I|body, thereby affecting how they work. These affected drugs||
2041|125|I|include apomorphine, dobutamine, and methyldopa. This is not a||
2041|126|I|complete list.||
2041|127|I|   Tell your doctor or pharmacist if you are taking other||
2041|128|I|products that cause drowsiness including alcohol, marijuana||
2041|129|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
2041|130|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
2041|131|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
2041|132|I|codeine).||
2041|133|I|   Check the labels on all your medicines (such as allergy or||
2041|134|I|cough-and-cold products) because they may contain ingredients||
2041|135|I|that cause drowsiness. Ask your pharmacist about using those||
2041|136|I|products safely.||
2041|137|B|||
2041|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2041|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2041|140|O|poison control center right away. US residents can call||
2041|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2041|142|O|Symptoms of overdose may include severe drowsiness, coma,||
2041|143|O|confusion, agitation.||
2041|144|B|||
2041|145|N|NOTES:  Do not share this medication with others.||
2041|146|N|   Lab and/or medical tests (such as liver function) should be||
2041|147|N|done while you are taking this medication. Keep all medical and||
2041|148|N|lab appointments. Consult your doctor for more details.||
2041|149|B|||
2041|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2041|151|D|remember. If it is near the time of the next dose, skip the||
2041|152|D|missed dose. Take your next dose at the regular time. Do not||
2041|153|D|double the dose to catch up.||
2041|154|B|||
2041|155|R|STORAGE:  Store at room temperature away from light and moisture.||
2041|156|R|Do not store in the bathroom. Keep all medications away from||
2041|157|R|children and pets.||
2041|158|R|   Do not flush medications down the toilet or pour them into a||
2041|159|R|drain unless instructed to do so. Properly discard this product||
2041|160|R|when it is expired or no longer needed. Consult your pharmacist||
2041|161|R|or local waste disposal company.||
2041|162|B|||
2041|163|A|Information last revised May 2024.||
2041|164|A|Copyright(c) 2025 First Databank, Inc.||
2041|165|B|||
2042|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2042|002|Z|does NOT have all possible information about this product. This||
2042|003|Z|information does not assure that this product is safe, effective,||
2042|004|Z|or appropriate for you. This information is not individual||
2042|005|Z|medical advice and does not substitute for the advice of your||
2042|006|Z|health care professional. Always ask your health care||
2042|007|Z|professional for complete information about this product and your||
2042|008|Z|specific health needs.||
2042|009|B|||
2042|010|T|RISANKIZUMAB - INJECTION||
2042|011|F|(RIS-an-KIZ-ue-mab)||
2042|012|B|||
2042|013|C|COMMON BRAND NAME(S): Skyrizi||
2042|014|B|||
2042|015|U|USES:  This medication is used to treat plaque psoriasis and||
2042|016|U|psoriatic arthritis. It is also used to treat certain bowel||
2042|017|U|diseases (Crohn's disease, ulcerative colitis). Risankizumab||
2042|018|U|belongs to a class of drugs known as monoclonal antibodies. It||
2042|019|U|works by blocking a certain natural protein in your body||
2042|020|U|(interleukin-23) that may cause inflammation and swelling.||
2042|021|B|||
2042|022|H|HOW TO USE:  Read the Medication Guide and the Instructions for||
2042|023|H|Use leaflet provided by your pharmacist before you start using||
2042|024|H|risankizumab and each time you get a refill. Ask your health care||
2042|025|H|professional how to prepare and use this medication. If you have||
2042|026|H|any questions, ask your doctor or pharmacist.||
2042|027|H|   Before treatment with this medication, your doctor will test||
2042|028|H|you for tuberculosis (TB). Your doctor should also monitor you||
2042|029|H|for symptoms of TB during and after treatment with this drug. If||
2042|030|H|needed, treatment for TB or other infections should be given||
2042|031|H|before using this medication.||
2042|032|H|   Inject this medication under the skin as directed by your||
2042|033|H|doctor. The injection is given in the thighs or abdomen (at least||
2042|034|H|2 inches from your belly button). For the prefilled syringe or||
2042|035|H|pen, it may also be given in the upper arms. If treating Crohn's||
2042|036|H|disease or ulcerative colitis, the first 3 doses of this||
2042|037|H|medication is given by injection into a vein by a healthcare||
2042|038|H|professional. The dosage and treatment schedule are based on your||
2042|039|H|medical condition and response to treatment. Follow your doctor's||
2042|040|H|directions carefully.||
2042|041|H|   Depending on your product, take the medication out of the||
2042|042|H|refrigerator at least 15 to 90 minutes before you inject it to||
2042|043|H|allow it to reach room temperature. Do not warm up this||
2042|044|H|medication any other way (for example, do not heat it in the||
2042|045|H|microwave or place it in hot water). Do not shake the medication.||
2042|046|H|The medication may contain a few clear or white particles. Before||
2042|047|H|using, check this product for cloudiness, large particles, or||
2042|048|H|discoloration. If you see any of these things, do not use the||
2042|049|H|liquid. Before injecting each dose, clean the skin you are going||
2042|050|H|to inject into (the injection site) with rubbing alcohol. Change||
2042|051|H|the injection site each time to lessen injury under the skin. Do||
2042|052|H|not inject into skin that is irritated, sore, bruised, red,||
2042|053|H|hardened, or affected by psoriasis, or into scars or stretch||
2042|054|H|marks. To lessen bruising, do not rub the injection site after a||
2042|055|H|shot. Learn how to store and discard medical supplies safely.||
2042|056|H|   Use this medication regularly to get the most benefit from it.||
2042|057|H|To help you remember, mark your calendar with a reminder.||
2042|058|H|   Tell your doctor if your condition does not get better or if||
2042|059|H|it gets worse.||
2042|060|B|||
2042|061|S|SIDE EFFECTS:  Headache or tiredness may occur. If either of||
2042|062|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2042|063|S|promptly.||
2042|064|S|   Remember that this medication has been prescribed because your||
2042|065|S|doctor has judged that the benefit to you is greater than the||
2042|066|S|risk of side effects. Many people using this medication do not||
2042|067|S|have serious side effects.||
2042|068|S|   This medication may lower your ability to fight infections.||
2042|069|S|This may make you more likely to get a serious infection or make||
2042|070|S|any infection you have worse. Tell your doctor right away if you||
2042|071|S|have any signs of infection (such as sore throat that doesn't go||
2042|072|S|away, fever, chills).||
2042|073|S|   If you are using this medication to treat Crohn's disease or||
2042|074|S|ulcerative colitis, risankizumab may rarely cause serious liver||
2042|075|S|disease. Get medical help right away if you have any symptoms of||
2042|076|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
2042|077|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2042|078|S|urine.||
2042|079|S|   A very serious allergic reaction to this drug is rare.||
2042|080|S|However, get medical help right away if you notice any symptoms||
2042|081|S|of a serious allergic reaction, including: rash, itching/swelling||
2042|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2042|083|S|breathing.||
2042|084|S|   This is not a complete list of possible side effects. If you||
2042|085|S|notice other effects not listed above, contact your doctor or||
2042|086|S|pharmacist.||
2042|087|S|   In the US -||
2042|088|S|   Call your doctor for medical advice about side effects. You||
2042|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2042|090|S|www.fda.gov/medwatch.||
2042|091|S|   In Canada - Call your doctor for medical advice about side||
2042|092|S|effects. You may report side effects to Health Canada at||
2042|093|S|1-866-234-2345.||
2042|094|B|||
2042|095|P|PRECAUTIONS:  Before using risankizumab, tell your doctor or||
2042|096|P|pharmacist if you are allergic to it; or if you have any other||
2042|097|P|allergies. This product may contain inactive ingredients which||
2042|098|P|can cause allergic reactions or other problems. Talk to your||
2042|099|P|pharmacist for more details.||
2042|100|P|   Before using this medication, tell your doctor or pharmacist||
2042|101|P|your medical history, especially of: current/recent/returning||
2042|102|P|infection (such as tuberculosis, herpes).||
2042|103|P|   Risankizumab can make you more likely to get infections||
2042|104|P|(including fungal skin infections) or may make current infections||
2042|105|P|worse. Stay away from anyone who has an infection that may easily||
2042|106|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2042|107|P|doctor if you have been exposed to an infection or for more||
2042|108|P|details.||
2042|109|P|   Tell your health care professional that you are using||
2042|110|P|risankizumab before having any immunizations/vaccinations. Avoid||
2042|111|P|contact with people who have recently received live vaccines||
2042|112|P|(such as flu vaccine inhaled through the nose).||
2042|113|P|   Before having surgery, tell your doctor or dentist about all||
2042|114|P|the products you use (including prescription drugs,||
2042|115|P|nonprescription drugs, and herbal products).||
2042|116|P|   During pregnancy, this medication should be used only when||
2042|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
2042|118|P|Mothers who have used this medication during pregnancy should ask||
2042|119|P|a doctor about immunizations/vaccinations for their newborn||
2042|120|P|babies.||
2042|121|P|   It is unknown if this medication passes into breast milk.||
2042|122|P|Consult your doctor before breastfeeding.||
2042|123|B|||
2042|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2042|125|I|medications work or increase your risk for serious side effects.||
2042|126|I|This document does not contain all possible drug interactions.||
2042|127|I|Keep a list of all the products you use (including||
2042|128|I|prescription/nonprescription drugs and herbal products) and share||
2042|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
2042|130|I|the dosage of any medicines without your doctor's approval.||
2042|131|B|||
2042|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2042|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2042|134|O|poison control center right away. US residents can call||
2042|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2042|136|B|||
2042|137|N|NOTES:  Do not share this medication with others.||
2042|138|N|   If you are using this medication to treat Crohn's disease or||
2042|139|N|ulcerative colitis, lab tests (such as liver function) should be||
2042|140|N|done before you start using this medication and while you are||
2042|141|N|using it. Keep all medical and lab appointments. Consult your||
2042|142|N|doctor for more details.||
2042|143|B|||
2042|144|D|MISSED DOSE:  It is important to get each dose of this medication||
2042|145|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2042|146|D|right away for a new dosing schedule. Do not double the dose to||
2042|147|D|catch up.||
2042|148|B|||
2042|149|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2042|150|R|medication in the original carton to protect from light. Keep all||
2042|151|R|medications away from children and pets.||
2042|152|R|   Do not flush medications down the toilet or pour them into a||
2042|153|R|drain unless instructed to do so. Properly discard this product||
2042|154|R|when it is expired or no longer needed. Consult your pharmacist||
2042|155|R|or local waste disposal company.||
2042|156|B|||
2042|157|A|Information last revised November 2025.||
2042|158|A|Copyright(c) 2025 First Databank, Inc.||
2042|159|B|||
2043|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2043|002|Z|does NOT have all possible information about this product. This||
2043|003|Z|information does not assure that this product is safe, effective,||
2043|004|Z|or appropriate for you. This information is not individual||
2043|005|Z|medical advice and does not substitute for the advice of your||
2043|006|Z|health care professional. Always ask your health care||
2043|007|Z|professional for complete information about this product and your||
2043|008|Z|specific health needs.||
2043|009|B|||
2043|010|T|FUROSEMIDE SOLUTION- ORAL||
2043|011|F|(fyou-ROW-seh-mide)||
2043|012|B|||
2043|013|C|COMMON BRAND NAME(S): Lasix||
2043|014|B|||
2043|015|W|WARNING:  Furosemide is a very potent medication. Using too much||
2043|016|W|of this drug can lead to serious water and salt/mineral loss. It||
2043|017|W|is important that you are closely monitored by your doctor while||
2043|018|W|taking this medication. Tell your doctor right away if you become||
2043|019|W|very thirsty or confused, or develop muscle cramps/weakness. See||
2043|020|W|also Side Effects section.||
2043|021|B|||
2043|022|U|USES:  Furosemide is used to reduce extra fluid in the body||
2043|023|U|(edema) caused by conditions such as heart failure, liver||
2043|024|U|disease, and kidney disease. This can lessen symptoms such as||
2043|025|U|shortness of breath and swelling in your arms, legs, and abdomen.||
2043|026|U|   This drug is also used to treat high blood pressure. Lowering||
2043|027|U|high blood pressure helps prevent strokes, heart attacks, and||
2043|028|U|kidney problems.||
2043|029|U|   Furosemide is a "water pill" (diuretic) that causes you to||
2043|030|U|make more urine. This helps your body get rid of extra water and||
2043|031|U|salt.||
2043|032|B|||
2043|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2043|034|H|from your pharmacist before you start taking furosemide and each||
2043|035|H|time you get a refill. If you have any questions, ask your doctor||
2043|036|H|or pharmacist.||
2043|037|H|   Take this medication by mouth as directed by your doctor, with||
2043|038|H|or without food, usually once or twice daily. It is best to avoid||
2043|039|H|taking this medication within 4 hours of your bedtime to prevent||
2043|040|H|having to get up to urinate. Carefully measure the dose using the||
2043|041|H|special measuring device/spoon that comes with your prescription.||
2043|042|H|Do not use a household spoon because you may not get the correct||
2043|043|H|dose.||
2043|044|H|   The dosage is based on your medical condition, age, and||
2043|045|H|response to treatment. Children's dosage is also based on weight.||
2043|046|H|Older adults usually start with a lower dose to decrease the risk||
2043|047|H|of side effects. Do not increase your dose or take it more often||
2043|048|H|than directed.||
2043|049|H|   Take this medication regularly in order to get the most||
2043|050|H|benefit from it. To help you remember, take it at the same||
2043|051|H|time(s) of the day as directed. Keep taking this medication even||
2043|052|H|if you feel well. Most people with high blood pressure do not||
2043|053|H|feel sick.||
2043|054|H|   Sucralfate, cholestyramine, and colestipol can decrease the||
2043|055|H|absorption of furosemide. If you are taking any of these drugs,||
2043|056|H|separate the timing of each dose from furosemide by at least 2||
2043|057|H|hours.||
2043|058|H|   Tell your doctor if your condition does not get better or if||
2043|059|H|it gets worse (for example, your blood pressure readings remain||
2043|060|H|high or increase).||
2043|061|B|||
2043|062|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, or blurred||
2043|063|S|vision may occur as your body adjusts to the medication. If any||
2043|064|S|of these effects last or get worse, tell your doctor or||
2043|065|S|pharmacist promptly.||
2043|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
2043|067|S|slowly when rising from a sitting or lying position.||
2043|068|S|   Remember that this medication has been prescribed because your||
2043|069|S|doctor has judged that the benefit to you is greater than the||
2043|070|S|risk of side effects. Many people using this medication do not||
2043|071|S|have serious side effects.||
2043|072|S|   This medication may cause dehydration and electrolyte||
2043|073|S|imbalance. Tell your doctor right away if you have any symptoms||
2043|074|S|of dehydration or electrolyte imbalance, including unusual dry||
2043|075|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
2043|076|S|heartbeat, or confusion.||
2043|077|S|   Tell your doctor right away if you have any serious side||
2043|078|S|effects, including: signs of kidney problems (such as change in||
2043|079|S|the amount of urine), fainting,||
2043|080|S|numbness/tingling/pain/redness/swelling of the arms/legs, hearing||
2043|081|S|changes (such as ringing in the ears, temporary or permanent||
2043|082|S|decreased hearing/deafness), signs of liver problems (such as||
2043|083|S|stomach/abdominal pain, yellowing eyes/skin).||
2043|084|S|   A very serious allergic reaction to this drug is rare.||
2043|085|S|However, get medical help right away if you notice any symptoms||
2043|086|S|of a serious allergic reaction, including: rash, itching/swelling||
2043|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2043|088|S|breathing.||
2043|089|S|   This is not a complete list of possible side effects. If you||
2043|090|S|notice other effects not listed above, contact your doctor or||
2043|091|S|pharmacist.||
2043|092|S|   In the US -||
2043|093|S|   Call your doctor for medical advice about side effects. You||
2043|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2043|095|S|www.fda.gov/medwatch.||
2043|096|S|   In Canada - Call your doctor for medical advice about side||
2043|097|S|effects. You may report side effects to Health Canada at||
2043|098|S|1-866-234-2345.||
2043|099|B|||
2043|100|P|PRECAUTIONS:  Before taking furosemide, tell your doctor or||
2043|101|P|pharmacist if you are allergic to it; or if you have any other||
2043|102|P|allergies. This product may contain inactive ingredients, which||
2043|103|P|can cause allergic reactions or other problems. Talk to your||
2043|104|P|pharmacist for more details.||
2043|105|P|   Before using this medication, tell your doctor or pharmacist||
2043|106|P|your medical history, especially of: kidney problems, liver||
2043|107|P|problems, inability to make urine, gout, lupus.||
2043|108|P|   If you have diabetes, furosemide may make it harder to control||
2043|109|P|your blood sugar. Check your blood sugar regularly as directed||
2043|110|P|and share the results with your doctor.||
2043|111|P|   Furosemide may reduce the potassium level in your blood. Your||
2043|112|P|doctor may instruct you to add potassium-rich foods to your diet||
2043|113|P|(such as bananas, orange juice) or prescribe potassium||
2043|114|P|supplements to prevent potassium loss. Ask your doctor for more||
2043|115|P|details.||
2043|116|P|   This medication may make you more sensitive to the sun. Limit||
2043|117|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2043|118|P|sunscreen and wear protective clothing when outdoors. Tell your||
2043|119|P|doctor right away if you get sunburned or have skin||
2043|120|P|blisters/redness.||
2043|121|P|   This drug may make you dizzy or blur your vision. Alcohol or||
2043|122|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
2043|123|P|machinery, or do anything that needs alertness or clear vision||
2043|124|P|until you can do it safely. Limit alcoholic beverages. Talk to||
2043|125|P|your doctor if you are using marijuana (cannabis).||
2043|126|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
2043|127|P|and cause you to feel lightheaded. Tell your doctor if you have||
2043|128|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
2043|129|P|of fluids unless your doctor tells you not to.||
2043|130|P|   Before having surgery, tell your doctor or dentist about all||
2043|131|P|the products you use (including prescription drugs,||
2043|132|P|nonprescription drugs, and herbal products).||
2043|133|P|   Babies born early (premature infants) and children may be more||
2043|134|P|sensitive to certain effects of this drug, such as kidney stones.||
2043|135|P|   Older adults may be more sensitive to the effects of this||
2043|136|P|drug, especially dizziness and water/mineral loss.||
2043|137|P|   During pregnancy, this medication should be used only when||
2043|138|P|clearly needed. Discuss the risks and benefits with your doctor.||
2043|139|P|   This drug passes into breast milk. Consult your doctor before||
2043|140|P|breastfeeding.||
2043|141|B|||
2043|142|I|DRUG INTERACTIONS:  See also the How to Use section.||
2043|143|I|   Drug interactions may change how your medications work or||
2043|144|I|increase your risk for serious side effects. This document does||
2043|145|I|not contain all possible drug interactions. Keep a list of all||
2043|146|I|the products you use (including prescription/nonprescription||
2043|147|I|drugs and herbal products) and share it with your doctor and||
2043|148|I|pharmacist. Do not start, stop, or change the dosage of any||
2043|149|I|medicines without your doctor's approval.||
2043|150|I|   Some products that may interact with this drug include:||
2043|151|I|desmopressin, ethacrynic acid, lithium.||
2043|152|I|   Some products have ingredients that could raise your blood||
2043|153|I|pressure or worsen your swelling. Tell your pharmacist what||
2043|154|I|products you are using, and ask how to use them safely||
2043|155|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
2043|156|I|ibuprofen/naproxen).||
2043|157|I|   This medication may interfere with certain lab tests (such as||
2043|158|I|thyroid hormone levels), possibly causing false test results.||
2043|159|I|Make sure lab personnel and all your doctors know you use this||
2043|160|I|drug.||
2043|161|B|||
2043|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2043|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2043|164|O|poison control center right away. US residents can call||
2043|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2043|166|O|Symptoms of overdose may include: fainting, severe weakness, a||
2043|167|O|severe decrease in the amount of urine.||
2043|168|B|||
2043|169|N|NOTES:  Do not share this medication with others.||
2043|170|N|   Lifestyle changes that may help this medication work better||
2043|171|N|include exercising, stopping smoking, reducing stress, and||
2043|172|N|changing your diet. Consult your doctor for more details.||
2043|173|N|   Lab and/or medical tests (such as kidney function, blood||
2043|174|N|mineral levels such as potassium) should be done while you are||
2043|175|N|taking this medication. Keep all medical and lab appointments.||
2043|176|N|Consult your doctor for more details.||
2043|177|N|   Check your blood pressure regularly while taking this||
2043|178|N|medication. Learn how to monitor your own blood pressure at home,||
2043|179|N|and share the results with your doctor.||
2043|180|B|||
2043|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2043|182|D|remember. If it is near the time of the next dose, skip the||
2043|183|D|missed dose. Take your next dose at the regular time. Do not||
2043|184|D|double the dose to catch up.||
2043|185|B|||
2043|186|R|STORAGE:  Store at room temperature away from light. Do not||
2043|187|R|freeze. After the bottle is opened, refer to the manufacturer's||
2043|188|R|instructions about when to discard this medication. Keep all||
2043|189|R|medications away from children and pets.||
2043|190|R|   Do not flush medications down the toilet or pour them into a||
2043|191|R|drain unless instructed to do so. Properly discard this product||
2043|192|R|when it is expired or no longer needed. Consult your pharmacist||
2043|193|R|or local waste disposal company.||
2043|194|B|||
2043|195|A|Information last revised October 2024.||
2043|196|A|Copyright(c) 2025 First Databank, Inc.||
2043|197|B|||
2044|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2044|002|Z|does NOT have all possible information about this product. This||
2044|003|Z|information does not assure that this product is safe, effective,||
2044|004|Z|or appropriate for you. This information is not individual||
2044|005|Z|medical advice and does not substitute for the advice of your||
2044|006|Z|health care professional. Always ask your health care||
2044|007|Z|professional for complete information about this product and your||
2044|008|Z|specific health needs.||
2044|009|B|||
2044|010|T|HALOBETASOL/TAZAROTENE - TOPICAL||
2044|011|F|(HAL-oh-BAY-ta-sol/taz-AR-oh-teen)||
2044|012|B|||
2044|013|C|COMMON BRAND NAME(S): Duobrii||
2044|014|B|||
2044|015|U|USES:  This medication is a combination product used to treat a||
2044|016|U|certain skin condition (psoriasis). It contains 2 ingredients:||
2044|017|U|halobetasol and tazarotene. Halobetasol is a very strong||
2044|018|U|(super-high potency) corticosteroid. It helps reduce the itching,||
2044|019|U|redness, scaling, and swelling that can occur with this||
2044|020|U|condition. Tazarotene is a retinoid product (related to vitamin||
2044|021|U|A) that works by affecting the growth of skin cells.||
2044|022|B|||
2044|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2044|024|H|from your pharmacist before you start using||
2044|025|H|halobetasol/tazarotene and each time you get a refill. If you||
2044|026|H|have any questions, ask your doctor or pharmacist.||
2044|027|H|   Use this medication only on the affected skin. Do not apply to||
2044|028|H|normal skin areas or broken skin (such as ulcers, sores, wounds).||
2044|029|H|Do not use it on the face, groin, or underarms unless your doctor||
2044|030|H|tells you to.||
2044|031|H|   If you shower or bathe before applying this medication, make||
2044|032|H|sure your skin has dried before applying it. Apply a thin film of||
2044|033|H|medication to the affected areas and gently rub in as directed by||
2044|034|H|your doctor, usually once daily. Do not cover, bandage, or wrap||
2044|035|H|the area unless directed to do so by your doctor.||
2044|036|H|   After applying the medication, wash your hands unless you are||
2044|037|H|using this medication to treat the hands. If applying this||
2044|038|H|medication near the eyes, avoid getting it in the eyes as this||
2044|039|H|may worsen or cause glaucoma. Also avoid getting this medication||
2044|040|H|in the nose or mouth.||
2044|041|H|   Use this medication only for the condition it was prescribed||
2044|042|H|for. Do not apply more than directed, or use it more often or for||
2044|043|H|longer than prescribed . Once your condition is better, stop||
2044|044|H|using this medication. If directed by your doctor, you may then||
2044|045|H|use this medication off and on when needed.||
2044|046|H|   Since this drug is absorbed through the skin and may harm an||
2044|047|H|unborn baby, women who are pregnant or who may become pregnant||
2044|048|H|should not handle this medication.||
2044|049|H|   Tell your doctor if your condition does not get better or if||
2044|050|H|it gets worse.||
2044|051|B|||
2044|052|S|SIDE EFFECTS:  Irritation, burning, stinging, itching, dryness,||
2044|053|S|peeling, redness, or pain at the application site may occur. If||
2044|054|S|any of these effects last or get worse, tell your doctor or||
2044|055|S|pharmacist promptly. Your doctor may tell you to temporarily stop||
2044|056|S|using this medication, or to use it less often.||
2044|057|S|   Remember that this medication has been prescribed because your||
2044|058|S|doctor has judged that the benefit to you is greater than the||
2044|059|S|risk of side effects. Many people using this medication do not||
2044|060|S|have serious side effects.||
2044|061|S|   Tell your doctor right away if you have any serious side||
2044|062|S|effects, including: stretch marks, skin thinning/discoloration,||
2044|063|S|acne, excessive hair growth, small red bumps on the skin||
2044|064|S|(folliculitis).||
2044|065|S|   Skin infections can become worse when using this medication.||
2044|066|S|Tell your doctor promptly if redness, swelling or irritation does||
2044|067|S|not get better.||
2044|068|S|   Rarely, it is possible this medication will be absorbed from||
2044|069|S|the skin into the bloodstream. This can lead to side effects of||
2044|070|S|too much corticosteroid. These side effects are more likely in||
2044|071|S|children, and in people who use this medication for a long time||
2044|072|S|or over large areas of the skin. Tell your doctor right away if||
2044|073|S|any of the following side effects occur: unusual/extreme||
2044|074|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
2044|075|S|thirst/urination, vision problems.||
2044|076|S|   A very serious allergic reaction to this drug is rare.||
2044|077|S|However, get medical help right away if you notice any symptoms||
2044|078|S|of a serious allergic reaction, including: rash, itching/swelling||
2044|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2044|080|S|breathing.||
2044|081|S|   This is not a complete list of possible side effects. If you||
2044|082|S|notice other effects not listed above, contact your doctor or||
2044|083|S|pharmacist.||
2044|084|S|   In the US -||
2044|085|S|   Call your doctor for medical advice about side effects. You||
2044|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2044|087|S|www.fda.gov/medwatch.||
2044|088|S|   In Canada - Call your doctor for medical advice about side||
2044|089|S|effects. You may report side effects to Health Canada at||
2044|090|S|1-866-234-2345.||
2044|091|B|||
2044|092|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2044|093|P|pharmacist if you are allergic to halobetasol or tazarotene; or||
2044|094|P|to other corticosteroids (such as hydrocortisone, prednisone); or||
2044|095|P|to other vitamin A-related drugs (other retinoids such as||
2044|096|P|isotretinoin); or if you have any other allergies. This product||
2044|097|P|may contain inactive ingredients, which can cause allergic||
2044|098|P|reactions or other problems. Talk to your pharmacist for more||
2044|099|P|details.||
2044|100|P|   Before using this medication, tell your doctor or pharmacist||
2044|101|P|your medical history, especially of: other skin conditions (such||
2044|102|P|as rosacea, eczema, sunburn, sun sensitivity).||
2044|103|P|   This medication may make you more sensitive to the sun. Limit||
2044|104|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2044|105|P|sunscreen daily and wear protective clothing when outdoors. Tell||
2044|106|P|your doctor right away if you get sunburned or have skin||
2044|107|P|blisters/redness. Wait until your skin has completely recovered||
2044|108|P|from a sunburn before using this medication. Weather extremes||
2044|109|P|such as wind or cold may also be irritating to the skin.||
2044|110|P|   Avoid electrolysis, waxing, and chemical depilatories for hair||
2044|111|P|removal on the treated areas while using this product.||
2044|112|P|   Do not use if there is an infection or sore present in the||
2044|113|P|area to be treated.||
2044|114|P|   Rarely, using corticosteroid medications for a long time or||
2044|115|P|over large areas of skin can make it more difficult for your body||
2044|116|P|to respond to physical stress. Before having surgery or emergency||
2044|117|P|treatment, or if you get a serious illness/injury, tell your||
2044|118|P|doctor or dentist that you are using this medication or have used||
2044|119|P|this medication within the past few months.||
2044|120|P|   Though it is unlikely, this medication may temporarily slow||
2044|121|P|down a child's growth if used for a long time. See the doctor||
2044|122|P|regularly so your child's height can be checked.||
2044|123|P|   This medication must not be used during pregnancy. It may harm||
2044|124|P|an unborn baby. Discuss the use of reliable forms of birth||
2044|125|P|control (such as condoms, birth control pills) with your doctor.||
2044|126|P|If you become pregnant or think you may be pregnant, tell your||
2044|127|P|doctor right away. Before starting this medication, women who||
2044|128|P|could become pregnant should have a negative pregnancy test||
2044|129|P|result within the last 2 weeks. This medication should be started||
2044|130|P|during a normal menstrual period.||
2044|131|P|   Since this drug is absorbed through the skin and may harm an||
2044|132|P|unborn baby, women who are pregnant or who may become pregnant||
2044|133|P|should not handle this medication.||
2044|134|P|   It is unknown if this drug passes into breast milk. Consult||
2044|135|P|your doctor before breastfeeding.||
2044|136|B|||
2044|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2044|138|I|medications work or increase your risk for serious side effects.||
2044|139|I|This document does not contain all possible drug interactions.||
2044|140|I|Keep a list of all the products you use (including||
2044|141|I|prescription/nonprescription drugs and herbal products) and share||
2044|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
2044|143|I|the dosage of any medicines without your doctor's approval.||
2044|144|I|   Some products that may interact with this drug are: other||
2044|145|I|vitamin A products, hair perming solutions, other skin products||
2044|146|I|with strong drying effects, skin products containing||
2044|147|I|alcohol/lime/spice (including shaving lotions, perfume,||
2044|148|I|astringents such as calamine lotion), soaps/shampoos/cleansers||
2044|149|I|that are medicated/abrasive.||
2044|150|B|||
2044|151|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2044|152|O|has overdosed and has serious symptoms such as passing out or||
2044|153|O|trouble breathing, call 911. Otherwise, call a poison control||
2044|154|O|center right away. US residents can call 1-800-222-1222. Canada||
2044|155|O|residents can call 1-844-764-7669.||
2044|156|B|||
2044|157|N|NOTES:  Do not share this medication with others.||
2044|158|N|   This medication has been prescribed for your current condition||
2044|159|N|only. Do not use it later for other skin problems unless your||
2044|160|N|doctor tells you to. A different medication may be necessary in||
2044|161|N|those cases.||
2044|162|N|   Lab and/or medical tests (such as adrenal gland function) may||
2044|163|N|be done while you are using this medication, especially if you||
2044|164|N|use this drug for a long time or apply it over large areas of the||
2044|165|N|body. Keep all medical and lab appointments.||
2044|166|B|||
2044|167|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2044|168|D|If it is near the time of the next dose, skip the missed dose.||
2044|169|D|Use your next dose at the regular time. Do not double the dose to||
2044|170|D|catch up.||
2044|171|B|||
2044|172|R|STORAGE:  Store at room temperature. Protect from freezing. Keep||
2044|173|R|all medications away from children and pets.||
2044|174|R|   Do not flush medications down the toilet or pour them into a||
2044|175|R|drain unless instructed to do so. Properly discard this product||
2044|176|R|when it is expired or no longer needed. Consult your pharmacist||
2044|177|R|or local waste disposal company.||
2044|178|B|||
2044|179|A|Information last revised May 2024.||
2044|180|A|Copyright(c) 2025 First Databank, Inc.||
2044|181|B|||
2045|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2045|002|Z|does NOT have all possible information about this product. This||
2045|003|Z|information does not assure that this product is safe, effective,||
2045|004|Z|or appropriate for you. This information is not individual||
2045|005|Z|medical advice and does not substitute for the advice of your||
2045|006|Z|health care professional. Always ask your health care||
2045|007|Z|professional for complete information about this product and your||
2045|008|Z|specific health needs.||
2045|009|B|||
2045|010|T|METHYLPHENIDATE EXTENDED-RELEASE CAPSULE (EVENING) - ORAL||
2045|011|F|(METH-il-FEN-i-date)||
2045|012|B|||
2045|013|C|COMMON BRAND NAME(S): Jornay PM||
2045|014|B|||
2045|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
2045|016|W|serious (possibly fatal) heart and blood pressure problems.||
2045|017|W|   This medication can be habit-forming and should be used||
2045|018|W|cautiously by people who have mental/mood disorders or a||
2045|019|W|substance use disorder (such as overuse of or addiction to||
2045|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
2045|021|W|you have a personal or family history of a substance use||
2045|022|W|disorder. Do not increase your dose, use it more often, or use it||
2045|023|W|for a longer time or in a different way than prescribed. Doing so||
2045|024|W|may result in a decrease in the effect of this drug, drug||
2045|025|W|dependence, or abnormal thoughts/behavior.||
2045|026|W|   Your doctor may monitor you for a while after the medication||
2045|027|W|is stopped, especially if you have taken this drug for a long||
2045|028|W|time or in high doses. (See also How to Use section.)||
2045|029|B|||
2045|030|U|USES:  This medication is used to treat attention deficit||
2045|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
2045|032|U|of certain natural substances in the brain. Methylphenidate||
2045|033|U|belongs to a class of drugs known as stimulants. It can help||
2045|034|U|increase your ability to pay attention, stay focused on an||
2045|035|U|activity, and control behavior problems. It may also help you to||
2045|036|U|organize your tasks and improve listening skills.||
2045|037|B|||
2045|038|V|OTHER USES:  This section contains uses of this drug that are not||
2045|039|V|listed in the approved professional labeling for the drug but||
2045|040|V|that may be prescribed by your health care professional. Use this||
2045|041|V|drug for a condition that is listed in this section only if it||
2045|042|V|has been so prescribed by your health care professional.||
2045|043|V|   This drug may also be used for a certain sleep disorder||
2045|044|V|(narcolepsy).||
2045|045|B|||
2045|046|H|HOW TO USE:  Read the Medication Guide provided by your||
2045|047|H|pharmacist before you start taking methylphenidate and each time||
2045|048|H|you get a refill. If you have any questions, ask your doctor or||
2045|049|H|pharmacist.||
2045|050|H|   There are different brands and forms of this medication||
2045|051|H|available. They may not have the same effects and may not be||
2045|052|H|substituted for each other. Do not change brands or forms without||
2045|053|H|consulting your doctor or pharmacist.||
2045|054|H|   Take this medication by mouth as directed by your doctor,||
2045|055|H|usually once daily in the evening (between 6:30 PM and 9:30 PM).||
2045|056|H|This medication should not be taken in the morning. You may take||
2045|057|H|this medication with or without food, but it is important to||
2045|058|H|choose one way and take this medication the same way with every||
2045|059|H|dose.||
2045|060|H|   Do not break, crush, or chew this medication. Doing so can||
2045|061|H|release all of the drug at once, increasing the risk of side||
2045|062|H|effects. Swallow the capsules whole. If you have trouble||
2045|063|H|swallowing the capsule, you may open the capsule and carefully||
2045|064|H|sprinkle its contents on a spoonful of applesauce. Swallow all of||
2045|065|H|the mixture right away without chewing it. Do not prepare the||
2045|066|H|mixture ahead of time.||
2045|067|H|   Do not drink alcoholic beverages while you are taking this||
2045|068|H|medication. Drinking alcohol may increase the amount of this||
2045|069|H|medication in your body, which may cause serious side effects.||
2045|070|H|   Take this medication regularly to get the most benefit from||
2045|071|H|it. To help you remember, take it at the same time each day in||
2045|072|H|the evening.||
2045|073|H|   The dosage is based on your medical condition and response to||
2045|074|H|treatment. Your doctor may direct you to gradually increase or||
2045|075|H|decrease your dose. Also, if you have used it for a long time, do||
2045|076|H|not suddenly stop using this drug without consulting your doctor.||
2045|077|H|   If you suddenly stop using this medication, you may have||
2045|078|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
2045|079|H|other mental/mood changes). To help prevent withdrawal, your||
2045|080|H|doctor may lower your dose slowly. Withdrawal is more likely if||
2045|081|H|you have used methylphenidate for a long time or in high doses.||
2045|082|H|Tell your doctor or pharmacist right away if you have withdrawal.||
2045|083|H|   When this medication is used for a long time, it may not work||
2045|084|H|as well. Talk with your doctor if this medication stops working||
2045|085|H|well.||
2045|086|H|   Though it helps many people, this medication may sometimes||
2045|087|H|cause addiction. This risk may be higher if you have a substance||
2045|088|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2045|089|H|Take this medication exactly as prescribed to lower the risk of||
2045|090|H|addiction. Ask your doctor or pharmacist for more details.||
2045|091|H|   Tell your doctor if your condition does not get better or if||
2045|092|H|it gets worse.||
2045|093|B|||
2045|094|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
2045|095|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
2045|096|S|If any of these effects last or get worse, tell your doctor or||
2045|097|S|pharmacist promptly.||
2045|098|S|   Remember that this medication has been prescribed because your||
2045|099|S|doctor has judged that the benefit to you is greater than the||
2045|100|S|risk of side effects. Many people using this medication do not||
2045|101|S|have serious side effects.||
2045|102|S|   This medication may raise your blood pressure. Check your||
2045|103|S|blood pressure regularly and tell your doctor if the results are||
2045|104|S|high.||
2045|105|S|   Tell your doctor right away if you have any serious side||
2045|106|S|effects, including: signs of blood flow problems in the fingers||
2045|107|S|or toes (such as coldness, numbness, pain, or skin color||
2045|108|S|changes), unusual wounds on the fingers or toes,||
2045|109|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
2045|110|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
2045|111|S|thoughts of suicide), uncontrolled muscle movements (such as||
2045|112|S|twitching, shaking), sudden outbursts of words/sounds that are||
2045|113|S|hard to control, vision changes (such as blurred vision).||
2045|114|S|   Get medical help right away if you have any very serious side||
2045|115|S|effects, including: fainting, seizure, symptoms of a heart attack||
2045|116|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
2045|117|S|sweating), symptoms of a stroke (such as weakness on one side of||
2045|118|S|the body, trouble speaking, sudden vision changes, confusion).||
2045|119|S|   Rarely, males (including young boys and teens) may have a||
2045|120|S|painful or prolonged erection lasting 4 or more hours while using||
2045|121|S|this medication. If a painful or prolonged erection occurs, stop||
2045|122|S|using this drug and get medical help right away, or permanent||
2045|123|S|problems could occur. Ask your doctor or pharmacist for more||
2045|124|S|details.||
2045|125|S|   A very serious allergic reaction to this drug is rare.||
2045|126|S|However, get medical help right away if you notice any symptoms||
2045|127|S|of a serious allergic reaction, including: rash, itching/swelling||
2045|128|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2045|129|S|breathing.||
2045|130|S|   This is not a complete list of possible side effects. If you||
2045|131|S|notice other effects not listed above, contact your doctor or||
2045|132|S|pharmacist.||
2045|133|S|   In the US -||
2045|134|S|   Call your doctor for medical advice about side effects. You||
2045|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2045|136|S|www.fda.gov/medwatch.||
2045|137|S|   In Canada - Call your doctor for medical advice about side||
2045|138|S|effects. You may report side effects to Health Canada at||
2045|139|S|1-866-234-2345.||
2045|140|B|||
2045|141|P|PRECAUTIONS:  See also Warning section.||
2045|142|P|   Before taking methylphenidate, tell your doctor or pharmacist||
2045|143|P|if you are allergic to it; or to dexmethylphenidate; or if you||
2045|144|P|have any other allergies. This product may contain inactive||
2045|145|P|ingredients, which can cause allergic reactions or other||
2045|146|P|problems. Talk to your pharmacist for more details.||
2045|147|P|   Before using this medication, tell your doctor or pharmacist||
2045|148|P|your medical history, especially of: high blood pressure, blood||
2045|149|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
2045|150|P|problems (such as irregular heartbeat, heart failure, previous||
2045|151|P|heart attack, problems with heart structure), family history of||
2045|152|P|heart problems (such as sudden cardiac death, irregular||
2045|153|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
2045|154|P|agitation), personal/family history of mental/mood disorders||
2045|155|P|(such as bipolar disorder, depression, psychosis, suicidal||
2045|156|P|thoughts), personal/family history of uncontrolled muscle||
2045|157|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
2045|158|P|(hyperthyroidism), seizure disorder, throat/stomach/intestinal||
2045|159|P|problems (such as narrowing/blockage).||
2045|160|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2045|161|P|can make you more dizzy. Do not drive, use machinery, or do||
2045|162|P|anything that needs alertness until you can do it safely. Avoid||
2045|163|P|alcoholic beverages. Talk to your doctor if you are using||
2045|164|P|marijuana (cannabis).||
2045|165|P|   Before having surgery, tell your doctor or dentist about all||
2045|166|P|the products you use (including prescription drugs,||
2045|167|P|nonprescription drugs, and herbal products).||
2045|168|P|   Children (especially those younger than 6) may be more||
2045|169|P|sensitive to the side effects of this drug, especially weight||
2045|170|P|loss. If used for a long time, this drug may affect a child's||
2045|171|P|growth rate, weight, and final adult height. To reduce the risk,||
2045|172|P|the doctor may recommend briefly stopping the medication from||
2045|173|P|time to time. Check the child's weight and height regularly, and||
2045|174|P|consult your doctor or pharmacist for more details.||
2045|175|P|   Older adults may be more sensitive to the side effects of this||
2045|176|P|drug, especially trouble sleeping, weight loss, or chest pain.||
2045|177|P|   During pregnancy, methylphenidate should be used only when||
2045|178|P|clearly needed. Discuss the risks and benefits with your doctor.||
2045|179|P|   This medication passes into breast milk. Consult your doctor||
2045|180|P|before breastfeeding.||
2045|181|B|||
2045|182|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2045|183|I|medications work or increase your risk for serious side effects.||
2045|184|I|This document does not contain all possible drug interactions.||
2045|185|I|Keep a list of all the products you use (including||
2045|186|I|prescription/nonprescription drugs and herbal products) and share||
2045|187|I|it with your doctor and pharmacist. Do not start, stop, or change||
2045|188|I|the dosage of any medicines without your doctor's approval.||
2045|189|I|   Taking MAO inhibitors with this medication may cause a serious||
2045|190|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2045|191|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2045|192|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2045|193|I|selegiline, tranylcypromine) during treatment with this||
2045|194|I|medication. Most MAO inhibitors should also not be taken for two||
2045|195|I|weeks before treatment with this medication. Ask your doctor when||
2045|196|I|to start or stop taking this medication.||
2045|197|I|   Avoid alcohol when using this medication because it may cause||
2045|198|I|the medication to be released too quickly and increase the risk||
2045|199|I|of side effects.||
2045|200|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
2045|201|I|use medications containing dexmethylphenidate while using||
2045|202|I|methylphenidate.||
2045|203|I|   This medication may interfere with certain medical/lab tests||
2045|204|I|(including brain scan for Parkinson's disease), possibly causing||
2045|205|I|false test results. Make sure lab personnel and all your doctors||
2045|206|I|know you use this drug.||
2045|207|B|||
2045|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2045|209|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2045|210|O|poison control center right away. US residents can call||
2045|211|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2045|212|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
2045|213|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
2045|214|O|loss of consciousness.||
2045|215|B|||
2045|216|N|NOTES:  Do not share this medication with others. Sharing it is||
2045|217|N|against the law.||
2045|218|N|   Lab and/or medical tests (such as blood pressure, complete||
2045|219|N|blood count, height/weight monitoring in children) may be done||
2045|220|N|while you are taking this medication. Keep all medical and lab||
2045|221|N|appointments.||
2045|222|B|||
2045|223|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2045|224|D|remember. If you don't remember until the next morning, skip the||
2045|225|D|missed dose. Take your next dose at the regular time. Do not||
2045|226|D|double the dose to catch up.||
2045|227|B|||
2045|228|R|STORAGE:  Store this medication at room temperature away from||
2045|229|R|light and moisture. Do not store in the bathroom. Keep all||
2045|230|R|medications away from children and pets.||
2045|231|R|   Do not flush medications down the toilet or pour them into a||
2045|232|R|drain unless instructed to do so. Properly discard this product||
2045|233|R|when it is expired or no longer needed. Consult your pharmacist||
2045|234|R|or local waste disposal company.||
2045|235|B|||
2045|236|A|Information last revised July 2025.||
2045|237|A|Copyright(c) 2025 First Databank, Inc.||
2045|238|B|||
2047|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2047|002|Z|does NOT have all possible information about this product. This||
2047|003|Z|information does not assure that this product is safe, effective,||
2047|004|Z|or appropriate for you. This information is not individual||
2047|005|Z|medical advice and does not substitute for the advice of your||
2047|006|Z|health care professional. Always ask your health care||
2047|007|Z|professional for complete information about this product and your||
2047|008|Z|specific health needs.||
2047|009|B|||
2047|010|T|MIRTAZAPINE DISINTEGRATING TABLET - ORAL||
2047|011|F|(mer-TAZ-uh-peen)||
2047|012|B|||
2047|013|C|COMMON BRAND NAME(S): Remeron Soltab||
2047|014|B|||
2047|015|W|WARNING:  Antidepressant medications are used to treat a variety||
2047|016|W|of conditions, including depression and other mental/mood||
2047|017|W|disorders. These medications can help prevent suicidal||
2047|018|W|thoughts/attempts and provide other important benefits. However,||
2047|019|W|studies have shown that a small number of people (especially||
2047|020|W|people younger than 25) who take antidepressants for any||
2047|021|W|condition may experience worsening depression, other mental/mood||
2047|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
2047|023|W|talk with the doctor about the risks and benefits of||
2047|024|W|antidepressant medication (especially for people younger than||
2047|025|W|25), even if treatment is not for a mental/mood condition.||
2047|026|W|   Tell the doctor right away if you notice worsening||
2047|027|W|depression/other psychiatric conditions, unusual behavior changes||
2047|028|W|(including possible suicidal thoughts/attempts), or other||
2047|029|W|mental/mood changes (including new/worsening anxiety, panic||
2047|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2047|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
2047|032|W|especially watchful for these symptoms when a new antidepressant||
2047|033|W|is started or when the dose is changed.||
2047|034|B|||
2047|035|U|USES:  This medication is used to treat depression. Mirtazapine||
2047|036|U|works by helping to restore the balance of certain natural||
2047|037|U|substances in the brain.||
2047|038|B|||
2047|039|H|HOW TO USE:  Read the Medication Guide provided by your||
2047|040|H|pharmacist before you start using mirtazapine and each time you||
2047|041|H|get a refill. If you have any questions, ask your doctor or||
2047|042|H|pharmacist.||
2047|043|H|   Take this medication by mouth with or without food as directed||
2047|044|H|by your doctor, usually once daily at bedtime. The dosage is||
2047|045|H|based on your medical condition and response to treatment.||
2047|046|H|   With clean and dry hands, open the blister pack and place the||
2047|047|H|tablet on your tongue. The tablet will quickly dissolve and can||
2047|048|H|be swallowed with your saliva. Taking this medication with water||
2047|049|H|or liquid is not needed.||
2047|050|H|   Do not break, chew, or crush the tablets. Do not remove any||
2047|051|H|tablets from the blister pack until you are ready to take your||
2047|052|H|dose. Doing so could make it work less well.||
2047|053|H|   Use this medication regularly in order to get the most benefit||
2047|054|H|from it. To help you remember, take it at the same time each day.||
2047|055|H|It may take 1 to 4 weeks to notice improvement in your symptoms.||
2047|056|H|Do not increase your dose or take it more often than prescribed.||
2047|057|H|   Keep taking this medication even if you feel well. Do not stop||
2047|058|H|taking this medication without consulting your doctor. Some||
2047|059|H|conditions may become worse when you suddenly stop this drug.||
2047|060|H|Your dose may need to be gradually decreased.||
2047|061|H|   Tell your doctor if your condition does not get better or if||
2047|062|H|it gets worse.||
2047|063|B|||
2047|064|S|SIDE EFFECTS:  See also the Warning section.||
2047|065|S|   Dizziness, drowsiness, lightheadedness, increased appetite,||
2047|066|S|weight gain, dry mouth, or constipation may occur. If any of||
2047|067|S|these effects last or get worse, tell your doctor or pharmacist||
2047|068|S|promptly.||
2047|069|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
2047|070|S|chips, chew (sugarless) gum, drink water or use a saliva||
2047|071|S|substitute.||
2047|072|S|   To reduce the risk of dizziness and lightheadedness, get up||
2047|073|S|slowly when rising from a sitting or lying position.||
2047|074|S|   Remember that this medication has been prescribed because your||
2047|075|S|doctor has judged that the benefit to you is greater than the||
2047|076|S|risk of side effects. Many people using this medication do not||
2047|077|S|have serious side effects.||
2047|078|S|   Tell your doctor right away if you have any serious side||
2047|079|S|effects, including: swelling of the hands/feet, shaking (tremor),||
2047|080|S|confusion.||
2047|081|S|   Get medical help right away if you have any very serious side||
2047|082|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2047|083|S|fainting, eye pain/swelling/redness, widened pupils, vision||
2047|084|S|changes (such as seeing rainbows around lights at night, blurred||
2047|085|S|vision).||
2047|086|S|   This medication may increase serotonin and rarely cause a very||
2047|087|S|serious condition called serotonin syndrome/toxicity. The risk||
2047|088|S|increases if you are also taking other drugs that increase||
2047|089|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2047|090|S|take (see Drug Interactions section). Get medical help right away||
2047|091|S|if you develop some of the following symptoms: fast heartbeat,||
2047|092|S|hallucinations, loss of coordination, severe dizziness, severe||
2047|093|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2047|094|S|unusual agitation/restlessness.||
2047|095|S|   A very serious allergic reaction to this drug is rare.||
2047|096|S|However, get medical help right away if you notice any symptoms||
2047|097|S|of a serious allergic reaction, including: fever, swollen lymph||
2047|098|S|nodes, rash, itching/swelling (especially of the||
2047|099|S|face/tongue/throat), severe dizziness, trouble breathing.||
2047|100|S|   This is not a complete list of possible side effects. If you||
2047|101|S|notice other effects not listed above, contact your doctor or||
2047|102|S|pharmacist.||
2047|103|S|   In the US -||
2047|104|S|   Call your doctor for medical advice about side effects. You||
2047|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2047|106|S|www.fda.gov/medwatch.||
2047|107|S|   In Canada - Call your doctor for medical advice about side||
2047|108|S|effects. You may report side effects to Health Canada at||
2047|109|S|1-866-234-2345.||
2047|110|B|||
2047|111|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2047|112|P|pharmacist if you are allergic to it, or if you have any other||
2047|113|P|allergies. This product may contain inactive ingredients, which||
2047|114|P|can cause allergic reactions or other problems. Talk to your||
2047|115|P|pharmacist for more details.||
2047|116|P|   Before using this medication, tell your doctor or pharmacist||
2047|117|P|your medical history, especially of: history or family history of||
2047|118|P|psychiatric disorders (such as bipolar/manic-depressive||
2047|119|P|disorder), history or family history of suicide attempts, liver||
2047|120|P|disease, kidney disease, seizures, high blood cholesterol or||
2047|121|P|triglyceride levels, heart disease (such as recent heart attack,||
2047|122|P|angina), stroke, severe loss of body fluids (dehydration), low||
2047|123|P|blood pressure, personal or family history of glaucoma||
2047|124|P|(angle-closure type).||
2047|125|P|   Mirtazapine may cause a condition that affects the heart||
2047|126|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2047|127|P|serious (rarely fatal) fast/irregular heartbeat and other||
2047|128|P|symptoms (such as severe dizziness, fainting) that need medical||
2047|129|P|attention right away.||
2047|130|P|   The risk of QT prolongation may be increased if you have||
2047|131|P|certain medical conditions or are taking other drugs that may||
2047|132|P|cause QT prolongation. Before using mirtazapine, tell your doctor||
2047|133|P|or pharmacist of all the drugs you take and if you have any of||
2047|134|P|the following conditions: certain heart problems (heart failure,||
2047|135|P|slow heartbeat, QT prolongation in the EKG), family history of||
2047|136|P|certain heart problems (QT prolongation in the EKG, sudden||
2047|137|P|cardiac death).||
2047|138|P|   Low levels of potassium or magnesium in the blood may also||
2047|139|P|increase your risk of QT prolongation. This risk may increase if||
2047|140|P|you use certain drugs (such as diuretics/"water pills") or if you||
2047|141|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2047|142|P|Talk to your doctor about using mirtazapine safely.||
2047|143|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2047|144|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2047|145|P|machinery, or do anything that needs alertness until you can do||
2047|146|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2047|147|P|are using marijuana (cannabis).||
2047|148|P|   This medicine may contain aspartame. If you have||
2047|149|P|phenylketonuria (PKU) or any other condition where you must||
2047|150|P|restrict your intake of aspartame (or phenylalanine), consult||
2047|151|P|your doctor or pharmacist regarding the safe use of this||
2047|152|P|medicine.||
2047|153|P|   Older adults may be more sensitive to the side effects of this||
2047|154|P|drug, especially drowsiness and QT prolongation (see above).||
2047|155|P|   During pregnancy, this medication should be used only when||
2047|156|P|clearly needed. If this medication is used during the last 3||
2047|157|P|months of pregnancy, rarely your newborn may develop symptoms||
2047|158|P|including feeding or breathing difficulties, seizures, muscle||
2047|159|P|stiffness, jitteriness or constant crying. Report any such||
2047|160|P|symptoms to your doctor promptly. However, since untreated||
2047|161|P|mental/mood disorders (such as depression) can be a serious||
2047|162|P|condition, do not stop taking this medication unless your doctor||
2047|163|P|directs you to do so. If you are planning pregnancy, become||
2047|164|P|pregnant, or think you may be pregnant, discuss with your doctor||
2047|165|P|right away the benefits and risks of using this medication during||
2047|166|P|pregnancy.||
2047|167|P|   This drug passes into breast milk. Consult your doctor before||
2047|168|P|breastfeeding.||
2047|169|B|||
2047|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2047|171|I|medications work or increase your risk for serious side effects.||
2047|172|I|This document does not contain all possible drug interactions.||
2047|173|I|Keep a list of all the products you use (including||
2047|174|I|prescription/nonprescription drugs and herbal products) and share||
2047|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
2047|176|I|the dosage of any medicines without your doctor's approval.||
2047|177|I|   Taking MAO inhibitors with this medication may cause a serious||
2047|178|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2047|179|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2047|180|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2047|181|I|selegiline, tranylcypromine) during treatment with this||
2047|182|I|medication. Most MAO inhibitors should also not be taken for two||
2047|183|I|weeks before and after treatment with this medication. Ask your||
2047|184|I|doctor when to start or stop taking this medication.||
2047|185|I|   The risk of serotonin syndrome/toxicity increases if you are||
2047|186|I|also taking other drugs that increase serotonin. Examples include||
2047|187|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
2047|188|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2047|189|I|SNRIs such as duloxetine/venlafaxine), tryptophan, among others.||
2047|190|I|The risk of serotonin syndrome/toxicity may be more likely when||
2047|191|I|you start or increase the dose of these drugs.||
2047|192|I|   Tell your doctor or pharmacist if you are taking other||
2047|193|I|products that cause drowsiness including alcohol, marijuana||
2047|194|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
2047|195|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
2047|196|I|zolpidem), muscle relaxants (such as carisoprodol,||
2047|197|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
2047|198|I|hydrocodone).||
2047|199|I|   Check the labels on all your medicines (such as allergy or||
2047|200|I|cough-and-cold products) because they may contain ingredients||
2047|201|I|that cause drowsiness. Ask your pharmacist about using those||
2047|202|I|products safely.||
2047|203|B|||
2047|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2047|205|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2047|206|O|poison control center right away. US residents can call||
2047|207|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2047|208|O|Symptoms of overdose may include: very fast/irregular heartbeat,||
2047|209|O|severe dizziness, fainting.||
2047|210|B|||
2047|211|N|NOTES:  Do not share this medication with others.||
2047|212|N|   Lab and/or medical tests should be done while you are taking||
2047|213|N|this medication. Keep all medical and lab appointments. Consult||
2047|214|N|your doctor for more details.||
2047|215|B|||
2047|216|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2047|217|D|remember. If it is near the time of the next dose, skip the||
2047|218|D|missed dose. Take your next dose at the regular time. Do not||
2047|219|D|double the dose to catch up.||
2047|220|B|||
2047|221|R|STORAGE:  Store at room temperature away from light and moisture.||
2047|222|R|Keep the tablets in the original packaging until ready to use. Do||
2047|223|R|not store in the bathroom. Keep all medications away from||
2047|224|R|children and pets.||
2047|225|R|   Do not flush medications down the toilet or pour them into a||
2047|226|R|drain unless instructed to do so. Properly discard this product||
2047|227|R|when it is expired or no longer needed. Consult your pharmacist||
2047|228|R|or local waste disposal company.||
2047|229|B|||
2047|230|A|Information last revised July 2024.||
2047|231|A|Copyright(c) 2025 First Databank, Inc.||
2047|232|B|||
2049|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2049|002|Z|does NOT have all possible information about this product. This||
2049|003|Z|information does not assure that this product is safe, effective,||
2049|004|Z|or appropriate for you. This information is not individual||
2049|005|Z|medical advice and does not substitute for the advice of your||
2049|006|Z|health care professional. Always ask your health care||
2049|007|Z|professional for complete information about this product and your||
2049|008|Z|specific health needs.||
2049|009|B|||
2049|010|T|KETOROLAC - INJECTION||
2049|011|F|(KEE-toe-ROLE-ak)||
2049|012|B|||
2049|013|C|COMMON BRAND NAME(S): Toradol||
2049|014|B|||
2049|015|W|WARNING:  It is important that you use this medication properly||
2049|016|W|to help reduce your risk of side effects. Your doctor may adjust||
2049|017|W|your dose if you are older, have low body weight, or have kidney||
2049|018|W|problems.||
2049|019|W|   Nonsteroidal anti-inflammatory drugs (including ketorolac) may||
2049|020|W|rarely increase the risk for a heart attack or stroke. This||
2049|021|W|effect can happen at any time while using this drug but is more||
2049|022|W|likely if you use it for a long time. The risk may be greater in||
2049|023|W|older adults or if you have heart disease or increased risk for||
2049|024|W|heart disease (for example, due to smoking, family history of||
2049|025|W|heart disease, or conditions such as high blood pressure or||
2049|026|W|diabetes). Talk to your doctor about the benefits and risks of||
2049|027|W|using this drug.||
2049|028|W|   This drug may rarely cause serious (rarely fatal) bleeding||
2049|029|W|from the stomach or intestines. This effect can occur without||
2049|030|W|warning at any time while using this drug. Older adults may be at||
2049|031|W|higher risk for this effect. Do not use this medication if you||
2049|032|W|have stomach/intestinal problems (such as bleeding, ulcers).||
2049|033|W|   Stop using ketorolac and get medical help right away if you||
2049|034|W|notice any of the following rare but serious side effects:||
2049|035|W|stomach/abdominal pain that doesn't go away, bloody or||
2049|036|W|black/tarry stools, vomit that looks like coffee grounds,||
2049|037|W|chest/jaw/left arm pain, shortness of breath, unusual sweating,||
2049|038|W|weakness on one side of the body, sudden vision changes, trouble||
2049|039|W|speaking.||
2049|040|W|   Do not use this drug right before or after heart bypass||
2049|041|W|surgery (CABG) or before any surgery. It also should not be used||
2049|042|W|during labor/delivery or in people with severe kidney problems or||
2049|043|W|high risk for kidney problems. Do not use ketorolac if you are||
2049|044|W|taking high doses of aspirin or other nonsteroidal||
2049|045|W|anti-inflammatory drugs (NSAIDs). See also Drug Interactions||
2049|046|W|section.||
2049|047|B|||
2049|048|U|USES:  Ketorolac is used for the short-term treatment of moderate||
2049|049|U|to severe pain. It is usually used before or after medical||
2049|050|U|procedures or after surgery. Reducing pain helps you recover more||
2049|051|U|comfortably so that you can return to your normal daily||
2049|052|U|activities. This medication is a nonsteroidal anti-inflammatory||
2049|053|U|drug (NSAID). It works by blocking your body's production of||
2049|054|U|certain natural substances that cause inflammation. This effect||
2049|055|U|helps to decrease swelling, pain, or fever.||
2049|056|U|   Ketorolac should not be used for mild or long-term painful||
2049|057|U|conditions (such as arthritis).||
2049|058|B|||
2049|059|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2049|060|H|Patient Information Leaflet provided by your pharmacist before||
2049|061|H|you start using ketorolac. If you have any questions, ask your||
2049|062|H|doctor or pharmacist.||
2049|063|H|   This medication is given by injection into a muscle or vein as||
2049|064|H|directed by your doctor. It may be given as a one-time dose or||
2049|065|H|given on a regular schedule. If given on a regular schedule, it||
2049|066|H|is usually injected every 6 hours as needed, or as directed by||
2049|067|H|your doctor. This drug must not be injected into the spine.||
2049|068|H|   Dosage is based on your medical condition and response to||
2049|069|H|treatment. To reduce your risk of stomach bleeding and other side||
2049|070|H|effects, use this medication at the lowest effective dose for the||
2049|071|H|shortest possible time. Do not increase your dose, use it more||
2049|072|H|often, or use it for longer than 5 days. If you still have pain||
2049|073|H|after 5 days, talk with your doctor about other medications you||
2049|074|H|may use.||
2049|075|H|   If you are giving this medication to yourself at home, learn||
2049|076|H|all preparation and usage instructions from your health care||
2049|077|H|professional. Before using, check this product for particles or||
2049|078|H|discoloration. If either is present, do not use the liquid. Learn||
2049|079|H|how to store and discard medical supplies safely.||
2049|080|H|   If you have "breakthrough" pain while using this medication,||
2049|081|H|ask your doctor about other medications that you can use with||
2049|082|H|this drug. Tell your doctor if your condition gets worse or if||
2049|083|H|your pain is not relieved.||
2049|084|B|||
2049|085|S|SIDE EFFECTS:  See also Warning section.||
2049|086|S|   Pain at the injection site, dizziness, drowsiness, headache,||
2049|087|S|or upset stomach may occur. If any of these effects last or get||
2049|088|S|worse, tell your doctor or pharmacist promptly.||
2049|089|S|   Remember that this medication has been prescribed because your||
2049|090|S|doctor has judged that the benefit to you is greater than the||
2049|091|S|risk of side effects. Many people using this medication do not||
2049|092|S|have serious side effects.||
2049|093|S|   This medication may raise your blood pressure. Check your||
2049|094|S|blood pressure regularly and tell your doctor if the results are||
2049|095|S|high.||
2049|096|S|   Tell your doctor right away if you have any serious side||
2049|097|S|effects, including: fainting, fast/pounding heartbeat, hearing||
2049|098|S|changes (such as ringing in the ears), mental/mood changes (such||
2049|099|S|as confusion, depression), stomach pain, vision changes (such as||
2049|100|S|blurred vision), easy bruising/bleeding, signs of kidney problems||
2049|101|S|(such as change in the amount of urine), symptoms of heart||
2049|102|S|failure (such as swelling ankles/feet, unusual tiredness,||
2049|103|S|unusual/sudden weight gain).||
2049|104|S|   This drug may rarely cause serious (possibly fatal) liver||
2049|105|S|disease. Get medical help right away if you have any symptoms of||
2049|106|S|liver damage, including: nausea/vomiting that doesn't stop, dark||
2049|107|S|urine, stomach/abdominal pain, yellowing eyes/skin.||
2049|108|S|   A very serious allergic reaction to this drug is rare.||
2049|109|S|However, get medical help right away if you notice any symptoms||
2049|110|S|of a serious allergic reaction, including: fever, swollen lymph||
2049|111|S|nodes, rash, itching/swelling (especially of the||
2049|112|S|face/tongue/throat), severe dizziness, trouble breathing.||
2049|113|S|   This is not a complete list of possible side effects. If you||
2049|114|S|notice other effects not listed above, contact your doctor or||
2049|115|S|pharmacist.||
2049|116|S|   In the US -||
2049|117|S|   Call your doctor for medical advice about side effects. You||
2049|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2049|119|S|www.fda.gov/medwatch.||
2049|120|S|   In Canada - Call your doctor for medical advice about side||
2049|121|S|effects. You may report side effects to Health Canada at||
2049|122|S|1-866-234-2345.||
2049|123|B|||
2049|124|P|PRECAUTIONS:  Before using ketorolac, tell your doctor or||
2049|125|P|pharmacist if you are allergic to it; or to aspirin or other||
2049|126|P|nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen,||
2049|127|P|naproxen, celecoxib); or if you have any other allergies. This||
2049|128|P|product may contain inactive ingredients, which can cause||
2049|129|P|allergic reactions or other problems. Talk to your pharmacist for||
2049|130|P|more details.||
2049|131|P|   Before using this medication, tell your doctor or pharmacist||
2049|132|P|your medical history, especially of: asthma (including a history||
2049|133|P|of worsening breathing after taking aspirin or other NSAIDs),||
2049|134|P|bleeding or clotting problems, blood disorders (such as anemia),||
2049|135|P|heart disease (such as previous heart attack), high blood||
2049|136|P|pressure, liver disease, growths in the nose (nasal polyps),||
2049|137|P|throat/stomach/intestinal problems (such as bleeding, heartburn,||
2049|138|P|ulcers), stroke, swelling of the ankles/feet/hands.||
2049|139|P|   Kidney problems can sometimes occur with the use of NSAID||
2049|140|P|medications, including ketorolac. Problems are more likely to||
2049|141|P|occur if you are dehydrated, have heart failure or kidney||
2049|142|P|disease, are an older adult, or if you take certain medications||
2049|143|P|(see also Drug Interactions section). Drink plenty of fluids as||
2049|144|P|directed by your doctor to prevent dehydration and tell your||
2049|145|P|doctor right away if you have a change in the amount of urine.||
2049|146|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2049|147|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2049|148|P|machinery, or do anything that needs alertness until you can do||
2049|149|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2049|150|P|are using marijuana (cannabis).||
2049|151|P|   This medicine may cause stomach/intestinal bleeding. Daily use||
2049|152|P|of alcohol and tobacco, especially when combined with this||
2049|153|P|medicine, may increase your risk for stomach bleeding. Limit||
2049|154|P|alcohol and stop smoking. Consult your doctor or pharmacist for||
2049|155|P|more information.||
2049|156|P|   This medication may make you more sensitive to the sun. Limit||
2049|157|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2049|158|P|sunscreen and wear protective clothing when outdoors. Tell your||
2049|159|P|doctor right away if you get sunburned or have skin||
2049|160|P|blisters/redness.||
2049|161|P|   Before having surgery, tell your doctor or dentist about all||
2049|162|P|the products you use (including prescription drugs,||
2049|163|P|nonprescription drugs, and herbal products).||
2049|164|P|   Older adults may be at greater risk for stomach/intestinal||
2049|165|P|bleeding, kidney problems, heart attack, and stroke while using||
2049|166|P|this drug.||
2049|167|P|   Before using this medication, women of childbearing age should||
2049|168|P|talk with their doctor(s) about the benefits and risks. Tell your||
2049|169|P|doctor if you are pregnant or if you plan to become pregnant.||
2049|170|P|This medication may harm an unborn baby and cause problems with||
2049|171|P|normal labor/delivery. It is not recommended for use in pregnancy||
2049|172|P|from 20 weeks until delivery. If your doctor decides that you||
2049|173|P|need to use this medication between 20 and 30 weeks of pregnancy,||
2049|174|P|you should use the lowest effective dose for the shortest||
2049|175|P|possible time. You should not use this medication after 30 weeks||
2049|176|P|of pregnancy.||
2049|177|P|   This drug passes into breast milk. Consult your doctor before||
2049|178|P|breastfeeding.||
2049|179|B|||
2049|180|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2049|181|I|medications work or increase your risk for serious side effects.||
2049|182|I|This document does not contain all possible drug interactions.||
2049|183|I|Keep a list of all the products you use (including||
2049|184|I|prescription/nonprescription drugs and herbal products) and share||
2049|185|I|it with your doctor and pharmacist. Do not start, stop, or change||
2049|186|I|the dosage of any medicines without your doctor's approval.||
2049|187|I|   Some products that may interact with this drug include:||
2049|188|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
2049|189|I|angiotensin II receptor blockers (such as valsartan, losartan),||
2049|190|I|corticosteroids (such as prednisone), methotrexate, other||
2049|191|I|medications that may affect the kidneys (including cidofovir),||
2049|192|I|"water pills" (diuretics such as furosemide).||
2049|193|I|   Other medications can affect the removal of ketorolac from||
2049|194|I|your body, which may affect how ketorolac works. Examples include||
2049|195|I|cabotegravir, leflunomide, nitisinone, probenecid, teriflunomide,||
2049|196|I|vadadustat, among others.||
2049|197|I|   This medication may increase the risk of bleeding when used||
2049|198|I|with other drugs that also may cause bleeding. Examples include||
2049|199|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2049|200|I|dabigatran/enoxaparin/warfarin, among others.||
2049|201|I|   This medication can slow down the removal of other medications||
2049|202|I|from your body, which may affect how they work. Examples of||
2049|203|I|affected drugs include lithium, pemetrexed, among others.||
2049|204|I|   Check all prescription and nonprescription medicine labels||
2049|205|I|carefully since many medications contain pain relievers/fever||
2049|206|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These||
2049|207|I|drugs are similar to ketorolac and may increase your risk of side||
2049|208|I|effects if taken together. However, if your doctor has told you||
2049|209|I|to take low-dose aspirin to prevent heart attack or stroke||
2049|210|I|(usually 81-162 milligrams a day), you should keep taking the||
2049|211|I|aspirin unless your doctor tells you not to. Ask your doctor or||
2049|212|I|pharmacist for more details.||
2049|213|B|||
2049|214|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2049|215|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2049|216|O|poison control center right away. US residents can call||
2049|217|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2049|218|O|Symptoms of overdose may include: severe stomach pain, vomit that||
2049|219|O|looks like coffee grounds, extreme drowsiness, slow/shallow||
2049|220|O|breathing.||
2049|221|B|||
2049|222|N|NOTES:  Do not share this medication with others.||
2049|223|N|   Lab and/or medical tests (including blood pressure, kidney||
2049|224|N|function) may be done while you are using this medication. Keep||
2049|225|N|all medical and lab appointments. Consult your doctor for more||
2049|226|N|details.||
2049|227|N|   This medication has been prescribed for your current condition||
2049|228|N|only. Do not use it later for another condition unless your||
2049|229|N|doctor directs you to do so. A different medication may be||
2049|230|N|necessary in that case.||
2049|231|B|||
2049|232|D|MISSED DOSE:  It is important to get each dose of this medication||
2049|233|D|as scheduled. If you are using this drug on a regular schedule||
2049|234|D|(not "as needed") and you miss a dose, ask your doctor or||
2049|235|D|pharmacist right away for a new dosing schedule. Do not double||
2049|236|D|the dose to catch up.||
2049|237|B|||
2049|238|R|STORAGE:  Different brands of this medication have different||
2049|239|R|storage needs. Check the product package for instructions on how||
2049|240|R|to store your brand, or ask your pharmacist. Keep all medications||
2049|241|R|away from children and pets.||
2049|242|R|   Do not flush medications down the toilet or pour them into a||
2049|243|R|drain unless instructed to do so. Properly discard this product||
2049|244|R|when it is expired or no longer needed. Consult your pharmacist||
2049|245|R|or local waste disposal company.||
2049|246|B|||
2049|247|A|Information last revised July 2025.||
2049|248|A|Copyright(c) 2025 First Databank, Inc.||
2049|249|B|||
2050|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2050|002|Z|does NOT have all possible information about this product. This||
2050|003|Z|information does not assure that this product is safe, effective,||
2050|004|Z|or appropriate for you. This information is not individual||
2050|005|Z|medical advice and does not substitute for the advice of your||
2050|006|Z|health care professional. Always ask your health care||
2050|007|Z|professional for complete information about this product and your||
2050|008|Z|specific health needs.||
2050|009|B|||
2050|010|T|PENICILLIN V POTASSIUM - ORAL||
2050|011|F|(pen-ih-SILL-in VEE poh-TASS-ee-um)||
2050|012|B|||
2050|013|C|COMMON BRAND NAME(S): Pen-Vee K, V-Cillin K, Veetids||
2050|014|B|||
2050|015|U|USES:  Penicillin is an antibiotic used to treat and prevent a||
2050|016|U|wide variety of bacterial infections. It works by stopping the||
2050|017|U|growth of bacteria.||
2050|018|U|   This antibiotic treats and prevents only bacterial infections.||
2050|019|U|It will not work for virus infections (such as the common cold,||
2050|020|U|flu). Using any antibiotic when it is not needed can cause it to||
2050|021|U|not work for future infections.||
2050|022|B|||
2050|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
2050|024|H|doctor. This medication may be taken with or without food.||
2050|025|H|However, penicillin is best absorbed when taken on an empty||
2050|026|H|stomach (1 hour before or 2 hours after meals).||
2050|027|H|   The dosage is based on your medical condition and response to||
2050|028|H|treatment.||
2050|029|H|   For the best effect, take this antibiotic at evenly spaced||
2050|030|H|times. To help you remember, take this medication at the same||
2050|031|H|time(s) every day.||
2050|032|H|   Continue to take this medication until the full prescribed||
2050|033|H|amount is finished, even if symptoms disappear after a few days.||
2050|034|H|Stopping the medication too early may result in a return of the||
2050|035|H|infection.||
2050|036|H|   Tell your doctor if your condition lasts or gets worse.||
2050|037|B|||
2050|038|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, diarrhea, and||
2050|039|S|mouth sores may occur. If any of these effects last or get worse,||
2050|040|S|tell your doctor or pharmacist promptly.||
2050|041|S|   Although this effect is uncommon, you may develop a black,||
2050|042|S|"hairy" tongue while taking this medication. This effect is||
2050|043|S|harmless and usually goes away after treatment. Maintain good||
2050|044|S|oral hygiene, and brush your tongue with a soft toothbrush twice||
2050|045|S|a day. Consult your doctor or pharmacist for more information.||
2050|046|S|   Remember that this medication has been prescribed because your||
2050|047|S|doctor has judged that the benefit to you is greater than the||
2050|048|S|risk of side effects. Many people using this medication do not||
2050|049|S|have serious side effects.||
2050|050|S|   Tell your doctor right away if you have any serious side||
2050|051|S|effects, including: unusual tiredness, joint/muscle pain, easy||
2050|052|S|bruising/bleeding.||
2050|053|S|   This medication may rarely cause a severe intestinal condition||
2050|054|S|due to a bacteria called C. difficile. This condition may occur||
2050|055|S|during treatment or weeks to months after treatment has stopped.||
2050|056|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2050|057|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2050|058|S|stool.||
2050|059|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2050|060|S|products because they may make symptoms worse.||
2050|061|S|   Use of this medication for prolonged or repeated periods may||
2050|062|S|result in oral thrush or a new vaginal yeast infection (oral or||
2050|063|S|vaginal fungal infection). Contact your doctor if you notice||
2050|064|S|white patches in your mouth, a change in vaginal discharge or||
2050|065|S|other new symptoms.||
2050|066|S|   A very serious allergic reaction to this drug is rare.||
2050|067|S|However, get medical help right away if you notice any symptoms||
2050|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2050|069|S|(especially of the face/tongue/throat), new fever, severe||
2050|070|S|dizziness, trouble breathing.||
2050|071|S|   This is not a complete list of possible side effects. If you||
2050|072|S|notice other effects not listed above, contact your doctor or||
2050|073|S|pharmacist.||
2050|074|S|   In the US -||
2050|075|S|   Call your doctor for medical advice about side effects. You||
2050|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2050|077|S|www.fda.gov/medwatch.||
2050|078|S|   In Canada - Call your doctor for medical advice about side||
2050|079|S|effects. You may report side effects to Health Canada at||
2050|080|S|1-866-234-2345.||
2050|081|B|||
2050|082|P|PRECAUTIONS:  Before taking penicillin, tell your doctor or||
2050|083|P|pharmacist if you are allergic to it; or to other antibiotics||
2050|084|P|including penicillin-type medications (such as amoxicillin,||
2050|085|P|ampicillin) or cephalosporins (such as cephalexin, cefuroxime);||
2050|086|P|or if you have any other allergies. This product may contain||
2050|087|P|inactive ingredients, which can cause allergic reactions or other||
2050|088|P|problems. Talk to your pharmacist for more details.||
2050|089|P|   Before using this medication, tell your doctor or pharmacist||
2050|090|P|your medical history, especially of: kidney problems.||
2050|091|P|   Penicillin may cause live bacterial vaccines (such as typhoid||
2050|092|P|vaccine) to not work well. Tell your health care professional||
2050|093|P|that you are using penicillin before having any||
2050|094|P|immunizations/vaccinations.||
2050|095|P|   During pregnancy, this medication should be used only when||
2050|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
2050|097|P|   This drug passes into breast milk. Consult your doctor before||
2050|098|P|breastfeeding.||
2050|099|B|||
2050|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2050|101|I|medications work or increase your risk for serious side effects.||
2050|102|I|This document does not contain all possible drug interactions.||
2050|103|I|Keep a list of all the products you use (including||
2050|104|I|prescription/nonprescription drugs and herbal products) and share||
2050|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
2050|106|I|the dosage of any medicines without your doctor's approval.||
2050|107|I|   Some products that may interact with this drug are:||
2050|108|I|methotrexate, khat, guar gum.||
2050|109|I|   This medication may interfere with certain lab tests (such as||
2050|110|I|certain diabetic urine tests), possibly causing false test||
2050|111|I|results. Make sure lab personnel and all your doctors know you||
2050|112|I|use this drug.||
2050|113|B|||
2050|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2050|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2050|116|O|poison control center right away. US residents can call||
2050|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2050|118|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
2050|119|O|severe vomiting.||
2050|120|B|||
2050|121|N|NOTES:  Do not share this medication with others.||
2050|122|N|   This medication has been prescribed for your current condition||
2050|123|N|only. Do not use it later for another infection unless your||
2050|124|N|doctor tells you to.||
2050|125|N|   With long term treatment, lab and/or medical tests (such as||
2050|126|N|kidney function, complete blood counts) should be done while you||
2050|127|N|are taking this medication. Keep all medical and lab||
2050|128|N|appointments. Consult your doctor for more details.||
2050|129|B|||
2050|130|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2050|131|D|remember. If it is near the time of the next dose, skip the||
2050|132|D|missed dose. Take your next dose at the regular time. Do not||
2050|133|D|double the dose to catch up.||
2050|134|B|||
2050|135|R|STORAGE:  Store at room temperature away from light and moisture.||
2050|136|R|Do not store in the bathroom. Keep all medications away from||
2050|137|R|children and pets.||
2050|138|R|   Do not flush medications down the toilet or pour them into a||
2050|139|R|drain unless instructed to do so. Properly discard this product||
2050|140|R|when it is expired or no longer needed. Consult your pharmacist||
2050|141|R|or local waste disposal company.||
2050|142|B|||
2050|143|A|Information last revised May 2024.||
2050|144|A|Copyright(c) 2025 First Databank, Inc.||
2050|145|B|||
2051|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2051|002|Z|does NOT have all possible information about this product. This||
2051|003|Z|information does not assure that this product is safe, effective,||
2051|004|Z|or appropriate for you. This information is not individual||
2051|005|Z|medical advice and does not substitute for the advice of your||
2051|006|Z|health care professional. Always ask your health care||
2051|007|Z|professional for complete information about this product and your||
2051|008|Z|specific health needs.||
2051|009|B|||
2051|010|T|RIZATRIPTAN DISINTEGRATING TABLET - ORAL||
2051|011|F|(RYE-za-TRIP-tan)||
2051|012|B|||
2051|013|C|COMMON BRAND NAME(S): Maxalt MLT||
2051|014|B|||
2051|015|U|USES:  Rizatriptan is used to treat migraines. It helps to||
2051|016|U|relieve headache, pain, and other migraine symptoms (including||
2051|017|U|nausea, vomiting, sensitivity to light/sound). Prompt treatment||
2051|018|U|helps you return to your normal routine and may decrease your||
2051|019|U|need for other pain medications. Rizatriptan belongs to a class||
2051|020|U|of drugs known as triptans. It affects a certain natural||
2051|021|U|substance (serotonin) that causes narrowing of blood vessels in||
2051|022|U|the brain. It may also relieve pain by affecting certain nerves||
2051|023|U|in the brain.||
2051|024|U|   Rizatriptan does not prevent future migraines or lessen how||
2051|025|U|often you get migraine attacks.||
2051|026|B|||
2051|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2051|028|H|from your pharmacist before you start taking rizatriptan and each||
2051|029|H|time you get a refill. If you have any questions, ask your doctor||
2051|030|H|or pharmacist.||
2051|031|H|   Take this medication as directed by your doctor, at the first||
2051|032|H|sign of a migraine. Handle the tablets with dry hands. Place the||
2051|033|H|tablet on your tongue, allow it to dissolve, and swallow with||
2051|034|H|your saliva. You do not need to take this medication with water||
2051|035|H|or other liquid. It may be taken with or without food, but may||
2051|036|H|work faster when it is taken on an empty stomach.||
2051|037|H|   Do not break or crush the tablets. If you are using the||
2051|038|H|individually wrapped tablets, do not open the outer pouch until||
2051|039|H|the dose is needed. Peel the foil back and carefully remove the||
2051|040|H|tablet from the blister pack immediately before taking your dose.||
2051|041|H|If you are using the tablets from a bottle, leave the tablets in||
2051|042|H|the bottle they came in until you are ready to take a dose. Keep||
2051|043|H|the bottle tightly closed between uses.||
2051|044|H|   The dosage is based on your medical condition, response to||
2051|045|H|treatment, age, and other medications you may be taking.||
2051|046|H|Children's dosage is also based on weight. Be sure to tell your||
2051|047|H|doctor and pharmacist about all the products you use (including||
2051|048|H|prescription drugs, nonprescription drugs, and herbal products).||
2051|049|H|   If there is no improvement in your symptoms, do not take more||
2051|050|H|doses of this medication before talking to your doctor. If your||
2051|051|H|symptoms are only partly relieved, or if your headache comes||
2051|052|H|back, adults may take another dose at least 2 hours after the||
2051|053|H|first dose. Children should not take more than one dose, or 5||
2051|054|H|milligrams in a 24-hour period. For adults, the US manufacturer||
2051|055|H|recommends a maximum dose of 30 milligrams in a 24-hour period.||
2051|056|H|The Canadian manufacturer recommends a maximum dose of 20||
2051|057|H|milligrams (for adults) in a 24-hour period.||
2051|058|H|   If you have a higher risk for heart problems (see||
2051|059|H|Precautions), your doctor may perform a heart exam before you||
2051|060|H|start taking rizatriptan. He/she may also direct you to take your||
2051|061|H|first dose of this medication in the office/clinic to monitor for||
2051|062|H|serious side effects (such as chest pain). Talk to your doctor||
2051|063|H|for details.||
2051|064|H|   If you are using drugs for migraine attacks on 10 or more days||
2051|065|H|each month, the drugs may actually make your headaches worse||
2051|066|H|(medication overuse headache). Do not use medications more often||
2051|067|H|or for longer than directed. Tell your doctor if you need to use||
2051|068|H|this medication more often, or if the medication is not working||
2051|069|H|as well, or if your headaches get worse.||
2051|070|B|||
2051|071|S|SIDE EFFECTS:  Flushing, feelings of||
2051|072|S|tingling/numbness/prickling/heat, tiredness, weakness,||
2051|073|S|drowsiness, or dizziness may occur. If any of these effects last||
2051|074|S|or get worse, tell your doctor or pharmacist promptly.||
2051|075|S|   Remember that this medication has been prescribed because your||
2051|076|S|doctor has judged that the benefit to you is greater than the||
2051|077|S|risk of side effects. Many people using this medication do not||
2051|078|S|have serious side effects.||
2051|079|S|   This medication may raise your blood pressure. Check your||
2051|080|S|blood pressure regularly and tell your doctor if the results are||
2051|081|S|high.||
2051|082|S|   Tell your doctor right away if you have any serious side||
2051|083|S|effects, including: blue fingers/toes/nails, cold hands/feet,||
2051|084|S|hearing changes, mental/mood changes.||
2051|085|S|   Rizatriptan can commonly cause chest/jaw/neck tightness, pain,||
2051|086|S|or pressure that is usually not serious. However, these side||
2051|087|S|effects are like symptoms of a heart attack, which may include||
2051|088|S|chest/jaw/left arm pain, shortness of breath, or unusual||
2051|089|S|sweating. Get medical help right away if these or other serious||
2051|090|S|side effects occur, including: fast/irregular heartbeat,||
2051|091|S|fainting, severe stomach/abdominal pain, bloody diarrhea, signs||
2051|092|S|of a stroke (such as weakness on one side of the body, trouble||
2051|093|S|speaking, sudden vision changes, confusion).||
2051|094|S|   This medication may increase serotonin and rarely cause a very||
2051|095|S|serious condition called serotonin syndrome/toxicity. The risk||
2051|096|S|increases if you are also taking other drugs that increase||
2051|097|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2051|098|S|take (see Drug Interactions section). Get medical help right away||
2051|099|S|if you develop some of the following symptoms: fast heartbeat,||
2051|100|S|hallucinations, loss of coordination, severe dizziness, severe||
2051|101|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2051|102|S|unusual agitation/restlessness.||
2051|103|S|   A very serious allergic reaction to this drug is rare.||
2051|104|S|However, get medical help right away if you notice any symptoms||
2051|105|S|of a serious allergic reaction, including: rash, itching/swelling||
2051|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2051|107|S|breathing.||
2051|108|S|   This is not a complete list of possible side effects. If you||
2051|109|S|notice other effects not listed above, contact your doctor or||
2051|110|S|pharmacist.||
2051|111|S|   In the US -||
2051|112|S|   Call your doctor for medical advice about side effects. You||
2051|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2051|114|S|www.fda.gov/medwatch.||
2051|115|S|   In Canada - Call your doctor for medical advice about side||
2051|116|S|effects. You may report side effects to Health Canada at||
2051|117|S|1-866-234-2345.||
2051|118|B|||
2051|119|P|PRECAUTIONS:  Before using rizatriptan, tell your doctor or||
2051|120|P|pharmacist if you are allergic to it; or if you have any other||
2051|121|P|allergies. This product may contain inactive ingredients, which||
2051|122|P|can cause allergic reactions or other problems. Talk to your||
2051|123|P|pharmacist for more details.||
2051|124|P|   Before using this medication, tell your doctor or pharmacist||
2051|125|P|your medical history, especially of: blood circulation problems||
2051|126|P|(for example, in your legs, arms/hands, or stomach), certain||
2051|127|P|types of headaches (hemiplegic or basilar migraine), heart||
2051|128|P|problems (such as chest pain, irregular heartbeat, previous heart||
2051|129|P|attack), liver disease, seizure, stroke or "mini-stroke"||
2051|130|P|(transient ischemic attack).||
2051|131|P|   Certain conditions can increase your risk for heart problems.||
2051|132|P|Tell your doctor if you have any of these conditions, including:||
2051|133|P|high blood pressure, high cholesterol, diabetes, family history||
2051|134|P|of heart disease, overweight, smoker, postmenopausal (women), age||
2051|135|P|more than 40 years (men).||
2051|136|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2051|137|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2051|138|P|machinery, or do anything that needs alertness until you can do||
2051|139|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2051|140|P|are using marijuana (cannabis).||
2051|141|P|   This medication may contain aspartame. If you have||
2051|142|P|phenylketonuria (PKU) or any other condition that requires you to||
2051|143|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
2051|144|P|doctor or pharmacist about using this medication safely.||
2051|145|P|   Before having surgery, tell your doctor or dentist about all||
2051|146|P|the products you use (including prescription drugs,||
2051|147|P|nonprescription drugs, and herbal products).||
2051|148|P|   The risk of heart disease, liver disease, and high blood||
2051|149|P|pressure increases with age. Older adults may be more sensitive||
2051|150|P|to the side effects of this drug, especially increased blood||
2051|151|P|pressure and heart problems.||
2051|152|P|   During pregnancy, this medication should be used only when||
2051|153|P|clearly needed. Discuss the risks and benefits with your doctor.||
2051|154|P|   This medication passes into breast milk. Consult your doctor||
2051|155|P|before breastfeeding.||
2051|156|B|||
2051|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2051|158|I|medications work or increase your risk for serious side effects.||
2051|159|I|This document does not contain all possible drug interactions.||
2051|160|I|Keep a list of all the products you use (including||
2051|161|I|prescription/nonprescription drugs and herbal products) and share||
2051|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
2051|163|I|the dosage of any medicines without your doctor's approval.||
2051|164|I|   Taking MAO inhibitors with this medication may cause a serious||
2051|165|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
2051|166|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2051|167|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2051|168|I|selegiline, tranylcypromine) during treatment with this||
2051|169|I|medication. Most MAO inhibitors should also not be taken for two||
2051|170|I|weeks before treatment with this medication. Ask your doctor when||
2051|171|I|to start or stop taking this medication.||
2051|172|I|   The risk of serotonin syndrome/toxicity increases if you are||
2051|173|I|also taking other drugs that increase serotonin. Examples include||
2051|174|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
2051|175|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2051|176|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2051|177|I|serotonin syndrome/toxicity may be more likely when you start or||
2051|178|I|increase the dose of these drugs.||
2051|179|I|   If you also take any ergotamine medication (such as||
2051|180|I|dihydroergotamine) or other "triptan" drugs (such as sumatriptan,||
2051|181|I|zolmitriptan), you will need to separate your rizatriptan dose at||
2051|182|I|least 24 hours apart from your dose of these other medications to||
2051|183|I|lessen the chance of serious side effects.||
2051|184|B|||
2051|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2051|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2051|187|O|poison control center right away. US residents can call||
2051|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2051|189|B|||
2051|190|N|NOTES:  Do not share this medication with others.||
2051|191|N|   Certain foods, beverages, or food additives (such as red wine,||
2051|192|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
2051|193|N|patterns such as irregular eating/sleeping habits or stress may||
2051|194|N|bring on a migraine headache. Avoiding these "triggers" may help||
2051|195|N|lessen migraine attacks. Consult your doctor for more details.||
2051|196|N|   Lab and/or medical tests (such as blood pressure) may be done||
2051|197|N|while you are taking this medication. Keep all medical and lab||
2051|198|N|appointments. Consult your doctor for more details.||
2051|199|B|||
2051|200|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
2051|201|B|||
2051|202|R|STORAGE:  Store at room temperature away from light and moisture.||
2051|203|R|Do not store in the bathroom. Keep all medications away from||
2051|204|R|children and pets.||
2051|205|R|   Do not flush medications down the toilet or pour them into a||
2051|206|R|drain unless instructed to do so. Properly discard this product||
2051|207|R|when it is expired or no longer needed. Consult your pharmacist||
2051|208|R|or local waste disposal company.||
2051|209|B|||
2051|210|A|Information last revised March 2025.||
2051|211|A|Copyright(c) 2025 First Databank, Inc.||
2051|212|B|||
2052|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2052|002|Z|does NOT have all possible information about this product. This||
2052|003|Z|information does not assure that this product is safe, effective,||
2052|004|Z|or appropriate for you. This information is not individual||
2052|005|Z|medical advice and does not substitute for the advice of your||
2052|006|Z|health care professional. Always ask your health care||
2052|007|Z|professional for complete information about this product and your||
2052|008|Z|specific health needs.||
2052|009|B|||
2052|010|T|KETOCONAZOLE - ORAL||
2052|011|F|(kee-toe-CON-uh-zole)||
2052|012|B|||
2052|013|C|COMMON BRAND NAME(S): Nizoral||
2052|014|B|||
2052|015|W|WARNING:  Ketoconazole can cause serious (possibly fatal) side||
2052|016|W|effects and drug interactions. It should only be used when other||
2052|017|W|treatments have not worked, are not available, or cannot be taken||
2052|018|W|by you. Discuss the risks and benefits of this medication, as||
2052|019|W|well as other effective and possibly safer treatments for fungal||
2052|020|W|infections, with your doctor.||
2052|021|W|   Ketoconazole has rarely caused very serious (possibly fatal)||
2052|022|W|liver problems. Get medical help right away if you develop||
2052|023|W|symptoms of liver problems, including nausea/vomiting that||
2052|024|W|doesn't stop, stomach/abdominal pain, dark urine, yellowing||
2052|025|W|eyes/skin, loss of appetite, or light colored stools. To reduce||
2052|026|W|your risk for liver problems, your doctor should obtain liver||
2052|027|W|function tests every week while you are taking this medication.||
2052|028|W|Do not drink alcoholic beverages while taking ketoconazole||
2052|029|W|because alcohol increases the risk of serious liver problems. See||
2052|030|W|also Notes section.||
2052|031|W|   Ketoconazole must not be used with certain other medications||
2052|032|W|because a serious, possibly fatal, drug interaction may occur.||
2052|033|W|Ketoconazole interacts with drugs such as disopyramide,||
2052|034|W|dofetilide, dronedarone, methadone, pimozide, quinidine,||
2052|035|W|ranolazine, among others. These interactions may increase the||
2052|036|W|risk of a certain condition that affects the heart rhythm (QT||
2052|037|W|prolongation). QT prolongation can rarely cause serious (rarely||
2052|038|W|fatal) fast/irregular heartbeat and other symptoms (such as||
2052|039|W|severe dizziness, fainting) that need medical attention right||
2052|040|W|away. Tell your doctor and pharmacist about all the medications||
2052|041|W|and products you may be taking before you start ketoconazole||
2052|042|W|treatment. See also Precautions section.||
2052|043|B|||
2052|044|U|USES:  See also Warning section.||
2052|045|U|   Ketoconazole is used to treat certain serious fungal||
2052|046|U|infections in the body. Ketoconazole belongs to the class of||
2052|047|U|drugs called azole antifungals. It works by stopping the growth||
2052|048|U|of the fungus.||
2052|049|U|   Ketoconazole should not be used to treat fungal infections on||
2052|050|U|the skin and nails due to the risk of serious side effects and||
2052|051|U|drug interactions. Talk to your doctor about other medications||
2052|052|U|you can use to treat these types of infection.||
2052|053|B|||
2052|054|V|OTHER USES:  This section contains uses of this drug that are not||
2052|055|V|listed in the approved professional labeling for the drug but||
2052|056|V|that may be prescribed by your health care professional. Use this||
2052|057|V|drug for a condition that is listed in this section only if it||
2052|058|V|has been so prescribed by your health care professional.||
2052|059|V|   This drug may also be used for advanced prostate cancer.||
2052|060|B|||
2052|061|H|HOW TO USE:  Read the Medication Guide provided by your||
2052|062|H|pharmacist before you start taking ketoconazole and each time you||
2052|063|H|get a refill. If you have any questions, ask your doctor or||
2052|064|H|pharmacist.||
2052|065|H|   Take this medication by mouth as directed by your doctor,||
2052|066|H|usually once a day. This medication may be taken with or without||
2052|067|H|food, but taking it with food helps to reduce stomach upset.||
2052|068|H|   If you are taking an antacid, take ketoconazole at least 2||
2052|069|H|hours before or 1 hour after taking the antacid, otherwise||
2052|070|H|ketoconazole may not be absorbed into the body. See also Drug||
2052|071|H|Interactions for more information.||
2052|072|H|   The dosage and length of treatment is based on your medical||
2052|073|H|condition, response to treatment, and other medications you may||
2052|074|H|be taking. Be sure to tell your doctor and pharmacist about all||
2052|075|H|the products you use (including prescription drugs,||
2052|076|H|nonprescription drugs, and herbal products). Children's dosage is||
2052|077|H|also based on weight. It may take from several days to several||
2052|078|H|months to complete treatment.||
2052|079|H|   This medication works best when the amount of medicine in your||
2052|080|H|body is kept at a constant level. Take this drug at evenly spaced||
2052|081|H|intervals. To help you remember, take it at the same time each||
2052|082|H|day.||
2052|083|H|   Continue to take this medication until the full prescribed||
2052|084|H|amount is finished, even if symptoms disappear after a few days.||
2052|085|H|Stopping the medication too early may result in a return of the||
2052|086|H|infection.||
2052|087|H|   Tell your doctor if your condition lasts or gets worse.||
2052|088|B|||
2052|089|S|SIDE EFFECTS:  See also Warning section.||
2052|090|S|   Nausea and vomiting may occur. If any of these effects last or||
2052|091|S|get worse, tell your doctor or pharmacist promptly.||
2052|092|S|   Remember that this medication has been prescribed because your||
2052|093|S|doctor has judged that the benefit to you is greater than the||
2052|094|S|risk of side effects. Many people using this medication do not||
2052|095|S|have serious side effects.||
2052|096|S|   Tell your doctor right away if you have any serious side||
2052|097|S|effects, including: headache, vision changes, mental/mood changes||
2052|098|S|(such as depression, thoughts of suicide).||
2052|099|S|   Although unlikely, when ketoconazole is used at high doses, it||
2052|100|S|may cause an adrenal gland problem (adrenal insufficiency), a||
2052|101|S|decrease in testosterone levels, and a decrease in sperm||
2052|102|S|production. Ketoconazole can also worsen existing adrenal gland||
2052|103|S|function problems (See also Precautions section). The adrenal||
2052|104|S|gland problem may make it more difficult for your body to respond||
2052|105|S|to physical stress. Before having surgery or emergency treatment,||
2052|106|S|or if you get a serious illness/injury, tell your doctor or||
2052|107|S|dentist that you are using this medication. Your doctor may order||
2052|108|S|a blood test to monitor your adrenal gland function while you are||
2052|109|S|taking ketoconazole. These effects usually go away after||
2052|110|S|ketoconazole treatment is stopped. Tell your doctor right away if||
2052|111|S|you have any serious side effects, including: unusual tiredness,||
2052|112|S|weakness, dizziness upon standing, diarrhea, weight loss,||
2052|113|S|menstrual period changes, decreased sexual interest or ability,||
2052|114|S|enlarged/tender breasts in men.||
2052|115|S|   Get medical help right away if you have any very serious side||
2052|116|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2052|117|S|fainting.||
2052|118|S|   A very serious allergic reaction to this drug is rare.||
2052|119|S|However, get medical help right away if you notice any symptoms||
2052|120|S|of a serious allergic reaction, including: rash, itching/swelling||
2052|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2052|122|S|breathing.||
2052|123|S|   This is not a complete list of possible side effects. If you||
2052|124|S|notice other effects not listed above, contact your doctor or||
2052|125|S|pharmacist.||
2052|126|S|   In the US -||
2052|127|S|   Call your doctor for medical advice about side effects. You||
2052|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2052|129|S|www.fda.gov/medwatch.||
2052|130|S|   In Canada - Call your doctor for medical advice about side||
2052|131|S|effects. You may report side effects to Health Canada at||
2052|132|S|1-866-234-2345.||
2052|133|B|||
2052|134|P|PRECAUTIONS:  See also Side Effects section.||
2052|135|P|   Before taking ketoconazole, tell your doctor or pharmacist if||
2052|136|P|you are allergic to it; or to levoketoconazole; or to other azole||
2052|137|P|antifungal drugs (such as fluconazole, itraconazole); or if you||
2052|138|P|have any other allergies. This product may contain inactive||
2052|139|P|ingredients, which can cause allergic reactions or other||
2052|140|P|problems. Talk to your pharmacist for more details.||
2052|141|P|   Before using this medication, tell your doctor or pharmacist||
2052|142|P|your medical history, especially of: liver problems, alcohol use,||
2052|143|P|low testosterone levels, decreased adrenal gland function||
2052|144|P|problems (such as low cortisol levels, Addison's disease, adrenal||
2052|145|P|insufficiency), little or no stomach acid production||
2052|146|P|(achlorhydria).||
2052|147|P|   Ketoconazole may cause a condition that affects the heart||
2052|148|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2052|149|P|serious (rarely fatal) fast/irregular heartbeat and other||
2052|150|P|symptoms (such as severe dizziness, fainting) that need medical||
2052|151|P|attention right away.||
2052|152|P|   The risk of QT prolongation may be increased if you have||
2052|153|P|certain medical conditions or are taking other drugs that may||
2052|154|P|cause QT prolongation. Before using ketoconazole, tell your||
2052|155|P|doctor or pharmacist of all the drugs you take and if you have||
2052|156|P|any of the following conditions: certain heart problems (heart||
2052|157|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2052|158|P|history of certain heart problems (QT prolongation in the EKG,||
2052|159|P|sudden cardiac death).||
2052|160|P|   Low levels of potassium or magnesium in the blood may also||
2052|161|P|increase your risk of QT prolongation. This risk may increase if||
2052|162|P|you use certain drugs (such as diuretics/"water pills") or if you||
2052|163|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2052|164|P|Talk to your doctor about using ketoconazole safely.||
2052|165|P|   Before having surgery, tell your doctor or dentist about all||
2052|166|P|the products you use (including prescription drugs,||
2052|167|P|nonprescription drugs, and herbal products).||
2052|168|P|   Do not drink alcoholic beverages while taking this medication||
2052|169|P|because alcohol increases the risk of serious liver problems.||
2052|170|P|Avoiding alcoholic beverages will also decrease the risk of a||
2052|171|P|rare reaction with ketoconazole that may result in flushing,||
2052|172|P|headache, and nausea.||
2052|173|P|   Older adults may be more sensitive to the side effects of this||
2052|174|P|drug, especially QT prolongation (see above).||
2052|175|P|   During pregnancy, this medication should be used only when||
2052|176|P|clearly needed. Discuss the risks and benefits with your doctor.||
2052|177|P|   This medication passes into breast milk. Consult your doctor||
2052|178|P|before breastfeeding.||
2052|179|B|||
2052|180|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
2052|181|I|   Drug interactions may change how your medications work or||
2052|182|I|increase your risk for serious side effects. This document does||
2052|183|I|not contain all possible drug interactions. Keep a list of all||
2052|184|I|the products you use (including prescription/nonprescription||
2052|185|I|drugs and herbal products) and share it with your doctor and||
2052|186|I|pharmacist. Do not start, stop, or change the dosage of any||
2052|187|I|medicines without your doctor's approval.||
2052|188|I|   Ketoconazole interacts with many prescription and||
2052|189|I|nonprescription drugs. While you are taking ketoconazole, it is||
2052|190|I|very important to tell your doctor or pharmacist of any changes||
2052|191|I|in medications that you are taking.||
2052|192|I|   Some products that may interact with this drug include: other||
2052|193|I|drugs that can cause liver problems (such as acetaminophen).||
2052|194|I|   Other medications can affect the removal of ketoconazole from||
2052|195|I|your body, which may affect how ketoconazole works. Examples||
2052|196|I|include isoniazid, nevirapine, rifamycins (such as rifabutin,||
2052|197|I|rifampin), St. John's wort, among others.||
2052|198|I|   This medication can slow down the removal of many other||
2052|199|I|medications from your body, which may affect how they work.||
2052|200|I|Examples of affected drugs include some benzodiazepines (such as||
2052|201|I|alprazolam, midazolam, triazolam), domperidone, eletriptan,||
2052|202|I|eplerenone, ergot drugs (such as ergotamine), nisoldipine, drugs||
2052|203|I|used to treat erectile dysfunction-ED or pulmonary hypertension||
2052|204|I|(such as sildenafil, tadalafil), some drugs used to treat||
2052|205|I|seizures (such as phenytoin), some statin drugs (such as||
2052|206|I|lovastatin, simvastatin), among others.||
2052|207|I|   Ketoconazole requires acid in the stomach to be well absorbed.||
2052|208|I|If you are taking drugs that decrease the amount of stomach acid||
2052|209|I|including antacids, heartburn/ulcer drugs (H2 blockers such as||
2052|210|I|cimetidine, famotidine, ranitidine), sucralfate, or if you are||
2052|211|I|taking drugs that slow down gut movement (anticholinergics such||
2052|212|I|as dicyclomine, propantheline), take ketoconazole at least 2||
2052|213|I|hours before any of these drugs. If you are taking proton pump||
2052|214|I|inhibitors (PPIs such as lansoprazole, omeprazole), ask your||
2052|215|I|doctor or pharmacist for advice on how to reduce or avoid this||
2052|216|I|interaction.||
2052|217|I|   Ketoconazole is very similar to levoketoconazole. Do not use||
2052|218|I|medications containing levoketoconazole while using ketoconazole.||
2052|219|B|||
2052|220|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2052|221|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2052|222|O|poison control center right away. US residents can call||
2052|223|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2052|224|B|||
2052|225|N|NOTES:  Do not share this medication with others.||
2052|226|N|   This medication has been prescribed for your current condition||
2052|227|N|only. Do not use it later for another infection unless your||
2052|228|N|doctor tells you to.||
2052|229|N|   Lab and/or medical tests (such as liver function, INR) must be||
2052|230|N|done before you start taking this medication and while you are||
2052|231|N|taking it. Keep all medical and lab appointments. Consult your||
2052|232|N|doctor for more details.||
2052|233|B|||
2052|234|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2052|235|D|remember. If it is near the time of the next dose, skip the||
2052|236|D|missed dose. Take your next dose at the regular time. Do not||
2052|237|D|double the dose to catch up.||
2052|238|B|||
2052|239|R|STORAGE:  Store at room temperature away from light and moisture.||
2052|240|R|Do not store in the bathroom. Keep all medications away from||
2052|241|R|children and pets.||
2052|242|R|   Do not flush medications down the toilet or pour them into a||
2052|243|R|drain unless instructed to do so. Properly discard this product||
2052|244|R|when it is expired or no longer needed. Consult your pharmacist||
2052|245|R|or local waste disposal company.||
2052|246|B|||
2052|247|A|Information last revised August 2024.||
2052|248|A|Copyright(c) 2025 First Databank, Inc.||
2052|249|B|||
2054|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2054|002|Z|does NOT have all possible information about this product. This||
2054|003|Z|information does not assure that this product is safe, effective,||
2054|004|Z|or appropriate for you. This information is not individual||
2054|005|Z|medical advice and does not substitute for the advice of your||
2054|006|Z|health care professional. Always ask your health care||
2054|007|Z|professional for complete information about this product and your||
2054|008|Z|specific health needs.||
2054|009|B|||
2054|010|T|ALPELISIB (ANTI-CANCER) - ORAL||
2054|011|F|(AL-pe-LIS-ib)||
2054|012|B|||
2054|013|C|COMMON BRAND NAME(S): Piqray||
2054|014|B|||
2054|015|U|USES:  This medication is used to treat certain types of breast||
2054|016|U|cancer. Alpelisib belongs to a class of drugs known as kinase||
2054|017|U|inhibitors. It works by slowing or stopping the growth of cancer||
2054|018|U|cells.||
2054|019|B|||
2054|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2054|021|H|from your pharmacist before you start taking alpelisib and each||
2054|022|H|time you get a refill. If you have any questions, ask your doctor||
2054|023|H|or pharmacist.||
2054|024|H|   Take this medication by mouth with food as directed by your||
2054|025|H|doctor, usually once daily. Swallow the tablets whole. Do not||
2054|026|H|chew, crush, or split the tablets. Do not take tablets that look||
2054|027|H|damaged, or are broken or cracked.||
2054|028|H|   The dosage is based on your medical condition and response to||
2054|029|H|treatment.||
2054|030|H|   Use this medication regularly to get the most benefit from it.||
2054|031|H|To help you remember, take it at the same time each day.||
2054|032|H|   If you vomit after taking a dose, do not take another dose on||
2054|033|H|the same day. Wait until the next day to take your dose at the||
2054|034|H|regular time.||
2054|035|H|   Do not increase your dose or use this drug more often or for||
2054|036|H|longer than prescribed. Your condition will not improve any||
2054|037|H|faster, and your risk of side effects will increase.||
2054|038|H|   Since this drug can be absorbed through the skin and lungs and||
2054|039|H|may harm an unborn baby, women who are pregnant or who may become||
2054|040|H|pregnant should not handle this medication or breathe the dust||
2054|041|H|from the tablets.||
2054|042|B|||
2054|043|S|SIDE EFFECTS:  Nausea, vomiting, tiredness, change in how food||
2054|044|S|tastes, loss of appetite, decreased weight, or dry skin may||
2054|045|S|occur. If any of these effects last or get worse, tell your||
2054|046|S|doctor or pharmacist promptly.||
2054|047|S|   Diarrhea commonly occurs. Severe diarrhea can lead to||
2054|048|S|dehydration and kidney problems. If you have diarrhea, tell your||
2054|049|S|doctor right away. Drink enough fluids to prevent dehydration and||
2054|050|S|ask your doctor or pharmacist about medicines to treat diarrhea.||
2054|051|S|   Pain or sores in the mouth and throat may occur. Brush your||
2054|052|S|teeth carefully/gently, avoid using mouthwash that contains||
2054|053|S|alcohol, and rinse your mouth often with cool water mixed with||
2054|054|S|baking soda or salt. It may also be best to eat soft, moist||
2054|055|S|foods.||
2054|056|S|   Temporary hair loss may occur. Normal hair growth should||
2054|057|S|return after treatment has ended.||
2054|058|S|   People using this medication may have serious side effects.||
2054|059|S|However, you have been prescribed this drug because your doctor||
2054|060|S|has judged that the benefit to you is greater than the risk of||
2054|061|S|side effects. Careful monitoring by your doctor may decrease your||
2054|062|S|risk.||
2054|063|S|   Tell your doctor right away if you have any serious side||
2054|064|S|effects, including: symptoms of lung problems (such as shortness||
2054|065|S|of breath, cough, chest pain), abdominal pain, blood/mucus in||
2054|066|S|stool.||
2054|067|S|   This medication may make your blood sugar rise, which can||
2054|068|S|cause or worsen diabetes. Tell your doctor right away if you have||
2054|069|S|symptoms of high blood sugar, such as increased thirst/urination.||
2054|070|S|If you already have diabetes, check your blood sugar regularly as||
2054|071|S|directed and share the results with your doctor. Your doctor may||
2054|072|S|need to adjust your diabetes medication, exercise program, or||
2054|073|S|diet.||
2054|074|S|   A very serious allergic reaction to this drug is rare.||
2054|075|S|However, get medical help right away if you notice any symptoms||
2054|076|S|of a serious allergic reaction, including: fever, swollen lymph||
2054|077|S|nodes, rash, itching/swelling (especially of the||
2054|078|S|face/tongue/throat), severe dizziness, trouble breathing.||
2054|079|S|   This is not a complete list of possible side effects. If you||
2054|080|S|notice any other effects not listed above, contact your doctor or||
2054|081|S|pharmacist.||
2054|082|S|   In the US -||
2054|083|S|   Call your doctor for medical advice about side effects. You||
2054|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2054|085|S|www.fda.gov/medwatch.||
2054|086|S|   In Canada - Call your doctor for medical advice about side||
2054|087|S|effects. You may report side effects to Health Canada at||
2054|088|S|1-866-234-2345.||
2054|089|B|||
2054|090|P|PRECAUTIONS:  Before taking alpelisib, tell your doctor or||
2054|091|P|pharmacist if you are allergic to it; or if you have any other||
2054|092|P|allergies. This product may contain inactive ingredients, which||
2054|093|P|can cause allergic reactions or other problems. Talk to your||
2054|094|P|pharmacist for more details.||
2054|095|P|   Before using this medication, tell your doctor or pharmacist||
2054|096|P|your medical history, especially of: diabetes, liver disease,||
2054|097|P|history of severe skin reactions (such as Stevens-Johnson||
2054|098|P|syndrome, erythema multiforme, toxic epidermal necrolysis).||
2054|099|P|   Before having surgery, tell your doctor or dentist about all||
2054|100|P|the products you use (including prescription drugs,||
2054|101|P|nonprescription drugs, and herbal products).||
2054|102|P|   Older adults may be more sensitive to the side effects of this||
2054|103|P|drug, especially increased blood sugar.||
2054|104|P|   Since this drug can be absorbed through the skin and lungs and||
2054|105|P|may harm an unborn baby, women who are pregnant or who may become||
2054|106|P|pregnant should not handle this medication or breathe the dust||
2054|107|P|from the tablets.||
2054|108|P|   Tell your doctor if you are pregnant or plan to become||
2054|109|P|pregnant. You should not become pregnant while using alpelisib.||
2054|110|P|Alpelisib may harm an unborn baby. Your doctor should order a||
2054|111|P|pregnancy test before you start this medication. Men and women||
2054|112|P|using this medication should ask about reliable forms of birth||
2054|113|P|control during treatment and for 1 week after the last dose. If||
2054|114|P|you or your partner becomes pregnant, talk to your doctor right||
2054|115|P|away about the risks and benefits of this medication.||
2054|116|P|   It is unknown if this medication passes into breast milk.||
2054|117|P|Because of the possible risk to the infant, breastfeeding is not||
2054|118|P|recommended while using this medication and for 1 week after the||
2054|119|P|last dose. Consult your doctor before breastfeeding.||
2054|120|B|||
2054|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2054|122|I|medications work or increase your risk for serious side effects.||
2054|123|I|This document does not contain all possible drug interactions.||
2054|124|I|Keep a list of all the products you use (including||
2054|125|I|prescription/nonprescription drugs and herbal products) and share||
2054|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
2054|127|I|the dosage of any medicines without your doctor's approval.||
2054|128|I|   Other medications can affect the removal of alpelisib from||
2054|129|I|your body, which may affect how alpelisib works. Examples include||
2054|130|I|apalutamide, rifamycins (such as rifampin), St. John's wort,||
2054|131|I|drugs used to treat seizures (such as carbamazepine, phenytoin),||
2054|132|I|among others.||
2054|133|B|||
2054|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2054|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2054|136|O|poison control center right away. US residents can call||
2054|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2054|138|B|||
2054|139|N|NOTES:  Do not share this medication with others.||
2054|140|N|   Lab and/or medical tests (such as complete blood count, blood||
2054|141|N|sugar, kidney/liver function) should be done while you are taking||
2054|142|N|this medication. Keep all medical and lab appointments.||
2054|143|B|||
2054|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2054|145|D|remember. If it is more than 9 hours after the missed dose, skip||
2054|146|D|the missed dose. Take your next dose at the regular time. Do not||
2054|147|D|double the dose to catch up.||
2054|148|B|||
2054|149|R|STORAGE:  Store in the original container at room temperature||
2054|150|R|away from light and moisture. Do not store in the bathroom. Keep||
2054|151|R|all medications away from children and pets.||
2054|152|R|   Do not flush medications down the toilet or pour them into a||
2054|153|R|drain unless instructed to do so. Properly discard this product||
2054|154|R|when it is expired or no longer needed. Consult your pharmacist||
2054|155|R|or local waste disposal company.||
2054|156|B|||
2054|157|A|Information last revised June 2024.||
2054|158|A|Copyright(c) 2025 First Databank, Inc.||
2054|159|B|||
2055|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2055|002|Z|does NOT have all possible information about this product. This||
2055|003|Z|information does not assure that this product is safe, effective,||
2055|004|Z|or appropriate for you. This information is not individual||
2055|005|Z|medical advice and does not substitute for the advice of your||
2055|006|Z|health care professional. Always ask your health care||
2055|007|Z|professional for complete information about this product and your||
2055|008|Z|specific health needs.||
2055|009|B|||
2055|010|T|POLATUZUMAB - INJECTION||
2055|011|F|(POL-a-TOOZ-ue-mab)||
2055|012|B|||
2055|013|C|COMMON BRAND NAME(S): Polivy||
2055|014|B|||
2055|015|U|USES:  Polatuzumab is used to treat certain types of cancer||
2055|016|U|(diffuse large B-cell lymphoma-DLBCL, high-grade B-cell||
2055|017|U|lymphoma-HGBL). This medication works by stopping the growth of||
2055|018|U|cancer cells.||
2055|019|B|||
2055|020|H|HOW TO USE:  This medication is given by slow injection into a||
2055|021|H|vein by a health care professional. The dosage is based on your||
2055|022|H|medical condition, weight, and response to treatment.||
2055|023|H|   Before you receive this medication, your doctor may prescribe||
2055|024|H|other medications (such as antibiotics, antivirals) to help||
2055|025|H|prevent infection.||
2055|026|H|   Infusion reactions may happen during the infusion of this drug||
2055|027|H|and for up to 24 hours afterward. Your doctor may prescribe other||
2055|028|H|medications (such as acetaminophen, diphenhydramine) before each||
2055|029|H|treatment to help prevent these side effects.Tell your doctor||
2055|030|H|right away if you have any symptoms of infusion reactions such as||
2055|031|H|fever, chills, shortness of breath, flushing, itching, or||
2055|032|H|dizziness.||
2055|033|B|||
2055|034|S|SIDE EFFECTS:  See also How to Use section.||
2055|035|S|   Dizziness, vomiting, diarrhea, loss of appetite, or weight||
2055|036|S|loss may occur. If any of these effects last or get worse, tell||
2055|037|S|your doctor or pharmacist promptly.||
2055|038|S|   People using this medication may have serious side effects.||
2055|039|S|However, you have been prescribed this drug because your doctor||
2055|040|S|has judged that the benefit to you is greater than the risk of||
2055|041|S|side effects. Careful monitoring by your doctor may decrease your||
2055|042|S|risk.||
2055|043|S|   Tell your doctor right away if you have any serious side||
2055|044|S|effects, including: numbness/tingling/weakness/pain of the||
2055|045|S|hands/feet/arms/legs, signs of liver disease (such as||
2055|046|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain,||
2055|047|S|yellowing eyes/skin).||
2055|048|S|   This medication decreases bone marrow function, an effect that||
2055|049|S|may lead to a low number of blood cells such as red cells, white||
2055|050|S|cells, and platelets. This effect can cause anemia, decrease your||
2055|051|S|body's ability to fight an infection, or cause easy||
2055|052|S|bruising/bleeding. This may make you more likely to get a serious||
2055|053|S|(rarely fatal) infection or make any infection you have worse.||
2055|054|S|Tell your doctor right away if you develop any of the following||
2055|055|S|symptoms: unusual tiredness, pale skin, signs of infection (such||
2055|056|S|as sore throat that doesn't go away, fever, chills, shortness of||
2055|057|S|breath), easy bruising/bleeding.||
2055|058|S|   Polatuzumab sometimes causes side effects due to the rapid||
2055|059|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
2055|060|S|risk, your doctor may add a medication and tell you to drink||
2055|061|S|plenty of fluids. Tell your doctor right away if you have||
2055|062|S|symptoms such as: low back/side pain (flank pain), signs of||
2055|063|S|kidney problems (such as painful urination, pink/bloody urine,||
2055|064|S|change in the amount of urine), muscle spasms/weakness.||
2055|065|S|   This medication may increase your risk of getting a rare but||
2055|066|S|very serious (possibly fatal) brain infection (progressive||
2055|067|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2055|068|S|if you have any of these side effects: clumsiness, loss of||
2055|069|S|coordination/balance, weakness, sudden change in your thinking||
2055|070|S|(such as confusion, difficulty concentrating, memory loss),||
2055|071|S|difficulty talking/walking, seizure, vision changes.||
2055|072|S|   A very serious allergic reaction to this drug is rare.||
2055|073|S|However, get medical help right away if you notice any symptoms||
2055|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2055|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2055|076|S|breathing.||
2055|077|S|   This is not a complete list of possible side effects. If you||
2055|078|S|notice other effects not listed above, contact your doctor or||
2055|079|S|pharmacist.||
2055|080|S|   In the US -||
2055|081|S|   Call your doctor for medical advice about side effects. You||
2055|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2055|083|S|www.fda.gov/medwatch.||
2055|084|S|   In Canada - Call your doctor for medical advice about side||
2055|085|S|effects. You may report side effects to Health Canada at||
2055|086|S|1-866-234-2345.||
2055|087|B|||
2055|088|P|PRECAUTIONS:  Before receiving this medication, tell your doctor||
2055|089|P|or pharmacist if you are allergic to it; or if you have ever had||
2055|090|P|a severe reaction to it; or if you have any other allergies. This||
2055|091|P|product may contain inactive ingredients, which can cause||
2055|092|P|allergic reactions or other problems. Talk to your pharmacist for||
2055|093|P|more details.||
2055|094|P|   Before using this medication, tell your doctor or pharmacist||
2055|095|P|your medical history, especially of: recent/current infections,||
2055|096|P|liver disease, kidney disease.||
2055|097|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2055|098|P|can make you more dizzy. Do not drive, use machinery, or do||
2055|099|P|anything that needs alertness until you can do it safely. Limit||
2055|100|P|alcoholic beverages. Talk to your doctor if you are using||
2055|101|P|marijuana (cannabis).||
2055|102|P|   Before having surgery, tell your doctor or dentist about all||
2055|103|P|the products you use (including prescription drugs,||
2055|104|P|nonprescription drugs, and herbal products).||
2055|105|P|   Polatuzumab can make you more likely to get infections or may||
2055|106|P|make current infections worse. Stay away from anyone who has an||
2055|107|P|infection that may easily spread (such as chickenpox, COVID-19,||
2055|108|P|measles, flu). Talk to your doctor if you have been exposed to an||
2055|109|P|infection or for more details.||
2055|110|P|   Tell your health care professional that you are using||
2055|111|P|polatuzumab before having any immunizations/vaccinations. Avoid||
2055|112|P|contact with people who have recently received live vaccines||
2055|113|P|(such as flu vaccine inhaled through the nose).||
2055|114|P|   To lower the chance of getting cut, bruised, or injured, use||
2055|115|P|caution with sharp objects like razors and nail cutters, and||
2055|116|P|avoid activities such as contact sports.||
2055|117|P|   Tell your doctor if you are pregnant or plan to become||
2055|118|P|pregnant. You should not become pregnant while using polatuzumab.||
2055|119|P|Polatuzumab may harm an unborn baby. Your doctor should order a||
2055|120|P|pregnancy test before you start this medication. Women using this||
2055|121|P|medication should ask about reliable forms of birth control||
2055|122|P|during treatment and for 3 months after the last dose. Men using||
2055|123|P|this medication should ask about reliable forms of birth control||
2055|124|P|during treatment and for 5 months after the last dose. If you or||
2055|125|P|your partner becomes pregnant, talk to your doctor right away||
2055|126|P|about the risks and benefits of this medication.||
2055|127|P|   It is unknown if this drug passes into breast milk. Because of||
2055|128|P|the possible risk to the infant, breastfeeding is not recommended||
2055|129|P|while using this drug and for at least 2 months after the last||
2055|130|P|dose. Consult your doctor before breastfeeding.||
2055|131|B|||
2055|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2055|133|I|medications work or increase your risk for serious side effects.||
2055|134|I|This document does not contain all possible drug interactions.||
2055|135|I|Keep a list of all the products you use (including||
2055|136|I|prescription/nonprescription drugs and herbal products) and share||
2055|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
2055|138|I|the dosage of any medicines without your doctor's approval.||
2055|139|I|   Some products that may interact with this drug are: other||
2055|140|I|drugs that weaken the immune system/increase the risk of||
2055|141|I|infection (such as natalizumab, rituximab).||
2055|142|B|||
2055|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2055|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2055|145|O|poison control center right away. US residents can call||
2055|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2055|147|B|||
2055|148|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2055|149|N|kidney/liver function, blood mineral levels) should be done while||
2055|150|N|you are using this medication. Keep all medical and lab||
2055|151|N|appointments. Consult your doctor for more details.||
2055|152|B|||
2055|153|D|MISSED DOSE:  It is important to get each dose of this medication||
2055|154|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2055|155|D|right away for a new dosing schedule.||
2055|156|B|||
2055|157|R|STORAGE:  Not applicable. This medication is given in a hospital||
2055|158|R|or clinic and will not be stored at home.||
2055|159|B|||
2055|160|M|MEDICAL ALERT:  Your condition can cause complications in a||
2055|161|M|medical emergency. For information about enrolling in MedicAlert,||
2055|162|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2055|163|B|||
2055|164|A|Information last revised May 2024.||
2055|165|A|Copyright(c) 2025 First Databank, Inc.||
2055|166|B|||
2056|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2056|002|Z|does NOT have all possible information about this product. This||
2056|003|Z|information does not assure that this product is safe, effective,||
2056|004|Z|or appropriate for you. This information is not individual||
2056|005|Z|medical advice and does not substitute for the advice of your||
2056|006|Z|health care professional. Always ask your health care||
2056|007|Z|professional for complete information about this product and your||
2056|008|Z|specific health needs.||
2056|009|B|||
2056|010|T|AMIFAMPRIDINE - ORAL||
2056|011|F|(AM-i-FAM-pri-deen)||
2056|012|B|||
2056|013|C|COMMON BRAND NAME(S): Ruzurgi||
2056|014|B|||
2056|015|U|USES:  Amifampridine is used to treat a certain disorder that||
2056|016|U|affects nerves and muscles (Lambert-Eaton syndrome). This||
2056|017|U|disorder causes your body's immune system to attack healthy nerve||
2056|018|U|cells, which results in muscle weakness. It is not known exactly||
2056|019|U|how this medication works, but it can help lessen symptoms of||
2056|020|U|muscle weakness and loss of movement caused by Lambert-Eaton||
2056|021|U|syndrome.||
2056|022|B|||
2056|023|H|HOW TO USE:  Read the Medication Guide provided by your||
2056|024|H|pharmacist before you start taking amifampridine and each time||
2056|025|H|you get a refill. If you have any questions, ask your doctor or||
2056|026|H|pharmacist.||
2056|027|H|   Take this medication by mouth with or without food as directed||
2056|028|H|by your doctor. The dosage is based on your medical condition,||
2056|029|H|weight, and response to treatment. To reduce your risk of side||
2056|030|H|effects, your doctor may direct you to start this medication at a||
2056|031|H|low dose and gradually increase your dose. Follow your doctor's||
2056|032|H|instructions carefully.||
2056|033|H|   If you need a dose that doesn't match taking half and/or whole||
2056|034|H|tablets together, or have trouble swallowing tablets, or receive||
2056|035|H|medication through a feeding tube, you may make a liquid||
2056|036|H|suspension with this medication. Read and follow the||
2056|037|H|manufacturer's directions (Instructions for Use leaflet) to make||
2056|038|H|a suspension with the tablet(s) and sterile water. Ask your||
2056|039|H|doctor or pharmacist about what you need to make the suspension.||
2056|040|H|Shake the suspension well before measuring each dose. Carefully||
2056|041|H|measure the dose using a special measuring device/spoon. Do not||
2056|042|H|use a household spoon because you may not get the correct dose.||
2056|043|H|Refrigerate the suspension between doses. Prepare fresh||
2056|044|H|suspensions daily. Throw away any unused suspension after 24||
2056|045|H|hours.||
2056|046|H|   Use this medication regularly to get the most benefit from it.||
2056|047|H|To help you remember, take it at the same times each day.||
2056|048|H|   Tell your doctor if your condition does not get better or if||
2056|049|H|it gets worse.||
2056|050|B|||
2056|051|S|SIDE EFFECTS:  Numbness/tingling around the mouth, tongue, face,||
2056|052|S|fingers, toes, and other body parts may occur. Nausea, diarrhea,||
2056|053|S|constipation, headache, stomach/back pain, muscle spasms, or||
2056|054|S|dizziness may also occur. If any of these effects last or get||
2056|055|S|worse, tell your doctor or pharmacist promptly.||
2056|056|S|   Remember that this medication has been prescribed because your||
2056|057|S|doctor has judged that the benefit to you is greater than the||
2056|058|S|risk of side effects. Many people using this medication do not||
2056|059|S|have serious side effects.||
2056|060|S|   Tell your doctor right away if you have any serious side||
2056|061|S|effects, including: vision changes (such as blurred vision).||
2056|062|S|   Get medical help right away if you have any very serious side||
2056|063|S|effects, including: seizure.||
2056|064|S|   A very serious allergic reaction to this drug is rare.||
2056|065|S|However, get medical help right away if you notice any symptoms||
2056|066|S|of a serious allergic reaction, including: rash, itching/swelling||
2056|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2056|068|S|breathing.||
2056|069|S|   This is not a complete list of possible side effects. If you||
2056|070|S|notice other effects not listed above, contact your doctor or||
2056|071|S|pharmacist.||
2056|072|S|   In the US -||
2056|073|S|   Call your doctor for medical advice about side effects. You||
2056|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2056|075|S|www.fda.gov/medwatch.||
2056|076|S|   In Canada - Call your doctor for medical advice about side||
2056|077|S|effects. You may report side effects to Health Canada at||
2056|078|S|1-866-234-2345.||
2056|079|B|||
2056|080|P|PRECAUTIONS:  Before taking amifampridine, tell your doctor or||
2056|081|P|pharmacist if you are allergic to it; or to amifampridine||
2056|082|P|phosphate; or if you have any other allergies. This product may||
2056|083|P|contain inactive ingredients, which can cause allergic reactions||
2056|084|P|or other problems. Talk to your pharmacist for more details.||
2056|085|P|   Before using this medication, tell your doctor or pharmacist||
2056|086|P|your medical history, especially of: kidney problems, liver||
2056|087|P|problems, seizure.||
2056|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2056|089|P|can make you more dizzy. Do not drive, use machinery, or do||
2056|090|P|anything that needs alertness until you can do it safely. Limit||
2056|091|P|alcoholic beverages. Talk to your doctor if you are using||
2056|092|P|marijuana (cannabis).||
2056|093|P|   Before having surgery, tell your doctor or dentist about all||
2056|094|P|the products you use (including prescription drugs,||
2056|095|P|nonprescription drugs, and herbal products).||
2056|096|P|   During pregnancy, this medication should be used only when||
2056|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
2056|098|P|   It is unknown if this medication passes into breast milk.||
2056|099|P|Consult your doctor before breastfeeding.||
2056|100|B|||
2056|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2056|102|I|medications work or increase your risk for serious side effects.||
2056|103|I|This document does not contain all possible drug interactions.||
2056|104|I|Keep a list of all the products you use (including||
2056|105|I|prescription/nonprescription drugs and herbal products) and share||
2056|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
2056|107|I|the dosage of any medicines without your doctor's approval.||
2056|108|I|   Amifampridine is very similar to amifampridine phosphate. Do||
2056|109|I|not use amifampridine phosphate while using amifampridine.||
2056|110|B|||
2056|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2056|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2056|113|O|poison control center right away. US residents can call||
2056|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2056|115|O|Symptoms of overdose may include: severe dizziness,||
2056|116|O|fast/irregular heartbeat, fainting.||
2056|117|B|||
2056|118|N|NOTES:  Do not share this medication with others.||
2056|119|B|||
2056|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2056|121|D|remember. If it is near the time of the next dose, skip the||
2056|122|D|missed dose. Take your next dose at the regular time. Do not||
2056|123|D|double the dose to catch up.||
2056|124|B|||
2056|125|R|STORAGE:  Store at room temperature away from light and moisture.||
2056|126|R|Do not store in the bathroom. Keep all medications away from||
2056|127|R|children and pets.||
2056|128|R|   If you are using the liquid suspension, store it in the||
2056|129|R|refrigerator. After mixing, discard any unused suspension after||
2056|130|R|24 hours. (See also How to Use section)||
2056|131|R|   Do not flush medications down the toilet or pour them into a||
2056|132|R|drain unless instructed to do so. Properly discard this product||
2056|133|R|when it is expired or no longer needed. Consult your pharmacist||
2056|134|R|or local waste disposal company.||
2056|135|B|||
2056|136|A|Information last revised May 2024.||
2056|137|A|Copyright(c) 2025 First Databank, Inc.||
2056|138|B|||
2057|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2057|002|Z|does NOT have all possible information about this product. This||
2057|003|Z|information does not assure that this product is safe, effective,||
2057|004|Z|or appropriate for you. This information is not individual||
2057|005|Z|medical advice and does not substitute for the advice of your||
2057|006|Z|health care professional. Always ask your health care||
2057|007|Z|professional for complete information about this product and your||
2057|008|Z|specific health needs.||
2057|009|B|||
2057|010|T|PHENYTOIN CHEWABLE TABLET - ORAL||
2057|011|F|(FEN-i-toyn)||
2057|012|B|||
2057|013|C|COMMON BRAND NAME(S): Dilantin||
2057|014|B|||
2057|015|U|USES:  Phenytoin is used to prevent and control seizures (also||
2057|016|U|called an anticonvulsant or antiepileptic drug). It works by||
2057|017|U|reducing the spread of seizure activity in the brain.||
2057|018|B|||
2057|019|V|OTHER USES:  This section contains uses of this drug that are not||
2057|020|V|listed in the approved professional labeling for the drug but||
2057|021|V|that may be prescribed by your health care professional. Use this||
2057|022|V|drug for a condition that is listed in this section only if it||
2057|023|V|has been so prescribed by your health care professional.||
2057|024|V|   This drug may also be used for certain types of irregular||
2057|025|V|heartbeats.||
2057|026|B|||
2057|027|H|HOW TO USE:  Read the Medication Guide provided by your||
2057|028|H|pharmacist before you start taking phenytoin and each time you||
2057|029|H|get a refill. If you have any questions, ask your doctor or||
2057|030|H|pharmacist.||
2057|031|H|   The tablets may be chewed thoroughly before swallowing or||
2057|032|H|swallowed whole.||
2057|033|H|   Take this medication by mouth as directed by your doctor,||
2057|034|H|usually 2 or 3 times a day. This product is not recommended for||
2057|035|H|use once a day. You may take it with food if stomach upset||
2057|036|H|occurs. Take this medication with a full glass (8 ounces or 240||
2057|037|H|milliliters) of water unless your doctor directs you otherwise.||
2057|038|H|   Use this medication regularly in order to get the most benefit||
2057|039|H|from it. It is important to take all doses on time to keep the||
2057|040|H|amount of medicine in your body at a constant level. Remember to||
2057|041|H|use it at the same times each day. The dosage is based on your||
2057|042|H|medical condition, lab tests, and response to treatment.||
2057|043|H|Children's dosage is also based on weight.||
2057|044|H|   Antacids and nutritional tube-feeding (enteral) products may||
2057|045|H|decrease the absorption of phenytoin. Do not take these products||
2057|046|H|at the same time as your phenytoin dose. Separate liquid||
2057|047|H|nutritional products at least 1 hour before and 1 hour after your||
2057|048|H|phenytoin dose, or as directed by your doctor.||
2057|049|H|   Do not stop taking this medication without consulting your||
2057|050|H|doctor. Seizures may become worse when the drug is suddenly||
2057|051|H|stopped. Your dose may need to be gradually decreased.||
2057|052|H|   Tell your doctor if your condition does not get better or if||
2057|053|H|it gets worse.||
2057|054|B|||
2057|055|S|SIDE EFFECTS:  Headache, nausea, vomiting, constipation,||
2057|056|S|dizziness, feeling of spinning, drowsiness, trouble sleeping, or||
2057|057|S|nervousness may occur. If any of these effects last or get worse,||
2057|058|S|tell your doctor or pharmacist promptly.||
2057|059|S|   Phenytoin may cause swelling and bleeding of the gums. Massage||
2057|060|S|your gums and brush and floss your teeth regularly to minimize||
2057|061|S|this problem. See your dentist regularly.||
2057|062|S|   Remember that this medication has been prescribed because your||
2057|063|S|doctor has judged that the benefit to you is greater than the||
2057|064|S|risk of side effects. Many people using this medication do not||
2057|065|S|have serious side effects.||
2057|066|S|   Tell your doctor right away if you have any serious side||
2057|067|S|effects, including: slow heartbeat, unusual eye movements, loss||
2057|068|S|of coordination, trouble speaking, confusion, muscle twitching,||
2057|069|S|double/blurred vision, tingling of the hands/feet, facial changes||
2057|070|S|(such as swollen lips, butterfly-shaped rash around the||
2057|071|S|nose/cheeks), excessive hair growth, increased thirst/urination,||
2057|072|S|unusual tiredness, bone/joint pain, easily broken bones.||
2057|073|S|   A small number of people who take anticonvulsants for any||
2057|074|S|condition (such as seizure, bipolar disorder, pain) may||
2057|075|S|experience depression, suicidal thoughts/attempts, or other||
2057|076|S|mental/mood problems. Tell your doctor right away if you or your||
2057|077|S|family/caregiver notice any unusual/sudden changes in your mood,||
2057|078|S|thoughts, or behavior including signs of depression, suicidal||
2057|079|S|thoughts/attempts, thoughts about harming yourself.||
2057|080|S|   Rarely, males may have a painful or prolonged erection lasting||
2057|081|S|4 or more hours. If this occurs, stop using this drug and get||
2057|082|S|medical help right away, or permanent problems could occur.||
2057|083|S|   Get medical help right away if you have any very serious side||
2057|084|S|effects, including: uncontrolled muscle movements, signs of liver||
2057|085|S|problems (such as nausea/vomiting that doesn't stop,||
2057|086|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
2057|087|S|bruising/bleeding.||
2057|088|S|   A very serious allergic reaction to this drug is rare.||
2057|089|S|However, get medical help right away if you notice any symptoms||
2057|090|S|of a serious allergic reaction, including: fever, swollen lymph||
2057|091|S|nodes, rash, itching/swelling (especially of the||
2057|092|S|face/tongue/throat), severe dizziness, trouble breathing.||
2057|093|S|   This is not a complete list of possible side effects. If you||
2057|094|S|notice other effects not listed above, contact your doctor or||
2057|095|S|pharmacist.||
2057|096|S|   In the US -||
2057|097|S|   Call your doctor for medical advice about side effects. You||
2057|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2057|099|S|www.fda.gov/medwatch.||
2057|100|S|   In Canada - Call your doctor for medical advice about side||
2057|101|S|effects. You may report side effects to Health Canada at||
2057|102|S|1-866-234-2345.||
2057|103|B|||
2057|104|P|PRECAUTIONS:  Before taking phenytoin, tell your doctor or||
2057|105|P|pharmacist if you are allergic to it; or to other anti-seizure||
2057|106|P|medications (such as carbamazepine, ethosuximide, ethotoin,||
2057|107|P|fosphenytoin, oxcarbazepine, phenobarbital, primidone,||
2057|108|P|trimethadione); or if you have any other allergies. This product||
2057|109|P|may contain inactive ingredients, which can cause allergic||
2057|110|P|reactions or other problems. Talk to your pharmacist for more||
2057|111|P|details.||
2057|112|P|   Before using this medication, tell your doctor or pharmacist||
2057|113|P|your medical history, especially of: alcohol use, certain blood||
2057|114|P|conditions (porphyria), diabetes, liver disease (including liver||
2057|115|P|disease caused by past phenytoin use), lupus, folate or vitamin||
2057|116|P|B-12 deficiency (megaloblastic anemia).||
2057|117|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2057|118|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2057|119|P|machinery, or do anything that needs alertness until you can do||
2057|120|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2057|121|P|are using marijuana (cannabis). Alcohol may also affect your||
2057|122|P|blood levels of this drug.||
2057|123|P|   Before having surgery, tell your doctor or dentist about all||
2057|124|P|the products you use (including prescription drugs,||
2057|125|P|nonprescription drugs, and herbal products).||
2057|126|P|   If you have diabetes, this product may make it harder to||
2057|127|P|control your blood sugar. Check your blood sugar regularly as||
2057|128|P|directed and share the results with your doctor. Your doctor may||
2057|129|P|need to adjust your diabetes medication, exercise program, or||
2057|130|P|diet.||
2057|131|P|   Vitamin D supplements may be necessary to prevent weakening of||
2057|132|P|the bones (osteomalacia). Discuss this with your doctor.||
2057|133|P|   During pregnancy, this medication should be used only when||
2057|134|P|clearly needed. It may harm an unborn baby. However, since||
2057|135|P|untreated seizures are a serious condition that can harm both a||
2057|136|P|pregnant woman and her unborn baby, do not stop taking this||
2057|137|P|medication unless directed by your doctor. If you are planning||
2057|138|P|pregnancy, become pregnant, or think you may be pregnant,||
2057|139|P|immediately talk to your doctor about the benefits and risks of||
2057|140|P|using this medication during pregnancy. Since birth control||
2057|141|P|pills, patches, implants, and injections may not work if taken||
2057|142|P|with this medication (see also Drug Interactions section),||
2057|143|P|discuss reliable forms of birth control with your doctor.||
2057|144|P|   Phenytoin passes into breast milk. Consult your doctor before||
2057|145|P|breastfeeding.||
2057|146|B|||
2057|147|I|DRUG INTERACTIONS:  See also How to Use section.||
2057|148|I|   Drug interactions may change how your medications work or||
2057|149|I|increase your risk for serious side effects. This document does||
2057|150|I|not contain all possible drug interactions. Keep a list of all||
2057|151|I|the products you use (including prescription/nonprescription||
2057|152|I|drugs and herbal products) and share it with your doctor and||
2057|153|I|pharmacist. Do not start, stop, or change the dosage of any||
2057|154|I|medicines without your doctor's approval.||
2057|155|I|   Some products that may interact with this drug include:||
2057|156|I|colesevelam, orlistat, sucralfate.||
2057|157|I|   Other medications can affect the removal of phenytoin from||
2057|158|I|your body, which may affect how phenytoin works. Examples include||
2057|159|I|amiodarone, azapropazone, azole antifungals (such as||
2057|160|I|itraconazole), macrolide antibiotics (such as erythromycin),||
2057|161|I|estrogens, isoniazid, rifamycins (such as rifabutin), St. John's||
2057|162|I|wort, among others.||
2057|163|I|   Phenytoin can speed up the removal of other medications from||
2057|164|I|your body, which may affect how they work. Examples of affected||
2057|165|I|drugs include atazanavir, some drugs to treat cancer (such as||
2057|166|I|imatinib, irinotecan), cobicistat, corticosteroids (such as||
2057|167|I|prednisone), doravirine, etravirine, felodipine, nisoldipine,||
2057|168|I|quetiapine, quinidine, rilpivirine, suvorexant, telithromycin,||
2057|169|I|theophylline, vitamin D, among others.||
2057|170|I|   This medication may decrease the effectiveness of hormonal||
2057|171|I|birth control such as pills, patch, or ring. This could cause||
2057|172|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2057|173|I|use reliable backup birth control methods while using this||
2057|174|I|medication. Also tell your doctor if you have any new spotting or||
2057|175|I|breakthrough bleeding, because these may be signs that your birth||
2057|176|I|control is not working well.||
2057|177|I|   This medication may interfere with certain lab tests, possibly||
2057|178|I|causing false test results. Make sure lab personnel and all your||
2057|179|I|doctors know you use this drug.||
2057|180|B|||
2057|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2057|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2057|183|O|poison control center right away. US residents can call||
2057|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2057|185|O|Symptoms of overdose may include: severe mental/mood changes,||
2057|186|O|severe drowsiness, loss of consciousness, slowed breathing.||
2057|187|B|||
2057|188|N|NOTES:  Do not share this medication with others.||
2057|189|N|   Lab and/or medical tests (such as phenytoin blood levels,||
2057|190|N|liver function, complete blood count) should be done while you||
2057|191|N|are taking this medication. Keep all medical and lab||
2057|192|N|appointments. Consult your doctor for more details.||
2057|193|N|   Do not change from one brand of this product to another, or to||
2057|194|N|another dose form of this drug (such as capsules) without||
2057|195|N|consulting your doctor or pharmacist. Your dosage may have to be||
2057|196|N|adjusted.||
2057|197|B|||
2057|198|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2057|199|D|remember. If it is within 4 hours of the next dose, skip the||
2057|200|D|missed dose. Take your next dose at the regular time. Do not||
2057|201|D|double the dose to catch up. Check with your doctor if you miss||
2057|202|D|doses for more than 2 days in a row.||
2057|203|B|||
2057|204|R|STORAGE:  Store at room temperature away from light and moisture.||
2057|205|R|Do not store in the bathroom. Keep all medications away from||
2057|206|R|children and pets.||
2057|207|R|   Do not flush medications down the toilet or pour them into a||
2057|208|R|drain unless instructed to do so. Properly discard this product||
2057|209|R|when it is expired or no longer needed. Consult your pharmacist||
2057|210|R|or local waste disposal company.||
2057|211|B|||
2057|212|M|MEDICAL ALERT:  Your condition can cause complications in a||
2057|213|M|medical emergency. For information about enrolling in MedicAlert,||
2057|214|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2057|215|B|||
2057|216|A|Information last revised October 2024.||
2057|217|A|Copyright(c) 2025 First Databank, Inc.||
2057|218|B|||
2058|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2058|002|Z|does NOT have all possible information about this product. This||
2058|003|Z|information does not assure that this product is safe, effective,||
2058|004|Z|or appropriate for you. This information is not individual||
2058|005|Z|medical advice and does not substitute for the advice of your||
2058|006|Z|health care professional. Always ask your health care||
2058|007|Z|professional for complete information about this product and your||
2058|008|Z|specific health needs.||
2058|009|B|||
2058|010|T|BREXANOLONE - INJECTION||
2058|011|F|(brex-AN-oh-lone)||
2058|012|B|||
2058|013|C|COMMON BRAND NAME(S): Zulresso||
2058|014|B|||
2058|015|W|WARNING:  This medication may cause you to feel very sleepy or to||
2058|016|W|suddenly pass out (lose consciousness). You might not even feel||
2058|017|W|drowsy first. Careful monitoring by your doctor may decrease your||
2058|018|W|risk. During treatment with this medication, tell your doctor||
2058|019|W|right away if you feel like you cannot stay awake during the time||
2058|020|W|you are normally awake, or if you feel like you are going to pass||
2058|021|W|out. Another caregiver must be with you to help care for your||
2058|022|W|child(ren) during this time. After your injection, do not drive,||
2058|023|W|use machinery, or do anything that needs alertness until you can||
2058|024|W|do it safely. Avoid alcoholic beverages. Talk to your doctor if||
2058|025|W|you are using marijuana (cannabis).||
2058|026|W|   To receive brexanolone in the United States, you must||
2058|027|W|understand, agree to, and carefully follow the requirements of||
2058|028|W|the REMS Program for this medication. If you live in Canada or||
2058|029|W|any other country, consult your doctor and pharmacist for your||
2058|030|W|country's regulations.||
2058|031|B|||
2058|032|U|USES:  This medication is used to treat a certain type of||
2058|033|U|depression (postpartum depression). Brexanolone is thought to||
2058|034|U|work by affecting the balance of certain natural substances in||
2058|035|U|the brain.||
2058|036|B|||
2058|037|H|HOW TO USE:  Read the Medication Guide provided by your||
2058|038|H|pharmacist before you start using brexanolone. If you have any||
2058|039|H|questions, ask your doctor or pharmacist.||
2058|040|H|   This medication is given by continuous injection into a vein||
2058|041|H|by a healthcare provider. The injection is given as directed by||
2058|042|H|your doctor, usually over 60 hours (2 and a half days). The||
2058|043|H|dosage is based on your medical condition and response to||
2058|044|H|treatment.||
2058|045|H|   Tell your doctor if your condition does not get better or if||
2058|046|H|it gets worse.||
2058|047|B|||
2058|048|S|SIDE EFFECTS:  See also Warning section.||
2058|049|S|   Dizziness, drowsiness, feeling of spinning, flushing, or dry||
2058|050|S|mouth may occur. If any of these effects last or get worse, tell||
2058|051|S|your doctor or pharmacist promptly.||
2058|052|S|   Remember that this medication has been prescribed because your||
2058|053|S|doctor has judged that the benefit to you is greater than the||
2058|054|S|risk of side effects. Many people using this medication do not||
2058|055|S|have serious side effects.||
2058|056|S|   Antidepressant medications are used to treat a variety of||
2058|057|S|conditions, including depression and other mental/mood disorders.||
2058|058|S|These medications can help prevent suicidal thoughts/attempts and||
2058|059|S|provide other important benefits. However, studies have shown||
2058|060|S|that a small number of people (especially people younger than 25)||
2058|061|S|who take antidepressants for any condition may experience||
2058|062|S|worsening depression, other mental/mood symptoms, or suicidal||
2058|063|S|thoughts/attempts. It is very important to talk with the doctor||
2058|064|S|about the risks and benefits of antidepressant medication||
2058|065|S|(especially for people younger than 25), even if treatment is not||
2058|066|S|for a mental/mood condition.||
2058|067|S|   Tell the doctor right away if you notice worsening||
2058|068|S|depression/other psychiatric conditions, unusual behavior changes||
2058|069|S|(including possible suicidal thoughts/attempts), or other||
2058|070|S|mental/mood changes (including new/worsening anxiety, panic||
2058|071|S|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2058|072|S|impulsive actions, severe restlessness, very rapid speech). Be||
2058|073|S|especially watchful for these symptoms when a new antidepressant||
2058|074|S|is started or when the dose is changed.||
2058|075|S|   A very serious allergic reaction to this drug is rare.||
2058|076|S|However, get medical help right away if you notice any symptoms||
2058|077|S|of a serious allergic reaction, including: rash, itching/swelling||
2058|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2058|079|S|breathing.||
2058|080|S|   This is not a complete list of possible side effects. If you||
2058|081|S|notice other effects not listed above, contact your doctor or||
2058|082|S|pharmacist.||
2058|083|S|   In the US -||
2058|084|S|   Call your doctor for medical advice about side effects. You||
2058|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2058|086|S|www.fda.gov/medwatch.||
2058|087|S|   In Canada - Call your doctor for medical advice about side||
2058|088|S|effects. You may report side effects to Health Canada at||
2058|089|S|1-866-234-2345.||
2058|090|B|||
2058|091|P|PRECAUTIONS:  Before using brexanolone, tell your doctor or||
2058|092|P|pharmacist if you are allergic to it; or if you have any other||
2058|093|P|allergies. This product may contain inactive ingredients, which||
2058|094|P|can cause allergic reactions or other problems. Talk to your||
2058|095|P|pharmacist for more details.||
2058|096|P|   Before using this medication, tell your doctor or pharmacist||
2058|097|P|your medical history, especially of: kidney problems.||
2058|098|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2058|099|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2058|100|P|machinery, or do anything that needs alertness until you can do||
2058|101|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2058|102|P|are using marijuana (cannabis).||
2058|103|P|   Before having surgery, tell your doctor or dentist about all||
2058|104|P|the products you use (including prescription drugs,||
2058|105|P|nonprescription drugs, and herbal products).||
2058|106|P|   During pregnancy, this medication should be used only when||
2058|107|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2058|108|P|benefits with your doctor.||
2058|109|P|   This medication passes into breast milk in small amounts.||
2058|110|P|Consult your doctor before breastfeeding.||
2058|111|B|||
2058|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2058|113|I|medications work or increase your risk for serious side effects.||
2058|114|I|This document does not contain all possible drug interactions.||
2058|115|I|Keep a list of all the products you use (including||
2058|116|I|prescription/nonprescription drugs and herbal products) and share||
2058|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
2058|118|I|the dosage of any medicines without your doctor's approval.||
2058|119|I|   Tell your doctor or pharmacist if you are using other products||
2058|120|I|that cause drowsiness such as opioid pain or cough relievers||
2058|121|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2058|122|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2058|123|I|zolpidem), muscle relaxants (such as carisoprodol,||
2058|124|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2058|125|I|diphenhydramine).||
2058|126|I|   Check the labels on all your medicines (such as allergy or||
2058|127|I|cough-and-cold products) because they may contain ingredients||
2058|128|I|that cause drowsiness. Ask your pharmacist about using those||
2058|129|I|products safely.||
2058|130|B|||
2058|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2058|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2058|133|O|poison control center right away. US residents can call||
2058|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2058|135|B|||
2058|136|N|NOTES:  Do not share this medication with others. Sharing it is||
2058|137|N|against the law.||
2058|138|N|   Lab and/or medical tests (such as blood oxygen levels) should||
2058|139|N|be done while you are using this medication. Keep all medical and||
2058|140|N|lab appointments.||
2058|141|B|||
2058|142|D|MISSED DOSE:  Not applicable.||
2058|143|B|||
2058|144|R|STORAGE:  Not applicable. This medication is given in a hospital||
2058|145|R|or clinic and will not be stored at home.||
2058|146|B|||
2058|147|A|Information last revised May 2024.||
2058|148|A|Copyright(c) 2025 First Databank, Inc.||
2058|149|B|||
2059|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2059|002|Z|does NOT have all possible information about this product. This||
2059|003|Z|information does not assure that this product is safe, effective,||
2059|004|Z|or appropriate for you. This information is not individual||
2059|005|Z|medical advice and does not substitute for the advice of your||
2059|006|Z|health care professional. Always ask your health care||
2059|007|Z|professional for complete information about this product and your||
2059|008|Z|specific health needs.||
2059|009|B|||
2059|010|T|CLONIDINE - EPIDURAL||
2059|011|F|(KLON-i-deen)||
2059|012|B|||
2059|013|C|COMMON BRAND NAME(S): Duraclon||
2059|014|B|||
2059|015|U|USES:  Clonidine is used with another medication (an opioid) to||
2059|016|U|treat severe pain in people with cancer. Clonidine belongs to a||
2059|017|U|class of drugs known as central alpha agonists. It works by||
2059|018|U|blocking the nerves in the spinal cord that send pain signals.||
2059|019|B|||
2059|020|H|HOW TO USE:  This medication is given by injection into the area||
2059|021|H|around the spinal cord (epidural) by a health care professional.||
2059|022|H|It is given continuously using a small pump as directed by your||
2059|023|H|doctor.||
2059|024|H|   The dosage is based on your medical condition and response to||
2059|025|H|treatment.||
2059|026|H|   Do not stop using this medication without consulting your||
2059|027|H|doctor. You may experience symptoms such as headache, fast||
2059|028|H|heartbeat, nausea, anxiety, and flushing. A rapid rise in blood||
2059|029|H|pressure may also occur when the drug is suddenly stopped. The||
2059|030|H|risk is greater if you have used this drug for a long time or in||
2059|031|H|high doses, or if you are also taking a beta blocker (such as||
2059|032|H|atenolol). There have also been rare reports of severe, possibly||
2059|033|H|fatal reactions (such as stroke) from stopping this drug too||
2059|034|H|quickly, so it is important that you do not run out of clonidine.||
2059|035|H|Tell your doctor right away if your infusion is interrupted or if||
2059|036|H|you have any problems with your pump. To prevent any reactions||
2059|037|H|while you are stopping treatment with this drug, your doctor may||
2059|038|H|reduce your dose gradually. Consult your doctor or pharmacist for||
2059|039|H|more details. Report any new or worsening symptoms right away.||
2059|040|H|   To prevent infection, learn how to handle the infusion pump||
2059|041|H|and learn proper care of the injection site. Tell your doctor||
2059|042|H|right away if there are any signs of infection around the||
2059|043|H|injection site (such as swelling, redness, tenderness). See also||
2059|044|H|Side Effects section.||
2059|045|H|   Tell your doctor if your pain does not get better or if it||
2059|046|H|gets worse.||
2059|047|B|||
2059|048|S|SIDE EFFECTS:  See also How to Use section.||
2059|049|S|   Dizziness, lightheadedness, drowsiness, tiredness, nausea, or||
2059|050|S|dry mouth may occur. If any of these effects last or get worse,||
2059|051|S|tell your doctor or pharmacist promptly.||
2059|052|S|   To reduce the risk of dizziness and lightheadedness, get up||
2059|053|S|slowly when rising from a sitting or lying position.||
2059|054|S|   Remember that this medication has been prescribed because your||
2059|055|S|doctor has judged that the benefit to you is greater than the||
2059|056|S|risk of side effects. Many people using this medication do not||
2059|057|S|have serious side effects.||
2059|058|S|   Tell your doctor right away if you have any serious side||
2059|059|S|effects, including: fainting, slow/irregular heartbeat,||
2059|060|S|mental/mood changes (such as irritability, depression).||
2059|061|S|   A very serious brain infection (meningitis) may occur if the||
2059|062|S|site of your infusion or the solution going into your spinal cord||
2059|063|S|becomes contaminated. Get medical help right away if you notice||
2059|064|S|any symptoms of meningitis such as a headache that is severe or||
2059|065|S|doesn't go away, fever, stiff/painful neck, confusion, or||
2059|066|S|seizures.||
2059|067|S|   A very serious allergic reaction to this drug is rare.||
2059|068|S|However, get medical help right away if you notice any symptoms||
2059|069|S|of a serious allergic reaction, including: rash, itching/swelling||
2059|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2059|071|S|breathing.||
2059|072|S|   This is not a complete list of possible side effects. If you||
2059|073|S|notice other effects not listed above, contact your doctor or||
2059|074|S|pharmacist.||
2059|075|S|   In the US -||
2059|076|S|   Call your doctor for medical advice about side effects. You||
2059|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2059|078|S|www.fda.gov/medwatch.||
2059|079|S|   In Canada - Call your doctor for medical advice about side||
2059|080|S|effects. You may report side effects to Health Canada at||
2059|081|S|1-866-234-2345.||
2059|082|B|||
2059|083|P|PRECAUTIONS:  Before using clonidine, tell your doctor or||
2059|084|P|pharmacist if you are allergic to it (including having a rash||
2059|085|P|while using clonidine patches); or if you have any other||
2059|086|P|allergies. This product may contain inactive ingredients, which||
2059|087|P|can cause allergic reactions or other problems. Talk to your||
2059|088|P|pharmacist for more details.||
2059|089|P|   Before using this medication, tell your doctor or pharmacist||
2059|090|P|your medical history, especially of: heart rhythm problems (such||
2059|091|P|as slow/irregular heartbeat), stroke, high or low blood pressure,||
2059|092|P|kidney disease, bleeding problems, blood disorders, infection of||
2059|093|P|the spinal cord.||
2059|094|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2059|095|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2059|096|P|machinery, or do anything that needs alertness until you can do||
2059|097|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2059|098|P|are using marijuana (cannabis).||
2059|099|P|   Before having surgery, tell your doctor or dentist about all||
2059|100|P|the products you use (including prescription drugs,||
2059|101|P|nonprescription drugs, and herbal products).||
2059|102|P|   Older adults may be more sensitive to the side effects of this||
2059|103|P|product, especially dizziness or drowsiness. These side effects||
2059|104|P|may increase the risk of falling.||
2059|105|P|   During pregnancy, this medication should be used only when||
2059|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
2059|107|P|   This drug passes into breast milk and may have undesirable||
2059|108|P|effects on a nursing infant. Consult your doctor before||
2059|109|P|breastfeeding.||
2059|110|B|||
2059|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2059|112|I|medications work or increase your risk for serious side effects.||
2059|113|I|This document does not contain all possible drug interactions.||
2059|114|I|Keep a list of all the products you use (including||
2059|115|I|prescription/nonprescription drugs and herbal products) and share||
2059|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
2059|117|I|the dosage of any medicines without your doctor's approval.||
2059|118|I|   Tell your doctor or pharmacist if you are taking other||
2059|119|I|products that cause drowsiness such as opioid pain or cough||
2059|120|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2059|121|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2059|122|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2059|123|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2059|124|I|diphenhydramine).||
2059|125|I|   Check the labels on all your medicines (such as allergy or||
2059|126|I|cough-and-cold products) because they may contain ingredients||
2059|127|I|that cause drowsiness. Ask your pharmacist about using those||
2059|128|I|products safely.||
2059|129|B|||
2059|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2059|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2059|132|O|poison control center right away. US residents can call||
2059|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2059|134|O|Symptoms of overdose may include: high blood pressure, severe||
2059|135|O|dizziness/drowsiness, fainting, slow/irregular heartbeat,||
2059|136|O|slow/shallow breathing.||
2059|137|B|||
2059|138|N|NOTES:  Do not share this medication with others.||
2059|139|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
2059|140|N|should be done while you are using this medication. Consult your||
2059|141|N|doctor for more details.||
2059|142|B|||
2059|143|D|MISSED DOSE:  This drug is to be given continuously as an||
2059|144|D|infusion. If your infusion is interrupted, contact your doctor or||
2059|145|D|pharmacist right away.||
2059|146|B|||
2059|147|R|STORAGE:  Not applicable. This medication is given in a hospital||
2059|148|R|or clinic and will not be stored at home.||
2059|149|B|||
2059|150|A|Information last revised May 2024.||
2059|151|A|Copyright(c) 2025 First Databank, Inc.||
2059|152|B|||
2060|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2060|002|Z|does NOT have all possible information about this product. This||
2060|003|Z|information does not assure that this product is safe, effective,||
2060|004|Z|or appropriate for you. This information is not individual||
2060|005|Z|medical advice and does not substitute for the advice of your||
2060|006|Z|health care professional. Always ask your health care||
2060|007|Z|professional for complete information about this product and your||
2060|008|Z|specific health needs.||
2060|009|B|||
2060|010|T|AMPHETAMINE DISINTEGRATING TABLET - ORAL||
2060|011|F|(am-FET-a-meen)||
2060|012|B|||
2060|013|C|COMMON BRAND NAME(S): Evekeo ODT||
2060|014|B|||
2060|015|W|WARNING:  Misuse or abuse of amphetamines may cause serious||
2060|016|W|(possibly fatal) heart and blood pressure problems.||
2060|017|W|Amphetamine-type medications can be habit-forming. Use only as||
2060|018|W|directed. If you use this drug for a long time, you may become||
2060|019|W|dependent on it and may have withdrawal symptoms after stopping||
2060|020|W|the drug. Consult your doctor or pharmacist for more details.||
2060|021|W|(See also How to Use section.)||
2060|022|B|||
2060|023|U|USES:  This medication is used to treat attention deficit||
2060|024|U|hyperactivity disorder - ADHD. It works by changing the amounts||
2060|025|U|of certain natural substances in the brain. Amphetamine belongs||
2060|026|U|to a class of drugs known as stimulants. It can help increase||
2060|027|U|your ability to pay attention, stay focused on an activity, and||
2060|028|U|control behavior problems. It may also help you to organize your||
2060|029|U|tasks and improve listening skills.||
2060|030|B|||
2060|031|H|HOW TO USE:  Read the Medication Guide provided by your||
2060|032|H|pharmacist before you start taking amphetamine and each time you||
2060|033|H|get a refill. If you have any questions, ask your doctor or||
2060|034|H|pharmacist.||
2060|035|H|   Take this medication by mouth with or without food as directed||
2060|036|H|by your doctor, usually 1 to 3 times a day. The first dose is||
2060|037|H|usually taken when you wake up in the morning. If more doses are||
2060|038|H|prescribed, take them as directed by your doctor, usually 4 to 6||
2060|039|H|hours apart.||
2060|040|H|   Keep the medication in the original package until you are||
2060|041|H|ready to take a dose. Dry your hands before handling the||
2060|042|H|medication. To remove a tablet, push the tablet through the foil||
2060|043|H|of the blister pack. Place the tablet on your tongue, allow it to||
2060|044|H|dissolve, and swallow with your saliva. You do not need to take||
2060|045|H|this medication with water or other liquid. Do not crush or chew||
2060|046|H|the tablet.||
2060|047|H|   The dosage is based on your medical condition, age, and||
2060|048|H|response to treatment. Your doctor may adjust your dose to find||
2060|049|H|the dose that is best for you. Follow your doctor's instructions||
2060|050|H|carefully.||
2060|051|H|   Use this medication regularly to get the most benefit from it.||
2060|052|H|To help you remember, take it at the same time(s) each day.||
2060|053|H|   During treatment, your doctor may sometimes stop the||
2060|054|H|medication for a short time to see if the medication is still||
2060|055|H|needed.||
2060|056|H|   If you suddenly stop using this medication, you may have||
2060|057|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
2060|058|H|agitation). To help prevent withdrawal, your doctor may lower||
2060|059|H|your dose slowly. Withdrawal is more likely if you have used||
2060|060|H|amphetamine for a long time or in high doses. Tell your doctor or||
2060|061|H|pharmacist right away if you have withdrawal.||
2060|062|H|   When this medication is used for a long time, it may not work||
2060|063|H|as well. Talk with your doctor if this medication stops working||
2060|064|H|well.||
2060|065|H|   Though it helps many people, this medication may sometimes||
2060|066|H|cause addiction. This risk may be higher if you have a substance||
2060|067|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2060|068|H|Take this medication exactly as prescribed to lower the risk of||
2060|069|H|addiction. Ask your doctor or pharmacist for more details.||
2060|070|H|   Tell your doctor if your condition does not get better or if||
2060|071|H|it gets worse.||
2060|072|B|||
2060|073|S|SIDE EFFECTS:  Loss of appetite, weight loss, dry mouth, stomach||
2060|074|S|upset/pain, nausea/vomiting, dizziness, headache, fever, and||
2060|075|S|trouble sleeping may occur. If any of these effects last or get||
2060|076|S|worse, tell your doctor or pharmacist promptly.||
2060|077|S|   Remember that this medication has been prescribed because your||
2060|078|S|doctor has judged that the benefit to you is greater than the||
2060|079|S|risk of side effects. Many people using this medication do not||
2060|080|S|have serious side effects.||
2060|081|S|   This medication may raise your blood pressure. Check your||
2060|082|S|blood pressure regularly and tell your doctor if the results are||
2060|083|S|high.||
2060|084|S|   Tell your doctor right away if you have any serious side||
2060|085|S|effects, including: signs of blood flow problems in the fingers||
2060|086|S|or toes (such as coldness, numbness, pain, or skin color||
2060|087|S|changes), unusual wounds on the fingers or toes,||
2060|088|S|mental/mood/behavior changes (such as agitation, mood swings,||
2060|089|S|depression, abnormal thoughts, thoughts of suicide), uncontrolled||
2060|090|S|movements, outbursts of words/sounds, change in sexual||
2060|091|S|ability/desire, swelling ankles/feet, extreme tiredness, blurred||
2060|092|S|vision, frequent/prolonged erections (in males).||
2060|093|S|   Get medical help right away if you have any very serious side||
2060|094|S|effects, including: fainting, severe headache,||
2060|095|S|fast/pounding/irregular heartbeat, seizures, symptoms of a stroke||
2060|096|S|(such as weakness on one side of the body, trouble speaking,||
2060|097|S|sudden vision changes, confusion), symptoms of a heart attack||
2060|098|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
2060|099|S|sweating).||
2060|100|S|   This medication may increase serotonin and rarely cause a very||
2060|101|S|serious condition called serotonin syndrome/toxicity. The risk||
2060|102|S|increases if you are also taking other drugs that increase||
2060|103|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2060|104|S|take (see Drug Interactions section). Get medical help right away||
2060|105|S|if you develop some of the following symptoms: fast heartbeat,||
2060|106|S|hallucinations, loss of coordination, severe dizziness, severe||
2060|107|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2060|108|S|unusual agitation/restlessness.||
2060|109|S|   A very serious allergic reaction to this drug is rare.||
2060|110|S|However, get medical help right away if you notice any symptoms||
2060|111|S|of a serious allergic reaction, including: rash, itching/swelling||
2060|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2060|113|S|breathing.||
2060|114|S|   This is not a complete list of possible side effects. If you||
2060|115|S|notice other effects not listed above, contact your doctor or||
2060|116|S|pharmacist.||
2060|117|S|   In the US -||
2060|118|S|   Call your doctor for medical advice about side effects. You||
2060|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2060|120|S|www.fda.gov/medwatch.||
2060|121|S|   In Canada - Call your doctor for medical advice about side||
2060|122|S|effects. You may report side effects to Health Canada at||
2060|123|S|1-866-234-2345.||
2060|124|B|||
2060|125|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2060|126|P|pharmacist if you are allergic to it; or to other sympathomimetic||
2060|127|P|drugs (such as lisdexamfetamine, dextroamphetamine); or if you||
2060|128|P|have any other allergies. This product may contain inactive||
2060|129|P|ingredients, which can cause allergic reactions or other||
2060|130|P|problems. Talk to your pharmacist for more details.||
2060|131|P|   Before using this medication, tell your doctor or pharmacist||
2060|132|P|your medical history, especially of: blood circulation problems||
2060|133|P|(such as Raynaud's syndrome), personal/family history of||
2060|134|P|mental/mood disorders (such as bipolar disorder, depression,||
2060|135|P|psychotic disorder, suicidal thoughts), heart problems (including||
2060|136|P|irregular heartbeat/rhythm, coronary artery disease, heart||
2060|137|P|failure, cardiomyopathy, problems with the heart structure such||
2060|138|P|as valve problems), family history of heart problems (such as||
2060|139|P|sudden death/irregular heartbeat/rhythm), stroke, high blood||
2060|140|P|pressure, overactive thyroid (hyperthyroidism), glaucoma,||
2060|141|P|seizures, personal or family history of a substance use disorder||
2060|142|P|(such as overuse of or addiction to drugs/alcohol), personal or||
2060|143|P|family history of uncontrolled muscle movements (such as Tourette||
2060|144|P|syndrome).||
2060|145|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2060|146|P|can make you more dizzy. Do not drive, use machinery, or do||
2060|147|P|anything that needs alertness until you can do it safely. Limit||
2060|148|P|alcoholic beverages. Talk to your doctor if you are using||
2060|149|P|marijuana (cannabis).||
2060|150|P|   Before having surgery, tell your doctor or dentist about all||
2060|151|P|the products you use (including prescription drugs,||
2060|152|P|nonprescription drugs, and herbal products).||
2060|153|P|   Children may be more sensitive to the side effects of this||
2060|154|P|drug, especially weight loss. This medication may slow down a||
2060|155|P|child's growth. The doctor may recommend temporarily stopping the||
2060|156|P|medication from time to time to reduce this risk. Monitor your||
2060|157|P|child's weight and height. Consult the doctor or pharmacist for||
2060|158|P|more details.||
2060|159|P|   Older adults may be more sensitive to the side effects of this||
2060|160|P|drug, especially chest pain, trouble sleeping, or weight loss.||
2060|161|P|   During pregnancy, this medication should be used only when||
2060|162|P|clearly needed. Discuss the risks and benefits with your doctor.||
2060|163|P|Babies born to mothers who are dependent on this medication may||
2060|164|P|be born too soon (premature) and have low birth weight. They may||
2060|165|P|also have withdrawal symptoms. Tell your doctor right away if you||
2060|166|P|notice possible mood changes, agitation, or unusual tiredness in||
2060|167|P|your newborn.||
2060|168|P|   This medication passes into breast milk and may have||
2060|169|P|undesirable effects on a nursing infant. Breastfeeding is not||
2060|170|P|recommended while using this medication. Consult your doctor||
2060|171|P|before breastfeeding.||
2060|172|B|||
2060|173|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2060|174|I|medications work or increase your risk for serious side effects.||
2060|175|I|This document does not contain all possible drug interactions.||
2060|176|I|Keep a list of all the products you use (including||
2060|177|I|prescription/nonprescription drugs and herbal products) and share||
2060|178|I|it with your doctor and pharmacist. Do not start, stop, or change||
2060|179|I|the dosage of any medicines without your doctor's approval.||
2060|180|I|   Taking MAO inhibitors with this medication may cause a serious||
2060|181|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2060|182|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2060|183|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2060|184|I|selegiline, tranylcypromine) during treatment with this||
2060|185|I|medication. Most MAO inhibitors should also not be taken for two||
2060|186|I|weeks before treatment with this medication. Ask your doctor when||
2060|187|I|to start or stop taking this medication.||
2060|188|I|   Some products have ingredients that could raise your heart||
2060|189|I|rate or blood pressure. Tell your pharmacist what products you||
2060|190|I|are using, and ask how to use them safely (especially||
2060|191|I|cough-and-cold products, diet aids, or NSAIDs such as||
2060|192|I|ibuprofen/naproxen).||
2060|193|I|   The risk of serotonin syndrome/toxicity increases if you are||
2060|194|I|also taking other drugs that increase serotonin. Examples include||
2060|195|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
2060|196|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2060|197|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2060|198|I|serotonin syndrome/toxicity may be more likely when you start or||
2060|199|I|increase the dose of these drugs.||
2060|200|I|   Amphetamine is very similar to dextroamphetamine or||
2060|201|I|lisdexamfetamine. Do not use medications containing||
2060|202|I|dextroamphetamine or lisdexamfetamine while using amphetamine.||
2060|203|I|   This medication may interfere with certain lab tests (such as||
2060|204|I|blood and urine steroid levels, brain scan for Parkinson's||
2060|205|I|disease), possibly causing false test results. Make sure lab||
2060|206|I|personnel and all your doctors know you use this drug.||
2060|207|B|||
2060|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2060|209|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2060|210|O|poison control center right away. US residents can call||
2060|211|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2060|212|O|Symptoms of overdose may include: severe mental/mood changes||
2060|213|O|(such as restlessness, confusion), seizures, fast breathing.||
2060|214|B|||
2060|215|N|NOTES:  Do not share this medication with others. Sharing it is||
2060|216|N|against the law.||
2060|217|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
2060|218|N|growth checks in children) may be done while you are taking this||
2060|219|N|medication. Keep all medical and lab appointments.||
2060|220|B|||
2060|221|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2060|222|D|remember. If it is late in the afternoon or near the time of the||
2060|223|D|next dose, skip the missed dose. Take your next dose at the||
2060|224|D|regular time. Do not double the dose to catch up.||
2060|225|B|||
2060|226|R|STORAGE:  Store at room temperature away from light and moisture.||
2060|227|R|Do not store in the bathroom. Keep all medications away from||
2060|228|R|children and pets.||
2060|229|R|   Do not flush medications down the toilet or pour them into a||
2060|230|R|drain unless instructed to do so. Properly discard this product||
2060|231|R|when it is expired or no longer needed. Consult your pharmacist||
2060|232|R|or local waste disposal company.||
2060|233|B|||
2060|234|A|Information last revised May 2024.||
2060|235|A|Copyright(c) 2025 First Databank, Inc.||
2060|236|B|||
2061|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2061|002|Z|does NOT have all possible information about this product. This||
2061|003|Z|information does not assure that this product is safe, effective,||
2061|004|Z|or appropriate for you. This information is not individual||
2061|005|Z|medical advice and does not substitute for the advice of your||
2061|006|Z|health care professional. Always ask your health care||
2061|007|Z|professional for complete information about this product and your||
2061|008|Z|specific health needs.||
2061|009|B|||
2061|010|T|REPAGLINIDE - ORAL||
2061|011|F|(reh-PAGG-lin-ide)||
2061|012|B|||
2061|013|C|COMMON BRAND NAME(S): Prandin||
2061|014|B|||
2061|015|U|USES:  Repaglinide is used alone or with other medications to||
2061|016|U|control high blood sugar along with a proper diet and exercise||
2061|017|U|program. It is used in people with type 2 diabetes. Controlling||
2061|018|U|high blood sugar helps prevent kidney damage, blindness, nerve||
2061|019|U|problems, loss of limbs, and sexual function problems. Proper||
2061|020|U|control of diabetes may also lessen your risk of a heart attack||
2061|021|U|or stroke. It works by stimulating the body to produce more||
2061|022|U|insulin. Insulin is a natural substance that allows the body to||
2061|023|U|properly use sugar from the diet.||
2061|024|B|||
2061|025|H|HOW TO USE:  Read the Patient Information leaflet if one is||
2061|026|H|available from your pharmacist before you start using repaglinide||
2061|027|H|and each time you get a refill. If you have any questions,||
2061|028|H|consult your doctor or pharmacist.||
2061|029|H|   Take this medication by mouth within 30 minutes before each||
2061|030|H|meal as directed by your doctor, usually 2-4 times daily||
2061|031|H|depending on the number of meals. Do not take a dose of||
2061|032|H|medication if you are skipping that meal or if your blood sugar||
2061|033|H|is low.||
2061|034|H|   The dosage is based on your medical condition, response to||
2061|035|H|treatment, and other medications you may be taking. Be sure to||
2061|036|H|tell your doctor and pharmacist about all the products you use||
2061|037|H|(including prescription drugs, nonprescription drugs, and herbal||
2061|038|H|products).||
2061|039|H|   Use this medication regularly as directed by your doctor in||
2061|040|H|order to get the most benefit from it. Carefully follow the||
2061|041|H|medication treatment plan, meal plan, and exercise program your||
2061|042|H|doctor has recommended.||
2061|043|H|   Tell your doctor if your condition does not get better or if||
2061|044|H|it gets worse (your blood sugar is too high or too low).||
2061|045|B|||
2061|046|S|SIDE EFFECTS:  Weight gain, diarrhea, and joint pain may occur.||
2061|047|S|If any of these effects last or get worse, notify your doctor or||
2061|048|S|pharmacist promptly.||
2061|049|S|   Remember that this medication has been prescribed because your||
2061|050|S|doctor has judged that the benefit to you is greater than the||
2061|051|S|risk of side effects. Many people using this medication do not||
2061|052|S|have serious side effects.||
2061|053|S|   Repaglinide can cause low blood sugar (hypoglycemia). This may||
2061|054|S|occur if you do not get enough calories from food or if you do||
2061|055|S|unusually heavy exercise. Symptoms of low blood sugar include||
2061|056|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
2061|057|S|dizziness, or tingling hands/feet. It is a good habit to carry||
2061|058|S|glucose tablets or gel to treat low blood sugar. If you don't||
2061|059|S|have these reliable forms of glucose, rapidly raise your blood||
2061|060|S|sugar by eating a quick source of sugar such as table sugar,||
2061|061|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
2061|062|S|doctor right away about the reaction and the use of this product.||
2061|063|S|To help prevent low blood sugar, eat meals on a regular schedule,||
2061|064|S|and do not skip meals. Check with your doctor or pharmacist to||
2061|065|S|find out what you should do if you miss a meal.||
2061|066|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
2061|067|S|thirst/urination. If these symptoms occur, tell your doctor right||
2061|068|S|away. Your doctor may need to adjust your diabetes medication,||
2061|069|S|exercise program, or diet.||
2061|070|S|   A very serious allergic reaction to this drug is rare.||
2061|071|S|However, get medical help right away if you notice any symptoms||
2061|072|S|of a serious allergic reaction, including: rash, itching/swelling||
2061|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2061|074|S|breathing.||
2061|075|S|   This is not a complete list of possible side effects. If you||
2061|076|S|notice other effects not listed above, contact your doctor or||
2061|077|S|pharmacist.||
2061|078|S|   In the US -||
2061|079|S|   Call your doctor for medical advice about side effects. You||
2061|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2061|081|S|www.fda.gov/medwatch.||
2061|082|S|   In Canada - Call your doctor for medical advice about side||
2061|083|S|effects. You may report side effects to Health Canada at||
2061|084|S|1-866-234-2345.||
2061|085|B|||
2061|086|P|PRECAUTIONS:  Before taking repaglinide, tell your doctor or||
2061|087|P|pharmacist if you are allergic to it; or if you have any other||
2061|088|P|allergies. This product may contain inactive ingredients, which||
2061|089|P|can cause allergic reactions or other problems. Talk to your||
2061|090|P|pharmacist for more details.||
2061|091|P|   Before using this medication, tell your doctor or pharmacist||
2061|092|P|your medical history, especially of: kidney disease, liver||
2061|093|P|disease.||
2061|094|P|   You may experience blurred vision, dizziness, or drowsiness||
2061|095|P|due to extremely low or high blood sugar. Do not drive, use||
2061|096|P|machinery, or do anything that needs alertness or clear vision||
2061|097|P|until you can do it safely.||
2061|098|P|   Limit alcohol while taking this medication because it can||
2061|099|P|increase the risk of developing low blood sugar.||
2061|100|P|   During times of stress, such as fever, infection, injury, or||
2061|101|P|surgery, it may be more difficult to control your blood sugar.||
2061|102|P|Consult your doctor because increased stress may require a change||
2061|103|P|in your treatment plan, medications, or blood sugar testing.||
2061|104|P|   During pregnancy, this medication should be used only when||
2061|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
2061|106|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
2061|107|P|your doctor for managing your blood sugar while pregnant. Your||
2061|108|P|doctor may change your diabetes treatment during your pregnancy||
2061|109|P|(such as diet and medications including insulin).||
2061|110|P|   It is unknown if this drug passes into breast milk. Because of||
2061|111|P|possible risk to the infant, breastfeeding is not recommended||
2061|112|P|while using this drug. Consult your doctor before breastfeeding.||
2061|113|B|||
2061|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2061|115|I|medications work or increase your risk for serious side effects.||
2061|116|I|This document does not contain all possible drug interactions.||
2061|117|I|Keep a list of all the products you use (including||
2061|118|I|prescription/nonprescription drugs and herbal products) and share||
2061|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
2061|120|I|the dosage of any medicines without your doctor's approval.||
2061|121|I|   A product that may interact with this drug is: NPH insulin.||
2061|122|I|   Other medications can affect the removal of repaglinide from||
2061|123|I|your body, which may affect how repaglinide works. Examples||
2061|124|I|include clopidogrel, gemfibrozil, trimethoprim, azole antifungals||
2061|125|I|(such as itraconazole), macrolide antibiotics (such as||
2061|126|I|erythromycin), rifamycins (such as rifabutin), St. John's wort,||
2061|127|I|among others.||
2061|128|I|   Many drugs can affect your blood sugar, making it harder to||
2061|129|I|control. Examples include corticosteroids (such as prednisone),||
2061|130|I|psychiatric medicines (such as olanzapine), fluoroquinolone||
2061|131|I|antibiotics (such as ciprofloxacin), among others. Check your||
2061|132|I|blood sugar regularly as directed and share the results with your||
2061|133|I|doctor. Tell your doctor right away if you have symptoms of high||
2061|134|I|or low blood sugar. (See also Side Effects section.) Your doctor||
2061|135|I|may need to adjust your diabetes medication, exercise program, or||
2061|136|I|diet.||
2061|137|I|   Beta-blocker medications (such as metoprolol, propranolol,||
2061|138|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
2061|139|I|heartbeat you would usually feel when your blood sugar falls too||
2061|140|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
2061|141|I|dizziness, hunger, or sweating are unaffected by these drugs.||
2061|142|I|   Check the labels on all your medicines (such as cough-and-cold||
2061|143|I|products) carefully. Some products may contain sugar or alcohol||
2061|144|I|and may affect your blood sugar. Ask your doctor or pharmacist||
2061|145|I|about using these products safely.||
2061|146|I|   Other medications can affect the results of urine tests for||
2061|147|I|sugar or ketones. Consult your doctor or pharmacist for more||
2061|148|I|information.||
2061|149|B|||
2061|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2061|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2061|152|O|poison control center right away. US residents can call||
2061|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2061|154|O|Symptoms of overdose may include: very fast heartbeat, vision||
2061|155|O|changes, unexplained heavy sweating, agitation, fainting,||
2061|156|O|seizures.||
2061|157|B|||
2061|158|N|NOTES:  Do not share this medication with others.||
2061|159|N|   Attend a diabetes education program to learn more about how to||
2061|160|N|manage your diabetes with medications, diet, exercise, and||
2061|161|N|regular medical exams. Learn the symptoms of high and low blood||
2061|162|N|sugar and how to treat low blood sugar.||
2061|163|N|   Check your blood sugar regularly as directed and share the||
2061|164|N|results with your doctor. Lab and/or medical tests (such as||
2061|165|N|kidney function, fasting blood glucose, hemoglobin A1c) should be||
2061|166|N|done while you are taking this medication. Keep all medical and||
2061|167|N|lab appointments.||
2061|168|B|||
2061|169|D|MISSED DOSE:  If you miss a dose, skip that dose. Take your next||
2061|170|D|dose with your next meal. Do not double the dose to catch up.||
2061|171|B|||
2061|172|R|STORAGE:  Store at room temperature away from light and moisture.||
2061|173|R|Do not store in the bathroom. Keep all medications away from||
2061|174|R|children and pets.||
2061|175|R|   Do not flush medications down the toilet or pour them into a||
2061|176|R|drain unless instructed to do so. Properly discard this product||
2061|177|R|when it is expired or no longer needed. Consult your pharmacist||
2061|178|R|or local waste disposal company.||
2061|179|B|||
2061|180|M|MEDICAL ALERT:  Your condition can cause complications in a||
2061|181|M|medical emergency. For information about enrolling in MedicAlert,||
2061|182|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2061|183|B|||
2061|184|A|Information last revised November 2025.||
2061|185|A|Copyright(c) 2025 First Databank, Inc.||
2061|186|B|||
2062|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2062|002|Z|does NOT have all possible information about this product. This||
2062|003|Z|information does not assure that this product is safe, effective,||
2062|004|Z|or appropriate for you. This information is not individual||
2062|005|Z|medical advice and does not substitute for the advice of your||
2062|006|Z|health care professional. Always ask your health care||
2062|007|Z|professional for complete information about this product and your||
2062|008|Z|specific health needs.||
2062|009|B|||
2062|010|T|SOLRIAMFETOL - ORAL||
2062|011|F|(SOL-ri-AM-fe-tol)||
2062|012|B|||
2062|013|C|COMMON BRAND NAME(S): Sunosi||
2062|014|B|||
2062|015|U|USES:  This medication is used to improve wakefulness in people||
2062|016|U|that have too much daytime sleepiness due to certain sleep||
2062|017|U|problems (narcolepsy, obstructive sleep apnea). It may work by||
2062|018|U|changing the amounts of certain substances (dopamine,||
2062|019|U|norepinephrine) in your body.||
2062|020|U|   This medication is not used to treat the cause of obstructive||
2062|021|U|sleep apnea-OSA. Continue treatment for OSA, such as using||
2062|022|U|continuous positive airway pressure (CPAP), while using this||
2062|023|U|medication.||
2062|024|B|||
2062|025|H|HOW TO USE:  Read the Medication Guide provided by your||
2062|026|H|pharmacist before you start taking solriamfetol and each time you||
2062|027|H|get a refill. If you have any questions, ask your doctor or||
2062|028|H|pharmacist.||
2062|029|H|   Take this medication by mouth with or without food as directed||
2062|030|H|by your doctor, usually once daily when you first wake up. Avoid||
2062|031|H|taking this medication within 9 hours before you plan to go to||
2062|032|H|sleep. If you take it too close to your bedtime, you may find it||
2062|033|H|harder to sleep.||
2062|034|H|   The dosage is based on your medical condition and response to||
2062|035|H|treatment. To reduce your risk of side effects, your doctor may||
2062|036|H|direct you to start this medication at a low dose and gradually||
2062|037|H|increase your dose. Follow your doctor's instructions carefully.||
2062|038|H|   Use this medication regularly to get the most benefit from it.||
2062|039|H|To help you remember, take it at the same time each day.||
2062|040|H|   Do not increase your dose or use this drug more often or for||
2062|041|H|longer than prescribed. Your condition will not improve any||
2062|042|H|faster, and your risk of side effects will increase.||
2062|043|H|   Tell your doctor if your condition does not get better or if||
2062|044|H|it gets worse.||
2062|045|B|||
2062|046|S|SIDE EFFECTS:  Nausea, headache, decreased appetite, anxiety, or||
2062|047|S|trouble sleeping may occur. If any of these effects last or get||
2062|048|S|worse, tell your doctor or pharmacist promptly.||
2062|049|S|   Remember that this medication has been prescribed because your||
2062|050|S|doctor has judged that the benefit to you is greater than the||
2062|051|S|risk of side effects. Many people using this medication do not||
2062|052|S|have serious side effects.||
2062|053|S|   This medication may increase your blood pressure and heart||
2062|054|S|rate. Check your blood pressure and heart rate regularly and tell||
2062|055|S|your doctor if the results are high.||
2062|056|S|   Tell your doctor right away if you have any serious side||
2062|057|S|effects, including: mental/mood changes (such as irritability,||
2062|058|S|agitation, restlessness).||
2062|059|S|   A very serious allergic reaction to this drug is rare.||
2062|060|S|However, get medical help right away if you notice any symptoms||
2062|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2062|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2062|063|S|breathing.||
2062|064|S|   This is not a complete list of possible side effects. If you||
2062|065|S|notice other effects not listed above, contact your doctor or||
2062|066|S|pharmacist.||
2062|067|S|   In the US -||
2062|068|S|   Call your doctor for medical advice about side effects. You||
2062|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2062|070|S|www.fda.gov/medwatch.||
2062|071|S|   In Canada - Call your doctor for medical advice about side||
2062|072|S|effects. You may report side effects to Health Canada at||
2062|073|S|1-866-234-2345.||
2062|074|B|||
2062|075|P|PRECAUTIONS:  Before taking solriamfetol, tell your doctor or||
2062|076|P|pharmacist if you are allergic to it; or if you have any other||
2062|077|P|allergies. This product may contain inactive ingredients, which||
2062|078|P|can cause allergic reactions or other problems. Talk to your||
2062|079|P|pharmacist for more details.||
2062|080|P|   Before using this medication, tell your doctor or pharmacist||
2062|081|P|your medical history, especially of: kidney problems, high blood||
2062|082|P|pressure, heart problems (such as irregular heartbeat),||
2062|083|P|mental/mood problems (such as psychosis, bipolar disorder),||
2062|084|P|personal or family history of substance use disorder (such as||
2062|085|P|overuse of or addiction to drugs/alcohol).||
2062|086|P|   Before having surgery, tell your doctor or dentist about all||
2062|087|P|the products you use (including prescription drugs,||
2062|088|P|nonprescription drugs, and herbal products).||
2062|089|P|   During pregnancy, this medication should be used only when||
2062|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
2062|091|P|   This medication passes into breast milk. Consult your doctor||
2062|092|P|before breastfeeding.||
2062|093|B|||
2062|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2062|095|I|medications work or increase your risk for serious side effects.||
2062|096|I|This document does not contain all possible drug interactions.||
2062|097|I|Keep a list of all the products you use (including||
2062|098|I|prescription/nonprescription drugs and herbal products) and share||
2062|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2062|100|I|the dosage of any medicines without your doctor's approval.||
2062|101|I|   Taking MAO inhibitors with this medication may cause a serious||
2062|102|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
2062|103|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2062|104|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2062|105|I|selegiline, tranylcypromine) during treatment with this||
2062|106|I|medication. Most MAO inhibitors should also not be taken for two||
2062|107|I|weeks before treatment with this medication. Ask your doctor when||
2062|108|I|to start or stop taking this medication.||
2062|109|B|||
2062|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2062|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2062|112|O|poison control center right away. US residents can call||
2062|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2062|114|B|||
2062|115|N|NOTES:  Do not share this medication with others. Sharing it is||
2062|116|N|against the law.||
2062|117|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
2062|118|N|should be done while you are taking this medication. Keep all||
2062|119|N|medical and lab appointments.||
2062|120|B|||
2062|121|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2062|122|D|remember. If it is near the time of the next dose, skip the||
2062|123|D|missed dose. Take your next dose at the regular time. Do not||
2062|124|D|double the dose to catch up.||
2062|125|B|||
2062|126|R|STORAGE:  Store at room temperature away from light and moisture.||
2062|127|R|Do not store in the bathroom. Keep this medication in a safe||
2062|128|R|place to prevent theft, misuse, or abuse. Keep all medications||
2062|129|R|away from children and pets.||
2062|130|R|   Do not flush medications down the toilet or pour them into a||
2062|131|R|drain unless instructed to do so. Properly discard this product||
2062|132|R|when it is expired or no longer needed. Consult your pharmacist||
2062|133|R|or local waste disposal company.||
2062|134|B|||
2062|135|A|Information last revised May 2024.||
2062|136|A|Copyright(c) 2025 First Databank, Inc.||
2062|137|B|||
2063|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2063|002|Z|does NOT have all possible information about this product. This||
2063|003|Z|information does not assure that this product is safe, effective,||
2063|004|Z|or appropriate for you. This information is not individual||
2063|005|Z|medical advice and does not substitute for the advice of your||
2063|006|Z|health care professional. Always ask your health care||
2063|007|Z|professional for complete information about this product and your||
2063|008|Z|specific health needs.||
2063|009|B|||
2063|010|T|NITAZOXANIDE - ORAL||
2063|011|F|(NYE-ta-ZOX-a-nide)||
2063|012|B|||
2063|013|C|COMMON BRAND NAME(S): Alinia||
2063|014|B|||
2063|015|U|USES:  This medication is used to treat diarrhea caused by||
2063|016|U|certain parasite infections of the intestines (Cryptosporidium||
2063|017|U|parvum and Giardia lamblia).||
2063|018|B|||
2063|019|H|HOW TO USE:  Take this medication by mouth with food as directed||
2063|020|H|by your doctor, usually every 12 hours for 3 days.||
2063|021|H|   If you are taking the liquid form of this medication, shake||
2063|022|H|the bottle well before each dose. Carefully measure the dose||
2063|023|H|using a special measuring device/spoon. Do not use a household||
2063|024|H|spoon because you may not get the correct dose.||
2063|025|H|   Children 11 years old or younger should take the liquid form||
2063|026|H|of nitazoxanide, but not the tablets. Children's dosage is based||
2063|027|H|on age.||
2063|028|H|   Antibiotics work best when the amount of medicine in your body||
2063|029|H|is kept at a constant level. Take this drug at evenly spaced||
2063|030|H|intervals.||
2063|031|H|   Continue to take this medication for the full time prescribed,||
2063|032|H|even if symptoms disappear after a few doses. Stopping the||
2063|033|H|medication too early may result in a return of the infection.||
2063|034|H|   Tell your doctor if your condition lasts or gets worse.||
2063|035|B|||
2063|036|S|SIDE EFFECTS:  Headache, nausea, or stomach/abdominal pain may||
2063|037|S|occur. If any of these effects last or get worse, tell your||
2063|038|S|doctor or pharmacist promptly.||
2063|039|S|   Remember that this medication has been prescribed because your||
2063|040|S|doctor has judged that the benefit to you is greater than the||
2063|041|S|risk of side effects. Many people using this medication do not||
2063|042|S|have serious side effects.||
2063|043|S|   A very serious allergic reaction to this drug is rare.||
2063|044|S|However, get medical help right away if you notice any symptoms||
2063|045|S|of a serious allergic reaction, such as: rash, itching/swelling||
2063|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2063|047|S|breathing.||
2063|048|S|   This is not a complete list of possible side effects. If you||
2063|049|S|notice other effects not listed above, contact your doctor or||
2063|050|S|pharmacist.||
2063|051|S|   In the US -||
2063|052|S|   Call your doctor for medical advice about side effects. You||
2063|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2063|054|S|www.fda.gov/medwatch.||
2063|055|S|   In Canada - Call your doctor for medical advice about side||
2063|056|S|effects. You may report side effects to Health Canada at||
2063|057|S|1-866-234-2345.||
2063|058|B|||
2063|059|P|PRECAUTIONS:  Before taking nitazoxanide, tell your doctor or||
2063|060|P|pharmacist if you are allergic to it or if you have any other||
2063|061|P|allergies. This product may contain inactive ingredients, which||
2063|062|P|can cause allergic reactions or other problems. Talk to your||
2063|063|P|pharmacist for more details.||
2063|064|P|   Before using this medication, tell your doctor or pharmacist||
2063|065|P|your medical history, especially of: a weakened immune system||
2063|066|P|(such as HIV infection).||
2063|067|P|   The liquid form of this medication contains sugar. Caution is||
2063|068|P|advised if you have diabetes. Ask your doctor or pharmacist about||
2063|069|P|using this product safely.||
2063|070|P|   During pregnancy, this medication should be used only when||
2063|071|P|clearly needed. Discuss the risks and benefits with your doctor.||
2063|072|P|   It is unknown if this medication passes into breast milk.||
2063|073|P|Consult your doctor before breastfeeding.||
2063|074|B|||
2063|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2063|076|I|medications work or increase your risk for serious side effects.||
2063|077|I|This document does not contain all possible drug interactions.||
2063|078|I|Keep a list of all the products you use (such as||
2063|079|I|prescription/nonprescription drugs and herbal products) and share||
2063|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
2063|081|I|the dosage of any medicines without your doctor's approval.||
2063|082|B|||
2063|083|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2063|084|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2063|085|O|poison control center right away. US residents can call||
2063|086|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2063|087|B|||
2063|088|N|NOTES:  Do not share this medication with others.||
2063|089|N|   This medication has been prescribed for your current condition||
2063|090|N|only. Do not use it later for another infection unless your||
2063|091|N|doctor tells you to.||
2063|092|B|||
2063|093|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2063|094|D|remember. If it is near the time of the next dose, skip the||
2063|095|D|missed dose. Take your next dose at the regular time. Do not||
2063|096|D|double the dose to catch up.||
2063|097|B|||
2063|098|R|STORAGE:  Store at room temperature away from light and moisture.||
2063|099|R|Do not store in the bathroom. For the liquid form of this drug,||
2063|100|R|discard any unused medication after 7 days. Keep all medications||
2063|101|R|away from children and pets.||
2063|102|R|   Do not flush medications down the toilet or pour them into a||
2063|103|R|drain unless instructed to do so. Properly discard this product||
2063|104|R|when it is expired or no longer needed. Consult your pharmacist||
2063|105|R|or local waste disposal company.||
2063|106|B|||
2063|107|A|Information last revised August 2024.||
2063|108|A|Copyright(c) 2025 First Databank, Inc.||
2063|109|B|||
2064|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2064|002|Z|does NOT have all possible information about this product. This||
2064|003|Z|information does not assure that this product is safe, effective,||
2064|004|Z|or appropriate for you. This information is not individual||
2064|005|Z|medical advice and does not substitute for the advice of your||
2064|006|Z|health care professional. Always ask your health care||
2064|007|Z|professional for complete information about this product and your||
2064|008|Z|specific health needs.||
2064|009|B|||
2064|010|T|TIOPRONIN DELAYED-RELEASE - ORAL||
2064|011|F|(tye-OH-proe-nin)||
2064|012|B|||
2064|013|C|COMMON BRAND NAME(S): Thiola EC||
2064|014|B|||
2064|015|U|USES:  This medication is used to prevent kidney stones in people||
2064|016|U|with a certain inherited disorder (cystinuria). Cystinuria occurs||
2064|017|U|when there is too much of a certain natural substance (the amino||
2064|018|U|acid cystine) in the urine, leading to formation of kidney||
2064|019|U|stones. Tiopronin works by making cystine more dissolvable in the||
2064|020|U|urine.||
2064|021|U|   This medication should be used in combination with other||
2064|022|U|methods to prevent kidney stones (such as drinking plenty of||
2064|023|U|water, taking alkali treatment, following a special diet).||
2064|024|B|||
2064|025|H|HOW TO USE:  Take this medication by mouth with or without food||
2064|026|H|as directed by your doctor, usually three times daily. You may||
2064|027|H|take this medication with or without food, but it is important to||
2064|028|H|choose one way and take this medication the same way with every||
2064|029|H|dose.||
2064|030|H|   If you have trouble swallowing the tablets whole, you may||
2064|031|H|crush the tablet and mix it with 1 tablespoonful of applesauce in||
2064|032|H|a container. Do not use other foods or liquids. Crush only one||
2064|033|H|tablet at a time. Mix well and take all of the mixture right||
2064|034|H|away. Then add water to the container, mix, and drink the rinse||
2064|035|H|water to make sure you get all of your dose. If you cannot take||
2064|036|H|the crushed tablet-applesauce mixture right away, it can be kept||
2064|037|H|in a refrigerator for up to 2 hours. Discard any mixture that has||
2064|038|H|not been given after 2 hours.||
2064|039|H|   Avoid drinking alcohol 2 hours before and 3 hours after taking||
2064|040|H|this medication. Drinking alcohol may increase the amount of this||
2064|041|H|medication in your body which may cause serious side effects.||
2064|042|H|   Continue to drink plenty of water and to take the alkali||
2064|043|H|medication as directed by your doctor. Closely follow the diet||
2064|044|H|recommended by your doctor.||
2064|045|H|   The dosage is based on your medical condition, lab tests, and||
2064|046|H|response to treatment. Children's dosage may be based on weight.||
2064|047|H|   Use this medication regularly to get the most benefit from it.||
2064|048|H|To help you remember, take it at the same times each day.||
2064|049|H|   Do not increase your dose or use this drug more often or for||
2064|050|H|longer than prescribed. Your condition will not improve any||
2064|051|H|faster, and your risk of side effects will increase.||
2064|052|H|   Tell your doctor if your condition gets worse.||
2064|053|B|||
2064|054|S|SIDE EFFECTS:  Nausea, diarrhea, or decreased sense of||
2064|055|S|taste/smell may occur. If any of these effects last or get worse,||
2064|056|S|tell your doctor or pharmacist promptly.||
2064|057|S|   Remember that this medication has been prescribed because your||
2064|058|S|doctor has judged that the benefit to you is greater than the||
2064|059|S|risk of side effects. Many people using this medication do not||
2064|060|S|have serious side effects.||
2064|061|S|   Tell your doctor right away if you have any serious side||
2064|062|S|effects, including: muscle/joint pain, swollen lymph nodes, loss||
2064|063|S|of appetite, tiredness, signs of kidney problems (such as change||
2064|064|S|in the amount of urine, painful urination, cloudy/bloody/frothy||
2064|065|S|urine), muscle weakness.||
2064|066|S|   A very serious allergic reaction to this drug is rare.||
2064|067|S|However, get medical help right away if you notice any symptoms||
2064|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2064|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2064|070|S|breathing.||
2064|071|S|   This is not a complete list of possible side effects. If you||
2064|072|S|notice other effects not listed above, contact your doctor or||
2064|073|S|pharmacist.||
2064|074|S|   In the US -||
2064|075|S|   Call your doctor for medical advice about side effects. You||
2064|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2064|077|S|www.fda.gov/medwatch.||
2064|078|S|   In Canada - Call your doctor for medical advice about side||
2064|079|S|effects. You may report side effects to Health Canada at||
2064|080|S|1-866-234-2345.||
2064|081|B|||
2064|082|P|PRECAUTIONS:  Before taking tiopronin, tell your doctor or||
2064|083|P|pharmacist if you are allergic to it; or if you have any other||
2064|084|P|allergies. This product may contain inactive ingredients, which||
2064|085|P|can cause allergic reactions or other problems. Talk to your||
2064|086|P|pharmacist for more details.||
2064|087|P|   Before using this medication, tell your doctor or pharmacist||
2064|088|P|your medical history, especially of: liver disease, kidney||
2064|089|P|disease.||
2064|090|P|   Before having surgery, tell your doctor or dentist about all||
2064|091|P|the products you use (including prescription drugs,||
2064|092|P|nonprescription drugs, and herbal products).||
2064|093|P|   During pregnancy, this medication should be used only when||
2064|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
2064|095|P|   It is unknown if this medication passes into breast milk.||
2064|096|P|Because of possible risk to the infant, breastfeeding is not||
2064|097|P|recommended while using this medication. Consult your doctor||
2064|098|P|before breastfeeding.||
2064|099|B|||
2064|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2064|101|I|medications work or increase your risk for serious side effects.||
2064|102|I|This document does not contain all possible drug interactions.||
2064|103|I|Keep a list of all the products you use (including||
2064|104|I|prescription/nonprescription drugs and herbal products) and share||
2064|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
2064|106|I|the dosage of any medicines without your doctor's approval.||
2064|107|B|||
2064|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2064|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2064|110|O|poison control center right away. US residents can call||
2064|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2064|112|B|||
2064|113|N|NOTES:  Do not share this medication with others.||
2064|114|N|   Lab and/or medical tests (such as urine cystine levels, urine||
2064|115|N|tests) should be done while you are taking this medication. Keep||
2064|116|N|all medical and lab appointments. Consult your doctor for more||
2064|117|N|details.||
2064|118|B|||
2064|119|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2064|120|D|remember. If it is near the time of the next dose, skip the||
2064|121|D|missed dose. Take your next dose at the regular time. Do not||
2064|122|D|double the dose to catch up.||
2064|123|B|||
2064|124|R|STORAGE:  Store at room temperature away from light and moisture.||
2064|125|R|Do not store in the bathroom. Keep all medications away from||
2064|126|R|children and pets.||
2064|127|R|   Do not flush medications down the toilet or pour them into a||
2064|128|R|drain unless instructed to do so. Properly discard this product||
2064|129|R|when it is expired or no longer needed. Consult your pharmacist||
2064|130|R|or local waste disposal company.||
2064|131|B|||
2064|132|A|Information last revised August 2024.||
2064|133|A|Copyright(c) 2025 First Databank, Inc.||
2064|134|B|||
2065|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2065|002|Z|does NOT have all possible information about this product. This||
2065|003|Z|information does not assure that this product is safe, effective,||
2065|004|Z|or appropriate for you. This information is not individual||
2065|005|Z|medical advice and does not substitute for the advice of your||
2065|006|Z|health care professional. Always ask your health care||
2065|007|Z|professional for complete information about this product and your||
2065|008|Z|specific health needs.||
2065|009|B|||
2065|010|T|DROSPIRENONE - ORAL||
2065|011|F|(droe-SPYE-re-none)||
2065|012|B|||
2065|013|C|COMMON BRAND NAME(S): Slynd||
2065|014|B|||
2065|015|U|USES:  This medication is used to prevent pregnancy. It contains||
2065|016|U|the hormone drospirenone (a progestin).||
2065|017|U|   Besides preventing pregnancy, birth control pills may make||
2065|018|U|your periods more regular, decrease blood loss and painful||
2065|019|U|periods, and decrease your risk of ovarian cysts.||
2065|020|U|   This drug does not protect against sexually transmitted||
2065|021|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
2065|022|U|an effective barrier method (latex or polyurethane condom/dental||
2065|023|U|dams) during sexual activity will help to decrease your risk of||
2065|024|U|infection.||
2065|025|B|||
2065|026|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
2065|027|H|your pharmacist before you start using this product and each time||
2065|028|H|you get a refill. The leaflet contains very important information||
2065|029|H|on when to take your pills and what to do if you miss a dose. If||
2065|030|H|you have any questions, ask your doctor or pharmacist.||
2065|031|H|   Take this medication by mouth as directed by your doctor,||
2065|032|H|usually once daily. Pick a time of day that is easy for you to||
2065|033|H|remember, and take your pill at the same time each day.||
2065|034|H|   Begin taking this medication on the first day of your||
2065|035|H|menstrual period. Keep taking one tablet every day. Do not skip||
2065|036|H|any doses. Pregnancy is more likely if you miss pills, start a||
2065|037|H|new pack late, or take your pill at a different time of the day||
2065|038|H|than usual.||
2065|039|H|   If you have vomiting or diarrhea within 3 to 4 hours after||
2065|040|H|taking your tablet, follow the directions in the Patient||
2065|041|H|Information Leaflet for what to do if you miss a dose. Vomiting||
2065|042|H|or diarrhea can prevent your birth control pills from working||
2065|043|H|well. If vomiting or diarrhea continues, use a backup birth||
2065|044|H|control method (such as condoms, spermicide) and check with your||
2065|045|H|doctor or pharmacist for more details.||
2065|046|H|   Taking this medication after your evening meal or at bedtime||
2065|047|H|may help if you have stomach upset or nausea with the medication.||
2065|048|H|You may choose to take this medication at another time of day||
2065|049|H|that is easier for you to remember. No matter what dosing||
2065|050|H|schedule you use, it is very important that you take this||
2065|051|H|medication at the same time each day, 24 hours apart.||
2065|052|H|   Your pill pack contains 24 pills with active medication. It||
2065|053|H|also contains 4 reminder pills with no medication. Take one||
2065|054|H|active pill (with hormones) once daily for 24 days in a row. Take||
2065|055|H|an inactive pill once daily for 4 days in a row after you have||
2065|056|H|taken the last active pill unless otherwise directed by your||
2065|057|H|doctor. After you have taken the last inactive tablet in the pack||
2065|058|H|or gone 4 days without taking an active tablet, start a new pack||
2065|059|H|the next day even if your period is continuing or if you do not||
2065|060|H|have your period. If you do not get your period, consult your||
2065|061|H|doctor.||
2065|062|H|   Ask your doctor or pharmacist for information about how to||
2065|063|H|switch from other forms of hormonal birth control (such as patch,||
2065|064|H|other birth control pills) to this product. If any information is||
2065|065|H|unclear, consult the Patient Information Leaflet or your doctor||
2065|066|H|or pharmacist.||
2065|067|B|||
2065|068|S|SIDE EFFECTS:  Nausea, vomiting, headache, bloating, breast||
2065|069|S|tenderness, acne, or weight gain may occur. Vaginal bleeding||
2065|070|S|between periods (spotting) or missed/irregular periods may occur,||
2065|071|S|especially during the first few months of use. If any of these||
2065|072|S|effects last or get worse, tell your doctor or pharmacist||
2065|073|S|promptly. If you miss 2 periods in a row (or 1 period if the pill||
2065|074|S|has not been used properly), contact your doctor for a pregnancy||
2065|075|S|test.||
2065|076|S|   Remember that this medication has been prescribed because your||
2065|077|S|doctor has judged that the benefit to you is greater than the||
2065|078|S|risk of side effects. Many people using this medication do not||
2065|079|S|have serious side effects.||
2065|080|S|   Tell your doctor right away if you have any serious side||
2065|081|S|effects, including: lumps in the breast, mental/mood changes||
2065|082|S|(such as new/worsening depression), severe stomach/abdominal||
2065|083|S|pain, symptoms of a high potassium blood level (such as muscle||
2065|084|S|weakness, slow/irregular heartbeat), unusual changes in vaginal||
2065|085|S|bleeding (such as continuous spotting, sudden heavy bleeding,||
2065|086|S|missed periods), dark urine, yellowing eyes/skin.||
2065|087|S|   A very serious allergic reaction to this drug is rare.||
2065|088|S|However, get medical help right away if you notice any symptoms||
2065|089|S|of a serious allergic reaction, including: rash, itching/swelling||
2065|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2065|091|S|breathing.||
2065|092|S|   This is not a complete list of possible side effects. If you||
2065|093|S|notice other effects not listed above, contact your doctor or||
2065|094|S|pharmacist.||
2065|095|S|   In the US -||
2065|096|S|   Call your doctor for medical advice about side effects. You||
2065|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2065|098|S|www.fda.gov/medwatch.||
2065|099|S|   In Canada - Call your doctor for medical advice about side||
2065|100|S|effects. You may report side effects to Health Canada at||
2065|101|S|1-866-234-2345.||
2065|102|B|||
2065|103|P|PRECAUTIONS:  Before taking drospirenone, tell your doctor or||
2065|104|P|pharmacist if you are allergic to it; or to any progestins (such||
2065|105|P|as norethindrone, desogestrel); or if you have any other||
2065|106|P|allergies. This product may contain inactive ingredients, which||
2065|107|P|can cause allergic reactions or other problems. Talk to your||
2065|108|P|pharmacist for more details.||
2065|109|P|   Before using this medication, tell your doctor or pharmacist||
2065|110|P|your medical history, especially of: adrenal gland problems,||
2065|111|P|abnormal breast exam, cancer (especially endometrial or breast||
2065|112|P|cancer), depression, diabetes, severe headaches/migraines,||
2065|113|P|history of yellowing eyes/skin (jaundice) during pregnancy or||
2065|114|P|while using hormonal birth control (such as pills, patch), kidney||
2065|115|P|disease, liver disease (including tumors), swelling (edema),||
2065|116|P|unexplained vaginal bleeding.||
2065|117|P|   If you have diabetes, this medication may affect your blood||
2065|118|P|sugar. Check your blood sugar regularly as directed and share the||
2065|119|P|results with your doctor. Tell your doctor right away if you have||
2065|120|P|symptoms of high blood sugar such as increased thirst/urination.||
2065|121|P|Your doctor may need to adjust your diabetes medication, exercise||
2065|122|P|program, or diet.||
2065|123|P|   Before having surgery, tell your doctor or dentist about all||
2065|124|P|the products you use (including prescription drugs,||
2065|125|P|nonprescription drugs, and herbal products).||
2065|126|P|   This product may increase your potassium levels. Before using||
2065|127|P|potassium supplements or salt substitutes that contain potassium,||
2065|128|P|consult your doctor or pharmacist.||
2065|129|P|   This medication may cause blotchy, dark areas on your skin||
2065|130|P|(melasma). Sunlight may worsen this effect. Avoid prolonged sun||
2065|131|P|exposure, sunlamps, and tanning booths. Use a sunscreen, and wear||
2065|132|P|protective clothing when outdoors.||
2065|133|P|   It may take longer for you to become pregnant after you stop||
2065|134|P|taking birth control pills. Consult your doctor.||
2065|135|P|   This medication should not be used during pregnancy. If you||
2065|136|P|become pregnant or think you may be pregnant, tell your doctor||
2065|137|P|right away. If you have just given birth or had a pregnancy loss||
2065|138|P|or abortion after the first 3 months, talk with your doctor about||
2065|139|P|reliable forms of birth control, and find out when it is safe to||
2065|140|P|start using birth control.||
2065|141|P|   This medication passes into breast milk in very small amounts||
2065|142|P|but is unlikely to harm a nursing infant. Consult your doctor||
2065|143|P|before breastfeeding.||
2065|144|B|||
2065|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2065|146|I|medications work or increase your risk for serious side effects.||
2065|147|I|This document does not contain all possible drug interactions.||
2065|148|I|Keep a list of all the products you use (including||
2065|149|I|prescription/nonprescription drugs and herbal products) and share||
2065|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
2065|151|I|the dosage of any medicines without your doctor's approval.||
2065|152|I|   Some products that may interact with this drug include:||
2065|153|I|atazanavir/cobicistat, fezolinetant.||
2065|154|I|   Drospirenone may raise your potassium blood level. Tell your||
2065|155|I|doctor if you are regularly taking other drugs/products that can||
2065|156|I|also raise your potassium level (including aliskiren, ACE||
2065|157|I|inhibitors such as enalapril/lisinopril, angiotensin receptor||
2065|158|I|blockers such as losartan/valsartan, heparin, NSAIDs such as||
2065|159|I|ibuprofen/naproxen, potassium-sparing "water pills"/diuretics||
2065|160|I|such as eplerenone/spironolactone/triamterene).||
2065|161|I|   Some drugs may cause hormonal birth control to work less well||
2065|162|I|by decreasing the amount of birth control hormones in your body.||
2065|163|I|This effect can result in pregnancy. Examples include||
2065|164|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
2065|165|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
2065|166|I|seizures (such as barbiturates, carbamazepine, felbamate,||
2065|167|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
2065|168|I|nevirapine), among others.||
2065|169|I|   Tell your doctor when you start any new drug, and discuss if||
2065|170|I|you should use reliable backup birth control. Also tell your||
2065|171|I|doctor if you have any new spotting or breakthrough bleeding,||
2065|172|I|because these may be signs that your birth control is not working||
2065|173|I|well.||
2065|174|I|   This medication may interfere with many lab tests, possibly||
2065|175|I|causing false test results. Make sure lab personnel and all your||
2065|176|I|doctors know you use this medication.||
2065|177|B|||
2065|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2065|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2065|180|O|poison control center right away. US residents can call||
2065|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2065|182|O|Symptoms of overdose may include: severe nausea, vomiting,||
2065|183|O|sudden/unusual vaginal bleeding.||
2065|184|B|||
2065|185|N|NOTES:  Do not share this medication with others.||
2065|186|N|   You should have regular complete physical exams including||
2065|187|N|blood pressure, breast exam, pelvic exam, and screening for||
2065|188|N|cervical cancer (Pap smear). Follow your doctor's instructions||
2065|189|N|for examining your breasts, and report any lumps right away. Keep||
2065|190|N|all medical and lab appointments. Consult your doctor for more||
2065|191|N|details.||
2065|192|B|||
2065|193|D|MISSED DOSE:  Missed dose advice is different depending on the||
2065|194|D|number of doses missed. Refer to the product package information||
2065|195|D|for advice on missed doses. You may need to use backup birth||
2065|196|D|control (such as condoms, spermicide) to prevent pregnancy. Ask||
2065|197|D|your doctor or pharmacist if you have any questions.||
2065|198|D|   If you often forget to take your pills as directed, contact||
2065|199|D|your doctor to discuss switching to another form of birth||
2065|200|D|control.||
2065|201|B|||
2065|202|R|STORAGE:  Store at room temperature away from light and moisture.||
2065|203|R|Do not store in the bathroom. Keep all medications away from||
2065|204|R|children and pets.||
2065|205|R|   Do not flush medications down the toilet or pour them into a||
2065|206|R|drain unless instructed to do so. Properly discard this product||
2065|207|R|when it is expired or no longer needed. Consult your pharmacist||
2065|208|R|or local waste disposal company.||
2065|209|B|||
2065|210|A|Information last revised October 2025.||
2065|211|A|Copyright(c) 2025 First Databank, Inc.||
2065|212|B|||
2066|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2066|002|Z|does NOT have all possible information about this product. This||
2066|003|Z|information does not assure that this product is safe, effective,||
2066|004|Z|or appropriate for you. This information is not individual||
2066|005|Z|medical advice and does not substitute for the advice of your||
2066|006|Z|health care professional. Always ask your health care||
2066|007|Z|professional for complete information about this product and your||
2066|008|Z|specific health needs.||
2066|009|B|||
2066|010|T|SELINEXOR - ORAL||
2066|011|F|(SEL-i-NEX-or)||
2066|012|B|||
2066|013|C|COMMON BRAND NAME(S): Xpovio||
2066|014|B|||
2066|015|U|USES:  This medication is used to treat certain types of cancer||
2066|016|U|(such as multiple myeloma, diffuse large B-cell lymphoma).||
2066|017|U|Selinexor works by slowing or stopping the growth of cancer||
2066|018|U|cells.||
2066|019|B|||
2066|020|H|HOW TO USE:  Read the Medication Guide provided by your||
2066|021|H|pharmacist before you start taking selinexor and each time you||
2066|022|H|get a refill. If you have any questions, ask your doctor or||
2066|023|H|pharmacist.||
2066|024|H|   Take this medication by mouth as directed by your doctor,||
2066|025|H|usually once or twice a week. Swallow the tablets whole with||
2066|026|H|water. Do not break, chew, crush, or split the tablets. Drink||
2066|027|H|plenty of fluids during treatment with this medication, unless||
2066|028|H|otherwise directed by your doctor.||
2066|029|H|   If you vomit after taking your dose of the medication, do not||
2066|030|H|take an extra dose. Take the next dose of your medication at the||
2066|031|H|regular time.||
2066|032|H|   The dosage is based on your medical condition, lab tests, and||
2066|033|H|response to treatment.||
2066|034|H|   Use this medication regularly to get the most benefit from it.||
2066|035|H|To help you remember, use it on the same day(s) and time each||
2066|036|H|week. Mark your calendar with a reminder.||
2066|037|H|   Do not increase your dose or use this drug more often or for||
2066|038|H|longer than prescribed. Your condition will not improve any||
2066|039|H|faster, and your risk of serious side effects will increase.||
2066|040|H|   Since this drug can be absorbed through the skin and lungs and||
2066|041|H|may harm an unborn baby, women who are pregnant or who may become||
2066|042|H|pregnant should not handle this medication or breathe the dust||
2066|043|H|from the tablets.||
2066|044|B|||
2066|045|S|SIDE EFFECTS:  Dizziness, tiredness, diarrhea, weight loss,||
2066|046|S|nausea, vomiting, or loss of appetite may occur. Nausea and||
2066|047|S|vomiting can be severe. In some cases, your doctor may prescribe||
2066|048|S|medication to prevent or relieve nausea and vomiting. Eating||
2066|049|S|several small meals, not eating before treatment, or limiting||
2066|050|S|activity may help lessen some of these effects. If any of these||
2066|051|S|effects last or get worse, tell your doctor or pharmacist||
2066|052|S|promptly.||
2066|053|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2066|054|S|Contact your doctor promptly if you notice any symptoms of||
2066|055|S|dehydration, such as unusual decreased urination, unusual dry||
2066|056|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness.||
2066|057|S|   People using this medication may have serious side effects.||
2066|058|S|However, you have been prescribed this drug because your doctor||
2066|059|S|has judged that the benefit to you is greater than the risk of||
2066|060|S|side effects. Careful monitoring by your doctor may decrease your||
2066|061|S|risk.||
2066|062|S|   Tell your doctor right away if you have any serious side||
2066|063|S|effects, including: signs of low level of sodium in the blood||
2066|064|S|(such as nausea that doesn't go away, extreme drowsiness,||
2066|065|S|mental/mood changes), confusion, vision changes (such as blurred||
2066|066|S|vision, decreased vision).||
2066|067|S|   This medication decreases bone marrow function, an effect that||
2066|068|S|may lead to a low number of blood cells such as red cells, white||
2066|069|S|cells, and platelets. This effect can cause anemia, decrease your||
2066|070|S|body's ability to fight an infection, or cause easy||
2066|071|S|bruising/bleeding. Tell your doctor right away if you develop any||
2066|072|S|of the following symptoms: unusual tiredness, pale skin, signs of||
2066|073|S|infection (such as sore throat that doesn't go away, fever,||
2066|074|S|chills), easy bruising/bleeding.||
2066|075|S|   Get medical help right away if you have any very serious side||
2066|076|S|effects, including: fainting, seizures.||
2066|077|S|   A very serious allergic reaction to this drug is rare.||
2066|078|S|However, get medical help right away if you notice any symptoms||
2066|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2066|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2066|081|S|breathing.||
2066|082|S|   This is not a complete list of possible side effects. If you||
2066|083|S|notice other effects not listed above, contact your doctor or||
2066|084|S|pharmacist.||
2066|085|S|   In the US -||
2066|086|S|   Call your doctor for medical advice about side effects. You||
2066|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2066|088|S|www.fda.gov/medwatch.||
2066|089|S|   In Canada - Call your doctor for medical advice about side||
2066|090|S|effects. You may report side effects to Health Canada at||
2066|091|S|1-866-234-2345.||
2066|092|B|||
2066|093|P|PRECAUTIONS:  Before taking selinexor, tell your doctor or||
2066|094|P|pharmacist if you are allergic to it; or if you have any other||
2066|095|P|allergies. This product may contain inactive ingredients, which||
2066|096|P|can cause allergic reactions or other problems. Talk to your||
2066|097|P|pharmacist for more details.||
2066|098|P|   Before using this medication, tell your doctor or pharmacist||
2066|099|P|your medical history, especially of: cataracts.||
2066|100|P|   Selinexor can make you more likely to get infections or may||
2066|101|P|make current infections worse. Stay away from anyone who has an||
2066|102|P|infection that may easily spread (such as chickenpox, COVID-19,||
2066|103|P|measles, flu). Talk to your doctor if you have been exposed to an||
2066|104|P|infection or for more details.||
2066|105|P|   Tell your health care professional that you are using||
2066|106|P|selinexor before having any immunizations/vaccinations. Avoid||
2066|107|P|contact with people who have recently received live vaccines||
2066|108|P|(such as flu vaccine inhaled through the nose).||
2066|109|P|   To lower the chance of getting cut, bruised, or injured, use||
2066|110|P|caution with sharp objects like razors and nail cutters, and||
2066|111|P|avoid activities such as contact sports.||
2066|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2066|113|P|can make you more dizzy. Do not drive, use machinery, or do||
2066|114|P|anything that needs alertness until you can do it safely. Limit||
2066|115|P|alcoholic beverages. Talk to your doctor if you are using||
2066|116|P|marijuana (cannabis).||
2066|117|P|   Before having surgery, tell your doctor or dentist about all||
2066|118|P|the products you use (including prescription drugs,||
2066|119|P|nonprescription drugs, and herbal products).||
2066|120|P|   Since this drug can be absorbed through the skin and lungs and||
2066|121|P|may harm an unborn baby, women who are pregnant or who may become||
2066|122|P|pregnant should not handle this medication or breathe the dust||
2066|123|P|from the tablets.||
2066|124|P|   Tell your doctor if you are pregnant or plan to become||
2066|125|P|pregnant. You should not become pregnant while taking selinexor.||
2066|126|P|Selinexor may harm an unborn baby. Your doctor should order a||
2066|127|P|pregnancy test before you start this medication. Men and women||
2066|128|P|using this medication should ask about reliable forms of birth||
2066|129|P|control during treatment and for 1 week after the last dose. If||
2066|130|P|you or your partner becomes pregnant, talk to your doctor right||
2066|131|P|away about the risks and benefits of this medication.||
2066|132|P|   It is unknown if this drug passes into breast milk. Because of||
2066|133|P|the possible risk to the infant, breastfeeding is not recommended||
2066|134|P|while using this drug and for 1 week after the last dose. Consult||
2066|135|P|your doctor before breastfeeding.||
2066|136|B|||
2066|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2066|138|I|medications work or increase your risk for serious side effects.||
2066|139|I|This document does not contain all possible drug interactions.||
2066|140|I|Keep a list of all the products you use (including||
2066|141|I|prescription/nonprescription drugs and herbal products) and share||
2066|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
2066|143|I|the dosage of any medicines without your doctor's approval.||
2066|144|B|||
2066|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2066|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2066|147|O|poison control center right away. US residents can call||
2066|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2066|149|B|||
2066|150|N|NOTES:  Do not share this medication with others.||
2066|151|N|   Lab and/or medical tests (such as complete blood count, sodium||
2066|152|N|levels in the blood, body weight) should be done before you start||
2066|153|N|taking this medication and while you are taking it. Keep all||
2066|154|N|medical and lab appointments. Consult your doctor for more||
2066|155|N|details.||
2066|156|B|||
2066|157|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2066|158|D|next dose at the regular time. Do not double the dose to catch||
2066|159|D|up.||
2066|160|B|||
2066|161|R|STORAGE:  Store in the refrigerator or at room temperature away||
2066|162|R|from light and moisture. Do not freeze. Do not store in the||
2066|163|R|bathroom. Keep all medications away from children and pets.||
2066|164|R|   Do not flush medications down the toilet or pour them into a||
2066|165|R|drain unless instructed to do so. Properly discard this product||
2066|166|R|when it is expired or no longer needed. Consult your pharmacist||
2066|167|R|or local waste disposal company.||
2066|168|B|||
2066|169|M|MEDICAL ALERT:  Your condition can cause complications in a||
2066|170|M|medical emergency. For information about enrolling in MedicAlert,||
2066|171|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2066|172|B|||
2066|173|A|Information last revised October 2024.||
2066|174|A|Copyright(c) 2025 First Databank, Inc.||
2066|175|B|||
2067|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2067|002|Z|does NOT have all possible information about this product. This||
2067|003|Z|information does not assure that this product is safe, effective,||
2067|004|Z|or appropriate for you. This information is not individual||
2067|005|Z|medical advice and does not substitute for the advice of your||
2067|006|Z|health care professional. Always ask your health care||
2067|007|Z|professional for complete information about this product and your||
2067|008|Z|specific health needs.||
2067|009|B|||
2067|010|T|SEGESTERONE/ETHINYL ESTRADIOL RING - VAGINAL||
2067|011|F|(se-JES-ter-one/ETH-i-nil ES-tra-DYE-ol)||
2067|012|B|||
2067|013|C|COMMON BRAND NAME(S): Annovera||
2067|014|B|||
2067|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
2067|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
2067|017|W|stroke, heart attack, blood clots, and high blood pressure from||
2067|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
2067|019|W|of these serious problems increases with age and with the number||
2067|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
2067|021|B|||
2067|022|U|USES:  This product is a vaginal ring containing combination||
2067|023|U|hormone medication and is used to prevent pregnancy. It contains||
2067|024|U|2 hormones: a progestin (segesterone) and an estrogen (ethinyl||
2067|025|U|estradiol).||
2067|026|U|   This product does not protect against sexually transmitted||
2067|027|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
2067|028|U|an effective barrier method (latex or polyurethane condom/dental||
2067|029|U|dams) during sexual activity will help to decrease your risk of||
2067|030|U|infection.||
2067|031|B|||
2067|032|H|HOW TO USE:  Read the Patient Information Leaflet and||
2067|033|H|Instructions for Use provided by your pharmacist before you start||
2067|034|H|using this product and each time you get a refill. The leaflet||
2067|035|H|contains very important information on how to properly use,||
2067|036|H|store, and dispose of the vaginal ring. If you have any||
2067|037|H|questions, ask your doctor or pharmacist.||
2067|038|H|   This product is for vaginal use only. The vaginal ring is||
2067|039|H|reusable for up to 1 full year (13 cycles). Before use, wash and||
2067|040|H|dry your hands. Remove the ring from the pouch. Wash the ring||
2067|041|H|with mild soap and water, then rinse and pat dry with a clean||
2067|042|H|cloth or paper towel before each insertion and at each removal.||
2067|043|H|Press the sides of the ring together and gently push it into your||
2067|044|H|vagina as directed, until it feels comfortable. Although some||
2067|045|H|women may be aware of the ring in the vagina, most women do not||
2067|046|H|feel it once it is in place; it will not interfere with sexual||
2067|047|H|intercourse (though your partner may be able to feel the ring).||
2067|048|H|Unlike a diaphragm, the ring's exact position in the vagina does||
2067|049|H|not affect how well it works. Once inserted, keep the ring in||
2067|050|H|place for 3 weeks in a row.||
2067|051|H|   If this is the first time you are using the ring, start using||
2067|052|H|the ring between days 2 and 5 of your period. You do not need to||
2067|053|H|use a backup form of non-hormonal birth control (such as condoms,||
2067|054|H|spermicide). If your periods are not regular or if your start day||
2067|055|H|is more than 5 days from the first day of your period, use backup||
2067|056|H|non-hormonal birth control for the first 7 days to prevent||
2067|057|H|pregnancy until the ring has enough time to work. Do not use a||
2067|058|H|diaphragm, female condom, or cervical cap for backup birth||
2067|059|H|control since the ring may interfere with proper placement.||
2067|060|H|   After using the ring for 3 weeks, remove it on the same day of||
2067|061|H|the week and about the same time that you placed it. If you have||
2067|062|H|pain/bleeding when trying to remove the ring, or if you cannot||
2067|063|H|remove it, tell your doctor right away. After removing the ring,||
2067|064|H|store it in the container provided by the manufacturer.||
2067|065|H|   Next, do not wear the ring for 1 week (7 days). You should||
2067|066|H|have your period within 2 to 3 days after the ring is removed.||
2067|067|H|After 1 ring-free week, re-insert the ring on the same day of the||
2067|068|H|week that it was removed, whether or not you have your period. If||
2067|069|H|you do not get your period, consult your doctor. Do not go longer||
2067|070|H|than 7 days without a ring. Doing so will increase your risk of||
2067|071|H|pregnancy.||
2067|072|H|   Regularly check that the ring is in your vagina, such as||
2067|073|H|before and after sexual intercourse. The ring may accidentally||
2067|074|H|fall out during sexual intercourse, during a bowel movement, or||
2067|075|H|while removing a tampon. If this happens and the ring has been||
2067|076|H|out of your vagina for less than 2 hours, wash it with mild soap||
2067|077|H|and warm water, rinse and pat dry with a clean cloth or paper||
2067|078|H|towel, and re-insert the ring as soon as possible. If the ring||
2067|079|H|has been out longer than 2 hours, you could become pregnant.||
2067|080|H|Re-insert it as directed and use a backup form of non-hormonal||
2067|081|H|birth control (such as condoms, spermicide) for the next 7 days||
2067|082|H|to prevent pregnancy.||
2067|083|H|   It is very important to follow the schedule every cycle. If||
2067|084|H|you are more than 1 or 2 days off schedule for insertion, you||
2067|085|H|will need to use a new schedule for the remaining cycles of use.||
2067|086|H|Read the manufacturer's information for details, and ask your||
2067|087|H|doctor or pharmacist if you have any questions.||
2067|088|H|   Ask your doctor or pharmacist about how to switch from other||
2067|089|H|forms of hormonal birth control (such as birth control pills) to||
2067|090|H|this product. If any information is unclear, consult the Patient||
2067|091|H|Information Leaflet or your doctor or pharmacist.||
2067|092|B|||
2067|093|S|SIDE EFFECTS:  Vaginal discomfort/irritation, nausea, vomiting,||
2067|094|S|headache, bloating, breast tenderness, swelling of the||
2067|095|S|ankles/feet (fluid retention), or weight change may occur.||
2067|096|S|Vaginal bleeding between periods (spotting) may occur, especially||
2067|097|S|during the first few months of use. If any of these effects last||
2067|098|S|or get worse, tell your doctor or pharmacist promptly. If you||
2067|099|S|miss 2 periods in a row (or 1 period if the ring has not been||
2067|100|S|used properly), contact your doctor about a pregnancy test.||
2067|101|S|   Remember that this medication has been prescribed because your||
2067|102|S|doctor has judged that the benefit to you is greater than the||
2067|103|S|risk of side effects. Many people using this medication do not||
2067|104|S|have serious side effects.||
2067|105|S|   This medication may raise your blood pressure. Check your||
2067|106|S|blood pressure regularly and tell your doctor if the results are||
2067|107|S|high.||
2067|108|S|   Tell your doctor right away if you have any serious side||
2067|109|S|effects, including: lumps in the breast, mental/mood changes||
2067|110|S|(such as new/worsening depression), severe stomach/abdominal||
2067|111|S|pain, unusual changes in vaginal bleeding (such as continuous||
2067|112|S|spotting, sudden heavy bleeding, missed periods), dark urine,||
2067|113|S|yellowing eyes/skin.||
2067|114|S|   This medication may rarely cause serious (sometimes fatal)||
2067|115|S|problems from blood clots (such as heart attack, stroke, blood||
2067|116|S|clots in the lungs or legs). Get medical help right away if you||
2067|117|S|have: chest/jaw/left arm pain, confusion, sudden||
2067|118|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
2067|119|S|trouble speaking, shortness of breath/rapid breathing,||
2067|120|S|sudden/severe headaches, unusual sweating, weakness on one side||
2067|121|S|of the body, sudden vision changes.||
2067|122|S|   Rarely, a very serious (possibly fatal) bacterial infection||
2067|123|S|(toxic shock syndrome-TSS) has occurred in women using vaginal||
2067|124|S|rings. Remove this product and get medical help right away if you||
2067|125|S|develop symptoms of toxic shock syndrome, including: sudden high||
2067|126|S|fever, severe/sudden dizziness, fainting, unusual muscle pain,||
2067|127|S|sunburn-like rash.||
2067|128|S|   A very serious allergic reaction to this drug is rare.||
2067|129|S|However, get medical help right away if you notice any symptoms||
2067|130|S|of a serious allergic reaction, including: rash, itching/swelling||
2067|131|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2067|132|S|breathing.||
2067|133|S|   This is not a complete list of possible side effects. If you||
2067|134|S|notice other effects not listed above, contact your doctor or||
2067|135|S|pharmacist.||
2067|136|S|   In the US -||
2067|137|S|   Call your doctor for medical advice about side effects. You||
2067|138|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2067|139|S|www.fda.gov/medwatch.||
2067|140|S|   In Canada - Call your doctor for medical advice about side||
2067|141|S|effects. You may report side effects to Health Canada at||
2067|142|S|1-866-234-2345.||
2067|143|B|||
2067|144|P|PRECAUTIONS:  See also Warning section.||
2067|145|P|   Before using this product, tell your doctor or pharmacist if||
2067|146|P|you are allergic to ethinyl estradiol or segesterone; or to other||
2067|147|P|estrogens or progestins; or if you have any other allergies. This||
2067|148|P|product may contain inactive ingredients, which can cause||
2067|149|P|allergic reactions or other problems. Talk to your pharmacist for||
2067|150|P|more details.||
2067|151|P|   Before using this medication, tell your doctor or pharmacist||
2067|152|P|your medical history, especially of: blood clots (for example, in||
2067|153|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
2067|154|P|C or protein S deficiency), high blood pressure, abnormal breast||
2067|155|P|exam, cancer (especially endometrial or breast cancer), high||
2067|156|P|cholesterol or triglyceride (blood fat) levels, depression,||
2067|157|P|diabetes, family or personal history of a certain swelling||
2067|158|P|disorder (angioedema), gallbladder problems, severe||
2067|159|P|headaches/migraines, heart problems (such as heart valve disease,||
2067|160|P|irregular heartbeat, previous heart attack), history of yellowing||
2067|161|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
2067|162|P|birth control (such as pills, patch), liver disease (including||
2067|163|P|tumors), obesity, stroke, swelling (edema), thyroid problems,||
2067|164|P|vaginal conditions (such as unexplained vaginal bleeding, vaginal||
2067|165|P|stenosis, prolapsed uterus).||
2067|166|P|   If you have diabetes, this medication may affect your blood||
2067|167|P|sugar. Check your blood sugar regularly as directed and share the||
2067|168|P|results with your doctor. Tell your doctor right away if you have||
2067|169|P|symptoms of high blood sugar such as increased thirst/urination.||
2067|170|P|Your doctor may need to adjust your diabetes medication, exercise||
2067|171|P|program, or diet.||
2067|172|P|   Tell your doctor if you just had or will be having surgery or||
2067|173|P|if you will be confined to a bed or chair for a long time (such||
2067|174|P|as a long plane flight). These conditions increase your risk of||
2067|175|P|getting blood clots, especially if you are using hormonal birth||
2067|176|P|control. You may need to stop this medication for a time or take||
2067|177|P|special precautions.||
2067|178|P|   Before having surgery, tell your doctor or dentist about all||
2067|179|P|the products you use (including prescription drugs,||
2067|180|P|nonprescription drugs, and herbal products).||
2067|181|P|   This medication may cause blotchy, dark areas on your skin||
2067|182|P|(melasma). Sunlight may worsen this effect. Avoid prolonged sun||
2067|183|P|exposure, sunlamps, and tanning booths. Use a sunscreen, and wear||
2067|184|P|protective clothing when outdoors.||
2067|185|P|   If you are nearsighted or wear contact lenses, you may develop||
2067|186|P|vision problems or trouble wearing your contact lenses. Contact||
2067|187|P|your eye doctor if these problems occur.||
2067|188|P|   This medication should not be used during pregnancy. If you||
2067|189|P|become pregnant or think you may be pregnant, tell your doctor||
2067|190|P|right away. If you have just given birth or had a pregnancy||
2067|191|P|loss/abortion after the first 3 months, talk with your doctor||
2067|192|P|about reliable forms of birth control, and find out when it is||
2067|193|P|safe to start using birth control that contains a form of||
2067|194|P|estrogen, such as this medication.||
2067|195|P|   A small amount of this medication passes into breast milk and||
2067|196|P|may have undesirable effects on a nursing infant. Consult your||
2067|197|P|doctor before breastfeeding.||
2067|198|B|||
2067|199|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2067|200|I|medications work or increase your risk for serious side effects.||
2067|201|I|This document does not contain all possible drug interactions.||
2067|202|I|Keep a list of all the products you use (including||
2067|203|I|prescription/nonprescription drugs and herbal products) and share||
2067|204|I|it with your doctor and pharmacist. Do not start, stop, or change||
2067|205|I|the dosage of any medicines without your doctor's approval.||
2067|206|I|   Some products that may interact with this drug are: aromatase||
2067|207|I|inhibitors (such as anastrozole, exemestane), fezolinetant,||
2067|208|I|ospemifene, tamoxifen, tizanidine, tranexamic acid.||
2067|209|I|   Do not use oil-based (including silicone-based) vaginal||
2067|210|I|lubricants or medications while using this product. These may||
2067|211|I|make this product work less well. Water-based vaginal products||
2067|212|I|will not affect this product. Ask your doctor or pharmacist if||
2067|213|I|you have questions.||
2067|214|I|   Some drugs may cause hormonal birth control to work less well||
2067|215|I|by decreasing the amount of birth control hormones in your body.||
2067|216|I|This effect can result in pregnancy. Examples include||
2067|217|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
2067|218|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
2067|219|I|seizures (such as barbiturates, carbamazepine, felbamate,||
2067|220|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
2067|221|I|nevirapine), among others.||
2067|222|I|   Tell your doctor when you start any new drug, and discuss if||
2067|223|I|you should use reliable non-hormonal backup birth control. Also||
2067|224|I|tell your doctor if you have any new spotting or breakthrough||
2067|225|I|bleeding, because these may be signs that your birth control is||
2067|226|I|not working well.||
2067|227|I|   This medication may interfere with many lab tests, possibly||
2067|228|I|causing false test results. Make sure lab personnel and all your||
2067|229|I|doctors know you use this medication.||
2067|230|B|||
2067|231|O|OVERDOSE:  This product may be harmful if swallowed. Overdose||
2067|232|O|with this product is highly unlikely. Do not use more than one||
2067|233|O|ring at a time. If someone has overdosed, remove the ring if||
2067|234|O|possible. For serious symptoms such as passing out or trouble||
2067|235|O|breathing, call 911. Otherwise, call a poison control center||
2067|236|O|right away. US residents can call 1-800-222-1222. Canada||
2067|237|O|residents can call 1-844-764-7669.||
2067|238|B|||
2067|239|N|NOTES:  Do not share this medication with others.||
2067|240|N|   You should have regular complete physical exams including||
2067|241|N|blood pressure, breast exam, pelvic exam, and screening for||
2067|242|N|cervical cancer (Pap smear). Follow your doctor's instructions||
2067|243|N|for examining your breasts, and report any lumps right away. Keep||
2067|244|N|all medical and lab appointments. Consult your doctor for more||
2067|245|N|details.||
2067|246|B|||
2067|247|D|MISSED DOSE:  Refer to the product package information for||
2067|248|D|instructions. You may need to use backup birth control (such as||
2067|249|D|condoms, spermicide) to prevent pregnancy. Ask your doctor or||
2067|250|D|pharmacist if you have any questions.||
2067|251|D|   If you have trouble remembering to remove and reinsert the||
2067|252|D|ring as directed, or if it falls out repeatedly, contact your||
2067|253|D|doctor to discuss switching to another form of birth control.||
2067|254|B|||
2067|255|R|STORAGE:  Store this product at room temperature away from direct||
2067|256|R|sunlight and high heat. Do not refrigerate or freeze. Keep all||
2067|257|R|medications away from children and pets.||
2067|258|R|   Do not flush medications down the toilet or pour them into a||
2067|259|R|drain unless instructed to do so. Properly discard this product||
2067|260|R|when it is expired or no longer needed.||
2067|261|B|||
2067|262|A|Information last revised October 2025.||
2067|263|A|Copyright(c) 2025 First Databank, Inc.||
2067|264|B|||
2068|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2068|002|Z|does NOT have all possible information about this product. This||
2068|003|Z|information does not assure that this product is safe, effective,||
2068|004|Z|or appropriate for you. This information is not individual||
2068|005|Z|medical advice and does not substitute for the advice of your||
2068|006|Z|health care professional. Always ask your health care||
2068|007|Z|professional for complete information about this product and your||
2068|008|Z|specific health needs.||
2068|009|B|||
2068|010|T|TAFAMIDIS - ORAL||
2068|011|F|(ta-FAM-id-is)||
2068|012|B|||
2068|013|C|COMMON BRAND NAME(S): Vyndamax, Vyndaqel||
2068|014|B|||
2068|015|U|USES:  This medication is used to treat a certain type of heart||
2068|016|U|failure (transthyretin-mediated amyloidosis). It is used to help||
2068|017|U|prevent the heart failure from getting worse and needing||
2068|018|U|treatment in a hospital. Tafamidis works by slowing the buildup||
2068|019|U|of a certain protein (amyloid fibrils) that causes heart||
2068|020|U|problems.||
2068|021|B|||
2068|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2068|023|H|from your pharmacist before you start taking tafamidis and each||
2068|024|H|time you get a refill. If you have any questions, ask your doctor||
2068|025|H|or pharmacist.||
2068|026|H|   Take this medication by mouth as directed by your doctor,||
2068|027|H|usually once daily. Swallow the capsules whole. Do not crush or||
2068|028|H|cut the capsules. The dosage is based on your medical condition||
2068|029|H|and response to treatment.||
2068|030|H|   Different brands of this medication contain different amounts||
2068|031|H|of drug and cannot be substituted for each other. Do not change||
2068|032|H|brands unless directed by your doctor.||
2068|033|H|   Use this medication regularly to get the most benefit from it.||
2068|034|H|To help you remember, take it at the same time each day.||
2068|035|H|   Tell your doctor if your condition does not get better or if||
2068|036|H|it gets worse.||
2068|037|B|||
2068|038|S|SIDE EFFECTS:  Tafamidis usually has very few side effects. If||
2068|039|S|you have any unusual effects, tell your doctor or pharmacist||
2068|040|S|promptly.||
2068|041|S|   Remember that this medication has been prescribed because your||
2068|042|S|doctor has judged that the benefit to you is greater than the||
2068|043|S|risk of side effects. Many people using this medication do not||
2068|044|S|have serious side effects.||
2068|045|S|   A very serious allergic reaction to this drug is rare.||
2068|046|S|However, get medical help right away if you notice any symptoms||
2068|047|S|of a serious allergic reaction, including: rash, itching/swelling||
2068|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2068|049|S|breathing.||
2068|050|S|   This is not a complete list of possible side effects. If you||
2068|051|S|notice other effects not listed above, contact your doctor or||
2068|052|S|pharmacist.||
2068|053|S|   In the US -||
2068|054|S|   Call your doctor for medical advice about side effects. You||
2068|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2068|056|S|www.fda.gov/medwatch.||
2068|057|S|   In Canada - Call your doctor for medical advice about side||
2068|058|S|effects. You may report side effects to Health Canada at||
2068|059|S|1-866-234-2345.||
2068|060|B|||
2068|061|P|PRECAUTIONS:  Before taking tafamidis, tell your doctor or||
2068|062|P|pharmacist if you are allergic to it; or if you have any other||
2068|063|P|allergies. This product may contain inactive ingredients, which||
2068|064|P|can cause allergic reactions or other problems. Talk to your||
2068|065|P|pharmacist for more details.||
2068|066|P|   Before using this medication, tell your doctor or pharmacist||
2068|067|P|your medical history, especially of: liver problems.||
2068|068|P|   Before having surgery, tell your doctor or dentist about all||
2068|069|P|the products you use (including prescription drugs,||
2068|070|P|nonprescription drugs, and herbal products).||
2068|071|P|   Tell your doctor if you are pregnant or plan to become||
2068|072|P|pregnant. You should not become pregnant while using tafamidis.||
2068|073|P|Tafamidis may harm an unborn baby. If you become pregnant, talk||
2068|074|P|to your doctor right away about the risks and benefits of this||
2068|075|P|medication.||
2068|076|P|   It is unknown if this medication passes into breast milk.||
2068|077|P|Breastfeeding is not recommended while using this medication.||
2068|078|P|Consult your doctor before breastfeeding.||
2068|079|B|||
2068|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2068|081|I|medications work or increase your risk for serious side effects.||
2068|082|I|This document does not contain all possible drug interactions.||
2068|083|I|Keep a list of all the products you use (including||
2068|084|I|prescription/nonprescription drugs and herbal products) and share||
2068|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
2068|086|I|the dosage of any medicines without your doctor's approval.||
2068|087|I|   This medication may interfere with certain lab tests (such as||
2068|088|I|thyroid tests), possibly causing false test results. Make sure||
2068|089|I|lab personnel and all your doctors know you use this drug.||
2068|090|B|||
2068|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2068|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2068|093|O|poison control center right away. US residents can call||
2068|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2068|095|B|||
2068|096|N|NOTES:  Do not share this medication with others.||
2068|097|B|||
2068|098|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2068|099|D|remember. If it is near the time of the next dose, skip the||
2068|100|D|missed dose. Take your next dose at the regular time. Do not||
2068|101|D|double the dose to catch up.||
2068|102|B|||
2068|103|R|STORAGE:  Store at room temperature away from light and moisture.||
2068|104|R|Do not store in the bathroom. Keep all medications away from||
2068|105|R|children and pets.||
2068|106|R|   Do not flush medications down the toilet or pour them into a||
2068|107|R|drain unless instructed to do so. Properly discard this product||
2068|108|R|when it is expired or no longer needed. Consult your pharmacist||
2068|109|R|or local waste disposal company.||
2068|110|B|||
2068|111|A|Information last revised May 2024.||
2068|112|A|Copyright(c) 2025 First Databank, Inc.||
2068|113|B|||
2072|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2072|002|Z|does NOT have all possible information about this product. This||
2072|003|Z|information does not assure that this product is safe, effective,||
2072|004|Z|or appropriate for you. This information is not individual||
2072|005|Z|medical advice and does not substitute for the advice of your||
2072|006|Z|health care professional. Always ask your health care||
2072|007|Z|professional for complete information about this product and your||
2072|008|Z|specific health needs.||
2072|009|B|||
2072|010|T|COLISTIMETHATE - INJECTION||
2072|011|F|(koe-LIS-ti-METH-ate)||
2072|012|B|||
2072|013|C|COMMON BRAND NAME(S): Coly-Mycin M||
2072|014|B|||
2072|015|U|USES:  Colistimethate is an antibiotic used to treat certain||
2072|016|U|bacterial infections. It works by stopping the growth of||
2072|017|U|bacteria.||
2072|018|B|||
2072|019|V|OTHER USES:  This section contains uses of this drug that are not||
2072|020|V|listed in the approved US professional labeling for the drug but||
2072|021|V|that may be prescribed by your health care professional. Use this||
2072|022|V|drug for a condition that is listed in this section only if it||
2072|023|V|has been so prescribed by your health care professional.||
2072|024|V|   In people with cystic fibrosis, inhaled colistimethate may||
2072|025|V|also be used for serious bacterial lung infections (Pseudomonas||
2072|026|V|aeruginosa). See also Storage section for information about||
2072|027|V|important safety concerns when this medication is inhaled.||
2072|028|B|||
2072|029|H|HOW TO USE:  Colistimethate for injection is usually given into a||
2072|030|H|vein or a muscle as directed by your doctor. The dosage is based||
2072|031|H|on your medical condition and response to treatment.||
2072|032|H|   If you are giving this medication to yourself at home, learn||
2072|033|H|all preparation and usage instructions from your health care||
2072|034|H|professional. Before using, check this product for particles or||
2072|035|H|discoloration. If either is present, do not use the liquid. Learn||
2072|036|H|how to store and discard medical supplies safely.||
2072|037|H|   If you are inhaling this medication, learn how to prepare the||
2072|038|H|solution and use the nebulizer machine properly. See also the||
2072|039|H|Storage section. If you have any questions, ask your health care||
2072|040|H|professional.||
2072|041|H|   For the best effect, use this antibiotic at evenly spaced||
2072|042|H|times. To help you remember, use this medication at the same||
2072|043|H|time(s) every day.||
2072|044|H|   Continue to use this medication until the full prescribed||
2072|045|H|amount is finished, even if symptoms disappear after a few days.||
2072|046|H|Stopping the medication too early may result in a return of the||
2072|047|H|infection.||
2072|048|H|   Tell your doctor if your condition does not get better or if||
2072|049|H|it gets worse.||
2072|050|B|||
2072|051|S|SIDE EFFECTS:  Stomach upset and itching may occur. If either of||
2072|052|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2072|053|S|promptly.||
2072|054|S|   Remember that this medication has been prescribed because your||
2072|055|S|doctor has judged that the benefit to you is greater than the||
2072|056|S|risk of side effects. Many people using this medication do not||
2072|057|S|have serious side effects.||
2072|058|S|   Tell your doctor right away if you have any serious side||
2072|059|S|effects, including: numbness/tingling (especially of the||
2072|060|S|arms/legs, around the mouth/tongue), strange feeling on the skin||
2072|061|S|of the arms/legs, mental/mood changes (such as confusion,||
2072|062|S|psychosis, seizures), difficulty walking, unsteadiness,||
2072|063|S|slow/shallow/troubled breathing, dizziness/feeling of spinning,||
2072|064|S|unexplained fever, trouble speaking, muscle cramps/weakness,||
2072|065|S|signs of kidney problems (such as change in the amount of urine),||
2072|066|S|red/pink urine.||
2072|067|S|   This medication may rarely cause a severe intestinal condition||
2072|068|S|due to a bacteria called C. difficile. This condition may occur||
2072|069|S|during treatment or weeks to months after treatment has stopped.||
2072|070|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2072|071|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2072|072|S|stool.||
2072|073|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2072|074|S|products because they may make symptoms worse.||
2072|075|S|   Use of this medication for prolonged or repeated periods may||
2072|076|S|result in a new infection. Tell your doctor if you notice any||
2072|077|S|symptoms of a new infection (such as white patches in your mouth,||
2072|078|S|a change in vaginal discharge).||
2072|079|S|   A very serious allergic reaction to this drug is rare.||
2072|080|S|However, get medical help right away if you notice any symptoms||
2072|081|S|of a serious allergic reaction, including: rash, itching/swelling||
2072|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2072|083|S|breathing.||
2072|084|S|   This is not a complete list of possible side effects. If you||
2072|085|S|notice other effects not listed above, contact your doctor or||
2072|086|S|pharmacist.||
2072|087|S|   In the US -||
2072|088|S|   Call your doctor for medical advice about side effects. You||
2072|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2072|090|S|www.fda.gov/medwatch.||
2072|091|S|   In Canada - Call your doctor for medical advice about side||
2072|092|S|effects. You may report side effects to Health Canada at||
2072|093|S|1-866-234-2345.||
2072|094|B|||
2072|095|P|PRECAUTIONS:  Before using colistimethate, tell your doctor or||
2072|096|P|pharmacist if you are allergic to it; or to polymyxin B or||
2072|097|P|colistin; or if you have any other allergies. This product may||
2072|098|P|contain inactive ingredients, which can cause allergic reactions||
2072|099|P|or other problems. Talk to your pharmacist for more details.||
2072|100|P|   Before using this medication, tell your doctor or pharmacist||
2072|101|P|your medical history, especially of: diseases of the||
2072|102|P|nerves/muscles (such as myasthenia gravis), kidney disease.||
2072|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2072|104|P|can make you more dizzy. Do not drive, use machinery, or do||
2072|105|P|anything that needs alertness until you can do it safely. Limit||
2072|106|P|alcoholic beverages. Talk to your doctor if you are using||
2072|107|P|marijuana (cannabis).||
2072|108|P|   Before having surgery or any procedure requiring anesthesia or||
2072|109|P|medications that block nerve or muscle activity, tell your doctor||
2072|110|P|or dentist that you are using this medication.||
2072|111|P|   This medication may cause live bacterial vaccines (such as||
2072|112|P|typhoid vaccine) to not work well. Tell your health care||
2072|113|P|professional that you are using this medication before having any||
2072|114|P|immunizations/vaccinations.||
2072|115|P|   Older adults may be more sensitive to the side effects of this||
2072|116|P|drug, especially kidney problems.||
2072|117|P|   During pregnancy, this medication should be used only when||
2072|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
2072|119|P|   It is unknown if this drug passes into breast milk. Consult||
2072|120|P|your doctor before breastfeeding.||
2072|121|B|||
2072|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2072|123|I|medications work or increase your risk for serious side effects.||
2072|124|I|This document does not contain all possible drug interactions.||
2072|125|I|Keep a list of all the products you use (including||
2072|126|I|prescription/nonprescription drugs and herbal products) and share||
2072|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
2072|128|I|the dosage of any medicines without your doctor's approval.||
2072|129|I|   Some products that may interact with this drug include:||
2072|130|I|cephalothin.||
2072|131|B|||
2072|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2072|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2072|134|O|poison control center right away. US residents can call||
2072|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2072|136|O|Symptoms of overdose may include: extreme drowsiness,||
2072|137|O|slow/shallow breathing, muscle weakness, inability to move.||
2072|138|B|||
2072|139|N|NOTES:  Lab and/or medical tests (such as kidney function, blood||
2072|140|N|mineral levels) should be done while you are using this||
2072|141|N|medication. Keep all medical and lab appointments. Consult your||
2072|142|N|doctor for more details.||
2072|143|B|||
2072|144|D|MISSED DOSE:  It is important to get each dose of this medication||
2072|145|D|as scheduled. If you miss an injection, ask your doctor or||
2072|146|D|pharmacist right away for a new dosing schedule. Do not double||
2072|147|D|the dose to catch up.||
2072|148|D|   If you miss an inhaled dose, use it as soon as you remember.||
2072|149|D|If it is near the time of the next dose, skip the missed dose.||
2072|150|D|Use your next dose at the regular time. Do not double the dose to||
2072|151|D|catch up.||
2072|152|B|||
2072|153|R|STORAGE:  For colistimethate injection, consult the product||
2072|154|R|instructions and your pharmacist for storage details.||
2072|155|R|   If you are using colistimethate as an inhalation, store the||
2072|156|R|unmixed vials at room temperature. Do not use premixed solution||
2072|157|R|or prepare the solution ahead of time because this increases the||
2072|158|R|risk of very serious breathing problems. Prepare the inhalation||
2072|159|R|solution right before use. Discard any unused solution after 24||
2072|160|R|hours. Do not store for longer periods. Ask your health care||
2072|161|R|professional for details.||
2072|162|R|   Keep all medications away from children and pets.||
2072|163|R|   Do not flush medications down the toilet or pour them into a||
2072|164|R|drain unless instructed to do so. Properly discard this product||
2072|165|R|when it is expired or no longer needed. Consult your pharmacist||
2072|166|R|or local waste disposal company.||
2072|167|B|||
2072|168|A|Information last revised July 2025.||
2072|169|A|Copyright(c) 2025 First Databank, Inc.||
2072|170|B|||
2073|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2073|002|Z|does NOT have all possible information about this product. This||
2073|003|Z|information does not assure that this product is safe, effective,||
2073|004|Z|or appropriate for you. This information is not individual||
2073|005|Z|medical advice and does not substitute for the advice of your||
2073|006|Z|health care professional. Always ask your health care||
2073|007|Z|professional for complete information about this product and your||
2073|008|Z|specific health needs.||
2073|009|B|||
2073|010|T|MELPHALAN - INJECTION||
2073|011|F|(MEL-fa-lan)||
2073|012|B|||
2073|013|C|COMMON BRAND NAME(S): Alkeran, Evomela, Ivra||
2073|014|B|||
2073|015|W|WARNING:  Although melphalan is used to treat cancer, it may||
2073|016|W|rarely increase your risk of developing other cancers. Also,||
2073|017|W|melphalan may cause a severe decrease in your blood cells, which||
2073|018|W|lowers your ability to fight infections and increases the risk of||
2073|019|W|anemia/bleeding problems. You may be more likely to get a serious||
2073|020|W|(rarely fatal) infection or any infection you have may get worse.||
2073|021|W|Tell your doctor right away if you develop unusual growths or||
2073|022|W|lumps, swollen lymph nodes, signs of infection (such as sore||
2073|023|W|throat that doesn't go away, fever, chills), easy or unusual||
2073|024|W|bruising/bleeding, or unusual tiredness.||
2073|025|W|   Melphalan may cause a serious allergic reaction. Get medical||
2073|026|W|help right away if you develop rash, itching/swelling (especially||
2073|027|W|of the face/tongue/throat), severe dizziness, or trouble||
2073|028|W|breathing.||
2073|029|B|||
2073|030|U|USES:  This medication is used to treat certain types of cancer||
2073|031|U|(such as multiple myeloma, ovarian). Melphalan is also used as a||
2073|032|U|pretreatment for people who are undergoing a stem cell transplant||
2073|033|U|for multiple myeloma. Melphalan belongs to a class of drugs known||
2073|034|U|as alkylating agents. It works by slowing or stopping the growth||
2073|035|U|of cancer cells.||
2073|036|B|||
2073|037|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2073|038|H|from your pharmacist before you start using melphalan and each||
2073|039|H|time you receive this medication. If you have any questions, ask||
2073|040|H|your doctor or pharmacist.||
2073|041|H|   This medication is given by a health care professional. It is||
2073|042|H|injected slowly into a vein over 15 to 30 minutes.||
2073|043|H|   The dosage and treatment schedule are based on your medical||
2073|044|H|condition, lab tests, and response to treatment.||
2073|045|H|   Use this medication regularly to get the most benefit from it.||
2073|046|H|To help you remember, mark your calendar with a reminder.||
2073|047|H|   It may take several months before you see a benefit from this||
2073|048|H|drug.||
2073|049|B|||
2073|050|S|SIDE EFFECTS:  See also Warning section.||
2073|051|S|   Nausea, vomiting, diarrhea, lip/mouth sores, or loss of||
2073|052|S|appetite may occur. Nausea and vomiting can be severe. In some||
2073|053|S|cases, your doctor may prescribe medication to prevent or relieve||
2073|054|S|nausea and vomiting. Eating several small meals, not eating||
2073|055|S|before treatment, or limiting activity may help lessen some of||
2073|056|S|these effects. If any of these effects last or get worse, tell||
2073|057|S|your doctor or pharmacist promptly.||
2073|058|S|   Pain or sores in the mouth and throat may occur. Brush your||
2073|059|S|teeth carefully/gently, avoid using mouthwash that contains||
2073|060|S|alcohol, and rinse your mouth often with cool water mixed with||
2073|061|S|baking soda or salt. It may also be best to eat soft, moist||
2073|062|S|foods.||
2073|063|S|   Temporary hair loss may occur. Normal hair growth should||
2073|064|S|return after treatment has ended.||
2073|065|S|   People using this medication may have serious side effects.||
2073|066|S|However, you have been prescribed this drug because your doctor||
2073|067|S|has judged that the benefit to you is greater than the risk of||
2073|068|S|side effects. Careful monitoring by your doctor may decrease your||
2073|069|S|risk.||
2073|070|S|   Tell your doctor right away if you have any serious side||
2073|071|S|effects, including: shortness of breath, signs of liver disease||
2073|072|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
2073|073|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2073|074|S|   A very serious allergic reaction to this drug is rare.||
2073|075|S|However, get medical help right away if you notice any symptoms||
2073|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2073|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2073|078|S|breathing.||
2073|079|S|   This is not a complete list of possible side effects. If you||
2073|080|S|notice other effects not listed above, contact your doctor or||
2073|081|S|pharmacist.||
2073|082|S|   In the US -||
2073|083|S|   Call your doctor for medical advice about side effects. You||
2073|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2073|085|S|www.fda.gov/medwatch.||
2073|086|S|   In Canada - Call your doctor for medical advice about side||
2073|087|S|effects. You may report side effects to Health Canada at||
2073|088|S|1-866-234-2345.||
2073|089|B|||
2073|090|P|PRECAUTIONS:  Before using melphalan, tell your doctor or||
2073|091|P|pharmacist if you are allergic to it; or to chlorambucil; or if||
2073|092|P|you have any other allergies. This product may contain inactive||
2073|093|P|ingredients, which can cause allergic reactions or other||
2073|094|P|problems. Talk to your pharmacist for more details.||
2073|095|P|   Before using this medication, tell your doctor or pharmacist||
2073|096|P|your medical history, especially of: bleeding/blood problems,||
2073|097|P|kidney problems, radiation treatment.||
2073|098|P|   Melphalan can make you more likely to get infections or may||
2073|099|P|make current infections worse. Stay away from anyone who has an||
2073|100|P|infection that may easily spread (such as chickenpox, COVID-19,||
2073|101|P|measles, flu). Talk to your doctor if you have been exposed to an||
2073|102|P|infection or for more details.||
2073|103|P|   Tell your health care professional that you are using||
2073|104|P|melphalan before having any immunizations/vaccinations. Avoid||
2073|105|P|contact with people who have recently received live vaccines||
2073|106|P|(such as flu vaccine inhaled through the nose).||
2073|107|P|   To lower the chance of getting cut, bruised, or injured, use||
2073|108|P|caution with sharp objects like razors and nail cutters, and||
2073|109|P|avoid activities such as contact sports.||
2073|110|P|   Before having surgery, tell your doctor or dentist about all||
2073|111|P|the products you use (such as prescription drugs, nonprescription||
2073|112|P|drugs, and herbal products).||
2073|113|P|   This medication can affect fertility in both males and||
2073|114|P|females. Ask your doctor for more details.||
2073|115|P|   Tell your doctor if you are pregnant or plan to become||
2073|116|P|pregnant. You should not become pregnant while you are using||
2073|117|P|melphalan. Melphalan may harm an unborn baby. Your doctor should||
2073|118|P|order a pregnancy test before you start this medication. Women||
2073|119|P|using this medication should ask about reliable forms of birth||
2073|120|P|control during treatment and for 6 months after the last dose.||
2073|121|P|Men using this medication should ask about reliable forms of||
2073|122|P|birth control during treatment and for 3 months after the last||
2073|123|P|dose. If you or your partner becomes pregnant, talk to your||
2073|124|P|doctor right away about the risks and benefits of this||
2073|125|P|medication.||
2073|126|P|   It is unknown if this drug passes into breast milk. Because of||
2073|127|P|the possible risk to the infant, breastfeeding is not recommended||
2073|128|P|while using this drug and for 1 week after the last dose. Consult||
2073|129|P|your doctor before breastfeeding.||
2073|130|B|||
2073|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2073|132|I|medications work or increase your risk for serious side effects.||
2073|133|I|This document does not contain all possible drug interactions.||
2073|134|I|Keep a list of all the products you use (including||
2073|135|I|prescription/nonprescription drugs and herbal products) and share||
2073|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
2073|137|I|the dosage of any medicines without your doctor's approval.||
2073|138|I|   Melphalan is very similar to melphalan flufenamide. Do not use||
2073|139|I|medications containing melphalan flufenamide while using||
2073|140|I|melphalan.||
2073|141|B|||
2073|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2073|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2073|144|O|poison control center right away. US residents can call||
2073|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2073|146|B|||
2073|147|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2073|148|N|liver function) should be done while you are using this||
2073|149|N|medication. Keep all medical and lab appointments.||
2073|150|B|||
2073|151|D|MISSED DOSE:  It is important to get each dose of this medication||
2073|152|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2073|153|D|right away for a new dosing schedule.||
2073|154|B|||
2073|155|R|STORAGE:  Not applicable. This medication is given in a hospital||
2073|156|R|or clinic and will not be stored at home.||
2073|157|B|||
2073|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
2073|159|M|medical emergency. For information about enrolling in MedicAlert,||
2073|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2073|161|B|||
2073|162|A|Information last revised April 2025.||
2073|163|A|Copyright(c) 2025 First Databank, Inc.||
2073|164|B|||
2074|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2074|002|Z|does NOT have all possible information about this product. This||
2074|003|Z|information does not assure that this product is safe, effective,||
2074|004|Z|or appropriate for you. This information is not individual||
2074|005|Z|medical advice and does not substitute for the advice of your||
2074|006|Z|health care professional. Always ask your health care||
2074|007|Z|professional for complete information about this product and your||
2074|008|Z|specific health needs.||
2074|009|B|||
2074|010|T|GLUCAGON SPRAY - NASAL||
2074|011|F|(GLOO-ka-gon)||
2074|012|B|||
2074|013|C|COMMON BRAND NAME(S): Baqsimi||
2074|014|B|||
2074|015|U|USES:  This medication is the same as your body's own glucagon, a||
2074|016|U|natural substance that raises blood sugar by causing the body to||
2074|017|U|release sugar stored in the liver. It is used to treat very low||
2074|018|U|blood sugar (hypoglycemia) that may cause you to need help from||
2074|019|U|others. Make sure a family member or caregiver knows where you||
2074|020|U|keep this medication and how to use it before you need their||
2074|021|U|help.||
2074|022|B|||
2074|023|H|HOW TO USE:  Read the Patient Information Leaflet and||
2074|024|H|Instructions for Use provided by your pharmacist when you get||
2074|025|H|this medication and each time you get a refill. Be sure to keep||
2074|026|H|this medication handy in case it is needed. Learn ahead of time||
2074|027|H|how to properly give this medication. Each nasal spray device can||
2074|028|H|be used only one time. If you have any questions, ask your doctor||
2074|029|H|or pharmacist.||
2074|030|H|   Caregivers should know the symptoms of low blood sugar (see||
2074|031|H|also Precautions section) and be instructed on how to give||
2074|032|H|glucagon if needed. An episode of very low blood sugar should be||
2074|033|H|treated right away to prevent serious effects (such as brain||
2074|034|H|damage).||
2074|035|H|   Remove the glucagon spray from the package only when you are||
2074|036|H|ready to use it. Gently insert the tip of the spray nozzle into||
2074|037|H|one nostril, then firmly press the plunger to give the dose. This||
2074|038|H|medication does not need to be inhaled to work. After giving this||
2074|039|H|medication, get medical help right away. If the person is||
2074|040|H|unconscious, turn the person on their side. If the person does||
2074|041|H|not wake up after 15 minutes, another dose may be given, if||
2074|042|H|available.||
2074|043|H|   When the person wakes up and is able to swallow, a quick sugar||
2074|044|H|source (such as glucose tablets, juice) should be given. Glucagon||
2074|045|H|is only effective for a short time, and low blood sugar may||
2074|046|H|return. The blood sugar level should be kept up by eating snacks||
2074|047|H|such as crackers, cheese, a meat sandwich, or milk.||
2074|048|H|   Always call your doctor right away when an episode of very low||
2074|049|H|blood sugar has happened. You may need more medical treatment, or||
2074|050|H|your insulin dose and diet may need to be adjusted.||
2074|051|B|||
2074|052|S|SIDE EFFECTS:  Nausea, vomiting, headache, runny/stuffy nose,||
2074|053|S|nose/throat itching, or watery eyes may occur. If any of these||
2074|054|S|effects last or get worse, tell your doctor promptly.||
2074|055|S|   Remember that this medication has been prescribed because your||
2074|056|S|doctor has judged that the benefit to you is greater than the||
2074|057|S|risk of side effects. Many people using this medication do not||
2074|058|S|have serious side effects.||
2074|059|S|   Tell your doctor right away if you have any serious side||
2074|060|S|effects, including: fast/pounding heartbeat.||
2074|061|S|   A very serious allergic reaction to this drug is rare.||
2074|062|S|However, get medical help right away if you notice any symptoms||
2074|063|S|of a serious allergic reaction, including: rash, itching/swelling||
2074|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2074|065|S|breathing.||
2074|066|S|   This is not a complete list of possible side effects. If you||
2074|067|S|notice other effects not listed above, contact your doctor or||
2074|068|S|pharmacist.||
2074|069|S|   In the US -||
2074|070|S|   Call your doctor for medical advice about side effects. You||
2074|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2074|072|S|www.fda.gov/medwatch.||
2074|073|S|   In Canada - Call your doctor for medical advice about side||
2074|074|S|effects. You may report side effects to Health Canada at||
2074|075|S|1-866-234-2345.||
2074|076|B|||
2074|077|P|PRECAUTIONS:  Before using glucagon, tell your doctor or||
2074|078|P|pharmacist if you are allergic to it; or if you have any other||
2074|079|P|allergies. This product may contain inactive ingredients, which||
2074|080|P|can cause allergic reactions or other problems. Talk to your||
2074|081|P|pharmacist for more details.||
2074|082|P|   Before using this medication, tell your doctor or pharmacist||
2074|083|P|your medical history, especially of: tumor in the pancreas||
2074|084|P|(insulinoma), adrenal gland problem (such as Addison's disease,||
2074|085|P|pheochromocytoma), not eating/poor eating habits, frequent low||
2074|086|P|blood sugar.||
2074|087|P|   Low blood sugar (hypoglycemia) is more likely if you do not||
2074|088|P|consume enough calories from food, or if you do unusually heavy||
2074|089|P|exercise. Symptoms include sudden sweating, shaking, fast||
2074|090|P|heartbeat, hunger, blurred vision, dizziness, or tingling||
2074|091|P|hands/feet. It is a good habit to carry glucose tablets or gel to||
2074|092|P|treat low blood sugar. If you don't have these reliable forms of||
2074|093|P|glucose, rapidly raise your blood sugar by eating a quick source||
2074|094|P|of sugar such as table sugar, honey, or candy, or drink fruit||
2074|095|P|juice or non-diet soda. Tell your doctor about the reaction right||
2074|096|P|away. To help prevent low blood sugar, eat meals on a regular||
2074|097|P|schedule, and do not skip meals. Check with your doctor or||
2074|098|P|pharmacist to find out what you should do if you miss a meal.||
2074|099|P|   Before having surgery, tell your doctor or dentist about all||
2074|100|P|the products you use (including prescription drugs,||
2074|101|P|nonprescription drugs, and herbal products).||
2074|102|P|   Tell your doctor if you are pregnant before using this||
2074|103|P|medication.||
2074|104|P|   It is unknown if this drug passes into breast milk. However,||
2074|105|P|it is unlikely to harm a nursing infant. Consult your doctor||
2074|106|P|before breastfeeding.||
2074|107|B|||
2074|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2074|109|I|medications work or increase your risk for serious side effects.||
2074|110|I|This document does not contain all possible drug interactions.||
2074|111|I|Keep a list of all the products you use (including||
2074|112|I|prescription/nonprescription drugs and herbal products) and share||
2074|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
2074|114|I|the dosage of any medicines without your doctor's approval.||
2074|115|B|||
2074|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2074|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2074|118|O|poison control center right away. US residents can call||
2074|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2074|120|B|||
2074|121|N|NOTES:  Do not share this medication with others.||
2074|122|N|   Attend a diabetes education program to learn more about how to||
2074|123|N|manage your diabetes with medications, diet, exercise, and||
2074|124|N|regular medical exams.||
2074|125|N|   Learn the symptoms of high and low blood sugar and how to||
2074|126|N|treat low blood sugar. Check your blood sugar regularly as||
2074|127|N|directed.||
2074|128|B|||
2074|129|D|MISSED DOSE:  Not applicable.||
2074|130|B|||
2074|131|R|STORAGE:  Store at room temperature away from moisture. Do not||
2074|132|R|unwrap the device until you are ready to use it. Do not store in||
2074|133|R|the bathroom. Keep all medications away from children and pets.||
2074|134|R|   Do not flush medications down the toilet or pour them into a||
2074|135|R|drain unless instructed to do so. Properly discard this product||
2074|136|R|when it is expired or no longer needed. Consult your pharmacist||
2074|137|R|or local waste disposal company.||
2074|138|B|||
2074|139|M|MEDICAL ALERT:  Your condition can cause complications in a||
2074|140|M|medical emergency. For information about enrolling in MedicAlert,||
2074|141|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2074|142|B|||
2074|143|A|Information last revised March 2025.||
2074|144|A|Copyright(c) 2025 First Databank, Inc.||
2074|145|B|||
2075|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2075|002|Z|does NOT have all possible information about this product. This||
2075|003|Z|information does not assure that this product is safe, effective,||
2075|004|Z|or appropriate for you. This information is not individual||
2075|005|Z|medical advice and does not substitute for the advice of your||
2075|006|Z|health care professional. Always ask your health care||
2075|007|Z|professional for complete information about this product and your||
2075|008|Z|specific health needs.||
2075|009|B|||
2075|010|T|MOEXIPRIL - ORAL||
2075|011|F|(moe-EX-i-pril)||
2075|012|B|||
2075|013|C|COMMON BRAND NAME(S): Univasc||
2075|014|B|||
2075|015|W|WARNING:  Moexipril can cause serious (possibly fatal) harm to an||
2075|016|W|unborn baby if used during pregnancy. It is important to prevent||
2075|017|W|pregnancy while taking this medication. Consult your doctor for||
2075|018|W|more details and to discuss the use of reliable forms of birth||
2075|019|W|control while taking this medication. If you are planning||
2075|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
2075|021|W|your doctor right away.||
2075|022|B|||
2075|023|U|USES:  Moexipril is used to treat high blood pressure. Lowering||
2075|024|U|high blood pressure helps prevent strokes, heart attacks, and||
2075|025|U|kidney problems. Moexipril belongs to a class of drugs known as||
2075|026|U|ACE inhibitors. It works by relaxing blood vessels so blood can||
2075|027|U|flow more easily.||
2075|028|B|||
2075|029|V|OTHER USES:  This section contains uses of this drug that are not||
2075|030|V|listed in the approved professional labeling for the drug but||
2075|031|V|that may be prescribed by your health care professional. Use this||
2075|032|V|drug for a condition that is listed in this section only if it||
2075|033|V|has been so prescribed by your health care professional.||
2075|034|V|   This drug may also be used for heart failure. It may also be||
2075|035|V|used for kidney disease and to help protect the kidneys from harm||
2075|036|V|due to diabetes.||
2075|037|B|||
2075|038|H|HOW TO USE:  Take this medication by mouth on an empty stomach 1||
2075|039|H|hour before a meal as directed by your doctor, usually once or||
2075|040|H|twice daily. The dosage is based on your medical condition and||
2075|041|H|response to treatment.||
2075|042|H|   To reduce your risk of side effects, your doctor may direct||
2075|043|H|you to start this medication at a low dose and gradually increase||
2075|044|H|your dose. Follow your doctor's instructions carefully.||
2075|045|H|   Take this medication regularly to get the most benefit from||
2075|046|H|it. To help you remember, take it at the same time(s) each day.||
2075|047|H|Keep taking this medication even if you feel well. Most people||
2075|048|H|with high blood pressure do not feel sick.||
2075|049|H|   It may take several weeks before you get the full benefit of||
2075|050|H|this drug.||
2075|051|H|   Tell your doctor if your condition does not get better or if||
2075|052|H|it gets worse (your blood pressure readings remain high or||
2075|053|H|increase).||
2075|054|B|||
2075|055|S|SIDE EFFECTS:  Dizziness, lightheadedness, or tiredness may occur||
2075|056|S|as your body adjusts to the medication. Dry cough may also occur.||
2075|057|S|If any of these effects last or get worse, tell your doctor or||
2075|058|S|pharmacist promptly.||
2075|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
2075|060|S|slowly when rising from a sitting or lying position.||
2075|061|S|   Remember that this medication has been prescribed because your||
2075|062|S|doctor has judged that the benefit to you is greater than the||
2075|063|S|risk of side effects. Many people using this medication do not||
2075|064|S|have serious side effects.||
2075|065|S|   Tell your doctor right away if you have any serious side||
2075|066|S|effects, including: symptoms of a high potassium blood level||
2075|067|S|(such as muscle weakness, slow/irregular heartbeat), fainting.||
2075|068|S|   Although moexipril may be used to prevent kidney problems or||
2075|069|S|treat people who have kidney problems, it may also rarely cause||
2075|070|S|kidney problems or make them worse. Your doctor will check your||
2075|071|S|kidney function while you are taking this medication. Tell your||
2075|072|S|doctor right away if you have any signs of kidney problems such||
2075|073|S|as a change in the amount of urine.||
2075|074|S|   This drug may rarely cause serious (possibly fatal) liver||
2075|075|S|problems. Get medical help right away if you have any symptoms of||
2075|076|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
2075|077|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2075|078|S|urine.||
2075|079|S|   A very serious allergic reaction to this drug is rare.||
2075|080|S|However, get medical help right away if you notice any symptoms||
2075|081|S|of a serious allergic reaction, including: rash, itching/swelling||
2075|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2075|083|S|breathing.||
2075|084|S|   This is not a complete list of possible side effects. If you||
2075|085|S|notice other effects not listed above, contact your doctor or||
2075|086|S|pharmacist.||
2075|087|S|   In the US -||
2075|088|S|   Call your doctor for medical advice about side effects. You||
2075|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2075|090|S|www.fda.gov/medwatch.||
2075|091|S|   In Canada - Call your doctor for medical advice about side||
2075|092|S|effects. You may report side effects to Health Canada at||
2075|093|S|1-866-234-2345.||
2075|094|B|||
2075|095|P|PRECAUTIONS:  Before taking moexipril, tell your doctor or||
2075|096|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
2075|097|P|(such as captopril, lisinopril); or if you have any other||
2075|098|P|allergies. This product may contain inactive ingredients, which||
2075|099|P|can cause allergic reactions or other problems. Talk to your||
2075|100|P|pharmacist for more details.||
2075|101|P|   Before using this medication, tell your doctor or pharmacist||
2075|102|P|your medical history, especially of: history of an allergic||
2075|103|P|reaction which included swelling of the face/lips/tongue/throat||
2075|104|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
2075|105|P|dialysis), high level of potassium in the blood, liver disease.||
2075|106|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2075|107|P|can make you more dizzy. Do not drive, use machinery, or do||
2075|108|P|anything that needs alertness until you can do it safely. Limit||
2075|109|P|alcoholic beverages. Talk to your doctor if you are using||
2075|110|P|marijuana (cannabis).||
2075|111|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
2075|112|P|and cause you to feel lightheaded. Tell your doctor if you have||
2075|113|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
2075|114|P|of fluids unless your doctor tells you not to.||
2075|115|P|   This medication may increase your potassium levels. Before||
2075|116|P|using potassium supplements or salt substitutes that contain||
2075|117|P|potassium, consult your doctor or pharmacist.||
2075|118|P|   Before having surgery, tell your doctor or dentist about all||
2075|119|P|the products you use (including prescription drugs,||
2075|120|P|nonprescription drugs, and herbal products).||
2075|121|P|   Older adults may be more sensitive to the side effects of this||
2075|122|P|drug, especially dizziness and high potassium levels.||
2075|123|P|   Tell your doctor if you are pregnant or plan to become||
2075|124|P|pregnant. You should not become pregnant while using moexipril.||
2075|125|P|Moexipril may harm an unborn baby. If you become pregnant, talk||
2075|126|P|to your doctor right away about the risks and benefits of this||
2075|127|P|medication. (See also Warning section.)||
2075|128|P|   It is unknown if moexipril passes into breast milk. Consult||
2075|129|P|your doctor before breastfeeding.||
2075|130|B|||
2075|131|I|DRUG INTERACTIONS:  See also Precautions section.||
2075|132|I|   Drug interactions may change how your medications work or||
2075|133|I|increase your risk for serious side effects. This document does||
2075|134|I|not contain all possible drug interactions. Keep a list of all||
2075|135|I|the products you use (including prescription/nonprescription||
2075|136|I|drugs and herbal products) and share it with your doctor and||
2075|137|I|pharmacist. Do not start, stop, or change the dosage of any||
2075|138|I|medicines without your doctor's approval.||
2075|139|I|   Some products that may interact with this drug include:||
2075|140|I|aliskiren, gold injections, lithium, sacubitril, certain drugs||
2075|141|I|that weaken the immune system/increase the risk of infection||
2075|142|I|(such as everolimus, sirolimus), drugs that may increase the||
2075|143|I|level of potassium in the blood (such as ARBs including||
2075|144|I|losartan/valsartan, birth control pills containing drospirenone).||
2075|145|I|   Some products have ingredients that could raise your blood||
2075|146|I|pressure or worsen your heart failure. Tell your pharmacist what||
2075|147|I|products you are using, and ask how to use them safely||
2075|148|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
2075|149|I|ibuprofen/naproxen).||
2075|150|I|   A very serious reaction may occur if you are getting||
2075|151|I|injections for bee/wasp sting allergy (desensitization) and are||
2075|152|I|also taking moexipril. Make sure all your doctors know which||
2075|153|I|medicines you are using.||
2075|154|B|||
2075|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2075|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2075|157|O|poison control center right away. US residents can call||
2075|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2075|159|O|Symptoms of overdose may include: unusually fast or slow||
2075|160|O|heartbeat, severe dizziness, or fainting.||
2075|161|B|||
2075|162|N|NOTES:  Do not share this medication with others.||
2075|163|N|   Lifestyle changes that may help this medication work better||
2075|164|N|include exercising, stopping smoking, and eating a||
2075|165|N|low-cholesterol/low-fat diet. Consult your doctor for more||
2075|166|N|details.||
2075|167|N|   Lab and/or medical tests (such as kidney function, potassium||
2075|168|N|levels) should be done while you are taking this medication. Keep||
2075|169|N|all medical and lab appointments. Consult your doctor for more||
2075|170|N|details.||
2075|171|N|   Check your blood pressure and pulse (heart rate) regularly||
2075|172|N|while taking this medication. Learn how to check your own blood||
2075|173|N|pressure and pulse at home, and share the results with your||
2075|174|N|doctor.||
2075|175|B|||
2075|176|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2075|177|D|remember. If it is near the time of the next dose, skip the||
2075|178|D|missed dose. Take your next dose at the regular time. Do not||
2075|179|D|double the dose to catch up.||
2075|180|B|||
2075|181|R|STORAGE:  Store at room temperature away from light and moisture.||
2075|182|R|Do not store in the bathroom. Keep all medications away from||
2075|183|R|children and pets.||
2075|184|R|   Do not flush medications down the toilet or pour them into a||
2075|185|R|drain unless instructed to do so. Properly discard this product||
2075|186|R|when it is expired or no longer needed. Consult your pharmacist||
2075|187|R|or local waste disposal company.||
2075|188|B|||
2075|189|A|Information last revised May 2024.||
2075|190|A|Copyright(c) 2025 First Databank, Inc.||
2075|191|B|||
2077|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2077|002|Z|does NOT have all possible information about this product. This||
2077|003|Z|information does not assure that this product is safe, effective,||
2077|004|Z|or appropriate for you. This information is not individual||
2077|005|Z|medical advice and does not substitute for the advice of your||
2077|006|Z|health care professional. Always ask your health care||
2077|007|Z|professional for complete information about this product and your||
2077|008|Z|specific health needs.||
2077|009|B|||
2077|010|T|DAROLUTAMIDE - ORAL||
2077|011|F|(DAR-oh-LOO-ta-mide)||
2077|012|B|||
2077|013|C|COMMON BRAND NAME(S): Nubeqa||
2077|014|B|||
2077|015|U|USES:  Darolutamide is used to treat a certain type of prostate||
2077|016|U|cancer. This medication belongs to a class of drugs known as||
2077|017|U|anti-androgens (anti-testosterone). It works by blocking the||
2077|018|U|effects of testosterone to slow the growth and spread of prostate||
2077|019|U|cancer.||
2077|020|B|||
2077|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2077|022|H|from your pharmacist before you start taking darolutamide and||
2077|023|H|each time you get a refill. If you have any questions, ask your||
2077|024|H|doctor or pharmacist.||
2077|025|H|   Take this medication by mouth with food as directed by your||
2077|026|H|doctor, usually twice daily. Swallow the tablets whole. Do not||
2077|027|H|chew, crush, or split the tablets.||
2077|028|H|   The dosage is based on your medical condition, response to||
2077|029|H|treatment, and other medications you may be taking. Be sure to||
2077|030|H|tell your doctor and pharmacist about all the products you use||
2077|031|H|(including prescription drugs, nonprescription drugs, and herbal||
2077|032|H|products).||
2077|033|H|   Do not increase your dose or take this drug more often than||
2077|034|H|prescribed. Your condition will not improve any faster, and your||
2077|035|H|risk of side effects will increase.||
2077|036|H|   Take this medication regularly to get the most benefit from||
2077|037|H|it. To help you remember, take it at the same times each day.||
2077|038|H|   Since this drug can be absorbed through the skin and lungs and||
2077|039|H|may harm an unborn baby, women who are pregnant or who may become||
2077|040|H|pregnant should not handle this medication or breathe the dust||
2077|041|H|from the tablets.||
2077|042|B|||
2077|043|S|SIDE EFFECTS:  Tiredness, weakness, nausea, or arm/leg/hand/foot||
2077|044|S|pain may occur. If any of these effects last or get worse, tell||
2077|045|S|your doctor or pharmacist promptly.||
2077|046|S|   Remember that this medication has been prescribed because your||
2077|047|S|doctor has judged that the benefit to you is greater than the||
2077|048|S|risk of side effects. Many people using this medication do not||
2077|049|S|have serious side effects.||
2077|050|S|   This medication may raise your blood pressure. Check your||
2077|051|S|blood pressure regularly and tell your doctor if the results are||
2077|052|S|high.||
2077|053|S|   Get medical help right away if you have any very serious side||
2077|054|S|effects, including: symptoms of a heart attack (such as||
2077|055|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
2077|056|S|seizures.||
2077|057|S|   This medication may lower your ability to fight infections.||
2077|058|S|This may make you more likely to get a serious (rarely fatal)||
2077|059|S|infection or make any infection you have worse. Tell your doctor||
2077|060|S|right away if you have any signs of infection (such as sore||
2077|061|S|throat that doesn't go away, fever, chills).||
2077|062|S|   A very serious allergic reaction to this drug is rare.||
2077|063|S|However, get medical help right away if you notice any symptoms||
2077|064|S|of a serious allergic reaction, including: rash, itching/swelling||
2077|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2077|066|S|breathing.||
2077|067|S|   This is not a complete list of possible side effects. If you||
2077|068|S|notice other effects not listed above, contact your doctor or||
2077|069|S|pharmacist.||
2077|070|S|   In the US -||
2077|071|S|   Call your doctor for medical advice about side effects. You||
2077|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2077|073|S|www.fda.gov/medwatch.||
2077|074|S|   In Canada - Call your doctor for medical advice about side||
2077|075|S|effects. You may report side effects to Health Canada at||
2077|076|S|1-866-234-2345.||
2077|077|B|||
2077|078|P|PRECAUTIONS:  Before taking darolutamide, tell your doctor or||
2077|079|P|pharmacist if you are allergic to it; or if you have any other||
2077|080|P|allergies. This product may contain inactive ingredients, which||
2077|081|P|can cause allergic reactions or other problems. Talk to your||
2077|082|P|pharmacist for more details.||
2077|083|P|   Before using this medication, tell your doctor or pharmacist||
2077|084|P|your medical history, especially of: kidney problems, liver||
2077|085|P|problems, heart problems (such as coronary artery disease, recent||
2077|086|P|heart attack), diabetes, high cholesterol, high blood pressure,||
2077|087|P|seizures, increased risk for seizure (such as brain injury,||
2077|088|P|stroke, brain tumor).||
2077|089|P|   Since this medication may rarely cause seizures in some||
2077|090|P|people, ask your doctor if you should avoid activities where a||
2077|091|P|sudden loss of consciousness may cause serious harm to you or||
2077|092|P|others.||
2077|093|P|   Before having surgery, tell your doctor or dentist about all||
2077|094|P|the products you use (including prescription drugs,||
2077|095|P|nonprescription drugs, and herbal products).||
2077|096|P|   This medication can affect fertility in males. Ask your doctor||
2077|097|P|for more details.||
2077|098|P|   Since this drug can be absorbed through the skin and lungs and||
2077|099|P|may harm an unborn baby, women who are pregnant or who may become||
2077|100|P|pregnant should not handle this medication or breathe the dust||
2077|101|P|from the tablets.||
2077|102|P|   This medication should not be used by women, especially during||
2077|103|P|pregnancy or breastfeeding. It may harm an unborn or||
2077|104|P|breastfeeding baby. Consult your doctor for more details.||
2077|105|P|   Men with female partners of childbearing age should use||
2077|106|P|reliable forms of birth control during treatment and for 1 week||
2077|107|P|after stopping treatment. If your partner becomes pregnant or||
2077|108|P|thinks she may be pregnant, tell the doctor right away.||
2077|109|B|||
2077|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2077|111|I|medications work or increase your risk for serious side effects.||
2077|112|I|This document does not contain all possible drug interactions.||
2077|113|I|Keep a list of all the products you use (including||
2077|114|I|prescription/nonprescription drugs and herbal products) and share||
2077|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
2077|116|I|the dosage of any medicines without your doctor's approval.||
2077|117|I|   Other medications can affect the removal of darolutamide from||
2077|118|I|your body, which may affect how darolutamide works. Examples||
2077|119|I|include rifamycins (such as rifabutin, rifampin), drugs to treat||
2077|120|I|seizures (such as carbamazepine, phenobarbital, phenytoin), St.||
2077|121|I|John's wort, among others.||
2077|122|B|||
2077|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2077|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2077|125|O|poison control center right away. US residents can call||
2077|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2077|127|O|Symptoms of overdose may include seizures.||
2077|128|B|||
2077|129|N|NOTES:  Do not share this medication with others.||
2077|130|N|   Lab and/or medical tests (such as PSA levels, blood pressure)||
2077|131|N|should be done while you are taking this medication. Keep all||
2077|132|N|medical and lab appointments.||
2077|133|B|||
2077|134|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2077|135|D|remember. If it is near the time of the next dose, skip the||
2077|136|D|missed dose. Take your next dose at the regular time. Do not||
2077|137|D|double the dose to catch up.||
2077|138|B|||
2077|139|R|STORAGE:  Store at room temperature away from light and moisture.||
2077|140|R|Do not store in the bathroom. Keep all medications away from||
2077|141|R|children and pets.||
2077|142|R|   Do not flush medications down the toilet or pour them into a||
2077|143|R|drain unless instructed to do so. Properly discard this product||
2077|144|R|when it is expired or no longer needed. Consult your pharmacist||
2077|145|R|or local waste disposal company.||
2077|146|B|||
2077|147|A|Information last revised April 2025.||
2077|148|A|Copyright(c) 2025 First Databank, Inc.||
2077|149|B|||
2078|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2078|002|Z|does NOT have all possible information about this product. This||
2078|003|Z|information does not assure that this product is safe, effective,||
2078|004|Z|or appropriate for you. This information is not individual||
2078|005|Z|medical advice and does not substitute for the advice of your||
2078|006|Z|health care professional. Always ask your health care||
2078|007|Z|professional for complete information about this product and your||
2078|008|Z|specific health needs.||
2078|009|B|||
2078|010|T|BREMELANOTIDE - SUBCUTANEOUS INJECTION||
2078|011|F|(BRE-me-LAN-oh-tide)||
2078|012|B|||
2078|013|C|COMMON BRAND NAME(S): Vyleesi||
2078|014|B|||
2078|015|U|USES:  This medication is used to treat women who have not gone||
2078|016|U|through menopause who have low sexual desire and are concerned||
2078|017|U|about it.||
2078|018|U|   Bremelanotide should not be used to treat low sexual desire||
2078|019|U|caused by a medical or mental/mood disorder, problems in a||
2078|020|U|relationship, or the effects of other drugs. This medication||
2078|021|U|should not be used by women who have gone through menopause, or||
2078|022|U|by men. Bremelanotide is not used to enhance sexual performance.||
2078|023|B|||
2078|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
2078|025|H|Instructions for Use if available from your pharmacist before you||
2078|026|H|start using bremelanotide and each time you get a refill. Ask||
2078|027|H|your health care professional how to prepare and use this||
2078|028|H|medication. If you have any questions, ask your doctor or||
2078|029|H|pharmacist.||
2078|030|H|   Inject this medication under the skin as directed by your||
2078|031|H|doctor, usually as needed. The injection is given in the abdomen||
2078|032|H|or thigh. Use each injection at least 45 minutes before you think||
2078|033|H|you will begin sexual activity. Do not use more than 1 dose in 24||
2078|034|H|hours. Do not use more than 8 doses each month. Doing so may||
2078|035|H|increase your risk of side effects (such as darkening of the||
2078|036|H|skin, high blood pressure).||
2078|037|H|   Before using, check this product for particles or||
2078|038|H|discoloration. If either is present, do not use the liquid.||
2078|039|H|Before injecting each dose, clean the skin you are going to||
2078|040|H|inject into (the injection site) with rubbing alcohol. Change the||
2078|041|H|injection site each time to lessen injury under the skin. Do not||
2078|042|H|inject into skin that is irritated, sore, bruised, red, hard, or||
2078|043|H|scarred. To lessen bruising, do not rub the injection site after||
2078|044|H|a shot. Learn how to store and discard medical supplies safely.||
2078|045|H|   Tell your doctor if your condition does not get better or if||
2078|046|H|it gets worse.||
2078|047|B|||
2078|048|S|SIDE EFFECTS:  Nausea, vomiting, flushing, headache, or dizziness||
2078|049|S|may occur. Redness/irritation/pain at the injection site may also||
2078|050|S|occur. If any of these effects last or get worse, tell your||
2078|051|S|doctor or pharmacist promptly. If you have severe nausea that||
2078|052|S|does not go away, your doctor may prescribe an anti-nausea||
2078|053|S|medicine for you.||
2078|054|S|   This medication may cause darkening of the skin on certain||
2078|055|S|areas of your body (such as the face, gums, and breast). People||
2078|056|S|with darker skin color may be at higher risk. It is unknown if||
2078|057|S|this effect is permanent. Tell your health care provider if you||
2078|058|S|have any concerns about changes to your skin.||
2078|059|S|   Remember that this medication has been prescribed because your||
2078|060|S|doctor has judged that the benefit to you is greater than the||
2078|061|S|risk of side effects. Many people using this medication do not||
2078|062|S|have serious side effects.||
2078|063|S|   This medication may cause a temporary increase in blood||
2078|064|S|pressure and decrease in heart rate after each injection. This||
2078|065|S|effect will usually go away within 12 hours after the dose. Check||
2078|066|S|your blood pressure regularly and tell your doctor if the results||
2078|067|S|are high.||
2078|068|S|   A very serious allergic reaction to this drug is rare.||
2078|069|S|However, get medical help right away if you notice any symptoms||
2078|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2078|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2078|072|S|breathing.||
2078|073|S|   This is not a complete list of possible side effects. If you||
2078|074|S|notice other effects not listed above, contact your doctor or||
2078|075|S|pharmacist.||
2078|076|S|   In the US -||
2078|077|S|   Call your doctor for medical advice about side effects. You||
2078|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2078|079|S|www.fda.gov/medwatch.||
2078|080|S|   In Canada - Call your doctor for medical advice about side||
2078|081|S|effects. You may report side effects to Health Canada at||
2078|082|S|1-866-234-2345.||
2078|083|B|||
2078|084|P|PRECAUTIONS:  Before using bremelanotide, tell your doctor or||
2078|085|P|pharmacist if you are allergic to it; or if you have any other||
2078|086|P|allergies. This product may contain inactive ingredients, which||
2078|087|P|can cause allergic reactions or other problems. Talk to your||
2078|088|P|pharmacist for more details.||
2078|089|P|   Before using this medication, tell your doctor or pharmacist||
2078|090|P|your medical history, especially of: high blood pressure, heart||
2078|091|P|problems, kidney problems, liver problems.||
2078|092|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2078|093|P|can make you more dizzy. Do not drive, use machinery, or do||
2078|094|P|anything that needs alertness until you can do it safely. Limit||
2078|095|P|alcoholic beverages. Talk to your doctor if you are using||
2078|096|P|marijuana (cannabis).||
2078|097|P|   Before having surgery, tell your doctor or dentist about all||
2078|098|P|the products you use (including prescription drugs,||
2078|099|P|nonprescription drugs, and herbal products).||
2078|100|P|   During pregnancy, this medication should be used only when||
2078|101|P|clearly needed. Ask about reliable forms of birth control while||
2078|102|P|using this medication. If you become pregnant, talk to your||
2078|103|P|doctor right away about the risks and benefits of this||
2078|104|P|medication.||
2078|105|P|   It is unknown if this medication passes into breast milk.||
2078|106|P|Consult your doctor before breastfeeding.||
2078|107|B|||
2078|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2078|109|I|medications work or increase your risk for serious side effects.||
2078|110|I|This document does not contain all possible drug interactions.||
2078|111|I|Keep a list of all the products you use (including||
2078|112|I|prescription/nonprescription drugs and herbal products) and share||
2078|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
2078|114|I|the dosage of any medicines without your doctor's approval.||
2078|115|B|||
2078|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2078|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2078|118|O|poison control center right away. US residents can call||
2078|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2078|120|B|||
2078|121|N|NOTES:  Do not share this medication with others.||
2078|122|N|   Lab and/or medical tests (such as blood pressure) should be||
2078|123|N|done while you are using this medication. Keep all medical and||
2078|124|N|lab appointments.||
2078|125|B|||
2078|126|D|MISSED DOSE:  Not applicable.||
2078|127|B|||
2078|128|R|STORAGE:  Store at room temperature away from light. Do not||
2078|129|R|freeze. Keep all medications away from children and pets.||
2078|130|R|   Do not flush medications down the toilet or pour them into a||
2078|131|R|drain unless instructed to do so. Properly discard this product||
2078|132|R|when it is expired or no longer needed. Consult your pharmacist||
2078|133|R|or local waste disposal company.||
2078|134|B|||
2078|135|A|Information last revised December 2024.||
2078|136|A|Copyright(c) 2025 First Databank, Inc.||
2078|137|B|||
2079|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2079|002|Z|does NOT have all possible information about this product. This||
2079|003|Z|information does not assure that this product is safe, effective,||
2079|004|Z|or appropriate for you. This information is not individual||
2079|005|Z|medical advice and does not substitute for the advice of your||
2079|006|Z|health care professional. Always ask your health care||
2079|007|Z|professional for complete information about this product and your||
2079|008|Z|specific health needs.||
2079|009|B|||
2079|010|T|PEXIDARTINIB - ORAL||
2079|011|F|(PEX-i-Dar-ti-nib)||
2079|012|B|||
2079|013|C|COMMON BRAND NAME(S): Turalio||
2079|014|B|||
2079|015|W|WARNING:  Pexidartinib may rarely cause serious (possibly fatal)||
2079|016|W|liver disease. Careful monitoring by your doctor may decrease||
2079|017|W|your risk. Your doctor will check liver tests before you start||
2079|018|W|taking this medication and regularly during treatment (usually||
2079|019|W|every week for the first 8 weeks, then every 2 weeks for one||
2079|020|W|month, then every 3 months). Based on your results, your doctor||
2079|021|W|may check lab tests more often. Tell your doctor right away if||
2079|022|W|you develop symptoms such as nausea/vomiting that doesn't stop,||
2079|023|W|loss of appetite, stomach/abdominal pain, yellowing eyes/skin,||
2079|024|W|dark urine.||
2079|025|W|   To receive pexidartinib in the United States, you must||
2079|026|W|understand, agree to, and carefully follow the requirements of||
2079|027|W|the REMS Program for this medication. If you live in Canada or||
2079|028|W|any other country, consult your doctor and pharmacist for your||
2079|029|W|country's regulations.||
2079|030|B|||
2079|031|U|USES:  This medication is used to treat a certain type of tumor||
2079|032|U|(tenosynovial giant cell tumor) that is not likely to improve||
2079|033|U|with surgery. Pexidartinib belongs to a class of drugs known as||
2079|034|U|kinase inhibitors. It works by slowing or stopping the growth of||
2079|035|U|certain tumor cells.||
2079|036|B|||
2079|037|H|HOW TO USE:  Read the Medication Guide provided by your||
2079|038|H|pharmacist before you start taking pexidartinib and each time you||
2079|039|H|get a refill. If you have any questions, ask your doctor or||
2079|040|H|pharmacist.||
2079|041|H|   Take this medication by mouth with a low fat meal (about 11 to||
2079|042|H|14 grams of total fat) as directed by your doctor, usually twice||
2079|043|H|daily. Swallow the capsules whole. Do not open, break, or chew||
2079|044|H|the capsules. Do not take this medication with a high fat meal||
2079|045|H|since this increases the risk of side effects.||
2079|046|H|   The dosage is based on your medical condition, response to||
2079|047|H|treatment, and other medications you may be taking. Be sure to||
2079|048|H|tell your doctor and pharmacist about all the products you use||
2079|049|H|(including prescription drugs, nonprescription drugs, and herbal||
2079|050|H|products).||
2079|051|H|   Take this medication regularly to get the most benefit from||
2079|052|H|it. To help you remember, take it at the same times each day.||
2079|053|H|   If you vomit after taking a dose, do not take another dose.||
2079|054|H|Take your next dose at the regular time.||
2079|055|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2079|056|H|using this medication unless your doctor or pharmacist says you||
2079|057|H|may do so safely. Grapefruit can increase the chance of side||
2079|058|H|effects with this medicine. Ask your doctor or pharmacist for||
2079|059|H|more details.||
2079|060|H|   Medications that reduce stomach acid (such as antacids, proton||
2079|061|H|pump inhibitors/PPIs, H2 blockers) may make pexidartinib work||
2079|062|H|less well. Do not take PPIs (such as lansoprazole, omeprazole)||
2079|063|H|while using this medication. If you take antacids, take||
2079|064|H|pexidartinib 2 hours before or 2 hours after taking the antacid.||
2079|065|H|If you take H2 blockers (such as famotidine, nizatidine), take||
2079|066|H|pexidartinib at least 2 hours before or 10 hours after taking the||
2079|067|H|H2 blocker.||
2079|068|H|   Do not increase your dose or use this drug more often or for||
2079|069|H|longer than prescribed. Your condition will not improve any||
2079|070|H|faster, and your risk of serious side effects will increase.||
2079|071|H|   Since this drug can be absorbed through the skin and lungs and||
2079|072|H|may harm an unborn baby, women who are pregnant or who may become||
2079|073|H|pregnant should not handle this medication or breathe the dust||
2079|074|H|from the capsules.||
2079|075|B|||
2079|076|S|SIDE EFFECTS:  See also Warning section.||
2079|077|S|   Nausea, vomiting, constipation, itching, tiredness, changes in||
2079|078|S|hair color, loss of taste, or changes in how food tastes may||
2079|079|S|occur. If any of these effects last or get worse, tell your||
2079|080|S|doctor or pharmacist promptly.||
2079|081|S|   People using this medication may have serious side effects.||
2079|082|S|However, you have been prescribed this drug because your doctor||
2079|083|S|has judged that the benefit to you is greater than the risk of||
2079|084|S|side effects. Careful monitoring by your doctor may decrease your||
2079|085|S|risk.||
2079|086|S|   Tell your doctor right away if you have any serious side||
2079|087|S|effects, including: swelling around your eyes/eyelids, vision||
2079|088|S|changes (such as blurred vision, decreased vision),||
2079|089|S|numbness/tingling, swelling arms/legs/feet.||
2079|090|S|   This medication may lower your ability to fight infections.||
2079|091|S|This may make you more likely to get a serious (rarely fatal)||
2079|092|S|infection or make any infection you have worse. Tell your doctor||
2079|093|S|right away if you have any signs of infection (such as sore||
2079|094|S|throat that doesn't go away, fever, chills).||
2079|095|S|   Pexidartinib can commonly cause a mild rash that is usually||
2079|096|S|not serious. However, you may not be able to tell it apart from a||
2079|097|S|rare rash that could be a sign of a severe allergic reaction. Get||
2079|098|S|medical help right away if you develop any rash.||
2079|099|S|   A very serious allergic reaction to this drug is rare.||
2079|100|S|However, get medical help right away if you notice any symptoms||
2079|101|S|of a serious allergic reaction, including: rash, itching/swelling||
2079|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2079|103|S|breathing.||
2079|104|S|   This is not a complete list of possible side effects. If you||
2079|105|S|notice other effects not listed above, contact your doctor or||
2079|106|S|pharmacist.||
2079|107|S|   In the US -||
2079|108|S|   Call your doctor for medical advice about side effects. You||
2079|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2079|110|S|www.fda.gov/medwatch.||
2079|111|S|   In Canada - Call your doctor for medical advice about side||
2079|112|S|effects. You may report side effects to Health Canada at||
2079|113|S|1-866-234-2345.||
2079|114|B|||
2079|115|P|PRECAUTIONS:  Before taking pexidartinib, tell your doctor or||
2079|116|P|pharmacist if you are allergic to it; or if you have any other||
2079|117|P|allergies. This product may contain inactive ingredients, which||
2079|118|P|can cause allergic reactions or other problems. Talk to your||
2079|119|P|pharmacist for more details.||
2079|120|P|   Before using this medication, tell your doctor or pharmacist||
2079|121|P|your medical history, especially of: kidney problems, liver||
2079|122|P|problems.||
2079|123|P|   Pexidartinib can make you more likely to get infections or may||
2079|124|P|make current infections worse. Stay away from anyone who has an||
2079|125|P|infection that may easily spread (such as chickenpox, COVID-19,||
2079|126|P|measles, flu). Talk to your doctor if you have been exposed to an||
2079|127|P|infection or for more details.||
2079|128|P|   Tell your health care professional that you are using||
2079|129|P|pexidartinib before having any immunizations/vaccinations. Avoid||
2079|130|P|contact with people who have recently received live vaccines||
2079|131|P|(such as flu vaccine inhaled through the nose).||
2079|132|P|   This drug may cause blurred vision. Do not drive, use||
2079|133|P|machinery, or do anything that needs clear vision until you can||
2079|134|P|do it safely.||
2079|135|P|   This medication may make you more sensitive to the sun. Limit||
2079|136|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2079|137|P|sunscreen and wear protective clothing when outdoors. Tell your||
2079|138|P|doctor right away if you get sunburned or have skin||
2079|139|P|blisters/redness.||
2079|140|P|   Before having surgery, tell your doctor or dentist about all||
2079|141|P|the products you use (including prescription drugs,||
2079|142|P|nonprescription drugs, and herbal products).||
2079|143|P|   This medication can affect fertility in both males and||
2079|144|P|females. Ask your doctor for more details.||
2079|145|P|   Since this drug can be absorbed through the skin and lungs and||
2079|146|P|may harm an unborn baby, women who are pregnant or who may become||
2079|147|P|pregnant should not handle this medication or breathe the dust||
2079|148|P|from the capsules.||
2079|149|P|   Tell your doctor if you are pregnant or plan to become||
2079|150|P|pregnant. You should not become pregnant while using||
2079|151|P|pexidartinib. Pexidartinib may harm an unborn baby. Your doctor||
2079|152|P|should order a pregnancy test before you start this medication.||
2079|153|P|Women using this medication should ask about reliable forms of||
2079|154|P|birth control during treatment and for 1 month after the last||
2079|155|P|dose. Men using this medication should ask about reliable forms||
2079|156|P|of birth control during treatment and for 1 week after the last||
2079|157|P|dose. If you or your partner becomes pregnant, talk to your||
2079|158|P|doctor right away about the risks and benefits of this||
2079|159|P|medication.||
2079|160|P|   It is unknown if this drug passes into breast milk. Because of||
2079|161|P|the possible risk to the infant, breastfeeding is not recommended||
2079|162|P|while using this drug and for at least 1 week after your last||
2079|163|P|dose. Consult your doctor before breastfeeding.||
2079|164|B|||
2079|165|I|DRUG INTERACTIONS:  See also How to Use section.||
2079|166|I|   Drug interactions may change how your medications work or||
2079|167|I|increase your risk for serious side effects. This document does||
2079|168|I|not contain all possible drug interactions. Keep a list of all||
2079|169|I|the products you use (including prescription/nonprescription||
2079|170|I|drugs and herbal products) and share it with your doctor and||
2079|171|I|pharmacist. Do not start, stop, or change the dosage of any||
2079|172|I|medicines without your doctor's approval.||
2079|173|I|   Other medications can affect the removal of pexidartinib from||
2079|174|I|your body, which may affect how pexidartinib works. Examples||
2079|175|I|include rifamycins (such as rifabutin, rifampin), St. John's||
2079|176|I|wort, drugs used to treat seizures (such as carbamazepine,||
2079|177|I|phenytoin), among others.||
2079|178|I|   This medication can speed up the removal of other medications||
2079|179|I|from your body, which may affect how they work. Examples of||
2079|180|I|affected drugs include elacestrant, mavacamten, quizartinib,||
2079|181|I|revumenib, among others.||
2079|182|I|   This medication may decrease the effectiveness of hormonal||
2079|183|I|birth control such as pills, patch, or ring. This could cause||
2079|184|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2079|185|I|use reliable backup birth control methods while using this||
2079|186|I|medication. Also tell your doctor if you have any new spotting or||
2079|187|I|breakthrough bleeding, because these may be signs that your birth||
2079|188|I|control is not working well.||
2079|189|B|||
2079|190|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2079|191|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2079|192|O|poison control center right away. US residents can call||
2079|193|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2079|194|B|||
2079|195|N|NOTES:  Do not share this medication with others.||
2079|196|N|   Lab and/or medical tests (such as kidney/liver function,||
2079|197|N|cholesterol, complete blood count) should be done while you are||
2079|198|N|taking this medication. Keep all medical and lab appointments.||
2079|199|B|||
2079|200|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2079|201|D|remember. If it is near the time of the next dose, skip the||
2079|202|D|missed dose. Take your next dose at the regular time. Do not||
2079|203|D|double the dose to catch up.||
2079|204|B|||
2079|205|R|STORAGE:  Store at room temperature away from light and moisture.||
2079|206|R|Do not store in the bathroom. Keep the drying agent (desiccant)||
2079|207|R|in the container. Tightly close the container when not in use.||
2079|208|R|Keep all medications away from children and pets.||
2079|209|R|   Do not flush medications down the toilet or pour them into a||
2079|210|R|drain unless instructed to do so. Properly discard this product||
2079|211|R|when it is expired or no longer needed. Consult your pharmacist||
2079|212|R|or local waste disposal company.||
2079|213|B|||
2079|214|A|Information last revised June 2025.||
2079|215|A|Copyright(c) 2025 First Databank, Inc.||
2079|216|B|||
2082|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2082|002|Z|does NOT have all possible information about this product. This||
2082|003|Z|information does not assure that this product is safe, effective,||
2082|004|Z|or appropriate for you. This information is not individual||
2082|005|Z|medical advice and does not substitute for the advice of your||
2082|006|Z|health care professional. Always ask your health care||
2082|007|Z|professional for complete information about this product and your||
2082|008|Z|specific health needs.||
2082|009|B|||
2082|010|T|UPADACITINIB EXTENDED-RELEASE - ORAL||
2082|011|F|(ue-PAD-a-SYE-ti-nib)||
2082|012|B|||
2082|013|C|COMMON BRAND NAME(S): Rinvoq||
2082|014|B|||
2082|015|W|WARNING:  Upadacitinib may lower your ability to fight||
2082|016|W|infections. This may make you more likely to get a serious||
2082|017|W|(rarely fatal) infection or make any infection you have worse.||
2082|018|W|The most common serious infections include pneumonia and skin||
2082|019|W|infections. The risk for infections may be higher if you also||
2082|020|W|take other drugs that suppress the immune system (such as||
2082|021|W|methotrexate, corticosteroids). Tell your doctor right away if||
2082|022|W|you have any signs of infection (such as a sore throat that||
2082|023|W|doesn't go away, fever, chills, cough, non-healing skin sores,||
2082|024|W|painful/frequent urination, white patches in your mouth or on||
2082|025|W|your tongue).||
2082|026|W|   You should have a tuberculosis (TB) skin test before and||
2082|027|W|during treatment with this medication. Tell your doctor if you||
2082|028|W|have been near someone with tuberculosis or have lived or||
2082|029|W|traveled in areas where certain fungal infections (such as||
2082|030|W|coccidioidomycosis, histoplasmosis) are common. These areas||
2082|031|W|include the Ohio and Mississippi River valleys and the||
2082|032|W|southwestern United States.||
2082|033|W|   Though it is very unlikely to occur, there may be a risk of||
2082|034|W|developing cancer (such as lymphoma, skin cancer, lung cancer)||
2082|035|W|with this medication. Your risk may be higher if you are a||
2082|036|W|current or past smoker. Protect your skin from the sun. Avoid||
2082|037|W|prolonged sun exposure, tanning booths, and sunlamps. Use a||
2082|038|W|sunscreen and wear protective clothing when outdoors. Tell your||
2082|039|W|doctor right away if you develop symptoms such as fever or cough||
2082|040|W|that doesn't go away, wheezing, unusual lumps/growths,||
2082|041|W|unexplained weight loss, night sweats, change in appearance or||
2082|042|W|size of moles, or unusual skin changes.||
2082|043|W|   Upadacitinib may rarely cause serious (possibly fatal)||
2082|044|W|problems from blood clots (such as heart attack, stroke, blood||
2082|045|W|clots in the lungs or legs). You may be at an increased risk for||
2082|046|W|blood clots if you are a current or past smoker, or are 50 years||
2082|047|W|of age or older and have at least one risk factor for heart||
2082|048|W|disease. Discuss the risks and benefits of treatment with your||
2082|049|W|doctor. Get medical help right away if any of these side effects||
2082|050|W|occur: shortness of breath/rapid breathing, chest/jaw/left arm||
2082|051|W|pain, unusual sweating, confusion, sudden dizziness/fainting,||
2082|052|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2082|053|W|trouble speaking, weakness on one side of the body, or sudden||
2082|054|W|vision changes.||
2082|055|B|||
2082|056|U|USES:  Upadacitinib is used to treat certain types of arthritis||
2082|057|U|(such as psoriatic arthritis, rheumatoid arthritis, axial||
2082|058|U|spondyloarthritis, polyarticular juvenile idiopathic arthritis-||
2082|059|U|pJIA). It helps decrease pain, tenderness, and swelling in the||
2082|060|U|joints. This medication can also be used to treat giant cell||
2082|061|U|arteritis. It helps to reduce swelling in your blood vessels so||
2082|062|U|blood can flow more easily. Upadacitinib is also used to treat a||
2082|063|U|skin condition called atopic dermatitis. It reduces swelling,||
2082|064|U|itching, and redness in the skin. This medication may also be||
2082|065|U|used to treat certain bowel diseases (Crohn's disease, ulcerative||
2082|066|U|colitis). It helps to reduce symptoms such as diarrhea and||
2082|067|U|stomach pain.||
2082|068|B|||
2082|069|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2082|070|H|Patient Information Leaflet provided by your pharmacist before||
2082|071|H|you start taking upadacitinib and each time you get a refill. If||
2082|072|H|you have any questions, ask your doctor or pharmacist.||
2082|073|H|   Take this medication by mouth with or without food as directed||
2082|074|H|by your doctor, usually once daily. Do not crush, chew, or split||
2082|075|H|the tablets. Doing so can release all of the drug at once,||
2082|076|H|increasing the risk of side effects.||
2082|077|H|   Use this medication regularly to get the most benefit from it.||
2082|078|H|To help you remember, take it at the same time each day.||
2082|079|H|   The dosage is based on your medical condition, response to||
2082|080|H|treatment, age, weight, and other medications you may be taking.||
2082|081|H|Be sure to tell your doctor and pharmacist about all the products||
2082|082|H|you use (including prescription drugs, nonprescription drugs, and||
2082|083|H|herbal products).||
2082|084|H|   Do not increase your dose or use this drug more often or for||
2082|085|H|longer than prescribed. Your condition will not improve any||
2082|086|H|faster, and your risk of side effects will increase.||
2082|087|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2082|088|H|using this medication unless your doctor or pharmacist says you||
2082|089|H|may do so safely. Grapefruit can increase the chance of side||
2082|090|H|effects with this medicine. Ask your doctor or pharmacist for||
2082|091|H|more details.||
2082|092|H|   Tell your doctor if your condition does not get better or if||
2082|093|H|it gets worse.||
2082|094|B|||
2082|095|S|SIDE EFFECTS:  See also Warning section.||
2082|096|S|   Nausea or headache may occur. If either of these effects lasts||
2082|097|S|or gets worse, tell your doctor or pharmacist promptly.||
2082|098|S|   You may rarely see a tablet or partial tablets in your stool.||
2082|099|S|This may occur if you have certain intestinal disorders (such as||
2082|100|S|ileostomy, colostomy). Tell your doctor right away if you see||
2082|101|S|tablets in your stool.||
2082|102|S|   People using this medication may have serious side effects.||
2082|103|S|However, you have been prescribed this drug because your doctor||
2082|104|S|has judged that the benefit to you is greater than the risk of||
2082|105|S|side effects. Careful monitoring by your doctor may decrease your||
2082|106|S|risk.||
2082|107|S|   Tell your doctor right away if you have any serious side||
2082|108|S|effects, including: signs of anemia (such as unusual tiredness,||
2082|109|S|pale skin, fast heartbeat), signs of liver disease (such as||
2082|110|S|nausea/vomiting that doesn't stop, loss of appetite,||
2082|111|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2082|112|S|of a serious tear in the stomach or intestinal wall (such as||
2082|113|S|severe stomach/abdominal pain that doesn't go away, fever, severe||
2082|114|S|dizziness, fainting, severe nausea/vomiting).||
2082|115|S|   Get medical help right away if you have any very serious side||
2082|116|S|effects, including: sudden vision changes (such as blurred||
2082|117|S|vision, seeing flashes of light).||
2082|118|S|   A very serious allergic reaction to this drug is rare.||
2082|119|S|However, get medical help right away if you notice any symptoms||
2082|120|S|of a serious allergic reaction, including: rash, itching/swelling||
2082|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2082|122|S|breathing.||
2082|123|S|   This is not a complete list of possible side effects. If you||
2082|124|S|notice other effects not listed above, contact your doctor or||
2082|125|S|pharmacist.||
2082|126|S|   In the US -||
2082|127|S|   Call your doctor for medical advice about side effects. You||
2082|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2082|129|S|www.fda.gov/medwatch.||
2082|130|S|   In Canada - Call your doctor for medical advice about side||
2082|131|S|effects. You may report side effects to Health Canada at||
2082|132|S|1-866-234-2345.||
2082|133|B|||
2082|134|P|PRECAUTIONS:  See also Warning section.||
2082|135|P|   Before taking upadacitinib, tell your doctor or pharmacist if||
2082|136|P|you are allergic to it; or if you have any other allergies. This||
2082|137|P|product may contain inactive ingredients, which can cause||
2082|138|P|allergic reactions or other problems. Talk to your pharmacist for||
2082|139|P|more details.||
2082|140|P|   Before using this medication, tell your doctor or pharmacist||
2082|141|P|your medical history, especially of: blood clots (such as in the||
2082|142|P|lungs, legs), blood/bone marrow problems (such as anemia),||
2082|143|P|cancer, heart problems (such as previous heart attack), liver||
2082|144|P|disease (such as hepatitis B or C), past/recent/current||
2082|145|P|infections (such as tuberculosis, herpes zoster, HIV infection),||
2082|146|P|current or past smoking, stomach/intestinal problems (such as||
2082|147|P|ulcers, diverticulitis), stroke, kidney disease.||
2082|148|P|   Upadacitinib can make you more likely to get infections or may||
2082|149|P|make current infections worse. Stay away from anyone who has an||
2082|150|P|infection that may easily spread (such as chickenpox, COVID-19,||
2082|151|P|measles, flu). Talk to your doctor if you have been exposed to an||
2082|152|P|infection or for more details.||
2082|153|P|   Tell your health care professional that you are using||
2082|154|P|upadacitinib before having any immunizations/vaccinations. Avoid||
2082|155|P|contact with people who have recently received live vaccines||
2082|156|P|(such as flu vaccine inhaled through the nose).||
2082|157|P|   Before having surgery, tell your doctor or dentist about all||
2082|158|P|the products you use (including prescription drugs,||
2082|159|P|nonprescription drugs, and herbal products).||
2082|160|P|   Older adults may be at greater risk for side effects while||
2082|161|P|using this drug.||
2082|162|P|   Tell your doctor if you are pregnant or plan to become||
2082|163|P|pregnant. You should not become pregnant while using||
2082|164|P|upadacitinib. Upadacitinib may harm an unborn baby. Your doctor||
2082|165|P|should order a pregnancy test before you start this medication.||
2082|166|P|Ask about reliable forms of birth control while using this||
2082|167|P|medication and for 4 weeks after the last dose. If you become||
2082|168|P|pregnant, talk to your doctor right away about the risks and||
2082|169|P|benefits of this medication.||
2082|170|P|   It is unknown if this medication passes into breast milk.||
2082|171|P|Because of the possible risk to the infant, breastfeeding is not||
2082|172|P|recommended while using this medication and for 6 days after the||
2082|173|P|last dose. Consult your doctor before breastfeeding.||
2082|174|B|||
2082|175|I|DRUG INTERACTIONS:  See also How to Use section.||
2082|176|I|   Drug interactions may change how your medications work or||
2082|177|I|increase your risk for serious side effects. This document does||
2082|178|I|not contain all possible drug interactions. Keep a list of all||
2082|179|I|the products you use (including prescription/nonprescription||
2082|180|I|drugs and herbal products) and share it with your doctor and||
2082|181|I|pharmacist. Do not start, stop, or change the dosage of any||
2082|182|I|medicines without your doctor's approval.||
2082|183|I|   Other medications can affect the removal of upadacitinib from||
2082|184|I|your body, which may affect how upadacitinib works. Examples||
2082|185|I|include rifampin, phenytoin, among others.||
2082|186|B|||
2082|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2082|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2082|189|O|poison control center right away. US residents can call||
2082|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2082|191|B|||
2082|192|N|NOTES:  Do not share this medication with others.||
2082|193|N|   Lab and/or medical tests (such as liver function, complete||
2082|194|N|blood count, cholesterol levels, skin exams) should be done while||
2082|195|N|you are taking this medication. Keep all medical and lab||
2082|196|N|appointments.||
2082|197|B|||
2082|198|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2082|199|D|remember. If it is near the time of the next dose, skip the||
2082|200|D|missed dose. Take your next dose at the regular time. Do not||
2082|201|D|double the dose to catch up.||
2082|202|B|||
2082|203|R|STORAGE:  Store in the original bottle in the refrigerator or at||
2082|204|R|room temperature away from light and moisture. Do not store in||
2082|205|R|the bathroom. Keep all medications away from children and pets.||
2082|206|R|   Do not flush medications down the toilet or pour them into a||
2082|207|R|drain unless instructed to do so. Properly discard this product||
2082|208|R|when it is expired or no longer needed. Consult your pharmacist||
2082|209|R|or local waste disposal company.||
2082|210|B|||
2082|211|M|MEDICAL ALERT:  Your condition can cause complications in a||
2082|212|M|medical emergency. For information about enrolling in MedicAlert,||
2082|213|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2082|214|B|||
2082|215|A|Information last revised April 2025.||
2082|216|A|Copyright(c) 2025 First Databank, Inc.||
2082|217|B|||
2083|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2083|002|Z|does NOT have all possible information about this product. This||
2083|003|Z|information does not assure that this product is safe, effective,||
2083|004|Z|or appropriate for you. This information is not individual||
2083|005|Z|medical advice and does not substitute for the advice of your||
2083|006|Z|health care professional. Always ask your health care||
2083|007|Z|professional for complete information about this product and your||
2083|008|Z|specific health needs.||
2083|009|B|||
2083|010|T|CROMOLYN LIQUID - ORAL||
2083|011|F|(CROW-mow-lin)||
2083|012|B|||
2083|013|C|COMMON BRAND NAME(S): Gastrocrom||
2083|014|B|||
2083|015|U|USES:  This medication is used to treat mastocytosis, a disease||
2083|016|U|that occurs when the body has too many mast cells. These normal||
2083|017|U|body cells release substances (such as histamines) that are||
2083|018|U|needed for normal body defense and healing, but when too many||
2083|019|U|mast cells are present, they release too much of these||
2083|020|U|substances. This can lead to symptoms such as diarrhea,||
2083|021|U|stomach/abdominal pain, itching, rash, and flushing. Cromolyn||
2083|022|U|belongs to a class of medications called mast cell stabilizers.||
2083|023|U|It works by preventing mast cells from releasing the substances||
2083|024|U|that can cause these skin and gut problems.||
2083|025|B|||
2083|026|V|OTHER USES:  This section contains uses of this drug that are not||
2083|027|V|listed in the approved professional labeling for the drug but||
2083|028|V|that may be prescribed by your health care professional. Use this||
2083|029|V|drug for a condition that is listed in this section only if it||
2083|030|V|has been so prescribed by your health care professional.||
2083|031|V|   This drug may also be used reduce the risk of food allergies.||
2083|032|V|It may also be used for other intestinal problems such as||
2083|033|V|inflammatory bowel disease.||
2083|034|B|||
2083|035|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2083|036|H|from your pharmacist before you start using cromolyn and each||
2083|037|H|time you get a refill. If you have any questions, ask your doctor||
2083|038|H|or pharmacist.||
2083|039|H|   Take this medication by mouth as directed by your doctor,||
2083|040|H|usually 4 times daily (30 minutes before meals and at bedtime).||
2083|041|H|If you are using this drug to prevent a food allergy or for||
2083|042|H|inflammatory bowel disease, your doctor may direct you to take it||
2083|043|H|15 to 20 minutes before meals. The dosage is based on your||
2083|044|H|medical condition and response to treatment.||
2083|045|H|   Do not swallow the ampules. The contents of the ampules are||
2083|046|H|used to make a solution. Before using, check this product for||
2083|047|H|particles or discoloration. If either is present, do not use the||
2083|048|H|liquid. To make the solution, break open the ampule(s) and||
2083|049|H|squeeze the liquid into a glass of water. Do not mix with fruit||
2083|050|H|juice, soda, milk, or any fluid except plain water. Stir the||
2083|051|H|solution well. Drink all of the solution right away. Do not mix||
2083|052|H|it ahead of time. Do not take the ampules out of their foil pouch||
2083|053|H|until right before using.||
2083|054|H|   This medication does not work right away. You need to use this||
2083|055|H|medication regularly to get the most benefit from it. To help you||
2083|056|H|remember, take it at the same times each day. It may take 2-3||
2083|057|H|weeks before you see a benefit from this medication. Your doctor||
2083|058|H|may change your dose to find the best dose for you.||
2083|059|H|   Do not use this form of cromolyn for inhalation (such as in a||
2083|060|H|nebulizer), in the nose, or by injection. It is for oral use||
2083|061|H|(swallowing) only. It does not work to treat breathing problems,||
2083|062|H|nasal/seasonal allergies, or other allergic reactions.||
2083|063|H|   Tell your doctor if your symptoms do not get better or if they||
2083|064|H|get worse.||
2083|065|B|||
2083|066|S|SIDE EFFECTS:  Headache, muscle aches, and diarrhea may occur. If||
2083|067|S|any of these effects last or get worse, tell your doctor or||
2083|068|S|pharmacist promptly.||
2083|069|S|   Remember that this medication has been prescribed because your||
2083|070|S|doctor has judged that the benefit to you is greater than the||
2083|071|S|risk of side effects. Many people using this medication do not||
2083|072|S|have serious side effects.||
2083|073|S|   A very serious allergic reaction to this drug is rare.||
2083|074|S|However, get medical help right away if you notice any symptoms||
2083|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2083|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2083|077|S|breathing.||
2083|078|S|   This is not a complete list of possible side effects. If you||
2083|079|S|notice other effects not listed above, contact your doctor or||
2083|080|S|pharmacist.||
2083|081|S|   In the US -||
2083|082|S|   Call your doctor for medical advice about side effects. You||
2083|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2083|084|S|www.fda.gov/medwatch.||
2083|085|S|   In Canada - Call your doctor for medical advice about side||
2083|086|S|effects. You may report side effects to Health Canada at||
2083|087|S|1-866-234-2345.||
2083|088|B|||
2083|089|P|PRECAUTIONS:  Before taking cromolyn, tell your doctor or||
2083|090|P|pharmacist if you are allergic to it; or if you have any other||
2083|091|P|allergies. This product may contain inactive ingredients, which||
2083|092|P|can cause allergic reactions or other problems. Talk to your||
2083|093|P|pharmacist for more details.||
2083|094|P|   Before using this medication, tell your doctor or pharmacist||
2083|095|P|your medical history, especially of: kidney disease, liver||
2083|096|P|disease.||
2083|097|P|   Before having surgery, tell your doctor or dentist about all||
2083|098|P|the products you use (including prescription drugs,||
2083|099|P|nonprescription drugs, and herbal products).||
2083|100|P|   During pregnancy, this medication should be used only when||
2083|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
2083|102|P|   It is unknown if this drug passes into breast milk. Consult||
2083|103|P|your doctor before breastfeeding.||
2083|104|B|||
2083|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2083|106|I|medications work or increase your risk for serious side effects.||
2083|107|I|This document does not contain all possible drug interactions.||
2083|108|I|Keep a list of all the products you use (including||
2083|109|I|prescription/nonprescription drugs and herbal products) and share||
2083|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
2083|111|I|the dosage of any medicines without your doctor's approval.||
2083|112|B|||
2083|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2083|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2083|115|O|poison control center right away. US residents can call||
2083|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2083|117|B|||
2083|118|N|NOTES:  Do not share this medication with others.||
2083|119|B|||
2083|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2083|121|D|remember. If you have already had your meal, skip the missed||
2083|122|D|dose. Take your next dose at the regular time. Do not double the||
2083|123|D|dose to catch up.||
2083|124|B|||
2083|125|R|STORAGE:  Store at room temperature away from light. Keep the||
2083|126|R|ampules in their foil pouches until ready for use. Keep all||
2083|127|R|medications away from children and pets.||
2083|128|R|   Do not flush medications down the toilet or pour them into a||
2083|129|R|drain unless instructed to do so. Properly discard this product||
2083|130|R|when it is expired or no longer needed. Consult your pharmacist||
2083|131|R|or local waste disposal company.||
2083|132|B|||
2083|133|A|Information last revised November 2024.||
2083|134|A|Copyright(c) 2025 First Databank, Inc.||
2083|135|B|||
2085|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2085|002|Z|does NOT have all possible information about this product. This||
2085|003|Z|information does not assure that this product is safe, effective,||
2085|004|Z|or appropriate for you. This information is not individual||
2085|005|Z|medical advice and does not substitute for the advice of your||
2085|006|Z|health care professional. Always ask your health care||
2085|007|Z|professional for complete information about this product and your||
2085|008|Z|specific health needs.||
2085|009|B|||
2085|010|T|SODIUM CHLORIDE - ORAL||
2085|011|F|(SOE-dee-um KLOR-ide)||
2085|012|B|||
2085|013|U|USES:  This product is used to supply water and salt (sodium||
2085|014|U|chloride) to the body. It may also be used to prevent heat cramps||
2085|015|U|due to excessive sweating.||
2085|016|U|   Check the ingredients on the label even if you have used the||
2085|017|U|product before. The manufacturer may have changed the||
2085|018|U|ingredients. Also, products with similar names may contain||
2085|019|U|different ingredients meant for different purposes. Taking the||
2085|020|U|wrong product could harm you.||
2085|021|B|||
2085|022|H|HOW TO USE:  Follow all directions on the product package. If||
2085|023|H|your doctor has prescribed this medication, take it as directed.||
2085|024|H|If you have any questions, ask your doctor or pharmacist.||
2085|025|H|   Take this medication by mouth as directed by your doctor. The||
2085|026|H|tablet may be swallowed whole or dissolved in water and the||
2085|027|H|solution then swallowed. If you are dissolving the tablet, mix it||
2085|028|H|in half a glass of distilled water (4 ounces/120 milliliters). Do||
2085|029|H|not increase your dose or use this drug more often or for longer||
2085|030|H|than directed.||
2085|031|H|   If your heat cramps do not get better after 1 day (24 hours),||
2085|032|H|or if any of your symptoms get worse, or if you think you may||
2085|033|H|have a serious medical problem, get medical help right away.||
2085|034|B|||
2085|035|S|SIDE EFFECTS:  If your doctor has directed you to use this||
2085|036|S|medication, remember that your doctor has judged that the benefit||
2085|037|S|to you is greater than the risk of side effects. Many people||
2085|038|S|using this medication do not have serious side effects.||
2085|039|S|   Tell your doctor right away if you have any serious side||
2085|040|S|effects, including: swelling of hands/ankle/feet.||
2085|041|S|   A very serious allergic reaction to this drug is rare.||
2085|042|S|However, get medical help right away if you notice any symptoms||
2085|043|S|of a serious allergic reaction, including: rash, itching/swelling||
2085|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2085|045|S|breathing.||
2085|046|S|   This is not a complete list of possible side effects. If you||
2085|047|S|notice other effects not listed above, contact your doctor or||
2085|048|S|pharmacist.||
2085|049|S|   In the US -||
2085|050|S|   Call your doctor for medical advice about side effects. You||
2085|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2085|052|S|www.fda.gov/medwatch.||
2085|053|S|   In Canada - Call your doctor for medical advice about side||
2085|054|S|effects. You may report side effects to Health Canada at||
2085|055|S|1-866-234-2345.||
2085|056|B|||
2085|057|P|PRECAUTIONS:  Before taking sodium chloride, tell your doctor or||
2085|058|P|pharmacist if you are allergic to it; or if you have any other||
2085|059|P|allergies. This product may contain inactive ingredients, which||
2085|060|P|can cause allergic reactions or other problems. Talk to your||
2085|061|P|pharmacist for more details.||
2085|062|P|   If you have any of the following health problems, consult your||
2085|063|P|doctor or pharmacist before using this medication: kidney||
2085|064|P|problems, heart problems (such as heart failure), high blood||
2085|065|P|pressure, any other condition that requires a salt-restricted||
2085|066|P|diet.||
2085|067|P|   Before having surgery, tell your doctor or dentist about all||
2085|068|P|the products you use (including prescription drugs,||
2085|069|P|nonprescription drugs, and herbal products).||
2085|070|P|   Sodium chloride is safe to use during pregnancy or while||
2085|071|P|breastfeeding when used as directed. Consult your doctor or||
2085|072|P|pharmacist for more details.||
2085|073|B|||
2085|074|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2085|075|I|medications work or increase your risk for serious side effects.||
2085|076|I|This document does not contain all possible drug interactions.||
2085|077|I|Keep a list of all the products you use (including||
2085|078|I|prescription/nonprescription drugs and herbal products) and share||
2085|079|I|it with your doctor and pharmacist. Do not start, stop, or change||
2085|080|I|the dosage of any medicines without your doctor's approval.||
2085|081|B|||
2085|082|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2085|083|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2085|084|O|poison control center right away. US residents can call||
2085|085|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2085|086|B|||
2085|087|N|NOTES:  Keep all medical and lab appointments.||
2085|088|N|   Lab tests (such as sodium blood levels) may be done while you||
2085|089|N|are taking this medication. Keep all medical and lab||
2085|090|N|appointments. Consult your doctor for more details.||
2085|091|B|||
2085|092|D|MISSED DOSE:  If you are taking this medication on a regular||
2085|093|D|schedule and miss a dose, take it as soon as you remember. If it||
2085|094|D|is near the time of the next dose, skip the missed dose. Take||
2085|095|D|your next dose at the regular time. Do not double the dose to||
2085|096|D|catch up.||
2085|097|B|||
2085|098|R|STORAGE:  Store at room temperature away from light and moisture.||
2085|099|R|Do not store in the bathroom. Keep all medications away from||
2085|100|R|children and pets.||
2085|101|R|   Do not flush medications down the toilet or pour them into a||
2085|102|R|drain unless instructed to do so. Properly discard this product||
2085|103|R|when it is expired or no longer needed. Consult your pharmacist||
2085|104|R|or local waste disposal company.||
2085|105|B|||
2085|106|A|Information last revised February 2025.||
2085|107|A|Copyright(c) 2025 First Databank, Inc.||
2085|108|B|||
2086|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2086|002|Z|does NOT have all possible information about this product. This||
2086|003|Z|information does not assure that this product is safe, effective,||
2086|004|Z|or appropriate for you. This information is not individual||
2086|005|Z|medical advice and does not substitute for the advice of your||
2086|006|Z|health care professional. Always ask your health care||
2086|007|Z|professional for complete information about this product and your||
2086|008|Z|specific health needs.||
2086|009|B|||
2086|010|T|ENTRECTINIB - ORAL||
2086|011|F|(en-TREK-ti-nib)||
2086|012|B|||
2086|013|C|COMMON BRAND NAME(S): Rozlytrek||
2086|014|B|||
2086|015|U|USES:  This medication is used to treat various types of cancer.||
2086|016|U|Entrectinib belongs to a class of drugs known as kinase||
2086|017|U|inhibitors. It works by slowing or stopping the growth of cancer||
2086|018|U|cells.||
2086|019|B|||
2086|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
2086|021|H|Instructions for Use if available from your pharmacist before you||
2086|022|H|start taking entrectinib and each time you get a refill. If you||
2086|023|H|have any questions, ask your doctor or pharmacist.||
2086|024|H|   Take this medication by mouth with or without food as directed||
2086|025|H|by your doctor, usually once daily.||
2086|026|H|   If you are taking the capsules, swallow whole. Do not crush or||
2086|027|H|chew the capsules.||
2086|028|H|   If you have trouble swallowing the capsules, or if you are||
2086|029|H|prescribed a certain dose, your doctor may direct you to open a||
2086|030|H|prescribed number of capsule(s) and mix the contents with||
2086|031|H|room-temperature water or milk to make a suspension. Ask your||
2086|032|H|doctor or pharmacist how much water or milk you should use to mix||
2086|033|H|the capsule(s). Let the suspension sit for 15 minutes, then||
2086|034|H|carefully measure the prescribed dose using a special measuring||
2086|035|H|device/spoon. Do not use a household spoon because you may not||
2086|036|H|get the correct dose. Take the suspension right away, then drink||
2086|037|H|water to make sure you have swallowed all of the prescribed dose.||
2086|038|H|In some cases, your doctor may direct you to mix more medication||
2086|039|H|than you need for a dose. Always follow your doctor's directions||
2086|040|H|for how to mix your medication, but do not take more of the||
2086|041|H|suspension than your doctor tells you to take. Discard any unused||
2086|042|H|suspension, or any suspension that has not been used within 2||
2086|043|H|hours after preparation.||
2086|044|H|   The suspension may also be given through a tube into the||
2086|045|H|stomach (nasogastric or gastric tube). If you are giving this||
2086|046|H|medication through a nasogastric or gastric tube, ask your health||
2086|047|H|care professional for detailed instructions on how to give it.||
2086|048|H|   If you are using the pellet form of this medication, open the||
2086|049|H|packet(s) and sprinkle the entire contents of each packet on one||
2086|050|H|or more spoonful(s) of soft food (such as applesauce, yogurt,||
2086|051|H|pudding). Take the mixture right away. To avoid a bitter taste,||
2086|052|H|do not crush or chew the pellets. Drink water after taking to||
2086|053|H|make sure the entire dose is taken. If you are unable to take the||
2086|054|H|pellets sprinkled on soft food within 20 minutes, throw away the||
2086|055|H|mixture and prepare a new dose. Do not use the pellets to make a||
2086|056|H|suspension. Do not give the pellets through a feeding tube.||
2086|057|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2086|058|H|using this medication unless your doctor or pharmacist says you||
2086|059|H|may do so safely. Grapefruit can increase the chance of side||
2086|060|H|effects with this medicine. Ask your doctor or pharmacist for||
2086|061|H|more details.||
2086|062|H|   The dosage is based on your medical condition, response to||
2086|063|H|treatment, age, lab tests, and other medications you may be||
2086|064|H|taking. Be sure to tell your doctor and pharmacist about all the||
2086|065|H|products you use (including prescription drugs, nonprescription||
2086|066|H|drugs, and herbal products). Children's dosage is also based on||
2086|067|H|body size.||
2086|068|H|   Take this medication regularly to get the most benefit from||
2086|069|H|it. To help you remember, take it at the same time each day.||
2086|070|H|   If you vomit right after taking a dose, you may take another||
2086|071|H|dose.||
2086|072|H|   Do not increase your dose or use this drug more often or for||
2086|073|H|longer than prescribed. Your condition will not improve any||
2086|074|H|faster, and your risk of serious side effects will increase.||
2086|075|H|   Since this drug can be absorbed through the skin and lungs and||
2086|076|H|may harm an unborn baby, women who are pregnant or who may become||
2086|077|H|pregnant should not handle this medication or breathe the dust||
2086|078|H|from the capsules or pellets.||
2086|079|B|||
2086|080|S|SIDE EFFECTS:  Nausea, vomiting, tiredness, constipation,||
2086|081|S|dizziness, drowsiness, sleep problems, headache, diarrhea,||
2086|082|S|muscle/joint pain, unusual changes in sense of touch, or changes||
2086|083|S|in how food tastes may occur. If any of these effects last or get||
2086|084|S|worse, tell your doctor or pharmacist promptly.||
2086|085|S|   People using this medication may have serious side effects.||
2086|086|S|However, you have been prescribed this drug because your doctor||
2086|087|S|has judged that the benefit to you is greater than the risk of||
2086|088|S|side effects. Careful monitoring by your doctor may decrease your||
2086|089|S|risk.||
2086|090|S|   Tell your doctor right away if you have any serious side||
2086|091|S|effects, including: mental/mood changes (such as confusion,||
2086|092|S|anxiety, depression, trouble paying attention, memory problems),||
2086|093|S|numbness/tingling, vision changes (such as blurred/double vision,||
2086|094|S|decreased vision), eyes being sensitive to light, signs of heart||
2086|095|S|failure (such as shortness of breath, swelling ankles/feet,||
2086|096|S|unusual/sudden weight gain), signs of liver problems (such as||
2086|097|S|nausea/vomiting that doesn't stop, loss of appetite,||
2086|098|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2086|099|S|   Get medical help right away if you have any very serious side||
2086|100|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2086|101|S|fainting.||
2086|102|S|   This medication may increase your risk for bone fractures.||
2086|103|S|Fractures may happen with or without a fall or injury. Tell your||
2086|104|S|health care provider right away if you have bone pain or changes||
2086|105|S|in movement.||
2086|106|S|   This medication may cause your blood uric acid levels to||
2086|107|S|increase. Your doctor will check uric acid levels regularly||
2086|108|S|during treatment, and may adjust your dose of entrectinib. You||
2086|109|S|may also be prescribed other medication to treat high uric acid||
2086|110|S|levels.||
2086|111|S|   This medication may lower your ability to fight infections.||
2086|112|S|This may make you more likely to get a serious (rarely fatal)||
2086|113|S|infection or make any infection you have worse. Tell your doctor||
2086|114|S|right away if you have any signs of infection (such as sore||
2086|115|S|throat that doesn't go away, fever, chills).||
2086|116|S|   A very serious allergic reaction to this drug is rare.||
2086|117|S|However, get medical help right away if you notice any symptoms||
2086|118|S|of a serious allergic reaction, including: rash, itching/swelling||
2086|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2086|120|S|breathing.||
2086|121|S|   This is not a complete list of possible side effects. If you||
2086|122|S|notice other effects not listed above, contact your doctor or||
2086|123|S|pharmacist.||
2086|124|S|   In the US -||
2086|125|S|   Call your doctor for medical advice about side effects. You||
2086|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2086|127|S|www.fda.gov/medwatch.||
2086|128|S|   In Canada - Call your doctor for medical advice about side||
2086|129|S|effects. You may report side effects to Health Canada at||
2086|130|S|1-866-234-2345.||
2086|131|B|||
2086|132|P|PRECAUTIONS:  Before taking entrectinib, tell your doctor or||
2086|133|P|pharmacist if you are allergic to it; or if you have any other||
2086|134|P|allergies. This product may contain inactive ingredients, which||
2086|135|P|can cause allergic reactions or other problems. Talk to your||
2086|136|P|pharmacist for more details.||
2086|137|P|   Before using this medication, tell your doctor or pharmacist||
2086|138|P|your medical history, especially of: kidney problems, liver||
2086|139|P|problems, eye/vision problems.||
2086|140|P|   This drug may make you dizzy or drowsy or cause blurred||
2086|141|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
2086|142|P|or drowsy. Do not drive, use machinery, or do anything that needs||
2086|143|P|alertness or clear vision until you can do it safely. Limit||
2086|144|P|alcoholic beverages. Talk to your doctor if you are using||
2086|145|P|marijuana (cannabis).||
2086|146|P|   Entrectinib may cause a condition that affects the heart||
2086|147|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2086|148|P|serious (rarely fatal) fast/irregular heartbeat and other||
2086|149|P|symptoms (such as severe dizziness, fainting) that need medical||
2086|150|P|attention right away.||
2086|151|P|   The risk of QT prolongation may be increased if you have||
2086|152|P|certain medical conditions or are taking other drugs that may||
2086|153|P|cause QT prolongation. Before using entrectinib, tell your doctor||
2086|154|P|or pharmacist of all the drugs you take and if you have any of||
2086|155|P|the following conditions: heart problems (such as heart failure,||
2086|156|P|previous heart attack, slow heartbeat, QT prolongation in the||
2086|157|P|EKG), family history of certain heart problems (QT prolongation||
2086|158|P|in the EKG, sudden cardiac death).||
2086|159|P|   Low levels of potassium or magnesium in the blood may also||
2086|160|P|increase your risk of QT prolongation. This risk may increase if||
2086|161|P|you use certain drugs (such as diuretics/"water pills") or if you||
2086|162|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2086|163|P|   Entrectinib can make you more likely to get infections or may||
2086|164|P|make current infections worse. Stay away from anyone who has an||
2086|165|P|infection that may easily spread (such as chickenpox, COVID-19,||
2086|166|P|measles, flu). Talk to your doctor if you have been exposed to an||
2086|167|P|infection or for more details.||
2086|168|P|   Tell your health care professional that you are using||
2086|169|P|entrectinib before having any immunizations/vaccinations. Avoid||
2086|170|P|contact with people who have recently received live vaccines||
2086|171|P|(such as flu vaccine inhaled through the nose).||
2086|172|P|   Before having surgery, tell your doctor or dentist about all||
2086|173|P|the products you use (including prescription drugs,||
2086|174|P|nonprescription drugs, and herbal products).||
2086|175|P|   Older adults may be more sensitive to the side effects of this||
2086|176|P|drug, especially QT prolongation (see above).||
2086|177|P|   Since this drug can be absorbed through the skin and lungs and||
2086|178|P|may harm an unborn baby, women who are pregnant or who may become||
2086|179|P|pregnant should not handle this medication or breathe the dust||
2086|180|P|from the capsules or pellets.||
2086|181|P|   Tell your doctor if you are pregnant or plan to become||
2086|182|P|pregnant. You should not become pregnant while using entrectinib.||
2086|183|P|Entrectinib may harm an unborn baby. Your doctor should order a||
2086|184|P|pregnancy test before you start this medication. Women using this||
2086|185|P|medication should ask about reliable forms of birth control||
2086|186|P|during treatment and for at least 5 weeks after the last dose.||
2086|187|P|Men using this medication should ask about reliable forms of||
2086|188|P|birth control during treatment and for 3 months after the last||
2086|189|P|dose. If you or your partner becomes pregnant, talk to your||
2086|190|P|doctor right away about the risks and benefits of this||
2086|191|P|medication.||
2086|192|P|   It is unknown if this medication passes into breast milk.||
2086|193|P|Because of the possible risk to the infant, breastfeeding is not||
2086|194|P|recommended while using this medication and for 7 days after the||
2086|195|P|last dose. Consult your doctor before breastfeeding.||
2086|196|B|||
2086|197|I|DRUG INTERACTIONS:  See also How to Use section.||
2086|198|I|   Drug interactions may change how your medications work or||
2086|199|I|increase your risk for serious side effects. This document does||
2086|200|I|not contain all possible drug interactions. Keep a list of all||
2086|201|I|the products you use (including prescription/nonprescription||
2086|202|I|drugs and herbal products) and share it with your doctor and||
2086|203|I|pharmacist. Do not start, stop, or change the dosage of any||
2086|204|I|medicines without your doctor's approval.||
2086|205|I|   Other medications can affect the removal of entrectinib from||
2086|206|I|your body, which may affect how entrectinib works. Examples||
2086|207|I|include azole antifungals (such as fluconazole, itraconazole),||
2086|208|I|macrolide antibiotics (such as clarithromycin), HIV protease||
2086|209|I|inhibitors (such as nelfinavir), rifamycins (such as rifabutin,||
2086|210|I|rifampin), ritonavir, St. John's wort, drugs used to treat||
2086|211|I|seizures (such as carbamazepine, phenytoin), among others.||
2086|212|B|||
2086|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2086|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2086|215|O|poison control center right away. US residents can call||
2086|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2086|217|B|||
2086|218|N|NOTES:  Do not share this medication with others.||
2086|219|N|   Lab and/or medical tests (such as complete blood count, uric||
2086|220|N|acid, kidney/liver/heart function, EKG) should be done while you||
2086|221|N|are taking this medication. Keep all medical and lab||
2086|222|N|appointments.||
2086|223|B|||
2086|224|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2086|225|D|remember. If it is less than 12 hours before the next dose, skip||
2086|226|D|the missed dose. Take your next dose at the regular time. Do not||
2086|227|D|double the dose to catch up.||
2086|228|B|||
2086|229|R|STORAGE:  See also How to Use section.||
2086|230|R|   Store in the original container at room temperature away from||
2086|231|R|light and moisture. Do not store in the bathroom. Keep all||
2086|232|R|medications away from children and pets.||
2086|233|R|   Do not flush medications down the toilet or pour them into a||
2086|234|R|drain unless instructed to do so. Properly discard this product||
2086|235|R|when it is expired or no longer needed. Consult your pharmacist||
2086|236|R|or local waste disposal company.||
2086|237|B|||
2086|238|M|MEDICAL ALERT:  Your condition can cause complications in a||
2086|239|M|medical emergency. For information about enrolling in MedicAlert,||
2086|240|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2086|241|B|||
2086|242|A|Information last revised April 2025.||
2086|243|A|Copyright(c) 2025 First Databank, Inc.||
2086|244|B|||
2087|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2087|002|Z|does NOT have all possible information about this product. This||
2087|003|Z|information does not assure that this product is safe, effective,||
2087|004|Z|or appropriate for you. This information is not individual||
2087|005|Z|medical advice and does not substitute for the advice of your||
2087|006|Z|health care professional. Always ask your health care||
2087|007|Z|professional for complete information about this product and your||
2087|008|Z|specific health needs.||
2087|009|B|||
2087|010|T|CARISOPRODOL/ASPIRIN - ORAL||
2087|011|F|(kar-iss-oh-PRO-dole/AS-pir-in)||
2087|012|B|||
2087|013|C|COMMON BRAND NAME(S): Soma Compound||
2087|014|B|||
2087|015|U|USES:  This product is used short-term to treat muscle pain and||
2087|016|U|discomfort. It is usually used along with rest, physical therapy,||
2087|017|U|and other treatments. Carisoprodol helps to relax the muscles.||
2087|018|U|Aspirin helps to decrease pain and swelling.||
2087|019|B|||
2087|020|H|HOW TO USE:  Take this medication by mouth with or without food||
2087|021|H|as directed by your doctor. Do not increase your dose or use this||
2087|022|H|drug more often or for longer than prescribed. Your condition||
2087|023|H|will not improve any faster, and your risk of side effects will||
2087|024|H|increase. Take this medication with a full glass of water (8||
2087|025|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
2087|026|H|Do not lie down for at least 10 minutes after taking this||
2087|027|H|medication. If you have stomach upset while taking this||
2087|028|H|medication, take it with food or milk.||
2087|029|H|   The dosage is based on your medical condition and response to||
2087|030|H|treatment. This medication should only be used short-term (for 3||
2087|031|H|weeks or less) unless directed by your doctor. Use the smallest||
2087|032|H|effective dose.||
2087|033|H|   Pain medications work best if they are used as the first signs||
2087|034|H|of pain occur. If you wait until the symptoms have worsened, the||
2087|035|H|medication may not work as well.||
2087|036|H|   If you suddenly stop using this medication, you may have||
2087|037|H|withdrawal symptoms (such as stomach cramps, trouble sleeping,||
2087|038|H|headache, nausea). To help prevent withdrawal, your doctor may||
2087|039|H|lower your dose slowly. Withdrawal is more likely if you have||
2087|040|H|used this medication for a long time or in high doses. Tell your||
2087|041|H|doctor or pharmacist right away if you have withdrawal.||
2087|042|H|   Though it helps many people, this medication may sometimes||
2087|043|H|cause addiction. This risk may be higher if you have a substance||
2087|044|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2087|045|H|Take this medication exactly as prescribed to lower the risk of||
2087|046|H|addiction. Ask your doctor or pharmacist for more details.||
2087|047|H|   Tell your doctor if your condition lasts after 2 to 3 weeks or||
2087|048|H|if it gets worse.||
2087|049|B|||
2087|050|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, stomach upset,||
2087|051|S|nausea/vomiting, or heartburn may occur. If any of these effects||
2087|052|S|last or get worse, tell your doctor or pharmacist promptly.||
2087|053|S|   Remember that this medication has been prescribed because your||
2087|054|S|doctor has judged that the benefit to you is greater than the||
2087|055|S|risk of side effects. Many people using this medication do not||
2087|056|S|have serious side effects.||
2087|057|S|   Tell your doctor right away if you have any serious side||
2087|058|S|effects, including: nausea/vomiting that doesn't stop, easy||
2087|059|S|bruising/bleeding, dark urine, yellowing eyes/skin, hearing||
2087|060|S|problems (such as ringing in the ears, hearing loss), signs of||
2087|061|S|kidney problems (such as change in the amount of urine),||
2087|062|S|fast/pounding heartbeat, unusual tiredness, confusion.||
2087|063|S|   This drug may rarely cause serious (rarely fatal) bleeding||
2087|064|S|from the stomach or intestines. If you notice any of the||
2087|065|S|following unlikely but serious side effects, stop taking this||
2087|066|S|medication and consult your doctor or pharmacist right away:||
2087|067|S|stomach/abdominal pain that doesn't go away, black stool, vomit||
2087|068|S|that looks like coffee grounds.||
2087|069|S|   A very serious allergic reaction to this drug is rare.||
2087|070|S|However, get medical help right away if you notice any symptoms||
2087|071|S|of a serious allergic reaction, including: fever, swollen lymph||
2087|072|S|nodes, rash, itching/swelling (especially of the||
2087|073|S|face/tongue/throat), severe dizziness, trouble breathing.||
2087|074|S|   This is not a complete list of possible side effects. If you||
2087|075|S|notice other effects not listed above, contact your doctor or||
2087|076|S|pharmacist.||
2087|077|S|   In the US -||
2087|078|S|   Call your doctor for medical advice about side effects. You||
2087|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2087|080|S|www.fda.gov/medwatch.||
2087|081|S|   In Canada - Call your doctor for medical advice about side||
2087|082|S|effects. You may report side effects to Health Canada at||
2087|083|S|1-866-234-2345.||
2087|084|B|||
2087|085|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2087|086|P|pharmacist if you are allergic to carisoprodol or aspirin; or to||
2087|087|P|meprobamate, tybamate, or mebutamate; or to nonsteroidal||
2087|088|P|anti-inflammatory drugs-NSAIDs (such as ibuprofen); or to other||
2087|089|P|salicylates (such as choline salicylate); or if you have any||
2087|090|P|other allergies. This product may contain inactive ingredients,||
2087|091|P|which can cause allergic reactions or other problems. Talk to||
2087|092|P|your pharmacist for more details.||
2087|093|P|   Before using this medication, tell your doctor or pharmacist||
2087|094|P|your medical history, especially of: a certain blood disorder||
2087|095|P|(acute intermittent porphyria), asthma (including a history of||
2087|096|P|worsening breathing with runny/stuffy nose after taking aspirin||
2087|097|P|or other NSAIDs), growths in the nose (nasal polyps),||
2087|098|P|stomach/intestine/esophagus problems (such as bleeding,||
2087|099|P|heartburn, ulcers), bleeding/clotting disorders (such as||
2087|100|P|hemophilia, von Willebrand disease, thrombocytopenia), personal||
2087|101|P|or family history of a substance use disorder (such as overuse of||
2087|102|P|or addiction to drugs/alcohol), kidney disease, liver disease,||
2087|103|P|seizure, certain enzyme deficiencies (such as G6PD or pyruvate||
2087|104|P|kinase deficiency), gout.||
2087|105|P|   Before having surgery, tell your doctor or dentist about all||
2087|106|P|the products you use (including prescription drugs,||
2087|107|P|nonprescription drugs, and herbal products).||
2087|108|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2087|109|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2087|110|P|machinery, or do anything that needs alertness until you can do||
2087|111|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2087|112|P|are using marijuana (cannabis).||
2087|113|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
2087|114|P|and tobacco, especially when combined with this medicine, may||
2087|115|P|increase your risk for stomach bleeding. Avoid alcohol and stop||
2087|116|P|smoking. Consult your doctor or pharmacist for more information.||
2087|117|P|   This medication contains aspirin. Children and teenagers less||
2087|118|P|than 18 years old should not take aspirin if they have||
2087|119|P|chickenpox, flu, or any undiagnosed illness or if they have||
2087|120|P|recently received a vaccine. In these cases, taking aspirin||
2087|121|P|increases the risk of Reye's syndrome, a rare but serious||
2087|122|P|illness.||
2087|123|P|   Older adults may be more sensitive to the side effects of this||
2087|124|P|drug, especially drowsiness, confusion, stomach/intestinal||
2087|125|P|bleeding, and ulcers. Drowsiness and confusion can increase the||
2087|126|P|risk of falling.||
2087|127|P|   Before using this medication, women of childbearing age should||
2087|128|P|talk with their doctor(s) about the benefits and risks. Tell your||
2087|129|P|doctor if you are pregnant or if you plan to become pregnant.||
2087|130|P|This medication may harm an unborn baby and cause problems with||
2087|131|P|normal labor/delivery. It is not recommended for use in pregnancy||
2087|132|P|from 20 weeks until delivery. If your doctor decides that you||
2087|133|P|need to use this medication between 20 and 30 weeks of pregnancy,||
2087|134|P|you should use the lowest effective dose for the shortest||
2087|135|P|possible time. You should not use this medication after 30 weeks||
2087|136|P|of pregnancy.||
2087|137|P|   This medication passes into breast milk and may have||
2087|138|P|undesirable effects on a nursing infant. Breastfeeding is not||
2087|139|P|recommended while using this medication. Consult your doctor||
2087|140|P|before breastfeeding.||
2087|141|B|||
2087|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2087|143|I|medications work or increase your risk for serious side effects.||
2087|144|I|This document does not contain all possible drug interactions.||
2087|145|I|Keep a list of all the products you use (including||
2087|146|I|prescription/nonprescription drugs and herbal products) and share||
2087|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
2087|148|I|the dosage of any medicines without your doctor's approval.||
2087|149|I|   Some products that may interact with this drug include:||
2087|150|I|corticosteroids (such as prednisone), mifepristone.||
2087|151|I|   This medication may increase the risk of bleeding when taken||
2087|152|I|with other drugs that also may cause bleeding. Examples include||
2087|153|I|anti-platelet drugs such as clopidogrel/ticagrelor, "blood||
2087|154|I|thinners" such as dabigatran/enoxaparin/warfarin, among others.||
2087|155|I|   Check all prescription and nonprescription medicine labels||
2087|156|I|carefully since many medications contain pain relievers/fever||
2087|157|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
2087|158|I|naproxen). These drugs are similar to this medication and may||
2087|159|I|increase your risk of side effects if taken together. Ask your||
2087|160|I|doctor or pharmacist for more details.||
2087|161|I|   Tell your doctor or pharmacist if you are taking other||
2087|162|I|products that cause drowsiness such as opioid pain or cough||
2087|163|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2087|164|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2087|165|I|lorazepam, zolpidem), other muscle relaxants (such as||
2087|166|I|cyclobenzaprine, methocarbamol), or antihistamines (such as||
2087|167|I|cetirizine, diphenhydramine).||
2087|168|I|   Check the labels on all your medicines (such as allergy or||
2087|169|I|cough-and-cold products) because they may contain ingredients||
2087|170|I|that cause drowsiness. Ask your pharmacist about using those||
2087|171|I|products safely.||
2087|172|B|||
2087|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2087|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2087|175|O|poison control center right away. US residents can call||
2087|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2087|177|O|Symptoms of overdose may include: ringing in ears, severe||
2087|178|O|drowsiness/dizziness, seizures, slow/shallow breathing,||
2087|179|O|mental/mood changes (such as confusion, hallucinations),||
2087|180|O|inability to move your legs/arms, shaky/unsteady movement, vision||
2087|181|O|changes (such as blurred vision).||
2087|182|B|||
2087|183|N|NOTES:  Do not share this medication with others. Sharing it is||
2087|184|N|against the law.||
2087|185|N|   This medication has been prescribed for your current condition||
2087|186|N|only. Do not use it later for another condition unless your||
2087|187|N|doctor directs you to do so. A different medication may be||
2087|188|N|necessary in that case.||
2087|189|B|||
2087|190|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2087|191|D|remember. If it is near the time of the next dose, skip the||
2087|192|D|missed dose. Take your next dose at the regular time. Do not||
2087|193|D|double the dose to catch up.||
2087|194|B|||
2087|195|R|STORAGE:  Store at room temperature away from light and moisture.||
2087|196|R|Do not store in the bathroom. Keep all medications away from||
2087|197|R|children and pets.||
2087|198|R|   Do not flush medications down the toilet or pour them into a||
2087|199|R|drain unless instructed to do so. Properly discard this product||
2087|200|R|when it is expired or no longer needed. Consult your pharmacist||
2087|201|R|or local waste disposal company.||
2087|202|B|||
2087|203|A|Information last revised May 2024.||
2087|204|A|Copyright(c) 2025 First Databank, Inc.||
2087|205|B|||
2088|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2088|002|Z|does NOT have all possible information about this product. This||
2088|003|Z|information does not assure that this product is safe, effective,||
2088|004|Z|or appropriate for you. This information is not individual||
2088|005|Z|medical advice and does not substitute for the advice of your||
2088|006|Z|health care professional. Always ask your health care||
2088|007|Z|professional for complete information about this product and your||
2088|008|Z|specific health needs.||
2088|009|B|||
2088|010|T|TOBRAMYCIN/DEXAMETHASONE SUSPENSION - OPHTHALMIC||
2088|011|F|(TOE-bra-MYE-sin/dex-uh-METH-uh-sown)||
2088|012|B|||
2088|013|C|COMMON BRAND NAME(S): Tobradex, Tobradex ST||
2088|014|B|||
2088|015|U|USES:  This medication is used to treat or prevent eye||
2088|016|U|infections. This medication contains two drugs. Tobramycin||
2088|017|U|belongs to a class of drugs called aminoglycoside antibiotics. It||
2088|018|U|works by stopping the growth of bacteria. Dexamethasone belongs||
2088|019|U|to a class of drugs called corticosteroids. It works by reducing||
2088|020|U|swelling.||
2088|021|U|   This medication treats/prevents only bacterial eye infections.||
2088|022|U|It will not work for other types of eye infections. Unnecessary||
2088|023|U|use or overuse of any antibiotic can lead to its decreased||
2088|024|U|effectiveness.||
2088|025|B|||
2088|026|H|HOW TO USE:  Use this medication in the affected eye(s) as||
2088|027|H|directed by your doctor, usually every 4 to 6 hours.||
2088|028|H|   To apply eye drops, wash your hands first. To avoid||
2088|029|H|contamination, do not touch the dropper tip or let it touch your||
2088|030|H|eye or any other surface. Shake the bottle well before each dose.||
2088|031|H|   Do not wear contact lenses while you are using this medicine.||
2088|032|H|Sterilize contact lenses according to manufacturer's directions||
2088|033|H|and check with your doctor before you begin using them again.||
2088|034|H|   Tilt your head back, look upward, and pull down the lower||
2088|035|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2088|036|H|and place one drop into the pouch. Look downward and gently close||
2088|037|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
2088|038|H|your eye (near the nose) and apply gentle pressure. This will||
2088|039|H|prevent the medication from draining out. Try not to blink and do||
2088|040|H|not rub your eye. Repeat these steps for your other eye if so||
2088|041|H|directed, and if your dose is for more than 1 drop. The dosage is||
2088|042|H|based on your medical condition and response to treatment.||
2088|043|H|   Do not rinse the dropper. Replace the dropper cap after each||
2088|044|H|use.||
2088|045|H|   If you are using another kind of eye medication (such as drops||
2088|046|H|or ointments), wait at least 5 to 10 minutes before applying||
2088|047|H|other medications. Use eye drops before eye ointments to allow||
2088|048|H|the eye drops to enter the eye.||
2088|049|H|   Wait several minutes for your vision to clear before driving||
2088|050|H|or operating machinery.||
2088|051|H|   Use this medication regularly in order to get the most benefit||
2088|052|H|from it. To help you remember, use it at the same times each day.||
2088|053|H|Continue to use this medication for the full time prescribed,||
2088|054|H|even if symptoms disappear after a few days. Stopping the||
2088|055|H|medication too early may result in a return of the infection.||
2088|056|H|   Tell your doctor if your condition lasts or gets worse.||
2088|057|B|||
2088|058|S|SIDE EFFECTS:  Temporary blurred vision, eye redness, eye||
2088|059|S|discomfort, and eyelid itching/swelling may occur. If any of||
2088|060|S|these effects last or get worse, tell your doctor or pharmacist||
2088|061|S|promptly.||
2088|062|S|   Remember that this medication has been prescribed because your||
2088|063|S|doctor has judged that the benefit to you is greater than the||
2088|064|S|risk of side effects. Many people using this medication do not||
2088|065|S|have serious side effects.||
2088|066|S|   Use of this medication for prolonged/repeated periods may||
2088|067|S|result in a new fungal eye infection and may increase your risk||
2088|068|S|for other eye problems (such as glaucoma, cataracts). Do not use||
2088|069|S|this medication for longer than prescribed. Tell your doctor||
2088|070|S|right away if you notice any of the following: new or worsening||
2088|071|S|eye symptoms (such as discharge, swelling), vision changes, eye||
2088|072|S|pain.||
2088|073|S|   A very serious allergic reaction to this drug is rare.||
2088|074|S|However, get medical help right away if you notice any symptoms||
2088|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2088|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2088|077|S|breathing.||
2088|078|S|   This is not a complete list of possible side effects. If you||
2088|079|S|notice other effects not listed above, contact your doctor or||
2088|080|S|pharmacist.||
2088|081|S|   In the US -||
2088|082|S|   Call your doctor for medical advice about side effects. You||
2088|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2088|084|S|www.fda.gov/medwatch.||
2088|085|S|   In Canada - Call your doctor for medical advice about side||
2088|086|S|effects. You may report side effects to Health Canada at||
2088|087|S|1-866-234-2345.||
2088|088|B|||
2088|089|P|PRECAUTIONS:  Before using tobramycin with dexamethasone, tell||
2088|090|P|your doctor or pharmacist if you are allergic to either drug; or||
2088|091|P|to other aminoglycoside antibiotics (such as gentamicin); or if||
2088|092|P|you have any other allergies. This product may contain inactive||
2088|093|P|ingredients (such as preservatives like benzalkonium chloride),||
2088|094|P|which can cause allergic reactions or other problems. Talk to||
2088|095|P|your pharmacist for more details.||
2088|096|P|   Before using this medication, tell your doctor or pharmacist||
2088|097|P|your medical history, especially of: other eye problems (such as||
2088|098|P|glaucoma).||
2088|099|P|   After you apply this drug, your vision may become temporarily||
2088|100|P|blurred or unstable. Do not drive, use machinery, or do anything||
2088|101|P|that needs clear vision until you can do it safely.||
2088|102|P|   During pregnancy, this medication should be used only when||
2088|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
2088|104|P|   It is unknown if this medication passes into breast milk.||
2088|105|P|Consult your doctor before breastfeeding.||
2088|106|B|||
2088|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2088|108|I|medications work or increase your risk for serious side effects.||
2088|109|I|This document does not contain all possible drug interactions.||
2088|110|I|Keep a list of all the products you use (including||
2088|111|I|prescription/nonprescription drugs and herbal products) and share||
2088|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2088|113|I|the dosage of any medicines without your doctor's approval.||
2088|114|B|||
2088|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2088|116|O|has overdosed and has serious symptoms such as passing out or||
2088|117|O|trouble breathing, call 911. Otherwise, call a poison control||
2088|118|O|center right away. US residents can call 1-800-222-1222. Canada||
2088|119|O|residents can call 1-844-764-7669.||
2088|120|B|||
2088|121|N|NOTES:  Do not share this medication with others.||
2088|122|N|   This medication has been prescribed for your current condition||
2088|123|N|only. Throw away the unused medication after treatment is||
2088|124|N|completed. Do not use it later for another infection unless your||
2088|125|N|doctor tells you to.||
2088|126|N|   If you are using this medication for more than 10 days, lab||
2088|127|N|and/or medical tests (such as eye exams) should be done while you||
2088|128|N|are using this medication. Keep all medical and lab appointments.||
2088|129|N|Consult your doctor for more details.||
2088|130|B|||
2088|131|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2088|132|D|If it is near the time of the next dose, skip the missed dose.||
2088|133|D|Use your next dose at the regular time. Do not double the dose to||
2088|134|D|catch up.||
2088|135|B|||
2088|136|R|STORAGE:  Store the bottle upright at room temperature away from||
2088|137|R|light. Some brands may also be stored in the refrigerator. Check||
2088|138|R|the product package for instructions on how to store your||
2088|139|R|product, or ask your pharmacist. Keep all medications away from||
2088|140|R|children and pets.||
2088|141|R|   Do not flush medications down the toilet or pour them into a||
2088|142|R|drain unless instructed to do so. Properly discard this product||
2088|143|R|when it is expired or no longer needed. Consult your pharmacist||
2088|144|R|or local waste disposal company.||
2088|145|B|||
2088|146|A|Information last revised September 2024.||
2088|147|A|Copyright(c) 2025 First Databank, Inc.||
2088|148|B|||
2089|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2089|002|Z|does NOT have all possible information about this product. This||
2089|003|Z|information does not assure that this product is safe, effective,||
2089|004|Z|or appropriate for you. This information is not individual||
2089|005|Z|medical advice and does not substitute for the advice of your||
2089|006|Z|health care professional. Always ask your health care||
2089|007|Z|professional for complete information about this product and your||
2089|008|Z|specific health needs.||
2089|009|B|||
2089|010|T|SODIUM CHLORIDE SOLUTION - INHALATION||
2089|011|F|(SOE-dee-um KLOR-ide)||
2089|012|B|||
2089|013|C|COMMON BRAND NAME(S): Hyper-Sal, Nebusal, Pulmosal||
2089|014|B|||
2089|015|U|USES:  This medication is used to help you cough up mucus||
2089|016|U|(sputum) in your lungs. It may also be used to mix with other||
2089|017|U|medications inhaled using a special machine called a nebulizer.||
2089|018|B|||
2089|019|H|HOW TO USE:  This medication is used with a special machine||
2089|020|H|called a nebulizer that changes the solution to a fine mist that||
2089|021|H|you inhale. Learn how to prepare the solution and use the||
2089|022|H|nebulizer properly. If a child is using this medication, a parent||
2089|023|H|or other responsible adult may need to help the child use the||
2089|024|H|nebulizer properly. If you have any questions, ask your doctor,||
2089|025|H|pharmacist, or respiratory therapist.||
2089|026|H|   This product should be clear and colorless. Before using,||
2089|027|H|check this product for particles or discoloration. If either is||
2089|028|H|present, do not use the liquid.||
2089|029|H|   Using the nebulizer, inhale this medication into your lungs as||
2089|030|H|directed by your doctor. Use this medication only through a||
2089|031|H|nebulizer. Do not swallow or inject the solution. Discard any||
2089|032|H|unused solution. Do not save for future use. To prevent||
2089|033|H|infections, clean the nebulizer and mouthpiece/face mask||
2089|034|H|according to the manufacturer's directions.||
2089|035|B|||
2089|036|S|SIDE EFFECTS:  This drug usually has no side effects. If you have||
2089|037|S|any unusual effects, contact your doctor or pharmacist promptly.||
2089|038|S|   Remember that this medication has been prescribed because your||
2089|039|S|doctor has judged that the benefit to you is greater than the||
2089|040|S|risk of side effects. Many people using this medication do not||
2089|041|S|have serious side effects.||
2089|042|S|   A very serious allergic reaction to this drug is rare.||
2089|043|S|However, get medical help right away if you notice any symptoms||
2089|044|S|of a serious allergic reaction, including: rash, itching/swelling||
2089|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2089|046|S|breathing.||
2089|047|S|   This is not a complete list of possible side effects. If you||
2089|048|S|notice other effects not listed above, contact your doctor or||
2089|049|S|pharmacist.||
2089|050|S|   In the US -||
2089|051|S|   Call your doctor for medical advice about side effects. You||
2089|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2089|053|S|www.fda.gov/medwatch.||
2089|054|S|   In Canada - Call your doctor for medical advice about side||
2089|055|S|effects. You may report side effects to Health Canada at||
2089|056|S|1-866-234-2345.||
2089|057|B|||
2089|058|P|PRECAUTIONS:  Before using sodium chloride solution, tell your||
2089|059|P|doctor or pharmacist if you are allergic to it; or if you have||
2089|060|P|any other allergies. This product may contain inactive||
2089|061|P|ingredients, which can cause allergic reactions or other||
2089|062|P|problems. Talk to your pharmacist for more details.||
2089|063|P|   Before using this medication, tell your doctor or pharmacist||
2089|064|P|your medical history.||
2089|065|P|   Before having surgery, tell your doctor or dentist about all||
2089|066|P|the products you use (including prescription drugs,||
2089|067|P|nonprescription drugs, and herbal products).||
2089|068|P|   This solution is safe to use during pregnancy or while||
2089|069|P|breastfeeding when used as directed.||
2089|070|B|||
2089|071|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2089|072|I|medications work or increase your risk for serious side effects.||
2089|073|I|This document does not contain all possible drug interactions.||
2089|074|I|Keep a list of all the products you use (including||
2089|075|I|prescription/nonprescription drugs and herbal products) and share||
2089|076|I|it with your doctor and pharmacist. Do not start, stop, or change||
2089|077|I|the dosage of any medicines without your doctor's approval.||
2089|078|B|||
2089|079|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2089|080|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2089|081|O|poison control center right away. US residents can call||
2089|082|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2089|083|B|||
2089|084|N|NOTES:  Do not share this medication with others.||
2089|085|B|||
2089|086|D|MISSED DOSE:  If you are using this medication on a regular||
2089|087|D|schedule and miss a dose, use it as soon as you remember. If it||
2089|088|D|is near the time of the next dose, skip the missed dose. Use your||
2089|089|D|next dose at the regular time. Do not double the dose to catch||
2089|090|D|up.||
2089|091|B|||
2089|092|R|STORAGE:  Store at room temperature away from heat. Do not||
2089|093|R|freeze. Keep all medications away from children and pets.||
2089|094|R|   Do not flush medications down the toilet or pour them into a||
2089|095|R|drain unless instructed to do so. Properly discard this product||
2089|096|R|when it is expired or no longer needed. Consult your pharmacist||
2089|097|R|or local waste disposal company.||
2089|098|B|||
2089|099|A|Information last revised January 2025.||
2089|100|A|Copyright(c) 2025 First Databank, Inc.||
2089|101|B|||
2090|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2090|002|Z|does NOT have all possible information about this product. This||
2090|003|Z|information does not assure that this product is safe, effective,||
2090|004|Z|or appropriate for you. This information is not individual||
2090|005|Z|medical advice and does not substitute for the advice of your||
2090|006|Z|health care professional. Always ask your health care||
2090|007|Z|professional for complete information about this product and your||
2090|008|Z|specific health needs.||
2090|009|B|||
2090|010|T|FEDRATINIB - ORAL||
2090|011|F|(fed-RA-ti-nib)||
2090|012|B|||
2090|013|C|COMMON BRAND NAME(S): Inrebic||
2090|014|B|||
2090|015|W|WARNING:  Rarely, a serious (sometimes fatal) brain condition||
2090|016|W|(encephalopathy) has occurred in people receiving this||
2090|017|W|medication. Low levels of vitamin B1 (thiamine) can increase your||
2090|018|W|risk. Your doctor will check your thiamine blood levels before||
2090|019|W|starting this medication and regularly during treatment. Your||
2090|020|W|doctor should direct you to take vitamin B1 (thiamine) while||
2090|021|W|using this medication. Get medical help right away if you develop||
2090|022|W|symptoms of encephalopathy such as mental/mood changes (including||
2090|023|W|confusion, trouble thinking clearly, memory loss),||
2090|024|W|balance/walking problems, or eye problems (such as double/blurred||
2090|025|W|vision or unusual eye movements).||
2090|026|B|||
2090|027|U|USES:  This medication is used to treat a certain type of cancer||
2090|028|U|(myelofibrosis). Fedratinib belongs to a class of drugs known as||
2090|029|U|kinase inhibitors. It works by slowing or stopping the growth of||
2090|030|U|cancer cells.||
2090|031|B|||
2090|032|H|HOW TO USE:  Read the Medication Guide provided by your||
2090|033|H|pharmacist before you start taking fedratinib and each time you||
2090|034|H|get a refill. If you have any questions, ask your doctor or||
2090|035|H|pharmacist.||
2090|036|H|   Take this medication by mouth with or without food as directed||
2090|037|H|by your doctor, usually once daily. If you have nausea or||
2090|038|H|vomiting, it may help to take this medication with a high-fat||
2090|039|H|meal.||
2090|040|H|   If you are unable to swallow the capsules, the capsules may be||
2090|041|H|opened and the contents poured into a glass container. Mix with 6||
2090|042|H|ounces (180 milliliters) of room temperature liquid nutritional||
2090|043|H|supplement and take the mixture within 2 hours. Throw away any||
2090|044|H|unused mixed medication after 2 hours. Ask your pharmacist which||
2090|045|H|brand of liquid nutritional supplement may be used to mix with||
2090|046|H|this medication.||
2090|047|H|   If you are giving this medication through a feeding tube, ask||
2090|048|H|your health care professional for detailed instructions on how to||
2090|049|H|properly mix and give it.||
2090|050|H|   The dosage is based on your medical condition, response to||
2090|051|H|treatment, and other medications you may be taking. Be sure to||
2090|052|H|tell your doctor and pharmacist about all the products you use||
2090|053|H|(including prescription drugs, nonprescription drugs, and herbal||
2090|054|H|products).||
2090|055|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2090|056|H|using this medication unless your doctor or pharmacist says you||
2090|057|H|may do so safely. Grapefruit can increase the chance of side||
2090|058|H|effects with this medicine. Ask your doctor or pharmacist for||
2090|059|H|more details.||
2090|060|H|   Take this medication regularly to get the most benefit from||
2090|061|H|it. To help you remember, take it at the same time each day.||
2090|062|H|   Do not increase your dose or use this drug more often or for||
2090|063|H|longer than prescribed. Your condition will not improve any||
2090|064|H|faster, and your risk of serious side effects will increase.||
2090|065|H|   Since this drug can be absorbed through the skin and lungs and||
2090|066|H|may harm an unborn baby, women who are pregnant or who may become||
2090|067|H|pregnant should not handle this medication or breathe the dust||
2090|068|H|from the capsules.||
2090|069|B|||
2090|070|S|SIDE EFFECTS:  See also Warning section.||
2090|071|S|   Diarrhea, nausea, and vomiting commonly occur and can be||
2090|072|S|severe. Your doctor may prescribe medication(s) to prevent or||
2090|073|S|help relieve diarrhea, nausea, and vomiting. Muscle spasms,||
2090|074|S|headache, dizziness, or unusual tiredness may also occur. If any||
2090|075|S|of these effects last or get worse, tell your doctor or||
2090|076|S|pharmacist promptly.||
2090|077|S|   People using this medication may have serious side effects.||
2090|078|S|However, you have been prescribed this drug because your doctor||
2090|079|S|has judged that the benefit to you is greater than the risk of||
2090|080|S|side effects. Careful monitoring by your doctor may decrease your||
2090|081|S|risk.||
2090|082|S|   Tell your doctor right away if you have any serious side||
2090|083|S|effects, including: easy bruising/bleeding, signs of heart||
2090|084|S|failure (such as shortness of breath, swelling ankles/feet,||
2090|085|S|unusual/sudden weight gain), signs of liver problems (such as||
2090|086|S|nausea/vomiting that doesn't stop, loss of appetite,||
2090|087|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), eye||
2090|088|S|pain/swelling/redness, vision changes (such new/increased||
2090|089|S|floaters, sensitivity to light).||
2090|090|S|   This medication may lower your ability to fight infections.||
2090|091|S|This may make you more likely to get a serious (rarely fatal)||
2090|092|S|infection or make any infection you have worse. Tell your doctor||
2090|093|S|right away if you have any signs of infection (such as sore||
2090|094|S|throat that doesn't go away, fever, chills).||
2090|095|S|   Another medication similar to fedratinib has caused serious||
2090|096|S|(possibly fatal) side effects, including heart problems, blood||
2090|097|S|clots, and cancer (such as lymphoma). Before using fedratinib,||
2090|098|S|tell your doctor or pharmacist if you have a history of heart||
2090|099|S|disease, stroke, other cancers, or any risk factors for heart||
2090|100|S|disease (such as high blood pressure, diabetes, previous blood||
2090|101|S|clots, high cholesterol, smoking or history of smoking). Discuss||
2090|102|S|the risks and benefits of treatment with your doctor. Get medical||
2090|103|S|help right away if you have symptoms such as: shortness of||
2090|104|S|breath/rapid breathing, chest/jaw/left arm pain, confusion,||
2090|105|S|unusual sweating, sudden dizziness/fainting, pain/swelling/warmth||
2090|106|S|in the groin/calf, sudden/severe headaches, trouble speaking,||
2090|107|S|weakness on one side of the body, sudden vision changes.||
2090|108|S|   A very serious allergic reaction to this drug is rare.||
2090|109|S|However, get medical help right away if you notice any symptoms||
2090|110|S|of a serious allergic reaction, including: rash, itching/swelling||
2090|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2090|112|S|breathing.||
2090|113|S|   This is not a complete list of possible side effects. If you||
2090|114|S|notice other effects not listed above, contact your doctor or||
2090|115|S|pharmacist.||
2090|116|S|   In the US -||
2090|117|S|   Call your doctor for medical advice about side effects. You||
2090|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2090|119|S|www.fda.gov/medwatch.||
2090|120|S|   In Canada - Call your doctor for medical advice about side||
2090|121|S|effects. You may report side effects to Health Canada at||
2090|122|S|1-866-234-2345.||
2090|123|B|||
2090|124|P|PRECAUTIONS:  See also Side Effects section.||
2090|125|P|   Before taking fedratinib, tell your doctor or pharmacist if||
2090|126|P|you are allergic to it; or if you have any other allergies. This||
2090|127|P|product may contain inactive ingredients, which can cause||
2090|128|P|allergic reactions or other problems. Talk to your pharmacist for||
2090|129|P|more details.||
2090|130|P|   Before using this medication, tell your doctor or pharmacist||
2090|131|P|your medical history, especially of: low vitamin B1 (thiamine)||
2090|132|P|levels, bleeding/blood problems, kidney problems, liver problems,||
2090|133|P|pancreatitis.||
2090|134|P|   Fedratinib can make you more likely to get infections or may||
2090|135|P|make current infections worse. Stay away from anyone who has an||
2090|136|P|infection that may easily spread (such as chickenpox, COVID-19,||
2090|137|P|measles, flu). Talk to your doctor if you have been exposed to an||
2090|138|P|infection or for more details.||
2090|139|P|   Tell your health care professional that you are using||
2090|140|P|fedratinib before having any immunizations/vaccinations. Avoid||
2090|141|P|contact with people who have recently received live vaccines||
2090|142|P|(such as flu vaccine inhaled through the nose).||
2090|143|P|   To lower the chance of getting cut, bruised, or injured, use||
2090|144|P|caution with sharp objects like razors and nail cutters, and||
2090|145|P|avoid activities such as contact sports.||
2090|146|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2090|147|P|can make you more dizzy. Do not drive, use machinery, or do||
2090|148|P|anything that needs alertness until you can do it safely. Limit||
2090|149|P|alcoholic beverages. Talk to your doctor if you are using||
2090|150|P|marijuana (cannabis).||
2090|151|P|   Before having surgery, tell your doctor or dentist about all||
2090|152|P|the products you use (including prescription drugs,||
2090|153|P|nonprescription drugs, and herbal products).||
2090|154|P|   Since this drug can be absorbed through the skin and lungs and||
2090|155|P|may harm an unborn baby, women who are pregnant or who may become||
2090|156|P|pregnant should not handle this medication or breathe the dust||
2090|157|P|from the capsules.||
2090|158|P|   Tell your doctor if you are pregnant or plan to become||
2090|159|P|pregnant. You should not become pregnant while using fedratinib.||
2090|160|P|Fedratinib may harm an unborn baby. If you become pregnant, talk||
2090|161|P|to your doctor right away about the risks and benefits of this||
2090|162|P|medication.||
2090|163|P|   It is unknown if this drug passes into breast milk. Because of||
2090|164|P|the possible risk to the infant, breastfeeding is not recommended||
2090|165|P|while using this drug and for at least 1 month after the last||
2090|166|P|dose. Consult your doctor before breastfeeding.||
2090|167|B|||
2090|168|I|DRUG INTERACTIONS:  See also How to Use section.||
2090|169|I|   Drug interactions may change how your medications work or||
2090|170|I|increase your risk for serious side effects. This document does||
2090|171|I|not contain all possible drug interactions. Keep a list of all||
2090|172|I|the products you use (including prescription/nonprescription||
2090|173|I|drugs and herbal products) and share it with your doctor and||
2090|174|I|pharmacist. Do not start, stop, or change the dosage of any||
2090|175|I|medicines without your doctor's approval.||
2090|176|I|   Other medications can affect the removal of fedratinib from||
2090|177|I|your body, which may affect how fedratinib works. Examples||
2090|178|I|include ketoconazole, rifamycins (such as rifabutin, rifampin),||
2090|179|I|St. John's wort, drugs used to treat seizures (such as||
2090|180|I|carbamazepine, phenobarbital, phenytoin), among others.||
2090|181|I|   This medication can slow down the removal of other medications||
2090|182|I|from your body, which may affect how they work. Examples include||
2090|183|I|elacestrant, flibanserin, lomitapide, mavacamten, among others.||
2090|184|B|||
2090|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2090|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2090|187|O|poison control center right away. US residents can call||
2090|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2090|189|B|||
2090|190|N|NOTES:  Do not share this medication with others.||
2090|191|N|   Lab and/or medical tests (such as thiamine blood levels,||
2090|192|N|complete blood count, kidney/liver function, amylase/lipase)||
2090|193|N|should be done before you start taking this medication and while||
2090|194|N|you are taking it. Keep all medical and lab appointments.||
2090|195|B|||
2090|196|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2090|197|D|next dose at the regular time. Do not double the dose to catch||
2090|198|D|up.||
2090|199|B|||
2090|200|R|STORAGE:  Store at room temperature away from light and moisture.||
2090|201|R|Do not store in the bathroom. Keep all medications away from||
2090|202|R|children and pets.||
2090|203|R|   Do not flush medications down the toilet or pour them into a||
2090|204|R|drain unless instructed to do so. Properly discard this product||
2090|205|R|when it is expired or no longer needed. Consult your pharmacist||
2090|206|R|or local waste disposal company.||
2090|207|B|||
2090|208|M|MEDICAL ALERT:  Your condition can cause complications in a||
2090|209|M|medical emergency. For information about enrolling in MedicAlert,||
2090|210|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2090|211|B|||
2090|212|A|Information last revised May 2025.||
2090|213|A|Copyright(c) 2025 First Databank, Inc.||
2090|214|B|||
2091|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2091|002|Z|does NOT have all possible information about this product. This||
2091|003|Z|information does not assure that this product is safe, effective,||
2091|004|Z|or appropriate for you. This information is not individual||
2091|005|Z|medical advice and does not substitute for the advice of your||
2091|006|Z|health care professional. Always ask your health care||
2091|007|Z|professional for complete information about this product and your||
2091|008|Z|specific health needs.||
2091|009|B|||
2091|010|T|LEFAMULIN - ORAL||
2091|011|F|(le-FAM-ue-lin)||
2091|012|B|||
2091|013|C|COMMON BRAND NAME(S): Xenleta||
2091|014|B|||
2091|015|U|USES:  This medication is used to treat a wide variety of||
2091|016|U|bacterial infections. It works by stopping the growth of||
2091|017|U|bacteria.||
2091|018|U|   This antibiotic treats only bacterial infections. It will not||
2091|019|U|work for viral infections (such as common cold, flu). Using any||
2091|020|U|antibiotic when it is not needed can cause it to not work for||
2091|021|U|future infections.||
2091|022|B|||
2091|023|H|HOW TO USE:  Take this medication by mouth on an empty stomach||
2091|024|H|(at least 1 hour before or 2 hours after a meal) with a glass of||
2091|025|H|water (6 to 8 ounces/180 to 240 milliliters) as directed by your||
2091|026|H|doctor, usually twice daily (12 hours apart). The manufacturer||
2091|027|H|directs not to split or crush the tablet before taking it.||
2091|028|H|However, many similar drugs (immediate-release tablets) can be||
2091|029|H|split or crushed. Follow your doctor's directions on how to take||
2091|030|H|this medication. The dosage is based on your medical condition||
2091|031|H|and response to treatment.||
2091|032|H|   For the best effect, take this antibiotic at evenly spaced||
2091|033|H|times. To help you remember, take this medication at the same||
2091|034|H|times every day.||
2091|035|H|   Continue to take this medication until the full prescribed||
2091|036|H|amount is finished, even if symptoms disappear after a few days.||
2091|037|H|Stopping the medication too early may result in a return of the||
2091|038|H|infection.||
2091|039|H|   Tell your doctor if your condition lasts or gets worse.||
2091|040|B|||
2091|041|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. If any of||
2091|042|S|these effects last or get worse, tell your doctor or pharmacist||
2091|043|S|promptly.||
2091|044|S|   Remember that this medication has been prescribed because your||
2091|045|S|doctor has judged that the benefit to you is greater than the||
2091|046|S|risk of side effects. Many people using this medication do not||
2091|047|S|have serious side effects.||
2091|048|S|   Get medical help right away if you have any very serious side||
2091|049|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2091|050|S|fainting.||
2091|051|S|   This medication may rarely cause a severe intestinal condition||
2091|052|S|due to a bacteria called C. difficile. This condition may occur||
2091|053|S|during treatment or weeks to months after treatment has stopped.||
2091|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2091|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2091|056|S|stool.||
2091|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2091|058|S|products because they may make symptoms worse.||
2091|059|S|   Use of this medication for prolonged or repeated periods may||
2091|060|S|result in oral thrush or a new yeast infection. Contact your||
2091|061|S|doctor if you notice white patches in your mouth, a change in||
2091|062|S|vaginal discharge, or other new symptoms.||
2091|063|S|   A very serious allergic reaction to this drug is rare.||
2091|064|S|However, get medical help right away if you notice any symptoms||
2091|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2091|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2091|067|S|breathing.||
2091|068|S|   This is not a complete list of possible side effects. If you||
2091|069|S|notice other effects not listed above, contact your doctor or||
2091|070|S|pharmacist.||
2091|071|S|   In the US -||
2091|072|S|   Call your doctor for medical advice about side effects. You||
2091|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2091|074|S|www.fda.gov/medwatch.||
2091|075|S|   In Canada - Call your doctor for medical advice about side||
2091|076|S|effects. You may report side effects to Health Canada at||
2091|077|S|1-866-234-2345.||
2091|078|B|||
2091|079|P|PRECAUTIONS:  Before taking lefamulin, tell your doctor or||
2091|080|P|pharmacist if you are allergic to it; or if you have any other||
2091|081|P|allergies. This product may contain inactive ingredients, which||
2091|082|P|can cause allergic reactions or other problems. Talk to your||
2091|083|P|pharmacist for more details.||
2091|084|P|   Before using this medication, tell your doctor or pharmacist||
2091|085|P|your medical history, especially of: liver problems.||
2091|086|P|   Lefamulin may cause a condition that affects the heart rhythm||
2091|087|P|(QT prolongation). QT prolongation can rarely cause serious||
2091|088|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2091|089|P|as severe dizziness, fainting) that need medical attention right||
2091|090|P|away.||
2091|091|P|   The risk of QT prolongation may be increased if you have||
2091|092|P|certain medical conditions or are taking other drugs that may||
2091|093|P|cause QT prolongation. Before using lefamulin, tell your doctor||
2091|094|P|or pharmacist of all the drugs you take and if you have any of||
2091|095|P|the following conditions: certain heart problems (heart failure,||
2091|096|P|slow heartbeat, QT prolongation in the EKG), family history of||
2091|097|P|certain heart problems (QT prolongation in the EKG, sudden||
2091|098|P|cardiac death).||
2091|099|P|   Low levels of potassium or magnesium in the blood may also||
2091|100|P|increase your risk of QT prolongation. This risk may increase if||
2091|101|P|you use certain drugs (such as diuretics/"water pills") or if you||
2091|102|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2091|103|P|Talk to your doctor about using lefamulin safely.||
2091|104|P|   Lefamulin may cause live bacterial vaccines (such as typhoid||
2091|105|P|vaccine) to not work well. Tell your health care professional||
2091|106|P|that you are using lefamulin before having any||
2091|107|P|immunizations/vaccinations.||
2091|108|P|   Before having surgery, tell your doctor or dentist about all||
2091|109|P|the products you use (including prescription drugs,||
2091|110|P|nonprescription drugs, and herbal products).||
2091|111|P|   Older adults may be more sensitive to the side effects of this||
2091|112|P|drug, especially QT prolongation (see above).||
2091|113|P|   Tell your doctor if you are pregnant or plan to become||
2091|114|P|pregnant. You should not become pregnant while using lefamulin.||
2091|115|P|Lefamulin may harm an unborn baby. Your doctor should order a||
2091|116|P|pregnancy test before you start this medication. Ask about||
2091|117|P|reliable forms of birth control while using this medication and||
2091|118|P|for 2 days after the last dose. If you become pregnant, talk to||
2091|119|P|your doctor right away about the risks and benefits of this||
2091|120|P|medication.||
2091|121|P|   It is unknown if this drug passes into breast milk. Because of||
2091|122|P|the possible risk to the infant, breastfeeding is not recommended||
2091|123|P|while using this drug and for 2 days after the last dose. Consult||
2091|124|P|your doctor before breastfeeding.||
2091|125|B|||
2091|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2091|127|I|medications work or increase your risk for serious side effects.||
2091|128|I|This document does not contain all possible drug interactions.||
2091|129|I|Keep a list of all the products you use (including||
2091|130|I|prescription/nonprescription drugs and herbal products) and share||
2091|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
2091|132|I|the dosage of any medicines without your doctor's approval.||
2091|133|I|   Other medications can affect the removal of lefamulin from||
2091|134|I|your body, which may affect how lefamulin works. Examples include||
2091|135|I|azole antifungals (such as fluconazole, itraconazole), HIV||
2091|136|I|protease inhibitors (such as nelfinavir), rifamycins (such as||
2091|137|I|rifabutin, rifampin), ritonavir, St. John's wort, drugs used to||
2091|138|I|treat seizures (such as carbamazepine, phenytoin), among others.||
2091|139|I|   Many drugs besides lefamulin may affect the heart rhythm (QT||
2091|140|I|prolongation), including artemether/lumefantrine, dasatinib,||
2091|141|I|dronedarone, eliglustat, entrectinib, midostaurin, mobocertinib,||
2091|142|I|pimozide, quetiapine, tacrolimus, among others.||
2091|143|I|   This medication can slow down the removal of other medications||
2091|144|I|from your body, which may affect how they work. Examples include||
2091|145|I|elacestrant, lomitapide, lonafarnib, among others.||
2091|146|B|||
2091|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2091|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2091|149|O|poison control center right away. US residents can call||
2091|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2091|151|B|||
2091|152|N|NOTES:  Do not share this medication with others.||
2091|153|N|   This medication has been prescribed for your current condition||
2091|154|N|only. Do not use it later for another infection unless your||
2091|155|N|doctor tells you to.||
2091|156|B|||
2091|157|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2091|158|D|remember. If it is less than 8 hours before the next dose, skip||
2091|159|D|the missed dose. Take your next dose at the regular time. Do not||
2091|160|D|double the dose to catch up.||
2091|161|B|||
2091|162|R|STORAGE:  Store at room temperature away from light and moisture.||
2091|163|R|Do not store in the bathroom. Keep all medications away from||
2091|164|R|children and pets.||
2091|165|R|   Do not flush medications down the toilet or pour them into a||
2091|166|R|drain unless instructed to do so. Properly discard this product||
2091|167|R|when it is expired or no longer needed. Consult your pharmacist||
2091|168|R|or local waste disposal company.||
2091|169|B|||
2091|170|A|Information last revised April 2025.||
2091|171|A|Copyright(c) 2025 First Databank, Inc.||
2091|172|B|||
2093|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2093|002|Z|does NOT have all possible information about this product. This||
2093|003|Z|information does not assure that this product is safe, effective,||
2093|004|Z|or appropriate for you. This information is not individual||
2093|005|Z|medical advice and does not substitute for the advice of your||
2093|006|Z|health care professional. Always ask your health care||
2093|007|Z|professional for complete information about this product and your||
2093|008|Z|specific health needs.||
2093|009|B|||
2093|010|T|OFLOXACIN - ORAL||
2093|011|F|(oh-FLOX-uh-sin)||
2093|012|B|||
2093|013|C|COMMON BRAND NAME(S): Floxin||
2093|014|B|||
2093|015|W|WARNING:  Quinolone antibiotics (including ofloxacin) may cause||
2093|016|W|serious and possibly permanent tendon damage (such as tendonitis,||
2093|017|W|tendon rupture), nerve problems in the arms and legs (peripheral||
2093|018|W|neuropathy), and nervous system problems. Get medical help right||
2093|019|W|away if you have any of the following symptoms:||
2093|020|W|pain/numbness/burning/tingling/weakness in your||
2093|021|W|arms/hands/legs/feet, changes in how you sense||
2093|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
2093|023|W|headache, vision changes, shaking (tremors), seizures,||
2093|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
2093|025|W|hallucinations, depression, rare thoughts of suicide).||
2093|026|W|   Tendon damage may occur during or after treatment with this||
2093|027|W|medication. Stop exercising, rest, and get medical help right||
2093|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
2093|029|W|risk for tendon problems is greater if you are over 60 years of||
2093|030|W|age, if you are taking corticosteroids (such as prednisone), or||
2093|031|W|if you have a kidney, heart, or lung transplant.||
2093|032|W|   This medication may make a certain muscle condition||
2093|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
2093|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
2093|035|W|unsteady walk) or trouble breathing.||
2093|036|W|   Discuss the risks and benefits with your doctor before using||
2093|037|W|this medication.||
2093|038|B|||
2093|039|U|USES:  This medication is used to treat a variety of bacterial||
2093|040|U|infections. Ofloxacin belongs to a class of drugs called||
2093|041|U|quinolone antibiotics. It works by stopping the growth of||
2093|042|U|bacteria.||
2093|043|U|   This antibiotic treats only bacterial infections. It will not||
2093|044|U|work for viral infections (such as common cold, flu). Using any||
2093|045|U|antibiotic when it is not needed can cause it to not work for||
2093|046|U|future infections.||
2093|047|B|||
2093|048|H|HOW TO USE:  Read the Medication Guide provided by your||
2093|049|H|pharmacist before you start taking ofloxacin and each time you||
2093|050|H|get a refill. If you have any questions, ask your doctor or||
2093|051|H|pharmacist.||
2093|052|H|   Take this medication by mouth with or without food as directed||
2093|053|H|by your doctor, usually twice a day (every 12 hours). The dosage||
2093|054|H|and length of treatment is based on your medical condition and||
2093|055|H|response to treatment.||
2093|056|H|   Drink plenty of fluids while taking this medication unless||
2093|057|H|your doctor tells you otherwise.||
2093|058|H|   Take this medication at least 2 hours before or 2 hours after||
2093|059|H|taking other products that may bind to it, decreasing its||
2093|060|H|effectiveness. Ask your pharmacist about the other products you||
2093|061|H|take. Some examples include: quinapril, sucralfate,||
2093|062|H|vitamins/minerals (including iron and zinc supplements), and||
2093|063|H|products containing magnesium, aluminum, or calcium (such as||
2093|064|H|antacids, calcium supplements).||
2093|065|H|   For the best effect, take this antibiotic at evenly spaced||
2093|066|H|times. To help you remember, take this medication at the same||
2093|067|H|time(s) every day.||
2093|068|H|   Continue to take this medication until the full prescribed||
2093|069|H|amount is finished, even if symptoms disappear after a few days.||
2093|070|H|Stopping the medication too early may result in a return of the||
2093|071|H|infection.||
2093|072|H|   Tell your doctor if your condition lasts or gets worse.||
2093|073|B|||
2093|074|S|SIDE EFFECTS:  See also Warning section.||
2093|075|S|   Upset stomach, nausea, diarrhea, headache, dizziness,||
2093|076|S|lightheadedness, or trouble sleeping may occur. If any of these||
2093|077|S|effects last or get worse, tell your doctor or pharmacist||
2093|078|S|promptly.||
2093|079|S|   Remember that this medication has been prescribed because your||
2093|080|S|doctor has judged that the benefit to you is greater than the||
2093|081|S|risk of side effects. Many people using this medication do not||
2093|082|S|have serious side effects.||
2093|083|S|   Tell your doctor right away if you have any serious side||
2093|084|S|effects, including: easy bruising/bleeding, signs of a new||
2093|085|S|infection (such as sore throat that doesn't go away, fever),||
2093|086|S|signs of kidney problems (such as change in the amount of urine),||
2093|087|S|signs of liver problems (such as nausea/vomiting that doesn't||
2093|088|S|stop, unusual tiredness, stomach/abdominal pain, yellowing||
2093|089|S|eyes/skin, dark urine).||
2093|090|S|   Get medical help right away if you have any very serious side||
2093|091|S|effects, including: hearing changes, unsteadiness, severe||
2093|092|S|dizziness, fainting, fast/irregular heartbeat, signs of a||
2093|093|S|tear/break in the main blood vessel called the aorta (such as||
2093|094|S|sudden/severe pain in the stomach/chest/back, shortness of||
2093|095|S|breath).||
2093|096|S|   This medication may rarely cause a severe intestinal condition||
2093|097|S|due to a bacteria called C. difficile. This condition may occur||
2093|098|S|during treatment or weeks to months after treatment has stopped.||
2093|099|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2093|100|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2093|101|S|stool.||
2093|102|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2093|103|S|products because they may make symptoms worse.||
2093|104|S|   Use of this medication for prolonged or repeated periods may||
2093|105|S|result in oral thrush or a new yeast infection. Contact your||
2093|106|S|doctor if you notice white patches in your mouth, a change in||
2093|107|S|vaginal discharge, or other new symptoms.||
2093|108|S|   A very serious allergic reaction to this drug is rare.||
2093|109|S|However, get medical help right away if you notice any symptoms||
2093|110|S|of a serious allergic reaction, including: rash, itching/swelling||
2093|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2093|112|S|breathing.||
2093|113|S|   This is not a complete list of possible side effects. If you||
2093|114|S|notice other effects not listed above, contact your doctor or||
2093|115|S|pharmacist.||
2093|116|S|   In the US -||
2093|117|S|   Call your doctor for medical advice about side effects. You||
2093|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2093|119|S|www.fda.gov/medwatch.||
2093|120|S|   In Canada - Call your doctor for medical advice about side||
2093|121|S|effects. You may report side effects to Health Canada at||
2093|122|S|1-866-234-2345.||
2093|123|B|||
2093|124|P|PRECAUTIONS:  See also Warning section.||
2093|125|P|   Before taking ofloxacin, tell your doctor or pharmacist if you||
2093|126|P|are allergic to it; or to other quinolone antibiotics (such as||
2093|127|P|ciprofloxacin, levofloxacin); or if you have any other allergies.||
2093|128|P|This product may contain inactive ingredients, which can cause||
2093|129|P|allergic reactions or other problems. Talk to your pharmacist for||
2093|130|P|more details.||
2093|131|P|   Before using this medication, tell your doctor or pharmacist||
2093|132|P|your medical history, especially of: seizure disorder, conditions||
2093|133|P|that increase your risk of seizures (such as brain/head injury,||
2093|134|P|brain tumors), nerve problems (such as peripheral neuropathy),||
2093|135|P|kidney disease, liver disease, mental/mood disorders (such as||
2093|136|P|depression), myasthenia gravis, joint/tendon problems (such as||
2093|137|P|tendonitis, bursitis), blood vessel problems (such as aneurysm or||
2093|138|P|blockage of the aorta or other blood vessels, hardening of the||
2093|139|P|arteries), high blood pressure, certain genetic conditions||
2093|140|P|(Marfan syndrome, Ehlers-Danlos syndrome).||
2093|141|P|   Ofloxacin may cause a condition that affects the heart rhythm||
2093|142|P|(QT prolongation). QT prolongation can rarely cause serious||
2093|143|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2093|144|P|as severe dizziness, fainting) that need medical attention right||
2093|145|P|away.||
2093|146|P|   The risk of QT prolongation may be increased if you have||
2093|147|P|certain medical conditions or are taking other drugs that may||
2093|148|P|cause QT prolongation. Before using ofloxacin, tell your doctor||
2093|149|P|or pharmacist of all the drugs you take and if you have any of||
2093|150|P|the following conditions: certain heart problems (heart failure,||
2093|151|P|slow heartbeat, QT prolongation in the EKG), family history of||
2093|152|P|certain heart problems (QT prolongation in the EKG, sudden||
2093|153|P|cardiac death).||
2093|154|P|   Low levels of potassium or magnesium in the blood may also||
2093|155|P|increase your risk of QT prolongation. This risk may increase if||
2093|156|P|you use certain drugs (such as diuretics/"water pills") or if you||
2093|157|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2093|158|P|Talk to your doctor about using ofloxacin safely.||
2093|159|P|   This medication may rarely cause serious changes in blood||
2093|160|P|sugar, especially if you have diabetes. Check your blood sugar||
2093|161|P|regularly as directed and share the results with your doctor.||
2093|162|P|Watch for symptoms of high blood sugar, such as increased||
2093|163|P|thirst/urination. Also watch for symptoms of low blood sugar such||
2093|164|P|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
2093|165|P|vision, dizziness, or tingling hands/feet. It is a good habit to||
2093|166|P|carry glucose tablets or gel to treat low blood sugar. If you||
2093|167|P|don't have these reliable forms of glucose, rapidly raise your||
2093|168|P|blood sugar by eating a quick source of sugar such as table||
2093|169|P|sugar, honey, or candy, or by drinking fruit juice or non-diet||
2093|170|P|soda. Tell your doctor right away about the reaction and the use||
2093|171|P|of this product. To help prevent low blood sugar, eat meals on a||
2093|172|P|regular schedule, and do not skip meals. Your doctor may need to||
2093|173|P|switch you to another antibiotic or adjust your diabetes||
2093|174|P|medications if any reaction occurs.||
2093|175|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2093|176|P|can make you more dizzy. Do not drive, use machinery, or do||
2093|177|P|anything that needs alertness until you can do it safely. Limit||
2093|178|P|alcoholic beverages. Talk to your doctor if you are using||
2093|179|P|marijuana (cannabis).||
2093|180|P|   Ofloxacin may cause live bacterial vaccines (such as typhoid||
2093|181|P|vaccine) to not work well. Tell your health care professional||
2093|182|P|that you are using ofloxacin before having any||
2093|183|P|immunizations/vaccinations.||
2093|184|P|   This medication may make you more sensitive to the sun. Limit||
2093|185|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2093|186|P|sunscreen and wear protective clothing when outdoors. Tell your||
2093|187|P|doctor right away if you get sunburned or have skin||
2093|188|P|blisters/redness.||
2093|189|P|   Before having surgery, tell your doctor or dentist about all||
2093|190|P|the products you use (including prescription drugs,||
2093|191|P|nonprescription drugs, and herbal products).||
2093|192|P|   Children may be more sensitive to the side effects of this||
2093|193|P|drug, especially joint/tendon problems.||
2093|194|P|   Older adults may be at greater risk for tendon problems||
2093|195|P|(especially if they are also taking corticosteroids such as||
2093|196|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
2093|197|P|tear/break in the main blood vessel (aorta).||
2093|198|P|   During pregnancy, this medication should be used only when||
2093|199|P|clearly needed. Discuss the risks and benefits with your doctor.||
2093|200|P|   This medication passes into breast milk. Consult your doctor||
2093|201|P|before breastfeeding.||
2093|202|B|||
2093|203|I|DRUG INTERACTIONS:  See also Warning, How to Use, and Precautions||
2093|204|I|sections.||
2093|205|I|   Drug interactions may change how your medications work or||
2093|206|I|increase your risk for serious side effects. This document does||
2093|207|I|not contain all possible drug interactions. Keep a list of all||
2093|208|I|the products you use (including prescription/nonprescription||
2093|209|I|drugs and herbal products) and share it with your doctor and||
2093|210|I|pharmacist. Do not start, stop, or change the dosage of any||
2093|211|I|medicines without your doctor's approval.||
2093|212|I|   Some products that may interact with this drug include: "blood||
2093|213|I|thinners" (such as acenocoumarol, warfarin), strontium.||
2093|214|I|   Many drugs besides ofloxacin may affect the heart rhythm (QT||
2093|215|I|prolongation), including dofetilide, procainamide, amiodarone,||
2093|216|I|quinidine, sotalol, among others.||
2093|217|I|   Ofloxacin is very similar to levofloxacin. Do not use||
2093|218|I|medications containing levofloxacin while using ofloxacin.||
2093|219|I|   This medication may interfere with certain lab tests (such as||
2093|220|I|urine screening for opiates), possibly causing false test||
2093|221|I|results. Make sure lab personnel and all your doctors know you||
2093|222|I|use this drug.||
2093|223|B|||
2093|224|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2093|225|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2093|226|O|poison control center right away. US residents can call||
2093|227|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2093|228|O|Symptoms of overdose may include: severe dizziness.||
2093|229|B|||
2093|230|N|NOTES:  Do not share this medication with others.||
2093|231|N|   This medication has been prescribed for your current condition||
2093|232|N|only. Do not use it later for another infection unless your||
2093|233|N|doctor tells you to.||
2093|234|N|   Lab and/or medical tests may be done while you are taking this||
2093|235|N|medication. Keep all medical and lab appointments. Consult your||
2093|236|N|doctor for more details.||
2093|237|B|||
2093|238|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2093|239|D|remember. If it is near the time of the next dose, skip the||
2093|240|D|missed dose. Take your next dose at the regular time. Do not||
2093|241|D|double the dose to catch up.||
2093|242|B|||
2093|243|R|STORAGE:  Store at room temperature away from light and moisture.||
2093|244|R|Do not store in the bathroom. Keep all medications away from||
2093|245|R|children and pets.||
2093|246|R|   Do not flush medications down the toilet or pour them into a||
2093|247|R|drain unless instructed to do so. Properly discard this product||
2093|248|R|when it is expired or no longer needed. Consult your pharmacist||
2093|249|R|or local waste disposal company.||
2093|250|B|||
2093|251|A|Information last revised May 2024.||
2093|252|A|Copyright(c) 2025 First Databank, Inc.||
2093|253|B|||
2094|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2094|002|Z|does NOT have all possible information about this product. This||
2094|003|Z|information does not assure that this product is safe, effective,||
2094|004|Z|or appropriate for you. This information is not individual||
2094|005|Z|medical advice and does not substitute for the advice of your||
2094|006|Z|health care professional. Always ask your health care||
2094|007|Z|professional for complete information about this product and your||
2094|008|Z|specific health needs.||
2094|009|B|||
2094|010|T|DEXMETHYLPHENIDATE - ORAL||
2094|011|F|(dex-METH-il-FEN-i-date)||
2094|012|B|||
2094|013|C|COMMON BRAND NAME(S): Focalin||
2094|014|B|||
2094|015|W|WARNING:  Misuse or abuse of dexmethylphenidate may result in||
2094|016|W|serious (possibly fatal) heart and blood pressure problems.||
2094|017|W|   This medication can be habit-forming and should be used||
2094|018|W|cautiously by people who have mental/mood disorders or a||
2094|019|W|substance use disorder (such as overuse of or addiction to||
2094|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
2094|021|W|you have a personal or family history of a substance use||
2094|022|W|disorder. Do not increase your dose, use it more often, or use it||
2094|023|W|for a longer time or in a different way than prescribed. Doing so||
2094|024|W|may result in a decrease in the effect of this drug, drug||
2094|025|W|dependence, or abnormal thoughts/behavior.||
2094|026|W|   Your doctor may monitor you for a while after the medication||
2094|027|W|is stopped, especially if you have taken this drug for a long||
2094|028|W|time or in high doses. (See also How to Use section.)||
2094|029|B|||
2094|030|U|USES:  This medication is used to treat attention deficit||
2094|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
2094|032|U|of certain natural substances in the brain. Dexmethylphenidate||
2094|033|U|belongs to a class of drugs known as stimulants. It can help||
2094|034|U|increase your ability to pay attention, stay focused on an||
2094|035|U|activity, and control behavior problems. It may also help you to||
2094|036|U|organize your tasks and improve listening skills.||
2094|037|B|||
2094|038|V|OTHER USES:  This section contains uses of this drug that are not||
2094|039|V|listed in the approved professional labeling for the drug but||
2094|040|V|that may be prescribed by your health care professional. Use this||
2094|041|V|drug for a condition that is listed in this section only if it||
2094|042|V|has been so prescribed by your health care professional.||
2094|043|V|   This drug may also be used for a certain sleep disorder||
2094|044|V|(narcolepsy).||
2094|045|B|||
2094|046|H|HOW TO USE:  Read the Medication Guide provided by your||
2094|047|H|pharmacist before you start taking dexmethylphenidate and each||
2094|048|H|time you get a refill. If you have any questions, ask your doctor||
2094|049|H|or pharmacist.||
2094|050|H|   Take this medication by mouth as directed by your doctor,||
2094|051|H|usually twice a day with or without food. Take the first dose as||
2094|052|H|soon as you wake up in the morning and the second dose at least 4||
2094|053|H|hours later, or take as directed by your doctor. Taking this||
2094|054|H|medication late in the day may cause trouble sleeping (insomnia).||
2094|055|H|   The dosage is based on your medical condition and response to||
2094|056|H|treatment. Your doctor may direct you to gradually increase or||
2094|057|H|decrease your dose. Also, if you have used it for a long time, do||
2094|058|H|not suddenly stop using this drug without consulting your doctor.||
2094|059|H|The total daily dose is usually 20 milligrams or less. Carefully||
2094|060|H|follow your doctor's instructions.||
2094|061|H|   Methylphenidate and dexmethylphenidate are different||
2094|062|H|medications and do not provide the same amount of medicine. Do||
2094|063|H|not switch between products unless your doctor tells you to.||
2094|064|H|   Take this medication regularly to get the most benefit from||
2094|065|H|it. To help you remember, take it at the same times each day.||
2094|066|H|   If you suddenly stop using this medication, you may have||
2094|067|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
2094|068|H|other mental/mood changes). To help prevent withdrawal, your||
2094|069|H|doctor may lower your dose slowly. Withdrawal is more likely if||
2094|070|H|you have used dexmethylphenidate for a long time or in high||
2094|071|H|doses. Tell your doctor or pharmacist right away if you have||
2094|072|H|withdrawal.||
2094|073|H|   When this medication is used for a long time, it may not work||
2094|074|H|as well. Talk with your doctor if this medication stops working||
2094|075|H|well.||
2094|076|H|   Though it helps many people, this medication may sometimes||
2094|077|H|cause addiction. This risk may be higher if you have a substance||
2094|078|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2094|079|H|Take this medication exactly as prescribed to lower the risk of||
2094|080|H|addiction. Ask your doctor or pharmacist for more details.||
2094|081|H|   Tell your doctor if your condition does not get better or if||
2094|082|H|it gets worse.||
2094|083|B|||
2094|084|S|SIDE EFFECTS:  Trouble sleeping, nervousness, nausea, stomach||
2094|085|S|pain, headache, loss of appetite, weight loss, or dizziness may||
2094|086|S|occur. If any of these effects last or get worse, tell your||
2094|087|S|doctor or pharmacist promptly.||
2094|088|S|   Remember that this medication has been prescribed because your||
2094|089|S|doctor has judged that the benefit to you is greater than the||
2094|090|S|risk of side effects. Many people using this medication do not||
2094|091|S|have serious side effects.||
2094|092|S|   This medication may raise your blood pressure. Check your||
2094|093|S|blood pressure regularly and tell your doctor if the results are||
2094|094|S|high.||
2094|095|S|   Tell your doctor right away if you have any serious side||
2094|096|S|effects, including: signs of blood flow problems in the fingers||
2094|097|S|or toes (such as coldness, numbness, pain, or skin color||
2094|098|S|changes), unusual wounds on the fingers or toes,||
2094|099|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
2094|100|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
2094|101|S|thoughts of suicide), uncontrolled muscle movements (such as||
2094|102|S|twitching, shaking), sudden outbursts of words/sounds that are||
2094|103|S|hard to control, vision changes (such as blurred vision).||
2094|104|S|   Get medical help right away if you have any very serious side||
2094|105|S|effects, including: fainting, seizure, symptoms of a heart attack||
2094|106|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
2094|107|S|sweating), symptoms of a stroke (such as weakness on one side of||
2094|108|S|the body, trouble speaking, sudden vision changes, confusion).||
2094|109|S|   Rarely, males (including young boys and teens) may have a||
2094|110|S|painful or prolonged erection lasting 4 or more hours while using||
2094|111|S|this medication. Caregivers/parents should also be watchful for||
2094|112|S|this serious side effect in boys. If a painful or prolonged||
2094|113|S|erection occurs, stop using this drug and get medical help right||
2094|114|S|away, or permanent problems could occur. Ask your doctor or||
2094|115|S|pharmacist for more details.||
2094|116|S|   A very serious allergic reaction to this drug is rare.||
2094|117|S|However, get medical help right away if you notice any symptoms||
2094|118|S|of a serious allergic reaction, including: rash, itching/swelling||
2094|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2094|120|S|breathing.||
2094|121|S|   This is not a complete list of possible side effects. If you||
2094|122|S|notice other effects not listed above, contact your doctor or||
2094|123|S|pharmacist.||
2094|124|S|   In the US -||
2094|125|S|   Call your doctor for medical advice about side effects. You||
2094|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2094|127|S|www.fda.gov/medwatch.||
2094|128|S|   In Canada - Call your doctor for medical advice about side||
2094|129|S|effects. You may report side effects to Health Canada at||
2094|130|S|1-866-234-2345.||
2094|131|B|||
2094|132|P|PRECAUTIONS:  See also Warning section.||
2094|133|P|   Before taking dexmethylphenidate, tell your doctor or||
2094|134|P|pharmacist if you are allergic to it; or to methylphenidate; or||
2094|135|P|if you have any other allergies. This product may contain||
2094|136|P|inactive ingredients, which can cause allergic reactions or other||
2094|137|P|problems. Talk to your pharmacist for more details.||
2094|138|P|   Before using this medication, tell your doctor or pharmacist||
2094|139|P|your medical history, especially of: high blood pressure, blood||
2094|140|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
2094|141|P|problems (such as irregular heartbeat, heart failure, previous||
2094|142|P|heart attack, problems with heart structure), family history of||
2094|143|P|heart problems (such as sudden cardiac death, irregular||
2094|144|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
2094|145|P|agitation), personal/family history of mental/mood disorders||
2094|146|P|(such as bipolar disorder, depression, psychosis, suicidal||
2094|147|P|thoughts), personal/family history of uncontrolled muscle||
2094|148|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
2094|149|P|(hyperthyroidism), seizure disorder.||
2094|150|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2094|151|P|can make you more dizzy. Do not drive, use machinery, or do||
2094|152|P|anything that needs alertness until you can do it safely. Limit||
2094|153|P|alcoholic beverages. Talk to your doctor if you are using||
2094|154|P|marijuana (cannabis).||
2094|155|P|   Before having surgery, tell your doctor or dentist about all||
2094|156|P|the products you use (including prescription drugs,||
2094|157|P|nonprescription drugs, and herbal products).||
2094|158|P|   If used for a long time, this drug may affect a child's growth||
2094|159|P|rate, weight, and final adult height. To reduce the risk, the||
2094|160|P|doctor may recommend briefly stopping the medication from time to||
2094|161|P|time. Check the child's weight and height regularly, and consult||
2094|162|P|your doctor or pharmacist for more details.||
2094|163|P|   Older adults may be more sensitive to the side effects of this||
2094|164|P|drug, especially trouble sleeping, weight loss, or chest pain.||
2094|165|P|   During pregnancy, this medication should be used only when||
2094|166|P|clearly needed. Discuss the risks and benefits with your doctor.||
2094|167|P|   This drug passes into breast milk. Consult your doctor before||
2094|168|P|breastfeeding.||
2094|169|B|||
2094|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2094|171|I|medications work or increase your risk for serious side effects.||
2094|172|I|This document does not contain all possible drug interactions.||
2094|173|I|Keep a list of all the products you use (including||
2094|174|I|prescription/nonprescription drugs and herbal products) and share||
2094|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
2094|176|I|the dosage of any medicines without your doctor's approval.||
2094|177|I|   Taking MAO inhibitors with this medication may cause a serious||
2094|178|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2094|179|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2094|180|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2094|181|I|selegiline, tranylcypromine) during treatment with this||
2094|182|I|medication. Most MAO inhibitors should also not be taken for two||
2094|183|I|weeks before treatment with this medication. Ask your doctor when||
2094|184|I|to start or stop taking this medication.||
2094|185|I|   Dexmethylphenidate is very similar to methylphenidate. Do not||
2094|186|I|use medications containing methylphenidate while using||
2094|187|I|dexmethylphenidate.||
2094|188|I|   This medication may interfere with certain medical/lab tests||
2094|189|I|(such as brain scan for Parkinson's disease), possibly causing||
2094|190|I|false test results. Make sure lab personnel and all your doctors||
2094|191|I|know you use this drug.||
2094|192|B|||
2094|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2094|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2094|195|O|poison control center right away. US residents can call||
2094|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2094|197|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
2094|198|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
2094|199|O|loss of consciousness.||
2094|200|B|||
2094|201|N|NOTES:  Do not share this medication with others. Sharing it is||
2094|202|N|against the law.||
2094|203|N|   Lab and/or medical tests (such as blood pressure, complete||
2094|204|N|blood count, height/weight monitoring in children) may be done||
2094|205|N|while you are taking this medication. Keep all medical and lab||
2094|206|N|appointments. Consult your doctor for more details.||
2094|207|B|||
2094|208|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2094|209|D|remember. If it is near bedtime or near the time of the next||
2094|210|D|dose, skip the missed dose. Take your next dose at the regular||
2094|211|D|time. Do not double the dose to catch up.||
2094|212|B|||
2094|213|R|STORAGE:  Store at room temperature away from light and moisture.||
2094|214|R|Do not store in the bathroom. Keep all medications away from||
2094|215|R|children and pets.||
2094|216|R|   Do not flush medications down the toilet or pour them into a||
2094|217|R|drain unless instructed to do so. Properly discard this product||
2094|218|R|when it is expired or no longer needed. Consult your pharmacist||
2094|219|R|or local waste disposal company.||
2094|220|B|||
2094|221|A|Information last revised October 2024.||
2094|222|A|Copyright(c) 2025 First Databank, Inc.||
2094|223|B|||
2095|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2095|002|Z|does NOT have all possible information about this product. This||
2095|003|Z|information does not assure that this product is safe, effective,||
2095|004|Z|or appropriate for you. This information is not individual||
2095|005|Z|medical advice and does not substitute for the advice of your||
2095|006|Z|health care professional. Always ask your health care||
2095|007|Z|professional for complete information about this product and your||
2095|008|Z|specific health needs.||
2095|009|B|||
2095|010|T|ESCITALOPRAM - ORAL||
2095|011|F|(ES-sye-TAL-oh-pram)||
2095|012|B|||
2095|013|C|COMMON BRAND NAME(S): Lexapro||
2095|014|B|||
2095|015|W|WARNING:  Antidepressant medications are used to treat a variety||
2095|016|W|of conditions, including depression and other mental/mood||
2095|017|W|disorders. These medications can help prevent suicidal||
2095|018|W|thoughts/attempts and provide other important benefits. However,||
2095|019|W|studies have shown that a small number of people (especially||
2095|020|W|people younger than 25) who take antidepressants for any||
2095|021|W|condition may experience worsening depression, other mental/mood||
2095|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
2095|023|W|talk with the doctor about the risks and benefits of||
2095|024|W|antidepressant medication (especially for people younger than||
2095|025|W|25), even if treatment is not for a mental/mood condition.||
2095|026|W|   Tell the doctor right away if you notice worsening||
2095|027|W|depression/other psychiatric conditions, unusual behavior changes||
2095|028|W|(including possible suicidal thoughts/attempts), or other||
2095|029|W|mental/mood changes (including new/worsening anxiety, panic||
2095|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2095|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
2095|032|W|especially watchful for these symptoms when a new antidepressant||
2095|033|W|is started or when the dose is changed.||
2095|034|B|||
2095|035|U|USES:  This medication is used to treat certain mental/mood||
2095|036|U|disorders (such as depression, anxiety). Escitalopram belongs to||
2095|037|U|a class of drugs known as selective serotonin reuptake inhibitors||
2095|038|U|(SSRIs). It works by helping to restore the balance of a certain||
2095|039|U|natural substance (serotonin) in the brain.||
2095|040|B|||
2095|041|V|OTHER USES:  This section contains uses of this drug that are not||
2095|042|V|listed in the approved US professional labeling for the drug but||
2095|043|V|that may be prescribed by your health care professional. Use this||
2095|044|V|drug for a condition that is listed in this section only if it||
2095|045|V|has been so prescribed by your health care professional.||
2095|046|V|   This drug may also be used for other mental conditions (such||
2095|047|V|as obsessive-compulsive disorder, panic disorder) or binge eating||
2095|048|V|disorder (BED). It may also be used for hot flashes that occur||
2095|049|V|with menopause.||
2095|050|B|||
2095|051|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2095|052|H|Patient Information Leaflet provided by your pharmacist before||
2095|053|H|you start taking escitalopram and each time you get a refill. If||
2095|054|H|you have any questions, ask your doctor or pharmacist.||
2095|055|H|   Take this medication by mouth with or without food as directed||
2095|056|H|by your doctor, usually once daily in the morning or evening. The||
2095|057|H|dosage is based on your medical condition, response to treatment,||
2095|058|H|age, and other medications you may be taking. Be sure to tell||
2095|059|H|your doctor and pharmacist about all the products you use||
2095|060|H|(including prescription drugs, nonprescription drugs, and herbal||
2095|061|H|products).||
2095|062|H|   If you are taking the capsule form of this medication, swallow||
2095|063|H|the capsules whole. Do not open, crush, or chew the capsules.||
2095|064|H|   If you are using the liquid form of this medication, carefully||
2095|065|H|measure the dose using a special measuring device/spoon. Do not||
2095|066|H|use a household spoon because you may not get the correct dose.||
2095|067|H|   To reduce your risk of side effects, your doctor may direct||
2095|068|H|you to start taking this drug at a low dose and gradually||
2095|069|H|increase your dose. Follow your doctor's instructions carefully.||
2095|070|H|Do not increase your dose or use this drug more often or for||
2095|071|H|longer than prescribed. Your condition will not improve any||
2095|072|H|faster, and your risk of side effects will increase. Take this||
2095|073|H|medication regularly to get the most benefit from it. To help you||
2095|074|H|remember, take it at the same time each day.||
2095|075|H|   Keep taking this medication even if you feel well. Do not stop||
2095|076|H|taking this medication without consulting your doctor. Some||
2095|077|H|conditions may become worse when this drug is suddenly stopped.||
2095|078|H|Also, you may experience symptoms such as mood swings, headache,||
2095|079|H|tiredness, sleep changes, and brief feelings similar to electric||
2095|080|H|shock. To prevent these symptoms while you are stopping treatment||
2095|081|H|with this drug, your doctor may reduce your dose gradually.||
2095|082|H|Consult your doctor or pharmacist for more details. Report any||
2095|083|H|new or worsening symptoms right away.||
2095|084|H|   It may take 1 to 2 weeks to feel a benefit from this drug and||
2095|085|H|4 weeks to feel the full benefit of this medication. Tell your||
2095|086|H|doctor if your condition does not get better or if it gets worse.||
2095|087|B|||
2095|088|S|SIDE EFFECTS:  See also Warning section.||
2095|089|S|   Nausea, dry mouth, trouble sleeping, constipation, tiredness,||
2095|090|S|drowsiness, dizziness, and increased sweating may occur. If any||
2095|091|S|of these effects last or get worse, tell your doctor promptly.||
2095|092|S|   Remember that this medication has been prescribed because your||
2095|093|S|doctor has judged that the benefit to you is greater than the||
2095|094|S|risk of side effects. Many people using this medication do not||
2095|095|S|have serious side effects.||
2095|096|S|   Tell your doctor right away if you have any serious side||
2095|097|S|effects, including: decreased interest in sex, changes in sexual||
2095|098|S|ability, easy bleeding/bruising.||
2095|099|S|   Get medical help right away if you have any very serious side||
2095|100|S|effects, including: black stools, fainting, fast/irregular||
2095|101|S|heartbeat, vomit that looks like coffee grounds, seizures, eye||
2095|102|S|pain/swelling/redness, widened pupils, vision changes (such as||
2095|103|S|seeing rainbows around lights at night, blurred vision).||
2095|104|S|   This medication may increase serotonin and rarely cause a very||
2095|105|S|serious condition called serotonin syndrome/toxicity. The risk||
2095|106|S|increases if you are also taking other drugs that increase||
2095|107|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2095|108|S|take (see Drug Interactions section). Get medical help right away||
2095|109|S|if you develop some of the following symptoms: fast heartbeat,||
2095|110|S|hallucinations, loss of coordination, severe dizziness, severe||
2095|111|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2095|112|S|unusual agitation/restlessness.||
2095|113|S|   Rarely, males may have a painful or prolonged erection lasting||
2095|114|S|4 or more hours. If this occurs, stop using this drug and get||
2095|115|S|medical help right away, or permanent problems could occur.||
2095|116|S|   A very serious allergic reaction to this drug is rare.||
2095|117|S|However, get medical help right away if you notice any symptoms||
2095|118|S|of a serious allergic reaction, including: rash, itching/swelling||
2095|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2095|120|S|breathing.||
2095|121|S|   This is not a complete list of possible side effects. If you||
2095|122|S|notice other effects not listed above, contact your doctor or||
2095|123|S|pharmacist.||
2095|124|S|   In the US -||
2095|125|S|   Call your doctor for medical advice about side effects. You||
2095|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2095|127|S|www.fda.gov/medwatch.||
2095|128|S|   In Canada - Call your doctor for medical advice about side||
2095|129|S|effects. You may report side effects to Health Canada at||
2095|130|S|1-866-234-2345.||
2095|131|B|||
2095|132|P|PRECAUTIONS:  Before taking escitalopram, tell your doctor or||
2095|133|P|pharmacist if you are allergic to it; or to citalopram; or if you||
2095|134|P|have any other allergies. This product may contain inactive||
2095|135|P|ingredients, which can cause allergic reactions or other||
2095|136|P|problems. Talk to your pharmacist for more details.||
2095|137|P|   Before using this medication, tell your doctor or pharmacist||
2095|138|P|your medical history, especially of: personal or family history||
2095|139|P|of bipolar/manic-depressive disorder, personal or family history||
2095|140|P|of suicide attempts, liver disease, seizures, bleeding problems,||
2095|141|P|low sodium in the blood (hyponatremia), personal or family||
2095|142|P|history of glaucoma (angle-closure type).||
2095|143|P|   Escitalopram may cause a condition that affects the heart||
2095|144|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2095|145|P|serious (rarely fatal) fast/irregular heartbeat and other||
2095|146|P|symptoms (such as severe dizziness, fainting) that need medical||
2095|147|P|attention right away.||
2095|148|P|   The risk of QT prolongation may be increased if you have||
2095|149|P|certain medical conditions or are taking other drugs that may||
2095|150|P|cause QT prolongation. Before using escitalopram, tell your||
2095|151|P|doctor or pharmacist of all the drugs you take and if you have||
2095|152|P|any of the following conditions: certain heart problems (heart||
2095|153|P|failure, slow heartbeat, recent heart attack, QT prolongation in||
2095|154|P|the EKG), family history of certain heart problems (QT||
2095|155|P|prolongation in the EKG, sudden cardiac death).||
2095|156|P|   Low levels of potassium or magnesium in the blood may also||
2095|157|P|increase your risk of QT prolongation. This risk may increase if||
2095|158|P|you use certain drugs (such as diuretics/"water pills") or if you||
2095|159|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2095|160|P|Talk to your doctor about using escitalopram safely.||
2095|161|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2095|162|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2095|163|P|machinery, or do anything that needs alertness until you can do||
2095|164|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2095|165|P|are using marijuana (cannabis).||
2095|166|P|   The liquid form of this medication may contain sugar and/or||
2095|167|P|aspartame. Caution is advised if you have diabetes,||
2095|168|P|phenylketonuria (PKU), or any other condition that requires you||
2095|169|P|to limit/avoid these substances in your diet. Ask your doctor or||
2095|170|P|pharmacist about using this medication safely.||
2095|171|P|   Before having surgery, tell your doctor or dentist about all||
2095|172|P|the products you use (including prescription drugs,||
2095|173|P|nonprescription drugs, and herbal products).||
2095|174|P|   Older adults may be more sensitive to the side effects of this||
2095|175|P|drug, especially QT prolongation (see above), loss of||
2095|176|P|coordination, or bleeding. They may also be more likely to lose||
2095|177|P|too much salt (hyponatremia), especially if they are also taking||
2095|178|P|"water pills" (diuretics) with this medication. Loss of||
2095|179|P|coordination can increase the risk of falling.||
2095|180|P|   Children may be more sensitive to the side effects of this||
2095|181|P|drug, especially loss of appetite and weight loss. Monitor weight||
2095|182|P|and height in children who are taking this drug.||
2095|183|P|   During pregnancy, this medication should be used only when||
2095|184|P|clearly needed. It may harm an unborn baby. Also, babies born to||
2095|185|P|mothers who have used this drug during the last 3 months of||
2095|186|P|pregnancy may rarely develop withdrawal symptoms such as||
2095|187|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
2095|188|P|constant crying. If you notice any of these symptoms in your||
2095|189|P|newborn, tell the doctor promptly.||
2095|190|P|   Since untreated mental/mood problems (such as depression,||
2095|191|P|anxiety, obsessive-compulsive disorder, panic disorder) can be a||
2095|192|P|serious condition, do not stop using this medication unless||
2095|193|P|directed by your doctor. If you are planning pregnancy, become||
2095|194|P|pregnant, or think you may be pregnant, immediately discuss with||
2095|195|P|your doctor the benefits and risks of using this medication||
2095|196|P|during pregnancy.||
2095|197|P|   This medication passes into breast milk and may have||
2095|198|P|undesirable effects on a nursing infant. Consult your doctor||
2095|199|P|before breastfeeding.||
2095|200|B|||
2095|201|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2095|202|I|medications work or increase your risk for serious side effects.||
2095|203|I|This document does not contain all possible drug interactions.||
2095|204|I|Keep a list of all the products you use (including||
2095|205|I|prescription/nonprescription drugs and herbal products) and share||
2095|206|I|it with your doctor and pharmacist. Do not start, stop, or change||
2095|207|I|the dosage of any medicines without your doctor's approval.||
2095|208|I|   Some products that may interact with this drug are: other||
2095|209|I|drugs that can cause bleeding/bruising (including antiplatelet||
2095|210|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
2095|211|I|"blood thinners" such as dabigatran/warfarin).||
2095|212|I|   Aspirin can increase the risk of bleeding when used with this||
2095|213|I|medication. However, if your doctor has told you to take low-dose||
2095|214|I|aspirin to prevent heart attack or stroke (usually 81-162||
2095|215|I|milligrams a day), you should keep taking the aspirin unless your||
2095|216|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2095|217|I|details.||
2095|218|I|   Taking MAO inhibitors with this medication may cause a serious||
2095|219|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2095|220|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2095|221|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2095|222|I|selegiline, tranylcypromine) during treatment with this||
2095|223|I|medication. Most MAO inhibitors should also not be taken for two||
2095|224|I|weeks before and after treatment with this medication. Ask your||
2095|225|I|doctor when to start or stop taking this medication.||
2095|226|I|   The risk of serotonin syndrome/toxicity increases if you are||
2095|227|I|also taking other drugs that increase serotonin. Examples include||
2095|228|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
2095|229|I|antidepressants (including other SSRIs such as||
2095|230|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
2095|231|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
2095|232|I|may be more likely when you start or increase the dose of these||
2095|233|I|drugs.||
2095|234|I|   Tell your doctor or pharmacist if you are taking other||
2095|235|I|products that cause drowsiness including alcohol, marijuana||
2095|236|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
2095|237|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
2095|238|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
2095|239|I|codeine).||
2095|240|I|   Check the labels on all your medicines (such as allergy,||
2095|241|I|pain/fever reducers, or cough-and-cold products) because they may||
2095|242|I|contain ingredients that cause drowsiness or increase the risk of||
2095|243|I|bleeding. Ask your pharmacist about using those products safely.||
2095|244|I|   Many drugs besides escitalopram may affect the heart rhythm||
2095|245|I|(QT prolongation), including amiodarone, pimozide, procainamide,||
2095|246|I|quinidine, sotalol, among others.||
2095|247|I|   Escitalopram is very similar to citalopram. Do not use||
2095|248|I|medications containing citalopram while using escitalopram.||
2095|249|I|   This medication may interfere with certain medical/lab tests||
2095|250|I|(such as brain scan for Parkinson's disease), possibly causing||
2095|251|I|false test results. Make sure lab personnel and all your doctors||
2095|252|I|know you use this drug.||
2095|253|B|||
2095|254|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2095|255|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2095|256|O|poison control center right away. US residents can call||
2095|257|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2095|258|B|||
2095|259|N|NOTES:  Do not share this medication with others.||
2095|260|N|   Keep all medical and lab appointments.||
2095|261|B|||
2095|262|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2095|263|D|remember. If it is near the time of the next dose, skip the||
2095|264|D|missed dose. Take your next dose at the regular time. Do not||
2095|265|D|double the dose to catch up.||
2095|266|B|||
2095|267|R|STORAGE:  Store at room temperature away from light and moisture.||
2095|268|R|Do not store in the bathroom. Keep all medications away from||
2095|269|R|children and pets.||
2095|270|R|   Do not flush medications down the toilet or pour them into a||
2095|271|R|drain unless instructed to do so. Properly discard this product||
2095|272|R|when it is expired or no longer needed. Consult your pharmacist||
2095|273|R|or local waste disposal company.||
2095|274|B|||
2095|275|A|Information last revised September 2025.||
2095|276|A|Copyright(c) 2025 First Databank, Inc.||
2095|277|B|||
2096|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2096|002|Z|does NOT have all possible information about this product. This||
2096|003|Z|information does not assure that this product is safe, effective,||
2096|004|Z|or appropriate for you. This information is not individual||
2096|005|Z|medical advice and does not substitute for the advice of your||
2096|006|Z|health care professional. Always ask your health care||
2096|007|Z|professional for complete information about this product and your||
2096|008|Z|specific health needs.||
2096|009|B|||
2096|010|T|GUAIFENESIN/PSEUDOEPHEDRINE - ORAL||
2096|011|F|(gweye-FEN-eh-sin/sue-doh-eff-ED-rin)||
2096|012|B|||
2096|013|C|COMMON BRAND NAME(S): Duratuss, Maxifed||
2096|014|B|||
2096|015|U|USES:  This combination medication is used to temporarily treat||
2096|016|U|cough and runny/stuffy nose (nasal congestion) caused by||
2096|017|U|infections (such as the common cold), allergies (such as hay||
2096|018|U|fever), and other breathing illnesses. This product is usually||
2096|019|U|not used for ongoing cough from smoking or long-term breathing||
2096|020|U|problems (such as chronic bronchitis, emphysema) unless directed||
2096|021|U|by your doctor. Guaifenesin is an expectorant. It works by||
2096|022|U|thinning and loosening mucus in the airways, clearing congestion,||
2096|023|U|and making breathing easier. Pseudoephedrine is a decongestant||
2096|024|U|(sympathomimetic). It reduces nasal congestion by narrowing the||
2096|025|U|blood vessels in the nose.||
2096|026|U|   If you are self-treating with this medication, it is important||
2096|027|U|to read the package instructions carefully before you start using||
2096|028|U|this product to be sure it is right for you. (See also||
2096|029|U|Precautions section.)||
2096|030|U|   Cough-and-cold products have not been shown to be safe or||
2096|031|U|effective in children younger than 6 years. Do not use this||
2096|032|U|product to treat cold symptoms in children younger than 6 years||
2096|033|U|unless specifically directed by the doctor. Some products (such||
2096|034|U|as long-acting tablets/capsules) are not recommended for use in||
2096|035|U|children younger than 12 years. Ask your doctor or pharmacist for||
2096|036|U|more details about using your product safely.||
2096|037|U|   These products do not cure or shorten the length of the common||
2096|038|U|cold and may cause serious side effects. To decrease the risk for||
2096|039|U|serious side effects, carefully follow all dosage directions. Do||
2096|040|U|not give other cough-and-cold medication that might contain the||
2096|041|U|same or similar ingredients (see also Drug Interactions section).||
2096|042|U|Ask the doctor or pharmacist about other ways to relieve cough||
2096|043|U|and cold symptoms (such as drinking enough fluids, using a||
2096|044|U|humidifier or saline nose drops/spray).||
2096|045|B|||
2096|046|H|HOW TO USE:  Take this medication by mouth with or without food,||
2096|047|H|as directed by your doctor. If you are self-treating, follow all||
2096|048|H|directions on the product package. To prevent trouble sleeping,||
2096|049|H|do not take this medication close to bedtime. If you have any||
2096|050|H|questions, ask your doctor or pharmacist.||
2096|051|H|   If you are using the liquid form of this medication, carefully||
2096|052|H|measure the dose using a special measuring device/spoon. Do not||
2096|053|H|use a household spoon because you may not get the correct dose.||
2096|054|H|   Guaifenesin may have a bitter taste. Swallow capsules and||
2096|055|H|tablets whole. Some tablets may be split if they have a score||
2096|056|H|line and your doctor or pharmacist tells you to do so. Chewable||
2096|057|H|tablets may be swallowed whole or chewed.||
2096|058|H|   The dosage is based on your age, medical condition, and||
2096|059|H|response to treatment. Do not increase your dose or take this||
2096|060|H|drug more often than directed.||
2096|061|H|   Drink plenty of fluids while taking this medication. Fluids||
2096|062|H|will help to break up mucus and clear congestion.||
2096|063|H|   Caffeine can increase the side effects of this medication.||
2096|064|H|Avoid drinking large amounts of beverages containing caffeine||
2096|065|H|(coffee, tea, colas), eating large amounts of chocolate, or||
2096|066|H|taking nonprescription products that contain caffeine.||
2096|067|H|   Tell your doctor if your condition is accompanied by headache||
2096|068|H|that doesn't go away, fever, severe sore throat, rash, or if it||
2096|069|H|lasts, returns, or gets worse after 7 days. These may be signs of||
2096|070|H|a serious medical problem. Get medical help right away if you||
2096|071|H|think you may have a serious medical problem.||
2096|072|B|||
2096|073|S|SIDE EFFECTS:  Nausea or headache may occur. If either of these||
2096|074|S|effects lasts or gets worse, tell your doctor or pharmacist||
2096|075|S|promptly.||
2096|076|S|   If your doctor has directed you to use this medication,||
2096|077|S|remember that your doctor has judged that the benefit to you is||
2096|078|S|greater than the risk of side effects. Many people using this||
2096|079|S|medication do not have serious side effects.||
2096|080|S|   This medication may raise your blood pressure. Check your||
2096|081|S|blood pressure regularly and tell your doctor if the results are||
2096|082|S|high.||
2096|083|S|   Tell your doctor right away if you have any serious side||
2096|084|S|effects, including: dizziness, fainting, fast/irregular/pounding||
2096|085|S|heartbeat, mental/mood changes (such as anxiety, confusion,||
2096|086|S|nervousness, irritability), shaking (tremor), trouble sleeping,||
2096|087|S|difficult/painful urination.||
2096|088|S|   A very serious allergic reaction to this drug is rare.||
2096|089|S|However, get medical help right away if you notice any symptoms||
2096|090|S|of a serious allergic reaction, including: rash, itching/swelling||
2096|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2096|092|S|breathing.||
2096|093|S|   This is not a complete list of possible side effects. If you||
2096|094|S|notice other effects not listed above, contact your doctor or||
2096|095|S|pharmacist.||
2096|096|S|   In the US -||
2096|097|S|   Call your doctor for medical advice about side effects. You||
2096|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2096|099|S|www.fda.gov/medwatch.||
2096|100|S|   In Canada - Call your doctor for medical advice about side||
2096|101|S|effects. You may report side effects to Health Canada at||
2096|102|S|1-866-234-2345.||
2096|103|B|||
2096|104|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2096|105|P|pharmacist if you are allergic to pseudoephedrine or guaifenesin;||
2096|106|P|or if you have any other allergies. Also tell your doctor if you||
2096|107|P|have had a bad reaction to similar drugs (sympathomimetics such||
2096|108|P|as ephedrine, phenylephrine). This product may contain inactive||
2096|109|P|ingredients, which can cause allergic reactions or other||
2096|110|P|problems. Talk to your pharmacist for more details.||
2096|111|P|   Before using this medication, tell your doctor or pharmacist||
2096|112|P|your medical history, especially of: breathing problems (such as||
2096|113|P|emphysema, chronic bronchitis, asthma, smoker's cough), cough||
2096|114|P|with blood or large amounts of mucus, high blood pressure, heart||
2096|115|P|disease (such as chest pain, heart failure, heart attack),||
2096|116|P|fast/slow/irregular heartbeat, diabetes, a certain eye problem||
2096|117|P|(glaucoma), kidney problems, difficulty urinating (such as due to||
2096|118|P|enlarged prostate), overactive thyroid (hyperthyroidism).||
2096|119|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2096|120|P|can make you more dizzy. Do not drive, use machinery, or do||
2096|121|P|anything that needs alertness until you can do it safely. Limit||
2096|122|P|alcoholic beverages. Talk to your doctor if you are using||
2096|123|P|marijuana (cannabis).||
2096|124|P|   Liquid products or chewable tablets may contain sugar and/or||
2096|125|P|aspartame. Liquid products may also contain alcohol. Caution is||
2096|126|P|advised if you have diabetes, liver disease, phenylketonuria||
2096|127|P|(PKU), or any other condition that requires you to limit/avoid||
2096|128|P|these substances in your diet. Ask your doctor or pharmacist||
2096|129|P|about using this product safely.||
2096|130|P|   Before having surgery, tell your doctor or dentist about all||
2096|131|P|the products you use (including prescription drugs,||
2096|132|P|nonprescription drugs, and herbal products).||
2096|133|P|   Children may be more sensitive to the side effects of this||
2096|134|P|drug, especially nervousness, irritability, and high blood||
2096|135|P|pressure.||
2096|136|P|   Older adults may be more sensitive to the side effects of this||
2096|137|P|drug, especially fast/irregular heartbeat, dizziness, problems||
2096|138|P|urinating, trouble sleeping, or confusion.||
2096|139|P|   During pregnancy, this medication should be used only when||
2096|140|P|clearly needed. Discuss the risks and benefits with your doctor.||
2096|141|P|   Pseudoephedrine passes into breast milk. It is unknown if||
2096|142|P|guaifenesin passes into breast milk. Consult your doctor before||
2096|143|P|breastfeeding.||
2096|144|B|||
2096|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2096|146|I|medications work or increase your risk for serious side effects.||
2096|147|I|This document does not contain all possible drug interactions.||
2096|148|I|Keep a list of all the products you use (including||
2096|149|I|prescription/nonprescription drugs and herbal products) and share||
2096|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
2096|151|I|the dosage of any medicines without your doctor's approval.||
2096|152|I|   Taking MAO inhibitors with this medication may cause a serious||
2096|153|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2096|154|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2096|155|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2096|156|I|selegiline, tranylcypromine) during treatment with this||
2096|157|I|medication. Most MAO inhibitors should also not be taken for two||
2096|158|I|weeks before treatment with this medication. Ask your doctor when||
2096|159|I|to start or stop taking this medication.||
2096|160|I|   Pseudoephedrine and guaifenesin are available in both||
2096|161|I|prescription and nonprescription products. Check the labels of||
2096|162|I|all your medications carefully to make sure you are not taking||
2096|163|I|more than one product containing these medications.||
2096|164|I|   This medication may interfere with certain lab tests (such as||
2096|165|I|urine levels of certain acids), possibly causing false test||
2096|166|I|results. Make sure lab personnel and all your doctors know you||
2096|167|I|use this drug.||
2096|168|B|||
2096|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2096|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2096|171|O|poison control center right away. US residents can call||
2096|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2096|173|O|Symptoms of overdose may include: severe dizziness/fainting, fast||
2096|174|O|irregular heartbeat, slow/fast/shallow breathing, hallucinations,||
2096|175|O|seizures.||
2096|176|B|||
2096|177|N|NOTES:  If your doctor prescribed this medication, do not share||
2096|178|N|this medication with others.||
2096|179|N|   Keep all medical and lab appointments.||
2096|180|N|   This medication is for temporary use only. Do not take this||
2096|181|N|medication for more than 7 days unless your doctor tells you to||
2096|182|N|do so. Tell your doctor if your condition lasts longer than 7||
2096|183|N|days.||
2096|184|B|||
2096|185|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2096|186|D|remember. If it is near the time of the next dose, skip the||
2096|187|D|missed dose. Take your next dose at the regular time. Do not||
2096|188|D|double the dose to catch up.||
2096|189|B|||
2096|190|R|STORAGE:  Store at room temperature away from light and moisture.||
2096|191|R|Do not store in the bathroom. Do not freeze liquid forms of this||
2096|192|R|medication. Different brands of this medication have different||
2096|193|R|storage needs. Check the product package for instructions on how||
2096|194|R|to store your brand, or ask your pharmacist. Keep all medications||
2096|195|R|away from children and pets.||
2096|196|R|   Do not flush medications down the toilet or pour them into a||
2096|197|R|drain unless instructed to do so. Properly discard this product||
2096|198|R|when it is expired or no longer needed. Consult your pharmacist||
2096|199|R|or local waste disposal company.||
2096|200|B|||
2096|201|A|Information last revised September 2025.||
2096|202|A|Copyright(c) 2025 First Databank, Inc.||
2096|203|B|||
2097|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2097|002|Z|does NOT have all possible information about this product. This||
2097|003|Z|information does not assure that this product is safe, effective,||
2097|004|Z|or appropriate for you. This information is not individual||
2097|005|Z|medical advice and does not substitute for the advice of your||
2097|006|Z|health care professional. Always ask your health care||
2097|007|Z|professional for complete information about this product and your||
2097|008|Z|specific health needs.||
2097|009|B|||
2097|010|T|LEFAMULIN - INJECTION||
2097|011|F|(le-FAM-ue-lin)||
2097|012|B|||
2097|013|C|COMMON BRAND NAME(S): Xenleta||
2097|014|B|||
2097|015|U|USES:  This medication is used to treat a wide variety of||
2097|016|U|bacterial infections. It works by stopping the growth of||
2097|017|U|bacteria.||
2097|018|B|||
2097|019|H|HOW TO USE:  This medication is given by injection into a vein as||
2097|020|H|directed by your doctor, usually every 12 hours. The injection is||
2097|021|H|given by a health care provider, usually over 60 minutes.||
2097|022|H|   The dosage and length of treatment are based on your medical||
2097|023|H|condition and response to treatment. As soon as you are able to||
2097|024|H|take medications by mouth, your doctor may switch you to an||
2097|025|H|antibiotic that is taken by mouth.||
2097|026|H|   If you are using this medication at home, learn all||
2097|027|H|preparation and usage instructions from your health care||
2097|028|H|professional. Before using, check this product for particles or||
2097|029|H|discoloration. If either is present, do not use the liquid. Learn||
2097|030|H|how to store and discard medical supplies safely.||
2097|031|H|   For the best effect, use this antibiotic at evenly spaced||
2097|032|H|times. To help you remember, use this medication at the same||
2097|033|H|times every day.||
2097|034|H|   Continue to use this medication until the full prescribed||
2097|035|H|amount is finished, even if symptoms disappear after a few days.||
2097|036|H|Stopping the medication too early may result in a return of the||
2097|037|H|infection.||
2097|038|H|   Tell your doctor if your condition lasts or gets worse.||
2097|039|B|||
2097|040|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. Pain,||
2097|041|S|redness, or irritation at the injection site may also occur. If||
2097|042|S|any of these effects last or get worse, tell your doctor or||
2097|043|S|pharmacist promptly.||
2097|044|S|   Remember that this medication has been prescribed because your||
2097|045|S|doctor has judged that the benefit to you is greater than the||
2097|046|S|risk of side effects. Many people using this medication do not||
2097|047|S|have serious side effects.||
2097|048|S|   Get medical help right away if you have any very serious side||
2097|049|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2097|050|S|fainting.||
2097|051|S|   This medication may rarely cause a severe intestinal condition||
2097|052|S|due to a bacteria called C. difficile. This condition may occur||
2097|053|S|during treatment or weeks to months after treatment has stopped.||
2097|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2097|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2097|056|S|stool.||
2097|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2097|058|S|products because they may make symptoms worse.||
2097|059|S|   Use of this medication for prolonged or repeated periods may||
2097|060|S|result in oral thrush or a new yeast infection. Contact your||
2097|061|S|doctor if you notice white patches in your mouth, a change in||
2097|062|S|vaginal discharge, or other new symptoms.||
2097|063|S|   A very serious allergic reaction to this drug is rare.||
2097|064|S|However, get medical help right away if you notice any symptoms||
2097|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2097|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2097|067|S|breathing.||
2097|068|S|   This is not a complete list of possible side effects. If you||
2097|069|S|notice other effects not listed above, contact your doctor or||
2097|070|S|pharmacist.||
2097|071|S|   In the US -||
2097|072|S|   Call your doctor for medical advice about side effects. You||
2097|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2097|074|S|www.fda.gov/medwatch.||
2097|075|S|   In Canada - Call your doctor for medical advice about side||
2097|076|S|effects. You may report side effects to Health Canada at||
2097|077|S|1-866-234-2345.||
2097|078|B|||
2097|079|P|PRECAUTIONS:  Before using lefamulin, tell your doctor or||
2097|080|P|pharmacist if you are allergic to it; or if you have any other||
2097|081|P|allergies. This product may contain inactive ingredients, which||
2097|082|P|can cause allergic reactions or other problems. Talk to your||
2097|083|P|pharmacist for more details.||
2097|084|P|   Before using this medication, tell your doctor or pharmacist||
2097|085|P|your medical history, especially of: liver problems.||
2097|086|P|   Lefamulin may cause a condition that affects the heart rhythm||
2097|087|P|(QT prolongation). QT prolongation can rarely cause serious||
2097|088|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2097|089|P|as severe dizziness, fainting) that need medical attention right||
2097|090|P|away.||
2097|091|P|   The risk of QT prolongation may be increased if you have||
2097|092|P|certain medical conditions or are taking other drugs that may||
2097|093|P|cause QT prolongation. Before using lefamulin, tell your doctor||
2097|094|P|or pharmacist of all the drugs you take and if you have any of||
2097|095|P|the following conditions: certain heart problems (heart failure,||
2097|096|P|slow heartbeat, QT prolongation in the EKG), family history of||
2097|097|P|certain heart problems (QT prolongation in the EKG, sudden||
2097|098|P|cardiac death).||
2097|099|P|   Low levels of potassium or magnesium in the blood may also||
2097|100|P|increase your risk of QT prolongation. This risk may increase if||
2097|101|P|you use certain drugs (such as diuretics/"water pills") or if you||
2097|102|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2097|103|P|Talk to your doctor about using lefamulin safely.||
2097|104|P|   Lefamulin may cause live bacterial vaccines (such as typhoid||
2097|105|P|vaccine) to not work well. Tell your health care professional||
2097|106|P|that you are using lefamulin before having any||
2097|107|P|immunizations/vaccinations.||
2097|108|P|   Before having surgery, tell your doctor or dentist about all||
2097|109|P|the products you use (including prescription drugs,||
2097|110|P|nonprescription drugs, and herbal products).||
2097|111|P|   Older adults may be more sensitive to the side effects of this||
2097|112|P|drug, especially QT prolongation (see above).||
2097|113|P|   Tell your doctor if you are pregnant or plan to become||
2097|114|P|pregnant. You should not become pregnant while using lefamulin.||
2097|115|P|Lefamulin may harm an unborn baby. Your doctor should order a||
2097|116|P|pregnancy test before you start this medication. Ask about||
2097|117|P|reliable forms of birth control while using this medication and||
2097|118|P|for 2 days after the last dose. If you become pregnant, talk to||
2097|119|P|your doctor right away about the risks and benefits of this||
2097|120|P|medication.||
2097|121|P|   It is unknown if this drug passes into breast milk. Because of||
2097|122|P|the possible risk to the infant, breastfeeding is not recommended||
2097|123|P|while using this drug and for 2 days after the last dose. Consult||
2097|124|P|your doctor before breastfeeding.||
2097|125|B|||
2097|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2097|127|I|medications work or increase your risk for serious side effects.||
2097|128|I|This document does not contain all possible drug interactions.||
2097|129|I|Keep a list of all the products you use (including||
2097|130|I|prescription/nonprescription drugs and herbal products) and share||
2097|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
2097|132|I|the dosage of any medicines without your doctor's approval.||
2097|133|I|   A product that may interact with this drug is: elacestrant.||
2097|134|I|   Other medications can affect the removal of lefamulin from||
2097|135|I|your body, which may affect how lefamulin works. Examples include||
2097|136|I|azole antifungals (such as fluconazole, itraconazole), HIV||
2097|137|I|protease inhibitors (such as nelfinavir), rifamycins (such as||
2097|138|I|rifabutin, rifampin), ritonavir, St. John's wort, drugs used to||
2097|139|I|treat seizures (such as carbamazepine, phenytoin), among others.||
2097|140|I|   Many drugs besides lefamulin may affect the heart rhythm (QT||
2097|141|I|prolongation), including pimozide, among others.||
2097|142|B|||
2097|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2097|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2097|145|O|poison control center right away. US residents can call||
2097|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2097|147|B|||
2097|148|N|NOTES:  Keep all medical and lab appointments.||
2097|149|B|||
2097|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2097|151|D|remember. If it is less than 8 hours before the next dose, skip||
2097|152|D|the missed dose. Take your next dose at the regular time. Do not||
2097|153|D|double the dose to catch up.||
2097|154|B|||
2097|155|R|STORAGE:  Consult the product instructions and your pharmacist||
2097|156|R|for storage details. Keep all medications away from children and||
2097|157|R|pets.||
2097|158|R|   Do not flush medications down the toilet or pour them into a||
2097|159|R|drain unless instructed to do so. Properly discard this product||
2097|160|R|when it is expired or no longer needed. Consult your pharmacist||
2097|161|R|or local waste disposal company.||
2097|162|B|||
2097|163|A|Information last revised April 2025.||
2097|164|A|Copyright(c) 2025 First Databank, Inc.||
2097|165|B|||
2098|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2098|002|Z|does NOT have all possible information about this product. This||
2098|003|Z|information does not assure that this product is safe, effective,||
2098|004|Z|or appropriate for you. This information is not individual||
2098|005|Z|medical advice and does not substitute for the advice of your||
2098|006|Z|health care professional. Always ask your health care||
2098|007|Z|professional for complete information about this product and your||
2098|008|Z|specific health needs.||
2098|009|B|||
2098|010|T|ACETAZOLAMIDE - INJECTION||
2098|011|F|(a-SEET-a-ZOE-la-mide)||
2098|012|B|||
2098|013|U|USES:  This medication is used with other medications to treat||
2098|014|U|high pressure inside the eye due to certain types of glaucoma.||
2098|015|U|Acetazolamide belongs to a class of drugs known as carbonic||
2098|016|U|anhydrase inhibitors. It works by decreasing the production of||
2098|017|U|fluid inside the eye. It is also used to decrease a buildup of||
2098|018|U|body fluids (edema) caused by heart failure or certain||
2098|019|U|medications. Acetazolamide can work less well over time, so it is||
2098|020|U|usually used only for a short period.||
2098|021|U|   It has also been used with other medications to treat certain||
2098|022|U|types of seizures (petit mal and unlocalized seizures).||
2098|023|B|||
2098|024|V|OTHER USES:  This section contains uses of this drug that are not||
2098|025|V|listed in the approved professional labeling for the drug but||
2098|026|V|that may be prescribed by your health care professional. Use this||
2098|027|V|drug for a condition that is listed in this section only if it||
2098|028|V|has been so prescribed by your health care professional.||
2098|029|V|   This drug may also be used for a certain condition causing a||
2098|030|V|serious increase in pressure inside the skull (intracranial||
2098|031|V|hypertension).||
2098|032|B|||
2098|033|H|HOW TO USE:  This medication is given by injection into a vein by||
2098|034|H|a health care professional. It is given as directed by your||
2098|035|H|doctor, usually 1 to 4 times daily.||
2098|036|H|   If you use this drug too close to bedtime, you may need to||
2098|037|H|wake up to urinate. It is best to use this medication at least 4||
2098|038|H|hours before your bedtime.||
2098|039|H|   The dosage is based on your medical condition and response to||
2098|040|H|treatment.||
2098|041|H|   Drink plenty of fluids unless otherwise directed by your||
2098|042|H|doctor.||
2098|043|H|   Use this medication regularly to get the most benefit from it.||
2098|044|H|To help you remember, use it at the same time(s) each day.||
2098|045|H|   Do not increase your dose or use this drug more often or for||
2098|046|H|longer than prescribed. Your condition will not improve any||
2098|047|H|faster, and your risk of side effects will increase.||
2098|048|H|   Tell your doctor if your condition lasts or gets worse.||
2098|049|B|||
2098|050|S|SIDE EFFECTS:  Dizziness, lightheadedness, or increased urination||
2098|051|S|may occur, especially during the first few days as your body||
2098|052|S|adjusts to the medication. Blurred vision, dry mouth, drowsiness,||
2098|053|S|loss of appetite, nausea, vomiting, diarrhea, or changes in taste||
2098|054|S|may also occur. If any of these effects last or get worse, tell||
2098|055|S|your doctor or pharmacist promptly.||
2098|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
2098|057|S|slowly when rising from a sitting or lying position.||
2098|058|S|   Remember that this medication has been prescribed because your||
2098|059|S|doctor has judged that the benefit to you is greater than the||
2098|060|S|risk of side effects. Many people using this medication do not||
2098|061|S|have serious side effects.||
2098|062|S|   Tell your doctor right away if you have any serious side||
2098|063|S|effects, including: tingling of the hands/feet, hearing loss,||
2098|064|S|ringing in the ears, unusual tiredness, easy bleeding/bruising,||
2098|065|S|fast/irregular heartbeat, muscle cramps/pain, new or worsening||
2098|066|S|eye pain, decrease in vision, mental/mood changes (such as||
2098|067|S|confusion, difficulty concentrating), signs of liver disease||
2098|068|S|(such as nausea/vomiting that doesn't stop, stomach/abdominal||
2098|069|S|pain, yellowing eyes/skin, dark urine), signs of kidney problems||
2098|070|S|(such as painful urination, pink/bloody urine, change in the||
2098|071|S|amount of urine), signs of infection (such as sore throat that||
2098|072|S|doesn't go away, fever, chills).||
2098|073|S|   A very serious allergic reaction to this drug is rare.||
2098|074|S|However, get medical help right away if you notice any symptoms||
2098|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2098|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2098|077|S|breathing.||
2098|078|S|   This is not a complete list of possible side effects. If you||
2098|079|S|notice other effects not listed above, contact your doctor or||
2098|080|S|pharmacist.||
2098|081|S|   In the US -||
2098|082|S|   Call your doctor for medical advice about side effects. You||
2098|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2098|084|S|www.fda.gov/medwatch.||
2098|085|S|   In Canada - Call your doctor for medical advice about side||
2098|086|S|effects. You may report side effects to Health Canada at||
2098|087|S|1-866-234-2345.||
2098|088|B|||
2098|089|P|PRECAUTIONS:  Before using acetazolamide, tell your doctor or||
2098|090|P|pharmacist if you are allergic to it; or if you have any other||
2098|091|P|allergies. This product may contain inactive ingredients, which||
2098|092|P|can cause allergic reactions or other problems. Talk to your||
2098|093|P|pharmacist for more details.||
2098|094|P|   Before using this medication, tell your doctor or pharmacist||
2098|095|P|your medical history, especially of: adrenal gland problems (such||
2098|096|P|as Addison's disease), untreated mineral imbalance (such as low||
2098|097|P|sodium/potassium, hyperchloremic acidosis), dehydration, kidney||
2098|098|P|disease, liver disease, breathing problems (such as chronic||
2098|099|P|obstructive pulmonary disease-COPD, emphysema, lung infection),||
2098|100|P|diabetes, gout, overactive thyroid (hyperthyroidism).||
2098|101|P|   This drug may make you dizzy or drowsy or cause blurred||
2098|102|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
2098|103|P|or drowsy. Do not drive, use machinery, or do anything that needs||
2098|104|P|alertness or clear vision until you can do it safely. Limit||
2098|105|P|alcoholic beverages. Talk to your doctor if you are using||
2098|106|P|marijuana (cannabis).||
2098|107|P|   This drug may rarely make your blood sugar rise, which can||
2098|108|P|cause or worsen diabetes. Tell your doctor right away if you have||
2098|109|P|symptoms of high blood sugar such as increased thirst/urination.||
2098|110|P|   If you already have diabetes, check your blood sugar regularly||
2098|111|P|as directed and share the results with your doctor. This||
2098|112|P|medication may also lower your blood sugar. Symptoms of low blood||
2098|113|P|sugar include sudden sweating, shaking, fast heartbeat, hunger,||
2098|114|P|blurred vision, dizziness or tingling hands/feet. It is a good||
2098|115|P|habit to carry glucose tablets or gel to treat low blood sugar.||
2098|116|P|If you don't have these reliable forms of glucose, rapidly raise||
2098|117|P|your blood sugar by eating a quick source of sugar such as table||
2098|118|P|sugar, honey, or candy, or drink fruit juice or non-diet soda.||
2098|119|P|Tell your doctor right away about the reaction and the use of||
2098|120|P|this product. To help prevent low blood sugar, eat meals on a||
2098|121|P|regular schedule, and do not skip meals.||
2098|122|P|   This medication may make you more sensitive to the sun. Limit||
2098|123|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2098|124|P|sunscreen and wear protective clothing when outdoors. Tell your||
2098|125|P|doctor right away if you get sunburned or have skin||
2098|126|P|blisters/redness.||
2098|127|P|   Before having surgery, tell your doctor or dentist about all||
2098|128|P|the products you use (including prescription drugs,||
2098|129|P|nonprescription drugs, and herbal products).||
2098|130|P|   Older adults may be more sensitive to the side effects of this||
2098|131|P|drug, especially dizziness and lightheadedness.||
2098|132|P|   During pregnancy, this medication should be used only when||
2098|133|P|clearly needed. Discuss the risks and benefits with your doctor.||
2098|134|P|   This medication passes into breast milk, but is unlikely to||
2098|135|P|harm a nursing infant. Consult your doctor before breastfeeding.||
2098|136|B|||
2098|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2098|138|I|medications work or increase your risk for serious side effects.||
2098|139|I|This document does not contain all possible drug interactions.||
2098|140|I|Keep a list of all the products you use (including||
2098|141|I|prescription/nonprescription drugs and herbal products) and share||
2098|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
2098|143|I|the dosage of any medicines without your doctor's approval.||
2098|144|I|   Some products that may interact with this drug are: lithium,||
2098|145|I|memantine, methenamine, orlistat, certain drugs used to treat||
2098|146|I|seizures (topiramate, zonisamide).||
2098|147|I|   Check the labels on all your medicines because they may||
2098|148|I|contain aspirin or aspirin-like drugs (salicylates), which can||
2098|149|I|cause serious side effects if taken in large doses with this||
2098|150|I|medication. However, if your doctor has told you to take low-dose||
2098|151|I|aspirin to prevent heart attack or stroke (usually 81-162||
2098|152|I|milligrams a day), you should keep taking the aspirin unless your||
2098|153|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2098|154|I|details.||
2098|155|I|   Some products have ingredients that could worsen your||
2098|156|I|swelling. Tell your pharmacist what products you are using, and||
2098|157|I|ask how to use them safely (especially NSAIDs such as||
2098|158|I|ibuprofen/naproxen).||
2098|159|I|   This medication may interfere with certain lab tests, possibly||
2098|160|I|causing false test results. Make sure lab personnel and all your||
2098|161|I|doctors know you use this drug.||
2098|162|B|||
2098|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2098|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2098|165|O|poison control center right away. US residents can call||
2098|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2098|167|B|||
2098|168|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2098|169|N|potassium and sodium levels in the blood, liver function) may be||
2098|170|N|done while you are using this medication. Keep all medical and||
2098|171|N|lab appointments. Consult your doctor for more details.||
2098|172|B|||
2098|173|D|MISSED DOSE:  It is important to get each dose of this medication||
2098|174|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2098|175|D|right away for a new dosing schedule.||
2098|176|B|||
2098|177|R|STORAGE:  Not applicable. This medication is given in a hospital||
2098|178|R|or clinic and will not be stored at home.||
2098|179|B|||
2098|180|A|Information last revised September 2025.||
2098|181|A|Copyright(c) 2025 First Databank, Inc.||
2098|182|B|||
2099|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2099|002|Z|does NOT have all possible information about this product. This||
2099|003|Z|information does not assure that this product is safe, effective,||
2099|004|Z|or appropriate for you. This information is not individual||
2099|005|Z|medical advice and does not substitute for the advice of your||
2099|006|Z|health care professional. Always ask your health care||
2099|007|Z|professional for complete information about this product and your||
2099|008|Z|specific health needs.||
2099|009|B|||
2099|010|T|MENTHOL PATCH - TOPICAL||
2099|011|F|(MEN-thol)||
2099|012|B|||
2099|013|C|COMMON BRAND NAME(S): Icy Hot, Thritex||
2099|014|B|||
2099|015|U|USES:  This medication is used to treat minor aches and pains of||
2099|016|U|the muscles/joints (such as arthritis, backache, sprains).||
2099|017|U|Menthol works by causing the skin to feel cool and then warm.||
2099|018|U|These feelings on the skin distract you from feeling the||
2099|019|U|aches/pains deeper in your muscles and joints.||
2099|020|B|||
2099|021|H|HOW TO USE:  Use this medication on the skin only. Clean and dry||
2099|022|H|the affected area. Remove the backing from the patch and apply||
2099|023|H|the patch to the affected area. Do not apply the patch to skin||
2099|024|H|that is injured or irritated (such as skin that is cut, scraped,||
2099|025|H|sunburned, infected, or has a rash). Leave the patch on the||
2099|026|H|affected area for up to 12 hours. Use this medication as directed||
2099|027|H|by your doctor or follow all directions on the product package.||
2099|028|H|If you have any questions, talk to your doctor or pharmacist.||
2099|029|H|   Take the patch off before bathing and do not apply the patch||
2099|030|H|right after bathing. Do not bandage or wrap the area where the||
2099|031|H|patch is applied unless directed to do so by the doctor. Do not||
2099|032|H|apply heat (such as a heating pad) on the patch. Doing so may||
2099|033|H|increase the risk of side effects.||
2099|034|H|   Wash your hands well after handling the patch. Avoid getting||
2099|035|H|this medication in your eyes, nose, or mouth. If you do get the||
2099|036|H|medication in those areas, flush with plenty of water.||
2099|037|H|   After removing each patch, fold the used patch with the sticky||
2099|038|H|sides together, and throw away in the trash away from children||
2099|039|H|and pets.||
2099|040|H|   Tell your doctor if your condition lasts for more than 7 days,||
2099|041|H|or if it gets worse, or if it keeps returning. If you think you||
2099|042|H|may have a serious medical problem, get medical help right away.||
2099|043|B|||
2099|044|S|SIDE EFFECTS:  Redness, mild itching, or irritation at the||
2099|045|S|application site may occur. If any of these effects last or get||
2099|046|S|worse, tell your doctor or pharmacist promptly.||
2099|047|S|   If your doctor has directed you to use this medication,||
2099|048|S|remember that your doctor has judged that the benefit to you is||
2099|049|S|greater than the risk of side effects. Many people using this||
2099|050|S|medication do not have serious side effects.||
2099|051|S|   Stop using this medication and tell your doctor right away if||
2099|052|S|you have any serious side effects, including: blistering/swelling||
2099|053|S|at the application site, increased/unusual pain at the||
2099|054|S|application site.||
2099|055|S|   A very serious allergic reaction to this drug is rare.||
2099|056|S|However, get medical help right away if you notice any symptoms||
2099|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2099|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2099|059|S|breathing.||
2099|060|S|   This is not a complete list of possible side effects. If you||
2099|061|S|notice other effects not listed above, contact your doctor or||
2099|062|S|pharmacist.||
2099|063|S|   In the US -||
2099|064|S|   Call your doctor for medical advice about side effects. You||
2099|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2099|066|S|www.fda.gov/medwatch.||
2099|067|S|   In Canada - Call your doctor for medical advice about side||
2099|068|S|effects. You may report side effects to Health Canada at||
2099|069|S|1-866-234-2345.||
2099|070|B|||
2099|071|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2099|072|P|pharmacist if you are allergic to menthol; or if you have any||
2099|073|P|other allergies. This product may contain inactive ingredients,||
2099|074|P|which can cause allergic reactions or other problems. Talk to||
2099|075|P|your pharmacist for more details.||
2099|076|P|   Before using this medication, tell your doctor or pharmacist||
2099|077|P|your medical history.||
2099|078|P|   Before having surgery, tell your doctor or dentist about all||
2099|079|P|the products you use (including prescription drugs,||
2099|080|P|nonprescription drugs, and herbal products).||
2099|081|P|   If you are going to have an MRI test, tell testing personnel||
2099|082|P|if you are using this patch. Some patches may contain metals that||
2099|083|P|can cause serious burns during an MRI. Ask your doctor whether||
2099|084|P|you will need to remove your patch before the test and apply a||
2099|085|P|new patch afterward, and how to do so properly.||
2099|086|P|   During pregnancy, this medication should be used only when||
2099|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
2099|088|P|   It is unknown if this medication passes into breast milk.||
2099|089|P|Consult your doctor before breastfeeding.||
2099|090|B|||
2099|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2099|092|I|medications work or increase your risk for serious side effects.||
2099|093|I|This document does not contain all possible drug interactions.||
2099|094|I|Keep a list of all the products you use (including||
2099|095|I|prescription/nonprescription drugs and herbal products) and share||
2099|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
2099|097|I|the dosage of any medicines without your doctor's approval.||
2099|098|B|||
2099|099|O|OVERDOSE:  This medication patch may be harmful if chewed or||
2099|100|O|swallowed. If someone has overdosed, remove the patch if||
2099|101|O|possible. For serious symptoms such as passing out or trouble||
2099|102|O|breathing, call 911. Otherwise, call a poison control center||
2099|103|O|right away. US residents can call 1-800-222-1222. Canada||
2099|104|O|residents can call 1-844-764-7669.||
2099|105|B|||
2099|106|N|NOTES:  Keep all medical and lab appointments.||
2099|107|B|||
2099|108|D|MISSED DOSE:  If you are using this product on a regular schedule||
2099|109|D|and miss a dose, use it as soon as you remember. If it is near||
2099|110|D|the time of the next dose, skip the missed dose. Use your next||
2099|111|D|dose at the regular time. Do not double the dose to catch up.||
2099|112|B|||
2099|113|R|STORAGE:  Store at room temperature. Different brands of this||
2099|114|R|medication have different storage needs. Check the product||
2099|115|R|package for instructions on how to store your brand, or ask your||
2099|116|R|pharmacist. Keep all medications away from children and pets.||
2099|117|R|   Do not flush medications down the toilet or pour them into a||
2099|118|R|drain unless instructed to do so. Properly discard this product||
2099|119|R|when it is expired or no longer needed. (See also How to Use||
2099|120|R|section.) Consult your pharmacist or local waste disposal||
2099|121|R|company.||
2099|122|B|||
2099|123|A|Information last revised February 2025.||
2099|124|A|Copyright(c) 2025 First Databank, Inc.||
2099|125|B|||
2100|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2100|002|Z|does NOT have all possible information about this product. This||
2100|003|Z|information does not assure that this product is safe, effective,||
2100|004|Z|or appropriate for you. This information is not individual||
2100|005|Z|medical advice and does not substitute for the advice of your||
2100|006|Z|health care professional. Always ask your health care||
2100|007|Z|professional for complete information about this product and your||
2100|008|Z|specific health needs.||
2100|009|B|||
2100|010|T|BUPRENORPHINE - INJECTION||
2100|011|F|(BUE-pre-NOR-feen)||
2100|012|B|||
2100|013|C|COMMON BRAND NAME(S): Buprenex||
2100|014|B|||
2100|015|W|WARNING:  Buprenorphine has a risk for abuse and addiction, which||
2100|016|W|can lead to overdose and death. Buprenorphine may also cause||
2100|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
2100|018|W|your doctor should have you use the smallest dose of||
2100|019|W|buprenorphine that works, and use it for the shortest possible||
2100|020|W|time. See also How to Use section for more information about||
2100|021|W|addiction.||
2100|022|W|   Ask your doctor or pharmacist if you should have medication||
2100|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
2100|024|W|Teach your family or household members about the signs of an||
2100|025|W|opioid overdose and how to treat it.||
2100|026|W|   The risk for severe breathing problems is higher when you||
2100|027|W|start this medication and after a dose increase, or if you use||
2100|028|W|the wrong dose/strength. Using this medication with alcohol or||
2100|029|W|other drugs that can cause drowsiness or breathing problems may||
2100|030|W|cause very serious side effects, including death. Be sure you||
2100|031|W|know how to use buprenorphine and what other drugs you should||
2100|032|W|avoid using with it. See also Drug Interactions section. Get||
2100|033|W|medical help right away if any of these very serious side effects||
2100|034|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
2100|035|W|drowsiness/dizziness, difficulty waking up.||
2100|036|W|   Before using this medication, women of childbearing age should||
2100|037|W|talk with their doctor(s) about the risks and benefits. Tell your||
2100|038|W|doctor if you are pregnant or if you plan to become pregnant.||
2100|039|W|During pregnancy, this medication should be used only when||
2100|040|W|clearly needed. It may slightly increase the risk of birth||
2100|041|W|defects if used during the first two months of pregnancy. Also,||
2100|042|W|using it for a long time or in high doses near the expected||
2100|043|W|delivery date may harm the unborn baby. To lessen the risk, use||
2100|044|W|the smallest effective dose for the shortest possible time.||
2100|045|W|Babies born to mothers who use this drug for a long time may||
2100|046|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
2100|047|W|doctor right away if you notice any symptoms in your newborn baby||
2100|048|W|such as crying that doesn't stop, slow/shallow breathing,||
2100|049|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
2100|050|W|difficulty gaining weight.||
2100|051|B|||
2100|052|U|USES:  Buprenorphine is used to help relieve moderate to severe||
2100|053|U|pain. Buprenorphine belongs to a class of drugs known as opioid||
2100|054|U|analgesics. It works in the brain to change how your body feels||
2100|055|U|and responds to pain.||
2100|056|B|||
2100|057|H|HOW TO USE:  This medication is given by injection into a vein or||
2100|058|H|muscle by a health care professional, as directed by your doctor.||
2100|059|H|   The dosage is based on your medical condition and response to||
2100|060|H|treatment.||
2100|061|H|   Pain medications work best if they are used as the first signs||
2100|062|H|of pain occur. If you wait until the pain has worsened, the||
2100|063|H|medication may not work as well.||
2100|064|H|   Suddenly stopping this medication may cause withdrawal,||
2100|065|H|especially if you have used it for a long time or in high doses.||
2100|066|H|To prevent withdrawal, your doctor may lower your dose slowly.||
2100|067|H|Tell your doctor or pharmacist right away if you have any||
2100|068|H|withdrawal symptoms such as restlessness, mental/mood changes||
2100|069|H|(including anxiety, trouble sleeping, thoughts of suicide),||
2100|070|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
2100|071|H|aches, or sudden changes in behavior.||
2100|072|H|   When this medication is used for a long time, it may not work||
2100|073|H|as well. Talk with your doctor if this medication stops working||
2100|074|H|well.||
2100|075|H|   Though it helps many people, this medication may sometimes||
2100|076|H|cause addiction. This risk may be higher if you have a||
2100|077|H|mental/mood disorder or a substance use disorder (such as overuse||
2100|078|H|of or addiction to drugs/alcohol). Use this medication exactly as||
2100|079|H|prescribed to lower the risk of addiction. Ask your doctor or||
2100|080|H|pharmacist for more details.||
2100|081|H|   Tell your doctor if your pain does not get better or if it||
2100|082|H|gets worse, or if you have any new pain.||
2100|083|B|||
2100|084|S|SIDE EFFECTS:  See also Warning section.||
2100|085|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
2100|086|S|drowsiness, headache, or sweating may occur. Some of these side||
2100|087|S|effects may decrease after you have been using this medication||
2100|088|S|for a while. Redness, itching, or irritation at the injection||
2100|089|S|site may also occur. If any of these effects last or get worse,||
2100|090|S|tell your doctor or pharmacist promptly.||
2100|091|S|   To prevent constipation, eat dietary fiber, drink enough||
2100|092|S|water, and exercise. You may also need to take a laxative. Ask||
2100|093|S|your pharmacist which type of laxative is right for you.||
2100|094|S|   To reduce the risk of dizziness and lightheadedness, get up||
2100|095|S|slowly when rising from a sitting or lying position.||
2100|096|S|   Remember that this medication has been prescribed because your||
2100|097|S|doctor has judged that the benefit to you is greater than the||
2100|098|S|risk of side effects. Many people using this medication do not||
2100|099|S|have serious side effects.||
2100|100|S|   Tell your doctor right away if you have any serious side||
2100|101|S|effects, including: interrupted breathing during sleep (sleep||
2100|102|S|apnea), mental/mood changes (such as agitation, confusion,||
2100|103|S|hallucinations), difficulty urinating, signs of your adrenal||
2100|104|S|glands not working well (such as loss of appetite, unusual||
2100|105|S|tiredness, weight loss), trouble swallowing.||
2100|106|S|   Get medical help right away if you have any very serious side||
2100|107|S|effects, including: fainting, seizure, slow/shallow breathing,||
2100|108|S|severe drowsiness/difficulty waking up, fast/irregular heartbeat,||
2100|109|S|severe dizziness.||
2100|110|S|   Buprenorphine may rarely cause serious (possibly fatal) liver||
2100|111|S|disease. Get medical help right away if you have any symptoms of||
2100|112|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
2100|113|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2100|114|S|urine.||
2100|115|S|   A very serious allergic reaction to this drug is rare.||
2100|116|S|However, get medical help right away if you notice any symptoms||
2100|117|S|of a serious allergic reaction, including: rash, itching/swelling||
2100|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2100|119|S|breathing.||
2100|120|S|   This is not a complete list of possible side effects. If you||
2100|121|S|notice other effects not listed above, contact your doctor or||
2100|122|S|pharmacist.||
2100|123|S|   In the US -||
2100|124|S|   Call your doctor for medical advice about side effects. You||
2100|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2100|126|S|www.fda.gov/medwatch.||
2100|127|S|   In Canada - Call your doctor for medical advice about side||
2100|128|S|effects. You may report side effects to Health Canada at||
2100|129|S|1-866-234-2345.||
2100|130|B|||
2100|131|P|PRECAUTIONS:  Before using buprenorphine, tell your doctor or||
2100|132|P|pharmacist if you are allergic to it; or if you have any other||
2100|133|P|allergies. This product may contain inactive ingredients, which||
2100|134|P|can cause allergic reactions or other problems. Talk to your||
2100|135|P|pharmacist for more details.||
2100|136|P|   Before using this medication, tell your doctor or pharmacist||
2100|137|P|your medical history, especially of: brain disorders (such as||
2100|138|P|head injury, tumor, seizures), breathing problems (such as||
2100|139|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
2100|140|P|gallbladder disease, kidney disease, liver disease, mental/mood||
2100|141|P|disorders (such as confusion, depression, thoughts of suicide),||
2100|142|P|personal or family history of a substance use disorder (such as||
2100|143|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
2100|144|P|problems (such as blockage, constipation, diarrhea due to||
2100|145|P|infection, paralytic ileus), disease of the pancreas||
2100|146|P|(pancreatitis), difficulty urinating (such as due to enlarged||
2100|147|P|prostate).||
2100|148|P|   Buprenorphine may cause a condition that affects the heart||
2100|149|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2100|150|P|serious (rarely fatal) fast/irregular heartbeat and other||
2100|151|P|symptoms (such as severe dizziness, fainting) that need medical||
2100|152|P|attention right away.||
2100|153|P|   The risk of QT prolongation may be increased if you have||
2100|154|P|certain medical conditions or are taking other drugs that may||
2100|155|P|cause QT prolongation. Before using buprenorphine, tell your||
2100|156|P|doctor or pharmacist of all the drugs you take and if you have||
2100|157|P|any of the following conditions: certain heart problems (heart||
2100|158|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2100|159|P|history of certain heart problems (QT prolongation in the EKG,||
2100|160|P|sudden cardiac death).||
2100|161|P|   Low levels of potassium or magnesium in the blood may also||
2100|162|P|increase your risk of QT prolongation. This risk may increase if||
2100|163|P|you use certain drugs (such as diuretics/"water pills") or if you||
2100|164|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2100|165|P|Talk to your doctor about using buprenorphine safely.||
2100|166|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2100|167|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2100|168|P|machinery, or do anything that needs alertness until you can do||
2100|169|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2100|170|P|are using marijuana (cannabis).||
2100|171|P|   Before having surgery, tell your doctor or dentist about all||
2100|172|P|the products you use (including prescription drugs,||
2100|173|P|nonprescription drugs, and herbal products).||
2100|174|P|   Older adults may be more sensitive to the side effects of this||
2100|175|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
2100|176|P|breathing, QT prolongation (see above).||
2100|177|P|   During pregnancy, this medication should be used only when||
2100|178|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2100|179|P|benefits with your doctor. (See also Warning section.)||
2100|180|P|   This drug passes into breast milk and may have undesirable||
2100|181|P|effects on a nursing infant. Tell the doctor right away if your||
2100|182|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
2100|183|P|breathing. Consult your doctor before breastfeeding.||
2100|184|B|||
2100|185|I|DRUG INTERACTIONS:  See also Warning section.||
2100|186|I|   Drug interactions may change how your medications work or||
2100|187|I|increase your risk for serious side effects. This document does||
2100|188|I|not contain all possible drug interactions. Keep a list of all||
2100|189|I|the products you use (including prescription/nonprescription||
2100|190|I|drugs and herbal products) and share it with your doctor and||
2100|191|I|pharmacist. Do not start, stop, or change the dosage of any||
2100|192|I|medicines without your doctor's approval.||
2100|193|I|   Some products that may interact with this drug are: certain||
2100|194|I|pain medications (mixed opioid agonist-antagonists such as||
2100|195|I|butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.||
2100|196|I|   The risk of serious side effects (such as slow/shallow||
2100|197|I|breathing, severe drowsiness/dizziness) may be increased if this||
2100|198|I|medication is used with other products that may also cause||
2100|199|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2100|200|I|if you are using other products such as other opioid pain or||
2100|201|I|cough relievers (such as codeine, hydrocodone), alcohol,||
2100|202|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
2100|203|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2100|204|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2100|205|I|cetirizine, diphenhydramine).||
2100|206|I|   Check the labels on all your medicines (such as allergy or||
2100|207|I|cough-and-cold products) because they may contain ingredients||
2100|208|I|that cause drowsiness.||
2100|209|I|   This medication may interfere with certain lab tests (such as||
2100|210|I|amylase/lipase levels), possibly causing false test results. Make||
2100|211|I|sure lab personnel and all your doctors know you use this drug.||
2100|212|B|||
2100|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2100|214|O|as passing out or trouble breathing, give them naloxone or||
2100|215|O|nalmefene if available, then call 911. If the person is awake and||
2100|216|O|has no symptoms, call a poison control center right away. US||
2100|217|O|residents can call 1-800-222-1222. Canada residents can call||
2100|218|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
2100|219|O|breathing, slow heartbeat, coma.||
2100|220|B|||
2100|221|N|NOTES:  Do not share this medication with others. Sharing it is||
2100|222|N|against the law.||
2100|223|B|||
2100|224|D|MISSED DOSE:  Not applicable.||
2100|225|B|||
2100|226|R|STORAGE:  Not applicable. This medication is given in a hospital||
2100|227|R|or clinic or doctor's office and will not be stored at home.||
2100|228|B|||
2100|229|A|Information last revised August 2025.||
2100|230|A|Copyright(c) 2025 First Databank, Inc.||
2100|231|B|||
2101|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2101|002|Z|does NOT have all possible information about this product. This||
2101|003|Z|information does not assure that this product is safe, effective,||
2101|004|Z|or appropriate for you. This information is not individual||
2101|005|Z|medical advice and does not substitute for the advice of your||
2101|006|Z|health care professional. Always ask your health care||
2101|007|Z|professional for complete information about this product and your||
2101|008|Z|specific health needs.||
2101|009|B|||
2101|010|T|MENTHOL - TOPICAL||
2101|011|F|(MEN-thol)||
2101|012|B|||
2101|013|C|COMMON BRAND NAME(S): BenGay, Berri-Freez, Biofreeze, Icy Hot||
2101|014|B|||
2101|015|U|USES:  Different brands of this product have different uses. Some||
2101|016|U|brands are used to treat minor aches and pains of the||
2101|017|U|muscles/joints (such as arthritis, backache, sprains). Some||
2101|018|U|brands are used to help relieve itching and skin irritation (such||
2101|019|U|as due to sunburn, insect bites, or minor scrapes). Menthol is||
2101|020|U|known as a counterirritant. It works by causing the skin to feel||
2101|021|U|cool and then warm.||
2101|022|B|||
2101|023|H|HOW TO USE:  If you are using the over-the-counter product to||
2101|024|H|self-treat, read and follow all directions on the product package||
2101|025|H|before using this medication. If you have any questions, consult||
2101|026|H|your pharmacist. If your doctor has prescribed this medication,||
2101|027|H|use it as directed.||
2101|028|H|   This medication is for use on the skin only. Apply to the||
2101|029|H|affected area no more than 3 to 4 times a day. If you are using||
2101|030|H|the cream, gel, or liquid, rub in gently and thoroughly. Some||
2101|031|H|liquid forms of this medication should be shaken before use.||
2101|032|H|Check the manufacturer's information for specific directions. Let||
2101|033|H|the medicine dry completely before letting anyone else touch the||
2101|034|H|area.||
2101|035|H|   Wash your hands well after applying unless you are using this||
2101|036|H|medication to treat the hands. Avoid getting this medication in||
2101|037|H|your eyes, nose, or mouth. If you do get the medication in those||
2101|038|H|areas, flush with plenty of water.||
2101|039|H|   Do not apply to serious burns or deep wounds. Do not bandage||
2101|040|H|or tightly wrap the affected area. Doing so may increase the risk||
2101|041|H|of side effects. You may cover the area loosely to protect||
2101|042|H|clothing.||
2101|043|H|   Heat can increase the risk of side effects. Do not apply this||
2101|044|H|medication right before, during, or after activities that||
2101|045|H|increase skin temperature (such as bathing, swimming, heavy||
2101|046|H|exercise). Wait until your skin has cooled before applying the||
2101|047|H|medication. Do not use a sunlamp/tanning bed, hot water bottle,||
2101|048|H|or heating pad/device on the treated area.||
2101|049|H|   Check the ingredients on the label even if you have used the||
2101|050|H|product before. The manufacturer may have changed the||
2101|051|H|ingredients. Also, products with similar names may contain||
2101|052|H|different ingredients meant for different purposes. Read the||
2101|053|H|label carefully to make sure you have the right product for you.||
2101|054|H|Ask your pharmacist if you have any questions.||
2101|055|H|   Tell your doctor if your condition lasts for more than 7 days,||
2101|056|H|or if it gets worse, or if it keeps returning. If you think you||
2101|057|H|may have a serious medical problem, get medical help right away.||
2101|058|B|||
2101|059|S|SIDE EFFECTS:  Redness, warmth, or irritation at the application||
2101|060|S|site may occur. If any of these effects last or get worse, tell||
2101|061|S|your doctor or pharmacist promptly.||
2101|062|S|   If your doctor has directed you to use this medication,||
2101|063|S|remember that your doctor has judged that the benefit to you is||
2101|064|S|greater than the risk of side effects. Many people using this||
2101|065|S|medication do not have serious side effects.||
2101|066|S|   Stop using this medication and tell your doctor right away if||
2101|067|S|you have any serious side effects, including: blistering/swelling||
2101|068|S|at the application site, increased/unusual pain at the||
2101|069|S|application site.||
2101|070|S|   A very serious allergic reaction to this drug is rare.||
2101|071|S|However, get medical help right away if you notice any symptoms||
2101|072|S|of a serious allergic reaction, including: rash, itching/swelling||
2101|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2101|074|S|breathing.||
2101|075|S|   This is not a complete list of possible side effects. If you||
2101|076|S|notice other effects not listed above, contact your doctor or||
2101|077|S|pharmacist.||
2101|078|S|   In the US -||
2101|079|S|   Call your doctor for medical advice about side effects. You||
2101|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2101|081|S|www.fda.gov/medwatch.||
2101|082|S|   In Canada - Call your doctor for medical advice about side||
2101|083|S|effects. You may report side effects to Health Canada at||
2101|084|S|1-866-234-2345.||
2101|085|B|||
2101|086|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2101|087|P|pharmacist if you are allergic to menthol; or if you have any||
2101|088|P|other allergies. This product may contain inactive ingredients,||
2101|089|P|which can cause allergic reactions or other problems. Talk to||
2101|090|P|your pharmacist for more details.||
2101|091|P|   Before using this medication, tell your doctor or pharmacist||
2101|092|P|your medical history.||
2101|093|P|   Before having surgery, tell your doctor or dentist about all||
2101|094|P|the products you use (including prescription drugs,||
2101|095|P|nonprescription drugs, and herbal products).||
2101|096|P|   During pregnancy, this medication should be used only when||
2101|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
2101|098|P|   It is unknown if this medication passes into breast milk.||
2101|099|P|Consult your doctor before breastfeeding.||
2101|100|B|||
2101|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2101|102|I|medications work or increase your risk for serious side effects.||
2101|103|I|This document does not contain all possible drug interactions.||
2101|104|I|Keep a list of all the products you use (including||
2101|105|I|prescription/nonprescription drugs and herbal products) and share||
2101|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
2101|107|I|the dosage of any medicines without your doctor's approval.||
2101|108|B|||
2101|109|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2101|110|O|has overdosed and has serious symptoms such as passing out or||
2101|111|O|trouble breathing, call 911. Otherwise, call a poison control||
2101|112|O|center right away. US residents can call 1-800-222-1222. Canada||
2101|113|O|residents can call 1-844-764-7669.||
2101|114|B|||
2101|115|N|NOTES:  Keep all medical and lab appointments.||
2101|116|B|||
2101|117|D|MISSED DOSE:  If you are using this product on a regular schedule||
2101|118|D|and miss a dose, use it as soon as you remember. If it is near||
2101|119|D|the time of the next dose, skip the missed dose. Use your next||
2101|120|D|dose at the regular time. Do not double the dose to catch up.||
2101|121|B|||
2101|122|R|STORAGE:  Store at room temperature. Different brands of this||
2101|123|R|medication have different storage needs. Check the product||
2101|124|R|package for instructions on how to store your brand, or ask your||
2101|125|R|pharmacist. Keep all medications away from children and pets.||
2101|126|R|   Do not flush medications down the toilet or pour them into a||
2101|127|R|drain unless instructed to do so. Properly discard this product||
2101|128|R|when it is expired or no longer needed. Consult your pharmacist||
2101|129|R|or local waste disposal company.||
2101|130|B|||
2101|131|A|Information last revised February 2025.||
2101|132|A|Copyright(c) 2025 First Databank, Inc.||
2101|133|B|||
2102|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2102|002|Z|does NOT have all possible information about this product. This||
2102|003|Z|information does not assure that this product is safe, effective,||
2102|004|Z|or appropriate for you. This information is not individual||
2102|005|Z|medical advice and does not substitute for the advice of your||
2102|006|Z|health care professional. Always ask your health care||
2102|007|Z|professional for complete information about this product and your||
2102|008|Z|specific health needs.||
2102|009|B|||
2102|010|T|GLUCAGON - SUBCUTANEOUS INJECTION||
2102|011|F|(GLOO-ka-gon)||
2102|012|B|||
2102|013|C|COMMON BRAND NAME(S): Gvoke||
2102|014|B|||
2102|015|U|USES:  This medication is the same as your body's own glucagon, a||
2102|016|U|natural substance that raises blood sugar by causing the body to||
2102|017|U|release sugar stored in the liver. It is used to treat very low||
2102|018|U|blood sugar (hypoglycemia) that may cause you to need help from||
2102|019|U|others. Make sure a family member or caregiver knows where you||
2102|020|U|keep this medication and how to use it before you need help.||
2102|021|B|||
2102|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
2102|023|H|Instructions for Use Leaflet provided by your pharmacist when you||
2102|024|H|get this medication and each time you get a refill. If you have||
2102|025|H|any questions, ask your doctor or pharmacist.||
2102|026|H|   An episode of very low blood sugar should be treated right||
2102|027|H|away to prevent serious effects (such as brain damage). Be sure||
2102|028|H|to keep this medication handy in case it is needed. You and your||
2102|029|H|caregiver must learn ahead of time how to properly give this||
2102|030|H|medication. Each autoinjector/syringe can be used only one time.||
2102|031|H|Caregivers should also know the symptoms of low blood sugar (see||
2102|032|H|also Precautions section).||
2102|033|H|   Remove the autoinjector/syringe from the package only when you||
2102|034|H|are ready to use it. Before using, check this product for||
2102|035|H|particles or discoloration. If either is present, do not use the||
2102|036|H|liquid. Learn how to store and discard medical supplies safely.||
2102|037|H|   Inject this medication under the skin as directed by your||
2102|038|H|doctor. Do not inject through clothing. The injection is given in||
2102|039|H|the abdomen, thigh, or upper arm. The dosage is based on your||
2102|040|H|age. Children's dosage is also based on weight. After giving this||
2102|041|H|medication, get medical help right away.||
2102|042|H|   If the person is unconscious, turn the person on their side to||
2102|043|H|prevent choking in case they vomit. If the person does not wake||
2102|044|H|up after 15 minutes, another dose may be given, if available.||
2102|045|H|   When the person wakes up and is able to swallow, a quick sugar||
2102|046|H|source (such as glucose tablets, juice) should be given. Glucagon||
2102|047|H|is only effective for a short time, and low blood sugar may||
2102|048|H|return. The blood sugar level should be kept up by eating snacks||
2102|049|H|such as crackers, cheese, a meat sandwich, or milk.||
2102|050|H|   Always call your doctor right away when an episode of very low||
2102|051|H|blood sugar has happened. You may need more medical treatment, or||
2102|052|H|your insulin dose and diet may need to be adjusted.||
2102|053|B|||
2102|054|S|SIDE EFFECTS:  Nausea, vomiting, or headache may occur.||
2102|055|S|Irritation, redness, or swelling at the injection site may also||
2102|056|S|occur. If any of these effects last or get worse, tell your||
2102|057|S|doctor or pharmacist promptly.||
2102|058|S|   Remember that this medication has been prescribed because your||
2102|059|S|doctor has judged that the benefit to you is greater than the||
2102|060|S|risk of side effects. Many people using this medication do not||
2102|061|S|have serious side effects.||
2102|062|S|   Tell your doctor right away if you have any serious side||
2102|063|S|effects, including: fast/pounding heartbeat.||
2102|064|S|   A very serious allergic reaction to this drug is rare.||
2102|065|S|However, get medical help right away if you notice any symptoms||
2102|066|S|of a serious allergic reaction, including: rash, itching/swelling||
2102|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2102|068|S|breathing.||
2102|069|S|   This is not a complete list of possible side effects. If you||
2102|070|S|notice other effects not listed above, contact your doctor or||
2102|071|S|pharmacist.||
2102|072|S|   In the US -||
2102|073|S|   Call your doctor for medical advice about side effects. You||
2102|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2102|075|S|www.fda.gov/medwatch.||
2102|076|S|   In Canada - Call your doctor for medical advice about side||
2102|077|S|effects. You may report side effects to Health Canada at||
2102|078|S|1-866-234-2345.||
2102|079|B|||
2102|080|P|PRECAUTIONS:  Before using glucagon, tell your doctor or||
2102|081|P|pharmacist if you are allergic to it; or if you have any other||
2102|082|P|allergies. This product may contain inactive ingredients, which||
2102|083|P|can cause allergic reactions or other problems. Talk to your||
2102|084|P|pharmacist for more details.||
2102|085|P|   Before using this medication, tell your doctor or pharmacist||
2102|086|P|your medical history, especially of: tumor of the pancreas||
2102|087|P|(insulinoma), adrenal gland problem (such as Addison's disease,||
2102|088|P|pheochromocytoma), not eating/poor eating habits, frequent low||
2102|089|P|blood sugar.||
2102|090|P|   Low blood sugar (hypoglycemia) is more likely if you do not||
2102|091|P|consume enough calories from food, or if you do unusually heavy||
2102|092|P|exercise. Symptoms include sudden sweating, shaking, fast||
2102|093|P|heartbeat, hunger, blurred vision, dizziness, or tingling||
2102|094|P|hands/feet. It is a good habit to carry glucose tablets or gel to||
2102|095|P|treat low blood sugar. If you don't have these reliable forms of||
2102|096|P|glucose, rapidly raise your blood sugar by eating a quick source||
2102|097|P|of sugar such as table sugar, honey, or candy, or drink fruit||
2102|098|P|juice or non-diet soda. Tell your doctor right away about the||
2102|099|P|reaction and the use of this product. To help prevent low blood||
2102|100|P|sugar, eat meals on a regular schedule, and do not skip meals.||
2102|101|P|Check with your doctor or pharmacist to find out what you should||
2102|102|P|do if you miss a meal.||
2102|103|P|   Tell your doctor if you are pregnant before using this||
2102|104|P|medication.||
2102|105|P|   It is unknown if this drug passes into breast milk, but it is||
2102|106|P|unlikely to harm a nursing infant. Consult your doctor before||
2102|107|P|breastfeeding.||
2102|108|B|||
2102|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2102|110|I|medications work or increase your risk for serious side effects.||
2102|111|I|This document does not contain all possible drug interactions.||
2102|112|I|Keep a list of all the products you use (including||
2102|113|I|prescription/nonprescription drugs and herbal products) and share||
2102|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
2102|115|I|the dosage of any medicines without your doctor's approval.||
2102|116|B|||
2102|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2102|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2102|119|O|poison control center right away. US residents can call||
2102|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2102|121|B|||
2102|122|N|NOTES:  Do not share this medication with others.||
2102|123|N|   Attend a diabetes education program to learn more about how to||
2102|124|N|manage your diabetes with medications, diet, exercise, and||
2102|125|N|regular medical exams.||
2102|126|N|   Learn the symptoms of high and low blood sugar and how to||
2102|127|N|treat low blood sugar. Check your blood sugar regularly as||
2102|128|N|directed.||
2102|129|B|||
2102|130|D|MISSED DOSE:  Not applicable.||
2102|131|B|||
2102|132|R|STORAGE:  Store at room temperature. Do not refrigerate or||
2102|133|R|freeze. Keep the medication in the original packaging to protect||
2102|134|R|from light. Keep all medications away from children and pets.||
2102|135|R|   Do not flush medications down the toilet or pour them into a||
2102|136|R|drain unless instructed to do so. Properly discard this product||
2102|137|R|when it is expired or no longer needed. Consult your pharmacist||
2102|138|R|or local waste disposal company.||
2102|139|B|||
2102|140|M|MEDICAL ALERT:  Your condition can cause complications in a||
2102|141|M|medical emergency. For information about enrolling in MedicAlert,||
2102|142|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2102|143|B|||
2102|144|A|Information last revised December 2024.||
2102|145|A|Copyright(c) 2025 First Databank, Inc.||
2102|146|B|||
2103|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2103|002|Z|does NOT have all possible information about this product. This||
2103|003|Z|information does not assure that this product is safe, effective,||
2103|004|Z|or appropriate for you. This information is not individual||
2103|005|Z|medical advice and does not substitute for the advice of your||
2103|006|Z|health care professional. Always ask your health care||
2103|007|Z|professional for complete information about this product and your||
2103|008|Z|specific health needs.||
2103|009|B|||
2103|010|T|MIDAZOLAM SPRAY - NASAL||
2103|011|F|(mi-DAZ-oh-lam)||
2103|012|B|||
2103|013|C|COMMON BRAND NAME(S): Nayzilam||
2103|014|B|||
2103|015|W|WARNING:  Midazolam has a risk for abuse and addiction, which can||
2103|016|W|lead to overdose and death. Using this medication with alcohol or||
2103|017|W|other drugs that can cause drowsiness or breathing problems||
2103|018|W|(especially opioid medications such as codeine, hydrocodone) may||
2103|019|W|cause very serious side effects, including death. To lower your||
2103|020|W|risk, your doctor should have you use the smallest dose of||
2103|021|W|midazolam that works, and use it for the shortest possible time.||
2103|022|W|Be sure you know how to use midazolam and what other drugs you||
2103|023|W|should avoid taking with it. See also Drug Interactions section.||
2103|024|W|Get medical help right away if any of these very serious side||
2103|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
2103|026|W|severe drowsiness/dizziness, difficulty waking up.||
2103|027|W|   This medication should not be used regularly. If you use it||
2103|028|W|regularly, suddenly stopping this medication may cause serious||
2103|029|W|(possibly fatal) withdrawal, especially if you have used it for a||
2103|030|W|long time or in high doses. To prevent withdrawal, your doctor||
2103|031|W|may lower your dose slowly. Tell your doctor or pharmacist right||
2103|032|W|away if you have any withdrawal symptoms such as headaches,||
2103|033|W|trouble sleeping, restlessness, hallucinations/confusion,||
2103|034|W|depression, nausea, or seizures. Withdrawal symptoms may||
2103|035|W|sometimes last weeks to months.||
2103|036|B|||
2103|037|U|USES:  This medication is used by people with epilepsy to treat a||
2103|038|U|certain type of serious seizure that doesn't stop (seizure||
2103|039|U|clusters). Midazolam belongs to a class of drugs known as||
2103|040|U|benzodiazepines. It may work by increasing the effect of a||
2103|041|U|certain substance in your body (GABA), which helps calm the brain||
2103|042|U|and nerves.||
2103|043|B|||
2103|044|H|HOW TO USE:  See also Warning section.||
2103|045|H|   Read the Medication Guide and Instructions for Use provided by||
2103|046|H|your pharmacist when you get this medication and each time you||
2103|047|H|get a refill. Be sure to keep this medication handy in case it is||
2103|048|H|needed. Learn ahead of time how to properly use this medication.||
2103|049|H|Each nasal spray device can be used only one time. If you have||
2103|050|H|any questions, ask your doctor or pharmacist.||
2103|051|H|   Caregivers should learn when this medication should be used||
2103|052|H|and what to watch for after using this medication. Make sure a||
2103|053|H|family member or caregiver knows where you keep this medication||
2103|054|H|and how to use it in case you need their help.||
2103|055|H|   This product is for use in the nose only. Remove the midazolam||
2103|056|H|spray from the package only when you are ready to use it. Do not||
2103|057|H|test or prime the spray before use. Doing so will make you lose||
2103|058|H|the dose. Gently insert the tip of the spray nozzle into one||
2103|059|H|nostril, then firmly press the plunger to give the dose. This||
2103|060|H|medication does not need to be inhaled to work. Throw away the||
2103|061|H|nasal spray device after using it.||
2103|062|H|   If the seizure cluster is continuing 10 minutes after giving||
2103|063|H|this medication, another dose may be given if available, and if||
2103|064|H|you have been told to do so by the doctor. If using a second||
2103|065|H|dose, give it in the opposite nostril. Do not use more than 2||
2103|066|H|doses to treat a seizure cluster episode. If the seizure cluster||
2103|067|H|is continuing after using this medication as directed, get||
2103|068|H|medical help right away.||
2103|069|H|   Do not use to treat episodes more often than once every 3||
2103|070|H|days, or more than 5 times in a month. Doing so may make this||
2103|071|H|medication stop working well. Your seizures may get worse or||
2103|072|H|happen more often. Talk with your doctor if this medication stops||
2103|073|H|working well.||
2103|074|H|   Though it helps many people, this medication may sometimes||
2103|075|H|cause addiction. This risk may be higher if you have a substance||
2103|076|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2103|077|H|Use this medication exactly as prescribed to lower the risk of||
2103|078|H|addiction. Ask your doctor or pharmacist for more details.||
2103|079|B|||
2103|080|S|SIDE EFFECTS:  See also Warning section.||
2103|081|S|   Drowsiness, dizziness, headache, or nasal discomfort may||
2103|082|S|occur. If any of these effects last or get worse, tell your||
2103|083|S|doctor or pharmacist promptly.||
2103|084|S|   Remember that this medication has been prescribed because your||
2103|085|S|doctor has judged that the benefit to you is greater than the||
2103|086|S|risk of side effects. Many people using this medication do not||
2103|087|S|have serious side effects.||
2103|088|S|   Tell your doctor right away if you have any serious side||
2103|089|S|effects, including: uncontrolled movements (such as||
2103|090|S|shaking/tremor).||
2103|091|S|   Get medical help right away if you have any very serious side||
2103|092|S|effects, including: slow/shallow breathing, unusual||
2103|093|S|drowsiness/difficulty waking up.||
2103|094|S|   A small number of people who take anticonvulsants for any||
2103|095|S|condition (such as seizure, bipolar disorder, pain) may||
2103|096|S|experience depression, suicidal thoughts/attempts, or other||
2103|097|S|mental/mood problems. Tell your doctor right away if you or your||
2103|098|S|family/caregiver notice any unusual/sudden changes in your mood,||
2103|099|S|thoughts, or behavior such as signs of depression, suicidal||
2103|100|S|thoughts/attempts, thoughts about harming yourself.||
2103|101|S|   A very serious allergic reaction to this drug is rare.||
2103|102|S|However, get medical help right away if you notice any symptoms||
2103|103|S|of a serious allergic reaction, including: rash, itching/swelling||
2103|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2103|105|S|breathing.||
2103|106|S|   This is not a complete list of possible side effects. If you||
2103|107|S|notice other effects not listed above, contact your doctor or||
2103|108|S|pharmacist.||
2103|109|S|   In the US -||
2103|110|S|   Call your doctor for medical advice about side effects. You||
2103|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2103|112|S|www.fda.gov/medwatch.||
2103|113|S|   In Canada - Call your doctor for medical advice about side||
2103|114|S|effects. You may report side effects to Health Canada at||
2103|115|S|1-866-234-2345.||
2103|116|B|||
2103|117|P|PRECAUTIONS:  Before using midazolam, tell your doctor or||
2103|118|P|pharmacist if you are allergic to it; or to other benzodiazepines||
2103|119|P|(such as diazepam, lorazepam); or if you have any other||
2103|120|P|allergies. This product may contain inactive ingredients which||
2103|121|P|can cause allergic reactions or other problems. Talk to your||
2103|122|P|pharmacist for more details.||
2103|123|P|   Before using this medication, tell your doctor or pharmacist||
2103|124|P|your medical history, especially of: glaucoma, heart failure,||
2103|125|P|kidney disease, liver disease, breathing problems (such as||
2103|126|P|chronic obstructive lung disease-COPD, sleep apnea), personal or||
2103|127|P|family history of a substance use disorder (such as overuse of or||
2103|128|P|addiction to drugs/alcohol).||
2103|129|P|   This drug may make you dizzy, drowsy, or affect your memory.||
2103|130|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
2103|131|P|drowsy. Do not drive, use machinery, or do anything that needs||
2103|132|P|alertness until you can do it safely. Avoid alcoholic beverages.||
2103|133|P|Talk to your doctor if you are using marijuana (cannabis).||
2103|134|P|   Before having surgery, tell your doctor or dentist about all||
2103|135|P|the products you use (including prescription drugs,||
2103|136|P|nonprescription drugs, and herbal products).||
2103|137|P|   During pregnancy, this medication should be used only when||
2103|138|P|clearly needed. It may harm an unborn baby. Newborn babies of||
2103|139|P|mothers who use this medication late in pregnancy may have||
2103|140|P|symptoms such as slow/shallow breathing, nonstop crying, shaking,||
2103|141|P|or trouble feeding. However, since untreated seizures are a||
2103|142|P|serious condition that can harm both a pregnant woman and her||
2103|143|P|unborn baby, do not stop taking this medication unless directed||
2103|144|P|by your doctor. If you are planning pregnancy, become pregnant,||
2103|145|P|or think you may be pregnant, talk to your doctor right away||
2103|146|P|about the risks and benefits of this medication.||
2103|147|P|   This drug passes into breast milk. Consult your doctor before||
2103|148|P|breastfeeding.||
2103|149|B|||
2103|150|I|DRUG INTERACTIONS:  See also Warning section.||
2103|151|I|   Drug interactions may change how your medications work or||
2103|152|I|increase your risk for serious side effects. This document does||
2103|153|I|not contain all possible drug interactions. Keep a list of all||
2103|154|I|the products you use (including prescription/nonprescription||
2103|155|I|drugs and herbal products) and share it with your doctor and||
2103|156|I|pharmacist. Do not start, stop, or change the dosage of any||
2103|157|I|medicines without your doctor's approval.||
2103|158|I|   Some products that may interact with this drug are:||
2103|159|I|conivaptan, HIV protease inhibitors (such as atazanavir),||
2103|160|I|lonafarnib, ritonavir, sodium oxybate.||
2103|161|I|   The risk of serious side effects (such as slow/shallow||
2103|162|I|breathing, severe drowsiness/dizziness) may be increased if this||
2103|163|I|medication is used with other products that may also cause||
2103|164|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2103|165|I|if you are using other products such as opioid pain or cough||
2103|166|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2103|167|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2103|168|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2103|169|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2103|170|I|diphenhydramine).||
2103|171|I|   Check the labels on all your medicines (such as allergy or||
2103|172|I|cough-and-cold products) because they may contain ingredients||
2103|173|I|that cause drowsiness. Ask your pharmacist about using those||
2103|174|I|products safely.||
2103|175|B|||
2103|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2103|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2103|178|O|poison control center right away. US residents can call||
2103|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2103|180|O|Symptoms of overdose may include: confusion, slow/shallow||
2103|181|O|breathing, coma.||
2103|182|B|||
2103|183|N|NOTES:  Do not share this medication with others. Sharing it is||
2103|184|N|against the law.||
2103|185|B|||
2103|186|D|MISSED DOSE:  Not applicable.||
2103|187|B|||
2103|188|R|STORAGE:  Store at room temperature. Do not remove the nasal||
2103|189|R|spray from the package until you are ready to use it. Keep all||
2103|190|R|medications away from children and pets.||
2103|191|R|   Do not flush medications down the toilet or pour them into a||
2103|192|R|drain unless instructed to do so. Properly discard this product||
2103|193|R|when it is expired or no longer needed. Consult your pharmacist||
2103|194|R|or local waste disposal company.||
2103|195|B|||
2103|196|M|MEDICAL ALERT:  Your condition can cause complications in a||
2103|197|M|medical emergency. For information about enrolling in MedicAlert,||
2103|198|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2103|199|B|||
2103|200|A|Information last revised March 2025.||
2103|201|A|Copyright(c) 2025 First Databank, Inc.||
2103|202|B|||
2104|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2104|002|Z|does NOT have all possible information about this product. This||
2104|003|Z|information does not assure that this product is safe, effective,||
2104|004|Z|or appropriate for you. This information is not individual||
2104|005|Z|medical advice and does not substitute for the advice of your||
2104|006|Z|health care professional. Always ask your health care||
2104|007|Z|professional for complete information about this product and your||
2104|008|Z|specific health needs.||
2104|009|B|||
2104|010|T|MENTHOL LOZENGE - MUCOUS MEMBRANE (ORAL)||
2104|011|F|(MEN-thol)||
2104|012|B|||
2104|013|C|COMMON BRAND NAME(S): Halls, Ricola, Vicks VapoDrops||
2104|014|B|||
2104|015|U|USES:  This product is used to temporarily help relieve symptoms||
2104|016|U|such as sore throat, throat irritation, or cough (due to a cold,||
2104|017|U|for example). It works by providing a cooling feeling and||
2104|018|U|increasing saliva in the mouth.||
2104|019|U|   Check the ingredients on the label even if you have used the||
2104|020|U|product before. The manufacturer may have changed the||
2104|021|U|ingredients. Also, products with similar names may contain||
2104|022|U|different ingredients meant for different purposes.||
2104|023|B|||
2104|024|H|HOW TO USE:  Read and follow all directions on the product||
2104|025|H|package before using this medication. If you have any questions,||
2104|026|H|consult your pharmacist. If your doctor has directed you to use||
2104|027|H|this product, use it as directed.||
2104|028|H|   Let the lozenge dissolve slowly in your mouth and swallow the||
2104|029|H|dissolved liquid along with your saliva. Do not chew or swallow||
2104|030|H|it whole.||
2104|031|H|   This product is usually used every 2 hours as needed. If your||
2104|032|H|doctor has directed you to use it, follow your doctor's||
2104|033|H|instructions on how to use it. Do not increase your dose or use||
2104|034|H|this drug more often or for longer than directed.||
2104|035|H|   If you have a sore throat that is severe or that lasts more||
2104|036|H|than 2 days, or a cough that lasts more than 7 days or keeps||
2104|037|H|coming back, or symptoms occur with a fever, headache, rash,||
2104|038|H|swelling, nausea, or vomiting, tell your doctor promptly. If sore||
2104|039|H|mouth/throat or cough symptoms do not get better or last more||
2104|040|H|than 7 days, see your doctor or dentist promptly. These could be||
2104|041|H|signs of a serious condition. If you think you may have a serious||
2104|042|H|medical problem, get medical help right away.||
2104|043|B|||
2104|044|S|SIDE EFFECTS:  Numbness of the mouth or throat may occur. If this||
2104|045|S|effect lasts or gets worse, tell your doctor or pharmacist||
2104|046|S|promptly.||
2104|047|S|   If your doctor has directed you to use this medication,||
2104|048|S|remember that your doctor has judged that the benefit to you is||
2104|049|S|greater than the risk of side effects. Many people using this||
2104|050|S|medication do not have serious side effects.||
2104|051|S|   A very serious allergic reaction to this drug is rare.||
2104|052|S|However, get medical help right away if you notice any symptoms||
2104|053|S|of a serious allergic reaction, including: rash, itching/swelling||
2104|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2104|055|S|breathing.||
2104|056|S|   This is not a complete list of possible side effects. If you||
2104|057|S|notice other effects not listed above, contact your doctor or||
2104|058|S|pharmacist.||
2104|059|S|   In the US -||
2104|060|S|   Call your doctor for medical advice about side effects. You||
2104|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2104|062|S|www.fda.gov/medwatch.||
2104|063|S|   In Canada - Call your doctor for medical advice about side||
2104|064|S|effects. You may report side effects to Health Canada at||
2104|065|S|1-866-234-2345.||
2104|066|B|||
2104|067|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2104|068|P|pharmacist if you are allergic to menthol; or if you have any||
2104|069|P|other allergies. This product may contain inactive ingredients,||
2104|070|P|which can cause allergic reactions or other problems. Talk to||
2104|071|P|your pharmacist for more details.||
2104|072|P|   Before using this product, tell your doctor or pharmacist your||
2104|073|P|medical history, especially of: breathing problems (such as||
2104|074|P|asthma, emphysema), cough with a lot of mucus.||
2104|075|P|   This product may contain sugar and/or aspartame. Caution is||
2104|076|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
2104|077|P|condition that requires you to limit/avoid these substances in||
2104|078|P|your diet. Ask your doctor or pharmacist about using this product||
2104|079|P|safely.||
2104|080|P|   Before having surgery, tell your doctor or dentist about all||
2104|081|P|the products you use (including prescription drugs,||
2104|082|P|nonprescription drugs, and herbal products).||
2104|083|P|   Tell your doctor or pharmacist if you are pregnant before||
2104|084|P|using this product.||
2104|085|P|   Menthol passes into breast milk in small amounts. Consult your||
2104|086|P|doctor before breastfeeding.||
2104|087|B|||
2104|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2104|089|I|medications work or increase your risk for serious side effects.||
2104|090|I|This document does not contain all possible drug interactions.||
2104|091|I|Keep a list of all the products you use (including||
2104|092|I|prescription/nonprescription drugs and herbal products) and share||
2104|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
2104|094|I|the dosage of any medicines without your doctor's approval.||
2104|095|B|||
2104|096|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2104|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2104|098|O|poison control center right away. US residents can call||
2104|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2104|100|B|||
2104|101|N|NOTES:  Keep all medical and lab appointments.||
2104|102|B|||
2104|103|D|MISSED DOSE:  Not applicable.||
2104|104|B|||
2104|105|R|STORAGE:  Store at room temperature away from light and moisture.||
2104|106|R|Do not store in the bathroom. Keep all medications away from||
2104|107|R|children and pets.||
2104|108|R|   Do not flush medications down the toilet or pour them into a||
2104|109|R|drain unless instructed to do so. Properly discard this product||
2104|110|R|when it is expired or no longer needed. Consult your pharmacist||
2104|111|R|or local waste disposal company.||
2104|112|B|||
2104|113|A|Information last revised February 2025.||
2104|114|A|Copyright(c) 2025 First Databank, Inc.||
2104|115|B|||
2105|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2105|002|Z|does NOT have all possible information about this product. This||
2105|003|Z|information does not assure that this product is safe, effective,||
2105|004|Z|or appropriate for you. This information is not individual||
2105|005|Z|medical advice and does not substitute for the advice of your||
2105|006|Z|health care professional. Always ask your health care||
2105|007|Z|professional for complete information about this product and your||
2105|008|Z|specific health needs.||
2105|009|B|||
2105|010|T|BACLOFEN - INJECTION||
2105|011|F|(BAK-loe-fen)||
2105|012|B|||
2105|013|C|COMMON BRAND NAME(S): Lioresal||
2105|014|B|||
2105|015|W|WARNING:  Do not stop using this medication without consulting||
2105|016|W|your doctor. Serious (rarely fatal) withdrawal problems may occur||
2105|017|W|if this medication is suddenly stopped. Get medical help right||
2105|018|W|away if you have any signs of a withdrawal reaction, including:||
2105|019|W|itching, numb/tingling skin, high fever, mental/mood changes||
2105|020|W|(such as confusion), seizures, worsening muscle||
2105|021|W|tightness/stiffness, signs of kidney problems (such as change in||
2105|022|W|the amount of urine). Tell your doctor if you ever had a||
2105|023|W|withdrawal reaction from baclofen.||
2105|024|W|   Keep all appointments for refilling the pump to avoid any||
2105|025|W|serious withdrawal problems. Your doctor or another health care||
2105|026|W|professional will check that the pump is programmed and working||
2105|027|W|properly during these appointments. If you must miss a refill||
2105|028|W|appointment, contact your doctor right away to reschedule the||
2105|029|W|appointment before you run out of medication. Also, learn what||
2105|030|W|your pump alarm sounds like. If you hear the alarm, contact your||
2105|031|W|doctor right away.||
2105|032|B|||
2105|033|U|USES:  Baclofen is used to treat muscle spasms caused by certain||
2105|034|U|conditions (such as multiple sclerosis, cerebral palsy, spinal||
2105|035|U|cord injury/disease). It works by helping to relax the muscles.||
2105|036|U|   Baclofen injection is used by patients who do not respond to||
2105|037|U|or who cannot tolerate the side effects of baclofen taken by||
2105|038|U|mouth.||
2105|039|B|||
2105|040|H|HOW TO USE:  This medication is given by injection into the area||
2105|041|H|around the spinal cord (intrathecal). It is usually given using a||
2105|042|H|drug pump implanted under your skin. A health care professional||
2105|043|H|will fill and refill the pump with medication.||
2105|044|H|   The dosage is based on your medical condition and response to||
2105|045|H|treatment.||
2105|046|H|   If you are giving this medication to yourself at home, learn||
2105|047|H|all preparation and usage instructions from your health care||
2105|048|H|professional. Before using, check this product for particles or||
2105|049|H|discoloration. If either is present, do not use the liquid. Learn||
2105|050|H|how to store and discard medical supplies safely.||
2105|051|H|   Do not stop treatment with this drug without consulting your||
2105|052|H|doctor. If you suddenly stop using this medication, you may have||
2105|053|H|serious withdrawal symptoms. See also Warning section. To prevent||
2105|054|H|withdrawal, your doctor may lower your dose slowly. Consult your||
2105|055|H|doctor or pharmacist for more details, and report any withdrawal||
2105|056|H|reactions right away.||
2105|057|H|   When this medication is used for a long time, it may not work||
2105|058|H|as well. Talk with your doctor if this medication stops working||
2105|059|H|well.||
2105|060|H|   Tell your doctor if your condition does not get better or if||
2105|061|H|it gets worse, or if you have any signs of infection (such as||
2105|062|H|fever, chills, redness/swelling/pain/warmth at the pump site).||
2105|063|B|||
2105|064|S|SIDE EFFECTS:  Drowsiness, dizziness, weakness, headache,||
2105|065|S|constipation, nausea, or vomiting may occur. If any of these||
2105|066|S|effects last or get worse, tell your doctor or pharmacist||
2105|067|S|promptly.||
2105|068|S|   Remember that this medication has been prescribed because your||
2105|069|S|doctor has judged that the benefit to you is greater than the||
2105|070|S|risk of side effects. Many people using this medication do not||
2105|071|S|have serious side effects.||
2105|072|S|   Tell your doctor right away if you have any serious side||
2105|073|S|effects, including: mental/mood changes (such as confusion,||
2105|074|S|depression, hallucinations), numb/tingling skin, vision changes,||
2105|075|S|difficulty urinating.||
2105|076|S|   Get medical help right away if you have any very serious side||
2105|077|S|effects, including: seizures, trouble breathing.||
2105|078|S|   A very serious allergic reaction to this drug is rare.||
2105|079|S|However, get medical help right away if you notice any symptoms||
2105|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2105|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2105|082|S|breathing.||
2105|083|S|   This is not a complete list of possible side effects. If you||
2105|084|S|notice other effects not listed above, contact your doctor or||
2105|085|S|pharmacist.||
2105|086|S|   In the US -||
2105|087|S|   Call your doctor for medical advice about side effects. You||
2105|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2105|089|S|www.fda.gov/medwatch.||
2105|090|S|   In Canada - Call your doctor for medical advice about side||
2105|091|S|effects. You may report side effects to Health Canada at||
2105|092|S|1-866-234-2345.||
2105|093|B|||
2105|094|P|PRECAUTIONS:  Before using baclofen, tell your doctor or||
2105|095|P|pharmacist if you are allergic to it; or if you have any other||
2105|096|P|allergies. This product may contain inactive ingredients, which||
2105|097|P|can cause allergic reactions or other problems. Talk to your||
2105|098|P|pharmacist for more details.||
2105|099|P|   Before using this medication, tell your doctor or pharmacist||
2105|100|P|your medical history, especially of: recent/current infection,||
2105|101|P|seizures, mental/mood disorders (such as schizophrenia), kidney||
2105|102|P|disease.||
2105|103|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2105|104|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2105|105|P|machinery, or do anything that needs alertness until you can do||
2105|106|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2105|107|P|are using marijuana (cannabis).||
2105|108|P|   Before having surgery, tell your doctor or dentist about all||
2105|109|P|the products you use (including prescription drugs,||
2105|110|P|nonprescription drugs, and herbal products).||
2105|111|P|   During pregnancy, this medication should be used only when||
2105|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
2105|113|P|   It is unknown if this medication passes into breast milk.||
2105|114|P|Consult your doctor before breastfeeding.||
2105|115|B|||
2105|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2105|117|I|medications work or increase your risk for serious side effects.||
2105|118|I|This document does not contain all possible drug interactions.||
2105|119|I|Keep a list of all the products you use (including||
2105|120|I|prescription/nonprescription drugs and herbal products) and share||
2105|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
2105|122|I|the dosage of any medicines without your doctor's approval.||
2105|123|I|   Tell your doctor or pharmacist if you are taking other||
2105|124|I|products that cause drowsiness such as opioid pain or cough||
2105|125|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2105|126|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2105|127|I|lorazepam, zolpidem), other muscle relaxants (such as||
2105|128|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2105|129|I|cetirizine, diphenhydramine).||
2105|130|I|   Check the labels on all your medicines (such as allergy or||
2105|131|I|cough-and-cold products) because they may contain ingredients||
2105|132|I|that cause drowsiness. Ask your pharmacist about using those||
2105|133|I|products safely.||
2105|134|B|||
2105|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2105|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2105|137|O|poison control center right away. US residents can call||
2105|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2105|139|O|Symptoms of overdose may include: severe drowsiness, slow/shallow||
2105|140|O|breathing, seizures, severe muscle weakness, loss of||
2105|141|O|consciousness.||
2105|142|B|||
2105|143|N|NOTES:  Keep all medical and lab appointments.||
2105|144|N|   Keep all of your appointments to refill the medication. If you||
2105|145|N|plan to travel, talk with your doctor ahead of time about your||
2105|146|N|refill schedule so you do not run out of medication while you are||
2105|147|N|away from home.||
2105|148|B|||
2105|149|D|MISSED DOSE:  This drug is to be given continuously as an||
2105|150|D|infusion. If your infusion is interrupted, contact your doctor or||
2105|151|D|pharmacist right away. If you miss an appointment to refill the||
2105|152|D|medication, contact your doctor right away to reschedule before||
2105|153|D|the pump runs out of drug.||
2105|154|B|||
2105|155|R|STORAGE:  Consult the product instructions and your pharmacist||
2105|156|R|for storage details. Keep all medications away from children and||
2105|157|R|pets.||
2105|158|R|   Do not flush medications down the toilet or pour them into a||
2105|159|R|drain unless instructed to do so. Properly discard this product||
2105|160|R|when it is expired or no longer needed. Consult your pharmacist||
2105|161|R|or local waste disposal company.||
2105|162|B|||
2105|163|A|Information last revised November 2024.||
2105|164|A|Copyright(c) 2025 First Databank, Inc.||
2105|165|B|||
2106|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2106|002|Z|does NOT have all possible information about this product. This||
2106|003|Z|information does not assure that this product is safe, effective,||
2106|004|Z|or appropriate for you. This information is not individual||
2106|005|Z|medical advice and does not substitute for the advice of your||
2106|006|Z|health care professional. Always ask your health care||
2106|007|Z|professional for complete information about this product and your||
2106|008|Z|specific health needs.||
2106|009|B|||
2106|010|T|IRON/VITAMIN C/VITAMIN B12/INTRINSIC FACTOR - ORAL||
2106|011|B|||
2106|012|C|COMMON BRAND NAME(S): Foltrin||
2106|013|B|||
2106|014|W|WARNING:  Accidental overdose of iron-containing products is a||
2106|015|W|leading cause of fatal poisoning in children younger than 6||
2106|016|W|years. Keep this product out of reach of children. If overdose||
2106|017|W|does occur, get medical help right away or call a poison control||
2106|018|W|center.||
2106|019|B|||
2106|020|U|USES:  This medication is a multivitamin product used to treat or||
2106|021|U|prevent low blood levels of iron (such as those caused by anemia||
2106|022|U|or pregnancy). Iron is an important mineral the body needs to||
2106|023|U|produce red blood cells and keep you in good health. Vitamin C||
2106|024|U|improves the absorption of iron from the stomach. Vitamin B12 is||
2106|025|U|important for growth, cell production, and nerve function.||
2106|026|U|Intrinsic factor is identical to a substance that is made||
2106|027|U|naturally in the stomach. It improves the absorption of vitamin||
2106|028|U|B12.||
2106|029|B|||
2106|030|H|HOW TO USE:  Swallow this medication whole with a full glass of||
2106|031|H|water (8 ounces or 240 milliliters), usually once daily or as||
2106|032|H|directed by your doctor. If you are taking the long-acting||
2106|033|H|product, do not crush or chew the capsules. Doing so can destroy||
2106|034|H|the long action of the drug and may increase side effects.||
2106|035|H|   This medication is best taken on an empty stomach 1 hour||
2106|036|H|before or 2 hours after a meal. If stomach upset occurs, you may||
2106|037|H|take this medication with food. Avoid taking antacids, dairy||
2106|038|H|products, tea, or coffee within 2 hours before or after this||
2106|039|H|medication because they will decrease its effectiveness. Do not||
2106|040|H|lie down for at least 10 minutes after taking this medication.||
2106|041|H|   Take this medication regularly in order to get the most||
2106|042|H|benefit from it. To help you remember, take it at the same time||
2106|043|H|each day. Do not take more than the prescribed dose.||
2106|044|B|||
2106|045|S|SIDE EFFECTS:  Constipation, flushing, diarrhea, or upset stomach||
2106|046|S|may occur. These effects are usually temporary and may disappear||
2106|047|S|as your body adjusts to this medication. If any of these effects||
2106|048|S|last or get worse, tell your doctor or pharmacist promptly.||
2106|049|S|   Iron may cause your stools to turn black, which is not||
2106|050|S|harmful.||
2106|051|S|   Remember that this medication has been prescribed because your||
2106|052|S|doctor has judged that the benefit to you is greater than the||
2106|053|S|risk of side effects. Many people using this medication do not||
2106|054|S|have serious side effects.||
2106|055|S|   A very serious allergic reaction to this drug is rare.||
2106|056|S|However, get medical help right away if you notice any symptoms||
2106|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2106|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2106|059|S|breathing.||
2106|060|S|   This is not a complete list of possible side effects. If you||
2106|061|S|notice other effects not listed above, contact your doctor or||
2106|062|S|pharmacist.||
2106|063|S|   In the US -||
2106|064|S|   Call your doctor for medical advice about side effects. You||
2106|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2106|066|S|www.fda.gov/medwatch.||
2106|067|S|   In Canada - Call your doctor for medical advice about side||
2106|068|S|effects. You may report side effects to Health Canada at||
2106|069|S|1-866-234-2345.||
2106|070|B|||
2106|071|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2106|072|P|pharmacist if you are allergic to any of its ingredients; or if||
2106|073|P|you have any other allergies. This product may contain inactive||
2106|074|P|ingredients, which can cause allergic reactions or other||
2106|075|P|problems. Talk to your pharmacist for more details.||
2106|076|P|   Before taking this product, tell your doctor or pharmacist||
2106|077|P|your medical history, especially of: iron overload disorder (such||
2106|078|P|as hemochromatosis, hemosiderosis), use/abuse of alcohol, liver||
2106|079|P|problems, stomach/intestinal problems (such as ulcer, colitis),||
2106|080|P|vitamin B12 deficiency (pernicious anemia).||
2106|081|P|   Before having surgery, tell your doctor or dentist about all||
2106|082|P|the products you use (including prescription drugs,||
2106|083|P|nonprescription drugs, and herbal products).||
2106|084|P|   During pregnancy, this medication should be used only if||
2106|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
2106|086|P|   This medication passes into breast milk. Consult your doctor||
2106|087|P|before breastfeeding.||
2106|088|B|||
2106|089|I|DRUG INTERACTIONS:  See also How To Use section.||
2106|090|I|   Drug interactions may change how your medications work or||
2106|091|I|increase your risk for serious side effects. This document does||
2106|092|I|not contain all possible drug interactions. Keep a list of all||
2106|093|I|the products you use (including prescription/nonprescription||
2106|094|I|drugs and herbal products) and share it with your doctor and||
2106|095|I|pharmacist. Do not start, stop, or change the dosage of any||
2106|096|I|medicines without your doctor's approval.||
2106|097|I|   This product can decrease the absorption of certain drugs,||
2106|098|I|especially if you take them around the same time. These drugs||
2106|099|I|include bisphosphonates (such as alendronate), levodopa,||
2106|100|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
2106|101|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
2106|102|I|minocycline), thyroid medications (such as levothyroxine), among||
2106|103|I|others. Ask your doctor or pharmacist how long you should wait||
2106|104|I|between doses of this product and your other medications and to||
2106|105|I|find a dosing schedule that works for all your medications.||
2106|106|I|   This medication may interfere with certain lab tests (such as||
2106|107|I|fecal occult blood tests), possibly causing false test results.||
2106|108|I|Make sure lab personnel and all your doctors know you use this||
2106|109|I|drug.||
2106|110|B|||
2106|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2106|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2106|113|O|poison control center right away. US residents can call||
2106|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2106|115|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
2106|116|O|diarrhea.||
2106|117|B|||
2106|118|N|NOTES:  Do not share this medication with others.||
2106|119|N|   Lab and/or medical tests (such as complete blood count,||
2106|120|N|vitamin B12 levels) may be done while you are taking this||
2106|121|N|product. Keep all medical and lab appointments. Consult your||
2106|122|N|doctor for more details.||
2106|123|N|   There are many iron supplement products available. Some can be||
2106|124|N|purchased without a prescription. Consult your doctor or||
2106|125|N|pharmacist for details.||
2106|126|N|   This medication is not a substitute for a proper diet. It is||
2106|127|N|important to maintain a well-balanced diet. Foods rich in iron||
2106|128|N|include red meats (especially liver), fish, beans, dried fruit,||
2106|129|N|and iron-fortified/enriched cereals and bread.||
2106|130|B|||
2106|131|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2106|132|D|remember. If it is near the time of the next dose, skip the||
2106|133|D|missed dose. Take your next dose at the regular time. Do not||
2106|134|D|double the dose to catch up.||
2106|135|B|||
2106|136|R|STORAGE:  Store at room temperature away from light and moisture.||
2106|137|R|Do not store in the bathroom. Keep all medications away from||
2106|138|R|children and pets.||
2106|139|R|   Do not flush medications down the toilet or pour them into a||
2106|140|R|drain unless instructed to do so. Properly discard this product||
2106|141|R|when it is expired or no longer needed. Consult your pharmacist||
2106|142|R|or local waste disposal company.||
2106|143|B|||
2106|144|A|Information last revised October 2025.||
2106|145|A|Copyright(c) 2025 First Databank, Inc.||
2106|146|B|||
2107|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2107|002|Z|does NOT have all possible information about this product. This||
2107|003|Z|information does not assure that this product is safe, effective,||
2107|004|Z|or appropriate for you. This information is not individual||
2107|005|Z|medical advice and does not substitute for the advice of your||
2107|006|Z|health care professional. Always ask your health care||
2107|007|Z|professional for complete information about this product and your||
2107|008|Z|specific health needs.||
2107|009|B|||
2107|010|T|BIOTIN - ORAL||
2107|011|F|(BYE-oh-tin)||
2107|012|B|||
2107|013|C|COMMON BRAND NAME(S): Cyto B7, Hard Nails, Meribin, VB7 Max||
2107|014|B|||
2107|015|U|USES:  Biotin (vitamin B7) is used to prevent or treat low levels||
2107|016|U|of vitamin B7 in people who do not get enough of the vitamin from||
2107|017|U|their diets. Most people who eat a normal diet do not need extra||
2107|018|U|vitamin B7. However, some conditions (such as pregnancy,||
2107|019|U|parenteral nutrition, rapid weight loss) can cause low levels of||
2107|020|U|vitamin B7.||
2107|021|B|||
2107|022|H|HOW TO USE:  Take this medication by mouth as directed, usually||
2107|023|H|once daily. Follow all directions on the product package. If your||
2107|024|H|doctor has prescribed this product, take it as directed. If you||
2107|025|H|have any questions, ask your doctor or pharmacist.||
2107|026|H|   If you are taking chewable tablets, chew the tablet well and||
2107|027|H|swallow.||
2107|028|H|   If you are taking extended-release tablets, swallow them||
2107|029|H|whole. Do not crush or chew extended-release tablets. Doing so||
2107|030|H|can release all of the drug at once, increasing the risk of side||
2107|031|H|effects. Also, do not split extended-release tablets unless they||
2107|032|H|have a score line and your doctor or pharmacist tells you to do||
2107|033|H|so. Swallow the whole or split tablet without crushing or||
2107|034|H|chewing.||
2107|035|H|   If you are using the rapidly-dissolving tablet, allow the||
2107|036|H|tablet to dissolve under the tongue and then swallow, with or||
2107|037|H|without water.||
2107|038|H|   If you are using the liquid form of this medication, carefully||
2107|039|H|measure the dose using a special measuring device/spoon. Do not||
2107|040|H|use a household spoon because you may not get the correct dose.||
2107|041|H|Some liquid products need to be shaken before each dose.||
2107|042|H|   If you are using the powder form of this medication, prepare||
2107|043|H|the medication as directed by the product package.||
2107|044|H|   Take this vitamin regularly to get the most benefit from it.||
2107|045|H|To help you remember, take it at the same time each day.||
2107|046|H|   If your condition lasts or gets worse, or if you think you may||
2107|047|H|have a serious medical problem, get medical help right away.||
2107|048|B|||
2107|049|S|SIDE EFFECTS:  This vitamin usually has no side effects. If you||
2107|050|S|have any unusual effects, contact your doctor or pharmacist||
2107|051|S|promptly.||
2107|052|S|   If your doctor has directed you to use this medication,||
2107|053|S|remember that your doctor has judged that the benefit to you is||
2107|054|S|greater than the risk of side effects. Many people using this||
2107|055|S|medication do not have serious side effects.||
2107|056|S|   A very serious allergic reaction to this drug is rare.||
2107|057|S|However, get medical help right away if you notice any symptoms||
2107|058|S|of a serious allergic reaction, including: rash, itching/swelling||
2107|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2107|060|S|breathing.||
2107|061|S|   This is not a complete list of possible side effects. If you||
2107|062|S|notice other effects not listed above, contact your doctor or||
2107|063|S|pharmacist.||
2107|064|S|   In the US -||
2107|065|S|   Call your doctor for medical advice about side effects. You||
2107|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2107|067|S|www.fda.gov/medwatch.||
2107|068|S|   In Canada - Call your doctor for medical advice about side||
2107|069|S|effects. You may report side effects to Health Canada at||
2107|070|S|1-866-234-2345.||
2107|071|B|||
2107|072|P|PRECAUTIONS:  Before taking biotin, tell your doctor or||
2107|073|P|pharmacist if you are allergic to any of its ingredients; or if||
2107|074|P|you have any other allergies. This product may contain inactive||
2107|075|P|ingredients, which can cause allergic reactions or other||
2107|076|P|problems. Talk to your pharmacist for more details.||
2107|077|P|   Chewable tablets or liquid products may contain aspartame. If||
2107|078|P|you have phenylketonuria (PKU) or any other condition that||
2107|079|P|requires you to limit/avoid aspartame (or phenylalanine) in your||
2107|080|P|diet, consult your doctor or pharmacist about using this drug||
2107|081|P|safely.||
2107|082|P|   Liquid forms of this product may contain sugar and/or alcohol.||
2107|083|P|Caution is advised if you have diabetes, alcohol dependence, or||
2107|084|P|liver disease. Ask your doctor or pharmacist about using this||
2107|085|P|product safely.||
2107|086|P|   Before having surgery, tell your doctor or dentist about all||
2107|087|P|the products you use (including prescription drugs,||
2107|088|P|nonprescription drugs, and herbal products).||
2107|089|P|   During pregnancy, this product should be used only when||
2107|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
2107|091|P|   It is unknown if this product passes into breast milk. Consult||
2107|092|P|your doctor before breastfeeding.||
2107|093|B|||
2107|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2107|095|I|medications work or increase your risk for serious side effects.||
2107|096|I|This document does not contain all possible drug interactions.||
2107|097|I|Keep a list of all the products you use (including||
2107|098|I|prescription/nonprescription drugs and herbal products) and share||
2107|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2107|100|I|the dosage of any medicines without your doctor's approval.||
2107|101|I|   This product may interfere with certain lab tests (such as||
2107|102|I|thyroid tests), possibly causing false test results. Make sure||
2107|103|I|lab personnel and all your doctors know you use this product.||
2107|104|B|||
2107|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2107|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2107|107|O|poison control center right away. US residents can call||
2107|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2107|109|B|||
2107|110|N|NOTES:  Keep all medical and lab appointments.||
2107|111|N|   Remember that it is best to get your vitamins and minerals||
2107|112|N|from food whenever possible. Eat a well-balanced diet, and follow||
2107|113|N|any dietary guidelines as directed by your doctor. Foods rich in||
2107|114|N|biotin include eggs and milk.||
2107|115|B|||
2107|116|D|MISSED DOSE:  If you are taking this product on a regular||
2107|117|D|schedule and miss a dose, take it as soon as you remember. If it||
2107|118|D|is near the time of the next dose, skip the missed dose. Take||
2107|119|D|your next dose at the regular time. Do not double the dose to||
2107|120|D|catch up.||
2107|121|B|||
2107|122|R|STORAGE:  Different brands of this vitamin have different storage||
2107|123|R|needs. Check the product package for instructions on how to store||
2107|124|R|your brand, or ask your pharmacist. Do not store in the bathroom.||
2107|125|R|Keep all medications away from children and pets.||
2107|126|R|   Do not flush medications down the toilet or pour them into a||
2107|127|R|drain unless instructed to do so. Properly discard this product||
2107|128|R|when it is expired or no longer needed. Consult your pharmacist||
2107|129|R|or local waste disposal company.||
2107|130|B|||
2107|131|A|Information last revised February 2025.||
2107|132|A|Copyright(c) 2025 First Databank, Inc.||
2107|133|B|||
2108|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2108|002|Z|does NOT have all possible information about this product. This||
2108|003|Z|information does not assure that this product is safe, effective,||
2108|004|Z|or appropriate for you. This information is not individual||
2108|005|Z|medical advice and does not substitute for the advice of your||
2108|006|Z|health care professional. Always ask your health care||
2108|007|Z|professional for complete information about this product and your||
2108|008|Z|specific health needs.||
2108|009|B|||
2108|010|T|MYCOPHENOLATE MOFETIL - ORAL||
2108|011|F|(my-coh-FEN-oh-late MOW-fet-ill)||
2108|012|B|||
2108|013|C|COMMON BRAND NAME(S): Cellcept||
2108|014|B|||
2108|015|W|WARNING:  Mycophenolate may lower your ability to fight||
2108|016|W|infections. This may make you more likely to get a serious||
2108|017|W|(rarely fatal) infection or make any infection you have worse.||
2108|018|W|Tell your doctor right away if you have any signs of infection||
2108|019|W|(such as sore throat that doesn't go away, fever, chills,||
2108|020|W|burning/painful/urgent urination, change in the amount of urine).||
2108|021|W|   Mycophenolate may rarely cause cancer (such as lymphoma, skin||
2108|022|W|cancer). Protect your skin from the sun. Avoid prolonged sun||
2108|023|W|exposure, tanning booths, and sunlamps. Use a sunscreen and wear||
2108|024|W|protective clothing when outdoors. Tell your doctor right away if||
2108|025|W|you have any of the following symptoms of cancer: swollen lymph||
2108|026|W|nodes, sudden weight loss, night sweats, change in appearance or||
2108|027|W|size of moles, or unusual skin changes/growth.||
2108|028|W|   Mycophenolate may harm an unborn baby. When using||
2108|029|W|mycophenolate, men and women must use reliable forms of birth||
2108|030|W|control. See also Precautions section.||
2108|031|B|||
2108|032|U|USES:  Mycophenolate is used in combination with other||
2108|033|U|medications to keep your body from attacking and rejecting your||
2108|034|U|transplanted organ (such as kidney, liver, heart). It belongs to||
2108|035|U|a class of medications called immunosuppressants. It works by||
2108|036|U|weakening your body's defense system (immune system) to help your||
2108|037|U|body accept the new organ as if it were your own.||
2108|038|B|||
2108|039|V|OTHER USES:  This section contains uses of this drug that are not||
2108|040|V|listed in the approved professional labeling for the drug but||
2108|041|V|that may be prescribed by your health care professional. Use this||
2108|042|V|drug for a condition that is listed in this section only if it||
2108|043|V|has been so prescribed by your health care professional.||
2108|044|V|   This drug may also be used for immune system disorders.||
2108|045|B|||
2108|046|H|HOW TO USE:  Read the Medication Guide provided by your||
2108|047|H|pharmacist before you start taking mycophenolate and each time||
2108|048|H|you get a refill. If you have any questions, ask your doctor or||
2108|049|H|pharmacist.||
2108|050|H|   Take this medication by mouth as directed by your doctor,||
2108|051|H|usually twice daily on an empty stomach, 1 hour before or 2 hours||
2108|052|H|after meals.||
2108|053|H|   Swallow the medication whole. Do not crush or chew. If you are||
2108|054|H|taking the capsules, do not open them before swallowing.||
2108|055|H|   If the capsule comes apart or if there is dust from the||
2108|056|H|tablets, avoid inhaling the powder or dust, and avoid direct||
2108|057|H|contact with the skin or eyes. If contact occurs, wash the||
2108|058|H|affected skin area well with soap and water or rinse your eyes||
2108|059|H|with plain water. Consult your pharmacist for details.||
2108|060|H|   Since this drug can be absorbed through the skin and lungs and||
2108|061|H|may harm an unborn baby, women who are pregnant or who may become||
2108|062|H|pregnant should not handle this medication or breathe the dust||
2108|063|H|from the tablets or powder from the capsules.||
2108|064|H|   The dosage is based on your medical condition and response to||
2108|065|H|treatment. Children's dosage is also based on body size.||
2108|066|H|   Use this medication regularly to get the most benefit from it.||
2108|067|H|To help you remember, take it at the same times each day.||
2108|068|H|   Keep taking this medication even if you feel well. Do not stop||
2108|069|H|taking mycophenolate without first talking to your doctor.||
2108|070|H|   Certain products may make it harder for your body to absorb||
2108|071|H|mycophenolate if they are taken at the same time. Do not take||
2108|072|H|this medication at the same time as antacids containing aluminum||
2108|073|H|and/or magnesium, cholestyramine, colestipol, or calcium-free||
2108|074|H|phosphate binders (such as aluminum products, lanthanum,||
2108|075|H|sevelamer). Ask your pharmacist for more details.||
2108|076|H|   Do not change brands or forms of mycophenolate unless directed||
2108|077|H|by your doctor.||
2108|078|B|||
2108|079|S|SIDE EFFECTS:  See also Warning section.||
2108|080|S|   Constipation, nausea, headache, diarrhea, vomiting, stomach||
2108|081|S|upset, gas, tremor, dizziness, drowsiness, or trouble sleeping||
2108|082|S|may occur. If any of these effects last or get worse, tell your||
2108|083|S|doctor or pharmacist promptly.||
2108|084|S|   Remember that this medication has been prescribed because your||
2108|085|S|doctor has judged that the benefit to you is greater than the||
2108|086|S|risk of side effects. Many people using this medication do not||
2108|087|S|have serious side effects.||
2108|088|S|   Tell your doctor right away if you have any serious side||
2108|089|S|effects, including: unusual tiredness, fast/irregular heartbeat,||
2108|090|S|easy bleeding/bruising, swelling of the feet or ankles, joint||
2108|091|S|pain/stiffness, muscle pain.||
2108|092|S|   Get medical help right away if you have any very serious side||
2108|093|S|effects, including: stomach/abdominal pain that doesn't go away,||
2108|094|S|black stools, vomit that looks like coffee grounds, chest pain,||
2108|095|S|shortness of breath/rapid breathing.||
2108|096|S|   This medication may increase your risk of getting a rare but||
2108|097|S|very serious (possibly fatal) brain infection (progressive||
2108|098|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2108|099|S|if you have any of these side effects: clumsiness, loss of||
2108|100|S|coordination/balance, weakness, sudden change in your thinking||
2108|101|S|(such as confusion, difficulty concentrating, memory loss),||
2108|102|S|difficulty talking/walking, seizure, vision changes.||
2108|103|S|   A very serious allergic reaction to this drug is rare.||
2108|104|S|However, get medical help right away if you notice any symptoms||
2108|105|S|of a serious allergic reaction, including: rash, itching/swelling||
2108|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2108|107|S|breathing.||
2108|108|S|   This is not a complete list of possible side effects. If you||
2108|109|S|notice other effects not listed above, contact your doctor or||
2108|110|S|pharmacist.||
2108|111|S|   In the US -||
2108|112|S|   Call your doctor for medical advice about side effects. You||
2108|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2108|114|S|www.fda.gov/medwatch.||
2108|115|S|   In Canada - Call your doctor for medical advice about side||
2108|116|S|effects. You may report side effects to Health Canada at||
2108|117|S|1-866-234-2345.||
2108|118|B|||
2108|119|P|PRECAUTIONS:  See also Warning section.||
2108|120|P|   Before taking mycophenolate mofetil, tell your doctor or||
2108|121|P|pharmacist if you are allergic to it; or to mycophenolic acid; or||
2108|122|P|to mycophenolate sodium; or if you have any other allergies. This||
2108|123|P|product may contain inactive ingredients, which can cause||
2108|124|P|allergic reactions or other problems. Talk to your pharmacist for||
2108|125|P|more details.||
2108|126|P|   Before using this medication, tell your doctor or pharmacist||
2108|127|P|your medical history, especially of: cancer, liver disease (such||
2108|128|P|as hepatitis B, hepatitis C), kidney disease, current/past||
2108|129|P|infections (such as herpes, shingles), stomach/intestinal||
2108|130|P|problems (such as ulcers), rare genetic disorders (such as||
2108|131|P|Lesch-Nyhan or Kelley-Seegmiller syndromes).||
2108|132|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2108|133|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2108|134|P|machinery, or do anything that needs alertness until you can do||
2108|135|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2108|136|P|are using marijuana (cannabis).||
2108|137|P|   Mycophenolate can make you more likely to get infections or||
2108|138|P|may make current infections worse. Stay away from anyone who has||
2108|139|P|an infection that may easily spread (such as chickenpox,||
2108|140|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2108|141|P|exposed to an infection or for more details.||
2108|142|P|   Tell your health care professional that you are using||
2108|143|P|mycophenolate mofetil before having any||
2108|144|P|immunizations/vaccinations. Avoid contact with people who have||
2108|145|P|recently received live vaccines (such as flu vaccine inhaled||
2108|146|P|through the nose).||
2108|147|P|   To lower the chance of getting cut, bruised, or injured, use||
2108|148|P|caution with sharp objects like razors and nail cutters, and||
2108|149|P|avoid activities such as contact sports.||
2108|150|P|   Before having surgery, tell your doctor or dentist about all||
2108|151|P|the products you use (including prescription drugs,||
2108|152|P|nonprescription drugs, and herbal products).||
2108|153|P|   Do not donate blood while using mycophenolate and for 6 weeks||
2108|154|P|after stopping this drug. Do not donate sperm while using||
2108|155|P|mycophenolate and for 90 days after stopping this drug.||
2108|156|P|   Since this drug can be absorbed through the skin and lungs and||
2108|157|P|may harm an unborn baby, women who are pregnant or who may become||
2108|158|P|pregnant should not handle this medication or breathe the dust||
2108|159|P|from the tablets or powder from the capsules.||
2108|160|P|   Tell your doctor if you are pregnant or plan to become||
2108|161|P|pregnant. You should not become pregnant while using||
2108|162|P|mycophenolate. Mycophenolate may harm an unborn baby. Your doctor||
2108|163|P|should order a pregnancy test before you start this medication.||
2108|164|P|Women using this medication should ask about reliable forms of||
2108|165|P|birth control during treatment and for 6 weeks after the last||
2108|166|P|dose. Men using this medication should ask about reliable forms||
2108|167|P|of birth control during treatment and for 3 months after the last||
2108|168|P|dose. If you or your partner becomes pregnant, talk to your||
2108|169|P|doctor right away about the risks and benefits of this||
2108|170|P|medication.||
2108|171|P|   It is unknown if this drug passes into breast milk. Because of||
2108|172|P|the possible risk to the infant, breastfeeding is not recommended||
2108|173|P|while using this drug. Consult your doctor before breastfeeding.||
2108|174|B|||
2108|175|I|DRUG INTERACTIONS:  See also How to Use section.||
2108|176|I|   Drug interactions may change how your medications work or||
2108|177|I|increase your risk for serious side effects. This document does||
2108|178|I|not contain all possible drug interactions. Keep a list of all||
2108|179|I|the products you use (including prescription/nonprescription||
2108|180|I|drugs and herbal products) and share it with your doctor and||
2108|181|I|pharmacist. Do not start, stop, or change the dosage of any||
2108|182|I|medicines without your doctor's approval.||
2108|183|I|   Some products that may interact with this drug include: other||
2108|184|I|drugs that weaken the immune system/increase the risk of||
2108|185|I|infection (such as natalizumab, rituximab).||
2108|186|I|   This medication may decrease the effectiveness of hormonal||
2108|187|I|birth control such as pills, patch, or ring. This could cause||
2108|188|I|pregnancy. Discuss with your doctor or pharmacist about using a||
2108|189|I|reliable backup birth control method while using this medication.||
2108|190|I|Also tell your doctor if you have any new spotting or||
2108|191|I|breakthrough bleeding, because these may be signs that your birth||
2108|192|I|control is not working well.||
2108|193|B|||
2108|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2108|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2108|196|O|poison control center right away. US residents can call||
2108|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2108|198|B|||
2108|199|N|NOTES:  Do not share this medication with others.||
2108|200|N|   Lab and/or medical tests (such as blood counts, drug levels,||
2108|201|N|kidney function, pregnancy test) should be done while you are||
2108|202|N|taking this medication. Keep all medical and lab appointments.||
2108|203|N|Consult your doctor for more details.||
2108|204|N|   Attend a transplant education class or support group. Learn to||
2108|205|N|recognize the signs and symptoms of organ rejection and tell your||
2108|206|N|doctor right away if they occur.||
2108|207|B|||
2108|208|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2108|209|D|remember. If it is near the time of the next dose, skip the||
2108|210|D|missed dose. Take your next dose at the regular time. Do not||
2108|211|D|double the dose to catch up.||
2108|212|B|||
2108|213|R|STORAGE:  Store at room temperature away from light and moisture.||
2108|214|R|Do not store in the bathroom. Keep all medications away from||
2108|215|R|children and pets.||
2108|216|R|   Do not flush medications down the toilet or pour them into a||
2108|217|R|drain unless instructed to do so. Properly discard this product||
2108|218|R|when it is expired or no longer needed. Consult your pharmacist||
2108|219|R|or local waste disposal company.||
2108|220|B|||
2108|221|M|MEDICAL ALERT:  Your condition can cause complications in a||
2108|222|M|medical emergency. For information about enrolling in MedicAlert,||
2108|223|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2108|224|B|||
2108|225|A|Information last revised May 2025.||
2108|226|A|Copyright(c) 2025 First Databank, Inc.||
2108|227|B|||
2109|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2109|002|Z|does NOT have all possible information about this product. This||
2109|003|Z|information does not assure that this product is safe, effective,||
2109|004|Z|or appropriate for you. This information is not individual||
2109|005|Z|medical advice and does not substitute for the advice of your||
2109|006|Z|health care professional. Always ask your health care||
2109|007|Z|professional for complete information about this product and your||
2109|008|Z|specific health needs.||
2109|009|B|||
2109|010|T|BISACODYL ENEMA - RECTAL||
2109|011|F|(bis-AK-oh-dil)||
2109|012|B|||
2109|013|U|USES:  This product is used to clean stool from the intestines||
2109|014|U|before surgery or certain bowel procedures (such as colonoscopy,||
2109|015|U|radiography) usually with other products. It may also be used for||
2109|016|U|relief of constipation. However, milder products (such as||
2109|017|U|laxatives taken by mouth) should be used whenever possible for||
2109|018|U|constipation.||
2109|019|U|   Bisacodyl is a stimulant laxative that works by increasing the||
2109|020|U|amount of fluid/salts in the intestines. This effect usually||
2109|021|U|results in a bowel movement within 15 to 60 minutes.||
2109|022|U|   This product is not recommended for use in children younger||
2109|023|U|than 12 years unless directed by a doctor.||
2109|024|B|||
2109|025|H|HOW TO USE:  This product is for rectal use only. Read and follow||
2109|026|H|all directions on the product package at least 24 to 48 hours||
2109|027|H|before your surgery/procedure, or use as directed by your doctor.||
2109|028|H|If you have any questions, ask your doctor or pharmacist. Be sure||
2109|029|H|to also follow any diet instructions given by your doctor or||
2109|030|H|medical staff for your surgery/procedure. If you are using this||
2109|031|H|product for constipation, use as directed by your doctor.||
2109|032|H|   Wash your hands before and after using this product. Shake the||
2109|033|H|bottle well before removing the protective shield. Lie on your||
2109|034|H|left side with knee bent. Instead, if you find it more||
2109|035|H|comfortable, you may kneel, then lower your head and chest||
2109|036|H|forward until the left side of the face is resting on the surface||
2109|037|H|with your left arm folded comfortably. With steady pressure,||
2109|038|H|gently insert enema tip into the rectum with a slight||
2109|039|H|side-to-side movement, pointing the tip toward the navel. Do not||
2109|040|H|force the enema tip into the rectum because doing so can cause||
2109|041|H|injury. Squeeze the bottle until nearly all of the liquid is||
2109|042|H|inside the rectum. It is not necessary to empty the bottle||
2109|043|H|completely because it has more liquid than needed. Remove the||
2109|044|H|bottle tip from the rectum. Stay in position for 15 to 20 minutes||
2109|045|H|if possible until you feel a strong urge to have a bowel||
2109|046|H|movement.||
2109|047|H|   If this product is used too often, it may cause loss of normal||
2109|048|H|bowel function and an inability to have a bowel movement without||
2109|049|H|using the product (laxative dependence). If you notice symptoms||
2109|050|H|of overuse such as diarrhea, abdominal pain, decreased weight, or||
2109|051|H|weakness, contact your doctor promptly.||
2109|052|H|   If you are using this product to prepare for surgery/bowel||
2109|053|H|procedure, contact your doctor promptly if you do not have a||
2109|054|H|bowel movement within 2 hours of using this product. Your doctor||
2109|055|H|may need to give you other directions.||
2109|056|H|   Get medical help right away if you think you may have a||
2109|057|H|serious medical problem.||
2109|058|B|||
2109|059|S|SIDE EFFECTS:  Rectal irritation/burning/itching, mild abdominal||
2109|060|S|discomfort/cramps, or nausea may occur. If any of these effects||
2109|061|S|last or get worse, tell your doctor or pharmacist promptly.||
2109|062|S|   If your doctor has directed you to use this product, remember||
2109|063|S|that your doctor has judged that the benefit to you is greater||
2109|064|S|than the risk of side effects. Many people using this product do||
2109|065|S|not have serious side effects.||
2109|066|S|   Tell your doctor right away if you have any serious side||
2109|067|S|effects, including: diarrhea that doesn't stop, rectal||
2109|068|S|bleeding/blisters.||
2109|069|S|   Diarrhea that doesn't stop may result in dehydration. Contact||
2109|070|S|your doctor promptly if you notice any symptoms of dehydration||
2109|071|S|such as unusual decreased urination, unusual dry mouth/thirst,||
2109|072|S|fast heartbeat, or dizziness/lightheadedness.||
2109|073|S|   A very serious allergic reaction to this drug is rare.||
2109|074|S|However, get medical help right away if you notice any symptoms||
2109|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2109|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2109|077|S|breathing.||
2109|078|S|   This is not a complete list of possible side effects. If you||
2109|079|S|notice other effects not listed above, contact your doctor or||
2109|080|S|pharmacist.||
2109|081|S|   In the US -||
2109|082|S|   Call your doctor for medical advice about side effects. You||
2109|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2109|084|S|www.fda.gov/medwatch.||
2109|085|S|   In Canada - Call your doctor for medical advice about side||
2109|086|S|effects. You may report side effects to Health Canada at||
2109|087|S|1-866-234-2345.||
2109|088|B|||
2109|089|P|PRECAUTIONS:  Before using bisacodyl, tell your doctor or||
2109|090|P|pharmacist if you are allergic to it; or if you have any other||
2109|091|P|allergies. This product may contain inactive ingredients, which||
2109|092|P|can cause allergic reactions or other problems. Talk to your||
2109|093|P|pharmacist for more details.||
2109|094|P|   Before using this medication, tell your doctor or pharmacist||
2109|095|P|your medical history, especially of: other bowel problems (such||
2109|096|P|as blockage, ulcerative colitis, hemorrhoids, rectal bleeding),||
2109|097|P|current stomach/abdominal symptoms (such as nausea/vomiting that||
2109|098|P|doesn't stop, pain, cramping).||
2109|099|P|   Before having surgery, tell your doctor or dentist about all||
2109|100|P|the products you use (including prescription drugs,||
2109|101|P|nonprescription drugs, and herbal products).||
2109|102|P|   During pregnancy, this medication should be used only when||
2109|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
2109|104|P|   It is unknown if this drug passes into breast milk. Consult||
2109|105|P|your doctor before breastfeeding.||
2109|106|B|||
2109|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2109|108|I|medications work or increase your risk for serious side effects.||
2109|109|I|This document does not contain all possible drug interactions.||
2109|110|I|Keep a list of all the products you use (including||
2109|111|I|prescription/nonprescription drugs and herbal products) and share||
2109|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2109|113|I|the dosage of any medicines without your doctor's approval.||
2109|114|B|||
2109|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2109|116|O|has overdosed and has serious symptoms such as passing out or||
2109|117|O|trouble breathing, call 911. Otherwise, call a poison control||
2109|118|O|center right away. US residents can call 1-800-222-1222. Canada||
2109|119|O|residents can call 1-844-764-7669.||
2109|120|B|||
2109|121|N|NOTES:  To maintain normal bowel habits, it is important to drink||
2109|122|N|plenty of fluids (four to six 8-ounce glasses daily), eat foods||
2109|123|N|high in fiber, and exercise regularly.||
2109|124|B|||
2109|125|D|MISSED DOSE:  Not applicable.||
2109|126|B|||
2109|127|R|STORAGE:  Refer to storage information on the package label. If||
2109|128|R|you have any questions about storage, ask your pharmacist. Keep||
2109|129|R|all medications away from children and pets.||
2109|130|R|   Do not flush medications down the toilet or pour them into a||
2109|131|R|drain unless instructed to do so. Properly discard this product||
2109|132|R|when it is expired or no longer needed. Consult your pharmacist||
2109|133|R|or local waste disposal company.||
2109|134|B|||
2109|135|A|Information last revised January 2025.||
2109|136|A|Copyright(c) 2025 First Databank, Inc.||
2109|137|B|||
2110|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2110|002|Z|does NOT have all possible information about this product. This||
2110|003|Z|information does not assure that this product is safe, effective,||
2110|004|Z|or appropriate for you. This information is not individual||
2110|005|Z|medical advice and does not substitute for the advice of your||
2110|006|Z|health care professional. Always ask your health care||
2110|007|Z|professional for complete information about this product and your||
2110|008|Z|specific health needs.||
2110|009|B|||
2110|010|T|SEMAGLUTIDE - ORAL||
2110|011|F|(SEM-a-GLOO-tide)||
2110|012|B|||
2110|013|C|COMMON BRAND NAME(S): Rybelsus||
2110|014|B|||
2110|015|W|WARNING:  This medication can cause a certain type of thyroid||
2110|016|W|tumor (thyroid C-cell tumors) in rats. It is unknown if this||
2110|017|W|medication can cause similar tumors in humans. Talk with your||
2110|018|W|doctor about the benefits and risks of treatment with this||
2110|019|W|medication. Do not use this medication if you have a||
2110|020|W|personal/family history of a certain type of cancer (medullary||
2110|021|W|thyroid carcinoma) or a certain inherited disease (multiple||
2110|022|W|endocrine neoplasia syndrome type 2 or MEN 2). While using this||
2110|023|W|medication, tell your doctor right away if you notice any signs||
2110|024|W|of thyroid tumors, including an unusual growth or lump in the||
2110|025|W|neck, difficulty swallowing, shortness of breath, unusual/lasting||
2110|026|W|hoarseness.||
2110|027|B|||
2110|028|U|USES:  Semaglutide is used with a proper diet and exercise||
2110|029|U|program to control high blood sugar in people with type 2||
2110|030|U|diabetes. Controlling high blood sugar helps prevent kidney||
2110|031|U|damage, blindness, nerve problems, loss of limbs, and sexual||
2110|032|U|function problems. Semaglutide is also used in people with type 2||
2110|033|U|diabetes to lower the risk of death from heart attack or stroke.||
2110|034|U|   Semaglutide is similar to a natural hormone in your body||
2110|035|U|(incretin). It works by causing insulin release in response to||
2110|036|U|high blood sugar (such as after a meal) and decreasing the amount||
2110|037|U|of sugar your liver makes.||
2110|038|B|||
2110|039|H|HOW TO USE:  Read the Medication Guide provided by your||
2110|040|H|pharmacist before you start taking semaglutide and each time you||
2110|041|H|get a refill. If you have any questions, ask your doctor or||
2110|042|H|pharmacist.||
2110|043|H|   Take this medication with a sip of plain water (no more than 4||
2110|044|H|ounces or 120 milliliters) as directed by your doctor, usually||
2110|045|H|once daily. Do not take it with any other beverage. Swallow the||
2110|046|H|tablet whole. Do not split, chew or crush the tablet. Wait at||
2110|047|H|least 30 minutes after taking semaglutide before you eat or drink||
2110|048|H|anything other than plain water and before taking any other||
2110|049|H|medication by mouth.||
2110|050|H|   For the best effect, you should eat 30 to 60 minutes after||
2110|051|H|taking semaglutide. It is important to take this medication the||
2110|052|H|same way with every dose.||
2110|053|H|   The dosage is based on your medical condition and response to||
2110|054|H|treatment.||
2110|055|H|   To reduce your risk of side effects, your doctor may direct||
2110|056|H|you to start this medication at a low dose and gradually increase||
2110|057|H|your dose. Follow your doctor's instructions carefully.||
2110|058|H|   Use this medication regularly to get the most benefit from it.||
2110|059|H|To help you remember, take it at the same time each day.||
2110|060|H|   Do not increase your dose or use this drug more often or for||
2110|061|H|longer than prescribed. Your condition will not improve any||
2110|062|H|faster, and your risk of side effects will increase.||
2110|063|H|   Tell your doctor if your condition does not get better or if||
2110|064|H|it gets worse (your blood sugar is too high or too low).||
2110|065|B|||
2110|066|S|SIDE EFFECTS:  See also Warning section.||
2110|067|S|   Nausea, vomiting, abdominal pain, loss of appetite, diarrhea,||
2110|068|S|or constipation may occur. Nausea usually lessens as you continue||
2110|069|S|to take semaglutide. If any of these effects last or get worse,||
2110|070|S|tell your doctor or pharmacist promptly.||
2110|071|S|   Remember that this medication has been prescribed because your||
2110|072|S|doctor has judged that the benefit to you is greater than the||
2110|073|S|risk of side effects. Many people using this medication do not||
2110|074|S|have serious side effects.||
2110|075|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2110|076|S|Contact your doctor promptly if you notice any symptoms of||
2110|077|S|dehydration, such as unusual dry mouth/thirst, fast heartbeat, or||
2110|078|S|dizziness/lightheadedness.||
2110|079|S|   Tell your doctor right away if you have any serious side||
2110|080|S|effects, including: signs of kidney problems (such as change in||
2110|081|S|the amount of urine), vision changes (such as decreased/blurred||
2110|082|S|vision).||
2110|083|S|   Get medical help right away if you have any very serious side||
2110|084|S|effects, including: signs of pancreas or gallbladder disease||
2110|085|S|(such as nausea/vomiting that doesn't stop, severe||
2110|086|S|stomach/abdominal pain).||
2110|087|S|   Semaglutide does not usually cause low blood sugar||
2110|088|S|(hypoglycemia). Low blood sugar may occur if this drug is||
2110|089|S|prescribed with other diabetes medications, or if you do not get||
2110|090|S|enough calories from food, or if you do unusually heavy exercise.||
2110|091|S|Talk with your doctor or pharmacist about whether the dose of||
2110|092|S|your other diabetes medication(s) needs to be lowered. Symptoms||
2110|093|S|of low blood sugar include sudden sweating, shaking, fast||
2110|094|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
2110|095|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
2110|096|S|treat low blood sugar. If you don't have these reliable forms of||
2110|097|S|glucose, rapidly raise your blood sugar by eating a quick source||
2110|098|S|of sugar such as table sugar, honey, or candy, or drink fruit||
2110|099|S|juice or non-diet soda. Tell your doctor right away about the||
2110|100|S|reaction and the use of this product. To help prevent low blood||
2110|101|S|sugar, eat meals on a regular schedule, and do not skip meals.||
2110|102|S|Check with your doctor or pharmacist to find out what you should||
2110|103|S|do if you miss a meal.||
2110|104|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
2110|105|S|thirst/urination. If these symptoms occur, tell your doctor right||
2110|106|S|away. Your doctor may need to adjust your diabetes medication,||
2110|107|S|exercise program, or diet.||
2110|108|S|   A very serious allergic reaction to this drug is rare.||
2110|109|S|However, get medical help right away if you notice any symptoms||
2110|110|S|of a serious allergic reaction, including: rash, itching/swelling||
2110|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2110|112|S|breathing.||
2110|113|S|   This is not a complete list of possible side effects. If you||
2110|114|S|notice other effects not listed above, contact your doctor or||
2110|115|S|pharmacist.||
2110|116|S|   In the US -||
2110|117|S|   Call your doctor for medical advice about side effects. You||
2110|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2110|119|S|www.fda.gov/medwatch.||
2110|120|S|   In Canada - Call your doctor for medical advice about side||
2110|121|S|effects. You may report side effects to Health Canada at||
2110|122|S|1-866-234-2345.||
2110|123|B|||
2110|124|P|PRECAUTIONS:  See also Warning section.||
2110|125|P|   Before taking semaglutide, tell your doctor or pharmacist if||
2110|126|P|you are allergic to it; or if you have any other allergies. This||
2110|127|P|product may contain inactive ingredients, which can cause||
2110|128|P|allergic reactions or other problems. Talk to your pharmacist for||
2110|129|P|more details.||
2110|130|P|   Before using this medication, tell your doctor or pharmacist||
2110|131|P|your medical history, especially of: a certain eye problem||
2110|132|P|(diabetic retinopathy), a disease of the pancreas (pancreatitis),||
2110|133|P|gallbladder disease, kidney problems, stomach/intestinal||
2110|134|P|disorders (such as gastroparesis, digestion problems).||
2110|135|P|   You may experience blurred vision, dizziness, or drowsiness||
2110|136|P|due to extremely low or high blood sugar. Do not drive, use||
2110|137|P|machinery, or do anything that needs alertness or clear vision||
2110|138|P|until you can do it safely.||
2110|139|P|   Limit alcohol while using this medication because it can||
2110|140|P|increase your risk of developing low blood sugar.||
2110|141|P|   It may be harder to control your blood sugar when your body is||
2110|142|P|stressed (such as due to fever, infection, injury, or surgery).||
2110|143|P|Consult your doctor because this may require a change in your||
2110|144|P|treatment plan, medications, or blood sugar testing.||
2110|145|P|   Before having surgery, tell your doctor or dentist about all||
2110|146|P|the products you use (including prescription drugs,||
2110|147|P|nonprescription drugs, and herbal products).||
2110|148|P|   During pregnancy, this medication should be used only when||
2110|149|P|clearly needed. If you are planning pregnancy, become pregnant,||
2110|150|P|or think you may be pregnant, discuss with your doctor right away||
2110|151|P|the benefits and risks of using this medication during pregnancy.||
2110|152|P|The manufacturer recommends stopping use of this medication 2||
2110|153|P|months before a planned pregnancy.||
2110|154|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
2110|155|P|your doctor for managing your blood sugar while pregnant. Your||
2110|156|P|doctor may change your diabetes treatment during your pregnancy||
2110|157|P|(such as diet and medications including insulin).||
2110|158|P|   This product passes into breast milk and may harm a nursing||
2110|159|P|infant. Breastfeeding is not recommended while using this||
2110|160|P|product. Consult your doctor before breastfeeding.||
2110|161|B|||
2110|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2110|163|I|medications work or increase your risk for serious side effects.||
2110|164|I|This document does not contain all possible drug interactions.||
2110|165|I|Keep a list of all the products you use (including||
2110|166|I|prescription/nonprescription drugs and herbal products) and share||
2110|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
2110|168|I|the dosage of any medicines without your doctor's approval.||
2110|169|I|   Beta-blocker medications (such as metoprolol, propranolol,||
2110|170|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
2110|171|I|heartbeat you would usually feel when your blood sugar falls too||
2110|172|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
2110|173|I|dizziness, hunger, or sweating, are not affected by these drugs.||
2110|174|I|   Many drugs can affect your blood sugar, making it harder to||
2110|175|I|control. Before you start, stop, or change any medication, talk||
2110|176|I|with your doctor or pharmacist about how the medication may||
2110|177|I|affect your blood sugar. Check your blood sugar regularly as||
2110|178|I|directed and share the results with your doctor. Tell your doctor||
2110|179|I|right away if you have symptoms of high or low blood sugar. (See||
2110|180|I|also Side Effects section.) Your doctor may need to adjust your||
2110|181|I|diabetes medication, exercise program, or diet.||
2110|182|B|||
2110|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2110|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2110|185|O|poison control center right away. US residents can call||
2110|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2110|187|B|||
2110|188|N|NOTES:  Do not share this medication with others.||
2110|189|N|   Attend a diabetes education program to learn more about how to||
2110|190|N|manage your diabetes with medications, diet, exercise, and||
2110|191|N|regular medical exams.||
2110|192|N|   Learn the symptoms of high and low blood sugar and how to||
2110|193|N|treat low blood sugar. Check your blood sugar regularly as||
2110|194|N|directed.||
2110|195|N|   Lab and/or medical tests (such as kidney function, fasting||
2110|196|N|blood glucose, hemoglobin A1c) should be done while you are||
2110|197|N|taking this medication. Keep all medical and lab appointments.||
2110|198|N|Consult your doctor for more details.||
2110|199|B|||
2110|200|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2110|201|D|next dose at the regular time. Do not double the dose to catch||
2110|202|D|up.||
2110|203|B|||
2110|204|R|STORAGE:  Store in the original container at room temperature||
2110|205|R|away from light and moisture. Do not store in the bathroom. Keep||
2110|206|R|all medications away from children and pets.||
2110|207|R|   Do not flush medications down the toilet or pour them into a||
2110|208|R|drain unless instructed to do so. Properly discard this product||
2110|209|R|when it is expired or no longer needed. Consult your pharmacist||
2110|210|R|or local waste disposal company.||
2110|211|B|||
2110|212|M|MEDICAL ALERT:  Your condition can cause complications in a||
2110|213|M|medical emergency. For information about enrolling in MedicAlert,||
2110|214|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2110|215|B|||
2110|216|A|Information last revised October 2025.||
2110|217|A|Copyright(c) 2025 First Databank, Inc.||
2110|218|B|||
2111|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2111|002|Z|does NOT have all possible information about this product. This||
2111|003|Z|information does not assure that this product is safe, effective,||
2111|004|Z|or appropriate for you. This information is not individual||
2111|005|Z|medical advice and does not substitute for the advice of your||
2111|006|Z|health care professional. Always ask your health care||
2111|007|Z|professional for complete information about this product and your||
2111|008|Z|specific health needs.||
2111|009|B|||
2111|010|T|ISTRADEFYLLINE - ORAL||
2111|011|F|(IS-tra-DEF-i-lin)||
2111|012|B|||
2111|013|C|COMMON BRAND NAME(S): Nourianz||
2111|014|B|||
2111|015|U|USES:  Istradefylline is used by people with Parkinson's disease||
2111|016|U|taking carbidopa/levodopa to reduce the amount of "off" time||
2111|017|U|(periods of slow movement or stiffness).||
2111|018|B|||
2111|019|H|HOW TO USE:  Take this medication by mouth with or without food||
2111|020|H|as directed by your doctor, usually once daily.||
2111|021|H|   The dosage is based on your medical condition, response to||
2111|022|H|treatment, and other medications you may be taking. Be sure to||
2111|023|H|tell your doctor and pharmacist about all the products you use||
2111|024|H|(including prescription drugs, nonprescription drugs, and herbal||
2111|025|H|products). Do not increase your dose or take it more often than||
2111|026|H|prescribed. Your condition will not improve any faster, and your||
2111|027|H|risk of side effects will increase.||
2111|028|H|   Tell your doctor if this medication stops working well or if||
2111|029|H|your condition gets worse.||
2111|030|B|||
2111|031|S|SIDE EFFECTS:  Dizziness, decreased appetite, or constipation may||
2111|032|S|occur. If any of these effects last or get worse, tell your||
2111|033|S|doctor or pharmacist promptly.||
2111|034|S|   Remember that this medication has been prescribed because your||
2111|035|S|doctor has judged that the benefit to you is greater than the||
2111|036|S|risk of side effects. Many people using this medication do not||
2111|037|S|have serious side effects.||
2111|038|S|   Tell your doctor right away if you have any serious side||
2111|039|S|effects, including: worsening muscle twitching/uncontrollable||
2111|040|S|movements, mental/mood changes (such as agitation,||
2111|041|S|hallucinations), unusual strong urges (such as increased||
2111|042|S|gambling, increased sexual urges).||
2111|043|S|   A very serious allergic reaction to this drug is rare.||
2111|044|S|However, get medical help right away if you notice any symptoms||
2111|045|S|of a serious allergic reaction, including: rash, itching/swelling||
2111|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2111|047|S|breathing.||
2111|048|S|   This is not a complete list of possible side effects. If you||
2111|049|S|notice other effects not listed above, contact your doctor or||
2111|050|S|pharmacist.||
2111|051|S|   In the US -||
2111|052|S|   Call your doctor for medical advice about side effects. You||
2111|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2111|054|S|www.fda.gov/medwatch.||
2111|055|S|   In Canada - Call your doctor for medical advice about side||
2111|056|S|effects. You may report side effects to Health Canada at||
2111|057|S|1-866-234-2345.||
2111|058|B|||
2111|059|P|PRECAUTIONS:  Before taking istradefylline, tell your doctor or||
2111|060|P|pharmacist if you are allergic to it; or if you have any other||
2111|061|P|allergies. This product may contain inactive ingredients, which||
2111|062|P|can cause allergic reactions or other problems. Talk to your||
2111|063|P|pharmacist for more details.||
2111|064|P|   Before using this medication, tell your doctor or pharmacist||
2111|065|P|your medical history, especially of: liver disease, mental/mood||
2111|066|P|disorders (such as schizophrenia, bipolar disorder).||
2111|067|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2111|068|P|can make you more dizzy. Do not drive, use machinery, or do||
2111|069|P|anything that needs alertness until you can do it safely. Limit||
2111|070|P|alcoholic beverages. Talk to your doctor if you are using||
2111|071|P|marijuana (cannabis).||
2111|072|P|   Before having surgery, tell your doctor or dentist about all||
2111|073|P|the products you use (including prescription drugs,||
2111|074|P|nonprescription drugs, and herbal products).||
2111|075|P|   During pregnancy, this medication should be used only when||
2111|076|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2111|077|P|benefits with your doctor.||
2111|078|P|   It is unknown if this drug passes into breast milk. Consult||
2111|079|P|your doctor before breastfeeding.||
2111|080|B|||
2111|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2111|082|I|medications work or increase your risk for serious side effects.||
2111|083|I|This document does not contain all possible drug interactions.||
2111|084|I|Keep a list of all the products you use (including||
2111|085|I|prescription/nonprescription drugs and herbal products) and share||
2111|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
2111|087|I|the dosage of any medicines without your doctor's approval.||
2111|088|I|   A product that may interact with this drug is: elacestrant.||
2111|089|I|   Other medications can affect the removal of istradefylline||
2111|090|I|from your body, which may affect how istradefylline works.||
2111|091|I|Examples include rifamycins (such as rifabutin, rifampin), St.||
2111|092|I|John's wort, drugs used to treat seizures (such as carbamazepine,||
2111|093|I|phenytoin), among others.||
2111|094|I|   Cigarette smoking decreases blood levels of this medication.||
2111|095|I|Tell your doctor if you smoke or if you have recently stopped||
2111|096|I|smoking.||
2111|097|B|||
2111|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2111|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2111|100|O|poison control center right away. US residents can call||
2111|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2111|102|O|Symptoms of overdose may include: mental/mood changes (such as||
2111|103|O|agitation, hallucinations).||
2111|104|B|||
2111|105|N|NOTES:  Do not share this medication with others.||
2111|106|B|||
2111|107|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2111|108|D|remember. If it is near the time of the next dose, skip the||
2111|109|D|missed dose. Take your next dose at the regular time. Do not||
2111|110|D|double the dose to catch up.||
2111|111|B|||
2111|112|R|STORAGE:  Store at room temperature away from light and moisture.||
2111|113|R|Do not store in the bathroom. Keep all medications away from||
2111|114|R|children and pets.||
2111|115|R|   Do not flush medications down the toilet or pour them into a||
2111|116|R|drain unless instructed to do so. Properly discard this product||
2111|117|R|when it is expired or no longer needed. Consult your pharmacist||
2111|118|R|or local waste disposal company.||
2111|119|B|||
2111|120|A|Information last revised May 2024.||
2111|121|A|Copyright(c) 2025 First Databank, Inc.||
2111|122|B|||
2112|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2112|002|Z|does NOT have all possible information about this product. This||
2112|003|Z|information does not assure that this product is safe, effective,||
2112|004|Z|or appropriate for you. This information is not individual||
2112|005|Z|medical advice and does not substitute for the advice of your||
2112|006|Z|health care professional. Always ask your health care||
2112|007|Z|professional for complete information about this product and your||
2112|008|Z|specific health needs.||
2112|009|B|||
2112|010|T|BENZOCAINE/MENTHOL LOZENGE - MUCOUS MEMBRANE (ORAL)||
2112|011|F|(BEN-zoe-kane/MEN-thol)||
2112|012|B|||
2112|013|C|COMMON BRAND NAME(S): Cepacol, Chloraseptic||
2112|014|B|||
2112|015|U|USES:  This product is used to temporarily relieve pain from||
2112|016|U|minor mouth problems (such as canker sores, sore gums/throat,||
2112|017|U|mouth/gum injury). Benzocaine is a local anesthetic that works by||
2112|018|U|numbing the painful area. Menthol works by providing a cooling||
2112|019|U|feeling and increasing saliva in the mouth.||
2112|020|U|   Do not use this product for children younger than 5 years due||
2112|021|U|to risk of serious side effects. Ask your doctor for more||
2112|022|U|details.||
2112|023|U|   Check the ingredients on the label even if you have used the||
2112|024|U|product before. The manufacturer may have changed the||
2112|025|U|ingredients. Also, products with similar names may contain||
2112|026|U|different ingredients meant for different purposes. Taking the||
2112|027|U|wrong product could harm you.||
2112|028|B|||
2112|029|H|HOW TO USE:  Read and follow all directions on the product||
2112|030|H|package before using this medication. If you have any questions,||
2112|031|H|consult your pharmacist. If your doctor has directed you to use||
2112|032|H|this product, use it as directed.||
2112|033|H|   Let the lozenge dissolve slowly in your mouth and swallow the||
2112|034|H|dissolved liquid along with your saliva. Do not chew or swallow||
2112|035|H|it whole.||
2112|036|H|   This product is usually used every 2 hours as needed. If your||
2112|037|H|doctor has directed you to use it, follow your doctor's||
2112|038|H|instructions on how to use it. Do not increase your dose or use||
2112|039|H|this drug more often or for longer than directed.||
2112|040|H|   If you have a sore throat that is severe or that lasts more||
2112|041|H|than 2 days, or a cough that lasts more than 7 days or keeps||
2112|042|H|coming back, or symptoms occur with a fever, headache, rash,||
2112|043|H|swelling, nausea, or vomiting, tell your doctor promptly. If sore||
2112|044|H|mouth/throat or cough symptoms do not get better or last more||
2112|045|H|than 7 days, see your doctor or dentist promptly. These could be||
2112|046|H|signs of a serious condition. If you think you may have a serious||
2112|047|H|medical problem, get medical help right away.||
2112|048|B|||
2112|049|S|SIDE EFFECTS:  Slight burning, tingling, or stinging may occur.||
2112|050|S|If any of these effects last or get worse, tell your doctor or||
2112|051|S|pharmacist promptly.||
2112|052|S|   If your doctor has directed you to use this product, remember||
2112|053|S|that your doctor has judged that the benefit to you is greater||
2112|054|S|than the risk of side effects. Many people using this product do||
2112|055|S|not have serious side effects.||
2112|056|S|   This product has rarely caused a very serious (possibly fatal)||
2112|057|S|blood disorder (methemoglobinemia). This effect is more likely if||
2112|058|S|you have breathing problems, certain diseases of the blood, or if||
2112|059|S|you smoke (see also Precautions section). The symptoms of this||
2112|060|S|disorder may occur within minutes to a couple of hours after||
2112|061|S|using this product. Stop using this product and get medical help||
2112|062|S|right away if you develop any symptoms of methemoglobinemia,||
2112|063|S|including: pale/bluish/gray skin, unusual tiredness, shortness of||
2112|064|S|breath, fast heartbeat, dizziness, headache, confusion.||
2112|065|S|   A very serious allergic reaction to this drug is rare.||
2112|066|S|However, get medical help right away if you notice any symptoms||
2112|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2112|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2112|069|S|breathing.||
2112|070|S|   This is not a complete list of possible side effects. If you||
2112|071|S|notice other effects not listed above, contact your doctor or||
2112|072|S|pharmacist.||
2112|073|S|   In the US -||
2112|074|S|   Call your doctor for medical advice about side effects. You||
2112|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2112|076|S|www.fda.gov/medwatch.||
2112|077|S|   In Canada - Call your doctor for medical advice about side||
2112|078|S|effects. You may report side effects to Health Canada at||
2112|079|S|1-866-234-2345.||
2112|080|B|||
2112|081|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2112|082|P|pharmacist if you are allergic to benzocaine or to menthol; or to||
2112|083|P|other "caine" anesthetics (such as procaine) or if you have any||
2112|084|P|other allergies. This product may contain inactive ingredients,||
2112|085|P|which can cause allergic reactions or other problems. Talk to||
2112|086|P|your pharmacist for more details.||
2112|087|P|   Before using this product, tell your doctor or pharmacist your||
2112|088|P|medical history, especially of: heart disease, certain blood||
2112|089|P|disorders (G6PD deficiency, pyruvate kinase deficiency,||
2112|090|P|hemoglobin-M disease, NADH-methemoglobin reductase deficiency),||
2112|091|P|breathing problems (such as asthma, bronchitis, emphysema,||
2112|092|P|smoking history).||
2112|093|P|   This product may contain sugar and/or aspartame. Caution is||
2112|094|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
2112|095|P|condition that requires you to limit/avoid these substances in||
2112|096|P|your diet. Ask your doctor or pharmacist about using this product||
2112|097|P|safely.||
2112|098|P|   Before having surgery, tell your doctor or dentist about all||
2112|099|P|the products you use (including prescription drugs,||
2112|100|P|nonprescription drugs, and herbal products).||
2112|101|P|   During pregnancy, this product should be used only when||
2112|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
2112|103|P|   It is unknown if benzocaine passes into breast milk. Menthol||
2112|104|P|passes into breast milk in small amounts. Consult your doctor||
2112|105|P|before breastfeeding.||
2112|106|B|||
2112|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2112|108|I|medications work or increase your risk for serious side effects.||
2112|109|I|This document does not contain all possible drug interactions.||
2112|110|I|Keep a list of all the products you use (including||
2112|111|I|prescription/nonprescription drugs and herbal products) and share||
2112|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2112|113|I|the dosage of any medicines without your doctor's approval.||
2112|114|B|||
2112|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2112|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2112|117|O|poison control center right away. US residents can call||
2112|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2112|119|O|Symptoms of overdose may include: slow/shallow breathing,||
2112|120|O|seizures, irregular heartbeat.||
2112|121|B|||
2112|122|N|NOTES:  Keep all medical and lab appointments.||
2112|123|B|||
2112|124|D|MISSED DOSE:  Not applicable.||
2112|125|B|||
2112|126|R|STORAGE:  Store at room temperature away from light and moisture.||
2112|127|R|Do not store in the bathroom. Keep all medications away from||
2112|128|R|children and pets.||
2112|129|R|   Do not flush medications down the toilet or pour them into a||
2112|130|R|drain unless instructed to do so. Properly discard this product||
2112|131|R|when it is expired or no longer needed. Consult your pharmacist||
2112|132|R|or local waste disposal company.||
2112|133|B|||
2112|134|A|Information last revised February 2025.||
2112|135|A|Copyright(c) 2025 First Databank, Inc.||
2112|136|B|||
2113|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2113|002|Z|does NOT have all possible information about this product. This||
2113|003|Z|information does not assure that this product is safe, effective,||
2113|004|Z|or appropriate for you. This information is not individual||
2113|005|Z|medical advice and does not substitute for the advice of your||
2113|006|Z|health care professional. Always ask your health care||
2113|007|Z|professional for complete information about this product and your||
2113|008|Z|specific health needs.||
2113|009|B|||
2113|010|T|METHYL SALICYLATE/MENTHOL PATCH - TOPICAL||
2113|011|F|(METH-il sa-LIS-i-late/MEN-thol)||
2113|012|B|||
2113|013|C|COMMON BRAND NAME(S): Salonpas||
2113|014|B|||
2113|015|U|USES:  This product is used to treat minor aches and pains of the||
2113|016|U|muscles/joints (such as arthritis, backache, sprains). Menthol||
2113|017|U|and methyl salicylate work by causing the skin to feel cool and||
2113|018|U|then warm. These feelings on the skin distract you from feeling||
2113|019|U|the aches/pains deeper in your muscles and joints.||
2113|020|U|   This product should not be used by children younger than 18||
2113|021|U|years without a doctor's advice.||
2113|022|U|   Check the ingredients on the label even if you have used the||
2113|023|U|product before. The manufacturer may have changed the||
2113|024|U|ingredients. Also, products with similar names may contain||
2113|025|U|different ingredients meant for different purposes. Using the||
2113|026|U|wrong product could harm you.||
2113|027|B|||
2113|028|H|HOW TO USE:  Use this medication on the skin only. Clean and dry||
2113|029|H|the affected area. Remove the backing from the patch and apply||
2113|030|H|the patch to the affected area. Do not apply the patch to skin||
2113|031|H|that is injured or irritated (such as skin that is cut, scraped,||
2113|032|H|sunburned, infected, or has a rash). Leave the patch on the||
2113|033|H|affected area for up to 12 hours. Use this medication as directed||
2113|034|H|by your doctor or follow all directions on the product package.||
2113|035|H|If you have any questions, talk to your doctor or pharmacist.||
2113|036|H|   Only use 1 patch at time and do not use more than 2 patches in||
2113|037|H|a 24-hour period.||
2113|038|H|   Do not bandage or wrap the area where the patch is applied||
2113|039|H|unless directed to do so by the doctor.||
2113|040|H|   Heat can increase the risk of side effects. Do not apply this||
2113|041|H|medication immediately before, during, or after activities that||
2113|042|H|increase skin temperature (such as bathing in hot water,||
2113|043|H|swimming, sun bathing, heavy exercise) or in hot/humid weather.||
2113|044|H|Wait until your skin has cooled before applying the medication.||
2113|045|H|Do not use a sunlamp/tanning bed, hot water bottle, or heating||
2113|046|H|pad on the treated area.||
2113|047|H|   Wash your hands well after handling the patch. Avoid getting||
2113|048|H|this medication in your eyes, nose, or mouth. If you do get the||
2113|049|H|medication in those areas, flush with plenty of water.||
2113|050|H|   After removing each patch, fold the used patch with the sticky||
2113|051|H|sides together, and throw away in the trash away from children||
2113|052|H|and pets.||
2113|053|H|   Tell your doctor if your condition lasts for more than 3 days,||
2113|054|H|or if it gets worse, or if it keeps returning. If you think you||
2113|055|H|may have a serious medical problem, get medical help right away.||
2113|056|B|||
2113|057|S|SIDE EFFECTS:  Redness, mild itching, or irritation at the||
2113|058|S|application site may occur. If any of these effects last or get||
2113|059|S|worse, tell your doctor or pharmacist promptly.||
2113|060|S|   If your doctor has directed you to use this medication,||
2113|061|S|remember that your doctor has judged that the benefit to you is||
2113|062|S|greater than the risk of side effects. Many people using this||
2113|063|S|medication do not have serious side effects.||
2113|064|S|   Stop using this product and tell your doctor right away if you||
2113|065|S|have any serious side effects, including: blistering/swelling at||
2113|066|S|the application site, increased/unusual pain at the application||
2113|067|S|site, nausea/vomiting, ringing in the ears.||
2113|068|S|   A very serious allergic reaction to this drug is rare.||
2113|069|S|However, get medical help right away if you notice any symptoms||
2113|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2113|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2113|072|S|breathing.||
2113|073|S|   This is not a complete list of possible side effects. If you||
2113|074|S|notice other effects not listed above, contact your doctor or||
2113|075|S|pharmacist.||
2113|076|S|   In the US -||
2113|077|S|   Call your doctor for medical advice about side effects. You||
2113|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2113|079|S|www.fda.gov/medwatch.||
2113|080|S|   In Canada - Call your doctor for medical advice about side||
2113|081|S|effects. You may report side effects to Health Canada at||
2113|082|S|1-866-234-2345.||
2113|083|B|||
2113|084|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2113|085|P|pharmacist if you are allergic to menthol or methyl salicylate;||
2113|086|P|or to aspirin or other salicylates (such as salsalate); or if you||
2113|087|P|have any other allergies. This product may contain inactive||
2113|088|P|ingredients, which can cause allergic reactions or other||
2113|089|P|problems. Talk to your pharmacist for more details.||
2113|090|P|   Before using this medication, tell your doctor or pharmacist||
2113|091|P|your medical history, especially of: asthma, growths in the nose||
2113|092|P|(nasal polyps).||
2113|093|P|   Before having surgery, tell your doctor or dentist about all||
2113|094|P|the products you use (including prescription drugs,||
2113|095|P|nonprescription drugs, and herbal products).||
2113|096|P|   If you are going to have an MRI test, tell testing personnel||
2113|097|P|if you are using this patch. Some patches may contain metals that||
2113|098|P|can cause serious burns during an MRI. Ask your doctor whether||
2113|099|P|you will need to remove your patch before the test and apply a||
2113|100|P|new patch afterward, and how to do so properly.||
2113|101|P|   This drug contains an aspirin-like product (salicylate).||
2113|102|P|Children and teenagers younger than 18 years should not use this||
2113|103|P|product if they have chickenpox, flu, or any undiagnosed illness||
2113|104|P|or if they have recently received a vaccine. In these cases,||
2113|105|P|using aspirin or aspirin-like products increases the risk of||
2113|106|P|Reye's syndrome, a rare but serious illness.||
2113|107|P|   Tell your doctor if you are pregnant or if you plan to become||
2113|108|P|pregnant. This medication may harm an unborn baby and cause||
2113|109|P|problems with normal labor/delivery. It is not recommended for||
2113|110|P|use in pregnancy from 20 weeks until delivery. If your doctor||
2113|111|P|decides that you need to use this medication between 20 and 30||
2113|112|P|weeks of pregnancy, you should use the lowest effective dose for||
2113|113|P|the shortest possible time. You should not use this medication||
2113|114|P|after 30 weeks of pregnancy. Discuss the risks and benefits with||
2113|115|P|your doctor.||
2113|116|P|   It is unknown if this product passes into breast milk. Consult||
2113|117|P|your doctor before breastfeeding.||
2113|118|B|||
2113|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2113|120|I|medications work or increase your risk for serious side effects.||
2113|121|I|This document does not contain all possible drug interactions.||
2113|122|I|Keep a list of all the products you use (including||
2113|123|I|prescription/nonprescription drugs and herbal products) and share||
2113|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
2113|125|I|the dosage of any medicines without your doctor's approval.||
2113|126|B|||
2113|127|O|OVERDOSE:  This medication patch may be harmful if chewed or||
2113|128|O|swallowed. If someone has overdosed, remove the patch if||
2113|129|O|possible. For serious symptoms such as passing out or trouble||
2113|130|O|breathing, call 911. Otherwise, call a poison control center||
2113|131|O|right away. US residents can call 1-800-222-1222. Canada||
2113|132|O|residents can call 1-844-764-7669.||
2113|133|B|||
2113|134|N|NOTES:  Keep all medical and lab appointments.||
2113|135|B|||
2113|136|D|MISSED DOSE:  If you are using this product on a regular schedule||
2113|137|D|and miss a dose, use it as soon as you remember. If it is near||
2113|138|D|the time of the next dose, skip the missed dose. Use your next||
2113|139|D|dose at the regular time. Do not double the dose to catch up.||
2113|140|B|||
2113|141|R|STORAGE:  Store at room temperature. Keep all medications away||
2113|142|R|from children and pets.||
2113|143|R|   Do not flush medications down the toilet or pour them into a||
2113|144|R|drain unless instructed to do so. Properly discard this product||
2113|145|R|when it is expired or no longer needed. Consult your pharmacist||
2113|146|R|or local waste disposal company.||
2113|147|B|||
2113|148|A|Information last revised February 2025.||
2113|149|A|Copyright(c) 2025 First Databank, Inc.||
2113|150|B|||
2114|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2114|002|Z|does NOT have all possible information about this product. This||
2114|003|Z|information does not assure that this product is safe, effective,||
2114|004|Z|or appropriate for you. This information is not individual||
2114|005|Z|medical advice and does not substitute for the advice of your||
2114|006|Z|health care professional. Always ask your health care||
2114|007|Z|professional for complete information about this product and your||
2114|008|Z|specific health needs.||
2114|009|B|||
2114|010|T|DULOXETINE SPRINKLE CAPSULE - ORAL||
2114|011|F|(doo-LOX-e-teen)||
2114|012|B|||
2114|013|C|COMMON BRAND NAME(S): Drizalma Sprinkle||
2114|014|B|||
2114|015|W|WARNING:  Antidepressant medications are used to treat a variety||
2114|016|W|of conditions, including depression and other mental/mood||
2114|017|W|disorders. These medications can help prevent suicidal||
2114|018|W|thoughts/attempts and provide other important benefits. However,||
2114|019|W|a small number of people (especially people younger than 25) who||
2114|020|W|take antidepressants for any condition may experience worsening||
2114|021|W|depression, other mental/mood symptoms, or suicidal||
2114|022|W|thoughts/attempts. It is very important to talk with the doctor||
2114|023|W|about the risks and benefits of antidepressant medication||
2114|024|W|(especially for people younger than 25), even if treatment is not||
2114|025|W|for a mental/mood condition.||
2114|026|W|   Tell the doctor right away if you notice worsening||
2114|027|W|depression/other psychiatric conditions, unusual behavior changes||
2114|028|W|(including possible suicidal thoughts/attempts), or other||
2114|029|W|mental/mood changes (including new/worsening anxiety, panic||
2114|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2114|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
2114|032|W|especially watchful for these symptoms when a new antidepressant||
2114|033|W|is started or when the dose is changed.||
2114|034|B|||
2114|035|U|USES:  This medication is used to treat certain mental/mood||
2114|036|U|disorders (such as depression, anxiety). It is also used to help||
2114|037|U|relieve nerve pain (peripheral neuropathy) in people with||
2114|038|U|diabetes or ongoing pain due to medical conditions such as||
2114|039|U|arthritis, chronic back pain, or fibromyalgia (a condition that||
2114|040|U|causes widespread pain). Duloxetine belongs to a class of drugs||
2114|041|U|known as serotonin-norepinephrine reuptake inhibitors (SNRIs). It||
2114|042|U|works by helping to restore the balance of certain natural||
2114|043|U|substances (serotonin and norepinephrine) in the brain.||
2114|044|B|||
2114|045|V|OTHER USES:  This section contains uses of this drug that are not||
2114|046|V|listed in the approved professional labeling for the drug but||
2114|047|V|that may be prescribed by your health care professional. Use this||
2114|048|V|drug for a condition that is listed in this section only if it||
2114|049|V|has been so prescribed by your health care professional.||
2114|050|V|   This drug may also be used for other painful nerve conditions||
2114|051|V|(neuropathic pain) or binge eating disorder (BED).||
2114|052|B|||
2114|053|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2114|054|H|Instructions for Use provided by your pharmacist before you start||
2114|055|H|using duloxetine and each time you get a refill. If you have any||
2114|056|H|questions, ask your doctor or pharmacist.||
2114|057|H|   Take this medication by mouth with or without food as directed||
2114|058|H|by your doctor, usually 1 or 2 times a day. If you have nausea,||
2114|059|H|it may help to take this drug with food. You may swallow this||
2114|060|H|medication whole, or you may open the capsule and sprinkle the||
2114|061|H|contents on a tablespoonful of applesauce. Swallow the drug/food||
2114|062|H|mixture right away. Do not crush or chew the mixture. Do not||
2114|063|H|prepare the mixture ahead of time for later use.||
2114|064|H|   The dosage is based on your age, medical condition and||
2114|065|H|response to treatment. To reduce your risk of side effects, your||
2114|066|H|doctor may direct you to start this medication at a low dose and||
2114|067|H|gradually increase your dose. Follow your doctor's instructions||
2114|068|H|carefully. Take this medication regularly to get the most benefit||
2114|069|H|from it. To help you remember, take it at the same time(s) each||
2114|070|H|day.||
2114|071|H|   Keep taking this medication even if you feel well. Do not stop||
2114|072|H|taking this medication without consulting your doctor. Some||
2114|073|H|conditions may become worse when this drug is suddenly stopped.||
2114|074|H|Also, you may experience symptoms such as dizziness, confusion,||
2114|075|H|mood swings, headache, diarrhea, sleep changes, and brief||
2114|076|H|feelings similar to electric shock. To prevent these symptoms||
2114|077|H|while you are stopping treatment with this drug, your doctor may||
2114|078|H|reduce your dose gradually. Consult your doctor or pharmacist for||
2114|079|H|more details. Report any new or worsening symptoms right away.||
2114|080|H|   Tell your doctor if your condition does not get better or if||
2114|081|H|it gets worse.||
2114|082|B|||
2114|083|S|SIDE EFFECTS:  See also Warning section.||
2114|084|S|   Nausea, dry mouth, constipation, loss of appetite, tiredness,||
2114|085|S|drowsiness, or increased sweating may occur. If any of these||
2114|086|S|effects last or get worse, tell your doctor promptly.||
2114|087|S|   Dizziness or lightheadedness may occur, especially when you||
2114|088|S|first start or increase your dose of this drug. To reduce the||
2114|089|S|risk of dizziness, lightheadedness, or falling, get up slowly||
2114|090|S|when rising from a sitting or lying position.||
2114|091|S|   Remember that this medication has been prescribed because your||
2114|092|S|doctor has judged that the benefit to you is greater than the||
2114|093|S|risk of side effects. Many people using this medication do not||
2114|094|S|have serious side effects.||
2114|095|S|   This medication may raise your blood pressure. Check your||
2114|096|S|blood pressure regularly and tell your doctor if the results are||
2114|097|S|high.||
2114|098|S|   Tell your doctor right away if you have any serious side||
2114|099|S|effects, including: confusion, easy bleeding/bruising, decreased||
2114|100|S|interest in sex, changes in sexual ability, muscle||
2114|101|S|cramps/weakness, shaking (tremor), difficulty urinating, signs of||
2114|102|S|liver problems (such as nausea/vomiting that doesn't stop,||
2114|103|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2114|104|S|   Get medical help right away if you have any very serious side||
2114|105|S|effects, including: black stools, vomit that looks like coffee||
2114|106|S|grounds, seizure, eye pain/swelling/redness, widened pupils,||
2114|107|S|vision changes (such as seeing rainbows around lights at night,||
2114|108|S|blurred vision).||
2114|109|S|   This medication may increase serotonin and rarely cause a very||
2114|110|S|serious condition called serotonin syndrome/toxicity. The risk||
2114|111|S|increases if you are also taking other drugs that increase||
2114|112|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2114|113|S|take (see Drug Interactions section). Get medical help right away||
2114|114|S|if you develop some of the following symptoms: fast heartbeat,||
2114|115|S|hallucinations, loss of coordination, severe dizziness, severe||
2114|116|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2114|117|S|unusual agitation/restlessness.||
2114|118|S|   A very serious allergic reaction to this drug is rare.||
2114|119|S|However, get medical help right away if you notice any symptoms||
2114|120|S|of a serious allergic reaction, including: rash, itching/swelling||
2114|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2114|122|S|breathing, skin blisters, mouth sores.||
2114|123|S|   This is not a complete list of possible side effects. If you||
2114|124|S|notice other effects not listed above, contact your doctor or||
2114|125|S|pharmacist.||
2114|126|S|   In the US -||
2114|127|S|   Call your doctor for medical advice about side effects. You||
2114|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2114|129|S|www.fda.gov/medwatch.||
2114|130|S|   In Canada - Call your doctor for medical advice about side||
2114|131|S|effects. You may report side effects to Health Canada at||
2114|132|S|1-866-234-2345.||
2114|133|B|||
2114|134|P|PRECAUTIONS:  Before taking duloxetine, tell your doctor or||
2114|135|P|pharmacist if you are allergic to it; or if you have any other||
2114|136|P|allergies. This product may contain inactive ingredients, which||
2114|137|P|can cause allergic reactions or other problems. Talk to your||
2114|138|P|pharmacist for more details.||
2114|139|P|   Before using this medication, tell your doctor or pharmacist||
2114|140|P|your medical history, especially of: personal or family history||
2114|141|P|of psychiatric disorders (such as bipolar/manic-depressive||
2114|142|P|disorder), personal or family history of suicide attempts,||
2114|143|P|bleeding problems, personal or family history of glaucoma||
2114|144|P|(angle-closure type), high blood pressure, kidney disease, liver||
2114|145|P|disease, seizure disorder, stomach problems (such as slow||
2114|146|P|emptying of the stomach), use/abuse of alcohol.||
2114|147|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2114|148|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2114|149|P|machinery, or do anything that needs alertness until you can do||
2114|150|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2114|151|P|are using marijuana (cannabis).||
2114|152|P|   If you have diabetes, duloxetine may affect your blood sugar.||
2114|153|P|Check your blood sugar regularly as directed and share the||
2114|154|P|results with your doctor. Your doctor may need to adjust your||
2114|155|P|diabetes medication, exercise program, or diet.||
2114|156|P|   Before having surgery, tell your doctor or dentist about all||
2114|157|P|the products you use (including prescription drugs,||
2114|158|P|nonprescription drugs, and herbal products).||
2114|159|P|   Older adults may be more sensitive to the side effects of this||
2114|160|P|drug, especially bleeding, dizziness, lightheadedness, or loss of||
2114|161|P|coordination. Older adults are also more likely to develop a type||
2114|162|P|of mineral imbalance (hyponatremia), especially if they are also||
2114|163|P|taking "water pills" (diuretics) with this medication. Dizziness,||
2114|164|P|lightheadedness, or loss of coordination can increase the risk of||
2114|165|P|falling.||
2114|166|P|   Children may be more sensitive to the side effects of this||
2114|167|P|drug, especially loss of appetite and weight loss. Monitor weight||
2114|168|P|and height in children who are taking this drug. See also Warning||
2114|169|P|section.||
2114|170|P|   During pregnancy, this medication should be used only when||
2114|171|P|clearly needed. This medication may harm an unborn baby. Babies||
2114|172|P|born to mothers who have used this drug during the last 3 months||
2114|173|P|of pregnancy may rarely develop withdrawal symptoms such as||
2114|174|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
2114|175|P|constant crying. If you notice any of these symptoms in your||
2114|176|P|newborn, tell the doctor promptly.||
2114|177|P|   Since untreated mental/mood problems (such as depression,||
2114|178|P|anxiety) can be a serious condition, do not stop taking this||
2114|179|P|medication unless directed by your doctor. If you are planning||
2114|180|P|pregnancy, become pregnant, or think you may be pregnant, discuss||
2114|181|P|with your doctor right away the benefits and risks of using this||
2114|182|P|medication during pregnancy.||
2114|183|P|   This drug passes into breast milk and may have undesirable||
2114|184|P|effects on a nursing infant. Consult your doctor before||
2114|185|P|breastfeeding.||
2114|186|B|||
2114|187|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2114|188|I|medications work or increase your risk for serious side effects.||
2114|189|I|This document does not contain all possible drug interactions.||
2114|190|I|Keep a list of all the products you use (including||
2114|191|I|prescription/nonprescription drugs and herbal products) and share||
2114|192|I|it with your doctor and pharmacist. Do not start, stop, or change||
2114|193|I|the dosage of any medicines without your doctor's approval.||
2114|194|I|   Some products that may interact with this drug are: other||
2114|195|I|drugs that can cause bleeding/bruising (including antiplatelet||
2114|196|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
2114|197|I|"blood thinners" such as dabigatran/warfarin).||
2114|198|I|   Other medications can affect the removal of duloxetine from||
2114|199|I|your body, which may affect how duloxetine works. Examples||
2114|200|I|include cimetidine, fluvoxamine, viloxazine, certain quinolone||
2114|201|I|antibiotics (such as ciprofloxacin, enoxacin), among others.||
2114|202|I|   This medication can slow down the removal of other medications||
2114|203|I|from your body, which may affect how they work. Examples of||
2114|204|I|affected drugs include antiarrhythmic drugs (such as propafenone,||
2114|205|I|flecainide, quinidine), antipsychotics (such as thioridazine),||
2114|206|I|tricyclic antidepressants (such as desipramine, imipramine),||
2114|207|I|among others.||
2114|208|I|   Taking MAO inhibitors with this medication may cause a serious||
2114|209|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2114|210|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2114|211|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2114|212|I|selegiline, tranylcypromine) during treatment with this||
2114|213|I|medication. Most MAO inhibitors should also not be taken for two||
2114|214|I|weeks before and at least 5 days after treatment with this||
2114|215|I|medication. Ask your doctor when to start or stop taking this||
2114|216|I|medication.||
2114|217|I|   The risk of serotonin syndrome/toxicity increases if you are||
2114|218|I|also taking other drugs that increase serotonin. Examples include||
2114|219|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
2114|220|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2114|221|I|other SNRIs such as desvenlafaxine/venlafaxine), tryptophan,||
2114|222|I|among others. The risk of serotonin syndrome/toxicity may be more||
2114|223|I|likely when you start or increase the dose of these drugs.||
2114|224|I|   Tell your doctor or pharmacist if you are using other products||
2114|225|I|that cause drowsiness such as opioid pain or cough relievers||
2114|226|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2114|227|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2114|228|I|zolpidem), muscle relaxants (such as carisoprodol,||
2114|229|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2114|230|I|diphenhydramine).||
2114|231|I|   Check the labels on all your medicines (such as allergy or||
2114|232|I|cough-and-cold products) because they may contain ingredients||
2114|233|I|that cause drowsiness. Ask your pharmacist about using those||
2114|234|I|products safely.||
2114|235|I|   Aspirin can increase the risk of bleeding when used with this||
2114|236|I|medication. However, if your doctor has told you to take low-dose||
2114|237|I|aspirin to prevent heart attack or stroke (usually 81-162||
2114|238|I|milligrams a day), you should keep taking the aspirin unless your||
2114|239|I|doctor tells you not to.||
2114|240|B|||
2114|241|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2114|242|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2114|243|O|poison control center right away. US residents can call||
2114|244|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2114|245|O|Symptoms of overdose may include: severe drowsiness, fainting,||
2114|246|O|seizures, fast heartbeat.||
2114|247|B|||
2114|248|N|NOTES:  Do not share this medication with others.||
2114|249|N|   Lab and/or medical tests (such as blood pressure, liver||
2114|250|N|function) should be done while you are taking this medication.||
2114|251|N|Keep all medical and lab appointments. Consult your doctor for||
2114|252|N|more details.||
2114|253|B|||
2114|254|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2114|255|D|remember. If it is near the time of the next dose, skip the||
2114|256|D|missed dose. Take your next dose at the regular time. Do not||
2114|257|D|double the dose to catch up.||
2114|258|B|||
2114|259|R|STORAGE:  Store at room temperature away from light and moisture.||
2114|260|R|Do not store in the bathroom. Keep all medications away from||
2114|261|R|children and pets.||
2114|262|R|   Do not flush medications down the toilet or pour them into a||
2114|263|R|drain unless instructed to do so. Properly discard this product||
2114|264|R|when it is expired or no longer needed. Consult your pharmacist||
2114|265|R|or local waste disposal company.||
2114|266|B|||
2114|267|A|Information last revised February 2025.||
2114|268|A|Copyright(c) 2025 First Databank, Inc.||
2114|269|B|||
2115|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2115|002|Z|does NOT have all possible information about this product. This||
2115|003|Z|information does not assure that this product is safe, effective,||
2115|004|Z|or appropriate for you. This information is not individual||
2115|005|Z|medical advice and does not substitute for the advice of your||
2115|006|Z|health care professional. Always ask your health care||
2115|007|Z|professional for complete information about this product and your||
2115|008|Z|specific health needs.||
2115|009|B|||
2115|010|T|ESTRADIOL ACETATE RING - VAGINAL||
2115|011|F|(ES-tra-DYE-ol AS-e-tate)||
2115|012|B|||
2115|013|C|COMMON BRAND NAME(S): Femring||
2115|014|B|||
2115|015|W|WARNING:  Estrogens, either used alone or with another hormone||
2115|016|W|(progestin), have rarely caused very serious side effects.||
2115|017|W|Discuss the risks and benefits of hormone treatment with your||
2115|018|W|doctor. Estrogens should not be used to prevent heart disease or||
2115|019|W|dementia.||
2115|020|W|   Estrogens can increase the risk of cancer of the uterus||
2115|021|W|(endometrial cancer). Taking a progestin as directed by your||
2115|022|W|doctor can help decrease this risk. Tell your doctor right away||
2115|023|W|if you have any unusual vaginal bleeding.||
2115|024|W|   In postmenopausal women, estrogens, taken with or without a||
2115|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
2115|026|W|stroke, dementia, and serious blood clots. When used along with a||
2115|027|W|progestin, estrogens also increase the risk of heart disease||
2115|028|W|(such as heart attacks).||
2115|029|W|   The risk for serious side effects may depend on the dose of||
2115|030|W|estrogen and the length of time it is used. This medication||
2115|031|W|should be used at the lowest effective dose and for the shortest||
2115|032|W|amount of time. Discuss the use of this medication with your||
2115|033|W|doctor and check with him/her regularly (for example, every 3 to||
2115|034|W|6 months) to see if you still need to take this medication. If||
2115|035|W|you will be taking this medication long-term, you should have||
2115|036|W|regular complete physical exams (for example, once a year) as||
2115|037|W|directed by your doctor. See also Notes section.||
2115|038|B|||
2115|039|U|USES:  This medication is a hormone (estrogen). It is used by||
2115|040|U|women to help reduce symptoms of menopause (such as hot flashes,||
2115|041|U|vaginal dryness). These symptoms are caused by the body making||
2115|042|U|less estrogen. If you are using this medication to treat symptoms||
2115|043|U|only in and around the vagina, other products applied directly||
2115|044|U|inside the vagina (such as cream, vaginal tablet) should be||
2115|045|U|considered before this product.||
2115|046|B|||
2115|047|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2115|048|H|from your pharmacist before you start using this medication and||
2115|049|H|each time you get a refill. Learn how to use this medication||
2115|050|H|properly. If you have any questions, ask your doctor or||
2115|051|H|pharmacist.||
2115|052|H|   Wash and dry your hands before handling the ring. Insert the||
2115|053|H|ring high into the vagina as directed. The ring is usually left||
2115|054|H|in place for 3 months and then removed and replaced with a new||
2115|055|H|ring if treatment is to be continued. Do not leave a ring in||
2115|056|H|place for longer than 3 months. Follow the dosing schedule||
2115|057|H|carefully.||
2115|058|H|   The dosage is based on your medical condition and response to||
2115|059|H|treatment.||
2115|060|H|   If the ring is put in properly, you should not be able to feel||
2115|061|H|it and it will not interfere with sexual intercourse. If you are||
2115|062|H|able to feel the ring or feel slight discomfort from the ring, it||
2115|063|H|may mean that the ring is not high enough. Gently push the ring||
2115|064|H|higher with your finger.||
2115|065|H|   If the ring falls out of the vagina, rinse the ring with||
2115|066|H|lukewarm water and put it back into the vagina. Contact your||
2115|067|H|doctor if the ring falls out often.||
2115|068|H|   The ring is removed by hooking your finger through the ring||
2115|069|H|and gently pulling it out. Contact your doctor if you have||
2115|070|H|trouble removing the ring. Discard the used ring in the trash. Do||
2115|071|H|not flush it down the toilet.||
2115|072|H|   Tell your doctor if your condition does not get better or if||
2115|073|H|it gets worse.||
2115|074|B|||
2115|075|S|SIDE EFFECTS:  See also Warning section.||
2115|076|S|   Nausea/vomiting, bloating, breast tenderness, headache, or||
2115|077|S|weight changes may occur. If any of these effects last or get||
2115|078|S|worse, tell your doctor or pharmacist promptly.||
2115|079|S|   Remember that this medication has been prescribed because your||
2115|080|S|doctor has judged that the benefit to you is greater than the||
2115|081|S|risk of side effects. Many people using this medication do not||
2115|082|S|have serious side effects.||
2115|083|S|   Tell your doctor right away if you have any serious side||
2115|084|S|effects, including: nausea/vomiting that doesn't stop,||
2115|085|S|mental/mood changes (such as depression, memory loss), breast||
2115|086|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
2115|087|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
2115|088|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
2115|089|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
2115|090|S|increased thirst/urination.||
2115|091|S|   This medication may rarely cause serious (sometimes fatal)||
2115|092|S|problems from blood clots (such as heart attack, stroke, blood||
2115|093|S|clots in the lungs or legs). Get medical help right away if you||
2115|094|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
2115|095|S|headaches, weakness on one side of the body, confusion, trouble||
2115|096|S|speaking, sudden vision changes, pain/swelling/warmth in the||
2115|097|S|groin/calf, shortness of breath/rapid breathing, sudden||
2115|098|S|dizziness/fainting.||
2115|099|S|   Vaginal rings have rarely caused a very serious (possibly||
2115|100|S|fatal) bacterial infection (toxic shock syndrome-TSS). Remove||
2115|101|S|this product and get medical help right away if you have any||
2115|102|S|symptoms of toxic shock syndrome, including: high fever, sudden||
2115|103|S|dizziness/fainting, unusual muscle pain, sunburn-like rash,||
2115|104|S|diarrhea.||
2115|105|S|   A very serious allergic reaction to this product is rare.||
2115|106|S|However, get medical help right away if you notice any symptoms||
2115|107|S|of a serious allergic reaction, including: rash, itching/swelling||
2115|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2115|109|S|breathing.||
2115|110|S|   This is not a complete list of possible side effects. If you||
2115|111|S|notice other effects not listed above, contact your doctor or||
2115|112|S|pharmacist.||
2115|113|S|   In the US -||
2115|114|S|   Call your doctor for medical advice about side effects. You||
2115|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2115|116|S|www.fda.gov/medwatch.||
2115|117|S|   In Canada - Call your doctor for medical advice about side||
2115|118|S|effects. You may report side effects to Health Canada at||
2115|119|S|1-866-234-2345.||
2115|120|B|||
2115|121|P|PRECAUTIONS:  Before using estradiol, tell your doctor or||
2115|122|P|pharmacist if you are allergic to it; or if you have any other||
2115|123|P|allergies. This product may contain inactive ingredients, which||
2115|124|P|can cause allergic reactions or other problems. Talk to your||
2115|125|P|pharmacist for more details.||
2115|126|P|   Before using this medication, tell your doctor or pharmacist||
2115|127|P|your medical history, especially of: vaginal bleeding of unknown||
2115|128|P|cause, certain cancers (such as breast cancer, cancer of the||
2115|129|P|uterus/ovaries), blood clots (such as in the legs, eyes, lungs),||
2115|130|P|blood clotting disorders (such as protein C or protein S||
2115|131|P|deficiency), stroke, heart disease (such as heart attack), liver||
2115|132|P|disease, kidney disease, family medical history (especially||
2115|133|P|breast lumps, cancer, blood clots), family or personal history of||
2115|134|P|a certain swelling disorder (angioedema), blood clotting||
2115|135|P|disorders (such as protein C or protein S deficiency), high blood||
2115|136|P|pressure, diabetes, high cholesterol/triglyceride levels,||
2115|137|P|obesity, lupus, underactive thyroid (hypothyroidism), mineral||
2115|138|P|imbalance (low or high level of calcium in the blood), a certain||
2115|139|P|hormone problem (hypoparathyroidism), uterus problems (such as||
2115|140|P|fibroids, endometriosis), gallbladder disease, asthma, seizures,||
2115|141|P|migraine headaches, mental/mood disorders (such as dementia,||
2115|142|P|depression), a certain blood disorder (porphyria), frequent||
2115|143|P|vaginal infections.||
2115|144|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
2115|145|P|further increases your risk of stroke, blood clots, high blood||
2115|146|P|pressure, and heart attack, especially in women older than 35.||
2115|147|P|   Tell your doctor if you just had or will be having surgery, or||
2115|148|P|if you will be confined to a chair or bed for a long time (such||
2115|149|P|as a long plane flight). These conditions increase your risk of||
2115|150|P|getting blood clots, especially if you are using an estrogen||
2115|151|P|product. You may need to stop this medication for a time or take||
2115|152|P|special precautions.||
2115|153|P|   This medication may cause blotchy, dark areas on your face and||
2115|154|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
2115|155|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
2115|156|P|wear protective clothing when outdoors.||
2115|157|P|   If you are nearsighted or wear contact lenses, you may develop||
2115|158|P|vision problems or trouble wearing your contact lenses. Contact||
2115|159|P|your eye doctor if these problems occur.||
2115|160|P|   If you get a vaginal infection while using this ring, you may||
2115|161|P|leave the ring in place while the infection is being treated.||
2115|162|P|Consult your doctor or pharmacist for treatment options.||
2115|163|P|   This medication should not be used during pregnancy. If you||
2115|164|P|become pregnant or think you may be pregnant, tell your doctor||
2115|165|P|right away.||
2115|166|P|   This medication passes into breast milk. Consult your doctor||
2115|167|P|before breastfeeding.||
2115|168|B|||
2115|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2115|170|I|medications work or increase your risk for serious side effects.||
2115|171|I|This document does not contain all possible drug interactions.||
2115|172|I|Keep a list of all the products you use (including||
2115|173|I|prescription/nonprescription drugs and herbal products) and share||
2115|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
2115|175|I|the dosage of any medicines without your doctor's approval.||
2115|176|I|   Some products that may interact with this drug include:||
2115|177|I|aromatase inhibitors (such as anastrozole, exemestane,||
2115|178|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
2115|179|I|tamoxifen, toremifene, tranexamic acid.||
2115|180|I|   This medication may interfere with certain lab tests, possibly||
2115|181|I|causing false test results. Make sure lab personnel and all your||
2115|182|I|doctors know you use this drug.||
2115|183|B|||
2115|184|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2115|185|O|has overdosed and has serious symptoms such as passing out or||
2115|186|O|trouble breathing, call 911. Otherwise, call a poison control||
2115|187|O|center right away. US residents can call 1-800-222-1222. Canada||
2115|188|O|residents can call 1-844-764-7669. Symptoms of overdose may||
2115|189|O|include: severe nausea/vomiting, unusual vaginal bleeding.||
2115|190|B|||
2115|191|N|NOTES:  Do not share this medication with others.||
2115|192|N|   Regular complete physical exams which include lab and/or||
2115|193|N|medical tests (such as blood pressure, breast exam/mammogram,||
2115|194|N|pelvic exam, Pap smear) should be done while you are using this||
2115|195|N|medication. Follow your doctor's instructions for examining your||
2115|196|N|breasts, and report any lumps right away. Keep all medical and||
2115|197|N|lab appointments. Consult your doctor for more details.||
2115|198|N|   Preventing or controlling high blood pressure, high||
2115|199|N|cholesterol, and diabetes can help to reduce your chances of||
2115|200|N|heart disease and stroke. Lifestyle changes that can help to||
2115|201|N|control or prevent these diseases include reducing stress, eating||
2115|202|N|a low fat/salt diet, losing weight if overweight, exercising||
2115|203|N|regularly, and stopping smoking. Keep your mind active with||
2115|204|N|mental exercises (such as reading, solving crossword puzzles) to||
2115|205|N|help prevent dementia. Talk to your doctor about lifestyle||
2115|206|N|changes that might benefit you.||
2115|207|N|   Lifestyle changes that may help reduce hot flashes include||
2115|208|N|stopping smoking, dressing lightly or in layers,||
2115|209|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
2115|210|N|reducing stress, and exercising regularly.||
2115|211|B|||
2115|212|D|MISSED DOSE:  Not applicable. However, if you have not inserted a||
2115|213|D|new ring after 3 months, ask your doctor or pharmacist right away||
2115|214|D|for a new dosing schedule.||
2115|215|B|||
2115|216|R|STORAGE:  Store at room temperature. Do not remove the ring from||
2115|217|R|the pouch until ready for use. Keep all medications away from||
2115|218|R|children and pets.||
2115|219|R|   Do not flush medications down the toilet or pour them into a||
2115|220|R|drain unless instructed to do so. Properly discard this product||
2115|221|R|when it is expired or no longer needed. Consult your pharmacist||
2115|222|R|or local waste disposal company.||
2115|223|B|||
2115|224|A|Information last revised October 2024.||
2115|225|A|Copyright(c) 2025 First Databank, Inc.||
2115|226|B|||
2117|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2117|002|Z|does NOT have all possible information about this product. This||
2117|003|Z|information does not assure that this product is safe, effective,||
2117|004|Z|or appropriate for you. This information is not individual||
2117|005|Z|medical advice and does not substitute for the advice of your||
2117|006|Z|health care professional. Always ask your health care||
2117|007|Z|professional for complete information about this product and your||
2117|008|Z|specific health needs.||
2117|009|B|||
2117|010|T|MENTHOL/ZINC OXIDE - TOPICAL||
2117|011|F|(MEN-thol/zink OX-ide)||
2117|012|B|||
2117|013|C|COMMON BRAND NAME(S): Caladrox, Calmoseptine, DermaSeptin||
2117|014|B|||
2117|015|U|USES:  This medication is used to treat and prevent minor skin||
2117|016|U|irritations (such as from diarrhea, burns, cuts, scrapes). It||
2117|017|U|works by forming a barrier on the skin to protect it from||
2117|018|U|irritants/moisture.||
2117|019|U|   Check the ingredients on the label even if you have used the||
2117|020|U|product before. The manufacturer may have changed the||
2117|021|U|ingredients. Also, products with similar names may contain||
2117|022|U|different ingredients meant for different purposes. Using the||
2117|023|U|wrong product could harm you.||
2117|024|B|||
2117|025|H|HOW TO USE:  If you are using the over-the-counter product to||
2117|026|H|self-treat, read and follow all directions on the product package||
2117|027|H|before using this medication. If you have any questions, consult||
2117|028|H|your pharmacist. If your doctor has prescribed this medication,||
2117|029|H|use it as directed.||
2117|030|H|   This medication is for use on the skin only. Wash and dry your||
2117|031|H|hands before applying the medication, then clean and dry the||
2117|032|H|affected area. Apply a thin film of the medication to the||
2117|033|H|affected area and gently rub in as directed.||
2117|034|H|   Wash your hands well after applying unless you are using this||
2117|035|H|medication to treat the hands. Avoid getting this medication in||
2117|036|H|your eyes, nose, or mouth. If you do get the medication in those||
2117|037|H|areas, flush with plenty of water.||
2117|038|H|   Tell your doctor if your condition lasts for more than 7 days,||
2117|039|H|or if it gets worse, or if it keeps returning. If you think you||
2117|040|H|may have a serious medical problem, get medical help right away.||
2117|041|B|||
2117|042|S|SIDE EFFECTS:  Redness, warmth, or irritation at the application||
2117|043|S|site may occur. If any of these effects last or get worse, tell||
2117|044|S|your doctor or pharmacist promptly.||
2117|045|S|   If your doctor has directed you to use this medication,||
2117|046|S|remember that your doctor has judged that the benefit to you is||
2117|047|S|greater than the risk of side effects. Many people using this||
2117|048|S|medication do not have serious side effects.||
2117|049|S|   Stop using this medication and tell your doctor right away if||
2117|050|S|you have any serious side effects, including: blistering/swelling||
2117|051|S|at the application site, increased/unusual pain at the||
2117|052|S|application site.||
2117|053|S|   A very serious allergic reaction to this drug is rare.||
2117|054|S|However, get medical help right away if you notice any symptoms||
2117|055|S|of a serious allergic reaction, including: rash, itching/swelling||
2117|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2117|057|S|breathing.||
2117|058|S|   This is not a complete list of possible side effects. If you||
2117|059|S|notice other effects not listed above, contact your doctor or||
2117|060|S|pharmacist.||
2117|061|S|   In the US -||
2117|062|S|   Call your doctor for medical advice about side effects. You||
2117|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2117|064|S|www.fda.gov/medwatch.||
2117|065|S|   In Canada - Call your doctor for medical advice about side||
2117|066|S|effects. You may report side effects to Health Canada at||
2117|067|S|1-866-234-2345.||
2117|068|B|||
2117|069|P|PRECAUTIONS:  Before using menthol/zinc oxide, tell your doctor||
2117|070|P|or pharmacist if you are allergic to menthol; or to zinc oxide;||
2117|071|P|or if you have any other allergies. This product may contain||
2117|072|P|inactive ingredients, which can cause allergic reactions or other||
2117|073|P|problems. Talk to your pharmacist for more details.||
2117|074|P|   Before using this medication, tell your doctor or pharmacist||
2117|075|P|your medical history.||
2117|076|P|   Before having surgery, tell your doctor or dentist about all||
2117|077|P|the products you use (including prescription drugs,||
2117|078|P|nonprescription drugs, and herbal products).||
2117|079|P|   During pregnancy, this medication should be used only when||
2117|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
2117|081|P|   It is unknown if this medication passes into breast milk.||
2117|082|P|Consult your doctor before breastfeeding.||
2117|083|B|||
2117|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2117|085|I|medications work or increase your risk for serious side effects.||
2117|086|I|This document does not contain all possible drug interactions.||
2117|087|I|Keep a list of all the products you use (including||
2117|088|I|prescription/nonprescription drugs and herbal products) and share||
2117|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
2117|090|I|the dosage of any medicines without your doctor's approval.||
2117|091|B|||
2117|092|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2117|093|O|has overdosed and has serious symptoms such as passing out or||
2117|094|O|trouble breathing, call 911. Otherwise, call a poison control||
2117|095|O|center right away. US residents can call 1-800-222-1222. Canada||
2117|096|O|residents can call 1-844-764-7669.||
2117|097|B|||
2117|098|N|NOTES:  Keep all medical and lab appointments.||
2117|099|B|||
2117|100|D|MISSED DOSE:  If you are using this product on a regular schedule||
2117|101|D|and miss a dose, use it as soon as you remember. If it is near||
2117|102|D|the time of the next dose, skip the missed dose. Use your next||
2117|103|D|dose at the regular time. Do not double the dose to catch up.||
2117|104|B|||
2117|105|R|STORAGE:  Refer to storage information printed on the package. If||
2117|106|R|you have any questions about storage, ask your pharmacist. Keep||
2117|107|R|all medications and herbal products away from children and pets.||
2117|108|R|   Do not flush medications down the toilet or pour them into a||
2117|109|R|drain unless instructed to do so. Properly discard this product||
2117|110|R|when it is expired or no longer needed. Consult your pharmacist||
2117|111|R|or local waste disposal company.||
2117|112|B|||
2117|113|A|Information last revised February 2025.||
2117|114|A|Copyright(c) 2025 First Databank, Inc.||
2117|115|B|||
2118|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2118|002|Z|does NOT have all possible information about this product. This||
2118|003|Z|information does not assure that this product is safe, effective,||
2118|004|Z|or appropriate for you. This information is not individual||
2118|005|Z|medical advice and does not substitute for the advice of your||
2118|006|Z|health care professional. Always ask your health care||
2118|007|Z|professional for complete information about this product and your||
2118|008|Z|specific health needs.||
2118|009|B|||
2118|010|T|GUAIFENESIN/PHENYLEPHRINE - ORAL||
2118|011|F|(gweye-FEN-eh-sin/fen-ill-EFF-rin)||
2118|012|B|||
2118|013|C|COMMON BRAND NAME(S): Endal, Numonyl, Sinupan||
2118|014|B|||
2118|015|U|USES:  This combination medication is used to temporarily treat||
2118|016|U|cough and runny/stuffy nose (nasal congestion) caused by||
2118|017|U|infections (such as the common cold), allergies (such as hay||
2118|018|U|fever), and other breathing illnesses. This product is usually||
2118|019|U|not used for ongoing cough from smoking or long-term breathing||
2118|020|U|problems (such as chronic bronchitis, emphysema) unless directed||
2118|021|U|by your doctor. Guaifenesin is an expectorant. It works by||
2118|022|U|thinning and loosening mucus in the airways, clearing congestion,||
2118|023|U|and making breathing easier. Phenylephrine is a decongestant||
2118|024|U|(sympathomimetic). It reduces nasal congestion by narrowing the||
2118|025|U|blood vessels in the nose.||
2118|026|U|   If you are self-treating with this medication, it is important||
2118|027|U|to read the package instructions carefully before you start using||
2118|028|U|this product to be sure it is right for you. (See also||
2118|029|U|Precautions section.)||
2118|030|U|   Cough-and-cold products have not been shown to be safe or||
2118|031|U|effective in children younger than 6 years. Do not use this||
2118|032|U|product to treat cold symptoms in children younger than 6 years||
2118|033|U|unless specifically directed by the doctor. Some products (such||
2118|034|U|as long-acting tablets/capsules) are not recommended for use in||
2118|035|U|children younger than 12 years. Ask your doctor or pharmacist for||
2118|036|U|more details about using your product safely.||
2118|037|U|   These products do not cure or shorten the length of the common||
2118|038|U|cold and may cause serious side effects. To decrease the risk for||
2118|039|U|serious side effects, carefully follow all dosage directions. Do||
2118|040|U|not give other cough-and-cold medication that might contain the||
2118|041|U|same or similar ingredients (see also Drug Interactions section).||
2118|042|U|Ask the doctor or pharmacist about other ways to relieve cough||
2118|043|U|and cold symptoms (such as drinking enough fluids, using a||
2118|044|U|humidifier or saline nose drops/spray).||
2118|045|B|||
2118|046|H|HOW TO USE:  Take this medication by mouth with or without food,||
2118|047|H|as directed by your doctor. If you are self-treating, follow all||
2118|048|H|directions on the product package. To prevent trouble sleeping,||
2118|049|H|do not take this medication close to bedtime. If you have any||
2118|050|H|questions, ask your doctor or pharmacist.||
2118|051|H|   The dosage is based on your age, medical condition, and||
2118|052|H|response to treatment. Do not increase your dose or take this||
2118|053|H|drug more often than directed.||
2118|054|H|   Guaifenesin may have a bitter taste. Swallow capsules and||
2118|055|H|tablets whole. Scored tablets may be split for lower doses.||
2118|056|H|Chewable tablets may be swallowed whole or chewed.||
2118|057|H|   Drink plenty of fluids while taking this medication. Fluids||
2118|058|H|will help to break up mucus and clear congestion.||
2118|059|H|   If you are using the liquid form of this medication, carefully||
2118|060|H|measure the dose using a special measuring device/spoon. Do not||
2118|061|H|use a household spoon because you may not get the correct dose.||
2118|062|H|If your liquid form is a suspension, shake the bottle well before||
2118|063|H|each dose.||
2118|064|H|   Tell your doctor if your condition is accompanied by headache||
2118|065|H|that doesn't go away, fever, severe sore throat, rash, or if it||
2118|066|H|lasts, returns, or gets worse after 7 days. These may be signs of||
2118|067|H|a serious medical problem. Get medical help right away if you||
2118|068|H|think you may have a serious medical problem.||
2118|069|B|||
2118|070|S|SIDE EFFECTS:  Nausea or headache may occur. If either of these||
2118|071|S|effects lasts or gets worse, tell your doctor or pharmacist||
2118|072|S|promptly.||
2118|073|S|   If your doctor has directed you to use this medication,||
2118|074|S|remember that your doctor has judged that the benefit to you is||
2118|075|S|greater than the risk of side effects. Many people using this||
2118|076|S|medication do not have serious side effects.||
2118|077|S|   This medication may raise your blood pressure. Check your||
2118|078|S|blood pressure regularly and tell your doctor if the results are||
2118|079|S|high.||
2118|080|S|   Tell your doctor right away if you have any serious side||
2118|081|S|effects, including: dizziness, fainting, shaking (tremor),||
2118|082|S|fast/irregular/pounding heartbeat, difficult/painful urination,||
2118|083|S|mental/mood changes (such as confusion, nervousness,||
2118|084|S|irritability), trouble sleeping, seizures.||
2118|085|S|   A very serious allergic reaction to this drug is rare.||
2118|086|S|However, get medical help right away if you notice any symptoms||
2118|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2118|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2118|089|S|breathing.||
2118|090|S|   This is not a complete list of possible side effects. If you||
2118|091|S|notice other effects not listed above, contact your doctor or||
2118|092|S|pharmacist.||
2118|093|S|   In the US -||
2118|094|S|   Call your doctor for medical advice about side effects. You||
2118|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2118|096|S|www.fda.gov/medwatch.||
2118|097|S|   In Canada - Call your doctor for medical advice about side||
2118|098|S|effects. You may report side effects to Health Canada at||
2118|099|S|1-866-234-2345.||
2118|100|B|||
2118|101|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2118|102|P|pharmacist if you are allergic to phenylephrine or guaifenesin;||
2118|103|P|or if you have any other allergies. Also tell your doctor if you||
2118|104|P|have had bad reactions to similar drugs (sympathomimetics such as||
2118|105|P|ephedrine). This product may contain inactive ingredients, which||
2118|106|P|can cause allergic reactions or other problems. Talk to your||
2118|107|P|pharmacist for more details.||
2118|108|P|   Before using this medication, tell your doctor or pharmacist||
2118|109|P|your medical history, especially of: breathing problems (such as||
2118|110|P|emphysema, chronic bronchitis, asthma, smoker's cough), cough||
2118|111|P|with blood or large amounts of mucus, high blood pressure, heart||
2118|112|P|disease (such as chest pain, heart failure, heart attack),||
2118|113|P|fast/slow/irregular heartbeat, diabetes, a certain eye problem||
2118|114|P|(glaucoma), difficulty urinating (such as due to enlarged||
2118|115|P|prostate), overactive thyroid (hyperthyroidism).||
2118|116|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2118|117|P|can make you more dizzy. Do not drive, use machinery, or do||
2118|118|P|anything that needs alertness until you can do it safely. Limit||
2118|119|P|alcoholic beverages. Talk to your doctor if you are using||
2118|120|P|marijuana (cannabis).||
2118|121|P|   Before having surgery, tell your doctor or dentist about all||
2118|122|P|the products you use (including prescription drugs,||
2118|123|P|nonprescription drugs, and herbal products).||
2118|124|P|   Liquid forms of this product may contain sugar, aspartame,||
2118|125|P|and/or alcohol. Caution is advised if you have diabetes, liver||
2118|126|P|disease, phenylketonuria (PKU), or any other condition that||
2118|127|P|requires you to limit/avoid these substances in your diet. Ask||
2118|128|P|your doctor or pharmacist about using this product safely.||
2118|129|P|   Children may be more sensitive to the side effects of this||
2118|130|P|drug, especially nervousness, irritability, and high blood||
2118|131|P|pressure.||
2118|132|P|   Older adults may be more sensitive to the side effects of this||
2118|133|P|drug, especially fast/irregular heartbeat, dizziness, problems||
2118|134|P|urinating, trouble sleeping, or confusion.||
2118|135|P|   During pregnancy, this medication should be used only when||
2118|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
2118|137|P|   It is unknown if guaifenesin passes into breast milk.||
2118|138|P|Phenylephrine passes into breast milk. Consult your doctor before||
2118|139|P|breastfeeding.||
2118|140|B|||
2118|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2118|142|I|medications work or increase your risk for serious side effects.||
2118|143|I|This document does not contain all possible drug interactions.||
2118|144|I|Keep a list of all the products you use (including||
2118|145|I|prescription/nonprescription drugs and herbal products) and share||
2118|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
2118|147|I|the dosage of any medicines without your doctor's approval.||
2118|148|I|   Taking MAO inhibitors with this medication may cause a serious||
2118|149|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2118|150|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2118|151|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2118|152|I|selegiline, tranylcypromine) during treatment with this||
2118|153|I|medication. Most MAO inhibitors should also not be taken for two||
2118|154|I|weeks before treatment with this medication. Ask your doctor when||
2118|155|I|to start or stop taking this medication.||
2118|156|I|   Guaifenesin and phenylephrine are available in both||
2118|157|I|prescription and nonprescription products. Check the labels of||
2118|158|I|all your medications to make sure you are not taking more than||
2118|159|I|one product containing guaifenesin or phenylephrine.||
2118|160|I|   Guaifenesin may interfere with certain lab tests (such as||
2118|161|I|urine levels of certain acids), possibly causing false test||
2118|162|I|results. Make sure lab personnel and all your doctors know you||
2118|163|I|use this drug.||
2118|164|B|||
2118|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2118|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2118|167|O|poison control center right away. US residents can call||
2118|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2118|169|O|Symptoms of overdose may include: severe dizziness/fainting, fast||
2118|170|O|irregular heartbeat, slow/fast/shallow breathing, hallucinations,||
2118|171|O|seizures.||
2118|172|B|||
2118|173|N|NOTES:  If your doctor prescribed this medication, do not share||
2118|174|N|this medication with others.||
2118|175|N|   Keep all medical and lab appointments.||
2118|176|B|||
2118|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2118|178|D|remember. If it is near the time of the next dose, skip the||
2118|179|D|missed dose. Take your next dose at the regular time. Do not||
2118|180|D|double the dose to catch up.||
2118|181|B|||
2118|182|R|STORAGE:  Store at room temperature away from light and moisture.||
2118|183|R|Do not store in the bathroom. Do not freeze liquid forms of this||
2118|184|R|medication. Keep all medications away from children and pets.||
2118|185|R|   Do not flush medications down the toilet or pour them into a||
2118|186|R|drain unless instructed to do so. Properly discard this product||
2118|187|R|when it is expired or no longer needed. Consult your pharmacist||
2118|188|R|or local waste disposal company.||
2118|189|B|||
2118|190|A|Information last revised July 2025.||
2118|191|A|Copyright(c) 2025 First Databank, Inc.||
2118|192|B|||
2119|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2119|002|Z|does NOT have all possible information about this product. This||
2119|003|Z|information does not assure that this product is safe, effective,||
2119|004|Z|or appropriate for you. This information is not individual||
2119|005|Z|medical advice and does not substitute for the advice of your||
2119|006|Z|health care professional. Always ask your health care||
2119|007|Z|professional for complete information about this product and your||
2119|008|Z|specific health needs.||
2119|009|B|||
2119|010|T|CALASPARGASE PEGOL - INJECTION||
2119|011|F|(kal-AS-par-jase PEG-ol)||
2119|012|B|||
2119|013|C|COMMON BRAND NAME(S): Asparlas||
2119|014|B|||
2119|015|U|USES:  This medication is used to treat acute lymphoblastic||
2119|016|U|leukemia (ALL). It works by starving tumor cells of certain||
2119|017|U|needed nutrients, which slows or stops the growth of cancer||
2119|018|U|cells.||
2119|019|B|||
2119|020|H|HOW TO USE:  This medication is given by injection into a vein as||
2119|021|H|directed by your doctor, usually once every 21 days. The||
2119|022|H|injection is given by a health care professional, usually over 1||
2119|023|H|hour. The dosage is based on your body size and response to||
2119|024|H|treatment.||
2119|025|H|   To help prevent side effects (infusion and allergic||
2119|026|H|reactions), your doctor may direct you to use other medications||
2119|027|H|before you receive this medication. Use these additional||
2119|028|H|medications exactly as directed by your doctor.||
2119|029|B|||
2119|030|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, or||
2119|031|S|pain/swelling/redness at the injection site may occur. If any of||
2119|032|S|these effects last or get worse, tell your doctor or pharmacist||
2119|033|S|promptly.||
2119|034|S|   Remember that this medication has been prescribed because your||
2119|035|S|doctor has judged that the benefit to you is greater than the||
2119|036|S|risk of side effects. Many people using this medication do not||
2119|037|S|have serious side effects.||
2119|038|S|   Tell your doctor right away if you have any serious side||
2119|039|S|effects, including: severe stomach/abdominal pain, swelling of||
2119|040|S|the stomach/abdomen, signs of liver disease (such as||
2119|041|S|nausea/vomiting that doesn't stop, loss of appetite, yellowing||
2119|042|S|eyes/skin, dark urine), signs of an infection (such as sore||
2119|043|S|throat that doesn't go away, fever, chills), unusual||
2119|044|S|bruising/bleeding (such as nose bleeds, black or bloody stools),||
2119|045|S|signs of high blood sugar (such as increased thirst/urination).||
2119|046|S|   Get medical help right away if you have any very serious side||
2119|047|S|effects, including: shortness of breath/rapid breathing,||
2119|048|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
2119|049|S|dizziness/fainting, pain/swelling/warmth in the arms or legs,||
2119|050|S|sudden/severe headaches, trouble speaking, weakness on one side||
2119|051|S|of the body, sudden vision changes.||
2119|052|S|   A very serious allergic reaction to this drug can occur. Get||
2119|053|S|medical help right away if you notice any symptoms of a serious||
2119|054|S|allergic reaction, including: rash, itching/swelling (especially||
2119|055|S|of the face/tongue/throat), severe dizziness, trouble breathing.||
2119|056|S|   This is not a complete list of possible side effects. If you||
2119|057|S|notice other effects not listed above, contact your doctor or||
2119|058|S|pharmacist.||
2119|059|S|   In the US -||
2119|060|S|   Call your doctor for medical advice about side effects. You||
2119|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2119|062|S|www.fda.gov/medwatch.||
2119|063|S|   In Canada - Call your doctor for medical advice about side||
2119|064|S|effects. You may report side effects to Health Canada at||
2119|065|S|1-866-234-2345.||
2119|066|B|||
2119|067|P|PRECAUTIONS:  Before using calaspargase pegol, tell your doctor||
2119|068|P|or pharmacist if you are allergic to it; or to pegaspargase; or||
2119|069|P|if you have any other allergies. This product may contain||
2119|070|P|inactive ingredients, which can cause allergic reactions or other||
2119|071|P|problems. Talk to your pharmacist for more details.||
2119|072|P|   Before using this medication, tell your doctor or pharmacist||
2119|073|P|your medical history, especially of: history of a serious||
2119|074|P|reaction to L-asparaginase (such as bleeding, blood clots,||
2119|075|P|pancreatitis), diabetes, bleeding/clotting problems, liver||
2119|076|P|disease, pancreatitis.||
2119|077|P|   Tell your health care professional that you are using||
2119|078|P|calaspargase pegol before having any immunizations/vaccinations.||
2119|079|P|Avoid contact with people who have recently received live||
2119|080|P|vaccines (such as flu vaccine inhaled through the nose).||
2119|081|P|   To lower the chance of getting cut, bruised, or injured, use||
2119|082|P|caution with sharp objects like razors and nail cutters, and||
2119|083|P|avoid activities such as contact sports.||
2119|084|P|   Before having surgery, tell your doctor or dentist about all||
2119|085|P|the products you use (including prescription drugs,||
2119|086|P|nonprescription drugs, and herbal products).||
2119|087|P|   Tell your doctor if you are pregnant or plan to become||
2119|088|P|pregnant. You should not become pregnant while using this||
2119|089|P|medication. Calaspargase pegol may harm an unborn baby. Your||
2119|090|P|doctor should order a pregnancy test before you start this||
2119|091|P|medication. Ask about reliable forms of non-hormonal birth||
2119|092|P|control (such as condoms, diaphragm with spermicide) while using||
2119|093|P|this medication and for at least 3 months after the last dose. If||
2119|094|P|you become pregnant, talk to your doctor right away about the||
2119|095|P|risks and benefits of this medication.||
2119|096|P|   It is unknown if this drug passes into breast milk. Because of||
2119|097|P|the possible risk to the infant, breastfeeding is not recommended||
2119|098|P|while using this drug and for at least 3 months after the last||
2119|099|P|dose. Consult your doctor before breastfeeding.||
2119|100|B|||
2119|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2119|102|I|medications work or increase your risk for serious side effects.||
2119|103|I|This document does not contain all possible drug interactions.||
2119|104|I|Keep a list of all the products you use (including||
2119|105|I|prescription/nonprescription drugs and herbal products) and share||
2119|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
2119|107|I|the dosage of any medicines without your doctor's approval.||
2119|108|B|||
2119|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2119|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2119|111|O|poison control center right away. US residents can call||
2119|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2119|113|B|||
2119|114|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2119|115|N|blood clotting tests, liver function, amylase/lipase levels)||
2119|116|N|should be done while you are using this medication. Keep all||
2119|117|N|medical and lab appointments. Consult your doctor for more||
2119|118|N|details.||
2119|119|B|||
2119|120|D|MISSED DOSE:  It is important to get each dose of this medication||
2119|121|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2119|122|D|right away for a new dosing schedule.||
2119|123|B|||
2119|124|R|STORAGE:  Not applicable. This medication is given in a hospital||
2119|125|R|or clinic and will not be stored at home.||
2119|126|B|||
2119|127|M|MEDICAL ALERT:  Your condition can cause complications in a||
2119|128|M|medical emergency. For information about enrolling in MedicAlert,||
2119|129|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2119|130|B|||
2119|131|A|Information last revised April 2025.||
2119|132|A|Copyright(c) 2025 First Databank, Inc.||
2119|133|B|||
2120|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2120|002|Z|does NOT have all possible information about this product. This||
2120|003|Z|information does not assure that this product is safe, effective,||
2120|004|Z|or appropriate for you. This information is not individual||
2120|005|Z|medical advice and does not substitute for the advice of your||
2120|006|Z|health care professional. Always ask your health care||
2120|007|Z|professional for complete information about this product and your||
2120|008|Z|specific health needs.||
2120|009|B|||
2120|010|T|PROGESTERONE GEL - VAGINAL||
2120|011|F|(pro-JESS-ter-own)||
2120|012|B|||
2120|013|C|COMMON BRAND NAME(S): Crinone, Prochieve||
2120|014|B|||
2120|015|U|USES:  This medication is used to treat infertility in women who||
2120|016|U|do not make enough of a certain natural hormone called||
2120|017|U|progesterone. This hormone is needed to maintain pregnancy.||
2120|018|U|   This medication is also used to restore menstrual cycles in||
2120|019|U|women whose cycles have stopped. Progesterone is needed to keep||
2120|020|U|menstrual periods regular.||
2120|021|B|||
2120|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2120|023|H|from your pharmacist before you start using progesterone gel and||
2120|024|H|each time you get a refill. If you have any questions, ask your||
2120|025|H|doctor or pharmacist.||
2120|026|H|   This medication is for vaginal use only. Remove the wrapper||
2120|027|H|and prepare the applicator for use as shown in the instructions.||
2120|028|H|There are additional instructions for preparing the applicator if||
2120|029|H|you use this medication at altitudes above 2,500 feet (762||
2120|030|H|meters).||
2120|031|H|   To treat infertility, use this medication as directed by your||
2120|032|H|doctor, usually once or twice a day. If you become pregnant,||
2120|033|H|continue to use this medication for 10-12 weeks as directed until||
2120|034|H|your body is able to make its own progesterone.||
2120|035|H|   If you are using this medication to restore your menstrual||
2120|036|H|cycle, use it as directed by your doctor, usually every other day||
2120|037|H|up to a total of 6 doses.||
2120|038|H|   If you are directed to use any other vaginal products,||
2120|039|H|separate their application from progesterone gel by at least 6||
2120|040|H|hours.||
2120|041|H|   Use this medication regularly to get the most benefit from it.||
2120|042|H|To help you remember, use it at the same time(s) each day.||
2120|043|H|   Do not increase your dose or use this drug more often or for||
2120|044|H|longer than prescribed. Your condition will not improve any||
2120|045|H|faster, and your risk of side effects will increase.||
2120|046|B|||
2120|047|S|SIDE EFFECTS:  Bloating, cramps, stomach pain, constipation,||
2120|048|S|diarrhea, nausea, breast swelling/pain, pain around the vaginal||
2120|049|S|area, drowsiness, tiredness, decreased interest in sex, joint||
2120|050|S|pain, or headache may occur. If any of these effects last or get||
2120|051|S|worse, tell your doctor or pharmacist promptly.||
2120|052|S|   You may develop a vaginal discharge containing little white||
2120|053|S|balls of gel from using this medication. This is normal and||
2120|054|S|harmless. However, if you develop any unusual vaginal discharge,||
2120|055|S|itching, or odor, tell your doctor or pharmacist promptly.||
2120|056|S|   Remember that this medication has been prescribed because your||
2120|057|S|doctor has judged that the benefit to you is greater than the||
2120|058|S|risk of side effects. Many people using this medication do not||
2120|059|S|have serious side effects.||
2120|060|S|   Tell your doctor right away if you have any serious side||
2120|061|S|effects, including: mental/mood changes (such as depression,||
2120|062|S|nervousness, mood swings), swelling of the hands/feet, increased||
2120|063|S|urination at night, abnormal vaginal bleeding, breast lumps,||
2120|064|S|yellowing eyes/skin.||
2120|065|S|   This medication, especially if used along with an estrogen||
2120|066|S|product, may rarely cause very serious (possibly fatal) problems||
2120|067|S|from blood clots (such as heart attack, stroke, blood clots in||
2120|068|S|the lungs or legs). Get medical help right away if you have:||
2120|069|S|shortness of breath/rapid breathing, chest/jaw/left arm pain,||
2120|070|S|unusual sweating, confusion, sudden dizziness/fainting,||
2120|071|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2120|072|S|trouble speaking, weakness on one side of the body, sudden vision||
2120|073|S|changes.||
2120|074|S|   A very serious allergic reaction to this drug is rare.||
2120|075|S|However, get medical help right away if you notice any symptoms||
2120|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2120|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2120|078|S|breathing.||
2120|079|S|   This is not a complete list of possible side effects. If you||
2120|080|S|notice other effects not listed above, contact your doctor or||
2120|081|S|pharmacist.||
2120|082|S|   In the US -||
2120|083|S|   Call your doctor for medical advice about side effects. You||
2120|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2120|085|S|www.fda.gov/medwatch.||
2120|086|S|   In Canada - Call your doctor for medical advice about side||
2120|087|S|effects. You may report side effects to Health Canada at||
2120|088|S|1-866-234-2345.||
2120|089|B|||
2120|090|P|PRECAUTIONS:  Before using progesterone, tell your doctor or||
2120|091|P|pharmacist if you are allergic to it; or if you have any other||
2120|092|P|allergies. This product may contain inactive ingredients, which||
2120|093|P|can cause allergic reactions or other problems. Talk to your||
2120|094|P|pharmacist for more details.||
2120|095|P|   Before using this medication, tell your doctor or pharmacist||
2120|096|P|your medical history, especially of: vaginal bleeding of unknown||
2120|097|P|cause, personal or family history of cancer (especially breast or||
2120|098|P|cervical cancer), a miscarriage with some tissue remaining in the||
2120|099|P|womb, blood clots, seizures, liver disease, migraines, asthma,||
2120|100|P|heart disease, kidney disease, depression, diabetes.||
2120|101|P|   Before having surgery, tell your doctor or dentist about all||
2120|102|P|the products you use (including prescription drugs,||
2120|103|P|nonprescription drugs, and herbal products).||
2120|104|P|   If you have diabetes, this medication may affect your blood||
2120|105|P|sugar. Check your blood sugar regularly as directed and share the||
2120|106|P|results with your doctor. Tell your doctor right away if you have||
2120|107|P|symptoms of high blood sugar, such as increased thirst/urination.||
2120|108|P|Your doctor may need to adjust your diabetes medication, exercise||
2120|109|P|program, or diet.||
2120|110|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
2120|111|P|can make you more drowsy. Do not drive, use machinery, or do||
2120|112|P|anything that needs alertness until you can do it safely. Limit||
2120|113|P|alcoholic beverages. Talk to your doctor if you are using||
2120|114|P|marijuana (cannabis). In general, alcohol is not recommended for||
2120|115|P|pregnant or possibly pregnant women due to the increased risk of||
2120|116|P|harm to the baby.||
2120|117|P|   This medication may be used in pregnancy as directed by your||
2120|118|P|doctor. Consult your doctor for more details.||
2120|119|P|   This drug passes into breast milk. Consult your doctor before||
2120|120|P|breastfeeding.||
2120|121|B|||
2120|122|I|DRUG INTERACTIONS:  See also How to Use section.||
2120|123|I|   Drug interactions may change how your medications work or||
2120|124|I|increase your risk for serious side effects. This document does||
2120|125|I|not contain all possible drug interactions. Keep a list of all||
2120|126|I|the products you use (including prescription/nonprescription||
2120|127|I|drugs and herbal products) and share it with your doctor and||
2120|128|I|pharmacist. Do not start, stop, or change the dosage of any||
2120|129|I|medicines without your doctor's approval.||
2120|130|B|||
2120|131|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2120|132|O|has overdosed and has serious symptoms such as passing out or||
2120|133|O|trouble breathing, call 911. Otherwise, call a poison control||
2120|134|O|center right away. US residents can call 1-800-222-1222. Canada||
2120|135|O|residents can call 1-844-764-7669.||
2120|136|B|||
2120|137|N|NOTES:  Do not share this medication with others.||
2120|138|N|   You should have regular complete physical exams including||
2120|139|N|blood pressure, breast exam, pelvic exam, and screening for||
2120|140|N|cervical cancer (Pap smear). Follow your doctor's instructions||
2120|141|N|for examining your breasts, and report any lumps right away. Keep||
2120|142|N|all medical and lab appointments. Consult your doctor for more||
2120|143|N|details.||
2120|144|B|||
2120|145|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2120|146|D|If it is near the time of the next dose, skip the missed dose.||
2120|147|D|Use your next dose at the regular time. Do not double the dose to||
2120|148|D|catch up.||
2120|149|B|||
2120|150|R|STORAGE:  Store at room temperature. Keep all medications away||
2120|151|R|from children and pets.||
2120|152|R|   Do not flush medications down the toilet or pour them into a||
2120|153|R|drain unless instructed to do so. Properly discard this product||
2120|154|R|when it is expired or no longer needed. Consult your pharmacist||
2120|155|R|or local waste disposal company.||
2120|156|B|||
2120|157|A|Information last revised May 2025.||
2120|158|A|Copyright(c) 2025 First Databank, Inc.||
2120|159|B|||
2121|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2121|002|Z|does NOT have all possible information about this product. This||
2121|003|Z|information does not assure that this product is safe, effective,||
2121|004|Z|or appropriate for you. This information is not individual||
2121|005|Z|medical advice and does not substitute for the advice of your||
2121|006|Z|health care professional. Always ask your health care||
2121|007|Z|professional for complete information about this product and your||
2121|008|Z|specific health needs.||
2121|009|B|||
2121|010|T|TRIFAROTENE - TOPICAL||
2121|011|F|(trye-FAR-oh-teen)||
2121|012|B|||
2121|013|C|COMMON BRAND NAME(S): Aklief||
2121|014|B|||
2121|015|U|USES:  This medication is used to treat acne. It may decrease the||
2121|016|U|number and severity of acne pimples and speed up healing of||
2121|017|U|pimples that do develop. Trifarotene belongs to a class of||
2121|018|U|medications called retinoids. It works by affecting the growth of||
2121|019|U|cells and decreasing swelling and inflammation.||
2121|020|B|||
2121|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2121|022|H|from your pharmacist before you start using trifarotene and each||
2121|023|H|time you get a refill. If you have any questions, ask your doctor||
2121|024|H|or pharmacist.||
2121|025|H|   Use this medication as directed by your doctor, usually once||
2121|026|H|daily in the evening. Before using, gently clean the affected||
2121|027|H|skin with a mild or soapless cleanser and pat dry.||
2121|028|H|   Wash your hands before and after applying this medication.||
2121|029|H|Apply a small amount of medication in a thin layer on the||
2121|030|H|affected area(s).||
2121|031|H|   Use this medication on the skin only. Avoid getting this||
2121|032|H|medication in your eyes or on your lips. Do not apply to the||
2121|033|H|inner lip area or inside the nose/mouth. If this medication gets||
2121|034|H|in your eyes, flush with large amounts of water. Call your doctor||
2121|035|H|if eye irritation develops. Do not apply to cut, scraped, or||
2121|036|H|sunburned areas, or to skin affected by eczema (a skin||
2121|037|H|condition).||
2121|038|H|   When you begin using this medication, you should also apply a||
2121|039|H|moisturizer on your skin as often as needed to help lessen skin||
2121|040|H|irritation (see also Side Effects section).||
2121|041|H|   Use this medication regularly to get the most benefit from it.||
2121|042|H|To help you remember, use it at the same time each day. Do not||
2121|043|H|use a larger amount or use it more often than directed. Your skin||
2121|044|H|will not improve any faster, and your risk of developing side||
2121|045|H|effects (such as redness, peeling, or pain) will increase.||
2121|046|H|   Tell your doctor if your condition does not get better or if||
2121|047|H|it gets worse.||
2121|048|B|||
2121|049|S|SIDE EFFECTS:  Skin redness, dryness, scaling, itching, or mild||
2121|050|S|stinging/burning commonly occur, especially during the first 4||
2121|051|S|weeks of using this medication. These effects usually lessen with||
2121|052|S|continued use. Apply moisturizer on your skin as often as needed||
2121|053|S|to lessen side effects. If any of these effects lasts or gets||
2121|054|S|worse, tell your doctor or pharmacist promptly. Your doctor may||
2121|055|S|direct you to use trifarotene less often, or temporarily or||
2121|056|S|permanently stop using it.||
2121|057|S|   Remember that this medication has been prescribed because your||
2121|058|S|doctor has judged that the benefit to you is greater than the||
2121|059|S|risk of side effects. Many people using this medication do not||
2121|060|S|have serious side effects.||
2121|061|S|   Tell your doctor right away if you have any serious side||
2121|062|S|effects, including: very red/irritated skin, eye redness and||
2121|063|S|watering (conjunctivitis), eyelid swelling, skin discoloration.||
2121|064|S|   A very serious allergic reaction to this drug is rare.||
2121|065|S|However, get medical help right away if you notice any symptoms||
2121|066|S|of a serious allergic reaction, including: rash, itching/swelling||
2121|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2121|068|S|breathing.||
2121|069|S|   This is not a complete list of possible side effects. If you||
2121|070|S|notice other effects not listed above, contact your doctor or||
2121|071|S|pharmacist.||
2121|072|S|   In the US -||
2121|073|S|   Call your doctor for medical advice about side effects. You||
2121|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2121|075|S|www.fda.gov/medwatch.||
2121|076|S|   In Canada - Call your doctor for medical advice about side||
2121|077|S|effects. You may report side effects to Health Canada at||
2121|078|S|1-866-234-2345.||
2121|079|B|||
2121|080|P|PRECAUTIONS:  Before using trifarotene, tell your doctor or||
2121|081|P|pharmacist if you are allergic to it; or to vitamin A-related||
2121|082|P|drugs (other retinoids such as tretinoin); or if you have any||
2121|083|P|other allergies. This product may contain inactive ingredients,||
2121|084|P|which can cause allergic reactions or other problems. Talk to||
2121|085|P|your pharmacist for more details.||
2121|086|P|   Before using this medication, tell your doctor or pharmacist||
2121|087|P|your medical history, especially of: eczema.||
2121|088|P|   This medication may make you more sensitive to the sun. Limit||
2121|089|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2121|090|P|sunscreen and wear protective clothing when outdoors. Tell your||
2121|091|P|doctor right away if you get sunburned or have skin||
2121|092|P|blisters/redness.||
2121|093|P|   Avoid electrolysis, waxing, and chemical depilatories for hair||
2121|094|P|removal on the treated areas while using this product.||
2121|095|P|   If you have recently used products containing sulfur,||
2121|096|P|resorcinol, or salicylic acid, use trifarotene with caution. Wait||
2121|097|P|until the effects of such products on the skin have decreased||
2121|098|P|before using trifarotene.||
2121|099|P|   Before having surgery, tell your doctor or dentist about all||
2121|100|P|the products you use (including prescription drugs,||
2121|101|P|nonprescription drugs, and herbal products).||
2121|102|P|   During pregnancy, this medication should be used only when||
2121|103|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2121|104|P|benefits with your doctor.||
2121|105|P|   It is unknown if this drug passes into breast milk. Consult||
2121|106|P|your doctor before breastfeeding.||
2121|107|B|||
2121|108|I|DRUG INTERACTIONS:  See also Precautions section.||
2121|109|I|   Drug interactions may change how your medications work or||
2121|110|I|increase your risk for serious side effects. This document does||
2121|111|I|not contain all possible drug interactions. Keep a list of all||
2121|112|I|the products you use (including prescription/nonprescription||
2121|113|I|drugs and herbal products) and share it with your doctor and||
2121|114|I|pharmacist. Do not start, stop, or change the dosage of any||
2121|115|I|medicines without your doctor's approval.||
2121|116|I|   Avoid using other skin products that are harsh, irritating, or||
2121|117|I|drying on the treated area. These products include hair perming||
2121|118|I|solutions, alcohol/lime/menthol-containing products (such as||
2121|119|I|astringents, toners, shaving lotion), medicated or abrasive soaps||
2121|120|I|or cleansers, soaps and cosmetics with a strong drying effect||
2121|121|I|(such as alpha hydroxy acids, glycolic acid), and products||
2121|122|I|containing sulfur, resorcinol, or salicylic acid.||
2121|123|B|||
2121|124|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2121|125|O|has overdosed and has serious symptoms such as passing out or||
2121|126|O|trouble breathing, call 911. Otherwise, call a poison control||
2121|127|O|center right away. US residents can call 1-800-222-1222. Canada||
2121|128|O|residents can call 1-844-764-7669.||
2121|129|B|||
2121|130|N|NOTES:  Do not share this medication with others.||
2121|131|N|   Cosmetics may be used, but clean skin thoroughly before||
2121|132|N|applying the medication.||
2121|133|N|   Some cosmetics and soaps may worsen your acne. When buying||
2121|134|N|cosmetics, moisturizers or other skin care products, check the||
2121|135|N|label for "non-comedogenic" or "non-acnegenic." These products||
2121|136|N|are unlikely to worsen your acne. Ask your doctor or pharmacist||
2121|137|N|which products are safe to use. Remember, acne is not caused by||
2121|138|N|dirt. Cleaning your skin too hard or too often can irritate your||
2121|139|N|skin and make acne worse.||
2121|140|B|||
2121|141|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2121|142|D|If you don't remember until the next day, skip the missed dose.||
2121|143|D|Use your next dose at the regular time. Do not double the dose to||
2121|144|D|catch up.||
2121|145|B|||
2121|146|R|STORAGE:  Store at room temperature. Keep all medications away||
2121|147|R|from children and pets.||
2121|148|R|   Do not flush medications down the toilet or pour them into a||
2121|149|R|drain unless instructed to do so. Properly discard this product||
2121|150|R|when it is expired or no longer needed. Consult your pharmacist||
2121|151|R|or local waste disposal company.||
2121|152|B|||
2121|153|A|Information last revised October 2024.||
2121|154|A|Copyright(c) 2025 First Databank, Inc.||
2121|155|B|||
2122|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2122|002|Z|does NOT have all possible information about this product. This||
2122|003|Z|information does not assure that this product is safe, effective,||
2122|004|Z|or appropriate for you. This information is not individual||
2122|005|Z|medical advice and does not substitute for the advice of your||
2122|006|Z|health care professional. Always ask your health care||
2122|007|Z|professional for complete information about this product and your||
2122|008|Z|specific health needs.||
2122|009|B|||
2122|010|T|DIBUCAINE - TOPICAL||
2122|011|F|(DYE-bue-kane)||
2122|012|B|||
2122|013|U|USES:  This medication is used on the skin to stop itching and||
2122|014|U|pain from certain skin conditions (such as scrapes, minor burns,||
2122|015|U|eczema, insect bites) and to treat minor discomfort and itching||
2122|016|U|caused by hemorrhoids. Dibucaine is a local anesthetic that works||
2122|017|U|by causing temporary numbness/loss of feeling in the skin.||
2122|018|B|||
2122|019|H|HOW TO USE:  If you are using the over-the-counter product to||
2122|020|H|self-treat, read all directions on the product package before||
2122|021|H|using this medication. If you have any questions, consult your||
2122|022|H|pharmacist. If your doctor has prescribed this medication, use it||
2122|023|H|as directed.||
2122|024|H|   Before use on the skin, clean and dry the affected area as||
2122|025|H|directed. Apply a thin layer of medication to the affected area||
2122|026|H|of skin as directed, usually 3 to 4 times a day.||
2122|027|H|   Do not use on large areas of the body or apply heat unless||
2122|028|H|directed to do so by your doctor. These may increase the risk of||
2122|029|H|serious side effects.||
2122|030|H|   Wash hands immediately after use unless you are treating an||
2122|031|H|area on the hands. Avoid getting the product in eyes, nose, or||
2122|032|H|ears. If the medication gets in these areas, rinse the area||
2122|033|H|immediately with clean water.||
2122|034|H|   The dosage is based on your medical condition and response to||
2122|035|H|treatment. Do not use more of this product, use it more often, or||
2122|036|H|keep using it longer than directed. If there is an infection or||
2122|037|H|sore in the area to be treated, do not use this medication||
2122|038|H|without consulting your doctor first.||
2122|039|H|   If your condition lasts or gets worse, or if you think you may||
2122|040|H|have a serious medical problem, get medical help right away.||
2122|041|B|||
2122|042|S|SIDE EFFECTS:  Temporary redness, stinging, and a little bit of||
2122|043|S|swelling may occur at the application site. If any of these||
2122|044|S|effects last or get worse, tell your doctor or pharmacist||
2122|045|S|promptly.||
2122|046|S|   If your doctor has directed you to use this medication,||
2122|047|S|remember that your doctor has judged that the benefit to you is||
2122|048|S|greater than the risk of side effects. Many people using this||
2122|049|S|medication do not have serious side effects.||
2122|050|S|   Get medical help right away if you have any very serious side||
2122|051|S|effects, including: slow/shallow breathing, seizures,||
2122|052|S|pale/bluish/gray skin, unusual tiredness, shortness of breath,||
2122|053|S|fast/slow/irregular heartbeat.||
2122|054|S|   A very serious allergic reaction to this drug is rare.||
2122|055|S|However, get medical help right away if you notice any symptoms||
2122|056|S|of a serious allergic reaction, including: rash, itching/swelling||
2122|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2122|058|S|breathing.||
2122|059|S|   This is not a complete list of possible side effects. If you||
2122|060|S|notice any other effects not listed above, contact your doctor or||
2122|061|S|pharmacist.||
2122|062|S|   In the US -||
2122|063|S|   Call your doctor for medical advice about side effects. You||
2122|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2122|065|S|www.fda.gov/medwatch.||
2122|066|S|   In Canada - Call your doctor for medical advice about side||
2122|067|S|effects. You may report side effects to Health Canada at||
2122|068|S|1-866-234-2345.||
2122|069|B|||
2122|070|P|PRECAUTIONS:  Before using dibucaine, tell your doctor or||
2122|071|P|pharmacist if you are allergic to it; or to other amide-type||
2122|072|P|anesthetics (such as lidocaine, prilocaine); or if you have any||
2122|073|P|other allergies. This product may contain inactive ingredients,||
2122|074|P|which can cause allergic reactions or other problems. Talk to||
2122|075|P|your pharmacist for more details.||
2122|076|P|   Before using this medication, tell your doctor or pharmacist||
2122|077|P|your medical history, especially of: broken skin/infection in the||
2122|078|P|area where dibucaine is to be used, heart disease, liver disease,||
2122|079|P|a certain blood disorder (methemoglobinemia).||
2122|080|P|   Before having surgery, tell your doctor or dentist about all||
2122|081|P|the products you use (including prescription drugs,||
2122|082|P|nonprescription drugs, and herbal products).||
2122|083|P|   During pregnancy, this medication should be used only when||
2122|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
2122|085|P|   It is unknown if this medication passes into breast milk.||
2122|086|P|Consult your doctor before breastfeeding.||
2122|087|B|||
2122|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2122|089|I|medications work or increase your risk for serious side effects.||
2122|090|I|This document does not contain all possible drug interactions.||
2122|091|I|Keep a list of all the products you use (including||
2122|092|I|prescription/nonprescription drugs and herbal products) and share||
2122|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
2122|094|I|the dosage of any medicines without your doctor's approval.||
2122|095|B|||
2122|096|O|OVERDOSE:  This medicine may be harmful if inhaled or swallowed.||
2122|097|O|If someone has overdosed and has serious symptoms such as passing||
2122|098|O|out or trouble breathing, call 911. Otherwise, call a poison||
2122|099|O|control center right away. US residents can call 1-800-222-1222.||
2122|100|O|Canada residents can call 1-844-764-7669. Symptoms of overdose||
2122|101|O|may include: drowsiness, irregular heartbeat, seizures.||
2122|102|B|||
2122|103|N|NOTES:  Keep all medical and lab appointments.||
2122|104|B|||
2122|105|D|MISSED DOSE:  If you are using this product on a regular schedule||
2122|106|D|and miss a dose, use it as soon as you remember. If it is near||
2122|107|D|the time of the next dose, skip the missed dose. Use your next||
2122|108|D|dose at the regular time. Do not double the dose to catch up.||
2122|109|B|||
2122|110|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
2122|111|R|medications away from children and pets.||
2122|112|R|   Do not flush medications down the toilet or pour them into a||
2122|113|R|drain unless instructed to do so. Properly discard this product||
2122|114|R|when it is expired or no longer needed. Consult your pharmacist||
2122|115|R|or local waste disposal company.||
2122|116|B|||
2122|117|A|Information last revised February 2025.||
2122|118|A|Copyright(c) 2025 First Databank, Inc.||
2122|119|B|||
2123|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2123|002|Z|does NOT have all possible information about this product. This||
2123|003|Z|information does not assure that this product is safe, effective,||
2123|004|Z|or appropriate for you. This information is not individual||
2123|005|Z|medical advice and does not substitute for the advice of your||
2123|006|Z|health care professional. Always ask your health care||
2123|007|Z|professional for complete information about this product and your||
2123|008|Z|specific health needs.||
2123|009|B|||
2123|010|T|CALCIUM CARBONATE ANTACID - ORAL||
2123|011|F|(KAL-see-um KAR-bo-nate)||
2123|012|B|||
2123|013|C|COMMON BRAND NAME(S): Rolaids, Titralac, Tums||
2123|014|B|||
2123|015|U|USES:  This medication is used to treat symptoms caused by too||
2123|016|U|much stomach acid such as heartburn, upset stomach, or||
2123|017|U|indigestion. It is an antacid that works by lowering the amount||
2123|018|U|of acid in the stomach.||
2123|019|U|   Check the ingredients on the label even if you have used the||
2123|020|U|product before. The manufacturer may have changed the||
2123|021|U|ingredients. Also, products with similar names may contain||
2123|022|U|different ingredients meant for different purposes. Taking the||
2123|023|U|wrong product could harm you.||
2123|024|B|||
2123|025|V|OTHER USES:  This section contains uses of this drug that are not||
2123|026|V|listed in the approved professional labeling for the drug but||
2123|027|V|that may be prescribed by your health care professional. Use this||
2123|028|V|drug for a condition that is listed in this section only if it||
2123|029|V|has been so prescribed by your health care professional.||
2123|030|V|   This drug may also be used for low blood calcium levels in||
2123|031|V|people who do not get enough calcium from their diets.||
2123|032|B|||
2123|033|H|HOW TO USE:  Take this product by mouth as directed. For the||
2123|034|H|chewable form, chew the medication well before swallowing. For||
2123|035|H|the liquid form, shake the bottle well before each dose. Follow||
2123|036|H|all directions on the product package. Do not take more than the||
2123|037|H|maximum recommended dose stated on the product package. If you||
2123|038|H|have any questions, ask your doctor or pharmacist.||
2123|039|H|   Tell your doctor if your condition lasts or gets worse. Do not||
2123|040|H|take the maximum dose of the medication for more than 2 weeks||
2123|041|H|unless directed by your doctor. If you think you may have a||
2123|042|H|serious medical problem, get medical help right away.||
2123|043|B|||
2123|044|S|SIDE EFFECTS:  Constipation, gas, and burping may occur. If any||
2123|045|S|of these effects last or get worse, tell your doctor or||
2123|046|S|pharmacist promptly.||
2123|047|S|   If your doctor has directed you to use this medication,||
2123|048|S|remember that your doctor has judged that the benefit to you is||
2123|049|S|greater than the risk of side effects. Many people using this||
2123|050|S|medication do not have serious side effects.||
2123|051|S|   Tell your doctor right away if you have any serious side||
2123|052|S|effects, including: loss of appetite, nausea/vomiting, unusual||
2123|053|S|weight loss, bone/muscle pain, mental/mood changes (such as||
2123|054|S|confusion), headache, increased thirst/urination, unusual||
2123|055|S|weakness/tiredness, signs of kidney problems (such as change in||
2123|056|S|the amount of urine).||
2123|057|S|   A very serious allergic reaction to this drug is rare.||
2123|058|S|However, get medical help right away if you notice any symptoms||
2123|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2123|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2123|061|S|breathing.||
2123|062|S|   This is not a complete list of possible side effects. If you||
2123|063|S|notice other effects not listed above, contact your doctor or||
2123|064|S|pharmacist.||
2123|065|S|   In the US -||
2123|066|S|   Call your doctor for medical advice about side effects. You||
2123|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2123|068|S|www.fda.gov/medwatch.||
2123|069|S|   In Canada - Call your doctor for medical advice about side||
2123|070|S|effects. You may report side effects to Health Canada at||
2123|071|S|1-866-234-2345.||
2123|072|B|||
2123|073|P|PRECAUTIONS:  Before taking calcium carbonate, tell your doctor||
2123|074|P|or pharmacist if you are allergic to it; or if you have any other||
2123|075|P|allergies. This product may contain inactive ingredients (such as||
2123|076|P|milk or dairy products found in some brands), which can cause||
2123|077|P|allergic reactions or other problems. Talk to your pharmacist for||
2123|078|P|more details.||
2123|079|P|   If you have any of the following health problems, consult your||
2123|080|P|doctor or pharmacist before using this medication: high calcium||
2123|081|P|levels (hypercalcemia), stomach/intestinal blockage, kidney||
2123|082|P|disease (such as kidney stones).||
2123|083|P|   Some products may contain aspartame. If you have||
2123|084|P|phenylketonuria (PKU) or any other condition that requires you to||
2123|085|P|restrict your intake of aspartame (or phenylalanine), consult||
2123|086|P|your doctor or pharmacist about using this drug safely.||
2123|087|P|   Before having surgery, tell your doctor or dentist about all||
2123|088|P|the products you use (including prescription drugs,||
2123|089|P|nonprescription drugs, and herbal products).||
2123|090|P|   Tell your doctor if you are pregnant before using this||
2123|091|P|medication.||
2123|092|P|   This medication passes into breast milk. Consult your doctor||
2123|093|P|before breastfeeding.||
2123|094|B|||
2123|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2123|096|I|medications work or increase your risk for serious side effects.||
2123|097|I|This document does not contain all possible drug interactions.||
2123|098|I|Keep a list of all the products you use (including||
2123|099|I|prescription/nonprescription drugs and herbal products) and share||
2123|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
2123|101|I|the dosage of any medicines without your doctor's approval.||
2123|102|I|   Antacids can interfere with the absorption of many other||
2123|103|I|drugs. Be sure to check with your pharmacist before taking||
2123|104|I|antacids with any other medication.||
2123|105|I|   Check the labels on all your prescription and||
2123|106|I|nonprescription/herbal products (such as supplements, vitamins)||
2123|107|I|because they may contain calcium. Ask your pharmacist about using||
2123|108|I|those products safely.||
2123|109|B|||
2123|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2123|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2123|112|O|poison control center right away. US residents can call||
2123|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2123|114|O|Symptoms of overdose may include: nausea/vomiting, loss of||
2123|115|O|appetite, mental/mood changes, headache, weakness, dizziness.||
2123|116|B|||
2123|117|N|NOTES:  Keep all medical and lab appointments.||
2123|118|N|   Lifestyle changes such as stress reduction programs, stopping||
2123|119|N|smoking, limiting alcohol, and diet changes (such as avoiding||
2123|120|N|caffeine/certain spices) may help to reduce heartburn and other||
2123|121|N|stomach acid problems. Talk to your doctor or pharmacist about||
2123|122|N|lifestyle changes that might benefit you.||
2123|123|B|||
2123|124|D|MISSED DOSE:  Not applicable.||
2123|125|B|||
2123|126|R|STORAGE:  Store at room temperature away from light and moisture.||
2123|127|R|Do not store in the bathroom. Keep all medications away from||
2123|128|R|children and pets.||
2123|129|R|   Do not flush medications down the toilet or pour them into a||
2123|130|R|drain unless instructed to do so. Properly discard this product||
2123|131|R|when it is expired or no longer needed. Consult your pharmacist||
2123|132|R|or local waste disposal company.||
2123|133|B|||
2123|134|A|Information last revised October 2025.||
2123|135|A|Copyright(c) 2025 First Databank, Inc.||
2123|136|B|||
2124|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2124|002|Z|does NOT have all possible information about this product. This||
2124|003|Z|information does not assure that this product is safe, effective,||
2124|004|Z|or appropriate for you. This information is not individual||
2124|005|Z|medical advice and does not substitute for the advice of your||
2124|006|Z|health care professional. Always ask your health care||
2124|007|Z|professional for complete information about this product and your||
2124|008|Z|specific health needs.||
2124|009|B|||
2124|010|T|GLUCOSE - ORAL||
2124|011|F|(GLOO-kose)||
2124|012|B|||
2124|013|C|COMMON BRAND NAME(S): Dex4, Glutose-5, Trueplus||
2124|014|B|||
2124|015|U|USES:  This product is used to treat low blood sugar levels.||
2124|016|U|Symptoms of low blood sugar include sudden sweating, cold skin,||
2124|017|U|shaking, irritability, fast heartbeat, hunger, blurred vision,||
2124|018|U|dizziness, or tingling hands/feet. It is a good habit to carry||
2124|019|U|glucose tablets, liquid, or gel to treat low blood sugar.||
2124|020|U|   If you don't have these reliable forms of glucose, rapidly||
2124|021|U|raise your blood sugar by eating a quick source of sugar such as||
2124|022|U|table sugar, honey, or candy, or drink fruit juice or non-diet||
2124|023|U|soda. To help prevent low blood sugar, eat meals on a regular||
2124|024|U|schedule, and do not skip meals. Check with your doctor or||
2124|025|U|pharmacist about what to do if you miss a meal.||
2124|026|B|||
2124|027|H|HOW TO USE:  Read and follow all directions on the product||
2124|028|H|package before you need to take this product. Be sure to keep||
2124|029|H|this product handy in case it is needed. If you have any||
2124|030|H|questions, consult your doctor or pharmacist.||
2124|031|H|   Take this product by mouth as directed. If you are taking a||
2124|032|H|chewable form of this product, chew it thoroughly before||
2124|033|H|swallowing. Some liquid forms need to be shaken before use. Check||
2124|034|H|the manufacturer's directions.||
2124|035|H|   Check your blood sugar level 10 to 15 minutes after taking||
2124|036|H|this product. If your blood sugar level is still low, take||
2124|037|H|another dose. The blood sugar level should be kept up by eating||
2124|038|H|snacks such as crackers, cheese, a meat sandwich, or milk.||
2124|039|H|   If your symptoms do not get better within 20 minutes or if||
2124|040|H|they get worse, or if you think you may have a serious medical||
2124|041|H|problem, get medical help right away.||
2124|042|B|||
2124|043|S|SIDE EFFECTS:  This product usually has very few side effects. If||
2124|044|S|you have any unusual effects from taking this product, tell your||
2124|045|S|doctor or pharmacist promptly.||
2124|046|S|   If your doctor has directed you to use this product, remember||
2124|047|S|that your doctor has judged that the benefit to you is greater||
2124|048|S|than the risk of side effects. Many people using this product do||
2124|049|S|not have serious side effects.||
2124|050|S|   A very serious allergic reaction to this drug is rare.||
2124|051|S|However, get medical help right away if you notice any symptoms||
2124|052|S|of a serious allergic reaction, including: rash, itching/swelling||
2124|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2124|054|S|breathing.||
2124|055|S|   This is not a complete list of possible side effects. If you||
2124|056|S|notice other effects not listed above, contact your doctor or||
2124|057|S|pharmacist.||
2124|058|S|   In the US -||
2124|059|S|   Call your doctor for medical advice about side effects. You||
2124|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2124|061|S|www.fda.gov/medwatch.||
2124|062|S|   In Canada - Call your doctor for medical advice about side||
2124|063|S|effects. You may report side effects to Health Canada at||
2124|064|S|1-866-234-2345.||
2124|065|B|||
2124|066|P|PRECAUTIONS:  Before taking glucose, tell your doctor or||
2124|067|P|pharmacist if you are allergic to it; or if you have any other||
2124|068|P|allergies. This product may contain inactive ingredients, which||
2124|069|P|can cause allergic reactions or other problems. Talk to your||
2124|070|P|pharmacist for more details.||
2124|071|P|   Before having surgery, tell your doctor or dentist about all||
2124|072|P|the products you use (including prescription drugs,||
2124|073|P|nonprescription drugs, and herbal products).||
2124|074|P|   This product is safe to take during pregnancy when used as||
2124|075|P|directed.||
2124|076|P|   It is unknown if this product passes into breast milk. Consult||
2124|077|P|your doctor before breastfeeding.||
2124|078|B|||
2124|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2124|080|I|medications work or increase your risk for serious side effects.||
2124|081|I|This document does not contain all possible drug interactions.||
2124|082|I|Keep a list of all the products you use (including||
2124|083|I|prescription/nonprescription drugs and herbal products) and share||
2124|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
2124|085|I|the dosage of any medicines without your doctor's approval.||
2124|086|B|||
2124|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2124|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2124|089|O|poison control center right away. US residents can call||
2124|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2124|091|B|||
2124|092|N|NOTES:  Keep all medical and lab appointments.||
2124|093|N|   Attend a diabetes education program to learn more about how to||
2124|094|N|manage your diabetes with medications, diet, exercise, and||
2124|095|N|regular medical exams.||
2124|096|B|||
2124|097|D|MISSED DOSE:  Not applicable.||
2124|098|B|||
2124|099|R|STORAGE:  Store at room temperature away from light and moisture.||
2124|100|R|Do not store in the bathroom. Do not freeze liquid forms of this||
2124|101|R|medication. Different brands of this medication have different||
2124|102|R|storage needs. Check the product package for instructions on how||
2124|103|R|to store your brand, or ask your pharmacist. Keep all medications||
2124|104|R|away from children and pets.||
2124|105|R|   Do not flush medications down the toilet or pour them into a||
2124|106|R|drain unless instructed to do so. Properly discard this product||
2124|107|R|when it is expired or no longer needed. Consult your pharmacist||
2124|108|R|or local waste disposal company.||
2124|109|B|||
2124|110|M|MEDICAL ALERT:  Your condition can cause complications in a||
2124|111|M|medical emergency. For information about enrolling in MedicAlert,||
2124|112|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2124|113|B|||
2124|114|A|Information last revised February 2025.||
2124|115|A|Copyright(c) 2025 First Databank, Inc.||
2124|116|B|||
2125|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2125|002|Z|does NOT have all possible information about this product. This||
2125|003|Z|information does not assure that this product is safe, effective,||
2125|004|Z|or appropriate for you. This information is not individual||
2125|005|Z|medical advice and does not substitute for the advice of your||
2125|006|Z|health care professional. Always ask your health care||
2125|007|Z|professional for complete information about this product and your||
2125|008|Z|specific health needs.||
2125|009|B|||
2125|010|T|FUSIDIC ACID, FUSIDATE SODIUM - TOPICAL||
2125|011|F|(fyou-SID-ick AS-id, FYOU-seh-date SO-dee-um)||
2125|012|B|||
2125|013|U|USES:  This medication is used to treat skin infections. It is an||
2125|014|U|antibiotic that works by stopping the growth of certain bacteria.||
2125|015|B|||
2125|016|H|HOW TO USE:  If you are using this medication on the skin, clean||
2125|017|H|and dry the affected area as directed. Then apply a thin film of||
2125|018|H|medication to the affected area as directed by your doctor,||
2125|019|H|usually 3 to 4 times a day. Cover with a bandage if your doctor||
2125|020|H|directs you to do so.||
2125|021|H|   Do not use large amounts of this medication, apply it more||
2125|022|H|often, or use it for longer than directed. Your condition will||
2125|023|H|not clear faster, but the chance for side effects may be||
2125|024|H|increased.||
2125|025|H|   Avoid using this medication in or around your eyes, unless||
2125|026|H|otherwise directed by your doctor.||
2125|027|H|   Use this medication regularly to get the most benefit from it.||
2125|028|H|Continue to use this medication for the full time prescribed,||
2125|029|H|even if symptoms disappear after a few days. Stopping the||
2125|030|H|medication too early may result in a return of the infection.||
2125|031|H|   Tell your doctor if your condition lasts or gets worse.||
2125|032|B|||
2125|033|S|SIDE EFFECTS:  Mild irritation, burning, redness, or pain may||
2125|034|S|occur. If any of these effects last or get worse, tell your||
2125|035|S|doctor or pharmacist promptly.||
2125|036|S|   Remember that this medication has been prescribed because your||
2125|037|S|doctor has judged that the benefit to you is greater than the||
2125|038|S|risk of side effects. Many people using this medication do not||
2125|039|S|have serious side effects.||
2125|040|S|   Use of this medication for prolonged or repeated periods may||
2125|041|S|result in a new infection (such as a fungal infection). Contact||
2125|042|S|your doctor if you notice signs of a new infection.||
2125|043|S|   A very serious allergic reaction to this drug is rare.||
2125|044|S|However, get medical help right away if you notice any symptoms||
2125|045|S|of a serious allergic reaction, including: rash, itching/swelling||
2125|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2125|047|S|breathing.||
2125|048|S|   This is not a complete list of possible side effects. If you||
2125|049|S|notice other effects not listed above, contact your doctor or||
2125|050|S|pharmacist.||
2125|051|S|   In the US -||
2125|052|S|   Call your doctor for medical advice about side effects. You||
2125|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2125|054|S|www.fda.gov/medwatch.||
2125|055|S|   In Canada - Call your doctor for medical advice about side||
2125|056|S|effects. You may report side effects to Health Canada at||
2125|057|S|1-866-234-2345.||
2125|058|B|||
2125|059|P|PRECAUTIONS:  Before using fusidic acid or fusidate sodium, tell||
2125|060|P|your doctor or pharmacist if you are allergic to it; or if you||
2125|061|P|have any other allergies. This product may contain inactive||
2125|062|P|ingredients (such as lanolin in the ointment), which can cause||
2125|063|P|allergic reactions or other problems. Talk to your pharmacist for||
2125|064|P|more details.||
2125|065|P|   Before using this medication, tell your doctor or pharmacist||
2125|066|P|your medical history.||
2125|067|P|   Before having surgery, tell your doctor or dentist about all||
2125|068|P|the products you use (including prescription drugs,||
2125|069|P|nonprescription drugs, and herbal products).||
2125|070|P|   During pregnancy, this medication should be used only when||
2125|071|P|clearly needed. Discuss the risks and benefits with your doctor.||
2125|072|P|   It is unknown if this medication passes into breast milk.||
2125|073|P|Consult your doctor before breastfeeding.||
2125|074|B|||
2125|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2125|076|I|medications work or increase your risk for serious side effects.||
2125|077|I|This document does not contain all possible drug interactions.||
2125|078|I|Keep a list of all the products you use (including||
2125|079|I|prescription/nonprescription drugs and herbal products) and share||
2125|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
2125|081|I|the dosage of any medicines without your doctor's approval.||
2125|082|B|||
2125|083|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2125|084|O|has overdosed and has serious symptoms such as passing out or||
2125|085|O|trouble breathing, call 911. Otherwise, call a poison control||
2125|086|O|center right away. US residents can call 1-800-222-1222. Canada||
2125|087|O|residents can call 1-844-764-7669.||
2125|088|B|||
2125|089|N|NOTES:  Do not share this medication with others.||
2125|090|N|   This medication has been prescribed for your current condition||
2125|091|N|only. Do not use it later for another infection unless your||
2125|092|N|doctor tells you to.||
2125|093|B|||
2125|094|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2125|095|D|If it is near the time of the next dose, skip the missed dose.||
2125|096|D|Use your next dose at the regular time. Do not double the dose to||
2125|097|D|catch up.||
2125|098|B|||
2125|099|R|STORAGE:  Store at room temperature. Keep all medications away||
2125|100|R|from children and pets.||
2125|101|R|   Do not flush medications down the toilet or pour them into a||
2125|102|R|drain unless instructed to do so. Properly discard this product||
2125|103|R|when it is expired or no longer needed. Consult your pharmacist||
2125|104|R|or local waste disposal company.||
2125|105|B|||
2125|106|A|Information last revised January 2025.||
2125|107|A|Copyright(c) 2025 First Databank, Inc.||
2125|108|B|||
2126|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2126|002|Z|does NOT have all possible information about this product. This||
2126|003|Z|information does not assure that this product is safe, effective,||
2126|004|Z|or appropriate for you. This information is not individual||
2126|005|Z|medical advice and does not substitute for the advice of your||
2126|006|Z|health care professional. Always ask your health care||
2126|007|Z|professional for complete information about this product and your||
2126|008|Z|specific health needs.||
2126|009|B|||
2126|010|T|MENTHOL/CAMPHOR - TOPICAL||
2126|011|F|(MEN-thol/KAM-for)||
2126|012|B|||
2126|013|C|COMMON BRAND NAME(S): Sarna||
2126|014|B|||
2126|015|U|USES:  This product is used to relieve itching and pain from||
2126|016|U|certain skin conditions (such as scrapes, minor burns, insect||
2126|017|U|bites, rash due to poison oak, poison ivy, or poison sumac).||
2126|018|U|Menthol is known as a counterirritant. It works by causing the||
2126|019|U|skin to feel cool and then warm. These feelings on the skin||
2126|020|U|distract you from feeling the ache or pain. Camphor helps to||
2126|021|U|relieve itching.||
2126|022|U|   Check the ingredients on the label even if you have used the||
2126|023|U|product before. The manufacturer may have changed the||
2126|024|U|ingredients. Also, products with similar names may contain||
2126|025|U|different ingredients meant for different purposes. Taking the||
2126|026|U|wrong product could harm you.||
2126|027|B|||
2126|028|H|HOW TO USE:  If you are using the over-the-counter product to||
2126|029|H|self-treat, read and follow all directions on the product package||
2126|030|H|before using this product. If you have any questions, consult||
2126|031|H|your pharmacist. If your doctor has prescribed this medication,||
2126|032|H|use it as directed.||
2126|033|H|   This product is for use on the skin only. Apply to the||
2126|034|H|affected area no more than 3 to 4 times a day. Rub in gently and||
2126|035|H|thoroughly.||
2126|036|H|   Wash your hands well after applying unless you are using this||
2126|037|H|product to treat the hands. Avoid getting this product in your||
2126|038|H|eyes, nose, or mouth. If you do get the product in those areas,||
2126|039|H|flush with plenty of water.||
2126|040|H|   Tell your doctor if your condition lasts for more than 7 days,||
2126|041|H|or if it gets worse, or if it keeps returning. If you think you||
2126|042|H|may have a serious medical problem, get medical help right away.||
2126|043|B|||
2126|044|S|SIDE EFFECTS:  Redness, warmth, or irritation at the application||
2126|045|S|site may occur. If any of these effects last or get worse, tell||
2126|046|S|your doctor or pharmacist promptly.||
2126|047|S|   If your doctor has directed you to use this product, remember||
2126|048|S|that your doctor has judged that the benefit to you is greater||
2126|049|S|than the risk of side effects. Many people using this medication||
2126|050|S|do not have serious side effects.||
2126|051|S|   Stop using this product and tell your doctor right away if you||
2126|052|S|have any serious side effects, including: blistering/swelling at||
2126|053|S|the application site, increased/unusual pain at the application||
2126|054|S|site.||
2126|055|S|   A very serious allergic reaction to this drug is rare.||
2126|056|S|However, get medical help right away if you notice any symptoms||
2126|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2126|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2126|059|S|breathing.||
2126|060|S|   This is not a complete list of possible side effects. If you||
2126|061|S|notice other effects not listed above, contact your doctor or||
2126|062|S|pharmacist.||
2126|063|S|   In the US -||
2126|064|S|   Call your doctor for medical advice about side effects. You||
2126|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2126|066|S|www.fda.gov/medwatch.||
2126|067|S|   In Canada - Call your doctor for medical advice about side||
2126|068|S|effects. You may report side effects to Health Canada at||
2126|069|S|1-866-234-2345.||
2126|070|B|||
2126|071|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2126|072|P|pharmacist if you are allergic to menthol; or to camphor; or if||
2126|073|P|you have any other allergies. This product may contain inactive||
2126|074|P|ingredients, which can cause allergic reactions or other||
2126|075|P|problems. Talk to your pharmacist for more details.||
2126|076|P|   Before using this product, tell your doctor or pharmacist your||
2126|077|P|medical history.||
2126|078|P|   Before having surgery, tell your doctor or dentist about all||
2126|079|P|the products you use (including prescription drugs,||
2126|080|P|nonprescription drugs, and herbal products).||
2126|081|P|   During pregnancy, this product should be used only when||
2126|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
2126|083|P|   It is unknown if this product passes into breast milk. Consult||
2126|084|P|your doctor before breastfeeding.||
2126|085|B|||
2126|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2126|087|I|medications work or increase your risk for serious side effects.||
2126|088|I|This document does not contain all possible drug interactions.||
2126|089|I|Keep a list of all the products you use (including||
2126|090|I|prescription/nonprescription drugs and herbal products) and share||
2126|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2126|092|I|the dosage of any medicines without your doctor's approval.||
2126|093|B|||
2126|094|O|OVERDOSE:  This product may be harmful if swallowed. If someone||
2126|095|O|has overdosed and has serious symptoms such as passing out or||
2126|096|O|trouble breathing, call 911. Otherwise, call a poison control||
2126|097|O|center right away. US residents can call 1-800-222-1222. Canada||
2126|098|O|residents can call 1-844-764-7669.||
2126|099|B|||
2126|100|N|NOTES:  Keep all medical and lab appointments.||
2126|101|B|||
2126|102|D|MISSED DOSE:  If you are using this product on a regular schedule||
2126|103|D|and miss a dose, use it as soon as you remember. If it is near||
2126|104|D|the time of the next dose, skip the missed dose. Use your next||
2126|105|D|dose at the regular time. Do not double the dose to catch up.||
2126|106|B|||
2126|107|R|STORAGE:  Store at room temperature. Different brands of this||
2126|108|R|medication have different storage needs. Check the product||
2126|109|R|package for instructions on how to store your brand, or ask your||
2126|110|R|pharmacist. Keep all medications away from children and pets.||
2126|111|R|   Do not flush medications down the toilet or pour them into a||
2126|112|R|drain unless instructed to do so. Properly discard this product||
2126|113|R|when it is expired or no longer needed. Consult your pharmacist||
2126|114|R|or local waste disposal company.||
2126|115|B|||
2126|116|A|Information last revised February 2025.||
2126|117|A|Copyright(c) 2025 First Databank, Inc.||
2126|118|B|||
2127|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2127|002|Z|does NOT have all possible information about this product. This||
2127|003|Z|information does not assure that this product is safe, effective,||
2127|004|Z|or appropriate for you. This information is not individual||
2127|005|Z|medical advice and does not substitute for the advice of your||
2127|006|Z|health care professional. Always ask your health care||
2127|007|Z|professional for complete information about this product and your||
2127|008|Z|specific health needs.||
2127|009|B|||
2127|010|T|TEDUGLUTIDE - INJECTION||
2127|011|F|(TE-due-GLOO-tide)||
2127|012|B|||
2127|013|C|COMMON BRAND NAME(S): Gattex||
2127|014|B|||
2127|015|U|USES:  Teduglutide is used by patients with Short Bowel Syndrome||
2127|016|U|(SBS) who need intravenous (IV) nutrition and fluids. It may help||
2127|017|U|to decrease the amount of intravenous nutrition needed by the||
2127|018|U|patient. Teduglutide is similar to a natural hormone in your body||
2127|019|U|(GLP-2). It works by helping to improve intestinal absorption of||
2127|020|U|fluids and nutrients.||
2127|021|B|||
2127|022|H|HOW TO USE:  Read the Medication Guide and the Instructions For||
2127|023|H|Use provided by your pharmacist before you start using||
2127|024|H|teduglutide and each time you get a refill. Ask your health care||
2127|025|H|professional how to prepare and use this medication. If you have||
2127|026|H|any questions, ask your doctor or pharmacist.||
2127|027|H|   Inject this medication under the skin as directed by your||
2127|028|H|doctor, usually once daily. The injection is given in the thigh,||
2127|029|H|abdomen, or upper arm. The dosage is based on your medical||
2127|030|H|condition, weight, and response to treatment.||
2127|031|H|   Do not shake the vial. Before using, check this product for||
2127|032|H|particles or discoloration. If either is present, do not use the||
2127|033|H|liquid. Before injecting each dose, clean the skin you are going||
2127|034|H|to inject into (the injection site) with rubbing alcohol. Change||
2127|035|H|the injection site each time to lessen injury under the skin. To||
2127|036|H|lessen bruising, do not rub the injection site after a shot.||
2127|037|H|Learn how to store and discard medical supplies safely.||
2127|038|H|   Use this medication regularly to get the most benefit from it.||
2127|039|H|To help you remember, use it at the same time each day.||
2127|040|B|||
2127|041|S|SIDE EFFECTS:  Decreased appetite, trouble sleeping, cough,||
2127|042|S|flu-like symptoms, or pain/redness/swelling at injection site may||
2127|043|S|occur. If any of these effects last or get worse, tell your||
2127|044|S|doctor or pharmacist promptly.||
2127|045|S|   Remember that this medication has been prescribed because your||
2127|046|S|doctor has judged that the benefit to you is greater than the||
2127|047|S|risk of side effects. Many people using this medication do not||
2127|048|S|have serious side effects.||
2127|049|S|   Tell your doctor right away if you have any serious side||
2127|050|S|effects, including: nausea/vomiting that doesn't stop, swelling||
2127|051|S|ankles/feet, unusual tiredness, sudden weight gain, severe||
2127|052|S|constipation, stomach/abdominal pain or swelling, yellowing||
2127|053|S|eyes/skin, dark urine, black/tarry stool, vomit that looks like||
2127|054|S|coffee grounds.||
2127|055|S|   This medication may increase the risk of cancer. Your doctor||
2127|056|S|will monitor you closely with lab and medical tests. See also||
2127|057|S|Notes section.||
2127|058|S|   A very serious allergic reaction to this drug is rare.||
2127|059|S|However, get medical help right away if you notice any symptoms||
2127|060|S|of a serious allergic reaction, including: rash, itching/swelling||
2127|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2127|062|S|breathing.||
2127|063|S|   This is not a complete list of possible side effects. If you||
2127|064|S|notice other effects not listed above, contact your doctor or||
2127|065|S|pharmacist.||
2127|066|S|   In the US -||
2127|067|S|   Call your doctor for medical advice about side effects. You||
2127|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2127|069|S|www.fda.gov/medwatch.||
2127|070|S|   In Canada - Call your doctor for medical advice about side||
2127|071|S|effects. You may report side effects to Health Canada at||
2127|072|S|1-866-234-2345.||
2127|073|B|||
2127|074|P|PRECAUTIONS:  Before using teduglutide, tell your doctor or||
2127|075|P|pharmacist if you are allergic to it; or if you have any other||
2127|076|P|allergies. This product may contain inactive ingredients, which||
2127|077|P|can cause allergic reactions or other problems. Talk to your||
2127|078|P|pharmacist for more details.||
2127|079|P|   Before using this medication, tell your doctor or pharmacist||
2127|080|P|your medical history, especially of: kidney disease, cancer,||
2127|081|P|gallbladder disease, disease of the pancreas (pancreatitis),||
2127|082|P|intestinal or rectal polyps, heart problems (such as heart||
2127|083|P|failure).||
2127|084|P|   Before having surgery, tell your doctor or dentist about all||
2127|085|P|the products you use (including prescription drugs,||
2127|086|P|nonprescription drugs, and herbal products).||
2127|087|P|   During pregnancy, this medication should be used only when||
2127|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
2127|089|P|   It is unknown if this medication passes into breast milk.||
2127|090|P|Because of the possible risk to the infant, breastfeeding is not||
2127|091|P|recommended while using this medication. Consult your doctor||
2127|092|P|before breastfeeding.||
2127|093|B|||
2127|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2127|095|I|medications work or increase your risk for serious side effects.||
2127|096|I|This document does not contain all possible drug interactions.||
2127|097|I|Keep a list of all the products you use (including||
2127|098|I|prescription/nonprescription drugs and herbal products) and share||
2127|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2127|100|I|the dosage of any medicines without your doctor's approval.||
2127|101|B|||
2127|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2127|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2127|104|O|poison control center right away. US residents can call||
2127|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2127|106|B|||
2127|107|N|NOTES:  Do not share this medication with others.||
2127|108|N|   Lab and/or medical tests (such as colonoscopy, fecal occult||
2127|109|N|blood testing, lipase/amylase levels, liver function) should be||
2127|110|N|done before you start using this medication and while you are||
2127|111|N|using it. Keep all medical and lab appointments. Consult your||
2127|112|N|doctor for more details.||
2127|113|B|||
2127|114|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2127|115|D|If you don't remember until the next day, skip the missed dose.||
2127|116|D|Use your next dose at the regular time. Do not double the dose or||
2127|117|D|use 2 doses on the same day to catch up.||
2127|118|B|||
2127|119|R|STORAGE:  Store the unmixed medication at room temperature. Do||
2127|120|R|not freeze. After mixing, use the mixed medication within 3 hours||
2127|121|R|and discard any unused portion. Keep all medications away from||
2127|122|R|children and pets.||
2127|123|R|   Do not flush medications down the toilet or pour them into a||
2127|124|R|drain unless instructed to do so. Properly discard this product||
2127|125|R|when it is expired or no longer needed. Consult your pharmacist||
2127|126|R|or local waste disposal company.||
2127|127|B|||
2127|128|A|Information last revised December 2024.||
2127|129|A|Copyright(c) 2025 First Databank, Inc.||
2127|130|B|||
2129|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2129|002|Z|does NOT have all possible information about this product. This||
2129|003|Z|information does not assure that this product is safe, effective,||
2129|004|Z|or appropriate for you. This information is not individual||
2129|005|Z|medical advice and does not substitute for the advice of your||
2129|006|Z|health care professional. Always ask your health care||
2129|007|Z|professional for complete information about this product and your||
2129|008|Z|specific health needs.||
2129|009|B|||
2129|010|T|MINOCYCLINE - DENTAL||
2129|011|F|(MIN-oh-SYE-kleen)||
2129|012|B|||
2129|013|C|COMMON BRAND NAME(S): Arestin||
2129|014|B|||
2129|015|U|USES:  This medication is used to treat adult gum disease||
2129|016|U|(periodontitis). Minocycline belongs to a class of drugs known as||
2129|017|U|tetracycline antibiotics. It works by preventing the growth of||
2129|018|U|bacteria. This medication is a powder that your dental||
2129|019|U|professional places into infected tooth pockets. Minocycline is||
2129|020|U|then slowly released over the next several weeks.||
2129|021|B|||
2129|022|H|HOW TO USE:  The dental professional will prepare each dose||
2129|023|H|before placing this product into the infected tooth pocket(s).||
2129|024|H|The dosage is based on your medical condition and response to||
2129|025|H|treatment.||
2129|026|H|   After this medication is placed in your tooth pocket(s), do||
2129|027|H|not touch any treated areas for 7 days. Avoid using treated teeth||
2129|028|H|to chew, and do not eat hard, crunchy, or chewy foods for 7 days.||
2129|029|H|Do not floss or clean between teeth treated with the medicine for||
2129|030|H|10 days after treatment. Follow your dentist's directions||
2129|031|H|carefully.||
2129|032|H|   Your dental professional may apply a second treatment with||
2129|033|H|this product. Keep all of your dental appointments while using||
2129|034|H|this medication.||
2129|035|H|   Tell your dentist if your condition lasts or gets worse.||
2129|036|B|||
2129|037|S|SIDE EFFECTS:  Headache, gum discomfort/pain/soreness or||
2129|038|S|toothache may occur. If any of these effects last or get worse,||
2129|039|S|tell your dentist or pharmacist promptly.||
2129|040|S|   Remember that this medication has been prescribed because your||
2129|041|S|dentist has judged that the benefit to you is greater than the||
2129|042|S|risk of side effects. Many people using this medication do not||
2129|043|S|have serious side effects.||
2129|044|S|   Tell your dentist right away if you have any serious side||
2129|045|S|effects, including: tooth loosening, jaw pain.||
2129|046|S|   A very serious allergic reaction to this drug is rare.||
2129|047|S|However, get medical help right away if you notice any symptoms||
2129|048|S|of a serious allergic reaction, including: rash, itching/swelling||
2129|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2129|050|S|breathing.||
2129|051|S|   This is not a complete list of possible side effects. If you||
2129|052|S|notice other effects not listed above, contact your doctor or||
2129|053|S|pharmacist.||
2129|054|S|   In the US -||
2129|055|S|   Call your doctor for medical advice about side effects. You||
2129|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2129|057|S|www.fda.gov/medwatch.||
2129|058|S|   In Canada - Call your doctor for medical advice about side||
2129|059|S|effects. You may report side effects to Health Canada at||
2129|060|S|1-866-234-2345.||
2129|061|B|||
2129|062|P|PRECAUTIONS:  Before using minocycline, tell your dentist or||
2129|063|P|pharmacist if you are allergic to it; or to other tetracyclines;||
2129|064|P|or if you have any other allergies. This product may contain||
2129|065|P|inactive ingredients, which can cause allergic reactions or other||
2129|066|P|problems. Talk to your pharmacist for more details.||
2129|067|P|   Before using this medication, tell your dentist or pharmacist||
2129|068|P|your medical history, especially of: past/current fungal||
2129|069|P|infections of the mouth/vagina (such as thrush, yeast infection).||
2129|070|P|   This medication may make you more sensitive to the sun. Limit||
2129|071|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2129|072|P|sunscreen and wear protective clothing when outdoors. Tell your||
2129|073|P|doctor right away if you get sunburned or have skin||
2129|074|P|blisters/redness.||
2129|075|P|   Children younger than 8 years may be more sensitive to the||
2129|076|P|side effects of minocycline, especially tooth discoloration.||
2129|077|P|Tooth discoloration has also occurred in older children and young||
2129|078|P|adults. Discuss the risks and benefits of this medication with||
2129|079|P|the doctor.||
2129|080|P|   Tell your dentist if you are pregnant or plan to become||
2129|081|P|pregnant. You should not become pregnant while using minocycline.||
2129|082|P|Minocycline may harm an unborn baby. If you become pregnant, talk||
2129|083|P|to your dentist or doctor right away about the risks and benefits||
2129|084|P|of this medication.||
2129|085|P|   This medication passes into breast milk. Consult your dentist||
2129|086|P|or doctor before breastfeeding.||
2129|087|B|||
2129|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2129|089|I|medications work or increase your risk for serious side effects.||
2129|090|I|This document does not contain all possible drug interactions.||
2129|091|I|Keep a list of all the products you use (including||
2129|092|I|prescription/nonprescription drugs and herbal products) and share||
2129|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
2129|094|I|the dosage of any medicines without your doctor's approval.||
2129|095|B|||
2129|096|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2129|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2129|098|O|poison control center right away. US residents can call||
2129|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2129|100|B|||
2129|101|N|NOTES:  Proper dental hygiene (including tooth brushing and||
2129|102|N|flossing) on a daily basis and having regular visits to your||
2129|103|N|dentist may help to prevent tooth and gum problems. Discuss this||
2129|104|N|with your dental professional.||
2129|105|B|||
2129|106|D|MISSED DOSE:  Not applicable.||
2129|107|B|||
2129|108|R|STORAGE:  Store at room temperature. Keep all medications away||
2129|109|R|from children and pets.||
2129|110|R|   Do not flush medications down the toilet or pour them into a||
2129|111|R|drain unless instructed to do so. Properly discard this product||
2129|112|R|when it is expired or no longer needed. Consult your pharmacist||
2129|113|R|or local waste disposal company.||
2129|114|B|||
2129|115|A|Information last revised January 2025.||
2129|116|A|Copyright(c) 2025 First Databank, Inc.||
2129|117|B|||
2130|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2130|002|Z|does NOT have all possible information about this product. This||
2130|003|Z|information does not assure that this product is safe, effective,||
2130|004|Z|or appropriate for you. This information is not individual||
2130|005|Z|medical advice and does not substitute for the advice of your||
2130|006|Z|health care professional. Always ask your health care||
2130|007|Z|professional for complete information about this product and your||
2130|008|Z|specific health needs.||
2130|009|B|||
2130|010|T|CORTICOTROPIN - INJECTION||
2130|011|F|(KOR-ti-koe-TROE-pin)||
2130|012|B|||
2130|013|C|COMMON BRAND NAME(S): Acthar||
2130|014|B|||
2130|015|U|USES:  This medication is used to treat a certain type of seizure||
2130|016|U|in children (infantile spasms). This medication is also used to||
2130|017|U|treat conditions such as multiple sclerosis, arthritis, lupus,||
2130|018|U|eye conditions, skin/kidney/lung diseases, and immune system||
2130|019|U|disorders. It decreases your immune system's response to various||
2130|020|U|diseases to reduce symptoms such as swelling, pain, and||
2130|021|U|allergic-type reactions. Corticotropin is a hormone.||
2130|022|B|||
2130|023|H|HOW TO USE:  If you are using this medication to treat infantile||
2130|024|H|spasms, read the Medication Guide provided by your pharmacist||
2130|025|H|before you start using corticotropin and each time you get a||
2130|026|H|refill. If you are using the pre-filled injector, read the||
2130|027|H|Instructions for Use if available from your pharmacist. Ask your||
2130|028|H|health care professional how to prepare and use this medication.||
2130|029|H|If you have any questions, ask your doctor or pharmacist.||
2130|030|H|   Inject this medication into a muscle or under the skin as||
2130|031|H|directed by your doctor. For infantile spasms, this medication||
2130|032|H|should be given by injection into a muscle. If you are using the||
2130|033|H|pre-filled injector, it should only be injected under the skin.||
2130|034|H|The dosage is based on your body size, medical condition, and||
2130|035|H|response to treatment. Do not increase your dose or use this drug||
2130|036|H|more often than prescribed without consulting your doctor. Your||
2130|037|H|condition will not improve any faster, and your risk of side||
2130|038|H|effects will increase.||
2130|039|H|   Before use, take this medication out of the refrigerator. If||
2130|040|H|you are using the vials, roll the vial in your hands for a few||
2130|041|H|minutes. If you are using the pre-filled injector, let it warm up||
2130|042|H|to room temperature for 45 minutes. Do not warm up this||
2130|043|H|medication any other way (for example, do not heat it in the||
2130|044|H|microwave, place it in hot water, or leave it in direct||
2130|045|H|sunlight). Before using, check this product for particles or||
2130|046|H|discoloration. If either is present, do not use the liquid.||
2130|047|H|Before injecting each dose, clean the skin you are going to||
2130|048|H|inject into (the injection site) with rubbing alcohol. Change the||
2130|049|H|injection site each time to lessen injury under the skin. To||
2130|050|H|lessen bruising, do not rub the injection site after a shot.||
2130|051|H|Learn how to store and discard medical supplies safely.||
2130|052|H|   Do not stop using this medication without consulting your||
2130|053|H|doctor. Some conditions may become worse when this drug is||
2130|054|H|suddenly stopped. Your dose may need to be gradually decreased.||
2130|055|H|   Use this medication regularly to get the most benefit from it.||
2130|056|H|To help you remember, use it at the same time(s) each day.||
2130|057|H|   Tell your doctor if your condition gets worse.||
2130|058|B|||
2130|059|S|SIDE EFFECTS:  Vomiting, diarrhea, trouble sleeping, appetite||
2130|060|S|changes, or pain/redness/swelling at the injection site may||
2130|061|S|occur. If any of these effects last or get worse, tell your||
2130|062|S|doctor or pharmacist promptly.||
2130|063|S|   Remember that this medication has been prescribed because your||
2130|064|S|doctor has judged that the benefit to you is greater than the||
2130|065|S|risk of side effects. Many people using this medication do not||
2130|066|S|have serious side effects.||
2130|067|S|   This medication may rarely make your blood sugar rise, which||
2130|068|S|can cause or worsen diabetes. Tell your doctor right away if you||
2130|069|S|have symptoms of high blood sugar, such as increased||
2130|070|S|thirst/urination. If you already have diabetes, check your blood||
2130|071|S|sugar regularly as directed and share the results with your||
2130|072|S|doctor. Your doctor may need to adjust your diabetes medication,||
2130|073|S|exercise program, or diet.||
2130|074|S|   This medication may lower your ability to fight infections.||
2130|075|S|This may make you more likely to get a serious (rarely fatal)||
2130|076|S|infection or make any infection you have worse. Tell your doctor||
2130|077|S|right away if you have any signs of infection (such as fever,||
2130|078|S|chills, sore throat that doesn't go away, white patches in the||
2130|079|S|mouth).||
2130|080|S|   This medication may raise your blood pressure. Check your||
2130|081|S|blood pressure regularly and tell your doctor if the results are||
2130|082|S|high.||
2130|083|S|   Tell your doctor right away if you have any serious side||
2130|084|S|effects, including: weakness, puffy face, unusual weight gain,||
2130|085|S|slow wound healing, thinning skin, bone pain, menstrual period||
2130|086|S|changes, mental/mood changes (such as mood swings, depression,||
2130|087|S|agitation), easy bruising/bleeding, increased thirst/urination,||
2130|088|S|vision problems, swelling ankles/feet/hands, fast/slow/irregular||
2130|089|S|heartbeat.||
2130|090|S|   This drug may rarely cause serious (rarely fatal) bleeding||
2130|091|S|from the stomach or intestines. If you notice any of the||
2130|092|S|following unlikely but serious side effects, get medical help||
2130|093|S|right away: stomach/abdominal pain that doesn't go away, black||
2130|094|S|stools, vomit that looks like coffee grounds.||
2130|095|S|   A very serious allergic reaction to this drug is rare.||
2130|096|S|However, get medical help right away if you notice any symptoms||
2130|097|S|of a serious allergic reaction, including: rash, itching/swelling||
2130|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2130|099|S|breathing.||
2130|100|S|   This is not a complete list of possible side effects. If you||
2130|101|S|notice other effects not listed above, contact your doctor or||
2130|102|S|pharmacist.||
2130|103|S|   In the US -||
2130|104|S|   Call your doctor for medical advice about side effects. You||
2130|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2130|106|S|www.fda.gov/medwatch.||
2130|107|S|   In Canada - Call your doctor for medical advice about side||
2130|108|S|effects. You may report side effects to Health Canada at||
2130|109|S|1-866-234-2345.||
2130|110|B|||
2130|111|P|PRECAUTIONS:  Before using corticotropin, tell your doctor or||
2130|112|P|pharmacist if you are allergic to it; or to pork products; or if||
2130|113|P|you have any other allergies. This product may contain inactive||
2130|114|P|ingredients, which can cause allergic reactions or other||
2130|115|P|problems. Talk to your pharmacist for more details.||
2130|116|P|   Before using this medication, tell your doctor or pharmacist||
2130|117|P|your medical history, especially of: adrenal gland problems,||
2130|118|P|brittle bones (osteoporosis), current/ past infections (such as||
2130|119|P|those caused by tuberculosis, threadworm, herpes, fungus),||
2130|120|P|stomach/intestinal problems (such as diverticulitis, ulcer,||
2130|121|P|ulcerative colitis), heart problems (such as heart failure,||
2130|122|P|recent heart attack), high blood pressure, eye diseases (such as||
2130|123|P|cataracts, glaucoma, herpes infection of the eye), diabetes,||
2130|124|P|kidney disease, liver disease, mental/mood conditions (such as||
2130|125|P|psychosis, anxiety, depression), a certain skin/connective tissue||
2130|126|P|disease (scleroderma), thyroid problems.||
2130|127|P|   This medication may cause stomach bleeding. Daily use of||
2130|128|P|alcohol while using this medication may increase your risk for||
2130|129|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
2130|130|P|or pharmacist for more information.||
2130|131|P|   Corticotropin can make you more likely to get infections or||
2130|132|P|may make current infections worse. Stay away from anyone who has||
2130|133|P|an infection that may easily spread (such as chickenpox,||
2130|134|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2130|135|P|exposed to an infection or for more details.||
2130|136|P|   Tell your health care professional that you are using||
2130|137|P|corticotropin before having any immunizations, vaccinations, or||
2130|138|P|skin tests. Avoid contact with people who have recently received||
2130|139|P|live vaccines (such as flu vaccine inhaled through the nose).||
2130|140|P|   Using this medication for a long time can make it more||
2130|141|P|difficult for your body to respond to physical stress. Before||
2130|142|P|having surgery or emergency treatment, or if you get a serious||
2130|143|P|illness/injury, tell your doctor or dentist that you are using||
2130|144|P|this medication or have used this medication within the past 12||
2130|145|P|months. Tell your doctor right away if you develop||
2130|146|P|unusual/extreme tiredness or weight loss. If you will be using||
2130|147|P|this medication for a long time, carry a warning card or medical||
2130|148|P|ID bracelet that identifies your use of this medication.||
2130|149|P|   Older adults may be more sensitive to the side effects of this||
2130|150|P|drug, especially brittle bones (osteoporosis). Talk to your||
2130|151|P|doctor about ways to prevent osteoporosis. See also Notes||
2130|152|P|section.||
2130|153|P|   This medication may slow down a child's growth if used for a||
2130|154|P|long time. Consult the doctor or pharmacist for more details. See||
2130|155|P|the doctor regularly so your child's height and growth can be||
2130|156|P|checked.||
2130|157|P|   During pregnancy, this medication should be used only when||
2130|158|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
2130|159|P|risks and benefits with your doctor. Infants born to mothers who||
2130|160|P|use this medication for a long time during pregnancy may have||
2130|161|P|hormone problems. Tell your doctor right away if you notice||
2130|162|P|symptoms such as nausea/vomiting that doesn't stop, severe||
2130|163|P|diarrhea, or weakness in your newborn.||
2130|164|P|   It is unknown if this medication passes into breast milk.||
2130|165|P|Consult your doctor before breastfeeding.||
2130|166|B|||
2130|167|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2130|168|I|medications work or increase your risk for serious side effects.||
2130|169|I|This document does not contain all possible drug interactions.||
2130|170|I|Keep a list of all the products you use (including||
2130|171|I|prescription/nonprescription drugs and herbal products) and share||
2130|172|I|it with your doctor and pharmacist. Do not start, stop, or change||
2130|173|I|the dosage of any medicines without your doctor's approval.||
2130|174|B|||
2130|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2130|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2130|177|O|poison control center right away. US residents can call||
2130|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2130|179|B|||
2130|180|N|NOTES:  Do not share this medication with others.||
2130|181|N|   Lab and/or medical tests (such as blood sugar/mineral levels,||
2130|182|N|blood pressure, eye exams, bone density tests, height/weight||
2130|183|N|measurements) should be done while you are using this medication.||
2130|184|N|Consult your doctor for more details.||
2130|185|N|   This medication may cause bone loss (osteoporosis) when used||
2130|186|N|for a long time. Lifestyle changes that may help reduce the risk||
2130|187|N|of bone problems include doing weight-bearing exercise, stopping||
2130|188|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2130|189|N|D. Talk to your doctor for more details.||
2130|190|B|||
2130|191|D|MISSED DOSE:  It is important to get each dose of this medication||
2130|192|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2130|193|D|right away for a new dosing schedule. Do not double the dose to||
2130|194|D|catch up.||
2130|195|B|||
2130|196|R|STORAGE:  Store in the refrigerator. Different brands of this||
2130|197|R|medication have different storage needs. Check the product||
2130|198|R|package for instructions on how to store your brand, or ask your||
2130|199|R|pharmacist. Keep all medications away from children and pets.||
2130|200|R|   Do not flush medications down the toilet or pour them into a||
2130|201|R|drain unless instructed to do so. Properly discard this product||
2130|202|R|when it is expired or no longer needed. Consult your pharmacist||
2130|203|R|or local waste disposal company.||
2130|204|B|||
2130|205|M|MEDICAL ALERT:  Your condition can cause complications in a||
2130|206|M|medical emergency. For information about enrolling in MedicAlert,||
2130|207|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2130|208|B|||
2130|209|A|Information last revised September 2025.||
2130|210|A|Copyright(c) 2025 First Databank, Inc.||
2130|211|B|||
2131|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2131|002|Z|does NOT have all possible information about this product. This||
2131|003|Z|information does not assure that this product is safe, effective,||
2131|004|Z|or appropriate for you. This information is not individual||
2131|005|Z|medical advice and does not substitute for the advice of your||
2131|006|Z|health care professional. Always ask your health care||
2131|007|Z|professional for complete information about this product and your||
2131|008|Z|specific health needs.||
2131|009|B|||
2131|010|T|ELEXACAFTOR/TEZACAFTOR/IVACAFTOR AND IVACAFTOR TABLETS - ORAL||
2131|011|F|(el-EX-a-KAF-tor/TEZ-a-KAF-tor/EYE-va-KAF-tor and EYE-va-KAF-tor)||
2131|012|B|||
2131|013|C|COMMON BRAND NAME(S): Trikafta||
2131|014|B|||
2131|015|W|WARNING:  This medication may rarely cause serious (possibly||
2131|016|W|fatal) liver problems. Before and during treatment with this||
2131|017|W|medication, you will have certain blood tests (liver function) to||
2131|018|W|monitor for liver problems. Keep all medical and lab||
2131|019|W|appointments. Get medical help right away if you have any||
2131|020|W|symptoms of liver damage, such as: nausea/vomiting that doesn't||
2131|021|W|stop, stomach/abdominal pain, dark urine, loss of appetite,||
2131|022|W|yellowing eyes/skin.||
2131|023|B|||
2131|024|U|USES:  This product has 2 different tablets. One tablet contains||
2131|025|U|3 medications (it is a "multi-drug"): elexacaftor, tezacaftor,||
2131|026|U|and ivacaftor. The other tablet contains only ivacaftor.||
2131|027|U|   This product is used to treat cystic fibrosis in certain||
2131|028|U|people (those with an abnormal "CFTR" gene). It may help to||
2131|029|U|improve breathing, reduce the risk of lung infections, and||
2131|030|U|improve weight gain.||
2131|031|B|||
2131|032|H|HOW TO USE:  Read the Medication Guide provided by your||
2131|033|H|pharmacist before you start using this medication and each time||
2131|034|H|you get a refill. If you have any questions, ask your doctor or||
2131|035|H|pharmacist.||
2131|036|H|   Take these medications by mouth as directed by your doctor,||
2131|037|H|usually 2 multi-drug tablets in the morning, and 1 ivacaftor||
2131|038|H|tablet about 12 hours later in the evening. Take the tablets with||
2131|039|H|food that contains fat. Some examples are eggs, meat, nuts,||
2131|040|H|butter, peanut butter, whole-milk dairy products (such as whole||
2131|041|H|milk, cheese, yogurt).||
2131|042|H|   The manufacturer directs to swallow this medication whole.||
2131|043|H|However, many similar drugs (immediate-release tablets) can be||
2131|044|H|split/crushed. Follow your doctor's directions on how to take||
2131|045|H|this medication.||
2131|046|H|   The dosage is based on your medical condition, age, weight,||
2131|047|H|response to treatment, and other medications you may be taking.||
2131|048|H|Be sure to tell your doctor and pharmacist about all the products||
2131|049|H|you use (including prescription drugs, nonprescription drugs, and||
2131|050|H|herbal products).||
2131|051|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2131|052|H|using this medication unless your doctor or pharmacist says you||
2131|053|H|may do so safely. Grapefruit can increase the chance of side||
2131|054|H|effects with this medicine. Ask your doctor or pharmacist for||
2131|055|H|more details.||
2131|056|H|   Use this product regularly to get the most benefit from it. To||
2131|057|H|help you remember, take it at the same times each day.||
2131|058|H|   Tell your doctor if you do not get better or if you get worse.||
2131|059|B|||
2131|060|S|SIDE EFFECTS:  See also Warning section.||
2131|061|S|   Headache, diarrhea, or dizziness may occur. If any of these||
2131|062|S|effects last or get worse, tell your doctor or pharmacist||
2131|063|S|promptly.||
2131|064|S|   Remember that this product has been prescribed because your||
2131|065|S|doctor has judged that the benefit to you is greater than the||
2131|066|S|risk of side effects. Many people using this product do not have||
2131|067|S|serious side effects.||
2131|068|S|   This medication may rarely cause increased pressure around the||
2131|069|S|brain (intracranial hypertension-IH). Get medical help right away||
2131|070|S|if any of these very serious side effects occur: headache that is||
2131|071|S|severe or doesn't go away, vision changes (such as blurred/double||
2131|072|S|vision, decreased vision).||
2131|073|S|   This product can commonly cause a rash (especially in females)||
2131|074|S|that is usually not serious. However, you may not be able to tell||
2131|075|S|it apart from a rare rash that could be a sign of a severe||
2131|076|S|reaction. Get medical help right away if you develop any rash.||
2131|077|S|   A very serious allergic reaction to this drug is rare.||
2131|078|S|However, get medical help right away if you notice any symptoms||
2131|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2131|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2131|081|S|breathing.||
2131|082|S|   This is not a complete list of possible side effects. If you||
2131|083|S|notice other effects not listed above, contact your doctor or||
2131|084|S|pharmacist.||
2131|085|S|   In the US -||
2131|086|S|   Call your doctor for medical advice about side effects. You||
2131|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2131|088|S|www.fda.gov/medwatch.||
2131|089|S|   In Canada - Call your doctor for medical advice about side||
2131|090|S|effects. You may report side effects to Health Canada at||
2131|091|S|1-866-234-2345.||
2131|092|B|||
2131|093|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2131|094|P|pharmacist if you are allergic to elexacaftor, tezacaftor, or||
2131|095|P|ivacaftor; or if you have any other allergies. This product may||
2131|096|P|contain inactive ingredients, which can cause allergic reactions||
2131|097|P|or other problems. Talk to your pharmacist for more details.||
2131|098|P|   Before using this product, tell your doctor or pharmacist your||
2131|099|P|medical history, especially of: liver disease, kidney disease.||
2131|100|P|   This product may make you dizzy. Alcohol or marijuana||
2131|101|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
2131|102|P|or do anything that needs alertness until you can do it safely.||
2131|103|P|Limit alcoholic beverages. Talk to your doctor if you are using||
2131|104|P|marijuana (cannabis).||
2131|105|P|   Before having surgery, tell your doctor or dentist about all||
2131|106|P|the products you use (including prescription drugs,||
2131|107|P|nonprescription drugs, and herbal products).||
2131|108|P|   During pregnancy, this product should be used only when||
2131|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
2131|110|P|   This product passes into breast milk. Consult your doctor||
2131|111|P|before breastfeeding.||
2131|112|B|||
2131|113|I|DRUG INTERACTIONS:  See also How to Use section.||
2131|114|I|   Drug interactions may change how your medications work or||
2131|115|I|increase your risk for serious side effects. This document does||
2131|116|I|not contain all possible drug interactions. Keep a list of all||
2131|117|I|the products you use (including prescription/nonprescription||
2131|118|I|drugs and herbal products) and share it with your doctor and||
2131|119|I|pharmacist. Do not start, stop, or change the dosage of any||
2131|120|I|medicines without your doctor's approval.||
2131|121|I|   Other medications can affect the removal of elexacaftor,||
2131|122|I|tezacaftor, and ivacaftor from your body, which may affect how||
2131|123|I|this product works. Examples include mifepristone, rifamycins||
2131|124|I|(such as rifampin, rifabutin), drugs for seizures (such as||
2131|125|I|carbamazepine, phenytoin), St. John's wort, among others.||
2131|126|B|||
2131|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2131|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2131|129|O|poison control center right away. US residents can call||
2131|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2131|131|B|||
2131|132|N|NOTES:  Do not share this product with others.||
2131|133|N|   Lab and/or medical tests (such as CFTR gene testing,||
2131|134|N|liver/lung function, eye exams) should be done before you start||
2131|135|N|taking this product and while you are taking it. Keep all medical||
2131|136|N|and lab appointments.||
2131|137|B|||
2131|138|D|MISSED DOSE:  If you miss a morning or evening dose and it has||
2131|139|D|been less than 6 hours, take it as soon as you remember. Do not||
2131|140|D|take a morning and evening dose at the same time. Do not double||
2131|141|D|the dose to catch up.||
2131|142|D|   If you miss the morning dose and it has been more than 6||
2131|143|D|hours, take it as soon as you remember and do not take the||
2131|144|D|evening dose. Take your next day's doses at the regular times.||
2131|145|D|   If you miss the evening dose and it has been more than 6||
2131|146|D|hours, skip the missed evening dose. Take your next day's doses||
2131|147|D|at the regular times.||
2131|148|B|||
2131|149|R|STORAGE:  Store at room temperature away from light and moisture.||
2131|150|R|Do not store in the bathroom. Keep all medications away from||
2131|151|R|children and pets.||
2131|152|R|   Do not flush medications down the toilet or pour them into a||
2131|153|R|drain unless instructed to do so. Properly discard this product||
2131|154|R|when it is expired or no longer needed. Consult your pharmacist||
2131|155|R|or local waste disposal company.||
2131|156|B|||
2131|157|A|Information last revised September 2025.||
2131|158|A|Copyright(c) 2025 First Databank, Inc.||
2131|159|B|||
2132|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2132|002|Z|does NOT have all possible information about this product. This||
2132|003|Z|information does not assure that this product is safe, effective,||
2132|004|Z|or appropriate for you. This information is not individual||
2132|005|Z|medical advice and does not substitute for the advice of your||
2132|006|Z|health care professional. Always ask your health care||
2132|007|Z|professional for complete information about this product and your||
2132|008|Z|specific health needs.||
2132|009|B|||
2132|010|T|TRIMETHOBENZAMIDE - INJECTION||
2132|011|F|(trye-METH-oh-BEN-za-mide)||
2132|012|B|||
2132|013|C|COMMON BRAND NAME(S): Tigan||
2132|014|B|||
2132|015|U|USES:  This medication is used to treat nausea and vomiting that||
2132|016|U|can happen due to surgery or certain stomach/intestinal problems||
2132|017|U|(such as gastroenteritis). Treating vomiting quickly can keep you||
2132|018|U|from getting dehydrated. Trimethobenzamide belongs to a class of||
2132|019|U|drugs known as antiemetics. It works by stopping the signals in||
2132|020|U|the brain that cause vomiting.||
2132|021|U|   Trimethobenzamide injection must not be used by children.||
2132|022|B|||
2132|023|H|HOW TO USE:  This medication is given by injection into a large||
2132|024|H|muscle of the buttock by a health care professional. It is given||
2132|025|H|as directed by your doctor, usually 3 to 4 times a day as needed.||
2132|026|H|This medication should not be injected into a vein. The dosage is||
2132|027|H|based on your medical condition and response to treatment.||
2132|028|H|   Tell your doctor if your condition lasts or gets worse.||
2132|029|B|||
2132|030|S|SIDE EFFECTS:  Diarrhea, headache, dizziness, drowsiness, blurred||
2132|031|S|vision, muscle cramps, or pain/stinging/burning/redness at the||
2132|032|S|injection site may occur. If any of these effects last or get||
2132|033|S|worse, tell your doctor or pharmacist promptly.||
2132|034|S|   Remember that this medication has been prescribed because your||
2132|035|S|doctor has judged that the benefit to you is greater than the||
2132|036|S|risk of side effects. Many people using this medication do not||
2132|037|S|have serious side effects.||
2132|038|S|   Tell your doctor right away if you have any serious side||
2132|039|S|effects, including: confusion, muscle spasms, unusual||
2132|040|S|uncontrolled movements (especially of the face, mouth, tongue,||
2132|041|S|arms, or legs), shaking (tremor), restlessness, drooling, severe||
2132|042|S|arching of the back, mouth sores, unusual bleeding/bruising,||
2132|043|S|mental/mood changes (such as depression), yellowing eyes/skin,||
2132|044|S|dark urine.||
2132|045|S|   Get medical help right away if you have any very serious side||
2132|046|S|effects, including: seizures.||
2132|047|S|   A very serious allergic reaction to this drug is rare.||
2132|048|S|However, get medical help right away if you notice any symptoms||
2132|049|S|of a serious allergic reaction, including: rash, itching/swelling||
2132|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2132|051|S|breathing.||
2132|052|S|   This is not a complete list of possible side effects. If you||
2132|053|S|notice other effects not listed above, contact your doctor or||
2132|054|S|pharmacist.||
2132|055|S|   In the US -||
2132|056|S|   Call your doctor for medical advice about side effects. You||
2132|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2132|058|S|www.fda.gov/medwatch.||
2132|059|S|   In Canada - Call your doctor for medical advice about side||
2132|060|S|effects. You may report side effects to Health Canada at||
2132|061|S|1-866-234-2345.||
2132|062|B|||
2132|063|P|PRECAUTIONS:  Before using trimethobenzamide, tell your doctor or||
2132|064|P|pharmacist if you are allergic to it; or if you have any other||
2132|065|P|allergies. This product may contain inactive ingredients, which||
2132|066|P|can cause allergic reactions or other problems. Talk to your||
2132|067|P|pharmacist for more details.||
2132|068|P|   Before using this medication, tell your doctor or pharmacist||
2132|069|P|your medical history, especially of: high fever, kidney problems,||
2132|070|P|stomach/intestinal problems (such as appendicitis),||
2132|071|P|swelling/disease of the brain (encephalitis/encephalopathy),||
2132|072|P|dehydration, electrolyte imbalance.||
2132|073|P|   This drug may make you dizzy or drowsy or cause blurred||
2132|074|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
2132|075|P|or drowsy. Do not drive, use machinery, or do anything that needs||
2132|076|P|alertness or clear vision until you can do it safely. Avoid||
2132|077|P|alcoholic beverages. Talk to your doctor if you are using||
2132|078|P|marijuana (cannabis).||
2132|079|P|   Older adults may be more sensitive to the side effects of this||
2132|080|P|drug, especially unusual uncontrolled movements and shaking.||
2132|081|P|   During pregnancy, this medication should be used only when||
2132|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
2132|083|P|   It is unknown if this drug passes into breast milk. Consult||
2132|084|P|your doctor before breastfeeding.||
2132|085|B|||
2132|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2132|087|I|medications work or increase your risk for serious side effects.||
2132|088|I|This document does not contain all possible drug interactions.||
2132|089|I|Keep a list of all the products you use (including||
2132|090|I|prescription/nonprescription drugs and herbal products) and share||
2132|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2132|092|I|the dosage of any medicines without your doctor's approval.||
2132|093|I|   Tell your doctor or pharmacist if you are taking other||
2132|094|I|products that cause drowsiness such as opioid pain or cough||
2132|095|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2132|096|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2132|097|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2132|098|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2132|099|I|diphenhydramine).||
2132|100|I|   Check the labels on all your medicines (such as allergy or||
2132|101|I|cough-and-cold products) because they may contain ingredients||
2132|102|I|that cause drowsiness. Ask your pharmacist about using those||
2132|103|I|products safely.||
2132|104|B|||
2132|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2132|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2132|107|O|poison control center right away. US residents can call||
2132|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2132|109|B|||
2132|110|N|NOTES:  Do not share this medication with others.||
2132|111|N|   Lab and/or medical tests (such as complete blood counts, liver||
2132|112|N|function) should be done while you are using this medication.||
2132|113|N|Keep all medical and lab appointments.||
2132|114|B|||
2132|115|D|MISSED DOSE:  Not applicable.||
2132|116|B|||
2132|117|R|STORAGE:  Store at room temperature. Keep all medications away||
2132|118|R|from children and pets.||
2132|119|R|   Do not flush medications down the toilet or pour them into a||
2132|120|R|drain unless instructed to do so. Properly discard this product||
2132|121|R|when it is expired or no longer needed. Consult your pharmacist||
2132|122|R|or local waste disposal company.||
2132|123|B|||
2132|124|A|Information last revised December 2024.||
2132|125|A|Copyright(c) 2025 First Databank, Inc.||
2132|126|B|||
2133|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2133|002|Z|does NOT have all possible information about this product. This||
2133|003|Z|information does not assure that this product is safe, effective,||
2133|004|Z|or appropriate for you. This information is not individual||
2133|005|Z|medical advice and does not substitute for the advice of your||
2133|006|Z|health care professional. Always ask your health care||
2133|007|Z|professional for complete information about this product and your||
2133|008|Z|specific health needs.||
2133|009|B|||
2133|010|T|CLADRIBINE - INJECTION||
2133|011|F|(KLAD-rib-een)||
2133|012|B|||
2133|013|C|COMMON BRAND NAME(S): Leustatin||
2133|014|B|||
2133|015|W|WARNING:  This medication may cause very serious blood disorders||
2133|016|W|(decreased bone marrow function leading to low number of blood||
2133|017|W|cells such as white cells, red cells, and platelets). This effect||
2133|018|W|can weaken the immune system/increase the risk of infection,||
2133|019|W|cause anemia, or cause your body to bruise or bleed easier. Tell||
2133|020|W|your doctor right away if you develop any of the following: signs||
2133|021|W|of infection (such as sore throat that doesn't go away, fever,||
2133|022|W|chills), easy bruising/bleeding, unusual tiredness, fast/pounding||
2133|023|W|heartbeat.||
2133|024|W|   When used in high doses, cladribine may cause very serious||
2133|025|W|kidney or nerve problems. Nerve problems may also rarely occur in||
2133|026|W|patients taking the normal dose of cladribine. Get medical help||
2133|027|W|right away if you develop any of the following: change in the||
2133|028|W|amount of urine, weakness/numbness/tingling in your hands/feet,||
2133|029|W|or inability to move your arms/legs.||
2133|030|W|   Cladribine may increase your risk of getting a rare but very||
2133|031|W|serious (possibly fatal) brain infection (progressive multifocal||
2133|032|W|leukoencephalopathy-PML). Get medical help right away if you have||
2133|033|W|any of these side effects: clumsiness, loss of||
2133|034|W|coordination/balance, weakness, sudden change in your thinking||
2133|035|W|(such as confusion, difficulty concentrating, memory loss),||
2133|036|W|difficulty talking, seizures, or sudden vision changes. See also||
2133|037|W|Side Effects section.||
2133|038|B|||
2133|039|U|USES:  Cladribine is used to treat a certain type of cancer||
2133|040|U|(hairy cell leukemia). It works by stopping the growth of cancer||
2133|041|U|cells.||
2133|042|B|||
2133|043|V|OTHER USES:  This section contains uses of this drug that are not||
2133|044|V|listed in the approved professional labeling for the drug but||
2133|045|V|that may be prescribed by your health care professional. Use this||
2133|046|V|drug for a condition that is listed in this section only if it||
2133|047|V|has been so prescribed by your health care professional.||
2133|048|V|   This drug may also be used for other types of cancer (certain||
2133|049|V|lymphomas).||
2133|050|B|||
2133|051|H|HOW TO USE:  This medication is given by injection into a vein by||
2133|052|H|a health care professional. This medication is given as directed||
2133|053|H|by your doctor, usually continuously for 7 days in a row. The||
2133|054|H|dosage is based on your weight and response to treatment.||
2133|055|H|   Avoid getting the medication on the skin or in the eyes,||
2133|056|H|mouth, or nose. If you do get the medication in those areas,||
2133|057|H|flush with plenty of water and tell your doctor right away.||
2133|058|B|||
2133|059|S|SIDE EFFECTS:  See also Warning section.||
2133|060|S|   Nausea, vomiting, dizziness, headache, cough, diarrhea,||
2133|061|S|joint/muscle pain, trouble sleeping, stomach/abdominal pain,||
2133|062|S|constipation, or pain/swelling/redness at injection site may||
2133|063|S|occur. If any of these effects last or get worse, tell your||
2133|064|S|doctor or pharmacist promptly.||
2133|065|S|   People using this medication may have serious side effects.||
2133|066|S|However, you have been prescribed this drug because your doctor||
2133|067|S|has judged that the benefit to you is greater than the risk of||
2133|068|S|side effects. Careful monitoring by your doctor may decrease your||
2133|069|S|risk.||
2133|070|S|   Tell your doctor right away if you have any serious side||
2133|071|S|effects, including: pain/swelling/redness of arms or legs,||
2133|072|S|shortness of breath.||
2133|073|S|   A very serious allergic reaction to this drug is rare.||
2133|074|S|However, get medical help right away if you notice any symptoms||
2133|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2133|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2133|077|S|breathing.||
2133|078|S|   Cladribine can commonly cause a mild rash that is usually not||
2133|079|S|serious. However, you may not be able to tell it apart from a||
2133|080|S|rare rash that could be a sign of a severe allergic reaction. Get||
2133|081|S|medical help right away if you develop any rash.||
2133|082|S|   This is not a complete list of possible side effects. If you||
2133|083|S|notice other effects not listed above, contact your doctor or||
2133|084|S|pharmacist.||
2133|085|S|   In the US -||
2133|086|S|   Call your doctor for medical advice about side effects. You||
2133|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2133|088|S|www.fda.gov/medwatch.||
2133|089|S|   In Canada - Call your doctor for medical advice about side||
2133|090|S|effects. You may report side effects to Health Canada at||
2133|091|S|1-866-234-2345.||
2133|092|B|||
2133|093|P|PRECAUTIONS:  Before using cladribine, tell your doctor or||
2133|094|P|pharmacist if you are allergic to it; or if you have any other||
2133|095|P|allergies. This product may contain inactive ingredients, which||
2133|096|P|can cause allergic reactions or other problems. Talk to your||
2133|097|P|pharmacist for more details.||
2133|098|P|   Before using this medication, tell your doctor or pharmacist||
2133|099|P|your medical history, especially of: kidney disease, liver||
2133|100|P|disease, nerve/muscle disorder, blood/bone marrow disorder,||
2133|101|P|recent/current infections.||
2133|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2133|103|P|can make you more dizzy. Do not drive, use machinery, or do||
2133|104|P|anything that needs alertness until you can do it safely. Limit||
2133|105|P|alcoholic beverages. Talk to your doctor if you are using||
2133|106|P|marijuana (cannabis).||
2133|107|P|   Before having surgery, tell your doctor or dentist about all||
2133|108|P|the products you use (including prescription drugs,||
2133|109|P|nonprescription drugs, and herbal products).||
2133|110|P|   Tell your health care professional that you are using||
2133|111|P|cladribine before having any immunizations/vaccinations. Avoid||
2133|112|P|contact with people who have recently received live vaccines||
2133|113|P|(such as flu vaccine inhaled through the nose).||
2133|114|P|   Cladribine can make you more likely to get infections or may||
2133|115|P|make current infections worse. Stay away from anyone who has an||
2133|116|P|infection that may easily spread (such as chickenpox, COVID-19,||
2133|117|P|measles, flu). Talk to your doctor if you have been exposed to an||
2133|118|P|infection or for more details.||
2133|119|P|   To lower your risk of getting cut, bruised, or injured, use||
2133|120|P|caution with sharp objects like razors and nail cutters, and||
2133|121|P|avoid activities such as contact sports.||
2133|122|P|   Tell your doctor if you are pregnant or plan to become||
2133|123|P|pregnant. You should not become pregnant while using cladribine.||
2133|124|P|Cladribine may harm an unborn baby. Ask about reliable forms of||
2133|125|P|birth control while using this medication. If you become||
2133|126|P|pregnant, talk to your doctor right away about the risks and||
2133|127|P|benefits of this medication.||
2133|128|P|   This drug passes into breast milk. Because of the possible||
2133|129|P|risk to the infant, breastfeeding is not recommended while using||
2133|130|P|this drug. Consult your doctor before breastfeeding.||
2133|131|B|||
2133|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2133|133|I|medications work or increase your risk for serious side effects.||
2133|134|I|This document does not contain all possible drug interactions.||
2133|135|I|Keep a list of all the products you use (including||
2133|136|I|prescription/nonprescription drugs and herbal products) and share||
2133|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
2133|138|I|the dosage of any medicines without your doctor's approval.||
2133|139|I|   Some products that may interact with this drug include: other||
2133|140|I|drugs that weaken the immune system/increase the risk of||
2133|141|I|infection (such as cyclosporine, natalizumab, rituximab, drugs to||
2133|142|I|treat cancer like irinotecan), other drugs that worsen kidney||
2133|143|I|problems (including NSAIDs such as ibuprofen).||
2133|144|B|||
2133|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2133|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2133|147|O|poison control center right away. US residents can call||
2133|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2133|149|O|Symptoms of overdose may include: weakness/numbness/tingling in||
2133|150|O|your hands/feet, inability to move your arms/legs, change in the||
2133|151|O|amount of urine, signs of infection (such as sore throat that||
2133|152|O|doesn't go away, fever), easy bruising/bleeding, unusual||
2133|153|O|tiredness, fast/pounding heartbeat.||
2133|154|B|||
2133|155|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2133|156|N|hemoglobin, platelets, kidney/liver function) should be done||
2133|157|N|while you are using this medication. Keep all medical and lab||
2133|158|N|appointments. Consult your doctor for more details.||
2133|159|B|||
2133|160|D|MISSED DOSE:  It is important to get each dose of this medication||
2133|161|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2133|162|D|right away for a new dosing schedule.||
2133|163|B|||
2133|164|R|STORAGE:  Consult the product instructions and your pharmacist||
2133|165|R|for storage details. Keep all medications away from children and||
2133|166|R|pets.||
2133|167|R|   Do not flush medications down the toilet or pour them into a||
2133|168|R|drain unless instructed to do so. Properly discard this product||
2133|169|R|when it is expired or no longer needed. Consult your pharmacist||
2133|170|R|or local waste disposal company.||
2133|171|B|||
2133|172|M|MEDICAL ALERT:  Your condition can cause complications in a||
2133|173|M|medical emergency. For information about enrolling in MedicAlert,||
2133|174|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2133|175|B|||
2133|176|A|Information last revised September 2025.||
2133|177|A|Copyright(c) 2025 First Databank, Inc.||
2133|178|B|||
2134|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2134|002|Z|does NOT have all possible information about this product. This||
2134|003|Z|information does not assure that this product is safe, effective,||
2134|004|Z|or appropriate for you. This information is not individual||
2134|005|Z|medical advice and does not substitute for the advice of your||
2134|006|Z|health care professional. Always ask your health care||
2134|007|Z|professional for complete information about this product and your||
2134|008|Z|specific health needs.||
2134|009|B|||
2134|010|T|CARBOPLATIN - INJECTION||
2134|011|F|(CAR-bow-plah-tin)||
2134|012|B|||
2134|013|C|COMMON BRAND NAME(S): Paraplatin||
2134|014|B|||
2134|015|W|WARNING:  Carboplatin can cause severe blood disorders (such as||
2134|016|W|anemia, bone marrow suppression) that can result in infection and||
2134|017|W|bleeding problems. Your risk of developing these problems||
2134|018|W|increases with higher doses or longer treatment with carboplatin.||
2134|019|W|Also, an unlikely but very serious allergic reaction to this drug||
2134|020|W|may occur within minutes of receiving a dose. Tell your doctor||
2134|021|W|right away if you develop any of the following symptoms: easy||
2134|022|W|bruising/bleeding, signs of infection (such as sore throat that||
2134|023|W|doesn't go away, fever, chills), unusual tiredness, rash,||
2134|024|W|itching, swelling, severe dizziness, or trouble breathing.||
2134|025|W|   Vomiting is a common side effect of this medication. See the||
2134|026|W|Side Effects section for more information.||
2134|027|B|||
2134|028|U|USES:  Carboplatin is used to treat various types of cancer. It||
2134|029|U|is a chemotherapy drug that contains platinum. It is used to slow||
2134|030|U|or stop cancer cell growth.||
2134|031|B|||
2134|032|H|HOW TO USE:  Carboplatin is usually given by infusion into a vein||
2134|033|H|over at least 15 minutes by a healthcare professional.||
2134|034|H|   The dosage is based on your medical condition, body size, and||
2134|035|H|response to treatment. In general, courses of carboplatin||
2134|036|H|treatment should not be given more often than once every 4 weeks.||
2134|037|H|Consult your doctor or pharmacist for more details.||
2134|038|B|||
2134|039|S|SIDE EFFECTS:  Stomach pain, body aches/pain, diarrhea,||
2134|040|S|constipation, weakness, nausea, and vomiting may occur. Nausea||
2134|041|S|and vomiting can be severe in some patients but usually go away||
2134|042|S|within 24 hours of treatment. Drug therapy may be needed to||
2134|043|S|prevent or relieve nausea and vomiting. Not eating before your||
2134|044|S|treatment may help relieve vomiting. Changes in diet such as||
2134|045|S|eating several small meals or limiting activity may help lessen||
2134|046|S|some of these effects. If any of these effects last or get worse,||
2134|047|S|tell your doctor or pharmacist promptly.||
2134|048|S|   Temporary hair loss may occur. Normal hair growth should||
2134|049|S|return after treatment has ended.||
2134|050|S|   Remember that this medication has been prescribed because your||
2134|051|S|doctor has judged that the benefit to you is greater than the||
2134|052|S|risk of side effects. Many people using this medication do not||
2134|053|S|have serious side effects.||
2134|054|S|   Tell your doctor right away if you have any serious side||
2134|055|S|effects, including: numbness or tingling in the hands/feet, mouth||
2134|056|S|sores, yellowing eyes/skin, dark urine, unusual tiredness, signs||
2134|057|S|of kidney problems (such as change in the amount of urine),||
2134|058|S|pain/swelling/redness at the injection site, hearing problems||
2134|059|S|(such as ringing in the ears, hearing loss), easy||
2134|060|S|bruising/bleeding, blood in the urine, black/bloody stools,||
2134|061|S|fast/irregular heartbeat.||
2134|062|S|   Rarely, temporary vision loss may occur with high doses of||
2134|063|S|carboplatin. Normal vision usually returns within several weeks||
2134|064|S|after the end of treatment. Consult your doctor or pharmacist for||
2134|065|S|more details and report this side effect right away if it occurs.||
2134|066|S|   This medication can lower your body's ability to fight an||
2134|067|S|infection. Tell your doctor right away if you develop any signs||
2134|068|S|of an infection (such as sore throat that doesn't go away, fever,||
2134|069|S|chills).||
2134|070|S|   A very serious allergic reaction to this drug is rare.||
2134|071|S|However, get medical help right away if you notice any symptoms||
2134|072|S|of a serious allergic reaction, including: rash, itching/swelling||
2134|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2134|074|S|breathing.||
2134|075|S|   This is not a complete list of possible side effects. If you||
2134|076|S|notice other effects not listed above, contact your doctor or||
2134|077|S|pharmacist.||
2134|078|S|   In the US -||
2134|079|S|   Call your doctor for medical advice about side effects. You||
2134|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2134|081|S|www.fda.gov/medwatch.||
2134|082|S|   In Canada - Call your doctor for medical advice about side||
2134|083|S|effects. You may report side effects to Health Canada at||
2134|084|S|1-866-234-2345.||
2134|085|B|||
2134|086|P|PRECAUTIONS:  Before using carboplatin, tell your doctor or||
2134|087|P|pharmacist if you are allergic to it, or to cisplatin; or if you||
2134|088|P|have any other allergies. This product may contain inactive||
2134|089|P|ingredients, which can cause allergic reactions or other||
2134|090|P|problems. Talk to your pharmacist for more details.||
2134|091|P|   Before using this medication, tell your doctor or pharmacist||
2134|092|P|your medical history, especially of: decreased bone marrow||
2134|093|P|function/blood cell disorders (such as anemia, leukopenia,||
2134|094|P|thrombocytopenia), kidney problems, mineral imbalance (low blood||
2134|095|P|levels of sodium, potassium, magnesium, calcium).||
2134|096|P|   Do not have immunizations/vaccinations without the consent of||
2134|097|P|your doctor, and avoid contact with people who have recently||
2134|098|P|received oral polio vaccine.||
2134|099|P|   Use caution with sharp objects like safety razors or nail||
2134|100|P|cutters and avoid activities such as contact sports to lower the||
2134|101|P|chance of getting cut, bruised or injured.||
2134|102|P|   Wash your hands well to prevent the spread of infections.||
2134|103|P|   Older adults may be more sensitive to the side effects of this||
2134|104|P|drug, especially to bleeding problems and numbness/tingling of||
2134|105|P|the hands/feet.||
2134|106|P|   Children may be at greater risk for hearing loss when||
2134|107|P|carboplatin is used at higher-than-recommended doses in||
2134|108|P|combination with other medications that may affect hearing.||
2134|109|P|   This medication can affect sperm production in men. Men should||
2134|110|P|use a reliable form of birth control during treatment and for||
2134|111|P|some time afterwards. Consult your doctor for more details.||
2134|112|P|   Tell your doctor if you are pregnant or plan to become||
2134|113|P|pregnant. You should not become pregnant while using carboplatin.||
2134|114|P|Carboplatin may harm an unborn baby. Ask about reliable forms of||
2134|115|P|birth control while using this medication and for some time after||
2134|116|P|the last dose. If you become pregnant, talk to your doctor right||
2134|117|P|away about the risks and benefits of this medication.||
2134|118|P|   It is unknown if this drug passes into breast milk. Because of||
2134|119|P|the possible risk to the infant, breastfeeding is not recommended||
2134|120|P|while using this drug. Consult your doctor before breastfeeding.||
2134|121|B|||
2134|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2134|123|I|medications work or increase your risk for serious side effects.||
2134|124|I|This document does not contain all possible drug interactions.||
2134|125|I|Keep a list of all the products you use (including||
2134|126|I|prescription/nonprescription drugs and herbal products) and share||
2134|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
2134|128|I|the dosage of any medicines without your doctor's approval.||
2134|129|I|   Some products that may interact with this drug include:||
2134|130|I|aminoglycoside antibiotics (such as gentamicin, neomycin),||
2134|131|I|amphotericin B, certain anti-seizure medications (hydantoins such||
2134|132|I|as phenytoin).||
2134|133|B|||
2134|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2134|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2134|136|O|poison control center right away. US residents can call||
2134|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2134|138|B|||
2134|139|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2134|140|N|kidney function, blood mineral levels) should be done while you||
2134|141|N|are using this medication. Keep all medical and lab appointments.||
2134|142|N|Consult your doctor for more details.||
2134|143|B|||
2134|144|D|MISSED DOSE:  It is important to get each dose of this medication||
2134|145|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2134|146|D|right away for a new dosing schedule.||
2134|147|B|||
2134|148|R|STORAGE:  Not applicable. This medication is given in a clinic||
2134|149|R|and will not be stored at home.||
2134|150|B|||
2134|151|M|MEDICAL ALERT:  Your condition can cause complications in a||
2134|152|M|medical emergency. For information about enrolling in MedicAlert,||
2134|153|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2134|154|B|||
2134|155|A|Information last revised October 2025.||
2134|156|A|Copyright(c) 2025 First Databank, Inc.||
2134|157|B|||
2135|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2135|002|Z|does NOT have all possible information about this product. This||
2135|003|Z|information does not assure that this product is safe, effective,||
2135|004|Z|or appropriate for you. This information is not individual||
2135|005|Z|medical advice and does not substitute for the advice of your||
2135|006|Z|health care professional. Always ask your health care||
2135|007|Z|professional for complete information about this product and your||
2135|008|Z|specific health needs.||
2135|009|B|||
2135|010|T|THIOTEPA - INJECTION||
2135|011|F|(thigh-oh-TEP-uh)||
2135|012|B|||
2135|013|C|COMMON BRAND NAME(S): Tepadina, Tepylute, Thioplex||
2135|014|B|||
2135|015|W|WARNING:  This medication decreases bone marrow function, an||
2135|016|W|effect that may lead to a low number of blood cells such as red||
2135|017|W|cells, white cells, and platelets. This effect can cause anemia,||
2135|018|W|decrease your body's ability to fight an infection, or cause easy||
2135|019|W|bruising/bleeding. Your doctor will monitor your labs while you||
2135|020|W|are using this medication. Tell your doctor right away if you||
2135|021|W|develop any of the following symptoms: unusual tiredness, pale||
2135|022|W|skin, signs of infection (such as sore throat that doesn't go||
2135|023|W|away, fever, chills), easy bruising/bleeding.||
2135|024|W|   Although thiotepa is used to treat cancer, in some people this||
2135|025|W|medication may also increase the risk of developing another form||
2135|026|W|of cancer. Talk to your doctor about the risks and benefits of||
2135|027|W|this medication.||
2135|028|B|||
2135|029|U|USES:  Thiotepa is used to treat cancer. It works by slowing or||
2135|030|U|stopping the growth of cancer cells. Some brands may also be||
2135|031|U|given into the bladder to treat bladder cancer or used along with||
2135|032|U|other medications to prevent rejection of a stem cell transplant.||
2135|033|B|||
2135|034|H|HOW TO USE:  This medication is given by injection into a vein by||
2135|035|H|a health care professional. Sometimes, thiotepa is injected||
2135|036|H|directly into the tumor. Tell your doctor or nurse right away if||
2135|037|H|you experience pain, burning, or redness at the injection site.||
2135|038|H|   For treatment of bladder cancer, thiotepa is usually given||
2135|039|H|into the bladder through a tube (catheter). Your doctor may||
2135|040|H|direct you to limit fluids for 8 to 12 hours before the||
2135|041|H|medication is given. The solution is usually left in place for 2||
2135|042|H|hours and then drained out through the bladder tube. Your doctor||
2135|043|H|may direct you to change positions every 15 minutes while the||
2135|044|H|solution is in your bladder to make sure the solution treats all||
2135|045|H|parts of your bladder.||
2135|046|H|   With certain uses of this drug (such as preventing rejection||
2135|047|H|of stem cell transplant), skin problems may occur since the drug||
2135|048|H|may come through your skin when you sweat. Follow your doctor's||
2135|049|H|instructions on what precautions to take and how often you would||
2135|050|H|need to shower/bathe and change your bandages/dressings.||
2135|051|H|   The dosage is based on your weight, labs, medical condition,||
2135|052|H|and response to treatment. For the prevention of stem cell||
2135|053|H|transplant rejection, the dosage may also be based on body size.||
2135|054|H|   Learn how to handle, use, and discard chemotherapy and medical||
2135|055|H|supplies safely. Consult your pharmacist. Wear gloves and wash||
2135|056|H|your hands carefully after handling this drug. Avoid getting this||
2135|057|H|medication in your eyes or on your skin. If the medication gets||
2135|058|H|in your eye, wash the affected eye(s) well with water and contact||
2135|059|H|your doctor. If the medication gets on your skin, wash the area||
2135|060|H|well with soap and water.||
2135|061|B|||
2135|062|S|SIDE EFFECTS:  See also Warning section.||
2135|063|S|   Pain/redness at the injection site, dizziness, headache,||
2135|064|S|blurred vision, nausea, vomiting, or loss of appetite may occur.||
2135|065|S|Changes in diet such as eating several small meals or limiting||
2135|066|S|activity may help lessen some of these effects. In some cases,||
2135|067|S|drug treatment may be necessary to prevent or relieve nausea and||
2135|068|S|vomiting. If any of these effects last or get worse, tell your||
2135|069|S|doctor or pharmacist promptly.||
2135|070|S|   Temporary hair loss is another common side effect. Normal hair||
2135|071|S|growth should return after treatment has ended.||
2135|072|S|   People using this medication may have serious side effects.||
2135|073|S|However, you have been prescribed this drug because your doctor||
2135|074|S|has judged that the benefit to you is greater than the risk of||
2135|075|S|side effects. Careful monitoring by your doctor may decrease your||
2135|076|S|risk.||
2135|077|S|   Pain or sores in the mouth and throat may occur. Brush your||
2135|078|S|teeth carefully/gently, avoid using mouthwash that contains||
2135|079|S|alcohol, and rinse your mouth often with cool water mixed with||
2135|080|S|baking soda or salt. It may also be best to eat soft, moist||
2135|081|S|foods.||
2135|082|S|   Tell your doctor right away if you have any serious side||
2135|083|S|effects, including: bloody/black/tarry stools, coughing up blood,||
2135|084|S|vomit that is bloody or looks like coffee grounds, fast/irregular||
2135|085|S|heartbeat, lower back/side pain, painful/difficult urination,||
2135|086|S|signs of kidney problems (such as change in the amount of urine),||
2135|087|S|pink/dark urine, seizures, signs of skin problems (such as||
2135|088|S|changes in skin color, skin peeling/blisters), signs of liver||
2135|089|S|problems (such as nausea/vomiting that doesn't stop,||
2135|090|S|stomach/abdominal pain, yellowing of eyes/skin), mental/mood||
2135|091|S|changes (such as confusion, hallucinations, changes in behavior).||
2135|092|S|   A very serious allergic reaction to this drug is rare.||
2135|093|S|However, get medical help right away if you notice any symptoms||
2135|094|S|of a serious allergic reaction, including: rash, itching/swelling||
2135|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2135|096|S|breathing.||
2135|097|S|   This is not a complete list of possible side effects. If you||
2135|098|S|notice other effects not listed above, contact your doctor or||
2135|099|S|pharmacist.||
2135|100|S|   In the US -||
2135|101|S|   Call your doctor for medical advice about side effects. You||
2135|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2135|103|S|www.fda.gov/medwatch.||
2135|104|S|   In Canada - Call your doctor for medical advice about side||
2135|105|S|effects. You may report side effects to Health Canada at||
2135|106|S|1-866-234-2345.||
2135|107|B|||
2135|108|P|PRECAUTIONS:  Before using thiotepa, tell your doctor or||
2135|109|P|pharmacist if you are allergic to it; or if you have any other||
2135|110|P|allergies. This product may contain inactive ingredients, which||
2135|111|P|can cause allergic reactions or other problems. Talk to your||
2135|112|P|pharmacist for more details.||
2135|113|P|   Before using this medication, tell your doctor or pharmacist||
2135|114|P|your medical history, especially: bone marrow problems (such as||
2135|115|P|low white blood cell count/platelets from previous||
2135|116|P|chemotherapy/radiation treatment), heart problems (such as heart||
2135|117|P|failure, heart attack), kidney disease, liver disease.||
2135|118|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
2135|119|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
2135|120|P|use machinery, or do anything that needs alertness or clear||
2135|121|P|vision until you can do it safely. Limit alcoholic beverages.||
2135|122|P|Talk to your doctor if you are using marijuana (cannabis).||
2135|123|P|   Thiotepa can make you more likely to get infections or may||
2135|124|P|make current infections worse. Stay away from anyone who has an||
2135|125|P|infection that may easily spread (such as chickenpox, COVID-19,||
2135|126|P|measles, flu). Talk to your doctor if you have been exposed to an||
2135|127|P|infection or for more details.||
2135|128|P|   Tell your health care professional that you are using thiotepa||
2135|129|P|before having any immunizations/vaccinations. Avoid contact with||
2135|130|P|people who have recently received live vaccines (such as flu||
2135|131|P|vaccine inhaled through the nose).||
2135|132|P|   To lower your risk of getting cut, bruised, or injured, use||
2135|133|P|caution with sharp objects like razors and nail cutters, and||
2135|134|P|avoid activities such as contact sports.||
2135|135|P|   Before having surgery, tell your doctor or dentist about all||
2135|136|P|the products you use (including prescription drugs,||
2135|137|P|nonprescription drugs, and herbal products).||
2135|138|P|   This medication can affect fertility in males. Ask your doctor||
2135|139|P|for more details.||
2135|140|P|   Tell your doctor if you are pregnant or plan to become||
2135|141|P|pregnant. You should not become pregnant while using thiotepa.||
2135|142|P|Thiotepa may harm an unborn baby. Your doctor should order a||
2135|143|P|pregnancy test before you start this medication. Women using this||
2135|144|P|medication should ask about reliable forms of birth control||
2135|145|P|during treatment and for 6 months after the last dose. Men using||
2135|146|P|this medication should ask about reliable forms of birth control||
2135|147|P|during treatment and for 1 year after the last dose. If you or||
2135|148|P|your partner becomes pregnant, talk to your doctor right away||
2135|149|P|about the risks and benefits of this medication.||
2135|150|P|   It is unknown if this medication passes into breast milk.||
2135|151|P|Because of the possible risk to the infant, breastfeeding is not||
2135|152|P|recommended while using this medication and for some time after||
2135|153|P|the last dose. Consult your doctor before breastfeeding.||
2135|154|B|||
2135|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2135|156|I|medications work or increase your risk for serious side effects.||
2135|157|I|This document does not contain all possible drug interactions.||
2135|158|I|Keep a list of all the products you use (including||
2135|159|I|prescription/nonprescription drugs and herbal products) and share||
2135|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
2135|161|I|the dosage of any medicines without your doctor's approval.||
2135|162|B|||
2135|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2135|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2135|165|O|poison control center right away. US residents can call||
2135|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2135|167|B|||
2135|168|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2135|169|N|kidney/liver function) should be done while you are using this||
2135|170|N|medication and for several weeks after your last dose. Keep all||
2135|171|N|medical and lab appointments. Consult your doctor for more||
2135|172|N|details.||
2135|173|B|||
2135|174|D|MISSED DOSE:  It is important to get each dose of this medication||
2135|175|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2135|176|D|right away for a new dosing schedule.||
2135|177|B|||
2135|178|R|STORAGE:  Not applicable. This medication is given in a clinic||
2135|179|R|and will not be stored at home.||
2135|180|B|||
2135|181|M|MEDICAL ALERT:  Your condition can cause complications in a||
2135|182|M|medical emergency. For information about enrolling in MedicAlert,||
2135|183|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2135|184|B|||
2135|185|A|Information last revised May 2025.||
2135|186|A|Copyright(c) 2025 First Databank, Inc.||
2135|187|B|||
2136|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2136|002|Z|does NOT have all possible information about this product. This||
2136|003|Z|information does not assure that this product is safe, effective,||
2136|004|Z|or appropriate for you. This information is not individual||
2136|005|Z|medical advice and does not substitute for the advice of your||
2136|006|Z|health care professional. Always ask your health care||
2136|007|Z|professional for complete information about this product and your||
2136|008|Z|specific health needs.||
2136|009|B|||
2136|010|T|CYPROTERONE - ORAL||
2136|011|F|(sye-PRO-ter-own)||
2136|012|B|||
2136|013|U|USES:  This medication is used to treat advanced prostate cancer.||
2136|014|U|It is not a cure. Cyproterone is used to control flare-up of||
2136|015|U|disease symptoms or hot flashes caused by other treatments. It||
2136|016|U|also helps slow or stop the spread of prostate cancer by blocking||
2136|017|U|the effects of testosterone and by reducing the amount of||
2136|018|U|testosterone that the body makes. Testosterone, a natural||
2136|019|U|hormone, helps prostate cancer to grow and spread. Cyproterone is||
2136|020|U|a type of progestin hormone.||
2136|021|U|   Cyproterone should not be used by children.||
2136|022|B|||
2136|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
2136|024|H|doctor, usually 2 to 3 times a day after meals. The dosage is||
2136|025|H|based on your medical condition and response to treatment.||
2136|026|H|   Take this medication regularly to get the most benefit from||
2136|027|H|it. To help you remember, take it at the same times each day.||
2136|028|H|   Tell your doctor if your condition does not get better or if||
2136|029|H|it gets worse (such as urination becomes more difficult, bone||
2136|030|H|pain increases).||
2136|031|H|   Since this drug can be absorbed through the skin and lungs,||
2136|032|H|women who are pregnant or who may become pregnant should not||
2136|033|H|handle this medication or breathe the dust from the tablets.||
2136|034|B|||
2136|035|S|SIDE EFFECTS:  Tiredness is common during the first few weeks of||
2136|036|S|treatment but usually improves by the third month. Dry skin,||
2136|037|S|temporary loss of patches of body hair, weakness, dizziness,||
2136|038|S|headache, nausea, stomach upset, flushing of the face/neck,||
2136|039|S|sweating, decreased sexual interest/ability, and male breast||
2136|040|S|enlargement/tenderness may also occur. If any of these effects||
2136|041|S|last or get worse, tell your doctor or pharmacist promptly.||
2136|042|S|   Remember that this medication has been prescribed because your||
2136|043|S|doctor has judged that the benefit to you is greater than the||
2136|044|S|risk of side effects. Many people using this medication do not||
2136|045|S|have serious side effects.||
2136|046|S|   Tell your doctor right away if you have any serious side||
2136|047|S|effects, including: breast lumps, mental/mood changes (such as||
2136|048|S|new/worsening depression), new/worsening bone pain, fast||
2136|049|S|heartbeat, rapid weight change, swelling of the ankles/feet,||
2136|050|S|increased thirst/urination, easy bleeding/bruising, signs of||
2136|051|S|infection (such as sore throat that doesn't go away, fever,||
2136|052|S|chills), signs of liver problems (such as nausea that doesn't||
2136|053|S|stop, vomiting, stomach/abdominal pain, yellowing eyes/skin, dark||
2136|054|S|urine).||
2136|055|S|   This medication may rarely cause blood clots. Get medical help||
2136|056|S|right away if any of these very serious side effects occur:||
2136|057|S|pain/swelling/warmth in the groin/calf, shortness of breath/rapid||
2136|058|S|breathing, sudden vision changes, confusion, trouble speaking,||
2136|059|S|weakness on one side of the body, sudden/severe headaches,||
2136|060|S|chest/jaw/left arm pain, sudden dizziness/fainting, unusual||
2136|061|S|sweating.||
2136|062|S|   A very serious allergic reaction to this drug is rare.||
2136|063|S|However, get medical help right away if you notice any symptoms||
2136|064|S|of a serious allergic reaction, including: rash, itching/swelling||
2136|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2136|066|S|breathing.||
2136|067|S|   This is not a complete list of possible side effects. If you||
2136|068|S|notice other effects not listed above, contact your doctor or||
2136|069|S|pharmacist.||
2136|070|S|   In the US -||
2136|071|S|   Call your doctor for medical advice about side effects. You||
2136|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2136|073|S|www.fda.gov/medwatch.||
2136|074|S|   In Canada - Call your doctor for medical advice about side||
2136|075|S|effects. You may report side effects to Health Canada at||
2136|076|S|1-866-234-2345.||
2136|077|B|||
2136|078|P|PRECAUTIONS:  Before taking cyproterone, tell your doctor or||
2136|079|P|pharmacist if you are allergic to it; or if you have any other||
2136|080|P|allergies. This product may contain inactive ingredients, which||
2136|081|P|can cause allergic reactions or other problems. Talk to your||
2136|082|P|pharmacist for more details.||
2136|083|P|   Before using this medication, tell your doctor or pharmacist||
2136|084|P|your medical history, especially of: liver disease, kidney||
2136|085|P|disease, depression, blood clots, diabetes, heart disease (such||
2136|086|P|as heart failure, coronary artery disease), high cholesterol/fats||
2136|087|P|in the blood, decreased adrenal gland function, tumor of the||
2136|088|P|coverings of the brain (meningioma).||
2136|089|P|   If you have diabetes, this medication may affect your blood||
2136|090|P|sugar. Check your blood sugar regularly as directed and share the||
2136|091|P|results with your doctor. Tell your doctor right away if you have||
2136|092|P|symptoms of high blood sugar such as increased thirst/urination.||
2136|093|P|Your doctor may need to adjust your diabetes medication, exercise||
2136|094|P|program, or diet.||
2136|095|P|   This drug may make you dizzy or very tired. Alcohol or||
2136|096|P|marijuana (cannabis) can make you more dizzy or tired. Do not||
2136|097|P|drive, use machinery, or do anything that needs alertness until||
2136|098|P|you can do it safely. Avoid alcoholic beverages. Talk to your||
2136|099|P|doctor if you are using marijuana (cannabis). Alcohol may worsen||
2136|100|P|this drug's side effects and may interfere with the way this drug||
2136|101|P|works.||
2136|102|P|   This medication may make you more sensitive to the sun. Limit||
2136|103|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2136|104|P|sunscreen and wear protective clothing when outdoors. Tell your||
2136|105|P|doctor right away if you get sunburned or have skin||
2136|106|P|blisters/redness.||
2136|107|P|   Before having surgery, tell your doctor or dentist about all||
2136|108|P|the products you use (including prescription drugs,||
2136|109|P|nonprescription drugs, and herbal products).||
2136|110|P|   This medication can affect fertility in males. Ask your doctor||
2136|111|P|for more details.||
2136|112|P|   This medication should not be used by women, especially during||
2136|113|P|pregnancy or breastfeeding. It may harm an unborn or||
2136|114|P|breastfeeding baby. Consult your doctor for more details.||
2136|115|B|||
2136|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2136|117|I|medications work or increase your risk for serious side effects.||
2136|118|I|This document does not contain all possible drug interactions.||
2136|119|I|Keep a list of all the products you use (including||
2136|120|I|prescription/nonprescription drugs and herbal products) and share||
2136|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
2136|122|I|the dosage of any medicines without your doctor's approval.||
2136|123|I|   Some products that may interact with this drug are: products||
2136|124|I|containing testosterone.||
2136|125|B|||
2136|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2136|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2136|128|O|poison control center right away. US residents can call||
2136|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2136|130|B|||
2136|131|N|NOTES:  Do not share this medication with others.||
2136|132|N|   Lab and/or medical tests (such as liver function, PSA blood||
2136|133|N|test, blood counts) should be done while you are taking this||
2136|134|N|medication. Keep all medical and lab appointments. Consult your||
2136|135|N|doctor for more details.||
2136|136|B|||
2136|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2136|138|D|remember. If it is near the time of the next dose, skip the||
2136|139|D|missed dose. Take your next dose at the regular time. Do not||
2136|140|D|double the dose to catch up.||
2136|141|B|||
2136|142|R|STORAGE:  Store at room temperature away from light and moisture.||
2136|143|R|Do not store in the bathroom. Keep all medications away from||
2136|144|R|children and pets.||
2136|145|R|   Do not flush medications down the toilet or pour them into a||
2136|146|R|drain unless instructed to do so. Properly discard this product||
2136|147|R|when it is expired or no longer needed. Consult your pharmacist||
2136|148|R|or local waste disposal company.||
2136|149|B|||
2136|150|A|Information last revised November 2024.||
2136|151|A|Copyright(c) 2025 First Databank, Inc.||
2136|152|B|||
2137|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2137|002|Z|does NOT have all possible information about this product. This||
2137|003|Z|information does not assure that this product is safe, effective,||
2137|004|Z|or appropriate for you. This information is not individual||
2137|005|Z|medical advice and does not substitute for the advice of your||
2137|006|Z|health care professional. Always ask your health care||
2137|007|Z|professional for complete information about this product and your||
2137|008|Z|specific health needs.||
2137|009|B|||
2137|010|T|VINORELBINE - INJECTION||
2137|011|F|(vye-nor-ELL-bean)||
2137|012|B|||
2137|013|C|COMMON BRAND NAME(S): Navelbine||
2137|014|B|||
2137|015|W|WARNING:  This medication must be given only by injection into a||
2137|016|W|vein by a trained healthcare professional. Deaths have occurred||
2137|017|W|with medications similar to vinorelbine that were injected into||
2137|018|W|the spine.||
2137|019|W|   Vinorelbine can lower your blood cell counts (bone marrow||
2137|020|W|suppression) and lower your ability to fight an infection. Your||
2137|021|W|doctor will follow your blood counts closely. Tell your doctor||
2137|022|W|right away if you develop any signs of an infection (such as sore||
2137|023|W|throat that doesn't go away, fever, chills).||
2137|024|W|   If this medication accidentally leaks out of your vein into||
2137|025|W|surrounding tissue, the skin and/or muscle may be severely||
2137|026|W|damaged. Tell your doctor right away if you have pain, redness,||
2137|027|W|swelling, or discoloration at the injection site.||
2137|028|B|||
2137|029|U|USES:  Vinorelbine is used to treat various types of cancer. It||
2137|030|U|is a chemotherapy drug that works by slowing or stopping cancer||
2137|031|U|cell growth.||
2137|032|B|||
2137|033|H|HOW TO USE:  Vinorelbine is given by injection only into a vein||
2137|034|H|by a healthcare professional. It is given as directed by your||
2137|035|H|doctor, usually over 6-10 minutes, once a week. The dosage is||
2137|036|H|based on your medical condition, response to treatment, and body||
2137|037|H|size.||
2137|038|H|   If this medication comes into contact with your skin, wash||
2137|039|H|your skin right away and completely with soap and water. If||
2137|040|H|vinorelbine gets into your eyes, flush them right away and||
2137|041|H|completely with water, and contact the doctor.||
2137|042|B|||
2137|043|S|SIDE EFFECTS:  See also Warning section.||
2137|044|S|   Nausea, vomiting, tiredness, constipation, diarrhea,||
2137|045|S|dizziness, muscle aches, joint pain, or irritation at the||
2137|046|S|injection site may occur. If any of these effects last or get||
2137|047|S|worse, notify your doctor or pharmacist promptly.||
2137|048|S|   Temporary hair loss may occur. Normal hair growth should||
2137|049|S|return after treatment has ended.||
2137|050|S|   To prevent constipation, eat dietary fiber, drink enough||
2137|051|S|water, and exercise. Your doctor may prescribe a laxative (such||
2137|052|S|as a stool softener) to help prevent constipation. Ask your||
2137|053|S|doctor or pharmacist which type of laxative is right for you.||
2137|054|S|   People using this medication may have serious side effects.||
2137|055|S|However, you have been prescribed this drug because your doctor||
2137|056|S|has judged that the benefit to you is greater than the risk of||
2137|057|S|side effects. Careful monitoring by your doctor may decrease your||
2137|058|S|risk.||
2137|059|S|   Tell your doctor right away if you have any serious side||
2137|060|S|effects, including: signs of liver disease (such as||
2137|061|S|nausea/vomiting that doesn't stop, loss of appetite,||
2137|062|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2137|063|S|numbness/tingling/pain in the hands or feet, decreased reflexes,||
2137|064|S|mouth sores, easy bruising/bleeding, weakness, shortness of||
2137|065|S|breath, cough, severe constipation, blood in the urine,||
2137|066|S|mental/mood changes.||
2137|067|S|   Get medical help right away if you have any very serious side||
2137|068|S|effects, including: chest pain.||
2137|069|S|   A very serious allergic reaction to this drug is rare.||
2137|070|S|However, get medical help right away if you notice any symptoms||
2137|071|S|of a serious allergic reaction, such as: rash, itching/swelling||
2137|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2137|073|S|breathing.||
2137|074|S|   This is not a complete list of possible side effects. If you||
2137|075|S|notice other effects not listed above, contact your doctor or||
2137|076|S|pharmacist.||
2137|077|S|   In the US -||
2137|078|S|   Call your doctor for medical advice about side effects. You||
2137|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2137|080|S|www.fda.gov/medwatch.||
2137|081|S|   In Canada - Call your doctor for medical advice about side||
2137|082|S|effects. You may report side effects to Health Canada at||
2137|083|S|1-866-234-2345.||
2137|084|B|||
2137|085|P|PRECAUTIONS:  Before using vinorelbine, tell your doctor or||
2137|086|P|pharmacist if you are allergic to it; or if you have any other||
2137|087|P|allergies. This product may contain inactive ingredients, which||
2137|088|P|can cause allergic reactions or other problems. Talk to your||
2137|089|P|pharmacist for more details.||
2137|090|P|   Before using this medication, tell your doctor or pharmacist||
2137|091|P|your medical history, especially of: decreased bone marrow||
2137|092|P|function/blood cell disorders (such as anemia, leukopenia,||
2137|093|P|thrombocytopenia), liver disease, numbness/tingling of the hands||
2137|094|P|or feet, blockage of the stomach/intestines (such as obstruction,||
2137|095|P|paralytic ileus), heart disease.||
2137|096|P|   Vinorelbine can sometimes cause a serious skin reaction that||
2137|097|P|looks like a severe sunburn when given after radiation treatment||
2137|098|P|(radiation recall). The reaction usually develops on the skin||
2137|099|P|area previously treated with radiation within days to months||
2137|100|P|after vinorelbine treatment. Throat problems can also be part of||
2137|101|P|radiation recall with vinorelbine. Tell your doctor right away if||
2137|102|P|you develop skin redness/tenderness/swelling/peeling/blisters or||
2137|103|P|painful/difficult swallowing. Your doctor may prescribe||
2137|104|P|medication to treat your symptoms. If you develop a skin||
2137|105|P|reaction, avoid prolonged sun exposure, tanning booths and||
2137|106|P|sunlamps. Use a sunscreen and wear protective clothing when||
2137|107|P|outdoors.||
2137|108|P|   Do not have immunizations/vaccinations without the consent of||
2137|109|P|your doctor and avoid contact with people who have recently||
2137|110|P|received oral polio vaccine.||
2137|111|P|   Use caution with sharp objects like safety razors or nail||
2137|112|P|cutters, and avoid activities such as contact sports to lower the||
2137|113|P|chance of getting cut, bruised or injured.||
2137|114|P|   Wash your hands well to prevent the spread of infections.||
2137|115|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2137|116|P|can make you more dizzy. Do not drive, use machinery, or do||
2137|117|P|anything that needs alertness until you can do it safely. Limit||
2137|118|P|alcoholic beverages. Talk to your doctor if you are using||
2137|119|P|marijuana (cannabis).||
2137|120|P|   This medication can affect fertility in males. Ask your doctor||
2137|121|P|for more details.||
2137|122|P|   Tell your doctor if you are pregnant or plan to become||
2137|123|P|pregnant. You should not become pregnant while using vinorelbine.||
2137|124|P|Vinorelbine may harm an unborn baby. Women using this medication||
2137|125|P|should ask about reliable forms of birth control during treatment||
2137|126|P|and for 6 months after the last dose. Men using this medication||
2137|127|P|should ask about reliable forms of birth control during treatment||
2137|128|P|and for 3 months after the last dose. If you or your partner||
2137|129|P|becomes pregnant, talk to your doctor right away about the risks||
2137|130|P|and benefits of this medication.||
2137|131|P|   It is unknown if this medication passes into breast milk.||
2137|132|P|Because of the possible risk to the infant, breastfeeding is not||
2137|133|P|recommended while using this medication and for 9 days after the||
2137|134|P|last dose. Consult your doctor before breastfeeding.||
2137|135|B|||
2137|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2137|137|I|medications work or increase your risk for serious side effects.||
2137|138|I|This document does not contain all possible drug interactions.||
2137|139|I|Keep a list of all the products you use (including||
2137|140|I|prescription/nonprescription drugs and herbal products) and share||
2137|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
2137|142|I|the dosage of any medicines without your doctor's approval.||
2137|143|I|   A product that may interact with this drug is: mitomycin.||
2137|144|I|   Other medications can affect the removal of vinorelbine from||
2137|145|I|your body, which may affect how vinorelbine works. Examples||
2137|146|I|include azole antifungals (such as itraconazole), macrolide||
2137|147|I|antibiotics (such as erythromycin), rifamycins (such as||
2137|148|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
2137|149|I|as carbamazepine), among others.||
2137|150|B|||
2137|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2137|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2137|153|O|poison control center right away. US residents can call||
2137|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2137|155|B|||
2137|156|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2137|157|N|liver function) should be done while you are using this||
2137|158|N|medication. Keep all medical and lab appointments. Consult your||
2137|159|N|doctor for more details.||
2137|160|B|||
2137|161|D|MISSED DOSE:  It is important to get each dose of this medication||
2137|162|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2137|163|D|right away for a new dosing schedule.||
2137|164|B|||
2137|165|R|STORAGE:  Not applicable. This medication is given in a clinic||
2137|166|R|and will not be stored at home.||
2137|167|B|||
2137|168|M|MEDICAL ALERT:  Your condition can cause complications in a||
2137|169|M|medical emergency. For information about enrolling in MedicAlert,||
2137|170|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2137|171|B|||
2137|172|A|Information last revised April 2025.||
2137|173|A|Copyright(c) 2025 First Databank, Inc.||
2137|174|B|||
2139|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2139|002|Z|does NOT have all possible information about this product. This||
2139|003|Z|information does not assure that this product is safe, effective,||
2139|004|Z|or appropriate for you. This information is not individual||
2139|005|Z|medical advice and does not substitute for the advice of your||
2139|006|Z|health care professional. Always ask your health care||
2139|007|Z|professional for complete information about this product and your||
2139|008|Z|specific health needs.||
2139|009|B|||
2139|010|T|PITOLISANT - ORAL||
2139|011|F|(pi-TOL-i-sant)||
2139|012|B|||
2139|013|C|COMMON BRAND NAME(S): Wakix||
2139|014|B|||
2139|015|U|USES:  Pitolisant is used to treat narcolepsy, a condition that||
2139|016|U|causes severe daytime sleepiness. It can decrease daytime||
2139|017|U|sleepiness and also reduce the number of sudden short attacks of||
2139|018|U|weak/paralyzed muscles (known as cataplexy) that can occur in||
2139|019|U|people with narcolepsy. Pitolisant works by increasing histamine||
2139|020|U|levels in the brain to make you more awake.||
2139|021|B|||
2139|022|H|HOW TO USE:  Take this medication by mouth with or without food||
2139|023|H|as directed by your doctor, usually once daily in the morning||
2139|024|H|when you wake up. Take this medication regularly to get the most||
2139|025|H|benefit from it. To help you remember, take it at the same time||
2139|026|H|each day.||
2139|027|H|   The dosage is based on your medical condition, response to||
2139|028|H|treatment, and other medications you may be taking. Children's||
2139|029|H|dosage may also be based on weight. Be sure to tell your doctor||
2139|030|H|and pharmacist about all the products you use (including||
2139|031|H|prescription drugs, nonprescription drugs, and herbal products).||
2139|032|H|   To reduce your risk of side effects, your doctor may direct||
2139|033|H|you to start this medication at a low dose and gradually increase||
2139|034|H|your dose. Follow your doctor's instructions carefully. Do not||
2139|035|H|increase your dose or use this drug more often or for longer than||
2139|036|H|prescribed. Your condition will not improve any faster, and your||
2139|037|H|risk of side effects will increase.||
2139|038|H|   It may take up to 2 months for some people to notice an||
2139|039|H|improvement in their daytime sleepiness. Tell your doctor if your||
2139|040|H|condition does not get better or if it gets worse.||
2139|041|B|||
2139|042|S|SIDE EFFECTS:  Nausea, nervousness, or trouble sleeping may||
2139|043|S|occur. If any of these effects last or get worse, tell your||
2139|044|S|doctor or pharmacist promptly.||
2139|045|S|   Remember that this medication has been prescribed because your||
2139|046|S|doctor has judged that the benefit to you is greater than the||
2139|047|S|risk of side effects. Many people using this medication do not||
2139|048|S|have serious side effects.||
2139|049|S|   Tell your doctor right away if you have any serious side||
2139|050|S|effects, including: mental/mood changes (such as hallucinations).||
2139|051|S|   Get medical help right away if you have any very serious side||
2139|052|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2139|053|S|fainting.||
2139|054|S|   A very serious allergic reaction to this drug is rare.||
2139|055|S|However, get medical help right away if you notice any symptoms||
2139|056|S|of a serious allergic reaction, including: rash, itching/swelling||
2139|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2139|058|S|breathing.||
2139|059|S|   This is not a complete list of possible side effects. If you||
2139|060|S|notice other effects not listed above, contact your doctor or||
2139|061|S|pharmacist.||
2139|062|S|   In the US -||
2139|063|S|   Call your doctor for medical advice about side effects. You||
2139|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2139|065|S|www.fda.gov/medwatch.||
2139|066|S|   In Canada - Call your doctor for medical advice about side||
2139|067|S|effects. You may report side effects to Health Canada at||
2139|068|S|1-866-234-2345.||
2139|069|B|||
2139|070|P|PRECAUTIONS:  Before taking pitolisant, tell your doctor or||
2139|071|P|pharmacist if you are allergic to it; or if you have any other||
2139|072|P|allergies. This product may contain inactive ingredients, which||
2139|073|P|can cause allergic reactions or other problems. Talk to your||
2139|074|P|pharmacist for more details.||
2139|075|P|   Before using this medication, tell your doctor or pharmacist||
2139|076|P|your medical history, especially of: kidney problems, liver||
2139|077|P|problems.||
2139|078|P|   Pitolisant may cause a condition that affects the heart rhythm||
2139|079|P|(QT prolongation). QT prolongation can rarely cause serious||
2139|080|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2139|081|P|as severe dizziness, fainting) that need medical attention right||
2139|082|P|away.||
2139|083|P|   The risk of QT prolongation may be increased if you have||
2139|084|P|certain medical conditions or are taking other drugs that may||
2139|085|P|cause QT prolongation. Before using pitolisant, tell your doctor||
2139|086|P|or pharmacist of all the drugs you take and if you have any of||
2139|087|P|the following conditions: certain heart problems (heart failure,||
2139|088|P|slow heartbeat, QT prolongation in the EKG), family history of||
2139|089|P|certain heart problems (QT prolongation in the EKG, sudden||
2139|090|P|cardiac death).||
2139|091|P|   Low levels of potassium or magnesium in the blood may also||
2139|092|P|increase your risk of QT prolongation. This risk may increase if||
2139|093|P|you use certain drugs (such as diuretics/"water pills") or if you||
2139|094|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2139|095|P|Talk to your doctor about using pitolisant safely.||
2139|096|P|   Before having surgery, tell your doctor or dentist about all||
2139|097|P|the products you use (including prescription drugs,||
2139|098|P|nonprescription drugs, and herbal products).||
2139|099|P|   Older adults may be more sensitive to the side effects of this||
2139|100|P|drug, especially QT prolongation (see above).||
2139|101|P|   During pregnancy, this medication should be used only when||
2139|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
2139|103|P|   This medication passes into breast milk. Consult your doctor||
2139|104|P|before breastfeeding.||
2139|105|B|||
2139|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2139|107|I|medications work or increase your risk for serious side effects.||
2139|108|I|This document does not contain all possible drug interactions.||
2139|109|I|Keep a list of all the products you use (including||
2139|110|I|prescription/nonprescription drugs and herbal products) and share||
2139|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
2139|112|I|the dosage of any medicines without your doctor's approval.||
2139|113|I|   This medication may decrease the effectiveness of hormonal||
2139|114|I|birth control such as pills, patch, or ring. This could cause||
2139|115|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2139|116|I|use reliable backup birth control methods while using pitolisant||
2139|117|I|and for at least 21 days after stopping treatment with||
2139|118|I|pitolisant. Also tell your doctor if you have any new spotting or||
2139|119|I|breakthrough bleeding, because these may be signs that your birth||
2139|120|I|control is not working well.||
2139|121|B|||
2139|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2139|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2139|124|O|poison control center right away. US residents can call||
2139|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2139|126|B|||
2139|127|N|NOTES:  Do not share this medication with others.||
2139|128|N|   Lab and/or medical tests may be done while you are taking this||
2139|129|N|medication. Keep all medical and lab appointments. Consult your||
2139|130|N|doctor for more details.||
2139|131|B|||
2139|132|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2139|133|D|next dose at the regular time on the following day in the morning||
2139|134|D|when you wake up. Do not double the dose to catch up.||
2139|135|B|||
2139|136|R|STORAGE:  Store at room temperature away from light and moisture.||
2139|137|R|Do not store in the bathroom. Keep all medications away from||
2139|138|R|children and pets.||
2139|139|R|   Do not flush medications down the toilet or pour them into a||
2139|140|R|drain unless instructed to do so. Properly discard this product||
2139|141|R|when it is expired or no longer needed. Consult your pharmacist||
2139|142|R|or local waste disposal company.||
2139|143|B|||
2139|144|A|Information last revised September 2024.||
2139|145|A|Copyright(c) 2025 First Databank, Inc.||
2139|146|B|||
2140|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2140|002|Z|does NOT have all possible information about this product. This||
2140|003|Z|information does not assure that this product is safe, effective,||
2140|004|Z|or appropriate for you. This information is not individual||
2140|005|Z|medical advice and does not substitute for the advice of your||
2140|006|Z|health care professional. Always ask your health care||
2140|007|Z|professional for complete information about this product and your||
2140|008|Z|specific health needs.||
2140|009|B|||
2140|010|T|PLERIXAFOR - INJECTION||
2140|011|F|(pler-IX-a-for)||
2140|012|B|||
2140|013|C|COMMON BRAND NAME(S): Mozobil||
2140|014|B|||
2140|015|U|USES:  Plerixafor is used by patients with certain types of||
2140|016|U|cancer (non-Hodgkin's lymphoma-NHL, multiple myeloma-MM) to||
2140|017|U|prepare them for stem cell transplant. Stem cells, which are||
2140|018|U|found mainly in the bone marrow, turn into red blood cells, white||
2140|019|U|blood cells, and platelets. Plerixafor is used to help stem cells||
2140|020|U|move from the bone marrow to the bloodstream so that the cells||
2140|021|U|can be collected and stored. The stem cells are then infused back||
2140|022|U|into the patient after chemotherapy or radiation.||
2140|023|B|||
2140|024|H|HOW TO USE:  Inject this medication under the skin as directed by||
2140|025|H|your doctor, usually about 11 hours before the blood filtering||
2140|026|H|procedure. The dosage is based on your medical condition and||
2140|027|H|weight. Your doctor will also direct you to use another||
2140|028|H|medication (G-CSF) to prepare for the procedure. Carefully follow||
2140|029|H|your doctor's instructions on how to use both medications||
2140|030|H|correctly.||
2140|031|H|   Before using, check this product for particles or||
2140|032|H|discoloration. If either is present, do not use the liquid.||
2140|033|H|Before injecting each dose, clean the skin you are going to||
2140|034|H|inject into (the injection site) with rubbing alcohol. Change the||
2140|035|H|injection site each time to lessen injury under the skin. To||
2140|036|H|lessen bruising, do not rub the injection site after a shot.||
2140|037|H|Learn how to store and discard medical supplies safely.||
2140|038|B|||
2140|039|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, gas, dizziness, or||
2140|040|S|pain/redness/swelling at injection site may occur. If any of||
2140|041|S|these effects last or get worse, tell your doctor or pharmacist||
2140|042|S|promptly.||
2140|043|S|   Remember that this medication has been prescribed because your||
2140|044|S|doctor has judged that the benefit to you is greater than the||
2140|045|S|risk of side effects. Many people using this medication do not||
2140|046|S|have serious side effects.||
2140|047|S|   Tell your doctor right away if you have any serious side||
2140|048|S|effects, including: left upper abdominal pain, left shoulder||
2140|049|S|pain, fainting, easy bleeding/bruising.||
2140|050|S|   A very serious allergic reaction to this drug is rare.||
2140|051|S|However, get medical help right away if you notice any symptoms||
2140|052|S|of a serious allergic reaction, including: rash, itching/swelling||
2140|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2140|054|S|breathing.||
2140|055|S|   This is not a complete list of possible side effects. If you||
2140|056|S|notice other effects not listed above, contact your doctor or||
2140|057|S|pharmacist.||
2140|058|S|   In the US -||
2140|059|S|   Call your doctor for medical advice about side effects. You||
2140|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2140|061|S|www.fda.gov/medwatch.||
2140|062|S|   In Canada - Call your doctor for medical advice about side||
2140|063|S|effects. You may report side effects to Health Canada at||
2140|064|S|1-866-234-2345.||
2140|065|B|||
2140|066|P|PRECAUTIONS:  Before using plerixafor, tell your doctor or||
2140|067|P|pharmacist if you are allergic to it; or if you have any other||
2140|068|P|allergies. This product may contain inactive ingredients, which||
2140|069|P|can cause allergic reactions or other problems. Talk to your||
2140|070|P|pharmacist for more details.||
2140|071|P|   Before using this medication, tell your doctor or pharmacist||
2140|072|P|your medical history, especially of: kidney disease, leukemia.||
2140|073|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2140|074|P|can make you more dizzy. Do not drive, use machinery, or do||
2140|075|P|anything that needs alertness until you can do it safely. Limit||
2140|076|P|alcoholic beverages. Talk to your doctor if you are using||
2140|077|P|marijuana (cannabis).||
2140|078|P|   Before having surgery, tell your doctor or dentist about all||
2140|079|P|the products you use (including prescription drugs,||
2140|080|P|nonprescription drugs, and herbal products).||
2140|081|P|   Tell your doctor if you are pregnant or plan to become||
2140|082|P|pregnant. You should not become pregnant while using plerixafor.||
2140|083|P|Plerixafor may harm an unborn baby. Your doctor should order a||
2140|084|P|pregnancy test before you start this medication. Men and women||
2140|085|P|using this medication should ask about reliable forms of birth||
2140|086|P|control during treatment and for 1 week after the last dose. If||
2140|087|P|you or your partner becomes pregnant, talk to your doctor right||
2140|088|P|away about the risks and benefits of this medication.||
2140|089|P|   It is unknown if this medication passes into breast milk.||
2140|090|P|Because of the possible risk to the infant, breastfeeding is not||
2140|091|P|recommended while using this medication and for 1 week after the||
2140|092|P|last dose. Consult your doctor before breastfeeding.||
2140|093|B|||
2140|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2140|095|I|medications work or increase your risk for serious side effects.||
2140|096|I|This document does not contain all possible drug interactions.||
2140|097|I|Keep a list of all the products you use (including||
2140|098|I|prescription/nonprescription drugs and herbal products) and share||
2140|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2140|100|I|the dosage of any medicines without your doctor's approval.||
2140|101|B|||
2140|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2140|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2140|104|O|poison control center right away. US residents can call||
2140|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2140|106|O|Symptoms of overdose may include: fainting, severe dizziness.||
2140|107|B|||
2140|108|N|NOTES:  Do not share this medication with others.||
2140|109|N|   Lab and/or medical tests (such as complete blood count) should||
2140|110|N|be done while you are using it. Keep all medical and lab||
2140|111|N|appointments. Consult your doctor for more details.||
2140|112|B|||
2140|113|D|MISSED DOSE:  It is important to get each dose of this medication||
2140|114|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2140|115|D|right away for a new dosing schedule.||
2140|116|B|||
2140|117|R|STORAGE:  Store at room temperature. Keep all medications away||
2140|118|R|from children and pets.||
2140|119|R|   Do not flush medications down the toilet or pour them into a||
2140|120|R|drain unless instructed to do so. Properly discard this product||
2140|121|R|when it is expired or no longer needed. Consult your pharmacist||
2140|122|R|or local waste disposal company.||
2140|123|B|||
2140|124|A|Information last revised October 2024.||
2140|125|A|Copyright(c) 2025 First Databank, Inc.||
2140|126|B|||
2141|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2141|002|Z|does NOT have all possible information about this product. This||
2141|003|Z|information does not assure that this product is safe, effective,||
2141|004|Z|or appropriate for you. This information is not individual||
2141|005|Z|medical advice and does not substitute for the advice of your||
2141|006|Z|health care professional. Always ask your health care||
2141|007|Z|professional for complete information about this product and your||
2141|008|Z|specific health needs.||
2141|009|B|||
2141|010|T|AGALSIDASE BETA - INJECTION||
2141|011|F|(a-GAL-si-dase BAY-ta)||
2141|012|B|||
2141|013|C|COMMON BRAND NAME(S): Fabrazyme||
2141|014|B|||
2141|015|W|WARNING:  Agalsidase beta may cause serious (sometimes fatal)||
2141|016|W|allergic reactions. Get medical help right away if you have any||
2141|017|W|symptoms of a serious allergic reaction such as rash,||
2141|018|W|itching/swelling (especially of the face/tongue/throat), severe||
2141|019|W|dizziness, or trouble breathing.||
2141|020|B|||
2141|021|U|USES:  This medication is used to treat a certain inherited||
2141|022|U|disorder (Fabry disease) that causes buildup of a certain fat||
2141|023|U|substance (GL-3) in some parts of your body. Worsening of this||
2141|024|U|disorder can lead to kidney disease, heart attack, or stroke.||
2141|025|U|Agalsidase beta works by replacing an enzyme that your body||
2141|026|U|lacks, which helps break down the fat substance (GL-3) in your||
2141|027|U|body. This can help prevent symptoms such as pain (especially in||
2141|028|U|the hands and feet), dark red spots on the skin, a decreased||
2141|029|U|ability to sweat, cloudiness of the front part of the eye,||
2141|030|U|stomach/intestinal problems, ringing in the ears (tinnitus), and||
2141|031|U|hearing loss.||
2141|032|B|||
2141|033|H|HOW TO USE:  This medication is given by slow injection into a||
2141|034|H|vein as directed by your doctor, usually every 2 weeks. The||
2141|035|H|injection is given by a health care professional. The dosage is||
2141|036|H|based on your medical condition, weight, and response to||
2141|037|H|treatment.||
2141|038|H|   Infusion reactions may happen during the infusion of this||
2141|039|H|drug. Your doctor may prescribe other medications (such as||
2141|040|H|acetaminophen, antihistamine, corticosteroid) before each||
2141|041|H|treatment to help prevent these side effects. Tell your doctor||
2141|042|H|right away if you have any symptoms of infusion reactions such as||
2141|043|H|chills, flushing, itching, nausea, vomiting, dizziness,||
2141|044|H|numbness/tingling, shortness of breath, headache, or||
2141|045|H|chest/abdominal pain. Your doctor may give you other medications||
2141|046|H|to help with these side effects or may slow down or stop your||
2141|047|H|treatment for some time.||
2141|048|H|   Use this medication regularly to get the most benefit from it.||
2141|049|H|To help you remember, mark your calendar with a reminder.||
2141|050|H|   Tell your doctor if your condition does not get better or if||
2141|051|H|it gets worse.||
2141|052|B|||
2141|053|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2141|054|S|   Pain at the injection site, fever, tiredness, muscle pain,||
2141|055|S|dizziness, or cold symptoms (such as runny/stuffy nose, cough)||
2141|056|S|may also occur. If any of these effects last or get worse, tell||
2141|057|S|your doctor or pharmacist promptly.||
2141|058|S|   Remember that this medication has been prescribed because your||
2141|059|S|doctor has judged that the benefit to you is greater than the||
2141|060|S|risk of side effects. Many people using this medication do not||
2141|061|S|have serious side effects.||
2141|062|S|   Tell your doctor right away if you have any serious side||
2141|063|S|effects, including: swelling feet/legs/hands.||
2141|064|S|   This is not a complete list of possible side effects. If you||
2141|065|S|notice other effects not listed above, contact your doctor or||
2141|066|S|pharmacist.||
2141|067|S|   In the US -||
2141|068|S|   Call your doctor for medical advice about side effects. You||
2141|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2141|070|S|www.fda.gov/medwatch.||
2141|071|S|   In Canada - Call your doctor for medical advice about side||
2141|072|S|effects. You may report side effects to Health Canada at||
2141|073|S|1-866-234-2345.||
2141|074|B|||
2141|075|P|PRECAUTIONS:  Before using agalsidase beta, tell your doctor or||
2141|076|P|pharmacist if you are allergic to it; or if you have any other||
2141|077|P|allergies. This product may contain inactive ingredients, which||
2141|078|P|can cause allergic reactions or other problems. Talk to your||
2141|079|P|pharmacist for more details.||
2141|080|P|   Before using this medication, tell your doctor or pharmacist||
2141|081|P|your medical history, especially of: heart problems.||
2141|082|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2141|083|P|can make you more dizzy. Do not drive, use machinery, or do||
2141|084|P|anything that needs alertness until you can do it safely. Limit||
2141|085|P|alcoholic beverages. Talk to your doctor if you are using||
2141|086|P|marijuana (cannabis).||
2141|087|P|   Before having surgery, tell your doctor or dentist about all||
2141|088|P|the products you use (including prescription drugs,||
2141|089|P|nonprescription drugs, and herbal products).||
2141|090|P|   Tell your doctor if you are pregnant before using this||
2141|091|P|medication.||
2141|092|P|   It is unknown if this medication passes into breast milk.||
2141|093|P|Consult your doctor before breastfeeding.||
2141|094|B|||
2141|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2141|096|I|medications work or increase your risk for serious side effects.||
2141|097|I|This document does not contain all possible drug interactions.||
2141|098|I|Keep a list of all the products you use (including||
2141|099|I|prescription/nonprescription drugs and herbal products) and share||
2141|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
2141|101|I|the dosage of any medicines without your doctor's approval.||
2141|102|B|||
2141|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2141|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2141|105|O|poison control center right away. US residents can call||
2141|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2141|107|B|||
2141|108|N|NOTES:  Lab and/or medical tests may be done while you are using||
2141|109|N|this medication. Keep all medical and lab appointments.||
2141|110|B|||
2141|111|D|MISSED DOSE:  It is important to get each dose of this medication||
2141|112|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2141|113|D|right away for a new dosing schedule.||
2141|114|B|||
2141|115|R|STORAGE:  Not applicable. This medication is given in a hospital||
2141|116|R|or clinic or doctor's office and will not be stored at home.||
2141|117|B|||
2141|118|A|Information last revised October 2024.||
2141|119|A|Copyright(c) 2025 First Databank, Inc.||
2141|120|B|||
2142|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2142|002|Z|does NOT have all possible information about this product. This||
2142|003|Z|information does not assure that this product is safe, effective,||
2142|004|Z|or appropriate for you. This information is not individual||
2142|005|Z|medical advice and does not substitute for the advice of your||
2142|006|Z|health care professional. Always ask your health care||
2142|007|Z|professional for complete information about this product and your||
2142|008|Z|specific health needs.||
2142|009|B|||
2142|010|T|DINOPROSTONE GEL - VAGINAL||
2142|011|F|(DYE-noe-PROS-tone)||
2142|012|B|||
2142|013|C|COMMON BRAND NAME(S): Prepidil||
2142|014|B|||
2142|015|U|USES:  This medication is used to help prepare your cervix (the||
2142|016|U|lower opening of the womb) for labor and delivery. It is used by||
2142|017|U|women who are having a normal pregnancy and who are at or near||
2142|018|U|their delivery due date. Dinoprostone is a natural substance that||
2142|019|U|your body makes in preparation for labor. It relaxes and softens||
2142|020|U|your cervix (cervical ripening) to allow the baby to pass through||
2142|021|U|the birth canal during delivery.||
2142|022|B|||
2142|023|H|HOW TO USE:  This drug is inserted high in your vagina next to||
2142|024|H|the cervix by a health care professional. You will be lying on||
2142|025|H|your back with your knees bent outward while the medication is||
2142|026|H|placed, and you will usually need to continue lying down for at||
2142|027|H|least 15 to 30 minutes to prevent the gel from leaking out. The||
2142|028|H|health care professional will tell you when you can get up and||
2142|029|H|walk around.||
2142|030|H|   This medication should only be used in a hospital setting with||
2142|031|H|trained medical care available. You will be monitored for changes||
2142|032|H|in your cervix, for signs of active labor (such as water||
2142|033|H|breaking, strong sustained contractions), and for your baby's||
2142|034|H|condition. If you do not have signs of active labor after 6||
2142|035|H|hours, your doctor may give you another dose. The dosage is based||
2142|036|H|on your medical condition and response to treatment.||
2142|037|B|||
2142|038|S|SIDE EFFECTS:  Side effects such as fever, nausea, vomiting,||
2142|039|S|diarrhea, or abdominal pain are uncommon and usually mild. If any||
2142|040|S|of these effects last or get worse, tell your doctor or midwife||
2142|041|S|right away.||
2142|042|S|   Remember that this medication has been prescribed because your||
2142|043|S|doctor has judged that the benefit to you is greater than the||
2142|044|S|risk of side effects. Many people using this medication do not||
2142|045|S|have serious side effects.||
2142|046|S|   Tell your doctor right away if you have any serious side||
2142|047|S|effects, including: strong contractions that are very close||
2142|048|S|together (uterine overstimulation).||
2142|049|S|   Get medical help right away if you have any very serious side||
2142|050|S|effects, including: easy bruising/bleeding, shortness of breath,||
2142|051|S|chest pain, confusion.||
2142|052|S|   This drug has rarely caused injury to the womb (uterine||
2142|053|S|rupture), which may require emergency surgery. Symptoms include||
2142|054|S|severe pain in your womb and an abnormal heart rate in your baby.||
2142|055|S|Careful monitoring by your doctor or midwife may decrease your||
2142|056|S|risk.||
2142|057|S|   A very serious allergic reaction to this drug is rare.||
2142|058|S|However, get medical help right away if you notice any symptoms||
2142|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2142|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2142|061|S|breathing.||
2142|062|S|   This is not a complete list of possible side effects. If you||
2142|063|S|notice other effects not listed above, contact your doctor or||
2142|064|S|pharmacist.||
2142|065|S|   In the US -||
2142|066|S|   Call your doctor for medical advice about side effects. You||
2142|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2142|068|S|www.fda.gov/medwatch.||
2142|069|S|   In Canada - Call your doctor for medical advice about side||
2142|070|S|effects. You may report side effects to Health Canada at||
2142|071|S|1-866-234-2345.||
2142|072|B|||
2142|073|P|PRECAUTIONS:  Before using dinoprostone, tell your doctor,||
2142|074|P|midwife, or pharmacist if you are allergic to it; or if you have||
2142|075|P|any other allergies. This product may contain inactive||
2142|076|P|ingredients, which can cause allergic reactions or other||
2142|077|P|problems. Talk to your pharmacist for more details.||
2142|078|P|   Before using this drug, tell your doctor your medical history,||
2142|079|P|especially of: asthma, full-term births including previous||
2142|080|P|cesarean section (c-section) births, glaucoma, infections in the||
2142|081|P|vaginal area (such as genital herpes), vaginal bleeding during||
2142|082|P|pregnancy, surgery on the cervix/womb, womb scarring.||
2142|083|P|   Before having surgery, tell your doctor or dentist about all||
2142|084|P|the products you use (including prescription drugs,||
2142|085|P|nonprescription drugs, and herbal products).||
2142|086|P|   This drug should not be used if you are carrying more than one||
2142|087|P|baby, if your labor has already started, or if your water has||
2142|088|P|broken.||
2142|089|P|   During pregnancy, this medication should be used only when||
2142|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
2142|091|P|   It is unknown if this drug passes into breast milk. Consult||
2142|092|P|your doctor before breastfeeding.||
2142|093|B|||
2142|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2142|095|I|medications work or increase your risk for serious side effects.||
2142|096|I|This document does not contain all possible drug interactions.||
2142|097|I|Keep a list of all the products you use (including||
2142|098|I|prescription/nonprescription drugs and herbal products) and share||
2142|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2142|100|I|the dosage of any medicines without your doctor's approval.||
2142|101|I|   Some products that may interact with this drug are: other||
2142|102|I|prostaglandins (such as misoprostol), oxytocin.||
2142|103|B|||
2142|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2142|105|O|has overdosed and has serious symptoms such as passing out or||
2142|106|O|trouble breathing, call 911. Otherwise, call a poison control||
2142|107|O|center right away. US residents can call 1-800-222-1222. Canada||
2142|108|O|residents can call 1-844-764-7669.||
2142|109|B|||
2142|110|N|NOTES:  Use under direct medical supervision.||
2142|111|B|||
2142|112|D|MISSED DOSE:  Not applicable.||
2142|113|B|||
2142|114|R|STORAGE:  Not applicable. This medication is given in a hospital||
2142|115|R|or clinic and will not be stored at home.||
2142|116|B|||
2142|117|A|Information last revised May 2024.||
2142|118|A|Copyright(c) 2025 First Databank, Inc.||
2142|119|B|||
2143|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2143|002|Z|does NOT have all possible information about this product. This||
2143|003|Z|information does not assure that this product is safe, effective,||
2143|004|Z|or appropriate for you. This information is not individual||
2143|005|Z|medical advice and does not substitute for the advice of your||
2143|006|Z|health care professional. Always ask your health care||
2143|007|Z|professional for complete information about this product and your||
2143|008|Z|specific health needs.||
2143|009|B|||
2143|010|T|ESOMEPRAZOLE DELAYED-RELEASE TABLET - ORAL||
2143|011|F|(ES-oh-MEP-ra-zole)||
2143|012|B|||
2143|013|C|COMMON BRAND NAME(S): Nexium 24HR||
2143|014|B|||
2143|015|U|USES:  Esomeprazole is used to treat certain stomach and||
2143|016|U|esophagus problems (such as acid reflux, ulcers). It works by||
2143|017|U|decreasing the amount of acid your stomach makes. It relieves||
2143|018|U|symptoms such as heartburn, difficulty swallowing, and cough.||
2143|019|U|This medication helps heal acid damage to the stomach and||
2143|020|U|esophagus, helps prevent ulcers, and may help prevent cancer of||
2143|021|U|the esophagus. Esomeprazole belongs to a class of drugs known as||
2143|022|U|proton pump inhibitors (PPIs).||
2143|023|U|   If you are self-treating with this medication,||
2143|024|U|over-the-counter esomeprazole products are used to treat frequent||
2143|025|U|heartburn (occurring 2 or more days a week). Since it may take 1||
2143|026|U|to 4 days to have full effect, these products do not relieve||
2143|027|U|heartburn right away.||
2143|028|U|   For over-the-counter products, carefully read the package||
2143|029|U|instructions to make sure the product is right for you. Check the||
2143|030|U|ingredients on the label even if you have used the product||
2143|031|U|before. The manufacturer may have changed the ingredients. Also,||
2143|032|U|products with similar brand names may contain different||
2143|033|U|ingredients meant for different purposes. Taking the wrong||
2143|034|U|product could harm you.||
2143|035|B|||
2143|036|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2143|037|H|from your pharmacist before you start taking esomeprazole and||
2143|038|H|each time you get a refill. If you have any questions, ask your||
2143|039|H|doctor or pharmacist.||
2143|040|H|   If you are taking the over-the-counter product to self-treat,||
2143|041|H|read and follow all directions on the product package before||
2143|042|H|taking this medication. If you have any questions, consult your||
2143|043|H|pharmacist. If your doctor has prescribed this medication, take||
2143|044|H|it as directed, usually once daily. Do not crush or chew this||
2143|045|H|medication. Swallow the tablets whole.||
2143|046|H|   The dosage and length of treatment are based on your medical||
2143|047|H|condition and response to treatment. Do not increase your dose or||
2143|048|H|take this drug more often than directed. If you have any||
2143|049|H|questions, ask your doctor or pharmacist.||
2143|050|H|   If needed, antacids may be taken along with this medication.||
2143|051|H|If you are also taking sucralfate, take esomeprazole at least 30||
2143|052|H|minutes before sucralfate.||
2143|053|H|   Use this medication regularly to get the most benefit from it.||
2143|054|H|To help you remember, take it at the same time each day. Continue||
2143|055|H|to take this medication for the prescribed length of treatment||
2143|056|H|even if you are feeling better. If you are self-treating with the||
2143|057|H|over-the-counter product, do not take it for more than 14 days||
2143|058|H|unless directed by your doctor.||
2143|059|H|   Tell your doctor if your condition lasts or gets worse. If you||
2143|060|H|are self-treating, tell your doctor if your heartburn lasts after||
2143|061|H|14 days or if you need to use this medication more than once||
2143|062|H|every 4 months. The risk of side effects goes up over time. Ask||
2143|063|H|your doctor how long you should take this medication. If you||
2143|064|H|think you may have a serious medical problem, get medical help||
2143|065|H|right away.||
2143|066|B|||
2143|067|S|SIDE EFFECTS:  See also Precautions section.||
2143|068|S|   Headache or abdominal pain may occur. If any of these effects||
2143|069|S|last or get worse, tell your doctor or pharmacist promptly.||
2143|070|S|   If your doctor has directed you to use this medication,||
2143|071|S|remember that your doctor has judged that the benefit to you is||
2143|072|S|greater than the risk of side effects. Many people using this||
2143|073|S|medication do not have serious side effects.||
2143|074|S|   Tell your doctor right away if you have any serious side||
2143|075|S|effects, including: symptoms of a low magnesium blood level (such||
2143|076|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
2143|077|S|(such as rash on nose and cheeks, new or worsening joint pain),||
2143|078|S|signs of kidney problems (such as change in the amount of urine,||
2143|079|S|pink/bloody urine).||
2143|080|S|   This medication may rarely cause a severe intestinal condition||
2143|081|S|due to a bacteria called C. difficile. This condition may occur||
2143|082|S|during treatment or weeks to months after treatment has stopped.||
2143|083|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2143|084|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2143|085|S|stool.||
2143|086|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2143|087|S|products because they may make symptoms worse.||
2143|088|S|   Rarely, proton pump inhibitors (such as esomeprazole) have||
2143|089|S|caused vitamin B-12 deficiency. The risk is increased if they are||
2143|090|S|taken every day for a long time (3 years or longer). Tell your||
2143|091|S|doctor right away if you develop symptoms of vitamin B-12||
2143|092|S|deficiency (such as unusual weakness, sore tongue, or||
2143|093|S|numbness/tingling of the hands/feet).||
2143|094|S|   A very serious allergic reaction to this drug is rare.||
2143|095|S|However, get medical help right away if you notice any symptoms||
2143|096|S|of a serious allergic reaction, including: fever, swollen lymph||
2143|097|S|nodes, rash, itching/swelling (especially of the||
2143|098|S|face/tongue/throat), severe dizziness, trouble breathing.||
2143|099|S|   This is not a complete list of possible side effects. If you||
2143|100|S|notice other effects not listed above, contact your doctor or||
2143|101|S|pharmacist.||
2143|102|S|   In the US -||
2143|103|S|   Call your doctor for medical advice about side effects. You||
2143|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2143|105|S|www.fda.gov/medwatch.||
2143|106|S|   In Canada - Call your doctor for medical advice about side||
2143|107|S|effects. You may report side effects to Health Canada at||
2143|108|S|1-866-234-2345.||
2143|109|B|||
2143|110|P|PRECAUTIONS:  Before taking esomeprazole, tell your doctor or||
2143|111|P|pharmacist if you are allergic to it; or to other PPIs (such as||
2143|112|P|lansoprazole, omeprazole); or if you have any other allergies.||
2143|113|P|This product may contain inactive ingredients, which can cause||
2143|114|P|allergic reactions or other problems. Talk to your pharmacist for||
2143|115|P|more details.||
2143|116|P|   Before using this medication, tell your doctor or pharmacist||
2143|117|P|your medical history, especially of: liver disease, lupus.||
2143|118|P|   Some symptoms may actually be signs of a more serious||
2143|119|P|condition. Get medical help right away if you have: heartburn||
2143|120|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
2143|121|P|pain (especially with shortness of breath, unusual sweating),||
2143|122|P|unexplained weight loss.||
2143|123|P|   In addition, before you self-treat with this medication, get||
2143|124|P|medical help right away if you have any of these signs of a||
2143|125|P|serious condition: trouble/pain swallowing food, bloody vomit,||
2143|126|P|vomit that looks like coffee grounds, bloody/black stools,||
2143|127|P|heartburn for over 3 months, frequent chest pain, frequent||
2143|128|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
2143|129|P|pain.||
2143|130|P|   Before having surgery, tell your doctor or dentist about all||
2143|131|P|the products you use (including prescription drugs,||
2143|132|P|nonprescription drugs, and herbal products).||
2143|133|P|   Proton pump inhibitors (such as esomeprazole) may increase||
2143|134|P|your risk for bone fractures, especially with longer use, higher||
2143|135|P|doses, and in older adults. Talk with your doctor or pharmacist||
2143|136|P|about ways to prevent bone loss/fracture, such as by taking||
2143|137|P|calcium (such as calcium citrate) and vitamin D supplements.||
2143|138|P|   Older adults may be more sensitive to the side effects of this||
2143|139|P|drug, especially bone loss and fractures (see above), and C.||
2143|140|P|difficile infection (see Side Effects section).||
2143|141|P|   Children may be more sensitive to the side effects of this||
2143|142|P|drug, especially fever, cough, and infections of the||
2143|143|P|nose/throat/airways.||
2143|144|P|   During pregnancy, this medication should be used only when||
2143|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
2143|146|P|   It is unknown if this medication passes into breast milk.||
2143|147|P|However, similar drugs pass into breast milk. The effects on a||
2143|148|P|nursing infant are unknown. Consult your doctor before||
2143|149|P|breastfeeding.||
2143|150|B|||
2143|151|I|DRUG INTERACTIONS:  See also How to Use section.||
2143|152|I|   Drug interactions may change how your medications work or||
2143|153|I|increase your risk for serious side effects. This document does||
2143|154|I|not contain all possible drug interactions. Keep a list of all||
2143|155|I|the products you use (including prescription/nonprescription||
2143|156|I|drugs and herbal products) and share it with your doctor and||
2143|157|I|pharmacist. Do not start, stop, or change the dosage of any||
2143|158|I|medicines without your doctor's approval.||
2143|159|I|   Some products that may interact with this drug include:||
2143|160|I|clopidogrel, methotrexate (especially high-dose treatment),||
2143|161|I|rifampin, St John's wort.||
2143|162|I|   Some products need stomach acid so that the body can absorb||
2143|163|I|them properly. Esomeprazole decreases stomach acid, so it may||
2143|164|I|change how well these products work. Some affected products||
2143|165|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
2143|166|I|pazopanib, rilpivirine, sparsentan, certain azole antifungals||
2143|167|I|(itraconazole, ketoconazole, posaconazole), among others.||
2143|168|I|   Esomeprazole is very similar to omeprazole. Do not use any||
2143|169|I|medications containing omeprazole while using esomeprazole.||
2143|170|I|   This medication may interfere with certain lab tests, possibly||
2143|171|I|causing false test results. Make sure lab personnel and all your||
2143|172|I|doctors know you use this drug.||
2143|173|B|||
2143|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2143|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2143|176|O|poison control center right away. US residents can call||
2143|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2143|178|O|Symptoms of overdose may include: confusion, extreme sweating,||
2143|179|O|blurred vision, or unusually fast heartbeat.||
2143|180|B|||
2143|181|N|NOTES:  If your doctor has prescribed this medication for you, do||
2143|182|N|not share it with others.||
2143|183|N|   If your doctor instructs you to use this medication regularly||
2143|184|N|for a long time, lab and/or medical tests (such as a magnesium||
2143|185|N|blood test, vitamin B-12 levels) may be done while you are taking||
2143|186|N|this medication. Keep all medical and lab appointments. Consult||
2143|187|N|your doctor for more details.||
2143|188|B|||
2143|189|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2143|190|D|remember. If it is near the time of the next dose, skip the||
2143|191|D|missed dose. Take your next dose at the regular time. Do not||
2143|192|D|double the dose to catch up.||
2143|193|B|||
2143|194|R|STORAGE:  Store at room temperature away from moisture. Do not||
2143|195|R|store in the bathroom. Keep all medications away from children||
2143|196|R|and pets.||
2143|197|R|   Do not flush medications down the toilet or pour them into a||
2143|198|R|drain unless instructed to do so. Properly discard this product||
2143|199|R|when it is expired or no longer needed. Consult your pharmacist||
2143|200|R|or local waste disposal company.||
2143|201|B|||
2143|202|A|Information last revised April 2025.||
2143|203|A|Copyright(c) 2025 First Databank, Inc.||
2143|204|B|||
2144|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2144|002|Z|does NOT have all possible information about this product. This||
2144|003|Z|information does not assure that this product is safe, effective,||
2144|004|Z|or appropriate for you. This information is not individual||
2144|005|Z|medical advice and does not substitute for the advice of your||
2144|006|Z|health care professional. Always ask your health care||
2144|007|Z|professional for complete information about this product and your||
2144|008|Z|specific health needs.||
2144|009|B|||
2144|010|T|COLCHICINE SOLUTION - ORAL||
2144|011|F|(KOL-chi-seen)||
2144|012|B|||
2144|013|C|COMMON BRAND NAME(S): Gloperba||
2144|014|B|||
2144|015|U|USES:  This medication is used to prevent gout attacks (flares).||
2144|016|U|Gout symptoms usually develop suddenly and involve only one or a||
2144|017|U|few joints. The big toe, knee, or ankle joints are most often||
2144|018|U|affected. Gout is caused by too much uric acid in the blood. When||
2144|019|U|uric acid levels in the blood are too high, the uric acid may||
2144|020|U|form hard crystals in your joints. Colchicine works by decreasing||
2144|021|U|swelling and lessening the buildup of uric acid crystals that||
2144|022|U|cause pain in the affected joint(s).||
2144|023|U|   Colchicine is not a pain medication. Do not use it to relieve||
2144|024|U|other causes of pain.||
2144|025|B|||
2144|026|H|HOW TO USE:  Read the Medication Guide provided by your||
2144|027|H|pharmacist before you start taking colchicine and each time you||
2144|028|H|get a refill. If you have any questions, ask your doctor or||
2144|029|H|pharmacist.||
2144|030|H|   Take this medication by mouth with or without food as directed||
2144|031|H|by your doctor, usually once or twice a day. Carefully measure||
2144|032|H|the dose using a special measuring device/spoon. Do not use a||
2144|033|H|household spoon because you may not get the correct dose.||
2144|034|H|   The dosage is based on your medical condition, other||
2144|035|H|medications you may be taking, and response to treatment. Be sure||
2144|036|H|to tell your doctor and pharmacist about all the products you use||
2144|037|H|(including prescription drugs, nonprescription drugs, and herbal||
2144|038|H|products).||
2144|039|H|   Do not increase your dose or use this drug more often or for||
2144|040|H|longer than prescribed. Your condition will not improve any||
2144|041|H|faster, and your risk of side effects will increase. Serious side||
2144|042|H|effects may occur even at usual prescribed doses.||
2144|043|H|   Take this medication regularly to get the most benefit from||
2144|044|H|it. To help you remember, take it at the same time(s) each day.||
2144|045|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2144|046|H|using this medication unless your doctor or pharmacist says you||
2144|047|H|may do so safely. Grapefruit can increase the chance of side||
2144|048|H|effects with this medicine. Ask your doctor or pharmacist for||
2144|049|H|more details.||
2144|050|B|||
2144|051|S|SIDE EFFECTS:  Diarrhea, nausea, cramping, abdominal pain, and||
2144|052|S|vomiting may occur. If any of these effects last or get worse,||
2144|053|S|tell your doctor or pharmacist promptly.||
2144|054|S|   Remember that this medication has been prescribed because your||
2144|055|S|doctor has judged that the benefit to you is greater than the||
2144|056|S|risk of side effects. Many people using this medication do not||
2144|057|S|have serious side effects.||
2144|058|S|   Stop taking this medication and get medical help right away if||
2144|059|S|any of these very serious side effects occur: unusual||
2144|060|S|bleeding/bruising, muscle weakness or pain, numbness/tingling in||
2144|061|S|your fingers or toes, pale or gray color of the lips/tongue/palms||
2144|062|S|of hands, signs of infection (such as sore throat that doesn't go||
2144|063|S|away, fever, chills), unusual weakness/tiredness, fast heartbeat,||
2144|064|S|signs of kidney problems (such as change in the amount of urine).||
2144|065|S|   A very serious allergic reaction to this drug is rare.||
2144|066|S|However, get medical help right away if you notice any symptoms||
2144|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2144|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2144|069|S|breathing.||
2144|070|S|   This is not a complete list of possible side effects. If you||
2144|071|S|notice other effects not listed above, contact your doctor or||
2144|072|S|pharmacist.||
2144|073|S|   In the US -||
2144|074|S|   Call your doctor for medical advice about side effects. You||
2144|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2144|076|S|www.fda.gov/medwatch.||
2144|077|S|   In Canada - Call your doctor for medical advice about side||
2144|078|S|effects. You may report side effects to Health Canada at||
2144|079|S|1-866-234-2345.||
2144|080|B|||
2144|081|P|PRECAUTIONS:  Before taking colchicine, tell your doctor or||
2144|082|P|pharmacist if you are allergic to it; or if you have any other||
2144|083|P|allergies. This product may contain inactive ingredients, which||
2144|084|P|can cause allergic reactions or other problems. Talk to your||
2144|085|P|pharmacist for more details.||
2144|086|P|   Before using this medication, tell your doctor or pharmacist||
2144|087|P|your medical history, especially of: kidney problems, liver||
2144|088|P|problems.||
2144|089|P|   Alcohol can make this drug work less well. Limit alcohol while||
2144|090|P|taking this drug.||
2144|091|P|   This medication may contain sugar or aspartame. Caution is||
2144|092|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
2144|093|P|condition that requires you to limit/avoid these substances in||
2144|094|P|your diet. Ask your doctor or pharmacist about using this product||
2144|095|P|safely.||
2144|096|P|   This medication can affect how well your body absorbs some||
2144|097|P|foods and nutrients (such as vitamin B12). Consult your doctor or||
2144|098|P|pharmacist for more details.||
2144|099|P|   Before having surgery, tell your doctor or dentist about all||
2144|100|P|the products you use (including prescription drugs,||
2144|101|P|nonprescription drugs, and herbal products).||
2144|102|P|   Older adults may be more sensitive to the side effects of this||
2144|103|P|drug, especially muscle weakness/pain and numbness/tingling in||
2144|104|P|their fingers or toes.||
2144|105|P|   Colchicine can decrease sperm production, an effect that may||
2144|106|P|lower male fertility. Consult your doctor for more details.||
2144|107|P|   During pregnancy, this medication should be used only when||
2144|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
2144|109|P|   This medication passes into breast milk. Consult your doctor||
2144|110|P|before breastfeeding.||
2144|111|B|||
2144|112|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
2144|113|I|   Drug interactions may change how your medications work or||
2144|114|I|increase your risk for serious side effects. This document does||
2144|115|I|not contain all possible drug interactions. Keep a list of all||
2144|116|I|the products you use (including prescription/nonprescription||
2144|117|I|drugs and herbal products) and share it with your doctor and||
2144|118|I|pharmacist. Do not start, stop, or change the dosage of any||
2144|119|I|medicines without your doctor's approval.||
2144|120|I|   Other medications can affect the removal of colchicine from||
2144|121|I|your body, which may affect how colchicine works or increase the||
2144|122|I|risk of serious side effects. Examples include atazanavir,||
2144|123|I|certain azole antifungals (such as itraconazole, ketoconazole),||
2144|124|I|diltiazem, macrolide antibiotics (such as clarithromycin,||
2144|125|I|erythromycin), ritonavir, telithromycin, verapamil, among others.||
2144|126|I|   Colchicine may rarely cause a certain kind of serious (even||
2144|127|I|fatal) muscle damage (rhabdomyolysis). This muscle damage||
2144|128|I|releases substances that can lead to serious kidney problems. The||
2144|129|I|risk may be increased if other drugs that may also cause||
2144|130|I|rhabdomyolysis are taken along with colchicine. Some affected||
2144|131|I|drugs include: digoxin, gemfibrozil, pravastatin, simvastatin,||
2144|132|I|among others.||
2144|133|I|   Do not take this medication with any other product that||
2144|134|I|contains colchicine.||
2144|135|I|   This medication may interfere with certain lab tests, possibly||
2144|136|I|causing false test results. Make sure lab personnel and all your||
2144|137|I|doctors know you use this drug.||
2144|138|B|||
2144|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2144|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2144|141|O|poison control center right away. US residents can call||
2144|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2144|143|O|Symptoms of overdose may include: severe||
2144|144|O|nausea/vomiting/diarrhea, abdominal pain, trouble breathing,||
2144|145|O|weakness.||
2144|146|B|||
2144|147|N|NOTES:  Do not share this medication with others.||
2144|148|N|   Being overweight, drinking too much alcohol, and eating||
2144|149|N|certain foods may worsen gout symptoms. Limit alcohol and ask||
2144|150|N|your doctor, pharmacist, or dietitian about avoiding foods high||
2144|151|N|in purines that may worsen gout (such as anchovies, bacon, beer,||
2144|152|N|sardines, organ meats including liver/kidneys).||
2144|153|N|   Lab and/or medical tests (such as complete blood count,||
2144|154|N|kidney/liver function) may be done while you are taking this||
2144|155|N|medication. Keep all medical and lab appointments.||
2144|156|B|||
2144|157|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2144|158|D|remember. If it is near the time of the next dose, skip the||
2144|159|D|missed dose. Take your next dose at the regular time. Do not||
2144|160|D|double the dose to catch up.||
2144|161|B|||
2144|162|R|STORAGE:  Store at room temperature. Keep all medications away||
2144|163|R|from children and pets.||
2144|164|R|   Do not flush medications down the toilet or pour them into a||
2144|165|R|drain unless instructed to do so. Properly discard this product||
2144|166|R|when it is expired or no longer needed. Consult your pharmacist||
2144|167|R|or local waste disposal company.||
2144|168|B|||
2144|169|A|Information last revised January 2025.||
2144|170|A|Copyright(c) 2025 First Databank, Inc.||
2144|171|B|||
2145|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2145|002|Z|does NOT have all possible information about this product. This||
2145|003|Z|information does not assure that this product is safe, effective,||
2145|004|Z|or appropriate for you. This information is not individual||
2145|005|Z|medical advice and does not substitute for the advice of your||
2145|006|Z|health care professional. Always ask your health care||
2145|007|Z|professional for complete information about this product and your||
2145|008|Z|specific health needs.||
2145|009|B|||
2145|010|T|DIROXIMEL FUMARATE DELAYED-RELEASE - ORAL||
2145|011|F|(dye-ROX-i-mel FUE-ma-rate)||
2145|012|B|||
2145|013|C|COMMON BRAND NAME(S): Vumerity||
2145|014|B|||
2145|015|U|USES:  Diroximel fumarate is used to treat multiple sclerosis||
2145|016|U|(MS). It is not a cure for MS. It helps decrease the number of||
2145|017|U|episodes of worsening MS.||
2145|018|B|||
2145|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2145|020|H|from your pharmacist before you start taking diroximel fumarate||
2145|021|H|and each time you get a refill. If you have any questions, ask||
2145|022|H|your doctor or pharmacist.||
2145|023|H|   Take this medication by mouth with or without food as directed||
2145|024|H|by your doctor, usually twice daily. Swallow the capsules whole.||
2145|025|H|Do not crush, chew, or sprinkle the capsule contents on food.||
2145|026|H|Doing so can release all of the drug at once, increasing the risk||
2145|027|H|of side effects.||
2145|028|H|   To reduce your risk of side effects, your doctor may direct||
2145|029|H|you to start this medication at a low dose for the first 7 days,||
2145|030|H|and then may increase your dose. Follow your doctor's||
2145|031|H|instructions carefully. If flushing occurs, taking this||
2145|032|H|medication with food, or taking a plain (non-enteric coated)||
2145|033|H|aspirin 30 minutes before your dose, may lessen this effect. If||
2145|034|H|you take it with food, do not take it with a high-fat,||
2145|035|H|high-calorie meal/snack (more than 700 calories and more than 30||
2145|036|H|grams fat). Also, do not drink alcohol with your dose of||
2145|037|H|medication.||
2145|038|H|   Take this medication regularly to get the most benefit from||
2145|039|H|it. To help you remember, take it at the same times each day.||
2145|040|H|   Tell your doctor if your condition gets worse.||
2145|041|B|||
2145|042|S|SIDE EFFECTS:  Flushing/warmth, redness, itching, and burning||
2145|043|S|feeling of the skin may occur. Stomach/abdominal pain, diarrhea,||
2145|044|S|nausea, and vomiting may also occur. These effects usually get||
2145|045|S|better or go away as your body adjusts to the medication. If any||
2145|046|S|of these effects last or get worse, tell your doctor or||
2145|047|S|pharmacist promptly.||
2145|048|S|   Remember that this medication has been prescribed because your||
2145|049|S|doctor has judged that the benefit to you is greater than the||
2145|050|S|risk of side effects. Many people using this medication do not||
2145|051|S|have serious side effects.||
2145|052|S|   This medication may lower your ability to fight infections.||
2145|053|S|This may make you more likely to get a serious (rarely fatal)||
2145|054|S|infection or make any infection you have worse. Tell your doctor||
2145|055|S|right away if you have any signs of infection (such as sore||
2145|056|S|throat that doesn't go away, fever, chills, blisters).||
2145|057|S|   Tell your doctor right away if you have any serious side||
2145|058|S|effects, including: symptoms of liver damage (such as||
2145|059|S|nausea/vomiting that doesn't stop, loss of appetite,||
2145|060|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2145|061|S|black/bloody stools, vomit that contains blood or looks like||
2145|062|S|coffee grounds, coughing up blood.||
2145|063|S|   This medication may increase your risk of getting a rare but||
2145|064|S|very serious (possibly fatal) brain infection (progressive||
2145|065|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2145|066|S|if you have any of these side effects: clumsiness, loss of||
2145|067|S|coordination/balance, weakness, sudden change in your thinking||
2145|068|S|(such as confusion, difficulty concentrating, memory loss),||
2145|069|S|difficulty talking/walking, seizure, vision changes.||
2145|070|S|   A very serious allergic reaction to this drug is rare.||
2145|071|S|However, get medical help right away if you notice any symptoms||
2145|072|S|of a serious allergic reaction, including: rash, itching/swelling||
2145|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2145|074|S|breathing.||
2145|075|S|   This is not a complete list of possible side effects. If you||
2145|076|S|notice other effects not listed above, contact your doctor or||
2145|077|S|pharmacist.||
2145|078|S|   In the US -||
2145|079|S|   Call your doctor for medical advice about side effects. You||
2145|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2145|081|S|www.fda.gov/medwatch.||
2145|082|S|   In Canada - Call your doctor for medical advice about side||
2145|083|S|effects. You may report side effects to Health Canada at||
2145|084|S|1-866-234-2345.||
2145|085|B|||
2145|086|P|PRECAUTIONS:  Before taking diroximel fumarate, tell your doctor||
2145|087|P|or pharmacist if you are allergic to it; or to dimethyl fumarate;||
2145|088|P|or to monomethyl fumarate; or if you have any other allergies.||
2145|089|P|This product may contain inactive ingredients which can cause||
2145|090|P|allergic reactions or other problems. Talk to your pharmacist for||
2145|091|P|more details.||
2145|092|P|   Before using this medication, tell your doctor or pharmacist||
2145|093|P|your medical history, especially of: low white blood cell counts,||
2145|094|P|infections (including any current infection), kidney problems,||
2145|095|P|liver problems.||
2145|096|P|   Diroximel fumarate can make you more likely to get infections||
2145|097|P|or may make current infections worse. Stay away from anyone who||
2145|098|P|has an infection that may easily spread (such as chickenpox,||
2145|099|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2145|100|P|exposed to an infection or for more details.||
2145|101|P|   Tell your health care professional that you are using||
2145|102|P|diroximel fumarate before having any immunizations/vaccinations.||
2145|103|P|Avoid contact with people who have recently received live||
2145|104|P|vaccines (such as flu vaccine inhaled through the nose).||
2145|105|P|   Before having surgery, tell your doctor or dentist about all||
2145|106|P|the products you use (including prescription drugs,||
2145|107|P|nonprescription drugs, and herbal products).||
2145|108|P|   During pregnancy, this medication should be used only when||
2145|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
2145|110|P|   It is unknown if this medication passes into breast milk.||
2145|111|P|Consult your doctor before breastfeeding.||
2145|112|B|||
2145|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2145|114|I|medications work or increase your risk for serious side effects.||
2145|115|I|This document does not contain all possible drug interactions.||
2145|116|I|Keep a list of all the products you use (including||
2145|117|I|prescription/nonprescription drugs and herbal products) and share||
2145|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
2145|119|I|the dosage of any medicines without your doctor's approval.||
2145|120|I|   Some products that may interact with this drug are: other||
2145|121|I|drugs that weaken the immune system/increase the risk of||
2145|122|I|infection (such as natalizumab, rituximab).||
2145|123|I|   Diroximel fumarate is very similar to dimethyl fumarate and||
2145|124|I|monomethyl fumarate. Do not use medications containing dimethyl||
2145|125|I|fumarate or monomethyl fumarate while using diroximel fumarate.||
2145|126|B|||
2145|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2145|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2145|129|O|poison control center right away. US residents can call||
2145|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2145|131|B|||
2145|132|N|NOTES:  Do not share this medication with others.||
2145|133|N|   Lab tests (such as complete blood counts, liver function)||
2145|134|N|should be done before you start taking this medication and while||
2145|135|N|you are taking it. Keep all medical and lab appointments.||
2145|136|B|||
2145|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2145|138|D|remember. If it is near the time of the next dose, skip the||
2145|139|D|missed dose. Take your next dose at the regular time. Do not||
2145|140|D|double the dose to catch up.||
2145|141|B|||
2145|142|R|STORAGE:  Store at room temperature away from light and moisture.||
2145|143|R|Do not store in the bathroom. Keep all medications away from||
2145|144|R|children and pets.||
2145|145|R|   Do not flush medications down the toilet or pour them into a||
2145|146|R|drain unless instructed to do so. Properly discard this product||
2145|147|R|when it is expired or no longer needed. Consult your pharmacist||
2145|148|R|or local waste disposal company.||
2145|149|B|||
2145|150|M|MEDICAL ALERT:  Your condition can cause complications in a||
2145|151|M|medical emergency. For information about enrolling in MedicAlert,||
2145|152|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2145|153|B|||
2145|154|A|Information last revised July 2025.||
2145|155|A|Copyright(c) 2025 First Databank, Inc.||
2145|156|B|||
2146|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2146|002|Z|does NOT have all possible information about this product. This||
2146|003|Z|information does not assure that this product is safe, effective,||
2146|004|Z|or appropriate for you. This information is not individual||
2146|005|Z|medical advice and does not substitute for the advice of your||
2146|006|Z|health care professional. Always ask your health care||
2146|007|Z|professional for complete information about this product and your||
2146|008|Z|specific health needs.||
2146|009|B|||
2146|010|T|GLYCEROL PHENYLBUTYRATE - ORAL||
2146|011|F|(GLIS-er-ol FEN-il-BUE-ti-rate)||
2146|012|B|||
2146|013|C|COMMON BRAND NAME(S): Ravicti||
2146|014|B|||
2146|015|U|USES:  This medication is used along with diet changes for||
2146|016|U|long-term treatment of a certain inherited disorder (urea cycle||
2146|017|U|disorder). It helps remove a certain chemical (ammonia) from the||
2146|018|U|body. Too much ammonia in the body can cause brain damage and||
2146|019|U|sometimes death.||
2146|020|U|   This medication should not be used to treat sudden, severely||
2146|021|U|high levels of ammonia in the body. Get medical help right away||
2146|022|U|if you have sudden symptoms of too much ammonia, such as trouble||
2146|023|U|thinking, vomiting, irritability, trouble speaking, trouble||
2146|024|U|walking, fainting.||
2146|025|B|||
2146|026|H|HOW TO USE:  Read the Medication Guide provided by your||
2146|027|H|pharmacist before you start taking glycerol phenylbutyrate and||
2146|028|H|each time you get a refill. Learn all preparation and usage||
2146|029|H|instructions. If you have any questions, ask your doctor or||
2146|030|H|pharmacist.||
2146|031|H|   Take this medication by mouth exactly as directed by your||
2146|032|H|doctor. The dosage is based on your body size, medical condition,||
2146|033|H|and response to treatment. The total daily dose should be divided||
2146|034|H|into equal amounts and taken with each meal or feeding (such as 3||
2146|035|H|to 6 times daily). Do not increase or decrease your dose without||
2146|036|H|your doctor's approval.||
2146|037|H|   Carefully measure the dose using an oral syringe. Do not use a||
2146|038|H|household spoon because you may not get the correct dose.||
2146|039|H|   If you are giving this medication through a tube into the||
2146|040|H|stomach (nasogastric or gastric tube), ask your health care||
2146|041|H|professional for detailed instructions on how to properly give||
2146|042|H|it.||
2146|043|H|   Use this medication regularly to get the most benefit from it.||
2146|044|H|To help you remember, take it at the same times each day.||
2146|045|B|||
2146|046|S|SIDE EFFECTS:  Loss of appetite, diarrhea, or gas may occur. If||
2146|047|S|any of these effects last or get worse, tell your doctor or||
2146|048|S|pharmacist promptly.||
2146|049|S|   Remember that this medication has been prescribed because your||
2146|050|S|doctor has judged that the benefit to you is greater than the||
2146|051|S|risk of side effects. Many people using this medication do not||
2146|052|S|have serious side effects.||
2146|053|S|   Tell your doctor right away if you have any serious side||
2146|054|S|effects, including: nausea, vomiting, headache,||
2146|055|S|drowsiness/lightheadedness, mental/mood changes (such as||
2146|056|S|confusion), tiredness, decreased hearing.||
2146|057|S|   A very serious allergic reaction to this drug is rare.||
2146|058|S|However, get medical help right away if you notice any symptoms||
2146|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2146|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2146|061|S|breathing.||
2146|062|S|   This is not a complete list of possible side effects. If you||
2146|063|S|notice other effects not listed above, contact your doctor or||
2146|064|S|pharmacist.||
2146|065|S|   In the US -||
2146|066|S|   Call your doctor for medical advice about side effects. You||
2146|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2146|068|S|www.fda.gov/medwatch.||
2146|069|S|   In Canada - Call your doctor for medical advice about side||
2146|070|S|effects. You may report side effects to Health Canada at||
2146|071|S|1-866-234-2345.||
2146|072|B|||
2146|073|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2146|074|P|pharmacist if you are allergic to it; or if you have any other||
2146|075|P|allergies. This product may contain inactive ingredients, which||
2146|076|P|can cause allergic reactions or other problems. Talk to your||
2146|077|P|pharmacist for more details.||
2146|078|P|   Before using this medication, tell your doctor or pharmacist||
2146|079|P|your medical history, especially of: disease of the pancreas,||
2146|080|P|difficulty absorbing fat from food (malabsorption), kidney||
2146|081|P|disease, liver disease.||
2146|082|P|   Before having surgery, tell your doctor or dentist about all||
2146|083|P|the products you use (including prescription drugs,||
2146|084|P|nonprescription drugs, and herbal products).||
2146|085|P|   During pregnancy, this medication should be used only when||
2146|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
2146|087|P|   It is unknown if this medication passes into breast milk.||
2146|088|P|Consult your doctor before breastfeeding.||
2146|089|B|||
2146|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2146|091|I|medications work or increase your risk for serious side effects.||
2146|092|I|This document does not contain all possible drug interactions.||
2146|093|I|Keep a list of all the products you use (including||
2146|094|I|prescription/nonprescription drugs and herbal products) and share||
2146|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
2146|096|I|the dosage of any medicines without your doctor's approval.||
2146|097|B|||
2146|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2146|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2146|100|O|poison control center right away. US residents can call||
2146|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2146|102|B|||
2146|103|N|NOTES:  Do not share this medication with others.||
2146|104|N|   Lab and/or medical tests (such as ammonia/amino acid levels,||
2146|105|N|urine tests, drug levels) should be done while you are taking||
2146|106|N|this medication. Keep all medical and lab appointments. Consult||
2146|107|N|your doctor for more details.||
2146|108|B|||
2146|109|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2146|110|D|remember. If it is near the time of the next dose, skip the||
2146|111|D|missed dose. Take your next dose at the regular time. Do not||
2146|112|D|double the dose to catch up. It is very important to take the||
2146|113|D|full amount prescribed for each 24-hour period.||
2146|114|B|||
2146|115|R|STORAGE:  Store at room temperature away from light and moisture.||
2146|116|R|Do not store in the bathroom. Different brands of this medication||
2146|117|R|may have different storage needs. Check the product package for||
2146|118|R|instructions on how to store your brand, or ask your pharmacist.||
2146|119|R|Keep all medications away from children and pets.||
2146|120|R|   Do not flush medications down the toilet or pour them into a||
2146|121|R|drain unless instructed to do so. Properly discard this product||
2146|122|R|when it is expired or no longer needed. Consult your pharmacist||
2146|123|R|or local waste disposal company.||
2146|124|B|||
2146|125|A|Information last revised September 2024.||
2146|126|A|Copyright(c) 2025 First Databank, Inc.||
2146|127|B|||
2147|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2147|002|Z|does NOT have all possible information about this product. This||
2147|003|Z|information does not assure that this product is safe, effective,||
2147|004|Z|or appropriate for you. This information is not individual||
2147|005|Z|medical advice and does not substitute for the advice of your||
2147|006|Z|health care professional. Always ask your health care||
2147|007|Z|professional for complete information about this product and your||
2147|008|Z|specific health needs.||
2147|009|B|||
2147|010|T|PRETOMANID - ORAL||
2147|011|F|(pre-TOE-ma-nid)||
2147|012|B|||
2147|013|U|USES:  This medication is used in combination with certain other||
2147|014|U|medications (such as bedaquiline, linezolid) to treat active||
2147|015|U|multi-drug-resistant tuberculosis (TB) of the lungs in certain||
2147|016|U|people. Pretomanid belongs to a class of drugs known as||
2147|017|U|antibiotics. It works by stopping the growth of the bacteria that||
2147|018|U|causes TB.||
2147|019|U|   This antibiotic treats only bacterial infections. It will not||
2147|020|U|work for viral infections (such as common cold, flu). Using any||
2147|021|U|antibiotic when it is not needed can cause it to not work for||
2147|022|U|future infections.||
2147|023|B|||
2147|024|H|HOW TO USE:  Read the Medication Guide provided by your||
2147|025|H|pharmacist before you start taking pretomanid and each time you||
2147|026|H|get a refill. This medication must be used with certain other TB||
2147|027|H|medications. Also read the Medication Guide and drug information||
2147|028|H|that comes with your other medications. If you have any||
2147|029|H|questions, ask your doctor or pharmacist.||
2147|030|H|   Take this medication by mouth with food as directed by your||
2147|031|H|doctor, usually once daily for 26 weeks. Swallow the tablet whole||
2147|032|H|with water.||
2147|033|H|   If you cannot swallow the tablet whole, you may crush the||
2147|034|H|tablet and add it to 1 teaspoon (5 milliliters) of water in a||
2147|035|H|cup. You may also place the tablet in the cup of water, wait 4 to||
2147|036|H|5 minutes, then crush any remaining solid pieces. Mix well by||
2147|037|H|stirring, then swallow the mixture right away. To make sure you||
2147|038|H|get the full dose, rinse the cup with another 1 teaspoon (5||
2147|039|H|milliliters) of water, then swallow the mixture right away. Do||
2147|040|H|not store the mixture for later use.||
2147|041|H|   The dosage is based on your medical condition and response to||
2147|042|H|treatment.||
2147|043|H|   For the best effect, take this antibiotic at evenly spaced||
2147|044|H|times. To help you remember, take this medication at the same||
2147|045|H|time every day.||
2147|046|H|   Continue to take this medication (and other TB medications)||
2147|047|H|until the full prescribed amount is finished, even if symptoms||
2147|048|H|disappear after a few days. Stopping the medication too early or||
2147|049|H|skipping doses may result in a return of the infection.||
2147|050|H|   Tell your doctor if your condition lasts or gets worse.||
2147|051|B|||
2147|052|S|SIDE EFFECTS:  Nausea, upset stomach, diarrhea, cough,||
2147|053|S|muscle/joint pain, acne, and headache may occur. If any of these||
2147|054|S|effects last or get worse, tell your doctor or pharmacist||
2147|055|S|promptly.||
2147|056|S|   Remember that this medication has been prescribed because your||
2147|057|S|doctor has judged that the benefit to you is greater than the||
2147|058|S|risk of side effects. Many people using this medication do not||
2147|059|S|have serious side effects.||
2147|060|S|   Tell your doctor right away if you have any serious side||
2147|061|S|effects, including: symptoms of liver damage (such as||
2147|062|S|nausea/vomiting that doesn't stop, loss of appetite,||
2147|063|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2147|064|S|symptoms of lactic acidosis (such as deep/fast breathing, unusual||
2147|065|S|drowsiness, nausea/vomiting that doesn't stop), numbness/tingling||
2147|066|S|of the arms/hands/legs/feet, easy bruising/bleeding, unusual||
2147|067|S|tiredness.||
2147|068|S|   Get medical help right away if you have any very serious side||
2147|069|S|effects, including: coughing up blood, chest pain, fast/irregular||
2147|070|S|heartbeat, severe dizziness, fainting, vision changes (such as||
2147|071|S|blurred vision, decreased vision).||
2147|072|S|   This medication, taken with certain other TB medications, can||
2147|073|S|commonly cause a rash that is usually not serious. However, you||
2147|074|S|may not be able to tell it apart from a rare rash that could be a||
2147|075|S|sign of a severe reaction. Get medical help right away if you||
2147|076|S|develop any rash.||
2147|077|S|   A very serious allergic reaction to this drug is rare.||
2147|078|S|However, get medical help right away if you notice any symptoms||
2147|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2147|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2147|081|S|breathing.||
2147|082|S|   This is not a complete list of possible side effects. If you||
2147|083|S|notice other effects not listed above, contact your doctor or||
2147|084|S|pharmacist.||
2147|085|S|   In the US -||
2147|086|S|   Call your doctor for medical advice about side effects. You||
2147|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2147|088|S|www.fda.gov/medwatch.||
2147|089|S|   In Canada - Call your doctor for medical advice about side||
2147|090|S|effects. You may report side effects to Health Canada at||
2147|091|S|1-866-234-2345.||
2147|092|B|||
2147|093|P|PRECAUTIONS:  Before taking pretomanid, tell your doctor or||
2147|094|P|pharmacist if you are allergic to it; or to bedaquiline; or to||
2147|095|P|linezolid; or if you have any other allergies. This product may||
2147|096|P|contain inactive ingredients, which can cause allergic reactions||
2147|097|P|or other problems. Talk to your pharmacist for more details.||
2147|098|P|   Before using this medication, tell your doctor or pharmacist||
2147|099|P|your medical history, especially of: kidney problems, liver||
2147|100|P|problems.||
2147|101|P|   This medication, taken with certain other TB medications, may||
2147|102|P|cause a condition that affects the heart rhythm (QT||
2147|103|P|prolongation). QT prolongation can rarely cause serious (rarely||
2147|104|P|fatal) fast/irregular heartbeat and other symptoms (such as||
2147|105|P|severe dizziness, fainting) that need medical attention right||
2147|106|P|away.||
2147|107|P|   The risk of QT prolongation may be increased if you have||
2147|108|P|certain medical conditions or are taking other drugs that may||
2147|109|P|cause QT prolongation. Before using pretomanid, tell your doctor||
2147|110|P|or pharmacist of all the drugs you take and if you have any of||
2147|111|P|the following conditions: certain heart problems (heart failure,||
2147|112|P|slow heartbeat, QT prolongation in the EKG), family history of||
2147|113|P|certain heart problems (QT prolongation in the EKG, sudden||
2147|114|P|cardiac death).||
2147|115|P|   Low levels of potassium or magnesium in the blood may also||
2147|116|P|increase your risk of QT prolongation. This risk may increase if||
2147|117|P|you use certain drugs (such as diuretics/"water pills") or if you||
2147|118|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2147|119|P|Talk to your doctor about using this medication combination||
2147|120|P|safely.||
2147|121|P|   Alcohol may increase the risk of liver disease. Avoid||
2147|122|P|alcoholic beverages while using this combination of medications.||
2147|123|P|   Pretomanid may cause live bacterial vaccines (such as typhoid||
2147|124|P|vaccine) to not work well. Tell your health care professional||
2147|125|P|that you are using pretomanid before having any||
2147|126|P|immunizations/vaccinations.||
2147|127|P|   Older adults may be more sensitive to the side effects of this||
2147|128|P|drug, especially QT prolongation (see above).||
2147|129|P|   Before having surgery, tell your doctor or dentist about all||
2147|130|P|the products you use (including prescription drugs,||
2147|131|P|nonprescription drugs, and herbal products).||
2147|132|P|   During pregnancy, this medication should be used only when||
2147|133|P|clearly needed. Discuss the risks and benefits with your doctor.||
2147|134|P|   It is unknown if this drug passes into breast milk. Consult||
2147|135|P|your doctor before breastfeeding.||
2147|136|B|||
2147|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2147|138|I|medications work or increase your risk for serious side effects.||
2147|139|I|This document does not contain all possible drug interactions.||
2147|140|I|Keep a list of all the products you use (including||
2147|141|I|prescription/nonprescription drugs and herbal products) and share||
2147|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
2147|143|I|the dosage of any medicines without your doctor's approval.||
2147|144|I|   Other medications can affect the removal of pretomanid from||
2147|145|I|your body, which may affect how pretomanid works. Examples||
2147|146|I|include efavirenz, rifamycins (such as rifampin, rifabutin), St.||
2147|147|I|John's wort, drugs used to treat seizures (such as carbamazepine,||
2147|148|I|phenytoin), among others.||
2147|149|B|||
2147|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2147|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2147|152|O|poison control center right away. US residents can call||
2147|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2147|154|B|||
2147|155|N|NOTES:  Do not share this medication with others.||
2147|156|N|   This medication has been prescribed for your current condition||
2147|157|N|only. Do not use it later for another infection unless your||
2147|158|N|doctor tells you to.||
2147|159|N|   Lab and/or medical tests (such as complete blood counts, liver||
2147|160|N|function, EKG, potassium/calcium/magnesium levels, eye exams)||
2147|161|N|should be done before you start taking this medication and while||
2147|162|N|you are taking it. Keep all medical and lab appointments.||
2147|163|B|||
2147|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2147|165|D|remember. If it is near the time of the next dose, skip the||
2147|166|D|missed dose. Take your next dose at the regular time. Do not||
2147|167|D|double the dose to catch up. Your doctor may direct you to keep||
2147|168|D|taking this medication with other TB medications for a longer||
2147|169|D|time (longer than 26 weeks) if you miss doses. Carefully follow||
2147|170|D|your doctor's directions.||
2147|171|B|||
2147|172|R|STORAGE:  Store in the original container at room temperature||
2147|173|R|away from light and moisture. Do not store in the bathroom.||
2147|174|R|Tightly close the bottle when not in use. Keep all medications||
2147|175|R|away from children and pets.||
2147|176|R|   Do not flush medications down the toilet or pour them into a||
2147|177|R|drain unless instructed to do so. Properly discard this product||
2147|178|R|when it is expired or no longer needed. Consult your pharmacist||
2147|179|R|or local waste disposal company.||
2147|180|B|||
2147|181|A|Information last revised November 2024.||
2147|182|A|Copyright(c) 2025 First Databank, Inc.||
2147|183|B|||
2148|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2148|002|Z|does NOT have all possible information about this product. This||
2148|003|Z|information does not assure that this product is safe, effective,||
2148|004|Z|or appropriate for you. This information is not individual||
2148|005|Z|medical advice and does not substitute for the advice of your||
2148|006|Z|health care professional. Always ask your health care||
2148|007|Z|professional for complete information about this product and your||
2148|008|Z|specific health needs.||
2148|009|B|||
2148|010|T|ZANUBRUTINIB - ORAL||
2148|011|F|(ZAN-ue-BROO-ti-nib)||
2148|012|B|||
2148|013|C|COMMON BRAND NAME(S): Brukinsa||
2148|014|B|||
2148|015|U|USES:  This medication is used to treat certain cancers (mantle||
2148|016|U|cell lymphoma, marginal zone lymphoma, Waldenstrom's||
2148|017|U|macroglobulinemia, chronic lymphocytic leukemia, small||
2148|018|U|lymphocytic lymphoma, follicular lymphoma). Zanubrutinib belongs||
2148|019|U|to a class of drugs known as kinase inhibitors. It works by||
2148|020|U|slowing or stopping the growth of cancer cells.||
2148|021|B|||
2148|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2148|023|H|from your pharmacist before you start taking zanubrutinib and||
2148|024|H|each time you get a refill. If you have any questions, ask your||
2148|025|H|doctor or pharmacist.||
2148|026|H|   Take this medication by mouth with or without food as directed||
2148|027|H|by your doctor, usually once or twice daily.||
2148|028|H|   If you are taking the capsule form of this medication, swallow||
2148|029|H|the capsules whole with water. Do not open, break, or chew the||
2148|030|H|capsules.||
2148|031|H|   If you are taking the tablet form of this medication, do not||
2148|032|H|crush or chew the tablets. Also, do not split the tablets unless||
2148|033|H|they have a score line and your doctor or pharmacist tells you to||
2148|034|H|do so. Swallow the tablets with water.||
2148|035|H|   The dosage is based on your medical condition, response to||
2148|036|H|treatment, and other medications you may be taking. Be sure to||
2148|037|H|tell your doctor and pharmacist about all the products you use||
2148|038|H|(including prescription drugs, nonprescription drugs, and herbal||
2148|039|H|products).||
2148|040|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2148|041|H|using this medication unless your doctor or pharmacist says you||
2148|042|H|may do so safely. Grapefruit can increase the chance of side||
2148|043|H|effects with this medicine. Ask your doctor or pharmacist for||
2148|044|H|more details.||
2148|045|H|   Use this medication regularly to get the most benefit from it.||
2148|046|H|To help you remember, take it at the same time(s) each day.||
2148|047|H|   Do not increase your dose or use this drug more often or for||
2148|048|H|longer than prescribed. Your condition will not improve any||
2148|049|H|faster, and your risk of serious side effects will increase.||
2148|050|H|   Since this drug can be absorbed through the skin and lungs and||
2148|051|H|may harm an unborn baby, women who are pregnant or who may become||
2148|052|H|pregnant should not handle this medication or breathe the dust||
2148|053|H|from the tablets or capsules.||
2148|054|B|||
2148|055|S|SIDE EFFECTS:  Diarrhea, muscle/joint pain, tiredness, dizziness,||
2148|056|S|or constipation may occur. If any of these effects last or get||
2148|057|S|worse, tell your doctor or pharmacist promptly.||
2148|058|S|   People using this medication may have serious side effects.||
2148|059|S|However, you have been prescribed this drug because your doctor||
2148|060|S|has judged that the benefit to you is greater than the risk of||
2148|061|S|side effects. Careful monitoring by your doctor may decrease your||
2148|062|S|risk.||
2148|063|S|   This medication may raise your blood pressure. Check your||
2148|064|S|blood pressure regularly and tell your doctor if the results are||
2148|065|S|high.||
2148|066|S|   Tell your doctor right away if you have any serious side||
2148|067|S|effects, including: easy bruising/bleeding, fast/irregular||
2148|068|S|heartbeat, signs of liver disease (such as nausea/vomiting that||
2148|069|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
2148|070|S|eyes/skin, dark urine).||
2148|071|S|   Get medical help right away if you have any very serious side||
2148|072|S|effects, including: black/bloody stools, vomit that looks like||
2148|073|S|coffee grounds, pink/bloody urine, confusion, severe headache,||
2148|074|S|fainting, shortness of breath.||
2148|075|S|   This medication may increase the risk of other cancers||
2148|076|S|(especially skin cancer). Limit your time in the sun. Use||
2148|077|S|sunscreen and wear protective clothing when outdoors. Consult||
2148|078|S|your doctor for more details.||
2148|079|S|   This medication may lower your ability to fight infections.||
2148|080|S|This may make you more likely to get a serious (rarely fatal)||
2148|081|S|infection or make any infection you have worse. Tell your doctor||
2148|082|S|right away if you have any signs of infection (such as sore||
2148|083|S|throat that doesn't go away, fever, chills).||
2148|084|S|   A very serious allergic reaction to this drug is rare.||
2148|085|S|However, get medical help right away if you notice any symptoms||
2148|086|S|of a serious allergic reaction, including: rash, itching/swelling||
2148|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2148|088|S|breathing.||
2148|089|S|   This is not a complete list of possible side effects. If you||
2148|090|S|notice other effects not listed above, contact your doctor or||
2148|091|S|pharmacist.||
2148|092|S|   In the US -||
2148|093|S|   Call your doctor for medical advice about side effects. You||
2148|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2148|095|S|www.fda.gov/medwatch.||
2148|096|S|   In Canada - Call your doctor for medical advice about side||
2148|097|S|effects. You may report side effects to Health Canada at||
2148|098|S|1-866-234-2345.||
2148|099|B|||
2148|100|P|PRECAUTIONS:  Before taking zanubrutinib, tell your doctor or||
2148|101|P|pharmacist if you are allergic to it; or if you have any other||
2148|102|P|allergies. This product may contain inactive ingredients, which||
2148|103|P|can cause allergic reactions or other problems. Talk to your||
2148|104|P|pharmacist for more details.||
2148|105|P|   Before using this medication, tell your doctor or pharmacist||
2148|106|P|your medical history, especially of: bleeding/blood problems,||
2148|107|P|heart problems (such as irregular heartbeat), high blood||
2148|108|P|pressure, liver problems.||
2148|109|P|   Zanubrutinib can make you more likely to get infections or may||
2148|110|P|make current infections worse. Stay away from anyone who has an||
2148|111|P|infection that may easily spread (such as chickenpox, COVID-19,||
2148|112|P|measles, flu). Talk to your doctor if you have been exposed to an||
2148|113|P|infection or for more details.||
2148|114|P|   Tell your health care professional that you are using||
2148|115|P|zanubrutinib before having any immunizations/vaccinations. Avoid||
2148|116|P|contact with people who have recently received live vaccines||
2148|117|P|(such as flu vaccine inhaled through the nose).||
2148|118|P|   To lower the chance of getting cut, bruised, or injured, use||
2148|119|P|caution with sharp objects like razors and nail cutters, and||
2148|120|P|avoid activities such as contact sports.||
2148|121|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2148|122|P|can make you more dizzy. Do not drive, use machinery, or do||
2148|123|P|anything that needs alertness until you can do it safely. Limit||
2148|124|P|alcoholic beverages. Talk to your doctor if you are using||
2148|125|P|marijuana (cannabis).||
2148|126|P|   Before having surgery, tell your doctor or dentist about all||
2148|127|P|the products you use (including prescription drugs,||
2148|128|P|nonprescription drugs, and herbal products).||
2148|129|P|   Tell your doctor if you are pregnant or plan to become||
2148|130|P|pregnant. You should not become pregnant while using||
2148|131|P|zanubrutinib. Zanubrutinib may harm an unborn baby. Your doctor||
2148|132|P|should order a pregnancy test before you start this medication.||
2148|133|P|Women using this medication should ask about reliable forms of||
2148|134|P|birth control during treatment and for 1 week after the last||
2148|135|P|dose. Men using this medication should ask about reliable forms||
2148|136|P|of birth control during treatment and for some time after the||
2148|137|P|last dose. If you or your partner becomes pregnant, talk to your||
2148|138|P|doctor right away about the risks and benefits of this||
2148|139|P|medication.||
2148|140|P|   Since this drug can be absorbed through the skin and lungs and||
2148|141|P|may harm an unborn baby, women who are pregnant or who may become||
2148|142|P|pregnant should not handle this medication or breathe the dust||
2148|143|P|from the tablets or capsules.||
2148|144|P|   It is unknown if this drug passes into breast milk. Because of||
2148|145|P|the possible risk to the infant, breastfeeding is not recommended||
2148|146|P|while using this drug and for at least 2 weeks after the last||
2148|147|P|dose. Consult your doctor before breastfeeding.||
2148|148|B|||
2148|149|I|DRUG INTERACTIONS:  See also How to Use section.||
2148|150|I|   Drug interactions may change how your medications work or||
2148|151|I|increase your risk for serious side effects. This document does||
2148|152|I|not contain all possible drug interactions. Keep a list of all||
2148|153|I|the products you use (including prescription/nonprescription||
2148|154|I|drugs and herbal products) and share it with your doctor and||
2148|155|I|pharmacist. Do not start, stop, or change the dosage of any||
2148|156|I|medicines without your doctor's approval.||
2148|157|I|   Other medications can affect the removal of zanubrutinib from||
2148|158|I|your body, which may affect how zanubrutinib works. Examples||
2148|159|I|include efavirenz, rifamycins (such as rifampin, rifabutin), St.||
2148|160|I|John's wort, drugs used to treat seizures (such as carbamazepine,||
2148|161|I|phenytoin), among others.||
2148|162|B|||
2148|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2148|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2148|165|O|poison control center right away. US residents can call||
2148|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2148|167|B|||
2148|168|N|NOTES:  Do not share this medication with others.||
2148|169|N|   Lab and/or medical tests (such as complete blood count, liver||
2148|170|N|function) should be done before you start taking this medication||
2148|171|N|and while you are taking it. Keep all medical and lab||
2148|172|N|appointments.||
2148|173|B|||
2148|174|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2148|175|D|remember. If you don't remember until the next day, skip the||
2148|176|D|missed dose. Take your next dose at the regular time. Do not||
2148|177|D|double the dose to catch up.||
2148|178|B|||
2148|179|R|STORAGE:  Store at room temperature away from light and moisture.||
2148|180|R|Do not store in the bathroom. Keep all medications away from||
2148|181|R|children and pets.||
2148|182|R|   Do not flush medications down the toilet or pour them into a||
2148|183|R|drain unless instructed to do so. Properly discard this product||
2148|184|R|when it is expired or no longer needed. Consult your pharmacist||
2148|185|R|or local waste disposal company.||
2148|186|B|||
2148|187|M|MEDICAL ALERT:  Your condition can cause complications in a||
2148|188|M|medical emergency. For information about enrolling in MedicAlert,||
2148|189|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2148|190|B|||
2148|191|A|Information last revised April 2025.||
2148|192|A|Copyright(c) 2025 First Databank, Inc.||
2148|193|B|||
2149|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2149|002|Z|does NOT have all possible information about this product. This||
2149|003|Z|information does not assure that this product is safe, effective,||
2149|004|Z|or appropriate for you. This information is not individual||
2149|005|Z|medical advice and does not substitute for the advice of your||
2149|006|Z|health care professional. Always ask your health care||
2149|007|Z|professional for complete information about this product and your||
2149|008|Z|specific health needs.||
2149|009|B|||
2149|010|T|MINOCYCLINE FOAM - TOPICAL||
2149|011|F|(MIN-oh-SYE-kleen)||
2149|012|B|||
2149|013|C|COMMON BRAND NAME(S): Amzeeq||
2149|014|B|||
2149|015|U|USES:  This medication is used to treat acne or rosacea.||
2149|016|U|Minocycline belongs to a class of drugs known as tetracycline||
2149|017|U|antibiotics. However, it is not used to treat skin infections. It||
2149|018|U|helps decrease pimples and red bumps that happen with acne or||
2149|019|U|rosacea.||
2149|020|B|||
2149|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2149|022|H|Instructions for Use provided by your pharmacist before you start||
2149|023|H|using minocycline foam and each time you get a refill. If you||
2149|024|H|have any questions, ask your doctor or pharmacist.||
2149|025|H|   Apply this product as directed by your doctor, usually once||
2149|026|H|daily, at least 1 hour before bedtime. Do not bathe, shower, or||
2149|027|H|swim for at least 1 hour after application.||
2149|028|H|   Before first use, allow the container to warm to room||
2149|029|H|temperature. Do not warm up this medication any other way such as||
2149|030|H|by heating in the microwave or placing in hot water. Wash your||
2149|031|H|face gently with mild cleanser, rinse with water, and pat dry.||
2149|032|H|Shake the container well before each use. Remove the cap, then||
2149|033|H|press the top of the can to dispense a small amount of foam||
2149|034|H|(about the size of a cherry) onto your fingertips. If you are||
2149|035|H|using this medication to treat rosacea, apply and gently rub the||
2149|036|H|foam over your entire face. If you are using this medication to||
2149|037|H|treat acne, apply and gently rub the foam into the affected||
2149|038|H|area(s) on your face. If you also have acne on other parts of||
2149|039|H|your body (such as your neck, shoulders, arms, back, or chest),||
2149|040|H|also apply the foam to these areas. Wash your hands after||
2149|041|H|applying this medication. This product may stain fabric.||
2149|042|H|   This medication is for use on the skin only. To avoid||
2149|043|H|irritation, do not let this medication come into contact with||
2149|044|H|your eyes, inside your nose/mouth, or any broken skin (such as||
2149|045|H|cuts, scrapes, rashes). If you do get the medication in those||
2149|046|H|areas, flush the area with cool water.||
2149|047|H|   This product is flammable until dry. Avoid smoking or being||
2149|048|H|near open flames while using the medication and until the||
2149|049|H|medication has dried.||
2149|050|H|   Use this medication regularly to get the most benefit from it.||
2149|051|H|To help you remember, use it at the same time each day.||
2149|052|H|   Tell your doctor if your condition does not get better or if||
2149|053|H|it gets worse.||
2149|054|B|||
2149|055|S|SIDE EFFECTS:  Skin redness, dryness, or itching may occur. Skin||
2149|056|S|darkening that may be due to acne can also occur. If any of these||
2149|057|S|effects last or get worse, tell your doctor or pharmacist||
2149|058|S|promptly.||
2149|059|S|   Remember that this medication has been prescribed because your||
2149|060|S|doctor has judged that the benefit to you is greater than the||
2149|061|S|risk of side effects. Many people using this medication do not||
2149|062|S|have serious side effects.||
2149|063|S|   Although these effects are unlikely when this medication is||
2149|064|S|applied to the skin, serious side effects have rarely occurred||
2149|065|S|with minocycline taken by mouth. Tell your doctor right away if||
2149|066|S|you have any serious side effects, including: joint||
2149|067|S|stiffness/pain/swelling, signs of kidney problems (such as change||
2149|068|S|in the amount of urine), signs of liver problems (such as loss of||
2149|069|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2149|070|S|urine), discoloration of skin/scars/lips/gums, yellow-gray-brown||
2149|071|S|tooth discoloration.||
2149|072|S|   This medication may rarely cause a severe intestinal condition||
2149|073|S|due to a bacteria called C. difficile. This condition may occur||
2149|074|S|during treatment or weeks to months after treatment has stopped.||
2149|075|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2149|076|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2149|077|S|stool.||
2149|078|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2149|079|S|products because they may make symptoms worse.||
2149|080|S|   This medication may sometimes cause oral thrush or a new yeast||
2149|081|S|infection. Contact your doctor if you notice white patches in||
2149|082|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2149|083|S|   Minocycline may rarely cause increased pressure around the||
2149|084|S|brain (intracranial hypertension-IH). The risk of this side||
2149|085|S|effect is greater for women of childbearing age who are||
2149|086|S|overweight or who have had IH in the past. If IH develops, it||
2149|087|S|usually goes away after minocycline is stopped; however, there is||
2149|088|S|a chance of permanent vision loss or blindness. Get medical help||
2149|089|S|right away if you have: a headache that is severe or doesn't go||
2149|090|S|away, vision changes (such as blurred/double vision, decreased||
2149|091|S|vision, sudden blindness), nausea/vomiting that doesn't stop.||
2149|092|S|   A very serious allergic reaction to this drug is rare.||
2149|093|S|However, get medical help right away if you notice any symptoms||
2149|094|S|of a serious allergic reaction, including: fever, new or||
2149|095|S|worsening lymph node swelling, rash, itching/swelling (especially||
2149|096|S|of the face/tongue/throat), severe dizziness, trouble breathing.||
2149|097|S|   This is not a complete list of possible side effects. If you||
2149|098|S|notice other effects not listed above, contact your doctor or||
2149|099|S|pharmacist.||
2149|100|S|   In the US -||
2149|101|S|   Call your doctor for medical advice about side effects. You||
2149|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2149|103|S|www.fda.gov/medwatch.||
2149|104|S|   In Canada - Call your doctor for medical advice about side||
2149|105|S|effects. You may report side effects to Health Canada at||
2149|106|S|1-866-234-2345.||
2149|107|B|||
2149|108|P|PRECAUTIONS:  Before using minocycline foam, tell your doctor or||
2149|109|P|pharmacist if you are allergic to it; or to other tetracyclines||
2149|110|P|(such as doxycycline); or if you have any other allergies. This||
2149|111|P|product may contain inactive ingredients, which can cause||
2149|112|P|allergic reactions or other problems. Talk to your pharmacist for||
2149|113|P|more details.||
2149|114|P|   Before using this medication, tell your doctor or pharmacist||
2149|115|P|your medical history.||
2149|116|P|   This medication may make you more sensitive to the sun. Limit||
2149|117|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2149|118|P|sunscreen and wear protective clothing when outdoors. Tell your||
2149|119|P|doctor right away if you get sunburned or have skin||
2149|120|P|blisters/redness.||
2149|121|P|   This drug, when taken by mouth, can make you dizzy. Alcohol or||
2149|122|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
2149|123|P|machinery, or do anything that needs alertness until you can do||
2149|124|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2149|125|P|are using marijuana (cannabis).||
2149|126|P|   Before having surgery, tell your doctor or dentist about all||
2149|127|P|the products you use (including prescription drugs,||
2149|128|P|nonprescription drugs, and herbal products).||
2149|129|P|   Children younger than 8 years may be more sensitive to the||
2149|130|P|side effects of minocycline, especially tooth discoloration.||
2149|131|P|Tooth discoloration has also occurred in older children and in||
2149|132|P|young adults. Discuss the risks and benefits of this medication||
2149|133|P|with the doctor.||
2149|134|P|   During pregnancy, this medication should be used only when||
2149|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
2149|136|P|   It is unknown if minocycline foam passes into breast milk.||
2149|137|P|Consult your doctor before breastfeeding.||
2149|138|B|||
2149|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2149|140|I|medications work or increase your risk for serious side effects.||
2149|141|I|This document does not contain all possible drug interactions.||
2149|142|I|Keep a list of all the products you use (including||
2149|143|I|prescription/nonprescription drugs and herbal products) and share||
2149|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
2149|145|I|the dosage of any medicines without your doctor's approval.||
2149|146|I|   This medication may interfere with certain lab tests, possibly||
2149|147|I|causing false test results. Make sure lab personnel and all your||
2149|148|I|doctors know you use this drug.||
2149|149|B|||
2149|150|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2149|151|O|has overdosed and has serious symptoms such as passing out or||
2149|152|O|trouble breathing, call 911. Otherwise, call a poison control||
2149|153|O|center right away. US residents can call 1-800-222-1222. Canada||
2149|154|O|residents can call 1-844-764-7669.||
2149|155|B|||
2149|156|N|NOTES:  Do not share this medication with others.||
2149|157|B|||
2149|158|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2149|159|D|If it is near the time of the next dose, skip the missed dose.||
2149|160|D|Use your next dose at the regular time. Do not double the dose to||
2149|161|D|catch up.||
2149|162|B|||
2149|163|R|STORAGE:  Store at room temperature. Do not store in the||
2149|164|R|refrigerator. This product is flammable. Keep it away from heat||
2149|165|R|and open flame. Do not puncture or burn the container. Once the||
2149|166|R|container is opened, this medication expires after 90 days. Keep||
2149|167|R|all medications away from children and pets.||
2149|168|R|   Do not flush medications down the toilet or pour them into a||
2149|169|R|drain unless instructed to do so. Properly discard this product||
2149|170|R|when it is expired or no longer needed. Consult your pharmacist||
2149|171|R|or local waste disposal company.||
2149|172|B|||
2149|173|A|Information last revised July 2025.||
2149|174|A|Copyright(c) 2025 First Databank, Inc.||
2149|175|B|||
2150|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2150|002|Z|does NOT have all possible information about this product. This||
2150|003|Z|information does not assure that this product is safe, effective,||
2150|004|Z|or appropriate for you. This information is not individual||
2150|005|Z|medical advice and does not substitute for the advice of your||
2150|006|Z|health care professional. Always ask your health care||
2150|007|Z|professional for complete information about this product and your||
2150|008|Z|specific health needs.||
2150|009|B|||
2150|010|T|ALEMTUZUMAB (ANTI-CANCER) - INJECTION||
2150|011|F|(AL-em-TOOZ-ue-mab)||
2150|012|B|||
2150|013|C|COMMON BRAND NAME(S): Campath||
2150|014|B|||
2150|015|W|WARNING:  This medication may cause very serious (rarely fatal)||
2150|016|W|blood disorders (decreased bone marrow function leading to low||
2150|017|W|number of blood cells such as red cells, white cells, and||
2150|018|W|platelets). This effect can cause anemia, decrease your body's||
2150|019|W|ability to fight an infection, or cause easy bruising/bleeding.||
2150|020|W|Tell your doctor right away if you develop any of the following||
2150|021|W|symptoms: signs of infection (such as sore throat that doesn't go||
2150|022|W|away, fever, chills, swollen lymph nodes), easy||
2150|023|W|bruising/bleeding, coughing up blood, shortness of breath,||
2150|024|W|unusual tiredness, fast/pounding heartbeat.||
2150|025|W|   Serious (rarely fatal) infusion reactions may happen during||
2150|026|W|the infusion of this drug and for a short time afterward. These||
2150|027|W|reactions occur more often during the first week of treatment.||
2150|028|W|Your doctor will prescribe other medications (such as||
2150|029|W|acetaminophen, diphenhydramine, corticosteroids) before each||
2150|030|W|treatment to help prevent these side effects. Tell your doctor||
2150|031|W|right away if you have any symptoms of infusion reactions such as||
2150|032|W|fever, chills, flushing, dizziness, shortness of breath, nausea,||
2150|033|W|vomiting, or mild rash/itching. Your doctor may give you other||
2150|034|W|medications to help with these side effects.||
2150|035|B|||
2150|036|U|USES:  Alemtuzumab is used to treat a certain type of leukemia||
2150|037|U|(B-cell chronic lymphocytic leukemia, also known as B-CLL). This||
2150|038|U|medication works by slowing or stopping the growth of cancer||
2150|039|U|cells.||
2150|040|B|||
2150|041|H|HOW TO USE:  This medication is given by injection into a vein||
2150|042|H|over 2 hours by a health care professional. The dosage is based||
2150|043|H|on your medical condition and response to treatment. Your doctor||
2150|044|H|will increase your dose slowly to decrease the risk of side||
2150|045|H|effects.||
2150|046|H|   Before you receive this medication, your doctor will direct||
2150|047|H|you to take other medications (such as acetaminophen,||
2150|048|H|diphenhydramine, corticosteroids, antibiotics, antiviral||
2150|049|H|medications) to help prevent side effects and infection. Use||
2150|050|H|these additional medications exactly as prescribed by your||
2150|051|H|doctor.||
2150|052|B|||
2150|053|S|SIDE EFFECTS:  See also Warning section.||
2150|054|S|   Diarrhea, stomach/abdominal pain, tiredness, headache, shaking||
2150|055|S|(tremor), trouble sleeping, or mouth sores may occur. If any of||
2150|056|S|these effects last or get worse, tell your doctor or pharmacist||
2150|057|S|promptly.||
2150|058|S|   People using this medication may have serious side effects.||
2150|059|S|However, you have been prescribed this drug because your doctor||
2150|060|S|has judged that the benefit to you is greater than the risk of||
2150|061|S|side effects. Careful monitoring by your doctor may decrease your||
2150|062|S|risk.||
2150|063|S|   Tell your doctor right away if you have any serious side||
2150|064|S|effects, including: mental/mood changes (such as depression,||
2150|065|S|anxiety), muscle/bone pain, numbness/tingling of arms/legs,||
2150|066|S|fast/slow/irregular heartbeat, unusual weight changes, signs of||
2150|067|S|kidney problems (such as change in the amount of urine, painful||
2150|068|S|urination, pink/bloody urine, swelling ankles/feet), signs of||
2150|069|S|liver disease (such as nausea/vomiting that doesn't stop, loss of||
2150|070|S|appetite, severe stomach/abdominal pain, yellowing eyes/skin).||
2150|071|S|   This medication may increase your risk of getting a rare but||
2150|072|S|very serious (possibly fatal) brain infection (progressive||
2150|073|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2150|074|S|if you have any of these side effects: clumsiness, loss of||
2150|075|S|coordination/balance, weakness, sudden change in your thinking||
2150|076|S|(such as confusion, difficulty concentrating, memory loss),||
2150|077|S|difficulty talking/walking, seizure, vision changes.||
2150|078|S|   Get medical help right away if you have any very serious side||
2150|079|S|effects, including: fainting, chest/jaw/left arm pain, neck pain,||
2150|080|S|weakness on one side of the body, sudden severe headache.||
2150|081|S|   A very serious allergic reaction to this drug is rare.||
2150|082|S|However, get medical help right away if you notice any symptoms||
2150|083|S|of a serious allergic reaction, including: rash, itching/swelling||
2150|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2150|085|S|breathing.||
2150|086|S|   This is not a complete list of possible side effects. If you||
2150|087|S|notice other effects not listed above, contact your doctor or||
2150|088|S|pharmacist.||
2150|089|S|   In the US -||
2150|090|S|   Call your doctor for medical advice about side effects. You||
2150|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2150|092|S|www.fda.gov/medwatch.||
2150|093|S|   In Canada - Call your doctor for medical advice about side||
2150|094|S|effects. You may report side effects to Health Canada at||
2150|095|S|1-866-234-2345.||
2150|096|B|||
2150|097|P|PRECAUTIONS:  Before receiving this alemtuzumab, tell your doctor||
2150|098|P|or pharmacist if you are allergic to it; or if you have any other||
2150|099|P|allergies. This product may contain inactive ingredients, which||
2150|100|P|can cause allergic reactions or other problems. Talk to your||
2150|101|P|pharmacist for more details.||
2150|102|P|   Before using this medication, tell your doctor or pharmacist||
2150|103|P|your medical history, especially of: immune system problems (such||
2150|104|P|as HIV), recent/current infections (such as tuberculosis),||
2150|105|P|bleeding/blood problems, high blood pressure, stroke, other||
2150|106|P|cancers, kidney problems, heart problems, blood vessel problems||
2150|107|P|(such as tears in arteries), thyroid problems.||
2150|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2150|109|P|can make you more dizzy. Do not drive, use machinery, or do||
2150|110|P|anything that needs alertness until you can do it safely. Limit||
2150|111|P|alcoholic beverages. Talk to your doctor if you are using||
2150|112|P|marijuana (cannabis).||
2150|113|P|   Before having surgery, tell your doctor or dentist about all||
2150|114|P|the products you use (including prescription drugs,||
2150|115|P|nonprescription drugs, and herbal products).||
2150|116|P|   Before receiving a blood transfusion, tell your doctor that||
2150|117|P|you are using this medication.||
2150|118|P|   Tell your health care professional that you are using||
2150|119|P|alemtuzumab before having any immunizations/vaccinations. Avoid||
2150|120|P|contact with people who have recently received live vaccines||
2150|121|P|(such as flu vaccine inhaled through the nose).||
2150|122|P|   Wash your hands well to prevent the spread of infections.||
2150|123|P|   This medication also increases your risk of getting a very||
2150|124|P|serious infection caused by a bacteria called listeria. During||
2150|125|P|treatment and for some time after treatment with this medication,||
2150|126|P|either avoid food that may contain listeria (such as deli meat,||
2150|127|P|unpasteurized milk and cheese products, soft cheeses, undercooked||
2150|128|P|meat/seafood/poultry), or make sure you heat it well. Ask your||
2150|129|P|doctor for more details.||
2150|130|P|   To lower the chance of getting cut, bruised, or injured, use||
2150|131|P|caution with sharp objects like razors and nail cutters, and||
2150|132|P|avoid activities such as contact sports.||
2150|133|P|   Tell your doctor if you are pregnant or plan to become||
2150|134|P|pregnant. You should not become pregnant while using alemtuzumab.||
2150|135|P|Alemtuzumab may harm an unborn baby. Your doctor should order a||
2150|136|P|pregnancy test before you start this medication. Ask about||
2150|137|P|reliable forms of birth control while using this medication and||
2150|138|P|for at least 3 months after the last dose. If you become||
2150|139|P|pregnant, talk to your doctor right away about the risks and||
2150|140|P|benefits of this medication.||
2150|141|P|   It is unknown if this drug passes into breast milk. Because of||
2150|142|P|the possible risk to the infant, breastfeeding is not recommended||
2150|143|P|while using this drug and for at least 3 months after the last||
2150|144|P|dose. Consult your doctor before breastfeeding.||
2150|145|B|||
2150|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2150|147|I|medications work or increase your risk for serious side effects.||
2150|148|I|This document does not contain all possible drug interactions.||
2150|149|I|Keep a list of all the products you use (including||
2150|150|I|prescription/nonprescription drugs and herbal products) and share||
2150|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
2150|152|I|the dosage of any medicines without your doctor's approval.||
2150|153|I|   Some products that may interact with this drug are: other||
2150|154|I|drugs that weaken the immune system/increase the risk of||
2150|155|I|infection (such as natalizumab, rituximab).||
2150|156|B|||
2150|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2150|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2150|159|O|poison control center right away. US residents can call||
2150|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2150|161|O|Symptoms of overdose may include: trouble breathing.||
2150|162|B|||
2150|163|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2150|164|N|kidney/liver/thyroid function, blood pressure) should be done||
2150|165|N|before treatment, while you are receiving this medication, and||
2150|166|N|for some time after treatment is completed. Keep all medical and||
2150|167|N|lab appointments. Consult your doctor for more details.||
2150|168|B|||
2150|169|D|MISSED DOSE:  It is important to get each dose of this medication||
2150|170|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2150|171|D|right away for a new dosing schedule.||
2150|172|B|||
2150|173|R|STORAGE:  Not applicable. This medication is given in a hospital||
2150|174|R|or clinic and will not be stored at home.||
2150|175|B|||
2150|176|M|MEDICAL ALERT:  Your condition can cause complications in a||
2150|177|M|medical emergency. For information about enrolling in MedicAlert,||
2150|178|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2150|179|B|||
2150|180|A|Information last revised April 2025.||
2150|181|A|Copyright(c) 2025 First Databank, Inc.||
2150|182|B|||
2151|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2151|002|Z|does NOT have all possible information about this product. This||
2151|003|Z|information does not assure that this product is safe, effective,||
2151|004|Z|or appropriate for you. This information is not individual||
2151|005|Z|medical advice and does not substitute for the advice of your||
2151|006|Z|health care professional. Always ask your health care||
2151|007|Z|professional for complete information about this product and your||
2151|008|Z|specific health needs.||
2151|009|B|||
2151|010|T|NUSINERSEN - INJECTION||
2151|011|F|(NUE-si-NER-sen)||
2151|012|B|||
2151|013|C|COMMON BRAND NAME(S): Spinraza||
2151|014|B|||
2151|015|U|USES:  This medication is used to treat a certain nervous system||
2151|016|U|disorder that can lead to muscle weakness and muscle loss (spinal||
2151|017|U|muscular atrophy). Nusinersen may help improve motor functions||
2151|018|U|(such as crawling, walking).||
2151|019|B|||
2151|020|H|HOW TO USE:  This medication is given by injection into the area||
2151|021|H|around the spinal cord (intrathecal) by a health care||
2151|022|H|professional. It is given as directed by your doctor. Your doctor||
2151|023|H|may direct you to get this medication more often when you start||
2151|024|H|this medication. Follow your doctor's instructions carefully.||
2151|025|H|   Use this medication regularly to get the most benefit from it.||
2151|026|H|To help you remember, mark your calendar with a reminder.||
2151|027|H|   Tell your doctor if your condition gets worse.||
2151|028|B|||
2151|029|S|SIDE EFFECTS:  Back pain, headache, or vomiting may occur. If any||
2151|030|S|of these effects last or get worse, tell your doctor or||
2151|031|S|pharmacist promptly.||
2151|032|S|   Remember that this medication has been prescribed because your||
2151|033|S|doctor has judged that the benefit to you is greater than the||
2151|034|S|risk of side effects. Many people using this medication do not||
2151|035|S|have serious side effects.||
2151|036|S|   Tell your doctor right away if you have any serious side||
2151|037|S|effects, including: easy bruising/bleeding, signs of kidney||
2151|038|S|problems (such as pink/bloody urine, change in the amount of||
2151|039|S|urine).||
2151|040|S|   A very serious allergic reaction to this drug is rare.||
2151|041|S|However, get medical help right away if you notice any symptoms||
2151|042|S|of a serious allergic reaction, including: rash, itching/swelling||
2151|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2151|044|S|breathing.||
2151|045|S|   This is not a complete list of possible side effects. If you||
2151|046|S|notice other effects not listed above, contact your doctor or||
2151|047|S|pharmacist.||
2151|048|S|   In the US -||
2151|049|S|   Call your doctor for medical advice about side effects. You||
2151|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2151|051|S|www.fda.gov/medwatch.||
2151|052|S|   In Canada - Call your doctor for medical advice about side||
2151|053|S|effects. You may report side effects to Health Canada at||
2151|054|S|1-866-234-2345.||
2151|055|B|||
2151|056|P|PRECAUTIONS:  Before using nusinersen, tell your doctor or||
2151|057|P|pharmacist if you are allergic to it; or if you have any other||
2151|058|P|allergies. This product may contain inactive ingredients, which||
2151|059|P|can cause allergic reactions or other problems. Talk to your||
2151|060|P|pharmacist for more details.||
2151|061|P|   Before using this medication, tell your doctor or pharmacist||
2151|062|P|your medical history, especially of: kidney disease, bleeding||
2151|063|P|disorders.||
2151|064|P|   Before having surgery, tell your doctor or dentist about all||
2151|065|P|the products you use (including prescription drugs,||
2151|066|P|nonprescription drugs, and herbal products).||
2151|067|P|   During pregnancy, this medication should be used only when||
2151|068|P|clearly needed. Discuss the risks and benefits with your doctor.||
2151|069|P|   It is unknown if this medication passes into breast milk.||
2151|070|P|Consult your doctor before breastfeeding.||
2151|071|B|||
2151|072|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2151|073|I|medications work or increase your risk for serious side effects.||
2151|074|I|This document does not contain all possible drug interactions.||
2151|075|I|Keep a list of all the products you use (including||
2151|076|I|prescription/nonprescription drugs and herbal products) and share||
2151|077|I|it with your doctor and pharmacist. Do not start, stop, or change||
2151|078|I|the dosage of any medicines without your doctor's approval.||
2151|079|B|||
2151|080|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2151|081|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2151|082|O|poison control center right away. US residents can call||
2151|083|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2151|084|B|||
2151|085|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2151|086|N|clotting time, urine protein tests) should be done before you||
2151|087|N|start using this medication and while you are using it. Keep all||
2151|088|N|medical and lab appointments. Consult your doctor for more||
2151|089|N|details.||
2151|090|B|||
2151|091|D|MISSED DOSE:  It is important to get each dose of this medication||
2151|092|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2151|093|D|right away for a new dosing schedule.||
2151|094|B|||
2151|095|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2151|096|R|doctor's office and will not be stored at home.||
2151|097|B|||
2151|098|A|Information last revised October 2024.||
2151|099|A|Copyright(c) 2025 First Databank, Inc.||
2151|100|B|||
2152|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2152|002|Z|does NOT have all possible information about this product. This||
2152|003|Z|information does not assure that this product is safe, effective,||
2152|004|Z|or appropriate for you. This information is not individual||
2152|005|Z|medical advice and does not substitute for the advice of your||
2152|006|Z|health care professional. Always ask your health care||
2152|007|Z|professional for complete information about this product and your||
2152|008|Z|specific health needs.||
2152|009|B|||
2152|010|T|VOXELOTOR - ORAL||
2152|011|F|(vox-EL-oh-tor)||
2152|012|B|||
2152|013|C|COMMON BRAND NAME(S): Oxbryta||
2152|014|B|||
2152|015|U|USES:  This medication is used to treat sickle cell disease.||
2152|016|U|People with sickle cell disease have a certain abnormal protein||
2152|017|U|(hemoglobin S) in their red blood cells that makes the cells||
2152|018|U|stiff and irregularly shaped (sickle- or crescent moon-shaped).||
2152|019|U|Voxelotor works by decreasing hemoglobin S. This effect may||
2152|020|U|decrease symptoms such as tiredness, shortness of breath, and||
2152|021|U|attacks of pain (sickle cell crisis).||
2152|022|U|   This drug has been withdrawn from the US market due to||
2152|023|U|problems with safety.||
2152|024|B|||
2152|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2152|026|H|from your pharmacist before you start taking voxelotor and each||
2152|027|H|time you get a refill. If you have any questions, ask your doctor||
2152|028|H|or pharmacist.||
2152|029|H|   Take this medication by mouth with or without food as directed||
2152|030|H|by your doctor, usually once daily. The dosage is based on your||
2152|031|H|medical condition, response to treatment, and other medications||
2152|032|H|you may be taking. Be sure to tell your doctor and pharmacist||
2152|033|H|about all the products you use (including prescription drugs,||
2152|034|H|nonprescription drugs, and herbal products).||
2152|035|H|   This medication comes in 2 different tablet forms which are||
2152|036|H|not taken the same way. Check that you receive the correct form||
2152|037|H|each time you receive your medication to avoid taking the wrong||
2152|038|H|form of this medication. Swallow the tablets whole. Do not cut,||
2152|039|H|crush, or chew the tablets.||
2152|040|H|   Use this medication regularly to get the most benefit from it.||
2152|041|H|To help you remember, take it at the same time each day.||
2152|042|H|   Tell your doctor if your symptoms do not get better or if they||
2152|043|H|get worse.||
2152|044|B|||
2152|045|S|SIDE EFFECTS:  Headache, diarrhea, nausea, stomach/abdominal||
2152|046|S|pain, or fever may occur. If any of these effects last or get||
2152|047|S|worse, tell your doctor or pharmacist promptly.||
2152|048|S|   Remember that this medication has been prescribed because your||
2152|049|S|doctor has judged that the benefit to you is greater than the||
2152|050|S|risk of side effects. Many people using this medication do not||
2152|051|S|have serious side effects.||
2152|052|S|   A very serious allergic reaction to this drug is rare.||
2152|053|S|However, get medical help right away if you notice any symptoms||
2152|054|S|of a serious allergic reaction, including: fever, swollen lymph||
2152|055|S|nodes, rash, itching/swelling (especially of the||
2152|056|S|face/tongue/throat), severe dizziness, trouble breathing.||
2152|057|S|   This is not a complete list of possible side effects. If you||
2152|058|S|notice other effects not listed above, contact your doctor or||
2152|059|S|pharmacist.||
2152|060|S|   In the US -||
2152|061|S|   Call your doctor for medical advice about side effects. You||
2152|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2152|063|S|www.fda.gov/medwatch.||
2152|064|S|   In Canada - Call your doctor for medical advice about side||
2152|065|S|effects. You may report side effects to Health Canada at||
2152|066|S|1-866-234-2345.||
2152|067|B|||
2152|068|P|PRECAUTIONS:  Before taking voxelotor, tell your doctor or||
2152|069|P|pharmacist if you are allergic to it; or if you have any other||
2152|070|P|allergies. This product may contain inactive ingredients, which||
2152|071|P|can cause allergic reactions or other problems. Talk to your||
2152|072|P|pharmacist for more details.||
2152|073|P|   Before using this medication, tell your doctor or pharmacist||
2152|074|P|your medical history, especially of: liver problems.||
2152|075|P|   Before having surgery, tell your doctor or dentist about all||
2152|076|P|the products you use (including prescription drugs,||
2152|077|P|nonprescription drugs, and herbal products).||
2152|078|P|   During pregnancy, this medication should be used only when||
2152|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
2152|080|P|   It is unknown if this medication passes into breast milk.||
2152|081|P|Because of the possible risk to the infant, breastfeeding is not||
2152|082|P|recommended while using this medication and for at least 2 weeks||
2152|083|P|after the last dose. Consult your doctor before breastfeeding.||
2152|084|B|||
2152|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2152|086|I|medications work or increase your risk for serious side effects.||
2152|087|I|This document does not contain all possible drug interactions.||
2152|088|I|Keep a list of all the products you use (including||
2152|089|I|prescription/nonprescription drugs and herbal products) and share||
2152|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
2152|091|I|the dosage of any medicines without your doctor's approval.||
2152|092|I|   A product that may interact with this drug is: elacestrant.||
2152|093|I|   Other medications can affect the removal of voxelotor from||
2152|094|I|your body, which may affect how voxelotor works. Examples include||
2152|095|I|azole antifungals (such as fluconazole, ketoconazole), efavirenz,||
2152|096|I|macrolide antibiotics (such as erythromycin), St. John's wort,||
2152|097|I|drugs used to treat seizures (such as carbamazepine, phenytoin),||
2152|098|I|among others.||
2152|099|I|   This medication may interfere with certain lab tests, possibly||
2152|100|I|causing false test results. Make sure lab personnel and all your||
2152|101|I|doctors know you use this drug.||
2152|102|B|||
2152|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2152|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2152|105|O|poison control center right away. US residents can call||
2152|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2152|107|B|||
2152|108|N|NOTES:  Do not share this medication with others.||
2152|109|N|   Lab and/or medical tests (such as blood counts) should be done||
2152|110|N|while you are taking this medication. Keep all medical and lab||
2152|111|N|appointments.||
2152|112|B|||
2152|113|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2152|114|D|remember. If it is near the time of the next dose, skip the||
2152|115|D|missed dose. Take your next dose at the regular time. Do not||
2152|116|D|double the dose to catch up.||
2152|117|B|||
2152|118|R|STORAGE:  Store at room temperature away from light and moisture.||
2152|119|R|Do not store in the bathroom. Keep all medications away from||
2152|120|R|children and pets.||
2152|121|R|   Do not flush medications down the toilet or pour them into a||
2152|122|R|drain unless instructed to do so. Properly discard this product||
2152|123|R|when it is expired or no longer needed. Consult your pharmacist||
2152|124|R|or local waste disposal company.||
2152|125|B|||
2152|126|A|Information last revised October 2024.||
2152|127|A|Copyright(c) 2025 First Databank, Inc.||
2152|128|B|||
2153|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2153|002|Z|does NOT have all possible information about this product. This||
2153|003|Z|information does not assure that this product is safe, effective,||
2153|004|Z|or appropriate for you. This information is not individual||
2153|005|Z|medical advice and does not substitute for the advice of your||
2153|006|Z|health care professional. Always ask your health care||
2153|007|Z|professional for complete information about this product and your||
2153|008|Z|specific health needs.||
2153|009|B|||
2153|010|T|GOLODIRSEN - INJECTION||
2153|011|F|(GOE-loe-DIR-sen)||
2153|012|B|||
2153|013|C|COMMON BRAND NAME(S): Vyondys 53||
2153|014|B|||
2153|015|U|USES:  Golodirsen is used to treat a certain inherited muscle||
2153|016|U|disorder (Duchenne muscular dystrophy-DMD). This disorder is||
2153|017|U|caused by a lack of a certain muscle protein (dystrophin). This||
2153|018|U|medication can increase the amount of dystrophin in your body.||
2153|019|B|||
2153|020|H|HOW TO USE:  This medication is given by injection into a vein by||
2153|021|H|a health care professional as directed by your doctor. It is||
2153|022|H|usually given once every week over 35 to 60 minutes. The dosage||
2153|023|H|is based on your weight.||
2153|024|H|   Tell your doctor if your condition does not get better or if||
2153|025|H|it gets worse.||
2153|026|B|||
2153|027|S|SIDE EFFECTS:  Pain at the injection site, headache, nausea,||
2153|028|S|vomiting, diarrhea, dizziness, abdominal pain, or cold-like||
2153|029|S|symptoms (such as runny/stuffy nose, sore throat, cough) may||
2153|030|S|occur. If any of these effects last or get worse, tell your||
2153|031|S|doctor or pharmacist promptly.||
2153|032|S|   Remember that this medication has been prescribed because your||
2153|033|S|doctor has judged that the benefit to you is greater than the||
2153|034|S|risk of side effects. Many people using this medication do not||
2153|035|S|have serious side effects.||
2153|036|S|   Tell your doctor right away if you have any serious side||
2153|037|S|effects, including: kidney problems (such as change in the amount||
2153|038|S|of urine).||
2153|039|S|   A very serious allergic reaction to this drug is rare.||
2153|040|S|However, get medical help right away if you notice any symptoms||
2153|041|S|of a serious allergic reaction, including: fever, rash,||
2153|042|S|itching/swelling (especially of the face/tongue/throat), severe||
2153|043|S|dizziness, trouble breathing.||
2153|044|S|   This is not a complete list of possible side effects. If you||
2153|045|S|notice other effects not listed above, contact your doctor or||
2153|046|S|pharmacist.||
2153|047|S|   In the US -||
2153|048|S|   Call your doctor for medical advice about side effects. You||
2153|049|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2153|050|S|www.fda.gov/medwatch.||
2153|051|S|   In Canada - Call your doctor for medical advice about side||
2153|052|S|effects. You may report side effects to Health Canada at||
2153|053|S|1-866-234-2345.||
2153|054|B|||
2153|055|P|PRECAUTIONS:  Before using golodirsen, tell your doctor or||
2153|056|P|pharmacist if you are allergic to it; or if you have any other||
2153|057|P|allergies. This product may contain inactive ingredients, which||
2153|058|P|can cause allergic reactions or other problems. Talk to your||
2153|059|P|pharmacist for more details.||
2153|060|P|   Before using this medication, tell your doctor or pharmacist||
2153|061|P|your medical history, especially of: kidney problems.||
2153|062|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2153|063|P|can make you more dizzy. Do not drive, use machinery, or do||
2153|064|P|anything that needs alertness until you can do it safely. Limit||
2153|065|P|alcoholic beverages. Talk to your doctor if you are using||
2153|066|P|marijuana (cannabis).||
2153|067|P|   Before having surgery, tell your doctor or dentist about all||
2153|068|P|the products you use (including prescription drugs,||
2153|069|P|nonprescription drugs, and herbal products).||
2153|070|P|   During pregnancy, this medication should be used only when||
2153|071|P|clearly needed. Discuss the risks and benefits with your doctor.||
2153|072|P|   It is unknown if this drug passes into breast milk. Consult||
2153|073|P|your doctor before breastfeeding.||
2153|074|B|||
2153|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2153|076|I|medications work or increase your risk for serious side effects.||
2153|077|I|This document does not contain all possible drug interactions.||
2153|078|I|Keep a list of all the products you use (including||
2153|079|I|prescription/nonprescription drugs and herbal products) and share||
2153|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
2153|081|I|the dosage of any medicines without your doctor's approval.||
2153|082|B|||
2153|083|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2153|084|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2153|085|O|poison control center right away. US residents can call||
2153|086|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2153|087|B|||
2153|088|N|NOTES:  Lab and/or medical tests (such as kidney function) should||
2153|089|N|be done before you start using this medication and while you are||
2153|090|N|using it. Keep all medical and lab appointments. Consult your||
2153|091|N|doctor for more details.||
2153|092|B|||
2153|093|D|MISSED DOSE:  It is important to get each dose of this medication||
2153|094|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2153|095|D|right away for a new dosing schedule.||
2153|096|B|||
2153|097|R|STORAGE:  Not applicable. This medication is given in a hospital||
2153|098|R|or clinic or doctor's office and will not be stored at home.||
2153|099|B|||
2153|100|A|Information last revised May 2024.||
2153|101|A|Copyright(c) 2025 First Databank, Inc.||
2153|102|B|||
2154|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2154|002|Z|does NOT have all possible information about this product. This||
2154|003|Z|information does not assure that this product is safe, effective,||
2154|004|Z|or appropriate for you. This information is not individual||
2154|005|Z|medical advice and does not substitute for the advice of your||
2154|006|Z|health care professional. Always ask your health care||
2154|007|Z|professional for complete information about this product and your||
2154|008|Z|specific health needs.||
2154|009|B|||
2154|010|T|ASENAPINE PATCH - TRANSDERMAL||
2154|011|F|(a-SEN-a-peen)||
2154|012|B|||
2154|013|C|COMMON BRAND NAME(S): Secuado||
2154|014|B|||
2154|015|W|WARNING:  There may be a slightly increased risk of serious,||
2154|016|W|possibly fatal side effects (such as stroke, heart failure,||
2154|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
2154|018|W|by older adults with dementia. This medication is not approved||
2154|019|W|for the treatment of dementia-related behavior problems. Discuss||
2154|020|W|the risks and benefits of this medication, as well as other||
2154|021|W|effective and possibly safer treatments for dementia-related||
2154|022|W|behavior problems, with the doctor.||
2154|023|W|   If you are using asenapine in combination with other||
2154|024|W|medication to treat depression, also carefully read the drug||
2154|025|W|information for the other medication.||
2154|026|B|||
2154|027|U|USES:  This medication is used to treat certain mental/mood||
2154|028|U|disorders (such as schizophrenia). Asenapine belongs to a class||
2154|029|U|of drugs known as atypical antipsychotics. It works by helping to||
2154|030|U|restore the balance of certain natural substances in the brain.||
2154|031|B|||
2154|032|H|HOW TO USE:  Read the Instructions for Use leaflet if available||
2154|033|H|from your pharmacist before you start using asenapine patch and||
2154|034|H|each time you get a refill. If you have any questions, ask your||
2154|035|H|doctor or pharmacist.||
2154|036|H|   The asenapine patch is for use only on the skin. Apply the||
2154|037|H|patch to the skin as directed by your doctor, usually once daily||
2154|038|H|(every 24 hours). Remove the old patch first before applying a||
2154|039|H|new patch. Do not wear 2 patches at the same time. To prevent||
2154|040|H|skin irritation, change where you apply a new patch each time.||
2154|041|H|When changing your patch, remove the old patch, fold it in half||
2154|042|H|with the sticky sides together, and throw it away out of reach of||
2154|043|H|children and pets.||
2154|044|H|   Do not open the sealed pouch for the new patch until you are||
2154|045|H|ready to use it. Open the pouch and remove the protective liner||
2154|046|H|from the patch as directed. Do not cut the patch. Apply the patch||
2154|047|H|as directed to a clean, dry, hairless area on the upper arm,||
2154|048|H|upper back, abdomen, or hip. Do not apply the patch on skin that||
2154|049|H|has cuts, scrapes, burns, rash, redness, or other skin problems.||
2154|050|H|Do not apply the patch on skin that has lotions, oils, or powders||
2154|051|H|on it. Avoid applying it to areas where tight clothing may rub||
2154|052|H|the patch off. Wash your hands with soap and water after applying||
2154|053|H|the patch. Do not wear the patch longer than 24 hours.||
2154|054|H|   You may shower with the patch on. However, avoid bathing or||
2154|055|H|swimming while wearing the patch, since these may cause the patch||
2154|056|H|to fall off. Avoid heat sources (such as a hair dryer, heating||
2154|057|H|pad, electric blanket, or heated water bed) at the application||
2154|058|H|site.||
2154|059|H|   Check the patch regularly during the day to make sure it is||
2154|060|H|still firmly stuck to your skin, especially after showering,||
2154|061|H|using the bathroom, changing clothes, sleeping, or sweating. If||
2154|062|H|the patch edges lift off your skin, smooth them down and press||
2154|063|H|them firmly back in place. If the patch falls off before it is||
2154|064|H|due to be changed, apply a new patch right away. Replace the new||
2154|065|H|patch at the regular time the next day. Do not try to reapply the||
2154|066|H|old patch or use tape to keep a loose patch from falling off.||
2154|067|H|   The dosage is based on your medical condition, response to||
2154|068|H|treatment, and other medications you may be taking. Be sure to||
2154|069|H|tell your doctor and pharmacist about all the products you use||
2154|070|H|(including prescription drugs, nonprescription drugs, and herbal||
2154|071|H|products). Use this medication regularly to get the most benefit||
2154|072|H|from it. To help you remember, apply it at the same time each||
2154|073|H|day.||
2154|074|H|   It is very important to keep using this medication exactly as||
2154|075|H|prescribed, even if you are feeling better and thinking more||
2154|076|H|clearly. Do not increase your dose or use this drug more often||
2154|077|H|than prescribed. Your condition will not improve any faster, and||
2154|078|H|your risk of side effects will increase. Do not stop using this||
2154|079|H|medication without consulting your doctor.||
2154|080|H|   Tell your doctor if your condition does not get better or if||
2154|081|H|it gets worse.||
2154|082|B|||
2154|083|S|SIDE EFFECTS:  Redness, itching, pain, or irritation at the||
2154|084|S|application site may occur. Drowsiness, dizziness,||
2154|085|S|lightheadedness, or weight gain may occur. If any of these||
2154|086|S|effects last or get worse, tell your doctor or pharmacist||
2154|087|S|promptly.||
2154|088|S|   Dizziness and lightheadedness can increase the risk of||
2154|089|S|falling. Get up slowly when rising from a sitting or lying||
2154|090|S|position.||
2154|091|S|   Tell your doctor right away if any of these side effects||
2154|092|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
2154|093|S|mask-like expression of the face, drooling/trouble swallowing, or||
2154|094|S|shuffling walk. Your doctor may prescribe another medication to||
2154|095|S|decrease these side effects.||
2154|096|S|   Remember that this medication has been prescribed because your||
2154|097|S|doctor has judged that the benefit to you is greater than the||
2154|098|S|risk of side effects. Many people using this medication do not||
2154|099|S|have serious side effects.||
2154|100|S|   Rarely, this medication may cause face/muscle twitching and||
2154|101|S|uncontrollable movements (tardive dyskinesia). In some cases,||
2154|102|S|this condition may be permanent. Tell your doctor right away if||
2154|103|S|you develop any uncontrollable movements such as lip smacking,||
2154|104|S|mouth puckering, tongue thrusting, chewing, or unusual arm/leg||
2154|105|S|movements.||
2154|106|S|   This drug may rarely make your blood sugar rise, which can||
2154|107|S|cause or worsen diabetes. Weight gain from this drug may increase||
2154|108|S|the risk of this side effect. Tell your doctor right away if you||
2154|109|S|have symptoms of high blood sugar, such as increased||
2154|110|S|thirst/urination. If you already have diabetes, check your blood||
2154|111|S|sugar regularly as directed and share the results with your||
2154|112|S|doctor. Your doctor may need to adjust your diabetes medication,||
2154|113|S|exercise program, or diet.||
2154|114|S|   In rare cases, asenapine may increase your level of a certain||
2154|115|S|substance made by the body (prolactin). For females, this||
2154|116|S|increase in prolactin may result in unwanted breast milk,||
2154|117|S|missed/stopped periods, or difficulty becoming pregnant. For||
2154|118|S|males, it may result in decreased sexual ability, inability to||
2154|119|S|produce sperm, or enlarged breasts. If you develop any of these||
2154|120|S|symptoms, tell your doctor right away.||
2154|121|S|   Rarely, with similar drugs, males may have a painful or||
2154|122|S|prolonged erection lasting 4 or more hours. If this occurs, stop||
2154|123|S|using this drug and get medical help right away, or permanent||
2154|124|S|problems could occur.||
2154|125|S|   Tell your doctor right away if you have any serious side||
2154|126|S|effects, including: interrupted breathing during sleep (sleep||
2154|127|S|apnea), signs of infection (such as sore throat that doesn't go||
2154|128|S|away, fever, chills).||
2154|129|S|   Get medical help right away if you have any very serious side||
2154|130|S|effects, including: severe dizziness, fainting, slow heartbeat,||
2154|131|S|seizures.||
2154|132|S|   This medication may rarely cause a very serious condition||
2154|133|S|called neuroleptic malignant syndrome (NMS). Get medical help||
2154|134|S|right away if you have any of the following symptoms: fever,||
2154|135|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
2154|136|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
2154|137|S|signs of kidney problems (such as change in the amount of urine).||
2154|138|S|   A very serious allergic reaction to this drug is rare.||
2154|139|S|However, get medical help right away if you notice any symptoms||
2154|140|S|of a serious allergic reaction, including: rash, itching/swelling||
2154|141|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2154|142|S|breathing.||
2154|143|S|   This is not a complete list of possible side effects. If you||
2154|144|S|notice other effects not listed above, contact your doctor or||
2154|145|S|pharmacist.||
2154|146|S|   In the US -||
2154|147|S|   Call your doctor for medical advice about side effects. You||
2154|148|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2154|149|S|www.fda.gov/medwatch.||
2154|150|S|   In Canada - Call your doctor for medical advice about side||
2154|151|S|effects. You may report side effects to Health Canada at||
2154|152|S|1-866-234-2345.||
2154|153|B|||
2154|154|P|PRECAUTIONS:  See also Warning section.||
2154|155|P|   Before using asenapine, tell your doctor or pharmacist if you||
2154|156|P|are allergic to it; or if you have any other allergies. This||
2154|157|P|product may contain inactive ingredients, which can cause||
2154|158|P|allergic reactions or other problems. Talk to your pharmacist for||
2154|159|P|more details.||
2154|160|P|   Before using this medication, tell your doctor or pharmacist||
2154|161|P|your medical history, especially of: liver problems, heart||
2154|162|P|problems (such as previous heart attack, angina, abnormal heart||
2154|163|P|rhythm), stroke, diabetes (including family history), low blood||
2154|164|P|pressure, seizures, blood/bleeding problems, dehydration, breast||
2154|165|P|cancer, substance use disorder (such as overuse of or addiction||
2154|166|P|to drugs/alcohol), Alzheimer's disease, dementia, trouble||
2154|167|P|swallowing, breathing trouble during sleep (sleep apnea).||
2154|168|P|   Asenapine may cause a condition that affects the heart rhythm||
2154|169|P|(QT prolongation). QT prolongation can rarely cause serious||
2154|170|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2154|171|P|as severe dizziness, fainting) that need medical attention right||
2154|172|P|away.||
2154|173|P|   The risk of QT prolongation may be increased if you have||
2154|174|P|certain medical conditions or are taking other drugs that may||
2154|175|P|cause QT prolongation. Before using asenapine, tell your doctor||
2154|176|P|or pharmacist of all the drugs you take and if you have any of||
2154|177|P|the following conditions: certain heart problems (heart failure,||
2154|178|P|slow heartbeat, QT prolongation in the EKG), family history of||
2154|179|P|certain heart problems (QT prolongation in the EKG, sudden||
2154|180|P|cardiac death).||
2154|181|P|   Low levels of potassium or magnesium in the blood may also||
2154|182|P|increase your risk of QT prolongation. This risk may increase if||
2154|183|P|you use certain drugs (such as diuretics/"water pills") or if you||
2154|184|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2154|185|P|Talk to your doctor about using asenapine safely.||
2154|186|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2154|187|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2154|188|P|machinery, or do anything that needs alertness until you can do||
2154|189|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2154|190|P|are using marijuana (cannabis).||
2154|191|P|   Before having surgery, tell your doctor or dentist about all||
2154|192|P|the products you use (including prescription drugs,||
2154|193|P|nonprescription drugs, and herbal products).||
2154|194|P|   This medication may make you sweat less, making you more||
2154|195|P|likely to get heat stroke. Avoid doing things that may cause you||
2154|196|P|to overheat, such as hard work or exercise in hot weather, or||
2154|197|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2154|198|P|and dress lightly. If you overheat, quickly look for a place to||
2154|199|P|cool down and rest. Get medical help right away if you have a||
2154|200|P|fever that does not go away, mental/mood changes, headache, or||
2154|201|P|dizziness.||
2154|202|P|   Older adults may be more sensitive to the side effects of this||
2154|203|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
2154|204|P|prolongation (see above). Drowsiness, dizziness, and||
2154|205|P|lightheadedness can increase the risk of falling.||
2154|206|P|   During pregnancy, this medication should be used only when||
2154|207|P|clearly needed. Babies born to mothers who have used this drug||
2154|208|P|during the last 3 months of pregnancy may rarely develop symptoms||
2154|209|P|including muscle stiffness or shakiness, drowsiness,||
2154|210|P|feeding/breathing difficulties, or constant crying. If you notice||
2154|211|P|any of these symptoms in your newborn especially during their||
2154|212|P|first month, tell the doctor promptly.||
2154|213|P|   Since untreated mental/mood problems (such as schizophrenia,||
2154|214|P|bipolar disorder, depression) can be a serious condition, do not||
2154|215|P|stop using this medication unless directed by your doctor. If you||
2154|216|P|are planning pregnancy, become pregnant, or think you may be||
2154|217|P|pregnant, discuss with your doctor right away about the benefits||
2154|218|P|and risks of using this medication during pregnancy.||
2154|219|P|   It is unknown if this medication passes into breast milk.||
2154|220|P|Consult your doctor before breastfeeding.||
2154|221|B|||
2154|222|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2154|223|I|medications work or increase your risk for serious side effects.||
2154|224|I|This document does not contain all possible drug interactions.||
2154|225|I|Keep a list of all the products you use (including||
2154|226|I|prescription/nonprescription drugs and herbal products) and share||
2154|227|I|it with your doctor and pharmacist. Do not start, stop, or change||
2154|228|I|the dosage of any medicines without your doctor's approval.||
2154|229|I|   Asenapine can slow down the removal of other medications from||
2154|230|I|your body, which may affect how they work. One example is||
2154|231|I|paroxetine, among others.||
2154|232|I|   Tell your doctor or pharmacist if you are taking other||
2154|233|I|products that cause drowsiness such as opioid pain or cough||
2154|234|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2154|235|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2154|236|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2154|237|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2154|238|I|diphenhydramine).||
2154|239|I|   Check the labels on all your medicines (such as allergy or||
2154|240|I|cough-and-cold products) because they may contain ingredients||
2154|241|I|that cause drowsiness. Ask your pharmacist about using those||
2154|242|I|products safely.||
2154|243|B|||
2154|244|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2154|245|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2154|246|O|poison control center right away. US residents can call||
2154|247|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2154|248|O|Symptoms of overdose may include: severe drowsiness/deep sleep,||
2154|249|O|agitation, confusion, fainting.||
2154|250|B|||
2154|251|N|NOTES:  Do not share this medication with others.||
2154|252|N|   Lab and/or medical tests (such as weight, blood sugar, blood||
2154|253|N|pressure, complete blood counts, cholesterol/triglyceride levels)||
2154|254|N|should be done while you are using this medication. Keep all||
2154|255|N|medical and lab appointments.||
2154|256|B|||
2154|257|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2154|258|D|If it is near the time of the next dose, skip the missed dose.||
2154|259|D|Use your next dose at the regular time. Do not double the dose to||
2154|260|D|catch up.||
2154|261|B|||
2154|262|R|STORAGE:  Store at room temperature. Keep all medications away||
2154|263|R|from children and pets.||
2154|264|R|   Do not flush medications down the toilet or pour them into a||
2154|265|R|drain unless instructed to do so. Properly discard this product||
2154|266|R|when it is expired or no longer needed. Consult your pharmacist||
2154|267|R|or local waste disposal company.||
2154|268|B|||
2154|269|A|Information last revised April 2025.||
2154|270|A|Copyright(c) 2025 First Databank, Inc.||
2154|271|B|||
2155|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2155|002|Z|does NOT have all possible information about this product. This||
2155|003|Z|information does not assure that this product is safe, effective,||
2155|004|Z|or appropriate for you. This information is not individual||
2155|005|Z|medical advice and does not substitute for the advice of your||
2155|006|Z|health care professional. Always ask your health care||
2155|007|Z|professional for complete information about this product and your||
2155|008|Z|specific health needs.||
2155|009|B|||
2155|010|T|ENFORTUMAB VEDOTIN - INJECTION||
2155|011|F|(en-FORT-ue-mab ve-DOE-tin)||
2155|012|B|||
2155|013|C|COMMON BRAND NAME(S): Padcev||
2155|014|B|||
2155|015|W|WARNING:  Enfortumab vedotin may rarely cause very serious||
2155|016|W|(possibly fatal) skin reactions. These skin reactions mostly||
2155|017|W|happened during the first cycle of treatment but may occur later.||
2155|018|W|Get medical help right away if you develop any itching, rash,||
2155|019|W|blisters, peeling skin, or sores on your skin, lips, or in your||
2155|020|W|mouth. Ask your doctor or pharmacist for more details.||
2155|021|B|||
2155|022|U|USES:  This medication is used to treat bladder and urinary tract||
2155|023|U|cancer. It works by slowing or stopping the growth of cancer||
2155|024|U|cells.||
2155|025|B|||
2155|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2155|027|H|from your pharmacist before you start using enfortumab vedotin||
2155|028|H|and each time you get a treatment. If you have any questions, ask||
2155|029|H|your doctor or pharmacist.||
2155|030|H|   This medication is given by slow injection into a vein by a||
2155|031|H|healthcare provider, usually over 30 minutes. Your doctor may||
2155|032|H|direct you to receive this medication on certain days in a||
2155|033|H|treatment cycle. Carefully follow your doctor's instructions.||
2155|034|H|   The dosage is based on your medical condition, weight, and||
2155|035|H|response to treatment.||
2155|036|H|   Use this medication regularly to get the most benefit from it.||
2155|037|H|To help you remember, mark your calendar with a reminder.||
2155|038|B|||
2155|039|S|SIDE EFFECTS:  See also Warning section.||
2155|040|S|   Numbness/tingling in your hands/feet, muscle weakness,||
2155|041|S|tiredness, nausea, vomiting, diarrhea, loss of appetite, change||
2155|042|S|in how food tastes, blurred vision, or dry eyes may occur. If any||
2155|043|S|of these effects last or get worse, tell your doctor or||
2155|044|S|pharmacist promptly.||
2155|045|S|   Nausea and vomiting can be severe. In some cases, your doctor||
2155|046|S|may prescribe medication to prevent or relieve nausea and||
2155|047|S|vomiting. Eating several small meals, not eating before||
2155|048|S|treatment, or limiting activity may help lessen some of these||
2155|049|S|effects.||
2155|050|S|   To prevent or treat dry eyes, your doctor may direct you to||
2155|051|S|use an eye lubricant, such as artificial tears. Ask your doctor||
2155|052|S|or pharmacist for more information.||
2155|053|S|   Temporary hair loss may occur. Normal hair growth should||
2155|054|S|return after treatment has ended.||
2155|055|S|   People using this medication may have serious side effects.||
2155|056|S|However, you have been prescribed this drug because your doctor||
2155|057|S|has judged that the benefit to you is greater than the risk of||
2155|058|S|side effects. Careful monitoring by your doctor may decrease your||
2155|059|S|risk.||
2155|060|S|   Tell your doctor right away if you have any serious side||
2155|061|S|effects, including: easy bruising/bleeding.||
2155|062|S|   This medication may rarely make your blood sugar rise, which||
2155|063|S|can cause or worsen diabetes. Tell your doctor right away if you||
2155|064|S|have symptoms of high blood sugar, such as increased||
2155|065|S|thirst/urination. If you already have diabetes, check your blood||
2155|066|S|sugar regularly as directed and share the results with your||
2155|067|S|doctor. Your doctor may need to adjust your diabetes medication,||
2155|068|S|exercise program, or diet.||
2155|069|S|   Leakage of medication around the injection site can happen||
2155|070|S|right after you receive an injection, but sometimes may happen||
2155|071|S|days after the injection. Tell your health care provider right||
2155|072|S|away if you have redness, swelling, itching, or irritation at the||
2155|073|S|injection site.||
2155|074|S|   This medication may lower your ability to fight infections.||
2155|075|S|This may make you more likely to get a serious (rarely fatal)||
2155|076|S|infection or make any infection you have worse. Tell your doctor||
2155|077|S|right away if you have any signs of infection (such as sore||
2155|078|S|throat that doesn't go away, fever, chills).||
2155|079|S|   Get medical help right away if you have any very serious side||
2155|080|S|effects, including: cough that doesn't go away, chest pain,||
2155|081|S|shortness of breath.||
2155|082|S|   A very serious allergic reaction to this drug is rare.||
2155|083|S|However, get medical help right away if you notice any symptoms||
2155|084|S|of a serious allergic reaction, including: rash, itching/swelling||
2155|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2155|086|S|breathing.||
2155|087|S|   This is not a complete list of possible side effects. If you||
2155|088|S|notice other effects not listed above, contact your doctor or||
2155|089|S|pharmacist.||
2155|090|S|   In the US -||
2155|091|S|   Call your doctor for medical advice about side effects. You||
2155|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2155|093|S|www.fda.gov/medwatch.||
2155|094|S|   In Canada - Call your doctor for medical advice about side||
2155|095|S|effects. You may report side effects to Health Canada at||
2155|096|S|1-866-234-2345.||
2155|097|B|||
2155|098|P|PRECAUTIONS:  Before receiving enfortumab vedotin, tell your||
2155|099|P|doctor or pharmacist if you are allergic to it; or if you have||
2155|100|P|any other allergies. This product may contain inactive||
2155|101|P|ingredients, which can cause allergic reactions or other||
2155|102|P|problems. Talk to your pharmacist for more details.||
2155|103|P|   Before using this medication, tell your doctor or pharmacist||
2155|104|P|your medical history, especially of: diabetes, nerve problems||
2155|105|P|(such as numbness/tingling), liver disease.||
2155|106|P|   Enfortumab vedotin can make you more likely to get infections||
2155|107|P|or may make current infections worse. Stay away from anyone who||
2155|108|P|has an infection that may easily spread (such as chickenpox,||
2155|109|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2155|110|P|exposed to an infection or for more details.||
2155|111|P|   Tell your health care professional that you are using||
2155|112|P|enfortumab vedotin before having any immunizations/vaccinations.||
2155|113|P|Avoid contact with people who have recently received live||
2155|114|P|vaccines (such as flu vaccine inhaled through the nose).||
2155|115|P|   To lower the chance of getting cut, bruised, or injured, use||
2155|116|P|caution with sharp objects like razors and nail cutters, and||
2155|117|P|avoid activities such as contact sports.||
2155|118|P|   This drug may cause blurred vision. Do not drive, use||
2155|119|P|machinery, or do anything that needs alertness or clear vision||
2155|120|P|until you can do it safely. Limit alcoholic beverages. Talk to||
2155|121|P|your doctor if you are using marijuana (cannabis).||
2155|122|P|   Before having surgery, tell your doctor or dentist about all||
2155|123|P|the products you use (including prescription drugs,||
2155|124|P|nonprescription drugs, and herbal products).||
2155|125|P|   Tell your doctor if you are pregnant or plan to become||
2155|126|P|pregnant. You should not become pregnant while using enfortumab||
2155|127|P|vedotin. Enfortumab vedotin may harm an unborn baby. Your doctor||
2155|128|P|should order a pregnancy test before you start this medication.||
2155|129|P|Women using this medication should ask about reliable forms of||
2155|130|P|birth control during treatment and for at least 2 months after||
2155|131|P|the last dose. Men using this medication should ask about||
2155|132|P|reliable forms of birth control during treatment and for at least||
2155|133|P|4 months after the last dose. If you or your partner becomes||
2155|134|P|pregnant, talk to your doctor right away about the risks and||
2155|135|P|benefits of this medication.||
2155|136|P|   It is unknown if this drug passes into breast milk. Because of||
2155|137|P|the possible risk to the infant, breastfeeding is not recommended||
2155|138|P|while using this drug and for at least 3 weeks after the last||
2155|139|P|dose. Consult your doctor before breastfeeding.||
2155|140|B|||
2155|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2155|142|I|medications work or increase your risk for serious side effects.||
2155|143|I|This document does not contain all possible drug interactions.||
2155|144|I|Keep a list of all the products you use (including||
2155|145|I|prescription/nonprescription drugs and herbal products) and share||
2155|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
2155|147|I|the dosage of any medicines without your doctor's approval.||
2155|148|B|||
2155|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2155|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2155|151|O|poison control center right away. US residents can call||
2155|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2155|153|B|||
2155|154|N|NOTES:  Lab and/or medical tests (such as blood sugar, complete||
2155|155|N|blood counts, eye exams) may be done while you are using this||
2155|156|N|medication. Keep all medical and lab appointments.||
2155|157|B|||
2155|158|D|MISSED DOSE:  It is important to get each dose of this medication||
2155|159|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2155|160|D|right away for a new dosing schedule.||
2155|161|B|||
2155|162|R|STORAGE:  Not applicable. This medication is given in a hospital||
2155|163|R|or clinic or doctor's office and will not be stored at home.||
2155|164|B|||
2155|165|M|MEDICAL ALERT:  Your condition can cause complications in a||
2155|166|M|medical emergency. For information about enrolling in MedicAlert,||
2155|167|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2155|168|B|||
2155|169|A|Information last revised April 2025.||
2155|170|A|Copyright(c) 2025 First Databank, Inc.||
2155|171|B|||
2156|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2156|002|Z|does NOT have all possible information about this product. This||
2156|003|Z|information does not assure that this product is safe, effective,||
2156|004|Z|or appropriate for you. This information is not individual||
2156|005|Z|medical advice and does not substitute for the advice of your||
2156|006|Z|health care professional. Always ask your health care||
2156|007|Z|professional for complete information about this product and your||
2156|008|Z|specific health needs.||
2156|009|B|||
2156|010|T|STANNOUS FLUORIDE 0.63% ORAL CARE RINSE - DENTAL||
2156|011|F|(STAN-us FLOOR-ide)||
2156|012|B|||
2156|013|C|COMMON BRAND NAME(S): Gel-Kam||
2156|014|B|||
2156|015|U|USES:  This medication is applied to teeth to prevent cavities.||
2156|016|U|Fluoride is a mineral that works by making the teeth stronger and||
2156|017|U|more resistant to decay caused by acid and bacteria.||
2156|018|U|   Do not use this medication in children younger than 6 years||
2156|019|U|unless directed to do so by your dentist/doctor.||
2156|020|B|||
2156|021|H|HOW TO USE:  Read and follow all directions on the product||
2156|022|H|package before taking this medication. If you have any questions,||
2156|023|H|consult your pharmacist. Use this rinse once daily or as directed||
2156|024|H|by your dentist/doctor.||
2156|025|H|   Mix the solution with water as directed just before using.||
2156|026|H|Follow the instructions on your product's package. Using the||
2156|027|H|provided cup, take 1/8 fluid ounce (3.75 milliliters) of the||
2156|028|H|dental rinse and add water to make a total of 1 ounce (30||
2156|029|H|milliliters) of liquid.||
2156|030|H|   After brushing and flossing, place solution into your mouth,||
2156|031|H|swish vigorously for 1 minute, then spit it out. Do not swallow.||
2156|032|H|   Carefully watch children during use and teach proper rinsing||
2156|033|H|habits to avoid swallowing.||
2156|034|H|   If you are using a home irrigator, prepare 1 ounce of solution||
2156|035|H|as described above. Pour into irrigator reservoir and add 4 more||
2156|036|H|ounces (120 milliliters) of water. Mix thoroughly. Use irrigator||
2156|037|H|as directed. Rinse the irrigator with water after each use.||
2156|038|H|   To get the most benefit, do not eat, drink, or rinse your||
2156|039|H|mouth for at least 30 minutes after using the solution.||
2156|040|H|   Dosage is based on age and the amount of fluoride in your||
2156|041|H|drinking water. Do not exceed the recommended dose without||
2156|042|H|checking with your dentist/doctor. Doing so will not do more to||
2156|043|H|prevent cavities but may lead to side effects instead.||
2156|044|H|   Use this medication regularly to get the most benefit from it.||
2156|045|H|To help you remember, use it at the same time each day.||
2156|046|H|   Do not treat this medication like a normal mouthwash: do not||
2156|047|H|use it more often than prescribed, or just to freshen your||
2156|048|H|breath.||
2156|049|B|||
2156|050|S|SIDE EFFECTS:  Temporary staining of the teeth may occur.||
2156|051|S|Brushing may control these stains, which can be removed by your||
2156|052|S|dental professional. If this effect lasts or gets worse, tell||
2156|053|S|your dentist or doctor promptly.||
2156|054|S|   Tell your dentist/doctor right away if you notice any changes||
2156|055|S|in the color or appearance of your teeth. These effects may be a||
2156|056|S|result of too much fluoride.||
2156|057|S|   If your dentist/doctor has directed you to use this||
2156|058|S|medication, remember that your dentist/doctor has judged that the||
2156|059|S|benefit to you is greater than the risk of side effects. Many||
2156|060|S|people using this medication do not have serious side effects.||
2156|061|S|   A very serious allergic reaction to this drug is rare.||
2156|062|S|However, get medical help right away if you notice any symptoms||
2156|063|S|of a serious allergic reaction, including: rash, itching/swelling||
2156|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2156|065|S|breathing.||
2156|066|S|   This is not a complete list of possible side effects. If you||
2156|067|S|notice other effects not listed above, contact your||
2156|068|S|dentist/doctor or pharmacist.||
2156|069|S|   In the US -||
2156|070|S|   Call your doctor for medical advice about side effects. You||
2156|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2156|072|S|www.fda.gov/medwatch.||
2156|073|S|   In Canada - Call your doctor for medical advice about side||
2156|074|S|effects. You may report side effects to Health Canada at||
2156|075|S|1-866-234-2345.||
2156|076|B|||
2156|077|P|PRECAUTIONS:  Before using stannous fluoride, tell your doctor or||
2156|078|P|pharmacist if you are allergic to it; or if you have any other||
2156|079|P|allergies. This product may contain inactive ingredients, which||
2156|080|P|can cause allergic reactions or other problems. Talk to your||
2156|081|P|pharmacist for more details.||
2156|082|P|   Before using this medication, tell your doctor or pharmacist||
2156|083|P|your medical history, especially of: swallowing problems||
2156|084|P|(dysphagia).||
2156|085|P|   Children may be more sensitive to the side effects of this||
2156|086|P|drug, especially if this medication is swallowed.||
2156|087|P|   Tell your doctor if you are pregnant before using this||
2156|088|P|medication.||
2156|089|P|   This medication passes into breast milk. Consult your doctor||
2156|090|P|before breastfeeding.||
2156|091|B|||
2156|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2156|093|I|medications work or increase your risk for serious side effects.||
2156|094|I|This document does not contain all possible drug interactions.||
2156|095|I|Keep a list of all the products you use (including||
2156|096|I|prescription/nonprescription drugs and herbal products) and share||
2156|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
2156|098|I|the dosage of any medicines without your doctor's approval.||
2156|099|B|||
2156|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2156|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2156|102|O|poison control center right away. US residents can call||
2156|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2156|104|O|Symptoms of overdose may include: burning in the mouth, sore||
2156|105|O|tongue, nausea, vomiting, diarrhea, increased saliva, stomach||
2156|106|O|pain/cramping, muscle weakness, shaking, seizures.||
2156|107|B|||
2156|108|N|NOTES:  Do not share this medication with others.||
2156|109|N|   Using this medication does not replace good dental habits.||
2156|110|N|Continue to brush and floss your teeth regularly as directed by||
2156|111|N|your dentist, and have regular dental checkups.||
2156|112|B|||
2156|113|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2156|114|D|If it is near the time of the next dose, skip the missed dose.||
2156|115|D|Use your next dose at the regular time. Do not double the dose to||
2156|116|D|catch up.||
2156|117|B|||
2156|118|R|STORAGE:  Store at room temperature. Keep all medications away||
2156|119|R|from children and pets.||
2156|120|R|   Do not flush medications down the toilet or pour them into a||
2156|121|R|drain unless instructed to do so. Properly discard this product||
2156|122|R|when it is expired or no longer needed. Consult your pharmacist||
2156|123|R|or local waste disposal company.||
2156|124|B|||
2156|125|A|Information last revised May 2024.||
2156|126|A|Copyright(c) 2025 First Databank, Inc.||
2156|127|B|||
2158|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2158|002|Z|does NOT have all possible information about this product. This||
2158|003|Z|information does not assure that this product is safe, effective,||
2158|004|Z|or appropriate for you. This information is not individual||
2158|005|Z|medical advice and does not substitute for the advice of your||
2158|006|Z|health care professional. Always ask your health care||
2158|007|Z|professional for complete information about this product and your||
2158|008|Z|specific health needs.||
2158|009|B|||
2158|010|T|OMEPRAZOLE/AMOXICILLIN/RIFABUTIN - ORAL||
2158|011|F|(oh-MEP-ra-zole/a-MOX-i-SIL-in/RIF-a-BUE-tin)||
2158|012|B|||
2158|013|C|COMMON BRAND NAME(S): Talicia||
2158|014|B|||
2158|015|U|USES:  This product is used to treat H. pylori infection in the||
2158|016|U|stomach. H. pylori can cause stomach problems such as ulcers.||
2158|017|U|   Omeprazole is known as a proton pump inhibitor (PPI). It works||
2158|018|U|by blocking acid production in the stomach. Decreasing excess||
2158|019|U|stomach acid can help treat stomach problems and allow ulcers to||
2158|020|U|heal. Amoxicillin and rifabutin are antibiotics used to treat a||
2158|021|U|wide variety of bacterial infections (including H. pylori).||
2158|022|U|Treating the infection helps to reduce the risk of stomach||
2158|023|U|problems (such as ulcers). Amoxicillin is a penicillin-type||
2158|024|U|antibiotic and rifabutin is a rifamycin antibiotic. They work by||
2158|025|U|stopping the growth of bacteria.||
2158|026|U|   The antibiotics in this product treat only bacterial||
2158|027|U|infections. Antibiotics do not work for viral infections (such as||
2158|028|U|common cold, flu). Using any antibiotic when it is not needed can||
2158|029|U|cause it to not work for future infections.||
2158|030|B|||
2158|031|H|HOW TO USE:  Take this medication by mouth with food as directed||
2158|032|H|by your doctor, usually 3 times a day (at least 4 hours apart).||
2158|033|H|Swallow the capsules whole with a full glass of water (8 ounces||
2158|034|H|or 240 milliliters). Do not crush or chew the capsules or take||
2158|035|H|with alcohol.||
2158|036|H|   For the best effect, take this product at evenly spaced times.||
2158|037|H|To help you remember, take this product at the same times every||
2158|038|H|day. Continue to take this medication until the full prescribed||
2158|039|H|amount is finished, even if symptoms disappear after a few days.||
2158|040|H|Stopping the medication too early may result in a return of the||
2158|041|H|infection.||
2158|042|H|   Tell your doctor if your condition lasts or gets worse.||
2158|043|B|||
2158|044|S|SIDE EFFECTS:  Diarrhea, headache, nausea, vomiting, and changes||
2158|045|S|in your sense of taste may occur. If any of these effects last or||
2158|046|S|get worse, tell your doctor or pharmacist promptly.||
2158|047|S|   This medication may cause urine, sweat, saliva, or tears to||
2158|048|S|turn brown-orange. This effect is harmless and will disappear||
2158|049|S|when the medication is stopped. However, dentures and contact||
2158|050|S|lenses may be permanently stained.||
2158|051|S|   Remember that this medication has been prescribed because your||
2158|052|S|doctor has judged that the benefit to you is greater than the||
2158|053|S|risk of side effects. Many people using this medication do not||
2158|054|S|have serious side effects.||
2158|055|S|   Tell your doctor right away if you have any serious side||
2158|056|S|effects, including: muscle weakness/pain, signs of liver disease||
2158|057|S|(such as nausea/vomiting that doesn't stop, yellowing eyes/skin,||
2158|058|S|dark urine), easy bruising/bleeding, eye pain/redness, vision||
2158|059|S|problems, signs of lupus (such as rash on nose and cheeks, new or||
2158|060|S|worsening joint pain), signs of kidney problems (such as change||
2158|061|S|in the amount of urine, pink/bloody urine).||
2158|062|S|   This medication may rarely cause a severe intestinal condition||
2158|063|S|due to a bacteria called C. difficile. This condition may occur||
2158|064|S|during treatment or weeks to months after treatment has stopped.||
2158|065|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2158|066|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2158|067|S|stool.||
2158|068|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2158|069|S|products because they may make symptoms worse.||
2158|070|S|   A very serious allergic reaction to this drug is rare.||
2158|071|S|However, get medical help right away if you notice any symptoms||
2158|072|S|of a serious allergic reaction, including: fever, swollen lymph||
2158|073|S|nodes, rash, itching/swelling (especially of the||
2158|074|S|face/tongue/throat), severe dizziness, trouble breathing.||
2158|075|S|   Amoxicillin can commonly cause a mild rash that is usually not||
2158|076|S|serious. However, you may not be able to tell it apart from a||
2158|077|S|rare rash that could be a sign of a severe allergic reaction. Get||
2158|078|S|medical help right away if you develop any rash.||
2158|079|S|   This is not a complete list of possible side effects. If you||
2158|080|S|notice other effects not listed above, contact your doctor or||
2158|081|S|pharmacist.||
2158|082|S|   In the US -||
2158|083|S|   Call your doctor for medical advice about side effects. You||
2158|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2158|085|S|www.fda.gov/medwatch.||
2158|086|S|   In Canada - Call your doctor for medical advice about side||
2158|087|S|effects. You may report side effects to Health Canada at||
2158|088|S|1-866-234-2345.||
2158|089|B|||
2158|090|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2158|091|P|pharmacist if you are allergic to omeprazole, amoxicillin, or||
2158|092|P|rifabutin; or to penicillins (such as ampicillin), cephalosporins||
2158|093|P|(such as cephalexin), rifamycin antibiotics (such as rifampin),||
2158|094|P|or to proton pump inhibitors (such as esomeprazole); or if you||
2158|095|P|have any other allergies. This product may contain inactive||
2158|096|P|ingredients, which can cause allergic reactions or other||
2158|097|P|problems. Talk to your pharmacist for more details.||
2158|098|P|   Before using this medication, tell your doctor or pharmacist||
2158|099|P|your medical history, especially of: liver disease, kidney||
2158|100|P|disease, a certain blood disorder (porphyria), a certain type of||
2158|101|P|viral infection (mononucleosis), lupus.||
2158|102|P|   Some symptoms may actually be signs of a more serious||
2158|103|P|condition. Get medical help right away if you have: heartburn||
2158|104|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
2158|105|P|pain (especially with shortness of breath, unusual sweating),||
2158|106|P|unexplained weight loss.||
2158|107|P|   Before having surgery, tell your doctor or dentist about all||
2158|108|P|the products you use (including prescription drugs,||
2158|109|P|nonprescription drugs, and herbal products).||
2158|110|P|   This medication may cause live bacterial vaccines (such as||
2158|111|P|typhoid vaccine) to not work well. Tell your health care||
2158|112|P|professional that you are using this medication before having any||
2158|113|P|immunizations/vaccinations.||
2158|114|P|   Older adults may be more sensitive to the side effects of this||
2158|115|P|drug, especially C. difficile infection (see Side Effects||
2158|116|P|section).||
2158|117|P|   During pregnancy, this product should be used only when||
2158|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
2158|119|P|   Amoxicillin and omeprazole pass into breast milk. It is||
2158|120|P|unknown if rifabutin passes into breast milk. Consult your doctor||
2158|121|P|before breastfeeding.||
2158|122|B|||
2158|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2158|124|I|medications work or increase your risk for serious side effects.||
2158|125|I|This document does not contain all possible drug interactions.||
2158|126|I|Keep a list of all the products you use (including||
2158|127|I|prescription/nonprescription drugs and herbal products) and share||
2158|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
2158|129|I|the dosage of any medicines without your doctor's approval.||
2158|130|I|   Some products that may interact with this drug are: azole||
2158|131|I|antifungals (itraconazole, ketoconazole, posaconazole,||
2158|132|I|voriconazole), clopidogrel, methotrexate (especially high-dose||
2158|133|I|treatment), voriconazole.||
2158|134|I|   Rifabutin can speed up the removal of other medications from||
2158|135|I|your body, which may affect how they work. Examples of affected||
2158|136|I|drugs include artemether/lumefantrine, lurasidone, mavacamten,||
2158|137|I|phenytoin, ranolazine, suvorexant, calcium channel blockers (such||
2158|138|I|as diltiazem, nifedipine, verapamil), among others.||
2158|139|I|   Other medications can affect the removal of omeprazole from||
2158|140|I|your body, which may affect how omeprazole works. Examples||
2158|141|I|include rifampin, St. John's wort, among others.||
2158|142|I|   Some products need stomach acid so that the body can absorb||
2158|143|I|them properly. Omeprazole decreases stomach acid, so it may||
2158|144|I|change how well these products work. Some affected products||
2158|145|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
2158|146|I|pazopanib, rilpivirine, sparsentan, among others.||
2158|147|I|   This medication may decrease the effectiveness of hormonal||
2158|148|I|birth control such as pills, patch, or ring. This could cause||
2158|149|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2158|150|I|use reliable backup birth control methods while using this||
2158|151|I|medication. Also tell your doctor if you have any new spotting or||
2158|152|I|breakthrough bleeding, because these may be signs that your birth||
2158|153|I|control is not working well.||
2158|154|I|   Omeprazole is very similar to esomeprazole. Do not use any||
2158|155|I|medications containing esomeprazole while using omeprazole.||
2158|156|I|   This medication may interfere with certain lab tests||
2158|157|I|(including urine glucose test), possibly causing false test||
2158|158|I|results. Make sure lab personnel and all your doctors know you||
2158|159|I|use this drug.||
2158|160|B|||
2158|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2158|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2158|163|O|poison control center right away. US residents can call||
2158|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2158|165|O|Symptoms of overdose may include: confusion, blurred vision, fast||
2158|166|O|heartbeat, change in the amount of urine.||
2158|167|B|||
2158|168|N|NOTES:  Do not share this medication with others.||
2158|169|N|   This medication has been prescribed for your current condition||
2158|170|N|only. Do not use it later for another infection unless your||
2158|171|N|doctor tells you to.||
2158|172|N|   Lab and/or medical tests may be done while you are taking this||
2158|173|N|medication. Keep all medical and lab appointments. Consult your||
2158|174|N|doctor for more details.||
2158|175|B|||
2158|176|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2158|177|D|remember. Wait at least 4 hours between each dose. Do not double||
2158|178|D|the dose to catch up.||
2158|179|B|||
2158|180|R|STORAGE:  Store in the original container at room temperature||
2158|181|R|away from light and moisture. Do not store in the bathroom. Keep||
2158|182|R|all medications away from children and pets.||
2158|183|R|   Do not flush medications down the toilet or pour them into a||
2158|184|R|drain unless instructed to do so. Properly discard this product||
2158|185|R|when it is expired or no longer needed. Consult your pharmacist||
2158|186|R|or local waste disposal company.||
2158|187|B|||
2158|188|A|Information last revised March 2025.||
2158|189|A|Copyright(c) 2025 First Databank, Inc.||
2158|190|B|||
2159|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2159|002|Z|does NOT have all possible information about this product. This||
2159|003|Z|information does not assure that this product is safe, effective,||
2159|004|Z|or appropriate for you. This information is not individual||
2159|005|Z|medical advice and does not substitute for the advice of your||
2159|006|Z|health care professional. Always ask your health care||
2159|007|Z|professional for complete information about this product and your||
2159|008|Z|specific health needs.||
2159|009|B|||
2159|010|T|TRASTUZUMAB DERUXTECAN - INJECTION||
2159|011|F|(tras-TOOZ-ue-mab DER-ux-TEE-kan)||
2159|012|B|||
2159|013|C|COMMON BRAND NAME(S): Enhertu||
2159|014|B|||
2159|015|W|WARNING:  This medication may sometimes cause serious lung||
2159|016|W|problems. Tell your doctor right away if you have any new or||
2159|017|W|worsening signs of lung problems (such as cough, fever, wheezing,||
2159|018|W|shortness of breath).||
2159|019|W|   Trastuzumab deruxtecan may cause serious (possibly fatal) harm||
2159|020|W|to an unborn baby if used during pregnancy. Discuss reliable||
2159|021|W|forms of birth control with your doctor. See also Precautions||
2159|022|W|section.||
2159|023|B|||
2159|024|U|USES:  Trastuzumab deruxtecan is used to treat certain types of||
2159|025|U|cancer (such as breast cancer, lung cancer, stomach cancer,||
2159|026|U|esophageal cancer, certain other solid tumors). This medication||
2159|027|U|is called a monoclonal antibody and topoisomerase inhibitor||
2159|028|U|conjugate. Trastuzumab deruxtecan works by slowing or stopping||
2159|029|U|the growth of cancer cells.||
2159|030|B|||
2159|031|H|HOW TO USE:  Read the Medication Guide provided by your||
2159|032|H|pharmacist before you start using trastuzumab deruxtecan and each||
2159|033|H|time you get a refill. If you have any questions, ask your doctor||
2159|034|H|or pharmacist.||
2159|035|H|   This medication is given by slow injection into a vein by a||
2159|036|H|health care professional. It is given as directed by your doctor,||
2159|037|H|usually once every 3 weeks. Your first infusion will be given||
2159|038|H|over at least 90 minutes.||
2159|039|H|   The dosage, the speed of your injection, and the length of||
2159|040|H|time you receive trastuzumab deruxtecan are based on your body||
2159|041|H|weight, medical condition, and response to treatment.||
2159|042|H|   To get the most benefit from this medication, do not miss any||
2159|043|H|doses. To help you remember, mark your calendar with a reminder.||
2159|044|B|||
2159|045|S|SIDE EFFECTS:  See also Warning section.||
2159|046|S|   Diarrhea, dizziness, stomach/abdominal pain, constipation,||
2159|047|S|nausea, vomiting, mouth sores, dry mouth, loss of appetite,||
2159|048|S|tiredness, hair loss, nose bleeds, or headache may occur. Nausea||
2159|049|S|and vomiting can be severe. In some cases, your doctor may||
2159|050|S|prescribe medication to prevent or relieve nausea and vomiting.||
2159|051|S|Eating several small meals, not eating before treatment, or||
2159|052|S|limiting activity may help lessen some of these effects. If any||
2159|053|S|of these effects last or get worse, tell your doctor or||
2159|054|S|pharmacist promptly.||
2159|055|S|   Remember that this medication has been prescribed because your||
2159|056|S|doctor has judged that the benefit to you is greater than the||
2159|057|S|risk of side effects. Many people using this medication do not||
2159|058|S|have serious side effects.||
2159|059|S|   Tell your doctor right away if you have any serious side||
2159|060|S|effects, including: unusual tiredness, pale skin, easy||
2159|061|S|bruising/bleeding.||
2159|062|S|   Trastuzumab deruxtecan may lead to serious heart problems,||
2159|063|S|including heart failure. Past use of certain other anti-cancer||
2159|064|S|drugs (including anthracyclines such as doxorubicin) may increase||
2159|065|S|your risk of heart problems. Tell your doctor right away if you||
2159|066|S|have any symptoms of heart failure, including shortness of||
2159|067|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
2159|068|S|weight gain.||
2159|069|S|   This medication may lower your ability to fight infections.||
2159|070|S|This may make you more likely to get a serious (rarely fatal)||
2159|071|S|infection or make any infection you have worse. Tell your doctor||
2159|072|S|right away if you have any signs of infection (such as sore||
2159|073|S|throat that doesn't go away, fever, chills).||
2159|074|S|   A very serious allergic reaction to this drug is rare.||
2159|075|S|However, get medical help right away if you notice any symptoms||
2159|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2159|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2159|078|S|breathing.||
2159|079|S|   This is not a complete list of possible side effects. If you||
2159|080|S|notice other effects not listed above, contact your doctor or||
2159|081|S|pharmacist.||
2159|082|S|   In the US -||
2159|083|S|   Call your doctor for medical advice about side effects. You||
2159|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2159|085|S|www.fda.gov/medwatch.||
2159|086|S|   In Canada - Call your doctor for medical advice about side||
2159|087|S|effects. You may report side effects to Health Canada at||
2159|088|S|1-866-234-2345.||
2159|089|B|||
2159|090|P|PRECAUTIONS:  See also Warning section.||
2159|091|P|   Before using trastuzumab deruxtecan, tell your doctor or||
2159|092|P|pharmacist if you are allergic to it; or to any trastuzumab||
2159|093|P|emtansine, trastuzumab, or trastuzumab-hyaluronidase products; or||
2159|094|P|if you have any other allergies. This product may contain||
2159|095|P|inactive ingredients which can cause allergic reactions or other||
2159|096|P|problems. Talk to your pharmacist for more details.||
2159|097|P|   Before using this medication, tell your doctor or pharmacist||
2159|098|P|your medical history, especially of: current infection, heart||
2159|099|P|disease, lung problems.||
2159|100|P|   Trastuzumab deruxtecan can make you more likely to get||
2159|101|P|infections or may make current infections worse. Stay away from||
2159|102|P|anyone who has an infection that may easily spread (such as||
2159|103|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
2159|104|P|have been exposed to an infection or for more details.||
2159|105|P|   Tell your health care professional that you are using||
2159|106|P|trastuzumab deruxtecan before having any||
2159|107|P|immunizations/vaccinations. Avoid contact with people who have||
2159|108|P|recently received live vaccines (such as flu vaccine inhaled||
2159|109|P|through the nose).||
2159|110|P|   To lower the chance of getting cut, bruised, or injured, use||
2159|111|P|caution with sharp objects like razors and nail cutters, and||
2159|112|P|avoid activities such as contact sports.||
2159|113|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2159|114|P|can make you more dizzy. Do not drive, use machinery, or do||
2159|115|P|anything that needs alertness until you can do it safely. Limit||
2159|116|P|alcoholic beverages. Talk to your doctor if you are using||
2159|117|P|marijuana (cannabis).||
2159|118|P|   Before having surgery, tell your doctor or dentist about all||
2159|119|P|the products you use (including prescription drugs,||
2159|120|P|nonprescription drugs, and herbal products).||
2159|121|P|   Tell your doctor if you are pregnant or plan to become||
2159|122|P|pregnant. You should not become pregnant while using trastuzumab||
2159|123|P|deruxtecan. Trastuzumab deruxtecan may harm an unborn baby. Your||
2159|124|P|doctor should order a pregnancy test before you start this||
2159|125|P|medication. Women using this medication should ask about reliable||
2159|126|P|forms of birth control during treatment and for 7 months after||
2159|127|P|the last dose. Men using this medication should ask about||
2159|128|P|reliable forms of birth control during treatment and for 4 months||
2159|129|P|after the last dose. If you or your partner becomes pregnant,||
2159|130|P|talk to your doctor right away about the risks and benefits of||
2159|131|P|this medication.||
2159|132|P|   It is unknown if this drug passes into breast milk. Because of||
2159|133|P|the possible risk to the infant, breastfeeding is not recommended||
2159|134|P|while using this drug and for 7 months after the last dose.||
2159|135|P|Consult your doctor before breastfeeding.||
2159|136|B|||
2159|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2159|138|I|medications work or increase your risk for serious side effects.||
2159|139|I|This document does not contain all possible drug interactions.||
2159|140|I|Keep a list of all the products you use (including||
2159|141|I|prescription/nonprescription drugs and herbal products) and share||
2159|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
2159|143|I|the dosage of any medicines without your doctor's approval.||
2159|144|I|   If you will be using an anthracycline (such as doxorubicin)||
2159|145|I|after stopping trastuzumab deruxtecan, if possible, wait at least||
2159|146|I|7 months.||
2159|147|I|   Trastuzumab deruxtecan is very similar to trastuzumab,||
2159|148|I|trastuzumab emtansine, and trastuzumab-hyaluronidase. Do not use||
2159|149|I|a trastuzumab, trastuzumab emtansine, or||
2159|150|I|trastuzumab-hyaluronidase product while using trastuzumab||
2159|151|I|deruxtecan.||
2159|152|B|||
2159|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2159|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2159|155|O|poison control center right away. US residents can call||
2159|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2159|157|B|||
2159|158|N|NOTES:  Lab and/or medical tests (such as heart exams, complete||
2159|159|N|blood counts, liver function) should be done before you start||
2159|160|N|using this medication and while you are using it. Keep all||
2159|161|N|medical and lab appointments. Consult your doctor for more||
2159|162|N|details.||
2159|163|B|||
2159|164|D|MISSED DOSE:  It is important to get each dose of this medication||
2159|165|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2159|166|D|right away for a new dosing schedule.||
2159|167|B|||
2159|168|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2159|169|R|hospital and will not be stored at home.||
2159|170|B|||
2159|171|M|MEDICAL ALERT:  Your condition can cause complications in a||
2159|172|M|medical emergency. For information about enrolling in MedicAlert,||
2159|173|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2159|174|B|||
2159|175|A|Information last revised April 2025.||
2159|176|A|Copyright(c) 2025 First Databank, Inc.||
2159|177|B|||
2160|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2160|002|Z|does NOT have all possible information about this product. This||
2160|003|Z|information does not assure that this product is safe, effective,||
2160|004|Z|or appropriate for you. This information is not individual||
2160|005|Z|medical advice and does not substitute for the advice of your||
2160|006|Z|health care professional. Always ask your health care||
2160|007|Z|professional for complete information about this product and your||
2160|008|Z|specific health needs.||
2160|009|B|||
2160|010|T|AMLODIPINE/CELECOXIB - ORAL||
2160|011|F|(am-LOE-di-peen/SEL-e-KOX-ib)||
2160|012|B|||
2160|013|C|COMMON BRAND NAME(S): Consensi||
2160|014|B|||
2160|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
2160|016|W|celecoxib) may rarely increase the risk for a heart attack or||
2160|017|W|stroke. This effect can happen at any time while taking this drug||
2160|018|W|but is more likely if you take it for a long time. The risk may||
2160|019|W|be greater in older adults or if you have heart disease or||
2160|020|W|increased risk for heart disease (for example, due to smoking,||
2160|021|W|family history of heart disease, or conditions such as high blood||
2160|022|W|pressure or diabetes). Do not take this drug right before or||
2160|023|W|after heart bypass surgery (CABG).||
2160|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
2160|025|W|bleeding from the stomach or intestines. This effect can occur||
2160|026|W|without warning symptoms at any time while taking this drug.||
2160|027|W|Older adults may be at higher risk for this effect.||
2160|028|W|   Stop taking amlodipine/celecoxib and get medical help right||
2160|029|W|away if you notice any of these rare but serious side effects:||
2160|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
2160|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
2160|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
2160|033|W|side of the body, trouble speaking, sudden vision changes.||
2160|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
2160|035|W|of taking this drug.||
2160|036|B|||
2160|037|U|USES:  This product contains 2 medications: amlodipine and||
2160|038|U|celecoxib. This combination medication is used to treat people||
2160|039|U|who have both high blood pressure and arthritis. Amlodipine||
2160|040|U|belongs to a class of drugs known as calcium channel blockers. It||
2160|041|U|works by relaxing blood vessels so blood can flow more easily.||
2160|042|U|Lowering high blood pressure helps prevent strokes, heart||
2160|043|U|attacks, and kidney problems. Celecoxib is a nonsteroidal||
2160|044|U|anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor.||
2160|045|U|It is used to reduce pain, swelling, and joint stiffness from||
2160|046|U|arthritis.||
2160|047|B|||
2160|048|H|HOW TO USE:  Read the Medication Guide provided by your||
2160|049|H|pharmacist before you start using amlodipine and celecoxib and||
2160|050|H|each time you get a refill. If you have any questions, ask your||
2160|051|H|doctor or pharmacist.||
2160|052|H|   Take this medication by mouth as directed by your doctor,||
2160|053|H|usually once daily. Take this medication with a full glass of||
2160|054|H|water (8 ounces or 240 milliliters) unless your doctor directs||
2160|055|H|you otherwise. Do not lie down for at least 10 minutes after||
2160|056|H|taking this medication. If stomach upset occurs while taking this||
2160|057|H|medication, take it with food, milk, or an antacid.||
2160|058|H|   The dosage is based on your medical condition and response to||
2160|059|H|treatment. To reduce your risk of stomach bleeding and other side||
2160|060|H|effects, take this medication at the lowest effective dose for||
2160|061|H|the shortest possible time. Do not increase your dose or use this||
2160|062|H|drug more often or for longer than prescribed. For ongoing||
2160|063|H|conditions such as arthritis, keep taking this medication as||
2160|064|H|directed. Discuss the risks and benefits with your doctor or||
2160|065|H|pharmacist.||
2160|066|H|   It may take up to two weeks of taking this drug regularly||
2160|067|H|before you get the full benefit.||
2160|068|B|||
2160|069|S|SIDE EFFECTS:  See also Warning section.||
2160|070|S|   Stomach upset, diarrhea, dizziness, gas, or swelling||
2160|071|S|ankles/feet may occur. If any of these effects last or get worse,||
2160|072|S|tell your doctor or pharmacist promptly.||
2160|073|S|   To reduce the risk of dizziness and lightheadedness, get up||
2160|074|S|slowly when rising from a sitting or lying position.||
2160|075|S|   Remember that this medication has been prescribed because your||
2160|076|S|doctor has judged that the benefit to you is greater than the||
2160|077|S|risk of side effects. Many people using this medication do not||
2160|078|S|have serious side effects.||
2160|079|S|   The celecoxib in this product may raise your blood pressure.||
2160|080|S|Check your blood pressure regularly and tell your doctor if the||
2160|081|S|results are high.||
2160|082|S|   Tell your doctor right away if you have any serious side||
2160|083|S|effects, including: pain/swelling/warmth in the groin/calf, signs||
2160|084|S|of kidney problems (such as change in the amount of urine),||
2160|085|S|difficult/painful swallowing, symptoms of heart failure (such as||
2160|086|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
2160|087|S|gain).||
2160|088|S|   Although this medication is effective in preventing chest pain||
2160|089|S|(angina), some people who already have severe heart disease may||
2160|090|S|rarely develop worsening chest pain or a heart attack after||
2160|091|S|starting this medication or increasing the dose. Get medical help||
2160|092|S|right away if you experience: worsening chest pain, symptoms of a||
2160|093|S|heart attack (such as chest/jaw/left arm pain, shortness of||
2160|094|S|breath, unusual sweating).||
2160|095|S|   This drug may rarely cause serious (possibly fatal) liver||
2160|096|S|disease. Get medical help right away if you have any symptoms of||
2160|097|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
2160|098|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2160|099|S|urine.||
2160|100|S|   A very serious allergic reaction to this drug is rare.||
2160|101|S|However, get medical help right away if you notice any symptoms||
2160|102|S|of a serious allergic reaction, including: fever, swollen lymph||
2160|103|S|nodes, rash, itching/swelling (especially of the||
2160|104|S|face/tongue/throat), severe dizziness, trouble breathing.||
2160|105|S|   This is not a complete list of possible side effects. If you||
2160|106|S|notice other effects not listed above, contact your doctor or||
2160|107|S|pharmacist.||
2160|108|S|   In the US -||
2160|109|S|   Call your doctor for medical advice about side effects. You||
2160|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2160|111|S|www.fda.gov/medwatch.||
2160|112|S|   In Canada - Call your doctor for medical advice about side||
2160|113|S|effects. You may report side effects to Health Canada at||
2160|114|S|1-866-234-2345.||
2160|115|B|||
2160|116|P|PRECAUTIONS:  See also Warning section.||
2160|117|P|   Before taking this product, tell your doctor or pharmacist if||
2160|118|P|you are allergic to amlodipine or celecoxib; or to aspirin, other||
2160|119|P|NSAIDs (such as ibuprofen, naproxen); or if you have any other||
2160|120|P|allergies. This product may contain inactive ingredients, which||
2160|121|P|can cause allergic reactions or other problems. Talk to your||
2160|122|P|pharmacist for more details.||
2160|123|P|   Before using this medication, tell your doctor or pharmacist||
2160|124|P|your medical history, especially of: asthma (including a history||
2160|125|P|of worsening breathing after taking aspirin or other NSAIDs),||
2160|126|P|bleeding/clotting problems, blood disorders (such as anemia),||
2160|127|P|growths in the nose (nasal polyps), heart disease (such as||
2160|128|P|angina, previous heart attack, aortic stenosis), high blood||
2160|129|P|pressure, liver disease, stroke, swelling (edema, fluid||
2160|130|P|retention), stomach/intestinal/esophagus problems (such as||
2160|131|P|bleeding, heartburn, ulcers).||
2160|132|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2160|133|P|can make you more dizzy. Do not drive, use machinery, or do||
2160|134|P|anything that needs alertness until you can do it safely. Limit||
2160|135|P|alcoholic beverages. Talk to your doctor if you are using||
2160|136|P|marijuana (cannabis).||
2160|137|P|   Kidney problems can sometimes occur with the use of NSAID||
2160|138|P|medications, including celecoxib. Problems are more likely to||
2160|139|P|occur if you are dehydrated, have heart failure or kidney||
2160|140|P|disease, are an older adult, or if you take certain medications||
2160|141|P|(see also Drug Interactions section). Drink plenty of fluids as||
2160|142|P|directed by your doctor to prevent dehydration and tell your||
2160|143|P|doctor right away if you have any unusual change in the amount of||
2160|144|P|urine.||
2160|145|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
2160|146|P|and tobacco, especially when combined with this medicine, may||
2160|147|P|increase your risk for stomach bleeding. Limit alcohol and stop||
2160|148|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
2160|149|P|may safely drink.||
2160|150|P|   Before having surgery, tell your doctor or dentist about all||
2160|151|P|the products you use (including prescription drugs,||
2160|152|P|nonprescription drugs, and herbal products).||
2160|153|P|   Older adults may be at greater risk for dizziness,||
2160|154|P|stomach/intestinal bleeding, kidney problems, heart attack, and||
2160|155|P|stroke while using this drug.||
2160|156|P|   Children with a certain type of arthritis (systemic onset||
2160|157|P|juvenile rheumatoid arthritis) may be at greater risk for a very||
2160|158|P|serious bleeding/clotting problem (disseminated intravascular||
2160|159|P|coagulation) while using this drug. Get medical help right away||
2160|160|P|if your child develops sudden bleeding/bruising or bluish skin in||
2160|161|P|the fingers/toes.||
2160|162|P|   Before using this medication, women of childbearing age should||
2160|163|P|talk with their doctor(s) about the benefits and risks. Tell your||
2160|164|P|doctor if you are pregnant or if you plan to become pregnant.||
2160|165|P|This medication may harm an unborn baby and cause problems with||
2160|166|P|normal labor/delivery. It is not recommended for use in pregnancy||
2160|167|P|from 20 weeks until delivery. If your doctor decides that you||
2160|168|P|need to use this medication between 20 and 30 weeks of pregnancy,||
2160|169|P|you should use the lowest effective dose for the shortest||
2160|170|P|possible time. You should not use this medication after 30 weeks||
2160|171|P|of pregnancy.||
2160|172|P|   This medication passes into breast milk. Consult your doctor||
2160|173|P|before breastfeeding.||
2160|174|B|||
2160|175|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2160|176|I|medications work or increase your risk for serious side effects.||
2160|177|I|This document does not contain all possible drug interactions.||
2160|178|I|Keep a list of all the products you use (including||
2160|179|I|prescription/nonprescription drugs and herbal products) and share||
2160|180|I|it with your doctor and pharmacist. Do not start, stop, or change||
2160|181|I|the dosage of any medicines without your doctor's approval.||
2160|182|I|   Some products that may interact with this drug are: aliskiren,||
2160|183|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
2160|184|I|receptor blockers (such as valsartan, losartan), cidofovir,||
2160|185|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
2160|186|I|methotrexate, "water pills" (diuretics such as furosemide).||
2160|187|I|   This medication may increase the risk of bleeding when taken||
2160|188|I|with other drugs that also may cause bleeding. Examples include||
2160|189|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2160|190|I|dabigatran/enoxaparin/warfarin, among others.||
2160|191|I|   Check all prescription and nonprescription medicine labels||
2160|192|I|carefully since many medications contain pain relievers/fever||
2160|193|I|reducers (including aspirin, NSAIDs such as naproxen, ibuprofen,||
2160|194|I|ketorolac). These drugs are similar to celecoxib and may increase||
2160|195|I|your risk of side effects if taken together. However, if your||
2160|196|I|doctor has told you to take low-dose aspirin to prevent heart||
2160|197|I|attack or stroke (usually 81-162 milligrams a day), you should||
2160|198|I|keep taking the aspirin unless your doctor tells you not to. Ask||
2160|199|I|your doctor or pharmacist for more details.||
2160|200|I|   Some products have ingredients that could raise your blood||
2160|201|I|pressure. Tell your pharmacist what products you are using, and||
2160|202|I|ask how to use them safely (especially cough-and-cold products,||
2160|203|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
2160|204|B|||
2160|205|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2160|206|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2160|207|O|poison control center right away. US residents can call||
2160|208|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2160|209|O|Symptoms of overdose may include severe stomach pain,||
2160|210|O|slow/shallow breathing, severe headache, or loss of||
2160|211|O|consciousness.||
2160|212|B|||
2160|213|N|NOTES:  Do not share this medication with others.||
2160|214|N|   Lab and/or medical tests (such as blood pressure, complete||
2160|215|N|blood count, liver and kidney function) may be done while you are||
2160|216|N|using this medication. Keep all medical and lab appointments.||
2160|217|N|   Lifestyle changes that may help this medication work better||
2160|218|N|include exercising, stopping smoking, and eating a||
2160|219|N|low-cholesterol/low-fat diet. Weight loss if needed and||
2160|220|N|strengthening/conditioning exercises may help improve your||
2160|221|N|flexibility and joint function. Consult your doctor for more||
2160|222|N|details.||
2160|223|N|   Check your blood pressure and pulse (heart rate) regularly||
2160|224|N|while taking this medication. Learn how to check your own blood||
2160|225|N|pressure and pulse at home, and share the results with your||
2160|226|N|doctor.||
2160|227|B|||
2160|228|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2160|229|D|remember. If it is near the time of the next dose, skip the||
2160|230|D|missed dose. Take your next dose at the regular time. Do not||
2160|231|D|double the dose to catch up.||
2160|232|B|||
2160|233|R|STORAGE:  Store at room temperature away from light and moisture.||
2160|234|R|Do not store in the bathroom. Keep all medications away from||
2160|235|R|children and pets.||
2160|236|R|   Do not flush medications down the toilet or pour them into a||
2160|237|R|drain unless instructed to do so. Properly discard this product||
2160|238|R|when it is expired or no longer needed. Consult your pharmacist||
2160|239|R|or local waste disposal company.||
2160|240|B|||
2160|241|A|Information last revised October 2025.||
2160|242|A|Copyright(c) 2025 First Databank, Inc.||
2160|243|B|||
2161|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2161|002|Z|does NOT have all possible information about this product. This||
2161|003|Z|information does not assure that this product is safe, effective,||
2161|004|Z|or appropriate for you. This information is not individual||
2161|005|Z|medical advice and does not substitute for the advice of your||
2161|006|Z|health care professional. Always ask your health care||
2161|007|Z|professional for complete information about this product and your||
2161|008|Z|specific health needs.||
2161|009|B|||
2161|010|T|CYCLOSPORINE 0.1% - OPHTHALMIC||
2161|011|F|(SYE-kloe-SPOR-in)||
2161|012|B|||
2161|013|C|COMMON BRAND NAME(S): Verkazia||
2161|014|B|||
2161|015|U|USES:  Cyclosporine eye drops are used to treat a certain serious||
2161|016|U|allergic eye condition (vernal keratoconjunctivitis). It works by||
2161|017|U|decreasing inflammation (swelling) in certain parts of your eyes,||
2161|018|U|including the clear layer at the front of the eye (cornea), and||
2161|019|U|the thin membrane covering the eye (conjunctiva). Treatment can||
2161|020|U|help prevent eye damage (such as ulcers).||
2161|021|B|||
2161|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2161|023|H|from your pharmacist before you start using cyclosporine and each||
2161|024|H|time you get a refill. If you have any questions, ask your doctor||
2161|025|H|or pharmacist.||
2161|026|H|   Use this medication in the affected eye(s) as directed by your||
2161|027|H|doctor, usually 4 times a day (morning, noon, afternoon, and||
2161|028|H|evening). If a child is using this medication, an adult should||
2161|029|H|help the child when starting treatment, especially if the child||
2161|030|H|is younger than 10 years old. Continue to help until the child is||
2161|031|H|able to properly use this medication without help.||
2161|032|H|   To apply eye drops, wash hands first. To avoid contamination,||
2161|033|H|do not touch the dropper tip or let it touch your eye or any||
2161|034|H|other surface.||
2161|035|H|   If you are wearing contact lenses, remove them before using||
2161|036|H|this medication. Gently shake the container before use. Remove||
2161|037|H|the cap. Tilt your head back, look upward, and pull down the||
2161|038|H|lower eyelid to make a pouch. Hold the dropper directly over your||
2161|039|H|eye and place one drop into the pouch. Blink a few times to||
2161|040|H|spread the medicine across your eye. Look downward, gently close||
2161|041|H|your eyes, and place one finger at the corner of your eye (near||
2161|042|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2161|043|H|opening your eyes. This will prevent the medication from draining||
2161|044|H|out. Try not to blink or rub your eye. If directed to use this||
2161|045|H|medication in both eyes, repeat these steps for your other eye.||
2161|046|H|Do not rinse the dropper.||
2161|047|H|   If you are using another kind of eye medication (such as drops||
2161|048|H|or ointments), wait at least 15 minutes before applying other||
2161|049|H|medications. Use eye drops before eye ointments to allow the||
2161|050|H|drops to enter the eye.||
2161|051|H|   The dosage is based on your medical condition and response to||
2161|052|H|treatment. If your symptoms improve, your doctor may decrease||
2161|053|H|your dose. Carefully follow your doctor's directions for all your||
2161|054|H|medications.||
2161|055|H|   Wait several minutes for your vision to clear before driving||
2161|056|H|or operating machinery.||
2161|057|H|   Use this medication regularly to get the most benefit from it.||
2161|058|H|To help you remember, use it at the same times each day as||
2161|059|H|directed by your doctor.||
2161|060|H|   If you are using the single-use form of this medication, throw||
2161|061|H|away the opened container after use. Do not save for later use.||
2161|062|H|   Tell your doctor if your condition does not get better or if||
2161|063|H|it gets worse.||
2161|064|B|||
2161|065|S|SIDE EFFECTS:  Eye discomfort/redness/itching, watery eyes,||
2161|066|S|feeling as if something is in the eye, eyelid swelling/redness,||
2161|067|S|or temporary blurred vision may occur. If any of these effects||
2161|068|S|last or get worse, tell your doctor or pharmacist promptly.||
2161|069|S|   Remember that this medication has been prescribed because your||
2161|070|S|doctor has judged that the benefit to you is greater than the||
2161|071|S|risk of side effects. Many people using this medication do not||
2161|072|S|have serious side effects.||
2161|073|S|   A very serious allergic reaction to this drug is rare.||
2161|074|S|However, get medical help right away if you notice any symptoms||
2161|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2161|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2161|077|S|breathing.||
2161|078|S|   This is not a complete list of possible side effects. If you||
2161|079|S|notice other effects not listed above, contact your doctor or||
2161|080|S|pharmacist.||
2161|081|S|   In the US -||
2161|082|S|   Call your doctor for medical advice about side effects. You||
2161|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2161|084|S|www.fda.gov/medwatch.||
2161|085|S|   In Canada - Call your doctor for medical advice about side||
2161|086|S|effects. You may report side effects to Health Canada at||
2161|087|S|1-866-234-2345.||
2161|088|B|||
2161|089|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2161|090|P|pharmacist if you are allergic to it; or if you have any other||
2161|091|P|allergies. This product may contain inactive ingredients, which||
2161|092|P|can cause allergic reactions or other problems. Talk to your||
2161|093|P|pharmacist for more details.||
2161|094|P|   Before using this medication, tell your doctor or pharmacist||
2161|095|P|your medical history, especially of: current/recent eye infection||
2161|096|P|(such as herpes or chickenpox in or near your eye), cancer or||
2161|097|P|precancerous condition in or around your eye.||
2161|098|P|   After you apply this drug, your vision may become temporarily||
2161|099|P|blurred. Do not drive, use machinery, or do anything that needs||
2161|100|P|clear vision until you can do it safely.||
2161|101|P|   Before having surgery, tell your doctor or dentist about all||
2161|102|P|the products you use (including prescription drugs,||
2161|103|P|nonprescription drugs, and herbal products).||
2161|104|P|   During pregnancy, this medication should be used only when||
2161|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
2161|106|P|   It is unknown if this drug passes into breast milk. Consult||
2161|107|P|your doctor before breastfeeding.||
2161|108|B|||
2161|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2161|110|I|medications work or increase your risk for serious side effects.||
2161|111|I|This document does not contain all possible drug interactions.||
2161|112|I|Keep a list of all the products you use (including||
2161|113|I|prescription/nonprescription drugs and herbal products) and share||
2161|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
2161|115|I|the dosage of any medicines without your doctor's approval.||
2161|116|B|||
2161|117|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2161|118|O|has overdosed and has serious symptoms such as passing out or||
2161|119|O|trouble breathing, call 911. Otherwise, call a poison control||
2161|120|O|center right away. US residents can call 1-800-222-1222. Canada||
2161|121|O|residents can call 1-844-764-7669.||
2161|122|B|||
2161|123|N|NOTES:  Do not share this medication with others.||
2161|124|N|   Avoid conditions and substances that can make your symptoms||
2161|125|N|worse, such as sun, wind, salt water, pollen, pet dander, dust||
2161|126|N|mites, mold, and smoke.||
2161|127|N|   Ask your doctor or pharmacist about other ways to help manage||
2161|128|N|your eye condition, such as applying cold compresses, using eye||
2161|129|N|lubricants (such as artificial tears), or wearing sunglasses when||
2161|130|N|outdoors.||
2161|131|B|||
2161|132|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2161|133|D|If it is near the time of the next dose, skip the missed dose.||
2161|134|D|Use your next dose at the regular time. Do not double the dose to||
2161|135|D|catch up.||
2161|136|B|||
2161|137|R|STORAGE:  Store at room temperature away from light. Do not||
2161|138|R|freeze. Keep the single-use vials in the foil pouch until ready||
2161|139|R|to use. Keep all medications away from children and pets.||
2161|140|R|   Do not flush medications down the toilet or pour them into a||
2161|141|R|drain unless instructed to do so. Properly discard this product||
2161|142|R|when it is expired or no longer needed. Consult your pharmacist||
2161|143|R|or local waste disposal company.||
2161|144|B|||
2161|145|A|Information last revised July 2025.||
2161|146|A|Copyright(c) 2025 First Databank, Inc.||
2161|147|B|||
2162|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2162|002|Z|does NOT have all possible information about this product. This||
2162|003|Z|information does not assure that this product is safe, effective,||
2162|004|Z|or appropriate for you. This information is not individual||
2162|005|Z|medical advice and does not substitute for the advice of your||
2162|006|Z|health care professional. Always ask your health care||
2162|007|Z|professional for complete information about this product and your||
2162|008|Z|specific health needs.||
2162|009|B|||
2162|010|T|IMIPENEM/CILASTATIN/RELEBACTAM - INJECTION||
2162|011|F|(IM-i-PEN-em/SYE-la-STAT-in/REL-e-BAK-tam)||
2162|012|B|||
2162|013|C|COMMON BRAND NAME(S): Recarbrio||
2162|014|B|||
2162|015|U|USES:  This medication is used to treat certain serious bacterial||
2162|016|U|infections (such as pneumonia, urinary tract or intra-abdominal||
2162|017|U|infections). This medication is known as a carbapenem-type||
2162|018|U|antibiotic. It works by stopping the growth of bacteria.||
2162|019|B|||
2162|020|H|HOW TO USE:  This medication is given by injection into a vein||
2162|021|H|over 30 minutes as directed by your doctor, usually every 6||
2162|022|H|hours. The dosage is based on your medical condition and response||
2162|023|H|to treatment.||
2162|024|H|   If you are using this medication at home, learn all||
2162|025|H|preparation and usage instructions from your health care||
2162|026|H|professional. Before using, check this product for particles or||
2162|027|H|discoloration. If either is present, do not use the liquid. Learn||
2162|028|H|how to store and discard medical supplies safely.||
2162|029|H|   For the best effect, use this antibiotic at evenly spaced||
2162|030|H|times. To help you remember, use this medication at the same||
2162|031|H|times every day.||
2162|032|H|   Continue to use this medication until the full prescribed||
2162|033|H|treatment period is finished, even if symptoms disappear after a||
2162|034|H|few days. Stopping the medication too early may result in a||
2162|035|H|return of the infection.||
2162|036|H|   Tell your doctor if your condition lasts or gets worse.||
2162|037|B|||
2162|038|S|SIDE EFFECTS:  Swelling, redness, or pain at the injection site||
2162|039|S|may occur. Nausea, vomiting, diarrhea, or headache may also||
2162|040|S|occur. If any of these effects last or get worse, tell your||
2162|041|S|doctor or pharmacist promptly.||
2162|042|S|   Remember that this medication has been prescribed because your||
2162|043|S|doctor has judged that the benefit to you is greater than the||
2162|044|S|risk of side effects. Many people using this medication do not||
2162|045|S|have serious side effects.||
2162|046|S|   Tell your doctor right away if you have any serious side||
2162|047|S|effects, including: mental/mood changes (such as agitation,||
2162|048|S|confusion), dark urine, yellowing eyes/skin, new signs of||
2162|049|S|infection (such as sore throat that doesn't go away, fever,||
2162|050|S|chills), unusual tiredness, fast heartbeat.||
2162|051|S|   Get medical help right away if you have any very serious side||
2162|052|S|effects, including: seizures.||
2162|053|S|   This medication may rarely cause a severe intestinal condition||
2162|054|S|due to a bacteria called C. difficile. This condition may occur||
2162|055|S|during treatment or weeks to months after treatment has stopped.||
2162|056|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2162|057|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2162|058|S|stool.||
2162|059|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2162|060|S|products because they may make symptoms worse.||
2162|061|S|   This medication may sometimes cause oral thrush or a new yeast||
2162|062|S|infection. Contact your doctor if you notice white patches in||
2162|063|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2162|064|S|   A very serious allergic reaction to this drug is rare.||
2162|065|S|However, get medical help right away if you notice any symptoms||
2162|066|S|of a serious allergic reaction, including: rash, itching/swelling||
2162|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2162|068|S|breathing.||
2162|069|S|   This is not a complete list of possible side effects. If you||
2162|070|S|notice other effects not listed above, contact your doctor or||
2162|071|S|pharmacist.||
2162|072|S|   In the US -||
2162|073|S|   Call your doctor for medical advice about side effects. You||
2162|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2162|075|S|www.fda.gov/medwatch.||
2162|076|S|   In Canada - Call your doctor for medical advice about side||
2162|077|S|effects. You may report side effects to Health Canada at||
2162|078|S|1-866-234-2345.||
2162|079|B|||
2162|080|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2162|081|P|pharmacist if you are allergic to imipenem, cilastatin, or||
2162|082|P|relebactam; or to other carbapenems (such as meropenem); or to||
2162|083|P|penicillins or cephalosporins; or if you have any other||
2162|084|P|allergies. This product may contain inactive ingredients, which||
2162|085|P|can cause allergic reactions or other problems. Talk to your||
2162|086|P|pharmacist for more details.||
2162|087|P|   Before using this medication, tell your doctor or pharmacist||
2162|088|P|your medical history, especially of: brain disorders (such as||
2162|089|P|seizures, head injury, tumor), kidney disease, stomach/intestinal||
2162|090|P|diseases (such as colitis).||
2162|091|P|   This medication may cause live bacterial vaccines (such as||
2162|092|P|typhoid vaccine) to not work well. Tell your health care||
2162|093|P|professional that you are using this medication before having any||
2162|094|P|immunizations/vaccinations.||
2162|095|P|   Before having surgery, tell your doctor or dentist about all||
2162|096|P|the products you use (including prescription drugs,||
2162|097|P|nonprescription drugs, and herbal products).||
2162|098|P|   During pregnancy, this medication should be used only when||
2162|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
2162|100|P|   Imipenem and cilastatin pass into breast milk. It is unknown||
2162|101|P|if relebactam passes into breast milk. Consult your doctor before||
2162|102|P|breastfeeding.||
2162|103|B|||
2162|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2162|105|I|medications work or increase your risk for serious side effects.||
2162|106|I|This document does not contain all possible drug interactions.||
2162|107|I|Keep a list of all the products you use (including||
2162|108|I|prescription/nonprescription drugs and herbal products) and share||
2162|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
2162|110|I|the dosage of any medicines without your doctor's approval.||
2162|111|I|   Some products that may interact with this drug are:||
2162|112|I|ganciclovir, valproic acid and related drugs (such as divalproex||
2162|113|I|sodium, sodium valproate).||
2162|114|I|   This medication may interfere with certain lab tests (such as||
2162|115|I|urine glucose), possibly causing false test results. Make sure||
2162|116|I|lab personnel and all your doctors know you use this drug.||
2162|117|B|||
2162|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2162|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2162|120|O|poison control center right away. US residents can call||
2162|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2162|122|O|Symptoms of overdose may include: seizures.||
2162|123|B|||
2162|124|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2162|125|N|kidney/liver function) may be done while you are using this||
2162|126|N|medication. Keep all medical and lab appointments. Consult your||
2162|127|N|doctor for more details.||
2162|128|B|||
2162|129|D|MISSED DOSE:  It is important to get each dose of this medication||
2162|130|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2162|131|D|right away for a new dosing schedule. Do not double the dose to||
2162|132|D|catch up.||
2162|133|B|||
2162|134|R|STORAGE:  Consult the product instructions and your pharmacist||
2162|135|R|for storage details. Keep all medications away from children and||
2162|136|R|pets.||
2162|137|R|   Do not flush medications down the toilet or pour them into a||
2162|138|R|drain unless instructed to do so. Properly discard this product||
2162|139|R|when it is expired or no longer needed. Consult your pharmacist||
2162|140|R|or local waste disposal company.||
2162|141|B|||
2162|142|A|Information last revised April 2025.||
2162|143|A|Copyright(c) 2025 First Databank, Inc.||
2162|144|B|||
2163|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2163|002|Z|does NOT have all possible information about this product. This||
2163|003|Z|information does not assure that this product is safe, effective,||
2163|004|Z|or appropriate for you. This information is not individual||
2163|005|Z|medical advice and does not substitute for the advice of your||
2163|006|Z|health care professional. Always ask your health care||
2163|007|Z|professional for complete information about this product and your||
2163|008|Z|specific health needs.||
2163|009|B|||
2163|010|T|AVAPRITINIB - ORAL||
2163|011|F|(A-va-PRI-ti-nib)||
2163|012|B|||
2163|013|C|COMMON BRAND NAME(S): Ayvakit||
2163|014|B|||
2163|015|U|USES:  This medication is used to treat a certain type of||
2163|016|U|stomach, bowel, or esophagus cancer (gastrointestinal stromal||
2163|017|U|tumor-GIST). Avapritinib is also be used to treat certain immune||
2163|018|U|system disorders (advanced systemic mastocytosis, indolent||
2163|019|U|systemic mastocytosis). Avapritinib belongs to a class of drugs||
2163|020|U|known as kinase inhibitors. It works by slowing or stopping the||
2163|021|U|growth of cancer cells and certain immune system cells (mast||
2163|022|U|cells).||
2163|023|B|||
2163|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2163|025|H|from your pharmacist before you start taking avapritinib and each||
2163|026|H|time you get a refill. If you have any questions, ask your doctor||
2163|027|H|or pharmacist.||
2163|028|H|   Take this medication by mouth on an empty stomach (at least 1||
2163|029|H|hour before or 2 hours after a meal) as directed by your doctor,||
2163|030|H|usually once daily. If you vomit after taking a dose, do not take||
2163|031|H|another dose. Take your next dose at the regular time.||
2163|032|H|   The dosage is based on your medical condition, response to||
2163|033|H|treatment, and other medications you may be taking. Be sure to||
2163|034|H|tell your doctor and pharmacist about all the products you use||
2163|035|H|(including prescription drugs, nonprescription drugs, and herbal||
2163|036|H|products).||
2163|037|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2163|038|H|using this medication unless your doctor or pharmacist says you||
2163|039|H|may do so safely. Grapefruit can increase the chance of side||
2163|040|H|effects with this medicine. Ask your doctor or pharmacist for||
2163|041|H|more details.||
2163|042|H|   Take this medication regularly to get the most benefit from||
2163|043|H|it. To help you remember, take it at the same time each day.||
2163|044|H|   Do not increase your dose or use this drug more often or for||
2163|045|H|longer than prescribed. Your condition will not improve any||
2163|046|H|faster, and your risk of serious side effects will increase.||
2163|047|H|   Since this drug can be absorbed through the skin and lungs and||
2163|048|H|may harm an unborn baby, women who are pregnant or who may become||
2163|049|H|pregnant should not handle this medication or breathe the dust||
2163|050|H|from the tablets.||
2163|051|B|||
2163|052|S|SIDE EFFECTS:  Dizziness, drowsiness, tiredness, muscle weakness,||
2163|053|S|swelling, watery eyes, diarrhea, loss of appetite, change in how||
2163|054|S|food tastes, stomach/abdominal pain, nausea, or vomiting may||
2163|055|S|occur. Nausea and vomiting can be severe. In some cases, your||
2163|056|S|doctor may prescribe medication to prevent or relieve nausea and||
2163|057|S|vomiting. Eating several small meals, not eating before||
2163|058|S|treatment, or limiting activity may help lessen some of these||
2163|059|S|effects. If any of these effects last or get worse, tell your||
2163|060|S|doctor or pharmacist promptly.||
2163|061|S|   Changes in hair color and temporary hair loss may occur.||
2163|062|S|Normal hair growth should return after treatment has ended.||
2163|063|S|   People using this medication may have serious side effects.||
2163|064|S|However, you have been prescribed this drug because your doctor||
2163|065|S|has judged that the benefit to you is greater than the risk of||
2163|066|S|side effects. Careful monitoring by your doctor may decrease your||
2163|067|S|risk.||
2163|068|S|   This medication can affect your thinking or mood, which can be||
2163|069|S|serious. Tell your doctor right away if you have any mental/mood||
2163|070|S|changes such as forgetfulness, confusion, trouble thinking||
2163|071|S|clearly, trouble finding words when talking, sleep problems, or||
2163|072|S|hallucinations. Changes in behavior may also occur. Tell your||
2163|073|S|doctor right away if you or a caregiver notice symptoms such as||
2163|074|S|agitation, depression, irritability, or personality changes.||
2163|075|S|   This medication can rarely increase the risk of bleeding in||
2163|076|S|the brain. Get medical help right away if you have any side||
2163|077|S|effects such as severe headache, vision problems, severe||
2163|078|S|drowsiness, or weakness on one side of your body.||
2163|079|S|   This medication may lower your ability to fight infections.||
2163|080|S|This may make you more likely to get a serious (rarely fatal)||
2163|081|S|infection or make any infection you have worse. Tell your doctor||
2163|082|S|right away if you have any signs of infection (such as sore||
2163|083|S|throat that doesn't go away, fever, chills).||
2163|084|S|   Avapritinib can commonly cause a rash that is usually not||
2163|085|S|serious. However, you may not be able to tell it apart from a||
2163|086|S|rare rash that could be a sign of a severe reaction. Get medical||
2163|087|S|help right away if you develop any rash.||
2163|088|S|   A very serious allergic reaction to this drug is rare.||
2163|089|S|However, get medical help right away if you notice any symptoms||
2163|090|S|of a serious allergic reaction, including: rash, itching/swelling||
2163|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2163|092|S|breathing.||
2163|093|S|   This is not a complete list of possible side effects. If you||
2163|094|S|notice other effects not listed above, contact your doctor or||
2163|095|S|pharmacist.||
2163|096|S|   In the US -||
2163|097|S|   Call your doctor for medical advice about side effects. You||
2163|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2163|099|S|www.fda.gov/medwatch.||
2163|100|S|   In Canada - Call your doctor for medical advice about side||
2163|101|S|effects. You may report side effects to Health Canada at||
2163|102|S|1-866-234-2345.||
2163|103|B|||
2163|104|P|PRECAUTIONS:  Before taking avapritinib, tell your doctor or||
2163|105|P|pharmacist if you are allergic to it; or if you have any other||
2163|106|P|allergies. This product may contain inactive ingredients, which||
2163|107|P|can cause allergic reactions or other problems. Talk to your||
2163|108|P|pharmacist for more details.||
2163|109|P|   Before using this medication, tell your doctor or pharmacist||
2163|110|P|your medical history, especially of: liver problems, kidney||
2163|111|P|problems, brain cancer, stroke/transient ischemic attack-TIA, a||
2163|112|P|certain blood disorder (low platelet counts).||
2163|113|P|   Avapritinib can make you more likely to get infections or may||
2163|114|P|make current infections worse. Stay away from anyone who has an||
2163|115|P|infection that may easily spread (such as chickenpox, COVID-19,||
2163|116|P|measles, flu). Talk to your doctor if you have been exposed to an||
2163|117|P|infection or for more details.||
2163|118|P|   Tell your health care professional that you are using||
2163|119|P|avapritinib before having any immunizations/vaccinations. Avoid||
2163|120|P|contact with people who have recently received live vaccines||
2163|121|P|(such as flu vaccine inhaled through the nose).||
2163|122|P|   To lower the chance of getting cut, bruised, or injured, use||
2163|123|P|caution with sharp objects like razors and nail cutters, and||
2163|124|P|avoid activities such as contact sports.||
2163|125|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2163|126|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2163|127|P|machinery, or do anything that needs alertness until you can do||
2163|128|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2163|129|P|are using marijuana (cannabis).||
2163|130|P|   This medication may make you more sensitive to the sun. Limit||
2163|131|P|your time in the sun during treatment and for 1 week after the||
2163|132|P|last dose. Avoid tanning booths and sunlamps. Use sunscreen and||
2163|133|P|wear protective clothing when outdoors. Tell your doctor right||
2163|134|P|away if you get sunburned or have skin blisters/redness. Your||
2163|135|P|doctor may direct you to limit or avoid phototherapy while you||
2163|136|P|use this product. Ask your doctor for details.||
2163|137|P|   Before having surgery, tell your doctor or dentist about all||
2163|138|P|the products you use (including prescription drugs,||
2163|139|P|nonprescription drugs, and herbal products).||
2163|140|P|   This medication can affect fertility in both males and||
2163|141|P|females. Ask your doctor for more details.||
2163|142|P|   Tell your doctor if you are pregnant or plan to become||
2163|143|P|pregnant. You should not become pregnant while using avapritinib.||
2163|144|P|Avapritinib may harm an unborn baby. Your doctor should order a||
2163|145|P|pregnancy test before you start this medication. Women using this||
2163|146|P|medication should ask about reliable forms of birth control||
2163|147|P|during treatment and for 6 weeks after the last dose. Men using||
2163|148|P|this medication should ask about reliable forms of birth control||
2163|149|P|during treatment and for some time after the last dose. If you or||
2163|150|P|your partner becomes pregnant, talk to your doctor right away||
2163|151|P|about the risks and benefits of this medication.||
2163|152|P|   Since this drug can be absorbed through the skin and lungs and||
2163|153|P|may harm an unborn baby, women who are pregnant or who may become||
2163|154|P|pregnant should not handle this medication or breathe the dust||
2163|155|P|from the tablets.||
2163|156|P|   It is unknown if this drug passes into breast milk. Because of||
2163|157|P|the possible risk to the infant, breastfeeding is not recommended||
2163|158|P|while using this drug and for 2 weeks after the last dose.||
2163|159|P|Consult your doctor before breastfeeding.||
2163|160|B|||
2163|161|I|DRUG INTERACTIONS:  See also How to Use section.||
2163|162|I|   Drug interactions may change how your medications work or||
2163|163|I|increase your risk for serious side effects. This document does||
2163|164|I|not contain all possible drug interactions. Keep a list of all||
2163|165|I|the products you use (including prescription/nonprescription||
2163|166|I|drugs and herbal products) and share it with your doctor and||
2163|167|I|pharmacist. Do not start, stop, or change the dosage of any||
2163|168|I|medicines without your doctor's approval.||
2163|169|I|   Other medications can affect the removal of avapritinib from||
2163|170|I|your body, which may affect how avapritinib works. Examples||
2163|171|I|include azole antifungals (such as fluconazole, itraconazole),||
2163|172|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
2163|173|I|rifampin, rifabutin), St. John's wort, drugs used to treat||
2163|174|I|seizures (such as carbamazepine, phenytoin), among others.||
2163|175|B|||
2163|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2163|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2163|178|O|poison control center right away. US residents can call||
2163|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2163|180|B|||
2163|181|N|NOTES:  Do not share this medication with others.||
2163|182|N|   Lab and/or medical tests (such as complete blood count, liver||
2163|183|N|function) should be done while you are taking this medication.||
2163|184|N|Keep all medical and lab appointments.||
2163|185|B|||
2163|186|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2163|187|D|remember. If it is within 8 hours of the next dose, skip the||
2163|188|D|missed dose. Take your next dose at the regular time. Do not||
2163|189|D|double the dose to catch up.||
2163|190|B|||
2163|191|R|STORAGE:  Store at room temperature away from light and moisture.||
2163|192|R|Do not store in the bathroom. Keep all medications away from||
2163|193|R|children and pets.||
2163|194|R|   Do not flush medications down the toilet or pour them into a||
2163|195|R|drain unless instructed to do so. Properly discard this product||
2163|196|R|when it is expired or no longer needed. Consult your pharmacist||
2163|197|R|or local waste disposal company.||
2163|198|B|||
2163|199|M|MEDICAL ALERT:  Your condition can cause complications in a||
2163|200|M|medical emergency. For information about enrolling in MedicAlert,||
2163|201|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2163|202|B|||
2163|203|A|Information last revised April 2025.||
2163|204|A|Copyright(c) 2025 First Databank, Inc.||
2163|205|B|||
2164|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2164|002|Z|does NOT have all possible information about this product. This||
2164|003|Z|information does not assure that this product is safe, effective,||
2164|004|Z|or appropriate for you. This information is not individual||
2164|005|Z|medical advice and does not substitute for the advice of your||
2164|006|Z|health care professional. Always ask your health care||
2164|007|Z|professional for complete information about this product and your||
2164|008|Z|specific health needs.||
2164|009|B|||
2164|010|T|DIAZEPAM SPRAY - NASAL||
2164|011|F|(dye-AZ-e-pam)||
2164|012|B|||
2164|013|C|COMMON BRAND NAME(S): Valtoco||
2164|014|B|||
2164|015|W|WARNING:  Diazepam has a risk for abuse and addiction, which can||
2164|016|W|lead to overdose and death. Using this medication with alcohol or||
2164|017|W|other drugs that can cause drowsiness or breathing problems||
2164|018|W|(especially opioid medications such as codeine, hydrocodone) may||
2164|019|W|cause very serious side effects, including death. To lower your||
2164|020|W|risk, your doctor should have you use the smallest dose of||
2164|021|W|diazepam that works, and use it for the shortest possible time.||
2164|022|W|Be sure you know how to use diazepam and what other drugs you||
2164|023|W|should avoid taking with it. See also Drug Interactions section.||
2164|024|W|Get medical help right away if any of these very serious side||
2164|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
2164|026|W|severe drowsiness/dizziness, difficulty waking up.||
2164|027|W|   This medication should not be used regularly. If you use it||
2164|028|W|regularly, suddenly stopping this medication may cause serious||
2164|029|W|(possibly fatal) withdrawal, especially if you have used it for a||
2164|030|W|long time or in high doses. To prevent withdrawal, your doctor||
2164|031|W|may lower your dose slowly. Tell your doctor or pharmacist right||
2164|032|W|away if you have any withdrawal symptoms such as headaches,||
2164|033|W|trouble sleeping, restlessness, hallucinations/confusion,||
2164|034|W|depression, nausea, or seizures. Withdrawal symptoms may||
2164|035|W|sometimes last weeks to months.||
2164|036|B|||
2164|037|U|USES:  This medication is used by people with epilepsy to treat a||
2164|038|U|certain type of serious seizure that doesn't stop (seizure||
2164|039|U|clusters). Diazepam belongs to a class of drugs known as||
2164|040|U|benzodiazepines. It may work by increasing the effect of a||
2164|041|U|certain substance in your body (GABA), which helps calm the brain||
2164|042|U|and nerves.||
2164|043|B|||
2164|044|H|HOW TO USE:  See also Warning section.||
2164|045|H|   Read the Medication Guide and Instructions for Use provided by||
2164|046|H|your pharmacist when you get this medication and each time you||
2164|047|H|get a refill. Be sure to keep this medication handy in case it is||
2164|048|H|needed. Learn ahead of time how to properly use this medication.||
2164|049|H|Each nasal spray device can be used only one time. If you have||
2164|050|H|any questions, ask your doctor or pharmacist.||
2164|051|H|   Caregivers should learn when this medication should be used||
2164|052|H|and what to watch for after using this medication. Make sure a||
2164|053|H|family member or caregiver knows where you keep this medication||
2164|054|H|and how to use it in case you need their help.||
2164|055|H|   This product is for use in the nose only. The dosage is based||
2164|056|H|on your age, weight, and response to treatment. Remove the||
2164|057|H|diazepam spray from the package only when you are ready to use||
2164|058|H|it. Do not test or prime the spray before use. Doing so will make||
2164|059|H|you lose the dose. Gently insert the tip of the spray nozzle into||
2164|060|H|one nostril, then firmly press the plunger to give the dose. Each||
2164|061|H|nasal spray device only has one spray. If your dose is for 2||
2164|062|H|sprays, use a second nasal spray device in the opposite nostril.||
2164|063|H|Throw away the nasal spray device after using it.||
2164|064|H|   In some cases, a second dose may be prescribed and given at||
2164|065|H|least 4 hours after the first dose. Do not use more than 2 doses||
2164|066|H|to treat a seizure cluster episode.||
2164|067|H|   Do not use this product to treat episodes more often than once||
2164|068|H|every 5 days, or more than 5 times in a month. Doing so may make||
2164|069|H|this medication stop working well. Your seizures may get worse or||
2164|070|H|happen more often. Talk with your doctor if this medication stops||
2164|071|H|working well.||
2164|072|H|   Though it helps many people, this medication may sometimes||
2164|073|H|cause addiction. This risk may be higher if you have a substance||
2164|074|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2164|075|H|Use this medication exactly as prescribed to lower the risk of||
2164|076|H|addiction. Ask your doctor or pharmacist for more details.||
2164|077|H|   Get emergency help right away if seizures last or get worse||
2164|078|H|after using the medication as directed, or if there is a change||
2164|079|H|in the person's breathing, coloring, behavior, or condition that||
2164|080|H|alarms you.||
2164|081|B|||
2164|082|S|SIDE EFFECTS:  See also Warning section.||
2164|083|S|   Drowsiness, dizziness, diarrhea, nosebleed, or nasal||
2164|084|S|discomfort may occur. If any of these effects last or get worse,||
2164|085|S|tell your doctor or pharmacist promptly.||
2164|086|S|   Remember that this medication has been prescribed because your||
2164|087|S|doctor has judged that the benefit to you is greater than the||
2164|088|S|risk of side effects. Many people using this medication do not||
2164|089|S|have serious side effects.||
2164|090|S|   Tell your doctor right away if you have any serious side||
2164|091|S|effects, including: uncontrolled movements (such as||
2164|092|S|shaking/tremor).||
2164|093|S|   Get medical help right away if you have any very serious side||
2164|094|S|effects, including: slow/shallow breathing, unusual||
2164|095|S|drowsiness/difficulty waking up.||
2164|096|S|   A small number of people who take anticonvulsants for any||
2164|097|S|condition (such as seizure, bipolar disorder, pain) may||
2164|098|S|experience depression, suicidal thoughts/attempts, or other||
2164|099|S|mental/mood problems. Tell your doctor right away if you or your||
2164|100|S|family/caregiver notice any unusual/sudden changes in your mood,||
2164|101|S|thoughts, or behavior such as signs of depression, suicidal||
2164|102|S|thoughts/attempts, thoughts about harming yourself.||
2164|103|S|   A very serious allergic reaction to this drug is rare.||
2164|104|S|However, get medical help right away if you notice any symptoms||
2164|105|S|of a serious allergic reaction, including: rash, itching/swelling||
2164|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2164|107|S|breathing.||
2164|108|S|   This is not a complete list of possible side effects. If you||
2164|109|S|notice other effects not listed above, contact your doctor or||
2164|110|S|pharmacist.||
2164|111|S|   In the US -||
2164|112|S|   Call your doctor for medical advice about side effects. You||
2164|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2164|114|S|www.fda.gov/medwatch.||
2164|115|S|   In Canada - Call your doctor for medical advice about side||
2164|116|S|effects. You may report side effects to Health Canada at||
2164|117|S|1-866-234-2345.||
2164|118|B|||
2164|119|P|PRECAUTIONS:  Before using diazepam, tell your doctor or||
2164|120|P|pharmacist if you are allergic to it; or to other benzodiazepines||
2164|121|P|(such as lorazepam); or if you have any other allergies. This||
2164|122|P|product may contain inactive ingredients which can cause allergic||
2164|123|P|reactions or other problems. Talk to your pharmacist for more||
2164|124|P|details.||
2164|125|P|   Before using this medication, tell your doctor or pharmacist||
2164|126|P|your medical history, especially of: glaucoma, breathing problems||
2164|127|P|(such as chronic obstructive lung disease-COPD, asthma), personal||
2164|128|P|or family history of a substance use disorder (such as overuse of||
2164|129|P|or addiction to drugs/alcohol), mental/mood disorders (such as||
2164|130|P|depression, thoughts of suicide, psychosis).||
2164|131|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2164|132|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2164|133|P|machinery, or do anything that needs alertness until you can do||
2164|134|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2164|135|P|are using marijuana (cannabis).||
2164|136|P|   Before having surgery, tell your doctor or dentist about all||
2164|137|P|the products you use (including prescription drugs,||
2164|138|P|nonprescription drugs, and herbal products).||
2164|139|P|   During pregnancy, this medication should be used only when||
2164|140|P|clearly needed. It may harm an unborn baby. Newborn babies of||
2164|141|P|mothers who use this medication late in pregnancy may have||
2164|142|P|symptoms such as slow/shallow breathing, nonstop crying, shaking,||
2164|143|P|or trouble feeding. However, since untreated seizures are a||
2164|144|P|serious condition that can harm both a pregnant woman and her||
2164|145|P|unborn baby, do not stop taking this medication unless directed||
2164|146|P|by your doctor. If you are planning pregnancy, become pregnant,||
2164|147|P|or think you may be pregnant, talk to your doctor right away||
2164|148|P|about the risks and benefits of this medication.||
2164|149|P|   This drug passes into breast milk and may have undesirable||
2164|150|P|effects on a nursing infant. Consult your doctor before||
2164|151|P|breastfeeding.||
2164|152|B|||
2164|153|I|DRUG INTERACTIONS:  See also Warning section.||
2164|154|I|   Drug interactions may change how your medications work or||
2164|155|I|increase your risk for serious side effects. This document does||
2164|156|I|not contain all possible drug interactions. Keep a list of all||
2164|157|I|the products you use (including prescription/nonprescription||
2164|158|I|drugs and herbal products) and share it with your doctor and||
2164|159|I|pharmacist. Do not start, stop, or change the dosage of any||
2164|160|I|medicines without your doctor's approval.||
2164|161|I|   A product that may interact with this drug is: sodium oxybate.||
2164|162|I|   The risk of serious side effects (such as slow/shallow||
2164|163|I|breathing, severe drowsiness/dizziness) may be increased if this||
2164|164|I|medication is used with other products that may also cause||
2164|165|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2164|166|I|if you are using other products such as opioid pain or cough||
2164|167|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2164|168|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2164|169|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2164|170|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2164|171|I|diphenhydramine).||
2164|172|I|   Check the labels on all your medicines (such as allergy or||
2164|173|I|cough-and-cold products) because they may contain ingredients||
2164|174|I|that cause drowsiness. Ask your pharmacist about using those||
2164|175|I|products safely.||
2164|176|B|||
2164|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2164|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2164|179|O|poison control center right away. US residents can call||
2164|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2164|181|O|Symptoms of overdose may include: confusion, slow/shallow||
2164|182|O|breathing, coma.||
2164|183|B|||
2164|184|N|NOTES:  Do not share this medication with others. Sharing it is||
2164|185|N|against the law.||
2164|186|B|||
2164|187|D|MISSED DOSE:  Not applicable.||
2164|188|B|||
2164|189|R|STORAGE:  Store at room temperature away from light. Do not||
2164|190|R|freeze. Do not remove the nasal spray from the package until you||
2164|191|R|are ready to use it. Keep all medications away from children and||
2164|192|R|pets.||
2164|193|R|   Do not flush medications down the toilet or pour them into a||
2164|194|R|drain unless instructed to do so. Properly discard this product||
2164|195|R|when it is expired or no longer needed. Consult your pharmacist||
2164|196|R|or local waste disposal company.||
2164|197|B|||
2164|198|M|MEDICAL ALERT:  Your condition can cause complications in a||
2164|199|M|medical emergency. For information about enrolling in MedicAlert,||
2164|200|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2164|201|B|||
2164|202|A|Information last revised March 2025.||
2164|203|A|Copyright(c) 2025 First Databank, Inc.||
2164|204|B|||
2165|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2165|002|Z|does NOT have all possible information about this product. This||
2165|003|Z|information does not assure that this product is safe, effective,||
2165|004|Z|or appropriate for you. This information is not individual||
2165|005|Z|medical advice and does not substitute for the advice of your||
2165|006|Z|health care professional. Always ask your health care||
2165|007|Z|professional for complete information about this product and your||
2165|008|Z|specific health needs.||
2165|009|B|||
2165|010|T|LUMATEPERONE - ORAL||
2165|011|F|(LOO-ma-TE-per-one)||
2165|012|B|||
2165|013|C|COMMON BRAND NAME(S): Caplyta||
2165|014|B|||
2165|015|W|WARNING:  There may be a slightly increased risk of serious,||
2165|016|W|possibly fatal side effects (such as stroke, heart failure,||
2165|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
2165|018|W|by older adults with dementia. This medication is not approved||
2165|019|W|for the treatment of dementia-related behavior problems. Discuss||
2165|020|W|the risks and benefits of this medication, as well as other||
2165|021|W|effective and possibly safer treatments for dementia-related||
2165|022|W|behavior problems, with the doctor.||
2165|023|W|   Lumateperone is used to treat certain mental/mood disorders||
2165|024|W|(such as schizophrenia, episodes of depression associated with||
2165|025|W|bipolar disorder). Drugs used to treat depression can help||
2165|026|W|prevent suicidal thoughts/attempts and provide other important||
2165|027|W|benefits. However, studies have shown that a small number of||
2165|028|W|people (especially people younger than 25) who take drugs to||
2165|029|W|treat depression may experience worsening depression, other||
2165|030|W|mental/mood symptoms, or suicidal thoughts/attempts. It is very||
2165|031|W|important to talk with the doctor about the risks and benefits of||
2165|032|W|drugs used to treat depression (especially for people younger||
2165|033|W|than 25), even if treatment is not for a mental/mood condition.||
2165|034|W|   Tell the doctor right away if you notice worsening||
2165|035|W|depression/other psychiatric conditions, unusual behavior changes||
2165|036|W|(including possible suicidal thoughts/attempts), or other||
2165|037|W|mental/mood changes (including new/worsening anxiety, panic||
2165|038|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2165|039|W|impulsive actions, severe restlessness, very rapid speech). Be||
2165|040|W|especially watchful for these symptoms when a new drug to treat||
2165|041|W|depression is started or when the dose is changed.||
2165|042|B|||
2165|043|U|USES:  This medication is used to treat certain mental/mood||
2165|044|U|disorders (such as schizophrenia, episodes of depression||
2165|045|U|associated with bipolar disorder). It may also be used in||
2165|046|U|combination with other medications to treat depression.||
2165|047|U|Lumateperone belongs to a class of drugs known as atypical||
2165|048|U|antipsychotics. It works by helping to restore the balance of||
2165|049|U|certain natural substances in the brain.||
2165|050|B|||
2165|051|H|HOW TO USE:  Read the Medication Guide provided by your||
2165|052|H|pharmacist before you start taking lumateperone and each time you||
2165|053|H|get a refill. If you have any questions, ask your doctor or||
2165|054|H|pharmacist.||
2165|055|H|   Take this medication by mouth with or without food as directed||
2165|056|H|by your doctor, usually once daily.||
2165|057|H|   The dosage is based on your medical condition, response to||
2165|058|H|treatment, and other medications you may be taking. Be sure to||
2165|059|H|tell your doctor and pharmacist about all the products you use||
2165|060|H|(including prescription drugs, nonprescription drugs, and herbal||
2165|061|H|products).||
2165|062|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2165|063|H|using this medication unless your doctor or pharmacist says you||
2165|064|H|may do so safely. Grapefruit can increase the chance of side||
2165|065|H|effects with this medicine. Ask your doctor or pharmacist for||
2165|066|H|more details.||
2165|067|H|   Take this medication regularly to get the most benefit from||
2165|068|H|it. To help you remember, take it at the same time each day. Keep||
2165|069|H|taking this medication exactly as prescribed, even if you are||
2165|070|H|feeling better and thinking more clearly. Do not increase your||
2165|071|H|dose or take this drug more often than prescribed. Your symptoms||
2165|072|H|will not improve any faster, and your risk of side effects will||
2165|073|H|increase. Do not stop taking this medication without consulting||
2165|074|H|your doctor.||
2165|075|H|   Tell your doctor if your condition does not get better or if||
2165|076|H|it gets worse.||
2165|077|B|||
2165|078|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, dry mouth,||
2165|079|S|diarrhea, or nausea may occur. If any of these effects last or||
2165|080|S|get worse, tell your doctor or pharmacist promptly.||
2165|081|S|   Dizziness and lightheadedness can increase the risk of||
2165|082|S|falling. Get up slowly when rising from a sitting or lying||
2165|083|S|position.||
2165|084|S|   Remember that this medication has been prescribed because your||
2165|085|S|doctor has judged that the benefit to you is greater than the||
2165|086|S|risk of side effects. Many people using this medication do not||
2165|087|S|have serious side effects.||
2165|088|S|   Tell your doctor right away if you have any serious side||
2165|089|S|effects, including: difficulty swallowing, interrupted breathing||
2165|090|S|during sleep (sleep apnea), signs of infection (such as sore||
2165|091|S|throat that doesn't go away, fever, chills).||
2165|092|S|   This medication may rarely make your blood sugar rise, which||
2165|093|S|can cause or worsen diabetes. Tell your doctor right away if you||
2165|094|S|have symptoms of high blood sugar such as increased||
2165|095|S|thirst/urination. If you already have diabetes, check your blood||
2165|096|S|sugar regularly as directed and share the results with your||
2165|097|S|doctor. Your doctor may need to adjust your diabetes medication,||
2165|098|S|exercise program, or diet.||
2165|099|S|   This drug may also cause significant weight gain and a rise in||
2165|100|S|your blood cholesterol (or triglyceride) levels. These effects,||
2165|101|S|along with diabetes, may increase your risk for developing heart||
2165|102|S|disease. Discuss the risks and benefits of treatment with your||
2165|103|S|doctor. (See also Notes section.)||
2165|104|S|   Lumateperone may rarely cause a condition known as tardive||
2165|105|S|dyskinesia. In some cases, this condition may be permanent. Tell||
2165|106|S|your doctor right away if you develop any unusual/uncontrolled||
2165|107|S|movements (especially of the face, lips, mouth, tongue, arms or||
2165|108|S|legs).||
2165|109|S|   Get medical help right away if you have any very serious side||
2165|110|S|effects, including: seizures.||
2165|111|S|   This medication may rarely cause a very serious condition||
2165|112|S|called neuroleptic malignant syndrome (NMS). Get medical help||
2165|113|S|right away if you have any of the following symptoms: fever,||
2165|114|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
2165|115|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
2165|116|S|signs of kidney problems (such as change in the amount of urine).||
2165|117|S|   A very serious allergic reaction to this drug is rare.||
2165|118|S|However, get medical help right away if you notice any symptoms||
2165|119|S|of a serious allergic reaction, including: rash, itching/swelling||
2165|120|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2165|121|S|breathing.||
2165|122|S|   This is not a complete list of possible side effects. If you||
2165|123|S|notice other effects not listed above, contact your doctor or||
2165|124|S|pharmacist.||
2165|125|S|   In the US -||
2165|126|S|   Call your doctor for medical advice about side effects. You||
2165|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2165|128|S|www.fda.gov/medwatch.||
2165|129|S|   In Canada - Call your doctor for medical advice about side||
2165|130|S|effects. You may report side effects to Health Canada at||
2165|131|S|1-866-234-2345.||
2165|132|B|||
2165|133|P|PRECAUTIONS:  Before taking lumateperone, tell your doctor or||
2165|134|P|pharmacist if you are allergic to it; or if you have any other||
2165|135|P|allergies. This product may contain inactive ingredients, which||
2165|136|P|can cause allergic reactions or other problems. Talk to your||
2165|137|P|pharmacist for more details.||
2165|138|P|   Before using this medication, tell your doctor or pharmacist||
2165|139|P|your medical history, especially of: liver disease, seizures,||
2165|140|P|difficulty swallowing, low white blood cell count, Parkinson's||
2165|141|P|disease, dementia, personal or family history of diabetes, heart||
2165|142|P|disease, high cholesterol/triglyceride levels, breathing trouble||
2165|143|P|during sleep (sleep apnea).||
2165|144|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2165|145|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2165|146|P|machinery, or do anything that needs alertness until you can do||
2165|147|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2165|148|P|are using marijuana (cannabis).||
2165|149|P|   Before having surgery, tell your doctor or dentist about all||
2165|150|P|the products you use (including prescription drugs,||
2165|151|P|nonprescription drugs, and herbal products).||
2165|152|P|   This medication may make you sweat less, making you more||
2165|153|P|likely to get heat stroke. Avoid doing things that may cause you||
2165|154|P|to overheat, such as hard work or exercise in hot weather, or||
2165|155|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2165|156|P|and dress lightly. If you overheat, quickly look for a place to||
2165|157|P|cool down and rest. Get medical help right away if you have a||
2165|158|P|fever that does not go away, mental/mood changes, headache, or||
2165|159|P|dizziness.||
2165|160|P|   Older adults may be more sensitive to the side effects of this||
2165|161|P|drug, especially drowsiness, dizziness, and lightheadedness.||
2165|162|P|Drowsiness, dizziness, and lightheadedness can increase the risk||
2165|163|P|of falling.||
2165|164|P|   During pregnancy, this medication should be used only when||
2165|165|P|clearly needed. Babies born to mothers who have used this drug||
2165|166|P|during the last 3 months of pregnancy may rarely develop symptoms||
2165|167|P|including muscle stiffness or shakiness, drowsiness,||
2165|168|P|feeding/breathing difficulties, or constant crying. If you notice||
2165|169|P|any of these symptoms in your newborn especially during their||
2165|170|P|first month, tell the doctor right away.||
2165|171|P|   Since untreated mental/mood problems (such as schizophrenia)||
2165|172|P|can be a serious condition, do not stop taking this medication||
2165|173|P|unless directed by your doctor. If you are planning pregnancy,||
2165|174|P|become pregnant, or think you may be pregnant, discuss with your||
2165|175|P|doctor right away the benefits and risks of using this medication||
2165|176|P|during pregnancy.||
2165|177|P|   This medication passes into breast milk. Consult your doctor||
2165|178|P|before breastfeeding.||
2165|179|B|||
2165|180|I|DRUG INTERACTIONS:  See also How to Use section.||
2165|181|I|   Drug interactions may change how your medications work or||
2165|182|I|increase your risk for serious side effects. This document does||
2165|183|I|not contain all possible drug interactions. Keep a list of all||
2165|184|I|the products you use (including prescription/nonprescription||
2165|185|I|drugs and herbal products) and share it with your doctor and||
2165|186|I|pharmacist. Do not start, stop, or change the dosage of any||
2165|187|I|medicines without your doctor's approval.||
2165|188|I|   A product that may interact with this drug is: metoclopramide.||
2165|189|I|   Other medications can affect the removal of lumateperone from||
2165|190|I|your body, which may affect how lumateperone works. Examples||
2165|191|I|include rifamycins (such as rifabutin), St. John's wort, drugs||
2165|192|I|used to treat seizures (such as carbamazepine, phenytoin), among||
2165|193|I|others.||
2165|194|I|   Tell your doctor or pharmacist if you are taking other||
2165|195|I|products that cause drowsiness such as opioid pain or cough||
2165|196|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2165|197|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2165|198|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2165|199|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2165|200|I|diphenhydramine).||
2165|201|I|   Check the labels on all your medicines (such as allergy or||
2165|202|I|cough-and-cold products) because they may contain ingredients||
2165|203|I|that cause drowsiness. Ask your pharmacist about using those||
2165|204|I|products safely.||
2165|205|B|||
2165|206|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2165|207|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2165|208|O|poison control center right away. US residents can call||
2165|209|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2165|210|B|||
2165|211|N|NOTES:  Do not share this medication with others.||
2165|212|N|   Lab and/or medical tests (such as blood sugar, weight, blood||
2165|213|N|pressure, blood cholesterol/triglyceride levels) should be done||
2165|214|N|while you are taking this medication. Keep all medical and lab||
2165|215|N|appointments. Consult your doctor for more details.||
2165|216|B|||
2165|217|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2165|218|D|remember. If it is near the time of the next dose, skip the||
2165|219|D|missed dose. Take your next dose at the regular time. Do not||
2165|220|D|double the dose to catch up.||
2165|221|B|||
2165|222|R|STORAGE:  Store at room temperature away from light and moisture.||
2165|223|R|Do not store in the bathroom. Keep all medications away from||
2165|224|R|children and pets.||
2165|225|R|   Do not flush medications down the toilet or pour them into a||
2165|226|R|drain unless instructed to do so. Properly discard this product||
2165|227|R|when it is expired or no longer needed. Consult your pharmacist||
2165|228|R|or local waste disposal company.||
2165|229|B|||
2165|230|A|Information last revised November 2025.||
2165|231|A|Copyright(c) 2025 First Databank, Inc.||
2165|232|B|||
2166|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2166|002|Z|does NOT have all possible information about this product. This||
2166|003|Z|information does not assure that this product is safe, effective,||
2166|004|Z|or appropriate for you. This information is not individual||
2166|005|Z|medical advice and does not substitute for the advice of your||
2166|006|Z|health care professional. Always ask your health care||
2166|007|Z|professional for complete information about this product and your||
2166|008|Z|specific health needs.||
2166|009|B|||
2166|010|T|UBROGEPANT - ORAL||
2166|011|F|(ue-BROE-je-pant)||
2166|012|B|||
2166|013|C|COMMON BRAND NAME(S): Ubrelvy||
2166|014|B|||
2166|015|U|USES:  This medication is used to treat migraine. Ubrogepant may||
2166|016|U|work by changing the amount of a certain natural substance in the||
2166|017|U|brain. It helps to relieve headache, pain, and other migraine||
2166|018|U|symptoms (including nausea, vomiting, sensitivity to||
2166|019|U|light/sound). Prompt treatment helps you return to your normal||
2166|020|U|routine and may decrease your need for other pain medications.||
2166|021|U|   This medication is not used to prevent future migraines or||
2166|022|U|lessen how often you get migraines.||
2166|023|B|||
2166|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2166|025|H|from your pharmacist before you start taking ubrogepant and each||
2166|026|H|time you get a refill. If you have any questions, ask your doctor||
2166|027|H|or pharmacist.||
2166|028|H|   Take this medication by mouth with or without food as directed||
2166|029|H|by your doctor, at the first sign of a migraine. The dosage is||
2166|030|H|based on your medical condition, response to treatment, and other||
2166|031|H|medications you may be taking. Be sure to tell your doctor and||
2166|032|H|pharmacist about all the products you use (including prescription||
2166|033|H|drugs, nonprescription drugs, and herbal products). If needed,||
2166|034|H|most people can take a second tablet 2 hours after the first||
2166|035|H|tablet. You should not take a second tablet within 24 hours if||
2166|036|H|you consume grapefruit or grapefruit juice or if you are taking||
2166|037|H|certain other medications (see also Drug Interactions section).||
2166|038|H|Do not take more than 200 milligrams in a 24-hour period. Ask||
2166|039|H|your doctor or pharmacist if you are not sure if or when it is||
2166|040|H|safe to take a second dose.||
2166|041|H|   It is not known if it is safe to take this medication for more||
2166|042|H|than 8 migraines within 30 days.||
2166|043|H|   Tell your doctor if your condition does not get better or if||
2166|044|H|it gets worse.||
2166|045|B|||
2166|046|S|SIDE EFFECTS:  Nausea or drowsiness may occur. If either of these||
2166|047|S|effects lasts or gets worse, tell your doctor or pharmacist||
2166|048|S|promptly.||
2166|049|S|   Remember that this medication has been prescribed because your||
2166|050|S|doctor has judged that the benefit to you is greater than the||
2166|051|S|risk of side effects. Many people using this medication do not||
2166|052|S|have serious side effects.||
2166|053|S|   This medication may raise your blood pressure. Check your||
2166|054|S|blood pressure regularly and tell your doctor if the results are||
2166|055|S|high. Your doctor may control your blood pressure with||
2166|056|S|medication.||
2166|057|S|   Tell your doctor right away if you have any serious side||
2166|058|S|effects, including: blue fingers/toes, cold hands/feet.||
2166|059|S|   A very serious allergic reaction to this drug is rare.||
2166|060|S|However, get medical help right away if you notice any symptoms||
2166|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2166|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2166|063|S|breathing.||
2166|064|S|   This is not a complete list of possible side effects. If you||
2166|065|S|notice other effects not listed above, contact your doctor or||
2166|066|S|pharmacist.||
2166|067|S|   In the US -||
2166|068|S|   Call your doctor for medical advice about side effects. You||
2166|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2166|070|S|www.fda.gov/medwatch.||
2166|071|S|   In Canada - Call your doctor for medical advice about side||
2166|072|S|effects. You may report side effects to Health Canada at||
2166|073|S|1-866-234-2345.||
2166|074|B|||
2166|075|P|PRECAUTIONS:  Before taking ubrogepant, tell your doctor or||
2166|076|P|pharmacist if you are allergic to it; or if you have any other||
2166|077|P|allergies. This product may contain inactive ingredients, which||
2166|078|P|can cause allergic reactions or other problems. Talk to your||
2166|079|P|pharmacist for more details.||
2166|080|P|   Before using this medication, tell your doctor or pharmacist||
2166|081|P|your medical history, especially of: blood circulation problems||
2166|082|P|(such as Raynaud's disease), high blood pressure, kidney||
2166|083|P|problems, liver problems.||
2166|084|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
2166|085|P|can make you more drowsy. Do not drive, use machinery, or do||
2166|086|P|anything that needs alertness until you can do it safely. Limit||
2166|087|P|alcoholic beverages. Talk to your doctor if you are using||
2166|088|P|marijuana (cannabis).||
2166|089|P|   Before having surgery, tell your doctor or dentist about all||
2166|090|P|the products you use (including prescription drugs,||
2166|091|P|nonprescription drugs, and herbal products).||
2166|092|P|   During pregnancy, this medication should be used only when||
2166|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
2166|094|P|   This medication passes into breast milk. Consult your doctor||
2166|095|P|before breastfeeding.||
2166|096|B|||
2166|097|I|DRUG INTERACTIONS:  See also How to Use section.||
2166|098|I|   Drug interactions may change how your medications work or||
2166|099|I|increase your risk for serious side effects. This document does||
2166|100|I|not contain all possible drug interactions. Keep a list of all||
2166|101|I|the products you use (including prescription/nonprescription||
2166|102|I|drugs and herbal products) and share it with your doctor and||
2166|103|I|pharmacist. Do not start, stop, or change the dosage of any||
2166|104|I|medicines without your doctor's approval.||
2166|105|I|   Other medications can affect the removal of ubrogepant from||
2166|106|I|your body, which may affect how ubrogepant works. Examples||
2166|107|I|include adagrasib, azole antifungals (such as ketoconazole,||
2166|108|I|itraconazole), cobicistat, macrolide antibiotics (such as||
2166|109|I|clarithromycin, erythromycin), rifamycins (such as rifampin,||
2166|110|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
2166|111|I|seizures (such as carbamazepine, phenytoin), among others.||
2166|112|B|||
2166|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2166|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2166|115|O|poison control center right away. US residents can call||
2166|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2166|117|B|||
2166|118|N|NOTES:  Do not share this medication with others.||
2166|119|N|   Certain foods, beverages, or food additives (such as red wine,||
2166|120|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
2166|121|N|patterns such as irregular eating/sleeping habits or stress may||
2166|122|N|bring on a migraine headache. Avoiding these "triggers" may help||
2166|123|N|lessen migraine attacks. Consult your doctor for more details.||
2166|124|N|   Lab and/or medical tests (such as kidney/liver function, blood||
2166|125|N|pressure) may be done while you are taking this medication. Keep||
2166|126|N|all medical and lab appointments.||
2166|127|B|||
2166|128|D|MISSED DOSE:  Not applicable.||
2166|129|B|||
2166|130|R|STORAGE:  Store at room temperature away from light and moisture.||
2166|131|R|Do not store in the bathroom. Keep all medications away from||
2166|132|R|children and pets.||
2166|133|R|   Do not flush medications down the toilet or pour them into a||
2166|134|R|drain unless instructed to do so. Properly discard this product||
2166|135|R|when it is expired or no longer needed. Consult your pharmacist||
2166|136|R|or local waste disposal company.||
2166|137|B|||
2166|138|A|Information last revised August 2025.||
2166|139|A|Copyright(c) 2025 First Databank, Inc.||
2166|140|B|||
2167|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2167|002|Z|does NOT have all possible information about this product. This||
2167|003|Z|information does not assure that this product is safe, effective,||
2167|004|Z|or appropriate for you. This information is not individual||
2167|005|Z|medical advice and does not substitute for the advice of your||
2167|006|Z|health care professional. Always ask your health care||
2167|007|Z|professional for complete information about this product and your||
2167|008|Z|specific health needs.||
2167|009|B|||
2167|010|T|TEPROTUMUMAB - INJECTION||
2167|011|F|(TEP-roe-TOOM-ue-mab)||
2167|012|B|||
2167|013|C|COMMON BRAND NAME(S): Tepezza||
2167|014|B|||
2167|015|U|USES:  This medication is used to treat thyroid eye disease, also||
2167|016|U|known as Graves' eye disease. Teprotumumab belongs to a class of||
2167|017|U|drugs known as monoclonal antibodies. It is not known exactly how||
2167|018|U|it works, but it may help improve symptoms such as a feeling of||
2167|019|U|irritation or grittiness in the eyes, redness or swelling of the||
2167|020|U|white part of the eyeball (conjunctiva), excessive tearing or dry||
2167|021|U|eyes, swelling of the eyelids, sensitivity to light, bulging of||
2167|022|U|the eyes, or double vision.||
2167|023|B|||
2167|024|H|HOW TO USE:  This medication is given by injection into a vein by||
2167|025|H|a healthcare professional as directed by your doctor, usually||
2167|026|H|every 3 weeks for 8 doses. The injection is usually given over 60||
2167|027|H|to 90 minutes. The dosage is based on your medical condition,||
2167|028|H|weight, and response to treatment.||
2167|029|H|   Use this medication regularly to get the most benefit from it.||
2167|030|H|To help you remember, mark your calendar with a reminder.||
2167|031|H|   Tell your doctor if your condition does not get better or if||
2167|032|H|it gets worse.||
2167|033|B|||
2167|034|S|SIDE EFFECTS:  Muscle spasms, nausea, tiredness, weakness, change||
2167|035|S|in how food tastes, or dry skin may occur. If any of these||
2167|036|S|effects last or get worse, tell your doctor or pharmacist||
2167|037|S|promptly.||
2167|038|S|   Injection reaction symptoms such as increased blood pressure,||
2167|039|S|fast heartbeat, feeling hot, headache, and muscle pain may also||
2167|040|S|occur. Tell your doctor right away if you have any of these||
2167|041|S|symptoms. Your doctor may direct you to take other medications||
2167|042|S|(such as acetaminophen, antihistamines) before each dose to||
2167|043|S|decrease the risk of side effects.||
2167|044|S|   Temporary hair loss may occur. Normal hair growth should||
2167|045|S|return after treatment has ended.||
2167|046|S|   Remember that this medication has been prescribed because your||
2167|047|S|doctor has judged that the benefit to you is greater than the||
2167|048|S|risk of side effects. Many people using this medication do not||
2167|049|S|have serious side effects.||
2167|050|S|   Tell your doctor right away if you have any serious side||
2167|051|S|effects, including: bowel problems (such as diarrhea, bloody||
2167|052|S|stools, abdominal pain/cramps, or incontinence), hearing problems||
2167|053|S|(such as ringing in the ears, hearing loss), menstrual period||
2167|054|S|changes (such as missed/stopped periods, spotting).||
2167|055|S|   This medication may rarely make your blood sugar rise, which||
2167|056|S|can cause or worsen diabetes. Tell your doctor right away if you||
2167|057|S|have symptoms of high blood sugar, such as increased||
2167|058|S|thirst/urination. If you already have diabetes, check your blood||
2167|059|S|sugar regularly as directed and share the results with your||
2167|060|S|doctor. Your doctor may need to adjust your diabetes medication,||
2167|061|S|exercise program, or diet.||
2167|062|S|   A very serious allergic reaction to this drug is rare.||
2167|063|S|However, get medical help right away if you notice any symptoms||
2167|064|S|of a serious allergic reaction, including: rash, itching/swelling||
2167|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2167|066|S|breathing.||
2167|067|S|   This is not a complete list of possible side effects. If you||
2167|068|S|notice other effects not listed above, contact your doctor or||
2167|069|S|pharmacist.||
2167|070|S|   In the US -||
2167|071|S|   Call your doctor for medical advice about side effects. You||
2167|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2167|073|S|www.fda.gov/medwatch.||
2167|074|S|   In Canada - Call your doctor for medical advice about side||
2167|075|S|effects. You may report side effects to Health Canada at||
2167|076|S|1-866-234-2345.||
2167|077|B|||
2167|078|P|PRECAUTIONS:  Before using teprotumumab, tell your doctor or||
2167|079|P|pharmacist if you are allergic to it; or if you have any other||
2167|080|P|allergies. This product may contain inactive ingredients, which||
2167|081|P|can cause allergic reactions or other problems. Talk to your||
2167|082|P|pharmacist for more details.||
2167|083|P|   Before using this medication, tell your doctor or pharmacist||
2167|084|P|your medical history, especially of: bowel problems (such as||
2167|085|P|inflammatory bowel disease-IBD), diabetes.||
2167|086|P|   Before having surgery, tell your doctor or dentist about all||
2167|087|P|the products you use (including prescription drugs,||
2167|088|P|nonprescription drugs, and herbal products).||
2167|089|P|   Tell your doctor if you are pregnant or plan to become||
2167|090|P|pregnant. You should not become pregnant while using||
2167|091|P|teprotumumab. Teprotumumab may harm an unborn baby. Your doctor||
2167|092|P|should order a pregnancy test before you start this medication.||
2167|093|P|Ask about reliable forms of birth control before and while using||
2167|094|P|this medication and for 6 months after the last dose. If you||
2167|095|P|become pregnant, talk to your doctor right away about the risks||
2167|096|P|and benefits of this medication.||
2167|097|P|   It is unknown if this medication passes into breast milk.||
2167|098|P|Consult your doctor before breastfeeding.||
2167|099|B|||
2167|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2167|101|I|medications work or increase your risk for serious side effects.||
2167|102|I|This document does not contain all possible drug interactions.||
2167|103|I|Keep a list of all the products you use (including||
2167|104|I|prescription/nonprescription drugs and herbal products) and share||
2167|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
2167|106|I|the dosage of any medicines without your doctor's approval.||
2167|107|B|||
2167|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2167|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2167|110|O|poison control center right away. US residents can call||
2167|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2167|112|B|||
2167|113|N|NOTES:  Do not share this medication with others.||
2167|114|N|   Lab and/or medical tests (such as eye exams, hearing tests,||
2167|115|N|blood sugar) may be done before you start using this medication||
2167|116|N|and while you are using it. Keep all medical and lab||
2167|117|N|appointments.||
2167|118|B|||
2167|119|D|MISSED DOSE:  It is important to get each dose of this medication||
2167|120|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2167|121|D|right away for a new dosing schedule.||
2167|122|B|||
2167|123|R|STORAGE:  Not applicable. This medication is given in a hospital||
2167|124|R|or clinic or doctor's office and will not be stored at home.||
2167|125|B|||
2167|126|A|Information last revised September 2025.||
2167|127|A|Copyright(c) 2025 First Databank, Inc.||
2167|128|B|||
2170|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2170|002|Z|does NOT have all possible information about this product. This||
2170|003|Z|information does not assure that this product is safe, effective,||
2170|004|Z|or appropriate for you. This information is not individual||
2170|005|Z|medical advice and does not substitute for the advice of your||
2170|006|Z|health care professional. Always ask your health care||
2170|007|Z|professional for complete information about this product and your||
2170|008|Z|specific health needs.||
2170|009|B|||
2170|010|T|PRAMOXINE/HYDROCORTISONE CREAM, OINTMENT - RECTAL||
2170|011|F|(pram-OX-een/hi-dro-KOR-tih-sown)||
2170|012|B|||
2170|013|C|COMMON BRAND NAME(S): Analpram||
2170|014|B|||
2170|015|U|USES:  This combination medication is used to treat minor pain,||
2170|016|U|itching, swelling, and discomfort caused by hemorrhoids and other||
2170|017|U|problems of the anal area (such as anal fissures, itching). This||
2170|018|U|medication contains pramoxine, an anesthetic that works by||
2170|019|U|temporarily numbing the area. This product also contains||
2170|020|U|hydrocortisone, a corticosteroid that reduces redness, itching,||
2170|021|U|and swelling.||
2170|022|B|||
2170|023|H|HOW TO USE:  Before use, clean the affected area with mild soap||
2170|024|H|and water, rinse well, and pat dry.||
2170|025|H|   To apply this product inside the anus, use the applicator||
2170|026|H|tip/cap/nozzle, following all instructions in the product||
2170|027|H|package, or use as directed by your doctor. Fill the applicator||
2170|028|H|with medication from the container as directed. Gently insert the||
2170|029|H|applicator tip just 1/2 to 1 inch (1.5 to 2.5 centimeters) inside||
2170|030|H|the anus and apply in and around the anal opening as directed. Do||
2170|031|H|not insert your finger or any part of the container into the||
2170|032|H|anus, and do not insert the applicator tip/nozzle more than 1/2||
2170|033|H|to 1 inch (1.5 to 2.5 centimeters) inside the anus. Do not use||
2170|034|H|your finger to apply this medication inside the anus. If you are||
2170|035|H|using a single-use tube and applicator, discard after one use.||
2170|036|H|   To apply the product to the outside of the anus only, apply a||
2170|037|H|small amount to the affected area and rub in gently.||
2170|038|H|   Do not cover the area with plastic or waterproof bandages||
2170|039|H|unless directed to do so by your doctor. Covering the treated||
2170|040|H|area may increase the absorption of the medication through the||
2170|041|H|skin. This may improve how well the drug works, but it may also||
2170|042|H|increase the risk of side effects.||
2170|043|H|   Wash hands immediately after use. Avoid getting the product in||
2170|044|H|your eyes, nose, ears or mouth. If the medication gets in these||
2170|045|H|areas, rinse the area immediately with clean water.||
2170|046|H|   Some brands are packaged in kits which have wipes. Before||
2170|047|H|applying this medication, use the wipes as directed. The wipes||
2170|048|H|are usually flushable, so discard the used wipes in the toilet.||
2170|049|H|   This product is used as directed by your doctor, usually 3 to||
2170|050|H|4 times daily, or after each bowel movement. The dosage is based||
2170|051|H|on your medical condition and response to treatment. Use this||
2170|052|H|medication regularly in order to get the most benefit from it. To||
2170|053|H|help you remember, use it at the same times each day.||
2170|054|H|   Do not use more of this product, use it more often, or keep||
2170|055|H|using it longer than prescribed by your doctor. If you have been||
2170|056|H|using this medication for a long time or in high doses, do not||
2170|057|H|suddenly stop using it without your doctor's approval. Some||
2170|058|H|conditions may become worse when this drug is suddenly stopped.||
2170|059|H|Your dose may need to be gradually decreased.||
2170|060|H|   Tell your doctor if your condition does not get better or if||
2170|061|H|it gets worse after 1 to 2 weeks.||
2170|062|B|||
2170|063|S|SIDE EFFECTS:  Redness, burning, or itching at the application||
2170|064|S|site may occur. If any of these effects last or get worse,||
2170|065|S|contact your doctor or pharmacist promptly.||
2170|066|S|   Remember that this medication has been prescribed because your||
2170|067|S|doctor has judged that the benefit to you is greater than the||
2170|068|S|risk of side effects. Many people using this medication do not||
2170|069|S|have serious side effects.||
2170|070|S|   Tell your doctor right away if you have any serious side||
2170|071|S|effects, including: rectal bleeding, change in skin appearance||
2170|072|S|(such as color, thickness), skin redness/tenderness/pus, signs of||
2170|073|S|infection (such as sore throat that doesn't go away, fever,||
2170|074|S|chills).||
2170|075|S|   Rarely, it is possible this medication will be absorbed into||
2170|076|S|the bloodstream. This can lead to side effects of too much||
2170|077|S|corticosteroid. These side effects are more likely in children||
2170|078|S|and people who use this medication for a long time. Tell your||
2170|079|S|doctor right away if any of the following side effects occur:||
2170|080|S|unusual/extreme tiredness, weight loss, headache, swelling||
2170|081|S|ankles/feet, increased thirst/urination, vision problems.||
2170|082|S|   A very serious allergic reaction to this drug is rare.||
2170|083|S|However, get medical help right away if you notice any symptoms||
2170|084|S|of a serious allergic reaction, including: rash, itching/swelling||
2170|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2170|086|S|breathing.||
2170|087|S|   This is not a complete list of possible side effects. If you||
2170|088|S|notice other effects not listed above, contact your doctor or||
2170|089|S|pharmacist.||
2170|090|S|   In the US -||
2170|091|S|   Call your doctor for medical advice about side effects. You||
2170|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2170|093|S|www.fda.gov/medwatch.||
2170|094|S|   In Canada - Call your doctor for medical advice about side||
2170|095|S|effects. You may report side effects to Health Canada at||
2170|096|S|1-866-234-2345.||
2170|097|B|||
2170|098|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2170|099|P|pharmacist if you are allergic to pramoxine; or to||
2170|100|P|hydrocortisone; or if you have any other allergies. This product||
2170|101|P|may contain inactive ingredients, which can cause allergic||
2170|102|P|reactions or other problems. Talk to your pharmacist for more||
2170|103|P|details.||
2170|104|P|   Before using this medication, tell your doctor or pharmacist||
2170|105|P|your medical history, especially of: diabetes, eye problems,||
2170|106|P|infections (especially rectal sores/infections), liver disease,||
2170|107|P|stomach/intestinal problems.||
2170|108|P|   Rarely, using corticosteroid medications for a long time can||
2170|109|P|make it more difficult for your body to respond to physical||
2170|110|P|stress. Before having surgery or emergency treatment, or if you||
2170|111|P|get a serious illness/injury, tell your doctor or dentist that||
2170|112|P|you are using this medication or have used this medication within||
2170|113|P|the past few months.||
2170|114|P|   Though it is unlikely, this medication may temporarily slow||
2170|115|P|down a child's growth if used for a long time. See the doctor||
2170|116|P|regularly so your child's height can be checked.||
2170|117|P|   During pregnancy, this medication should be used only when||
2170|118|P|clearly needed. It should not be used for long periods of time or||
2170|119|P|in large amounts. Discuss the risks and benefits with your||
2170|120|P|doctor.||
2170|121|P|   It is unknown if this medication passes into breast milk.||
2170|122|P|Consult your doctor before breastfeeding.||
2170|123|B|||
2170|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2170|125|I|medications work or increase your risk for serious side effects.||
2170|126|I|This document does not contain all possible drug interactions.||
2170|127|I|Keep a list of all the products you use (including||
2170|128|I|prescription/nonprescription drugs and herbal products) and share||
2170|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
2170|130|I|the dosage of any medicines without your doctor's approval.||
2170|131|I|   A product that may interact with this drug is: desmopressin.||
2170|132|B|||
2170|133|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2170|134|O|has overdosed and has serious symptoms such as passing out or||
2170|135|O|trouble breathing, call 911. Otherwise, call a poison control||
2170|136|O|center right away. US residents can call 1-800-222-1222. Canada||
2170|137|O|residents can call 1-844-764-7669.||
2170|138|B|||
2170|139|N|NOTES:  Do not share this medication with others.||
2170|140|N|   Lab and/or medical tests (such as cortisol levels) may be done||
2170|141|N|while you are using this medication. Keep all medical and lab||
2170|142|N|appointments. Consult your doctor for more details.||
2170|143|N|   This medication has been prescribed for your current condition||
2170|144|N|only. Do not use it later for another condition unless told to do||
2170|145|N|so by your doctor. A different medication may be necessary in||
2170|146|N|that case.||
2170|147|B|||
2170|148|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
2170|149|D|unless it is almost time for the next dose. In that case, skip||
2170|150|D|the missed dose. Use your next dose at the regular time. Do not||
2170|151|D|double the dose to catch up.||
2170|152|B|||
2170|153|R|STORAGE:  Store at room temperature away from light and moisture.||
2170|154|R|Do not refrigerate. Keep all medications away from children and||
2170|155|R|pets.||
2170|156|R|   Do not flush medications down the toilet or pour them into a||
2170|157|R|drain unless instructed to do so. Properly discard this product||
2170|158|R|when it is expired or no longer needed. Consult your pharmacist||
2170|159|R|or local waste disposal company.||
2170|160|B|||
2170|161|A|Information last revised May 2025.||
2170|162|A|Copyright(c) 2025 First Databank, Inc.||
2170|163|B|||
2171|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2171|002|Z|does NOT have all possible information about this product. This||
2171|003|Z|information does not assure that this product is safe, effective,||
2171|004|Z|or appropriate for you. This information is not individual||
2171|005|Z|medical advice and does not substitute for the advice of your||
2171|006|Z|health care professional. Always ask your health care||
2171|007|Z|professional for complete information about this product and your||
2171|008|Z|specific health needs.||
2171|009|B|||
2171|010|T|FLUMETHASONE/CLIOQUINOL SOLUTION - OTIC||
2171|011|F|(flew-METH-uh-sown/klye-oh-KWIN-ohl)||
2171|012|B|||
2171|013|U|USES:  This medication is used to treat certain types of outer||
2171|014|U|ear infections. It helps to reduce swelling, itching, redness,||
2171|015|U|and discomfort in the ear. This ear drop contains both||
2171|016|U|flumethasone, an anti-inflammatory corticosteroid, and||
2171|017|U|clioquinol, an antibiotic that stops the growth of certain||
2171|018|U|bacteria and fungi.||
2171|019|U|   This medication treats only certain types of bacterial and||
2171|020|U|fungal ear infections. It will not work for other types of ear||
2171|021|U|infections. Unnecessary use or overuse of any antibiotic can lead||
2171|022|U|to its decreased effectiveness.||
2171|023|U|   This medication should not be used by children younger than 2||
2171|024|U|years.||
2171|025|B|||
2171|026|H|HOW TO USE:  This medication is for use only in the ear. For best||
2171|027|H|results, the ear canal should be clean and dry before using this||
2171|028|H|medication. Ask your doctor for instructions on how to properly||
2171|029|H|clean the ear and how to use an ear syringe with a soft rubber||
2171|030|H|bulb if needed.||
2171|031|H|   Apply this medication into the ear as directed by your doctor,||
2171|032|H|usually twice daily. Do not use this medication more often or for||
2171|033|H|longer than prescribed. The length of treatment is usually not||
2171|034|H|more than 10 days.||
2171|035|H|   To make sure that the right amount of medication is given, and||
2171|036|H|to avoid touching the ear with the dropper, have another person||
2171|037|H|give the drops if possible. To lower the risk of dizziness, hold||
2171|038|H|the container in your hand for a few minutes to warm it.||
2171|039|H|   To apply ear drops, wash your hands first. To avoid||
2171|040|H|contamination, do not touch the dropper tip or let it touch your||
2171|041|H|ear or any other surface. Lie on your side or tilt the affected||
2171|042|H|ear upward. Hold the dropper directly over the ear and place the||
2171|043|H|prescribed number of drops into the ear canal. To help the drops||
2171|044|H|roll into the ear of an adult, hold the earlobe up and back. In||
2171|045|H|children, hold the earlobe down and back. Keep the head tilted||
2171|046|H|for about 2 minutes, or insert a soft cotton plug in the ear if||
2171|047|H|so directed. Repeat for the other ear if so directed. Do not||
2171|048|H|rinse the dropper. Replace the cap after use.||
2171|049|H|   Use this medication regularly to get the most benefit from it.||
2171|050|H|To help you remember, use it at the same times each day. Continue||
2171|051|H|to use this medication for the full time prescribed, even if||
2171|052|H|symptoms disappear after a few days. Stopping the medication too||
2171|053|H|early may result in a return of the infection.||
2171|054|H|   Do not use in the eye.||
2171|055|H|   Tell your doctor if your condition does not get better within||
2171|056|H|1 week or if it gets worse.||
2171|057|B|||
2171|058|S|SIDE EFFECTS:  A temporary stinging or burning feeling in the ear||
2171|059|S|may occur for 1 to 2 minutes when this medication is applied. If||
2171|060|S|this effect lasts or gets worse, tell your doctor or pharmacist||
2171|061|S|promptly.||
2171|062|S|   Remember that this medication has been prescribed because your||
2171|063|S|doctor has judged that the benefit to you is greater than the||
2171|064|S|risk of side effects. Many people using this medication do not||
2171|065|S|have serious side effects.||
2171|066|S|   A very serious allergic reaction to this drug is rare.||
2171|067|S|However, get medical help right away if you notice any symptoms||
2171|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2171|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2171|070|S|breathing.||
2171|071|S|   This is not a complete list of possible side effects. If you||
2171|072|S|notice other effects not listed above, contact your doctor or||
2171|073|S|pharmacist.||
2171|074|S|   In the US -||
2171|075|S|   Call your doctor for medical advice about side effects. You||
2171|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2171|077|S|www.fda.gov/medwatch.||
2171|078|S|   In Canada - Call your doctor for medical advice about side||
2171|079|S|effects. You may report side effects to Health Canada at||
2171|080|S|1-866-234-2345.||
2171|081|B|||
2171|082|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2171|083|P|pharmacist if you are allergic to flumethasone or other||
2171|084|P|corticosteroids (such as prednisone); or to clioquinol or related||
2171|085|P|antibiotic/anti-fungal drugs (such as iodoquinol); or to iodine;||
2171|086|P|or if you have any other allergies. This product may contain||
2171|087|P|inactive ingredients, which can cause allergic reactions or other||
2171|088|P|problems. Talk to your pharmacist for more details.||
2171|089|P|   Before using this medication, tell your doctor or pharmacist||
2171|090|P|your medical history, especially of: a hole/perforation in the||
2171|091|P|eardrum, skin reactions/infections (for example, those caused by||
2171|092|P|vaccines, tuberculosis, syphilis, viruses such as chickenpox or||
2171|093|P|herpes).||
2171|094|P|   This medication may stain clothes, skin, nails, or hair.||
2171|095|P|   During pregnancy, this medication should be used only when||
2171|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
2171|097|P|   It is unknown if this drug passes into breast milk. Consult||
2171|098|P|your doctor before breastfeeding.||
2171|099|B|||
2171|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2171|101|I|medications work or increase your risk for serious side effects.||
2171|102|I|This document does not contain all possible drug interactions.||
2171|103|I|Keep a list of all the products you use (including||
2171|104|I|prescription/nonprescription drugs and herbal products) and share||
2171|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
2171|106|I|the dosage of any medicines without your doctor's approval.||
2171|107|I|   Clioquinol may interfere with certain lab tests (such as||
2171|108|I|thyroid tests), possibly causing false test results. Make sure||
2171|109|I|lab personnel and all your doctors know you use this drug.||
2171|110|B|||
2171|111|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2171|112|O|has overdosed and has serious symptoms such as passing out or||
2171|113|O|trouble breathing, call 911. Otherwise, call a poison control||
2171|114|O|center right away. US residents can call 1-800-222-1222. Canada||
2171|115|O|residents can call 1-844-764-7669.||
2171|116|B|||
2171|117|N|NOTES:  Do not share this medication with others.||
2171|118|N|   This medication has been prescribed for your current condition||
2171|119|N|only. Do not use it later for another infection unless your||
2171|120|N|doctor tells you to.||
2171|121|N|   It is important to keep the infected ear(s) clean and dry. Try||
2171|122|N|not to get the infected ear(s) wet when bathing. Avoid swimming||
2171|123|N|unless your doctor tells you otherwise.||
2171|124|B|||
2171|125|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2171|126|D|If it is near the time of the next dose, skip the missed dose.||
2171|127|D|Use your next dose at the regular time. Do not double the dose to||
2171|128|D|catch up.||
2171|129|B|||
2171|130|R|STORAGE:  Store at room temperature. The solution may turn yellow||
2171|131|R|when it is exposed to air, but it is still safe to use. It may||
2171|132|R|stain hair, skin, and clothing. Keep all medications away from||
2171|133|R|children and pets.||
2171|134|R|   Do not flush medications down the toilet or pour them into a||
2171|135|R|drain unless instructed to do so. Properly discard this product||
2171|136|R|when it is expired or no longer needed. Consult your pharmacist||
2171|137|R|or local waste disposal company.||
2171|138|B|||
2171|139|A|Information last revised November 2024.||
2171|140|A|Copyright(c) 2025 First Databank, Inc.||
2171|141|B|||
2172|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2172|002|Z|does NOT have all possible information about this product. This||
2172|003|Z|information does not assure that this product is safe, effective,||
2172|004|Z|or appropriate for you. This information is not individual||
2172|005|Z|medical advice and does not substitute for the advice of your||
2172|006|Z|health care professional. Always ask your health care||
2172|007|Z|professional for complete information about this product and your||
2172|008|Z|specific health needs.||
2172|009|B|||
2172|010|T|DECONGESTANT/ANTIHISTAMINE/ANTICHOLINERGIC - ORAL||
2172|011|B|||
2172|012|U|USES:  This medication is used for the temporary relief of||
2172|013|U|runny/stuffy nose, watery/itchy eyes, and itchy throat caused by||
2172|014|U|allergies, hay fever, the common cold, and other breathing||
2172|015|U|illnesses. This product is usually not used for ongoing cough||
2172|016|U|from smoking or long-term breathing problems (such as chronic||
2172|017|U|bronchitis, emphysema) unless directed by your doctor. The||
2172|018|U|decongestant treats nasal congestion by narrowing the blood||
2172|019|U|vessels in the nose. The antihistamine relieves itchy/watery eyes||
2172|020|U|and itchy throat by blocking a substance (histamine) released by||
2172|021|U|allergies. The anticholinergic dries up a runny nose and the||
2172|022|U|fluid that runs down your throat causing itching/irritation.||
2172|023|U|   Cough-and-cold products have not been shown to be safe or||
2172|024|U|effective in children younger than 6 years. Do not use this||
2172|025|U|product to treat cold symptoms in children younger than 6 years||
2172|026|U|unless specifically directed by the doctor. Some products (such||
2172|027|U|as long-acting tablets/capsules) are not recommended for use in||
2172|028|U|children younger than 12 years. Ask your doctor or pharmacist for||
2172|029|U|more details about using your product safely.||
2172|030|U|   These products do not cure or shorten the length of the common||
2172|031|U|cold and may cause serious side effects. To decrease the risk for||
2172|032|U|serious side effects, carefully follow all dosage directions. Do||
2172|033|U|not use this product to make a child sleepy. Do not give other||
2172|034|U|cough-and-cold medication that might contain the same or similar||
2172|035|U|ingredients (see also Drug Interactions section). Ask the doctor||
2172|036|U|or pharmacist about other ways to relieve cough and cold symptoms||
2172|037|U|(such as drinking enough fluids, using a humidifier or saline||
2172|038|U|nose drops/spray).||
2172|039|B|||
2172|040|H|HOW TO USE:  Take this medication by mouth with a full glass of||
2172|041|H|water unless otherwise directed by your doctor. Carefully follow||
2172|042|H|your doctor's directions for taking this medication. This||
2172|043|H|medication may be taken with food or milk if stomach upset||
2172|044|H|occurs. To prevent trouble sleeping, do not take this medication||
2172|045|H|close to bedtime. If you have any questions, ask your doctor or||
2172|046|H|pharmacist.||
2172|047|H|   The dosage is based on the product you are taking and on your||
2172|048|H|age, medical condition, and response to treatment. Do not||
2172|049|H|increase your dose or take this drug more often than directed.||
2172|050|H|   If you are using a liquid form, carefully measure your||
2172|051|H|prescribed dose using a medication-measuring device or spoon. Do||
2172|052|H|not use a household spoon because you may not get the correct||
2172|053|H|dose. If your liquid form is a suspension, shake the bottle well||
2172|054|H|before each dose.||
2172|055|H|   Swallow extended-release capsules whole. Do not crush or chew||
2172|056|H|extended-release capsules or tablets. Doing so can release all of||
2172|057|H|the drug at once, increasing the risk of side effects. Also, do||
2172|058|H|not split extended-release tablets unless they have a score line||
2172|059|H|and your doctor or pharmacist tells you to do so. Swallow the||
2172|060|H|whole or split tablet without crushing or chewing.||
2172|061|H|   Chewable forms of this medication should be chewed thoroughly||
2172|062|H|before swallowing.||
2172|063|H|   Caffeine can increase the side effects of this medication.||
2172|064|H|Avoid drinking large amounts of beverages containing caffeine||
2172|065|H|(coffee, tea, colas), eating large amounts of chocolate, or||
2172|066|H|taking nonprescription products that contain caffeine.||
2172|067|H|   Tell your doctor if your condition occurs with a headache that||
2172|068|H|doesn't go away, fever, severe sore throat, rash, or if it lasts,||
2172|069|H|returns, or gets worse after 7 days. These may be signs of a||
2172|070|H|serious medical problem.||
2172|071|B|||
2172|072|S|SIDE EFFECTS:  Drowsiness, dizziness, dry mouth, blurred vision,||
2172|073|S|headache, stomach upset, and constipation may occur. If any of||
2172|074|S|these effects last or get worse, tell your doctor or pharmacist||
2172|075|S|promptly.||
2172|076|S|   Remember that this medication has been prescribed because your||
2172|077|S|doctor has judged that the benefit to you is greater than the||
2172|078|S|risk of side effects. Many people using this medication do not||
2172|079|S|have serious side effects.||
2172|080|S|   This medication may raise your blood pressure. Check your||
2172|081|S|blood pressure regularly and tell your doctor if the results are||
2172|082|S|high.||
2172|083|S|   Tell your doctor right away if you have any serious side||
2172|084|S|effects, including: fast heartbeat, mental/mood changes (such as||
2172|085|S|nervousness, excitement, irritability), trouble sleeping, shaking||
2172|086|S|(tremors), difficult/painful urination.||
2172|087|S|   Get medical help right away if you have any very serious side||
2172|088|S|effects, including: fainting, very fast/pounding/irregular||
2172|089|S|heartbeat, severe mental/mood changes (such as confusion,||
2172|090|S|hallucinations), seizures, eye pain/swelling/redness, vision||
2172|091|S|changes (such as seeing rainbows around lights at night).||
2172|092|S|   A very serious allergic reaction to this drug is rare.||
2172|093|S|However, get medical help right away if you notice any symptoms||
2172|094|S|of a serious allergic reaction, including: rash, itching/swelling||
2172|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2172|096|S|breathing.||
2172|097|S|   This is not a complete list of possible side effects. If you||
2172|098|S|notice other effects not listed above, contact your doctor or||
2172|099|S|pharmacist.||
2172|100|S|   In the US -||
2172|101|S|   Call your doctor for medical advice about side effects. You||
2172|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2172|103|S|www.fda.gov/medwatch.||
2172|104|S|   In Canada - Call your doctor for medical advice about side||
2172|105|S|effects. You may report side effects to Health Canada at||
2172|106|S|1-866-234-2345.||
2172|107|B|||
2172|108|P|PRECAUTIONS:  Before taking||
2172|109|P|decongestant/antihistamine/anticholinergic combination||
2172|110|P|medications, tell your doctor or pharmacist if you are allergic||
2172|111|P|to any of the ingredients; or if you have any other allergies.||
2172|112|P|Also tell your doctor if you have had a bad reaction to||
2172|113|P|decongestants (such as ephedrine, phenylephrine,||
2172|114|P|pseudoephedrine). This product may contain inactive ingredients,||
2172|115|P|which can cause allergic reactions or other problems. Talk to||
2172|116|P|your pharmacist for more details.||
2172|117|P|   Before using this medication, tell your doctor or pharmacist||
2172|118|P|your medical history, especially of: asthma, high blood pressure,||
2172|119|P|heart disease (such as chest pain, heart failure, heart attack),||
2172|120|P|fast/slow/irregular heartbeat, diabetes, personal or family||
2172|121|P|history of glaucoma (angle-closure type), seizures,||
2172|122|P|stomach/intestinal ulcer, kidney problems, difficulty urinating||
2172|123|P|(such as due to enlarged prostate, urinary retention), overactive||
2172|124|P|thyroid (hyperthyroidism).||
2172|125|P|   This drug may make you dizzy or drowsy or blur your vision.||
2172|126|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
2172|127|P|drowsy. Do not drive, use machinery, or do anything that needs||
2172|128|P|alertness or clear vision until you can do it safely. Avoid||
2172|129|P|alcoholic beverages. Talk to your doctor if you are using||
2172|130|P|marijuana (cannabis).||
2172|131|P|   Liquid and chewable forms of this product may contain sugar,||
2172|132|P|alcohol, or aspartame. Caution is advised if you have diabetes,||
2172|133|P|liver disease, phenylketonuria (PKU), or any other condition that||
2172|134|P|requires you to limit/avoid these substances in your diet. Ask||
2172|135|P|your doctor or pharmacist about using this product safely.||
2172|136|P|   This medication may make you sweat less, making you more||
2172|137|P|likely to get heat stroke. Avoid doing things that may cause you||
2172|138|P|to overheat, such as hard work or exercise in hot weather, or||
2172|139|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2172|140|P|and dress lightly. If you overheat, quickly look for a place to||
2172|141|P|cool down and rest. Get medical help right away if you have a||
2172|142|P|fever that does not go away, mental/mood changes, headache, or||
2172|143|P|dizziness.||
2172|144|P|   Before having surgery, tell your doctor or dentist about all||
2172|145|P|the products you use (including prescription drugs,||
2172|146|P|nonprescription drugs, and herbal products).||
2172|147|P|   Older adults may be more sensitive to the side effects of this||
2172|148|P|drug, especially fast/irregular heartbeat, dizziness, drowsiness,||
2172|149|P|problems urinating, trouble sleeping, constipation, or confusion.||
2172|150|P|Dizziness, drowsiness, trouble sleeping and confusion can||
2172|151|P|increase the risk of falling.||
2172|152|P|   Children may be more sensitive to the side effects of this||
2172|153|P|drug, especially excitation, nervousness, or increased blood||
2172|154|P|pressure.||
2172|155|P|   During pregnancy, this medication should be used only when||
2172|156|P|clearly needed. Discuss the risks and benefits with your doctor.||
2172|157|P|   Some ingredients in this product may pass into breast milk.||
2172|158|P|Consult your doctor before breastfeeding.||
2172|159|B|||
2172|160|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2172|161|I|medications work or increase your risk for serious side effects.||
2172|162|I|This document does not contain all possible drug interactions.||
2172|163|I|Keep a list of all the products you use (including||
2172|164|I|prescription/nonprescription drugs and herbal products) and share||
2172|165|I|it with your doctor and pharmacist. Do not start, stop, or change||
2172|166|I|the dosage of any medicines without your doctor's approval.||
2172|167|I|   Some drugs that may interact with this product are:||
2172|168|I|antihistamines applied to the skin (such as diphenhydramine||
2172|169|I|cream, ointment, spray), digoxin, potassium tablets/capsules,||
2172|170|I|pramlintide.||
2172|171|I|   Taking MAO inhibitors with this medication may cause a serious||
2172|172|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2172|173|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2172|174|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2172|175|I|selegiline, tranylcypromine) during treatment with this||
2172|176|I|medication. Most MAO inhibitors should also not be taken for two||
2172|177|I|weeks before treatment with this medication. Ask your doctor when||
2172|178|I|to start or stop taking this medication.||
2172|179|I|   Tell your doctor or pharmacist if you are taking other||
2172|180|I|products that cause drowsiness such as opioid pain or cough||
2172|181|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2172|182|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2172|183|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2172|184|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
2172|185|I|diphenhydramine).||
2172|186|I|   Check the labels on all your medicines (such as allergy or||
2172|187|I|cough-and-cold products) because they may contain ingredients||
2172|188|I|that cause drowsiness. Ask your pharmacist about using those||
2172|189|I|products safely.||
2172|190|I|   Decongestants and antihistamines are available in both||
2172|191|I|prescription and nonprescription products. Check the labels of||
2172|192|I|all your medications carefully to make sure you are not taking||
2172|193|I|more than one product containing these medications.||
2172|194|I|   This medication may interfere with certain medical/lab tests||
2172|195|I|(such as brain scan for Parkinson's disease, allergy skin test),||
2172|196|I|possibly causing false test results. Make sure lab personnel and||
2172|197|I|all your doctors know you use this drug.||
2172|198|B|||
2172|199|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2172|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2172|201|O|poison control center right away. US residents can call||
2172|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2172|203|O|Symptoms of overdose may include: irregular heartbeat, vomiting,||
2172|204|O|hallucinations, hot/dry skin, fainting, inability to wake up||
2172|205|O|(coma), seizures.||
2172|206|B|||
2172|207|N|NOTES:  Do not share this medication with others.||
2172|208|N|   This medication is usually for temporary use only. Do not take||
2172|209|N|this medication for more than 7 days unless your doctor tells you||
2172|210|N|to do so. Tell your doctor if your condition lasts longer than 7||
2172|211|N|days.||
2172|212|B|||
2172|213|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2172|214|D|remember. If it is near the time of the next dose, skip the||
2172|215|D|missed dose. Take your next dose at the regular time. Do not||
2172|216|D|double the dose to catch up.||
2172|217|B|||
2172|218|R|STORAGE:  Store at room temperature away from light and moisture.||
2172|219|R|Do not store in the bathroom. Do not freeze liquid forms of this||
2172|220|R|medication. Different brands of this medication have different||
2172|221|R|storage needs. Check the product package for instructions on how||
2172|222|R|to store your brand, or ask your pharmacist. Keep all medications||
2172|223|R|away from children and pets.||
2172|224|R|   Do not flush medications down the toilet or pour them into a||
2172|225|R|drain unless instructed to do so. Properly discard this product||
2172|226|R|when it is expired or no longer needed. Consult your pharmacist||
2172|227|R|or local waste disposal company.||
2172|228|B|||
2172|229|A|Information last revised July 2025.||
2172|230|A|Copyright(c) 2025 First Databank, Inc.||
2172|231|B|||
2175|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2175|002|Z|does NOT have all possible information about this product. This||
2175|003|Z|information does not assure that this product is safe, effective,||
2175|004|Z|or appropriate for you. This information is not individual||
2175|005|Z|medical advice and does not substitute for the advice of your||
2175|006|Z|health care professional. Always ask your health care||
2175|007|Z|professional for complete information about this product and your||
2175|008|Z|specific health needs.||
2175|009|B|||
2175|010|T|LASMIDITAN - ORAL||
2175|011|F|(las-MID-i-tan)||
2175|012|B|||
2175|013|C|COMMON BRAND NAME(S): Reyvow||
2175|014|B|||
2175|015|U|USES:  Lasmiditan is used to treat migraines. It helps to relieve||
2175|016|U|headache, pain, and other migraine symptoms (including nausea,||
2175|017|U|vomiting, sensitivity to light/sound). Prompt treatment helps you||
2175|018|U|return to your normal routine and may decrease your need for||
2175|019|U|other pain medications. Lasmiditan belongs to a class of drugs||
2175|020|U|known as ditans. It affects a certain natural substance||
2175|021|U|(serotonin) that causes narrowing of blood vessels in the brain.||
2175|022|U|   Lasmiditan does not prevent future migraines or lessen how||
2175|023|U|often you get migraine attacks.||
2175|024|B|||
2175|025|H|HOW TO USE:  Read the Medication Guide provided by your||
2175|026|H|pharmacist before you start taking lasmiditan and each time you||
2175|027|H|get a refill. If you have any questions, ask your doctor or||
2175|028|H|pharmacist.||
2175|029|H|   Take this medication by mouth with or without food as directed||
2175|030|H|by your doctor, usually at the first sign of a migraine. Swallow||
2175|031|H|the tablets whole. Do not split, crush, or chew the tablets.||
2175|032|H|Doing so may increase the risk of side effects. The dosage is||
2175|033|H|based on your medical condition and response to treatment. Do not||
2175|034|H|take more than one dose of this medication in a 24-hour period.||
2175|035|H|Tell your doctor right away if your symptoms do not get better or||
2175|036|H|if they get worse. Do not drive, use machinery, or do anything||
2175|037|H|that needs alertness for at least 8 hours after taking this||
2175|038|H|medication.||
2175|039|H|   Rarely, abnormal drug-seeking behavior (drug abuse) is||
2175|040|H|possible with this medication. Do not increase your dose or use||
2175|041|H|it more often than prescribed. Properly stop the medication when||
2175|042|H|so directed.||
2175|043|H|   If you are using drugs for migraine attacks on 10 or more days||
2175|044|H|each month, the drugs may actually make your headaches worse||
2175|045|H|(medication overuse headache). Do not use medications more often||
2175|046|H|or for longer than directed. Tell your doctor if you need to use||
2175|047|H|this medication more often, or if the medication is not working||
2175|048|H|as well, or if your headaches get worse.||
2175|049|B|||
2175|050|S|SIDE EFFECTS:  Drowsiness, dizziness, tiredness, or||
2175|051|S|numbness/tingling of the skin or mouth may occur. If any of these||
2175|052|S|effects last or get worse, tell your doctor or pharmacist||
2175|053|S|promptly.||
2175|054|S|   Remember that this medication has been prescribed because your||
2175|055|S|doctor has judged that the benefit to you is greater than the||
2175|056|S|risk of side effects. Many people using this medication do not||
2175|057|S|have serious side effects.||
2175|058|S|   This medication may raise your blood pressure. Check your||
2175|059|S|blood pressure regularly and tell your doctor if the results are||
2175|060|S|high.||
2175|061|S|   Tell your doctor right away if you have any serious side||
2175|062|S|effects, including: slow heartbeat, mental/mood changes.||
2175|063|S|   This medication may increase serotonin and rarely cause a very||
2175|064|S|serious condition called serotonin syndrome/toxicity. The risk||
2175|065|S|increases if you are also taking other drugs that increase||
2175|066|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2175|067|S|take (see Drug Interactions section). Get medical help right away||
2175|068|S|if you develop some of the following symptoms: fast heartbeat,||
2175|069|S|hallucinations, loss of coordination, severe dizziness, severe||
2175|070|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2175|071|S|unusual agitation/restlessness.||
2175|072|S|   A very serious allergic reaction to this drug is rare.||
2175|073|S|However, get medical help right away if you notice any symptoms||
2175|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2175|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2175|076|S|breathing.||
2175|077|S|   This is not a complete list of possible side effects. If you||
2175|078|S|notice other effects not listed above, contact your doctor or||
2175|079|S|pharmacist.||
2175|080|S|   In the US -||
2175|081|S|   Call your doctor for medical advice about side effects. You||
2175|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2175|083|S|www.fda.gov/medwatch.||
2175|084|S|   In Canada - Call your doctor for medical advice about side||
2175|085|S|effects. You may report side effects to Health Canada at||
2175|086|S|1-866-234-2345.||
2175|087|B|||
2175|088|P|PRECAUTIONS:  Before using lasmiditan, tell your doctor or||
2175|089|P|pharmacist if you are allergic to it; or if you have any other||
2175|090|P|allergies. This product may contain inactive ingredients, which||
2175|091|P|can cause allergic reactions or other problems. Talk to your||
2175|092|P|pharmacist for more details.||
2175|093|P|   Before using this medication, tell your doctor or pharmacist||
2175|094|P|your medical history, especially of: slow heartbeat, liver||
2175|095|P|disease, high blood pressure, personal or family history of a||
2175|096|P|substance use disorder (such as overuse of or addiction to||
2175|097|P|drugs/alcohol).||
2175|098|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2175|099|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2175|100|P|machinery, or do anything that needs alertness for at least 8||
2175|101|P|hours after taking this medication and until you can do it||
2175|102|P|safely. Avoid alcoholic beverages. Talk to your doctor if you are||
2175|103|P|using marijuana (cannabis).||
2175|104|P|   Before having surgery, tell your doctor or dentist about all||
2175|105|P|the products you use (including prescription drugs,||
2175|106|P|nonprescription drugs, and herbal products).||
2175|107|P|   Older adults may be more sensitive to the side effects of this||
2175|108|P|drug, especially dizziness and increased blood pressure.||
2175|109|P|   During pregnancy, this medication should be used only when||
2175|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
2175|111|P|   It is unknown if this drug passes into breast milk. Consult||
2175|112|P|your doctor before breastfeeding.||
2175|113|B|||
2175|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2175|115|I|medications work or increase your risk for serious side effects.||
2175|116|I|This document does not contain all possible drug interactions.||
2175|117|I|Keep a list of all the products you use (including||
2175|118|I|prescription/nonprescription drugs and herbal products) and share||
2175|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
2175|120|I|the dosage of any medicines without your doctor's approval.||
2175|121|I|   The risk of serotonin syndrome/toxicity increases if you are||
2175|122|I|also taking other drugs that increase serotonin. Examples include||
2175|123|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
2175|124|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2175|125|I|SNRIs such as duloxetine/venlafaxine), MAO inhibitors||
2175|126|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2175|127|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2175|128|I|selegiline, tranylcypromine), among others. The risk of serotonin||
2175|129|I|syndrome/toxicity may be more likely when you start or increase||
2175|130|I|the dose of these drugs.||
2175|131|I|   Tell your doctor or pharmacist if you are using other products||
2175|132|I|that cause drowsiness such as opioid pain or cough relievers||
2175|133|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2175|134|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2175|135|I|zolpidem), muscle relaxants (such as carisoprodol,||
2175|136|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2175|137|I|diphenhydramine).||
2175|138|I|   Check the labels on all your medicines (such as allergy or||
2175|139|I|cough-and-cold products) because they may contain ingredients||
2175|140|I|that cause drowsiness. Ask your pharmacist about using those||
2175|141|I|products safely.||
2175|142|B|||
2175|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2175|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2175|145|O|poison control center right away. US residents can call||
2175|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2175|147|B|||
2175|148|N|NOTES:  Do not share this medication with others. Sharing it is||
2175|149|N|against the law.||
2175|150|N|   Certain foods, beverages, or food additives (such as red wine,||
2175|151|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
2175|152|N|patterns such as irregular eating/sleeping habits or stress may||
2175|153|N|bring on a migraine headache. Avoiding these "triggers" may help||
2175|154|N|lessen migraine attacks. Consult your doctor for more details.||
2175|155|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
2175|156|N|may be done while you are using this medication. Consult your||
2175|157|N|doctor for more details.||
2175|158|B|||
2175|159|D|MISSED DOSE:  Not applicable.||
2175|160|B|||
2175|161|R|STORAGE:  Store at room temperature away from light and moisture.||
2175|162|R|Do not store in the bathroom. Keep all medications away from||
2175|163|R|children and pets.||
2175|164|R|   Do not flush medications down the toilet or pour them into a||
2175|165|R|drain unless instructed to do so. Properly discard this product||
2175|166|R|when it is expired or no longer needed. Consult your pharmacist||
2175|167|R|or local waste disposal company.||
2175|168|B|||
2175|169|A|Information last revised April 2025.||
2175|170|A|Copyright(c) 2025 First Databank, Inc.||
2175|171|B|||
2176|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2176|002|Z|does NOT have all possible information about this product. This||
2176|003|Z|information does not assure that this product is safe, effective,||
2176|004|Z|or appropriate for you. This information is not individual||
2176|005|Z|medical advice and does not substitute for the advice of your||
2176|006|Z|health care professional. Always ask your health care||
2176|007|Z|professional for complete information about this product and your||
2176|008|Z|specific health needs.||
2176|009|B|||
2176|010|T|TAZEMETOSTAT - ORAL||
2176|011|F|(TAZ-e-MET-oh-stat)||
2176|012|B|||
2176|013|C|COMMON BRAND NAME(S): Tazverik||
2176|014|B|||
2176|015|U|USES:  This medication is used to treat certain types of cancer||
2176|016|U|(epithelioid sarcoma or follicular lymphoma). It works by slowing||
2176|017|U|or stopping the growth of cancer cells.||
2176|018|B|||
2176|019|H|HOW TO USE:  Read the Medication Guide provided by your||
2176|020|H|pharmacist before you start taking tazemetostat and each time you||
2176|021|H|get a refill. If you have any questions, ask your doctor or||
2176|022|H|pharmacist.||
2176|023|H|   Take this medication by mouth with or without food as directed||
2176|024|H|by your doctor, usually twice daily. Swallow the tablets whole.||
2176|025|H|   If you miss a dose or vomit after taking a dose, do not take||
2176|026|H|another dose to make up. Take your next dose at the regular time.||
2176|027|H|   The dosage is based on your medical condition, response to||
2176|028|H|treatment, and other medications you may be taking. Be sure to||
2176|029|H|tell your doctor and pharmacist about all the products you use||
2176|030|H|(including prescription drugs, nonprescription drugs, and herbal||
2176|031|H|products).||
2176|032|H|   Use this medication regularly to get the most benefit from it.||
2176|033|H|To help you remember, take it at the same times each day.||
2176|034|H|   Do not increase your dose or use this drug more often or for||
2176|035|H|longer than prescribed. Your condition will not improve any||
2176|036|H|faster, and your risk of serious side effects will increase.||
2176|037|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2176|038|H|using this medication unless your doctor or pharmacist says you||
2176|039|H|may do so safely. Grapefruit can increase the chance of side||
2176|040|H|effects with this medicine. Ask your doctor or pharmacist for||
2176|041|H|more details.||
2176|042|H|   Since this drug can be absorbed through the skin and lungs and||
2176|043|H|may harm an unborn baby, women who are pregnant or who may become||
2176|044|H|pregnant should not handle this medication or breathe the dust||
2176|045|H|from the tablets.||
2176|046|B|||
2176|047|S|SIDE EFFECTS:  Muscle/joint/abdominal pain, tiredness,||
2176|048|S|constipation, diarrhea, headache, nausea, vomiting, or loss of||
2176|049|S|appetite may occur. Nausea and vomiting can be severe. In some||
2176|050|S|cases, your doctor may prescribe medication to prevent or relieve||
2176|051|S|nausea and vomiting. Eating several small meals, not eating||
2176|052|S|before treatment, or limiting activity may help lessen some of||
2176|053|S|these effects. If any of these effects last or get worse, tell||
2176|054|S|your doctor or pharmacist promptly.||
2176|055|S|   People using this medication may have serious side effects.||
2176|056|S|However, you have been prescribed this drug because your doctor||
2176|057|S|has judged that the benefit to you is greater than the risk of||
2176|058|S|side effects. Careful monitoring by your doctor may decrease your||
2176|059|S|risk.||
2176|060|S|   Tell your doctor right away if you have any serious side||
2176|061|S|effects, including: easy bruising/bleeding.||
2176|062|S|   This medication may lower your ability to fight infections.||
2176|063|S|This may make you more likely to get a serious (rarely fatal)||
2176|064|S|infection or make any infection you have worse. Tell your doctor||
2176|065|S|right away if you have any signs of infection (such as sore||
2176|066|S|throat that doesn't go away, fever, chills).||
2176|067|S|   People who are treated with this medication may rarely get||
2176|068|S|other cancers. Consult your doctor for more details.||
2176|069|S|   A very serious allergic reaction to this drug is rare.||
2176|070|S|However, get medical help right away if you notice any symptoms||
2176|071|S|of a serious allergic reaction, including: rash, itching/swelling||
2176|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2176|073|S|breathing.||
2176|074|S|   This is not a complete list of possible side effects. If you||
2176|075|S|notice other effects not listed above, contact your doctor or||
2176|076|S|pharmacist.||
2176|077|S|   In the US -||
2176|078|S|   Call your doctor for medical advice about side effects. You||
2176|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2176|080|S|www.fda.gov/medwatch.||
2176|081|S|   In Canada - Call your doctor for medical advice about side||
2176|082|S|effects. You may report side effects to Health Canada at||
2176|083|S|1-866-234-2345.||
2176|084|B|||
2176|085|P|PRECAUTIONS:  Before taking tazemetostat, tell your doctor or||
2176|086|P|pharmacist if you are allergic to it; or if you have any other||
2176|087|P|allergies. This product may contain inactive ingredients, which||
2176|088|P|can cause allergic reactions or other problems. Talk to your||
2176|089|P|pharmacist for more details.||
2176|090|P|   Before using this medication, tell your doctor or pharmacist||
2176|091|P|your medical history, especially of: liver problems.||
2176|092|P|   Tazemetostat can make you more likely to get infections or may||
2176|093|P|make current infections worse. Stay away from anyone who has an||
2176|094|P|infection that may easily spread (such as chickenpox, COVID-19,||
2176|095|P|measles, flu). Talk to your doctor if you have been exposed to an||
2176|096|P|infection or for more details.||
2176|097|P|   Tell your health care professional that you are using||
2176|098|P|tazemetostat before having any immunizations/vaccinations. Avoid||
2176|099|P|contact with people who have recently received live vaccines||
2176|100|P|(such as flu vaccine inhaled through the nose).||
2176|101|P|   To lower the chance of getting cut, bruised, or injured, use||
2176|102|P|caution with sharp objects like razors and nail cutters, and||
2176|103|P|avoid activities such as contact sports.||
2176|104|P|   Before having surgery, tell your doctor or dentist about all||
2176|105|P|the products you use (including prescription drugs,||
2176|106|P|nonprescription drugs, and herbal products).||
2176|107|P|   Tell your doctor if you are pregnant or plan to become||
2176|108|P|pregnant. You should not become pregnant while using||
2176|109|P|tazemetostat. Tazemetostat may harm an unborn baby. Your doctor||
2176|110|P|should order a pregnancy test before you start this medication.||
2176|111|P|Women using this medication should ask about reliable forms of||
2176|112|P|birth control during treatment and for 6 months after the last||
2176|113|P|dose. Men using this medication should ask about reliable forms||
2176|114|P|of birth control during treatment and for at least 3 months after||
2176|115|P|the last dose. If you or your partner becomes pregnant, talk to||
2176|116|P|your doctor right away about the risks and benefits of this||
2176|117|P|medication.||
2176|118|P|   Since this drug can be absorbed through the skin and lungs and||
2176|119|P|may harm an unborn baby, women who are pregnant or who may become||
2176|120|P|pregnant should not handle this medication or breathe the dust||
2176|121|P|from the tablets.||
2176|122|P|   It is unknown if this drug passes into breast milk. Because of||
2176|123|P|the possible risk to the infant, breastfeeding is not recommended||
2176|124|P|while using this drug and for 1 week after the last dose. Consult||
2176|125|P|your doctor before breastfeeding.||
2176|126|B|||
2176|127|I|DRUG INTERACTIONS:  See also How to Use section.||
2176|128|I|   Drug interactions may change how your medications work or||
2176|129|I|increase your risk for serious side effects. This document does||
2176|130|I|not contain all possible drug interactions. Keep a list of all||
2176|131|I|the products you use (including prescription/nonprescription||
2176|132|I|drugs and herbal products) and share it with your doctor and||
2176|133|I|pharmacist. Do not start, stop, or change the dosage of any||
2176|134|I|medicines without your doctor's approval.||
2176|135|I|   Other medications can affect the removal of tazemetostat from||
2176|136|I|your body, which may affect how tazemetostat works. Examples||
2176|137|I|include azole antifungals (such as ketoconazole, itraconazole),||
2176|138|I|clarithromycin, nefazodone, rifamycins (such as rifampin,||
2176|139|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
2176|140|I|seizures (such as carbamazepine, phenytoin), among others.||
2176|141|I|   This medication may decrease the effectiveness of hormonal||
2176|142|I|birth control such as pills, patch, or ring. This could cause||
2176|143|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2176|144|I|use reliable backup birth control methods while using this||
2176|145|I|medication. Also tell your doctor if you have any new spotting or||
2176|146|I|breakthrough bleeding, because these may be signs that your birth||
2176|147|I|control is not working well.||
2176|148|B|||
2176|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2176|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2176|151|O|poison control center right away. US residents can call||
2176|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2176|153|B|||
2176|154|N|NOTES:  Do not share this medication with others.||
2176|155|N|   Lab and/or medical tests (such as complete blood counts, liver||
2176|156|N|function) may be done while you are taking this medication. Keep||
2176|157|N|all medical and lab appointments.||
2176|158|B|||
2176|159|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2176|160|D|next dose at the regular time. Do not double the dose to catch||
2176|161|D|up.||
2176|162|B|||
2176|163|R|STORAGE:  Store at room temperature away from light and moisture.||
2176|164|R|Do not store in the bathroom. Keep all medications away from||
2176|165|R|children and pets.||
2176|166|R|   Do not flush medications down the toilet or pour them into a||
2176|167|R|drain unless instructed to do so. Properly discard this product||
2176|168|R|when it is expired or no longer needed. Consult your pharmacist||
2176|169|R|or local waste disposal company.||
2176|170|B|||
2176|171|M|MEDICAL ALERT:  Your condition can cause complications in a||
2176|172|M|medical emergency. For information about enrolling in MedicAlert,||
2176|173|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2176|174|B|||
2176|175|A|Information last revised April 2025.||
2176|176|A|Copyright(c) 2025 First Databank, Inc.||
2176|177|B|||
2177|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2177|002|Z|does NOT have all possible information about this product. This||
2177|003|Z|information does not assure that this product is safe, effective,||
2177|004|Z|or appropriate for you. This information is not individual||
2177|005|Z|medical advice and does not substitute for the advice of your||
2177|006|Z|health care professional. Always ask your health care||
2177|007|Z|professional for complete information about this product and your||
2177|008|Z|specific health needs.||
2177|009|B|||
2177|010|T|TIBOLONE - ORAL||
2177|011|F|(TYE-boe-lone)||
2177|012|B|||
2177|013|W|WARNING:  Tibolone has rarely caused very serious side effects||
2177|014|W|(such as stroke, cancer of the breast/uterus). Discuss the risks||
2177|015|W|and benefits of treatment with your doctor.||
2177|016|W|   The risk for serious side effects may depend on the dose of||
2177|017|W|tibolone and the length of time it is used. Use this medication||
2177|018|W|at the lowest effective dose and for the shortest amount of time.||
2177|019|W|Check with your doctor regularly (for example, every 3 to 6||
2177|020|W|months) to see if you still need to take this medication. If you||
2177|021|W|will be taking this medication long term, you should have||
2177|022|W|complete physical exams regularly (for example, once a year) as||
2177|023|W|directed by your doctor. See also Notes section.||
2177|024|B|||
2177|025|U|USES:  This medication is used by women with a uterus to help||
2177|026|U|reduce symptoms of menopause (such as hot flashes, vaginal||
2177|027|U|dryness). Tibolone is not a hormone, but works by acting like||
2177|028|U|certain hormones (estrogen, progesterone, testosterone) in some||
2177|029|U|parts of the body.||
2177|030|U|   If you are using this medication to treat symptoms only in and||
2177|031|U|around the vagina, consider using products applied directly||
2177|032|U|inside the vagina instead of medications that are taken by mouth,||
2177|033|U|absorbed through the skin, or injected.||
2177|034|B|||
2177|035|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2177|036|H|from your pharmacist before you start taking tibolone and each||
2177|037|H|time you get a refill. If you have any questions, ask your doctor||
2177|038|H|or pharmacist.||
2177|039|H|   Take this medication by mouth with or without food as directed||
2177|040|H|by your doctor, usually once daily with water or another||
2177|041|H|beverage. Swallow the tablet whole. Do not chew or crush the||
2177|042|H|tablet.||
2177|043|H|   Take this medication regularly to get the most benefit from||
2177|044|H|it. To help you remember, take it at the same time each day. Do||
2177|045|H|not increase your dose or take this medication more often or for||
2177|046|H|longer than prescribed.||
2177|047|H|   Tell your doctor if your condition does not get better or if||
2177|048|H|it gets worse.||
2177|049|B|||
2177|050|S|SIDE EFFECTS:  See also Warning section.||
2177|051|S|   Stomach upset, nausea/vomiting, bloating, breast tenderness,||
2177|052|S|headache, or weight changes may occur. If any of these effects||
2177|053|S|last or get worse, tell your doctor or pharmacist promptly.||
2177|054|S|   Remember that this medication has been prescribed because your||
2177|055|S|doctor has judged that the benefit to you is greater than the||
2177|056|S|risk of side effects. Many people using this medication do not||
2177|057|S|have serious side effects.||
2177|058|S|   Tell your doctor right away if you have any serious side||
2177|059|S|effects, including: nausea/vomiting that doesn't stop, lumps in||
2177|060|S|the breast, mental/mood changes (such as depression, memory||
2177|061|S|loss), severe stomach/abdominal pain, yellowing eyes/skin, dark||
2177|062|S|urine, swelling hands/ankles/feet, increased thirst/urination,||
2177|063|S|unusual vaginal bleeding (such as spotting, sudden heavy||
2177|064|S|bleeding).||
2177|065|S|   This medication may raise your blood pressure. Check your||
2177|066|S|blood pressure regularly and tell your doctor if the results are||
2177|067|S|high.||
2177|068|S|   This medication may rarely cause serious (sometimes fatal)||
2177|069|S|problems from blood clots (such as heart attack, stroke, blood||
2177|070|S|clots in the lungs or legs). Get medical help right away if you||
2177|071|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
2177|072|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
2177|073|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2177|074|S|trouble speaking, weakness on one side of the body, sudden vision||
2177|075|S|changes.||
2177|076|S|   A very serious allergic reaction to this product is rare.||
2177|077|S|However, get medical help right away if you notice any symptoms||
2177|078|S|of a serious allergic reaction, including: rash, itching/swelling||
2177|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2177|080|S|breathing.||
2177|081|S|   This is not a complete list of possible side effects. If you||
2177|082|S|notice other effects not listed above, contact your doctor or||
2177|083|S|pharmacist.||
2177|084|S|   In the US -||
2177|085|S|   Call your doctor for medical advice about side effects. You||
2177|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2177|087|S|www.fda.gov/medwatch.||
2177|088|S|   In Canada - Call your doctor for medical advice about side||
2177|089|S|effects. You may report side effects to Health Canada at||
2177|090|S|1-866-234-2345.||
2177|091|B|||
2177|092|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2177|093|P|pharmacist if you are allergic to it; or if you have any other||
2177|094|P|allergies. This product may contain inactive ingredients, which||
2177|095|P|can cause allergic reactions or other problems. Talk to your||
2177|096|P|pharmacist for more details.||
2177|097|P|   Before using this medication, tell your doctor or pharmacist||
2177|098|P|your medical history, especially of: vaginal bleeding of unknown||
2177|099|P|cause, diabetes, cancer (especially breast cancer, cancer of the||
2177|100|P|uterus/ovaries), blood clots, blood clotting disorders (such as||
2177|101|P|protein C or protein S deficiency), family medical history||
2177|102|P|(especially of breast lumps, cancer, blood clots), family or||
2177|103|P|personal history of a certain swelling disorder (angioedema),||
2177|104|P|gallbladder disease, heart disease (such as irregular heartbeat,||
2177|105|P|previous heart attack), high blood pressure, high||
2177|106|P|cholesterol/triglyceride levels, kidney disease, liver disease,||
2177|107|P|lupus, mental/mood disorders (such as dementia, depression),||
2177|108|P|migraine headaches, underactive thyroid (hypothyroidism), mineral||
2177|109|P|imbalance (low or high level of calcium in the blood), obesity, a||
2177|110|P|certain hormone problem (hypoparathyroidism), uterus problems||
2177|111|P|(such as fibroids, endometriosis), asthma, seizures, stroke, a||
2177|112|P|certain blood disorder (porphyria).||
2177|113|P|   Do not smoke or use tobacco. Tibolone combined with smoking||
2177|114|P|further increases your risk of stroke, blood clots, high blood||
2177|115|P|pressure, and heart attack, especially in women older than 35.||
2177|116|P|   Tell your doctor if you just had or will be having surgery, or||
2177|117|P|if you will be confined to a chair or bed for a long time (such||
2177|118|P|as a long plane flight). These conditions increase your risk of||
2177|119|P|getting blood clots, especially if you are taking tibolone. You||
2177|120|P|may need to stop this medication for a time or take special||
2177|121|P|precautions.||
2177|122|P|   Before having surgery, tell your doctor or dentist about all||
2177|123|P|the products you use (including prescription drugs,||
2177|124|P|nonprescription drugs, and herbal products).||
2177|125|P|   This medication may cause blotchy, dark areas on your face and||
2177|126|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
2177|127|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
2177|128|P|wear protective clothing when outdoors.||
2177|129|P|   If you are nearsighted or wear contact lenses, you may develop||
2177|130|P|vision problems or trouble wearing your contact lenses. Contact||
2177|131|P|your eye doctor if these problems occur.||
2177|132|P|   This medication must not be used during pregnancy. If you||
2177|133|P|become pregnant or think you may be pregnant, tell your doctor||
2177|134|P|right away.||
2177|135|P|   It is unknown if this medication passes into breast milk.||
2177|136|P|Breastfeeding is not recommended while using this medication.||
2177|137|P|Consult your doctor before breastfeeding.||
2177|138|B|||
2177|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2177|140|I|medications work or increase your risk for serious side effects.||
2177|141|I|This document does not contain all possible drug interactions.||
2177|142|I|Keep a list of all the products you use (including||
2177|143|I|prescription/nonprescription drugs and herbal products) and share||
2177|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
2177|145|I|the dosage of any medicines without your doctor's approval.||
2177|146|I|   Some products that may interact with this drug are: aromatase||
2177|147|I|inhibitors (such as anastrozole, exemestane, letrozole), estrogen||
2177|148|I|agonist/antagonists (such as ospemifene, raloxifene), tranexamic||
2177|149|I|acid.||
2177|150|I|   This medication may interfere with certain lab tests (such as||
2177|151|I|blood clotting tests, thyroid tests), possibly causing false test||
2177|152|I|results. Make sure lab personnel and all your doctors know you||
2177|153|I|use this drug.||
2177|154|B|||
2177|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2177|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2177|157|O|poison control center right away. US residents can call||
2177|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2177|159|B|||
2177|160|N|NOTES:  Do not share this medication with others.||
2177|161|N|   You should have regular complete physical exams including||
2177|162|N|blood pressure, breast exam, pelvic exam, and screening for||
2177|163|N|cervical cancer (Pap smear). Follow your doctor's instructions||
2177|164|N|for examining your own breasts, and report any lumps right away.||
2177|165|N|Keep all medical and lab appointments. Consult your doctor for||
2177|166|N|more details.||
2177|167|N|   Preventing or controlling high blood pressure, high||
2177|168|N|cholesterol, and diabetes can help to reduce your chances of||
2177|169|N|heart disease and stroke. Lifestyle changes that can help to||
2177|170|N|control or prevent these diseases include reducing stress, eating||
2177|171|N|a low fat/salt diet, losing weight if overweight, exercising||
2177|172|N|regularly, and stopping smoking. Talk to your doctor about||
2177|173|N|lifestyle changes that might benefit you.||
2177|174|N|   Lifestyle changes that may help reduce hot flashes include||
2177|175|N|stopping smoking, dressing lightly or in layers,||
2177|176|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
2177|177|N|reducing stress, and exercising regularly.||
2177|178|B|||
2177|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2177|180|D|remember. If it is more than 12 hours after the missed dose, skip||
2177|181|D|the missed dose. Take your next dose at the regular time. Do not||
2177|182|D|double the dose to catch up.||
2177|183|B|||
2177|184|R|STORAGE:  Store in the original package at room temperature away||
2177|185|R|from light and moisture. Do not store in the bathroom. Keep all||
2177|186|R|medications away from children and pets.||
2177|187|R|   Do not flush medications down the toilet or pour them into a||
2177|188|R|drain unless instructed to do so. Properly discard this product||
2177|189|R|when it is expired or no longer needed. Consult your pharmacist||
2177|190|R|or local waste disposal company.||
2177|191|B|||
2177|192|A|Information last revised February 2025.||
2177|193|A|Copyright(c) 2025 First Databank, Inc.||
2177|194|B|||
2178|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2178|002|Z|does NOT have all possible information about this product. This||
2178|003|Z|information does not assure that this product is safe, effective,||
2178|004|Z|or appropriate for you. This information is not individual||
2178|005|Z|medical advice and does not substitute for the advice of your||
2178|006|Z|health care professional. Always ask your health care||
2178|007|Z|professional for complete information about this product and your||
2178|008|Z|specific health needs.||
2178|009|B|||
2178|010|T|CEFIDEROCOL - INJECTION||
2178|011|F|(SEF-i-DER-oh-kol)||
2178|012|B|||
2178|013|C|COMMON BRAND NAME(S): Fetroja||
2178|014|B|||
2178|015|U|USES:  Cefiderocol is used to treat certain serious bacterial||
2178|016|U|infections (such as kidney or urinary tract infections,||
2178|017|U|pneumonia). This medication belongs to a class of drugs known as||
2178|018|U|cephalosporin antibiotics. It works by stopping the growth of||
2178|019|U|bacteria.||
2178|020|B|||
2178|021|H|HOW TO USE:  This medication is given by injection into a vein||
2178|022|H|over 3 hours as directed by your doctor, usually every 8 hours.||
2178|023|H|The dosage is based on your medical condition and response to||
2178|024|H|treatment.||
2178|025|H|   If you are using this medication at home, learn all||
2178|026|H|preparation and usage instructions from your health care||
2178|027|H|professional. Before using, check this product for particles or||
2178|028|H|discoloration. If either is present, do not use the liquid. Learn||
2178|029|H|how to store and discard medical supplies safely.||
2178|030|H|   For the best effect, use this antibiotic at evenly spaced||
2178|031|H|times. To help you remember, use this medication at the same||
2178|032|H|times every day.||
2178|033|H|   Continue to use this medication until the full prescribed||
2178|034|H|treatment period is finished, even if symptoms disappear after a||
2178|035|H|few days. Stopping the medication too early may result in a||
2178|036|H|return of the infection.||
2178|037|H|   Tell your doctor if your condition lasts or gets worse.||
2178|038|B|||
2178|039|S|SIDE EFFECTS:  Swelling, redness, or pain at the injection site||
2178|040|S|may occur. Diarrhea, nausea, vomiting, or headache may also||
2178|041|S|occur. If any of these effects last or get worse, tell your||
2178|042|S|doctor or pharmacist promptly.||
2178|043|S|   Remember that this medication has been prescribed because your||
2178|044|S|doctor has judged that the benefit to you is greater than the||
2178|045|S|risk of side effects. Many people using this medication do not||
2178|046|S|have serious side effects.||
2178|047|S|   Tell your doctor right away if you have any serious side||
2178|048|S|effects, including: uncontrollable movements, mental/mood changes||
2178|049|S|(such as confusion).||
2178|050|S|   Get medical help right away if you have any very serious side||
2178|051|S|effects, including: seizures.||
2178|052|S|   This medication may rarely cause a severe intestinal condition||
2178|053|S|due to a bacteria called C. difficile. This condition may occur||
2178|054|S|during treatment or weeks to months after treatment has stopped.||
2178|055|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2178|056|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2178|057|S|stool.||
2178|058|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2178|059|S|products because they may make symptoms worse.||
2178|060|S|   This medication may sometimes cause oral thrush or a new yeast||
2178|061|S|infection. Contact your doctor if you notice white patches in||
2178|062|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2178|063|S|   A very serious allergic reaction to this drug is rare.||
2178|064|S|However, get medical help right away if you notice any symptoms||
2178|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2178|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2178|067|S|breathing.||
2178|068|S|   This is not a complete list of possible side effects. If you||
2178|069|S|notice other effects not listed above, contact your doctor or||
2178|070|S|pharmacist.||
2178|071|S|   In the US -||
2178|072|S|   Call your doctor for medical advice about side effects. You||
2178|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2178|074|S|www.fda.gov/medwatch.||
2178|075|S|   In Canada - Call your doctor for medical advice about side||
2178|076|S|effects. You may report side effects to Health Canada at||
2178|077|S|1-866-234-2345.||
2178|078|B|||
2178|079|P|PRECAUTIONS:  Before using cefiderocol, tell your doctor or||
2178|080|P|pharmacist if you are allergic to it; or to other antibiotics||
2178|081|P|(such as penicillins, other cephalosporins); or if you have any||
2178|082|P|other allergies. This product may contain inactive ingredients,||
2178|083|P|which can cause allergic reactions or other problems. Talk to||
2178|084|P|your pharmacist for more details.||
2178|085|P|   Before using this medication, tell your doctor or pharmacist||
2178|086|P|your medical history, especially of: kidney disease, seizures,||
2178|087|P|stomach/intestinal diseases (such as colitis).||
2178|088|P|   Cefiderocol may cause live bacterial vaccines (such as typhoid||
2178|089|P|vaccine) to not work well. Tell your health care professional||
2178|090|P|that you are using cefiderocol before having any||
2178|091|P|immunizations/vaccinations.||
2178|092|P|   Before having surgery, tell your doctor or dentist about all||
2178|093|P|the products you use (including prescription drugs,||
2178|094|P|nonprescription drugs, and herbal products).||
2178|095|P|   During pregnancy, this medication should be used only when||
2178|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
2178|097|P|   It is unknown if this medication passes into breast milk.||
2178|098|P|Consult your doctor before breastfeeding.||
2178|099|B|||
2178|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2178|101|I|medications work or increase your risk for serious side effects.||
2178|102|I|This document does not contain all possible drug interactions.||
2178|103|I|Keep a list of all the products you use (including||
2178|104|I|prescription/nonprescription drugs and herbal products) and share||
2178|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
2178|106|I|the dosage of any medicines without your doctor's approval.||
2178|107|I|   This medication may interfere with certain lab tests (such as||
2178|108|I|certain urine glucose tests), possibly causing false test||
2178|109|I|results. Make sure lab personnel and all your doctors know you||
2178|110|I|use this drug.||
2178|111|B|||
2178|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2178|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2178|114|O|poison control center right away. US residents can call||
2178|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2178|116|B|||
2178|117|N|NOTES:  Lab and/or medical tests (such as liver/kidney function,||
2178|118|N|blood mineral levels) may be done while you are using this||
2178|119|N|medication. Keep all medical and lab appointments.||
2178|120|B|||
2178|121|D|MISSED DOSE:  It is important to get each dose of this medication||
2178|122|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2178|123|D|right away for a new dosing schedule. Do not double the dose to||
2178|124|D|catch up.||
2178|125|B|||
2178|126|R|STORAGE:  Consult the product instructions and your pharmacist||
2178|127|R|for storage details. Keep all medications away from children and||
2178|128|R|pets.||
2178|129|R|   Do not flush medications down the toilet or pour them into a||
2178|130|R|drain unless instructed to do so. Properly discard this product||
2178|131|R|when it is expired or no longer needed. Consult your pharmacist||
2178|132|R|or local waste disposal company.||
2178|133|B|||
2178|134|A|Information last revised December 2024.||
2178|135|A|Copyright(c) 2025 First Databank, Inc.||
2178|136|B|||
2179|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2179|002|Z|does NOT have all possible information about this product. This||
2179|003|Z|information does not assure that this product is safe, effective,||
2179|004|Z|or appropriate for you. This information is not individual||
2179|005|Z|medical advice and does not substitute for the advice of your||
2179|006|Z|health care professional. Always ask your health care||
2179|007|Z|professional for complete information about this product and your||
2179|008|Z|specific health needs.||
2179|009|B|||
2179|010|T|ITRACONAZOLE - ORAL||
2179|011|F|(IT-ra-KON-a-zole)||
2179|012|B|||
2179|013|C|COMMON BRAND NAME(S): Sporanox||
2179|014|B|||
2179|015|W|WARNING:  Itraconazole should not be used to treat fungal nail||
2179|016|W|infections if you have a history of heart failure. Itraconazole||
2179|017|W|may rarely cause or worsen heart failure. Tell your doctor right||
2179|018|W|away if you develop symptoms of heart failure, such as shortness||
2179|019|W|of breath, swelling ankles/feet, unusual tiredness, or||
2179|020|W|unusual/sudden unexplained weight gain. Consult your doctor for||
2179|021|W|more details.||
2179|022|W|   This medication can slow down the removal of other medications||
2179|023|W|from your body, which may cause very serious (possibly fatal)||
2179|024|W|side effects to occur. Examples of affected drugs include certain||
2179|025|W|"blood thinners" (such as ticagrelor), colchicine, certain drugs||
2179|026|W|to treat irregular heartbeat (such disopyramide, dofetilide,||
2179|027|W|dronedarone, quinidine), eplerenone, ergot alkaloids (such as||
2179|028|W|dihydroergotamine, ergotamine, methylergonovine), felodipine,||
2179|029|W|fesoterodine, irinotecan, ivabradine, lurasidone, methadone,||
2179|030|W|midazolam, nisoldipine, pimozide, ranolazine, certain "statin"||
2179|031|W|cholesterol drugs (such as lovastatin, simvastatin), solifenacin,||
2179|032|W|telithromycin, triazolam, among others. Be sure to tell your||
2179|033|W|doctor and pharmacist about all the products you use (including||
2179|034|W|prescription drugs, nonprescription drugs, and herbal products).||
2179|035|B|||
2179|036|U|USES:  Itraconazole is used to treat a variety of fungal||
2179|037|U|infections. It belongs to a class of drugs known as azole||
2179|038|U|antifungals. It works by stopping the growth of fungi.||
2179|039|B|||
2179|040|V|OTHER USES:  This section contains uses of this drug that are not||
2179|041|V|listed in the approved professional labeling for the drug but||
2179|042|V|that may be prescribed by your health care professional. Use this||
2179|043|V|drug for a condition that is listed in this section only if it||
2179|044|V|has been so prescribed by your health care professional.||
2179|045|V|   This drug may also be used to reduce the risk of certain||
2179|046|V|fungal infections.||
2179|047|B|||
2179|048|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2179|049|H|from your pharmacist before you start taking itraconazole and||
2179|050|H|each time you get a refill. If you have any questions, ask your||
2179|051|H|doctor or pharmacist.||
2179|052|H|   Take this medication by mouth with a full meal as directed by||
2179|053|H|your doctor, usually once or twice daily. Swallow the capsules||
2179|054|H|whole.||
2179|055|H|   Medications that reduce stomach acid (such as antacids, proton||
2179|056|H|pump inhibitors/PPIs, H2 blockers) may make itraconazole work||
2179|057|H|less well. If you take antacids, take the antacids at least 2||
2179|058|H|hours before or 2 hours after itraconazole. If you take PPIs||
2179|059|H|(such as lansoprazole, omeprazole) or H2 blockers (such as||
2179|060|H|famotidine, nizatidine), take itraconazole with an acidic drink||
2179|061|H|(such as cola). Ask your doctor or pharmacist for more details.||
2179|062|H|   The dosage and length of treatment are based on your medical||
2179|063|H|condition and response to treatment. Take this medication exactly||
2179|064|H|as prescribed by your doctor. Some conditions may require you to||
2179|065|H|take this medication in cycles (twice daily for 1 week, then||
2179|066|H|stopping the medication for 3 weeks).||
2179|067|H|   For the best effect, take this antifungal at evenly spaced||
2179|068|H|times. To help you remember, take this medication at the same||
2179|069|H|time(s) each day. Mark your calendar with a reminder if you are||
2179|070|H|taking this medication in cycles.||
2179|071|H|   Continue to take this medication until the full prescribed||
2179|072|H|amount is finished, even if symptoms disappear after a few days.||
2179|073|H|Stopping the medication too early may result in a return of the||
2179|074|H|infection.||
2179|075|H|   The capsule, tablet, and solution forms of this medication||
2179|076|H|deliver different amounts of medication and may be used for||
2179|077|H|different purposes. Do not switch between the different forms or||
2179|078|H|brands of this drug without your doctor's direction.||
2179|079|H|   Tell your doctor if your condition does not get better or if||
2179|080|H|it gets worse.||
2179|081|B|||
2179|082|S|SIDE EFFECTS:  See also Warning section.||
2179|083|S|   Nausea/vomiting, diarrhea, headache, stomach upset, or||
2179|084|S|dizziness may occur. If any of these effects last or get worse,||
2179|085|S|tell your doctor or pharmacist promptly.||
2179|086|S|   Remember that this medication has been prescribed because your||
2179|087|S|doctor has judged that the benefit to you is greater than the||
2179|088|S|risk of side effects. Many people using this medication do not||
2179|089|S|have serious side effects.||
2179|090|S|   This medication may raise your blood pressure. Check your||
2179|091|S|blood pressure regularly and tell your doctor if the results are||
2179|092|S|high.||
2179|093|S|   Tell your doctor right away if you have any serious side||
2179|094|S|effects, including: numbness/tingling of arms/legs, hearing loss,||
2179|095|S|mental/mood changes (such as depression).||
2179|096|S|   Itraconazole has rarely caused very serious (possibly fatal)||
2179|097|S|liver disease. Tell your doctor right away if you develop||
2179|098|S|symptoms of liver disease, such as: nausea/vomiting that doesn't||
2179|099|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
2179|100|S|eyes/skin, dark urine.||
2179|101|S|   Itraconazole can commonly cause a mild rash that is usually||
2179|102|S|not serious. However, you may not be able to tell it apart from a||
2179|103|S|rare rash that could be a sign of a severe allergic reaction. Get||
2179|104|S|medical help right away if you develop any rash.||
2179|105|S|   A very serious allergic reaction to this drug is rare.||
2179|106|S|However, get medical help right away if you notice any symptoms||
2179|107|S|of a serious allergic reaction, including: rash, itching/swelling||
2179|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2179|109|S|breathing.||
2179|110|S|   This is not a complete list of possible side effects. If you||
2179|111|S|notice other effects not listed above, contact your doctor or||
2179|112|S|pharmacist.||
2179|113|S|   In the US -||
2179|114|S|   Call your doctor for medical advice about side effects. You||
2179|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2179|116|S|www.fda.gov/medwatch.||
2179|117|S|   In Canada - Call your doctor for medical advice about side||
2179|118|S|effects. You may report side effects to Health Canada at||
2179|119|S|1-866-234-2345.||
2179|120|B|||
2179|121|P|PRECAUTIONS:  See also Warning section.||
2179|122|P|   Before taking itraconazole, tell your doctor or pharmacist if||
2179|123|P|you are allergic to it; or to other azole antifungals (such as||
2179|124|P|ketoconazole); or if you have any other allergies. This product||
2179|125|P|may contain inactive ingredients, which can cause allergic||
2179|126|P|reactions or other problems. Talk to your pharmacist for more||
2179|127|P|details.||
2179|128|P|   Before using this medication, tell your doctor or pharmacist||
2179|129|P|your medical history, especially of: liver disease, kidney||
2179|130|P|disease, heart disease (such as heart failure, coronary artery||
2179|131|P|disease, heart valve disease), lung disease (such as chronic||
2179|132|P|obstructive pulmonary disease-COPD), decreased or no stomach acid||
2179|133|P|(achlorhydria).||
2179|134|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2179|135|P|can make you more dizzy. Do not drive, use machinery, or do||
2179|136|P|anything that needs alertness until you can do it safely. Avoid||
2179|137|P|alcoholic beverages. Talk to your doctor if you are using||
2179|138|P|marijuana (cannabis). Alcohol may also increase the risk of||
2179|139|P|serious liver problems.||
2179|140|P|   Before having surgery, tell your doctor or dentist about all||
2179|141|P|the products you use (including prescription drugs,||
2179|142|P|nonprescription drugs, and herbal products).||
2179|143|P|   Older adults may be at greater risk for hearing loss while||
2179|144|P|using this drug.||
2179|145|P|   During pregnancy, this medication should be used only when||
2179|146|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2179|147|P|benefits with your doctor. This medication should not be used to||
2179|148|P|treat fungal nail infections if you are pregnant or could become||
2179|149|P|pregnant during treatment. Women of childbearing age should start||
2179|150|P|this medication 2 to 3 days after the start of their periods to||
2179|151|P|make sure that they are not pregnant. Discuss the use of reliable||
2179|152|P|forms of birth control while taking this medication and for 2||
2179|153|P|months after stopping treatment.||
2179|154|P|   Itraconazole passes into breast milk. Consult your doctor||
2179|155|P|before breastfeeding.||
2179|156|B|||
2179|157|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
2179|158|I|   Drug interactions may change how your medications work or||
2179|159|I|increase your risk for serious side effects. This document does||
2179|160|I|not contain all possible drug interactions. Keep a list of all||
2179|161|I|the products you use (including prescription/nonprescription||
2179|162|I|drugs and herbal products) and share it with your doctor and||
2179|163|I|pharmacist. Do not start, stop, or change the dosage of any||
2179|164|I|medicines without your doctor's approval.||
2179|165|I|   Itraconazole interacts with many medications. See also Warning||
2179|166|I|section.||
2179|167|I|   Other medications can affect the removal of itraconazole from||
2179|168|I|your body, which may affect how itraconazole works. Examples||
2179|169|I|include efavirenz, isoniazid, nevirapine, rifamycins (such as||
2179|170|I|rifabutin), certain drugs used to treat seizures (such as||
2179|171|I|phenytoin), among others.||
2179|172|B|||
2179|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2179|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2179|175|O|poison control center right away. US residents can call||
2179|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2179|177|B|||
2179|178|N|NOTES:  Do not share this medication with others.||
2179|179|N|   This medication has been prescribed for your current condition||
2179|180|N|only. Do not use it later to treat or prevent another infection||
2179|181|N|unless your doctor tells you to.||
2179|182|N|   Lab and/or medical tests (such as liver function, potassium||
2179|183|N|level, blood pressure) should be done before you start taking||
2179|184|N|this medication and while you are taking it. Keep all medical and||
2179|185|N|lab appointments. Consult your doctor for more details.||
2179|186|B|||
2179|187|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2179|188|D|remember. If it is near the time of the next dose, skip the||
2179|189|D|missed dose. Take your next dose at the regular time. Do not||
2179|190|D|double the dose to catch up.||
2179|191|B|||
2179|192|R|STORAGE:  Store at room temperature away from light and moisture.||
2179|193|R|Do not store in the bathroom. Keep all medications away from||
2179|194|R|children and pets.||
2179|195|R|   Do not flush medications down the toilet or pour them into a||
2179|196|R|drain unless instructed to do so. Properly discard this product||
2179|197|R|when it is expired or no longer needed. Consult your pharmacist||
2179|198|R|or local waste disposal company.||
2179|199|B|||
2179|200|A|Information last revised June 2025.||
2179|201|A|Copyright(c) 2025 First Databank, Inc.||
2179|202|B|||
2180|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2180|002|Z|does NOT have all possible information about this product. This||
2180|003|Z|information does not assure that this product is safe, effective,||
2180|004|Z|or appropriate for you. This information is not individual||
2180|005|Z|medical advice and does not substitute for the advice of your||
2180|006|Z|health care professional. Always ask your health care||
2180|007|Z|professional for complete information about this product and your||
2180|008|Z|specific health needs.||
2180|009|B|||
2180|010|T|LOMITAPIDE - ORAL||
2180|011|F|(loe-MI-ta-pide)||
2180|012|B|||
2180|013|C|COMMON BRAND NAME(S): Juxtapid||
2180|014|B|||
2180|015|W|WARNING:  Lomitapide may rarely cause serious (possibly fatal)||
2180|016|W|liver disease. This medication increases fat in the liver, which||
2180|017|W|may also increase the risk for liver disease. Careful monitoring||
2180|018|W|by your doctor may decrease your risk. Lab and/or medical tests||
2180|019|W|(such as liver function) should be done before starting treatment||
2180|020|W|and while you are taking this medication. Keep all medical and||
2180|021|W|lab appointments. Get medical help right away if you have any||
2180|022|W|symptoms of liver damage, such as nausea/vomiting that doesn't||
2180|023|W|stop, loss of appetite, stomach/abdominal pain, yellowing||
2180|024|W|eyes/skin, dark urine.||
2180|025|W|   To receive lomitapide in the United States, you must||
2180|026|W|understand, agree to, and carefully follow the requirements of||
2180|027|W|the REMS Program for this medication. If you live in Canada or||
2180|028|W|any other country, consult your doctor and pharmacist for your||
2180|029|W|country's regulations.||
2180|030|B|||
2180|031|U|USES:  This medication is used along with a low-fat diet and||
2180|032|U|other treatments for a certain inherited condition that causes||
2180|033|U|very high cholesterol levels (homozygous familial||
2180|034|U|hypercholesterolemia). Very high cholesterol levels increase your||
2180|035|U|risk of developing heart and blood vessel disease. Lomitapide||
2180|036|U|works by decreasing your body's production of cholesterol.||
2180|037|B|||
2180|038|H|HOW TO USE:  Read the Medication Guide provided by your||
2180|039|H|pharmacist before you start taking lomitapide and each time you||
2180|040|H|get a refill. If you have any questions, ask your doctor or||
2180|041|H|pharmacist.||
2180|042|H|   Take this medication by mouth without food as directed by your||
2180|043|H|doctor, usually once daily with a glass of water, at least 2||
2180|044|H|hours after the evening meal. Swallow the capsules whole. Do not||
2180|045|H|open, crush, dissolve, or chew the capsules. To reduce your risk||
2180|046|H|of side effects, your doctor may direct you to start this||
2180|047|H|medication at a low dose and gradually increase your dose. Follow||
2180|048|H|your doctor's instructions carefully.||
2180|049|H|   The dosage is based on your medical condition, response to||
2180|050|H|treatment, and other medications you may be taking. Be sure to||
2180|051|H|tell your doctor and pharmacist about all the products you use||
2180|052|H|(including prescription drugs, nonprescription drugs, and herbal||
2180|053|H|products).||
2180|054|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2180|055|H|using this medication unless your doctor or pharmacist says you||
2180|056|H|may do so safely. Grapefruit can increase the chance of side||
2180|057|H|effects with this medicine. Ask your doctor or pharmacist for||
2180|058|H|more details.||
2180|059|H|   Use this medication regularly to get the most benefit from it.||
2180|060|H|To help you remember, take it at the same time each day.||
2180|061|H|   Your doctor may direct you to also take dietary supplements||
2180|062|H|(such as vitamin E, linoleic acid, DHA/EPA) while you are taking||
2180|063|H|this medication. Ask your doctor for details.||
2180|064|H|   Since this drug can be absorbed through the skin and lungs and||
2180|065|H|may harm an unborn baby, women who are pregnant or who may become||
2180|066|H|pregnant should not handle this medication or breathe the dust||
2180|067|H|from the capsules.||
2180|068|B|||
2180|069|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, upset stomach, gas,||
2180|070|S|stomach cramping/pain, weight loss, dizziness, headache,||
2180|071|S|tiredness, or constipation may occur. If any of these effects||
2180|072|S|last or get worse, tell your doctor or pharmacist promptly.||
2180|073|S|   To lessen stomach/intestinal symptoms, follow a low-fat diet||
2180|074|S|as instructed by your doctor or dietician. Taking this medication||
2180|075|S|at least 2 hours after the evening meal may also help lessen||
2180|076|S|these side effects.||
2180|077|S|   Remember that this medication has been prescribed because your||
2180|078|S|doctor has judged that the benefit to you is greater than the||
2180|079|S|risk of side effects. Many people using this medication do not||
2180|080|S|have serious side effects.||
2180|081|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2180|082|S|Contact your doctor promptly if you notice any symptoms of||
2180|083|S|dehydration, such as unusual decreased urination, unusual dry||
2180|084|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness.||
2180|085|S|   A very serious allergic reaction to this drug is rare.||
2180|086|S|However, get medical help right away if you notice any symptoms||
2180|087|S|of a serious allergic reaction, including: rash, severe||
2180|088|S|dizziness, itching/swelling (especially of the||
2180|089|S|face/tongue/throat), trouble breathing.||
2180|090|S|   This is not a complete list of possible side effects. If you||
2180|091|S|notice other effects not listed above, contact your doctor or||
2180|092|S|pharmacist.||
2180|093|S|   In the US -||
2180|094|S|   Call your doctor for medical advice about side effects. You||
2180|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2180|096|S|www.fda.gov/medwatch.||
2180|097|S|   In Canada - Call your doctor for medical advice about side||
2180|098|S|effects. You may report side effects to Health Canada at||
2180|099|S|1-866-234-2345.||
2180|100|B|||
2180|101|P|PRECAUTIONS:  Before taking lomitapide, tell your doctor or||
2180|102|P|pharmacist if you are allergic to it; or if you have any other||
2180|103|P|allergies. This product may contain inactive ingredients, which||
2180|104|P|can cause allergic reactions or other problems. Talk to your||
2180|105|P|pharmacist for more details.||
2180|106|P|   Before using this medication, tell your doctor or pharmacist||
2180|107|P|your medical history, especially of: kidney problems, liver||
2180|108|P|problems, galactose intolerance (such as Lapp lactase deficiency||
2180|109|P|or glucose-galactose malabsorption).||
2180|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2180|111|P|can make you more dizzy. Do not drive, use machinery, or do||
2180|112|P|anything that needs alertness until you can do it safely. Do not||
2180|113|P|drink more than 1 alcoholic beverage each day while taking this||
2180|114|P|medication. Talk to your doctor if you are using marijuana||
2180|115|P|(cannabis).||
2180|116|P|   Before having surgery, tell your doctor or dentist about all||
2180|117|P|the products you use (including prescription drugs,||
2180|118|P|nonprescription drugs, and herbal products).||
2180|119|P|   This medication must not be used during pregnancy. It may harm||
2180|120|P|an unborn baby. Your doctor may order a pregnancy test before||
2180|121|P|starting this medication. Ask about reliable forms of birth||
2180|122|P|control (such as condoms, birth control pills) while using this||
2180|123|P|medication and for 2 weeks after the last dose. If you become||
2180|124|P|pregnant or think you may be pregnant, tell your doctor right||
2180|125|P|away.||
2180|126|P|   Since this drug can be absorbed through the skin and lungs and||
2180|127|P|may harm an unborn baby, women who are pregnant or who may become||
2180|128|P|pregnant should not handle this medication or breathe the dust||
2180|129|P|from the capsules.||
2180|130|P|   It is unknown if this medication passes into breast milk.||
2180|131|P|Because of the possible risk to the infant, breastfeeding is not||
2180|132|P|recommended while using this medication. Consult your doctor||
2180|133|P|before breastfeeding.||
2180|134|B|||
2180|135|I|DRUG INTERACTIONS:  See also How to Use section.||
2180|136|I|   Drug interactions may change how your medications work or||
2180|137|I|increase your risk for serious side effects. This document does||
2180|138|I|not contain all possible drug interactions. Keep a list of all||
2180|139|I|the products you use (including prescription/nonprescription||
2180|140|I|drugs and herbal products) and share it with your doctor and||
2180|141|I|pharmacist. Do not start, stop, or change the dosage of any||
2180|142|I|medicines without your doctor's approval.||
2180|143|I|   Other medications can affect the removal of lomitapide from||
2180|144|I|your body, which may affect how lomitapide works. Examples||
2180|145|I|include adagrasib, aprepitant, avacopan, azole antifungals (such||
2180|146|I|as ketoconazole, itraconazole), conivaptan, macrolide antibiotics||
2180|147|I|(such as clarithromycin, erythromycin), mifepristone, nefazodone,||
2180|148|I|ritonavir, treosulfan, among others.||
2180|149|B|||
2180|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2180|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2180|152|O|poison control center right away. US residents can call||
2180|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2180|154|B|||
2180|155|N|NOTES:  Do not share this medication with others.||
2180|156|N|   Lab and/or medical tests (such as cholesterol levels, liver||
2180|157|N|function) must be done while you are taking this medication. Keep||
2180|158|N|all medical and lab appointments.||
2180|159|B|||
2180|160|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2180|161|D|next dose at the regular time. Do not double the dose to catch||
2180|162|D|up.||
2180|163|B|||
2180|164|R|STORAGE:  Store at room temperature away from light and moisture.||
2180|165|R|Do not store in the bathroom. Keep all medications away from||
2180|166|R|children and pets.||
2180|167|R|   Do not flush medications down the toilet or pour them into a||
2180|168|R|drain unless instructed to do so. Properly discard this product||
2180|169|R|when it is expired or no longer needed. Consult your pharmacist||
2180|170|R|or local waste disposal company.||
2180|171|B|||
2180|172|A|Information last revised September 2024.||
2180|173|A|Copyright(c) 2025 First Databank, Inc.||
2180|174|B|||
2182|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2182|002|Z|does NOT have all possible information about this product. This||
2182|003|Z|information does not assure that this product is safe, effective,||
2182|004|Z|or appropriate for you. This information is not individual||
2182|005|Z|medical advice and does not substitute for the advice of your||
2182|006|Z|health care professional. Always ask your health care||
2182|007|Z|professional for complete information about this product and your||
2182|008|Z|specific health needs.||
2182|009|B|||
2182|010|T|PEANUT ALLERGEN POWDER - ORAL||
2182|011|F|(PEE-nut)||
2182|012|B|||
2182|013|C|COMMON BRAND NAME(S): Palforzia||
2182|014|B|||
2182|015|W|WARNING:  This product may cause a serious (rarely fatal)||
2182|016|W|allergic reaction. This may occur at any time during treatment.||
2182|017|W|Get medical help right away if you notice any symptoms of a||
2182|018|W|serious allergic reaction, including: flushing, rash,||
2182|019|W|itching/swelling (especially of the face, tongue, throat), severe||
2182|020|W|dizziness, fainting, fast heartbeat, shortness of breath, or||
2182|021|W|trouble breathing. When you take this drug for the first time,||
2182|022|W|and any time your dose is increased, you will need to stay in a||
2182|023|W|health care setting (such as a doctor's office) for at least 60||
2182|024|W|minutes so your doctor can carefully monitor you and provide||
2182|025|W|medical help if needed.||
2182|026|W|   People with worsening asthma are especially at risk for a||
2182|027|W|serious allergic reaction. If you get worsening asthma symptoms,||
2182|028|W|talk to your doctor right away before taking your dose of this||
2182|029|W|medication.||
2182|030|W|   Your doctor will also prescribe another medication||
2182|031|W|(epinephrine) to use in case you have a serious allergic reaction||
2182|032|W|outside the health care setting. Read the Patient Information||
2182|033|W|Leaflet for this medication provided by your pharmacist. Learn||
2182|034|W|ahead of time when and how to use your brand of epinephrine. If||
2182|035|W|you have to use it, get medical help as soon as you have used it.||
2182|036|W|Also, some medications (including beta blockers such as atenolol)||
2182|037|W|may make epinephrine or other rescue medications not work as well||
2182|038|W|or increase your risk for side effects from these medications. Be||
2182|039|W|sure to tell your doctor about all the drugs you use (including||
2182|040|W|prescription/nonprescription drugs and herbal products).||
2182|041|W|   To receive peanut allergen powder in the United States, you||
2182|042|W|must understand, agree to, and carefully follow the requirements||
2182|043|W|of the REMS Program for this medication. If you live in Canada or||
2182|044|W|any other country, consult your doctor and pharmacist for your||
2182|045|W|country's regulations.||
2182|046|B|||
2182|047|U|USES:  This medication is used by people with peanut allergy to||
2182|048|U|reduce the severity of an allergic reaction when accidentally||
2182|049|U|exposed to peanuts. People using this medication should continue||
2182|050|U|to avoid eating peanuts.||
2182|051|U|   This medication is made from peanuts. It works by making your||
2182|052|U|body less sensitive to small amounts of peanuts. This medication||
2182|053|U|must be used regularly to be effective. It does not work right||
2182|054|U|away to treat an allergic reaction to peanuts.||
2182|055|B|||
2182|056|H|HOW TO USE:  See also Warning section.||
2182|057|H|   Read the Medication Guide provided by your pharmacist before||
2182|058|H|you start using this product and each time you get a refill. If||
2182|059|H|you have any questions, ask your doctor or pharmacist.||
2182|060|H|   Take this medication by mouth with a meal as directed by your||
2182|061|H|doctor, usually once daily in the evening. This medication comes||
2182|062|H|in a powder form inside a capsule or a packet. Do not swallow the||
2182|063|H|capsules or inhale the powder. To use this medication, open the||
2182|064|H|capsule(s) or packet and sprinkle the contents on a few spoonfuls||
2182|065|H|of refrigerated or room temperature soft food (such as||
2182|066|H|applesauce, yogurt, pudding). Mix the drug and food together well||
2182|067|H|and then swallow the mixture right away. Do not prepare the||
2182|068|H|mixture with liquid or prepare the mixture ahead of time for||
2182|069|H|later use. Wash your hands after handling the product.||
2182|070|H|   The dosage is based on your medical condition and response to||
2182|071|H|treatment. Be watchful for any side effects after taking the||
2182|072|H|medication, especially during the first 60 minutes after taking||
2182|073|H|it. Your first day of treatment will be in a health care setting||
2182|074|H|(such as a doctor's office) where your doctor will slowly||
2182|075|H|increase your dose of this medication and monitor you in case of||
2182|076|H|a serious reaction. For your second day of treatment, and||
2182|077|H|whenever you start a new dose of this medication (usually every 2||
2182|078|H|weeks), you will take the medication in a health care setting||
2182|079|H|where you will be monitored for at least 60 minutes in case of a||
2182|080|H|serious reaction. To reduce your risk of side effects, your||
2182|081|H|doctor will raise your dose slowly, and will adjust your dose||
2182|082|H|based on any reactions to the medication. If you are taking one||
2182|083|H|of your doses in the doctor's office, make sure not to take||
2182|084|H|another dose in the evening that day.||
2182|085|H|   Take this medication regularly to get the most benefit from||
2182|086|H|it. To help you remember, take it at the same time each day.||
2182|087|H|   Tell your doctor if your condition does not get better or if||
2182|088|H|it gets worse, or if you get a serious reaction after taking the||
2182|089|H|medication.||
2182|090|B|||
2182|091|S|SIDE EFFECTS:  Nausea, vomiting, abdominal pain, sore throat, or||
2182|092|S|numbness/itching in the mouth may occur. If any of these effects||
2182|093|S|last or get worse, tell your doctor or pharmacist promptly.||
2182|094|S|   Remember that this medication has been prescribed because your||
2182|095|S|doctor has judged that the benefit to you is greater than the||
2182|096|S|risk of side effects. Many people using this medication do not||
2182|097|S|have serious side effects.||
2182|098|S|   Get medical help right away if you have any very serious side||
2182|099|S|effects, including: trouble swallowing/speaking, chest pain,||
2182|100|S|severe stomach pain/vomiting/diarrhea.||
2182|101|S|   A very serious allergic reaction to this drug is rare.||
2182|102|S|However, get medical help right away if you notice any symptoms||
2182|103|S|of a serious allergic reaction (see also Warning section).||
2182|104|S|   This is not a complete list of possible side effects. If you||
2182|105|S|notice other effects not listed above, contact your doctor or||
2182|106|S|pharmacist.||
2182|107|S|   In the US -||
2182|108|S|   Call your doctor for medical advice about side effects. You||
2182|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2182|110|S|www.fda.gov/medwatch.||
2182|111|S|   In Canada - Call your doctor for medical advice about side||
2182|112|S|effects. You may report side effects to Health Canada at||
2182|113|S|1-866-234-2345.||
2182|114|B|||
2182|115|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2182|116|P|pharmacist if you are allergic to it; or if you have any other||
2182|117|P|allergies. This product may contain inactive ingredients, which||
2182|118|P|can cause allergic reactions or other problems. Talk to your||
2182|119|P|pharmacist for more details.||
2182|120|P|   Before using this medication, tell your doctor or pharmacist||
2182|121|P|your medical history, especially of: breathing disorders (such as||
2182|122|P|asthma), stomach/intestinal disorders (such as eosinophilic||
2182|123|P|esophagitis), heart problems (such as chest pain, previous heart||
2182|124|P|attack), previous allergic reaction, other immune system||
2182|125|P|problems.||
2182|126|P|   Before having surgery, tell your doctor or dentist about all||
2182|127|P|the products you use (including prescription drugs,||
2182|128|P|nonprescription drugs, and herbal products).||
2182|129|P|   Exercising or taking a hot shower or bath may increase your||
2182|130|P|risk for an allergic reaction to the medication. If you have just||
2182|131|P|exercised or taken a hot shower or bath, you should wait until||
2182|132|P|your body is cool and your heart is beating normally before using||
2182|133|P|this medication. Do not exercise or take a hot shower or bath for||
2182|134|P|at least 3 hours after taking this medication.||
2182|135|P|   Certain conditions may also increase your risk for an allergic||
2182|136|P|reaction to the medication. Medical conditions may include having||
2182|137|P|an illness/infection, having worsening asthma, not getting enough||
2182|138|P|sleep, fasting, or getting your period. Taking nonsteroidal||
2182|139|P|anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen) or||
2182|140|P|drinking alcohol may also increase your risk. Ask your doctor||
2182|141|P|beforehand what to do if these conditions occur.||
2182|142|P|   During pregnancy, this medication should be used only when||
2182|143|P|clearly needed. Discuss the risks and benefits with your doctor.||
2182|144|P|   It is unknown if this medication passes into breast milk.||
2182|145|P|Consult your doctor before breastfeeding.||
2182|146|B|||
2182|147|I|DRUG INTERACTIONS:  See also Warning section.||
2182|148|I|   Drug interactions may change how your medications work or||
2182|149|I|increase your risk for serious side effects. This document does||
2182|150|I|not contain all possible drug interactions. Keep a list of all||
2182|151|I|the products you use (including prescription/nonprescription||
2182|152|I|drugs and herbal products) and share it with your doctor and||
2182|153|I|pharmacist. Do not start, stop, or change the dosage of any||
2182|154|I|medicines without your doctor's approval.||
2182|155|B|||
2182|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2182|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2182|158|O|poison control center right away. US residents can call||
2182|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2182|160|O|Symptoms of overdose may include: trouble swallowing/breathing,||
2182|161|O|throat tightness/swelling.||
2182|162|B|||
2182|163|N|NOTES:  Do not share this medication with others.||
2182|164|B|||
2182|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2182|166|D|remember. If you don't remember until the next day, skip the||
2182|167|D|missed dose. Take your next dose at the regular time. Do not||
2182|168|D|double the dose to catch up or take more than one dose in a day.||
2182|169|D|If you miss more than 2 doses, call your doctor for advice.||
2182|170|B|||
2182|171|R|STORAGE:  Store in the original packaging in the refrigerator or||
2182|172|R|at room temperature. Do not freeze. Keep all medications away||
2182|173|R|from children and pets.||
2182|174|R|   Do not flush medications down the toilet or pour them into a||
2182|175|R|drain unless instructed to do so. Properly discard this product||
2182|176|R|when it is expired or no longer needed. Consult your pharmacist||
2182|177|R|or local waste disposal company.||
2182|178|B|||
2182|179|M|MEDICAL ALERT:  Your condition can cause complications in a||
2182|180|M|medical emergency. For information about enrolling in MedicAlert,||
2182|181|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2182|182|B|||
2182|183|A|Information last revised May 2024.||
2182|184|A|Copyright(c) 2025 First Databank, Inc.||
2182|185|B|||
2183|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2183|002|Z|does NOT have all possible information about this product. This||
2183|003|Z|information does not assure that this product is safe, effective,||
2183|004|Z|or appropriate for you. This information is not individual||
2183|005|Z|medical advice and does not substitute for the advice of your||
2183|006|Z|health care professional. Always ask your health care||
2183|007|Z|professional for complete information about this product and your||
2183|008|Z|specific health needs.||
2183|009|B|||
2183|010|T|CYSTEAMINE DELAYED-RELEASE GRANULES - ORAL||
2183|011|F|(sis-TEE-a-meen)||
2183|012|B|||
2183|013|C|COMMON BRAND NAME(S): Procysbi||
2183|014|B|||
2183|015|U|USES:  This medication is used to help preserve kidney function||
2183|016|U|and manage kidney damage and other problems in people with an||
2183|017|U|inherited disorder (nephropathic cystinosis) that causes buildup||
2183|018|U|of a certain natural substance (cystine) in the body. Cystine||
2183|019|U|buildup can cause problems such as kidney problems, slow growth,||
2183|020|U|weak bones, and eye problems. Cysteamine helps the body get rid||
2183|021|U|of cystine.||
2183|022|B|||
2183|023|H|HOW TO USE:  Read the Patient Information Leaflet and||
2183|024|H|Instructions for Use if available from your pharmacist before you||
2183|025|H|start using cysteamine and each time you get a refill. If you||
2183|026|H|have any questions, ask your doctor or pharmacist.||
2183|027|H|   Take this medication by mouth as directed by your doctor,||
2183|028|H|usually twice a day (every 12 hours).||
2183|029|H|   To use, open the packet and sprinkle the contents on 4 ounces||
2183|030|H|(1/2 cup) of applesauce or berry jelly and eat the mixture within||
2183|031|H|30 minutes of preparing it. Or you can sprinkle the contents into||
2183|032|H|4 ounces (1/2 cup) of fruit juice (except for grapefruit juice),||
2183|033|H|stir the mixture gently until mixed, and drink it within 30||
2183|034|H|minutes. Do not crush or chew the mixture or save it for later||
2183|035|H|use.||
2183|036|H|   Taking this medication with other food can affect its||
2183|037|H|absorption. Take this medication on an empty stomach, at least 2||
2183|038|H|hours after or at least 30 minutes before eating food. If you||
2183|039|H|cannot take it without eating, you can eat a small amount of food||
2183|040|H|(4 ounces or 1/2 cup) within 1 hour before and 1 hour after||
2183|041|H|taking this medication. Choose one way to take this medication||
2183|042|H|(either without eating or with a small amount of food) and take||
2183|043|H|it the same way with every dose. Avoid high-fat food close to the||
2183|044|H|time you take your cysteamine dose.||
2183|045|H|   The dosage is based on your weight, medical condition, and||
2183|046|H|response to treatment. To reduce your risk of side effects, your||
2183|047|H|doctor may direct you to start this medication at a low dose and||
2183|048|H|gradually increase your dose. Follow your doctor's instructions||
2183|049|H|carefully.||
2183|050|H|   Do not drink alcohol while you are being treated with this||
2183|051|H|drug. Drinking alcohol may increase the amount of this medication||
2183|052|H|in your body, which may cause serious side effects.||
2183|053|H|   Take this medication regularly to get the most benefit from||
2183|054|H|it. To help you remember, take it at the same times each day.||
2183|055|B|||
2183|056|S|SIDE EFFECTS:  Nausea, vomiting, stomach/abdominal pain, fever,||
2183|057|S|loss of appetite, bad breath, tiredness, drowsiness, dizziness,||
2183|058|S|or diarrhea may occur. If any of these effects last or get worse,||
2183|059|S|tell your doctor or pharmacist promptly.||
2183|060|S|   Remember that this medication has been prescribed because your||
2183|061|S|doctor has judged that the benefit to you is greater than the||
2183|062|S|risk of side effects. Many people using this medication do not||
2183|063|S|have serious side effects.||
2183|064|S|   Tell your doctor right away if you have any serious side||
2183|065|S|effects, including: mental/mood changes (such as confusion,||
2183|066|S|depression, lack of concentration), unusually deep sleep, unusual||
2183|067|S|tiredness, headache, hearing problems (such as buzzing/ringing in||
2183|068|S|the ears), eye/vision problems (such as blurred vision, loss of||
2183|069|S|vision, eye pain), skin problems (such as thinning of the skin,||
2183|070|S|fragile skin, stretch marks, easy bruising), bone problems (such||
2183|071|S|as bone/joint/back pain, leg pain, broken bones, overly flexible||
2183|072|S|joints).||
2183|073|S|   Get medical help right away if you have any very serious side||
2183|074|S|effects, including: seizures, severe/bloody diarrhea, signs of||
2183|075|S|bleeding or ulcers in the stomach/intestines (such as||
2183|076|S|black/bloody stools, severe stomach/abdominal pain, vomit that||
2183|077|S|looks like coffee grounds).||
2183|078|S|   Cysteamine can commonly cause a rash that is usually not||
2183|079|S|serious. However, you may not be able to tell it apart from a||
2183|080|S|rare rash that could be a sign of a severe reaction. Get medical||
2183|081|S|help right away if you develop any rash.||
2183|082|S|   A very serious allergic reaction to this drug is rare.||
2183|083|S|However, get medical help right away if you notice any symptoms||
2183|084|S|of a serious allergic reaction, including: rash, itching/swelling||
2183|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2183|086|S|breathing.||
2183|087|S|   This is not a complete list of possible side effects. If you||
2183|088|S|notice other effects not listed above, contact your doctor or||
2183|089|S|pharmacist.||
2183|090|S|   In the US -||
2183|091|S|   Call your doctor for medical advice about side effects. You||
2183|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2183|093|S|www.fda.gov/medwatch.||
2183|094|S|   In Canada - Call your doctor for medical advice about side||
2183|095|S|effects. You may report side effects to Health Canada at||
2183|096|S|1-866-234-2345.||
2183|097|B|||
2183|098|P|PRECAUTIONS:  Before taking cysteamine, tell your doctor or||
2183|099|P|pharmacist if you are allergic to it; or to penicillamine; or if||
2183|100|P|you have any other allergies. This product may contain inactive||
2183|101|P|ingredients, which can cause allergic reactions or other||
2183|102|P|problems. Talk to your pharmacist for more details.||
2183|103|P|   Before using this medication, tell your doctor or pharmacist||
2183|104|P|your or your child's medical history, especially of: liver||
2183|105|P|disease, stomach/intestine problems (such as bleeding, ulcers),||
2183|106|P|low white blood cell count.||
2183|107|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2183|108|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2183|109|P|machinery, or do anything that needs alertness until you can do||
2183|110|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2183|111|P|are using marijuana (cannabis).||
2183|112|P|   Before having surgery, tell your doctor or dentist about all||
2183|113|P|the products you use (including prescription drugs,||
2183|114|P|nonprescription drugs, and herbal products).||
2183|115|P|   During pregnancy, this medication should be used only when||
2183|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
2183|117|P|   It is unknown if this medication passes into breast milk.||
2183|118|P|Consult your doctor before breastfeeding.||
2183|119|B|||
2183|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2183|121|I|medications work or increase your risk for serious side effects.||
2183|122|I|This document does not contain all possible drug interactions.||
2183|123|I|Keep a list of all the products you use (including||
2183|124|I|prescription/nonprescription drugs and herbal products) and share||
2183|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
2183|126|I|the dosage of any medicines without your doctor's approval.||
2183|127|I|   Products that contain bicarbonate or carbonate may decrease||
2183|128|I|the effect of this medication if taken at the same time. If you||
2183|129|I|are also taking a product that contains bicarbonate or carbonate,||
2183|130|I|separate the time that you take a dose by at least one hour||
2183|131|I|before or after the time that you take cysteamine delayed-release||
2183|132|I|granules.||
2183|133|B|||
2183|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2183|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2183|136|O|poison control center right away. US residents can call||
2183|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2183|138|B|||
2183|139|N|NOTES:  Do not share this medication with others.||
2183|140|N|   Lab and/or medical tests (such as cystine or cysteamine||
2183|141|N|levels, complete blood count, kidney/liver tests) should be done||
2183|142|N|while you are taking this medication. Keep all medical and lab||
2183|143|N|appointments. Consult your doctor for more details.||
2183|144|B|||
2183|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2183|146|D|remember. If it is less than 4 hours before the next dose, skip||
2183|147|D|the missed dose. Take your next dose at the regular time. Do not||
2183|148|D|double the dose to catch up.||
2183|149|B|||
2183|150|R|STORAGE:  Store at room temperature away from light and moisture.||
2183|151|R|Do not open packet until you are ready to use the medication. Do||
2183|152|R|not store in the bathroom. Keep all medications away from||
2183|153|R|children and pets.||
2183|154|R|   Do not flush medications down the toilet or pour them into a||
2183|155|R|drain unless instructed to do so. Properly discard this product||
2183|156|R|when it is expired or no longer needed. Consult your pharmacist||
2183|157|R|or local waste disposal company.||
2183|158|B|||
2183|159|A|Information last revised September 2024.||
2183|160|A|Copyright(c) 2025 First Databank, Inc.||
2183|161|B|||
2184|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2184|002|Z|does NOT have all possible information about this product. This||
2184|003|Z|information does not assure that this product is safe, effective,||
2184|004|Z|or appropriate for you. This information is not individual||
2184|005|Z|medical advice and does not substitute for the advice of your||
2184|006|Z|health care professional. Always ask your health care||
2184|007|Z|professional for complete information about this product and your||
2184|008|Z|specific health needs.||
2184|009|B|||
2184|010|T|CETIRIZINE - OPHTHALMIC||
2184|011|F|(se-TIR-i-zeen)||
2184|012|B|||
2184|013|C|COMMON BRAND NAME(S): Zerviate||
2184|014|B|||
2184|015|U|USES:  This medication is used to prevent itching of the eyes due||
2184|016|U|to allergies. Cetirizine is an antihistamine. It works by||
2184|017|U|blocking a certain natural substance (histamine) that causes||
2184|018|U|allergic symptoms.||
2184|019|U|   Do not use this medication to treat red or irritated eyes due||
2184|020|U|to wearing contact lenses. Contact your doctor for further||
2184|021|U|instructions if this occurs.||
2184|022|B|||
2184|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
2184|024|H|directed by your doctor, usually twice daily (about 8 hours||
2184|025|H|apart).||
2184|026|H|   To apply eye drops, wash hands first. To avoid contamination,||
2184|027|H|do not touch the dropper tip or let it touch your eye or any||
2184|028|H|other surface.||
2184|029|H|   If you are wearing contact lenses, remove them before using||
2184|030|H|eye drops. Wait at least 10 minutes before replacing your contact||
2184|031|H|lenses. Do not wear contact lenses if your eyes are red.||
2184|032|H|   Do not open the single-use container until just before you are||
2184|033|H|ready to use it. After use, throw away the remaining contents of||
2184|034|H|the container right away.||
2184|035|H|   Tilt your head back, look upward, and pull down the lower||
2184|036|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2184|037|H|and place one drop into the pouch as directed by your doctor.||
2184|038|H|Look downward, gently close your eyes, and place one finger at||
2184|039|H|the corner of your eye (near the nose). Apply gentle pressure for||
2184|040|H|1 to 2 minutes before opening your eyes. This will prevent the||
2184|041|H|medication from draining out. Try not to blink or rub your eye.||
2184|042|H|If directed to use this medication in both eyes, repeat these||
2184|043|H|steps for your other eye.||
2184|044|H|   If you are using another kind of eye medication (such as other||
2184|045|H|drops or ointments), wait at least 5 minutes before applying||
2184|046|H|other medications. Use eye drops before eye ointments to allow||
2184|047|H|the drops to enter the eye.||
2184|048|H|   Wait several minutes for your vision to clear before driving||
2184|049|H|or operating machinery.||
2184|050|H|   Use this medication regularly to get the most benefit from it.||
2184|051|H|To help you remember, use it at the same times each day.||
2184|052|H|   Do not use this product if it becomes contaminated (for||
2184|053|H|example, if drops turn a dark color). Using contaminated eye||
2184|054|H|medication can cause infection, serious damage to the eye, or||
2184|055|H|loss of vision. Contact your doctor or pharmacist for more||
2184|056|H|information.||
2184|057|H|   Tell your doctor if your condition does not get better in a||
2184|058|H|few days or if it gets worse.||
2184|059|B|||
2184|060|S|SIDE EFFECTS:  Mild and temporary burning/stinging of the eyes||
2184|061|S|may occur when you apply this medication. If this effect lasts or||
2184|062|S|gets worse, tell your doctor or pharmacist promptly.||
2184|063|S|   Remember that this medication has been prescribed because your||
2184|064|S|doctor has judged that the benefit to you is greater than the||
2184|065|S|risk of side effects. Many people using this medication do not||
2184|066|S|have serious side effects.||
2184|067|S|   A very serious allergic reaction to this drug is rare.||
2184|068|S|However, get medical help right away if you notice any symptoms||
2184|069|S|of a serious allergic reaction, including: rash, itching/swelling||
2184|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2184|071|S|breathing.||
2184|072|S|   This is not a complete list of possible side effects. If you||
2184|073|S|notice other effects not listed above, contact your doctor or||
2184|074|S|pharmacist.||
2184|075|S|   In the US -||
2184|076|S|   Call your doctor for medical advice about side effects. You||
2184|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2184|078|S|www.fda.gov/medwatch.||
2184|079|S|   In Canada - Call your doctor for medical advice about side||
2184|080|S|effects. You may report side effects to Health Canada at||
2184|081|S|1-866-234-2345.||
2184|082|B|||
2184|083|P|PRECAUTIONS:  Before using cetirizine, tell your doctor or||
2184|084|P|pharmacist if you are allergic to it; or if you have any other||
2184|085|P|allergies. This product may contain inactive ingredients, which||
2184|086|P|can cause allergic reactions or other problems. Talk to your||
2184|087|P|pharmacist for more details.||
2184|088|P|   Before using this medication, tell your doctor or pharmacist||
2184|089|P|your medical history.||
2184|090|P|   After you apply this drug, your vision may become temporarily||
2184|091|P|blurred. Do not drive, use machinery, or do anything that needs||
2184|092|P|clear vision until you can do it safely.||
2184|093|P|   Before having surgery, tell your doctor or dentist about all||
2184|094|P|the products you use (including prescription drugs,||
2184|095|P|nonprescription drugs, and herbal products).||
2184|096|P|   During pregnancy, this medication should be used only when||
2184|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
2184|098|P|   It is unknown if this drug passes into breast milk. Consult||
2184|099|P|your doctor before breastfeeding.||
2184|100|B|||
2184|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2184|102|I|medications work or increase your risk for serious side effects.||
2184|103|I|This document does not contain all possible drug interactions.||
2184|104|I|Keep a list of all the products you use (including||
2184|105|I|prescription/nonprescription drugs and herbal products) and share||
2184|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
2184|107|I|the dosage of any medicines without your doctor's approval.||
2184|108|B|||
2184|109|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2184|110|O|has overdosed and has serious symptoms such as passing out or||
2184|111|O|trouble breathing, call 911. Otherwise, call a poison control||
2184|112|O|center right away. US residents can call 1-800-222-1222. Canada||
2184|113|O|residents can call 1-844-764-7669.||
2184|114|B|||
2184|115|N|NOTES:  Do not share this medication with others.||
2184|116|N|   Ask your doctor about ways to reduce your symptoms even more||
2184|117|N|(such as using cold compresses and lubricating eye drops, and||
2184|118|N|avoiding allergens).||
2184|119|B|||
2184|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2184|121|D|If it is near the time of the next dose, skip the missed dose.||
2184|122|D|Use your next dose at the regular time. Do not double the dose to||
2184|123|D|catch up.||
2184|124|B|||
2184|125|R|STORAGE:  Store at room temperature. Keep the medication in the||
2184|126|R|original foil pouch to protect it from light. Keep all||
2184|127|R|medications away from children and pets.||
2184|128|R|   Do not flush medications down the toilet or pour them into a||
2184|129|R|drain unless instructed to do so. Properly discard this product||
2184|130|R|when it is expired or no longer needed. Consult your pharmacist||
2184|131|R|or local waste disposal company.||
2184|132|B|||
2184|133|A|Information last revised July 2024.||
2184|134|A|Copyright(c) 2025 First Databank, Inc.||
2184|135|B|||
2186|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2186|002|Z|does NOT have all possible information about this product. This||
2186|003|Z|information does not assure that this product is safe, effective,||
2186|004|Z|or appropriate for you. This information is not individual||
2186|005|Z|medical advice and does not substitute for the advice of your||
2186|006|Z|health care professional. Always ask your health care||
2186|007|Z|professional for complete information about this product and your||
2186|008|Z|specific health needs.||
2186|009|B|||
2186|010|T|DICLOFENAC/MISOPROSTOL - ORAL||
2186|011|F|(dye-KLOE-fen-ak/MYE-soe-PROS-tol)||
2186|012|B|||
2186|013|C|COMMON BRAND NAME(S): Arthrotec||
2186|014|B|||
2186|015|W|WARNING:  This medication is a combination of 2 drugs: diclofenac||
2186|016|W|and misoprostol. Do not take this medication if you are pregnant||
2186|017|W|or think that you may be pregnant. Misoprostol may cause loss of||
2186|018|W|pregnancy, premature birth, or birth defects. In rare cases,||
2186|019|W|serious problems (such as uterine rupture) have occurred when||
2186|020|W|misoprostol was used to start labor or to end a pregnancy. These||
2186|021|W|problems have caused harm to the mother and unborn baby. The risk||
2186|022|W|for uterine rupture increases as your pregnancy advances and if||
2186|023|W|you had prior uterine surgery (including Cesarean delivery) or if||
2186|024|W|you had five or more previous pregnancies.||
2186|025|W|   Avoid pregnancy while taking this medication and for at least||
2186|026|W|one month or one complete menstrual cycle after you have stopped||
2186|027|W|treatment. If you become pregnant while taking this medication,||
2186|028|W|contact your doctor right away.||
2186|029|W|   If you are of a woman of childbearing age, do not use this||
2186|030|W|medication unless you need a nonsteroidal anti-inflammatory drug||
2186|031|W|(NSAID) such as diclofenac and you are at high risk of having an||
2186|032|W|ulcer or ulcer complications from NSAID treatment.||
2186|033|W|   Female patients must meet the following four requirements in||
2186|034|W|order to use this drug: 1) test negative for pregnancy within 2||
2186|035|W|weeks before starting treatment; 2) use effective birth control||
2186|036|W|to prevent pregnancy; 3) receive oral and written warnings on the||
2186|037|W|dangers of using misoprostol while of childbearing age and the||
2186|038|W|risks of possible birth control failure; 4) start taking this||
2186|039|W|medication only on the second or third day of the next normal||
2186|040|W|menstrual period.||
2186|041|W|   This medication must not be shared with others.||
2186|042|W|   Nonsteroidal anti-inflammatory drugs (including diclofenac)||
2186|043|W|may rarely increase the risk for a heart attack or stroke. This||
2186|044|W|effect can happen at any time while taking this drug but is more||
2186|045|W|likely if you take it for a long time. The risk may be greater in||
2186|046|W|older adults or if you have heart disease or increased risk for||
2186|047|W|heart disease (for example, due to smoking, family history of||
2186|048|W|heart disease, or conditions such as high blood pressure or||
2186|049|W|diabetes). Do not take this drug right before or after heart||
2186|050|W|bypass surgery (CABG).||
2186|051|W|   Also, diclofenac may rarely cause serious (rarely fatal)||
2186|052|W|bleeding from the stomach or intestines. This effect can occur||
2186|053|W|without warning symptoms at any time while taking this drug.||
2186|054|W|Older adults may be at higher risk for this effect.||
2186|055|W|   Stop taking this medication and get medical help right away if||
2186|056|W|you notice any of these rare but serious side effects:||
2186|057|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
2186|058|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
2186|059|W|shortness of breath, unusual sweating, confusion, weakness on one||
2186|060|W|side of the body, trouble speaking, sudden vision changes.||
2186|061|W|   Talk to your doctor or pharmacist about the benefits and risks||
2186|062|W|of taking this drug.||
2186|063|B|||
2186|064|U|USES:  Diclofenac is used to reduce pain, swelling, and joint||
2186|065|U|stiffness from arthritis. Diclofenac is known as a nonsteroidal||
2186|066|U|anti-inflammatory drug (NSAID). Misoprostol protects the stomach||
2186|067|U|from diclofenac's irritating effects. This combination medication||
2186|068|U|is used to treat arthritis in people at high risk of getting||
2186|069|U|stomach/intestinal ulcers and complications from the ulcers (such||
2186|070|U|as bleeding).||
2186|071|U|   If you are treating a chronic condition such as arthritis, ask||
2186|072|U|your doctor about non-drug treatments and/or using other||
2186|073|U|medications to treat your pain. See also Warning section.||
2186|074|B|||
2186|075|V|OTHER USES:  This section contains uses of this drug that are not||
2186|076|V|listed in the approved professional labeling for the drug but||
2186|077|V|that may be prescribed by your health care professional. Use this||
2186|078|V|drug for a condition that is listed in this section only if it||
2186|079|V|has been so prescribed by your health care professional.||
2186|080|V|   This drug may also be used for gout attacks or ankylosing||
2186|081|V|spondylitis in people at a high risk of stomach bleeding or an||
2186|082|V|ulcer.||
2186|083|B|||
2186|084|H|HOW TO USE:  Read the Medication Guide provided by your||
2186|085|H|pharmacist before you start using this medication and each time||
2186|086|H|you get a refill. If you have any questions, ask your doctor or||
2186|087|H|pharmacist.||
2186|088|H|   Take this medication by mouth with a full glass of water (8||
2186|089|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
2186|090|H|Do not lie down for at least 10 minutes after taking this||
2186|091|H|medication.||
2186|092|H|   Swallow the tablets whole. Do not crush, chew, or dissolve the||
2186|093|H|tablets. Doing so can increase the risk of side effects. Do not||
2186|094|H|take tablets that are broken.||
2186|095|H|   Take this medication with food to prevent stomach upset and to||
2186|096|H|reduce the chances of diarrhea. Avoid taking antacids that||
2186|097|H|contain magnesium while using this medication because they may||
2186|098|H|worsen diarrhea. If you need an antacid, consult your doctor or||
2186|099|H|pharmacist to help you choose a product.||
2186|100|H|   The dosage is based on your medical condition, response to||
2186|101|H|treatment, and other medications you may be taking. Be sure to||
2186|102|H|tell your doctor and pharmacist about all the products you use||
2186|103|H|(including prescription drugs, nonprescription drugs, and herbal||
2186|104|H|products). To reduce your risk of stomach bleeding and other side||
2186|105|H|effects, take this medication at the lowest effective dose for||
2186|106|H|the shortest possible time. Do not increase your dose or use this||
2186|107|H|drug more often or for longer than prescribed. For ongoing||
2186|108|H|conditions such as arthritis, keep taking this medication as||
2186|109|H|directed. Discuss the risks and benefits with your doctor or||
2186|110|H|pharmacist.||
2186|111|H|   Use this medication regularly to get the most benefit from it.||
2186|112|H|To help you remember, take it at the same times each day. It may||
2186|113|H|take up to 2 weeks of taking this drug regularly before you get||
2186|114|H|the full benefit.||
2186|115|H|   Tell your doctor if your condition does not get better or if||
2186|116|H|it gets worse.||
2186|117|B|||
2186|118|S|SIDE EFFECTS:  See also Warning section.||
2186|119|S|   Diarrhea and stomach/abdominal pain may occur within a few||
2186|120|S|weeks after you start taking this medication, and usually last||
2186|121|S|for about one week. Nausea, heartburn, gas, upset stomach,||
2186|122|S|drowsiness, and dizziness may also occur. If any of these effects||
2186|123|S|last or get worse, tell your doctor or pharmacist promptly.||
2186|124|S|   Remember that this medication has been prescribed because your||
2186|125|S|doctor has judged that the benefit to you is greater than the||
2186|126|S|risk of side effects. Many people using this medication do not||
2186|127|S|have serious side effects.||
2186|128|S|   This medication may raise your blood pressure. Check your||
2186|129|S|blood pressure regularly and tell your doctor if the results are||
2186|130|S|high.||
2186|131|S|   Diarrhea that is severe or doesn't stop may result in||
2186|132|S|dehydration. Contact your doctor promptly if you notice any||
2186|133|S|symptoms of dehydration, such as unusual dry mouth/thirst, fast||
2186|134|S|heartbeat, or dizziness/lightheadedness.||
2186|135|S|   Tell your doctor right away if you have any serious side||
2186|136|S|effects, including: difficult/painful swallowing, hearing changes||
2186|137|S|(such as ringing in the ears), mental/mood changes (such as||
2186|138|S|depression), easy bruising/bleeding, unusual/heavy vaginal||
2186|139|S|bleeding, menstrual problems/irregular periods, signs of kidney||
2186|140|S|problems (such as change in the amount of urine), symptoms of||
2186|141|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
2186|142|S|unusual/sudden weight gain).||
2186|143|S|   This drug may rarely cause serious (possibly fatal) liver||
2186|144|S|disease. Get medical help right away if you have any symptoms of||
2186|145|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
2186|146|S|of appetite, severe stomach/abdominal pain, yellowing eyes/skin,||
2186|147|S|dark urine.||
2186|148|S|   A very serious allergic reaction to this drug is rare.||
2186|149|S|However, get medical help right away if you notice any symptoms||
2186|150|S|of a serious allergic reaction, including: fever, swollen lymph||
2186|151|S|nodes, rash, itching/swelling (especially of the||
2186|152|S|face/tongue/throat), severe dizziness, trouble breathing.||
2186|153|S|   This is not a complete list of possible side effects. If you||
2186|154|S|notice other effects not listed above, contact your doctor or||
2186|155|S|pharmacist.||
2186|156|S|   In the US -||
2186|157|S|   Call your doctor for medical advice about side effects. You||
2186|158|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2186|159|S|www.fda.gov/medwatch.||
2186|160|S|   In Canada - Call your doctor for medical advice about side||
2186|161|S|effects. You may report side effects to Health Canada at||
2186|162|S|1-866-234-2345.||
2186|163|B|||
2186|164|P|PRECAUTIONS:  See also Warning section.||
2186|165|P|   Before taking this medication, tell your doctor or pharmacist||
2186|166|P|if you are allergic to diclofenac or misoprostol; or to aspirin||
2186|167|P|or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if||
2186|168|P|you have any other allergies. This product may contain inactive||
2186|169|P|ingredients, which can cause allergic reactions or other||
2186|170|P|problems. Talk to your pharmacist for more details.||
2186|171|P|   Before using this medication, tell your doctor or pharmacist||
2186|172|P|your medical history, especially of: liver disease,||
2186|173|P|stomach/intestinal/esophagus problems (such as bleeding,||
2186|174|P|heartburn, ulcers), heart disease (such as previous heart||
2186|175|P|attack), high blood pressure, stroke, swelling (edema, fluid||
2186|176|P|retention), blood disorders (such as anemia), bleeding/clotting||
2186|177|P|problems, asthma (including a history of worsening breathing||
2186|178|P|after taking aspirin or other NSAIDs), growths in the nose (nasal||
2186|179|P|polyps).||
2186|180|P|   Kidney problems can sometimes occur with the use of NSAID||
2186|181|P|medications, including diclofenac. Problems are more likely to||
2186|182|P|occur if you are dehydrated, have heart failure or kidney||
2186|183|P|disease, are an older adult, or if you take certain medications||
2186|184|P|(see also Drug Interactions section). Drink plenty of fluids as||
2186|185|P|directed by your doctor to prevent dehydration and tell your||
2186|186|P|doctor right away if you have a change in the amount of urine.||
2186|187|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2186|188|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2186|189|P|machinery, or do anything that needs alertness until you can do||
2186|190|P|it safely. Talk to your doctor if you are using marijuana||
2186|191|P|(cannabis).||
2186|192|P|   Diclofenac may cause stomach bleeding. Daily use of alcohol||
2186|193|P|and tobacco, especially when combined with this medicine, may||
2186|194|P|increase your risk for stomach bleeding. Limit alcohol and stop||
2186|195|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
2186|196|P|may safely drink.||
2186|197|P|   This medication may make you more sensitive to the sun. Limit||
2186|198|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2186|199|P|sunscreen and wear protective clothing when outdoors. Tell your||
2186|200|P|doctor right away if you get sunburned or have skin||
2186|201|P|blisters/redness.||
2186|202|P|   Before having surgery, tell your doctor or dentist about all||
2186|203|P|the products you use (including prescription drugs,||
2186|204|P|nonprescription drugs, and herbal products).||
2186|205|P|   Older adults may be at greater risk for stomach/intestinal||
2186|206|P|bleeding, kidney problems, heart attack, and stroke while using||
2186|207|P|this drug.||
2186|208|P|   This medication must not be used during pregnancy. It may harm||
2186|209|P|the mother and unborn baby. Use reliable forms of birth control||
2186|210|P|to prevent pregnancy while taking this medication and for at||
2186|211|P|least one month or one completed menstrual cycle after stopping||
2186|212|P|treatment. If you become pregnant or think you may be pregnant,||
2186|213|P|tell your doctor right away.||
2186|214|P|   This medication passes into breast milk but is unlikely to||
2186|215|P|harm a nursing infant. Consult your doctor before breastfeeding.||
2186|216|B|||
2186|217|I|DRUG INTERACTIONS:  See also How to Use section.||
2186|218|I|   Drug interactions may change how your medications work or||
2186|219|I|increase your risk for serious side effects. This document does||
2186|220|I|not contain all possible drug interactions. Keep a list of all||
2186|221|I|the products you use (including prescription/nonprescription||
2186|222|I|drugs and herbal products) and share it with your doctor and||
2186|223|I|pharmacist. Do not start, stop, or change the dosage of any||
2186|224|I|medicines without your doctor's approval.||
2186|225|I|   Some products that may interact with this drug include:||
2186|226|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
2186|227|I|angiotensin II receptor blockers (such as valsartan, losartan),||
2186|228|I|cidofovir, corticosteroids (such as dexamethasone, prednisone),||
2186|229|I|lithium, methotrexate, "water pills" (diuretics such as||
2186|230|I|furosemide).||
2186|231|I|   This medication may increase the risk of bleeding when taken||
2186|232|I|with other drugs that also may cause bleeding. Examples include||
2186|233|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2186|234|I|dabigatran/enoxaparin/warfarin, among others.||
2186|235|I|   Check all prescription and nonprescription medicine labels||
2186|236|I|carefully since many medications contain pain relievers/fever||
2186|237|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
2186|238|I|ketorolac). These drugs are similar to diclofenac and may||
2186|239|I|increase your risk of side effects if taken together. However, if||
2186|240|I|your doctor has told you to take low-dose aspirin to prevent||
2186|241|I|heart attack or stroke (usually 81-162 milligrams a day), you||
2186|242|I|should keep taking the aspirin unless your doctor tells you not||
2186|243|I|to. Ask your doctor or pharmacist for more details.||
2186|244|B|||
2186|245|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2186|246|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2186|247|O|poison control center right away. US residents can call||
2186|248|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2186|249|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
2186|250|O|severe stomach pain, severe drowsiness, slow/shallow breathing,||
2186|251|O|seizures.||
2186|252|B|||
2186|253|N|NOTES:  Do not share this medication with others.||
2186|254|N|   Lab and/or medical tests (such as complete blood count,||
2186|255|N|liver/kidney function, blood pressure) may be done while you are||
2186|256|N|using this medication. Keep all medical and lab appointments.||
2186|257|N|Consult your doctor for more details.||
2186|258|N|   Lifestyle changes (such as weight loss if needed,||
2186|259|N|strengthening/conditioning exercises) may help improve your||
2186|260|N|flexibility and joint function. Consult your doctor for specific||
2186|261|N|instructions.||
2186|262|B|||
2186|263|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2186|264|D|remember. If it is near the time of the next dose, skip the||
2186|265|D|missed dose. Take your next dose at the regular time. Do not||
2186|266|D|double the dose to catch up.||
2186|267|B|||
2186|268|R|STORAGE:  Store at room temperature away from light and moisture.||
2186|269|R|Do not store in the bathroom. Keep all medications away from||
2186|270|R|children and pets.||
2186|271|R|   Do not flush medications down the toilet or pour them into a||
2186|272|R|drain unless instructed to do so. Properly discard this product||
2186|273|R|when it is expired or no longer needed. Consult your pharmacist||
2186|274|R|or local waste disposal company.||
2186|275|B|||
2186|276|A|Information last revised November 2025.||
2186|277|A|Copyright(c) 2025 First Databank, Inc.||
2186|278|B|||
2187|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2187|002|Z|does NOT have all possible information about this product. This||
2187|003|Z|information does not assure that this product is safe, effective,||
2187|004|Z|or appropriate for you. This information is not individual||
2187|005|Z|medical advice and does not substitute for the advice of your||
2187|006|Z|health care professional. Always ask your health care||
2187|007|Z|professional for complete information about this product and your||
2187|008|Z|specific health needs.||
2187|009|B|||
2187|010|T|BETAINE - ORAL||
2187|011|F|(BEE-ta-een)||
2187|012|B|||
2187|013|C|COMMON BRAND NAME(S): Cystadane||
2187|014|B|||
2187|015|U|USES:  This medication is used to treat high levels of a certain||
2187|016|U|important body chemical (homocysteine) due to an inherited||
2187|017|U|disorder (homocystinuria). Decreasing high homocysteine levels||
2187|018|U|may help prevent serious blood clots, abnormal bone formation,||
2187|019|U|brittle bones (osteoporosis), and eye problems (such as||
2187|020|U|dislocated eye lens, nearsightedness). This medication works by||
2187|021|U|decreasing blood levels of homocysteine. It does not correct the||
2187|022|U|inherited disorder that causes the disease.||
2187|023|B|||
2187|024|H|HOW TO USE:  Take this medication by mouth as directed by your||
2187|025|H|doctor, usually twice daily. Shake the bottle lightly before each||
2187|026|H|use. Using the scoop provided, measure out the number of scoops||
2187|027|H|prescribed by your doctor. Mix the powder with 4 to 6 ounces (120||
2187|028|H|to 180 milliliters) of water, juice, milk, or formula until||
2187|029|H|dissolved, and drink immediately. The powder may also be mixed||
2187|030|H|with food instead of liquid and taken immediately. Replace cap||
2187|031|H|tightly after use.||
2187|032|H|   The dosage is based on your age, weight, medical condition,||
2187|033|H|and response to treatment. Use this medication regularly to get||
2187|034|H|the most benefit from it. To help you remember, take it at the||
2187|035|H|same times each day.||
2187|036|H|   Tell your doctor if your condition lasts or gets worse.||
2187|037|B|||
2187|038|S|SIDE EFFECTS:  Nausea, stomach upset, or diarrhea may occur. If||
2187|039|S|any of these effects last or get worse, tell your doctor or||
2187|040|S|pharmacist promptly.||
2187|041|S|   Remember that this medication has been prescribed because your||
2187|042|S|doctor has judged that the benefit to you is greater than the||
2187|043|S|risk of side effects. Many people using this medication do not||
2187|044|S|have serious side effects.||
2187|045|S|   Tell your doctor right away if you have any serious side||
2187|046|S|effects, including: headache that doesn't go away, vision||
2187|047|S|changes.||
2187|048|S|   A very serious allergic reaction to this drug is rare.||
2187|049|S|However, get medical help right away if you notice any symptoms||
2187|050|S|of a serious allergic reaction, including: rash, itching/swelling||
2187|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2187|052|S|breathing.||
2187|053|S|   This is not a complete list of possible side effects. If you||
2187|054|S|notice other effects not listed above, contact your doctor or||
2187|055|S|pharmacist.||
2187|056|S|   In the US -||
2187|057|S|   Call your doctor for medical advice about side effects. You||
2187|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2187|059|S|www.fda.gov/medwatch.||
2187|060|S|   In Canada - Call your doctor for medical advice about side||
2187|061|S|effects. You may report side effects to Health Canada at||
2187|062|S|1-866-234-2345.||
2187|063|B|||
2187|064|P|PRECAUTIONS:  Before taking betaine, tell your doctor or||
2187|065|P|pharmacist if you are allergic to it; or if you have any other||
2187|066|P|allergies. This product may contain inactive ingredients, which||
2187|067|P|can cause allergic reactions or other problems. Talk to your||
2187|068|P|pharmacist for more details.||
2187|069|P|   Before using this medication, tell your doctor or pharmacist||
2187|070|P|your medical history, especially of: high methionine levels||
2187|071|P|(hypermethioninemia).||
2187|072|P|   During pregnancy, this medication should be used only when||
2187|073|P|clearly needed. Discuss the risks and benefits with your doctor.||
2187|074|P|   It is unknown if this medication passes into breast milk.||
2187|075|P|Consult your doctor before breastfeeding.||
2187|076|B|||
2187|077|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2187|078|I|medications work or increase your risk for serious side effects.||
2187|079|I|This document does not contain all possible drug interactions.||
2187|080|I|Keep a list of all the products you use (including||
2187|081|I|prescription/nonprescription drugs and herbal products) and share||
2187|082|I|it with your doctor and pharmacist. Do not start, stop, or change||
2187|083|I|the dosage of any medicines without your doctor's approval.||
2187|084|B|||
2187|085|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2187|086|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2187|087|O|poison control center right away. US residents can call||
2187|088|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2187|089|B|||
2187|090|N|NOTES:  Do not share this medication with others.||
2187|091|N|   Lab and/or medical tests (such as methionine/homocysteine||
2187|092|N|blood levels) may be done while you are taking this medication.||
2187|093|N|Keep all medical and lab appointments. Consult your doctor for||
2187|094|N|more details.||
2187|095|B|||
2187|096|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2187|097|D|remember. If it is near the time of the next dose, skip the||
2187|098|D|missed dose. Take your next dose at the regular time. Do not||
2187|099|D|double the dose to catch up.||
2187|100|B|||
2187|101|R|STORAGE:  Store at room temperature away from light and moisture.||
2187|102|R|Do not store in the bathroom. Keep all medications away from||
2187|103|R|children and pets.||
2187|104|R|   Do not flush medications down the toilet or pour them into a||
2187|105|R|drain unless instructed to do so. Properly discard this product||
2187|106|R|when it is expired or no longer needed. Consult your pharmacist||
2187|107|R|or local waste disposal company.||
2187|108|B|||
2187|109|A|Information last revised June 2024.||
2187|110|A|Copyright(c) 2025 First Databank, Inc.||
2187|111|B|||
2188|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2188|002|Z|does NOT have all possible information about this product. This||
2188|003|Z|information does not assure that this product is safe, effective,||
2188|004|Z|or appropriate for you. This information is not individual||
2188|005|Z|medical advice and does not substitute for the advice of your||
2188|006|Z|health care professional. Always ask your health care||
2188|007|Z|professional for complete information about this product and your||
2188|008|Z|specific health needs.||
2188|009|B|||
2188|010|T|BEMPEDOIC ACID - ORAL||
2188|011|F|(BEM-pe-DOE-ik AS-id)||
2188|012|B|||
2188|013|C|COMMON BRAND NAME(S): Nexletol||
2188|014|B|||
2188|015|U|USES:  Bempedoic acid is used along with a proper diet and other||
2188|016|U|medications to help lower "bad" cholesterol (such as LDL) in the||
2188|017|U|blood. It works by reducing the amount of cholesterol made by the||
2188|018|U|liver. Lowering "bad" cholesterol may help to decrease the risk||
2188|019|U|of heart disease and help prevent strokes and heart attacks.||
2188|020|U|   This medication is also used in people with heart disease or||
2188|021|U|high risk for heart disease to reduce the risk of heart attack or||
2188|022|U|needing heart procedures (such as placing a stent).||
2188|023|U|   In addition to eating a proper diet (such as a||
2188|024|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
2188|025|U|help this medication work better include exercising, losing||
2188|026|U|weight if overweight, and stopping smoking. Consult your doctor||
2188|027|U|for more details.||
2188|028|B|||
2188|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2188|030|H|from your pharmacist before you start taking bempedoic acid and||
2188|031|H|each time you get a refill. If you have any questions, ask your||
2188|032|H|doctor or pharmacist.||
2188|033|H|   Take this medication by mouth with or without food as directed||
2188|034|H|by your doctor, usually once daily.||
2188|035|H|   Take this medication regularly to get the most benefit from||
2188|036|H|it. Remember to use it at the same time each day. Keep taking||
2188|037|H|this medication even if you feel well. Most people with high||
2188|038|H|cholesterol do not feel sick.||
2188|039|H|   It is very important to continue to follow your doctor's||
2188|040|H|advice about diet and exercise. It may take up to 12 weeks before||
2188|041|H|you get the full benefit of this drug.||
2188|042|B|||
2188|043|S|SIDE EFFECTS:  Abdominal pain may occur. If this effect lasts or||
2188|044|S|gets worse, tell your doctor or pharmacist promptly.||
2188|045|S|   Remember that this medication has been prescribed because your||
2188|046|S|doctor has judged that the benefit to you is greater than the||
2188|047|S|risk of side effects. Many people using this medication do not||
2188|048|S|have serious side effects.||
2188|049|S|   Tell your doctor right away if you have any serious side||
2188|050|S|effects, including: toe/joint pain, difficulty urinating (for||
2188|051|S|example, due to enlarged prostate).||
2188|052|S|   Tendon damage may occur during treatment with this medication.||
2188|053|S|Stop exercising, rest, and get medical help right away if you||
2188|054|S|develop joint/muscle/tendon pain or swelling. Your risk for||
2188|055|S|tendon problems is greater if you are over 60 years of age, if||
2188|056|S|you are taking corticosteroids (such as prednisone) or||
2188|057|S|fluoroquinolones (such as ciprofloxacin), or if you have kidney||
2188|058|S|or tendon problems.||
2188|059|S|   A very serious allergic reaction to this drug is rare.||
2188|060|S|However, get medical help right away if you notice any symptoms||
2188|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2188|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2188|063|S|breathing.||
2188|064|S|   This is not a complete list of possible side effects. If you||
2188|065|S|notice other effects not listed above, contact your doctor or||
2188|066|S|pharmacist.||
2188|067|S|   In the US -||
2188|068|S|   Call your doctor for medical advice about side effects. You||
2188|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2188|070|S|www.fda.gov/medwatch.||
2188|071|S|   In Canada - Call your doctor for medical advice about side||
2188|072|S|effects. You may report side effects to Health Canada at||
2188|073|S|1-866-234-2345.||
2188|074|B|||
2188|075|P|PRECAUTIONS:  Before taking bempedoic acid, tell your doctor or||
2188|076|P|pharmacist if you are allergic to it; or if you have any other||
2188|077|P|allergies. This product may contain inactive ingredients, which||
2188|078|P|can cause allergic reactions or other problems. Talk to your||
2188|079|P|pharmacist for more details.||
2188|080|P|   Before using this medication, tell your doctor or pharmacist||
2188|081|P|your medical history, especially of: liver disease, kidney||
2188|082|P|disease, gout, tendon problems.||
2188|083|P|   Before having surgery, tell your doctor or dentist about all||
2188|084|P|the products you use (including prescription drugs,||
2188|085|P|nonprescription drugs, and herbal products).||
2188|086|P|   Older adults may be more sensitive to the side effects of this||
2188|087|P|drug, especially tendon problems.||
2188|088|P|   Tell your doctor if you are pregnant or plan to become||
2188|089|P|pregnant. You should not become pregnant while using bempedoic||
2188|090|P|acid. Bempedoic acid may harm an unborn baby. If you become||
2188|091|P|pregnant, talk to your doctor right away about the risks and||
2188|092|P|benefits of this medication.||
2188|093|P|   This medication passes into breast milk. Because of the||
2188|094|P|possible risk to the infant, breastfeeding is not recommended||
2188|095|P|while using this medication. Consult your doctor before||
2188|096|P|breastfeeding.||
2188|097|B|||
2188|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2188|099|I|medications work or increase your risk for serious side effects.||
2188|100|I|This document does not contain all possible drug interactions.||
2188|101|I|Keep a list of all the products you use (including||
2188|102|I|prescription/nonprescription drugs and herbal products) and share||
2188|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
2188|104|I|the dosage of any medicines without your doctor's approval.||
2188|105|B|||
2188|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2188|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2188|108|O|poison control center right away. US residents can call||
2188|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2188|110|B|||
2188|111|N|NOTES:  Do not share this medication with others.||
2188|112|N|   Lab and/or medical tests (such as kidney/liver function, uric||
2188|113|N|acid levels, complete blood count, cholesterol levels) should be||
2188|114|N|done while you are taking this medication. Keep all medical and||
2188|115|N|lab appointments. Consult your doctor for more details.||
2188|116|B|||
2188|117|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2188|118|D|remember. If it is near the time of the next dose, skip the||
2188|119|D|missed dose. Take your next dose at the regular time. Do not||
2188|120|D|double the dose to catch up.||
2188|121|B|||
2188|122|R|STORAGE:  Store in the original container at room temperature||
2188|123|R|away from light and moisture. Do not store in the bathroom. Keep||
2188|124|R|the drying agent (desiccant) in the bottle. Tightly close the||
2188|125|R|bottle when not in use. Keep all medications away from children||
2188|126|R|and pets.||
2188|127|R|   Do not flush medications down the toilet or pour them into a||
2188|128|R|drain unless instructed to do so. Properly discard this product||
2188|129|R|when it is expired or no longer needed. Consult your pharmacist||
2188|130|R|or local waste disposal company.||
2188|131|B|||
2188|132|A|Information last revised July 2025.||
2188|133|A|Copyright(c) 2025 First Databank, Inc.||
2188|134|B|||
2189|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2189|002|Z|does NOT have all possible information about this product. This||
2189|003|Z|information does not assure that this product is safe, effective,||
2189|004|Z|or appropriate for you. This information is not individual||
2189|005|Z|medical advice and does not substitute for the advice of your||
2189|006|Z|health care professional. Always ask your health care||
2189|007|Z|professional for complete information about this product and your||
2189|008|Z|specific health needs.||
2189|009|B|||
2189|010|T|RIMEGEPANT DISINTEGRATING TABLET - ORAL||
2189|011|F|(ri-ME-je-pant)||
2189|012|B|||
2189|013|C|COMMON BRAND NAME(S): Nurtec ODT||
2189|014|B|||
2189|015|U|USES:  This medication is used to prevent or treat migraine.||
2189|016|U|Rimegepant may work by changing the amount of a certain natural||
2189|017|U|substance in the brain. It helps to relieve headache, pain, and||
2189|018|U|other migraine symptoms (such as nausea, vomiting, sensitivity to||
2189|019|U|light/sound). Prompt treatment helps you return to your normal||
2189|020|U|routine and may decrease your need for other pain medications.||
2189|021|B|||
2189|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2189|023|H|from your pharmacist before you start taking rimegepant and each||
2189|024|H|time you get a refill. If you have any questions, ask your doctor||
2189|025|H|or pharmacist.||
2189|026|H|   For the treatment of migraine, take this medication by mouth||
2189|027|H|as directed by your doctor, at the first sign of a migraine. It||
2189|028|H|is not known if it is safe to take this medication for more than||
2189|029|H|18 migraines within 30 days.||
2189|030|H|   For the prevention of migraine, take this medication by mouth||
2189|031|H|as directed by your doctor, usually once every other day. Use||
2189|032|H|this medication regularly to get the most benefit from it. To||
2189|033|H|help you remember, mark your calendar with a reminder.||
2189|034|H|   This medication comes in a blister pack. When you are ready to||
2189|035|H|take a dose, first make sure your hands are dry. Peel back the||
2189|036|H|foil on the blister pack to carefully remove the tablet. Do not||
2189|037|H|try to push the tablet through the foil because doing so can||
2189|038|H|damage the tablet. Place the tablet either on or under your||
2189|039|H|tongue and allow it to dissolve. After the tablet has melted, it||
2189|040|H|can be swallowed with your saliva. You do not need to take this||
2189|041|H|medication with water or other liquid. Take the tablet right||
2189|042|H|after opening the blister pack. Do not store this medication||
2189|043|H|outside the blister pack for future use.||
2189|044|H|   The dosage is based on your medical condition, response to||
2189|045|H|treatment, and other medications you may be taking. Be sure to||
2189|046|H|tell your doctor and pharmacist about all the products you use||
2189|047|H|(including prescription drugs, nonprescription drugs, and herbal||
2189|048|H|products). Do not take more than 1 tablet in a 24-hour period. If||
2189|049|H|you are taking certain other medications, or if you consume||
2189|050|H|grapefruit or grapefruit juice, do not take more than 1 tablet in||
2189|051|H|a 48-hour period. If you are not sure when it is safe to take||
2189|052|H|another dose, ask your doctor or pharmacist.||
2189|053|H|   Tell your doctor if your migraines happen more often or get||
2189|054|H|worse.||
2189|055|B|||
2189|056|S|SIDE EFFECTS:  Nausea may occur. If this effect lasts or gets||
2189|057|S|worse, tell your doctor or pharmacist promptly.||
2189|058|S|   Remember that this medication has been prescribed because your||
2189|059|S|doctor has judged that the benefit to you is greater than the||
2189|060|S|risk of side effects. Many people using this medication do not||
2189|061|S|have serious side effects.||
2189|062|S|   This medication may raise your blood pressure. Check your||
2189|063|S|blood pressure regularly and tell your doctor if the results are||
2189|064|S|high. Your doctor may control your blood pressure with||
2189|065|S|medication.||
2189|066|S|   Tell your doctor right away if you have any serious side||
2189|067|S|effects, including: blue fingers/toes, cold hands/feet.||
2189|068|S|   A very serious allergic reaction to this drug is rare.||
2189|069|S|However, get medical help right away if you notice any symptoms||
2189|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2189|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2189|072|S|breathing.||
2189|073|S|   This is not a complete list of possible side effects. If you||
2189|074|S|notice other effects not listed above, contact your doctor or||
2189|075|S|pharmacist.||
2189|076|S|   In the US -||
2189|077|S|   Call your doctor for medical advice about side effects. You||
2189|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2189|079|S|www.fda.gov/medwatch.||
2189|080|S|   In Canada - Call your doctor for medical advice about side||
2189|081|S|effects. You may report side effects to Health Canada at||
2189|082|S|1-866-234-2345.||
2189|083|B|||
2189|084|P|PRECAUTIONS:  Before taking rimegepant, tell your doctor or||
2189|085|P|pharmacist if you are allergic to it; or if you have any other||
2189|086|P|allergies. This product may contain inactive ingredients, which||
2189|087|P|can cause allergic reactions or other problems. Talk to your||
2189|088|P|pharmacist for more details.||
2189|089|P|   Before using this medication, tell your doctor or pharmacist||
2189|090|P|your medical history, especially of: blood circulation problems||
2189|091|P|(such as Raynaud's disease), high blood pressure, kidney||
2189|092|P|problems, liver problems.||
2189|093|P|   This medication may contain aspartame. If you have||
2189|094|P|phenylketonuria (PKU) or any other condition that requires you to||
2189|095|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
2189|096|P|doctor or pharmacist about using this medication safely.||
2189|097|P|   Before having surgery, tell your doctor or dentist about all||
2189|098|P|the products you use (including prescription drugs,||
2189|099|P|nonprescription drugs, and herbal products).||
2189|100|P|   During pregnancy, this medication should be used only when||
2189|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
2189|102|P|   This medication passes into breast milk. Consult your doctor||
2189|103|P|before breastfeeding.||
2189|104|B|||
2189|105|I|DRUG INTERACTIONS:  See also How to Use section.||
2189|106|I|   Drug interactions may change how your medications work or||
2189|107|I|increase your risk for serious side effects. This document does||
2189|108|I|not contain all possible drug interactions. Keep a list of all||
2189|109|I|the products you use (including prescription/nonprescription||
2189|110|I|drugs and herbal products) and share it with your doctor and||
2189|111|I|pharmacist. Do not start, stop, or change the dosage of any||
2189|112|I|medicines without your doctor's approval.||
2189|113|I|   Other medications can affect the removal of rimegepant from||
2189|114|I|your body, which may affect how rimegepant works. Examples||
2189|115|I|include azole antifungals (such as ketoconazole, itraconazole),||
2189|116|I|macrolide antibiotics (such as clarithromycin), rifamycins (such||
2189|117|I|as rifampin, rifabutin), St. John's wort, drugs used to treat||
2189|118|I|seizures (such as carbamazepine, phenytoin), among others.||
2189|119|B|||
2189|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2189|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2189|122|O|poison control center right away. US residents can call||
2189|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2189|124|B|||
2189|125|N|NOTES:  Do not share this medication with others.||
2189|126|N|   Certain foods, beverages, or food additives (such as red wine,||
2189|127|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
2189|128|N|patterns such as irregular eating/sleeping habits or stress may||
2189|129|N|bring on a migraine headache. Avoiding these "triggers" may help||
2189|130|N|lessen migraine attacks. Consult your doctor for more details.||
2189|131|N|   Lab and/or medical tests (such as blood pressure) may be done||
2189|132|N|while you are taking this medication. Keep all medical and lab||
2189|133|N|appointments. Consult your doctor for more details.||
2189|134|B|||
2189|135|D|MISSED DOSE:  If you are taking this medication to prevent||
2189|136|D|migraine and you miss a dose, take it as soon as you remember. If||
2189|137|D|it is near the time of the next dose, skip the missed dose. Take||
2189|138|D|your next dose at the regular time. Do not double the dose to||
2189|139|D|catch up.||
2189|140|B|||
2189|141|R|STORAGE:  Store at room temperature away from light and moisture.||
2189|142|R|Do not store in the bathroom. Keep all medications away from||
2189|143|R|children and pets.||
2189|144|R|   Do not flush medications down the toilet or pour them into a||
2189|145|R|drain unless instructed to do so. Properly discard this product||
2189|146|R|when it is expired or no longer needed. Consult your pharmacist||
2189|147|R|or local waste disposal company.||
2189|148|B|||
2189|149|A|Information last revised March 2025.||
2189|150|A|Copyright(c) 2025 First Databank, Inc.||
2189|151|B|||
2190|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2190|002|Z|does NOT have all possible information about this product. This||
2190|003|Z|information does not assure that this product is safe, effective,||
2190|004|Z|or appropriate for you. This information is not individual||
2190|005|Z|medical advice and does not substitute for the advice of your||
2190|006|Z|health care professional. Always ask your health care||
2190|007|Z|professional for complete information about this product and your||
2190|008|Z|specific health needs.||
2190|009|B|||
2190|010|T|ISATUXIMAB - INJECTION||
2190|011|F|(EYE-sa-TUX-i-mab)||
2190|012|B|||
2190|013|C|COMMON BRAND NAME(S): Sarclisa||
2190|014|B|||
2190|015|U|USES:  This medication is used to treat a certain type of cancer||
2190|016|U|(multiple myeloma). Isatuximab belongs to a class of drugs known||
2190|017|U|as monoclonal antibodies. It works by slowing or stopping the||
2190|018|U|growth of cancer cells.||
2190|019|B|||
2190|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2190|021|H|from your pharmacist before you start using isatuximab and each||
2190|022|H|time you receive this medication. If you have any questions, ask||
2190|023|H|your doctor or pharmacist.||
2190|024|H|   This medication is given by injection into a vein by a health||
2190|025|H|care professional. It is given as directed by your doctor on a||
2190|026|H|treatment schedule. Follow your doctor's treatment schedule||
2190|027|H|carefully.||
2190|028|H|   Infusion reactions may happen during the infusion of this drug||
2190|029|H|and within a day afterward. Your doctor may prescribe other||
2190|030|H|medications before each treatment to help prevent these side||
2190|031|H|effects. Tell your doctor right away if you have any symptoms of||
2190|032|H|infusion reactions such as nausea, shortness of breath, cough,||
2190|033|H|headache, or chills.||
2190|034|H|   The dosage is based on your weight and response to treatment.||
2190|035|H|   To get the most benefit, do not miss any doses. To help you||
2190|036|H|remember, mark your calendar with a reminder.||
2190|037|B|||
2190|038|S|SIDE EFFECTS:  See also How to Use section.||
2190|039|S|   Diarrhea, nausea, or vomiting may occur. If any of these||
2190|040|S|effects last or get worse, tell your doctor or pharmacist||
2190|041|S|promptly.||
2190|042|S|   People using this medication may have serious side effects.||
2190|043|S|However, you have been prescribed this drug because your doctor||
2190|044|S|has judged that the benefit to you is greater than the risk of||
2190|045|S|side effects. Careful monitoring by your doctor may decrease your||
2190|046|S|risk.||
2190|047|S|   Tell your doctor right away if you have any serious side||
2190|048|S|effects, including: easy bruising/bleeding, unusual tiredness.||
2190|049|S|   This medication may lower your ability to fight infections.||
2190|050|S|This may make you more likely to get a serious (rarely fatal)||
2190|051|S|infection or make any infection you have worse. Tell your doctor||
2190|052|S|right away if you have any signs of infection (such as sore||
2190|053|S|throat that doesn't go away, fever, chills, cough, shortness of||
2190|054|S|breath).||
2190|055|S|   Some people treated with this medication may rarely get other||
2190|056|S|cancers. Consult your doctor for more details.||
2190|057|S|   A very serious allergic reaction to this drug is rare.||
2190|058|S|However, get medical help right away if you notice any symptoms||
2190|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2190|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2190|061|S|breathing.||
2190|062|S|   This is not a complete list of possible side effects. If you||
2190|063|S|notice other effects not listed above, contact your doctor or||
2190|064|S|pharmacist.||
2190|065|S|   In the US -||
2190|066|S|   Call your doctor for medical advice about side effects. You||
2190|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2190|068|S|www.fda.gov/medwatch.||
2190|069|S|   In Canada - Call your doctor for medical advice about side||
2190|070|S|effects. You may report side effects to Health Canada at||
2190|071|S|1-866-234-2345.||
2190|072|B|||
2190|073|P|PRECAUTIONS:  Before using isatuximab, tell your doctor or||
2190|074|P|pharmacist if you are allergic to it; or if you have any other||
2190|075|P|allergies. This product may contain inactive ingredients, which||
2190|076|P|can cause allergic reactions or other problems. Talk to your||
2190|077|P|pharmacist for more details.||
2190|078|P|   Before using this medication, tell your doctor or pharmacist||
2190|079|P|your medical history, especially of: current/recent infection||
2190|080|P|(such as herpes zoster).||
2190|081|P|   Isatuximab can make you more likely to get infections or may||
2190|082|P|make current infections worse. Stay away from anyone who has an||
2190|083|P|infection that may easily spread (such as chickenpox, COVID-19,||
2190|084|P|measles, flu). Talk to your doctor if you have been exposed to an||
2190|085|P|infection or for more details.||
2190|086|P|   Tell your health care professional that you are using||
2190|087|P|isatuximab before having any immunizations/vaccinations. Avoid||
2190|088|P|contact with people who have recently received live vaccines||
2190|089|P|(such as flu vaccine inhaled through the nose).||
2190|090|P|   To lower the chance of getting cut, bruised, or injured, use||
2190|091|P|caution with sharp objects like razors and nail cutters, and||
2190|092|P|avoid activities such as contact sports.||
2190|093|P|   Before having surgery, tell your doctor or dentist about all||
2190|094|P|the products you use (including prescription drugs,||
2190|095|P|nonprescription drugs, and herbal products).||
2190|096|P|   Tell your doctor if you are pregnant or plan to become||
2190|097|P|pregnant. You should not become pregnant while using isatuximab.||
2190|098|P|Isatuximab may harm an unborn baby. Ask about reliable forms of||
2190|099|P|birth control while using this medication and for 5 months after||
2190|100|P|the last dose. If you become pregnant, talk to your doctor right||
2190|101|P|away about the risks and benefits of this medication.||
2190|102|P|   When isatuximab is used in combination with pomalidomide or||
2190|103|P|lenalidomide, it must not be used during pregnancy. The||
2190|104|P|combination may cause harm (possibly death) to an unborn baby.||
2190|105|P|Talk to your doctor for more details. Females using these||
2190|106|P|medications must use two reliable forms of birth control. Males||
2190|107|P|using these medications must always use a condom during sexual||
2190|108|P|activity. If you or your partner become pregnant, or if you think||
2190|109|P|you or your partner may be pregnant, tell your doctor right away.||
2190|110|P|   It is unknown if this drug passes into breast milk. Because of||
2190|111|P|the possible risk to the infant (especially when using with||
2190|112|P|pomalidomide or lenalidomide), breastfeeding is not recommended||
2190|113|P|while using this drug. Consult your doctor before breastfeeding.||
2190|114|B|||
2190|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2190|116|I|medications work or increase your risk for serious side effects.||
2190|117|I|This document does not contain all possible drug interactions.||
2190|118|I|Keep a list of all the products you use (including||
2190|119|I|prescription/nonprescription drugs and herbal products) and share||
2190|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
2190|121|I|the dosage of any medicines without your doctor's approval.||
2190|122|I|   This medication may interfere with certain lab tests (such as||
2190|123|I|Coombs test), possibly causing false test results during||
2190|124|I|treatment and for about 6 months after the last dose. Make sure||
2190|125|I|lab personnel and all your doctors know you use or have used this||
2190|126|I|drug.||
2190|127|B|||
2190|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2190|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2190|130|O|poison control center right away. US residents can call||
2190|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2190|132|B|||
2190|133|N|NOTES:  Do not share this medication with others.||
2190|134|N|   Lab and/or medical tests (such as complete blood count) should||
2190|135|N|be done before you start using this medication and while you are||
2190|136|N|using it. Keep all medical and lab appointments. Consult your||
2190|137|N|doctor for more details.||
2190|138|B|||
2190|139|D|MISSED DOSE:  It is important to receive each dose of this||
2190|140|D|medication as scheduled. If you miss a dose, ask your doctor or||
2190|141|D|pharmacist right away for a new dosing schedule. Do not double||
2190|142|D|the dose to catch up.||
2190|143|B|||
2190|144|R|STORAGE:  Not applicable. This medication is given in a clinic||
2190|145|R|and will not be stored at home.||
2190|146|B|||
2190|147|M|MEDICAL ALERT:  Your condition can cause complications in a||
2190|148|M|medical emergency. For information about enrolling in MedicAlert,||
2190|149|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2190|150|B|||
2190|151|A|Information last revised October 2024.||
2190|152|A|Copyright(c) 2025 First Databank, Inc.||
2190|153|B|||
2191|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2191|002|Z|does NOT have all possible information about this product. This||
2191|003|Z|information does not assure that this product is safe, effective,||
2191|004|Z|or appropriate for you. This information is not individual||
2191|005|Z|medical advice and does not substitute for the advice of your||
2191|006|Z|health care professional. Always ask your health care||
2191|007|Z|professional for complete information about this product and your||
2191|008|Z|specific health needs.||
2191|009|B|||
2191|010|T|EMPAGLIFLOZIN/LINAGLIPTIN/METFORMIN EXTENDED-RELEASE - ORAL||
2191|011|F|(EM-pa-gli-FLOE-zin/LIN-a-GLIP-tin/met-FOR-min)||
2191|012|B|||
2191|013|C|COMMON BRAND NAME(S): Trijardy XR||
2191|014|B|||
2191|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
2191|016|W|cause a serious (sometimes fatal) condition called lactic||
2191|017|W|acidosis. Lactic acidosis is more likely if you are an older||
2191|018|W|adult, if you have kidney or liver disease, dehydration, heart||
2191|019|W|failure, heavy alcohol use, if you have surgery, if you have||
2191|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
2191|021|W|you are using certain drugs. For some conditions, your doctor may||
2191|022|W|tell you to stop taking this medication for a short time. Ask||
2191|023|W|your doctor or pharmacist for more details.||
2191|024|W|   Stop taking this medication and get medical help right away if||
2191|025|W|you have any symptoms of lactic acidosis, such as unusual||
2191|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
2191|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
2191|028|W|or stomach pain with nausea/vomiting/diarrhea.||
2191|029|B|||
2191|030|U|USES:  This medication is a combination of 3 drugs:||
2191|031|U|empagliflozin, linagliptin, and metformin. It is used with a||
2191|032|U|proper diet and exercise program to control high blood sugar in||
2191|033|U|people with type 2 diabetes. Controlling high blood sugar helps||
2191|034|U|prevent kidney damage, blindness, nerve problems, loss of limbs,||
2191|035|U|and sexual function problems. Proper control of diabetes may also||
2191|036|U|lessen your risk of a heart attack or stroke. This medication||
2191|037|U|works by helping to restore your body's proper response to the||
2191|038|U|insulin you naturally produce. It also works by increasing levels||
2191|039|U|of natural substances called incretins. Incretins help to control||
2191|040|U|blood sugar by increasing insulin release, especially after a||
2191|041|U|meal. This medication also increases the removal of sugar by your||
2191|042|U|kidneys, decreases how much sugar is made in your liver, and||
2191|043|U|decreases how much sugar your body takes in through your stomach||
2191|044|U|and intestines.||
2191|045|B|||
2191|046|H|HOW TO USE:  Read the Medication Guide provided by your||
2191|047|H|pharmacist before you start taking this medication and each time||
2191|048|H|you get a refill. If you have any questions, ask your doctor or||
2191|049|H|pharmacist.||
2191|050|H|   Take this medication by mouth as directed by your doctor,||
2191|051|H|usually once daily with the morning meal. Swallow the tablets||
2191|052|H|whole. Do not crush, dissolve, or chew the tablets. Doing so can||
2191|053|H|release all of the drug at once, increasing the risk of side||
2191|054|H|effects. Take this medication regularly to get the most benefit||
2191|055|H|from it. To help you remember, take it at the same time each day.||
2191|056|H|Drink plenty of fluids while taking this medication unless||
2191|057|H|otherwise directed by your doctor.||
2191|058|H|   The dosage is based on your medical condition, response to||
2191|059|H|treatment, and other medications you may be taking. Be sure to||
2191|060|H|tell your doctor and pharmacist about all the products you use||
2191|061|H|(including prescription drugs, nonprescription drugs, and herbal||
2191|062|H|products). To reduce your risk of side effects (such as diarrhea,||
2191|063|H|nausea), your doctor may direct you to start this medication at a||
2191|064|H|low dose and gradually increase your dose. Follow your doctor's||
2191|065|H|instructions carefully.||
2191|066|H|   Tell your doctor if your condition does not get better or if||
2191|067|H|it gets worse (your blood sugar is too high or too low).||
2191|068|B|||
2191|069|S|SIDE EFFECTS:  See also Warning section.||
2191|070|S|   Nausea, vomiting, stomach upset, diarrhea, bloating/gas,||
2191|071|S|headache, or weakness may occur. If any of these effects last or||
2191|072|S|get worse, tell your doctor or pharmacist promptly. If stomach||
2191|073|S|symptoms return later (after taking the same dose for several||
2191|074|S|days or weeks), tell your doctor right away. Stomach symptoms||
2191|075|S|that occur after the first days of your treatment may be signs of||
2191|076|S|lactic acidosis.||
2191|077|S|   Tell your doctor if you see undissolved tablets in your stool.||
2191|078|S|Your doctor may check lab tests to make sure the medication is||
2191|079|S|working.||
2191|080|S|   Remember that this medication has been prescribed because your||
2191|081|S|doctor has judged that the benefit to you is greater than the||
2191|082|S|risk of side effects. Many people using this medication do not||
2191|083|S|have serious side effects.||
2191|084|S|   Tell your doctor right away if you have any serious side||
2191|085|S|effects, including: signs of a urinary tract infection (such as||
2191|086|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
2191|087|S|signs of kidney problems (such as change in the amount of urine),||
2191|088|S|joint pain, unusual skin blisters, signs of heart failure (such||
2191|089|S|as shortness of breath, swelling ankles/feet, unusual/sudden||
2191|090|S|weight gain).||
2191|091|S|   Get medical help right away if you have any very serious side||
2191|092|S|effects, including: signs of disease of the pancreas (such as||
2191|093|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain||
2191|094|S|which may spread to the back).||
2191|095|S|   This medication may cause a new yeast infection in the vagina||
2191|096|S|or the penis. It may also cause a rare but very serious bacterial||
2191|097|S|infection in the genital/anal area (Fournier's gangrene). Tell||
2191|098|S|your doctor right away if you have signs of a yeast infection in||
2191|099|S|the vagina (such as unusual vaginal||
2191|100|S|discharge/burning/itching/odor) or in the penis (such as||
2191|101|S|redness/itching/swelling of the penis, unusual discharge from the||
2191|102|S|penis). However, get medical help right away if you have any||
2191|103|S|pain/redness/swelling in or around the genital/anal area, along||
2191|104|S|with a fever or feeling unwell.||
2191|105|S|   This medication may increase the risk of lower limb amputation||
2191|106|S|(especially of the toe and foot). The risk is higher if you have||
2191|107|S|poor blood flow in the legs, nerve problems, foot ulcers, or have||
2191|108|S|had a previous amputation. To lessen the risk, check your feet||
2191|109|S|regularly and tell your doctor if you have new pain, tenderness,||
2191|110|S|sores, or ulcers on your legs or feet.||
2191|111|S|   This medication does not usually cause low blood sugar||
2191|112|S|(hypoglycemia). Low blood sugar may occur if this drug is||
2191|113|S|prescribed with other diabetes medications, or if you do not get||
2191|114|S|enough calories from food, or if you do unusually heavy exercise.||
2191|115|S|Talk with your doctor or pharmacist about whether the dose of||
2191|116|S|your other diabetes medication(s) needs to be lowered. Symptoms||
2191|117|S|of low blood sugar include sudden sweating, shaking, fast||
2191|118|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
2191|119|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
2191|120|S|treat low blood sugar. If you don't have these reliable forms of||
2191|121|S|glucose, rapidly raise your blood sugar by eating a quick source||
2191|122|S|of sugar such as table sugar, honey, or candy, or drink fruit||
2191|123|S|juice or non-diet soda. Tell your doctor right away about the||
2191|124|S|reaction and the use of this product. To help prevent low blood||
2191|125|S|sugar, eat meals on a regular schedule, and do not skip meals.||
2191|126|S|Check with your doctor or pharmacist to find out what you should||
2191|127|S|do if you miss a meal.||
2191|128|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
2191|129|S|thirst/urination. If these symptoms occur, tell your doctor right||
2191|130|S|away. Your doctor may need to adjust your diabetes medication,||
2191|131|S|exercise program, or diet.||
2191|132|S|   This medication may cause you to become dehydrated. This can||
2191|133|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
2191|134|S|dehydration. Tell your doctor or pharmacist right away if you are||
2191|135|S|not able to drink fluids as usual, or losing fluid (such as due||
2191|136|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
2191|137|S|right away if you have any signs of dehydration, such as||
2191|138|S|urinating less than usual, unusual dry mouth/thirst, fast||
2191|139|S|heartbeat, or dizziness/lightheadedness/fainting. To reduce the||
2191|140|S|risk of dizziness and lightheadedness, get up slowly when rising||
2191|141|S|from a sitting or lying position.||
2191|142|S|   A very serious allergic reaction to this drug is rare.||
2191|143|S|However, get medical help right away if you notice any symptoms||
2191|144|S|of a serious allergic reaction, including: rash, itching/swelling||
2191|145|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2191|146|S|breathing.||
2191|147|S|   This is not a complete list of possible side effects. If you||
2191|148|S|notice other effects not listed above, contact your doctor or||
2191|149|S|pharmacist.||
2191|150|S|   In the US -||
2191|151|S|   Call your doctor for medical advice about side effects. You||
2191|152|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2191|153|S|www.fda.gov/medwatch.||
2191|154|S|   In Canada - Call your doctor for medical advice about side||
2191|155|S|effects. You may report side effects to Health Canada at||
2191|156|S|1-866-234-2345.||
2191|157|B|||
2191|158|P|PRECAUTIONS:  See also Warning section.||
2191|159|P|   Before taking this medication, tell your doctor or pharmacist||
2191|160|P|if you are allergic to empagliflozin, linagliptin, or metformin;||
2191|161|P|or if you have any other allergies. This product may contain||
2191|162|P|inactive ingredients, which can cause allergic reactions or other||
2191|163|P|problems. Talk to your pharmacist for more details.||
2191|164|P|   Before using this medication, tell your doctor or pharmacist||
2191|165|P|your medical history, especially of: breathing problems (such as||
2191|166|P|asthma, obstructive lung disease), blood problems (such as||
2191|167|P|anemia, vitamin B12 deficiency), dehydration, heart disease (such||
2191|168|P|as heart failure, recent heart attack), kidney disease, liver||
2191|169|P|problems, disease of the pancreas (pancreatitis), stones in your||
2191|170|P|gallbladder (gallstones), use/abuse of alcohol, yeast infections||
2191|171|P|in the vagina or penis, blocked or narrowed blood vessels,||
2191|172|P|usually in the leg, nerve problems (such as diabetic peripheral||
2191|173|P|neuropathy), foot sores or ulcers, amputation.||
2191|174|P|   You may experience blurred vision, dizziness, or drowsiness||
2191|175|P|due to extremely low or high blood sugar. Do not drive, use||
2191|176|P|machinery, or do anything that needs alertness or clear vision||
2191|177|P|until you can do it safely.||
2191|178|P|   Limit alcohol while using this medication because it can||
2191|179|P|increase your risk of developing lactic acidosis, low blood||
2191|180|P|sugar, or a high ketone level.||
2191|181|P|   High fever, "water pills" (diuretics such as||
2191|182|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
2191|183|P|may cause dehydration and increase your risk of lactic acidosis.||
2191|184|P|Stop taking this medication and tell your doctor right away if||
2191|185|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
2191|186|P|fluids to prevent dehydration unless your doctor directs you||
2191|187|P|otherwise.||
2191|188|P|   It may be harder to control your blood sugar when your body is||
2191|189|P|stressed (such as due to fever, infection, injury, or surgery).||
2191|190|P|Also, if you are eating less or not able to eat due to these||
2191|191|P|conditions or any illness, this can lead to a high ketone level||
2191|192|P|while you are taking this medication. Consult your doctor because||
2191|193|P|this may require a change in your treatment plan, medications, or||
2191|194|P|blood sugar or ketone testing.||
2191|195|P|   Before having surgery or any X-ray/scanning procedure using||
2191|196|P|iodinated contrast, tell your doctor or dentist about all the||
2191|197|P|products you use (including prescription drugs, nonprescription||
2191|198|P|drugs, and herbal products). You may need to stop this medication||
2191|199|P|for a short time for the surgery/procedure. Ask your doctor or||
2191|200|P|dentist for instructions before your surgery/procedure.||
2191|201|P|   Older adults may be at greater risk for side effects such as||
2191|202|P|low blood sugar, dehydration, lactic acidosis, kidney problems,||
2191|203|P|and low blood pressure.||
2191|204|P|   During pregnancy, this medication should be used only when||
2191|205|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2191|206|P|benefits with your doctor.||
2191|207|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
2191|208|P|your doctor for managing your blood sugar while pregnant. Your||
2191|209|P|doctor may change your diabetes treatment during your pregnancy||
2191|210|P|(such as diet and medications including insulin).||
2191|211|P|   Metformin can cause changes in the menstrual cycle (promote||
2191|212|P|ovulation) and increase the risk of becoming pregnant. Consult||
2191|213|P|your doctor or pharmacist about the use of reliable birth control||
2191|214|P|while using this medication.||
2191|215|P|   Metformin passes into breast milk in small amounts. It is||
2191|216|P|unknown if empagliflozin or linagliptin passes into breast milk.||
2191|217|P|Consult your doctor before breastfeeding.||
2191|218|B|||
2191|219|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2191|220|I|medications work or increase your risk for serious side effects.||
2191|221|I|This document does not contain all possible drug interactions.||
2191|222|I|Keep a list of all the products you use (including||
2191|223|I|prescription/nonprescription drugs and herbal products) and share||
2191|224|I|it with your doctor and pharmacist. Do not start, stop, or change||
2191|225|I|the dosage of any medicines without your doctor's approval.||
2191|226|I|   Other medications can affect the removal of linagliptin from||
2191|227|I|your body, which may affect how linagliptin works. One example is||
2191|228|I|rifampin, among others.||
2191|229|I|   Beta blocker medications (such as metoprolol, propranolol,||
2191|230|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
2191|231|I|heartbeat you would usually feel when your blood sugar falls too||
2191|232|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
2191|233|I|dizziness, hunger, or sweating, are not affected by these drugs.||
2191|234|I|   Many drugs can affect your blood sugar, making it harder to||
2191|235|I|control. Before you start, stop, or change any medication, talk||
2191|236|I|with your doctor or pharmacist about how the medication may||
2191|237|I|affect your blood sugar. Check your blood sugar regularly as||
2191|238|I|directed and share the results with your doctor. Tell your doctor||
2191|239|I|right away if you have symptoms of high or low blood sugar. (See||
2191|240|I|also Side Effects section.) Your doctor may need to adjust your||
2191|241|I|diabetes medication, exercise program, or diet.||
2191|242|I|   Your urine will test positive for glucose. Make sure lab||
2191|243|I|personnel and all your doctors know you use this drug.||
2191|244|B|||
2191|245|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2191|246|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2191|247|O|poison control center right away. US residents can call||
2191|248|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2191|249|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
2191|250|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
2191|251|O|rapid breathing, slow/irregular heartbeat.||
2191|252|B|||
2191|253|N|NOTES:  Do not share this medication with others.||
2191|254|N|   Attend a diabetes education program to learn more about how to||
2191|255|N|manage your diabetes with medications, diet, exercise, and||
2191|256|N|regular medical exams.||
2191|257|N|   Learn the symptoms of high and low blood sugar and how to||
2191|258|N|treat low blood sugar. Check your blood sugar regularly as||
2191|259|N|directed.||
2191|260|N|   Lab and/or medical tests (such as kidney/liver function, blood||
2191|261|N|sugar, hemoglobin A1c, complete blood counts, cholesterol,||
2191|262|N|vitamin B12, ketones) should be done before you start taking this||
2191|263|N|medication and while you are taking it. Keep all medical and lab||
2191|264|N|appointments. Consult your doctor for more details.||
2191|265|B|||
2191|266|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2191|267|D|remember. If it is near the time of the next dose, skip the||
2191|268|D|missed dose. Take your next dose at the regular time. Do not||
2191|269|D|double the dose to catch up.||
2191|270|B|||
2191|271|R|STORAGE:  Store at room temperature away from light and moisture.||
2191|272|R|Do not store in the bathroom. Keep all medications away from||
2191|273|R|children and pets.||
2191|274|R|   Do not flush medications down the toilet or pour them into a||
2191|275|R|drain unless instructed to do so. Properly discard this product||
2191|276|R|when it is expired or no longer needed. Consult your pharmacist||
2191|277|R|or local waste disposal company.||
2191|278|B|||
2191|279|M|MEDICAL ALERT:  Your condition can cause complications in a||
2191|280|M|medical emergency. For information about enrolling in MedicAlert,||
2191|281|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2191|282|B|||
2191|283|A|Information last revised May 2025.||
2191|284|A|Copyright(c) 2025 First Databank, Inc.||
2191|285|B|||
2192|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2192|002|Z|does NOT have all possible information about this product. This||
2192|003|Z|information does not assure that this product is safe, effective,||
2192|004|Z|or appropriate for you. This information is not individual||
2192|005|Z|medical advice and does not substitute for the advice of your||
2192|006|Z|health care professional. Always ask your health care||
2192|007|Z|professional for complete information about this product and your||
2192|008|Z|specific health needs.||
2192|009|B|||
2192|010|T|EPTINEZUMAB - INJECTION||
2192|011|F|(EP-ti-NEZ-ue-mab)||
2192|012|B|||
2192|013|C|COMMON BRAND NAME(S): Vyepti||
2192|014|B|||
2192|015|U|USES:  This medication is used to help prevent migraine. This||
2192|016|U|medication may work by changing the amounts of certain natural||
2192|017|U|substances in the brain. Eptinezumab belongs to a class of drugs||
2192|018|U|known as monoclonal antibodies. Preventing frequent migraine||
2192|019|U|attacks can help improve your ability to concentrate and do your||
2192|020|U|usual tasks.||
2192|021|B|||
2192|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2192|023|H|from your pharmacist before you start using eptinezumab and each||
2192|024|H|time you get a refill. If you have any questions, ask your doctor||
2192|025|H|or pharmacist.||
2192|026|H|   This medication is given by injection into a vein by a health||
2192|027|H|care professional as directed by your doctor, usually every 3||
2192|028|H|months. The injection is usually given over about 30 minutes. The||
2192|029|H|dosage is based on your medical condition and response to||
2192|030|H|treatment.||
2192|031|H|   Use this medication regularly to get the most benefit from it.||
2192|032|H|To help you remember, mark your calendar with a reminder.||
2192|033|H|   Tell your doctor if your migraines happen more often or get||
2192|034|H|worse.||
2192|035|B|||
2192|036|S|SIDE EFFECTS:  Itching or flushing on the day of the injection||
2192|037|S|may occur. If either of these effects lasts or gets worse, tell||
2192|038|S|your doctor or pharmacist promptly.||
2192|039|S|   Remember that this medication has been prescribed because your||
2192|040|S|doctor has judged that the benefit to you is greater than the||
2192|041|S|risk of side effects. Many people using this medication do not||
2192|042|S|have serious side effects.||
2192|043|S|   This medication may raise your blood pressure. Check your||
2192|044|S|blood pressure regularly and tell your doctor if the results are||
2192|045|S|high. Your doctor may control your blood pressure with||
2192|046|S|medication.||
2192|047|S|   Tell your doctor right away if you have any serious side||
2192|048|S|effects, including: blue fingers/toes, cold hands/feet.||
2192|049|S|   A very serious allergic reaction to this drug is rare.||
2192|050|S|However, get medical help right away if you notice any symptoms||
2192|051|S|of a serious allergic reaction, including: rash, itching/swelling||
2192|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2192|053|S|breathing.||
2192|054|S|   This is not a complete list of possible side effects. If you||
2192|055|S|notice other effects not listed above, contact your doctor or||
2192|056|S|pharmacist.||
2192|057|S|   In the US -||
2192|058|S|   Call your doctor for medical advice about side effects. You||
2192|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2192|060|S|www.fda.gov/medwatch.||
2192|061|S|   In Canada - Call your doctor for medical advice about side||
2192|062|S|effects. You may report side effects to Health Canada at||
2192|063|S|1-866-234-2345.||
2192|064|B|||
2192|065|P|PRECAUTIONS:  Before using eptinezumab, tell your doctor or||
2192|066|P|pharmacist if you are allergic to it; or if you have any other||
2192|067|P|allergies. This product may contain inactive ingredients, which||
2192|068|P|can cause allergic reactions or other problems. Talk to your||
2192|069|P|pharmacist for more details.||
2192|070|P|   Before using this medication, tell your doctor or pharmacist||
2192|071|P|your medical history, especially of: blood circulation problems||
2192|072|P|(such as Raynaud's disease), high blood pressure.||
2192|073|P|   Before having surgery, tell your doctor or dentist about all||
2192|074|P|the products you use (including prescription drugs,||
2192|075|P|nonprescription drugs, and herbal products).||
2192|076|P|   During pregnancy, this medication should be used only when||
2192|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
2192|078|P|   It is unknown if this medication passes into breast milk.||
2192|079|P|Consult your doctor before breastfeeding.||
2192|080|B|||
2192|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2192|082|I|medications work or increase your risk for serious side effects.||
2192|083|I|This document does not contain all possible drug interactions.||
2192|084|I|Keep a list of all the products you use (including||
2192|085|I|prescription/nonprescription drugs and herbal products) and share||
2192|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
2192|087|I|the dosage of any medicines without your doctor's approval.||
2192|088|B|||
2192|089|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2192|090|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2192|091|O|poison control center right away. US residents can call||
2192|092|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2192|093|B|||
2192|094|N|NOTES:  Certain foods, beverages, or food additives (such as red||
2192|095|N|wine, cheese, chocolate, monosodium glutamate) as well as||
2192|096|N|lifestyle patterns such as irregular eating/sleeping habits or||
2192|097|N|stress may bring on a migraine headache. Avoiding these||
2192|098|N|"triggers" may help lessen migraine attacks. Consult your doctor||
2192|099|N|for more details.||
2192|100|N|   Lab and/or medical tests (such as blood pressure) may be done||
2192|101|N|while you are using this medication. Keep all medical and lab||
2192|102|N|appointments. Consult your doctor for more details.||
2192|103|B|||
2192|104|D|MISSED DOSE:  It is important to get each dose of this medication||
2192|105|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2192|106|D|right away for a new dosing schedule.||
2192|107|B|||
2192|108|R|STORAGE:  Not applicable. This medication is given in a hospital||
2192|109|R|or clinic or doctor's office and will not be stored at home.||
2192|110|B|||
2192|111|A|Information last revised March 2025.||
2192|112|A|Copyright(c) 2025 First Databank, Inc.||
2192|113|B|||
2193|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2193|002|Z|does NOT have all possible information about this product. This||
2193|003|Z|information does not assure that this product is safe, effective,||
2193|004|Z|or appropriate for you. This information is not individual||
2193|005|Z|medical advice and does not substitute for the advice of your||
2193|006|Z|health care professional. Always ask your health care||
2193|007|Z|professional for complete information about this product and your||
2193|008|Z|specific health needs.||
2193|009|B|||
2193|010|T|REMDESIVIR - INJECTION||
2193|011|F|(rem-DE-si-vir)||
2193|012|B|||
2193|013|C|COMMON BRAND NAME(S): Veklury||
2193|014|B|||
2193|015|U|USES:  Remdesivir is used to treat coronavirus disease, also||
2193|016|U|known as COVID-19, for certain patients who are in the hospital.||
2193|017|U|Remdesivir is an antiviral drug.||
2193|018|U|   Remdesivir may also be used to treat patients with COVID-19||
2193|019|U|who are not in the hospital, but have a high risk for COVID-19||
2193|020|U|complications due to older age, obesity, or ongoing medical||
2193|021|U|conditions (such as lung, kidney, or heart disease, diabetes).||
2193|022|B|||
2193|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2193|024|H|from your pharmacist before you start using remdesivir and each||
2193|025|H|time you receive an injection. If you have any questions, ask||
2193|026|H|your doctor or pharmacist.||
2193|027|H|   This medication is given by injection into a vein by a health||
2193|028|H|care professional. It is given as directed by your doctor,||
2193|029|H|usually once daily. It is given for 5 to 10 days for patients who||
2193|030|H|are in the hospital and for 3 days for patients who are not in||
2193|031|H|the hospital. It is infused over a period ranging from 30 minutes||
2193|032|H|to 2 hours. A health care professional will observe you during||
2193|033|H|your infusion and for at least another hour after your treatment||
2193|034|H|in case you have serious side effects.||
2193|035|H|   The length of treatment depends on your medical condition and||
2193|036|H|response to treatment. Children's dosage is based on weight.||
2193|037|H|   Infusion reactions may happen during or after the infusion of||
2193|038|H|this drug. Tell your doctor right away if you have any symptoms||
2193|039|H|of infusion reactions such as dizziness, slow/fast heartbeat,||
2193|040|H|fever, shortness of breath, nausea, sweating, or shivering. Your||
2193|041|H|doctor may slow down your infusion.||
2193|042|H|   Tell your doctor if your condition lasts or gets worse.||
2193|043|B|||
2193|044|S|SIDE EFFECTS:  See also How to Use section.||
2193|045|S|   Remember that this medication has been prescribed because your||
2193|046|S|doctor has judged that the benefit to you is greater than the||
2193|047|S|risk of side effects. Many people using this medication do not||
2193|048|S|have serious side effects.||
2193|049|S|   A very serious allergic reaction to this drug is rare.||
2193|050|S|However, get medical help right away if you notice any symptoms||
2193|051|S|of a serious allergic reaction, including: rash, itching/swelling||
2193|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2193|053|S|breathing.||
2193|054|S|   This is not a complete list of possible side effects. If you||
2193|055|S|notice other effects not listed above, contact your doctor or||
2193|056|S|pharmacist.||
2193|057|S|   In the US -||
2193|058|S|   Call your doctor for medical advice about side effects. You||
2193|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2193|060|S|www.fda.gov/medwatch.||
2193|061|S|   In Canada - Call your doctor for medical advice about side||
2193|062|S|effects. You may report side effects to Health Canada at||
2193|063|S|1-866-234-2345.||
2193|064|B|||
2193|065|P|PRECAUTIONS:  Before using remdesivir, tell your doctor or||
2193|066|P|pharmacist if you are allergic to it; or if you have any other||
2193|067|P|allergies. This product may contain inactive ingredients, which||
2193|068|P|can cause allergic reactions or other problems. Talk to your||
2193|069|P|pharmacist for more details.||
2193|070|P|   Before using this medication, tell your doctor or pharmacist||
2193|071|P|your medical history, especially of: liver disease.||
2193|072|P|   Before having surgery, tell your doctor or dentist about all||
2193|073|P|the products you use (including prescription drugs,||
2193|074|P|nonprescription drugs, and herbal products).||
2193|075|P|   During pregnancy, this medication should be used only when||
2193|076|P|clearly needed. Discuss the risks and benefits with your doctor.||
2193|077|P|   This medication passes into breast milk. Consult your doctor||
2193|078|P|before breastfeeding.||
2193|079|B|||
2193|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2193|081|I|medications work or increase your risk for serious side effects.||
2193|082|I|This document does not contain all possible drug interactions.||
2193|083|I|Keep a list of all the products you use (including||
2193|084|I|prescription/nonprescription drugs and herbal products) and share||
2193|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
2193|086|I|the dosage of any medicines without your doctor's approval.||
2193|087|I|   Some products that may interact with this drug are:||
2193|088|I|chloroquine, hydroxychloroquine.||
2193|089|B|||
2193|090|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2193|091|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2193|092|O|poison control center right away. US residents can call||
2193|093|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2193|094|B|||
2193|095|N|NOTES:  Lab and/or medical tests (such as liver function, blood||
2193|096|N|mineral levels, complete blood count, a blood clotting test known||
2193|097|N|as prothrombin time) should be done before and during remdesivir||
2193|098|N|treatment. Keep all medical and lab appointments. Consult your||
2193|099|N|doctor for more details.||
2193|100|B|||
2193|101|D|MISSED DOSE:  It is important to get each dose of this medication||
2193|102|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2193|103|D|right away for a new dosing schedule.||
2193|104|B|||
2193|105|R|STORAGE:  Not applicable. This medication is given in a hospital||
2193|106|R|and will not be stored at home.||
2193|107|B|||
2193|108|A|Information last revised November 2024.||
2193|109|A|Copyright(c) 2025 First Databank, Inc.||
2193|110|B|||
2194|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2194|002|Z|does NOT have all possible information about this product. This||
2194|003|Z|information does not assure that this product is safe, effective,||
2194|004|Z|or appropriate for you. This information is not individual||
2194|005|Z|medical advice and does not substitute for the advice of your||
2194|006|Z|health care professional. Always ask your health care||
2194|007|Z|professional for complete information about this product and your||
2194|008|Z|specific health needs.||
2194|009|B|||
2194|010|T|METHADONE - ORAL||
2194|011|F|(METH-uh-doan)||
2194|012|B|||
2194|013|C|COMMON BRAND NAME(S): Dolophine, Methadose||
2194|014|B|||
2194|015|W|WARNING:  Methadone has a risk for abuse and addiction, which can||
2194|016|W|lead to overdose and death. Methadone may also cause severe,||
2194|017|W|possibly fatal, breathing problems and heartbeat problems. To||
2194|018|W|lower your risk, your doctor should have you take the smallest||
2194|019|W|dose of methadone that works, and take it for the shortest||
2194|020|W|possible time. Do not increase your dose or take this medication||
2194|021|W|more often than directed. See also How to Use section for more||
2194|022|W|information about addiction.||
2194|023|W|   Ask your doctor or pharmacist if you should have medication||
2194|024|W|available to treat opioid overdose (such as naloxone, nalmefene).||
2194|025|W|Teach your family or household members about the signs of an||
2194|026|W|opioid overdose and how to treat it.||
2194|027|W|   The risk for severe breathing problems or heartbeat problems||
2194|028|W|is higher when you start this medication, when you are switching||
2194|029|W|from another opioid to methadone, after a dose increase, or if||
2194|030|W|you take the wrong dose/strength. Breathing problems from||
2194|031|W|methadone may not happen right away after taking a dose. Most||
2194|032|W|heartbeat problems have happened in people using large doses of||
2194|033|W|methadone for pain relief, but this problem can also occur in||
2194|034|W|people taking smaller doses to treat opioid addiction. Taking||
2194|035|W|this medication with alcohol or other drugs that can cause||
2194|036|W|drowsiness or breathing problems may cause very serious side||
2194|037|W|effects, including death. Also, other medications can affect the||
2194|038|W|removal of methadone from your body, which may affect how||
2194|039|W|methadone works. Be sure you know how to take methadone and what||
2194|040|W|other drugs you should avoid taking with it. See also Drug||
2194|041|W|Interactions section. Get medical help right away if any of these||
2194|042|W|very serious side effects occur: slow/shallow breathing, unusual||
2194|043|W|lightheadedness, severe drowsiness/dizziness, difficulty waking||
2194|044|W|up, fast/irregular heartbeat, fainting.||
2194|045|W|   Keep this medicine in a safe place to prevent theft, misuse,||
2194|046|W|or abuse. If someone accidentally swallows this drug, get medical||
2194|047|W|help right away.||
2194|048|W|   Before using this medication, women of childbearing age should||
2194|049|W|talk with their doctor(s) about the risks and benefits. Pregnancy||
2194|050|W|may affect the amount of this drug in your body, so tell your||
2194|051|W|doctor if you are pregnant or if you plan to become pregnant.||
2194|052|W|During pregnancy, this medication should be used only when||
2194|053|W|clearly needed. It may slightly increase the risk of birth||
2194|054|W|defects if used during the first two months of pregnancy. Also,||
2194|055|W|using it for a long time or in high doses near the expected||
2194|056|W|delivery date may harm the unborn baby. To lessen the risk, take||
2194|057|W|the smallest effective dose for the shortest possible time.||
2194|058|W|Babies born to mothers who use this drug for a long time may||
2194|059|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
2194|060|W|doctor right away if you notice any symptoms in your newborn baby||
2194|061|W|such as crying that doesn't stop, slow/shallow breathing,||
2194|062|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
2194|063|W|difficulty gaining weight.||
2194|064|B|||
2194|065|U|USES:  This medication is used to treat severe ongoing pain (such||
2194|066|U|as due to cancer). Methadone belongs to a class of drugs known as||
2194|067|U|opioid analgesics. It works in the brain to change how your body||
2194|068|U|feels and responds to pain.||
2194|069|U|   Do not use this medication to relieve pain that is mild or||
2194|070|U|that will go away in a few days (such as pain from surgery). This||
2194|071|U|medication is not for occasional ("as needed") use.||
2194|072|U|   This medication is also used to treat opioid use disorder as||
2194|073|U|part of an approved treatment program. It helps prevent||
2194|074|U|withdrawal symptoms caused by stopping other opioids.||
2194|075|B|||
2194|076|H|HOW TO USE:  See also Warning section.||
2194|077|H|   Read the Medication Guide and Patient Information Leaflet if||
2194|078|H|available from your pharmacist before you start using methadone||
2194|079|H|and each time you get a refill. If you have any questions, ask||
2194|080|H|your doctor or pharmacist.||
2194|081|H|   Take this medication by mouth on a regular schedule as||
2194|082|H|directed by your doctor and not as needed for sudden||
2194|083|H|(breakthrough) pain. You may take this drug with or without food.||
2194|084|H|If you have nausea, it may help to take this drug with food. Ask||
2194|085|H|your doctor or pharmacist about other ways to decrease nausea||
2194|086|H|(such as lying down for 1 to 2 hours with as little head movement||
2194|087|H|as possible).||
2194|088|H|   If you are using the liquid form of this medication, measure||
2194|089|H|the dose carefully using a special measuring device/spoon. Do not||
2194|090|H|use a household spoon because you may not get the correct dose.||
2194|091|H|   The dosage is based on your medical condition and response to||
2194|092|H|treatment.||
2194|093|H|   Suddenly stopping this medication may cause withdrawal,||
2194|094|H|especially if you have used it for a long time or in high doses.||
2194|095|H|To prevent withdrawal, your doctor may lower your dose slowly.||
2194|096|H|Tell your doctor or pharmacist right away if you have any||
2194|097|H|withdrawal symptoms such as restlessness, mental/mood changes||
2194|098|H|(including anxiety, trouble sleeping, thoughts of suicide),||
2194|099|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
2194|100|H|aches, or sudden changes in behavior.||
2194|101|H|   When this medication is used for a long time, it may not work||
2194|102|H|as well. Talk with your doctor if this medication stops working||
2194|103|H|well.||
2194|104|H|   Though it helps many people, this medication may sometimes||
2194|105|H|cause addiction. This risk may be higher if you have a||
2194|106|H|mental/mood disorder or a substance use disorder (such as overuse||
2194|107|H|of or addiction to drugs/alcohol). Take this medication exactly||
2194|108|H|as prescribed to lower the risk of addiction. Stopping methadone||
2194|109|H|maintenance treatment has a high risk of return to opioid abuse.||
2194|110|H|Ask your doctor or pharmacist for more details.||
2194|111|H|   Tell your doctor if your condition does not get better or if||
2194|112|H|it gets worse, or if you have any new pain.||
2194|113|B|||
2194|114|S|SIDE EFFECTS:  See also Warning section.||
2194|115|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
2194|116|S|dry mouth, drowsiness, or sweating may occur. Some of these side||
2194|117|S|effects may decrease after you have been using this medication||
2194|118|S|for a while. If any of these effects last or get worse, tell your||
2194|119|S|doctor or pharmacist promptly.||
2194|120|S|   To prevent constipation, eat dietary fiber, drink enough||
2194|121|S|water, and exercise. You may also need to take a laxative. Ask||
2194|122|S|your pharmacist which type of laxative is right for you.||
2194|123|S|   To reduce the risk of dizziness and lightheadedness, get up||
2194|124|S|slowly when rising from a sitting or lying position.||
2194|125|S|   Remember that this medication has been prescribed because your||
2194|126|S|doctor has judged that the benefit to you is greater than the||
2194|127|S|risk of side effects. Many people using this medication do not||
2194|128|S|have serious side effects.||
2194|129|S|   Tell your doctor right away if you have any serious side||
2194|130|S|effects, including: interrupted breathing during sleep (sleep||
2194|131|S|apnea), mental/mood changes (such as agitation, confusion,||
2194|132|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
2194|133|S|signs of your adrenal glands not working well (such as loss of||
2194|134|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
2194|135|S|   Get medical help right away if you have any very serious side||
2194|136|S|effects, including: seizure, severe drowsiness/difficulty waking||
2194|137|S|up.||
2194|138|S|   A very serious allergic reaction to this drug is rare.||
2194|139|S|However, get medical help right away if you notice any symptoms||
2194|140|S|of a serious allergic reaction, including: rash, itching/swelling||
2194|141|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2194|142|S|breathing.||
2194|143|S|   This is not a complete list of possible side effects. If you||
2194|144|S|notice other effects not listed above, contact your doctor or||
2194|145|S|pharmacist.||
2194|146|S|   In the US -||
2194|147|S|   Call your doctor for medical advice about side effects. You||
2194|148|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2194|149|S|www.fda.gov/medwatch.||
2194|150|S|   In Canada - Call your doctor for medical advice about side||
2194|151|S|effects. You may report side effects to Health Canada at||
2194|152|S|1-866-234-2345.||
2194|153|B|||
2194|154|P|PRECAUTIONS:  Before taking methadone, tell your doctor or||
2194|155|P|pharmacist if you are allergic to it; or if you have any other||
2194|156|P|allergies. This product may contain inactive ingredients, which||
2194|157|P|can cause allergic reactions or other problems. Talk to your||
2194|158|P|pharmacist for more details.||
2194|159|P|   Before using this medication, tell your doctor or pharmacist||
2194|160|P|your medical history, especially of: brain disorders (such as||
2194|161|P|head injury, tumor, seizures), breathing problems (such as||
2194|162|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
2194|163|P|kidney disease, liver disease, mental/mood disorders (such as||
2194|164|P|confusion, depression, thoughts of suicide), personal or family||
2194|165|P|history of a substance use disorder (such as overuse of or||
2194|166|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
2194|167|P|blockage, constipation, diarrhea due to infection, paralytic||
2194|168|P|ileus), difficulty urinating (such as due to enlarged prostate),||
2194|169|P|disease of the pancreas (pancreatitis), gallbladder disease.||
2194|170|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2194|171|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2194|172|P|machinery, or do anything that needs alertness until you can do||
2194|173|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2194|174|P|are using marijuana (cannabis).||
2194|175|P|   Methadone may cause a condition that affects the heart rhythm||
2194|176|P|(QT prolongation). QT prolongation can rarely cause serious||
2194|177|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2194|178|P|as severe dizziness, fainting) that need medical attention right||
2194|179|P|away.||
2194|180|P|   The risk of QT prolongation may be increased if you have||
2194|181|P|certain medical conditions or are taking other drugs that may||
2194|182|P|cause QT prolongation. Before using methadone, tell your doctor||
2194|183|P|or pharmacist of all the drugs you take and if you have any of||
2194|184|P|the following conditions: certain heart problems (heart failure,||
2194|185|P|slow heartbeat, QT prolongation in the EKG), family history of||
2194|186|P|certain heart problems (QT prolongation in the EKG, sudden||
2194|187|P|cardiac death).||
2194|188|P|   Low levels of potassium or magnesium in the blood may also||
2194|189|P|increase your risk of QT prolongation. This risk may increase if||
2194|190|P|you use certain drugs (such as diuretics/"water pills") or if you||
2194|191|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2194|192|P|Talk to your doctor about using methadone safely.||
2194|193|P|   Liquid products may contain sugar and/or alcohol. Caution is||
2194|194|P|advised if you have diabetes, alcohol dependence, liver disease,||
2194|195|P|or any other condition that requires you to limit/avoid these||
2194|196|P|substances in your diet.||
2194|197|P|   Before having surgery, tell your doctor or dentist about all||
2194|198|P|the products you use (including prescription drugs,||
2194|199|P|nonprescription drugs, and herbal products).||
2194|200|P|   Older adults may be more sensitive to the effects of this||
2194|201|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
2194|202|P|breathing, and QT prolongation (see above).||
2194|203|P|   During pregnancy, this medication should be used only when||
2194|204|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2194|205|P|benefits with your doctor. (See also Warning section.)||
2194|206|P|   This drug passes into breast milk and may have undesirable||
2194|207|P|effects on a nursing infant. Tell the doctor right away if your||
2194|208|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
2194|209|P|breathing. Consult your doctor before breastfeeding or if you||
2194|210|P|plan to stop breastfeeding.||
2194|211|B|||
2194|212|I|DRUG INTERACTIONS:  See also Warning section.||
2194|213|I|   Drug interactions may change how your medications work or||
2194|214|I|increase your risk for serious side effects. This document does||
2194|215|I|not contain all possible drug interactions. Keep a list of all||
2194|216|I|the products you use (including prescription/nonprescription||
2194|217|I|drugs and herbal products) and share it with your doctor and||
2194|218|I|pharmacist. Do not start, stop, or change the dosage of any||
2194|219|I|medicines without your doctor's approval.||
2194|220|I|   Some products that may interact with this drug include:||
2194|221|I|certain pain medications (mixed opioid agonist-antagonists such||
2194|222|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
2194|223|I|samidorphan.||
2194|224|I|   Taking MAO inhibitors with this medication may cause a serious||
2194|225|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
2194|226|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2194|227|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2194|228|I|selegiline, tranylcypromine) during treatment with this||
2194|229|I|medication. Most MAO inhibitors should also not be taken for two||
2194|230|I|weeks before and after treatment with this medication. Ask your||
2194|231|I|doctor when to start or stop taking this medication.||
2194|232|I|   Other medications can affect the removal of methadone from||
2194|233|I|your body, which may affect how methadone works. Examples include||
2194|234|I|St. John's wort, azole antifungals (such as itraconazole),||
2194|235|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
2194|236|I|rifampin), drugs used to treat seizures (such as carbamazepine),||
2194|237|I|among others.||
2194|238|I|   The risk of serious side effects (such as slow/shallow||
2194|239|I|breathing, severe drowsiness/dizziness) may be increased if this||
2194|240|I|medication is taken with other products that may also cause||
2194|241|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2194|242|I|if you are taking other products such as other opioid pain or||
2194|243|I|cough relievers (such as codeine, hydrocodone), alcohol,||
2194|244|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
2194|245|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2194|246|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2194|247|I|cetirizine, diphenhydramine).||
2194|248|I|   Check the labels on all your medicines (such as allergy or||
2194|249|I|cough-and-cold products) because they may contain ingredients||
2194|250|I|that cause drowsiness. Ask your pharmacist about using those||
2194|251|I|products safely.||
2194|252|I|   This medication may interfere with certain lab tests (such as||
2194|253|I|amylase/lipase levels), possibly causing false test results. Make||
2194|254|I|sure lab personnel and all your doctors know you use this drug.||
2194|255|B|||
2194|256|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2194|257|O|as passing out or trouble breathing, give them naloxone or||
2194|258|O|nalmefene if available, then call 911. If the person is awake and||
2194|259|O|has no symptoms, call a poison control center right away. US||
2194|260|O|residents can call 1-800-222-1222. Canada residents can call||
2194|261|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
2194|262|O|breathing, slow heartbeat, coma.||
2194|263|B|||
2194|264|N|NOTES:  Do not share this medication with others. Sharing it is||
2194|265|N|against the law.||
2194|266|N|   This medication has been prescribed for your current condition||
2194|267|N|only. Do not use it later for another condition unless told to do||
2194|268|N|so by your doctor. A different medication may be necessary in||
2194|269|N|those cases.||
2194|270|B|||
2194|271|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2194|272|D|remember. If it is near the time of the next dose, skip the||
2194|273|D|missed dose. Take your next dose at the regular time. Do not||
2194|274|D|double the dose to catch up.||
2194|275|B|||
2194|276|R|STORAGE:  Store at room temperature away from light and moisture.||
2194|277|R|Do not store in the bathroom. Keep all medications away from||
2194|278|R|children and pets. See also Warning section.||
2194|279|R|   Do not flush medications down the toilet or pour them into a||
2194|280|R|drain unless instructed to do so. Properly discard this product||
2194|281|R|when it is expired or no longer needed. For more details, read||
2194|282|R|the Medication Guide, or consult your pharmacist or local waste||
2194|283|R|disposal company.||
2194|284|B|||
2194|285|A|Information last revised August 2025.||
2194|286|A|Copyright(c) 2025 First Databank, Inc.||
2194|287|B|||
2195|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2195|002|Z|does NOT have all possible information about this product. This||
2195|003|Z|information does not assure that this product is safe, effective,||
2195|004|Z|or appropriate for you. This information is not individual||
2195|005|Z|medical advice and does not substitute for the advice of your||
2195|006|Z|health care professional. Always ask your health care||
2195|007|Z|professional for complete information about this product and your||
2195|008|Z|specific health needs.||
2195|009|B|||
2195|010|T|POTASSIUM IODIDE - ORAL||
2195|011|F|(poh-TASS-ee-um EYE-oh-dyed)||
2195|012|B|||
2195|013|C|COMMON BRAND NAME(S): SSKI||
2195|014|B|||
2195|015|U|USES:  Potassium iodide is used to loosen and break up mucus in||
2195|016|U|the airways. This helps you cough up the mucus so you can breathe||
2195|017|U|more easily if you have long-term lung problems (such as asthma,||
2195|018|U|chronic bronchitis, emphysema). This medication is known as an||
2195|019|U|expectorant.||
2195|020|U|   Potassium iodide is also used along with antithyroid medicines||
2195|021|U|to prepare the thyroid gland for surgical removal, to treat||
2195|022|U|certain overactive thyroid conditions (hyperthyroidism), and to||
2195|023|U|protect the thyroid in a radiation exposure emergency. It works||
2195|024|U|by shrinking the size of the thyroid gland and decreasing the||
2195|025|U|amount of thyroid hormones produced.||
2195|026|U|   In a radiation emergency, potassium iodide blocks only the||
2195|027|U|thyroid from absorbing radioactive iodine, protecting it from||
2195|028|U|damage and reducing the risk of thyroid cancer. Use this||
2195|029|U|medication along with other emergency measures that will be||
2195|030|U|recommended to you by public health and safety officials (such as||
2195|031|U|finding safe shelter, evacuation, controlling food supply).||
2195|032|B|||
2195|033|V|OTHER USES:  This section contains uses of this drug that are not||
2195|034|V|listed in the approved professional labeling for the drug but||
2195|035|V|that may be prescribed by your health care professional. Use this||
2195|036|V|drug for a condition that is listed in this section only if it||
2195|037|V|has been so prescribed by your health care professional.||
2195|038|V|   This drug may also be used for a certain type of fungal skin||
2195|039|V|infection (sporotrichosis).||
2195|040|B|||
2195|041|H|HOW TO USE:  Take this medication by mouth with a full glass of||
2195|042|H|water (8 ounces or 240 milliliters) as directed by your doctor or||
2195|043|H|public health and safety officials. To avoid stomach upset, take||
2195|044|H|after meals or with food. Drink plenty of liquids with this||
2195|045|H|medication unless otherwise directed. If you are taking the||
2195|046|H|tablets, do not lie down for at least 10 minutes after taking||
2195|047|H|this medication. If you are using the drops or liquid medication,||
2195|048|H|use the dropper that comes with the bottle or a medication||
2195|049|H|spoon/device to measure the correct dose. Liquid forms of this||
2195|050|H|product may be mixed in water, milk, formula, or juice before||
2195|051|H|taking. Do not use this medication if the solution turns||
2195|052|H|brownish-yellow.||
2195|053|H|   The dosage is based on your medical condition and response to||
2195|054|H|treatment. Children's dosage is also based on age. Do not||
2195|055|H|increase your dose, take it more often, or take it for longer||
2195|056|H|than prescribed or recommended because of the increased risk of||
2195|057|H|side effects.||
2195|058|H|   In a radiation emergency, take this drug only when public||
2195|059|H|health and safety officials tell you to do so. Read the Patient||
2195|060|H|Information Leaflet that comes with the medication. Start||
2195|061|H|treatment as soon as possible for the best protection. Take this||
2195|062|H|medication usually once every 24 hours. The length of treatment||
2195|063|H|will be determined by public health and safety officials and||
2195|064|H|depends on several factors (such as whether you continue to be||
2195|065|H|exposed to the radiation, and whether you are pregnant,||
2195|066|H|breastfeeding, or have a newborn baby). See also Precautions.||
2195|067|H|   If so directed, use this medication regularly to get the most||
2195|068|H|benefit from it. To help you remember, take it at the same||
2195|069|H|time(s) each day.||
2195|070|H|   Tell your doctor if your condition lasts or gets worse.||
2195|071|B|||
2195|072|S|SIDE EFFECTS:  Nausea, vomiting, stomach ache, diarrhea, metallic||
2195|073|S|taste in the mouth, fever, headache, or acne may occur. If any of||
2195|074|S|these effects last or get worse, tell your doctor or pharmacist||
2195|075|S|promptly.||
2195|076|S|   If your doctor has directed you to use this medication,||
2195|077|S|remember that your doctor has judged that the benefit to you is||
2195|078|S|greater than the risk of side effects. Many people using this||
2195|079|S|medication do not have serious side effects.||
2195|080|S|   Tell your doctor right away if you have any serious side||
2195|081|S|effects, including: burning mouth/throat, sore teeth/gums,||
2195|082|S|swelling inside the mouth, increased saliva, eye||
2195|083|S|irritation/swollen eyelids, severe headache, swelling of the||
2195|084|S|front of the neck/throat (goiter), signs of decreased thyroid||
2195|085|S|gland function (such as weight gain, cold intolerance,||
2195|086|S|slow/irregular heartbeat, constipation, unusual tiredness),||
2195|087|S|confusion, numbness/tingling/pain/weakness of the hands/feet.||
2195|088|S|   Get medical help right away if you have any very serious side||
2195|089|S|effects, including: chest pain, black stools, vomit that looks||
2195|090|S|like coffee grounds, bloody diarrhea.||
2195|091|S|   A very serious allergic reaction to this drug is rare.||
2195|092|S|However, get medical help right away if you notice any symptoms||
2195|093|S|of a serious allergic reaction, including: rash, itching/swelling||
2195|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2195|095|S|breathing, fever with joint pain.||
2195|096|S|   This is not a complete list of possible side effects. If you||
2195|097|S|notice other effects not listed above, contact your doctor or||
2195|098|S|pharmacist.||
2195|099|S|   In the US -||
2195|100|S|   Call your doctor for medical advice about side effects. You||
2195|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2195|102|S|www.fda.gov/medwatch.||
2195|103|S|   In Canada - Call your doctor for medical advice about side||
2195|104|S|effects. You may report side effects to Health Canada at||
2195|105|S|1-866-234-2345.||
2195|106|B|||
2195|107|P|PRECAUTIONS:  Before taking potassium iodide, tell your doctor or||
2195|108|P|pharmacist if you are allergic to it; or to iodine; or if you||
2195|109|P|have any other allergies. This product may contain inactive||
2195|110|P|ingredients, which can cause allergic reactions or other||
2195|111|P|problems. Talk to your pharmacist for more details.||
2195|112|P|   Before using this medication, tell your doctor or pharmacist||
2195|113|P|your medical history, especially of: current attack/worsening of||
2195|114|P|bronchitis (if taking potassium iodide to thin mucus in the||
2195|115|P|lungs), a certain type of skin condition (dermatitis||
2195|116|P|herpetiformis), a certain type of blood vessel disease||
2195|117|P|(hypocomplementemic vasculitis), certain thyroid disorders (such||
2195|118|P|as multinodular goiter, Graves' disease, autoimmune thyroiditis,||
2195|119|P|nodular thyroid disease with heart disease), overactive thyroid||
2195|120|P|disease (unless you are specifically prescribed potassium iodide||
2195|121|P|to treat hyperthyroidism), tuberculosis, high potassium blood||
2195|122|P|level, kidney disease, Addison's disease, a certain muscle||
2195|123|P|disorder (myotonia congenita).||
2195|124|P|   Caution is advised when this drug is given to newborn babies||
2195|125|P|younger than 1 month old. Treatment for more than 1 day should be||
2195|126|P|avoided because repeated dosing increases the risk of blocking||
2195|127|P|thyroid function, possibly affecting the newborn's brain||
2195|128|P|development. If treatment is needed for longer than 1 day,||
2195|129|P|discuss the risks and benefits with the doctor. Treated babies||
2195|130|P|should be given thyroid function tests.||
2195|131|P|   During pregnancy, this medication should be used only when||
2195|132|P|clearly needed. Treatment for more than 1 day should be avoided||
2195|133|P|because repeated dosing increases the risk of blocking thyroid||
2195|134|P|function in the unborn baby, possibly causing harm. If treatment||
2195|135|P|is needed for longer than 1 day, discuss the risks and benefits||
2195|136|P|with your doctor.||
2195|137|P|   Caution is advised when this drug is used by women who are||
2195|138|P|breastfeeding. This drug passes into breast milk. Treatment for||
2195|139|P|more than 1 day should be avoided if you are breastfeeding||
2195|140|P|because repeated dosing increases the risk of blocking thyroid||
2195|141|P|function in the nursing infant. This effect may cause harm,||
2195|142|P|especially in newborns younger than 1 month old. If treatment is||
2195|143|P|needed for longer than 1 day, discuss with your doctor the risks||
2195|144|P|and benefits, as well as whether you should stop breastfeeding.||
2195|145|B|||
2195|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2195|147|I|medications work or increase your risk for serious side effects.||
2195|148|I|This document does not contain all possible drug interactions.||
2195|149|I|Keep a list of all the products you use (including||
2195|150|I|prescription/nonprescription drugs and herbal products) and share||
2195|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
2195|152|I|the dosage of any medicines without your doctor's approval.||
2195|153|I|   Some products that may interact with this drug are: ACE||
2195|154|I|inhibitors (such as captopril, lisinopril), angiotensin receptor||
2195|155|I|blockers (ARBs such as losartan, valsartan), certain "water||
2195|156|I|pills" (potassium-sparing diuretics such as amiloride,||
2195|157|I|spironolactone, triamterene), drospirenone, eplerenone, lithium,||
2195|158|I|potassium-containing drugs (including supplements such as||
2195|159|I|potassium chloride).||
2195|160|B|||
2195|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2195|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2195|163|O|poison control center right away. US residents can call||
2195|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2195|165|B|||
2195|166|N|NOTES:  Do not share this medication with others.||
2195|167|N|   Lab and/or medical tests (such as thyroid function) should be||
2195|168|N|done while you are taking this medication. Keep all medical and||
2195|169|N|lab appointments. Consult your doctor for more details.||
2195|170|B|||
2195|171|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2195|172|D|remember. If it is near the time of the next dose, skip the||
2195|173|D|missed dose. Take your next dose at the regular time. Do not||
2195|174|D|double the dose to catch up.||
2195|175|B|||
2195|176|R|STORAGE:  Store at room temperature away from light and moisture.||
2195|177|R|Do not freeze. If crystals form in the solution, dissolve them by||
2195|178|R|placing the closed bottle in a container of warm water, then||
2195|179|R|gently shake the bottle. Do not store in the bathroom. Keep all||
2195|180|R|medications away from children and pets.||
2195|181|R|   Do not flush medications down the toilet or pour them into a||
2195|182|R|drain unless instructed to do so. Properly discard this product||
2195|183|R|when it is expired or no longer needed. Consult your pharmacist||
2195|184|R|or local waste disposal company.||
2195|185|B|||
2195|186|A|Information last revised August 2024.||
2195|187|A|Copyright(c) 2025 First Databank, Inc.||
2195|188|B|||
2196|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2196|002|Z|does NOT have all possible information about this product. This||
2196|003|Z|information does not assure that this product is safe, effective,||
2196|004|Z|or appropriate for you. This information is not individual||
2196|005|Z|medical advice and does not substitute for the advice of your||
2196|006|Z|health care professional. Always ask your health care||
2196|007|Z|professional for complete information about this product and your||
2196|008|Z|specific health needs.||
2196|009|B|||
2196|010|T|HYDROCORTISONE/PRAMOXINE/CHLOROXYLENOL - TOPICAL||
2196|011|F|(HYE-droe-KOR-ti-sone/pram-OX-een/klor-oh-ZIGH-len-ol)||
2196|012|B|||
2196|013|C|COMMON BRAND NAME(S): Cortane-B||
2196|014|B|||
2196|015|U|USES:  This medication is used to treat infections of the||
2196|016|U|external ear (not including the ear canal). It reduces the||
2196|017|U|swelling, numbs the pain, and kills the germs common in these||
2196|018|U|types of infections.||
2196|019|B|||
2196|020|H|HOW TO USE:  Use this medication on the skin only. Apply to||
2196|021|H|affected areas as directed by your doctor. Avoid contact with the||
2196|022|H|eyes.||
2196|023|H|   This medication is not intended for use within the ear||
2196|024|H|(especially if the eardrum is punctured). If your infection also||
2196|025|H|includes your inner ear, then another medication is needed to||
2196|026|H|treat that condition. Consult your doctor for more instructions.||
2196|027|H|   Do not cover the area with plastic or waterproof bandages||
2196|028|H|unless directed to do so by your doctor.||
2196|029|H|   Use this medication regularly to get the most benefit from it.||
2196|030|H|Remember to use it at the same time(s) each day. Continue to use||
2196|031|H|this medication until the full prescribed amount is finished,||
2196|032|H|even if symptoms disappear after a few days. Stopping the||
2196|033|H|medication too early may result in a return of the infection.||
2196|034|B|||
2196|035|S|SIDE EFFECTS:  Burning, itching, irritation, dryness, rash, skin||
2196|036|S|thinning/streaks may occur. If any of these effects last or get||
2196|037|S|worse, tell your doctor or pharmacist promptly.||
2196|038|S|   Remember that this medication has been prescribed because your||
2196|039|S|doctor has judged that the benefit to you is greater than the||
2196|040|S|risk of side effects. Many people using this medication do not||
2196|041|S|have serious side effects.||
2196|042|S|   Tell your doctor right away if you have any serious side||
2196|043|S|effects, including: rounding out of the face, bulging "soft spot"||
2196|044|S|on infant's head.||
2196|045|S|   A very serious allergic reaction to this drug is rare.||
2196|046|S|However, get medical help right away if you notice any symptoms||
2196|047|S|of a serious allergic reaction, including: rash, itching/swelling||
2196|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2196|049|S|breathing.||
2196|050|S|   This is not a complete list of possible side effects. If you||
2196|051|S|notice other effects not listed above, contact your doctor or||
2196|052|S|pharmacist.||
2196|053|S|   In the US -||
2196|054|S|   Call your doctor for medical advice about side effects. You||
2196|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2196|056|S|www.fda.gov/medwatch.||
2196|057|S|   In Canada - Call your doctor for medical advice about side||
2196|058|S|effects. You may report side effects to Health Canada at||
2196|059|S|1-866-234-2345.||
2196|060|B|||
2196|061|P|PRECAUTIONS:  Before using||
2196|062|P|hydrocortisone/pramoxine/chloroxylenol, tell your doctor or||
2196|063|P|pharmacist if you are allergic to any of its ingredients; or if||
2196|064|P|you have any other allergies. This product may contain inactive||
2196|065|P|ingredients, which can cause allergic reactions or other||
2196|066|P|problems. Talk to your pharmacist for more details.||
2196|067|P|   Before using this medication, tell your doctor or pharmacist||
2196|068|P|your medical history, especially of: infections (such as||
2196|069|P|varicella or vaccinia), chronic or prolonged ear infection (such||
2196|070|P|as chronic otitis media).||
2196|071|P|   Children may be more sensitive to the effects of too much||
2196|072|P|corticosteroid medication. Consult your doctor or pharmacist for||
2196|073|P|more details.||
2196|074|P|   During pregnancy, this medication should be used only when||
2196|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
2196|076|P|   It is unknown if this drug passes into breast milk. Consult||
2196|077|P|your doctor before breastfeeding.||
2196|078|B|||
2196|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2196|080|I|medications work or increase your risk for serious side effects.||
2196|081|I|This document does not contain all possible drug interactions.||
2196|082|I|Keep a list of all the products you use (including||
2196|083|I|prescription/nonprescription drugs and herbal products) and share||
2196|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
2196|085|I|the dosage of any medicines without your doctor's approval.||
2196|086|B|||
2196|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2196|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2196|089|O|poison control center right away. US residents can call||
2196|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
2196|091|O|medicine may be harmful if swallowed.||
2196|092|B|||
2196|093|N|NOTES:  Do not share this medication with others.||
2196|094|N|   This medication has been prescribed for your current condition||
2196|095|N|only. Do not use it later for another infection unless your||
2196|096|N|doctor tells you to.||
2196|097|B|||
2196|098|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2196|099|D|If it is near the time of the next dose, skip the missed dose.||
2196|100|D|Use your next dose at the regular time. Do not double the dose to||
2196|101|D|catch up.||
2196|102|B|||
2196|103|R|STORAGE:  Store at room temperature. Keep all medications away||
2196|104|R|from children and pets.||
2196|105|R|   Do not flush medications down the toilet or pour them into a||
2196|106|R|drain unless instructed to do so. Properly discard this product||
2196|107|R|when it is expired or no longer needed. Consult your pharmacist||
2196|108|R|or local waste disposal company.||
2196|109|B|||
2196|110|A|Information last revised May 2024.||
2196|111|A|Copyright(c) 2025 First Databank, Inc.||
2196|112|B|||
2197|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2197|002|Z|does NOT have all possible information about this product. This||
2197|003|Z|information does not assure that this product is safe, effective,||
2197|004|Z|or appropriate for you. This information is not individual||
2197|005|Z|medical advice and does not substitute for the advice of your||
2197|006|Z|health care professional. Always ask your health care||
2197|007|Z|professional for complete information about this product and your||
2197|008|Z|specific health needs.||
2197|009|B|||
2197|010|T|CENOBAMATE - ORAL||
2197|011|F|(SEN-oh-BAM-ate)||
2197|012|B|||
2197|013|C|COMMON BRAND NAME(S): Xcopri||
2197|014|B|||
2197|015|U|USES:  This medication is used to treat a certain type of seizure||
2197|016|U|disorder (partial onset). It is not known exactly how it works,||
2197|017|U|but it may affect the action of some nerves that cause seizures.||
2197|018|B|||
2197|019|H|HOW TO USE:  Read the Medication Guide provided by your||
2197|020|H|pharmacist before you start taking cenobamate and each time you||
2197|021|H|get a refill. If you have any questions, ask your doctor or||
2197|022|H|pharmacist.||
2197|023|H|   Take this medication by mouth with or without food as directed||
2197|024|H|by your doctor, usually once daily. The dosage is based on your||
2197|025|H|medical condition and response to treatment.||
2197|026|H|   If needed, you may also crush the tablet(s). Mix the crushed||
2197|027|H|tablet(s) with water (1 ounce or 25 milliliters) in a cup. Swirl||
2197|028|H|to mix and drink the suspension right away. Refill the cup with||
2197|029|H|more water (1 ounce or 25 milliliters) and drink the mixture to||
2197|030|H|make sure you are getting the whole dose. Repeat until there are||
2197|031|H|no more tablet pieces left in the cup. Do not save the mixture||
2197|032|H|for future use.||
2197|033|H|   If you are giving this medication through a feeding tube, ask||
2197|034|H|your health care professional for detailed instructions on how to||
2197|035|H|properly mix and give it.||
2197|036|H|   To reduce your risk of side effects, your doctor may direct||
2197|037|H|you to start this medication at a low dose and gradually increase||
2197|038|H|your dose. Follow your doctor's instructions carefully.||
2197|039|H|   Use this medication regularly to get the most benefit from it.||
2197|040|H|To help you remember, take it at the same time each day.||
2197|041|H|   Do not stop taking this medication without consulting your||
2197|042|H|doctor. Some conditions (such as seizure) may become worse when||
2197|043|H|this drug is suddenly stopped. Also, suddenly stopping this||
2197|044|H|medication may cause withdrawal, especially if you have used it||
2197|045|H|for a long time or in high doses. To prevent withdrawal, your||
2197|046|H|doctor may lower your dose slowly over at least 2 weeks. Tell||
2197|047|H|your doctor or pharmacist right away if you have any withdrawal||
2197|048|H|symptoms such as decreased appetite or mental/mood changes such||
2197|049|H|as depression, loss of memory, trouble sleeping.||
2197|050|H|   Though it helps many people, this medication may sometimes||
2197|051|H|cause addiction. This risk may be higher if you have a substance||
2197|052|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2197|053|H|Take this medication exactly as prescribed to lower the risk of||
2197|054|H|addiction. Ask your doctor or pharmacist for more details.||
2197|055|H|   Keep this medicine in a safe place to prevent theft, misuse,||
2197|056|H|or abuse.||
2197|057|H|   Tell your doctor if your condition does not get better or if||
2197|058|H|it gets worse.||
2197|059|B|||
2197|060|S|SIDE EFFECTS:  Drowsiness, dizziness, tiredness, nausea,||
2197|061|S|vomiting, constipation, decreased appetite, diarrhea, or weakness||
2197|062|S|may occur. If any of these effects last or get worse, tell your||
2197|063|S|doctor or pharmacist promptly.||
2197|064|S|   Remember that this medication has been prescribed because your||
2197|065|S|doctor has judged that the benefit to you is greater than the||
2197|066|S|risk of side effects. Many people using this medication do not||
2197|067|S|have serious side effects.||
2197|068|S|   Tell your doctor right away if you have any serious side||
2197|069|S|effects, including: problems with walking/balance, problems with||
2197|070|S|coordination, vision changes (such as blurred vision, double||
2197|071|S|vision, decreased vision), feeling of spinning (vertigo), trouble||
2197|072|S|reading/speaking/writing, signs of liver disease (such as||
2197|073|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
2197|074|S|yellowing eyes/skin, dark urine).||
2197|075|S|   Get medical help right away if you have any very serious side||
2197|076|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2197|077|S|fainting.||
2197|078|S|   A small number of people who take anticonvulsants for any||
2197|079|S|condition (such as seizure, bipolar disorder, pain) may||
2197|080|S|experience depression, suicidal thoughts/attempts, or other||
2197|081|S|mental/mood problems. Tell your doctor right away if you or your||
2197|082|S|family/caregiver notice any unusual/sudden changes in your mood,||
2197|083|S|thoughts, or behavior such as problems thinking clearly or paying||
2197|084|S|attention, slowed thinking, confusion, memory problems, signs of||
2197|085|S|depression, suicidal thoughts/attempts, thoughts about harming||
2197|086|S|yourself.||
2197|087|S|   A very serious allergic reaction to this drug is rare.||
2197|088|S|However, get medical help right away if you notice any symptoms||
2197|089|S|of a serious allergic reaction, including: fever, swollen lymph||
2197|090|S|nodes, rash, itching/swelling (especially of the||
2197|091|S|face/tongue/throat), severe dizziness, trouble breathing.||
2197|092|S|   This is not a complete list of possible side effects. If you||
2197|093|S|notice other effects not listed above, contact your doctor or||
2197|094|S|pharmacist.||
2197|095|S|   In the US -||
2197|096|S|   Call your doctor for medical advice about side effects. You||
2197|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2197|098|S|www.fda.gov/medwatch.||
2197|099|S|   In Canada - Call your doctor for medical advice about side||
2197|100|S|effects. You may report side effects to Health Canada at||
2197|101|S|1-866-234-2345.||
2197|102|B|||
2197|103|P|PRECAUTIONS:  Before taking cenobamate, tell your doctor or||
2197|104|P|pharmacist if you are allergic to it; or if you have any other||
2197|105|P|allergies. This product may contain inactive ingredients, which||
2197|106|P|can cause allergic reactions or other problems. Talk to your||
2197|107|P|pharmacist for more details.||
2197|108|P|   Before using this medication, tell your doctor or pharmacist||
2197|109|P|your medical history, especially of: kidney problems, liver||
2197|110|P|problems, mental/mood disorders (such as confusion, depression,||
2197|111|P|thoughts of suicide), substance use disorder (such as overuse of||
2197|112|P|or addiction to drugs/alcohol).||
2197|113|P|   Cenobamate may cause a condition that affects the heart rhythm||
2197|114|P|(QT shortening). QT shortening can rarely cause serious (rarely||
2197|115|P|fatal) fast/irregular heartbeat and other symptoms (such as||
2197|116|P|severe dizziness, fainting) that need medical attention right||
2197|117|P|away.||
2197|118|P|   The risk of QT shortening may be increased if you have certain||
2197|119|P|medical conditions or are taking other drugs that may cause QT||
2197|120|P|shortening. Before using cenobamate, tell your doctor or||
2197|121|P|pharmacist of all the drugs you take and if you have any of the||
2197|122|P|following conditions: certain heart problems (irregular||
2197|123|P|heartbeat, QT shortening in the EKG), family history of certain||
2197|124|P|heart problems (QT shortening in the EKG, sudden cardiac death).||
2197|125|P|   This drug may make you dizzy or drowsy or cause blurred||
2197|126|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
2197|127|P|or drowsy. Do not drive, use machinery, or do anything that needs||
2197|128|P|alertness or clear vision until you can do it safely. Limit||
2197|129|P|alcoholic beverages. Talk to your doctor if you are using||
2197|130|P|marijuana (cannabis).||
2197|131|P|   Before having surgery, tell your doctor or dentist about all||
2197|132|P|the products you use (including prescription drugs,||
2197|133|P|nonprescription drugs, and herbal products).||
2197|134|P|   During pregnancy, this medication should be used only when||
2197|135|P|clearly needed. However, since untreated seizures are a serious||
2197|136|P|condition that can harm both a pregnant woman and her unborn||
2197|137|P|baby, do not stop taking this medication unless directed by your||
2197|138|P|doctor. If you are planning pregnancy, become pregnant, or think||
2197|139|P|you may be pregnant, discuss with your doctor right away the||
2197|140|P|benefits and risks of using this medication during pregnancy.||
2197|141|P|Since birth control pills, patches, implants, and injections may||
2197|142|P|not work if used with this medication (see also Drug Interactions||
2197|143|P|section), discuss reliable forms of birth control with your||
2197|144|P|doctor.||
2197|145|P|   It is unknown if this medication passes into breast milk.||
2197|146|P|Consult your doctor before breastfeeding.||
2197|147|B|||
2197|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2197|149|I|medications work or increase your risk for serious side effects.||
2197|150|I|This document does not contain all possible drug interactions.||
2197|151|I|Keep a list of all the products you use (including||
2197|152|I|prescription/nonprescription drugs and herbal products) and share||
2197|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
2197|154|I|the dosage of any medicines without your doctor's approval.||
2197|155|I|   Cenobamate can speed up the removal of other drugs from your||
2197|156|I|body, which may affect how they work. Examples of affected drugs||
2197|157|I|include elacestrant, lonafarnib, mavacamten, quizartinib,||
2197|158|I|revumenib, among others.||
2197|159|I|   This medication may decrease the effectiveness of hormonal||
2197|160|I|birth control such as pills, patch, or ring. This could cause||
2197|161|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2197|162|I|use reliable backup birth control methods while taking this||
2197|163|I|medication. Also tell your doctor if you have any new spotting or||
2197|164|I|breakthrough bleeding, because these may be signs that your birth||
2197|165|I|control is not working well.||
2197|166|I|   Tell your doctor or pharmacist if you are using other products||
2197|167|I|that cause drowsiness such as opioid pain or cough relievers||
2197|168|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2197|169|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2197|170|I|zolpidem), muscle relaxants (such as carisoprodol,||
2197|171|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2197|172|I|diphenhydramine).||
2197|173|I|   Check the labels on all your medicines (such as allergy or||
2197|174|I|cough-and-cold products) because they may contain ingredients||
2197|175|I|that cause drowsiness. Ask your pharmacist about using those||
2197|176|I|products safely.||
2197|177|B|||
2197|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2197|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2197|180|O|poison control center right away. US residents can call||
2197|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2197|182|B|||
2197|183|N|NOTES:  Do not share this medication with others. Sharing it is||
2197|184|N|against the law.||
2197|185|N|   Lab and/or medical tests (such as liver function, potassium||
2197|186|N|blood level) may be done before you start taking this medication||
2197|187|N|and while you are taking it. Keep all medical and lab||
2197|188|N|appointments.||
2197|189|B|||
2197|190|D|MISSED DOSE:  It is important to take each dose of this||
2197|191|D|medication as scheduled. If you miss a dose, ask your doctor or||
2197|192|D|pharmacist right away for a new dosing schedule. Do not double||
2197|193|D|the dose to catch up.||
2197|194|B|||
2197|195|R|STORAGE:  Store at room temperature away from light and moisture.||
2197|196|R|Do not store in the bathroom. Keep all medications away from||
2197|197|R|children and pets.||
2197|198|R|   Do not flush medications down the toilet or pour them into a||
2197|199|R|drain unless instructed to do so. Properly discard this product||
2197|200|R|when it is expired or no longer needed. Consult your pharmacist||
2197|201|R|or local waste disposal company.||
2197|202|B|||
2197|203|M|MEDICAL ALERT:  Your condition can cause complications in a||
2197|204|M|medical emergency. For information about enrolling in MedicAlert,||
2197|205|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2197|206|B|||
2197|207|A|Information last revised August 2025.||
2197|208|A|Copyright(c) 2025 First Databank, Inc.||
2197|209|B|||
2199|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2199|002|Z|does NOT have all possible information about this product. This||
2199|003|Z|information does not assure that this product is safe, effective,||
2199|004|Z|or appropriate for you. This information is not individual||
2199|005|Z|medical advice and does not substitute for the advice of your||
2199|006|Z|health care professional. Always ask your health care||
2199|007|Z|professional for complete information about this product and your||
2199|008|Z|specific health needs.||
2199|009|B|||
2199|010|T|MELOXICAM - INJECTION||
2199|011|F|(mel-OX-i-kam)||
2199|012|B|||
2199|013|C|COMMON BRAND NAME(S): Anjeso||
2199|014|B|||
2199|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
2199|016|W|meloxicam) may rarely increase the risk for a heart attack or||
2199|017|W|stroke. This effect can happen at any time while using this drug||
2199|018|W|but is more likely if you use it for a long time. The risk may be||
2199|019|W|greater in older adults or if you have heart disease or increased||
2199|020|W|risk for heart disease (for example, due to smoking, family||
2199|021|W|history of heart disease, or conditions such as high blood||
2199|022|W|pressure or diabetes). Do not use this drug right before or after||
2199|023|W|heart bypass surgery (CABG).||
2199|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
2199|025|W|bleeding from the stomach or intestines. This effect can occur||
2199|026|W|without warning symptoms at any time while using this drug. Older||
2199|027|W|adults may be at higher risk for this effect.||
2199|028|W|   Stop using meloxicam and get medical help right away if you||
2199|029|W|have any very serious side effects, including: stomach/abdominal||
2199|030|W|pain that doesn't go away, black/tarry stools, vomit that looks||
2199|031|W|like coffee grounds, chest/jaw/left arm pain, shortness of||
2199|032|W|breath, unusual sweating, confusion, weakness on one side of the||
2199|033|W|body, trouble speaking, sudden vision changes.||
2199|034|W|   Talk with your doctor or pharmacist about the benefits and||
2199|035|W|risks of using this drug.||
2199|036|B|||
2199|037|U|USES:  Meloxicam is used to help relieve moderate to severe pain.||
2199|038|U|   Meloxicam is known as a nonsteroidal anti-inflammatory drug||
2199|039|U|(NSAID). It works by blocking your body's production of certain||
2199|040|U|natural substances that cause inflammation. This effect helps to||
2199|041|U|decrease swelling or pain.||
2199|042|B|||
2199|043|H|HOW TO USE:  If you are using this medication at home, learn all||
2199|044|H|preparation and usage instructions from your health care||
2199|045|H|professional.||
2199|046|H|   Before using, check this product for particles or||
2199|047|H|discoloration. If either is present, do not use the liquid.||
2199|048|H|   This medication is given by injection into a vein as directed||
2199|049|H|by your doctor, usually once daily. Meloxicam does not work right||
2199|050|H|away. If quick pain relief is needed, a fast-acting non-NSAID||
2199|051|H|pain medication may be used with this medication as directed by||
2199|052|H|your doctor.||
2199|053|H|   Drink plenty of fluids while using this medication unless your||
2199|054|H|doctor tells you otherwise.||
2199|055|H|   To reduce your risk of stomach bleeding and other side||
2199|056|H|effects, use this medication for the shortest possible time. Do||
2199|057|H|not increase your dose or use this drug more often or for longer||
2199|058|H|than prescribed.||
2199|059|H|   Learn how to store and discard medical supplies safely.||
2199|060|H|   Tell your doctor if your pain lasts or gets worse.||
2199|061|B|||
2199|062|S|SIDE EFFECTS:  See also Warning section.||
2199|063|S|   Dizziness and upset stomach may occur. If either of these||
2199|064|S|effects lasts or gets worse, tell your doctor or pharmacist||
2199|065|S|promptly.||
2199|066|S|   Remember that this medication has been prescribed because your||
2199|067|S|doctor has judged that the benefit to you is greater than the||
2199|068|S|risk of side effects. Many people using this medication do not||
2199|069|S|have serious side effects.||
2199|070|S|   This medication may raise your blood pressure. Check your||
2199|071|S|blood pressure regularly and tell your doctor if the results are||
2199|072|S|high.||
2199|073|S|   Tell your doctor right away if you have any serious side||
2199|074|S|effects, including: easy bruising/bleeding, mental/mood changes,||
2199|075|S|signs of kidney problems (such as change in the amount of urine),||
2199|076|S|symptoms of heart failure (such as swelling ankles/feet, unusual||
2199|077|S|tiredness, unusual/sudden weight gain).||
2199|078|S|   This drug may rarely cause serious (possibly fatal) liver||
2199|079|S|disease. Get medical help right away if you have any symptoms of||
2199|080|S|liver damage, including: nausea/vomiting that doesn't stop,||
2199|081|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
2199|082|S|   A very serious allergic reaction to this drug is rare.||
2199|083|S|However, get medical help right away if you notice any symptoms||
2199|084|S|of a serious allergic reaction, including: fever, swollen lymph||
2199|085|S|nodes, rash, itching/swelling (especially of the||
2199|086|S|face/tongue/throat), severe dizziness, trouble breathing.||
2199|087|S|   This is not a complete list of possible side effects. If you||
2199|088|S|notice other effects not listed above, contact your doctor or||
2199|089|S|pharmacist.||
2199|090|S|   In the US -||
2199|091|S|   Call your doctor for medical advice about side effects. You||
2199|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2199|093|S|www.fda.gov/medwatch.||
2199|094|S|   In Canada - Call your doctor for medical advice about side||
2199|095|S|effects. You may report side effects to Health Canada at||
2199|096|S|1-866-234-2345.||
2199|097|B|||
2199|098|P|PRECAUTIONS:  Before using meloxicam, tell your doctor or||
2199|099|P|pharmacist if you are allergic to it; or to aspirin or other||
2199|100|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
2199|101|P|any other allergies. This product may contain inactive||
2199|102|P|ingredients, which can cause allergic reactions or other||
2199|103|P|problems. Talk to your pharmacist for more details.||
2199|104|P|   Before using this medication, tell your doctor or pharmacist||
2199|105|P|your medical history, especially of: asthma (including a history||
2199|106|P|of worsening breathing after taking aspirin or other NSAIDs),||
2199|107|P|blood disorders (such as anemia), bleeding/clotting problems,||
2199|108|P|growths in the nose (nasal polyps), heart disease (such as||
2199|109|P|previous heart attack), high blood pressure, liver disease,||
2199|110|P|stroke, stomach/intestinal/esophagus problems (such as bleeding,||
2199|111|P|heartburn, ulcers).||
2199|112|P|   Kidney problems can sometimes occur with the use of NSAID||
2199|113|P|medications, including meloxicam. Problems are more likely to||
2199|114|P|occur if you are dehydrated, have heart failure or kidney||
2199|115|P|disease, are an older adult, or if you take certain medications||
2199|116|P|(see also Drug Interactions section). Drink plenty of fluids as||
2199|117|P|directed by your doctor to prevent dehydration and tell your||
2199|118|P|doctor right away if you have any unusual change in the amount of||
2199|119|P|urine.||
2199|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2199|121|P|can make you more dizzy. Do not drive, use machinery, or do||
2199|122|P|anything that needs alertness until you can do it safely. Talk to||
2199|123|P|your doctor if you are using marijuana (cannabis).||
2199|124|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
2199|125|P|and tobacco may increase your risk for stomach bleeding,||
2199|126|P|especially when combined with this medicine. Limit alcohol and||
2199|127|P|stop smoking. Consult your doctor or pharmacist for more||
2199|128|P|information.||
2199|129|P|   Before having surgery, tell your doctor or dentist about all||
2199|130|P|the products you use (including prescription drugs,||
2199|131|P|nonprescription drugs, and herbal products).||
2199|132|P|   This medication may make you more sensitive to the sun. Limit||
2199|133|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2199|134|P|sunscreen and wear protective clothing when outdoors. Tell your||
2199|135|P|doctor right away if you get sunburned or have skin||
2199|136|P|blisters/redness.||
2199|137|P|   Older adults may be at greater risk for stomach/intestinal||
2199|138|P|bleeding, kidney problems, heart attack, and stroke while using||
2199|139|P|this drug.||
2199|140|P|   Before using this medication, women of childbearing age should||
2199|141|P|talk with their doctor(s) about the benefits and risks. Tell your||
2199|142|P|doctor if you are pregnant or if you plan to become pregnant.||
2199|143|P|This medication may harm an unborn baby and cause problems with||
2199|144|P|normal labor/delivery. It is not recommended for use in pregnancy||
2199|145|P|from 20 weeks until delivery. If your doctor decides that you||
2199|146|P|need to use this medication between 20 and 30 weeks of pregnancy,||
2199|147|P|you should use the lowest effective dose for the shortest||
2199|148|P|possible time. You should not use this medication after 30 weeks||
2199|149|P|of pregnancy.||
2199|150|P|   It is unknown if this medication passes into breast milk.||
2199|151|P|Consult your doctor before breastfeeding.||
2199|152|B|||
2199|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2199|154|I|medications work or increase your risk for serious side effects.||
2199|155|I|This document does not contain all possible drug interactions.||
2199|156|I|Keep a list of all the products you use (including||
2199|157|I|prescription/nonprescription drugs and herbal products) and share||
2199|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
2199|159|I|the dosage of any medicines without your doctor's approval.||
2199|160|I|   Some of the products that may interact with this drug are:||
2199|161|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
2199|162|I|angiotensin II receptor blockers (such as losartan, valsartan),||
2199|163|I|cidofovir, lithium, methotrexate (high-dose treatment), "water||
2199|164|I|pills" (diuretics such as furosemide).||
2199|165|I|   This medication may increase the risk of bleeding when used||
2199|166|I|with other drugs that also may cause bleeding. Examples include||
2199|167|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2199|168|I|dabigatran/enoxaparin/warfarin, among others.||
2199|169|I|   Check all prescription and nonprescription medicine labels||
2199|170|I|carefully since many medications contain pain relievers/fever||
2199|171|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
2199|172|I|ketorolac). These drugs are similar to meloxicam and may increase||
2199|173|I|your risk of side effects if taken together. However, if your||
2199|174|I|doctor has told you to take low-dose aspirin to prevent heart||
2199|175|I|attack or stroke (usually 81-162 milligrams a day), you should||
2199|176|I|keep taking the aspirin unless your doctor tells you not to. Ask||
2199|177|I|your doctor or pharmacist for more details.||
2199|178|B|||
2199|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2199|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2199|181|O|poison control center right away. US residents can call||
2199|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2199|183|O|Symptoms of overdose may include: severe stomach pain, vomit that||
2199|184|O|looks like coffee grounds, extreme drowsiness/dizziness.||
2199|185|B|||
2199|186|N|NOTES:  Do not share this medication with others.||
2199|187|N|   Lab and/or medical tests (such as complete blood count,||
2199|188|N|liver/kidney function, blood pressure) may be done while you are||
2199|189|N|using this medication. Keep all medical and lab appointments.||
2199|190|N|   This medication has been prescribed for your current condition||
2199|191|N|only. Do not use it later for another condition unless your||
2199|192|N|doctor tells you to.||
2199|193|B|||
2199|194|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2199|195|D|If it is near the time of the next dose, skip the missed dose.||
2199|196|D|Use your next dose at the regular time. Do not double the dose to||
2199|197|D|catch up.||
2199|198|B|||
2199|199|R|STORAGE:  Store at room temperature away from light. Do not||
2199|200|R|freeze. Keep all medications away from children and pets.||
2199|201|R|   Do not flush medications down the toilet or pour them into a||
2199|202|R|drain unless instructed to do so. Properly discard this product||
2199|203|R|when it is expired or no longer needed. Consult your pharmacist||
2199|204|R|or local waste disposal company.||
2199|205|B|||
2199|206|A|Information last revised December 2024.||
2199|207|A|Copyright(c) 2025 First Databank, Inc.||
2199|208|B|||
2200|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2200|002|Z|does NOT have all possible information about this product. This||
2200|003|Z|information does not assure that this product is safe, effective,||
2200|004|Z|or appropriate for you. This information is not individual||
2200|005|Z|medical advice and does not substitute for the advice of your||
2200|006|Z|health care professional. Always ask your health care||
2200|007|Z|professional for complete information about this product and your||
2200|008|Z|specific health needs.||
2200|009|B|||
2200|010|T|SELUMETINIB - ORAL||
2200|011|F|(SEL-ue-ME-ti-nib)||
2200|012|B|||
2200|013|C|COMMON BRAND NAME(S): Koselugo||
2200|014|B|||
2200|015|U|USES:  Selumetinib is used to treat a type of tumor that grows on||
2200|016|U|nerves (neurofibromatosis type 1). Selumetinib belongs to a class||
2200|017|U|of drugs known as kinase inhibitors. It works by slowing or||
2200|018|U|stopping the growth of tumor cells.||
2200|019|B|||
2200|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2200|021|H|from your pharmacist before you start taking selumetinib and each||
2200|022|H|time you get a refill. If you have any questions, ask your doctor||
2200|023|H|or pharmacist.||
2200|024|H|   Take this medication by mouth with or without food as directed||
2200|025|H|by your doctor, usually twice daily about 12 hours apart. Swallow||
2200|026|H|the capsules whole with water. Do not open, dissolve, or chew the||
2200|027|H|capsules.||
2200|028|H|   If you vomit after taking a dose, do not take another dose at||
2200|029|H|that time. Take your next dose at the regular time.||
2200|030|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2200|031|H|using this medication unless your doctor or pharmacist says you||
2200|032|H|may do so safely. Also avoid eating Seville oranges (often found||
2200|033|H|in marmalade). Grapefruit and Seville oranges can increase the||
2200|034|H|chance of side effects with this medicine. Ask your doctor or||
2200|035|H|pharmacist for more details.||
2200|036|H|   The dosage is based on your body size, medical condition,||
2200|037|H|response to treatment, and other medications you may be taking.||
2200|038|H|Be sure to tell your doctor and pharmacist about all the products||
2200|039|H|you use (including prescription drugs, nonprescription drugs, and||
2200|040|H|herbal products).||
2200|041|H|   Take this medication regularly to get the most benefit from||
2200|042|H|it. To help you remember, take it at the same times each day.||
2200|043|H|   Do not increase your dose or use this drug more often or for||
2200|044|H|longer than prescribed. Your condition will not improve any||
2200|045|H|faster, and your risk of side effects will increase.||
2200|046|H|   Since this drug can be absorbed through the skin and lungs and||
2200|047|H|may harm an unborn baby, women who are pregnant or who may become||
2200|048|H|pregnant should not handle this medication or breathe the dust||
2200|049|H|from the capsules.||
2200|050|B|||
2200|051|S|SIDE EFFECTS:  Nausea, vomiting, tiredness, abdominal pain, or||
2200|052|S|dry skin may occur. If any of these effects last or get worse,||
2200|053|S|tell your doctor or pharmacist promptly.||
2200|054|S|   Diarrhea is a common side effect that can cause dehydration.||
2200|055|S|Tell your doctor right away if you have loose stools, and ask if||
2200|056|S|you should take anti-diarrheal medication (such as loperamide).||
2200|057|S|Drink plenty of fluids to reduce the risk of dehydration. Contact||
2200|058|S|your doctor promptly if you notice any symptoms of dehydration,||
2200|059|S|such as unusual decreased urination, unusual dry mouth/thirst,||
2200|060|S|fast heartbeat, or dizziness/lightheadedness.||
2200|061|S|   People using this medication may have serious side effects.||
2200|062|S|However, you have been prescribed this drug because your doctor||
2200|063|S|has judged that the benefit to you is greater than the risk of||
2200|064|S|side effects. Careful monitoring by your doctor may decrease your||
2200|065|S|risk.||
2200|066|S|   Tell your doctor right away if you have any serious side||
2200|067|S|effects, including: easy bleeding/bruising, muscle||
2200|068|S|pain/tenderness/weakness, signs of heart failure (such as||
2200|069|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
2200|070|S|unusual/sudden weight gain), vision changes (such as blurred||
2200|071|S|vision, decreased vision, seeing halos/colored dots), eye||
2200|072|S|pain/swelling/redness.||
2200|073|S|   A very serious allergic reaction to this drug is rare.||
2200|074|S|However, get medical help right away if you notice any symptoms||
2200|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2200|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2200|077|S|breathing.||
2200|078|S|   This is not a complete list of possible side effects. If you||
2200|079|S|notice other effects not listed above, contact your doctor or||
2200|080|S|pharmacist.||
2200|081|S|   In the US -||
2200|082|S|   Call your doctor for medical advice about side effects. You||
2200|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2200|084|S|www.fda.gov/medwatch.||
2200|085|S|   In Canada - Call your doctor for medical advice about side||
2200|086|S|effects. You may report side effects to Health Canada at||
2200|087|S|1-866-234-2345.||
2200|088|B|||
2200|089|P|PRECAUTIONS:  Before taking selumetinib, tell your doctor or||
2200|090|P|pharmacist if you are allergic to it; or if you have any other||
2200|091|P|allergies. This product may contain inactive ingredients (such as||
2200|092|P|vitamin E), which can cause allergic reactions or other problems.||
2200|093|P|Talk to your pharmacist for more details.||
2200|094|P|   Before using this medication, tell your doctor or pharmacist||
2200|095|P|your medical history, especially of: bleeding/blood problems,||
2200|096|P|heart disease (such as heart failure), eye problems, kidney||
2200|097|P|problems, liver problems.||
2200|098|P|   Before having surgery, tell your doctor or dentist about all||
2200|099|P|the products you use (including prescription drugs,||
2200|100|P|nonprescription drugs, and herbal products).||
2200|101|P|   Since this drug can be absorbed through the skin and lungs and||
2200|102|P|may harm an unborn baby, women who are pregnant or who may become||
2200|103|P|pregnant should not handle this medication or breathe the dust||
2200|104|P|from the capsules.||
2200|105|P|   Tell your doctor if you are pregnant or plan to become||
2200|106|P|pregnant. You should not become pregnant while using selumetinib.||
2200|107|P|Selumetinib may harm an unborn baby. Your doctor should order a||
2200|108|P|pregnancy test before you start this medication. Men and women||
2200|109|P|using this medication should ask about reliable forms of birth||
2200|110|P|control during treatment and for 1 week after the last dose. If||
2200|111|P|you or your partner becomes pregnant, talk to your doctor right||
2200|112|P|away about the risks and benefits of this medication.||
2200|113|P|   It is unknown if this drug passes into breast milk. Because of||
2200|114|P|the possible risk to the infant, breastfeeding is not recommended||
2200|115|P|while using this drug and for 1 week after the last dose. Consult||
2200|116|P|your doctor before breastfeeding.||
2200|117|B|||
2200|118|I|DRUG INTERACTIONS:  See also How to Use section.||
2200|119|I|   Drug interactions may change how your medications work or||
2200|120|I|increase your risk for serious side effects. This document does||
2200|121|I|not contain all possible drug interactions. Keep a list of all||
2200|122|I|the products you use (including prescription/nonprescription||
2200|123|I|drugs and herbal products) and share it with your doctor and||
2200|124|I|pharmacist. Do not start, stop, or change the dosage of any||
2200|125|I|medicines without your doctor's approval.||
2200|126|I|   Some products that may interact with this drug are: other||
2200|127|I|products containing vitamin E.||
2200|128|I|   Other medications can affect the removal of selumetinib from||
2200|129|I|your body, which may affect how selumetinib works. Examples||
2200|130|I|include rifamycins (such as rifampin, rifabutin), St. John's||
2200|131|I|wort, drugs used to treat seizures (such as carbamazepine,||
2200|132|I|phenytoin), among others.||
2200|133|B|||
2200|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2200|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2200|136|O|poison control center right away. US residents can call||
2200|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2200|138|B|||
2200|139|N|NOTES:  Do not share this medication with others.||
2200|140|N|   Lab and/or medical tests (such as heart/kidney/liver function,||
2200|141|N|skin/eye exams, CPK levels) should be done before you start||
2200|142|N|taking this medication and while you are taking it. Keep all||
2200|143|N|medical and lab appointments.||
2200|144|B|||
2200|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2200|146|D|remember. If it is within 6 hours of the next dose, skip the||
2200|147|D|missed dose. Take your next dose at the regular time. Do not||
2200|148|D|double the dose to catch up.||
2200|149|B|||
2200|150|R|STORAGE:  Store in the original bottle at room temperature away||
2200|151|R|from light and moisture. Do not store in the bathroom. Keep the||
2200|152|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
2200|153|R|when not in use. Keep all medications away from children and||
2200|154|R|pets.||
2200|155|R|   Do not flush medications down the toilet or pour them into a||
2200|156|R|drain unless instructed to do so. Properly discard this product||
2200|157|R|when it is expired or no longer needed. Consult your pharmacist||
2200|158|R|or local waste disposal company.||
2200|159|B|||
2200|160|A|Information last revised October 2025.||
2200|161|A|Copyright(c) 2025 First Databank, Inc.||
2200|162|B|||
2201|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2201|002|Z|does NOT have all possible information about this product. This||
2201|003|Z|information does not assure that this product is safe, effective,||
2201|004|Z|or appropriate for you. This information is not individual||
2201|005|Z|medical advice and does not substitute for the advice of your||
2201|006|Z|health care professional. Always ask your health care||
2201|007|Z|professional for complete information about this product and your||
2201|008|Z|specific health needs.||
2201|009|B|||
2201|010|T|OSILODROSTAT - ORAL||
2201|011|F|(oh-SIL-oh-DROE-stat)||
2201|012|B|||
2201|013|C|COMMON BRAND NAME(S): Isturisa||
2201|014|B|||
2201|015|U|USES:  This medication is used to treat a certain hormone problem||
2201|016|U|(Cushing's disease) caused by a tumor in a certain part of the||
2201|017|U|brain (pituitary gland). People with Cushing's disease produce||
2201|018|U|too much of a certain hormone (cortisol). Cortisol is known as a||
2201|019|U|stress hormone and helps your body respond to stress. Having too||
2201|020|U|much cortisol for too long a time can cause various symptoms,||
2201|021|U|which may be different in each person. Osilodrostat works by||
2201|022|U|decreasing the amount of cortisol made by your body. This will||
2201|023|U|help decrease some symptoms caused by having too much cortisol,||
2201|024|U|such as weakness, puffy face, unusual weight gain, slow wound||
2201|025|U|healing, thinning skin, bone pain, menstrual period changes||
2201|026|U|(women), mental/mood changes (such as depression, mood swings,||
2201|027|U|agitation), easy bruising/bleeding, increased thirst/urination,||
2201|028|U|vision problems.||
2201|029|B|||
2201|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2201|031|H|from your pharmacist before you start taking osilodrostat and||
2201|032|H|each time you get a refill. If you have any questions, ask your||
2201|033|H|doctor or pharmacist.||
2201|034|H|   Take this medication by mouth with or without food as directed||
2201|035|H|by your doctor, usually twice daily. The dosage is based on your||
2201|036|H|medical condition, response to treatment, lab tests, and other||
2201|037|H|medications you may be taking. Be sure to tell your doctor and||
2201|038|H|pharmacist about all the products you use (including prescription||
2201|039|H|drugs, nonprescription drugs, and herbal products).||
2201|040|H|   To reduce your risk of side effects, your doctor may direct||
2201|041|H|you to start this medication at a low dose and gradually increase||
2201|042|H|your dose. Follow your doctor's instructions carefully.||
2201|043|H|   Use this medication regularly to get the most benefit from it.||
2201|044|H|To help you remember, take it at the same time(s) each day.||
2201|045|H|   Tell your doctor if your condition does not get better or if||
2201|046|H|it gets worse.||
2201|047|B|||
2201|048|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach/abdominal||
2201|049|S|pain, dizziness, tiredness, headache, muscle ache/pain, or loss||
2201|050|S|of appetite may occur. If any of these effects last or get worse,||
2201|051|S|tell your doctor or pharmacist promptly. Your doctor may change||
2201|052|S|your dose or ask you to stop taking this medication.||
2201|053|S|   Remember that this medication has been prescribed because your||
2201|054|S|doctor has judged that the benefit to you is greater than the||
2201|055|S|risk of side effects. Many people using this medication do not||
2201|056|S|have serious side effects.||
2201|057|S|   Tell your doctor right away if you have any serious side||
2201|058|S|effects, including: swelling ankles/legs.||
2201|059|S|   Get medical help right away if you have any very serious side||
2201|060|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2201|061|S|fainting.||
2201|062|S|   By lowering your cortisol levels, this medication may cause an||
2201|063|S|increase in other hormones in your body (such as testosterone).||
2201|064|S|Tell your doctor right away if you notice symptoms such as||
2201|065|S|swelling, increased blood pressure, or increased hair growth on||
2201|066|S|the body. Women may also have acne and unwanted male-pattern hair||
2201|067|S|growth.||
2201|068|S|   Osilodrostat can commonly cause a mild rash that is usually||
2201|069|S|not serious. However, you may not be able to tell it apart from a||
2201|070|S|rare rash that could be a sign of a severe allergic reaction. Get||
2201|071|S|medical help right away if you develop any rash.||
2201|072|S|   A very serious allergic reaction to this drug is rare.||
2201|073|S|However, get medical help right away if you notice any symptoms||
2201|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2201|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2201|076|S|breathing.||
2201|077|S|   This is not a complete list of possible side effects. If you||
2201|078|S|notice other effects not listed above, contact your doctor or||
2201|079|S|pharmacist.||
2201|080|S|   In the US -||
2201|081|S|   Call your doctor for medical advice about side effects. You||
2201|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2201|083|S|www.fda.gov/medwatch.||
2201|084|S|   In Canada - Call your doctor for medical advice about side||
2201|085|S|effects. You may report side effects to Health Canada at||
2201|086|S|1-866-234-2345.||
2201|087|B|||
2201|088|P|PRECAUTIONS:  Before taking osilodrostat, tell your doctor or||
2201|089|P|pharmacist if you are allergic to it; or if you have any other||
2201|090|P|allergies. This product may contain inactive ingredients, which||
2201|091|P|can cause allergic reactions or other problems. Talk to your||
2201|092|P|pharmacist for more details.||
2201|093|P|   Before using this medication, tell your doctor or pharmacist||
2201|094|P|your medical history, especially of: kidney problems, liver||
2201|095|P|problems.||
2201|096|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2201|097|P|can make you more dizzy. Do not drive, use machinery, or do||
2201|098|P|anything that needs alertness until you can do it safely. Limit||
2201|099|P|alcoholic beverages. Talk to your doctor if you are using||
2201|100|P|marijuana (cannabis).||
2201|101|P|   Osilodrostat may cause a condition that affects the heart||
2201|102|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2201|103|P|serious (rarely fatal) fast/irregular heartbeat and other||
2201|104|P|symptoms (such as severe dizziness, fainting) that need medical||
2201|105|P|attention right away.||
2201|106|P|   The risk of QT prolongation may be increased if you have||
2201|107|P|certain medical conditions or are taking other drugs that may||
2201|108|P|cause QT prolongation. Before using osilodrostat, tell your||
2201|109|P|doctor or pharmacist of all the drugs you take and if you have||
2201|110|P|any of the following conditions: certain heart problems (heart||
2201|111|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2201|112|P|history of certain heart problems (QT prolongation in the EKG,||
2201|113|P|sudden cardiac death).||
2201|114|P|   Low levels of potassium or magnesium in the blood may also||
2201|115|P|increase your risk of QT prolongation. This risk may increase if||
2201|116|P|you use certain drugs (such as diuretics/"water pills") or if you||
2201|117|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2201|118|P|Talk to your doctor about using osilodrostat safely.||
2201|119|P|   Before having surgery, tell your doctor or dentist about all||
2201|120|P|the products you use (including prescription drugs,||
2201|121|P|nonprescription drugs, and herbal products).||
2201|122|P|   Older adults may be more sensitive to the side effects of this||
2201|123|P|drug, especially QT prolongation (see above).||
2201|124|P|   During pregnancy, this medication should be used only when||
2201|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
2201|126|P|   It is unknown if osilodrostat passes into breast milk. Because||
2201|127|P|of the possible risk to the infant, breastfeeding is not||
2201|128|P|recommended while using this medication and for one week after||
2201|129|P|the last dose. Consult your doctor before breastfeeding.||
2201|130|B|||
2201|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2201|132|I|medications work or increase your risk for serious side effects.||
2201|133|I|This document does not contain all possible drug interactions.||
2201|134|I|Keep a list of all the products you use (including||
2201|135|I|prescription/nonprescription drugs and herbal products) and share||
2201|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
2201|137|I|the dosage of any medicines without your doctor's approval.||
2201|138|I|   A product that may interact with this drug is: fezolinetant.||
2201|139|B|||
2201|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2201|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2201|142|O|poison control center right away. US residents can call||
2201|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2201|144|O|Symptoms of overdose may include: nausea, vomiting, low blood||
2201|145|O|pressure, abdominal pain, loss of appetite, fainting.||
2201|146|B|||
2201|147|N|NOTES:  Do not share this medication with others.||
2201|148|N|   Lab and/or medical tests (such as EKG, urine/blood cortisol||
2201|149|N|levels, liver function, blood potassium/magnesium levels, blood||
2201|150|N|pressure) should be done while you are taking this medication.||
2201|151|N|Keep all medical and lab appointments.||
2201|152|B|||
2201|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2201|154|D|remember. If it is near the time of the next dose, skip the||
2201|155|D|missed dose. Take your next dose at the regular time. Do not||
2201|156|D|double the dose to catch up.||
2201|157|B|||
2201|158|R|STORAGE:  Store at room temperature away from light and moisture.||
2201|159|R|Do not store in the bathroom. Keep all medications away from||
2201|160|R|children and pets.||
2201|161|R|   Do not flush medications down the toilet or pour them into a||
2201|162|R|drain unless instructed to do so. Properly discard this product||
2201|163|R|when it is expired or no longer needed. Consult your pharmacist||
2201|164|R|or local waste disposal company.||
2201|165|B|||
2201|166|A|Information last revised May 2024.||
2201|167|A|Copyright(c) 2025 First Databank, Inc.||
2201|168|B|||
2202|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2202|002|Z|does NOT have all possible information about this product. This||
2202|003|Z|information does not assure that this product is safe, effective,||
2202|004|Z|or appropriate for you. This information is not individual||
2202|005|Z|medical advice and does not substitute for the advice of your||
2202|006|Z|health care professional. Always ask your health care||
2202|007|Z|professional for complete information about this product and your||
2202|008|Z|specific health needs.||
2202|009|B|||
2202|010|T|MAGNESIUM CITRATE - ORAL||
2202|011|F|(mag-NEE-zee-um-SYE-trate)||
2202|012|B|||
2202|013|C|COMMON BRAND NAME(S): Citroma||
2202|014|B|||
2202|015|U|USES:  This product is used to clean stool from the intestines||
2202|016|U|before surgery or certain bowel procedures (such as colonoscopy,||
2202|017|U|radiography), usually with other products. It may also be used||
2202|018|U|for relief of constipation. However, milder products (such as||
2202|019|U|stool softeners, bulk-forming laxatives) should be used whenever||
2202|020|U|possible for constipation.||
2202|021|U|   Magnesium citrate is a saline laxative that is thought to work||
2202|022|U|by increasing fluid in the small intestine. It usually results in||
2202|023|U|a bowel movement within 30 minutes to 3 hours.||
2202|024|B|||
2202|025|H|HOW TO USE:  Read and follow all directions on the product||
2202|026|H|package. If your doctor has directed you to use this product||
2202|027|H|before surgery or a bowel procedure, your doctor should tell you||
2202|028|H|how long before the surgery/procedure you should take this||
2202|029|H|product. If you have any questions, ask your doctor or||
2202|030|H|pharmacist. To improve taste, this product may be chilled in the||
2202|031|H|refrigerator before use. Do not freeze.||
2202|032|H|   The dosage is based on your medical condition, age, and||
2202|033|H|response to treatment. Drink a full glass of water (8 ounces or||
2202|034|H|240 milliliters) after taking this product unless otherwise||
2202|035|H|directed by your doctor. Doing so will help prevent serious side||
2202|036|H|effects (such as dehydration).||
2202|037|H|   If this product is used too often, it may cause loss of normal||
2202|038|H|bowel function and an inability to have a bowel movement without||
2202|039|H|using the product (laxative dependence). If you notice symptoms||
2202|040|H|of overuse, such as diarrhea, abdominal pain, decreased weight,||
2202|041|H|or weakness, contact your doctor promptly.||
2202|042|H|   Tell your doctor if this product fails to produce a bowel||
2202|043|H|movement. If you think you may have a serious medical problem,||
2202|044|H|get medical help right away.||
2202|045|B|||
2202|046|S|SIDE EFFECTS:  Mild abdominal discomfort/cramps, gas, or nausea||
2202|047|S|may occur. If any of these effects last or get worse, tell your||
2202|048|S|doctor or pharmacist promptly.||
2202|049|S|   If your doctor has directed you to use this medication,||
2202|050|S|remember that your doctor has judged that the benefit to you is||
2202|051|S|greater than the risk of side effects. Many people using this||
2202|052|S|medication do not have serious side effects.||
2202|053|S|   Tell your doctor right away if you have any serious side||
2202|054|S|effects, including: diarrhea that doesn't stop, stomach/abdominal||
2202|055|S|pain that is severe or doesn't go away, slow/irregular heartbeat,||
2202|056|S|mental/mood changes (such as confusion, unusual drowsiness),||
2202|057|S|muscle weakness, bloody stools, rectal bleeding.||
2202|058|S|   Diarrhea that doesn't stop may result in dehydration. Contact||
2202|059|S|your doctor promptly if you notice any symptoms of dehydration,||
2202|060|S|such as unusual decreased urination, unusual dry mouth/increased||
2202|061|S|thirst, lack of tears, dizziness/lightheadedness, or||
2202|062|S|pale/wrinkled skin.||
2202|063|S|   A very serious allergic reaction to this drug is rare.||
2202|064|S|However, get medical help right away if you notice any symptoms||
2202|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2202|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2202|067|S|breathing.||
2202|068|S|   This is not a complete list of possible side effects. If you||
2202|069|S|notice other effects not listed above, contact your doctor or||
2202|070|S|pharmacist.||
2202|071|S|   In the US -||
2202|072|S|   Call your doctor for medical advice about side effects. You||
2202|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2202|074|S|www.fda.gov/medwatch.||
2202|075|S|   In Canada - Call your doctor for medical advice about side||
2202|076|S|effects. You may report side effects to Health Canada at||
2202|077|S|1-866-234-2345.||
2202|078|B|||
2202|079|P|PRECAUTIONS:  Before taking magnesium citrate, tell your doctor||
2202|080|P|or pharmacist if you are allergic to it; or if you have any other||
2202|081|P|allergies. This product may contain inactive ingredients, which||
2202|082|P|can cause allergic reactions or other problems. Talk to your||
2202|083|P|pharmacist for more details.||
2202|084|P|   Before using this medication, tell your doctor or pharmacist||
2202|085|P|your medical history, especially of: rectal bleeding, bowel||
2202|086|P|problems (such as blockage, ulcerative colitis, hemorrhoids),||
2202|087|P|heart disease (such as irregular heartbeat), kidney disease,||
2202|088|P|current stomach/abdominal symptoms (such as nausea/vomiting that||
2202|089|P|doesn't stop, pain, cramping).||
2202|090|P|   Consult your doctor before using this product if you have had||
2202|091|P|a sudden change in bowel habits lasting more than 2 weeks, or if||
2202|092|P|you need to use a laxative for more than 1 week. These could be||
2202|093|P|symptoms of a serious medical problem.||
2202|094|P|   Before having surgery, tell your doctor or dentist about all||
2202|095|P|the products you use (including prescription drugs,||
2202|096|P|nonprescription drugs, and herbal products).||
2202|097|P|   Children younger than 2 years may be at greater risk for||
2202|098|P|dehydration while using this drug.||
2202|099|P|   During pregnancy, this medication should be used only when||
2202|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
2202|101|P|   This drug passes into breast milk and is unlikely to cause||
2202|102|P|harm to a nursing infant. Consult your doctor before||
2202|103|P|breastfeeding.||
2202|104|B|||
2202|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2202|106|I|medications work or increase your risk for serious side effects.||
2202|107|I|This document does not contain all possible drug interactions.||
2202|108|I|Keep a list of all the products you use (including||
2202|109|I|prescription/nonprescription drugs and herbal products) and share||
2202|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
2202|111|I|the dosage of any medicines without your doctor's approval.||
2202|112|I|   This product can decrease the absorption of certain drugs,||
2202|113|I|especially if you take them around the same time. These drugs||
2202|114|I|include bisphosphonates (such as alendronate), penicillamine,||
2202|115|I|quinolone antibiotics (such as ciprofloxacin, levofloxacin),||
2202|116|I|tetracycline antibiotics (such as doxycycline, minocycline),||
2202|117|I|thyroid medications (such as levothyroxine), among others. Ask||
2202|118|I|your doctor or pharmacist how long you should wait between doses||
2202|119|I|of this product and your other medications and to find a dosing||
2202|120|I|schedule that works for all your medications.||
2202|121|B|||
2202|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2202|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2202|124|O|poison control center right away. US residents can call||
2202|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2202|126|O|Symptoms of overdose may include: muscle weakness, slow/irregular||
2202|127|O|heartbeat, mental/mood changes (such as confusion).||
2202|128|B|||
2202|129|N|NOTES:  Keep all medical and lab appointments.||
2202|130|N|   To maintain normal bowel habits, it is important to drink||
2202|131|N|plenty of fluids (four to six 8-ounce glasses daily), eat foods||
2202|132|N|high in fiber, and exercise regularly.||
2202|133|B|||
2202|134|D|MISSED DOSE:  Not applicable.||
2202|135|B|||
2202|136|R|STORAGE:  Refer to storage information on the package label. If||
2202|137|R|you have any questions about storage, ask your pharmacist. Do not||
2202|138|R|freeze. Do not store in the bathroom. Keep all medications away||
2202|139|R|from children and pets.||
2202|140|R|   Do not flush medications down the toilet or pour them into a||
2202|141|R|drain unless instructed to do so. Properly discard this product||
2202|142|R|when it is expired or no longer needed. Consult your pharmacist||
2202|143|R|or local waste disposal company.||
2202|144|B|||
2202|145|A|Information last revised October 2025.||
2202|146|A|Copyright(c) 2025 First Databank, Inc.||
2202|147|B|||
2203|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2203|002|Z|does NOT have all possible information about this product. This||
2203|003|Z|information does not assure that this product is safe, effective,||
2203|004|Z|or appropriate for you. This information is not individual||
2203|005|Z|medical advice and does not substitute for the advice of your||
2203|006|Z|health care professional. Always ask your health care||
2203|007|Z|professional for complete information about this product and your||
2203|008|Z|specific health needs.||
2203|009|B|||
2203|010|T|PEMIGATINIB - ORAL||
2203|011|F|(PEM-i-GA-ti-nib)||
2203|012|B|||
2203|013|C|COMMON BRAND NAME(S): Pemazyre||
2203|014|B|||
2203|015|U|USES:  This medication is used to treat certain types of cancer||
2203|016|U|(such as bile duct cancer, myeloid/lymphoid neoplasms).||
2203|017|U|Pemigatinib works by slowing or stopping the growth of cancer||
2203|018|U|cells. It belongs to a class of drugs known as kinase inhibitors.||
2203|019|B|||
2203|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2203|021|H|from your pharmacist before you start using pemigatinib and each||
2203|022|H|time you get a refill. If you have any questions, ask your doctor||
2203|023|H|or pharmacist.||
2203|024|H|   Take this medication by mouth with or without food as directed||
2203|025|H|by your doctor. For the treatment of myeloid/lymphoid neoplasms,||
2203|026|H|this medication is usually taken once daily. For the treatment of||
2203|027|H|bile duct cancer, this medication is usually taken in cycles of||
2203|028|H|21 days (once daily for 14 days, then stopping the medication for||
2203|029|H|7 days). Keep taking the medication this way as directed by your||
2203|030|H|doctor.||
2203|031|H|   Swallow the tablets whole. Do not crush, chew, split, or||
2203|032|H|dissolve the tablets.||
2203|033|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2203|034|H|using this medication unless your doctor or pharmacist says you||
2203|035|H|may do so safely. Grapefruit can increase the chance of side||
2203|036|H|effects with this medicine. Ask your doctor or pharmacist for||
2203|037|H|more details.||
2203|038|H|   The dosage is based on your medical condition, response to||
2203|039|H|treatment, and other medications you may be taking. Be sure to||
2203|040|H|tell your doctor and pharmacist about all the products you use||
2203|041|H|(including prescription drugs, nonprescription drugs, and herbal||
2203|042|H|products). If you have certain side effects, your doctor may||
2203|043|H|adjust your dose or stop treatment for some time.||
2203|044|H|   Do not increase your dose or use this drug more often or for||
2203|045|H|longer than prescribed. Your condition will not improve any||
2203|046|H|faster, and your risk of serious side effects will increase.||
2203|047|H|   If you vomit your dose of pemigatinib, do not take another||
2203|048|H|dose. Take your next dose at your regular scheduled time. Do not||
2203|049|H|take two doses at the same time.||
2203|050|H|   Take this medication regularly to get the most benefit from||
2203|051|H|it. To help you remember, take it at the same time each day on||
2203|052|H|the days that you are scheduled to take the medication.||
2203|053|H|   Since this drug can be absorbed through the skin and lungs and||
2203|054|H|may harm an unborn baby, women who are pregnant or who may become||
2203|055|H|pregnant should not handle this medication or breathe the dust||
2203|056|H|from the tablets.||
2203|057|B|||
2203|058|S|SIDE EFFECTS:  Dry eyes, loss of appetite, weight loss, mouth||
2203|059|S|sores, dry mouth, changes in taste, nausea, vomiting, diarrhea,||
2203|060|S|constipation, tiredness/weakness, headache, or dry skin may||
2203|061|S|occur. If any of these effects last or get worse, tell your||
2203|062|S|doctor or pharmacist promptly.||
2203|063|S|   To relieve or prevent dry eyes, use lubricating eye drops or||
2203|064|S|gel (such as artificial tears).||
2203|065|S|   Temporary hair loss may occur. Normal hair growth should||
2203|066|S|return after treatment has ended.||
2203|067|S|   People using this medication may have serious side effects.||
2203|068|S|However, you have been prescribed this drug because your doctor||
2203|069|S|has judged that the benefit to you is greater than the risk of||
2203|070|S|side effects. Careful monitoring by your doctor may decrease your||
2203|071|S|risk.||
2203|072|S|   Tell your doctor right away if you have any serious side||
2203|073|S|effects, including: vision changes (such as blurred vision,||
2203|074|S|seeing floaters/flashes of light), signs of high phosphate levels||
2203|075|S|(such as muscle cramps, mental/mood changes, numbness/tingling||
2203|076|S|around the mouth), nail problems (such as loosening of nail),||
2203|077|S|stomach/abdominal pain, yellowing eyes/skin, signs of kidney||
2203|078|S|problems (such as change in the amount of urine), signs of||
2203|079|S|infection (such as sore throat that doesn't go away, fever,||
2203|080|S|chills), chest pain, shortness of breath, joint pain,||
2203|081|S|tingling/burning/swelling of the hands/feet, signs of dehydration||
2203|082|S|(such as extreme thirst, dizziness, fainting), unusual tiredness,||
2203|083|S|easy bruising/bleeding.||
2203|084|S|   A very serious allergic reaction to this drug is rare.||
2203|085|S|However, get medical help right away if you notice any symptoms||
2203|086|S|of a serious allergic reaction, including: rash, itching/swelling||
2203|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2203|088|S|breathing.||
2203|089|S|   This is not a complete list of possible side effects. If you||
2203|090|S|notice other effects not listed above, contact your doctor or||
2203|091|S|pharmacist.||
2203|092|S|   In the US -||
2203|093|S|   Call your doctor for medical advice about side effects. You||
2203|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2203|095|S|www.fda.gov/medwatch.||
2203|096|S|   In Canada - Call your doctor for medical advice about side||
2203|097|S|effects. You may report side effects to Health Canada at||
2203|098|S|1-866-234-2345.||
2203|099|B|||
2203|100|P|PRECAUTIONS:  Before taking pemigatinib, tell your doctor or||
2203|101|P|pharmacist if you are allergic to it; or if you have any other||
2203|102|P|allergies. This product may contain inactive ingredients, which||
2203|103|P|can cause allergic reactions or other problems. Talk to your||
2203|104|P|pharmacist for more details.||
2203|105|P|   Before using this medication, tell your doctor or pharmacist||
2203|106|P|your medical history, especially of: eye disorders, high level of||
2203|107|P|phosphate in the blood, liver disease, kidney disease.||
2203|108|P|   Before having surgery, tell your doctor or dentist about all||
2203|109|P|the products you use (including prescription drugs,||
2203|110|P|nonprescription drugs, and herbal products).||
2203|111|P|   Since this drug can be absorbed through the skin and lungs and||
2203|112|P|may harm an unborn baby, women who are pregnant or who may become||
2203|113|P|pregnant should not handle this medication or breathe the dust||
2203|114|P|from the tablets.||
2203|115|P|   Tell your doctor if you are pregnant or plan to become||
2203|116|P|pregnant. You should not become pregnant while using pemigatinib.||
2203|117|P|Pemigatinib may harm an unborn baby. Your doctor should order a||
2203|118|P|pregnancy test before you start this medication. Men and women||
2203|119|P|using this medication should ask about reliable forms of birth||
2203|120|P|control during treatment and for 1 week after the last dose. If||
2203|121|P|you or your partner becomes pregnant, talk to your doctor right||
2203|122|P|away about the risks and benefits of this medication.||
2203|123|P|   It is unknown if this drug passes into breast milk. Because of||
2203|124|P|the possible risk to the infant, breastfeeding is not recommended||
2203|125|P|while using this drug and for 1 week after the last dose. Consult||
2203|126|P|your doctor before breastfeeding.||
2203|127|B|||
2203|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2203|129|I|medications work or increase your risk for serious side effects.||
2203|130|I|This document does not contain all possible drug interactions.||
2203|131|I|Keep a list of all the products you use (including||
2203|132|I|prescription/nonprescription drugs and herbal products) and share||
2203|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
2203|134|I|the dosage of any medicines without your doctor's approval.||
2203|135|I|   Other medications can affect the removal of pemigatinib from||
2203|136|I|your body, which may affect how pemigatinib works. Examples||
2203|137|I|include rifamycins (such as rifampin, rifabutin), drugs to treat||
2203|138|I|seizures (such as phenytoin, carbamazepine, phenobarbital), St.||
2203|139|I|John's wort, among others.||
2203|140|B|||
2203|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2203|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2203|143|O|poison control center right away. US residents can call||
2203|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2203|145|B|||
2203|146|N|NOTES:  Do not share this medication with others.||
2203|147|N|   Lab and/or medical tests (such as eye exam, blood mineral||
2203|148|N|levels, liver/kidney function, complete blood counts) should be||
2203|149|N|done before you start taking this medication and while you are||
2203|150|N|taking it. Keep all medical and lab appointments.||
2203|151|B|||
2203|152|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2203|153|D|remember. If it is more than 4 hours after the missed dose, skip||
2203|154|D|the missed dose. Take your next dose at the regular time. Do not||
2203|155|D|double the dose to catch up.||
2203|156|B|||
2203|157|R|STORAGE:  Store at room temperature away from light and moisture.||
2203|158|R|Do not store in the bathroom. Keep all medications away from||
2203|159|R|children and pets.||
2203|160|R|   Do not flush medications down the toilet or pour them into a||
2203|161|R|drain unless instructed to do so. Properly discard this product||
2203|162|R|when it is expired or no longer needed. Consult your pharmacist||
2203|163|R|or local waste disposal company.||
2203|164|B|||
2203|165|A|Information last revised April 2025.||
2203|166|A|Copyright(c) 2025 First Databank, Inc.||
2203|167|B|||
2204|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2204|002|Z|does NOT have all possible information about this product. This||
2204|003|Z|information does not assure that this product is safe, effective,||
2204|004|Z|or appropriate for you. This information is not individual||
2204|005|Z|medical advice and does not substitute for the advice of your||
2204|006|Z|health care professional. Always ask your health care||
2204|007|Z|professional for complete information about this product and your||
2204|008|Z|specific health needs.||
2204|009|B|||
2204|010|T|FEXOFENADINE - ORAL||
2204|011|F|(fex-oh-FEN-uh-deen)||
2204|012|B|||
2204|013|C|COMMON BRAND NAME(S): Allegra||
2204|014|B|||
2204|015|U|USES:  Fexofenadine is an antihistamine used to relieve allergy||
2204|016|U|symptoms such as watery eyes, runny nose, itching eyes/nose,||
2204|017|U|sneezing, hives, and itching. It works by blocking a certain||
2204|018|U|natural substance (histamine) that your body makes during an||
2204|019|U|allergic reaction.||
2204|020|B|||
2204|021|H|HOW TO USE:  If you are taking the over-the-counter product to||
2204|022|H|self-treat, read all directions on the product package before||
2204|023|H|taking this medication. If you have any questions, consult your||
2204|024|H|pharmacist. If your doctor has prescribed this medication, take||
2204|025|H|it as directed, usually 2 times daily (every 12 hours).||
2204|026|H|   If you are using the liquid form of this medication, shake the||
2204|027|H|bottle well before each dose and measure the dose carefully using||
2204|028|H|a special measuring device/spoon. Do not use a household spoon||
2204|029|H|because you may not get the correct dose. Take the tablet/capsule||
2204|030|H|or liquid form of this medication with or without food. If you||
2204|031|H|are using the rapidly-dissolving tablet, take it on an empty||
2204|032|H|stomach. Allow the rapidly-dissolving tablet to dissolve on the||
2204|033|H|tongue and then swallow, with or without water. Do not remove the||
2204|034|H|tablet from the blister pack until right before using.||
2204|035|H|   If you need a liquid to take this medication (such as when||
2204|036|H|taking the tablets/capsules), then take this medication with||
2204|037|H|water. Do not take with fruit juices (such as apple, grapefruit,||
2204|038|H|or orange) since they may decrease the absorption of this drug.||
2204|039|H|   The dosage is based on your age, medical condition, and||
2204|040|H|response to treatment. Do not increase your dose or take this||
2204|041|H|medication more often than directed.||
2204|042|H|   Do not take antacids containing aluminum and magnesium within||
2204|043|H|2 hours of taking this medication. These antacids can decrease||
2204|044|H|the absorption of fexofenadine.||
2204|045|H|   Tell your doctor if your condition does not get better or if||
2204|046|H|it gets worse.||
2204|047|B|||
2204|048|S|SIDE EFFECTS:  Cough, fever, or stomach upset may occur. If any||
2204|049|S|of these effects last or get worse, tell your doctor or||
2204|050|S|pharmacist promptly.||
2204|051|S|   If your doctor has prescribed this medication, remember that||
2204|052|S|your doctor has judged that the benefit to you is greater than||
2204|053|S|the risk of side effects. Many people using this medication do||
2204|054|S|not have serious side effects.||
2204|055|S|   A very serious allergic reaction to this drug is rare.||
2204|056|S|However, get medical help right away if you notice any symptoms||
2204|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2204|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2204|059|S|breathing.||
2204|060|S|   This is not a complete list of possible side effects. If you||
2204|061|S|notice other effects not listed above, contact your doctor or||
2204|062|S|pharmacist.||
2204|063|S|   In the US -||
2204|064|S|   Call your doctor for medical advice about side effects. You||
2204|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2204|066|S|www.fda.gov/medwatch.||
2204|067|S|   In Canada - Call your doctor for medical advice about side||
2204|068|S|effects. You may report side effects to Health Canada at||
2204|069|S|1-866-234-2345.||
2204|070|B|||
2204|071|P|PRECAUTIONS:  Before taking fexofenadine, tell your doctor or||
2204|072|P|pharmacist if you are allergic to it; or if you have any other||
2204|073|P|allergies. This product may contain inactive ingredients, which||
2204|074|P|can cause allergic reactions or other problems. Talk to your||
2204|075|P|pharmacist for more details.||
2204|076|P|   Before using this medication, tell your doctor or pharmacist||
2204|077|P|your medical history, especially of: kidney disease.||
2204|078|P|   Before having surgery, tell your doctor or dentist about all||
2204|079|P|the products you use (including prescription drugs,||
2204|080|P|nonprescription drugs, and herbal products).||
2204|081|P|   Liquid products may contain sugar. The rapidly-dissolving||
2204|082|P|tablets may contain aspartame. Caution is advised if you have||
2204|083|P|diabetes, phenylketonuria (PKU), or any other condition that||
2204|084|P|requires you to limit/avoid these substances in your diet. Ask||
2204|085|P|your doctor or pharmacist about using this product safely.||
2204|086|P|   During pregnancy, this medication should be used only when||
2204|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
2204|088|P|   This medication passes into breast milk. Consult your doctor||
2204|089|P|before breastfeeding.||
2204|090|B|||
2204|091|I|DRUG INTERACTIONS:  See also How to Use section.||
2204|092|I|   Drug interactions may change how your medications work or||
2204|093|I|increase your risk for serious side effects. This document does||
2204|094|I|not contain all possible drug interactions. Keep a list of all||
2204|095|I|the products you use (including prescription/nonprescription||
2204|096|I|drugs and herbal products) and share it with your doctor and||
2204|097|I|pharmacist. Do not start, stop, or change the dosage of any||
2204|098|I|medicines without your doctor's approval.||
2204|099|I|   This medication may interfere with certain lab tests (such as||
2204|100|I|allergy skin testing), possibly causing false test results. Make||
2204|101|I|sure lab personnel and all your doctors know you use this drug.||
2204|102|B|||
2204|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2204|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2204|105|O|poison control center right away. US residents can call||
2204|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2204|107|B|||
2204|108|N|NOTES:  Keep all medical and lab appointments.||
2204|109|B|||
2204|110|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2204|111|D|remember. If it is near the time of the next dose, skip the||
2204|112|D|missed dose. Take your next dose at the regular time. Do not||
2204|113|D|double the dose to catch up.||
2204|114|B|||
2204|115|R|STORAGE:  Store at room temperature away from light and moisture.||
2204|116|R|Do not store in the bathroom. Different brands of this medication||
2204|117|R|may have different storage needs. Check the product package for||
2204|118|R|instructions on how to store your brand, or ask your pharmacist.||
2204|119|R|Keep all medications away from children and pets.||
2204|120|R|   Do not flush medications down the toilet or pour them into a||
2204|121|R|drain unless instructed to do so. Properly discard this product||
2204|122|R|when it is expired or no longer needed. Consult your pharmacist||
2204|123|R|or local waste disposal company.||
2204|124|B|||
2204|125|A|Information last revised October 2024.||
2204|126|A|Copyright(c) 2025 First Databank, Inc.||
2204|127|B|||
2205|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2205|002|Z|does NOT have all possible information about this product. This||
2205|003|Z|information does not assure that this product is safe, effective,||
2205|004|Z|or appropriate for you. This information is not individual||
2205|005|Z|medical advice and does not substitute for the advice of your||
2205|006|Z|health care professional. Always ask your health care||
2205|007|Z|professional for complete information about this product and your||
2205|008|Z|specific health needs.||
2205|009|B|||
2205|010|T|TUCATINIB - ORAL||
2205|011|F|(too-KA-ti-nib)||
2205|012|B|||
2205|013|C|COMMON BRAND NAME(S): Tukysa||
2205|014|B|||
2205|015|U|USES:  This medication is used to treat certain types of breast,||
2205|016|U|colon, or rectum cancers. Tucatinib belongs to a class of drugs||
2205|017|U|known as kinase inhibitors. It works by slowing or stopping the||
2205|018|U|growth of cancer cells.||
2205|019|B|||
2205|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2205|021|H|from your pharmacist before you start taking tucatinib and each||
2205|022|H|time you get a refill. If you have any questions, ask your doctor||
2205|023|H|or pharmacist.||
2205|024|H|   Take this medication by mouth with or without food as directed||
2205|025|H|by your doctor, usually twice daily (about 12 hours apart).||
2205|026|H|Swallow the medication whole. Do not chew, crush, or split the||
2205|027|H|tablets. Do not take tablets if they are broken, cracked, or||
2205|028|H|damaged.||
2205|029|H|   If you miss a dose or vomit after taking tucatinib, do not||
2205|030|H|take another dose. Take your next dose at the regular time.||
2205|031|H|   Use this medication regularly to get the most benefit from it.||
2205|032|H|To help you remember, take it at the same times each day.||
2205|033|H|   The dosage is based on your medical condition and response to||
2205|034|H|treatment. Do not increase your dose or use this drug more often||
2205|035|H|or for longer than prescribed. Your condition will not improve||
2205|036|H|any faster, and your risk of serious side effects will increase.||
2205|037|H|   Since this drug can be absorbed through the skin and lungs and||
2205|038|H|may harm an unborn baby, women who are pregnant or who may become||
2205|039|H|pregnant should not handle this medication or breathe the dust||
2205|040|H|from the tablets.||
2205|041|B|||
2205|042|S|SIDE EFFECTS:  Nausea, vomiting, mouth sores/pain, loss of||
2205|043|S|appetite, weight loss, tiredness, or muscle/joint pain may occur.||
2205|044|S|If any of these effects last or get worse, tell your doctor or||
2205|045|S|pharmacist promptly.||
2205|046|S|   Diarrhea is a common side effect and can sometimes be severe.||
2205|047|S|Vomiting/diarrhea that doesn't stop may result in dehydration.||
2205|048|S|Contact your doctor promptly if you notice any symptoms of||
2205|049|S|dehydration, such as unusual decreased urination, unusual dry||
2205|050|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness. Your||
2205|051|S|doctor may prescribe anti-diarrheal medication to take during||
2205|052|S|treatment with this medication.||
2205|053|S|   People using this medication may have serious side effects.||
2205|054|S|However, you have been prescribed this drug because your doctor||
2205|055|S|has judged that the benefit to you is greater than the risk of||
2205|056|S|side effects. Careful monitoring by your doctor may decrease your||
2205|057|S|risk.||
2205|058|S|   Tucatinib may make you develop a skin problem called hand-foot||
2205|059|S|syndrome. To help prevent this, protect your hands and feet from||
2205|060|S|heat or increased pressure. Avoid activities such as using hot||
2205|061|S|dishwater, taking tub baths, jogging, going on long walks, or||
2205|062|S|using garden or household tools such as screwdrivers. Symptoms||
2205|063|S|may include pain, swelling, redness, blisters, or numbness of the||
2205|064|S|hands/feet. Your doctor may prescribe medication (such as balm)||
2205|065|S|to help with symptoms. If symptoms affect your usual activities,||
2205|066|S|get medical help right away.||
2205|067|S|   Tucatinib may rarely cause serious (possibly fatal) liver||
2205|068|S|disease. Your doctor should check liver function tests before you||
2205|069|S|start taking this medication and every 3 weeks during treatment,||
2205|070|S|or as needed. Get medical help right away if you have any||
2205|071|S|symptoms of liver damage, such as: nausea/vomiting that doesn't||
2205|072|S|stop, stomach/abdominal pain, yellowing eyes/skin, dark urine.||
2205|073|S|   A very serious allergic reaction to this drug is rare.||
2205|074|S|However, get medical help right away if you notice any symptoms||
2205|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2205|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2205|077|S|breathing.||
2205|078|S|   This is not a complete list of possible side effects. If you||
2205|079|S|notice other effects not listed above, contact your doctor or||
2205|080|S|pharmacist.||
2205|081|S|   In the US -||
2205|082|S|   Call your doctor for medical advice about side effects. You||
2205|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2205|084|S|www.fda.gov/medwatch.||
2205|085|S|   In Canada - Call your doctor for medical advice about side||
2205|086|S|effects. You may report side effects to Health Canada at||
2205|087|S|1-866-234-2345.||
2205|088|B|||
2205|089|P|PRECAUTIONS:  Before taking tucatinib, tell your doctor or||
2205|090|P|pharmacist if you are allergic to it; or if you have any other||
2205|091|P|allergies. This product may contain inactive ingredients, which||
2205|092|P|can cause allergic reactions or other problems. Talk to your||
2205|093|P|pharmacist for more details.||
2205|094|P|   Before using this medication, tell your doctor or pharmacist||
2205|095|P|your medical history, especially of: kidney disease, liver||
2205|096|P|problems.||
2205|097|P|   Before having surgery, tell your doctor or dentist about all||
2205|098|P|the products you use (including prescription drugs,||
2205|099|P|nonprescription drugs, and herbal products).||
2205|100|P|   Since this drug can be absorbed through the skin and lungs and||
2205|101|P|may harm an unborn baby, women who are pregnant or who may become||
2205|102|P|pregnant should not handle this medication or breathe the dust||
2205|103|P|from the tablets.||
2205|104|P|   Tell your doctor if you are pregnant or plan to become||
2205|105|P|pregnant. You should not become pregnant while using tucatinib.||
2205|106|P|Tucatinib may harm an unborn baby. Your doctor should order a||
2205|107|P|pregnancy test before you start this medication. Men and women||
2205|108|P|using this medication should ask about reliable forms of birth||
2205|109|P|control during treatment and for at least 1 week after the last||
2205|110|P|dose. If you or your partner becomes pregnant, talk to your||
2205|111|P|doctor right away about the risks and benefits of this||
2205|112|P|medication.||
2205|113|P|   It is unknown if this medication passes into breast milk.||
2205|114|P|Because of the possible risk to the infant, breastfeeding is not||
2205|115|P|recommended while using this medication and for at least 1 week||
2205|116|P|after the last dose. Consult your doctor before breastfeeding.||
2205|117|B|||
2205|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2205|119|I|medications work or increase your risk for serious side effects.||
2205|120|I|This document does not contain all possible drug interactions.||
2205|121|I|Keep a list of all the products you use (including||
2205|122|I|prescription/nonprescription drugs and herbal products) and share||
2205|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
2205|124|I|the dosage of any medicines without your doctor's approval.||
2205|125|I|   Other medications can affect the removal of tucatinib from||
2205|126|I|your body, which may affect how tucatinib works. Examples include||
2205|127|I|rifamycins (such as rifabutin, rifampin), St. John's wort, drugs||
2205|128|I|used to treat seizures (such as carbamazepine, phenytoin), among||
2205|129|I|others.||
2205|130|I|   This medication can slow down the removal of other medications||
2205|131|I|from your body, which may affect how they work. Examples of||
2205|132|I|affected drugs include avanafil, some benzodiazepines (such as||
2205|133|I|midazolam, triazolam), daridorexant, ergot drugs (such as||
2205|134|I|ergotamine, dihydroergotamine), finerenone, mavacamten,||
2205|135|I|pacritinib, some "statin" drugs (such as lovastatin,||
2205|136|I|simvastatin), ubrogepant, among others.||
2205|137|B|||
2205|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2205|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2205|140|O|poison control center right away. US residents can call||
2205|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2205|142|B|||
2205|143|N|NOTES:  Do not share this medication with others.||
2205|144|N|   Lab and/or medical tests (such as complete blood count,||
2205|145|N|kidney/liver function) should be done before you start taking||
2205|146|N|this medication and while you are taking it. Keep all medical and||
2205|147|N|lab appointments.||
2205|148|B|||
2205|149|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2205|150|D|next dose at the regular time. Do not double the dose to catch||
2205|151|D|up.||
2205|152|B|||
2205|153|R|STORAGE:  Store in the original container at room temperature||
2205|154|R|away from light and moisture. Do not store in the bathroom. Keep||
2205|155|R|the drying agent (desiccant) in the bottle. Tightly close the||
2205|156|R|bottle when not in use. Once the bottle is opened, this||
2205|157|R|medication expires after 3 months. Keep all medications away from||
2205|158|R|children and pets.||
2205|159|R|   Do not flush medications down the toilet or pour them into a||
2205|160|R|drain unless instructed to do so. Properly discard this product||
2205|161|R|when it is expired or no longer needed. Consult your pharmacist||
2205|162|R|or local waste disposal company.||
2205|163|B|||
2205|164|A|Information last revised July 2024.||
2205|165|A|Copyright(c) 2025 First Databank, Inc.||
2205|166|B|||
2207|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2207|002|Z|does NOT have all possible information about this product. This||
2207|003|Z|information does not assure that this product is safe, effective,||
2207|004|Z|or appropriate for you. This information is not individual||
2207|005|Z|medical advice and does not substitute for the advice of your||
2207|006|Z|health care professional. Always ask your health care||
2207|007|Z|professional for complete information about this product and your||
2207|008|Z|specific health needs.||
2207|009|B|||
2207|010|T|ZOLMITRIPTAN DISINTEGRATING TABLET - ORAL||
2207|011|F|(ZOLE-mi-TRIP-tan)||
2207|012|B|||
2207|013|C|COMMON BRAND NAME(S): Zomig ZMT||
2207|014|B|||
2207|015|U|USES:  Zolmitriptan is used to treat migraines. It helps to||
2207|016|U|relieve headache, pain, and other migraine symptoms (including||
2207|017|U|nausea, vomiting, sensitivity to light/sound). Prompt treatment||
2207|018|U|helps you return to your normal routine and may decrease your||
2207|019|U|need for other pain medications. Zolmitriptan belongs to a class||
2207|020|U|of drugs known as triptans. It affects a certain natural||
2207|021|U|substance (serotonin) that causes narrowing of blood vessels in||
2207|022|U|the brain. It may also relieve pain by affecting certain nerves||
2207|023|U|in the brain.||
2207|024|U|   Zolmitriptan does not prevent future migraines or lessen how||
2207|025|U|often you get migraine attacks.||
2207|026|B|||
2207|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2207|028|H|from your pharmacist before you start taking zolmitriptan and||
2207|029|H|each time you get a refill. If you have any questions, ask your||
2207|030|H|doctor or pharmacist.||
2207|031|H|   At the first sign of a migraine, open the blister pack with||
2207|032|H|clean and dry hands and place the tablet on your tongue as||
2207|033|H|directed by your doctor. The tablet will quickly dissolve and can||
2207|034|H|be swallowed with your saliva. You do not need to take this||
2207|035|H|medication with water or other liquid.||
2207|036|H|   Do not break or crush the tablets. Do not remove any tablets||
2207|037|H|from the original packaging until you are ready to take your||
2207|038|H|dose. Doing so could decrease the effectiveness of this||
2207|039|H|medication.||
2207|040|H|   If there is no improvement in your symptoms, do not take more||
2207|041|H|doses of this medication before talking to your doctor. If your||
2207|042|H|symptoms are only partly relieved, or if your headache comes||
2207|043|H|back, you may take another dose at least two hours after the||
2207|044|H|first dose. Do not take more than 10 milligrams in a 24-hour||
2207|045|H|period.||
2207|046|H|   The dosage is based on your medical condition, response to||
2207|047|H|treatment, and other medications you may be taking. Be sure to||
2207|048|H|tell your doctor about all the products you use, including||
2207|049|H|prescription drugs, nonprescription drugs, and herbal products.||
2207|050|H|   If you have a higher risk for heart problems (see||
2207|051|H|Precautions), your doctor may perform a heart exam before you||
2207|052|H|start taking zolmitriptan. He/she may also direct you to take||
2207|053|H|your first dose of this medication in the office/clinic to||
2207|054|H|monitor for serious side effects (such as chest pain). Talk to||
2207|055|H|your doctor for details.||
2207|056|H|   If you are using drugs for migraine attacks on 10 or more days||
2207|057|H|each month, the drugs may actually make your headaches worse||
2207|058|H|(medication overuse headache). Do not use medications more often||
2207|059|H|or for longer than directed. Tell your doctor if you need to use||
2207|060|H|this medication more often, or if the medication is not working||
2207|061|H|as well, or if your headaches get worse.||
2207|062|B|||
2207|063|S|SIDE EFFECTS:  Tingling/numbness, nausea, dry mouth, weakness,||
2207|064|S|drowsiness, or dizziness may occur. If any of these effects last||
2207|065|S|or get worse, tell your doctor or pharmacist promptly.||
2207|066|S|   Remember that this medication has been prescribed because your||
2207|067|S|doctor has judged that the benefit to you is greater than the||
2207|068|S|risk of side effects. Many people using this medication do not||
2207|069|S|have serious side effects.||
2207|070|S|   This medication may raise your blood pressure. Check your||
2207|071|S|blood pressure regularly and tell your doctor if the results are||
2207|072|S|high.||
2207|073|S|   Tell your doctor right away if you have any serious side||
2207|074|S|effects, including: blue fingers/toes/nails, cold hands/feet.||
2207|075|S|   Zolmitriptan can commonly cause chest/jaw/neck tightness,||
2207|076|S|pain, or pressure that is usually not serious. However, these||
2207|077|S|side effects are like symptoms of a heart attack, which may||
2207|078|S|include chest/jaw/left arm pain, shortness of breath, or unusual||
2207|079|S|sweating. Get medical help right away if these or other serious||
2207|080|S|side effects occur, including: fast/irregular heartbeat,||
2207|081|S|fainting, severe stomach/abdominal pain, bloody diarrhea, signs||
2207|082|S|of a stroke (such as weakness on one side of the body, trouble||
2207|083|S|speaking, sudden vision changes, confusion).||
2207|084|S|   This medication may increase serotonin and rarely cause a very||
2207|085|S|serious condition called serotonin syndrome/toxicity. The risk||
2207|086|S|increases if you are also taking other drugs that increase||
2207|087|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2207|088|S|take (see Drug Interactions section). Get medical help right away||
2207|089|S|if you develop some of the following symptoms: fast heartbeat,||
2207|090|S|hallucinations, loss of coordination, severe dizziness, severe||
2207|091|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2207|092|S|unusual agitation/restlessness.||
2207|093|S|   A very serious allergic reaction to this drug is rare.||
2207|094|S|However, get medical help right away if you notice any symptoms||
2207|095|S|of a serious allergic reaction, including: rash, itching/swelling||
2207|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2207|097|S|breathing.||
2207|098|S|   This is not a complete list of possible side effects. If you||
2207|099|S|notice other effects not listed above, contact your doctor or||
2207|100|S|pharmacist.||
2207|101|S|   In the US -||
2207|102|S|   Call your doctor for medical advice about side effects. You||
2207|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2207|104|S|www.fda.gov/medwatch.||
2207|105|S|   In Canada - Call your doctor for medical advice about side||
2207|106|S|effects. You may report side effects to Health Canada at||
2207|107|S|1-866-234-2345.||
2207|108|B|||
2207|109|P|PRECAUTIONS:  Before using zolmitriptan, tell your doctor or||
2207|110|P|pharmacist if you are allergic to it; or if you have any other||
2207|111|P|allergies. This product may contain inactive ingredients, which||
2207|112|P|can cause allergic reactions or other problems. Talk to your||
2207|113|P|pharmacist for more details.||
2207|114|P|   Before using this medication, tell your doctor or pharmacist||
2207|115|P|your medical history, especially of: blood circulation problems||
2207|116|P|(for example, in your legs, arms/hands, or stomach), certain||
2207|117|P|types of headaches (hemiplegic or basilar migraine), heart||
2207|118|P|problems (such as chest pain, irregular heartbeat, previous heart||
2207|119|P|attack), liver disease, seizure, stroke or "mini-stroke"||
2207|120|P|(transient ischemic attack).||
2207|121|P|   Certain conditions can increase your risk for heart problems.||
2207|122|P|Tell your doctor if you have any of these conditions, including:||
2207|123|P|high blood pressure, high cholesterol, diabetes, family history||
2207|124|P|of heart disease, overweight, smoker, postmenopausal (women), age||
2207|125|P|more than 40 years (men).||
2207|126|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2207|127|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2207|128|P|machinery, or do anything that needs alertness until you can do||
2207|129|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2207|130|P|are using marijuana (cannabis).||
2207|131|P|   This medication may contain aspartame. If you have||
2207|132|P|phenylketonuria (PKU) or any other condition that requires you to||
2207|133|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
2207|134|P|doctor or pharmacist about using this medication safely.||
2207|135|P|   Before having surgery, tell your doctor or dentist about all||
2207|136|P|the products you use (including prescription drugs,||
2207|137|P|nonprescription drugs, and herbal products).||
2207|138|P|   The risk of heart disease, liver disease, and high blood||
2207|139|P|pressure increases with age. Older adults may be more sensitive||
2207|140|P|to the side effects of this drug, especially increased blood||
2207|141|P|pressure and heart problems.||
2207|142|P|   During pregnancy, this medication should be used only when||
2207|143|P|clearly needed. Discuss the risks and benefits with your doctor.||
2207|144|P|   It is unknown if this drug passes into breast milk. Consult||
2207|145|P|your doctor before breastfeeding.||
2207|146|B|||
2207|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2207|148|I|medications work or increase your risk for serious side effects.||
2207|149|I|This document does not contain all possible drug interactions.||
2207|150|I|Keep a list of all the products you use (including||
2207|151|I|prescription/nonprescription drugs and herbal products) and share||
2207|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
2207|153|I|the dosage of any medicines without your doctor's approval.||
2207|154|I|   Taking MAO inhibitors with this medication may cause a serious||
2207|155|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
2207|156|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2207|157|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2207|158|I|selegiline, tranylcypromine) during treatment with this||
2207|159|I|medication. Most MAO inhibitors should also not be taken for two||
2207|160|I|weeks before treatment with this medication. Ask your doctor when||
2207|161|I|to start or stop taking this medication.||
2207|162|I|   The risk of serotonin syndrome/toxicity increases if you are||
2207|163|I|also taking other drugs that increase serotonin. Examples include||
2207|164|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
2207|165|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2207|166|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2207|167|I|serotonin syndrome/toxicity may be more likely when you start or||
2207|168|I|increase the dose of these drugs.||
2207|169|I|   If you also take any ergotamine medication (such as||
2207|170|I|dihydroergotamine) or other "triptan" drugs (such as sumatriptan,||
2207|171|I|rizatriptan), you will need to separate your zolmitriptan dose||
2207|172|I|from your dose of these other medications to lessen the chance of||
2207|173|I|serious side effects. Ask your doctor how long you should wait||
2207|174|I|between your doses of these drugs.||
2207|175|B|||
2207|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2207|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2207|178|O|poison control center right away. US residents can call||
2207|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2207|180|B|||
2207|181|N|NOTES:  Do not share this medication with others.||
2207|182|N|   Certain foods, beverages, or food additives (such as red wine,||
2207|183|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
2207|184|N|patterns such as irregular eating/sleeping habits or stress may||
2207|185|N|bring on a migraine headache. Avoiding these "triggers" may help||
2207|186|N|lessen migraine attacks. Consult your doctor for more details.||
2207|187|N|   Lab and/or medical tests (such as blood pressure) may be done||
2207|188|N|while you are taking this medication. Keep all medical and lab||
2207|189|N|appointments. Consult your doctor for more details.||
2207|190|B|||
2207|191|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
2207|192|B|||
2207|193|R|STORAGE:  Store at room temperature away from light and moisture.||
2207|194|R|Do not store in the bathroom. Keep all medications away from||
2207|195|R|children and pets.||
2207|196|R|   Do not flush medications down the toilet or pour them into a||
2207|197|R|drain unless instructed to do so. Properly discard this product||
2207|198|R|when it is expired or no longer needed. Consult your pharmacist||
2207|199|R|or local waste disposal company.||
2207|200|B|||
2207|201|A|Information last revised May 2024.||
2207|202|A|Copyright(c) 2025 First Databank, Inc.||
2207|203|B|||
2208|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2208|002|Z|does NOT have all possible information about this product. This||
2208|003|Z|information does not assure that this product is safe, effective,||
2208|004|Z|or appropriate for you. This information is not individual||
2208|005|Z|medical advice and does not substitute for the advice of your||
2208|006|Z|health care professional. Always ask your health care||
2208|007|Z|professional for complete information about this product and your||
2208|008|Z|specific health needs.||
2208|009|B|||
2208|010|T|LEVONORGESTREL-RELEASING 8 YEAR SYSTEM - INTRAUTERINE||
2208|011|F|(LEE-voe-nor-JES-trel)||
2208|012|B|||
2208|013|C|COMMON BRAND NAME(S): Liletta, Mirena||
2208|014|B|||
2208|015|U|USES:  This product is a small, flexible device that is placed in||
2208|016|U|the womb (uterus) to prevent pregnancy. It is used by women who||
2208|017|U|want to use a reversible birth control method that works for a||
2208|018|U|long time (up to 8 years). It is also used to treat heavy||
2208|019|U|menstrual bleeding in women who choose to use this birth control||
2208|020|U|method. The device slowly releases a hormone (levonorgestrel)||
2208|021|U|that is similar to a hormone that women normally make. This||
2208|022|U|device and hormone helps prevent pregnancy.||
2208|023|U|   This product does not protect against sexually transmitted||
2208|024|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
2208|025|U|an effective barrier method (latex or polyurethane condom/dental||
2208|026|U|dams) during sexual activity will help to decrease your risk of||
2208|027|U|infection.||
2208|028|B|||
2208|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2208|030|H|from your pharmacist before you start using this product. If you||
2208|031|H|have any questions, ask your doctor or pharmacist.||
2208|032|H|   This device is placed in your uterus by a health care provider||
2208|033|H|during an in-office visit. It is left in place for up to 8 years.||
2208|034|H|Schedule a follow-up visit 4 to 6 weeks after the device is||
2208|035|H|placed to make sure it is still in the proper position.||
2208|036|H|   Ask your doctor if you need to use a backup form of birth||
2208|037|H|control for the first 7 days after this device is placed, to||
2208|038|H|prevent pregnancy until the device has enough time to work.||
2208|039|H|   This device may sometimes move out of place or come out by||
2208|040|H|itself. After each menstrual period, check to make sure it is in||
2208|041|H|the proper position. Learn how to carefully check the position of||
2208|042|H|this device from the Patient Information Leaflet and/or your||
2208|043|H|health care provider. If it comes out or if you cannot feel the||
2208|044|H|threads, contact your doctor promptly and use a backup form of||
2208|045|H|non-hormonal birth control (such as condoms, spermicide) to||
2208|046|H|prevent pregnancy until otherwise directed by your doctor.||
2208|047|H|   If you wish to continue this method of birth control, the used||
2208|048|H|device may be removed and replaced with a new one after 8 years||
2208|049|H|to prevent pregnancy or after 5 years to treat heavy menstrual||
2208|050|H|bleeding. Either way, the used device should be removed after 8||
2208|051|H|years. Your health care provider can remove this device whenever||
2208|052|H|you want to stop using this method of birth control.||
2208|053|B|||
2208|054|S|SIDE EFFECTS:  Pain, bleeding, or dizziness during and after||
2208|055|S|placement of the device may occur. Cramps, irregular menstrual||
2208|056|S|periods, and vaginal bleeding between periods (spotting) may||
2208|057|S|occur, especially during the first few weeks of use. Headache,||
2208|058|S|nausea, breast tenderness, or weight gain may also occur. If any||
2208|059|S|of these effects last or get worse, tell your doctor promptly.||
2208|060|S|   After your body adjusts to this product, it is normal to have||
2208|061|S|fewer bleeding days during your menstrual periods, and some women||
2208|062|S|stop having periods altogether. This will not affect your ability||
2208|063|S|to become pregnant after stopping use of this product.||
2208|064|S|   Remember that this medication device has been prescribed||
2208|065|S|because your doctor has judged that the benefit to you is greater||
2208|066|S|than the risk of side effects. Many people using this device do||
2208|067|S|not have serious side effects.||
2208|068|S|   Tell your doctor right away if you have any serious side||
2208|069|S|effects, including: stomach/abdominal pain, vomiting, lumps in||
2208|070|S|the breast, mental/mood changes (such as new/worsening||
2208|071|S|depression), unusual changes in vaginal bleeding (such as||
2208|072|S|continuous spotting, sudden heavy bleeding, missed periods), dark||
2208|073|S|urine, yellowing eyes/skin, unusual headaches (including||
2208|074|S|headaches with vision changes/lack of coordination, worsening of||
2208|075|S|migraines, sudden/very severe headaches).||
2208|076|S|   Using an intrauterine device (IUD) may increase your risk for||
2208|077|S|a rare but serious pelvic infection (pelvic inflammatory||
2208|078|S|disease-PID), which can cause permanent damage to sex organs and||
2208|079|S|infertility. The risk is greater in women who have multiple||
2208|080|S|sexual partners, or who are infected with a sexually transmitted||
2208|081|S|disease (STD), or who have had PID in the past (see also||
2208|082|S|Precautions section). Tell your doctor right away if you||
2208|083|S|experience symptoms of PID, including: unexplained fever/chills,||
2208|084|S|lower abdominal/pelvic pain, pain during sexual intercourse,||
2208|085|S|genital sores, unusual vaginal discharge.||
2208|086|S|   A very serious allergic reaction to this drug is rare.||
2208|087|S|However, get medical help right away if you notice any symptoms||
2208|088|S|of a serious allergic reaction, including: rash, itching/swelling||
2208|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2208|090|S|breathing.||
2208|091|S|   This is not a complete list of possible side effects. If you||
2208|092|S|notice other effects not listed above, contact your doctor or||
2208|093|S|pharmacist.||
2208|094|S|   In the US -||
2208|095|S|   Call your doctor for medical advice about side effects. You||
2208|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2208|097|S|www.fda.gov/medwatch.||
2208|098|S|   In Canada - Call your doctor for medical advice about side||
2208|099|S|effects. You may report side effects to Health Canada at||
2208|100|S|1-866-234-2345.||
2208|101|B|||
2208|102|P|PRECAUTIONS:  Before using this medication device, tell your||
2208|103|P|doctor or pharmacist if you are allergic to levonorgestrel, or to||
2208|104|P|any other progestins (such as norethindrone, desogestrel); or if||
2208|105|P|you have any other allergies. This product may contain inactive||
2208|106|P|ingredients, which can cause allergic reactions or other||
2208|107|P|problems. Talk to your pharmacist for more details.||
2208|108|P|   Before using this product, tell your doctor or pharmacist your||
2208|109|P|medical history, especially of: recent pregnancy, current||
2208|110|P|breastfeeding, bleeding/blood disorders, high blood pressure,||
2208|111|P|abnormal breast exam, cancer (especially endometrial or breast||
2208|112|P|cancer), depression, diabetes, severe headaches/migraines, heart||
2208|113|P|problems (such as heart valve disease, irregular heartbeat,||
2208|114|P|previous heart attack), liver disease (including tumors),||
2208|115|P|previous pregnancy outside the uterus (ectopic pregnancy),||
2208|116|P|stroke, unexplained vaginal bleeding, uterus problems (such as||
2208|117|P|fibroids, pelvic inflammatory disease-PID), conditions that||
2208|118|P|weaken the immune system/increase the risk of infection (such as||
2208|119|P|HIV, leukemia, IV drug abuse).||
2208|120|P|   If you or partner have other sexual partners, this device may||
2208|121|P|not be the best birth control method for you. If you or your||
2208|122|P|partner get a sexually transmitted disease (including HIV,||
2208|123|P|gonorrhea, chlamydia), contact your doctor right away. Ask your||
2208|124|P|doctor if you should continue to use this device for birth||
2208|125|P|control.||
2208|126|P|   Before having surgery, tell your doctor or dentist about all||
2208|127|P|the products you use (including prescription drugs,||
2208|128|P|nonprescription drugs, and herbal products). Also, if you are||
2208|129|P|going to have an MRI test, tell testing personnel that you are||
2208|130|P|using this device. They may need to adjust your MRI test.||
2208|131|P|   This device should not be used during pregnancy. If you become||
2208|132|P|pregnant or think you may be pregnant, tell your doctor right||
2208|133|P|away.||
2208|134|P|   Levonorgestrel passes into breast milk. Consult your doctor||
2208|135|P|before breastfeeding.||
2208|136|B|||
2208|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2208|138|I|medications work or increase your risk for serious side effects.||
2208|139|I|This document does not contain all possible drug interactions.||
2208|140|I|Keep a list of all the products you use (including||
2208|141|I|prescription/nonprescription drugs and herbal products) and share||
2208|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
2208|143|I|the dosage of any medicines without your doctor's approval.||
2208|144|B|||
2208|145|O|OVERDOSE:  This medication device may be harmful if swallowed. If||
2208|146|O|someone has swallowed it and has serious symptoms such as passing||
2208|147|O|out or trouble breathing, call 911. Otherwise, call a poison||
2208|148|O|control center right away. US residents can call 1-800-222-1222.||
2208|149|O|Canada residents can call 1-844-764-7669.||
2208|150|B|||
2208|151|N|NOTES:  You should have regular complete physical exams including||
2208|152|N|blood pressure, breast exam, pelvic exam, and screening for||
2208|153|N|cervical cancer (Pap smear). Follow your doctor's instructions||
2208|154|N|for examining your breasts, and report any lumps right away. Keep||
2208|155|N|all medical and lab appointments. Consult your doctor for more||
2208|156|N|details.||
2208|157|B|||
2208|158|D|MISSED DOSE:  Not applicable.||
2208|159|B|||
2208|160|R|STORAGE:  Before use, store at room temperature. Keep all||
2208|161|R|medications and medical devices away from children and pets.||
2208|162|R|   Do not flush medications down the toilet or pour them into a||
2208|163|R|drain unless instructed to do so. Properly discard this product||
2208|164|R|when it is expired or no longer needed. Consult your pharmacist||
2208|165|R|or local waste disposal company.||
2208|166|B|||
2208|167|A|Information last revised October 2025.||
2208|168|A|Copyright(c) 2025 First Databank, Inc.||
2208|169|B|||
2209|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2209|002|Z|does NOT have all possible information about this product. This||
2209|003|Z|information does not assure that this product is safe, effective,||
2209|004|Z|or appropriate for you. This information is not individual||
2209|005|Z|medical advice and does not substitute for the advice of your||
2209|006|Z|health care professional. Always ask your health care||
2209|007|Z|professional for complete information about this product and your||
2209|008|Z|specific health needs.||
2209|009|B|||
2209|010|T|SACITUZUMAB GOVITECAN - INJECTION||
2209|011|F|(SAK-i-TOOZ-ue-mab GOE-vi-TEE-kan)||
2209|012|B|||
2209|013|C|COMMON BRAND NAME(S): Trodelvy||
2209|014|B|||
2209|015|W|WARNING:  This medication may cause a very serious low white||
2209|016|W|blood cell count, which may lower your ability to fight||
2209|017|W|infections. This may make you more likely to get a serious||
2209|018|W|(rarely fatal) infection or make any infection you have worse. If||
2209|019|W|you are at a higher risk of having a lower white blood cell||
2209|020|W|count, your doctor may prescribe another medication to help||
2209|021|W|prevent it. Tell your doctor right away if you have any signs of||
2209|022|W|infection (such as sore throat that doesn't go away, fever,||
2209|023|W|chills).||
2209|024|W|   Severe diarrhea may occur. To prevent a serious loss of body||
2209|025|W|water (dehydration), drink plenty of fluids. Tell your doctor||
2209|026|W|right away if you have diarrhea. Your doctor may prescribe||
2209|027|W|antidiarrheal medication to take during treatment with this||
2209|028|W|medication.||
2209|029|B|||
2209|030|U|USES:  This medication is used to treat certain types of breast||
2209|031|U|cancer. It works by slowing or stopping the growth of cancer||
2209|032|U|cells.||
2209|033|B|||
2209|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2209|035|H|from your pharmacist before you start using sacituzumab govitecan||
2209|036|H|and each time you get a refill. If you have any questions, ask||
2209|037|H|your doctor or pharmacist.||
2209|038|H|   This medication is given by injection into a vein by a health||
2209|039|H|care professional. It is given as directed by your doctor,||
2209|040|H|usually on days 1 and 8 of every treatment cycle. Each treatment||
2209|041|H|cycle is 21 days. The first dose is usually injected slowly over||
2209|042|H|3 hours, and you will be monitored for at least 30 minutes after||
2209|043|H|each injection. If you can take the first dose well, later doses||
2209|044|H|may be given over 1 to 2 hours.||
2209|045|H|   The dosage is based on your medical condition, weight, and||
2209|046|H|response to treatment.||
2209|047|H|   Infusion reactions may happen during the infusion of this drug||
2209|048|H|and for 24 hours afterward. Your doctor may prescribe other||
2209|049|H|medications before each treatment to help prevent these side||
2209|050|H|effects. Tell your doctor right away if you have any symptoms of||
2209|051|H|infusion reactions such as fever, chills, flushing, dizziness, or||
2209|052|H|shortness of breath. Your doctor may slow down or stop your||
2209|053|H|treatment for some time.||
2209|054|H|   Your doctor should prescribe medications before each dose to||
2209|055|H|help prevent side effects such as infusion reactions, nausea, and||
2209|056|H|vomiting.||
2209|057|H|   Use this medication regularly to get the most benefit from it.||
2209|058|H|To help you remember, mark your calendar with a reminder.||
2209|059|B|||
2209|060|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2209|061|S|   Numbness/tingling in your hands/feet, tiredness, trouble||
2209|062|S|sleeping, loss of appetite, change in how food tastes,||
2209|063|S|constipation, headache, dizziness, muscle/joint pain, or||
2209|064|S|dry/itchy skin may occur. If any of these effects last or get||
2209|065|S|worse, tell your doctor or pharmacist promptly.||
2209|066|S|   Pain or sores in the mouth and throat may occur. Brush your||
2209|067|S|teeth carefully/gently, avoid using mouthwash that contains||
2209|068|S|alcohol, and rinse your mouth often with cool water mixed with||
2209|069|S|baking soda or salt. It may also be best to eat soft, moist||
2209|070|S|foods.||
2209|071|S|   Nausea and vomiting are common and can sometimes be severe.||
2209|072|S|Nausea, vomiting, or diarrhea that doesn't stop may result in||
2209|073|S|dehydration. Your doctor may prescribe medication to prevent or||
2209|074|S|relieve nausea, vomiting, and diarrhea. Eating several small||
2209|075|S|meals, not eating before treatment, or limiting activity may help||
2209|076|S|lessen some of these effects. Contact your doctor right away if||
2209|077|S|you are not able to get your diarrhea under control within 24||
2209|078|S|hours, or if you notice any symptoms of dehydration, such as||
2209|079|S|unusual decreased urination, unusual dry mouth/thirst, fast||
2209|080|S|heartbeat, or dizziness/lightheadedness.||
2209|081|S|   Temporary hair loss may occur. Normal hair growth should||
2209|082|S|return after treatment has ended.||
2209|083|S|   People using this medication may have serious side effects.||
2209|084|S|However, you have been prescribed this drug because your doctor||
2209|085|S|has judged that the benefit to you is greater than the risk of||
2209|086|S|side effects. Careful monitoring by your doctor may decrease your||
2209|087|S|risk.||
2209|088|S|   Tell your doctor right away if you have any serious side||
2209|089|S|effects, including: easy bruising/bleeding, black/bloody stools.||
2209|090|S|   Sacituzumab govitecan can commonly cause a rash that is||
2209|091|S|usually not serious. However, you may not be able to tell it||
2209|092|S|apart from a rare rash that could be a sign of a severe reaction.||
2209|093|S|Get medical help right away if you develop any rash.||
2209|094|S|   A very serious allergic reaction to this drug is rare.||
2209|095|S|However, get medical help right away if you notice any symptoms||
2209|096|S|of a serious allergic reaction, including: rash, itching/swelling||
2209|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2209|098|S|breathing.||
2209|099|S|   This is not a complete list of possible side effects. If you||
2209|100|S|notice other effects not listed above, contact your doctor or||
2209|101|S|pharmacist.||
2209|102|S|   In the US -||
2209|103|S|   Call your doctor for medical advice about side effects. You||
2209|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2209|105|S|www.fda.gov/medwatch.||
2209|106|S|   In Canada - Call your doctor for medical advice about side||
2209|107|S|effects. You may report side effects to Health Canada at||
2209|108|S|1-866-234-2345.||
2209|109|B|||
2209|110|P|PRECAUTIONS:  Before receiving sacituzumab govitecan, tell your||
2209|111|P|doctor or pharmacist if you are allergic to it; or if you have||
2209|112|P|any other allergies. This product may contain inactive||
2209|113|P|ingredients, which can cause allergic reactions or other||
2209|114|P|problems. Talk to your pharmacist for more details.||
2209|115|P|   Before using this medication, tell your doctor or pharmacist||
2209|116|P|your medical history, especially of: liver problems, nerve||
2209|117|P|problems (such as numbness/tingling).||
2209|118|P|   Sacituzumab govitecan can make you more likely to get||
2209|119|P|infections or may make current infections worse. Stay away from||
2209|120|P|anyone who has an infection that may easily spread (such as||
2209|121|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
2209|122|P|have been exposed to an infection or for more details.||
2209|123|P|   Tell your health care professional that you are using||
2209|124|P|sacituzumab govitecan before having any||
2209|125|P|immunizations/vaccinations. Avoid contact with people who have||
2209|126|P|recently received live vaccines (such as flu vaccine inhaled||
2209|127|P|through the nose).||
2209|128|P|   To lower the chance of getting cut, bruised, or injured, use||
2209|129|P|caution with sharp objects like razors and nail cutters, and||
2209|130|P|avoid activities such as contact sports.||
2209|131|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2209|132|P|can make you more dizzy. Do not drive, use machinery, or do||
2209|133|P|anything that needs alertness or clear vision until you can do it||
2209|134|P|safely. Limit alcoholic beverages. Talk to your doctor if you are||
2209|135|P|using marijuana (cannabis).||
2209|136|P|   If you have been told that you carry a certain gene (uridine||
2209|137|P|diphosphate-glucuronosyl transferase A1), you may have a higher||
2209|138|P|risk of side effects with this medication, especially low white||
2209|139|P|blood cell counts. Ask your doctor for details.||
2209|140|P|   Before having surgery, tell your doctor or dentist about all||
2209|141|P|the products you use (including prescription drugs,||
2209|142|P|nonprescription drugs, and herbal products).||
2209|143|P|   Older adults may be at greater risk for infections while using||
2209|144|P|this drug.||
2209|145|P|   Tell your doctor if you are pregnant or plan to become||
2209|146|P|pregnant. You should not become pregnant while using sacituzumab||
2209|147|P|govitecan. Sacituzumab govitecan may harm an unborn baby. Your||
2209|148|P|doctor should order a pregnancy test before you start this||
2209|149|P|medication. Women using this medication should ask about reliable||
2209|150|P|forms of birth control during treatment and for 6 months after||
2209|151|P|the last dose. Men using this medication should ask about||
2209|152|P|reliable forms of birth control during treatment and for 3 months||
2209|153|P|after the last dose. If you or your partner becomes pregnant,||
2209|154|P|talk to your doctor right away about the risks and benefits of||
2209|155|P|this medication.||
2209|156|P|   It is unknown if this drug passes into breast milk. Because of||
2209|157|P|the possible risk to the infant, breastfeeding is not recommended||
2209|158|P|while using this drug and for 1 month after the last dose.||
2209|159|P|Consult your doctor before breastfeeding.||
2209|160|B|||
2209|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2209|162|I|medications work or increase your risk for serious side effects.||
2209|163|I|This document does not contain all possible drug interactions.||
2209|164|I|Keep a list of all the products you use (including||
2209|165|I|prescription/nonprescription drugs and herbal products) and share||
2209|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
2209|167|I|the dosage of any medicines without your doctor's approval.||
2209|168|B|||
2209|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2209|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2209|171|O|poison control center right away. US residents can call||
2209|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2209|173|B|||
2209|174|N|NOTES:  Do not share this medication with others.||
2209|175|N|   Lab and/or medical tests (such as complete blood counts)||
2209|176|N|should be done while you are using this medication. Keep all||
2209|177|N|medical and lab appointments.||
2209|178|B|||
2209|179|D|MISSED DOSE:  It is important to get each dose of this medication||
2209|180|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2209|181|D|right away for a new dosing schedule.||
2209|182|B|||
2209|183|R|STORAGE:  Not applicable. This medication is given in a hospital||
2209|184|R|or clinic or doctor's office and will not be stored at home.||
2209|185|B|||
2209|186|M|MEDICAL ALERT:  Your condition can cause complications in a||
2209|187|M|medical emergency. For information about enrolling in MedicAlert,||
2209|188|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2209|189|B|||
2209|190|A|Information last revised April 2025.||
2209|191|A|Copyright(c) 2025 First Databank, Inc.||
2209|192|B|||
2210|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2210|002|Z|does NOT have all possible information about this product. This||
2210|003|Z|information does not assure that this product is safe, effective,||
2210|004|Z|or appropriate for you. This information is not individual||
2210|005|Z|medical advice and does not substitute for the advice of your||
2210|006|Z|health care professional. Always ask your health care||
2210|007|Z|professional for complete information about this product and your||
2210|008|Z|specific health needs.||
2210|009|B|||
2210|010|T|MITOMYCIN - URETHRAL||
2210|011|F|(MYE-toe-MYE-sin)||
2210|012|B|||
2210|013|C|COMMON BRAND NAME(S): Jelmyto||
2210|014|B|||
2210|015|U|USES:  Mitomycin is used to treat cancer in the lining of the||
2210|016|U|urinary tract and kidneys. It works by slowing or stopping the||
2210|017|U|growth of cancer cells.||
2210|018|B|||
2210|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2210|020|H|from your pharmacist before you start using mitomycin and each||
2210|021|H|time you get a refill. If you have any questions, ask your doctor||
2210|022|H|or pharmacist.||
2210|023|H|   This medication is given into the kidney through a tube||
2210|024|H|(catheter) by a health care professional as directed by your||
2210|025|H|doctor. This medication is usually given weekly for the first 6||
2210|026|H|weeks and then less often as directed by your doctor.||
2210|027|H|   Since this drug can be absorbed through the skin and may harm||
2210|028|H|you, be careful to avoid contact with your urine for at least 6||
2210|029|H|hours after each treatment. To avoid splashing, sit down on the||
2210|030|H|toilet seat each time you urinate during the 6-hour period after||
2210|031|H|treatment. When you are done, flush the toilet several times.||
2210|032|H|Afterward, wash your hands, your inner thighs, and genital area||
2210|033|H|well with soap and water. If any urine comes into contact with||
2210|034|H|your clothing, the clothing should be washed right away and||
2210|035|H|separately from your other clothing.||
2210|036|B|||
2210|037|S|SIDE EFFECTS:  Nausea, vomiting, or stomach/abdominal pain may||
2210|038|S|occur. This medication usually will cause your urine to turn a||
2210|039|S|violet to blue color. This is a normal, harmless effect of the||
2210|040|S|drug. If any of these effects last or get worse, tell your doctor||
2210|041|S|or pharmacist promptly.||
2210|042|S|   People using this medication may have serious side effects.||
2210|043|S|However, you have been prescribed this drug because your doctor||
2210|044|S|has judged that the benefit to you is greater than the risk of||
2210|045|S|side effects. Careful monitoring by your doctor may decrease your||
2210|046|S|risk.||
2210|047|S|   Tell your doctor right away if you have any serious side||
2210|048|S|effects, including: signs of kidney problems (such as change in||
2210|049|S|the amount of urine), low back/side pain (flank pain), signs of||
2210|050|S|infection (such as sore throat that doesn't go away, fever,||
2210|051|S|chills), easy bruising/bleeding.||
2210|052|S|   A very serious allergic reaction to this drug is rare.||
2210|053|S|However, get medical help right away if you notice any symptoms||
2210|054|S|of a serious allergic reaction, including: rash, itching/swelling||
2210|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2210|056|S|breathing.||
2210|057|S|   This is not a complete list of possible side effects. If you||
2210|058|S|notice other effects not listed above, contact your doctor or||
2210|059|S|pharmacist.||
2210|060|S|   In the US -||
2210|061|S|   Call your doctor for medical advice about side effects. You||
2210|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2210|063|S|www.fda.gov/medwatch.||
2210|064|S|   In Canada - Call your doctor for medical advice about side||
2210|065|S|effects. You may report side effects to Health Canada at||
2210|066|S|1-866-234-2345.||
2210|067|B|||
2210|068|P|PRECAUTIONS:  Before using mitomycin, tell your doctor or||
2210|069|P|pharmacist if you are allergic to it; or if you have any other||
2210|070|P|allergies. This product may contain inactive ingredients, which||
2210|071|P|can cause allergic reactions or other problems. Talk to your||
2210|072|P|pharmacist for more details.||
2210|073|P|   Before using this medication, tell your doctor or pharmacist||
2210|074|P|your medical history, especially of: a hole in the bladder or||
2210|075|P|urinary tract (perforation).||
2210|076|P|   Before having surgery, tell your doctor or dentist about all||
2210|077|P|the products you use (including prescription drugs,||
2210|078|P|nonprescription drugs, and herbal products).||
2210|079|P|   Tell your doctor if you are pregnant or plan to become||
2210|080|P|pregnant. You should not become pregnant while using mitomycin.||
2210|081|P|Mitomycin may harm an unborn baby. Women using this medication||
2210|082|P|should ask about reliable forms of birth control during treatment||
2210|083|P|and for 6 months after the last dose. Men using this medication||
2210|084|P|should ask about reliable forms of birth control during treatment||
2210|085|P|and for 3 months after the last dose. If you or your partner||
2210|086|P|becomes pregnant, talk to your doctor right away about the risks||
2210|087|P|and benefits of this medication.||
2210|088|P|   It is unknown if this drug passes into breast milk. Because of||
2210|089|P|the possible risk to the infant, breastfeeding is not recommended||
2210|090|P|while using this drug and for 1 week after the last dose. Consult||
2210|091|P|your doctor before breastfeeding.||
2210|092|B|||
2210|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2210|094|I|medications work or increase your risk for serious side effects.||
2210|095|I|This document does not contain all possible drug interactions.||
2210|096|I|Keep a list of all the products you use (including||
2210|097|I|prescription/nonprescription drugs and herbal products) and share||
2210|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
2210|099|I|the dosage of any medicines without your doctor's approval.||
2210|100|B|||
2210|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2210|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2210|103|O|poison control center right away. US residents can call||
2210|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2210|105|B|||
2210|106|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2210|107|N|kidney function) should be done before you start using this||
2210|108|N|medication and while you are using it. Keep all medical and lab||
2210|109|N|appointments. Consult your doctor for more details.||
2210|110|B|||
2210|111|D|MISSED DOSE:  It is important to get each dose of this medication||
2210|112|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2210|113|D|right away for a new dosing schedule.||
2210|114|B|||
2210|115|R|STORAGE:  Not applicable. This medication is given in a hospital||
2210|116|R|or clinic and will not be stored at home.||
2210|117|B|||
2210|118|M|MEDICAL ALERT:  Your condition can cause complications in a||
2210|119|M|medical emergency. For information about enrolling in MedicAlert,||
2210|120|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2210|121|B|||
2210|122|A|Information last revised April 2025.||
2210|123|A|Copyright(c) 2025 First Databank, Inc.||
2210|124|B|||
2211|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2211|002|Z|does NOT have all possible information about this product. This||
2211|003|Z|information does not assure that this product is safe, effective,||
2211|004|Z|or appropriate for you. This information is not individual||
2211|005|Z|medical advice and does not substitute for the advice of your||
2211|006|Z|health care professional. Always ask your health care||
2211|007|Z|professional for complete information about this product and your||
2211|008|Z|specific health needs.||
2211|009|B|||
2211|010|T|ADUCANUMAB - INJECTION||
2211|011|F|(A-due-KAN-ue-mab)||
2211|012|B|||
2211|013|C|COMMON BRAND NAME(S): Aduhelm||
2211|014|B|||
2211|015|W|WARNING:  This medication may increase your risk of serious||
2211|016|W|(possibly fatal) side effects such as temporary swelling of the||
2211|017|W|brain, or small spots of bleeding in or on the surface of the||
2211|018|W|brain. These side effects are also known as amyloid-related||
2211|019|W|imaging abnormalities (ARIA). Your doctor may order a genetic||
2211|020|W|test to measure your risk for ARIA before you start this||
2211|021|W|medication. If the genetic test shows you are at greater risk,||
2211|022|W|your doctor should discuss with you the risks and benefits of||
2211|023|W|starting aducanumab. Your doctor will do magnetic resonance||
2211|024|W|imaging (MRI) scans before and during treatment to check for||
2211|025|W|these side effects. If you are also taking medications that can||
2211|026|W|cause bleeding/bruising (including antiplatelet drugs such as||
2211|027|W|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
2211|028|W|such as warfarin/dabigatran), your doctor will monitor you more||
2211|029|W|closely for bleeding. ARIA usually go away over time. They do not||
2211|030|W|always cause symptoms, but tell your doctor right away if you||
2211|031|W|develop symptoms such as headache, dizziness, nausea, confusion,||
2211|032|W|seizures, trouble walking, or vision changes.||
2211|033|B|||
2211|034|U|USES:  This medication is used to treat Alzheimer's disease. It||
2211|035|U|is thought to work by decreasing a certain substance (amyloid||
2211|036|U|beta) that builds up in the brain of people with Alzheimer's||
2211|037|U|disease. Aducanumab belongs to a class of drugs known as||
2211|038|U|monoclonal antibodies. This medication is not a cure for||
2211|039|U|Alzheimer's disease. It may help slow down worsening of this||
2211|040|U|disease and may delay disability.||
2211|041|B|||
2211|042|H|HOW TO USE:  Read the Medication Guide provided by your||
2211|043|H|pharmacist before you start using aducanumab and each time you||
2211|044|H|receive an injection. If you have any questions, ask your doctor||
2211|045|H|or pharmacist.||
2211|046|H|   This medication is given by injection into a vein as directed||
2211|047|H|by your doctor, usually every 4 weeks. The injection is given by||
2211|048|H|a health care professional, usually over 1 hour. The dosage is||
2211|049|H|based on your medical condition, weight, and response to||
2211|050|H|treatment. To reduce your risk of side effects, your doctor may||
2211|051|H|start this medication at a low dose and gradually increase your||
2211|052|H|dose.||
2211|053|H|   Use this medication regularly to get the most benefit from it.||
2211|054|H|To help you remember, mark your calendar with a reminder.||
2211|055|B|||
2211|056|S|SIDE EFFECTS:  See also Warning section.||
2211|057|S|   Remember that this medication has been prescribed because your||
2211|058|S|doctor has judged that the benefit to you is greater than the||
2211|059|S|risk of side effects. Many people using this medication do not||
2211|060|S|have serious side effects.||
2211|061|S|   A very serious allergic reaction to this drug is rare.||
2211|062|S|However, get medical help right away if you notice any symptoms||
2211|063|S|of a serious allergic reaction, including: rash, itching/swelling||
2211|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2211|065|S|breathing.||
2211|066|S|   This is not a complete list of possible side effects. If you||
2211|067|S|notice other effects not listed above, contact your doctor or||
2211|068|S|pharmacist.||
2211|069|S|   In the US -||
2211|070|S|   Call your doctor for medical advice about side effects. You||
2211|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2211|072|S|www.fda.gov/medwatch.||
2211|073|S|   In Canada - Call your doctor for medical advice about side||
2211|074|S|effects. You may report side effects to Health Canada at||
2211|075|S|1-866-234-2345.||
2211|076|B|||
2211|077|P|PRECAUTIONS:  Before using aducanumab, tell your doctor or||
2211|078|P|pharmacist if you are allergic to it; or if you have any other||
2211|079|P|allergies. This product may contain inactive ingredients, which||
2211|080|P|can cause allergic reactions or other problems. Talk to your||
2211|081|P|pharmacist for more details.||
2211|082|P|   Before using this medication, tell your doctor or pharmacist||
2211|083|P|your medical history.||
2211|084|P|   Before having surgery, tell your doctor or dentist about all||
2211|085|P|the products you use (including prescription drugs,||
2211|086|P|nonprescription drugs, and herbal products).||
2211|087|P|   During pregnancy, this medication should be used only when||
2211|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
2211|089|P|   It is unknown if this medication passes into breast milk.||
2211|090|P|Consult your doctor before breastfeeding.||
2211|091|B|||
2211|092|I|DRUG INTERACTIONS:  See also Warning section.||
2211|093|I|   Drug interactions may change how your medications work or||
2211|094|I|increase your risk for serious side effects. This document does||
2211|095|I|not contain all possible drug interactions. Keep a list of all||
2211|096|I|the products you use (including prescription/nonprescription||
2211|097|I|drugs and herbal products) and share it with your doctor and||
2211|098|I|pharmacist. Do not start, stop, or change the dosage of any||
2211|099|I|medicines without your doctor's approval.||
2211|100|B|||
2211|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2211|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2211|103|O|poison control center right away. US residents can call||
2211|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2211|105|B|||
2211|106|N|NOTES:  Lab and/or medical tests (such as genetic testing, MRI||
2211|107|N|scans, cognitive assessment) should be done before you start||
2211|108|N|using this medication and while you are using it. Keep all||
2211|109|N|medical and lab appointments.||
2211|110|B|||
2211|111|D|MISSED DOSE:  It is important to get each dose of this medication||
2211|112|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2211|113|D|right away for a new dosing schedule.||
2211|114|B|||
2211|115|R|STORAGE:  Not applicable. This medication is given in a hospital||
2211|116|R|or clinic and will not be stored at home.||
2211|117|B|||
2211|118|A|Information last revised October 2024.||
2211|119|A|Copyright(c) 2025 First Databank, Inc.||
2211|120|B|||
2213|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2213|002|Z|does NOT have all possible information about this product. This||
2213|003|Z|information does not assure that this product is safe, effective,||
2213|004|Z|or appropriate for you. This information is not individual||
2213|005|Z|medical advice and does not substitute for the advice of your||
2213|006|Z|health care professional. Always ask your health care||
2213|007|Z|professional for complete information about this product and your||
2213|008|Z|specific health needs.||
2213|009|B|||
2213|010|T|LEUPROLIDE 6 MONTH PEDIATRIC - SUBCUTANEOUS INJECTION||
2213|011|F|(LOO-proe-lide)||
2213|012|B|||
2213|013|C|COMMON BRAND NAME(S): Fensolvi||
2213|014|B|||
2213|015|U|USES:  Leuprolide is used to stop early puberty (precocious||
2213|016|U|puberty) in children. It helps to delay sexual development (such||
2213|017|U|as growth of the breasts/testicles) and the start of menstrual||
2213|018|U|periods. It also helps slow down early bone growth to increase||
2213|019|U|the likelihood of reaching normal adult height. Leuprolide works||
2213|020|U|by decreasing the amount of sex hormones that a child's body||
2213|021|U|makes (estrogen in girls, testosterone in boys).||
2213|022|B|||
2213|023|V|OTHER USES:  This section contains uses of this drug that are not||
2213|024|V|listed in the approved professional labeling for the drug but||
2213|025|V|that may be prescribed by your health care professional. Use this||
2213|026|V|drug for a condition that is listed in this section only if it||
2213|027|V|has been so prescribed by your health care professional.||
2213|028|V|   This drug may also be used for gender dysphoria or disorders||
2213|029|V|of the uterus (including endometriosis, fibroids).||
2213|030|B|||
2213|031|H|HOW TO USE:  Read the Medication Guide provided by your||
2213|032|H|pharmacist before you start using leuprolide and each time you||
2213|033|H|get a refill. If you have any questions, ask your doctor or||
2213|034|H|pharmacist.||
2213|035|H|   This medication is given by injection under the skin by a||
2213|036|H|health care professional as directed by the doctor, usually every||
2213|037|H|6 months. This product slowly releases the medication into the||
2213|038|H|blood over a 6-month period.||
2213|039|H|   Children's dosage is based on weight and response to||
2213|040|H|treatment. The doctor should consider stopping treatment before||
2213|041|H|age 11 for girls and age 12 for boys. Consult the doctor for||
2213|042|H|details.||
2213|043|H|   Use this medication regularly to get the most benefit from it.||
2213|044|H|To help you remember, mark your calendar with a reminder.||
2213|045|H|   During the first few weeks of treatment, hormone levels will||
2213|046|H|actually go up before they go down. This is a normal response to||
2213|047|H|this medication. You may notice worsening symptoms of early||
2213|048|H|puberty (such as menstrual periods) at the start of treatment.||
2213|049|H|However, you should see an improvement in symptoms usually within||
2213|050|H|1 to 2 months. Tell the doctor promptly if new or worsened||
2213|051|H|symptoms develop after starting treatment.||
2213|052|B|||
2213|053|S|SIDE EFFECTS:  Mild pain/irritation at the injection site, hot||
2213|054|S|flashes (flushing), increased sweating, night sweats, headache,||
2213|055|S|breast changes, acne/seborrhea, joint/muscle aches, vaginal||
2213|056|S|discomfort/dryness, vaginal bleeding/discharge, or increased||
2213|057|S|weight may occur. If any of these effects last or get worse, tell||
2213|058|S|the doctor or pharmacist promptly.||
2213|059|S|   When this medication is used regularly, it is expected that||
2213|060|S|the menstrual period will stop or decrease to light||
2213|061|S|bleeding/spotting during the first 2 months. Tell the doctor||
2213|062|S|promptly if regular periods continue after 2 months of treatment||
2213|063|S|with leuprolide.||
2213|064|S|   Remember that this medication has been prescribed because the||
2213|065|S|doctor has judged that the benefit is greater than the risk of||
2213|066|S|side effects. Many people using this medication do not have||
2213|067|S|serious side effects.||
2213|068|S|   Tell your doctor right away if you have any serious side||
2213|069|S|effects, including: mental/mood changes (such as non-stop crying,||
2213|070|S|irritability, mood swings, aggression).||
2213|071|S|   Get medical help right away if you have any very serious side||
2213|072|S|effects, including: seizures.||
2213|073|S|   Children using leuprolide may be at risk for increased||
2213|074|S|pressure around the brain (intracranial hypertension). Get||
2213|075|S|medical help right away if your child has any of these very||
2213|076|S|serious side effects: nausea/vomiting that doesn't stop, headache||
2213|077|S|that is severe or doesn't go away, eye pain, vision changes (such||
2213|078|S|as blurred/double vision, decreased vision), ringing in the ears.||
2213|079|S|   A very serious allergic reaction to this drug is rare.||
2213|080|S|However, get medical help right away if you notice any symptoms||
2213|081|S|of a serious allergic reaction, including: fever, swollen lymph||
2213|082|S|nodes, rash, itching/swelling (especially of the||
2213|083|S|face/tongue/throat), severe dizziness, trouble breathing.||
2213|084|S|   This is not a complete list of possible side effects. If you||
2213|085|S|notice other effects not listed above, contact the doctor or||
2213|086|S|pharmacist.||
2213|087|S|   In the US -||
2213|088|S|   Call your doctor for medical advice about side effects. You||
2213|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2213|090|S|www.fda.gov/medwatch.||
2213|091|S|   In Canada - Call your doctor for medical advice about side||
2213|092|S|effects. You may report side effects to Health Canada at||
2213|093|S|1-866-234-2345.||
2213|094|B|||
2213|095|P|PRECAUTIONS:  Before using leuprolide, tell the doctor or||
2213|096|P|pharmacist if your child is allergic to it; or to similar drugs||
2213|097|P|(such as histrelin, triptorelin); or if your child has any other||
2213|098|P|allergies. This product may contain inactive ingredients, which||
2213|099|P|can cause allergic reactions or other problems. Talk to the||
2213|100|P|pharmacist for more details.||
2213|101|P|   Before using this medication, tell the doctor or pharmacist||
2213|102|P|the child's medical history, especially of: mental/mood problems||
2213|103|P|(such as depression), seizures.||
2213|104|P|   Before having surgery, tell the doctor or dentist about all||
2213|105|P|the products being used (including prescription drugs,||
2213|106|P|nonprescription drugs, and herbal products).||
2213|107|P|   This medication must not be used during pregnancy. It may harm||
2213|108|P|an unborn baby. Consult your doctor for more details and to||
2213|109|P|discuss using reliable forms of non-hormonal birth control (such||
2213|110|P|as condoms, diaphragm with spermicide) while using this||
2213|111|P|medication. If you become pregnant or think you may be pregnant,||
2213|112|P|tell your doctor right away.||
2213|113|P|   It is unknown if leuprolide passes into breast milk. Because||
2213|114|P|of the possible risk to the infant, breastfeeding is not||
2213|115|P|recommended while using this medication. Consult your doctor||
2213|116|P|before breastfeeding.||
2213|117|B|||
2213|118|I|DRUG INTERACTIONS:  Drug interactions may change how medications||
2213|119|I|work or increase the risk for serious side effects. This document||
2213|120|I|does not contain all possible drug interactions. Keep a list of||
2213|121|I|all the products your child uses (including||
2213|122|I|prescription/nonprescription drugs and herbal products) and share||
2213|123|I|it with the doctor and pharmacist. Do not start, stop, or change||
2213|124|I|the dosage of any medicines without the doctor's approval.||
2213|125|I|   This medication may interfere with certain lab tests possibly||
2213|126|I|causing false test results. Make sure lab personnel and all the||
2213|127|I|doctors know your child uses this drug.||
2213|128|B|||
2213|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2213|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2213|131|O|poison control center right away. US residents can call||
2213|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2213|133|B|||
2213|134|N|NOTES:  Do not share this medication with others.||
2213|135|N|   Lab and/or medical tests (such as hormone levels, height||
2213|136|N|measurements, bone tests) should be done while using this||
2213|137|N|medication. Keep all medical and lab appointments. Consult the||
2213|138|N|doctor for more details.||
2213|139|B|||
2213|140|D|MISSED DOSE:  It is important to get each dose of this medication||
2213|141|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
2213|142|D|right away for a new dosing schedule. Do not double the dose to||
2213|143|D|catch up.||
2213|144|B|||
2213|145|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2213|146|R|doctor's office and will not be stored at home.||
2213|147|B|||
2213|148|A|Information last revised October 2024.||
2213|149|A|Copyright(c) 2025 First Databank, Inc.||
2213|150|B|||
2214|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2214|002|Z|does NOT have all possible information about this product. This||
2214|003|Z|information does not assure that this product is safe, effective,||
2214|004|Z|or appropriate for you. This information is not individual||
2214|005|Z|medical advice and does not substitute for the advice of your||
2214|006|Z|health care professional. Always ask your health care||
2214|007|Z|professional for complete information about this product and your||
2214|008|Z|specific health needs.||
2214|009|B|||
2214|010|T|DARATUMUMAB/HYALURONIDASE - SUBCUTANEOUS INJECTION||
2214|011|F|(DAR-a-TOOM-ue-mab/HYE-al-ure-ON-i-dase)||
2214|012|B|||
2214|013|C|COMMON BRAND NAME(S): Darzalex Faspro||
2214|014|B|||
2214|015|U|USES:  This medication is used to treat a certain type of cancer||
2214|016|U|(multiple myeloma). This medication contains 2 ingredients:||
2214|017|U|daratumumab and hyaluronidase. Daratumumab belongs to a class of||
2214|018|U|drugs known as monoclonal antibodies. It works by slowing or||
2214|019|U|stopping the growth of cancer cells. Hyaluronidase is used to||
2214|020|U|help the body absorb daratumumab, which helps it work better.||
2214|021|U|   This medication is also used to treat light chain (AL)||
2214|022|U|amyloidosis.||
2214|023|U|   This monograph is about the following||
2214|024|U|daratumumab/hyaluronidase products: daratumumab/hyaluronidase,||
2214|025|U|daratumumab/hyaluronidase-fihj.||
2214|026|B|||
2214|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2214|028|H|from your pharmacist before you start using||
2214|029|H|daratumumab/hyaluronidase and each time you receive this||
2214|030|H|medication. If you have any questions, ask your doctor or||
2214|031|H|pharmacist.||
2214|032|H|   This medication is given by injection under the skin of your||
2214|033|H|abdomen by a health care professional. The injection is given||
2214|034|H|over about 3 to 5 minutes. It is given as directed by your doctor||
2214|035|H|on a treatment schedule, usually once a week for the first 6 to 9||
2214|036|H|weeks (depending on your medical condition). Afterward, your||
2214|037|H|doctor may direct you to receive this medication less often.||
2214|038|H|Carefully follow your doctor's directions for your treatment||
2214|039|H|schedule.||
2214|040|H|   Serious injection reactions may happen during or soon after||
2214|041|H|the injection of this drug. Your doctor may prescribe other||
2214|042|H|medications before and after each treatment to help prevent these||
2214|043|H|side effects. Get medical help right away if you have any||
2214|044|H|symptoms of injection reactions such as throat tightness, trouble||
2214|045|H|breathing, itchy/runny/stuffy nose, chills, nausea, vomiting,||
2214|046|H|throat irritation, fever, cough, headache, itching, dizziness, or||
2214|047|H|fast heartbeat.||
2214|048|H|   To get the most benefit, do not miss any doses. To help you||
2214|049|H|remember, mark your calendar with a reminder.||
2214|050|B|||
2214|051|S|SIDE EFFECTS:  See also How to Use section.||
2214|052|S|   Tiredness, back pain, joint pain, diarrhea/constipation,||
2214|053|S|trouble sleeping, or loss of appetite may occur. Skin reactions||
2214|054|S|at or near the injection site can happen, sometimes more than 24||
2214|055|S|hours after the injection. Symptoms may include itching,||
2214|056|S|swelling, bruising, or redness of the skin. If any of these||
2214|057|S|effects last or get worse, tell your doctor or pharmacist||
2214|058|S|promptly.||
2214|059|S|   People using this medication may have serious side effects.||
2214|060|S|However, you have been prescribed this drug because your doctor||
2214|061|S|has judged that the benefit to you is greater than the risk of||
2214|062|S|side effects. Careful monitoring by your doctor may decrease your||
2214|063|S|risk.||
2214|064|S|   Tell your doctor right away if you have any serious side||
2214|065|S|effects, including: easy bruising/bleeding,||
2214|066|S|numbness/tingling/pain in the arms or legs, swelling||
2214|067|S|hands/ankles/feet, blurred vision, eye pain.||
2214|068|S|   This medication may lower your ability to fight infections.||
2214|069|S|This may make you more likely to get a serious (rarely fatal)||
2214|070|S|infection or make any infection you have worse. Tell your doctor||
2214|071|S|right away if you have any signs of infection (such as sore||
2214|072|S|throat that doesn't go away, fever, chills).||
2214|073|S|   Serious (possibly fatal) heart problems have occurred in||
2214|074|S|people using this medication to treat amyloidosis. Tell your||
2214|075|S|doctor right away if you have any symptoms of heart problems,||
2214|076|S|including: chest pain, irregular heartbeat, shortness of breath,||
2214|077|S|fainting.||
2214|078|S|   A very serious allergic reaction to this drug is rare.||
2214|079|S|However, get medical help right away if you notice any symptoms||
2214|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2214|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2214|082|S|breathing.||
2214|083|S|   This is not a complete list of possible side effects. If you||
2214|084|S|notice other effects not listed above, contact your doctor or||
2214|085|S|pharmacist.||
2214|086|S|   In the US -||
2214|087|S|   Call your doctor for medical advice about side effects. You||
2214|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2214|089|S|www.fda.gov/medwatch.||
2214|090|S|   In Canada - Call your doctor for medical advice about side||
2214|091|S|effects. You may report side effects to Health Canada at||
2214|092|S|1-866-234-2345.||
2214|093|B|||
2214|094|P|PRECAUTIONS:  Before using daratumumab/hyaluronidase, tell your||
2214|095|P|doctor or pharmacist if you are allergic to daratumumab or||
2214|096|P|hyaluronidase; or to any daratumumab products; or if you have any||
2214|097|P|other allergies. This product may contain inactive ingredients,||
2214|098|P|which can cause allergic reactions or other problems. Talk to||
2214|099|P|your pharmacist for more details.||
2214|100|P|   Before using this medication, tell your doctor or pharmacist||
2214|101|P|your medical history, especially of: breathing problems (such as||
2214|102|P|chronic obstructive pulmonary disease-COPD), liver disease (such||
2214|103|P|as hepatitis B), shingles (herpes zoster).||
2214|104|P|   Daratumumab/hyaluronidase can make you more likely to get||
2214|105|P|infections or may make current infections worse. Stay away from||
2214|106|P|anyone who has an infection that may easily spread (such as||
2214|107|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
2214|108|P|have been exposed to an infection or for more details.||
2214|109|P|   Tell your health care professional that you are using this||
2214|110|P|medication before having any immunizations/vaccinations. Avoid||
2214|111|P|contact with people who have recently received live vaccines||
2214|112|P|(such as flu vaccine inhaled through the nose).||
2214|113|P|   To lower the chance of getting cut, bruised, or injured, use||
2214|114|P|caution with sharp objects like razors and nail cutters, and||
2214|115|P|avoid activities such as contact sports.||
2214|116|P|   Before having surgery, tell your doctor or dentist about all||
2214|117|P|the products you use (including prescription drugs,||
2214|118|P|nonprescription drugs, and herbal products).||
2214|119|P|   Older adults may be at greater risk for infections while using||
2214|120|P|this drug.||
2214|121|P|   Tell your doctor if you are pregnant or plan to become||
2214|122|P|pregnant. You should not become pregnant while using||
2214|123|P|daratumumab/hyaluronidase. Daratumumab/hyaluronidase may harm an||
2214|124|P|unborn baby. Ask about reliable forms of birth control while||
2214|125|P|using this medication and for at least 3 months after the last||
2214|126|P|dose. If you become pregnant, talk to your doctor right away||
2214|127|P|about the risks and benefits of this medication.||
2214|128|P|   It is unknown if this drug passes into breast milk. Consult||
2214|129|P|your doctor before breastfeeding.||
2214|130|B|||
2214|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2214|132|I|medications work or increase your risk for serious side effects.||
2214|133|I|This document does not contain all possible drug interactions.||
2214|134|I|Keep a list of all the products you use (including||
2214|135|I|prescription/nonprescription drugs and herbal products) and share||
2214|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
2214|137|I|the dosage of any medicines without your doctor's approval.||
2214|138|I|   This medication may interfere with certain lab tests (such as||
2214|139|I|Coombs' test), possibly causing false test results. Make sure lab||
2214|140|I|personnel and all your doctors know you use this drug.||
2214|141|B|||
2214|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2214|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2214|144|O|poison control center right away. US residents can call||
2214|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2214|146|B|||
2214|147|N|NOTES:  Do not share this medication with others.||
2214|148|N|   Lab and/or medical tests (such as complete blood count, test||
2214|149|N|for hepatitis B virus) should be done before you start using this||
2214|150|N|medication and while you are using it. Keep all medical and lab||
2214|151|N|appointments.||
2214|152|B|||
2214|153|D|MISSED DOSE:  It is important to get each dose of this medication||
2214|154|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2214|155|D|right away for a new dosing schedule.||
2214|156|B|||
2214|157|R|STORAGE:  Not applicable. This medication is given in a clinic||
2214|158|R|and will not be stored at home.||
2214|159|B|||
2214|160|M|MEDICAL ALERT:  Your condition can cause complications in a||
2214|161|M|medical emergency. For information about enrolling in MedicAlert,||
2214|162|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2214|163|B|||
2214|164|A|Information last revised April 2025.||
2214|165|A|Copyright(c) 2025 First Databank, Inc.||
2214|166|B|||
2215|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2215|002|Z|does NOT have all possible information about this product. This||
2215|003|Z|information does not assure that this product is safe, effective,||
2215|004|Z|or appropriate for you. This information is not individual||
2215|005|Z|medical advice and does not substitute for the advice of your||
2215|006|Z|health care professional. Always ask your health care||
2215|007|Z|professional for complete information about this product and your||
2215|008|Z|specific health needs.||
2215|009|B|||
2215|010|T|LEMBOREXANT - ORAL||
2215|011|F|(LEM-boe-REX-ant)||
2215|012|B|||
2215|013|C|COMMON BRAND NAME(S): Dayvigo||
2215|014|B|||
2215|015|U|USES:  This medication is used to treat a certain sleep problem||
2215|016|U|(insomnia). It may help you fall asleep, and help you stay asleep||
2215|017|U|longer, so you can get a better night's rest. Lemborexant belongs||
2215|018|U|to a class of drugs known as sedative-hypnotics.||
2215|019|U|   If your insomnia continues for longer than 7 to 10 days after||
2215|020|U|starting treatment, talk to your doctor to see if you need other||
2215|021|U|treatment.||
2215|022|B|||
2215|023|H|HOW TO USE:  Read the Medication Guide provided by your||
2215|024|H|pharmacist before you start taking lemborexant and each time you||
2215|025|H|get a refill. If you have any questions, ask your doctor or||
2215|026|H|pharmacist.||
2215|027|H|   Take lemborexant by mouth as directed by your doctor, usually||
2215|028|H|right before you get into bed. This medication can be taken with||
2215|029|H|or without food, but it may take longer to work if you take it||
2215|030|H|with or right after a meal. Do not take this medication with||
2215|031|H|alcohol or with other drugs that help you sleep.||
2215|032|H|   The dosage is based on your medical condition, response to||
2215|033|H|treatment, and other medications you may be taking. Be sure to||
2215|034|H|tell your doctor and pharmacist about all the products you use||
2215|035|H|(including prescription drugs, nonprescription drugs, and herbal||
2215|036|H|products).||
2215|037|H|   Do not take a dose of this drug unless you have time for a||
2215|038|H|full night's sleep of at least 7 hours. If you have to wake up||
2215|039|H|before that, you may have trouble safely doing anything that||
2215|040|H|needs alertness, such as driving or operating machinery. (See||
2215|041|H|also Precautions section.)||
2215|042|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2215|043|H|using this medication unless your doctor or pharmacist says you||
2215|044|H|may do so safely. Grapefruit can increase the chance of side||
2215|045|H|effects with this medicine. Ask your doctor or pharmacist for||
2215|046|H|more details.||
2215|047|H|   Do not increase your dose, take it more often, or use it for||
2215|048|H|longer than prescribed. Your condition will not improve any||
2215|049|H|faster and your risk of side effects will increase.||
2215|050|H|   Though it helps many people, this medication may sometimes||
2215|051|H|cause addiction. This risk may be higher if you have a substance||
2215|052|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2215|053|H|Take this medication exactly as prescribed to lower the risk of||
2215|054|H|addiction. Ask your doctor or pharmacist for more details.||
2215|055|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
2215|056|H|or if it gets worse.||
2215|057|B|||
2215|058|S|SIDE EFFECTS:  Nightmares, unusual dreams, or tiredness may||
2215|059|S|occur. If any of these effects last or get worse, tell your||
2215|060|S|doctor or pharmacist promptly.||
2215|061|S|   Lemborexant may make you sleepy during the day. Tell your||
2215|062|S|doctor if you have daytime drowsiness. Your dose may need to be||
2215|063|S|adjusted.||
2215|064|S|   Remember that this medication has been prescribed because your||
2215|065|S|doctor has judged that the benefit to you is greater than the||
2215|066|S|risk of side effects. Many people using this medication do not||
2215|067|S|have serious side effects.||
2215|068|S|   Tell your doctor right away if you have any serious side||
2215|069|S|effects, including: mental/mood changes (such as depression,||
2215|070|S|hallucinations, thoughts of suicide), temporary weakness in your||
2215|071|S|legs.||
2215|072|S|   This medication may cause sleep paralysis, which is a||
2215|073|S|temporary inability to move or talk (for up to several minutes)||
2215|074|S|while you are going to sleep or waking up.||
2215|075|S|   Rarely, after taking this drug, people have gotten out of bed||
2215|076|S|and driven vehicles while not fully awake ("sleep-driving").||
2215|077|S|People have also sleepwalked, prepared/eaten food, made phone||
2215|078|S|calls, or had sex while not fully awake. Often, these people do||
2215|079|S|not remember these events. This problem can be dangerous to you||
2215|080|S|or to others. If you find out that you have done any of these||
2215|081|S|activities after taking this medication, tell your doctor right||
2215|082|S|away.||
2215|083|S|   A very serious allergic reaction to this drug is rare.||
2215|084|S|However, get medical help right away if you notice any symptoms||
2215|085|S|of a serious allergic reaction, including: rash, itching/swelling||
2215|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2215|087|S|breathing.||
2215|088|S|   This is not a complete list of possible side effects. If you||
2215|089|S|notice other effects not listed above, contact your doctor or||
2215|090|S|pharmacist.||
2215|091|S|   In the US -||
2215|092|S|   Call your doctor for medical advice about side effects. You||
2215|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2215|094|S|www.fda.gov/medwatch.||
2215|095|S|   In Canada - Call your doctor for medical advice about side||
2215|096|S|effects. You may report side effects to Health Canada at||
2215|097|S|1-866-234-2345.||
2215|098|B|||
2215|099|P|PRECAUTIONS:  Before taking lemborexant, tell your doctor or||
2215|100|P|pharmacist if you are allergic to it; or if you have any other||
2215|101|P|allergies. This product may contain inactive ingredients which||
2215|102|P|can cause allergic reactions or other problems. Talk to your||
2215|103|P|pharmacist for more details.||
2215|104|P|   Before using this medication, tell your doctor or pharmacist||
2215|105|P|your medical history, especially of: a certain sleep disorder||
2215|106|P|(narcolepsy), liver disease, lung disease/breathing problems||
2215|107|P|(such as sleep apnea, chronic obstructive pulmonary disease-||
2215|108|P|COPD), mental/mood problems (such as depression, thoughts of||
2215|109|P|suicide), personal or family history of a substance use disorder||
2215|110|P|(such as overuse of or addiction to drugs/alcohol), a certain||
2215|111|P|muscle weakness disorder (cataplexy).||
2215|112|P|   The effects of this drug can last even after you wake up the||
2215|113|P|next day. The risk of daytime drowsiness is greater if you did||
2215|114|P|not get at least 7 hours of sleep or took a higher dose than||
2215|115|P|recommended. If that is the case, you should not drive or do||
2215|116|P|anything that needs alertness the next day. Alcohol or marijuana||
2215|117|P|(cannabis) can also make you more sleepy. Avoid alcoholic||
2215|118|P|beverages. Talk to your doctor if you are using marijuana||
2215|119|P|(cannabis). Do not drive, use machinery, or do anything that||
2215|120|P|needs alertness until you can do it safely.||
2215|121|P|   Before having surgery, tell your doctor or dentist about all||
2215|122|P|the products you use (including prescription drugs,||
2215|123|P|nonprescription drugs, and herbal products).||
2215|124|P|   Older adults may be more sensitive to the side effects of this||
2215|125|P|drug, especially excessive drowsiness. Drowsiness may increase||
2215|126|P|the risk of falls.||
2215|127|P|   During pregnancy, this medication should be used only when||
2215|128|P|clearly needed. Discuss the risks and benefits with your doctor.||
2215|129|P|   This medication passes into breast milk. Consult your doctor||
2215|130|P|before breastfeeding.||
2215|131|B|||
2215|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2215|133|I|medications work or increase your risk for serious side effects.||
2215|134|I|This document does not contain all possible drug interactions.||
2215|135|I|Keep a list of all the products you use (including||
2215|136|I|prescription/nonprescription drugs and herbal products) and share||
2215|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
2215|138|I|the dosage of any medicines without your doctor's approval.||
2215|139|I|   Other medications can affect the removal of lemborexant from||
2215|140|I|your body, which may affect how lemborexant works. Examples||
2215|141|I|include azole antifungals (such as itraconazole), macrolide||
2215|142|I|antibiotics (such as clarithromycin), rifamycins (such as||
2215|143|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
2215|144|I|as carbamazepine, phenytoin), cobicistat, nefazodone, ritonavir,||
2215|145|I|telithromycin, among others.||
2215|146|I|   The risk of serious side effects (such as slow/shallow||
2215|147|I|breathing, severe drowsiness/dizziness) may be increased if this||
2215|148|I|medication is taken with other products that may also cause||
2215|149|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2215|150|I|if you are taking other products such as opioid pain or cough||
2215|151|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2215|152|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
2215|153|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2215|154|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2215|155|I|diphenhydramine).||
2215|156|I|   Check the labels on all your medicines (such as allergy or||
2215|157|I|cough-and-cold products) because they may contain ingredients||
2215|158|I|that cause drowsiness. Ask your pharmacist about using those||
2215|159|I|products safely.||
2215|160|B|||
2215|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2215|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2215|163|O|poison control center right away. US residents can call||
2215|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2215|165|B|||
2215|166|N|NOTES:  Do not share this medication with others. This medication||
2215|167|N|may sometimes cause addiction (see also How to Use section).||
2215|168|N|   As you get older, your sleep pattern may naturally change and||
2215|169|N|your sleep may be interrupted several times during the night.||
2215|170|N|Consult your doctor or pharmacist for ways to improve your sleep||
2215|171|N|without medication, such as avoiding caffeine and alcohol close||
2215|172|N|to bedtime, avoiding daytime naps, and going to bed at the same||
2215|173|N|time each night.||
2215|174|B|||
2215|175|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
2215|176|D|time to sleep for at least 7 hours afterward.||
2215|177|B|||
2215|178|R|STORAGE:  Store at room temperature away from light and moisture.||
2215|179|R|Do not store in the bathroom. Keep all medications away from||
2215|180|R|children and pets.||
2215|181|R|   Do not flush medications down the toilet or pour them into a||
2215|182|R|drain unless instructed to do so. Properly discard this product||
2215|183|R|when it is expired or no longer needed. Consult your pharmacist||
2215|184|R|or local waste disposal company.||
2215|185|B|||
2215|186|A|Information last revised April 2025.||
2215|187|A|Copyright(c) 2025 First Databank, Inc.||
2215|188|B|||
2216|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2216|002|Z|does NOT have all possible information about this product. This||
2216|003|Z|information does not assure that this product is safe, effective,||
2216|004|Z|or appropriate for you. This information is not individual||
2216|005|Z|medical advice and does not substitute for the advice of your||
2216|006|Z|health care professional. Always ask your health care||
2216|007|Z|professional for complete information about this product and your||
2216|008|Z|specific health needs.||
2216|009|B|||
2216|010|T|BIMATOPROST IMPLANT - INTRAOCULAR||
2216|011|F|(bye-MAT-oh-prost)||
2216|012|B|||
2216|013|C|COMMON BRAND NAME(S): Durysta||
2216|014|B|||
2216|015|U|USES:  Bimatoprost is used to treat high pressure inside the eye||
2216|016|U|due to glaucoma (open-angle type) or other eye diseases (such as||
2216|017|U|ocular hypertension). Lowering high pressure inside the eye can||
2216|018|U|help prevent blindness. This medication may work by helping fluid||
2216|019|U|inside the eye to flow out, which lowers pressure inside the eye.||
2216|020|U|   This implant may be placed only one time in each eye.||
2216|021|B|||
2216|022|H|HOW TO USE:  This medication implant is placed in the eye(s) by a||
2216|023|H|health care professional. After it is placed, stay upright for at||
2216|024|H|least 1 hour so the implant can settle in place.||
2216|025|H|   Most people with glaucoma or high pressure in the eye do not||
2216|026|H|have symptoms. To monitor the effect of this medication implant,||
2216|027|H|keep all medical appointments with your doctor.||
2216|028|B|||
2216|029|S|SIDE EFFECTS:  Eye redness, swelling, discomfort, dry eye,||
2216|030|S|blurred vision, and a feeling of a foreign body in the eye may||
2216|031|S|occur after the procedure. If any of these effects last or get||
2216|032|S|worse, tell your doctor or pharmacist promptly.||
2216|033|S|   This medication may slowly (over months to years) cause brown||
2216|034|S|discoloration of the colored portion of the eye (iris). If you||
2216|035|S|are using this product in only one eye, only that iris may change||
2216|036|S|color. These changes may be permanent, but the long-term effects||
2216|037|S|are unknown. Tell your doctor if this occurs, and schedule||
2216|038|S|regular eye exams to monitor it.||
2216|039|S|   Remember that this medication has been prescribed because your||
2216|040|S|doctor has judged that the benefit to you is greater than the||
2216|041|S|risk of side effects. Many people using this medication do not||
2216|042|S|have serious side effects.||
2216|043|S|   Tell your doctor right away if you have any serious side||
2216|044|S|effects, including: vision changes, increased eye||
2216|045|S|pain/swelling/sensitivity to light.||
2216|046|S|   A very serious allergic reaction to this drug is rare.||
2216|047|S|However, get medical help right away if you notice any symptoms||
2216|048|S|of a serious allergic reaction, including: rash, itching/swelling||
2216|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2216|050|S|breathing.||
2216|051|S|   This is not a complete list of possible side effects. If you||
2216|052|S|notice other effects not listed above, contact your doctor or||
2216|053|S|pharmacist.||
2216|054|S|   In the US -||
2216|055|S|   Call your doctor for medical advice about side effects. You||
2216|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2216|057|S|www.fda.gov/medwatch.||
2216|058|S|   In Canada - Call your doctor for medical advice about side||
2216|059|S|effects. You may report side effects to Health Canada at||
2216|060|S|1-866-234-2345.||
2216|061|B|||
2216|062|P|PRECAUTIONS:  Before using bimatoprost, tell your doctor or||
2216|063|P|pharmacist if you are allergic to it; or if you have any other||
2216|064|P|allergies. This product may contain inactive ingredients, which||
2216|065|P|can cause allergic reactions or other problems. Talk to your||
2216|066|P|pharmacist for more details.||
2216|067|P|   Before using this medication, tell your doctor or pharmacist||
2216|068|P|your medical history, especially of: other eye problems (such as||
2216|069|P|eye infection, problems with the cornea or posterior lens||
2216|070|P|capsule), previous eye surgery (such as corneal transplant,||
2216|071|P|endothelial cell transplant).||
2216|072|P|   This drug may cause blurred vision. Do not drive, use||
2216|073|P|machinery, or do anything that needs clear vision until you can||
2216|074|P|do it safely.||
2216|075|P|   Before having surgery, tell your doctor or dentist about all||
2216|076|P|the products you use (including prescription drugs,||
2216|077|P|nonprescription drugs, and herbal products).||
2216|078|P|   During pregnancy, this medication should be used only when||
2216|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
2216|080|P|   It is unknown if this drug passes into breast milk. Consult||
2216|081|P|your doctor before breastfeeding.||
2216|082|B|||
2216|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2216|084|I|medications work or increase your risk for serious side effects.||
2216|085|I|This document does not contain all possible drug interactions.||
2216|086|I|Keep a list of all the products you use (including||
2216|087|I|prescription/nonprescription drugs and herbal products) and share||
2216|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
2216|089|I|the dosage of any medicines without your doctor's approval.||
2216|090|B|||
2216|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2216|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2216|093|O|poison control center right away. US residents can call||
2216|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2216|095|B|||
2216|096|N|NOTES:  Medical tests (such as eye exams) should be done while||
2216|097|N|you are using this medication. Keep all medical appointments.||
2216|098|N|Consult your doctor for more details.||
2216|099|B|||
2216|100|D|MISSED DOSE:  Not applicable.||
2216|101|B|||
2216|102|R|STORAGE:  Not applicable. This type of product is given in a||
2216|103|R|hospital or clinic or doctor's office and will not be stored at||
2216|104|R|home.||
2216|105|B|||
2216|106|A|Information last revised April 2025.||
2216|107|A|Copyright(c) 2025 First Databank, Inc.||
2216|108|B|||
2218|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2218|002|Z|does NOT have all possible information about this product. This||
2218|003|Z|information does not assure that this product is safe, effective,||
2218|004|Z|or appropriate for you. This information is not individual||
2218|005|Z|medical advice and does not substitute for the advice of your||
2218|006|Z|health care professional. Always ask your health care||
2218|007|Z|professional for complete information about this product and your||
2218|008|Z|specific health needs.||
2218|009|B|||
2218|010|T|SELPERCATINIB - ORAL||
2218|011|B|||
2218|012|C|COMMON BRAND NAME(S): Retevmo||
2218|013|B|||
2218|014|U|USES:  This medication is used to treat certain types of cancer||
2218|015|U|(such as lung cancer, thyroid cancer, medullary thyroid cancer,||
2218|016|U|certain other solid tumors). Selpercatinib belongs to a class of||
2218|017|U|drugs known as kinase inhibitors. It works by slowing or stopping||
2218|018|U|the growth of cancer cells.||
2218|019|B|||
2218|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2218|021|H|from your pharmacist before you start taking selpercatinib and||
2218|022|H|each time you get a refill. If you have any questions, ask your||
2218|023|H|doctor or pharmacist.||
2218|024|H|   Take this medication by mouth with or without food as directed||
2218|025|H|by your doctor, usually twice daily or three times daily. Swallow||
2218|026|H|the medication whole. Do not crush or chew.||
2218|027|H|   The dosage is based on your weight, medical condition,||
2218|028|H|response to treatment, and other medications you may be taking.||
2218|029|H|Children's dosage may also be based on body size. Be sure to tell||
2218|030|H|your doctor and pharmacist about all the products you use||
2218|031|H|(including prescription drugs, nonprescription drugs, and herbal||
2218|032|H|products).||
2218|033|H|   Medications that reduce stomach acid (such as antacids, proton||
2218|034|H|pump inhibitors/PPIs, H2 blockers) may make selpercatinib work||
2218|035|H|less well. If you take PPIs (such as lansoprazole, omeprazole),||
2218|036|H|take selpercatinib with food. If you take antacids, take||
2218|037|H|selpercatinib 2 hours before or 2 hours after taking the antacid.||
2218|038|H|If you take H2 blockers (such as famotidine, nizatidine), take||
2218|039|H|selpercatinib 2 hours before or 10 hours after taking the H2||
2218|040|H|blocker.||
2218|041|H|   Use this medication regularly to get the most benefit from it.||
2218|042|H|To help you remember, take it at the same times each day.||
2218|043|H|   Do not increase your dose or use this drug more often or for||
2218|044|H|longer than prescribed. Your condition will not improve any||
2218|045|H|faster, and your risk of serious side effects will increase.||
2218|046|H|   If you vomit your dose of selpercatinib, do not take another||
2218|047|H|dose. Take your next dose at your regular scheduled time. Do not||
2218|048|H|take two doses at the same time.||
2218|049|B|||
2218|050|S|SIDE EFFECTS:  Dry mouth, diarrhea, constipation, headache,||
2218|051|S|cough, swelling ankles/feet, nausea, vomiting, or tiredness may||
2218|052|S|occur. Nausea and vomiting can be severe. In some cases, your||
2218|053|S|doctor may prescribe medication to prevent or relieve nausea and||
2218|054|S|vomiting. Eating several small meals, not eating before||
2218|055|S|treatment, or limiting activity may help lessen some of these||
2218|056|S|effects. If any of these effects last or get worse, tell your||
2218|057|S|doctor or pharmacist promptly.||
2218|058|S|   Remember that this medication has been prescribed because your||
2218|059|S|doctor has judged that the benefit to you is greater than the||
2218|060|S|risk of side effects. Many people using this medication do not||
2218|061|S|have serious side effects.||
2218|062|S|   This medication may raise your blood pressure. Check your||
2218|063|S|blood pressure regularly and tell your doctor if the results are||
2218|064|S|high. Your doctor may control your blood pressure with||
2218|065|S|medication.||
2218|066|S|   Tell your doctor right away if you have any serious side||
2218|067|S|effects, including: easy bruising/bleeding, poor wound healing,||
2218|068|S|signs of underactive thyroid (such as weight gain, unusual||
2218|069|S|tiredness, cold intolerance), signs of liver disease (such as||
2218|070|S|nausea/vomiting that doesn't stop, loss of appetite,||
2218|071|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2218|072|S|of lung problems (such as new or worsening shortness of breath,||
2218|073|S|cough), hip/knee pain (in children).||
2218|074|S|   Get medical help right away if you have any very serious side||
2218|075|S|effects, including: signs of stomach/intestinal bleeding (such as||
2218|076|S|bloody/black/tarry stools, stomach/abdominal pain, bloody vomit,||
2218|077|S|vomit that looks like coffee grounds), fast/irregular heartbeat,||
2218|078|S|severe dizziness, fainting.||
2218|079|S|   Selpercatinib sometimes causes side effects due to the rapid||
2218|080|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
2218|081|S|risk, your doctor may add a medication and tell you to drink||
2218|082|S|plenty of fluids. Tell your doctor right away if you have||
2218|083|S|symptoms such as: low back/side pain (flank pain), signs of||
2218|084|S|kidney problems (such as painful urination, pink/bloody urine,||
2218|085|S|change in the amount of urine), muscle spasms/weakness.||
2218|086|S|   A very serious allergic reaction to this drug is rare.||
2218|087|S|However, get medical help right away if you notice any symptoms||
2218|088|S|of a serious allergic reaction, including: rash, itching/swelling||
2218|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2218|090|S|breathing.||
2218|091|S|   This is not a complete list of possible side effects. If you||
2218|092|S|notice other effects not listed above, contact your doctor or||
2218|093|S|pharmacist.||
2218|094|S|   In the US -||
2218|095|S|   Call your doctor for medical advice about side effects. You||
2218|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2218|097|S|www.fda.gov/medwatch.||
2218|098|S|   In Canada - Call your doctor for medical advice about side||
2218|099|S|effects. You may report side effects to Health Canada at||
2218|100|S|1-866-234-2345.||
2218|101|B|||
2218|102|P|PRECAUTIONS:  Before taking selpercatinib, tell your doctor or||
2218|103|P|pharmacist if you are allergic to it; or if you have any other||
2218|104|P|allergies. This product may contain inactive ingredients, which||
2218|105|P|can cause allergic reactions or other problems. Talk to your||
2218|106|P|pharmacist for more details.||
2218|107|P|   Before using this medication, tell your doctor or pharmacist||
2218|108|P|your medical history, especially of: liver problems, high blood||
2218|109|P|pressure.||
2218|110|P|   Selpercatinib may cause a condition that affects the heart||
2218|111|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2218|112|P|serious (rarely fatal) fast/irregular heartbeat and other||
2218|113|P|symptoms (such as severe dizziness, fainting) that need medical||
2218|114|P|attention right away.||
2218|115|P|   The risk of QT prolongation may be increased if you have||
2218|116|P|certain medical conditions or are taking other drugs that may||
2218|117|P|cause QT prolongation. Before using selpercatinib, tell your||
2218|118|P|doctor or pharmacist of all the drugs you take and if you have||
2218|119|P|any of the following conditions: certain heart problems (heart||
2218|120|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2218|121|P|history of certain heart problems (QT prolongation in the EKG,||
2218|122|P|sudden cardiac death).||
2218|123|P|   Low levels of potassium or magnesium in the blood may also||
2218|124|P|increase your risk of QT prolongation. This risk may increase if||
2218|125|P|you use certain drugs (such as diuretics/"water pills") or if you||
2218|126|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2218|127|P|Talk to your doctor about using selpercatinib safely.||
2218|128|P|   Before having any surgery, tell your doctor or dentist about||
2218|129|P|all the products you use (including prescription drugs,||
2218|130|P|nonprescription drugs, and herbal products). Your doctor or||
2218|131|P|dentist may tell you to stop taking selpercatinib at least 1 week||
2218|132|P|before surgery. This medication may cause wounds to heal more||
2218|133|P|slowly. Follow all instructions about when to stop or restart||
2218|134|P|this medication.||
2218|135|P|   Older adults may be more sensitive to the side effects of this||
2218|136|P|drug, especially QT prolongation (see above).||
2218|137|P|   Tell your doctor if you are pregnant or plan to become||
2218|138|P|pregnant. You should not become pregnant while using||
2218|139|P|selpercatinib. Selpercatinib may harm an unborn baby. Your doctor||
2218|140|P|should order a pregnancy test before you start this medication.||
2218|141|P|Men and women using this medication should ask about reliable||
2218|142|P|forms of birth control during treatment and for some time after||
2218|143|P|the last dose. If you or your partner becomes pregnant, talk to||
2218|144|P|your doctor right away about the risks and benefits of this||
2218|145|P|medication.||
2218|146|P|   It is unknown if this drug passes into breast milk. Because of||
2218|147|P|the possible risk to the infant, breastfeeding is not recommended||
2218|148|P|while using this drug and for some time after the last dose.||
2218|149|P|Consult your doctor before breastfeeding.||
2218|150|B|||
2218|151|I|DRUG INTERACTIONS:  See also How to Use section.||
2218|152|I|   Drug interactions may change how your medications work or||
2218|153|I|increase your risk for serious side effects. This document does||
2218|154|I|not contain all possible drug interactions. Keep a list of all||
2218|155|I|the products you use (including prescription/nonprescription||
2218|156|I|drugs and herbal products) and share it with your doctor and||
2218|157|I|pharmacist. Do not start, stop, or change the dosage of any||
2218|158|I|medicines without your doctor's approval.||
2218|159|I|   This medication can slow down the removal of other medications||
2218|160|I|from your body, which may affect how they work. Examples of||
2218|161|I|affected drugs include tovorafenib, among others.||
2218|162|B|||
2218|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2218|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2218|165|O|poison control center right away. US residents can call||
2218|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2218|167|B|||
2218|168|N|NOTES:  Do not share this medication with others.||
2218|169|N|   Lab and/or medical tests (such as liver/thyroid function,||
2218|170|N|heart exam, blood mineral levels, complete blood counts) should||
2218|171|N|be done before you start taking this medication and while you are||
2218|172|N|taking it. Keep all medical and lab appointments.||
2218|173|B|||
2218|174|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2218|175|D|remember. If it less than 6 hours before the next dose, skip the||
2218|176|D|missed dose. Take your next dose at the regular time. Do not||
2218|177|D|double the dose to catch up.||
2218|178|B|||
2218|179|R|STORAGE:  Store at room temperature away from light and moisture.||
2218|180|R|Do not store in the bathroom. Keep all medications away from||
2218|181|R|children and pets.||
2218|182|R|   Do not flush medications down the toilet or pour them into a||
2218|183|R|drain unless instructed to do so. Properly discard this product||
2218|184|R|when it is expired or no longer needed. Consult your pharmacist||
2218|185|R|or local waste disposal company.||
2218|186|B|||
2218|187|A|Information last revised June 2025.||
2218|188|A|Copyright(c) 2025 First Databank, Inc.||
2218|189|B|||
2219|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2219|002|Z|does NOT have all possible information about this product. This||
2219|003|Z|information does not assure that this product is safe, effective,||
2219|004|Z|or appropriate for you. This information is not individual||
2219|005|Z|medical advice and does not substitute for the advice of your||
2219|006|Z|health care professional. Always ask your health care||
2219|007|Z|professional for complete information about this product and your||
2219|008|Z|specific health needs.||
2219|009|B|||
2219|010|T|SERDEXMETHYLPHENIDATE/DEXMETHYLPHENIDATE - ORAL||
2219|011|F|(SER-dex-METH-il-FEN-i-date/DEX-met-il-FEN-i-date)||
2219|012|B|||
2219|013|C|COMMON BRAND NAME(S): Azstarys||
2219|014|B|||
2219|015|W|WARNING:  Misuse or abuse of this medication may result in||
2219|016|W|serious (possibly fatal) heart and blood pressure problems.||
2219|017|W|   This medication can be habit-forming and should be used||
2219|018|W|cautiously by people who have mental/mood disorders or a||
2219|019|W|substance use disorder (such as overuse of or addiction to||
2219|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
2219|021|W|you have a personal or family history of a substance use||
2219|022|W|disorder. Do not increase your dose, use it more often, or use it||
2219|023|W|for a longer time or in a different way than prescribed. Doing so||
2219|024|W|may result in a decrease in the effect of this drug, drug||
2219|025|W|dependence, or abnormal thoughts/behavior.||
2219|026|W|   Your doctor may monitor you for a while after the medication||
2219|027|W|is stopped, especially if you have taken this drug for a long||
2219|028|W|time or in high doses. (See also How to Use section.)||
2219|029|B|||
2219|030|U|USES:  This combination medication is used to treat attention||
2219|031|U|deficit hyperactivity disorder - ADHD. It works by changing the||
2219|032|U|amounts of certain natural substances in the brain.||
2219|033|U|Serdexmethylphenidate and dexmethylphenidate belong to a class of||
2219|034|U|drugs known as stimulants. This product can help increase your||
2219|035|U|ability to pay attention, stay focused on an activity, and||
2219|036|U|control behavior problems. It may also help you to organize your||
2219|037|U|tasks and improve listening skills.||
2219|038|B|||
2219|039|H|HOW TO USE:  Read the Medication Guide provided by your||
2219|040|H|pharmacist before you start taking||
2219|041|H|serdexmethylphenidate/dexmethylphenidate and each time you get a||
2219|042|H|refill. If you have any questions, ask your doctor or pharmacist.||
2219|043|H|   There are different brands and forms of dexmethylphenidate||
2219|044|H|available. They may not have the same effects and may not be||
2219|045|H|substituted for each other. Do not change brands or forms without||
2219|046|H|consulting your doctor or pharmacist.||
2219|047|H|   Take this medication by mouth with or without food as directed||
2219|048|H|by your doctor, usually once daily in the morning. Taking this||
2219|049|H|medication late in the day may cause trouble sleeping (insomnia).||
2219|050|H|   If you have difficulty swallowing this medication whole, you||
2219|051|H|may sprinkle the entire contents of a capsule on a small amount||
2219|052|H|of applesauce (2 tablespoonfuls) or into 2 ounces/50 milliliters||
2219|053|H|of water just before taking. Swallow the mixture within 10||
2219|054|H|minutes of mixing. Do not save it for future use.||
2219|055|H|   The dosage is based on your medical condition and response to||
2219|056|H|treatment. Your doctor may direct you to gradually increase or||
2219|057|H|decrease your dose. Also, if you have used it for a long time, do||
2219|058|H|not suddenly stop using this drug without consulting your doctor.||
2219|059|H|Carefully follow your doctor's instructions.||
2219|060|H|   Take this medication regularly to get the most benefit from||
2219|061|H|it. To help you remember, take it at the same time each day.||
2219|062|H|   If you suddenly stop using this medication, you may have||
2219|063|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
2219|064|H|other mental/mood changes). To help prevent withdrawal, your||
2219|065|H|doctor may lower your dose slowly. Withdrawal is more likely if||
2219|066|H|you have used dexmethylphenidate for a long time or in high||
2219|067|H|doses. Tell your doctor or pharmacist right away if you have||
2219|068|H|withdrawal.||
2219|069|H|   When this medication is used for a long time, it may not work||
2219|070|H|as well. Talk with your doctor if this medication stops working||
2219|071|H|well.||
2219|072|H|   Though it helps many people, this medication may sometimes||
2219|073|H|cause addiction. This risk may be higher if you have a substance||
2219|074|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2219|075|H|Take this medication exactly as prescribed to lower the risk of||
2219|076|H|addiction. Ask your doctor or pharmacist for more details.||
2219|077|H|   Tell your doctor if your condition does not get better or if||
2219|078|H|it gets worse.||
2219|079|B|||
2219|080|S|SIDE EFFECTS:  Trouble sleeping, nervousness, nausea, stomach||
2219|081|S|pain, headache, loss of appetite, weight loss, or dizziness may||
2219|082|S|occur. If any of these effects last or get worse, tell your||
2219|083|S|doctor or pharmacist promptly.||
2219|084|S|   Remember that this medication has been prescribed because your||
2219|085|S|doctor has judged that the benefit to you is greater than the||
2219|086|S|risk of side effects. Many people using this medication do not||
2219|087|S|have serious side effects.||
2219|088|S|   This medication may raise your blood pressure. Check your||
2219|089|S|blood pressure regularly and tell your doctor if the results are||
2219|090|S|high.||
2219|091|S|   Tell your doctor right away if you have any serious side||
2219|092|S|effects, including: signs of blood flow problems in the fingers||
2219|093|S|or toes (such as coldness, numbness, pain, or skin color||
2219|094|S|changes), unusual wounds on the fingers or toes,||
2219|095|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
2219|096|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
2219|097|S|thoughts of suicide), uncontrolled muscle movements (such as||
2219|098|S|twitching, shaking), sudden outbursts of words/sounds that are||
2219|099|S|hard to control, vision changes (such as blurred vision).||
2219|100|S|   Get medical help right away if you have any very serious side||
2219|101|S|effects, including: fainting, seizure, symptoms of a heart attack||
2219|102|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
2219|103|S|sweating), symptoms of a stroke (such as weakness on one side of||
2219|104|S|the body, trouble speaking, sudden vision changes, confusion).||
2219|105|S|   Rarely, males (including young boys and teens) may have a||
2219|106|S|painful or prolonged erection lasting 4 or more hours while using||
2219|107|S|this medication. Caregivers/parents should also be watchful for||
2219|108|S|this serious side effect in boys. If a painful or prolonged||
2219|109|S|erection occurs, stop using this drug and get medical help right||
2219|110|S|away, or permanent problems could occur. Ask your doctor or||
2219|111|S|pharmacist for more details.||
2219|112|S|   A very serious allergic reaction to this drug is rare.||
2219|113|S|However, get medical help right away if you notice any symptoms||
2219|114|S|of a serious allergic reaction, including: rash, itching/swelling||
2219|115|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2219|116|S|breathing.||
2219|117|S|   This is not a complete list of possible side effects. If you||
2219|118|S|notice other effects not listed above, contact your doctor or||
2219|119|S|pharmacist.||
2219|120|S|   In the US -||
2219|121|S|   Call your doctor for medical advice about side effects. You||
2219|122|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2219|123|S|www.fda.gov/medwatch.||
2219|124|S|   In Canada - Call your doctor for medical advice about side||
2219|125|S|effects. You may report side effects to Health Canada at||
2219|126|S|1-866-234-2345.||
2219|127|B|||
2219|128|P|PRECAUTIONS:  See also Warning section.||
2219|129|P|   Before taking this medication, tell your doctor or pharmacist||
2219|130|P|if you are allergic to serdexmethylphenidate or to||
2219|131|P|dexmethylphenidate; or to methylphenidate; or if you have any||
2219|132|P|other allergies. This product may contain inactive ingredients,||
2219|133|P|which can cause allergic reactions or other problems. Talk to||
2219|134|P|your pharmacist for more details.||
2219|135|P|   Before using this medication, tell your doctor or pharmacist||
2219|136|P|your medical history, especially of: high blood pressure, blood||
2219|137|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
2219|138|P|problems (such as irregular heartbeat, heart failure, previous||
2219|139|P|heart attack, problems with heart structure), family history of||
2219|140|P|heart problems (such as sudden cardiac death, irregular||
2219|141|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
2219|142|P|agitation), personal/family history of mental/mood disorders||
2219|143|P|(such as bipolar disorder, depression, psychosis, suicidal||
2219|144|P|thoughts), personal/family history of uncontrolled muscle||
2219|145|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
2219|146|P|(hyperthyroidism), seizure disorder.||
2219|147|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2219|148|P|can make you more dizzy. Do not drive, use machinery, or do||
2219|149|P|anything that needs alertness until you can do it safely. Limit||
2219|150|P|alcoholic beverages. Talk to your doctor if you are using||
2219|151|P|marijuana (cannabis).||
2219|152|P|   Before having surgery, tell your doctor or dentist about all||
2219|153|P|the products you use (including prescription drugs,||
2219|154|P|nonprescription drugs, and herbal products).||
2219|155|P|   Children (especially those younger than 6) may be more||
2219|156|P|sensitive to the side effects of this drug, especially weight||
2219|157|P|loss. If used for a long time, this drug may affect a child's||
2219|158|P|growth rate, weight, and final adult height. To reduce the risk,||
2219|159|P|the doctor may recommend briefly stopping the medication from||
2219|160|P|time to time. Check the child's weight and height regularly, and||
2219|161|P|consult your doctor or pharmacist for more details.||
2219|162|P|   Older adults may be more sensitive to the side effects of this||
2219|163|P|drug, especially trouble sleeping, weight loss, or chest pain.||
2219|164|P|   During pregnancy, this medication should be used only when||
2219|165|P|clearly needed. Discuss the risks and benefits with your doctor.||
2219|166|P|   This medication passes into breast milk. Consult your doctor||
2219|167|P|before breastfeeding.||
2219|168|B|||
2219|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2219|170|I|medications work or increase your risk for serious side effects.||
2219|171|I|This document does not contain all possible drug interactions.||
2219|172|I|Keep a list of all the products you use (including||
2219|173|I|prescription/nonprescription drugs and herbal products) and share||
2219|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
2219|175|I|the dosage of any medicines without your doctor's approval.||
2219|176|I|   Taking MAO inhibitors with this medication may cause a serious||
2219|177|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2219|178|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2219|179|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2219|180|I|selegiline, tranylcypromine) during treatment with this||
2219|181|I|medication. Most MAO inhibitors should also not be taken for two||
2219|182|I|weeks before treatment with this medication. Ask your doctor when||
2219|183|I|to start or stop taking this medication.||
2219|184|I|   Dexmethylphenidate is very similar to methylphenidate. Do not||
2219|185|I|use medications containing methylphenidate while using||
2219|186|I|dexmethylphenidate.||
2219|187|I|   This medication may interfere with certain medical/lab tests||
2219|188|I|(including brain scan for Parkinson's disease), possibly causing||
2219|189|I|false test results. Make sure lab personnel and all your doctors||
2219|190|I|know you use this drug.||
2219|191|B|||
2219|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2219|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2219|194|O|poison control center right away. US residents can call||
2219|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2219|196|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
2219|197|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
2219|198|O|loss of consciousness.||
2219|199|B|||
2219|200|N|NOTES:  Do not share this medication with others. Sharing it is||
2219|201|N|against the law.||
2219|202|N|   Lab and/or medical tests (such as blood pressure, complete||
2219|203|N|blood count, height/weight monitoring in children) may be done||
2219|204|N|while you are taking this medication. Keep all medical and lab||
2219|205|N|appointments.||
2219|206|B|||
2219|207|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
2219|208|D|in the morning hours. If it is after noon or near the time of the||
2219|209|D|next dose, skip the missed dose. Take your next dose at the||
2219|210|D|regular time. Do not double the dose to catch up.||
2219|211|B|||
2219|212|R|STORAGE:  Store at room temperature away from light and moisture.||
2219|213|R|Do not store in the bathroom. Keep all medications away from||
2219|214|R|children and pets.||
2219|215|R|   Do not flush medications down the toilet or pour them into a||
2219|216|R|drain unless instructed to do so. Properly discard this product||
2219|217|R|when it is expired or no longer needed. Consult your pharmacist||
2219|218|R|or local waste disposal company.||
2219|219|B|||
2219|220|A|Information last revised September 2025.||
2219|221|A|Copyright(c) 2025 First Databank, Inc.||
2219|222|B|||
2220|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2220|002|Z|does NOT have all possible information about this product. This||
2220|003|Z|information does not assure that this product is safe, effective,||
2220|004|Z|or appropriate for you. This information is not individual||
2220|005|Z|medical advice and does not substitute for the advice of your||
2220|006|Z|health care professional. Always ask your health care||
2220|007|Z|professional for complete information about this product and your||
2220|008|Z|specific health needs.||
2220|009|B|||
2220|010|T|LEUPROLIDE MONTHLY (3.75 MG) - INTRAMUSCULAR INJECTION||
2220|011|F|(LOO-proe-lide)||
2220|012|B|||
2220|013|U|USES:  Leuprolide is used to treat advanced prostate cancer. It||
2220|014|U|is not a cure. Most types of prostate cancer need the hormone||
2220|015|U|testosterone to grow and spread. Leuprolide works by reducing the||
2220|016|U|amount of testosterone that the body makes. This helps slow or||
2220|017|U|stop the growth of cancer cells and helps relieve symptoms such||
2220|018|U|as painful/difficult urination. Talk to your doctor about the||
2220|019|U|risks and benefits of treatment.||
2220|020|B|||
2220|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2220|022|H|from your pharmacist before you start using leuprolide and each||
2220|023|H|time you get a refill. If you have any questions, ask your doctor||
2220|024|H|or pharmacist.||
2220|025|H|   This medication is given by injection into a muscle by a||
2220|026|H|health care professional. It is given as directed by your doctor,||
2220|027|H|usually once a month (every 4 weeks). This product slowly||
2220|028|H|releases the medication into your blood over a 1-month period.||
2220|029|H|   Use this medication regularly to get the most benefit from it.||
2220|030|H|To help you remember, mark your calendar with a reminder.||
2220|031|H|   During the first few weeks of treatment, your hormone levels||
2220|032|H|will actually go up before they go down. This is a normal||
2220|033|H|response to this medication. Your symptoms may get worse for a||
2220|034|H|few weeks. If you have prostate cancer that has spread to the||
2220|035|H|spine or caused urinary blockage, you may require closer||
2220|036|H|monitoring by your doctor, especially when you first start||
2220|037|H|treatment. Tell your doctor right away if you have any bone pain,||
2220|038|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
2220|039|H|painful/difficult urination, unusual weakness, or inability to||
2220|040|H|move.||
2220|041|B|||
2220|042|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
2220|043|S|sweats, tiredness, swelling of the ankles/feet, increased||
2220|044|S|urination at night, dizziness, or mild burning/pain/bruising at||
2220|045|S|the injection site may occur. If any of these effects last or get||
2220|046|S|worse, tell your doctor or pharmacist promptly.||
2220|047|S|   Rarely, shrinking of the testicles, breast||
2220|048|S|tenderness/swelling, or reduced sexual interest/ability may also||
2220|049|S|occur as a result of lowered testosterone levels. Talk to your||
2220|050|S|doctor if these effects occur.||
2220|051|S|   Remember that this medication has been prescribed because your||
2220|052|S|doctor has judged that the benefit to you is greater than the||
2220|053|S|risk of side effects. Many people using this medication do not||
2220|054|S|have serious side effects.||
2220|055|S|   Tell your doctor right away if you have any serious side||
2220|056|S|effects, including: new/worsening bone pain, easily broken bones,||
2220|057|S|increased thirst/urination, mental/mood changes (such as||
2220|058|S|depression, thoughts of suicide, mood swings, aggression), signs||
2220|059|S|of liver disease (such as nausea/vomiting that doesn't stop, loss||
2220|060|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2220|061|S|urine).||
2220|062|S|   Get medical help right away if you have any very serious side||
2220|063|S|effects, including: symptoms of a heart attack (such as||
2220|064|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
2220|065|S|signs of a stroke (such as weakness on one side of the body,||
2220|066|S|trouble speaking, sudden vision changes, confusion), seizures,||
2220|067|S|fast/irregular heartbeat, severe dizziness, fainting.||
2220|068|S|   A very serious allergic reaction to this drug is rare.||
2220|069|S|However, get medical help right away if you notice any symptoms||
2220|070|S|of a serious allergic reaction, including: fever, swollen lymph||
2220|071|S|nodes, rash, itching/swelling (especially of the||
2220|072|S|face/tongue/throat), severe dizziness, trouble breathing.||
2220|073|S|   This is not a complete list of possible side effects. If you||
2220|074|S|notice other effects not listed above, contact your doctor or||
2220|075|S|pharmacist.||
2220|076|S|   In the US -||
2220|077|S|   Call your doctor for medical advice about side effects. You||
2220|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2220|079|S|www.fda.gov/medwatch.||
2220|080|S|   In Canada - Call your doctor for medical advice about side||
2220|081|S|effects. You may report side effects to Health Canada at||
2220|082|S|1-866-234-2345.||
2220|083|B|||
2220|084|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
2220|085|P|pharmacist if you are allergic to it; or to similar drugs (such||
2220|086|P|as histrelin, triptorelin); or if you have any other allergies.||
2220|087|P|This product may contain inactive ingredients, which can cause||
2220|088|P|allergic reactions or other problems. Talk to your pharmacist for||
2220|089|P|more details.||
2220|090|P|   Before using this medication, tell your doctor or pharmacist||
2220|091|P|your medical history, especially of: diabetes, heart disease||
2220|092|P|(such as heart attack), stroke, high cholesterol, mental/mood||
2220|093|P|problems (such as depression), seizures.||
2220|094|P|   Leuprolide may weaken your bones and increase your risk for||
2220|095|P|bone loss (osteoporosis) if used for a long time. Before using||
2220|096|P|this medication, tell your doctor or pharmacist if you have||
2220|097|P|osteoporosis or if you have any of the following risk factors for||
2220|098|P|osteoporosis: long-term alcohol use, smoking, family history of||
2220|099|P|osteoporosis and broken bones, use of certain medications (for||
2220|100|P|example, corticosteroids such as prednisone, certain anti-seizure||
2220|101|P|drugs such as phenytoin).||
2220|102|P|   Leuprolide may cause a condition that affects the heart rhythm||
2220|103|P|(QT prolongation). QT prolongation can rarely cause serious||
2220|104|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2220|105|P|as severe dizziness, fainting) that need medical attention right||
2220|106|P|away.||
2220|107|P|   The risk of QT prolongation may be increased if you have||
2220|108|P|certain medical conditions or are taking other drugs that may||
2220|109|P|cause QT prolongation. Before using leuprolide, tell your doctor||
2220|110|P|or pharmacist of all the drugs you take and if you have any of||
2220|111|P|the following conditions: certain heart problems (heart failure,||
2220|112|P|slow heartbeat, QT prolongation in the EKG), family history of||
2220|113|P|certain heart problems (QT prolongation in the EKG, sudden||
2220|114|P|cardiac death).||
2220|115|P|   Low levels of potassium or magnesium in the blood may also||
2220|116|P|increase your risk of QT prolongation. This risk may increase if||
2220|117|P|you use certain drugs (such as diuretics/"water pills") or if you||
2220|118|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2220|119|P|Talk to your doctor about using leuprolide safely.||
2220|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2220|121|P|can make you more dizzy. Do not drive, use machinery, or do||
2220|122|P|anything that needs alertness until you can do it safely. Limit||
2220|123|P|alcoholic beverages. Talk to your doctor if you are using||
2220|124|P|marijuana (cannabis).||
2220|125|P|   Before having surgery, tell your doctor or dentist about all||
2220|126|P|the products you use (including prescription drugs,||
2220|127|P|nonprescription drugs, and herbal products).||
2220|128|P|   Older adults may be more sensitive to the side effects of this||
2220|129|P|drug, especially QT prolongation (see above).||
2220|130|P|   This medication can affect fertility in males. Ask your doctor||
2220|131|P|for more details.||
2220|132|P|   This medication must not be used during pregnancy. It may harm||
2220|133|P|an unborn baby. It is important to prevent pregnancy while using||
2220|134|P|this medication. Consult your doctor for more details and to||
2220|135|P|discuss using reliable forms of non-hormonal birth control (such||
2220|136|P|as condoms, diaphragm with spermicide) while using this||
2220|137|P|medication. If you become pregnant or think you may be pregnant,||
2220|138|P|tell your doctor right away.||
2220|139|P|   It is unknown if leuprolide passes into breast milk. Because||
2220|140|P|of the possible risk to the infant, breastfeeding is not||
2220|141|P|recommended while using this medication. Consult your doctor||
2220|142|P|before breastfeeding.||
2220|143|B|||
2220|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2220|145|I|medications work or increase your risk for serious side effects.||
2220|146|I|This document does not contain all possible drug interactions.||
2220|147|I|Keep a list of all the products you use (including||
2220|148|I|prescription/nonprescription drugs and herbal products) and share||
2220|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
2220|150|I|the dosage of any medicines without your doctor's approval.||
2220|151|I|   This medication may interfere with certain lab tests, possibly||
2220|152|I|causing false test results. Make sure lab personnel and all your||
2220|153|I|doctors know you use this drug.||
2220|154|B|||
2220|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2220|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2220|157|O|poison control center right away. US residents can call||
2220|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2220|159|B|||
2220|160|N|NOTES:  Do not share this medication with others.||
2220|161|N|   Lab and/or medical tests (such as blood testosterone level,||
2220|162|N|PSA blood test, blood glucose, cholesterol/triglyceride levels)||
2220|163|N|should be done while you are using this medication. Keep all||
2220|164|N|medical and lab appointments. Consult your doctor for more||
2220|165|N|details.||
2220|166|B|||
2220|167|D|MISSED DOSE:  It is important to get each dose of this medication||
2220|168|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2220|169|D|right away for a new dosing schedule. Do not double the dose to||
2220|170|D|catch up.||
2220|171|B|||
2220|172|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2220|173|R|doctor's office and will not be stored at home.||
2220|174|B|||
2220|175|A|Information last revised October 2024.||
2220|176|A|Copyright(c) 2025 First Databank, Inc.||
2220|177|B|||
2221|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2221|002|Z|does NOT have all possible information about this product. This||
2221|003|Z|information does not assure that this product is safe, effective,||
2221|004|Z|or appropriate for you. This information is not individual||
2221|005|Z|medical advice and does not substitute for the advice of your||
2221|006|Z|health care professional. Always ask your health care||
2221|007|Z|professional for complete information about this product and your||
2221|008|Z|specific health needs.||
2221|009|B|||
2221|010|T|RIPRETINIB - ORAL||
2221|011|F|(rip-RE-ti-nib)||
2221|012|B|||
2221|013|C|COMMON BRAND NAME(S): Qinlock||
2221|014|B|||
2221|015|U|USES:  This medication is used to treat a certain type of||
2221|016|U|stomach, bowel, or esophagus cancer (gastrointestinal stromal||
2221|017|U|tumor-GIST). Ripretinib belongs to a class of drugs known as||
2221|018|U|kinase inhibitors. It works by slowing or stopping the growth of||
2221|019|U|cancer cells.||
2221|020|B|||
2221|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2221|022|H|from your pharmacist before you start taking ripretinib and each||
2221|023|H|time you get a refill. If you have any questions, ask your doctor||
2221|024|H|or pharmacist.||
2221|025|H|   Take this medication by mouth with or without food as directed||
2221|026|H|by your doctor, usually once daily or twice daily. Swallow the||
2221|027|H|tablets whole. If you vomit after taking a dose, do not take||
2221|028|H|another dose. Take your next dose at the regular time.||
2221|029|H|   The dosage is based on your medical condition, response to||
2221|030|H|treatment, and other medications you may be taking. Be sure to||
2221|031|H|tell your doctor and pharmacist about all the products you use||
2221|032|H|(including prescription drugs, nonprescription drugs, and herbal||
2221|033|H|products).||
2221|034|H|   Take this medication regularly to get the most benefit from||
2221|035|H|it. To help you remember, take it at the same time(s) each day.||
2221|036|H|   Do not increase your dose or use this drug more often or for||
2221|037|H|longer than prescribed. Your condition will not improve any||
2221|038|H|faster, and your risk of serious side effects will increase.||
2221|039|H|   Since this drug can be absorbed through the skin and lungs and||
2221|040|H|may harm an unborn baby, women who are pregnant or who may become||
2221|041|H|pregnant should not handle this medication or breathe the dust||
2221|042|H|from the tablets.||
2221|043|B|||
2221|044|S|SIDE EFFECTS:  Tiredness, muscle ache/pain, constipation or||
2221|045|S|diarrhea, itchy/dry skin, headache, loss of appetite,||
2221|046|S|stomach/abdominal pain, nausea, or vomiting may occur. If any of||
2221|047|S|these effects last or get worse, tell your doctor or pharmacist||
2221|048|S|promptly.||
2221|049|S|   Temporary hair loss may occur. Normal hair growth should||
2221|050|S|return after treatment has ended.||
2221|051|S|   People using this medication may have serious side effects.||
2221|052|S|However, you have been prescribed this drug because your doctor||
2221|053|S|has judged that the benefit to you is greater than the risk of||
2221|054|S|side effects. Careful monitoring by your doctor may decrease your||
2221|055|S|risk.||
2221|056|S|   Tell your doctor right away if you have any serious side||
2221|057|S|effects, including: easy bruising/bleeding, slow wound healing,||
2221|058|S|symptoms of heart failure (such as shortness of breath, swelling||
2221|059|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
2221|060|S|   Treatment with this drug may sometimes cause your hands/feet||
2221|061|S|to develop a skin reaction called hand-foot skin reaction||
2221|062|S|(palmar-plantar erythrodysesthesia). Tell your doctor right away||
2221|063|S|if you experience swelling, pain, redness, peeling, blisters, or||
2221|064|S|tingling/burning of the hands/feet. The symptoms can be made||
2221|065|S|worse by heat/pressure on your hands/feet. Limit your time in the||
2221|066|S|sun. Avoid tanning booths and sunlamps, as well as unnecessary||
2221|067|S|exposure to heat (for example, hot dishwater, long hot baths).||
2221|068|S|Use a sunscreen and wear protective clothing when outdoors. Avoid||
2221|069|S|pressure on elbows, knees, and soles of feet (such as leaning on||
2221|070|S|elbows, kneeling, taking long walks). Wear loose clothing and||
2221|071|S|comfortable shoes. Depending on how severe your hand-foot||
2221|072|S|reaction is, your doctor may give you an additional medication to||
2221|073|S|reduce the symptoms, or stop or delay your medication treatment.||
2221|074|S|   This medication may rarely cause new skin cancers. Your doctor||
2221|075|S|should do regular skin exams before and during treatment. Check||
2221|076|S|your skin and tell your doctor right away if you notice skin||
2221|077|S|changes such as a new wart, skin sore/bump that bleeds or does||
2221|078|S|not heal, change in size or color of a mole.||
2221|079|S|   This medication may raise your blood pressure. Check your||
2221|080|S|blood pressure regularly and tell your doctor if the results are||
2221|081|S|high.||
2221|082|S|   This medication may lower your ability to fight infections.||
2221|083|S|This may make you more likely to get a serious (rarely fatal)||
2221|084|S|infection or make any infection you have worse. Tell your doctor||
2221|085|S|right away if you have any signs of infection (such as sore||
2221|086|S|throat that doesn't go away, fever, chills).||
2221|087|S|   Get medical help right away if you have any very serious side||
2221|088|S|effects, including: signs of a heart attack (such as||
2221|089|S|chest/jaw/left arm pain, shortness of breath, unusual sweating).||
2221|090|S|   A very serious allergic reaction to this drug is rare.||
2221|091|S|However, get medical help right away if you notice any symptoms||
2221|092|S|of a serious allergic reaction, including: rash, itching/swelling||
2221|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2221|094|S|breathing.||
2221|095|S|   This is not a complete list of possible side effects. If you||
2221|096|S|notice other effects not listed above, contact your doctor or||
2221|097|S|pharmacist.||
2221|098|S|   In the US -||
2221|099|S|   Call your doctor for medical advice about side effects. You||
2221|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2221|101|S|www.fda.gov/medwatch.||
2221|102|S|   In Canada - Call your doctor for medical advice about side||
2221|103|S|effects. You may report side effects to Health Canada at||
2221|104|S|1-866-234-2345.||
2221|105|B|||
2221|106|P|PRECAUTIONS:  Before taking ripretinib, tell your doctor or||
2221|107|P|pharmacist if you are allergic to it; or if you have any other||
2221|108|P|allergies. This product may contain inactive ingredients, which||
2221|109|P|can cause allergic reactions or other problems. Talk to your||
2221|110|P|pharmacist for more details.||
2221|111|P|   Before using this medication, tell your doctor or pharmacist||
2221|112|P|your medical history, especially of: high blood pressure, heart||
2221|113|P|disease (such as heart failure, previous heart attack).||
2221|114|P|   Ripretinib can make you more likely to get infections or may||
2221|115|P|make current infections worse. Stay away from anyone who has an||
2221|116|P|infection that may easily spread (such as chickenpox, COVID-19,||
2221|117|P|measles, flu). Talk to your doctor if you have been exposed to an||
2221|118|P|infection or for more details.||
2221|119|P|   Tell your health care professional that you are using||
2221|120|P|ripretinib before having any immunizations/vaccinations. Avoid||
2221|121|P|contact with people who have recently received live vaccines||
2221|122|P|(such as flu vaccine inhaled through the nose).||
2221|123|P|   To lower the chance of getting cut, bruised, or injured, use||
2221|124|P|caution with sharp objects like razors and nail cutters, and||
2221|125|P|avoid activities such as contact sports.||
2221|126|P|   Before having surgery, tell your doctor or dentist about all||
2221|127|P|the products you use (including prescription drugs,||
2221|128|P|nonprescription drugs, and herbal products). Your doctor or||
2221|129|P|dentist may tell you to not take ripretinib for at least 1 week||
2221|130|P|before and at least 2 weeks after surgery. This medication may||
2221|131|P|cause wounds to heal more slowly. Follow all instructions about||
2221|132|P|when to stop or restart this medication.||
2221|133|P|   This medication may make you more sensitive to the sun. Limit||
2221|134|P|your time in the sun while you are using this medication and for||
2221|135|P|at least 1 week after stopping treatment. Avoid tanning booths||
2221|136|P|and sunlamps. Use sunscreen and wear protective clothing when||
2221|137|P|outdoors. Tell your doctor right away if you get sunburned or||
2221|138|P|have skin blisters/redness.||
2221|139|P|   Tell your doctor if you are pregnant or plan to become||
2221|140|P|pregnant. You should not become pregnant while using ripretinib.||
2221|141|P|Ripretinib may harm an unborn baby. Your doctor should order a||
2221|142|P|pregnancy test before you start this medication. Men and women||
2221|143|P|using this medication should ask about reliable forms of birth||
2221|144|P|control during treatment and for at least 1 week after the last||
2221|145|P|dose. If you or your partner becomes pregnant, talk to your||
2221|146|P|doctor right away about the risks and benefits of this||
2221|147|P|medication.||
2221|148|P|   Since this drug can be absorbed through the skin and lungs and||
2221|149|P|may harm an unborn baby, women who are pregnant or who may become||
2221|150|P|pregnant should not handle this medication or breathe the dust||
2221|151|P|from the tablets.||
2221|152|P|   It is unknown if this drug passes into breast milk. Because of||
2221|153|P|the possible risk to the infant, breastfeeding is not recommended||
2221|154|P|while using this drug and for at least 1 week after the last||
2221|155|P|dose. Consult your doctor before breastfeeding.||
2221|156|B|||
2221|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2221|158|I|medications work or increase your risk for serious side effects.||
2221|159|I|This document does not contain all possible drug interactions.||
2221|160|I|Keep a list of all the products you use (including||
2221|161|I|prescription/nonprescription drugs and herbal products) and share||
2221|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
2221|163|I|the dosage of any medicines without your doctor's approval.||
2221|164|I|   Other medications can affect the removal of ripretinib from||
2221|165|I|your body, which may affect how ripretinib works. Examples||
2221|166|I|include rifamycins (such as rifampin, rifabutin), St. John's||
2221|167|I|wort, drugs used to treat seizures (such as carbamazepine,||
2221|168|I|phenytoin), among others.||
2221|169|B|||
2221|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2221|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2221|172|O|poison control center right away. US residents can call||
2221|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2221|174|B|||
2221|175|N|NOTES:  Do not share this medication with others.||
2221|176|N|   Lab and/or medical tests (such as complete blood count, skin||
2221|177|N|exam, heart function) should be done before you start taking this||
2221|178|N|medication and while you are taking it. Keep all medical and lab||
2221|179|N|appointments.||
2221|180|B|||
2221|181|D|MISSED DOSE:  If you are taking this medication once daily and||
2221|182|D|you miss a dose, take it as soon as you remember. If it is more||
2221|183|D|than 8 hours after the missed dose, skip the missed dose. Take||
2221|184|D|your next dose at the regular time. Do not double the dose to||
2221|185|D|catch up.||
2221|186|D|   If you are taking this medication twice daily and you miss a||
2221|187|D|dose, take it as soon as you remember. If it is more than 4 hours||
2221|188|D|after the missed dose, skip the missed dose. Take your next dose||
2221|189|D|at the regular time. Do not double the dose to catch up.||
2221|190|D|   If you have any questions, consult your doctor or pharmacist.||
2221|191|B|||
2221|192|R|STORAGE:  Store in the original container at room temperature||
2221|193|R|away from light and moisture. Do not store in the bathroom. Keep||
2221|194|R|the drying agent (desiccant) in the container. Tightly close the||
2221|195|R|container when not in use. Keep all medications away from||
2221|196|R|children and pets.||
2221|197|R|   Do not flush medications down the toilet or pour them into a||
2221|198|R|drain unless instructed to do so. Properly discard this product||
2221|199|R|when it is expired or no longer needed. Consult your pharmacist||
2221|200|R|or local waste disposal company.||
2221|201|B|||
2221|202|M|MEDICAL ALERT:  Your condition can cause complications in a||
2221|203|M|medical emergency. For information about enrolling in MedicAlert,||
2221|204|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2221|205|B|||
2221|206|A|Information last revised April 2025.||
2221|207|A|Copyright(c) 2025 First Databank, Inc.||
2221|208|B|||
2223|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2223|002|Z|does NOT have all possible information about this product. This||
2223|003|Z|information does not assure that this product is safe, effective,||
2223|004|Z|or appropriate for you. This information is not individual||
2223|005|Z|medical advice and does not substitute for the advice of your||
2223|006|Z|health care professional. Always ask your health care||
2223|007|Z|professional for complete information about this product and your||
2223|008|Z|specific health needs.||
2223|009|B|||
2223|010|T|AZITHROMYCIN 600 MG - ORAL||
2223|011|F|(ay-ZITH-roe-MYE-sin)||
2223|012|B|||
2223|013|C|COMMON BRAND NAME(S): Zithromax||
2223|014|B|||
2223|015|U|USES:  Azithromycin is used to prevent and treat a very serious||
2223|016|U|type of infection (mycobacteria or MAC). It is a macrolide-type||
2223|017|U|antibiotic. It works by stopping the growth of bacteria.||
2223|018|U|   This medication will not work for viral infections (such as||
2223|019|U|common cold, flu). Unnecessary use or misuse of any antibiotic||
2223|020|U|can lead to its decreased effectiveness.||
2223|021|B|||
2223|022|H|HOW TO USE:  Take this medication by mouth, with or without food.||
2223|023|H|You may take this medication with food if stomach upset occurs.||
2223|024|H|   To prevent infection, take this drug as directed by your||
2223|025|H|doctor, usually once a week on the same day each week. Continue||
2223|026|H|to take this medication until your doctor tells you to stop.||
2223|027|H|   To treat infection, take this drug as directed by your doctor,||
2223|028|H|usually once daily. Continue to take this medication until your||
2223|029|H|doctor tells you to stop. Stopping the medication too early may||
2223|030|H|result in a return of the infection. Tell your doctor if your||
2223|031|H|condition lasts or gets worse.||
2223|032|H|   For the best effect, take this antibiotic at evenly spaced||
2223|033|H|times. To help you remember, take this medication at the same||
2223|034|H|time(s) every day.||
2223|035|B|||
2223|036|S|SIDE EFFECTS:  Stomach upset, diarrhea/loose stools, nausea,||
2223|037|S|vomiting, or abdominal pain may occur. If any of these effects||
2223|038|S|last or get worse, tell your doctor or pharmacist promptly.||
2223|039|S|   Remember that this medication has been prescribed because your||
2223|040|S|doctor has judged that the benefit to you is greater than the||
2223|041|S|risk of side effects. Many people using this medication do not||
2223|042|S|have serious side effects.||
2223|043|S|   Tell your doctor right away if you have any serious side||
2223|044|S|effects, including: hearing changes (such as decreased hearing,||
2223|045|S|deafness), eye problems (such as drooping eyelids, blurred||
2223|046|S|vision), difficulty speaking/swallowing, muscle weakness, signs||
2223|047|S|of liver problems (such as nausea/vomiting that doesn't stop,||
2223|048|S|unusual tiredness, severe stomach/abdominal pain, yellowing||
2223|049|S|eyes/skin, dark urine).||
2223|050|S|   Get medical help right away if you have any very serious side||
2223|051|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2223|052|S|fainting.||
2223|053|S|   This medication may rarely cause a severe intestinal condition||
2223|054|S|due to a bacteria called C. difficile. This condition may occur||
2223|055|S|during treatment or weeks to months after treatment has stopped.||
2223|056|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2223|057|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2223|058|S|stool.||
2223|059|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2223|060|S|products because they may make symptoms worse.||
2223|061|S|   Use of this medication for prolonged or repeated periods may||
2223|062|S|result in oral thrush or a new yeast infection. Contact your||
2223|063|S|doctor if you notice white patches in your mouth, a change in||
2223|064|S|vaginal discharge, or other new symptoms.||
2223|065|S|   A very serious allergic reaction to this drug is rare.||
2223|066|S|However, get medical help right away if you notice any symptoms||
2223|067|S|of a serious allergic reaction, including: fever that doesn't go||
2223|068|S|away, new or worsening lymph node swelling, rash,||
2223|069|S|itching/swelling (especially of the face/tongue/throat), severe||
2223|070|S|dizziness, trouble breathing.||
2223|071|S|   An allergic reaction to this medication may return even if you||
2223|072|S|stop the drug. If you have an allergic reaction, continue to||
2223|073|S|watch for any of the above symptoms for several days after your||
2223|074|S|last dose.||
2223|075|S|   This is not a complete list of possible side effects. If you||
2223|076|S|notice other effects not listed above, contact your doctor or||
2223|077|S|pharmacist.||
2223|078|S|   In the US -||
2223|079|S|   Call your doctor for medical advice about side effects. You||
2223|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2223|081|S|www.fda.gov/medwatch.||
2223|082|S|   In Canada - Call your doctor for medical advice about side||
2223|083|S|effects. You may report side effects to Health Canada at||
2223|084|S|1-866-234-2345.||
2223|085|B|||
2223|086|P|PRECAUTIONS:  Before taking azithromycin, tell your doctor or||
2223|087|P|pharmacist if you are allergic to it; or to other antibiotics||
2223|088|P|(such as erythromycin, clarithromycin, telithromycin); or if you||
2223|089|P|have any other allergies. This product may contain inactive||
2223|090|P|ingredients, which can cause allergic reactions or other||
2223|091|P|problems. Talk to your pharmacist for more details.||
2223|092|P|   Before using this medication, tell your doctor or pharmacist||
2223|093|P|your medical history, especially of: liver disease, kidney||
2223|094|P|disease, a certain muscle disease (myasthenia gravis).||
2223|095|P|   Azithromycin may cause a condition that affects the heart||
2223|096|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2223|097|P|serious (rarely fatal) fast/irregular heartbeat and other||
2223|098|P|symptoms (such as severe dizziness, fainting) that need medical||
2223|099|P|attention right away.||
2223|100|P|   The risk of QT prolongation may be increased if you have||
2223|101|P|certain medical conditions or are taking other drugs that may||
2223|102|P|cause QT prolongation. Before using azithromycin, tell your||
2223|103|P|doctor or pharmacist of all the drugs you take and if you have||
2223|104|P|any of the following conditions: certain heart problems (heart||
2223|105|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2223|106|P|history of certain heart problems (QT prolongation in the EKG,||
2223|107|P|sudden cardiac death).||
2223|108|P|   Low levels of potassium or magnesium in the blood may also||
2223|109|P|increase your risk of QT prolongation. This risk may increase if||
2223|110|P|you use certain drugs (such as diuretics/"water pills") or if you||
2223|111|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2223|112|P|Talk to your doctor about using azithromycin safely.||
2223|113|P|   Azithromycin may cause live bacterial vaccines (such as||
2223|114|P|typhoid vaccine) to not work well. Tell your health care||
2223|115|P|professional that you are using azithromycin before having any||
2223|116|P|immunizations/vaccinations.||
2223|117|P|   Before having surgery, tell your doctor or dentist about all||
2223|118|P|the products you use (including prescription drugs,||
2223|119|P|nonprescription drugs, and herbal products).||
2223|120|P|   Older adults may be more sensitive to the side effects of this||
2223|121|P|drug, especially QT prolongation (see above).||
2223|122|P|   During pregnancy, this medication should be used only when||
2223|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
2223|124|P|   This drug passes into breast milk. Consult your doctor before||
2223|125|P|breastfeeding.||
2223|126|B|||
2223|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2223|128|I|medications work or increase your risk for serious side effects.||
2223|129|I|This document does not contain all possible drug interactions.||
2223|130|I|Keep a list of all the products you use (including||
2223|131|I|prescription/nonprescription drugs and herbal products) and share||
2223|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
2223|133|I|the dosage of any medicines without your doctor's approval.||
2223|134|I|   This medication can slow down the removal of other medications||
2223|135|I|from your body, which may affect how they work. Examples of||
2223|136|I|affected drugs include colchicine, among others.||
2223|137|I|   Many drugs besides azithromycin may affect the heart rhythm||
2223|138|I|(QT prolongation), including amiodarone, chloroquine,||
2223|139|I|disopyramide, dofetilide, dronedarone, hydroxychloroquine,||
2223|140|I|ibutilide, pimozide, procainamide, quinidine, sotalol, among||
2223|141|I|others.||
2223|142|B|||
2223|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2223|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2223|145|O|poison control center right away. US residents can call||
2223|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2223|147|B|||
2223|148|N|NOTES:  Do not share this medication with others.||
2223|149|N|   This medication has been prescribed for your current condition||
2223|150|N|only. Do not use it later for another infection unless your||
2223|151|N|doctor tells you to.||
2223|152|B|||
2223|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2223|154|D|remember. If it is near the time of the next dose, skip the||
2223|155|D|missed dose. Take your next dose at the regular time. Do not||
2223|156|D|double the dose to catch up.||
2223|157|B|||
2223|158|R|STORAGE:  Store at room temperature away from light and moisture.||
2223|159|R|Do not store in the bathroom. Keep all medications away from||
2223|160|R|children and pets.||
2223|161|R|   Do not flush medications down the toilet or pour them into a||
2223|162|R|drain unless instructed to do so. Properly discard this product||
2223|163|R|when it is expired or no longer needed. Consult your pharmacist||
2223|164|R|or local waste disposal company.||
2223|165|B|||
2223|166|A|Information last revised December 2024.||
2223|167|A|Copyright(c) 2025 First Databank, Inc.||
2223|168|B|||
2224|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2224|002|Z|does NOT have all possible information about this product. This||
2224|003|Z|information does not assure that this product is safe, effective,||
2224|004|Z|or appropriate for you. This information is not individual||
2224|005|Z|medical advice and does not substitute for the advice of your||
2224|006|Z|health care professional. Always ask your health care||
2224|007|Z|professional for complete information about this product and your||
2224|008|Z|specific health needs.||
2224|009|B|||
2224|010|T|FLUPHENAZINE CONCENTRATE - ORAL||
2224|011|F|(flew-FEN-uh-zeen)||
2224|012|B|||
2224|013|C|COMMON BRAND NAME(S): Prolixin||
2224|014|B|||
2224|015|W|WARNING:  There may be a slightly increased risk of serious,||
2224|016|W|possibly fatal side effects (such as heart failure,||
2224|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
2224|018|W|by older adults with dementia. This medication is not approved||
2224|019|W|for the treatment of dementia-related behavior problems. Discuss||
2224|020|W|the risks and benefits of this medication, as well as other||
2224|021|W|effective and possibly safer treatments for dementia-related||
2224|022|W|behavior problems, with the doctor.||
2224|023|B|||
2224|024|U|USES:  This medication is used to treat certain mental/mood||
2224|025|U|disorders (such as schizophrenia). Fluphenazine belongs to a||
2224|026|U|class of drugs known as antipsychotics. It works by helping to||
2224|027|U|restore the balance of certain natural substances in the brain.||
2224|028|U|   This medication is not recommended for use in children under||
2224|029|U|12 years of age.||
2224|030|B|||
2224|031|H|HOW TO USE:  Take this medication by mouth with or without food||
2224|032|H|as directed by your doctor, usually 1 to 4 times daily. The||
2224|033|H|dosage is based on your age, medical condition, and response to||
2224|034|H|treatment.||
2224|035|H|   Measure carefully and dilute (mix) with 2 ounces (60||
2224|036|H|milliliters) or more of water, milk, juice or non-caffeinated||
2224|037|H|carbonated drink. Do not dilute with coffee, tea, caffeinated||
2224|038|H|colas or apple juice as the drug may lose its effectiveness.||
2224|039|H|   Take immediately after diluting. Do not dilute drug for later||
2224|040|H|use.||
2224|041|H|   Avoid getting the medication on your skin because allergic||
2224|042|H|reactions (contact dermatitis) may occur.||
2224|043|H|   Use this medication regularly to get the most benefit from it.||
2224|044|H|To help you remember, take it at the same time(s) each day.||
2224|045|H|   Do not stop taking this medication without consulting your||
2224|046|H|doctor. Some conditions may become worse when this drug is||
2224|047|H|suddenly stopped. Your dose may need to be gradually decreased.||
2224|048|H|   It may take up to two weeks for the full benefit of this||
2224|049|H|medication to take effect. Tell your doctor if your condition||
2224|050|H|does not get better or if it gets worse.||
2224|051|B|||
2224|052|S|SIDE EFFECTS:  Drowsiness, lethargy, dizziness, lightheadedness,||
2224|053|S|nausea, loss of appetite, sweating, dry mouth, blurred vision,||
2224|054|S|headache, and constipation may occur. If any of these effects||
2224|055|S|last or get worse, tell your doctor or pharmacist promptly.||
2224|056|S|   Dizziness and lightheadedness can increase the risk of||
2224|057|S|falling. Get up slowly when rising from a sitting or lying||
2224|058|S|position.||
2224|059|S|   Tell your doctor right away if any of these side effects||
2224|060|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
2224|061|S|mask-like expression of the face, drooling/trouble swallowing, or||
2224|062|S|shuffling walk. Your doctor may prescribe another medication to||
2224|063|S|decrease these side effects.||
2224|064|S|   Remember that this medication has been prescribed because your||
2224|065|S|doctor has judged that the benefit to you is greater than the||
2224|066|S|risk of side effects. Many people using this medication do not||
2224|067|S|have serious side effects.||
2224|068|S|   Tell your doctor right away if you have any serious side||
2224|069|S|effects, including: unusual mental/mood changes (such as||
2224|070|S|depression, confusion, worsening of psychosis), unusual dreams,||
2224|071|S|frequent urination or difficulty urinating, vision problems,||
2224|072|S|weight change, swelling of the feet/ankles, fainting, skin||
2224|073|S|discoloration, butterfly-shaped facial rash, joint pain,||
2224|074|S|seizures.||
2224|075|S|   In rare instances, this medication may increase your level of||
2224|076|S|a certain hormone (prolactin). For females, this rare increase in||
2224|077|S|prolactin may result in unwanted breast milk, missing/stopped||
2224|078|S|menstrual periods, or difficulty becoming pregnant. For males, it||
2224|079|S|may result in decreased sexual ability, inability to produce||
2224|080|S|sperm, or enlarged breasts. If you develop any of these symptoms,||
2224|081|S|tell your doctor right away.||
2224|082|S|   Rarely, males may have a painful or prolonged erection lasting||
2224|083|S|4 or more hours. If this occurs, stop using this drug and get||
2224|084|S|medical help right away, or permanent problems could occur.||
2224|085|S|   Fluphenazine may rarely cause a condition known as tardive||
2224|086|S|dyskinesia. In some cases, this condition may be permanent. Tell||
2224|087|S|your doctor right away if you develop any unusual/uncontrolled||
2224|088|S|movements (especially of the face, mouth, tongue, arms, or legs).||
2224|089|S|   This medication may rarely cause a very serious condition||
2224|090|S|called neuroleptic malignant syndrome (NMS). Get medical help||
2224|091|S|right away if you have any of the following symptoms: fever,||
2224|092|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
2224|093|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
2224|094|S|signs of kidney problems (such as change in the amount of urine).||
2224|095|S|   This drug may rarely cause serious blood problems (such as||
2224|096|S|agranulocytosis, leukopenia) or liver problems. Get medical help||
2224|097|S|right away if you notice any of the following rare but very||
2224|098|S|serious side effects: signs of infection (such as sore throat||
2224|099|S|that doesn't go away, fever, chills), easy bruising/bleeding,||
2224|100|S|severe stomach/abdominal pain, yellowing of the eyes/skin.||
2224|101|S|   A very serious allergic reaction to this drug is rare.||
2224|102|S|However, get medical help right away if you notice any symptoms||
2224|103|S|of a serious allergic reaction, including: rash, itching/swelling||
2224|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2224|105|S|breathing.||
2224|106|S|   This is not a complete list of possible side effects. If you||
2224|107|S|notice other effects not listed above, contact your doctor or||
2224|108|S|pharmacist.||
2224|109|S|   In the US -||
2224|110|S|   Call your doctor for medical advice about side effects. You||
2224|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2224|112|S|www.fda.gov/medwatch.||
2224|113|S|   In Canada - Call your doctor for medical advice about side||
2224|114|S|effects. You may report side effects to Health Canada at||
2224|115|S|1-866-234-2345.||
2224|116|B|||
2224|117|P|PRECAUTIONS:  Before taking fluphenazine, tell your doctor or||
2224|118|P|pharmacist if you are allergic to it; or to other phenothiazines||
2224|119|P|(such as chlorpromazine, perphenazine); or if you have any other||
2224|120|P|allergies. This product may contain inactive ingredients, which||
2224|121|P|can cause allergic reactions or other problems. Talk to your||
2224|122|P|pharmacist for more details.||
2224|123|P|   Before using this medication, tell your doctor or pharmacist||
2224|124|P|your medical history, especially of: brain damage, nervous system||
2224|125|P|problems (such as CNS depression, cerebrovascular insufficiency,||
2224|126|P|brain tumors, encephalitis, encephalopathy), blood problems (such||
2224|127|P|as leukopenia, thrombocytopenia, agranulocytosis), liver||
2224|128|P|problems, breast cancer, eye problems (such as glaucoma), heart||
2224|129|P|problems (such as very high or very low blood pressure, mitral||
2224|130|P|valve insufficiency), kidney problems, a certain adrenal gland||
2224|131|P|tumor (pheochromocytoma), seizures, exposure to phosphorus||
2224|132|P|insecticides, chronic breathing problems (such as asthma,||
2224|133|P|emphysema, frequent infections), low blood calcium, enlarged||
2224|134|P|prostate, drug or alcohol dependency, Reye's syndrome,||
2224|135|P|dehydration.||
2224|136|P|   Before having surgery or any diagnostic testing, tell your||
2224|137|P|doctor or dentist about all the products you use (including||
2224|138|P|prescription drugs, nonprescription drugs, and herbal products).||
2224|139|P|   This drug may make you dizzy or drowsy or blur your vision.||
2224|140|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
2224|141|P|drowsy. Do not drive, use machinery, or do anything that needs||
2224|142|P|alertness or clear vision until you can do it safely. Avoid||
2224|143|P|alcoholic beverages. Talk to your doctor if you are using||
2224|144|P|marijuana (cannabis).||
2224|145|P|   This medication may make you more sensitive to the sun. Limit||
2224|146|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2224|147|P|sunscreen and wear protective clothing when outdoors. Tell your||
2224|148|P|doctor right away if you get sunburned or have skin||
2224|149|P|blisters/redness.||
2224|150|P|   This medication may make you sweat less, making you more||
2224|151|P|likely to get heat stroke. Avoid doing things that may cause you||
2224|152|P|to overheat, such as hard work or exercise in hot weather, or||
2224|153|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2224|154|P|and dress lightly. If you overheat, quickly look for a place to||
2224|155|P|cool down and rest. Get medical help right away if you have a||
2224|156|P|fever that does not go away, mental/mood changes, headache, or||
2224|157|P|dizziness.||
2224|158|P|   Avoid being exposed to very cold temperatures (such as||
2224|159|P|swimming in cold water). Severe lowering of your body temperature||
2224|160|P|may occur.||
2224|161|P|   Children may be more sensitive to the side effects of this||
2224|162|P|drug, especially the side effect of uncontrolled movements. This||
2224|163|P|is especially true if the child is sick (such as has chickenpox,||
2224|164|P|measles, stomach flu).||
2224|165|P|   Older adults may be more sensitive to the side effects of this||
2224|166|P|drug, especially to facial or muscle twitching, muscle||
2224|167|P|spasms/stiffness, uncontrolled movements (tardive dyskinesia),||
2224|168|P|drowsiness, dizziness, lightheadedness, confusion, and possible||
2224|169|P|effects on blood pressure. Drowsiness, dizziness,||
2224|170|P|lightheadedness, and confusion can increase the risk of falling.||
2224|171|P|   During pregnancy, this medication should be used only when||
2224|172|P|clearly needed. Liver problems or birth defects may occur in||
2224|173|P|infants exposed to this type of medication in the womb. Tell the||
2224|174|P|doctor right away if you notice yellowing of the eyes/skin or||
2224|175|P|dark urine in your infant. Babies born to mothers who have used||
2224|176|P|this drug during the last 3 months of pregnancy may rarely||
2224|177|P|develop symptoms including muscle stiffness or shakiness,||
2224|178|P|drowsiness, feeding/breathing difficulties, or constant crying.||
2224|179|P|If you notice any of these symptoms in your newborn especially||
2224|180|P|during their first month, tell the doctor right away.||
2224|181|P|   Since untreated mental/mood problems (such as schizophrenia)||
2224|182|P|can be a serious condition, do not stop taking this medication||
2224|183|P|unless directed by your doctor. If you are planning pregnancy,||
2224|184|P|become pregnant, or think you may be pregnant, immediately||
2224|185|P|discuss with your doctor the benefits and risks of using this||
2224|186|P|medication during pregnancy.||
2224|187|P|   It is unknown if this medication passes into breast milk.||
2224|188|P|However, similar drugs pass into breast milk. Consult your doctor||
2224|189|P|before breastfeeding.||
2224|190|B|||
2224|191|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2224|192|I|medications work or increase your risk for serious side effects.||
2224|193|I|This document does not contain all possible drug interactions.||
2224|194|I|Keep a list of all the products you use (including||
2224|195|I|prescription/nonprescription drugs and herbal products) and share||
2224|196|I|it with your doctor and pharmacist. Do not start, stop, or change||
2224|197|I|the dosage of any medicines without your doctor's approval.||
2224|198|I|   Some products that may interact with this drug are: guanadrel,||
2224|199|I|guanethidine, lithium.||
2224|200|I|   Tell your doctor or pharmacist if you are taking other||
2224|201|I|products that cause drowsiness such as opioid pain or cough||
2224|202|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2224|203|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2224|204|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2224|205|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2224|206|I|diphenhydramine).||
2224|207|I|   Check the labels on all your medicines (such as allergy or||
2224|208|I|cough-and-cold products) because they may contain ingredients||
2224|209|I|that cause drowsiness. Ask your pharmacist about using those||
2224|210|I|products safely.||
2224|211|I|   This medication may interfere with certain lab tests (such as||
2224|212|I|pregnancy test, phenylketonuria test, some urine tests), possibly||
2224|213|I|causing false test results. Make sure lab personnel and all your||
2224|214|I|doctors know you use this drug.||
2224|215|B|||
2224|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2224|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2224|218|O|poison control center right away. US residents can call||
2224|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2224|220|O|Symptoms of overdose may include: loss of consciousness,||
2224|221|O|seizures, fast/irregular heartbeat, or slow/shallow breathing.||
2224|222|B|||
2224|223|N|NOTES:  Do not share this medication with others.||
2224|224|N|   Lab and/or medical tests (such as liver/kidney function,||
2224|225|N|complete blood counts, eye exams, AIMS test) should be done while||
2224|226|N|you are taking this medication. Keep all medical and lab||
2224|227|N|appointments. Consult your doctor for more details.||
2224|228|B|||
2224|229|D|MISSED DOSE:  If you are taking this medication once daily and||
2224|230|D|you miss a dose, take it as soon as you remember. If it is near||
2224|231|D|the time of the next dose, skip the missed dose. Take your next||
2224|232|D|dose at the regular time. Do not double the dose to catch up.||
2224|233|D|   If you are taking this medication more than once daily and you||
2224|234|D|miss a dose, take it as soon as you remember. If it is more than||
2224|235|D|1 hour after the missed dose, skip the missed dose. Take your||
2224|236|D|next dose at the regular time. Do not double the dose to catch||
2224|237|D|up.||
2224|238|B|||
2224|239|R|STORAGE:  Store at room temperature away from light. Do not||
2224|240|R|freeze. Keep all medications away from children and pets.||
2224|241|R|   Do not flush medications down the toilet or pour them into a||
2224|242|R|drain unless instructed to do so. Properly discard this product||
2224|243|R|when it is expired or no longer needed. Consult your pharmacist||
2224|244|R|or local waste disposal company.||
2224|245|B|||
2224|246|A|Information last revised April 2025.||
2224|247|A|Copyright(c) 2025 First Databank, Inc.||
2224|248|B|||
2225|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2225|002|Z|does NOT have all possible information about this product. This||
2225|003|Z|information does not assure that this product is safe, effective,||
2225|004|Z|or appropriate for you. This information is not individual||
2225|005|Z|medical advice and does not substitute for the advice of your||
2225|006|Z|health care professional. Always ask your health care||
2225|007|Z|professional for complete information about this product and your||
2225|008|Z|specific health needs.||
2225|009|B|||
2225|010|T|DILTIAZEM 24-HOUR SUSTAINED-ACTION CAPSULE - ORAL||
2225|011|F|(dill-TIE-uh-zem)||
2225|012|B|||
2225|013|C|COMMON BRAND NAME(S): Cardizem CD||
2225|014|B|||
2225|015|U|USES:  Diltiazem is used to treat high blood pressure||
2225|016|U|(hypertension) and prevent chest pain (angina). Lowering high||
2225|017|U|blood pressure helps prevent strokes, heart attacks, and kidney||
2225|018|U|problems. When used regularly, diltiazem can decrease the number||
2225|019|U|and severity of episodes of chest pain from angina. It may help||
2225|020|U|increase your ability to exercise.||
2225|021|U|   Diltiazem is called a calcium channel blocker. It works by||
2225|022|U|relaxing blood vessels in the body and heart so blood can flow||
2225|023|U|more easily. Diltiazem also lowers your heart rate. These effects||
2225|024|U|help the heart work less hard and lower blood pressure.||
2225|025|B|||
2225|026|V|OTHER USES:  This section contains uses of this drug that are not||
2225|027|V|listed in the approved professional labeling for the drug but||
2225|028|V|that may be prescribed by your health care professional. Use this||
2225|029|V|drug for a condition that is listed in this section only if it||
2225|030|V|has been so prescribed by your health care professional.||
2225|031|V|   Diltiazem may also be used to control your heart rate if you||
2225|032|V|have a fast/irregular heartbeat (such as atrial fibrillation).||
2225|033|B|||
2225|034|H|HOW TO USE:  Take this medication by mouth with or without food||
2225|035|H|as directed by your doctor, usually once daily. Swallow the||
2225|036|H|capsules whole. Do not crush or chew the capsules. Doing so can||
2225|037|H|release all of the drug at once and may increase your risk of||
2225|038|H|side effects.||
2225|039|H|   Your doctor may gradually increase your dose. Follow your||
2225|040|H|doctor's instructions carefully. The dosage is based on your||
2225|041|H|medical condition, response to treatment, and other medications||
2225|042|H|you may be taking. Be sure to tell your doctor and pharmacist||
2225|043|H|about all the products you use (including prescription drugs,||
2225|044|H|nonprescription drugs, and herbal products).||
2225|045|H|   Use this medication regularly to get the most benefit from it.||
2225|046|H|To help you remember, use it at the same time each day. Keep||
2225|047|H|taking this medication even if you feel well. Most people with||
2225|048|H|high blood pressure do not feel sick. For the treatment of high||
2225|049|H|blood pressure, it may take 2 to 4 weeks before you get the full||
2225|050|H|benefit of this drug.||
2225|051|H|   This medication must be taken regularly to prevent angina. It||
2225|052|H|should not be used to treat angina when it occurs. Use other||
2225|053|H|medications (such as nitroglycerin placed under the tongue) to||
2225|054|H|relieve an angina attack as directed by your doctor. Consult your||
2225|055|H|doctor or pharmacist for details.||
2225|056|H|   Tell your doctor if your condition does not get better or if||
2225|057|H|it gets worse (for example, your blood pressure readings remain||
2225|058|H|high or increase, your chest pain worsens).||
2225|059|B|||
2225|060|S|SIDE EFFECTS:  Dizziness, lightheadedness, weakness, nausea,||
2225|061|S|flushing, constipation, and headache may occur. If any of these||
2225|062|S|effects last or get worse, tell your doctor or pharmacist||
2225|063|S|promptly.||
2225|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
2225|065|S|slowly when rising from a sitting or lying position.||
2225|066|S|   Remember that this medication has been prescribed because your||
2225|067|S|doctor has judged that the benefit to you is greater than the||
2225|068|S|risk of side effects. Many people using this medication do not||
2225|069|S|have serious side effects.||
2225|070|S|   Tell your doctor right away if you have any serious side||
2225|071|S|effects, including: nausea/vomiting that doesn't stop, fainting,||
2225|072|S|new or worsening symptoms of heart failure (such as shortness of||
2225|073|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
2225|074|S|weight gain), slow/irregular/pounding/fast heartbeat, mental/mood||
2225|075|S|changes (such as depression, agitation), unusual dreams, severe||
2225|076|S|stomach/abdominal pain, dark urine, yellowing eyes/skin.||
2225|077|S|   A very serious allergic reaction to this drug is rare.||
2225|078|S|However, get medical help right away if you notice any symptoms||
2225|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2225|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2225|081|S|breathing.||
2225|082|S|   This is not a complete list of possible side effects. If you||
2225|083|S|notice other effects not listed above, contact your doctor or||
2225|084|S|pharmacist.||
2225|085|S|   In the US -||
2225|086|S|   Call your doctor for medical advice about side effects. You||
2225|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2225|088|S|www.fda.gov/medwatch.||
2225|089|S|   In Canada - Call your doctor for medical advice about side||
2225|090|S|effects. You may report side effects to Health Canada at||
2225|091|S|1-866-234-2345.||
2225|092|B|||
2225|093|P|PRECAUTIONS:  Before taking diltiazem, tell your doctor or||
2225|094|P|pharmacist if you are allergic to it; or if you have any other||
2225|095|P|allergies. This product may contain inactive ingredients, which||
2225|096|P|can cause allergic reactions or other problems. Talk to your||
2225|097|P|pharmacist for more details.||
2225|098|P|   Before using this medication, tell your doctor or pharmacist||
2225|099|P|your medical history, especially of: certain types of heart||
2225|100|P|rhythm problems (such as sick sinus syndrome/atrioventricular||
2225|101|P|block), liver disease, kidney disease, heart failure.||
2225|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2225|103|P|can make you more dizzy. Do not drive, use machinery, or do||
2225|104|P|anything that needs alertness until you can do it safely. Limit||
2225|105|P|alcoholic beverages. Talk to your doctor if you are using||
2225|106|P|marijuana (cannabis).||
2225|107|P|   Before having surgery, tell your doctor or dentist about all||
2225|108|P|the products you use (including prescription drugs,||
2225|109|P|nonprescription drugs, and herbal products).||
2225|110|P|   Older adults may be more sensitive to the side effects of this||
2225|111|P|drug, especially dizziness, constipation, or swelling||
2225|112|P|ankles/feet.||
2225|113|P|   During pregnancy, this medication should be used only when||
2225|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
2225|115|P|   This drug passes into breast milk and may have undesirable||
2225|116|P|effects on a nursing infant. Consult your doctor before||
2225|117|P|breastfeeding.||
2225|118|B|||
2225|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2225|120|I|medications work or increase your risk for serious side effects.||
2225|121|I|This document does not contain all possible drug interactions.||
2225|122|I|Keep a list of all the products you use (including||
2225|123|I|prescription/nonprescription drugs and herbal products) and share||
2225|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
2225|125|I|the dosage of any medicines without your doctor's approval.||
2225|126|I|   Some products that may interact with this drug include:||
2225|127|I|digoxin, fingolimod, labetalol.||
2225|128|I|   Other medications can affect the removal of diltiazem from||
2225|129|I|your body, which may affect how this medication works. Examples||
2225|130|I|include azole antifungals (such as ketoconazole), cimetidine,||
2225|131|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
2225|132|I|rifabutin, rifampin), St. John's wort, among others.||
2225|133|I|   This medication can slow down the removal of other medications||
2225|134|I|from your body, which may affect how they work. Examples of||
2225|135|I|affected drugs include aprepitant/fosaprepitant, buspirone,||
2225|136|I|colchicine, elacestrant, flibanserin, ivabradine, lomitapide,||
2225|137|I|certain benzodiazepines (triazolam, midazolam), among others.||
2225|138|I|   Some products have ingredients that could raise your heart||
2225|139|I|rate or blood pressure. Tell your pharmacist what products you||
2225|140|I|are using, and ask how to use them safely (especially||
2225|141|I|cough-and-cold products, diet aids, or NSAIDs such as||
2225|142|I|ibuprofen/naproxen).||
2225|143|B|||
2225|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2225|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2225|146|O|poison control center right away. US residents can call||
2225|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2225|148|B|||
2225|149|N|NOTES:  Do not share this medication with others. Talk with your||
2225|150|N|doctor about making changes to your lifestyle that may help this||
2225|151|N|medication work better (such as stress reduction programs,||
2225|152|N|exercise, and dietary changes).||
2225|153|N|   Lab and/or medical tests (such as kidney/liver function,||
2225|154|N|pulse, blood pressure, EKG) may be done while you are taking this||
2225|155|N|medication. Keep all medical and lab appointments. Consult your||
2225|156|N|doctor for more details.||
2225|157|N|   There are different brands and types of this medication||
2225|158|N|available. Many do not have the same effects. Do not change||
2225|159|N|brands or types without consulting your doctor or pharmacist.||
2225|160|N|   Have your blood pressure and pulse (heart rate) checked||
2225|161|N|regularly while taking this medication. Learn how to check your||
2225|162|N|own blood pressure and pulse at home, and share the results with||
2225|163|N|your doctor.||
2225|164|B|||
2225|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2225|166|D|remember. If it is near the time of the next dose, skip the||
2225|167|D|missed dose. Take your next dose at the regular time. Do not||
2225|168|D|double the dose to catch up.||
2225|169|B|||
2225|170|R|STORAGE:  Store at room temperature away from light and moisture.||
2225|171|R|Do not store in the bathroom. Keep all medications away from||
2225|172|R|children and pets.||
2225|173|R|   Do not flush medications down the toilet or pour them into a||
2225|174|R|drain unless instructed to do so. Properly discard this product||
2225|175|R|when it is expired or no longer needed. Consult your pharmacist||
2225|176|R|or local waste disposal company.||
2225|177|B|||
2225|178|M|MEDICAL ALERT:  Your condition can cause complications in a||
2225|179|M|medical emergency. For information about enrolling in MedicAlert,||
2225|180|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2225|181|B|||
2225|182|A|Information last revised March 2025.||
2225|183|A|Copyright(c) 2025 First Databank, Inc.||
2225|184|B|||
2226|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2226|002|Z|does NOT have all possible information about this product. This||
2226|003|Z|information does not assure that this product is safe, effective,||
2226|004|Z|or appropriate for you. This information is not individual||
2226|005|Z|medical advice and does not substitute for the advice of your||
2226|006|Z|health care professional. Always ask your health care||
2226|007|Z|professional for complete information about this product and your||
2226|008|Z|specific health needs.||
2226|009|B|||
2226|010|T|OZANIMOD - ORAL||
2226|011|F|(oh-ZAN-i-mod)||
2226|012|B|||
2226|013|C|COMMON BRAND NAME(S): Zeposia||
2226|014|B|||
2226|015|U|USES:  This medication is used to treat multiple sclerosis (MS).||
2226|016|U|Ozanimod is not a cure for MS but it is thought to help by||
2226|017|U|preventing immune system cells (lymphocytes) from attacking the||
2226|018|U|nerves in your brain and spinal cord. It helps decrease the||
2226|019|U|number of episodes of disease worsening (relapses) and may||
2226|020|U|prevent or delay disability.||
2226|021|U|   Ozanimod is also used to treat a certain bowel disease||
2226|022|U|(ulcerative colitis). It helps to reduce symptoms of ulcerative||
2226|023|U|colitis such as diarrhea, rectal bleeding, and stomach pain.||
2226|024|B|||
2226|025|H|HOW TO USE:  Read the Medication Guide provided by your||
2226|026|H|pharmacist before you start taking ozanimod and each time you get||
2226|027|H|a refill. If you have any questions, ask your doctor or||
2226|028|H|pharmacist.||
2226|029|H|   Take this medication by mouth with or without food as directed||
2226|030|H|by your doctor, usually once a day or every other day. Swallow||
2226|031|H|the capsule whole.||
2226|032|H|   The dosage is based on your medical condition and response to||
2226|033|H|treatment. To reduce your risk of side effects, your doctor may||
2226|034|H|direct you to start this medication at a low dose and gradually||
2226|035|H|increase your dose. Follow your doctor's instructions carefully.||
2226|036|H|   Take this medication regularly to get the most benefit from||
2226|037|H|it. To help you remember, take it at the same time on the days||
2226|038|H|you are scheduled to take the medication.||
2226|039|H|   Do not increase your dose or take this medication more often||
2226|040|H|than prescribed. Your condition will not improve any faster, and||
2226|041|H|your risk of side effects will increase.||
2226|042|H|   Do not stop taking this medication without consulting your||
2226|043|H|doctor. Your condition may become worse when this drug is||
2226|044|H|suddenly stopped. Consult your doctor or pharmacist for more||
2226|045|H|details. Report any new or worsening symptoms right away.||
2226|046|H|   The manufacturer recommends you avoid certain foods and||
2226|047|H|beverages that are high in tyramine, since these may increase||
2226|048|H|your blood pressure while you are taking ozanimod. These include:||
2226|049|H|aged cheeses, dried/aged meats and sausages (such as salami,||
2226|050|H|liverwurst), preserved fish (such as pickled herring), products||
2226|051|H|that contain large amounts of yeast (such as bouillon cubes,||
2226|052|H|powdered soup/gravy, homemade or sourdough bread), fermented||
2226|053|H|foods (such as sauerkraut, kim chee), most soybean products (such||
2226|054|H|as soy sauce, tofu), broad/fava beans, red wine, sherry, tap||
2226|055|H|beers, vermouth, among others. Ask your doctor or dietician for||
2226|056|H|more details and for a list of foods to limit or avoid.||
2226|057|H|   Tell your doctor if your condition gets worse.||
2226|058|B|||
2226|059|S|SIDE EFFECTS:  Back pain, dizziness, and lightheadedness may||
2226|060|S|occur. Slow heartbeat may also occur, especially when you first||
2226|061|S|start this medication. If any of these effects last or get worse,||
2226|062|S|tell your doctor or pharmacist promptly.||
2226|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
2226|064|S|slowly when rising from a sitting or lying position.||
2226|065|S|   Remember that this medication has been prescribed because your||
2226|066|S|doctor has judged that the benefit to you is greater than the||
2226|067|S|risk of side effects. Many people using this medication do not||
2226|068|S|have serious side effects.||
2226|069|S|   This medication may raise your blood pressure. Check your||
2226|070|S|blood pressure regularly and tell your doctor if the results are||
2226|071|S|high.||
2226|072|S|   Tell your doctor right away if you have any serious side||
2226|073|S|effects, including: signs of liver disease (such as||
2226|074|S|nausea/vomiting that doesn't stop, loss of appetite,||
2226|075|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2226|076|S|shortness of breath, unusual tiredness.||
2226|077|S|   This medication can weaken your immune system/increase the||
2226|078|S|risk of infection while you are taking it and for 3 months after||
2226|079|S|your last dose. You may be more likely to get a serious (possibly||
2226|080|S|fatal) infection (such as bronchitis, herpes). Tell your doctor||
2226|081|S|right away if you develop any signs of an infection (such as sore||
2226|082|S|throat that doesn't go away, difficulty breathing, fever, chills,||
2226|083|S|cough, sores, blisters. Do not start ozanimod if you already have||
2226|084|S|an infection.||
2226|085|S|   This medication may increase your risk of getting a rare but||
2226|086|S|very serious (possibly fatal) brain infection (progressive||
2226|087|S|multifocal leukoencephalopathy-PML). Symptoms of PML can seem||
2226|088|S|like a worsening MS attack. Get medical help right away if you||
2226|089|S|have any of these side effects: clumsiness, loss of||
2226|090|S|coordination/balance, weakness, sudden change in your thinking||
2226|091|S|(such as confusion, difficulty concentrating, memory loss),||
2226|092|S|difficulty talking/walking, seizure.||
2226|093|S|   Get medical help right away if you have any very serious side||
2226|094|S|effects, including: very slow heartbeat, fast/irregular||
2226|095|S|heartbeat, severe dizziness, fainting, eye pain/sensitivity to||
2226|096|S|light, vision changes (such as blurred vision, blind spot/shadows||
2226|097|S|in the center of your vision, color changes), sudden/severe||
2226|098|S|headache.||
2226|099|S|   A very serious allergic reaction to this drug is rare.||
2226|100|S|However, get medical help right away if you notice any symptoms||
2226|101|S|of a serious allergic reaction, including: rash, itching/swelling||
2226|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2226|103|S|breathing.||
2226|104|S|   This is not a complete list of possible side effects. If you||
2226|105|S|notice other effects not listed above, contact your doctor or||
2226|106|S|pharmacist.||
2226|107|S|   In the US -||
2226|108|S|   Call your doctor for medical advice about side effects. You||
2226|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2226|110|S|www.fda.gov/medwatch.||
2226|111|S|   In Canada - Call your doctor for medical advice about side||
2226|112|S|effects. You may report side effects to Health Canada at||
2226|113|S|1-866-234-2345.||
2226|114|B|||
2226|115|P|PRECAUTIONS:  Before taking ozanimod, tell your doctor or||
2226|116|P|pharmacist if you are allergic to it; or if you have any other||
2226|117|P|allergies. This product may contain inactive ingredients which||
2226|118|P|can cause allergic reactions or other problems. Talk to your||
2226|119|P|pharmacist for more details.||
2226|120|P|   Before using this medication, tell your doctor or pharmacist||
2226|121|P|your medical history, especially of: breathing problems (such as||
2226|122|P|asthma, bronchitis, emphysema, sleep apnea),||
2226|123|P|current/recent/returning infection (including hepatitis and||
2226|124|P|tuberculosis), diabetes, certain eye problems (macular edema,||
2226|125|P|uveitis), heart problems (such as slow/irregular heartbeat, heart||
2226|126|P|failure, previous heart attack, chest pain, QT prolongation in||
2226|127|P|the EKG), high blood pressure, liver problems, smoking,||
2226|128|P|stroke/mini-stroke.||
2226|129|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2226|130|P|can make you more dizzy. Do not drive, use machinery, or do||
2226|131|P|anything that needs alertness until you can do it safely. Limit||
2226|132|P|alcoholic beverages. Talk to your doctor if you are using||
2226|133|P|marijuana (cannabis).||
2226|134|P|   Ozanimod can make you more likely to get infections or may||
2226|135|P|make current infections worse. Stay away from anyone who has an||
2226|136|P|infection that may easily spread (such as chickenpox, COVID-19,||
2226|137|P|measles, flu). Talk to your doctor if you have been exposed to an||
2226|138|P|infection or for more details.||
2226|139|P|   Tell your doctor your vaccine history and ask if you need to||
2226|140|P|get any vaccines before starting treatment with this medication.||
2226|141|P|If a live vaccine is needed, it should be given at least one||
2226|142|P|month before starting this medication. Tell your health care||
2226|143|P|professional that you are using ozanimod before having any||
2226|144|P|immunizations/vaccinations. Avoid getting a live vaccine while||
2226|145|P|using this medication and for 3 months after the last dose of||
2226|146|P|this medication. Avoid contact with people who have recently||
2226|147|P|received live vaccines (such as flu vaccine inhaled through the||
2226|148|P|nose).||
2226|149|P|   Before having surgery, tell your doctor or dentist about all||
2226|150|P|the products you use (including prescription drugs,||
2226|151|P|nonprescription drugs, and herbal products).||
2226|152|P|   Tell your doctor if you are pregnant or plan to become||
2226|153|P|pregnant. You should not become pregnant while using ozanimod.||
2226|154|P|Ozanimod may harm an unborn baby. Ask about reliable forms of||
2226|155|P|birth control while using this medication and for 3 months after||
2226|156|P|the last dose. If you become pregnant, talk to your doctor right||
2226|157|P|away about the risks and benefits of this medication.||
2226|158|P|   It is unknown if this medication passes into breast milk.||
2226|159|P|Consult your doctor before breastfeeding.||
2226|160|B|||
2226|161|I|DRUG INTERACTIONS:  See also How to Use section.||
2226|162|I|   Drug interactions may change how your medications work or||
2226|163|I|increase your risk for serious side effects. This document does||
2226|164|I|not contain all possible drug interactions. Keep a list of all||
2226|165|I|the products you use (including prescription/nonprescription||
2226|166|I|drugs and herbal products) and share it with your doctor and||
2226|167|I|pharmacist. Do not start, stop, or change the dosage of any||
2226|168|I|medicines without your doctor's approval.||
2226|169|I|   Some products that may interact with this drug are: other||
2226|170|I|drugs that weaken the immune system/increase the risk of||
2226|171|I|infection (such as natalizumab, rituximab, alemtuzumab).||
2226|172|I|   Do not take any MAO inhibitors (isocarboxazid, linezolid,||
2226|173|I|metaxalone, methylene blue, moclobemide, phenelzine,||
2226|174|I|procarbazine, rasagiline, safinamide, selegiline,||
2226|175|I|tranylcypromine) during treatment with this medication. Most MAO||
2226|176|I|inhibitors should also not be taken for two weeks before and||
2226|177|I|after treatment with this medication. Ask your doctor when to||
2226|178|I|start or stop taking this medication.||
2226|179|B|||
2226|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2226|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2226|182|O|poison control center right away. US residents can call||
2226|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2226|184|B|||
2226|185|N|NOTES:  Do not share this medication with others.||
2226|186|N|   Lab and/or medical tests (such as complete blood count, blood||
2226|187|N|pressure, pulse, EKG, MRI, eye exams, liver/lung function) should||
2226|188|N|be done before you start taking this medication and while you are||
2226|189|N|taking it. Keep all medical and lab appointments. Consult your||
2226|190|N|doctor for more details.||
2226|191|B|||
2226|192|D|MISSED DOSE:  It is very important to follow your treatment||
2226|193|D|schedule as directed by your doctor. Ask your doctor ahead of||
2226|194|D|time what you should do if you miss a dose of ozanimod. If you||
2226|195|D|miss a dose during the first 14 days of treatment, you may need||
2226|196|D|to start at a lower dose again and slowly increase it. If you||
2226|197|D|miss a dose after the first 14 days of treatment, skip the missed||
2226|198|D|dose. Take your next dose at the regular time. Do not double the||
2226|199|D|dose to catch up.||
2226|200|B|||
2226|201|R|STORAGE:  Store at room temperature away from light and moisture.||
2226|202|R|Do not store in the bathroom. Keep all medications away from||
2226|203|R|children and pets.||
2226|204|R|   Do not flush medications down the toilet or pour them into a||
2226|205|R|drain unless instructed to do so. Properly discard this product||
2226|206|R|when it is expired or no longer needed. Consult your pharmacist||
2226|207|R|or local waste disposal company.||
2226|208|B|||
2226|209|A|Information last revised April 2025.||
2226|210|A|Copyright(c) 2025 First Databank, Inc.||
2226|211|B|||
2227|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2227|002|Z|does NOT have all possible information about this product. This||
2227|003|Z|information does not assure that this product is safe, effective,||
2227|004|Z|or appropriate for you. This information is not individual||
2227|005|Z|medical advice and does not substitute for the advice of your||
2227|006|Z|health care professional. Always ask your health care||
2227|007|Z|professional for complete information about this product and your||
2227|008|Z|specific health needs.||
2227|009|B|||
2227|010|T|BEMPEDOIC ACID/EZETIMIBE - ORAL||
2227|011|F|(BEM-pe-DOE-ik AS-id/e-ZET-i-mibe)||
2227|012|B|||
2227|013|C|COMMON BRAND NAME(S): Nexlizet||
2227|014|B|||
2227|015|U|USES:  This combination medication is used along with a proper||
2227|016|U|diet and other medications to help lower "bad" cholesterol (such||
2227|017|U|as LDL) in the blood. Bempedoic acid works by reducing the amount||
2227|018|U|of cholesterol made by the liver. Ezetimibe works by reducing the||
2227|019|U|amount of cholesterol your body absorbs from your diet. Lowering||
2227|020|U|"bad" cholesterol may help to decrease the risk of heart disease||
2227|021|U|and help prevent strokes and heart attacks.||
2227|022|U|   Bempedoic acid, one of the drugs in this product, is also used||
2227|023|U|in people with heart disease or high risk for heart disease to||
2227|024|U|reduce the risk of heart attack or needing heart procedures (such||
2227|025|U|as placing a stent).||
2227|026|U|   In addition to eating a proper diet (such as a||
2227|027|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
2227|028|U|help this medication work better include exercising, losing||
2227|029|U|weight if overweight, and stopping smoking. Consult your doctor||
2227|030|U|for more details.||
2227|031|B|||
2227|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2227|033|H|from your pharmacist before you start taking this product and||
2227|034|H|each time you get a refill. If you have any questions, ask your||
2227|035|H|doctor or pharmacist.||
2227|036|H|   Take this medication by mouth with or without food as directed||
2227|037|H|by your doctor, usually once daily. The manufacturer directs to||
2227|038|H|swallow this medication whole. However, many similar drugs||
2227|039|H|(immediate-release tablets) can be split/crushed. Follow your||
2227|040|H|doctor's directions on how to take this medication.||
2227|041|H|   If taking a bile acid sequestrant (such as cholestyramine,||
2227|042|H|colestipol), take this product at least 2 hours before or 4 hours||
2227|043|H|after taking the bile acid sequestrant. These products may bind||
2227|044|H|to ezetimibe, preventing your body from fully absorbing the drug.||
2227|045|H|   Take this medication regularly to get the most benefit from||
2227|046|H|it. Remember to use it at the same time each day. Keep taking||
2227|047|H|this medication even if you feel well. Most people with high||
2227|048|H|cholesterol do not feel sick.||
2227|049|H|   It is very important to continue to follow your doctor's||
2227|050|H|advice about diet and exercise. It may take up to 12 weeks before||
2227|051|H|you get the full benefit of this drug.||
2227|052|B|||
2227|053|S|SIDE EFFECTS:  Runny/stuffy nose, abdominal pain, or constipation||
2227|054|S|may occur. If any of these effects last or get worse, tell your||
2227|055|S|doctor or pharmacist promptly.||
2227|056|S|   Remember that this medication has been prescribed because your||
2227|057|S|doctor has judged that the benefit to you is greater than the||
2227|058|S|risk of side effects. Many people using this medication do not||
2227|059|S|have serious side effects.||
2227|060|S|   Tell your doctor right away if you have any serious side||
2227|061|S|effects, including: toe/joint pain, difficulty urinating (for||
2227|062|S|example, due to enlarged prostate).||
2227|063|S|   Tendon damage may occur during treatment with this medication.||
2227|064|S|Stop exercising, rest, and get medical help right away if you||
2227|065|S|develop joint/muscle/tendon pain or swelling. Your risk for||
2227|066|S|tendon problems is greater if you are over 60 years of age, if||
2227|067|S|you are taking corticosteroids (such as prednisone) or||
2227|068|S|fluoroquinolones (such as ciprofloxacin), or if you have kidney||
2227|069|S|or tendon problems.||
2227|070|S|   A very serious allergic reaction to this drug is rare.||
2227|071|S|However, get medical help right away if you notice any symptoms||
2227|072|S|of a serious allergic reaction, including: rash, itching/swelling||
2227|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2227|074|S|breathing.||
2227|075|S|   This is not a complete list of possible side effects. If you||
2227|076|S|notice other effects not listed above, contact your doctor or||
2227|077|S|pharmacist.||
2227|078|S|   In the US -||
2227|079|S|   Call your doctor for medical advice about side effects. You||
2227|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2227|081|S|www.fda.gov/medwatch.||
2227|082|S|   In Canada - Call your doctor for medical advice about side||
2227|083|S|effects. You may report side effects to Health Canada at||
2227|084|S|1-866-234-2345.||
2227|085|B|||
2227|086|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2227|087|P|pharmacist if you are allergic to bempedoic acid or ezetimibe; or||
2227|088|P|if you have any other allergies. This product may contain||
2227|089|P|inactive ingredients, which can cause allergic reactions or other||
2227|090|P|problems. Talk to your pharmacist for more details.||
2227|091|P|   Before using this medication, tell your doctor or pharmacist||
2227|092|P|your medical history, especially of: liver disease, kidney||
2227|093|P|disease, gout, tendon problems.||
2227|094|P|   Before having surgery, tell your doctor or dentist about all||
2227|095|P|the products you use (including prescription drugs,||
2227|096|P|nonprescription drugs, and herbal products).||
2227|097|P|   Older adults may be more sensitive to the side effects of this||
2227|098|P|drug, especially tendon problems.||
2227|099|P|   Tell your doctor if you are pregnant or plan to become||
2227|100|P|pregnant. You should not become pregnant while using this||
2227|101|P|product. Bempedoic acid may harm an unborn baby. If you become||
2227|102|P|pregnant, talk to your doctor right away about the risks and||
2227|103|P|benefits of this medication.||
2227|104|P|   This medication passes into breast milk. Because of the||
2227|105|P|possible risk to the infant, breastfeeding is not recommended||
2227|106|P|while using this medication. Consult your doctor before||
2227|107|P|breastfeeding.||
2227|108|B|||
2227|109|I|DRUG INTERACTIONS:  See also How to Use section.||
2227|110|I|   Drug interactions may change how your medications work or||
2227|111|I|increase your risk for serious side effects. This document does||
2227|112|I|not contain all possible drug interactions. Keep a list of all||
2227|113|I|the products you use (including prescription/nonprescription||
2227|114|I|drugs and herbal products) and share it with your doctor and||
2227|115|I|pharmacist. Do not start, stop, or change the dosage of any||
2227|116|I|medicines without your doctor's approval.||
2227|117|B|||
2227|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2227|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2227|120|O|poison control center right away. US residents can call||
2227|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2227|122|B|||
2227|123|N|NOTES:  Do not share this medication with others.||
2227|124|N|   Lab and/or medical tests (such as kidney/liver function, uric||
2227|125|N|acid levels, complete blood count, cholesterol levels) should be||
2227|126|N|done while you are taking this medication. Keep all medical and||
2227|127|N|lab appointments. Consult your doctor for more details.||
2227|128|B|||
2227|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2227|130|D|remember. If it is near the time of the next dose, skip the||
2227|131|D|missed dose. Take your next dose at the regular time. Do not||
2227|132|D|double the dose to catch up.||
2227|133|B|||
2227|134|R|STORAGE:  Store in the original container at room temperature||
2227|135|R|away from light and moisture. Do not store in the bathroom. Keep||
2227|136|R|the drying agent (desiccant) in the bottle. Tightly close the||
2227|137|R|bottle when not in use. Keep all medications away from children||
2227|138|R|and pets.||
2227|139|R|   Do not flush medications down the toilet or pour them into a||
2227|140|R|drain unless instructed to do so. Properly discard this product||
2227|141|R|when it is expired or no longer needed. Consult your pharmacist||
2227|142|R|or local waste disposal company.||
2227|143|B|||
2227|144|A|Information last revised July 2025.||
2227|145|A|Copyright(c) 2025 First Databank, Inc.||
2227|146|B|||
2228|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2228|002|Z|does NOT have all possible information about this product. This||
2228|003|Z|information does not assure that this product is safe, effective,||
2228|004|Z|or appropriate for you. This information is not individual||
2228|005|Z|medical advice and does not substitute for the advice of your||
2228|006|Z|health care professional. Always ask your health care||
2228|007|Z|professional for complete information about this product and your||
2228|008|Z|specific health needs.||
2228|009|B|||
2228|010|T|LACTIC ACID/CITRIC ACID/POTASSIUM BITARTRATE - VAGINAL||
2228|011|F|(LAK-tik AS-id/SIT-rik AS-id/poe-TAS-ee-um bye-TAR-trate)||
2228|012|B|||
2228|013|C|COMMON BRAND NAME(S): Phexxi||
2228|014|B|||
2228|015|U|USES:  This product is used to prevent pregnancy. It contains 3||
2228|016|U|medications: lactic acid, citric acid, and potassium bitartrate.||
2228|017|U|It works mainly by lowering the acid-base balance (pH) of the||
2228|018|U|vagina which prevents the sperm from reaching an egg||
2228|019|U|(fertilization).||
2228|020|U|   This product does not protect against sexually transmitted||
2228|021|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
2228|022|U|an effective barrier method (latex or polyurethane condom/dental||
2228|023|U|dams) during sexual activity will help to decrease your risk of||
2228|024|U|infection.||
2228|025|U|   This product must be used within 1 hour before vaginal||
2228|026|U|intercourse to work well. It will not work if it is used after||
2228|027|U|vaginal intercourse.||
2228|028|B|||
2228|029|H|HOW TO USE:  Read the Patient Information Leaflet and the||
2228|030|H|Instructions for Use that come with this product before you start||
2228|031|H|using this product. If you have any questions, ask your doctor or||
2228|032|H|pharmacist.||
2228|033|H|   This product is for vaginal use only. Wash your hands before||
2228|034|H|and after use. Avoid getting this medication in your eyes. If it||
2228|035|H|gets into your eyes, rinse them with cool water. Call your doctor||
2228|036|H|if eye irritation lasts.||
2228|037|H|   Use this product as directed by your doctor, usually within 1||
2228|038|H|hour before vaginal intercourse. Insert the applicator filled||
2228|039|H|with medication into the vagina and press the plunger to release||
2228|040|H|the product.||
2228|041|H|   Use a new applicator each time you have vaginal intercourse.||
2228|042|H|If you have vaginal intercourse more than 1 time within 1 hour,||
2228|043|H|use a new applicator each time.||
2228|044|B|||
2228|045|S|SIDE EFFECTS:  Vaginal burning or itching may occur. If this||
2228|046|S|effect lasts or gets worse, tell your doctor or pharmacist||
2228|047|S|promptly.||
2228|048|S|   Remember that this medication has been prescribed because your||
2228|049|S|doctor has judged that the benefit to you is greater than the||
2228|050|S|risk of side effects. Many people using this medication do not||
2228|051|S|have serious side effects.||
2228|052|S|   Tell your doctor right away if you have any serious side||
2228|053|S|effects, including: signs of a vaginal infection (such as unusual||
2228|054|S|vaginal discharge/odor), signs of a urinary tract infection (such||
2228|055|S|as burning/painful/frequent/urgent urination, pink/bloody urine,||
2228|056|S|fever).||
2228|057|S|   A very serious allergic reaction to this drug is rare.||
2228|058|S|However, get medical help right away if you notice any symptoms||
2228|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2228|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2228|061|S|breathing.||
2228|062|S|   This is not a complete list of possible side effects. If you||
2228|063|S|notice other effects not listed above, contact your doctor or||
2228|064|S|pharmacist.||
2228|065|S|   In the US -||
2228|066|S|   Call your doctor for medical advice about side effects. You||
2228|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2228|068|S|www.fda.gov/medwatch.||
2228|069|S|   In Canada - Call your doctor for medical advice about side||
2228|070|S|effects. You may report side effects to Health Canada at||
2228|071|S|1-866-234-2345.||
2228|072|B|||
2228|073|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2228|074|P|pharmacist if you are allergic to lactic acid, citric acid, or||
2228|075|P|potassium bitartrate; or if you have any other allergies. This||
2228|076|P|product may contain inactive ingredients, which can cause||
2228|077|P|allergic reactions or other problems. Talk to your pharmacist for||
2228|078|P|more details.||
2228|079|P|   Before using this product, tell your doctor or pharmacist your||
2228|080|P|medical history, especially of: urinary tract problems (such as||
2228|081|P|recurring urinary tract infections).||
2228|082|P|   Before having surgery, tell your doctor or dentist about all||
2228|083|P|the products you use (including prescription drugs,||
2228|084|P|nonprescription drugs, and herbal products).||
2228|085|P|   This product must not be used during pregnancy. If you become||
2228|086|P|pregnant or think you may be pregnant, tell your doctor right||
2228|087|P|away.||
2228|088|P|   It is unknown if this product passes into breast milk. Consult||
2228|089|P|your doctor before breastfeeding.||
2228|090|B|||
2228|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2228|092|I|medications work or increase your risk for serious side effects.||
2228|093|I|This document does not contain all possible drug interactions.||
2228|094|I|Keep a list of all the products you use (including||
2228|095|I|prescription/nonprescription drugs and herbal products) and share||
2228|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
2228|097|I|the dosage of any medicines without your doctor's approval.||
2228|098|I|   A product that may interact with this drug is: a certain birth||
2228|099|I|control device (vaginal ring).||
2228|100|B|||
2228|101|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2228|102|O|has overdosed and has serious symptoms such as passing out or||
2228|103|O|trouble breathing, call 911. Otherwise, call a poison control||
2228|104|O|center right away. US residents can call 1-800-222-1222. Canada||
2228|105|O|residents can call 1-844-764-7669.||
2228|106|B|||
2228|107|N|NOTES:  Do not share this medication with others.||
2228|108|B|||
2228|109|D|MISSED DOSE:  Not applicable.||
2228|110|B|||
2228|111|R|STORAGE:  Store at room temperature. Keep the medication in the||
2228|112|R|original foil pouch until ready to use. Keep all medications away||
2228|113|R|from children and pets.||
2228|114|R|   Do not flush medications down the toilet or pour them into a||
2228|115|R|drain unless instructed to do so. Properly discard this product||
2228|116|R|when it is expired or no longer needed. Consult your pharmacist||
2228|117|R|or local waste disposal company.||
2228|118|B|||
2228|119|A|Information last revised October 2025.||
2228|120|A|Copyright(c) 2025 First Databank, Inc.||
2228|121|B|||
2230|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2230|002|Z|does NOT have all possible information about this product. This||
2230|003|Z|information does not assure that this product is safe, effective,||
2230|004|Z|or appropriate for you. This information is not individual||
2230|005|Z|medical advice and does not substitute for the advice of your||
2230|006|Z|health care professional. Always ask your health care||
2230|007|Z|professional for complete information about this product and your||
2230|008|Z|specific health needs.||
2230|009|B|||
2230|010|T|DOLUTEGRAVIR TABLET - FOR ORAL SUSPENSION||
2230|011|F|(DOE-loo-TEG-ra-vir)||
2230|012|B|||
2230|013|C|COMMON BRAND NAME(S): Tivicay PD||
2230|014|B|||
2230|015|U|USES:  Dolutegravir is used with other HIV medications to help||
2230|016|U|control HIV infection. It helps to decrease the amount of HIV in||
2230|017|U|your body so your immune system can work better. This lowers your||
2230|018|U|chance of getting HIV complications (such as new infections,||
2230|019|U|cancer) and improves your quality of life. Dolutegravir belongs||
2230|020|U|to a class of drugs known as integrase inhibitors. It blocks the||
2230|021|U|virus from growing and infecting more cells.||
2230|022|U|   Dolutegravir is not a cure for HIV infection. To decrease your||
2230|023|U|risk of spreading HIV disease to others, continue to take all HIV||
2230|024|U|medications exactly as prescribed by your doctor. Use an||
2230|025|U|effective barrier method (latex or polyurethane condoms/dental||
2230|026|U|dams) during sexual activity as directed by your doctor. Do not||
2230|027|U|share personal items (such as needles/syringes, toothbrushes, and||
2230|028|U|razors) that may have contacted blood or other body fluids.||
2230|029|U|Consult your doctor or pharmacist for more details.||
2230|030|B|||
2230|031|V|OTHER USES:  This section contains uses of this drug that are not||
2230|032|V|listed in the approved professional labeling for the drug but||
2230|033|V|that may be prescribed by your health care professional. Use this||
2230|034|V|drug for a condition that is listed in this section only if it||
2230|035|V|has been so prescribed by your health care professional.||
2230|036|V|   This product may also be used to reduce the risk of getting||
2230|037|V|HIV infection after contact with the virus (for example, due to a||
2230|038|V|needle stick). Consult your doctor for more details.||
2230|039|B|||
2230|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2230|041|H|from your pharmacist before you start taking dolutegravir and||
2230|042|H|each time you get a refill. If you have any questions, ask your||
2230|043|H|doctor or pharmacist.||
2230|044|H|   Do not change dosage forms of this medication without checking||
2230|045|H|with your doctor or pharmacist.||
2230|046|H|   Take this medication by mouth with or without food as directed||
2230|047|H|by your doctor, usually 1 to 2 times daily.||
2230|048|H|   The tablet(s) may be swallowed whole or mixed in water. Do not||
2230|049|H|chew, cut, or crush the tablet(s).||
2230|050|H|   If you are mixing the tablet(s) in water, place the tablet(s)||
2230|051|H|in the supplied cup with a small amount of water. Ask your doctor||
2230|052|H|or pharmacist how much water you should use to dissolve the||
2230|053|H|tablet(s). Do not use any other liquids. Swirl the mixture gently||
2230|054|H|for 1 to 2 minutes, then drink all of the mixture right away. To||
2230|055|H|make sure you have taken all of the medication, add another small||
2230|056|H|amount of water to the cup, swirl it, and drink it right away.||
2230|057|H|Take this medication within 30 minutes of mixing.||
2230|058|H|   Take this medication at least 2 hours before or 6 hours after||
2230|059|H|taking sucralfate and products containing aluminum or magnesium||
2230|060|H|(such as antacids, laxatives, buffered medications). These||
2230|061|H|products bind with dolutegravir, decreasing its effectiveness.||
2230|062|H|   If you are also taking calcium or iron supplements (including||
2230|063|H|vitamins/minerals that contain calcium or iron), take||
2230|064|H|dolutegravir at least 2 hours before or 6 hours after these||
2230|065|H|products. Or, if you take dolutegravir with food, you can take||
2230|066|H|calcium or iron supplements at the same time.||
2230|067|H|   The dosage is based on your medical condition, response to||
2230|068|H|treatment, age, and other medications you may be taking.||
2230|069|H|Children's dosage is also based on weight. Be sure to tell your||
2230|070|H|doctor and pharmacist about all the products you use (including||
2230|071|H|prescription drugs, nonprescription drugs, and herbal products).||
2230|072|H|   It is very important to keep taking this medication (and other||
2230|073|H|HIV medications) exactly as prescribed by your doctor. Do not||
2230|074|H|skip any doses.||
2230|075|H|   For the best effect, take this medication at evenly spaced||
2230|076|H|times. To help you remember, take this medication at the same||
2230|077|H|time(s) every day.||
2230|078|H|   Do not take more or less of this drug than prescribed or stop||
2230|079|H|taking it (or other HIV medicines) even for a short time unless||
2230|080|H|directed to do so by your doctor. Doing so may cause the amount||
2230|081|H|of virus to increase, make the infection more difficult to treat||
2230|082|H|(resistant), or worsen side effects.||
2230|083|B|||
2230|084|S|SIDE EFFECTS:  Headache and trouble sleeping may occur. If either||
2230|085|S|of these effects lasts or gets worse, tell your doctor or||
2230|086|S|pharmacist promptly.||
2230|087|S|   Remember that this medication has been prescribed because your||
2230|088|S|doctor has judged that the benefit to you is greater than the||
2230|089|S|risk of side effects. Many people using this medication do not||
2230|090|S|have serious side effects.||
2230|091|S|   Tell your doctor right away if you have any serious side||
2230|092|S|effects, including: symptoms of liver problems (such as||
2230|093|S|nausea/vomiting that doesn't stop, loss of appetite,||
2230|094|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2230|095|S|of kidney problems (such as change in the amount of urine),||
2230|096|S|mental/mood changes (such as depression, thoughts of suicide).||
2230|097|S|   As your immune system gets stronger, it can begin to fight off||
2230|098|S|infections you already had, possibly causing disease symptoms to||
2230|099|S|come back. You could also have symptoms if your immune system||
2230|100|S|becomes overactive. This reaction may happen at any time (soon||
2230|101|S|after starting HIV treatment or many months later). Tell your||
2230|102|S|doctor right away if you have any serious symptoms, including:||
2230|103|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
2230|104|S|that doesn't go away, headaches that are severe or don't go away,||
2230|105|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
2230|106|S|changes, signs of infection (such as sore throat that doesn't go||
2230|107|S|away, fever, chills, swollen lymph nodes, non-healing skin||
2230|108|S|sores), signs of an overactive thyroid (such as irritability,||
2230|109|S|nervousness, heat intolerance, fast/pounding/irregular heartbeat.||
2230|110|S|   A very serious allergic reaction to this drug is rare.||
2230|111|S|However, get medical help right away if you notice any symptoms||
2230|112|S|of a serious allergic reaction, including: rash, itching/swelling||
2230|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2230|114|S|breathing.||
2230|115|S|   This is not a complete list of possible side effects. If you||
2230|116|S|notice other effects not listed above, contact your doctor or||
2230|117|S|pharmacist.||
2230|118|S|   In the US -||
2230|119|S|   Call your doctor for medical advice about side effects. You||
2230|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2230|121|S|www.fda.gov/medwatch.||
2230|122|S|   In Canada - Call your doctor for medical advice about side||
2230|123|S|effects. You may report side effects to Health Canada at||
2230|124|S|1-866-234-2345.||
2230|125|B|||
2230|126|P|PRECAUTIONS:  Before taking dolutegravir, tell your doctor or||
2230|127|P|pharmacist if you are allergic to it; or if you have any other||
2230|128|P|allergies. This product may contain inactive ingredients, which||
2230|129|P|can cause allergic reactions or other problems. Talk to your||
2230|130|P|pharmacist for more details.||
2230|131|P|   Before using this medication, tell your doctor or pharmacist||
2230|132|P|your medical history, especially of: liver disease (such as||
2230|133|P|hepatitis B, hepatitis C), kidney disease.||
2230|134|P|   Before having surgery, tell your doctor or dentist about all||
2230|135|P|the products you use (including prescription drugs,||
2230|136|P|nonprescription drugs, and herbal products).||
2230|137|P|   Tell your doctor if you are pregnant before using this||
2230|138|P|medication. Treatment can lower the risk of passing HIV infection||
2230|139|P|to your baby. Discuss the risks and benefits with your doctor.||
2230|140|P|   This medication passes into breast milk. Because breast milk||
2230|141|P|may transmit HIV, consult your doctor before breastfeeding.||
2230|142|B|||
2230|143|I|DRUG INTERACTIONS:  See also How to Use section.||
2230|144|I|   Drug interactions may change how your medications work or||
2230|145|I|increase your risk for serious side effects. This document does||
2230|146|I|not contain all possible drug interactions. Keep a list of all||
2230|147|I|the products you use (including prescription/nonprescription||
2230|148|I|drugs and herbal products) and share it with your doctor and||
2230|149|I|pharmacist. Do not start, stop, or change the dosage of any||
2230|150|I|medicines without your doctor's approval.||
2230|151|I|   Some products that may interact with this drug are:||
2230|152|I|dofetilide, orlistat.||
2230|153|B|||
2230|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2230|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2230|156|O|poison control center right away. US residents can call||
2230|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2230|158|B|||
2230|159|N|NOTES:  Do not share this medication with others.||
2230|160|N|   Lab and/or medical tests (such as liver/kidney function, viral||
2230|161|N|load, T-cell counts) should be done while you are taking this||
2230|162|N|medication. Keep all medical and lab appointments. Consult your||
2230|163|N|doctor for more details.||
2230|164|B|||
2230|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2230|166|D|remember. If it is near the time of the next dose, skip the||
2230|167|D|missed dose. Take your next dose at the regular time. Do not||
2230|168|D|double the dose to catch up.||
2230|169|B|||
2230|170|R|STORAGE:  Store in the original bottle at room temperature away||
2230|171|R|from light and moisture. Do not store in the bathroom. Keep the||
2230|172|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
2230|173|R|when not in use. Keep all medications away from children and||
2230|174|R|pets.||
2230|175|R|   Do not flush medications down the toilet or pour them into a||
2230|176|R|drain unless instructed to do so. Properly discard this product||
2230|177|R|when it is expired or no longer needed. Consult your pharmacist||
2230|178|R|or local waste disposal company.||
2230|179|B|||
2230|180|A|Information last revised April 2025.||
2230|181|A|Copyright(c) 2025 First Databank, Inc.||
2230|182|B|||
2231|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2231|002|Z|does NOT have all possible information about this product. This||
2231|003|Z|information does not assure that this product is safe, effective,||
2231|004|Z|or appropriate for you. This information is not individual||
2231|005|Z|medical advice and does not substitute for the advice of your||
2231|006|Z|health care professional. Always ask your health care||
2231|007|Z|professional for complete information about this product and your||
2231|008|Z|specific health needs.||
2231|009|B|||
2231|010|T|TELOTRISTAT - ORAL||
2231|011|F|(tel-OH-tri-stat)||
2231|012|B|||
2231|013|C|COMMON BRAND NAME(S): Xermelo||
2231|014|B|||
2231|015|U|USES:  This medication is used along with another drug (a||
2231|016|U|somatostatin analog such as octreotide) to treat diarrhea due to||
2231|017|U|carcinoid syndrome. Telotristat helps to reduce the number of||
2231|018|U|bowel movements that you may have.||
2231|019|B|||
2231|020|H|HOW TO USE:  Take this medication by mouth with food as directed||
2231|021|H|by your doctor, usually 3 times a day.||
2231|022|H|   If using short-acting octreotide with this medication, take||
2231|023|H|this medication at least 30 minutes before using octreotide.||
2231|024|H|Octreotide may decrease the amount of telotristat in the body.||
2231|025|H|   Use this medication regularly to get the most benefit from it.||
2231|026|H|To help you remember, take it at the same times each day.||
2231|027|H|   Tell your doctor if your condition does not get better or if||
2231|028|H|it gets worse.||
2231|029|B|||
2231|030|S|SIDE EFFECTS:  Headache, decreased appetite, gas, or constipation||
2231|031|S|may occur. If any of these effects last or get worse, tell your||
2231|032|S|doctor or pharmacist promptly.||
2231|033|S|   Remember that this medication has been prescribed because your||
2231|034|S|doctor has judged that the benefit to you is greater than the||
2231|035|S|risk of side effects. Many people using this medication do not||
2231|036|S|have serious side effects.||
2231|037|S|   Tell your doctor right away if you have any serious side||
2231|038|S|effects, including: abdominal pain that is severe or doesn't go||
2231|039|S|away, severe constipation, swelling hands/ankles/feet.||
2231|040|S|   A very serious allergic reaction to this drug is rare.||
2231|041|S|However, get medical help right away if you notice any symptoms||
2231|042|S|of a serious allergic reaction, including: rash, itching/swelling||
2231|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2231|044|S|breathing.||
2231|045|S|   This is not a complete list of possible side effects. If you||
2231|046|S|notice other effects not listed above, contact your doctor or||
2231|047|S|pharmacist.||
2231|048|S|   In the US -||
2231|049|S|   Call your doctor for medical advice about side effects. You||
2231|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2231|051|S|www.fda.gov/medwatch.||
2231|052|S|   In Canada - Call your doctor for medical advice about side||
2231|053|S|effects. You may report side effects to Health Canada at||
2231|054|S|1-866-234-2345.||
2231|055|B|||
2231|056|P|PRECAUTIONS:  Before taking telotristat, tell your doctor or||
2231|057|P|pharmacist if you are allergic to it or if you have any other||
2231|058|P|allergies. This product may contain inactive ingredients, which||
2231|059|P|can cause allergic reactions or other problems. Talk to your||
2231|060|P|pharmacist for more details.||
2231|061|P|   Before using this medication, tell your doctor or pharmacist||
2231|062|P|your medical history, especially of: liver problems.||
2231|063|P|   Before having surgery, tell your doctor or dentist about all||
2231|064|P|the products you use (including prescription drugs,||
2231|065|P|nonprescription drugs, and herbal products).||
2231|066|P|   During pregnancy, this medication should be used only when||
2231|067|P|clearly needed. Discuss the risks and benefits with your doctor.||
2231|068|P|   It is unknown if this medication passes into breast milk.||
2231|069|P|Consult your doctor before breastfeeding.||
2231|070|B|||
2231|071|I|DRUG INTERACTIONS:  See also How to Use section.||
2231|072|I|   Drug interactions may change how your medications work or||
2231|073|I|increase your risk for serious side effects. This document does||
2231|074|I|not contain all possible drug interactions. Keep a list of all||
2231|075|I|the products you use (including prescription/nonprescription||
2231|076|I|drugs and herbal products) and share it with your doctor and||
2231|077|I|pharmacist. Do not start, stop, or change the dosage of any||
2231|078|I|medicines without your doctor's approval.||
2231|079|I|   This medication can speed up the removal of other medications||
2231|080|I|from your body, which may affect how they work. Examples of||
2231|081|I|affected drugs include daridorexant, elacestrant, mavacamten,||
2231|082|I|midazolam, quizartinib, among others.||
2231|083|I|   This medication may decrease the effectiveness of hormonal||
2231|084|I|birth control such as pills, patch, or ring. This could cause||
2231|085|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2231|086|I|use reliable backup birth control methods while using this||
2231|087|I|medication. Also tell your doctor if you have any new spotting or||
2231|088|I|breakthrough bleeding, because these may be signs that your birth||
2231|089|I|control is not working well.||
2231|090|B|||
2231|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2231|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2231|093|O|poison control center right away. US residents can call||
2231|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2231|095|B|||
2231|096|N|NOTES:  Do not share this medication with others.||
2231|097|B|||
2231|098|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2231|099|D|next dose at the regular time. Do not double the dose to catch||
2231|100|D|up.||
2231|101|B|||
2231|102|R|STORAGE:  Store at room temperature away from light and moisture.||
2231|103|R|Do not store in the bathroom. Keep all medications away from||
2231|104|R|children and pets.||
2231|105|R|   Do not flush medications down the toilet or pour them into a||
2231|106|R|drain unless instructed to do so. Properly discard this product||
2231|107|R|when it is expired or no longer needed. Consult your pharmacist||
2231|108|R|or local waste disposal company.||
2231|109|B|||
2231|110|A|Information last revised March 2025.||
2231|111|A|Copyright(c) 2025 First Databank, Inc.||
2231|112|B|||
2232|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2232|002|Z|does NOT have all possible information about this product. This||
2232|003|Z|information does not assure that this product is safe, effective,||
2232|004|Z|or appropriate for you. This information is not individual||
2232|005|Z|medical advice and does not substitute for the advice of your||
2232|006|Z|health care professional. Always ask your health care||
2232|007|Z|professional for complete information about this product and your||
2232|008|Z|specific health needs.||
2232|009|B|||
2232|010|T|ELAGOLIX/ESTRADIOL/NORETHINDRONE AND ELAGOLIX - ORAL||
2232|011|F|(EL-a-GOE-lix/ES-tra-DYE-ol/nor-ETH-in-drone and EL-a-GOE-lix)||
2232|012|B|||
2232|013|C|COMMON BRAND NAME(S): Oriahnn||
2232|014|B|||
2232|015|W|WARNING:  Combination hormone treatment increases the risk of||
2232|016|W|blood clot problems, including clots in the legs, lungs, and||
2232|017|W|heart. Do not use this medication if you smoke cigarettes/use||
2232|018|W|tobacco and are over 35 years old. Smoking raises your risk of||
2232|019|W|stroke, heart attack, blood clots, and high blood pressure from||
2232|020|W|this product. The risk of these serious problems increases with||
2232|021|W|age and with the number of cigarettes you smoke. Do not smoke or||
2232|022|W|use tobacco.||
2232|023|B|||
2232|024|U|USES:  This product has 2 different capsules. One capsule||
2232|025|U|contains a combination of 3 medications: elagolix, estradiol, and||
2232|026|U|norethindrone. The other capsule contains only elagolix.||
2232|027|U|   It is used by women who have not gone through menopause to||
2232|028|U|help manage heavy menstrual bleeding due to uterine fibroids.||
2232|029|U|Elagolix works by decreasing your body's production of certain||
2232|030|U|hormones (luteinizing hormone, follicle-stimulating hormone),||
2232|031|U|which leads to lower amounts of female sex hormones (estrogens).||
2232|032|U|Estradiol is used to decrease bone loss caused by elagolix, while||
2232|033|U|norethindrone is used to help lessen the risk of cancer of the||
2232|034|U|uterus due to estradiol.||
2232|035|B|||
2232|036|H|HOW TO USE:  Read the Medication Guide provided by your||
2232|037|H|pharmacist before you start taking this product and each time you||
2232|038|H|get a refill. If you have any questions, ask your doctor or||
2232|039|H|pharmacist.||
2232|040|H|   To make sure you are not pregnant, your doctor may do a||
2232|041|H|pregnancy test before you start taking this medication, or tell||
2232|042|H|you to start taking it within 7 days after the start of your||
2232|043|H|menstrual period. Start taking this medication only when directed||
2232|044|H|by your doctor.||
2232|045|H|   Take the combination medication capsule (elagolix, estradiol,||
2232|046|H|norethindrone) by mouth with or without food as directed by your||
2232|047|H|doctor, usually once daily in the morning. Take the single||
2232|048|H|medication (elagolix) capsule by mouth with or without food as||
2232|049|H|directed by your doctor, usually once daily in the evening. Use||
2232|050|H|this medication regularly to get the most benefit from it. To||
2232|051|H|help you remember, take it at the same times each day. To lessen||
2232|052|H|the risk of bone loss (osteoporosis), your doctor may tell you to||
2232|053|H|stop taking this medication after 24 months. Talk with your||
2232|054|H|doctor for details.||
2232|055|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2232|056|H|using this medication unless your doctor or pharmacist says you||
2232|057|H|may do so safely. Grapefruit can increase the chance of side||
2232|058|H|effects with this medicine. Ask your doctor or pharmacist for||
2232|059|H|more details.||
2232|060|H|   Tell your doctor if your condition does not get better or if||
2232|061|H|it gets worse.||
2232|062|B|||
2232|063|S|SIDE EFFECTS:  Hot flashes, headache, tiredness, or menstrual||
2232|064|S|period changes may occur. If any of these effects last or get||
2232|065|S|worse, tell your doctor or pharmacist promptly.||
2232|066|S|   Hair thinning and hair loss may occur. It is unknown if normal||
2232|067|S|hair growth will return after treatment has ended.||
2232|068|S|   Remember that this medication has been prescribed because your||
2232|069|S|doctor has judged that the benefit to you is greater than the||
2232|070|S|risk of side effects. Many people using this medication do not||
2232|071|S|have serious side effects.||
2232|072|S|   This medication may raise your blood pressure. Check your||
2232|073|S|blood pressure regularly and tell your doctor if the results are||
2232|074|S|high.||
2232|075|S|   Tell your doctor right away if you have any serious side||
2232|076|S|effects, including: lumps in the breast, mental/mood changes||
2232|077|S|(such as new or worsening depression, anxiety, unusual changes in||
2232|078|S|behavior), signs of liver damage (such as nausea/vomiting that||
2232|079|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
2232|080|S|eyes/skin, dark urine), unusual changes in vaginal bleeding (such||
2232|081|S|as continuous spotting, sudden heavy bleeding), symptoms of high||
2232|082|S|blood sugar (such as increased thirst/urination).||
2232|083|S|   Get medical help right away if you have any very serious side||
2232|084|S|effects, including: thoughts of suicide.||
2232|085|S|   The elagolix in this medication lowers estrogen levels in your||
2232|086|S|body. Low estrogen levels can lead to bone loss (osteoporosis).||
2232|087|S|The risk is increased with higher doses or with longer use of||
2232|088|S|this medication. Some bone loss may be permanent. Talk with your||
2232|089|S|doctor about the risks and benefits of taking this medication,||
2232|090|S|and ask about taking calcium supplements and vitamin D for bone||
2232|091|S|health.||
2232|092|S|   This medication may rarely cause serious (sometimes fatal)||
2232|093|S|problems from blood clots (such as heart attack, stroke, blood||
2232|094|S|clots in the lungs or legs). Get medical help right away if you||
2232|095|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
2232|096|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
2232|097|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2232|098|S|trouble speaking, weakness on one side of the body, sudden vision||
2232|099|S|changes.||
2232|100|S|   A very serious allergic reaction to this drug is rare.||
2232|101|S|However, get medical help right away if you notice any symptoms||
2232|102|S|of a serious allergic reaction, including: rash, itching/swelling||
2232|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2232|104|S|breathing.||
2232|105|S|   This is not a complete list of possible side effects. If you||
2232|106|S|notice other effects not listed above, contact your doctor or||
2232|107|S|pharmacist.||
2232|108|S|   In the US -||
2232|109|S|   Call your doctor for medical advice about side effects. You||
2232|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2232|111|S|www.fda.gov/medwatch.||
2232|112|S|   In Canada - Call your doctor for medical advice about side||
2232|113|S|effects. You may report side effects to Health Canada at||
2232|114|S|1-866-234-2345.||
2232|115|B|||
2232|116|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2232|117|P|pharmacist if you are allergic to elagolix, estradiol, or||
2232|118|P|norethindrone; or to any estrogens (such as mestranol) or any||
2232|119|P|progestins (such as desogestrel) or if you have any other||
2232|120|P|allergies. This product may contain inactive ingredients (such as||
2232|121|P|tartrazine), which can cause allergic reactions or other||
2232|122|P|problems. Talk to your pharmacist for more details.||
2232|123|P|   Before using this medication, tell your doctor or pharmacist||
2232|124|P|your medical history, especially of: blood clotting disorders||
2232|125|P|(such as protein C or protein S deficiency), high blood pressure,||
2232|126|P|abnormal breast exam, bone loss (osteoporosis), cancer||
2232|127|P|(especially endometrial or breast cancer), high cholesterol or||
2232|128|P|triglyceride (blood fat) levels, diabetes, family or personal||
2232|129|P|history of a certain swelling disorder (angioedema), gallbladder||
2232|130|P|problems, severe headaches/migraines, heart problems (such as||
2232|131|P|heart valve disease, irregular heartbeat, previous heart attack),||
2232|132|P|history of yellowing eyes/skin (jaundice) during pregnancy or||
2232|133|P|while using hormonal birth control (such as pills, patch), kidney||
2232|134|P|disease, liver disease (including tumors), mental/mood disorders||
2232|135|P|(such as depression), obesity, stroke, swelling (edema), thyroid||
2232|136|P|problems, unexplained vaginal bleeding.||
2232|137|P|   This medication may cause blotchy, dark areas on your skin||
2232|138|P|(melasma). Sunlight may worsen this effect. Avoid prolonged sun||
2232|139|P|exposure, sunlamps, and tanning booths. Use a sunscreen, and wear||
2232|140|P|protective clothing when outdoors.||
2232|141|P|   Tell your doctor if you just had or will be having surgery or||
2232|142|P|if you will be confined to a bed or chair for a long time (such||
2232|143|P|as a long plane flight). These conditions increase your risk of||
2232|144|P|getting blood clots, especially if you are using hormone||
2232|145|P|replacement. You may need to stop this medication for a time||
2232|146|P|(such as 4 to 6 weeks before surgery) or take special||
2232|147|P|precautions. If your doctor tells you to stop this medication||
2232|148|P|before surgery, ask for specific directions about when to restart||
2232|149|P|this medication.||
2232|150|P|   This product must not be used during pregnancy. It may harm an||
2232|151|P|unborn baby. Ask about reliable forms of non-hormonal birth||
2232|152|P|control (such as condoms, spermicide) while using this medication||
2232|153|P|and for 4 weeks after stopping treatment. Because this medication||
2232|154|P|affects menstruation, it may be harder to tell if you are||
2232|155|P|pregnant. If you become pregnant or think you may be pregnant,||
2232|156|P|tell your doctor right away.||
2232|157|P|   It is unknown if elagolix passes into breast milk. A small||
2232|158|P|amount of estradiol and norethindrone passes into breast milk and||
2232|159|P|may have undesirable effects on a nursing infant. Consult your||
2232|160|P|doctor before breastfeeding.||
2232|161|B|||
2232|162|I|DRUG INTERACTIONS:  See also How to Use section.||
2232|163|I|   Drug interactions may change how your medications work or||
2232|164|I|increase your risk for serious side effects. This document does||
2232|165|I|not contain all possible drug interactions. Keep a list of all||
2232|166|I|the products you use (including prescription/nonprescription||
2232|167|I|drugs and herbal products) and share it with your doctor and||
2232|168|I|pharmacist. Do not start, stop, or change the dosage of any||
2232|169|I|medicines without your doctor's approval.||
2232|170|I|   Some products that may interact with this drug are: aromatase||
2232|171|I|inhibitors (such as anastrozole, exemestane, letrozole),||
2232|172|I|fezolinetant, ospemifene, tamoxifen, tranexamic acid.||
2232|173|I|   Other medications can affect the removal of this medication||
2232|174|I|from your body, which may affect how it works. Examples include||
2232|175|I|belumosudil, cyclosporine, encorafenib, gemfibrozil, letermovir,||
2232|176|I|resmetirom, vadadustat, voclosporin, among others.||
2232|177|I|   This medication can speed up the removal of other medications||
2232|178|I|from your body, which may affect how they work. Examples of||
2232|179|I|affected drugs include daridorexant, elacestrant, mavacamten,||
2232|180|I|quizartinib, revumenib, among others.||
2232|181|B|||
2232|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2232|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2232|184|O|poison control center right away. US residents can call||
2232|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2232|186|B|||
2232|187|N|NOTES:  Do not share this medication with others.||
2232|188|N|   Lab and/or medical tests (such as liver function, cholesterol,||
2232|189|N|pregnancy test, blood pressure, bone density tests) may be done||
2232|190|N|before you start taking this medication and while you are taking||
2232|191|N|it. Keep all medical and lab appointments.||
2232|192|B|||
2232|193|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2232|194|D|remember. If it is more than 4 hours after the missed dose, skip||
2232|195|D|the missed dose. Take your next dose at the regular time. Do not||
2232|196|D|double the dose to catch up.||
2232|197|B|||
2232|198|R|STORAGE:  Store at room temperature away from light and moisture.||
2232|199|R|Do not store in the bathroom. Keep all medications away from||
2232|200|R|children and pets.||
2232|201|R|   Do not flush medications down the toilet or pour them into a||
2232|202|R|drain unless instructed to do so. Properly discard this product||
2232|203|R|when it is expired or no longer needed. Consult your pharmacist||
2232|204|R|or local waste disposal company.||
2232|205|B|||
2232|206|A|Information last revised October 2025.||
2232|207|A|Copyright(c) 2025 First Databank, Inc.||
2232|208|B|||
2233|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2233|002|Z|does NOT have all possible information about this product. This||
2233|003|Z|information does not assure that this product is safe, effective,||
2233|004|Z|or appropriate for you. This information is not individual||
2233|005|Z|medical advice and does not substitute for the advice of your||
2233|006|Z|health care professional. Always ask your health care||
2233|007|Z|professional for complete information about this product and your||
2233|008|Z|specific health needs.||
2233|009|B|||
2233|010|T|INSULIN LISPRO-AABC - INJECTION||
2233|011|F|(IN-su-lin LIS-proe)||
2233|012|B|||
2233|013|C|COMMON BRAND NAME(S): Lyumjev||
2233|014|B|||
2233|015|U|USES:  Insulin lispro-aabc is used with a proper diet and||
2233|016|U|exercise program to control high blood sugar in people with||
2233|017|U|diabetes. Controlling high blood sugar helps prevent kidney||
2233|018|U|damage, blindness, nerve problems, loss of limbs, and sexual||
2233|019|U|function problems. Proper control of diabetes may also lessen||
2233|020|U|your risk of a heart attack or stroke.||
2233|021|U|   Insulin lispro-aabc is a man-made product that is similar to||
2233|022|U|human insulin. It replaces the insulin that your body would||
2233|023|U|normally make. Insulin lispro-aabc starts working faster and||
2233|024|U|lasts for a shorter time than regular insulin. It works by||
2233|025|U|helping blood sugar (glucose) get into cells so your body can use||
2233|026|U|it for energy. This medication is usually used with a medium- or||
2233|027|U|long-acting insulin product. Insulin lispro-aabc may also be used||
2233|028|U|with other oral diabetes medications (such as sulfonylureas like||
2233|029|U|glyburide or glipizide).||
2233|030|B|||
2233|031|H|HOW TO USE:  Read the Patient Information Leaflet and||
2233|032|H|Instructions for Use if available from your pharmacist before you||
2233|033|H|start using this medication and each time you get a refill. Ask||
2233|034|H|your health care professional how to prepare and use this||
2233|035|H|medication. If you have any questions, ask your doctor or||
2233|036|H|pharmacist.||
2233|037|H|   Inject this medication under the skin as directed by your||
2233|038|H|doctor, usually at the start of a meal or within 20 minutes after||
2233|039|H|starting a meal. Because this insulin is fast-acting, not eating||
2233|040|H|right after a dose of insulin may lead to low blood sugar||
2233|041|H|(hypoglycemia). Do not inject if you have low blood sugar. The||
2233|042|H|injection is given in the stomach area, the thigh, the buttocks,||
2233|043|H|or the back of the upper arm. Do not inject into a vein or muscle||
2233|044|H|because very low blood sugar may occur.||
2233|045|H|   The dosage is based on your medical condition and response to||
2233|046|H|treatment. Measure each dose very carefully because even small||
2233|047|H|changes in the amount of insulin may have a large effect on your||
2233|048|H|blood sugar.||
2233|049|H|   Before using, check this product for particles or||
2233|050|H|discoloration. If either is present, do not use the insulin.||
2233|051|H|Before injecting each dose, clean the skin you are going to||
2233|052|H|inject into (the injection site) with rubbing alcohol. Change the||
2233|053|H|injection site each time to lessen injury under the skin (for||
2233|054|H|example, pits/lumps or thickened skin). Do not inject into skin||
2233|055|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
2233|056|H|not rub the injection site after a shot. Do not inject cold||
2233|057|H|insulin because this can be painful. The insulin container you||
2233|058|H|are currently using can be kept at room temperature. Learn how to||
2233|059|H|store and discard medical supplies safely.||
2233|060|H|   Giving insulin lispro-aabc into a vein should only be done by||
2233|061|H|a health care professional. Very low blood sugar may result.||
2233|062|H|   If you are directed to inject this insulin with an infusion||
2233|063|H|pump, read the instruction manual and directions that come with||
2233|064|H|the infusion pump. If you have any questions, ask your health||
2233|065|H|care professional. Avoid exposing the pump or its tubing to||
2233|066|H|direct sunlight or other heat sources. Do not dilute insulin if||
2233|067|H|you are using an insulin pump.||
2233|068|H|   Do not mix insulin lispro-aabc with other insulins.||
2233|069|H|   Do not change brands or types of insulin without directions on||
2233|070|H|how to do so from your doctor.||
2233|071|H|   Do not share your pen device with another person, even if the||
2233|072|H|needle is changed. You may give other people a serious infection,||
2233|073|H|or get a serious infection from them.||
2233|074|H|   Use this medication regularly to get the most benefit from it.||
2233|075|H|To help you remember, use it at the same times each day.||
2233|076|H|   Tell your doctor if your condition does not get better or if||
2233|077|H|it gets worse (your blood sugar is too high or too low).||
2233|078|B|||
2233|079|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
2233|080|S|irritation) or weight gain may occur. If any of these effects||
2233|081|S|last or get worse, tell your doctor or pharmacist promptly.||
2233|082|S|   Remember that this medication has been prescribed because your||
2233|083|S|doctor has judged that the benefit to you is greater than the||
2233|084|S|risk of side effects. Many people using this medication do not||
2233|085|S|have serious side effects.||
2233|086|S|   Tell your doctor right away if you have any serious side||
2233|087|S|effects, including: signs of low potassium level in the blood||
2233|088|S|(such as muscle cramps, weakness, irregular heartbeat).||
2233|089|S|   This medication can cause low blood sugar (hypoglycemia). This||
2233|090|S|may occur if you do not get enough calories from food or if you||
2233|091|S|do unusually heavy exercise. Symptoms of low blood sugar include||
2233|092|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
2233|093|S|dizziness, or tingling hands/feet. It is a good habit to carry||
2233|094|S|glucose tablets or gel to treat low blood sugar. If you don't||
2233|095|S|have these reliable forms of glucose, rapidly raise your blood||
2233|096|S|sugar by eating a quick source of sugar such as table sugar,||
2233|097|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
2233|098|S|doctor right away about the reaction and the use of this product.||
2233|099|S|To help prevent low blood sugar, eat meals on a regular schedule,||
2233|100|S|and do not skip meals. Check with your doctor or pharmacist to||
2233|101|S|find out what you should do if you miss a meal.||
2233|102|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
2233|103|S|thirst/urination. If these symptoms occur, tell your doctor right||
2233|104|S|away. Your doctor may need to adjust your diabetes medication,||
2233|105|S|exercise program, or diet.||
2233|106|S|   A very serious allergic reaction to this drug is rare.||
2233|107|S|However, get medical help right away if you notice any symptoms||
2233|108|S|of a serious allergic reaction, including: rash, itching/swelling||
2233|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2233|110|S|breathing.||
2233|111|S|   This is not a complete list of possible side effects. If you||
2233|112|S|notice other effects not listed above, contact your doctor or||
2233|113|S|pharmacist.||
2233|114|S|   In the US -||
2233|115|S|   Call your doctor for medical advice about side effects. You||
2233|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2233|117|S|www.fda.gov/medwatch.||
2233|118|S|   In Canada - Call your doctor for medical advice about side||
2233|119|S|effects. You may report side effects to Health Canada at||
2233|120|S|1-866-234-2345.||
2233|121|B|||
2233|122|P|PRECAUTIONS:  Before using insulin lispro-aabc, tell your doctor||
2233|123|P|or pharmacist if you are allergic to it; or to other insulins||
2233|124|P|(such as insulin lispro); or if you have any other allergies.||
2233|125|P|This product may contain inactive ingredients, which can cause||
2233|126|P|allergic reactions or other problems. Talk to your pharmacist for||
2233|127|P|more details.||
2233|128|P|   Do not use this medication when you have low blood sugar||
2233|129|P|(hypoglycemia).||
2233|130|P|   Before using this medication, tell your doctor or pharmacist||
2233|131|P|your medical history, especially of: kidney disease, liver||
2233|132|P|disease, thyroid problems.||
2233|133|P|   You may experience blurred vision, dizziness, or drowsiness||
2233|134|P|due to extremely low or high blood sugar. Do not drive, use||
2233|135|P|machinery, or do anything that needs alertness or clear vision||
2233|136|P|until you can do it safely.||
2233|137|P|   Limit alcohol while using this medication because it can||
2233|138|P|increase your risk of developing low blood sugar.||
2233|139|P|   It may be harder to control your blood sugar when your body is||
2233|140|P|stressed (such as due to fever, infection, injury, or surgery).||
2233|141|P|Consult your doctor because this may require a change in your||
2233|142|P|treatment plan, medications, or blood sugar testing.||
2233|143|P|   Before having surgery, tell your doctor or dentist about all||
2233|144|P|the products you use (including prescription drugs,||
2233|145|P|nonprescription drugs, and herbal products).||
2233|146|P|   Check your blood sugar before and after exercise. You may need||
2233|147|P|a snack beforehand.||
2233|148|P|   If traveling across time zones, ask your doctor about how to||
2233|149|P|adjust your insulin schedule. Take extra insulin and supplies||
2233|150|P|with you.||
2233|151|P|   Older adults may be more sensitive to the side effects of this||
2233|152|P|drug, especially low blood sugar.||
2233|153|P|   Children may be more sensitive to the side effects of this||
2233|154|P|drug, especially low blood sugar and injection site reactions.||
2233|155|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
2233|156|P|cause or worsen diabetes. Discuss a plan with your doctor for||
2233|157|P|managing your blood sugar while pregnant. Your doctor may change||
2233|158|P|your diabetes treatment during your pregnancy (such as diet and||
2233|159|P|medications including insulin).||
2233|160|P|   This medication passes into breast milk, but is unlikely to||
2233|161|P|harm a nursing infant. Consult your doctor before breastfeeding.||
2233|162|P|Your insulin needs may change while breastfeeding.||
2233|163|B|||
2233|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2233|165|I|medications work or increase your risk for serious side effects.||
2233|166|I|This document does not contain all possible drug interactions.||
2233|167|I|Keep a list of all the products you use (including||
2233|168|I|prescription/nonprescription drugs and herbal products) and share||
2233|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
2233|170|I|the dosage of any medicines without your doctor's approval.||
2233|171|I|   Beta-blocker medications (such as metoprolol, propranolol,||
2233|172|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
2233|173|I|heartbeat you would usually feel when your blood sugar falls too||
2233|174|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
2233|175|I|dizziness, hunger, or sweating, are not affected by these drugs.||
2233|176|I|   Many drugs can affect your blood sugar, making it harder to||
2233|177|I|control. Before you start, stop, or change any medication, talk||
2233|178|I|with your doctor or pharmacist about how the medication may||
2233|179|I|affect your blood sugar. Check your blood sugar regularly as||
2233|180|I|directed and share the results with your doctor. Tell your doctor||
2233|181|I|right away if you have symptoms of high or low blood sugar. (See||
2233|182|I|also Side Effects section.) Your doctor may need to adjust your||
2233|183|I|diabetes medication, exercise program, or diet.||
2233|184|I|   Insulin lispro-aabc is very similar to insulin lispro. Do not||
2233|185|I|use insulin lispro while using insulin lispro-aabc.||
2233|186|B|||
2233|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2233|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2233|189|O|poison control center right away. US residents can call||
2233|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2233|191|O|Symptoms of overdose may include: signs of low blood sugar such||
2233|192|O|as sweating, shakiness, seizures, loss of consciousness, fast||
2233|193|O|heartbeat.||
2233|194|B|||
2233|195|N|NOTES:  Do not share this medication, needles, or syringes with||
2233|196|N|others.||
2233|197|N|   Attend a diabetes education program to learn more about how to||
2233|198|N|manage your diabetes with medications, diet, exercise, and||
2233|199|N|regular medical exams.||
2233|200|N|   Learn the symptoms of high and low blood sugar and how to||
2233|201|N|treat low blood sugar. Check your blood sugar regularly as||
2233|202|N|directed and share the results with your doctor.||
2233|203|N|   Lab and/or medical tests (such as liver/kidney function,||
2233|204|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
2233|205|N|should be done while you are using this medication. Keep all||
2233|206|N|medical and lab appointments.||
2233|207|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
2233|208|B|||
2233|209|D|MISSED DOSE:  It is very important to follow your insulin regimen||
2233|210|D|exactly. Ask your doctor ahead of time what you should do if you||
2233|211|D|miss a dose of insulin.||
2233|212|B|||
2233|213|R|STORAGE:  Store all unopened insulin products in the||
2233|214|R|refrigerator. Opened insulin lispro-aabc vials may be stored in||
2233|215|R|the refrigerator or at room temperature. Opened insulin||
2233|216|R|lispro-aabc cartridges and prefilled pens can only be stored at||
2233|217|R|room temperature and should not be refrigerated. Throw away all||
2233|218|R|insulin lispro-aabc in use or stored at room temperature after 28||
2233|219|R|days, even if there is insulin left. Also throw away all insulin||
2233|220|R|products after the expiration date on the package. Do not freeze||
2233|221|R|and do not use insulin that has been frozen.||
2233|222|R|   If using this drug in an insulin pump, do not store this drug||
2233|223|R|in the pump for more than 9 days. Doing so may lead to||
2233|224|R|ineffective treatment and high blood sugar. Do not expose the||
2233|225|R|insulin in your pump to direct sunlight or temperatures above||
2233|226|R|98.6 degrees F (37 degrees C).||
2233|227|R|   Protect insulin from light and heat. Do not store in the||
2233|228|R|bathroom. Keep all medications away from children and pets.||
2233|229|R|   Do not flush medications down the toilet or pour them into a||
2233|230|R|drain unless instructed to do so. Properly discard this product||
2233|231|R|when it is expired or no longer needed. Consult your pharmacist||
2233|232|R|or local waste disposal company.||
2233|233|B|||
2233|234|M|MEDICAL ALERT:  Your condition can cause complications in a||
2233|235|M|medical emergency. For information about enrolling in MedicAlert,||
2233|236|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2233|237|B|||
2233|238|A|Information last revised April 2025.||
2233|239|A|Copyright(c) 2025 First Databank, Inc.||
2233|240|B|||
2234|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2234|002|Z|does NOT have all possible information about this product. This||
2234|003|Z|information does not assure that this product is safe, effective,||
2234|004|Z|or appropriate for you. This information is not individual||
2234|005|Z|medical advice and does not substitute for the advice of your||
2234|006|Z|health care professional. Always ask your health care||
2234|007|Z|professional for complete information about this product and your||
2234|008|Z|specific health needs.||
2234|009|B|||
2234|010|T|LURBINECTEDIN - INJECTION||
2234|011|F|(LOOR-bin-EK-te-din)||
2234|012|B|||
2234|013|C|COMMON BRAND NAME(S): Zepzelca||
2234|014|B|||
2234|015|U|USES:  This medication is used to treat lung cancer.||
2234|016|U|Lurbinectedin belongs to a class of drugs known as alkylating||
2234|017|U|agents. It works by slowing or stopping the growth of cancer||
2234|018|U|cells.||
2234|019|B|||
2234|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2234|021|H|from your pharmacist before you start using lurbinectedin and||
2234|022|H|before each treatment. If you have any questions, ask your doctor||
2234|023|H|or pharmacist.||
2234|024|H|   This medication is given by injection into a vein as directed||
2234|025|H|by your doctor, usually every 21 days. The injection is given by||
2234|026|H|a health care professional, usually over 60 minutes.||
2234|027|H|   The dosage is based on your medical condition, body size,||
2234|028|H|response to treatment, lab tests, and other medications you may||
2234|029|H|be taking. Be sure to tell your doctor and pharmacist about all||
2234|030|H|the products you use (including prescription drugs,||
2234|031|H|nonprescription drugs, and herbal products).||
2234|032|H|   Your doctor may prescribe medications (such as dexamethasone,||
2234|033|H|ondansetron) before each dose to help prevent side effects such||
2234|034|H|as nausea/vomiting. Carefully follow your doctor's directions for||
2234|035|H|all your medications.||
2234|036|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2234|037|H|using this medication unless your doctor or pharmacist says you||
2234|038|H|may do so safely. Also avoid eating Seville oranges (often found||
2234|039|H|in marmalade). Grapefruit and Seville oranges can increase the||
2234|040|H|chance of side effects with this medicine. Ask your doctor or||
2234|041|H|pharmacist for more details.||
2234|042|H|   To get the most benefit, do not miss any doses. To help you||
2234|043|H|remember, mark your calendar with a reminder.||
2234|044|B|||
2234|045|S|SIDE EFFECTS:  Tiredness, joint pain, constipation or diarrhea,||
2234|046|S|abdominal pain, nausea, vomiting, or loss of appetite may occur.||
2234|047|S|Nausea and vomiting can be severe. In some cases, your doctor may||
2234|048|S|prescribe medication to prevent or relieve nausea and vomiting.||
2234|049|S|Eating several small meals, not eating before treatment, or||
2234|050|S|limiting activity may help lessen some of these effects. If any||
2234|051|S|of these effects last or get worse, tell your doctor or||
2234|052|S|pharmacist promptly.||
2234|053|S|   People using this medication may have serious side effects.||
2234|054|S|However, you have been prescribed this drug because your doctor||
2234|055|S|has judged that the benefit to you is greater than the risk of||
2234|056|S|side effects. Careful monitoring by your doctor may decrease your||
2234|057|S|risk.||
2234|058|S|   Tell your doctor right away if you have any serious side||
2234|059|S|effects, including: pain/redness/swelling at injection site, easy||
2234|060|S|bruising/bleeding, numbness/tingling/pain in the arms or legs,||
2234|061|S|pale skin, muscle pain/tenderness/weakness, signs of liver||
2234|062|S|problems (such as nausea/vomiting that doesn't stop, loss of||
2234|063|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2234|064|S|urine).||
2234|065|S|   This medication may lower your ability to fight infections.||
2234|066|S|This may make you more likely to get a serious (rarely fatal)||
2234|067|S|infection or make any infection you have worse. Tell your doctor||
2234|068|S|right away if you have any signs of infection (such as sore||
2234|069|S|throat that doesn't go away, fever, chills).||
2234|070|S|   A very serious allergic reaction to this drug is rare.||
2234|071|S|However, get medical help right away if you notice any symptoms||
2234|072|S|of a serious allergic reaction, including: rash, itching/swelling||
2234|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2234|074|S|breathing.||
2234|075|S|   This is not a complete list of possible side effects. If you||
2234|076|S|notice other effects not listed above, contact your doctor or||
2234|077|S|pharmacist.||
2234|078|S|   In the US -||
2234|079|S|   Call your doctor for medical advice about side effects. You||
2234|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2234|081|S|www.fda.gov/medwatch.||
2234|082|S|   In Canada - Call your doctor for medical advice about side||
2234|083|S|effects. You may report side effects to Health Canada at||
2234|084|S|1-866-234-2345.||
2234|085|B|||
2234|086|P|PRECAUTIONS:  Before receiving lurbinectedin, tell your doctor or||
2234|087|P|pharmacist if you are allergic to it; or if you have any other||
2234|088|P|allergies. This product may contain other inactive ingredients,||
2234|089|P|which can cause allergic reactions or other problems. Talk to||
2234|090|P|your pharmacist for more details.||
2234|091|P|   Before using this medication, tell your doctor or pharmacist||
2234|092|P|your medical history, especially of: recent/current infections,||
2234|093|P|kidney problems, liver problems.||
2234|094|P|   Lurbinectedin can make you more likely to get infections or||
2234|095|P|may make current infections worse. Stay away from anyone who has||
2234|096|P|an infection that may easily spread (such as chickenpox,||
2234|097|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2234|098|P|exposed to an infection or for more details.||
2234|099|P|   Tell your health care professional that you are using||
2234|100|P|lurbinectedin before having any immunizations/vaccinations. Avoid||
2234|101|P|contact with people who have recently received live vaccines||
2234|102|P|(such as flu vaccine inhaled through the nose).||
2234|103|P|   To lower the chance of getting cut, bruised, or injured, use||
2234|104|P|caution with sharp objects like razors and nail cutters, and||
2234|105|P|avoid activities such as contact sports.||
2234|106|P|   Before having surgery, tell your doctor or dentist about all||
2234|107|P|the products you use (including prescription drugs,||
2234|108|P|nonprescription drugs, and herbal products).||
2234|109|P|   Older adults may be at greater risk for low blood cell counts||
2234|110|P|while using this drug.||
2234|111|P|   Tell your doctor if you are pregnant or plan to become||
2234|112|P|pregnant. You should not become pregnant while using||
2234|113|P|lurbinectedin. Lurbinectedin may harm an unborn baby. Your doctor||
2234|114|P|should order a pregnancy test before you start this medication.||
2234|115|P|Women using this medication should ask about reliable forms of||
2234|116|P|birth control during treatment and for at least 6 months after||
2234|117|P|the last dose. Men using this medication should ask about||
2234|118|P|reliable forms of birth control during treatment and for at least||
2234|119|P|4 months after the last dose. If you or your partner becomes||
2234|120|P|pregnant, talk to your doctor right away about the risks and||
2234|121|P|benefits of this medication.||
2234|122|P|   It is unknown if this drug passes into breast milk. Because of||
2234|123|P|the possible risk to the infant, breastfeeding is not recommended||
2234|124|P|while using this drug and for at least 2 weeks after the last||
2234|125|P|dose. Consult your doctor before breastfeeding.||
2234|126|B|||
2234|127|I|DRUG INTERACTIONS:  See also How to Use section.||
2234|128|I|   Drug interactions may change how your medications work or||
2234|129|I|increase your risk for serious side effects. This document does||
2234|130|I|not contain all possible drug interactions. Keep a list of all||
2234|131|I|the products you use (including prescription/nonprescription||
2234|132|I|drugs and herbal products) and share it with your doctor and||
2234|133|I|pharmacist. Do not start, stop, or change the dosage of any||
2234|134|I|medicines without your doctor's approval.||
2234|135|I|   Other medications can affect the removal of lurbinectedin from||
2234|136|I|your body, which may affect how lurbinectedin works. Examples||
2234|137|I|include azole antifungals (such as itraconazole, ketoconazole),||
2234|138|I|macrolide antibiotics (such as clarithromycin), rifamycins (such||
2234|139|I|as rifabutin, rifampin), ritonavir, St. John's wort, some drugs||
2234|140|I|used to treat seizures (such as carbamazepine, phenobarbital,||
2234|141|I|primidone), among others.||
2234|142|B|||
2234|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2234|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2234|145|O|poison control center right away. US residents can call||
2234|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2234|147|B|||
2234|148|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2234|149|N|kidney/liver function, blood sugar, sodium/magnesium blood||
2234|150|N|levels, CPK levels) should be done before you start using this||
2234|151|N|medication and while you are using it. Keep all medical and lab||
2234|152|N|appointments.||
2234|153|B|||
2234|154|D|MISSED DOSE:  It is important to get each dose of this medication||
2234|155|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2234|156|D|right away for a new dosing schedule.||
2234|157|B|||
2234|158|R|STORAGE:  Not applicable. This medication is given in a hospital||
2234|159|R|or clinic and will not be stored at home.||
2234|160|B|||
2234|161|M|MEDICAL ALERT:  Your condition can cause complications in a||
2234|162|M|medical emergency. For information about enrolling in MedicAlert,||
2234|163|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2234|164|B|||
2234|165|A|Information last revised April 2025.||
2234|166|A|Copyright(c) 2025 First Databank, Inc.||
2234|167|B|||
2236|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2236|002|Z|does NOT have all possible information about this product. This||
2236|003|Z|information does not assure that this product is safe, effective,||
2236|004|Z|or appropriate for you. This information is not individual||
2236|005|Z|medical advice and does not substitute for the advice of your||
2236|006|Z|health care professional. Always ask your health care||
2236|007|Z|professional for complete information about this product and your||
2236|008|Z|specific health needs.||
2236|009|B|||
2236|010|T|INEBILIZUMAB - INJECTION||
2236|011|F|(in-EB-i-LIZ-ue-mab)||
2236|012|B|||
2236|013|C|COMMON BRAND NAME(S): Uplizna||
2236|014|B|||
2236|015|U|USES:  This medication is used to treat a certain nervous system||
2236|016|U|disorder that affects the eye (optic) nerve and spinal cord||
2236|017|U|(neuromyelitis optica spectrum disorder-NMOSD). Inebilizumab is||
2236|018|U|also used to treat a chronic immune condition (immunoglobulin G4||
2236|019|U|related disease-IgG4-RD). This medication belongs to a class of||
2236|020|U|drugs known as monoclonal antibodies. It may help reduce swelling||
2236|021|U|and decrease the risk of attacks.||
2236|022|B|||
2236|023|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2236|024|H|Patient Information Leaflet provided by your pharmacist before||
2236|025|H|you start receiving inebilizumab and each time you get a refill.||
2236|026|H|If you have any questions, ask your doctor or pharmacist.||
2236|027|H|   This medication is given by slow injection into a vein as||
2236|028|H|directed by your doctor. The injection is given by a health care||
2236|029|H|professional, usually over about 90 minutes. The first 2 doses||
2236|030|H|are usually given 2 weeks apart. Later doses are usually given||
2236|031|H|every 6 months.||
2236|032|H|   Infusion reactions or serious allergic reactions may happen||
2236|033|H|during or right after the infusion of this drug. Your doctor may||
2236|034|H|prescribe other medications (such as acetaminophen,||
2236|035|H|diphenhydramine, corticosteroids) before each treatment to help||
2236|036|H|prevent these side effects. Tell your doctor right away if you||
2236|037|H|have any symptoms of infusion or allergic reactions such as||
2236|038|H|nausea, fever, flushing, mild rash/itching, shortness of breath,||
2236|039|H|tiredness, headache, pounding heartbeat, or muscle aches. Your||
2236|040|H|doctor may give you other medications to help with these side||
2236|041|H|effects or may slow down or stop your treatment for some time.||
2236|042|H|   Tell your doctor if your condition does not get better or if||
2236|043|H|it gets worse.||
2236|044|B|||
2236|045|S|SIDE EFFECTS:  See also How to Use section.||
2236|046|S|   Joint pain, back pain, or headache may occur. If any of these||
2236|047|S|effects last or get worse, tell your doctor or pharmacist||
2236|048|S|promptly.||
2236|049|S|   Remember that this medication has been prescribed because your||
2236|050|S|doctor has judged that the benefit to you is greater than the||
2236|051|S|risk of side effects. Many people using this medication do not||
2236|052|S|have serious side effects.||
2236|053|S|   This medication may lower your ability to fight infections.||
2236|054|S|This may make you more likely to get a serious (rarely fatal)||
2236|055|S|infection or make any infection you have worse. Tell your doctor||
2236|056|S|right away if you have any signs of infection (such as sore||
2236|057|S|throat that doesn't go away, fever, chills, painful/frequent||
2236|058|S|urination).||
2236|059|S|   This medication may increase your risk of getting a rare but||
2236|060|S|very serious (possibly fatal) brain infection (progressive||
2236|061|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2236|062|S|if you have any of these side effects: clumsiness, loss of||
2236|063|S|coordination/balance, weakness, sudden change in your thinking||
2236|064|S|(such as confusion, difficulty concentrating, memory loss),||
2236|065|S|difficulty talking/walking, seizure, vision changes.||
2236|066|S|   A very serious allergic reaction to this drug is rare.||
2236|067|S|However, get medical help right away if you notice any symptoms||
2236|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2236|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2236|070|S|breathing.||
2236|071|S|   This is not a complete list of possible side effects. If you||
2236|072|S|notice other effects not listed above, contact your doctor or||
2236|073|S|pharmacist.||
2236|074|S|   In the US -||
2236|075|S|   Call your doctor for medical advice about side effects. You||
2236|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2236|077|S|www.fda.gov/medwatch.||
2236|078|S|   In Canada - Call your doctor for medical advice about side||
2236|079|S|effects. You may report side effects to Health Canada at||
2236|080|S|1-866-234-2345.||
2236|081|B|||
2236|082|P|PRECAUTIONS:  Before using inebilizumab, tell your doctor or||
2236|083|P|pharmacist if you are allergic to it; or if you have any other||
2236|084|P|allergies. This product may contain inactive ingredients, which||
2236|085|P|can cause allergic reactions or other problems. Talk to your||
2236|086|P|pharmacist for more details.||
2236|087|P|   Before using this medication, tell your doctor or pharmacist||
2236|088|P|your medical history, especially of: current/recent infection||
2236|089|P|(especially of hepatitis B).||
2236|090|P|   Inebilizumab can make you more likely to get infections or may||
2236|091|P|make current infections worse. Stay away from anyone who has an||
2236|092|P|infection that may easily spread (such as chickenpox, COVID-19,||
2236|093|P|measles, flu). Talk to your doctor if you have been exposed to an||
2236|094|P|infection or for more details.||
2236|095|P|   Tell your doctor your vaccine history and ask if you need to||
2236|096|P|get any vaccines before starting treatment with this medication.||
2236|097|P|Your doctor may direct you to have any required vaccines at least||
2236|098|P|4 weeks before starting this medication. Tell your health care||
2236|099|P|professional that you are using inebilizumab before having any||
2236|100|P|immunizations/vaccinations. Avoid contact with people who have||
2236|101|P|recently received live vaccines (such as flu vaccine inhaled||
2236|102|P|through the nose).||
2236|103|P|   Before having surgery, tell your doctor or dentist about all||
2236|104|P|the products you use (including prescription drugs,||
2236|105|P|nonprescription drugs, and herbal products).||
2236|106|P|   Tell your doctor if you are pregnant or plan to become||
2236|107|P|pregnant. You should not become pregnant while using||
2236|108|P|inebilizumab. Inebilizumab may harm an unborn baby. Ask about||
2236|109|P|reliable forms of birth control while using this medication and||
2236|110|P|for 6 months after the last dose. If you become pregnant, talk to||
2236|111|P|your doctor right away about the risks and benefits of this||
2236|112|P|medication.||
2236|113|P|   It is unknown if this medication passes into breast milk.||
2236|114|P|Consult your doctor before breastfeeding.||
2236|115|B|||
2236|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2236|117|I|medications work or increase your risk for serious side effects.||
2236|118|I|This document does not contain all possible drug interactions.||
2236|119|I|Keep a list of all the products you use (including||
2236|120|I|prescription/nonprescription drugs and herbal products) and share||
2236|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
2236|122|I|the dosage of any medicines without your doctor's approval.||
2236|123|I|   Some products that may interact with this drug are: other||
2236|124|I|drugs that weaken the immune system/increase the risk of||
2236|125|I|infection (such as natalizumab, rituximab).||
2236|126|B|||
2236|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2236|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2236|129|O|poison control center right away. US residents can call||
2236|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2236|131|B|||
2236|132|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2236|133|N|tests for hepatitis B) should be done before you start using this||
2236|134|N|medication and while you are using it. Keep all medical and lab||
2236|135|N|appointments.||
2236|136|B|||
2236|137|D|MISSED DOSE:  It is important to get each dose of this medication||
2236|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2236|139|D|right away for a new dosing schedule.||
2236|140|B|||
2236|141|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2236|142|R|hospital and will not be stored at home.||
2236|143|B|||
2236|144|M|MEDICAL ALERT:  Your condition can cause complications in a||
2236|145|M|medical emergency. For information about enrolling in MedicAlert,||
2236|146|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2236|147|B|||
2236|148|A|Information last revised April 2025.||
2236|149|A|Copyright(c) 2025 First Databank, Inc.||
2236|150|B|||
2237|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2237|002|Z|does NOT have all possible information about this product. This||
2237|003|Z|information does not assure that this product is safe, effective,||
2237|004|Z|or appropriate for you. This information is not individual||
2237|005|Z|medical advice and does not substitute for the advice of your||
2237|006|Z|health care professional. Always ask your health care||
2237|007|Z|professional for complete information about this product and your||
2237|008|Z|specific health needs.||
2237|009|B|||
2237|010|T|CAPMATINIB - ORAL||
2237|011|F|(kap-MA-ti-nib)||
2237|012|B|||
2237|013|C|COMMON BRAND NAME(S): Tabrecta||
2237|014|B|||
2237|015|U|USES:  This medication is used to treat a certain type of lung||
2237|016|U|cancer (non-small cell lung cancer-NSCLC). Capmatinib works by||
2237|017|U|slowing or stopping the growth of cancer cells. It belongs to a||
2237|018|U|class of drugs known as kinase inhibitors.||
2237|019|B|||
2237|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2237|021|H|from your pharmacist before you start using capmatinib and each||
2237|022|H|time you get a refill. If you have any questions, ask your doctor||
2237|023|H|or pharmacist.||
2237|024|H|   Take this medication by mouth with or without food as directed||
2237|025|H|by your doctor, usually twice daily. Swallow the tablets whole.||
2237|026|H|Do not crush, chew, or break the tablets.||
2237|027|H|   The dosage is based on your medical condition and response to||
2237|028|H|treatment. If you have certain side effects, your doctor may||
2237|029|H|adjust your dose or stop treatment for some time.||
2237|030|H|   Do not increase your dose or use this drug more often or for||
2237|031|H|longer than prescribed. Your condition will not improve any||
2237|032|H|faster, and your risk of serious side effects will increase.||
2237|033|H|   If you vomit your dose of capmatinib, do not take another||
2237|034|H|dose. Take your next dose at your regular scheduled time. Do not||
2237|035|H|take two doses at the same time.||
2237|036|H|   Take this medication regularly to get the most benefit from||
2237|037|H|it. To help you remember, take it at the same times each day.||
2237|038|H|   Since this drug can be absorbed through the skin and lungs and||
2237|039|H|may harm an unborn baby, women who are pregnant or who may become||
2237|040|H|pregnant should not handle this medication or breathe the dust||
2237|041|H|from the tablets.||
2237|042|B|||
2237|043|S|SIDE EFFECTS:  Swelling hands/ankles/feet, muscle/joint pain,||
2237|044|S|tiredness, fever, nausea/vomiting, decreased appetite, weight||
2237|045|S|loss, constipation, or diarrhea may occur. If any of these||
2237|046|S|effects last or get worse, tell your doctor or pharmacist||
2237|047|S|promptly.||
2237|048|S|   People using this medication may have serious side effects.||
2237|049|S|However, you have been prescribed this drug because your doctor||
2237|050|S|has judged that the benefit to you is greater than the risk of||
2237|051|S|side effects. Careful monitoring by your doctor may decrease your||
2237|052|S|risk.||
2237|053|S|   Tell your doctor right away if you have any serious side||
2237|054|S|effects, including: new or worsening lung problems (such as||
2237|055|S|shortness of breath, chest pain, cough), signs of liver or||
2237|056|S|pancreas problems (such as nausea/vomiting that doesn't stop,||
2237|057|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2237|058|S|   A very serious allergic reaction to this drug is rare.||
2237|059|S|However, get medical help right away if you notice any symptoms||
2237|060|S|of a serious allergic reaction, including: rash, itching/swelling||
2237|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2237|062|S|breathing.||
2237|063|S|   This is not a complete list of possible side effects. If you||
2237|064|S|notice other effects not listed above, contact your doctor or||
2237|065|S|pharmacist.||
2237|066|S|   In the US -||
2237|067|S|   Call your doctor for medical advice about side effects. You||
2237|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2237|069|S|www.fda.gov/medwatch.||
2237|070|S|   In Canada - Call your doctor for medical advice about side||
2237|071|S|effects. You may report side effects to Health Canada at||
2237|072|S|1-866-234-2345.||
2237|073|B|||
2237|074|P|PRECAUTIONS:  Before taking capmatinib, tell your doctor or||
2237|075|P|pharmacist if you are allergic to it; or if you have any other||
2237|076|P|allergies. This product may contain inactive ingredients, which||
2237|077|P|can cause allergic reactions or other problems. Talk to your||
2237|078|P|pharmacist for more details.||
2237|079|P|   Before using this medication, tell your doctor or pharmacist||
2237|080|P|your medical history, especially of: liver disease, lung||
2237|081|P|problems, disease of the pancreas (pancreatitis).||
2237|082|P|   Before having surgery, tell your doctor or dentist about all||
2237|083|P|the products you use (including prescription drugs,||
2237|084|P|nonprescription drugs, and herbal products).||
2237|085|P|   This medication may make you more sensitive to the sun. Limit||
2237|086|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2237|087|P|sunscreen and wear protective clothing when outdoors. Tell your||
2237|088|P|doctor right away if you get sunburned or have skin||
2237|089|P|blisters/redness. Ask your doctor for details.||
2237|090|P|   Since this drug can be absorbed through the skin and lungs and||
2237|091|P|may harm an unborn baby, women who are pregnant or who may become||
2237|092|P|pregnant should not handle this medication or breathe the dust||
2237|093|P|from the tablets.||
2237|094|P|   Tell your doctor if you are pregnant or plan to become||
2237|095|P|pregnant. You should not become pregnant while using capmatinib.||
2237|096|P|Capmatinib may harm an unborn baby. Your doctor should order a||
2237|097|P|pregnancy test before you start this medication. Men and women||
2237|098|P|using this medication should ask about reliable forms of birth||
2237|099|P|control during treatment and for 1 week after the last dose. If||
2237|100|P|you or your partner becomes pregnant, talk to your doctor right||
2237|101|P|away about the risks and benefits of this medication.||
2237|102|P|   It is unknown if this drug passes into breast milk. Because of||
2237|103|P|the possible risk to the infant, breastfeeding is not recommended||
2237|104|P|while using this drug and for 1 week after the last dose. Consult||
2237|105|P|your doctor before breastfeeding.||
2237|106|B|||
2237|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2237|108|I|medications work or increase your risk for serious side effects.||
2237|109|I|This document does not contain all possible drug interactions.||
2237|110|I|Keep a list of all the products you use (including||
2237|111|I|prescription/nonprescription drugs and herbal products) and share||
2237|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2237|113|I|the dosage of any medicines without your doctor's approval.||
2237|114|I|   A product that may interact with this drug is: fezolinetant.||
2237|115|I|   Other medications can affect the removal of capmatinib from||
2237|116|I|your body, which may affect how capmatinib works. Examples||
2237|117|I|include rifamycins (such as rifampin, rifabutin), drugs used to||
2237|118|I|treat seizures (such as phenytoin, carbamazepine), St. John's||
2237|119|I|wort, among others.||
2237|120|B|||
2237|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2237|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2237|123|O|poison control center right away. US residents can call||
2237|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2237|125|B|||
2237|126|N|NOTES:  Do not share this medication with others.||
2237|127|N|   Lab and/or medical tests (such as blood mineral levels,||
2237|128|N|liver/kidney function, complete blood counts, amylase/lipase||
2237|129|N|levels) should be done before you start taking this medication||
2237|130|N|and while you are taking it. Keep all medical and lab||
2237|131|N|appointments.||
2237|132|B|||
2237|133|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2237|134|D|next dose at the regular time. Do not double the dose to catch||
2237|135|D|up.||
2237|136|B|||
2237|137|R|STORAGE:  Store in the original container at room temperature||
2237|138|R|away from light and moisture. Do not store in the bathroom. Keep||
2237|139|R|the drying agent (desiccant) in the bottle. Tightly close the||
2237|140|R|bottle when not in use. Once the bottle is opened, this||
2237|141|R|medication expires after 6 weeks. Keep all medications away from||
2237|142|R|children and pets.||
2237|143|R|   Do not flush medications down the toilet or pour them into a||
2237|144|R|drain unless instructed to do so. Properly discard this product||
2237|145|R|when it is expired or no longer needed. Consult your pharmacist||
2237|146|R|or local waste disposal company.||
2237|147|B|||
2237|148|A|Information last revised July 2024.||
2237|149|A|Copyright(c) 2025 First Databank, Inc.||
2237|150|B|||
2239|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2239|002|Z|does NOT have all possible information about this product. This||
2239|003|Z|information does not assure that this product is safe, effective,||
2239|004|Z|or appropriate for you. This information is not individual||
2239|005|Z|medical advice and does not substitute for the advice of your||
2239|006|Z|health care professional. Always ask your health care||
2239|007|Z|professional for complete information about this product and your||
2239|008|Z|specific health needs.||
2239|009|B|||
2239|010|T|CODEINE - INJECTION||
2239|011|F|(KOE-deen)||
2239|012|B|||
2239|013|W|WARNING:  Codeine has a risk for abuse and addiction, which can||
2239|014|W|lead to overdose and death. Codeine may also cause severe,||
2239|015|W|possibly fatal, breathing problems. To lower your risk, your||
2239|016|W|doctor should have you use the smallest dose of codeine that||
2239|017|W|works, and use it for the shortest possible time. See also How to||
2239|018|W|Use section for more information about addiction.||
2239|019|W|   Ask your doctor or pharmacist if you should have medication||
2239|020|W|available to treat opioid overdose (such as naloxone, nalmefene).||
2239|021|W|Teach your family or household members about the signs of an||
2239|022|W|opioid overdose and how to treat it.||
2239|023|W|   The risk for severe breathing problems is higher when you||
2239|024|W|start this medication and after a dose increase, or if you use||
2239|025|W|the wrong dose/strength. Using this medication with alcohol or||
2239|026|W|other drugs that can cause drowsiness or breathing problems may||
2239|027|W|cause very serious side effects, including death. Also, other||
2239|028|W|medications can affect the removal of codeine from your body,||
2239|029|W|which may affect how codeine works. Be sure you know how to use||
2239|030|W|codeine and what other drugs you should avoid using with it. See||
2239|031|W|also Drug Interactions section. Get medical help right away if||
2239|032|W|any of these very serious side effects occur: slow/shallow||
2239|033|W|breathing, unusual lightheadedness, severe drowsiness/dizziness,||
2239|034|W|difficulty waking up.||
2239|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
2239|036|W|or abuse. If someone accidentally uses this drug, get medical||
2239|037|W|help right away.||
2239|038|W|   Before using this medication, women of childbearing age should||
2239|039|W|talk with their doctor(s) about the risks and benefits. Tell your||
2239|040|W|doctor if you are pregnant or if you plan to become pregnant.||
2239|041|W|During pregnancy, this medication should be used only when||
2239|042|W|clearly needed. It may slightly increase the risk of birth||
2239|043|W|defects if used during the first two months of pregnancy. Also,||
2239|044|W|using it for a long time or in high doses near the expected||
2239|045|W|delivery date may harm the unborn baby. To lessen the risk, use||
2239|046|W|the smallest effective dose for the shortest possible time.||
2239|047|W|Babies born to mothers who use this drug for a long time may||
2239|048|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
2239|049|W|doctor right away if you notice any symptoms in your newborn baby||
2239|050|W|such as crying that doesn't stop, slow/shallow breathing,||
2239|051|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
2239|052|W|difficulty gaining weight.||
2239|053|W|   Children younger than 18 years should not use products that||
2239|054|W|contain codeine. Some children are more sensitive to codeine and||
2239|055|W|have had very serious (rarely fatal) breathing problems such as||
2239|056|W|slow/shallow breathing (see also Side Effects section). The risk||
2239|057|W|is greater in children who are obese or have breathing problems,||
2239|058|W|or after certain surgeries (including tonsil/adenoid removal).||
2239|059|W|Talk with your doctor or pharmacist about the risks and benefits||
2239|060|W|of this medication.||
2239|061|B|||
2239|062|U|USES:  See also Warning section.||
2239|063|U|   This medication is used to treat mild to moderately severe||
2239|064|U|pain. Codeine is an opioid pain reliever. It acts on certain||
2239|065|U|centers in the brain to give you pain relief.||
2239|066|B|||
2239|067|H|HOW TO USE:  This medication is given by injection into a muscle||
2239|068|H|or under the skin as directed by your doctor. If you have nausea||
2239|069|H|after using this medication, ask your doctor or pharmacist about||
2239|070|H|ways to decrease it (such as lying down for 1 to 2 hours with as||
2239|071|H|little head movement as possible).||
2239|072|H|   The dosage is based on your medical condition and response to||
2239|073|H|treatment. Do not increase your dose, use the medication more||
2239|074|H|often, or use it for a longer time than prescribed. Properly stop||
2239|075|H|the medication when so directed.||
2239|076|H|   If you are using this medication at home, learn all||
2239|077|H|preparation and usage instructions from your health care||
2239|078|H|professional. Before using, check this product for particles or||
2239|079|H|discoloration. If either is present, do not use the liquid.||
2239|080|H|Before injecting each dose, clean the skin you are going to||
2239|081|H|inject into (the injection site) with rubbing alcohol. Change the||
2239|082|H|injection site each time to lessen injury under the skin. Learn||
2239|083|H|how to store and discard medical supplies safely.||
2239|084|H|   Pain medications work best if they are used as the first signs||
2239|085|H|of pain occur. If you wait until the pain has worsened, the||
2239|086|H|medication may not work as well.||
2239|087|H|   If you have ongoing pain (such as due to cancer), your doctor||
2239|088|H|may direct you to also take long-acting opioid medications. In||
2239|089|H|that case, this medication might be used for sudden||
2239|090|H|(breakthrough) pain only as needed. Other pain relievers (such as||
2239|091|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
2239|092|H|or pharmacist about using codeine safely with other drugs.||
2239|093|H|   Suddenly stopping this medication may cause withdrawal,||
2239|094|H|especially if you have used it for a long time or in high doses.||
2239|095|H|To prevent withdrawal, your doctor may lower your dose slowly.||
2239|096|H|Tell your doctor or pharmacist right away if you have any||
2239|097|H|withdrawal symptoms such as restlessness, mental/mood changes||
2239|098|H|(including anxiety, trouble sleeping, thoughts of suicide),||
2239|099|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
2239|100|H|aches, or sudden changes in behavior.||
2239|101|H|   When this medication is used for a long time, it may not work||
2239|102|H|as well. Talk with your doctor if this medication stops working||
2239|103|H|well.||
2239|104|H|   Though it helps many people, this medication may sometimes||
2239|105|H|cause addiction. This risk may be higher if you have a||
2239|106|H|mental/mood disorder or a substance use disorder (such as overuse||
2239|107|H|of or addiction to drugs/alcohol). Use this medication exactly as||
2239|108|H|prescribed to lower the risk of addiction. Ask your doctor or||
2239|109|H|pharmacist for more details.||
2239|110|H|   Tell your doctor if your pain does not get better or if it||
2239|111|H|gets worse, or if you have any new pain.||
2239|112|B|||
2239|113|S|SIDE EFFECTS:  See also Warning section.||
2239|114|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
2239|115|S|drowsiness may occur. Pain, redness, or swelling at the injection||
2239|116|S|site may also occur. If any of these effects last or get worse,||
2239|117|S|tell your doctor or pharmacist promptly.||
2239|118|S|   To prevent constipation, eat dietary fiber, drink enough||
2239|119|S|water, and exercise. You may also need to take a laxative. Ask||
2239|120|S|your pharmacist which type of laxative is right for you.||
2239|121|S|   To reduce the risk of dizziness and lightheadedness, get up||
2239|122|S|slowly when rising from a sitting or lying position.||
2239|123|S|   Remember that this medication has been prescribed because your||
2239|124|S|doctor has judged that the benefit to you is greater than the||
2239|125|S|risk of side effects. Many people using this medication do not||
2239|126|S|have serious side effects.||
2239|127|S|   Tell your doctor right away if you have any serious side||
2239|128|S|effects, including: interrupted breathing during sleep (sleep||
2239|129|S|apnea), mental/mood changes (such as agitation, depression,||
2239|130|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
2239|131|S|fast/slow heartbeat, vision changes, signs of your adrenal glands||
2239|132|S|not working well (such as loss of appetite, unusual tiredness,||
2239|133|S|weight loss), trouble swallowing.||
2239|134|S|   Get medical help right away if you have any very serious side||
2239|135|S|effects, including: fainting, seizure.||
2239|136|S|   Codeine is changed into a strong opioid drug (morphine) in||
2239|137|S|your body. In some people, this change happens faster and more||
2239|138|S|completely than usual, which increases the risk of very serious||
2239|139|S|side effects. Get medical help right away if you notice any of||
2239|140|S|the following: slow/shallow breathing, severe||
2239|141|S|drowsiness/difficulty waking up, confusion.||
2239|142|S|   A very serious allergic reaction to this drug is rare.||
2239|143|S|However, get medical help right away if you notice any symptoms||
2239|144|S|of a serious allergic reaction, including: rash, itching/swelling||
2239|145|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2239|146|S|breathing.||
2239|147|S|   This is not a complete list of possible side effects. If you||
2239|148|S|notice other effects not listed above, contact your doctor or||
2239|149|S|pharmacist.||
2239|150|S|   In the US -||
2239|151|S|   Call your doctor for medical advice about side effects. You||
2239|152|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2239|153|S|www.fda.gov/medwatch.||
2239|154|S|   In Canada - Call your doctor for medical advice about side||
2239|155|S|effects. You may report side effects to Health Canada at||
2239|156|S|1-866-234-2345.||
2239|157|B|||
2239|158|P|PRECAUTIONS:  Before using codeine, tell your doctor or||
2239|159|P|pharmacist if you are allergic to it; or to other opioid pain||
2239|160|P|medications (such as morphine); or if you have any other||
2239|161|P|allergies. This product may contain inactive ingredients, which||
2239|162|P|can cause allergic reactions or other problems. Talk to your||
2239|163|P|pharmacist for more details.||
2239|164|P|   Before using this medication, tell your doctor or pharmacist||
2239|165|P|your medical history, especially of: brain disorders (such as||
2239|166|P|head injury, tumor, seizures), breathing problems (such as||
2239|167|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
2239|168|P|gallbladder disease, kidney disease, liver disease, mental/mood||
2239|169|P|disorders (such as confusion, depression, thoughts of suicide),||
2239|170|P|personal or family history of a substance use disorder (such as||
2239|171|P|overuse of or addiction to drugs/alcohol), obesity,||
2239|172|P|stomach/intestinal problems (such as blockage, constipation,||
2239|173|P|diarrhea due to infection, paralytic ileus), disease of the||
2239|174|P|pancreas (pancreatitis), difficulty urinating (such as due to||
2239|175|P|enlarged prostate).||
2239|176|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2239|177|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2239|178|P|machinery, or do anything that needs alertness until you can do||
2239|179|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2239|180|P|are using marijuana (cannabis).||
2239|181|P|   Before having surgery, tell your doctor or dentist about all||
2239|182|P|the products you use (including prescription drugs,||
2239|183|P|nonprescription drugs, and herbal products).||
2239|184|P|   Older adults may be more sensitive to the side effects of this||
2239|185|P|drug, especially confusion, dizziness, drowsiness, and||
2239|186|P|slow/shallow breathing.||
2239|187|P|   During pregnancy, this medication should be used only when||
2239|188|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2239|189|P|benefits with your doctor. (See also Warning section.)||
2239|190|P|   This medication passes into breast milk and may have||
2239|191|P|undesirable effects on a nursing infant, such as unusual||
2239|192|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
2239|193|P|limpness. Consult your doctor before breastfeeding.||
2239|194|B|||
2239|195|I|DRUG INTERACTIONS:  See also Warning section.||
2239|196|I|   Drug interactions may change how your medications work or||
2239|197|I|increase your risk for serious side effects. This document does||
2239|198|I|not contain all possible drug interactions. Keep a list of all||
2239|199|I|the products you use (including prescription/nonprescription||
2239|200|I|drugs and herbal products) and share it with your doctor and||
2239|201|I|pharmacist. Do not start, stop, or change the dosage of any||
2239|202|I|medicines without your doctor's approval.||
2239|203|I|   Some products that may interact with this drug include:||
2239|204|I|certain pain medications (mixed opioid agonists-antagonists such||
2239|205|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
2239|206|I|samidorphan.||
2239|207|I|   The risk of serious side effects (such as slow/shallow||
2239|208|I|breathing, severe drowsiness/dizziness) may be increased if this||
2239|209|I|medication is taken with other products that may also cause||
2239|210|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2239|211|I|if you are taking other products such as other opioid pain or||
2239|212|I|cough relievers (such as morphine, hydrocodone), alcohol,||
2239|213|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
2239|214|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2239|215|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2239|216|I|cetirizine, diphenhydramine).||
2239|217|I|   Check the labels on all your medicines (such as allergy or||
2239|218|I|cough-and-cold products) because they may contain ingredients||
2239|219|I|that cause drowsiness. Ask your pharmacist about using those||
2239|220|I|products safely.||
2239|221|I|   Other medications can affect the removal of codeine from your||
2239|222|I|body, which may affect how codeine works. Examples include azole||
2239|223|I|antifungals (such as ketoconazole), bupropion, fluoxetine,||
2239|224|I|macrolide antibiotics (such as erythromycin), paroxetine,||
2239|225|I|quinidine, rifamycins (such as rifabutin, rifampin), ritonavir,||
2239|226|I|certain drugs used to treat seizures (such as carbamazepine,||
2239|227|I|phenytoin), among others.||
2239|228|I|   This medication may interfere with certain lab tests (such as||
2239|229|I|amylase/lipase levels), possibly causing false test results. Make||
2239|230|I|sure lab personnel and all your doctors know you use this drug.||
2239|231|B|||
2239|232|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2239|233|O|as passing out or trouble breathing, give them naloxone or||
2239|234|O|nalmefene if available, then call 911. If the person is awake and||
2239|235|O|has no symptoms, call a poison control center right away. US||
2239|236|O|residents can call 1-800-222-1222. Canada residents can call||
2239|237|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
2239|238|O|breathing, slow heartbeat, severe drowsiness, coma.||
2239|239|B|||
2239|240|N|NOTES:  Do not share this medication with others. Sharing it is||
2239|241|N|against the law.||
2239|242|N|   This medication has been prescribed for your current condition||
2239|243|N|only. Do not use it later for another condition unless told to do||
2239|244|N|so by your doctor. A different medication may be necessary in||
2239|245|N|that case.||
2239|246|B|||
2239|247|D|MISSED DOSE:  If you are using this medication on a regular||
2239|248|D|schedule and you miss a dose, use it as soon as you remember. If||
2239|249|D|it is near the time of the next dose, skip the missed dose. Use||
2239|250|D|your next dose at the regular time. Do not double the dose to||
2239|251|D|catch up.||
2239|252|B|||
2239|253|R|STORAGE:  Store at room temperature. Different brands of this||
2239|254|R|medication have different storage needs. Check the product||
2239|255|R|package for instructions on how to store your brand, or ask your||
2239|256|R|pharmacist. Keep all medications away from children and pets.||
2239|257|R|   Do not flush medications down the toilet or pour them into a||
2239|258|R|drain unless instructed to do so. Properly discard this product||
2239|259|R|when it is expired or no longer needed. Consult your pharmacist||
2239|260|R|or local waste disposal company.||
2239|261|B|||
2239|262|A|Information last revised August 2025.||
2239|263|A|Copyright(c) 2025 First Databank, Inc.||
2239|264|B|||
2240|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2240|002|Z|does NOT have all possible information about this product. This||
2240|003|Z|information does not assure that this product is safe, effective,||
2240|004|Z|or appropriate for you. This information is not individual||
2240|005|Z|medical advice and does not substitute for the advice of your||
2240|006|Z|health care professional. Always ask your health care||
2240|007|Z|professional for complete information about this product and your||
2240|008|Z|specific health needs.||
2240|009|B|||
2240|010|T|PENICILLIN G BENZATHINE - INJECTION||
2240|011|F|(PEN-i-SIL-in BEN-za-theen)||
2240|012|B|||
2240|013|C|COMMON BRAND NAME(S): Bicillin L-A||
2240|014|B|||
2240|015|W|WARNING:  This medication must not be injected into a vein or||
2240|016|W|mixed with solutions that will be injected into a vein because||
2240|017|W|serious (possibly fatal) side effects can occur.||
2240|018|B|||
2240|019|U|USES:  Penicillin G benzathine is used to treat a wide variety of||
2240|020|U|bacterial infections. It may also be used to prevent certain||
2240|021|U|bacterial infections (such as rheumatic fever). This medication||
2240|022|U|is a long-acting penicillin antibiotic. It works by stopping the||
2240|023|U|growth of bacteria.||
2240|024|B|||
2240|025|H|HOW TO USE:  This medication is given by injection into a large||
2240|026|H|muscle as directed by your doctor. The dosage is based on your||
2240|027|H|medical condition and response to treatment. Children's dosage is||
2240|028|H|also based on age and weight.||
2240|029|H|   If you are using this medication at home, learn all||
2240|030|H|preparation and usage instructions from your health care||
2240|031|H|professional. Do not inject into or near an artery, nerve, or||
2240|032|H|vein. See also Warning section. Change the injection site each||
2240|033|H|time to lessen injury to the muscle. Before using, check this||
2240|034|H|product for particles or discoloration. If either is present, do||
2240|035|H|not use the liquid. Learn how to store and discard medical||
2240|036|H|supplies safely.||
2240|037|H|   For the best effect, follow your doctor's directions for when||
2240|038|H|to receive this antibiotic, and make sure to not miss any doses.||
2240|039|H|   Continue to receive this medication for the full time||
2240|040|H|prescribed, even if symptoms disappear after a few days. Stopping||
2240|041|H|the medication too early may result in a return of the infection.||
2240|042|H|   Tell your doctor if your condition lasts or gets worse.||
2240|043|B|||
2240|044|S|SIDE EFFECTS:  Pain at the injection site, nausea, or vomiting||
2240|045|S|may occur. If any of these effects last or get worse, tell your||
2240|046|S|doctor or pharmacist promptly.||
2240|047|S|   Remember that this medication has been prescribed because your||
2240|048|S|doctor has judged that the benefit to you is greater than the||
2240|049|S|risk of side effects. Many people using this medication do not||
2240|050|S|have serious side effects.||
2240|051|S|   Tell your doctor right away if you have any serious side||
2240|052|S|effects, including: joint/muscle pain, vision changes, signs of a||
2240|053|S|new infection (such as sore throat that doesn't go away, fever,||
2240|054|S|chills), easy bruising/bleeding, unusual tiredness, mental/mood||
2240|055|S|changes (such as confusion, hallucinations, depression,||
2240|056|S|agitation).||
2240|057|S|   This medication may rarely cause a severe intestinal condition||
2240|058|S|due to a bacteria called C. difficile. This condition may occur||
2240|059|S|during treatment or weeks to months after treatment has stopped.||
2240|060|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2240|061|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2240|062|S|stool.||
2240|063|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2240|064|S|products because they may make symptoms worse.||
2240|065|S|   Use of this medication for prolonged or repeated periods may||
2240|066|S|result in oral thrush or a new yeast infection. Contact your||
2240|067|S|doctor if you notice white patches in your mouth, a change in||
2240|068|S|vaginal discharge, or other new symptoms.||
2240|069|S|   When used to treat syphilis and certain other infections, this||
2240|070|S|medication may cause a reaction that occurs several hours after||
2240|071|S|starting treatment and can last up to 24 hours. Tell your doctor||
2240|072|S|right away if you have any of these symptoms: headache,||
2240|073|S|fever/chills, sweating, joint/muscle pain, fast heartbeat,||
2240|074|S|dizziness, worsening of skin sores or other disease symptoms.||
2240|075|S|   Get medical help right away if you have any very serious side||
2240|076|S|effects, including: pain/redness/swelling/numbness/weakness of||
2240|077|S|arms/legs, change in skin color near the injection site or on||
2240|078|S|arms/legs, severe pain/peeling skin at the injection site, muscle||
2240|079|S|cramps/weakness around the injection site, inability to move||
2240|080|S|(paralysis), chest pain, swollen lymph nodes, severe||
2240|081|S|stomach/abdominal pain, nausea/vomiting that doesn't stop,||
2240|082|S|yellowing eyes/skin, irregular heartbeat, seizures,||
2240|083|S|pink/bloody/dark urine, signs of kidney problems (such as a||
2240|084|S|change in the amount of urine).||
2240|085|S|   A very serious allergic reaction to this drug is rare.||
2240|086|S|However, get medical help right away if you notice any symptoms||
2240|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2240|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2240|089|S|breathing.||
2240|090|S|   This is not a complete list of possible side effects. If you||
2240|091|S|notice other effects not listed above, contact your doctor or||
2240|092|S|pharmacist.||
2240|093|S|   In the US -||
2240|094|S|   Call your doctor for medical advice about side effects. You||
2240|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2240|096|S|www.fda.gov/medwatch.||
2240|097|S|   In Canada - Call your doctor for medical advice about side||
2240|098|S|effects. You may report side effects to Health Canada at||
2240|099|S|1-866-234-2345.||
2240|100|B|||
2240|101|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2240|102|P|pharmacist if you are allergic to it; or to other antibiotics||
2240|103|P|(such as other penicillins, cephalosporins); or if you have any||
2240|104|P|other allergies. This product may contain inactive ingredients,||
2240|105|P|which can cause allergic reactions or other problems. Talk to||
2240|106|P|your pharmacist for more details.||
2240|107|P|   Before using this medication, tell your doctor or pharmacist||
2240|108|P|your medical history, especially of: kidney disease.||
2240|109|P|   This medication may cause live bacterial vaccines (such as||
2240|110|P|typhoid vaccine) to not work well. Tell your health care||
2240|111|P|professional that you are using this medication before having any||
2240|112|P|immunizations/vaccinations.||
2240|113|P|   Before having surgery, tell your doctor or dentist about all||
2240|114|P|the products you use (including prescription drugs,||
2240|115|P|nonprescription drugs, and herbal products).||
2240|116|P|   During pregnancy, this medication should be used only when||
2240|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
2240|118|P|   This drug passes into breast milk in small amounts. Consult||
2240|119|P|your doctor before breastfeeding.||
2240|120|B|||
2240|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2240|122|I|medications work or increase your risk for serious side effects.||
2240|123|I|This document does not contain all possible drug interactions.||
2240|124|I|Keep a list of all the products you use (including||
2240|125|I|prescription/nonprescription drugs and herbal products) and share||
2240|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
2240|127|I|the dosage of any medicines without your doctor's approval.||
2240|128|I|   A product that may interact with this drug is: methotrexate.||
2240|129|I|   This medication may interfere with certain lab tests||
2240|130|I|(including certain urine glucose tests), possibly causing false||
2240|131|I|test results. Make sure lab personnel and all your doctors know||
2240|132|I|you use this drug.||
2240|133|B|||
2240|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2240|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2240|136|O|poison control center right away. US residents can call||
2240|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2240|138|O|Symptoms of overdose may include: seizures.||
2240|139|B|||
2240|140|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2240|141|N|kidney function, blood cultures) may be done if you are using||
2240|142|N|this medication for a long time. Keep all medical and lab||
2240|143|N|appointments.||
2240|144|B|||
2240|145|D|MISSED DOSE:  It is important to get each dose of this medication||
2240|146|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2240|147|D|right away for a new dosing schedule. Do not double the dose to||
2240|148|D|catch up.||
2240|149|B|||
2240|150|R|STORAGE:  Store in the refrigerator or as directed by your||
2240|151|R|pharmacist. Do not freeze. Keep all medications away from||
2240|152|R|children and pets.||
2240|153|R|   Do not flush medications down the toilet or pour them into a||
2240|154|R|drain unless instructed to do so. Properly discard this product||
2240|155|R|when it is expired or no longer needed. Consult your pharmacist||
2240|156|R|or local waste disposal company.||
2240|157|B|||
2240|158|A|Information last revised January 2025.||
2240|159|A|Copyright(c) 2025 First Databank, Inc.||
2240|160|B|||
2242|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2242|002|Z|does NOT have all possible information about this product. This||
2242|003|Z|information does not assure that this product is safe, effective,||
2242|004|Z|or appropriate for you. This information is not individual||
2242|005|Z|medical advice and does not substitute for the advice of your||
2242|006|Z|health care professional. Always ask your health care||
2242|007|Z|professional for complete information about this product and your||
2242|008|Z|specific health needs.||
2242|009|B|||
2242|010|T|LEVONORGESTREL/ETHINYL ESTRADIOL PATCH - TRANSDERMAL||
2242|011|F|(LEE-voe-nor-JES-trel/ETH-i-nil ES-tra-DYE-ol)||
2242|012|B|||
2242|013|C|COMMON BRAND NAME(S): Twirla||
2242|014|B|||
2242|015|W|WARNING:  Smoking raises your risk of stroke, heart attack, blood||
2242|016|W|clots, and high blood pressure from hormonal birth control (such||
2242|017|W|as the pill, patch, ring). The risk of these serious problems is||
2242|018|W|higher if you are obese and increases with age and with the||
2242|019|W|number of cigarettes you smoke. Do not use this medication if you||
2242|020|W|are obese, or if you smoke cigarettes/use tobacco and are over 35||
2242|021|W|years old.||
2242|022|B|||
2242|023|U|USES:  This patch contains combination hormone medication and is||
2242|024|U|used to prevent pregnancy. It contains 2 hormones: a progestin||
2242|025|U|(levonorgestrel) and an estrogen (ethinyl estradiol).||
2242|026|U|   Besides preventing pregnancy, birth control may make your||
2242|027|U|periods more regular, decrease blood loss and painful periods,||
2242|028|U|and decrease your risk of ovarian cysts.||
2242|029|U|   This product does not protect against sexually transmitted||
2242|030|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
2242|031|U|an effective barrier method (latex or polyurethane condom/dental||
2242|032|U|dams) during sexual activity will help to decrease your risk of||
2242|033|U|infection.||
2242|034|B|||
2242|035|H|HOW TO USE:  Read the Patient Information Leaflet and||
2242|036|H|Instructions for Use provided by your pharmacist before you start||
2242|037|H|using this medication and each time you get a refill. The leaflet||
2242|038|H|contains very important information on how to properly use and||
2242|039|H|dispose of the patch. If you have any questions, ask your doctor||
2242|040|H|or pharmacist.||
2242|041|H|   Do not cut or damage the patch. Remove the patch from the||
2242|042|H|pouch and apply as directed by the manufacturer to clean, dry||
2242|043|H|skin on the abdomen, buttock, or upper body where it will not be||
2242|044|H|rubbed by tight clothing. Do not apply the patch to your breasts||
2242|045|H|or on red/cut/irritated skin. Do not use lotions, creams, oils,||
2242|046|H|powders, or other products at the patch site, since the patch may||
2242|047|H|not stick properly or may fall off. Check your patch after||
2242|048|H|swimming or contact with water for long periods of time (30||
2242|049|H|minutes or more), since these may also affect how well the patch||
2242|050|H|sticks to your skin.||
2242|051|H|   If this is your first time using this medication, apply the||
2242|052|H|patch during the first 24 hours of your menstrual period. If you||
2242|053|H|start after day 1 of your menstrual period, use a backup form of||
2242|054|H|non-hormonal birth control (such as condoms, spermicide) for the||
2242|055|H|first 7 days to prevent pregnancy until the medication has enough||
2242|056|H|time to work. If you start using the patch on the first day of||
2242|057|H|your period, you do not need to use backup birth control the||
2242|058|H|first week.||
2242|059|H|   Change the patch once a week on the same day. Remove the used||
2242|060|H|patch before placing a new one. Apply the patch to a different||
2242|061|H|area with each change to avoid skin irritation. After wearing||
2242|062|H|patches for 3 weeks in a row, do not wear a patch during week 4.||
2242|063|H|You should have your period during this time. After not wearing a||
2242|064|H|patch for a week, apply a new patch whether or not you have your||
2242|065|H|period. If you do not get your period, consult your doctor. Do||
2242|066|H|not go longer than 7 days without a patch, since this will||
2242|067|H|increase your chance of pregnancy. To help you remember, mark||
2242|068|H|your calendar to remind yourself when to change or leave off||
2242|069|H|patches.||
2242|070|H|   If the patch falls off, re-apply it or apply a new patch||
2242|071|H|within 24 hours. If the patch is not replaced within 24 hours, or||
2242|072|H|if you are not sure how long it has been off, start a new cycle||
2242|073|H|by applying a new patch and use a backup form of non-hormonal||
2242|074|H|birth control (such as condoms, spermicide) for the next 7 days||
2242|075|H|to prevent pregnancy.||
2242|076|H|   After removing each patch, fold it in half so it sticks to||
2242|077|H|itself, and discard in the trash away from children and pets. Do||
2242|078|H|not flush the patch down the toilet.||
2242|079|H|   Ask your doctor or pharmacist for information about how to||
2242|080|H|switch from other forms of hormonal birth control (such as patch,||
2242|081|H|ring, birth control pills) to this product. If any information is||
2242|082|H|unclear, consult the Patient Information Leaflet/Medication Guide||
2242|083|H|or your doctor or pharmacist.||
2242|084|B|||
2242|085|S|SIDE EFFECTS:  Skin irritation at the application site, nausea,||
2242|086|S|vomiting, headache, bloating, breast tenderness, swelling of the||
2242|087|S|ankles/feet (fluid retention), or weight change may occur.||
2242|088|S|Vaginal bleeding between periods (spotting) or missed/irregular||
2242|089|S|periods may occur, especially during the first few months of use.||
2242|090|S|If any of these effects last or get worse, tell your doctor or||
2242|091|S|pharmacist promptly. If you miss 2 periods in a row (or 1 period||
2242|092|S|if the patch has not been used properly), talk to your doctor||
2242|093|S|about a pregnancy test.||
2242|094|S|   Remember that this medication has been prescribed because your||
2242|095|S|doctor has judged that the benefit to you is greater than the||
2242|096|S|risk of side effects. Many people using this medication do not||
2242|097|S|have serious side effects.||
2242|098|S|   This medication may raise your blood pressure. Check your||
2242|099|S|blood pressure regularly and tell your doctor if the results are||
2242|100|S|high.||
2242|101|S|   Tell your doctor right away if you have any serious side||
2242|102|S|effects, including: lumps in the breast, mental/mood changes||
2242|103|S|(such as new/worsening depression), unusual changes in vaginal||
2242|104|S|bleeding (such as continuous spotting, sudden heavy bleeding),||
2242|105|S|symptoms of high blood sugar (such as increased||
2242|106|S|thirst/urination), signs of liver problems (such as||
2242|107|S|nausea/vomiting that doesn't stop, loss of appetite,||
2242|108|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2242|109|S|   This medication may rarely cause serious (sometimes fatal)||
2242|110|S|problems from blood clots (such as heart attack, stroke, blood||
2242|111|S|clots in the lungs or legs). Get medical help right away if you||
2242|112|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
2242|113|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
2242|114|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2242|115|S|trouble speaking, weakness on one side of the body, sudden vision||
2242|116|S|changes.||
2242|117|S|   A very serious allergic reaction to this drug is rare.||
2242|118|S|However, get medical help right away if you notice any symptoms||
2242|119|S|of a serious allergic reaction, including: rash, itching/swelling||
2242|120|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2242|121|S|breathing.||
2242|122|S|   This is not a complete list of possible side effects. If you||
2242|123|S|notice other effects not listed above, contact your doctor or||
2242|124|S|pharmacist.||
2242|125|S|   In the US -||
2242|126|S|   Call your doctor for medical advice about side effects. You||
2242|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2242|128|S|www.fda.gov/medwatch.||
2242|129|S|   In Canada - Call your doctor for medical advice about side||
2242|130|S|effects. You may report side effects to Health Canada at||
2242|131|S|1-866-234-2345.||
2242|132|B|||
2242|133|P|PRECAUTIONS:  See also Warning section.||
2242|134|P|   Before using this medication patch, tell your doctor or||
2242|135|P|pharmacist if you are allergic to ethinyl estradiol or||
2242|136|P|levonorgestrel; or to other estrogens or progestins; or if you||
2242|137|P|have any other allergies. This product may contain inactive||
2242|138|P|ingredients, which can cause allergic reactions or other||
2242|139|P|problems. Talk to your pharmacist for more details.||
2242|140|P|   Before using this medication, tell your doctor or pharmacist||
2242|141|P|your medical history, especially of: blood clots (for example, in||
2242|142|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
2242|143|P|C or protein S deficiency), high blood pressure, abnormal breast||
2242|144|P|exam, cancer (especially endometrial or breast cancer), high||
2242|145|P|cholesterol or triglyceride (blood fat) levels, depression,||
2242|146|P|diabetes, family or personal history of a certain swelling||
2242|147|P|disorder (angioedema), gallbladder problems, severe||
2242|148|P|headaches/migraines, heart problems (such as heart valve disease,||
2242|149|P|irregular heartbeat, previous heart attack), history of yellowing||
2242|150|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
2242|151|P|birth control (such as pills, patch), liver disease (including||
2242|152|P|tumors), stroke, swelling (edema), thyroid problems, unexplained||
2242|153|P|vaginal bleeding.||
2242|154|P|   If you have diabetes, this medication may affect your blood||
2242|155|P|sugar. Check your blood sugar regularly as directed and share the||
2242|156|P|results with your doctor. Tell your doctor right away if you have||
2242|157|P|symptoms of high blood sugar such as increased thirst/urination.||
2242|158|P|Your doctor may need to adjust your diabetes medication, exercise||
2242|159|P|program, or diet.||
2242|160|P|   Tell your doctor if you just had or will be having surgery or||
2242|161|P|if you will be confined to a bed or chair for a long time (such||
2242|162|P|as a long plane flight). These conditions increase your risk of||
2242|163|P|getting blood clots, especially if you are using hormonal birth||
2242|164|P|control. You may need to stop this medication for a time or take||
2242|165|P|special precautions.||
2242|166|P|   This medication may cause blotchy, dark areas on your skin||
2242|167|P|(melasma). Sunlight may worsen this effect. Avoid prolonged sun||
2242|168|P|exposure, sunlamps, and tanning booths. Use a sunscreen, and wear||
2242|169|P|protective clothing when outdoors.||
2242|170|P|   If you are nearsighted or wear contact lenses, you may develop||
2242|171|P|vision problems or trouble wearing your contact lenses. Contact||
2242|172|P|your eye doctor if these problems occur.||
2242|173|P|   If you are going to have an MRI test, tell testing personnel||
2242|174|P|that you are using this patch. Some patches may contain metals||
2242|175|P|that can cause serious burns during an MRI. Ask your doctor||
2242|176|P|whether you will need to remove your patch before the test and||
2242|177|P|apply a new patch afterward, and how to do so properly.||
2242|178|P|   This medication must not be used during pregnancy. If you||
2242|179|P|become pregnant or think you may be pregnant, tell your doctor||
2242|180|P|right away. If you have just given birth or had a pregnancy loss||
2242|181|P|or abortion after the first 3 months, talk with your doctor about||
2242|182|P|reliable forms of birth control, and find out when it is safe to||
2242|183|P|start using birth control that contains a form of estrogen, such||
2242|184|P|as this medication.||
2242|185|P|   A small amount of this medication passes into breast milk and||
2242|186|P|may have undesirable effects on a nursing infant. Consult your||
2242|187|P|doctor before breastfeeding.||
2242|188|B|||
2242|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2242|190|I|medications work or increase your risk for serious side effects.||
2242|191|I|This document does not contain all possible drug interactions.||
2242|192|I|Keep a list of all the products you use (including||
2242|193|I|prescription/nonprescription drugs and herbal products) and share||
2242|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
2242|195|I|the dosage of any medicines without your doctor's approval.||
2242|196|I|   Some products that may interact with this drug are: aromatase||
2242|197|I|inhibitors (such as anastrozole, exemestane), fezolinetant,||
2242|198|I|ospemifene, tamoxifen, tizanidine, tranexamic acid.||
2242|199|I|   Some drugs may cause hormonal birth control to work less well||
2242|200|I|by decreasing the amount of birth control hormones in your body.||
2242|201|I|This effect can result in pregnancy. Examples include||
2242|202|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
2242|203|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
2242|204|I|seizures (such as barbiturates, carbamazepine, felbamate,||
2242|205|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
2242|206|I|nevirapine), among others.||
2242|207|I|   Tell your doctor when you start any new drug, and discuss if||
2242|208|I|you should use reliable backup birth control. Also tell your||
2242|209|I|doctor if you have any new spotting or breakthrough bleeding,||
2242|210|I|because these may be signs that your birth control is not working||
2242|211|I|well.||
2242|212|I|   This medication may interfere with certain lab tests (such as||
2242|213|I|blood tests for clotting factors, thyroid), possibly causing||
2242|214|I|false test results. Make sure lab personnel and all your doctors||
2242|215|I|know you use this medication.||
2242|216|B|||
2242|217|O|OVERDOSE:  This medication patch may be harmful if chewed or||
2242|218|O|swallowed. If someone has overdosed, remove the patch if||
2242|219|O|possible. For serious symptoms such as passing out or trouble||
2242|220|O|breathing, call 911. Otherwise, call a poison control center||
2242|221|O|right away. US residents can call 1-800-222-1222. Canada||
2242|222|O|residents can call 1-844-764-7669.||
2242|223|B|||
2242|224|N|NOTES:  Do not share this medication with others.||
2242|225|N|   You should have regular complete physical exams including||
2242|226|N|blood pressure, breast exam, pelvic exam, and screening for||
2242|227|N|cervical cancer (Pap smear). Follow your doctor's instructions||
2242|228|N|for examining your breasts, and report any lumps right away. Keep||
2242|229|N|all medical and lab appointments. Consult your doctor for more||
2242|230|N|details.||
2242|231|B|||
2242|232|D|MISSED DOSE:  If the patch comes off or if you forget to remove||
2242|233|D|it at the proper time, refer to the product package information||
2242|234|D|or How to Use section for instructions. You may need to use||
2242|235|D|backup birth control (such as condoms, spermicide) to prevent||
2242|236|D|pregnancy. Ask your doctor or pharmacist if you have any||
2242|237|D|questions.||
2242|238|D|   If you have trouble remembering to change your patch, or if||
2242|239|D|the patch often comes off, contact your doctor to discuss||
2242|240|D|switching to another form of birth control.||
2242|241|B|||
2242|242|R|STORAGE:  Store in the protective pouches at room temperature||
2242|243|R|away from light and moisture. Do not refrigerate or freeze. Keep||
2242|244|R|all medications away from children and pets.||
2242|245|R|   Do not flush medications down the toilet or pour them into a||
2242|246|R|drain unless instructed to do so. Properly discard this product||
2242|247|R|when it is expired or no longer needed. (See also How to Use||
2242|248|R|section.)||
2242|249|B|||
2242|250|A|Information last revised October 2025.||
2242|251|A|Copyright(c) 2025 First Databank, Inc.||
2242|252|B|||
2243|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2243|002|Z|does NOT have all possible information about this product. This||
2243|003|Z|information does not assure that this product is safe, effective,||
2243|004|Z|or appropriate for you. This information is not individual||
2243|005|Z|medical advice and does not substitute for the advice of your||
2243|006|Z|health care professional. Always ask your health care||
2243|007|Z|professional for complete information about this product and your||
2243|008|Z|specific health needs.||
2243|009|B|||
2243|010|T|FENFLURAMINE SOLUTION - ORAL||
2243|011|F|(fen-FLUR-a-meen)||
2243|012|B|||
2243|013|C|COMMON BRAND NAME(S): Fintepla||
2243|014|B|||
2243|015|W|WARNING:  Fenfluramine may cause heart valve problems (valvular||
2243|016|W|heart disease) and high blood pressure in the lungs (pulmonary||
2243|017|W|arterial hypertension). Medical tests (such as echocardiograms)||
2243|018|W|must be done before, during, and after treatment with this||
2243|019|W|medication. Tell your doctor right away if you have symptoms of||
2243|020|W|these serious side effects, including: shortness of breath, chest||
2243|021|W|pain, fast/irregular heartbeat, lightheadedness, fainting,||
2243|022|W|swelling ankles/feet.||
2243|023|W|   To receive fenfluramine in the United States, you must||
2243|024|W|understand, agree to, and carefully follow the requirements of||
2243|025|W|the REMS Program for this medication. If you live in Canada or||
2243|026|W|any other country, consult your doctor and pharmacist for your||
2243|027|W|country's regulations.||
2243|028|B|||
2243|029|U|USES:  Fenfluramine is used to help control seizures in people||
2243|030|U|with Dravet syndrome or Lennox-Gastaut syndrome.||
2243|031|B|||
2243|032|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2243|033|H|Instructions for Use provided by your pharmacist before you start||
2243|034|H|using fenfluramine and each time you get a refill. If you have||
2243|035|H|any questions, ask your doctor or pharmacist.||
2243|036|H|   Take this medication by mouth with or without food as directed||
2243|037|H|by your doctor, usually twice daily. Carefully measure the dose||
2243|038|H|using the provided measuring device. Do not use a household spoon||
2243|039|H|because you may not get the correct dose.||
2243|040|H|   The dosage is based on your medical condition, weight,||
2243|041|H|response to treatment, and other medications you may be taking.||
2243|042|H|Be sure to tell your doctor and pharmacist about all the products||
2243|043|H|you use (including prescription drugs, nonprescription drugs, and||
2243|044|H|herbal products).||
2243|045|H|   To reduce your risk of side effects, your doctor may direct||
2243|046|H|you to start this medication at a low dose and gradually increase||
2243|047|H|your dose. Follow your doctor's instructions carefully. Take this||
2243|048|H|medication regularly to get the most benefit from it. To help you||
2243|049|H|remember, take it at the same times each day.||
2243|050|H|   Do not stop taking this medication without consulting your||
2243|051|H|doctor. Some conditions may become worse when this drug is||
2243|052|H|suddenly stopped. Your dose may need to be gradually decreased.||
2243|053|H|   Tell your doctor if your condition does not get better or if||
2243|054|H|it gets worse.||
2243|055|B|||
2243|056|S|SIDE EFFECTS:  See also Warning section.||
2243|057|S|   Decreased appetite, weight loss, drowsiness, tiredness,||
2243|058|S|diarrhea, constipation, drooling, or shaking (tremor) may occur.||
2243|059|S|If any of these effects last or get worse, tell your doctor||
2243|060|S|promptly.||
2243|061|S|   Remember that this medication has been prescribed because your||
2243|062|S|doctor has judged that the benefit to you is greater than the||
2243|063|S|risk of side effects. Many people using this medication do not||
2243|064|S|have serious side effects.||
2243|065|S|   This medication may raise your blood pressure. Check your||
2243|066|S|blood pressure regularly and tell your doctor if the results are||
2243|067|S|high.||
2243|068|S|   Tell your doctor right away if you have any serious side||
2243|069|S|effects, including: eye pain/swelling/redness, vision changes||
2243|070|S|(such as seeing rainbows around lights at night, blurred vision).||
2243|071|S|   A small number of people who take anticonvulsants for any||
2243|072|S|condition (such as seizure, bipolar disorder, pain) may||
2243|073|S|experience depression, suicidal thoughts/attempts, or other||
2243|074|S|mental/mood problems. Tell your doctor right away if you or your||
2243|075|S|family/caregiver notice any unusual/sudden changes in your mood,||
2243|076|S|thoughts, or behavior such as signs of depression, suicidal||
2243|077|S|thoughts/attempts, thoughts about harming yourself.||
2243|078|S|   This medication may increase serotonin and rarely cause a very||
2243|079|S|serious condition called serotonin syndrome/toxicity. The risk||
2243|080|S|increases if you are also taking other drugs that increase||
2243|081|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2243|082|S|take (see Drug Interactions section). Get medical help right away||
2243|083|S|if you develop some of the following symptoms: fast heartbeat,||
2243|084|S|hallucinations, loss of coordination, severe dizziness, severe||
2243|085|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2243|086|S|unusual agitation/restlessness.||
2243|087|S|   A very serious allergic reaction to this drug is rare.||
2243|088|S|However, get medical help right away if you notice any symptoms||
2243|089|S|of a serious allergic reaction, including: rash, itching/swelling||
2243|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2243|091|S|breathing.||
2243|092|S|   This is not a complete list of possible side effects. If you||
2243|093|S|notice other effects not listed above, contact your doctor or||
2243|094|S|pharmacist.||
2243|095|S|   In the US -||
2243|096|S|   Call your doctor for medical advice about side effects. You||
2243|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2243|098|S|www.fda.gov/medwatch.||
2243|099|S|   In Canada - Call your doctor for medical advice about side||
2243|100|S|effects. You may report side effects to Health Canada at||
2243|101|S|1-866-234-2345.||
2243|102|B|||
2243|103|P|PRECAUTIONS:  Before taking fenfluramine, tell your doctor or||
2243|104|P|pharmacist if you are allergic to it; or if you have any other||
2243|105|P|allergies. This product may contain inactive ingredients, which||
2243|106|P|can cause allergic reactions or other problems. Talk to your||
2243|107|P|pharmacist for more details.||
2243|108|P|   Before using this medication, tell your doctor or pharmacist||
2243|109|P|your medical history, especially of: heart problems (such as||
2243|110|P|valvular heart disease), lung disease (such as pulmonary arterial||
2243|111|P|hypertension), weight loss, high blood pressure, mental/mood||
2243|112|P|disorders (such as depression, thoughts of suicide, psychosis),||
2243|113|P|glaucoma, kidney disease, liver disease.||
2243|114|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
2243|115|P|can make you more drowsy. Do not drive, use machinery, or do||
2243|116|P|anything that needs alertness until you can do it safely. Avoid||
2243|117|P|alcoholic beverages. Talk to your doctor if you are using||
2243|118|P|marijuana (cannabis).||
2243|119|P|   Before having surgery, tell your doctor or dentist about all||
2243|120|P|the products you use (including prescription drugs,||
2243|121|P|nonprescription drugs, and herbal products).||
2243|122|P|   Children may be more sensitive to the side effects of this||
2243|123|P|drug, especially decreased appetite and weight loss. Monitor||
2243|124|P|weight closely in children who are taking this drug.||
2243|125|P|   During pregnancy, this medication should be used only when||
2243|126|P|clearly needed. However, since untreated seizures are a serious||
2243|127|P|condition that can harm both a pregnant woman and her unborn||
2243|128|P|baby, do not stop taking this medication unless directed by your||
2243|129|P|doctor. If you are planning pregnancy, become pregnant, or think||
2243|130|P|you may be pregnant, discuss with your doctor right away the||
2243|131|P|benefits and risks of using this medication during pregnancy.||
2243|132|P|   It is unknown if this drug passes into breast milk. Consult||
2243|133|P|your doctor before breastfeeding.||
2243|134|B|||
2243|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2243|136|I|medications work or increase your risk for serious side effects.||
2243|137|I|This document does not contain all possible drug interactions.||
2243|138|I|Keep a list of all the products you use (including||
2243|139|I|prescription/nonprescription drugs and herbal products) and share||
2243|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
2243|141|I|the dosage of any medicines without your doctor's approval.||
2243|142|I|   Taking MAO inhibitors with this medication may cause a serious||
2243|143|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2243|144|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2243|145|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2243|146|I|selegiline, tranylcypromine) during treatment with this||
2243|147|I|medication. Most MAO inhibitors should also not be taken for two||
2243|148|I|weeks before and after treatment with this medication. Ask your||
2243|149|I|doctor when to start or stop taking this medication.||
2243|150|I|   The risk of serotonin syndrome/toxicity increases if you are||
2243|151|I|also taking other drugs that increase serotonin. Examples include||
2243|152|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
2243|153|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2243|154|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2243|155|I|serotonin syndrome/toxicity may be more likely when you start or||
2243|156|I|increase the dose of these drugs.||
2243|157|I|   Tell your doctor or pharmacist if you are using other products||
2243|158|I|that cause drowsiness such as opioid pain or cough relievers||
2243|159|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2243|160|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2243|161|I|zolpidem), muscle relaxants (such as carisoprodol,||
2243|162|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2243|163|I|diphenhydramine).||
2243|164|I|   Check the labels on all your medicines (such as allergy or||
2243|165|I|cough-and-cold products) because they may contain ingredients||
2243|166|I|that cause drowsiness. Ask your pharmacist about using those||
2243|167|I|products safely.||
2243|168|B|||
2243|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2243|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2243|171|O|poison control center right away. US residents can call||
2243|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2243|173|O|Symptoms of overdose may include: fast heartbeat, widened pupils,||
2243|174|O|muscle spasms, trouble breathing.||
2243|175|B|||
2243|176|N|NOTES:  Do not share this medication with others.||
2243|177|N|   Lab and/or medical tests (such as weight, blood pressure,||
2243|178|N|heart function) must be done before you start taking this||
2243|179|N|medication and while you are taking it. Keep all medical and lab||
2243|180|N|appointments. Consult your doctor for more details.||
2243|181|B|||
2243|182|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2243|183|D|remember. If it is near the time of the next dose, skip the||
2243|184|D|missed dose. Take your next dose at the regular time. Do not||
2243|185|D|double the dose to catch up.||
2243|186|B|||
2243|187|R|STORAGE:  Store at room temperature. Do not refrigerate or||
2243|188|R|freeze. Once the bottle is opened, this medication expires after||
2243|189|R|3 months. Keep all medications away from children and pets.||
2243|190|R|   Do not flush medications down the toilet or pour them into a||
2243|191|R|drain unless instructed to do so. Properly discard this product||
2243|192|R|when it is expired or no longer needed. Consult your pharmacist||
2243|193|R|or local waste disposal company.||
2243|194|B|||
2243|195|A|Information last revised October 2025.||
2243|196|A|Copyright(c) 2025 First Databank, Inc.||
2243|197|B|||
2244|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2244|002|Z|does NOT have all possible information about this product. This||
2244|003|Z|information does not assure that this product is safe, effective,||
2244|004|Z|or appropriate for you. This information is not individual||
2244|005|Z|medical advice and does not substitute for the advice of your||
2244|006|Z|health care professional. Always ask your health care||
2244|007|Z|professional for complete information about this product and your||
2244|008|Z|specific health needs.||
2244|009|B|||
2244|010|T|LORAZEPAM CONCENTRATE - ORAL||
2244|011|F|(lor-AYE-zeh-pam)||
2244|012|B|||
2244|013|C|COMMON BRAND NAME(S): Lorazepam Intensol||
2244|014|B|||
2244|015|W|WARNING:  Lorazepam has a risk for abuse and addiction, which can||
2244|016|W|lead to overdose and death. Taking this medication with alcohol||
2244|017|W|or other drugs that can cause drowsiness or breathing problems||
2244|018|W|(especially opioid medications such as codeine, hydrocodone) may||
2244|019|W|cause very serious side effects, including death. To lower your||
2244|020|W|risk, your doctor should have you take the smallest dose of||
2244|021|W|lorazepam that works, and take it for the shortest possible time.||
2244|022|W|Be sure you know how to take lorazepam and what other drugs you||
2244|023|W|should avoid taking with it. See also Drug Interactions section.||
2244|024|W|Get medical help right away if any of these very serious side||
2244|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
2244|026|W|severe drowsiness/dizziness, difficulty waking up.||
2244|027|W|   Suddenly stopping this medication may cause serious (possibly||
2244|028|W|fatal) withdrawal, especially if you have used it for a long time||
2244|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
2244|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
2244|031|W|you have any withdrawal symptoms such as headaches, trouble||
2244|032|W|sleeping, restlessness, hallucinations/confusion, depression,||
2244|033|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
2244|034|W|to months.||
2244|035|B|||
2244|036|U|USES:  This medication is used to treat anxiety. Lorazepam||
2244|037|U|belongs to a class of drugs known as benzodiazepines which act on||
2244|038|U|the brain and nerves (central nervous system) to produce a||
2244|039|U|calming effect. This drug works by enhancing the effects of a||
2244|040|U|certain natural chemical in the body (GABA).||
2244|041|B|||
2244|042|V|OTHER USES:  This section contains uses of this drug that are not||
2244|043|V|listed in the approved professional labeling for the drug but||
2244|044|V|that may be prescribed by your health care professional. Use this||
2244|045|V|drug for a condition that is listed in this section only if it||
2244|046|V|has been so prescribed by your health care professional.||
2244|047|V|   If directed by your doctor, this drug may also be used for||
2244|048|V|sleeping trouble (insomnia) or to reduce the symptoms of alcohol||
2244|049|V|withdrawal. It may also be used to reduce the risk of nausea and||
2244|050|V|vomiting due to chemotherapy.||
2244|051|B|||
2244|052|H|HOW TO USE:  See also Warning section.||
2244|053|H|   Read the Medication Guide provided by your pharmacist before||
2244|054|H|you start using lorazepam and each time you get a refill. If you||
2244|055|H|have any questions, ask your doctor or pharmacist.||
2244|056|H|   This medication is a high-strength concentrated liquid. Use||
2244|057|H|the provided medicine dropper to carefully measure the exact||
2244|058|H|amount of medication prescribed by your doctor. You may mix the||
2244|059|H|measured dose with a small amount of juice, water, soda,||
2244|060|H|applesauce or pudding. Stir in one dose and mix gently for a few||
2244|061|H|seconds. After preparing one dose, drink or eat the entire||
2244|062|H|mixture right away. Do not prepare a supply for future use. Ask||
2244|063|H|your pharmacist if you have any questions.||
2244|064|H|   The dosage is based on your medical condition, age, and||
2244|065|H|response to treatment. If directed by your doctor, use this||
2244|066|H|medication regularly in order to get the most benefit from it. To||
2244|067|H|help you remember, use it at the same time(s) each day.||
2244|068|H|   Do not suddenly stop using this drug without consulting your||
2244|069|H|doctor. Some conditions may become worse when this drug is||
2244|070|H|abruptly stopped. Your dose may need to be gradually decreased.||
2244|071|H|   When this medication is used for a long time, it may not work||
2244|072|H|as well. Talk with your doctor if this medication stops working||
2244|073|H|well.||
2244|074|H|   Though it helps many people, this medication may sometimes||
2244|075|H|cause addiction. This risk may be higher if you have a substance||
2244|076|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2244|077|H|Take this medication exactly as prescribed to lower the risk of||
2244|078|H|addiction. Ask your doctor or pharmacist for more details.||
2244|079|H|   Tell your doctor if your condition lasts or gets worse.||
2244|080|B|||
2244|081|S|SIDE EFFECTS:  See also Warning section.||
2244|082|S|   Drowsiness, dizziness, loss of coordination, headache, nausea,||
2244|083|S|blurred vision, change in sexual interest/ability, constipation,||
2244|084|S|heartburn, or change in appetite may occur. If any of these||
2244|085|S|effects last or get worse, tell your doctor or pharmacist||
2244|086|S|promptly.||
2244|087|S|   Remember that this medication has been prescribed because your||
2244|088|S|doctor has judged that the benefit to you is greater than the||
2244|089|S|risk of side effects. Many people using this medication do not||
2244|090|S|have serious side effects.||
2244|091|S|   Tell your doctor right away if you have any serious side||
2244|092|S|effects, including: mental/mood changes (such as hallucinations,||
2244|093|S|depression, thoughts of suicide), trouble speaking, vision||
2244|094|S|changes, unusual weakness, trouble walking, memory problems,||
2244|095|S|signs of infection (such as sore throat that doesn't go away,||
2244|096|S|fever, chills).||
2244|097|S|   Get medical help right away if you have any very serious side||
2244|098|S|effects, including: seizures, slow/shallow breathing.||
2244|099|S|   This medication can rarely have the opposite of its usual||
2244|100|S|calming effect. Symptoms of this opposite effect may include||
2244|101|S|agitation, irritability, violent behavior, confusion,||
2244|102|S|restlessness, excitement, and talking more than normal. Tell your||
2244|103|S|doctor right away if you notice any of these effects.||
2244|104|S|   A very serious allergic reaction to this drug is rare.||
2244|105|S|However, get medical help right away if you notice any symptoms||
2244|106|S|of a serious allergic reaction, including: rash, itching/swelling||
2244|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2244|108|S|breathing.||
2244|109|S|   This is not a complete list of possible side effects. If you||
2244|110|S|notice other effects not listed above, contact your doctor or||
2244|111|S|pharmacist.||
2244|112|S|   In the US -||
2244|113|S|   Call your doctor for medical advice about side effects. You||
2244|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2244|115|S|www.fda.gov/medwatch.||
2244|116|S|   In Canada - Call your doctor for medical advice about side||
2244|117|S|effects. You may report side effects to Health Canada at||
2244|118|S|1-866-234-2345.||
2244|119|B|||
2244|120|P|PRECAUTIONS:  Before taking lorazepam, tell your doctor or||
2244|121|P|pharmacist if you are allergic to it; or to other benzodiazepines||
2244|122|P|(such as alprazolam, clonazepam, diazepam); or if you have any||
2244|123|P|other allergies. This product may contain inactive ingredients,||
2244|124|P|which can cause allergic reactions or other problems. Talk to||
2244|125|P|your pharmacist for more details.||
2244|126|P|   Before using this medication, tell your doctor or pharmacist||
2244|127|P|your medical history, especially of: kidney disease, liver||
2244|128|P|disease, glaucoma, lung/breathing problems (such as sleep apnea),||
2244|129|P|mental/mood disorders (such as depression, psychosis), personal||
2244|130|P|or family history of a substance use disorder (such as overuse of||
2244|131|P|or addiction to drugs/alcohol).||
2244|132|P|   This drug may make you dizzy or drowsy or blur your vision.||
2244|133|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
2244|134|P|drowsy. Do not drive, use machinery, or do anything that needs||
2244|135|P|alertness or clear vision until you can do it safely. Avoid||
2244|136|P|alcoholic beverages. Talk to your doctor if you are using||
2244|137|P|marijuana (cannabis).||
2244|138|P|   Before having surgery, tell your doctor or dentist about all||
2244|139|P|the products you use (including prescription drugs,||
2244|140|P|nonprescription drugs, and herbal products).||
2244|141|P|   Older adults may be more sensitive to the side effects of this||
2244|142|P|drug, especially loss of coordination and drowsiness. Loss of||
2244|143|P|coordination and drowsiness may increase the risk of falling.||
2244|144|P|Also, lorazepam may have the opposite of its usual calming effect||
2244|145|P|in older adults (see also Side Effects section).||
2244|146|P|   This drug may have the opposite of its usual calming effect in||
2244|147|P|children, causing restlessness, shaking, or mental/mood changes||
2244|148|P|(such as agitation, hallucinations).||
2244|149|P|   Tell your doctor if you are pregnant or plan to become||
2244|150|P|pregnant. You should not become pregnant while using lorazepam.||
2244|151|P|Lorazepam may harm an unborn baby. Newborn babies of mothers who||
2244|152|P|use this medication late in pregnancy may have symptoms such as||
2244|153|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
2244|154|P|feeding. If you become pregnant, talk to your doctor right away||
2244|155|P|about the risks and benefits of this medication.||
2244|156|P|   This drug passes into breast milk. Consult your doctor before||
2244|157|P|breastfeeding.||
2244|158|B|||
2244|159|I|DRUG INTERACTIONS:  See also Warning section.||
2244|160|I|   Drug interactions may change how your medications work or||
2244|161|I|increase your risk for serious side effects. This document does||
2244|162|I|not contain all possible drug interactions. Keep a list of all||
2244|163|I|the products you use (including prescription/nonprescription||
2244|164|I|drugs and herbal products) and share it with your doctor and||
2244|165|I|pharmacist. Do not start, stop, or change the dosage of any||
2244|166|I|medicines without your doctor's approval.||
2244|167|I|   Some products that may interact with this drug include:||
2244|168|I|clozapine, kava, sodium oxybate (also known as gamma||
2244|169|I|hydroxybutyrate or GHB).||
2244|170|I|   The risk of serious side effects (such as slow/shallow||
2244|171|I|breathing, severe drowsiness/dizziness) may be increased if this||
2244|172|I|medication is taken with other products that may also cause||
2244|173|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2244|174|I|if you are taking other products such as opioid pain or cough||
2244|175|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2244|176|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
2244|177|I|diazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2244|178|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2244|179|I|diphenhydramine).||
2244|180|I|   Check the labels on all your medicines (such as allergy or||
2244|181|I|cough-and-cold products) because they may contain ingredients||
2244|182|I|that cause drowsiness. Ask your pharmacist about using those||
2244|183|I|products safely.||
2244|184|B|||
2244|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2244|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2244|187|O|poison control center right away. US residents can call||
2244|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2244|189|O|Symptoms of overdose may include confusion, slow reflexes,||
2244|190|O|clumsiness, deep sleep, and loss of consciousness.||
2244|191|B|||
2244|192|N|NOTES:  Lifestyle changes such as starting a stress reduction||
2244|193|N|program may increase the effectiveness of this medication. Talk||
2244|194|N|to your doctor or pharmacist about lifestyle changes that might||
2244|195|N|benefit you.||
2244|196|N|   Do not share this medication with others. Sharing it is||
2244|197|N|against the law.||
2244|198|N|   Lab and/or medical tests (such as blood counts, liver||
2244|199|N|function) should be done while you are taking this medication.||
2244|200|N|Keep all medical and lab appointments. Consult your doctor for||
2244|201|N|more details.||
2244|202|B|||
2244|203|D|MISSED DOSE:  If you miss a dose and are taking more than 1 dose||
2244|204|D|daily, do not take it if it is almost time for the next dose.||
2244|205|D|Instead, skip the missed dose. Take your next dose at the regular||
2244|206|D|time. Do not double the dose to catch up. If you take it once||
2244|207|D|daily at bedtime and miss a dose, do not take it the following||
2244|208|D|morning. Call your doctor to find out what to do.||
2244|209|B|||
2244|210|R|STORAGE:  Store in the refrigerator. Keep all medications away||
2244|211|R|from children and pets.||
2244|212|R|   Do not flush medications down the toilet or pour them into a||
2244|213|R|drain unless instructed to do so. Properly discard this product||
2244|214|R|when it is expired or no longer needed. Consult your pharmacist||
2244|215|R|or local waste disposal company.||
2244|216|B|||
2244|217|M|MEDICAL ALERT:  Your condition can cause complications in a||
2244|218|M|medical emergency. For information about enrolling in MedicAlert,||
2244|219|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2244|220|B|||
2244|221|A|Information last revised May 2025.||
2244|222|A|Copyright(c) 2025 First Databank, Inc.||
2244|223|B|||
2245|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2245|002|Z|does NOT have all possible information about this product. This||
2245|003|Z|information does not assure that this product is safe, effective,||
2245|004|Z|or appropriate for you. This information is not individual||
2245|005|Z|medical advice and does not substitute for the advice of your||
2245|006|Z|health care professional. Always ask your health care||
2245|007|Z|professional for complete information about this product and your||
2245|008|Z|specific health needs.||
2245|009|B|||
2245|010|T|HYDROCORTISONE FOAM - RECTAL||
2245|011|F|(HYE-droe-KOR-ti-sone)||
2245|012|B|||
2245|013|C|COMMON BRAND NAME(S): Cortifoam||
2245|014|B|||
2245|015|U|USES:  This medication is used to treat a certain intestinal||
2245|016|U|problem known as ulcerative colitis of the rectum, also called||
2245|017|U|ulcerative proctitis. It does not cure this condition but it may||
2245|018|U|relieve rectal pain, diarrhea, and bloody stools caused by||
2245|019|U|swelling (inflammation). Hydrocortisone belongs to a class of||
2245|020|U|drugs called corticosteroids. This medication works by decreasing||
2245|021|U|inflammation directly in the rectum. It is usually used in people||
2245|022|U|who cannot use corticosteroid enemas.||
2245|023|B|||
2245|024|H|HOW TO USE:  Read the directions for use that come with this||
2245|025|H|product. If you have any questions, ask your doctor or||
2245|026|H|pharmacist.||
2245|027|H|   Use this product in the rectum as directed by your doctor,||
2245|028|H|usually once or twice daily for 2 to 3 weeks, then every other||
2245|029|H|day. The dosage and length of treatment are based on your medical||
2245|030|H|condition and response to treatment. To reduce the chance of side||
2245|031|H|effects, your doctor will slowly lower your dose, after you have||
2245|032|H|a positive response to treatment, to the lowest effective dose||
2245|033|H|that controls your symptoms. If you have a worsening of your||
2245|034|H|symptoms, your doctor may need to increase your dose temporarily.||
2245|035|H|Follow your doctor's directions.||
2245|036|H|   Do not insert any part of the container into the anus. Use the||
2245|037|H|enclosed applicator to apply this drug. Leave the cap of the||
2245|038|H|container on while using the product. Shake the container well||
2245|039|H|for 5-10 seconds before use and hold upright. Fill the applicator||
2245|040|H|with foam according to the instructions in the package. Gently||
2245|041|H|insert the applicator tip into the anus, and gently push the||
2245|042|H|plunger to apply the foam. Remove the applicator.||
2245|043|H|   After inserting the foam, pull the applicator apart and wash||
2245|044|H|all parts with warm water. Rinse the container cap and tip to||
2245|045|H|prevent any blockage. Wash your hands after use.||
2245|046|H|   Use this medication regularly as prescribed to get the most||
2245|047|H|benefit from it. It may take 5 to 7 days to notice an||
2245|048|H|improvement.||
2245|049|H|   Do not apply large amounts of this product, use it more often,||
2245|050|H|or use it for longer than prescribed. Your condition will not||
2245|051|H|improve any faster, and your risk of side effects may increase.||
2245|052|H|If you have been using this medication for a long time, do not||
2245|053|H|stop using it without consulting your doctor. Some conditions may||
2245|054|H|become worse when the drug is suddenly stopped. Your dose may||
2245|055|H|need to be gradually decreased.||
2245|056|H|   Tell your doctor if your condition does not get better after 2||
2245|057|H|to 3 weeks of treatment or if it gets worse.||
2245|058|B|||
2245|059|S|SIDE EFFECTS:  Itching or burning in the rectum may occur. If||
2245|060|S|either of these effects lasts or gets worse, tell your doctor or||
2245|061|S|pharmacist promptly.||
2245|062|S|   Remember that this medication has been prescribed because your||
2245|063|S|doctor has judged that the benefit to you is greater than the||
2245|064|S|risk of side effects. Many people using this medication do not||
2245|065|S|have serious side effects.||
2245|066|S|   Rarely, it is possible this medication will be absorbed into||
2245|067|S|the bloodstream. This can lead to side effects of too much||
2245|068|S|corticosteroid. These side effects are more likely in children||
2245|069|S|and people who use this medication for a long time. Tell your||
2245|070|S|doctor right away if any of the following side effects occur:||
2245|071|S|unusual/extreme tiredness, weight loss, headache, swelling||
2245|072|S|ankles/feet, increased thirst/urination, vision problems.||
2245|073|S|   Tell your doctor right away if you have any serious side||
2245|074|S|effects, including: rectal bleeding that is new or doesn't go||
2245|075|S|away, unusual bruising/bleeding, symptoms of stomach/intestinal||
2245|076|S|bleeding (such as stomach/abdominal pain, black/tarry stools,||
2245|077|S|vomit that looks like coffee grounds), bone pain, easily broken||
2245|078|S|bones, mental/mood changes (such as depression, mood swings,||
2245|079|S|agitation), muscle weakness/pain, irregular heartbeat, signs of||
2245|080|S|infection (such as sore throat that doesn't go away, fever,||
2245|081|S|chills, painful urination, worsening redness/irritation near the||
2245|082|S|anus).||
2245|083|S|   A very serious allergic reaction to this drug is rare.||
2245|084|S|However, get medical help right away if you notice any symptoms||
2245|085|S|of a serious allergic reaction, including: rash, itching/swelling||
2245|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2245|087|S|breathing.||
2245|088|S|   This is not a complete list of possible side effects. If you||
2245|089|S|notice other effects not listed above, contact your doctor or||
2245|090|S|pharmacist.||
2245|091|S|   In the US -||
2245|092|S|   Call your doctor for medical advice about side effects. You||
2245|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2245|094|S|www.fda.gov/medwatch.||
2245|095|S|   In Canada - Call your doctor for medical advice about side||
2245|096|S|effects. You may report side effects to Health Canada at||
2245|097|S|1-866-234-2345.||
2245|098|B|||
2245|099|P|PRECAUTIONS:  Before using hydrocortisone, tell your doctor or||
2245|100|P|pharmacist if you are allergic to it; or to other corticosteroids||
2245|101|P|(such as prednisone); or if you have any other allergies. This||
2245|102|P|product may contain inactive ingredients, which can cause||
2245|103|P|allergic reactions or other problems. Talk to your pharmacist for||
2245|104|P|more details.||
2245|105|P|   Before using this medication, tell your doctor or pharmacist||
2245|106|P|your medical history, especially of: other stomach/intestinal||
2245|107|P|problems (such as ulcers, blockage, bleeding, infection, recent||
2245|108|P|surgery), infections (such as tuberculosis, fungal infections),||
2245|109|P|certain eye conditions (cataracts, glaucoma, herpes infection of||
2245|110|P|the eye), heart problems (such as heart failure, recent heart||
2245|111|P|attack), high blood pressure, liver disease, kidney disease,||
2245|112|P|thyroid problems (overactive or underactive thyroid disease),||
2245|113|P|diabetes, bone loss (osteoporosis), bleeding or blood clotting||
2245|114|P|problems, mental/mood conditions (such as psychosis, depression),||
2245|115|P|low potassium blood level.||
2245|116|P|   Limit alcoholic beverages while using this medication to||
2245|117|P|decrease the risk of stomach/intestinal bleeding.||
2245|118|P|   Rarely, using corticosteroid medications for a long time can||
2245|119|P|make it more difficult for your body to respond to physical||
2245|120|P|stress. Before having surgery or emergency treatment, or if you||
2245|121|P|get a serious illness/injury, tell your doctor or dentist that||
2245|122|P|you are using this medication or have used this medication within||
2245|123|P|the past few months.||
2245|124|P|   Tell your health care professional that you are using||
2245|125|P|hydrocortisone before having any immunizations, vaccinations, or||
2245|126|P|skin tests. Avoid contact with people who have recently received||
2245|127|P|live vaccines (such as flu vaccine inhaled through the nose).||
2245|128|P|   Rarely, this drug can make you more likely to get infections||
2245|129|P|or may make current infections worse. Stay away from anyone who||
2245|130|P|has an infection that may easily spread (such as chickenpox,||
2245|131|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2245|132|P|exposed to an infection or for more details.||
2245|133|P|   Older adults may be more sensitive to the side effects of this||
2245|134|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
2245|135|P|mental/mood changes (such as confusion).||
2245|136|P|   Though it is unlikely, this medication may temporarily slow||
2245|137|P|down a child's growth if used for a long time. See the doctor||
2245|138|P|regularly so your child's height can be checked.||
2245|139|P|   During pregnancy, this medication should be used only when||
2245|140|P|clearly needed and not for prolonged periods. Other forms of||
2245|141|P|hydrocortisone (given by mouth or by injection) may harm an||
2245|142|P|unborn baby. Discuss the risks and benefits with your doctor.||
2245|143|P|   It is unknown if this drug passes into breast milk. However,||
2245|144|P|it is unlikely to harm a nursing infant. Consult your doctor||
2245|145|P|before breastfeeding.||
2245|146|B|||
2245|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2245|148|I|medications work or increase your risk for serious side effects.||
2245|149|I|This document does not contain all possible drug interactions.||
2245|150|I|Keep a list of all the products you use (including||
2245|151|I|prescription/nonprescription drugs and herbal products) and share||
2245|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
2245|153|I|the dosage of any medicines without your doctor's approval.||
2245|154|I|   Some products that may interact with this drug are:||
2245|155|I|aldesleukin, "blood thinners" (such as warfarin), desmopressin.||
2245|156|I|   Check all prescription and nonprescription medicine labels||
2245|157|I|carefully since many medications contain pain relievers/fever||
2245|158|I|reducers (including aspirin, salicylates, NSAIDs such as||
2245|159|I|ibuprofen, naproxen) that may increase your risk of bleeding when||
2245|160|I|taken with corticosteroids. However, if your doctor has told you||
2245|161|I|to take low-dose aspirin to prevent heart attack or stroke||
2245|162|I|(usually 81-162 milligrams a day), you should keep taking the||
2245|163|I|aspirin unless your doctor tells you not to. Ask your doctor or||
2245|164|I|pharmacist for more details.||
2245|165|B|||
2245|166|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2245|167|O|has overdosed and has serious symptoms such as passing out or||
2245|168|O|trouble breathing, call 911. Otherwise, call a poison control||
2245|169|O|center right away. US residents can call 1-800-222-1222. Canada||
2245|170|O|residents can call 1-844-764-7669.||
2245|171|B|||
2245|172|N|NOTES:  Do not share this medication with others.||
2245|173|N|   Lab and/or medical tests (such as sigmoidoscopy, adrenal gland||
2245|174|N|function) should be done while you are using this medication.||
2245|175|N|Keep all medical and lab appointments. Consult your doctor for||
2245|176|N|more details.||
2245|177|B|||
2245|178|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2245|179|D|If it is near the time of the next dose, skip the missed dose.||
2245|180|D|Use your next dose at the regular time. Do not double the dose to||
2245|181|D|catch up.||
2245|182|B|||
2245|183|R|STORAGE:  Store at room temperature. Do not refrigerate. Do not||
2245|184|R|store or use near heat or open flame. The contents of the||
2245|185|R|container are under pressure. Do not puncture or burn the||
2245|186|R|container. Keep all medications away from children and pets.||
2245|187|R|   Do not flush medications down the toilet or pour them into a||
2245|188|R|drain unless instructed to do so. Properly discard this product||
2245|189|R|when it is expired or no longer needed. Consult your pharmacist||
2245|190|R|or local waste disposal company.||
2245|191|B|||
2245|192|A|Information last revised April 2025.||
2245|193|A|Copyright(c) 2025 First Databank, Inc.||
2245|194|B|||
2248|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2248|002|Z|does NOT have all possible information about this product. This||
2248|003|Z|information does not assure that this product is safe, effective,||
2248|004|Z|or appropriate for you. This information is not individual||
2248|005|Z|medical advice and does not substitute for the advice of your||
2248|006|Z|health care professional. Always ask your health care||
2248|007|Z|professional for complete information about this product and your||
2248|008|Z|specific health needs.||
2248|009|B|||
2248|010|T|OCTREOTIDE PEN - INJECTION||
2248|011|F|(ok-TREE-oh-tide)||
2248|012|B|||
2248|013|C|COMMON BRAND NAME(S): Bynfezia||
2248|014|B|||
2248|015|U|USES:  Octreotide is used to treat severe watery diarrhea and||
2248|016|U|sudden reddening of the face and neck caused by certain types of||
2248|017|U|tumors (such as carcinoid tumors, vasoactive intestinal peptide||
2248|018|U|tumors) that are found usually in the intestines and pancreas.||
2248|019|U|The symptoms occur when these tumors make too much of certain||
2248|020|U|natural substances (hormones). This medication works by blocking||
2248|021|U|the production of these hormones. By decreasing watery diarrhea,||
2248|022|U|octreotide helps to reduce the loss of body fluids and minerals.||
2248|023|U|   Octreotide is also used to treat a certain condition||
2248|024|U|(acromegaly) that occurs when the body makes too much of a||
2248|025|U|certain natural substance called growth hormone. Treating||
2248|026|U|acromegaly helps reduce the risk of serious problems such as||
2248|027|U|diabetes and heart disease. Octreotide works by decreasing how||
2248|028|U|much growth hormone your body makes.||
2248|029|U|   This drug is not a cure for these conditions. This medication||
2248|030|U|is usually used with other treatment (such as surgery, radiation,||
2248|031|U|other drugs).||
2248|032|B|||
2248|033|H|HOW TO USE:  Read the Instructions for Use if available from your||
2248|034|H|pharmacist before you start using octreotide and each time you||
2248|035|H|get a refill. Ask your health care professional how to prepare||
2248|036|H|and use this medication. If you have any questions, ask your||
2248|037|H|doctor or pharmacist.||
2248|038|H|   Inject this medication under the skin as directed by your||
2248|039|H|doctor, usually 2 to 4 times daily. The injection is given in the||
2248|040|H|upper arms, thighs, or abdomen (except for a 2-inch area around||
2248|041|H|your belly button). The dosage is based on your medical condition||
2248|042|H|and response to treatment.||
2248|043|H|   Take the medication out of the refrigerator at least 20 to 30||
2248|044|H|minutes before you inject it to allow it to reach room||
2248|045|H|temperature. Do not warm up this medication any other way (for||
2248|046|H|example, do not heat it in the microwave, place it in hot water,||
2248|047|H|or leave it in direct sunlight). Before using, check this product||
2248|048|H|for particles or discoloration. If either is present, do not use||
2248|049|H|the liquid. Before injecting each dose, clean the skin you are||
2248|050|H|going to inject into (the injection site) with rubbing alcohol.||
2248|051|H|Change the injection site each time to lessen injury under the||
2248|052|H|skin. Do not inject into skin that is tender, bruised, red, hard,||
2248|053|H|or damaged or into moles or scars. To lessen bruising, do not rub||
2248|054|H|the injection site after a shot. Learn how to store and discard||
2248|055|H|medical supplies safely.||
2248|056|H|   Use this medication regularly to get the most benefit from it.||
2248|057|H|To help you remember, use it at the same times each day.||
2248|058|H|   Do not increase your dose or use this drug more often or for||
2248|059|H|longer than prescribed. Your condition will not improve any||
2248|060|H|faster, and your risk of side effects will increase.||
2248|061|H|   Tell your doctor if your condition does not get better or if||
2248|062|H|it gets worse.||
2248|063|B|||
2248|064|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach upset, gas,||
2248|065|S|bloating, dizziness, or headache may occur. Pain and irritation||
2248|066|S|at the injection site may also occur. If any of these effects||
2248|067|S|last or get worse, tell your doctor or pharmacist promptly.||
2248|068|S|   Remember that this medication has been prescribed because your||
2248|069|S|doctor has judged that the benefit to you is greater than the||
2248|070|S|risk of side effects. Many people using this medication do not||
2248|071|S|have serious side effects.||
2248|072|S|   Tell your doctor right away if you have any serious side||
2248|073|S|effects, including: signs of gallbladder/liver problems (such as||
2248|074|S|fever, nausea/vomiting that doesn't stop, loss of appetite,||
2248|075|S|stomach/abdominal pain, yellowing eyes/skin, dark urine,||
2248|076|S|unexplained pain in the back/right shoulder), signs of||
2248|077|S|underactive thyroid (such as unexplained weight gain, cold||
2248|078|S|intolerance, severe constipation, unusual tiredness,||
2248|079|S|growth/lump/swelling on the front of the neck),||
2248|080|S|slow/fast/irregular heartbeat, weight loss, change in stool||
2248|081|S|color.||
2248|082|S|   This medication may cause changes in blood sugar, especially||
2248|083|S|if you have diabetes. Symptoms of high blood sugar include||
2248|084|S|increased thirst and urination. Symptoms of low blood sugar||
2248|085|S|include sudden sweating, shaking, fast heartbeat, hunger, blurred||
2248|086|S|vision, dizziness, or tingling hands/feet. Tell your doctor right||
2248|087|S|away if you experience symptoms of high or low blood sugar while||
2248|088|S|using this medication. If you already have diabetes, check your||
2248|089|S|blood sugar regularly as directed and share the results with your||
2248|090|S|doctor. Your doctor may need to adjust your diabetes medication,||
2248|091|S|exercise program, or diet.||
2248|092|S|   A very serious allergic reaction to this drug is rare.||
2248|093|S|However, get medical help right away if you notice any symptoms||
2248|094|S|of a serious allergic reaction, including: rash, itching/swelling||
2248|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2248|096|S|breathing.||
2248|097|S|   This is not a complete list of possible side effects. If you||
2248|098|S|notice other effects not listed above, contact your doctor or||
2248|099|S|pharmacist.||
2248|100|S|   In the US -||
2248|101|S|   Call your doctor for medical advice about side effects. You||
2248|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2248|103|S|www.fda.gov/medwatch.||
2248|104|S|   In Canada - Call your doctor for medical advice about side||
2248|105|S|effects. You may report side effects to Health Canada at||
2248|106|S|1-866-234-2345.||
2248|107|B|||
2248|108|P|PRECAUTIONS:  Before using octreotide, tell your doctor or||
2248|109|P|pharmacist if you are allergic to it; or if you have any other||
2248|110|P|allergies. This product may contain inactive ingredients, which||
2248|111|P|can cause allergic reactions or other problems. Talk to your||
2248|112|P|pharmacist for more details.||
2248|113|P|   Before using this medication, tell your doctor or pharmacist||
2248|114|P|your medical history, especially of: kidney disease, liver||
2248|115|P|disease, diabetes, thyroid problems, gallbladder problems (such||
2248|116|P|as gallstones), heart problems (such as heart failure), nutrition||
2248|117|P|problems (such as decreased fat absorption, vitamin B12||
2248|118|P|deficiency).||
2248|119|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2248|120|P|can make you more dizzy. Do not drive, use machinery, or do||
2248|121|P|anything that needs alertness until you can do it safely. Limit||
2248|122|P|alcoholic beverages. Talk to your doctor if you are using||
2248|123|P|marijuana (cannabis).||
2248|124|P|   Before having surgery, tell your doctor or dentist about all||
2248|125|P|the products you use (including prescription drugs,||
2248|126|P|nonprescription drugs, and herbal products).||
2248|127|P|   If used for a long time (such as longer than 1 year), this||
2248|128|P|medication may slow a child's growth rate. However, the growth||
2248|129|P|rate catches up after treatment with the drug is stopped. Consult||
2248|130|P|your doctor for more information.||
2248|131|P|   Treatment with this medication may improve fertility in women||
2248|132|P|and may lead to unintended pregnancy. Ask your doctor for more||
2248|133|P|details.||
2248|134|P|   During pregnancy, this medication should be used only when||
2248|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
2248|136|P|   It is unknown if this medication passes into breast milk.||
2248|137|P|Consult your doctor before breastfeeding.||
2248|138|B|||
2248|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2248|140|I|medications work or increase your risk for serious side effects.||
2248|141|I|This document does not contain all possible drug interactions.||
2248|142|I|Keep a list of all the products you use (including||
2248|143|I|prescription/nonprescription drugs and herbal products) and share||
2248|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
2248|145|I|the dosage of any medicines without your doctor's approval.||
2248|146|B|||
2248|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2248|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2248|149|O|poison control center right away. US residents can call||
2248|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2248|151|B|||
2248|152|N|NOTES:  Do not share this medication with others.||
2248|153|N|   Lab and/or medical tests (such as blood sugar, thyroid||
2248|154|N|function, hormone levels, vitamin B12 levels) should be done||
2248|155|N|before you start using this medication and while you are using||
2248|156|N|it. Keep all medical and lab appointments. Consult your doctor||
2248|157|N|for more details.||
2248|158|B|||
2248|159|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2248|160|D|If it is near the time of the next dose, skip the missed dose.||
2248|161|D|Use your next dose at the regular time. Do not double the dose to||
2248|162|D|catch up.||
2248|163|B|||
2248|164|R|STORAGE:  Store the unused pen in the refrigerator. Do not||
2248|165|R|freeze. Keep the medication in the original carton to protect||
2248|166|R|from light. Once used, store this product at room temperature.||
2248|167|R|Discard the used pen after 28 days. Keep all medications away||
2248|168|R|from children and pets.||
2248|169|R|   Do not flush medications down the toilet or pour them into a||
2248|170|R|drain unless instructed to do so. Properly discard this product||
2248|171|R|when it is expired or no longer needed. Consult your pharmacist||
2248|172|R|or local waste disposal company.||
2248|173|B|||
2248|174|A|Information last revised October 2025.||
2248|175|A|Copyright(c) 2025 First Databank, Inc.||
2248|176|B|||
2250|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2250|002|Z|does NOT have all possible information about this product. This||
2250|003|Z|information does not assure that this product is safe, effective,||
2250|004|Z|or appropriate for you. This information is not individual||
2250|005|Z|medical advice and does not substitute for the advice of your||
2250|006|Z|health care professional. Always ask your health care||
2250|007|Z|professional for complete information about this product and your||
2250|008|Z|specific health needs.||
2250|009|B|||
2250|010|T|OMEPRAZOLE DELAYED-RELEASE TABLET - ORAL||
2250|011|F|(oh-MEH-pruh-zole)||
2250|012|B|||
2250|013|C|COMMON BRAND NAME(S): Prilosec OTC||
2250|014|B|||
2250|015|U|USES:  Omeprazole is used to treat certain stomach and esophagus||
2250|016|U|problems (such as acid reflux, ulcers). It works by decreasing||
2250|017|U|the amount of acid your stomach makes. It relieves symptoms such||
2250|018|U|as heartburn, difficulty swallowing, and cough. This medication||
2250|019|U|helps heal acid damage to the stomach and esophagus, helps||
2250|020|U|prevent ulcers, and may help prevent cancer of the esophagus.||
2250|021|U|Omeprazole belongs to a class of drugs known as proton pump||
2250|022|U|inhibitors (PPIs).||
2250|023|U|   If you are self-treating with this medication,||
2250|024|U|over-the-counter omeprazole products are used to treat frequent||
2250|025|U|heartburn (occurring 2 or more days a week). Since it may take 1||
2250|026|U|to 4 days to have full effect, these products do not relieve||
2250|027|U|heartburn right away.||
2250|028|U|   For over-the-counter products, carefully read the package||
2250|029|U|instructions to make sure the product is right for you. Check the||
2250|030|U|ingredients on the label even if you have used the product||
2250|031|U|before. The manufacturer may have changed the ingredients. Also,||
2250|032|U|products with similar brand names may contain different||
2250|033|U|ingredients meant for different purposes. Taking the wrong||
2250|034|U|product could harm you.||
2250|035|B|||
2250|036|H|HOW TO USE:  If your doctor has prescribed this medication for||
2250|037|H|you, read the Patient Information Leaflet if available from your||
2250|038|H|pharmacist before you start taking omeprazole and each time you||
2250|039|H|get a refill. If you are taking the over-the-counter product to||
2250|040|H|self-treat, read and follow all directions on the product package||
2250|041|H|before taking this medication.||
2250|042|H|   Take this medication by mouth as directed, usually once daily||
2250|043|H|before a meal. The dosage and length of treatment are based on||
2250|044|H|your medical condition and response to treatment. Children's||
2250|045|H|dosage is also based on weight. Do not increase your dose or take||
2250|046|H|this drug more often than directed. If you have any questions,||
2250|047|H|ask your doctor or pharmacist.||
2250|048|H|   Do not crush, break, or chew delayed-release tablets. Doing so||
2250|049|H|can release all of the drug at once, increasing the risk of side||
2250|050|H|effects.||
2250|051|H|   If you are using the disintegrating delayed-release tablets,||
2250|052|H|use dry hands to handle the tablets. Place the tablet on your||
2250|053|H|tongue and let it dissolve. After the tablet has dissolved, it||
2250|054|H|can be swallowed with or without water. The tablets can also be||
2250|055|H|swallowed whole with water.||
2250|056|H|   If needed, antacids may be taken along with this medication.||
2250|057|H|If you are also taking sucralfate, take omeprazole at least 30||
2250|058|H|minutes before sucralfate.||
2250|059|H|   Use this medication regularly to get the most benefit from it.||
2250|060|H|To help you remember, take it at the same time each day. Continue||
2250|061|H|to take this medication for the prescribed length of treatment||
2250|062|H|even if you are feeling better. If you are self-treating with the||
2250|063|H|over-the-counter product, do not take it for more than 14 days||
2250|064|H|unless directed by your doctor.||
2250|065|H|   Tell your doctor if your condition lasts or gets worse. If you||
2250|066|H|are self-treating, tell your doctor if your heartburn lasts after||
2250|067|H|14 days or if you need to use this medication more than once||
2250|068|H|every 4 months. The risk of side effects goes up over time. Ask||
2250|069|H|your doctor how long you should take this medication. If you||
2250|070|H|think you may have a serious medical problem, get medical help||
2250|071|H|right away.||
2250|072|B|||
2250|073|S|SIDE EFFECTS:  See also Precautions section.||
2250|074|S|   Headache or abdominal pain may occur. If any of these effects||
2250|075|S|last or get worse, tell your doctor or pharmacist promptly.||
2250|076|S|   If your doctor has directed you to use this product, remember||
2250|077|S|that your doctor has judged that the benefit to you is greater||
2250|078|S|than the risk of side effects. Many people using this medication||
2250|079|S|do not have serious side effects.||
2250|080|S|   Tell your doctor right away if you have any serious side||
2250|081|S|effects, including: symptoms of a low magnesium blood level (such||
2250|082|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
2250|083|S|(such as rash on nose and cheeks, new or worsening joint pain),||
2250|084|S|signs of kidney problems (such as change in the amount of urine,||
2250|085|S|pink/bloody urine).||
2250|086|S|   This medication may rarely cause a severe intestinal condition||
2250|087|S|due to a bacteria called C. difficile. This condition may occur||
2250|088|S|during treatment or weeks to months after treatment has stopped.||
2250|089|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2250|090|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2250|091|S|stool.||
2250|092|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2250|093|S|products because they may make symptoms worse.||
2250|094|S|   Rarely, proton pump inhibitors (such as omeprazole) have||
2250|095|S|caused vitamin B-12 deficiency. The risk is increased if they are||
2250|096|S|taken every day for a long time (3 years or longer). Tell your||
2250|097|S|doctor right away if you develop symptoms of vitamin B-12||
2250|098|S|deficiency (such as unusual weakness, sore tongue, or||
2250|099|S|numbness/tingling of the hands/feet).||
2250|100|S|   A very serious allergic reaction to this drug is rare.||
2250|101|S|However, get medical help right away if you notice any symptoms||
2250|102|S|of a serious allergic reaction, including: fever, swollen lymph||
2250|103|S|nodes, rash, itching/swelling (especially of the||
2250|104|S|face/tongue/throat), severe dizziness, trouble breathing.||
2250|105|S|   This is not a complete list of possible side effects. If you||
2250|106|S|notice other effects not listed above, contact your doctor or||
2250|107|S|pharmacist.||
2250|108|S|   In the US -||
2250|109|S|   Call your doctor for medical advice about side effects. You||
2250|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2250|111|S|www.fda.gov/medwatch.||
2250|112|S|   In Canada - Call your doctor for medical advice about side||
2250|113|S|effects. You may report side effects to Health Canada at||
2250|114|S|1-866-234-2345.||
2250|115|B|||
2250|116|P|PRECAUTIONS:  Before taking omeprazole, tell your doctor or||
2250|117|P|pharmacist if you are allergic to it; or to similar drugs (such||
2250|118|P|as esomeprazole, lansoprazole, pantoprazole); or if you have any||
2250|119|P|other allergies. This product may contain inactive ingredients,||
2250|120|P|which can cause allergic reactions or other problems. Talk to||
2250|121|P|your pharmacist for more details.||
2250|122|P|   Before using this medication, tell your doctor or pharmacist||
2250|123|P|your medical history, especially of: liver disease, lupus.||
2250|124|P|   Some symptoms may actually be signs of a more serious||
2250|125|P|condition. Get medical help right away if you have: heartburn||
2250|126|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
2250|127|P|pain (especially with shortness of breath, unusual sweating),||
2250|128|P|unexplained weight loss.||
2250|129|P|   In addition, before you self-treat with this medication, get||
2250|130|P|medical help right away if you have any of these signs of a||
2250|131|P|serious condition: trouble/pain swallowing food, bloody vomit,||
2250|132|P|vomit that looks like coffee grounds, bloody/black stools,||
2250|133|P|heartburn for over 3 months, frequent chest pain, frequent||
2250|134|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
2250|135|P|pain.||
2250|136|P|   Before having surgery, tell your doctor or dentist about all||
2250|137|P|the products you use (including prescription drugs,||
2250|138|P|nonprescription drugs, and herbal products).||
2250|139|P|   Proton pump inhibitors (such as omeprazole) may increase your||
2250|140|P|risk for bone fractures, especially with longer use, higher||
2250|141|P|doses, and in older adults. Talk with your doctor or pharmacist||
2250|142|P|about ways to prevent bone loss/fracture, such as by taking||
2250|143|P|calcium (such as calcium citrate) and vitamin D supplements.||
2250|144|P|   Older adults may be more sensitive to the side effects of this||
2250|145|P|drug, especially bone loss and fractures (see above), and C.||
2250|146|P|difficile infection (see Side Effects section).||
2250|147|P|   Children may be more sensitive to the side effects of this||
2250|148|P|drug, especially fever, cough, and infections of the||
2250|149|P|nose/throat/airways.||
2250|150|P|   During pregnancy, this medication should be used only when||
2250|151|P|clearly needed. Discuss the risks and benefits with your doctor.||
2250|152|P|   This medication passes into breast milk. The effects on a||
2250|153|P|nursing infant are unknown. Consult your doctor before||
2250|154|P|breastfeeding.||
2250|155|B|||
2250|156|I|DRUG INTERACTIONS:  See also How to Use section.||
2250|157|I|   Drug interactions may change how your medications work or||
2250|158|I|increase your risk for serious side effects. This document does||
2250|159|I|not contain all possible drug interactions. Keep a list of all||
2250|160|I|the products you use (including prescription/nonprescription||
2250|161|I|drugs and herbal products) and share it with your doctor and||
2250|162|I|pharmacist. Do not start, stop, or change the dosage of any||
2250|163|I|medicines without your doctor's approval.||
2250|164|I|   Some products that may interact with this drug include:||
2250|165|I|clopidogrel, methotrexate (especially high-dose treatment),||
2250|166|I|rifampin, St John's wort.||
2250|167|I|   Some products need stomach acid so that the body can absorb||
2250|168|I|them properly. Omeprazole decreases stomach acid, so it may||
2250|169|I|change how well these products work. Some affected products||
2250|170|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
2250|171|I|pazopanib, rilpivirine, sparsentan, certain azole antifungals||
2250|172|I|(itraconazole, ketoconazole, posaconazole), among others.||
2250|173|I|   Omeprazole is very similar to esomeprazole. Do not use any||
2250|174|I|medications containing esomeprazole while using omeprazole.||
2250|175|I|   This medication may interfere with certain lab tests, possibly||
2250|176|I|causing false test results. Make sure lab personnel and all your||
2250|177|I|doctors know you use this drug.||
2250|178|B|||
2250|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2250|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2250|181|O|poison control center right away. US residents can call||
2250|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2250|183|O|Symptoms of overdose may include: confusion, unusual sweating,||
2250|184|O|blurred vision, unusually fast heartbeat.||
2250|185|B|||
2250|186|N|NOTES:  If your doctor has prescribed this medication for you, do||
2250|187|N|not share it with others.||
2250|188|N|   If your doctor instructs you to use this medication regularly||
2250|189|N|for a long time, lab and/or medical tests (such as a magnesium||
2250|190|N|blood test, vitamin B-12 levels) may be done while you are taking||
2250|191|N|this medication. Keep all medical and lab appointments. Consult||
2250|192|N|your doctor for more details.||
2250|193|B|||
2250|194|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2250|195|D|remember. If it is near the time of the next dose, skip the||
2250|196|D|missed dose. Take your next dose at the regular time. Do not||
2250|197|D|double the dose to catch up.||
2250|198|B|||
2250|199|R|STORAGE:  Store at room temperature away from light and moisture.||
2250|200|R|Do not store in the bathroom. Keep all medications away from||
2250|201|R|children and pets.||
2250|202|R|   Do not flush medications down the toilet or pour them into a||
2250|203|R|drain unless instructed to do so. Properly discard this product||
2250|204|R|when it is expired or no longer needed. Consult your pharmacist||
2250|205|R|or local waste disposal company.||
2250|206|B|||
2250|207|A|Information last revised July 2025.||
2250|208|A|Copyright(c) 2025 First Databank, Inc.||
2250|209|B|||
2251|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2251|002|Z|does NOT have all possible information about this product. This||
2251|003|Z|information does not assure that this product is safe, effective,||
2251|004|Z|or appropriate for you. This information is not individual||
2251|005|Z|medical advice and does not substitute for the advice of your||
2251|006|Z|health care professional. Always ask your health care||
2251|007|Z|professional for complete information about this product and your||
2251|008|Z|specific health needs.||
2251|009|B|||
2251|010|T|FOSFOMYCIN - INJECTION||
2251|011|F|(FOS-foe-MYE-sin)||
2251|012|B|||
2251|013|U|USES:  This medication is used to treat a wide variety of||
2251|014|U|bacterial infections. It works by stopping the growth of||
2251|015|U|bacteria.||
2251|016|B|||
2251|017|H|HOW TO USE:  This medication is given by injection into a vein as||
2251|018|H|directed by your doctor, usually 2 to 4 times daily. Depending on||
2251|019|H|your dose, this medication is given over 15 to 60 minutes. The||
2251|020|H|dosage is based on your medical condition and response to||
2251|021|H|treatment. Children's dosage is also based on age and weight.||
2251|022|H|   If you are using this medication at home, learn all||
2251|023|H|preparation and usage instructions from your health care||
2251|024|H|professional. Before using, check this product for particles or||
2251|025|H|discoloration. If either is present, do not use the liquid. Learn||
2251|026|H|how to store and discard medical supplies safely.||
2251|027|H|   For the best effect, use this antibiotic at evenly spaced||
2251|028|H|times. To help you remember, use this medication at the same||
2251|029|H|times every day.||
2251|030|H|   Continue to use this medication until the full prescribed||
2251|031|H|treatment period is finished, even if symptoms disappear after a||
2251|032|H|few days. Stopping the medication too early may result in a||
2251|033|H|return of the infection.||
2251|034|H|   Tell your doctor if your condition lasts or gets worse.||
2251|035|B|||
2251|036|S|SIDE EFFECTS:  Swelling, redness, or pain at the injection site||
2251|037|S|may occur. Nausea or stomach upset may also occur. If any of||
2251|038|S|these effects last or get worse, tell your doctor or pharmacist||
2251|039|S|promptly.||
2251|040|S|   Remember that this medication has been prescribed because your||
2251|041|S|doctor has judged that the benefit to you is greater than the||
2251|042|S|risk of side effects. Many people using this medication do not||
2251|043|S|have serious side effects.||
2251|044|S|   Tell your doctor right away if you have any serious side||
2251|045|S|effects, including: signs of liver disease (such as||
2251|046|S|nausea/vomiting that doesn't stop, loss of appetite,||
2251|047|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2251|048|S|mental/mood changes, unusual weakness, muscle cramps,||
2251|049|S|fast/irregular heartbeat, unusual tiredness, swelling||
2251|050|S|ankles/feet.||
2251|051|S|   This medication may rarely cause a severe intestinal condition||
2251|052|S|due to a bacteria called C. difficile. This condition may occur||
2251|053|S|during treatment or weeks to months after treatment has stopped.||
2251|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2251|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2251|056|S|stool.||
2251|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2251|058|S|products because they may make symptoms worse.||
2251|059|S|   This medication may sometimes cause oral thrush or a new yeast||
2251|060|S|infection. Contact your doctor if you notice white patches in||
2251|061|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2251|062|S|   A very serious allergic reaction to this drug is rare.||
2251|063|S|However, get medical help right away if you notice any symptoms||
2251|064|S|of a serious allergic reaction, including: rash, itching/swelling||
2251|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2251|066|S|breathing.||
2251|067|S|   This is not a complete list of possible side effects. If you||
2251|068|S|notice other effects not listed above, contact your doctor or||
2251|069|S|pharmacist.||
2251|070|S|   In the US -||
2251|071|S|   Call your doctor for medical advice about side effects. You||
2251|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2251|073|S|www.fda.gov/medwatch.||
2251|074|S|   In Canada - Call your doctor for medical advice about side||
2251|075|S|effects. You may report side effects to Health Canada at||
2251|076|S|1-866-234-2345.||
2251|077|B|||
2251|078|P|PRECAUTIONS:  Before using fosfomycin, tell your doctor or||
2251|079|P|pharmacist if you are allergic to it; or if you have any other||
2251|080|P|allergies. This product may contain inactive ingredients, which||
2251|081|P|can cause allergic reactions or other problems. Talk to your||
2251|082|P|pharmacist for more details.||
2251|083|P|   Before using this medication, tell your doctor or pharmacist||
2251|084|P|your medical history, especially of: kidney disease, liver||
2251|085|P|disease, high levels of sodium in the blood, stomach/intestinal||
2251|086|P|diseases (such as colitis).||
2251|087|P|   This medication contains sodium. You should be on a||
2251|088|P|salt-restricted diet during treatment with this medication.||
2251|089|P|Consult your doctor or pharmacist if you have a condition that||
2251|090|P|could be worsened by an increase in salt intake (such as heart||
2251|091|P|failure, high blood pressure).||
2251|092|P|   This medication may cause live bacterial vaccines (such as||
2251|093|P|typhoid vaccine) to not work well. Tell your health care||
2251|094|P|professional that you are using this medication before having any||
2251|095|P|immunizations/vaccinations.||
2251|096|P|   Before having surgery, tell your doctor or dentist about all||
2251|097|P|the products you use (including prescription drugs,||
2251|098|P|nonprescription drugs, and herbal products).||
2251|099|P|   During pregnancy, this medication should be used only when||
2251|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
2251|101|P|   This drug passes into breast milk in small amounts, but is||
2251|102|P|unlikely to harm a nursing infant. Consult your doctor before||
2251|103|P|breastfeeding.||
2251|104|B|||
2251|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2251|106|I|medications work or increase your risk for serious side effects.||
2251|107|I|This document does not contain all possible drug interactions.||
2251|108|I|Keep a list of all the products you use (including||
2251|109|I|prescription/nonprescription drugs and herbal products) and share||
2251|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
2251|111|I|the dosage of any medicines without your doctor's approval.||
2251|112|B|||
2251|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2251|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2251|115|O|poison control center right away. US residents can call||
2251|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2251|117|O|Symptoms of overdose may include: seizures, easy||
2251|118|O|bleeding/bruising.||
2251|119|B|||
2251|120|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2251|121|N|kidney/liver function, blood mineral levels including sodium and||
2251|122|N|potassium) should be done while you are using this medication.||
2251|123|N|Keep all medical and lab appointments. Consult your doctor for||
2251|124|N|more details.||
2251|125|B|||
2251|126|D|MISSED DOSE:  It is important to get each dose of this medication||
2251|127|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2251|128|D|right away for a new dosing schedule. Do not double the dose to||
2251|129|D|catch up.||
2251|130|B|||
2251|131|R|STORAGE:  Consult the product instructions and your pharmacist||
2251|132|R|for storage details. Keep all medications away from children and||
2251|133|R|pets.||
2251|134|R|   Do not flush medications down the toilet or pour them into a||
2251|135|R|drain unless instructed to do so. Properly discard this product||
2251|136|R|when it is expired or no longer needed. Consult your pharmacist||
2251|137|R|or local waste disposal company.||
2251|138|B|||
2251|139|A|Information last revised November 2024.||
2251|140|A|Copyright(c) 2025 First Databank, Inc.||
2251|141|B|||
2254|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2254|002|Z|does NOT have all possible information about this product. This||
2254|003|Z|information does not assure that this product is safe, effective,||
2254|004|Z|or appropriate for you. This information is not individual||
2254|005|Z|medical advice and does not substitute for the advice of your||
2254|006|Z|health care professional. Always ask your health care||
2254|007|Z|professional for complete information about this product and your||
2254|008|Z|specific health needs.||
2254|009|B|||
2254|010|T|PERTUZUMAB/TRASTUZUMAB/HYALURONIDASE - SUBCUTANEOUS INJECTION||
2254|011|F|(per-TOOZ-ue-mab/tras-TOOZ-ue-mab/HYE-al-ure-ON-i-dase)||
2254|012|B|||
2254|013|C|COMMON BRAND NAME(S): Phesgo||
2254|014|B|||
2254|015|W|WARNING:  This medication may cause serious heart problems,||
2254|016|W|including heart failure. The risk of heart problems is increased||
2254|017|W|if you also use an anthracycline (such as doxorubicin). Your||
2254|018|W|doctor may stop treatment with this medication if heart problems||
2254|019|W|occur. Tell your doctor right away if you have any symptoms of||
2254|020|W|heart failure (such as shortness of breath, swelling ankles/feet,||
2254|021|W|unusual tiredness, unusual/sudden weight gain).||
2254|022|W|   This medication can cause serious (possibly fatal) harm to an||
2254|023|W|unborn baby if used during pregnancy. Your doctor should order a||
2254|024|W|pregnancy test before you start this medication. It is important||
2254|025|W|to prevent pregnancy while taking this medication. Consult your||
2254|026|W|doctor for more details and to discuss the use of reliable forms||
2254|027|W|of birth control while using this medication and for 7 months||
2254|028|W|after the last dose. If you are planning pregnancy, become||
2254|029|W|pregnant, or think you may be pregnant, tell your doctor right||
2254|030|W|away.||
2254|031|W|   Serious (possibly fatal) breathing problems may happen with||
2254|032|W|your injection. Get medical help right away if you have coughing||
2254|033|W|or trouble breathing.||
2254|034|B|||
2254|035|U|USES:  This product contains 3 ingredients: pertuzumab,||
2254|036|U|trastuzumab, and hyaluronidase. It is used to treat breast||
2254|037|U|cancer. Pertuzumab and trastuzumab belong to a class of||
2254|038|U|medications known as monoclonal antibodies. These medications||
2254|039|U|work by slowing or stopping the growth of cancer cells. This||
2254|040|U|product also contains hyaluronidase, which helps your body absorb||
2254|041|U|pertuzumab and trastuzumab given by injection under the skin.||
2254|042|B|||
2254|043|H|HOW TO USE:  This medication is given by slow injection (over||
2254|044|H|about 5 to 8 minutes) under the skin by a health care||
2254|045|H|professional. It is given as directed by your doctor in the||
2254|046|H|thigh, usually once every 3 weeks. The injection site and side||
2254|047|H|should be changed each time to lessen injury under the skin. The||
2254|048|H|dosage and length of treatment are based on your medical||
2254|049|H|condition and response to treatment.||
2254|050|H|   Use this medication regularly to get the most benefit from it.||
2254|051|H|To help you remember, mark your calendar with a reminder.||
2254|052|H|   Serious injection reactions, including an allergic reaction,||
2254|053|H|may happen during the injection of this drug and for a short time||
2254|054|H|afterward. Your doctor may prescribe other medications (such as||
2254|055|H|acetaminophen, diphenhydramine) before each treatment to help||
2254|056|H|prevent these serious side effects. Get medical help right away||
2254|057|H|if you have any symptoms of an injection or allergic reaction||
2254|058|H|such as fever, chills, flushing, headache, nausea/vomiting,||
2254|059|H|coughing, chest pain, trouble breathing, itching/swelling||
2254|060|H|(especially of the face/tongue/throat), dizziness, weakness, or||
2254|061|H|feeling faint.||
2254|062|B|||
2254|063|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2254|064|S|   Redness/irritation/pain at the injection site, nausea,||
2254|065|S|vomiting, diarrhea or constipation, dizziness, tiredness,||
2254|066|S|weakness, trouble sleeping, muscle/joint/back pain,||
2254|067|S|stomach/abdominal pain, changes in how food tastes, and loss of||
2254|068|S|appetite may occur. Pain or sores in the mouth and throat may||
2254|069|S|occur. Brush your teeth carefully/gently, avoid using mouthwash||
2254|070|S|that contains alcohol, and rinse your mouth often with cool water||
2254|071|S|mixed with baking soda or salt. It may also be best to eat soft,||
2254|072|S|moist foods. Nausea and vomiting can be severe. In some cases,||
2254|073|S|your doctor may prescribe medication to prevent or relieve nausea||
2254|074|S|and vomiting. Eating several small meals, not eating before||
2254|075|S|treatment, or limiting activity may help lessen some of these||
2254|076|S|effects. If any of these effects last or get worse, tell your||
2254|077|S|doctor or pharmacist promptly.||
2254|078|S|   Temporary hair loss may occur. Normal hair growth should||
2254|079|S|return after treatment has ended.||
2254|080|S|   People using this medication may have serious side effects.||
2254|081|S|However, you have been prescribed this drug because your doctor||
2254|082|S|has judged that the benefit to you is greater than the risk of||
2254|083|S|side effects. Careful monitoring by your doctor may decrease your||
2254|084|S|risk.||
2254|085|S|   Tell your doctor right away if you have any serious side||
2254|086|S|effects, including: easy bruising/bleeding, bone pain,||
2254|087|S|numbness/tingling, mental/mood changes.||
2254|088|S|   This medication may lower your ability to fight infections.||
2254|089|S|This may make you more likely to get a serious (rarely fatal)||
2254|090|S|infection or make any infection you have worse. Tell your doctor||
2254|091|S|right away if you have any signs of infection (such as sore||
2254|092|S|throat that doesn't go away, fever, chills).||
2254|093|S|   This medication can commonly cause a rash that is usually not||
2254|094|S|serious. However, you may not be able to tell it apart from a||
2254|095|S|rare rash that could be a sign of a severe reaction. Tell your||
2254|096|S|doctor right away if you develop any rash.||
2254|097|S|   A very serious allergic reaction to this drug is rare.||
2254|098|S|However, get medical help right away if you notice any symptoms||
2254|099|S|of a serious allergic reaction, including: rash, itching/swelling||
2254|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2254|101|S|breathing.||
2254|102|S|   This is not a complete list of possible side effects. If you||
2254|103|S|notice other effects not listed above, contact your doctor or||
2254|104|S|pharmacist.||
2254|105|S|   In the US -||
2254|106|S|   Call your doctor for medical advice about side effects. You||
2254|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2254|108|S|www.fda.gov/medwatch.||
2254|109|S|   In Canada - Call your doctor for medical advice about side||
2254|110|S|effects. You may report side effects to Health Canada at||
2254|111|S|1-866-234-2345.||
2254|112|B|||
2254|113|P|PRECAUTIONS:  See also Warning section.||
2254|114|P|   Before using this product, tell your doctor or pharmacist if||
2254|115|P|you are allergic to pertuzumab, trastuzumab, or hyaluronidase; or||
2254|116|P|to any trastuzumab deruxtecan, or trastuzumab emtansine products;||
2254|117|P|or if you have any other allergies. This product may contain||
2254|118|P|inactive ingredients, which can cause allergic reactions or other||
2254|119|P|problems. Talk to your pharmacist for more details.||
2254|120|P|   Before using this medication, tell your doctor or pharmacist||
2254|121|P|your medical history, especially of: current/recent infection,||
2254|122|P|heart problems (such as heart failure, irregular heartbeat), high||
2254|123|P|blood pressure, lung problems, previous cancer treatments||
2254|124|P|(including radiation treatment).||
2254|125|P|   This medication can make you more likely to get infections or||
2254|126|P|may make current infections worse. Stay away from anyone who has||
2254|127|P|an infection that may easily spread (such as chickenpox,||
2254|128|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2254|129|P|exposed to an infection or for more details.||
2254|130|P|   Tell your health care professional that you are using this||
2254|131|P|medication before having any immunizations/vaccinations. Avoid||
2254|132|P|contact with people who have recently received live vaccines||
2254|133|P|(such as flu vaccine inhaled through the nose).||
2254|134|P|   To lower the chance of getting cut, bruised, or injured, use||
2254|135|P|caution with sharp objects like razors and nail cutters, and||
2254|136|P|avoid activities such as contact sports.||
2254|137|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2254|138|P|can make you more dizzy. Do not drive, use machinery, or do||
2254|139|P|anything that needs alertness until you can do it safely. Limit||
2254|140|P|alcoholic beverages. Talk to your doctor if you are using||
2254|141|P|marijuana (cannabis).||
2254|142|P|   Before having surgery, tell your doctor or dentist about all||
2254|143|P|the products you use (including prescription drugs,||
2254|144|P|nonprescription drugs, and herbal products).||
2254|145|P|   Older adults may be at greater risk for loss of appetite,||
2254|146|P|anemia, numbness/tingling, changes in how food tastes, or heart||
2254|147|P|problems (such as heart failure) while using this drug.||
2254|148|P|   Tell your doctor if you are pregnant or plan to become||
2254|149|P|pregnant. You should not become pregnant while using this||
2254|150|P|medication. This medication may harm an unborn baby.||
2254|151|P|   It is unknown if this drug passes into breast milk. Consult||
2254|152|P|your doctor before breastfeeding while using this medication and||
2254|153|P|for 7 months after stopping treatment.||
2254|154|B|||
2254|155|I|DRUG INTERACTIONS:  See also Warning section.||
2254|156|I|   Drug interactions may change how your medications work or||
2254|157|I|increase your risk for serious side effects. This document does||
2254|158|I|not contain all possible drug interactions. Keep a list of all||
2254|159|I|the products you use (including prescription/nonprescription||
2254|160|I|drugs and herbal products) and share it with your doctor and||
2254|161|I|pharmacist. Do not start, stop, or change the dosage of any||
2254|162|I|medicines without your doctor's approval.||
2254|163|I|   Trastuzumab is very similar to trastuzumab deruxtecan and||
2254|164|I|trastuzumab emtansine. Do not use a trastuzumab deruxtecan or||
2254|165|I|trastuzumab emtansine product while using a trastuzumab product.||
2254|166|B|||
2254|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2254|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2254|169|O|poison control center right away. US residents can call||
2254|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2254|171|B|||
2254|172|N|NOTES:  Lab and/or medical tests (such as heart exams, complete||
2254|173|N|blood count, blood pressure) should be done before you start||
2254|174|N|using this medication and while you are using it. Heart exams||
2254|175|N|should also be done every 6 months for at least 2 years after the||
2254|176|N|last dose. Keep all medical and lab appointments.||
2254|177|B|||
2254|178|D|MISSED DOSE:  It is important to get each dose of this medication||
2254|179|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2254|180|D|right away for a new dosing schedule.||
2254|181|B|||
2254|182|R|STORAGE:  Not applicable. This medication is given in a hospital||
2254|183|R|or clinic and will not be stored at home.||
2254|184|B|||
2254|185|M|MEDICAL ALERT:  Your condition can cause complications in a||
2254|186|M|medical emergency. For information about enrolling in MedicAlert,||
2254|187|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2254|188|B|||
2254|189|A|Information last revised April 2025.||
2254|190|A|Copyright(c) 2025 First Databank, Inc.||
2254|191|B|||
2255|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2255|002|Z|does NOT have all possible information about this product. This||
2255|003|Z|information does not assure that this product is safe, effective,||
2255|004|Z|or appropriate for you. This information is not individual||
2255|005|Z|medical advice and does not substitute for the advice of your||
2255|006|Z|health care professional. Always ask your health care||
2255|007|Z|professional for complete information about this product and your||
2255|008|Z|specific health needs.||
2255|009|B|||
2255|010|T|FOSTEMSAVIR EXTENDED-RELEASE - ORAL||
2255|011|F|(fos-TEM-sa-vir)||
2255|012|B|||
2255|013|C|COMMON BRAND NAME(S): Rukobia||
2255|014|B|||
2255|015|U|USES:  This drug is used with other HIV medications to help||
2255|016|U|control HIV infection. It helps to decrease the amount of HIV in||
2255|017|U|your body so your immune system can work better. This lowers your||
2255|018|U|chance of getting HIV complications (such as new infections,||
2255|019|U|cancer) and improves your quality of life. Fostemsavir is changed||
2255|020|U|in your body to its active drug form. It works by helping to||
2255|021|U|prevent attachment of and entry of the (HIV-1) virus into healthy||
2255|022|U|cells in your body.||
2255|023|U|   Fostemsavir is not a cure for HIV infection. To decrease your||
2255|024|U|risk of spreading HIV disease to others, continue to take all HIV||
2255|025|U|medications exactly as prescribed by your doctor. Use an||
2255|026|U|effective barrier method (latex or polyurethane condoms/dental||
2255|027|U|dams) during sexual activity as directed by your doctor. Do not||
2255|028|U|share personal items (such as needles/syringes, toothbrushes, and||
2255|029|U|razors) that may have contacted blood or other body fluids.||
2255|030|U|Consult your doctor or pharmacist for more details.||
2255|031|B|||
2255|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2255|033|H|from your pharmacist before you start taking fostemsavir and each||
2255|034|H|time you get a refill. If you have any questions, ask your doctor||
2255|035|H|or pharmacist.||
2255|036|H|   Take this medication by mouth with or without food as directed||
2255|037|H|by your doctor, usually twice daily. Swallow the tablets whole.||
2255|038|H|Do not chew, crush, or split the tablets. Doing so can release||
2255|039|H|all of the drug at once, increasing the risk of side effects. The||
2255|040|H|dosage is based on your medical condition and response to||
2255|041|H|treatment.||
2255|042|H|   You may smell a slight odor (like vinegar) from the tablets.||
2255|043|H|This is normal.||
2255|044|H|   It is very important to keep taking this medication (and other||
2255|045|H|HIV medications) exactly as prescribed by your doctor. Do not||
2255|046|H|skip any doses.||
2255|047|H|   For the best effect, take this medication regularly. To help||
2255|048|H|you remember, take this medication at the same times every day.||
2255|049|H|   Do not take more or less of this drug than prescribed or stop||
2255|050|H|taking it (or other HIV medicines) even for a short time unless||
2255|051|H|directed to do so by your doctor. Doing so may cause the amount||
2255|052|H|of virus to increase, make the infection more difficult to treat||
2255|053|H|(resistant), or worsen side effects.||
2255|054|B|||
2255|055|S|SIDE EFFECTS:  Nausea or drowsiness may occur. If either of these||
2255|056|S|effects lasts or gets worse, tell your doctor or pharmacist||
2255|057|S|promptly.||
2255|058|S|   Remember that this medication has been prescribed because your||
2255|059|S|doctor has judged that the benefit to you is greater than the||
2255|060|S|risk of side effects. Many people using this medication do not||
2255|061|S|have serious side effects.||
2255|062|S|   As your immune system gets stronger, it can begin to fight off||
2255|063|S|infections you already had, possibly causing disease symptoms to||
2255|064|S|come back. You could also have symptoms if your immune system||
2255|065|S|becomes overactive. This reaction may happen at any time (soon||
2255|066|S|after starting HIV treatment or many months later). Tell your||
2255|067|S|doctor right away if you have any serious symptoms, including:||
2255|068|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
2255|069|S|that doesn't go away, headaches that are severe or don't go away,||
2255|070|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
2255|071|S|changes, signs of infection (such as sore throat that doesn't go||
2255|072|S|away, fever, chills, swollen lymph nodes, non-healing skin||
2255|073|S|sores), signs of an overactive thyroid (such as irritability,||
2255|074|S|nervousness, heat intolerance, fast/pounding/irregular||
2255|075|S|heartbeat), signs of liver disease (such as nausea/vomiting that||
2255|076|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
2255|077|S|eyes/skin, dark urine).||
2255|078|S|   Get medical help right away if you have any very serious side||
2255|079|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2255|080|S|fainting.||
2255|081|S|   A very serious allergic reaction to this drug is rare.||
2255|082|S|However, get medical help right away if you notice any symptoms||
2255|083|S|of a serious allergic reaction, including: rash, itching/swelling||
2255|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2255|085|S|breathing.||
2255|086|S|   This is not a complete list of possible side effects. If you||
2255|087|S|notice other effects not listed above, contact your doctor or||
2255|088|S|pharmacist.||
2255|089|S|   In the US -||
2255|090|S|   Call your doctor for medical advice about side effects. You||
2255|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2255|092|S|www.fda.gov/medwatch.||
2255|093|S|   In Canada - Call your doctor for medical advice about side||
2255|094|S|effects. You may report side effects to Health Canada at||
2255|095|S|1-866-234-2345.||
2255|096|B|||
2255|097|P|PRECAUTIONS:  Before taking fostemsavir, tell your doctor or||
2255|098|P|pharmacist if you are allergic to it; or if you have any other||
2255|099|P|allergies. This product may contain inactive ingredients, which||
2255|100|P|can cause allergic reactions or other problems. Talk to your||
2255|101|P|pharmacist for more details.||
2255|102|P|   Before using this medication, tell your doctor or pharmacist||
2255|103|P|your medical history, especially of: liver problems (especially||
2255|104|P|hepatitis B, hepatitis C infection).||
2255|105|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
2255|106|P|can make you more drowsy. Do not drive, use machinery, or do||
2255|107|P|anything that needs alertness until you can do it safely. Limit||
2255|108|P|alcoholic beverages. Talk to your doctor if you are using||
2255|109|P|marijuana (cannabis).||
2255|110|P|   Fostemsavir may cause a condition that affects the heart||
2255|111|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2255|112|P|serious (rarely fatal) fast/irregular heartbeat and other||
2255|113|P|symptoms (such as severe dizziness, fainting) that need medical||
2255|114|P|attention right away.||
2255|115|P|   The risk of QT prolongation may be increased if you have||
2255|116|P|certain medical conditions or are taking other drugs that may||
2255|117|P|cause QT prolongation. Before using fostemsavir, tell your doctor||
2255|118|P|or pharmacist of all the drugs you take and if you have any of||
2255|119|P|the following conditions: certain heart problems (heart failure,||
2255|120|P|slow heartbeat, QT prolongation in the EKG), family history of||
2255|121|P|certain heart problems (QT prolongation in the EKG, sudden||
2255|122|P|cardiac death).||
2255|123|P|   Low levels of potassium or magnesium in the blood may also||
2255|124|P|increase your risk of QT prolongation. This risk may increase if||
2255|125|P|you use certain drugs (such as diuretics/"water pills") or if you||
2255|126|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2255|127|P|Talk to your doctor about using fostemsavir safely.||
2255|128|P|   Before having surgery, tell your doctor or dentist about all||
2255|129|P|the products you use (including prescription drugs,||
2255|130|P|nonprescription drugs, and herbal products).||
2255|131|P|   Older adults may be more sensitive to the side effects of this||
2255|132|P|drug, especially QT prolongation (see above).||
2255|133|P|   During pregnancy, this medication should be used only when||
2255|134|P|clearly needed. Treatment can lower the risk of passing HIV||
2255|135|P|infection to your baby, and fostemsavir may be part of that||
2255|136|P|treatment. Discuss the risks and benefits with your doctor.||
2255|137|P|   It is unknown if this medication passes into breast milk.||
2255|138|P|Because breast milk may transmit HIV, consult your doctor before||
2255|139|P|breastfeeding.||
2255|140|B|||
2255|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2255|142|I|medications work or increase your risk for serious side effects.||
2255|143|I|This document does not contain all possible drug interactions.||
2255|144|I|Keep a list of all the products you use (including||
2255|145|I|prescription/nonprescription drugs and herbal products) and share||
2255|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
2255|147|I|the dosage of any medicines without your doctor's approval.||
2255|148|I|   Other medications can affect the removal of fostemsavir from||
2255|149|I|your body, which may affect how fostemsavir works. Examples||
2255|150|I|include apalutamide, butalbital, enzalutamide, lumacaftor,||
2255|151|I|mitotane, rifamycins (such as rifampin, rifapentine),||
2255|152|I|secobarbital, St. John's wort, drugs used to treat seizures (such||
2255|153|I|as carbamazepine, fosphenytoin, phenytoin), among others.||
2255|154|I|   This medication can slow down the removal of other medications||
2255|155|I|from your body, which may affect how they work. Examples of||
2255|156|I|affected drugs include grazoprevir, voxilaprevir, among others.||
2255|157|B|||
2255|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2255|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2255|160|O|poison control center right away. US residents can call||
2255|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2255|162|B|||
2255|163|N|NOTES:  Do not share this medication with others.||
2255|164|N|   Lab and/or medical tests (such as viral load, T-cell counts,||
2255|165|N|liver function) should be done while you are taking this||
2255|166|N|medication. Keep all medical and lab appointments.||
2255|167|B|||
2255|168|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2255|169|D|remember. If it is near the time of the next dose, skip the||
2255|170|D|missed dose. Take your next dose at the regular time. Do not||
2255|171|D|double the dose to catch up.||
2255|172|B|||
2255|173|R|STORAGE:  Store at room temperature away from light and moisture.||
2255|174|R|Do not store in the bathroom. Keep all medications away from||
2255|175|R|children and pets.||
2255|176|R|   Do not flush medications down the toilet or pour them into a||
2255|177|R|drain unless instructed to do so. Properly discard this product||
2255|178|R|when it is expired or no longer needed. Consult your pharmacist||
2255|179|R|or local waste disposal company.||
2255|180|B|||
2255|181|A|Information last revised April 2025.||
2255|182|A|Copyright(c) 2025 First Databank, Inc.||
2255|183|B|||
2257|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2257|002|Z|does NOT have all possible information about this product. This||
2257|003|Z|information does not assure that this product is safe, effective,||
2257|004|Z|or appropriate for you. This information is not individual||
2257|005|Z|medical advice and does not substitute for the advice of your||
2257|006|Z|health care professional. Always ask your health care||
2257|007|Z|professional for complete information about this product and your||
2257|008|Z|specific health needs.||
2257|009|B|||
2257|010|T|BREXUCABTAGENE AUTOLEUCEL - INJECTION||
2257|011|F|(BREX-ue-KAB-ta-geen AW-toe-LOO-sel)||
2257|012|B|||
2257|013|C|COMMON BRAND NAME(S): Tecartus||
2257|014|B|||
2257|015|W|WARNING:  This medication may cause a serious (even fatal)||
2257|016|W|reaction called cytokine release syndrome-CRS. Careful monitoring||
2257|017|W|and prompt treatment may decrease your risk. Before treatment||
2257|018|W|with this medication, tell your doctor your medical history,||
2257|019|W|especially of any current/recent infection. Tell your doctor||
2257|020|W|right away if you have any symptoms of CRS such as high fever,||
2257|021|W|trouble breathing, chills/shaking chills, severe||
2257|022|W|nausea/vomiting/diarrhea, severe muscle/joint pain, very low||
2257|023|W|blood pressure, dizziness/lightheadedness.||
2257|024|W|   Serious nerve problems can occur after treatment with||
2257|025|W|brexucabtagene autoleucel. Tell your doctor right away if you||
2257|026|W|have drowsiness, seizure(s), mental/mood changes (such as||
2257|027|W|confusion, anxiety, memory loss), or trouble with reading,||
2257|028|W|writing, speaking, or understanding.||
2257|029|B|||
2257|030|U|USES:  Brexucabtagene autoleucel is used to treat certain types||
2257|031|U|of cancers (mantle cell lymphoma, acute lymphoblastic leukemia)||
2257|032|U|that have not gotten better or that have come back after other||
2257|033|U|kinds of treatment. This type of treatment is known as gene||
2257|034|U|therapy. Brexucabtagene autoleucel is made from your own white||
2257|035|U|blood cells and is given only to you. The white blood cells have||
2257|036|U|been changed to have a specific protein (chimeric antigen||
2257|037|U|receptor-CAR) that helps your body slow or stop the growth of||
2257|038|U|certain cancer cells.||
2257|039|B|||
2257|040|H|HOW TO USE:  Read the Medication Guide provided by your||
2257|041|H|healthcare professional before you start using this product. If||
2257|042|H|you have any questions, ask your healthcare professionals.||
2257|043|H|   Your doctor may give you 3 days of chemotherapy before||
2257|044|H|treatment with this product to prepare your body.||
2257|045|H|   This product is given by slow injection into a vein as||
2257|046|H|directed by your doctor, usually over less than 30 minutes. To||
2257|047|H|decrease the risk of side effects, your doctor may also give you||
2257|048|H|other medications (such as acetaminophen, diphenhydramine) before||
2257|049|H|injecting brexucabtagene autoleucel. The dosage is based on your||
2257|050|H|medical condition and weight.||
2257|051|H|   Your doctor will check you daily for at least 7 days after||
2257|052|H|your treatment to see how well it works and help you manage any||
2257|053|H|side effects. You should plan to stay for at least 2 weeks near||
2257|054|H|the place of your treatment (for example, within 2 hours' drive).||
2257|055|B|||
2257|056|S|SIDE EFFECTS:  See also Warning section.||
2257|057|S|   Headache, tiredness, trouble sleeping, or loss of appetite may||
2257|058|S|occur. If any of these effects last or get worse, tell your||
2257|059|S|doctor or pharmacist promptly.||
2257|060|S|   People using this medication may have serious side effects.||
2257|061|S|However, you have been prescribed this drug because your doctor||
2257|062|S|has judged that the benefit to you is greater than the risk of||
2257|063|S|side effects. Careful monitoring by your doctor may decrease your||
2257|064|S|risk.||
2257|065|S|   Tell your doctor right away if you have any serious side||
2257|066|S|effects, including: fast/irregular heartbeat, signs of kidney||
2257|067|S|problems (such as change in the amount of urine).||
2257|068|S|   Although brexucabtagene autoleucel is used to treat cancer, it||
2257|069|S|may rarely increase your risk of developing other cancers. Also,||
2257|070|S|this product may cause a severe decrease in your blood cells,||
2257|071|S|which lowers your ability to fight infections and increases the||
2257|072|S|risk of anemia/bleeding problems. You may be more likely to get a||
2257|073|S|serious (rarely fatal) infection and any infection you have may||
2257|074|S|get worse. Tell your doctor right away if you develop unusual||
2257|075|S|growths or lumps, swollen lymph nodes, signs of infection (such||
2257|076|S|as sore throat that doesn't go away, fever, chills), easy or||
2257|077|S|unusual bruising/bleeding, or unusual tiredness.||
2257|078|S|   A very serious allergic reaction to this drug is rare.||
2257|079|S|However, get medical help right away if you notice any symptoms||
2257|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2257|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2257|082|S|breathing.||
2257|083|S|   This is not a complete list of possible side effects. If you||
2257|084|S|notice other effects not listed above, contact your doctor or||
2257|085|S|pharmacist.||
2257|086|S|   In the US -||
2257|087|S|   Call your doctor for medical advice about side effects. You||
2257|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2257|089|S|www.fda.gov/medwatch.||
2257|090|S|   In Canada - Call your doctor for medical advice about side||
2257|091|S|effects. You may report side effects to Health Canada at||
2257|092|S|1-866-234-2345.||
2257|093|B|||
2257|094|P|PRECAUTIONS:  Before receiving brexucabtagene autoleucel, tell||
2257|095|P|your doctor or pharmacist if you have any allergies. This product||
2257|096|P|may contain inactive ingredients, which can cause allergic||
2257|097|P|reactions or other problems. Talk to your pharmacist for more||
2257|098|P|details.||
2257|099|P|   Before using this medication, tell your doctor or pharmacist||
2257|100|P|your medical history, especially of: heart problems, kidney/liver||
2257|101|P|problems, lung or breathing problems, nerve problems (such as||
2257|102|P|memory loss, seizures), past/current/recent infection.||
2257|103|P|   This product can make you more likely to get infections or may||
2257|104|P|make current infections worse. Stay away from anyone who has an||
2257|105|P|infection that may easily spread (such as chickenpox, COVID-19,||
2257|106|P|measles, flu). Talk to your doctor if you have been exposed to an||
2257|107|P|infection or for more details.||
2257|108|P|   Tell your health care professional that you are using||
2257|109|P|brexucabtagene autoleucel before having any||
2257|110|P|immunizations/vaccinations. Avoid contact with people who have||
2257|111|P|recently received live vaccines (such as flu vaccine inhaled||
2257|112|P|through the nose).||
2257|113|P|   To lower the chance of getting cut, bruised, or injured, use||
2257|114|P|caution with sharp objects like razors and nail cutters, and||
2257|115|P|avoid activities such as contact sports.||
2257|116|P|   This drug may make you drowsy or dizzy, affect your||
2257|117|P|coordination, or make it harder for you to think clearly. Alcohol||
2257|118|P|or marijuana (cannabis) can worsen these effects. Do not drive,||
2257|119|P|use machinery, or do anything that needs alertness until you can||
2257|120|P|do it safely (at least 2 weeks after receiving treatment is||
2257|121|P|recommended by the manufacturer). Limit alcoholic beverages. Talk||
2257|122|P|to your doctor if you are using marijuana (cannabis).||
2257|123|P|   Before having surgery, tell your doctor or dentist about all||
2257|124|P|the products you use (including prescription drugs,||
2257|125|P|nonprescription drugs, and herbal products).||
2257|126|P|   Tell your doctor if you are pregnant or plan to become||
2257|127|P|pregnant. You should not become pregnant while using this||
2257|128|P|product. Brexucabtagene autoleucel may harm an unborn baby. Your||
2257|129|P|doctor should order a pregnancy test before you start this||
2257|130|P|medication. If you become pregnant, talk to your doctor right||
2257|131|P|away about the risks and benefits of this medication.||
2257|132|P|   It is unknown if this product passes into breast milk. Consult||
2257|133|P|your doctor before breastfeeding.||
2257|134|B|||
2257|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2257|136|I|medications work or increase your risk for serious side effects.||
2257|137|I|This document does not contain all possible drug interactions.||
2257|138|I|Keep a list of all the products you use (including||
2257|139|I|prescription/nonprescription drugs and herbal products) and share||
2257|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
2257|141|I|the dosage of any medicines without your doctor's approval.||
2257|142|B|||
2257|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2257|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2257|145|O|poison control center right away. US residents can call||
2257|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2257|147|B|||
2257|148|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
2257|149|N|should be done before and after you receive this product. Keep||
2257|150|N|all medical and lab appointments.||
2257|151|N|   After receiving this treatment, do not donate blood, organs,||
2257|152|N|tissues, or cells.||
2257|153|B|||
2257|154|D|MISSED DOSE:  Not applicable.||
2257|155|B|||
2257|156|R|STORAGE:  Not applicable. This product is given in a hospital or||
2257|157|R|clinic and will not be stored at home.||
2257|158|B|||
2257|159|M|MEDICAL ALERT:  Your condition can cause complications in a||
2257|160|M|medical emergency. For information about enrolling in MedicAlert,||
2257|161|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2257|162|B|||
2257|163|A|Information last revised June 2025.||
2257|164|A|Copyright(c) 2025 First Databank, Inc.||
2257|165|B|||
2258|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2258|002|Z|does NOT have all possible information about this product. This||
2258|003|Z|information does not assure that this product is safe, effective,||
2258|004|Z|or appropriate for you. This information is not individual||
2258|005|Z|medical advice and does not substitute for the advice of your||
2258|006|Z|health care professional. Always ask your health care||
2258|007|Z|professional for complete information about this product and your||
2258|008|Z|specific health needs.||
2258|009|B|||
2258|010|T|BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL - ORAL INHALATION||
2258|011|F|(bue-DES-oh-nide/GLYE-koe-PIR-oh-late/for-MOE-ter-ol)||
2258|012|B|||
2258|013|C|COMMON BRAND NAME(S): Breztri Aerosphere||
2258|014|B|||
2258|015|U|USES:  This product is used to control and prevent symptoms (such||
2258|016|U|as wheezing and shortness of breath) caused by ongoing lung||
2258|017|U|disease (chronic obstructive pulmonary disease-COPD, which||
2258|018|U|includes chronic bronchitis and emphysema). Controlling symptoms||
2258|019|U|of breathing problems helps you maintain your normal activities||
2258|020|U|and decreases time lost from work or school. This inhaler||
2258|021|U|contains 3 medications: budesonide, glycopyrrolate, and||
2258|022|U|formoterol. Budesonide works by reducing the irritation and||
2258|023|U|swelling of the airways. Budesonide belongs to a class of drugs||
2258|024|U|known as corticosteroids. Glycopyrrolate and formoterol work by||
2258|025|U|relaxing the muscles around the airways so that they open up and||
2258|026|U|you can breathe more easily. Glycopyrrolate belongs to a class of||
2258|027|U|drugs known as anticholinergics. Formoterol belongs to the class||
2258|028|U|of drugs known as long-acting beta agonists (LABAs). Both drugs||
2258|029|U|are also known as bronchodilators.||
2258|030|U|   This medication must be used regularly to be effective. It||
2258|031|U|does not work right away and should not be used to relieve sudden||
2258|032|U|breathing problems. If sudden shortness of breath occurs, use||
2258|033|U|your quick-relief inhaler as prescribed.||
2258|034|U|   This medication is not approved to treat asthma.||
2258|035|B|||
2258|036|H|HOW TO USE:  Read the Patient Information Leaflet and||
2258|037|H|Instructions for Use if available from your pharmacist before you||
2258|038|H|start using this medication and each time you get a refill. If||
2258|039|H|you have any questions, ask your doctor or pharmacist.||
2258|040|H|   Follow the instructions for priming the inhaler if you are||
2258|041|H|using it for the first time, if you have not used it for a week||
2258|042|H|or more, if you dropped the inhaler, or if you put the canister||
2258|043|H|back into the inhaler after cleaning. When priming the inhaler,||
2258|044|H|make sure to spray away from your face so that you do not get the||
2258|045|H|medication into your eyes.||
2258|046|H|   Shake the inhaler well before using. Inhale this medication by||
2258|047|H|mouth as directed by your doctor, usually twice daily (in the||
2258|048|H|morning and in the evening). Wait at least 1 minute between||
2258|049|H|inhalations.||
2258|050|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
2258|051|H|from developing, gargle, rinse your mouth with water and spit out||
2258|052|H|after each use. Do not swallow the rinse water.||
2258|053|H|   Use this medication regularly to get the most benefit from it.||
2258|054|H|To help you remember, use it at the same times each day.||
2258|055|H|   Do not increase your dose, use this medication more often, or||
2258|056|H|stop using it without first consulting your doctor. Your||
2258|057|H|condition will not improve any faster, and your risk of side||
2258|058|H|effects will increase.||
2258|059|H|   If you are using other inhalers at the same time, wait at||
2258|060|H|least 1 minute between the use of each medication.||
2258|061|H|   If you are regularly using a different corticosteroid taken by||
2258|062|H|mouth (such as prednisone), you should not stop using it unless||
2258|063|H|directed by your doctor. You may have withdrawal symptoms if the||
2258|064|H|drug is suddenly stopped. Some conditions (such as asthma,||
2258|065|H|allergies) may become worse when the drug is suddenly stopped. To||
2258|066|H|prevent withdrawal symptoms (such as weakness, weight loss,||
2258|067|H|nausea, muscle pain, headache, tiredness, dizziness), your doctor||
2258|068|H|may direct you to slowly lower the dose of your old medication||
2258|069|H|after you begin using this product. Consult your doctor or||
2258|070|H|pharmacist for more details, and report any withdrawal reactions||
2258|071|H|right away. See also Precautions section.||
2258|072|H|   If you have been using a quick-relief inhaler (such as||
2258|073|H|albuterol, also called salbutamol in some countries) on a regular||
2258|074|H|daily schedule (such as 4 times daily), you must stop this||
2258|075|H|schedule and only use the quick-relief inhaler as needed for||
2258|076|H|sudden shortness of breath. Consult your doctor for details.||
2258|077|H|   Learn which of your inhalers you should use every day and||
2258|078|H|which you should use if your breathing suddenly worsens||
2258|079|H|(quick-relief drugs). Ask your doctor ahead of time what you||
2258|080|H|should do if you have new or worsening cough or shortness of||
2258|081|H|breath, wheezing, increased sputum, waking up at night with||
2258|082|H|trouble breathing, if you use your quick-relief inhaler more||
2258|083|H|often, or if your quick-relief inhaler does not seem to be||
2258|084|H|working well. Learn when you can treat sudden breathing problems||
2258|085|H|by yourself and when you must get medical help right away.||
2258|086|H|   Tell your doctor if your condition does not get better or if||
2258|087|H|it gets worse.||
2258|088|B|||
2258|089|S|SIDE EFFECTS:  Dry/irritated throat, hoarseness, or coughing may||
2258|090|S|occur. If any of these effects last or get worse, tell your||
2258|091|S|doctor or pharmacist promptly.||
2258|092|S|   Remember that this medication has been prescribed because your||
2258|093|S|doctor has judged that the benefit to you is greater than the||
2258|094|S|risk of side effects. Many people using this medication do not||
2258|095|S|have serious side effects.||
2258|096|S|   This medication may raise your blood pressure. Check your||
2258|097|S|blood pressure regularly and tell your doctor if the results are||
2258|098|S|high.||
2258|099|S|   Rarely, this medication may cause sudden severe||
2258|100|S|wheezing/trouble breathing right after you use it. If this||
2258|101|S|occurs, use your quick-relief inhaler and get medical help right||
2258|102|S|away.||
2258|103|S|   Tell your doctor right away if you have any serious side||
2258|104|S|effects, including: white patches on tongue/in mouth, signs of||
2258|105|S|infection (such as sore throat that doesn't go away, fever,||
2258|106|S|chills), difficult/painful urination, muscle cramps/weakness,||
2258|107|S|increased thirst/urination, bone pain, mental/mood changes (such||
2258|108|S|as nervousness), shaking (tremors).||
2258|109|S|   Get medical help right away if you have any very serious side||
2258|110|S|effects, including: chest pain, fast/irregular heartbeat, severe||
2258|111|S|dizziness, fainting, eye pain/swelling/redness, vision changes||
2258|112|S|(such as seeing rainbows around lights at night, blurred vision).||
2258|113|S|   A very serious allergic reaction to this drug is rare.||
2258|114|S|However, get medical help right away if you notice any symptoms||
2258|115|S|of a serious allergic reaction, including: rash, itching/swelling||
2258|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2258|117|S|breathing.||
2258|118|S|   This is not a complete list of possible side effects. If you||
2258|119|S|notice other effects not listed above, contact your doctor or||
2258|120|S|pharmacist.||
2258|121|S|   In the US -||
2258|122|S|   Call your doctor for medical advice about side effects. You||
2258|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2258|124|S|www.fda.gov/medwatch.||
2258|125|S|   In Canada - Call your doctor for medical advice about side||
2258|126|S|effects. You may report side effects to Health Canada at||
2258|127|S|1-866-234-2345.||
2258|128|B|||
2258|129|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2258|130|P|pharmacist if you are allergic to budesonide, glycopyrrolate, or||
2258|131|P|formoterol; or to arformoterol; or if you have any other||
2258|132|P|allergies. This product may contain inactive ingredients, which||
2258|133|P|can cause allergic reactions or other problems. Talk to your||
2258|134|P|pharmacist for more details.||
2258|135|P|   Before using this medication, tell your doctor or pharmacist||
2258|136|P|your medical history, especially of: current/past infections||
2258|137|P|(such as tuberculosis, herpes), heart problems (such as chest||
2258|138|P|pain, irregular heartbeat), high blood pressure, seizures, bone||
2258|139|P|loss (osteoporosis), eye problems (such as cataracts, glaucoma),||
2258|140|P|overactive thyroid, diabetes, difficulty urinating (such as due||
2258|141|P|to an enlarged prostate), liver disease.||
2258|142|P|   This product may cause a condition that affects the heart||
2258|143|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2258|144|P|serious (rarely fatal) fast/irregular heartbeat and other||
2258|145|P|symptoms (such as severe dizziness, fainting) that need medical||
2258|146|P|attention right away.||
2258|147|P|   The risk of QT prolongation may be increased if you have||
2258|148|P|certain medical conditions or are taking other drugs that may||
2258|149|P|cause QT prolongation. Before using this product, tell your||
2258|150|P|doctor or pharmacist of all the drugs you take and if you have||
2258|151|P|any of the following conditions: certain heart problems (heart||
2258|152|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2258|153|P|history of certain heart problems (QT prolongation in the EKG,||
2258|154|P|sudden cardiac death).||
2258|155|P|   Low levels of potassium or magnesium in the blood may also||
2258|156|P|increase your risk of QT prolongation. This risk may increase if||
2258|157|P|you use certain drugs (such as diuretics/"water pills") or if you||
2258|158|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2258|159|P|Talk to your doctor about using this product safely.||
2258|160|P|   This medication may mask signs of infection. It can make you||
2258|161|P|more likely to get infections or may make current infections||
2258|162|P|worse. Stay away from anyone who has an infection that may easily||
2258|163|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2258|164|P|doctor if you have been exposed to an infection or for more||
2258|165|P|details.||
2258|166|P|   If you have switched from a corticosteroid taken by mouth||
2258|167|P|(such as prednisone tablets) to this inhaler within the past 12||
2258|168|P|months, or if you have been using this product in||
2258|169|P|higher-than-usual doses for a long time, it may be more difficult||
2258|170|P|for your body to respond to physical stress. Before having||
2258|171|P|surgery or emergency treatment, or if you get a serious||
2258|172|P|illness/injury, tell your doctor or dentist that you are using||
2258|173|P|this medication or have used a corticosteroid taken by mouth||
2258|174|P|within the past 12 months. Tell your doctor right away if you||
2258|175|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
2258|176|P|card or medical ID bracelet that says you use (or have used)||
2258|177|P|corticosteroid medications.||
2258|178|P|   Before having surgery, tell your doctor or dentist about all||
2258|179|P|the products you use (including prescription drugs,||
2258|180|P|nonprescription drugs, and herbal products).||
2258|181|P|   This medication may temporarily slow down a child's growth if||
2258|182|P|used for a long time. However, poorly controlled asthma can also||
2258|183|P|slow down growth. See the doctor regularly so your child's height||
2258|184|P|can be checked.||
2258|185|P|   Older adults may be more sensitive to the side effects of this||
2258|186|P|drug, especially QT prolongation (see above).||
2258|187|P|   During pregnancy, this medication should be used only when||
2258|188|P|clearly needed. Discuss the risks and benefits with your doctor.||
2258|189|P|   Budesonide passes into breast milk. It is unknown if||
2258|190|P|glycopyrrolate or formoterol passes into breast milk. Consult||
2258|191|P|your doctor before breastfeeding.||
2258|192|B|||
2258|193|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2258|194|I|medications work or increase your risk for serious side effects.||
2258|195|I|This document does not contain all possible drug interactions.||
2258|196|I|Keep a list of all the products you use (including||
2258|197|I|prescription/nonprescription drugs and herbal products) and share||
2258|198|I|it with your doctor and pharmacist. Do not start, stop, or change||
2258|199|I|the dosage of any medicines without your doctor's approval.||
2258|200|I|   A product that may interact with this drug is: desmopressin.||
2258|201|I|   Do not use other LABA drugs (such as arformoterol, salmeterol)||
2258|202|I|while using this medication.||
2258|203|B|||
2258|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2258|205|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2258|206|O|poison control center right away. US residents can call||
2258|207|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2258|208|O|Symptoms of overdose may include: shaking (tremor), chest pain,||
2258|209|O|fast/irregular heartbeat, severe dizziness, seizures.||
2258|210|B|||
2258|211|N|NOTES:  Do not share this medication with others.||
2258|212|N|   Lab and/or medical tests (such as lung function, blood||
2258|213|N|pressure, pulse/heart rate, eye exams) should be done while you||
2258|214|N|are using this medication. Keep all medical and lab appointments.||
2258|215|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
2258|216|N|mold that can worsen breathing problems. Because the flu virus||
2258|217|N|can also worsen breathing problems, ask your doctor or pharmacist||
2258|218|N|if you should have a flu shot every year.||
2258|219|N|   This medication may cause bone loss (osteoporosis) in adults||
2258|220|N|when used for a long time. Lifestyle changes that may help reduce||
2258|221|N|the risk of bone problems include doing weight-bearing exercise,||
2258|222|N|stopping smoking, limiting alcohol, and getting enough calcium||
2258|223|N|and vitamin D. Talk to your doctor for more details.||
2258|224|B|||
2258|225|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2258|226|D|If it is near the time of the next dose, skip the missed dose.||
2258|227|D|Use your next dose at the regular time. Do not double the dose to||
2258|228|D|catch up.||
2258|229|B|||
2258|230|R|STORAGE:  Store at room temperature away from light and heat. Do||
2258|231|R|not store near an open flame. Do not open the sealed pouch until||
2258|232|R|you are ready to use a new inhaler. Once the pouch is opened,||
2258|233|R|this medication expires after 3 months (for the 120-inhalation||
2258|234|R|product) or 3 weeks (for the 28-inhalation product). Keep all||
2258|235|R|medications away from children and pets.||
2258|236|R|   Do not flush medications down the toilet or pour them into a||
2258|237|R|drain unless instructed to do so. Properly discard this product||
2258|238|R|when it is expired or no longer needed. Consult your pharmacist||
2258|239|R|or local waste disposal company.||
2258|240|B|||
2258|241|M|MEDICAL ALERT:  Your condition can cause complications in a||
2258|242|M|medical emergency. For information about enrolling in MedicAlert,||
2258|243|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2258|244|B|||
2258|245|A|Information last revised September 2025.||
2258|246|A|Copyright(c) 2025 First Databank, Inc.||
2258|247|B|||
2259|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2259|002|Z|does NOT have all possible information about this product. This||
2259|003|Z|information does not assure that this product is safe, effective,||
2259|004|Z|or appropriate for you. This information is not individual||
2259|005|Z|medical advice and does not substitute for the advice of your||
2259|006|Z|health care professional. Always ask your health care||
2259|007|Z|professional for complete information about this product and your||
2259|008|Z|specific health needs.||
2259|009|B|||
2259|010|T|MONOMETHYL FUMARATE DELAYED-RELEASE - ORAL||
2259|011|F|(MON-oh-METH-il FUE-ma-rate)||
2259|012|B|||
2259|013|C|COMMON BRAND NAME(S): Bafiertam||
2259|014|B|||
2259|015|U|USES:  Monomethyl fumarate is used to treat multiple sclerosis||
2259|016|U|(MS). It is not a cure for MS, but it may help decrease the||
2259|017|U|number of relapses and prevent or delay disability.||
2259|018|B|||
2259|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2259|020|H|from your pharmacist before you start taking monomethyl fumarate||
2259|021|H|and each time you get a refill. If you have any questions, ask||
2259|022|H|your doctor or pharmacist.||
2259|023|H|   Take this medication by mouth with or without food as directed||
2259|024|H|by your doctor, usually twice daily. To reduce your risk of side||
2259|025|H|effects, your doctor may direct you to start this medication at a||
2259|026|H|low dose for the first 7 days, and gradually increase your dose.||
2259|027|H|Follow your doctor's instructions carefully.||
2259|028|H|   Swallow the capsules whole. Do not open, crush, chew, or mix||
2259|029|H|the contents with food. Doing so can release all of the drug at||
2259|030|H|once, increasing the risk of side effects.||
2259|031|H|   If flushing occurs, ask your doctor about taking a plain||
2259|032|H|(non-enteric coated) aspirin 30 minutes before taking this||
2259|033|H|medication to help prevent flushing.||
2259|034|H|   Take this medication regularly to get the most benefit from||
2259|035|H|it. To help you remember, take it at the same times each day.||
2259|036|H|   Tell your doctor if your condition does not get better or if||
2259|037|H|it gets worse.||
2259|038|B|||
2259|039|S|SIDE EFFECTS:  Flushing/warmth, redness, itching, or burning||
2259|040|S|feeling of the skin may occur. Stomach/abdominal pain, diarrhea,||
2259|041|S|nausea, and vomiting may also occur. Taking this medication||
2259|042|S|without food may lessen stomach/abdominal side effects. These||
2259|043|S|effects usually decrease or go away as your body adjusts to the||
2259|044|S|medication. If any of these effects last or get worse, tell your||
2259|045|S|doctor or pharmacist promptly.||
2259|046|S|   Remember that this medication has been prescribed because your||
2259|047|S|doctor has judged that the benefit to you is greater than the||
2259|048|S|risk of side effects. Many people using this medication do not||
2259|049|S|have serious side effects.||
2259|050|S|   This medication may lower your ability to fight infections.||
2259|051|S|This may make you more likely to get a serious (rarely fatal)||
2259|052|S|infection or make any infection you have worse. Tell your doctor||
2259|053|S|right away if you have any signs of infection (such as sore||
2259|054|S|throat that doesn't go away, fever, chills, blisters).||
2259|055|S|   Tell your doctor right away if you have any serious side||
2259|056|S|effects, including: symptoms of liver damage (such as||
2259|057|S|nausea/vomiting that doesn't stop, loss of appetite,||
2259|058|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2259|059|S|black/bloody stools, vomit that contains blood or looks like||
2259|060|S|coffee grounds, coughing up blood.||
2259|061|S|   This medication may increase your risk of getting a rare but||
2259|062|S|very serious (possibly fatal) brain infection (progressive||
2259|063|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2259|064|S|if you have any of these side effects: clumsiness, loss of||
2259|065|S|coordination/balance, weakness, sudden change in your thinking||
2259|066|S|(such as confusion, difficulty concentrating/memory loss),||
2259|067|S|difficulty talking/walking, seizure, vision changes.||
2259|068|S|   A very serious allergic reaction to this drug is rare.||
2259|069|S|However, get medical help right away if you notice any symptoms||
2259|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2259|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2259|072|S|breathing.||
2259|073|S|   This is not a complete list of possible side effects. If you||
2259|074|S|notice other effects not listed above, contact your doctor or||
2259|075|S|pharmacist.||
2259|076|S|   In the US -||
2259|077|S|   Call your doctor for medical advice about side effects. You||
2259|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2259|079|S|www.fda.gov/medwatch.||
2259|080|S|   In Canada - Call your doctor for medical advice about side||
2259|081|S|effects. You may report side effects to Health Canada at||
2259|082|S|1-866-234-2345.||
2259|083|B|||
2259|084|P|PRECAUTIONS:  Before taking monomethyl fumarate, tell your doctor||
2259|085|P|or pharmacist if you are allergic to it; or to dimethyl fumarate;||
2259|086|P|or to diroximel fumarate; or if you have any other allergies.||
2259|087|P|This product may contain inactive ingredients which can cause||
2259|088|P|allergic reactions or other problems. Talk to your pharmacist for||
2259|089|P|more details.||
2259|090|P|   Before using this medication, tell your doctor or pharmacist||
2259|091|P|your medical history, especially of: recent/past/current||
2259|092|P|infections, liver disease.||
2259|093|P|   Monomethyl fumarate can make you more likely to get infections||
2259|094|P|or may make current infections worse. Stay away from anyone who||
2259|095|P|has an infection that may easily spread (such as chickenpox,||
2259|096|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2259|097|P|exposed to an infection or for more details.||
2259|098|P|   Tell your health care professional that you are using||
2259|099|P|monomethyl fumarate before having any immunizations/vaccinations.||
2259|100|P|Avoid contact with people who have recently received live||
2259|101|P|vaccines (such as flu vaccine inhaled through the nose).||
2259|102|P|   Before having surgery, tell your doctor or dentist about all||
2259|103|P|the products you use (including prescription drugs,||
2259|104|P|nonprescription drugs, and herbal products).||
2259|105|P|   During pregnancy, this medication should be used only when||
2259|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
2259|107|P|   It is unknown if this medication passes into breast milk.||
2259|108|P|Consult your doctor before breastfeeding.||
2259|109|B|||
2259|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2259|111|I|medications work or increase your risk for serious side effects.||
2259|112|I|This document does not contain all possible drug interactions.||
2259|113|I|Keep a list of all the products you use (including||
2259|114|I|prescription/nonprescription drugs and herbal products) and share||
2259|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
2259|116|I|the dosage of any medicines without your doctor's approval.||
2259|117|I|   Some products that may interact with this drug are: other||
2259|118|I|drugs that weaken the immune system/increase the risk of||
2259|119|I|infection (such as natalizumab, rituximab).||
2259|120|I|   Monomethyl fumarate is very similar to dimethyl fumarate and||
2259|121|I|diroximel fumarate. Do not use medications containing dimethyl||
2259|122|I|fumarate or diroximel fumarate while using monomethyl fumarate.||
2259|123|B|||
2259|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2259|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2259|126|O|poison control center right away. US residents can call||
2259|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2259|128|B|||
2259|129|N|NOTES:  Do not share this medication with others.||
2259|130|N|   Lab and/or medical tests (such as complete blood counts, liver||
2259|131|N|function) should be done before you start taking this medication||
2259|132|N|and while you are taking it. Keep all medical and lab||
2259|133|N|appointments.||
2259|134|B|||
2259|135|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2259|136|D|remember. If it is near the time of the next dose, skip the||
2259|137|D|missed dose. Take your next dose at the regular time. Do not||
2259|138|D|double the dose to catch up.||
2259|139|B|||
2259|140|R|STORAGE:  Store the unopened bottle in the refrigerator away from||
2259|141|R|light and moisture. After opening, store the medication in the||
2259|142|R|original bottle at room temperature. Do not store in the||
2259|143|R|bathroom. Once the bottle is opened, this medication expires||
2259|144|R|after 3 months. Keep all medications away from children and pets.||
2259|145|R|   Do not flush medications down the toilet or pour them into a||
2259|146|R|drain unless instructed to do so. Properly discard this product||
2259|147|R|when it is expired or no longer needed. Consult your pharmacist||
2259|148|R|or local waste disposal company.||
2259|149|B|||
2259|150|M|MEDICAL ALERT:  Your condition can cause complications in a||
2259|151|M|medical emergency. For information about enrolling in MedicAlert,||
2259|152|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2259|153|B|||
2259|154|A|Information last revised May 2025.||
2259|155|A|Copyright(c) 2025 First Databank, Inc.||
2259|156|B|||
2260|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2260|002|Z|does NOT have all possible information about this product. This||
2260|003|Z|information does not assure that this product is safe, effective,||
2260|004|Z|or appropriate for you. This information is not individual||
2260|005|Z|medical advice and does not substitute for the advice of your||
2260|006|Z|health care professional. Always ask your health care||
2260|007|Z|professional for complete information about this product and your||
2260|008|Z|specific health needs.||
2260|009|B|||
2260|010|T|TAFASITAMAB - INJECTION||
2260|011|F|(TA-fa-SIT-a-mab)||
2260|012|B|||
2260|013|C|COMMON BRAND NAME(S): Monjuvi||
2260|014|B|||
2260|015|U|USES:  This medication is used to treat certain types of cancer||
2260|016|U|(diffuse large B-cell lymphoma, follicular lymphoma). Tafasitamab||
2260|017|U|belongs to a class of drugs known as monoclonal antibodies. It||
2260|018|U|works by slowing or stopping the growth of cancer cells.||
2260|019|B|||
2260|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2260|021|H|from your pharmacist before you start using tafasitamab and each||
2260|022|H|time you get a refill. If you have any questions, ask your doctor||
2260|023|H|or pharmacist.||
2260|024|H|   This medication is given by slow injection into a vein as||
2260|025|H|directed by your doctor. The injection is given by a health care||
2260|026|H|professional, usually over about 90 to 120 minutes.||
2260|027|H|   The dosage and treatment schedule are based on your medical||
2260|028|H|condition, weight, and response to treatment.||
2260|029|H|   Infusion reactions may happen during the infusion of this||
2260|030|H|drug. Your doctor may prescribe other medications (such as||
2260|031|H|acetaminophen, diphenhydramine, corticosteroids) before each||
2260|032|H|treatment to help prevent these side effects. Tell your doctor||
2260|033|H|right away if you have any symptoms of infusion reactions such as||
2260|034|H|fever, chills, flushing, headache, or shortness of breath. Your||
2260|035|H|doctor may give you other medications to help with these side||
2260|036|H|effects or may slow down or stop your treatment for some time.||
2260|037|H|   Use this medication regularly to get the most benefit from it.||
2260|038|H|To help you remember, mark your calendar with a reminder.||
2260|039|B|||
2260|040|S|SIDE EFFECTS:  See also How to Use section.||
2260|041|S|   Tiredness, diarrhea, nausea, vomiting, loss of appetite, back||
2260|042|S|pain, or muscle spasms may occur. If any of these effects last or||
2260|043|S|get worse, tell your doctor or pharmacist promptly.||
2260|044|S|   People using this medication may have serious side effects.||
2260|045|S|However, you have been prescribed this drug because your doctor||
2260|046|S|has judged that the benefit to you is greater than the risk of||
2260|047|S|side effects. Careful monitoring by your doctor may decrease your||
2260|048|S|risk.||
2260|049|S|   Tell your doctor right away if you have any serious side||
2260|050|S|effects, including: easy bruising/bleeding, swelling arms/legs.||
2260|051|S|   This medication may lower your ability to fight infections.||
2260|052|S|This may make you more likely to get a serious (rarely fatal)||
2260|053|S|infection or make any infection you have worse. Tell your doctor||
2260|054|S|right away if you have any signs of infection (such as sore||
2260|055|S|throat that doesn't go away, fever, chills, painful/frequent||
2260|056|S|urination).||
2260|057|S|   This medication may increase your risk of getting a rare but||
2260|058|S|very serious (possibly fatal) brain infection (progressive||
2260|059|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2260|060|S|if you have any of these side effects: clumsiness, loss of||
2260|061|S|coordination/balance, weakness, sudden change in your thinking||
2260|062|S|(such as confusion, difficulty concentrating, memory loss),||
2260|063|S|difficulty talking/walking, seizure, vision changes.||
2260|064|S|   A very serious allergic reaction to this drug is rare.||
2260|065|S|However, get medical help right away if you notice any symptoms||
2260|066|S|of a serious allergic reaction, including: rash, itching/swelling||
2260|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2260|068|S|breathing.||
2260|069|S|   This is not a complete list of possible side effects. If you||
2260|070|S|notice other effects not listed above, contact your doctor or||
2260|071|S|pharmacist.||
2260|072|S|   In the US -||
2260|073|S|   Call your doctor for medical advice about side effects. You||
2260|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2260|075|S|www.fda.gov/medwatch.||
2260|076|S|   In Canada - Call your doctor for medical advice about side||
2260|077|S|effects. You may report side effects to Health Canada at||
2260|078|S|1-866-234-2345.||
2260|079|B|||
2260|080|P|PRECAUTIONS:  Before using tafasitamab, tell your doctor or||
2260|081|P|pharmacist if you are allergic to it; or if you have any other||
2260|082|P|allergies. This product may contain inactive ingredients, which||
2260|083|P|can cause allergic reactions or other problems. Talk to your||
2260|084|P|pharmacist for more details.||
2260|085|P|   Before using this medication, tell your doctor or pharmacist||
2260|086|P|your medical history, especially of: current/recent infection.||
2260|087|P|   Tafasitamab can make you more likely to get infections or may||
2260|088|P|make current infections worse. Stay away from anyone who has an||
2260|089|P|infection that may easily spread (such as chickenpox, COVID-19,||
2260|090|P|measles, flu). Talk to your doctor if you have been exposed to an||
2260|091|P|infection or for more details.||
2260|092|P|   Tell your health care professional that you are using||
2260|093|P|tafasitamab before having any immunizations/vaccinations. Avoid||
2260|094|P|contact with people who have recently received live vaccines||
2260|095|P|(such as flu vaccine inhaled through the nose).||
2260|096|P|   To lower the chance of getting cut, bruised, or injured, use||
2260|097|P|caution with sharp objects like razors and nail cutters, and||
2260|098|P|avoid activities such as contact sports.||
2260|099|P|   Before having surgery, tell your doctor or dentist about all||
2260|100|P|the products you use (including prescription drugs,||
2260|101|P|nonprescription drugs, and herbal products).||
2260|102|P|   Tell your doctor if you are pregnant or plan to become||
2260|103|P|pregnant. You should not become pregnant while using tafasitamab.||
2260|104|P|Tafasitamab may harm an unborn baby. Ask about reliable forms of||
2260|105|P|birth control while using this medication and for at least 3||
2260|106|P|months after the last dose. If you become pregnant, talk to your||
2260|107|P|doctor right away about the risks and benefits of this||
2260|108|P|medication.||
2260|109|P|   It is unknown if this drug passes into breast milk. Because of||
2260|110|P|the possible risk to the infant, breastfeeding is not recommended||
2260|111|P|while using this drug and for at least 3 months after the last||
2260|112|P|dose. Consult your doctor before breastfeeding.||
2260|113|B|||
2260|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2260|115|I|medications work or increase your risk for serious side effects.||
2260|116|I|This document does not contain all possible drug interactions.||
2260|117|I|Keep a list of all the products you use (including||
2260|118|I|prescription/nonprescription drugs and herbal products) and share||
2260|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
2260|120|I|the dosage of any medicines without your doctor's approval.||
2260|121|I|   Some products that may interact with this drug are: other||
2260|122|I|drugs that weaken the immune system/increase the risk of||
2260|123|I|infection (such as natalizumab, rituximab).||
2260|124|B|||
2260|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2260|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2260|127|O|poison control center right away. US residents can call||
2260|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2260|129|B|||
2260|130|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
2260|131|N|should be done before you start using this medication and while||
2260|132|N|you are using it. Keep all medical and lab appointments.||
2260|133|B|||
2260|134|D|MISSED DOSE:  It is important to get each dose of this medication||
2260|135|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2260|136|D|right away for a new dosing schedule.||
2260|137|B|||
2260|138|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2260|139|R|hospital and will not be stored at home.||
2260|140|B|||
2260|141|M|MEDICAL ALERT:  Your condition can cause complications in a||
2260|142|M|medical emergency. For information about enrolling in MedicAlert,||
2260|143|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2260|144|B|||
2260|145|A|Information last revised June 2025.||
2260|146|A|Copyright(c) 2025 First Databank, Inc.||
2260|147|B|||
2263|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2263|002|Z|does NOT have all possible information about this product. This||
2263|003|Z|information does not assure that this product is safe, effective,||
2263|004|Z|or appropriate for you. This information is not individual||
2263|005|Z|medical advice and does not substitute for the advice of your||
2263|006|Z|health care professional. Always ask your health care||
2263|007|Z|professional for complete information about this product and your||
2263|008|Z|specific health needs.||
2263|009|B|||
2263|010|T|BELANTAMAB MAFODOTIN - INJECTION||
2263|011|F|(bal-AN-ta-mab MA-foe-DOE-tin)||
2263|012|B|||
2263|013|C|COMMON BRAND NAME(S): Blenrep||
2263|014|B|||
2263|015|W|WARNING:  This medication may cause serious eye problems. Changes||
2263|016|W|to the surface of your eye can lead to dry/itchy eyes, ulcer, or||
2263|017|W|vision changes (such as blurred/decreased vision). Your doctor||
2263|018|W|will have you do eye exams before starting this medication and||
2263|019|W|while you are using it. To help prevent dry eyes, use||
2263|020|W|preservative-free lubricant eye drops at least 4 times a day as||
2263|021|W|directed. Avoid wearing contact lenses during treatment with this||
2263|022|W|medication unless your doctor tells you otherwise. Tell your||
2263|023|W|doctor right away if you have any vision changes or eye problems||
2263|024|W|during treatment with this medication.||
2263|025|W|   To receive belantamab mafodotin in the United States, you must||
2263|026|W|understand, agree to, and carefully follow the requirements of||
2263|027|W|the REMS Program for this medication. If you live in Canada or||
2263|028|W|any other country, consult your doctor and pharmacist for your||
2263|029|W|country's regulations.||
2263|030|B|||
2263|031|U|USES:  This medication is used to treat a certain type of cancer||
2263|032|U|(multiple myeloma). Belantamab mafodotin belongs to a class of||
2263|033|U|drugs known as monoclonal antibodies. It works by slowing or||
2263|034|U|stopping the growth of cancer cells.||
2263|035|B|||
2263|036|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2263|037|H|Patient Information Leaflet provided by your pharmacist before||
2263|038|H|you start using belantamab mafodotin and each time you get a||
2263|039|H|treatment. If you have any questions, ask your doctor or||
2263|040|H|pharmacist.||
2263|041|H|   This medication is given by a health care professional. It is||
2263|042|H|injected slowly into a vein over 30 minutes. The dosage is based||
2263|043|H|on your medical condition, weight, and response to treatment.||
2263|044|H|   Infusion reactions may happen during the infusion of this||
2263|045|H|drug. Your doctor may prescribe other medications before each||
2263|046|H|treatment to help prevent these side effects. Tell your doctor||
2263|047|H|right away if you have any symptoms of infusion reactions such as||
2263|048|H|flushing, shortness of breath, dizziness, weakness, or fast||
2263|049|H|heartbeat. Your doctor may give you other medications to help||
2263|050|H|with these side effects or may slow down or stop your treatment||
2263|051|H|for some time.||
2263|052|H|   Use this medication regularly to get the most benefit from it.||
2263|053|H|To help you remember, mark your calendar with a reminder.||
2263|054|B|||
2263|055|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2263|056|S|   Nausea, loss of appetite, constipation or diarrhea, blurred||
2263|057|S|vision, back/joint pain, or tiredness may occur. If any of these||
2263|058|S|effects last or get worse, tell your doctor or pharmacist||
2263|059|S|promptly.||
2263|060|S|   People using this medication may have serious side effects.||
2263|061|S|However, you have been prescribed this drug because your doctor||
2263|062|S|has judged that the benefit to you is greater than the risk of||
2263|063|S|side effects. Careful monitoring by your doctor may decrease your||
2263|064|S|risk.||
2263|065|S|   Tell your doctor right away if you have any serious side||
2263|066|S|effects, including: easy bruising/bleeding, signs of lung||
2263|067|S|problems (such as chest pain, cough).||
2263|068|S|   This medication may lower your ability to fight infections.||
2263|069|S|This may make you more likely to get a serious (rarely fatal)||
2263|070|S|infection or make any infection you have worse. Tell your doctor||
2263|071|S|right away if you have any signs of infection (such as sore||
2263|072|S|throat that doesn't go away, fever, chills).||
2263|073|S|   A very serious allergic reaction to this drug is rare.||
2263|074|S|However, get medical help right away if you notice any symptoms||
2263|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2263|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2263|077|S|breathing.||
2263|078|S|   This is not a complete list of possible side effects. If you||
2263|079|S|notice other effects not listed above, contact your doctor or||
2263|080|S|pharmacist.||
2263|081|S|   In the US -||
2263|082|S|   Call your doctor for medical advice about side effects. You||
2263|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2263|084|S|www.fda.gov/medwatch.||
2263|085|S|   In Canada - Call your doctor for medical advice about side||
2263|086|S|effects. You may report side effects to Health Canada at||
2263|087|S|1-866-234-2345.||
2263|088|B|||
2263|089|P|PRECAUTIONS:  Before using belantamab mafodotin, tell your doctor||
2263|090|P|or pharmacist if you are allergic to it; or if you have any other||
2263|091|P|allergies. This product may contain inactive ingredients, which||
2263|092|P|can cause allergic reactions or other problems. Talk to your||
2263|093|P|pharmacist for more details.||
2263|094|P|   Before using this medication, tell your doctor or pharmacist||
2263|095|P|your medical history, especially of: current/recent infection,||
2263|096|P|eye problems, kidney problems, liver problems.||
2263|097|P|   Belantamab mafodotin can make you more likely to get||
2263|098|P|infections or may make current infections worse. Stay away from||
2263|099|P|anyone who has an infection that may easily spread (such as||
2263|100|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
2263|101|P|have been exposed to an infection or for more details.||
2263|102|P|   Tell your health care professional that you are using||
2263|103|P|belantamab mafodotin before having any||
2263|104|P|immunizations/vaccinations. Avoid contact with people who have||
2263|105|P|recently received live vaccines (such as flu vaccine inhaled||
2263|106|P|through the nose).||
2263|107|P|   To lower the chance of getting cut, bruised, or injured, use||
2263|108|P|caution with sharp objects like razors and nail cutters, and||
2263|109|P|avoid activities such as contact sports.||
2263|110|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
2263|111|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
2263|112|P|use machinery, or do anything that needs alertness or clear||
2263|113|P|vision until you can do it safely. Limit alcoholic beverages.||
2263|114|P|Talk to your doctor if you are using marijuana (cannabis).||
2263|115|P|   Before having surgery, tell your doctor or dentist about all||
2263|116|P|the products you use (including prescription drugs,||
2263|117|P|nonprescription drugs, and herbal products).||
2263|118|P|   Tell your doctor if you are pregnant or plan to become||
2263|119|P|pregnant. You should not become pregnant while using belantamab||
2263|120|P|mafodotin. Belantamab mafodotin may harm an unborn baby. Your||
2263|121|P|doctor should order a pregnancy test before you start this||
2263|122|P|medication. Women using this medication should ask about reliable||
2263|123|P|forms of birth control during treatment and for 4 months after||
2263|124|P|the last dose. Men using this medication should ask about||
2263|125|P|reliable forms of birth control during treatment and for 6 months||
2263|126|P|after the last dose. If you or your partner becomes pregnant,||
2263|127|P|talk to your doctor right away about the risks and benefits of||
2263|128|P|this medication.||
2263|129|P|   It is unknown if this medication passes into breast milk.||
2263|130|P|Because of the possible risk to the infant, breastfeeding is not||
2263|131|P|recommended while using this medication and for at least 3 months||
2263|132|P|after the last dose. Consult your doctor before breastfeeding.||
2263|133|B|||
2263|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2263|135|I|medications work or increase your risk for serious side effects.||
2263|136|I|This document does not contain all possible drug interactions.||
2263|137|I|Keep a list of all the products you use (including||
2263|138|I|prescription/nonprescription drugs and herbal products) and share||
2263|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
2263|140|I|the dosage of any medicines without your doctor's approval.||
2263|141|B|||
2263|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2263|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2263|144|O|poison control center right away. US residents can call||
2263|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2263|146|B|||
2263|147|N|NOTES:  Lab and/or medical tests (such as eye exams, complete||
2263|148|N|blood count) should be done before you start using this||
2263|149|N|medication and while you are using it. Keep all medical and lab||
2263|150|N|appointments. Consult your doctor for more details.||
2263|151|B|||
2263|152|D|MISSED DOSE:  It is important to get each dose of this medication||
2263|153|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2263|154|D|right away for a new dosing schedule.||
2263|155|B|||
2263|156|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2263|157|R|hospital and will not be stored at home.||
2263|158|B|||
2263|159|M|MEDICAL ALERT:  Your condition can cause complications in a||
2263|160|M|medical emergency. For information about enrolling in MedicAlert,||
2263|161|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2263|162|B|||
2263|163|A|Information last revised October 2025.||
2263|164|A|Copyright(c) 2025 First Databank, Inc.||
2263|165|B|||
2264|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2264|002|Z|does NOT have all possible information about this product. This||
2264|003|Z|information does not assure that this product is safe, effective,||
2264|004|Z|or appropriate for you. This information is not individual||
2264|005|Z|medical advice and does not substitute for the advice of your||
2264|006|Z|health care professional. Always ask your health care||
2264|007|Z|professional for complete information about this product and your||
2264|008|Z|specific health needs.||
2264|009|B|||
2264|010|T|DECITABINE/CEDAZURIDINE - ORAL||
2264|011|F|(dee-SYE-ta-been/SED-az-URE-i-deen)||
2264|012|B|||
2264|013|C|COMMON BRAND NAME(S): Inqovi||
2264|014|B|||
2264|015|U|USES:  This medication contains 2 ingredients: decitabine and||
2264|016|U|cedazuridine. It is used to treat a group of blood/bone marrow||
2264|017|U|disorders (myelodysplastic syndromes-MDS) in which the bone||
2264|018|U|marrow does not produce enough healthy blood cells. People with||
2264|019|U|MDS may have problems such as infections, anemia, and easy||
2264|020|U|bleeding/bruising. Decitabine is thought to work by helping your||
2264|021|U|bone marrow make normal blood cells. Decitabine also slows or||
2264|022|U|stops the growth of abnormal blood cells that grow too fast and||
2264|023|U|do not work properly. Cedazuridine helps decitabine work better||
2264|024|U|by helping to prevent its breakdown in your body.||
2264|025|B|||
2264|026|H|HOW TO USE:  Take this medication by mouth on an empty stomach as||
2264|027|H|directed by your doctor, usually once daily on days 1 through 5||
2264|028|H|of each 28-day treatment cycle. Swallow the tablets whole. Do not||
2264|029|H|cut, crush, or chew the tablets. Do not eat for at least 2 hours||
2264|030|H|before and 2 hours after taking this medication.||
2264|031|H|   If you vomit after taking a dose, do not take another dose.||
2264|032|H|Take your next dose at the regular time.||
2264|033|H|   The dosage is based on your medical condition and response to||
2264|034|H|treatment.||
2264|035|H|   Take this medication regularly to get the most benefit from||
2264|036|H|it. To help you remember, use it at the same time on days 1||
2264|037|H|through 5 of your treatment cycle.||
2264|038|H|   Do not increase your dose or use this drug more often or for||
2264|039|H|longer than prescribed. Your condition will not improve any||
2264|040|H|faster, and your risk of serious side effects will increase.||
2264|041|H|   Since this drug can be absorbed through the skin and lungs and||
2264|042|H|may harm an unborn baby, women who are pregnant or who may become||
2264|043|H|pregnant should not handle this medication or breathe the dust||
2264|044|H|from the tablets.||
2264|045|B|||
2264|046|S|SIDE EFFECTS:  Tiredness, nausea, vomiting, constipation or||
2264|047|S|diarrhea, loss of appetite, dizziness, headache, trouble||
2264|048|S|sleeping, or muscle/joint pain may occur. If any of these effects||
2264|049|S|last or get worse, tell your doctor or pharmacist promptly.||
2264|050|S|   Pain or sores in the mouth and throat may occur. Brush your||
2264|051|S|teeth carefully/gently, avoid using mouthwash that contains||
2264|052|S|alcohol, and rinse your mouth often with cool water mixed with||
2264|053|S|baking soda or salt. It may also be best to eat soft, moist||
2264|054|S|foods.||
2264|055|S|   People using this medication may have serious side effects.||
2264|056|S|However, you have been prescribed this drug because your doctor||
2264|057|S|has judged that the benefit to you is greater than the risk of||
2264|058|S|side effects. Careful monitoring by your doctor may decrease your||
2264|059|S|risk.||
2264|060|S|   Tell your doctor right away if you have any serious side||
2264|061|S|effects, including: easy bleeding/bruising, unusual tiredness,||
2264|062|S|pale skin, arm/leg swelling.||
2264|063|S|   This medication may lower your ability to fight infections.||
2264|064|S|This may make you more likely to get a serious (rarely fatal)||
2264|065|S|infection or make any infection you have worse. Tell your doctor||
2264|066|S|right away if you have any signs of infection (such as sore||
2264|067|S|throat that doesn't go away, fever, chills).||
2264|068|S|   This medication can commonly cause a rash that is usually not||
2264|069|S|serious. However, you may not be able to tell it apart from a||
2264|070|S|rare rash that could be a sign of a severe reaction. Tell your||
2264|071|S|doctor right away if you develop any rash.||
2264|072|S|   A very serious allergic reaction to this drug is rare.||
2264|073|S|However, get medical help right away if you notice any symptoms||
2264|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2264|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2264|076|S|breathing.||
2264|077|S|   This is not a complete list of possible side effects. If you||
2264|078|S|notice other effects not listed above, contact your doctor or||
2264|079|S|pharmacist.||
2264|080|S|   In the US -||
2264|081|S|   Call your doctor for medical advice about side effects. You||
2264|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2264|083|S|www.fda.gov/medwatch.||
2264|084|S|   In Canada - Call your doctor for medical advice about side||
2264|085|S|effects. You may report side effects to Health Canada at||
2264|086|S|1-866-234-2345.||
2264|087|B|||
2264|088|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2264|089|P|pharmacist if you are allergic to decitabine or cedazuridine; or||
2264|090|P|if you have any other allergies. This product may contain||
2264|091|P|inactive ingredients, which can cause allergic reactions or other||
2264|092|P|problems. Talk to your pharmacist for more details.||
2264|093|P|   Before using this medication, tell your doctor or pharmacist||
2264|094|P|your medical history, especially of: current/recent infection,||
2264|095|P|kidney problems, liver problems.||
2264|096|P|   This medication can make you more likely to get infections or||
2264|097|P|may make current infections worse. Stay away from anyone who has||
2264|098|P|an infection that may easily spread (such as chickenpox,||
2264|099|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2264|100|P|exposed to an infection or for more details.||
2264|101|P|   Tell your health care professional that you are using this||
2264|102|P|medication before having any immunizations/vaccinations. Avoid||
2264|103|P|contact with people who have recently received live vaccines||
2264|104|P|(such as flu vaccine inhaled through the nose).||
2264|105|P|   To lower the chance of getting cut, bruised, or injured, use||
2264|106|P|caution with sharp objects like razors and nail cutters, and||
2264|107|P|avoid activities such as contact sports.||
2264|108|P|   Before having surgery, tell your doctor or dentist about all||
2264|109|P|the products you use (including prescription drugs,||
2264|110|P|nonprescription drugs, and herbal products).||
2264|111|P|   Since this drug can be absorbed through the skin and lungs and||
2264|112|P|may harm an unborn baby, women who are pregnant or who may become||
2264|113|P|pregnant should not handle this medication or breathe the dust||
2264|114|P|from the tablets.||
2264|115|P|   Tell your doctor if you are pregnant or plan to become||
2264|116|P|pregnant. You should not become pregnant while using||
2264|117|P|decitabine/cedazuridine. Decitabine/cedazuridine may harm an||
2264|118|P|unborn baby. Your doctor should order a pregnancy test before you||
2264|119|P|start this medication. Women using this medication should ask||
2264|120|P|about reliable forms of birth control during treatment and for at||
2264|121|P|least 6 months after the last dose. Men using this medication||
2264|122|P|should ask about reliable forms of birth control during treatment||
2264|123|P|and for at least 3 months after the last dose. If you or your||
2264|124|P|partner becomes pregnant, talk to your doctor right away about||
2264|125|P|the risks and benefits of this medication.||
2264|126|P|   It is unknown if this drug passes into breast milk. Because of||
2264|127|P|the possible risk to the infant, breastfeeding is not recommended||
2264|128|P|while using this drug and for at least 2 weeks after the last||
2264|129|P|dose. Consult your doctor before breastfeeding.||
2264|130|B|||
2264|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2264|132|I|medications work or increase your risk for serious side effects.||
2264|133|I|This document does not contain all possible drug interactions.||
2264|134|I|Keep a list of all the products you use (including||
2264|135|I|prescription/nonprescription drugs and herbal products) and share||
2264|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
2264|137|I|the dosage of any medicines without your doctor's approval.||
2264|138|B|||
2264|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2264|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2264|141|O|poison control center right away. US residents can call||
2264|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2264|143|B|||
2264|144|N|NOTES:  Lab tests (such as complete blood counts, liver function,||
2264|145|N|kidney function) should be done while you are using this||
2264|146|N|medication. Keep all medical and lab appointments.||
2264|147|B|||
2264|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2264|149|D|remember. If it is more than 12 hours after the missed dose, skip||
2264|150|D|the missed dose. Take your next dose at the regular time. Do not||
2264|151|D|double the dose to catch up. Extend the dosing period by one day||
2264|152|D|for every missed dose to finish 5 doses for each cycle. Ask your||
2264|153|D|doctor or pharmacist if you have any questions.||
2264|154|B|||
2264|155|R|STORAGE:  Store in the original packaging at room temperature||
2264|156|R|away from light and moisture. Do not store in the bathroom. Keep||
2264|157|R|all medications away from children and pets.||
2264|158|R|   Do not flush medications down the toilet or pour them into a||
2264|159|R|drain unless instructed to do so. Properly discard this product||
2264|160|R|when it is expired or no longer needed. Consult your pharmacist||
2264|161|R|or local waste disposal company.||
2264|162|B|||
2264|163|M|MEDICAL ALERT:  Your condition can cause complications in a||
2264|164|M|medical emergency. For information about enrolling in MedicAlert,||
2264|165|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2264|166|B|||
2264|167|A|Information last revised April 2025.||
2264|168|A|Copyright(c) 2025 First Databank, Inc.||
2264|169|B|||
2265|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2265|002|Z|does NOT have all possible information about this product. This||
2265|003|Z|information does not assure that this product is safe, effective,||
2265|004|Z|or appropriate for you. This information is not individual||
2265|005|Z|medical advice and does not substitute for the advice of your||
2265|006|Z|health care professional. Always ask your health care||
2265|007|Z|professional for complete information about this product and your||
2265|008|Z|specific health needs.||
2265|009|B|||
2265|010|T|OXYMETAZOLINE - OPHTHALMIC||
2265|011|F|(OX-i-me-TAZ-oh-leen)||
2265|012|B|||
2265|013|C|COMMON BRAND NAME(S): Upneeq||
2265|014|B|||
2265|015|U|USES:  This medication is used to treat a certain eyelid||
2265|016|U|condition (acquired blepharoptosis) that causes drooping upper||
2265|017|U|eyelid(s). It belongs to a class of drugs known as alpha||
2265|018|U|agonists. Oxymetazoline works by making a certain eyelid muscle||
2265|019|U|get shorter and tighter (contract).||
2265|020|B|||
2265|021|H|HOW TO USE:  Read the Instructions for Use leaflet if available||
2265|022|H|from your pharmacist before you start using oxymetazoline and||
2265|023|H|each time you get a refill. If you have any questions, ask your||
2265|024|H|doctor or pharmacist.||
2265|025|H|   Use this medication in the affected eye(s) as directed by your||
2265|026|H|doctor, usually once daily.||
2265|027|H|   To apply eye drops, wash hands first. To avoid contamination,||
2265|028|H|do not touch the dropper tip or let it touch your eye or any||
2265|029|H|other surface.||
2265|030|H|   If you are wearing contact lenses, remove them before using||
2265|031|H|eye drops. Wait at least 15 minutes before replacing your contact||
2265|032|H|lenses. Tilt your head back, look upward, and pull down the lower||
2265|033|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2265|034|H|and place one drop into the pouch. Look downward, gently close||
2265|035|H|your eyes, and place one finger at the corner of your eye (near||
2265|036|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2265|037|H|opening your eyes. This will prevent the medication from draining||
2265|038|H|out. Try not to blink or rub your eye. If a drop misses your eye,||
2265|039|H|try again. If directed to use this medication in both eyes,||
2265|040|H|repeat these steps for your other eye. After you have applied the||
2265|041|H|daily dose of oxymetazoline, throw away the single-use container.||
2265|042|H|Do not save any unused medication left in the single-use||
2265|043|H|container.||
2265|044|H|   Before using, check this product for cloudiness or||
2265|045|H|discoloration. If either is present, do not use the liquid.||
2265|046|H|   If you are using another kind of eye medication (such as drops||
2265|047|H|or ointments), wait at least 15 minutes before applying other||
2265|048|H|medications. Use eye drops before eye ointments to allow the||
2265|049|H|drops to enter the eye.||
2265|050|H|   Wait several minutes for your vision to clear before driving||
2265|051|H|or operating machinery.||
2265|052|H|   Use this medication regularly to get the most benefit from it.||
2265|053|H|To help you remember, use it at the same time each day.||
2265|054|H|   Tell your doctor if your condition does not get better or if||
2265|055|H|it gets worse.||
2265|056|B|||
2265|057|S|SIDE EFFECTS:  Stinging, irritation, tearing, dry eye, or blurred||
2265|058|S|vision may occur. If any of these effects last or get worse, tell||
2265|059|S|your doctor or pharmacist promptly.||
2265|060|S|   Remember that this medication has been prescribed because your||
2265|061|S|doctor has judged that the benefit to you is greater than the||
2265|062|S|risk of side effects. Many people using this medication do not||
2265|063|S|have serious side effects.||
2265|064|S|   Tell your doctor right away if you have any serious side||
2265|065|S|effects, including: redness/itching/swelling in or around the||
2265|066|S|eyes, vision changes, drooping eyelids.||
2265|067|S|   Get medical help right away if you have any very serious side||
2265|068|S|effects, including: eye pain.||
2265|069|S|   A very serious allergic reaction to this drug is rare.||
2265|070|S|However, get medical help right away if you notice any symptoms||
2265|071|S|of a serious allergic reaction, including: rash, itching/swelling||
2265|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2265|073|S|breathing.||
2265|074|S|   This is not a complete list of possible side effects. If you||
2265|075|S|notice other effects not listed above, contact your doctor or||
2265|076|S|pharmacist.||
2265|077|S|   In the US -||
2265|078|S|   Call your doctor for medical advice about side effects. You||
2265|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2265|080|S|www.fda.gov/medwatch.||
2265|081|S|   In Canada - Call your doctor for medical advice about side||
2265|082|S|effects. You may report side effects to Health Canada at||
2265|083|S|1-866-234-2345.||
2265|084|B|||
2265|085|P|PRECAUTIONS:  Before using oxymetazoline, tell your doctor or||
2265|086|P|pharmacist if you are allergic to it; or if you have any other||
2265|087|P|allergies. This product may contain inactive ingredients, which||
2265|088|P|can cause allergic reactions or other problems. Talk to your||
2265|089|P|pharmacist for more details.||
2265|090|P|   Before using this medication, tell your doctor or pharmacist||
2265|091|P|your medical history, especially of: high or low blood pressure,||
2265|092|P|heart problems, stroke, other eye problems (such as glaucoma, eye||
2265|093|P|infection/mass), a certain immune system disorder (Sjogren's||
2265|094|P|syndrome), certain muscle/nerve problems (such as Horner||
2265|095|P|syndrome, myasthenia gravis).||
2265|096|P|   After you apply this drug, your vision may become temporarily||
2265|097|P|blurred. Do not drive, use machinery, or do anything that needs||
2265|098|P|clear vision until you can do it safely.||
2265|099|P|   During pregnancy, this medication should be used only when||
2265|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
2265|101|P|   It is unknown if this drug passes into breast milk. Consult||
2265|102|P|your doctor before breastfeeding.||
2265|103|B|||
2265|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2265|105|I|medications work or increase your risk for serious side effects.||
2265|106|I|This document does not contain all possible drug interactions.||
2265|107|I|Keep a list of all the products you use (including||
2265|108|I|prescription/nonprescription drugs and herbal products) and share||
2265|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
2265|110|I|the dosage of any medicines without your doctor's approval.||
2265|111|B|||
2265|112|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2265|113|O|has overdosed and has serious symptoms such as passing out or||
2265|114|O|trouble breathing, call 911. Otherwise, call a poison control||
2265|115|O|center right away. US residents can call 1-800-222-1222. Canada||
2265|116|O|residents can call 1-844-764-7669.||
2265|117|B|||
2265|118|N|NOTES:  Do not share this medication with others.||
2265|119|N|   Keep all medical and lab appointments.||
2265|120|B|||
2265|121|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2265|122|D|If it is near the time of the next dose, skip the missed dose.||
2265|123|D|Use your next dose at the regular time. Do not double the dose to||
2265|124|D|catch up.||
2265|125|B|||
2265|126|R|STORAGE:  Store at room temperature away from light and heat.||
2265|127|R|Keep the single-use containers in the foil pouch until ready to||
2265|128|R|use. Keep all medications away from children and pets.||
2265|129|R|   Do not flush medications down the toilet or pour them into a||
2265|130|R|drain unless instructed to do so. Properly discard this product||
2265|131|R|when it is expired or no longer needed. Consult your pharmacist||
2265|132|R|or local waste disposal company.||
2265|133|B|||
2265|134|A|Information last revised February 2025.||
2265|135|A|Copyright(c) 2025 First Databank, Inc.||
2265|136|B|||
2266|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2266|002|Z|does NOT have all possible information about this product. This||
2266|003|Z|information does not assure that this product is safe, effective,||
2266|004|Z|or appropriate for you. This information is not individual||
2266|005|Z|medical advice and does not substitute for the advice of your||
2266|006|Z|health care professional. Always ask your health care||
2266|007|Z|professional for complete information about this product and your||
2266|008|Z|specific health needs.||
2266|009|B|||
2266|010|T|OCTREOTIDE DELAYED-RELEASE - ORAL||
2266|011|F|(ok-TREE-oh-tide)||
2266|012|B|||
2266|013|C|COMMON BRAND NAME(S): Mycapssa||
2266|014|B|||
2266|015|U|USES:  Octreotide is used to treat a certain condition||
2266|016|U|(acromegaly) that occurs when the body makes too much of a||
2266|017|U|certain natural substance called growth hormone. Treating||
2266|018|U|acromegaly helps reduce the risk of serious problems such as||
2266|019|U|diabetes and heart disease. Octreotide works by decreasing how||
2266|020|U|much growth hormone your body makes.||
2266|021|U|   This drug is not a cure for acromegaly. This medication is||
2266|022|U|usually used with other treatment (such as surgery, radiation,||
2266|023|U|other drugs).||
2266|024|B|||
2266|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
2266|026|H|Instructions for Use if available from your pharmacist before you||
2266|027|H|start using octreotide and each time you get a refill. If you||
2266|028|H|have any questions, ask your doctor or pharmacist.||
2266|029|H|   Take this medication by mouth on an empty stomach at least 1||
2266|030|H|hour before a meal or at least 2 hours after a meal as directed||
2266|031|H|by your doctor, usually twice daily. Swallow the capsule(s) whole||
2266|032|H|with a glass of water. Do not crush or chew the capsules. Doing||
2266|033|H|so can release all of the drug at once, increasing the risk of||
2266|034|H|side effects.||
2266|035|H|   The dosage is based on your medical condition, response to||
2266|036|H|treatment, lab tests, and other medications you may be taking. Be||
2266|037|H|sure to tell your doctor and pharmacist about all the products||
2266|038|H|you use (including prescription drugs, nonprescription drugs, and||
2266|039|H|herbal products). To reduce your risk of side effects, your||
2266|040|H|doctor may direct you to start this medication at a low dose and||
2266|041|H|gradually increase your dose. Your doctor may also stop your||
2266|042|H|medication from time to time to monitor your medical condition.||
2266|043|H|Follow your doctor's instructions carefully.||
2266|044|H|   Use this medication regularly to get the most benefit from it.||
2266|045|H|To help you remember, take it at the same times each day.||
2266|046|H|   Tell your doctor if your condition does not get better or if||
2266|047|H|it gets worse.||
2266|048|B|||
2266|049|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach upset, gas,||
2266|050|S|bloating, dizziness, muscle/joint pain, or headache may occur. If||
2266|051|S|any of these effects last or get worse, tell your doctor or||
2266|052|S|pharmacist promptly.||
2266|053|S|   Remember that this medication has been prescribed because your||
2266|054|S|doctor has judged that the benefit to you is greater than the||
2266|055|S|risk of side effects. Many people using this medication do not||
2266|056|S|have serious side effects.||
2266|057|S|   Tell your doctor right away if you have any serious side||
2266|058|S|effects, including: signs of gallbladder/liver problems (such as||
2266|059|S|fever, nausea/vomiting that doesn't stop, loss of appetite,||
2266|060|S|stomach/abdominal pain, yellowing eyes/skin, dark urine,||
2266|061|S|unexplained pain in the back/right shoulder), signs of||
2266|062|S|underactive thyroid (such as unexplained weight gain, cold||
2266|063|S|intolerance, severe constipation, unusual tiredness,||
2266|064|S|growth/lump/swelling on the front of the neck),||
2266|065|S|slow/fast/irregular heartbeat, swelling of the arms/legs, weight||
2266|066|S|loss, change in stool color.||
2266|067|S|   This medication may cause changes in blood sugar, especially||
2266|068|S|if you have diabetes. Symptoms of high blood sugar include||
2266|069|S|increased thirst and urination. Symptoms of low blood sugar||
2266|070|S|include sudden sweating, shaking, fast heartbeat, hunger, blurred||
2266|071|S|vision, dizziness, or tingling hands/feet. Tell your doctor right||
2266|072|S|away if you experience symptoms of high or low blood sugar while||
2266|073|S|using this medication. If you already have diabetes, check your||
2266|074|S|blood sugar regularly as directed and share the results with your||
2266|075|S|doctor. Your doctor may need to adjust your diabetes medication,||
2266|076|S|exercise program, or diet.||
2266|077|S|   A very serious allergic reaction to this drug is rare.||
2266|078|S|However, get medical help right away if you notice any symptoms||
2266|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2266|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2266|081|S|breathing.||
2266|082|S|   This is not a complete list of possible side effects. If you||
2266|083|S|notice other effects not listed above, contact your doctor or||
2266|084|S|pharmacist.||
2266|085|S|   In the US -||
2266|086|S|   Call your doctor for medical advice about side effects. You||
2266|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2266|088|S|www.fda.gov/medwatch.||
2266|089|S|   In Canada - Call your doctor for medical advice about side||
2266|090|S|effects. You may report side effects to Health Canada at||
2266|091|S|1-866-234-2345.||
2266|092|B|||
2266|093|P|PRECAUTIONS:  Before using octreotide, tell your doctor or||
2266|094|P|pharmacist if you are allergic to it; or if you have any other||
2266|095|P|allergies. This product may contain inactive ingredients, which||
2266|096|P|can cause allergic reactions or other problems. Talk to your||
2266|097|P|pharmacist for more details.||
2266|098|P|   Before using this medication, tell your doctor or pharmacist||
2266|099|P|your medical history, especially of: kidney problems, liver||
2266|100|P|disease, diabetes, thyroid problems, gallbladder problems (such||
2266|101|P|as gallstones), heart problems (such as heart failure), nutrition||
2266|102|P|problems (such as decreased fat absorption, vitamin B12||
2266|103|P|deficiency).||
2266|104|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2266|105|P|can make you more dizzy. Do not drive, use machinery, or do||
2266|106|P|anything that needs alertness until you can do it safely. Limit||
2266|107|P|alcoholic beverages. Talk to your doctor if you are using||
2266|108|P|marijuana (cannabis).||
2266|109|P|   Before having surgery, tell your doctor or dentist about all||
2266|110|P|the products you use (including prescription drugs,||
2266|111|P|nonprescription drugs, and herbal products).||
2266|112|P|   Treatment with this medication may improve fertility in women||
2266|113|P|and may lead to unintended pregnancy. Ask your doctor for more||
2266|114|P|details.||
2266|115|P|   During pregnancy, this medication should be used only when||
2266|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
2266|117|P|   It is unknown if this medication passes into breast milk.||
2266|118|P|Consult your doctor before breastfeeding.||
2266|119|B|||
2266|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2266|121|I|medications work or increase your risk for serious side effects.||
2266|122|I|This document does not contain all possible drug interactions.||
2266|123|I|Keep a list of all the products you use (including||
2266|124|I|prescription/nonprescription drugs and herbal products) and share||
2266|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
2266|126|I|the dosage of any medicines without your doctor's approval.||
2266|127|B|||
2266|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2266|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2266|130|O|poison control center right away. US residents can call||
2266|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2266|132|B|||
2266|133|N|NOTES:  Do not share this medication with others.||
2266|134|N|   Lab and/or medical tests (such as blood sugar, thyroid||
2266|135|N|function, hormone levels, vitamin B12 levels) should be done||
2266|136|N|before you start using this medication and while you are using||
2266|137|N|it. Keep all medical and lab appointments.||
2266|138|B|||
2266|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2266|140|D|remember. If it is near the time of the next dose, skip the||
2266|141|D|missed dose. Take your next dose at the regular time. Do not||
2266|142|D|double the dose to catch up.||
2266|143|B|||
2266|144|R|STORAGE:  Store the unopened medication (wallet) in the||
2266|145|R|refrigerator. Do not freeze. Store the opened wallet at room||
2266|146|R|temperature. Do not store in the bathroom. Once the wallet is||
2266|147|R|opened, this medication expires after 1 month. Keep all||
2266|148|R|medications away from children and pets.||
2266|149|R|   Do not flush medications down the toilet or pour them into a||
2266|150|R|drain unless instructed to do so. Properly discard this product||
2266|151|R|when it is expired or no longer needed. Consult your pharmacist||
2266|152|R|or local waste disposal company.||
2266|153|B|||
2266|154|A|Information last revised October 2025.||
2266|155|A|Copyright(c) 2025 First Databank, Inc.||
2266|156|B|||
2267|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2267|002|Z|does NOT have all possible information about this product. This||
2267|003|Z|information does not assure that this product is safe, effective,||
2267|004|Z|or appropriate for you. This information is not individual||
2267|005|Z|medical advice and does not substitute for the advice of your||
2267|006|Z|health care professional. Always ask your health care||
2267|007|Z|professional for complete information about this product and your||
2267|008|Z|specific health needs.||
2267|009|B|||
2267|010|T|SATRALIZUMAB - SUBCUTANEOUS INJECTION||
2267|011|F|(SAT-ra-LIZ-ue-mab)||
2267|012|B|||
2267|013|C|COMMON BRAND NAME(S): Enspryng||
2267|014|B|||
2267|015|U|USES:  This medication is used to treat a certain nervous system||
2267|016|U|disorder that affects the eye (optic) nerve and spinal cord||
2267|017|U|(neuromyelitis optica spectrum disorder-NMOSD). Satralizumab||
2267|018|U|belongs to a class of drugs known as monoclonal antibodies. It is||
2267|019|U|not a cure for NMOSD but is thought to help by blocking||
2267|020|U|interleukin-6, a substance made by the body. This effect may help||
2267|021|U|to reduce the risk of attacks and delay or slow disability.||
2267|022|B|||
2267|023|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2267|024|H|provided by your pharmacist before you start using satralizumab||
2267|025|H|and each time you get a refill. Ask your health care professional||
2267|026|H|how to prepare and use this medication. If you have any||
2267|027|H|questions, ask your doctor or pharmacist.||
2267|028|H|   Before starting treatment with this medication, your doctor||
2267|029|H|will test you for hepatitis B and tuberculosis (TB). If needed,||
2267|030|H|treatment for hepatitis B, tuberculosis, or other infections||
2267|031|H|should be done before receiving this medication.||
2267|032|H|   Inject this medication under the skin as directed by your||
2267|033|H|doctor. The injection is given in the abdomen or thigh. The first||
2267|034|H|3 doses are usually given 2 weeks apart. Later (maintenance)||
2267|035|H|doses are usually given every 4 weeks. The dosage and treatment||
2267|036|H|schedule are based on your medical condition and response to||
2267|037|H|treatment.||
2267|038|H|   Take the medication out of the refrigerator at least 30||
2267|039|H|minutes before you inject it to allow it to reach room||
2267|040|H|temperature. Do not warm up this medication any other way (for||
2267|041|H|example, do not heat it in the microwave or place it in hot||
2267|042|H|water). Do not shake the medication. Before using, check this||
2267|043|H|product for particles or discoloration. If either is present, do||
2267|044|H|not use the liquid. Before injecting each dose, clean the skin||
2267|045|H|you are going to inject into (the injection site) with rubbing||
2267|046|H|alcohol. Change the injection site each time to lessen injury||
2267|047|H|under the skin. Do not inject into skin that is tender, bruised,||
2267|048|H|red, hard, or damaged, or into moles or scars. To lessen||
2267|049|H|bruising, do not rub the injection site after a shot. Learn how||
2267|050|H|to store and discard medical supplies safely.||
2267|051|H|   Use this medication regularly to get the most benefit from it.||
2267|052|H|To help you remember, mark your calendar with a reminder.||
2267|053|H|   Tell your doctor if your condition does not get better or if||
2267|054|H|it gets worse.||
2267|055|B|||
2267|056|S|SIDE EFFECTS:  Irritation, itching, or a lump at the injection||
2267|057|S|site may occur. Joint/extremity pain, nausea, upset stomach,||
2267|058|S|tiredness, or headache may also occur. If any of these effects||
2267|059|S|last or get worse, tell your doctor or pharmacist promptly.||
2267|060|S|   Remember that this medication has been prescribed because your||
2267|061|S|doctor has judged that the benefit to you is greater than the||
2267|062|S|risk of side effects. Many people using this medication do not||
2267|063|S|have serious side effects.||
2267|064|S|   This medication may lower your ability to fight infections.||
2267|065|S|This may make you more likely to get a serious (rarely fatal)||
2267|066|S|infection or make any infection you have worse. Tell your doctor||
2267|067|S|right away if you have any signs of infection (such as sore||
2267|068|S|throat that doesn't go away, fever, chills).||
2267|069|S|   Satralizumab can commonly cause a rash that is usually not||
2267|070|S|serious. However, you may not be able to tell it apart from a||
2267|071|S|rare rash that could be a sign of a severe reaction. Tell your||
2267|072|S|doctor right away if you develop any rash.||
2267|073|S|   A very serious allergic reaction to this drug is rare.||
2267|074|S|However, get medical help right away if you notice any symptoms||
2267|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2267|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2267|077|S|breathing.||
2267|078|S|   This is not a complete list of possible side effects. If you||
2267|079|S|notice other effects not listed above, contact your doctor or||
2267|080|S|pharmacist.||
2267|081|S|   In the US -||
2267|082|S|   Call your doctor for medical advice about side effects. You||
2267|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2267|084|S|www.fda.gov/medwatch.||
2267|085|S|   In Canada - Call your doctor for medical advice about side||
2267|086|S|effects. You may report side effects to Health Canada at||
2267|087|S|1-866-234-2345.||
2267|088|B|||
2267|089|P|PRECAUTIONS:  Before using satralizumab, tell your doctor or||
2267|090|P|pharmacist if you are allergic to it; or if you have any other||
2267|091|P|allergies. This product may contain inactive ingredients, which||
2267|092|P|can cause allergic reactions or other problems. Talk to your||
2267|093|P|pharmacist for more details.||
2267|094|P|   Before using this medication, tell your doctor or pharmacist||
2267|095|P|your medical history, especially of: past/current/recent||
2267|096|P|infection (especially of hepatitis B, tuberculosis).||
2267|097|P|   Satralizumab can make you more likely to get infections or may||
2267|098|P|make current infections worse. Stay away from anyone who has an||
2267|099|P|infection that may easily spread (such as chickenpox, COVID-19,||
2267|100|P|measles, flu). Talk to your doctor if you have been exposed to an||
2267|101|P|infection or for more details.||
2267|102|P|   Tell your doctor your vaccine history and ask if you need to||
2267|103|P|get any vaccines before starting treatment with this medication.||
2267|104|P|Your doctor may direct you to have any required vaccines at least||
2267|105|P|2 to 4 weeks before starting this medication. Tell your health||
2267|106|P|care professional that you are using satralizumab before having||
2267|107|P|any immunizations/vaccinations. Avoid contact with people who||
2267|108|P|have recently received live vaccines (such as flu vaccine inhaled||
2267|109|P|through the nose).||
2267|110|P|   Before having surgery, tell your doctor or dentist about all||
2267|111|P|the products you use (including prescription drugs,||
2267|112|P|nonprescription drugs, and herbal products).||
2267|113|P|   During pregnancy, this medication should be used only when||
2267|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
2267|115|P|   It is unknown if this drug passes into breast milk. Consult||
2267|116|P|your doctor before breastfeeding.||
2267|117|B|||
2267|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2267|119|I|medications work or increase your risk for serious side effects.||
2267|120|I|This document does not contain all possible drug interactions.||
2267|121|I|Keep a list of all the products you use (including||
2267|122|I|prescription/nonprescription drugs and herbal products) and share||
2267|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
2267|124|I|the dosage of any medicines without your doctor's approval.||
2267|125|B|||
2267|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2267|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2267|128|O|poison control center right away. US residents can call||
2267|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2267|130|B|||
2267|131|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2267|132|N|liver function, tests for tuberculosis and hepatitis B) should be||
2267|133|N|done before you start using this medication and while you are||
2267|134|N|using it. Keep all medical and lab appointments.||
2267|135|B|||
2267|136|D|MISSED DOSE:  It is important to get each dose of this medication||
2267|137|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2267|138|D|right away for a new dosing schedule.||
2267|139|B|||
2267|140|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2267|141|R|medication in the original package to protect from light. The||
2267|142|R|unopened package may be taken out of the refrigerator and put||
2267|143|R|back in the refrigerator, if needed. The total time out of the||
2267|144|R|refrigerator should not be more than 8 days. Keep all medications||
2267|145|R|away from children and pets.||
2267|146|R|   Do not flush medications down the toilet or pour them into a||
2267|147|R|drain unless instructed to do so. Properly discard this product||
2267|148|R|when it is expired or no longer needed. Consult your pharmacist||
2267|149|R|or local waste disposal company.||
2267|150|B|||
2267|151|M|MEDICAL ALERT:  Your condition can cause complications in a||
2267|152|M|medical emergency. For information about enrolling in MedicAlert,||
2267|153|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2267|154|B|||
2267|155|A|Information last revised April 2025.||
2267|156|A|Copyright(c) 2025 First Databank, Inc.||
2267|157|B|||
2270|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2270|002|Z|does NOT have all possible information about this product. This||
2270|003|Z|information does not assure that this product is safe, effective,||
2270|004|Z|or appropriate for you. This information is not individual||
2270|005|Z|medical advice and does not substitute for the advice of your||
2270|006|Z|health care professional. Always ask your health care||
2270|007|Z|professional for complete information about this product and your||
2270|008|Z|specific health needs.||
2270|009|B|||
2270|010|T|RISDIPLAM SOLUTION - ORAL||
2270|011|F|(ris-DIP-lam)||
2270|012|B|||
2270|013|C|COMMON BRAND NAME(S): Evrysdi||
2270|014|B|||
2270|015|U|USES:  This medication is used to treat a certain muscle disorder||
2270|016|U|(spinal muscular atrophy - SMA).||
2270|017|B|||
2270|018|H|HOW TO USE:  Read the Patient Information Leaflet and||
2270|019|H|Instructions for Use if available from your pharmacist before you||
2270|020|H|start taking risdiplam and each time you get a refill. If you||
2270|021|H|have any questions, ask your doctor or pharmacist.||
2270|022|H|   Risdiplam should come as a liquid form prepared by the||
2270|023|H|pharmacy. If it is a powder form, do not use it and contact your||
2270|024|H|pharmacy right away.||
2270|025|H|   Take this medication by mouth with or without food as directed||
2270|026|H|by your doctor, usually once daily. The dosage is based on your||
2270|027|H|age and body weight. For infants who breastfeed, this medication||
2270|028|H|may be given before or after breastfeeding. Do not mix this||
2270|029|H|medication with formula, milk, or any other food or liquid. Drink||
2270|030|H|some water after taking this medication to make sure that the||
2270|031|H|medication is completely swallowed.||
2270|032|H|   For patients who cannot swallow and have a feeding tube, this||
2270|033|H|medication can be given through the tube. The tube should be||
2270|034|H|flushed with water after the medication is given.||
2270|035|H|   Carefully measure the dose using the provided measuring||
2270|036|H|syringe. Do not use a household spoon because you may not get the||
2270|037|H|correct dose. Once the dose is drawn into the syringe, it must be||
2270|038|H|taken right away. If it is not used within 5 minutes, the drug in||
2270|039|H|the syringe should be thrown away and a new dose prepared with||
2270|040|H|the syringe.||
2270|041|H|   Use this medication regularly to get the most benefit from it.||
2270|042|H|To help you remember, take it at the same time each day.||
2270|043|H|   If you vomit after taking a dose or did not take the full||
2270|044|H|dose, do not take another dose at that time. Take your next dose||
2270|045|H|at the regular time.||
2270|046|H|   Tell your doctor if your condition does not get better or if||
2270|047|H|it gets worse.||
2270|048|B|||
2270|049|S|SIDE EFFECTS:  Diarrhea, constipation, mouth sores, or joint pain||
2270|050|S|may occur. If any of these effects last or get worse, tell your||
2270|051|S|doctor or pharmacist promptly.||
2270|052|S|   Remember that this medication has been prescribed because your||
2270|053|S|doctor has judged that the benefit to you is greater than the||
2270|054|S|risk of side effects. Many people using this medication do not||
2270|055|S|have serious side effects.||
2270|056|S|   Tell your doctor right away if you have any serious side||
2270|057|S|effects, including: signs of infection (such as sore throat that||
2270|058|S|doesn't go away, fever, chills).||
2270|059|S|   Risdiplam can commonly cause a rash that is usually not||
2270|060|S|serious. However, you may not be able to tell it apart from a||
2270|061|S|rare rash that could be a sign of a severe reaction. Get medical||
2270|062|S|help right away if you develop any rash.||
2270|063|S|   A very serious allergic reaction to this drug is rare.||
2270|064|S|However, get medical help right away if you notice any symptoms||
2270|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2270|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2270|067|S|breathing.||
2270|068|S|   This is not a complete list of possible side effects. If you||
2270|069|S|notice other effects not listed above, contact your doctor or||
2270|070|S|pharmacist.||
2270|071|S|   In the US -||
2270|072|S|   Call your doctor for medical advice about side effects. You||
2270|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2270|074|S|www.fda.gov/medwatch.||
2270|075|S|   In Canada - Call your doctor for medical advice about side||
2270|076|S|effects. You may report side effects to Health Canada at||
2270|077|S|1-866-234-2345.||
2270|078|B|||
2270|079|P|PRECAUTIONS:  Before taking risdiplam, tell your doctor or||
2270|080|P|pharmacist if you are allergic to it; or if you have any other||
2270|081|P|allergies. This product may contain inactive ingredients, which||
2270|082|P|can cause allergic reactions or other problems. Talk to your||
2270|083|P|pharmacist for more details.||
2270|084|P|   Before using this medication, tell your doctor or pharmacist||
2270|085|P|your medical history, especially of: liver disease.||
2270|086|P|   Before having surgery, tell your doctor or dentist about all||
2270|087|P|the products you use (including prescription drugs,||
2270|088|P|nonprescription drugs, and herbal products).||
2270|089|P|   Tell your doctor if you are pregnant or plan to become||
2270|090|P|pregnant. You should not become pregnant while using risdiplam.||
2270|091|P|Risdiplam may harm an unborn baby. Your doctor should order a||
2270|092|P|pregnancy test before you start this medication. Ask about||
2270|093|P|reliable forms of birth control while using this medication and||
2270|094|P|for some time after the last dose. If you become pregnant, talk||
2270|095|P|to your doctor right away about the risks and benefits of this||
2270|096|P|medication.||
2270|097|P|   It is unknown if this medication passes into breast milk.||
2270|098|P|Consult your doctor before breastfeeding.||
2270|099|B|||
2270|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2270|101|I|medications work or increase your risk for serious side effects.||
2270|102|I|This document does not contain all possible drug interactions.||
2270|103|I|Keep a list of all the products you use (including||
2270|104|I|prescription/nonprescription drugs and herbal products) and share||
2270|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
2270|106|I|the dosage of any medicines without your doctor's approval.||
2270|107|I|   This medication can slow down the removal of other medications||
2270|108|I|from your body, which may affect how they work. An example of an||
2270|109|I|affected drug is dofetilide, among others.||
2270|110|B|||
2270|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2270|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2270|113|O|poison control center right away. US residents can call||
2270|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2270|115|B|||
2270|116|N|NOTES:  Do not share this medication with others.||
2270|117|B|||
2270|118|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2270|119|D|remember. If it is more than 6 hours after the missed dose, skip||
2270|120|D|the missed dose. Take your next dose at the regular time. Do not||
2270|121|D|double the dose to catch up.||
2270|122|B|||
2270|123|R|STORAGE:  Store the medication upright in the refrigerator. Do||
2270|124|R|not freeze. Keep the medication in the original bottle to protect||
2270|125|R|from light. This medication may be taken out of the refrigerator||
2270|126|R|and put back in the refrigerator if needed. The total time out of||
2270|127|R|the refrigerator should not be more than 5 days. The medication||
2270|128|R|expires 64 days after it was prepared by the pharmacy. Keep all||
2270|129|R|medications away from children and pets.||
2270|130|R|   Do not flush medications down the toilet or pour them into a||
2270|131|R|drain unless instructed to do so. Properly discard this product||
2270|132|R|when it is expired or no longer needed. Consult your pharmacist||
2270|133|R|or local waste disposal company.||
2270|134|B|||
2270|135|A|Information last revised September 2025.||
2270|136|A|Copyright(c) 2025 First Databank, Inc.||
2270|137|B|||
2272|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2272|002|Z|does NOT have all possible information about this product. This||
2272|003|Z|information does not assure that this product is safe, effective,||
2272|004|Z|or appropriate for you. This information is not individual||
2272|005|Z|medical advice and does not substitute for the advice of your||
2272|006|Z|health care professional. Always ask your health care||
2272|007|Z|professional for complete information about this product and your||
2272|008|Z|specific health needs.||
2272|009|B|||
2272|010|T|OFATUMUMAB - SUBCUTANEOUS INJECTION||
2272|011|F|(OH-fa-TOOM-ue-mab)||
2272|012|B|||
2272|013|C|COMMON BRAND NAME(S): Kesimpta||
2272|014|B|||
2272|015|U|USES:  This medication is used to treat multiple sclerosis (MS).||
2272|016|U|Ofatumumab belongs to a class of medications known as monoclonal||
2272|017|U|antibodies. This medication is not a cure for MS but it is||
2272|018|U|thought to help by preventing immune system cells (lymphocytes)||
2272|019|U|from attacking the nerves in your brain and spinal cord. It helps||
2272|020|U|decrease the number of episodes of disease worsening (relapses)||
2272|021|U|and may prevent or delay disability.||
2272|022|B|||
2272|023|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2272|024|H|provided by your pharmacist before you start using ofatumumab and||
2272|025|H|each time you get a refill. Ask your health care professional how||
2272|026|H|to prepare and use this medication. If you have any questions,||
2272|027|H|ask your doctor or pharmacist.||
2272|028|H|   Before starting treatment with this medication, your doctor||
2272|029|H|will test you for hepatitis B. If needed, treatment for hepatitis||
2272|030|H|B or other infections should be done before receiving this||
2272|031|H|medication.||
2272|032|H|   Inject this medication under the skin as directed by your||
2272|033|H|doctor. The first 3 doses are usually given 1 week apart. Later||
2272|034|H|(maintenance) doses are usually given every 4 weeks. The||
2272|035|H|injection is given in the abdomen, thigh, or upper arm. The||
2272|036|H|dosage and treatment schedule are based on your medical condition||
2272|037|H|and response to treatment.||
2272|038|H|   Take the medication out of the refrigerator 15 to 30 minutes||
2272|039|H|before you inject it to allow it to reach room temperature. Do||
2272|040|H|not warm up this medication any other way (for example, do not||
2272|041|H|heat it in the microwave or place it in hot water). Do not shake||
2272|042|H|the medication. Before using, check this product for particles or||
2272|043|H|discoloration. If either is present, do not use the liquid.||
2272|044|H|Before injecting each dose, clean the skin you are going to||
2272|045|H|inject into (the injection site) with rubbing alcohol. Change the||
2272|046|H|injection site each time to lessen injury under the skin. Do not||
2272|047|H|inject into moles, scars, stretch marks, or skin that is tender,||
2272|048|H|bruised, red, scaly, or hard. To lessen bruising, do not rub the||
2272|049|H|injection site after a shot. Learn how to store and discard||
2272|050|H|medical supplies safely.||
2272|051|H|   Use this medication regularly to get the most benefit from it.||
2272|052|H|To help you remember, mark your calendar with a reminder.||
2272|053|H|   Tell your doctor if your condition does not get better or if||
2272|054|H|it gets worse.||
2272|055|B|||
2272|056|S|SIDE EFFECTS:  Redness, swelling, itching, or pain at the||
2272|057|S|injection site may occur. Other common injection side effects||
2272|058|S|include fever, headache, muscle ache, chills, and tiredness.||
2272|059|S|These side effects usually lessen after the first few injections.||
2272|060|S|If any of these effects last or get worse, tell your doctor or||
2272|061|S|pharmacist promptly.||
2272|062|S|   Remember that this medication has been prescribed because your||
2272|063|S|doctor has judged that the benefit to you is greater than the||
2272|064|S|risk of side effects. Many people using this medication do not||
2272|065|S|have serious side effects.||
2272|066|S|   This medication may lower your ability to fight infections.||
2272|067|S|This may make you more likely to get a serious (rarely fatal)||
2272|068|S|infection or make any infection you have worse. Tell your doctor||
2272|069|S|right away if you have any signs of infection (such as sore||
2272|070|S|throat that doesn't go away, fever, chills).||
2272|071|S|   This drug may cause serious (possibly fatal) liver disease.||
2272|072|S|Also, if you have a current or past infection with hepatitis B,||
2272|073|S|this drug may cause the infection to return or worsen. This may||
2272|074|S|occur during treatment or after treatment is finished. Before||
2272|075|S|starting treatment with this medication, your doctor may order a||
2272|076|S|test to see if you have hepatitis B infection. Get medical help||
2272|077|S|right away if you have any symptoms of liver damage, such as:||
2272|078|S|nausea/vomiting that doesn't stop, loss of appetite,||
2272|079|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
2272|080|S|   This medication may increase your risk of getting a rare but||
2272|081|S|very serious (possibly fatal) brain infection (progressive||
2272|082|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2272|083|S|if you have any of these side effects: clumsiness, loss of||
2272|084|S|coordination/balance, weakness, sudden change in your thinking||
2272|085|S|(such as confusion, difficulty concentrating, memory loss),||
2272|086|S|difficulty talking/walking, seizure, vision changes.||
2272|087|S|   A very serious allergic reaction to this drug is rare.||
2272|088|S|However, get medical help right away if you notice any symptoms||
2272|089|S|of a serious allergic reaction, including: rash, itching/swelling||
2272|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2272|091|S|breathing.||
2272|092|S|   This is not a complete list of possible side effects. If you||
2272|093|S|notice other effects not listed above, contact your doctor or||
2272|094|S|pharmacist.||
2272|095|S|   In the US -||
2272|096|S|   Call your doctor for medical advice about side effects. You||
2272|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2272|098|S|www.fda.gov/medwatch.||
2272|099|S|   In Canada - Call your doctor for medical advice about side||
2272|100|S|effects. You may report side effects to Health Canada at||
2272|101|S|1-866-234-2345.||
2272|102|B|||
2272|103|P|PRECAUTIONS:  Before using ofatumumab, tell your doctor or||
2272|104|P|pharmacist if you are allergic to it; or if you have any other||
2272|105|P|allergies. This product may contain inactive ingredients, which||
2272|106|P|can cause allergic reactions or other problems. Talk to your||
2272|107|P|pharmacist for more details.||
2272|108|P|   Before using this medication, tell your doctor or pharmacist||
2272|109|P|your medical history, especially of: past/current/recent||
2272|110|P|infections, liver disease (especially hepatitis B), immune system||
2272|111|P|problems.||
2272|112|P|   Before having surgery, tell your doctor or dentist about all||
2272|113|P|the products you use (including prescription drugs,||
2272|114|P|nonprescription drugs, and herbal products).||
2272|115|P|   Ofatumumab can make you more likely to get infections or may||
2272|116|P|make current infections worse. Stay away from anyone who has an||
2272|117|P|infection that may easily spread (such as chickenpox, COVID-19,||
2272|118|P|measles, flu). Talk to your doctor if you have been exposed to an||
2272|119|P|infection or for more details.||
2272|120|P|   Tell your doctor your vaccine history and ask if you need to||
2272|121|P|get any vaccines before starting treatment with this medication.||
2272|122|P|Your doctor may direct you to have any required vaccines at least||
2272|123|P|2 to 4 weeks before starting this medication. Tell your health||
2272|124|P|care professional that you are using ofatumumab before having any||
2272|125|P|immunizations/vaccinations. Avoid contact with people who have||
2272|126|P|recently received live vaccines (such as flu vaccine inhaled||
2272|127|P|through the nose).||
2272|128|P|   Tell your doctor if you are pregnant or plan to become||
2272|129|P|pregnant. You should not become pregnant while using ofatumumab.||
2272|130|P|Ofatumumab may harm an unborn baby. Ask about reliable forms of||
2272|131|P|birth control while using this medication and for 6 months after||
2272|132|P|the last dose. If you become pregnant, talk to your doctor right||
2272|133|P|away about the risks and benefits of this medication.||
2272|134|P|   It is unknown if this drug passes into breast milk. Consult||
2272|135|P|your doctor before breastfeeding.||
2272|136|B|||
2272|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2272|138|I|medications work or increase your risk for serious side effects.||
2272|139|I|This document does not contain all possible drug interactions.||
2272|140|I|Keep a list of all the products you use (including||
2272|141|I|prescription/nonprescription drugs and herbal products) and share||
2272|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
2272|143|I|the dosage of any medicines without your doctor's approval.||
2272|144|I|   Some products that may interact with this drug are: other||
2272|145|I|drugs that weaken the immune system/increase the risk of||
2272|146|I|infection (such as natalizumab, rituximab).||
2272|147|B|||
2272|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2272|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2272|150|O|poison control center right away. US residents can call||
2272|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2272|152|B|||
2272|153|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2272|154|N|liver function, immunoglobulin levels, tests for hepatitis B)||
2272|155|N|should be done before you start using this medication and while||
2272|156|N|you are using it. Keep all medical and lab appointments.||
2272|157|B|||
2272|158|D|MISSED DOSE:  It is important to use each dose of this medication||
2272|159|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2272|160|D|right away for a new dosing schedule.||
2272|161|B|||
2272|162|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2272|163|R|medication in the original package to protect from light. This||
2272|164|R|medication may also be stored at room temperature if needed. If||
2272|165|R|the medication is stored at room temperature, discard after 7||
2272|166|R|days. Keep all medications away from children and pets.||
2272|167|R|   Do not flush medications down the toilet or pour them into a||
2272|168|R|drain unless instructed to do so. Properly discard this product||
2272|169|R|when it is expired or no longer needed. Consult your pharmacist||
2272|170|R|or local waste disposal company.||
2272|171|B|||
2272|172|M|MEDICAL ALERT:  Your condition can cause complications in a||
2272|173|M|medical emergency. For information about enrolling in MedicAlert,||
2272|174|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2272|175|B|||
2272|176|A|Information last revised April 2025.||
2272|177|A|Copyright(c) 2025 First Databank, Inc.||
2272|178|B|||
2273|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2273|002|Z|does NOT have all possible information about this product. This||
2273|003|Z|information does not assure that this product is safe, effective,||
2273|004|Z|or appropriate for you. This information is not individual||
2273|005|Z|medical advice and does not substitute for the advice of your||
2273|006|Z|health care professional. Always ask your health care||
2273|007|Z|professional for complete information about this product and your||
2273|008|Z|specific health needs.||
2273|009|B|||
2273|010|T|DOCETAXEL - INJECTION||
2273|011|F|(doh-seh-TAX-ell)||
2273|012|B|||
2273|013|C|COMMON BRAND NAME(S): Beizray, Taxotere||
2273|014|B|||
2273|015|W|WARNING:  Docetaxel has caused severe (rarely fatal) allergic||
2273|016|W|reactions and swelling (fluid retention/edema) even with the use||
2273|017|W|of preventive medications. This drug must not be used in patients||
2273|018|W|who have previously had an allergic reaction to it or to other||
2273|019|W|medications containing polysorbate 80.||
2273|020|W|   There is an increased risk of serious (possibly fatal)||
2273|021|W|reactions in patients using docetaxel who have liver problems,||
2273|022|W|patients receiving higher doses, and patients with non-small cell||
2273|023|W|lung cancer who have received certain other chemotherapy drugs||
2273|024|W|known as "platinums."||
2273|025|W|   Before using this medication, tell your doctor you medical||
2273|026|W|history, especially of liver problems, current/recent infections,||
2273|027|W|and low blood cell counts. Your doctor should monitor your labs||
2273|028|W|(such as liver function, blood counts) closely while you are||
2273|029|W|receiving this medication.||
2273|030|B|||
2273|031|U|USES:  This medication is used to treat cancer (such as breast,||
2273|032|U|lung, prostate, stomach, and head/neck cancer). Docetaxel is a||
2273|033|U|member of a family of drugs called taxanes. This drug works by||
2273|034|U|slowing cell growth.||
2273|035|B|||
2273|036|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2273|037|H|from your pharmacist before you start receiving docetaxel and||
2273|038|H|each time you get a treatment. If you have any questions, ask||
2273|039|H|your doctor, nurse, or pharmacist.||
2273|040|H|   This medication is given by injection into a vein by a health||
2273|041|H|care professional. It is given as directed by your doctor,||
2273|042|H|usually over 1 hour every 3 weeks. The dosage and frequency is||
2273|043|H|based on your medical condition, body size, and response to||
2273|044|H|treatment.||
2273|045|H|   Your doctor may prescribe pre-medications (such as||
2273|046|H|corticosteroids such as dexamethasone) to prevent side effects||
2273|047|H|like swelling (fluid retention/edema) and allergic reactions.||
2273|048|H|These are generally started 1 day before treatment and continued||
2273|049|H|for a total of 3 days. Carefully follow your doctor's orders to||
2273|050|H|prepare for your treatment. If you forget to take your||
2273|051|H|pre-medication, or do not take it on schedule, tell your doctor||
2273|052|H|or nurse before you receive your docetaxel treatment.||
2273|053|B|||
2273|054|S|SIDE EFFECTS:  See also Warning section.||
2273|055|S|   Pain or swelling at the injection site, nausea, vomiting,||
2273|056|S|diarrhea, excessive tearing, tiredness, dizziness, drowsiness,||
2273|057|S|feeling drunk, constipation, and loss of appetite may occur.||
2273|058|S|Nausea and vomiting can be severe. In some cases, your doctor may||
2273|059|S|prescribe medication to prevent or relieve nausea and vomiting.||
2273|060|S|Eating several small meals, not eating before treatment, or||
2273|061|S|limiting activity may help lessen some of these effects. If any||
2273|062|S|of these effects last or get worse, tell your doctor or||
2273|063|S|pharmacist promptly.||
2273|064|S|   Temporary hair loss and nail changes may occur. Normal hair||
2273|065|S|growth and nail appearance should return after treatment has||
2273|066|S|ended. However, hair loss may be permanent for some people.||
2273|067|S|   People using this medication may have serious side effects.||
2273|068|S|However, you have been prescribed this drug because your doctor||
2273|069|S|has judged that the benefit to you is greater than the risk of||
2273|070|S|side effects. Careful monitoring by your doctor may decrease your||
2273|071|S|risk.||
2273|072|S|   Tell your doctor right away if you have any serious side||
2273|073|S|effects, including: unusual tiredness/weakness, swelling||
2273|074|S|ankles/feet/hands, unexplained weight gain, swelling abdomen,||
2273|075|S|easy bruising/bleeding, mouth sores, numbness/tingling of||
2273|076|S|arms/legs, muscle/joint pain, eye pain, irregular heartbeat,||
2273|077|S|stomach/abdominal pain, severe diarrhea, diarrhea with blood or||
2273|078|S|mucus, severe headache.||
2273|079|S|   This medication can decrease your body's ability to fight an||
2273|080|S|infection. Tell your doctor right away if you develop any signs||
2273|081|S|of an infection (such as a sore throat that doesn't go away,||
2273|082|S|fever, chills).||
2273|083|S|   Although docetaxel is used to treat cancer, it may rarely||
2273|084|S|increase your risk of getting other cancers (such as acute||
2273|085|S|myeloid leukemia-AML, Non-Hodgkin's Lymphoma, kidney cancer).||
2273|086|S|This may occur months to years after treatment. Your doctor||
2273|087|S|should monitor you closely while you receive this medication and||
2273|088|S|after treatment with this medication.||
2273|089|S|   Docetaxel sometimes causes side effects due to the rapid||
2273|090|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
2273|091|S|risk, your doctor may add a medication and tell you to drink||
2273|092|S|plenty of fluids. Tell your doctor right away if you have||
2273|093|S|symptoms such as: low back/side pain (flank pain), signs of||
2273|094|S|kidney problems (such as painful urination, pink/bloody urine,||
2273|095|S|change in the amount of urine), muscle spasms/weakness.||
2273|096|S|   Get medical help right away if you have any very serious side||
2273|097|S|effects, including: chest pain, vision changes (such as blurred||
2273|098|S|vision, decreased vision, seeing flashes of light).||
2273|099|S|   A very serious allergic reaction to this drug is rare.||
2273|100|S|However, get medical help right away if you notice any symptoms||
2273|101|S|of a serious allergic reaction, including: rash, itching/swelling||
2273|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2273|103|S|breathing.||
2273|104|S|   This is not a complete list of possible side effects. If you||
2273|105|S|notice other effects not listed above, contact your doctor or||
2273|106|S|pharmacist.||
2273|107|S|   In the US -||
2273|108|S|   Call your doctor for medical advice about side effects. You||
2273|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2273|110|S|www.fda.gov/medwatch.||
2273|111|S|   In Canada - Call your doctor for medical advice about side||
2273|112|S|effects. You may report side effects to Health Canada at||
2273|113|S|1-866-234-2345.||
2273|114|B|||
2273|115|P|PRECAUTIONS:  See also Warning section.||
2273|116|P|   Before using docetaxel, tell your doctor or pharmacist if you||
2273|117|P|are allergic to it; or to similar drugs (taxane-type drugs such||
2273|118|P|as paclitaxel, cabazitaxel); or if you have any other allergies.||
2273|119|P|This product may contain inactive ingredients (such as||
2273|120|P|polysorbate 80), which can cause allergic reactions or other||
2273|121|P|problems. Talk to your pharmacist for more details.||
2273|122|P|   Before receiving docetaxel, tell your doctor or pharmacist||
2273|123|P|your medical history, especially of: liver problems, lung||
2273|124|P|problems (such as pulmonary effusions), heart problems (such as||
2273|125|P|heart failure), weak immune system (such as neutropenia), blood||
2273|126|P|problems (such as anemia, thrombocytopenia), blood pressure||
2273|127|P|problems.||
2273|128|P|   This medication may make you dizzy or drowsy. It also contains||
2273|129|P|alcohol, which can increase these symptoms and also make you feel||
2273|130|P|drunk. Caution is advised if you have liver disease or any other||
2273|131|P|condition that requires you to limit/avoid alcohol. Marijuana||
2273|132|P|(cannabis) can also make you more dizzy or drowsy. Do not drive,||
2273|133|P|use machinery, or do anything that needs alertness for 1 to 2||
2273|134|P|hours after you receive this medication and until you can do it||
2273|135|P|safely. Limit alcoholic beverages. Talk to your doctor if you are||
2273|136|P|using marijuana (cannabis).||
2273|137|P|   Docetaxel can make you more likely to get infections or may||
2273|138|P|make current infections worse. Stay away from anyone who has an||
2273|139|P|infection that may easily spread (such as chickenpox, COVID-19,||
2273|140|P|measles, flu). Talk to your doctor if you have been exposed to an||
2273|141|P|infection or for more details.||
2273|142|P|   Tell your health care professional that you are using||
2273|143|P|docetaxel before having any immunizations/vaccinations. Avoid||
2273|144|P|contact with people who have recently received live vaccines||
2273|145|P|(such as flu vaccine inhaled through the nose).||
2273|146|P|   To lower the chance of getting cut, bruised, or injured, use||
2273|147|P|caution with sharp objects like razors and nail cutters, and||
2273|148|P|avoid activities such as contact sports.||
2273|149|P|   Older adults may be more sensitive to the side effects of this||
2273|150|P|drug, especially anemia, dizziness, diarrhea, infection,||
2273|151|P|swelling, mouth sores, and weight loss.||
2273|152|P|   Tell your doctor if you are pregnant or plan to become||
2273|153|P|pregnant. You should not become pregnant while using docetaxel.||
2273|154|P|Docetaxel may harm an unborn baby. Your doctor should order a||
2273|155|P|pregnancy test before you start this medication. Men and women||
2273|156|P|using this medication should ask about reliable forms of birth||
2273|157|P|control during treatment and for some time after the last dose.||
2273|158|P|If you or your partner becomes pregnant, talk to your doctor||
2273|159|P|right away about the risks and benefits of this medication.||
2273|160|P|   It is unknown if this drug passes into breast milk. Because of||
2273|161|P|the possible risk to the infant, breastfeeding is not recommended||
2273|162|P|while using this drug and for 1 week after the last dose. Consult||
2273|163|P|your doctor before breastfeeding.||
2273|164|B|||
2273|165|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2273|166|I|medications work or increase your risk for serious side effects.||
2273|167|I|This document does not contain all possible drug interactions.||
2273|168|I|Keep a list of all the products you use (including||
2273|169|I|prescription/nonprescription drugs and herbal products) and share||
2273|170|I|it with your doctor and pharmacist. Do not start, stop, or change||
2273|171|I|the dosage of any medicines without your doctor's approval.||
2273|172|I|   Some products that may interact with this drug include:||
2273|173|I|medications that may have a bad reaction with alcohol (such as||
2273|174|I|disulfiram, metronidazole, tinidazole).||
2273|175|I|   Other medications can affect the removal of docetaxel from||
2273|176|I|your body, which may affect how docetaxel works. Examples include||
2273|177|I|azole antifungals (such as itraconazole), macrolide antibiotics||
2273|178|I|(such as erythromycin), rifamycins (such as rifabutin),||
2273|179|I|ritonavir, HIV drugs (such as atazanavir), St. John's wort, among||
2273|180|I|others.||
2273|181|I|   Tell your doctor or pharmacist if you are taking other||
2273|182|I|products that cause drowsiness such as other alcohol-containing||
2273|183|I|medications or alcoholic beverages, marijuana (cannabis), opioid||
2273|184|I|pain or cough relievers (such as codeine, hydrocodone), drugs for||
2273|185|I|sleep or anxiety (such as alprazolam, lorazepam, zolpidem),||
2273|186|I|muscle relaxants (such as carisoprodol, cyclobenzaprine), or||
2273|187|I|antihistamines (such as cetirizine, diphenhydramine).||
2273|188|I|   Check the labels on all your medicines (such as allergy or||
2273|189|I|cough-and-cold products) because they may contain ingredients||
2273|190|I|that cause drowsiness. Ask your pharmacist about using those||
2273|191|I|products safely.||
2273|192|B|||
2273|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2273|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2273|195|O|poison control center right away. US residents can call||
2273|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2273|197|B|||
2273|198|N|NOTES:  Lab and/or medical tests (such as blood cell counts,||
2273|199|N|liver function) should be done while you are using this||
2273|200|N|medication. Keep all medical and lab appointments. Consult your||
2273|201|N|doctor for more details.||
2273|202|B|||
2273|203|D|MISSED DOSE:  It is important to get each dose of this medication||
2273|204|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2273|205|D|right away for a new dosing schedule.||
2273|206|B|||
2273|207|R|STORAGE:  Not applicable. This medication is given in a clinic||
2273|208|R|and will not be stored at home.||
2273|209|B|||
2273|210|M|MEDICAL ALERT:  Your condition can cause complications in a||
2273|211|M|medical emergency. For information about enrolling in MedicAlert,||
2273|212|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2273|213|B|||
2273|214|A|Information last revised April 2025.||
2273|215|A|Copyright(c) 2025 First Databank, Inc.||
2273|216|B|||
2274|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2274|002|Z|does NOT have all possible information about this product. This||
2274|003|Z|information does not assure that this product is safe, effective,||
2274|004|Z|or appropriate for you. This information is not individual||
2274|005|Z|medical advice and does not substitute for the advice of your||
2274|006|Z|health care professional. Always ask your health care||
2274|007|Z|professional for complete information about this product and your||
2274|008|Z|specific health needs.||
2274|009|B|||
2274|010|T|RISPERIDONE - INJECTION||
2274|011|F|(riss-PAIR-ih-doan)||
2274|012|B|||
2274|013|C|COMMON BRAND NAME(S): Risperdal Consta||
2274|014|B|||
2274|015|W|WARNING:  There may be a slightly increased risk of serious,||
2274|016|W|possibly fatal side effects (such as stroke, heart failure,||
2274|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
2274|018|W|by older adults with dementia. This medication is not approved||
2274|019|W|for the treatment of dementia-related behavior problems. Discuss||
2274|020|W|the risks and benefits of this medication, as well as other||
2274|021|W|effective and possibly safer treatments for dementia-related||
2274|022|W|behavior problems, with the doctor.||
2274|023|B|||
2274|024|U|USES:  This medication is used to treat certain mental/mood||
2274|025|U|disorders (such as schizophrenia, bipolar disorder). Risperidone||
2274|026|U|belongs to a class of drugs known as atypical antipsychotics. It||
2274|027|U|works by helping to restore the balance of certain natural||
2274|028|U|substances in the brain.||
2274|029|B|||
2274|030|H|HOW TO USE:  This medication is given by injection into a muscle||
2274|031|H|(upper arm or buttocks) by a health care professional. It is||
2274|032|H|given as directed by your doctor, usually once every two weeks.||
2274|033|H|To reduce irritation from the injection, your doctor will||
2274|034|H|alternate between the left and right side with each dose.||
2274|035|H|   When you first start this medication, it may take at least 3||
2274|036|H|weeks before this medication starts working. During this time,||
2274|037|H|your doctor will instruct you to take another medication by||
2274|038|H|mouth. Follow your doctor's instructions carefully.||
2274|039|H|   The dosage is based on your medical condition, response to||
2274|040|H|treatment, and other medications you may be taking. Be sure to||
2274|041|H|tell your doctor and pharmacist about all the products you use||
2274|042|H|(including prescription drugs, nonprescription drugs, and herbal||
2274|043|H|products).||
2274|044|H|   You should receive this medication regularly to get the most||
2274|045|H|benefit from it. To help you remember, mark your calendar with a||
2274|046|H|reminder. Keep receiving this medication even if you feel well.||
2274|047|H|   Tell your doctor if your condition lasts or gets worse.||
2274|048|B|||
2274|049|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness,||
2274|050|S|constipation, tiredness, drooling, weight gain, or||
2274|051|S|redness/swelling/pain at the injection site may occur. If any of||
2274|052|S|these effects last or get worse, tell your doctor or pharmacist||
2274|053|S|promptly.||
2274|054|S|   Dizziness and lightheadedness can increase the risk of||
2274|055|S|falling. Get up slowly when rising from a sitting or lying||
2274|056|S|position.||
2274|057|S|   Remember that this medication has been prescribed because your||
2274|058|S|doctor has judged that the benefit to you is greater than the||
2274|059|S|risk of side effects. Many people using this medication do not||
2274|060|S|have serious side effects.||
2274|061|S|   Tell your doctor right away if you have any side effects,||
2274|062|S|including: difficulty swallowing, muscle spasms, shaking||
2274|063|S|(tremor), mental/mood changes (such as anxiety, restlessness),||
2274|064|S|interrupted breathing during sleep.||
2274|065|S|   This medication may rarely make your blood sugar rise, which||
2274|066|S|can cause or worsen diabetes. Tell your doctor right away if you||
2274|067|S|have symptoms of high blood sugar such as increased||
2274|068|S|thirst/urination. If you already have diabetes, check your blood||
2274|069|S|sugar regularly as directed and share the results with your||
2274|070|S|doctor. Your doctor may need to adjust your diabetes medication,||
2274|071|S|exercise program, or diet.||
2274|072|S|   This drug may also cause significant weight gain and a rise in||
2274|073|S|your blood cholesterol (or triglyceride) levels. These effects,||
2274|074|S|along with diabetes, may increase your risk for developing heart||
2274|075|S|disease. Discuss the risks and benefits of treatment with your||
2274|076|S|doctor. (See also Notes section.)||
2274|077|S|   Risperidone may rarely cause a condition known as tardive||
2274|078|S|dyskinesia. In some cases, this condition may be permanent. Tell||
2274|079|S|your doctor right away if you develop any unusual/uncontrolled||
2274|080|S|movements (especially of the face, lips, mouth, tongue, arms or||
2274|081|S|legs).||
2274|082|S|   This medication may increase a certain natural substance||
2274|083|S|(prolactin) made by your body. For females, this increase in||
2274|084|S|prolactin may result in unwanted breast milk, missed/stopped||
2274|085|S|periods, or difficulty becoming pregnant. For males, it may||
2274|086|S|result in decreased sexual ability, inability to produce sperm,||
2274|087|S|or enlarged breasts. If you develop any of these symptoms, tell||
2274|088|S|your doctor right away.||
2274|089|S|   Get medical help right away if you have any very serious side||
2274|090|S|effects, including: severe dizziness, fainting, seizures.||
2274|091|S|   This medication may rarely cause a very serious condition||
2274|092|S|called neuroleptic malignant syndrome (NMS). Get medical help||
2274|093|S|right away if you have any of the following symptoms: fever,||
2274|094|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
2274|095|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
2274|096|S|signs of kidney problems (such as change in the amount of urine).||
2274|097|S|   Rarely, males may have a painful or prolonged erection lasting||
2274|098|S|4 or more hours. If this occurs, stop using this drug and get||
2274|099|S|medical help right away, or permanent problems could occur.||
2274|100|S|   A very serious allergic reaction to this drug is rare.||
2274|101|S|However, get medical help right away if you notice any symptoms||
2274|102|S|of a serious allergic reaction, including: fever, swollen lymph||
2274|103|S|nodes, rash, itching/swelling (especially of the||
2274|104|S|face/tongue/throat), severe dizziness, trouble breathing.||
2274|105|S|   This is not a complete list of possible side effects. If you||
2274|106|S|notice other effects not listed above, contact your doctor or||
2274|107|S|pharmacist.||
2274|108|S|   In the US -||
2274|109|S|   Call your doctor for medical advice about side effects. You||
2274|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2274|111|S|www.fda.gov/medwatch.||
2274|112|S|   In Canada - Call your doctor for medical advice about side||
2274|113|S|effects. You may report side effects to Health Canada at||
2274|114|S|1-866-234-2345.||
2274|115|B|||
2274|116|P|PRECAUTIONS:  Before using risperidone, tell your doctor or||
2274|117|P|pharmacist if you are allergic to it; or to paliperidone; or if||
2274|118|P|you have any other allergies. This product may contain inactive||
2274|119|P|ingredients, which can cause allergic reactions or other||
2274|120|P|problems. Talk to your pharmacist for more details.||
2274|121|P|   Before using this medication, tell your doctor or pharmacist||
2274|122|P|your medical history, especially of: liver disease, kidney||
2274|123|P|disease, seizures, difficulty swallowing, low white blood cell||
2274|124|P|count, Parkinson's disease, dementia, certain eye problems||
2274|125|P|(cataracts, glaucoma), personal or family history of diabetes,||
2274|126|P|heart disease, high cholesterol/triglyceride levels, breathing||
2274|127|P|trouble during sleep (sleep apnea).||
2274|128|P|   Risperidone may cause a condition that affects the heart||
2274|129|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2274|130|P|serious (rarely fatal) fast/irregular heartbeat and other||
2274|131|P|symptoms (such as severe dizziness, fainting) that need medical||
2274|132|P|attention right away.||
2274|133|P|   The risk of QT prolongation may be increased if you have||
2274|134|P|certain medical conditions or are taking other drugs that may||
2274|135|P|cause QT prolongation. Before using risperidone, tell your doctor||
2274|136|P|or pharmacist of all the drugs you take and if you have any of||
2274|137|P|the following conditions: certain heart problems (heart failure,||
2274|138|P|slow heartbeat, QT prolongation in the EKG), family history of||
2274|139|P|certain heart problems (QT prolongation in the EKG, sudden||
2274|140|P|cardiac death).||
2274|141|P|   Low levels of potassium or magnesium in the blood may also||
2274|142|P|increase your risk of QT prolongation. This risk may increase if||
2274|143|P|you use certain drugs (such as diuretics/"water pills") or if you||
2274|144|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2274|145|P|Talk to your doctor about using risperidone safely.||
2274|146|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2274|147|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2274|148|P|machinery, or do anything that needs alertness until you can do||
2274|149|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2274|150|P|are using marijuana (cannabis).||
2274|151|P|   Before having surgery (including cataract/glaucoma eye||
2274|152|P|surgery), tell your doctor or dentist if you are using or have||
2274|153|P|ever used this medication, and about all the other products you||
2274|154|P|use (including prescription drugs, nonprescription drugs, and||
2274|155|P|herbal products).||
2274|156|P|   This medication may make you sweat less, making you more||
2274|157|P|likely to get heat stroke. Avoid doing things that may cause you||
2274|158|P|to overheat, such as hard work or exercise in hot weather, or||
2274|159|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2274|160|P|and dress lightly. If you overheat, quickly look for a place to||
2274|161|P|cool down and rest. Get medical help right away if you have a||
2274|162|P|fever that does not go away, mental/mood changes, headache, or||
2274|163|P|dizziness.||
2274|164|P|   Older adults may be more sensitive to the side effects of this||
2274|165|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
2274|166|P|prolongation (see above). Drowsiness, dizziness, and||
2274|167|P|lightheadedness can increase the risk of falling.||
2274|168|P|   During pregnancy, this medication should be used only when||
2274|169|P|clearly needed or if planning pregnancy within 12 weeks after||
2274|170|P|your last dose of this medication. Babies born to mothers who||
2274|171|P|have used this drug during the last 3 months of pregnancy may||
2274|172|P|rarely develop symptoms including muscle stiffness or shakiness,||
2274|173|P|drowsiness, feeding/breathing difficulties, or constant crying.||
2274|174|P|If you notice any of these symptoms in your newborn especially||
2274|175|P|during their first month, tell the doctor right away. Discuss the||
2274|176|P|risks and benefits with your doctor.||
2274|177|P|   Since untreated mental/mood problems (such as schizophrenia,||
2274|178|P|bipolar disorder) can be a serious condition, do not stop taking||
2274|179|P|this medication unless directed by your doctor. If you are||
2274|180|P|planning pregnancy, become pregnant, or think you may be||
2274|181|P|pregnant, immediately discuss with your doctor the benefits and||
2274|182|P|risks of using this medication during pregnancy.||
2274|183|P|   This medication passes into breast milk and may have||
2274|184|P|undesirable effects on a nursing infant. Tell the doctor right||
2274|185|P|away if your baby develops symptoms such as muscle stiffness or||
2274|186|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
2274|187|P|your doctor before breastfeeding (even if you have stopped this||
2274|188|P|medication within the past 12 weeks).||
2274|189|B|||
2274|190|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2274|191|I|medications work or increase your risk for serious side effects.||
2274|192|I|This document does not contain all possible drug interactions.||
2274|193|I|Keep a list of all the products you use (including||
2274|194|I|prescription/nonprescription drugs and herbal products) and share||
2274|195|I|it with your doctor and pharmacist. Do not start, stop, or change||
2274|196|I|the dosage of any medicines without your doctor's approval.||
2274|197|I|   A product that may interact with this drug is: metoclopramide.||
2274|198|I|   Tell your doctor or pharmacist if you are taking other||
2274|199|I|products that cause drowsiness such as opioid pain or cough||
2274|200|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2274|201|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2274|202|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2274|203|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2274|204|I|diphenhydramine).||
2274|205|I|   Check the labels on all your medicines (such as allergy or||
2274|206|I|cough-and-cold products) because they may contain ingredients||
2274|207|I|that cause drowsiness. Ask your pharmacist about using those||
2274|208|I|products safely.||
2274|209|B|||
2274|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2274|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2274|212|O|poison control center right away. US residents can call||
2274|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2274|214|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
2274|215|O|fast/irregular heartbeat, unusual/uncontrolled movements,||
2274|216|O|seizures.||
2274|217|B|||
2274|218|N|NOTES:  Lab and/or medical tests (such as blood sugar, weight,||
2274|219|N|blood pressure, blood cholesterol/triglyceride levels) should be||
2274|220|N|done while you are using this medication. Keep all medical and||
2274|221|N|lab appointments. Consult your doctor for more details.||
2274|222|B|||
2274|223|D|MISSED DOSE:  It is important to get each dose of this medication||
2274|224|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2274|225|D|right away for a new dosing schedule.||
2274|226|B|||
2274|227|R|STORAGE:  Not applicable. This medication is given in a hospital||
2274|228|R|or clinic and will not be stored at home.||
2274|229|B|||
2274|230|A|Information last revised October 2024.||
2274|231|A|Copyright(c) 2025 First Databank, Inc.||
2274|232|B|||
2275|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2275|002|Z|does NOT have all possible information about this product. This||
2275|003|Z|information does not assure that this product is safe, effective,||
2275|004|Z|or appropriate for you. This information is not individual||
2275|005|Z|medical advice and does not substitute for the advice of your||
2275|006|Z|health care professional. Always ask your health care||
2275|007|Z|professional for complete information about this product and your||
2275|008|Z|specific health needs.||
2275|009|B|||
2275|010|T|VILTOLARSEN - INJECTION||
2275|011|F|(VIL-toe-LAR-sen)||
2275|012|B|||
2275|013|C|COMMON BRAND NAME(S): Viltepso||
2275|014|B|||
2275|015|U|USES:  Viltolarsen is used to treat a certain inherited muscle||
2275|016|U|disorder (Duchenne muscular dystrophy-DMD). This disorder is||
2275|017|U|caused by a lack of a certain muscle protein (dystrophin). This||
2275|018|U|medication can increase the amount of dystrophin in your body.||
2275|019|B|||
2275|020|H|HOW TO USE:  This medication is given by injection into a vein by||
2275|021|H|a health care professional as directed by your doctor. It is||
2275|022|H|usually given once every week over 60 minutes. The dosage is||
2275|023|H|based on your weight.||
2275|024|H|   Tell your doctor if your condition does not get better or if||
2275|025|H|it gets worse.||
2275|026|B|||
2275|027|S|SIDE EFFECTS:  Pain/bruising/redness at the injection site,||
2275|028|S|abdominal pain, diarrhea, vomiting, or joint pain may occur. If||
2275|029|S|any of these effects last or get worse, tell your doctor or||
2275|030|S|pharmacist promptly.||
2275|031|S|   Remember that this medication has been prescribed because your||
2275|032|S|doctor has judged that the benefit to you is greater than the||
2275|033|S|risk of side effects. Many people using this medication do not||
2275|034|S|have serious side effects.||
2275|035|S|   Tell your doctor right away if you have any serious side||
2275|036|S|effects, including: signs of kidney problems (such as a change in||
2275|037|S|the amount of urine), signs of infection (such as sore throat||
2275|038|S|that doesn't go away, fever, chills), shortness of breath,||
2275|039|S|unusual tiredness.||
2275|040|S|   A very serious allergic reaction to this drug is rare.||
2275|041|S|However, get medical help right away if you notice any symptoms||
2275|042|S|of a serious allergic reaction, including: rash, itching/swelling||
2275|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2275|044|S|breathing.||
2275|045|S|   This is not a complete list of possible side effects. If you||
2275|046|S|notice other effects not listed above, contact your doctor or||
2275|047|S|pharmacist.||
2275|048|S|   In the US -||
2275|049|S|   Call your doctor for medical advice about side effects. You||
2275|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2275|051|S|www.fda.gov/medwatch.||
2275|052|S|   In Canada - Call your doctor for medical advice about side||
2275|053|S|effects. You may report side effects to Health Canada at||
2275|054|S|1-866-234-2345.||
2275|055|B|||
2275|056|P|PRECAUTIONS:  Before using viltolarsen, tell your doctor or||
2275|057|P|pharmacist if you are allergic to it; or if you have any other||
2275|058|P|allergies. This product may contain inactive ingredients, which||
2275|059|P|can cause allergic reactions or other problems. Talk to your||
2275|060|P|pharmacist for more details.||
2275|061|P|   Before using this medication, tell your doctor or pharmacist||
2275|062|P|your medical history, especially of: kidney problems.||
2275|063|P|   Before having surgery, tell your doctor or dentist about all||
2275|064|P|the products you use (including prescription drugs,||
2275|065|P|nonprescription drugs, and herbal products).||
2275|066|P|   During pregnancy, this medication should be used only when||
2275|067|P|clearly needed. Discuss the risks and benefits with your doctor.||
2275|068|P|   It is unknown if this drug passes into breast milk. Consult||
2275|069|P|your doctor before breastfeeding.||
2275|070|B|||
2275|071|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2275|072|I|medications work or increase your risk for serious side effects.||
2275|073|I|This document does not contain all possible drug interactions.||
2275|074|I|Keep a list of all the products you use (including||
2275|075|I|prescription/nonprescription drugs and herbal products) and share||
2275|076|I|it with your doctor and pharmacist. Do not start, stop, or change||
2275|077|I|the dosage of any medicines without your doctor's approval.||
2275|078|I|   This medication may interfere with certain lab tests (such as||
2275|079|I|urine protein tests), possibly causing false test results. Make||
2275|080|I|sure lab personnel and all your doctors know you use this drug.||
2275|081|B|||
2275|082|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2275|083|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2275|084|O|poison control center right away. US residents can call||
2275|085|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2275|086|B|||
2275|087|N|NOTES:  Lab and/or medical tests (such as kidney function) should||
2275|088|N|be done before you start using this medication and while you are||
2275|089|N|using it. Keep all medical and lab appointments. Consult your||
2275|090|N|doctor for more details.||
2275|091|B|||
2275|092|D|MISSED DOSE:  It is important to get each dose of this medication||
2275|093|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2275|094|D|right away for a new dosing schedule.||
2275|095|B|||
2275|096|R|STORAGE:  Not applicable. This medication is given in a clinic||
2275|097|R|and will not be stored at home.||
2275|098|B|||
2275|099|A|Information last revised April 2025.||
2275|100|A|Copyright(c) 2025 First Databank, Inc.||
2275|101|B|||
2276|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2276|002|Z|does NOT have all possible information about this product. This||
2276|003|Z|information does not assure that this product is safe, effective,||
2276|004|Z|or appropriate for you. This information is not individual||
2276|005|Z|medical advice and does not substitute for the advice of your||
2276|006|Z|health care professional. Always ask your health care||
2276|007|Z|professional for complete information about this product and your||
2276|008|Z|specific health needs.||
2276|009|B|||
2276|010|T|DEXAMETHASONE 20 MG - ORAL||
2276|011|F|(DEX-a-METH-a-sone)||
2276|012|B|||
2276|013|C|COMMON BRAND NAME(S): Hemady||
2276|014|B|||
2276|015|U|USES:  This medication is used in combination with other drugs to||
2276|016|U|treat a certain type of cancer (multiple myeloma). Dexamethasone||
2276|017|U|belongs to a class of drugs known as corticosteroids. It is used||
2276|018|U|to help your immune system control inflammation in your body. It||
2276|019|U|may also be used to reduce the risk of nausea and vomiting caused||
2276|020|U|by cancer chemotherapy.||
2276|021|B|||
2276|022|H|HOW TO USE:  Take this medication by mouth with or without food||
2276|023|H|as directed by your doctor, usually once daily on specific days,||
2276|024|H|depending on your treatment schedule. Take this medication with a||
2276|025|H|full glass of water (8 ounces/240 milliliters) unless your doctor||
2276|026|H|directs you otherwise. The dosage and schedule are based on your||
2276|027|H|medical condition and response to treatment.||
2276|028|H|   Use this medication regularly to get the most benefit from it.||
2276|029|H|To help you remember, take it at the same time each scheduled||
2276|030|H|day. Carefully follow your dosing schedule. To help you remember,||
2276|031|H|mark your calendar with a reminder.||
2276|032|H|   Do not stop taking this medication without consulting your||
2276|033|H|doctor. Some conditions may become worse when this drug is||
2276|034|H|suddenly stopped. Also, you may experience symptoms such as||
2276|035|H|nausea, dizziness, weakness, or muscle/joint pain. To prevent||
2276|036|H|these symptoms while you are stopping treatment with this drug,||
2276|037|H|your doctor may reduce your dose gradually. Consult your doctor||
2276|038|H|or pharmacist for more details. Report any new or worsening||
2276|039|H|symptoms right away.||
2276|040|B|||
2276|041|S|SIDE EFFECTS:  Stomach upset, headache, or trouble sleeping may||
2276|042|S|occur. If any of these effects last or get worse, tell your||
2276|043|S|doctor or pharmacist promptly.||
2276|044|S|   Remember that this medication has been prescribed because your||
2276|045|S|doctor has judged that the benefit to you is greater than the||
2276|046|S|risk of side effects. Many people using this medication do not||
2276|047|S|have serious side effects.||
2276|048|S|   Tell your doctor right away if you have any serious side||
2276|049|S|effects, including: signs of infection (such as sore throat that||
2276|050|S|doesn't go away, fever, chills), bone pain, easy||
2276|051|S|bruising/bleeding, unusual weight gain, puffy face, mental/mood||
2276|052|S|changes (such as depression, mood swings, agitation), menstrual||
2276|053|S|period changes, slow wound healing, thinning skin, vision||
2276|054|S|problems, muscle pain/tenderness/weakness, red/purple spots on||
2276|055|S|the skin.||
2276|056|S|   This medication may rarely make your blood sugar rise, which||
2276|057|S|can cause or worsen diabetes. Tell your doctor right away if you||
2276|058|S|have symptoms of high blood sugar such as increased||
2276|059|S|thirst/urination. If you already have diabetes, check your blood||
2276|060|S|sugar regularly as directed and share the results with your||
2276|061|S|doctor. Your doctor may need to adjust your diabetes medication,||
2276|062|S|exercise program, or diet.||
2276|063|S|   This medication may rarely cause serious problems from blood||
2276|064|S|clots (such as heart attack, stroke, blood clots in the lungs or||
2276|065|S|legs). You may be at increased risk for blood clots if you have a||
2276|066|S|history of blood clots, heart/blood vessel disease, heart||
2276|067|S|failure, stroke, if you are pregnant, or if you are immobile||
2276|068|S|(such as on very long plane flights or being bedridden). If you||
2276|069|S|use estrogen-containing products, these may also increase your||
2276|070|S|risk. Before using this medication, if you have any of these||
2276|071|S|conditions report them to your doctor or pharmacist. Get medical||
2276|072|S|help right away if any of these side effects occur: shortness of||
2276|073|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
2276|074|S|sweating, confusion, sudden dizziness/fainting,||
2276|075|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2276|076|S|trouble speaking, weakness on one side of the body, sudden vision||
2276|077|S|changes.||
2276|078|S|   A very serious allergic reaction to this drug is rare.||
2276|079|S|However, get medical help right away if you notice any symptoms||
2276|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2276|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2276|082|S|breathing.||
2276|083|S|   This is not a complete list of possible side effects. If you||
2276|084|S|notice other effects not listed above, contact your doctor or||
2276|085|S|pharmacist.||
2276|086|S|   In the US -||
2276|087|S|   Call your doctor for medical advice about side effects. You||
2276|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2276|089|S|www.fda.gov/medwatch.||
2276|090|S|   In Canada - Call your doctor for medical advice about side||
2276|091|S|effects. You may report side effects to Health Canada at||
2276|092|S|1-866-234-2345.||
2276|093|B|||
2276|094|P|PRECAUTIONS:  Before taking dexamethasone, tell your doctor or||
2276|095|P|pharmacist if you are allergic to it; or if you have any other||
2276|096|P|allergies. This product may contain inactive ingredients, which||
2276|097|P|can cause allergic reactions or other problems. Talk to your||
2276|098|P|pharmacist for more details.||
2276|099|P|   Before using this medication, tell your doctor or pharmacist||
2276|100|P|your medical history, especially of: infections (such as||
2276|101|P|tuberculosis, herpes, fungal infections), high blood pressure,||
2276|102|P|heart problems (such as heart failure, recent heart attack),||
2276|103|P|kidney disease, liver disease (such as hepatitis B), mental/mood||
2276|104|P|disorders (such as psychosis, anxiety, depression), mineral||
2276|105|P|imbalance (such as low level of potassium/calcium in the blood),||
2276|106|P|thyroid disease, stomach/intestinal problems (such as ulcer,||
2276|107|P|ulcerative colitis, diverticulitis, unexplained diarrhea),||
2276|108|P|diabetes, eye problems (such as cataracts, glaucoma), bone loss||
2276|109|P|(osteoporosis), blood clots, a certain adrenal gland tumor||
2276|110|P|(pheochromocytoma).||
2276|111|P|   Using corticosteroid medications for a long time can make it||
2276|112|P|more difficult for your body to respond to physical stress.||
2276|113|P|Before having surgery or emergency treatment, or if you get a||
2276|114|P|serious illness/injury, tell your doctor or dentist that you are||
2276|115|P|using this medication or have used this medication within the||
2276|116|P|past 12 months. Tell your doctor right away if you develop||
2276|117|P|unusual/extreme tiredness or weight loss. If you will be using||
2276|118|P|this medication for a long time, carry a warning card or medical||
2276|119|P|ID bracelet that identifies your use of this medication.||
2276|120|P|   Dexamethasone can make you more likely to get infections or||
2276|121|P|may make current infections worse. Stay away from anyone who has||
2276|122|P|an infection that may easily spread (such as chickenpox,||
2276|123|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2276|124|P|exposed to an infection or for more details.||
2276|125|P|   Tell your health care professional that you are using||
2276|126|P|dexamethasone before having any immunizations/vaccinations. Avoid||
2276|127|P|contact with people who have recently received live vaccines||
2276|128|P|(such as flu vaccine inhaled through the nose).||
2276|129|P|   This medication may cause stomach bleeding. Daily use of||
2276|130|P|alcohol while using this medication may increase your risk for||
2276|131|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
2276|132|P|or pharmacist for more information.||
2276|133|P|   Before having surgery, tell your doctor or dentist about all||
2276|134|P|the products you use (including prescription drugs,||
2276|135|P|nonprescription drugs, and herbal products).||
2276|136|P|   Older adults may be more sensitive to the side effects of this||
2276|137|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
2276|138|P|mental/mood changes (such as confusion).||
2276|139|P|   This medication may slow down a child's growth if used for a||
2276|140|P|long time. Consult the doctor or pharmacist for more details. See||
2276|141|P|the doctor regularly so your child's height and growth can be||
2276|142|P|checked.||
2276|143|P|   During pregnancy, this medication should be used only when||
2276|144|P|clearly needed. It may rarely harm an unborn baby. Your doctor||
2276|145|P|may order a pregnancy test before starting this medication. Women||
2276|146|P|of childbearing age should ask about reliable forms of birth||
2276|147|P|control while using this medication and for at least 1 month||
2276|148|P|after the last dose. Infants born to mothers who have been using||
2276|149|P|this medication for a long time may have hormone problems. Tell||
2276|150|P|your doctor right away if you notice symptoms such as||
2276|151|P|nausea/vomiting that doesn't stop, severe diarrhea, or weakness||
2276|152|P|in your newborn.||
2276|153|P|   It is unknown if this medication passes into breast milk.||
2276|154|P|Because of the possible risk to the infant, breastfeeding is not||
2276|155|P|recommended while using this medication and for at least 2 weeks||
2276|156|P|after the last dose. Consult your doctor before breastfeeding.||
2276|157|B|||
2276|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2276|159|I|medications work or increase your risk for serious side effects.||
2276|160|I|This document does not contain all possible drug interactions.||
2276|161|I|Keep a list of all the products you use (including||
2276|162|I|prescription/nonprescription drugs and herbal products) and share||
2276|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
2276|164|I|the dosage of any medicines without your doctor's approval.||
2276|165|I|   Some products that may interact with this drug are:||
2276|166|I|desmopressin, drugs that can cause bleeding/bruising (including||
2276|167|I|antiplatelet drugs such as clopidogrel, NSAIDs such as||
2276|168|I|ibuprofen/naproxen, "blood thinners" such as||
2276|169|I|warfarin/dabigatran), mifepristone.||
2276|170|I|   This medication can speed up the removal of other medications||
2276|171|I|from your body, which may affect how they work. Examples of||
2276|172|I|affected drugs include praziquantel, rilpivirine, among others.||
2276|173|I|   If your doctor has told you to take low-dose aspirin to||
2276|174|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
2276|175|I|you should keep taking the aspirin unless your doctor tells you||
2276|176|I|not to. Ask your doctor or pharmacist for more details.||
2276|177|I|   This medication may interfere with certain lab tests (such as||
2276|178|I|skin tests), possibly causing false test results. Make sure lab||
2276|179|I|personnel and all your doctors know you use this drug.||
2276|180|B|||
2276|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2276|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2276|183|O|poison control center right away. US residents can call||
2276|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2276|185|B|||
2276|186|N|NOTES:  Do not share this medication with others.||
2276|187|N|   Lab and/or medical tests (such as blood mineral levels, blood||
2276|188|N|sugar, complete blood count, bone density, blood pressure, eye||
2276|189|N|exams) should be done while you are taking this medication. Keep||
2276|190|N|all medical and lab appointments.||
2276|191|N|   This medication may cause bone loss (osteoporosis) when used||
2276|192|N|for a long time. Lifestyle changes that may help reduce the risk||
2276|193|N|of bone problems include doing weight-bearing exercise, stopping||
2276|194|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2276|195|N|D. Talk to your doctor for more details.||
2276|196|B|||
2276|197|D|MISSED DOSE:  It is important to take each dose of this||
2276|198|D|medication as scheduled. If you miss a dose, ask your doctor or||
2276|199|D|pharmacist right away for a new dosing schedule.||
2276|200|B|||
2276|201|R|STORAGE:  Store at room temperature away from light and moisture.||
2276|202|R|Do not store in the bathroom. Keep all medications away from||
2276|203|R|children and pets.||
2276|204|R|   Do not flush medications down the toilet or pour them into a||
2276|205|R|drain unless instructed to do so. Properly discard this product||
2276|206|R|when it is expired or no longer needed. Consult your pharmacist||
2276|207|R|or local waste disposal company.||
2276|208|B|||
2276|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
2276|210|M|medical emergency. For information about enrolling in MedicAlert,||
2276|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2276|212|B|||
2276|213|A|Information last revised September 2025.||
2276|214|A|Copyright(c) 2025 First Databank, Inc.||
2276|215|B|||
2277|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2277|002|Z|does NOT have all possible information about this product. This||
2277|003|Z|information does not assure that this product is safe, effective,||
2277|004|Z|or appropriate for you. This information is not individual||
2277|005|Z|medical advice and does not substitute for the advice of your||
2277|006|Z|health care professional. Always ask your health care||
2277|007|Z|professional for complete information about this product and your||
2277|008|Z|specific health needs.||
2277|009|B|||
2277|010|T|OPICAPONE - ORAL||
2277|011|F|(oh-PIK-a-pone)||
2277|012|B|||
2277|013|C|COMMON BRAND NAME(S): Ongentys||
2277|014|B|||
2277|015|U|USES:  This medication is used with other medications||
2277|016|U|(levodopa/carbidopa) to treat Parkinson's disease. Opicapone||
2277|017|U|belongs to a class of drugs known as COMT inhibitors. Many people||
2277|018|U|taking levodopa for Parkinson's disease have problems with the||
2277|019|U|effects of levodopa wearing off between scheduled doses, which||
2277|020|U|causes symptoms to return or get worse. Opicapone blocks a||
2277|021|U|certain natural substance (COMT) that breaks down levodopa in the||
2277|022|U|body. This effect helps levodopa to work better and for a longer||
2277|023|U|time.||
2277|024|B|||
2277|025|H|HOW TO USE:  Take this medication by mouth on an empty stomach as||
2277|026|H|directed by your doctor, usually once daily at bedtime. Do not||
2277|027|H|eat food for 1 hour before and at least 1 hour after taking||
2277|028|H|opicapone. The dosage is based on your medical condition and||
2277|029|H|response to treatment.||
2277|030|H|   Use this medication regularly to get the most benefit from it.||
2277|031|H|To help you remember, take it at the same time each day. Do not||
2277|032|H|suddenly stop taking this medication unless instructed by your||
2277|033|H|doctor. Doing so may cause side effects (such as fever, severe||
2277|034|H|muscle stiffness) or make your Parkinson's symptoms get worse.||
2277|035|H|   Tell your doctor if your condition does not get better or if||
2277|036|H|it gets worse.||
2277|037|B|||
2277|038|S|SIDE EFFECTS:  Unwanted/uncontrolled movements, constipation,||
2277|039|S|drowsiness, dizziness, or weight loss may occur. If any of these||
2277|040|S|effects last or get worse, tell your doctor or pharmacist||
2277|041|S|promptly.||
2277|042|S|   To reduce the risk of dizziness and lightheadedness, get up||
2277|043|S|slowly when rising from a sitting or lying position.||
2277|044|S|   Remember that this medication has been prescribed because your||
2277|045|S|doctor has judged that the benefit to you is greater than the||
2277|046|S|risk of side effects. Many people using this medication do not||
2277|047|S|have serious side effects.||
2277|048|S|   Some people taking this medication along with||
2277|049|S|levodopa/carbidopa have fallen asleep suddenly during their usual||
2277|050|S|daily activities (such as talking, eating, driving). In some||
2277|051|S|cases, sleep occurred without any feelings of drowsiness||
2277|052|S|beforehand. This sleep effect may occur anytime during treatment||
2277|053|S|with opicapone and levodopa/carbidopa even if you have used these||
2277|054|S|medications for a long time. If you experience increased||
2277|055|S|sleepiness or fall asleep during the day, do not drive or do||
2277|056|S|other possibly dangerous activities until you have discussed this||
2277|057|S|effect with your doctor. Your risk of this sleep effect is||
2277|058|S|increased by using alcohol or other medications that can make you||
2277|059|S|drowsy. See also Precautions section.||
2277|060|S|   Tell your doctor right away if you have any serious side||
2277|061|S|effects, including: fast/irregular heartbeat, mental/mood changes||
2277|062|S|(such as agitation, confusion, hallucinations), unusual strong||
2277|063|S|urges (such as increased gambling, uncontrolled spending, binge||
2277|064|S|eating, increased sexual urges).||
2277|065|S|   A very serious allergic reaction to this drug is rare.||
2277|066|S|However, get medical help right away if you notice any symptoms||
2277|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2277|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2277|069|S|breathing.||
2277|070|S|   This is not a complete list of possible side effects. If you||
2277|071|S|notice other effects not listed above, contact your doctor or||
2277|072|S|pharmacist.||
2277|073|S|   In the US -||
2277|074|S|   Call your doctor for medical advice about side effects. You||
2277|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2277|076|S|www.fda.gov/medwatch.||
2277|077|S|   In Canada - Call your doctor for medical advice about side||
2277|078|S|effects. You may report side effects to Health Canada at||
2277|079|S|1-866-234-2345.||
2277|080|B|||
2277|081|P|PRECAUTIONS:  Before taking opicapone, tell your doctor or||
2277|082|P|pharmacist if you are allergic to it; or if you have any other||
2277|083|P|allergies. This product may contain inactive ingredients, which||
2277|084|P|can cause allergic reactions or other problems. Talk to your||
2277|085|P|pharmacist for more details.||
2277|086|P|   Before using this medication, tell your doctor or pharmacist||
2277|087|P|your medical history, especially of: kidney problems, liver||
2277|088|P|problems, mental/mood problems (such as psychosis,||
2277|089|P|hallucinations), sleep disorder, uncontrolled sudden movements,||
2277|090|P|certain types of tumors (such as pheochromocytoma,||
2277|091|P|paraganglioma).||
2277|092|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2277|093|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2277|094|P|machinery, or do anything that needs alertness until you can do||
2277|095|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2277|096|P|are using marijuana (cannabis).||
2277|097|P|   Before having surgery, tell your doctor or dentist about all||
2277|098|P|the products you use (including prescription drugs,||
2277|099|P|nonprescription drugs, and herbal products).||
2277|100|P|   During pregnancy, this medication should be used only when||
2277|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
2277|102|P|   It is unknown if this medication passes into breast milk.||
2277|103|P|Consult your doctor before breastfeeding.||
2277|104|B|||
2277|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2277|106|I|medications work or increase your risk for serious side effects.||
2277|107|I|This document does not contain all possible drug interactions.||
2277|108|I|Keep a list of all the products you use (including||
2277|109|I|prescription/nonprescription drugs and herbal products) and share||
2277|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
2277|111|I|the dosage of any medicines without your doctor's approval.||
2277|112|I|   Taking MAO inhibitors with this medication may cause a serious||
2277|113|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2277|114|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2277|115|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
2277|116|I|treatment with this medication. Most MAO inhibitors should also||
2277|117|I|not be taken for two weeks before treatment with this medication.||
2277|118|I|However, certain MAO inhibitors (rasagiline, safinamide,||
2277|119|I|selegiline) may be used with careful monitoring by your doctor.||
2277|120|I|   Tell your doctor or pharmacist if you are using other products||
2277|121|I|that cause drowsiness such as opioid pain or cough relievers||
2277|122|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2277|123|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2277|124|I|zolpidem), muscle relaxants (such as carisoprodol,||
2277|125|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2277|126|I|diphenhydramine).||
2277|127|I|   Check the labels on all your medicines (such as allergy or||
2277|128|I|cough-and-cold products) because they may contain ingredients||
2277|129|I|that cause drowsiness. Ask your pharmacist about using those||
2277|130|I|products safely.||
2277|131|B|||
2277|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2277|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2277|134|O|poison control center right away. US residents can call||
2277|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2277|136|B|||
2277|137|N|NOTES:  Do not share this medication with others.||
2277|138|N|   Lab and/or medical tests (such as blood pressure, liver||
2277|139|N|function) should be done while you are taking this medication.||
2277|140|N|Keep all medical and lab appointments.||
2277|141|B|||
2277|142|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2277|143|D|next dose at the regular time (the next day at bedtime). Do not||
2277|144|D|double the dose to catch up.||
2277|145|B|||
2277|146|R|STORAGE:  Store at room temperature away from light and moisture.||
2277|147|R|Do not store in the bathroom. Keep all medications away from||
2277|148|R|children and pets.||
2277|149|R|   Do not flush medications down the toilet or pour them into a||
2277|150|R|drain unless instructed to do so. Properly discard this product||
2277|151|R|when it is expired or no longer needed. Consult your pharmacist||
2277|152|R|or local waste disposal company.||
2277|153|B|||
2277|154|A|Information last revised May 2024.||
2277|155|A|Copyright(c) 2025 First Databank, Inc.||
2277|156|B|||
2278|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2278|002|Z|does NOT have all possible information about this product. This||
2278|003|Z|information does not assure that this product is safe, effective,||
2278|004|Z|or appropriate for you. This information is not individual||
2278|005|Z|medical advice and does not substitute for the advice of your||
2278|006|Z|health care professional. Always ask your health care||
2278|007|Z|professional for complete information about this product and your||
2278|008|Z|specific health needs.||
2278|009|B|||
2278|010|T|OXYCODONE EXTENDED-RELEASE - ORAL||
2278|011|F|(ox-ee-KOH-doan)||
2278|012|B|||
2278|013|C|COMMON BRAND NAME(S): Oxycontin||
2278|014|B|||
2278|015|W|WARNING:  Oxycodone has a risk for abuse and addiction, which can||
2278|016|W|lead to overdose and death. Oxycodone may also cause severe,||
2278|017|W|possibly fatal, breathing problems. To lower your risk, your||
2278|018|W|doctor should have you take the smallest dose of oxycodone that||
2278|019|W|works, and take it for the shortest possible time. See also How||
2278|020|W|to Use section for more information about addiction.||
2278|021|W|   Ask your doctor or pharmacist if you should have medication||
2278|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
2278|023|W|Teach your family or household members about the signs of an||
2278|024|W|opioid overdose and how to treat it.||
2278|025|W|   The risk for severe breathing problems is higher when you||
2278|026|W|start this medication and after a dose increase, or if you take||
2278|027|W|the wrong dose/strength. Taking this medication with alcohol or||
2278|028|W|other drugs that can cause drowsiness or breathing problems may||
2278|029|W|cause very serious side effects, including death. Also, other||
2278|030|W|medications can affect the removal of oxycodone from your body,||
2278|031|W|which may affect how oxycodone works. Be sure you know how to||
2278|032|W|take oxycodone and what other drugs you should avoid taking with||
2278|033|W|it. See also Drug Interactions section. Get medical help right||
2278|034|W|away if any of these very serious side effects occur:||
2278|035|W|slow/shallow breathing, unusual lightheadedness, severe||
2278|036|W|drowsiness/dizziness, difficulty waking up.||
2278|037|W|   Do not break, crush, chew, or dissolve this medication. Taking||
2278|038|W|broken, crushed, chewed, or dissolved extended-release oxycodone||
2278|039|W|could cause a fatal overdose.||
2278|040|W|   Keep this medicine in a safe place to prevent theft, misuse,||
2278|041|W|or abuse. If someone accidentally swallows this drug, get medical||
2278|042|W|help right away.||
2278|043|W|   Before using this medication, women of childbearing age should||
2278|044|W|talk with their doctor(s) about the risks and benefits. Tell your||
2278|045|W|doctor if you are pregnant or if you plan to become pregnant.||
2278|046|W|During pregnancy, this medication should be used only when||
2278|047|W|clearly needed. It may slightly increase the risk of birth||
2278|048|W|defects if used during the first two months of pregnancy. Also,||
2278|049|W|using it for a long time or in high doses near the expected||
2278|050|W|delivery date may harm the unborn baby. To lessen the risk, take||
2278|051|W|the smallest effective dose for the shortest possible time.||
2278|052|W|Babies born to mothers who use this drug for a long time may||
2278|053|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
2278|054|W|doctor right away if you notice any symptoms in your newborn baby||
2278|055|W|such as crying that doesn't stop, slow/shallow breathing,||
2278|056|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
2278|057|W|difficulty gaining weight.||
2278|058|B|||
2278|059|U|USES:  This medication is used to help relieve severe ongoing||
2278|060|U|pain (such as due to cancer). Oxycodone belongs to a class of||
2278|061|U|drugs known as opioid analgesics. It works in the brain to change||
2278|062|U|how your body feels and responds to pain.||
2278|063|U|   The higher strengths of this drug (more than 40 milligrams per||
2278|064|U|tablet) should be used only if you have been regularly taking||
2278|065|U|moderate to large amounts of an opioid pain medication. These||
2278|066|U|strengths may cause overdose (even death) if taken by a person||
2278|067|U|who has not been regularly taking opioids.||
2278|068|U|   Do not use the extended-release form of oxycodone to relieve||
2278|069|U|pain that is mild or that will go away in a few days. This||
2278|070|U|medication is not for occasional ("as needed") use.||
2278|071|B|||
2278|072|H|HOW TO USE:  See also Warning section.||
2278|073|H|   Read the Medication Guide provided by your pharmacist before||
2278|074|H|you start taking extended-release oxycodone and each time you get||
2278|075|H|a refill. If you have any questions, ask your doctor or||
2278|076|H|pharmacist.||
2278|077|H|   Take this medication on a regular schedule as directed by your||
2278|078|H|doctor, not as needed for sudden (breakthrough) pain. Take this||
2278|079|H|drug with or without food, usually every 12 hours. If you have||
2278|080|H|nausea, it may help to take this drug with food. Ask your doctor||
2278|081|H|or pharmacist about other ways to decrease nausea (such as lying||
2278|082|H|down for 1 to 2 hours with as little head movement as possible).||
2278|083|H|If nausea lasts, see your doctor.||
2278|084|H|   Swallow the tablets whole. Do not break, crush, chew, or||
2278|085|H|dissolve the tablets. Doing so can release all of the drug at||
2278|086|H|once, increasing the risk of oxycodone overdose.||
2278|087|H|   To lessen the chance of choking or having trouble swallowing||
2278|088|H|the tablet, take only one a tablet at a time if your dose is for||
2278|089|H|more than one tablet. Do not pre-soak, lick, or wet the tablet||
2278|090|H|before placing it in your mouth. Be sure to drink enough water||
2278|091|H|with each tablet to swallow it completely.||
2278|092|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2278|093|H|using this medication unless your doctor or pharmacist says you||
2278|094|H|may do so safely. Grapefruit can increase the chance of side||
2278|095|H|effects with this medicine. Ask your doctor or pharmacist for||
2278|096|H|more details.||
2278|097|H|   The dosage is based on your medical condition and response to||
2278|098|H|treatment. Do not increase your dose, take the medication more||
2278|099|H|often, or take it for a longer time than prescribed. Properly||
2278|100|H|stop the medication when so directed.||
2278|101|H|   Before you start taking this medication, ask your doctor or||
2278|102|H|pharmacist if you should stop or change how you use your other||
2278|103|H|opioid medication(s). Other pain relievers (such as||
2278|104|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
2278|105|H|or pharmacist about using oxycodone safely with other drugs.||
2278|106|H|   Suddenly stopping this medication may cause withdrawal,||
2278|107|H|especially if you have used it for a long time or in high doses.||
2278|108|H|To prevent withdrawal, your doctor may lower your dose slowly.||
2278|109|H|Tell your doctor or pharmacist right away if you have any||
2278|110|H|withdrawal symptoms such as restlessness, mental/mood changes||
2278|111|H|(including anxiety, trouble sleeping, thoughts of suicide),||
2278|112|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
2278|113|H|aches, or sudden changes in behavior.||
2278|114|H|   When this medication is used for a long time, it may not work||
2278|115|H|as well. Talk with your doctor if this medication stops working||
2278|116|H|well.||
2278|117|H|   Though it helps many people, this medication may sometimes||
2278|118|H|cause addiction. This risk may be higher if you have a||
2278|119|H|mental/mood disorder or a substance use disorder (such as overuse||
2278|120|H|of or addiction to drugs/alcohol). Take this medication exactly||
2278|121|H|as prescribed to lower the risk of addiction. Ask your doctor or||
2278|122|H|pharmacist for more details.||
2278|123|H|   Tell your doctor if your pain does not get better or if it||
2278|124|H|gets worse, or if you have any new pain.||
2278|125|B|||
2278|126|S|SIDE EFFECTS:  See also Warning section.||
2278|127|S|   Nausea, vomiting, constipation, dry mouth, weakness, sweating,||
2278|128|S|lightheadedness, dizziness, or drowsiness may occur. Some of||
2278|129|S|these side effects may decrease after you have been using this||
2278|130|S|medication for a while. If any of these effects last or get||
2278|131|S|worse, tell your doctor or pharmacist promptly.||
2278|132|S|   To prevent constipation, eat dietary fiber, drink enough||
2278|133|S|water, and exercise. You may also need to take a laxative. Ask||
2278|134|S|your pharmacist which type of laxative is right for you.||
2278|135|S|   To reduce the risk of dizziness and lightheadedness, get up||
2278|136|S|slowly when rising from a sitting or lying position.||
2278|137|S|   You may notice an empty tablet shell in your stool. This is||
2278|138|S|harmless because your body has already absorbed the medicine.||
2278|139|S|   Remember that this medication has been prescribed because your||
2278|140|S|doctor has judged that the benefit to you is greater than the||
2278|141|S|risk of side effects. Many people using this medication do not||
2278|142|S|have serious side effects.||
2278|143|S|   Tell your doctor right away if you have any serious side||
2278|144|S|effects, including: interrupted breathing during sleep (sleep||
2278|145|S|apnea), mental/mood changes (such as agitation, confusion,||
2278|146|S|hallucinations), severe stomach/abdominal pain, difficulty||
2278|147|S|urinating, signs of your adrenal glands not working well (such as||
2278|148|S|loss of appetite, unusual tiredness, weight loss), trouble||
2278|149|S|swallowing.||
2278|150|S|   Get medical help right away if you have any very serious side||
2278|151|S|effects, including: fainting, seizure, slow/shallow breathing,||
2278|152|S|severe drowsiness/difficulty waking up.||
2278|153|S|   A very serious allergic reaction to this drug is rare.||
2278|154|S|However, get medical help right away if you notice any symptoms||
2278|155|S|of a serious allergic reaction, including: rash, itching/swelling||
2278|156|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2278|157|S|breathing.||
2278|158|S|   This is not a complete list of possible side effects. If you||
2278|159|S|notice other effects not listed above, contact your doctor or||
2278|160|S|pharmacist.||
2278|161|S|   In the US -||
2278|162|S|   Call your doctor for medical advice about side effects. You||
2278|163|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2278|164|S|www.fda.gov/medwatch.||
2278|165|S|   In Canada - Call your doctor for medical advice about side||
2278|166|S|effects. You may report side effects to Health Canada at||
2278|167|S|1-866-234-2345.||
2278|168|B|||
2278|169|P|PRECAUTIONS:  Before taking oxycodone, tell your doctor or||
2278|170|P|pharmacist if you are allergic to it; or to other opioid pain||
2278|171|P|relievers (such as oxymorphone); or if you have any other||
2278|172|P|allergies. This product may contain inactive ingredients, which||
2278|173|P|can cause allergic reactions or other problems. Talk to your||
2278|174|P|pharmacist for more details.||
2278|175|P|   Before using this medication, tell your doctor or pharmacist||
2278|176|P|your medical history, especially of: brain disorders (such as||
2278|177|P|head injury, tumor, seizures), breathing problems (such as||
2278|178|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
2278|179|P|kidney disease, liver disease, mental/mood disorders (such as||
2278|180|P|confusion, depression), personal or family history of a substance||
2278|181|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
2278|182|P|stomach/intestinal problems (such as blockage, constipation,||
2278|183|P|diarrhea due to infection, paralytic ileus), difficulty||
2278|184|P|swallowing, difficulty urinating (such as due to enlarged||
2278|185|P|prostate), disease of the pancreas (pancreatitis), gallbladder||
2278|186|P|disease.||
2278|187|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2278|188|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2278|189|P|machinery, or do anything that needs alertness until you can do||
2278|190|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2278|191|P|are using marijuana (cannabis).||
2278|192|P|   Before having surgery, tell your doctor or dentist about all||
2278|193|P|the products you use (including prescription drugs,||
2278|194|P|nonprescription drugs, and herbal products).||
2278|195|P|   Older adults may be more sensitive to the side effects of this||
2278|196|P|drug, especially confusion, dizziness, drowsiness, and||
2278|197|P|slow/shallow breathing.||
2278|198|P|   During pregnancy, this medication should be used only when||
2278|199|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2278|200|P|benefits with your doctor. (See also Warning section.)||
2278|201|P|   This drug passes into breast milk and may have undesirable||
2278|202|P|effects on a nursing infant. Tell the doctor right away if your||
2278|203|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
2278|204|P|breathing. Consult your doctor before breastfeeding.||
2278|205|B|||
2278|206|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
2278|207|I|   Drug interactions may change how your medications work or||
2278|208|I|increase your risk for serious side effects. This document does||
2278|209|I|not contain all possible drug interactions. Keep a list of all||
2278|210|I|the products you use (including prescription/nonprescription||
2278|211|I|drugs and herbal products) and share it with your doctor and||
2278|212|I|pharmacist. Do not start, stop, or change the dosage of any||
2278|213|I|medicines without your doctor's approval.||
2278|214|I|   Some products that may interact with this drug include:||
2278|215|I|certain pain medications (mixed opioid agonist/antagonists such||
2278|216|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
2278|217|I|samidorphan.||
2278|218|I|   The risk of serious side effects (such as slow/shallow||
2278|219|I|breathing, severe drowsiness/dizziness) may be increased if this||
2278|220|I|medication is taken with other products that may also cause||
2278|221|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2278|222|I|if you are taking other products such as other opioid pain or||
2278|223|I|cough relievers (such as codeine, hydrocodone), alcohol,||
2278|224|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
2278|225|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2278|226|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2278|227|I|cetirizine, diphenhydramine).||
2278|228|I|   Check the labels on all your medicines (such as allergy or||
2278|229|I|cough-and-cold products) because they may contain ingredients||
2278|230|I|that cause drowsiness. Ask your pharmacist about using those||
2278|231|I|products safely.||
2278|232|I|   Other medications can affect the removal of oxycodone from||
2278|233|I|your body, which may affect how oxycodone works. Examples include||
2278|234|I|azole antifungals (such as ketoconazole), macrolide antibiotics||
2278|235|I|(such as erythromycin), mifepristone, HIV medications (such as||
2278|236|I|tipranavir), rifamycins (such as rifabutin, rifampin), ritonavir,||
2278|237|I|certain drugs used to treat seizures (such as carbamazepine,||
2278|238|I|phenytoin), among others.||
2278|239|I|   This medication may interfere with certain lab tests (such as||
2278|240|I|amylase/lipase levels), possibly causing false test results. Make||
2278|241|I|sure lab personnel and all your doctors know you use this drug.||
2278|242|B|||
2278|243|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2278|244|O|as passing out or trouble breathing, give them naloxone or||
2278|245|O|nalmefene if available, then call 911. If the person is awake and||
2278|246|O|has no symptoms, call a poison control center right away. US||
2278|247|O|residents can call 1-800-222-1222. Canada residents can call||
2278|248|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
2278|249|O|breathing, slow heartbeat, coma.||
2278|250|B|||
2278|251|N|NOTES:  Do not share this medication with others. Sharing it is||
2278|252|N|against the law.||
2278|253|N|   This medication has been prescribed for your current condition||
2278|254|N|only. Do not use it later for another condition unless told to do||
2278|255|N|so by your doctor. A different medication may be necessary in||
2278|256|N|that case.||
2278|257|B|||
2278|258|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2278|259|D|next dose at the regular time. Do not double the dose to catch||
2278|260|D|up.||
2278|261|B|||
2278|262|R|STORAGE:  Store at room temperature away from light and moisture.||
2278|263|R|Do not store in the bathroom. Keep all medications away from||
2278|264|R|children and pets. See also Warning section.||
2278|265|R|   Do not flush medications down the toilet or pour them into a||
2278|266|R|drain unless instructed to do so. Properly discard this product||
2278|267|R|when it is expired or no longer needed. For more details, read||
2278|268|R|the Medication Guide, or consult your pharmacist or local waste||
2278|269|R|disposal company.||
2278|270|B|||
2278|271|A|Information last revised August 2025.||
2278|272|A|Copyright(c) 2025 First Databank, Inc.||
2278|273|B|||
2279|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2279|002|Z|does NOT have all possible information about this product. This||
2279|003|Z|information does not assure that this product is safe, effective,||
2279|004|Z|or appropriate for you. This information is not individual||
2279|005|Z|medical advice and does not substitute for the advice of your||
2279|006|Z|health care professional. Always ask your health care||
2279|007|Z|professional for complete information about this product and your||
2279|008|Z|specific health needs.||
2279|009|B|||
2279|010|T|RIBAVIRIN CAPSULE - ORAL||
2279|011|F|(rye-buh-VYE-rin)||
2279|012|B|||
2279|013|C|COMMON BRAND NAME(S): Rebetol||
2279|014|B|||
2279|015|W|WARNING:  Ribavirin may cause birth defects and/or death in||
2279|016|W|unborn babies that are exposed to it during pregnancy. If you or||
2279|017|W|your sexual partner are or may be pregnant, do not take||
2279|018|W|ribavirin, and contact your doctor right away. Women using this||
2279|019|W|medication must avoid pregnancy by using reliable forms of birth||
2279|020|W|control during treatment and for 9 months after this medication||
2279|021|W|is stopped. Men using this medication must avoid causing||
2279|022|W|pregnancy by using reliable forms of birth control during||
2279|023|W|treatment and for 6 months after this medication is stopped.||
2279|024|W|Consult your doctor or pharmacist for more information.||
2279|025|W|   Patients with certain types of heart disease should not use||
2279|026|W|ribavirin because it can lower your red blood cell level||
2279|027|W|(anemia). This may worsen your condition and can lead to a||
2279|028|W|possibly fatal heart attack. Before using this medication, tell||
2279|029|W|your doctor if you have had any heart problems or chest pain.||
2279|030|W|   Ribavirin should never be used alone to treat hepatitis C||
2279|031|W|infections.||
2279|032|B|||
2279|033|U|USES:  Ribavirin is used in combination with other antiviral||
2279|034|U|medications (such as interferon, sofosbuvir) to treat chronic||
2279|035|U|(long-lasting) hepatitis C, a viral infection of the liver.||
2279|036|U|Chronic hepatitis C infection can cause serious liver problems||
2279|037|U|such as scarring (cirrhosis), or liver cancer. Ribavirin works by||
2279|038|U|reducing the amount of hepatitis C virus in your body, which may||
2279|039|U|help your liver recover.||
2279|040|U|   It is not known if this treatment can prevent you from passing||
2279|041|U|the virus to others. Do not share needles, and practice "safer||
2279|042|U|sex" (including the use of latex condoms) to lower the risk of||
2279|043|U|passing the virus to others.||
2279|044|B|||
2279|045|V|OTHER USES:  This section contains uses of this drug that are not||
2279|046|V|listed in the approved professional labeling for the drug but||
2279|047|V|that may be prescribed by your health care professional. Use this||
2279|048|V|drug for a condition that is listed in this section only if it||
2279|049|V|has been so prescribed by your health care professional.||
2279|050|V|   This drug may also be used for severe acute respiratory||
2279|051|V|syndrome (SARS).||
2279|052|B|||
2279|053|H|HOW TO USE:  Read the Medication Guide provided by your||
2279|054|H|pharmacist before you start taking ribavirin and each time you||
2279|055|H|get a refill. If you have any questions, ask your doctor or||
2279|056|H|pharmacist. Also read the drug information for your other||
2279|057|H|antiviral medication(s).||
2279|058|H|   Take this medication by mouth as directed by your doctor,||
2279|059|H|usually twice daily with food. Swallow this medication whole. Do||
2279|060|H|not crush, break or chew the capsules.||
2279|061|H|   The dosage and length of treatment is based on your age,||
2279|062|H|weight, medical condition, and response to treatment.||
2279|063|H|   This medication works best when the amount of drug in your||
2279|064|H|body is kept at a constant level. Take this drug at evenly spaced||
2279|065|H|intervals. To help you remember, take it at the same times each||
2279|066|H|day.||
2279|067|H|   Continue to take ribavirin and your other antiviral||
2279|068|H|medication(s) for the full length of time prescribed, even if||
2279|069|H|your symptoms disappear after a short time. Stopping any of the||
2279|070|H|drugs too early may result in a return of the infection.||
2279|071|H|   Drink plenty of water while being treated with this||
2279|072|H|medication. Doing so will decrease the risk of serious side||
2279|073|H|effects.||
2279|074|B|||
2279|075|S|SIDE EFFECTS:  Nausea, diarrhea, stomach upset, headache,||
2279|076|S|dizziness, blurred vision, trouble sleeping, cough, low appetite,||
2279|077|S|weight loss or gain, dry skin, or changes in taste/hearing may||
2279|078|S|occur. If any of these effects last or get worse, tell your||
2279|079|S|doctor or pharmacist promptly.||
2279|080|S|   Remember that this medication has been prescribed because your||
2279|081|S|doctor has judged that the benefit to you is greater than the||
2279|082|S|risk of side effects. Many people using this medication do not||
2279|083|S|have serious side effects.||
2279|084|S|   Tell your doctor right away if you have any serious side||
2279|085|S|effects, including: unusual tiredness/weakness,||
2279|086|S|fast/pounding/irregular heartbeat, muscle/joint pain, vision||
2279|087|S|changes, easy bruising/bleeding, dark urine, yellowing of||
2279|088|S|eyes/skin.||
2279|089|S|   Get medical help right away if you have any very serious side||
2279|090|S|effects, including: chest pain, jaw/left arm pain, stomach/lower||
2279|091|S|back pain, black/bloody stools.||
2279|092|S|   A very serious allergic reaction to this drug is rare.||
2279|093|S|However, get medical help right away if you notice any symptoms||
2279|094|S|of a serious allergic reaction, including: rash, itching/swelling||
2279|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2279|096|S|breathing.||
2279|097|S|   This is not a complete list of possible side effects. If you||
2279|098|S|notice other effects not listed above, contact your doctor or||
2279|099|S|pharmacist.||
2279|100|S|   In the US -||
2279|101|S|   Call your doctor for medical advice about side effects. You||
2279|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2279|103|S|www.fda.gov/medwatch.||
2279|104|S|   In Canada - Call your doctor for medical advice about side||
2279|105|S|effects. You may report side effects to Health Canada at||
2279|106|S|1-866-234-2345.||
2279|107|B|||
2279|108|P|PRECAUTIONS:  Before taking ribavirin, tell your doctor or||
2279|109|P|pharmacist if you are allergic to it; or if you have any other||
2279|110|P|allergies. This product may contain inactive ingredients, which||
2279|111|P|can cause allergic reactions or other problems. Talk to your||
2279|112|P|pharmacist for more details.||
2279|113|P|   Before using this medication, tell your doctor or pharmacist||
2279|114|P|your medical history, especially of: blood disorders (such as||
2279|115|P|sickle cell anemia, low hemoglobin, thalassemia), kidney disease,||
2279|116|P|other liver problems (such as autoimmune hepatitis), heart||
2279|117|P|disease, high blood pressure, breathing problems, pancreas||
2279|118|P|problems (such as pancreatitis), diabetes.||
2279|119|P|   This drug may make you dizzy or blur your vision. Alcohol or||
2279|120|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
2279|121|P|machinery, or do anything that needs alertness or clear vision||
2279|122|P|until you can do it safely. Avoid alcoholic beverages. Talk to||
2279|123|P|your doctor if you are using marijuana (cannabis).||
2279|124|P|   Older adults may be at greater risk for anemia while using||
2279|125|P|this drug.||
2279|126|P|   Ribavirin must not be used during pregnancy. It is recommended||
2279|127|P|that female patients or female partners of male patients take a||
2279|128|P|pregnancy test before this medication is started. Pregnancy tests||
2279|129|P|should continue to be done while using this medication and for||
2279|130|P|some time after this medication is stopped (for 9 months for||
2279|131|P|female patients and for 6 months for female partners of male||
2279|132|P|patients). If you or your partner become pregnant, or if you||
2279|133|P|think you or your partner may be pregnant, tell your doctor right||
2279|134|P|away. See also Warning section.||
2279|135|P|   It is unknown if this drug passes into breast milk. Consult||
2279|136|P|your doctor before breastfeeding.||
2279|137|B|||
2279|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2279|139|I|medications work or increase your risk for serious side effects.||
2279|140|I|This document does not contain all possible drug interactions.||
2279|141|I|Keep a list of all the products you use (including||
2279|142|I|prescription/nonprescription drugs and herbal products) and share||
2279|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
2279|144|I|the dosage of any medicines without your doctor's approval.||
2279|145|I|   Some products that may interact with this drug include:||
2279|146|I|antacids, didanosine, zidovudine.||
2279|147|B|||
2279|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2279|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2279|150|O|poison control center right away. US residents can call||
2279|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2279|152|B|||
2279|153|N|NOTES:  Do not share this medication with others.||
2279|154|N|   Lab and/or medical tests (such as pregnancy, blood||
2279|155|N|counts/hemoglobin, liver/thyroid/heart function, EKG, eye exams)||
2279|156|N|should be done while you are taking this medication. Keep all||
2279|157|N|medical and lab appointments. Consult your doctor for more||
2279|158|N|details.||
2279|159|N|   This medication has been prescribed for your current condition||
2279|160|N|only. Do not use it later for another infection unless your||
2279|161|N|doctor tells you to.||
2279|162|B|||
2279|163|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2279|164|D|If it is near the time of the next dose, skip the missed dose.||
2279|165|D|Use your next dose at the regular time. Do not double the dose to||
2279|166|D|catch up.||
2279|167|B|||
2279|168|R|STORAGE:  Store at room temperature away from light and moisture.||
2279|169|R|Do not store in the bathroom. Keep all medications away from||
2279|170|R|children and pets.||
2279|171|R|   Do not flush medications down the toilet or pour them into a||
2279|172|R|drain unless instructed to do so. Properly discard this product||
2279|173|R|when it is expired or no longer needed. Consult your pharmacist||
2279|174|R|or local waste disposal company.||
2279|175|B|||
2279|176|A|Information last revised May 2024.||
2279|177|A|Copyright(c) 2025 First Databank, Inc.||
2279|178|B|||
2280|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2280|002|Z|does NOT have all possible information about this product. This||
2280|003|Z|information does not assure that this product is safe, effective,||
2280|004|Z|or appropriate for you. This information is not individual||
2280|005|Z|medical advice and does not substitute for the advice of your||
2280|006|Z|health care professional. Always ask your health care||
2280|007|Z|professional for complete information about this product and your||
2280|008|Z|specific health needs.||
2280|009|B|||
2280|010|T|METOCLOPRAMIDE SPRAY - NASAL||
2280|011|F|(MET-oh-KLOE-pra-mide)||
2280|012|B|||
2280|013|C|COMMON BRAND NAME(S): Gimoti||
2280|014|B|||
2280|015|W|WARNING:  This medication may cause a serious movement disorder||
2280|016|W|called tardive dyskinesia. In some cases, this condition may be||
2280|017|W|permanent. The risk of tardive dyskinesia is increased with the||
2280|018|W|longer use of the medication and the more medication that you||
2280|019|W|use. The risk is also increased in older adults (especially||
2280|020|W|women) and in people with diabetes. Metoclopramide comes in||
2280|021|W|different forms (such as tablets, solution, injection). Do not||
2280|022|W|use metoclopramide products for longer than 12 weeks. Talk to||
2280|023|W|your doctor about the risks and benefits of this medication.||
2280|024|W|   Tell your doctor right away if you develop any unusual||
2280|025|W|uncontrolled movements (especially of the face, mouth, tongue,||
2280|026|W|arms, or legs). There is no treatment for tardive dyskinesia, but||
2280|027|W|in some cases the symptoms may lessen or stop once metoclopramide||
2280|028|W|is stopped.||
2280|029|B|||
2280|030|U|USES:  Metoclopramide is used by diabetic patients who have poor||
2280|031|U|emptying of their stomachs (gastroparesis). Treating||
2280|032|U|gastroparesis can decrease symptoms of nausea, vomiting, and||
2280|033|U|stomach/abdominal fullness. Metoclopramide works by blocking a||
2280|034|U|natural substance (dopamine). It speeds up stomach emptying and||
2280|035|U|movement of the upper intestines.||
2280|036|U|   This drug is not recommended for use in children due to an||
2280|037|U|increased risk of serious side effects (such as muscle||
2280|038|U|spasms/uncontrolled muscle movements). Ask the doctor or||
2280|039|U|pharmacist for details.||
2280|040|B|||
2280|041|H|HOW TO USE:  See also Warning section.||
2280|042|H|   Read the Medication Guide and Instructions for Use provided by||
2280|043|H|your pharmacist before you start using metoclopramide and each||
2280|044|H|time you get a refill. If you have any questions, ask your doctor||
2280|045|H|or pharmacist.||
2280|046|H|   Use this medication in the nose as directed by your doctor,||
2280|047|H|usually 1 spray in one nostril up to 4 times daily (30 minutes||
2280|048|H|before meals and at bedtime). It is usually used for 2 to 8 weeks||
2280|049|H|until your gut is working well. Follow the instructions to||
2280|050|H|properly prime the spray if you are using the spray for the first||
2280|051|H|time or if you have not used it for 2 weeks or more. When priming||
2280|052|H|the spray, make sure to spray away from your face so that the||
2280|053|H|medication does not get into your eyes.||
2280|054|H|   To use the spray, remove the protective cap and safety clip.||
2280|055|H|Tilt your head slightly forward and carefully insert the tip of||
2280|056|H|the spray nozzle into a nostril. Make sure to point the tip away||
2280|057|H|from the center of your nose. Close the other nostril with the||
2280|058|H|other index finger and then press down on the bottle to spray the||
2280|059|H|medicine into your nostril. Breathe in gently through the open||
2280|060|H|nostril and breathe out slowly through your mouth. Clean the||
2280|061|H|nozzle with a clean tissue and replace the cap and safety clip.||
2280|062|H|   If you are unsure if you received the full dose of the||
2280|063|H|medication, do not repeat the dose. Use the next dose at the||
2280|064|H|regularly scheduled time.||
2280|065|H|   Because of the risk of tardive dyskinesia, do not use this||
2280|066|H|drug more often, in larger doses, or for longer than directed by||
2280|067|H|your doctor.||
2280|068|H|   If directed, use this medication regularly to get the most||
2280|069|H|benefit from it. To help you remember, use it at the same times||
2280|070|H|each day.||
2280|071|H|   If you suddenly stop using this medication, you may have||
2280|072|H|withdrawal symptoms (such as dizziness, nervousness, headaches).||
2280|073|H|To help prevent withdrawal, your doctor may lower your dose||
2280|074|H|slowly. Withdrawal is more likely if you have used metoclopramide||
2280|075|H|for a long time or in high doses. Tell your doctor or pharmacist||
2280|076|H|right away if you have withdrawal.||
2280|077|H|   Tell your doctor if your condition lasts or gets worse.||
2280|078|B|||
2280|079|S|SIDE EFFECTS:  See also Warning section.||
2280|080|S|   Drowsiness, dizziness, tiredness, trouble sleeping, headache,||
2280|081|S|changes in taste, or diarrhea may occur. If any of these effects||
2280|082|S|last or get worse, tell your doctor or pharmacist promptly.||
2280|083|S|   Remember that this medication has been prescribed because your||
2280|084|S|doctor has judged that the benefit to you is greater than the||
2280|085|S|risk of side effects. Many people using this medication do not||
2280|086|S|have serious side effects.||
2280|087|S|   This medication may raise your blood pressure. Check your||
2280|088|S|blood pressure regularly and tell your doctor if the results are||
2280|089|S|high.||
2280|090|S|   Tell your doctor right away if you have any serious side||
2280|091|S|effects, including: mental/mood changes (such as agitation,||
2280|092|S|confusion, depression, thoughts of suicide), inability to keep||
2280|093|S|still/need to pace, muscle spasms/uncontrolled muscle movements||
2280|094|S|(such as twisting neck, arching back), Parkinson-like symptoms||
2280|095|S|(such as shaking, slowed/difficult movement, mask-like facial||
2280|096|S|expression), swelling of the hands/feet, decreased sexual||
2280|097|S|ability, abnormal breast-milk production, enlarged/tender||
2280|098|S|breasts, changes in menstruation in women.||
2280|099|S|   This medication may rarely cause a very serious condition||
2280|100|S|called neuroleptic malignant syndrome (NMS). Get medical help||
2280|101|S|right away if you have any of the following symptoms: fever,||
2280|102|S|muscle stiffness, severe confusion, sweating, fast/irregular||
2280|103|S|heartbeat.||
2280|104|S|   A very serious allergic reaction to this drug is rare.||
2280|105|S|However, get medical help right away if you notice any symptoms||
2280|106|S|of a serious allergic reaction, including: rash, itching/swelling||
2280|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2280|108|S|breathing.||
2280|109|S|   This is not a complete list of possible side effects. If you||
2280|110|S|notice other effects not listed above, contact your doctor or||
2280|111|S|pharmacist.||
2280|112|S|   In the US -||
2280|113|S|   Call your doctor for medical advice about side effects. You||
2280|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2280|115|S|www.fda.gov/medwatch.||
2280|116|S|   In Canada - Call your doctor for medical advice about side||
2280|117|S|effects. You may report side effects to Health Canada at||
2280|118|S|1-866-234-2345.||
2280|119|B|||
2280|120|P|PRECAUTIONS:  Before using metoclopramide, tell your doctor or||
2280|121|P|pharmacist if you are allergic to it; or if you have any other||
2280|122|P|allergies. This product may contain inactive ingredients, which||
2280|123|P|can cause allergic reactions or other problems. Talk to your||
2280|124|P|pharmacist for more details.||
2280|125|P|   Before using this medication, tell your doctor or pharmacist||
2280|126|P|your medical history, especially of: history of movement/muscle||
2280|127|P|disorders (such as tardive dyskinesia, dystonia) caused by a||
2280|128|P|medication, bleeding/blockage/hole in the intestines/stomach,||
2280|129|P|breast cancer, high blood pressure, kidney problems, heart||
2280|130|P|failure, mental/mood problems (such as depression, thoughts of||
2280|131|P|suicide), Parkinson's disease, liver problems (such as cirrhosis,||
2280|132|P|porphyria), a certain adrenal gland tumor (pheochromocytoma),||
2280|133|P|seizures, a certain blood enzyme problem (NADH-cytochrome b5||
2280|134|P|reductase deficiency).||
2280|135|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2280|136|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2280|137|P|machinery, or do anything that needs alertness until you can do||
2280|138|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2280|139|P|are using marijuana (cannabis).||
2280|140|P|   Before having surgery, tell your doctor or dentist about all||
2280|141|P|the products you use (including prescription drugs,||
2280|142|P|nonprescription drugs, and herbal products).||
2280|143|P|   This product may make it harder to control your blood sugar.||
2280|144|P|Check your blood sugar regularly as directed and share the||
2280|145|P|results with your doctor. Tell your doctor right away if you have||
2280|146|P|symptoms of high or low blood sugar. Your doctor may need to||
2280|147|P|adjust your diabetes medication, exercise program, or diet.||
2280|148|P|   Children may be more sensitive to the side effects of this||
2280|149|P|drug, especially muscle spasms/uncontrolled muscle movements. See||
2280|150|P|also Uses section.||
2280|151|P|   Older adults may be more sensitive to the effects of this||
2280|152|P|drug, especially drowsiness, tardive dyskinesia, and Parkinson's||
2280|153|P|type muscle problems. Drowsiness can increase the risk of||
2280|154|P|falling. Since the dose of the nasal spray cannot be adjusted,||
2280|155|P|this form of metoclopramide is not recommended as initial||
2280|156|P|treatment in older adults.||
2280|157|P|   During pregnancy, this medication should be used only when||
2280|158|P|clearly needed. Discuss the risks and benefits with your doctor.||
2280|159|P|   This drug passes into breast milk and may have undesirable||
2280|160|P|effects on a nursing infant. Consult your doctor before||
2280|161|P|breastfeeding.||
2280|162|B|||
2280|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2280|164|I|medications work or increase your risk for serious side effects.||
2280|165|I|This document does not contain all possible drug interactions.||
2280|166|I|Keep a list of all the products you use (including||
2280|167|I|prescription/nonprescription drugs and herbal products) and share||
2280|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
2280|169|I|the dosage of any medicines without your doctor's approval.||
2280|170|I|   Some products that may interact with this drug are:||
2280|171|I|antipsychotic drugs (such as aripiprazole, haloperidol),||
2280|172|I|atovaquone, dopamine agonists (such as cabergoline, pergolide,||
2280|173|I|ropinirole), fosfomycin, MAO inhibitors (isocarboxazid,||
2280|174|I|linezolid, metaxalone, methylene blue, moclobemide, phenelzine,||
2280|175|I|procarbazine, rasagiline, safinamide, selegiline,||
2280|176|I|tranylcypromine), pramlintide, phenothiazines (such as||
2280|177|I|promethazine, prochlorperazine), rivastigmine.||
2280|178|I|   Other medications can affect the removal of metoclopramide||
2280|179|I|from your body, which may affect how metoclopramide works.||
2280|180|I|Examples include bupropion, fluoxetine, paroxetine, quinidine,||
2280|181|I|among others.||
2280|182|I|   Metoclopramide causes food and medication to move through your||
2280|183|I|stomach more quickly, which may affect the absorption of some||
2280|184|I|drugs. Talk to your doctor or pharmacist to see if any of the||
2280|185|I|drugs that you are taking may be affected.||
2280|186|I|   Tell your doctor or pharmacist if you are using other products||
2280|187|I|that cause drowsiness such as opioid pain or cough relievers||
2280|188|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2280|189|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2280|190|I|zolpidem), muscle relaxants (such as carisoprodol,||
2280|191|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2280|192|I|diphenhydramine).||
2280|193|I|   Check the labels on all your medicines (such as allergy or||
2280|194|I|cough-and-cold products) because they may contain ingredients||
2280|195|I|that cause drowsiness. Ask your pharmacist about using those||
2280|196|I|products safely.||
2280|197|B|||
2280|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2280|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2280|200|O|poison control center right away. US residents can call||
2280|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2280|202|B|||
2280|203|N|NOTES:  Do not share this medication with others.||
2280|204|B|||
2280|205|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
2280|206|D|next dose at the regular time. Do not double the dose to catch||
2280|207|D|up.||
2280|208|B|||
2280|209|R|STORAGE:  Store at room temperature. Once the bottle is opened,||
2280|210|R|this medication expires after 4 weeks. Keep all medications away||
2280|211|R|from children and pets.||
2280|212|R|   Do not flush medications down the toilet or pour them into a||
2280|213|R|drain unless instructed to do so. Properly discard this product||
2280|214|R|when it is expired or no longer needed. Consult your pharmacist||
2280|215|R|or local waste disposal company.||
2280|216|B|||
2280|217|A|Information last revised September 2024.||
2280|218|A|Copyright(c) 2025 First Databank, Inc.||
2280|219|B|||
2282|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2282|002|Z|does NOT have all possible information about this product. This||
2282|003|Z|information does not assure that this product is safe, effective,||
2282|004|Z|or appropriate for you. This information is not individual||
2282|005|Z|medical advice and does not substitute for the advice of your||
2282|006|Z|health care professional. Always ask your health care||
2282|007|Z|professional for complete information about this product and your||
2282|008|Z|specific health needs.||
2282|009|B|||
2282|010|T|FEXOFENADINE/PSEUDOEPHEDRINE EXTENDED-RELEASE - ORAL||
2282|011|F|(fex-oh-FEN-uh-deen/sue-doh-eff-ED-rin)||
2282|012|B|||
2282|013|C|COMMON BRAND NAME(S): Allegra D||
2282|014|B|||
2282|015|U|USES:  This combination medication is used to temporarily relieve||
2282|016|U|symptoms caused by the common cold, flu, or allergies. It||
2282|017|U|contains 2 medications: fexofenadine and pseudoephedrine.||
2282|018|U|Fexofenadine is an antihistamine that helps relieve watery eyes,||
2282|019|U|itchy eyes/nose/throat, runny nose, and sneezing. Pseudoephedrine||
2282|020|U|is a decongestant that helps relieve stuffy nose and ear||
2282|021|U|congestion symptoms.||
2282|022|U|   This medication is not recommended for use in children under||
2282|023|U|12 years of age due to the large amount of pseudoephedrine in it.||
2282|024|B|||
2282|025|H|HOW TO USE:  If you are taking the over-the-counter product to||
2282|026|H|self-treat, read all directions on the product package before||
2282|027|H|taking this medication. If you have any questions, consult your||
2282|028|H|pharmacist. If your doctor has prescribed this medication, take||
2282|029|H|it as directed.||
2282|030|H|   Take this medication by mouth on an empty stomach (at least 1||
2282|031|H|hour before or 2 hours after a meal). Take this medication with||
2282|032|H|water. Do not take with fruit juices (such as apple, grapefruit,||
2282|033|H|or orange) since they may decrease the absorption of this drug.||
2282|034|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
2282|035|H|Doing so can release all of the drug at once, increasing the risk||
2282|036|H|of side effects.||
2282|037|H|   The dosage is based on your medical condition and response to||
2282|038|H|treatment. Do not increase your dose or take this medication more||
2282|039|H|often than directed.||
2282|040|H|   Do not take antacids containing aluminum and magnesium within||
2282|041|H|2 hours of taking this medication. These antacids can decrease||
2282|042|H|the absorption of fexofenadine.||
2282|043|H|   Tell your doctor if your symptoms do not get better after 1||
2282|044|H|week, if they get worse, or if they occur with a fever.||
2282|045|B|||
2282|046|S|SIDE EFFECTS:  Dizziness, trouble sleeping, nausea, or headache||
2282|047|S|may occur. If any of these effects last or get worse, tell your||
2282|048|S|doctor or pharmacist promptly.||
2282|049|S|   An empty tablet shell may appear in your stool. This effect is||
2282|050|S|harmless because your body has already absorbed the medication.||
2282|051|S|   If your doctor has prescribed this medication, remember that||
2282|052|S|your doctor has judged that the benefit to you is greater than||
2282|053|S|the risk of side effects. Many people using this medication do||
2282|054|S|not have serious side effects.||
2282|055|S|   This medication may raise your blood pressure. Check your||
2282|056|S|blood pressure regularly and tell your doctor if the results are||
2282|057|S|high.||
2282|058|S|   Tell your doctor right away if you have any serious side||
2282|059|S|effects, including: fast/irregular/pounding heartbeat, shaking||
2282|060|S|(tremor), mental/mood changes (such as anxiety, confusion,||
2282|061|S|nervousness, restlessness), problems urinating.||
2282|062|S|   Get medical help right away if you have any very serious side||
2282|063|S|effects, including: seizures.||
2282|064|S|   A very serious allergic reaction to this drug is rare.||
2282|065|S|However, get medical help right away if you notice any symptoms||
2282|066|S|of a serious allergic reaction, including: rash, itching/swelling||
2282|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2282|068|S|breathing.||
2282|069|S|   This is not a complete list of possible side effects. If you||
2282|070|S|notice other effects not listed above, contact your doctor or||
2282|071|S|pharmacist.||
2282|072|S|   In the US -||
2282|073|S|   Call your doctor for medical advice about side effects. You||
2282|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2282|075|S|www.fda.gov/medwatch.||
2282|076|S|   In Canada - Call your doctor for medical advice about side||
2282|077|S|effects. You may report side effects to Health Canada at||
2282|078|S|1-866-234-2345.||
2282|079|B|||
2282|080|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2282|081|P|pharmacist if you are allergic to fexofenadine or||
2282|082|P|pseudoephedrine; or if you have any other allergies. Also, tell||
2282|083|P|your doctor if you have had serious side effects from similar||
2282|084|P|medications (such as other decongestants, including||
2282|085|P|phenylephrine). This product may contain inactive ingredients,||
2282|086|P|which can cause allergic reactions or other problems. Talk to||
2282|087|P|your pharmacist for more details.||
2282|088|P|   Before using this medication, tell your doctor or pharmacist||
2282|089|P|your medical history, especially of: glaucoma, difficulty||
2282|090|P|urinating (such as due to an enlarged prostate), high blood||
2282|091|P|pressure (hypertension), heart/blood vessel disease (such as||
2282|092|P|coronary artery disease), overactive thyroid (hyperthyroidism),||
2282|093|P|diabetes, kidney disease.||
2282|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2282|095|P|can make you more dizzy. Do not drive, use machinery, or do||
2282|096|P|anything that needs alertness until you can do it safely. Limit||
2282|097|P|alcoholic beverages. Talk to your doctor if you are using||
2282|098|P|marijuana (cannabis).||
2282|099|P|   Before having surgery, tell your doctor or dentist about all||
2282|100|P|the products you use (including prescription drugs,||
2282|101|P|nonprescription drugs, and herbal products).||
2282|102|P|   Older adults may be more sensitive to the side effects of this||
2282|103|P|drug, especially fast/irregular heartbeat, dizziness, problems||
2282|104|P|urinating, trouble sleeping, or confusion.||
2282|105|P|   During pregnancy, this medication should be used only when||
2282|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
2282|107|P|   This medication passes into breast milk. Consult your doctor||
2282|108|P|before breastfeeding.||
2282|109|B|||
2282|110|I|DRUG INTERACTIONS:  See also How to Use section.||
2282|111|I|   Drug interactions may change how your medications work or||
2282|112|I|increase your risk for serious side effects. This document does||
2282|113|I|not contain all possible drug interactions. Keep a list of all||
2282|114|I|the products you use (including prescription/nonprescription||
2282|115|I|drugs and herbal products) and share it with your doctor and||
2282|116|I|pharmacist. Do not start, stop, or change the dosage of any||
2282|117|I|medicines without your doctor's approval.||
2282|118|I|   Taking MAO inhibitors with this medication may cause a serious||
2282|119|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2282|120|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2282|121|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2282|122|I|selegiline, tranylcypromine) during treatment with this||
2282|123|I|medication. Most MAO inhibitors should also not be taken for two||
2282|124|I|weeks before treatment with this medication. Ask your doctor when||
2282|125|I|to start or stop taking this medication.||
2282|126|I|   Check the labels on all your medicines (such as cough-and-cold||
2282|127|I|products) because they may contain similar ingredients||
2282|128|I|(decongestants such as phenylephrine). Ask your pharmacist about||
2282|129|I|using those products safely.||
2282|130|I|   This medication may interfere with certain lab tests (such as||
2282|131|I|allergy skin testing), possibly causing false test results. Make||
2282|132|I|sure lab personnel and all your doctors know you use this drug.||
2282|133|B|||
2282|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2282|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2282|136|O|poison control center right away. US residents can call||
2282|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2282|138|O|Symptoms of overdose may include: fast/irregular heartbeat,||
2282|139|O|mental/mood changes (such as anxiety, restlessness), seizures.||
2282|140|B|||
2282|141|N|NOTES:  Keep all medical and lab appointments.||
2282|142|B|||
2282|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2282|144|D|remember. If it is near the time of the next dose, skip the||
2282|145|D|missed dose. Take your next dose at the regular time. Do not||
2282|146|D|double the dose to catch up.||
2282|147|B|||
2282|148|R|STORAGE:  Store at room temperature away from light and moisture.||
2282|149|R|Do not store in the bathroom. Different brands of this medication||
2282|150|R|may have different storage needs. Check the product package for||
2282|151|R|instructions on how to store your brand, or ask your pharmacist.||
2282|152|R|Keep all medications away from children and pets.||
2282|153|R|   Do not flush medications down the toilet or pour them into a||
2282|154|R|drain unless instructed to do so. Properly discard this product||
2282|155|R|when it is expired or no longer needed. Consult your pharmacist||
2282|156|R|or local waste disposal company.||
2282|157|B|||
2282|158|A|Information last revised July 2025.||
2282|159|A|Copyright(c) 2025 First Databank, Inc.||
2282|160|B|||
2284|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2284|002|Z|does NOT have all possible information about this product. This||
2284|003|Z|information does not assure that this product is safe, effective,||
2284|004|Z|or appropriate for you. This information is not individual||
2284|005|Z|medical advice and does not substitute for the advice of your||
2284|006|Z|health care professional. Always ask your health care||
2284|007|Z|professional for complete information about this product and your||
2284|008|Z|specific health needs.||
2284|009|B|||
2284|010|T|FLUVASTATIN EXTENDED-RELEASE - ORAL||
2284|011|F|(FLEW-vuh-stat-in)||
2284|012|B|||
2284|013|C|COMMON BRAND NAME(S): Lescol XL||
2284|014|B|||
2284|015|U|USES:  Fluvastatin is used along with a proper diet to help lower||
2284|016|U|"bad" cholesterol and fats (such as LDL, triglycerides) and raise||
2284|017|U|"good" cholesterol (HDL) in the blood. It belongs to a group of||
2284|018|U|drugs known as "statins." It works by reducing the amount of||
2284|019|U|cholesterol made by the liver. Lowering "bad" cholesterol and||
2284|020|U|triglycerides and raising "good" cholesterol decreases the risk||
2284|021|U|of heart disease and helps prevent strokes and heart attacks.||
2284|022|U|   In addition to eating a proper diet (such as a||
2284|023|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
2284|024|U|help this medication work better include exercising, losing||
2284|025|U|weight if overweight, and stopping smoking. Consult your doctor||
2284|026|U|for more details.||
2284|027|B|||
2284|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2284|029|H|from your pharmacist before you start taking fluvastatin and each||
2284|030|H|time you get a refill. If you have any questions, ask your doctor||
2284|031|H|or pharmacist.||
2284|032|H|   Take this medication by mouth with or without food as directed||
2284|033|H|by your doctor, usually once daily.||
2284|034|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
2284|035|H|Doing so can release all of the drug at once, increasing the risk||
2284|036|H|of side effects.||
2284|037|H|   Dosage is based on your medical condition, response to||
2284|038|H|treatment, age, and other medications you may be taking. Be sure||
2284|039|H|to tell your doctor and pharmacist about all the products you use||
2284|040|H|(including prescription drugs, nonprescription drugs, and herbal||
2284|041|H|products).||
2284|042|H|   If you also take certain other drugs to lower your cholesterol||
2284|043|H|(bile acid-binding resins such as cholestyramine or colestipol),||
2284|044|H|take fluvastatin at least 1 hour before or at least 4 hours after||
2284|045|H|taking these medications. These products can react with||
2284|046|H|fluvastatin, preventing its full absorption.||
2284|047|H|   Take this medication regularly in order to get the most||
2284|048|H|benefit from it. Remember to take it at the same time each day.||
2284|049|H|Keep taking this medication even if you feel well. Most people||
2284|050|H|with high cholesterol or triglycerides do not feel sick.||
2284|051|H|   It is very important to continue to follow your doctor's||
2284|052|H|advice about diet and exercise. It may take up to 4 weeks before||
2284|053|H|you get the full benefit of this drug.||
2284|054|B|||
2284|055|S|SIDE EFFECTS:  Stomach upset may occur. If this effect lasts or||
2284|056|S|gets worse, tell your doctor or pharmacist promptly.||
2284|057|S|   Remember that this medication has been prescribed because your||
2284|058|S|doctor has judged that the benefit to you is greater than the||
2284|059|S|risk of side effects. Many people using this medication do not||
2284|060|S|have serious side effects.||
2284|061|S|   A very small number of people taking fluvastatin may have mild||
2284|062|S|memory problems or confusion. If these rare effects occur, talk||
2284|063|S|to your doctor.||
2284|064|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
2284|065|S|doctor about the benefits and risks.||
2284|066|S|   This drug may rarely cause muscle problems (which can rarely||
2284|067|S|lead to very serious conditions called rhabdomyolysis and||
2284|068|S|autoimmune myopathy). Tell your doctor right away if you develop||
2284|069|S|any of these symptoms during treatment and if these symptoms last||
2284|070|S|after your doctor stops this drug: muscle||
2284|071|S|pain/tenderness/weakness (especially with fever or unusual||
2284|072|S|tiredness), signs of kidney problems (such as change in the||
2284|073|S|amount of urine).||
2284|074|S|   This medication may rarely cause liver problems. Tell your||
2284|075|S|doctor right away if you develop symptoms of liver problems,||
2284|076|S|including: nausea/vomiting that doesn't stop, yellowing||
2284|077|S|eyes/skin, dark urine, stomach/abdominal pain.||
2284|078|S|   A very serious allergic reaction to this drug is rare.||
2284|079|S|However, get medical help right away if you notice any symptoms||
2284|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2284|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2284|082|S|breathing.||
2284|083|S|   This is not a complete list of possible side effects. If you||
2284|084|S|notice other effects not listed above, contact your doctor or||
2284|085|S|pharmacist.||
2284|086|S|   In the US -||
2284|087|S|   Call your doctor for medical advice about side effects. You||
2284|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2284|089|S|www.fda.gov/medwatch.||
2284|090|S|   In Canada - Call your doctor for medical advice about side||
2284|091|S|effects. You may report side effects to Health Canada at||
2284|092|S|1-866-234-2345.||
2284|093|B|||
2284|094|P|PRECAUTIONS:  Before taking fluvastatin, tell your doctor or||
2284|095|P|pharmacist if you are allergic to it; or if you have any other||
2284|096|P|allergies. This product may contain inactive ingredients, which||
2284|097|P|can cause allergic reactions or other problems. Talk to your||
2284|098|P|pharmacist for more details.||
2284|099|P|   Before using this medication, tell your doctor or pharmacist||
2284|100|P|your medical history, especially of: liver disease, kidney||
2284|101|P|disease, alcohol use.||
2284|102|P|   Before having surgery, tell your doctor or dentist about all||
2284|103|P|the products you use (including prescription drugs,||
2284|104|P|nonprescription drugs, and herbal products).||
2284|105|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
2284|106|P|your risk for liver problems, especially when combined with||
2284|107|P|fluvastatin. Ask your doctor or pharmacist for more information.||
2284|108|P|   Older adults may be more sensitive to the side effects of the||
2284|109|P|drug, especially muscle problems.||
2284|110|P|   During pregnancy, this medication should be used only when||
2284|111|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2284|112|P|benefits with your doctor.||
2284|113|P|   It is unknown if this medication passes into breast milk.||
2284|114|P|Because of the possible risk to the infant, breastfeeding is not||
2284|115|P|recommended while using this medication. Consult your doctor||
2284|116|P|before breastfeeding.||
2284|117|B|||
2284|118|I|DRUG INTERACTIONS:  See also How to Use section.||
2284|119|I|   Drug interactions may change how your medications work or||
2284|120|I|increase your risk for serious side effects. This document does||
2284|121|I|not contain all possible drug interactions. Keep a list of all||
2284|122|I|the products you use (including prescription/nonprescription||
2284|123|I|drugs and herbal products) and share it with your doctor and||
2284|124|I|pharmacist. Do not start, stop, or change the dosage of any||
2284|125|I|medicines without your doctor's approval.||
2284|126|I|   Some products that may interact with this drug include:||
2284|127|I|colchicine, daptomycin, gemfibrozil, phenytoin.||
2284|128|I|   Do not take any red yeast rice products while you are taking||
2284|129|I|fluvastatin because some red yeast rice products may also contain||
2284|130|I|a statin called lovastatin. Taking fluvastatin and red yeast rice||
2284|131|I|products together can increase your risk of serious muscle and||
2284|132|I|liver problems.||
2284|133|B|||
2284|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2284|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2284|136|O|poison control center right away. US residents can call||
2284|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2284|138|B|||
2284|139|N|NOTES:  Do not share this medication with others.||
2284|140|N|   Lab and/or medical tests (such as blood||
2284|141|N|cholesterol/triglyceride levels, liver function) should be done||
2284|142|N|while you are taking this medication. Keep all medical and lab||
2284|143|N|appointments. Consult your doctor for more details.||
2284|144|B|||
2284|145|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2284|146|D|If it is near the time of the next dose, skip the missed dose.||
2284|147|D|Use your next dose at the regular time. Do not double the dose to||
2284|148|D|catch up.||
2284|149|B|||
2284|150|R|STORAGE:  Store at room temperature away from light and moisture.||
2284|151|R|Do not store in the bathroom. Keep all medications away from||
2284|152|R|children and pets.||
2284|153|R|   Do not flush medications down the toilet or pour them into a||
2284|154|R|drain unless instructed to do so. Properly discard this product||
2284|155|R|when it is expired or no longer needed. Consult your pharmacist||
2284|156|R|or local waste disposal company.||
2284|157|B|||
2284|158|A|Information last revised May 2024.||
2284|159|A|Copyright(c) 2025 First Databank, Inc.||
2284|160|B|||
2285|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2285|002|Z|does NOT have all possible information about this product. This||
2285|003|Z|information does not assure that this product is safe, effective,||
2285|004|Z|or appropriate for you. This information is not individual||
2285|005|Z|medical advice and does not substitute for the advice of your||
2285|006|Z|health care professional. Always ask your health care||
2285|007|Z|professional for complete information about this product and your||
2285|008|Z|specific health needs.||
2285|009|B|||
2285|010|T|AZACITIDINE - ORAL||
2285|011|F|(AY-za-SYE-ti-deen)||
2285|012|B|||
2285|013|C|COMMON BRAND NAME(S): Onureg||
2285|014|B|||
2285|015|U|USES:  This medication is used to treat a certain type of cancer||
2285|016|U|(acute myeloid leukemia). Azacitidine is a chemotherapy drug that||
2285|017|U|works by slowing or stopping the growth of cancer cells.||
2285|018|U|   This form of azacitidine should not be used in place of the||
2285|019|U|form given by injection.||
2285|020|B|||
2285|021|H|HOW TO USE:  Take this medication by mouth with or without food||
2285|022|H|as directed by your doctor, usually once a day on days 1 through||
2285|023|H|14 of each 28-day treatment cycle. Swallow the tablets whole. Do||
2285|024|H|not cut, crush, or chew the tablets. The dosage is based on your||
2285|025|H|medical condition and response to treatment.||
2285|026|H|   To decrease the risk of nausea and vomiting, your doctor may||
2285|027|H|prescribe other medication(s) for you to take 30 minutes before||
2285|028|H|each dose. If you do not have nausea and vomiting after the first||
2285|029|H|2 cycles, your doctor may direct you to not take the other||
2285|030|H|medication(s). Carefully follow your doctor's directions for all||
2285|031|H|your medications.||
2285|032|H|   If you vomit after taking a dose, do not take another dose.||
2285|033|H|Take your next dose at the regular time.||
2285|034|H|   Take this medication regularly to get the most benefit from||
2285|035|H|it. To help you remember, use it at the same time on days 1||
2285|036|H|through 14 of your treatment cycle.||
2285|037|H|   Do not increase your dose or use this drug more often or for||
2285|038|H|longer than prescribed. Your condition will not improve any||
2285|039|H|faster, and your risk of serious side effects will increase.||
2285|040|H|   Since this drug can be absorbed through the skin and lungs and||
2285|041|H|may harm an unborn baby, women who are pregnant or who may become||
2285|042|H|pregnant should not handle this medication or breathe the dust||
2285|043|H|from the tablets.||
2285|044|B|||
2285|045|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea or constipation,||
2285|046|S|tiredness, dizziness, muscle/joint pain, or loss of appetite may||
2285|047|S|occur. If any of these effects last or get worse, tell your||
2285|048|S|doctor or pharmacist promptly.||
2285|049|S|   People using this medication may have serious side effects.||
2285|050|S|However, you have been prescribed this drug because your doctor||
2285|051|S|has judged that the benefit to you is greater than the risk of||
2285|052|S|side effects. Careful monitoring by your doctor may decrease your||
2285|053|S|risk.||
2285|054|S|   Tell your doctor right away if you have any serious side||
2285|055|S|effects, including: easy bleeding/bruising.||
2285|056|S|   This medication may lower your ability to fight infections.||
2285|057|S|This may make you more likely to get a serious (rarely fatal)||
2285|058|S|infection or make any infection you have worse. Tell your doctor||
2285|059|S|right away if you have any signs of infection (such as sore||
2285|060|S|throat that doesn't go away, fever, chills).||
2285|061|S|   Azacitidine sometimes causes side effects due to the rapid||
2285|062|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
2285|063|S|risk, your doctor may add a medication and tell you to drink||
2285|064|S|plenty of fluids. Tell your doctor right away if you have||
2285|065|S|symptoms such as: low back/side pain (flank pain), signs of||
2285|066|S|kidney problems (such as painful urination, pink/bloody urine,||
2285|067|S|change in the amount of urine), muscle spasms/weakness.||
2285|068|S|   A very serious allergic reaction to this drug is rare.||
2285|069|S|However, get medical help right away if you notice any symptoms||
2285|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2285|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2285|072|S|breathing.||
2285|073|S|   This is not a complete list of possible side effects. If you||
2285|074|S|notice other effects not listed above, contact your doctor or||
2285|075|S|pharmacist.||
2285|076|S|   In the US -||
2285|077|S|   Call your doctor for medical advice about side effects. You||
2285|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2285|079|S|www.fda.gov/medwatch.||
2285|080|S|   In Canada - Call your doctor for medical advice about side||
2285|081|S|effects. You may report side effects to Health Canada at||
2285|082|S|1-866-234-2345.||
2285|083|B|||
2285|084|P|PRECAUTIONS:  Before using azacitidine, tell your doctor or||
2285|085|P|pharmacist if you are allergic to it; or if you have any other||
2285|086|P|allergies. This product may contain inactive ingredients, which||
2285|087|P|can cause allergic reactions or other problems. Talk to your||
2285|088|P|pharmacist for more details.||
2285|089|P|   Before using this medication, tell your doctor or pharmacist||
2285|090|P|your medical history, especially of: current/recent infection,||
2285|091|P|kidney problems, liver problems.||
2285|092|P|   Azacitidine can make you more likely to get infections or may||
2285|093|P|make current infections worse. Stay away from anyone who has an||
2285|094|P|infection that may easily spread (such as chickenpox, COVID-19,||
2285|095|P|measles, flu). Talk to your doctor if you have been exposed to an||
2285|096|P|infection or for more details.||
2285|097|P|   Tell your health care professional that you are using||
2285|098|P|azacitidine before having any immunizations/vaccinations. Avoid||
2285|099|P|contact with people who have recently received live vaccines||
2285|100|P|(such as flu vaccine inhaled through the nose).||
2285|101|P|   To lower the chance of getting cut, bruised, or injured, use||
2285|102|P|caution with sharp objects like razors and nail cutters, and||
2285|103|P|avoid activities such as contact sports.||
2285|104|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2285|105|P|can make you more dizzy. Do not drive, use machinery, or do||
2285|106|P|anything that needs alertness until you can do it safely. Limit||
2285|107|P|alcoholic beverages. Talk to your doctor if you are using||
2285|108|P|marijuana (cannabis).||
2285|109|P|   Before having surgery, tell your doctor or dentist about all||
2285|110|P|the products you use (including prescription drugs,||
2285|111|P|nonprescription drugs, and herbal products).||
2285|112|P|   Since this drug can be absorbed through the skin and lungs and||
2285|113|P|may harm an unborn baby, women who are pregnant or who may become||
2285|114|P|pregnant should not handle this medication or breathe the dust||
2285|115|P|from the tablets.||
2285|116|P|   Tell your doctor if you are pregnant or plan to become||
2285|117|P|pregnant. You should not become pregnant while using azacitidine.||
2285|118|P|Azacitidine may harm an unborn baby. Your doctor should order a||
2285|119|P|pregnancy test before you start this medication. Women using this||
2285|120|P|medication should ask about reliable forms of birth control||
2285|121|P|during treatment and for 6 months after the last dose. Men using||
2285|122|P|this medication should ask about reliable forms of birth control||
2285|123|P|during treatment and for some time after the last dose. If you or||
2285|124|P|your partner becomes pregnant, talk to your doctor right away||
2285|125|P|about the risks and benefits of this medication.||
2285|126|P|   It is unknown if this drug passes into breast milk. Because of||
2285|127|P|the possible risk to the infant, breastfeeding is not recommended||
2285|128|P|while using this drug and for 1 week after the last dose. Consult||
2285|129|P|your doctor before breastfeeding.||
2285|130|B|||
2285|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2285|132|I|medications work or increase your risk for serious side effects.||
2285|133|I|This document does not contain all possible drug interactions.||
2285|134|I|Keep a list of all the products you use (including||
2285|135|I|prescription/nonprescription drugs and herbal products) and share||
2285|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
2285|137|I|the dosage of any medicines without your doctor's approval.||
2285|138|B|||
2285|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2285|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2285|141|O|poison control center right away. US residents can call||
2285|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2285|143|B|||
2285|144|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2285|145|N|kidney function, liver function) should be done while you are||
2285|146|N|taking this medication. Keep all medical and lab appointments.||
2285|147|B|||
2285|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2285|149|D|remember. If you don't remember until the next day, skip the||
2285|150|D|missed dose. Take your next dose at the regular time. Do not||
2285|151|D|double the dose to catch up.||
2285|152|B|||
2285|153|R|STORAGE:  Store in the original container at room temperature||
2285|154|R|away from light and moisture. Do not store in the bathroom. Keep||
2285|155|R|the drying agent (desiccant) in the bottle. Tightly close the||
2285|156|R|bottle when not in use. Keep all medications away from children||
2285|157|R|and pets.||
2285|158|R|   Do not flush medications down the toilet or pour them into a||
2285|159|R|drain unless instructed to do so. Properly discard this product||
2285|160|R|when it is expired or no longer needed. Consult your pharmacist||
2285|161|R|or local waste disposal company.||
2285|162|B|||
2285|163|M|MEDICAL ALERT:  Your condition can cause complications in a||
2285|164|M|medical emergency. For information about enrolling in MedicAlert,||
2285|165|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2285|166|B|||
2285|167|A|Information last revised April 2025.||
2285|168|A|Copyright(c) 2025 First Databank, Inc.||
2285|169|B|||
2286|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2286|002|Z|does NOT have all possible information about this product. This||
2286|003|Z|information does not assure that this product is safe, effective,||
2286|004|Z|or appropriate for you. This information is not individual||
2286|005|Z|medical advice and does not substitute for the advice of your||
2286|006|Z|health care professional. Always ask your health care||
2286|007|Z|professional for complete information about this product and your||
2286|008|Z|specific health needs.||
2286|009|B|||
2286|010|T|PRALSETINIB - ORAL||
2286|011|F|(pral-SE-ti-nib)||
2286|012|B|||
2286|013|C|COMMON BRAND NAME(S): Gavreto||
2286|014|B|||
2286|015|U|USES:  This medication is used to treat certain types of cancer||
2286|016|U|(lung and thyroid). Pralsetinib belongs to a class of drugs known||
2286|017|U|as kinase inhibitors. It works by slowing or stopping the growth||
2286|018|U|of cancer cells.||
2286|019|B|||
2286|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2286|021|H|from your pharmacist before you start using pralsetinib and each||
2286|022|H|time you get a refill. If you have any questions, ask your doctor||
2286|023|H|or pharmacist.||
2286|024|H|   Take this medication by mouth on an empty stomach as directed||
2286|025|H|by your doctor, usually once daily. Do not eat food for at least||
2286|026|H|2 hours before and at least 1 hour after taking pralsetinib.||
2286|027|H|   The dosage is based on your medical condition, response to||
2286|028|H|treatment, and other medications you may be taking. Be sure to||
2286|029|H|tell your doctor and pharmacist about all the products you use||
2286|030|H|(including prescription drugs, nonprescription drugs, and herbal||
2286|031|H|products). If you have certain side effects, your doctor may||
2286|032|H|adjust your dose or stop treatment for some time.||
2286|033|H|   Do not increase your dose or use this drug more often or for||
2286|034|H|longer than prescribed. Your condition will not improve any||
2286|035|H|faster, and your risk of serious side effects will increase.||
2286|036|H|   Take this medication regularly to get the most benefit from||
2286|037|H|it. To help you remember, take it at the same time each day.||
2286|038|H|   If you vomit after taking a dose, do not take another dose.||
2286|039|H|Take your next dose at your regular time the next day.||
2286|040|H|   Since this drug can be absorbed through the skin and lungs and||
2286|041|H|may harm an unborn baby, women who are pregnant or who may become||
2286|042|H|pregnant should not handle this medication or breathe the dust||
2286|043|H|from the capsules.||
2286|044|B|||
2286|045|S|SIDE EFFECTS:  Tiredness, constipation or diarrhea, muscle/joint||
2286|046|S|pain, fever, or swelling in the hands/legs/face may occur. If any||
2286|047|S|of these effects last or get worse, tell your doctor or||
2286|048|S|pharmacist promptly.||
2286|049|S|   People using this medication may have serious side effects.||
2286|050|S|However, you have been prescribed this drug because your doctor||
2286|051|S|has judged that the benefit to you is greater than the risk of||
2286|052|S|side effects. Careful monitoring by your doctor may decrease your||
2286|053|S|risk.||
2286|054|S|   This medication may raise your blood pressure. Check your||
2286|055|S|blood pressure regularly and tell your doctor if the results are||
2286|056|S|high. Your doctor may control your blood pressure with||
2286|057|S|medication.||
2286|058|S|   Tell your doctor right away if you have any serious side||
2286|059|S|effects, including: easy bruising/bleeding, slow wound healing,||
2286|060|S|new or worsening lung problems (such as shortness of breath,||
2286|061|S|cough), signs of liver problems (such as nausea/vomiting that||
2286|062|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
2286|063|S|eyes/skin, dark urine).||
2286|064|S|   Pralsetinib sometimes causes side effects due to the rapid||
2286|065|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
2286|066|S|risk, your doctor may add a medication and tell you to drink||
2286|067|S|plenty of fluids. Tell your doctor right away if you have||
2286|068|S|symptoms such as: low back/side pain (flank pain), signs of||
2286|069|S|kidney problems (such as painful urination, pink/bloody urine,||
2286|070|S|change in the amount of urine), muscle spasms/weakness.||
2286|071|S|   A very serious allergic reaction to this drug is rare.||
2286|072|S|However, get medical help right away if you notice any symptoms||
2286|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2286|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2286|075|S|breathing.||
2286|076|S|   This is not a complete list of possible side effects. If you||
2286|077|S|notice other effects not listed above, contact your doctor or||
2286|078|S|pharmacist.||
2286|079|S|   In the US -||
2286|080|S|   Call your doctor for medical advice about side effects. You||
2286|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2286|082|S|www.fda.gov/medwatch.||
2286|083|S|   In Canada - Call your doctor for medical advice about side||
2286|084|S|effects. You may report side effects to Health Canada at||
2286|085|S|1-866-234-2345.||
2286|086|B|||
2286|087|P|PRECAUTIONS:  Before taking pralsetinib, tell your doctor or||
2286|088|P|pharmacist if you are allergic to it; or if you have any other||
2286|089|P|allergies. This product may contain inactive ingredients, which||
2286|090|P|can cause allergic reactions or other problems. Talk to your||
2286|091|P|pharmacist for more details.||
2286|092|P|   Before using this medication, tell your doctor or pharmacist||
2286|093|P|your medical history, especially of: blood/bleeding problems,||
2286|094|P|high blood pressure, liver problems, lung or breathing problems||
2286|095|P|other than lung cancer.||
2286|096|P|   Before having surgery, tell your doctor or dentist about all||
2286|097|P|the products you use (including prescription drugs,||
2286|098|P|nonprescription drugs, and herbal products).||
2286|099|P|   This medication may cause wounds to heal slowly or poorly.||
2286|100|P|Your doctor or dentist may tell you to temporarily stop treatment||
2286|101|P|with this medication at least 5 days before surgery. Ask your||
2286|102|P|doctor or dentist for specific instructions about when to stop||
2286|103|P|and when to restart treatment with this medication. Tell your||
2286|104|P|doctor/dentist right away if you have wounds that are not healing||
2286|105|P|well.||
2286|106|P|   Since this drug can be absorbed through the skin and lungs and||
2286|107|P|may harm an unborn baby, women who are pregnant or who may become||
2286|108|P|pregnant should not handle this medication or breathe the dust||
2286|109|P|from the tablets.||
2286|110|P|   Tell your doctor if you are pregnant or plan to become||
2286|111|P|pregnant. You should not become pregnant while using pralsetinib.||
2286|112|P|Pralsetinib may harm an unborn baby. Your doctor should order a||
2286|113|P|pregnancy test before you start this medication. Women using this||
2286|114|P|medication should ask about reliable forms of non-hormonal birth||
2286|115|P|control during treatment and for 2 weeks after the last dose. Men||
2286|116|P|using this medication should ask about reliable forms of birth||
2286|117|P|control during treatment and for 1 week after the last dose. If||
2286|118|P|you or your partner becomes pregnant, talk to your doctor right||
2286|119|P|away about the risks and benefits of this medication.||
2286|120|P|   It is unknown if this drug passes into breast milk. Because of||
2286|121|P|the possible risk to the infant, breastfeeding is not recommended||
2286|122|P|while using this drug and for 1 week after the last dose. Consult||
2286|123|P|your doctor before breastfeeding.||
2286|124|B|||
2286|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2286|126|I|medications work or increase your risk for serious side effects.||
2286|127|I|This document does not contain all possible drug interactions.||
2286|128|I|Keep a list of all the products you use (including||
2286|129|I|prescription/nonprescription drugs and herbal products) and share||
2286|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
2286|131|I|the dosage of any medicines without your doctor's approval.||
2286|132|I|   Other medications can affect the removal of pralsetinib from||
2286|133|I|your body, which may affect how pralsetinib works. Examples||
2286|134|I|include azole antifungals (such as itraconazole, ketoconazole),||
2286|135|I|drugs used to treat seizures (such as phenytoin, carbamazepine),||
2286|136|I|St. John's wort, among others.||
2286|137|B|||
2286|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2286|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2286|140|O|poison control center right away. US residents can call||
2286|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2286|142|B|||
2286|143|N|NOTES:  Do not share this medication with others.||
2286|144|N|   Lab and/or medical tests (such as blood mineral levels,||
2286|145|N|kidney/liver function, complete blood counts) should be done||
2286|146|N|before you start taking this medication and while you are taking||
2286|147|N|it. Keep all medical and lab appointments.||
2286|148|B|||
2286|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2286|150|D|remember. If you don't remember until the next day, skip the||
2286|151|D|missed dose. Take your next dose at the regular time. Do not||
2286|152|D|double the dose to catch up.||
2286|153|B|||
2286|154|R|STORAGE:  Store at room temperature away from light and moisture.||
2286|155|R|Do not store in the bathroom. Keep all medications away from||
2286|156|R|children and pets.||
2286|157|R|   Do not flush medications down the toilet or pour them into a||
2286|158|R|drain unless instructed to do so. Properly discard this product||
2286|159|R|when it is expired or no longer needed. Consult your pharmacist||
2286|160|R|or local waste disposal company.||
2286|161|B|||
2286|162|A|Information last revised May 2024.||
2286|163|A|Copyright(c) 2025 First Databank, Inc.||
2286|164|B|||
2288|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2288|002|Z|does NOT have all possible information about this product. This||
2288|003|Z|information does not assure that this product is safe, effective,||
2288|004|Z|or appropriate for you. This information is not individual||
2288|005|Z|medical advice and does not substitute for the advice of your||
2288|006|Z|health care professional. Always ask your health care||
2288|007|Z|professional for complete information about this product and your||
2288|008|Z|specific health needs.||
2288|009|B|||
2288|010|T|VITAMIN B-12/FOLIC ACID/VITAMIN B-6 - ORAL||
2288|011|F|(vitamin B12/FOH-lick/vitamin B6)||
2288|012|B|||
2288|013|C|COMMON BRAND NAME(S): Folgard, Folgard RX 2.2, Foltx,||
2288|014|C|Homocysteine Formula||
2288|015|B|||
2288|016|U|USES:  This combination of vitamins provides vitamin B-6, vitamin||
2288|017|U|B-12 and folic acid to people who do not have enough of these||
2288|018|U|vitamins for good health.||
2288|019|B|||
2288|020|H|HOW TO USE:  Take this medication by mouth with or without food,||
2288|021|H|usually once daily or as directed by your doctor. If stomach||
2288|022|H|upset occurs, it may help to take this product with food.||
2288|023|H|   Use this medication regularly in order to get the most benefit||
2288|024|H|from it. To help you remember, use it at the same time each day.||
2288|025|H|The dosage is based on your medical condition and response to||
2288|026|H|treatment.||
2288|027|B|||
2288|028|S|SIDE EFFECTS:  Nausea, stomach upset, diarrhea, drowsiness,||
2288|029|S|flushing, and numbness/tingling may occur. If any of these||
2288|030|S|effects last or get worse, notify your doctor or pharmacist||
2288|031|S|promptly.||
2288|032|S|   If your doctor has prescribed this medication, remember that||
2288|033|S|your doctor has judged that the benefit to you is greater than||
2288|034|S|the risk of side effects. Many people using this medication do||
2288|035|S|not have serious side effects.||
2288|036|S|   Tell your doctor right away if you have any serious side||
2288|037|S|effects, including: mental/mood changes, unusual weakness.||
2288|038|S|   A very serious allergic reaction to this drug is rare.||
2288|039|S|However, get medical help right away if you notice any symptoms||
2288|040|S|of a serious allergic reaction, including: rash, itching/swelling||
2288|041|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2288|042|S|breathing.||
2288|043|S|   This is not a complete list of possible side effects. If you||
2288|044|S|notice other effects not listed above, contact your doctor or||
2288|045|S|pharmacist.||
2288|046|S|   In the US -||
2288|047|S|   Call your doctor for medical advice about side effects. You||
2288|048|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2288|049|S|www.fda.gov/medwatch.||
2288|050|S|   In Canada - Call your doctor for medical advice about side||
2288|051|S|effects. You may report side effects to Health Canada at||
2288|052|S|1-866-234-2345.||
2288|053|B|||
2288|054|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2288|055|P|pharmacist if you are allergic to it; or if you have any other||
2288|056|P|allergies. This product may contain inactive ingredients, which||
2288|057|P|can cause allergic reactions or other problems. Talk to your||
2288|058|P|pharmacist for more details.||
2288|059|P|   Before taking this medication, tell your doctor or pharmacist||
2288|060|P|your medical history, especially of: certain blood disorders||
2288|061|P|(such as pernicious anemia, other anemias).||
2288|062|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
2288|063|P|can make you more drowsy. Do not drive, use machinery, or do||
2288|064|P|anything that needs alertness until you can do it safely. Limit||
2288|065|P|alcoholic beverages. Talk to your doctor if you are using||
2288|066|P|marijuana (cannabis).||
2288|067|P|   Before having surgery, tell your doctor or dentist about all||
2288|068|P|the products you use (including prescription drugs,||
2288|069|P|nonprescription drugs, and herbal products).||
2288|070|P|   During pregnancy, this medication should be used only when||
2288|071|P|clearly needed. Discuss the risks and benefits with your doctor.||
2288|072|P|   This medication passes into breast milk. Consult your doctor||
2288|073|P|before breastfeeding.||
2288|074|B|||
2288|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2288|076|I|medications work or increase your risk for serious side effects.||
2288|077|I|This document does not contain all possible drug interactions.||
2288|078|I|Keep a list of all the products you use (including||
2288|079|I|prescription/nonprescription drugs and herbal products) and share||
2288|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
2288|081|I|the dosage of any medicines without your doctor's approval.||
2288|082|I|   This product may interfere with certain lab tests (such as||
2288|083|I|intrinsic factor antibodies, certain urobilinogen tests),||
2288|084|I|possibly causing false test results. Make sure lab personnel and||
2288|085|I|all your doctors know you use this product.||
2288|086|B|||
2288|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2288|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2288|089|O|poison control center right away. US residents can call||
2288|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2288|091|B|||
2288|092|N|NOTES:  Do not share this medication with others.||
2288|093|N|   Lab and/or medical tests (such as complete blood count,||
2288|094|N|homocysteine levels) may be done while you are taking this||
2288|095|N|medication. Keep all medical and lab appointments. Consult your||
2288|096|N|doctor for more details.||
2288|097|N|   Remember that it is best to get your vitamins and minerals||
2288|098|N|from healthy foods. Maintain a well-balanced diet and follow any||
2288|099|N|dietary guidelines as directed by your doctor. B vitamins,||
2288|100|N|including folic acid, are naturally found in leafy greens, other||
2288|101|N|vegetables, and citrus fruits. Folic acid is also found in||
2288|102|N|enriched grains such as bread, pasta and cereal.||
2288|103|N|   Some brands of this medication may also contain ingredients||
2288|104|N|such as vitamin E, para-aminobenzoic acid, or alpha-lipoic acid.||
2288|105|N|Consult your doctor or pharmacist if you have questions about the||
2288|106|N|ingredients in your brand.||
2288|107|B|||
2288|108|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2288|109|D|remember. If it is near the time of the next dose, skip the||
2288|110|D|missed dose. Take your next dose at the regular time. Do not||
2288|111|D|double the dose to catch up.||
2288|112|B|||
2288|113|R|STORAGE:  Store at room temperature away from light and moisture.||
2288|114|R|Do not store in the bathroom. Keep all medications away from||
2288|115|R|children and pets.||
2288|116|R|   Do not flush medications down the toilet or pour them into a||
2288|117|R|drain unless instructed to do so. Properly discard this product||
2288|118|R|when it is expired or no longer needed. Consult your pharmacist||
2288|119|R|or local waste disposal company.||
2288|120|B|||
2288|121|A|Information last revised October 2025.||
2288|122|A|Copyright(c) 2025 First Databank, Inc.||
2288|123|B|||
2289|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2289|002|Z|does NOT have all possible information about this product. This||
2289|003|Z|information does not assure that this product is safe, effective,||
2289|004|Z|or appropriate for you. This information is not individual||
2289|005|Z|medical advice and does not substitute for the advice of your||
2289|006|Z|health care professional. Always ask your health care||
2289|007|Z|professional for complete information about this product and your||
2289|008|Z|specific health needs.||
2289|009|B|||
2289|010|T|NAPROXEN SUSPENSION - ORAL||
2289|011|F|(nah-PROX-en)||
2289|012|B|||
2289|013|C|COMMON BRAND NAME(S): Naprosyn||
2289|014|B|||
2289|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
2289|016|W|naproxen) may rarely increase the risk for a heart attack or||
2289|017|W|stroke. This effect can happen at any time while taking this drug||
2289|018|W|but is more likely if you take it for a long time. The risk may||
2289|019|W|be greater in older adults or if you have heart disease or||
2289|020|W|increased risk for heart disease (for example, due to smoking,||
2289|021|W|family history of heart disease, or conditions such as high blood||
2289|022|W|pressure or diabetes). Do not take this drug right before or||
2289|023|W|after heart bypass surgery (CABG).||
2289|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
2289|025|W|from the stomach or intestines. This effect can occur without||
2289|026|W|warning at any time while taking this drug. Older adults may be||
2289|027|W|at higher risk for this effect.||
2289|028|W|   Stop taking naproxen and get medical help right away if you||
2289|029|W|notice any of these rare but serious side effects:||
2289|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
2289|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
2289|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
2289|033|W|side of the body, trouble speaking, sudden vision changes.||
2289|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
2289|035|W|of taking this drug.||
2289|036|B|||
2289|037|U|USES:  Naproxen is used to relieve pain from various conditions||
2289|038|U|such as headaches, muscle aches, tendonitis, dental pain, and||
2289|039|U|menstrual cramps. It also reduces pain, swelling, and joint||
2289|040|U|stiffness caused by arthritis, bursitis, and gout attacks. This||
2289|041|U|medication is known as a nonsteroidal anti-inflammatory drug||
2289|042|U|(NSAID). It works by blocking your body's production of certain||
2289|043|U|natural substances that cause inflammation.||
2289|044|U|   If you are treating a chronic condition such as arthritis, ask||
2289|045|U|your doctor about non-drug treatments and/or using other||
2289|046|U|medications to treat your pain. See also Warning section.||
2289|047|B|||
2289|048|H|HOW TO USE:  Read the Medication Guide provided by your||
2289|049|H|pharmacist before you start using naproxen and each time you get||
2289|050|H|a refill. If you have any questions, ask your doctor or||
2289|051|H|pharmacist.||
2289|052|H|   Shake the bottle well before each dose. Carefully measure the||
2289|053|H|dose using a special measuring device/spoon. Do not use a||
2289|054|H|household spoon because you may not get the correct dose. Take||
2289|055|H|this medication by mouth as directed by your doctor, usually 2||
2289|056|H|times a day. To prevent stomach upset, take this medication with||
2289|057|H|food, milk, or an antacid.||
2289|058|H|   The dosage is based on your medical condition and response to||
2289|059|H|treatment. Children's dosage is also based on weight. To reduce||
2289|060|H|your risk of stomach bleeding and other side effects, take this||
2289|061|H|medication at the lowest effective dose for the shortest possible||
2289|062|H|time. Do not increase your dose or take this drug more often than||
2289|063|H|directed. For ongoing conditions such as arthritis, keep taking||
2289|064|H|this medication as directed by your doctor.||
2289|065|H|   For certain conditions (such as arthritis), it may take up to||
2289|066|H|two weeks of taking this drug regularly until you get the full||
2289|067|H|benefit.||
2289|068|H|   If you are taking this drug "as needed" (not on a regular||
2289|069|H|schedule), remember that pain medications work best if they are||
2289|070|H|used as the first signs of pain occur. If you wait until the pain||
2289|071|H|has worsened, the medication may not work as well.||
2289|072|H|   Tell your doctor if your condition does not get better or if||
2289|073|H|it gets worse.||
2289|074|B|||
2289|075|S|SIDE EFFECTS:  See also Warning section.||
2289|076|S|   Upset stomach, nausea, heartburn, headache, drowsiness, or||
2289|077|S|dizziness may occur. If any of these effects last or get worse,||
2289|078|S|tell your doctor or pharmacist promptly.||
2289|079|S|   Remember that this medication has been prescribed because your||
2289|080|S|doctor has judged that the benefit to you is greater than the||
2289|081|S|risk of side effects. Many people using this medication do not||
2289|082|S|have serious side effects.||
2289|083|S|   This medication may raise your blood pressure. Check your||
2289|084|S|blood pressure regularly and tell your doctor if the results are||
2289|085|S|high.||
2289|086|S|   Tell your doctor right away if you have any serious side||
2289|087|S|effects, including: easy bruising/bleeding, hearing changes (such||
2289|088|S|as ringing in the ears), mental/mood changes, signs of kidney||
2289|089|S|problems (such as change in the amount of urine), vision changes,||
2289|090|S|symptoms of heart failure (such as swelling ankles/feet, unusual||
2289|091|S|tiredness, unusual/sudden weight gain).||
2289|092|S|   This drug may rarely cause serious (possibly fatal) liver||
2289|093|S|disease. Get medical help right away if you have any symptoms of||
2289|094|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
2289|095|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
2289|096|S|eyes/skin.||
2289|097|S|   A very serious allergic reaction to this drug is rare.||
2289|098|S|However, get medical help right away if you notice any symptoms||
2289|099|S|of a serious allergic reaction, including: fever, swollen lymph||
2289|100|S|nodes, rash, itching/swelling (especially of the||
2289|101|S|face/tongue/throat), severe dizziness, trouble breathing.||
2289|102|S|   This is not a complete list of possible side effects. If you||
2289|103|S|notice other effects not listed above, contact your doctor or||
2289|104|S|pharmacist.||
2289|105|S|   In the US -||
2289|106|S|   Call your doctor for medical advice about side effects. You||
2289|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2289|108|S|www.fda.gov/medwatch.||
2289|109|S|   In Canada - Call your doctor for medical advice about side||
2289|110|S|effects. You may report side effects to Health Canada at||
2289|111|S|1-866-234-2345.||
2289|112|B|||
2289|113|P|PRECAUTIONS:  Before taking naproxen, tell your doctor or||
2289|114|P|pharmacist if you are allergic to it; or to aspirin or other||
2289|115|P|NSAIDs (such as ibuprofen, celecoxib); or if you have any other||
2289|116|P|allergies. This product may contain inactive ingredients, which||
2289|117|P|can cause allergic reactions or other problems. Talk to your||
2289|118|P|pharmacist for more details.||
2289|119|P|   Before taking this medication, tell your doctor or pharmacist||
2289|120|P|your medical history, especially of: asthma (including a history||
2289|121|P|of worsening breathing after taking aspirin or other NSAIDs),||
2289|122|P|blood disorders (such as anemia, bleeding/clotting problems),||
2289|123|P|growths in the nose (nasal polyps), heart disease (such as||
2289|124|P|previous heart attack), high blood pressure, liver disease,||
2289|125|P|stroke, throat/stomach/intestinal problems (such as bleeding,||
2289|126|P|heartburn, ulcers).||
2289|127|P|   Kidney problems can sometimes occur with the use of NSAID||
2289|128|P|medications, including naproxen. Problems are more likely to||
2289|129|P|occur if you are dehydrated, have heart failure or kidney||
2289|130|P|disease, are an older adult, or if you take certain medications||
2289|131|P|(see also Drug Interactions section). Drink plenty of fluids as||
2289|132|P|directed by your doctor to prevent dehydration and tell your||
2289|133|P|doctor right away if you have a change in the amount of urine.||
2289|134|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2289|135|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2289|136|P|machinery, or do anything that needs alertness until you can do||
2289|137|P|it safely. Talk to your doctor if you are using marijuana||
2289|138|P|(cannabis).||
2289|139|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
2289|140|P|and tobacco, especially when combined with this medicine, may||
2289|141|P|increase your risk for stomach bleeding. Limit alcohol and stop||
2289|142|P|smoking. Consult your doctor or pharmacist for more information.||
2289|143|P|   This medication may make you more sensitive to the sun. Limit||
2289|144|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2289|145|P|sunscreen and wear protective clothing when outdoors. Tell your||
2289|146|P|doctor right away if you get sunburned or have skin||
2289|147|P|blisters/redness.||
2289|148|P|   This medication contains salt (sodium). Tell your doctor if||
2289|149|P|you are on a salt-restricted diet.||
2289|150|P|   Before having surgery, tell your doctor or dentist about all||
2289|151|P|the products you use (including prescription drugs,||
2289|152|P|nonprescription drugs, and herbal products).||
2289|153|P|   Older adults may be at greater risk for stomach/intestinal||
2289|154|P|bleeding, kidney problems, heart attack, and stroke while using||
2289|155|P|this drug.||
2289|156|P|   Before using this medication, women of childbearing age should||
2289|157|P|talk with their doctor(s) about the benefits and risks. Tell your||
2289|158|P|doctor if you are pregnant or if you plan to become pregnant.||
2289|159|P|This medication may harm an unborn baby and cause problems with||
2289|160|P|normal labor/delivery. It is not recommended for use in pregnancy||
2289|161|P|from 20 weeks until delivery. If your doctor decides that you||
2289|162|P|need to use this medication between 20 and 30 weeks of pregnancy,||
2289|163|P|you should use the lowest effective dose for the shortest||
2289|164|P|possible time. You should not use this medication after 30 weeks||
2289|165|P|of pregnancy.||
2289|166|P|   This drug passes into breast milk and may have undesirable||
2289|167|P|effects on a nursing infant. Consult your doctor before||
2289|168|P|breastfeeding.||
2289|169|B|||
2289|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2289|171|I|medications work or increase your risk for serious side effects.||
2289|172|I|This document does not contain all possible drug interactions.||
2289|173|I|Keep a list of all the products you use (including||
2289|174|I|prescription/nonprescription drugs and herbal products) and share||
2289|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
2289|176|I|the dosage of any medicines without your doctor's approval.||
2289|177|I|   Products that may interact with this drug include: aliskiren,||
2289|178|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
2289|179|I|receptor blockers (such as losartan, valsartan), cidofovir,||
2289|180|I|corticosteroids (such as prednisone), lithium, "water pills"||
2289|181|I|(diuretics such as furosemide).||
2289|182|I|   This medication may increase the risk of bleeding when taken||
2289|183|I|with other drugs that also may cause bleeding. Examples include||
2289|184|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2289|185|I|dabigatran/enoxaparin/warfarin, among others.||
2289|186|I|   Check all prescription and nonprescription medicine labels||
2289|187|I|carefully since many medications contain pain relievers/fever||
2289|188|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
2289|189|I|ketorolac). These drugs are similar to naproxen and may increase||
2289|190|I|your risk of side effects if taken together. However, if your||
2289|191|I|doctor has told you to take low-dose aspirin to prevent heart||
2289|192|I|attack or stroke (usually 81-162 milligrams a day), you should||
2289|193|I|keep taking the aspirin unless your doctor tells you not to.||
2289|194|I|Daily use of naproxen may decrease aspirin's ability to prevent||
2289|195|I|heart attack/stroke. Talk with your doctor about the risks and||
2289|196|I|benefits. Ask about other medications that can be used to treat||
2289|197|I|pain/fever.||
2289|198|I|   This medication may interfere with certain lab tests, possibly||
2289|199|I|causing false test results. Make sure lab personnel and all your||
2289|200|I|doctors know you use this drug.||
2289|201|B|||
2289|202|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2289|203|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2289|204|O|poison control center right away. US residents can call||
2289|205|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2289|206|O|Symptoms of overdose may include: severe stomach pain, extreme||
2289|207|O|drowsiness, seizures.||
2289|208|B|||
2289|209|N|NOTES:  Do not share this medication with others.||
2289|210|N|   Lab and/or medical tests (such as blood pressure, complete||
2289|211|N|blood count, liver/kidney function) may be done while you are||
2289|212|N|taking this medication. Keep all medical and lab appointments.||
2289|213|N|Consult your doctor for more details.||
2289|214|N|   If you have arthritis, lifestyle changes (such as weight loss||
2289|215|N|if needed, strengthening/conditioning exercises) may help improve||
2289|216|N|your flexibility and joint function. Consult your doctor for||
2289|217|N|specific instructions.||
2289|218|B|||
2289|219|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
2289|220|D|(not just "as needed") and you miss a dose, take it as soon as||
2289|221|D|you remember. If it is near the time of the next dose, skip the||
2289|222|D|missed dose. Take your next dose at the regular time. Do not||
2289|223|D|double the dose to catch up.||
2289|224|B|||
2289|225|R|STORAGE:  Store at room temperature away from light. Keep all||
2289|226|R|medications away from children and pets.||
2289|227|R|   Do not flush medications down the toilet or pour them into a||
2289|228|R|drain unless instructed to do so. Properly discard this product||
2289|229|R|when it is expired or no longer needed. Consult your pharmacist||
2289|230|R|or local waste disposal company.||
2289|231|B|||
2289|232|A|Information last revised October 2024.||
2289|233|A|Copyright(c) 2025 First Databank, Inc.||
2289|234|B|||
2290|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2290|002|Z|does NOT have all possible information about this product. This||
2290|003|Z|information does not assure that this product is safe, effective,||
2290|004|Z|or appropriate for you. This information is not individual||
2290|005|Z|medical advice and does not substitute for the advice of your||
2290|006|Z|health care professional. Always ask your health care||
2290|007|Z|professional for complete information about this product and your||
2290|008|Z|specific health needs.||
2290|009|B|||
2290|010|T|NIFURTIMOX - ORAL||
2290|011|F|(ney-FURE-ti-mox)||
2290|012|B|||
2290|013|C|COMMON BRAND NAME(S): Lampit||
2290|014|B|||
2290|015|U|USES:  Nifurtimox is used to treat a certain parasitic infection||
2290|016|U|(Chagas disease). It works by stopping the growth of a certain||
2290|017|U|parasite.||
2290|018|B|||
2290|019|H|HOW TO USE:  Read the Patient Information Leaflet and||
2290|020|H|Instructions for Use if available from your pharmacist before you||
2290|021|H|start taking nifurtimox and each time you get a refill. If you||
2290|022|H|have any questions, ask your doctor or pharmacist.||
2290|023|H|   Take this medication by mouth with food as directed by your||
2290|024|H|doctor, usually 3 times a day. The dosage is based on your||
2290|025|H|weight.||
2290|026|H|   Do not drink alcohol while taking this medication. Doing so||
2290|027|H|may increase the risk of side effects from nifurtimox.||
2290|028|H|   If you have trouble swallowing the tablet, carefully read and||
2290|029|H|follow the Instructions for Use. If you need to split tablet(s)||
2290|030|H|for your dose, follow the directions to split the tablet(s) by||
2290|031|H|hand. Do not use a tablet splitting device. Dissolve the dose in||
2290|032|H|one-half teaspoonful (2.5 milliliters) water. Drink the mixture||
2290|033|H|right away with food. Ask your pharmacist or doctor if you have||
2290|034|H|any questions.||
2290|035|H|   Use this medication regularly to get the most benefit from it.||
2290|036|H|To help you remember, take this medication at the same times each||
2290|037|H|day.||
2290|038|H|   Continue to take this medication until the full prescribed||
2290|039|H|amount is finished, even if symptoms disappear after a few days.||
2290|040|H|Stopping the medication too early may result in a return of the||
2290|041|H|infection.||
2290|042|H|   Tell your doctor if your condition does not get better or if||
2290|043|H|it gets worse.||
2290|044|B|||
2290|045|S|SIDE EFFECTS:  Abdominal pain, nausea/vomiting, loss of appetite,||
2290|046|S|headache, fever, dizziness, or diarrhea may occur. If any of||
2290|047|S|these effects last or get worse, tell your doctor or pharmacist||
2290|048|S|promptly.||
2290|049|S|   Loss of appetite may cause weight loss. Your doctor should||
2290|050|S|check your weight regularly (such as every 2 weeks) and may||
2290|051|S|adjust your dose if needed.||
2290|052|S|   Remember that this medication has been prescribed because your||
2290|053|S|doctor has judged that the benefit to you is greater than the||
2290|054|S|risk of side effects. Many people using this medication do not||
2290|055|S|have serious side effects.||
2290|056|S|   Tell your doctor right away if you have any serious side||
2290|057|S|effects, including: new or worsening of mental/mood/behavior||
2290|058|S|problems.||
2290|059|S|   A very serious allergic reaction to this drug is rare.||
2290|060|S|However, get medical help right away if you notice any symptoms||
2290|061|S|of a serious allergic reaction, including: fever that doesn't go||
2290|062|S|away, new or worsening lymph node swelling, rash,||
2290|063|S|itching/swelling (especially of the face/tongue/throat), severe||
2290|064|S|dizziness, trouble breathing.||
2290|065|S|   This is not a complete list of possible side effects. If you||
2290|066|S|notice other effects not listed above, contact your doctor or||
2290|067|S|pharmacist.||
2290|068|S|   In the US -||
2290|069|S|   Call your doctor for medical advice about side effects. You||
2290|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2290|071|S|www.fda.gov/medwatch.||
2290|072|S|   In Canada - Call your doctor for medical advice about side||
2290|073|S|effects. You may report side effects to Health Canada at||
2290|074|S|1-866-234-2345.||
2290|075|B|||
2290|076|P|PRECAUTIONS:  Before taking nifurtimox, tell your doctor or||
2290|077|P|pharmacist if you are allergic to it; or if you have any other||
2290|078|P|allergies. This product may contain inactive ingredients, which||
2290|079|P|can cause allergic reactions or other problems. Talk to your||
2290|080|P|pharmacist for more details.||
2290|081|P|   Before using this medication, tell your doctor or pharmacist||
2290|082|P|your medical history, especially of: a certain inherited blood||
2290|083|P|problem (porphyria), brain injury, kidney problems, liver||
2290|084|P|problems, mental/mood/behavior problems, seizures.||
2290|085|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2290|086|P|can make you more dizzy. Do not drive, use machinery, or do||
2290|087|P|anything that needs alertness until you can do it safely. Avoid||
2290|088|P|alcoholic beverages. Talk to your doctor if you are using||
2290|089|P|marijuana (cannabis).||
2290|090|P|   Before having surgery, tell your doctor or dentist about all||
2290|091|P|the products you use (including prescription drugs,||
2290|092|P|nonprescription drugs, and herbal products).||
2290|093|P|   This drug may affect genetic information in cells (genotoxic).||
2290|094|P|Talk to your doctor about the risks and benefits of this||
2290|095|P|medication.||
2290|096|P|   Tell your doctor if you are pregnant or plan to become||
2290|097|P|pregnant. You should not become pregnant while using nifurtimox.||
2290|098|P|Nifurtimox may harm an unborn baby. Your doctor should order a||
2290|099|P|pregnancy test before you start this medication. Women using this||
2290|100|P|medication should ask about reliable forms of birth control||
2290|101|P|during treatment and for 6 months after the last dose. Men using||
2290|102|P|this medication should ask about reliable forms of birth control||
2290|103|P|during treatment and for 3 months after the last dose. If you or||
2290|104|P|your partner becomes pregnant, talk to your doctor right away||
2290|105|P|about the risks and benefits of this medication.||
2290|106|P|   This medication passes into breast milk and may have||
2290|107|P|undesirable effects on a nursing infant. Tell the doctor right||
2290|108|P|away if your baby develops vomiting, decreased appetite, fever,||
2290|109|P|or irritability. Consult your doctor for more details.||
2290|110|B|||
2290|111|I|DRUG INTERACTIONS:  See also How to Use section.||
2290|112|I|   Drug interactions may change how your medications work or||
2290|113|I|increase your risk for serious side effects. This document does||
2290|114|I|not contain all possible drug interactions. Keep a list of all||
2290|115|I|the products you use (including prescription/nonprescription||
2290|116|I|drugs and herbal products) and share it with your doctor and||
2290|117|I|pharmacist. Do not start, stop, or change the dosage of any||
2290|118|I|medicines without your doctor's approval.||
2290|119|B|||
2290|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2290|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2290|122|O|poison control center right away. US residents can call||
2290|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2290|124|B|||
2290|125|N|NOTES:  Do not share this medication with others.||
2290|126|N|   Lab and/or medical tests (such as complete blood count,||
2290|127|N|kidney/liver function) may be done while you are taking this||
2290|128|N|medication. Keep all medical and lab appointments.||
2290|129|B|||
2290|130|D|MISSED DOSE:  If you miss a dose, take it with food as soon as||
2290|131|D|you remember. If it is less than 3 hours before the next dose,||
2290|132|D|skip the missed dose. Take your next dose at the regular time. Do||
2290|133|D|not double the dose to catch up.||
2290|134|B|||
2290|135|R|STORAGE:  Store in the original container at room temperature||
2290|136|R|away from light and moisture. Do not store in the bathroom. Keep||
2290|137|R|the drying agent (desiccant) in the bottle. Tightly close the||
2290|138|R|bottle when not in use. Keep all medications away from children||
2290|139|R|and pets.||
2290|140|R|   Do not flush medications down the toilet or pour them into a||
2290|141|R|drain unless instructed to do so. Properly discard this product||
2290|142|R|when it is expired or no longer needed. Consult your pharmacist||
2290|143|R|or local waste disposal company.||
2290|144|B|||
2290|145|A|Information last revised July 2024.||
2290|146|A|Copyright(c) 2025 First Databank, Inc.||
2290|147|B|||
2291|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2291|002|Z|does NOT have all possible information about this product. This||
2291|003|Z|information does not assure that this product is safe, effective,||
2291|004|Z|or appropriate for you. This information is not individual||
2291|005|Z|medical advice and does not substitute for the advice of your||
2291|006|Z|health care professional. Always ask your health care||
2291|007|Z|professional for complete information about this product and your||
2291|008|Z|specific health needs.||
2291|009|B|||
2291|010|T|AMOXICILLIN/CLAVULANIC ACID - INJECTION||
2291|011|F|(a-MOX-i-SIL-in/KLAV-ue-LAN-ik AS-id)||
2291|012|B|||
2291|013|U|USES:  This combination medication is used to treat a wide||
2291|014|U|variety of bacterial infections. It is known as a penicillin-type||
2291|015|U|antibiotic. It works by stopping the growth of bacteria.||
2291|016|B|||
2291|017|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2291|018|H|from your pharmacist before you start using||
2291|019|H|amoxicillin/clavulanic acid and each time you get a refill. If||
2291|020|H|you have any questions, ask your doctor or pharmacist.||
2291|021|H|   This medication is given by injection into a vein as directed||
2291|022|H|by your doctor, usually every 8 or 12 hours. The dosage is based||
2291|023|H|on your medical condition and response to treatment. Children's||
2291|024|H|dosage is also based on weight.||
2291|025|H|   If you are using this medication at home, learn all||
2291|026|H|preparation and usage instructions from your health care||
2291|027|H|professional. Before using, check this product for particles or||
2291|028|H|discoloration. If either is present, do not use the liquid. Learn||
2291|029|H|how to store and discard medical supplies safely.||
2291|030|H|   Give aminoglycosides (such as gentamicin) separately from this||
2291|031|H|medication. Do not mix together in the same IV fluid.||
2291|032|H|   For the best effect, use this antibiotic at evenly spaced||
2291|033|H|times. To help you remember, use this medication at the same||
2291|034|H|time(s) every day.||
2291|035|H|   Continue to use this medication until the full prescribed||
2291|036|H|amount is finished, even if symptoms disappear after a few days.||
2291|037|H|Stopping the medication too early may result in a return of the||
2291|038|H|infection.||
2291|039|H|   Tell your doctor if your condition lasts or gets worse.||
2291|040|B|||
2291|041|S|SIDE EFFECTS:  Dizziness, nausea, vomiting, or diarrhea may||
2291|042|S|occur. If any of these effects last or get worse, tell your||
2291|043|S|doctor or pharmacist promptly.||
2291|044|S|   Remember that this medication has been prescribed because your||
2291|045|S|doctor has judged that the benefit to you is greater than the||
2291|046|S|risk of side effects. Many people using this medication do not||
2291|047|S|have serious side effects.||
2291|048|S|   Tell your doctor right away if you have any serious side||
2291|049|S|effects, including: pain/swelling at injection site,||
2291|050|S|difficult/painful urination, easy bruising/bleeding, signs of||
2291|051|S|liver disease (such as nausea/vomiting that doesn't stop, loss of||
2291|052|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2291|053|S|urine).||
2291|054|S|   This medication may rarely cause a severe intestinal condition||
2291|055|S|due to a bacteria called C. difficile. This condition may occur||
2291|056|S|during treatment or weeks to months after treatment has stopped.||
2291|057|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2291|058|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2291|059|S|stool.||
2291|060|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2291|061|S|products because they may make symptoms worse.||
2291|062|S|   This medication may sometimes cause oral thrush or a new yeast||
2291|063|S|infection. Contact your doctor if you notice white patches in||
2291|064|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2291|065|S|   Amoxicillin can commonly cause a mild rash that is usually not||
2291|066|S|serious. However, you may not be able to tell it apart from a||
2291|067|S|rare rash that could be a sign of a severe allergic reaction. Get||
2291|068|S|medical help right away if you develop any rash.||
2291|069|S|   A very serious allergic reaction to this drug is rare.||
2291|070|S|However, get medical help right away if you notice any symptoms||
2291|071|S|of a serious allergic reaction, including: fever that doesn't go||
2291|072|S|away, new or worsening lymph node swelling, rash,||
2291|073|S|itching/swelling (especially of the face/tongue/throat), severe||
2291|074|S|dizziness, trouble breathing.||
2291|075|S|   This is not a complete list of possible side effects. If you||
2291|076|S|notice other effects not listed above, contact your doctor or||
2291|077|S|pharmacist.||
2291|078|S|   In the US -||
2291|079|S|   Call your doctor for medical advice about side effects. You||
2291|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2291|081|S|www.fda.gov/medwatch.||
2291|082|S|   In Canada - Call your doctor for medical advice about side||
2291|083|S|effects. You may report side effects to Health Canada at||
2291|084|S|1-866-234-2345.||
2291|085|B|||
2291|086|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2291|087|P|pharmacist if you are allergic to it; or to penicillin or||
2291|088|P|cephalosporin antibiotics; or if you have any other allergies.||
2291|089|P|This product may contain inactive ingredients, which can cause||
2291|090|P|allergic reactions or other problems. Talk to your pharmacist for||
2291|091|P|more details.||
2291|092|P|   Before using this medication, tell your doctor or pharmacist||
2291|093|P|your medical history, especially of: viral infections (such as||
2291|094|P|infectious mononucleosis), kidney disease, liver disease||
2291|095|P|(especially if caused by past use of amoxicillin/clavulanic||
2291|096|P|acid).||
2291|097|P|   This medication may make you dizzy. Alcohol or marijuana||
2291|098|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
2291|099|P|or do anything that needs alertness until you can do it safely.||
2291|100|P|Limit alcoholic beverages. Talk to your doctor if you are using||
2291|101|P|marijuana (cannabis).||
2291|102|P|   This medication contains sodium. Consult your doctor or||
2291|103|P|pharmacist if you are on a salt-restricted diet or if you have a||
2291|104|P|condition that could be worsened by an increase in salt intake||
2291|105|P|(such as heart failure).||
2291|106|P|   This medication may cause live bacterial vaccines (such as||
2291|107|P|typhoid vaccine) to not work well. Tell your health care||
2291|108|P|professional that you are using this medication before having any||
2291|109|P|immunizations/vaccinations.||
2291|110|P|   During pregnancy, this medication should be used only when||
2291|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
2291|112|P|   This medication passes into breast milk. Consult your doctor||
2291|113|P|before breastfeeding.||
2291|114|B|||
2291|115|I|DRUG INTERACTIONS:  See also How to Use section.||
2291|116|I|   Drug interactions may change how your medications work or||
2291|117|I|increase your risk for serious side effects. This document does||
2291|118|I|not contain all possible drug interactions. Keep a list of all||
2291|119|I|the products you use (including prescription/nonprescription||
2291|120|I|drugs and herbal products) and share it with your doctor and||
2291|121|I|pharmacist. Do not start, stop, or change the dosage of any||
2291|122|I|medicines without your doctor's approval.||
2291|123|I|   This medication may interfere with certain lab tests (such as||
2291|124|I|certain urine glucose tests), possibly causing false test||
2291|125|I|results. Make sure lab personnel and all your doctors know you||
2291|126|I|use this drug.||
2291|127|B|||
2291|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2291|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2291|130|O|poison control center right away. US residents can call||
2291|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2291|132|O|Symptoms of overdose may include: seizures.||
2291|133|B|||
2291|134|N|NOTES:  If you are using this medication for a longer time, lab||
2291|135|N|tests (such as kidney function, complete blood count) may be done||
2291|136|N|while you are using this medication. Keep all medical and lab||
2291|137|N|appointments. Consult your doctor for more details.||
2291|138|B|||
2291|139|D|MISSED DOSE:  It is important to get each dose of this medication||
2291|140|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2291|141|D|right away for a new dosing schedule.||
2291|142|B|||
2291|143|R|STORAGE:  Consult the product instructions and your pharmacist||
2291|144|R|for storage details. Keep all medications away from children and||
2291|145|R|pets.||
2291|146|R|   Do not flush medications down the toilet or pour them into a||
2291|147|R|drain unless instructed to do so. Properly discard this product||
2291|148|R|when it is expired or no longer needed. Consult your pharmacist||
2291|149|R|or local waste disposal company.||
2291|150|B|||
2291|151|A|Information last revised December 2024.||
2291|152|A|Copyright(c) 2025 First Databank, Inc.||
2291|153|B|||
2292|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2292|002|Z|does NOT have all possible information about this product. This||
2292|003|Z|information does not assure that this product is safe, effective,||
2292|004|Z|or appropriate for you. This information is not individual||
2292|005|Z|medical advice and does not substitute for the advice of your||
2292|006|Z|health care professional. Always ask your health care||
2292|007|Z|professional for complete information about this product and your||
2292|008|Z|specific health needs.||
2292|009|B|||
2292|010|T|LEVAMLODIPINE - ORAL||
2292|011|F|(LEE-vam-LOE-di-peen)||
2292|012|B|||
2292|013|C|COMMON BRAND NAME(S): Conjupri||
2292|014|B|||
2292|015|U|USES:  Levamlodipine is used with or without other medications to||
2292|016|U|treat high blood pressure. Lowering high blood pressure helps||
2292|017|U|prevent strokes, heart attacks, and kidney problems.||
2292|018|U|Levamlodipine belongs to a class of drugs known as calcium||
2292|019|U|channel blockers. It works by relaxing blood vessels so blood can||
2292|020|U|flow more easily.||
2292|021|B|||
2292|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2292|023|H|from your pharmacist before you start taking levamlodipine and||
2292|024|H|each time you get a refill. If you have any questions, ask your||
2292|025|H|doctor or pharmacist.||
2292|026|H|   Take this medication by mouth with or without food as directed||
2292|027|H|by your doctor, usually once daily.||
2292|028|H|   The dosage is based on your medical condition and response to||
2292|029|H|treatment. Your doctor may gradually increase your dose. Follow||
2292|030|H|your doctor's instructions carefully.||
2292|031|H|   Use this medication regularly to get the most benefit from it.||
2292|032|H|To help you remember, take it at the same time each day. Keep||
2292|033|H|taking this medication even if you feel well. Most people with||
2292|034|H|high blood pressure do not feel sick.||
2292|035|H|   Tell your doctor if your condition does not get better or if||
2292|036|H|it gets worse (your blood pressure readings remain high or||
2292|037|H|increase).||
2292|038|B|||
2292|039|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, swelling||
2292|040|S|ankles/feet, tiredness, or flushing may occur. If any of these||
2292|041|S|effects last or get worse, tell your doctor or pharmacist||
2292|042|S|promptly.||
2292|043|S|   To reduce the risk of dizziness and lightheadedness, get up||
2292|044|S|slowly when rising from a sitting or lying position.||
2292|045|S|   Remember that this medication has been prescribed because your||
2292|046|S|doctor has judged that the benefit to you is greater than the||
2292|047|S|risk of side effects. Many people using this medication do not||
2292|048|S|have serious side effects.||
2292|049|S|   Tell your doctor right away if you have any serious side||
2292|050|S|effects, including: fast/irregular/pounding heartbeat, fainting.||
2292|051|S|   Although this medication may be used to prevent chest pain||
2292|052|S|(angina), some people who already have heart disease may rarely||
2292|053|S|have worsening chest pain or a heart attack after starting this||
2292|054|S|medication or increasing the dose. Get medical help right away if||
2292|055|S|you have: worsening chest pain, symptoms of a heart attack (such||
2292|056|S|as chest/jaw/left arm pain, shortness of breath, unusual||
2292|057|S|sweating).||
2292|058|S|   A very serious allergic reaction to this drug is rare.||
2292|059|S|However, get medical help right away if you notice any symptoms||
2292|060|S|of a serious allergic reaction, including: rash, itching/swelling||
2292|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2292|062|S|breathing.||
2292|063|S|   This is not a complete list of possible side effects. If you||
2292|064|S|notice other effects not listed above, contact your doctor or||
2292|065|S|pharmacist.||
2292|066|S|   In the US -||
2292|067|S|   Call your doctor for medical advice about side effects. You||
2292|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2292|069|S|www.fda.gov/medwatch.||
2292|070|S|   In Canada - Call your doctor for medical advice about side||
2292|071|S|effects. You may report side effects to Health Canada at||
2292|072|S|1-866-234-2345.||
2292|073|B|||
2292|074|P|PRECAUTIONS:  Before taking levamlodipine, tell your doctor or||
2292|075|P|pharmacist if you are allergic to it; or to amlodipine; or if you||
2292|076|P|have any other allergies. This product may contain inactive||
2292|077|P|ingredients, which can cause allergic reactions or other||
2292|078|P|problems. Talk to your pharmacist for more details.||
2292|079|P|   Before using this medication, tell your doctor or pharmacist||
2292|080|P|your medical history, especially of: heart problems, liver||
2292|081|P|problems.||
2292|082|P|   This drug may make you drowsy or dizzy. Alcohol or marijuana||
2292|083|P|(cannabis) can make you more drowsy or dizzy. Do not drive, use||
2292|084|P|machinery, or do anything that needs alertness until you can do||
2292|085|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2292|086|P|are using marijuana (cannabis).||
2292|087|P|   Before having surgery, tell your doctor or dentist about all||
2292|088|P|the products you use (including prescription drugs,||
2292|089|P|nonprescription drugs, and herbal products).||
2292|090|P|   Older adults may be more sensitive to the effects of this||
2292|091|P|drug, especially dizziness.||
2292|092|P|   During pregnancy, this medication should be used only when||
2292|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
2292|094|P|   This drug passes into breast milk. Consult your doctor before||
2292|095|P|breastfeeding.||
2292|096|B|||
2292|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2292|098|I|medications work or increase your risk for serious side effects.||
2292|099|I|This document does not contain all possible drug interactions.||
2292|100|I|Keep a list of all the products you use (including||
2292|101|I|prescription/nonprescription drugs and herbal products) and share||
2292|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
2292|103|I|the dosage of any medicines without your doctor's approval.||
2292|104|I|   Some products have ingredients that could raise your blood||
2292|105|I|pressure. Tell your pharmacist what products you are using, and||
2292|106|I|ask how to use them safely (especially cough-and-cold products,||
2292|107|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
2292|108|B|||
2292|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2292|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2292|111|O|poison control center right away. US residents can call||
2292|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2292|113|O|Symptoms of overdose may include: fainting, severe dizziness.||
2292|114|B|||
2292|115|N|NOTES:  Do not share this medication with others.||
2292|116|N|   Lifestyle changes that may help this medication work better||
2292|117|N|include exercising, stopping smoking, and eating a||
2292|118|N|low-cholesterol/low-fat diet. Consult your doctor for more||
2292|119|N|details.||
2292|120|N|   Lab and/or medical tests (such as liver function, blood||
2292|121|N|pressure) should be done while you are taking this medication.||
2292|122|N|Keep all medical and lab appointments.||
2292|123|N|   Check your blood pressure and pulse (heart rate) regularly||
2292|124|N|while taking this medication. Learn how to check your own blood||
2292|125|N|pressure and pulse at home, and share the results with your||
2292|126|N|doctor.||
2292|127|B|||
2292|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2292|129|D|remember. If it is near the time of the next dose, skip the||
2292|130|D|missed dose. Take your next dose at the regular time. Do not||
2292|131|D|double the dose to catch up.||
2292|132|B|||
2292|133|R|STORAGE:  Store at room temperature away from light and moisture.||
2292|134|R|Do not store in the bathroom. Keep all medications away from||
2292|135|R|children and pets.||
2292|136|R|   Do not flush medications down the toilet or pour them into a||
2292|137|R|drain unless instructed to do so. Properly discard this product||
2292|138|R|when it is expired or no longer needed. Consult your pharmacist||
2292|139|R|or local waste disposal company.||
2292|140|B|||
2292|141|A|Information last revised May 2024.||
2292|142|A|Copyright(c) 2025 First Databank, Inc.||
2292|143|B|||
2293|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2293|002|Z|does NOT have all possible information about this product. This||
2293|003|Z|information does not assure that this product is safe, effective,||
2293|004|Z|or appropriate for you. This information is not individual||
2293|005|Z|medical advice and does not substitute for the advice of your||
2293|006|Z|health care professional. Always ask your health care||
2293|007|Z|professional for complete information about this product and your||
2293|008|Z|specific health needs.||
2293|009|B|||
2293|010|T|SODIUM/CALCIUM/MAGNESIUM/POTASSIUM OXYBATES SOLUTION - ORAL||
2293|011|F|(SOE-dee-um/KAL-see-um/mag-NEE-zee-um/poe-TAS-ee-um OX-i-bates)||
2293|012|B|||
2293|013|C|COMMON BRAND NAME(S): Xywav||
2293|014|B|||
2293|015|W|WARNING:  This medication is a very powerful central nervous||
2293|016|W|system (CNS) depressant with a high risk of abuse. It may cause||
2293|017|W|slow/shallow breathing or severe drowsiness at recommended doses.||
2293|018|W|This medication must be used only for the purpose that your||
2293|019|W|doctor prescribes. It is against the law to use this drug for any||
2293|020|W|other purposes. Abuse or misuse of this product can result in||
2293|021|W|seizures, severe difficulty breathing, loss of consciousness, and||
2293|022|W|even death. It must not be used with alcohol or other CNS||
2293|023|W|depressants (see also Drug Interactions section).||
2293|024|W|   To receive this medication in the United States, you must||
2293|025|W|understand, agree to, and carefully follow the requirements of||
2293|026|W|the REMS Program for this medication. If you live in Canada or||
2293|027|W|any other country, consult your doctor and pharmacist for your||
2293|028|W|country's regulations.||
2293|029|B|||
2293|030|U|USES:  This medication is used to treat narcolepsy, a condition||
2293|031|U|that causes severe daytime sleepiness. It can decrease daytime||
2293|032|U|sleepiness and also reduce the number of sudden short attacks of||
2293|033|U|weak/paralyzed muscles (known as cataplexy) that can occur in||
2293|034|U|patients with narcolepsy. It may also be used to treat a certain||
2293|035|U|sleep disorder (idiopathic hypersomnia). This medication is a||
2293|036|U|central nervous system depressant. It is a form of a drug known||
2293|037|U|as gamma hydroxybutyrate (GHB).||
2293|038|B|||
2293|039|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2293|040|H|provided by your pharmacist before you start using this||
2293|041|H|medication and each time you get a refill. If you have any||
2293|042|H|questions, ask your doctor or pharmacist.||
2293|043|H|   Take this medication by mouth at least 2 hours after eating as||
2293|044|H|directed by your doctor. This medication is usually taken in 2||
2293|045|H|separate doses if treating narcolepsy, or in 1 or 2 doses if||
2293|046|H|treating idiopathic hypersomnia. Prepare your doses as directed||
2293|047|H|before bedtime. The doses must each be mixed with 2 ounces (60||
2293|048|H|milliliters) of water. Take the first dose at bedtime while in||
2293|049|H|bed. If you are directed to take a second dose, set an alarm||
2293|050|H|clock to awaken you for the second dose in 2-and-a-half hours to||
2293|051|H|4 hours. Take the second dose while sitting in bed, and turn off||
2293|052|H|the alarm. Properly discard prepared doses if not used within 24||
2293|053|H|hours. If you have children or pets in the house, be sure to use||
2293|054|H|the caps that come with the medication cups in the||
2293|055|H|child-resistant position.||
2293|056|H|   The dosage is based on your medical condition, response to||
2293|057|H|treatment, and other medications you may be taking. Children's||
2293|058|H|dosage is also based on weight. Be sure to tell your doctor and||
2293|059|H|pharmacist about all the products you use (including prescription||
2293|060|H|drugs, nonprescription drugs, and herbal products). Your doctor||
2293|061|H|will gradually increase your dose over 1 to 2 weeks to lessen the||
2293|062|H|risk of side effects. This process will continue until your||
2293|063|H|doctor has found the right dose for you. Follow your doctor's||
2293|064|H|directions carefully. Do not increase your dose, take it more||
2293|065|H|often, or use it for longer than prescribed.||
2293|066|H|   Use this medication regularly to get the most benefit from it.||
2293|067|H|To help you remember, take it at the same times each night.||
2293|068|H|   If you suddenly stop using this medication, you may have||
2293|069|H|withdrawal symptoms (such as anxiety, psychosis, fast heartbeat,||
2293|070|H|trouble sleeping). To help prevent withdrawal, your doctor may||
2293|071|H|lower your dose slowly. Withdrawal is more likely if you have||
2293|072|H|used this product for a long time or in high doses. Tell your||
2293|073|H|doctor or pharmacist right away if you have withdrawal.||
2293|074|H|   Tell your doctor if your condition lasts or gets worse.||
2293|075|B|||
2293|076|S|SIDE EFFECTS:  See also Warning section.||
2293|077|S|   Drowsiness, dizziness, nausea, vomiting, decreased appetite,||
2293|078|S|diarrhea, increased sweating, tiredness, bedwetting, or headache||
2293|079|S|may occur. If any of these effects last or get worse, tell your||
2293|080|S|doctor or pharmacist promptly.||
2293|081|S|   Remember that this medication has been prescribed because your||
2293|082|S|doctor has judged that the benefit to you is greater than the||
2293|083|S|risk of side effects. Many people using this medication do not||
2293|084|S|have serious side effects.||
2293|085|S|   Tell your doctor right away if you have any serious side||
2293|086|S|effects, including: mental/mood changes (such as confusion,||
2293|087|S|hallucinations, agitation, depression, thoughts of suicide),||
2293|088|S|numb/tingling skin, shaking (tremor), sleepwalking.||
2293|089|S|   Get medical help right away if you have any very serious side||
2293|090|S|effects, including: difficult/slow/shallow breathing (especially||
2293|091|S|during sleep).||
2293|092|S|   A very serious allergic reaction to this drug is rare.||
2293|093|S|However, get medical help right away if you notice any symptoms||
2293|094|S|of a serious allergic reaction, including: rash, itching/swelling||
2293|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2293|096|S|breathing.||
2293|097|S|   This is not a complete list of possible side effects. If you||
2293|098|S|notice other effects not listed above, contact your doctor or||
2293|099|S|pharmacist.||
2293|100|S|   In the US -||
2293|101|S|   Call your doctor for medical advice about side effects. You||
2293|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2293|103|S|www.fda.gov/medwatch.||
2293|104|S|   In Canada - Call your doctor for medical advice about side||
2293|105|S|effects. You may report side effects to Health Canada at||
2293|106|S|1-866-234-2345.||
2293|107|B|||
2293|108|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2293|109|P|pharmacist if you are allergic to sodium oxybate, calcium||
2293|110|P|oxybate, magnesium oxybate, or potassium oxybate; or if you have||
2293|111|P|any other allergies. This product may contain inactive||
2293|112|P|ingredients, which can cause allergic reactions or other||
2293|113|P|problems. Talk to your pharmacist for more details.||
2293|114|P|   Before using this medication, tell your doctor or pharmacist||
2293|115|P|your medical history, especially of: a certain rare metabolic||
2293|116|P|condition (succinic semialdehyde dehydrogenase deficiency), liver||
2293|117|P|disease, breathing problems (such as sleep apnea, asthma),||
2293|118|P|personal/family history of regular use/abuse of drugs/alcohol,||
2293|119|P|mental/mood problems (such as depression, family/personal history||
2293|120|P|of suicidal thoughts/attempts).||
2293|121|P|   Sleep disorders may decrease your ability to react quickly.||
2293|122|P|Though this medication helps keep you awake during the day, you||
2293|123|P|still may not be able to safely do tasks that require alertness||
2293|124|P|(such as driving, flying). This drug may also make you dizzy.||
2293|125|P|Alcohol or marijuana (cannabis) can make you more dizzy. For||
2293|126|P|these reasons, do not drive, use machinery, or do anything that||
2293|127|P|needs alertness until you can do it safely. Always use great care||
2293|128|P|when doing these activities, and avoid them completely during at||
2293|129|P|least the first 6 hours after you take this medication. Avoid||
2293|130|P|alcoholic beverages because they increase the risk of serious||
2293|131|P|side effects. Talk to your doctor if you are using marijuana||
2293|132|P|(cannabis).||
2293|133|P|   Before having surgery, tell your doctor or dentist about all||
2293|134|P|the products you use (including prescription drugs,||
2293|135|P|nonprescription drugs, and herbal products).||
2293|136|P|   Older adults may be more sensitive to the side effects of this||
2293|137|P|drug, especially headaches.||
2293|138|P|   During pregnancy, this medication should be used only when||
2293|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
2293|140|P|   This drug passes into breast milk. Consult your doctor before||
2293|141|P|breastfeeding.||
2293|142|B|||
2293|143|I|DRUG INTERACTIONS:  See also Warning section.||
2293|144|I|   Drug interactions may change how your medications work or||
2293|145|I|increase your risk for serious side effects. This document does||
2293|146|I|not contain all possible drug interactions. Keep a list of all||
2293|147|I|the products you use (including prescription/nonprescription||
2293|148|I|drugs and herbal products) and share it with your doctor and||
2293|149|I|pharmacist. Do not start, stop, or change the dosage of any||
2293|150|I|medicines without your doctor's approval.||
2293|151|I|   The risk of serious side effects (such as slow/shallow||
2293|152|I|breathing, severe drowsiness/dizziness) may be increased if this||
2293|153|I|medication is taken with other products that may also cause||
2293|154|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2293|155|I|if you are using other products such as other opioid pain or||
2293|156|I|cough relievers (such as codeine, hydrocodone), alcohol,||
2293|157|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
2293|158|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2293|159|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2293|160|I|cetirizine, diphenhydramine).||
2293|161|I|   Check the labels on all your medicines (such as allergy or||
2293|162|I|cough-and-cold products) because they may contain ingredients||
2293|163|I|that cause drowsiness. Ask your pharmacist about using those||
2293|164|I|products safely.||
2293|165|B|||
2293|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2293|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2293|168|O|poison control center right away. US residents can call||
2293|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2293|170|O|Symptoms of overdose may include: lack of response, slow/shallow||
2293|171|O|breathing, seizures.||
2293|172|B|||
2293|173|N|NOTES:  Do not share this medication with others. Sharing it is||
2293|174|N|against the law.||
2293|175|B|||
2293|176|D|MISSED DOSE:  If you miss your first dose of the night, take it||
2293|177|D|as soon as you remember if it is before bedtime. If it is not at||
2293|178|D|bedtime or if it is your second dose that you missed, skip the||
2293|179|D|missed dose. Take your next dose at the regular time. Do not||
2293|180|D|double the dose to catch up.||
2293|181|B|||
2293|182|R|STORAGE:  Different brands of this medication have different||
2293|183|R|storage needs. Check the product package for instructions on how||
2293|184|R|to store your brand, or ask your pharmacist. Keep all medications||
2293|185|R|away from children and pets.||
2293|186|R|   Do not flush medications down the toilet or pour them into a||
2293|187|R|drain unless instructed to do so. Properly discard this product||
2293|188|R|when it is expired or no longer needed. For more details, read||
2293|189|R|the Medication Guide, or consult your pharmacist or local waste||
2293|190|R|disposal company.||
2293|191|B|||
2293|192|A|Information last revised September 2024.||
2293|193|A|Copyright(c) 2025 First Databank, Inc.||
2293|194|B|||
2294|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2294|002|Z|does NOT have all possible information about this product. This||
2294|003|Z|information does not assure that this product is safe, effective,||
2294|004|Z|or appropriate for you. This information is not individual||
2294|005|Z|medical advice and does not substitute for the advice of your||
2294|006|Z|health care professional. Always ask your health care||
2294|007|Z|professional for complete information about this product and your||
2294|008|Z|specific health needs.||
2294|009|B|||
2294|010|T|DIDANOSINE DELAYED-RELEASE - ORAL||
2294|011|F|(dye-DAN-oh-seen)||
2294|012|B|||
2294|013|C|COMMON BRAND NAME(S): Videx EC||
2294|014|B|||
2294|015|W|WARNING:  Rarely, didanosine has caused a severe (sometimes||
2294|016|W|fatal) pancreas problem (pancreatitis) when used alone or with||
2294|017|W|other HIV medicines. Immediately tell your doctor if you develop||
2294|018|W|symptoms of pancreatitis (such as nausea/vomiting that doesn't||
2294|019|W|stop, stomach/abdominal/back pain).||
2294|020|W|   Rarely, didanosine has caused a severe (sometimes fatal) liver||
2294|021|W|and blood problem (lactic acidosis). These problems may be more||
2294|022|W|likely in females or people who are overweight (obese).||
2294|023|W|Immediately tell your doctor if you develop symptoms of liver||
2294|024|W|problems (such as nausea that doesn't stop, stomach/abdominal||
2294|025|W|pain, dark urine, yellowing eyes/skin) or lactic acidosis (such||
2294|026|W|as rapid breathing, drowsiness, muscle aches, severe weakness).||
2294|027|W|Didanosine should not be used with a certain HIV medicine,||
2294|028|W|stavudine, due to increased risk of these serious side effects.||
2294|029|B|||
2294|030|U|USES:  This drug is used with other HIV medications to help||
2294|031|U|control HIV infection. It helps to decrease the amount of HIV in||
2294|032|U|your body so your immune system can work better. This lowers your||
2294|033|U|chance of getting HIV complications (such as new infections,||
2294|034|U|cancer) and improves your quality of life. Didanosine belongs to||
2294|035|U|a class of drugs known as nucleoside reverse transcriptase||
2294|036|U|inhibitors-NRTI.||
2294|037|U|   Didanosine is not a cure for HIV infection. To decrease your||
2294|038|U|risk of spreading HIV disease to others, continue to take all HIV||
2294|039|U|medications exactly as prescribed by your doctor. Use an||
2294|040|U|effective barrier method (latex or polyurethane condoms/dental||
2294|041|U|dams) during sexual activity as directed by your doctor. Do not||
2294|042|U|share personal items (such as needles/syringes, toothbrushes, and||
2294|043|U|razors) that may have contacted blood or other body fluids.||
2294|044|U|Consult your doctor or pharmacist for more details.||
2294|045|B|||
2294|046|H|HOW TO USE:  Read the Medication Guide provided by your||
2294|047|H|pharmacist before you start using didanosine and each time you||
2294|048|H|get a refill. If you have any questions, ask your doctor or||
2294|049|H|pharmacist.||
2294|050|H|   Take this medication by mouth on an empty stomach (at least 1||
2294|051|H|and 1/2 hours before or 2 hours after a meal) as directed by your||
2294|052|H|doctor, usually once daily. Swallow the capsules whole. Do not||
2294|053|H|crush, chew, or open the capsules. Doing so may decrease their||
2294|054|H|effectiveness.||
2294|055|H|   The dosage is based on your weight, medical condition, and||
2294|056|H|response to treatment.||
2294|057|H|   It is very important to keep taking this medication (and other||
2294|058|H|HIV medications) exactly as prescribed by your doctor. Do not||
2294|059|H|skip any doses. Do not increase your dose, take this drug more||
2294|060|H|often than prescribed, or stop taking it (or other HIV medicines)||
2294|061|H|even for a short time unless directed to do so by your doctor.||
2294|062|H|Skipping or changing your dose without approval from your doctor||
2294|063|H|may cause the amount of virus to increase, make the infection||
2294|064|H|more difficult to treat (resistant), or worsen side effects.||
2294|065|H|   For the best effect, take this medication at evenly spaced||
2294|066|H|times. To help you remember, take this medication at the same||
2294|067|H|time every day.||
2294|068|B|||
2294|069|S|SIDE EFFECTS:  See also Warning section.||
2294|070|S|   Headache or diarrhea may occur. If any of these effects last||
2294|071|S|or get worse, notify your doctor or pharmacist promptly.||
2294|072|S|   Remember that this medication has been prescribed because your||
2294|073|S|doctor has judged that the benefit to you is greater than the||
2294|074|S|risk of side effects. Many people using this medication do not||
2294|075|S|have serious side effects.||
2294|076|S|   As your immune system gets stronger, it can begin to fight off||
2294|077|S|infections you already had, possibly causing disease symptoms to||
2294|078|S|come back. You could also have symptoms if your immune system||
2294|079|S|becomes overactive. This reaction may happen at any time (soon||
2294|080|S|after starting HIV treatment or many months later). Tell your||
2294|081|S|doctor right away if you have any serious symptoms, including:||
2294|082|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
2294|083|S|that doesn't go away, headaches that are severe or don't go away,||
2294|084|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
2294|085|S|changes, signs of infection (such as sore throat that doesn't go||
2294|086|S|away, fever, chills, swollen lymph nodes, non-healing skin||
2294|087|S|sores), signs of an overactive thyroid (such as irritability,||
2294|088|S|nervousness, heat intolerance, fast/pounding/irregular heartbeat.||
2294|089|S|   This medication can cause severe nerve problems in the||
2294|090|S|hands/feet/legs (peripheral neuropathy). Symptoms may include||
2294|091|S|numbness/tingling/pain in the palms of the hand or soles of the||
2294|092|S|feet. If you experience any of these symptoms, contact your||
2294|093|S|doctor right away so that you can be monitored closely. Your||
2294|094|S|doctor may decide to reduce or stop your dose of didanosine.||
2294|095|S|   Tell your doctor right away if you have any serious side||
2294|096|S|effects, including: vision problems (such as blurred vision,||
2294|097|S|difficulty seeing colors), vomiting up blood, belly/abdominal||
2294|098|S|swelling, easy bruising or bleeding.||
2294|099|S|   Loss of body fat (such as in the face, arms, and legs) may||
2294|100|S|occur while you are taking this medication. This effect may be||
2294|101|S|permanent. Tell your doctor right away if you notice any changes||
2294|102|S|in body fat.||
2294|103|S|   A very serious allergic reaction to this drug is rare.||
2294|104|S|However, get medical help right away if you notice any symptoms||
2294|105|S|of a serious allergic reaction, including: rash, itching/swelling||
2294|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2294|107|S|breathing.||
2294|108|S|   This is not a complete list of possible side effects. If you||
2294|109|S|notice other effects not listed above, contact your doctor or||
2294|110|S|pharmacist.||
2294|111|S|   In the US -||
2294|112|S|   Call your doctor for medical advice about side effects. You||
2294|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2294|114|S|www.fda.gov/medwatch.||
2294|115|S|   In Canada - Call your doctor for medical advice about side||
2294|116|S|effects. You may report side effects to Health Canada at||
2294|117|S|1-866-234-2345.||
2294|118|B|||
2294|119|P|PRECAUTIONS:  Before taking didanosine, tell your doctor or||
2294|120|P|pharmacist if you are allergic to it; or if you have any other||
2294|121|P|allergies. This product may contain inactive ingredients, which||
2294|122|P|can cause allergic reactions or other problems. Talk to your||
2294|123|P|pharmacist for more details.||
2294|124|P|   Before using this medication, tell your doctor or pharmacist||
2294|125|P|your medical history, especially of: pancreatitis, kidney||
2294|126|P|problems, liver problems (such as hepatitis, cirrhosis), nerve||
2294|127|P|problems (such as peripheral neuropathy), alcohol use, high fat||
2294|128|P|levels in the blood (triglycerides), gall bladder problems (such||
2294|129|P|as gall stones), gout.||
2294|130|P|   Avoid alcoholic beverages because they may increase your risk||
2294|131|P|for liver problems and pancreatitis.||
2294|132|P|   Didanosine may increase your risk of a heart attack. Discuss||
2294|133|P|the risks and benefits of treatment with your doctor and ways to||
2294|134|P|lower your risk of heart disease. Tell your doctor if you have||
2294|135|P|heart problems, if you smoke, or if you have other conditions||
2294|136|P|that increase your risk of heart disease such as high blood||
2294|137|P|pressure, diabetes, or high cholesterol levels.||
2294|138|P|   Before having surgery, tell your doctor or dentist about all||
2294|139|P|the products you use (including prescription drugs,||
2294|140|P|nonprescription drugs, and herbal products).||
2294|141|P|   Older adults may be at greater risk for pancreatitis while||
2294|142|P|using this drug.||
2294|143|P|   During pregnancy, this medication should be used only when||
2294|144|P|clearly needed. Treatment can lower the risk of passing HIV||
2294|145|P|infection to your baby, and didanosine may be part of that||
2294|146|P|treatment. Discuss the risks and benefits with your doctor.||
2294|147|P|   It is unknown if this medication passes into breast milk.||
2294|148|P|Because breast milk may transmit HIV, consult your doctor before||
2294|149|P|breastfeeding.||
2294|150|B|||
2294|151|I|DRUG INTERACTIONS:  See also Warning section.||
2294|152|I|   Drug interactions may change how your medications work or||
2294|153|I|increase your risk for serious side effects. This document does||
2294|154|I|not contain all possible drug interactions. Keep a list of all||
2294|155|I|the products you use (including prescription/nonprescription||
2294|156|I|drugs and herbal products) and share it with your doctor and||
2294|157|I|pharmacist. Do not start, stop, or change the dosage of any||
2294|158|I|medicines without your doctor's approval.||
2294|159|I|   Some products that may interact with this drug include:||
2294|160|I|allopurinol, hydroxyurea, methadone, orlistat, drugs that are||
2294|161|I|known to cause nerve problems (such as isoniazid, vincristine),||
2294|162|I|drugs known to cause pancreatitis (such as pentamidine,||
2294|163|I|co-trimoxazole), ribavirin, stavudine.||
2294|164|B|||
2294|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2294|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2294|167|O|poison control center right away. US residents can call||
2294|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2294|169|B|||
2294|170|N|NOTES:  Do not share this medication with others.||
2294|171|N|   Lab and/or medical tests (such as eye exams, kidney/liver||
2294|172|N|function, complete blood count with platelets, viral load, T-cell||
2294|173|N|counts) should be done while you are taking this medication. Keep||
2294|174|N|all medical and lab appointments. Consult your doctor for more||
2294|175|N|details.||
2294|176|B|||
2294|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2294|178|D|remember. If it is near the time of the next dose, skip the||
2294|179|D|missed dose. Take your next dose at the regular time. Do not||
2294|180|D|double the dose to catch up.||
2294|181|B|||
2294|182|R|STORAGE:  Store at room temperature away from light and moisture.||
2294|183|R|Do not store in the bathroom. Keep all medications away from||
2294|184|R|children and pets.||
2294|185|R|   Do not flush medications down the toilet or pour them into a||
2294|186|R|drain unless instructed to do so. Properly discard this product||
2294|187|R|when it is expired or no longer needed. Consult your pharmacist||
2294|188|R|or local waste disposal company.||
2294|189|B|||
2294|190|A|Information last revised April 2025.||
2294|191|A|Copyright(c) 2025 First Databank, Inc.||
2294|192|B|||
2296|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2296|002|Z|does NOT have all possible information about this product. This||
2296|003|Z|information does not assure that this product is safe, effective,||
2296|004|Z|or appropriate for you. This information is not individual||
2296|005|Z|medical advice and does not substitute for the advice of your||
2296|006|Z|health care professional. Always ask your health care||
2296|007|Z|professional for complete information about this product and your||
2296|008|Z|specific health needs.||
2296|009|B|||
2296|010|T|BROLUCIZUMAB - INTRAOCULAR||
2296|011|F|(BROE-lue-SIZ-ue-mab)||
2296|012|B|||
2296|013|C|COMMON BRAND NAME(S): Beovu||
2296|014|B|||
2296|015|U|USES:  Brolucizumab is used to treat certain serious eye||
2296|016|U|conditions (wet age-related macular degeneration, diabetic||
2296|017|U|macular edema). This medication can help preserve vision and||
2296|018|U|prevent blindness. Brolucizumab belongs to a class of drugs known||
2296|019|U|as growth factor inhibitors. It works by slowing the growth of||
2296|020|U|abnormal new blood vessels in the eye and decreasing leakage from||
2296|021|U|these blood vessels.||
2296|022|B|||
2296|023|H|HOW TO USE:  This medication is given by injection into the||
2296|024|H|affected eye(s) by a health care professional. The affected eye||
2296|025|H|is numbed before each injection. After the injection, you will||
2296|026|H|remain in the doctor's office for a while, and your eye(s) and||
2296|027|H|vision will be monitored.||
2296|028|H|   The treatment schedule is based on your medical condition and||
2296|029|H|response to treatment. Your doctor will give you regularly||
2296|030|H|scheduled injections, usually once a month or every 6 weeks for||
2296|031|H|the first few doses, then every 8 to 12 weeks.||
2296|032|H|   Use this medication regularly to get the most benefit from it.||
2296|033|H|To help you remember, mark your calendar with a reminder.||
2296|034|H|   Tell your doctor if your condition does not get better or if||
2296|035|H|it gets worse.||
2296|036|B|||
2296|037|S|SIDE EFFECTS:  Injection site pain, feeling as if something is in||
2296|038|S|the eye, or increased tears may occur. If any of these effects||
2296|039|S|last or get worse, tell your doctor or pharmacist promptly.||
2296|040|S|   Remember that this medication has been prescribed because your||
2296|041|S|doctor has judged that the benefit to you is greater than the||
2296|042|S|risk of side effects. Many people using this medication do not||
2296|043|S|have serious side effects.||
2296|044|S|   Tell your doctor right away if you have any serious side||
2296|045|S|effects, including: floaters (blurry shapes that seem to float in||
2296|046|S|front of your eyes), swollen eyelids.||
2296|047|S|   Get medical help right away if you have any very serious side||
2296|048|S|effects, including: chest/jaw/left arm pain, shortness of breath,||
2296|049|S|unusual sweating, weakness on one side of the body, trouble||
2296|050|S|speaking, confusion.||
2296|051|S|   This medication may rarely increase your risk for developing||
2296|052|S|certain serious eye conditions (endophthalmitis or retinal||
2296|053|S|detachment). Get medical help right away if you notice any of||
2296|054|S|these symptoms in the affected eye(s): pain, redness, sensitivity||
2296|055|S|to light, blurred vision, sudden change in vision, decreased||
2296|056|S|vision.||
2296|057|S|   A very serious allergic reaction to this drug is rare.||
2296|058|S|However, get medical help right away if you notice any symptoms||
2296|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2296|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2296|061|S|breathing.||
2296|062|S|   This is not a complete list of possible side effects. If you||
2296|063|S|notice other effects not listed above, contact your doctor or||
2296|064|S|pharmacist.||
2296|065|S|   In the US -||
2296|066|S|   Call your doctor for medical advice about side effects. You||
2296|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2296|068|S|www.fda.gov/medwatch.||
2296|069|S|   In Canada - Call your doctor for medical advice about side||
2296|070|S|effects. You may report side effects to Health Canada at||
2296|071|S|1-866-234-2345.||
2296|072|B|||
2296|073|P|PRECAUTIONS:  Before using brolucizumab, tell your doctor or||
2296|074|P|pharmacist if you are allergic to it; or if you have any other||
2296|075|P|allergies. This product may contain inactive ingredients, which||
2296|076|P|can cause allergic reactions or other problems. Talk to your||
2296|077|P|pharmacist for more details.||
2296|078|P|   Before using this medication, tell your doctor or pharmacist||
2296|079|P|your medical history, especially of: current eye infection.||
2296|080|P|   This drug may cause blurred vision. Do not drive, use||
2296|081|P|machinery, or do anything that needs clear vision until you can||
2296|082|P|do it safely.||
2296|083|P|   Before having surgery, tell your doctor or dentist about all||
2296|084|P|the products you use (including prescription drugs,||
2296|085|P|nonprescription drugs, and herbal products).||
2296|086|P|   Tell your doctor if you are pregnant or plan to become||
2296|087|P|pregnant. You should not become pregnant while using||
2296|088|P|brolucizumab. Brolucizumab may harm an unborn baby. Ask about||
2296|089|P|reliable forms of birth control while using this medication and||
2296|090|P|for at least 1 month after the last dose. If you become pregnant,||
2296|091|P|talk to your doctor right away about the risks and benefits of||
2296|092|P|this medication.||
2296|093|P|   It is unknown if this drug passes into breast milk. Because of||
2296|094|P|the possible risk to the infant, breastfeeding is not recommended||
2296|095|P|while using this drug and for at least 1 month after the last||
2296|096|P|dose. Consult your doctor before breastfeeding.||
2296|097|B|||
2296|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2296|099|I|medications work or increase your risk for serious side effects.||
2296|100|I|This document does not contain all possible drug interactions.||
2296|101|I|Keep a list of all the products you use (including||
2296|102|I|prescription/nonprescription drugs and herbal products) and share||
2296|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
2296|104|I|the dosage of any medicines without your doctor's approval.||
2296|105|B|||
2296|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2296|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2296|108|O|poison control center right away. US residents can call||
2296|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2296|110|B|||
2296|111|N|NOTES:  Medical tests (such as eye exams) should be done while||
2296|112|N|you are using this medication. Keep all medical appointments.||
2296|113|N|Consult your doctor for more details.||
2296|114|B|||
2296|115|D|MISSED DOSE:  It is important to get each dose of this medication||
2296|116|D|as scheduled. If you miss a dose, ask your doctor right away for||
2296|117|D|a new dosing schedule.||
2296|118|B|||
2296|119|R|STORAGE:  Not applicable. This medication is given in a hospital||
2296|120|R|or doctor's office and will not be stored at home.||
2296|121|B|||
2296|122|A|Information last revised October 2024.||
2296|123|A|Copyright(c) 2025 First Databank, Inc.||
2296|124|B|||
2297|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2297|002|Z|does NOT have all possible information about this product. This||
2297|003|Z|information does not assure that this product is safe, effective,||
2297|004|Z|or appropriate for you. This information is not individual||
2297|005|Z|medical advice and does not substitute for the advice of your||
2297|006|Z|health care professional. Always ask your health care||
2297|007|Z|professional for complete information about this product and your||
2297|008|Z|specific health needs.||
2297|009|B|||
2297|010|T|HYDROCORTISONE GRANULES - ORAL||
2297|011|F|(HYE-droe-KOR-ti-sone)||
2297|012|B|||
2297|013|C|COMMON BRAND NAME(S): Alkindi||
2297|014|B|||
2297|015|U|USES:  Hydrocortisone is a man-made version of a natural||
2297|016|U|substance (cortisol) made by the adrenal gland. This drug is used||
2297|017|U|to treat low cortisol levels caused by diseases of the adrenal||
2297|018|U|gland (such as Addison's disease, adrenocortical insufficiency).||
2297|019|U|Hydrocortisone belongs to a class of drugs known as||
2297|020|U|corticosteroids. Corticosteroids are needed in many ways for the||
2297|021|U|body to function well. They are important for salt and water||
2297|022|U|balance and keeping blood pressure normal.||
2297|023|B|||
2297|024|V|OTHER USES:  This section contains uses of this drug that are not||
2297|025|V|listed in the approved professional labeling for the drug but||
2297|026|V|that may be prescribed by your health care professional. Use this||
2297|027|V|drug for a condition that is listed in this section only if it||
2297|028|V|has been so prescribed by your health care professional.||
2297|029|V|   Hydrocortisone may also be used for arthritis, blood/immune||
2297|030|V|system disorders, skin and eye conditions, breathing problems,||
2297|031|V|cancer, and severe allergies. Hydrocortisone may also be used for||
2297|032|V|COVID-19, but is only effective in hospitalized patients who need||
2297|033|V|extra oxygen or a mechanical ventilator to breathe.||
2297|034|B|||
2297|035|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2297|036|H|provided by your pharmacist before you start taking||
2297|037|H|hydrocortisone and each time you get a refill. If you have any||
2297|038|H|questions, ask your doctor or pharmacist.||
2297|039|H|   Take this medication by mouth as directed by your doctor,||
2297|040|H|usually 2 or 3 times a day. Take it with food or milk to prevent||
2297|041|H|stomach upset. This medication comes as granules inside a||
2297|042|H|capsule. Do not swallow the capsules whole. Make sure not to get||
2297|043|H|the capsules wet. To use this medication, open the capsule first.||
2297|044|H|You may take this medication by pouring it directly on your||
2297|045|H|tongue, or by pouring it on a spoon and placing the medication in||
2297|046|H|your mouth, or by sprinkling the granules onto a spoonful of cold||
2297|047|H|or room-temperature soft food (such as yogurt or applesauce)||
2297|048|H|before taking the medication. Do not mix the granules in liquid.||
2297|049|H|Do not chew or crush the granules. If taking with soft food, make||
2297|050|H|sure to swallow the mixture within 5 minutes after preparing.||
2297|051|H|Drink some fluids (such as water, milk) after taking the granules||
2297|052|H|to make sure all the medication is swallowed.||
2297|053|H|   This medication should not be given through a feeding tube.||
2297|054|H|   The dosage is based on your medical condition, body size, and||
2297|055|H|response to treatment.||
2297|056|H|   Do not stop taking this medication without consulting your||
2297|057|H|doctor. Some conditions may become worse when this drug is||
2297|058|H|suddenly stopped. Your dose may need to be gradually decreased.||
2297|059|H|If you vomit or spit up after taking a dose, contact your doctor||
2297|060|H|to see if you need to take another dose.||
2297|061|H|   If you suddenly stop using this medication, you may have||
2297|062|H|withdrawal symptoms (such as weakness, weight loss, nausea,||
2297|063|H|muscle pain, headache, tiredness, dizziness). To help prevent||
2297|064|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
2297|065|H|more likely if you have used hydrocortisone for a long time or in||
2297|066|H|high doses. Tell your doctor or pharmacist right away if you have||
2297|067|H|withdrawal.||
2297|068|H|   Tell your doctor if your condition does not get better or if||
2297|069|H|it gets worse.||
2297|070|B|||
2297|071|S|SIDE EFFECTS:  Nausea, vomiting, headache, trouble sleeping,||
2297|072|S|increased sweating, or acne may occur. If any of these effects||
2297|073|S|last or get worse, tell your doctor or pharmacist promptly.||
2297|074|S|   The granules may appear in your stool. This effect is harmless||
2297|075|S|because your body has already absorbed the medication.||
2297|076|S|   Remember that this medication has been prescribed because your||
2297|077|S|doctor has judged that the benefit to you is greater than the||
2297|078|S|risk of side effects. Many people using this medication do not||
2297|079|S|have serious side effects.||
2297|080|S|   Tell your doctor right away if you have any serious side||
2297|081|S|effects, including: signs of infection (such as sore throat that||
2297|082|S|doesn't go away, fever, chills), weakness, swelling ankles/feet,||
2297|083|S|unusual weight gain, vision problems (such as blurred vision),||
2297|084|S|easy bruising/bleeding, puffy face, mental/mood changes (such as||
2297|085|S|depression, mood swings, agitation), muscle pain/cramps, thinning||
2297|086|S|skin, slow wound healing, bone pain, menstrual period changes,||
2297|087|S|irregular heartbeat, seizures, red/purple spots on the skin,||
2297|088|S|symptoms of stomach/intestinal bleeding (such as||
2297|089|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
2297|090|S|coffee grounds).||
2297|091|S|   This medication may rarely make your blood sugar rise, which||
2297|092|S|can cause or worsen diabetes. Tell your doctor right away if you||
2297|093|S|have symptoms of high blood sugar such as increased||
2297|094|S|thirst/urination. If you already have diabetes, check your blood||
2297|095|S|sugar regularly as directed and share the results with your||
2297|096|S|doctor. Your doctor may need to adjust your diabetes medication,||
2297|097|S|exercise program, or diet.||
2297|098|S|   A very serious allergic reaction to this drug is rare.||
2297|099|S|However, get medical help right away if you notice any symptoms||
2297|100|S|of a serious allergic reaction, including: rash, itching/swelling||
2297|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2297|102|S|breathing.||
2297|103|S|   This is not a complete list of possible side effects. If you||
2297|104|S|notice other effects not listed above, contact your doctor or||
2297|105|S|pharmacist.||
2297|106|S|   In the US -||
2297|107|S|   Call your doctor for medical advice about side effects. You||
2297|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2297|109|S|www.fda.gov/medwatch.||
2297|110|S|   In Canada - Call your doctor for medical advice about side||
2297|111|S|effects. You may report side effects to Health Canada at||
2297|112|S|1-866-234-2345.||
2297|113|B|||
2297|114|P|PRECAUTIONS:  Before taking hydrocortisone, tell your doctor or||
2297|115|P|pharmacist if you are allergic to it; or if you have any other||
2297|116|P|allergies. This product may contain inactive ingredients, which||
2297|117|P|can cause allergic reactions or other problems. Talk to your||
2297|118|P|pharmacist for more details.||
2297|119|P|   Before using this medication, tell your doctor or pharmacist||
2297|120|P|your medical history, especially of: eye disease (such as||
2297|121|P|cataracts, glaucoma), heart problems (such as heart failure,||
2297|122|P|recent heart attack), high blood pressure, liver disease (such as||
2297|123|P|hepatitis B), kidney disease, thyroid problems, diabetes,||
2297|124|P|stomach/intestinal problems (such as diverticulitis, ulcer), bone||
2297|125|P|loss (osteoporosis), current/past infections (such as||
2297|126|P|tuberculosis, herpes, fungal infection), bleeding problems, blood||
2297|127|P|clots, mental/mood disorders (such as psychosis, anxiety,||
2297|128|P|depression), mineral imbalance (such as low level of||
2297|129|P|potassium/calcium in the blood), seizures, a certain adrenal||
2297|130|P|gland tumor (pheochromocytoma).||
2297|131|P|   This medication may cause stomach bleeding. Daily use of||
2297|132|P|alcohol while using this medication may increase your risk for||
2297|133|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
2297|134|P|or pharmacist for more information.||
2297|135|P|   Before having surgery, tell your doctor or dentist about all||
2297|136|P|the products you use (including prescription drugs,||
2297|137|P|nonprescription drugs, and herbal products).||
2297|138|P|   Using corticosteroid medications for a long time can make it||
2297|139|P|more difficult for your body to respond to physical stress.||
2297|140|P|Before having surgery or emergency treatment, or if you get a||
2297|141|P|serious illness/injury, tell your doctor or dentist that you are||
2297|142|P|using this medication or have used this medication within the||
2297|143|P|past 12 months. Tell your doctor right away if you develop||
2297|144|P|unusual/extreme tiredness or weight loss. If you will be using||
2297|145|P|this medication for a long time, carry a warning card or medical||
2297|146|P|ID bracelet that identifies your use of this medication.||
2297|147|P|   This medication may mask signs of infection. It can make you||
2297|148|P|more likely to get infections or may make current infections||
2297|149|P|worse. Stay away from anyone who has an infection that may easily||
2297|150|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2297|151|P|doctor if you have been exposed to an infection or for more||
2297|152|P|details.||
2297|153|P|   Tell your health care professional that you are using||
2297|154|P|hydrocortisone before having any immunizations/vaccinations.||
2297|155|P|Avoid contact with people who have recently received live||
2297|156|P|vaccines (such as flu vaccine inhaled through the nose).||
2297|157|P|   This medication may slow down a child's growth if used for a||
2297|158|P|long time. Consult the doctor or pharmacist for more details. See||
2297|159|P|the doctor regularly so your child's height and growth can be||
2297|160|P|checked.||
2297|161|P|   Older adults may be more sensitive to the effects of this||
2297|162|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
2297|163|P|mental/mood changes (such as confusion).||
2297|164|P|   During pregnancy, hydrocortisone should be used only when||
2297|165|P|clearly needed. Discuss the risks and benefits with your doctor.||
2297|166|P|Infants born to mothers who have been using this medication for||
2297|167|P|an extended period of time may have hormone problems. Tell your||
2297|168|P|doctor right away if you notice symptoms such as nausea/vomiting||
2297|169|P|that doesn't stop, severe diarrhea, or weakness in your newborn.||
2297|170|P|   It is unknown if this drug passes into breast milk. However,||
2297|171|P|this drug is unlikely to harm a nursing infant. Consult your||
2297|172|P|doctor before breastfeeding.||
2297|173|B|||
2297|174|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2297|175|I|medications work or increase your risk for serious side effects.||
2297|176|I|This document does not contain all possible drug interactions.||
2297|177|I|Keep a list of all the products you use (including||
2297|178|I|prescription/nonprescription drugs and herbal products) and share||
2297|179|I|it with your doctor and pharmacist. Do not start, stop, or change||
2297|180|I|the dosage of any medicines without your doctor's approval.||
2297|181|I|   Some products that may interact with this drug are:||
2297|182|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
2297|183|I|cause bleeding/bruising (such as antiplatelet drugs like||
2297|184|I|clopidogrel, NSAIDs like ibuprofen/naproxen, "blood thinners"||
2297|185|I|like warfarin/dabigatran).||
2297|186|I|   Aspirin can increase the risk of bleeding when used with this||
2297|187|I|medication. However, if your doctor has told you to take low-dose||
2297|188|I|aspirin to prevent heart attack or stroke (usually 81-162||
2297|189|I|milligrams a day), you should keep taking the aspirin unless your||
2297|190|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2297|191|I|details.||
2297|192|I|   This medication may interfere with certain lab tests (such as||
2297|193|I|skin tests), possibly causing false test results. Make sure lab||
2297|194|I|personnel and all your doctors know you use this drug.||
2297|195|B|||
2297|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2297|197|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2297|198|O|poison control center right away. US residents can call||
2297|199|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2297|200|B|||
2297|201|N|NOTES:  Do not share this medication with others.||
2297|202|N|   If this medication is used for an extended time, lab and/or||
2297|203|N|medical tests (such as blood sugar/mineral levels, blood counts,||
2297|204|N|blood pressure, bone density tests, eye exams, height/weight||
2297|205|N|measurements, X-rays) should be done while you are taking this||
2297|206|N|medication. Keep all medical and lab appointments. Consult your||
2297|207|N|doctor for more details.||
2297|208|N|   This medication may cause bone loss (osteoporosis) when used||
2297|209|N|for a long time. Lifestyle changes that may help reduce the risk||
2297|210|N|of bone problems include doing weight-bearing exercise, stopping||
2297|211|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2297|212|N|D. Talk to your doctor for more details.||
2297|213|B|||
2297|214|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2297|215|D|remember. If it is near the time of the next dose, skip the||
2297|216|D|missed dose. Take your next dose at the regular time. Do not||
2297|217|D|double the dose to catch up.||
2297|218|B|||
2297|219|R|STORAGE:  Store in the original bottle at room temperature away||
2297|220|R|from light and moisture. Do not store in the bathroom. Once the||
2297|221|R|bottle is opened, this medication expires after 60 days. Keep all||
2297|222|R|medications away from children and pets.||
2297|223|R|   Do not flush medications down the toilet or pour them into a||
2297|224|R|drain unless instructed to do so. Properly discard this product||
2297|225|R|when it is expired or no longer needed. Consult your pharmacist||
2297|226|R|or local waste disposal company.||
2297|227|B|||
2297|228|M|MEDICAL ALERT:  Your condition can cause complications in a||
2297|229|M|medical emergency. For information about enrolling in MedicAlert,||
2297|230|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2297|231|B|||
2297|232|A|Information last revised September 2025.||
2297|233|A|Copyright(c) 2025 First Databank, Inc.||
2297|234|B|||
2298|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2298|002|Z|does NOT have all possible information about this product. This||
2298|003|Z|information does not assure that this product is safe, effective,||
2298|004|Z|or appropriate for you. This information is not individual||
2298|005|Z|medical advice and does not substitute for the advice of your||
2298|006|Z|health care professional. Always ask your health care||
2298|007|Z|professional for complete information about this product and your||
2298|008|Z|specific health needs.||
2298|009|B|||
2298|010|T|TRAMADOL/ACETAMINOPHEN - ORAL||
2298|011|F|(TRAM-a-dol/a-SEET-a-MIN-oh-fen)||
2298|012|B|||
2298|013|C|COMMON BRAND NAME(S): Ultracet||
2298|014|B|||
2298|015|W|WARNING:  Tramadol/acetaminophen has a risk for abuse and||
2298|016|W|addiction, which can lead to overdose and death.||
2298|017|W|Tramadol/acetaminophen may also cause severe, possibly fatal,||
2298|018|W|breathing problems. To lower your risk, your doctor should have||
2298|019|W|you take the smallest dose of tramadol/acetaminophen that works,||
2298|020|W|and take it for the shortest possible time. See also How to Use||
2298|021|W|section for more information about addiction.||
2298|022|W|   Ask your doctor or pharmacist if you should have medication||
2298|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
2298|024|W|Teach your family or household members about the signs of an||
2298|025|W|opioid overdose and how to treat it.||
2298|026|W|   The risk for severe breathing problems is higher when you||
2298|027|W|start this medication and after a dose increase, or if you take||
2298|028|W|the wrong dose/strength. Taking this medication with alcohol or||
2298|029|W|other drugs that can cause drowsiness or breathing problems may||
2298|030|W|cause very serious side effects, including death. Also, other||
2298|031|W|medications can affect the removal of tramadol/acetaminophen from||
2298|032|W|your body, which may affect how tramadol/acetaminophen works. Be||
2298|033|W|sure you know how to take tramadol/acetaminophen and what other||
2298|034|W|drugs you should avoid taking with it. See also Drug Interactions||
2298|035|W|section. Get medical help right away if any of these very serious||
2298|036|W|side effects occur: slow/shallow breathing, unusual||
2298|037|W|lightheadedness, severe drowsiness/dizziness, difficulty waking||
2298|038|W|up.||
2298|039|W|   Keep this medicine in a safe place to prevent theft, misuse,||
2298|040|W|or abuse. If someone accidentally swallows this drug, get medical||
2298|041|W|help right away.||
2298|042|W|   One ingredient in this product is acetaminophen. Taking too||
2298|043|W|much acetaminophen may cause serious (possibly fatal) liver||
2298|044|W|disease. Adults should not take more than 4000 milligrams (4||
2298|045|W|grams) of acetaminophen a day. People with liver problems and||
2298|046|W|children should take less acetaminophen. Ask your doctor or||
2298|047|W|pharmacist how much acetaminophen is safe to take.||
2298|048|W|   Do not use with any other drug containing acetaminophen||
2298|049|W|without asking your doctor or pharmacist first. Acetaminophen is||
2298|050|W|in many nonprescription and prescription medications (such as||
2298|051|W|pain/fever drugs or cough-and-cold products). Check the labels on||
2298|052|W|all your medicines to see if they contain acetaminophen, and ask||
2298|053|W|your pharmacist if you are unsure.||
2298|054|W|   Get medical help right away if you take too much acetaminophen||
2298|055|W|(overdose), even if you feel well. Overdose symptoms may include||
2298|056|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
2298|057|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
2298|058|W|   Daily alcohol use, especially when combined with||
2298|059|W|acetaminophen, may damage your liver. Avoid alcohol.||
2298|060|W|   Before using this medication, women of childbearing age should||
2298|061|W|talk with their doctor(s) about the risks and benefits. Tell your||
2298|062|W|doctor if you are pregnant or if you plan to become pregnant.||
2298|063|W|During pregnancy, this medication should be used only when||
2298|064|W|clearly needed. It may slightly increase the risk of birth||
2298|065|W|defects if used during the first two months of pregnancy. Also,||
2298|066|W|using it for a long time or in high doses near the expected||
2298|067|W|delivery date may harm the unborn baby. To lessen the risk, take||
2298|068|W|the smallest effective dose for the shortest possible time.||
2298|069|W|Babies born to mothers who use this drug for a long time may||
2298|070|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
2298|071|W|doctor right away if you notice any symptoms in your newborn baby||
2298|072|W|such as crying that doesn't stop, slow/shallow breathing,||
2298|073|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
2298|074|W|difficulty gaining weight.||
2298|075|W|   Children younger than 18 years should not use products that||
2298|076|W|contain tramadol. Some children are more sensitive to tramadol||
2298|077|W|and have had very serious (rarely fatal) breathing problems such||
2298|078|W|as slow/shallow breathing (see also Side Effects section). The||
2298|079|W|risk is greater in children who are obese or have breathing||
2298|080|W|problems, or after certain surgeries (including tonsil/adenoid||
2298|081|W|removal). Talk with your doctor or pharmacist about the risks and||
2298|082|W|benefits of this medication.||
2298|083|B|||
2298|084|U|USES:  See also Warning section.||
2298|085|U|   This product is used to treat moderate to moderately severe||
2298|086|U|pain. It contains 2 medications: tramadol and acetaminophen.||
2298|087|U|Tramadol belongs to a class of drugs known as opioid analgesics.||
2298|088|U|It works in the brain to change how your body feels and responds||
2298|089|U|to pain. Acetaminophen is used to relieve pain, and it can also||
2298|090|U|reduce a fever.||
2298|091|B|||
2298|092|H|HOW TO USE:  See also Warning section.||
2298|093|H|   Read the Medication Guide provided by your pharmacist before||
2298|094|H|you start taking tramadol/acetaminophen and each time you get a||
2298|095|H|refill. If you have any questions, ask your doctor or pharmacist.||
2298|096|H|   Take this medication by mouth as directed by your doctor,||
2298|097|H|usually up to every 4 to 6 hours as needed for pain relief. You||
2298|098|H|may take this drug with or without food. If you have nausea, it||
2298|099|H|may help to take this drug with food. Ask your doctor or||
2298|100|H|pharmacist about other ways to decrease nausea (such as lying||
2298|101|H|down for 1 to 2 hours with as little head movement as possible).||
2298|102|H|   The dosage is based on your medical condition and response to||
2298|103|H|treatment. To reduce your risk of side effects, your doctor may||
2298|104|H|direct you to start this medication at a low dose and gradually||
2298|105|H|increase your dose. Follow your doctor's instructions carefully.||
2298|106|H|The maximum recommended dose is 8 tablets per day. Do not||
2298|107|H|increase your dose, take the medication more often, or take it||
2298|108|H|for a longer time than prescribed. Properly stop the medication||
2298|109|H|when so directed.||
2298|110|H|   Pain medications work best if they are used as the first signs||
2298|111|H|of pain occur. If you wait until the pain has worsened, the||
2298|112|H|medication may not work as well.||
2298|113|H|   If you have ongoing pain (such as due to arthritis), your||
2298|114|H|doctor may direct you to also take long-acting opioid||
2298|115|H|medications. In that case, this medication might be used for||
2298|116|H|sudden (breakthrough) pain only as needed. Other pain relievers||
2298|117|H|(such as naproxen, ibuprofen) may also be prescribed. Ask your||
2298|118|H|doctor or pharmacist about using tramadol safely with other||
2298|119|H|drugs.||
2298|120|H|   Suddenly stopping this medication may cause withdrawal,||
2298|121|H|especially if you have used it for a long time or in high doses.||
2298|122|H|To prevent withdrawal, your doctor may lower your dose slowly.||
2298|123|H|Tell your doctor or pharmacist right away if you have any||
2298|124|H|withdrawal symptoms such as restlessness, mental/mood changes||
2298|125|H|(including anxiety, trouble sleeping, thoughts of suicide),||
2298|126|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
2298|127|H|aches, or sudden changes in behavior.||
2298|128|H|   When this medication is used for a long time, it may not work||
2298|129|H|as well. Talk with your doctor if this medication stops working||
2298|130|H|well.||
2298|131|H|   Though it helps many people, this medication may sometimes||
2298|132|H|cause addiction. This risk may be higher if you have a||
2298|133|H|mental/mood disorder or a substance use disorder (such as overuse||
2298|134|H|of or addiction to drugs/alcohol). Take this medication exactly||
2298|135|H|as prescribed to lower the risk of addiction. Ask your doctor or||
2298|136|H|pharmacist for more details.||
2298|137|H|   Tell your doctor if your pain does not get better or if it||
2298|138|H|gets worse, or if you have any new pain.||
2298|139|B|||
2298|140|S|SIDE EFFECTS:  See also Warning section.||
2298|141|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
2298|142|S|drowsiness, or sweating may occur. Some of these side effects may||
2298|143|S|decrease after you have been using this medication for a while.||
2298|144|S|If any of these effects last or get worse, tell your doctor or||
2298|145|S|pharmacist promptly.||
2298|146|S|   To prevent constipation, eat dietary fiber, drink enough||
2298|147|S|water, and exercise. You may also need to take a laxative. Ask||
2298|148|S|your pharmacist which type of laxative is right for you.||
2298|149|S|   To reduce the risk of dizziness and lightheadedness, get up||
2298|150|S|slowly when rising from a sitting or lying position.||
2298|151|S|   Remember that this medication has been prescribed because your||
2298|152|S|doctor has judged that the benefit to you is greater than the||
2298|153|S|risk of side effects. Many people using this medication do not||
2298|154|S|have serious side effects.||
2298|155|S|   Tell your doctor right away if you have any serious side||
2298|156|S|effects, including: interrupted breathing during sleep (sleep||
2298|157|S|apnea), mental/mood changes (such as agitation, hallucinations),||
2298|158|S|severe stomach/abdominal pain, difficulty urinating, signs of||
2298|159|S|your adrenal glands not working well (such as loss of appetite,||
2298|160|S|unusual tiredness, weight loss), trouble swallowing.||
2298|161|S|   Get medical help right away if you have any very serious side||
2298|162|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2298|163|S|fainting, seizure.||
2298|164|S|   This medication may increase serotonin and rarely cause a very||
2298|165|S|serious condition called serotonin syndrome/toxicity. The risk||
2298|166|S|increases if you are also taking other drugs that increase||
2298|167|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2298|168|S|take (see Drug Interactions section). Get medical help right away||
2298|169|S|if you develop some of the following symptoms: fast heartbeat,||
2298|170|S|hallucinations, loss of coordination, severe dizziness, severe||
2298|171|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2298|172|S|unusual agitation/restlessness.||
2298|173|S|   Tramadol is changed into a strong opioid drug in your body. In||
2298|174|S|some people, this change happens faster and more completely than||
2298|175|S|usual, which increases the risk of very serious side effects. Get||
2298|176|S|medical help right away if you notice any of the following:||
2298|177|S|slow/shallow breathing, severe drowsiness/difficulty waking up,||
2298|178|S|confusion.||
2298|179|S|   A very serious allergic reaction to this drug is rare.||
2298|180|S|However, get medical help right away if you notice any of the||
2298|181|S|following symptoms: rash, itching/swelling (especially of the||
2298|182|S|face/tongue/throat), severe dizziness, trouble breathing.||
2298|183|S|   This is not a complete list of possible side effects. If you||
2298|184|S|notice other effects not listed above, contact your doctor or||
2298|185|S|pharmacist.||
2298|186|S|   In the US -||
2298|187|S|   Call your doctor for medical advice about side effects. You||
2298|188|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2298|189|S|www.fda.gov/medwatch.||
2298|190|S|   In Canada - Call your doctor for medical advice about side||
2298|191|S|effects. You may report side effects to Health Canada at||
2298|192|S|1-866-234-2345.||
2298|193|B|||
2298|194|P|PRECAUTIONS:  See also Warning section.||
2298|195|P|   Before taking this product, tell your doctor or pharmacist if||
2298|196|P|you are allergic to tramadol or acetaminophen; or if you have any||
2298|197|P|other allergies. This product may contain inactive ingredients,||
2298|198|P|which can cause allergic reactions or other problems. Talk to||
2298|199|P|your pharmacist for more details.||
2298|200|P|   Before using this medication, tell your doctor or pharmacist||
2298|201|P|your medical history, especially of: brain disorders (such as||
2298|202|P|head injury, tumor, seizures), breathing problems (such as||
2298|203|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
2298|204|P|kidney disease, liver disease, diabetes, mental/mood disorders||
2298|205|P|(such as confusion, depression, suicidal thoughts), personal or||
2298|206|P|family history of a substance use disorder (such as overuse of or||
2298|207|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
2298|208|P|blockage, constipation, diarrhea due to infection, paralytic||
2298|209|P|ileus), difficulty urinating (such as due to enlarged prostate),||
2298|210|P|gallbladder disease, disease of the pancreas (pancreatitis),||
2298|211|P|obesity.||
2298|212|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2298|213|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2298|214|P|machinery, or do anything that needs alertness until you can do||
2298|215|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2298|216|P|are using marijuana (cannabis).||
2298|217|P|   Tramadol/acetaminophen may cause a condition that affects the||
2298|218|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
2298|219|P|serious (rarely fatal) fast/irregular heartbeat and other||
2298|220|P|symptoms (such as severe dizziness, fainting) that need medical||
2298|221|P|attention right away.||
2298|222|P|   The risk of QT prolongation may be increased if you have||
2298|223|P|certain medical conditions or are taking other drugs that may||
2298|224|P|cause QT prolongation. Before using tramadol/acetaminophen, tell||
2298|225|P|your doctor or pharmacist of all the drugs you take and if you||
2298|226|P|have any of the following conditions: certain heart problems||
2298|227|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
2298|228|P|family history of certain heart problems (QT prolongation in the||
2298|229|P|EKG, sudden cardiac death).||
2298|230|P|   Low levels of potassium or magnesium in the blood may also||
2298|231|P|increase your risk of QT prolongation. This risk may increase if||
2298|232|P|you use certain drugs (such as diuretics/"water pills") or if you||
2298|233|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2298|234|P|Talk to your doctor about using tramadol/acetaminophen safely.||
2298|235|P|   Before having surgery, tell your doctor or dentist about all||
2298|236|P|the products you use (including prescription drugs,||
2298|237|P|nonprescription drugs, and herbal products).||
2298|238|P|   Some children may be more sensitive to very serious side||
2298|239|P|effects of tramadol, such as extreme sleepiness, confusion, or||
2298|240|P|slow/shallow/noisy breathing. (See also Warning section.)||
2298|241|P|   Older adults may be more sensitive to the side effects of this||
2298|242|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
2298|243|P|breathing, and QT prolongation (see above). Older adults may also||
2298|244|P|be more likely to develop a type of salt imbalance (hyponatremia)||
2298|245|P|while using this drug.||
2298|246|P|   During pregnancy, this medication should be used only when||
2298|247|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2298|248|P|benefits with your doctor. (See also Warning section.)||
2298|249|P|   This medication passes into breast milk and may have||
2298|250|P|undesirable effects on a nursing infant (such as unusual||
2298|251|P|sleepiness, difficulty feeding, or trouble breathing).||
2298|252|P|Breastfeeding is not recommended while using this medication.||
2298|253|P|Consult your doctor before breastfeeding.||
2298|254|B|||
2298|255|I|DRUG INTERACTIONS:  See also Warning section.||
2298|256|I|   Drug interactions may change how your medications work or||
2298|257|I|increase your risk for serious side effects. This document does||
2298|258|I|not contain all possible drug interactions. Keep a list of all||
2298|259|I|the products you use (including prescription/nonprescription||
2298|260|I|drugs and herbal products) and share it with your doctor and||
2298|261|I|pharmacist. Do not start, stop, or change the dosage of any||
2298|262|I|medicines without your doctor's approval.||
2298|263|I|   Some products that may interact with this drug include:||
2298|264|I|certain pain medications (mixed opioid agonist-antagonists such||
2298|265|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
2298|266|I|samidorphan.||
2298|267|I|   Taking MAO inhibitors with this medication may cause a serious||
2298|268|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2298|269|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2298|270|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2298|271|I|selegiline, tranylcypromine) during treatment with this||
2298|272|I|medication. Most MAO inhibitors should also not be taken for two||
2298|273|I|weeks before treatment with this medication. Ask your doctor when||
2298|274|I|to start or stop taking this medication.||
2298|275|I|   The risk of serotonin syndrome/toxicity increases if you are||
2298|276|I|also taking other drugs that increase serotonin. Examples include||
2298|277|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
2298|278|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2298|279|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2298|280|I|serotonin syndrome/toxicity may be more likely when you start or||
2298|281|I|increase the dose of these drugs.||
2298|282|I|   Other medications can affect the removal of tramadol from your||
2298|283|I|body, which may affect how tramadol works. Examples include azole||
2298|284|I|antifungals (such as itraconazole, ketoconazole),||
2298|285|I|levoketoconazole, macrolide antibiotics (such as erythromycin),||
2298|286|I|quinidine, rifamycins (such as rifampin), ritonavir, drugs used||
2298|287|I|to treat seizures (such as carbamazepine), among others.||
2298|288|I|   The risk of serious side effects (such as slow/shallow||
2298|289|I|breathing, severe drowsiness/dizziness) may be increased if this||
2298|290|I|medication is taken with other products that may also cause||
2298|291|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2298|292|I|if you are taking other products such as other opioid pain or||
2298|293|I|cough relievers (such as codeine, hydrocodone), alcohol,||
2298|294|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
2298|295|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2298|296|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2298|297|I|cetirizine, diphenhydramine).||
2298|298|I|   Check the labels on all your medicines (such as allergy or||
2298|299|I|cough-and-cold products) because they may contain ingredients||
2298|300|I|that cause drowsiness. Ask your pharmacist about using those||
2298|301|I|products safely.||
2298|302|I|   This medication may interfere with certain lab tests (such as||
2298|303|I|amylase/lipase levels), possibly causing false test results. Make||
2298|304|I|sure lab personnel and all your doctors know you use this drug.||
2298|305|B|||
2298|306|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2298|307|O|as passing out or trouble breathing, give them naloxone or||
2298|308|O|nalmefene if available, then call 911. If the person is awake and||
2298|309|O|has no symptoms, call a poison control center right away. US||
2298|310|O|residents can call 1-800-222-1222. Canada residents can call||
2298|311|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
2298|312|O|breathing, nausea, vomiting, loss of appetite, sweating,||
2298|313|O|slow/irregular heartbeat, stomach/abdominal pain, extreme||
2298|314|O|tiredness, yellowing eyes/skin, dark urine, seizure, coma.||
2298|315|B|||
2298|316|N|NOTES:  Do not share this medication with others. Sharing it is||
2298|317|N|against the law.||
2298|318|N|   This medication has been prescribed for your current condition||
2298|319|N|only. Do not use it later for another condition unless told to do||
2298|320|N|so by your doctor. A different medication may be necessary in||
2298|321|N|that case.||
2298|322|B|||
2298|323|D|MISSED DOSE:  Not applicable.||
2298|324|B|||
2298|325|R|STORAGE:  Store at room temperature away from light and moisture.||
2298|326|R|Keep all medications away from children and pets.||
2298|327|R|   Do not flush medications down the toilet or pour them into a||
2298|328|R|drain unless instructed to do so. Properly discard this product||
2298|329|R|when it is expired or no longer needed. Consult your pharmacist||
2298|330|R|or local waste disposal company.||
2298|331|B|||
2298|332|A|Information last revised August 2025.||
2298|333|A|Copyright(c) 2025 First Databank, Inc.||
2298|334|B|||
2302|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2302|002|Z|does NOT have all possible information about this product. This||
2302|003|Z|information does not assure that this product is safe, effective,||
2302|004|Z|or appropriate for you. This information is not individual||
2302|005|Z|medical advice and does not substitute for the advice of your||
2302|006|Z|health care professional. Always ask your health care||
2302|007|Z|professional for complete information about this product and your||
2302|008|Z|specific health needs.||
2302|009|B|||
2302|010|T|SETMELANOTIDE - INJECTION||
2302|011|F|(SET-me-LAN-oh-tide)||
2302|012|B|||
2302|013|C|COMMON BRAND NAME(S): Imcivree||
2302|014|B|||
2302|015|U|USES:  This medication is used to help you lose weight. It is||
2302|016|U|used by people who are overweight due to certain rare genetic||
2302|017|U|disorders. Setmelanotide works by controlling your appetite and||
2302|018|U|making you feel less hungry. It also increases the number of||
2302|019|U|calories that you burn.||
2302|020|B|||
2302|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2302|022|H|Instructions for Use if available from your pharmacist before you||
2302|023|H|start using setmelanotide and each time you get a refill. Ask||
2302|024|H|your health care professional how to prepare and use this||
2302|025|H|medication. If you have any questions, ask your doctor or||
2302|026|H|pharmacist.||
2302|027|H|   Inject this medication under the skin as directed by your||
2302|028|H|doctor, usually once daily in the morning when you first wake up.||
2302|029|H|The injection is given in the thigh, abdomen, or upper arm. This||
2302|030|H|medication may be used with or without food. The dosage is based||
2302|031|H|on your medical condition, age, and response to treatment.||
2302|032|H|Children's dosage may also be based on weight. Your doctor will||
2302|033|H|start you on a low dose first to decrease your risk of||
2302|034|H|stomach/abdominal side effects, and gradually increase your dose.||
2302|035|H|Follow your doctor's instructions carefully.||
2302|036|H|   Take the medication out of the refrigerator 15 minutes before||
2302|037|H|you inject it to allow it to reach room temperature. You may also||
2302|038|H|gently roll the vial in between your hands for 1 minute. Do not||
2302|039|H|warm up this medication any other way (for example, do not heat||
2302|040|H|it in the microwave or place it in hot water). Do not shake the||
2302|041|H|medication. Before using, check this product for particles or||
2302|042|H|discoloration. If either is present, do not use the liquid.||
2302|043|H|Before injecting each dose, clean the skin you are going to||
2302|044|H|inject into (the injection site) with rubbing alcohol. Change the||
2302|045|H|injection site each time to lessen injury under the skin. To||
2302|046|H|lessen bruising, do not rub the injection site after a shot.||
2302|047|H|Learn how to store and discard medical supplies safely.||
2302|048|H|   Use this medication regularly to get the most benefit from it.||
2302|049|H|To help you remember, use it at the same time each day.||
2302|050|B|||
2302|051|S|SIDE EFFECTS:  Darkening of the skin, nausea, vomiting, stomach||
2302|052|S|upset, diarrhea, or pain at injection site may occur. If any of||
2302|053|S|these effects last or get worse, tell your doctor or pharmacist||
2302|054|S|promptly.||
2302|055|S|   Remember that this medication has been prescribed because your||
2302|056|S|doctor has judged that the benefit to you is greater than the||
2302|057|S|risk of side effects. Many people using this medication do not||
2302|058|S|have serious side effects.||
2302|059|S|   Tell your doctor right away if you have any serious side||
2302|060|S|effects, including: mental/mood changes (such as depression,||
2302|061|S|thoughts of suicide), unusual skin changes (such as new moles or||
2302|062|S|change in the size/color of a mole), changes in sexual arousal.||
2302|063|S|   Rarely, males may have a painful or prolonged erection lasting||
2302|064|S|4 or more hours. If this occurs, stop using this drug and get||
2302|065|S|medical help right away, or permanent problems could occur.||
2302|066|S|   A very serious allergic reaction to this drug is rare.||
2302|067|S|However, get medical help right away if you notice any symptoms||
2302|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2302|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2302|070|S|breathing.||
2302|071|S|   This is not a complete list of possible side effects. If you||
2302|072|S|notice other effects not listed above, contact your doctor or||
2302|073|S|pharmacist.||
2302|074|S|   In the US -||
2302|075|S|   Call your doctor for medical advice about side effects. You||
2302|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2302|077|S|www.fda.gov/medwatch.||
2302|078|S|   In Canada - Call your doctor for medical advice about side||
2302|079|S|effects. You may report side effects to Health Canada at||
2302|080|S|1-866-234-2345.||
2302|081|B|||
2302|082|P|PRECAUTIONS:  Before using setmelanotide, tell your doctor or||
2302|083|P|pharmacist if you are allergic to it; or if you have any other||
2302|084|P|allergies. This product may contain inactive ingredients, which||
2302|085|P|can cause allergic reactions or other problems. Talk to your||
2302|086|P|pharmacist for more details.||
2302|087|P|   Before using this medication, tell your doctor or pharmacist||
2302|088|P|your medical history, especially of: mental/mood disorders (such||
2302|089|P|as depression, thoughts of suicide), skin problems (such as||
2302|090|P|moles, dark spots), kidney disease.||
2302|091|P|   Before having surgery, tell your doctor or dentist about all||
2302|092|P|the products you use (including prescription drugs,||
2302|093|P|nonprescription drugs, and herbal products).||
2302|094|P|   Children may be at greater risk for skin color changes or new||
2302|095|P|moles while using this drug.||
2302|096|P|   During pregnancy, this medication should be used only when||
2302|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
2302|098|P|   It is unknown if this drug passes into breast milk. Because of||
2302|099|P|the possible risk to the infant, breastfeeding is not recommended||
2302|100|P|while using this drug. Consult your doctor before breastfeeding.||
2302|101|B|||
2302|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2302|103|I|medications work or increase your risk for serious side effects.||
2302|104|I|This document does not contain all possible drug interactions.||
2302|105|I|Keep a list of all the products you use (including||
2302|106|I|prescription/nonprescription drugs and herbal products) and share||
2302|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
2302|108|I|the dosage of any medicines without your doctor's approval.||
2302|109|B|||
2302|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2302|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2302|112|O|poison control center right away. US residents can call||
2302|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2302|114|B|||
2302|115|N|NOTES:  Do not share this medication with others.||
2302|116|N|   Lab and/or medical tests (such as weight, skin exams) should||
2302|117|N|be done while you are using this medication. Keep all medical and||
2302|118|N|lab appointments.||
2302|119|B|||
2302|120|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
2302|121|D|next dose at the regular time. Do not double the dose to catch||
2302|122|D|up.||
2302|123|B|||
2302|124|R|STORAGE:  Store the unopened vial in the refrigerator. Do not||
2302|125|R|freeze. Store the opened vial in the refrigerator or at room||
2302|126|R|temperature away from heat and sunlight. Once the vial is opened||
2302|127|R|or stored at room temperature, this medication expires after 30||
2302|128|R|days. Keep all medications away from children and pets.||
2302|129|R|   Do not flush medications down the toilet or pour them into a||
2302|130|R|drain unless instructed to do so. Properly discard this product||
2302|131|R|when it is expired or no longer needed. Consult your pharmacist||
2302|132|R|or local waste disposal company.||
2302|133|B|||
2302|134|A|Information last revised December 2024.||
2302|135|A|Copyright(c) 2025 First Databank, Inc.||
2302|136|B|||
2304|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2304|002|Z|does NOT have all possible information about this product. This||
2304|003|Z|information does not assure that this product is safe, effective,||
2304|004|Z|or appropriate for you. This information is not individual||
2304|005|Z|medical advice and does not substitute for the advice of your||
2304|006|Z|health care professional. Always ask your health care||
2304|007|Z|professional for complete information about this product and your||
2304|008|Z|specific health needs.||
2304|009|B|||
2304|010|T|BUDESONIDE/FORMOTEROL POWDER INHALER - ORAL INHALATION||
2304|011|F|(bue-DES-oh-nide/for-MOE-ter-ol)||
2304|012|B|||
2304|013|U|USES:  This inhaler contains 2 medications: budesonide and||
2304|014|U|formoterol. It is used regularly as a long-term (maintenance)||
2304|015|U|treatment to prevent or decrease wheezing and trouble breathing||
2304|016|U|caused by asthma or ongoing lung disease (chronic obstructive||
2304|017|U|pulmonary disease-COPD, which includes chronic bronchitis and||
2304|018|U|emphysema). It works by relaxing the muscles around the airways||
2304|019|U|so that they open up and you can breathe more easily. Before||
2304|020|U|using this medication, it is important to learn how to use it||
2304|021|U|properly. This medication must be used regularly to prevent||
2304|022|U|breathing problems.||
2304|023|U|   This product may be prescribed to treat sudden breathing||
2304|024|U|problems caused by asthma (asthma attack), even though formoterol||
2304|025|U|is usually used to cause a slower, longer-lasting effect. To||
2304|026|U|treat an asthma attack, your doctor may instruct you to use this||
2304|027|U|product or a different quick-relief medicine/inhaler (such as||
2304|028|U|salbutamol, terbutaline). If you have COPD, this product should||
2304|029|U|not be used for sudden breathing problems. Your doctor should||
2304|030|U|instruct you to use a different quick-relief medicine/inhaler for||
2304|031|U|sudden COPD breathing problems. You should always have a||
2304|032|U|quick-relief inhaler with you.||
2304|033|U|   When used alone, long-acting beta agonists (such as||
2304|034|U|formoterol) may rarely increase the risk of serious (sometimes||
2304|035|U|fatal) asthma-related breathing problems. However, combination||
2304|036|U|inhaled corticosteroid and long-acting beta agonists, such as||
2304|037|U|this product, do not increase the risk of serious asthma-related||
2304|038|U|breathing problems. For asthma treatment, this product should be||
2304|039|U|used when breathing problems are not well controlled with one||
2304|040|U|asthma-control medication (such as inhaled corticosteroid) or if||
2304|041|U|your symptoms need combination treatment.||
2304|042|B|||
2304|043|H|HOW TO USE:  Read the Patient Information Leaflet and||
2304|044|H|Instructions for Use provided by your pharmacist before you start||
2304|045|H|using this medication and each time you get a refill. Follow the||
2304|046|H|illustrated directions for the proper use of this medication. If||
2304|047|H|you have any questions, ask your doctor or pharmacist.||
2304|048|H|   Inhale this medication as directed by your doctor, usually||
2304|049|H|once or twice daily. The dosage is based on your medical||
2304|050|H|condition and response to treatment.||
2304|051|H|   Use this medication regularly to receive the most benefit from||
2304|052|H|it. This medication works best if used at evenly spaced times. To||
2304|053|H|help you remember, use it at the same time(s) each day. Do not||
2304|054|H|increase your dose, use this medication more often, or stop using||
2304|055|H|it without talking with your doctor. Also, do not use other||
2304|056|H|long-acting beta agonists while using this medication.||
2304|057|H|   If your doctor has instructed you to use this product for||
2304|058|H|quick relief from an asthma attack, and symptoms continue after||
2304|059|H|the first inhalation, you may use another inhalation after a few||
2304|060|H|minutes. Do not use more than 6 inhalations to treat a single||
2304|061|H|asthma attack. Get medical help right away if symptoms last or||
2304|062|H|get worse.||
2304|063|H|   Do not shake the inhaler. To use the inhaler, hold the inhaler||
2304|064|H|upright. Unscrew and lift off the cover. Load the inhaler with a||
2304|065|H|dose by turning the grip as far as it will go in one direction||
2304|066|H|and then turning it back as far as it will go in the other||
2304|067|H|direction. Breathe out. Never breathe out through the mouthpiece.||
2304|068|H|Place the mouthpiece gently between your teeth and close your||
2304|069|H|lips. Do not chew or bite on the mouthpiece. Forcefully and||
2304|070|H|deeply inhale this medication by mouth. You may or may not||
2304|071|H|taste/feel the drug when you inhale. Remove the inhaler from your||
2304|072|H|mouth before breathing out. If your doctor has prescribed more||
2304|073|H|than 1 inhalation, repeat these steps. Always replace the cover||
2304|074|H|properly after using the inhaler.||
2304|075|H|   After the inhaler is loaded, if you accidentally drop, shake,||
2304|076|H|or breathe out into the inhaler, you will lose your dose. If this||
2304|077|H|happens, you should load a new dose and inhale it.||
2304|078|H|   If your prescribed dose is 2 puffs, wait at least one minute||
2304|079|H|between them. If you are using other inhalers at the same time,||
2304|080|H|wait at least 1 minute between the use of each medication, and||
2304|081|H|use this drug last.||
2304|082|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
2304|083|H|from developing, gargle, rinse your mouth with water and spit out||
2304|084|H|after each use. Do not swallow the rinse water.||
2304|085|H|   To clean your inhaler, wipe the outside of the mouthpiece once||
2304|086|H|a week with a dry tissue. Do not use water or other liquids. Do||
2304|087|H|not take the inhaler apart.||
2304|088|H|   If you are regularly taking corticosteroids by mouth (such as||
2304|089|H|prednisone), continue to follow your doctor's instructions on||
2304|090|H|taking them. Do not stop taking them. Your doctor may want you to||
2304|091|H|reduce your dose gradually.||
2304|092|H|   If you have been using a quick-relief inhaler (such as||
2304|093|H|salbutamol) on a regular daily schedule (such as 4 times daily),||
2304|094|H|you must stop this schedule and only use it as needed for sudden||
2304|095|H|shortness of breath/asthma attacks. Consult your doctor for||
2304|096|H|details.||
2304|097|H|   Learn which of your inhalers you should use every day||
2304|098|H|(controller drugs) and which you should use if your breathing||
2304|099|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
2304|100|H|time what you should do if you have new or worsening cough or||
2304|101|H|shortness of breath, wheezing, increased sputum, worsening peak||
2304|102|H|flow meter readings, waking up at night with trouble breathing,||
2304|103|H|if you use your quick-relief inhaler more often (more than 2 days||
2304|104|H|a week), or if your quick-relief inhaler does not seem to be||
2304|105|H|working well. Learn when you can treat sudden breathing problems||
2304|106|H|by yourself and when you must get medical help right away.||
2304|107|H|   It may take 1 week or longer before the full benefit of this||
2304|108|H|drug takes effect. Tell your doctor if your condition does not||
2304|109|H|get better or if it gets worse.||
2304|110|B|||
2304|111|S|SIDE EFFECTS:  Headache, nausea, nervousness, trouble sleeping,||
2304|112|S|cough, hoarseness or throat irritation may occur. If any of these||
2304|113|S|effects last or get worse, tell your doctor promptly.||
2304|114|S|   Remember that this medication has been prescribed because your||
2304|115|S|doctor has judged that the benefit to you is greater than the||
2304|116|S|risk of side effects. Many people using this medication do not||
2304|117|S|have serious side effects.||
2304|118|S|   This medication may raise your blood pressure. Check your||
2304|119|S|blood pressure regularly and tell your doctor if the results are||
2304|120|S|high.||
2304|121|S|   Rarely, this medication may cause sudden breathing||
2304|122|S|problems/asthma right after you use it. If this occurs, use your||
2304|123|S|quick-relief inhaler and get medical help right away.||
2304|124|S|   Tell your doctor right away if you have any serious side||
2304|125|S|effects, including: unusual weight gain, increased||
2304|126|S|thirst/urination, mental/mood changes (such as agitation,||
2304|127|S|depression), muscle cramps, shaking (tremors), vision problems||
2304|128|S|(such as blurred vision), signs of infection (such as sore throat||
2304|129|S|that doesn't go away, fever, chills), white patches on tongue/in||
2304|130|S|mouth.||
2304|131|S|   Get medical help right away if you have any very serious side||
2304|132|S|effects, including: chest pain, fast/slow/irregular heartbeat,||
2304|133|S|severe dizziness, fainting.||
2304|134|S|   A very serious allergic reaction to this product is rare.||
2304|135|S|However, get medical help right away if you notice any symptoms||
2304|136|S|of a serious allergic reaction, including: rash, itching/swelling||
2304|137|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2304|138|S|breathing.||
2304|139|S|   This is not a complete list of possible side effects. If you||
2304|140|S|notice other effects not listed above, contact your doctor or||
2304|141|S|pharmacist.||
2304|142|S|   In the US -||
2304|143|S|   Call your doctor for medical advice about side effects. You||
2304|144|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2304|145|S|www.fda.gov/medwatch.||
2304|146|S|   In Canada - Call your doctor for medical advice about side||
2304|147|S|effects. You may report side effects to Health Canada at||
2304|148|S|1-866-234-2345.||
2304|149|B|||
2304|150|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2304|151|P|pharmacist if you are allergic to it; or to arformoterol; or if||
2304|152|P|you have any other allergies. This product may contain inactive||
2304|153|P|ingredients (such as lactose, milk proteins), which can cause||
2304|154|P|allergic reactions or other problems. Talk to your pharmacist for||
2304|155|P|more details.||
2304|156|P|   Before using this medication, tell your doctor or pharmacist||
2304|157|P|your medical history, especially of: high blood pressure, bone||
2304|158|P|loss (osteoporosis), depression, diabetes, eye problems (such as||
2304|159|P|cataracts, glaucoma), heart problems (such as angina, irregular||
2304|160|P|heartbeat), any recent infection, liver problems, overactive||
2304|161|P|thyroid (hyperthyroidism), seizures, smoking, swelling of an||
2304|162|P|artery (aneurysm), a certain adrenal gland tumor||
2304|163|P|(pheochromocytoma).||
2304|164|P|   Budesonide/formoterol may cause a condition that affects the||
2304|165|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
2304|166|P|serious (rarely fatal) fast/irregular heartbeat and other||
2304|167|P|symptoms (such as severe dizziness, fainting) that need medical||
2304|168|P|attention right away.||
2304|169|P|   The risk of QT prolongation may be increased if you have||
2304|170|P|certain medical conditions or are taking other drugs that may||
2304|171|P|cause QT prolongation. Before using budesonide/formoterol, tell||
2304|172|P|your doctor or pharmacist of all the drugs you take and if you||
2304|173|P|have any of the following conditions: certain heart problems||
2304|174|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
2304|175|P|family history of certain heart problems (QT prolongation in the||
2304|176|P|EKG, sudden cardiac death).||
2304|177|P|   Low levels of potassium or magnesium in the blood may also||
2304|178|P|increase your risk of QT prolongation. This risk may increase if||
2304|179|P|you use certain drugs (such as diuretics/"water pills") or if you||
2304|180|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2304|181|P|Talk to your doctor about using budesonide/formoterol safely.||
2304|182|P|   This medication may mask signs of infection. It can make you||
2304|183|P|more likely to get infections or may make current infections||
2304|184|P|worse. Stay away from anyone who has an infection that may easily||
2304|185|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2304|186|P|doctor if you have been exposed to an infection or for more||
2304|187|P|details.||
2304|188|P|   If you have switched from a corticosteroid taken by mouth||
2304|189|P|(such as prednisone tablets) to this inhaler within the past 12||
2304|190|P|months, or if you have been using this product in||
2304|191|P|higher-than-usual doses for a long time, it may be more difficult||
2304|192|P|for your body to respond to physical stress. Before having||
2304|193|P|surgery or emergency treatment, or if you get a serious||
2304|194|P|illness/injury, tell your doctor or dentist that you are using||
2304|195|P|this medication or have used a corticosteroid taken by mouth||
2304|196|P|within the past 12 months. Tell your doctor right away if you||
2304|197|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
2304|198|P|card or medical ID bracelet that says you use (or have used)||
2304|199|P|corticosteroid medications.||
2304|200|P|   Before having surgery, tell your doctor or dentist about all||
2304|201|P|the products you use (including prescription drugs,||
2304|202|P|nonprescription drugs, and herbal products).||
2304|203|P|   This medication may temporarily slow down a child's growth if||
2304|204|P|used for a long time. However, poorly controlled asthma can also||
2304|205|P|slow down growth. See the doctor regularly so your child's height||
2304|206|P|can be checked.||
2304|207|P|   Older adults may be more sensitive to the side effects of this||
2304|208|P|drug, especially QT prolongation (see above).||
2304|209|P|   During pregnancy, this medication should be used only when||
2304|210|P|clearly needed. Discuss the risks and benefits with your doctor.||
2304|211|P|   Budesonide passes into breast milk. It is unknown if||
2304|212|P|formoterol passes into breast milk. Consult your doctor before||
2304|213|P|breastfeeding.||
2304|214|B|||
2304|215|I|DRUG INTERACTIONS:  See also Uses section.||
2304|216|I|   Drug interactions may change how your medications work or||
2304|217|I|increase your risk for serious side effects. This document does||
2304|218|I|not contain all possible drug interactions. Keep a list of all||
2304|219|I|the products you use (including prescription/nonprescription||
2304|220|I|drugs and herbal products) and share it with your doctor and||
2304|221|I|pharmacist. Do not start, stop, or change the dosage of any||
2304|222|I|medicines without your doctor's approval.||
2304|223|I|   Some products that may interact with this drug include:||
2304|224|I|aldesleukin, desmopressin, mifepristone.||
2304|225|B|||
2304|226|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2304|227|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2304|228|O|poison control center right away. US residents can call||
2304|229|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2304|230|O|Symptoms of overdose may include: shaking (tremors), dizziness,||
2304|231|O|fast/irregular heartbeat.||
2304|232|B|||
2304|233|N|NOTES:  Do not share this medication with others.||
2304|234|N|   Lab and/or medical tests (such as lung function, morning||
2304|235|N|cortisol levels, bone density tests, eye exams) may be done while||
2304|236|N|you are using this medication. Keep all medical and lab||
2304|237|N|appointments. Consult your doctor for more details.||
2304|238|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
2304|239|N|mold that can worsen breathing problems. Because the flu virus||
2304|240|N|can also worsen breathing problems, ask your doctor or pharmacist||
2304|241|N|if you should have a flu shot every year.||
2304|242|N|   This medication may cause bone loss (osteoporosis) in adults||
2304|243|N|when used for a long time. Lifestyle changes that may help reduce||
2304|244|N|the risk of bone problems include doing weight-bearing exercise,||
2304|245|N|stopping smoking, limiting alcohol, and getting enough calcium||
2304|246|N|and vitamin D. Talk to your doctor for more details.||
2304|247|B|||
2304|248|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2304|249|D|If it is near the time of the next dose, skip the missed dose.||
2304|250|D|Use your next dose at the regular time. Do not double the dose to||
2304|251|D|catch up.||
2304|252|B|||
2304|253|R|STORAGE:  Store at room temperature. Keep all medications away||
2304|254|R|from children and pets.||
2304|255|R|   Do not flush medications down the toilet or pour them into a||
2304|256|R|drain unless instructed to do so. Properly discard this product||
2304|257|R|when it is expired or no longer needed. Consult your pharmacist||
2304|258|R|or local waste disposal company.||
2304|259|B|||
2304|260|M|MEDICAL ALERT:  Your condition can cause complications in a||
2304|261|M|medical emergency. For information about enrolling in MedicAlert,||
2304|262|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2304|263|B|||
2304|264|A|Information last revised September 2025.||
2304|265|A|Copyright(c) 2025 First Databank, Inc.||
2304|266|B|||
2305|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2305|002|Z|does NOT have all possible information about this product. This||
2305|003|Z|information does not assure that this product is safe, effective,||
2305|004|Z|or appropriate for you. This information is not individual||
2305|005|Z|medical advice and does not substitute for the advice of your||
2305|006|Z|health care professional. Always ask your health care||
2305|007|Z|professional for complete information about this product and your||
2305|008|Z|specific health needs.||
2305|009|B|||
2305|010|T|COVID-19 VACCINE (MODERNA) - INJECTION||
2305|011|B|||
2305|012|C|COMMON BRAND NAME(S): mNexspike, Spikevax||
2305|013|B|||
2305|014|U|USES:  This vaccine is used to help prevent coronavirus disease,||
2305|015|U|also known as COVID-19. It works by increasing the body's natural||
2305|016|U|defense (immunity) against the virus. This vaccine may prevent||
2305|017|U|the illness, or reduce the seriousness of it.||
2305|018|U|   Vaccines may not fully protect everyone who receives them.||
2305|019|B|||
2305|020|H|HOW TO USE:  Read all vaccine information available from your||
2305|021|H|health care professional before receiving the vaccine. If you||
2305|022|H|have any questions, ask your health care professional.||
2305|023|H|   This vaccine is given by injection into a muscle by a health||
2305|024|H|care professional. It is given in the upper arm for children and||
2305|025|H|adults and in the thigh for infants. Closely follow the||
2305|026|H|vaccination schedule provided by the health care professional. To||
2305|027|H|help you remember, mark your calendar with a reminder.||
2305|028|B|||
2305|029|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
2305|030|S|tiredness, headache, fever, muscle/joint pain, chills, nausea,||
2305|031|S|vomiting, or swollen lymph nodes may occur. If any of these||
2305|032|S|effects last or get worse, tell your health care professional||
2305|033|S|promptly.||
2305|034|S|   Rarely, some people have symptoms such as fainting, dizziness,||
2305|035|S|vision changes, or ringing in the ears just after getting a||
2305|036|S|vaccine injection. Tell your health care professional right away||
2305|037|S|if you have any of these symptoms. Sitting or lying down may||
2305|038|S|help, since these symptoms usually don't last long.||
2305|039|S|   Remember that this vaccine has been prescribed because your||
2305|040|S|health care professional has judged that the benefit to you is||
2305|041|S|greater than the risk of side effects. Many people using this||
2305|042|S|vaccine do not have serious side effects.||
2305|043|S|   There have been rare reports of swelling of the heart muscle||
2305|044|S|(myocarditis) or the lining of the heart (pericarditis) that||
2305|045|S|usually occurred within a week after receiving this vaccine,||
2305|046|S|especially after the second dose. If you notice any of the||
2305|047|S|following symptoms, get medical help right away: chest pain,||
2305|048|S|shortness of breath, fast/pounding heartbeat.||
2305|049|S|   A very serious allergic reaction to this vaccine is rare. Get||
2305|050|S|medical help right away if you notice any symptoms of a serious||
2305|051|S|allergic reaction, including: rash, itching/swelling (especially||
2305|052|S|of the face/tongue/throat), severe dizziness, trouble breathing.||
2305|053|S|   This is not a complete list of possible side effects. If you||
2305|054|S|notice other effects not listed above, contact your health care||
2305|055|S|professional.||
2305|056|S|   Contact the doctor for medical advice about side effects. The||
2305|057|S|following numbers do not provide medical advice, but in the US||
2305|058|S|you may report side effects to the Vaccine Adverse Event||
2305|059|S|Reporting System (VAERS) at 1-800-822-7967. In Canada, you may||
2305|060|S|call the Vaccine Safety Section at Public Health Agency of Canada||
2305|061|S|at 1-866-844-0018.||
2305|062|B|||
2305|063|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
2305|064|P|care professional if you are allergic to it; or to polysorbate;||
2305|065|P|or if you have any other allergies. This product may contain||
2305|066|P|inactive ingredients (such as polyethylene glycol), which can||
2305|067|P|cause allergic reactions or other problems. Talk to your||
2305|068|P|pharmacist for more details.||
2305|069|P|   Before receiving this vaccine, tell your health care||
2305|070|P|professional your medical history, especially of: current||
2305|071|P|fever/illness, immune system disorders (such as those due to||
2305|072|P|cancer/radiation treatment), certain heart problems (myocarditis,||
2305|073|P|pericarditis), vaccination history (including previous reactions||
2305|074|P|to any vaccines).||
2305|075|P|   Tell your doctor if you are pregnant before using this||
2305|076|P|vaccine.||
2305|077|P|   It is unknown if this vaccine passes into breast milk. Consult||
2305|078|P|your health care professional before breastfeeding.||
2305|079|B|||
2305|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2305|081|I|medications work or increase your risk for serious side effects.||
2305|082|I|This document does not contain all possible drug interactions.||
2305|083|I|Keep a list of all the products you use (including||
2305|084|I|prescription/nonprescription drugs and herbal products) and share||
2305|085|I|it with your health care professional. Do not start, stop, or||
2305|086|I|change the dosage of any medicines without your doctor's||
2305|087|I|approval.||
2305|088|I|   Some products that may interact with this vaccine are: drugs||
2305|089|I|that weaken the immune system (including cyclosporine,||
2305|090|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
2305|091|I|prednisone).||
2305|092|B|||
2305|093|O|OVERDOSE:  Not applicable.||
2305|094|B|||
2305|095|N|NOTES:  Keep all medical and lab appointments.||
2305|096|N|   Keep vaccine records for yourself and your children and||
2305|097|N|provide them to the health care professionals to prevent||
2305|098|N|unnecessary re-vaccinations.||
2305|099|B|||
2305|100|D|MISSED DOSE:  It is important that you get each vaccination as||
2305|101|D|scheduled. Ask when you should get each dose and mark your||
2305|102|D|calendar with a reminder. If you miss a dose, call the health||
2305|103|D|care professional to reschedule.||
2305|104|B|||
2305|105|R|STORAGE:  Not applicable. This vaccine is given in a hospital or||
2305|106|R|clinic and will not be stored at home.||
2305|107|B|||
2305|108|A|Information last revised June 2025.||
2305|109|A|Copyright(c) 2025 First Databank, Inc.||
2305|110|B|||
2306|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2306|002|Z|does NOT have all possible information about this product. This||
2306|003|Z|information does not assure that this product is safe, effective,||
2306|004|Z|or appropriate for you. This information is not individual||
2306|005|Z|medical advice and does not substitute for the advice of your||
2306|006|Z|health care professional. Always ask your health care||
2306|007|Z|professional for complete information about this product and your||
2306|008|Z|specific health needs.||
2306|009|B|||
2306|010|T|IBUPROFEN/ACETAMINOPHEN - ORAL||
2306|011|F|(EYE-bue-PROE-fen/a-SEET-a-MIN-oh-fen)||
2306|012|B|||
2306|013|C|COMMON BRAND NAME(S): Advil Dual Action, Combogesic||
2306|014|B|||
2306|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
2306|016|W|ibuprofen) may rarely increase the risk for a heart attack or||
2306|017|W|stroke. This effect can happen at any time while taking this drug||
2306|018|W|but is more likely if you take it for a long time. The risk may||
2306|019|W|be greater in older adults or if you have heart disease or||
2306|020|W|increased risk for heart disease (for example, due to smoking,||
2306|021|W|family history of heart disease, or conditions such as high blood||
2306|022|W|pressure or diabetes). Do not take this drug right before or||
2306|023|W|after heart bypass surgery (CABG).||
2306|024|W|   One ingredient in this product is acetaminophen. Taking too||
2306|025|W|much acetaminophen may cause serious (possibly fatal) liver||
2306|026|W|disease. Adults should not take more than 4000 milligrams (4||
2306|027|W|grams) of acetaminophen a day. People with liver problems and||
2306|028|W|children should take less acetaminophen. Ask your doctor or||
2306|029|W|pharmacist how much acetaminophen is safe to take.||
2306|030|W|   Do not use with any other drug containing acetaminophen||
2306|031|W|without asking your doctor or pharmacist first. Acetaminophen is||
2306|032|W|in many nonprescription and prescription medications (such as||
2306|033|W|pain/fever drugs or cough-and-cold products). Check the labels on||
2306|034|W|all your medicines to see if they contain acetaminophen, and ask||
2306|035|W|your pharmacist if you are unsure.||
2306|036|W|   Get medical help right away if you take too much acetaminophen||
2306|037|W|(overdose), even if you feel well. Overdose symptoms may include||
2306|038|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
2306|039|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
2306|040|W|   Daily alcohol use, especially when combined with this product,||
2306|041|W|may damage your liver. Daily use of alcohol and tobacco may also||
2306|042|W|increase your risk for stomach bleeding. Avoid alcohol and stop||
2306|043|W|smoking.||
2306|044|W|   This drug may rarely cause serious (rarely fatal) bleeding||
2306|045|W|from the stomach or intestines. This effect can occur without||
2306|046|W|warning at any time while taking this drug. Older adults may be||
2306|047|W|at higher risk for this effect.||
2306|048|W|   Stop taking this medication and get medical help right away if||
2306|049|W|you notice any of these rare but serious side effects:||
2306|050|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
2306|051|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
2306|052|W|shortness of breath, unusual sweating, confusion, weakness on one||
2306|053|W|side of the body, trouble speaking, sudden vision changes.||
2306|054|W|   Talk to your doctor or pharmacist about the benefits and risks||
2306|055|W|of taking this drug.||
2306|056|B|||
2306|057|U|USES:  This medication contains 2 ingredients: ibuprofen and||
2306|058|U|acetaminophen. It is used to relieve pain from various conditions||
2306|059|U|such as headache, dental pain, menstrual cramps, muscle aches, or||
2306|060|U|arthritis. Ibuprofen is a nonsteroidal anti-inflammatory drug||
2306|061|U|(NSAID). This combination product works by blocking your body's||
2306|062|U|production of certain natural substances that cause inflammation.||
2306|063|U|This effect helps to decrease swelling, pain, or fever.||
2306|064|U|   If you are treating a chronic condition such as arthritis, ask||
2306|065|U|your doctor about non-drug treatments and/or using other||
2306|066|U|medications to treat your pain. See also Warning section.||
2306|067|U|   Check the ingredients on the label even if you have used the||
2306|068|U|product before. The manufacturer may have changed the||
2306|069|U|ingredients. Also, products with similar names may contain||
2306|070|U|different ingredients meant for different purposes. Taking the||
2306|071|U|wrong product could harm you.||
2306|072|B|||
2306|073|H|HOW TO USE:  Read all directions on the product package before||
2306|074|H|taking this medication. If your doctor has prescribed this||
2306|075|H|medication, read the Medication Guide provided by your pharmacist||
2306|076|H|before you start using this medication and each time you get a||
2306|077|H|refill. If you have any questions, ask your doctor or pharmacist.||
2306|078|H|   Take this medication by mouth as directed. Take with a full||
2306|079|H|glass of water (8 ounces or 240 milliliters) unless your doctor||
2306|080|H|directs you otherwise. Do not lie down for at least 10 minutes||
2306|081|H|after taking this medication. If stomach upset occurs while||
2306|082|H|taking this medication, take it with food, milk, or an antacid.||
2306|083|H|   The dosage is based on your medical condition and response to||
2306|084|H|treatment. To reduce your risk of stomach bleeding and other side||
2306|085|H|effects, use the lowest effective dose for the shortest possible||
2306|086|H|time. Do not increase your dose or take it for more than 10 days||
2306|087|H|unless otherwise directed. For ongoing conditions such as||
2306|088|H|arthritis, keep taking it as directed by your doctor. Discuss the||
2306|089|H|risks and benefits with your doctor or pharmacist.||
2306|090|H|   For certain conditions (such as arthritis), it may take up to||
2306|091|H|2 weeks of taking this drug regularly until you get the full||
2306|092|H|benefit.||
2306|093|H|   If you are taking this drug "as needed" (not on a regular||
2306|094|H|schedule), remember that pain medications work best if they are||
2306|095|H|used as the first signs of pain occur. If you wait until the pain||
2306|096|H|has worsened, the medication may not work as well.||
2306|097|H|   If your condition lasts or gets worse, or if you think you may||
2306|098|H|have a serious medical problem, get medical help right away. If||
2306|099|H|you are using this product to treat yourself or a child for fever||
2306|100|H|or pain, consult the doctor right away if fever gets worse or||
2306|101|H|lasts more than 3 days, or if pain gets worse or lasts more than||
2306|102|H|10 days.||
2306|103|B|||
2306|104|S|SIDE EFFECTS:  See also Warning section.||
2306|105|S|   Upset stomach, nausea, vomiting, headache, diarrhea,||
2306|106|S|constipation, dizziness, or drowsiness may occur. If any of these||
2306|107|S|effects last or get worse, tell your doctor or pharmacist||
2306|108|S|promptly.||
2306|109|S|   If your doctor has directed you to use this medication,||
2306|110|S|remember that your doctor has judged that the benefit to you is||
2306|111|S|greater than the risk of side effects. Many people using this||
2306|112|S|medication do not have serious side effects.||
2306|113|S|   This medication may raise your blood pressure. Check your||
2306|114|S|blood pressure regularly and tell your doctor if the results are||
2306|115|S|high.||
2306|116|S|   Tell your doctor right away if you have any serious side||
2306|117|S|effects, including: easy bruising/bleeding, hearing changes (such||
2306|118|S|as ringing in the ears), difficult/painful swallowing,||
2306|119|S|mental/mood changes, vision changes, unexplained stiff neck,||
2306|120|S|signs of kidney problems (such as change in the amount of urine),||
2306|121|S|symptoms of heart failure (such as swelling ankles/feet, unusual||
2306|122|S|tiredness, unusual/sudden weight gain).||
2306|123|S|   This product may rarely cause serious (possibly fatal) liver||
2306|124|S|disease. Get medical help right away if you have any symptoms of||
2306|125|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
2306|126|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2306|127|S|urine.||
2306|128|S|   A very serious allergic reaction to this drug is rare.||
2306|129|S|However, get medical help right away if you notice any symptoms||
2306|130|S|of a serious allergic reaction, including: fever, swollen lymph||
2306|131|S|nodes, rash, itching/swelling (especially of the||
2306|132|S|face/tongue/throat), severe dizziness, trouble breathing.||
2306|133|S|   This is not a complete list of possible side effects. If you||
2306|134|S|notice other effects not listed above, contact your doctor or||
2306|135|S|pharmacist.||
2306|136|S|   In the US -||
2306|137|S|   Call your doctor for medical advice about side effects. You||
2306|138|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2306|139|S|www.fda.gov/medwatch.||
2306|140|S|   In Canada - Call your doctor for medical advice about side||
2306|141|S|effects. You may report side effects to Health Canada at||
2306|142|S|1-866-234-2345.||
2306|143|B|||
2306|144|P|PRECAUTIONS:  See also Warning section.||
2306|145|P|   Before taking this medication, tell your doctor or pharmacist||
2306|146|P|if you are allergic to ibuprofen or acetaminophen; or to aspirin||
2306|147|P|or other NSAIDs (such as naproxen, celecoxib); or if you have any||
2306|148|P|other allergies. This product may contain inactive ingredients,||
2306|149|P|which can cause allergic reactions or other problems. Talk to||
2306|150|P|your pharmacist for more details.||
2306|151|P|   Before taking this medication, tell your doctor or pharmacist||
2306|152|P|your medical history, especially of: asthma (including a history||
2306|153|P|of worsening breathing after taking aspirin or other NSAIDs),||
2306|154|P|blood disorders (such as anemia, bleeding/clotting problems),||
2306|155|P|growths in the nose (nasal polyps), heart disease (such as||
2306|156|P|previous heart attack), high blood pressure, liver disease,||
2306|157|P|regular use/abuse of alcohol, stroke,||
2306|158|P|stomach/intestinal/esophagus problems (such as bleeding,||
2306|159|P|heartburn, ulcers).||
2306|160|P|   Kidney problems can sometimes occur with the use of NSAID||
2306|161|P|medications, including ibuprofen/acetaminophen. Problems are more||
2306|162|P|likely to occur if you are dehydrated, have heart failure or||
2306|163|P|kidney disease, are an older adult, or if you take certain||
2306|164|P|medications (see also Drug Interactions section). Drink plenty of||
2306|165|P|fluids as directed by your doctor to prevent dehydration and tell||
2306|166|P|your doctor right away if you have a change in the amount of||
2306|167|P|urine.||
2306|168|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2306|169|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2306|170|P|machinery, or do anything that needs alertness until you can do||
2306|171|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2306|172|P|are using marijuana (cannabis).||
2306|173|P|   This medication may make you more sensitive to the sun. Limit||
2306|174|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2306|175|P|sunscreen and wear protective clothing when outdoors. Tell your||
2306|176|P|doctor right away if you get sunburned or have skin||
2306|177|P|blisters/redness.||
2306|178|P|   Before having surgery, tell your doctor or dentist about all||
2306|179|P|the products you use (including prescription drugs,||
2306|180|P|nonprescription drugs, and herbal products).||
2306|181|P|   Older adults may be at greater risk for stomach/intestinal||
2306|182|P|bleeding, kidney problems, heart attack, and stroke while using||
2306|183|P|this drug.||
2306|184|P|   Before using this medication, women of childbearing age should||
2306|185|P|talk with their doctor(s) about the benefits and risks. Tell your||
2306|186|P|doctor if you are pregnant or if you plan to become pregnant.||
2306|187|P|This medication may harm an unborn baby and cause problems with||
2306|188|P|normal labor/delivery. It is not recommended for use in pregnancy||
2306|189|P|from 20 weeks until delivery. If your doctor decides that you||
2306|190|P|need to use this medication between 20 and 30 weeks of pregnancy,||
2306|191|P|you should use the lowest effective dose for the shortest||
2306|192|P|possible time. You should not use this medication after 30 weeks||
2306|193|P|of pregnancy.||
2306|194|P|   This medication passes into breast milk, but is unlikely to||
2306|195|P|harm a nursing infant. Consult your doctor before breastfeeding.||
2306|196|B|||
2306|197|I|DRUG INTERACTIONS:  See also Warning section.||
2306|198|I|   Drug interactions may change how your medications work or||
2306|199|I|increase your risk for serious side effects. This document does||
2306|200|I|not contain all possible drug interactions. Keep a list of all||
2306|201|I|the products you use (including prescription/nonprescription||
2306|202|I|drugs and herbal products) and share it with your doctor and||
2306|203|I|pharmacist. Do not start, stop, or change the dosage of any||
2306|204|I|medicines without your doctor's approval.||
2306|205|I|   Some products that may interact with this drug are: aliskiren,||
2306|206|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
2306|207|I|receptor blockers (such as losartan, valsartan), cidofovir,||
2306|208|I|corticosteroids (such as prednisone), ketoconazole,||
2306|209|I|levoketoconazole, lithium, methotrexate, "water pills" (diuretics||
2306|210|I|such as furosemide).||
2306|211|I|   This medication may increase the risk of bleeding when taken||
2306|212|I|with other drugs that also may cause bleeding. Examples include||
2306|213|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2306|214|I|dabigatran/enoxaparin/warfarin, among others.||
2306|215|I|   Check all prescription and nonprescription medicine labels||
2306|216|I|carefully since many medications contain pain relievers/fever||
2306|217|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
2306|218|I|or naproxen). These drugs are similar to ibuprofen and may||
2306|219|I|increase your risk of side effects if taken together. However, if||
2306|220|I|your doctor has told you to take low-dose aspirin to prevent||
2306|221|I|heart attack or stroke (usually 81-162 milligrams a day), you||
2306|222|I|should keep taking the aspirin unless your doctor tells you not||
2306|223|I|to. Daily use of ibuprofen may decrease aspirin's ability to||
2306|224|I|prevent heart attack/stroke. Talk to your doctor about using a||
2306|225|I|different medication (such as acetaminophen by itself) to treat||
2306|226|I|pain/fever. If you must take this medication, talk to your doctor||
2306|227|I|about taking immediate-release aspirin (not enteric-coated/EC)||
2306|228|I|while taking ibuprofen/acetaminophen. Take this medication at||
2306|229|I|least 8 hours before or at least 2 hours after your aspirin dose.||
2306|230|I|Do not increase your daily dose of aspirin or change the way you||
2306|231|I|take aspirin/other medications without your doctor's approval.||
2306|232|I|   This medication may interfere with certain lab tests, possibly||
2306|233|I|causing false test results. Make sure lab personnel and all your||
2306|234|I|doctors know you use this drug.||
2306|235|B|||
2306|236|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2306|237|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2306|238|O|poison control center right away. US residents can call||
2306|239|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2306|240|O|Symptoms of overdose may include: severe stomach pain, trouble||
2306|241|O|breathing, extreme drowsiness.||
2306|242|B|||
2306|243|N|NOTES:  Keep all medical and lab appointments.||
2306|244|B|||
2306|245|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
2306|246|D|(not just "as needed") and you miss a dose, take it as soon as||
2306|247|D|you remember. If it is near the time of the next dose, skip the||
2306|248|D|missed dose. Take your next dose at the regular time. Do not||
2306|249|D|double the dose to catch up.||
2306|250|B|||
2306|251|R|STORAGE:  Store at room temperature away from light and moisture.||
2306|252|R|Do not store in the bathroom. Keep all medications away from||
2306|253|R|children and pets.||
2306|254|R|   Do not flush medications down the toilet or pour them into a||
2306|255|R|drain unless instructed to do so. Properly discard this product||
2306|256|R|when it is expired or no longer needed. Consult your pharmacist||
2306|257|R|or local waste disposal company.||
2306|258|B|||
2306|259|A|Information last revised November 2025.||
2306|260|A|Copyright(c) 2025 First Databank, Inc.||
2306|261|B|||
2307|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2307|002|Z|does NOT have all possible information about this product. This||
2307|003|Z|information does not assure that this product is safe, effective,||
2307|004|Z|or appropriate for you. This information is not individual||
2307|005|Z|medical advice and does not substitute for the advice of your||
2307|006|Z|health care professional. Always ask your health care||
2307|007|Z|professional for complete information about this product and your||
2307|008|Z|specific health needs.||
2307|009|B|||
2307|010|T|OLICERIDINE - INJECTION||
2307|011|F|(OH-li-SER-i-deen)||
2307|012|B|||
2307|013|C|COMMON BRAND NAME(S): Olinvyk||
2307|014|B|||
2307|015|W|WARNING:  Oliceridine has a risk for abuse and addiction, which||
2307|016|W|can lead to overdose and death. Oliceridine may also cause||
2307|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
2307|018|W|your doctor should have you use the smallest dose of oliceridine||
2307|019|W|that works, and use it for the shortest possible time. See also||
2307|020|W|How to Use section for more information about addiction.||
2307|021|W|   Ask your doctor or pharmacist if you should have medication||
2307|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
2307|023|W|Teach your family or household members about the signs of an||
2307|024|W|opioid overdose and how to treat it.||
2307|025|W|   The risk for severe breathing problems is higher when you||
2307|026|W|start this medication and after a dose increase, or if you use||
2307|027|W|the wrong dose/strength. Using this medication with alcohol or||
2307|028|W|other drugs that can cause drowsiness or breathing problems may||
2307|029|W|cause very serious side effects, including death. Be sure you||
2307|030|W|know how to use oliceridine and what other drugs you should avoid||
2307|031|W|using with it. See also Drug Interactions section. Get medical||
2307|032|W|help right away if any of these very serious side effects occur:||
2307|033|W|slow/shallow breathing, unusual lightheadedness, severe||
2307|034|W|drowsiness/dizziness, difficulty waking up.||
2307|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
2307|036|W|or abuse. If someone accidentally uses or swallows this drug, get||
2307|037|W|medical help right away.||
2307|038|W|   Before using this medication, women of childbearing age should||
2307|039|W|talk with their doctor(s) about the risks and benefits. Tell your||
2307|040|W|doctor if you are pregnant or if you plan to become pregnant.||
2307|041|W|During pregnancy, this medication should be used only when||
2307|042|W|clearly needed. It may slightly increase the risk of birth||
2307|043|W|defects if used during the first two months of pregnancy. Also,||
2307|044|W|using it for a long time or in high doses near the expected||
2307|045|W|delivery date may harm the unborn baby. To lessen the risk, use||
2307|046|W|the smallest effective dose for the shortest possible time.||
2307|047|W|Babies born to mothers who use this drug for a long time may||
2307|048|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
2307|049|W|doctor right away if you notice any symptoms in your newborn baby||
2307|050|W|such as crying that doesn't stop, slow/shallow breathing,||
2307|051|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
2307|052|W|difficulty gaining weight.||
2307|053|B|||
2307|054|U|USES:  This medication is used to treat severe pain. Oliceridine||
2307|055|U|belongs to a class of drugs known as opioid analgesics. It works||
2307|056|U|in the brain to change how your body feels and responds to pain.||
2307|057|B|||
2307|058|H|HOW TO USE:  This medication is given by injection into a vein as||
2307|059|H|directed by your doctor. The dosage is based on your medical||
2307|060|H|condition and response to treatment. Do not increase your dose or||
2307|061|H|use this drug more often or for longer than prescribed, because||
2307|062|H|your risk of side effects may increase. Properly stop the||
2307|063|H|medication when so directed.||
2307|064|H|   Pain medications work best if they are used as the first signs||
2307|065|H|of pain occur. If you wait until the pain has worsened, the||
2307|066|H|medication may not work as well.||
2307|067|H|   Before using, check this product for particles or||
2307|068|H|discoloration. If either is present, do not use the liquid.||
2307|069|H|   Learn how to store and discard medical supplies safely.||
2307|070|H|   If nausea occurs, consult your doctor or pharmacist for ways||
2307|071|H|to decrease it (such as lying down for 1 to 2 hours with as||
2307|072|H|little head movement as possible).||
2307|073|H|   Suddenly stopping this medication may cause withdrawal,||
2307|074|H|especially if you have used it for a long time or in high doses.||
2307|075|H|To prevent withdrawal, your doctor may lower your dose slowly.||
2307|076|H|Tell your doctor or pharmacist right away if you have any||
2307|077|H|withdrawal symptoms such as restlessness, mental/mood changes||
2307|078|H|(including anxiety, trouble sleeping), watering eyes, runny nose,||
2307|079|H|nausea, diarrhea, sweating, muscle aches, or sudden changes in||
2307|080|H|behavior.||
2307|081|H|   When this medication is used for a long time, it may not work||
2307|082|H|as well. Talk with your doctor if this medication stops working||
2307|083|H|well.||
2307|084|H|   Though it helps many people, this medication may sometimes||
2307|085|H|cause addiction. This risk may be higher if you have a||
2307|086|H|mental/mood disorder or a substance use disorder (such as overuse||
2307|087|H|of or addiction to drugs/alcohol). Use this medication exactly as||
2307|088|H|prescribed to lower the risk of addiction. Ask your doctor or||
2307|089|H|pharmacist for more details.||
2307|090|H|   Tell your doctor if your pain does not get better or if it||
2307|091|H|gets worse, or if you have any new pain.||
2307|092|B|||
2307|093|S|SIDE EFFECTS:  See also Warning section.||
2307|094|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
2307|095|S|drowsiness, or headache may occur. If any of these effects last||
2307|096|S|or get worse, tell your doctor or pharmacist promptly.||
2307|097|S|   To prevent constipation, eat dietary fiber, drink enough||
2307|098|S|water, and exercise. You may also need to take a laxative. Ask||
2307|099|S|your pharmacist which type of laxative is right for you.||
2307|100|S|   To reduce the risk of dizziness and lightheadedness, get up||
2307|101|S|slowly when rising from a sitting or lying position.||
2307|102|S|   Remember that this medication has been prescribed because your||
2307|103|S|doctor has judged that the benefit to you is greater than the||
2307|104|S|risk of side effects. Many people using this medication do not||
2307|105|S|have serious side effects.||
2307|106|S|   Tell your doctor right away if you have any serious side||
2307|107|S|effects, including: interrupted breathing during sleep (sleep||
2307|108|S|apnea), mental/mood changes (such as agitation, hallucinations,||
2307|109|S|confusion), difficulty urinating, fast heartbeat, severe||
2307|110|S|stomach/abdominal pain, signs of your adrenal glands not working||
2307|111|S|well (such as loss of appetite, unusual tiredness, weight loss),||
2307|112|S|trouble swallowing.||
2307|113|S|   Get medical help right away if you have any very serious side||
2307|114|S|effects, including: slow/shallow breathing, fainting, severe||
2307|115|S|drowsiness/difficulty waking up, seizures.||
2307|116|S|   A very serious allergic reaction to this drug is rare.||
2307|117|S|However, get medical help right away if you notice any symptoms||
2307|118|S|of a serious allergic reaction, including: rash, itching/swelling||
2307|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2307|120|S|breathing.||
2307|121|S|   This is not a complete list of possible side effects. If you||
2307|122|S|notice other effects not listed above, contact your doctor or||
2307|123|S|pharmacist.||
2307|124|S|   In the US -||
2307|125|S|   Call your doctor for medical advice about side effects. You||
2307|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2307|127|S|www.fda.gov/medwatch.||
2307|128|S|   In Canada - Call your doctor for medical advice about side||
2307|129|S|effects. You may report side effects to Health Canada at||
2307|130|S|1-866-234-2345.||
2307|131|B|||
2307|132|P|PRECAUTIONS:  Before using oliceridine injection, tell your||
2307|133|P|doctor or pharmacist if you are allergic to it; or if you have||
2307|134|P|any other allergies. This product may contain inactive||
2307|135|P|ingredients (such as sulfites found in some brands), which can||
2307|136|P|cause allergic reactions or other problems. Talk to your||
2307|137|P|pharmacist for more details.||
2307|138|P|   Before using this medication, tell your doctor or pharmacist||
2307|139|P|your medical history, especially of: brain disorders (such as||
2307|140|P|head injury, tumor, seizures), breathing problems (such as||
2307|141|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
2307|142|P|gallbladder disease, liver disease, heart problems (such as||
2307|143|P|irregular heartbeat), mental/mood disorders (such as confusion,||
2307|144|P|depression, thoughts of suicide), personal or family history of a||
2307|145|P|substance use disorder (such as overuse of or addiction to||
2307|146|P|drugs/alcohol), stomach/intestinal problems (such as blockage,||
2307|147|P|constipation, diarrhea due to infection, paralytic ileus),||
2307|148|P|disease of the pancreas (pancreatitis), difficulty urinating||
2307|149|P|(such as due to enlarged prostate).||
2307|150|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2307|151|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2307|152|P|machinery, or do anything that needs alertness until you can do||
2307|153|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2307|154|P|are using marijuana (cannabis).||
2307|155|P|   Before having surgery, tell your doctor or dentist about all||
2307|156|P|the products you use (including prescription drugs,||
2307|157|P|nonprescription drugs, and herbal products).||
2307|158|P|   Older adults may be more sensitive to the side effects of this||
2307|159|P|drug, especially confusion, dizziness, drowsiness, and||
2307|160|P|slow/shallow breathing.||
2307|161|P|   During pregnancy, this medication should be used only when||
2307|162|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2307|163|P|benefits with your doctor. (See also Warning section.)||
2307|164|P|   It is unknown if this medication passes into breast milk.||
2307|165|P|Consult your doctor before breastfeeding.||
2307|166|B|||
2307|167|I|DRUG INTERACTIONS:  See also Warning section.||
2307|168|I|   Drug interactions may change how your medications work or||
2307|169|I|increase your risk for serious side effects. This document does||
2307|170|I|not contain all possible drug interactions. Keep a list of all||
2307|171|I|the products you use (including prescription/nonprescription||
2307|172|I|drugs and herbal products) and share it with your doctor and||
2307|173|I|pharmacist. Do not start, stop, or change the dosage of any||
2307|174|I|medicines without your doctor's approval.||
2307|175|I|   Some products that may interact with this drug are: certain||
2307|176|I|pain medications (mixed opioid agonist/antagonists such as||
2307|177|I|butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.||
2307|178|I|   The risk of serious side effects (such as slow/shallow||
2307|179|I|breathing, severe drowsiness/dizziness) may be increased if this||
2307|180|I|medication is used with other products that may also cause||
2307|181|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2307|182|I|if you are taking other products such as other opioid pain or||
2307|183|I|cough relievers (such as codeine, hydrocodone), alcohol,||
2307|184|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
2307|185|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2307|186|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2307|187|I|cetirizine, diphenhydramine).||
2307|188|I|   Check the labels on all your medicines (such as allergy or||
2307|189|I|cough-and-cold products) because they may contain ingredients||
2307|190|I|that cause drowsiness. Ask your pharmacist about using those||
2307|191|I|products safely.||
2307|192|I|   This medication may interfere with certain lab tests (such as||
2307|193|I|amylase/lipase levels), possibly causing false test results. Make||
2307|194|I|sure lab personnel and all your doctors know you use this drug.||
2307|195|B|||
2307|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2307|197|O|as passing out or trouble breathing, give them naloxone or||
2307|198|O|nalmefene if available, then call 911. If the person is awake and||
2307|199|O|has no symptoms, call a poison control center right away. US||
2307|200|O|residents can call 1-800-222-1222. Canada residents can call||
2307|201|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
2307|202|O|breathing, severe drowsiness/dizziness, fast/irregular heartbeat,||
2307|203|O|fainting.||
2307|204|B|||
2307|205|N|NOTES:  Do not share this medication with others. Sharing it is||
2307|206|N|against the law.||
2307|207|N|   This medication has been prescribed for your current condition||
2307|208|N|only. Do not use it later for another condition unless your||
2307|209|N|doctor directs you to do so. A different medication may be||
2307|210|N|necessary in that case.||
2307|211|B|||
2307|212|D|MISSED DOSE:  If you use this medication regularly and miss a||
2307|213|D|dose, use it as soon as you remember. If it is near the time of||
2307|214|D|the next dose, skip the missed dose. Use your next dose at the||
2307|215|D|regular time. Do not double the dose to catch up.||
2307|216|B|||
2307|217|R|STORAGE:  Store at room temperature away from light. Keep all||
2307|218|R|medications away from children and pets.||
2307|219|R|   Do not flush medications down the toilet or pour them into a||
2307|220|R|drain unless instructed to do so. Properly discard this product||
2307|221|R|when it is expired or no longer needed. Consult your pharmacist||
2307|222|R|or local waste disposal company.||
2307|223|B|||
2307|224|A|Information last revised August 2025.||
2307|225|A|Copyright(c) 2025 First Databank, Inc.||
2307|226|B|||
2309|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2309|002|Z|does NOT have all possible information about this product. This||
2309|003|Z|information does not assure that this product is safe, effective,||
2309|004|Z|or appropriate for you. This information is not individual||
2309|005|Z|medical advice and does not substitute for the advice of your||
2309|006|Z|health care professional. Always ask your health care||
2309|007|Z|professional for complete information about this product and your||
2309|008|Z|specific health needs.||
2309|009|B|||
2309|010|T|SODIUM/POTASSIUM/MAGNESIUM TABLET - ORAL||
2309|011|F|(SOE-dee-um/poe-TAS-ee-um/mag-NEE-zee-um)||
2309|012|B|||
2309|013|C|COMMON BRAND NAME(S): Sutab||
2309|014|B|||
2309|015|U|USES:  This product is used to clean out the intestines before a||
2309|016|U|certain bowel exam procedure (colonoscopy). It is a laxative that||
2309|017|U|works by drawing large amounts of water into the colon. This||
2309|018|U|causes watery bowel movements. Clearing stool from the intestines||
2309|019|U|helps your doctor to better examine the intestines during your||
2309|020|U|procedure.||
2309|021|B|||
2309|022|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2309|023|H|provided by your pharmacist before you start using this product||
2309|024|H|and each time you get a refill. If you have any questions, ask||
2309|025|H|your doctor or pharmacist.||
2309|026|H|   Follow any special diet instructions provided by your doctor.||
2309|027|H|Usually, you may have a small breakfast on the day before your||
2309|028|H|procedure. After breakfast, you may only drink clear liquids||
2309|029|H|until after your procedure. Do not drink milk or alcoholic||
2309|030|H|beverages or eat/drink anything colored red or purple. To prevent||
2309|031|H|becoming dehydrated, drink as much clear liquid as you can||
2309|032|H|before, during, and after taking this medication unless otherwise||
2309|033|H|directed by your doctor.||
2309|034|H|   Do not take any other medications by mouth within 1 hour of||
2309|035|H|taking a dose of this product. This product also contains||
2309|036|H|magnesium, which may bind with certain medications (including||
2309|037|H|iron, tetracycline antibiotics, fluoroquinolone antibiotics such||
2309|038|H|as ciprofloxacin), preventing their full absorption. Ask your||
2309|039|H|doctor or pharmacist about rescheduling your other medications||
2309|040|H|while you are taking this product.||
2309|041|H|   Use this product as directed by your doctor, usually one dose||
2309|042|H|the evening before the colonoscopy and the second dose the next||
2309|043|H|day in the morning. This product contains 2 bottles of||
2309|044|H|medication. Each bottle contains one dose of the medication.||
2309|045|H|Before taking your first dose, discard the desiccant (drying||
2309|046|H|agent) found in both of the bottles.||
2309|047|H|   Before taking each dose, fill the provided container with||
2309|048|H|water up to the fill line and use the water to take your dose of||
2309|049|H|the medication. Finish drinking the whole amount of water over 15||
2309|050|H|to 20 minutes. About an hour after taking the dose of your||
2309|051|H|medication, drink another container filled with water over 30||
2309|052|H|minutes. About 30 minutes after finishing your second container||
2309|053|H|of water, drink another container filled with water over 30||
2309|054|H|minutes. Be sure to finish taking your dose of the medication and||
2309|055|H|required water at least 2 hours before your procedure, or as||
2309|056|H|directed.||
2309|057|H|   Ask your doctor or pharmacist if you have any questions about||
2309|058|H|how to take this product or what to expect after taking this||
2309|059|H|product.||
2309|060|H|   If severe bloating, nausea, or abdominal pain occurs, drink||
2309|061|H|the water more slowly or temporarily stop drinking the water||
2309|062|H|until the symptoms improve.||
2309|063|B|||
2309|064|S|SIDE EFFECTS:  Very watery bowel movements are expected with this||
2309|065|S|medication. Nausea, vomiting, bloating, or abdominal||
2309|066|S|cramping/pain may occur. If any of these effects last or get||
2309|067|S|worse, tell your doctor or pharmacist promptly.||
2309|068|S|   Remember that this medication has been prescribed because your||
2309|069|S|doctor has judged that the benefit to you is greater than the||
2309|070|S|risk of side effects. Many people using this medication do not||
2309|071|S|have serious side effects.||
2309|072|S|   This medication can cause dehydration and electrolyte||
2309|073|S|imbalance. Tell your doctor right away if you have any symptoms||
2309|074|S|of dehydration or electrolyte imbalance, including dizziness,||
2309|075|S|fainting, fast/irregular heartbeat, severe vomiting, headache, or||
2309|076|S|seizure.||
2309|077|S|   Tell your doctor right away if you have any serious side||
2309|078|S|effects, including: signs of kidney problems (such as change in||
2309|079|S|the amount of urine), severe stomach/abdominal pain, bloody||
2309|080|S|stools, rectal bleeding.||
2309|081|S|   A very serious allergic reaction to this drug is rare.||
2309|082|S|However, get medical help right away if you notice any symptoms||
2309|083|S|of a serious allergic reaction, including: rash, itching/swelling||
2309|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2309|085|S|breathing.||
2309|086|S|   This is not a complete list of possible side effects. If you||
2309|087|S|notice other effects not listed above, contact your doctor or||
2309|088|S|pharmacist.||
2309|089|S|   In the US -||
2309|090|S|   Call your doctor for medical advice about side effects. You||
2309|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2309|092|S|www.fda.gov/medwatch.||
2309|093|S|   In Canada - Call your doctor for medical advice about side||
2309|094|S|effects. You may report side effects to Health Canada at||
2309|095|S|1-866-234-2345.||
2309|096|B|||
2309|097|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2309|098|P|pharmacist if you have any allergies. This product may contain||
2309|099|P|inactive ingredients, which can cause allergic reactions or other||
2309|100|P|problems. Talk to your pharmacist for more details.||
2309|101|P|   Before using this medication, tell your doctor or pharmacist||
2309|102|P|your medical history, especially of: stomach/intestinal disorders||
2309|103|P|(such as blockage, hole in the intestines, toxic colitis, toxic||
2309|104|P|megacolon, ulcerative colitis, gastric retention, ileus), heart||
2309|105|P|problems (such as irregular heartbeat, chest pain, heart||
2309|106|P|failure), trouble swallowing, kidney problems, mineral||
2309|107|P|imbalances, seizure, regular use of alcohol.||
2309|108|P|   Before having surgery, tell your doctor or dentist about all||
2309|109|P|the products you use (including prescription drugs,||
2309|110|P|nonprescription drugs, and herbal products).||
2309|111|P|   During pregnancy, this medication should be used only when||
2309|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
2309|113|P|   It is unknown if this drug passes into breast milk. Consult||
2309|114|P|your doctor before breastfeeding.||
2309|115|B|||
2309|116|I|DRUG INTERACTIONS:  See also How to Use section.||
2309|117|I|   Drug interactions may change how your medications work or||
2309|118|I|increase your risk for serious side effects. This document does||
2309|119|I|not contain all possible drug interactions. Keep a list of all||
2309|120|I|the products you use (including prescription/nonprescription||
2309|121|I|drugs and herbal products) and share it with your doctor and||
2309|122|I|pharmacist. Do not start, stop, or change the dosage of any||
2309|123|I|medicines without your doctor's approval.||
2309|124|I|   Do not take/use other laxatives while taking this product.||
2309|125|B|||
2309|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2309|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2309|128|O|poison control center right away. US residents can call||
2309|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2309|130|B|||
2309|131|N|NOTES:  Do not share this medication with others.||
2309|132|N|   Lab and/or medical tests (such as kidney function, blood||
2309|133|N|mineral levels) may be done before or after taking this||
2309|134|N|medication. Keep all medical and lab appointments. Consult your||
2309|135|N|doctor for more details.||
2309|136|B|||
2309|137|D|MISSED DOSE:  If you are unable to take this medication or drink||
2309|138|D|all the water as directed, call your doctor right away. Your test||
2309|139|D|may need to be rescheduled.||
2309|140|B|||
2309|141|R|STORAGE:  Store at room temperature away from light and moisture.||
2309|142|R|Do not store in the bathroom. Keep all medications away from||
2309|143|R|children and pets.||
2309|144|R|   Do not flush medications down the toilet or pour them into a||
2309|145|R|drain unless instructed to do so. Properly discard this product||
2309|146|R|when it is expired or no longer needed. Consult your pharmacist||
2309|147|R|or local waste disposal company.||
2309|148|B|||
2309|149|A|Information last revised May 2024.||
2309|150|A|Copyright(c) 2025 First Databank, Inc.||
2309|151|B|||
2311|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2311|002|Z|does NOT have all possible information about this product. This||
2311|003|Z|information does not assure that this product is safe, effective,||
2311|004|Z|or appropriate for you. This information is not individual||
2311|005|Z|medical advice and does not substitute for the advice of your||
2311|006|Z|health care professional. Always ask your health care||
2311|007|Z|professional for complete information about this product and your||
2311|008|Z|specific health needs.||
2311|009|B|||
2311|010|T|PEPPERMINT OIL - ORAL||
2311|011|B|||
2311|012|U|USES:  Peppermint oil has been used for stomach/intestinal||
2311|013|U|disorders (such as upset stomach, cramps, irritable bowel||
2311|014|U|syndrome-IBS).||
2311|015|U|   This product should not be used by children younger than 8||
2311|016|U|years.||
2311|017|U|   Some herbal/diet supplement products have been found to||
2311|018|U|contain possibly harmful impurities/additives. Check with your||
2311|019|U|pharmacist for more details about the brand you use.||
2311|020|U|   The FDA has not reviewed this product for safety or||
2311|021|U|effectiveness. Consult your doctor or pharmacist for more||
2311|022|U|details.||
2311|023|B|||
2311|024|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
2311|025|H|directions and warnings on the product package. If you have any||
2311|026|H|questions, ask your doctor or pharmacist.||
2311|027|H|   If you are using the capsule form of this product, swallow the||
2311|028|H|capsules whole. Do not crush or chew the capsules. Doing so can||
2311|029|H|release all of the drug at once, increasing the risk of side||
2311|030|H|effects. If you are unable to swallow the capsules, you may open||
2311|031|H|the capsule of some brands and sprinkle the contents onto a||
2311|032|H|spoonful of cool, soft applesauce. Swallow all of the mixture||
2311|033|H|right away without chewing.||
2311|034|H|   If your condition lasts or gets worse, or if you think you may||
2311|035|H|have a serious medical problem, get medical help right away.||
2311|036|B|||
2311|037|S|SIDE EFFECTS:  Nausea, vomiting, or heartburn may occur. If any||
2311|038|S|of these effects last or get worse, tell your doctor or||
2311|039|S|pharmacist promptly.||
2311|040|S|   Tell your doctor right away if you have any serious side||
2311|041|S|effects, including: headache, flushing, mouth irritation/sores,||
2311|042|S|severe stomach/abdominal pain.||
2311|043|S|   A very serious allergic reaction to this product is rare.||
2311|044|S|However, get medical help right away if you notice any symptoms||
2311|045|S|of a serious allergic reaction, including: rash, itching/swelling||
2311|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2311|047|S|breathing.||
2311|048|S|   This is not a complete list of possible side effects. If you||
2311|049|S|notice other effects not listed above, contact your doctor or||
2311|050|S|pharmacist.||
2311|051|S|   In the US -||
2311|052|S|   Call your doctor for medical advice about side effects. You||
2311|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2311|054|S|www.fda.gov/medwatch.||
2311|055|S|   In Canada - Call your doctor for medical advice about side||
2311|056|S|effects. You may report side effects to Health Canada at||
2311|057|S|1-866-234-2345.||
2311|058|B|||
2311|059|P|PRECAUTIONS:  Before taking peppermint oil, tell your doctor or||
2311|060|P|pharmacist if you are allergic to it; or if you have any other||
2311|061|P|allergies. This product may contain inactive ingredients, which||
2311|062|P|can cause allergic reactions or other problems. Talk to your||
2311|063|P|pharmacist for more details.||
2311|064|P|   If you have any of the following health problems, consult your||
2311|065|P|doctor or pharmacist before using this product: heartburn||
2311|066|P|(gastroesophageal reflux disease-GERD), stomach/intestinal||
2311|067|P|ulcers, liver disease, gallbladder disease, bile duct blockage.||
2311|068|P|   Liquid forms of this product may contain sugar and/or alcohol.||
2311|069|P|Caution is advised if you have diabetes, alcohol dependence, or||
2311|070|P|liver disease. Ask your doctor or pharmacist about using this||
2311|071|P|product safely.||
2311|072|P|   Before having surgery, tell your doctor or dentist about all||
2311|073|P|the products you use (including prescription drugs,||
2311|074|P|nonprescription drugs, and herbal products).||
2311|075|P|   This product is not recommended for use during pregnancy.||
2311|076|P|Consult your doctor for more details.||
2311|077|P|   It is unknown if this product passes into breast milk. Consult||
2311|078|P|your doctor before breastfeeding.||
2311|079|B|||
2311|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2311|081|I|medications work or increase your risk for serious side effects.||
2311|082|I|This document does not contain all possible drug interactions.||
2311|083|I|Keep a list of all the products you use (including||
2311|084|I|prescription/nonprescription drugs and herbal products) and share||
2311|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
2311|086|I|the dosage of any medicines without your doctor's approval.||
2311|087|B|||
2311|088|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2311|089|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2311|090|O|poison control center right away. US residents can call||
2311|091|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2311|092|B|||
2311|093|N|NOTES:  Keep all medical and lab appointments.||
2311|094|B|||
2311|095|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2311|096|D|remember. If it is near the time of the next dose, skip the||
2311|097|D|missed dose. Take your next dose at the regular time. Do not||
2311|098|D|double the dose to catch up.||
2311|099|B|||
2311|100|R|STORAGE:  Refer to storage information printed on the package. If||
2311|101|R|you have any questions about storage, ask your pharmacist. Keep||
2311|102|R|all medications and herbal products away from children and pets.||
2311|103|R|   Do not flush medications down the toilet or pour them into a||
2311|104|R|drain unless instructed to do so. Properly discard this product||
2311|105|R|when it is expired or no longer needed. Consult your pharmacist||
2311|106|R|or local waste disposal company.||
2311|107|B|||
2311|108|A|Information last revised May 2024.||
2311|109|A|Copyright(c) 2025 First Databank, Inc.||
2311|110|B|||
2313|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2313|002|Z|does NOT have all possible information about this product. This||
2313|003|Z|information does not assure that this product is safe, effective,||
2313|004|Z|or appropriate for you. This information is not individual||
2313|005|Z|medical advice and does not substitute for the advice of your||
2313|006|Z|health care professional. Always ask your health care||
2313|007|Z|professional for complete information about this product and your||
2313|008|Z|specific health needs.||
2313|009|B|||
2313|010|T|ST. JOHN'S WORT (Hypericum perforatum) - ORAL||
2313|011|B|||
2313|012|U|USES:  St. John's wort has been used for depression.||
2313|013|U|   Some herbal/dietary supplement products have been found to||
2313|014|U|contain possibly harmful impurities/additives. Check with your||
2313|015|U|pharmacist for more details about the brand you use.||
2313|016|U|   The FDA has not reviewed this product for safety or||
2313|017|U|effectiveness. Consult your doctor or pharmacist for more||
2313|018|U|details.||
2313|019|B|||
2313|020|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
2313|021|H|directions on the product package. If you have any questions, ask||
2313|022|H|your doctor or pharmacist. Do not take more than the recommended||
2313|023|H|amount. It may take about 3 weeks of regular use before you||
2313|024|H|notice the benefits of this product.||
2313|025|H|   Do not suddenly stop taking this product. Some conditions may||
2313|026|H|become worse when this product is abruptly stopped. You may need||
2313|027|H|to gradually reduce your dose. Consult your doctor or pharmacist||
2313|028|H|for details.||
2313|029|H|   If your condition lasts or gets worse, or if you think you may||
2313|030|H|have a serious medical problem, get medical help right away.||
2313|031|B|||
2313|032|S|SIDE EFFECTS:  Trouble sleeping, restlessness, upset stomach,||
2313|033|S|dizziness, headache, or numbness/tingling of the hands/feet may||
2313|034|S|occur. If any of these effects last or get worse, contact your||
2313|035|S|doctor or pharmacist promptly.||
2313|036|S|   Tell your doctor right away if you have any serious side||
2313|037|S|effects, including: black/bloody/tarry stools, vomit that looks||
2313|038|S|like coffee grounds, easy bruising/bleeding.||
2313|039|S|   This product may increase serotonin and rarely cause a very||
2313|040|S|serious condition called serotonin syndrome/toxicity. The risk||
2313|041|S|increases if you are also taking other drugs that increase||
2313|042|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2313|043|S|take (see Drug Interactions section). Get medical help right away||
2313|044|S|if you develop some of the following symptoms: fast heartbeat,||
2313|045|S|hallucinations, loss of coordination, severe dizziness, severe||
2313|046|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2313|047|S|unusual agitation/restlessness.||
2313|048|S|   A very serious allergic reaction to this product is rare.||
2313|049|S|However, get medical help right away if you notice any symptoms||
2313|050|S|of a serious allergic reaction, including: rash, itching/swelling||
2313|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2313|052|S|breathing.||
2313|053|S|   This is not a complete list of possible side effects. If you||
2313|054|S|notice other effects not listed above, contact your doctor or||
2313|055|S|pharmacist.||
2313|056|S|   In the US -||
2313|057|S|   Call your doctor for medical advice about side effects. You||
2313|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2313|059|S|www.fda.gov/medwatch.||
2313|060|S|   In Canada - Call your doctor for medical advice about side||
2313|061|S|effects. You may report side effects to Health Canada at||
2313|062|S|1-866-234-2345.||
2313|063|B|||
2313|064|P|PRECAUTIONS:  Before taking St. John's wort, tell your doctor or||
2313|065|P|pharmacist if you are allergic to it; or if you have any other||
2313|066|P|allergies. This product may contain inactive ingredients, which||
2313|067|P|can cause allergic reactions or other problems. Talk to your||
2313|068|P|pharmacist for more details.||
2313|069|P|   If you have any of the following health problems, consult your||
2313|070|P|doctor or pharmacist before using this product: personal or||
2313|071|P|family history of bipolar/manic-depressive disorder.||
2313|072|P|   This product may make you more sensitive to the sun. Limit||
2313|073|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2313|074|P|sunscreen and wear protective clothing when outdoors. Tell your||
2313|075|P|doctor right away if you get sunburned or have skin||
2313|076|P|blisters/redness.||
2313|077|P|   Liquid forms of this product may contain sugar and/or alcohol.||
2313|078|P|Caution is advised if you have diabetes, alcohol dependence, or||
2313|079|P|liver disease. Ask your doctor or pharmacist about using this||
2313|080|P|product safely.||
2313|081|P|   Before having surgery, tell your doctor or dentist about all||
2313|082|P|the products you use (including prescription drugs,||
2313|083|P|nonprescription drugs, and herbal products).||
2313|084|P|   St. John's wort is not recommended for use during pregnancy.||
2313|085|P|Consult your doctor before using this product.||
2313|086|P|   It is unknown if St. John's wort passes into breast milk.||
2313|087|P|Consult your doctor before breastfeeding.||
2313|088|B|||
2313|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2313|090|I|medications work or increase your risk for serious side effects.||
2313|091|I|This document does not contain all possible drug interactions.||
2313|092|I|Keep a list of all the products you use (including||
2313|093|I|prescription/nonprescription drugs and herbal products) and share||
2313|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
2313|095|I|the dosage of any medicines without your doctor's approval.||
2313|096|I|   St. John's wort can interact with many medications and||
2313|097|I|products.||
2313|098|I|   Some drugs that may interact with this product are: drugs that||
2313|099|I|can cause bleeding/bruising (including antiplatelet drugs such as||
2313|100|I|clopidogrel, "blood thinners" such as warfarin and heparin,||
2313|101|I|NSAIDs such as ibuprofen).||
2313|102|I|   This product can speed up the removal of other drugs from your||
2313|103|I|body, which may affect how they work. Examples of affected drugs||
2313|104|I|include certain azole antifungals (such as isavuconazonium,||
2313|105|I|voriconazole), certain drugs used to treat cancer (such as||
2313|106|I|irinotecan, sunitinib, tamoxifen), cobicistat, nifedipine, HIV||
2313|107|I|NNRTIs (such as etravirine, nevirapine), HIV protease inhibitors||
2313|108|I|(such as atazanavir, darunavir), ritonavir, among others.||
2313|109|I|   Taking MAO inhibitors with this medication may cause a serious||
2313|110|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2313|111|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2313|112|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2313|113|I|selegiline, tranylcypromine) during treatment with this||
2313|114|I|medication. Most MAO inhibitors should also not be taken for two||
2313|115|I|weeks before treatment with this medication. Ask your doctor when||
2313|116|I|to start or stop taking this medication.||
2313|117|I|   The risk of serotonin syndrome/toxicity increases if you are||
2313|118|I|also taking other drugs that increase serotonin. Examples include||
2313|119|I|street drugs such as MDMA/"ecstasy," certain antidepressants||
2313|120|I|(including SSRIs such as fluoxetine/paroxetine, SNRIs such as||
2313|121|I|duloxetine/venlafaxine), among others. The risk of serotonin||
2313|122|I|syndrome/toxicity may be more likely when you start or increase||
2313|123|I|the dose of these drugs.||
2313|124|I|   Aspirin can increase the risk of bleeding when used with this||
2313|125|I|product. If your doctor has told you to take low-dose aspirin to||
2313|126|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
2313|127|I|you should keep taking the aspirin unless your doctor tells you||
2313|128|I|not to. Ask your doctor or pharmacist for more details.||
2313|129|I|   This product may decrease the effectiveness of hormonal birth||
2313|130|I|control such as pills, patch, or ring. This could cause||
2313|131|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2313|132|I|use reliable backup birth control methods while using this||
2313|133|I|product. Also tell your doctor if you have any new spotting or||
2313|134|I|breakthrough bleeding, because these may be signs that your birth||
2313|135|I|control is not working well.||
2313|136|B|||
2313|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2313|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2313|139|O|poison control center right away. US residents can call||
2313|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2313|141|B|||
2313|142|N|NOTES:  Keep all medical and lab appointments.||
2313|143|N|   Check the product labeling carefully to make sure you have the||
2313|144|N|correct product. St. John's wort is a species called Hypericum||
2313|145|N|perforatum and should not be confused with other Hypericum||
2313|146|N|species.||
2313|147|B|||
2313|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2313|149|D|remember. If it is near the time of the next dose, skip the||
2313|150|D|missed dose. Take your next dose at the regular time. Do not||
2313|151|D|double the dose to catch up.||
2313|152|B|||
2313|153|R|STORAGE:  Refer to storage information printed on the package. If||
2313|154|R|you have any questions about storage, ask your pharmacist. Keep||
2313|155|R|all medications and herbal products away from children and pets.||
2313|156|R|   Do not flush medications down the toilet or pour them into a||
2313|157|R|drain unless instructed to do so. Properly discard this product||
2313|158|R|when it is expired or no longer needed. Consult your pharmacist||
2313|159|R|or local waste disposal company.||
2313|160|B|||
2313|161|A|Information last revised May 2024.||
2313|162|A|Copyright(c) 2025 First Databank, Inc.||
2313|163|B|||
2316|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2316|002|Z|does NOT have all possible information about this product. This||
2316|003|Z|information does not assure that this product is safe, effective,||
2316|004|Z|or appropriate for you. This information is not individual||
2316|005|Z|medical advice and does not substitute for the advice of your||
2316|006|Z|health care professional. Always ask your health care||
2316|007|Z|professional for complete information about this product and your||
2316|008|Z|specific health needs.||
2316|009|B|||
2316|010|T|METHYLSULFONYLMETHANE (MSM) - ORAL||
2316|011|B|||
2316|012|U|USES:  Methylsulfonylmethane (MSM) has been used for pain and||
2316|013|U|swelling of the joints caused by osteoarthritis.||
2316|014|U|   Some herbal/dietary supplement products have been found to||
2316|015|U|contain possibly harmful impurities/additives. Check with your||
2316|016|U|pharmacist for more details about the brand you use.||
2316|017|U|   The FDA has not reviewed this product for safety or||
2316|018|U|effectiveness. Consult your doctor or pharmacist for more||
2316|019|U|details.||
2316|020|B|||
2316|021|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
2316|022|H|directions on the product package. If you have any questions, ask||
2316|023|H|your doctor or pharmacist.||
2316|024|H|   If your condition lasts or gets worse, or if you think you may||
2316|025|H|have a serious medical problem, get medical help right away.||
2316|026|B|||
2316|027|S|SIDE EFFECTS:  Upset stomach, headache, or worsening of allergy||
2316|028|S|symptoms may occur. If any of these effects last or get worse,||
2316|029|S|tell your doctor or pharmacist promptly.||
2316|030|S|   A very serious allergic reaction to this product is rare.||
2316|031|S|However, get medical help right away if you notice any symptoms||
2316|032|S|of a serious allergic reaction, including: rash, itching/swelling||
2316|033|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2316|034|S|breathing.||
2316|035|S|   This is not a complete list of possible side effects. If you||
2316|036|S|notice other effects not listed above, contact your doctor or||
2316|037|S|pharmacist.||
2316|038|S|   In the US -||
2316|039|S|   Call your doctor for medical advice about side effects. You||
2316|040|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2316|041|S|www.fda.gov/medwatch.||
2316|042|S|   In Canada - Call your doctor for medical advice about side||
2316|043|S|effects. You may report side effects to Health Canada at||
2316|044|S|1-866-234-2345.||
2316|045|B|||
2316|046|P|PRECAUTIONS:  Before taking methylsulfonylmethane, tell your||
2316|047|P|doctor or pharmacist if you are allergic to it; or if you have||
2316|048|P|any other allergies. This product may contain inactive||
2316|049|P|ingredients, which can cause allergic reactions or other||
2316|050|P|problems. Talk to your pharmacist for more details.||
2316|051|P|   Liquid products may contain sugar and/or alcohol. Caution is||
2316|052|P|advised if you have diabetes, alcohol dependence, or liver||
2316|053|P|disease. Ask your doctor or pharmacist about using this product||
2316|054|P|safely.||
2316|055|P|   During pregnancy, this product should be used only when||
2316|056|P|clearly needed. Discuss the risks and benefits with your doctor.||
2316|057|P|   It is unknown if this medication passes into breast milk.||
2316|058|P|Consult your doctor before breastfeeding.||
2316|059|B|||
2316|060|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2316|061|I|medications work or increase your risk for serious side effects.||
2316|062|I|This document does not contain all possible drug interactions.||
2316|063|I|Keep a list of all the products you use (including||
2316|064|I|prescription/nonprescription drugs and herbal products) and share||
2316|065|I|it with your doctor and pharmacist. Do not start, stop, or change||
2316|066|I|the dosage of any medicines without your doctor's approval.||
2316|067|B|||
2316|068|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2316|069|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2316|070|O|poison control center right away. US residents can call||
2316|071|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2316|072|B|||
2316|073|N|NOTES:  Keep all medical and lab appointments.||
2316|074|B|||
2316|075|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2316|076|D|remember. If it is near the time of the next dose, skip the||
2316|077|D|missed dose. Take your next dose at the regular time. Do not||
2316|078|D|double the dose to catch up.||
2316|079|B|||
2316|080|R|STORAGE:  Refer to storage information printed on the package. If||
2316|081|R|you have any questions about storage, ask your pharmacist. Keep||
2316|082|R|all medications and herbal products away from children and pets.||
2316|083|R|   Do not flush medications down the toilet or pour them into a||
2316|084|R|drain unless instructed to do so. Properly discard this product||
2316|085|R|when it is expired or no longer needed. Consult your pharmacist||
2316|086|R|or local waste disposal company.||
2316|087|B|||
2316|088|A|Information last revised May 2024.||
2316|089|A|Copyright(c) 2025 First Databank, Inc.||
2316|090|B|||
2317|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2317|002|Z|does NOT have all possible information about this product. This||
2317|003|Z|information does not assure that this product is safe, effective,||
2317|004|Z|or appropriate for you. This information is not individual||
2317|005|Z|medical advice and does not substitute for the advice of your||
2317|006|Z|health care professional. Always ask your health care||
2317|007|Z|professional for complete information about this product and your||
2317|008|Z|specific health needs.||
2317|009|B|||
2317|010|T|LOTEPREDNOL 0.25% SUSPENSION - OPHTHALMIC||
2317|011|F|(LOE-te-PRED-nol)||
2317|012|B|||
2317|013|C|COMMON BRAND NAME(S): Eysuvis||
2317|014|B|||
2317|015|U|USES:  This medication is used for short-term (up to 2 weeks)||
2317|016|U|treatment to help relieve dry eye disease. Loteprednol belongs to||
2317|017|U|a class of drugs known as corticosteroids. It works by decreasing||
2317|018|U|inflammation (swelling).||
2317|019|B|||
2317|020|H|HOW TO USE:  Read the Instructions for Use leaflet if available||
2317|021|H|from your pharmacist before you start using loteprednol and each||
2317|022|H|time you get a refill. If you have any questions, ask your doctor||
2317|023|H|or pharmacist.||
2317|024|H|   Use this medication in the affected eye(s) as directed by your||
2317|025|H|doctor, usually 4 times a day for up to 2 weeks.||
2317|026|H|   To apply eye drops, wash hands first. Shake the bottle well||
2317|027|H|for 2 to 3 seconds before using. To avoid contamination, do not||
2317|028|H|touch the dropper tip or let it touch your eye or any other||
2317|029|H|surface.||
2317|030|H|   If you are wearing contact lenses, remove them before using||
2317|031|H|this medication. Wait at least 15 minutes before replacing your||
2317|032|H|contact lenses. Tilt your head back, look upward, and pull down||
2317|033|H|the lower eyelid to make a pouch. Hold the dropper directly over||
2317|034|H|your eye and place one drop into the pouch. Look downward, gently||
2317|035|H|close your eyes, and place one finger at the corner of your eye||
2317|036|H|(near the nose). Apply gentle pressure for 1 to 2 minutes before||
2317|037|H|opening your eyes. This will prevent the medication from draining||
2317|038|H|out. Try not to blink or rub your eye. Repeat these steps if your||
2317|039|H|dose is for more than one drop. If directed to use this||
2317|040|H|medication in both eyes, repeat these steps for your other eye.||
2317|041|H|Do not rinse the dropper. Replace the dropper cap after each use.||
2317|042|H|   If you are using another kind of eye medication (such as other||
2317|043|H|drops or ointments), wait at least 5 minutes before applying||
2317|044|H|other medications. Use eye drops before eye ointments to allow||
2317|045|H|the drops to enter the eye.||
2317|046|H|   Use this medication regularly to get the most benefit from it.||
2317|047|H|To help you remember, use it at the same times each day.||
2317|048|H|   The dosage and length of treatment are based on your medical||
2317|049|H|condition and response to treatment. Do not use this medication||
2317|050|H|more often or for longer than prescribed because doing so may||
2317|051|H|increase your risk of side effects.||
2317|052|H|   Wait several minutes for your vision to clear before driving||
2317|053|H|or operating machinery.||
2317|054|H|   Do not use this product if it becomes contaminated (for||
2317|055|H|example, drops turn a dark color). Use of contaminated eye||
2317|056|H|medication can cause infection, serious damage to the eye, and||
2317|057|H|loss of vision. Contact your doctor or pharmacist for more||
2317|058|H|information.||
2317|059|H|   Tell your doctor if your condition does not get better or if||
2317|060|H|it gets worse.||
2317|061|B|||
2317|062|S|SIDE EFFECTS:  Stinging/burning of the eyes and temporary blurred||
2317|063|S|vision may occur when you apply this medication. If any of these||
2317|064|S|effects last or get worse, tell your doctor or pharmacist||
2317|065|S|promptly.||
2317|066|S|   Remember that this medication has been prescribed because your||
2317|067|S|doctor has judged that the benefit to you is greater than the||
2317|068|S|risk of side effects. Many people using this medication do not||
2317|069|S|have serious side effects.||
2317|070|S|   Use of this medication for a longer time may cause serious eye||
2317|071|S|problems (such as high pressure inside the eyes, cataracts). It||
2317|072|S|may also mask signs of an eye infection and increase the risk of||
2317|073|S|developing an eye infection. Tell your doctor right away if you||
2317|074|S|have any serious side effects, including: vision problems, eye||
2317|075|S|pain, eye discharge/swelling/redness.||
2317|076|S|   A very serious allergic reaction to this drug is rare.||
2317|077|S|However, get medical help right away if you notice any symptoms||
2317|078|S|of a serious allergic reaction, including: rash, itching/swelling||
2317|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2317|080|S|breathing.||
2317|081|S|   This is not a complete list of possible side effects. If you||
2317|082|S|notice other effects not listed above, contact your doctor or||
2317|083|S|pharmacist.||
2317|084|S|   In the US -||
2317|085|S|   Call your doctor for medical advice about side effects. You||
2317|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2317|087|S|www.fda.gov/medwatch.||
2317|088|S|   In Canada - Call your doctor for medical advice about side||
2317|089|S|effects. You may report side effects to Health Canada at||
2317|090|S|1-866-234-2345.||
2317|091|B|||
2317|092|P|PRECAUTIONS:  Before using loteprednol, tell your doctor or||
2317|093|P|pharmacist if you are allergic to it; or if you have any other||
2317|094|P|allergies. This product may contain inactive ingredients, which||
2317|095|P|can cause allergic reactions or other problems. Talk to your||
2317|096|P|pharmacist for more details.||
2317|097|P|   Before using this medication, tell your doctor or pharmacist||
2317|098|P|your medical history, especially of: eye infections, recent eye||
2317|099|P|surgery, cataracts, glaucoma (open-angle type).||
2317|100|P|   After you apply this drug, your vision may become temporarily||
2317|101|P|blurred. Do not drive, use machinery, or do anything that needs||
2317|102|P|clear vision until you can do it safely.||
2317|103|P|   Before having surgery, tell your doctor or dentist about all||
2317|104|P|the products you use (including prescription drugs,||
2317|105|P|nonprescription drugs, and herbal products).||
2317|106|P|   During pregnancy, this medication should be used only when||
2317|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
2317|108|P|   It is unknown if this drug passes into breast milk. Consult||
2317|109|P|your doctor before breastfeeding.||
2317|110|B|||
2317|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2317|112|I|medications work or increase your risk for serious side effects.||
2317|113|I|This document does not contain all possible drug interactions.||
2317|114|I|Keep a list of all the products you use (including||
2317|115|I|prescription/nonprescription drugs and herbal products) and share||
2317|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
2317|117|I|the dosage of any medicines without your doctor's approval.||
2317|118|B|||
2317|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2317|120|O|has overdosed and has serious symptoms such as passing out or||
2317|121|O|trouble breathing, call 911. Otherwise, call a poison control||
2317|122|O|center right away. US residents can call 1-800-222-1222. Canada||
2317|123|O|residents can call 1-844-764-7669.||
2317|124|B|||
2317|125|N|NOTES:  Do not share this medication with others.||
2317|126|N|   This medication has been prescribed for your current condition||
2317|127|N|only. Do not use it later for another eye condition unless your||
2317|128|N|doctor tells you to.||
2317|129|N|   Lab and/or medical tests (such as eye exams) should be done||
2317|130|N|while you are using this medication. Keep all medical and lab||
2317|131|N|appointments.||
2317|132|B|||
2317|133|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2317|134|D|If it is near the time of the next dose, skip the missed dose.||
2317|135|D|Use your next dose at the regular time. Do not double the dose to||
2317|136|D|catch up.||
2317|137|B|||
2317|138|R|STORAGE:  Store upright at room temperature. Do not freeze. Keep||
2317|139|R|all medications away from children and pets.||
2317|140|R|   Do not flush medications down the toilet or pour them into a||
2317|141|R|drain unless instructed to do so. Properly discard this product||
2317|142|R|when it is expired or no longer needed. Consult your pharmacist||
2317|143|R|or local waste disposal company.||
2317|144|B|||
2317|145|A|Information last revised September 2024.||
2317|146|A|Copyright(c) 2025 First Databank, Inc.||
2317|147|B|||
2319|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2319|002|Z|does NOT have all possible information about this product. This||
2319|003|Z|information does not assure that this product is safe, effective,||
2319|004|Z|or appropriate for you. This information is not individual||
2319|005|Z|medical advice and does not substitute for the advice of your||
2319|006|Z|health care professional. Always ask your health care||
2319|007|Z|professional for complete information about this product and your||
2319|008|Z|specific health needs.||
2319|009|B|||
2319|010|T|CLASCOTERONE - TOPICAL||
2319|011|F|(klas-KOE-ter-one)||
2319|012|B|||
2319|013|C|COMMON BRAND NAME(S): Winlevi||
2319|014|B|||
2319|015|U|USES:  This medication is used to treat acne. It helps to||
2319|016|U|decrease the number of acne lesions.||
2319|017|B|||
2319|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2319|019|H|from your pharmacist before you start using clascoterone and each||
2319|020|H|time you get a refill. If you have any questions, ask your doctor||
2319|021|H|or pharmacist.||
2319|022|H|   Use this medication only on the skin. Before applying the||
2319|023|H|medication, clean and dry the affected area. Apply a thin film of||
2319|024|H|the medication to the affected area as directed by your doctor,||
2319|025|H|usually twice a day (once in the morning and once in the||
2319|026|H|evening). Do not apply this medication on any cuts, wounds,||
2319|027|H|sunburned skin, or skin with eczema. Wash your hands after use.||
2319|028|H|   Avoid getting this medication in your eyes, nose, mouth, or||
2319|029|H|vagina. If you get this medication in those areas, rinse with||
2319|030|H|plenty of water.||
2319|031|H|   Do not use this drug more often or for longer than prescribed.||
2319|032|H|Your condition will not improve any faster, and your risk of side||
2319|033|H|effects will increase. Do not cover, bandage or wrap the area||
2319|034|H|unless directed to do so by your doctor.||
2319|035|H|   Avoid using this product along with other skin products that||
2319|036|H|may irritate or dry the skin (such as medicated soaps/cleansers,||
2319|037|H|products that contain alcohol).||
2319|038|H|   Tell your doctor if your condition does not get better or if||
2319|039|H|it gets worse.||
2319|040|B|||
2319|041|S|SIDE EFFECTS:  Redness, itching, peeling, or dryness of the skin||
2319|042|S|may occur. If any of these effects last or get worse, tell your||
2319|043|S|doctor or pharmacist promptly.||
2319|044|S|   Remember that this medication has been prescribed because your||
2319|045|S|doctor has judged that the benefit to you is greater than the||
2319|046|S|risk of side effects. Many people using this medication do not||
2319|047|S|have serious side effects.||
2319|048|S|   Rarely, it is possible this medication may be absorbed from||
2319|049|S|the skin into the bloodstream. This can lead to side effects of||
2319|050|S|too little corticosteroid and androgen hormones. These side||
2319|051|S|effects are more likely in children, and in people who use this||
2319|052|S|medication for a long time or over large areas of the skin. Tell||
2319|053|S|your doctor right away if you have any serious side effects,||
2319|054|S|including: unusual/extreme tiredness, weight loss.||
2319|055|S|   A very serious allergic reaction to this drug is rare.||
2319|056|S|However, get medical help right away if you notice any symptoms||
2319|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2319|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2319|059|S|breathing.||
2319|060|S|   This is not a complete list of possible side effects. If you||
2319|061|S|notice other effects not listed above, contact your doctor or||
2319|062|S|pharmacist.||
2319|063|S|   In the US -||
2319|064|S|   Call your doctor for medical advice about side effects. You||
2319|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2319|066|S|www.fda.gov/medwatch.||
2319|067|S|   In Canada - Call your doctor for medical advice about side||
2319|068|S|effects. You may report side effects to Health Canada at||
2319|069|S|1-866-234-2345.||
2319|070|B|||
2319|071|P|PRECAUTIONS:  Before using clascoterone, tell your doctor or||
2319|072|P|pharmacist if you are allergic to it; or if you have any other||
2319|073|P|allergies. This product may contain inactive ingredients, which||
2319|074|P|can cause allergic reactions or other problems. Talk to your||
2319|075|P|pharmacist for more details.||
2319|076|P|   Before using this medication, tell your doctor or pharmacist||
2319|077|P|your medical history.||
2319|078|P|   Before having surgery, tell your doctor or dentist about all||
2319|079|P|the products you use (including prescription drugs,||
2319|080|P|nonprescription drugs, and herbal products).||
2319|081|P|   During pregnancy, this medication should be used only when||
2319|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
2319|083|P|   It is unknown if this drug passes into breast milk. Consult||
2319|084|P|your doctor before breastfeeding.||
2319|085|B|||
2319|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2319|087|I|medications work or increase your risk for serious side effects.||
2319|088|I|This document does not contain all possible drug interactions.||
2319|089|I|Keep a list of all the products you use (including||
2319|090|I|prescription/nonprescription drugs and herbal products) and share||
2319|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2319|092|I|the dosage of any medicines without your doctor's approval.||
2319|093|B|||
2319|094|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2319|095|O|has overdosed and has serious symptoms such as passing out or||
2319|096|O|trouble breathing, call 911. Otherwise, call a poison control||
2319|097|O|center right away. US residents can call 1-800-222-1222. Canada||
2319|098|O|residents can call 1-844-764-7669.||
2319|099|B|||
2319|100|N|NOTES:  Do not share this medication with others.||
2319|101|B|||
2319|102|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2319|103|D|If it is near the time of the next dose, skip the missed dose.||
2319|104|D|Use your next dose at the regular time. Do not double the dose to||
2319|105|D|catch up.||
2319|106|B|||
2319|107|R|STORAGE:  Store at room temperature. Do not freeze. Different||
2319|108|R|brands of this medication have different storage needs. Check the||
2319|109|R|product package for instructions on how to store your brand, or||
2319|110|R|ask your pharmacist. Keep all medications away from children and||
2319|111|R|pets.||
2319|112|R|   Do not flush medications down the toilet or pour them into a||
2319|113|R|drain unless instructed to do so. Properly discard this product||
2319|114|R|when it is expired or no longer needed. Consult your pharmacist||
2319|115|R|or local waste disposal company.||
2319|116|B|||
2319|117|A|Information last revised May 2024.||
2319|118|A|Copyright(c) 2025 First Databank, Inc.||
2319|119|B|||
2321|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2321|002|Z|does NOT have all possible information about this product. This||
2321|003|Z|information does not assure that this product is safe, effective,||
2321|004|Z|or appropriate for you. This information is not individual||
2321|005|Z|medical advice and does not substitute for the advice of your||
2321|006|Z|health care professional. Always ask your health care||
2321|007|Z|professional for complete information about this product and your||
2321|008|Z|specific health needs.||
2321|009|B|||
2321|010|T|BEROTRALSTAT - ORAL||
2321|011|F|(BER-oh-TRAL-stat)||
2321|012|B|||
2321|013|C|COMMON BRAND NAME(S): Orladeyo||
2321|014|B|||
2321|015|U|USES:  This medication is used to help prevent severe swelling||
2321|016|U|attacks due to a certain inherited immune disease (hereditary||
2321|017|U|angioedema-HAE). Berotralstat works by binding to a natural||
2321|018|U|substance made by the body (kallikrein) and blocking its effect.||
2321|019|U|This blocking effect lowers the amount of another natural||
2321|020|U|substance (bradykinin) that causes symptoms during an attack of||
2321|021|U|HAE.||
2321|022|U|   Berotralstat should not be used to treat an acute HAE attack.||
2321|023|U|If an HAE attack occurs, use your usual rescue medication as||
2321|024|U|prescribed.||
2321|025|B|||
2321|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2321|027|H|from your pharmacist before you start using berotralstat and each||
2321|028|H|time you get a refill. If you have any questions, ask your doctor||
2321|029|H|or pharmacist.||
2321|030|H|   Take this medication by mouth with food as directed by your||
2321|031|H|doctor, usually once a day. The dosage is based on your medical||
2321|032|H|condition and response to treatment.||
2321|033|H|   Use this medication regularly to get the most benefit from it.||
2321|034|H|To help you remember, take it at the same time each day.||
2321|035|H|   Do not increase your dose or use this drug more often than||
2321|036|H|prescribed. Your condition will not improve any faster, and your||
2321|037|H|risk of serious side effects will increase.||
2321|038|H|   Tell your doctor if your condition does not get better or if||
2321|039|H|it gets worse.||
2321|040|B|||
2321|041|S|SIDE EFFECTS:  Abdominal pain, vomiting, heartburn, gas, and||
2321|042|S|diarrhea may occur as your body adjusts to the medication.||
2321|043|S|Headache, back pain, and tiredness may also occur. If any of||
2321|044|S|these effects last or get worse, tell your doctor or pharmacist||
2321|045|S|promptly.||
2321|046|S|   Remember that this medication has been prescribed because your||
2321|047|S|doctor has judged that the benefit to you is greater than the||
2321|048|S|risk of side effects. Many people using this medication do not||
2321|049|S|have serious side effects.||
2321|050|S|   A very serious allergic reaction to this drug is rare.||
2321|051|S|However, get medical help right away if you notice any symptoms||
2321|052|S|of a serious allergic reaction, including: rash, itching/swelling||
2321|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2321|054|S|breathing.||
2321|055|S|   This is not a complete list of possible side effects. If you||
2321|056|S|notice other effects not listed above, contact your doctor or||
2321|057|S|pharmacist.||
2321|058|S|   In the US -||
2321|059|S|   Call your doctor for medical advice about side effects. You||
2321|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2321|061|S|www.fda.gov/medwatch.||
2321|062|S|   In Canada - Call your doctor for medical advice about side||
2321|063|S|effects. You may report side effects to Health Canada at||
2321|064|S|1-866-234-2345.||
2321|065|B|||
2321|066|P|PRECAUTIONS:  Before using berotralstat, tell your doctor or||
2321|067|P|pharmacist if you are allergic to it; or if you have any other||
2321|068|P|allergies. This product may contain inactive ingredients, which||
2321|069|P|can cause allergic reactions or other problems. Talk to your||
2321|070|P|pharmacist for more details.||
2321|071|P|   Before using this medication, tell your doctor or pharmacist||
2321|072|P|your medical history, especially of: liver disease, dialysis.||
2321|073|P|   Before having surgery, tell your doctor or dentist about all||
2321|074|P|the products you use (including prescription drugs,||
2321|075|P|nonprescription drugs, and herbal products).||
2321|076|P|   During pregnancy, this medication should be used only when||
2321|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
2321|078|P|   It is unknown if this drug passes into breast milk. Consult||
2321|079|P|your doctor before breastfeeding.||
2321|080|B|||
2321|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2321|082|I|medications work or increase your risk for serious side effects.||
2321|083|I|This document does not contain all possible drug interactions.||
2321|084|I|Keep a list of all the products you use (including||
2321|085|I|prescription/nonprescription drugs and herbal products) and share||
2321|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
2321|087|I|the dosage of any medicines without your doctor's approval.||
2321|088|I|   Other medications can affect the removal of berotralstat from||
2321|089|I|your body, which may affect how berotralstat works. Examples||
2321|090|I|include rifamycins (such as rifampin, rifabutin), St. John's||
2321|091|I|wort, among others.||
2321|092|I|   This medication can slow down the removal of other medications||
2321|093|I|from your body, which may affect how they work. Examples of||
2321|094|I|affected drugs include elacestrant, flibanserin, lomitapide,||
2321|095|I|among others.||
2321|096|B|||
2321|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2321|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2321|099|O|poison control center right away. US residents can call||
2321|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2321|101|O|Symptoms of overdose may include: severe dizziness,||
2321|102|O|fast/irregular heartbeat, fainting.||
2321|103|B|||
2321|104|N|NOTES:  Do not share this medication with others.||
2321|105|N|   Lab and/or medical tests (such as liver function) may be done||
2321|106|N|while you are taking this medication. Keep all medical and lab||
2321|107|N|appointments.||
2321|108|B|||
2321|109|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2321|110|D|remember. If it is near the time of the next dose, skip the||
2321|111|D|missed dose. Take your next dose at the regular time. Do not||
2321|112|D|double the dose to catch up.||
2321|113|B|||
2321|114|R|STORAGE:  Store at room temperature away from light and moisture.||
2321|115|R|Do not store in the bathroom. Keep all medications away from||
2321|116|R|children and pets.||
2321|117|R|   Do not flush medications down the toilet or pour them into a||
2321|118|R|drain unless instructed to do so. Properly discard this product||
2321|119|R|when it is expired or no longer needed. Consult your pharmacist||
2321|120|R|or local waste disposal company.||
2321|121|B|||
2321|122|A|Information last revised March 2025.||
2321|123|A|Copyright(c) 2025 First Databank, Inc.||
2321|124|B|||
2322|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2322|002|Z|does NOT have all possible information about this product. This||
2322|003|Z|information does not assure that this product is safe, effective,||
2322|004|Z|or appropriate for you. This information is not individual||
2322|005|Z|medical advice and does not substitute for the advice of your||
2322|006|Z|health care professional. Always ask your health care||
2322|007|Z|professional for complete information about this product and your||
2322|008|Z|specific health needs.||
2322|009|B|||
2322|010|T|NAXITAMAB - INJECTION||
2322|011|F|(nax-IT-a-mab)||
2322|012|B|||
2322|013|C|COMMON BRAND NAME(S): Danyelza||
2322|014|B|||
2322|015|W|WARNING:  Infusion reactions (rarely fatal) may happen during the||
2322|016|W|infusion of this drug and for 24 hours afterward. Your doctor may||
2322|017|W|prescribe other medications (such as an antihistamine,||
2322|018|W|corticosteroid, H2 blocker, and acetaminophen) before each||
2322|019|W|treatment to help prevent these side effects. Get medical help||
2322|020|W|right away if you have any symptoms of infusion reactions such as||
2322|021|W|rash, flushing, itching/swelling (especially of the||
2322|022|W|face/tongue/throat), severe dizziness, trouble breathing,||
2322|023|W|wheezing, chest discomfort/pain. Your doctor may give you other||
2322|024|W|medications to help with these side effects or may slow down or||
2322|025|W|stop your treatment for some time.||
2322|026|W|   Naxitamab can cause serious nervous system problems. Pain is||
2322|027|W|common and can be severe. Tell your doctor right away if you have||
2322|028|W|pain in the abdomen, bones, neck, legs, or arms. Your doctor||
2322|029|W|should prescribe medications to help prevent and relieve pain||
2322|030|W|before and during treatment with this medication.||
2322|031|W|   Rarely, this medication may cause a condition called||
2322|032|W|reversible posterior leukoencephalopathy syndrome-RPLS, also||
2322|033|W|known as posterior reversible encephalopathy syndrome-PRES. Get||
2322|034|W|medical help right away if you develop headache that doesn't go||
2322|035|W|away, seizures, sudden vision changes, mental/mood changes (such||
2322|036|W|as confusion).||
2322|037|B|||
2322|038|U|USES:  This medication is used to treat a certain type of cancer||
2322|039|U|(neuroblastoma in bone or bone marrow). Naxitamab belongs to a||
2322|040|U|class of drugs known as monoclonal antibodies. It works by||
2322|041|U|slowing or stopping the growth of cancer cells.||
2322|042|B|||
2322|043|H|HOW TO USE:  See also Warning section.||
2322|044|H|   Read the Patient Information Leaflet if available from your||
2322|045|H|pharmacist before you start using naxitamab and each time you get||
2322|046|H|a refill. If you have any questions, ask your doctor or||
2322|047|H|pharmacist.||
2322|048|H|   This medication is given by injection into a vein as directed||
2322|049|H|by your doctor, usually on days 1, 3, and 5 of each treatment||
2322|050|H|cycle. A treatment cycle is usually every 4 or every 8 weeks. The||
2322|051|H|injection is given by a health care professional, usually over 30||
2322|052|H|to 60 minutes.||
2322|053|H|   The dosage and treatment schedule are based on your medical||
2322|054|H|condition, weight, and response to treatment.||
2322|055|B|||
2322|056|S|SIDE EFFECTS:  See also Warning section.||
2322|057|S|   Tiredness, nausea, vomiting, diarrhea, dizziness,||
2322|058|S|lightheadedness, or loss of appetite may occur. Nausea and||
2322|059|S|vomiting can be severe. In some cases, your doctor may prescribe||
2322|060|S|medication to prevent or relieve nausea and vomiting. Eating||
2322|061|S|several small meals, not eating before treatment, or limiting||
2322|062|S|activity may help lessen some of these effects. If any of these||
2322|063|S|effects last or get worse, tell your doctor or pharmacist||
2322|064|S|promptly.||
2322|065|S|   To reduce the risk of dizziness and lightheadedness, get up||
2322|066|S|slowly when rising from a sitting or lying position.||
2322|067|S|   People using this medication may have serious side effects.||
2322|068|S|However, you have been prescribed this drug because your doctor||
2322|069|S|has judged that the benefit to you is greater than the risk of||
2322|070|S|side effects. Careful monitoring by your doctor may decrease your||
2322|071|S|risk.||
2322|072|S|   This medication may raise your blood pressure. Check your||
2322|073|S|blood pressure regularly and tell your doctor if the results are||
2322|074|S|high.||
2322|075|S|   There have been rare reports of swelling of the heart muscle||
2322|076|S|(myocarditis) that has occurred within days of receiving this||
2322|077|S|medication. If you notice any of the following symptoms, tell||
2322|078|S|your doctor right away: chest pain, shortness of breath,||
2322|079|S|irregular/fast heartbeat.||
2322|080|S|   Tell your doctor right away if you have any serious side||
2322|081|S|effects, including: numbness/tingling (including in the arms or||
2322|082|S|legs), weakness in the arms or legs, trouble urinating, vision||
2322|083|S|changes (such as blurred vision, decreased vision).||
2322|084|S|   This medication may lower your ability to fight infections.||
2322|085|S|This may make you more likely to get a serious (rarely fatal)||
2322|086|S|infection or make any infection you have worse. Tell your doctor||
2322|087|S|right away if you have any signs of infection (such as sore||
2322|088|S|throat that doesn't go away, fever, chills).||
2322|089|S|   A very serious allergic reaction to this drug is rare.||
2322|090|S|However, get medical help right away if you notice any symptoms||
2322|091|S|of a serious allergic reaction, including: rash, itching/swelling||
2322|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2322|093|S|breathing.||
2322|094|S|   This is not a complete list of possible side effects. If you||
2322|095|S|notice other effects not listed above, contact your doctor or||
2322|096|S|pharmacist.||
2322|097|S|   In the US -||
2322|098|S|   Call your doctor for medical advice about side effects. You||
2322|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2322|100|S|www.fda.gov/medwatch.||
2322|101|S|   In Canada - Call your doctor for medical advice about side||
2322|102|S|effects. You may report side effects to Health Canada at||
2322|103|S|1-866-234-2345.||
2322|104|B|||
2322|105|P|PRECAUTIONS:  Before using naxitamab, tell your doctor or||
2322|106|P|pharmacist if you are allergic to it; or if you have any other||
2322|107|P|allergies. This product may contain inactive ingredients, which||
2322|108|P|can cause allergic reactions or other problems. Talk to your||
2322|109|P|pharmacist for more details.||
2322|110|P|   Before using this medication, tell your doctor or pharmacist||
2322|111|P|your medical history, especially of: high blood pressure, heart||
2322|112|P|disease.||
2322|113|P|   Naxitamab can make you more likely to get infections or may||
2322|114|P|make current infections worse. Stay away from anyone who has an||
2322|115|P|infection that may easily spread (such as chickenpox, COVID-19,||
2322|116|P|measles, flu). Talk to your doctor if you have been exposed to an||
2322|117|P|infection or for more details.||
2322|118|P|   Tell your health care professional that you are using||
2322|119|P|naxitamab before having any immunizations/vaccinations. Avoid||
2322|120|P|contact with people who have recently received live vaccines||
2322|121|P|(such as flu vaccine inhaled through the nose).||
2322|122|P|   To lower the chance of getting cut, bruised, or injured, use||
2322|123|P|caution with sharp objects like razors and nail cutters, and||
2322|124|P|avoid activities such as contact sports.||
2322|125|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
2322|126|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
2322|127|P|use machinery, or do anything that needs alertness or clear||
2322|128|P|vision until you can do it safely. Limit alcoholic beverages.||
2322|129|P|Talk to your doctor if you are using marijuana (cannabis).||
2322|130|P|   Before having surgery, tell your doctor or dentist about all||
2322|131|P|the products you use (including prescription drugs,||
2322|132|P|nonprescription drugs, and herbal products).||
2322|133|P|   Children may be at greater risk for a certain heart problem||
2322|134|P|(myocarditis) while using this drug.||
2322|135|P|   Tell your doctor if you are pregnant or plan to become||
2322|136|P|pregnant. You should not become pregnant while using naxitamab.||
2322|137|P|Naxitamab may harm an unborn baby. Your doctor may order a||
2322|138|P|pregnancy test before you start this medication. Ask about||
2322|139|P|reliable forms of birth control while using this medication and||
2322|140|P|for 2 months after the last dose. If you become pregnant, talk to||
2322|141|P|your doctor right away about the risks and benefits of this||
2322|142|P|medication.||
2322|143|P|   It is unknown if this drug passes into breast milk. Because of||
2322|144|P|the possible risk to the infant, breastfeeding is not recommended||
2322|145|P|while using this drug and for 2 months after the last dose.||
2322|146|P|Consult your doctor before breastfeeding.||
2322|147|B|||
2322|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2322|149|I|medications work or increase your risk for serious side effects.||
2322|150|I|This document does not contain all possible drug interactions.||
2322|151|I|Keep a list of all the products you use (including||
2322|152|I|prescription/nonprescription drugs and herbal products) and share||
2322|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
2322|154|I|the dosage of any medicines without your doctor's approval.||
2322|155|B|||
2322|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2322|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2322|158|O|poison control center right away. US residents can call||
2322|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2322|160|B|||
2322|161|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2322|162|N|blood pressure, blood mineral levels) should be done while you||
2322|163|N|are using this medication. Keep all medical and lab appointments.||
2322|164|B|||
2322|165|D|MISSED DOSE:  It is important to get each dose of this medication||
2322|166|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2322|167|D|right away for a new dosing schedule.||
2322|168|B|||
2322|169|R|STORAGE:  Not applicable. This medication is given in a hospital||
2322|170|R|or clinic and will not be stored at home.||
2322|171|B|||
2322|172|M|MEDICAL ALERT:  Your condition can cause complications in a||
2322|173|M|medical emergency. For information about enrolling in MedicAlert,||
2322|174|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2322|175|B|||
2322|176|A|Information last revised April 2025.||
2322|177|A|Copyright(c) 2025 First Databank, Inc.||
2322|178|B|||
2323|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2323|002|Z|does NOT have all possible information about this product. This||
2323|003|Z|information does not assure that this product is safe, effective,||
2323|004|Z|or appropriate for you. This information is not individual||
2323|005|Z|medical advice and does not substitute for the advice of your||
2323|006|Z|health care professional. Always ask your health care||
2323|007|Z|professional for complete information about this product and your||
2323|008|Z|specific health needs.||
2323|009|B|||
2323|010|T|TENAPANOR 50 MG - ORAL||
2323|011|F|(ten-A-pa-nor)||
2323|012|B|||
2323|013|C|COMMON BRAND NAME(S): Ibsrela||
2323|014|B|||
2323|015|W|WARNING:  This medication must not be used by children younger||
2323|016|W|than 6 years. It is not recommended for use by children who are 6||
2323|017|W|to less than 18 years due to the risk for harm (especially||
2323|018|W|serious dehydration). Talk to your doctor for details.||
2323|019|B|||
2323|020|U|USES:  See also Warning section.||
2323|021|U|   Tenapanor is used to treat a certain bowel problem (irritable||
2323|022|U|bowel syndrome with constipation). It works by increasing fluid||
2323|023|U|in your intestines and helping speed up movement of food through||
2323|024|U|the gut. Tenapanor may improve stool texture and lessen abdominal||
2323|025|U|pain/discomfort.||
2323|026|B|||
2323|027|V|OTHER USES:  This section contains uses of this drug that are not||
2323|028|V|listed in the approved professional labeling for the drug but||
2323|029|V|that may be prescribed by your health care professional. Use this||
2323|030|V|drug for a condition that is listed in this section only if it||
2323|031|V|has been so prescribed by your health care professional.||
2323|032|V|   Tenapanor is also available in other brands and other||
2323|033|V|strengths to lower high blood phosphate levels in people who are||
2323|034|V|on dialysis due to long-term kidney disease. Do not take this||
2323|035|V|medication with any other product that contains tenapanor.||
2323|036|B|||
2323|037|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2323|038|H|Patient Information Leaflet provided by your pharmacist before||
2323|039|H|you start taking tenapanor and each time you get a refill. If you||
2323|040|H|have any questions, ask your doctor or pharmacist.||
2323|041|H|   Take this medication by mouth as directed by your doctor,||
2323|042|H|usually twice daily: once immediately before your first meal of||
2323|043|H|the day, and once before dinner. Swallow the tablets whole. Do||
2323|044|H|not crush or chew the tablets.||
2323|045|H|   Use this medication regularly to get the most benefit from it.||
2323|046|H|To help you remember, take it at the same times each day.||
2323|047|H|   Tell your doctor if your condition does not get better or if||
2323|048|H|it gets worse.||
2323|049|B|||
2323|050|S|SIDE EFFECTS:  Diarrhea may occur. If this effect lasts or gets||
2323|051|S|worse, tell your doctor or pharmacist promptly.||
2323|052|S|   Remember that this medication has been prescribed because your||
2323|053|S|doctor has judged that the benefit to you is greater than the||
2323|054|S|risk of side effects. Many people using this medication do not||
2323|055|S|have serious side effects.||
2323|056|S|   Stop taking this medication and tell your doctor right away if||
2323|057|S|you have any serious side effects, including: severe diarrhea.||
2323|058|S|   A very serious allergic reaction to this drug is rare.||
2323|059|S|However, get medical help right away if you notice any symptoms||
2323|060|S|of a serious allergic reaction, including: rash, itching/swelling||
2323|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2323|062|S|breathing.||
2323|063|S|   This is not a complete list of possible side effects. If you||
2323|064|S|notice other effects not listed above, contact your doctor or||
2323|065|S|pharmacist.||
2323|066|S|   In the US -||
2323|067|S|   Call your doctor for medical advice about side effects. You||
2323|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2323|069|S|www.fda.gov/medwatch.||
2323|070|S|   In Canada - Call your doctor for medical advice about side||
2323|071|S|effects. You may report side effects to Health Canada at||
2323|072|S|1-866-234-2345.||
2323|073|B|||
2323|074|P|PRECAUTIONS:  Before taking tenapanor, tell your doctor or||
2323|075|P|pharmacist if you are allergic to it; or if you have any other||
2323|076|P|allergies. This product may contain inactive ingredients, which||
2323|077|P|can cause allergic reactions or other problems. Talk to your||
2323|078|P|pharmacist for more details.||
2323|079|P|   Before using this medication, tell your doctor or pharmacist||
2323|080|P|your medical history, especially of: stomach/intestinal blockage.||
2323|081|P|   Before having surgery, tell your doctor or dentist about all||
2323|082|P|the products you use (including prescription drugs,||
2323|083|P|nonprescription drugs, and herbal products).||
2323|084|P|   During pregnancy, this medication should be used only when||
2323|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
2323|086|P|   This medication does not pass into breast milk. Consult your||
2323|087|P|doctor before breastfeeding.||
2323|088|B|||
2323|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2323|090|I|medications work or increase your risk for serious side effects.||
2323|091|I|This document does not contain all possible drug interactions.||
2323|092|I|Keep a list of all the products you use (including||
2323|093|I|prescription/nonprescription drugs and herbal products) and share||
2323|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
2323|095|I|the dosage of any medicines without your doctor's approval.||
2323|096|B|||
2323|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2323|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2323|099|O|poison control center right away. US residents can call||
2323|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2323|101|B|||
2323|102|N|NOTES:  Do not share this medication with others.||
2323|103|B|||
2323|104|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2323|105|D|next dose at the regular time. Do not double the dose to catch||
2323|106|D|up.||
2323|107|B|||
2323|108|R|STORAGE:  Store in the original container at room temperature||
2323|109|R|away from light and moisture. Do not store in the bathroom. Keep||
2323|110|R|the drying agent (desiccant) in the container. Tightly close the||
2323|111|R|container when not in use. Keep all medications away from||
2323|112|R|children and pets.||
2323|113|R|   Do not flush medications down the toilet or pour them into a||
2323|114|R|drain unless instructed to do so. Properly discard this product||
2323|115|R|when it is expired or no longer needed. Consult your pharmacist||
2323|116|R|or local waste disposal company.||
2323|117|B|||
2323|118|A|Information last revised May 2025.||
2323|119|A|Copyright(c) 2025 First Databank, Inc.||
2323|120|B|||
2325|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2325|002|Z|does NOT have all possible information about this product. This||
2325|003|Z|information does not assure that this product is safe, effective,||
2325|004|Z|or appropriate for you. This information is not individual||
2325|005|Z|medical advice and does not substitute for the advice of your||
2325|006|Z|health care professional. Always ask your health care||
2325|007|Z|professional for complete information about this product and your||
2325|008|Z|specific health needs.||
2325|009|B|||
2325|010|T|RELUGOLIX - ORAL||
2325|011|F|(REL-ue-GOE-lix)||
2325|012|B|||
2325|013|C|COMMON BRAND NAME(S): Orgovyx||
2325|014|B|||
2325|015|U|USES:  Relugolix is used to treat prostate cancer in men. It is||
2325|016|U|not a cure. Most types of prostate cancer need the hormone||
2325|017|U|testosterone to grow and spread. Relugolix works by reducing the||
2325|018|U|amount of testosterone that the body makes. This helps slow or||
2325|019|U|stop the growth of cancer cells.||
2325|020|B|||
2325|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2325|022|H|from your pharmacist before you start using relugolix and each||
2325|023|H|time you get a refill. If you have any questions, ask your doctor||
2325|024|H|or pharmacist.||
2325|025|H|   Take this medication by mouth with or without food as directed||
2325|026|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2325|027|H|not chew, crush, or split the tablets.||
2325|028|H|   The dosage is based on your medical condition and other||
2325|029|H|medications you may be taking. Be sure to tell your doctor and||
2325|030|H|pharmacist about all the products you use (including prescription||
2325|031|H|drugs, nonprescription drugs, and herbal products).||
2325|032|H|   Do not increase your dose or take this drug more often than||
2325|033|H|directed. Your condition will not improve any faster, and your||
2325|034|H|risk of side effects will increase.||
2325|035|H|   Take this medication regularly to get the most benefit from||
2325|036|H|it. To help you remember, take it at the same time each day.||
2325|037|H|   Since this drug can be absorbed through the skin and lungs and||
2325|038|H|may harm an unborn baby, women who are pregnant or who may become||
2325|039|H|pregnant should not handle this medication or breathe the dust||
2325|040|H|from the tablets.||
2325|041|B|||
2325|042|S|SIDE EFFECTS:  Hot flashes (flushing), muscle/joint pain,||
2325|043|S|tiredness, constipation, and diarrhea may occur. Reduced sexual||
2325|044|S|interest/ability and weight gain may also occur as a result of||
2325|045|S|lowered testosterone levels. If any of these effects last or get||
2325|046|S|worse, tell your doctor or pharmacist promptly.||
2325|047|S|   Remember that this medication has been prescribed because your||
2325|048|S|doctor has judged that the benefit to you is greater than the||
2325|049|S|risk of side effects. Many people using this medication do not||
2325|050|S|have serious side effects.||
2325|051|S|   Tell your doctor right away if you have any serious side||
2325|052|S|effects, including: signs of kidney problems (such as a change in||
2325|053|S|the amount of urine), easy bleeding/bruising.||
2325|054|S|   Get medical help right away if you have any very serious side||
2325|055|S|effects, including: chest pain, fast/slow/irregular heartbeat,||
2325|056|S|severe dizziness, fainting.||
2325|057|S|   A very serious allergic reaction to this drug is rare.||
2325|058|S|However, get medical help right away if you notice any symptoms||
2325|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2325|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2325|061|S|breathing.||
2325|062|S|   This is not a complete list of possible side effects. If you||
2325|063|S|notice other effects not listed above, contact your doctor or||
2325|064|S|pharmacist.||
2325|065|S|   In the US -||
2325|066|S|   Call your doctor for medical advice about side effects. You||
2325|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2325|068|S|www.fda.gov/medwatch.||
2325|069|S|   In Canada - Call your doctor for medical advice about side||
2325|070|S|effects. You may report side effects to Health Canada at||
2325|071|S|1-866-234-2345.||
2325|072|B|||
2325|073|P|PRECAUTIONS:  Before taking relugolix, tell your doctor or||
2325|074|P|pharmacist if you are allergic to it; or if you have any other||
2325|075|P|allergies. This product may contain inactive ingredients, which||
2325|076|P|can cause allergic reactions or other problems. Talk to your||
2325|077|P|pharmacist for more details.||
2325|078|P|   Before using this medication, tell your doctor or pharmacist||
2325|079|P|your medical history.||
2325|080|P|   Relugolix may cause a condition that affects the heart rhythm||
2325|081|P|(QT prolongation). QT prolongation can rarely cause serious||
2325|082|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2325|083|P|as severe dizziness, fainting) that need medical attention right||
2325|084|P|away.||
2325|085|P|   The risk of QT prolongation may be increased if you have||
2325|086|P|certain medical conditions or are taking other drugs that may||
2325|087|P|cause QT prolongation. Before using relugolix, tell your doctor||
2325|088|P|or pharmacist of all the drugs you take and if you have any of||
2325|089|P|the following conditions: certain heart problems (heart failure,||
2325|090|P|slow heartbeat, QT prolongation in the EKG), family history of||
2325|091|P|certain heart problems (QT prolongation in the EKG, sudden||
2325|092|P|cardiac death).||
2325|093|P|   Low levels of potassium or magnesium in the blood may also||
2325|094|P|increase your risk of QT prolongation. This risk may increase if||
2325|095|P|you use certain drugs (such as diuretics/"water pills") or if you||
2325|096|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2325|097|P|Talk to your doctor about using relugolix safely.||
2325|098|P|   Before having surgery, tell your doctor or dentist about all||
2325|099|P|the products you use (including prescription drugs,||
2325|100|P|nonprescription drugs, and herbal products).||
2325|101|P|   Older adults may be more sensitive to the side effects of this||
2325|102|P|drug, especially QT prolongation (see above).||
2325|103|P|   This medication should not be used by women, especially during||
2325|104|P|pregnancy or breastfeeding. It may harm an unborn baby. Consult||
2325|105|P|your doctor for more details. Men with female partners of||
2325|106|P|childbearing age should use reliable forms of birth control||
2325|107|P|during treatment and for 2 weeks after stopping treatment. If||
2325|108|P|your partner becomes pregnant or thinks she may be pregnant, tell||
2325|109|P|the doctor right away.||
2325|110|B|||
2325|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2325|112|I|medications work or increase your risk for serious side effects.||
2325|113|I|This document does not contain all possible drug interactions.||
2325|114|I|Keep a list of all the products you use (including||
2325|115|I|prescription/nonprescription drugs and herbal products) and share||
2325|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
2325|117|I|the dosage of any medicines without your doctor's approval.||
2325|118|I|   Other medications can affect the removal of relugolix from||
2325|119|I|your body, which may affect how relugolix works. Examples include||
2325|120|I|erythromycin, among others.||
2325|121|I|   This medication may interfere with certain lab tests||
2325|122|I|(including pituitary gonadal function), possibly causing false||
2325|123|I|test results. Make sure lab personnel and all your doctors know||
2325|124|I|you use this drug.||
2325|125|B|||
2325|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2325|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2325|128|O|poison control center right away. US residents can call||
2325|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2325|130|B|||
2325|131|N|NOTES:  Lab and/or medical tests (such as PSA/testosterone||
2325|132|N|levels, liver function, blood glucose, triglyceride levels)||
2325|133|N|should be done while you are taking this medication. Keep all||
2325|134|N|medical and lab appointments. Consult your doctor for more||
2325|135|N|details.||
2325|136|B|||
2325|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2325|138|D|remember. If it is more than 12 hours after the missed dose, skip||
2325|139|D|the missed dose. Take your next dose at the regular time. Do not||
2325|140|D|double the dose to catch up.||
2325|141|B|||
2325|142|R|STORAGE:  Store in original container at room temperature away||
2325|143|R|from light and moisture. Do not store in the bathroom. Keep the||
2325|144|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
2325|145|R|when not in use. Keep all medications away from children and||
2325|146|R|pets.||
2325|147|R|   Do not flush medications down the toilet or pour them into a||
2325|148|R|drain unless instructed to do so. Properly discard this product||
2325|149|R|when it is expired or no longer needed. Consult your pharmacist||
2325|150|R|or local waste disposal company.||
2325|151|B|||
2325|152|A|Information last revised September 2025.||
2325|153|A|Copyright(c) 2025 First Databank, Inc.||
2325|154|B|||
2327|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2327|002|Z|does NOT have all possible information about this product. This||
2327|003|Z|information does not assure that this product is safe, effective,||
2327|004|Z|or appropriate for you. This information is not individual||
2327|005|Z|medical advice and does not substitute for the advice of your||
2327|006|Z|health care professional. Always ask your health care||
2327|007|Z|professional for complete information about this product and your||
2327|008|Z|specific health needs.||
2327|009|B|||
2327|010|T|ARSENIC TRIOXIDE - INJECTION||
2327|011|F|(AR-se-nik trye-OX-ide)||
2327|012|B|||
2327|013|C|COMMON BRAND NAME(S): Trisenox||
2327|014|B|||
2327|015|W|WARNING:  Arsenic trioxide is a strong medication that can cause||
2327|016|W|serious, rarely fatal side effects. To decrease your risk, your||
2327|017|W|doctor will monitor you closely during treatment.||
2327|018|W|   Rarely, this medication may cause a serious condition called||
2327|019|W|APL differentiation syndrome. Tell your doctor right away if the||
2327|020|W|following effects occur: unusual/unexplained fever, shortness of||
2327|021|W|breath/difficulty breathing, and/or weight gain. Your doctor may||
2327|022|W|direct you to weigh yourself regularly and report any sudden||
2327|023|W|weight gain. Your doctor may also perform certain exams or tests||
2327|024|W|(such as lung exam, X-rays) to determine if this syndrome has||
2327|025|W|developed.||
2327|026|W|   Rarely, this medication can also cause serious (rarely fatal)||
2327|027|W|heart problems (such as AV block, torsades de pointes-type||
2327|028|W|arrhythmias). Tell your doctor if you have any medical history of||
2327|029|W|heart problems (such as fast/irregular heartbeat, heart failure),||
2327|030|W|kidney problems, low levels of minerals in your blood (such as||
2327|031|W|calcium, potassium, magnesium). Also tell your doctor if you take||
2327|032|W|any medications that increase your risk for these heart problems||
2327|033|W|or low levels of minerals (see also Drug Interactions section).||
2327|034|W|To decrease your risk, your doctor may order a heart rhythm test||
2327|035|W|(EKG) or blood tests before and during treatment.||
2327|036|W|   Get medical help right away if you develop severe dizziness,||
2327|037|W|fainting, or fast/irregular heartbeat.||
2327|038|W|   This medication may increase your risk of getting a rare but||
2327|039|W|very serious (possibly fatal) brain disorder. This risk may be||
2327|040|W|higher if you have low levels of thiamine (vitamin B1), alcohol||
2327|041|W|use disorder, or difficulty absorbing nutrition from food||
2327|042|W|(malabsorption syndrome). Get medical help right away if you have||
2327|043|W|any of these side effects: clumsiness, loss of||
2327|044|W|coordination/balance, weakness, sudden change in your thinking||
2327|045|W|(such as confusion, difficulty concentrating, memory loss),||
2327|046|W|difficulty talking/walking, seizures, vision changes.||
2327|047|B|||
2327|048|U|USES:  Arsenic trioxide is used to treat a type of leukemia||
2327|049|U|(acute promyelocytic leukemia-APL).||
2327|050|B|||
2327|051|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2327|052|H|from your pharmacist before you start using arsenic trioxide and||
2327|053|H|each time you get a treatment. If you have any questions, ask||
2327|054|H|your doctor or pharmacist.||
2327|055|H|   This medication is given by injection into a vein by a health||
2327|056|H|care professional over 2 hours as directed by your doctor,||
2327|057|H|usually once daily. The injection may be injected more slowly||
2327|058|H|(such as over 4 hours) if you have a reaction to the medication||
2327|059|H|such as dizziness, flushing, or fast heartbeat.||
2327|060|H|   The dosage, treatment schedule, and length of treatment are||
2327|061|H|based on your weight, medical condition, and response to||
2327|062|H|treatment. Your doctor will order tests (such as EKG, blood||
2327|063|H|minerals) to find the right dose for you. Your next dose may need||
2327|064|H|to be rescheduled if your heartbeat or blood tests are abnormal.||
2327|065|B|||
2327|066|S|SIDE EFFECTS:  See also Warning section.||
2327|067|S|   Pain/redness/swelling at the injection site, nausea, vomiting,||
2327|068|S|diarrhea, stomach/abdominal pain, tiredness, cough, headache, or||
2327|069|S|dizziness may occur. If any of these effects last or get worse,||
2327|070|S|tell your doctor or pharmacist promptly.||
2327|071|S|   People using this medication may have serious side effects.||
2327|072|S|However, you have been prescribed this drug because your doctor||
2327|073|S|has judged that the benefit to you is greater than the risk of||
2327|074|S|side effects. Careful monitoring by your doctor may decrease your||
2327|075|S|risk.||
2327|076|S|   Both leukemia and this medication can lower the body's ability||
2327|077|S|to fight an infection. Tell your doctor right away if you develop||
2327|078|S|any signs of an infection (such as sore throat that doesn't go||
2327|079|S|away, fever, chills).||
2327|080|S|   Tell your doctor right away if you have any serious side||
2327|081|S|effects, including: easy bleeding/bruising, nosebleed, increased||
2327|082|S|thirst, signs of kidney problems (such as change in the amount of||
2327|083|S|urine), bone/joint pain, decreased appetite, unusual weight loss,||
2327|084|S|muscle pain/stiffness/spasm, numbness/tingling, swollen||
2327|085|S|hands/legs/feet, symptoms of liver disease (such as||
2327|086|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain,||
2327|087|S|yellowing eyes/skin, dark urine).||
2327|088|S|   Get medical help right away if you have any very serious side||
2327|089|S|effects, including: chest pain, severe dizziness/fainting,||
2327|090|S|fast/irregular heartbeat, coughing up blood, mental/mood changes||
2327|091|S|(such as confusion), muscle weakness, bloody/black/tarry stool,||
2327|092|S|vomit that looks like coffee grounds.||
2327|093|S|   People who are treated with this medication may rarely get||
2327|094|S|other cancers. Consult your doctor for more details.||
2327|095|S|   A very serious allergic reaction to this drug is rare.||
2327|096|S|However, get medical help right away if you notice any symptoms||
2327|097|S|of a serious allergic reaction, including: rash, itching/swelling||
2327|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2327|099|S|breathing.||
2327|100|S|   This is not a complete list of possible side effects. If you||
2327|101|S|notice any other effects not listed above, contact your doctor or||
2327|102|S|pharmacist.||
2327|103|S|   In the US -||
2327|104|S|   Call your doctor for medical advice about side effects. You||
2327|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2327|106|S|www.fda.gov/medwatch.||
2327|107|S|   In Canada - Call your doctor for medical advice about side||
2327|108|S|effects. You may report side effects to Health Canada at||
2327|109|S|1-866-234-2345.||
2327|110|B|||
2327|111|P|PRECAUTIONS:  See also Warning section.||
2327|112|P|   Before using this medication, tell your doctor or pharmacist||
2327|113|P|if you are allergic to arsenic; or if you have any other||
2327|114|P|allergies. This product may contain inactive ingredients, which||
2327|115|P|can cause allergic reactions or other problems. Talk to your||
2327|116|P|pharmacist for more details.||
2327|117|P|   Before using this medication, tell your doctor or pharmacist||
2327|118|P|your medical history, especially: kidney disease, diabetes.||
2327|119|P|   Arsenic trioxide may cause a condition that affects the heart||
2327|120|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2327|121|P|serious (rarely fatal) fast/irregular heartbeat and other||
2327|122|P|symptoms (such as severe dizziness, fainting) that need medical||
2327|123|P|attention right away.||
2327|124|P|   The risk of QT prolongation may be increased if you have||
2327|125|P|certain medical conditions or are taking other drugs that may||
2327|126|P|cause QT prolongation. Before using arsenic trioxide, tell your||
2327|127|P|doctor or pharmacist of all the drugs you take and if you have||
2327|128|P|any of the following conditions: certain heart problems (heart||
2327|129|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2327|130|P|history of certain heart problems (QT prolongation in the EKG,||
2327|131|P|sudden cardiac death).||
2327|132|P|   Low levels of potassium or magnesium in the blood may also||
2327|133|P|increase your risk of QT prolongation. This risk may increase if||
2327|134|P|you use certain drugs (such as diuretics/"water pills") or if you||
2327|135|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2327|136|P|Talk to your doctor about using arsenic trioxide safely.||
2327|137|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2327|138|P|can make you more dizzy. Do not drive, use machinery, or do||
2327|139|P|anything that needs alertness until you can do it safely. Limit||
2327|140|P|alcoholic beverages. Talk to your doctor if you are using||
2327|141|P|marijuana (cannabis).||
2327|142|P|   Arsenic trioxide can make you more likely to get infections or||
2327|143|P|may make current infections worse. Stay away from anyone who has||
2327|144|P|an infection that may easily spread (such as chickenpox,||
2327|145|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2327|146|P|exposed to an infection or for more details.||
2327|147|P|   Tell your health care professional that you are using arsenic||
2327|148|P|trioxide before having any immunizations/vaccinations. Avoid||
2327|149|P|contact with people who have recently received live vaccines||
2327|150|P|(such as flu vaccine inhaled through the nose).||
2327|151|P|   To lower the chance of getting cut, bruised, or injured, use||
2327|152|P|caution with sharp objects like razors and nail cutters, and||
2327|153|P|avoid activities such as contact sports.||
2327|154|P|   Older adults may be more sensitive to the side effects of this||
2327|155|P|drug, especially QT prolongation (see above).||
2327|156|P|   Tell your doctor if you are pregnant or plan to become||
2327|157|P|pregnant. You should not become pregnant while using arsenic||
2327|158|P|trioxide. Arsenic trioxide may harm an unborn baby. Your doctor||
2327|159|P|should order a pregnancy test before you start this medication.||
2327|160|P|Women using this medication should ask about reliable forms of||
2327|161|P|birth control during treatment and for 6 months after the last||
2327|162|P|dose. Men using this medication should ask about reliable forms||
2327|163|P|of birth control during treatment and for 3 months after the last||
2327|164|P|dose. If you or your partner becomes pregnant, talk to your||
2327|165|P|doctor right away about the risks and benefits of this||
2327|166|P|medication.||
2327|167|P|   This medication passes into breast milk. Because of the||
2327|168|P|possible risk to the infant, breastfeeding is not recommended||
2327|169|P|while using this medication and for 2 weeks after the last dose.||
2327|170|P|Consult your doctor before breastfeeding.||
2327|171|B|||
2327|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2327|173|I|medications work or increase your risk for serious side effects.||
2327|174|I|This document does not contain all possible drug interactions.||
2327|175|I|Keep a list of all the products you use (including||
2327|176|I|prescription/nonprescription drugs and herbal products) and share||
2327|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
2327|178|I|the dosage of any medicines without your doctor's approval.||
2327|179|I|   Many drugs besides arsenic trioxide may affect the heart||
2327|180|I|rhythm (QT prolongation), including amiodarone, dofetilide,||
2327|181|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
2327|182|I|(such as erythromycin), ziprasidone, among others. Before using||
2327|183|I|arsenic trioxide, report all medications you are currently using||
2327|184|I|to your doctor or pharmacist.||
2327|185|I|   Some products that may interact with this drug are: drugs that||
2327|186|I|lower blood minerals (such as amphotericin B), drugs that may||
2327|187|I|harm the immune system (such as chemotherapy), other drugs that||
2327|188|I|can cause bleeding/bruising (including antiplatelet drugs such as||
2327|189|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
2327|190|I|such as warfarin/dabigatran).||
2327|191|I|   Aspirin can increase the risk of bleeding when used with this||
2327|192|I|medication. However, if your doctor has told you to take low-dose||
2327|193|I|aspirin to prevent heart attack or stroke (usually 81-162||
2327|194|I|milligrams a day), you should keep taking the aspirin unless your||
2327|195|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2327|196|I|details.||
2327|197|B|||
2327|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2327|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2327|200|O|poison control center right away. US residents can call||
2327|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2327|202|O|Symptoms of overdose may include: seizures, muscle weakness,||
2327|203|O|confusion.||
2327|204|B|||
2327|205|N|NOTES:  Lab and/or medical tests (such as blood mineral levels,||
2327|206|N|complete blood count, EKG, blood glucose, liver function,||
2327|207|N|thiamine levels) should be done while you are using this||
2327|208|N|medication. Keep all medical and lab appointments. Consult your||
2327|209|N|doctor for more details.||
2327|210|B|||
2327|211|D|MISSED DOSE:  It is important to get each dose of this medication||
2327|212|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2327|213|D|right away for a new dosing schedule.||
2327|214|B|||
2327|215|R|STORAGE:  Not applicable. This medication is given in a clinic||
2327|216|R|and will not be stored at home.||
2327|217|B|||
2327|218|M|MEDICAL ALERT:  Your condition can cause complications in a||
2327|219|M|medical emergency. For information about enrolling in MedicAlert,||
2327|220|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2327|221|B|||
2327|222|A|Information last revised April 2025.||
2327|223|A|Copyright(c) 2025 First Databank, Inc.||
2327|224|B|||
2328|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2328|002|Z|does NOT have all possible information about this product. This||
2328|003|Z|information does not assure that this product is safe, effective,||
2328|004|Z|or appropriate for you. This information is not individual||
2328|005|Z|medical advice and does not substitute for the advice of your||
2328|006|Z|health care professional. Always ask your health care||
2328|007|Z|professional for complete information about this product and your||
2328|008|Z|specific health needs.||
2328|009|B|||
2328|010|T|INDACATEROL/MOMETASONE POWDER IN CAPSULE - ORAL INHALATION||
2328|011|F|(IN-da-KA-ter-ol/moe-MET-a-sone)||
2328|012|B|||
2328|013|U|USES:  This product is used to control and prevent symptoms||
2328|014|U|(wheezing and shortness of breath) caused by asthma. It contains||
2328|015|U|2 medications: indacaterol and mometasone. Indacaterol belongs to||
2328|016|U|the class of drugs known as long-acting beta agonists. It works||
2328|017|U|by relaxing the muscles around the airways so that they open up||
2328|018|U|and you can breathe more easily. Mometasone belongs to a class of||
2328|019|U|drugs known as corticosteroids. It works by reducing the||
2328|020|U|irritation and swelling of the airways.||
2328|021|U|   When used alone, long-acting beta agonists (such as||
2328|022|U|indacaterol) may rarely increase the risk of serious (sometimes||
2328|023|U|fatal) asthma-related breathing problems. However, combination||
2328|024|U|inhaled corticosteroid and long-acting beta agonists, such as||
2328|025|U|this product, do not increase the risk of serious asthma-related||
2328|026|U|breathing problems. This product should be used when breathing||
2328|027|U|problems are not well controlled with one asthma-control||
2328|028|U|medication (such as inhaled corticosteroid) or if your symptoms||
2328|029|U|need combination treatment.||
2328|030|U|   This medication should not be used for severe/sudden breathing||
2328|031|U|problems. Other medications, such as a quick-relief inhaler,||
2328|032|U|should be used instead of indacaterol/mometasone for sudden||
2328|033|U|breathing problems. This medication is not a substitute for||
2328|034|U|corticosteroids (such as beclomethasone, fluticasone,||
2328|035|U|prednisone).||
2328|036|B|||
2328|037|V|OTHER USES:  This section contains uses of this drug that are not||
2328|038|V|listed in the approved professional labeling for the drug but||
2328|039|V|that may be prescribed by your health care professional. Use this||
2328|040|V|drug for a condition that is listed in this section only if it||
2328|041|V|has been so prescribed by your health care professional.||
2328|042|V|   This medication may also be used to control symptoms (such as||
2328|043|V|wheezing and shortness of breath) caused by ongoing lung disease||
2328|044|V|(chronic obstructive pulmonary disease-COPD, which includes||
2328|045|V|chronic bronchitis and emphysema).||
2328|046|B|||
2328|047|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
2328|048|H|your pharmacist before you start using this medication and each||
2328|049|H|time you get a refill. Learn and follow the directions for proper||
2328|050|H|use and care of the inhaler device and this medication. If you||
2328|051|H|have any questions, ask your healthcare provider or pharmacist.||
2328|052|H|   Indacaterol/mometasone comes in a capsule. Do not swallow the||
2328|053|H|capsules. Inhale the contents of the capsule by mouth using the||
2328|054|H|inhaler device as directed by your doctor, usually one capsule||
2328|055|H|once daily. This medication must always be used with its own||
2328|056|H|special inhaler device. Always discard your old inhaler device||
2328|057|H|and use the new inhaler device that you get each time you refill||
2328|058|H|your indacaterol/mometasone prescription. Do not use a "spacer"||
2328|059|H|device with the inhaler.||
2328|060|H|   Leave the capsule sealed in the blister card until just before||
2328|061|H|use. Wash and completely dry hands before touching the capsules.||
2328|062|H|Inhale the capsule contents as directed to make sure you inhale||
2328|063|H|all of the drug. Be sure to inhale quickly and deeply through the||
2328|064|H|mouthpiece when using this drug. You should hear the inhaler make||
2328|065|H|a whirring noise as you inhale the medication. Hold your breath||
2328|066|H|for up to 5 seconds. Do not exhale or blow into the inhaler. Open||
2328|067|H|the inhaler to see if any powder is left in the capsule. If there||
2328|068|H|is, close the inhaler and inhale again. Inhale all of the powder||
2328|069|H|from each capsule.||
2328|070|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
2328|071|H|from developing, gargle, rinse your mouth with water and spit out||
2328|072|H|after each use. Do not swallow the rinse water.||
2328|073|H|   If you are using other inhalers at the same time, wait at||
2328|074|H|least one minute between the use of each medication.||
2328|075|H|   Use this medication regularly to get the most benefit from it.||
2328|076|H|This medication works best if used at evenly spaced intervals. To||
2328|077|H|help you remember, use it at the same time each day. Do not||
2328|078|H|increase your dose, use this medication more often, or stop using||
2328|079|H|it without first consulting your doctor. Also, do not use other||
2328|080|H|long-acting beta agonists while using this medication.||
2328|081|H|   If you are regularly taking a different corticosteroid by||
2328|082|H|mouth (such as prednisone), you should not stop taking it unless||
2328|083|H|directed by your doctor. Some conditions (such as asthma,||
2328|084|H|allergies) may become worse when the drug is suddenly stopped. If||
2328|085|H|you suddenly stop taking the drug, you may also have withdrawal||
2328|086|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
2328|087|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
2328|088|H|doctor may slowly lower the dose of your old medication after you||
2328|089|H|begin using indacaterol/mometasone. Tell your doctor or||
2328|090|H|pharmacist right away if you have withdrawal. See also||
2328|091|H|Precautions section.||
2328|092|H|   If you have been using a quick-relief inhaler (such as||
2328|093|H|albuterol, also called salbutamol in some countries) on a regular||
2328|094|H|daily schedule (such as 4 times daily), you must stop this||
2328|095|H|schedule and only use the quick-relief inhaler as needed for||
2328|096|H|sudden shortness of breath/asthma attacks. Consult your doctor||
2328|097|H|for details.||
2328|098|H|   Learn which of your inhalers you should use every day and||
2328|099|H|which you should use if your breathing suddenly worsens||
2328|100|H|(quick-relief drugs). Ask your doctor ahead of time what you||
2328|101|H|should do if you have new or worsening cough or shortness of||
2328|102|H|breath, wheezing, increased sputum, worsening peak flow meter||
2328|103|H|readings, waking up at night with trouble breathing, if you use||
2328|104|H|your quick-relief inhaler more often (more than 2 days a week),||
2328|105|H|or if your quick-relief inhaler does not seem to be working well.||
2328|106|H|Learn when you can treat sudden breathing problems by yourself||
2328|107|H|and when you must get medical help right away.||
2328|108|B|||
2328|109|S|SIDE EFFECTS:  Headache, hoarseness, dry/irritated throat, or||
2328|110|S|coughing may occur. If any of these effects last or get worse,||
2328|111|S|tell your doctor or pharmacist promptly.||
2328|112|S|   Remember that this medication has been prescribed because your||
2328|113|S|doctor has judged that the benefit to you is greater than the||
2328|114|S|risk of side effects. Many people using this medication do not||
2328|115|S|have serious side effects.||
2328|116|S|   This medication may raise your blood pressure. Check your||
2328|117|S|blood pressure regularly and tell your doctor if the results are||
2328|118|S|high.||
2328|119|S|   Rarely, this medication may cause sudden breathing||
2328|120|S|problems/wheezing right after you use it. If this occurs, use||
2328|121|S|your quick-relief inhaler and get medical help right away.||
2328|122|S|   Tell your doctor right away if you have any serious side||
2328|123|S|effects, including: white patches on tongue/in mouth, signs of||
2328|124|S|infection (such as sore throat that doesn't go away, fever,||
2328|125|S|chills), mental/mood changes (such as nervousness), trouble||
2328|126|S|sleeping, muscle weakness/cramps, increased thirst/urination,||
2328|127|S|shaking (tremors), vision problems (such as blurred vision).||
2328|128|S|   Get medical help right away if you have any very serious side||
2328|129|S|effects, including: chest pain, seizures.||
2328|130|S|   A very serious allergic reaction to this drug is rare.||
2328|131|S|However, get medical help right away if you notice any symptoms||
2328|132|S|of a serious allergic reaction, including: rash, itching/swelling||
2328|133|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2328|134|S|breathing.||
2328|135|S|   This is not a complete list of possible side effects. If you||
2328|136|S|notice other effects not listed above, contact your doctor or||
2328|137|S|pharmacist.||
2328|138|S|   In the US -||
2328|139|S|   Call your doctor for medical advice about side effects. You||
2328|140|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2328|141|S|www.fda.gov/medwatch.||
2328|142|S|   In Canada - Call your doctor for medical advice about side||
2328|143|S|effects. You may report side effects to Health Canada at||
2328|144|S|1-866-234-2345.||
2328|145|B|||
2328|146|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2328|147|P|pharmacist if you are allergic to indacaterol or mometasone; or||
2328|148|P|if you have any other allergies. This product may contain||
2328|149|P|inactive ingredients, which can cause allergic reactions or other||
2328|150|P|problems. Talk to your pharmacist for more details.||
2328|151|P|   Before using this medication, tell your doctor or pharmacist||
2328|152|P|your medical history, especially of: current/past infections||
2328|153|P|(such as tuberculosis, herpes), eye problems (such as cataracts,||
2328|154|P|glaucoma), high blood pressure, heart problems (such as irregular||
2328|155|P|heartbeat, chest pain), diabetes, bone loss (osteoporosis),||
2328|156|P|overactive thyroid (hyperthyroidism), seizures.||
2328|157|P|   If you have switched from a corticosteroid taken by mouth||
2328|158|P|(such as prednisone tablets) to this inhaler within the past 12||
2328|159|P|months, or if you have been using this product in||
2328|160|P|higher-than-usual doses for a long time, it may be more difficult||
2328|161|P|for your body to respond to physical stress. Before having||
2328|162|P|surgery or emergency treatment, or if you get a serious||
2328|163|P|illness/injury, tell your doctor or dentist that you are using||
2328|164|P|this medication or have used a corticosteroid taken by mouth||
2328|165|P|within the past 12 months. Tell your doctor right away if you||
2328|166|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
2328|167|P|card or medical ID bracelet that says you use (or have used)||
2328|168|P|corticosteroid medications.||
2328|169|P|   This medication may mask signs of infection. It can make you||
2328|170|P|more likely to get infections or may make current infections||
2328|171|P|worse. Stay away from anyone who has an infection that may easily||
2328|172|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2328|173|P|doctor if you have been exposed to an infection or for more||
2328|174|P|details.||
2328|175|P|   Before having surgery, tell your doctor or dentist about all||
2328|176|P|the products you use (including prescription drugs,||
2328|177|P|nonprescription drugs, and herbal products).||
2328|178|P|   This medication may slow down a child's growth if used for a||
2328|179|P|long time, but poorly controlled asthma can also slow down||
2328|180|P|growth. The effect on final adult height is unknown. See the||
2328|181|P|doctor regularly so your child's height can be checked.||
2328|182|P|   During pregnancy, this medication should be used only when||
2328|183|P|clearly needed. Discuss the risks and benefits with your doctor.||
2328|184|P|   It is unknown if indacaterol or mometasone pass into breast||
2328|185|P|milk. Consult your doctor before breastfeeding.||
2328|186|B|||
2328|187|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2328|188|I|medications work or increase your risk for serious side effects.||
2328|189|I|This document does not contain all possible drug interactions.||
2328|190|I|Keep a list of all the products you use (including||
2328|191|I|prescription/nonprescription drugs and herbal products) and share||
2328|192|I|it with your doctor and pharmacist. Do not start, stop, or change||
2328|193|I|the dosage of any medicines without your doctor's approval.||
2328|194|I|   A product that may interact with this drug is: desmopressin.||
2328|195|I|   Do not use other LABA drugs (such as formoterol, salmeterol)||
2328|196|I|while using this medication.||
2328|197|B|||
2328|198|O|OVERDOSE:  This medication will not work and may be harmful if||
2328|199|O|swallowed. If someone has overdosed and has serious symptoms such||
2328|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2328|201|O|poison control center right away. US residents can call||
2328|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2328|203|O|Symptoms of overdose may include: fast/irregular heartbeat,||
2328|204|O|severe nervousness, severe muscle cramps.||
2328|205|B|||
2328|206|N|NOTES:  Do not share this medication with others.||
2328|207|N|   Lab and/or medical tests (such as blood pressure, lung||
2328|208|N|function, eye exams, bone density tests) may be done while you||
2328|209|N|are using this medication. Keep all medical and lab appointments.||
2328|210|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
2328|211|N|mold that can worsen breathing problems. Because the flu virus||
2328|212|N|can also worsen breathing problems, ask your doctor or pharmacist||
2328|213|N|if you should have a flu shot every year.||
2328|214|N|   This medication may cause bone loss (osteoporosis) in adults||
2328|215|N|when used for a long time. Lifestyle changes that may help reduce||
2328|216|N|the risk of bone problems include doing weight-bearing exercise,||
2328|217|N|stopping smoking, limiting alcohol, and getting enough calcium||
2328|218|N|and vitamin D. Talk to your doctor for more details.||
2328|219|B|||
2328|220|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2328|221|D|If it is near the time of the next dose, skip the missed dose.||
2328|222|D|Use your next dose at the regular time. Do not double the dose to||
2328|223|D|catch up.||
2328|224|B|||
2328|225|R|STORAGE:  Store at room temperature away from light and moisture.||
2328|226|R|Do not store in the bathroom. Keep all medications away from||
2328|227|R|children and pets.||
2328|228|R|   Do not flush medications down the toilet or pour them into a||
2328|229|R|drain unless instructed to do so. Properly discard this product||
2328|230|R|when it is expired or no longer needed. Consult your pharmacist||
2328|231|R|or local waste disposal company.||
2328|232|B|||
2328|233|M|MEDICAL ALERT:  Your condition can cause complications in a||
2328|234|M|medical emergency. For information about enrolling in MedicAlert,||
2328|235|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2328|236|B|||
2328|237|A|Information last revised September 2025.||
2328|238|A|Copyright(c) 2025 First Databank, Inc.||
2328|239|B|||
2329|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2329|002|Z|does NOT have all possible information about this product. This||
2329|003|Z|information does not assure that this product is safe, effective,||
2329|004|Z|or appropriate for you. This information is not individual||
2329|005|Z|medical advice and does not substitute for the advice of your||
2329|006|Z|health care professional. Always ask your health care||
2329|007|Z|professional for complete information about this product and your||
2329|008|Z|specific health needs.||
2329|009|B|||
2329|010|T|INDACATEROL/GLYCOPYRRONIUM/MOMETASONE POWDER - ORAL INHALATION||
2329|011|F|(IN-da-KA-ter-ol/GLYE-koe-pir-OH-nee-um/moe-MET-a-sone)||
2329|012|B|||
2329|013|U|USES:  This product is used to control and prevent symptoms||
2329|014|U|(wheezing and shortness of breath) caused by asthma. It contains||
2329|015|U|3 medications: indacaterol, glycopyrronium, and mometasone.||
2329|016|U|Indacaterol belongs to the class of drugs known as long-acting||
2329|017|U|beta agonists. Glycopyrronium belongs to a class of drugs known||
2329|018|U|as long-acting muscarinic antagonists (LAMA). Indacaterol and||
2329|019|U|glycopyrronium are known as bronchodilators. They work by||
2329|020|U|relaxing the muscles around the airways so that they open up and||
2329|021|U|you can breathe more easily. Mometasone belongs to a class of||
2329|022|U|drugs known as corticosteroids. It works by reducing the||
2329|023|U|irritation and swelling of the airways.||
2329|024|U|   When used alone, long-acting beta agonists (such as||
2329|025|U|indacaterol) may rarely increase the risk of serious (sometimes||
2329|026|U|fatal) asthma-related breathing problems. However, combination||
2329|027|U|inhaled corticosteroid and long-acting beta agonists, such as||
2329|028|U|this product, do not increase the risk of serious asthma-related||
2329|029|U|breathing problems. This product should be used when breathing||
2329|030|U|problems are not well controlled with one asthma-control||
2329|031|U|medication (such as inhaled corticosteroid) or if your symptoms||
2329|032|U|need combination treatment.||
2329|033|U|   This medication should not be used for severe/sudden breathing||
2329|034|U|problems. Other medications, such as a quick-relief inhaler,||
2329|035|U|should be used instead of this product for sudden breathing||
2329|036|U|problems. This medication is not a substitute for corticosteroids||
2329|037|U|(such as beclomethasone, fluticasone, prednisone).||
2329|038|B|||
2329|039|V|OTHER USES:  This section contains uses of this drug that are not||
2329|040|V|listed in the approved professional labeling for the drug but||
2329|041|V|that may be prescribed by your health care professional. Use this||
2329|042|V|drug for a condition that is listed in this section only if it||
2329|043|V|has been so prescribed by your health care professional.||
2329|044|V|   This product may also be used to control symptoms (such as||
2329|045|V|wheezing and shortness of breath) caused by ongoing lung disease||
2329|046|V|(chronic obstructive pulmonary disease-COPD, which includes||
2329|047|V|chronic bronchitis and emphysema).||
2329|048|B|||
2329|049|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
2329|050|H|your pharmacist before you start using this medication and each||
2329|051|H|time you get a refill. Learn and follow the directions for proper||
2329|052|H|use and care of the inhaler device and this medication. If you||
2329|053|H|have any questions, ask your healthcare provider or pharmacist.||
2329|054|H|   Indacaterol/glycopyrronium/mometasone comes in a capsule. Do||
2329|055|H|not swallow the capsules. Inhale the contents of the capsule by||
2329|056|H|mouth using the inhaler device as directed by your doctor,||
2329|057|H|usually one capsule once daily. This medication must always be||
2329|058|H|used with its own special inhaler device. Always discard your old||
2329|059|H|inhaler device and use the new inhaler device that you get each||
2329|060|H|time you refill your indacaterol/glycopyrronium/mometasone||
2329|061|H|prescription. Do not use a "spacer" device with the inhaler.||
2329|062|H|   Leave the capsule sealed in the blister card until just before||
2329|063|H|use. Wash and completely dry hands before touching the capsules.||
2329|064|H|Inhale the capsule contents as directed to make sure you inhale||
2329|065|H|all of the drug. Be sure to inhale quickly and deeply through the||
2329|066|H|mouthpiece when using this drug. You should hear the inhaler make||
2329|067|H|a whirring noise as you inhale the medication. Hold your breath||
2329|068|H|for up to 5 seconds. Do not exhale or blow into the inhaler. Open||
2329|069|H|the inhaler to see if any powder is left in the capsule. If there||
2329|070|H|is, close the inhaler and inhale again. Inhale all of the powder||
2329|071|H|from each capsule.||
2329|072|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
2329|073|H|from developing, gargle, rinse your mouth with water and spit out||
2329|074|H|after each use. Do not swallow the rinse water.||
2329|075|H|   If you are using other inhalers at the same time, wait at||
2329|076|H|least one minute between the use of each medication.||
2329|077|H|   Use this medication regularly to get the most benefit from it.||
2329|078|H|This medication works best if used at evenly spaced intervals. To||
2329|079|H|help you remember, use it at the same time each day. Do not||
2329|080|H|increase your dose, use this medication more often, or stop using||
2329|081|H|it without first consulting your doctor. Also, do not use other||
2329|082|H|long-acting beta agonists while using this medication.||
2329|083|H|   If you are regularly taking a different corticosteroid by||
2329|084|H|mouth (such as prednisone), you should not stop taking it unless||
2329|085|H|directed by your doctor. Some conditions (such as asthma,||
2329|086|H|allergies) may become worse when the drug is suddenly stopped. If||
2329|087|H|you suddenly stop taking the drug, you may also have withdrawal||
2329|088|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
2329|089|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
2329|090|H|doctor may slowly lower the dose of your old medication after you||
2329|091|H|begin using indacaterol/glycopyrronium/mometasone. Tell your||
2329|092|H|doctor or pharmacist right away if you have withdrawal. See also||
2329|093|H|Precautions section.||
2329|094|H|   If you have been using a quick-relief inhaler (such as||
2329|095|H|albuterol, also called salbutamol in some countries) on a regular||
2329|096|H|daily schedule (such as 4 times daily), you must stop this||
2329|097|H|schedule and only use the quick-relief inhaler as needed for||
2329|098|H|sudden shortness of breath/asthma attacks. Consult your doctor||
2329|099|H|for details.||
2329|100|H|   Learn which of your inhalers you should use every day and||
2329|101|H|which you should use if your breathing suddenly worsens||
2329|102|H|(quick-relief drugs). Ask your doctor ahead of time what you||
2329|103|H|should do if you have new or worsening cough or shortness of||
2329|104|H|breath, wheezing, increased sputum, worsening peak flow meter||
2329|105|H|readings, waking up at night with trouble breathing, if you use||
2329|106|H|your quick-relief inhaler more often (more than 2 days a week),||
2329|107|H|or if your quick-relief inhaler does not seem to be working well.||
2329|108|H|Learn when you can treat sudden breathing problems by yourself||
2329|109|H|and when you must get medical help right away.||
2329|110|B|||
2329|111|S|SIDE EFFECTS:  Headache, hoarseness, dry/irritated throat, or||
2329|112|S|coughing may occur. If any of these effects last or get worse,||
2329|113|S|tell your doctor or pharmacist promptly.||
2329|114|S|   Remember that this medication has been prescribed because your||
2329|115|S|doctor has judged that the benefit to you is greater than the||
2329|116|S|risk of side effects. Many people using this medication do not||
2329|117|S|have serious side effects.||
2329|118|S|   This medication may raise your blood pressure. Check your||
2329|119|S|blood pressure regularly and tell your doctor if the results are||
2329|120|S|high.||
2329|121|S|   Rarely, this medication may cause sudden breathing||
2329|122|S|problems/wheezing right after you use it. If this occurs, use||
2329|123|S|your quick-relief inhaler and get medical help right away.||
2329|124|S|   Tell your doctor right away if you have any serious side||
2329|125|S|effects, including: white patches on tongue/in mouth, signs of||
2329|126|S|infection (such as sore throat that doesn't go away, fever,||
2329|127|S|chills), mental/mood changes (such as nervousness), trouble||
2329|128|S|sleeping, muscle weakness/cramps, increased thirst/urination,||
2329|129|S|difficult/painful urination, shaking (tremors), eye||
2329|130|S|pain/swelling/redness, vision changes (such as blurred vision).||
2329|131|S|   Get medical help right away if you have any very serious side||
2329|132|S|effects, including: chest pain, seizures.||
2329|133|S|   A very serious allergic reaction to this drug is rare.||
2329|134|S|However, get medical help right away if you notice any symptoms||
2329|135|S|of a serious allergic reaction, including: rash, itching/swelling||
2329|136|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2329|137|S|breathing.||
2329|138|S|   This is not a complete list of possible side effects. If you||
2329|139|S|notice other effects not listed above, contact your doctor or||
2329|140|S|pharmacist.||
2329|141|S|   In the US -||
2329|142|S|   Call your doctor for medical advice about side effects. You||
2329|143|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2329|144|S|www.fda.gov/medwatch.||
2329|145|S|   In Canada - Call your doctor for medical advice about side||
2329|146|S|effects. You may report side effects to Health Canada at||
2329|147|S|1-866-234-2345.||
2329|148|B|||
2329|149|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2329|150|P|pharmacist if you are allergic to indacaterol, glycopyrronium, or||
2329|151|P|mometasone; or if you have any other allergies. This product may||
2329|152|P|contain inactive ingredients, which can cause allergic reactions||
2329|153|P|or other problems. Talk to your pharmacist for more details.||
2329|154|P|   Before using this medication, tell your doctor or pharmacist||
2329|155|P|your medical history, especially of: current/past infections||
2329|156|P|(such as tuberculosis, herpes), eye problems (such as cataracts,||
2329|157|P|glaucoma), high blood pressure, heart problems (such as irregular||
2329|158|P|heartbeat, chest pain), diabetes, bone loss (osteoporosis),||
2329|159|P|kidney problems, overactive thyroid (hyperthyroidism), difficulty||
2329|160|P|urinating (such as due to an enlarged prostate), seizures.||
2329|161|P|   If you have switched from a corticosteroid taken by mouth||
2329|162|P|(such as prednisone tablets) to this inhaler within the past 12||
2329|163|P|months, or if you have been using this product in||
2329|164|P|higher-than-usual doses for a long time, it may be more difficult||
2329|165|P|for your body to respond to physical stress. Before having||
2329|166|P|surgery or emergency treatment, or if you get a serious||
2329|167|P|illness/injury, tell your doctor or dentist that you are using||
2329|168|P|this medication or have used a corticosteroid taken by mouth||
2329|169|P|within the past 12 months. Tell your doctor right away if you||
2329|170|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
2329|171|P|card or medical ID bracelet that says you use (or have used)||
2329|172|P|corticosteroid medications.||
2329|173|P|   This medication may mask signs of infection. It can make you||
2329|174|P|more likely to get infections or may make current infections||
2329|175|P|worse. Stay away from anyone who has an infection that may easily||
2329|176|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2329|177|P|doctor if you have been exposed to an infection or for more||
2329|178|P|details.||
2329|179|P|   Before having surgery, tell your doctor or dentist about all||
2329|180|P|the products you use (including prescription drugs,||
2329|181|P|nonprescription drugs, and herbal products).||
2329|182|P|   This medication may slow down a child's growth if used for a||
2329|183|P|long time, but poorly controlled asthma can also slow down||
2329|184|P|growth. The effect on final adult height is unknown. See the||
2329|185|P|doctor regularly so your child's height can be checked.||
2329|186|P|   During pregnancy, this medication should be used only when||
2329|187|P|clearly needed. Discuss the risks and benefits with your doctor.||
2329|188|P|   It is unknown if this medication passes into breast milk.||
2329|189|P|Consult your doctor before breastfeeding.||
2329|190|B|||
2329|191|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2329|192|I|medications work or increase your risk for serious side effects.||
2329|193|I|This document does not contain all possible drug interactions.||
2329|194|I|Keep a list of all the products you use (including||
2329|195|I|prescription/nonprescription drugs and herbal products) and share||
2329|196|I|it with your doctor and pharmacist. Do not start, stop, or change||
2329|197|I|the dosage of any medicines without your doctor's approval.||
2329|198|I|   A product that may interact with this drug is: desmopressin.||
2329|199|I|   Do not use other LABA drugs (such as formoterol, salmeterol)||
2329|200|I|while using this medication.||
2329|201|B|||
2329|202|O|OVERDOSE:  This medication will not work and may be harmful if||
2329|203|O|swallowed. If someone has overdosed and has serious symptoms such||
2329|204|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2329|205|O|poison control center right away. US residents can call||
2329|206|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2329|207|O|Symptoms of overdose may include: fast/irregular heartbeat,||
2329|208|O|severe nervousness, severe muscle cramps.||
2329|209|B|||
2329|210|N|NOTES:  Do not share this medication with others.||
2329|211|N|   Lab and/or medical tests (such as blood pressure, lung||
2329|212|N|function, eye exams, bone density tests) may be done while you||
2329|213|N|are using this medication. Keep all medical and lab appointments.||
2329|214|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
2329|215|N|mold that can worsen breathing problems. Because the flu virus||
2329|216|N|can also worsen breathing problems, ask your doctor or pharmacist||
2329|217|N|if you should have a flu shot every year.||
2329|218|N|   This medication may cause bone loss (osteoporosis) in adults||
2329|219|N|when used for a long time. Lifestyle changes that may help reduce||
2329|220|N|the risk of bone problems include doing weight-bearing exercise,||
2329|221|N|stopping smoking, limiting alcohol, and getting enough calcium||
2329|222|N|and vitamin D. Talk to your doctor for more details.||
2329|223|B|||
2329|224|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2329|225|D|If it is near the time of the next dose, skip the missed dose.||
2329|226|D|Use your next dose at the regular time. Do not double the dose to||
2329|227|D|catch up.||
2329|228|B|||
2329|229|R|STORAGE:  Store at room temperature away from light and moisture.||
2329|230|R|Do not store in the bathroom. Keep all medications away from||
2329|231|R|children and pets.||
2329|232|R|   Do not flush medications down the toilet or pour them into a||
2329|233|R|drain unless instructed to do so. Properly discard this product||
2329|234|R|when it is expired or no longer needed. Consult your pharmacist||
2329|235|R|or local waste disposal company.||
2329|236|B|||
2329|237|M|MEDICAL ALERT:  Your condition can cause complications in a||
2329|238|M|medical emergency. For information about enrolling in MedicAlert,||
2329|239|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2329|240|B|||
2329|241|A|Information last revised September 2025.||
2329|242|A|Copyright(c) 2025 First Databank, Inc.||
2329|243|B|||
2330|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2330|002|Z|does NOT have all possible information about this product. This||
2330|003|Z|information does not assure that this product is safe, effective,||
2330|004|Z|or appropriate for you. This information is not individual||
2330|005|Z|medical advice and does not substitute for the advice of your||
2330|006|Z|health care professional. Always ask your health care||
2330|007|Z|professional for complete information about this product and your||
2330|008|Z|specific health needs.||
2330|009|B|||
2330|010|T|FOSAMPRENAVIR - ORAL||
2330|011|F|(fos-am-PREN-uh-veer)||
2330|012|B|||
2330|013|C|COMMON BRAND NAME(S): Lexiva||
2330|014|B|||
2330|015|U|USES:  This drug is used with other HIV medications to help||
2330|016|U|control HIV infection. It helps to decrease the amount of HIV in||
2330|017|U|your body so your immune system can work better. This lowers your||
2330|018|U|chance of getting HIV complications (such as new infections,||
2330|019|U|cancer) and improves your quality of life.||
2330|020|U|   Fosamprenavir belongs to a class of drugs known as protease||
2330|021|U|inhibitors. It may be given with ritonavir, another protease||
2330|022|U|inhibitor, to increase ("boost") the levels of fosamprenavir.||
2330|023|U|This helps fosamprenavir work better.||
2330|024|U|   Fosamprenavir is not a cure for HIV infection. To decrease||
2330|025|U|your risk of spreading HIV disease to others, continue to take||
2330|026|U|all HIV medications exactly as prescribed by your doctor. Use an||
2330|027|U|effective barrier method (latex or polyurethane condoms/dental||
2330|028|U|dams) during sexual activity as directed by your doctor. Do not||
2330|029|U|share personal items (such as needles/syringes, toothbrushes, and||
2330|030|U|razors) that may have contacted blood or other body fluids.||
2330|031|U|Consult your doctor or pharmacist for more details.||
2330|032|B|||
2330|033|V|OTHER USES:  This section contains uses of this drug that are not||
2330|034|V|listed in the approved professional labeling for the drug but||
2330|035|V|that may be prescribed by your health care professional. Use this||
2330|036|V|drug for a condition that is listed in this section only if it||
2330|037|V|has been so prescribed by your health care professional.||
2330|038|V|   This product may also be used to lessen the risk of HIV||
2330|039|V|infection after contact with the virus (for example, due to a||
2330|040|V|needle stick). Ask your doctor for more details.||
2330|041|B|||
2330|042|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2330|043|H|from your pharmacist before you start taking fosamprenavir and||
2330|044|H|each time you get a refill. If you have any questions, ask your||
2330|045|H|doctor or pharmacist.||
2330|046|H|   Take this medication by mouth as directed by your doctor,||
2330|047|H|usually once or twice daily.||
2330|048|H|   Fosamprenavir tablets may be taken with or without food.||
2330|049|H|   If you are taking fosamprenavir suspension, shake the bottle||
2330|050|H|well before each dose. Carefully measure the dose using a special||
2330|051|H|measuring device/spoon. Do not use a household spoon because you||
2330|052|H|may not get the correct dose. Adults should take the suspension||
2330|053|H|without food. Children should take the suspension with food. If||
2330|054|H|vomiting occurs less than 30 minutes after taking a dose, repeat||
2330|055|H|the dose.||
2330|056|H|   The dosage is based on your medical condition, response to||
2330|057|H|treatment, other medications you may be taking, and if you have||
2330|058|H|taken protease inhibitors to treat HIV before. Children's dosage||
2330|059|H|is also based on age and weight. Be sure to tell your doctor and||
2330|060|H|pharmacist about all the products you use (including prescription||
2330|061|H|drugs, nonprescription drugs, and herbal products). If you are||
2330|062|H|directed to take ritonavir with this medication, take them both||
2330|063|H|at the same time(s).||
2330|064|H|   For the best effect, take this medication at evenly spaced||
2330|065|H|times. To help you remember, take this medication at the same||
2330|066|H|time(s) every day.||
2330|067|H|   It is very important to keep taking this medication (and other||
2330|068|H|HIV medications) exactly as prescribed by your doctor. Do not||
2330|069|H|skip any doses. Do not take more or less of this drug than||
2330|070|H|prescribed or stop taking it (or other HIV medicines) even for a||
2330|071|H|short time unless directed to do so by your doctor. Doing so may||
2330|072|H|cause the amount of virus to increase, make the infection more||
2330|073|H|difficult to treat (resistant), or worsen side effects.||
2330|074|B|||
2330|075|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, and headache may||
2330|076|S|occur. If any of these effects last or get worse, tell your||
2330|077|S|doctor or pharmacist promptly.||
2330|078|S|   Remember that this medication has been prescribed because your||
2330|079|S|doctor has judged that the benefit to you is greater than the||
2330|080|S|risk of side effects. Many people using this medication do not||
2330|081|S|have serious side effects.||
2330|082|S|   As your immune system gets stronger, it can begin to fight off||
2330|083|S|infections you already had, possibly causing disease symptoms to||
2330|084|S|come back. You could also have symptoms if your immune system||
2330|085|S|becomes overactive. This reaction may happen at any time (soon||
2330|086|S|after starting HIV treatment or many months later). Tell your||
2330|087|S|doctor right away if you have any serious symptoms, including:||
2330|088|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
2330|089|S|that doesn't go away, headaches that are severe or don't go away,||
2330|090|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
2330|091|S|changes, signs of infection (such as sore throat that doesn't go||
2330|092|S|away, fever, chills, swollen lymph nodes, non-healing skin||
2330|093|S|sores), signs of an overactive thyroid (such as irritability,||
2330|094|S|nervousness, heat intolerance, fast/pounding/irregular||
2330|095|S|heartbeat), signs of liver disease (such as nausea/vomiting that||
2330|096|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
2330|097|S|eyes/skin, dark urine).||
2330|098|S|   Tell your doctor right away if you have any serious side||
2330|099|S|effects, including: increased thirst/urination, signs of a kidney||
2330|100|S|stone (such as pain in side/back/abdomen, painful urination,||
2330|101|S|blood in the urine).||
2330|102|S|   Changes in body fat may occur while you are taking this||
2330|103|S|medication (such as increased fat in the upper back and stomach||
2330|104|S|areas, decreased fat in the arms and legs). The cause and||
2330|105|S|long-term effects of these changes are unknown. Discuss the risks||
2330|106|S|and benefits of treatment with your doctor, as well as the||
2330|107|S|possible use of exercise to reduce this side effect.||
2330|108|S|   Get medical help right away if you have any very serious side||
2330|109|S|effects, including: signs of a heart attack (such as||
2330|110|S|chest/jaw/left arm pain, shortness of breath, unusual sweating).||
2330|111|S|   Fosamprenavir can commonly cause a rash that is usually not||
2330|112|S|serious. However, you may not be able to tell it apart from a||
2330|113|S|rare rash that could be a sign of a severe reaction. Get medical||
2330|114|S|help right away if you develop any rash.||
2330|115|S|   A very serious allergic reaction to this drug is rare.||
2330|116|S|However, get medical help right away if you notice any symptoms||
2330|117|S|of a serious allergic reaction, including: rash, itching/swelling||
2330|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2330|119|S|breathing.||
2330|120|S|   This is not a complete list of possible side effects. If you||
2330|121|S|notice other effects not listed above, contact your doctor or||
2330|122|S|pharmacist.||
2330|123|S|   In the US -||
2330|124|S|   Call your doctor for medical advice about side effects. You||
2330|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2330|126|S|www.fda.gov/medwatch.||
2330|127|S|   In Canada - Call your doctor for medical advice about side||
2330|128|S|effects. You may report side effects to Health Canada at||
2330|129|S|1-866-234-2345.||
2330|130|B|||
2330|131|P|PRECAUTIONS:  Before taking fosamprenavir, tell your doctor or||
2330|132|P|pharmacist if you are allergic to it or to amprenavir; or if you||
2330|133|P|have any other allergies. This product may contain inactive||
2330|134|P|ingredients (such as propylene glycol in the suspension), which||
2330|135|P|can cause allergic reactions or other problems. Talk to your||
2330|136|P|pharmacist for more details.||
2330|137|P|   Before using this medication, tell your doctor or pharmacist||
2330|138|P|your medical history, especially of: liver problems (including||
2330|139|P|hepatitis B or C infections), kidney problems (including kidney||
2330|140|P|stones), heart problems (such as coronary artery disease, heart||
2330|141|P|attack), diabetes, a certain bleeding problem (hemophilia).||
2330|142|P|   Fosamprenavir may increase the level of cholesterol and fats||
2330|143|P|(triglycerides) in your blood. HIV infection can also cause this||
2330|144|P|effect. This could increase your risk for heart problems such as||
2330|145|P|a heart attack. Discuss the risks and benefits of treatment with||
2330|146|P|your doctor and ways to lower your risk of heart disease. Tell||
2330|147|P|your doctor if you have heart problems, if you smoke, or if you||
2330|148|P|have other conditions that increase your risk of heart disease||
2330|149|P|such as high blood pressure, diabetes, or high||
2330|150|P|cholesterol/triglyceride levels.||
2330|151|P|   Before having surgery, tell your doctors or dentist about all||
2330|152|P|the products you use (including prescription drugs,||
2330|153|P|nonprescription drugs, and herbal products).||
2330|154|P|   Children may be more sensitive to the side effects of this||
2330|155|P|drug, especially vomiting and signs of infection (such as sore||
2330|156|P|throat that doesn't go away, fever).||
2330|157|P|   During pregnancy, this medication should be used only when||
2330|158|P|clearly needed. Treatment can lower the risk of passing HIV||
2330|159|P|infection to your baby, and fosamprenavir may be part of that||
2330|160|P|treatment. Discuss the risks and benefits with your doctor.||
2330|161|P|   It is unknown if this medication passes into breast milk.||
2330|162|P|Because breast milk may transmit HIV, consult your doctor before||
2330|163|P|breastfeeding.||
2330|164|B|||
2330|165|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2330|166|I|medications work or increase your risk for serious side effects.||
2330|167|I|This document does not contain all possible drug interactions.||
2330|168|I|Keep a list of all the products you use (including||
2330|169|I|prescription/nonprescription drugs and herbal products) and share||
2330|170|I|it with your doctor and pharmacist. Do not start, stop, or change||
2330|171|I|the dosage of any medicines without your doctor's approval.||
2330|172|I|   Some products that may interact with this drug include:||
2330|173|I|certain HIV protease inhibitors (such as lopinavir, tipranavir),||
2330|174|I|orlistat.||
2330|175|I|   Other medications can affect the removal of fosamprenavir from||
2330|176|I|your body, which may affect how fosamprenavir works. Examples||
2330|177|I|include apalutamide, etravirine, rifampin, St. John's wort, among||
2330|178|I|others.||
2330|179|I|   Fosamprenavir can speed up or slow down the removal of other||
2330|180|I|medications from your body, which may affect how they work.||
2330|181|I|Examples of affected drugs include alpha blockers (such as||
2330|182|I|alfuzosin), certain benzodiazepines (midazolam, triazolam), ergot||
2330|183|I|alkaloids (such as dihydroergotamine, ergotamine), fluticasone,||
2330|184|I|pimozide, ranolazine, rivaroxaban, drugs to treat erectile||
2330|185|I|dysfunction-ED or pulmonary hypertension (such as sildenafil,||
2330|186|I|vardenafil), certain drugs to treat irregular heartbeat (such as||
2330|187|I|flecainide, propafenone), certain "statin" cholesterol drugs||
2330|188|I|(lovastatin, simvastatin), salmeterol, among others.||
2330|189|I|   This medication may decrease the effectiveness of hormonal||
2330|190|I|birth control such as pills, patch, or ring. This could cause||
2330|191|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2330|192|I|use reliable backup birth control methods while using this||
2330|193|I|medication. Also tell your doctor if you have any new spotting or||
2330|194|I|breakthrough bleeding, because these may be signs that your birth||
2330|195|I|control is not working well.||
2330|196|B|||
2330|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2330|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2330|199|O|poison control center right away. US residents can call||
2330|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2330|201|B|||
2330|202|N|NOTES:  Do not share this medication with others.||
2330|203|N|   Lab and/or medical tests (such as viral load, T-cell counts,||
2330|204|N|liver function, cholesterol/triglyceride levels, blood sugar||
2330|205|N|levels) should be done while you are taking this medication. Keep||
2330|206|N|all medical and lab appointments. Consult your doctor for more||
2330|207|N|details.||
2330|208|B|||
2330|209|D|MISSED DOSE:  It is important not to miss doses of this drug. If||
2330|210|D|you miss a dose, take it as soon as you remember. If it is more||
2330|211|D|than 4 hours after the missed dose, skip the missed dose. Take||
2330|212|D|your next dose at the regular time. Do not double the dose to||
2330|213|D|catch up.||
2330|214|B|||
2330|215|R|STORAGE:  Store the tablets at room temperature away from light||
2330|216|R|and moisture. Store the suspension at room temperature or in the||
2330|217|R|refrigerator. Refrigeration may improve the taste of the||
2330|218|R|suspension. Do not freeze. Do not store in the bathroom. Keep all||
2330|219|R|medications away from children and pets.||
2330|220|R|   Do not flush medications down the toilet or pour them into a||
2330|221|R|drain unless instructed to do so. Properly discard this product||
2330|222|R|when it is expired or no longer needed. Consult your pharmacist||
2330|223|R|or local waste disposal company.||
2330|224|B|||
2330|225|A|Information last revised April 2025.||
2330|226|A|Copyright(c) 2025 First Databank, Inc.||
2330|227|B|||
2331|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2331|002|Z|does NOT have all possible information about this product. This||
2331|003|Z|information does not assure that this product is safe, effective,||
2331|004|Z|or appropriate for you. This information is not individual||
2331|005|Z|medical advice and does not substitute for the advice of your||
2331|006|Z|health care professional. Always ask your health care||
2331|007|Z|professional for complete information about this product and your||
2331|008|Z|specific health needs.||
2331|009|B|||
2331|010|T|VIBEGRON - ORAL||
2331|011|F|(vye-BEG-ron)||
2331|012|B|||
2331|013|C|COMMON BRAND NAME(S): Gemtesa||
2331|014|B|||
2331|015|U|USES:  This medication is used to treat overactive bladder.||
2331|016|U|Overactive bladder is a problem with how your bladder stores||
2331|017|U|urine that causes a sudden urge to urinate. The urge may be hard||
2331|018|U|to control, and overactive bladder symptoms may include frequent||
2331|019|U|urination, strong sudden urges to urinate, or involuntary loss of||
2331|020|U|urine (incontinence). Vibegron works by relaxing a certain||
2331|021|U|bladder muscle (detrusor), which helps the bladder hold more||
2331|022|U|urine and lessens symptoms of overactive bladder.||
2331|023|B|||
2331|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2331|025|H|from your pharmacist before you start taking vibegron and each||
2331|026|H|time you get a refill. If you have any questions, ask your doctor||
2331|027|H|or pharmacist.||
2331|028|H|   Take this medication by mouth with or without food as directed||
2331|029|H|by your doctor, usually once daily. Swallow this medication whole||
2331|030|H|with a glass of water.||
2331|031|H|   If you have trouble swallowing the tablet, you may crush the||
2331|032|H|tablet and mix with 1 tablespoonful (15 milliliters) of||
2331|033|H|applesauce. Take the mixture right away with a glass of water. Do||
2331|034|H|not save the mixture for future use.||
2331|035|H|   The dosage is based on your medical condition and response to||
2331|036|H|treatment.||
2331|037|H|   Use this medication regularly to get the most benefit from it.||
2331|038|H|To help you remember, take it at the same time each day.||
2331|039|H|   Tell your doctor if your condition does not get better or if||
2331|040|H|it gets worse.||
2331|041|B|||
2331|042|S|SIDE EFFECTS:  Headache, nausea, or diarrhea may occur. If any of||
2331|043|S|these effects last or get worse, tell your doctor or pharmacist||
2331|044|S|promptly.||
2331|045|S|   Remember that this medication has been prescribed because your||
2331|046|S|doctor has judged that the benefit to you is greater than the||
2331|047|S|risk of side effects. Many people using this medication do not||
2331|048|S|have serious side effects.||
2331|049|S|   Tell your doctor right away if you have any serious side||
2331|050|S|effects, including: being unable to empty your bladder (urinary||
2331|051|S|retention).||
2331|052|S|   A very serious allergic reaction to this drug is rare.||
2331|053|S|However, get medical help right away if you notice any symptoms||
2331|054|S|of a serious allergic reaction, including: rash, itching/swelling||
2331|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2331|056|S|breathing.||
2331|057|S|   This is not a complete list of possible side effects. If you||
2331|058|S|notice other effects not listed above, contact your doctor or||
2331|059|S|pharmacist.||
2331|060|S|   In the US -||
2331|061|S|   Call your doctor for medical advice about side effects. You||
2331|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2331|063|S|www.fda.gov/medwatch.||
2331|064|S|   In Canada - Call your doctor for medical advice about side||
2331|065|S|effects. You may report side effects to Health Canada at||
2331|066|S|1-866-234-2345.||
2331|067|B|||
2331|068|P|PRECAUTIONS:  Before taking vibegron, tell your doctor or||
2331|069|P|pharmacist if you are allergic to it; or if you have any other||
2331|070|P|allergies. This product may contain inactive ingredients, which||
2331|071|P|can cause allergic reactions or other problems. Talk to your||
2331|072|P|pharmacist for more details.||
2331|073|P|   Before using this medication, tell your doctor or pharmacist||
2331|074|P|your medical history, especially of: other bladder problems (such||
2331|075|P|as blockage), kidney problems, liver problems.||
2331|076|P|   Before having surgery, tell your doctor or dentist about all||
2331|077|P|the products you use (including prescription drugs,||
2331|078|P|nonprescription drugs, and herbal products).||
2331|079|P|   During pregnancy, this medication should be used only when||
2331|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
2331|081|P|   It is unknown if this medication passes into breast milk.||
2331|082|P|Consult your doctor before breastfeeding.||
2331|083|B|||
2331|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2331|085|I|medications work or increase your risk for serious side effects.||
2331|086|I|This document does not contain all possible drug interactions.||
2331|087|I|Keep a list of all the products you use (including||
2331|088|I|prescription/nonprescription drugs and herbal products) and share||
2331|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
2331|090|I|the dosage of any medicines without your doctor's approval.||
2331|091|B|||
2331|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2331|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2331|094|O|poison control center right away. US residents can call||
2331|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2331|096|B|||
2331|097|N|NOTES:  Do not share this medication with others.||
2331|098|B|||
2331|099|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2331|100|D|remember. If it is near the time of the next dose, skip the||
2331|101|D|missed dose. Take your next dose at the regular time. Do not||
2331|102|D|double the dose to catch up.||
2331|103|B|||
2331|104|R|STORAGE:  Store at room temperature away from light and moisture.||
2331|105|R|Do not store in the bathroom. Keep all medications away from||
2331|106|R|children and pets.||
2331|107|R|   Do not flush medications down the toilet or pour them into a||
2331|108|R|drain unless instructed to do so. Properly discard this product||
2331|109|R|when it is expired or no longer needed. Consult your pharmacist||
2331|110|R|or local waste disposal company.||
2331|111|B|||
2331|112|A|Information last revised May 2024.||
2331|113|A|Copyright(c) 2025 First Databank, Inc.||
2331|114|B|||
2332|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2332|002|Z|does NOT have all possible information about this product. This||
2332|003|Z|information does not assure that this product is safe, effective,||
2332|004|Z|or appropriate for you. This information is not individual||
2332|005|Z|medical advice and does not substitute for the advice of your||
2332|006|Z|health care professional. Always ask your health care||
2332|007|Z|professional for complete information about this product and your||
2332|008|Z|specific health needs.||
2332|009|B|||
2332|010|T|BUDESONIDE TABLET - ORAL||
2332|011|F|(bue-DES-oh-nide)||
2332|012|B|||
2332|013|C|COMMON BRAND NAME(S): Uceris||
2332|014|B|||
2332|015|U|USES:  This medication is used to treat a certain bowel condition||
2332|016|U|(ulcerative colitis). While budesonide does not cure this||
2332|017|U|condition, it may decrease symptoms such as pain and diarrhea.||
2332|018|U|Budesonide is an anti-inflammatory drug (corticosteroid hormone).||
2332|019|U|It works by decreasing the body's natural defense response||
2332|020|U|(immune response).||
2332|021|B|||
2332|022|V|OTHER USES:  This section contains uses of this drug that are not||
2332|023|V|listed in the approved professional labeling for the drug but||
2332|024|V|that may be prescribed by your health care professional. Use this||
2332|025|V|drug for a condition that is listed in this section only if it||
2332|026|V|has been so prescribed by your health care professional.||
2332|027|V|   This medication may also be used for Crohn's disease.||
2332|028|B|||
2332|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2332|030|H|from your pharmacist before you start taking budesonide and each||
2332|031|H|time you get a refill. If you have any questions, ask your doctor||
2332|032|H|or pharmacist.||
2332|033|H|   Take this medication by mouth with or without food as directed||
2332|034|H|by your doctor, usually once daily in the morning. Swallow this||
2332|035|H|medication whole with a full glass of water (8 ounces/240||
2332|036|H|milliliters) unless your doctor directs you otherwise. Do not||
2332|037|H|crush or chew the tablets. Doing so can release all of the drug||
2332|038|H|at once, increasing the risk of side effects.||
2332|039|H|   The dosage and length of treatment are based on your medical||
2332|040|H|condition and response to treatment.||
2332|041|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2332|042|H|using this medication unless your doctor or pharmacist says you||
2332|043|H|may do so safely. Grapefruit can increase the chance of side||
2332|044|H|effects with this medicine. Ask your doctor or pharmacist for||
2332|045|H|more details.||
2332|046|H|   If you are regularly taking a different corticosteroid by||
2332|047|H|mouth (such as prednisone), you should not stop taking it unless||
2332|048|H|directed by your doctor. Some conditions (such as asthma,||
2332|049|H|allergies) may become worse when the drug is suddenly stopped. If||
2332|050|H|you suddenly stop taking the drug, you may also have withdrawal||
2332|051|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
2332|052|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
2332|053|H|doctor may slowly lower the dose of your old medication after you||
2332|054|H|begin taking budesonide. Tell your doctor or pharmacist right||
2332|055|H|away if you have withdrawal. See also Precautions section.||
2332|056|H|   Use this medication regularly to get the most benefit from it.||
2332|057|H|To help you remember, take it at the same time each day. Do not||
2332|058|H|increase your dose or use this drug more often or for longer than||
2332|059|H|prescribed. Your condition will not improve any faster, and your||
2332|060|H|risk of side effects will increase.||
2332|061|H|   Do not stop taking this medication without consulting your||
2332|062|H|doctor. Some conditions may become worse when this drug is||
2332|063|H|suddenly stopped. Your dose may need to be gradually decreased.||
2332|064|H|   Tell your doctor if your condition does not get better or if||
2332|065|H|it gets worse.||
2332|066|B|||
2332|067|S|SIDE EFFECTS:  This medication usually has fewer side effects||
2332|068|S|than other corticosteroids because budesonide works in the gut||
2332|069|S|and only small amounts are absorbed into the body. Nausea,||
2332|070|S|abdominal pain, or headache may occur. If any of these effects||
2332|071|S|last or get worse, tell your doctor or pharmacist promptly.||
2332|072|S|   Remember that this medication has been prescribed because your||
2332|073|S|doctor has judged that the benefit to you is greater than the||
2332|074|S|risk of side effects. Many people using this medication do not||
2332|075|S|have serious side effects.||
2332|076|S|   Because this drug works by weakening the immune system, it may||
2332|077|S|lower your ability to fight infections. This may make you more||
2332|078|S|likely to get a serious (rarely fatal) infection or make any||
2332|079|S|infection you have worse. Tell your doctor right away if you have||
2332|080|S|any signs of infection (such as sore throat that doesn't go away,||
2332|081|S|fever, chills). This medication may sometimes cause oral thrush||
2332|082|S|or a new yeast infection. Contact your doctor if you notice white||
2332|083|S|patches in your mouth, a change in vaginal discharge, or other||
2332|084|S|new symptoms.||
2332|085|S|   Tell your doctor right away if you have any serious side||
2332|086|S|effects, including: easy bruising/bleeding, puffy face, unusual||
2332|087|S|weight gain, menstrual period changes, mental/mood changes (such||
2332|088|S|as depression, mood swings, agitation), muscle weakness/pain,||
2332|089|S|bone pain, thinning skin, slow wound healing, increased||
2332|090|S|thirst/urination, vision problems, symptoms of stomach/intestinal||
2332|091|S|bleeding (such as stomach/abdominal pain, black/tarry stools,||
2332|092|S|vomit that looks like coffee grounds), red/purple spots on the||
2332|093|S|skin.||
2332|094|S|   A very serious allergic reaction to this drug is rare.||
2332|095|S|However, get medical help right away if you notice any symptoms||
2332|096|S|of a serious allergic reaction, including: rash, itching/swelling||
2332|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2332|098|S|breathing.||
2332|099|S|   This is not a complete list of possible side effects. If you||
2332|100|S|notice other effects not listed above, contact your doctor or||
2332|101|S|pharmacist.||
2332|102|S|   In the US -||
2332|103|S|   Call your doctor for medical advice about side effects. You||
2332|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2332|105|S|www.fda.gov/medwatch.||
2332|106|S|   In Canada - Call your doctor for medical advice about side||
2332|107|S|effects. You may report side effects to Health Canada at||
2332|108|S|1-866-234-2345.||
2332|109|B|||
2332|110|P|PRECAUTIONS:  Before taking budesonide, tell your doctor if you||
2332|111|P|are allergic to it; or if you have any other allergies. This||
2332|112|P|product may contain inactive ingredients, which can cause||
2332|113|P|allergic reactions or other problems. Talk to your pharmacist for||
2332|114|P|more details.||
2332|115|P|   Before using this medication, tell your doctor or pharmacist||
2332|116|P|your medical history, especially of: eye problems (such as||
2332|117|P|cataracts, glaucoma), high blood pressure, liver problems (such||
2332|118|P|as hepatitis B), diabetes, stomach/intestinal problems (such as||
2332|119|P|diverticulitis, ulcer), bone loss (osteoporosis), current/past||
2332|120|P|infections (such as tuberculosis, herpes), bleeding problems,||
2332|121|P|mental/mood problems (such as psychosis, anxiety, depression), a||
2332|122|P|certain adrenal gland tumor (pheochromocytoma).||
2332|123|P|   Using corticosteroid medications for a long time can make it||
2332|124|P|more difficult for your body to respond to physical stress.||
2332|125|P|Before having surgery or emergency treatment, or if you get a||
2332|126|P|serious illness/injury, tell your doctor or dentist that you are||
2332|127|P|using this medication or have used this medication within the||
2332|128|P|past 12 months. Tell your doctor right away if you develop||
2332|129|P|unusual/extreme tiredness or weight loss. If you will be using||
2332|130|P|this medication for a long time, carry a warning card or medical||
2332|131|P|ID bracelet that identifies your use of this medication.||
2332|132|P|   Before having surgery, tell your doctor or dentist about all||
2332|133|P|the products you use (including prescription drugs,||
2332|134|P|nonprescription drugs, and herbal products).||
2332|135|P|   Daily use of alcohol while using this medicine may increase||
2332|136|P|your risk for stomach bleeding. Limit alcoholic beverages.||
2332|137|P|Consult your doctor or pharmacist for more information.||
2332|138|P|   This medication can make you more likely to get infections or||
2332|139|P|may make current infections worse. Stay away from anyone who has||
2332|140|P|an infection that may easily spread (such as chickenpox,||
2332|141|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2332|142|P|exposed to an infection or for more details.||
2332|143|P|   Tell your health care professional that you are using||
2332|144|P|budesonide before having any immunizations/vaccinations. Avoid||
2332|145|P|contact with people who have recently received live vaccines||
2332|146|P|(such as flu vaccine inhaled through the nose).||
2332|147|P|   Older adults may be more sensitive to the side effects of this||
2332|148|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
2332|149|P|mental/mood changes (such as confusion).||
2332|150|P|   This medication may slow down a child's growth if used for a||
2332|151|P|long time. Consult the doctor or pharmacist for more details. See||
2332|152|P|the doctor regularly so your child's height and growth can be||
2332|153|P|checked.||
2332|154|P|   During pregnancy, this medication should be used only when||
2332|155|P|clearly needed. Discuss the risks and benefits with your doctor.||
2332|156|P|Babies born to mothers who have used corticosteroids for a long||
2332|157|P|time may develop hormone problems. Tell your doctor right away if||
2332|158|P|you notice symptoms such as nausea/vomiting that doesn't stop,||
2332|159|P|severe diarrhea, or weakness in your newborn.||
2332|160|P|   This medication passes into breast milk. Consult your doctor||
2332|161|P|before breastfeeding.||
2332|162|B|||
2332|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2332|164|I|medications work or increase your risk for serious side effects.||
2332|165|I|This document does not contain all possible drug interactions.||
2332|166|I|Keep a list of all the products you use (including||
2332|167|I|prescription/nonprescription drugs and herbal products) and share||
2332|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
2332|169|I|the dosage of any medicines without your doctor's approval.||
2332|170|I|   Some products that may interact with this drug are:||
2332|171|I|aldesleukin, desmopressin, mifepristone, drugs that can cause||
2332|172|I|bleeding/bruising (including antiplatelet drugs such as||
2332|173|I|clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs||
2332|174|I|such as aspirin/celecoxib/ibuprofen).||
2332|175|I|   If your doctor has told you to take low-dose aspirin to||
2332|176|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
2332|177|I|you should keep taking the aspirin unless your doctor tells you||
2332|178|I|not to. Ask your doctor or pharmacist for more details.||
2332|179|I|   This product may interfere with certain lab tests (such as||
2332|180|I|skin tests), possibly causing false test results. Make sure lab||
2332|181|I|personnel and all your doctors know you use this drug.||
2332|182|B|||
2332|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2332|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2332|185|O|poison control center right away. US residents can call||
2332|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2332|187|B|||
2332|188|N|NOTES:  Do not share this medication with others.||
2332|189|N|   If this medication is used for a long time, lab and/or medical||
2332|190|N|tests (such as blood count, bone density, eye exams,||
2332|191|N|height/weight measurements) may be done while you are taking it.||
2332|192|N|Keep all medical and lab appointments. Consult your doctor for||
2332|193|N|more details.||
2332|194|N|   This medication may cause bone loss (osteoporosis) when used||
2332|195|N|for a long time. Lifestyle changes that may help reduce the risk||
2332|196|N|of bone problems include doing weight-bearing exercise, stopping||
2332|197|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2332|198|N|D. Talk to your doctor for more details.||
2332|199|B|||
2332|200|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2332|201|D|remember. If it is near the time of the next dose, skip the||
2332|202|D|missed dose. Take your next dose at the regular time. Do not||
2332|203|D|double the dose to catch up.||
2332|204|B|||
2332|205|R|STORAGE:  Store at room temperature away from light and moisture.||
2332|206|R|Do not store in the bathroom. Keep all medications away from||
2332|207|R|children and pets.||
2332|208|R|   Do not flush medications down the toilet or pour them into a||
2332|209|R|drain unless instructed to do so. Properly discard this product||
2332|210|R|when it is expired or no longer needed. Consult your pharmacist||
2332|211|R|or local waste disposal company.||
2332|212|B|||
2332|213|M|MEDICAL ALERT:  Your condition can cause complications in a||
2332|214|M|medical emergency. For information about enrolling in MedicAlert,||
2332|215|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2332|216|B|||
2332|217|A|Information last revised September 2025.||
2332|218|A|Copyright(c) 2025 First Databank, Inc.||
2332|219|B|||
2333|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2333|002|Z|does NOT have all possible information about this product. This||
2333|003|Z|information does not assure that this product is safe, effective,||
2333|004|Z|or appropriate for you. This information is not individual||
2333|005|Z|medical advice and does not substitute for the advice of your||
2333|006|Z|health care professional. Always ask your health care||
2333|007|Z|professional for complete information about this product and your||
2333|008|Z|specific health needs.||
2333|009|B|||
2333|010|T|PREDNISOLONE LIQUID - ORAL||
2333|011|F|(pred-NIS-oh-loan)||
2333|012|B|||
2333|013|C|COMMON BRAND NAME(S): Orapred, Pediapred, Prelone||
2333|014|B|||
2333|015|U|USES:  Prednisolone is a man-made form of a natural substance||
2333|016|U|(corticosteroid hormone) made by the adrenal gland. It is used to||
2333|017|U|treat conditions such as arthritis, blood problems, immune system||
2333|018|U|disorders, skin and eye conditions, breathing problems, cancer,||
2333|019|U|and severe allergies. It decreases your immune system's response||
2333|020|U|to various diseases to reduce symptoms such as pain, swelling and||
2333|021|U|allergic-type reactions.||
2333|022|B|||
2333|023|H|HOW TO USE:  Take this medication by mouth, with food or milk to||
2333|024|H|prevent stomach upset, exactly as directed by your doctor.||
2333|025|H|Carefully measure the dose using a special measuring||
2333|026|H|device/spoon. Do not use a household spoon because you may not||
2333|027|H|get the correct dose.||
2333|028|H|   There are many brands, strengths, and forms of liquid||
2333|029|H|prednisolone available. Read the dosing instructions carefully||
2333|030|H|for each product because the amount of prednisolone may be||
2333|031|H|different between products. See also Precautions and Storage||
2333|032|H|sections.||
2333|033|H|   Follow the dosing schedule carefully. The dosage and length of||
2333|034|H|treatment are based on your medical condition and response to||
2333|035|H|treatment. Your doctor may direct you to take prednisolone 1 to 4||
2333|036|H|times a day or take a single dose every other day. To help you||
2333|037|H|remember, mark your calendar with a reminder.||
2333|038|H|   Do not stop taking this medication without consulting your||
2333|039|H|doctor. Some conditions may become worse when this drug is||
2333|040|H|suddenly stopped. Your dose may need to be gradually decreased.||
2333|041|H|   If you suddenly stop using this medication, you may have||
2333|042|H|withdrawal symptoms (such as weakness, weight loss, nausea,||
2333|043|H|muscle pain, headache, tiredness, dizziness). To help prevent||
2333|044|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
2333|045|H|more likely if you have used prednisolone for a long time or in||
2333|046|H|high doses. Tell your doctor or pharmacist right away if you have||
2333|047|H|withdrawal. See also Precautions section.||
2333|048|H|   Tell your doctor if your condition lasts or gets worse.||
2333|049|B|||
2333|050|S|SIDE EFFECTS:  Nausea, heartburn, headache, dizziness, menstrual||
2333|051|S|period changes, trouble sleeping, increased sweating, or acne may||
2333|052|S|occur. If any of these effects last or get worse, tell your||
2333|053|S|doctor or pharmacist promptly.||
2333|054|S|   Remember that this medication has been prescribed because your||
2333|055|S|doctor has judged that the benefit to you is greater than the||
2333|056|S|risk of side effects. Many people using this medication do not||
2333|057|S|have serious side effects.||
2333|058|S|   Because this drug works by weakening the immune system, it may||
2333|059|S|lower your ability to fight infections. This may make you more||
2333|060|S|likely to get a serious (rarely fatal) infection or make any||
2333|061|S|infection you have worse. Tell your doctor right away if you have||
2333|062|S|any signs of infection (such as sore throat that doesn't go away,||
2333|063|S|fever, chills). Use of this medication for prolonged or repeated||
2333|064|S|periods may result in oral thrush or a yeast infection. Contact||
2333|065|S|your doctor if you notice white patches in your mouth or a change||
2333|066|S|in vaginal discharge.||
2333|067|S|   This medication may rarely make your blood sugar rise, which||
2333|068|S|can cause or worsen diabetes. Tell your doctor right away if you||
2333|069|S|have symptoms of high blood sugar such as increased||
2333|070|S|thirst/urination. If you already have diabetes, check your blood||
2333|071|S|sugar regularly as directed and share the results with your||
2333|072|S|doctor. Your doctor may need to adjust your diabetes medication,||
2333|073|S|exercise program, or diet.||
2333|074|S|   Tell your doctor right away if you have any serious side||
2333|075|S|effects, including: unusual tiredness, swelling ankles/feet,||
2333|076|S|unusual weight gain, vision problems, easy bruising/bleeding,||
2333|077|S|puffy face, unusual hair growth, mental/mood changes (such as||
2333|078|S|depression, mood swings, agitation), muscle weakness/pain,||
2333|079|S|thinning skin, slow wound healing, bone pain, symptoms of||
2333|080|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
2333|081|S|black/tarry stools, vomit that looks like coffee grounds),||
2333|082|S|red/purple spots on the skin.||
2333|083|S|   Get medical help right away if you have any very serious side||
2333|084|S|effects, including: chest pain, seizures.||
2333|085|S|   A very serious allergic reaction to this drug is rare.||
2333|086|S|However, get medical help right away if you notice any symptoms||
2333|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2333|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2333|089|S|breathing.||
2333|090|S|   This is not a complete list of possible side effects. If you||
2333|091|S|notice other effects not listed above, contact your doctor or||
2333|092|S|pharmacist.||
2333|093|S|   In the US -||
2333|094|S|   Call your doctor for medical advice about side effects. You||
2333|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2333|096|S|www.fda.gov/medwatch.||
2333|097|S|   In Canada - Call your doctor for medical advice about side||
2333|098|S|effects. You may report side effects to Health Canada at||
2333|099|S|1-866-234-2345.||
2333|100|B|||
2333|101|P|PRECAUTIONS:  Before taking prednisolone, tell your doctor or||
2333|102|P|pharmacist if you are allergic to it; or to prednisone; or if you||
2333|103|P|have any other allergies. This product may contain inactive||
2333|104|P|ingredients, which can cause allergic reactions or other||
2333|105|P|problems. Talk to your pharmacist for more details.||
2333|106|P|   Before using this medication, tell your doctor or pharmacist||
2333|107|P|your medical history, especially of: eye disease (such as||
2333|108|P|cataracts, glaucoma), heart problems (such as heart failure,||
2333|109|P|recent heart attack), high blood pressure, liver disease (such as||
2333|110|P|hepatitis B), kidney disease, thyroid problems, diabetes,||
2333|111|P|stomach/intestinal problems (such as diverticulitis, ulcer),||
2333|112|P|brittle bones (osteoporosis), current/past infections (such as||
2333|113|P|tuberculosis, positive tuberculosis test, herpes, fungal),||
2333|114|P|bleeding problems, blood clots, certain mental/mood conditions||
2333|115|P|(such as psychosis, anxiety, depression), low salts in the blood||
2333|116|P|(such as low potassium or calcium), seizures, a certain adrenal||
2333|117|P|gland tumor (pheochromocytoma).||
2333|118|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2333|119|P|can make you more dizzy. Do not drive, use machinery, or do||
2333|120|P|anything that needs alertness until you can do it safely. Limit||
2333|121|P|alcoholic beverages. Talk to your doctor if you are using||
2333|122|P|marijuana (cannabis).||
2333|123|P|   This medication may cause stomach bleeding. Daily use of||
2333|124|P|alcohol while using this medication may increase your risk for||
2333|125|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
2333|126|P|or pharmacist for more information.||
2333|127|P|   Before having surgery, tell your doctor or dentist about all||
2333|128|P|the products you use (including prescription drugs,||
2333|129|P|nonprescription drugs, and herbal products).||
2333|130|P|   This product may contain alcohol, sugar, and/or aspartame.||
2333|131|P|Caution is advised if you have diabetes, alcohol dependence,||
2333|132|P|liver disease, phenylketonuria (PKU), or any other condition that||
2333|133|P|requires you to limit/avoid these substances in your diet. Ask||
2333|134|P|your doctor or pharmacist about using this product safely.||
2333|135|P|   Using corticosteroid medications for a long time can make it||
2333|136|P|more difficult for your body to respond to physical stress.||
2333|137|P|Before having surgery or emergency treatment, or if you get a||
2333|138|P|serious illness/injury, tell your doctor or dentist that you are||
2333|139|P|using this medication or have used this medication within the||
2333|140|P|past 12 months. Tell your doctor right away if you develop||
2333|141|P|unusual/extreme tiredness or weight loss. If you will be using||
2333|142|P|this medication for a long time, carry a warning card or medical||
2333|143|P|ID bracelet that identifies your use of this medication.||
2333|144|P|   This medication may mask signs of infection. It can make you||
2333|145|P|more likely to get infections or may make current infections||
2333|146|P|worse. Stay away from anyone who has an infection that may easily||
2333|147|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2333|148|P|doctor if you have been exposed to an infection or for more||
2333|149|P|details.||
2333|150|P|   Tell your health care professional that you are using||
2333|151|P|prednisolone before having any immunizations/vaccinations. Avoid||
2333|152|P|contact with people who have recently received live vaccines||
2333|153|P|(such as flu vaccine inhaled through the nose).||
2333|154|P|   This medication may slow down a child's growth if used for a||
2333|155|P|long time. Consult the doctor or pharmacist for more details. See||
2333|156|P|the doctor regularly so your child's height and growth can be||
2333|157|P|checked.||
2333|158|P|   Older adults may be more sensitive to the effects of this||
2333|159|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
2333|160|P|mental/mood changes (such as confusion).||
2333|161|P|   During pregnancy, prednisolone should be used only when||
2333|162|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
2333|163|P|risks and benefits with your doctor. Infants born to mothers who||
2333|164|P|have been using this medication for an extended period of time||
2333|165|P|may have hormone problems. Tell your doctor right away if you||
2333|166|P|notice symptoms such as nausea/vomiting that doesn't stop, severe||
2333|167|P|diarrhea, or weakness in your newborn.||
2333|168|P|   This medication passes into breast milk. However, this drug is||
2333|169|P|unlikely to harm a nursing infant. Consult your doctor before||
2333|170|P|breastfeeding.||
2333|171|B|||
2333|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2333|173|I|medications work or increase your risk for serious side effects.||
2333|174|I|This document does not contain all possible drug interactions.||
2333|175|I|Keep a list of all the products you use (including||
2333|176|I|prescription/nonprescription drugs and herbal products) and share||
2333|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
2333|178|I|the dosage of any medicines without your doctor's approval.||
2333|179|I|   Some products that may interact with this drug include:||
2333|180|I|aldesleukin, desmopressin, other drugs that weaken the immune||
2333|181|I|system (such as azathioprine, cyclosporine, cancer chemotherapy),||
2333|182|I|mifepristone, drugs that can cause bleeding/bruising (including||
2333|183|I|antiplatelet drugs such as clopidogrel, "blood thinners" such as||
2333|184|I|dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen).||
2333|185|I|   Other medications can affect the removal of prednisolone from||
2333|186|I|your body, which may affect how prednisolone works. Examples||
2333|187|I|include estrogens, azole antifungals (such as itraconazole), St.||
2333|188|I|John's wort, drugs used to treat seizures (such as phenytoin),||
2333|189|I|among others.||
2333|190|I|   If your doctor has told you to take low-dose aspirin to||
2333|191|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
2333|192|I|you should keep taking the aspirin unless your doctor tells you||
2333|193|I|not to. Ask your doctor or pharmacist for more details.||
2333|194|I|   This medication may interfere with certain lab tests (such as||
2333|195|I|skin tests), possibly causing false test results. Make sure lab||
2333|196|I|personnel and all your doctors know you use this drug.||
2333|197|B|||
2333|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2333|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2333|200|O|poison control center right away. US residents can call||
2333|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2333|202|B|||
2333|203|N|NOTES:  Do not share this medication with others.||
2333|204|N|   If this medication is used for a long time, lab and/or medical||
2333|205|N|tests (such as blood sugar/mineral levels, blood counts, blood||
2333|206|N|pressure, bone density tests, eye exams, height/weight||
2333|207|N|measurements, X-rays) should be done while you are taking this||
2333|208|N|medication. Keep all medical and lab appointments. Consult your||
2333|209|N|doctor for more details.||
2333|210|N|   This medication may cause bone loss (osteoporosis) when used||
2333|211|N|for a long time. Lifestyle changes that may help reduce the risk||
2333|212|N|of bone problems include doing weight-bearing exercise, stopping||
2333|213|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2333|214|N|D. Talk to your doctor for more details.||
2333|215|B|||
2333|216|D|MISSED DOSE:  If you are taking this medication once daily and||
2333|217|D|miss a dose, take it as soon as you remember. If it is near the||
2333|218|D|time of the next dose, skip the missed dose. Take your next dose||
2333|219|D|at the regular time. If you are taking this medication every||
2333|220|D|other day, ask your doctor or pharmacist what you should do if||
2333|221|D|you miss a dose.||
2333|222|B|||
2333|223|R|STORAGE:  Different brands of this medication have different||
2333|224|R|storage needs. Check the product package for instructions on how||
2333|225|R|to store your brand, or ask your pharmacist. Keep all medications||
2333|226|R|away from children and pets.||
2333|227|R|   Do not flush medications down the toilet or pour them into a||
2333|228|R|drain unless instructed to do so. Properly discard this product||
2333|229|R|when it is expired or no longer needed. Consult your pharmacist||
2333|230|R|or local waste disposal company.||
2333|231|B|||
2333|232|M|MEDICAL ALERT:  Your condition can cause complications in a||
2333|233|M|medical emergency. For information about enrolling in MedicAlert,||
2333|234|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2333|235|B|||
2333|236|A|Information last revised September 2025.||
2333|237|A|Copyright(c) 2025 First Databank, Inc.||
2333|238|B|||
2334|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2334|002|Z|does NOT have all possible information about this product. This||
2334|003|Z|information does not assure that this product is safe, effective,||
2334|004|Z|or appropriate for you. This information is not individual||
2334|005|Z|medical advice and does not substitute for the advice of your||
2334|006|Z|health care professional. Always ask your health care||
2334|007|Z|professional for complete information about this product and your||
2334|008|Z|specific health needs.||
2334|009|B|||
2334|010|T|TIRBANIBULIN - TOPICAL||
2334|011|F|(TIR-ban-i-BUE-lin)||
2334|012|B|||
2334|013|C|COMMON BRAND NAME(S): Klisyri||
2334|014|B|||
2334|015|U|USES:  This medication is used to treat a certain skin condition||
2334|016|U|(actinic keratosis) on the face or scalp area.||
2334|017|B|||
2334|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2334|019|H|from your pharmacist before you start using tirbanibulin and each||
2334|020|H|time you get a refill. If you have any questions, ask your doctor||
2334|021|H|or pharmacist.||
2334|022|H|   Use this medication on the skin only. Wash and dry your hands||
2334|023|H|before applying the medication. Apply enough medication to cover||
2334|024|H|the affected skin on the face or scalp as directed by your||
2334|025|H|doctor, usually once a day for 5 days in a row. Use a new packet||
2334|026|H|for each application. Wash your hands with soap and water after||
2334|027|H|using to avoid getting the medication in your eyes or on other||
2334|028|H|areas of your body. Do not cover the treated area with bandages||
2334|029|H|or other dressings.||
2334|030|H|   Avoid washing or touching the treated area for about 8 hours||
2334|031|H|after applying the medication. After about 8 hours, you may then||
2334|032|H|wash the area with water and a mild soap.||
2334|033|H|   Do not increase your dose or use this drug more often or for||
2334|034|H|longer than prescribed. Your condition will not improve any||
2334|035|H|faster, and your risk of side effects will increase.||
2334|036|H|   Do not apply the medication in or around the eyes or mouth or||
2334|037|H|on any damaged skin or skin that is healing. If you do get the||
2334|038|H|medication in those areas, flush with plenty of water. Get||
2334|039|H|medical help right away if the medication gets into your eyes.||
2334|040|H|   Use this medication regularly to get the most benefit from it.||
2334|041|H|To help you remember, use it at the same time each day.||
2334|042|H|   Tell your doctor if your condition lasts or gets worse.||
2334|043|B|||
2334|044|S|SIDE EFFECTS:  Swelling, scaling/flaking, pain, itching, or||
2334|045|S|redness at the application site may occur. If any of these||
2334|046|S|effects last or get worse, tell your doctor or pharmacist||
2334|047|S|promptly.||
2334|048|S|   Remember that this medication has been prescribed because your||
2334|049|S|doctor has judged that the benefit to you is greater than the||
2334|050|S|risk of side effects. Many people using this medication do not||
2334|051|S|have serious side effects.||
2334|052|S|   Tell your doctor right away if you have any serious side||
2334|053|S|effects, including: pus/blister/ulcer at application site.||
2334|054|S|   A very serious allergic reaction to this drug is rare.||
2334|055|S|However, get medical help right away if you notice any symptoms||
2334|056|S|of a serious allergic reaction, including: rash, itching/swelling||
2334|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2334|058|S|breathing.||
2334|059|S|   This is not a complete list of possible side effects. If you||
2334|060|S|notice other effects not listed above, contact your doctor or||
2334|061|S|pharmacist.||
2334|062|S|   In the US -||
2334|063|S|   Call your doctor for medical advice about side effects. You||
2334|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2334|065|S|www.fda.gov/medwatch.||
2334|066|S|   In Canada - Call your doctor for medical advice about side||
2334|067|S|effects. You may report side effects to Health Canada at||
2334|068|S|1-866-234-2345.||
2334|069|B|||
2334|070|P|PRECAUTIONS:  Before using tirbanibulin, tell your doctor or||
2334|071|P|pharmacist if you are allergic to it; or if you have any other||
2334|072|P|allergies. This product may contain inactive ingredients, which||
2334|073|P|can cause allergic reactions or other problems. Talk to your||
2334|074|P|pharmacist for more details.||
2334|075|P|   Before using this medication, tell your doctor or pharmacist||
2334|076|P|your medical history.||
2334|077|P|   Before having surgery, tell your doctor or dentist about all||
2334|078|P|the products you use (including prescription drugs,||
2334|079|P|nonprescription drugs, and herbal products).||
2334|080|P|   Your condition may get worse when exposed to the sun. Limit||
2334|081|P|your time in the sun. Avoid tanning booths and sunlamps. Wear||
2334|082|P|protective clothing when outdoors. Ask your doctor if you should||
2334|083|P|use sunscreen along with this medication.||
2334|084|P|   During pregnancy, this medication should be used only when||
2334|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
2334|086|P|   It is unknown if this drug passes into breast milk. Consult||
2334|087|P|your doctor before breastfeeding.||
2334|088|B|||
2334|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2334|090|I|medications work or increase your risk for serious side effects.||
2334|091|I|This document does not contain all possible drug interactions.||
2334|092|I|Keep a list of all the products you use (including||
2334|093|I|prescription/nonprescription drugs and herbal products) and share||
2334|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
2334|095|I|the dosage of any medicines without your doctor's approval.||
2334|096|B|||
2334|097|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2334|098|O|has overdosed and has serious symptoms such as passing out or||
2334|099|O|trouble breathing, call 911. Otherwise, call a poison control||
2334|100|O|center right away. US residents can call 1-800-222-1222. Canada||
2334|101|O|residents can call 1-844-764-7669.||
2334|102|B|||
2334|103|N|NOTES:  Do not share this medication with others.||
2334|104|B|||
2334|105|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2334|106|D|If it is near the time of the next dose, skip the missed dose.||
2334|107|D|Use your next dose at the regular time. Do not double the dose to||
2334|108|D|catch up.||
2334|109|B|||
2334|110|R|STORAGE:  Store at room temperature. Do not refrigerate or||
2334|111|R|freeze. Discard the opened packet after each use. Keep all||
2334|112|R|medications away from children and pets.||
2334|113|R|   Do not flush medications down the toilet or pour them into a||
2334|114|R|drain unless instructed to do so. Properly discard this product||
2334|115|R|when it is expired or no longer needed. Consult your pharmacist||
2334|116|R|or local waste disposal company.||
2334|117|B|||
2334|118|A|Information last revised May 2024.||
2334|119|A|Copyright(c) 2025 First Databank, Inc.||
2334|120|B|||
2335|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2335|002|Z|does NOT have all possible information about this product. This||
2335|003|Z|information does not assure that this product is safe, effective,||
2335|004|Z|or appropriate for you. This information is not individual||
2335|005|Z|medical advice and does not substitute for the advice of your||
2335|006|Z|health care professional. Always ask your health care||
2335|007|Z|professional for complete information about this product and your||
2335|008|Z|specific health needs.||
2335|009|B|||
2335|010|T|BUDESONIDE DISPERSIBLE TABLET - ORAL||
2335|011|F|(bue-DES-oh-nide)||
2335|012|B|||
2335|013|U|USES:  This medication is used to treat a certain immune disorder||
2335|014|U|of the esophagus (eosinophilic esophagitis-EoE). The esophagus is||
2335|015|U|the tube that connects your mouth to your stomach. In EoE, a type||
2335|016|U|of white blood cell builds up in the esophagus and causes damage||
2335|017|U|that can lead to symptoms such as trouble swallowing, food||
2335|018|U|getting stuck when you swallow, chest discomfort, and backflow of||
2335|019|U|undigested food (regurgitation). Budesonide is an||
2335|020|U|anti-inflammatory drug (corticosteroid hormone). It works by||
2335|021|U|decreasing the body's natural defense response (immune response).||
2335|022|B|||
2335|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2335|024|H|from your pharmacist before you start taking budesonide and each||
2335|025|H|time you get a refill. If you have any questions, ask your doctor||
2335|026|H|or pharmacist.||
2335|027|H|   Make sure your hands are dry before you handle this||
2335|028|H|medication. Take this medication by mouth as directed by your||
2335|029|H|doctor, usually once in the morning and once in the evening,||
2335|030|H|after a meal both times. Do not take the tablet with liquid or||
2335|031|H|food. Place the tablet on the tip of your tongue and close your||
2335|032|H|mouth. Press the tablet against the roof of your mouth until it||
2335|033|H|has completely dissolved (this takes about 2 minutes). Swallow a||
2335|034|H|little at a time as it dissolves with your saliva. Do not chew or||
2335|035|H|swallow the undissolved tablet.||
2335|036|H|   To make sure this medication works properly, do not eat,||
2335|037|H|drink, brush your teeth, or rinse your mouth for at least 30||
2335|038|H|minutes after you have taken the tablet. Do not use any oral||
2335|039|H|solution, spray, or chewable tablets at least 30 minutes before||
2335|040|H|and after taking this medication.||
2335|041|H|   The dosage and length of treatment are based on your medical||
2335|042|H|condition and response to treatment.||
2335|043|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2335|044|H|using this medication unless your doctor or pharmacist says you||
2335|045|H|may do so safely. Grapefruit can increase the chance of side||
2335|046|H|effects with this medicine. Ask your doctor or pharmacist for||
2335|047|H|more details.||
2335|048|H|   If you are regularly using a different corticosteroid taken by||
2335|049|H|mouth (such as prednisone), you should not stop using it unless||
2335|050|H|directed by your doctor. You may have withdrawal symptoms if the||
2335|051|H|drug is suddenly stopped. Some conditions (such as asthma,||
2335|052|H|allergies) may become worse when the drug is suddenly stopped. To||
2335|053|H|prevent withdrawal symptoms (such as weakness, weight loss,||
2335|054|H|nausea, muscle pain, headache, tiredness, dizziness), your doctor||
2335|055|H|may direct you to slowly lower the dose of your old medication||
2335|056|H|after you begin using this product. Consult your doctor or||
2335|057|H|pharmacist for more details, and report any withdrawal reactions||
2335|058|H|right away. See also Precautions section.||
2335|059|H|   Use this medication regularly to get the most benefit from it.||
2335|060|H|To help you remember, take it at the same times each day. Do not||
2335|061|H|increase your dose or use this drug more often or for longer than||
2335|062|H|prescribed. Your condition will not improve any faster, and your||
2335|063|H|risk of side effects will increase.||
2335|064|H|   Do not stop taking this medication without consulting your||
2335|065|H|doctor. Some conditions may become worse when this drug is||
2335|066|H|suddenly stopped. Your dose may need to be gradually decreased.||
2335|067|H|   Tell your doctor if your condition does not get better or if||
2335|068|H|it gets worse.||
2335|069|B|||
2335|070|S|SIDE EFFECTS:  This medication usually has fewer side effects||
2335|071|S|than other corticosteroids because budesonide works in the||
2335|072|S|esophagus and only small amounts are absorbed into the body.||
2335|073|S|Tiredness and headache may occur. If either of these effects||
2335|074|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
2335|075|S|   Remember that this medication has been prescribed because your||
2335|076|S|doctor has judged that the benefit to you is greater than the||
2335|077|S|risk of side effects. Many people using this medication do not||
2335|078|S|have serious side effects.||
2335|079|S|   Because this drug works by weakening the immune system, it may||
2335|080|S|lower your ability to fight infections. This may make you more||
2335|081|S|likely to get a serious (rarely fatal) infection or make any||
2335|082|S|infection you have worse. Tell your doctor right away if you have||
2335|083|S|any signs of infection (such as sore throat that doesn't go away,||
2335|084|S|fever, chills).||
2335|085|S|   This medication may sometimes cause oral thrush or a new yeast||
2335|086|S|infection. Contact your doctor if you notice white patches in||
2335|087|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2335|088|S|   Tell your doctor right away if you have any serious side||
2335|089|S|effects, including: easy bruising/bleeding, puffy face, unusual||
2335|090|S|weight gain, menstrual period changes, mental/mood changes (such||
2335|091|S|as depression, mood swings, agitation), muscle weakness/pain,||
2335|092|S|bone pain, thinning skin, slow wound healing, increased||
2335|093|S|thirst/urination, vision problems, symptoms of stomach/intestinal||
2335|094|S|bleeding (such as stomach/abdominal pain, black/tarry stools,||
2335|095|S|vomit that looks like coffee grounds), red/purple spots on the||
2335|096|S|skin.||
2335|097|S|   A very serious allergic reaction to this drug is rare.||
2335|098|S|However, get medical help right away if you notice any symptoms||
2335|099|S|of a serious allergic reaction, including: rash, itching/swelling||
2335|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2335|101|S|breathing.||
2335|102|S|   This is not a complete list of possible side effects. If you||
2335|103|S|notice other effects not listed above, contact your doctor or||
2335|104|S|pharmacist.||
2335|105|S|   In the US -||
2335|106|S|   Call your doctor for medical advice about side effects. You||
2335|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2335|108|S|www.fda.gov/medwatch.||
2335|109|S|   In Canada - Call your doctor for medical advice about side||
2335|110|S|effects. You may report side effects to Health Canada at||
2335|111|S|1-866-234-2345.||
2335|112|B|||
2335|113|P|PRECAUTIONS:  Before taking budesonide, tell your doctor if you||
2335|114|P|are allergic to it; or if you have any other allergies. This||
2335|115|P|product may contain inactive ingredients, which can cause||
2335|116|P|allergic reactions or other problems. Talk to your pharmacist for||
2335|117|P|more details.||
2335|118|P|   Before using this medication, tell your doctor or pharmacist||
2335|119|P|your medical history, especially of: eye problems (such as||
2335|120|P|cataracts, glaucoma), high blood pressure, liver problems (such||
2335|121|P|as hepatitis B), diabetes, stomach/intestinal problems (such as||
2335|122|P|diverticulitis, ulcer), bone loss (osteoporosis), current/past||
2335|123|P|infections (such as tuberculosis, herpes), bleeding problems,||
2335|124|P|mental/mood problems (such as psychosis, anxiety, depression), a||
2335|125|P|certain adrenal gland tumor (pheochromocytoma).||
2335|126|P|   Using corticosteroid medications for a long time can make it||
2335|127|P|more difficult for your body to respond to physical stress.||
2335|128|P|Before having surgery or emergency treatment, or if you get a||
2335|129|P|serious illness/injury, tell your doctor or dentist that you are||
2335|130|P|using this medication or have used this medication within the||
2335|131|P|past 12 months. Tell your doctor right away if you develop||
2335|132|P|unusual/extreme tiredness or weight loss. If you will be using||
2335|133|P|this medication for a long time, carry a warning card or medical||
2335|134|P|ID bracelet that identifies your use of this medication.||
2335|135|P|   Before having surgery, tell your doctor or dentist about all||
2335|136|P|the products you use (including prescription drugs,||
2335|137|P|nonprescription drugs, and herbal products).||
2335|138|P|   Daily use of alcohol while using this medicine may increase||
2335|139|P|your risk for stomach bleeding. Limit alcoholic beverages.||
2335|140|P|Consult your doctor or pharmacist for more information.||
2335|141|P|   This medication can make you more likely to get infections or||
2335|142|P|may make current infections worse. Stay away from anyone who has||
2335|143|P|an infection that may easily spread (such as chickenpox,||
2335|144|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2335|145|P|exposed to an infection or for more details.||
2335|146|P|   Tell your health care professional that you are using||
2335|147|P|budesonide before having any immunizations/vaccinations. Avoid||
2335|148|P|contact with people who have recently received live vaccines||
2335|149|P|(such as flu vaccine inhaled through the nose).||
2335|150|P|   Older adults may be more sensitive to the side effects of this||
2335|151|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
2335|152|P|mental/mood changes (such as confusion).||
2335|153|P|   This medication may slow down a child's growth if used for a||
2335|154|P|long time. Consult the doctor or pharmacist for more details. See||
2335|155|P|the doctor regularly so your child's height and growth can be||
2335|156|P|checked.||
2335|157|P|   During pregnancy, this medication should be used only when||
2335|158|P|clearly needed. Discuss the risks and benefits with your doctor.||
2335|159|P|Babies born to mothers who have used corticosteroids for a long||
2335|160|P|time may develop hormone problems. Tell your doctor right away if||
2335|161|P|you notice symptoms such as nausea/vomiting that doesn't stop,||
2335|162|P|severe diarrhea, or weakness in your newborn.||
2335|163|P|   This medication passes into breast milk. Consult your doctor||
2335|164|P|before breastfeeding.||
2335|165|B|||
2335|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2335|167|I|medications work or increase your risk for serious side effects.||
2335|168|I|This document does not contain all possible drug interactions.||
2335|169|I|Keep a list of all the products you use (including||
2335|170|I|prescription/nonprescription drugs and herbal products) and share||
2335|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
2335|172|I|the dosage of any medicines without your doctor's approval.||
2335|173|I|   Some products that may interact with this drug are:||
2335|174|I|aldesleukin, desmopressin, mifepristone, drugs that can cause||
2335|175|I|bleeding/bruising (including antiplatelet drugs such as||
2335|176|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
2335|177|I|such as warfarin/dabigatran).||
2335|178|I|   If your doctor has told you to take low-dose aspirin to||
2335|179|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
2335|180|I|you should keep taking the aspirin unless your doctor tells you||
2335|181|I|not to. Ask your doctor or pharmacist for more details.||
2335|182|I|   This product may interfere with certain lab tests (such as||
2335|183|I|skin tests), possibly causing false test results. Make sure lab||
2335|184|I|personnel and all your doctors know you use this drug.||
2335|185|B|||
2335|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2335|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2335|188|O|poison control center right away. US residents can call||
2335|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2335|190|B|||
2335|191|N|NOTES:  Do not share this medication with others.||
2335|192|N|   If this medication is used for a long time, lab and/or medical||
2335|193|N|tests (such as blood count, bone density, eye exams,||
2335|194|N|height/weight measurements) may be done while you are taking it.||
2335|195|N|Keep all medical and lab appointments. Consult your doctor for||
2335|196|N|more details.||
2335|197|N|   This medication may cause bone loss (osteoporosis) when used||
2335|198|N|for a long time. Lifestyle changes that may help reduce the risk||
2335|199|N|of bone problems include doing weight-bearing exercise, stopping||
2335|200|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2335|201|N|D. Talk to your doctor for more details.||
2335|202|B|||
2335|203|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2335|204|D|remember. If it is near the time of the next dose, skip the||
2335|205|D|missed dose. Take your next dose at the regular time. Do not||
2335|206|D|double the dose to catch up.||
2335|207|B|||
2335|208|R|STORAGE:  Store in the original package at room temperature away||
2335|209|R|from light and moisture. Do not store in the bathroom. Keep all||
2335|210|R|medications away from children and pets.||
2335|211|R|   Do not flush medications down the toilet or pour them into a||
2335|212|R|drain unless instructed to do so. Properly discard this product||
2335|213|R|when it is expired or no longer needed. Consult your pharmacist||
2335|214|R|or local waste disposal company.||
2335|215|B|||
2335|216|M|MEDICAL ALERT:  Your condition can cause complications in a||
2335|217|M|medical emergency. For information about enrolling in MedicAlert,||
2335|218|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2335|219|B|||
2335|220|A|Information last revised September 2025.||
2335|221|A|Copyright(c) 2025 First Databank, Inc.||
2335|222|B|||
2336|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2336|002|Z|does NOT have all possible information about this product. This||
2336|003|Z|information does not assure that this product is safe, effective,||
2336|004|Z|or appropriate for you. This information is not individual||
2336|005|Z|medical advice and does not substitute for the advice of your||
2336|006|Z|health care professional. Always ask your health care||
2336|007|Z|professional for complete information about this product and your||
2336|008|Z|specific health needs.||
2336|009|B|||
2336|010|T|VERICIGUAT - ORAL||
2336|011|F|(VER-i-SIG-ue-at)||
2336|012|B|||
2336|013|C|COMMON BRAND NAME(S): Verquvo||
2336|014|B|||
2336|015|W|WARNING:  Vericiguat must not be used during pregnancy. It may||
2336|016|W|harm an unborn baby. It is important to prevent pregnancy while||
2336|017|W|taking this medication and for 1 month after treatment. Female||
2336|018|W|patients must use reliable birth control during treatment and for||
2336|019|W|1 month after the end of treatment. Ask your doctor which forms||
2336|020|W|of birth control to use while taking this medication. Female||
2336|021|W|patients must take a pregnancy test before starting treatment. If||
2336|022|W|you become pregnant or think you may be pregnant, tell your||
2336|023|W|doctor right away.||
2336|024|B|||
2336|025|U|USES:  Vericiguat is used to treat certain types of heart||
2336|026|U|failure. It may help you live longer and lower your chance of||
2336|027|U|having to go to the hospital for heart failure. Vericiguat works||
2336|028|U|by relaxing and widening the blood vessels so blood can flow more||
2336|029|U|easily, which makes it easier for your heart to pump blood to||
2336|030|U|your body.||
2336|031|B|||
2336|032|H|HOW TO USE:  Read the Medication Guide provided by your||
2336|033|H|pharmacist before you start taking vericiguat and each time you||
2336|034|H|get a refill. If you have any questions, ask your doctor or||
2336|035|H|pharmacist.||
2336|036|H|   Take this medication by mouth with food as directed by your||
2336|037|H|doctor, usually once daily.||
2336|038|H|   If you have trouble swallowing the tablets, a dose may be||
2336|039|H|crushed and mixed with water. Take the entire mixture right away.||
2336|040|H|Do not save for future use.||
2336|041|H|   To reduce your risk of side effects (such as low blood||
2336|042|H|pressure), your doctor may direct you to start this medication at||
2336|043|H|a low dose and gradually increase your dose. Follow your doctor's||
2336|044|H|instructions carefully.||
2336|045|H|   Use this medication regularly to get the most benefit from it.||
2336|046|H|To help you remember, take it at the same time each day.||
2336|047|H|   Do not increase your dose or use this drug more often than||
2336|048|H|prescribed. Your condition will not improve any faster, and your||
2336|049|H|risk of side effects will increase.||
2336|050|H|   Tell your doctor if your condition does not get better or if||
2336|051|H|it gets worse.||
2336|052|B|||
2336|053|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur. If either||
2336|054|S|of these effects lasts or gets worse, tell your doctor or||
2336|055|S|pharmacist promptly.||
2336|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
2336|057|S|slowly when rising from a sitting or lying position.||
2336|058|S|   Remember that this medication has been prescribed because your||
2336|059|S|doctor has judged that the benefit to you is greater than the||
2336|060|S|risk of side effects. Many people using this medication do not||
2336|061|S|have serious side effects.||
2336|062|S|   Tell your doctor right away if you have any serious side||
2336|063|S|effects, including: signs of anemia (such as unusual tiredness,||
2336|064|S|pale skin, fast heartbeat).||
2336|065|S|   A very serious allergic reaction to this drug is rare.||
2336|066|S|However, get medical help right away if you notice any symptoms||
2336|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2336|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2336|069|S|breathing.||
2336|070|S|   This is not a complete list of possible side effects. If you||
2336|071|S|notice other effects not listed above, contact your doctor or||
2336|072|S|pharmacist.||
2336|073|S|   In the US -||
2336|074|S|   Call your doctor for medical advice about side effects. You||
2336|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2336|076|S|www.fda.gov/medwatch.||
2336|077|S|   In Canada - Call your doctor for medical advice about side||
2336|078|S|effects. You may report side effects to Health Canada at||
2336|079|S|1-866-234-2345.||
2336|080|B|||
2336|081|P|PRECAUTIONS:  Before taking vericiguat, tell your doctor or||
2336|082|P|pharmacist if you are allergic to it; or if you have any other||
2336|083|P|allergies. This product may contain inactive ingredients, which||
2336|084|P|can cause allergic reactions or other problems. Talk to your||
2336|085|P|pharmacist for more details.||
2336|086|P|   Before using this medication, tell your doctor or pharmacist||
2336|087|P|your medical history.||
2336|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2336|089|P|can make you more dizzy. Do not drive, use machinery, or do||
2336|090|P|anything that needs alertness until you can do it safely. Limit||
2336|091|P|alcoholic beverages. Talk to your doctor if you are using||
2336|092|P|marijuana (cannabis).||
2336|093|P|   Before having surgery, tell your doctor or dentist about all||
2336|094|P|the products you use (including prescription drugs,||
2336|095|P|nonprescription drugs, and herbal products).||
2336|096|P|   This medication must not be used during pregnancy. It may harm||
2336|097|P|an unborn baby. See also Warning section.||
2336|098|P|   It is unknown if this medication passes into breast milk.||
2336|099|P|Because of the possible risk to the infant, breastfeeding is not||
2336|100|P|recommended while using this medication. Consult your doctor||
2336|101|P|before breastfeeding.||
2336|102|B|||
2336|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2336|104|I|medications work or increase your risk for serious side effects.||
2336|105|I|This document does not contain all possible drug interactions.||
2336|106|I|Keep a list of all the products you use (including||
2336|107|I|prescription/nonprescription drugs and herbal products) and share||
2336|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
2336|109|I|the dosage of any medicines without your doctor's approval.||
2336|110|I|   Some products that may interact with this drug are:||
2336|111|I|aminophylline, dipyridamole, drugs to treat erectile||
2336|112|I|dysfunction-ED/pulmonary hypertension (such as sildenafil,||
2336|113|I|tadalafil, vardenafil), riociguat, theophylline.||
2336|114|B|||
2336|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2336|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2336|117|O|poison control center right away. US residents can call||
2336|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2336|119|B|||
2336|120|N|NOTES:  Do not share this medication with others.||
2336|121|N|   Medical tests (such as blood pressure) may be done while you||
2336|122|N|are taking this medication. Keep all medical and lab||
2336|123|N|appointments. Consult your doctor for more details.||
2336|124|B|||
2336|125|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2336|126|D|remember. If it is near the time of the next dose, skip the||
2336|127|D|missed dose. Take your next dose at the regular time. Do not||
2336|128|D|double the dose to catch up.||
2336|129|B|||
2336|130|R|STORAGE:  Store at room temperature away from light and moisture.||
2336|131|R|Do not store in the bathroom. Keep all medications away from||
2336|132|R|children and pets.||
2336|133|R|   Do not flush medications down the toilet or pour them into a||
2336|134|R|drain unless instructed to do so. Properly discard this product||
2336|135|R|when it is expired or no longer needed. Consult your pharmacist||
2336|136|R|or local waste disposal company.||
2336|137|B|||
2336|138|A|Information last revised May 2024.||
2336|139|A|Copyright(c) 2025 First Databank, Inc.||
2336|140|B|||
2337|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2337|002|Z|does NOT have all possible information about this product. This||
2337|003|Z|information does not assure that this product is safe, effective,||
2337|004|Z|or appropriate for you. This information is not individual||
2337|005|Z|medical advice and does not substitute for the advice of your||
2337|006|Z|health care professional. Always ask your health care||
2337|007|Z|professional for complete information about this product and your||
2337|008|Z|specific health needs.||
2337|009|B|||
2337|010|T|VOCLOSPORIN - ORAL||
2337|011|F|(VOE-kloe-SPOR-in)||
2337|012|B|||
2337|013|C|COMMON BRAND NAME(S): Lupkynis||
2337|014|B|||
2337|015|W|WARNING:  Voclosporin lowers your ability to fight infections.||
2337|016|W|This may make you more likely to get a serious (rarely fatal)||
2337|017|W|infection or make any infection you have worse. This effect may||
2337|018|W|also increase your risk of getting certain types of cancer (such||
2337|019|W|as skin cancer, lymphoma). Tell your doctor right away if you||
2337|020|W|have any signs of infection or cancer such as sore throat that||
2337|021|W|doesn't go away, fever, chills, burning/frequent urination,||
2337|022|W|unusual skin changes, change in appearance or size of moles,||
2337|023|W|unusual weight loss, swollen lymph nodes, unusual lumps, night||
2337|024|W|sweats.||
2337|025|B|||
2337|026|U|USES:  Voclosporin is used in combination with other medications||
2337|027|U|to treat a certain kidney disorder (lupus nephritis). Lupus||
2337|028|U|nephritis is an immune disorder where certain proteins in your||
2337|029|U|own body attack and cause damage to the kidneys. Symptoms may||
2337|030|U|include blood/protein in the urine, high blood pressure, and poor||
2337|031|U|kidney function. Voclosporin belongs to a class of drugs known as||
2337|032|U|immunosuppressants. It works by weakening the immune system to||
2337|033|U|help decrease damage to your kidneys.||
2337|034|B|||
2337|035|H|HOW TO USE:  Read the Medication Guide provided by your||
2337|036|H|pharmacist before you start taking voclosporin and each time you||
2337|037|H|get a refill. If you have any questions, ask your doctor or||
2337|038|H|pharmacist.||
2337|039|H|   Take this medication by mouth on an empty stomach (1 hour||
2337|040|H|before or 2 hours after a meal) as directed by your doctor,||
2337|041|H|usually twice daily. Take your doses of this medication as close||
2337|042|H|to 12 hours apart as you can. Do not take your doses less than 8||
2337|043|H|hours apart. Swallow this medication whole. Do not open, crush,||
2337|044|H|chew, or dissolve the capsules. Doing so may increase the risk of||
2337|045|H|side effects.||
2337|046|H|   The dosage is based on your medical condition and response to||
2337|047|H|treatment.||
2337|048|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2337|049|H|using this medication unless your doctor or pharmacist says you||
2337|050|H|may do so safely. Grapefruit can increase the chance of side||
2337|051|H|effects with this medicine. Ask your doctor or pharmacist for||
2337|052|H|more details.||
2337|053|H|   Use this medication regularly to get the most benefit from it.||
2337|054|H|To help you remember, take it at the same times each day.||
2337|055|B|||
2337|056|S|SIDE EFFECTS:  See also Warning section.||
2337|057|S|   Headache, tiredness, dizziness, diarrhea, shaking, upset||
2337|058|S|stomach, or abdominal pain may occur. If any of these effects||
2337|059|S|last or get worse, tell your doctor or pharmacist promptly.||
2337|060|S|   Temporary hair loss may occur. Normal hair growth should||
2337|061|S|return after treatment has ended.||
2337|062|S|   People using this medication may have serious side effects.||
2337|063|S|However, you have been prescribed this drug because your doctor||
2337|064|S|has judged that the benefit to you is greater than the risk of||
2337|065|S|side effects. Careful monitoring by your doctor may decrease your||
2337|066|S|risk.||
2337|067|S|   This medication may raise your blood pressure. Check your||
2337|068|S|blood pressure regularly and tell your doctor if the results are||
2337|069|S|high. Your doctor may control your blood pressure with||
2337|070|S|medication.||
2337|071|S|   Tell your doctor right away if you have any serious side||
2337|072|S|effects, including: signs of kidney problems (such as a change in||
2337|073|S|the amount of urine), mental/mood changes (such as confusion,||
2337|074|S|changes in alertness), easy bruising/bleeding, numbness/tingling,||
2337|075|S|vision changes.||
2337|076|S|   Get medical help right away if you have any very serious side||
2337|077|S|effects, including: seizures.||
2337|078|S|   A very serious allergic reaction to this drug is rare.||
2337|079|S|However, get medical help right away if you notice any symptoms||
2337|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2337|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2337|082|S|breathing.||
2337|083|S|   This is not a complete list of possible side effects. If you||
2337|084|S|notice other effects not listed above, contact your doctor or||
2337|085|S|pharmacist.||
2337|086|S|   In the US -||
2337|087|S|   Call your doctor for medical advice about side effects. You||
2337|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2337|089|S|www.fda.gov/medwatch.||
2337|090|S|   In Canada - Call your doctor for medical advice about side||
2337|091|S|effects. You may report side effects to Health Canada at||
2337|092|S|1-866-234-2345.||
2337|093|B|||
2337|094|P|PRECAUTIONS:  Before taking voclosporin, tell your doctor or||
2337|095|P|pharmacist if you are allergic to it; or if you have any other||
2337|096|P|allergies. This product may contain inactive ingredients, which||
2337|097|P|can cause allergic reactions or other problems. Talk to your||
2337|098|P|pharmacist for more details.||
2337|099|P|   Before using this medication, tell your doctor or pharmacist||
2337|100|P|your medical history, especially of: kidney problems, liver||
2337|101|P|problems, high blood pressure, recent/current infections.||
2337|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2337|103|P|can make you more dizzy. Do not drive, use machinery, or do||
2337|104|P|anything that needs alertness until you can do it safely. Limit||
2337|105|P|alcoholic beverages. Talk to your doctor if you are using||
2337|106|P|marijuana (cannabis).||
2337|107|P|   Voclosporin can make you more likely to get infections or may||
2337|108|P|make current infections worse. Stay away from anyone who has an||
2337|109|P|infection that may easily spread (such as chickenpox, COVID-19,||
2337|110|P|measles, flu). Talk to your doctor if you have been exposed to an||
2337|111|P|infection or for more details.||
2337|112|P|   Tell your health care professional that you are using||
2337|113|P|voclosporin before having any immunizations/vaccinations. Avoid||
2337|114|P|contact with people who have recently received live vaccines||
2337|115|P|(such as flu vaccine inhaled through the nose).||
2337|116|P|   This medication may increase your risk of developing skin||
2337|117|P|cancer. Limit your time in the sun. Avoid tanning booths and||
2337|118|P|sunlamps. Use sunscreen and wear protective clothing when||
2337|119|P|outdoors. Tell your doctor right away if you get sunburned, have||
2337|120|P|skin blisters/redness, or notice new or changed moles/skin||
2337|121|P|lesions.||
2337|122|P|   Before having surgery, tell your doctor or dentist about all||
2337|123|P|the products you use (including prescription drugs,||
2337|124|P|nonprescription drugs, and herbal products).||
2337|125|P|   Tell your doctor if you are pregnant or plan to become||
2337|126|P|pregnant. You should not become pregnant while using voclosporin.||
2337|127|P|Voclosporin contains alcohol and may harm an unborn baby. If you||
2337|128|P|become pregnant, talk to your doctor right away about the risks||
2337|129|P|and benefits of this medication.||
2337|130|P|   This medication passes into breast milk. Consult your doctor||
2337|131|P|before breastfeeding.||
2337|132|B|||
2337|133|I|DRUG INTERACTIONS:  See also How to Use section.||
2337|134|I|   Drug interactions may change how your medications work or||
2337|135|I|increase your risk for serious side effects. This document does||
2337|136|I|not contain all possible drug interactions. Keep a list of all||
2337|137|I|the products you use (including prescription/nonprescription||
2337|138|I|drugs and herbal products) and share it with your doctor and||
2337|139|I|pharmacist. Do not start, stop, or change the dosage of any||
2337|140|I|medicines without your doctor's approval.||
2337|141|I|   Some products that may interact with this drug are:||
2337|142|I|cyclophosphamide, drugs that may increase potassium levels (such||
2337|143|I|as potassium supplements, certain diuretics/"water pills"||
2337|144|I|including amiloride, spironolactone).||
2337|145|I|   Other medications can affect the removal of voclosporin from||
2337|146|I|your body, which may affect how voclosporin works. Examples||
2337|147|I|include azole antifungals (such as itraconazole, ketoconazole),||
2337|148|I|HIV protease inhibitors (such as lopinavir, ritonavir), macrolide||
2337|149|I|antibiotics (such as clarithromycin, erythromycin), rifamycins||
2337|150|I|(such as rifabutin, rifampin), St. John's wort, drugs used to||
2337|151|I|treat seizures (such as carbamazepine, phenytoin), among others.||
2337|152|I|   This medication can slow down the removal of other medications||
2337|153|I|from your body, which may affect how they work. Examples of||
2337|154|I|affected drugs include elagolix, elbasvir/grazoprevir, among||
2337|155|I|others.||
2337|156|B|||
2337|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2337|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2337|159|O|poison control center right away. US residents can call||
2337|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2337|161|B|||
2337|162|N|NOTES:  Do not share this medication with others.||
2337|163|N|   Lab and/or medical tests (such as kidney function, blood||
2337|164|N|pressure, blood mineral levels, complete blood count, skin exam)||
2337|165|N|should be done while you are taking this medication. Keep all||
2337|166|N|medical and lab appointments. Consult your doctor for more||
2337|167|N|details.||
2337|168|B|||
2337|169|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2337|170|D|remember. If it is more than 4 hours after the missed dose, skip||
2337|171|D|the missed dose. Take your next dose at the regular time. Do not||
2337|172|D|double the dose to catch up.||
2337|173|B|||
2337|174|R|STORAGE:  Store in the original package at room temperature away||
2337|175|R|from heat and moisture. Do not store in the bathroom. Keep all||
2337|176|R|medications away from children and pets.||
2337|177|R|   Do not flush medications down the toilet or pour them into a||
2337|178|R|drain unless instructed to do so. Properly discard this product||
2337|179|R|when it is expired or no longer needed. Consult your pharmacist||
2337|180|R|or local waste disposal company.||
2337|181|B|||
2337|182|M|MEDICAL ALERT:  Your condition can cause complications in a||
2337|183|M|medical emergency. For information about enrolling in MedicAlert,||
2337|184|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2337|185|B|||
2337|186|A|Information last revised April 2025.||
2337|187|A|Copyright(c) 2025 First Databank, Inc.||
2337|188|B|||
2338|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2338|002|Z|does NOT have all possible information about this product. This||
2338|003|Z|information does not assure that this product is safe, effective,||
2338|004|Z|or appropriate for you. This information is not individual||
2338|005|Z|medical advice and does not substitute for the advice of your||
2338|006|Z|health care professional. Always ask your health care||
2338|007|Z|professional for complete information about this product and your||
2338|008|Z|specific health needs.||
2338|009|B|||
2338|010|T|IBREXAFUNGERP - ORAL||
2338|011|F|(eye-BREX-a-FUNJ-erp)||
2338|012|B|||
2338|013|C|COMMON BRAND NAME(S): Brexafemme||
2338|014|B|||
2338|015|W|WARNING:  This medication must not be used during pregnancy. It||
2338|016|W|may harm an unborn baby. Your doctor should order a pregnancy||
2338|017|W|test before starting this medication. Ask about reliable forms of||
2338|018|W|birth control while using this medication and for 4 days after||
2338|019|W|the last dose. If you are using this medication monthly, a||
2338|020|W|pregnancy test should also be ordered before taking your monthly||
2338|021|W|dose and birth control should be used during the 6-month||
2338|022|W|treatment period and for 4 days after the last dose. If you||
2338|023|W|become pregnant or think you may be pregnant, tell your doctor||
2338|024|W|right away.||
2338|025|B|||
2338|026|U|USES:  This medication is used to treat or prevent vaginal yeast||
2338|027|U|infections. Some yeast normally live inside the body and on skin||
2338|028|U|without causing any problems. However, sometimes the yeast can||
2338|029|U|multiply and cause an infection under certain conditions (such as||
2338|030|U|being pregnant, having diabetes, or taking antibiotics or||
2338|031|U|hormonal birth control). This medication belongs to a class of||
2338|032|U|medications known as antifungal drugs. It works by stopping the||
2338|033|U|growth of fungi (such as yeast). Treatment with this medication||
2338|034|U|can decrease symptoms of vaginal yeast infection such as abnormal||
2338|035|U|vaginal discharge or itching/soreness, pain during sexual||
2338|036|U|intercourse, or pain when urinating.||
2338|037|B|||
2338|038|H|HOW TO USE:  Read the Medication Guide provided by your||
2338|039|H|pharmacist before you start taking ibrexafungerp and each time||
2338|040|H|you get a refill. If you have any questions, ask your doctor or||
2338|041|H|pharmacist.||
2338|042|H|   Take this medication by mouth with or without food as directed||
2338|043|H|by your doctor, usually for 2 doses (about 12 hours apart). If||
2338|044|H|used for preventing vaginal yeast infections, this medication is||
2338|045|H|usually taken this way every month for 6 months. The dosage is||
2338|046|H|based on other medications you may be taking. Be sure to tell||
2338|047|H|your doctor and pharmacist about all the products you use||
2338|048|H|(including prescription drugs, nonprescription drugs, and herbal||
2338|049|H|products).||
2338|050|H|   Tell your doctor if your condition lasts or gets worse.||
2338|051|B|||
2338|052|S|SIDE EFFECTS:  Nausea, stomach/abdominal pain, vomiting,||
2338|053|S|dizziness, headache, or diarrhea may occur. If any of these||
2338|054|S|effects last or get worse, tell your doctor or pharmacist||
2338|055|S|promptly.||
2338|056|S|   Remember that this medication has been prescribed because your||
2338|057|S|doctor has judged that the benefit to you is greater than the||
2338|058|S|risk of side effects. Many people using this medication do not||
2338|059|S|have serious side effects.||
2338|060|S|   A very serious allergic reaction to this drug is rare.||
2338|061|S|However, get medical help right away if you notice any symptoms||
2338|062|S|of a serious allergic reaction, including: rash, itching/swelling||
2338|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2338|064|S|breathing.||
2338|065|S|   This is not a complete list of possible side effects. If you||
2338|066|S|notice other effects not listed above, contact your doctor or||
2338|067|S|pharmacist.||
2338|068|S|   In the US -||
2338|069|S|   Call your doctor for medical advice about side effects. You||
2338|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2338|071|S|www.fda.gov/medwatch.||
2338|072|S|   In Canada - Call your doctor for medical advice about side||
2338|073|S|effects. You may report side effects to Health Canada at||
2338|074|S|1-866-234-2345.||
2338|075|B|||
2338|076|P|PRECAUTIONS:  See also Warning section.||
2338|077|P|   Before taking ibrexafungerp, tell your doctor or pharmacist if||
2338|078|P|you are allergic to it; or if you have any other allergies. This||
2338|079|P|product may contain inactive ingredients, which can cause||
2338|080|P|allergic reactions or other problems. Talk to your pharmacist for||
2338|081|P|more details.||
2338|082|P|   Before using this medication, tell your doctor or pharmacist||
2338|083|P|your medical history.||
2338|084|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2338|085|P|can make you more dizzy. Do not drive, use machinery, or do||
2338|086|P|anything that needs alertness until you can do it safely. Limit||
2338|087|P|alcoholic beverages. Talk to your doctor if you are using||
2338|088|P|marijuana (cannabis).||
2338|089|P|   Before having surgery, tell your doctor or dentist about all||
2338|090|P|the products you use (including prescription drugs,||
2338|091|P|nonprescription drugs, and herbal products).||
2338|092|P|   This medication must not be used during pregnancy. It may harm||
2338|093|P|an unborn baby. If you become pregnant or think you may be||
2338|094|P|pregnant, tell your doctor right away.||
2338|095|P|   This medication passes into breast milk. Consult your doctor||
2338|096|P|before breastfeeding.||
2338|097|B|||
2338|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2338|099|I|medications work or increase your risk for serious side effects.||
2338|100|I|This document does not contain all possible drug interactions.||
2338|101|I|Keep a list of all the products you use (including||
2338|102|I|prescription/nonprescription drugs and herbal products) and share||
2338|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
2338|104|I|the dosage of any medicines without your doctor's approval.||
2338|105|I|   Other medications can affect the removal of ibrexafungerp from||
2338|106|I|your body, which may affect how ibrexafungerp works. Examples||
2338|107|I|include azole antifungals (such as itraconazole, ketoconazole),||
2338|108|I|macrolide antibiotics (such as clarithromycin), rifamycins (such||
2338|109|I|as rifabutin, rifampin), St. John's wort, drugs used to treat||
2338|110|I|seizures (such as carbamazepine, phenobarbital, phenytoin), among||
2338|111|I|others.||
2338|112|B|||
2338|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2338|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2338|115|O|poison control center right away. US residents can call||
2338|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2338|117|B|||
2338|118|N|NOTES:  Do not share this medication with others.||
2338|119|B|||
2338|120|D|MISSED DOSE:  It is important to take this medication exactly as||
2338|121|D|prescribed. If you miss the second dose, take it as soon as you||
2338|122|D|remember. If you miss your monthly dose, ask your doctor or||
2338|123|D|pharmacist right away for a new dosing schedule.||
2338|124|B|||
2338|125|R|STORAGE:  Store at room temperature away from light and moisture.||
2338|126|R|Do not store in the bathroom. Keep all medications away from||
2338|127|R|children and pets.||
2338|128|R|   Do not flush medications down the toilet or pour them into a||
2338|129|R|drain unless instructed to do so. Properly discard this product||
2338|130|R|when it is expired or no longer needed. Consult your pharmacist||
2338|131|R|or local waste disposal company.||
2338|132|B|||
2338|133|A|Information last revised November 2025.||
2338|134|A|Copyright(c) 2025 First Databank, Inc.||
2338|135|B|||
2339|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2339|002|Z|does NOT have all possible information about this product. This||
2339|003|Z|information does not assure that this product is safe, effective,||
2339|004|Z|or appropriate for you. This information is not individual||
2339|005|Z|medical advice and does not substitute for the advice of your||
2339|006|Z|health care professional. Always ask your health care||
2339|007|Z|professional for complete information about this product and your||
2339|008|Z|specific health needs.||
2339|009|B|||
2339|010|T|FINERENONE - ORAL||
2339|011|F|(fin-ER-e-none)||
2339|012|B|||
2339|013|C|COMMON BRAND NAME(S): Kerendia||
2339|014|B|||
2339|015|U|USES:  Finerenone is used by people with type 2 diabetes and||
2339|016|U|kidney disease to lower the risk of dialysis, death from heart||
2339|017|U|disease, heart attacks, and the need to go to the hospital for||
2339|018|U|heart failure.||
2339|019|U|   It is also used by people with heart failure to lower the risk||
2339|020|U|of death from heart disease and the need to go to a doctor or||
2339|021|U|hospital to treat heart failure.||
2339|022|U|   It works by blocking a chemical (aldosterone) in your body||
2339|023|U|which in turn lowers the amount of sodium and water the body||
2339|024|U|retains.||
2339|025|B|||
2339|026|H|HOW TO USE:  Take this medication by mouth with or without food||
2339|027|H|as directed by your doctor, usually once daily.||
2339|028|H|   To reduce your risk of side effects, your doctor may direct||
2339|029|H|you to start this medication at a low dose and gradually increase||
2339|030|H|your dose. Follow your doctor's instructions carefully.||
2339|031|H|   If you are unable to swallow whole tablets, you may crush the||
2339|032|H|tablet and mix it with water or soft foods (such as applesauce).||
2339|033|H|Drink/eat the entire mixture right away. Do not prepare a supply||
2339|034|H|for future use.||
2339|035|H|   The dosage is based on your medical condition and response to||
2339|036|H|treatment.||
2339|037|H|   Use this medication regularly to get the most benefit from it.||
2339|038|H|To help you remember, take it at the same time each day.||
2339|039|H|   Do not increase your dose or use this drug more often or for||
2339|040|H|longer than prescribed. Your condition will not improve any||
2339|041|H|faster, and your risk of side effects will increase.||
2339|042|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2339|043|H|using this medication unless your doctor or pharmacist says you||
2339|044|H|may do so safely. Grapefruit can increase the chance of side||
2339|045|H|effects with this medicine. Ask your doctor or pharmacist for||
2339|046|H|more details.||
2339|047|B|||
2339|048|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur. If either||
2339|049|S|of these effects lasts or gets worse, tell your doctor or||
2339|050|S|pharmacist promptly.||
2339|051|S|   Remember that this medication has been prescribed because your||
2339|052|S|doctor has judged that the benefit to you is greater than the||
2339|053|S|risk of side effects. Many people using this medication do not||
2339|054|S|have serious side effects.||
2339|055|S|   Tell your doctor right away if you have any serious side||
2339|056|S|effects, including: symptoms of a high potassium blood level||
2339|057|S|(such as muscle weakness, slow/irregular heartbeat), symptoms of||
2339|058|S|a low sodium blood level (such as nausea, extreme drowsiness,||
2339|059|S|mental/mood changes, seizures).||
2339|060|S|   A very serious allergic reaction to this drug is rare.||
2339|061|S|However, get medical help right away if you notice any symptoms||
2339|062|S|of a serious allergic reaction, including: rash, itching/swelling||
2339|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2339|064|S|breathing.||
2339|065|S|   This is not a complete list of possible side effects. If you||
2339|066|S|notice other effects not listed above, contact your doctor or||
2339|067|S|pharmacist.||
2339|068|S|   In the US -||
2339|069|S|   Call your doctor for medical advice about side effects. You||
2339|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2339|071|S|www.fda.gov/medwatch.||
2339|072|S|   In Canada - Call your doctor for medical advice about side||
2339|073|S|effects. You may report side effects to Health Canada at||
2339|074|S|1-866-234-2345.||
2339|075|B|||
2339|076|P|PRECAUTIONS:  Before taking finerenone, tell your doctor or||
2339|077|P|pharmacist if you are allergic to it; or if you have any other||
2339|078|P|allergies. This product may contain inactive ingredients, which||
2339|079|P|can cause allergic reactions or other problems. Talk to your||
2339|080|P|pharmacist for more details.||
2339|081|P|   Before using this medication, tell your doctor or pharmacist||
2339|082|P|your medical history, especially of: high potassium blood levels||
2339|083|P|(hyperkalemia), decreased adrenal gland function, liver disease.||
2339|084|P|   This medication may increase your potassium levels. Before||
2339|085|P|using potassium supplements or salt substitutes that contain||
2339|086|P|potassium, consult your doctor or pharmacist.||
2339|087|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2339|088|P|can make you more dizzy. Do not drive, use machinery, or do||
2339|089|P|anything that needs alertness until you can do it safely. Limit||
2339|090|P|alcoholic beverages. Talk to your doctor if you are using||
2339|091|P|marijuana (cannabis).||
2339|092|P|   Before having surgery, tell your doctor or dentist about all||
2339|093|P|the products you use (including prescription drugs,||
2339|094|P|nonprescription drugs, and herbal products).||
2339|095|P|   During pregnancy, this medication should be used only when||
2339|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
2339|097|P|   It is unknown if this medication passes into breast milk.||
2339|098|P|Because of the possible risk to the infant, breastfeeding is not||
2339|099|P|recommended while using this medication and for 1 day after the||
2339|100|P|last dose. Consult your doctor before breastfeeding.||
2339|101|B|||
2339|102|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
2339|103|I|   Drug interactions may change how your medications work or||
2339|104|I|increase your risk for serious side effects. This document does||
2339|105|I|not contain all possible drug interactions. Keep a list of all||
2339|106|I|the products you use (including prescription/nonprescription||
2339|107|I|drugs and herbal products) and share it with your doctor and||
2339|108|I|pharmacist. Do not start, stop, or change the dosage of any||
2339|109|I|medicines without your doctor's approval.||
2339|110|I|   Some of the products that may interact with this drug are:||
2339|111|I|drugs that may increase the level of potassium in the blood (such||
2339|112|I|as birth control pills containing drospirenone, potassium sparing||
2339|113|I|"water pills" such as amiloride/spironolactone/triamterene),||
2339|114|I|lithium.||
2339|115|I|   Other medications can affect the removal of finerenone from||
2339|116|I|your body, which may affect how finerenone works. Examples||
2339|117|I|include adagrasib, certain azole antifungals (such as||
2339|118|I|ketoconazole, voriconazole), ceritinib, clarithromycin,||
2339|119|I|cobicistat, nefazodone, certain HIV protease inhibitors (such as||
2339|120|I|nelfinavir, tipranavir), ritonavir, telithromycin, among others.||
2339|121|B|||
2339|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2339|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2339|124|O|poison control center right away. US residents can call||
2339|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2339|126|B|||
2339|127|N|NOTES:  Do not share this medication with others.||
2339|128|N|   Lab tests (such as potassium blood levels, kidney function)||
2339|129|N|should be done before you start taking this medication and while||
2339|130|N|you are taking it. Keep all medical and lab appointments. Consult||
2339|131|N|your doctor for more details.||
2339|132|B|||
2339|133|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2339|134|D|remember. If it is near the time of the next dose, skip the||
2339|135|D|missed dose. Take your next dose at the regular time. Do not||
2339|136|D|double the dose to catch up.||
2339|137|B|||
2339|138|R|STORAGE:  Store at room temperature away from light and moisture.||
2339|139|R|Do not store in the bathroom. Keep all medications away from||
2339|140|R|children and pets.||
2339|141|R|   Do not flush medications down the toilet or pour them into a||
2339|142|R|drain unless instructed to do so. Properly discard this product||
2339|143|R|when it is expired or no longer needed. Consult your pharmacist||
2339|144|R|or local waste disposal company.||
2339|145|B|||
2339|146|A|Information last revised July 2025.||
2339|147|A|Copyright(c) 2025 First Databank, Inc.||
2339|148|B|||
2340|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2340|002|Z|does NOT have all possible information about this product. This||
2340|003|Z|information does not assure that this product is safe, effective,||
2340|004|Z|or appropriate for you. This information is not individual||
2340|005|Z|medical advice and does not substitute for the advice of your||
2340|006|Z|health care professional. Always ask your health care||
2340|007|Z|professional for complete information about this product and your||
2340|008|Z|specific health needs.||
2340|009|B|||
2340|010|T|LONAFARNIB - ORAL||
2340|011|F|(LOE-na-FAR-nib)||
2340|012|B|||
2340|013|C|COMMON BRAND NAME(S): Zokinvy||
2340|014|B|||
2340|015|U|USES:  This medication is used to lower the risk of death in||
2340|016|U|people with a certain rare condition (Hutchinson-Gilford Progeria||
2340|017|U|Syndrome - HGPS). It is also used to treat people with certain||
2340|018|U|other rare conditions (Progeroid Laminopathies). Lonafarnib works||
2340|019|U|by decreasing the amount of a harmful substance (progerin) caused||
2340|020|U|by these conditions.||
2340|021|B|||
2340|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
2340|023|H|Instructions for Use if available from your pharmacist before you||
2340|024|H|start using lonafarnib and each time you get a refill. If you||
2340|025|H|have any questions, ask your doctor or pharmacist.||
2340|026|H|   Take this medication by mouth as directed by your doctor,||
2340|027|H|usually twice a day: once with the morning meal and once with the||
2340|028|H|evening meal. Swallow the capsules whole with water. Do not crush||
2340|029|H|or chew.||
2340|030|H|   If you have trouble swallowing the capsule, it may be opened||
2340|031|H|and the contents mixed as directed in orange juice, applesauce,||
2340|032|H|or certain liquids used to make a suspension. Swallow the mixture||
2340|033|H|within 10 minutes of mixing it. Do not save the mixture for||
2340|034|H|future use.||
2340|035|H|   Avoid eating grapefruit or Seville oranges or drinking||
2340|036|H|grapefruit juice while using this medication unless your doctor||
2340|037|H|or pharmacist says you may do so safely. Do not mix the contents||
2340|038|H|of the capsule in juice containing grapefruit or Seville oranges.||
2340|039|H|Grapefruit and Seville oranges can increase the chance of side||
2340|040|H|effects with this medicine. Ask your doctor or pharmacist for||
2340|041|H|more details.||
2340|042|H|   The dosage is based on your medical condition, body size,||
2340|043|H|response to treatment, and other medications you may be taking.||
2340|044|H|Be sure to tell your doctor and pharmacist about all the products||
2340|045|H|you use (including prescription drugs, nonprescription drugs, and||
2340|046|H|herbal products).||
2340|047|H|   Use this medication regularly to get the most benefit from it.||
2340|048|H|To help you remember, take it at the same times each day.||
2340|049|H|   Do not increase your dose or use this drug more often than||
2340|050|H|prescribed. Your condition will not improve any faster, and your||
2340|051|H|risk of serious side effects will increase.||
2340|052|B|||
2340|053|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, abdominal pain, gas,||
2340|054|S|constipation, decreased appetite, tiredness, headache,||
2340|055|S|muscle/joint pain, or mouth sores may occur. If any of these||
2340|056|S|effects last or get worse, tell your doctor or pharmacist||
2340|057|S|promptly.||
2340|058|S|   Remember that this medication has been prescribed because your||
2340|059|S|doctor has judged that the benefit to you is greater than the||
2340|060|S|risk of side effects. Many people using this medication do not||
2340|061|S|have serious side effects.||
2340|062|S|   This medication may raise your blood pressure. Check your||
2340|063|S|blood pressure regularly and tell your doctor if the results are||
2340|064|S|high.||
2340|065|S|   Tell your doctor right away if you have any serious side||
2340|066|S|effects, including: unusual weight loss, signs of dehydration||
2340|067|S|(such as decreased urination, muscle cramps, dizziness), signs of||
2340|068|S|infection (such as sore throat that doesn't go away, fever,||
2340|069|S|chills), easy bruising/bleeding, unusual tiredness, mental/mood||
2340|070|S|changes (such as depression).||
2340|071|S|   Get medical help right away if you have any very serious side||
2340|072|S|effects, including: vision changes, confusion, trouble speaking,||
2340|073|S|fast/irregular heartbeat, severe dizziness, fainting.||
2340|074|S|   A very serious allergic reaction to this drug is rare.||
2340|075|S|However, get medical help right away if you notice any symptoms||
2340|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2340|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2340|078|S|breathing.||
2340|079|S|   This is not a complete list of possible side effects. If you||
2340|080|S|notice other effects not listed above, contact your doctor or||
2340|081|S|pharmacist.||
2340|082|S|   In the US -||
2340|083|S|   Call your doctor for medical advice about side effects. You||
2340|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2340|085|S|www.fda.gov/medwatch.||
2340|086|S|   In Canada - Call your doctor for medical advice about side||
2340|087|S|effects. You may report side effects to Health Canada at||
2340|088|S|1-866-234-2345.||
2340|089|B|||
2340|090|P|PRECAUTIONS:  Before using lonafarnib, tell your doctor or||
2340|091|P|pharmacist if you are allergic to it; or if you have any other||
2340|092|P|allergies. This product may contain inactive ingredients, which||
2340|093|P|can cause allergic reactions or other problems. Talk to your||
2340|094|P|pharmacist for more details.||
2340|095|P|   Before using this medication, tell your doctor or pharmacist||
2340|096|P|your medical history.||
2340|097|P|   Lonafarnib may cause a condition that affects the heart rhythm||
2340|098|P|(QT prolongation). QT prolongation can rarely cause serious||
2340|099|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2340|100|P|as severe dizziness, fainting) that need medical attention right||
2340|101|P|away.||
2340|102|P|   The risk of QT prolongation may be increased if you have||
2340|103|P|certain medical conditions or are taking other drugs that may||
2340|104|P|cause QT prolongation. Before using lonafarnib, tell your doctor||
2340|105|P|or pharmacist of all the drugs you take and if you have any of||
2340|106|P|the following conditions: certain heart problems (heart failure,||
2340|107|P|slow heartbeat, QT prolongation in the EKG), family history of||
2340|108|P|certain heart problems (QT prolongation in the EKG, sudden||
2340|109|P|cardiac death).||
2340|110|P|   Low levels of potassium or magnesium in the blood may also||
2340|111|P|increase your risk of QT prolongation. This risk may increase if||
2340|112|P|you use certain drugs (such as diuretics/"water pills") or if you||
2340|113|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2340|114|P|Talk to your doctor about using lonafarnib safely.||
2340|115|P|   Before having surgery, tell your doctor or dentist about all||
2340|116|P|the products you use (including prescription drugs,||
2340|117|P|nonprescription drugs, and herbal products).||
2340|118|P|   Older adults may be more sensitive to the side effects of this||
2340|119|P|drug, especially QT prolongation (see above).||
2340|120|P|   Tell your doctor if you are pregnant or plan to become||
2340|121|P|pregnant. You should not become pregnant while using lonafarnib.||
2340|122|P|Lonafarnib may harm an unborn baby. Ask about reliable forms of||
2340|123|P|birth control while using this medication. If you become||
2340|124|P|pregnant, talk to your doctor right away about the risks and||
2340|125|P|benefits of this medication.||
2340|126|P|   It is unknown if this drug passes into breast milk. Consult||
2340|127|P|your doctor before breastfeeding.||
2340|128|B|||
2340|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2340|130|I|medications work or increase your risk for serious side effects.||
2340|131|I|This document does not contain all possible drug interactions.||
2340|132|I|Keep a list of all the products you use (including||
2340|133|I|prescription/nonprescription drugs and herbal products) and share||
2340|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
2340|135|I|the dosage of any medicines without your doctor's approval.||
2340|136|I|   Other medications can affect the removal of lonafarnib from||
2340|137|I|your body, which may affect how lonafarnib works. Examples||
2340|138|I|include adagrasib, azole antifungals (such as ketoconazole),||
2340|139|I|belzutifan, butalbital, cenobamate, encorafenib, ivosidenib,||
2340|140|I|lefamulin, rifamycins (such as rifampin), ritonavir,||
2340|141|I|secobarbital, sotorasib, among others.||
2340|142|I|   This medication can slow down the removal of other medications||
2340|143|I|from your body, which may affect how they work. Examples of||
2340|144|I|affected drugs include ceritinib, daridorexant, elacestrant,||
2340|145|I|finerenone, mavacamten, midazolam, pacritinib, ribociclib,||
2340|146|I|sparsentan, certain "statin" cholesterol drugs (such as||
2340|147|I|atorvastatin, lovastatin, simvastatin), among others.||
2340|148|B|||
2340|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2340|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2340|151|O|poison control center right away. US residents can call||
2340|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2340|153|B|||
2340|154|N|NOTES:  Do not share this medication with others.||
2340|155|N|   Lab and/or medical tests (such as liver/kidney function,||
2340|156|N|complete blood count, hemoglobin/hematocrit, blood mineral||
2340|157|N|levels, ECG, eye exam) should be done while you are taking this||
2340|158|N|medication. Keep all medical and lab appointments.||
2340|159|B|||
2340|160|D|MISSED DOSE:  If you miss a dose, take it with food as soon as||
2340|161|D|you remember. If it is less than 8 hours before the next dose,||
2340|162|D|skip the missed dose. Take your next dose at the regular time. Do||
2340|163|D|not double the dose to catch up.||
2340|164|B|||
2340|165|R|STORAGE:  Store at room temperature away from light and moisture.||
2340|166|R|Do not store in the bathroom. Keep all medications away from||
2340|167|R|children and pets.||
2340|168|R|   Do not flush medications down the toilet or pour them into a||
2340|169|R|drain unless instructed to do so. Properly discard this product||
2340|170|R|when it is expired or no longer needed. Consult your pharmacist||
2340|171|R|or local waste disposal company.||
2340|172|B|||
2340|173|A|Information last revised April 2025.||
2340|174|A|Copyright(c) 2025 First Databank, Inc.||
2340|175|B|||
2341|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2341|002|Z|does NOT have all possible information about this product. This||
2341|003|Z|information does not assure that this product is safe, effective,||
2341|004|Z|or appropriate for you. This information is not individual||
2341|005|Z|medical advice and does not substitute for the advice of your||
2341|006|Z|health care professional. Always ask your health care||
2341|007|Z|professional for complete information about this product and your||
2341|008|Z|specific health needs.||
2341|009|B|||
2341|010|T|LEUPROLIDE 4 MONTH (30 MG) - SUBCUTANEOUS INJECTION||
2341|011|F|(LOO-proe-lide)||
2341|012|B|||
2341|013|C|COMMON BRAND NAME(S): Eligard||
2341|014|B|||
2341|015|U|USES:  Leuprolide is used to treat advanced prostate cancer. It||
2341|016|U|is not a cure. Most types of prostate cancer need the hormone||
2341|017|U|testosterone to grow and spread. Leuprolide works by reducing the||
2341|018|U|amount of testosterone that the body makes. This helps slow or||
2341|019|U|stop the growth of cancer cells and helps relieve symptoms such||
2341|020|U|as painful/difficult urination. Talk to your doctor about the||
2341|021|U|risks and benefits of treatment.||
2341|022|B|||
2341|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2341|024|H|from your pharmacist before you start using leuprolide and each||
2341|025|H|time you get a refill. If you have any questions, ask your doctor||
2341|026|H|or pharmacist.||
2341|027|H|   This medication is given by injection under the skin by a||
2341|028|H|healthcare professional as directed by your doctor, usually once||
2341|029|H|every 4 months. This product slowly releases the medication into||
2341|030|H|your blood over a 4-month period.||
2341|031|H|   Use this medication regularly to get the most benefit from it.||
2341|032|H|To help you remember, mark your calendar with a reminder.||
2341|033|H|   During the first few weeks of treatment, your hormone levels||
2341|034|H|will actually go up before they go down. This is a normal||
2341|035|H|response to this medication. Your symptoms may get worse for a||
2341|036|H|few weeks. If you have prostate cancer that has spread to the||
2341|037|H|spine or caused urinary blockage, you may require closer||
2341|038|H|monitoring by your doctor, especially when you first start||
2341|039|H|treatment. Tell your doctor right away if you have any bone pain,||
2341|040|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
2341|041|H|painful/difficult urination, unusual weakness, or inability to||
2341|042|H|move.||
2341|043|B|||
2341|044|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
2341|045|S|sweats, tiredness, swelling of the ankles/feet, increased||
2341|046|S|urination at night, dizziness, or mild burning/pain/bruising at||
2341|047|S|the injection site may occur. If any of these effects last or get||
2341|048|S|worse, tell your doctor or pharmacist promptly.||
2341|049|S|   Rarely, shrinking of the testicles, breast||
2341|050|S|tenderness/swelling, or reduced sexual interest/ability may also||
2341|051|S|occur as a result of lowered testosterone levels. Talk to your||
2341|052|S|doctor if these effects occur.||
2341|053|S|   Remember that this medication has been prescribed because your||
2341|054|S|doctor has judged that the benefit to you is greater than the||
2341|055|S|risk of side effects. Many people using this medication do not||
2341|056|S|have serious side effects.||
2341|057|S|   Tell your doctor right away if you have any serious side||
2341|058|S|effects, including: new/worsening bone pain, easily broken bones,||
2341|059|S|increased thirst/urination, mental/mood changes (such as||
2341|060|S|depression, thoughts of suicide, mood swings, aggression), signs||
2341|061|S|of liver disease (such as nausea/vomiting that doesn't stop, loss||
2341|062|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2341|063|S|urine).||
2341|064|S|   Get medical help right away if you have any very serious side||
2341|065|S|effects, including: symptoms of a heart attack (such as||
2341|066|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
2341|067|S|signs of a stroke (such as weakness on one side of the body,||
2341|068|S|trouble speaking, sudden vision changes, confusion), seizures,||
2341|069|S|fast/irregular heartbeat, severe dizziness, fainting.||
2341|070|S|   A very serious allergic reaction to this drug is rare.||
2341|071|S|However, get medical help right away if you notice any symptoms||
2341|072|S|of a serious allergic reaction, including: fever, swollen lymph||
2341|073|S|nodes, rash, itching/swelling (especially of the||
2341|074|S|face/tongue/throat), severe dizziness, trouble breathing.||
2341|075|S|   This is not a complete list of possible side effects. If you||
2341|076|S|notice other effects not listed above, contact your doctor or||
2341|077|S|pharmacist.||
2341|078|S|   In the US -||
2341|079|S|   Call your doctor for medical advice about side effects. You||
2341|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2341|081|S|www.fda.gov/medwatch.||
2341|082|S|   In Canada - Call your doctor for medical advice about side||
2341|083|S|effects. You may report side effects to Health Canada at||
2341|084|S|1-866-234-2345.||
2341|085|B|||
2341|086|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
2341|087|P|pharmacist if you are allergic to it; or to similar drugs (such||
2341|088|P|as histrelin, triptorelin); or if you have any other allergies.||
2341|089|P|This product may contain inactive ingredients, which can cause||
2341|090|P|allergic reactions or other problems. Talk to your pharmacist for||
2341|091|P|more details.||
2341|092|P|   Before using this medication, tell your doctor or pharmacist||
2341|093|P|your medical history, especially of: diabetes, heart disease||
2341|094|P|(such as heart attack), stroke, high cholesterol, mental/mood||
2341|095|P|problems (such as depression), seizures.||
2341|096|P|   Leuprolide may weaken your bones and increase your risk for||
2341|097|P|bone loss (osteoporosis) if used for a long time. Before using||
2341|098|P|this medication, tell your doctor or pharmacist if you have||
2341|099|P|osteoporosis or if you have any of the following risk factors for||
2341|100|P|osteoporosis: long-term alcohol use, smoking, family history of||
2341|101|P|osteoporosis and broken bones, use of certain medications (for||
2341|102|P|example, corticosteroids such as prednisone, certain anti-seizure||
2341|103|P|drugs such as phenytoin).||
2341|104|P|   Leuprolide may cause a condition that affects the heart rhythm||
2341|105|P|(QT prolongation). QT prolongation can rarely cause serious||
2341|106|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2341|107|P|as severe dizziness, fainting) that need medical attention right||
2341|108|P|away.||
2341|109|P|   The risk of QT prolongation may be increased if you have||
2341|110|P|certain medical conditions or are taking other drugs that may||
2341|111|P|cause QT prolongation. Before using leuprolide, tell your doctor||
2341|112|P|or pharmacist of all the drugs you take and if you have any of||
2341|113|P|the following conditions: certain heart problems (heart failure,||
2341|114|P|slow heartbeat, QT prolongation in the EKG), family history of||
2341|115|P|certain heart problems (QT prolongation in the EKG, sudden||
2341|116|P|cardiac death).||
2341|117|P|   Low levels of potassium or magnesium in the blood may also||
2341|118|P|increase your risk of QT prolongation. This risk may increase if||
2341|119|P|you use certain drugs (such as diuretics/"water pills") or if you||
2341|120|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2341|121|P|Talk to your doctor about using leuprolide safely.||
2341|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2341|123|P|can make you more dizzy. Do not drive, use machinery, or do||
2341|124|P|anything that needs alertness until you can do it safely. Limit||
2341|125|P|alcoholic beverages. Talk to your doctor if you are using||
2341|126|P|marijuana (cannabis).||
2341|127|P|   Before having surgery, tell your doctor or dentist about all||
2341|128|P|the products you use (including prescription drugs,||
2341|129|P|nonprescription drugs, and herbal products).||
2341|130|P|   Older adults may be more sensitive to the side effects of this||
2341|131|P|drug, especially QT prolongation (see above).||
2341|132|P|   This medication can affect fertility in males. Ask your doctor||
2341|133|P|for more details.||
2341|134|P|   This medication must not be used during pregnancy. It may harm||
2341|135|P|an unborn baby. It is important to prevent pregnancy while using||
2341|136|P|this medication. Consult your doctor for more details and to||
2341|137|P|discuss using reliable forms of non-hormonal birth control (such||
2341|138|P|as condoms, diaphragm with spermicide) while using this||
2341|139|P|medication. If you become pregnant or think you may be pregnant,||
2341|140|P|tell your doctor right away.||
2341|141|P|   It is unknown if leuprolide passes into breast milk. Because||
2341|142|P|of the possible risk to the infant, breastfeeding is not||
2341|143|P|recommended while using this medication. Consult your doctor||
2341|144|P|before breastfeeding.||
2341|145|B|||
2341|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2341|147|I|medications work or increase your risk for serious side effects.||
2341|148|I|This document does not contain all possible drug interactions.||
2341|149|I|Keep a list of all the products you use (including||
2341|150|I|prescription/nonprescription drugs and herbal products) and share||
2341|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
2341|152|I|the dosage of any medicines without your doctor's approval.||
2341|153|I|   This medication may interfere with certain lab tests, possibly||
2341|154|I|causing false test results. Make sure lab personnel and all your||
2341|155|I|doctors know you use this drug.||
2341|156|B|||
2341|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2341|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2341|159|O|poison control center right away. US residents can call||
2341|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2341|161|B|||
2341|162|N|NOTES:  Do not share this medication with others.||
2341|163|N|   Lab and/or medical tests (such as blood testosterone level,||
2341|164|N|PSA blood test, blood glucose, cholesterol/triglyceride levels)||
2341|165|N|should be done while you are using this medication. Keep all||
2341|166|N|medical and lab appointments. Consult your doctor for more||
2341|167|N|details.||
2341|168|B|||
2341|169|D|MISSED DOSE:  It is important to get each dose of this medication||
2341|170|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
2341|171|D|right away for a new dosing schedule. Do not double the dose to||
2341|172|D|catch up.||
2341|173|B|||
2341|174|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2341|175|R|doctor's office and will not be stored at home.||
2341|176|B|||
2341|177|A|Information last revised October 2024.||
2341|178|A|Copyright(c) 2025 First Databank, Inc.||
2341|179|B|||
2342|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2342|002|Z|does NOT have all possible information about this product. This||
2342|003|Z|information does not assure that this product is safe, effective,||
2342|004|Z|or appropriate for you. This information is not individual||
2342|005|Z|medical advice and does not substitute for the advice of your||
2342|006|Z|health care professional. Always ask your health care||
2342|007|Z|professional for complete information about this product and your||
2342|008|Z|specific health needs.||
2342|009|B|||
2342|010|T|CABOTEGRAVIR - ORAL||
2342|011|F|(KA-boe-TEG-ra-vir)||
2342|012|B|||
2342|013|C|COMMON BRAND NAME(S): Vocabria||
2342|014|B|||
2342|015|U|USES:  Cabotegravir is used with another HIV medication||
2342|016|U|(rilpivirine) for short-term treatment to replace other||
2342|017|U|medication(s) used to help control HIV infection. Cabotegravir is||
2342|018|U|also used by itself for short-term treatment to help prevent HIV||
2342|019|U|infection in people who have a high risk for infection.||
2342|020|U|Short-term treatment (usually for 1 month) is used to see how||
2342|021|U|well you can take this medication before using the long-acting||
2342|022|U|form. This form of cabotegravir may also be used if you will miss||
2342|023|U|a planned injection of the long-acting form of this medication.||
2342|024|U|Cabotegravir helps to decrease the amount of HIV in your body so||
2342|025|U|your immune system can work better. This lowers your chance of||
2342|026|U|getting HIV complications (such as new infections, cancer) and||
2342|027|U|improves your quality of life. Cabotegravir belongs to a class of||
2342|028|U|drugs known as integrase inhibitors. It blocks the virus from||
2342|029|U|growing and infecting more cells.||
2342|030|U|   Cabotegravir is not a cure for HIV infection. To decrease your||
2342|031|U|risk of spreading HIV disease to others, continue to take all HIV||
2342|032|U|medications exactly as prescribed by your doctor. Use an||
2342|033|U|effective barrier method (latex or polyurethane condoms/dental||
2342|034|U|dams) during sexual activity as directed by your doctor. Do not||
2342|035|U|share personal items (such as needles/syringes, toothbrushes, and||
2342|036|U|razors) that may have contacted blood or other body fluids.||
2342|037|U|Consult your doctor or pharmacist for more details.||
2342|038|B|||
2342|039|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2342|040|H|from your pharmacist before you start using cabotegravir and each||
2342|041|H|time you get a refill. If you have any questions, ask your doctor||
2342|042|H|or pharmacist.||
2342|043|H|   Take this medication by mouth with or without food as directed||
2342|044|H|by your doctor, usually once daily. If you are taking||
2342|045|H|cabotegravir at the same time as rilpivirine, take it with a||
2342|046|H|meal. The dosage and treatment schedule are based on your medical||
2342|047|H|condition and response to treatment.||
2342|048|H|   Take this medication at least 4 hours before or 2 hours after||
2342|049|H|products that contain aluminum, magnesium, or calcium (such as||
2342|050|H|antacids, mineral/vitamin supplements). These products may make||
2342|051|H|cabotegravir not work well.||
2342|052|H|   If you are taking this medication to prevent HIV infection,||
2342|053|H|you must first get tested to be sure you are HIV-negative. Your||
2342|054|H|doctor will perform lab tests before starting this medication and||
2342|055|H|periodically during treatment to make sure that you do not have||
2342|056|H|HIV infection. Using this product will not always prevent HIV||
2342|057|H|infection. To get the most benefit from it, take this product||
2342|058|H|exactly as directed, and follow all prevention actions. (See also||
2342|059|H|Uses section.) Tell your doctor right away if you have any signs||
2342|060|H|of HIV infection (such as sore throat that doesn't go away,||
2342|061|H|tiredness, fever, night sweats, diarrhea, joint/muscle aches,||
2342|062|H|swollen lymph nodes).||
2342|063|H|   Do not take more or less of this drug than prescribed or stop||
2342|064|H|taking it (or other HIV medicines) even for a short time unless||
2342|065|H|directed to do so by your doctor. Doing so may cause the amount||
2342|066|H|of virus to increase, make the infection more difficult to treat||
2342|067|H|(resistant), or worsen side effects.||
2342|068|H|   For the best effect, take this medication at evenly spaced||
2342|069|H|times. To help you remember, take this medication at the same||
2342|070|H|time every day.||
2342|071|B|||
2342|072|S|SIDE EFFECTS:  Headache, nausea, dizziness, anxiety, or trouble||
2342|073|S|sleeping may occur. If any of these effects last or get worse,||
2342|074|S|tell your doctor or pharmacist promptly.||
2342|075|S|   Remember that this medication has been prescribed because your||
2342|076|S|doctor has judged that the benefit to you is greater than the||
2342|077|S|risk of side effects. Many people using this medication do not||
2342|078|S|have serious side effects.||
2342|079|S|   As your immune system gets stronger, it can begin to fight off||
2342|080|S|infections you already had, possibly causing disease symptoms to||
2342|081|S|come back. You could also have symptoms if your immune system||
2342|082|S|becomes overactive. This reaction may happen at any time (soon||
2342|083|S|after starting HIV treatment or many months later). Tell your||
2342|084|S|doctor right away if you have any serious symptoms, including:||
2342|085|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
2342|086|S|that doesn't go away, headaches that are severe or don't go away,||
2342|087|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
2342|088|S|changes, signs of infection (such as sore throat that doesn't go||
2342|089|S|away, fever, chills, swollen lymph nodes, non-healing skin||
2342|090|S|sores), signs of an overactive thyroid (such as irritability,||
2342|091|S|nervousness, heat intolerance, fast/pounding/irregular||
2342|092|S|heartbeat), signs of liver disease (such as nausea/vomiting that||
2342|093|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
2342|094|S|eyes/skin, dark urine).||
2342|095|S|   Tell your doctor right away if you have any serious side||
2342|096|S|effects, including: mental/mood changes (such as depression,||
2342|097|S|thoughts of suicide).||
2342|098|S|   A very serious allergic reaction to this drug is rare.||
2342|099|S|However, get medical help right away if you notice any symptoms||
2342|100|S|of a serious allergic reaction, including: rash, itching/swelling||
2342|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2342|102|S|breathing.||
2342|103|S|   This is not a complete list of possible side effects. If you||
2342|104|S|notice other effects not listed above, contact your doctor or||
2342|105|S|pharmacist.||
2342|106|S|   In the US -||
2342|107|S|   Call your doctor for medical advice about side effects. You||
2342|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2342|109|S|www.fda.gov/medwatch.||
2342|110|S|   In Canada - Call your doctor for medical advice about side||
2342|111|S|effects. You may report side effects to Health Canada at||
2342|112|S|1-866-234-2345.||
2342|113|B|||
2342|114|P|PRECAUTIONS:  Before taking cabotegravir, tell your doctor or||
2342|115|P|pharmacist if you are allergic to it; or if you have any other||
2342|116|P|allergies. This product may contain inactive ingredients, which||
2342|117|P|can cause allergic reactions or other problems. Talk to your||
2342|118|P|pharmacist for more details.||
2342|119|P|   Before using this medication, tell your doctor or pharmacist||
2342|120|P|your medical history, especially of: liver disease (such as||
2342|121|P|hepatitis B, hepatitis C), mental/mood disorders (such as||
2342|122|P|depression).||
2342|123|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2342|124|P|can make you more dizzy. Do not drive, use machinery, or do||
2342|125|P|anything that needs alertness until you can do it safely. Limit||
2342|126|P|alcoholic beverages. Talk to your doctor if you are using||
2342|127|P|marijuana (cannabis).||
2342|128|P|   Before having surgery, tell your doctor or dentist about all||
2342|129|P|the products you use (including prescription drugs,||
2342|130|P|nonprescription drugs, and herbal products).||
2342|131|P|   Tell your doctor if you are pregnant before using this||
2342|132|P|medication. Treatment can lower the risk of passing HIV infection||
2342|133|P|to your baby. Discuss the risks and benefits with your doctor.||
2342|134|P|   It is unknown if this medication passes into breast milk.||
2342|135|P|Because breast milk may transmit HIV, consult your doctor before||
2342|136|P|breastfeeding.||
2342|137|B|||
2342|138|I|DRUG INTERACTIONS:  See also How to Use section.||
2342|139|I|   Drug interactions may change how your medications work or||
2342|140|I|increase your risk for serious side effects. This document does||
2342|141|I|not contain all possible drug interactions. Keep a list of all||
2342|142|I|the products you use (including prescription/nonprescription||
2342|143|I|drugs and herbal products) and share it with your doctor and||
2342|144|I|pharmacist. Do not start, stop, or change the dosage of any||
2342|145|I|medicines without your doctor's approval.||
2342|146|I|   Other medications can affect the removal of cabotegravir from||
2342|147|I|your body, which may affect how cabotegravir works. Examples||
2342|148|I|include efavirenz, rifamycins (such as rifampin, rifapentine),||
2342|149|I|ritonavir, certain drugs used to treat seizures (such as||
2342|150|I|carbamazepine, oxcarbazepine, phenobarbital, phenytoin,||
2342|151|I|primidone), among others.||
2342|152|I|   This medication can slow down the removal of other medications||
2342|153|I|from your body, which may affect how they work. An example of an||
2342|154|I|affected drug is ketorolac, among others.||
2342|155|B|||
2342|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2342|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2342|158|O|poison control center right away. US residents can call||
2342|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2342|160|B|||
2342|161|N|NOTES:  Do not share this medication with others.||
2342|162|N|   Lab and/or medical tests (such as viral load, T-cell counts,||
2342|163|N|liver function) should be done while you are taking this||
2342|164|N|medication. Keep all medical and lab appointments.||
2342|165|B|||
2342|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2342|167|D|remember. If it is near the time of the next dose, skip the||
2342|168|D|missed dose. Take your next dose at the regular time. Do not||
2342|169|D|double the dose to catch up.||
2342|170|B|||
2342|171|R|STORAGE:  Store at room temperature away from light and moisture.||
2342|172|R|Do not store in the bathroom. Keep all medications away from||
2342|173|R|children and pets.||
2342|174|R|   Do not flush medications down the toilet or pour them into a||
2342|175|R|drain unless instructed to do so. Properly discard this product||
2342|176|R|when it is expired or no longer needed. Consult your pharmacist||
2342|177|R|or local waste disposal company.||
2342|178|B|||
2342|179|A|Information last revised July 2025.||
2342|180|A|Copyright(c) 2025 First Databank, Inc.||
2342|181|B|||
2343|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2343|002|Z|does NOT have all possible information about this product. This||
2343|003|Z|information does not assure that this product is safe, effective,||
2343|004|Z|or appropriate for you. This information is not individual||
2343|005|Z|medical advice and does not substitute for the advice of your||
2343|006|Z|health care professional. Always ask your health care||
2343|007|Z|professional for complete information about this product and your||
2343|008|Z|specific health needs.||
2343|009|B|||
2343|010|T|CABOTEGRAVIR/RILPIVIRINE EXTENDED-RELEASE - INJECTION||
2343|011|F|(KA-boe-TEG-ra-vir/RIL-pi-VIR-een)||
2343|012|B|||
2343|013|C|COMMON BRAND NAME(S): Cabenuva||
2343|014|B|||
2343|015|U|USES:  This product is used to help control HIV infection. It||
2343|016|U|contains 2 medications: cabotegravir and rilpivirine. It helps to||
2343|017|U|decrease the amount of HIV in your body so your immune system can||
2343|018|U|work better. This lowers your chance of getting HIV complications||
2343|019|U|(such as new infections, cancer) and improves your quality of||
2343|020|U|life. Cabotegravir is an integrase inhibitor while rilpivirine is||
2343|021|U|a non-nucleoside reverse transcriptase inhibitor (NNRTI). Both||
2343|022|U|drugs block the virus from growing and infecting more cells.||
2343|023|U|   Cabotegravir/rilpivirine is not a cure for HIV infection. To||
2343|024|U|decrease your risk of spreading HIV disease to others, continue||
2343|025|U|to take all HIV medications exactly as prescribed by your doctor.||
2343|026|U|Use an effective barrier method (latex or polyurethane||
2343|027|U|condoms/dental dams) during sexual activity as directed by your||
2343|028|U|doctor. Do not share personal items (such as needles/syringes,||
2343|029|U|toothbrushes, and razors) that may have contacted blood or other||
2343|030|U|body fluids. Consult your doctor or pharmacist for more details.||
2343|031|B|||
2343|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2343|033|H|from your pharmacist before you start using||
2343|034|H|cabotegravir/rilpivirine and each time you get a refill. If you||
2343|035|H|have any questions, ask your doctor or pharmacist.||
2343|036|H|   Before starting treatment with this product, your health care||
2343|037|H|professional may have you take the forms of cabotegravir and||
2343|038|H|rilpivirine taken by mouth for one month (at least 28 days). This||
2343|039|H|is to see how well you can take these medications.||
2343|040|H|   This product is given by injection into a muscle as directed||
2343|041|H|by your doctor, usually once every month or once every 2 months.||
2343|042|H|It is given by 2 injections, usually one on each side of your||
2343|043|H|buttocks by a health care professional. The dosage is based on||
2343|044|H|your medical condition and response to treatment.||
2343|045|H|   It is very important to keep using these medications exactly||
2343|046|H|as prescribed by your doctor. To help you remember, mark your||
2343|047|H|calendar with a reminder. If you miss or will miss a planned||
2343|048|H|monthly injection, tell your health care professional right away||
2343|049|H|so that you may be given directions for your continued HIV||
2343|050|H|treatment.||
2343|051|B|||
2343|052|S|SIDE EFFECTS:  Injection site pain/discomfort, swelling, redness,||
2343|053|S|itching, bruising, or a hardened mass or lump may occur.||
2343|054|S|Headache, tiredness, nausea, or trouble sleeping may also occur.||
2343|055|S|If any of these effects last or get worse, tell your doctor or||
2343|056|S|pharmacist promptly.||
2343|057|S|   Rarely, temporary symptoms such as sweating, shortness of||
2343|058|S|breath, stomach cramps, dizziness/lightheadedness, or mouth||
2343|059|S|numbness have happened after receiving the injections. Most||
2343|060|S|symptoms stopped within a few minutes after the injection. Tell||
2343|061|S|your health care professional right away if you have any of these||
2343|062|S|symptoms soon after receiving an injection.||
2343|063|S|   Remember that this medication has been prescribed because your||
2343|064|S|doctor has judged that the benefit to you is greater than the||
2343|065|S|risk of side effects. Many people using this medication do not||
2343|066|S|have serious side effects.||
2343|067|S|   As your immune system gets stronger, it can begin to fight off||
2343|068|S|infections you already had, possibly causing disease symptoms to||
2343|069|S|come back. You could also have symptoms if your immune system||
2343|070|S|becomes overactive. This reaction may happen at any time (soon||
2343|071|S|after starting HIV treatment or many months later). Tell your||
2343|072|S|doctor right away if you have any serious symptoms, including:||
2343|073|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
2343|074|S|that doesn't go away, headaches that are severe or don't go away,||
2343|075|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
2343|076|S|changes, signs of infection (such as sore throat that doesn't go||
2343|077|S|away, fever, chills, non-healing skin sores), signs of an||
2343|078|S|overactive thyroid (such as irritability, nervousness, heat||
2343|079|S|intolerance, fast/pounding/irregular heartbeat), signs of liver||
2343|080|S|disease (such as nausea/vomiting that doesn't stop, loss of||
2343|081|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2343|082|S|urine).||
2343|083|S|   Tell your doctor right away if you have any serious side||
2343|084|S|effects, including: mental/mood changes (such as depression,||
2343|085|S|thoughts of suicide).||
2343|086|S|   Rilpivirine can commonly cause a rash that is usually not||
2343|087|S|serious. However, you may not be able to tell it apart from a||
2343|088|S|rare rash that could be a sign of a severe reaction. Get medical||
2343|089|S|help right away if you develop any rash.||
2343|090|S|   A very serious allergic reaction to this drug is rare.||
2343|091|S|However, get medical help right away if you notice any symptoms||
2343|092|S|of a serious allergic reaction, including: swollen lymph nodes,||
2343|093|S|rash, itching/swelling (especially of the face/tongue/throat),||
2343|094|S|severe dizziness, trouble breathing.||
2343|095|S|   This is not a complete list of possible side effects. If you||
2343|096|S|notice other effects not listed above, contact your doctor or||
2343|097|S|pharmacist.||
2343|098|S|   In the US -||
2343|099|S|   Call your doctor for medical advice about side effects. You||
2343|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2343|101|S|www.fda.gov/medwatch.||
2343|102|S|   In Canada - Call your doctor for medical advice about side||
2343|103|S|effects. You may report side effects to Health Canada at||
2343|104|S|1-866-234-2345.||
2343|105|B|||
2343|106|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2343|107|P|pharmacist if you are allergic to cabotegravir or rilpivirine; or||
2343|108|P|if you have any other allergies. This product may contain||
2343|109|P|inactive ingredients, which can cause allergic reactions or other||
2343|110|P|problems. Talk to your pharmacist for more details.||
2343|111|P|   Before using this medication, tell your doctor or pharmacist||
2343|112|P|your medical history, especially of: kidney disease, liver||
2343|113|P|disease (such as hepatitis B, hepatitis C), mental/mood disorders||
2343|114|P|(such as depression).||
2343|115|P|   Before having surgery, tell your doctor or dentist about all||
2343|116|P|the products you use (including prescription drugs,||
2343|117|P|nonprescription drugs, and herbal products).||
2343|118|P|   During pregnancy, this medication should be used only when||
2343|119|P|clearly needed. Treatment can lower the risk of passing HIV||
2343|120|P|infection to your baby, and cabotegravir/rilpivirine may be part||
2343|121|P|of that treatment. Discuss the risks and benefits with your||
2343|122|P|doctor.||
2343|123|P|   It is unknown if cabotegravir passes into breast milk.||
2343|124|P|Rilpivirine passes into breast milk. Because breast milk may||
2343|125|P|transmit HIV, consult your doctor before breastfeeding.||
2343|126|B|||
2343|127|I|DRUG INTERACTIONS:  See also How to Use section.||
2343|128|I|   Drug interactions may change how your medications work or||
2343|129|I|increase your risk for serious side effects. This document does||
2343|130|I|not contain all possible drug interactions. Keep a list of all||
2343|131|I|the products you use (including prescription/nonprescription||
2343|132|I|drugs and herbal products) and share it with your doctor and||
2343|133|I|pharmacist. Do not start, stop, or change the dosage of any||
2343|134|I|medicines without your doctor's approval.||
2343|135|I|   Do not use this medication with other products that treat HIV||
2343|136|I|infection. Do not use this medication with other products that||
2343|137|I|contain cabotegravir or rilpivirine.||
2343|138|I|   Other medications can affect the removal of||
2343|139|I|cabotegravir/rilpivirine from your body, which may affect how||
2343|140|I|this product works. Examples include apalutamide, dexamethasone,||
2343|141|I|enzalutamide, certain macrolide antibiotics (such as||
2343|142|I|clarithromycin, erythromycin), rifamycins (such as rifampin,||
2343|143|I|rifapentine), St. John's wort, certain drugs used to treat||
2343|144|I|seizures (such as carbamazepine, oxcarbazepine, phenobarbital,||
2343|145|I|phenytoin, primidone), among others.||
2343|146|I|   Cabotegravir can slow down the removal of other medications||
2343|147|I|from your body, which may affect how they work. An example of an||
2343|148|I|affected drug is ketorolac, among others.||
2343|149|B|||
2343|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2343|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2343|152|O|poison control center right away. US residents can call||
2343|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2343|154|O|Symptoms of overdose may include: fast/irregular heartbeat,||
2343|155|O|severe dizziness, fainting.||
2343|156|B|||
2343|157|N|NOTES:  Lab and/or medical tests (such as viral load, T-cell||
2343|158|N|counts, liver function) should be done while you are taking this||
2343|159|N|medication. Keep all medical and lab appointments. Consult your||
2343|160|N|doctor for more details.||
2343|161|B|||
2343|162|D|MISSED DOSE:  It is important to get each dose of this medication||
2343|163|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2343|164|D|right away for a new dosing schedule.||
2343|165|B|||
2343|166|R|STORAGE:  Not applicable. This product is given in a hospital or||
2343|167|R|clinic or doctor's office and will not be stored at home.||
2343|168|B|||
2343|169|A|Information last revised July 2025.||
2343|170|A|Copyright(c) 2025 First Databank, Inc.||
2343|171|B|||
2345|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2345|002|Z|does NOT have all possible information about this product. This||
2345|003|Z|information does not assure that this product is safe, effective,||
2345|004|Z|or appropriate for you. This information is not individual||
2345|005|Z|medical advice and does not substitute for the advice of your||
2345|006|Z|health care professional. Always ask your health care||
2345|007|Z|professional for complete information about this product and your||
2345|008|Z|specific health needs.||
2345|009|B|||
2345|010|T|MANNITOL POWDER IN CAPSULE - ORAL INHALATION||
2345|011|F|(MAN-i-tol)||
2345|012|B|||
2345|013|C|COMMON BRAND NAME(S): Bronchitol||
2345|014|B|||
2345|015|U|USES:  This medication is used to treat cystic fibrosis. Mannitol||
2345|016|U|may help to improve breathing.||
2345|017|B|||
2345|018|H|HOW TO USE:  Before starting treatment, your doctor should have||
2345|019|H|you use a test dose of mannitol (a smaller dose) in the office to||
2345|020|H|check for any breathing problems. Ask your doctor for more||
2345|021|H|details.||
2345|022|H|   Read the Patient Information Leaflet provided by your||
2345|023|H|pharmacist before you start using this medication and each time||
2345|024|H|you get a refill. Learn and follow the directions for proper use||
2345|025|H|and care of the inhaler device and this medication. If you have||
2345|026|H|any questions, ask your healthcare provider or pharmacist.||
2345|027|H|   Before using mannitol, use a quick-relief inhaler (such as||
2345|028|H|albuterol, also called salbutamol in some countries) 5 to 15||
2345|029|H|minutes before each dose of mannitol to reduce the risk of side||
2345|030|H|effects (such as wheezing).||
2345|031|H|   Mannitol comes in a capsule. Do not swallow the capsules.||
2345|032|H|Inhale the contents of the capsule by mouth using the inhaler||
2345|033|H|device as directed by your doctor, usually twice daily (once in||
2345|034|H|the morning and once at least 2 to 3 hours before bedtime). Each||
2345|035|H|dose is usually 10 of the 40-milligram capsules. This medication||
2345|036|H|must always be used with its own special inhaler device. Do not||
2345|037|H|use a "spacer" device with the inhaler.||
2345|038|H|   Leave the capsules sealed in the blister card until just||
2345|039|H|before use. Wash and completely dry hands before touching the||
2345|040|H|capsules. Inhale the capsule contents as directed to make sure||
2345|041|H|you inhale all of the drug. Load 1 capsule in the inhaler and be||
2345|042|H|sure to inhale quickly and deeply through the mouthpiece when||
2345|043|H|using this drug. You should hear the inhaler make a rattling||
2345|044|H|noise as you inhale the medication. Hold your breath for up to 5||
2345|045|H|seconds. Do not exhale or blow into the inhaler. Open the inhaler||
2345|046|H|to see if any powder is left in the capsule. If there is, close||
2345|047|H|the inhaler and inhale again. Inhale all of the powder from each||
2345|048|H|capsule. Remove the used capsule from the inhaler. Repeat with||
2345|049|H|another capsule and continue until you get the full dose.||
2345|050|H|   If you are using other inhalers at the same time, wait at||
2345|051|H|least one minute between the use of each medication.||
2345|052|H|   Use this medication regularly to get the most benefit from it.||
2345|053|H|To help you remember, use it at the same times each day. Do not||
2345|054|H|increase your dose, use this medication more often, or stop using||
2345|055|H|it without first consulting your doctor.||
2345|056|H|   Tell your doctor if your condition does not get better or if||
2345|057|H|it gets worse.||
2345|058|B|||
2345|059|S|SIDE EFFECTS:  Dry/irritated throat or coughing may occur. If||
2345|060|S|either of these effects lasts or gets worse, tell your doctor or||
2345|061|S|pharmacist promptly.||
2345|062|S|   Remember that this medication has been prescribed because your||
2345|063|S|doctor has judged that the benefit to you is greater than the||
2345|064|S|risk of side effects. Many people using this medication do not||
2345|065|S|have serious side effects.||
2345|066|S|   Rarely, this medication may cause sudden breathing||
2345|067|S|problems/wheezing right after you use it. If this occurs, use||
2345|068|S|your quick-relief inhaler and get medical help right away.||
2345|069|S|   Tell your doctor right away if you have any serious side||
2345|070|S|effects, including: coughing up blood.||
2345|071|S|   A very serious allergic reaction to this drug is rare.||
2345|072|S|However, get medical help right away if you notice any symptoms||
2345|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2345|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2345|075|S|breathing.||
2345|076|S|   This is not a complete list of possible side effects. If you||
2345|077|S|notice other effects not listed above, contact your doctor or||
2345|078|S|pharmacist.||
2345|079|S|   In the US -||
2345|080|S|   Call your doctor for medical advice about side effects. You||
2345|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2345|082|S|www.fda.gov/medwatch.||
2345|083|S|   In Canada - Call your doctor for medical advice about side||
2345|084|S|effects. You may report side effects to Health Canada at||
2345|085|S|1-866-234-2345.||
2345|086|B|||
2345|087|P|PRECAUTIONS:  Before using mannitol, tell your doctor or||
2345|088|P|pharmacist if you are allergic to it; or if you have any other||
2345|089|P|allergies. This product may contain inactive ingredients, which||
2345|090|P|can cause allergic reactions or other problems. Talk to your||
2345|091|P|pharmacist for more details.||
2345|092|P|   Before using this medication, tell your doctor or pharmacist||
2345|093|P|your medical history, especially of: coughing up blood.||
2345|094|P|   Before having surgery, tell your doctor or dentist about all||
2345|095|P|the products you use (including prescription drugs,||
2345|096|P|nonprescription drugs, and herbal products).||
2345|097|P|   During pregnancy, this medication should be used only when||
2345|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
2345|099|P|   It is unknown if this medication passes into breast milk.||
2345|100|P|Consult your doctor before breastfeeding.||
2345|101|B|||
2345|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2345|103|I|medications work or increase your risk for serious side effects.||
2345|104|I|This document does not contain all possible drug interactions.||
2345|105|I|Keep a list of all the products you use (including||
2345|106|I|prescription/nonprescription drugs and herbal products) and share||
2345|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
2345|108|I|the dosage of any medicines without your doctor's approval.||
2345|109|B|||
2345|110|O|OVERDOSE:  This medication will not work and may be harmful if||
2345|111|O|swallowed. If someone has overdosed and has serious symptoms such||
2345|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2345|113|O|poison control center right away. US residents can call||
2345|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2345|115|B|||
2345|116|N|NOTES:  Do not share this medication with others.||
2345|117|N|   Lab and/or medical tests (such as lung function) may be done||
2345|118|N|while you are using this medication. Keep all medical and lab||
2345|119|N|appointments.||
2345|120|B|||
2345|121|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2345|122|D|If it is near the time of the next dose, skip the missed dose.||
2345|123|D|Use your next dose at the regular time. Do not double the dose to||
2345|124|D|catch up.||
2345|125|B|||
2345|126|R|STORAGE:  Store at room temperature. Do not refrigerate or||
2345|127|R|freeze. Keep the inhaler device dry and discard the inhaler||
2345|128|R|device after 7 days of use. Keep all medications away from||
2345|129|R|children and pets.||
2345|130|R|   Do not flush medications down the toilet or pour them into a||
2345|131|R|drain unless instructed to do so. Properly discard this product||
2345|132|R|when it is expired or no longer needed. Consult your pharmacist||
2345|133|R|or local waste disposal company.||
2345|134|B|||
2345|135|M|MEDICAL ALERT:  Your condition can cause complications in a||
2345|136|M|medical emergency. For information about enrolling in MedicAlert,||
2345|137|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2345|138|B|||
2345|139|A|Information last revised March 2025.||
2345|140|A|Copyright(c) 2025 First Databank, Inc.||
2345|141|B|||
2346|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2346|002|Z|does NOT have all possible information about this product. This||
2346|003|Z|information does not assure that this product is safe, effective,||
2346|004|Z|or appropriate for you. This information is not individual||
2346|005|Z|medical advice and does not substitute for the advice of your||
2346|006|Z|health care professional. Always ask your health care||
2346|007|Z|professional for complete information about this product and your||
2346|008|Z|specific health needs.||
2346|009|B|||
2346|010|T|COVID-19 VACCINE (PFIZER-BIONTECH) - INJECTION||
2346|011|B|||
2346|012|C|COMMON BRAND NAME(S): Comirnaty||
2346|013|B|||
2346|014|U|USES:  This vaccine is used to help prevent coronavirus disease,||
2346|015|U|also known as COVID-19. It works by increasing the body's natural||
2346|016|U|defense (immunity) against the virus. This vaccine may prevent||
2346|017|U|the illness, or reduce the seriousness of it.||
2346|018|U|   Vaccines may not fully protect everyone who receives them.||
2346|019|B|||
2346|020|H|HOW TO USE:  Read all vaccine information available from your||
2346|021|H|health care professional before receiving the vaccine. If you||
2346|022|H|have any questions, ask your health care professional.||
2346|023|H|   This vaccine is given by injection into a muscle by a health||
2346|024|H|care professional. It is given in the upper arm for children and||
2346|025|H|adults and in the thigh for infants. Closely follow the||
2346|026|H|vaccination schedule provided by the health care professional. To||
2346|027|H|help you remember, mark your calendar with a reminder.||
2346|028|B|||
2346|029|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
2346|030|S|tiredness, headache, fever, muscle/joint pain, chills, or swollen||
2346|031|S|lymph nodes may occur. If any of these effects last or get worse,||
2346|032|S|tell your health care professional promptly.||
2346|033|S|   Rarely, some people have symptoms such as fainting, dizziness,||
2346|034|S|vision changes, or ringing in the ears just after getting a||
2346|035|S|vaccine injection. Tell your health care professional right away||
2346|036|S|if you have any of these symptoms. Sitting or lying down may||
2346|037|S|help, since these symptoms usually don't last long.||
2346|038|S|   Remember that this vaccine has been prescribed because your||
2346|039|S|health care professional has judged that the benefit to you is||
2346|040|S|greater than the risk of side effects. Many people using this||
2346|041|S|vaccine do not have serious side effects.||
2346|042|S|   There have been rare reports of swelling of the heart muscle||
2346|043|S|(myocarditis) or the lining of the heart (pericarditis) that||
2346|044|S|usually occurred within a week after receiving this vaccine,||
2346|045|S|especially after the second dose. If you notice any of the||
2346|046|S|following symptoms, get medical help right away: chest pain,||
2346|047|S|shortness of breath, fast/pounding heartbeat.||
2346|048|S|   A very serious allergic reaction to this vaccine is rare. Get||
2346|049|S|medical help right away if you notice any symptoms of a serious||
2346|050|S|allergic reaction, including: rash, itching/swelling (especially||
2346|051|S|of the face/tongue/throat), severe dizziness, trouble breathing.||
2346|052|S|   This is not a complete list of possible side effects. If you||
2346|053|S|notice other effects not listed above, contact your health care||
2346|054|S|professional.||
2346|055|S|   Contact the doctor for medical advice about side effects. The||
2346|056|S|following numbers do not provide medical advice, but in the US||
2346|057|S|you may report side effects to the Vaccine Adverse Event||
2346|058|S|Reporting System (VAERS) at 1-800-822-7967. In Canada, you may||
2346|059|S|call the Vaccine Safety Section at Public Health Agency of Canada||
2346|060|S|at 1-866-844-0018.||
2346|061|B|||
2346|062|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
2346|063|P|care professional if you are allergic to it; or to polysorbate;||
2346|064|P|or if you have any other allergies. This product may contain||
2346|065|P|inactive ingredients (such as polyethylene glycol), which can||
2346|066|P|cause allergic reactions or other problems. Talk to your||
2346|067|P|pharmacist for more details.||
2346|068|P|   Before receiving this vaccine, tell your health care||
2346|069|P|professional your medical history, especially of: current||
2346|070|P|fever/illness, immune system disorders (such as those due to||
2346|071|P|cancer/radiation treatment), certain heart problems (myocarditis,||
2346|072|P|pericarditis), vaccination history (including previous reactions||
2346|073|P|to any vaccines).||
2346|074|P|   Tell your doctor if you are pregnant before using this||
2346|075|P|vaccine.||
2346|076|P|   It is unknown if this vaccine passes into breast milk. Consult||
2346|077|P|your health care professional before breastfeeding.||
2346|078|B|||
2346|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2346|080|I|medications work or increase your risk for serious side effects.||
2346|081|I|This document does not contain all possible drug interactions.||
2346|082|I|Keep a list of all the products you use (including||
2346|083|I|prescription/nonprescription drugs and herbal products) and share||
2346|084|I|it with your health care professional. Do not start, stop, or||
2346|085|I|change the dosage of any medicines without your doctor's||
2346|086|I|approval.||
2346|087|I|   Some products that may interact with this vaccine are: drugs||
2346|088|I|that weaken the immune system (including cyclosporine,||
2346|089|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
2346|090|I|prednisone).||
2346|091|B|||
2346|092|O|OVERDOSE:  Not applicable.||
2346|093|B|||
2346|094|N|NOTES:  Keep all medical and lab appointments.||
2346|095|N|   Keep vaccine records for yourself and your children and||
2346|096|N|provide them to the health care professionals to prevent||
2346|097|N|unnecessary re-vaccinations.||
2346|098|B|||
2346|099|D|MISSED DOSE:  It is important that you get each vaccination as||
2346|100|D|scheduled. Ask when you should get each dose and mark your||
2346|101|D|calendar with a reminder. If you miss a dose, call the health||
2346|102|D|care professional to reschedule.||
2346|103|B|||
2346|104|R|STORAGE:  Not applicable. This vaccine is given in a hospital or||
2346|105|R|clinic and will not be stored at home.||
2346|106|B|||
2346|107|A|Information last revised June 2025.||
2346|108|A|Copyright(c) 2025 First Databank, Inc.||
2346|109|B|||
2347|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2347|002|Z|does NOT have all possible information about this product. This||
2347|003|Z|information does not assure that this product is safe, effective,||
2347|004|Z|or appropriate for you. This information is not individual||
2347|005|Z|medical advice and does not substitute for the advice of your||
2347|006|Z|health care professional. Always ask your health care||
2347|007|Z|professional for complete information about this product and your||
2347|008|Z|specific health needs.||
2347|009|B|||
2347|010|T|BELUMOSUDIL - ORAL||
2347|011|F|(BEL-ue-MOE-soo-dil)||
2347|012|B|||
2347|013|C|COMMON BRAND NAME(S): Rezurock||
2347|014|B|||
2347|015|U|USES:  Belumosudil is used to treat a certain problem that may||
2347|016|U|occur after a stem cell transplant (chronic graft-versus-host||
2347|017|U|disease). Belumosudil belongs to a class of drugs known as kinase||
2347|018|U|inhibitors. It works by blocking some of your immune system's||
2347|019|U|responses which may cause swelling and scarring of certain organs||
2347|020|U|or parts of the body.||
2347|021|B|||
2347|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2347|023|H|from your pharmacist before you start taking belumosudil and each||
2347|024|H|time you get a refill. If you have any questions, ask your doctor||
2347|025|H|or pharmacist.||
2347|026|H|   Take this medication by mouth with a meal as directed by your||
2347|027|H|doctor, usually once daily. Swallow the tablets whole. Do not||
2347|028|H|cut, crush, or chew the tablets.||
2347|029|H|   The dosage is based on your medical condition, response to||
2347|030|H|treatment, and other medications you may be taking. Be sure to||
2347|031|H|tell your doctor and pharmacist about all the products you use||
2347|032|H|(including prescription drugs, nonprescription drugs, and herbal||
2347|033|H|products).||
2347|034|H|   Use this medication regularly to get the most benefit from it.||
2347|035|H|To help you remember, take it at the same time each day.||
2347|036|H|   Do not increase your dose or take this medication more often||
2347|037|H|than prescribed. Your condition will not improve any faster, and||
2347|038|H|your risk of serious side effects will increase.||
2347|039|H|   Tell your doctor if you do not get better or if you get worse.||
2347|040|B|||
2347|041|S|SIDE EFFECTS:  Diarrhea, nausea, abdominal pain, decreased||
2347|042|S|appetite, headache, joint/muscle pain, swelling||
2347|043|S|ankles/feet/hands, shortness of breath, cough, or tiredness may||
2347|044|S|occur. If any of these effects last or get worse, tell your||
2347|045|S|doctor or pharmacist promptly.||
2347|046|S|   Remember that this medication has been prescribed because your||
2347|047|S|doctor has judged that the benefit to you is greater than the||
2347|048|S|risk of side effects. Many people using this medication do not||
2347|049|S|have serious side effects.||
2347|050|S|   This medication may raise your blood pressure. Check your||
2347|051|S|blood pressure regularly and tell your doctor if the results are||
2347|052|S|high. Your doctor may control your blood pressure with||
2347|053|S|medication.||
2347|054|S|   Tell your doctor right away if you have any serious side||
2347|055|S|effects, including: signs of infection (such as sore throat that||
2347|056|S|doesn't go away, fever, chills), easy bruising/bleeding.||
2347|057|S|   A very serious allergic reaction to this drug is rare.||
2347|058|S|However, get medical help right away if you notice any symptoms||
2347|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2347|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2347|061|S|breathing.||
2347|062|S|   This is not a complete list of possible side effects. If you||
2347|063|S|notice any other effects not listed above, contact your doctor or||
2347|064|S|pharmacist.||
2347|065|S|   In the US -||
2347|066|S|   Call your doctor for medical advice about side effects. You||
2347|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2347|068|S|www.fda.gov/medwatch.||
2347|069|S|   In Canada - Call your doctor for medical advice about side||
2347|070|S|effects. You may report side effects to Health Canada at||
2347|071|S|1-866-234-2345.||
2347|072|B|||
2347|073|P|PRECAUTIONS:  Before taking belumosudil, tell your doctor or||
2347|074|P|pharmacist if you are allergic to it; or if you have any other||
2347|075|P|allergies. This product may contain inactive ingredients, which||
2347|076|P|can cause allergic reactions or other problems. Talk to your||
2347|077|P|pharmacist for more details.||
2347|078|P|   Before using this medication, tell your doctor or pharmacist||
2347|079|P|your medical history, especially of: liver disease.||
2347|080|P|   Before having surgery, tell your doctor or dentist about all||
2347|081|P|the products you use (including prescription drugs,||
2347|082|P|nonprescription drugs, and herbal products).||
2347|083|P|   Tell your doctor if you are pregnant or plan to become||
2347|084|P|pregnant. You should not become pregnant while using belumosudil.||
2347|085|P|Belumosudil may harm an unborn baby. Your doctor should order a||
2347|086|P|pregnancy test before you start this medication. Women using this||
2347|087|P|medication should ask about reliable forms of birth control||
2347|088|P|during treatment and for 1 week after the last dose. Men using||
2347|089|P|this medication should ask about reliable forms of birth control||
2347|090|P|during treatment and for some time after the last dose. If you or||
2347|091|P|your partner becomes pregnant, talk to your doctor right away||
2347|092|P|about the risks and benefits of this medication.||
2347|093|P|   It is unknown if this drug passes into breast milk. Because of||
2347|094|P|the possible risk to the infant, breastfeeding is not recommended||
2347|095|P|while using this drug and for 1 week after the last dose. Consult||
2347|096|P|your doctor before breastfeeding.||
2347|097|B|||
2347|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2347|099|I|medications work or increase your risk for serious side effects.||
2347|100|I|This document does not contain all possible drug interactions.||
2347|101|I|Keep a list of all the products you use (including||
2347|102|I|prescription/nonprescription drugs and herbal products) and share||
2347|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
2347|104|I|the dosage of any medicines without your doctor's approval.||
2347|105|I|   This medication can slow down the removal of other medications||
2347|106|I|from your body, which may affect how they work. Examples of||
2347|107|I|affected drugs include elagolix, elbasvir/grazoprevir,||
2347|108|I|irinotecan, among others.||
2347|109|B|||
2347|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2347|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2347|112|O|poison control center right away. US residents can call||
2347|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2347|114|B|||
2347|115|N|NOTES:  Do not share this medication with others.||
2347|116|N|   Lab and/or medical tests (such as complete blood count,||
2347|117|N|liver/kidney function, blood pressure, blood mineral levels)||
2347|118|N|should be done while you are taking this medication. Keep all||
2347|119|N|medical and lab appointments. Consult your doctor for more||
2347|120|N|details.||
2347|121|B|||
2347|122|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2347|123|D|remember. If you don't remember until the next day, skip the||
2347|124|D|missed dose. Take your next dose at the regular time. Do not||
2347|125|D|double the dose to catch up.||
2347|126|B|||
2347|127|R|STORAGE:  Store in the original container at room temperature||
2347|128|R|away from light and moisture. Do not store in the bathroom. Keep||
2347|129|R|the drying agent (desiccant) in the bottle. Tightly close the||
2347|130|R|bottle when not in use. Keep all medications away from children||
2347|131|R|and pets.||
2347|132|R|   Do not flush medications down the toilet or pour them into a||
2347|133|R|drain unless instructed to do so. Properly discard this product||
2347|134|R|when it is expired or no longer needed. Consult your pharmacist||
2347|135|R|or local waste disposal company.||
2347|136|B|||
2347|137|A|Information last revised July 2024.||
2347|138|A|Copyright(c) 2025 First Databank, Inc.||
2347|139|B|||
2348|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2348|002|Z|does NOT have all possible information about this product. This||
2348|003|Z|information does not assure that this product is safe, effective,||
2348|004|Z|or appropriate for you. This information is not individual||
2348|005|Z|medical advice and does not substitute for the advice of your||
2348|006|Z|health care professional. Always ask your health care||
2348|007|Z|professional for complete information about this product and your||
2348|008|Z|specific health needs.||
2348|009|B|||
2348|010|T|ODEVIXIBAT - ORAL||
2348|011|F|(OH-de-VIX-i-bat)||
2348|012|B|||
2348|013|C|COMMON BRAND NAME(S): Bylvay||
2348|014|B|||
2348|015|U|USES:  Depending on your brand, this medication is used to treat||
2348|016|U|skin itching caused by certain inherited liver conditions||
2348|017|U|(progressive familial intrahepatic cholestasis-PFIC or Alagille||
2348|018|U|syndrome-ALGS). In PFIC and ALGS, a substance that your body||
2348|019|U|normally makes (bilirubin) builds up in the liver and results in||
2348|020|U|jaundice. Odevixibat belongs to a class of drugs known as ileal||
2348|021|U|bile acid transporter inhibitors. It helps to lessen symptoms of||
2348|022|U|jaundice such as itching, yellowing eyes/skin, dark urine, and||
2348|023|U|pale colored stools.||
2348|024|B|||
2348|025|H|HOW TO USE:  Read the Instructions for Use leaflet if available||
2348|026|H|from your pharmacist before you start using odevixibat and each||
2348|027|H|time you get a refill. If you have any questions, ask your doctor||
2348|028|H|or pharmacist.||
2348|029|H|   Take this medication by mouth with food as directed by your||
2348|030|H|doctor, usually once daily with the morning meal. This medication||
2348|031|H|comes in 2 dosage forms: a capsule to swallow or a capsule that||
2348|032|H|contains pellets to sprinkle on food or liquid.||
2348|033|H|   If you are using the capsules that contain pellets, you must||
2348|034|H|open the capsules and sprinkle the pellets onto soft food or||
2348|035|H|liquid as directed. Do not swallow these capsules whole. For||
2348|036|H|mixing in soft food, place up to 2 tablespoonsful (30||
2348|037|H|milliliters) of soft food in a container. Keep food at or below||
2348|038|H|room temperature. Some recommended soft foods include: apple||
2348|039|H|sauce, oatmeal, banana or carrot puree, or chocolate or rice||
2348|040|H|pudding. Gently mix the prescribed dose in the soft food (the||
2348|041|H|pellets will not dissolve) and give all of the dose right away.||
2348|042|H|Do not store the mixture for later use. Drink some liquid after||
2348|043|H|the dose is taken. For mixing in liquid (such as water, breast||
2348|044|H|milk, formula), empty the pellets in a mixing cup. Place 1||
2348|045|H|teaspoonful (5 milliliters) of liquid into the cup and let the||
2348|046|H|pellets sit in the liquid for about 5 minutes (the pellets will||
2348|047|H|not dissolve). Follow instructions on how to mix and give the||
2348|048|H|liquid mixture using the oral syringe. Drink some liquid after||
2348|049|H|the dose is taken. Throw away the empty capsule shell(s) in the||
2348|050|H|trash.||
2348|051|H|   If you are using the capsules to swallow, swallow the||
2348|052|H|capsule(s) with a glass of water. Do not chew or crush the||
2348|053|H|capsules. If you have trouble swallowing the capsule(s), you may||
2348|054|H|open the capsule and sprinkle the contents onto soft food or||
2348|055|H|liquid as directed, using the same instructions as the capsules||
2348|056|H|that contain pellets.||
2348|057|H|   The dosage is based on your medical condition, weight, and||
2348|058|H|response to treatment. Use this medication regularly to get the||
2348|059|H|most benefit from it. To help you remember, take it at the same||
2348|060|H|time each day.||
2348|061|H|   If you are also taking bile acid-binding resins such as||
2348|062|H|cholestyramine, colesevelam, or colestipol, take this medication||
2348|063|H|at least 4 hours before or at least 4 hours after taking these||
2348|064|H|medications. These medications can bind to odevixibat, preventing||
2348|065|H|your body from fully absorbing the drug.||
2348|066|H|   Tell your doctor if your condition does not get better or if||
2348|067|H|it gets worse.||
2348|068|B|||
2348|069|S|SIDE EFFECTS:  Diarrhea, abdominal pain, or vomiting may occur.||
2348|070|S|If any of these effects last or get worse, tell your doctor or||
2348|071|S|pharmacist promptly.||
2348|072|S|   Remember that this medication has been prescribed because your||
2348|073|S|doctor has judged that the benefit to you is greater than the||
2348|074|S|risk of side effects. Many people using this medication do not||
2348|075|S|have serious side effects.||
2348|076|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2348|077|S|Contact your doctor promptly if you notice any symptoms of||
2348|078|S|dehydration, such as unusual decreased urination, unusual dry||
2348|079|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness.||
2348|080|S|   Tell your doctor right away if you have any serious side||
2348|081|S|effects, including: easy bleeding/bruising.||
2348|082|S|   Although this medication is used to treat liver problems, it||
2348|083|S|may sometimes cause other serious liver problems. Tell your||
2348|084|S|doctor right away if you have new or worsening symptoms of liver||
2348|085|S|problems such as nausea/vomiting that doesn't stop, loss of||
2348|086|S|appetite, stomach/abdominal pain, yellowing eyes/skin, or dark||
2348|087|S|urine.||
2348|088|S|   A very serious allergic reaction to this drug is rare.||
2348|089|S|However, get medical help right away if you notice any symptoms||
2348|090|S|of a serious allergic reaction, including: rash, itching/swelling||
2348|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2348|092|S|breathing.||
2348|093|S|   This is not a complete list of possible side effects. If you||
2348|094|S|notice other effects not listed above, contact your doctor or||
2348|095|S|pharmacist.||
2348|096|S|   In the US -||
2348|097|S|   Call your doctor for medical advice about side effects. You||
2348|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2348|099|S|www.fda.gov/medwatch.||
2348|100|S|   In Canada - Call your doctor for medical advice about side||
2348|101|S|effects. You may report side effects to Health Canada at||
2348|102|S|1-866-234-2345.||
2348|103|B|||
2348|104|P|PRECAUTIONS:  Before taking odevixibat, tell your doctor or||
2348|105|P|pharmacist if you are allergic to it; or if you have any other||
2348|106|P|allergies. This product may contain inactive ingredients, which||
2348|107|P|can cause allergic reactions or other problems. Talk to your||
2348|108|P|pharmacist for more details.||
2348|109|P|   Before using this medication, tell your doctor or pharmacist||
2348|110|P|your medical history, especially of: other liver problems (such||
2348|111|P|as ascites, encephalopathy, variceal bleeding).||
2348|112|P|   Before having surgery, tell your doctor or dentist about all||
2348|113|P|the products you use (including prescription drugs,||
2348|114|P|nonprescription drugs, and herbal products).||
2348|115|P|   Tell your doctor if you are pregnant or plan to become||
2348|116|P|pregnant. You should not become pregnant while using odevixibat.||
2348|117|P|Odevixibat may harm an unborn baby. If you become pregnant, talk||
2348|118|P|to your doctor right away about the risks and benefits of this||
2348|119|P|medication.||
2348|120|P|   It is unknown if this medication passes into breast milk.||
2348|121|P|Consult your doctor before breastfeeding.||
2348|122|B|||
2348|123|I|DRUG INTERACTIONS:  See also How to Use section.||
2348|124|I|   Drug interactions may change how your medications work or||
2348|125|I|increase your risk for serious side effects. This document does||
2348|126|I|not contain all possible drug interactions. Keep a list of all||
2348|127|I|the products you use (including prescription/nonprescription||
2348|128|I|drugs and herbal products) and share it with your doctor and||
2348|129|I|pharmacist. Do not start, stop, or change the dosage of any||
2348|130|I|medicines without your doctor's approval.||
2348|131|B|||
2348|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2348|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2348|134|O|poison control center right away. US residents can call||
2348|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2348|136|B|||
2348|137|N|NOTES:  Do not share this medication with others.||
2348|138|N|   Lab and/or medical tests (such as liver function, fat-soluble||
2348|139|N|vitamin levels) should be done before starting this medication||
2348|140|N|and while you are taking it. Keep all medical and lab||
2348|141|N|appointments.||
2348|142|B|||
2348|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2348|144|D|remember. If it is near the time of the next dose, skip the||
2348|145|D|missed dose. Take your next dose at the regular time. Do not||
2348|146|D|double the dose to catch up.||
2348|147|B|||
2348|148|R|STORAGE:  Store at room temperature away from light and moisture.||
2348|149|R|Do not store in the bathroom. Keep all medications away from||
2348|150|R|children and pets.||
2348|151|R|   Do not flush medications down the toilet or pour them into a||
2348|152|R|drain unless instructed to do so. Properly discard this product||
2348|153|R|when it is expired or no longer needed. Consult your pharmacist||
2348|154|R|or local waste disposal company.||
2348|155|B|||
2348|156|A|Information last revised March 2025.||
2348|157|A|Copyright(c) 2025 First Databank, Inc.||
2348|158|B|||
2349|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2349|002|Z|does NOT have all possible information about this product. This||
2349|003|Z|information does not assure that this product is safe, effective,||
2349|004|Z|or appropriate for you. This information is not individual||
2349|005|Z|medical advice and does not substitute for the advice of your||
2349|006|Z|health care professional. Always ask your health care||
2349|007|Z|professional for complete information about this product and your||
2349|008|Z|specific health needs.||
2349|009|B|||
2349|010|T|MIRABEGRON EXTENDED-RELEASE SUSPENSION - ORAL||
2349|011|F|(MIR-a-BEG-ron)||
2349|012|B|||
2349|013|C|COMMON BRAND NAME(S): Myrbetriq||
2349|014|B|||
2349|015|U|USES:  This medication is used to treat a certain bladder problem||
2349|016|U|(neurogenic detrusor overactivity-NDO). NDO is a bladder control||
2349|017|U|condition caused by brain, spinal cord, or nerve problems.||
2349|018|U|Symptoms may include frequent urination, strong sudden urges to||
2349|019|U|urinate, or involuntary loss of urine (incontinence). Mirabegron||
2349|020|U|works by relaxing a certain bladder muscle (detrusor), which||
2349|021|U|helps the bladder hold more urine and lessens symptoms of NDO.||
2349|022|B|||
2349|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2349|024|H|from your pharmacist before you start taking mirabegron and each||
2349|025|H|time you get a refill. If you have any questions, ask your doctor||
2349|026|H|or pharmacist.||
2349|027|H|   Take this medication by mouth with food as directed by your||
2349|028|H|doctor, usually once daily. You will receive this medication from||
2349|029|H|the pharmacy as a suspension that has been prepared by your||
2349|030|H|pharmacist. Shake the bottle well for 1 minute before use. Then||
2349|031|H|let it stand until the foam on top of the suspension is gone||
2349|032|H|(about 1 to 2 minutes). If the granules have not mixed well,||
2349|033|H|shake the bottle well again for 1 minute and let it stand until||
2349|034|H|the foam is gone. Carefully measure the dose using a special||
2349|035|H|measuring device/spoon. Disregard any bubbles when measuring. Do||
2349|036|H|not use a household spoon because you may not get the correct||
2349|037|H|dose. Take within 1 hour after you have measured out the dose.||
2349|038|H|Wash the special measuring device/spoon after each use and let it||
2349|039|H|air dry.||
2349|040|H|   If the suspension will not be used for 2 or more days, shake||
2349|041|H|the bottle well for 1 minute each day.||
2349|042|H|   The dosage is based on your medical condition, weight, and||
2349|043|H|response to treatment.||
2349|044|H|   Use this medication regularly to get the most benefit from it.||
2349|045|H|To help you remember, take it at the same time each day.||
2349|046|H|   Tell your doctor if your condition does not get better or if||
2349|047|H|it gets worse.||
2349|048|B|||
2349|049|S|SIDE EFFECTS:  Constipation, pain/swelling of the nose or throat,||
2349|050|S|or headache may occur. If any of these effects last or get worse,||
2349|051|S|tell your doctor or pharmacist promptly.||
2349|052|S|   Remember that this medication has been prescribed because your||
2349|053|S|doctor has judged that the benefit to you is greater than the||
2349|054|S|risk of side effects. Many people using this medication do not||
2349|055|S|have serious side effects.||
2349|056|S|   This medication may raise your blood pressure. Check your||
2349|057|S|blood pressure regularly and tell your doctor if the results are||
2349|058|S|high.||
2349|059|S|   Tell your doctor right away if you have any serious side||
2349|060|S|effects, including: burning/painful urination.||
2349|061|S|   A very serious allergic reaction to this drug is rare.||
2349|062|S|However, get medical help right away if you notice any symptoms||
2349|063|S|of a serious allergic reaction, including: rash, itching/swelling||
2349|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2349|065|S|breathing.||
2349|066|S|   This is not a complete list of possible side effects. If you||
2349|067|S|notice other effects not listed above, contact your doctor or||
2349|068|S|pharmacist.||
2349|069|S|   In the US -||
2349|070|S|   Call your doctor for medical advice about side effects. You||
2349|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2349|072|S|www.fda.gov/medwatch.||
2349|073|S|   In Canada - Call your doctor for medical advice about side||
2349|074|S|effects. You may report side effects to Health Canada at||
2349|075|S|1-866-234-2345.||
2349|076|B|||
2349|077|P|PRECAUTIONS:  Before taking mirabegron, tell your doctor or||
2349|078|P|pharmacist if you are allergic to it; or if you have any other||
2349|079|P|allergies. This product may contain inactive ingredients, which||
2349|080|P|can cause allergic reactions or other problems. Talk to your||
2349|081|P|pharmacist for more details.||
2349|082|P|   Before using this medication, tell your doctor or pharmacist||
2349|083|P|your medical history, especially of: other bladder problems (such||
2349|084|P|as blockage), high blood pressure, kidney problems, liver||
2349|085|P|problems.||
2349|086|P|   Before having surgery, tell your doctor or dentist about all||
2349|087|P|the products you use (including prescription drugs,||
2349|088|P|nonprescription drugs, and herbal products).||
2349|089|P|   During pregnancy, this medication should be used only when||
2349|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
2349|091|P|   It is unknown if this medication passes into breast milk.||
2349|092|P|Consult your doctor before breastfeeding.||
2349|093|B|||
2349|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2349|095|I|medications work or increase your risk for serious side effects.||
2349|096|I|This document does not contain all possible drug interactions.||
2349|097|I|Keep a list of all the products you use (including||
2349|098|I|prescription/nonprescription drugs and herbal products) and share||
2349|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2349|100|I|the dosage of any medicines without your doctor's approval.||
2349|101|I|   This medication can slow down the removal of other medications||
2349|102|I|from your body, which may affect how they work. Examples of||
2349|103|I|affected drugs include flecainide, propafenone, thioridazine,||
2349|104|I|among others.||
2349|105|B|||
2349|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2349|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2349|108|O|poison control center right away. US residents can call||
2349|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2349|110|B|||
2349|111|N|NOTES:  Do not share this medication with others.||
2349|112|N|   Lab and/or medical tests (such as blood pressure) may be done||
2349|113|N|while you are taking this medication. Keep all medical and lab||
2349|114|N|appointments.||
2349|115|B|||
2349|116|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2349|117|D|remember. If it is more than 12 hours after the missed dose, skip||
2349|118|D|the missed dose. Take your next dose at the regular time. Do not||
2349|119|D|double the dose to catch up.||
2349|120|B|||
2349|121|R|STORAGE:  Store at room temperature. Discard any unused portion||
2349|122|R|after 28 days. Keep all medications away from children and pets.||
2349|123|R|   Do not flush medications down the toilet or pour them into a||
2349|124|R|drain unless instructed to do so. Properly discard this product||
2349|125|R|when it is expired or no longer needed. Consult your pharmacist||
2349|126|R|or local waste disposal company.||
2349|127|B|||
2349|128|A|Information last revised October 2024.||
2349|129|A|Copyright(c) 2025 First Databank, Inc.||
2349|130|B|||
2350|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2350|002|Z|does NOT have all possible information about this product. This||
2350|003|Z|information does not assure that this product is safe, effective,||
2350|004|Z|or appropriate for you. This information is not individual||
2350|005|Z|medical advice and does not substitute for the advice of your||
2350|006|Z|health care professional. Always ask your health care||
2350|007|Z|professional for complete information about this product and your||
2350|008|Z|specific health needs.||
2350|009|B|||
2350|010|T|ANIFROLUMAB - INJECTION||
2350|011|F|(AN-i-FROL-ue-mab)||
2350|012|B|||
2350|013|C|COMMON BRAND NAME(S): Saphnelo||
2350|014|B|||
2350|015|U|USES:  This medication is used to treat a certain immune system||
2350|016|U|problem (lupus). Anifrolumab belongs to a class of drugs known as||
2350|017|U|monoclonal antibodies.||
2350|018|B|||
2350|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2350|020|H|from your pharmacist before you start using anifrolumab and each||
2350|021|H|time you receive an injection. If you have any questions, ask||
2350|022|H|your doctor or pharmacist.||
2350|023|H|   This medication is given by injection into a vein by a health||
2350|024|H|care professional. It is given as directed by your doctor,||
2350|025|H|usually once every 4 weeks. It is infused over 30 minutes.||
2350|026|H|   Use this medication regularly to get the most benefit from it.||
2350|027|H|To help you remember, mark your calendar with a reminder.||
2350|028|B|||
2350|029|S|SIDE EFFECTS:  Headache, nausea, vomiting, dizziness, or||
2350|030|S|tiredness may occur while you are receiving the drug. If any of||
2350|031|S|these effects last or get worse, tell your doctor or pharmacist||
2350|032|S|promptly.||
2350|033|S|   Remember that this medication has been prescribed because your||
2350|034|S|doctor has judged that the benefit to you is greater than the||
2350|035|S|risk of side effects. Many people using this medication do not||
2350|036|S|have serious side effects.||
2350|037|S|   Tell your doctor right away if you have any serious side||
2350|038|S|effects, including: pain/numbness/tingling of the skin, skin||
2350|039|S|blisters.||
2350|040|S|   This medication may lower your ability to fight infections.||
2350|041|S|This may make you more likely to get a serious (rarely fatal)||
2350|042|S|infection or make any infection you have worse. Tell your doctor||
2350|043|S|right away if you have any signs of infection (such as sore||
2350|044|S|throat that doesn't go away, fever, chills, shortness of breath).||
2350|045|S|   Medications that affect the immune system (such as||
2350|046|S|anifrolumab) may rarely increase the risk of cancer. Talk to your||
2350|047|S|doctor for more details.||
2350|048|S|   A very serious allergic reaction to this drug is rare.||
2350|049|S|However, get medical help right away if you notice any symptoms||
2350|050|S|of a serious allergic reaction, including: rash, itching/swelling||
2350|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2350|052|S|breathing.||
2350|053|S|   This is not a complete list of possible side effects. If you||
2350|054|S|notice other effects not listed above, contact your doctor or||
2350|055|S|pharmacist.||
2350|056|S|   In the US -||
2350|057|S|   Call your doctor for medical advice about side effects. You||
2350|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2350|059|S|www.fda.gov/medwatch.||
2350|060|S|   In Canada - Call your doctor for medical advice about side||
2350|061|S|effects. You may report side effects to Health Canada at||
2350|062|S|1-866-234-2345.||
2350|063|B|||
2350|064|P|PRECAUTIONS:  Before using anifrolumab, tell your doctor or||
2350|065|P|pharmacist if you are allergic to it; or if you have any other||
2350|066|P|allergies. This product may contain inactive ingredients, which||
2350|067|P|can cause allergic reactions or other problems. Talk to your||
2350|068|P|pharmacist for more details.||
2350|069|P|   Before using this medication, tell your doctor or pharmacist||
2350|070|P|your medical history, especially of: cancer,||
2350|071|P|current/recent/returning infection (such as herpes zoster).||
2350|072|P|   Anifrolumab can make you more likely to get infections or may||
2350|073|P|make current infections worse. Stay away from anyone who has an||
2350|074|P|infection that may easily spread (such as chickenpox, COVID-19,||
2350|075|P|measles, flu). Talk to your doctor if you have been exposed to an||
2350|076|P|infection or for more details.||
2350|077|P|   Tell your health care professional that you are using||
2350|078|P|anifrolumab before having any immunizations/vaccinations. Avoid||
2350|079|P|contact with people who have recently received live vaccines||
2350|080|P|(such as flu vaccine inhaled through the nose).||
2350|081|P|   Before having surgery, tell your doctor or dentist about all||
2350|082|P|the products you use (including prescription drugs,||
2350|083|P|nonprescription drugs, and herbal products).||
2350|084|P|   During pregnancy, this medication should be used only when||
2350|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
2350|086|P|   It is unknown if this medication passes into breast milk.||
2350|087|P|Consult your doctor before breastfeeding.||
2350|088|B|||
2350|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2350|090|I|medications work or increase your risk for serious side effects.||
2350|091|I|This document does not contain all possible drug interactions.||
2350|092|I|Keep a list of all the products you use (including||
2350|093|I|prescription/nonprescription drugs and herbal products) and share||
2350|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
2350|095|I|the dosage of any medicines without your doctor's approval.||
2350|096|B|||
2350|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2350|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2350|099|O|poison control center right away. US residents can call||
2350|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2350|101|B|||
2350|102|N|NOTES:  Keep all medical and lab appointments.||
2350|103|B|||
2350|104|D|MISSED DOSE:  It is important to get each dose of this medication||
2350|105|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2350|106|D|right away for a new dosing schedule.||
2350|107|B|||
2350|108|R|STORAGE:  Not applicable. This medication is given in a hospital||
2350|109|R|or clinic and will not be stored at home.||
2350|110|B|||
2350|111|M|MEDICAL ALERT:  Your condition can cause complications in a||
2350|112|M|medical emergency. For information about enrolling in MedicAlert,||
2350|113|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2350|114|B|||
2350|115|A|Information last revised April 2025.||
2350|116|A|Copyright(c) 2025 First Databank, Inc.||
2350|117|B|||
2351|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2351|002|Z|does NOT have all possible information about this product. This||
2351|003|Z|information does not assure that this product is safe, effective,||
2351|004|Z|or appropriate for you. This information is not individual||
2351|005|Z|medical advice and does not substitute for the advice of your||
2351|006|Z|health care professional. Always ask your health care||
2351|007|Z|professional for complete information about this product and your||
2351|008|Z|specific health needs.||
2351|009|B|||
2351|010|T|SELEXIPAG - INJECTION||
2351|011|F|(se-LEX-i-pag)||
2351|012|B|||
2351|013|C|COMMON BRAND NAME(S): Uptravi||
2351|014|B|||
2351|015|U|USES:  Selexipag is used to treat high blood pressure in the||
2351|016|U|lungs (pulmonary arterial hypertension-PAH). It is used to help||
2351|017|U|slow down worsening of PAH and to decrease the chance of needing||
2351|018|U|treatment in a hospital. Selexipag works by making it easier for||
2351|019|U|blood to flow through the arteries in your lungs. This effect||
2351|020|U|helps increase your ability to exercise.||
2351|021|B|||
2351|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2351|023|H|from your pharmacist before you start using selexipag and each||
2351|024|H|time you receive an injection. If you have any questions, ask||
2351|025|H|your doctor or pharmacist.||
2351|026|H|   This medication is given by injection into a vein by a health||
2351|027|H|care professional. It is given as directed by your doctor,||
2351|028|H|usually twice daily. It is infused over 80 minutes.||
2351|029|H|   The dosage is based on your medical condition, response to||
2351|030|H|treatment, and other medications you may be taking. Be sure to||
2351|031|H|tell your doctor and pharmacist about all the products you use||
2351|032|H|(including prescription drugs, nonprescription drugs, and herbal||
2351|033|H|products). To reduce your risk of side effects, your doctor may||
2351|034|H|direct you to start this medication at a low dose and gradually||
2351|035|H|increase your dose. Follow your doctor's instructions carefully.||
2351|036|H|   Use this medication regularly to get the most benefit from it.||
2351|037|H|To help you remember, use it at the same times each day.||
2351|038|H|   Tell your doctor if your condition does not get better or if||
2351|039|H|it gets worse.||
2351|040|B|||
2351|041|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
2351|042|S|headache, nausea, vomiting, diarrhea, loss of appetite, flushing,||
2351|043|S|jaw pain, joint/muscle pain, or pain in your arms or legs may||
2351|044|S|occur. If any of these effects last or get worse, tell your||
2351|045|S|doctor or pharmacist promptly.||
2351|046|S|   Remember that this medication has been prescribed because your||
2351|047|S|doctor has judged that the benefit to you is greater than the||
2351|048|S|risk of side effects. Many people using this medication do not||
2351|049|S|have serious side effects.||
2351|050|S|   A very serious allergic reaction to this drug is rare.||
2351|051|S|However, get medical help right away if you notice any symptoms||
2351|052|S|of a serious allergic reaction, including: rash, itching/swelling||
2351|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2351|054|S|breathing.||
2351|055|S|   This is not a complete list of possible side effects. If you||
2351|056|S|notice other effects not listed above, contact your doctor or||
2351|057|S|pharmacist.||
2351|058|S|   In the US -||
2351|059|S|   Call your doctor for medical advice about side effects. You||
2351|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2351|061|S|www.fda.gov/medwatch.||
2351|062|S|   In Canada - Call your doctor for medical advice about side||
2351|063|S|effects. You may report side effects to Health Canada at||
2351|064|S|1-866-234-2345.||
2351|065|B|||
2351|066|P|PRECAUTIONS:  Before using selexipag, tell your doctor or||
2351|067|P|pharmacist if you are allergic to it; or if you have any other||
2351|068|P|allergies. This product may contain inactive ingredients, which||
2351|069|P|can cause allergic reactions or other problems. Talk to your||
2351|070|P|pharmacist for more details.||
2351|071|P|   Before using this medication, tell your doctor or pharmacist||
2351|072|P|your medical history, especially of: liver disease.||
2351|073|P|   Before having surgery, tell your doctor or dentist about all||
2351|074|P|the products you use (including prescription drugs,||
2351|075|P|nonprescription drugs, and herbal products).||
2351|076|P|   During pregnancy, this medication should be used only when||
2351|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
2351|078|P|   It is unknown if this drug passes into breast milk. Consult||
2351|079|P|your doctor before breastfeeding.||
2351|080|B|||
2351|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2351|082|I|medications work or increase your risk for serious side effects.||
2351|083|I|This document does not contain all possible drug interactions.||
2351|084|I|Keep a list of all the products you use (including||
2351|085|I|prescription/nonprescription drugs and herbal products) and share||
2351|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
2351|087|I|the dosage of any medicines without your doctor's approval.||
2351|088|I|   Other medications can affect the removal of selexipag from||
2351|089|I|your body, which may affect how selexipag works. An example is||
2351|090|I|gemfibrozil.||
2351|091|B|||
2351|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2351|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2351|094|O|poison control center right away. US residents can call||
2351|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2351|096|B|||
2351|097|N|NOTES:  Keep all medical and lab appointments.||
2351|098|B|||
2351|099|D|MISSED DOSE:  It is important to get each dose of this medication||
2351|100|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2351|101|D|right away for a new dosing schedule.||
2351|102|B|||
2351|103|R|STORAGE:  Not applicable. This medication is given in a hospital||
2351|104|R|or clinic and will not be stored at home.||
2351|105|B|||
2351|106|A|Information last revised February 2025.||
2351|107|A|Copyright(c) 2025 First Databank, Inc.||
2351|108|B|||
2353|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2353|002|Z|does NOT have all possible information about this product. This||
2353|003|Z|information does not assure that this product is safe, effective,||
2353|004|Z|or appropriate for you. This information is not individual||
2353|005|Z|medical advice and does not substitute for the advice of your||
2353|006|Z|health care professional. Always ask your health care||
2353|007|Z|professional for complete information about this product and your||
2353|008|Z|specific health needs.||
2353|009|B|||
2353|010|T|RIVAROXABAN SUSPENSION - ORAL||
2353|011|F|(RIV-a-ROX-a-ban)||
2353|012|B|||
2353|013|C|COMMON BRAND NAME(S): Xarelto||
2353|014|B|||
2353|015|W|WARNING:  Do not stop taking rivaroxaban unless directed by your||
2353|016|W|doctor. If you stop taking this medication early, you have a||
2353|017|W|higher risk of forming a serious blood clot (such as a stroke,||
2353|018|W|blood clot in the legs/lungs). Your doctor may direct you to take||
2353|019|W|a different "blood thinning" or antiplatelet medication to reduce||
2353|020|W|your risk. Get medical help right away if you have weakness on||
2353|021|W|one side of the body, trouble speaking, sudden vision changes,||
2353|022|W|confusion, chest pain, trouble breathing, or pain/warmth/swelling||
2353|023|W|in the legs.||
2353|024|W|   People taking this medication may bleed near the spinal cord||
2353|025|W|after certain spinal procedures. Bleeding in this area can cause||
2353|026|W|paralysis that lasts a long time or could become permanent.||
2353|027|W|Before any spinal procedure, ask your doctor about the benefits||
2353|028|W|and risks. The risk of bleeding may be higher if you have a||
2353|029|W|deformed spine, or have had spinal procedures/surgery before||
2353|030|W|(such as epidural catheter placement, difficult epidural/spinal||
2353|031|W|puncture), or are taking other drugs that can cause||
2353|032|W|bleeding/bruising (including antiplatelet drugs such as||
2353|033|W|clopidogrel, "blood thinners" such as warfarin/enoxaparin,||
2353|034|W|nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen).||
2353|035|W|Tell your doctor right away if you notice symptoms such as back||
2353|036|W|pain, leg numbness/tingling/weakness, loss of control of the||
2353|037|W|bowels or bladder (incontinence).||
2353|038|B|||
2353|039|U|USES:  Rivaroxaban suspension is used to treat blood clots (such||
2353|040|U|as in deep vein thrombosis-DVT or pulmonary embolus-PE) and to||
2353|041|U|prevent the blood clots from forming again. It may also be used||
2353|042|U|to prevent blood clots from forming after a certain heart surgery||
2353|043|U|(Fontan procedure).||
2353|044|U|   Rivaroxaban is an anticoagulant that works by blocking certain||
2353|045|U|clotting proteins in your blood.||
2353|046|B|||
2353|047|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2353|048|H|provided by your pharmacist before you start using rivaroxaban||
2353|049|H|suspension and each time you get a refill. If you have any||
2353|050|H|questions, ask your doctor or pharmacist.||
2353|051|H|   Some brands of this medication are prepared by a health care||
2353|052|H|professional, while other brands may give you instructions for||
2353|053|H|how to prepare the suspension before use. Carefully read and||
2353|054|H|follow the manufacturer's directions for your brand of||
2353|055|H|rivaroxaban suspension.||
2353|056|H|   Take this medication by mouth as directed by your doctor,||
2353|057|H|usually 1 to 3 times a day. Follow your doctor's directions for||
2353|058|H|taking this medication with or without food. If your brand of||
2353|059|H|medication is stored in the refrigerator, allow the suspension to||
2353|060|H|come to room temperature before giving each dose. Do not warm up||
2353|061|H|this medication any other way such as by heating in the microwave||
2353|062|H|or placing the bottle in hot water. Shake the bottle well for at||
2353|063|H|least 10 seconds before each dose. Carefully measure the dose||
2353|064|H|using a special measuring device/spoon. Do not use a household||
2353|065|H|spoon because you may not get the correct dose. After each dose,||
2353|066|H|drink/give some liquid to make sure all of the dose is taken.||
2353|067|H|   If you or the child spits up or vomits less than 30 minutes||
2353|068|H|after taking the dose, take or give another dose. If this happens||
2353|069|H|more than 30 minutes after the dose, do not take or give a new||
2353|070|H|dose. Take/give the next dose at the usual time.||
2353|071|H|   If you are giving this medication through a tube into the||
2353|072|H|stomach (nasogastric or gastric tube), ask your health care||
2353|073|H|professional for detailed instructions on how to properly mix and||
2353|074|H|give it.||
2353|075|H|   Do not increase your dose, take it more often, or stop taking||
2353|076|H|it unless you are told to do so by your doctor.||
2353|077|H|   The dosage and length of treatment are based on your medical||
2353|078|H|condition, weight, and response to treatment.||
2353|079|H|   Use this medication regularly to get the most benefit from it.||
2353|080|H|To help you remember, take it at the same time(s) each day.||
2353|081|B|||
2353|082|S|SIDE EFFECTS:  See also Warning section.||
2353|083|S|   Easy bruising or minor bleeding (such as nosebleed, bleeding||
2353|084|S|from cuts) may occur. If either of these effects lasts or gets||
2353|085|S|worse, tell your doctor or pharmacist promptly.||
2353|086|S|   Remember that this medication has been prescribed because your||
2353|087|S|doctor has judged that the benefit to you is greater than the||
2353|088|S|risk of side effects. Many people using this medication do not||
2353|089|S|have serious side effects.||
2353|090|S|   This medication can cause serious bleeding if it affects your||
2353|091|S|blood clotting proteins too much. Tell your doctor right away if||
2353|092|S|you have any signs of serious bleeding, including: nosebleeds||
2353|093|S|that happen often or don't stop, unusual tiredness/weakness,||
2353|094|S|unusual pain/swelling/discomfort, unusual bruising, prolonged||
2353|095|S|bleeding from cuts or gums, unusually heavy/prolonged menstrual||
2353|096|S|flow, pink/dark urine, coughing up blood, vomit that is bloody or||
2353|097|S|looks like coffee grounds, severe headache, dizziness/fainting,||
2353|098|S|bloody/black/tarry stools, difficulty swallowing.||
2353|099|S|   Get medical help right away if you have any signs of very||
2353|100|S|serious bleeding, including: vision changes, confusion, trouble||
2353|101|S|speaking, weakness on one side of the body, injury to the spleen||
2353|102|S|(such as stomach/abdominal pain, shoulder pain).||
2353|103|S|   A very serious allergic reaction to this drug is rare.||
2353|104|S|However, get medical help right away if you notice any symptoms||
2353|105|S|of a serious allergic reaction, including: rash, itching/swelling||
2353|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2353|107|S|breathing.||
2353|108|S|   This is not a complete list of possible side effects. If you||
2353|109|S|notice other effects not listed above, contact your doctor or||
2353|110|S|pharmacist.||
2353|111|S|   In the US -||
2353|112|S|   Call your doctor for medical advice about side effects. You||
2353|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2353|114|S|www.fda.gov/medwatch.||
2353|115|S|   In Canada - Call your doctor for medical advice about side||
2353|116|S|effects. You may report side effects to Health Canada at||
2353|117|S|1-866-234-2345.||
2353|118|B|||
2353|119|P|PRECAUTIONS:  Before taking rivaroxaban, tell your doctor or||
2353|120|P|pharmacist if you are allergic to it; or if you have any other||
2353|121|P|allergies. This product may contain inactive ingredients, which||
2353|122|P|can cause allergic reactions or other problems. Talk to your||
2353|123|P|pharmacist for more details.||
2353|124|P|   Before using this medication, tell your doctor or pharmacist||
2353|125|P|your medical history, especially of: cancer, liver disease,||
2353|126|P|kidney disease, bleeding problems (such as bleeding of the||
2353|127|P|stomach/intestines, bleeding in the brain), stroke, artificial||
2353|128|P|heart valves, recent major injury/surgery, blood disorders (such||
2353|129|P|as anemia, hemophilia, thrombocytopenia), frequent||
2353|130|P|falls/injuries, a certain eye problem (retinopathy), a certain||
2353|131|P|clotting disorder (antiphospholipid syndrome), certain hereditary||
2353|132|P|enzyme problems (such as galactose intolerance, Lapp lactase||
2353|133|P|deficiency, glucose-galactose malabsorption).||
2353|134|P|   Before having surgery or any medical/dental procedures||
2353|135|P|(especially spinal puncture or spinal/epidural anesthesia), tell||
2353|136|P|your doctor or dentist that you are taking this medication and||
2353|137|P|about all the products you use (including prescription drugs,||
2353|138|P|nonprescription drugs, and herbal products). Your doctor or||
2353|139|P|dentist may tell you to stop taking rivaroxaban before your||
2353|140|P|surgery. Ask for specific instructions about stopping or starting||
2353|141|P|this medication.||
2353|142|P|   This medication may contain sugar or aspartame. Caution is||
2353|143|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
2353|144|P|condition that requires you to limit/avoid these substances in||
2353|145|P|your diet. Ask your doctor or pharmacist about using this product||
2353|146|P|safely.||
2353|147|P|   This medication may cause stomach bleeding. Daily use of||
2353|148|P|alcohol while using this medicine will increase your risk for||
2353|149|P|stomach bleeding. Limit alcoholic beverages. Ask your doctor or||
2353|150|P|pharmacist about how much alcohol you may safely drink.||
2353|151|P|   This medication can cause heavy bleeding. To lower the chance||
2353|152|P|of getting cut, bruised, or injured, use caution with sharp||
2353|153|P|objects like razors and nail cutters, and avoid activities such||
2353|154|P|as contact sports. Use an electric razor when shaving and a soft||
2353|155|P|toothbrush when brushing your teeth. If you fall or injure||
2353|156|P|yourself, especially if you hit your head, call your doctor right||
2353|157|P|away. Your doctor may need to check you.||
2353|158|P|   Older adults may be more sensitive to the side effects of this||
2353|159|P|drug, especially bleeding.||
2353|160|P|   During pregnancy, this medication should be used only when||
2353|161|P|clearly needed. Discuss the risks and benefits with your doctor.||
2353|162|P|   This medication may pass into breast milk. Consult your doctor||
2353|163|P|before breastfeeding.||
2353|164|B|||
2353|165|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2353|166|I|medications work or increase your risk for serious side effects.||
2353|167|I|This document does not contain all possible drug interactions.||
2353|168|I|Keep a list of all the products you use (including||
2353|169|I|prescription/nonprescription drugs and herbal products) and share||
2353|170|I|it with your doctor and pharmacist. Do not start, stop, or change||
2353|171|I|the dosage of any medicines without your doctor's approval.||
2353|172|I|   Some products that may interact with this drug are:||
2353|173|I|mifepristone, other drugs that can cause bleeding/bruising||
2353|174|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
2353|175|I|ibuprofen/naproxen, "blood thinners" such as||
2353|176|I|warfarin/enoxaparin), certain antidepressants (including SSRIs||
2353|177|I|such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine).||
2353|178|I|   Other medications can affect the removal of rivaroxaban from||
2353|179|I|your body, which may affect how rivaroxaban works. Examples||
2353|180|I|include cobicistat, dronedarone, ritonavir, certain azole||
2353|181|I|antifungals (itraconazole, ketoconazole, posaconazole), HIV||
2353|182|I|protease inhibitors (such as lopinavir), rifamycins (such as||
2353|183|I|rifampin), St. John's wort, drugs used to treat seizures (such as||
2353|184|I|carbamazepine, phenytoin, phenobarbital), among others.||
2353|185|I|   Aspirin can increase the risk of bleeding when used with this||
2353|186|I|medication. However, if your doctor has told you to take low-dose||
2353|187|I|aspirin to prevent heart attack or stroke (usually 81-162||
2353|188|I|milligrams a day), you should keep taking the aspirin unless your||
2353|189|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2353|190|I|details.||
2353|191|B|||
2353|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2353|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2353|194|O|poison control center right away. US residents can call||
2353|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2353|196|O|Symptoms of overdose may include: bloody/black/tarry stools,||
2353|197|O|pink/dark urine, unusual/prolonged bleeding.||
2353|198|B|||
2353|199|N|NOTES:  Do not share this medication with others.||
2353|200|N|   Lab and/or medical tests (such as hematocrit/hemoglobin, red||
2353|201|N|blood cell count) may be done while you are taking this||
2353|202|N|medication. Keep all medical and lab appointments.||
2353|203|B|||
2353|204|D|MISSED DOSE:  If you are taking this medication once a day and||
2353|205|D|miss a dose, take it as soon as you remember. If you don't||
2353|206|D|remember until the next day, skip the missed dose. Do not double||
2353|207|D|the dose to catch up.||
2353|208|D|   If you are taking this medication twice a day and miss a dose,||
2353|209|D|take it as soon as you remember. If you have missed the morning||
2353|210|D|dose and it is near the time of the evening dose, you may take||
2353|211|D|both doses together. If you miss the evening dose, take it as||
2353|212|D|soon as you remember only if you remember on the same evening.||
2353|213|D|   If you are taking this medication 3 times a day (about 8 hours||
2353|214|D|apart) and miss a dose, skip the missed dose. Take your next dose||
2353|215|D|at the regular time. Do not double the dose to catch up.||
2353|216|D|   On the following day, continue with the regular once, twice,||
2353|217|D|or three-times-daily schedule as directed by the doctor.||
2353|218|B|||
2353|219|R|STORAGE:  Different brands of this medication have different||
2353|220|R|storage needs. Check the product package for instructions on how||
2353|221|R|to store your brand, or ask your pharmacist. Keep all medications||
2353|222|R|away from children and pets.||
2353|223|R|   Do not flush medications down the toilet or pour them into a||
2353|224|R|drain unless instructed to do so. Properly discard this product||
2353|225|R|when it is expired or no longer needed. Consult your pharmacist||
2353|226|R|or local waste disposal company.||
2353|227|B|||
2353|228|M|MEDICAL ALERT:  Your condition can cause complications in a||
2353|229|M|medical emergency. For information about enrolling in MedicAlert,||
2353|230|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2353|231|B|||
2353|232|A|Information last revised June 2025.||
2353|233|A|Copyright(c) 2025 First Databank, Inc.||
2353|234|B|||
2354|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2354|002|Z|does NOT have all possible information about this product. This||
2354|003|Z|information does not assure that this product is safe, effective,||
2354|004|Z|or appropriate for you. This information is not individual||
2354|005|Z|medical advice and does not substitute for the advice of your||
2354|006|Z|health care professional. Always ask your health care||
2354|007|Z|professional for complete information about this product and your||
2354|008|Z|specific health needs.||
2354|009|B|||
2354|010|T|LORAZEPAM EXTENDED-RELEASE - ORAL||
2354|011|F|(lor-AZ-e-pam)||
2354|012|B|||
2354|013|C|COMMON BRAND NAME(S): Loreev XR||
2354|014|B|||
2354|015|W|WARNING:  Lorazepam has a risk for abuse and addiction, which can||
2354|016|W|lead to overdose and death. Taking this medication with alcohol||
2354|017|W|or other drugs that can cause drowsiness or breathing problems||
2354|018|W|(especially opioid medications such as codeine, hydrocodone) may||
2354|019|W|cause very serious side effects, including death. To lower your||
2354|020|W|risk, your doctor should have you take the smallest dose of||
2354|021|W|lorazepam that works, and take it for the shortest possible time.||
2354|022|W|Be sure you know how to take lorazepam and what other drugs you||
2354|023|W|should avoid taking with it. See also Drug Interactions section.||
2354|024|W|Get medical help right away if any of these very serious side||
2354|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
2354|026|W|severe drowsiness/dizziness, difficulty waking up.||
2354|027|W|   Suddenly stopping this medication may cause serious (possibly||
2354|028|W|fatal) withdrawal, especially if you have used it for a long time||
2354|029|W|or in high doses. To help prevent withdrawal, your doctor may||
2354|030|W|lower your dose slowly. Tell your doctor or pharmacist right away||
2354|031|W|if you have any withdrawal symptoms such as headaches, trouble||
2354|032|W|sleeping, restlessness, hallucinations/confusion, depression,||
2354|033|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
2354|034|W|to months.||
2354|035|B|||
2354|036|U|USES:  This form of lorazepam is used to treat anxiety in people||
2354|037|U|who are taking lorazepam in a stable, evenly divided dose||
2354|038|U|(usually 3 times a day). Lorazepam belongs to a class of drugs||
2354|039|U|known as benzodiazepines which act on the brain and nerves||
2354|040|U|(central nervous system) to produce a calming effect. This drug||
2354|041|U|works by enhancing the effects of a certain natural chemical in||
2354|042|U|the body (GABA).||
2354|043|B|||
2354|044|H|HOW TO USE:  See also Warning section.||
2354|045|H|   Read the Medication Guide provided by your pharmacist before||
2354|046|H|you start taking lorazepam and each time you get a refill. If you||
2354|047|H|have any questions, ask your doctor or pharmacist.||
2354|048|H|   Take this medication by mouth with or without food as directed||
2354|049|H|by your doctor, usually once daily in the morning. Swallow the||
2354|050|H|capsules whole. Do not crush or chew the capsules. Doing so can||
2354|051|H|release all of the drug at once, increasing the risk of side||
2354|052|H|effects. The dosage is based on your medical condition, age, and||
2354|053|H|response to treatment.||
2354|054|H|   If you have trouble swallowing the capsule whole, you may open||
2354|055|H|the capsule and sprinkle the contents on a tablespoon of||
2354|056|H|applesauce. Swallow all of the mixture right away without||
2354|057|H|chewing. After swallowing the mixture, drink some water to make||
2354|058|H|sure you have taken all your dose. The mixture should be used||
2354|059|H|within 2 hours. Do not store it for later use.||
2354|060|H|   Use this medication regularly to get the most benefit from it.||
2354|061|H|To help you remember, take it at the same time each day.||
2354|062|H|   Do not suddenly stop using this drug without consulting your||
2354|063|H|doctor. Some conditions may become worse when this drug is||
2354|064|H|suddenly stopped. Your doctor may lower your dose slowly.||
2354|065|H|   When this medication is used for a long time, it may not work||
2354|066|H|as well. Talk with your doctor if this medication stops working||
2354|067|H|well.||
2354|068|H|   Though it helps many people, this medication may sometimes||
2354|069|H|cause addiction. This risk may be higher if you have a substance||
2354|070|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2354|071|H|Take this medication exactly as prescribed to lower the risk of||
2354|072|H|addiction. Ask your doctor or pharmacist for more details.||
2354|073|H|   Tell your doctor if your condition does not get better or if||
2354|074|H|it gets worse.||
2354|075|B|||
2354|076|S|SIDE EFFECTS:  See also Warning section.||
2354|077|S|   Drowsiness, dizziness, loss of coordination, headache, nausea,||
2354|078|S|blurred vision, change in sexual interest/ability, constipation,||
2354|079|S|heartburn, or change in appetite may occur. If any of these||
2354|080|S|effects last or get worse, tell your doctor or pharmacist||
2354|081|S|promptly.||
2354|082|S|   Remember that this medication has been prescribed because your||
2354|083|S|doctor has judged that the benefit to you is greater than the||
2354|084|S|risk of side effects. Many people using this medication do not||
2354|085|S|have serious side effects.||
2354|086|S|   Tell your doctor right away if you have any serious side||
2354|087|S|effects, including: mental/mood changes (such as hallucinations,||
2354|088|S|depression, thoughts of suicide), trouble speaking, vision||
2354|089|S|changes, unusual weakness, trouble walking, memory problems,||
2354|090|S|signs of infection (such as sore throat that doesn't go away,||
2354|091|S|fever, chills).||
2354|092|S|   Get medical help right away if you have any very serious side||
2354|093|S|effects, including: seizures, slow/shallow breathing.||
2354|094|S|   This medication can rarely have the opposite of its usual||
2354|095|S|calming effect. Symptoms of this opposite effect may include||
2354|096|S|agitation, irritability, violent behavior, confusion,||
2354|097|S|restlessness, excitement, and talking more than normal. Tell your||
2354|098|S|doctor right away if you notice any of these effects.||
2354|099|S|   A very serious allergic reaction to this drug is rare.||
2354|100|S|However, get medical help right away if you notice any symptoms||
2354|101|S|of a serious allergic reaction, including: rash, itching/swelling||
2354|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2354|103|S|breathing.||
2354|104|S|   This is not a complete list of possible side effects. If you||
2354|105|S|notice other effects not listed above, contact your doctor or||
2354|106|S|pharmacist.||
2354|107|S|   In the US -||
2354|108|S|   Call your doctor for medical advice about side effects. You||
2354|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2354|110|S|www.fda.gov/medwatch.||
2354|111|S|   In Canada - Call your doctor for medical advice about side||
2354|112|S|effects. You may report side effects to Health Canada at||
2354|113|S|1-866-234-2345.||
2354|114|B|||
2354|115|P|PRECAUTIONS:  Before taking lorazepam, tell your doctor or||
2354|116|P|pharmacist if you are allergic to it; or to other benzodiazepines||
2354|117|P|(such as alprazolam, clonazepam, diazepam); or if you have any||
2354|118|P|other allergies. This product may contain inactive ingredients,||
2354|119|P|which can cause allergic reactions or other problems. Talk to||
2354|120|P|your pharmacist for more details.||
2354|121|P|   Before using this medication, tell your doctor or pharmacist||
2354|122|P|your medical history, especially of: kidney problems, liver||
2354|123|P|problems, glaucoma, lung/breathing problems (such as sleep||
2354|124|P|apnea), mental/mood disorders (such as depression, psychosis,||
2354|125|P|thoughts of suicide), personal or family history of a substance||
2354|126|P|use disorder (such as overuse of or addiction to drugs/alcohol).||
2354|127|P|   This drug may make you dizzy or drowsy or cause blurred||
2354|128|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
2354|129|P|or drowsy. Do not drive, use machinery, or do anything that needs||
2354|130|P|alertness or clear vision until you can do it safely. Avoid||
2354|131|P|alcoholic beverages. Talk to your doctor if you are using||
2354|132|P|marijuana (cannabis).||
2354|133|P|   Before having surgery, tell your doctor or dentist about all||
2354|134|P|the products you use (including prescription drugs,||
2354|135|P|nonprescription drugs, and herbal products).||
2354|136|P|   Older adults may be more sensitive to the side effects of this||
2354|137|P|drug, especially loss of coordination and drowsiness. Loss of||
2354|138|P|coordination and drowsiness may increase the risk of falling.||
2354|139|P|Also, lorazepam may have the opposite of its usual calming effect||
2354|140|P|in older adults (see also Side Effects section).||
2354|141|P|   Tell your doctor if you are pregnant or plan to become||
2354|142|P|pregnant. You should not become pregnant while using lorazepam.||
2354|143|P|Lorazepam may harm an unborn baby. Newborn babies of mothers who||
2354|144|P|use this medication late in pregnancy may have symptoms such as||
2354|145|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
2354|146|P|feeding. If you become pregnant, talk to your doctor right away||
2354|147|P|about the risks and benefits of this medication.||
2354|148|P|   This drug passes into breast milk. Consult your doctor before||
2354|149|P|breastfeeding.||
2354|150|B|||
2354|151|I|DRUG INTERACTIONS:  See also Warning section.||
2354|152|I|   Drug interactions may change how your medications work or||
2354|153|I|increase your risk for serious side effects. This document does||
2354|154|I|not contain all possible drug interactions. Keep a list of all||
2354|155|I|the products you use (including prescription/nonprescription||
2354|156|I|drugs and herbal products) and share it with your doctor and||
2354|157|I|pharmacist. Do not start, stop, or change the dosage of any||
2354|158|I|medicines without your doctor's approval.||
2354|159|I|   Some products that may interact with this drug are: clozapine,||
2354|160|I|kava, sodium oxybate (also known as gamma hydroxybutyrate or||
2354|161|I|GHB).||
2354|162|I|   The risk of serious side effects (such as slow/shallow||
2354|163|I|breathing, severe drowsiness/dizziness) may be increased if this||
2354|164|I|medication is taken with other products that may also cause||
2354|165|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2354|166|I|if you are taking other products such as opioid pain or cough||
2354|167|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2354|168|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
2354|169|I|diazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2354|170|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2354|171|I|diphenhydramine).||
2354|172|I|   Check the labels on all your medicines (such as allergy or||
2354|173|I|cough-and-cold products) because they may contain ingredients||
2354|174|I|that cause drowsiness. Ask your pharmacist about using those||
2354|175|I|products safely.||
2354|176|B|||
2354|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2354|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2354|179|O|poison control center right away. US residents can call||
2354|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2354|181|O|Symptoms of overdose may include: confusion, slow reflexes,||
2354|182|O|clumsiness, deep sleep, and loss of consciousness.||
2354|183|B|||
2354|184|N|NOTES:  Do not share this medication with others. Sharing it is||
2354|185|N|against the law.||
2354|186|N|   Lifestyle changes such as a stress reduction program may||
2354|187|N|increase the effectiveness of this medication. Talk to your||
2354|188|N|doctor or pharmacist about lifestyle changes that might benefit||
2354|189|N|you.||
2354|190|N|   Lab and/or medical tests (such as blood counts, liver||
2354|191|N|function) should be done while you are taking this medication.||
2354|192|N|Keep all medical and lab appointments.||
2354|193|B|||
2354|194|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2354|195|D|remember. If it is near the time of the next dose, skip the||
2354|196|D|missed dose. Take your next dose at the regular time. Do not||
2354|197|D|double the dose to catch up.||
2354|198|B|||
2354|199|R|STORAGE:  Store at room temperature away from light and moisture.||
2354|200|R|Do not store in the bathroom. Keep all medications away from||
2354|201|R|children and pets.||
2354|202|R|   Do not flush medications down the toilet or pour them into a||
2354|203|R|drain unless instructed to do so. Properly discard this product||
2354|204|R|when it is expired or no longer needed. Consult your pharmacist||
2354|205|R|or local waste disposal company.||
2354|206|B|||
2354|207|M|MEDICAL ALERT:  Your condition can cause complications in a||
2354|208|M|medical emergency. For information about enrolling in MedicAlert,||
2354|209|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2354|210|B|||
2354|211|A|Information last revised May 2025.||
2354|212|A|Copyright(c) 2025 First Databank, Inc.||
2354|213|B|||
2355|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2355|002|Z|does NOT have all possible information about this product. This||
2355|003|Z|information does not assure that this product is safe, effective,||
2355|004|Z|or appropriate for you. This information is not individual||
2355|005|Z|medical advice and does not substitute for the advice of your||
2355|006|Z|health care professional. Always ask your health care||
2355|007|Z|professional for complete information about this product and your||
2355|008|Z|specific health needs.||
2355|009|B|||
2355|010|T|BUPROPION HBR EXTENDED-RELEASE (ANTIDEPRESSANT) - ORAL||
2355|011|F|(bue-PROE-pee-on HYE-dro-BROE-mide)||
2355|012|B|||
2355|013|C|COMMON BRAND NAME(S): Aplenzin||
2355|014|B|||
2355|015|W|WARNING:  Bupropion hydrobromide (HBR) is an antidepressant used||
2355|016|W|for smoking cessation and to treat a variety of conditions,||
2355|017|W|including depression and other mental/mood disorders.||
2355|018|W|Antidepressants can help prevent suicidal thoughts/attempts and||
2355|019|W|provide other important benefits. However, a small number of||
2355|020|W|people (especially people younger than 25) who take||
2355|021|W|antidepressants for any condition may experience new or worsening||
2355|022|W|depression, other mental/mood symptoms, or suicidal||
2355|023|W|thoughts/attempts. It is very important to talk with the doctor||
2355|024|W|about the risks and benefits of antidepressant medication, even||
2355|025|W|if treatment is not for a mental/mood condition.||
2355|026|W|   Tell the doctor right away if you notice new or worsening||
2355|027|W|depression/other psychiatric conditions, unusual behavior changes||
2355|028|W|(including possible suicidal thoughts/attempts), or other||
2355|029|W|mental/mood changes (including new/worsening anxiety, panic||
2355|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2355|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
2355|032|W|especially watchful for these symptoms when a new antidepressant||
2355|033|W|is started or when the dose is changed.||
2355|034|W|   If you are using bupropion to quit smoking and experience any||
2355|035|W|of these symptoms, stop taking it and contact your doctor right||
2355|036|W|away. Also, tell your doctor right away if you have any of these||
2355|037|W|symptoms after stopping treatment with bupropion.||
2355|038|B|||
2355|039|U|USES:  This medication is used to treat depression. It is also be||
2355|040|U|used to prevent seasonal affective disorder (SAD), a type of||
2355|041|U|depression that occurs each year at the same time (for example,||
2355|042|U|during winter). Bupropion works by helping to restore the balance||
2355|043|U|of certain natural substances (dopamine, norepinephrine) in the||
2355|044|U|brain.||
2355|045|B|||
2355|046|V|OTHER USES:  This section contains uses of this drug that are not||
2355|047|V|listed in the approved professional labeling for the drug but||
2355|048|V|that may be prescribed by your health care professional. Use this||
2355|049|V|drug for a condition that is listed in this section only if it||
2355|050|V|has been so prescribed by your health care professional.||
2355|051|V|   This drug may also be used for binge eating disorder (BED) or||
2355|052|V|other mental/mood disorders (such as attention deficit||
2355|053|V|hyperactivity disorder-ADHD, depressive phase of bipolar||
2355|054|V|disorder). It may also be used to help people quit smoking by||
2355|055|V|decreasing cravings and nicotine withdrawal effects.||
2355|056|B|||
2355|057|H|HOW TO USE:  Read the Medication Guide provided by your||
2355|058|H|pharmacist before you start using bupropion and each time you get||
2355|059|H|a refill. If you have any questions, ask your doctor or||
2355|060|H|pharmacist.||
2355|061|H|   Take this medication by mouth with or without food as directed||
2355|062|H|by your doctor, usually once daily in the morning. If you have||
2355|063|H|stomach upset, you may take this medication with or after a meal||
2355|064|H|or snack. Taking this medication late in the day may cause||
2355|065|H|trouble sleeping (insomnia). Take this medication regularly to||
2355|066|H|get the most benefit from it. To help you remember, take it at||
2355|067|H|the same time each day.||
2355|068|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
2355|069|H|Doing so can release all of the drug at once, increasing the risk||
2355|070|H|of side effects.||
2355|071|H|   The dosage is based on your medical condition and response to||
2355|072|H|treatment. To reduce your risk of side effects, your doctor may||
2355|073|H|direct you to start this medication at a low dose and gradually||
2355|074|H|increase your dose. Do not increase your dose or use this drug||
2355|075|H|more often or for longer than prescribed. Your condition will not||
2355|076|H|improve any faster, and your risk of side effects will increase.||
2355|077|H|   Do not stop taking this medication without consulting your||
2355|078|H|doctor. Your dose may need to be gradually decreased.||
2355|079|H|   It may take 4 weeks or longer before you get the full benefit||
2355|080|H|of this drug. Tell your doctor if your condition does not get||
2355|081|H|better or if it gets worse.||
2355|082|B|||
2355|083|S|SIDE EFFECTS:  See also Warning section.||
2355|084|S|   Dry mouth, sore throat, dizziness, nausea, vomiting, ringing||
2355|085|S|in the ears, headache, decreased appetite, weight loss,||
2355|086|S|constipation, trouble sleeping, increased sweating, or shaking||
2355|087|S|(tremor) may occur. If any of these effects last or get worse,||
2355|088|S|tell your doctor or pharmacist promptly.||
2355|089|S|   An empty tablet shell may appear in your stool. This effect is||
2355|090|S|harmless because your body has already absorbed the medication.||
2355|091|S|   Remember that this medication has been prescribed because your||
2355|092|S|doctor has judged that the benefit to you is greater than the||
2355|093|S|risk of side effects. Many people using this medication do not||
2355|094|S|have serious side effects.||
2355|095|S|   This medication may raise your blood pressure. Check your||
2355|096|S|blood pressure regularly and tell your doctor if the results are||
2355|097|S|high.||
2355|098|S|   Tell your doctor right away if you have any serious side||
2355|099|S|effects, including: fast/pounding/irregular heartbeat,||
2355|100|S|mental/mood changes (such as anxiety, agitation, confusion,||
2355|101|S|unusual behavior/thinking, memory loss), unusual weight loss or||
2355|102|S|gain.||
2355|103|S|   Get medical help right away if you have any very serious side||
2355|104|S|effects, including: seizure, eye pain/swelling/redness, widened||
2355|105|S|pupils, vision changes (such as seeing rainbows around lights at||
2355|106|S|night, blurred vision).||
2355|107|S|   A very serious allergic reaction to this drug is rare.||
2355|108|S|However, get medical help right away if you notice any symptoms||
2355|109|S|of a serious allergic reaction, including: rash, itching/swelling||
2355|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2355|111|S|breathing.||
2355|112|S|   This is not a complete list of possible side effects. If you||
2355|113|S|notice other effects not listed above, contact your doctor or||
2355|114|S|pharmacist.||
2355|115|S|   In the US -||
2355|116|S|   Call your doctor for medical advice about side effects. You||
2355|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2355|118|S|www.fda.gov/medwatch.||
2355|119|S|   In Canada - Call your doctor for medical advice about side||
2355|120|S|effects. You may report side effects to Health Canada at||
2355|121|S|1-866-234-2345.||
2355|122|B|||
2355|123|P|PRECAUTIONS:  Before taking bupropion, tell your doctor or||
2355|124|P|pharmacist if you are allergic to it; or if you have any other||
2355|125|P|allergies. This product may contain inactive ingredients, which||
2355|126|P|can cause allergic reactions or other problems. Talk to your||
2355|127|P|pharmacist for more details.||
2355|128|P|   Before using this medication, tell your doctor or pharmacist||
2355|129|P|your medical history, especially of: diabetes, heart disease,||
2355|130|P|high blood pressure, kidney problems, liver disease, use/abuse of||
2355|131|P|drugs/alcohol, seizures or conditions that increase your risk of||
2355|132|P|seizures (including brain/head injury, brain tumor, eating||
2355|133|P|disorders such as bulimia/anorexia nervosa), personal or family||
2355|134|P|history of glaucoma (angle-closure type).||
2355|135|P|   This medication should not be used if you are suddenly||
2355|136|P|stopping regular use of sedatives (including benzodiazepines such||
2355|137|P|as lorazepam), drugs used to treat seizures, or alcohol. Doing so||
2355|138|P|may increase your risk of seizures.||
2355|139|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2355|140|P|can make you more dizzy. Do not drive, use machinery, or do||
2355|141|P|anything that needs alertness until you can do it safely. Avoid||
2355|142|P|alcoholic beverages. Talk to your doctor if you are using||
2355|143|P|marijuana (cannabis). Alcohol can also increase your risk of||
2355|144|P|seizures.||
2355|145|P|   Before having surgery, tell your doctor or dentist about all||
2355|146|P|the products you use (including prescription drugs,||
2355|147|P|nonprescription drugs, and herbal products).||
2355|148|P|   Older adults may be more sensitive to the side effects of this||
2355|149|P|drug, especially dizziness and memory loss. Dizziness can||
2355|150|P|increase the risk of falling.||
2355|151|P|   During pregnancy, this medication should be used only when||
2355|152|P|clearly needed. Since untreated mental/mood problems (such as||
2355|153|P|depression, seasonal affective disorder, bipolar disorder) can be||
2355|154|P|a serious condition, do not stop taking this medication unless||
2355|155|P|directed by your doctor. If you are planning pregnancy, become||
2355|156|P|pregnant, or think you may be pregnant, immediately discuss with||
2355|157|P|your doctor the benefits and risks of using this medication||
2355|158|P|during pregnancy.||
2355|159|P|   This drug passes into breast milk and may have undesirable||
2355|160|P|effects on a nursing infant. Consult your doctor before||
2355|161|P|breastfeeding.||
2355|162|B|||
2355|163|I|DRUG INTERACTIONS:  See also Precautions section.||
2355|164|I|   Drug interactions may change how your medications work or||
2355|165|I|increase your risk for serious side effects. This document does||
2355|166|I|not contain all possible drug interactions. Keep a list of all||
2355|167|I|the products you use (including prescription/nonprescription||
2355|168|I|drugs and herbal products) and share it with your doctor and||
2355|169|I|pharmacist. Do not start, stop, or change the dosage of any||
2355|170|I|medicines without your doctor's approval.||
2355|171|I|   Some products that may interact with this drug include:||
2355|172|I|codeine, pimozide, tamoxifen, thioridazine.||
2355|173|I|   Taking MAO inhibitors with this medication may cause a serious||
2355|174|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2355|175|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2355|176|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2355|177|I|selegiline, tranylcypromine) during treatment with this||
2355|178|I|medication. Most MAO inhibitors should also not be taken for two||
2355|179|I|weeks before and after treatment with this medication. Ask your||
2355|180|I|doctor when to start or stop taking this medication.||
2355|181|I|   This medication may interfere with certain medical/lab tests||
2355|182|I|(such as brain scan for Parkinson's disease, urine screening for||
2355|183|I|amphetamines), possibly causing false test results. Make sure lab||
2355|184|I|personnel and all your doctors know you use this drug.||
2355|185|B|||
2355|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2355|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2355|188|O|poison control center right away. US residents can call||
2355|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2355|190|O|Symptoms of overdose may include: seizures, severe confusion,||
2355|191|O|hallucinations, rapid heart rate, loss of consciousness.||
2355|192|B|||
2355|193|N|NOTES:  Do not share this medication with others.||
2355|194|N|   Lab and/or medical tests (such as blood pressure, liver||
2355|195|N|function) may be done while you are taking this medication. Keep||
2355|196|N|all medical and lab appointments. Consult your doctor for more||
2355|197|N|details.||
2355|198|B|||
2355|199|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2355|200|D|next dose at the regular time. Do not double the dose to catch||
2355|201|D|up.||
2355|202|B|||
2355|203|R|STORAGE:  Store at room temperature away from light and moisture.||
2355|204|R|Do not store in the bathroom. Keep all medications away from||
2355|205|R|children and pets.||
2355|206|R|   Do not flush medications down the toilet or pour them into a||
2355|207|R|drain unless instructed to do so. Properly discard this product||
2355|208|R|when it is expired or no longer needed. Consult your pharmacist||
2355|209|R|or local waste disposal company.||
2355|210|B|||
2355|211|A|Information last revised November 2024.||
2355|212|A|Copyright(c) 2025 First Databank, Inc.||
2355|213|B|||
2356|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2356|002|Z|does NOT have all possible information about this product. This||
2356|003|Z|information does not assure that this product is safe, effective,||
2356|004|Z|or appropriate for you. This information is not individual||
2356|005|Z|medical advice and does not substitute for the advice of your||
2356|006|Z|health care professional. Always ask your health care||
2356|007|Z|professional for complete information about this product and your||
2356|008|Z|specific health needs.||
2356|009|B|||
2356|010|T|PALIPERIDONE 6 MONTH - INTRAMUSCULAR INJECTION||
2356|011|F|(PAL-ee-PER-i-done)||
2356|012|B|||
2356|013|C|COMMON BRAND NAME(S): Invega Hafyera||
2356|014|B|||
2356|015|W|WARNING:  There may be a slightly increased risk of serious,||
2356|016|W|possibly fatal side effects (such as stroke, heart failure,||
2356|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
2356|018|W|by older adults with dementia. This medication is not approved||
2356|019|W|for the treatment of dementia-related behavior problems. Discuss||
2356|020|W|the risks and benefits of this medication, as well as other||
2356|021|W|effective and possibly safer treatments for dementia-related||
2356|022|W|behavior problems, with the doctor.||
2356|023|B|||
2356|024|U|USES:  This medication is used to treat a certain mental/mood||
2356|025|U|disorder (schizophrenia). Paliperidone belongs to a class of||
2356|026|U|drugs known as atypical antipsychotics. It works by helping to||
2356|027|U|restore the balance of certain natural substances in the brain.||
2356|028|U|   This long-acting form of paliperidone is used only after you||
2356|029|U|have received treatment with either the monthly injectable form||
2356|030|U|of this drug for at least 4 months, or the every-3-month||
2356|031|U|injectable form for at least 3 months.||
2356|032|B|||
2356|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2356|034|H|from your pharmacist before you start using paliperidone and each||
2356|035|H|time you get a refill. If you have any questions, ask your doctor||
2356|036|H|or pharmacist.||
2356|037|H|   This medication is given by injection into a muscle (buttocks)||
2356|038|H|by a health care professional. It is given as directed by your||
2356|039|H|doctor, usually once every 6 months. The dosage is based on your||
2356|040|H|medical condition and response to treatment.||
2356|041|H|   Use this medication regularly to get the most benefit from it.||
2356|042|H|To help you remember, mark your calendar with a reminder. Keep||
2356|043|H|using this medication even if you feel well. Do not stop using||
2356|044|H|this medication without consulting your doctor.||
2356|045|H|   Tell your doctor if your condition does not get better or if||
2356|046|H|it gets worse.||
2356|047|B|||
2356|048|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness,||
2356|049|S|restlessness, weight gain, or pain/redness/swelling at the||
2356|050|S|injection site may occur. If any of these effects last or get||
2356|051|S|worse, tell your doctor or pharmacist promptly.||
2356|052|S|   Dizziness and lightheadedness can increase the risk of||
2356|053|S|falling. Get up slowly when rising from a sitting or lying||
2356|054|S|position.||
2356|055|S|   Remember that this medication has been prescribed because your||
2356|056|S|doctor has judged that the benefit to you is greater than the||
2356|057|S|risk of side effects. Many people using this medication do not||
2356|058|S|have serious side effects.||
2356|059|S|   Tell your doctor right away if you have any serious side||
2356|060|S|effects, including: difficulty swallowing, shaking (tremor),||
2356|061|S|muscle spasms, interrupted breathing during sleep.||
2356|062|S|   Get medical help right away if you have any very serious side||
2356|063|S|effects, including: fainting, severe dizziness, slow heartbeat,||
2356|064|S|seizures.||
2356|065|S|   Paliperidone may rarely cause a condition known as tardive||
2356|066|S|dyskinesia. In some cases, this condition may be permanent. Tell||
2356|067|S|your doctor right away if you develop any unusual/uncontrolled||
2356|068|S|movements (especially of the face, lips, mouth, tongue, arms, or||
2356|069|S|legs).||
2356|070|S|   This medication may rarely cause a very serious condition||
2356|071|S|called neuroleptic malignant syndrome (NMS). Get medical help||
2356|072|S|right away if you have any of the following symptoms: fever,||
2356|073|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
2356|074|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
2356|075|S|signs of kidney problems (such as change in the amount of urine).||
2356|076|S|   This medication may rarely make your blood sugar rise, which||
2356|077|S|can cause or worsen diabetes. Tell your doctor right away if you||
2356|078|S|have symptoms of high blood sugar such as increased||
2356|079|S|thirst/urination. If you already have diabetes, check your blood||
2356|080|S|sugar regularly as directed and share the results with your||
2356|081|S|doctor. Your doctor may need to adjust your diabetes medication,||
2356|082|S|exercise program, or diet.||
2356|083|S|   This drug may also cause significant weight gain and a rise in||
2356|084|S|your blood cholesterol (or triglyceride) levels. These effects,||
2356|085|S|along with diabetes, may increase your risk for developing heart||
2356|086|S|disease. Discuss the risks and benefits of treatment with your||
2356|087|S|doctor.||
2356|088|S|   Rarely, this medication may increase your blood level of a||
2356|089|S|certain hormone (prolactin). In females, an increase in prolactin||
2356|090|S|levels may result in unwanted breast milk, missed/stopped||
2356|091|S|periods, or difficulty becoming pregnant. In males, it may result||
2356|092|S|in decreased sexual ability, inability to produce sperm, or||
2356|093|S|enlarged breasts. If you develop any of these symptoms, tell your||
2356|094|S|doctor right away.||
2356|095|S|   Rarely, males may have a painful or prolonged erection lasting||
2356|096|S|4 or more hours. If this occurs, stop using this drug and get||
2356|097|S|medical help right away, or permanent problems could occur.||
2356|098|S|   A very serious allergic reaction to this drug is rare.||
2356|099|S|However, get medical help right away if you notice any symptoms||
2356|100|S|of a serious allergic reaction, including: fever, swollen lymph||
2356|101|S|nodes, rash, itching/swelling (especially of the||
2356|102|S|face/tongue/throat), severe dizziness, trouble breathing.||
2356|103|S|   This is not a complete list of possible side effects. If you||
2356|104|S|notice other effects not listed above, contact your doctor or||
2356|105|S|pharmacist.||
2356|106|S|   In the US -||
2356|107|S|   Call your doctor for medical advice about side effects. You||
2356|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2356|109|S|www.fda.gov/medwatch.||
2356|110|S|   In Canada - Call your doctor for medical advice about side||
2356|111|S|effects. You may report side effects to Health Canada at||
2356|112|S|1-866-234-2345.||
2356|113|B|||
2356|114|P|PRECAUTIONS:  See also Warning section.||
2356|115|P|   Before using paliperidone, tell your doctor or pharmacist if||
2356|116|P|you are allergic to it; or to risperidone; or if you have any||
2356|117|P|other allergies. This product may contain inactive ingredients,||
2356|118|P|which can cause allergic reactions or other problems. Talk to||
2356|119|P|your pharmacist for more details.||
2356|120|P|   Before using this medication, tell your doctor or pharmacist||
2356|121|P|your medical history, especially of: kidney disease, low white||
2356|122|P|blood cell count, Parkinson's disease, dementia, certain eye||
2356|123|P|problems (cataracts, glaucoma), seizures, personal or family||
2356|124|P|history of diabetes, high cholesterol/triglyceride levels, heart||
2356|125|P|disease (such as previous heart attack), breathing trouble during||
2356|126|P|sleep (sleep apnea).||
2356|127|P|   Paliperidone may cause a condition that affects the heart||
2356|128|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2356|129|P|serious (rarely fatal) fast/irregular heartbeat and other||
2356|130|P|symptoms (such as severe dizziness, fainting) that need medical||
2356|131|P|attention right away.||
2356|132|P|   The risk of QT prolongation may be increased if you have||
2356|133|P|certain medical conditions or are taking other drugs that may||
2356|134|P|cause QT prolongation. Before using paliperidone, tell your||
2356|135|P|doctor or pharmacist of all the drugs you take and if you have||
2356|136|P|any of the following conditions: certain heart problems (heart||
2356|137|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2356|138|P|history of certain heart problems (QT prolongation in the EKG,||
2356|139|P|sudden cardiac death).||
2356|140|P|   Low levels of potassium or magnesium in the blood may also||
2356|141|P|increase your risk of QT prolongation. This risk may increase if||
2356|142|P|you use certain drugs (such as diuretics/"water pills") or if you||
2356|143|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2356|144|P|Talk to your doctor about using paliperidone safely.||
2356|145|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2356|146|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2356|147|P|machinery, or do anything that needs alertness until you can do||
2356|148|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2356|149|P|are using marijuana (cannabis).||
2356|150|P|   This medication may make you sweat less, making you more||
2356|151|P|likely to get heat stroke. Avoid doing things that may cause you||
2356|152|P|to overheat, such as hard work or exercise in hot weather, or||
2356|153|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2356|154|P|and dress lightly. If you overheat, quickly look for a place to||
2356|155|P|cool down and rest. Get medical help right away if you have a||
2356|156|P|fever that does not go away, mental/mood changes, headache, or||
2356|157|P|dizziness.||
2356|158|P|   Before having surgery (including cataract/glaucoma eye||
2356|159|P|surgery), tell your doctor or dentist if you are using or have||
2356|160|P|ever used this medication, and about all the other products you||
2356|161|P|use (including prescription drugs, nonprescription drugs, and||
2356|162|P|herbal products).||
2356|163|P|   Older adults may be more sensitive to the side effects of this||
2356|164|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
2356|165|P|prolongation (see above). Drowsiness, dizziness, and||
2356|166|P|lightheadedness can increase the risk of falling.||
2356|167|P|   During pregnancy, this medication should be used only when||
2356|168|P|clearly needed. Babies born to mothers who have used this drug||
2356|169|P|during the last 3 months of pregnancy may rarely develop symptoms||
2356|170|P|including muscle stiffness or shakiness, drowsiness,||
2356|171|P|feeding/breathing difficulties, or constant crying. If you notice||
2356|172|P|any of these symptoms in your newborn especially during their||
2356|173|P|first month, tell the doctor right away.||
2356|174|P|   Since untreated mental/mood problems (such as schizophrenia)||
2356|175|P|can be a serious condition, do not stop taking this medication||
2356|176|P|unless directed by your doctor. If you are planning pregnancy,||
2356|177|P|become pregnant, or think you may be pregnant, discuss with your||
2356|178|P|doctor right away the benefits and risks of using this medication||
2356|179|P|during pregnancy.||
2356|180|P|   This medication passes into breast milk and may have||
2356|181|P|undesirable effects on a nursing infant. Tell the doctor right||
2356|182|P|away if your baby develops symptoms such as muscle stiffness or||
2356|183|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
2356|184|P|your doctor before breastfeeding.||
2356|185|B|||
2356|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2356|187|I|medications work or increase your risk for serious side effects.||
2356|188|I|This document does not contain all possible drug interactions.||
2356|189|I|Keep a list of all the products you use (including||
2356|190|I|prescription/nonprescription drugs and herbal products) and share||
2356|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
2356|192|I|the dosage of any medicines without your doctor's approval.||
2356|193|I|   A product that may interact with this drug is: metoclopramide.||
2356|194|I|   Many drugs besides paliperidone may affect the heart rhythm||
2356|195|I|(QT prolongation), including amiodarone, chlorpromazine,||
2356|196|I|disopyramide, dofetilide, dronedarone, moxifloxacin, quinidine,||
2356|197|I|sotalol, procainamide, thioridazine, among others.||
2356|198|I|   Tell your doctor or pharmacist if you are taking other||
2356|199|I|products that cause drowsiness such as opioid pain or cough||
2356|200|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2356|201|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2356|202|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2356|203|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2356|204|I|diphenhydramine).||
2356|205|I|   Check the labels on all your medicines (such as allergy or||
2356|206|I|cough-and-cold products) because they may contain ingredients||
2356|207|I|that cause drowsiness. Ask your pharmacist about using those||
2356|208|I|products safely.||
2356|209|B|||
2356|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2356|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2356|212|O|poison control center right away. US residents can call||
2356|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2356|214|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
2356|215|O|fast/irregular heartbeat, muscle stiffness/spasms, restlessness,||
2356|216|O|unusual/uncontrolled movements.||
2356|217|B|||
2356|218|N|NOTES:  Lab and/or medical tests (such as blood sugar, kidney||
2356|219|N|function, cholesterol/triglyceride levels, blood pressure,||
2356|220|N|weight) should be done while you are using this medication. Keep||
2356|221|N|all medical and lab appointments. Consult your doctor for more||
2356|222|N|details.||
2356|223|B|||
2356|224|D|MISSED DOSE:  It is important to get each dose of this medication||
2356|225|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2356|226|D|right away for a new dosing schedule.||
2356|227|B|||
2356|228|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2356|229|R|doctor's office and will not be stored at home.||
2356|230|B|||
2356|231|A|Information last revised October 2024.||
2356|232|A|Copyright(c) 2025 First Databank, Inc.||
2356|233|B|||
2357|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2357|002|Z|does NOT have all possible information about this product. This||
2357|003|Z|information does not assure that this product is safe, effective,||
2357|004|Z|or appropriate for you. This information is not individual||
2357|005|Z|medical advice and does not substitute for the advice of your||
2357|006|Z|health care professional. Always ask your health care||
2357|007|Z|professional for complete information about this product and your||
2357|008|Z|specific health needs.||
2357|009|B|||
2357|010|T|TREOSULFAN - INJECTION||
2357|011|B|||
2357|012|C|COMMON BRAND NAME(S): Grafapex||
2357|013|B|||
2357|014|W|WARNING:  This medication decreases bone marrow function, an||
2357|015|W|effect that may lead to a low number of blood cells such as red||
2357|016|W|cells, white cells, and platelets. This effect can cause anemia,||
2357|017|W|decrease your body's ability to fight an infection, or cause easy||
2357|018|W|bruising/bleeding. Tell your doctor right away if you develop any||
2357|019|W|of the following symptoms: unusual tiredness, pale skin, signs of||
2357|020|W|an infection (such as sore throat that doesn't go away, fever,||
2357|021|W|chills), easy bruising/bleeding.||
2357|022|W|   Your doctor will monitor you closely while you are using this||
2357|023|W|medication. Keep all medical and lab appointments.||
2357|024|B|||
2357|025|U|USES:  Treosulfan is used by patients to prepare for stem cell||
2357|026|U|transplant treatment for acute myeloid leukemia-AML or||
2357|027|U|myelodysplastic syndrome-MDS.||
2357|028|B|||
2357|029|H|HOW TO USE:  Treosulfan is given by injection into a vein as||
2357|030|H|directed by your doctor, usually for 3 days in a row before||
2357|031|H|receiving a stem cell transplant. It is given over 2 hours by a||
2357|032|H|health care professional. Your doctor may also prescribe other||
2357|033|H|medications to help prevent side effects (such as||
2357|034|H|nausea/vomiting) caused by this medication. To decrease the risk||
2357|035|H|of skin disorders (such as rash), do not use skin cream on the||
2357|036|H|days you receive this medication and keep the skin clean and dry.||
2357|037|H|This medication may pass out of your body in your urine after the||
2357|038|H|injection. If this medication is used by a small child, change||
2357|039|H|diapers often during the first 6 to 12 hours after each||
2357|040|H|injection.||
2357|041|H|   The dosage is based on your medical condition, body size, and||
2357|042|H|response to treatment.||
2357|043|B|||
2357|044|S|SIDE EFFECTS:  See also Warning section.||
2357|045|S|   Nausea, vomiting, diarrhea, loss of appetite,||
2357|046|S|stomach/abdominal pain, dizziness, swelling of feet/hands,||
2357|047|S|muscle/joint/back pain, headache, or trouble sleeping may occur.||
2357|048|S|Nausea and vomiting can be severe. In some cases, your doctor may||
2357|049|S|prescribe medication to prevent or relieve nausea and vomiting.||
2357|050|S|Eating several small meals, not eating before treatment, or||
2357|051|S|limiting activity may help lessen some of these effects. If any||
2357|052|S|of these effects last or get worse, tell your doctor or||
2357|053|S|pharmacist promptly.||
2357|054|S|   Pain or sores in the mouth and throat may occur. Brush your||
2357|055|S|teeth carefully/gently, avoid using mouthwash that contains||
2357|056|S|alcohol, and rinse your mouth often with cool water mixed with||
2357|057|S|baking soda or salt. It may also be best to eat soft, moist||
2357|058|S|foods.||
2357|059|S|   Temporary hair loss may occur. Normal hair growth should||
2357|060|S|return after treatment has ended.||
2357|061|S|   People using this medication may have serious side effects.||
2357|062|S|However, you have been prescribed this drug because your doctor||
2357|063|S|has judged that the benefit to you is greater than the risk of||
2357|064|S|side effects. Careful monitoring by your doctor may decrease your||
2357|065|S|risk.||
2357|066|S|   Tell your doctor right away if you have any serious side||
2357|067|S|effects, including: signs of liver disease (such as||
2357|068|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
2357|069|S|yellowing eyes/skin, dark urine), fast/slow/irregular heartbeat,||
2357|070|S|seizures, pain/redness/swelling at the injection site.||
2357|071|S|   Treosulfan may increase the risk of developing other cancers.||
2357|072|S|Consult your doctor for more details.||
2357|073|S|   Treosulfan can commonly cause a rash that is usually not||
2357|074|S|serious. However, you may not be able to tell it apart from a||
2357|075|S|rare rash that could be a sign of a severe reaction. Tell your||
2357|076|S|doctor right away if you develop any rash.||
2357|077|S|   A very serious allergic reaction to this drug is rare.||
2357|078|S|However, get medical help right away if you notice any symptoms||
2357|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2357|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2357|081|S|breathing.||
2357|082|S|   This is not a complete list of possible side effects. If you||
2357|083|S|notice other effects not listed above, contact your doctor or||
2357|084|S|pharmacist.||
2357|085|S|   In the US -||
2357|086|S|   Call your doctor for medical advice about side effects. You||
2357|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2357|088|S|www.fda.gov/medwatch.||
2357|089|S|   In Canada - Call your doctor for medical advice about side||
2357|090|S|effects. You may report side effects to Health Canada at||
2357|091|S|1-866-234-2345.||
2357|092|B|||
2357|093|P|PRECAUTIONS:  Before receiving treosulfan, tell your doctor or||
2357|094|P|pharmacist if you are allergic to it; or if you have any other||
2357|095|P|allergies. This product may contain inactive ingredients, which||
2357|096|P|can cause allergic reactions or other problems. Talk to your||
2357|097|P|pharmacist for more details.||
2357|098|P|   Before using this medication, tell your doctor or pharmacist||
2357|099|P|your medical history, especially of: blood/bone marrow disorders||
2357|100|P|(such as bone marrow suppression, neutropenia, thrombocytopenia,||
2357|101|P|anemia), brain disorders (such as seizures).||
2357|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2357|103|P|can make you more dizzy. Do not drive, use machinery, or do||
2357|104|P|anything that needs alertness until you can do it safely. Limit||
2357|105|P|alcoholic beverages. Talk to your doctor if you are using||
2357|106|P|marijuana (cannabis).||
2357|107|P|   Treosulfan can make you more likely to get infections or may||
2357|108|P|make current infections worse. Stay away from anyone who has an||
2357|109|P|infection that may easily spread (such as chickenpox, COVID-19,||
2357|110|P|measles, flu). Talk to your doctor if you have been exposed to an||
2357|111|P|infection or for more details.||
2357|112|P|   Tell your health care professional that you are using||
2357|113|P|treosulfan before having any immunizations/vaccinations. Avoid||
2357|114|P|contact with people who have recently received live vaccines||
2357|115|P|(such as flu vaccine inhaled through the nose).||
2357|116|P|   To lower the chance of getting cut, bruised, or injured, use||
2357|117|P|caution with sharp objects like razors and nail cutters, and||
2357|118|P|avoid activities such as contact sports.||
2357|119|P|   Before having surgery, tell your doctor or dentist about all||
2357|120|P|the products you use (including prescription drugs,||
2357|121|P|nonprescription drugs, and herbal products).||
2357|122|P|   Tell your doctor if you are pregnant or plan to become||
2357|123|P|pregnant. You should not become pregnant while using treosulfan.||
2357|124|P|Treosulfan may harm an unborn baby. Your doctor should order a||
2357|125|P|pregnancy test within 7 days before you start this medication.||
2357|126|P|Women using this medication should ask about reliable forms of||
2357|127|P|birth control during treatment and for 6 months after the last||
2357|128|P|dose. Men using this medication should ask about reliable forms||
2357|129|P|of birth control during treatment and for some time after the||
2357|130|P|last dose. If you or your partner becomes pregnant, talk to your||
2357|131|P|doctor right away about the risks and benefits of this||
2357|132|P|medication.||
2357|133|P|   It is unknown if this medication passes into breast milk.||
2357|134|P|Because of the possible risk to the infant, breastfeeding is not||
2357|135|P|recommended while using this medication and for 1 week after the||
2357|136|P|last dose. Consult your doctor before breastfeeding.||
2357|137|B|||
2357|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2357|139|I|medications work or increase your risk for serious side effects.||
2357|140|I|This document does not contain all possible drug interactions.||
2357|141|I|Keep a list of all the products you use (including||
2357|142|I|prescription/nonprescription drugs and herbal products) and share||
2357|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
2357|144|I|the dosage of any medicines without your doctor's approval.||
2357|145|I|   This medication can slow down the removal of other medications||
2357|146|I|from your body, which may affect how they work. Examples of||
2357|147|I|affected drugs include flibanserin, lomitapide, among others.||
2357|148|B|||
2357|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2357|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2357|151|O|poison control center right away. US residents can call||
2357|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2357|153|B|||
2357|154|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2357|155|N|liver function) must be done while you are using this medication.||
2357|156|N|Keep all medical and lab appointments.||
2357|157|B|||
2357|158|D|MISSED DOSE:  It is important to get each dose of this medication||
2357|159|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2357|160|D|right away for a new dosing schedule.||
2357|161|B|||
2357|162|R|STORAGE:  Not applicable. This medication is given in a hospital||
2357|163|R|or clinic and will not be stored at home.||
2357|164|B|||
2357|165|M|MEDICAL ALERT:  Your condition can cause complications in a||
2357|166|M|medical emergency. For information about enrolling in MedicAlert,||
2357|167|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2357|168|B|||
2357|169|A|Information last revised March 2025.||
2357|170|A|Copyright(c) 2025 First Databank, Inc.||
2357|171|B|||
2358|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2358|002|Z|does NOT have all possible information about this product. This||
2358|003|Z|information does not assure that this product is safe, effective,||
2358|004|Z|or appropriate for you. This information is not individual||
2358|005|Z|medical advice and does not substitute for the advice of your||
2358|006|Z|health care professional. Always ask your health care||
2358|007|Z|professional for complete information about this product and your||
2358|008|Z|specific health needs.||
2358|009|B|||
2358|010|T|BELZUTIFAN - ORAL||
2358|011|B|||
2358|012|C|COMMON BRAND NAME(S): Welireg||
2358|013|B|||
2358|014|W|WARNING:  Tell your doctor if you are pregnant or plan to become||
2358|015|W|pregnant. You should not become pregnant while using belzutifan.||
2358|016|W|Belzutifan may harm an unborn baby. Your doctor should order a||
2358|017|W|pregnancy test before you start this medication. Women using this||
2358|018|W|medication should ask about reliable forms of non-hormonal birth||
2358|019|W|control during treatment and for 1 week after the last dose. Men||
2358|020|W|using this medication should ask about reliable forms of birth||
2358|021|W|control during treatment and for 1 week after the last dose. If||
2358|022|W|you or your partner becomes pregnant, talk to your doctor right||
2358|023|W|away about the risks and benefits of this medication.||
2358|024|B|||
2358|025|U|USES:  This medication is used to treat certain types of cancer||
2358|026|U|(such as kidney cancer, pheochromocytoma, paraganglioma). It is||
2358|027|U|also used to treat people with a certain inherited disorder (von||
2358|028|U|Hippel-Lindau disease) who need treatment for tumors/cancers||
2358|029|U|caused by the disease (such as in the kidneys, pancreas,||
2358|030|U|brain/spinal cord). Belzutifan works by slowing or stopping the||
2358|031|U|growth of cancer/tumor cells.||
2358|032|B|||
2358|033|H|HOW TO USE:  Read the Medication Guide provided by your||
2358|034|H|pharmacist before you start taking belzutifan and each time you||
2358|035|H|get a refill. If you have any questions, ask your doctor or||
2358|036|H|pharmacist.||
2358|037|H|   Take this medication by mouth with or without food as directed||
2358|038|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2358|039|H|not chew, crush, or split the tablets. The dosage is based on||
2358|040|H|your medical condition and response to treatment. Children's||
2358|041|H|dosage is also based on weight.||
2358|042|H|   Use this medication regularly to get the most benefit from it.||
2358|043|H|To help you remember, take it at the same time each day.||
2358|044|H|   If you vomit after taking a dose, do not take another dose.||
2358|045|H|Take your next dose at the regular time on the next day.||
2358|046|H|   Tell your doctor if your condition does not get better or if||
2358|047|H|it gets worse.||
2358|048|B|||
2358|049|S|SIDE EFFECTS:  Nausea, vomiting, constipation, abdominal pain,||
2358|050|S|muscle/joint pain, dizziness, or headache may occur. If any of||
2358|051|S|these effects last or get worse, tell your doctor or pharmacist||
2358|052|S|promptly.||
2358|053|S|   People using this medication may have serious side effects.||
2358|054|S|However, you have been prescribed this drug because your doctor||
2358|055|S|has judged that the benefit to you is greater than the risk of||
2358|056|S|side effects. Careful monitoring by your doctor may decrease your||
2358|057|S|risk.||
2358|058|S|   Tell your doctor right away if you have any serious side||
2358|059|S|effects, including: vision changes (such as blurred vision,||
2358|060|S|decreased vision).||
2358|061|S|   This medication commonly causes a decrease in red blood cells||
2358|062|S|in your body (anemia) which can be severe. If your red blood cell||
2358|063|S|counts drop too low, you may need a blood transfusion. Tell your||
2358|064|S|doctor right away if you get symptoms of anemia such as unusual||
2358|065|S|tiredness, feeling cold, shortness of breath, or fast heartbeat.||
2358|066|S|   Belzutifan may cause low oxygen levels in your body. If low||
2358|067|S|oxygen levels occur, your doctor may direct you to temporarily||
2358|068|S|stop this medication, or prescribe oxygen treatment, or treat you||
2358|069|S|in a hospital. Tell your doctor right away if you get symptoms of||
2358|070|S|low oxygen such as shortness of breath or fast heartbeat.||
2358|071|S|   A very serious allergic reaction to this drug is rare.||
2358|072|S|However, get medical help right away if you notice any symptoms||
2358|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2358|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2358|075|S|breathing.||
2358|076|S|   This is not a complete list of possible side effects. If you||
2358|077|S|notice other effects not listed above, contact your doctor or||
2358|078|S|pharmacist.||
2358|079|S|   In the US -||
2358|080|S|   Call your doctor for medical advice about side effects. You||
2358|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2358|082|S|www.fda.gov/medwatch.||
2358|083|S|   In Canada - Call your doctor for medical advice about side||
2358|084|S|effects. You may report side effects to Health Canada at||
2358|085|S|1-866-234-2345.||
2358|086|B|||
2358|087|P|PRECAUTIONS:  Before taking belzutifan, tell your doctor or||
2358|088|P|pharmacist if you are allergic to it; or if you have any other||
2358|089|P|allergies. This product may contain inactive ingredients, which||
2358|090|P|can cause allergic reactions or other problems. Talk to your||
2358|091|P|pharmacist for more details.||
2358|092|P|   Before using this medication, tell your doctor or pharmacist||
2358|093|P|your medical history, especially of: bleeding/blood disorders||
2358|094|P|(such as anemia).||
2358|095|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
2358|096|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
2358|097|P|use machinery, or do anything that needs alertness or clear||
2358|098|P|vision until you can do it safely. Limit alcoholic beverages.||
2358|099|P|Talk to your doctor if you are using marijuana (cannabis).||
2358|100|P|   Before having surgery, tell your doctor or dentist about all||
2358|101|P|the products you use (including prescription drugs,||
2358|102|P|nonprescription drugs, and herbal products).||
2358|103|P|   You should not become pregnant while using belzutifan. If you||
2358|104|P|or your partner becomes pregnant, talk to your doctor right away||
2358|105|P|about the risks and benefits of this medication. (See also||
2358|106|P|Warning section.)||
2358|107|P|   It is unknown if this medication passes into breast milk.||
2358|108|P|Because of the possible risk to the infant, breastfeeding is not||
2358|109|P|recommended while using this medication and for 1 week after the||
2358|110|P|last dose. Consult your doctor before breastfeeding.||
2358|111|B|||
2358|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2358|113|I|medications work or increase your risk for serious side effects.||
2358|114|I|This document does not contain all possible drug interactions.||
2358|115|I|Keep a list of all the products you use (including||
2358|116|I|prescription/nonprescription drugs and herbal products) and share||
2358|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
2358|118|I|the dosage of any medicines without your doctor's approval.||
2358|119|I|   This medication can speed up the removal of other medications||
2358|120|I|from your body, which may affect how they work. Examples of||
2358|121|I|affected drugs include daridorexant, elacestrant, lonafarnib,||
2358|122|I|mavacamten, revumenib, among others.||
2358|123|I|   This medication may decrease the effectiveness of hormonal||
2358|124|I|birth control such as pills, patch, or ring. This could cause||
2358|125|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2358|126|I|use reliable backup birth control methods while using this||
2358|127|I|medication. Also tell your doctor if you have any new spotting or||
2358|128|I|breakthrough bleeding, because these may be signs that your birth||
2358|129|I|control is not working well.||
2358|130|B|||
2358|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2358|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2358|133|O|poison control center right away. US residents can call||
2358|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2358|135|B|||
2358|136|N|NOTES:  Do not share this medication with others.||
2358|137|N|   Lab and/or medical tests (such as complete blood counts,||
2358|138|N|oxygen levels in your body, liver/kidney function, blood glucose)||
2358|139|N|should be done while you are taking this medication. Keep all||
2358|140|N|medical and lab appointments.||
2358|141|B|||
2358|142|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2358|143|D|remember. If you don't remember until the next day, skip the||
2358|144|D|missed dose. Take your next dose at the regular time. Do not||
2358|145|D|double the dose to catch up.||
2358|146|B|||
2358|147|R|STORAGE:  Store at room temperature away from light and moisture.||
2358|148|R|Do not store in the bathroom. Keep the drying agent (desiccant)||
2358|149|R|in the bottle. Tightly close the bottle when not in use. Keep all||
2358|150|R|medications away from children and pets.||
2358|151|R|   Do not flush medications down the toilet or pour them into a||
2358|152|R|drain unless instructed to do so. Properly discard this product||
2358|153|R|when it is expired or no longer needed. Consult your pharmacist||
2358|154|R|or local waste disposal company.||
2358|155|B|||
2358|156|A|Information last revised May 2025.||
2358|157|A|Copyright(c) 2025 First Databank, Inc.||
2358|158|B|||
2359|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2359|002|Z|does NOT have all possible information about this product. This||
2359|003|Z|information does not assure that this product is safe, effective,||
2359|004|Z|or appropriate for you. This information is not individual||
2359|005|Z|medical advice and does not substitute for the advice of your||
2359|006|Z|health care professional. Always ask your health care||
2359|007|Z|professional for complete information about this product and your||
2359|008|Z|specific health needs.||
2359|009|B|||
2359|010|T|MOBOCERTINIB - ORAL||
2359|011|B|||
2359|012|C|COMMON BRAND NAME(S): Exkivity||
2359|013|B|||
2359|014|W|WARNING:  Mobocertinib may cause a condition that affects the||
2359|015|W|heart rhythm (QT prolongation), which can lead to a serious||
2359|016|W|(rarely fatal) fast/irregular heartbeat. Your doctor will monitor||
2359|017|W|you closely before and during treatment with this medication.||
2359|018|W|Keep all medical and lab appointments.||
2359|019|W|   Be sure to tell your doctor and pharmacist about all the||
2359|020|W|products you use (including prescription drugs, nonprescription||
2359|021|W|drugs, and herbal products) since some drugs may also affect the||
2359|022|W|heart rhythm (QT prolongation) or may increase the levels of this||
2359|023|W|medication, which can increase the risk of side effects. See also||
2359|024|W|Drug Interactions section.||
2359|025|B|||
2359|026|U|USES:  This medication is used to treat lung cancer. Mobocertinib||
2359|027|U|belongs to a class of drugs known as kinase inhibitors. It works||
2359|028|U|by slowing or stopping the growth of cancer cells. It binds to a||
2359|029|U|certain protein (epidermal growth factor receptor-EGFR) in some||
2359|030|U|tumors.||
2359|031|B|||
2359|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2359|033|H|from your pharmacist before you start taking mobocertinib and||
2359|034|H|each time you get a refill. If you have any questions, ask your||
2359|035|H|doctor or pharmacist.||
2359|036|H|   Take this medication by mouth with or without food as directed||
2359|037|H|by your doctor, usually once daily. Swallow the capsules whole.||
2359|038|H|Do not crush, chew, or open the capsules or dissolve the contents||
2359|039|H|in the capsules.||
2359|040|H|   The dosage is based on your medical condition, response to||
2359|041|H|treatment, and other medications you may be taking. Be sure to||
2359|042|H|tell your doctor and pharmacist about all the products you use||
2359|043|H|(including prescription drugs, nonprescription drugs, and herbal||
2359|044|H|products).||
2359|045|H|   If you vomit after taking a dose, do not take another dose at||
2359|046|H|that time. Take your next dose at the regular time.||
2359|047|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2359|048|H|using this medication unless your doctor or pharmacist says you||
2359|049|H|may do so safely. Grapefruit can increase the chance of side||
2359|050|H|effects with this medicine. Ask your doctor or pharmacist for||
2359|051|H|more details.||
2359|052|H|   Use this medication regularly to get the most benefit from it.||
2359|053|H|To help you remember, take it at the same time each day.||
2359|054|H|   Do not increase your dose or use this drug more often or for||
2359|055|H|longer than prescribed. Your condition will not improve any||
2359|056|H|faster, and your risk of serious side effects will increase.||
2359|057|B|||
2359|058|S|SIDE EFFECTS:  See also Warning section.||
2359|059|S|   Diarrhea, nausea, vomiting, loss of appetite,||
2359|060|S|stomach/abdominal pain, heartburn, mouth sores, weight loss, dry||
2359|061|S|skin, runny nose, muscle/joint pain, tiredness, or headache may||
2359|062|S|occur. If any of these effects last or get worse, tell your||
2359|063|S|doctor or pharmacist promptly.||
2359|064|S|   Temporary hair loss may occur. Normal hair growth should||
2359|065|S|return after treatment has ended.||
2359|066|S|   People using this medication may have serious side effects.||
2359|067|S|However, you have been prescribed this drug because your doctor||
2359|068|S|has judged that the benefit to you is greater than the risk of||
2359|069|S|side effects. Careful monitoring by your doctor may decrease your||
2359|070|S|risk.||
2359|071|S|   Severe diarrhea may result in dehydration. Your doctor should||
2359|072|S|prescribe medication for you in case you have diarrhea. Contact||
2359|073|S|your doctor promptly if you notice any symptoms of dehydration,||
2359|074|S|such as unusual decreased urination, unusual dry mouth/thirst, or||
2359|075|S|dizziness/lightheadedness.||
2359|076|S|   This medication may raise your blood pressure. Check your||
2359|077|S|blood pressure regularly and tell your doctor if the results are||
2359|078|S|high.||
2359|079|S|   Tell your doctor right away if you have any serious side||
2359|080|S|effects, including: pain/swelling/redness around the nails, signs||
2359|081|S|of eye problems (such as vision changes, eye redness/pain, eye||
2359|082|S|discharge), signs of kidney problems (such as change in the||
2359|083|S|amount of urine), signs of heart failure (such as shortness of||
2359|084|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
2359|085|S|weight gain).||
2359|086|S|   Get medical help right away if you have any very serious side||
2359|087|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2359|088|S|fainting, new or worsening signs of lung disease (such as trouble||
2359|089|S|breathing, chest pain, cough, fever).||
2359|090|S|   Mobocertinib can commonly cause a rash that is usually not||
2359|091|S|serious. However, you may not be able to tell it apart from a||
2359|092|S|rare rash that could be a sign of a severe reaction. Get medical||
2359|093|S|help right away if you develop any rash.||
2359|094|S|   A very serious allergic reaction to this drug is rare.||
2359|095|S|However, get medical help right away if you notice any symptoms||
2359|096|S|of a serious allergic reaction, including: rash, itching/swelling||
2359|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2359|098|S|breathing.||
2359|099|S|   This is not a complete list of possible side effects. If you||
2359|100|S|notice other effects not listed above, contact your doctor or||
2359|101|S|pharmacist.||
2359|102|S|   In the US -||
2359|103|S|   Call your doctor for medical advice about side effects. You||
2359|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2359|105|S|www.fda.gov/medwatch.||
2359|106|S|   In Canada - Call your doctor for medical advice about side||
2359|107|S|effects. You may report side effects to Health Canada at||
2359|108|S|1-866-234-2345.||
2359|109|B|||
2359|110|P|PRECAUTIONS:  Before taking mobocertinib, tell your doctor or||
2359|111|P|pharmacist if you are allergic to it; or if you have any other||
2359|112|P|allergies. This product may contain inactive ingredients, which||
2359|113|P|can cause allergic reactions or other problems. Talk to your||
2359|114|P|pharmacist for more details.||
2359|115|P|   Before using this medication, tell your doctor or pharmacist||
2359|116|P|your medical history.||
2359|117|P|   Mobocertinib may cause a condition that affects the heart||
2359|118|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2359|119|P|serious (rarely fatal) fast/irregular heartbeat and other||
2359|120|P|symptoms (such as severe dizziness, fainting) that need medical||
2359|121|P|attention right away.||
2359|122|P|   The risk of QT prolongation may be increased if you have||
2359|123|P|certain medical conditions or are taking other drugs that may||
2359|124|P|cause QT prolongation. Before using mobocertinib, tell your||
2359|125|P|doctor or pharmacist of all the drugs you take and if you have||
2359|126|P|any of the following conditions: certain heart problems (heart||
2359|127|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2359|128|P|history of certain heart problems (QT prolongation in the EKG,||
2359|129|P|sudden cardiac death), kidney disease.||
2359|130|P|   Low levels of potassium or magnesium in the blood may also||
2359|131|P|increase your risk of QT prolongation. This risk may increase if||
2359|132|P|you use certain drugs (such as diuretics/"water pills") or if you||
2359|133|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2359|134|P|Talk to your doctor about using mobocertinib safely.||
2359|135|P|   Before having surgery, tell your doctor or dentist about all||
2359|136|P|the products you use (including prescription drugs,||
2359|137|P|nonprescription drugs, and herbal products).||
2359|138|P|   Older adults may be more sensitive to the side effects of this||
2359|139|P|drug, especially QT prolongation (see above).||
2359|140|P|   Tell your doctor if you are pregnant or plan to become||
2359|141|P|pregnant. You should not become pregnant while using||
2359|142|P|mobocertinib. Mobocertinib may harm an unborn baby. Your doctor||
2359|143|P|should order a pregnancy test before you start this medication.||
2359|144|P|Women using this medication should ask about reliable forms of||
2359|145|P|non-hormonal birth control during treatment and for 1 month after||
2359|146|P|the last dose. Men using this medication should ask about||
2359|147|P|reliable forms of birth control during treatment and for 1 week||
2359|148|P|after the last dose. If you or your partner becomes pregnant,||
2359|149|P|talk to your doctor right away about the risks and benefits of||
2359|150|P|this medication.||
2359|151|P|   It is unknown if this drug passes into breast milk. Because of||
2359|152|P|the possible risk to the infant, breastfeeding is not recommended||
2359|153|P|while using this drug and for 1 week after the last dose. Consult||
2359|154|P|your doctor before breastfeeding.||
2359|155|B|||
2359|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2359|157|I|medications work or increase your risk for serious side effects.||
2359|158|I|This document does not contain all possible drug interactions.||
2359|159|I|Keep a list of all the products you use (including||
2359|160|I|prescription/nonprescription drugs and herbal products) and share||
2359|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
2359|162|I|the dosage of any medicines without your doctor's approval.||
2359|163|I|   Many drugs besides mobocertinib may affect the heart rhythm||
2359|164|I|(QT prolongation), such as disopyramide, dronedarone, pimozide,||
2359|165|I|ziprasidone, among others.||
2359|166|I|   Other medications can affect the removal of mobocertinib from||
2359|167|I|your body, which may affect how mobocertinib works. Examples||
2359|168|I|include azole antifungals (such as itraconazole, ketoconazole),||
2359|169|I|rifamycins (such as rifampin), among others.||
2359|170|I|   This medication may decrease the effectiveness of hormonal||
2359|171|I|birth control such as pills, patch, or ring. This could cause||
2359|172|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2359|173|I|use reliable backup birth control methods while using this||
2359|174|I|medication. Also tell your doctor if you have any new spotting or||
2359|175|I|breakthrough bleeding, because these may be signs that your birth||
2359|176|I|control is not working well.||
2359|177|B|||
2359|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2359|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2359|180|O|poison control center right away. US residents can call||
2359|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2359|182|B|||
2359|183|N|NOTES:  Do not share this medication with others.||
2359|184|N|   Lab and/or medical tests (such as ECG, complete blood count,||
2359|185|N|kidney/liver/heart function, amylase/lipase levels, blood mineral||
2359|186|N|levels) should be done before you start taking this medication||
2359|187|N|and while you are taking it. Keep all medical and lab||
2359|188|N|appointments. Consult your doctor for more details.||
2359|189|B|||
2359|190|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2359|191|D|remember. If it is more than 6 hours after the missed dose, skip||
2359|192|D|the missed dose. Take your next dose at the regular time. Do not||
2359|193|D|double the dose to catch up.||
2359|194|B|||
2359|195|R|STORAGE:  Store at room temperature away from light and moisture.||
2359|196|R|Do not store in the bathroom. Keep all medications away from||
2359|197|R|children and pets.||
2359|198|R|   Do not flush medications down the toilet or pour them into a||
2359|199|R|drain unless instructed to do so. Properly discard this product||
2359|200|R|when it is expired or no longer needed. Consult your pharmacist||
2359|201|R|or local waste disposal company.||
2359|202|B|||
2359|203|A|Information last revised May 2024.||
2359|204|A|Copyright(c) 2025 First Databank, Inc.||
2359|205|B|||
2360|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2360|002|Z|does NOT have all possible information about this product. This||
2360|003|Z|information does not assure that this product is safe, effective,||
2360|004|Z|or appropriate for you. This information is not individual||
2360|005|Z|medical advice and does not substitute for the advice of your||
2360|006|Z|health care professional. Always ask your health care||
2360|007|Z|professional for complete information about this product and your||
2360|008|Z|specific health needs.||
2360|009|B|||
2360|010|T|OLANZAPINE/SAMIDORPHAN - ORAL||
2360|011|F|(oh-LAN-za-peen/SAM-i-DOR-fan)||
2360|012|B|||
2360|013|C|COMMON BRAND NAME(S): Lybalvi||
2360|014|B|||
2360|015|W|WARNING:  There may be a slightly increased risk of serious,||
2360|016|W|possibly fatal side effects (such as stroke, heart failure,||
2360|017|W|fast/irregular heartbeat, pneumonia) when this product is used by||
2360|018|W|older adults with dementia. This product is not approved for the||
2360|019|W|treatment of dementia-related behavior problems. Discuss the||
2360|020|W|risks and benefits of this product, as well as other effective||
2360|021|W|and possibly safer treatments for dementia-related behavior||
2360|022|W|problems, with the doctor.||
2360|023|B|||
2360|024|U|USES:  This combination medication is used to treat certain||
2360|025|U|mental/mood disorders (such as schizophrenia, bipolar disorder).||
2360|026|U|Olanzapine belongs to a class of drugs called atypical||
2360|027|U|antipsychotics. It works by helping to restore the balance of||
2360|028|U|certain natural substances in the brain. Samidorphan belongs to a||
2360|029|U|class of drugs known as opioid antagonists. It reduces the risk||
2360|030|U|of weight gain caused by olanzapine.||
2360|031|B|||
2360|032|H|HOW TO USE:  Read the Medication Guide provided by your||
2360|033|H|pharmacist before you start taking olanzapine/samidorphan and||
2360|034|H|each time you get a refill. If you have any questions, ask your||
2360|035|H|doctor or pharmacist.||
2360|036|H|   Take this product by mouth with or without food as directed by||
2360|037|H|your doctor, usually once daily. Swallow the tablet whole. Do not||
2360|038|H|split the tablet.||
2360|039|H|   The dosage is based on your medical condition and response to||
2360|040|H|treatment. To reduce your risk of side effects, your doctor may||
2360|041|H|direct you to start this product at a low dose and gradually||
2360|042|H|increase your dose. Follow your doctor's instructions carefully.||
2360|043|H|   Take this product regularly to get the most benefit from it.||
2360|044|H|To help you remember, take it at the same time each day. Keep||
2360|045|H|taking this product even if you feel well. Do not stop taking||
2360|046|H|this product without consulting your doctor.||
2360|047|H|   Tell your doctor if your condition does not get better or if||
2360|048|H|it gets worse.||
2360|049|B|||
2360|050|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, stomach||
2360|051|S|upset, dry mouth, constipation, increased appetite, or weight||
2360|052|S|gain may occur. If any of these effects last or get worse, tell||
2360|053|S|your doctor or pharmacist promptly.||
2360|054|S|   Dizziness and lightheadedness can increase the risk of||
2360|055|S|falling. Get up slowly when rising from a sitting or lying||
2360|056|S|position.||
2360|057|S|   Remember that this product has been prescribed because your||
2360|058|S|doctor has judged that the benefit to you is greater than the||
2360|059|S|risk of side effects. Many people using this product do not have||
2360|060|S|serious side effects.||
2360|061|S|   Tell your doctor right away if you have any serious side||
2360|062|S|effects, including: difficulty swallowing, shaking (tremor), slow||
2360|063|S|heartbeat, fainting, mental/mood changes (such as confusion,||
2360|064|S|restlessness), numbness/tingling of arms/legs, yellowing||
2360|065|S|eyes/skin, severe stomach/abdominal pain, trouble urinating,||
2360|066|S|interrupted breathing during sleep.||
2360|067|S|   This product may rarely make your blood sugar rise, which can||
2360|068|S|cause or worsen diabetes. Tell your doctor right away if you have||
2360|069|S|symptoms of high blood sugar such as increased thirst/urination.||
2360|070|S|If you already have diabetes, check your blood sugar regularly as||
2360|071|S|directed and share the results with your doctor. Your doctor may||
2360|072|S|need to adjust your diabetes medication, exercise program, or||
2360|073|S|diet.||
2360|074|S|   This product may also cause significant weight gain and a rise||
2360|075|S|in your blood cholesterol (or triglyceride) levels. These||
2360|076|S|effects, along with diabetes, may increase your risk for||
2360|077|S|developing heart disease. Discuss the risks and benefits of||
2360|078|S|treatment with your doctor. (See also Notes section.)||
2360|079|S|   This product may rarely cause a condition known as tardive||
2360|080|S|dyskinesia. In some cases, this condition may be permanent. Tell||
2360|081|S|your doctor right away if you develop any unusual/uncontrolled||
2360|082|S|movements (especially of the face, lips, mouth, tongue, arms or||
2360|083|S|legs).||
2360|084|S|   This product may increase a certain natural substance||
2360|085|S|(prolactin) made by your body. For females, this increase in||
2360|086|S|prolactin may result in unwanted breast milk, missed/stopped||
2360|087|S|periods, or difficulty becoming pregnant. For males, it may||
2360|088|S|result in decreased sexual ability, inability to produce sperm,||
2360|089|S|or enlarged breasts. If you develop any of these symptoms, tell||
2360|090|S|your doctor right away.||
2360|091|S|   Get medical help right away if you have any very serious side||
2360|092|S|effects, including: seizures.||
2360|093|S|   This product may rarely cause a very serious condition called||
2360|094|S|neuroleptic malignant syndrome (NMS). Get medical help right away||
2360|095|S|if you have any of the following symptoms: fever, muscle||
2360|096|S|stiffness/pain/tenderness/weakness, severe tiredness, severe||
2360|097|S|confusion, sweating, fast/irregular heartbeat, dark urine, signs||
2360|098|S|of kidney problems (such as change in the amount of urine).||
2360|099|S|   A very serious allergic reaction to this drug is rare.||
2360|100|S|However, get medical help right away if you notice any symptoms||
2360|101|S|of a serious allergic reaction, including: fever, swollen lymph||
2360|102|S|nodes, rash, itching/swelling (especially of the||
2360|103|S|face/tongue/throat), severe dizziness, trouble breathing.||
2360|104|S|   This is not a complete list of possible side effects. If you||
2360|105|S|notice other effects not listed above, contact your doctor or||
2360|106|S|pharmacist.||
2360|107|S|   In the US -||
2360|108|S|   Call your doctor for medical advice about side effects. You||
2360|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2360|110|S|www.fda.gov/medwatch.||
2360|111|S|   In Canada - Call your doctor for medical advice about side||
2360|112|S|effects. You may report side effects to Health Canada at||
2360|113|S|1-866-234-2345.||
2360|114|B|||
2360|115|P|PRECAUTIONS:  Before taking olanzapine/samidorphan, tell your||
2360|116|P|doctor or pharmacist if you are allergic to it; or if you have||
2360|117|P|any other allergies. This product may contain inactive||
2360|118|P|ingredients, which can cause allergic reactions or other||
2360|119|P|problems. Talk to your pharmacist for more details.||
2360|120|P|   Before using this medication, tell your doctor or pharmacist||
2360|121|P|your medical history, especially of: personal or family history||
2360|122|P|of a substance use disorder (such as overuse of or addiction to||
2360|123|P|opioids), opioid withdrawal, liver problems, seizures, difficulty||
2360|124|P|swallowing, low white blood cell count, dementia, difficulty||
2360|125|P|urinating (for example, due to enlarged prostate), glaucoma||
2360|126|P|(narrow angle), stomach/intestinal problems (such as blockage,||
2360|127|P|chronic constipation, paralytic ileus), smoking, personal or||
2360|128|P|family history of diabetes, heart disease, high||
2360|129|P|cholesterol/triglyceride levels, breathing trouble during sleep||
2360|130|P|(sleep apnea).||
2360|131|P|   This product may make you dizzy or drowsy. Alcohol or||
2360|132|P|marijuana (cannabis) can make you more dizzy or drowsy. Do not||
2360|133|P|drive, use machinery, or do anything that needs alertness until||
2360|134|P|you can do it safely. Avoid alcoholic beverages. Talk to your||
2360|135|P|doctor if you are using marijuana (cannabis).||
2360|136|P|   Before having surgery, tell your doctor or dentist about all||
2360|137|P|the products you use (including prescription drugs,||
2360|138|P|nonprescription drugs, and herbal products).||
2360|139|P|   This product may make you sweat less, making you more likely||
2360|140|P|to get heat stroke. Avoid doing things that may cause you to||
2360|141|P|overheat, such as hard work or exercise in hot weather, or using||
2360|142|P|hot tubs. When the weather is hot, drink a lot of fluids and||
2360|143|P|dress lightly. If you overheat, quickly look for a place to cool||
2360|144|P|down and rest. Get medical help right away if you have a fever||
2360|145|P|that does not go away, mental/mood changes, headache, or||
2360|146|P|dizziness.||
2360|147|P|   Older adults may be more sensitive to the side effects of this||
2360|148|P|drug, especially drowsiness, constipation, trouble urinating,||
2360|149|P|confusion, dizziness, and lightheadedness. Drowsiness, confusion,||
2360|150|P|dizziness, and lightheadedness can increase the risk of falling.||
2360|151|P|   During pregnancy, this product should be used only when||
2360|152|P|clearly needed. Babies born to mothers who have used olanzapine||
2360|153|P|during the last 3 months of pregnancy may rarely develop symptoms||
2360|154|P|including muscle stiffness or shakiness, drowsiness,||
2360|155|P|feeding/breathing difficulties, or constant crying. If you notice||
2360|156|P|any of these symptoms in your newborn especially during their||
2360|157|P|first month, tell the doctor right away.||
2360|158|P|   Since untreated mental/mood problems (such as schizophrenia,||
2360|159|P|bipolar disorder) can be a serious condition, do not stop taking||
2360|160|P|this product unless directed by your doctor. If you are planning||
2360|161|P|pregnancy, become pregnant, or think you may be pregnant, discuss||
2360|162|P|with your doctor right away the benefits and risks of using this||
2360|163|P|product during pregnancy.||
2360|164|P|   This medication passes into breast milk. Olanzapine may have||
2360|165|P|undesirable effects on a nursing infant. Tell the doctor right||
2360|166|P|away if your baby develops symptoms such as muscle stiffness or||
2360|167|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
2360|168|P|your doctor before breastfeeding.||
2360|169|B|||
2360|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2360|171|I|medications work or increase your risk for serious side effects.||
2360|172|I|This document does not contain all possible drug interactions.||
2360|173|I|Keep a list of all the products you use (including||
2360|174|I|prescription/nonprescription drugs and herbal products) and share||
2360|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
2360|176|I|the dosage of any medicines without your doctor's approval.||
2360|177|I|   A product that may interact with this drug is: metoclopramide.||
2360|178|I|   Taking opioid pain medications (such as morphine, methadone)||
2360|179|I|with this product may cause opioid withdrawal. Do not take any||
2360|180|I|opioids during treatment with this product. The risk of opioid||
2360|181|I|overdose is also higher if you take opioids after recently||
2360|182|I|stopping olanzapine/samidorphan. Opioids should not be taken too||
2360|183|I|soon before and after treatment with olanzapine/samidorphan. Ask||
2360|184|I|your doctor when to start or stop taking olanzapine/samidorphan,||
2360|185|I|and how long to wait before using opioids.||
2360|186|I|   Tell your doctor or pharmacist if you are taking other||
2360|187|I|products that cause drowsiness such as alcohol, marijuana||
2360|188|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2360|189|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2360|190|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2360|191|I|diphenhydramine).||
2360|192|I|   Check the labels on all your medicines (such as allergy or||
2360|193|I|cough-and-cold products) because they may contain ingredients||
2360|194|I|that cause drowsiness. Ask your pharmacist about using those||
2360|195|I|products safely.||
2360|196|I|   This medication may interfere with certain lab tests (such as||
2360|197|I|drug tests), possibly causing false test results. Make sure lab||
2360|198|I|personnel and all your doctors know you use this drug.||
2360|199|B|||
2360|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2360|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2360|202|O|poison control center right away. US residents can call||
2360|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2360|204|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
2360|205|O|fast/irregular heartbeat, unusual/uncontrolled movements,||
2360|206|O|seizures.||
2360|207|B|||
2360|208|N|NOTES:  Do not share this medication with others.||
2360|209|N|   Lab and/or medical tests (such as blood sugar, weight, blood||
2360|210|N|pressure, blood cholesterol/triglyceride levels, liver function)||
2360|211|N|should be done while you are taking this medication. Keep all||
2360|212|N|medical and lab appointments. Consult your doctor for more||
2360|213|N|details.||
2360|214|B|||
2360|215|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2360|216|D|remember. If it is near the time of the next dose, skip the||
2360|217|D|missed dose. Take your next dose at the regular time. Do not||
2360|218|D|double the dose to catch up.||
2360|219|B|||
2360|220|R|STORAGE:  Store at room temperature away from light and moisture.||
2360|221|R|Do not store in the bathroom. Keep all medications away from||
2360|222|R|children and pets.||
2360|223|R|   Do not flush medications down the toilet or pour them into a||
2360|224|R|drain unless instructed to do so. Properly discard this product||
2360|225|R|when it is expired or no longer needed. Consult your pharmacist||
2360|226|R|or local waste disposal company.||
2360|227|B|||
2360|228|A|Information last revised March 2025.||
2360|229|A|Copyright(c) 2025 First Databank, Inc.||
2360|230|B|||
2361|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2361|002|Z|does NOT have all possible information about this product. This||
2361|003|Z|information does not assure that this product is safe, effective,||
2361|004|Z|or appropriate for you. This information is not individual||
2361|005|Z|medical advice and does not substitute for the advice of your||
2361|006|Z|health care professional. Always ask your health care||
2361|007|Z|professional for complete information about this product and your||
2361|008|Z|specific health needs.||
2361|009|B|||
2361|010|T|TISOTUMAB VEDOTIN - INJECTION||
2361|011|F|(tye-SOT-ue-mab ve-DOE-tin)||
2361|012|B|||
2361|013|C|COMMON BRAND NAME(S): Tivdak||
2361|014|B|||
2361|015|W|WARNING:  Tisotumab vedotin may cause serious eye problems. You||
2361|016|W|should have regular eye exams before and during treatment with||
2361|017|W|this medication. Follow your doctor's instructions carefully on||
2361|018|W|what eye drops to use before and after your infusion of this||
2361|019|W|medication. Do not wear contact lenses while you are on treatment||
2361|020|W|with this medication unless directed by the doctor. Tell your||
2361|021|W|doctor right away if you have signs of eye problems, including||
2361|022|W|dry eyes, eye pain/redness/irritation, or blurred/decreased||
2361|023|W|vision. Ask your doctor or pharmacist for more details.||
2361|024|B|||
2361|025|U|USES:  This medication is used to treat cervical cancer. It works||
2361|026|U|by slowing or stopping the growth of cancer cells.||
2361|027|B|||
2361|028|H|HOW TO USE:  See also Warning section.||
2361|029|H|   Read the Medication Guide provided by your pharmacist before||
2361|030|H|you start receiving tisotumab vedotin and each time you get an||
2361|031|H|injection. If you have any questions, ask your doctor or||
2361|032|H|pharmacist.||
2361|033|H|   This medication is given by injection into a vein by a health||
2361|034|H|care professional as directed by your doctor, usually once every||
2361|035|H|3 weeks. The medication is given over 30 minutes.||
2361|036|H|   The dosage is based on your medical condition, weight, and||
2361|037|H|response to treatment.||
2361|038|H|   Use this medication regularly to get the most benefit from it.||
2361|039|H|To help you remember, mark your calendar with a reminder.||
2361|040|B|||
2361|041|S|SIDE EFFECTS:  See also Warning section.||
2361|042|S|   Nosebleeds, constipation, diarrhea, nausea, vomiting, loss of||
2361|043|S|appetite, stomach/abdominal pain, weight loss, tiredness, or||
2361|044|S|muscle/joint pain may occur. If any of these effects last or get||
2361|045|S|worse, tell your doctor or pharmacist promptly.||
2361|046|S|   Temporary hair loss may occur. Normal hair growth should||
2361|047|S|return after treatment has ended.||
2361|048|S|   People using this medication may have serious side effects.||
2361|049|S|However, you have been prescribed this drug because your doctor||
2361|050|S|has judged that the benefit to you is greater than the risk of||
2361|051|S|side effects. Careful monitoring by your doctor may decrease your||
2361|052|S|risk.||
2361|053|S|   Tell your doctor right away if you have any serious side||
2361|054|S|effects, including: easy bruising/bleeding, signs of infection||
2361|055|S|(such as sore throat that doesn't go away, fever, chills, swollen||
2361|056|S|lymph nodes), sores/ulcers in the mouth/nose/genital area, bloody||
2361|057|S|urine, unusual vaginal bleeding, black/tarry stools,||
2361|058|S|numbness/tingling of arms/legs, muscle weakness.||
2361|059|S|   Get medical help right away if you have any very serious side||
2361|060|S|effects, including: signs of lung problems (such as cough that||
2361|061|S|doesn't go away, chest pain, shortness of breath), weakness on||
2361|062|S|one side of the body, confusion.||
2361|063|S|   Tisotumab vedotin can commonly cause a rash that is usually||
2361|064|S|not serious. However, you may not be able to tell it apart from a||
2361|065|S|rare rash that could be a sign of a severe reaction. Get medical||
2361|066|S|help right away if you develop any rash.||
2361|067|S|   A very serious allergic reaction to this drug is rare.||
2361|068|S|However, get medical help right away if you notice any symptoms||
2361|069|S|of a serious allergic reaction, including: rash, itching/swelling||
2361|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2361|071|S|breathing.||
2361|072|S|   This is not a complete list of possible side effects. If you||
2361|073|S|notice other effects not listed above, contact your doctor or||
2361|074|S|pharmacist.||
2361|075|S|   In the US -||
2361|076|S|   Call your doctor for medical advice about side effects. You||
2361|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2361|078|S|www.fda.gov/medwatch.||
2361|079|S|   In Canada - Call your doctor for medical advice about side||
2361|080|S|effects. You may report side effects to Health Canada at||
2361|081|S|1-866-234-2345.||
2361|082|B|||
2361|083|P|PRECAUTIONS:  Before receiving tisotumab vedotin, tell your||
2361|084|P|doctor or pharmacist if you are allergic to it; or if you have||
2361|085|P|any other allergies. This product may contain inactive||
2361|086|P|ingredients, which can cause allergic reactions or other||
2361|087|P|problems. Talk to your pharmacist for more details.||
2361|088|P|   Before using this medication, tell your doctor or pharmacist||
2361|089|P|your medical history, especially of: liver disease, eye problems,||
2361|090|P|nerve problems (such as numbness/tingling), bleeding problems.||
2361|091|P|   To lower the chance of getting cut, bruised, or injured, use||
2361|092|P|caution with sharp objects like razors and nail cutters, and||
2361|093|P|avoid activities such as contact sports.||
2361|094|P|   Before having surgery, tell your doctor or dentist about all||
2361|095|P|the products you use (including prescription drugs,||
2361|096|P|nonprescription drugs, and herbal products).||
2361|097|P|   Older adults may be more sensitive to the side effects of this||
2361|098|P|drug.||
2361|099|P|   Tell your doctor if you are pregnant or plan to become||
2361|100|P|pregnant. You should not become pregnant while using tisotumab||
2361|101|P|vedotin. Tisotumab vedotin may harm an unborn baby. Your doctor||
2361|102|P|should order a pregnancy test before you start this medication.||
2361|103|P|Women using this medication should ask about reliable forms of||
2361|104|P|birth control during treatment and for 2 months after the last||
2361|105|P|dose. Men using this medication should ask about reliable forms||
2361|106|P|of birth control during treatment and for 4 months after the last||
2361|107|P|dose. If you or your partner becomes pregnant, talk to your||
2361|108|P|doctor right away about the risks and benefits of this||
2361|109|P|medication.||
2361|110|P|   It is unknown if this drug passes into breast milk. Because of||
2361|111|P|the possible risk to the infant, breastfeeding is not recommended||
2361|112|P|while using this drug and for 3 weeks after the last dose.||
2361|113|P|Consult your doctor before breastfeeding.||
2361|114|B|||
2361|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2361|116|I|medications work or increase your risk for serious side effects.||
2361|117|I|This document does not contain all possible drug interactions.||
2361|118|I|Keep a list of all the products you use (including||
2361|119|I|prescription/nonprescription drugs and herbal products) and share||
2361|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
2361|121|I|the dosage of any medicines without your doctor's approval.||
2361|122|B|||
2361|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2361|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2361|125|O|poison control center right away. US residents can call||
2361|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2361|127|B|||
2361|128|N|NOTES:  Do not share this medication with others.||
2361|129|N|   Lab and/or medical tests (such as complete blood counts, eye||
2361|130|N|exams, kidney/liver function, blood mineral levels) should be||
2361|131|N|done before you start receiving this medication and while you are||
2361|132|N|receiving it. Keep all medical and lab appointments.||
2361|133|B|||
2361|134|D|MISSED DOSE:  It is important to get each dose of this medication||
2361|135|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2361|136|D|right away for a new dosing schedule.||
2361|137|B|||
2361|138|R|STORAGE:  Not applicable. This medication is given in a hospital||
2361|139|R|or clinic or doctor's office and will not be stored at home.||
2361|140|B|||
2361|141|A|Information last revised April 2025.||
2361|142|A|Copyright(c) 2025 First Databank, Inc.||
2361|143|B|||
2362|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2362|002|Z|does NOT have all possible information about this product. This||
2362|003|Z|information does not assure that this product is safe, effective,||
2362|004|Z|or appropriate for you. This information is not individual||
2362|005|Z|medical advice and does not substitute for the advice of your||
2362|006|Z|health care professional. Always ask your health care||
2362|007|Z|professional for complete information about this product and your||
2362|008|Z|specific health needs.||
2362|009|B|||
2362|010|T|RADIUM RA 223 DICHLORIDE - INJECTION||
2362|011|F|(RAY-dee-um)||
2362|012|B|||
2362|013|C|COMMON BRAND NAME(S): Xofigo||
2362|014|B|||
2362|015|U|USES:  This medication is used to treat prostate cancer and||
2362|016|U|cancer that has spread to bones. Radium Ra 223 dichloride is a||
2362|017|U|radioactive drug. It works by building up in certain cancer cells||
2362|018|U|and causing them to die.||
2362|019|B|||
2362|020|H|HOW TO USE:  This medication is given by slow injection into a||
2362|021|H|vein by a health care professional. It is given as directed by||
2362|022|H|your doctor, usually every 4 weeks for a total of 6 injections.||
2362|023|H|   The dosage is based on your medical condition, weight, lab||
2362|024|H|tests, and response to treatment.||
2362|025|H|   To prevent dehydration, it is important to drink plenty of||
2362|026|H|fluids while you are being treated with this drug. Consult your||
2362|027|H|doctor or pharmacist if you have any questions.||
2362|028|H|   Because this medication releases some radiation and may be||
2362|029|H|present in the blood, urine, or stool for about 1 week after an||
2362|030|H|injection, avoid contact with your blood, urine, or stool for at||
2362|031|H|least 1 week after your treatment. To avoid splashing, sit down||
2362|032|H|on the toilet seat each time you use the bathroom during the||
2362|033|H|1-week period after your injection. When you are done, flush the||
2362|034|H|toilet twice. Afterward, wash your hands well with soap and||
2362|035|H|water. Use medical gowns and gloves if you need to clean up any||
2362|036|H|blood, urine, or stool. If any blood, urine, or stool gets on||
2362|037|H|your clothing, wash the clothing right away and separately from||
2362|038|H|your other clothing.||
2362|039|B|||
2362|040|S|SIDE EFFECTS:  Nausea, diarrhea, or vomiting may occur. If any of||
2362|041|S|these effects last or get worse, tell your doctor or pharmacist||
2362|042|S|promptly.||
2362|043|S|   Dehydration can occur. The risk is increased if you have||
2362|044|S|vomiting or diarrhea that doesn't stop, and you cannot drink||
2362|045|S|normally. Contact your doctor right away if you notice any||
2362|046|S|symptoms of dehydration, such as unusual dry mouth/thirst, fast||
2362|047|S|heartbeat or dizziness/lightheadedness.||
2362|048|S|   People using this medication may have serious side effects.||
2362|049|S|However, you have been prescribed this drug because your doctor||
2362|050|S|has judged that the benefit to you is greater than the risk of||
2362|051|S|side effects. Careful monitoring by your doctor may decrease your||
2362|052|S|risk.||
2362|053|S|   Tell your doctor right away if you have any serious side||
2362|054|S|effects, including: easy bruising/bleeding, signs of kidney||
2362|055|S|damage (such as change in amount of urine).||
2362|056|S|   This medication may increase the risk of bone fractures. Tell||
2362|057|S|your health care provider right away if you have bone pain or||
2362|058|S|changes in movement.||
2362|059|S|   This medication may lower your ability to fight infections.||
2362|060|S|This may make you more likely to get a serious (rarely fatal)||
2362|061|S|infection or make any infection you have worse. Tell your doctor||
2362|062|S|right away if you have any signs of infection (such as sore||
2362|063|S|throat that doesn't go away, fever, chills).||
2362|064|S|   A very serious allergic reaction to this drug is rare.||
2362|065|S|However, get medical help right away if you notice any symptoms||
2362|066|S|of a serious allergic reaction, including: rash, itching/swelling||
2362|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2362|068|S|breathing.||
2362|069|S|   This is not a complete list of possible side effects. If you||
2362|070|S|notice other effects not listed above, contact your doctor or||
2362|071|S|pharmacist.||
2362|072|S|   In the US -||
2362|073|S|   Call your doctor for medical advice about side effects. You||
2362|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2362|075|S|www.fda.gov/medwatch.||
2362|076|S|   In Canada - Call your doctor for medical advice about side||
2362|077|S|effects. You may report side effects to Health Canada at||
2362|078|S|1-866-234-2345.||
2362|079|B|||
2362|080|P|PRECAUTIONS:  Before using radium Ra 223 dichloride tell your||
2362|081|P|doctor or pharmacist if you are allergic to it; or if you have||
2362|082|P|any other allergies. This product may contain inactive||
2362|083|P|ingredients, which can cause allergic reactions or other||
2362|084|P|problems. Talk to your pharmacist for more details.||
2362|085|P|   Before using this medication, tell your doctor or pharmacist||
2362|086|P|your medical history.||
2362|087|P|   This medication can make you more likely to get infections or||
2362|088|P|may make current infections worse. Stay away from anyone who has||
2362|089|P|an infection that may easily spread (such as chickenpox,||
2362|090|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2362|091|P|exposed to an infection or for more details.||
2362|092|P|   Tell your health care professional that you are using radium||
2362|093|P|Ra 223 dichloride before having any immunizations/vaccinations.||
2362|094|P|Avoid contact with people who have recently received live||
2362|095|P|vaccines (such as flu vaccine inhaled through the nose).||
2362|096|P|   To lower the chance of getting cut, bruised, or injured, use||
2362|097|P|caution with sharp objects like razors and nail cutters, and||
2362|098|P|avoid activities such as contact sports.||
2362|099|P|   This medication may increase your risk for other cancers (such||
2362|100|P|as bone cancers). Talk to your doctor for details.||
2362|101|P|   Before having surgery, tell your doctor or dentist about all||
2362|102|P|the products you use (including prescription drugs,||
2362|103|P|nonprescription drugs, and herbal products).||
2362|104|P|   Radium Ra 223 dichloride is not recommended for use by women.||
2362|105|P|   Males with female partners of childbearing age should ask||
2362|106|P|about reliable forms of birth control while using this medication||
2362|107|P|and for 6 months after stopping treatment. Their female partners||
2362|108|P|should also use reliable forms of birth control for the same||
2362|109|P|amount of time.||
2362|110|P|   It is unknown if this medication affects sperm. If you plan to||
2362|111|P|father a child, discuss the risks and benefits of this medication||
2362|112|P|with your doctor.||
2362|113|B|||
2362|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2362|115|I|medications work or increase your risk for serious side effects.||
2362|116|I|This document does not contain all possible drug interactions.||
2362|117|I|Keep a list of all the products you use (including||
2362|118|I|prescription/nonprescription drugs and herbal products) and share||
2362|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
2362|120|I|the dosage of any medicines without your doctor's approval.||
2362|121|I|   A product that may interact with this drug is: abiraterone.||
2362|122|B|||
2362|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2362|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2362|125|O|poison control center right away. US residents can call||
2362|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2362|127|B|||
2362|128|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2362|129|N|kidney function) should be done while you are using this||
2362|130|N|medication. Keep all medical and lab appointments.||
2362|131|B|||
2362|132|D|MISSED DOSE:  It is important to get each dose of this medication||
2362|133|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2362|134|D|right away for a new dosing schedule.||
2362|135|B|||
2362|136|R|STORAGE:  Not applicable. This medication is given in a hospital||
2362|137|R|or clinic and will not be stored at home.||
2362|138|B|||
2362|139|M|MEDICAL ALERT:  Your condition can cause complications in a||
2362|140|M|medical emergency. For information about enrolling in MedicAlert,||
2362|141|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2362|142|B|||
2362|143|A|Information last revised April 2025.||
2362|144|A|Copyright(c) 2025 First Databank, Inc.||
2362|145|B|||
2363|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2363|002|Z|does NOT have all possible information about this product. This||
2363|003|Z|information does not assure that this product is safe, effective,||
2363|004|Z|or appropriate for you. This information is not individual||
2363|005|Z|medical advice and does not substitute for the advice of your||
2363|006|Z|health care professional. Always ask your health care||
2363|007|Z|professional for complete information about this product and your||
2363|008|Z|specific health needs.||
2363|009|B|||
2363|010|T|METOPROLOL TARTRATE EXTENDED-RELEASE - ORAL||
2363|011|F|(MET-oh-PROE-lol TAR-tate)||
2363|012|B|||
2363|013|W|WARNING:  Do not stop taking this medication without consulting||
2363|014|W|your doctor. Some conditions may become worse when you suddenly||
2363|015|W|stop this drug. Some people who have suddenly stopped taking||
2363|016|W|similar drugs have had chest pain, heart attack, and irregular||
2363|017|W|heartbeat. If your doctor decides you should no longer use this||
2363|018|W|drug, your doctor may direct you to gradually decrease your dose||
2363|019|W|over 1 to 2 weeks.||
2363|020|W|   When gradually stopping this medication, it is recommended||
2363|021|W|that you temporarily limit physical activity to decrease strain||
2363|022|W|on the heart. Get medical help right away if you develop chest||
2363|023|W|pain/tightness/pressure, chest pain spreading to the||
2363|024|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
2363|025|W|fast/irregular heartbeat.||
2363|026|B|||
2363|027|U|USES:  This medication is a beta-blocker used to treat chest pain||
2363|028|U|(angina), heart failure, and high blood pressure. Lowering high||
2363|029|U|blood pressure helps prevent strokes, heart attacks, and kidney||
2363|030|U|problems.||
2363|031|U|   This drug works by blocking the action of certain natural||
2363|032|U|chemicals in your body (such as epinephrine) that affect the||
2363|033|U|heart and blood vessels. This lowers heart rate, blood pressure,||
2363|034|U|and strain on the heart.||
2363|035|B|||
2363|036|V|OTHER USES:  This section contains uses of this drug that are not||
2363|037|V|listed in the approved US professional labeling for the drug but||
2363|038|V|that may be prescribed by your health care professional. Use this||
2363|039|V|drug for a condition that is listed in this section only if it||
2363|040|V|has been so prescribed by your health care professional.||
2363|041|V|   This drug may also be used for irregular heartbeats or after||
2363|042|V|an acute heart attack to improve survival. It may also be used to||
2363|043|V|reduce the risk of migraine headaches.||
2363|044|B|||
2363|045|H|HOW TO USE:  See also Warning section.||
2363|046|H|   Take this medication by mouth as directed by your doctor,||
2363|047|H|usually once daily. Take this medication with or right after a||
2363|048|H|meal.||
2363|049|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
2363|050|H|Doing so can release all of the drug at once, increasing the risk||
2363|051|H|of side effects.||
2363|052|H|   To reduce your risk of side effects, your doctor may direct||
2363|053|H|you to start this medication at a low dose and gradually increase||
2363|054|H|your dose. Follow your doctor's instructions carefully. The||
2363|055|H|dosage is based on your medical condition and response to||
2363|056|H|treatment.||
2363|057|H|   Use this medication regularly to get the most benefit from it.||
2363|058|H|To help you remember, take it at the same time each day. Do not||
2363|059|H|suddenly stop taking this medication without consulting your||
2363|060|H|doctor. Your condition may become worse when the drug is suddenly||
2363|061|H|stopped.||
2363|062|H|   For the treatment of high blood pressure, it may take several||
2363|063|H|weeks before you get the full benefit of this drug. Keep taking||
2363|064|H|this medication even if you feel well. Most people with high||
2363|065|H|blood pressure do not feel sick.||
2363|066|H|   To prevent chest pain, a second heart attack, or migraine||
2363|067|H|headaches, it is very important to take this medication regularly||
2363|068|H|as prescribed. This drug should not be used to treat chest pain||
2363|069|H|or migraines when they occur. Use other medications to relieve||
2363|070|H|sudden attacks as directed by your doctor (for example,||
2363|071|H|nitroglycerin tablets placed under the tongue for chest pain,||
2363|072|H|"triptan" drugs such as sumatriptan for migraines). Consult your||
2363|073|H|doctor or pharmacist for details.||
2363|074|H|   Tell your doctor if your condition does not get better or if||
2363|075|H|it gets worse (for example, your blood pressure readings remain||
2363|076|H|high or increase, your chest pain or migraines occur more often).||
2363|077|B|||
2363|078|S|SIDE EFFECTS:  See also Warning section.||
2363|079|S|   Drowsiness, dizziness, tiredness, diarrhea, and slow heartbeat||
2363|080|S|may occur. Decreased sexual ability has been reported rarely. If||
2363|081|S|any of these effects last or get worse, tell your doctor or||
2363|082|S|pharmacist promptly.||
2363|083|S|   To reduce the risk of dizziness and lightheadedness, get up||
2363|084|S|slowly when rising from a sitting or lying position.||
2363|085|S|   With some brands of this medication, an empty tablet shell may||
2363|086|S|appear in your stool. This is harmless.||
2363|087|S|   This drug may reduce blood flow to your hands and feet,||
2363|088|S|causing them to feel cold. Smoking may worsen this effect. Dress||
2363|089|S|warmly and avoid tobacco use.||
2363|090|S|   Remember that this medication has been prescribed because your||
2363|091|S|doctor has judged that the benefit to you is greater than the||
2363|092|S|risk of side effects. Many people using this medication do not||
2363|093|S|have serious side effects.||
2363|094|S|   Tell your doctor right away if you have any serious side||
2363|095|S|effects, including: very slow heartbeat, fainting, blue||
2363|096|S|fingers/toes, new or worsening symptoms of heart failure (such as||
2363|097|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
2363|098|S|unusual/sudden weight gain), mental/mood changes (such as||
2363|099|S|confusion, mood swings, depression).||
2363|100|S|   A very serious allergic reaction to this drug is rare.||
2363|101|S|However, get medical help right away if you notice any symptoms||
2363|102|S|of a serious allergic reaction, including: rash, itching/swelling||
2363|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2363|104|S|breathing.||
2363|105|S|   This is not a complete list of possible side effects. If you||
2363|106|S|notice other effects not listed above, contact your doctor or||
2363|107|S|pharmacist.||
2363|108|S|   In the US -||
2363|109|S|   Call your doctor for medical advice about side effects. You||
2363|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2363|111|S|www.fda.gov/medwatch.||
2363|112|S|   In Canada - Call your doctor for medical advice about side||
2363|113|S|effects. You may report side effects to Health Canada at||
2363|114|S|1-866-234-2345.||
2363|115|B|||
2363|116|P|PRECAUTIONS:  Before taking metoprolol, tell your doctor or||
2363|117|P|pharmacist if you are allergic to it; or to other beta-blockers||
2363|118|P|(such as atenolol, propranolol); or if you have any other||
2363|119|P|allergies. This product may contain inactive ingredients, which||
2363|120|P|can cause allergic reactions or other problems. Talk to your||
2363|121|P|pharmacist for more details.||
2363|122|P|   Before using this medication, tell your doctor or pharmacist||
2363|123|P|your medical history, especially of: certain types of heart||
2363|124|P|rhythm problems (such as a slow heartbeat, second- or||
2363|125|P|third-degree atrioventricular block, sick sinus syndrome),||
2363|126|P|breathing problems (such as asthma, chronic bronchitis,||
2363|127|P|emphysema), liver disease, serious allergic reactions, including||
2363|128|P|those needing treatment with epinephrine, blood circulation||
2363|129|P|problems (such as Raynaud's disease, peripheral vascular||
2363|130|P|disease), mental/mood disorders (such as depression), a certain||
2363|131|P|muscle disease (myasthenia gravis).||
2363|132|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2363|133|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2363|134|P|machinery, or do anything that needs alertness until you can do||
2363|135|P|it safely. Limit or avoid alcoholic beverages. Talk to your||
2363|136|P|doctor if you are using marijuana (cannabis).||
2363|137|P|   Before having surgery, tell your doctor or dentist about all||
2363|138|P|the products you use (including prescription drugs,||
2363|139|P|nonprescription drugs, and herbal products).||
2363|140|P|   This product may prevent the fast/pounding heartbeat you would||
2363|141|P|usually feel when your blood sugar level falls too low||
2363|142|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
2363|143|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
2363|144|P|blood sugar level, such as dizziness and sweating, are not||
2363|145|P|affected by this drug.||
2363|146|P|   If you have diabetes, this product may make it harder to||
2363|147|P|control your blood sugar levels. Check your blood sugar levels||
2363|148|P|regularly as directed by your doctor. Tell your doctor right away||
2363|149|P|if you have symptoms of high blood sugar such as increased||
2363|150|P|thirst/urination. Your doctor may need to adjust your diabetes||
2363|151|P|medication, exercise program, or diet.||
2363|152|P|   Children may be at greater risk for low blood sugar||
2363|153|P|(hypoglycemia) while using this drug, especially if they are||
2363|154|P|vomiting or not eating regularly. To help prevent low blood||
2363|155|P|sugar, make sure children eat regularly. If your child cannot eat||
2363|156|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
2363|157|P|as sweating, shaking), tell the doctor right away.||
2363|158|P|   During pregnancy, this medication should be used only when||
2363|159|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2363|160|P|benefits with your doctor.||
2363|161|P|   This drug passes into breast milk but is unlikely to harm a||
2363|162|P|nursing infant. Consult your doctor before breastfeeding.||
2363|163|B|||
2363|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2363|165|I|medications work or increase your risk for serious side effects.||
2363|166|I|This document does not contain all possible drug interactions.||
2363|167|I|Keep a list of all the products you use (including||
2363|168|I|prescription/nonprescription drugs and herbal products) and share||
2363|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
2363|170|I|the dosage of any medicines without your doctor's approval.||
2363|171|I|   A product that may interact with this drug is: fingolimod.||
2363|172|I|   Other medications can affect the removal of metoprolol from||
2363|173|I|your body, which may affect how metoprolol works. Examples||
2363|174|I|include lumefantrine, propafenone, quinidine, SSRI||
2363|175|I|antidepressants (such as fluoxetine, paroxetine), St. John's||
2363|176|I|wort, among others.||
2363|177|I|   Some products have ingredients that could raise your heart||
2363|178|I|rate or blood pressure or worsen your heart failure. Tell your||
2363|179|I|pharmacist what products you are using, and ask how to use them||
2363|180|I|safely (especially cough-and-cold products, diet aids, or NSAIDs||
2363|181|I|such as ibuprofen/naproxen).||
2363|182|B|||
2363|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2363|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2363|185|O|poison control center right away. US residents can call||
2363|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2363|187|O|Symptoms of overdose may include: very slow heartbeat, severe||
2363|188|O|dizziness, severe weakness, fainting, trouble breathing.||
2363|189|B|||
2363|190|N|NOTES:  Do not share this medication with others.||
2363|191|N|   Talk with your doctor about lifestyle changes that may help||
2363|192|N|this medication work better (such as stress reduction programs,||
2363|193|N|exercise, and dietary changes).||
2363|194|N|   Have your blood pressure and pulse (heart rate) checked||
2363|195|N|regularly while taking this medication. Learn how to check your||
2363|196|N|own blood pressure and pulse at home, and share the results with||
2363|197|N|your doctor.||
2363|198|N|   Lab and/or medical tests (such as liver function) may be done||
2363|199|N|while you are taking this medication. Keep all medical and lab||
2363|200|N|appointments. Consult your doctor for more details.||
2363|201|B|||
2363|202|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2363|203|D|remember. If it is near the time of the next dose, skip the||
2363|204|D|missed dose. Take your next dose at the regular time. Do not||
2363|205|D|double the dose to catch up.||
2363|206|B|||
2363|207|R|STORAGE:  Store at room temperature away from light and moisture.||
2363|208|R|Do not store in the bathroom. Keep all medications away from||
2363|209|R|children and pets.||
2363|210|R|   Do not flush medications down the toilet or pour them into a||
2363|211|R|drain unless instructed to do so. Properly discard this product||
2363|212|R|when it is expired or no longer needed. Consult your pharmacist||
2363|213|R|or local waste disposal company.||
2363|214|B|||
2363|215|M|MEDICAL ALERT:  Your condition can cause complications in a||
2363|216|M|medical emergency. For information about enrolling in MedicAlert,||
2363|217|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2363|218|B|||
2363|219|A|Information last revised May 2024.||
2363|220|A|Copyright(c) 2025 First Databank, Inc.||
2363|221|B|||
2364|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2364|002|Z|does NOT have all possible information about this product. This||
2364|003|Z|information does not assure that this product is safe, effective,||
2364|004|Z|or appropriate for you. This information is not individual||
2364|005|Z|medical advice and does not substitute for the advice of your||
2364|006|Z|health care professional. Always ask your health care||
2364|007|Z|professional for complete information about this product and your||
2364|008|Z|specific health needs.||
2364|009|B|||
2364|010|T|ATOGEPANT - ORAL||
2364|011|F|(a-TOE-je-pant)||
2364|012|B|||
2364|013|C|COMMON BRAND NAME(S): Qulipta||
2364|014|B|||
2364|015|U|USES:  This medication is used to prevent migraines. Atogepant||
2364|016|U|may work by blocking the effects of a certain natural substance||
2364|017|U|in the brain that causes migraines (calcitonin gene-related||
2364|018|U|peptide - CGRP).||
2364|019|B|||
2364|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2364|021|H|from your pharmacist before you start taking atogepant and each||
2364|022|H|time you get a refill. If you have any questions, ask your doctor||
2364|023|H|or pharmacist.||
2364|024|H|   Take this medication by mouth with or without food as directed||
2364|025|H|by your doctor, usually once daily. The dosage is based on your||
2364|026|H|medical condition, response to treatment, and other medications||
2364|027|H|you may be taking. Be sure to tell your doctor and pharmacist||
2364|028|H|about all the products you use (including prescription drugs,||
2364|029|H|nonprescription drugs, and herbal products).||
2364|030|H|   Use this medication regularly to get the most benefit from it.||
2364|031|H|To help you remember, take it at the same time each day.||
2364|032|H|   Tell your doctor if your condition does not get better or if||
2364|033|H|it gets worse.||
2364|034|B|||
2364|035|S|SIDE EFFECTS:  Nausea, drowsiness, tiredness, or constipation may||
2364|036|S|occur. If any of these effects last or get worse, tell your||
2364|037|S|doctor or pharmacist promptly.||
2364|038|S|   Remember that this medication has been prescribed because your||
2364|039|S|doctor has judged that the benefit to you is greater than the||
2364|040|S|risk of side effects. Many people using this medication do not||
2364|041|S|have serious side effects.||
2364|042|S|   This medication may raise your blood pressure. Check your||
2364|043|S|blood pressure regularly and tell your doctor if the results are||
2364|044|S|high. Your doctor may control your blood pressure with||
2364|045|S|medication.||
2364|046|S|   Tell your doctor right away if you have any serious side||
2364|047|S|effects, including: blue fingers/toes, cold hands/feet.||
2364|048|S|   A very serious allergic reaction to this drug is rare.||
2364|049|S|However, get medical help right away if you notice any symptoms||
2364|050|S|of a serious allergic reaction, including: rash, itching/swelling||
2364|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2364|052|S|breathing.||
2364|053|S|   This is not a complete list of possible side effects. If you||
2364|054|S|notice other effects not listed above, contact your doctor or||
2364|055|S|pharmacist.||
2364|056|S|   In the US -||
2364|057|S|   Call your doctor for medical advice about side effects. You||
2364|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2364|059|S|www.fda.gov/medwatch.||
2364|060|S|   In Canada - Call your doctor for medical advice about side||
2364|061|S|effects. You may report side effects to Health Canada at||
2364|062|S|1-866-234-2345.||
2364|063|B|||
2364|064|P|PRECAUTIONS:  Before taking atogepant, tell your doctor or||
2364|065|P|pharmacist if you are allergic to it; or if you have any other||
2364|066|P|allergies. This product may contain inactive ingredients, which||
2364|067|P|can cause allergic reactions or other problems. Talk to your||
2364|068|P|pharmacist for more details.||
2364|069|P|   Before using this medication, tell your doctor or pharmacist||
2364|070|P|your medical history, especially of: blood circulation problems||
2364|071|P|(such as Raynaud's disease), high blood pressure, kidney||
2364|072|P|problems, liver problems.||
2364|073|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
2364|074|P|can make you more drowsy. Do not drive, use machinery, or do||
2364|075|P|anything that needs alertness until you can do it safely. Limit||
2364|076|P|alcoholic beverages. Talk to your doctor if you are using||
2364|077|P|marijuana (cannabis).||
2364|078|P|   Before having surgery, tell your doctor or dentist about all||
2364|079|P|the products you use (including prescription drugs,||
2364|080|P|nonprescription drugs, and herbal products).||
2364|081|P|   During pregnancy, this medication should be used only when||
2364|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
2364|083|P|   This medication passes into breast milk. Consult your doctor||
2364|084|P|before breastfeeding.||
2364|085|B|||
2364|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2364|087|I|medications work or increase your risk for serious side effects.||
2364|088|I|This document does not contain all possible drug interactions.||
2364|089|I|Keep a list of all the products you use (including||
2364|090|I|prescription/nonprescription drugs and herbal products) and share||
2364|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2364|092|I|the dosage of any medicines without your doctor's approval.||
2364|093|B|||
2364|094|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2364|095|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2364|096|O|poison control center right away. US residents can call||
2364|097|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2364|098|B|||
2364|099|N|NOTES:  Do not share this medication with others.||
2364|100|N|   Certain foods, beverages, or food additives (such as red wine,||
2364|101|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
2364|102|N|patterns such as irregular eating/sleeping habits or stress may||
2364|103|N|bring on a migraine. Avoiding these "triggers" may help lessen||
2364|104|N|migraine attacks. Consult your doctor for more details.||
2364|105|N|   Lab and/or medical tests (such as liver function, blood||
2364|106|N|pressure) may be done while you are taking this medication. Keep||
2364|107|N|all medical and lab appointments.||
2364|108|B|||
2364|109|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2364|110|D|remember. If it is near the time of the next dose, skip the||
2364|111|D|missed dose. Take your next dose at the regular time. Do not||
2364|112|D|double the dose to catch up.||
2364|113|B|||
2364|114|R|STORAGE:  Store at room temperature away from light and moisture.||
2364|115|R|Do not store in the bathroom. Keep all medications away from||
2364|116|R|children and pets.||
2364|117|R|   Do not flush medications down the toilet or pour them into a||
2364|118|R|drain unless instructed to do so. Properly discard this product||
2364|119|R|when it is expired or no longer needed. Consult your pharmacist||
2364|120|R|or local waste disposal company.||
2364|121|B|||
2364|122|A|Information last revised June 2025.||
2364|123|A|Copyright(c) 2025 First Databank, Inc.||
2364|124|B|||
2365|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2365|002|Z|does NOT have all possible information about this product. This||
2365|003|Z|information does not assure that this product is safe, effective,||
2365|004|Z|or appropriate for you. This information is not individual||
2365|005|Z|medical advice and does not substitute for the advice of your||
2365|006|Z|health care professional. Always ask your health care||
2365|007|Z|professional for complete information about this product and your||
2365|008|Z|specific health needs.||
2365|009|B|||
2365|010|T|ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT) - INJECTION||
2365|011|F|(as-PAR-a-jin-ase er-WIN-ee-a kri-SAN-the-mee)||
2365|012|B|||
2365|013|C|COMMON BRAND NAME(S): Rylaze||
2365|014|B|||
2365|015|U|USES:  This product is used to treat certain types of cancers||
2365|016|U|(acute lymphoblastic leukemia-ALL, lymphoblastic lymphoma-LBL).||
2365|017|U|Asparaginase erwinia chrysanthemi works by starving tumor cells||
2365|018|U|of needed nutrients and slowing tumor cell growth.||
2365|019|B|||
2365|020|H|HOW TO USE:  This medication is given by injection into a muscle||
2365|021|H|as directed by your doctor. The injection is given by a health||
2365|022|H|care professional. The dosage and treatment schedule are based on||
2365|023|H|your medical condition, body size, and response to treatment.||
2365|024|H|   Your doctor may prescribe other medications(s) before each||
2365|025|H|dose to help prevent side effects (such as allergic reactions,||
2365|026|H|nausea).||
2365|027|H|   To get the most benefit, do not miss any doses. To help you||
2365|028|H|remember, mark your calendar with a reminder.||
2365|029|B|||
2365|030|S|SIDE EFFECTS:  Pain or swelling at the injection site, nausea,||
2365|031|S|vomiting, diarrhea, loss of appetite, headache, or tiredness may||
2365|032|S|occur. Nausea and vomiting can be severe. In some cases, your||
2365|033|S|doctor may prescribe medication to prevent or relieve nausea and||
2365|034|S|vomiting. Eating several small meals, not eating before||
2365|035|S|treatment, or limiting activity may help lessen some of these||
2365|036|S|effects. If any of these effects last or get worse, tell your||
2365|037|S|doctor or pharmacist promptly.||
2365|038|S|   Remember that this medication has been prescribed because your||
2365|039|S|doctor has judged that the benefit to you is greater than the||
2365|040|S|risk of side effects. Many people using this medication do not||
2365|041|S|have serious side effects.||
2365|042|S|   Tell your doctor right away if you have any serious side||
2365|043|S|effects, including: signs of liver disease (such as||
2365|044|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2365|045|S|swelling of the stomach/abdomen, pain/redness/swelling of arms or||
2365|046|S|legs, muscle/joint pain, unusual bleeding/bruising (such as nose||
2365|047|S|bleeds, black or bloody stools), signs of high blood sugar (such||
2365|048|S|as increased thirst, frequent urination).||
2365|049|S|   Get medical help right away if you have any very serious side||
2365|050|S|effects, including: vision changes, severe headache, severe||
2365|051|S|dizziness, seizures, chest pain.||
2365|052|S|   This medication may lower your ability to fight infections.||
2365|053|S|This may make you more likely to get a serious (rarely fatal)||
2365|054|S|infection or make any infection you have worse. Tell your doctor||
2365|055|S|right away if you have any signs of infection (such as sore||
2365|056|S|throat that doesn't go away, fever, chills).||
2365|057|S|   A very serious allergic reaction to this drug is rare.||
2365|058|S|However, get medical help right away if you notice any symptoms||
2365|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2365|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2365|061|S|breathing.||
2365|062|S|   This is not a complete list of possible side effects. If you||
2365|063|S|notice other effects not listed above, contact your doctor or||
2365|064|S|pharmacist.||
2365|065|S|   In the US -||
2365|066|S|   Call your doctor for medical advice about side effects. You||
2365|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2365|068|S|www.fda.gov/medwatch.||
2365|069|S|   In Canada - Call your doctor for medical advice about side||
2365|070|S|effects. You may report side effects to Health Canada at||
2365|071|S|1-866-234-2345.||
2365|072|B|||
2365|073|P|PRECAUTIONS:  Before receiving this product, tell your doctor or||
2365|074|P|pharmacist if you are allergic to it; or to any asparaginase||
2365|075|P|products; or if you have any other allergies. This product may||
2365|076|P|contain inactive ingredients, which can cause allergic reactions||
2365|077|P|or other problems. Talk to your pharmacist for more details.||
2365|078|P|   Before using this medication, tell your doctor or pharmacist||
2365|079|P|your medical history, especially of: bleeding/blood problems,||
2365|080|P|pancreatitis, liver disease.||
2365|081|P|   Tell your health care professional that you are using||
2365|082|P|asparaginase erwinia chrysanthemi before having any||
2365|083|P|immunizations/vaccinations. Avoid contact with people who have||
2365|084|P|recently received live vaccines (such as flu vaccine inhaled||
2365|085|P|through the nose).||
2365|086|P|   To lower the chance of getting cut, bruised, or injured, use||
2365|087|P|caution with sharp objects like razors and nail cutters, and||
2365|088|P|avoid activities such as contact sports.||
2365|089|P|   Before having surgery, tell your doctor or dentist about all||
2365|090|P|the products you use (including prescription drugs,||
2365|091|P|nonprescription drugs, and herbal products).||
2365|092|P|   Tell your doctor if you are pregnant or plan to become||
2365|093|P|pregnant. You should not become pregnant while using this||
2365|094|P|medication. Asparaginase erwinia chrysanthemi may harm an unborn||
2365|095|P|baby. Your doctor should order a pregnancy test before you start||
2365|096|P|this medication. Ask about reliable forms of non-hormonal birth||
2365|097|P|control (such as condoms, diaphragm with spermicide) while using||
2365|098|P|this medication and for 3 months after the last dose. If you||
2365|099|P|become pregnant, talk to your doctor right away about the risks||
2365|100|P|and benefits of this medication.||
2365|101|P|   It is unknown if this drug passes into breast milk. Because of||
2365|102|P|the possible risk to the infant, breastfeeding is not recommended||
2365|103|P|while using this drug and for 1 week after the last dose. Consult||
2365|104|P|your doctor before breastfeeding.||
2365|105|B|||
2365|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2365|107|I|medications work or increase your risk for serious side effects.||
2365|108|I|This document does not contain all possible drug interactions.||
2365|109|I|Keep a list of all the products you use (including||
2365|110|I|prescription/nonprescription drugs and herbal products) and share||
2365|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
2365|112|I|the dosage of any medicines without your doctor's approval.||
2365|113|I|   This product may interfere with certain lab tests, possibly||
2365|114|I|causing false test results. Make sure lab personnel and all your||
2365|115|I|doctors know you use this drug.||
2365|116|B|||
2365|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2365|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2365|119|O|poison control center right away. US residents can call||
2365|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2365|121|B|||
2365|122|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2365|123|N|liver function, amylase/lipase levels, blood sugar) should be||
2365|124|N|done while you are using this medication. Keep all medical and||
2365|125|N|lab appointments.||
2365|126|B|||
2365|127|D|MISSED DOSE:  It is important to get each dose of asparaginase||
2365|128|D|erwinia chrysanthemi as scheduled. If you miss a dose, ask your||
2365|129|D|doctor or pharmacist right away for a new dosing schedule.||
2365|130|B|||
2365|131|R|STORAGE:  Not applicable. This medication is given in a hospital||
2365|132|R|or clinic and will not be stored at home.||
2365|133|B|||
2365|134|M|MEDICAL ALERT:  Your condition can cause complications in a||
2365|135|M|medical emergency. For information about enrolling in MedicAlert,||
2365|136|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2365|137|B|||
2365|138|A|Information last revised April 2025.||
2365|139|A|Copyright(c) 2025 First Databank, Inc.||
2365|140|B|||
2366|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2366|002|Z|does NOT have all possible information about this product. This||
2366|003|Z|information does not assure that this product is safe, effective,||
2366|004|Z|or appropriate for you. This information is not individual||
2366|005|Z|medical advice and does not substitute for the advice of your||
2366|006|Z|health care professional. Always ask your health care||
2366|007|Z|professional for complete information about this product and your||
2366|008|Z|specific health needs.||
2366|009|B|||
2366|010|T|COLCHICINE 0.5 MG - ORAL||
2366|011|F|(KOL-chi-seen)||
2366|012|B|||
2366|013|C|COMMON BRAND NAME(S): Lodoco||
2366|014|B|||
2366|015|U|USES:  Colchicine is used by people with heart disease or people||
2366|016|U|who have multiple risk factors for heart disease to help reduce||
2366|017|U|the risk of getting serious related heart and blood vessel||
2366|018|U|problems (such as stroke, heart attack). It is thought to work by||
2366|019|U|decreasing inflammation in the arteries.||
2366|020|U|   Colchicine is not a pain medication and should not be taken to||
2366|021|U|relieve pain.||
2366|022|B|||
2366|023|V|OTHER USES:  This section contains uses of this drug that are not||
2366|024|V|listed in the approved professional labeling for the drug but||
2366|025|V|that may be prescribed by your health care professional. Use this||
2366|026|V|drug for a condition that is listed in this section only if it||
2366|027|V|has been so prescribed by your health care professional.||
2366|028|V|   Colchicine is also available in other brands and other||
2366|029|V|strengths for gout, pain caused by an inherited disease (familial||
2366|030|V|Mediterranean fever), or pericarditis. Do not take this||
2366|031|V|medication with any other product that contains colchicine.||
2366|032|B|||
2366|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2366|034|H|from your pharmacist before you start taking colchicine and each||
2366|035|H|time you get a refill. If you have any questions, ask your doctor||
2366|036|H|or pharmacist.||
2366|037|H|   To reduce the risk of serious heart disease, take this||
2366|038|H|medication by mouth with or without food as directed by your||
2366|039|H|doctor, usually once daily.||
2366|040|H|   If you are using the extended-release tablets, swallow the||
2366|041|H|tablets whole. Do not crush or chew the tablets. Doing so can||
2366|042|H|release all of the drug at once, increasing the risk of side||
2366|043|H|effects.||
2366|044|H|   Use this medication regularly to get the most benefit from it.||
2366|045|H|To help you remember, take it at the same time each day.||
2366|046|H|   Do not increase your dose or use this drug more often or for||
2366|047|H|longer than prescribed. Your condition will not improve any||
2366|048|H|faster, and your risk of side effects will increase. Serious side||
2366|049|H|effects may occur even at usual prescribed doses.||
2366|050|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2366|051|H|using this medication unless your doctor or pharmacist says you||
2366|052|H|may do so safely. Grapefruit can increase the chance of side||
2366|053|H|effects with this medicine. Ask your doctor or pharmacist for||
2366|054|H|more details.||
2366|055|B|||
2366|056|S|SIDE EFFECTS:  Diarrhea, nausea, cramping, abdominal pain, and||
2366|057|S|vomiting may occur. If any of these effects last or get worse,||
2366|058|S|tell your doctor or pharmacist promptly.||
2366|059|S|   Remember that this medication has been prescribed because your||
2366|060|S|doctor has judged that the benefit to you is greater than the||
2366|061|S|risk of side effects. Many people using this medication do not||
2366|062|S|have serious side effects.||
2366|063|S|   Tell your doctor right away if you have any serious side||
2366|064|S|effects, including: fast heartbeat, shortness of breath, signs of||
2366|065|S|infection (such as sore throat that doesn't go away, fever,||
2366|066|S|chills), signs of kidney problems (such as change in the amount||
2366|067|S|of urine), unusual bleeding/bruising, unusual weakness/tiredness.||
2366|068|S|   Stop taking this medication and get medical help right away if||
2366|069|S|you have any very serious side effects, including: muscle||
2366|070|S|weakness or pain, numbness/tingling in your fingers or toes, pale||
2366|071|S|or gray color of the lips/tongue/palms of hands.||
2366|072|S|   A very serious allergic reaction to this drug is rare.||
2366|073|S|However, get medical help right away if you notice any symptoms||
2366|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2366|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2366|076|S|breathing.||
2366|077|S|   This is not a complete list of possible side effects. If you||
2366|078|S|notice other effects not listed above, contact your doctor or||
2366|079|S|pharmacist.||
2366|080|S|   In the US -||
2366|081|S|   Call your doctor for medical advice about side effects. You||
2366|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2366|083|S|www.fda.gov/medwatch.||
2366|084|S|   In Canada - Call your doctor for medical advice about side||
2366|085|S|effects. You may report side effects to Health Canada at||
2366|086|S|1-866-234-2345.||
2366|087|B|||
2366|088|P|PRECAUTIONS:  Before taking colchicine, tell your doctor or||
2366|089|P|pharmacist if you are allergic to it; or if you have any other||
2366|090|P|allergies. This product may contain inactive ingredients, which||
2366|091|P|can cause allergic reactions or other problems. Talk to your||
2366|092|P|pharmacist for more details.||
2366|093|P|   Before using this medication, tell your doctor or pharmacist||
2366|094|P|your medical history, especially of: bleeding/blood problems,||
2366|095|P|kidney problems, liver problems.||
2366|096|P|   This medication can affect how well your body absorbs some||
2366|097|P|foods and nutrients (such as vitamin B12). Consult your doctor or||
2366|098|P|pharmacist for more details.||
2366|099|P|   Before having surgery, tell your doctor or dentist about all||
2366|100|P|the products you use (including prescription drugs,||
2366|101|P|nonprescription drugs, and herbal products).||
2366|102|P|   Older adults may be more sensitive to the side effects of this||
2366|103|P|drug, especially muscle weakness/pain and numbness/tingling in||
2366|104|P|their fingers or toes.||
2366|105|P|   This medication can affect fertility in males. Ask your doctor||
2366|106|P|for more details.||
2366|107|P|   During pregnancy, this medication should be used only when||
2366|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
2366|109|P|   This medication passes into breast milk. Consult your doctor||
2366|110|P|before breastfeeding.||
2366|111|B|||
2366|112|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
2366|113|I|   Drug interactions may change how your medications work or||
2366|114|I|increase your risk for serious side effects. This document does||
2366|115|I|not contain all possible drug interactions. Keep a list of all||
2366|116|I|the products you use (including prescription/nonprescription||
2366|117|I|drugs and herbal products) and share it with your doctor and||
2366|118|I|pharmacist. Do not start, stop, or change the dosage of any||
2366|119|I|medicines without your doctor's approval.||
2366|120|I|   Other medications can affect the removal of colchicine from||
2366|121|I|your body, which may affect how colchicine works or increase the||
2366|122|I|risk of serious side effects. Examples include adagrasib, certain||
2366|123|I|azole antifungals (such as itraconazole, ketoconazole),||
2366|124|I|diltiazem, HIV protease inhibitors (such as atazanavir,||
2366|125|I|darunavir), macrolide antibiotics (such as clarithromycin,||
2366|126|I|erythromycin), ritonavir, telithromycin, tucatinib, verapamil,||
2366|127|I|among others.||
2366|128|I|   Colchicine may rarely cause a certain kind of serious (even||
2366|129|I|fatal) muscle damage (rhabdomyolysis). This muscle damage||
2366|130|I|releases substances that can lead to serious kidney problems. The||
2366|131|I|risk may be increased if other drugs that may also cause||
2366|132|I|rhabdomyolysis are taken along with colchicine. Some affected||
2366|133|I|drugs include: atorvastatin, digoxin, gemfibrozil, pravastatin,||
2366|134|I|simvastatin, among others.||
2366|135|I|   This medication may interfere with certain lab tests, possibly||
2366|136|I|causing false test results. Make sure lab personnel and all your||
2366|137|I|doctors know you use this drug.||
2366|138|I|   Do not take this medication with any other product that||
2366|139|I|contains colchicine.||
2366|140|B|||
2366|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2366|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2366|143|O|poison control center right away. US residents can call||
2366|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2366|145|O|Symptoms of overdose may include: severe||
2366|146|O|nausea/vomiting/diarrhea, abdominal pain, trouble breathing,||
2366|147|O|weakness.||
2366|148|B|||
2366|149|N|NOTES:  Do not share this medication with others.||
2366|150|N|   Lab and/or medical tests (such as complete blood count,||
2366|151|N|kidney/liver function) may be done while you are taking this||
2366|152|N|medication. Keep all medical and lab appointments.||
2366|153|B|||
2366|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2366|155|D|remember. If it is near the time of the next dose, skip the||
2366|156|D|missed dose. Take your next dose at the regular time. Do not||
2366|157|D|double the dose to catch up.||
2366|158|B|||
2366|159|R|STORAGE:  Store at room temperature away from light and moisture.||
2366|160|R|Do not store in the bathroom. Keep all medications away from||
2366|161|R|children and pets.||
2366|162|R|   Do not flush medications down the toilet or pour them into a||
2366|163|R|drain unless instructed to do so. Properly discard this product||
2366|164|R|when it is expired or no longer needed. Consult your pharmacist||
2366|165|R|or local waste disposal company.||
2366|166|B|||
2366|167|A|Information last revised January 2025.||
2366|168|A|Copyright(c) 2025 First Databank, Inc.||
2366|169|B|||
2367|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2367|002|Z|does NOT have all possible information about this product. This||
2367|003|Z|information does not assure that this product is safe, effective,||
2367|004|Z|or appropriate for you. This information is not individual||
2367|005|Z|medical advice and does not substitute for the advice of your||
2367|006|Z|health care professional. Always ask your health care||
2367|007|Z|professional for complete information about this product and your||
2367|008|Z|specific health needs.||
2367|009|B|||
2367|010|T|RUXOLITINIB - TOPICAL||
2367|011|F|(RUX-oh-LI-ti-nib)||
2367|012|B|||
2367|013|C|COMMON BRAND NAME(S): Opzelura||
2367|014|B|||
2367|015|W|WARNING:  This medication may lower your ability to fight||
2367|016|W|infections. This may make you more likely to get a serious||
2367|017|W|infection or make any infection you have worse. People taking||
2367|018|W|ruxolitinib by mouth have had very serious (possibly fatal)||
2367|019|W|infections (such as fungal infections, tuberculosis, herpes||
2367|020|W|zoster). Tell your doctor right away if you have any signs of||
2367|021|W|infection (such as a sore throat that doesn't go away, cough that||
2367|022|W|doesn't go away, fever, chills, unusual sweating, painful skin||
2367|023|W|rash/blisters).||
2367|024|W|   Cancers (such as skin cancer) and blood clots have been||
2367|025|W|reported in people using ruxolitinib cream. Also, another||
2367|026|W|medication similar to ruxolitinib has, when taken by mouth,||
2367|027|W|caused serious (possibly fatal) side effects, including heart||
2367|028|W|problems, blood clots, and cancer (such as lymphoma). Before||
2367|029|W|using ruxolitinib, tell your doctor or pharmacist if you have a||
2367|030|W|history of heart disease, stroke, cancer, or any risk factors for||
2367|031|W|heart disease (such as high blood pressure, diabetes, previous||
2367|032|W|blood clots, high cholesterol, smoking or history of smoking).||
2367|033|W|Patients who are 50 years of age or older may be at increased||
2367|034|W|risk for heart problems or blood clots. Discuss the risks and||
2367|035|W|benefits of treatment with your doctor. Get medical help right||
2367|036|W|away if you have symptoms such as shortness of breath/rapid||
2367|037|W|breathing, chest/jaw/left arm pain, unusual sweating, sudden||
2367|038|W|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
2367|039|W|sudden/severe headaches, trouble speaking, confusion, sudden||
2367|040|W|vision changes, or weakness on one side of the body.||
2367|041|B|||
2367|042|U|USES:  The cream form of ruxolitinib is used to treat certain||
2367|043|U|skin conditions such as eczema (atopic dermatitis) and vitiligo.||
2367|044|U|Eczema is an allergic-type condition that causes red, irritated,||
2367|045|U|and itchy skin. Vitiligo is a condition where the immune system||
2367|046|U|attacks skin cells that make the color in your skin. This drug||
2367|047|U|works by weakening the skin's defense (immune) system, which can||
2367|048|U|help relieve symptoms of the skin conditions. Ruxolitinib belongs||
2367|049|U|to a class of drugs known as kinase inhibitors.||
2367|050|B|||
2367|051|H|HOW TO USE:  Read the Medication Guide provided by your||
2367|052|H|pharmacist before you start using ruxolitinib and each time you||
2367|053|H|get a refill. If you have any questions, ask your doctor or||
2367|054|H|pharmacist.||
2367|055|H|   Wash your hands with soap and water before using this||
2367|056|H|medication. Apply a thin layer to the affected areas of skin as||
2367|057|H|directed by your doctor, usually twice daily. Rub the medication||
2367|058|H|into the skin gently and completely. Wash your hands after using||
2367|059|H|this product unless your hands are being treated. If your doctor||
2367|060|H|recommends a moisturizer, apply it after this medication.||
2367|061|H|   This product is for use on the skin only. Avoid getting this||
2367|062|H|medication in your eyes or on the inside of your nose or mouth.||
2367|063|H|If you do get the medication in those areas, flush with plenty of||
2367|064|H|water. Do not apply this medication to open wounds or infected||
2367|065|H|areas. Do not cover the treated area with plastic or waterproof||
2367|066|H|bandages unless directed to do so by your doctor.||
2367|067|H|   Use this medication exactly as directed. For treating eczema,||
2367|068|H|your doctor may instruct you to stop using this product once your||
2367|069|H|eczema has cleared and to start using it again if symptoms||
2367|070|H|reappear. Consult your doctor for details.||
2367|071|H|   Tell your doctor if your condition does not get better (after||
2367|072|H|8 weeks of treatment for eczema or after 24 weeks of treatment||
2367|073|H|for vitiligo) or if your condition gets worse.||
2367|074|B|||
2367|075|S|SIDE EFFECTS:  See also Warning section.||
2367|076|S|   Skin irritation/pain may occur at the application site. If||
2367|077|S|this effect lasts or gets worse, tell your doctor or pharmacist||
2367|078|S|promptly.||
2367|079|S|   Remember that this medication has been prescribed because your||
2367|080|S|doctor has judged that the benefit to you is greater than the||
2367|081|S|risk of side effects. Many people using this medication do not||
2367|082|S|have serious side effects.||
2367|083|S|   Tell your doctor right away if you have any serious side||
2367|084|S|effects, including: signs of anemia (such as unusual tiredness,||
2367|085|S|pale skin), easy bleeding/bruising.||
2367|086|S|   A very serious allergic reaction to this drug is rare.||
2367|087|S|However, get medical help right away if you notice any symptoms||
2367|088|S|of a serious allergic reaction, including: rash, itching/swelling||
2367|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2367|090|S|breathing.||
2367|091|S|   This is not a complete list of possible side effects. If you||
2367|092|S|notice other effects not listed above, contact your doctor or||
2367|093|S|pharmacist.||
2367|094|S|   In the US -||
2367|095|S|   Call your doctor for medical advice about side effects. You||
2367|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2367|097|S|www.fda.gov/medwatch.||
2367|098|S|   In Canada - Call your doctor for medical advice about side||
2367|099|S|effects. You may report side effects to Health Canada at||
2367|100|S|1-866-234-2345.||
2367|101|B|||
2367|102|P|PRECAUTIONS:  See also Warning section.||
2367|103|P|   Before using ruxolitinib, tell your doctor or pharmacist if||
2367|104|P|you are allergic to it; or if you have any other allergies. This||
2367|105|P|product may contain inactive ingredients, which can cause||
2367|106|P|allergic reactions or other problems. Talk to your pharmacist for||
2367|107|P|more details.||
2367|108|P|   Before using this medication, tell your doctor or pharmacist||
2367|109|P|your medical history, especially of: cancer (such as skin||
2367|110|P|cancer), current/past/returning infections (such as tuberculosis,||
2367|111|P|hepatitis B and C), weakened immune system (for example,||
2367|112|P|following an organ transplant).||
2367|113|P|   Before having surgery, tell your doctor or dentist about all||
2367|114|P|the products you use (including prescription drugs,||
2367|115|P|nonprescription drugs, and herbal products).||
2367|116|P|   This medication may increase your risk of getting skin cancer.||
2367|117|P|Limit your time in the sun. Avoid tanning booths and sunlamps.||
2367|118|P|Use sunscreen and wear protective clothing when outdoors.||
2367|119|P|   During pregnancy, this medication should be used only when||
2367|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
2367|121|P|   It is unknown if this medication passes into breast milk.||
2367|122|P|Because of the possible risk to the infant, breastfeeding is not||
2367|123|P|recommended while using this medication and for 4 weeks after the||
2367|124|P|last dose. Consult your doctor before breastfeeding.||
2367|125|B|||
2367|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2367|127|I|medications work or increase your risk for serious side effects.||
2367|128|I|This document does not contain all possible drug interactions.||
2367|129|I|Keep a list of all the products you use (including||
2367|130|I|prescription/nonprescription drugs and herbal products) and share||
2367|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
2367|132|I|the dosage of any medicines without your doctor's approval.||
2367|133|B|||
2367|134|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2367|135|O|has overdosed and has serious symptoms such as passing out or||
2367|136|O|trouble breathing, call 911. Otherwise, call a poison control||
2367|137|O|center right away. US residents can call 1-800-222-1222. Canada||
2367|138|O|residents can call 1-844-764-7669.||
2367|139|B|||
2367|140|N|NOTES:  Do not share this medication with others.||
2367|141|N|   Lab and/or medical tests (such as complete blood counts,||
2367|142|N|cholesterol/triglyceride levels, skin exams) may be done while||
2367|143|N|you are using this medication. Keep all medical and lab||
2367|144|N|appointments. Consult your doctor for more details.||
2367|145|N|   This medication has been prescribed for your current condition||
2367|146|N|only. Do not use it later for another skin condition unless your||
2367|147|N|doctor tells you to.||
2367|148|N|   If you have eczema, talk with your doctor about other ways to||
2367|149|N|manage your eczema, such as using moisturizers and taking shorter||
2367|150|N|baths/showers.||
2367|151|B|||
2367|152|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2367|153|D|If it is near the time of the next dose, skip the missed dose.||
2367|154|D|Use your next dose at the regular time. Do not double the dose to||
2367|155|D|catch up.||
2367|156|B|||
2367|157|R|STORAGE:  Store at room temperature. Keep all medications away||
2367|158|R|from children and pets.||
2367|159|R|   Do not flush medications down the toilet or pour them into a||
2367|160|R|drain unless instructed to do so. Properly discard this product||
2367|161|R|when it is expired or no longer needed. Consult your pharmacist||
2367|162|R|or local waste disposal company.||
2367|163|B|||
2367|164|A|Information last revised September 2025.||
2367|165|A|Copyright(c) 2025 First Databank, Inc.||
2367|166|B|||
2368|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2368|002|Z|does NOT have all possible information about this product. This||
2368|003|Z|information does not assure that this product is safe, effective,||
2368|004|Z|or appropriate for you. This information is not individual||
2368|005|Z|medical advice and does not substitute for the advice of your||
2368|006|Z|health care professional. Always ask your health care||
2368|007|Z|professional for complete information about this product and your||
2368|008|Z|specific health needs.||
2368|009|B|||
2368|010|T|AVACOPAN - ORAL||
2368|011|F|(A-va-KOE-pan)||
2368|012|B|||
2368|013|C|COMMON BRAND NAME(S): Tavneos||
2368|014|B|||
2368|015|U|USES:  This medication is used to treat a certain type of blood||
2368|016|U|vessel disease: anti-neutrophil cytoplasmic autoantibody||
2368|017|U|(ANCA)-associated vasculitis. It works by blocking the immune||
2368|018|U|system from damaging the blood vessels.||
2368|019|B|||
2368|020|H|HOW TO USE:  Read the Medication Guide provided by your||
2368|021|H|pharmacist before you start taking avacopan and each time you get||
2368|022|H|a refill. If you have any questions, ask your doctor or||
2368|023|H|pharmacist.||
2368|024|H|   Take this medication by mouth with food as directed by your||
2368|025|H|doctor, usually twice daily. Swallow the capsules whole. Do not||
2368|026|H|chew, crush, or open the capsules.||
2368|027|H|   The dosage is based on your medical condition, response to||
2368|028|H|treatment, and other medications you may be taking. Be sure to||
2368|029|H|tell your doctor and pharmacist about all the products you use||
2368|030|H|(including prescription drugs, nonprescription drugs, and herbal||
2368|031|H|products).||
2368|032|H|   Do not increase your dose or use this drug more often or for||
2368|033|H|longer than prescribed. Your condition will not improve any||
2368|034|H|faster, and your risk of side effects will increase.||
2368|035|H|   Use this medication regularly to get the most benefit from it.||
2368|036|H|To help you remember, take it at the same times each day.||
2368|037|H|   Tell your doctor if your condition does not get better or it||
2368|038|H|gets worse.||
2368|039|B|||
2368|040|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, dizziness,||
2368|041|S|or tiredness may occur. If any of these effects last or get||
2368|042|S|worse, tell your doctor or pharmacist promptly.||
2368|043|S|   Remember that this medication has been prescribed because your||
2368|044|S|doctor has judged that the benefit to you is greater than the||
2368|045|S|risk of side effects. Many people using this medication do not||
2368|046|S|have serious side effects.||
2368|047|S|   This medication may raise your blood pressure. Check your||
2368|048|S|blood pressure regularly and tell your doctor if the results are||
2368|049|S|high.||
2368|050|S|   Tell your doctor right away if you have any serious side||
2368|051|S|effects, including: signs of liver disease (such as||
2368|052|S|nausea/vomiting that doesn't stop, loss of appetite,||
2368|053|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2368|054|S|of kidney problems (such as change in the amount of urine),||
2368|055|S|numb/tingling skin.||
2368|056|S|   Severe (possibly fatal) infections can occur in people taking||
2368|057|S|avacopan. Tell your doctor right away if you have any symptoms of||
2368|058|S|an infection (such as sore throat that doesn't go away, fever,||
2368|059|S|cough, shortness of breath, painful urination).||
2368|060|S|   Avacopan can commonly cause a rash that is usually not||
2368|061|S|serious. However, you may not be able to tell it apart from a||
2368|062|S|rare rash that could be a sign of a severe reaction. Get medical||
2368|063|S|help right away if you develop any rash.||
2368|064|S|   A very serious allergic reaction to this drug is rare.||
2368|065|S|However, get medical help right away if you notice any symptoms||
2368|066|S|of a serious allergic reaction, including: rash, itching/swelling||
2368|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2368|068|S|breathing.||
2368|069|S|   This is not a complete list of possible side effects. If you||
2368|070|S|notice other effects not listed above, contact your doctor or||
2368|071|S|pharmacist.||
2368|072|S|   In the US -||
2368|073|S|   Call your doctor for medical advice about side effects. You||
2368|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2368|075|S|www.fda.gov/medwatch.||
2368|076|S|   In Canada - Call your doctor for medical advice about side||
2368|077|S|effects. You may report side effects to Health Canada at||
2368|078|S|1-866-234-2345.||
2368|079|B|||
2368|080|P|PRECAUTIONS:  Before taking avacopan, tell your doctor or||
2368|081|P|pharmacist if you are allergic to it; or if you have any other||
2368|082|P|allergies. This product may contain inactive ingredients, which||
2368|083|P|can cause allergic reactions or other problems. Talk to your||
2368|084|P|pharmacist for more details.||
2368|085|P|   Before using this medication, tell your doctor or pharmacist||
2368|086|P|your medical history, especially of: liver problems (such as||
2368|087|P|hepatitis B), current/recent infections (such as tuberculosis).||
2368|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2368|089|P|can make you more dizzy. Do not drive, use machinery, or do||
2368|090|P|anything that needs alertness until you can do it safely. Limit||
2368|091|P|alcoholic beverages. Talk to your doctor if you are using||
2368|092|P|marijuana (cannabis).||
2368|093|P|   Before having surgery, tell your doctor or dentist about all||
2368|094|P|the products you use (including prescription drugs,||
2368|095|P|nonprescription drugs, and herbal products).||
2368|096|P|   During pregnancy, this medication should be used only when||
2368|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
2368|098|P|   It is unknown if this drug passes into breast milk. Consult||
2368|099|P|your doctor before breastfeeding.||
2368|100|B|||
2368|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2368|102|I|medications work or increase your risk for serious side effects.||
2368|103|I|This document does not contain all possible drug interactions.||
2368|104|I|Keep a list of all the products you use (including||
2368|105|I|prescription/nonprescription drugs and herbal products) and share||
2368|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
2368|107|I|the dosage of any medicines without your doctor's approval.||
2368|108|I|   Other medications can affect the removal of avacopan from your||
2368|109|I|body, which may affect how avacopan works. Examples include||
2368|110|I|rifamycins (such as rifampin), certain drugs used to treat||
2368|111|I|seizures (such as carbamazepine, phenytoin), among others.||
2368|112|I|   This medication can slow down the removal of other medications||
2368|113|I|from your body, which may affect how they work. Examples of||
2368|114|I|affected drugs include flibanserin, lomitapide, among others.||
2368|115|B|||
2368|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2368|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2368|118|O|poison control center right away. US residents can call||
2368|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2368|120|B|||
2368|121|N|NOTES:  Do not share this medication with others.||
2368|122|N|   Lab and/or medical tests (such as liver/kidney function,||
2368|123|N|hepatitis B screening) should be done before you start taking||
2368|124|N|this medication and while you are taking it. Keep all medical and||
2368|125|N|lab appointments. Consult your doctor for more details.||
2368|126|B|||
2368|127|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2368|128|D|next dose at the regular time. Do not double the dose to catch||
2368|129|D|up.||
2368|130|B|||
2368|131|R|STORAGE:  Store at room temperature away from light and moisture.||
2368|132|R|Do not store in the bathroom. Keep all medications away from||
2368|133|R|children and pets.||
2368|134|R|   Do not flush medications down the toilet or pour them into a||
2368|135|R|drain unless instructed to do so. Properly discard this product||
2368|136|R|when it is expired or no longer needed. Consult your pharmacist||
2368|137|R|or local waste disposal company.||
2368|138|B|||
2368|139|A|Information last revised March 2025.||
2368|140|A|Copyright(c) 2025 First Databank, Inc.||
2368|141|B|||
2369|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2369|002|Z|does NOT have all possible information about this product. This||
2369|003|Z|information does not assure that this product is safe, effective,||
2369|004|Z|or appropriate for you. This information is not individual||
2369|005|Z|medical advice and does not substitute for the advice of your||
2369|006|Z|health care professional. Always ask your health care||
2369|007|Z|professional for complete information about this product and your||
2369|008|Z|specific health needs.||
2369|009|B|||
2369|010|T|LONAPEGSOMATROPIN - SUBCUTANEOUS INJECTION||
2369|011|F|(LOE-na-peg-SOE-ma-TROE-pin)||
2369|012|B|||
2369|013|C|COMMON BRAND NAME(S): Skytrofa||
2369|014|B|||
2369|015|U|USES:  This medication is used to treat certain conditions||
2369|016|U|(growth hormone deficiency, growth failure) in people who do not||
2369|017|U|make enough growth hormone. Growth hormone is normally produced||
2369|018|U|in the brain by a certain gland (pituitary gland) and has various||
2369|019|U|effects on development in the body. A lack of growth hormone in||
2369|020|U|children results in slowed growth and short height for the||
2369|021|U|child's age. A lack of growth hormone in adults may lead to an||
2369|022|U|increase in body fat. Lonapegsomatropin works by providing more||
2369|023|U|growth hormone, which may help the long bones (such as the arms||
2369|024|U|and legs) grow longer and help reduce body fat in adults.||
2369|025|B|||
2369|026|H|HOW TO USE:  Read the Instructions for Use if available from your||
2369|027|H|pharmacist before you start using lonapegsomatropin and each time||
2369|028|H|you get a refill. Ask your health care professional how to||
2369|029|H|prepare and use this medication. If you have any questions, ask||
2369|030|H|your doctor or pharmacist.||
2369|031|H|   Inject this medication under the skin as directed by your||
2369|032|H|doctor, usually once weekly. The injection is given in the||
2369|033|H|stomach (abdomen), thighs, or buttocks. The dosage is based on||
2369|034|H|your medical condition, age, and response to treatment.||
2369|035|H|Children's dosage is also based on weight.||
2369|036|H|   Take the medication out of the refrigerator 15 minutes before||
2369|037|H|you inject it to allow it to reach room temperature. Do not warm||
2369|038|H|up this medication any other way (for example, do not heat it in||
2369|039|H|the microwave or place it in hot water). After mixing the||
2369|040|H|medication as directed, check this product for particles or||
2369|041|H|discoloration. If either is present, do not use the liquid.||
2369|042|H|Before injecting each dose, clean the skin you are going to||
2369|043|H|inject into (the injection site) with rubbing alcohol. Change the||
2369|044|H|injection site each time to lessen injury under the skin. To||
2369|045|H|lessen bruising, do not rub the injection site after a shot.||
2369|046|H|Learn how to store and discard medical supplies safely.||
2369|047|H|   This medication is injected with a device made to help you use||
2369|048|H|it properly. Do not share your device with another person, even||
2369|049|H|if the needle is changed. You may give other people a serious||
2369|050|H|infection, or get a serious infection from them.||
2369|051|H|   Use this medication regularly to get the most benefit from it.||
2369|052|H|To help you remember, mark your calendar with a reminder.||
2369|053|B|||
2369|054|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, abdominal pain, or||
2369|055|S|joint pain may occur. If any of these effects last or get worse,||
2369|056|S|tell your doctor or pharmacist promptly.||
2369|057|S|   Remember that this medication has been prescribed because your||
2369|058|S|doctor has judged that the benefit to you is greater than the||
2369|059|S|risk of side effects. Many people using this medication do not||
2369|060|S|have serious side effects.||
2369|061|S|   Tell your doctor right away if you have any serious side||
2369|062|S|effects, including: development of a limp, hip/knee pain,||
2369|063|S|numbness/tingling, increased thirst/frequent urination, swelling||
2369|064|S|hands/ankles/feet, nausea/vomiting that doesn't stop, severe||
2369|065|S|stomach/abdominal pain that doesn't stop, signs of bleeding (such||
2369|066|S|as nosebleeds, small red or purple spots on the skin), symptoms||
2369|067|S|of thyroid problems (such as cold intolerance, unexplained||
2369|068|S|increased weight).||
2369|069|S|   Get medical help right away if you have any very serious side||
2369|070|S|effects, including: seizure.||
2369|071|S|   Lonapegsomatropin may increase your risk of getting a new||
2369|072|S|tumor or cancer. Children who have had brain/head radiation||
2369|073|S|treatment for cancer should be monitored for new tumors/cancers.||
2369|074|S|Tell your doctor right away if you or a caregiver notice symptoms||
2369|075|S|such as unusual changes in behavior, vision problems/changes,||
2369|076|S|severe headache, changes in skin color, or change in the||
2369|077|S|appearance or size of a mole. Talk with your doctor for details||
2369|078|S|and to discuss the risks and benefits of this medication.||
2369|079|S|   A very serious allergic reaction to this drug is rare.||
2369|080|S|However, get medical help right away if you notice any symptoms||
2369|081|S|of a serious allergic reaction, including: rash, itching/swelling||
2369|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2369|083|S|breathing.||
2369|084|S|   This is not a complete list of possible side effects. If you||
2369|085|S|notice other effects not listed above, contact your doctor or||
2369|086|S|pharmacist.||
2369|087|S|   In the US -||
2369|088|S|   Call your doctor for medical advice about side effects. You||
2369|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2369|090|S|www.fda.gov/medwatch.||
2369|091|S|   In Canada - Call your doctor for medical advice about side||
2369|092|S|effects. You may report side effects to Health Canada at||
2369|093|S|1-866-234-2345.||
2369|094|B|||
2369|095|P|PRECAUTIONS:  See also Side Effects section.||
2369|096|P|   Before using lonapegsomatropin, tell your doctor or pharmacist||
2369|097|P|if you are allergic to it; or to somatropin products; or if you||
2369|098|P|have any other allergies. This product may contain inactive||
2369|099|P|ingredients, which can cause allergic reactions or other||
2369|100|P|problems. Talk to your pharmacist for more details.||
2369|101|P|   Before using this medication, tell your doctor or pharmacist||
2369|102|P|your medical history, especially of: adrenal gland problems, eye||
2369|103|P|problems (such as diabetic retinopathy), recent major||
2369|104|P|surgery/injury, diabetes or family history of diabetes, obesity,||
2369|105|P|kidney disease, cancer (especially of the head/neck), thyroid||
2369|106|P|problems, a certain back problem (scoliosis), Prader-Willi||
2369|107|P|syndrome.||
2369|108|P|   If you have diabetes, this drug may increase your blood sugar.||
2369|109|P|Check your blood sugar regularly as directed and share the||
2369|110|P|results with your doctor. Tell your doctor right away if you have||
2369|111|P|symptoms of high blood sugar such as increased thirst/urination.||
2369|112|P|Your doctor may need to adjust your diabetes medication, exercise||
2369|113|P|program, or diet.||
2369|114|P|   Before having surgery, tell your doctor or dentist about all||
2369|115|P|the products you use (including prescription drugs,||
2369|116|P|nonprescription drugs, and herbal products).||
2369|117|P|   During pregnancy, this medication should be used only when||
2369|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
2369|119|P|   It is unknown if this drug passes into breast milk. Consult||
2369|120|P|your doctor before breastfeeding.||
2369|121|B|||
2369|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2369|123|I|medications work or increase your risk for serious side effects.||
2369|124|I|This document does not contain all possible drug interactions.||
2369|125|I|Keep a list of all the products you use (including||
2369|126|I|prescription/nonprescription drugs and herbal products) and share||
2369|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
2369|128|I|the dosage of any medicines without your doctor's approval.||
2369|129|I|   Lonapegsomatropin is very similar to somatropin. Do not use||
2369|130|I|medications containing somatropin while using lonapegsomatropin.||
2369|131|B|||
2369|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2369|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2369|134|O|poison control center right away. US residents can call||
2369|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2369|136|B|||
2369|137|N|NOTES:  Do not share this medication with others.||
2369|138|N|   Lab and/or medical tests (such as eye exam, thyroid function,||
2369|139|N|blood sugar, parathyroid hormone, cortisol level) may be done||
2369|140|N|while you are using this medication. Keep all medical and lab||
2369|141|N|appointments.||
2369|142|B|||
2369|143|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2369|144|D|If it is more than 2 days after the missed dose, skip the missed||
2369|145|D|dose. Use your next dose on the regular scheduled day. Do not||
2369|146|D|double the dose to catch up. If you decide to change the regular||
2369|147|D|scheduled day, make sure to wait at least 5 days between the last||
2369|148|D|dose and the new dosing day.||
2369|149|D|   To avoid missed doses, this medication can be used 2 days||
2369|150|D|before or 2 days after the scheduled dosing day.||
2369|151|B|||
2369|152|R|STORAGE:  Store the cartridges in the refrigerator. Do not||
2369|153|R|freeze. Keep the cartridges in the original carton to protect||
2369|154|R|from light. This medication may also be stored at room||
2369|155|R|temperature and put back in the refrigerator if needed. Discard||
2369|156|R|medication 6 months after first removing from refrigerator. Keep||
2369|157|R|all medications away from children and pets.||
2369|158|R|   Do not flush medications down the toilet or pour them into a||
2369|159|R|drain unless instructed to do so. Properly discard this product||
2369|160|R|when it is expired or no longer needed. Consult your pharmacist||
2369|161|R|or local waste disposal company.||
2369|162|B|||
2369|163|A|Information last revised July 2025.||
2369|164|A|Copyright(c) 2025 First Databank, Inc.||
2369|165|B|||
2370|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2370|002|Z|does NOT have all possible information about this product. This||
2370|003|Z|information does not assure that this product is safe, effective,||
2370|004|Z|or appropriate for you. This information is not individual||
2370|005|Z|medical advice and does not substitute for the advice of your||
2370|006|Z|health care professional. Always ask your health care||
2370|007|Z|professional for complete information about this product and your||
2370|008|Z|specific health needs.||
2370|009|B|||
2370|010|T|PRAMOXINE/HYDROCORTISONE/ZINC SUPPOSITORY - RECTAL||
2370|011|F|(pra-MOX-een/HYE-droe-KOR-ti-sone/zink)||
2370|012|B|||
2370|013|U|USES:  This combination medication is used to treat minor pain,||
2370|014|U|itching, swelling, and discomfort caused by hemorrhoids and other||
2370|015|U|problems of the anal area (such as anal fissures, itching) in||
2370|016|U|adults. This medication contains pramoxine, an anesthetic that||
2370|017|U|works by temporarily numbing the area. This product also contains||
2370|018|U|hydrocortisone, a corticosteroid that reduces redness, itching,||
2370|019|U|and swelling. This product also contains zinc that reduces||
2370|020|U|itching and discomfort.||
2370|021|B|||
2370|022|H|HOW TO USE:  Use this product as directed by your doctor, usually||
2370|023|H|in the morning and at bedtime, or after each bowel movement. The||
2370|024|H|dosage is based on your medical condition and response to||
2370|025|H|treatment. Use this medication regularly in order to get the most||
2370|026|H|benefit from it. To help you remember, use it at the same times||
2370|027|H|each day.||
2370|028|H|   Avoid handling the suppository for too long because it will||
2370|029|H|melt. Unwrap the suppository. You may moisten the tip with a few||
2370|030|H|drops of water. Lie down on your left side with your right knee||
2370|031|H|bent. Gently push the suppository, pointed end first, into the||
2370|032|H|rectum with your finger, deep enough so it does not slide back||
2370|033|H|out. Remain lying down for a few minutes. Avoid having a bowel||
2370|034|H|movement for at least an hour so the medication will have time to||
2370|035|H|work.||
2370|036|H|   Wash hands immediately after use.||
2370|037|H|   Do not use more of this product, use it more often, or keep||
2370|038|H|using it longer than prescribed by your doctor. If you have been||
2370|039|H|using this medication for a long time or in high doses, do not||
2370|040|H|suddenly stop using it without your doctor's approval. Some||
2370|041|H|conditions may become worse when this drug is suddenly stopped.||
2370|042|H|Your dose may need to be gradually decreased.||
2370|043|H|   Tell your doctor if your condition lasts or gets worse.||
2370|044|B|||
2370|045|S|SIDE EFFECTS:  Burning, or itching may occur. If any of these||
2370|046|S|effects last or worsen, tell your doctor or pharmacist promptly.||
2370|047|S|   Remember that this medication has been prescribed because your||
2370|048|S|doctor has judged that the benefit to you is greater than the||
2370|049|S|risk of side effects. Many people using this medication do not||
2370|050|S|have serious side effects.||
2370|051|S|   Tell your doctor right away if you have any serious side||
2370|052|S|effects, including: rectal bleeding, change in skin appearance||
2370|053|S|(such as color, thickness), skin redness/tenderness/pus, signs of||
2370|054|S|infection (such as sore throat that doesn't go away, fever,||
2370|055|S|chills).||
2370|056|S|   Rarely, it is possible this medication will be absorbed into||
2370|057|S|the bloodstream. This can lead to side effects of too much||
2370|058|S|corticosteroid. These side effects are more likely in children||
2370|059|S|and people who use this medication for a long time. Tell your||
2370|060|S|doctor right away if any of the following side effects occur:||
2370|061|S|unusual/extreme tiredness, weight loss, headache, swelling||
2370|062|S|ankles/feet, increased thirst/urination, vision problems.||
2370|063|S|   A very serious allergic reaction to this drug is rare.||
2370|064|S|However, get medical help right away if you notice any symptoms||
2370|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2370|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2370|067|S|breathing.||
2370|068|S|   This is not a complete list of possible side effects. If you||
2370|069|S|notice other effects not listed above, contact your doctor or||
2370|070|S|pharmacist.||
2370|071|S|   In the US -||
2370|072|S|   Call your doctor for medical advice about side effects. You||
2370|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2370|074|S|www.fda.gov/medwatch.||
2370|075|S|   In Canada - Call your doctor for medical advice about side||
2370|076|S|effects. You may report side effects to Health Canada at||
2370|077|S|1-866-234-2345.||
2370|078|B|||
2370|079|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2370|080|P|pharmacist if you are allergic to pramoxine; or to||
2370|081|P|hydrocortisone; or if you have any other allergies. This product||
2370|082|P|may contain inactive ingredients, which can cause allergic||
2370|083|P|reactions or other problems. Talk to your pharmacist for more||
2370|084|P|details.||
2370|085|P|   Before using this medication, tell your doctor or pharmacist||
2370|086|P|your medical history, especially of: diabetes, eye problems,||
2370|087|P|infections (especially rectal sores/infections), liver disease,||
2370|088|P|stomach/intestinal problems.||
2370|089|P|   Rarely, using corticosteroid medications for a long time can||
2370|090|P|make it more difficult for your body to respond to physical||
2370|091|P|stress. Before having surgery or emergency treatment, or if you||
2370|092|P|get a serious illness/injury, tell your doctor or dentist that||
2370|093|P|you are using this medication or have used this medication within||
2370|094|P|the past few months.||
2370|095|P|   During pregnancy, this medication should be used only when||
2370|096|P|clearly needed. It should not be used for long periods of time or||
2370|097|P|in large amounts. Discuss the risks and benefits with your||
2370|098|P|doctor.||
2370|099|P|   It is unknown if this medication passes into breast milk.||
2370|100|P|Consult your doctor before breastfeeding.||
2370|101|B|||
2370|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2370|103|I|medications work or increase your risk for serious side effects.||
2370|104|I|This document does not contain all possible drug interactions.||
2370|105|I|Keep a list of all the products you use (including||
2370|106|I|prescription/nonprescription drugs and herbal products) and share||
2370|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
2370|108|I|the dosage of any medicines without your doctor's approval.||
2370|109|I|   A product that may interact with this drug is: desmopressin.||
2370|110|B|||
2370|111|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2370|112|O|has overdosed and has serious symptoms such as passing out or||
2370|113|O|trouble breathing, call 911. Otherwise, call a poison control||
2370|114|O|center right away. US residents can call 1-800-222-1222. Canada||
2370|115|O|residents can call 1-844-764-7669.||
2370|116|B|||
2370|117|N|NOTES:  Lab and/or medical tests (such as cortisol levels) may be||
2370|118|N|done while you are using this medication. Keep all medical and||
2370|119|N|lab appointments. Consult your doctor for more details.||
2370|120|N|   This medication has been prescribed for your current condition||
2370|121|N|only. Do not use it later for another condition unless told to do||
2370|122|N|so by your doctor. A different medication may be necessary in||
2370|123|N|that case.||
2370|124|B|||
2370|125|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2370|126|D|If it is near the time for the next dose, skip the missed dose.||
2370|127|D|Use your next dose at the regular time. Do not double the dose to||
2370|128|D|catch up.||
2370|129|B|||
2370|130|R|STORAGE:  Store at room temperature away from light and moisture.||
2370|131|R|Do not freeze. Keep all medications away from children and pets.||
2370|132|R|   Do not flush medications down the toilet or pour them into a||
2370|133|R|drain unless instructed to do so. Properly discard this product||
2370|134|R|when it is expired or no longer needed. Consult your pharmacist||
2370|135|R|or local waste disposal company.||
2370|136|B|||
2370|137|A|Information last revised May 2025.||
2370|138|A|Copyright(c) 2025 First Databank, Inc.||
2370|139|B|||
2371|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2371|002|Z|does NOT have all possible information about this product. This||
2371|003|Z|information does not assure that this product is safe, effective,||
2371|004|Z|or appropriate for you. This information is not individual||
2371|005|Z|medical advice and does not substitute for the advice of your||
2371|006|Z|health care professional. Always ask your health care||
2371|007|Z|professional for complete information about this product and your||
2371|008|Z|specific health needs.||
2371|009|B|||
2371|010|T|RABIES IMMUNE GLOBULIN - INJECTION||
2371|011|F|(RAY-beez i-MUNE-GLOB-ue-lin)||
2371|012|B|||
2371|013|C|COMMON BRAND NAME(S): Hyperrab, Imogam Rabies-HT, KedRab||
2371|014|B|||
2371|015|U|USES:  This medication is used to prevent a certain serious virus||
2371|016|U|infection, rabies, in people who have been exposed to this virus||
2371|017|U|under certain conditions (such as a bite wound or non-bite wound||
2371|018|U|by an infected animal). This medication is made from healthy||
2371|019|U|human blood that has high levels of certain defensive substances||
2371|020|U|(antibodies) that help fight rabies infection.||
2371|021|B|||
2371|022|H|HOW TO USE:  Part of the dose of this medication is given by||
2371|023|H|direct injection by a health care professional into the area of||
2371|024|H|the wound (bite or non-bite). The remainder of your dose is given||
2371|025|H|by injection into a muscle by a health care professional. It is||
2371|026|H|best to receive this medication as soon as possible after||
2371|027|H|exposure. If you wait too long after being exposed, the||
2371|028|H|medication may not work well. Your doctor may also recommend||
2371|029|H|vaccination after receiving this medication. Talk with your||
2371|030|H|doctor about the best treatment for you.||
2371|031|H|   The dosage is based on your medical condition and weight.||
2371|032|B|||
2371|033|S|SIDE EFFECTS:  Redness, pain, or tenderness at the injection site||
2371|034|S|may occur. Nausea, vomiting, diarrhea, dizziness, tiredness,||
2371|035|S|headache, or back/joint pain may also occur. If any of these||
2371|036|S|effects last or get worse, tell your doctor or pharmacist||
2371|037|S|promptly.||
2371|038|S|   Remember that this medication has been prescribed because your||
2371|039|S|doctor has judged that the benefit to you is greater than the||
2371|040|S|risk of side effects. Many people using this medication do not||
2371|041|S|have serious side effects.||
2371|042|S|   A very serious allergic reaction to this drug is rare.||
2371|043|S|However, get medical help right away if you notice any symptoms||
2371|044|S|of a serious allergic reaction, including: rash, itching/swelling||
2371|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2371|046|S|breathing.||
2371|047|S|   This is not a complete list of possible side effects. If you||
2371|048|S|notice other effects not listed above, contact your doctor or||
2371|049|S|pharmacist promptly.||
2371|050|S|   In the US -||
2371|051|S|   Call your doctor for medical advice about side effects. You||
2371|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2371|053|S|www.fda.gov/medwatch.||
2371|054|S|   In Canada - Call your doctor for medical advice about side||
2371|055|S|effects. You may report side effects to Health Canada at||
2371|056|S|1-866-234-2345.||
2371|057|B|||
2371|058|P|PRECAUTIONS:  Before receiving rabies immune globulin, tell your||
2371|059|P|doctor or pharmacist if you are allergic to it; or to other||
2371|060|P|immune globulin products; or if you have any other allergies.||
2371|061|P|This product may contain inactive ingredients, which can cause||
2371|062|P|allergic reactions or other problems. Talk to your pharmacist for||
2371|063|P|more details.||
2371|064|P|   Before using this medication, tell your doctor or pharmacist||
2371|065|P|your medical history, especially of: a certain immune system||
2371|066|P|problem (immunoglobulin A deficiency), vaccination/immunization||
2371|067|P|history.||
2371|068|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2371|069|P|can make you more dizzy. Do not drive, use machinery, or do||
2371|070|P|anything that needs alertness until you can do it safely. Limit||
2371|071|P|alcoholic beverages. Talk to your doctor if you are using||
2371|072|P|marijuana (cannabis).||
2371|073|P|   This medication is made from human blood. Even though the||
2371|074|P|blood is carefully tested, and this medication goes through a||
2371|075|P|special manufacturing process, there is an extremely small chance||
2371|076|P|that you may get infections (such as Creutzfeldt-Jakob||
2371|077|P|disease-CJD) from the medication. Consult your doctor or||
2371|078|P|pharmacist for more information.||
2371|079|P|   Tell your doctor of any recent or planned||
2371|080|P|immunizations/vaccinations. This medication may prevent a good||
2371|081|P|response to certain live viral vaccines (such as measles, mumps,||
2371|082|P|rubella, varicella). If you have recently received any of these||
2371|083|P|vaccines, your doctor may have you tested for a response or have||
2371|084|P|you vaccinated again later. If you plan on getting any of these||
2371|085|P|vaccines, your doctor will instruct you about the best time to||
2371|086|P|receive them so you get a good response.||
2371|087|P|   Before having surgery, tell your doctor or dentist about all||
2371|088|P|the products you use (including prescription drugs,||
2371|089|P|nonprescription drugs, and herbal products).||
2371|090|P|   During pregnancy, this medication should be used only when||
2371|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
2371|092|P|   It is unknown if this drug passes into breast milk. Consult||
2371|093|P|your doctor before breastfeeding.||
2371|094|B|||
2371|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2371|096|I|medications work or increase your risk for serious side effects.||
2371|097|I|This document does not contain all possible drug interactions.||
2371|098|I|Keep a list of all the products you use (including||
2371|099|I|prescription/nonprescription drugs and herbal products) and share||
2371|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
2371|101|I|the dosage of any medicines without your doctor's approval.||
2371|102|I|   This medication may interfere with certain lab tests (such as||
2371|103|I|Coomb's test), possibly causing false test results. Tell all lab||
2371|104|I|personnel and all your doctors and pharmacists that you use this||
2371|105|I|medication.||
2371|106|B|||
2371|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2371|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2371|109|O|poison control center right away. US residents can call||
2371|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2371|111|B|||
2371|112|N|NOTES:  Lab and/or medical tests (such as levels of antibody in||
2371|113|N|the blood) should be done while you are using this medication.||
2371|114|N|Keep all lab appointments. Consult your doctor for more details.||
2371|115|B|||
2371|116|D|MISSED DOSE:  Not applicable.||
2371|117|B|||
2371|118|R|STORAGE:  Not applicable. This medication is given in a hospital||
2371|119|R|or doctor's office and will not be stored at home.||
2371|120|B|||
2371|121|A|Information last revised May 2024.||
2371|122|A|Copyright(c) 2025 First Databank, Inc.||
2371|123|B|||
2372|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2372|002|Z|does NOT have all possible information about this product. This||
2372|003|Z|information does not assure that this product is safe, effective,||
2372|004|Z|or appropriate for you. This information is not individual||
2372|005|Z|medical advice and does not substitute for the advice of your||
2372|006|Z|health care professional. Always ask your health care||
2372|007|Z|professional for complete information about this product and your||
2372|008|Z|specific health needs.||
2372|009|B|||
2372|010|T|METOPROLOL SUCCINATE EXTENDED-RELEASE CAPSULE - ORAL||
2372|011|F|(MET-oh-PROE-lol SUX-i-nate)||
2372|012|B|||
2372|013|C|COMMON BRAND NAME(S): Kapspargo Sprinkle||
2372|014|B|||
2372|015|W|WARNING:  Do not stop taking this medication without consulting||
2372|016|W|your doctor. Some conditions may become worse when you suddenly||
2372|017|W|stop this drug. Some people who have suddenly stopped taking||
2372|018|W|similar drugs have had chest pain, heart attack, and irregular||
2372|019|W|heartbeat. If your doctor decides you should no longer use this||
2372|020|W|drug, your doctor may direct you to gradually decrease your dose||
2372|021|W|over 1 to 2 weeks.||
2372|022|W|   When gradually stopping this medication, it is recommended||
2372|023|W|that you temporarily limit physical activity to decrease strain||
2372|024|W|on the heart. Get medical help right away if you develop chest||
2372|025|W|pain/tightness/pressure, chest pain spreading to the||
2372|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
2372|027|W|fast/irregular heartbeat.||
2372|028|B|||
2372|029|U|USES:  This medication is a beta-blocker used to treat chest pain||
2372|030|U|(angina), heart failure, and high blood pressure. Lowering high||
2372|031|U|blood pressure helps prevent strokes, heart attacks, and kidney||
2372|032|U|problems.||
2372|033|U|   This drug works by blocking the action of certain natural||
2372|034|U|chemicals in your body (such as epinephrine) that affect the||
2372|035|U|heart and blood vessels. This lowers heart rate, blood pressure,||
2372|036|U|and strain on the heart.||
2372|037|B|||
2372|038|V|OTHER USES:  This section contains uses of this drug that are not||
2372|039|V|listed in the approved US professional labeling for the drug but||
2372|040|V|that may be prescribed by your health care professional. Use this||
2372|041|V|drug for a condition that is listed in this section only if it||
2372|042|V|has been so prescribed by your health care professional.||
2372|043|V|   This drug may also be used for irregular heartbeats or after||
2372|044|V|an acute heart attack to improve survival. It may also be used to||
2372|045|V|reduce the risk of migraine headaches.||
2372|046|B|||
2372|047|H|HOW TO USE:  See also Warning section.||
2372|048|H|   Take this medication by mouth as directed by your doctor,||
2372|049|H|usually once daily. This medication may be taken with or without||
2372|050|H|food.||
2372|051|H|   Swallow the capsule whole. Do not crush or chew||
2372|052|H|extended-release capsules. Doing so can release all of the drug||
2372|053|H|at once, increasing the risk of side effects.||
2372|054|H|   If you have trouble swallowing it whole, you may open the||
2372|055|H|capsule and sprinkle its contents on a spoonful of soft food||
2372|056|H|(such as applesauce, pudding, or yogurt). Swallow the drug/food||
2372|057|H|mixture without chewing. Use the mixture within 60 minutes. Do||
2372|058|H|not prepare a supply in advance. If you are giving this||
2372|059|H|medication through a tube into the stomach, ask your doctor or||
2372|060|H|pharmacist for specific directions. Avoid drinking alcoholic||
2372|061|H|beverages, since alcohol may interfere with the slow release of||
2372|062|H|this medication and increase the risk of side effects.||
2372|063|H|   To reduce your risk of side effects, your doctor may direct||
2372|064|H|you to start this medication at a low dose and gradually increase||
2372|065|H|your dose. Follow your doctor's instructions carefully. The||
2372|066|H|dosage is based on your medical condition and response to||
2372|067|H|treatment.||
2372|068|H|   Use this medication regularly to get the most benefit from it.||
2372|069|H|To help you remember, take it at the same time each day. Do not||
2372|070|H|suddenly stop taking this medication without consulting your||
2372|071|H|doctor. Your condition may become worse when the drug is suddenly||
2372|072|H|stopped.||
2372|073|H|   For the treatment of high blood pressure, it may take several||
2372|074|H|weeks before you get the full benefit of this drug. Keep taking||
2372|075|H|this medication even if you feel well. Most people with high||
2372|076|H|blood pressure do not feel sick.||
2372|077|H|   To prevent chest pain, a second heart attack, or migraine||
2372|078|H|headaches, it is very important to take this medication regularly||
2372|079|H|as prescribed. This drug should not be used to treat chest pain||
2372|080|H|or migraines when they occur. Use other medications to relieve||
2372|081|H|sudden attacks as directed by your doctor (for example,||
2372|082|H|nitroglycerin tablets placed under the tongue for chest pain,||
2372|083|H|"triptan" drugs such as sumatriptan for migraines). Consult your||
2372|084|H|doctor or pharmacist for details.||
2372|085|H|   Tell your doctor if your condition does not get better or if||
2372|086|H|it gets worse (for example, your blood pressure readings remain||
2372|087|H|high or increase, your chest pain or migraines occur more often).||
2372|088|B|||
2372|089|S|SIDE EFFECTS:  See also Warning section.||
2372|090|S|   Drowsiness, dizziness, tiredness, diarrhea, and slow heartbeat||
2372|091|S|may occur. Decreased sexual ability has been reported rarely. If||
2372|092|S|any of these effects last or get worse, tell your doctor or||
2372|093|S|pharmacist promptly.||
2372|094|S|   To reduce the risk of dizziness and lightheadedness, get up||
2372|095|S|slowly when rising from a sitting or lying position.||
2372|096|S|   With some brands of this medication, an empty tablet shell may||
2372|097|S|appear in your stool. This is harmless.||
2372|098|S|   This drug may reduce blood flow to your hands and feet,||
2372|099|S|causing them to feel cold. Smoking may worsen this effect. Dress||
2372|100|S|warmly and avoid tobacco use.||
2372|101|S|   Remember that this medication has been prescribed because your||
2372|102|S|doctor has judged that the benefit to you is greater than the||
2372|103|S|risk of side effects. Many people using this medication do not||
2372|104|S|have serious side effects.||
2372|105|S|   Tell your doctor right away if you have any serious side||
2372|106|S|effects, including: very slow heartbeat, fainting, blue||
2372|107|S|fingers/toes, new or worsening symptoms of heart failure (such as||
2372|108|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
2372|109|S|unusual/sudden weight gain), mental/mood changes (such as||
2372|110|S|confusion, mood swings, depression).||
2372|111|S|   A very serious allergic reaction to this drug is rare.||
2372|112|S|However, get medical help right away if you notice any symptoms||
2372|113|S|of a serious allergic reaction, including: rash, itching/swelling||
2372|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2372|115|S|breathing.||
2372|116|S|   This is not a complete list of possible side effects. If you||
2372|117|S|notice other effects not listed above, contact your doctor or||
2372|118|S|pharmacist.||
2372|119|S|   In the US -||
2372|120|S|   Call your doctor for medical advice about side effects. You||
2372|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2372|122|S|www.fda.gov/medwatch.||
2372|123|S|   In Canada - Call your doctor for medical advice about side||
2372|124|S|effects. You may report side effects to Health Canada at||
2372|125|S|1-866-234-2345.||
2372|126|B|||
2372|127|P|PRECAUTIONS:  Before taking metoprolol, tell your doctor or||
2372|128|P|pharmacist if you are allergic to it; or to other beta-blockers||
2372|129|P|(such as atenolol, propranolol); or if you have any other||
2372|130|P|allergies. This product may contain inactive ingredients, which||
2372|131|P|can cause allergic reactions or other problems. Talk to your||
2372|132|P|pharmacist for more details.||
2372|133|P|   Before using this medication, tell your doctor or pharmacist||
2372|134|P|your medical history, especially of: certain types of heart||
2372|135|P|rhythm problems (such as a slow heartbeat, second- or||
2372|136|P|third-degree atrioventricular block, sick sinus syndrome),||
2372|137|P|breathing problems (such as asthma, chronic bronchitis,||
2372|138|P|emphysema), liver disease, serious allergic reactions, including||
2372|139|P|those needing treatment with epinephrine, blood circulation||
2372|140|P|problems (such as Raynaud's disease, peripheral vascular||
2372|141|P|disease), mental/mood disorders (such as depression), a certain||
2372|142|P|muscle disease (myasthenia gravis).||
2372|143|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2372|144|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2372|145|P|machinery, or do anything that needs alertness until you can do||
2372|146|P|it safely. Limit or avoid alcoholic beverages. Talk to your||
2372|147|P|doctor if you are using marijuana (cannabis).||
2372|148|P|   Before having surgery, tell your doctor or dentist about all||
2372|149|P|the products you use (including prescription drugs,||
2372|150|P|nonprescription drugs, and herbal products).||
2372|151|P|   This product may prevent the fast/pounding heartbeat you would||
2372|152|P|usually feel when your blood sugar level falls too low||
2372|153|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
2372|154|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
2372|155|P|blood sugar level, such as dizziness and sweating, are not||
2372|156|P|affected by this drug.||
2372|157|P|   If you have diabetes, this product may make it harder to||
2372|158|P|control your blood sugar levels. Check your blood sugar levels||
2372|159|P|regularly as directed by your doctor. Tell your doctor right away||
2372|160|P|if you have symptoms of high blood sugar such as increased||
2372|161|P|thirst/urination. Your doctor may need to adjust your diabetes||
2372|162|P|medication, exercise program, or diet.||
2372|163|P|   Children may be at greater risk for low blood sugar||
2372|164|P|(hypoglycemia) while using this drug, especially if they are||
2372|165|P|vomiting or not eating regularly. To help prevent low blood||
2372|166|P|sugar, make sure children eat regularly. If your child cannot eat||
2372|167|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
2372|168|P|as sweating, shaking), tell the doctor right away.||
2372|169|P|   During pregnancy, this medication should be used only when||
2372|170|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2372|171|P|benefits with your doctor.||
2372|172|P|   This drug passes into breast milk but is unlikely to harm a||
2372|173|P|nursing infant. Consult your doctor before breastfeeding.||
2372|174|B|||
2372|175|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2372|176|I|medications work or increase your risk for serious side effects.||
2372|177|I|This document does not contain all possible drug interactions.||
2372|178|I|Keep a list of all the products you use (including||
2372|179|I|prescription/nonprescription drugs and herbal products) and share||
2372|180|I|it with your doctor and pharmacist. Do not start, stop, or change||
2372|181|I|the dosage of any medicines without your doctor's approval.||
2372|182|I|   A product that may interact with this drug is: fingolimod.||
2372|183|I|   Other medications can affect the removal of metoprolol from||
2372|184|I|your body, which may affect how metoprolol works. Examples||
2372|185|I|include lumefantrine, propafenone, quinidine, SSRI||
2372|186|I|antidepressants (such as fluoxetine, paroxetine), St. John's||
2372|187|I|wort, among others.||
2372|188|I|   Some products have ingredients that could raise your heart||
2372|189|I|rate or blood pressure or worsen your heart failure. Tell your||
2372|190|I|pharmacist what products you are using, and ask how to use them||
2372|191|I|safely (especially cough-and-cold products, diet aids, or NSAIDs||
2372|192|I|such as ibuprofen/naproxen).||
2372|193|B|||
2372|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2372|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2372|196|O|poison control center right away. US residents can call||
2372|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2372|198|O|Symptoms of overdose may include: very slow heartbeat, severe||
2372|199|O|dizziness, severe weakness, fainting, trouble breathing.||
2372|200|B|||
2372|201|N|NOTES:  Do not share this medication with others.||
2372|202|N|   Talk with your doctor about lifestyle changes that may help||
2372|203|N|this medication work better (such as stress reduction programs,||
2372|204|N|exercise, and dietary changes).||
2372|205|N|   Have your blood pressure and pulse (heart rate) checked||
2372|206|N|regularly while taking this medication. Learn how to check your||
2372|207|N|own blood pressure and pulse at home, and share the results with||
2372|208|N|your doctor.||
2372|209|N|   Lab and/or medical tests (such as liver function) should be||
2372|210|N|done while you are taking this medication. Consult your doctor||
2372|211|N|for more details.||
2372|212|B|||
2372|213|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2372|214|D|remember. If it is near the time of the next dose, skip the||
2372|215|D|missed dose. Take your next dose at the regular time. Do not||
2372|216|D|double the dose to catch up.||
2372|217|B|||
2372|218|R|STORAGE:  Store at room temperature away from light and moisture.||
2372|219|R|Do not store in the bathroom. Keep all medications away from||
2372|220|R|children and pets.||
2372|221|R|   Do not flush medications down the toilet or pour them into a||
2372|222|R|drain unless instructed to do so. Properly discard this product||
2372|223|R|when it is expired or no longer needed. Consult your pharmacist||
2372|224|R|or local waste disposal company.||
2372|225|B|||
2372|226|M|MEDICAL ALERT:  Your condition can cause complications in a||
2372|227|M|medical emergency. For information about enrolling in MedicAlert,||
2372|228|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2372|229|B|||
2372|230|A|Information last revised January 2025.||
2372|231|A|Copyright(c) 2025 First Databank, Inc.||
2372|232|B|||
2373|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2373|002|Z|does NOT have all possible information about this product. This||
2373|003|Z|information does not assure that this product is safe, effective,||
2373|004|Z|or appropriate for you. This information is not individual||
2373|005|Z|medical advice and does not substitute for the advice of your||
2373|006|Z|health care professional. Always ask your health care||
2373|007|Z|professional for complete information about this product and your||
2373|008|Z|specific health needs.||
2373|009|B|||
2373|010|T|RANIBIZUMAB IMPLANT - INTRAOCULAR||
2373|011|F|(RA-ni-BIZ-ue-mab)||
2373|012|B|||
2373|013|C|COMMON BRAND NAME(S): Susvimo||
2373|014|B|||
2373|015|W|WARNING:  This medication implant is used to deliver ranibizumab||
2373|016|W|into the eye. The implant and the procedures to place and use it||
2373|017|W|properly may have an increased risk of serious side effects such||
2373|018|W|as eye infection and eye damage. Tell your doctor right away if||
2373|019|W|you have vision changes such as decreased vision, sensitivity to||
2373|020|W|light, or seeing flashing lights or a curtain or veil covering||
2373|021|W|part of your vision or an increase in moving spots or what looks||
2373|022|W|like spider webs. Also tell your doctor right away if you have||
2373|023|W|increasing eye pain, or a sudden feeling that something is in||
2373|024|W|your eye, bleeding or redness in the white of the eye, or if you||
2373|025|W|have eye discharge, or watering of the eye. Proper treatment may||
2373|026|W|require immediate medical or surgical treatment.||
2373|027|B|||
2373|028|U|USES:  This medication implant is used to treat certain serious||
2373|029|U|eye conditions (such as age-related macular degeneration,||
2373|030|U|diabetic macular edema, diabetic retinopathy). It is used by||
2373|031|U|people who have had at least 2 injections of ranibizumab or a||
2373|032|U|similar medication injected into the eye with good results.||
2373|033|U|Ranibizumab works by slowing the growth of abnormal new blood||
2373|034|U|vessels in the eye and decreasing leakage from these blood||
2373|035|U|vessels. This medication may help prevent decreased vision and||
2373|036|U|blindness.||
2373|037|B|||
2373|038|H|HOW TO USE:  Read the Medication Guide provided by your||
2373|039|H|pharmacist before you start using ranibizumab implant and each||
2373|040|H|time you get a refill. If you have any questions, ask your doctor||
2373|041|H|or pharmacist.||
2373|042|H|   This medication is an implant placed into the affected eye(s)||
2373|043|H|by a health care professional. The affected eye is numbed before||
2373|044|H|the procedure. Your eye will be monitored before and after||
2373|045|H|placement. Your implant device will be refilled as directed by||
2373|046|H|your doctor, usually every 6 to 9 months. To help prevent serious||
2373|047|H|side effects, carefully follow your doctor's instructions after||
2373|048|H|the implant is placed, after each refill procedure, and after the||
2373|049|H|implant is removed. Use any eye drops exactly as directed by your||
2373|050|H|doctor.||
2373|051|H|   After the implant is placed, keep your head above shoulder||
2373|052|H|level for the rest of the day. Sleep with your head on 3 or more||
2373|053|H|pillows during the day and night after the implant is inserted.||
2373|054|H|Do not remove the eye shield from your eye until you are told to||
2373|055|H|do so by your doctor. For at least 7 nights after the insertion,||
2373|056|H|wear the eye shield when sleeping. Do not push on or rub the eye,||
2373|057|H|or touch the implant area for 30 days after the insertion. Many||
2373|058|H|patients will need to wait a month after the implant procedure to||
2373|059|H|do strenuous activities, but ask your doctor what length of time||
2373|060|H|is safest in your case.||
2373|061|H|   After the refill procedure, do not push on the eye, rub the||
2373|062|H|eye, or touch the implant area for 7 days. If you miss a||
2373|063|H|scheduled refill, contact your health care provider right away to||
2373|064|H|schedule a new appointment.||
2373|065|H|   After implant removal, keep your head above shoulder level for||
2373|066|H|the rest of the day. Sleep with your head on 3 or more pillows||
2373|067|H|during the day and night after the implant is removed. Wear an||
2373|068|H|eye shield for at least 7 nights. Do not do strenuous activities||
2373|069|H|until 14 days after the implant removal.||
2373|070|H|   Your health care provider should give you an implant card||
2373|071|H|after you receive the implant. Keep the card in a safe place and||
2373|072|H|show it to all your health care provider(s). You may only receive||
2373|073|H|an MRI under very specific conditions if you have this implant.||
2373|074|H|   Tell your doctor if your condition does not get better or if||
2373|075|H|it gets worse.||
2373|076|B|||
2373|077|S|SIDE EFFECTS:  See also Warning section.||
2373|078|S|   Eye pain, blood, or redness on the white of the eye may occur.||
2373|079|S|If any of these effects last or get worse, tell your doctor or||
2373|080|S|pharmacist promptly.||
2373|081|S|   Remember that this medication device has been prescribed||
2373|082|S|because your doctor has judged that the benefit to you is greater||
2373|083|S|than the risk of side effects. Many people using this medication||
2373|084|S|device do not have serious side effects.||
2373|085|S|   Tell your doctor right away if you notice that the implant has||
2373|086|S|moved out of place.||
2373|087|S|   The medication in this device may sometimes increase the risk||
2373|088|S|of serious (possibly fatal) blood clots. This may lead to stroke,||
2373|089|S|heart attack, and other blood vessel problems. Get medical help||
2373|090|S|right away if you develop: symptoms of stroke (such as weakness||
2373|091|S|on one side of the body, trouble speaking, sudden vision changes,||
2373|092|S|confusion), symptoms of a heart attack (such as chest/jaw/left||
2373|093|S|arm pain, shortness of breath, unusual sweating).||
2373|094|S|   A very serious allergic reaction to this drug is rare.||
2373|095|S|However, get medical help right away if you notice any symptoms||
2373|096|S|of a serious allergic reaction, including: rash, itching/swelling||
2373|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2373|098|S|breathing.||
2373|099|S|   This is not a complete list of possible side effects. If you||
2373|100|S|notice other effects not listed above, contact your doctor or||
2373|101|S|pharmacist.||
2373|102|S|   In the US -||
2373|103|S|   Call your doctor for medical advice about side effects. You||
2373|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2373|105|S|www.fda.gov/medwatch.||
2373|106|S|   In Canada - Call your doctor for medical advice about side||
2373|107|S|effects. You may report side effects to Health Canada at||
2373|108|S|1-866-234-2345.||
2373|109|B|||
2373|110|P|PRECAUTIONS:  Before receiving ranibizumab implant, tell your||
2373|111|P|doctor or pharmacist if you are allergic to ranibizumab; or if||
2373|112|P|you have any other allergies. This product may contain inactive||
2373|113|P|ingredients, which can cause allergic reactions or other||
2373|114|P|problems. Talk to your pharmacist for more details.||
2373|115|P|   Before using this medication, tell your doctor or pharmacist||
2373|116|P|your medical history, especially of: current/recent eye||
2373|117|P|infection.||
2373|118|P|   Before having surgery, tell your doctor or dentist about all||
2373|119|P|the products you use (including prescription drugs,||
2373|120|P|nonprescription drugs, and herbal products).||
2373|121|P|   Do not drive, use machinery, or do anything that needs clear||
2373|122|P|vision until the eye shield can be removed and you can see.||
2373|123|P|   Avoid rubbing your eye or touching the implant area as much as||
2373|124|P|you can. If you have to rub or touch your eye, wash your hands||
2373|125|P|first.||
2373|126|P|   During pregnancy, this medication should be used only when||
2373|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
2373|128|P|   It is unknown if this drug passes into breast milk. However,||
2373|129|P|this medication is unlikely to pass into breast milk. Consult||
2373|130|P|your doctor before breastfeeding.||
2373|131|B|||
2373|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2373|133|I|medications work or increase your risk for serious side effects.||
2373|134|I|This document does not contain all possible drug interactions.||
2373|135|I|Keep a list of all the products you use (including||
2373|136|I|prescription/nonprescription drugs and herbal products) and share||
2373|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
2373|138|I|the dosage of any medicines without your doctor's approval.||
2373|139|B|||
2373|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2373|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2373|142|O|poison control center right away. US residents can call||
2373|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2373|144|B|||
2373|145|N|NOTES:  Medical tests (such as eye exams) should be done while||
2373|146|N|you are using this medication. Keep all medical appointments.||
2373|147|N|Consult your doctor for more details.||
2373|148|B|||
2373|149|D|MISSED DOSE:  It is important to get each dose of this medication||
2373|150|D|as scheduled. If you miss a scheduled refill, contact your health||
2373|151|D|care provider right away to schedule a new appointment.||
2373|152|B|||
2373|153|R|STORAGE:  Not applicable. The device placement, refill, and||
2373|154|R|removal procedures are done in a clinic or doctor's office. The||
2373|155|R|device and medication will not be stored at home.||
2373|156|B|||
2373|157|A|Information last revised May 2025.||
2373|158|A|Copyright(c) 2025 First Databank, Inc.||
2373|159|B|||
2374|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2374|002|Z|does NOT have all possible information about this product. This||
2374|003|Z|information does not assure that this product is safe, effective,||
2374|004|Z|or appropriate for you. This information is not individual||
2374|005|Z|medical advice and does not substitute for the advice of your||
2374|006|Z|health care professional. Always ask your health care||
2374|007|Z|professional for complete information about this product and your||
2374|008|Z|specific health needs.||
2374|009|B|||
2374|010|T|VARENICLINE - NASAL||
2374|011|F|(var-EN-i-kleen)||
2374|012|B|||
2374|013|C|COMMON BRAND NAME(S): Tyrvaya||
2374|014|B|||
2374|015|U|USES:  Varenicline is used to treat dry eyes. It works by||
2374|016|U|increasing the amount of tears you make.||
2374|017|B|||
2374|018|H|HOW TO USE:  Read the Patient Information Leaflet and||
2374|019|H|Instructions for Use if available from your pharmacist before you||
2374|020|H|start using varenicline and each time you get a refill. Follow||
2374|021|H|the illustrated directions for the proper use of this medication.||
2374|022|H|If you have any questions, ask your doctor or pharmacist.||
2374|023|H|   Follow the instructions to properly prime the bottle if you||
2374|024|H|are using it for the first time or if you have not used it for||
2374|025|H|more than 5 days. Do not shake the bottle. Before using, blow||
2374|026|H|your nose to clear your nostrils. Spray this medication in the||
2374|027|H|nose as directed by your doctor, usually one spray in each||
2374|028|H|nostril, 2 times a day about 12 hours apart.||
2374|029|H|   To use the spray, remove the protective cap and clip. Tilt||
2374|030|H|your head back slightly, and keeping the bottle upright,||
2374|031|H|carefully insert the nasal applicator into the nostril. Do not||
2374|032|H|spray directly onto the middle wall of your nose (nasal septum).||
2374|033|H|Breathe in gently while pressing down firmly on the pump to||
2374|034|H|deliver one spray. Repeat in the other nostril. Wipe the||
2374|035|H|applicator tip and replace the plastic cap and clip.||
2374|036|H|   Use this medication regularly to get the most benefit from it.||
2374|037|H|To help you remember, use it at the same times each day. Do not||
2374|038|H|increase your dose or use this drug more often or for longer than||
2374|039|H|prescribed. Your condition will not improve any faster, and your||
2374|040|H|risk of side effects will increase.||
2374|041|H|   Tell your doctor if your condition lasts or gets worse.||
2374|042|B|||
2374|043|S|SIDE EFFECTS:  Sneezing, coughing, or throat/nose irritation may||
2374|044|S|occur. If any of these effects last or get worse, tell your||
2374|045|S|doctor or pharmacist promptly.||
2374|046|S|   Remember that this medication has been prescribed because your||
2374|047|S|doctor has judged that the benefit to you is greater than the||
2374|048|S|risk of side effects. Many people using this medication do not||
2374|049|S|have serious side effects.||
2374|050|S|   A very serious allergic reaction to this drug is rare.||
2374|051|S|However, get medical help right away if you notice any symptoms||
2374|052|S|of a serious allergic reaction, including: rash, itching/swelling||
2374|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2374|054|S|breathing.||
2374|055|S|   This is not a complete list of possible side effects. If you||
2374|056|S|notice other effects not listed above, contact your doctor or||
2374|057|S|pharmacist.||
2374|058|S|   In the US -||
2374|059|S|   Call your doctor for medical advice about side effects. You||
2374|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2374|061|S|www.fda.gov/medwatch.||
2374|062|S|   In Canada - Call your doctor for medical advice about side||
2374|063|S|effects. You may report side effects to Health Canada at||
2374|064|S|1-866-234-2345.||
2374|065|B|||
2374|066|P|PRECAUTIONS:  Before using varenicline, tell your doctor or||
2374|067|P|pharmacist if you are allergic to it; or if you have any other||
2374|068|P|allergies. This product may contain inactive ingredients, which||
2374|069|P|can cause allergic reactions or other problems. Talk to your||
2374|070|P|pharmacist for more details.||
2374|071|P|   Before using this medication, tell your doctor or pharmacist||
2374|072|P|your medical history.||
2374|073|P|   Before having surgery, tell your doctor or dentist about all||
2374|074|P|the products you use (including prescription drugs,||
2374|075|P|nonprescription drugs, and herbal products).||
2374|076|P|   During pregnancy, this medication should be used only when||
2374|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
2374|078|P|   It is unknown if this medication passes into breast milk.||
2374|079|P|Consult your doctor before breastfeeding.||
2374|080|B|||
2374|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2374|082|I|medications work or increase your risk for serious side effects.||
2374|083|I|This document does not contain all possible drug interactions.||
2374|084|I|Keep a list of all the products you use (including||
2374|085|I|prescription/nonprescription drugs and herbal products) and share||
2374|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
2374|087|I|the dosage of any medicines without your doctor's approval.||
2374|088|B|||
2374|089|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2374|090|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2374|091|O|poison control center right away. US residents can call||
2374|092|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2374|093|B|||
2374|094|N|NOTES:  Do not share this medication with others.||
2374|095|B|||
2374|096|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
2374|097|D|next dose at the regular time. Do not double the dose to catch||
2374|098|D|up.||
2374|099|B|||
2374|100|R|STORAGE:  Store at room temperature. Do not freeze. Once the||
2374|101|R|bottle is opened, this medication expires after 30 days. Keep all||
2374|102|R|medications away from children and pets.||
2374|103|R|   Do not flush medications down the toilet or pour them into a||
2374|104|R|drain unless instructed to do so. Properly discard this product||
2374|105|R|when it is expired or no longer needed. Consult your pharmacist||
2374|106|R|or local waste disposal company.||
2374|107|B|||
2374|108|A|Information last revised September 2024.||
2374|109|A|Copyright(c) 2025 First Databank, Inc.||
2374|110|B|||
2375|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2375|002|Z|does NOT have all possible information about this product. This||
2375|003|Z|information does not assure that this product is safe, effective,||
2375|004|Z|or appropriate for you. This information is not individual||
2375|005|Z|medical advice and does not substitute for the advice of your||
2375|006|Z|health care professional. Always ask your health care||
2375|007|Z|professional for complete information about this product and your||
2375|008|Z|specific health needs.||
2375|009|B|||
2375|010|T|PILOCARPINE SOLUTION (PRESBYOPIA) - OPHTHALMIC||
2375|011|F|(PYE-loe-KAR-peen)||
2375|012|B|||
2375|013|C|COMMON BRAND NAME(S): Qlosi, Vuity||
2375|014|B|||
2375|015|U|USES:  This medication is used to treat age-related||
2375|016|U|farsightedness (presbyopia). Pilocarpine works by causing the||
2375|017|U|pupil of the eye to shrink, which may help with seeing things up||
2375|018|U|close.||
2375|019|B|||
2375|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
2375|021|H|directed by your doctor, usually once or twice daily. Follow your||
2375|022|H|doctor's directions carefully.||
2375|023|H|   To apply eye drops, wash your hands first. To avoid||
2375|024|H|contamination, do not touch the dropper tip or let it touch your||
2375|025|H|eye or any other surface.||
2375|026|H|   If you are wearing contact lenses, remove them before using||
2375|027|H|eye drops. Wait at least 10 minutes before replacing your contact||
2375|028|H|lenses.||
2375|029|H|   Tilt your head back, look upward, and pull down the lower||
2375|030|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2375|031|H|and place one drop into the pouch. Look downward, gently close||
2375|032|H|your eyes, and place one finger at the corner of your eye (near||
2375|033|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2375|034|H|opening your eyes. This will prevent the medication from draining||
2375|035|H|out. Try not to blink or rub your eye. If directed to use this||
2375|036|H|medication in both eyes, repeat these steps for your other eye.||
2375|037|H|Do not rinse the dropper.||
2375|038|H|   If you are using another kind of eye medication (such as drops||
2375|039|H|or ointments), wait at least 5 minutes before applying other||
2375|040|H|medications. Use eye drops before eye ointments to allow the||
2375|041|H|drops to enter the eye.||
2375|042|H|   Wait several minutes for your vision to clear before driving||
2375|043|H|or operating machinery.||
2375|044|H|   Use this medication regularly to get the most benefit from it.||
2375|045|H|To help you remember, use it at the same time each day.||
2375|046|H|   Tell your doctor if your condition lasts or gets worse.||
2375|047|B|||
2375|048|S|SIDE EFFECTS:  Temporary irritation of the eye, temporary blurred||
2375|049|S|vision, eye redness, poor vision in dim light, or headache may||
2375|050|S|occur. If any of these effects last or get worse, tell your||
2375|051|S|doctor or pharmacist promptly.||
2375|052|S|   Remember that this medication has been prescribed because your||
2375|053|S|doctor has judged that the benefit to you is greater than the||
2375|054|S|risk of side effects. Many people using this medication do not||
2375|055|S|have serious side effects.||
2375|056|S|   Tell your doctor right away if you have any serious side||
2375|057|S|effects, including: eye pain, vision changes (such as seeing||
2375|058|S|floaters/flashes of light).||
2375|059|S|   A very serious allergic reaction to this drug is rare.||
2375|060|S|However, get medical help right away if you notice any symptoms||
2375|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2375|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2375|063|S|breathing.||
2375|064|S|   This is not a complete list of possible side effects. If you||
2375|065|S|notice other effects not listed above, contact your doctor or||
2375|066|S|pharmacist.||
2375|067|S|   In the US -||
2375|068|S|   Call your doctor for medical advice about side effects. You||
2375|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2375|070|S|www.fda.gov/medwatch.||
2375|071|S|   In Canada - Call your doctor for medical advice about side||
2375|072|S|effects. You may report side effects to Health Canada at||
2375|073|S|1-866-234-2345.||
2375|074|B|||
2375|075|P|PRECAUTIONS:  Before using pilocarpine, tell your doctor or||
2375|076|P|pharmacist if you are allergic to it; or if you have any other||
2375|077|P|allergies. This product may contain inactive ingredients, which||
2375|078|P|can cause allergic reactions or other problems. Talk to your||
2375|079|P|pharmacist for more details.||
2375|080|P|   Before using this medication, tell your doctor or pharmacist||
2375|081|P|your medical history, especially of: other eye problems (such as||
2375|082|P|iritis, detached retina).||
2375|083|P|   After you apply pilocarpine, your vision may become||
2375|084|P|temporarily blurred or unstable. Vision in dim light may be||
2375|085|P|affected. Do not drive (especially at night), use machinery, or||
2375|086|P|do anything that needs clear vision until you can do it safely.||
2375|087|P|   Before having surgery, tell your doctor or dentist about all||
2375|088|P|the products you use (including prescription drugs,||
2375|089|P|nonprescription drugs, and herbal products).||
2375|090|P|   During pregnancy, this medication should be used only when||
2375|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
2375|092|P|   It is unknown if this drug passes into breast milk. Consult||
2375|093|P|your doctor before breastfeeding.||
2375|094|B|||
2375|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2375|096|I|medications work or increase your risk for serious side effects.||
2375|097|I|This document does not contain all possible drug interactions.||
2375|098|I|Keep a list of all the products you use (including||
2375|099|I|prescription/nonprescription drugs and herbal products) and share||
2375|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
2375|101|I|the dosage of any medicines without your doctor's approval.||
2375|102|B|||
2375|103|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2375|104|O|has overdosed and has serious symptoms such as passing out or||
2375|105|O|trouble breathing, call 911. Otherwise, call a poison control||
2375|106|O|center right away. US residents can call 1-800-222-1222. Canada||
2375|107|O|residents can call 1-844-764-7669. Symptoms of overdose may||
2375|108|O|include: increased saliva or sweating, tremors, slow heartbeat,||
2375|109|O|dizziness.||
2375|110|B|||
2375|111|N|NOTES:  Do not share this medication with others.||
2375|112|N|   Lab and/or medical tests (such as eye exams) should be done||
2375|113|N|while you are using this medication. Keep all medical and lab||
2375|114|N|appointments. Consult your doctor for more details.||
2375|115|B|||
2375|116|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
2375|117|D|remember. If it is near the time of the next dose, skip the||
2375|118|D|missed dose. Use your next dose at the regular time. Do not||
2375|119|D|double the dose to catch up.||
2375|120|B|||
2375|121|R|STORAGE:  Different brands of this medication have different||
2375|122|R|storage needs. Check the product package for instructions on how||
2375|123|R|to store your brand, or ask your pharmacist. Keep all medications||
2375|124|R|away from children and pets.||
2375|125|R|   Do not flush medications down the toilet or pour them into a||
2375|126|R|drain unless instructed to do so. Properly discard this product||
2375|127|R|when it is expired or no longer needed. Consult your pharmacist||
2375|128|R|or local waste disposal company.||
2375|129|B|||
2375|130|A|Information last revised January 2025.||
2375|131|A|Copyright(c) 2025 First Databank, Inc.||
2375|132|B|||
2376|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2376|002|Z|does NOT have all possible information about this product. This||
2376|003|Z|information does not assure that this product is safe, effective,||
2376|004|Z|or appropriate for you. This information is not individual||
2376|005|Z|medical advice and does not substitute for the advice of your||
2376|006|Z|health care professional. Always ask your health care||
2376|007|Z|professional for complete information about this product and your||
2376|008|Z|specific health needs.||
2376|009|B|||
2376|010|T|ASCIMINIB - ORAL||
2376|011|F|(as-KIM-i-nib)||
2376|012|B|||
2376|013|C|COMMON BRAND NAME(S): Scemblix||
2376|014|B|||
2376|015|U|USES:  Asciminib is used to treat a certain type of cancer||
2376|016|U|(chronic myeloid leukemia-CML). Asciminib belongs to a class of||
2376|017|U|drugs known as kinase inhibitors. It works by slowing or stopping||
2376|018|U|the growth of cancer cells.||
2376|019|B|||
2376|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2376|021|H|from your pharmacist before you start taking asciminib and each||
2376|022|H|time you get a refill. If you have any questions, ask your doctor||
2376|023|H|or pharmacist.||
2376|024|H|   Take this medication by mouth without food as directed by your||
2376|025|H|doctor, usually once or twice a day. Do not eat food for at least||
2376|026|H|2 hours before and at least 1 hour after taking asciminib.||
2376|027|H|Swallow the tablets whole. Do not crush, chew, or break the||
2376|028|H|tablets.||
2376|029|H|   The dosage is based on your medical condition, response to||
2376|030|H|treatment, lab tests, and other medications you may be taking. Be||
2376|031|H|sure to tell your doctor and pharmacist about all the products||
2376|032|H|you use (including prescription drugs, nonprescription drugs, and||
2376|033|H|herbal products).||
2376|034|H|   Use this medication regularly to get the most benefit from it.||
2376|035|H|To help you remember, take it at the same time(s) each day. Do||
2376|036|H|not increase your dose or use this drug more often or for longer||
2376|037|H|than prescribed. Your condition will not improve any faster, and||
2376|038|H|your risk of serious side effects will increase.||
2376|039|H|   Since this drug can be absorbed through the skin and lungs and||
2376|040|H|may harm an unborn baby, women who are pregnant or who may become||
2376|041|H|pregnant should not handle this medication or breathe the dust||
2376|042|H|from the tablets.||
2376|043|B|||
2376|044|S|SIDE EFFECTS:  Muscle/bone pain, headache, tiredness, dizziness,||
2376|045|S|blurred vision, nausea, vomiting, or diarrhea may occur. If any||
2376|046|S|of these effects last or get worse, tell your doctor or||
2376|047|S|pharmacist promptly.||
2376|048|S|   People using this medication may have serious side effects.||
2376|049|S|However, you have been prescribed this drug because your doctor||
2376|050|S|has judged that the benefit to you is greater than the risk of||
2376|051|S|side effects. Careful monitoring by your doctor may decrease your||
2376|052|S|risk.||
2376|053|S|   This medication may raise your blood pressure. Check your||
2376|054|S|blood pressure regularly and tell your doctor if the results are||
2376|055|S|high. Your doctor may control your blood pressure with||
2376|056|S|medication.||
2376|057|S|   Tell your doctor right away if you have any serious side||
2376|058|S|effects, including: easy bruising/bleeding, signs of anemia (such||
2376|059|S|as severe tiredness, pale skin), signs of infection (such as sore||
2376|060|S|throat that doesn't go away, fever, chills), signs of disease of||
2376|061|S|the pancreas (such as severe stomach/abdominal pain which may||
2376|062|S|spread to the back, nausea/vomiting that doesn't go away).||
2376|063|S|   Get medical help right away if you have any very serious side||
2376|064|S|effects, including: symptoms of a heart attack (such as||
2376|065|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
2376|066|S|signs of a stroke (such as weakness on one side of the body,||
2376|067|S|trouble speaking, sudden vision changes, confusion), signs of||
2376|068|S|heart failure (such as sudden weight gain, swelling ankles/feet,||
2376|069|S|trouble breathing, unusual tiredness), fast/irregular heartbeat,||
2376|070|S|severe dizziness, fainting, pain/swelling/warmth in the||
2376|071|S|groin/calf.||
2376|072|S|   Asciminib can commonly cause a rash that is usually not||
2376|073|S|serious. However, you may not be able to tell it apart from a||
2376|074|S|rare rash that could be a sign of a severe reaction. Get medical||
2376|075|S|help right away if you develop any rash.||
2376|076|S|   A very serious allergic reaction to this drug is rare.||
2376|077|S|However, get medical help right away if you notice any symptoms||
2376|078|S|of a serious allergic reaction, including: rash, itching/swelling||
2376|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2376|080|S|breathing.||
2376|081|S|   This is not a complete list of possible side effects. If you||
2376|082|S|notice other effects not listed above, contact your doctor or||
2376|083|S|pharmacist.||
2376|084|S|   In the US -||
2376|085|S|   Call your doctor for medical advice about side effects. You||
2376|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2376|087|S|www.fda.gov/medwatch.||
2376|088|S|   In Canada - Call your doctor for medical advice about side||
2376|089|S|effects. You may report side effects to Health Canada at||
2376|090|S|1-866-234-2345.||
2376|091|B|||
2376|092|P|PRECAUTIONS:  Before taking asciminib, tell your doctor or||
2376|093|P|pharmacist if you are allergic to it; or if you have any other||
2376|094|P|allergies. This product may contain inactive ingredients, which||
2376|095|P|can cause allergic reactions or other problems. Talk to your||
2376|096|P|pharmacist for more details.||
2376|097|P|   Before using this medication, tell your doctor or pharmacist||
2376|098|P|your medical history, especially of: disease of the pancreas,||
2376|099|P|heart disease (such as heart attack, coronary artery disease,||
2376|100|P|heart failure), stroke, high blood pressure.||
2376|101|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
2376|102|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
2376|103|P|use machinery, or do anything that needs alertness or clear||
2376|104|P|vision until you can do it safely. Limit alcoholic beverages.||
2376|105|P|Talk to your doctor if you are using marijuana (cannabis).||
2376|106|P|   Asciminib can make you more likely to get infections or may||
2376|107|P|make current infections worse. Stay away from anyone who has an||
2376|108|P|infection that may easily spread (such as chickenpox, COVID-19,||
2376|109|P|measles, flu). Talk to your doctor if you have been exposed to an||
2376|110|P|infection or for more details.||
2376|111|P|   Tell your health care professional that you are using||
2376|112|P|asciminib before having any immunizations/vaccinations. Avoid||
2376|113|P|contact with people who have recently received live vaccines||
2376|114|P|(such as flu vaccine inhaled through the nose).||
2376|115|P|   To lower the chance of getting cut, bruised, or injured, use||
2376|116|P|caution with sharp objects like razors and nail cutters, and||
2376|117|P|avoid activities such as contact sports.||
2376|118|P|   Before having surgery, tell your doctor or dentist about all||
2376|119|P|the products you use (including prescription drugs,||
2376|120|P|nonprescription drugs, and herbal products).||
2376|121|P|   Since this drug can be absorbed through the skin and lungs and||
2376|122|P|may harm an unborn baby, women who are pregnant or who may become||
2376|123|P|pregnant should not handle this medication or breathe the dust||
2376|124|P|from the tablets.||
2376|125|P|   Tell your doctor if you are pregnant or plan to become||
2376|126|P|pregnant. You should not become pregnant while using asciminib.||
2376|127|P|Asciminib may harm an unborn baby. Your doctor should order a||
2376|128|P|pregnancy test before you start this medication. Ask about||
2376|129|P|reliable forms of birth control while using this medication and||
2376|130|P|for 1 week after the last dose. If you become pregnant, talk to||
2376|131|P|your doctor right away about the risks and benefits of this||
2376|132|P|medication.||
2376|133|P|   It is unknown if this drug passes into breast milk. Because of||
2376|134|P|the possible risk to the infant, breastfeeding is not recommended||
2376|135|P|while using this drug and for 1 week after the last dose. Consult||
2376|136|P|your doctor before breastfeeding.||
2376|137|B|||
2376|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2376|139|I|medications work or increase your risk for serious side effects.||
2376|140|I|This document does not contain all possible drug interactions.||
2376|141|I|Keep a list of all the products you use (including||
2376|142|I|prescription/nonprescription drugs and herbal products) and share||
2376|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
2376|144|I|the dosage of any medicines without your doctor's approval.||
2376|145|B|||
2376|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2376|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2376|148|O|poison control center right away. US residents can call||
2376|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2376|150|B|||
2376|151|N|NOTES:  Do not share this medication with others.||
2376|152|N|   Lab and/or medical tests (such as blood pressure, complete||
2376|153|N|blood count, lipase, amylase, heart function) should be done||
2376|154|N|while you are taking this medication. Keep all medical and lab||
2376|155|N|appointments. Consult your doctor for more details.||
2376|156|B|||
2376|157|D|MISSED DOSE:  If you are taking this medication once a day and||
2376|158|D|miss a dose, take it as soon as you remember. If it is more than||
2376|159|D|12 hours after the missed dose, skip the missed dose. Take your||
2376|160|D|next dose at the regular time. Do not double the dose to catch||
2376|161|D|up.||
2376|162|D|   If you are taking this medication twice a day and miss a dose,||
2376|163|D|take it as soon as you remember. If it is more than 6 hours after||
2376|164|D|the missed dose, skip the missed dose. Take your next dose at the||
2376|165|D|regular time. Do not double the dose to catch up..||
2376|166|B|||
2376|167|R|STORAGE:  Store in the original container at room temperature||
2376|168|R|away from light and moisture. Do not store in the bathroom. Keep||
2376|169|R|all medications away from children and pets.||
2376|170|R|   Do not flush medications down the toilet or pour them into a||
2376|171|R|drain unless instructed to do so. Properly discard this product||
2376|172|R|when it is expired or no longer needed. Consult your pharmacist||
2376|173|R|or local waste disposal company.||
2376|174|B|||
2376|175|M|MEDICAL ALERT:  Your condition can cause complications in a||
2376|176|M|medical emergency. For information about enrolling in MedicAlert,||
2376|177|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2376|178|B|||
2376|179|A|Information last revised October 2025.||
2376|180|A|Copyright(c) 2025 First Databank, Inc.||
2376|181|B|||
2377|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2377|002|Z|does NOT have all possible information about this product. This||
2377|003|Z|information does not assure that this product is safe, effective,||
2377|004|Z|or appropriate for you. This information is not individual||
2377|005|Z|medical advice and does not substitute for the advice of your||
2377|006|Z|health care professional. Always ask your health care||
2377|007|Z|professional for complete information about this product and your||
2377|008|Z|specific health needs.||
2377|009|B|||
2377|010|T|INFLIXIMAB - SUBCUTANEOUS INJECTION||
2377|011|F|(in-FLIX-i-mab)||
2377|012|B|||
2377|013|C|COMMON BRAND NAME(S): Zymfentra||
2377|014|B|||
2377|015|W|WARNING:  This medication can decrease your body's ability to||
2377|016|W|fight an infection. This effect can lead to very serious||
2377|017|W|(possibly fatal) infections (such as fungal infections, bacterial||
2377|018|W|infections including tuberculosis). You should have tuberculosis||
2377|019|W|(TB) skin tests before and during treatment with this medication.||
2377|020|W|Also tell your doctor your medical history, especially of||
2377|021|W|past/recent/current infections. You should also tell your doctor||
2377|022|W|if you have lived or traveled in areas where certain fungal||
2377|023|W|infections (such as coccidioidomycosis, histoplasmosis) are||
2377|024|W|common or if you have been near someone with tuberculosis. Areas||
2377|025|W|where these types of fungal infections are commonly found include||
2377|026|W|the Ohio and Mississippi River valleys and the southwestern||
2377|027|W|United States. See Side Effects section for infection symptoms to||
2377|028|W|watch out for, and get medical help right away if you have any of||
2377|029|W|these symptoms.||
2377|030|W|   The immune system also helps prevent and control cancer. There||
2377|031|W|is a very small risk (especially in children/teens/young adults)||
2377|032|W|of developing cancer (such as lymphoma, skin cancer) due to this||
2377|033|W|medication or due to your medical condition. A rare, mostly fatal||
2377|034|W|cancer (hepatosplenic T-cell lymphoma) has occurred in people||
2377|035|W|receiving this medication along with certain other drugs||
2377|036|W|(azathioprine or 6-mercaptopurine) to treat Crohn's disease or||
2377|037|W|ulcerative colitis. Talk to your doctor about the risks and||
2377|038|W|benefits of treatment. Tell your doctor right away if you have||
2377|039|W|symptoms such as unusual lumps/growths, swollen lymph nodes,||
2377|040|W|swollen or painful abdomen, unexplained weight loss, fever that||
2377|041|W|doesn't go away, or night sweats.||
2377|042|B|||
2377|043|U|USES:  This medication is used to treat certain bowel diseases||
2377|044|U|(Crohn's disease, ulcerative colitis). Some brands may also be||
2377|045|U|used to treat a certain type of arthritis (rheumatoid arthritis).||
2377|046|U|In these conditions, the body's defense system (immune system)||
2377|047|U|attacks healthy tissues. Infliximab works by blocking the actions||
2377|048|U|of a certain natural substance (tumor necrosis factor alpha) in||
2377|049|U|the body. This helps to decrease swelling (inflammation) and||
2377|050|U|weaken your immune system, which slows or stops the damage from||
2377|051|U|the disease.||
2377|052|U|   This monograph is about the following infliximab products:||
2377|053|U|infliximab, infliximab-dyyb.||
2377|054|B|||
2377|055|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2377|056|H|provided by your pharmacist before you start using infliximab and||
2377|057|H|each time you get a refill. Ask your health care professional how||
2377|058|H|to prepare and use this medication. If you have any questions,||
2377|059|H|ask your doctor or pharmacist.||
2377|060|H|   This medication is given by injection under the skin as||
2377|061|H|directed by your doctor, usually once every 2 weeks. The||
2377|062|H|injection is given in the abdomen (except for a 2-inch area||
2377|063|H|around your belly button), thigh, or upper arm. The dosage is||
2377|064|H|based on your medical condition and response to treatment.||
2377|065|H|   Take the medication out of the refrigerator at least 30||
2377|066|H|minutes before you inject it to allow it to reach room||
2377|067|H|temperature. Do not warm up this medication any other way (for||
2377|068|H|example, do not heat it in the microwave or place it in hot||
2377|069|H|water). Do not shake the medication. Before using, check this||
2377|070|H|product for particles or discoloration. If either is present, do||
2377|071|H|not use the liquid. Before injecting each dose, clean the skin||
2377|072|H|you are going to inject into (the injection site) with rubbing||
2377|073|H|alcohol. Change the injection site each time to lessen injury||
2377|074|H|under the skin. Do not inject into skin that is tender, damaged,||
2377|075|H|bruised, or scarred. To lessen bruising, do not rub the injection||
2377|076|H|site after a shot. Learn how to store and discard medical||
2377|077|H|supplies safely.||
2377|078|H|   Use this medication regularly to get the most benefit from it.||
2377|079|H|To help you remember, mark your calendar with a reminder.||
2377|080|H|   Tell your doctor if your condition does not get better or if||
2377|081|H|it gets worse.||
2377|082|B|||
2377|083|S|SIDE EFFECTS:  See also Warning section.||
2377|084|S|   Injection site redness, pain, itching, or swelling may occur.||
2377|085|S|Headache, upset stomach, back pain, diarrhea, tiredness, or||
2377|086|S|dizziness may also occur. If any of these effects last or get||
2377|087|S|worse, tell your doctor or pharmacist promptly.||
2377|088|S|   Remember that this medication has been prescribed because your||
2377|089|S|doctor has judged that the benefit to you is greater than the||
2377|090|S|risk of side effects. Many people using this medication do not||
2377|091|S|have serious side effects.||
2377|092|S|   Tell your doctor right away if you have any serious side||
2377|093|S|effects, including: joint/muscle pain, easy bruising/bleeding,||
2377|094|S|seizures, confusion, muscle weakness, numbness/tingling of||
2377|095|S|arms/legs, butterfly-shaped facial rash, pain/redness/swelling of||
2377|096|S|arms or legs, new or worsening symptoms of heart failure (such as||
2377|097|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
2377|098|S|unusual/sudden weight gain).||
2377|099|S|   Tell your doctor right away if you develop signs of infection||
2377|100|S|while using this drug, such as: cough/sore throat that doesn't go||
2377|101|S|away, fever, chills, night sweats, painful/frequent urination,||
2377|102|S|unusual vaginal discharge, white patches in the mouth (oral||
2377|103|S|thrush).||
2377|104|S|   This drug may rarely cause serious (possibly fatal) liver||
2377|105|S|disease. Get medical help right away if you have any symptoms of||
2377|106|S|liver damage, such as: unusual tiredness, nausea/vomiting that||
2377|107|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
2377|108|S|eyes/skin, dark urine.||
2377|109|S|   A very serious allergic reaction to this drug is rare.||
2377|110|S|However, get medical help right away if you notice any symptoms||
2377|111|S|of a serious allergic reaction, including: rash, itching/swelling||
2377|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2377|113|S|breathing.||
2377|114|S|   This is not a complete list of possible side effects. If you||
2377|115|S|notice other effects not listed above, contact your doctor or||
2377|116|S|pharmacist.||
2377|117|S|   In the US -||
2377|118|S|   Call your doctor for medical advice about side effects. You||
2377|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2377|120|S|www.fda.gov/medwatch.||
2377|121|S|   In Canada - Call your doctor for medical advice about side||
2377|122|S|effects. You may report side effects to Health Canada at||
2377|123|S|1-866-234-2345.||
2377|124|B|||
2377|125|P|PRECAUTIONS:  Before using infliximab, tell your doctor or||
2377|126|P|pharmacist if you are allergic to it; or if you have any other||
2377|127|P|allergies. This product may contain inactive ingredients, which||
2377|128|P|can cause allergic reactions or other problems. Talk to your||
2377|129|P|pharmacist for more details.||
2377|130|P|   Before using this medication, tell your doctor or pharmacist||
2377|131|P|your medical history, especially of: tuberculosis (previous||
2377|132|P|infection or positive skin test), past/recent/current infections||
2377|133|P|(such as cold sores, valley fever), heart disease (such as heart||
2377|134|P|failure), blood/bone marrow disorder (such as leukopenia,||
2377|135|P|thrombocytopenia), nervous system disorder (such as||
2377|136|P|numbness/tingling, seizures, multiple sclerosis), cancer (such as||
2377|137|P|breast cancer, skin cancer, lymphoma), a certain lung disorder||
2377|138|P|(chronic obstructive pulmonary disease-COPD), liver problems||
2377|139|P|(such as hepatitis B), light treatment for psoriasis||
2377|140|P|(phototherapy).||
2377|141|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2377|142|P|can make you more dizzy. Do not drive, use machinery, or do||
2377|143|P|anything that needs alertness until you can do it safely. Limit||
2377|144|P|alcoholic beverages. Talk to your doctor if you are using||
2377|145|P|marijuana (cannabis).||
2377|146|P|   Infliximab can make you more likely to get infections or may||
2377|147|P|make current infections worse. Stay away from anyone who has an||
2377|148|P|infection that may easily spread (such as chickenpox, COVID-19,||
2377|149|P|measles, flu). Talk to your doctor if you have been exposed to an||
2377|150|P|infection or for more details.||
2377|151|P|   Tell your doctor your vaccine history and ask if you need to||
2377|152|P|get any vaccines before starting treatment with this medication.||
2377|153|P|Tell your health care professional that you are using infliximab||
2377|154|P|before having any immunizations/vaccinations. Avoid contact with||
2377|155|P|people who have recently received live vaccines (such as flu||
2377|156|P|vaccine inhaled through the nose).||
2377|157|P|   Before having surgery, tell your doctor or dentist about all||
2377|158|P|the products you use (including prescription drugs,||
2377|159|P|nonprescription drugs, and herbal products).||
2377|160|P|   Older adults may be more sensitive to the side effects of this||
2377|161|P|drug, especially risk for infections.||
2377|162|P|   During pregnancy, this medication should be used only when||
2377|163|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2377|164|P|benefits with your doctor. Mothers who have used this medication||
2377|165|P|during pregnancy should ask a doctor about||
2377|166|P|immunizations/vaccinations for their newborn babies.||
2377|167|P|   This drug may pass into breast milk, but it is unlikely to||
2377|168|P|harm a nursing infant. Consult your doctor before breastfeeding.||
2377|169|B|||
2377|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2377|171|I|medications work or increase your risk for serious side effects.||
2377|172|I|This document does not contain all possible drug interactions.||
2377|173|I|Keep a list of all the products you use (including||
2377|174|I|prescription/nonprescription drugs and herbal products) and share||
2377|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
2377|176|I|the dosage of any medicines without your doctor's approval.||
2377|177|I|   Some products that may interact with this drug are: other||
2377|178|I|drugs that weaken the immune system/increase the risk of||
2377|179|I|infection (such as abatacept, anakinra), treatment with weakened||
2377|180|I|bacteria/viruses (such as live vaccines, BCG for bladder cancer).||
2377|181|B|||
2377|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2377|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2377|184|O|poison control center right away. US residents can call||
2377|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2377|186|B|||
2377|187|N|NOTES:  Do not share this medication with others.||
2377|188|N|   Lab and/or medical tests (such as complete blood count, liver||
2377|189|N|function, skin exams, Pap smear) should be done while you are||
2377|190|N|using this medication. Keep all medical and lab appointments.||
2377|191|N|Consult your doctor for more details.||
2377|192|B|||
2377|193|D|MISSED DOSE:  It is important to get each dose of this medication||
2377|194|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2377|195|D|right away for a new dosing schedule. Do not double the dose to||
2377|196|D|catch up.||
2377|197|B|||
2377|198|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2377|199|R|medication in the original packaging to protect from light. Some||
2377|200|R|brands of this medication may also be stored at room temperature||
2377|201|R|if needed. Check the product package for storage instructions or||
2377|202|R|ask your pharmacist. If the medication is stored at room||
2377|203|R|temperature, do not put it back in the refrigerator. Keep all||
2377|204|R|medications away from children and pets.||
2377|205|R|   Do not flush medications down the toilet or pour them into a||
2377|206|R|drain unless instructed to do so. Properly discard this product||
2377|207|R|when it is expired or no longer needed. Consult your pharmacist||
2377|208|R|or local waste disposal company.||
2377|209|B|||
2377|210|M|MEDICAL ALERT:  Your condition can cause complications in a||
2377|211|M|medical emergency. For information about enrolling in MedicAlert,||
2377|212|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2377|213|B|||
2377|214|A|Information last revised May 2025.||
2377|215|A|Copyright(c) 2025 First Databank, Inc.||
2377|216|B|||
2378|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2378|002|Z|does NOT have all possible information about this product. This||
2378|003|Z|information does not assure that this product is safe, effective,||
2378|004|Z|or appropriate for you. This information is not individual||
2378|005|Z|medical advice and does not substitute for the advice of your||
2378|006|Z|health care professional. Always ask your health care||
2378|007|Z|professional for complete information about this product and your||
2378|008|Z|specific health needs.||
2378|009|B|||
2378|010|T|ROPEGINTERFERON ALFA-2B - INJECTION||
2378|011|B|||
2378|012|C|COMMON BRAND NAME(S): Besremi||
2378|013|B|||
2378|014|W|WARNING:  This medication may rarely cause or worsen some serious||
2378|015|W|medical conditions, including mental/mood problems (such as||
2378|016|W|depression), autoimmune conditions (such as lupus, rheumatoid||
2378|017|W|arthritis), blood vessel problems (such as heart disease), or||
2378|018|W|infections. Careful monitoring by your doctor may decrease your||
2378|019|W|risk. Tell your doctor right away if you develop any serious||
2378|020|W|symptoms or side effects (see Side Effects section). Some side||
2378|021|W|effects may go away or lessen after stopping treatment with this||
2378|022|W|medication.||
2378|023|B|||
2378|024|U|USES:  Ropeginterferon alfa-2b is used to treat a certain type of||
2378|025|U|cancer (polycythemia vera). This medication is the same as a||
2378|026|U|protein that your body naturally produces (interferon). In the||
2378|027|U|body, it is thought to work by affecting cell function/growth and||
2378|028|U|the body's natural defenses (immune system) in many ways.||
2378|029|B|||
2378|030|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2378|031|H|provided by your pharmacist before you start using||
2378|032|H|ropeginterferon alfa-2b and each time you get a refill. If you||
2378|033|H|have any questions, ask your doctor or pharmacist.||
2378|034|H|   If you are using this medication at home, learn all||
2378|035|H|preparation and usage instructions from your health care||
2378|036|H|professional and the product package. Inject this medication||
2378|037|H|under the skin as directed by your doctor, usually once every 2||
2378|038|H|weeks. The injection is given in the abdomen or thigh. Do not||
2378|039|H|inject near the belly button or at the waistline. The dosage and||
2378|040|H|schedule are based on your medical condition, lab tests, and||
2378|041|H|response to treatment. If you are stable on this medication for||
2378|042|H|at least a year, your doctor may change your dosing schedule to a||
2378|043|H|longer time interval (such as every 4 weeks).||
2378|044|H|   For a more comfortable injection, take the medication out of||
2378|045|H|the refrigerator at least 15 to 30 minutes before you inject it||
2378|046|H|to allow it to reach room temperature. Do not warm up this||
2378|047|H|medication any other way (for example, do not heat it in the||
2378|048|H|microwave or place it in hot water). Before using, check this||
2378|049|H|product for particles or discoloration. If either is present, do||
2378|050|H|not use the liquid. Before injecting each dose, clean the skin||
2378|051|H|you are going to inject into (the injection site) with rubbing||
2378|052|H|alcohol. Change the injection site each time to lessen injury||
2378|053|H|under the skin. Do not inject into skin that is irritated, red,||
2378|054|H|bruised, infected, or scarred. To lessen bruising, do not rub the||
2378|055|H|injection site after a shot. Learn how to store and discard||
2378|056|H|medical supplies safely.||
2378|057|H|   Use this medication regularly to get the most benefit from it.||
2378|058|H|To help you remember, mark your calendar with a reminder.||
2378|059|H|   Drink plenty of fluids while using this medication unless your||
2378|060|H|doctor directs you otherwise.||
2378|061|B|||
2378|062|S|SIDE EFFECTS:  See also Warning section.||
2378|063|S|   Most people have flu-like symptoms such as headache,||
2378|064|S|tiredness, fever, chills, and muscle aches, but these usually||
2378|065|S|decrease after the first few weeks of treatment. You can lessen||
2378|066|S|these side effects by injecting this medicine at bedtime and||
2378|067|S|using fever reducers/pain relievers such as acetaminophen before||
2378|068|S|each dose. Ask your doctor or pharmacist for more information.||
2378|069|S|Nausea, vomiting, diarrhea, dry mouth, dry eyes, loss of||
2378|070|S|appetite, dizziness, drowsiness, trouble sleeping, or||
2378|071|S|redness/swelling at the injection site may also occur. If any of||
2378|072|S|these effects last or get worse, tell your doctor or pharmacist||
2378|073|S|promptly.||
2378|074|S|   Tooth and gum problems may sometimes occur during treatment.||
2378|075|S|Having a dry mouth can worsen this side effect. Prevent dry mouth||
2378|076|S|by drinking plenty of water or using a saliva substitute. Brush||
2378|077|S|your teeth well at least twice a day and have regular dental||
2378|078|S|exams. If you vomit, rinse your mouth afterward to lessen the||
2378|079|S|chance of tooth and gum problems.||
2378|080|S|   Temporary hair loss may occur. Normal hair growth should||
2378|081|S|return after treatment has ended.||
2378|082|S|   Remember that this medication has been prescribed because your||
2378|083|S|doctor has judged that the benefit to you is greater than the||
2378|084|S|risk of side effects. Many people using this medication do not||
2378|085|S|have serious side effects.||
2378|086|S|   Tell your doctor right away if you have any serious side||
2378|087|S|effects, including: easy bleeding/bruising, feeling too hot or||
2378|088|S|cold (more than others around you), gradual change in weight||
2378|089|S|(without a change in diet or exercise), unusually||
2378|090|S|slow/fast/pounding heartbeat, increased thirst/urination,||
2378|091|S|black/tarry stools, signs of liver problems (such as||
2378|092|S|nausea/vomiting that doesn't stop, loss of appetite,||
2378|093|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2378|094|S|numbness/tingling of arms/legs, menstrual changes (such as||
2378|095|S|absent/delayed/irregular periods).||
2378|096|S|   Get medical help right away if you have any very serious side||
2378|097|S|effects, including: chest pain, seizures, symptoms of a stroke||
2378|098|S|(such as weakness on one side of the body, trouble speaking,||
2378|099|S|confusion), vision changes (such as blurred vision, partial loss||
2378|100|S|of vision).||
2378|101|S|   This drug may cause serious mental/mood changes that may get||
2378|102|S|worse during treatment or after your last dose. Tell your doctor||
2378|103|S|right away if you have symptoms such as confusion, depression,||
2378|104|S|hallucinations, thoughts of suicide or hurting others, unusual||
2378|105|S|irritability, or aggressive behavior.||
2378|106|S|   This medication may lower your ability to fight infections.||
2378|107|S|This may make you more likely to get a serious (rarely fatal)||
2378|108|S|infection or make any infection you have worse. Tell your doctor||
2378|109|S|right away if you have any signs of infection (such as sore||
2378|110|S|throat that doesn't go away, fever, chills).||
2378|111|S|   A very serious allergic reaction to this drug is rare.||
2378|112|S|However, get medical help right away if you notice any symptoms||
2378|113|S|of a serious allergic reaction, including: rash, itching/swelling||
2378|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2378|115|S|breathing.||
2378|116|S|   This is not a complete list of possible side effects. If you||
2378|117|S|notice other effects not listed above, contact your doctor or||
2378|118|S|pharmacist.||
2378|119|S|   In the US -||
2378|120|S|   Call your doctor for medical advice about side effects. You||
2378|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2378|122|S|www.fda.gov/medwatch.||
2378|123|S|   In Canada - Call your doctor for medical advice about side||
2378|124|S|effects. You may report side effects to Health Canada at||
2378|125|S|1-866-234-2345.||
2378|126|B|||
2378|127|P|PRECAUTIONS:  See also Warning section.||
2378|128|P|   Before using ropeginterferon alfa-2b, tell your doctor or||
2378|129|P|pharmacist if you are allergic to it; or to polyethylene glycol||
2378|130|P|(PEG); or if you have any other allergies. This product may||
2378|131|P|contain inactive ingredients, which can cause allergic reactions||
2378|132|P|or other problems. Talk to your pharmacist for more details.||
2378|133|P|   Before using this medication, tell your doctor or pharmacist||
2378|134|P|your medical history, especially of: mental/mood disorders (such||
2378|135|P|as depression, psychosis, suicidal thoughts), autoimmune||
2378|136|P|disorders (such as rheumatoid arthritis, lupus, psoriasis),||
2378|137|P|bleeding/blood problems, diabetes, heart problems, high blood||
2378|138|P|pressure, intestinal problems (such as colitis), kidney problems,||
2378|139|P|liver problems (such as hepatitis), lung problems (such as||
2378|140|P|chronic obstructive pulmonary disease-COPD), organ transplant,||
2378|141|P|pancreatitis, high triglyceride levels, thyroid problems,||
2378|142|P|substance use disorder (such as overuse of or addiction to||
2378|143|P|drugs/alcohol).||
2378|144|P|   This medication can make you more likely to get infections or||
2378|145|P|may make current infections worse. Stay away from anyone who has||
2378|146|P|an infection that may easily spread (such as chickenpox,||
2378|147|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2378|148|P|exposed to an infection or for more details.||
2378|149|P|   Tell your health care professional that you are using||
2378|150|P|ropeginterferon alfa-2b before having any||
2378|151|P|immunizations/vaccinations. Avoid contact with people who have||
2378|152|P|recently received live vaccines (such as flu vaccine inhaled||
2378|153|P|through the nose).||
2378|154|P|   To lower the chance of getting cut, bruised, or injured, use||
2378|155|P|caution with sharp objects like razors and nail cutters, and||
2378|156|P|avoid activities such as contact sports.||
2378|157|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2378|158|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2378|159|P|machinery, or do anything that needs alertness until you can do||
2378|160|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2378|161|P|are using marijuana (cannabis).||
2378|162|P|   Before having surgery, tell your doctor or dentist about all||
2378|163|P|the products you use (including prescription drugs,||
2378|164|P|nonprescription drugs, and herbal products).||
2378|165|P|   Tell your doctor if you are pregnant or plan to become||
2378|166|P|pregnant. You should not become pregnant while using||
2378|167|P|ropeginterferon alfa-2b. Ropeginterferon alfa-2b may harm an||
2378|168|P|unborn baby. Your doctor should order a pregnancy test before you||
2378|169|P|start this medication. Ask about reliable forms of birth control||
2378|170|P|while using this medication and for at least 8 weeks after the||
2378|171|P|last dose. If you become pregnant, talk to your doctor right away||
2378|172|P|about the risks and benefits of this medication.||
2378|173|P|   It is unknown if this drug passes into breast milk. Because of||
2378|174|P|the possible risk to the infant, breastfeeding is not recommended||
2378|175|P|while using this drug and for at least 8 weeks after the last||
2378|176|P|dose. Consult your doctor before breastfeeding.||
2378|177|B|||
2378|178|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2378|179|I|medications work or increase your risk for serious side effects.||
2378|180|I|This document does not contain all possible drug interactions.||
2378|181|I|Keep a list of all the products you use (including||
2378|182|I|prescription/nonprescription drugs and herbal products) and share||
2378|183|I|it with your doctor and pharmacist. Do not start, stop, or change||
2378|184|I|the dosage of any medicines without your doctor's approval.||
2378|185|B|||
2378|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2378|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2378|188|O|poison control center right away. US residents can call||
2378|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2378|190|B|||
2378|191|N|NOTES:  Do not share this medication with others.||
2378|192|N|   Lab and/or medical tests (such as blood counts, thyroid tests,||
2378|193|N|kidney/liver function, triglyceride levels, dental and eye exams)||
2378|194|N|should be done before you start using this medication and while||
2378|195|N|you are using it. Keep all medical and lab appointments.||
2378|196|B|||
2378|197|D|MISSED DOSE:  It is important to use each dose of this medication||
2378|198|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2378|199|D|right away for a new dosing schedule.||
2378|200|B|||
2378|201|R|STORAGE:  Store in the refrigerator away from light and moisture.||
2378|202|R|Do not freeze. Keep all medications away from children and pets.||
2378|203|R|   Do not flush medications down the toilet or pour them into a||
2378|204|R|drain unless instructed to do so. Properly discard this product||
2378|205|R|when it is expired or no longer needed. Consult your pharmacist||
2378|206|R|or local waste disposal company.||
2378|207|B|||
2378|208|A|Information last revised April 2025.||
2378|209|A|Copyright(c) 2025 First Databank, Inc.||
2378|210|B|||
2379|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2379|002|Z|does NOT have all possible information about this product. This||
2379|003|Z|information does not assure that this product is safe, effective,||
2379|004|Z|or appropriate for you. This information is not individual||
2379|005|Z|medical advice and does not substitute for the advice of your||
2379|006|Z|health care professional. Always ask your health care||
2379|007|Z|professional for complete information about this product and your||
2379|008|Z|specific health needs.||
2379|009|B|||
2379|010|T|CELECOXIB SOLUTION - ORAL||
2379|011|F|(SEL-e-KOX-ib)||
2379|012|B|||
2379|013|C|COMMON BRAND NAME(S): Elyxyb||
2379|014|B|||
2379|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
2379|016|W|celecoxib) may rarely increase the risk of a heart attack or||
2379|017|W|stroke. This effect can happen at any time while taking this drug||
2379|018|W|but is more likely if you take it for a long time. The risk may||
2379|019|W|be greater in older adults or if you have heart disease or||
2379|020|W|increased risk for heart disease (for example, due to smoking,||
2379|021|W|family history of heart disease, or conditions such as high blood||
2379|022|W|pressure or diabetes). Do not take this drug right before or||
2379|023|W|after heart bypass surgery (CABG).||
2379|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
2379|025|W|bleeding from the stomach or intestines. This effect can occur||
2379|026|W|without warning symptoms at any time while taking this drug.||
2379|027|W|Older adults may be at higher risk for this effect.||
2379|028|W|   Stop taking celecoxib and get medical help right away if you||
2379|029|W|notice any of these rare but serious side effects:||
2379|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
2379|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
2379|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
2379|033|W|side of the body, trouble speaking, sudden vision changes.||
2379|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
2379|035|W|of taking this drug.||
2379|036|B|||
2379|037|U|USES:  See also Warning section.||
2379|038|U|   This medication is used to treat migraines. It helps to||
2379|039|U|relieve headache, pain, and other migraine symptoms (including||
2379|040|U|nausea, sensitivity to light/sound). Prompt treatment helps you||
2379|041|U|return to your normal routine and may decrease your need for||
2379|042|U|other pain medications. Celecoxib is a nonsteroidal||
2379|043|U|anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor.||
2379|044|U|It works by blocking your body's production of certain natural||
2379|045|U|substances that cause inflammation. This effect helps to decrease||
2379|046|U|pain and swelling.||
2379|047|B|||
2379|048|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2379|049|H|provided by your pharmacist before you start using celecoxib and||
2379|050|H|each time you get a refill. If you have any questions, ask your||
2379|051|H|doctor or pharmacist.||
2379|052|H|   Take this medication by mouth with or without food as directed||
2379|053|H|by your doctor, at the first sign of a migraine. The dosage is||
2379|054|H|based on your medical condition. Take this medication only when||
2379|055|H|needed. Do not take more than one dose in a 24-hour period.||
2379|056|H|   This medication comes in a bottle. The amount of medication in||
2379|057|H|the bottle is usually used for one dose. If instructed to take||
2379|058|H|all the medication in the bottle, drink the medication directly||
2379|059|H|from the bottle. If instructed to only use half the amount of||
2379|060|H|medication per dose, carefully measure the dose using a special||
2379|061|H|measuring device/spoon. Do not use a household spoon because you||
2379|062|H|may not get the correct dose. Discard any unused medication after||
2379|063|H|taking your dose. Do not save the unused medication left in the||
2379|064|H|bottle for later use.||
2379|065|H|   After taking the medication, you may drink up to a full glass||
2379|066|H|of water (8 ounces or 240 milliliters) unless your doctor directs||
2379|067|H|you otherwise.||
2379|068|H|   If you are using drugs for migraine attacks on 10 or more days||
2379|069|H|each month, the drugs may actually make your headaches worse||
2379|070|H|(medication overuse headache). Do not use medications more often||
2379|071|H|or for longer than directed. Tell your doctor if you need to use||
2379|072|H|this medication more often, or if the medication is not working||
2379|073|H|as well, or if your headaches get worse.||
2379|074|B|||
2379|075|S|SIDE EFFECTS:  See also Warning section.||
2379|076|S|   Changes in the sense of taste may occur. If this effect lasts||
2379|077|S|or gets worse, tell your doctor or pharmacist promptly.||
2379|078|S|   Remember that this medication has been prescribed because your||
2379|079|S|doctor has judged that the benefit to you is greater than the||
2379|080|S|risk of side effects. Many people using this medication do not||
2379|081|S|have serious side effects.||
2379|082|S|   This medication may raise your blood pressure. Check your||
2379|083|S|blood pressure regularly and tell your doctor if the results are||
2379|084|S|high.||
2379|085|S|   Tell your doctor right away if you have any serious side||
2379|086|S|effects, including: pain/swelling/warmth in the groin/calf, signs||
2379|087|S|of kidney problems (such as change in the amount of urine),||
2379|088|S|difficult/painful swallowing, symptoms of heart failure (such as||
2379|089|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
2379|090|S|gain).||
2379|091|S|   This drug may rarely cause serious (possibly fatal) liver||
2379|092|S|disease. Get medical help right away if you have any symptoms of||
2379|093|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
2379|094|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2379|095|S|urine.||
2379|096|S|   A very serious allergic reaction to this drug is rare.||
2379|097|S|However, get medical help right away if you notice any symptoms||
2379|098|S|of a serious allergic reaction, including: fever, swollen lymph||
2379|099|S|nodes, rash, itching/swelling (especially of the||
2379|100|S|face/tongue/throat), severe dizziness, trouble breathing.||
2379|101|S|   This is not a complete list of possible side effects. If you||
2379|102|S|notice other effects not listed above, contact your doctor or||
2379|103|S|pharmacist.||
2379|104|S|   In the US -||
2379|105|S|   Call your doctor for medical advice about side effects. You||
2379|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2379|107|S|www.fda.gov/medwatch.||
2379|108|S|   In Canada - Call your doctor for medical advice about side||
2379|109|S|effects. You may report side effects to Health Canada at||
2379|110|S|1-866-234-2345.||
2379|111|B|||
2379|112|P|PRECAUTIONS:  See also Warning section.||
2379|113|P|   Before taking celecoxib, tell your doctor or pharmacist if you||
2379|114|P|are allergic to it; or to aspirin or other NSAIDs (such as||
2379|115|P|ibuprofen, naproxen); or if you have any other allergies. This||
2379|116|P|product may contain inactive ingredients, which can cause||
2379|117|P|allergic reactions or other problems. Talk to your pharmacist for||
2379|118|P|more details.||
2379|119|P|   Before using this medication, tell your doctor or pharmacist||
2379|120|P|your medical history, especially of: asthma (including a history||
2379|121|P|of worsening breathing with runny/stuffy nose after taking||
2379|122|P|aspirin or other NSAIDs), bleeding/clotting problems, blood||
2379|123|P|disorders (such as anemia), growths in the nose (nasal polyps),||
2379|124|P|heart disease (such as previous heart attack), high blood||
2379|125|P|pressure, liver disease, stroke, swelling (edema, fluid||
2379|126|P|retention), stomach/intestine/esophagus problems (such as||
2379|127|P|bleeding, ulcers, recurring heartburn).||
2379|128|P|   Kidney problems can sometimes occur with the use of NSAID||
2379|129|P|medications, including celecoxib. Problems are more likely to||
2379|130|P|occur if you are dehydrated, have heart failure or kidney||
2379|131|P|disease, are an older adult, or if you take certain medications||
2379|132|P|(see also Drug Interactions section). Drink plenty of fluids as||
2379|133|P|directed by your doctor to prevent dehydration and tell your||
2379|134|P|doctor right away if you have any unusual change in the amount of||
2379|135|P|urine.||
2379|136|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
2379|137|P|and tobacco, especially when combined with this medicine, may||
2379|138|P|increase your risk for stomach bleeding. Limit alcohol and stop||
2379|139|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
2379|140|P|may safely drink.||
2379|141|P|   Before having surgery, tell your doctor or dentist about all||
2379|142|P|the products you use (including prescription drugs,||
2379|143|P|nonprescription drugs, and herbal products).||
2379|144|P|   Older adults may be at greater risk for stomach/intestinal||
2379|145|P|bleeding, kidney problems, heart attack, and stroke while using||
2379|146|P|this drug.||
2379|147|P|   Before using this medication, women of childbearing age should||
2379|148|P|talk with their doctor(s) about the benefits and risks. Tell your||
2379|149|P|doctor if you are pregnant or if you plan to become pregnant.||
2379|150|P|This medication may harm an unborn baby and cause problems with||
2379|151|P|normal labor/delivery. It is not recommended for use in pregnancy||
2379|152|P|from 20 weeks until delivery. If your doctor decides that you||
2379|153|P|need to use this medication between 20 and 30 weeks of pregnancy,||
2379|154|P|you should use the lowest effective dose for the shortest||
2379|155|P|possible time. You should not use this medication after 30 weeks||
2379|156|P|of pregnancy.||
2379|157|P|   This medication passes into breast milk. Consult your doctor||
2379|158|P|before breastfeeding.||
2379|159|B|||
2379|160|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2379|161|I|medications work or increase your risk for serious side effects.||
2379|162|I|This document does not contain all possible drug interactions.||
2379|163|I|Keep a list of all the products you use (including||
2379|164|I|prescription/nonprescription drugs and herbal products) and share||
2379|165|I|it with your doctor and pharmacist. Do not start, stop, or change||
2379|166|I|the dosage of any medicines without your doctor's approval.||
2379|167|I|   Some products that may interact with this drug are: aliskiren,||
2379|168|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
2379|169|I|receptor blockers (such as valsartan, losartan), cidofovir,||
2379|170|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
2379|171|I|methotrexate, "water pills" (diuretics such as furosemide).||
2379|172|I|   This medication may increase the risk of bleeding when taken||
2379|173|I|with other drugs that also may cause bleeding. Examples include||
2379|174|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2379|175|I|dabigatran/enoxaparin/warfarin, among others.||
2379|176|I|   Check all prescription and nonprescription medicine labels||
2379|177|I|carefully since many medications contain pain relievers/fever||
2379|178|I|reducers (aspirin, NSAIDs such as naproxen, ibuprofen,||
2379|179|I|ketorolac). These drugs are similar to celecoxib and may increase||
2379|180|I|your risk of side effects if taken together. However, if your||
2379|181|I|doctor has told you to take low-dose aspirin to prevent heart||
2379|182|I|attack or stroke (usually 81-162 milligrams a day), you should||
2379|183|I|keep taking the aspirin unless your doctor tells you not to. Ask||
2379|184|I|your doctor or pharmacist for more details.||
2379|185|B|||
2379|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2379|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2379|188|O|poison control center right away. US residents can call||
2379|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2379|190|O|Symptoms of overdose may include: severe stomach pain,||
2379|191|O|slow/shallow breathing, or loss of consciousness.||
2379|192|B|||
2379|193|N|NOTES:  Do not share this medication with others.||
2379|194|N|   Certain foods, beverages, or food additives (such as red wine,||
2379|195|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
2379|196|N|patterns such as irregular eating/sleeping habits or stress may||
2379|197|N|bring on a migraine headache. Avoiding these "triggers" may help||
2379|198|N|lessen migraine attacks. Consult your doctor for more details.||
2379|199|N|   Lab and/or medical tests (such as blood pressure, complete||
2379|200|N|blood count, liver/kidney function) may be done while you are||
2379|201|N|using this medication. Keep all medical and lab appointments.||
2379|202|N|Consult your doctor for more details.||
2379|203|B|||
2379|204|D|MISSED DOSE:  Not applicable.||
2379|205|B|||
2379|206|R|STORAGE:  Store at room temperature. Do not refrigerate or||
2379|207|R|freeze. Keep all medications away from children and pets.||
2379|208|R|   Do not flush medications down the toilet or pour them into a||
2379|209|R|drain unless instructed to do so. Properly discard this product||
2379|210|R|when it is expired or no longer needed. Consult your pharmacist||
2379|211|R|or local waste disposal company.||
2379|212|B|||
2379|213|A|Information last revised November 2025.||
2379|214|A|Copyright(c) 2025 First Databank, Inc.||
2379|215|B|||
2380|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2380|002|Z|does NOT have all possible information about this product. This||
2380|003|Z|information does not assure that this product is safe, effective,||
2380|004|Z|or appropriate for you. This information is not individual||
2380|005|Z|medical advice and does not substitute for the advice of your||
2380|006|Z|health care professional. Always ask your health care||
2380|007|Z|professional for complete information about this product and your||
2380|008|Z|specific health needs.||
2380|009|B|||
2380|010|T|MARIBAVIR - ORAL||
2380|011|F|(ma-RYE-ba-vir)||
2380|012|B|||
2380|013|C|COMMON BRAND NAME(S): Livtencity||
2380|014|B|||
2380|015|U|USES:  This medication is used to treat cytomegalovirus (CMV)||
2380|016|U|disease or infection in people who have received a transplant.||
2380|017|U|Maribavir is an anti-viral drug. It works by stopping the growth||
2380|018|U|of the virus.||
2380|019|B|||
2380|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
2380|021|H|Instructions for Use if available from your pharmacist before you||
2380|022|H|start taking maribavir and each time you get a refill. If you||
2380|023|H|have any questions, ask your doctor or pharmacist.||
2380|024|H|   Take this medication by mouth with or without food, as||
2380|025|H|directed by your doctor, usually twice daily. The dosage is based||
2380|026|H|on your medical condition, response to treatment, and other||
2380|027|H|medications you may be taking. Be sure to tell your doctor and||
2380|028|H|pharmacist about all the products you use (including prescription||
2380|029|H|drugs, nonprescription drugs, and herbal products).||
2380|030|H|   This medication may be swallowed whole or may be mixed with||
2380|031|H|water before being taken. If you have trouble swallowing the||
2380|032|H|tablets whole, you may place the prescribed dose in a small||
2380|033|H|container of drinking water. Use the amount of drinking water for||
2380|034|H|your dose as described in the Instructions for Use. If you||
2380|035|H|prefer, you can also crush the tablets with a spoon before adding||
2380|036|H|drinking water to the container. Swirl the container gently to||
2380|037|H|mix the tablet pieces in the water and drink the mixture right||
2380|038|H|away. The mixture will taste bitter. Rinse the container with a||
2380|039|H|tablespoonful/15 milliliters of drinking water and drink again.||
2380|040|H|If any pieces of tablet remain in the container, add another||
2380|041|H|tablespoonful/15 milliliters of drinking water and drink. Repeat||
2380|042|H|until you have taken all of your dose. If needed, the suspension||
2380|043|H|may be prepared ahead of time. Store the prepared suspension at||
2380|044|H|room temperature and use it within 8 hours.||
2380|045|H|   If you are giving this medication through a tube into the||
2380|046|H|stomach (nasogastric or orogastric tube), consult the||
2380|047|H|Instructions for Use or your health care professional for||
2380|048|H|detailed instructions on how to properly give it.||
2380|049|H|   For the best effect, take this medication at evenly spaced||
2380|050|H|times. To help you remember, take this medication at the same||
2380|051|H|times every day.||
2380|052|H|   Continue to take this medication until the full prescribed||
2380|053|H|amount is finished, even if symptoms disappear after a few days.||
2380|054|H|Stopping the medication too early may result in a return of the||
2380|055|H|infection.||
2380|056|H|   Tell your doctor if your condition lasts or gets worse.||
2380|057|B|||
2380|058|S|SIDE EFFECTS:  Nausea, diarrhea, vomiting, tiredness, or changes||
2380|059|S|in taste may occur. If any of these effects last or get worse,||
2380|060|S|tell your doctor or pharmacist promptly.||
2380|061|S|   Remember that this medication has been prescribed because your||
2380|062|S|doctor has judged that the benefit to you is greater than the||
2380|063|S|risk of side effects. Many people using this medication do not||
2380|064|S|have serious side effects.||
2380|065|S|   A very serious allergic reaction to this drug is rare.||
2380|066|S|However, get medical help right away if you notice any symptoms||
2380|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2380|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2380|069|S|breathing.||
2380|070|S|   This is not a complete list of possible side effects. If you||
2380|071|S|notice other effects not listed above, contact your doctor or||
2380|072|S|pharmacist.||
2380|073|S|   In the US -||
2380|074|S|   Call your doctor for medical advice about side effects. You||
2380|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2380|076|S|www.fda.gov/medwatch.||
2380|077|S|   In Canada - Call your doctor for medical advice about side||
2380|078|S|effects. You may report side effects to Health Canada at||
2380|079|S|1-866-234-2345.||
2380|080|B|||
2380|081|P|PRECAUTIONS:  Before taking maribavir, tell your doctor or||
2380|082|P|pharmacist if you are allergic to it; or if you have any other||
2380|083|P|allergies. This product may contain inactive ingredients, which||
2380|084|P|can cause allergic reactions or other problems. Talk to your||
2380|085|P|pharmacist for more details.||
2380|086|P|   Before using this medication, tell your doctor or pharmacist||
2380|087|P|your medical history.||
2380|088|P|   Before having surgery, tell your doctor or dentist about all||
2380|089|P|the products you use (including prescription drugs,||
2380|090|P|nonprescription drugs, and herbal products).||
2380|091|P|   During pregnancy, this medication should be used only when||
2380|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
2380|093|P|   It is unknown if this drug passes into breast milk. Consult||
2380|094|P|your doctor before breastfeeding.||
2380|095|B|||
2380|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2380|097|I|medications work or increase your risk for serious side effects.||
2380|098|I|This document does not contain all possible drug interactions.||
2380|099|I|Keep a list of all the products you use (including||
2380|100|I|prescription/nonprescription drugs and herbal products) and share||
2380|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
2380|102|I|the dosage of any medicines without your doctor's approval.||
2380|103|I|   Some products that may interact with this drug are:||
2380|104|I|ganciclovir, valganciclovir.||
2380|105|I|   Other medications can affect the removal of maribavir from||
2380|106|I|your body, which may affect how maribavir works. Examples include||
2380|107|I|rifamycins (such as rifabutin), St. John's wort, among others.||
2380|108|B|||
2380|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2380|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2380|111|O|poison control center right away. US residents can call||
2380|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2380|113|B|||
2380|114|N|NOTES:  Do not share this medication with others.||
2380|115|N|   This medication has been prescribed for your current condition||
2380|116|N|only. Do not use it later for another infection unless your||
2380|117|N|doctor tells you to.||
2380|118|B|||
2380|119|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2380|120|D|remember. If it is near the time of the next dose, skip the||
2380|121|D|missed dose. Take your next dose at the regular time. Do not||
2380|122|D|double the dose to catch up.||
2380|123|B|||
2380|124|R|STORAGE:  Store at room temperature away from light and moisture.||
2380|125|R|Do not store in the bathroom. Keep all medications away from||
2380|126|R|children and pets.||
2380|127|R|   Do not flush medications down the toilet or pour them into a||
2380|128|R|drain unless instructed to do so. Properly discard this product||
2380|129|R|when it is expired or no longer needed. Consult your pharmacist||
2380|130|R|or local waste disposal company.||
2380|131|B|||
2380|132|A|Information last revised May 2024.||
2380|133|A|Copyright(c) 2025 First Databank, Inc.||
2380|134|B|||
2382|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2382|002|Z|does NOT have all possible information about this product. This||
2382|003|Z|information does not assure that this product is safe, effective,||
2382|004|Z|or appropriate for you. This information is not individual||
2382|005|Z|medical advice and does not substitute for the advice of your||
2382|006|Z|health care professional. Always ask your health care||
2382|007|Z|professional for complete information about this product and your||
2382|008|Z|specific health needs.||
2382|009|B|||
2382|010|T|FOLLITROPIN ALFA/LUTROPIN ALFA - INJECTION||
2382|011|F|(FOL-i-TROE-pin AL-fa/loo-TROE-pin AL-fa)||
2382|012|B|||
2382|013|U|USES:  This medication contains follicle-stimulating hormone||
2382|014|U|(FSH) and luteinizing hormone (LH). It is used to treat certain||
2382|015|U|fertility problems in women. This medication is usually used in||
2382|016|U|combination with another hormone (hCG) to bring about the growth||
2382|017|U|and release of a mature egg (ovulation).||
2382|018|U|   This medication is not recommended for women whose ovaries no||
2382|019|U|longer make eggs properly (primary ovarian failure).||
2382|020|B|||
2382|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2382|022|H|Instructions for Use if available from your pharmacist before you||
2382|023|H|start using this medication and each time you get a refill. Ask||
2382|024|H|your health care professional how to prepare and use this||
2382|025|H|medication. If you have any questions, ask your doctor or||
2382|026|H|pharmacist.||
2382|027|H|   Inject this medication under the skin as directed by your||
2382|028|H|doctor, usually once a day. The injection is given in the thighs||
2382|029|H|or abdomen. Your doctor may direct you to use this medication in||
2382|030|H|a treatment cycle (for example, only on certain days each month).||
2382|031|H|The dosage is based on your medical condition, response to||
2382|032|H|treatment, and labs.||
2382|033|H|   If the medication is stored in the refrigerator, allow the||
2382|034|H|medication to reach room temperature before use. Before using,||
2382|035|H|check this product for particles or discoloration. If either is||
2382|036|H|present, do not use the liquid. Before injecting each dose, clean||
2382|037|H|the skin you are going to inject into (the injection site) with||
2382|038|H|rubbing alcohol. Change the injection site each time to lessen||
2382|039|H|injury under the skin. To lessen bruising, do not rub the||
2382|040|H|injection site after a shot. Learn how to store and discard||
2382|041|H|medical supplies safely.||
2382|042|H|   Use this medication exactly as directed by your doctor to get||
2382|043|H|the most benefit from it. Do not increase your dose or use this||
2382|044|H|drug more often or for longer than prescribed.||
2382|045|B|||
2382|046|S|SIDE EFFECTS:  Headache, nausea, mild stomach/abdominal pain,||
2382|047|S|diarrhea, constipation, flatulence, redness/pain at the injection||
2382|048|S|site, or breast tenderness/pain may occur. If any of these||
2382|049|S|effects last or get worse, tell your doctor or pharmacist||
2382|050|S|promptly.||
2382|051|S|   Remember that this medication has been prescribed because your||
2382|052|S|doctor has judged that the benefit to you is greater than the||
2382|053|S|risk of side effects. Many people using this medication do not||
2382|054|S|have serious side effects.||
2382|055|S|   Tell your doctor right away if you have any serious side||
2382|056|S|effects, including: unusual bleeding from the vagina/uterus,||
2382|057|S|pain/swelling in the lower abdominal (pelvic) area, flu-like||
2382|058|S|symptoms (such as fever, chills, muscle ache, tiredness),||
2382|059|S|swelling of ankles/hands/feet.||
2382|060|S|   Get medical help right away if you have any very serious side||
2382|061|S|effects, including: shortness of breath/rapid breathing,||
2382|062|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
2382|063|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
2382|064|S|sudden severe headache, trouble speaking, weakness on one side of||
2382|065|S|the body, sudden vision changes.||
2382|066|S|   This medication may cause a condition known as ovarian||
2382|067|S|hyperstimulation syndrome (OHSS). This condition may occur during||
2382|068|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
2382|069|S|build up in the stomach, chest, and heart area. Get medical help||
2382|070|S|right away if you develop the following side effects: severe pain||
2382|071|S|or swelling in the lower abdominal (pelvic) area, severe||
2382|072|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
2382|073|S|urination.||
2382|074|S|   A very serious allergic reaction to this drug is rare.||
2382|075|S|However, get medical help right away if you notice any symptoms||
2382|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2382|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2382|078|S|breathing.||
2382|079|S|   This is not a complete list of possible side effects. If you||
2382|080|S|notice other effects not listed above, contact your doctor or||
2382|081|S|pharmacist.||
2382|082|S|   In the US -||
2382|083|S|   Call your doctor for medical advice about side effects. You||
2382|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2382|085|S|www.fda.gov/medwatch.||
2382|086|S|   In Canada - Call your doctor for medical advice about side||
2382|087|S|effects. You may report side effects to Health Canada at||
2382|088|S|1-866-234-2345.||
2382|089|B|||
2382|090|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2382|091|P|pharmacist if you are allergic to it; or to other products||
2382|092|P|containing follicle-stimulating hormone (FSH) or luteinizing||
2382|093|P|hormone (LH); or if you have any other allergies. This product||
2382|094|P|may contain inactive ingredients, which can cause allergic||
2382|095|P|reactions or other problems. Talk to your pharmacist for more||
2382|096|P|details.||
2382|097|P|   Before using this medication, tell your doctor or pharmacist||
2382|098|P|your medical history, especially of: other fertility problems||
2382|099|P|(such as primary ovarian failure), abnormal bleeding from the||
2382|100|P|vagina/uterus, ovarian cysts or enlarged ovaries, cancer of the||
2382|101|P|reproductive organs (such as breast, uterus, ovary), tumor in the||
2382|102|P|brain (such as pituitary/hypothalamus tumor), thyroid problems,||
2382|103|P|adrenal gland problems, blood clots, stroke, certain heart||
2382|104|P|diseases (such as angina, heart attack), lung problems (such as||
2382|105|P|asthma).||
2382|106|P|   Before having surgery, tell your doctor or dentist about all||
2382|107|P|the products you use (including prescription drugs,||
2382|108|P|nonprescription drugs, and herbal products).||
2382|109|P|   Multiple births may occur as a result of this treatment.||
2382|110|P|Consult your doctor for more details.||
2382|111|P|   Stop using this medication when you become pregnant. This||
2382|112|P|medication must not be used during pregnancy. If you think you||
2382|113|P|may be pregnant, tell your doctor right away.||
2382|114|P|   It is unknown if this drug passes into breast milk. Consult||
2382|115|P|your doctor before breastfeeding.||
2382|116|B|||
2382|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2382|118|I|medications work or increase your risk for serious side effects.||
2382|119|I|This document does not contain all possible drug interactions.||
2382|120|I|Keep a list of all the products you use (including||
2382|121|I|prescription/nonprescription drugs and herbal products) and share||
2382|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
2382|123|I|the dosage of any medicines without your doctor's approval.||
2382|124|I|   A product that may interact with this drug is: gonadorelin.||
2382|125|B|||
2382|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2382|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2382|128|O|poison control center right away. US residents can call||
2382|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2382|130|B|||
2382|131|N|NOTES:  Do not share this medication with others.||
2382|132|N|   Lab and/or medical tests (such as vaginal/ovary ultrasound,||
2382|133|N|hormone levels, liver tests) may be done while you are using this||
2382|134|N|medication. Keep all medical and lab appointments. Consult your||
2382|135|N|doctor for more details.||
2382|136|B|||
2382|137|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
2382|138|D|right away for a new dosing schedule. Do not double the dose to||
2382|139|D|catch up.||
2382|140|B|||
2382|141|R|STORAGE:  Store the unused pen in the refrigerator. Do not||
2382|142|R|freeze. Keep the medication in the original package to protect||
2382|143|R|from light. Once used, the pen may be stored at room temperature.||
2382|144|R|Discard the used pen after 28 days. Keep all medications away||
2382|145|R|from children and pets.||
2382|146|R|   Do not flush medications down the toilet or pour them into a||
2382|147|R|drain unless instructed to do so. Properly discard this product||
2382|148|R|when it is expired or no longer needed. Consult your pharmacist||
2382|149|R|or local waste disposal company.||
2382|150|B|||
2382|151|A|Information last revised August 2024.||
2382|152|A|Copyright(c) 2025 First Databank, Inc.||
2382|153|B|||
2383|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2383|002|Z|does NOT have all possible information about this product. This||
2383|003|Z|information does not assure that this product is safe, effective,||
2383|004|Z|or appropriate for you. This information is not individual||
2383|005|Z|medical advice and does not substitute for the advice of your||
2383|006|Z|health care professional. Always ask your health care||
2383|007|Z|professional for complete information about this product and your||
2383|008|Z|specific health needs.||
2383|009|B|||
2383|010|T|MACITENTAN/TADALAFIL - ORAL||
2383|011|F|(MA-si-TEN-tan/ta-DA-la-fil)||
2383|012|B|||
2383|013|C|COMMON BRAND NAME(S): Opsynvi||
2383|014|B|||
2383|015|W|WARNING:  This medication must not be used during pregnancy.||
2383|016|W|Macitentan may harm an unborn baby. It is important to prevent||
2383|017|W|pregnancy while taking this medication and for 1 month after||
2383|018|W|treatment. Female patients must use reliable birth control before||
2383|019|W|starting treatment, during treatment, and for 1 month after the||
2383|020|W|last dose. Ask your doctor which forms of birth control to use||
2383|021|W|while taking this medication. Female patients must take a||
2383|022|W|pregnancy test before starting treatment. If you become pregnant||
2383|023|W|or think you may be pregnant, tell your doctor right away.||
2383|024|B|||
2383|025|U|USES:  This combination medication contains 2 drugs: macitentan||
2383|026|U|and tadalafil. It is used by people who are currently taking||
2383|027|U|stable doses of these 2 drugs to treat high blood pressure in the||
2383|028|U|lungs (pulmonary hypertension). Macitentan blocks the effects of||
2383|029|U|a certain natural substance (endothelin-1). Blocking this||
2383|030|U|substance helps decrease blood pressure in the lungs. Tadalafil||
2383|031|U|works by relaxing and widening the blood vessels in your lungs||
2383|032|U|which allows the blood to flow more easily. Decreasing high blood||
2383|033|U|pressure in the lungs allows your heart and lungs to work better||
2383|034|U|and improves your ability to exercise.||
2383|035|B|||
2383|036|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2383|037|H|Patient Information Leaflet provided by your pharmacist before||
2383|038|H|you start taking macitentan/tadalafil and each time you get a||
2383|039|H|refill. If you have any questions, ask your doctor or pharmacist.||
2383|040|H|   Take this medication by mouth with or without food as directed||
2383|041|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2383|042|H|not break, crush, or chew the tablets. The dosage is based on||
2383|043|H|your medical condition, response to treatment, and other||
2383|044|H|medications you may be taking. Be sure to tell your doctor and||
2383|045|H|pharmacist about all the products you use (including prescription||
2383|046|H|drugs, nonprescription drugs, and herbal products).||
2383|047|H|   Take this medication regularly to get the most benefit from||
2383|048|H|it. To help you remember, take it at the same time each day.||
2383|049|H|   Since this drug can be absorbed through the skin and lungs and||
2383|050|H|may harm an unborn baby, women who are pregnant or who may become||
2383|051|H|pregnant should not handle this medication or breathe the dust||
2383|052|H|from the tablets.||
2383|053|H|   Tell your doctor if your condition does not get better or if||
2383|054|H|it gets worse.||
2383|055|B|||
2383|056|S|SIDE EFFECTS:  Runny/stuffy nose, sore throat, cough, chills,||
2383|057|S|dizziness, lightheadedness, headache, muscle pain, flushing,||
2383|058|S|nausea, vomiting, or stomach upset may occur. If any of these||
2383|059|S|effects last or gets worse, tell your doctor or pharmacist||
2383|060|S|promptly.||
2383|061|S|   To reduce the risk of dizziness and lightheadedness, get up||
2383|062|S|slowly when rising from a sitting or lying position.||
2383|063|S|   Remember that this medication has been prescribed because your||
2383|064|S|doctor has judged that the benefit to you is greater than the||
2383|065|S|risk of side effects. Many people using this medication do not||
2383|066|S|have serious side effects.||
2383|067|S|   Tell your doctor right away if you have any serious side||
2383|068|S|effects, including: signs of low red blood cell count (such as||
2383|069|S|unusual tiredness, rapid breathing, pale skin, shortness of||
2383|070|S|breath, fast heartbeat), unusual weight gain, increased shortness||
2383|071|S|of breath or trouble breathing, new or worsening swelling of the||
2383|072|S|hands/ankles/feet, signs of liver disease (such as||
2383|073|S|nausea/vomiting that doesn't stop, dark urine, stomach/abdominal||
2383|074|S|pain, yellowing eyes/skin).||
2383|075|S|   Rarely, sudden decreased vision, or even permanent blindness,||
2383|076|S|may occur in one or both eyes (NAION). If this serious problem||
2383|077|S|occurs, stop taking this medication and get medical help right||
2383|078|S|away. You have a slightly greater chance of developing NAION if||
2383|079|S|you have heart disease, diabetes, high cholesterol, certain other||
2383|080|S|eye problems ("crowded disk"), high blood pressure, if you are||
2383|081|S|over 50, or if you smoke.||
2383|082|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
2383|083|S|ringing in the ears and dizziness, may occur. Stop taking this||
2383|084|S|medication and get medical help right away if you get any of||
2383|085|S|these side effects.||
2383|086|S|   Rarely, males may have a painful or prolonged erection lasting||
2383|087|S|4 or more hours. If this occurs, stop using this drug and get||
2383|088|S|medical help right away, or permanent problems could occur.||
2383|089|S|   A very serious allergic reaction to this drug is rare.||
2383|090|S|However, get medical help right away if you notice any symptoms||
2383|091|S|of a serious allergic reaction, including: rash, itching/swelling||
2383|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2383|093|S|breathing.||
2383|094|S|   This is not a complete list of possible side effects. If you||
2383|095|S|notice other effects not listed above, contact your doctor or||
2383|096|S|pharmacist.||
2383|097|S|   In the US -||
2383|098|S|   Call your doctor for medical advice about side effects. You||
2383|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2383|100|S|www.fda.gov/medwatch.||
2383|101|S|   In Canada - Call your doctor for medical advice about side||
2383|102|S|effects. You may report side effects to Health Canada at||
2383|103|S|1-866-234-2345.||
2383|104|B|||
2383|105|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2383|106|P|pharmacist if you are allergic to macitentan or tadalafil; or if||
2383|107|P|you have any other allergies. This product may contain inactive||
2383|108|P|ingredients, which can cause allergic reactions or other||
2383|109|P|problems. Talk to your pharmacist for more details.||
2383|110|P|   Before using this medication, tell your doctor or pharmacist||
2383|111|P|your medical history, especially of: bleeding/blood disorders||
2383|112|P|(such as anemia), other lung conditions (such as pulmonary||
2383|113|P|veno-occlusive disease), heart problems (such as angina, previous||
2383|114|P|heart attack, irregular heartbeat, heart failure), kidney||
2383|115|P|disease, liver disease, high or low blood pressure, dehydration,||
2383|116|P|penis conditions (such as angulation, fibrosis/scarring,||
2383|117|P|Peyronie's disease), history of painful/prolonged erection||
2383|118|P|(priapism), conditions that may increase the risk of priapism||
2383|119|P|(such as sickle cell anemia, leukemia, multiple myeloma), eye||
2383|120|P|problems (such as retinitis pigmentosa, sudden decreased vision,||
2383|121|P|NAION), stroke.||
2383|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2383|123|P|can make you more dizzy. Do not drive, use machinery, or do||
2383|124|P|anything that needs alertness until you can do it safely. Limit||
2383|125|P|alcoholic beverages. Talk to your doctor if you are using||
2383|126|P|marijuana (cannabis).||
2383|127|P|   Before having surgery, tell your doctor or dentist about all||
2383|128|P|the products you use (including prescription drugs,||
2383|129|P|nonprescription drugs, and herbal products).||
2383|130|P|   This medication can affect fertility in males. Ask your doctor||
2383|131|P|for more details.||
2383|132|P|   Since this drug can be absorbed through the skin and lungs and||
2383|133|P|may harm an unborn baby, women who are pregnant or who may become||
2383|134|P|pregnant should not handle this medication or breathe the dust||
2383|135|P|from the tablets.||
2383|136|P|   This medication must not be used during pregnancy. It may harm||
2383|137|P|an unborn baby. Discuss the use of reliable forms of birth||
2383|138|P|control (such as condoms, birth control pills) before starting||
2383|139|P|treatment, during treatment, and for 1 month after the last dose.||
2383|140|P|If you become pregnant or think you may be pregnant, tell your||
2383|141|P|doctor right away. See also Warning section.||
2383|142|P|   It is unknown if this medication passes into breast milk.||
2383|143|P|Because of the possible risk to the infant, breastfeeding is not||
2383|144|P|recommended while using this medication. Consult your doctor||
2383|145|P|before breastfeeding.||
2383|146|B|||
2383|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2383|148|I|medications work or increase your risk for serious side effects.||
2383|149|I|This document does not contain all possible drug interactions.||
2383|150|I|Keep a list of all the products you use (including||
2383|151|I|prescription/nonprescription drugs and herbal products) and share||
2383|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
2383|153|I|the dosage of any medicines without your doctor's approval.||
2383|154|I|   Some products that may interact with this drug are: riociguat,||
2383|155|I|sparsentan, vericiguat.||
2383|156|I|   When used with nitrates, this medication can cause a serious||
2383|157|I|drop in your blood pressure, which can lead to dizziness,||
2383|158|I|fainting, and rarely heart attack or stroke. Do not use any of||
2383|159|I|the following drugs during treatment with this medication or||
2383|160|I|within 48 hours of your last dose of macitentan/tadalafil:||
2383|161|I|certain drugs used to treat chest pain/angina (nitrates such as||
2383|162|I|nitroglycerin, isosorbide), recreational drugs called "poppers"||
2383|163|I|containing amyl or butyl nitrite.||
2383|164|I|   If you are also taking an alpha blocker medication (such as||
2383|165|I|doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high||
2383|166|I|blood pressure, your blood pressure may get too low which can||
2383|167|I|lead to dizziness or fainting. Your doctor may adjust your||
2383|168|I|medications to minimize your risk of low blood pressure.||
2383|169|I|   Other medications can affect the removal of||
2383|170|I|macitentan/tadalafil from your body, which may affect how this||
2383|171|I|medication works. Examples include amiodarone, azole antifungals||
2383|172|I|(such as itraconazole, ketoconazole), macrolide antibiotics (such||
2383|173|I|as clarithromycin, erythromycin), cobicistat, HIV protease||
2383|174|I|inhibitors (such as lopinavir, ritonavir), rifamycins (such as||
2383|175|I|rifampin), among others.||
2383|176|I|   Do not take this medication with any other product that||
2383|177|I|contains tadalafil or other similar medications for erectile||
2383|178|I|dysfunction-ED or pulmonary hypertension (such as sildenafil,||
2383|179|I|vardenafil).||
2383|180|B|||
2383|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2383|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2383|183|O|poison control center right away. US residents can call||
2383|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2383|185|B|||
2383|186|N|NOTES:  Do not share this medication with others.||
2383|187|N|   Lab and/or medical tests (such as blood pressure, complete||
2383|188|N|blood count, kidney/liver tests) may be done while you are taking||
2383|189|N|this medication. Keep all medical and lab appointments.||
2383|190|B|||
2383|191|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2383|192|D|remember. If it is near the time of the next dose, skip the||
2383|193|D|missed dose. Take your next dose at the regular time. Do not||
2383|194|D|double the dose to catch up.||
2383|195|B|||
2383|196|R|STORAGE:  Store in the original container at room temperature||
2383|197|R|away from light and moisture. Do not store in the bathroom. Keep||
2383|198|R|the drying agent (desiccant) in the bottle. Tightly close the||
2383|199|R|bottle when not in use. Keep all medications away from children||
2383|200|R|and pets.||
2383|201|R|   Do not flush medications down the toilet or pour them into a||
2383|202|R|drain unless instructed to do so. Properly discard this product||
2383|203|R|when it is expired or no longer needed. Consult your pharmacist||
2383|204|R|or local waste disposal company.||
2383|205|B|||
2383|206|A|Information last revised April 2025.||
2383|207|A|Copyright(c) 2025 First Databank, Inc.||
2383|208|B|||
2384|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2384|002|Z|does NOT have all possible information about this product. This||
2384|003|Z|information does not assure that this product is safe, effective,||
2384|004|Z|or appropriate for you. This information is not individual||
2384|005|Z|medical advice and does not substitute for the advice of your||
2384|006|Z|health care professional. Always ask your health care||
2384|007|Z|professional for complete information about this product and your||
2384|008|Z|specific health needs.||
2384|009|B|||
2384|010|T|NIRMATRELVIR/RITONAVIR - ORAL||
2384|011|F|(nir-MA-trel-vir/ri-TON-na-vir)||
2384|012|B|||
2384|013|C|COMMON BRAND NAME(S): Paxlovid||
2384|014|B|||
2384|015|W|WARNING:  This product contains a combination of nirmatrelvir||
2384|016|W|tablets and ritonavir tablets. Ritonavir may interact with many||
2384|017|W|different types of medications, in some cases causing severe||
2384|018|W|(sometimes fatal) reactions. Before using nirmatrelvir and||
2384|019|W|ritonavir, tell your doctor and pharmacist about all the products||
2384|020|W|you use (including prescription drugs, nonprescription drugs, and||
2384|021|W|herbal products). Also, before you start using any new product,||
2384|022|W|ask your doctor and pharmacist if it could interact with||
2384|023|W|nirmatrelvir and ritonavir. Consult your doctor or pharmacist||
2384|024|W|about which medications should not be taken with this product||
2384|025|W|(see also Drug Interactions section).||
2384|026|B|||
2384|027|U|USES:  This combination of nirmatrelvir and ritonavir is used to||
2384|028|U|treat coronavirus disease (COVID-19) in people who have mild to||
2384|029|U|moderate symptoms and have a high risk for COVID-19||
2384|030|U|complications. It helps people who have COVID-19 to stay out of||
2384|031|U|the hospital. It is not for use by people who are hospitalized||
2384|032|U|due to COVID-19.||
2384|033|U|   Nirmatrelvir is a SARS-CoV-2 main protease inhibitor. It works||
2384|034|U|by preventing the growth of the virus that causes COVID-19.||
2384|035|U|Ritonavir increases ("boosts") the levels of nirmatrelvir. This||
2384|036|U|helps nirmatrelvir work better.||
2384|037|U|   This medication works by stopping the coronavirus from||
2384|038|U|growing. It cannot be used to prevent COVID-19.||
2384|039|B|||
2384|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2384|041|H|from your pharmacist before you start taking this product and||
2384|042|H|each time you get a refill. If you have any questions, ask your||
2384|043|H|doctor or pharmacist.||
2384|044|H|   Take this medication by mouth with or without food as directed||
2384|045|H|by your doctor, usually once or twice daily for 5 days. If you||
2384|046|H|are on dialysis, take your dose of this medication after dialysis||
2384|047|H|on your dialysis days. Swallow the tablets whole. Do not chew,||
2384|048|H|break, or crush the tablets. The dosage is based on your medical||
2384|049|H|condition and response to treatment.||
2384|050|H|   This product works best if you start taking it within 5 days||
2384|051|H|of when symptoms begin.||
2384|052|H|   For the best effect, take this product at evenly spaced times.||
2384|053|H|To help you remember, take it at the same times every day.||
2384|054|H|   Continue to take this medication until the full prescribed||
2384|055|H|amount is finished, even if symptoms disappear after a few days.||
2384|056|H|Stopping the medication too early may result in a return of the||
2384|057|H|infection.||
2384|058|H|   Tell your doctor if your condition lasts or gets worse.||
2384|059|B|||
2384|060|S|SIDE EFFECTS:  Changes in taste or diarrhea may occur. If either||
2384|061|S|of these effects lasts or gets worse, tell your doctor or||
2384|062|S|pharmacist promptly.||
2384|063|S|   Remember that this medication has been prescribed because your||
2384|064|S|doctor has judged that the benefit to you is greater than the||
2384|065|S|risk of side effects. Many people using this medication do not||
2384|066|S|have serious side effects.||
2384|067|S|   Tell your doctor right away if you have any serious side||
2384|068|S|effects, including: signs of liver problems (such as||
2384|069|S|nausea/vomiting that doesn't stop, loss of appetite,||
2384|070|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2384|071|S|   A very serious allergic reaction to this drug is rare.||
2384|072|S|However, get medical help right away if you notice any symptoms||
2384|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2384|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2384|075|S|breathing.||
2384|076|S|   This is not a complete list of possible side effects. If you||
2384|077|S|notice other effects not listed above, contact your doctor or||
2384|078|S|pharmacist.||
2384|079|S|   In the US -||
2384|080|S|   Call your doctor for medical advice about side effects. You||
2384|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2384|082|S|www.fda.gov/medwatch.||
2384|083|S|   In Canada - Call your doctor for medical advice about side||
2384|084|S|effects. You may report side effects to Health Canada at||
2384|085|S|1-866-234-2345.||
2384|086|B|||
2384|087|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2384|088|P|pharmacist if you are allergic to nirmatrelvir or ritonavir; or||
2384|089|P|if you have any other allergies. This product may contain||
2384|090|P|inactive ingredients, which can cause allergic reactions or other||
2384|091|P|problems. Talk to your pharmacist for more details.||
2384|092|P|   Before using this medication, tell your doctor or pharmacist||
2384|093|P|your medical history, especially of: kidney disease, liver||
2384|094|P|disease, HIV infection.||
2384|095|P|   To avoid spreading the virus, you should continue to take||
2384|096|P|precautions such as self-isolation, wearing a mask, social||
2384|097|P|distancing (physical distancing), washing hands, and not sharing||
2384|098|P|personal items.||
2384|099|P|   Before having surgery, tell your doctor or dentist about all||
2384|100|P|the products you use (including prescription drugs,||
2384|101|P|nonprescription drugs, and herbal products).||
2384|102|P|   During pregnancy, this product should be used only when||
2384|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
2384|104|P|   This medication passes into breast milk. Consult your doctor||
2384|105|P|before breastfeeding.||
2384|106|B|||
2384|107|I|DRUG INTERACTIONS:  See also Warning section.||
2384|108|I|   Drug interactions may change how your medications work or||
2384|109|I|increase your risk for serious side effects. This document does||
2384|110|I|not contain all possible drug interactions. Keep a list of all||
2384|111|I|the products you use (including prescription/nonprescription||
2384|112|I|drugs and herbal products) and share it with your doctor and||
2384|113|I|pharmacist. Do not start, stop, or change the dosage of any||
2384|114|I|medicines without your doctor's approval.||
2384|115|I|   A product that may interact with this drug is: orlistat.||
2384|116|I|   Nirmatrelvir/ritonavir can slow down or speed up the removal||
2384|117|I|of other medications from your body, which may affect how they||
2384|118|I|work. Examples of affected drugs include alfuzosin,||
2384|119|I|antiarrhythmics (such as amiodarone, flecainide, propafenone,||
2384|120|I|quinidine), azole antifungals (such as voriconazole), certain||
2384|121|I|benzodiazepines (midazolam, triazolam), certain "blood thinners"||
2384|122|I|(such as rivaroxaban, warfarin), eletriptan, drugs to treat||
2384|123|I|erectile dysfunction-ED or pulmonary hypertension (such as||
2384|124|I|avanafil, sildenafil), ergot alkaloids (such as||
2384|125|I|dihydroergotamine, ergonovine, ergotamine, methylergonovine),||
2384|126|I|lurasidone, certain opioid pain medications (such as fentanyl,||
2384|127|I|meperidine), pimozide, ranolazine, salmeterol, "statin"||
2384|128|I|cholesterol drugs (such as simvastatin, lovastatin), among||
2384|129|I|others.||
2384|130|I|   Other medications can affect the removal of||
2384|131|I|nirmatrelvir/ritonavir from your body, which may affect how this||
2384|132|I|medication works. Examples include apalutamide, butalbital,||
2384|133|I|encorafenib, enzalutamide, lumacaftor, mitotane, certain||
2384|134|I|rifamycins (such as rifampin, rifapentine), St. John's wort,||
2384|135|I|drugs used to treat seizures (such as carbamazepine,||
2384|136|I|phenobarbital, phenytoin), among others.||
2384|137|I|   This medication may decrease the effectiveness of hormonal||
2384|138|I|birth control (containing ethinyl estradiol) such as pills,||
2384|139|I|patch, or ring. This could cause pregnancy. Discuss with your||
2384|140|I|doctor or pharmacist if you should use reliable backup birth||
2384|141|I|control methods while using this medication. Also tell your||
2384|142|I|doctor if you have any new spotting or breakthrough bleeding,||
2384|143|I|because these may be signs that your birth control is not working||
2384|144|I|well.||
2384|145|B|||
2384|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2384|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2384|148|O|poison control center right away. US residents can call||
2384|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2384|150|B|||
2384|151|N|NOTES:  Do not share this medication with others.||
2384|152|N|   This medication has been prescribed for your current condition||
2384|153|N|only. Do not use it later for another infection unless your||
2384|154|N|doctor tells you to.||
2384|155|B|||
2384|156|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2384|157|D|remember. If it is more than 8 hours after the missed dose, skip||
2384|158|D|the missed dose. Take your next dose at the regular time. Do not||
2384|159|D|double the dose to catch up.||
2384|160|B|||
2384|161|R|STORAGE:  Store at room temperature away from light and moisture.||
2384|162|R|Do not store in the bathroom. Keep all medications away from||
2384|163|R|children and pets.||
2384|164|R|   Do not flush medications down the toilet or pour them into a||
2384|165|R|drain unless instructed to do so. Properly discard this product||
2384|166|R|when it is expired or no longer needed. Consult your pharmacist||
2384|167|R|or local waste disposal company.||
2384|168|B|||
2384|169|A|Information last revised February 2025.||
2384|170|A|Copyright(c) 2025 First Databank, Inc.||
2384|171|B|||
2385|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2385|002|Z|does NOT have all possible information about this product. This||
2385|003|Z|information does not assure that this product is safe, effective,||
2385|004|Z|or appropriate for you. This information is not individual||
2385|005|Z|medical advice and does not substitute for the advice of your||
2385|006|Z|health care professional. Always ask your health care||
2385|007|Z|professional for complete information about this product and your||
2385|008|Z|specific health needs.||
2385|009|B|||
2385|010|T|MOLNUPIRAVIR - ORAL||
2385|011|B|||
2385|012|U|USES:  Molnupiravir is a product that the FDA is allowing to be||
2385|013|U|given for emergency use to treat COVID-19. It is used by adults||
2385|014|U|18 years of age and older who have had mild to moderate symptoms||
2385|015|U|for no more than 5 days and are not hospitalized. To receive this||
2385|016|U|product you must also be at high risk for COVID-19 complications||
2385|017|U|due to older age, obesity, or ongoing medical conditions (such as||
2385|018|U|lung or heart disease or diabetes, among others). Talk to your||
2385|019|U|doctor about the risks and benefits of treatment with||
2385|020|U|molnupiravir.||
2385|021|U|   Molnupiravir works by preventing the growth of the virus that||
2385|022|U|causes COVID-19. More information about molnupiravir is available||
2385|023|U|from the FDA Fact Sheet for Patients, Parents, and Caregivers for||
2385|024|U|Emergency Use.||
2385|025|U|   There is limited information about how safe and effective||
2385|026|U|molnupiravir is for treating COVID-19. Study results show that||
2385|027|U|molnupiravir may help people who have coronavirus stay out of the||
2385|028|U|hospital. This product is not for use by people who are||
2385|029|U|hospitalized due to COVID-19.||
2385|030|U|   The information in this document reflects emerging data, which||
2385|031|U|is evolving and subject to reassessment. Users should be aware of||
2385|032|U|these considerations in their review of molnupiravir, and it is||
2385|033|U|always the responsibility of treating practitioners to exercise||
2385|034|U|independent judgement in making care decisions.||
2385|035|B|||
2385|036|H|HOW TO USE:  Take this medication by mouth with or without food||
2385|037|H|as directed by your doctor, usually every morning and evening, 12||
2385|038|H|hours apart, for 5 days. Swallow the capsules whole. Do not open,||
2385|039|H|break, or crush the capsules. Let your doctor know if you cannot||
2385|040|H|swallow the capsules whole. The dosage is based on your medical||
2385|041|H|condition and response to treatment.||
2385|042|H|   If you are giving this medication through a tube into the||
2385|043|H|stomach (nasogastric or orogastric tube), consult the FDA Fact||
2385|044|H|Sheet for Patients, Parents, and Caregivers for Emergency Use or||
2385|045|H|your health care professional for detailed instructions on how to||
2385|046|H|properly give it.||
2385|047|H|   Continue to take this medication for the full time prescribed,||
2385|048|H|even if symptoms disappear after a few days. Stopping the||
2385|049|H|medication too early may result in a return of the infection or||
2385|050|H|failure to protect you from the virus.||
2385|051|H|   Tell your doctor if your condition lasts or gets worse.||
2385|052|B|||
2385|053|S|SIDE EFFECTS:  Diarrhea, nausea, and dizziness may occur. If any||
2385|054|S|of these effects last or get worse, tell your health care||
2385|055|S|professional promptly.||
2385|056|S|   A very serious allergic reaction to this drug is rare.||
2385|057|S|However, get medical help right away if you notice any symptoms||
2385|058|S|of a serious allergic reaction, including: rash, itching/swelling||
2385|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2385|060|S|breathing.||
2385|061|S|   Information is limited and it is unknown at this time if||
2385|062|S|molnupiravir cause other serious side effects. This is not||
2385|063|S|necessarily a complete list of possible side effects.||
2385|064|S|   Contact your doctor for medical advice about side effects.||
2385|065|B|||
2385|066|P|PRECAUTIONS:  Before taking this medication, tell your doctor if||
2385|067|P|you have any allergies. This product may contain inactive||
2385|068|P|ingredients which can cause allergic reactions or other problems.||
2385|069|P|   Limited information is known at this time about other medical||
2385|070|P|conditions that may affect how molnupiravir work, or how||
2385|071|P|molnupiravir may affect other medical conditions.||
2385|072|P|   Before using this medication, tell your doctor or pharmacist||
2385|073|P|your medical history.||
2385|074|P|   To avoid spreading the virus, you should continue to take||
2385|075|P|precautions such as self-isolation, wearing a mask, social||
2385|076|P|distancing (physical distancing), washing hands, and not sharing||
2385|077|P|personal items.||
2385|078|P|   Tell your doctor if you are pregnant or plan to become||
2385|079|P|pregnant. You should not become pregnant while using||
2385|080|P|molnupiravir. Molnupiravir may harm an unborn baby. Your doctor||
2385|081|P|may order a pregnancy test before you start this medication.||
2385|082|P|Women using this medication should ask about reliable forms of||
2385|083|P|birth control during treatment and for 4 days after the last||
2385|084|P|dose. Men using this medication should ask about reliable forms||
2385|085|P|of birth control during treatment and for 3 months after the last||
2385|086|P|dose. If you or your partner becomes pregnant, talk to your||
2385|087|P|doctor right away about the risks and benefits of this||
2385|088|P|medication.||
2385|089|P|   It is unknown if molnupiravir passes into breast milk. Because||
2385|090|P|of the possible risk to the infant, breastfeeding is not||
2385|091|P|recommended while using this medication and for 4 days after the||
2385|092|P|last dose. Consult your doctor before breastfeeding.||
2385|093|B|||
2385|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2385|095|I|medications work or increase your risk for serious side effects.||
2385|096|I|Information is limited and it is unknown at this time if||
2385|097|I|molnupiravir has drug interactions. This document does not||
2385|098|I|contain all possible drug interactions. Keep a list of all the||
2385|099|I|products you use (including prescription/nonprescription drugs||
2385|100|I|and herbal products) and share it with your doctor and||
2385|101|I|pharmacist. Do not start, stop, or change the dosage of any||
2385|102|I|medicines without your doctor's approval.||
2385|103|B|||
2385|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2385|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2385|106|O|poison control center right away. US residents can call||
2385|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2385|108|B|||
2385|109|N|NOTES:  Do not share this medication with others.||
2385|110|N|   This medication has been prescribed for your current condition||
2385|111|N|only. Do not use it later for another infection unless your||
2385|112|N|doctor tells you to.||
2385|113|B|||
2385|114|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2385|115|D|remember. If it is more than 10 hours after the missed dose, skip||
2385|116|D|the missed dose. Take your next dose at the regular time. Do not||
2385|117|D|double the dose to catch up.||
2385|118|B|||
2385|119|R|STORAGE:  Store at room temperature away from light and moisture.||
2385|120|R|Do not store in the bathroom. Keep all medications away from||
2385|121|R|children and pets.||
2385|122|R|   Do not flush medications down the toilet or pour them into a||
2385|123|R|drain unless instructed to do so. Properly discard this product||
2385|124|R|when it is expired or no longer needed. Consult your pharmacist||
2385|125|R|or local waste disposal company.||
2385|126|B|||
2385|127|A|Information last revised May 2024.||
2385|128|A|Copyright(c) 2025 First Databank, Inc.||
2385|129|B|||
2386|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2386|002|Z|does NOT have all possible information about this product. This||
2386|003|Z|information does not assure that this product is safe, effective,||
2386|004|Z|or appropriate for you. This information is not individual||
2386|005|Z|medical advice and does not substitute for the advice of your||
2386|006|Z|health care professional. Always ask your health care||
2386|007|Z|professional for complete information about this product and your||
2386|008|Z|specific health needs.||
2386|009|B|||
2386|010|T|CABOTEGRAVIR EXTENDED-RELEASE - INJECTION||
2386|011|F|(KA-boe-TEG-ra-vir)||
2386|012|B|||
2386|013|C|COMMON BRAND NAME(S): Apretude||
2386|014|B|||
2386|015|W|WARNING:  Before starting this medication, you must first get||
2386|016|W|tested to be sure you are HIV negative. Your doctor will order||
2386|017|W|lab tests before starting this medication and during treatment to||
2386|018|W|make sure you do not have HIV infection. Using this product will||
2386|019|W|not always prevent HIV infection. To get the most benefit, use||
2386|020|W|this medication exactly as directed and follow all prevention||
2386|021|W|actions (see also Uses section). Some HIV tests can miss HIV||
2386|022|W|infection in a person who has recently become infected. Tell your||
2386|023|W|doctor right away if you have any signs of HIV infection such as||
2386|024|W|a sore throat that doesn't go away, tiredness, fever, night||
2386|025|W|sweats, rash, diarrhea, joint/muscle aches, enlarged lymph nodes.||
2386|026|W|If you become HIV positive, you will need to take other||
2386|027|W|medications to treat HIV. If you have HIV and receive only this||
2386|028|W|medication, your HIV may become harder to treat.||
2386|029|B|||
2386|030|U|USES:  This product is used to help reduce the risk of getting||
2386|031|U|HIV infection. Cabotegravir belongs to a class of drugs known as||
2386|032|U|integrase inhibitors. It works by blocking the virus from growing||
2386|033|U|and infecting more cells. This product does not protect against||
2386|034|U|other sexually transmitted infections (such as gonorrhea,||
2386|035|U|syphilis).||
2386|036|U|   When cabotegravir is given in combination with rilpivirine, it||
2386|037|U|is used to help control HIV infection.||
2386|038|U|   To decrease your risk of getting HIV and other sexually||
2386|039|U|transmitted infections, use an effective barrier method (latex or||
2386|040|U|polyurethane condoms/dental dams) during sexual activity as||
2386|041|U|directed by your doctor. Do not share personal items (such as||
2386|042|U|needles/syringes, toothbrushes, and razors) that may have||
2386|043|U|contacted blood or other body fluids. Consult your doctor or||
2386|044|U|pharmacist for more details.||
2386|045|B|||
2386|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2386|047|H|from your pharmacist before you start using cabotegravir and each||
2386|048|H|time you get a refill. If you have any questions, ask your doctor||
2386|049|H|or pharmacist.||
2386|050|H|   Before starting treatment with this product, you must first||
2386|051|H|get tested to make sure you do not already have HIV infection. Do||
2386|052|H|not receive this medication unless you are confirmed to be HIV||
2386|053|H|negative.||
2386|054|H|   To see how well you can take this medication, your doctor may||
2386|055|H|have you take the form of cabotegravir taken by mouth for one||
2386|056|H|month (at least 28 days) before starting treatment with this form||
2386|057|H|of cabotegravir. Carefully follow your doctor's directions for||
2386|058|H|taking all your medications.||
2386|059|H|   This product is given by injection into a muscle as directed||
2386|060|H|by your doctor, usually once every month for the first 2 months,||
2386|061|H|then once every 2 months. It is given by injection into a buttock||
2386|062|H|muscle by a health care professional. The dosage is based on your||
2386|063|H|medical condition and response to treatment.||
2386|064|H|   It is very important to keep using this medication exactly as||
2386|065|H|prescribed by your doctor. To help you remember, mark your||
2386|066|H|calendar with a reminder. If you miss or will miss a planned||
2386|067|H|injection by more than 7 days, tell your health care professional||
2386|068|H|right away to get directions for your continued HIV prevention.||
2386|069|B|||
2386|070|S|SIDE EFFECTS:  Injection site pain/discomfort, swelling, redness,||
2386|071|S|itching, bruising, or a hardened mass or lump may occur.||
2386|072|S|Diarrhea, headache, dizziness, tiredness, and trouble sleeping||
2386|073|S|may also occur. If any of these effects last or get worse, tell||
2386|074|S|your doctor or pharmacist promptly.||
2386|075|S|   Remember that this medication has been prescribed because your||
2386|076|S|doctor has judged that the benefit to you is greater than the||
2386|077|S|risk of side effects. Many people using this medication do not||
2386|078|S|have serious side effects.||
2386|079|S|   Tell your doctor right away if you have any serious side||
2386|080|S|effects, including: signs of liver problems (such as||
2386|081|S|nausea/vomiting that doesn't stop, loss of appetite,||
2386|082|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2386|083|S|mental/mood changes (such as depression, thoughts of suicide).||
2386|084|S|   A very serious allergic reaction to this drug is rare.||
2386|085|S|However, get medical help right away if you notice any symptoms||
2386|086|S|of a serious allergic reaction, including: rash, itching/swelling||
2386|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2386|088|S|breathing.||
2386|089|S|   This is not a complete list of possible side effects. If you||
2386|090|S|notice other effects not listed above, contact your doctor or||
2386|091|S|pharmacist.||
2386|092|S|   In the US -||
2386|093|S|   Call your doctor for medical advice about side effects. You||
2386|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2386|095|S|www.fda.gov/medwatch.||
2386|096|S|   In Canada - Call your doctor for medical advice about side||
2386|097|S|effects. You may report side effects to Health Canada at||
2386|098|S|1-866-234-2345.||
2386|099|B|||
2386|100|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2386|101|P|pharmacist if you are allergic to cabotegravir; or if you have||
2386|102|P|any other allergies. This product may contain inactive||
2386|103|P|ingredients, which can cause allergic reactions or other||
2386|104|P|problems. Talk to your pharmacist for more details.||
2386|105|P|   Before using this medication, tell your doctor or pharmacist||
2386|106|P|your medical history, especially of: liver disease, mental/mood||
2386|107|P|disorders (such as depression).||
2386|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2386|109|P|can make you more dizzy. Do not drive, use machinery, or do||
2386|110|P|anything that needs alertness until you can do it safely. Limit||
2386|111|P|alcoholic beverages. Talk to your doctor if you are using||
2386|112|P|marijuana (cannabis).||
2386|113|P|   Before having surgery, tell your doctor or dentist about all||
2386|114|P|the products you use (including prescription drugs,||
2386|115|P|nonprescription drugs, and herbal products).||
2386|116|P|   During pregnancy, this medication should be used only when||
2386|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
2386|118|P|   It is unknown if this medication passes into breast milk.||
2386|119|P|Consult your doctor before breastfeeding.||
2386|120|B|||
2386|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2386|122|I|medications work or increase your risk for serious side effects.||
2386|123|I|This document does not contain all possible drug interactions.||
2386|124|I|Keep a list of all the products you use (including||
2386|125|I|prescription/nonprescription drugs and herbal products) and share||
2386|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
2386|127|I|the dosage of any medicines without your doctor's approval.||
2386|128|I|   Do not use this medication with other products that contain||
2386|129|I|cabotegravir.||
2386|130|I|   Other medications can affect the removal of cabotegravir from||
2386|131|I|your body, which may affect how this product works. Examples||
2386|132|I|include efavirenz, rifamycins (such as rifampin, rifapentine),||
2386|133|I|certain drugs used to treat seizures (such as carbamazepine,||
2386|134|I|oxcarbazepine, phenobarbital, phenytoin, primidone), among||
2386|135|I|others.||
2386|136|I|   This medication can slow down the removal of other medications||
2386|137|I|from your body, which may affect how they work. An example of an||
2386|138|I|affected drug is ketorolac, among others.||
2386|139|B|||
2386|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2386|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2386|142|O|poison control center right away. US residents can call||
2386|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2386|144|O|Symptoms of overdose may include: fast/irregular heartbeat,||
2386|145|O|severe dizziness, fainting.||
2386|146|B|||
2386|147|N|NOTES:  Lab and/or medical tests (such as HIV tests, liver||
2386|148|N|function) should be done while you are using this medication.||
2386|149|N|Keep all medical and lab appointments. Consult your doctor for||
2386|150|N|more details.||
2386|151|B|||
2386|152|D|MISSED DOSE:  It is important to get each dose of this medication||
2386|153|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2386|154|D|right away for a new dosing schedule.||
2386|155|B|||
2386|156|R|STORAGE:  Not applicable. This product is given in a hospital or||
2386|157|R|clinic or doctor's office and will not be stored at home.||
2386|158|B|||
2386|159|A|Information last revised July 2025.||
2386|160|A|Copyright(c) 2025 First Databank, Inc.||
2386|161|B|||
2387|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2387|002|Z|does NOT have all possible information about this product. This||
2387|003|Z|information does not assure that this product is safe, effective,||
2387|004|Z|or appropriate for you. This information is not individual||
2387|005|Z|medical advice and does not substitute for the advice of your||
2387|006|Z|health care professional. Always ask your health care||
2387|007|Z|professional for complete information about this product and your||
2387|008|Z|specific health needs.||
2387|009|B|||
2387|010|T|EFGARTIGIMOD ALFA - INJECTION||
2387|011|F|(EF-gar-TIG-i-mod)||
2387|012|B|||
2387|013|C|COMMON BRAND NAME(S): Vyvgart||
2387|014|B|||
2387|015|U|USES:  Efgartigimod alfa is used to treat a certain muscle||
2387|016|U|condition (generalized myasthenia gravis). It may help to improve||
2387|017|U|symptoms of muscle weakness.||
2387|018|B|||
2387|019|H|HOW TO USE:  This medication is given by injection into a vein by||
2387|020|H|a health care professional as directed by your doctor. It is||
2387|021|H|usually given over one hour, once weekly, for 4 weeks. The dosage||
2387|022|H|and additional treatment cycles are based on your weight, medical||
2387|023|H|condition, and response to treatment.||
2387|024|H|   Infusion reactions may happen during the infusion of this drug||
2387|025|H|and up to one hour afterward. Tell your doctor right away if you||
2387|026|H|have symptoms of infusion reactions such as chills,||
2387|027|H|chest/stomach/back pain, or shivering.||
2387|028|H|   Tell your doctor if your condition does not get better or if||
2387|029|H|it gets worse.||
2387|030|B|||
2387|031|S|SIDE EFFECTS:  See also How to Use section.||
2387|032|S|   Muscle pain or numb/tingling skin may occur. If either of||
2387|033|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2387|034|S|promptly.||
2387|035|S|   Remember that this medication has been prescribed because your||
2387|036|S|doctor has judged that the benefit to you is greater than the||
2387|037|S|risk of side effects. Many people using this medication do not||
2387|038|S|have serious side effects.||
2387|039|S|   This medication may lower your ability to fight infections.||
2387|040|S|This may make you more likely to get a serious infection or make||
2387|041|S|any infection you have worse. Tell your doctor right away if you||
2387|042|S|have any signs of infection (such as sore throat that doesn't go||
2387|043|S|away, fever, chills, painful/burning urination).||
2387|044|S|   A very serious allergic reaction to this drug is rare.||
2387|045|S|However, get medical help right away if you notice any symptoms||
2387|046|S|of a serious allergic reaction, including: rash, itching/swelling||
2387|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2387|048|S|breathing.||
2387|049|S|   This is not a complete list of possible side effects. If you||
2387|050|S|notice other effects not listed above, contact your doctor or||
2387|051|S|pharmacist.||
2387|052|S|   In the US -||
2387|053|S|   Call your doctor for medical advice about side effects. You||
2387|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2387|055|S|www.fda.gov/medwatch.||
2387|056|S|   In Canada - Call your doctor for medical advice about side||
2387|057|S|effects. You may report side effects to Health Canada at||
2387|058|S|1-866-234-2345.||
2387|059|B|||
2387|060|P|PRECAUTIONS:  Before using efgartigimod alfa, tell your doctor or||
2387|061|P|pharmacist if you are allergic to it; or if you have any other||
2387|062|P|allergies. This product may contain inactive ingredients, which||
2387|063|P|can cause allergic reactions or other problems. Talk to your||
2387|064|P|pharmacist for more details.||
2387|065|P|   Before using this medication, tell your doctor or pharmacist||
2387|066|P|your medical history, especially of: current/recent infection.||
2387|067|P|   Efgartigimod alfa can make you more likely to get infections||
2387|068|P|or may make current infections worse. Stay away from anyone who||
2387|069|P|has an infection that may easily spread (such as chickenpox,||
2387|070|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2387|071|P|exposed to an infection or for more details.||
2387|072|P|   Tell your health care professional that you are using||
2387|073|P|efgartigimod alfa before having any immunizations/vaccinations.||
2387|074|P|Avoid contact with people who have recently received live||
2387|075|P|vaccines (such as flu vaccine inhaled through the nose).||
2387|076|P|   Before having surgery, tell your doctor or dentist about all||
2387|077|P|the products you use (including prescription drugs,||
2387|078|P|nonprescription drugs, and herbal products).||
2387|079|P|   During pregnancy, this medication should be used only when||
2387|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
2387|081|P|Mothers who have used this medication during pregnancy should ask||
2387|082|P|a doctor about immunizations/vaccinations for their newborn||
2387|083|P|babies.||
2387|084|P|   It is unknown if this drug passes into breast milk. Consult||
2387|085|P|your doctor before breastfeeding.||
2387|086|B|||
2387|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2387|088|I|medications work or increase your risk for serious side effects.||
2387|089|I|This document does not contain all possible drug interactions.||
2387|090|I|Keep a list of all the products you use (including||
2387|091|I|prescription/nonprescription drugs and herbal products) and share||
2387|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
2387|093|I|the dosage of any medicines without your doctor's approval.||
2387|094|B|||
2387|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2387|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2387|097|O|poison control center right away. US residents can call||
2387|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2387|099|B|||
2387|100|N|NOTES:  Lab and/or medical tests (such as complete blood count)||
2387|101|N|should be done while you are using this medication. Keep all||
2387|102|N|medical and lab appointments. Consult your doctor for more||
2387|103|N|details.||
2387|104|B|||
2387|105|D|MISSED DOSE:  It is important to get each dose of this medication||
2387|106|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2387|107|D|right away for a new dosing schedule.||
2387|108|B|||
2387|109|R|STORAGE:  Not applicable. This medication is given in a clinic||
2387|110|R|and will not be stored at home.||
2387|111|B|||
2387|112|M|MEDICAL ALERT:  Your condition can cause complications in a||
2387|113|M|medical emergency. For information about enrolling in MedicAlert,||
2387|114|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2387|115|B|||
2387|116|A|Information last revised April 2025.||
2387|117|A|Copyright(c) 2025 First Databank, Inc.||
2387|118|B|||
2388|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2388|002|Z|does NOT have all possible information about this product. This||
2388|003|Z|information does not assure that this product is safe, effective,||
2388|004|Z|or appropriate for you. This information is not individual||
2388|005|Z|medical advice and does not substitute for the advice of your||
2388|006|Z|health care professional. Always ask your health care||
2388|007|Z|professional for complete information about this product and your||
2388|008|Z|specific health needs.||
2388|009|B|||
2388|010|T|INCLISIRAN - INJECTION||
2388|011|F|(IN-kli-SIR-an)||
2388|012|B|||
2388|013|C|COMMON BRAND NAME(S): Leqvio||
2388|014|B|||
2388|015|U|USES:  Inclisiran is used to help lower "bad" cholesterol (LDL)||
2388|016|U|in the blood. It should be used along with other LDL-lowering||
2388|017|U|medications (such as "statin" drugs) and a proper diet.||
2388|018|U|Inclisiran works by improving how well your body gets rid of LDL||
2388|019|U|cholesterol.||
2388|020|U|   In addition to eating a proper diet (such as a||
2388|021|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
2388|022|U|help this medication work better include exercising, losing||
2388|023|U|weight if overweight, and stopping smoking. Consult your doctor||
2388|024|U|for more details.||
2388|025|B|||
2388|026|H|HOW TO USE:  This medication is given by injection into the skin||
2388|027|H|by a health care professional as directed by your doctor. You||
2388|028|H|will receive one dose, followed by a second dose 3 months later.||
2388|029|H|Then this medication is given every 6 months.||
2388|030|H|   Use this medication regularly to get the most benefit from it.||
2388|031|H|To help you remember, mark your calendar with a reminder.||
2388|032|B|||
2388|033|S|SIDE EFFECTS:  Redness, pain, or bruising at the injection site||
2388|034|S|may occur. If any of these effects last or get worse, tell your||
2388|035|S|doctor or pharmacist promptly.||
2388|036|S|   Remember that this medication has been prescribed because your||
2388|037|S|doctor has judged that the benefit to you is greater than the||
2388|038|S|risk of side effects. Many people using this medication do not||
2388|039|S|have serious side effects.||
2388|040|S|   A very serious allergic reaction to this drug is rare.||
2388|041|S|However, get medical help right away if you notice any symptoms||
2388|042|S|of a serious allergic reaction, including: rash, itching/swelling||
2388|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2388|044|S|breathing.||
2388|045|S|   This is not a complete list of possible side effects. If you||
2388|046|S|notice other effects not listed above, contact your doctor or||
2388|047|S|pharmacist.||
2388|048|S|   In the US -||
2388|049|S|   Call your doctor for medical advice about side effects. You||
2388|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2388|051|S|www.fda.gov/medwatch.||
2388|052|S|   In Canada - Call your doctor for medical advice about side||
2388|053|S|effects. You may report side effects to Health Canada at||
2388|054|S|1-866-234-2345.||
2388|055|B|||
2388|056|P|PRECAUTIONS:  Before using inclisiran, tell your doctor or||
2388|057|P|pharmacist if you are allergic to it; or if you have any other||
2388|058|P|allergies. This product may contain inactive ingredients, which||
2388|059|P|can cause allergic reactions or other problems. Talk to your||
2388|060|P|pharmacist for more details.||
2388|061|P|   Before using this medication, tell your doctor or pharmacist||
2388|062|P|your medical history.||
2388|063|P|   Before having surgery, tell your doctor or dentist about all||
2388|064|P|the products you use (including prescription drugs,||
2388|065|P|nonprescription drugs, and herbal products).||
2388|066|P|   During pregnancy, this medication should be used only when||
2388|067|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2388|068|P|benefits with your doctor.||
2388|069|P|   It is unknown if this medication passes into breast milk.||
2388|070|P|Consult your doctor before breastfeeding.||
2388|071|B|||
2388|072|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2388|073|I|medications work or increase your risk for serious side effects.||
2388|074|I|This document does not contain all possible drug interactions.||
2388|075|I|Keep a list of all the products you use (including||
2388|076|I|prescription/nonprescription drugs and herbal products) and share||
2388|077|I|it with your doctor and pharmacist. Do not start, stop, or change||
2388|078|I|the dosage of any medicines without your doctor's approval.||
2388|079|B|||
2388|080|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2388|081|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2388|082|O|poison control center right away. US residents can call||
2388|083|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2388|084|B|||
2388|085|N|NOTES:  Do not share this medication with others.||
2388|086|N|   Lab and/or medical tests (such as LDL cholesterol levels)||
2388|087|N|should be done while you are using this medication. Keep all||
2388|088|N|medical and lab appointments.||
2388|089|B|||
2388|090|D|MISSED DOSE:  It is important to get each dose of this medication||
2388|091|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2388|092|D|right away for a new dosing schedule. Do not double the dose to||
2388|093|D|catch up.||
2388|094|B|||
2388|095|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2388|096|R|doctor's office and will not be stored at home.||
2388|097|B|||
2388|098|A|Information last revised October 2024.||
2388|099|A|Copyright(c) 2025 First Databank, Inc.||
2388|100|B|||
2389|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2389|002|Z|does NOT have all possible information about this product. This||
2389|003|Z|information does not assure that this product is safe, effective,||
2389|004|Z|or appropriate for you. This information is not individual||
2389|005|Z|medical advice and does not substitute for the advice of your||
2389|006|Z|health care professional. Always ask your health care||
2389|007|Z|professional for complete information about this product and your||
2389|008|Z|specific health needs.||
2389|009|B|||
2389|010|T|TRALOKINUMAB - INJECTION||
2389|011|F|(TRAL-o-KIN-ue-mab)||
2389|012|B|||
2389|013|C|COMMON BRAND NAME(S): Adbry||
2389|014|B|||
2389|015|U|USES:  This medication is used to treat a skin condition called||
2389|016|U|eczema (atopic dermatitis). Tralokinumab belongs to a class of||
2389|017|U|drugs known as monoclonal antibodies. It works by blocking a||
2389|018|U|certain natural protein in your body (interleukin-13) that may||
2389|019|U|cause inflammation and swelling in eczema.||
2389|020|B|||
2389|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2389|022|H|Instructions for Use if available from your pharmacist before you||
2389|023|H|start using tralokinumab and each time you get a refill. Ask your||
2389|024|H|health care professional how to prepare and use this medication.||
2389|025|H|If you have any questions, ask your doctor or pharmacist.||
2389|026|H|   Inject this medication under your skin as directed by your||
2389|027|H|doctor, usually once every 2 or 4 weeks. The injection is given||
2389|028|H|in the upper arms, thighs, or abdomen (except for a 2-inch area||
2389|029|H|around your belly button). The dosage is based on your medical||
2389|030|H|condition and response to treatment.||
2389|031|H|   Depending on your product, take the medication out of the||
2389|032|H|refrigerator at least 30 to 45 minutes before you inject it to||
2389|033|H|allow it to reach room temperature. Do not warm up this||
2389|034|H|medication any other way (for example, do not heat it in the||
2389|035|H|microwave, place it in hot water, or leave it in direct||
2389|036|H|sunlight). Do not shake the medication. Before using, check this||
2389|037|H|product for cloudiness, particles, or discoloration. If you see||
2389|038|H|any of these things, do not use the liquid. Before injecting each||
2389|039|H|dose, clean the skin you are going to inject into (the injection||
2389|040|H|site) with rubbing alcohol. Change the injection site each time||
2389|041|H|to lessen injury under the skin. Do not inject into skin that is||
2389|042|H|tender, damaged, bruised, or scarred. To lessen bruising, do not||
2389|043|H|rub the injection site after a shot. Learn how to store and||
2389|044|H|discard medical supplies safely.||
2389|045|H|   Use this medication regularly to get the most benefit from it.||
2389|046|H|To help you remember, mark your calendar with a reminder.||
2389|047|H|   Tell your doctor if your condition does not get better or if||
2389|048|H|it gets worse.||
2389|049|B|||
2389|050|S|SIDE EFFECTS:  Redness, swelling, or pain at the injection site||
2389|051|S|may occur. Swelling/redness/itching of the eyes or eyelids may||
2389|052|S|also occur. If any of these effects last or get worse, tell your||
2389|053|S|doctor or pharmacist promptly.||
2389|054|S|   Remember that this medication has been prescribed because your||
2389|055|S|doctor has judged that the benefit to you is greater than the||
2389|056|S|risk of side effects. Many people using this medication do not||
2389|057|S|have serious side effects.||
2389|058|S|   Tell your doctor right away if you have any serious side||
2389|059|S|effects, including: signs of infection (such as sore throat that||
2389|060|S|doesn't go away, fever), other eye problems (such as eye pain,||
2389|061|S|changes in vision).||
2389|062|S|   A very serious allergic reaction to this drug is rare.||
2389|063|S|However, get medical help right away if you notice any symptoms||
2389|064|S|of a serious allergic reaction, including: rash, itching/swelling||
2389|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2389|066|S|breathing.||
2389|067|S|   This is not a complete list of possible side effects. If you||
2389|068|S|notice other effects not listed above, contact your doctor or||
2389|069|S|pharmacist.||
2389|070|S|   In the US -||
2389|071|S|   Call your doctor for medical advice about side effects. You||
2389|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2389|073|S|www.fda.gov/medwatch.||
2389|074|S|   In Canada - Call your doctor for medical advice about side||
2389|075|S|effects. You may report side effects to Health Canada at||
2389|076|S|1-866-234-2345.||
2389|077|B|||
2389|078|P|PRECAUTIONS:  Before using tralokinumab, tell your doctor or||
2389|079|P|pharmacist if you are allergic to it; or if you have any other||
2389|080|P|allergies. This product may contain inactive ingredients, which||
2389|081|P|can cause allergic reactions or other problems. Talk to your||
2389|082|P|pharmacist for more details.||
2389|083|P|   Before using this medication, tell your doctor or pharmacist||
2389|084|P|your medical history, especially of: a certain type of infection||
2389|085|P|(helminth).||
2389|086|P|   Tell your health care professional that you are using||
2389|087|P|tralokinumab before having any immunizations/vaccinations.||
2389|088|P|   Before having surgery, tell your doctor or dentist about all||
2389|089|P|the products you use (including prescription drugs,||
2389|090|P|nonprescription drugs, and herbal products).||
2389|091|P|   During pregnancy, this medication should be used only when||
2389|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
2389|093|P|   It is unknown if this medication passes into breast milk.||
2389|094|P|Consult your doctor before breastfeeding.||
2389|095|B|||
2389|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2389|097|I|medications work or increase your risk for serious side effects.||
2389|098|I|This document does not contain all possible drug interactions.||
2389|099|I|Keep a list of all the products you use (including||
2389|100|I|prescription/nonprescription drugs and herbal products) and share||
2389|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
2389|102|I|the dosage of any medicines without your doctor's approval.||
2389|103|B|||
2389|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2389|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2389|106|O|poison control center right away. US residents can call||
2389|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2389|108|B|||
2389|109|N|NOTES:  Do not share this medication with others.||
2389|110|B|||
2389|111|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2389|112|D|If it is near the time of the next dose, skip the missed dose.||
2389|113|D|Use your next dose at the regular time. Do not double the dose to||
2389|114|D|catch up.||
2389|115|B|||
2389|116|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2389|117|R|medication in the original carton to protect from light. This||
2389|118|R|medication may also be stored at room temperature if needed. If||
2389|119|R|the medication is stored at room temperature, do not put it back||
2389|120|R|in the refrigerator and discard after 14 days. Keep all||
2389|121|R|medications away from children and pets.||
2389|122|R|   Do not flush medications down the toilet or pour them into a||
2389|123|R|drain unless instructed to do so. Properly discard this product||
2389|124|R|when it is expired or no longer needed. Consult your pharmacist||
2389|125|R|or local waste disposal company.||
2389|126|B|||
2389|127|A|Information last revised April 2025.||
2389|128|A|Copyright(c) 2025 First Databank, Inc.||
2389|129|B|||
2390|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2390|002|Z|does NOT have all possible information about this product. This||
2390|003|Z|information does not assure that this product is safe, effective,||
2390|004|Z|or appropriate for you. This information is not individual||
2390|005|Z|medical advice and does not substitute for the advice of your||
2390|006|Z|health care professional. Always ask your health care||
2390|007|Z|professional for complete information about this product and your||
2390|008|Z|specific health needs.||
2390|009|B|||
2390|010|T|BILASTINE DISPERSIBLE TABLET - ORAL||
2390|011|B|||
2390|012|U|USES:  This medication is an antihistamine used to relieve||
2390|013|U|allergy symptoms such as watery eyes, runny nose, itching||
2390|014|U|eyes/nose, and sneezing. It is also used to relieve itching and||
2390|015|U|hives. It works by blocking a certain natural substance||
2390|016|U|(histamine) that your body makes during an allergic reaction.||
2390|017|U|   Bilastine does not prevent hives or prevent/treat a serious||
2390|018|U|allergic reaction (such as anaphylaxis). If your doctor has||
2390|019|U|prescribed epinephrine to treat allergic reactions, always carry||
2390|020|U|your epinephrine injector with you. Do not use bilastine in place||
2390|021|U|of your epinephrine.||
2390|022|B|||
2390|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2390|024|H|from your pharmacist before you start taking bilastine and each||
2390|025|H|time you get a refill. If you have any questions, ask your doctor||
2390|026|H|or pharmacist.||
2390|027|H|   Take this medication by mouth on an empty stomach (at least 1||
2390|028|H|hour before or 2 hours after food, grapefruit juice, or other||
2390|029|H|fruit juices) as directed by your doctor, usually once a day.||
2390|030|H|Taking this medication with food, grapefruit juice, or other||
2390|031|H|fruit juices may make this medication work less well.||
2390|032|H|   Do not break, chew, or crush the tablets. Do not remove any||
2390|033|H|tablets from the blister pack until you are ready to take your||
2390|034|H|dose. Doing so could make it work less well.||
2390|035|H|   With clean and dry hands, open the blister pack and place the||
2390|036|H|tablet on your tongue. The tablet will quickly dissolve and can||
2390|037|H|be swallowed with your saliva.||
2390|038|H|   The tablet may also be dissolved in a teaspoon of water before||
2390|039|H|taking/giving it by mouth. Make sure that none of the tablet||
2390|040|H|remains in the spoon after taking it. Only dissolve the tablet in||
2390|041|H|water. Do not use grapefruit juice or any other fruit juices.||
2390|042|H|   Use this medication regularly to get the most benefit from it.||
2390|043|H|To help you remember, take it at the same time each day. Do not||
2390|044|H|increase your dose or take this drug more often than directed.||
2390|045|H|   Tell your doctor if your condition does not get better or if||
2390|046|H|it gets worse.||
2390|047|B|||
2390|048|S|SIDE EFFECTS:  This drug usually has no side effects. If you have||
2390|049|S|any unusual effects, contact your doctor or pharmacist promptly.||
2390|050|S|   Remember that this medication has been prescribed because your||
2390|051|S|doctor has judged that the benefit to you is greater than the||
2390|052|S|risk of side effects. Many people using this medication do not||
2390|053|S|have serious side effects.||
2390|054|S|   Get medical help right away if you have any very serious side||
2390|055|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2390|056|S|fainting.||
2390|057|S|   A very serious allergic reaction to this drug is rare.||
2390|058|S|However, get medical help right away if you notice any symptoms||
2390|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2390|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2390|061|S|breathing.||
2390|062|S|   This is not a complete list of possible side effects. If you||
2390|063|S|notice other effects not listed above, contact your doctor or||
2390|064|S|pharmacist.||
2390|065|S|   In the US -||
2390|066|S|   Call your doctor for medical advice about side effects. You||
2390|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2390|068|S|www.fda.gov/medwatch.||
2390|069|S|   In Canada - Call your doctor for medical advice about side||
2390|070|S|effects. You may report side effects to Health Canada at||
2390|071|S|1-866-234-2345.||
2390|072|B|||
2390|073|P|PRECAUTIONS:  Before taking bilastine, tell your doctor or||
2390|074|P|pharmacist if you are allergic to it; or if you have any other||
2390|075|P|allergies. This product may contain inactive ingredients, which||
2390|076|P|can cause allergic reactions or other problems. Talk to your||
2390|077|P|pharmacist for more details.||
2390|078|P|   Before using this medication, tell your doctor or pharmacist||
2390|079|P|your medical history, especially of: kidney disease.||
2390|080|P|   This drug may rarely make you drowsy. Alcohol or marijuana||
2390|081|P|(cannabis) can make you more drowsy. Do not drive, use machinery,||
2390|082|P|or do anything that needs alertness until you can do it safely.||
2390|083|P|Limit alcoholic beverages. Talk to your doctor if you are using||
2390|084|P|marijuana (cannabis).||
2390|085|P|   Bilastine may cause a condition that affects the heart rhythm||
2390|086|P|(QT prolongation). QT prolongation can rarely cause serious||
2390|087|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2390|088|P|as severe dizziness, fainting) that need medical attention right||
2390|089|P|away.||
2390|090|P|   The risk of QT prolongation may be increased if you have||
2390|091|P|certain medical conditions or are taking other drugs that may||
2390|092|P|cause QT prolongation. Before using bilastine, tell your doctor||
2390|093|P|or pharmacist of all the drugs you take and if you have any of||
2390|094|P|the following conditions: certain heart problems (heart failure,||
2390|095|P|slow heartbeat, QT prolongation in the EKG), family history of||
2390|096|P|certain heart problems (QT prolongation in the EKG, sudden||
2390|097|P|cardiac death).||
2390|098|P|   Low levels of potassium or magnesium in the blood may also||
2390|099|P|increase your risk of QT prolongation. This risk may increase if||
2390|100|P|you use certain drugs (such as diuretics/"water pills") or if you||
2390|101|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2390|102|P|Talk to your doctor about using bilastine safely.||
2390|103|P|   Dissolving tablets may contain sugar and/or aspartame. Caution||
2390|104|P|is advised if you have diabetes, liver disease, phenylketonuria||
2390|105|P|(PKU), or any other condition that requires you to limit or avoid||
2390|106|P|these substances in your diet. Ask your doctor or pharmacist||
2390|107|P|about using this product safely.||
2390|108|P|   Before having surgery, tell your doctor or dentist about all||
2390|109|P|the products you use (including prescription drugs,||
2390|110|P|nonprescription drugs, and herbal products).||
2390|111|P|   Older adults may be more sensitive to the side effects of this||
2390|112|P|drug, especially QT prolongation (see above).||
2390|113|P|   During pregnancy, this medication should be used only when||
2390|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
2390|115|P|   It is unknown if this medication passes into breast milk.||
2390|116|P|Consult your doctor before breastfeeding.||
2390|117|B|||
2390|118|I|DRUG INTERACTIONS:  See also How to Use section.||
2390|119|I|   Drug interactions may change how your medications work or||
2390|120|I|increase your risk for serious side effects. This document does||
2390|121|I|not contain all possible drug interactions. Keep a list of all||
2390|122|I|the products you use (including prescription/nonprescription||
2390|123|I|drugs and herbal products) and share it with your doctor and||
2390|124|I|pharmacist. Do not start, stop, or change the dosage of any||
2390|125|I|medicines without your doctor's approval.||
2390|126|I|   This medication may interfere with certain lab tests (such as||
2390|127|I|allergy skin testing), possibly causing false test results. Make||
2390|128|I|sure lab personnel and all your doctors know you use this drug.||
2390|129|B|||
2390|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2390|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2390|132|O|poison control center right away. US residents can call||
2390|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2390|134|O|Symptoms of overdose may include: severe drowsiness.||
2390|135|B|||
2390|136|N|NOTES:  Do not share this medication with others.||
2390|137|B|||
2390|138|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2390|139|D|remember. If it is near the time of the next dose, skip the||
2390|140|D|missed dose. Take your next dose at the regular time. Do not||
2390|141|D|double the dose to catch up.||
2390|142|B|||
2390|143|R|STORAGE:  Store at room temperature away from light and moisture.||
2390|144|R|Keep the tablets in the original packaging until ready to use. Do||
2390|145|R|not store in the bathroom. Keep all medications away from||
2390|146|R|children and pets.||
2390|147|R|   Do not flush medications down the toilet or pour them into a||
2390|148|R|drain unless instructed to do so. Properly discard this product||
2390|149|R|when it is expired or no longer needed. Consult your pharmacist||
2390|150|R|or local waste disposal company.||
2390|151|B|||
2390|152|A|Information last revised May 2024.||
2390|153|A|Copyright(c) 2025 First Databank, Inc.||
2390|154|B|||
2391|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2391|002|Z|does NOT have all possible information about this product. This||
2391|003|Z|information does not assure that this product is safe, effective,||
2391|004|Z|or appropriate for you. This information is not individual||
2391|005|Z|medical advice and does not substitute for the advice of your||
2391|006|Z|health care professional. Always ask your health care||
2391|007|Z|professional for complete information about this product and your||
2391|008|Z|specific health needs.||
2391|009|B|||
2391|010|T|GLYCOPYRROLATE DISINTEGRATING TABLET - ORAL||
2391|011|F|(GLYE-koe-PIR-oh-late)||
2391|012|B|||
2391|013|C|COMMON BRAND NAME(S): Dartisla||
2391|014|B|||
2391|015|U|USES:  Glycopyrrolate is used with other drugs to treat a certain||
2391|016|U|type of stomach/intestinal ulcer (peptic ulcer). This medication||
2391|017|U|may help relieve stomach/abdominal pain. However, it has not been||
2391|018|U|shown to be effective in healing these ulcers, preventing them||
2391|019|U|from returning, or preventing other problems caused by ulcers.||
2391|020|U|Glycopyrrolate works by decreasing the amount of acid in the||
2391|021|U|stomach. It also slows the natural movements of the gut and||
2391|022|U|relaxes the muscles in the stomach/intestines. Glycopyrrolate||
2391|023|U|belongs to a class of drugs known as anticholinergics.||
2391|024|B|||
2391|025|H|HOW TO USE:  Take this medication by mouth on an empty stomach||
2391|026|H|(at least 1 hour before or 2 hours after food) as directed by||
2391|027|H|your doctor, usually 2 to 3 times a day. Do not remove the tablet||
2391|028|H|from the blister pack until just before taking. Dry your hands||
2391|029|H|before peeling back the foil on the blister pack to carefully||
2391|030|H|remove a tablet. Do not push the tablet through the foil. The||
2391|031|H|tablet should not be cut or broken before using. Place the tablet||
2391|032|H|on your tongue, allow it to dissolve, then swallow it with||
2391|033|H|saliva. Do not swallow the tablet with water.||
2391|034|H|   The dosage is based on your medical condition and response to||
2391|035|H|treatment. Do not increase your dose or use this drug more often||
2391|036|H|or for longer than prescribed. Your condition will not improve||
2391|037|H|any faster, and your risk of side effects will increase.||
2391|038|H|   Tell your doctor if your condition does not get better or if||
2391|039|H|it gets worse.||
2391|040|B|||
2391|041|S|SIDE EFFECTS:  Drowsiness, dizziness, blurred vision, dry||
2391|042|S|eyes/mouth, or constipation may occur. If any of these effects||
2391|043|S|last or get worse, tell your doctor or pharmacist promptly.||
2391|044|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
2391|045|S|chips, chew (sugarless) gum, drink water, or use a saliva||
2391|046|S|substitute. To relieve dry eyes, ask your pharmacist about||
2391|047|S|artificial tears or other eye lubricants.||
2391|048|S|   To prevent constipation, eat dietary fiber, drink enough||
2391|049|S|water, and exercise. You may also need to take a laxative. Ask||
2391|050|S|your pharmacist which type of laxative is right for you.||
2391|051|S|   Remember that this medication has been prescribed because your||
2391|052|S|doctor has judged that the benefit to you is greater than the||
2391|053|S|risk of side effects. Many people using this medication do not||
2391|054|S|have serious side effects.||
2391|055|S|   Tell your doctor right away if you have any serious side||
2391|056|S|effects, including: stomach/abdominal bloating or pain, diarrhea,||
2391|057|S|vomiting, decreased sweating, dry/hot/flushed skin,||
2391|058|S|fast/irregular heartbeat, mental/mood changes (such as confusion,||
2391|059|S|hallucinations, agitation, nervousness, unusual excitement),||
2391|060|S|difficulty urinating/inability to urinate.||
2391|061|S|   Get medical help right away if you have any very serious side||
2391|062|S|effects, including: eye pain/swelling/redness, vision changes||
2391|063|S|(such as seeing rainbows around lights at night).||
2391|064|S|   A very serious allergic reaction to this drug is rare.||
2391|065|S|However, get medical help right away if you notice any symptoms||
2391|066|S|of a serious allergic reaction, including: rash, itching/swelling||
2391|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2391|068|S|breathing.||
2391|069|S|   This is not a complete list of possible side effects. If you||
2391|070|S|notice other effects not listed above, contact your doctor or||
2391|071|S|pharmacist.||
2391|072|S|   In the US -||
2391|073|S|   Call your doctor for medical advice about side effects. You||
2391|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2391|075|S|www.fda.gov/medwatch.||
2391|076|S|   In Canada - Call your doctor for medical advice about side||
2391|077|S|effects. You may report side effects to Health Canada at||
2391|078|S|1-866-234-2345.||
2391|079|B|||
2391|080|P|PRECAUTIONS:  Before taking glycopyrrolate, tell your doctor or||
2391|081|P|pharmacist if you are allergic to it; or if you have any other||
2391|082|P|allergies. This product may contain inactive ingredients, which||
2391|083|P|can cause allergic reactions or other problems. Talk to your||
2391|084|P|pharmacist for more details.||
2391|085|P|   Before using this medication, tell your doctor or pharmacist||
2391|086|P|your medical history, especially of: glaucoma, problems with||
2391|087|P|urination (such as due to a blockage, enlarged prostate), other||
2391|088|P|stomach/intestinal problems (such as chronic constipation, slow||
2391|089|P|gut, intestinal blockage/infection, ulcerative colitis),||
2391|090|P|myasthenia gravis, kidney problems.||
2391|091|P|   This drug may make you dizzy or drowsy or cause blurred||
2391|092|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
2391|093|P|or drowsy. Do not drive, use machinery, or do anything that needs||
2391|094|P|alertness or clear vision until you can do it safely. Limit||
2391|095|P|alcoholic beverages. Talk to your doctor if you are using||
2391|096|P|marijuana (cannabis).||
2391|097|P|   This medication may make you sweat less, making you more||
2391|098|P|likely to get heat stroke. Avoid doing things that may cause you||
2391|099|P|to overheat, such as hard work or exercise in hot weather, or||
2391|100|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2391|101|P|and dress lightly. If you overheat, quickly look for a place to||
2391|102|P|cool down and rest. Get medical help right away if you have a||
2391|103|P|fever that does not go away, mental/mood changes, headache, or||
2391|104|P|dizziness.||
2391|105|P|   This medication may contain aspartame. If you have||
2391|106|P|phenylketonuria (PKU) or any other condition that requires you to||
2391|107|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
2391|108|P|doctor or pharmacist about using this medication safely.||
2391|109|P|   Before having surgery, tell your doctor or dentist about all||
2391|110|P|the products you use (including prescription drugs,||
2391|111|P|nonprescription drugs, and herbal products).||
2391|112|P|   Older adults may be more sensitive to the side effects of this||
2391|113|P|drug, especially drowsiness, confusion, unusual excitement,||
2391|114|P|constipation, and urination problems.||
2391|115|P|   During pregnancy, this medication should be used only when||
2391|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
2391|117|P|   It is unknown if this drug passes into breast milk. Consult||
2391|118|P|your doctor before breastfeeding.||
2391|119|B|||
2391|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2391|121|I|medications work or increase your risk for serious side effects.||
2391|122|I|This document does not contain all possible drug interactions.||
2391|123|I|Keep a list of all the products you use (including||
2391|124|I|prescription/nonprescription drugs and herbal products) and share||
2391|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
2391|126|I|the dosage of any medicines without your doctor's approval.||
2391|127|I|   Some products that may interact with this drug are: potassium||
2391|128|I|tablets/capsules, drugs that are affected by slowed gut movement||
2391|129|I|(such as pramlintide).||
2391|130|I|   Tell your doctor or pharmacist if you are using other products||
2391|131|I|that cause drowsiness such as opioid pain or cough relievers||
2391|132|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2391|133|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2391|134|I|zolpidem), muscle relaxants (such as carisoprodol,||
2391|135|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2391|136|I|diphenhydramine).||
2391|137|I|   Check the labels on all your medicines (such as allergy or||
2391|138|I|cough-and-cold products, diet aids) because they may contain||
2391|139|I|ingredients that cause drowsiness or a fast heartbeat. Ask your||
2391|140|I|pharmacist about using those products safely.||
2391|141|I|   This medication may interfere with certain lab tests (such as||
2391|142|I|gastric secretion tests), possibly causing false test results.||
2391|143|I|Make sure lab personnel and all your doctors know you use this||
2391|144|I|drug.||
2391|145|B|||
2391|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2391|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2391|148|O|poison control center right away. US residents can call||
2391|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2391|150|O|Symptoms of overdose may include: flushing, hot/dry skin, fever,||
2391|151|O|severe dizziness, mental/mood changes (such as confusion,||
2391|152|O|agitation), fast/irregular heartbeat, seizures.||
2391|153|B|||
2391|154|N|NOTES:  Do not share this medication with others.||
2391|155|N|   Lab and/or medical tests (such as stomach/intestinal exams)||
2391|156|N|should be done while you are taking this medication. Keep all||
2391|157|N|medical and lab appointments.||
2391|158|B|||
2391|159|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2391|160|D|remember. If it is near the time of the next dose, skip the||
2391|161|D|missed dose. Take your next dose at the regular time. Do not||
2391|162|D|double the dose to catch up.||
2391|163|B|||
2391|164|R|STORAGE:  Store at room temperature away from light and moisture.||
2391|165|R|Do not store in the bathroom. Keep all medications away from||
2391|166|R|children and pets.||
2391|167|R|   Do not flush medications down the toilet or pour them into a||
2391|168|R|drain unless instructed to do so. Properly discard this product||
2391|169|R|when it is expired or no longer needed. Consult your pharmacist||
2391|170|R|or local waste disposal company.||
2391|171|B|||
2391|172|A|Information last revised May 2024.||
2391|173|A|Copyright(c) 2025 First Databank, Inc.||
2391|174|B|||
2392|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2392|002|Z|does NOT have all possible information about this product. This||
2392|003|Z|information does not assure that this product is safe, effective,||
2392|004|Z|or appropriate for you. This information is not individual||
2392|005|Z|medical advice and does not substitute for the advice of your||
2392|006|Z|health care professional. Always ask your health care||
2392|007|Z|professional for complete information about this product and your||
2392|008|Z|specific health needs.||
2392|009|B|||
2392|010|T|LEVOKETOCONAZOLE - ORAL||
2392|011|F|(LEE-voe-KEE-toe-KON-a-zole)||
2392|012|B|||
2392|013|C|COMMON BRAND NAME(S): Recorlev||
2392|014|B|||
2392|015|W|WARNING:  Levoketoconazole has rarely caused very serious||
2392|016|W|(possibly fatal) liver problems. It should not be used by people||
2392|017|W|with severe liver disease, gallstones, or by people who had liver||
2392|018|W|problems caused by azole antifungal drugs (such as ketoconazole).||
2392|019|W|Get medical help right away if you develop symptoms of liver||
2392|020|W|problems, such as nausea/vomiting that doesn't stop, loss of||
2392|021|W|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2392|022|W|urine.||
2392|023|W|   Levoketoconazole may also cause a condition that affects the||
2392|024|W|heart rhythm (QT prolongation). QT prolongation can rarely cause||
2392|025|W|serious (rarely fatal) fast/irregular heartbeat and other||
2392|026|W|symptoms (such as severe dizziness, fainting) that need medical||
2392|027|W|attention right away. Levoketoconazole must not be used with||
2392|028|W|other medications that may also affect the heart rhythm (QT||
2392|029|W|prolongation) or be used by people with a history of certain||
2392|030|W|heart diseases (such as ventricular arrhythmias, long QT||
2392|031|W|syndrome). Tell your doctor and pharmacist about all the||
2392|032|W|medications and products you take before you start||
2392|033|W|levoketoconazole treatment. See also Precautions and Drug||
2392|034|W|Interactions sections.||
2392|035|W|   To reduce the risk of these very serious side effects, your||
2392|036|W|doctor should order tests (such as liver function, EKG) before||
2392|037|W|you start this medication and while you are taking it.||
2392|038|B|||
2392|039|U|USES:  This medication is used to treat high levels of a certain||
2392|040|U|hormone (cortisol) in people with Cushing's syndrome.||
2392|041|U|Levoketoconazole works by decreasing the amount of cortisol made||
2392|042|U|by the body.||
2392|043|B|||
2392|044|H|HOW TO USE:  Read the Medication Guide provided by your||
2392|045|H|pharmacist before you start taking levoketoconazole and each time||
2392|046|H|you get a refill. If you have any questions, ask your doctor or||
2392|047|H|pharmacist.||
2392|048|H|   Take this medication by mouth with or without food as directed||
2392|049|H|by your doctor, usually twice a day. The dosage is based on your||
2392|050|H|medical condition, lab tests, and response to treatment.||
2392|051|H|   If you are taking an antacid, take levoketoconazole at least 2||
2392|052|H|hours before taking the antacid, or levoketoconazole may not be||
2392|053|H|absorbed into the body. See also Drug Interactions section for||
2392|054|H|more information.||
2392|055|H|   Use this medication regularly to get the most benefit from it.||
2392|056|H|To help you remember, take it at the same times each day.||
2392|057|H|   Tell your doctor if your condition does not get better or if||
2392|058|H|it gets worse.||
2392|059|B|||
2392|060|S|SIDE EFFECTS:  See also Warning section.||
2392|061|S|   Nausea, vomiting, upset stomach, or headache may occur. If any||
2392|062|S|of these effects last or get worse, tell your doctor or||
2392|063|S|pharmacist promptly.||
2392|064|S|   Remember that this medication has been prescribed because your||
2392|065|S|doctor has judged that the benefit to you is greater than the||
2392|066|S|risk of side effects. Many people using this medication do not||
2392|067|S|have serious side effects.||
2392|068|S|   Tell your doctor right away if you have any serious side||
2392|069|S|effects, including: easy bleeding/bruising.||
2392|070|S|   Although this is unlikely, levoketoconazole may lower your||
2392|071|S|cortisol levels too much and cause an adrenal gland problem||
2392|072|S|(adrenal insufficiency). It may also decrease testosterone levels||
2392|073|S|and sperm production. The adrenal gland problem may make it more||
2392|074|S|difficult for your body to respond to physical stress. Before||
2392|075|S|having surgery or emergency treatment, or if you get a serious||
2392|076|S|illness/injury, tell your doctor or dentist that you are using||
2392|077|S|this medication. Tell your doctor right away if you have any||
2392|078|S|serious side effects, including: unusual tiredness, weakness,||
2392|079|S|dizziness upon standing, diarrhea, weight loss, menstrual period||
2392|080|S|changes, mental/mood changes (such as depression), decreased||
2392|081|S|sexual interest or ability, enlarged/tender breasts in men.||
2392|082|S|   Get medical help right away if you have any very serious side||
2392|083|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2392|084|S|fainting.||
2392|085|S|   A very serious allergic reaction to this drug is rare.||
2392|086|S|However, get medical help right away if you notice any symptoms||
2392|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2392|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2392|089|S|breathing.||
2392|090|S|   This is not a complete list of possible side effects. If you||
2392|091|S|notice other effects not listed above, contact your doctor or||
2392|092|S|pharmacist.||
2392|093|S|   In the US -||
2392|094|S|   Call your doctor for medical advice about side effects. You||
2392|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2392|096|S|www.fda.gov/medwatch.||
2392|097|S|   In Canada - Call your doctor for medical advice about side||
2392|098|S|effects. You may report side effects to Health Canada at||
2392|099|S|1-866-234-2345.||
2392|100|B|||
2392|101|P|PRECAUTIONS:  See also Warning and Side Effects sections.||
2392|102|P|   Before taking levoketoconazole, tell your doctor or pharmacist||
2392|103|P|if you are allergic to it; or to azole antifungal drugs (such as||
2392|104|P|ketoconazole, itraconazole); or if you have any other allergies.||
2392|105|P|This product may contain inactive ingredients, which can cause||
2392|106|P|allergic reactions or other problems. Talk to your pharmacist for||
2392|107|P|more details.||
2392|108|P|   Before using this medication, tell your doctor or pharmacist||
2392|109|P|your medical history, especially of: liver problems, alcohol use,||
2392|110|P|low testosterone levels, little or no stomach acid production||
2392|111|P|(achlorhydria).||
2392|112|P|   Levoketoconazole may cause a condition that affects the heart||
2392|113|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2392|114|P|serious (rarely fatal) fast/irregular heartbeat and other||
2392|115|P|symptoms (such as severe dizziness, fainting) that need medical||
2392|116|P|attention right away.||
2392|117|P|   The risk of QT prolongation may be increased if you have||
2392|118|P|certain medical conditions or are taking other drugs that may||
2392|119|P|cause QT prolongation. Before using levoketoconazole, tell your||
2392|120|P|doctor or pharmacist of all the drugs you take and if you have||
2392|121|P|any of the following conditions: certain heart problems (heart||
2392|122|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2392|123|P|history of certain heart problems (QT prolongation in the EKG,||
2392|124|P|sudden cardiac death).||
2392|125|P|   Low levels of potassium or magnesium in the blood may also||
2392|126|P|increase your risk of QT prolongation. This risk may increase if||
2392|127|P|you use certain drugs (such as diuretics/"water pills") or if you||
2392|128|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2392|129|P|Talk to your doctor about using levoketoconazole safely.||
2392|130|P|   Before having surgery, tell your doctor or dentist about all||
2392|131|P|the products you use (including prescription drugs,||
2392|132|P|nonprescription drugs, and herbal products).||
2392|133|P|   Limit drinking alcoholic beverages while taking this||
2392|134|P|medication because alcohol increases the risk of serious liver||
2392|135|P|problems. Alcoholic beverages may also cause a rare reaction with||
2392|136|P|levoketoconazole that may result in flushing, headache, and||
2392|137|P|nausea.||
2392|138|P|   Older adults may be more sensitive to the side effects of this||
2392|139|P|drug, especially QT prolongation (see above).||
2392|140|P|   During pregnancy, this medication should be used only when||
2392|141|P|clearly needed. Discuss the risks and benefits with your doctor.||
2392|142|P|   This medication passes into breast milk. Because of the||
2392|143|P|possible risk to the infant, breastfeeding is not recommended||
2392|144|P|while using this medication and for one day after the last dose.||
2392|145|P|Consult your doctor before breastfeeding.||
2392|146|B|||
2392|147|I|DRUG INTERACTIONS:  See also How to Use section.||
2392|148|I|   Drug interactions may change how your medications work or||
2392|149|I|increase your risk for serious side effects. This document does||
2392|150|I|not contain all possible drug interactions. Keep a list of all||
2392|151|I|the products you use (including prescription/nonprescription||
2392|152|I|drugs and herbal products) and share it with your doctor and||
2392|153|I|pharmacist. Do not start, stop, or change the dosage of any||
2392|154|I|medicines without your doctor's approval.||
2392|155|I|   Levoketoconazole interacts with many prescription and||
2392|156|I|nonprescription drugs. While you are taking levoketoconazole, it||
2392|157|I|is very important to tell your doctor or pharmacist of any||
2392|158|I|changes in medications that you are taking.||
2392|159|I|   Some products that may interact with this drug are: other||
2392|160|I|drugs that can cause liver problems (such as acetaminophen).||
2392|161|I|   Other medications can affect the removal of levoketoconazole||
2392|162|I|from your body, which may affect how levoketoconazole works.||
2392|163|I|Examples include encorafenib, HIV protease inhibitors (such as||
2392|164|I|fosamprenavir), isoniazid, nevirapine, rifamycins (such as||
2392|165|I|rifabutin, rifampin), ritonavir, St. John's wort, drugs used to||
2392|166|I|treat seizures (such as carbamazepine, phenytoin), among others.||
2392|167|I|   This medication can slow down the removal of many other||
2392|168|I|medications from your body, which may affect how they work.||
2392|169|I|Examples of affected drugs include some benzodiazepines (such as||
2392|170|I|alprazolam, midazolam, triazolam), domperidone, eletriptan,||
2392|171|I|eplerenone, ergot drugs (such as ergotamine), nisoldipine, drugs||
2392|172|I|used to treat erectile dysfunction-ED or pulmonary hypertension||
2392|173|I|(such as sildenafil, tadalafil), some statin drugs (such as||
2392|174|I|lovastatin, simvastatin), among others.||
2392|175|I|   Many drugs besides levoketoconazole may affect the heart||
2392|176|I|rhythm (QT prolongation), including amiodarone, bosutinib,||
2392|177|I|disopyramide, dofetilide, dronedarone, methadone, pacritinib,||
2392|178|I|pimozide, quinidine, ranolazine, among others.||
2392|179|I|   Levoketoconazole requires acid in the stomach to be well||
2392|180|I|absorbed. If you are taking drugs that decrease the amount of||
2392|181|I|stomach acid (including sucralfate, H2 blockers such as||
2392|182|I|famotidine/ranitidine, proton pump inhibitors such as||
2392|183|I|lansoprazole/omeprazole), ask your doctor or pharmacist for||
2392|184|I|advice on how to reduce or avoid this interaction. Antacids may||
2392|185|I|be taken at least 2 hours after taking levoketoconazole.||
2392|186|I|   Levoketoconazole is very similar to ketoconazole. Do not use||
2392|187|I|medications containing ketoconazole while using levoketoconazole.||
2392|188|B|||
2392|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2392|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2392|191|O|poison control center right away. US residents can call||
2392|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2392|193|B|||
2392|194|N|NOTES:  Do not share this medication with others.||
2392|195|N|   Lab and/or medical tests (such as EKG, urine/blood cortisol||
2392|196|N|levels, liver function, blood potassium/magnesium levels) should||
2392|197|N|be done before you start taking this medication and while you are||
2392|198|N|taking it. Keep all medical and lab appointments. Consult your||
2392|199|N|doctor for more details.||
2392|200|B|||
2392|201|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2392|202|D|next dose at the regular time. Do not double the dose to catch||
2392|203|D|up.||
2392|204|B|||
2392|205|R|STORAGE:  Store at room temperature away from light and moisture.||
2392|206|R|Do not store in the bathroom. Keep all medications away from||
2392|207|R|children and pets.||
2392|208|R|   Do not flush medications down the toilet or pour them into a||
2392|209|R|drain unless instructed to do so. Properly discard this product||
2392|210|R|when it is expired or no longer needed. Consult your pharmacist||
2392|211|R|or local waste disposal company.||
2392|212|B|||
2392|213|A|Information last revised July 2024.||
2392|214|A|Copyright(c) 2025 First Databank, Inc.||
2392|215|B|||
2393|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2393|002|Z|does NOT have all possible information about this product. This||
2393|003|Z|information does not assure that this product is safe, effective,||
2393|004|Z|or appropriate for you. This information is not individual||
2393|005|Z|medical advice and does not substitute for the advice of your||
2393|006|Z|health care professional. Always ask your health care||
2393|007|Z|professional for complete information about this product and your||
2393|008|Z|specific health needs.||
2393|009|B|||
2393|010|T|TEZEPELUMAB - INJECTION||
2393|011|F|(TEZ-e-PEL-ue-mab)||
2393|012|B|||
2393|013|C|COMMON BRAND NAME(S): Tezspire||
2393|014|B|||
2393|015|U|USES:  This medication is used with other medications to control||
2393|016|U|and prevent symptoms of severe asthma (such as wheezing and||
2393|017|U|shortness of breath). Controlling symptoms of asthma helps you||
2393|018|U|maintain your normal activities and decreases time lost from work||
2393|019|U|or school. Tezepelumab may also be used to reduce symptoms caused||
2393|020|U|by nasal polyps and the long-term swelling of the sinuses and||
2393|021|U|nasal passage (chronic rhinosinusitis with nasal polyps).||
2393|022|U|Tezepelumab belongs to a class of medications known as monoclonal||
2393|023|U|antibodies. It helps reduce swelling (inflammation) in the||
2393|024|U|airways of the lungs to make breathing easier. It may also help||
2393|025|U|reduce the size of nasal polyps and lessen symptoms such as||
2393|026|U|stuffy nose and loss of smell.||
2393|027|U|   This medication must be used regularly to be effective. It||
2393|028|U|does not work right away and should not be used to relieve sudden||
2393|029|U|asthma attacks or breathing problems. If an asthma attack occurs,||
2393|030|U|use your quick-relief inhaler as prescribed.||
2393|031|B|||
2393|032|H|HOW TO USE:  Read the Patient Information Leaflet and||
2393|033|H|Instructions for Use if available from your pharmacist before you||
2393|034|H|start using tezepelumab and each time you get a refill. If you||
2393|035|H|have any questions, ask your doctor or pharmacist.||
2393|036|H|   Inject this medication under the skin as directed by your||
2393|037|H|doctor, usually once every 4 weeks. The injection is given in the||
2393|038|H|upper arm, thigh, or abdomen.||
2393|039|H|   If you are using this medication at home, learn all||
2393|040|H|preparation and usage instructions from your health care||
2393|041|H|professional and the product package. Take the medication out of||
2393|042|H|the refrigerator at least 60 minutes before you inject it to||
2393|043|H|allow it to reach room temperature. Do not warm up this||
2393|044|H|medication any other way (for example, do not heat it in the||
2393|045|H|microwave, place it in hot water, or leave it in direct||
2393|046|H|sunlight). Do not shake the medication. Before using, check this||
2393|047|H|product for particles or discoloration. If either is present, do||
2393|048|H|not use the liquid. Before injecting each dose, clean the skin||
2393|049|H|you are going to inject into (the injection site) with rubbing||
2393|050|H|alcohol. Change the injection site each time to lessen injury||
2393|051|H|under the skin. Do not inject into skin that is tender, bruised,||
2393|052|H|red, hard, or damaged. To lessen bruising, do not rub the||
2393|053|H|injection site after a shot. Learn how to store and discard||
2393|054|H|medical supplies safely.||
2393|055|H|   If you are regularly using a corticosteroid medication, you||
2393|056|H|should not stop using it unless directed by your doctor. Some||
2393|057|H|conditions (such as asthma, allergies) may become worse when the||
2393|058|H|drug is suddenly stopped. If you suddenly stop using the||
2393|059|H|corticosteroid medication, you may also have withdrawal symptoms||
2393|060|H|(such as weakness, weight loss, nausea, muscle pain, headache,||
2393|061|H|tiredness, dizziness). To help prevent withdrawal, your doctor||
2393|062|H|may slowly lower the dose of your corticosteroid medication after||
2393|063|H|you begin using tezepelumab. Tell your doctor or pharmacist right||
2393|064|H|away if you have withdrawal.||
2393|065|H|   Use this medication regularly to get the most benefit from it.||
2393|066|H|To help you remember, mark your calendar with a reminder.||
2393|067|H|   Tell your doctor if your condition does not get better or if||
2393|068|H|it gets worse.||
2393|069|B|||
2393|070|S|SIDE EFFECTS:  Pain, redness, or swelling at the injection site||
2393|071|S|may occur. If any of these effects last or get worse, tell your||
2393|072|S|doctor or pharmacist promptly.||
2393|073|S|   Remember that this medication has been prescribed because your||
2393|074|S|doctor has judged that the benefit to you is greater than the||
2393|075|S|risk of side effects. Many people using this medication do not||
2393|076|S|have serious side effects.||
2393|077|S|   A very serious allergic reaction to this drug is rare.||
2393|078|S|However, get medical help right away if you notice any symptoms||
2393|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2393|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2393|081|S|breathing.||
2393|082|S|   This is not a complete list of possible side effects. If you||
2393|083|S|notice other effects not listed above, contact your doctor or||
2393|084|S|pharmacist.||
2393|085|S|   In the US -||
2393|086|S|   Call your doctor for medical advice about side effects. You||
2393|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2393|088|S|www.fda.gov/medwatch.||
2393|089|S|   In Canada - Call your doctor for medical advice about side||
2393|090|S|effects. You may report side effects to Health Canada at||
2393|091|S|1-866-234-2345.||
2393|092|B|||
2393|093|P|PRECAUTIONS:  Before using tezepelumab, tell your doctor or||
2393|094|P|pharmacist if you are allergic to it; or if you have any other||
2393|095|P|allergies. This product may contain inactive ingredients, which||
2393|096|P|can cause allergic reactions or other problems. Talk to your||
2393|097|P|pharmacist for more details.||
2393|098|P|   Before using this medication, tell your doctor or pharmacist||
2393|099|P|your medical history, especially of: infection due to a parasite||
2393|100|P|(helminth).||
2393|101|P|   Tell your health care professional that you are using||
2393|102|P|tezepelumab before having any immunizations/vaccinations. Avoid||
2393|103|P|contact with people who have recently received live vaccines||
2393|104|P|(such as flu vaccine inhaled through the nose).||
2393|105|P|   Before having surgery, tell your doctor or dentist about all||
2393|106|P|the products you use (including prescription drugs,||
2393|107|P|nonprescription drugs, and herbal products).||
2393|108|P|   During pregnancy, this medication should be used only when||
2393|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
2393|110|P|   It is unknown if this medication passes into breast milk.||
2393|111|P|Consult your doctor before breastfeeding.||
2393|112|B|||
2393|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2393|114|I|medications work or increase your risk for serious side effects.||
2393|115|I|This document does not contain all possible drug interactions.||
2393|116|I|Keep a list of all the products you use (including||
2393|117|I|prescription/nonprescription drugs and herbal products) and share||
2393|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
2393|119|I|the dosage of any medicines without your doctor's approval.||
2393|120|B|||
2393|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2393|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2393|123|O|poison control center right away. US residents can call||
2393|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2393|125|B|||
2393|126|N|NOTES:  Do not share this medication with others.||
2393|127|N|   Keep all medical and lab appointments.||
2393|128|B|||
2393|129|D|MISSED DOSE:  It is important to get each dose of this medication||
2393|130|D|as scheduled. If your dose is given by a health care professional||
2393|131|D|and you miss a dose, ask your doctor right away for a new dosing||
2393|132|D|schedule. If you are using this medication at home and miss a||
2393|133|D|dose, use it as soon as you remember. Use your next dose on the||
2393|134|D|regular day. Do not double the dose to catch up.||
2393|135|B|||
2393|136|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2393|137|R|medication in the original carton to protect from light. This||
2393|138|R|medication may also be stored at room temperature if needed. If||
2393|139|R|the medication is stored at room temperature, do not put it back||
2393|140|R|in the refrigerator and discard after 30 days. Keep all||
2393|141|R|medications away from children and pets.||
2393|142|R|   Do not flush medications down the toilet or pour them into a||
2393|143|R|drain unless instructed to do so. Properly discard this product||
2393|144|R|when it is expired or no longer needed. Consult your pharmacist||
2393|145|R|or local waste disposal company.||
2393|146|B|||
2393|147|A|Information last revised October 2025.||
2393|148|A|Copyright(c) 2025 First Databank, Inc.||
2393|149|B|||
2394|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2394|002|Z|does NOT have all possible information about this product. This||
2394|003|Z|information does not assure that this product is safe, effective,||
2394|004|Z|or appropriate for you. This information is not individual||
2394|005|Z|medical advice and does not substitute for the advice of your||
2394|006|Z|health care professional. Always ask your health care||
2394|007|Z|professional for complete information about this product and your||
2394|008|Z|specific health needs.||
2394|009|B|||
2394|010|T|BUDESONIDE 4 MG CAPSULE - ORAL||
2394|011|F|(bue-DES-oh-nide)||
2394|012|B|||
2394|013|C|COMMON BRAND NAME(S): Tarpeyo||
2394|014|B|||
2394|015|U|USES:  This medication is used to treat a certain kidney problem||
2394|016|U|(primary immunoglobulin A nephropathy). Budesonide helps to||
2394|017|U|reduce the loss of kidney function. Budesonide is an||
2394|018|U|anti-inflammatory drug (corticosteroid hormone). It works by||
2394|019|U|decreasing the body's natural defense response (immune response).||
2394|020|B|||
2394|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2394|022|H|from your pharmacist before you start taking budesonide and each||
2394|023|H|time you get a refill. If you have any questions, ask your doctor||
2394|024|H|or pharmacist.||
2394|025|H|   Take this medication by mouth as directed by your doctor,||
2394|026|H|usually once daily in the morning at least 1 hour before a meal.||
2394|027|H|Swallow this medication whole with a full glass of water (8||
2394|028|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
2394|029|H|Do not crush or chew the capsules. Doing so can release all of||
2394|030|H|the drug at once, increasing the risk of side effects.||
2394|031|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2394|032|H|using this medication unless your doctor or pharmacist says you||
2394|033|H|may do so safely. Grapefruit can increase the chance of side||
2394|034|H|effects with this medicine. Ask your doctor or pharmacist for||
2394|035|H|more details.||
2394|036|H|   If you are regularly taking a different corticosteroid by||
2394|037|H|mouth (such as prednisone), you should not stop taking it unless||
2394|038|H|directed by your doctor. Some conditions (such as asthma,||
2394|039|H|allergies) may become worse when the drug is suddenly stopped. If||
2394|040|H|you suddenly stop taking the drug, you may also have withdrawal||
2394|041|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
2394|042|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
2394|043|H|doctor may slowly lower the dose of your old medication after you||
2394|044|H|begin taking budesonide. Tell your doctor or pharmacist right||
2394|045|H|away if you have withdrawal. See also Precautions section.||
2394|046|H|   Use this medication regularly to get the most benefit from it.||
2394|047|H|To help you remember, take it at the same time each day. Do not||
2394|048|H|increase your dose or use this drug more often or for longer than||
2394|049|H|prescribed. Your condition will not improve any faster, and your||
2394|050|H|risk of side effects will increase.||
2394|051|H|   Do not stop taking this medication without consulting your||
2394|052|H|doctor. Some conditions may become worse when this drug is||
2394|053|H|suddenly stopped. Your dose may need to be gradually decreased.||
2394|054|H|   Tell your doctor if your condition does not get better or if||
2394|055|H|it gets worse.||
2394|056|B|||
2394|057|S|SIDE EFFECTS:  This medication usually has fewer side effects||
2394|058|S|than other corticosteroids because budesonide works in the gut||
2394|059|S|and only small amounts are absorbed into the body. Acne, muscle||
2394|060|S|spasms, or swelling hands/ankles/feet may occur. If any of these||
2394|061|S|effects last or get worse, tell your doctor or pharmacist||
2394|062|S|promptly.||
2394|063|S|   Remember that this medication has been prescribed because your||
2394|064|S|doctor has judged that the benefit to you is greater than the||
2394|065|S|risk of side effects. Many people using this medication do not||
2394|066|S|have serious side effects.||
2394|067|S|   Because this drug works by weakening the immune system, it may||
2394|068|S|lower your ability to fight infections. This may make you more||
2394|069|S|likely to get a serious (rarely fatal) infection or make any||
2394|070|S|infection you have worse. Tell your doctor right away if you have||
2394|071|S|any signs of infection (such as sore throat that doesn't go away,||
2394|072|S|fever, chills). This medication may sometimes cause oral thrush||
2394|073|S|or a new yeast infection. Contact your doctor if you notice white||
2394|074|S|patches in your mouth, a change in vaginal discharge, or other||
2394|075|S|new symptoms.||
2394|076|S|   Tell your doctor right away if you have any serious side||
2394|077|S|effects, including: easy bruising/bleeding, puffy face, unusual||
2394|078|S|weight gain, menstrual period changes, mental/mood changes (such||
2394|079|S|as depression, mood swings, agitation), weakness, bone pain,||
2394|080|S|thinning skin, slow wound healing, increased thirst/urination,||
2394|081|S|vision problems, red/purple spots on the skin.||
2394|082|S|   A very serious allergic reaction to this drug is rare.||
2394|083|S|However, get medical help right away if you notice any symptoms||
2394|084|S|of a serious allergic reaction, including: rash, itching/swelling||
2394|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2394|086|S|breathing.||
2394|087|S|   This is not a complete list of possible side effects. If you||
2394|088|S|notice other effects not listed above, contact your doctor or||
2394|089|S|pharmacist.||
2394|090|S|   In the US -||
2394|091|S|   Call your doctor for medical advice about side effects. You||
2394|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2394|093|S|www.fda.gov/medwatch.||
2394|094|S|   In Canada - Call your doctor for medical advice about side||
2394|095|S|effects. You may report side effects to Health Canada at||
2394|096|S|1-866-234-2345.||
2394|097|B|||
2394|098|P|PRECAUTIONS:  Before taking budesonide, tell your doctor or||
2394|099|P|pharmacist if you are allergic to it; or if you have any other||
2394|100|P|allergies. This product may contain inactive ingredients, which||
2394|101|P|can cause allergic reactions or other problems. Talk to your||
2394|102|P|pharmacist for more details.||
2394|103|P|   Before using this medication, tell your doctor or pharmacist||
2394|104|P|your medical history, especially of: eye problems (such as||
2394|105|P|cataracts, glaucoma), high blood pressure, liver problems (such||
2394|106|P|as hepatitis B), diabetes, stomach/intestinal problems (such as||
2394|107|P|diverticulitis, ulcer), bone loss (osteoporosis), current/past||
2394|108|P|infections (such as tuberculosis, herpes), bleeding problems,||
2394|109|P|mental/mood problems (such as psychosis, anxiety, depression), a||
2394|110|P|certain adrenal gland tumor (pheochromocytoma).||
2394|111|P|   Using corticosteroid medications for a long time can make it||
2394|112|P|more difficult for your body to respond to physical stress.||
2394|113|P|Before having surgery or emergency treatment, or if you get a||
2394|114|P|serious illness/injury, tell your doctor or dentist that you are||
2394|115|P|using this medication or have used this medication within the||
2394|116|P|past 12 months. Tell your doctor right away if you develop||
2394|117|P|unusual/extreme tiredness or weight loss. If you will be using||
2394|118|P|this medication for a long time, carry a warning card or medical||
2394|119|P|ID bracelet that identifies your use of this medication.||
2394|120|P|   Before having surgery, tell your doctor or dentist about all||
2394|121|P|the products you use (including prescription drugs,||
2394|122|P|nonprescription drugs, and herbal products).||
2394|123|P|   Daily use of alcohol while using this medicine may increase||
2394|124|P|your risk for stomach bleeding. Limit alcoholic beverages.||
2394|125|P|Consult your doctor or pharmacist for more information.||
2394|126|P|   This medication can make you more likely to get infections or||
2394|127|P|may make current infections worse. Stay away from anyone who has||
2394|128|P|an infection that may easily spread (such as chickenpox,||
2394|129|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2394|130|P|exposed to an infection or for more details.||
2394|131|P|   Tell your health care professional that you are using||
2394|132|P|budesonide before having any immunizations/vaccinations. Avoid||
2394|133|P|contact with people who have recently received live vaccines||
2394|134|P|(such as flu vaccine inhaled through the nose).||
2394|135|P|   Older adults may be more sensitive to the side effects of this||
2394|136|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
2394|137|P|mental/mood changes (such as confusion).||
2394|138|P|   This medication may slow down a child's growth if used for a||
2394|139|P|long time. Consult the doctor or pharmacist for more details. See||
2394|140|P|the doctor regularly so your child's height and growth can be||
2394|141|P|checked.||
2394|142|P|   During pregnancy, this medication should be used only when||
2394|143|P|clearly needed. Discuss the risks and benefits with your doctor.||
2394|144|P|Babies born to mothers who have used corticosteroids for a long||
2394|145|P|time may develop hormone problems. Tell your doctor right away if||
2394|146|P|you notice symptoms such as nausea/vomiting that doesn't stop,||
2394|147|P|severe diarrhea, or weakness in your newborn.||
2394|148|P|   This medication passes into breast milk. Consult your doctor||
2394|149|P|before breastfeeding.||
2394|150|B|||
2394|151|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2394|152|I|medications work or increase your risk for serious side effects.||
2394|153|I|This document does not contain all possible drug interactions.||
2394|154|I|Keep a list of all the products you use (including||
2394|155|I|prescription/nonprescription drugs and herbal products) and share||
2394|156|I|it with your doctor and pharmacist. Do not start, stop, or change||
2394|157|I|the dosage of any medicines without your doctor's approval.||
2394|158|I|   Some products that may interact with this drug are:||
2394|159|I|aldesleukin, desmopressin, mifepristone, drugs that can cause||
2394|160|I|bleeding/bruising (including antiplatelet drugs such as||
2394|161|I|clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs||
2394|162|I|such as aspirin/celecoxib/ibuprofen).||
2394|163|I|   If your doctor has told you to take low-dose aspirin to||
2394|164|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
2394|165|I|you should keep taking the aspirin unless your doctor tells you||
2394|166|I|not to. Ask your doctor or pharmacist for more details.||
2394|167|I|   This product may interfere with certain lab tests (such as||
2394|168|I|skin tests), possibly causing false test results. Make sure lab||
2394|169|I|personnel and all your doctors know you use this drug.||
2394|170|B|||
2394|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2394|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2394|173|O|poison control center right away. US residents can call||
2394|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2394|175|B|||
2394|176|N|NOTES:  Do not share this medication with others.||
2394|177|N|   If this medication is used for a long time, lab and/or medical||
2394|178|N|tests (such as blood count, bone density, eye exams,||
2394|179|N|height/weight measurements) may be done while you are taking it.||
2394|180|N|Keep all medical and lab appointments. Consult your doctor for||
2394|181|N|more details.||
2394|182|N|   This medication may cause bone loss (osteoporosis) when used||
2394|183|N|for a long time. Lifestyle changes that may help reduce the risk||
2394|184|N|of bone problems include doing weight-bearing exercise, stopping||
2394|185|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2394|186|N|D. Talk to your doctor for more details.||
2394|187|B|||
2394|188|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2394|189|D|remember. If it is near the time of the next dose, skip the||
2394|190|D|missed dose. Take your next dose at the regular time. Do not||
2394|191|D|double the dose to catch up.||
2394|192|B|||
2394|193|R|STORAGE:  Store at room temperature away from light and moisture.||
2394|194|R|Do not store in the bathroom. Keep all medications away from||
2394|195|R|children and pets.||
2394|196|R|   Do not flush medications down the toilet or pour them into a||
2394|197|R|drain unless instructed to do so. Properly discard this product||
2394|198|R|when it is expired or no longer needed. Consult your pharmacist||
2394|199|R|or local waste disposal company.||
2394|200|B|||
2394|201|M|MEDICAL ALERT:  Your condition can cause complications in a||
2394|202|M|medical emergency. For information about enrolling in MedicAlert,||
2394|203|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2394|204|B|||
2394|205|A|Information last revised September 2025.||
2394|206|A|Copyright(c) 2025 First Databank, Inc.||
2394|207|B|||
2395|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2395|002|Z|does NOT have all possible information about this product. This||
2395|003|Z|information does not assure that this product is safe, effective,||
2395|004|Z|or appropriate for you. This information is not individual||
2395|005|Z|medical advice and does not substitute for the advice of your||
2395|006|Z|health care professional. Always ask your health care||
2395|007|Z|professional for complete information about this product and your||
2395|008|Z|specific health needs.||
2395|009|B|||
2395|010|T|VOXELOTOR TABLET - FOR ORAL SUSPENSION||
2395|011|F|(vox-EL-oh-tor)||
2395|012|B|||
2395|013|C|COMMON BRAND NAME(S): Oxbryta||
2395|014|B|||
2395|015|U|USES:  This medication is used to treat sickle cell disease.||
2395|016|U|People with sickle cell disease have a certain abnormal protein||
2395|017|U|(hemoglobin S) in their red blood cells that makes the cells||
2395|018|U|stiff and irregularly shaped (sickle- or crescent moon-shaped).||
2395|019|U|Voxelotor works by decreasing hemoglobin S. This effect may||
2395|020|U|decrease symptoms such as tiredness, shortness of breath, and||
2395|021|U|attacks of pain (sickle cell crisis).||
2395|022|U|   This drug has been withdrawn from the US market due to||
2395|023|U|problems with safety.||
2395|024|B|||
2395|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
2395|026|H|Instructions for Use available from your pharmacist before you||
2395|027|H|start taking voxelotor and each time you get a refill. If you||
2395|028|H|have any questions, ask your doctor or pharmacist.||
2395|029|H|   Take this medication by mouth with or without food as directed||
2395|030|H|by your doctor, usually once daily. The dosage is based on your||
2395|031|H|weight, medical condition, response to treatment, and other||
2395|032|H|medications you may be taking. Be sure to tell your doctor and||
2395|033|H|pharmacist about all the products you use (including prescription||
2395|034|H|drugs, nonprescription drugs, and herbal products).||
2395|035|H|   This medication comes in 2 different tablet forms which are||
2395|036|H|not taken the same way. Check that you receive the correct form||
2395|037|H|each time you receive your medication to avoid taking the wrong||
2395|038|H|form of this medication.||
2395|039|H|   Do not cut, crush, or chew this medicine. Do not swallow it||
2395|040|H|whole.||
2395|041|H|   This form of voxelotor must be mixed in liquid before taking.||
2395|042|H|Use room temperature clear liquid (such as drinking water, clear||
2395|043|H|soda, apple juice, clear electrolyte drinks, clear flavored||
2395|044|H|drinks, or clear sports drinks) to mix with your dose. Place the||
2395|045|H|clear liquid and tablet(s) in a cup and swirl the cup until the||
2395|046|H|tablet(s) break into small pieces. The tablet(s) will not||
2395|047|H|completely dissolve. If you spill any medicine, clean up the||
2395|048|H|spill, throw out the rest of the medicine, and make a new dose.||
2395|049|H|After preparing the medicine, wait 1 to 5 minutes. Swirl the cup||
2395|050|H|again, and drink the medicine. Add 1 to 2 teaspoons of liquid to||
2395|051|H|the cup, swirl to mix, and drink all of the mixture to make sure||
2395|052|H|you are getting all of the drug. Repeat until there is no more||
2395|053|H|medicine left in the cup.||
2395|054|H|   Use this medication regularly to get the most benefit from it.||
2395|055|H|To help you remember, take it at the same time each day.||
2395|056|H|   Tell your doctor if your symptoms do not get better or if they||
2395|057|H|get worse.||
2395|058|B|||
2395|059|S|SIDE EFFECTS:  Headache, diarrhea, nausea, stomach/abdominal||
2395|060|S|pain, or fever may occur. If any of these effects last or get||
2395|061|S|worse, tell your doctor or pharmacist promptly.||
2395|062|S|   Remember that this medication has been prescribed because your||
2395|063|S|doctor has judged that the benefit to you is greater than the||
2395|064|S|risk of side effects. Many people using this medication do not||
2395|065|S|have serious side effects.||
2395|066|S|   A very serious allergic reaction to this drug is rare.||
2395|067|S|However, get medical help right away if you notice any symptoms||
2395|068|S|of a serious allergic reaction, including: fever, swollen lymph||
2395|069|S|nodes, rash, itching/swelling (especially of the||
2395|070|S|face/tongue/throat), severe dizziness, trouble breathing.||
2395|071|S|   This is not a complete list of possible side effects. If you||
2395|072|S|notice other effects not listed above, contact your doctor or||
2395|073|S|pharmacist.||
2395|074|S|   In the US -||
2395|075|S|   Call your doctor for medical advice about side effects. You||
2395|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2395|077|S|www.fda.gov/medwatch.||
2395|078|S|   In Canada - Call your doctor for medical advice about side||
2395|079|S|effects. You may report side effects to Health Canada at||
2395|080|S|1-866-234-2345.||
2395|081|B|||
2395|082|P|PRECAUTIONS:  Before taking voxelotor, tell your doctor or||
2395|083|P|pharmacist if you are allergic to it; or if you have any other||
2395|084|P|allergies. This product may contain inactive ingredients, which||
2395|085|P|can cause allergic reactions or other problems. Talk to your||
2395|086|P|pharmacist for more details.||
2395|087|P|   Before using this medication, tell your doctor or pharmacist||
2395|088|P|your medical history, especially of: liver problems.||
2395|089|P|   Before having surgery, tell your doctor or dentist about all||
2395|090|P|the products you use (including prescription drugs,||
2395|091|P|nonprescription drugs, and herbal products).||
2395|092|P|   During pregnancy, this medication should be used only when||
2395|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
2395|094|P|   It is unknown if this medication passes into breast milk.||
2395|095|P|Because of the possible risk to the infant, breastfeeding is not||
2395|096|P|recommended while using this medication and for at least 2 weeks||
2395|097|P|after the last dose. Consult your doctor before breastfeeding.||
2395|098|B|||
2395|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2395|100|I|medications work or increase your risk for serious side effects.||
2395|101|I|This document does not contain all possible drug interactions.||
2395|102|I|Keep a list of all the products you use (including||
2395|103|I|prescription/nonprescription drugs and herbal products) and share||
2395|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
2395|105|I|the dosage of any medicines without your doctor's approval.||
2395|106|I|   A product that may interact with this drug is: elacestrant.||
2395|107|I|   Other medications can affect the removal of voxelotor from||
2395|108|I|your body, which may affect how voxelotor works. Examples include||
2395|109|I|azole antifungals (such as fluconazole, ketoconazole), efavirenz,||
2395|110|I|macrolide antibiotics (such as erythromycin), St. John's wort,||
2395|111|I|drugs used to treat seizures (such as carbamazepine, phenytoin),||
2395|112|I|among others.||
2395|113|I|   This medication may interfere with certain lab tests, possibly||
2395|114|I|causing false test results. Make sure lab personnel and all your||
2395|115|I|doctors know you use this drug.||
2395|116|B|||
2395|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2395|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2395|119|O|poison control center right away. US residents can call||
2395|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2395|121|B|||
2395|122|N|NOTES:  Do not share this medication with others.||
2395|123|N|   Lab and/or medical tests (such as blood counts) should be done||
2395|124|N|while you are taking this medication. Keep all medical and lab||
2395|125|N|appointments.||
2395|126|B|||
2395|127|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2395|128|D|next dose at the regular time. Do not double the dose to catch||
2395|129|D|up.||
2395|130|D|   If you do not get a full dose of the medicine (for example, if||
2395|131|D|you are unable to drink all of the medicine in the cup), wait||
2395|132|D|until your next regularly scheduled dosage time to take a full||
2395|133|D|dose.||
2395|134|B|||
2395|135|R|STORAGE:  Store at room temperature away from light and moisture.||
2395|136|R|Do not store in the bathroom. Keep all medications away from||
2395|137|R|children and pets.||
2395|138|R|   Do not flush medications down the toilet or pour them into a||
2395|139|R|drain unless instructed to do so. Properly discard this product||
2395|140|R|when it is expired or no longer needed. Consult your pharmacist||
2395|141|R|or local waste disposal company.||
2395|142|B|||
2395|143|A|Information last revised October 2024.||
2395|144|A|Copyright(c) 2025 First Databank, Inc.||
2395|145|B|||
2396|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2396|002|Z|does NOT have all possible information about this product. This||
2396|003|Z|information does not assure that this product is safe, effective,||
2396|004|Z|or appropriate for you. This information is not individual||
2396|005|Z|medical advice and does not substitute for the advice of your||
2396|006|Z|health care professional. Always ask your health care||
2396|007|Z|professional for complete information about this product and your||
2396|008|Z|specific health needs.||
2396|009|B|||
2396|010|T|AVALGLUCOSIDASE ALFA - INJECTION||
2396|011|F|(AY-val-gloo-KOE-si-dase)||
2396|012|B|||
2396|013|C|COMMON BRAND NAME(S): Nexviazyme||
2396|014|B|||
2396|015|W|WARNING:  Avalglucosidase alfa may cause certain serious side||
2396|016|W|effects, including allergic and infusion reactions. Your doctor||
2396|017|W|may prescribe other medications (such as antihistamines,||
2396|018|W|corticosteroids) before each treatment to help prevent these side||
2396|019|W|effects. Get medical help right away if you have any symptoms of||
2396|020|W|a serious allergic reaction or infusion reactions such as||
2396|021|W|flushing/rash, itching/swelling (especially of the face, tongue,||
2396|022|W|throat), severe dizziness, trouble breathing, trouble swallowing,||
2396|023|W|cough, or chest discomfort/tightness. Your doctor may slow down||
2396|024|W|or stop your treatment for some time.||
2396|025|W|   Before starting treatment with this medication, tell your||
2396|026|W|doctor if you have a history of heart problems (such as heart||
2396|027|W|failure), breathing problems (such as fluid in the lungs), or||
2396|028|W|swelling. These problems may get worse during the infusion. Your||
2396|029|W|doctor may check your blood pressure, pulse (heart rate), and||
2396|030|W|breathing more often during your infusion.||
2396|031|B|||
2396|032|U|USES:  This medication is used by people with a certain inherited||
2396|033|U|condition (Pompe disease) to reduce high levels of a certain||
2396|034|U|substance (glycogen) that builds up in the body. High levels of||
2396|035|U|glycogen in the body may cause muscle weakness, heart problems,||
2396|036|U|and breathing problems. Avalglucosidase alfa works by breaking||
2396|037|U|down glycogen.||
2396|038|B|||
2396|039|H|HOW TO USE:  This medication is given by injection into a vein by||
2396|040|H|a health care professional. It is given as directed by your||
2396|041|H|doctor, usually once every 2 weeks. The dosage is based on your||
2396|042|H|weight, medical condition, and response to treatment. Your doctor||
2396|043|H|may prescribe other medications for you to take before treatment||
2396|044|H|to help lessen the risk of infusion reactions. Carefully follow||
2396|045|H|your doctor's directions. See also Warning section.||
2396|046|H|   Use this medication regularly to get the most benefit from it.||
2396|047|H|To help you remember, mark your calendar with a reminder.||
2396|048|B|||
2396|049|S|SIDE EFFECTS:  See also Warning section.||
2396|050|S|   Dizziness, muscle/joint pain, headache, diarrhea, nausea,||
2396|051|S|vomiting, or tiredness may also occur. If any of these effects||
2396|052|S|last or get worse, tell your doctor or pharmacist promptly.||
2396|053|S|   Remember that this medication has been prescribed because your||
2396|054|S|doctor has judged that the benefit to you is greater than the||
2396|055|S|risk of side effects. Many people using this medication do not||
2396|056|S|have serious side effects.||
2396|057|S|   Avalglucosidase alfa can commonly cause a rash that is usually||
2396|058|S|not serious. However, you may not be able to tell it apart from a||
2396|059|S|rare rash that could be a sign of a severe reaction. Get medical||
2396|060|S|help right away if you develop any rash.||
2396|061|S|   This is not a complete list of possible side effects. If you||
2396|062|S|notice other effects not listed above, contact your doctor or||
2396|063|S|pharmacist.||
2396|064|S|   In the US -||
2396|065|S|   Call your doctor for medical advice about side effects. You||
2396|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2396|067|S|www.fda.gov/medwatch.||
2396|068|S|   In Canada - Call your doctor for medical advice about side||
2396|069|S|effects. You may report side effects to Health Canada at||
2396|070|S|1-866-234-2345.||
2396|071|B|||
2396|072|P|PRECAUTIONS:  See also Warning section.||
2396|073|P|   Before using avalglucosidase alfa, tell your doctor or||
2396|074|P|pharmacist if you are allergic to it; or if you have any other||
2396|075|P|allergies. This product may contain inactive ingredients which||
2396|076|P|can cause allergic reactions or other problems. Talk to your||
2396|077|P|pharmacist for more details.||
2396|078|P|   Before using this medication, tell your doctor or pharmacist||
2396|079|P|your medical history.||
2396|080|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2396|081|P|can make you more dizzy. Do not drive, use machinery, or do||
2396|082|P|anything that needs alertness until you can do it safely. Limit||
2396|083|P|alcoholic beverages. Talk to your doctor if you are using||
2396|084|P|marijuana (cannabis).||
2396|085|P|   Before having surgery, tell your doctor or dentist about all||
2396|086|P|the products you use (including prescription drugs,||
2396|087|P|nonprescription drugs, and herbal products).||
2396|088|P|   During pregnancy, this medication should be used only when||
2396|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
2396|090|P|   It is unknown if this medication passes into breast milk.||
2396|091|P|Consult your doctor before breastfeeding.||
2396|092|B|||
2396|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2396|094|I|medications work or increase your risk for serious side effects.||
2396|095|I|This document does not contain all possible drug interactions.||
2396|096|I|Keep a list of all the products you use (including||
2396|097|I|prescription/nonprescription drugs and herbal products) and share||
2396|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
2396|099|I|the dosage of any medicines without your doctor's approval.||
2396|100|B|||
2396|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2396|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2396|103|O|poison control center right away. US residents can call||
2396|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2396|105|B|||
2396|106|N|NOTES:  Do not share this medication with others.||
2396|107|B|||
2396|108|D|MISSED DOSE:  It is important to get each dose of this medication||
2396|109|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2396|110|D|right away for a new dosing schedule.||
2396|111|B|||
2396|112|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2396|113|R|doctor's office and will not be stored at home.||
2396|114|B|||
2396|115|A|Information last revised October 2024.||
2396|116|A|Copyright(c) 2025 First Databank, Inc.||
2396|117|B|||
2397|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2397|002|Z|does NOT have all possible information about this product. This||
2397|003|Z|information does not assure that this product is safe, effective,||
2397|004|Z|or appropriate for you. This information is not individual||
2397|005|Z|medical advice and does not substitute for the advice of your||
2397|006|Z|health care professional. Always ask your health care||
2397|007|Z|professional for complete information about this product and your||
2397|008|Z|specific health needs.||
2397|009|B|||
2397|010|T|FARICIMAB - INTRAOCULAR||
2397|011|F|(far-IK-i-mab)||
2397|012|B|||
2397|013|C|COMMON BRAND NAME(S): Vabysmo||
2397|014|B|||
2397|015|U|USES:  Faricimab is used to treat certain serious eye conditions||
2397|016|U|(such as wet age-related macular degeneration, macular edema). It||
2397|017|U|is used to help prevent decreased vision and blindness. Faricimab||
2397|018|U|works by slowing the growth of abnormal new blood vessels in the||
2397|019|U|eye and decreasing leakage from these blood vessels.||
2397|020|B|||
2397|021|H|HOW TO USE:  This medication is prepared and given by injection||
2397|022|H|into the affected eye(s) by a health care professional. The||
2397|023|H|affected eye is numbed before each injection. After the||
2397|024|H|injection, you will remain in the doctor's office for a while,||
2397|025|H|and your eye(s) and vision will be monitored.||
2397|026|H|   The treatment schedule is based on your medical condition and||
2397|027|H|response to treatment. Your doctor will give you regularly||
2397|028|H|scheduled injections, usually once a month or every 4 weeks for||
2397|029|H|the first 4 doses, and then as determined by your doctor. For the||
2397|030|H|best effect, carefully follow your doctor's directions. Use this||
2397|031|H|medication regularly to get the most benefit from it.||
2397|032|H|   Tell your doctor if your condition gets worse.||
2397|033|B|||
2397|034|S|SIDE EFFECTS:  Eye irritation or discomfort may occur. If either||
2397|035|S|of these effects lasts or gets worse, tell your doctor or||
2397|036|S|pharmacist promptly.||
2397|037|S|   Remember that this medication has been prescribed because your||
2397|038|S|doctor has judged that the benefit to you is greater than the||
2397|039|S|risk of side effects. Many people using this medication do not||
2397|040|S|have serious side effects.||
2397|041|S|   Tell your doctor right away if you have any serious side||
2397|042|S|effects, including: floaters (blurry shapes that seem to float in||
2397|043|S|front of your eyes), swollen eyelids.||
2397|044|S|   Get medical help right away if you have any very serious side||
2397|045|S|effects, including: chest/jaw/left arm pain, unusual sweating,||
2397|046|S|weakness on one side of the body, trouble speaking, confusion.||
2397|047|S|   This medication may rarely increase your risk for developing||
2397|048|S|certain serious eye conditions (endophthalmitis, retinal||
2397|049|S|detachment, retinal vasculitis). Get medical help right away if||
2397|050|S|you notice any of these symptoms in the affected eye(s): pain,||
2397|051|S|redness, sensitivity to light, vision changes (such as blurred||
2397|052|S|vision, loss of vision).||
2397|053|S|   A very serious allergic reaction to this drug is rare.||
2397|054|S|However, get medical help right away if you notice any symptoms||
2397|055|S|of a serious allergic reaction, including: rash, itching/swelling||
2397|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2397|057|S|breathing.||
2397|058|S|   This is not a complete list of possible side effects. If you||
2397|059|S|notice other effects not listed above, contact your doctor or||
2397|060|S|pharmacist.||
2397|061|S|   In the US -||
2397|062|S|   Call your doctor for medical advice about side effects. You||
2397|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2397|064|S|www.fda.gov/medwatch.||
2397|065|S|   In Canada - Call your doctor for medical advice about side||
2397|066|S|effects. You may report side effects to Health Canada at||
2397|067|S|1-866-234-2345.||
2397|068|B|||
2397|069|P|PRECAUTIONS:  Before using faricimab, tell your doctor or||
2397|070|P|pharmacist if you are allergic to it; or if you have any other||
2397|071|P|allergies. This product may contain inactive ingredients, which||
2397|072|P|can cause allergic reactions or other problems. Talk to your||
2397|073|P|pharmacist for more details.||
2397|074|P|   Before using this medication, tell your doctor or pharmacist||
2397|075|P|your medical history, especially of: current eye||
2397|076|P|infection/swelling.||
2397|077|P|   This drug may cause blurred vision. Do not drive, use||
2397|078|P|machinery, or do anything that needs clear vision until you can||
2397|079|P|do it safely.||
2397|080|P|   Before having surgery, tell your doctor or dentist about all||
2397|081|P|the products you use (including prescription drugs,||
2397|082|P|nonprescription drugs, and herbal products).||
2397|083|P|   Tell your doctor if you are pregnant or plan to become||
2397|084|P|pregnant. You should not become pregnant while using faricimab.||
2397|085|P|Faricimab may harm an unborn baby. Your doctor should order a||
2397|086|P|pregnancy test before you start this medication. Ask about||
2397|087|P|reliable forms of birth control while using this medication and||
2397|088|P|for 3 months after the last dose. If you become pregnant, talk to||
2397|089|P|your doctor right away about the risks and benefits of this||
2397|090|P|medication.||
2397|091|P|   It is unknown if this medication passes into breast milk.||
2397|092|P|Consult your doctor before breastfeeding.||
2397|093|B|||
2397|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2397|095|I|medications work or increase your risk for serious side effects.||
2397|096|I|This document does not contain all possible drug interactions.||
2397|097|I|Keep a list of all the products you use (including||
2397|098|I|prescription/nonprescription drugs and herbal products) and share||
2397|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2397|100|I|the dosage of any medicines without your doctor's approval.||
2397|101|B|||
2397|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2397|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2397|104|O|poison control center right away. US residents can call||
2397|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2397|106|B|||
2397|107|N|NOTES:  Medical tests (such as eye exams) should be done while||
2397|108|N|you are using this medication. Keep all medical appointments.||
2397|109|N|Consult your doctor for more details.||
2397|110|B|||
2397|111|D|MISSED DOSE:  It is important to get each dose of this medication||
2397|112|D|as scheduled. If you miss a dose, ask your doctor right away for||
2397|113|D|a new dosing schedule.||
2397|114|B|||
2397|115|R|STORAGE:  Not applicable. This medication is given in a hospital||
2397|116|R|or doctor's office and will not be stored at home.||
2397|117|B|||
2397|118|A|Information last revised May 2024.||
2397|119|A|Copyright(c) 2025 First Databank, Inc.||
2397|120|B|||
2398|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2398|002|Z|does NOT have all possible information about this product. This||
2398|003|Z|information does not assure that this product is safe, effective,||
2398|004|Z|or appropriate for you. This information is not individual||
2398|005|Z|medical advice and does not substitute for the advice of your||
2398|006|Z|health care professional. Always ask your health care||
2398|007|Z|professional for complete information about this product and your||
2398|008|Z|specific health needs.||
2398|009|B|||
2398|010|T|TEBENTAFUSP - INJECTION||
2398|011|F|(te-BEN-ta-fusp)||
2398|012|B|||
2398|013|C|COMMON BRAND NAME(S): Kimmtrak||
2398|014|B|||
2398|015|W|WARNING:  Tebentafusp may cause a certain serious (sometimes||
2398|016|W|fatal) side effect known as cytokine release syndrome-CRS. You||
2398|017|W|will be given this medication in a hospital or clinic so your||
2398|018|W|doctor can watch for serious side effects and quickly provide||
2398|019|W|treatment if needed. You will be monitored for at least 16 hours||
2398|020|W|after the first 3 treatments. You will be monitored for at least||
2398|021|W|30 minutes after later treatments. Tell your doctor right away if||
2398|022|W|you develop symptoms such as fever, chills, headache, nausea,||
2398|023|W|vomiting, stomach/abdominal pain, trouble breathing, skin rash,||
2398|024|W|tiredness, or low blood pressure.||
2398|025|W|   If you have side effects, your doctor may temporarily stop or||
2398|026|W|slow down your treatment with this medication. Your doctor may||
2398|027|W|also prescribe other medications before you receive tebentafusp||
2398|028|W|to decrease the risk of side effects.||
2398|029|B|||
2398|030|U|USES:  This medication is used to treat a certain type of cancer||
2398|031|U|(uveal melanoma). Tebentafusp belongs to a class of drugs known||
2398|032|U|as monoclonal antibodies. It works by slowing or stopping the||
2398|033|U|growth of cancer cells.||
2398|034|B|||
2398|035|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2398|036|H|from your pharmacist before you start using tebentafusp and each||
2398|037|H|time you get a refill. If you have any questions, ask your doctor||
2398|038|H|or pharmacist.||
2398|039|H|   This medication is given by injection into a vein as directed||
2398|040|H|by your doctor, usually once a week. The injection is given by a||
2398|041|H|health care professional, usually over 15 to 20 minutes. The||
2398|042|H|dosage is based on your medical condition and response to||
2398|043|H|treatment. To reduce your risk of side effects, your doctor may||
2398|044|H|prescribe other medications (such as dexamethasone) before each||
2398|045|H|treatment to help reduce side effects. Also, your doctor may||
2398|046|H|start this medication at a low dose and gradually increase your||
2398|047|H|dose.||
2398|048|B|||
2398|049|S|SIDE EFFECTS:  See also Warning section.||
2398|050|S|   Dry/itchy skin, loss of color in the skin, hair color changes,||
2398|051|S|swelling ankles/feet/hands, or muscle/joint pain may occur. If||
2398|052|S|any of these effects last or get worse, tell your doctor or||
2398|053|S|pharmacist promptly.||
2398|054|S|   People using this medication may have serious side effects.||
2398|055|S|However, you have been prescribed this drug because your doctor||
2398|056|S|has judged that the benefit to you is greater than the risk of||
2398|057|S|side effects. Careful monitoring by your doctor may decrease your||
2398|058|S|risk.||
2398|059|S|   Tell your doctor right away if you have any serious side||
2398|060|S|effects, including: signs of liver problems (such as||
2398|061|S|nausea/vomiting that doesn't stop, loss of appetite,||
2398|062|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2398|063|S|   Tebentafusp can commonly cause skin redness, itching,||
2398|064|S|swelling, or a rash that are usually not serious. However, you||
2398|065|S|may not be able to tell it apart from a rare rash that could be a||
2398|066|S|sign of a severe reaction. Tell your doctor right away if you||
2398|067|S|develop any rash.||
2398|068|S|   A very serious allergic reaction to this drug is rare.||
2398|069|S|However, get medical help right away if you notice any symptoms||
2398|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2398|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2398|072|S|breathing.||
2398|073|S|   This is not a complete list of possible side effects. If you||
2398|074|S|notice other effects not listed above, contact your doctor or||
2398|075|S|pharmacist.||
2398|076|S|   In the US -||
2398|077|S|   Call your doctor for medical advice about side effects. You||
2398|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2398|079|S|www.fda.gov/medwatch.||
2398|080|S|   In Canada - Call your doctor for medical advice about side||
2398|081|S|effects. You may report side effects to Health Canada at||
2398|082|S|1-866-234-2345.||
2398|083|B|||
2398|084|P|PRECAUTIONS:  Before using tebentafusp, tell your doctor or||
2398|085|P|pharmacist if you are allergic to it; or if you have any other||
2398|086|P|allergies. This product may contain inactive ingredients, which||
2398|087|P|can cause allergic reactions or other problems. Talk to your||
2398|088|P|pharmacist for more details.||
2398|089|P|   Before using this medication, tell your doctor or pharmacist||
2398|090|P|your medical history.||
2398|091|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2398|092|P|can make you more dizzy. Do not drive, use machinery, or do||
2398|093|P|anything that needs alertness until you can do it safely. Limit||
2398|094|P|alcoholic beverages. Talk to your doctor if you are using||
2398|095|P|marijuana (cannabis).||
2398|096|P|   Before having surgery, tell your doctor or dentist about all||
2398|097|P|the products you use (including prescription drugs,||
2398|098|P|nonprescription drugs, and herbal products).||
2398|099|P|   Tell your doctor if you are pregnant or plan to become||
2398|100|P|pregnant. You should not become pregnant while using tebentafusp.||
2398|101|P|Tebentafusp may harm an unborn baby. Your doctor should order a||
2398|102|P|pregnancy test before you start this medication. Ask about||
2398|103|P|reliable forms of birth control while using this medication and||
2398|104|P|for 1 week after the last dose. If you become pregnant, talk to||
2398|105|P|your doctor right away about the risks and benefits of this||
2398|106|P|medication.||
2398|107|P|   It is unknown if this drug passes into breast milk. Because of||
2398|108|P|the possible risk to the infant, breastfeeding is not recommended||
2398|109|P|while using this drug and for at least 1 week after the last||
2398|110|P|dose. Consult your doctor before breastfeeding.||
2398|111|B|||
2398|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2398|113|I|medications work or increase your risk for serious side effects.||
2398|114|I|This document does not contain all possible drug interactions.||
2398|115|I|Keep a list of all the products you use (including||
2398|116|I|prescription/nonprescription drugs and herbal products) and share||
2398|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
2398|118|I|the dosage of any medicines without your doctor's approval.||
2398|119|B|||
2398|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2398|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2398|122|O|poison control center right away. US residents can call||
2398|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2398|124|B|||
2398|125|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2398|126|N|liver function) should be done while you are using this||
2398|127|N|medication. Keep all medical and lab appointments.||
2398|128|B|||
2398|129|D|MISSED DOSE:  It is important to get each dose of this medication||
2398|130|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2398|131|D|right away for a new dosing schedule.||
2398|132|B|||
2398|133|R|STORAGE:  Not applicable. This medication is given in a hospital||
2398|134|R|or clinic and will not be stored at home.||
2398|135|B|||
2398|136|A|Information last revised September 2024.||
2398|137|A|Copyright(c) 2025 First Databank, Inc.||
2398|138|B|||
2399|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2399|002|Z|does NOT have all possible information about this product. This||
2399|003|Z|information does not assure that this product is safe, effective,||
2399|004|Z|or appropriate for you. This information is not individual||
2399|005|Z|medical advice and does not substitute for the advice of your||
2399|006|Z|health care professional. Always ask your health care||
2399|007|Z|professional for complete information about this product and your||
2399|008|Z|specific health needs.||
2399|009|B|||
2399|010|T|FERRIC DERISOMALTOSE - INJECTION||
2399|011|F|(FER-ik der-EYE-so-MAWL-tose)||
2399|012|B|||
2399|013|C|COMMON BRAND NAME(S): Monoferric||
2399|014|B|||
2399|015|U|USES:  This medication is used to treat "iron-poor" blood (iron||
2399|016|U|deficiency anemia). Low iron levels can occur due to many||
2399|017|U|conditions, including when your body cannot get enough iron from||
2399|018|U|food (because of poor nutrition or poor absorption) or when there||
2399|019|U|is long-term blood loss. Ferric derisomaltose is a form of||
2399|020|U|injectable iron that is used if you cannot take iron by mouth||
2399|021|U|because of side effects or an unsuccessful response to treatment.||
2399|022|U|It is also used by people who have anemia due to long-term kidney||
2399|023|U|disease.||
2399|024|U|   Iron is an important mineral that your body needs to make||
2399|025|U|enough healthy red blood cells to carry oxygen throughout your||
2399|026|U|body.||
2399|027|B|||
2399|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2399|029|H|from your pharmacist before you start using ferric derisomaltose||
2399|030|H|and with each treatment. If you have any questions, ask your||
2399|031|H|doctor or pharmacist.||
2399|032|H|   This medication is given by injection into a vein by a health||
2399|033|H|care professional. It is given as directed by your doctor,||
2399|034|H|usually once as a single dose. It is injected slowly into a vein||
2399|035|H|over at least 20 minutes.||
2399|036|H|   The dosage is based on your medical condition, weight, and||
2399|037|H|response to treatment. Your doctor will order lab tests to||
2399|038|H|monitor your response.||
2399|039|B|||
2399|040|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
2399|041|S|because your doctor has judged that the benefit to you is greater||
2399|042|S|than the risk of side effects. Many people using this medication||
2399|043|S|do not have serious side effects.||
2399|044|S|   A rare but very serious, possibly fatal, allergic reaction may||
2399|045|S|occur with this medication. You should be monitored during the||
2399|046|S|dose and for at least 30 minutes afterward. Get medical help||
2399|047|S|right away if you notice any symptoms of a serious allergic||
2399|048|S|reaction, including: rash, itching/swelling (especially of the||
2399|049|S|face/tongue/throat), severe dizziness, trouble breathing, loss of||
2399|050|S|consciousness.||
2399|051|S|   This is not a complete list of possible side effects. If you||
2399|052|S|notice other effects not listed above, contact your doctor or||
2399|053|S|pharmacist.||
2399|054|S|   In the US -||
2399|055|S|   Call your doctor for medical advice about side effects. You||
2399|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2399|057|S|www.fda.gov/medwatch.||
2399|058|S|   In Canada - Call your doctor for medical advice about side||
2399|059|S|effects. You may report side effects to Health Canada at||
2399|060|S|1-866-234-2345.||
2399|061|B|||
2399|062|P|PRECAUTIONS:  Before using ferric derisomaltose, tell your doctor||
2399|063|P|or pharmacist if you are allergic to it; or to other iron||
2399|064|P|injection products; or if you have any other allergies. This||
2399|065|P|product may contain inactive ingredients, which can cause||
2399|066|P|allergic reactions or other problems. Talk to your pharmacist for||
2399|067|P|more details.||
2399|068|P|   Before using this medication, tell your doctor or pharmacist||
2399|069|P|your medical history.||
2399|070|P|   Before having surgery, tell your doctor or dentist about all||
2399|071|P|the products you use (including prescription drugs,||
2399|072|P|nonprescription drugs, and herbal products).||
2399|073|P|   During pregnancy, this medication should be used only when||
2399|074|P|clearly needed. Discuss the risks and benefits with your doctor.||
2399|075|P|   This medication passes into breast milk. Consult your doctor||
2399|076|P|before breastfeeding.||
2399|077|B|||
2399|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2399|079|I|medications work or increase your risk for serious side effects.||
2399|080|I|This document does not contain all possible drug interactions.||
2399|081|I|Keep a list of all the products you use (including||
2399|082|I|prescription/nonprescription drugs and herbal products) and share||
2399|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
2399|084|I|the dosage of any medicines without your doctor's approval.||
2399|085|I|   Some products that may interact with this drug are:||
2399|086|I|dimercaprol, other iron-containing products.||
2399|087|B|||
2399|088|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2399|089|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2399|090|O|poison control center right away. US residents can call||
2399|091|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2399|092|B|||
2399|093|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2399|094|N|iron levels) should be done while you are using this medication.||
2399|095|N|Keep all medical and lab appointments.||
2399|096|N|   It is important to eat a well-balanced diet that has enough||
2399|097|N|iron, vitamins, and minerals. Good sources of iron include meats||
2399|098|N|(especially liver), eggs, raisins, figs, broccoli, brussels||
2399|099|N|sprouts, beans, lentils, and iron-fortified or enriched cereals.||
2399|100|N|Follow any diet recommendations given to you by your doctor.||
2399|101|B|||
2399|102|D|MISSED DOSE:  Not applicable.||
2399|103|B|||
2399|104|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2399|105|R|doctor's office and will not be stored at home.||
2399|106|B|||
2399|107|A|Information last revised May 2024.||
2399|108|A|Copyright(c) 2025 First Databank, Inc.||
2399|109|B|||
2400|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2400|002|Z|does NOT have all possible information about this product. This||
2400|003|Z|information does not assure that this product is safe, effective,||
2400|004|Z|or appropriate for you. This information is not individual||
2400|005|Z|medical advice and does not substitute for the advice of your||
2400|006|Z|health care professional. Always ask your health care||
2400|007|Z|professional for complete information about this product and your||
2400|008|Z|specific health needs.||
2400|009|B|||
2400|010|T|ABROCITINIB - ORAL||
2400|011|F|(A-broe-SYE-ti-nib)||
2400|012|B|||
2400|013|C|COMMON BRAND NAME(S): Cibinqo||
2400|014|B|||
2400|015|W|WARNING:  Abrocitinib may lower your ability to fight infections.||
2400|016|W|This may make you more likely to get a serious (rarely fatal)||
2400|017|W|infection or make any infection you have worse. The most common||
2400|018|W|serious infections include pneumonia, shingles, herpes in the||
2400|019|W|mouth/eye/skin/genitals. The risk for infections may be higher if||
2400|020|W|you also take other drugs that suppress the immune system (such||
2400|021|W|as cyclosporine, tacrolimus). Tell your doctor right away if you||
2400|022|W|have any signs of infection (such as sore throat that doesn't go||
2400|023|W|away, fever, chills, cough, trouble breathing, non-healing skin||
2400|024|W|sores).||
2400|025|W|   You should have a tuberculosis (TB) skin test before and||
2400|026|W|during treatment with this medication. Tell your doctor if you||
2400|027|W|have been near someone with tuberculosis or have lived or||
2400|028|W|traveled in areas where certain fungal infections (such as||
2400|029|W|coccidioidomycosis, histoplasmosis) are common. These areas||
2400|030|W|include the Ohio and Mississippi River valleys and the||
2400|031|W|southwestern United States.||
2400|032|W|   Though it is very unlikely to occur, there may be a risk of||
2400|033|W|developing cancer (such as lymphoma, skin cancer, lung cancer)||
2400|034|W|with this medication. Your risk may be higher if you are a||
2400|035|W|current or past smoker. Tell your doctor right away if you||
2400|036|W|develop symptoms such as fever or cough that doesn't go away,||
2400|037|W|wheezing, unusual lumps/growths, unexplained weight loss, night||
2400|038|W|sweats, change in appearance or size of moles, or unusual skin||
2400|039|W|changes.||
2400|040|W|   Abrocitinib may cause serious (sometimes fatal) problems from||
2400|041|W|blood clots (such as heart attack, stroke, blood clots in the||
2400|042|W|lungs or legs). You may be at an increased risk for blood clots||
2400|043|W|if you are a current or past smoker, or are 50 years of age or||
2400|044|W|older and have at least one risk factor for heart disease.||
2400|045|W|Discuss the risks and benefits of treatment with your doctor. Get||
2400|046|W|medical help right away if any of these side effects occur:||
2400|047|W|shortness of breath/rapid breathing, chest/jaw/left arm pain,||
2400|048|W|unusual sweating, confusion, sudden dizziness/fainting,||
2400|049|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2400|050|W|trouble speaking, weakness on one side of the body, or sudden||
2400|051|W|vision changes.||
2400|052|B|||
2400|053|U|USES:  Abrocitinib is used to treat a certain moderate-to-severe||
2400|054|U|skin rash (dermatitis) that is not controlled with other||
2400|055|U|treatments. Abrocitinib belongs to a class of drugs known as||
2400|056|U|Janus kinase (JAK) inhibitors.||
2400|057|B|||
2400|058|H|HOW TO USE:  Read the Medication Guide provided by your||
2400|059|H|pharmacist before you start taking abrocitinib and each time you||
2400|060|H|get a refill. If you have any questions, ask your doctor or||
2400|061|H|pharmacist.||
2400|062|H|   Take this medication by mouth with or without food as directed||
2400|063|H|by your doctor, usually once daily. The manufacturer directs not||
2400|064|H|to crush, split, or chew the tablet before taking it. However,||
2400|065|H|many similar drugs (immediate-release tablets) can be split,||
2400|066|H|crushed, or chewed. Follow your doctor's directions on how to||
2400|067|H|take this medication.||
2400|068|H|   The dosage is based on your medical condition, response to||
2400|069|H|treatment, and other medications you may be taking. Be sure to||
2400|070|H|tell your doctor and pharmacist about all the products you use||
2400|071|H|(including prescription drugs, nonprescription drugs, and herbal||
2400|072|H|products). Do not increase your dose or use this drug more often||
2400|073|H|or for longer than prescribed. Your condition will not improve||
2400|074|H|any faster, and your risk of serious side effects will increase.||
2400|075|H|   Take this medication regularly to get the most benefit from||
2400|076|H|it. Remember to take it at the same time each day.||
2400|077|H|   Tell your doctor if your condition does not get better or if||
2400|078|H|it gets worse.||
2400|079|B|||
2400|080|S|SIDE EFFECTS:  See also Warning section.||
2400|081|S|   Nausea, headache, dizziness, or tiredness may occur. If any of||
2400|082|S|these effects last or get worse, tell your doctor or pharmacist||
2400|083|S|promptly.||
2400|084|S|   People using this medication may have serious side effects.||
2400|085|S|However, you have been prescribed this drug because your doctor||
2400|086|S|has judged that the benefit to you is greater than the risk of||
2400|087|S|side effects. Careful monitoring by your doctor may decrease your||
2400|088|S|risk.||
2400|089|S|   Get medical help right away if you have any very serious side||
2400|090|S|effects, including: vision changes (such as blurred vision,||
2400|091|S|seeing flashes of light).||
2400|092|S|   A very serious allergic reaction to this drug is rare.||
2400|093|S|However, get medical help right away if you notice any symptoms||
2400|094|S|of a serious allergic reaction, including: rash, itching/swelling||
2400|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2400|096|S|breathing.||
2400|097|S|   This is not a complete list of possible side effects. If you||
2400|098|S|notice other effects not listed above, contact your doctor or||
2400|099|S|pharmacist.||
2400|100|S|   In the US -||
2400|101|S|   Call your doctor for medical advice about side effects. You||
2400|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2400|103|S|www.fda.gov/medwatch.||
2400|104|S|   In Canada - Call your doctor for medical advice about side||
2400|105|S|effects. You may report side effects to Health Canada at||
2400|106|S|1-866-234-2345.||
2400|107|B|||
2400|108|P|PRECAUTIONS:  See also Warning section.||
2400|109|P|   Before taking abrocitinib, tell your doctor or pharmacist if||
2400|110|P|you are allergic to it; or if you have any other allergies. This||
2400|111|P|product may contain inactive ingredients, which can cause||
2400|112|P|allergic reactions or other problems. Talk to your pharmacist for||
2400|113|P|more details.||
2400|114|P|   Before using this medication, tell your doctor or pharmacist||
2400|115|P|your medical history, especially of: blood clots (such as in the||
2400|116|P|lungs, legs), blood/bone marrow disorders (such as anemia, low||
2400|117|P|blood cell count), cancer, eye problems (such as cataracts,||
2400|118|P|retinal detachment), heart problems (such as previous heart||
2400|119|P|attack), kidney disease, liver disease (such as hepatitis B or||
2400|120|P|C), past/recent/current infections (such as tuberculosis, herpes||
2400|121|P|zoster, HIV infection), current or past smoking, stroke.||
2400|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2400|123|P|can make you more dizzy. Do not drive, use machinery, or do||
2400|124|P|anything that needs alertness until you can do it safely. Limit||
2400|125|P|alcoholic beverages. Talk to your doctor if you are using||
2400|126|P|marijuana (cannabis).||
2400|127|P|   Abrocitinib can make you more likely to get infections or may||
2400|128|P|make current infections worse. Stay away from anyone who has an||
2400|129|P|infection that may easily spread (such as chickenpox, COVID-19,||
2400|130|P|measles, flu). Talk to your doctor if you have been exposed to an||
2400|131|P|infection or for more details.||
2400|132|P|   Tell your health care professional that you are using||
2400|133|P|abrocitinib before having any immunizations/vaccinations. Avoid||
2400|134|P|contact with people who have recently received live vaccines||
2400|135|P|(such as flu vaccine inhaled through the nose).||
2400|136|P|   This medication may increase your risk of developing skin||
2400|137|P|cancer. Limit your time in the sun. Avoid tanning booths and||
2400|138|P|sunlamps. Use sunscreen and wear protective clothing when||
2400|139|P|outdoors.||
2400|140|P|   Before having surgery, tell your doctor or dentist about all||
2400|141|P|the products you use (including prescription drugs,||
2400|142|P|nonprescription drugs, and herbal products).||
2400|143|P|   During pregnancy, this medication should be used only when||
2400|144|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2400|145|P|benefits with your doctor.||
2400|146|P|   It is unknown if this medication passes into breast milk.||
2400|147|P|Because of the possible risk to the infant, breastfeeding is not||
2400|148|P|recommended while using this medication and for at least 1 day||
2400|149|P|after the last dose. Consult your doctor before breastfeeding.||
2400|150|B|||
2400|151|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2400|152|I|medications work or increase your risk for serious side effects.||
2400|153|I|This document does not contain all possible drug interactions.||
2400|154|I|Keep a list of all the products you use (including||
2400|155|I|prescription/nonprescription drugs and herbal products) and share||
2400|156|I|it with your doctor and pharmacist. Do not start, stop, or change||
2400|157|I|the dosage of any medicines without your doctor's approval.||
2400|158|I|   A product that may interact with this drug is: fluconazole.||
2400|159|I|   During the first three months of treatment, avoid taking drugs||
2400|160|I|that may increase the risk of bleeding. However, if your doctor||
2400|161|I|has told you to take low-dose aspirin to prevent heart attack or||
2400|162|I|stroke (usually 81-162 milligrams a day), you should keep taking||
2400|163|I|the aspirin unless your doctor tells you not to. Ask your doctor||
2400|164|I|or pharmacist for more details.||
2400|165|B|||
2400|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2400|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2400|168|O|poison control center right away. US residents can call||
2400|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2400|170|B|||
2400|171|N|NOTES:  Do not share this medication with others.||
2400|172|N|   Lab and/or medical tests (such as complete blood count,||
2400|173|N|kidney/liver function, cholesterol levels, skin exams) should be||
2400|174|N|done while you are using this medication. Keep all medical and||
2400|175|N|lab appointments.||
2400|176|B|||
2400|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2400|178|D|remember. If it is less than 12 hours before the next dose, skip||
2400|179|D|the missed dose. Take your next dose at the regular time. Do not||
2400|180|D|double the dose to catch up.||
2400|181|B|||
2400|182|R|STORAGE:  Store in the original package at room temperature away||
2400|183|R|from light and moisture. Do not store in the bathroom. Keep all||
2400|184|R|medications away from children and pets.||
2400|185|R|   Do not flush medications down the toilet or pour them into a||
2400|186|R|drain unless instructed to do so. Properly discard this product||
2400|187|R|when it is expired or no longer needed. Consult your pharmacist||
2400|188|R|or local waste disposal company.||
2400|189|B|||
2400|190|M|MEDICAL ALERT:  Your condition can cause complications in a||
2400|191|M|medical emergency. For information about enrolling in MedicAlert,||
2400|192|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2400|193|B|||
2400|194|A|Information last revised April 2025.||
2400|195|A|Copyright(c) 2025 First Databank, Inc.||
2400|196|B|||
2402|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2402|002|Z|does NOT have all possible information about this product. This||
2402|003|Z|information does not assure that this product is safe, effective,||
2402|004|Z|or appropriate for you. This information is not individual||
2402|005|Z|medical advice and does not substitute for the advice of your||
2402|006|Z|health care professional. Always ask your health care||
2402|007|Z|professional for complete information about this product and your||
2402|008|Z|specific health needs.||
2402|009|B|||
2402|010|T|TRAMADOL/CELECOXIB - ORAL||
2402|011|F|(TRAM-a-dol/SEL-e-KOX-ib)||
2402|012|B|||
2402|013|C|COMMON BRAND NAME(S): Seglentis||
2402|014|B|||
2402|015|W|WARNING:  Tramadol/celecoxib has a risk for abuse and addiction,||
2402|016|W|which can lead to overdose and death. Tramadol/celecoxib may also||
2402|017|W|cause severe, possibly fatal, breathing problems. To lower your||
2402|018|W|risk, your doctor should have you take the smallest dose of the||
2402|019|W|medication that works and take it for the shortest possible time.||
2402|020|W|See also How to Use section for more information about addiction.||
2402|021|W|   Ask your doctor or pharmacist if you should have medication||
2402|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
2402|023|W|Teach your family or household members about the signs of an||
2402|024|W|opioid overdose and how to treat it.||
2402|025|W|   The risk for severe breathing problems is higher when you||
2402|026|W|start this medication and after a dose increase, or if you take||
2402|027|W|the wrong dose/strength. Taking this medication with alcohol or||
2402|028|W|other drugs that can cause drowsiness or breathing problems may||
2402|029|W|cause very serious side effects, including death. Also, other||
2402|030|W|medications can affect the removal of tramadol/celecoxib from||
2402|031|W|your body, which may affect how it works. Be sure you know how to||
2402|032|W|take this medication and what other drugs you should avoid taking||
2402|033|W|with it. See also Drug Interactions section. Get medical help||
2402|034|W|right away if any of these very serious side effects occur:||
2402|035|W|slow/shallow breathing, unusual lightheadedness, severe||
2402|036|W|drowsiness/dizziness, difficulty waking up.||
2402|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
2402|038|W|or abuse. If someone accidentally swallows this drug, get medical||
2402|039|W|help right away.||
2402|040|W|   Nonsteroidal anti-inflammatory drugs (including celecoxib) may||
2402|041|W|rarely increase the risk of a heart attack or stroke. This effect||
2402|042|W|can happen at any time while taking this drug but is more likely||
2402|043|W|if you take it for a long time. The risk may be greater in older||
2402|044|W|adults or if you have heart disease or increased risk for heart||
2402|045|W|disease (for example, due to smoking, family history of heart||
2402|046|W|disease, or conditions such as high blood pressure or diabetes).||
2402|047|W|Do not take this drug right before or after heart bypass surgery||
2402|048|W|(CABG).||
2402|049|W|   Also, celecoxib may rarely cause serious (rarely fatal)||
2402|050|W|bleeding from the stomach or intestines. This effect can occur||
2402|051|W|without warning symptoms at any time while taking this drug.||
2402|052|W|Older adults may be at higher risk for this effect. (See also||
2402|053|W|Precautions and Drug Interactions sections.)||
2402|054|W|   Stop taking this medication and get medical help right away if||
2402|055|W|you notice any of these rare but serious side effects:||
2402|056|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
2402|057|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
2402|058|W|shortness of breath, unusual sweating, confusion, weakness on one||
2402|059|W|side of the body, trouble speaking, sudden vision changes.||
2402|060|W|   Before using this medication, women of childbearing age should||
2402|061|W|talk with their doctor(s) about the benefits and risks. Tell your||
2402|062|W|doctor if you are pregnant or if you plan to become pregnant.||
2402|063|W|This medication may harm an unborn baby and cause problems with||
2402|064|W|normal labor/delivery. It is not recommended for use in pregnancy||
2402|065|W|from 20 weeks until delivery. If your doctor decides that you||
2402|066|W|need to use this medication between 20 and 30 weeks of pregnancy,||
2402|067|W|you should use the lowest effective dose for the shortest||
2402|068|W|possible time. You should not use this medication after 30 weeks||
2402|069|W|of pregnancy. Babies born to mothers who use this drug for a long||
2402|070|W|time may develop severe (possibly fatal) withdrawal symptoms.||
2402|071|W|Tell the doctor right away if you notice any symptoms in your||
2402|072|W|newborn baby such as crying that doesn't stop, slow/shallow||
2402|073|W|breathing, irritability, shaking, vomiting, diarrhea, poor||
2402|074|W|feeding, or difficulty gaining weight.||
2402|075|W|   Children younger than 18 years should not use products that||
2402|076|W|contain tramadol. Some children are more sensitive to tramadol||
2402|077|W|and have had very serious (rarely fatal) breathing problems such||
2402|078|W|as slow/shallow breathing (see also Side Effects section). The||
2402|079|W|risk is greater in children who are obese or have breathing||
2402|080|W|problems, or after certain surgeries (including tonsil/adenoid||
2402|081|W|removal). Talk with your doctor or pharmacist about the risks and||
2402|082|W|benefits of this medication.||
2402|083|B|||
2402|084|U|USES:  See also Warning section.||
2402|085|U|   This product is used to help relieve moderate to severe acute||
2402|086|U|pain. It is for use by people who cannot take or who do not get||
2402|087|U|pain relief from non-opioid analgesics (such as acetaminophen or||
2402|088|U|ibuprofen).||
2402|089|U|   This medication contains 2 ingredients: tramadol and||
2402|090|U|celecoxib. Tramadol belongs to a class of drugs known as opioid||
2402|091|U|analgesics. It works in the brain to change how your body feels||
2402|092|U|and responds to pain. Celecoxib is known as a nonsteroidal||
2402|093|U|anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor.||
2402|094|U|It works by blocking your body's production of certain natural||
2402|095|U|substances that cause inflammation. This effect helps to decrease||
2402|096|U|pain and swelling.||
2402|097|B|||
2402|098|H|HOW TO USE:  Read the Medication Guide provided by your||
2402|099|H|pharmacist before you start taking this product and each time you||
2402|100|H|get a refill. If you have any questions, ask your doctor or||
2402|101|H|pharmacist.||
2402|102|H|   Take this medication by mouth as directed by your doctor,||
2402|103|H|usually every 12 hours as needed for pain relief. Take this||
2402|104|H|medication with a full glass of water (8 ounces/240 milliliters)||
2402|105|H|unless your doctor directs you otherwise. Do not lie down for at||
2402|106|H|least 10 minutes after taking this medication.||
2402|107|H|   You may take this drug with or without food. To decrease the||
2402|108|H|chance of stomach upset or nausea, this drug is best taken with||
2402|109|H|food. Ask your doctor or pharmacist about other ways to decrease||
2402|110|H|nausea (such as lying down for 1 to 2 hours with as little head||
2402|111|H|movement as possible).||
2402|112|H|   The dosage is based on your medical condition and response to||
2402|113|H|treatment. To reduce your risk of side effects, your doctor may||
2402|114|H|direct you to start this medication at a low dose and gradually||
2402|115|H|increase your dose. Follow your doctor's instructions carefully.||
2402|116|H|The maximum recommended dose is 2 tablets every 12 hours. Do not||
2402|117|H|increase your dose, take the medication more often, or take it||
2402|118|H|for a longer time than prescribed. Properly stop the medication||
2402|119|H|when so directed.||
2402|120|H|   Pain medications work best if they are used as the first signs||
2402|121|H|of pain occur. If you wait until the pain has worsened, the||
2402|122|H|medication may not work as well.||
2402|123|H|   Suddenly stopping this medication may cause withdrawal,||
2402|124|H|especially if you have used it for a long time or in high doses.||
2402|125|H|To prevent withdrawal, your doctor may lower your dose slowly.||
2402|126|H|Tell your doctor or pharmacist right away if you have any||
2402|127|H|withdrawal symptoms such as restlessness, mental/mood changes||
2402|128|H|(including anxiety, trouble sleeping, thoughts of suicide),||
2402|129|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
2402|130|H|aches, or sudden changes in behavior.||
2402|131|H|   When this medication is used for a long time, it may not work||
2402|132|H|as well. Talk with your doctor if this medication stops working||
2402|133|H|well.||
2402|134|H|   Though it helps many people, this medication may sometimes||
2402|135|H|cause addiction. This risk may be higher if you have a||
2402|136|H|mental/mood disorder or a substance use disorder (such as overuse||
2402|137|H|of or addiction to drugs/alcohol). Take this medication exactly||
2402|138|H|as prescribed to lower the risk of addiction. Ask your doctor or||
2402|139|H|pharmacist for more details.||
2402|140|H|   Tell your doctor if your pain does not get better or if it||
2402|141|H|gets worse, or if you have any new pain.||
2402|142|B|||
2402|143|S|SIDE EFFECTS:  See also Warning section.||
2402|144|S|   Nausea, vomiting, stomach upset, gas, constipation,||
2402|145|S|lightheadedness, dizziness, drowsiness, or headache may occur.||
2402|146|S|Some of these side effects may decrease after you have been using||
2402|147|S|this medication for a while. If any of these effects last or get||
2402|148|S|worse, tell your doctor or pharmacist promptly.||
2402|149|S|   To prevent constipation, eat dietary fiber, drink enough||
2402|150|S|water, and exercise. You may also need to take a laxative. Ask||
2402|151|S|your pharmacist which type of laxative is right for you.||
2402|152|S|   To reduce the risk of dizziness and lightheadedness, get up||
2402|153|S|slowly when rising from a sitting or lying position.||
2402|154|S|   Remember that this medication has been prescribed because your||
2402|155|S|doctor has judged that the benefit to you is greater than the||
2402|156|S|risk of side effects. Many people using this medication do not||
2402|157|S|have serious side effects.||
2402|158|S|   This medication may raise your blood pressure. Check your||
2402|159|S|blood pressure regularly and tell your doctor if the results are||
2402|160|S|high.||
2402|161|S|   Tell your doctor right away if you have any serious side||
2402|162|S|effects, including: interrupted breathing during sleep (sleep||
2402|163|S|apnea), mental/mood changes (such as agitation, hallucinations),||
2402|164|S|severe stomach/abdominal pain, signs of your adrenal glands not||
2402|165|S|working well (such as loss of appetite, unusual tiredness, weight||
2402|166|S|loss), pain/swelling/warmth in the groin/calf, signs of kidney||
2402|167|S|problems (such as change in the amount of urine), difficulty||
2402|168|S|urinating, difficult/painful swallowing, symptoms of heart||
2402|169|S|failure (such as swelling ankles/feet, unusual tiredness,||
2402|170|S|unusual/sudden weight gain).||
2402|171|S|   Get medical help right away if you have any very serious side||
2402|172|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2402|173|S|fainting, seizure.||
2402|174|S|   This medication may rarely cause serious (possibly fatal)||
2402|175|S|liver disease. Get medical help right away if you have any||
2402|176|S|symptoms of liver damage, including: nausea/vomiting that doesn't||
2402|177|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
2402|178|S|eyes/skin, dark urine.||
2402|179|S|   This medication may increase serotonin and rarely cause a very||
2402|180|S|serious condition called serotonin syndrome/toxicity. The risk||
2402|181|S|increases if you are also taking other drugs that increase||
2402|182|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2402|183|S|take (see Drug Interactions section). Get medical help right away||
2402|184|S|if you develop some of the following symptoms: fast heartbeat,||
2402|185|S|hallucinations, loss of coordination, severe dizziness, severe||
2402|186|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2402|187|S|unusual agitation/restlessness.||
2402|188|S|   Tramadol is changed into a strong opioid drug in your body. In||
2402|189|S|some people, this change happens faster and more completely than||
2402|190|S|usual, which increases the risk of very serious side effects. Get||
2402|191|S|medical help right away if you notice any of the following:||
2402|192|S|slow/shallow breathing, severe drowsiness/difficulty waking up,||
2402|193|S|confusion.||
2402|194|S|   A very serious allergic reaction to this drug is rare.||
2402|195|S|However, get medical help right away if you notice any symptoms||
2402|196|S|of a serious allergic reaction, including: fever, swollen lymph||
2402|197|S|nodes, rash, itching/swelling (especially of the||
2402|198|S|face/tongue/throat), severe dizziness, trouble breathing.||
2402|199|S|   This is not a complete list of possible side effects. If you||
2402|200|S|notice other effects not listed above, contact your doctor or||
2402|201|S|pharmacist.||
2402|202|S|   In the US -||
2402|203|S|   Call your doctor for medical advice about side effects. You||
2402|204|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2402|205|S|www.fda.gov/medwatch.||
2402|206|S|   In Canada - Call your doctor for medical advice about side||
2402|207|S|effects. You may report side effects to Health Canada at||
2402|208|S|1-866-234-2345.||
2402|209|B|||
2402|210|P|PRECAUTIONS:  See also Warning section.||
2402|211|P|   Before taking tramadol/celecoxib, tell your doctor or||
2402|212|P|pharmacist if you are allergic to it; or to aspirin, other NSAIDs||
2402|213|P|(such as ibuprofen, naproxen); or if you have any other||
2402|214|P|allergies. This product may contain inactive ingredients, which||
2402|215|P|can cause allergic reactions or other problems. Talk to your||
2402|216|P|pharmacist for more details.||
2402|217|P|   Before using this medication, tell your doctor or pharmacist||
2402|218|P|your medical history, especially of: asthma (including a history||
2402|219|P|of worsening breathing after taking aspirin or other NSAIDs),||
2402|220|P|blood disorders (such as anemia, bleeding/clotting problems),||
2402|221|P|brain disorders (such as head injury, tumor, seizures), breathing||
2402|222|P|problems (such as sleep apnea, chronic obstructive pulmonary||
2402|223|P|disease-COPD), diabetes, gallbladder disease, growths in the nose||
2402|224|P|(nasal polyps), heart disease (such as heart failure, previous||
2402|225|P|heart attack), high blood pressure, kidney disease, liver||
2402|226|P|disease, mental/mood disorders (such as confusion, depression,||
2402|227|P|suicidal thoughts), disease of the pancreas (pancreatitis),||
2402|228|P|stroke, thyroid disease, personal or family history of a||
2402|229|P|substance use disorder (such as overuse of or addiction to||
2402|230|P|drugs/alcohol), stomach/intestinal/esophagus problems (such as||
2402|231|P|bleeding, blockage, constipation, ulcers), difficulty urinating||
2402|232|P|(such as due to enlarged prostate).||
2402|233|P|   Kidney problems can sometimes occur with the use of NSAID||
2402|234|P|medications, including celecoxib. Problems are more likely to||
2402|235|P|occur if you are dehydrated, have heart failure or kidney||
2402|236|P|disease, are an older adult, or if you take certain medications||
2402|237|P|(see also Drug Interactions section). Drink plenty of fluids as||
2402|238|P|directed by your doctor to prevent dehydration and tell your||
2402|239|P|doctor right away if you have any unusual change in the amount of||
2402|240|P|urine.||
2402|241|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
2402|242|P|and tobacco, especially when combined with this medicine, may||
2402|243|P|increase your risk for stomach bleeding. Avoid alcohol and stop||
2402|244|P|smoking. Consult your doctor or pharmacist for more information.||
2402|245|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2402|246|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2402|247|P|machinery, or do anything that needs alertness until you can do||
2402|248|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2402|249|P|are using marijuana (cannabis).||
2402|250|P|   This medication may cause a condition that affects the heart||
2402|251|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2402|252|P|serious (rarely fatal) fast/irregular heartbeat and other||
2402|253|P|symptoms (such as severe dizziness, fainting) that need medical||
2402|254|P|attention right away.||
2402|255|P|   The risk of QT prolongation may be increased if you have||
2402|256|P|certain medical conditions or are taking other drugs that may||
2402|257|P|cause QT prolongation. Before using this medication, tell your||
2402|258|P|doctor or pharmacist of all the drugs you take and if you have||
2402|259|P|any of the following conditions: certain heart problems (heart||
2402|260|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2402|261|P|history of certain heart problems (QT prolongation in the EKG,||
2402|262|P|sudden cardiac death).||
2402|263|P|   Low levels of potassium or magnesium in the blood may also||
2402|264|P|increase your risk of QT prolongation. This risk may increase if||
2402|265|P|you use certain drugs (such as diuretics/"water pills") or if you||
2402|266|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2402|267|P|Talk to your doctor about using this medication safely.||
2402|268|P|   Before having surgery, tell your doctor or dentist about all||
2402|269|P|the products you use (including prescription drugs,||
2402|270|P|nonprescription drugs, and herbal products).||
2402|271|P|   Some children may be more sensitive to very serious side||
2402|272|P|effects of this medication, such as extreme sleepiness,||
2402|273|P|confusion, or slow/shallow/noisy breathing. (See also Warning||
2402|274|P|section.)||
2402|275|P|   Older adults may be more sensitive to the side effects of this||
2402|276|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
2402|277|P|breathing, and QT prolongation (see above). Older adults may also||
2402|278|P|be at greater risk for stomach/intestinal bleeding, kidney||
2402|279|P|problems, heart attack, and stroke, and more likely to develop a||
2402|280|P|type of salt imbalance (hyponatremia) while using this drug.||
2402|281|P|   During pregnancy, this medication should be used only when||
2402|282|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2402|283|P|benefits with your doctor. (See also Warning section.)||
2402|284|P|   This medication passes into breast milk and may have||
2402|285|P|undesirable effects on a nursing infant (such as unusual||
2402|286|P|sleepiness, difficulty feeding, or trouble breathing).||
2402|287|P|Breastfeeding is not recommended while using this medication.||
2402|288|P|Consult your doctor before breastfeeding.||
2402|289|B|||
2402|290|I|DRUG INTERACTIONS:  See also Warning section.||
2402|291|I|   Drug interactions may change how your medications work or||
2402|292|I|increase your risk for serious side effects. This document does||
2402|293|I|not contain all possible drug interactions. Keep a list of all||
2402|294|I|the products you use (including prescription/nonprescription||
2402|295|I|drugs and herbal products) and share it with your doctor and||
2402|296|I|pharmacist. Do not start, stop, or change the dosage of any||
2402|297|I|medicines without your doctor's approval.||
2402|298|I|   Some products that may interact with this drug are: ACE||
2402|299|I|inhibitors (such as captopril, lisinopril), aliskiren,||
2402|300|I|angiotensin II receptor blockers (such as valsartan, losartan),||
2402|301|I|cidofovir, corticosteroids (such as dexamethasone, prednisone),||
2402|302|I|lithium, methotrexate, naltrexone, certain pain medications||
2402|303|I|(mixed opioid agonist-antagonists such as butorphanol,||
2402|304|I|nalbuphine, pentazocine), samidorphan, "water pills" (diuretics||
2402|305|I|such as furosemide).||
2402|306|I|   This medication may increase the risk of bleeding when taken||
2402|307|I|with other drugs that also may cause bleeding. Examples include||
2402|308|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2402|309|I|dabigatran/enoxaparin/warfarin, among others.||
2402|310|I|   Check all prescription and nonprescription medicine labels||
2402|311|I|carefully since many medications contain pain relievers/fever||
2402|312|I|reducers (aspirin, NSAIDs such as naproxen, ibuprofen,||
2402|313|I|ketorolac). These drugs are similar to celecoxib and may increase||
2402|314|I|your risk of side effects if taken together. However, if your||
2402|315|I|doctor has told you to take low-dose aspirin to prevent heart||
2402|316|I|attack or stroke (usually 81-162 milligrams a day), you should||
2402|317|I|keep taking the aspirin unless your doctor tells you not to. Ask||
2402|318|I|your doctor or pharmacist for more details.||
2402|319|I|   Taking MAO inhibitors with this medication may cause a serious||
2402|320|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2402|321|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2402|322|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2402|323|I|selegiline, tranylcypromine) during treatment with this||
2402|324|I|medication. Most MAO inhibitors should also not be taken for two||
2402|325|I|weeks before treatment with this medication. Ask your doctor when||
2402|326|I|to start or stop taking this medication.||
2402|327|I|   The risk of serotonin syndrome/toxicity increases if you are||
2402|328|I|also taking other drugs that increase serotonin. Examples include||
2402|329|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
2402|330|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2402|331|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2402|332|I|serotonin syndrome/toxicity may be more likely when you start or||
2402|333|I|increase the dose of these drugs.||
2402|334|I|   Other medications can affect the removal of this medication||
2402|335|I|from your body, which may affect how it works. Examples include||
2402|336|I|azole antifungals (such as itraconazole), macrolide antibiotics||
2402|337|I|(such as erythromycin), quinidine, rifamycins (such as rifampin),||
2402|338|I|ritonavir, drugs used to treat seizures (such as carbamazepine),||
2402|339|I|among others.||
2402|340|I|   The risk of serious side effects (such as slow/shallow||
2402|341|I|breathing, severe drowsiness/dizziness) may be increased if this||
2402|342|I|medication is taken with other products that may also cause||
2402|343|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2402|344|I|if you are taking other products such as other opioid pain or||
2402|345|I|cough relievers (such as codeine, hydrocodone), alcohol,||
2402|346|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
2402|347|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2402|348|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2402|349|I|cetirizine, diphenhydramine).||
2402|350|I|   Check the labels on all your medicines (such as allergy or||
2402|351|I|cough-and-cold products) because they may contain ingredients||
2402|352|I|that cause drowsiness. Ask your pharmacist about using those||
2402|353|I|products safely.||
2402|354|I|   This medication may interfere with certain lab tests||
2402|355|I|(including amylase/lipase levels), possibly causing false test||
2402|356|I|results. Make sure lab personnel and all your doctors know you||
2402|357|I|use this drug.||
2402|358|B|||
2402|359|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2402|360|O|as passing out or trouble breathing, give them naloxone or||
2402|361|O|nalmefene if available, then call 911. If the person is awake and||
2402|362|O|has no symptoms, call a poison control center right away. US||
2402|363|O|residents can call 1-800-222-1222. Canada residents can call||
2402|364|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
2402|365|O|breathing, slow/irregular heartbeat, coma, seizure, severe||
2402|366|O|stomach pain, severe headache, or loss of consciousness.||
2402|367|B|||
2402|368|N|NOTES:  Do not share this medication with others. Sharing it is||
2402|369|N|against the law.||
2402|370|N|   Lab and/or medical tests (such as complete blood count,||
2402|371|N|liver/kidney function, blood pressure) may be done while you are||
2402|372|N|using this medication. Keep all medical and lab appointments.||
2402|373|N|Consult your doctor for more details.||
2402|374|N|   This medication has been prescribed for your current condition||
2402|375|N|only. Do not use it later for another condition unless your||
2402|376|N|doctor tells you to. A different medication may be necessary in||
2402|377|N|that case.||
2402|378|B|||
2402|379|D|MISSED DOSE:  Not applicable.||
2402|380|B|||
2402|381|R|STORAGE:  Store at room temperature away from light and moisture.||
2402|382|R|Do not store in the bathroom. Keep all medications away from||
2402|383|R|children and pets.||
2402|384|R|   Do not flush medications down the toilet or pour them into a||
2402|385|R|drain unless instructed to do so. Properly discard this product||
2402|386|R|when it is expired or no longer needed. Consult your pharmacist||
2402|387|R|or local waste disposal company.||
2402|388|B|||
2402|389|A|Information last revised October 2025.||
2402|390|A|Copyright(c) 2025 First Databank, Inc.||
2402|391|B|||
2403|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2403|002|Z|does NOT have all possible information about this product. This||
2403|003|Z|information does not assure that this product is safe, effective,||
2403|004|Z|or appropriate for you. This information is not individual||
2403|005|Z|medical advice and does not substitute for the advice of your||
2403|006|Z|health care professional. Always ask your health care||
2403|007|Z|professional for complete information about this product and your||
2403|008|Z|specific health needs.||
2403|009|B|||
2403|010|T|COVID-19 VACCINE (NOVAVAX) - INJECTION||
2403|011|B|||
2403|012|C|COMMON BRAND NAME(S): Nuvaxovid||
2403|013|B|||
2403|014|U|USES:  This vaccine is used to help prevent coronavirus disease,||
2403|015|U|also known as COVID-19. It works by increasing the body's natural||
2403|016|U|defense (immunity) against the virus. This vaccine may prevent||
2403|017|U|the illness, or reduce the seriousness of it. The FDA is allowing||
2403|018|U|this vaccine to be given for emergency use in people 12 years old||
2403|019|U|and older. Health Canada has approved this vaccine for use in||
2403|020|U|people 12 years and older.||
2403|021|U|   Vaccines may not fully protect everyone who receives them.||
2403|022|B|||
2403|023|H|HOW TO USE:  Read all vaccine information available from your||
2403|024|H|health care professional before receiving the vaccine. If you||
2403|025|H|have any questions, ask your health care professional.||
2403|026|H|   This vaccine is given by injection into a muscle by a health||
2403|027|H|care professional. It is given in the upper arm. Closely follow||
2403|028|H|the vaccination schedule provided by the health care||
2403|029|H|professional. To help you remember, mark your calendar with a||
2403|030|H|reminder.||
2403|031|B|||
2403|032|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
2403|033|S|tiredness, headache, fever, muscle/joint pain, nausea, or||
2403|034|S|vomiting may occur. If any of these effects last or get worse,||
2403|035|S|tell your health care professional promptly.||
2403|036|S|   Rarely, some people have symptoms such as fainting, dizziness,||
2403|037|S|vision changes, or ringing in the ears just after getting a||
2403|038|S|vaccine injection. Tell your health care professional right away||
2403|039|S|if you have any of these symptoms. Sitting or lying down may||
2403|040|S|help, since these symptoms usually don't last long.||
2403|041|S|   Remember that this vaccine has been prescribed because your||
2403|042|S|health care professional has judged that the benefit to you is||
2403|043|S|greater than the risk of side effects. Many people using this||
2403|044|S|vaccine do not have serious side effects.||
2403|045|S|   There have been rare reports of swelling of the heart muscle||
2403|046|S|(myocarditis) or the lining of the heart (pericarditis) that||
2403|047|S|occurred, usually within 10 days after receiving this vaccine. If||
2403|048|S|you notice any of the following symptoms, get medical help right||
2403|049|S|away: chest pain, shortness of breath, fast/pounding heartbeat.||
2403|050|S|   A very serious allergic reaction to this vaccine is rare. Get||
2403|051|S|medical help right away if you notice any symptoms of a serious||
2403|052|S|allergic reaction, including: rash, itching/swelling (especially||
2403|053|S|of the face/tongue/throat), severe dizziness, trouble breathing.||
2403|054|S|   This is not a complete list of possible side effects. If you||
2403|055|S|notice other effects not listed above, contact your health care||
2403|056|S|professional.||
2403|057|S|   Contact the doctor for medical advice about side effects. The||
2403|058|S|following numbers do not provide medical advice, but in the US||
2403|059|S|you may report side effects to the Vaccine Adverse Event||
2403|060|S|Reporting System (VAERS) at 1-800-822-7967. In Canada, you may||
2403|061|S|call the Vaccine Safety Section at Public Health Agency of Canada||
2403|062|S|at 1-866-844-0018.||
2403|063|B|||
2403|064|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
2403|065|P|care professional if you are allergic to it; or if you have any||
2403|066|P|other allergies. This product may contain inactive ingredients||
2403|067|P|(such as polysorbate), which can cause allergic reactions or||
2403|068|P|other problems. Talk to your pharmacist for more details.||
2403|069|P|   Before receiving this vaccine, tell your health care||
2403|070|P|professional your medical history, especially of: current||
2403|071|P|fever/illness, immune system disorders (such as those due to||
2403|072|P|cancer/radiation treatment), certain heart problems (myocarditis,||
2403|073|P|pericarditis), vaccination history (including previous reactions||
2403|074|P|to any vaccines).||
2403|075|P|   Tell your doctor if you are pregnant before using this||
2403|076|P|vaccine.||
2403|077|P|   It is unknown if this vaccine passes into breast milk. Consult||
2403|078|P|your health care professional before breastfeeding.||
2403|079|B|||
2403|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2403|081|I|medications work or increase your risk for serious side effects.||
2403|082|I|This document does not contain all possible drug interactions.||
2403|083|I|Keep a list of all the products you use (including||
2403|084|I|prescription/nonprescription drugs and herbal products) and share||
2403|085|I|it with your health care professional. Do not start, stop, or||
2403|086|I|change the dosage of any medicines without your doctor's||
2403|087|I|approval.||
2403|088|I|   Some products that may interact with this vaccine are: drugs||
2403|089|I|that weaken the immune system (including cyclosporine,||
2403|090|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
2403|091|I|prednisone).||
2403|092|B|||
2403|093|O|OVERDOSE:  Not applicable.||
2403|094|B|||
2403|095|N|NOTES:  Keep all medical and lab appointments.||
2403|096|N|   Keep vaccine records for yourself and your children and||
2403|097|N|provide them to the health care professionals to prevent||
2403|098|N|unnecessary re-vaccinations.||
2403|099|B|||
2403|100|D|MISSED DOSE:  It is important that you get each vaccination as||
2403|101|D|scheduled. Ask when you should get each dose and mark your||
2403|102|D|calendar with a reminder. If you miss a dose, call the health||
2403|103|D|care professional to reschedule.||
2403|104|B|||
2403|105|R|STORAGE:  Not applicable. This vaccine is given in a hospital or||
2403|106|R|clinic and will not be stored at home.||
2403|107|B|||
2403|108|A|Information last revised February 2025.||
2403|109|A|Copyright(c) 2025 First Databank, Inc.||
2403|110|B|||
2404|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2404|002|Z|does NOT have all possible information about this product. This||
2404|003|Z|information does not assure that this product is safe, effective,||
2404|004|Z|or appropriate for you. This information is not individual||
2404|005|Z|medical advice and does not substitute for the advice of your||
2404|006|Z|health care professional. Always ask your health care||
2404|007|Z|professional for complete information about this product and your||
2404|008|Z|specific health needs.||
2404|009|B|||
2404|010|T|TRETINOIN/BENZOYL PEROXIDE - TOPICAL||
2404|011|F|(TRET-i-noyn/BEN-zoe-il per-OX-ide)||
2404|012|B|||
2404|013|C|COMMON BRAND NAME(S): Twyneo||
2404|014|B|||
2404|015|U|USES:  This combination product is used to treat acne. It may||
2404|016|U|decrease the number and severity of acne pimples and help quick||
2404|017|U|healing of pimples that do develop. Tretinoin belongs to a class||
2404|018|U|of medications called retinoids. It works by affecting the growth||
2404|019|U|of skin cells. Benzoyl peroxide can stop the growth of||
2404|020|U|acne-causing bacteria as well as causing the skin to dry and||
2404|021|U|peel.||
2404|022|B|||
2404|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2404|024|H|from your pharmacist before you start using this product and each||
2404|025|H|time you get a refill. If you have any questions, ask your doctor||
2404|026|H|or pharmacist.||
2404|027|H|   Wash your hands before applying this medication. Gently clean||
2404|028|H|the affected skin with a mild or soapless cleanser and pat dry.||
2404|029|H|Use your fingertips to apply a small amount of medication (about||
2404|030|H|the size of a pea) in a thin layer as directed by your doctor,||
2404|031|H|usually once daily.||
2404|032|H|   Use this medication on the skin only. Do not apply to the lips||
2404|033|H|or inside the nose/mouth. Do not apply to cut, scraped,||
2404|034|H|sunburned, or eczema-affected skin.||
2404|035|H|   Avoid getting this medication in your eyes. If this medication||
2404|036|H|gets into your eyes, flush with large amounts of water. Call your||
2404|037|H|doctor if eye irritation develops. Wash your hands after using||
2404|038|H|the medication to avoid accidentally getting it in your eyes.||
2404|039|H|   Use this medication regularly to get the most benefit from it.||
2404|040|H|To help you remember, use it at the same time each day. Do not||
2404|041|H|apply large amounts of this medication, use it more often, or use||
2404|042|H|it for longer than prescribed. Your condition will not improve||
2404|043|H|any faster, and your risk of side effects will increase.||
2404|044|H|   Benzoyl peroxide may bleach hair or fabrics. Use this product||
2404|045|H|carefully, and avoid contact with hair, clothing, and||
2404|046|H|furnishings.||
2404|047|H|   Tell your doctor if your condition does not get better or if||
2404|048|H|it gets worse||
2404|049|B|||
2404|050|S|SIDE EFFECTS:  Redness, dryness, itching, peeling, or mild||
2404|051|S|burning/pain at the application site may occur. A moisturizer may||
2404|052|S|help reduce these side effects. If any of these effects last or||
2404|053|S|get worse, tell your doctor or pharmacist promptly.||
2404|054|S|   Remember that this medication has been prescribed because your||
2404|055|S|doctor has judged that the benefit to you is greater than the||
2404|056|S|risk of side effects. Many people using this medication do not||
2404|057|S|have serious side effects.||
2404|058|S|   Tell your doctor right away if you have any serious side||
2404|059|S|effects, including: blistering/crusting of the skin, severe||
2404|060|S|burning/swelling of the skin, skin discoloration.||
2404|061|S|   A very serious allergic reaction to this drug is rare.||
2404|062|S|However, get medical help right away if you notice any symptoms||
2404|063|S|of a serious allergic reaction, including: rash, itching/swelling||
2404|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2404|065|S|breathing.||
2404|066|S|   This is not a complete list of possible side effects. If you||
2404|067|S|notice other effects not listed above, contact your doctor or||
2404|068|S|pharmacist.||
2404|069|S|   In the US -||
2404|070|S|   Call your doctor for medical advice about side effects. You||
2404|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2404|072|S|www.fda.gov/medwatch.||
2404|073|S|   In Canada - Call your doctor for medical advice about side||
2404|074|S|effects. You may report side effects to Health Canada at||
2404|075|S|1-866-234-2345.||
2404|076|B|||
2404|077|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2404|078|P|pharmacist if you are allergic to tretinoin or benzoyl peroxide;||
2404|079|P|or if you have any other allergies. This product may contain||
2404|080|P|inactive ingredients, which can cause allergic reactions or other||
2404|081|P|problems. Talk to your pharmacist for more details.||
2404|082|P|   Before using this medication, tell your doctor or pharmacist||
2404|083|P|your medical history, especially of: eczema.||
2404|084|P|   This medication may make you more sensitive to the sun. Limit||
2404|085|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2404|086|P|sunscreen and wear protective clothing when outdoors. Tell your||
2404|087|P|doctor right away if you get sunburned or have skin||
2404|088|P|blisters/redness.||
2404|089|P|   Avoid electrolysis, waxing, and chemical depilatories for hair||
2404|090|P|removal on the treated areas while using this product.||
2404|091|P|   Before having surgery, tell your doctor or dentist about all||
2404|092|P|the products you use (including prescription drugs,||
2404|093|P|nonprescription drugs, and herbal products).||
2404|094|P|   During pregnancy, this medication should be used only when||
2404|095|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2404|096|P|benefits with your doctor.||
2404|097|P|   It is unknown if this drug passes into breast milk. Consult||
2404|098|P|your doctor before breastfeeding.||
2404|099|B|||
2404|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2404|101|I|medications work or increase your risk for serious side effects.||
2404|102|I|This document does not contain all possible drug interactions.||
2404|103|I|Keep a list of all the products you use (including||
2404|104|I|prescription/nonprescription drugs and herbal products) and share||
2404|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
2404|106|I|the dosage of any medicines without your doctor's approval.||
2404|107|I|   A product that may interact with this drug is: dapsone used on||
2404|108|I|the skin.||
2404|109|I|   Avoid using other skin products that are harsh, irritating, or||
2404|110|I|drying on the treated area. These products include hair perming||
2404|111|I|solutions, alcohol/lime/menthol-containing products (such as||
2404|112|I|astringents, toners, shaving lotion), medicated or abrasive soaps||
2404|113|I|or cleansers, soaps and cosmetics with a strong drying effect||
2404|114|I|(such as alpha hydroxy acids, glycolic acid), and products||
2404|115|I|containing sulfur, resorcinol, or salicylic acid.||
2404|116|B|||
2404|117|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2404|118|O|has overdosed and has serious symptoms such as passing out or||
2404|119|O|trouble breathing, call 911. Otherwise, call a poison control||
2404|120|O|center right away. US residents can call 1-800-222-1222. Canada||
2404|121|O|residents can call 1-844-764-7669.||
2404|122|B|||
2404|123|N|NOTES:  Do not share this medication with others.||
2404|124|B|||
2404|125|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2404|126|D|If it is near the time of the next dose, skip the missed dose.||
2404|127|D|Use your next dose at the regular time. Do not double the dose to||
2404|128|D|catch up.||
2404|129|B|||
2404|130|R|STORAGE:  Store at room temperature. Do not freeze. Discard||
2404|131|R|product 12 weeks after receiving from pharmacy or 60 days after||
2404|132|R|opening, whichever is sooner. Keep all medications away from||
2404|133|R|children and pets.||
2404|134|R|   Do not flush medications down the toilet or pour them into a||
2404|135|R|drain unless instructed to do so. Properly discard this product||
2404|136|R|when it is expired or no longer needed. Consult your pharmacist||
2404|137|R|or local waste disposal company.||
2404|138|B|||
2404|139|A|Information last revised July 2025.||
2404|140|A|Copyright(c) 2025 First Databank, Inc.||
2404|141|B|||
2405|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2405|002|Z|does NOT have all possible information about this product. This||
2405|003|Z|information does not assure that this product is safe, effective,||
2405|004|Z|or appropriate for you. This information is not individual||
2405|005|Z|medical advice and does not substitute for the advice of your||
2405|006|Z|health care professional. Always ask your health care||
2405|007|Z|professional for complete information about this product and your||
2405|008|Z|specific health needs.||
2405|009|B|||
2405|010|T|MITAPIVAT - ORAL||
2405|011|F|(MYE-ta-PIV-at)||
2405|012|B|||
2405|013|C|COMMON BRAND NAME(S): Pyrukynd||
2405|014|B|||
2405|015|U|USES:  This medication is used to treat hemolytic anemia. It||
2405|016|U|works by slowing the breakdown of red blood cells. It may help to||
2405|017|U|improve symptoms of anemia (such as shortness of breath,||
2405|018|U|tiredness) and decrease the need for blood transfusion.||
2405|019|B|||
2405|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2405|021|H|from your pharmacist before you start taking mitapivat and each||
2405|022|H|time you get a refill. If you have any questions, ask your doctor||
2405|023|H|or pharmacist.||
2405|024|H|   Take this medication by mouth with or without food as directed||
2405|025|H|by your doctor, usually twice daily. The dosage is based on your||
2405|026|H|medical condition, response to treatment, lab tests, and other||
2405|027|H|medications you may be taking. Be sure to tell your doctor and||
2405|028|H|pharmacist about all the products you use (including prescription||
2405|029|H|drugs, nonprescription drugs, and herbal products).||
2405|030|H|   The manufacturer directs not to split, crush, chew, or||
2405|031|H|dissolve the tablet before taking it. However, many similar drugs||
2405|032|H|(immediate-release tablets) can be split, crushed, or chewed.||
2405|033|H|Follow your doctor's directions on how to take this medication.||
2405|034|H|   Use this medication regularly to get the most benefit from it.||
2405|035|H|To help you remember, take it at the same times each day.||
2405|036|H|   Do not stop taking this medication without consulting your||
2405|037|H|doctor. Some conditions may become worse when this drug is||
2405|038|H|suddenly stopped. Your dose may need to be gradually decreased.||
2405|039|H|When stopping this medication, tell your doctor right away if you||
2405|040|H|have symptoms such as yellowing eyes/skin, dark urine, confusion,||
2405|041|H|tiredness, or shortness of breath.||
2405|042|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2405|043|H|using this medication unless your doctor or pharmacist says you||
2405|044|H|may do so safely. Grapefruit can increase the chance of side||
2405|045|H|effects with this medicine. Ask your doctor or pharmacist for||
2405|046|H|more details.||
2405|047|H|   Tell your doctor if your condition does not get better or if||
2405|048|H|it gets worse.||
2405|049|B|||
2405|050|S|SIDE EFFECTS:  Back/joint pain, flushing, nausea, vomiting, or||
2405|051|S|diarrhea may occur. If any of these effects last or get worse,||
2405|052|S|tell your doctor or pharmacist promptly.||
2405|053|S|   Remember that this medication has been prescribed because your||
2405|054|S|doctor has judged that the benefit to you is greater than the||
2405|055|S|risk of side effects. Many people using this medication do not||
2405|056|S|have serious side effects.||
2405|057|S|   Tell your doctor right away if you have any serious side||
2405|058|S|effects, including: fast/irregular heartbeat, signs of liver||
2405|059|S|disease (such as nausea/vomiting that doesn't stop, loss of||
2405|060|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2405|061|S|urine).||
2405|062|S|   A very serious allergic reaction to this drug is rare.||
2405|063|S|However, get medical help right away if you notice any symptoms||
2405|064|S|of a serious allergic reaction, including: rash, itching/swelling||
2405|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2405|066|S|breathing.||
2405|067|S|   This is not a complete list of possible side effects. If you||
2405|068|S|notice other effects not listed above, contact your doctor or||
2405|069|S|pharmacist.||
2405|070|S|   In the US -||
2405|071|S|   Call your doctor for medical advice about side effects. You||
2405|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2405|073|S|www.fda.gov/medwatch.||
2405|074|S|   In Canada - Call your doctor for medical advice about side||
2405|075|S|effects. You may report side effects to Health Canada at||
2405|076|S|1-866-234-2345.||
2405|077|B|||
2405|078|P|PRECAUTIONS:  Before taking mitapivat, tell your doctor or||
2405|079|P|pharmacist if you are allergic to it; or if you have any other||
2405|080|P|allergies. This product may contain inactive ingredients, which||
2405|081|P|can cause allergic reactions or other problems. Talk to your||
2405|082|P|pharmacist for more details.||
2405|083|P|   Before using this medication, tell your doctor or pharmacist||
2405|084|P|your medical history, especially of: liver disease.||
2405|085|P|   Before having surgery, tell your doctor or dentist about all||
2405|086|P|the products you use (including prescription drugs,||
2405|087|P|nonprescription drugs, and herbal products).||
2405|088|P|   During pregnancy, this medication should be used only when||
2405|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
2405|090|P|   It is unknown if this medication passes into breast milk.||
2405|091|P|Consult your doctor before breastfeeding.||
2405|092|B|||
2405|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2405|094|I|medications work or increase your risk for serious side effects.||
2405|095|I|This document does not contain all possible drug interactions.||
2405|096|I|Keep a list of all the products you use (including||
2405|097|I|prescription/nonprescription drugs and herbal products) and share||
2405|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
2405|099|I|the dosage of any medicines without your doctor's approval.||
2405|100|I|   Other medications can affect the removal of mitapivat from||
2405|101|I|your body, which may affect how mitapivat works. Examples include||
2405|102|I|azole antifungals (such as itraconazole), lonafarnib, rifamycins||
2405|103|I|(such as rifampin), drugs used to treat seizures (such as||
2405|104|I|carbamazepine, phenytoin), among others.||
2405|105|I|   This medication can speed up the removal of other medications||
2405|106|I|from your body, which may affect how they work. Examples of||
2405|107|I|affected drugs include daridorexant, elacestrant, mavacamten,||
2405|108|I|quizartinib, revumenib, among others.||
2405|109|I|   This medication may decrease the effectiveness of hormonal||
2405|110|I|birth control such as pills, patch, or ring. This could cause||
2405|111|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2405|112|I|use reliable backup birth control methods while using this||
2405|113|I|medication. Also tell your doctor if you have any new spotting or||
2405|114|I|breakthrough bleeding, because these may be signs that your birth||
2405|115|I|control is not working well.||
2405|116|B|||
2405|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2405|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2405|119|O|poison control center right away. US residents can call||
2405|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2405|121|B|||
2405|122|N|NOTES:  Do not share this medication with others.||
2405|123|N|   Lab and/or medical tests (such as hormone levels, liver||
2405|124|N|function, uric acid level) may be done before you start taking||
2405|125|N|this medication and while you are taking it. Keep all medical and||
2405|126|N|lab appointments. Consult your doctor for more details.||
2405|127|B|||
2405|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2405|129|D|remember. If it is more than 4 hours after the missed dose, skip||
2405|130|D|the missed dose. Take your next dose at the regular time. Do not||
2405|131|D|double the dose to catch up.||
2405|132|B|||
2405|133|R|STORAGE:  Store at room temperature away from light and moisture.||
2405|134|R|Keep the blister pack in the original carton until ready to use.||
2405|135|R|Do not store in the bathroom. Keep all medications away from||
2405|136|R|children and pets.||
2405|137|R|   Do not flush medications down the toilet or pour them into a||
2405|138|R|drain unless instructed to do so. Properly discard this product||
2405|139|R|when it is expired or no longer needed. Consult your pharmacist||
2405|140|R|or local waste disposal company.||
2405|141|B|||
2405|142|A|Information last revised March 2025.||
2405|143|A|Copyright(c) 2025 First Databank, Inc.||
2405|144|B|||
2406|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2406|002|Z|does NOT have all possible information about this product. This||
2406|003|Z|information does not assure that this product is safe, effective,||
2406|004|Z|or appropriate for you. This information is not individual||
2406|005|Z|medical advice and does not substitute for the advice of your||
2406|006|Z|health care professional. Always ask your health care||
2406|007|Z|professional for complete information about this product and your||
2406|008|Z|specific health needs.||
2406|009|B|||
2406|010|T|CILTACABTAGENE AUTOLEUCEL - INJECTION||
2406|011|B|||
2406|012|C|COMMON BRAND NAME(S): Carvykti||
2406|013|B|||
2406|014|W|WARNING:  This medication may cause serious (even fatal)||
2406|015|W|reactions (cytokine release syndrome-CRS, hemophagocytic||
2406|016|W|lymphohistiocytosis-HLH/macrophage activation syndrome-MAS).||
2406|017|W|Careful monitoring and prompt treatment may decrease your risk.||
2406|018|W|Before treatment with this medication, tell your doctor your||
2406|019|W|medical history, especially of any current/recent infection. Tell||
2406|020|W|your doctor right away if you have any symptoms such as high||
2406|021|W|fever, trouble breathing, chills/shaking chills, severe||
2406|022|W|nausea/vomiting/diarrhea, severe muscle/joint pain, very low||
2406|023|W|blood pressure, dizziness/lightheadedness, or signs of kidney||
2406|024|W|problems (such as change in the amount of urine).||
2406|025|W|   Serious (even fatal) nerve problems can occur after treatment||
2406|026|W|with ciltacabtagene autoleucel. Nerve problems can occur days or||
2406|027|W|weeks after you receive this medication. Tell your doctor right||
2406|028|W|away if you have mental/mood changes (such as confusion, anxiety,||
2406|029|W|memory loss), drowsiness, seizure, tremor, loss of coordination,||
2406|030|W|numbness/tingling/pain of the hands or feet, leg or arm weakness,||
2406|031|W|facial numbness, difficulty moving the muscles of the face or||
2406|032|W|eyes, or trouble with reading, writing, speaking, or||
2406|033|W|understanding.||
2406|034|W|   Serious (possibly fatal) stomach or intestinal problems,||
2406|035|W|including a serious tear in the stomach or intestinal wall, may||
2406|036|W|occur after treatment with this product. Tell your doctor right||
2406|037|W|away if you have diarrhea that doesn't stop, severe||
2406|038|W|stomach/abdominal pain that doesn't go away, severe||
2406|039|W|nausea/vomiting, weight loss, or fainting.||
2406|040|W|   This product may cause a severe decrease in your blood cells,||
2406|041|W|which lowers your ability to fight infections and increases the||
2406|042|W|risk of anemia/bleeding problems. You may be more likely to get a||
2406|043|W|serious (rarely fatal) infection and any infection you have may||
2406|044|W|get worse. This medication may also cause certain cancers of the||
2406|045|W|bone marrow/blood cells (myelodysplastic syndrome- MDS, acute||
2406|046|W|myeloid leukemia - AML). Tell your doctor right away if you have||
2406|047|W|signs of infection (such as sore throat that doesn't go away,||
2406|048|W|fever, chills, cough), easy or unusual bruising/bleeding, pale||
2406|049|W|skin, or unusual tiredness.||
2406|050|B|||
2406|051|U|USES:  Ciltacabtagene autoleucel is used to treat a certain type||
2406|052|U|of cancer (multiple myeloma) that has not gotten better or that||
2406|053|U|has come back after other kinds of treatment. This type of||
2406|054|U|treatment is known as gene therapy. Ciltacabtagene autoleucel is||
2406|055|U|made from your own white blood cells and is given only to you.||
2406|056|U|The white blood cells have been changed to have a specific||
2406|057|U|protein (chimeric antigen receptor-CAR) that helps your body slow||
2406|058|U|or stop the growth of certain cancer cells.||
2406|059|B|||
2406|060|H|HOW TO USE:  Read the Medication Guide provided by your health||
2406|061|H|care professional before you start using this product. If you||
2406|062|H|have any questions, ask your health care professionals.||
2406|063|H|   Your doctor will give you 3 days of chemotherapy before||
2406|064|H|treatment with this product to prepare your body.||
2406|065|H|   This product is given by slow injection into a vein as||
2406|066|H|directed by your doctor. The injection is given over about 30 to||
2406|067|H|60 minutes. To decrease the risk of side effects, your doctor may||
2406|068|H|also give you other medications (such as acetaminophen,||
2406|069|H|diphenhydramine) before injecting ciltacabtagene autoleucel.||
2406|070|H|   Your doctor will check you daily for at least 7 days after||
2406|071|H|your treatment to see how well it works and help you manage any||
2406|072|H|side effects. You should plan to stay for at least 2 weeks near||
2406|073|H|the place of your treatment (for example, within 2 hours' drive).||
2406|074|B|||
2406|075|S|SIDE EFFECTS:  See also Warning section.||
2406|076|S|   Nausea, vomiting, diarrhea or constipation, headache,||
2406|077|S|tiredness, trouble sleeping, or loss of appetite may occur. If||
2406|078|S|any of these effects last or get worse, tell your doctor or||
2406|079|S|pharmacist promptly.||
2406|080|S|   People using this medication may have serious side effects.||
2406|081|S|However, you have been prescribed this drug because your doctor||
2406|082|S|has judged that the benefit to you is greater than the risk of||
2406|083|S|side effects. Careful monitoring by your doctor may decrease your||
2406|084|S|risk.||
2406|085|S|   Tell your doctor right away if you have any serious side||
2406|086|S|effects, including: fast/irregular heartbeat, muscle/joint pain,||
2406|087|S|swelling.||
2406|088|S|   A very serious allergic reaction to this drug is rare.||
2406|089|S|However, get medical help right away if you notice any symptoms||
2406|090|S|of a serious allergic reaction, including: rash, itching/swelling||
2406|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2406|092|S|breathing.||
2406|093|S|   This is not a complete list of possible side effects. If you||
2406|094|S|notice other effects not listed above, contact your doctor or||
2406|095|S|pharmacist.||
2406|096|S|   In the US -||
2406|097|S|   Call your doctor for medical advice about side effects. You||
2406|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2406|099|S|www.fda.gov/medwatch.||
2406|100|S|   In Canada - Call your doctor for medical advice about side||
2406|101|S|effects. You may report side effects to Health Canada at||
2406|102|S|1-866-234-2345.||
2406|103|B|||
2406|104|P|PRECAUTIONS:  Before receiving ciltacabtagene autoleucel, tell||
2406|105|P|your doctor or pharmacist if you have any allergies. This product||
2406|106|P|may contain inactive ingredients, which can cause allergic||
2406|107|P|reactions or other problems. Talk to your pharmacist for more||
2406|108|P|details.||
2406|109|P|   Before using this medication, tell your doctor or pharmacist||
2406|110|P|your medical history, especially of: heart problems, kidney||
2406|111|P|problems, liver problems, lung or breathing problems, nerve||
2406|112|P|problems (such as memory loss, numbness/tingling, seizures),||
2406|113|P|past/current/recent infection.||
2406|114|P|   This product can make you more likely to get infections or may||
2406|115|P|make current infections worse. Stay away from anyone who has an||
2406|116|P|infection that may easily spread (such as chickenpox, COVID-19,||
2406|117|P|measles, flu). Talk to your doctor if you have been exposed to an||
2406|118|P|infection or for more details.||
2406|119|P|   Tell your health care professional that you are using||
2406|120|P|ciltacabtagene autoleucel before having any||
2406|121|P|immunizations/vaccinations. Avoid contact with people who have||
2406|122|P|recently received live vaccines (such as flu vaccine inhaled||
2406|123|P|through the nose).||
2406|124|P|   To lower the chance of getting cut, bruised, or injured, use||
2406|125|P|caution with sharp objects like razors and nail cutters, and||
2406|126|P|avoid activities such as contact sports.||
2406|127|P|   This drug may make you drowsy or dizzy, affect your||
2406|128|P|coordination, or make it harder for you to think clearly. Alcohol||
2406|129|P|or marijuana (cannabis) can worsen these effects. Do not drive,||
2406|130|P|use machinery, or do anything that needs alertness until you can||
2406|131|P|do it safely (at least 2 weeks after receiving treatment is||
2406|132|P|recommended by the manufacturer). Limit alcoholic beverages. Talk||
2406|133|P|to your doctor if you are using marijuana (cannabis).||
2406|134|P|   Before having surgery, tell your doctor or dentist about all||
2406|135|P|the products you use (including prescription drugs,||
2406|136|P|nonprescription drugs, and herbal products).||
2406|137|P|   Tell your doctor if you are pregnant or plan to become||
2406|138|P|pregnant. You should not become pregnant while using this||
2406|139|P|product. Ciltacabtagene autoleucel may harm an unborn baby. Your||
2406|140|P|doctor should order a pregnancy test before you start this||
2406|141|P|medication. Ask about reliable forms of birth control while using||
2406|142|P|this medication. If you become pregnant, talk to your doctor||
2406|143|P|right away about the risks and benefits of this medication.||
2406|144|P|   It is unknown if this product passes into breast milk. Consult||
2406|145|P|your doctor before breastfeeding.||
2406|146|B|||
2406|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2406|148|I|medications work or increase your risk for serious side effects.||
2406|149|I|This document does not contain all possible drug interactions.||
2406|150|I|Keep a list of all the products you use (including||
2406|151|I|prescription/nonprescription drugs and herbal products) and share||
2406|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
2406|153|I|the dosage of any medicines without your doctor's approval.||
2406|154|I|   This medication may interfere with certain lab tests (such as||
2406|155|I|some HIV tests), possibly causing false test results. Make sure||
2406|156|I|lab personnel and all your doctors know you use this drug.||
2406|157|B|||
2406|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2406|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2406|160|O|poison control center right away. US residents can call||
2406|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2406|162|B|||
2406|163|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2406|164|N|immunoglobulin levels) should be done before and after you||
2406|165|N|receive this product. Keep all medical and lab appointments.||
2406|166|N|   After receiving this treatment, do not donate blood, organs,||
2406|167|N|tissues, or cells.||
2406|168|B|||
2406|169|D|MISSED DOSE:  Not applicable.||
2406|170|B|||
2406|171|R|STORAGE:  Not applicable. This product is given in a hospital or||
2406|172|R|clinic and will not be stored at home.||
2406|173|B|||
2406|174|M|MEDICAL ALERT:  Your condition can cause complications in a||
2406|175|M|medical emergency. For information about enrolling in MedicAlert,||
2406|176|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2406|177|B|||
2406|178|A|Information last revised October 2025.||
2406|179|A|Copyright(c) 2025 First Databank, Inc.||
2406|180|B|||
2407|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2407|002|Z|does NOT have all possible information about this product. This||
2407|003|Z|information does not assure that this product is safe, effective,||
2407|004|Z|or appropriate for you. This information is not individual||
2407|005|Z|medical advice and does not substitute for the advice of your||
2407|006|Z|health care professional. Always ask your health care||
2407|007|Z|professional for complete information about this product and your||
2407|008|Z|specific health needs.||
2407|009|B|||
2407|010|T|PACRITINIB - ORAL||
2407|011|F|(pak-RI-ti-nib)||
2407|012|B|||
2407|013|C|COMMON BRAND NAME(S): Vonjo||
2407|014|B|||
2407|015|U|USES:  This medication is used to treat a certain bone marrow||
2407|016|U|disorder (myelofibrosis). It works by blocking your body from||
2407|017|U|producing substances called growth factors. Pacritinib belongs to||
2407|018|U|a class of drugs known as kinase inhibitors.||
2407|019|B|||
2407|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2407|021|H|from your pharmacist before you start taking pacritinib and each||
2407|022|H|time you get a refill. If you have any questions, ask your doctor||
2407|023|H|or pharmacist.||
2407|024|H|   Take this medication by mouth with or without food as directed||
2407|025|H|by your doctor, usually twice daily. Swallow the capsules whole.||
2407|026|H|Do not open, break, or chew the capsules.||
2407|027|H|   The dosage is based on your medical condition, lab tests, and||
2407|028|H|response to treatment.||
2407|029|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2407|030|H|using this medication unless your doctor or pharmacist says you||
2407|031|H|may do so safely. Grapefruit can increase the chance of side||
2407|032|H|effects with this medicine. Ask your doctor or pharmacist for||
2407|033|H|more details.||
2407|034|H|   Use this medication regularly to get the most benefit from it.||
2407|035|H|To help you remember, take it at the same times each day.||
2407|036|H|   Do not increase your dose or use this drug more often or for||
2407|037|H|longer than prescribed. Your condition will not improve any||
2407|038|H|faster, and your risk of side effects will increase.||
2407|039|H|   Tell your doctor if your symptoms do not get better or if they||
2407|040|H|get worse.||
2407|041|B|||
2407|042|S|SIDE EFFECTS:  Dizziness, nausea, vomiting, or nosebleeds may||
2407|043|S|occur. If any of these effects last or get worse, tell your||
2407|044|S|doctor or pharmacist promptly.||
2407|045|S|   Diarrhea commonly occurs and can be severe. Your doctor should||
2407|046|S|prescribe medication to help treat diarrhea. This medication||
2407|047|S|should be taken as directed by your doctor, usually at the first||
2407|048|S|sign of diarrhea. Diarrhea that doesn't stop may result in||
2407|049|S|dehydration. Drink plenty of fluids to help prevent dehydration.||
2407|050|S|Tell your doctor right away if you have severe diarrhea or if you||
2407|051|S|notice any symptoms of dehydration, such as unusual decreased||
2407|052|S|urination, unusual dry mouth/thirst, or||
2407|053|S|dizziness/lightheadedness.||
2407|054|S|   People using this medication may have serious side effects.||
2407|055|S|However, you have been prescribed this drug because your doctor||
2407|056|S|has judged that the benefit to you is greater than the risk of||
2407|057|S|side effects. Careful monitoring by your doctor may decrease your||
2407|058|S|risk.||
2407|059|S|   Tell your doctor right away if you have any serious side||
2407|060|S|effects, including: unusual tiredness, easy bleeding/bruising,||
2407|061|S|swelling hands/ankles/feet.||
2407|062|S|   This medication may lower your ability to fight infections.||
2407|063|S|This may make you more likely to get a serious (rarely fatal)||
2407|064|S|infection or make any infection you have worse. Tell your doctor||
2407|065|S|right away if you have any signs of infection (such as sore||
2407|066|S|throat that doesn't go away, fever, chills, painful skin||
2407|067|S|rash/blisters).||
2407|068|S|   Another medication similar to pacritinib has caused serious||
2407|069|S|(possibly fatal) side effects, including heart problems, blood||
2407|070|S|clots, and cancer (such as lymphoma). Before using pacritinib,||
2407|071|S|tell your doctor or pharmacist if you have a history of heart||
2407|072|S|disease, stroke, cancer, or any risk factors for heart disease||
2407|073|S|(such as high blood pressure, diabetes, previous blood clots,||
2407|074|S|high cholesterol, smoking or history of smoking). Discuss the||
2407|075|S|risks and benefits of treatment with your doctor. Get medical||
2407|076|S|help right away if you have symptoms such as shortness of||
2407|077|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
2407|078|S|sweating, sudden dizziness/fainting, pain/swelling/warmth in the||
2407|079|S|groin/calf, sudden/severe headaches, trouble speaking, or||
2407|080|S|weakness on one side of the body.||
2407|081|S|   Get medical help right away if you have any very serious side||
2407|082|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2407|083|S|fainting.||
2407|084|S|   A very serious allergic reaction to this drug is rare.||
2407|085|S|However, get medical help right away if you notice any symptoms||
2407|086|S|of a serious allergic reaction, including: rash, itching/swelling||
2407|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2407|088|S|breathing.||
2407|089|S|   This is not a complete list of possible side effects. If you||
2407|090|S|notice other effects not listed above, contact your doctor or||
2407|091|S|pharmacist.||
2407|092|S|   In the US -||
2407|093|S|   Call your doctor for medical advice about side effects. You||
2407|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2407|095|S|www.fda.gov/medwatch.||
2407|096|S|   In Canada - Call your doctor for medical advice about side||
2407|097|S|effects. You may report side effects to Health Canada at||
2407|098|S|1-866-234-2345.||
2407|099|B|||
2407|100|P|PRECAUTIONS:  See also Side Effects section.||
2407|101|P|   Before taking pacritinib, tell your doctor or pharmacist if||
2407|102|P|you are allergic to it; or if you have any other allergies. This||
2407|103|P|product may contain inactive ingredients, which can cause||
2407|104|P|allergic reactions or other problems. Talk to your pharmacist for||
2407|105|P|more details.||
2407|106|P|   Before using this medication, tell your doctor or pharmacist||
2407|107|P|your medical history, especially of: active bleeding,||
2407|108|P|current/past/returning infections (such as tuberculosis), kidney||
2407|109|P|disease, liver disease.||
2407|110|P|   Pacritinib may cause a condition that affects the heart rhythm||
2407|111|P|(QT prolongation). QT prolongation can rarely cause serious||
2407|112|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2407|113|P|as severe dizziness, fainting) that need medical attention right||
2407|114|P|away.||
2407|115|P|   The risk of QT prolongation may be increased if you have||
2407|116|P|certain medical conditions or are taking other drugs that may||
2407|117|P|cause QT prolongation. Before using pacritinib, tell your doctor||
2407|118|P|or pharmacist of all the drugs you take and if you have any of||
2407|119|P|the following conditions: certain heart problems (heart failure,||
2407|120|P|slow heartbeat, QT prolongation in the EKG), family history of||
2407|121|P|certain heart problems (QT prolongation in the EKG, sudden||
2407|122|P|cardiac death).||
2407|123|P|   Low levels of potassium or magnesium in the blood may also||
2407|124|P|increase your risk of QT prolongation. This risk may increase if||
2407|125|P|you use certain drugs (such as diuretics/"water pills") or if you||
2407|126|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2407|127|P|Talk to your doctor about using pacritinib safely.||
2407|128|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2407|129|P|can make you more dizzy. Do not drive, use machinery, or do||
2407|130|P|anything that needs alertness until you can do it safely. Limit||
2407|131|P|alcoholic beverages. Talk to your doctor if you are using||
2407|132|P|marijuana (cannabis).||
2407|133|P|   Pacritinib can make you more likely to get infections or may||
2407|134|P|make current infections worse. Stay away from anyone who has an||
2407|135|P|infection that may easily spread (such as chickenpox, COVID-19,||
2407|136|P|measles, flu, tuberculosis). Talk to your doctor if you have been||
2407|137|P|exposed to an infection or for more details.||
2407|138|P|   Tell your health care professional that you are using||
2407|139|P|pacritinib before having any immunizations/vaccinations. Avoid||
2407|140|P|contact with people who have recently received live vaccines||
2407|141|P|(such as flu vaccine inhaled through the nose).||
2407|142|P|   To lower the chance of getting cut, bruised, or injured, use||
2407|143|P|caution with sharp objects like razors and nail cutters, and||
2407|144|P|avoid activities such as contact sports.||
2407|145|P|   Before having surgery or a dental procedure, tell your doctor||
2407|146|P|or dentist about all the products you use (including prescription||
2407|147|P|drugs, nonprescription drugs, and herbal products). Your doctor||
2407|148|P|may tell you to stop this medication temporarily for 7 days||
2407|149|P|before surgery. Follow your doctor's directions carefully.||
2407|150|P|   Older adults may be more sensitive to the side effects of this||
2407|151|P|drug, especially QT prolongation (see above).||
2407|152|P|   During pregnancy, this medication should be used only when||
2407|153|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2407|154|P|benefits with your doctor.||
2407|155|P|   It is unknown if this medication passes into breast milk.||
2407|156|P|Because of the possible risk to the infant, breastfeeding is not||
2407|157|P|recommended while using this medication and for 2 weeks after the||
2407|158|P|last dose. Consult your doctor before breastfeeding.||
2407|159|B|||
2407|160|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2407|161|I|medications work or increase your risk for serious side effects.||
2407|162|I|This document does not contain all possible drug interactions.||
2407|163|I|Keep a list of all the products you use (including||
2407|164|I|prescription/nonprescription drugs and herbal products) and share||
2407|165|I|it with your doctor and pharmacist. Do not start, stop, or change||
2407|166|I|the dosage of any medicines without your doctor's approval.||
2407|167|I|   This medication can speed up or slow down the removal of other||
2407|168|I|medications from your body, which may affect how they work.||
2407|169|I|Examples of affected drugs include fezolinetant, lonafarnib,||
2407|170|I|mavacamten, among others.||
2407|171|I|   Other medications can affect the removal of pacritinib from||
2407|172|I|your body, which may affect how pacritinib works. Examples||
2407|173|I|include azole antifungals (such as itraconazole, ketoconazole),||
2407|174|I|cobicistat, lumacaftor, mitotane, rifamycins (such as rifabutin,||
2407|175|I|rifampin), St. John's wort, drugs used to treat seizures (such as||
2407|176|I|carbamazepine, phenobarbital, phenytoin), among others.||
2407|177|I|   Many drugs besides pacritinib may affect the heart rhythm (QT||
2407|178|I|prolongation), including ceritinib, clarithromycin, ivosidenib,||
2407|179|I|levoketoconazole, lopinavir/ritonavir, posaconazole, ribociclib,||
2407|180|I|voriconazole, among others.||
2407|181|I|   This medication may decrease the effectiveness of hormonal||
2407|182|I|birth control such as pills, patch, or ring. This could cause||
2407|183|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2407|184|I|use reliable backup birth control methods while using this||
2407|185|I|medication and for 30 days after the last dose. Also tell your||
2407|186|I|doctor if you have any new spotting or breakthrough bleeding,||
2407|187|I|because these may be signs that your birth control is not working||
2407|188|I|well.||
2407|189|B|||
2407|190|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2407|191|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2407|192|O|poison control center right away. US residents can call||
2407|193|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2407|194|O|Symptoms of overdose may include: blurred vision, severe||
2407|195|O|dizziness.||
2407|196|B|||
2407|197|N|NOTES:  Do not share this medication with others.||
2407|198|N|   Lab and/or medical tests (such as complete blood counts,||
2407|199|N|clotting times, EKG) should be done before you start taking this||
2407|200|N|medication and while you are taking it. Keep all medical and lab||
2407|201|N|appointments. Consult your doctor for more details.||
2407|202|B|||
2407|203|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2407|204|D|next dose at the regular time. Do not double the dose to catch||
2407|205|D|up.||
2407|206|B|||
2407|207|R|STORAGE:  Store in the original container at room temperature||
2407|208|R|away from light and moisture. Do not store in the bathroom.||
2407|209|R|Tightly close the bottle when not in use. Keep all medications||
2407|210|R|away from children and pets.||
2407|211|R|   Do not flush medications down the toilet or pour them into a||
2407|212|R|drain unless instructed to do so. Properly discard this product||
2407|213|R|when it is expired or no longer needed. Consult your pharmacist||
2407|214|R|or local waste disposal company.||
2407|215|B|||
2407|216|A|Information last revised August 2025.||
2407|217|A|Copyright(c) 2025 First Databank, Inc.||
2407|218|B|||
2408|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2408|002|Z|does NOT have all possible information about this product. This||
2408|003|Z|information does not assure that this product is safe, effective,||
2408|004|Z|or appropriate for you. This information is not individual||
2408|005|Z|medical advice and does not substitute for the advice of your||
2408|006|Z|health care professional. Always ask your health care||
2408|007|Z|professional for complete information about this product and your||
2408|008|Z|specific health needs.||
2408|009|B|||
2408|010|T|SOMATROGON - SUBCUTANEOUS INJECTION||
2408|011|F|(soe-MA-troe-gon)||
2408|012|B|||
2408|013|C|COMMON BRAND NAME(S): Ngenla||
2408|014|B|||
2408|015|U|USES:  This medication is used to treat growth failure due to a||
2408|016|U|lack of growth hormone. Growth hormone is normally produced in||
2408|017|U|the brain by a certain gland (pituitary gland) and has various||
2408|018|U|effects on development in the body. A lack of growth hormone in||
2408|019|U|children results in slowed growth and short height for the||
2408|020|U|child's age. Somatrogon works by providing more growth hormone,||
2408|021|U|which may help the long bones (such as the arms and legs) grow||
2408|022|U|longer.||
2408|023|B|||
2408|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
2408|025|H|Instructions for Use if available from your pharmacist before you||
2408|026|H|start using somatrogon and each time you get a refill. Ask your||
2408|027|H|health care professional how to prepare and use this medication.||
2408|028|H|If you have any questions, ask your doctor or pharmacist.||
2408|029|H|   Inject this medication under the skin as directed by your||
2408|030|H|doctor, usually once weekly. The injection is given in the||
2408|031|H|thighs, buttocks, upper arms, or abdomen (except for a 2-inch||
2408|032|H|area around your belly button). The dosage is based on your||
2408|033|H|medical condition, weight, and response to treatment.||
2408|034|H|   For a more comfortable injection, take the medication out of||
2408|035|H|the refrigerator for up to 30 minutes before you inject it to||
2408|036|H|allow it to reach room temperature. Do not warm up this||
2408|037|H|medication any other way (for example, do not heat it in the||
2408|038|H|microwave or place it in hot water). Do not leave the device out||
2408|039|H|of the refrigerator for longer than 2 hours. If there is||
2408|040|H|medication remaining in the device after use, be sure to put it||
2408|041|H|back in the refrigerator. Do not shake the medication.||
2408|042|H|   Before using, check this product for particles or||
2408|043|H|discoloration. If either is present, do not use the liquid.||
2408|044|H|Before injecting each dose, clean the skin you are going to||
2408|045|H|inject into (the injection site) with rubbing alcohol. Change the||
2408|046|H|injection site each time to lessen injury under the skin. Do not||
2408|047|H|inject into skin that is bruised, red, sore, or hard, or into||
2408|048|H|bony areas, scars, or other skin conditions. To lessen bruising,||
2408|049|H|do not rub the injection site after a shot. Learn how to store||
2408|050|H|and discard medical supplies safely.||
2408|051|H|   This medication is injected with a device (prefilled pen) made||
2408|052|H|to help you use it properly. Do not share your device with||
2408|053|H|another person, even if the needle is changed. You may give other||
2408|054|H|people a serious infection, or get a serious infection from them.||
2408|055|H|   Use this medication regularly to get the most benefit from it.||
2408|056|H|To help you remember, mark your calendar with a reminder.||
2408|057|B|||
2408|058|S|SIDE EFFECTS:  Pain, redness, itching, swelling, or thickening of||
2408|059|S|the skin at the injection site may occur. Headache, fever,||
2408|060|S|nausea, vomiting, joint/muscle pain, or cold-like symptoms (such||
2408|061|S|as cough, runny/stuffy nose, sore throat) may also occur. If any||
2408|062|S|of these effects last or get worse, tell your doctor or||
2408|063|S|pharmacist promptly.||
2408|064|S|   Remember that this medication has been prescribed because your||
2408|065|S|doctor has judged that the benefit to you is greater than the||
2408|066|S|risk of side effects. Many people using this medication do not||
2408|067|S|have serious side effects.||
2408|068|S|   Tell your doctor right away if you have any serious side||
2408|069|S|effects, including: development of a limp, hip/knee pain,||
2408|070|S|increased thirst/frequent urination, severe stomach/abdominal||
2408|071|S|pain, swelling hands/ankles/feet, numbness/tingling of arms/legs,||
2408|072|S|symptoms of thyroid problems (such as cold intolerance,||
2408|073|S|unexplained increased weight).||
2408|074|S|   Somatrogon may increase your risk of getting a new tumor or||
2408|075|S|cancer. Children who have had brain/head radiation treatment for||
2408|076|S|cancer should be monitored for new tumors/cancers. Tell your||
2408|077|S|doctor right away if you or a caregiver notice symptoms such as||
2408|078|S|unusual changes in behavior, vision problems/changes, severe||
2408|079|S|headache, changes in skin color, or change in the appearance or||
2408|080|S|size of a mole. Talk with your doctor for details and to discuss||
2408|081|S|the risks and benefits of this medication.||
2408|082|S|   A very serious allergic reaction to this drug is rare.||
2408|083|S|However, get medical help right away if you notice any symptoms||
2408|084|S|of a serious allergic reaction, including: rash, itching/swelling||
2408|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2408|086|S|breathing.||
2408|087|S|   This is not a complete list of possible side effects. If you||
2408|088|S|notice other effects not listed above, contact your doctor or||
2408|089|S|pharmacist.||
2408|090|S|   In the US -||
2408|091|S|   Call your doctor for medical advice about side effects. You||
2408|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2408|093|S|www.fda.gov/medwatch.||
2408|094|S|   In Canada - Call your doctor for medical advice about side||
2408|095|S|effects. You may report side effects to Health Canada at||
2408|096|S|1-866-234-2345.||
2408|097|B|||
2408|098|P|PRECAUTIONS:  See also Side Effects section.||
2408|099|P|   Before using somatrogon, tell your doctor or pharmacist if you||
2408|100|P|are allergic to it; or if you have any other allergies. This||
2408|101|P|product may contain inactive ingredients, which can cause||
2408|102|P|allergic reactions or other problems. Talk to your pharmacist for||
2408|103|P|more details.||
2408|104|P|   Before using this medication, tell your doctor or pharmacist||
2408|105|P|your medical history, especially of: adrenal gland problems,||
2408|106|P|recent major surgery/injury, diabetes, a certain eye condition||
2408|107|P|(diabetic retinopathy), kidney disease, cancer (especially of the||
2408|108|P|head/neck), thyroid problems, a certain back problem (scoliosis),||
2408|109|P|a certain genetic condition (Prader-Willi syndrome).||
2408|110|P|   If you have diabetes, this drug may increase your blood sugar.||
2408|111|P|Check your blood sugar regularly as directed and share the||
2408|112|P|results with your doctor. Tell your doctor right away if you have||
2408|113|P|symptoms of high blood sugar such as increased thirst/urination.||
2408|114|P|Your doctor may need to adjust your diabetes medication, exercise||
2408|115|P|program, or diet.||
2408|116|P|   Before having surgery, tell your doctor or dentist about all||
2408|117|P|the products you use (including prescription drugs,||
2408|118|P|nonprescription drugs, and herbal products).||
2408|119|P|   During pregnancy, this medication should be used only when||
2408|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
2408|121|P|   It is unknown if this drug passes into breast milk. Consult||
2408|122|P|your doctor before breastfeeding.||
2408|123|B|||
2408|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2408|125|I|medications work or increase your risk for serious side effects.||
2408|126|I|This document does not contain all possible drug interactions.||
2408|127|I|Keep a list of all the products you use (including||
2408|128|I|prescription/nonprescription drugs and herbal products) and share||
2408|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
2408|130|I|the dosage of any medicines without your doctor's approval.||
2408|131|I|   This medication may interfere with certain lab tests (such as||
2408|132|I|pregnancy tests), possibly causing false test results. Make sure||
2408|133|I|lab personnel and all your doctors know you use this drug.||
2408|134|B|||
2408|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2408|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2408|137|O|poison control center right away. US residents can call||
2408|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2408|139|B|||
2408|140|N|NOTES:  Do not share this medication with others.||
2408|141|N|   Lab and/or medical tests (such as growth factor blood tests,||
2408|142|N|thyroid function, blood sugar, cortisol level, eye exam) may be||
2408|143|N|done while you are using this medication. Keep all medical and||
2408|144|N|lab appointments.||
2408|145|B|||
2408|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2408|147|D|If it is more than 3 days after the missed dose, skip the missed||
2408|148|D|dose. Use your next dose on the regular scheduled day. Do not||
2408|149|D|double the dose to catch up. If you decide to change the regular||
2408|150|D|scheduled day, make sure to wait at least 3 days between the last||
2408|151|D|dose and the new dosing day.||
2408|152|B|||
2408|153|R|STORAGE:  Store the pen device in the refrigerator away from||
2408|154|R|light. After first use, write the date on the pen label and use||
2408|155|R|the medication within 28 days. Discard the pen after 28 days,||
2408|156|R|even if it contains unused medication. Keep all medications away||
2408|157|R|from children and pets.||
2408|158|R|   Do not flush medications down the toilet or pour them into a||
2408|159|R|drain unless instructed to do so. Properly discard this product||
2408|160|R|when it is expired or no longer needed. Consult your pharmacist||
2408|161|R|or local waste disposal company.||
2408|162|B|||
2408|163|A|Information last revised April 2025.||
2408|164|A|Copyright(c) 2025 First Databank, Inc.||
2408|165|B|||
2409|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2409|002|Z|does NOT have all possible information about this product. This||
2409|003|Z|information does not assure that this product is safe, effective,||
2409|004|Z|or appropriate for you. This information is not individual||
2409|005|Z|medical advice and does not substitute for the advice of your||
2409|006|Z|health care professional. Always ask your health care||
2409|007|Z|professional for complete information about this product and your||
2409|008|Z|specific health needs.||
2409|009|B|||
2409|010|T|NIVOLUMAB/RELATLIMAB - INJECTION||
2409|011|F|(nye-VOL-ue-mab/rel-AT-li-mab)||
2409|012|B|||
2409|013|C|COMMON BRAND NAME(S): Opdualag||
2409|014|B|||
2409|015|U|USES:  This product contains 2 medications: nivolumab and||
2409|016|U|relatlimab. Nivolumab/relatlimab is used to treat a certain type||
2409|017|U|of skin cancer (melanoma). It works by changing the action of||
2409|018|U|your own immune system, directing it to attack cancer cells.||
2409|019|U|Nivolumab and relatlimab belong to a class of drugs known as||
2409|020|U|monoclonal antibodies.||
2409|021|B|||
2409|022|H|HOW TO USE:  Read the Medication Guide provided by your||
2409|023|H|pharmacist before you start receiving nivolumab/relatlimab and||
2409|024|H|each time you get a treatment. If you have any questions, ask||
2409|025|H|your doctor or pharmacist.||
2409|026|H|   This medication is given by injection into a vein by a health||
2409|027|H|care professional over at least 30 minutes. It is given as||
2409|028|H|directed by your doctor, usually once every 4 weeks.||
2409|029|H|   Infusion reactions may happen during the infusion of this||
2409|030|H|drug. Tell your doctor right away if you have symptoms of||
2409|031|H|infusion reactions such as fever, chills, flushing, dizziness, or||
2409|032|H|fainting.||
2409|033|H|   The dosage is based on your medical condition, weight, and||
2409|034|H|response to treatment. Your doctor may stop your treatment for||
2409|035|H|some time if you get serious side effects. Your doctor may also||
2409|036|H|prescribe another medication (a corticosteroid such as||
2409|037|H|prednisone) to help treat side effects of this medication.||
2409|038|B|||
2409|039|S|SIDE EFFECTS:  See also How to Use section.||
2409|040|S|   Nausea, diarrhea, loss of appetite, headache, bone/muscle||
2409|041|S|pain, or tiredness may occur. If any of these effects last or get||
2409|042|S|worse, tell your doctor or pharmacist promptly.||
2409|043|S|   People using this medication may have serious side effects.||
2409|044|S|However, you have been prescribed this drug because your doctor||
2409|045|S|has judged that the benefit to you is greater than the risk of||
2409|046|S|side effects. Careful monitoring by your doctor may decrease your||
2409|047|S|risk.||
2409|048|S|   Tell your doctor right away if you have any serious side||
2409|049|S|effects, including: new/worsening cough, mouth/throat sores,||
2409|050|S|diarrhea with blood/mucus, symptoms of liver disease (such as||
2409|051|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
2409|052|S|yellowing eyes/skin, dark urine), signs of kidney problems (such||
2409|053|S|as change in the amount of urine, pink/bloody urine), easy||
2409|054|S|bruising/bleeding, swelling hands/ankles/feet, unusual weakness,||
2409|055|S|fast/irregular heartbeat, muscle weakness/pain/cramps,||
2409|056|S|numbness/tingling of arms/legs, loss of coordination, eye||
2409|057|S|redness/pain, sensitivity to light, vision changes.||
2409|058|S|   Nivolumab may cause hormone gland problems (such as thyroid,||
2409|059|S|pituitary, adrenal, pancreas). Your body could make too much or||
2409|060|S|too little hormone. Tell your doctor right away if you have any||
2409|061|S|symptoms such as: cold or heat intolerance, unexplained weight||
2409|062|S|loss/gain, increased thirst/urination, mood or behavior changes||
2409|063|S|(such as decreased sex drive, irritability, forgetfulness).||
2409|064|S|   Get medical help right away if you have any very serious side||
2409|065|S|effects, including: chest pain, shortness of breath.||
2409|066|S|   Nivolumab/relatlimab can commonly cause itching or a rash that||
2409|067|S|is usually not serious. However, you may not be able to tell it||
2409|068|S|apart from a rare rash that could be a sign of a severe reaction.||
2409|069|S|Get medical help right away if you develop any rash or itching.||
2409|070|S|   A very serious allergic reaction to this drug is rare.||
2409|071|S|However, get medical help right away if you notice any symptoms||
2409|072|S|of a serious allergic reaction, including: swollen lymph nodes,||
2409|073|S|rash, itching/swelling (especially of the face/tongue/throat),||
2409|074|S|severe dizziness, trouble breathing.||
2409|075|S|   This is not a complete list of possible side effects. If you||
2409|076|S|notice other effects not listed above, contact your doctor or||
2409|077|S|pharmacist.||
2409|078|S|   In the US -||
2409|079|S|   Call your doctor for medical advice about side effects. You||
2409|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2409|081|S|www.fda.gov/medwatch.||
2409|082|S|   In Canada - Call your doctor for medical advice about side||
2409|083|S|effects. You may report side effects to Health Canada at||
2409|084|S|1-866-234-2345.||
2409|085|B|||
2409|086|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2409|087|P|pharmacist if you are allergic to nivolumab or relatlimab; or if||
2409|088|P|you have any other allergies. This product may contain inactive||
2409|089|P|ingredients, which can cause allergic reactions or other||
2409|090|P|problems. Talk to your pharmacist for more details.||
2409|091|P|   Before using this medication, tell your doctor or pharmacist||
2409|092|P|your medical history, especially of: immune system problems (such||
2409|093|P|as Crohn's disease, ulcerative colitis, lupus), organ transplant,||
2409|094|P|stem cell transplant with donor cells.||
2409|095|P|   Before having surgery, tell your doctor or dentist about all||
2409|096|P|the products you use (including prescription drugs,||
2409|097|P|nonprescription drugs, and herbal products).||
2409|098|P|   Tell your doctor if you are pregnant or plan to become||
2409|099|P|pregnant. You should not become pregnant while using||
2409|100|P|nivolumab/relatlimab. This medication may harm an unborn baby.||
2409|101|P|Your doctor should order a pregnancy test before you start this||
2409|102|P|medication. Ask about reliable forms of birth control while using||
2409|103|P|this medication and for 5 months after the last dose. If you||
2409|104|P|become pregnant, talk to your doctor right away about the risks||
2409|105|P|and benefits of this medication.||
2409|106|P|   It is unknown if this drug passes into breast milk. Because of||
2409|107|P|the possible risk to the infant, breastfeeding is not recommended||
2409|108|P|while using this drug and for 5 months after the last dose.||
2409|109|P|Consult your doctor before breastfeeding.||
2409|110|B|||
2409|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2409|112|I|medications work or increase your risk for serious side effects.||
2409|113|I|This document does not contain all possible drug interactions.||
2409|114|I|Keep a list of all the products you use (including||
2409|115|I|prescription/nonprescription drugs and herbal products) and share||
2409|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
2409|117|I|the dosage of any medicines without your doctor's approval.||
2409|118|B|||
2409|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2409|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2409|121|O|poison control center right away. US residents can call||
2409|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2409|123|B|||
2409|124|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
2409|125|N|function, blood sugar) should be done before and during treatment||
2409|126|N|with this medication. Keep all medical and lab appointments.||
2409|127|N|Consult your doctor for more details.||
2409|128|B|||
2409|129|D|MISSED DOSE:  It is important to get each dose of this medication||
2409|130|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2409|131|D|right away for a new dosing schedule.||
2409|132|B|||
2409|133|R|STORAGE:  Not applicable. This medication is given in a hospital||
2409|134|R|or clinic and will not be stored at home.||
2409|135|B|||
2409|136|A|Information last revised April 2025.||
2409|137|A|Copyright(c) 2025 First Databank, Inc.||
2409|138|B|||
2410|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2410|002|Z|does NOT have all possible information about this product. This||
2410|003|Z|information does not assure that this product is safe, effective,||
2410|004|Z|or appropriate for you. This information is not individual||
2410|005|Z|medical advice and does not substitute for the advice of your||
2410|006|Z|health care professional. Always ask your health care||
2410|007|Z|professional for complete information about this product and your||
2410|008|Z|specific health needs.||
2410|009|B|||
2410|010|T|LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN - INJECTION||
2410|011|B|||
2410|012|C|COMMON BRAND NAME(S): Pluvicto||
2410|013|B|||
2410|014|U|USES:  This medication is used to treat prostate cancer. Lutetium||
2410|015|U|Lu 177 vipivotide tetraxetan is a radioactive drug. It works by||
2410|016|U|attaching to certain cancer cells and causing them to die.||
2410|017|B|||
2410|018|H|HOW TO USE:  This medication is given by injection into a vein by||
2410|019|H|a health care professional. It is given as directed by your||
2410|020|H|doctor, usually once every 6 weeks for up to 6 doses.||
2410|021|H|   The dosage is based on your medical condition, lab tests, and||
2410|022|H|response to treatment.||
2410|023|H|   Drink plenty of fluids before and after treatment with this||
2410|024|H|medication and urinate as often as possible to lessen damage to||
2410|025|H|your bladder. Ask your doctor for more details.||
2410|026|H|   To reduce radiation exposure to others after receiving this||
2410|027|H|medication, avoid close contact (less than 3 feet) with people||
2410|028|H|for 2 days and with children and pregnant women for 7 days. Do||
2410|029|H|not have sexual activity for 7 days. Also, sleep in a different||
2410|030|H|bedroom from other people for 3 days, from children for 7 days,||
2410|031|H|and from pregnant women for 15 days. If you have any questions,||
2410|032|H|ask your doctor or pharmacist.||
2410|033|B|||
2410|034|S|SIDE EFFECTS:  Dizziness, tiredness, headache, nausea, vomiting,||
2410|035|S|diarrhea/constipation, abdominal pain, change in how food tastes,||
2410|036|S|dry mouth, or decreased appetite may occur. If any of these||
2410|037|S|effects last or get worse, tell your doctor or pharmacist||
2410|038|S|promptly.||
2410|039|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
2410|040|S|chips, chew (sugarless) gum, drink water, or use a saliva||
2410|041|S|substitute.||
2410|042|S|   People using this medication may have serious side effects.||
2410|043|S|However, you have been prescribed this drug because your doctor||
2410|044|S|has judged that the benefit to you is greater than the risk of||
2410|045|S|side effects. Careful monitoring by your doctor may decrease your||
2410|046|S|risk.||
2410|047|S|   Tell your doctor right away if you have any serious side||
2410|048|S|effects, including: signs of kidney damage (such as change in||
2410|049|S|amount of urine).||
2410|050|S|   This medication decreases bone marrow function, a severe||
2410|051|S|(possibly fatal) effect that may lead to a low number of blood||
2410|052|S|cells such as red cells, white cells, and platelets. This effect||
2410|053|S|can cause anemia, decrease your body's ability to fight an||
2410|054|S|infection, or cause easy bruising/bleeding. Tell your doctor||
2410|055|S|right away if you develop any of the following unlikely symptoms:||
2410|056|S|unusual tiredness, pale skin, signs of infection (such as sore||
2410|057|S|throat that doesn't go away, fever, chills, painful/burning||
2410|058|S|urination), easy bruising/bleeding.||
2410|059|S|   A very serious allergic reaction to this drug is rare.||
2410|060|S|However, get medical help right away if you notice any symptoms||
2410|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2410|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2410|063|S|breathing.||
2410|064|S|   This is not a complete list of possible side effects. If you||
2410|065|S|notice other effects not listed above, contact your doctor or||
2410|066|S|pharmacist.||
2410|067|S|   In the US -||
2410|068|S|   Call your doctor for medical advice about side effects. You||
2410|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2410|070|S|www.fda.gov/medwatch.||
2410|071|S|   In Canada - Call your doctor for medical advice about side||
2410|072|S|effects. You may report side effects to Health Canada at||
2410|073|S|1-866-234-2345.||
2410|074|B|||
2410|075|P|PRECAUTIONS:  Before using lutetium Lu 177 vipivotide tetraxetan,||
2410|076|P|tell your doctor or pharmacist if you are allergic to it; or if||
2410|077|P|you have any other allergies. This product may contain inactive||
2410|078|P|ingredients, which can cause allergic reactions or other||
2410|079|P|problems. Talk to your pharmacist for more details.||
2410|080|P|   Before using this medication, tell your doctor or pharmacist||
2410|081|P|your medical history, especially of: kidney problems.||
2410|082|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2410|083|P|can make you more dizzy. Do not drive, use machinery, or do||
2410|084|P|anything that needs alertness until you can do it safely. Limit||
2410|085|P|alcoholic beverages. Talk to your doctor if you are using||
2410|086|P|marijuana (cannabis).||
2410|087|P|   This medication can make you more likely to get infections or||
2410|088|P|may make current infections worse. Stay away from anyone who has||
2410|089|P|an infection that may easily spread (such as chickenpox,||
2410|090|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2410|091|P|exposed to an infection or for more details.||
2410|092|P|   Tell your health care professional that you are using lutetium||
2410|093|P|Lu 177 vipivotide tetraxetan before having any||
2410|094|P|immunizations/vaccinations. Avoid contact with people who have||
2410|095|P|recently received live vaccines (such as flu vaccine inhaled||
2410|096|P|through the nose).||
2410|097|P|   To lower the chance of getting cut, bruised, or injured, use||
2410|098|P|caution with sharp objects like razors and nail cutters, and||
2410|099|P|avoid activities such as contact sports.||
2410|100|P|   Before having surgery, tell your doctor or dentist about all||
2410|101|P|the products you use (including prescription drugs,||
2410|102|P|nonprescription drugs, and herbal products).||
2410|103|P|   This medication may affect the ability to have children. Talk||
2410|104|P|to your doctor for details.||
2410|105|P|   Lutetium Lu 177 vipivotide tetraxetan should not be used by||
2410|106|P|women, especially during pregnancy or breastfeeding. It may harm||
2410|107|P|an unborn or breastfeeding baby. Men with female partners of||
2410|108|P|childbearing age should ask about reliable forms of birth control||
2410|109|P|while using this medication and for 14 weeks after the last dose.||
2410|110|P|Consult your doctor if you have any questions about this||
2410|111|P|medication.||
2410|112|B|||
2410|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2410|114|I|medications work or increase your risk for serious side effects.||
2410|115|I|This document does not contain all possible drug interactions.||
2410|116|I|Keep a list of all the products you use (including||
2410|117|I|prescription/nonprescription drugs and herbal products) and share||
2410|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
2410|119|I|the dosage of any medicines without your doctor's approval.||
2410|120|B|||
2410|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2410|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2410|123|O|poison control center right away. US residents can call||
2410|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2410|125|B|||
2410|126|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2410|127|N|kidney/liver function, blood mineral levels) should be done||
2410|128|N|before you start receiving this medication and while you are||
2410|129|N|using it. Keep all medical and lab appointments.||
2410|130|B|||
2410|131|D|MISSED DOSE:  It is important to get each dose of this medication||
2410|132|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2410|133|D|right away for a new dosing schedule. Do not double the dose to||
2410|134|D|catch up.||
2410|135|B|||
2410|136|R|STORAGE:  Not applicable. This medication is given in a hospital||
2410|137|R|or clinic or doctor's office and will not be stored at home.||
2410|138|B|||
2410|139|M|MEDICAL ALERT:  Your condition can cause complications in a||
2410|140|M|medical emergency. For information about enrolling in MedicAlert,||
2410|141|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2410|142|B|||
2410|143|A|Information last revised May 2024.||
2410|144|A|Copyright(c) 2025 First Databank, Inc.||
2410|145|B|||
2411|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2411|002|Z|does NOT have all possible information about this product. This||
2411|003|Z|information does not assure that this product is safe, effective,||
2411|004|Z|or appropriate for you. This information is not individual||
2411|005|Z|medical advice and does not substitute for the advice of your||
2411|006|Z|health care professional. Always ask your health care||
2411|007|Z|professional for complete information about this product and your||
2411|008|Z|specific health needs.||
2411|009|B|||
2411|010|T|BIMEKIZUMAB - INJECTION||
2411|011|F|(BYE-me-KIZ-ue-mab)||
2411|012|B|||
2411|013|C|COMMON BRAND NAME(S): Bimzelx||
2411|014|B|||
2411|015|U|USES:  This medication is used to treat plaque psoriasis and||
2411|016|U|certain types of arthritis (psoriatic arthritis, ankylosing||
2411|017|U|spondylitis, axial spondyloarthritis). It is also used to treat a||
2411|018|U|certain skin disorder (hidradenitis suppurativa). Bimekizumab||
2411|019|U|belongs to a class of drugs known as monoclonal antibodies. It||
2411|020|U|works by blocking certain natural proteins in your body||
2411|021|U|(interleukin-17A and interleukin-17F) that cause inflammation and||
2411|022|U|swelling.||
2411|023|B|||
2411|024|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2411|025|H|Patient Information Leaflet and Instructions for Use leaflet||
2411|026|H|provided by your pharmacist before you start using bimekizumab||
2411|027|H|and each time you get a refill. Ask your health care professional||
2411|028|H|how to prepare and use this medication. If you have any||
2411|029|H|questions, ask your doctor or pharmacist.||
2411|030|H|   Before starting treatment with this medication, your doctor||
2411|031|H|will test you for tuberculosis (TB). Your doctor should also||
2411|032|H|monitor you for symptoms of TB during and after treatment with||
2411|033|H|this drug. If needed, treatment for tuberculosis or other||
2411|034|H|infections should be given before receiving this medication.||
2411|035|H|   Inject this medication under the skin as directed by your||
2411|036|H|doctor. The injection is given in the upper arms, thighs, or||
2411|037|H|abdomen (at least 2 inches from your belly button). The dosage||
2411|038|H|and treatment schedule are based on your medical condition,||
2411|039|H|weight, and response to treatment.||
2411|040|H|   Take the medication out of the refrigerator at least 30 to 45||
2411|041|H|minutes before you inject it to allow it to reach room||
2411|042|H|temperature. Do not warm up this medication any other way (for||
2411|043|H|example, do not heat it in the microwave, place it in hot water,||
2411|044|H|or leave it in direct sunlight). Do not shake the medication.||
2411|045|H|Before using, check this product for cloudiness, particles, or||
2411|046|H|discoloration. If you see any of these things, do not use the||
2411|047|H|liquid. Before injecting each dose, clean the skin you are going||
2411|048|H|to inject into (the injection site) with rubbing alcohol. Change||
2411|049|H|the injection site each time to lessen injury under the skin. Do||
2411|050|H|not inject into skin that is tender, bruised, red, scaly, hard,||
2411|051|H|or areas with scars or stretch marks. To lessen bruising, do not||
2411|052|H|rub the injection site after a shot. Learn how to store and||
2411|053|H|discard medical supplies safely.||
2411|054|H|   Use this medication regularly to get the most benefit from it.||
2411|055|H|To help you remember, mark your calendar with a reminder.||
2411|056|H|   Tell your doctor if your condition does not get better or if||
2411|057|H|it gets worse.||
2411|058|B|||
2411|059|S|SIDE EFFECTS:  Pain, redness, or swelling at the injection site||
2411|060|S|may occur. Cold symptoms (such as runny/stuffy nose) may also||
2411|061|S|occur. If any of these effects last or get worse, tell your||
2411|062|S|doctor or pharmacist promptly.||
2411|063|S|   Remember that this medication has been prescribed because your||
2411|064|S|doctor has judged that the benefit to you is greater than the||
2411|065|S|risk of side effects. Many people using this medication do not||
2411|066|S|have serious side effects.||
2411|067|S|   This medication may lower your ability to fight infections.||
2411|068|S|This may make you more likely to get a serious (rarely fatal)||
2411|069|S|infection or make any infection you have worse. Tell your doctor||
2411|070|S|right away if you have any signs of infection (such as sore||
2411|071|S|throat that doesn't go away, white patches in the mouth, fever,||
2411|072|S|chills).||
2411|073|S|   Tell your doctor right away if you have any serious side||
2411|074|S|effects, including: stomach/abdominal pain, diarrhea with||
2411|075|S|blood/mucus, mental/mood changes (such as depression, anxiety,||
2411|076|S|thoughts of suicide), signs of liver problems (such as||
2411|077|S|nausea/vomiting that doesn't stop, loss of appetite, yellowing||
2411|078|S|eyes/skin, dark urine).||
2411|079|S|   A very serious allergic reaction to this drug is rare.||
2411|080|S|However, get medical help right away if you notice any symptoms||
2411|081|S|of a serious allergic reaction, including: rash, itching/swelling||
2411|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2411|083|S|breathing.||
2411|084|S|   This is not a complete list of possible side effects. If you||
2411|085|S|notice other effects not listed above, contact your doctor or||
2411|086|S|pharmacist.||
2411|087|S|   In the US -||
2411|088|S|   Call your doctor for medical advice about side effects. You||
2411|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2411|090|S|www.fda.gov/medwatch.||
2411|091|S|   In Canada - Call your doctor for medical advice about side||
2411|092|S|effects. You may report side effects to Health Canada at||
2411|093|S|1-866-234-2345.||
2411|094|B|||
2411|095|P|PRECAUTIONS:  Before using bimekizumab, tell your doctor or||
2411|096|P|pharmacist if you are allergic to it; or if you have any other||
2411|097|P|allergies. This product may contain inactive ingredients, which||
2411|098|P|can cause allergic reactions or other problems. Talk to your||
2411|099|P|pharmacist for more details.||
2411|100|P|   Before using this medication, tell your doctor or pharmacist||
2411|101|P|your medical history, especially of: current/recent/returning||
2411|102|P|infection (such as tuberculosis, herpes), bowel disease (such as||
2411|103|P|Crohn's disease, ulcerative colitis), mental/mood problems (such||
2411|104|P|as depression, suicidal thoughts), liver disease.||
2411|105|P|   Bimekizumab can make you more likely to get infections or may||
2411|106|P|make current infections worse. Stay away from anyone who has an||
2411|107|P|infection that may easily spread (such as chickenpox, COVID-19,||
2411|108|P|measles, flu). Talk to your doctor if you have been exposed to an||
2411|109|P|infection or for more details.||
2411|110|P|   Tell your health care professional that you are using||
2411|111|P|bimekizumab before having any immunizations/vaccinations. Avoid||
2411|112|P|contact with people who have recently received live vaccines||
2411|113|P|(such as flu vaccine inhaled through the nose).||
2411|114|P|   Before having surgery, tell your doctor or dentist about all||
2411|115|P|the products you use (including prescription drugs,||
2411|116|P|nonprescription drugs, and herbal products).||
2411|117|P|   During pregnancy, this medication should be used only when||
2411|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
2411|119|P|   It is unknown if this medication passes into breast milk.||
2411|120|P|Consult your doctor before breastfeeding.||
2411|121|B|||
2411|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2411|123|I|medications work or increase your risk for serious side effects.||
2411|124|I|This document does not contain all possible drug interactions.||
2411|125|I|Keep a list of all the products you use (including||
2411|126|I|prescription/nonprescription drugs and herbal products) and share||
2411|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
2411|128|I|the dosage of any medicines without your doctor's approval.||
2411|129|B|||
2411|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2411|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2411|132|O|poison control center right away. US residents can call||
2411|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2411|134|B|||
2411|135|N|NOTES:  Do not share this medication with others.||
2411|136|N|   Lab and/or medical tests (such as liver function, skin exams)||
2411|137|N|should be done before you start using this medication and while||
2411|138|N|you are using it. Keep all medical and lab appointments. Consult||
2411|139|N|your doctor for more details.||
2411|140|B|||
2411|141|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2411|142|D|Use your next dose on your regular schedule (for example, 4 or 8||
2411|143|D|weeks later). Do not double the dose to catch up.||
2411|144|B|||
2411|145|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2411|146|R|medication in the original carton to protect from light. This||
2411|147|R|medication may also be stored at room temperature if needed. If||
2411|148|R|the medication is stored at room temperature, do not put it back||
2411|149|R|in the refrigerator and discard after 25 to 30 days (depending on||
2411|150|R|your brand). Discard any unused portion after use. Keep all||
2411|151|R|medications away from children and pets.||
2411|152|R|   Do not flush medications down the toilet or pour them into a||
2411|153|R|drain unless instructed to do so. Properly discard this product||
2411|154|R|when it is expired or no longer needed. Consult your pharmacist||
2411|155|R|or local waste disposal company.||
2411|156|B|||
2411|157|A|Information last revised April 2025.||
2411|158|A|Copyright(c) 2025 First Databank, Inc.||
2411|159|B|||
2412|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2412|002|Z|does NOT have all possible information about this product. This||
2412|003|Z|information does not assure that this product is safe, effective,||
2412|004|Z|or appropriate for you. This information is not individual||
2412|005|Z|medical advice and does not substitute for the advice of your||
2412|006|Z|health care professional. Always ask your health care||
2412|007|Z|professional for complete information about this product and your||
2412|008|Z|specific health needs.||
2412|009|B|||
2412|010|T|ABACAVIR/DOLUTEGRAVIR/LAMIVUDINE TABLET - FOR ORAL SUSPENSION||
2412|011|F|(a-BAK-a-vir/DOE-loo-TEG-ra-vir/la-MIV-ue-deen)||
2412|012|B|||
2412|013|C|COMMON BRAND NAME(S): Triumeq PD||
2412|014|B|||
2412|015|W|WARNING:  In some people, the abacavir in this product has caused||
2412|016|W|a serious (sometimes fatal) allergic reaction. Your doctor should||
2412|017|W|order a blood test to measure your risk before you start this||
2412|018|W|medication or take it again. If the blood test shows you are at||
2412|019|W|greater risk, you should not take this medication and your doctor||
2412|020|W|should discuss other treatment choices with you. Symptoms of an||
2412|021|W|allergic reaction may include any of the following: rash,||
2412|022|W|itching/swelling (especially of the face/tongue/throat), severe||
2412|023|W|dizziness, trouble breathing, fever, extreme tiredness, nausea,||
2412|024|W|vomiting, diarrhea, stomach pain, muscle aches/pain, joint pain,||
2412|025|W|sore throat, mouth sores, blisters, eye redness/swelling, or||
2412|026|W|cough. Get medical help right away if you experience any of these||
2412|027|W|symptoms. If you have stopped taking abacavir because of an||
2412|028|W|allergic reaction, you must never take any form of abacavir||
2412|029|W|again, or death could result. Tell all of your doctors and||
2412|030|W|pharmacists if you have stopped taking abacavir due to an||
2412|031|W|allergic reaction. Also, properly throw away any unused||
2412|032|W|medications containing abacavir. Read the warning card provided||
2412|033|W|with this medication for more details.||
2412|034|W|   You should be tested for hepatitis B infection before starting||
2412|035|W|this medication. If you have hepatitis B infection and HIV, you||
2412|036|W|may need additional drugs to treat the hepatitis B infection. You||
2412|037|W|may also have a serious worsening of hepatitis symptoms if you||
2412|038|W|stop taking lamivudine. Talk with your doctor before stopping||
2412|039|W|this medication. Your doctor will monitor liver tests for several||
2412|040|W|months after you stop lamivudine. Get medical help right away if||
2412|041|W|you develop symptoms of worsening liver problems.||
2412|042|B|||
2412|043|U|USES:  This product contains 3 drugs: abacavir, dolutegravir, and||
2412|044|U|lamivudine. It is used to help control HIV infection. It helps to||
2412|045|U|decrease the amount of HIV in your body so your immune system can||
2412|046|U|work better. This lowers your chance of getting HIV complications||
2412|047|U|(such as new infections, cancer) and improves your quality of||
2412|048|U|life. Abacavir and lamivudine belong to a class of drugs known as||
2412|049|U|nucleoside reverse transcriptase inhibitors (NRTIs). Dolutegravir||
2412|050|U|belongs to a class of drugs known as integrase inhibitors.||
2412|051|U|   This medication is not a cure for HIV infection. To decrease||
2412|052|U|your risk of spreading HIV disease to others, continue to take||
2412|053|U|all HIV medications exactly as prescribed by your doctor. Use an||
2412|054|U|effective barrier method (latex or polyurethane condoms/dental||
2412|055|U|dams) during sexual activity as directed by your doctor. Do not||
2412|056|U|share personal items (such as needles/syringes, toothbrushes, and||
2412|057|U|razors) that may have contacted blood or other body fluids.||
2412|058|U|Consult your doctor or pharmacist for more details.||
2412|059|B|||
2412|060|H|HOW TO USE:  Read the Medication Guide, Instructions for Use, and||
2412|061|H|Warning Card provided by your pharmacist before you start taking||
2412|062|H|this medication and each time you get a refill. Carry the Warning||
2412|063|H|Card with you at all times. If you have any questions, ask your||
2412|064|H|doctor or pharmacist.||
2412|065|H|   Do not change dosage forms of this medication without checking||
2412|066|H|with your doctor or pharmacist.||
2412|067|H|   Take this medication by mouth with or without food as directed||
2412|068|H|by your doctor, usually once daily. Do not chew, cut, crush, or||
2412|069|H|swallow the tablets whole. The tablet(s) must be mixed in water||
2412|070|H|before taking. Pour 20 milliliters (4 teaspoonfuls) of water into||
2412|071|H|the supplied cup. Use water only. Do not use any other drink or||
2412|072|H|food to prepare the dose. Add the prescribed number of tablet(s)||
2412|073|H|to the water. Swirl the cup gently for 1 to 2 minutes to disperse||
2412|074|H|the tablet(s). If there are any lumps of tablet, swirl the cup||
2412|075|H|until they are gone. Take the dose of medicine within 30 minutes||
2412|076|H|of mixing. To make sure you have taken all of the dose, add||
2412|077|H|another 15 milliliters (3 teaspoonfuls) of drinking water to the||
2412|078|H|cup. Swirl again and drink all of it. Repeat if any medicine||
2412|079|H|remains in the cup.||
2412|080|H|   If you are giving this medication to a child that is unable to||
2412|081|H|use the supplied cup, ask your health care professional for||
2412|082|H|detailed instructions on how to properly give the suspension||
2412|083|H|using a syringe.||
2412|084|H|   If you are taking certain other medications, your doctor may||
2412|085|H|direct you to take additional dolutegravir. Carefully follow your||
2412|086|H|doctor's directions for taking all your medications.||
2412|087|H|   Take this medication at least 2 hours before or 6 hours after||
2412|088|H|taking sucralfate and products containing aluminum or magnesium||
2412|089|H|(such as antacids, laxatives, buffered medications). These||
2412|090|H|products bind with dolutegravir, making it work less well.||
2412|091|H|   If you are also taking calcium or iron supplements (including||
2412|092|H|vitamins/minerals that contain calcium or iron), take this||
2412|093|H|medication at least 2 hours before or 6 hours after these||
2412|094|H|products. Or if you take this medication with food, you can take||
2412|095|H|the supplements at the same time.||
2412|096|H|   If you stop taking any medication containing abacavir even for||
2412|097|H|a short time and then restart the drug, you have an increased||
2412|098|H|chance of developing a very serious (possibly fatal) allergic||
2412|099|H|reaction. Refill your medication before you run out. Do not stop||
2412|100|H|treatment unless directed by your doctor. Before restarting any||
2412|101|H|medication containing abacavir, consult your doctor or||
2412|102|H|pharmacist, and be sure you have easy access to medical care.||
2412|103|H|   It is very important to keep taking this medication (and other||
2412|104|H|HIV medications) exactly as prescribed by your doctor. Do not||
2412|105|H|skip any doses.||
2412|106|H|   For the best effect, take this medication at evenly spaced||
2412|107|H|times. To help you remember, take this medication at the same||
2412|108|H|time every day.||
2412|109|H|   Do not take more or less of this drug than prescribed or stop||
2412|110|H|taking it (or other HIV medicines) even for a short time unless||
2412|111|H|directed to do so by your doctor. Doing so may cause the amount||
2412|112|H|of virus to increase, make the infection more difficult to treat||
2412|113|H|(resistant), or worsen side effects.||
2412|114|B|||
2412|115|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2412|116|S|   Remember that this medication has been prescribed because your||
2412|117|S|doctor has judged that the benefit to you is greater than the||
2412|118|S|risk of side effects. Many people using this medication do not||
2412|119|S|have serious side effects.||
2412|120|S|   As your immune system gets stronger, it can begin to fight off||
2412|121|S|infections you already had, possibly causing disease symptoms to||
2412|122|S|come back. You could also have symptoms if your immune system||
2412|123|S|becomes overactive. This reaction may happen at any time (soon||
2412|124|S|after starting HIV treatment or many months later). Tell your||
2412|125|S|doctor right away if you have any serious symptoms, including:||
2412|126|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
2412|127|S|that doesn't go away, headaches that are severe or don't go away,||
2412|128|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
2412|129|S|changes, signs of infection (such as sore throat that doesn't go||
2412|130|S|away, fever, chills, swollen lymph nodes, non-healing skin||
2412|131|S|sores), signs of an overactive thyroid (such as irritability,||
2412|132|S|nervousness, heat intolerance, fast/pounding/irregular||
2412|133|S|heartbeat).||
2412|134|S|   Tell your doctor right away if you have any serious side||
2412|135|S|effects, including: mental/mood changes (such as depression,||
2412|136|S|anxiety), easy bruising/bleeding, signs of anemia (such as||
2412|137|S|unusual tiredness, fast breathing, pale skin, fast heartbeat),||
2412|138|S|signs of kidney problems (such as change in the amount of urine).||
2412|139|S|   Get medical help right away if you have any very serious side||
2412|140|S|effects, including: signs of pancreatitis (such as nausea,||
2412|141|S|vomiting, stomach/abdominal/back pain, fever).||
2412|142|S|   Rarely, this medication has caused severe (sometimes fatal)||
2412|143|S|liver problems and a buildup of lactic acid in the blood (lactic||
2412|144|S|acidosis). These serious side effects may occur more often in||
2412|145|S|women and obese patients. Get medical help right away if you have||
2412|146|S|any of the following serious symptoms, including: symptoms of||
2412|147|S|liver problems (such as nausea/vomiting that doesn't stop, loss||
2412|148|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2412|149|S|urine), symptoms of lactic acidosis (such as deep/rapid||
2412|150|S|breathing, drowsiness, nausea/vomiting).||
2412|151|S|   This is not a complete list of possible side effects. If you||
2412|152|S|notice other effects not listed above, contact your doctor or||
2412|153|S|pharmacist.||
2412|154|S|   In the US -||
2412|155|S|   Call your doctor for medical advice about side effects. You||
2412|156|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2412|157|S|www.fda.gov/medwatch.||
2412|158|S|   In Canada - Call your doctor for medical advice about side||
2412|159|S|effects. You may report side effects to Health Canada at||
2412|160|S|1-866-234-2345.||
2412|161|B|||
2412|162|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2412|163|P|pharmacist if you are allergic to abacavir, dolutegravir, or||
2412|164|P|lamivudine; or if you have any other allergies. This product may||
2412|165|P|contain inactive ingredients, which can cause allergic reactions||
2412|166|P|or other problems. Talk to your pharmacist for more details.||
2412|167|P|   Before using this medication, tell your doctor or pharmacist||
2412|168|P|your medical history, especially of: kidney problems, liver||
2412|169|P|problems (such as hepatitis B or C, cirrhosis), disease of the||
2412|170|P|pancreas (pancreatitis), alcohol use.||
2412|171|P|   Abacavir may increase your risk of a heart attack. Discuss the||
2412|172|P|risks and benefits of treatment with your doctor and ways to||
2412|173|P|lower your risk of heart disease. Tell your doctor if you have||
2412|174|P|heart problems, if you smoke, or if you have other conditions||
2412|175|P|that increase your risk of heart disease, such as high blood||
2412|176|P|pressure, diabetes, or high cholesterol levels.||
2412|177|P|   Before having surgery, tell your doctor or dentist about all||
2412|178|P|the products you use (including prescription drugs,||
2412|179|P|nonprescription drugs, and herbal products).||
2412|180|P|   This dosage form of abacavir/dolutegravir/lamivudine is not||
2412|181|P|usually used by adults. It is unlikely to be used during||
2412|182|P|pregnancy or breastfeeding. Consult your doctor if you have any||
2412|183|P|questions about this medication.||
2412|184|B|||
2412|185|I|DRUG INTERACTIONS:  See also How to Use section.||
2412|186|I|   Drug interactions may change how your medications work or||
2412|187|I|increase your risk for serious side effects. This document does||
2412|188|I|not contain all possible drug interactions. Keep a list of all||
2412|189|I|the products you use (including prescription/nonprescription||
2412|190|I|drugs and herbal products) and share it with your doctor and||
2412|191|I|pharmacist. Do not start, stop, or change the dosage of any||
2412|192|I|medicines without your doctor's approval.||
2412|193|I|   Some products that may interact with this drug are:||
2412|194|I|dofetilide, orlistat, sorbitol.||
2412|195|I|   Do not take this medication with other products (including||
2412|196|I|those that treat HIV infection) that contain abacavir,||
2412|197|I|lamivudine, or emtricitabine.||
2412|198|B|||
2412|199|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2412|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2412|201|O|poison control center right away. US residents can call||
2412|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2412|203|B|||
2412|204|N|NOTES:  Do not share this medication with others.||
2412|205|N|   Lab and/or medical tests (such as blood tests, liver/kidney||
2412|206|N|function, viral load, T-cell counts) should be done while you are||
2412|207|N|taking this medication. Keep all medical and lab appointments.||
2412|208|N|Consult your doctor for more details.||
2412|209|B|||
2412|210|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2412|211|D|remember. If it is less than 4 hours before the next dose, skip||
2412|212|D|the missed dose. Take your next dose at the regular time. Do not||
2412|213|D|double the dose to catch up.||
2412|214|B|||
2412|215|R|STORAGE:  Store in the original bottle at room temperature away||
2412|216|R|from light and moisture. Do not store in the bathroom. Keep the||
2412|217|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
2412|218|R|when not in use. Keep all medications away from children and||
2412|219|R|pets.||
2412|220|R|   Do not flush medications down the toilet or pour them into a||
2412|221|R|drain unless instructed to do so. Properly discard this product||
2412|222|R|when it is expired or no longer needed. Consult your pharmacist||
2412|223|R|or local waste disposal company.||
2412|224|B|||
2412|225|A|Information last revised April 2025.||
2412|226|A|Copyright(c) 2025 First Databank, Inc.||
2412|227|B|||
2413|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2413|002|Z|does NOT have all possible information about this product. This||
2413|003|Z|information does not assure that this product is safe, effective,||
2413|004|Z|or appropriate for you. This information is not individual||
2413|005|Z|medical advice and does not substitute for the advice of your||
2413|006|Z|health care professional. Always ask your health care||
2413|007|Z|professional for complete information about this product and your||
2413|008|Z|specific health needs.||
2413|009|B|||
2413|010|T|DARIDOREXANT - ORAL||
2413|011|B|||
2413|012|C|COMMON BRAND NAME(S): Quviviq||
2413|013|B|||
2413|014|U|USES:  This medication is used to treat a certain sleep problem||
2413|015|U|(insomnia). It may help you fall asleep and stay asleep longer,||
2413|016|U|so you can get a better night's rest. Daridorexant belongs to a||
2413|017|U|class of drugs known as sedative-hypnotics.||
2413|018|U|   If your insomnia continues for longer than 7 to 10 days after||
2413|019|U|starting treatment, talk to your doctor to see if you need other||
2413|020|U|treatment.||
2413|021|B|||
2413|022|H|HOW TO USE:  Read the Medication Guide provided by your||
2413|023|H|pharmacist before you start taking daridorexant and each time you||
2413|024|H|get a refill. If you have any questions, ask your doctor or||
2413|025|H|pharmacist.||
2413|026|H|   Take this medication by mouth as directed by your doctor,||
2413|027|H|usually 30 minutes before you get into bed. This medication can||
2413|028|H|be taken with or without food, but it may take longer to work if||
2413|029|H|you take it with or right after a meal. Do not take this||
2413|030|H|medication with alcohol or with other drugs that help you sleep.||
2413|031|H|   The dosage is based on your medical condition, response to||
2413|032|H|treatment, and other medications you may be taking. Be sure to||
2413|033|H|tell your doctor and pharmacist about all the products you use||
2413|034|H|(including prescription drugs, nonprescription drugs, and herbal||
2413|035|H|products).||
2413|036|H|   Do not take a dose of this drug unless you have time for a||
2413|037|H|full night's sleep of at least 7 hours. If you have to wake up||
2413|038|H|before that, you may have trouble safely doing anything that||
2413|039|H|needs alertness, such as driving or operating machinery. (See||
2413|040|H|also Precautions section.)||
2413|041|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2413|042|H|using this medication unless your doctor or pharmacist says you||
2413|043|H|may do so safely. Grapefruit can increase the chance of side||
2413|044|H|effects with this medicine. Ask your doctor or pharmacist for||
2413|045|H|more details.||
2413|046|H|   Do not increase your dose or use this drug more often or for||
2413|047|H|longer than prescribed. Your condition will not improve any||
2413|048|H|faster, and your risk of side effects will increase.||
2413|049|H|   Though it helps many people, this medication may sometimes||
2413|050|H|cause addiction. This risk may be higher if you have a substance||
2413|051|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2413|052|H|Take this medication exactly as prescribed to lower the risk of||
2413|053|H|addiction. Ask your doctor or pharmacist for more details.||
2413|054|H|   Tell your doctor if your condition lasts longer than 7 to 10||
2413|055|H|days after starting this medication, or if it gets worse.||
2413|056|B|||
2413|057|S|SIDE EFFECTS:  Dizziness or headache may occur. If any of these||
2413|058|S|effects last or get worse, tell your doctor or pharmacist||
2413|059|S|promptly.||
2413|060|S|   This medication may make you sleepy during the day. Tell your||
2413|061|S|doctor if you have daytime drowsiness. Your dose may need to be||
2413|062|S|adjusted.||
2413|063|S|   Remember that this medication has been prescribed because your||
2413|064|S|doctor has judged that the benefit to you is greater than the||
2413|065|S|risk of side effects. Many people using this medication do not||
2413|066|S|have serious side effects.||
2413|067|S|   Tell your doctor right away if you have any serious side||
2413|068|S|effects, including: mental/mood changes (such as depression,||
2413|069|S|thoughts of suicide), temporary weakness in your legs.||
2413|070|S|   This medication may cause sleep paralysis, which is a||
2413|071|S|temporary inability to move or talk (for up to several minutes)||
2413|072|S|while you are going to sleep or waking up.||
2413|073|S|   Rarely, after taking this drug, people have gotten out of bed||
2413|074|S|and driven vehicles while not fully awake ("sleep-driving").||
2413|075|S|People have also sleepwalked, prepared/eaten food, made phone||
2413|076|S|calls, or had sex while not fully awake. Often, these people do||
2413|077|S|not remember these events. This problem can be dangerous to you||
2413|078|S|or to others. If you find out that you have done any of these||
2413|079|S|activities after taking this medication, tell your doctor right||
2413|080|S|away. Your risk is increased if you use alcohol or other||
2413|081|S|medications that can make you drowsy while taking daridorexant.||
2413|082|S|   A very serious allergic reaction to this drug is rare.||
2413|083|S|However, get medical help right away if you notice any symptoms||
2413|084|S|of a serious allergic reaction, including: rash, itching/swelling||
2413|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2413|086|S|breathing.||
2413|087|S|   This is not a complete list of possible side effects. If you||
2413|088|S|notice other effects not listed above, contact your doctor or||
2413|089|S|pharmacist.||
2413|090|S|   In the US -||
2413|091|S|   Call your doctor for medical advice about side effects. You||
2413|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2413|093|S|www.fda.gov/medwatch.||
2413|094|S|   In Canada - Call your doctor for medical advice about side||
2413|095|S|effects. You may report side effects to Health Canada at||
2413|096|S|1-866-234-2345.||
2413|097|B|||
2413|098|P|PRECAUTIONS:  Before taking daridorexant, tell your doctor or||
2413|099|P|pharmacist if you are allergic to it; or if you have any other||
2413|100|P|allergies. This product may contain inactive ingredients, which||
2413|101|P|can cause allergic reactions or other problems. Talk to your||
2413|102|P|pharmacist for more details.||
2413|103|P|   Before using this medication, tell your doctor or pharmacist||
2413|104|P|your medical history, especially of: a certain sleep disorder||
2413|105|P|(narcolepsy), liver disease, lung disease/breathing problems||
2413|106|P|(such as sleep apnea, chronic obstructive pulmonary||
2413|107|P|disease-COPD), mental/mood problems (such as depression, thoughts||
2413|108|P|of suicide), personal or family history of a substance use||
2413|109|P|disorder (such as overuse of or addiction to drugs/alcohol), a||
2413|110|P|certain muscle weakness disorder (cataplexy).||
2413|111|P|   The effects of this drug can last even after you wake up the||
2413|112|P|next day. The risk of daytime drowsiness is greater if you did||
2413|113|P|not get at least 7 hours of sleep or took a higher dose than||
2413|114|P|recommended. If that is the case, you should not drive or do||
2413|115|P|anything that needs alertness the next day. Alcohol or marijuana||
2413|116|P|(cannabis) can also make you more sleepy. Avoid alcoholic||
2413|117|P|beverages. Talk to your doctor if you are using marijuana||
2413|118|P|(cannabis). Do not drive, use machinery, or do anything that||
2413|119|P|needs alertness until you can do it safely.||
2413|120|P|   Before having surgery, tell your doctor or dentist about all||
2413|121|P|the products you use (including prescription drugs,||
2413|122|P|nonprescription drugs, and herbal products).||
2413|123|P|   Older adults may be more sensitive to the side effects of this||
2413|124|P|drug, especially confusion, unsteadiness, excessive drowsiness.||
2413|125|P|Unsteadiness and drowsiness may increase the risk of falls.||
2413|126|P|   During pregnancy, this medication should be used only when||
2413|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
2413|128|P|   Daridorexant passes into breast milk. Consult your doctor||
2413|129|P|before breastfeeding.||
2413|130|B|||
2413|131|I|DRUG INTERACTIONS:  See also How to Use section.||
2413|132|I|   Drug interactions may change how your medications work or||
2413|133|I|increase your risk for serious side effects. This document does||
2413|134|I|not contain all possible drug interactions. Keep a list of all||
2413|135|I|the products you use (including prescription/nonprescription||
2413|136|I|drugs and herbal products) and share it with your doctor and||
2413|137|I|pharmacist. Do not start, stop, or change the dosage of any||
2413|138|I|medicines without your doctor's approval.||
2413|139|I|   Other medications can affect the removal of daridorexant from||
2413|140|I|your body, which may affect how daridorexant works. Examples||
2413|141|I|include certain azole antifungals (such as itraconazole,||
2413|142|I|ketoconazole), clarithromycin, cobicistat, certain HIV protease||
2413|143|I|inhibitors (such as atazanavir), nefazodone, rifampin, ritonavir,||
2413|144|I|certain drugs used to treat seizures (such as carbamazepine,||
2413|145|I|phenytoin), telithromycin, tucatinib, among others.||
2413|146|I|   The risk of serious side effects (such as slow/shallow||
2413|147|I|breathing, severe drowsiness/dizziness) may be increased if this||
2413|148|I|medication is taken with other products that may also cause||
2413|149|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2413|150|I|if you are taking other products such as opioid pain or cough||
2413|151|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2413|152|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
2413|153|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2413|154|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2413|155|I|diphenhydramine).||
2413|156|I|   Check the labels on all your medicines (such as allergy or||
2413|157|I|cough-and-cold products) because they may contain ingredients||
2413|158|I|that cause drowsiness. Ask your pharmacist about using those||
2413|159|I|products safely.||
2413|160|B|||
2413|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2413|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2413|163|O|poison control center right away. US residents can call||
2413|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2413|165|B|||
2413|166|N|NOTES:  Do not share this medication with others. Sharing it is||
2413|167|N|against the law.||
2413|168|N|   As you get older, your sleep pattern may naturally change and||
2413|169|N|your sleep may be interrupted several times during the night.||
2413|170|N|Consult your doctor or pharmacist for ways to improve your sleep||
2413|171|N|without medication, such as avoiding caffeine and alcohol close||
2413|172|N|to bedtime, avoiding daytime naps, and going to bed at the same||
2413|173|N|time each night.||
2413|174|B|||
2413|175|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
2413|176|D|time to sleep for at least 7 hours afterward.||
2413|177|B|||
2413|178|R|STORAGE:  Store at room temperature away from light and moisture.||
2413|179|R|Do not store in the bathroom. Keep all medications away from||
2413|180|R|children and pets.||
2413|181|R|   Do not flush medications down the toilet or pour them into a||
2413|182|R|drain unless instructed to do so. Properly discard this product||
2413|183|R|when it is expired or no longer needed. Consult your pharmacist||
2413|184|R|or local waste disposal company.||
2413|185|B|||
2413|186|A|Information last revised April 2025.||
2413|187|A|Copyright(c) 2025 First Databank, Inc.||
2413|188|B|||
2414|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2414|002|Z|does NOT have all possible information about this product. This||
2414|003|Z|information does not assure that this product is safe, effective,||
2414|004|Z|or appropriate for you. This information is not individual||
2414|005|Z|medical advice and does not substitute for the advice of your||
2414|006|Z|health care professional. Always ask your health care||
2414|007|Z|professional for complete information about this product and your||
2414|008|Z|specific health needs.||
2414|009|B|||
2414|010|T|MAVACAMTEN - ORAL||
2414|011|B|||
2414|012|C|COMMON BRAND NAME(S): Camzyos||
2414|013|B|||
2414|014|W|WARNING:  Mavacamten may cause heart failure. The risk of heart||
2414|015|W|failure is increased if you are also using certain medications.||
2414|016|W|Be sure to tell your doctor and pharmacist about all the products||
2414|017|W|you use (including prescription drugs, nonprescription drugs, and||
2414|018|W|herbal products). See also Drug Interactions section. Your doctor||
2414|019|W|should also do heart exams before and during treatment with||
2414|020|W|mavacamten. Your doctor may stop treatment with this medication||
2414|021|W|if heart failure occurs. Get medical help right away if you have||
2414|022|W|any symptoms of heart failure (such as shortness of breath,||
2414|023|W|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
2414|024|W|gain).||
2414|025|W|   To receive mavacamten in the United States, you must||
2414|026|W|understand, agree to, and carefully follow the requirements of||
2414|027|W|the REMS Program for this medication. If you live in Canada or||
2414|028|W|any other country, consult your doctor and pharmacist for your||
2414|029|W|country's regulations.||
2414|030|B|||
2414|031|U|USES:  This medication is used to treat a certain heart problem||
2414|032|U|(hypertrophic cardiomyopathy). It works by relaxing the muscles||
2414|033|U|in your heart. Mavacamten may help to increase your ability to||
2414|034|U|exercise and improve symptoms such as shortness of breath and||
2414|035|U|tiredness.||
2414|036|B|||
2414|037|H|HOW TO USE:  Read the Medication Guide provided by your||
2414|038|H|pharmacist before you start taking mavacamten and each time you||
2414|039|H|get a refill. If you have any questions, ask your doctor or||
2414|040|H|pharmacist.||
2414|041|H|   Take this medication by mouth with or without food as directed||
2414|042|H|by your doctor, usually once daily. Swallow the capsules whole.||
2414|043|H|Do not crush or chew the capsules.||
2414|044|H|   The dosage is based on your medical condition, response to||
2414|045|H|treatment, lab tests, and other medications you may be taking. Be||
2414|046|H|sure to tell your doctor and pharmacist about all the products||
2414|047|H|you use (including prescription drugs, nonprescription drugs, and||
2414|048|H|herbal products).||
2414|049|H|   To reduce your risk of side effects, your doctor may direct||
2414|050|H|you to start this medication at a low dose and gradually increase||
2414|051|H|your dose. Follow your doctor's instructions carefully.||
2414|052|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2414|053|H|using this medication unless your doctor or pharmacist says you||
2414|054|H|may do so safely. Grapefruit can increase the chance of side||
2414|055|H|effects with this medicine. Ask your doctor or pharmacist for||
2414|056|H|more details.||
2414|057|H|   Use this medication regularly to get the most benefit from it.||
2414|058|H|To help you remember, take it at the same time each day.||
2414|059|H|   Tell your doctor if your condition lasts or gets worse.||
2414|060|B|||
2414|061|S|SIDE EFFECTS:  See also Warning section.||
2414|062|S|   Dizziness may occur. If this effect lasts or gets worse, tell||
2414|063|S|your doctor or pharmacist promptly.||
2414|064|S|   Remember that this medication has been prescribed because your||
2414|065|S|doctor has judged that the benefit to you is greater than the||
2414|066|S|risk of side effects. Many people using this medication do not||
2414|067|S|have serious side effects.||
2414|068|S|   Get medical help right away if you have any very serious side||
2414|069|S|effects, including: fainting.||
2414|070|S|   A very serious allergic reaction to this drug is rare.||
2414|071|S|However, get medical help right away if you notice any symptoms||
2414|072|S|of a serious allergic reaction, including: rash, itching/swelling||
2414|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2414|074|S|breathing.||
2414|075|S|   This is not a complete list of possible side effects. If you||
2414|076|S|notice other effects not listed above, contact your doctor or||
2414|077|S|pharmacist.||
2414|078|S|   In the US -||
2414|079|S|   Call your doctor for medical advice about side effects. You||
2414|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2414|081|S|www.fda.gov/medwatch.||
2414|082|S|   In Canada - Call your doctor for medical advice about side||
2414|083|S|effects. You may report side effects to Health Canada at||
2414|084|S|1-866-234-2345.||
2414|085|B|||
2414|086|P|PRECAUTIONS:  Before taking mavacamten, tell your doctor or||
2414|087|P|pharmacist if you are allergic to it; or if you have any other||
2414|088|P|allergies. This product may contain inactive ingredients, which||
2414|089|P|can cause allergic reactions or other problems. Talk to your||
2414|090|P|pharmacist for more details.||
2414|091|P|   Before using this medication, tell your doctor or pharmacist||
2414|092|P|your medical history, especially of: other heart problems (such||
2414|093|P|as heart failure, irregular heartbeat), current infection.||
2414|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2414|095|P|can make you more dizzy. Do not drive, use machinery, or do||
2414|096|P|anything that needs alertness until you can do it safely. Limit||
2414|097|P|alcoholic beverages. Talk to your doctor if you are using||
2414|098|P|marijuana (cannabis).||
2414|099|P|   Before having surgery, tell your doctor or dentist about all||
2414|100|P|the products you use (including prescription drugs,||
2414|101|P|nonprescription drugs, and herbal products).||
2414|102|P|   Tell your doctor if you are pregnant or plan to become||
2414|103|P|pregnant. You should not become pregnant while taking mavacamten.||
2414|104|P|Mavacamten may harm an unborn baby. Your doctor should order a||
2414|105|P|pregnancy test before you start this medication. Ask about||
2414|106|P|reliable forms of birth control while using this medication and||
2414|107|P|for 4 months after the last dose. See also Drug Interactions||
2414|108|P|section. If you become pregnant, talk to your doctor right away||
2414|109|P|about the risks and benefits of this medication.||
2414|110|P|   It is unknown if this medication passes into breast milk.||
2414|111|P|Consult your doctor before breastfeeding.||
2414|112|B|||
2414|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2414|114|I|medications work or increase your risk for serious side effects.||
2414|115|I|This document does not contain all possible drug interactions.||
2414|116|I|Keep a list of all the products you use (including||
2414|117|I|prescription/nonprescription drugs and herbal products) and share||
2414|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
2414|119|I|the dosage of any medicines without your doctor's approval.||
2414|120|I|   Other medications can affect the removal of mavacamten from||
2414|121|I|your body, which may affect how mavacamten works. Examples||
2414|122|I|include azole antifungals (such as itraconazole, ketoconazole),||
2414|123|I|belzutifan, cobicistat, dicloxacillin, fluoxetine, fluvoxamine,||
2414|124|I|pacritinib, drugs used to treat seizures (such as carbamazepine,||
2414|125|I|phenytoin), sotorasib, tovorafenib, among others.||
2414|126|I|   This medication can speed up the removal of other medications||
2414|127|I|from your body, which may affect how they work. Examples of||
2414|128|I|affected drugs include elacestrant, quizartinib, revumenib, among||
2414|129|I|others.||
2414|130|I|   This medication may decrease the effectiveness of hormonal||
2414|131|I|birth control such as pills, patch, or ring. This could cause||
2414|132|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2414|133|I|use reliable backup birth control methods while using this||
2414|134|I|medication. Also tell your doctor if you have any new spotting or||
2414|135|I|breakthrough bleeding, because these may be signs that your birth||
2414|136|I|control is not working well.||
2414|137|B|||
2414|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2414|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2414|140|O|poison control center right away. US residents can call||
2414|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2414|142|B|||
2414|143|N|NOTES:  Do not share this medication with others.||
2414|144|N|   Lab and/or medical tests (such as echocardiogram) should be||
2414|145|N|done before you start taking this medication and while you are||
2414|146|N|taking it. Keep all medical and lab appointments. Consult your||
2414|147|N|doctor for more details.||
2414|148|B|||
2414|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2414|150|D|remember. If it is near the time of the next dose, skip the||
2414|151|D|missed dose. Take your next dose at the regular time. Do not||
2414|152|D|double the dose to catch up.||
2414|153|B|||
2414|154|R|STORAGE:  Store at room temperature away from light and moisture.||
2414|155|R|Do not store in the bathroom. Keep all medications away from||
2414|156|R|children and pets.||
2414|157|R|   Do not flush medications down the toilet or pour them into a||
2414|158|R|drain unless instructed to do so. Properly discard this product||
2414|159|R|when it is expired or no longer needed. Consult your pharmacist||
2414|160|R|or local waste disposal company.||
2414|161|B|||
2414|162|A|Information last revised April 2025.||
2414|163|A|Copyright(c) 2025 First Databank, Inc.||
2414|164|B|||
2415|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2415|002|Z|does NOT have all possible information about this product. This||
2415|003|Z|information does not assure that this product is safe, effective,||
2415|004|Z|or appropriate for you. This information is not individual||
2415|005|Z|medical advice and does not substitute for the advice of your||
2415|006|Z|health care professional. Always ask your health care||
2415|007|Z|professional for complete information about this product and your||
2415|008|Z|specific health needs.||
2415|009|B|||
2415|010|T|COPPER-RELEASING 10 YEAR SYSTEM - INTRAUTERINE||
2415|011|B|||
2415|012|C|COMMON BRAND NAME(S): Paragard||
2415|013|B|||
2415|014|U|USES:  This product is a small, flexible device that is placed in||
2415|015|U|the womb (uterus) to prevent pregnancy. It is used by people who||
2415|016|U|want a reversible birth control method that works for a long time||
2415|017|U|(up to 10 years). This device helps prevent pregnancy.||
2415|018|U|   This product does not protect against sexually transmitted||
2415|019|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
2415|020|U|an effective barrier method (latex or polyurethane condom/dental||
2415|021|U|dams) during sexual activity will help to decrease your risk of||
2415|022|U|infection.||
2415|023|B|||
2415|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2415|025|H|from your pharmacist before you start using this product. If you||
2415|026|H|have any questions, ask your doctor or pharmacist.||
2415|027|H|   This device is placed in your uterus by a health care provider||
2415|028|H|during an in-office visit. It is left in place for up to 10||
2415|029|H|years. After the device is placed, schedule a follow-up visit||
2415|030|H|after your first menstrual period to make sure it is still in the||
2415|031|H|proper position.||
2415|032|H|   This device may sometimes move out of place or come out by||
2415|033|H|itself. It is a good habit to check once a month to make sure it||
2415|034|H|is in the proper position. Learn how to carefully check the||
2415|035|H|position of this device from the Patient Information Leaflet||
2415|036|H|and/or your health care provider. If it comes out or if you||
2415|037|H|cannot feel the threads, contact your doctor promptly and use||
2415|038|H|backup birth control (such as condoms, spermicide) to prevent||
2415|039|H|pregnancy until otherwise directed by your doctor.||
2415|040|H|   If you wish to continue this method of birth control after 10||
2415|041|H|years, the used device may be removed and replaced with a new||
2415|042|H|one. Either way, the used device should be removed after 10||
2415|043|H|years. Your health care provider can remove this device whenever||
2415|044|H|you want to stop using this method of birth control.||
2415|045|B|||
2415|046|S|SIDE EFFECTS:  Temporary pain, bleeding, or dizziness during and||
2415|047|S|soon after placement of the device may occur. Your periods may||
2415|048|S|become heavier and longer. You may also have frequent vaginal||
2415|049|S|bleeding (spotting) between periods. If any of these effects last||
2415|050|S|or get worse, tell your doctor promptly.||
2415|051|S|   Remember that this medication device has been prescribed||
2415|052|S|because your doctor has judged that the benefit to you is greater||
2415|053|S|than the risk of side effects. Many people using this device do||
2415|054|S|not have serious side effects.||
2415|055|S|   Tell your doctor right away if you have any serious side||
2415|056|S|effects, including: unusual changes in vaginal bleeding (such as||
2415|057|S|continuous spotting, sudden heavy bleeding, missed periods).||
2415|058|S|   Using an intrauterine device (IUD) may increase your risk for||
2415|059|S|a rare but serious pelvic infection (pelvic inflammatory||
2415|060|S|disease-PID), which can cause permanent damage to sex organs and||
2415|061|S|infertility. The risk is greater in people who have multiple||
2415|062|S|sexual partners, or infection with a sexually transmitted disease||
2415|063|S|(STD), or who have had PID in the past (see also Precautions||
2415|064|S|section). Tell your doctor right away if you have symptoms of||
2415|065|S|PID, including: unexplained fever/chills, lower abdominal/pelvic||
2415|066|S|pain, pain during sexual intercourse, genital sores, unusual||
2415|067|S|vaginal discharge.||
2415|068|S|   A very serious allergic reaction to this drug is rare.||
2415|069|S|However, get medical help right away if you notice any symptoms||
2415|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2415|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2415|072|S|breathing.||
2415|073|S|   This is not a complete list of possible side effects. If you||
2415|074|S|notice other effects not listed above, contact your doctor or||
2415|075|S|pharmacist.||
2415|076|S|   In the US -||
2415|077|S|   Call your doctor for medical advice about side effects. You||
2415|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2415|079|S|www.fda.gov/medwatch.||
2415|080|S|   In Canada - Call your doctor for medical advice about side||
2415|081|S|effects. You may report side effects to Health Canada at||
2415|082|S|1-866-234-2345.||
2415|083|B|||
2415|084|P|PRECAUTIONS:  Before using this medication device, tell your||
2415|085|P|doctor or pharmacist if you are allergic to copper; or if you||
2415|086|P|have any other allergies. This product may contain inactive||
2415|087|P|ingredients, which can cause allergic reactions or other||
2415|088|P|problems. Talk to your pharmacist for more details.||
2415|089|P|   Before using this product, tell your doctor or pharmacist your||
2415|090|P|medical history, especially of: recent pregnancy, current||
2415|091|P|breastfeeding, cancer (especially uterine or cervical cancer),||
2415|092|P|unexplained vaginal bleeding, uterus problems (such as fibroids,||
2415|093|P|pelvic inflammatory disease-PID), Wilson's disease (a disorder in||
2415|094|P|how the body handles copper), conditions that weaken the immune||
2415|095|P|system/increase the risk of infection (such as HIV, leukemia, IV||
2415|096|P|drug abuse).||
2415|097|P|   If you or partner have other sexual partners, this device may||
2415|098|P|not be the best birth control method for you. If you or your||
2415|099|P|partner(s) get a sexually transmitted disease (including HIV,||
2415|100|P|gonorrhea, chlamydia), contact your doctor right away. Ask your||
2415|101|P|doctor if you should continue to use this device for birth||
2415|102|P|control.||
2415|103|P|   Before having surgery, tell your doctor or dentist about all||
2415|104|P|the products you use (including prescription drugs,||
2415|105|P|nonprescription drugs, and herbal products). Also, if you are||
2415|106|P|going to have a medical procedure using heat therapy or an MRI||
2415|107|P|test, tell your healthcare provider and testing personnel that||
2415|108|P|you are using this device. Your procedure or MRI test may need to||
2415|109|P|be adjusted.||
2415|110|P|   This device should not be used during pregnancy. If you become||
2415|111|P|pregnant or think you may be pregnant, tell your doctor right||
2415|112|P|away.||
2415|113|P|   It is unknown if the copper in this device passes into breast||
2415|114|P|milk. However, it is unlikely to pass into breast milk. Consult||
2415|115|P|your doctor before breastfeeding.||
2415|116|B|||
2415|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2415|118|I|medications work or increase your risk for serious side effects.||
2415|119|I|This document does not contain all possible drug interactions.||
2415|120|I|Keep a list of all the products you use (including||
2415|121|I|prescription/nonprescription drugs and herbal products) and share||
2415|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
2415|123|I|the dosage of any medicines without your doctor's approval.||
2415|124|B|||
2415|125|O|OVERDOSE:  This medication device may be harmful if swallowed. If||
2415|126|O|someone has swallowed it and has serious symptoms such as passing||
2415|127|O|out or trouble breathing, call 911. Otherwise, call a poison||
2415|128|O|control center right away. US residents can call 1-800-222-1222.||
2415|129|O|Canada residents can call 1-844-764-7669.||
2415|130|B|||
2415|131|N|NOTES:  You should have regular complete physical exams including||
2415|132|N|pelvic exam and screening for cervical cancer (Pap smear). Keep||
2415|133|N|all medical and lab appointments. Consult your doctor for more||
2415|134|N|details.||
2415|135|B|||
2415|136|D|MISSED DOSE:  Not applicable.||
2415|137|B|||
2415|138|R|STORAGE:  Before use, store at room temperature. Keep all||
2415|139|R|medications and medical devices away from children and pets.||
2415|140|R|   Do not flush medications down the toilet or pour them into a||
2415|141|R|drain unless instructed to do so. Properly discard this product||
2415|142|R|when it is expired or no longer needed. Consult your pharmacist||
2415|143|R|or local waste disposal company.||
2415|144|B|||
2415|145|A|Information last revised October 2025.||
2415|146|A|Copyright(c) 2025 First Databank, Inc.||
2415|147|B|||
2416|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2416|002|Z|does NOT have all possible information about this product. This||
2416|003|Z|information does not assure that this product is safe, effective,||
2416|004|Z|or appropriate for you. This information is not individual||
2416|005|Z|medical advice and does not substitute for the advice of your||
2416|006|Z|health care professional. Always ask your health care||
2416|007|Z|professional for complete information about this product and your||
2416|008|Z|specific health needs.||
2416|009|B|||
2416|010|T|EDARAVONE - ORAL||
2416|011|F|(e-DAR-a-vone)||
2416|012|B|||
2416|013|C|COMMON BRAND NAME(S): Radicava ORS||
2416|014|B|||
2416|015|U|USES:  Edaravone is used to treat a certain type of nerve disease||
2416|016|U|called amyotrophic lateral sclerosis (ALS, also commonly called||
2416|017|U|Lou Gehrig's disease). It helps to slow down the worsening of||
2416|018|U|this disease. However, it is not a cure for ALS, and it does not||
2416|019|U|reverse nerve damage or muscle weakness.||
2416|020|B|||
2416|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2416|022|H|Instructions for Use if available from your pharmacist before you||
2416|023|H|start using edaravone and with each treatment cycle. If you have||
2416|024|H|any questions, ask your doctor or pharmacist.||
2416|025|H|   Take this medication by mouth or through a feeding tube on an||
2416|026|H|empty stomach as directed by your doctor. This medication is||
2416|027|H|usually taken in the morning after not eating overnight (for at||
2416|028|H|least 8 hours after a high-fat meal, 6 hours after a low-fat||
2416|029|H|meal, 2 hours after a calorie supplement). Do not eat or drink||
2416|030|H|(except for water) for at least 1 hour after taking your||
2416|031|H|medication.||
2416|032|H|   For the first treatment cycle, this medication is usually||
2416|033|H|taken once daily for 14 days, followed by no edaravone for 14||
2416|034|H|days. After that, each treatment cycle is usually scheduled as||
2416|035|H|edaravone taken once daily for 10 days out of a 14-day period,||
2416|036|H|followed by no edaravone for 14 days. Follow your doctor's||
2416|037|H|instructions carefully on how to use this medication.||
2416|038|H|   Shake the medication well before using. Carefully measure the||
2416|039|H|medication using the provided dose-measuring syringe. Do not use||
2416|040|H|a household spoon because you may not get the correct dose.||
2416|041|H|   Use this medication regularly to get the most benefit from it.||
2416|042|H|To help you remember, mark your calendar with a reminder.||
2416|043|B|||
2416|044|S|SIDE EFFECTS:  Bruising, problems walking, tiredness, or headache||
2416|045|S|may occur. If any of these effects last or get worse, tell your||
2416|046|S|doctor or pharmacist promptly.||
2416|047|S|   Remember that this medication has been prescribed because your||
2416|048|S|doctor has judged that the benefit to you is greater than the||
2416|049|S|risk of side effects. Many people using this medication do not||
2416|050|S|have serious side effects.||
2416|051|S|   A very serious allergic reaction to this drug is rare.||
2416|052|S|However, get medical help right away if you notice any symptoms||
2416|053|S|of a serious allergic reaction, including: rash, itching/swelling||
2416|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2416|055|S|breathing.||
2416|056|S|   This is not a complete list of possible side effects. If you||
2416|057|S|notice other effects not listed above, contact your doctor or||
2416|058|S|pharmacist.||
2416|059|S|   In the US -||
2416|060|S|   Call your doctor for medical advice about side effects. You||
2416|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2416|062|S|www.fda.gov/medwatch.||
2416|063|S|   In Canada - Call your doctor for medical advice about side||
2416|064|S|effects. You may report side effects to Health Canada at||
2416|065|S|1-866-234-2345.||
2416|066|B|||
2416|067|P|PRECAUTIONS:  Before using edaravone, tell your doctor or||
2416|068|P|pharmacist if you are allergic to it; or if you have any other||
2416|069|P|allergies. This product may contain inactive ingredients||
2416|070|P|(including sulfites such as sodium bisulfite), which can cause||
2416|071|P|allergic reactions or other problems. Talk to your pharmacist for||
2416|072|P|more details.||
2416|073|P|   Before using this medication, tell your doctor or pharmacist||
2416|074|P|your medical history, especially of: asthma.||
2416|075|P|   Before having surgery, tell your doctor or dentist about all||
2416|076|P|the products you use (including prescription drugs,||
2416|077|P|nonprescription drugs, and herbal products).||
2416|078|P|   During pregnancy, this medication should be used only when||
2416|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
2416|080|P|   It is unknown if this medication passes into breast milk.||
2416|081|P|Consult your doctor before breastfeeding.||
2416|082|B|||
2416|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2416|084|I|medications work or increase your risk for serious side effects.||
2416|085|I|This document does not contain all possible drug interactions.||
2416|086|I|Keep a list of all the products you use (including||
2416|087|I|prescription/nonprescription drugs and herbal products) and share||
2416|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
2416|089|I|the dosage of any medicines without your doctor's approval.||
2416|090|B|||
2416|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2416|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2416|093|O|poison control center right away. US residents can call||
2416|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2416|095|B|||
2416|096|N|NOTES:  Do not share this medication with others.||
2416|097|N|   Lab and/or medical tests may be done while you are using this||
2416|098|N|medication. Keep all medical and lab appointments.||
2416|099|B|||
2416|100|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2416|101|D|next dose at the regular time. Do not double the dose to catch||
2416|102|D|up.||
2416|103|B|||
2416|104|R|STORAGE:  Store the bottle upright at room temperature away from||
2416|105|R|light. Discard medication 15 days after opening bottle, or 30||
2416|106|R|days from date of shipment, whichever is sooner. Keep all||
2416|107|R|medications away from children and pets.||
2416|108|R|   Do not flush medications down the toilet or pour them into a||
2416|109|R|drain unless instructed to do so. Properly discard this product||
2416|110|R|when it is expired or no longer needed. Consult your pharmacist||
2416|111|R|or local waste disposal company.||
2416|112|B|||
2416|113|A|Information last revised October 2024.||
2416|114|A|Copyright(c) 2025 First Databank, Inc.||
2416|115|B|||
2417|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2417|002|Z|does NOT have all possible information about this product. This||
2417|003|Z|information does not assure that this product is safe, effective,||
2417|004|Z|or appropriate for you. This information is not individual||
2417|005|Z|medical advice and does not substitute for the advice of your||
2417|006|Z|health care professional. Always ask your health care||
2417|007|Z|professional for complete information about this product and your||
2417|008|Z|specific health needs.||
2417|009|B|||
2417|010|T|TIRZEPATIDE (DIABETES) - INJECTION||
2417|011|F|(tir-ZEP-a-tide)||
2417|012|B|||
2417|013|C|COMMON BRAND NAME(S): Mounjaro||
2417|014|B|||
2417|015|W|WARNING:  This medication can cause a certain type of thyroid||
2417|016|W|tumor (thyroid C-cell tumors) in rats. It is unknown if this||
2417|017|W|medication can cause similar tumors in humans. Talk with your||
2417|018|W|doctor about the benefits and risks of treatment with this||
2417|019|W|medication. Do not use this medication if you have a||
2417|020|W|personal/family history of a certain type of cancer (medullary||
2417|021|W|thyroid carcinoma) or a certain inherited disease (multiple||
2417|022|W|endocrine neoplasia syndrome type 2 or MEN 2). While using this||
2417|023|W|medication, tell your doctor right away if you notice any signs||
2417|024|W|of thyroid tumors, including an unusual growth or lump in the||
2417|025|W|neck, difficulty swallowing, shortness of breath, unusual/lasting||
2417|026|W|hoarseness.||
2417|027|B|||
2417|028|U|USES:  Tirzepatide is used with a proper diet and exercise||
2417|029|U|program to control high blood sugar in people with type 2||
2417|030|U|diabetes. Controlling high blood sugar helps prevent kidney||
2417|031|U|damage, blindness, nerve problems, loss of limbs, and sexual||
2417|032|U|function problems. It lowers blood sugar by causing the release||
2417|033|U|of your body's natural insulin and decreasing the amount of sugar||
2417|034|U|your liver makes.||
2417|035|B|||
2417|036|H|HOW TO USE:  Read the Medication Guide and Instructions For Use||
2417|037|H|provided by your pharmacist before you start using tirzepatide||
2417|038|H|and each time you get a refill. Ask your health care professional||
2417|039|H|how to prepare and use this medication. If you have any||
2417|040|H|questions, ask your doctor or pharmacist.||
2417|041|H|   Inject this medication under the skin as directed by your||
2417|042|H|doctor, usually once every 7 days. The injection is given in the||
2417|043|H|thigh, abdomen, or upper arm. This medication may be used with or||
2417|044|H|without meals. The dosage is based on your medical condition and||
2417|045|H|response to treatment. To reduce your risk of side effects, your||
2417|046|H|doctor may direct you to start this medication at a low dose and||
2417|047|H|gradually increase your dose. Follow your doctor's instructions||
2417|048|H|carefully.||
2417|049|H|   Before using, check this product for particles or||
2417|050|H|discoloration. If either is present, do not use the liquid.||
2417|051|H|Before injecting each dose, clean the skin you are going to||
2417|052|H|inject into (the injection site) with rubbing alcohol. Change the||
2417|053|H|injection site each week to lessen injury under the skin. To||
2417|054|H|lessen bruising, do not rub the injection site after a shot.||
2417|055|H|Learn how to store and discard medical supplies safely.||
2417|056|H|   Use this medication regularly to get the most benefit from it.||
2417|057|H|To help you remember, mark your calendar with a reminder. If||
2417|058|H|needed, the day of weekly use may be changed as long as the time||
2417|059|H|between two doses is at least 3 days. Carefully follow the||
2417|060|H|medication treatment plan, meal plan, and exercise program your||
2417|061|H|doctor has recommended.||
2417|062|H|   Tell your doctor if your condition does not get better or if||
2417|063|H|it gets worse (your blood sugar is too high or too low).||
2417|064|B|||
2417|065|S|SIDE EFFECTS:  See also Warning section.||
2417|066|S|   Swelling/redness/itching at the injection site, tiredness,||
2417|067|S|loss of appetite, nausea, vomiting, upset stomach, diarrhea, or||
2417|068|S|constipation may occur. If any of these effects last or get||
2417|069|S|worse, tell your doctor or pharmacist promptly.||
2417|070|S|   Remember that this medication has been prescribed because your||
2417|071|S|doctor has judged that the benefit to you is greater than the||
2417|072|S|risk of side effects. Many people using this medication do not||
2417|073|S|have serious side effects.||
2417|074|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2417|075|S|Contact your doctor promptly if you notice any symptoms of||
2417|076|S|dehydration, such as unusual dry mouth/thirst, fast heartbeat, or||
2417|077|S|dizziness/lightheadedness.||
2417|078|S|   Tell your doctor right away if you have any serious side||
2417|079|S|effects, including: signs of kidney problems (such as change in||
2417|080|S|the amount of urine), vision changes (such as decreased/blurred||
2417|081|S|vision).||
2417|082|S|   Get medical help right away if you have any very serious side||
2417|083|S|effects, including: signs of pancreas or gallbladder disease||
2417|084|S|(such as nausea/vomiting that doesn't stop, severe||
2417|085|S|stomach/abdominal pain).||
2417|086|S|   Tirzepatide does not usually cause low blood sugar||
2417|087|S|(hypoglycemia). Low blood sugar may occur if this drug is||
2417|088|S|prescribed with other diabetes medications, or if you do not get||
2417|089|S|enough calories from food, or if you do unusually heavy exercise.||
2417|090|S|Talk with your doctor or pharmacist about whether the dose of||
2417|091|S|your other diabetes medication(s) needs to be lowered. Symptoms||
2417|092|S|of low blood sugar include sudden sweating, shaking, fast||
2417|093|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
2417|094|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
2417|095|S|treat low blood sugar. If you don't have these reliable forms of||
2417|096|S|glucose, rapidly raise your blood sugar by eating a quick source||
2417|097|S|of sugar such as table sugar, honey, or candy, or drink fruit||
2417|098|S|juice or non-diet soda. Tell your doctor right away about the||
2417|099|S|reaction and the use of this product. To help prevent low blood||
2417|100|S|sugar, eat meals on a regular schedule, and do not skip meals.||
2417|101|S|Check with your doctor or pharmacist to find out what you should||
2417|102|S|do if you miss a meal.||
2417|103|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
2417|104|S|thirst/urination. If these symptoms occur, tell your doctor right||
2417|105|S|away. Your doctor may need to adjust your diabetes medication,||
2417|106|S|exercise program, or diet.||
2417|107|S|   A very serious allergic reaction to this drug is rare.||
2417|108|S|However, get medical help right away if you notice any symptoms||
2417|109|S|of a serious allergic reaction, including: rash, itching/swelling||
2417|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2417|111|S|breathing.||
2417|112|S|   This is not a complete list of possible side effects. If you||
2417|113|S|notice other effects not listed above, contact your doctor or||
2417|114|S|pharmacist.||
2417|115|S|   In the US -||
2417|116|S|   Call your doctor for medical advice about side effects. You||
2417|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2417|118|S|www.fda.gov/medwatch.||
2417|119|S|   In Canada - Call your doctor for medical advice about side||
2417|120|S|effects. You may report side effects to Health Canada at||
2417|121|S|1-866-234-2345.||
2417|122|B|||
2417|123|P|PRECAUTIONS:  See also Warning section.||
2417|124|P|   Before using tirzepatide, tell your doctor or pharmacist if||
2417|125|P|you are allergic to it; or if you have any other allergies. This||
2417|126|P|product may contain inactive ingredients, which can cause||
2417|127|P|allergic reactions or other problems. Talk to your pharmacist for||
2417|128|P|more details.||
2417|129|P|   Before using this medication, tell your doctor or pharmacist||
2417|130|P|your medical history, especially of: a certain eye problem||
2417|131|P|(diabetic retinopathy), a disease of the pancreas (pancreatitis),||
2417|132|P|gallbladder disease, kidney problems, stomach/intestinal||
2417|133|P|disorders (such as gastroparesis, digestion problems).||
2417|134|P|   You may experience blurred vision, dizziness, or drowsiness||
2417|135|P|due to extremely low or high blood sugar. Do not drive, use||
2417|136|P|machinery, or do anything that needs alertness or clear vision||
2417|137|P|until you can do it safely.||
2417|138|P|   Limit alcohol while using this medication because it can||
2417|139|P|increase your risk of developing low blood sugar.||
2417|140|P|   It may be harder to control your blood sugar when your body is||
2417|141|P|stressed (such as due to fever, infection, injury, or surgery).||
2417|142|P|Consult your doctor because this may require a change in your||
2417|143|P|treatment plan, medications, or blood sugar testing.||
2417|144|P|   Before having surgery, tell your doctor or dentist about all||
2417|145|P|the products you use (including prescription drugs,||
2417|146|P|nonprescription drugs, and herbal products).||
2417|147|P|   During pregnancy, this medication should be used only when||
2417|148|P|clearly needed. Discuss the risks and benefits with your doctor.||
2417|149|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
2417|150|P|your doctor for managing your blood sugar while pregnant. Your||
2417|151|P|doctor may change your diabetes treatment during your pregnancy||
2417|152|P|(such as diet and medications including insulin).||
2417|153|P|   This medication passes into breast milk. Consult your doctor||
2417|154|P|before breastfeeding.||
2417|155|B|||
2417|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2417|157|I|medications work or increase your risk for serious side effects.||
2417|158|I|This document does not contain all possible drug interactions.||
2417|159|I|Keep a list of all the products you use (including||
2417|160|I|prescription/nonprescription drugs and herbal products) and share||
2417|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
2417|162|I|the dosage of any medicines without your doctor's approval.||
2417|163|I|   Beta-blocker medications (such as metoprolol, propranolol,||
2417|164|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
2417|165|I|heartbeat you would usually feel when your blood sugar falls too||
2417|166|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
2417|167|I|dizziness, hunger, or sweating, are not affected by these drugs.||
2417|168|I|   Many drugs can affect your blood sugar, making it harder to||
2417|169|I|control. Before you start, stop, or change any medication, talk||
2417|170|I|with your doctor or pharmacist about how the medication may||
2417|171|I|affect your blood sugar. Check your blood sugar regularly as||
2417|172|I|directed and share the results with your doctor. Tell your doctor||
2417|173|I|right away if you have symptoms of high or low blood sugar. (See||
2417|174|I|also Side Effects section.) Your doctor may need to adjust your||
2417|175|I|diabetes medication, exercise program, or diet.||
2417|176|I|   Do not use this medication with any other product that||
2417|177|I|contains tirzepatide.||
2417|178|I|   This medication may decrease the effectiveness of birth||
2417|179|I|control pills especially when you first start treatment and when||
2417|180|I|the dose is increased. This could cause pregnancy. Discuss with||
2417|181|I|your doctor or pharmacist if you should use reliable backup birth||
2417|182|I|control methods for 4 weeks after starting this medication and||
2417|183|I|for 4 weeks after each increase in dose of tirzepatide. Also tell||
2417|184|I|your doctor if you have any new spotting or breakthrough||
2417|185|I|bleeding, because these may be signs that your birth control||
2417|186|I|pills are not working well.||
2417|187|B|||
2417|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2417|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2417|190|O|poison control center right away. US residents can call||
2417|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2417|192|B|||
2417|193|N|NOTES:  Do not share this medication with others.||
2417|194|N|   Attend a diabetes education program to learn more about how to||
2417|195|N|manage your diabetes with medications, diet, exercise, and||
2417|196|N|regular medical exams.||
2417|197|N|   Learn the symptoms of high and low blood sugar and how to||
2417|198|N|treat low blood sugar. Check your blood sugar regularly as||
2417|199|N|directed.||
2417|200|N|   Lab and/or medical tests (such as kidney function, fasting||
2417|201|N|blood glucose, hemoglobin A1c) should be done while you are using||
2417|202|N|this medication. Keep all medical and lab appointments. Consult||
2417|203|N|your doctor for more details.||
2417|204|B|||
2417|205|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2417|206|D|If it has been more than 4 days after the missed dose, skip the||
2417|207|D|missed dose. Use your next dose on your regular scheduled day. Do||
2417|208|D|not double the dose to catch up.||
2417|209|B|||
2417|210|R|STORAGE:  Store in the refrigerator. Do not freeze. This||
2417|211|R|medication may also be stored at room temperature. If the||
2417|212|R|medication is stored at room temperature, discard after 21 or 30||
2417|213|R|days (depending on your brand). Keep all medications away from||
2417|214|R|children and pets.||
2417|215|R|   Do not flush medications down the toilet or pour them into a||
2417|216|R|drain unless instructed to do so. Properly discard this product||
2417|217|R|when it is expired or no longer needed. Consult your pharmacist||
2417|218|R|or local waste disposal company.||
2417|219|B|||
2417|220|M|MEDICAL ALERT:  Your condition can cause complications in a||
2417|221|M|medical emergency. For information about enrolling in MedicAlert,||
2417|222|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2417|223|B|||
2417|224|A|Information last revised September 2025.||
2417|225|A|Copyright(c) 2025 First Databank, Inc.||
2417|226|B|||
2418|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2418|002|Z|does NOT have all possible information about this product. This||
2418|003|Z|information does not assure that this product is safe, effective,||
2418|004|Z|or appropriate for you. This information is not individual||
2418|005|Z|medical advice and does not substitute for the advice of your||
2418|006|Z|health care professional. Always ask your health care||
2418|007|Z|professional for complete information about this product and your||
2418|008|Z|specific health needs.||
2418|009|B|||
2418|010|T|VONOPRAZAN/AMOXICILLIN/CLARITHROMYCIN - ORAL||
2418|011|F|(von-OH-pra-zan/a-MOX-i-SIL-in/kla-RITH-roe-MYE-sin)||
2418|012|B|||
2418|013|C|COMMON BRAND NAME(S): Voquezna Triple Pak||
2418|014|B|||
2418|015|U|USES:  This product is used to treat an infection caused by the||
2418|016|U|bacteria H. pylori. This bacteria can cause stomach/intestinal||
2418|017|U|ulcers and irritation/swelling of the lining of the stomach. It||
2418|018|U|may also increase the risk of stomach cancer. Treating the||
2418|019|U|infection will help the ulcers get better and reduces the risk of||
2418|020|U|serious damage to the lining of the stomach/intestines (such as||
2418|021|U|bleeding, tearing).||
2418|022|U|   Vonoprazan is an acid blocker. It works by blocking acid||
2418|023|U|production in the stomach. Decreasing excess stomach acid can||
2418|024|U|help ulcers heal. Amoxicillin and clarithromycin are antibiotics||
2418|025|U|used to treat a wide variety of bacterial infections (including||
2418|026|U|H. pylori). Treating the infection helps the ulcers heal and||
2418|027|U|reduces the risk of ulcers returning. Amoxicillin is a||
2418|028|U|penicillin-type antibiotic and clarithromycin is a macrolide-type||
2418|029|U|antibiotic. They work by stopping the growth of bacteria. The||
2418|030|U|antibiotics in this product treat only bacterial infections.||
2418|031|U|Antibiotics do not work for viral infections (such as common||
2418|032|U|cold, flu). Using any antibiotic when it is not needed can cause||
2418|033|U|it to not work for future infections.||
2418|034|B|||
2418|035|H|HOW TO USE:  This product comes as a package with 14 separate||
2418|036|H|dosing cards. Each card contains the morning and evening doses of||
2418|037|H|this medication (a 1-day supply). Consult your doctor or||
2418|038|H|pharmacist for instructions on the proper use of this product.||
2418|039|H|   Take this medication by mouth with or without food as directed||
2418|040|H|by your doctor, usually 1 dose (4 pills) twice daily (once in the||
2418|041|H|morning and once in the evening, about 12 hours apart).||
2418|042|H|   For the best effect, take this product at evenly spaced times.||
2418|043|H|To help you remember, take this product at the same times every||
2418|044|H|day. Continue to take this medication until the full prescribed||
2418|045|H|amount is finished, even if symptoms disappear after a few days.||
2418|046|H|Stopping the medication too early may result in a return of the||
2418|047|H|infection.||
2418|048|H|   Tell your doctor if your condition lasts or gets worse.||
2418|049|B|||
2418|050|S|SIDE EFFECTS:  Diarrhea, headache, nausea, vomiting, or abnormal||
2418|051|S|taste in your mouth may occur. If any of these effects last or||
2418|052|S|get worse, tell your doctor or pharmacist promptly.||
2418|053|S|   Remember that this medication has been prescribed because your||
2418|054|S|doctor has judged that the benefit to you is greater than the||
2418|055|S|risk of side effects. Many people using this medication do not||
2418|056|S|have serious side effects.||
2418|057|S|   Tell your doctor right away if you have any serious side||
2418|058|S|effects, including: muscle weakness, signs of liver disease (such||
2418|059|S|as nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
2418|060|S|urine), easy bruising/bleeding, signs of kidney problems (such as||
2418|061|S|change in the amount of urine, bloody urine), mental/mood changes||
2418|062|S|(such as agitation, confusion).||
2418|063|S|   Get medical help right away if you have any very serious side||
2418|064|S|effects, including: severe dizziness, fainting, fast/irregular||
2418|065|S|heartbeat.||
2418|066|S|   This medication may rarely cause a severe intestinal condition||
2418|067|S|due to a bacteria called C. difficile. This condition may occur||
2418|068|S|during treatment or weeks to months after treatment has stopped.||
2418|069|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2418|070|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2418|071|S|stool.||
2418|072|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2418|073|S|products because they may make symptoms worse.||
2418|074|S|   This medication may sometimes cause oral thrush or a new yeast||
2418|075|S|infection. Contact your doctor if you notice white patches in||
2418|076|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2418|077|S|   A very serious allergic reaction to this drug is rare.||
2418|078|S|However, get medical help right away if you notice any symptoms||
2418|079|S|of a serious allergic reaction, including: fever, swollen lymph||
2418|080|S|nodes, rash, itching/swelling (especially of the||
2418|081|S|face/tongue/throat), severe dizziness, trouble breathing.||
2418|082|S|   Amoxicillin can commonly cause a mild rash that is usually not||
2418|083|S|serious. However, you may not be able to tell it apart from a||
2418|084|S|rare rash that could be a sign of a severe allergic reaction. Get||
2418|085|S|medical help right away if you develop any rash.||
2418|086|S|   This is not a complete list of possible side effects. If you||
2418|087|S|notice other effects not listed above, contact your doctor or||
2418|088|S|pharmacist.||
2418|089|S|   In the US -||
2418|090|S|   Call your doctor for medical advice about side effects. You||
2418|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2418|092|S|www.fda.gov/medwatch.||
2418|093|S|   In Canada - Call your doctor for medical advice about side||
2418|094|S|effects. You may report side effects to Health Canada at||
2418|095|S|1-866-234-2345.||
2418|096|B|||
2418|097|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2418|098|P|pharmacist if you are allergic to vonoprazan, amoxicillin, or||
2418|099|P|clarithromycin; or to penicillins (such as ampicillin),||
2418|100|P|cephalosporins (such as cephalexin), or macrolide antibiotics||
2418|101|P|(such as erythromycin); or if you have any other allergies. This||
2418|102|P|product may contain inactive ingredients, which can cause||
2418|103|P|allergic reactions or other problems. Talk to your pharmacist for||
2418|104|P|more details.||
2418|105|P|   Before using this medication, tell your doctor or pharmacist||
2418|106|P|your medical history, especially of: liver disease (including||
2418|107|P|liver problems with past clarithromycin use), kidney disease,||
2418|108|P|heart disease (coronary artery disease, heart attack), a certain||
2418|109|P|type of muscle disease (myasthenia gravis), a certain type of||
2418|110|P|viral infection (infectious mononucleosis).||
2418|111|P|   Some symptoms may actually be signs of a more serious||
2418|112|P|condition. Get medical help right away if you have: heartburn||
2418|113|P|with lightheadedness/sweating/dizziness, chest/jaw/left arm pain||
2418|114|P|(especially with shortness of breath, unusual sweating),||
2418|115|P|unexplained weight loss.||
2418|116|P|   Clarithromycin may cause a condition that affects the heart||
2418|117|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2418|118|P|serious (rarely fatal) fast/irregular heartbeat and other||
2418|119|P|symptoms (such as severe dizziness, fainting) that need medical||
2418|120|P|attention right away.||
2418|121|P|   The risk of QT prolongation may be increased if you have||
2418|122|P|certain medical conditions or are taking other drugs that may||
2418|123|P|cause QT prolongation. Before using this product, tell your||
2418|124|P|doctor or pharmacist of all the drugs you take and if you have||
2418|125|P|any of the following conditions: certain heart problems (heart||
2418|126|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2418|127|P|history of certain heart problems (QT prolongation in the EKG,||
2418|128|P|sudden cardiac death).||
2418|129|P|   Low levels of potassium or magnesium in the blood may also||
2418|130|P|increase your risk of QT prolongation. This risk may increase if||
2418|131|P|you use certain drugs (such as diuretics/"water pills") or if you||
2418|132|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2418|133|P|Talk to your doctor about using this product safely.||
2418|134|P|   Before having surgery, tell your doctor or dentist about all||
2418|135|P|the products you use (including prescription drugs,||
2418|136|P|nonprescription drugs, and herbal products).||
2418|137|P|   This medication may cause live bacterial vaccines (such as||
2418|138|P|typhoid vaccine) to not work well. Tell your health care||
2418|139|P|professional that you are using this medication before having any||
2418|140|P|immunizations/vaccinations.||
2418|141|P|   Older adults may be more sensitive to the side effects of this||
2418|142|P|drug, especially QT prolongation (see above) and C. difficile||
2418|143|P|infection (see Side Effects section).||
2418|144|P|   During pregnancy, this product should be used only when||
2418|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
2418|146|P|   This medication passes into breast milk. Consult your doctor||
2418|147|P|before breastfeeding.||
2418|148|B|||
2418|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2418|150|I|medications work or increase your risk for serious side effects.||
2418|151|I|This document does not contain all possible drug interactions.||
2418|152|I|Keep a list of all the products you use (including||
2418|153|I|prescription/nonprescription drugs and herbal products) and share||
2418|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
2418|155|I|the dosage of any medicines without your doctor's approval.||
2418|156|I|   A product that may interact with this drug is: methotrexate||
2418|157|I|(especially high-dose treatment).||
2418|158|I|   Many drugs besides clarithromycin may affect the heart rhythm||
2418|159|I|(QT prolongation), including amiodarone, disopyramide,||
2418|160|I|dofetilide, pacritinib, pimozide, procainamide, quinidine,||
2418|161|I|sotalol, among others.||
2418|162|I|   Other medications can affect the removal of clarithromycin and||
2418|163|I|vonoprazan from your body, which may affect how these medications||
2418|164|I|work. Examples include efavirenz, nevirapine, rifamycins (such as||
2418|165|I|rifabutin), among others.||
2418|166|I|   Clarithromycin can slow down the removal of other medications||
2418|167|I|from your body, which may affect how they work. Examples of||
2418|168|I|affected drugs include colchicine, digoxin, some drugs used to||
2418|169|I|treat erectile dysfunction-ED/pulmonary hypertension (such as||
2418|170|I|sildenafil, tadalafil), ergot alkaloids (such as ergotamine,||
2418|171|I|dihydroergotamine), flibanserin, lomitapide, mavacamten, some||
2418|172|I|statin drugs (such as lovastatin, simvastatin), tamsulosin,||
2418|173|I|tolvaptan, ticagrelor, among others.||
2418|174|I|   Some products need stomach acid so that the body can absorb||
2418|175|I|them properly. Vonoprazan decreases stomach acid, so it may||
2418|176|I|change how well these products work. Some affected products||
2418|177|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
2418|178|I|pazopanib, rilpivirine, certain azole antifungals (itraconazole,||
2418|179|I|ketoconazole, posaconazole), among others.||
2418|180|I|   This medication may interfere with certain lab tests (such as||
2418|181|I|urine glucose test), possibly causing false test results. Make||
2418|182|I|sure lab personnel and all your doctors know you use this drug.||
2418|183|B|||
2418|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2418|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2418|186|O|poison control center right away. US residents can call||
2418|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2418|188|O|Symptoms of overdose may include: change in the amount of urine.||
2418|189|B|||
2418|190|N|NOTES:  Do not share this medication with others.||
2418|191|N|   This medication has been prescribed for your current condition||
2418|192|N|only. Do not use it later for another infection unless your||
2418|193|N|doctor tells you to.||
2418|194|N|   Lab and/or medical tests may be done while you are taking this||
2418|195|N|medication. Keep all medical and lab appointments. Consult your||
2418|196|N|doctor for more details.||
2418|197|B|||
2418|198|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2418|199|D|remember. If it is more than 4 hours after the missed dose, skip||
2418|200|D|the missed dose. Take your next dose at the regular time. Do not||
2418|201|D|double the dose to catch up.||
2418|202|B|||
2418|203|R|STORAGE:  Store at room temperature away from light and moisture.||
2418|204|R|Do not store in the bathroom. Keep all medications away from||
2418|205|R|children and pets.||
2418|206|R|   Do not flush medications down the toilet or pour them into a||
2418|207|R|drain unless instructed to do so. Properly discard this product||
2418|208|R|when it is expired or no longer needed. Consult your pharmacist||
2418|209|R|or local waste disposal company.||
2418|210|B|||
2418|211|A|Information last revised November 2025.||
2418|212|A|Copyright(c) 2025 First Databank, Inc.||
2418|213|B|||
2419|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2419|002|Z|does NOT have all possible information about this product. This||
2419|003|Z|information does not assure that this product is safe, effective,||
2419|004|Z|or appropriate for you. This information is not individual||
2419|005|Z|medical advice and does not substitute for the advice of your||
2419|006|Z|health care professional. Always ask your health care||
2419|007|Z|professional for complete information about this product and your||
2419|008|Z|specific health needs.||
2419|009|B|||
2419|010|T|VONOPRAZAN/AMOXICILLIN - ORAL||
2419|011|F|(von-OH-pra-zan/a-MOX-i-SIL-in)||
2419|012|B|||
2419|013|C|COMMON BRAND NAME(S): Voquezna Dual Pak||
2419|014|B|||
2419|015|U|USES:  This product is used to treat an infection caused by the||
2419|016|U|bacteria H. pylori. This bacteria can cause stomach/intestinal||
2419|017|U|ulcers and irritation/swelling of the lining of the stomach. It||
2419|018|U|may also increase the risk of stomach cancer. Treating the||
2419|019|U|infection will help the ulcers get better and reduces the risk of||
2419|020|U|serious damage to the lining of the stomach/intestines (such as||
2419|021|U|bleeding, tearing).||
2419|022|U|   Vonoprazan is an acid blocker. It works by blocking acid||
2419|023|U|production in the stomach. Decreasing excess stomach acid can||
2419|024|U|help ulcers heal. Amoxicillin is an antibiotic used to treat a||
2419|025|U|wide variety of bacterial infections (including H. pylori).||
2419|026|U|Treating the infection helps the ulcers heal and reduces the risk||
2419|027|U|of ulcers returning. Amoxicillin is a penicillin-type antibiotic.||
2419|028|U|It works by stopping the growth of bacteria. Amoxicillin treats||
2419|029|U|only bacterial infections. It will not work for viral infections||
2419|030|U|(such as common cold, flu). Using any antibiotic when it is not||
2419|031|U|needed can cause it to not work for future infections.||
2419|032|B|||
2419|033|H|HOW TO USE:  This product comes as a package with 14 separate||
2419|034|H|dosing cards. Each card contains the morning, mid-day, and||
2419|035|H|evening doses of this medication (a 1-day supply). The morning||
2419|036|H|and evening doses have 3 pills, and the mid-day dose has 2 pills.||
2419|037|H|Consult your doctor or pharmacist for instructions on the proper||
2419|038|H|use of this product.||
2419|039|H|   Take this medication by mouth with or without food as directed||
2419|040|H|by your doctor, usually 1 dose 3 times daily.||
2419|041|H|   For the best effect, take this product at evenly spaced times.||
2419|042|H|To help you remember, take this product at the same times every||
2419|043|H|day. Continue to take this medication until the full prescribed||
2419|044|H|amount is finished, even if symptoms disappear after a few days.||
2419|045|H|Stopping the medication too early may result in a return of the||
2419|046|H|infection.||
2419|047|H|   Tell your doctor if your condition lasts or gets worse.||
2419|048|B|||
2419|049|S|SIDE EFFECTS:  Diarrhea, nausea, or vomiting may occur. If any of||
2419|050|S|these effects last or get worse, tell your doctor or pharmacist||
2419|051|S|promptly.||
2419|052|S|   Remember that this medication has been prescribed because your||
2419|053|S|doctor has judged that the benefit to you is greater than the||
2419|054|S|risk of side effects. Many people using this medication do not||
2419|055|S|have serious side effects.||
2419|056|S|   Tell your doctor right away if you have any serious side||
2419|057|S|effects, including: signs of liver disease (such as||
2419|058|S|nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
2419|059|S|urine), easy bruising/bleeding, signs of kidney problems (such as||
2419|060|S|change in the amount of urine, bloody urine).||
2419|061|S|   This medication may rarely cause a severe intestinal condition||
2419|062|S|due to a bacteria called C. difficile. This condition may occur||
2419|063|S|during treatment or weeks to months after treatment has stopped.||
2419|064|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2419|065|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2419|066|S|stool.||
2419|067|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2419|068|S|products because they may make symptoms worse.||
2419|069|S|   This medication may sometimes cause oral thrush or a new yeast||
2419|070|S|infection. Contact your doctor if you notice white patches in||
2419|071|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2419|072|S|   A very serious allergic reaction to this drug is rare.||
2419|073|S|However, get medical help right away if you notice any symptoms||
2419|074|S|of a serious allergic reaction, including: fever, swollen lymph||
2419|075|S|nodes, rash, itching/swelling (especially of the||
2419|076|S|face/tongue/throat), severe dizziness, trouble breathing.||
2419|077|S|   Amoxicillin can commonly cause a mild rash that is usually not||
2419|078|S|serious. However, you may not be able to tell it apart from a||
2419|079|S|rare rash that could be a sign of a severe allergic reaction. Get||
2419|080|S|medical help right away if you develop any rash.||
2419|081|S|   This is not a complete list of possible side effects. If you||
2419|082|S|notice other effects not listed above, contact your doctor or||
2419|083|S|pharmacist.||
2419|084|S|   In the US -||
2419|085|S|   Call your doctor for medical advice about side effects. You||
2419|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2419|087|S|www.fda.gov/medwatch.||
2419|088|S|   In Canada - Call your doctor for medical advice about side||
2419|089|S|effects. You may report side effects to Health Canada at||
2419|090|S|1-866-234-2345.||
2419|091|B|||
2419|092|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2419|093|P|pharmacist if you are allergic to vonoprazan or amoxicillin; or||
2419|094|P|to penicillins (such as ampicillin), cephalosporins (such as||
2419|095|P|cephalexin); or if you have any other allergies. This product may||
2419|096|P|contain inactive ingredients, which can cause allergic reactions||
2419|097|P|or other problems. Talk to your pharmacist for more details.||
2419|098|P|   Before using this medication, tell your doctor or pharmacist||
2419|099|P|your medical history, especially of: liver disease, kidney||
2419|100|P|disease, a certain type of viral infection (infectious||
2419|101|P|mononucleosis).||
2419|102|P|   Some symptoms may actually be signs of a more serious||
2419|103|P|condition. Get medical help right away if you have: heartburn||
2419|104|P|with lightheadedness/sweating/dizziness, chest/jaw/left arm pain||
2419|105|P|(especially with shortness of breath, unusual sweating),||
2419|106|P|unexplained weight loss.||
2419|107|P|   Before having surgery, tell your doctor or dentist about all||
2419|108|P|the products you use (including prescription drugs,||
2419|109|P|nonprescription drugs, and herbal products).||
2419|110|P|   Amoxicillin may cause live bacterial vaccines (such as typhoid||
2419|111|P|vaccine) to not work well. Tell your health care professional||
2419|112|P|that you are using this medication before having any||
2419|113|P|immunizations/vaccinations.||
2419|114|P|   Older adults may be more sensitive to the side effects of this||
2419|115|P|drug, especially C. difficile infection (see Side Effects||
2419|116|P|section).||
2419|117|P|   During pregnancy, this product should be used only when||
2419|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
2419|119|P|   This medication passes into breast milk. Consult your doctor||
2419|120|P|before breastfeeding.||
2419|121|B|||
2419|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2419|123|I|medications work or increase your risk for serious side effects.||
2419|124|I|This document does not contain all possible drug interactions.||
2419|125|I|Keep a list of all the products you use (including||
2419|126|I|prescription/nonprescription drugs and herbal products) and share||
2419|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
2419|128|I|the dosage of any medicines without your doctor's approval.||
2419|129|I|   A product that may interact with this drug is: methotrexate||
2419|130|I|(especially high-dose treatment).||
2419|131|I|   Other medications can affect the removal of vonoprazan from||
2419|132|I|your body, which may affect how vonoprazan works. Examples||
2419|133|I|include rifamycins (such as rifabutin), among others.||
2419|134|I|   Some products need stomach acid so that the body can absorb||
2419|135|I|them properly. Vonoprazan decreases stomach acid, so it may||
2419|136|I|change how well these products work. Some affected products||
2419|137|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
2419|138|I|pazopanib, rilpivirine, certain azole antifungals (itraconazole,||
2419|139|I|ketoconazole, posaconazole), among others.||
2419|140|I|   This medication may interfere with certain lab tests (such as||
2419|141|I|urine glucose test), possibly causing false test results. Make||
2419|142|I|sure lab personnel and all your doctors know you use this drug.||
2419|143|B|||
2419|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2419|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2419|146|O|poison control center right away. US residents can call||
2419|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2419|148|O|Symptoms of overdose may include: change in the amount of urine.||
2419|149|B|||
2419|150|N|NOTES:  Do not share this medication with others.||
2419|151|N|   This medication has been prescribed for your current condition||
2419|152|N|only. Do not use it later for another infection unless your||
2419|153|N|doctor tells you to.||
2419|154|N|   Lab and/or medical tests may be done while you are taking this||
2419|155|N|medication. Keep all medical and lab appointments. Consult your||
2419|156|N|doctor for more details.||
2419|157|B|||
2419|158|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2419|159|D|remember. If it is more than 4 hours after the missed dose, skip||
2419|160|D|the missed dose. Take your next dose at the regular time. Do not||
2419|161|D|double the dose to catch up.||
2419|162|B|||
2419|163|R|STORAGE:  Store at room temperature away from light and moisture.||
2419|164|R|Do not store in the bathroom. Keep all medications away from||
2419|165|R|children and pets.||
2419|166|R|   Do not flush medications down the toilet or pour them into a||
2419|167|R|drain unless instructed to do so. Properly discard this product||
2419|168|R|when it is expired or no longer needed. Consult your pharmacist||
2419|169|R|or local waste disposal company.||
2419|170|B|||
2419|171|A|Information last revised November 2025.||
2419|172|A|Copyright(c) 2025 First Databank, Inc.||
2419|173|B|||
2420|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2420|002|Z|does NOT have all possible information about this product. This||
2420|003|Z|information does not assure that this product is safe, effective,||
2420|004|Z|or appropriate for you. This information is not individual||
2420|005|Z|medical advice and does not substitute for the advice of your||
2420|006|Z|health care professional. Always ask your health care||
2420|007|Z|professional for complete information about this product and your||
2420|008|Z|specific health needs.||
2420|009|B|||
2420|010|T|DONEPEZIL PATCH - TRANSDERMAL||
2420|011|F|(doe-NEP-e-zil)||
2420|012|B|||
2420|013|C|COMMON BRAND NAME(S): Adlarity||
2420|014|B|||
2420|015|U|USES:  Donepezil is used to treat confusion (dementia) related to||
2420|016|U|Alzheimer's disease. It does not cure Alzheimer's disease, but it||
2420|017|U|may improve memory, awareness, and the ability to perform daily||
2420|018|U|functions. This medication is an enzyme blocker that works by||
2420|019|U|restoring the balance of natural substances (neurotransmitters)||
2420|020|U|in the brain.||
2420|021|B|||
2420|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
2420|023|H|Instructions for Use provided by your pharmacist before you start||
2420|024|H|using this medication and each time you get a refill. Follow all||
2420|025|H|instructions for how to properly apply and use the patch. If you||
2420|026|H|have any questions, ask your doctor or pharmacist.||
2420|027|H|   Apply the patch to the skin as directed by your doctor,||
2420|028|H|usually once weekly. Do not open the sealed pouch until ready to||
2420|029|H|use. Do not cut the patch or use a damaged patch.||
2420|030|H|   Before use, remove one sealed pouch (containing the patch)||
2420|031|H|from the refrigerator and allow it to reach room temperature. Do||
2420|032|H|not warm up the patch any other way by using other heat sources||
2420|033|H|such a microwave, hair dryer, heating pad, or direct sunlight.||
2420|034|H|The patch should be applied within 24 hours after taking it out||
2420|035|H|of the refrigerator. Choose a clean, dry, area of skin with||
2420|036|H|little or no hair to apply the patch. The recommended application||
2420|037|H|site is the back (avoiding the spine). If you need to, you may||
2420|038|H|apply the patch to the upper buttocks or upper outer thighs.||
2420|039|H|Avoid areas where the patch might be rubbed off by tight clothing||
2420|040|H|or undergarments. Do not apply to skin that is red, irritated, or||
2420|041|H|cut. Do not shave or use creams, lotions, or powder on the||
2420|042|H|application site.||
2420|043|H|   Wash your hands before and after handling the patch. Peel off||
2420|044|H|the backing from the patch and apply the patch to the chosen||
2420|045|H|application site. Press the patch firmly in place for about 30||
2420|046|H|seconds to make sure it stays on. Only one patch should be||
2420|047|H|applied at a time. When changing your patch, remove the old||
2420|048|H|patch, fold it in half with the sticky side together, and throw||
2420|049|H|it away out of reach of children and pets. Do not flush the patch||
2420|050|H|down the toilet. You may use mineral oil or baby oil to wipe off||
2420|051|H|any remaining stickiness left by the old patch at the application||
2420|052|H|site. Apply a new patch to a different area to prevent skin||
2420|053|H|irritation. Do not apply a new patch to the same area for at||
2420|054|H|least 2 weeks.||
2420|055|H|   While wearing the patch, avoid exposure to heat for long||
2420|056|H|periods of time (see also Precautions section). However, keep the||
2420|057|H|patch on during showers or baths.||
2420|058|H|   The dosage is based on your medical condition and response to||
2420|059|H|treatment. To reduce your risk of side effects (such as nausea||
2420|060|H|and diarrhea), your doctor will start this medication at a low||
2420|061|H|dose and gradually increase your dose over weeks to months.||
2420|062|H|Follow your doctor's instructions carefully. Do not increase your||
2420|063|H|dose or use this drug more often than prescribed. If you stop||
2420|064|H|using this medication, contact your doctor for instructions||
2420|065|H|before you start using it again.||
2420|066|H|   If your doctor is changing your treatment with donepezil from||
2420|067|H|the tablet form to this patch form, carefully follow your||
2420|068|H|doctor's directions for when to start using the patch and when to||
2420|069|H|stop taking the tablet(s). Ask your doctor or pharmacist if you||
2420|070|H|have any questions.||
2420|071|H|   Use this medication regularly to get the most benefit from it.||
2420|072|H|To help you remember, change the patch on the same day each week.||
2420|073|H|Mark your calendar with a reminder. It may take several weeks||
2420|074|H|before you get the full benefit of this drug.||
2420|075|H|   If the patch falls off before it is time to change it, do not||
2420|076|H|try to reapply the patch. Choose a new application site and apply||
2420|077|H|a new patch. Then replace the new patch 7 days later to start a||
2420|078|H|new weekly schedule.||
2420|079|H|   Tell your doctor if your condition gets worse.||
2420|080|B|||
2420|081|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, loss of appetite,||
2420|082|S|dizziness, drowsiness, tiredness, trouble sleeping, shakiness||
2420|083|S|(tremor), or muscle cramps may occur as your body adjusts to the||
2420|084|S|drug. These effects usually last 1 to 3 weeks and then lessen.||
2420|085|S|Redness, itching, or irritation at the application site may also||
2420|086|S|occur. If any of these effects last or get worse, tell your||
2420|087|S|doctor or pharmacist promptly.||
2420|088|S|   Remember that this medication has been prescribed because your||
2420|089|S|doctor has judged that the benefit to you is greater than the||
2420|090|S|risk of side effects. Many people using this medication do not||
2420|091|S|have serious side effects.||
2420|092|S|   Tell your doctor right away if you have any serious side||
2420|093|S|effects, including: trouble urinating, severe stomach/abdominal||
2420|094|S|pain, black stools, vomit that looks like coffee grounds.||
2420|095|S|   Get medical help right away if you have any very serious side||
2420|096|S|effects, including: slow/fast/irregular heartbeat, severe||
2420|097|S|dizziness, fainting, seizures.||
2420|098|S|   A very serious allergic reaction to this drug is rare.||
2420|099|S|However, get medical help right away if you notice any symptoms||
2420|100|S|of a serious allergic reaction, including: rash, itching/swelling||
2420|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2420|102|S|breathing.||
2420|103|S|   This is not a complete list of possible side effects. If you||
2420|104|S|notice other effects not listed above, contact your doctor or||
2420|105|S|pharmacist.||
2420|106|S|   In the US -||
2420|107|S|   Call your doctor for medical advice about side effects. You||
2420|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2420|109|S|www.fda.gov/medwatch.||
2420|110|S|   In Canada - Call your doctor for medical advice about side||
2420|111|S|effects. You may report side effects to Health Canada at||
2420|112|S|1-866-234-2345.||
2420|113|B|||
2420|114|P|PRECAUTIONS:  Before using donepezil, tell your doctor or||
2420|115|P|pharmacist if you are allergic to it; or if you have any other||
2420|116|P|allergies. This product may contain inactive ingredients, which||
2420|117|P|can cause allergic reactions or other problems. Talk to your||
2420|118|P|pharmacist for more details.||
2420|119|P|   Before using this medication, tell your doctor or pharmacist||
2420|120|P|your medical history, especially of: breathing problems (such as||
2420|121|P|asthma, chronic obstructive pulmonary disease), seizures,||
2420|122|P|stomach/intestinal disease (such as ulcers, bleeding), trouble||
2420|123|P|urinating (such as enlarged prostate).||
2420|124|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2420|125|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2420|126|P|machinery, or do anything that needs alertness until you can do||
2420|127|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2420|128|P|are using marijuana (cannabis).||
2420|129|P|   Donepezil may cause a condition that affects the heart rhythm||
2420|130|P|(QT prolongation). QT prolongation can rarely cause serious||
2420|131|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2420|132|P|as severe dizziness, fainting) that need medical attention right||
2420|133|P|away.||
2420|134|P|   The risk of QT prolongation may be increased if you have||
2420|135|P|certain medical conditions or are taking other drugs that may||
2420|136|P|cause QT prolongation. Before using donepezil, tell your doctor||
2420|137|P|or pharmacist of all the drugs you take and if you have any of||
2420|138|P|the following conditions: certain heart problems (heart failure,||
2420|139|P|slow heartbeat, QT prolongation in the EKG), family history of||
2420|140|P|certain heart problems (QT prolongation in the EKG, sudden||
2420|141|P|cardiac death).||
2420|142|P|   Low levels of potassium or magnesium in the blood may also||
2420|143|P|increase your risk of QT prolongation. This risk may increase if||
2420|144|P|you use certain drugs (such as diuretics/"water pills") or if you||
2420|145|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2420|146|P|Talk to your doctor about using donepezil safely.||
2420|147|P|   While wearing your patch, avoid long exposure to direct heat||
2420|148|P|(such as prolonged direct sunlight, heating pads, electric||
2420|149|P|blankets, heat lamps, saunas, hot tubs). Heat may cause more drug||
2420|150|P|to be released into your body, increasing the chance of side||
2420|151|P|effects.||
2420|152|P|   If you are going to have an MRI test, tell testing personnel||
2420|153|P|that you are using this patch. Some patches may contain metals||
2420|154|P|that can cause serious burns during an MRI. Ask your doctor||
2420|155|P|whether you will need to remove your patch before the test and||
2420|156|P|apply a new patch afterward, and how to do so properly.||
2420|157|P|   Before having surgery, tell your doctor or dentist about all||
2420|158|P|the products you use (including prescription drugs,||
2420|159|P|nonprescription drugs, and herbal products).||
2420|160|P|   Older adults may be more sensitive to the side effects of this||
2420|161|P|drug, especially QT prolongation (see above).||
2420|162|P|   During pregnancy, this medication should be used only when||
2420|163|P|clearly needed. Discuss the risks and benefits with your doctor.||
2420|164|P|   It is unknown if this medication passes into breast milk.||
2420|165|P|Consult your doctor before breastfeeding.||
2420|166|B|||
2420|167|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2420|168|I|medications work or increase your risk for serious side effects.||
2420|169|I|This document does not contain all possible drug interactions.||
2420|170|I|Keep a list of all the products you use (including||
2420|171|I|prescription/nonprescription drugs and herbal products) and share||
2420|172|I|it with your doctor and pharmacist. Do not start, stop, or change||
2420|173|I|the dosage of any medicines without your doctor's approval.||
2420|174|I|   Some products that may interact with this drug are:||
2420|175|I|aspirin/non-steroidal anti-inflammatory drugs (such as ibuprofen,||
2420|176|I|naproxen).||
2420|177|I|   Check all prescription and nonprescription medicine labels||
2420|178|I|carefully since many medications contain pain relievers/fever||
2420|179|I|reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that if||
2420|180|I|taken together with donepezil may increase your risk for||
2420|181|I|stomach/intestinal bleeding. However, if your doctor has told you||
2420|182|I|to take low-dose aspirin to prevent heart attack or stroke||
2420|183|I|(usually 81-162 milligrams a day), you should keep taking the||
2420|184|I|aspirin unless your doctor tells you not to. Ask your doctor or||
2420|185|I|pharmacist for more details.||
2420|186|B|||
2420|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2420|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2420|189|O|poison control center right away. US residents can call||
2420|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2420|191|O|Symptoms of overdose may include nausea/vomiting that is severe||
2420|192|O|or doesn't stop, excessive sweating, very slow heartbeat, slow or||
2420|193|O|shallow breathing, seizures.||
2420|194|B|||
2420|195|N|NOTES:  Do not share this medication with others.||
2420|196|N|   Lab and/or medical tests (such as weight) should be done while||
2420|197|N|you are using this medication. Keep all medical and lab||
2420|198|N|appointments. Consult your doctor for more details.||
2420|199|B|||
2420|200|D|MISSED DOSE:  If you forget to change the patch, remove the old||
2420|201|D|patch and apply a new patch as soon as you remember. Then||
2420|202|D|continue to change the patch 7 days later to start a new weekly||
2420|203|D|cycle. Do not apply 2 patches to catch up.||
2420|204|B|||
2420|205|R|STORAGE:  Store in the refrigerator. Keep the patch in the sealed||
2420|206|R|pouch until ready to use. Keep all medications away from children||
2420|207|R|and pets.||
2420|208|R|   Do not flush medications down the toilet or pour them into a||
2420|209|R|drain unless instructed to do so. Properly discard this product||
2420|210|R|when it is expired or no longer needed. Consult your pharmacist||
2420|211|R|or local waste disposal company.||
2420|212|B|||
2420|213|A|Information last revised February 2025.||
2420|214|A|Copyright(c) 2025 First Databank, Inc.||
2420|215|B|||
2421|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2421|002|Z|does NOT have all possible information about this product. This||
2421|003|Z|information does not assure that this product is safe, effective,||
2421|004|Z|or appropriate for you. This information is not individual||
2421|005|Z|medical advice and does not substitute for the advice of your||
2421|006|Z|health care professional. Always ask your health care||
2421|007|Z|professional for complete information about this product and your||
2421|008|Z|specific health needs.||
2421|009|B|||
2421|010|T|TREPROSTINIL POWDER - INHALATION||
2421|011|F|(tre-PROS-ti-nil)||
2421|012|B|||
2421|013|C|COMMON BRAND NAME(S): Tyvaso DPI||
2421|014|B|||
2421|015|U|USES:  This medication is used to treat a type of high blood||
2421|016|U|pressure in the lungs (pulmonary arterial hypertension).||
2421|017|U|Treprostinil helps to increase your ability to exercise and||
2421|018|U|improves symptoms such as shortness of breath and tiredness. It||
2421|019|U|works by relaxing and widening the blood vessels (arteries) in||
2421|020|U|the lungs and other parts of the body so that blood can flow more||
2421|021|U|easily. This medication belongs to a class of drugs known as||
2421|022|U|vasodilators.||
2421|023|B|||
2421|024|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
2421|025|H|your pharmacist before you start using treprostinil and each time||
2421|026|H|you get a refill. Follow the illustrated directions for the||
2421|027|H|proper use of this medication. If you have any questions, ask||
2421|028|H|your doctor or pharmacist.||
2421|029|H|   This medication comes in a single-use cartridge. Do not||
2421|030|H|swallow or open the cartridges. Inhale the contents of the||
2421|031|H|cartridge by mouth using the inhaler device as directed by your||
2421|032|H|doctor, usually 4 times daily during waking hours, at least 4||
2421|033|H|hours apart. This medication must always be used with its own||
2421|034|H|special inhaler device. Always discard your old inhaler device||
2421|035|H|after 7 days of use and use a new inhaler device.||
2421|036|H|   Leave the cartridges sealed in the blister card until just||
2421|037|H|before use. If stored in the refrigerator, bring the cartridge||
2421|038|H|and inhaler device to room temperature for 10 minutes before||
2421|039|H|using. Inhale the cartridge contents as directed to make sure you||
2421|040|H|inhale all of the drug. Do not shake the inhaler after placing||
2421|041|H|the cartridge into the inhaler device. Be sure to inhale deeply||
2421|042|H|through the mouthpiece when using this drug. Hold your breath for||
2421|043|H|as long as you comfortably can. Do not exhale or blow into the||
2421|044|H|inhaler device. If two or more cartridges are prescribed, use||
2421|045|H|only 1 cartridge at a time. Do not get this medication on the||
2421|046|H|skin. If this happens, rinse the area with water.||
2421|047|H|   The dosage is based on your medical condition and response to||
2421|048|H|treatment.||
2421|049|H|   To reduce your risk of side effects, your doctor may direct||
2421|050|H|you to start this medication at a low dose and gradually increase||
2421|051|H|your dose. Follow your doctor's instructions carefully.||
2421|052|H|   Use this medication regularly to get the most benefit from it.||
2421|053|H|To help you remember, use it at the same times each day.||
2421|054|H|   Do not increase your dose or use this drug more often or for||
2421|055|H|longer than prescribed. Your condition will not improve any||
2421|056|H|faster, and your risk of side effects will increase.||
2421|057|H|   Tell your doctor if your condition does not get better or if||
2421|058|H|it gets worse.||
2421|059|B|||
2421|060|S|SIDE EFFECTS:  Cough, headache, nausea, dizziness, or||
2421|061|S|lightheadedness may occur. If any of these effects last or get||
2421|062|S|worse, tell your doctor or pharmacist promptly.||
2421|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
2421|064|S|slowly when rising from a sitting or lying position.||
2421|065|S|   Remember that this medication has been prescribed because your||
2421|066|S|doctor has judged that the benefit to you is greater than the||
2421|067|S|risk of side effects. Many people using this medication do not||
2421|068|S|have serious side effects.||
2421|069|S|   Tell your doctor right away if you have any serious side||
2421|070|S|effects, including: unusual bleeding/bruising.||
2421|071|S|   A very serious allergic reaction to this drug is rare.||
2421|072|S|However, get medical help right away if you notice any symptoms||
2421|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2421|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2421|075|S|breathing.||
2421|076|S|   This is not a complete list of possible side effects. If you||
2421|077|S|notice other effects not listed above, contact your doctor or||
2421|078|S|pharmacist.||
2421|079|S|   In the US -||
2421|080|S|   Call your doctor for medical advice about side effects. You||
2421|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2421|082|S|www.fda.gov/medwatch.||
2421|083|S|   In Canada - Call your doctor for medical advice about side||
2421|084|S|effects. You may report side effects to Health Canada at||
2421|085|S|1-866-234-2345.||
2421|086|B|||
2421|087|P|PRECAUTIONS:  Before using treprostinil, tell your doctor or||
2421|088|P|pharmacist if you are allergic to it; or if you have any other||
2421|089|P|allergies. This product may contain inactive ingredients, which||
2421|090|P|can cause allergic reactions or other problems. Talk to your||
2421|091|P|pharmacist for more details.||
2421|092|P|   Before using this medication, tell your doctor or pharmacist||
2421|093|P|your medical history, especially of: low blood pressure, liver||
2421|094|P|problems, bleeding problems, other breathing problems (such as||
2421|095|P|asthma, chronic obstructive pulmonary disease-COPD).||
2421|096|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2421|097|P|can make you more dizzy. Do not drive, use machinery, or do||
2421|098|P|anything that needs alertness until you can do it safely. Limit||
2421|099|P|alcoholic beverages. Talk to your doctor if you are using||
2421|100|P|marijuana (cannabis).||
2421|101|P|   Before having surgery, tell your doctor or dentist about all||
2421|102|P|the products you use (including prescription drugs,||
2421|103|P|nonprescription drugs, and herbal products).||
2421|104|P|   During pregnancy, this medication should be used only when||
2421|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
2421|106|P|    This medication passes into breast milk. Consult your doctor||
2421|107|P|before breastfeeding.||
2421|108|B|||
2421|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2421|110|I|medications work or increase your risk for serious side effects.||
2421|111|I|This document does not contain all possible drug interactions.||
2421|112|I|Keep a list of all the products you use (including||
2421|113|I|prescription/nonprescription drugs and herbal products) and share||
2421|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
2421|115|I|the dosage of any medicines without your doctor's approval.||
2421|116|B|||
2421|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2421|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2421|119|O|poison control center right away. US residents can call||
2421|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2421|121|O|Symptoms of overdose may include: severe dizziness, fainting.||
2421|122|B|||
2421|123|N|NOTES:  Do not share this medication with others.||
2421|124|N|   Lab and/or medical tests (such as blood pressure) may be done||
2421|125|N|while you are using this medication. Keep all medical and lab||
2421|126|N|appointments. Consult your doctor for more details.||
2421|127|B|||
2421|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2421|129|D|If it is near the time of the next dose, skip the missed dose.||
2421|130|D|Use your next dose at the regular time. Do not double the dose to||
2421|131|D|catch up.||
2421|132|B|||
2421|133|R|STORAGE:  Store the unopened blister card in the refrigerator.||
2421|134|R|The unopened blister card may also be stored at room temperature||
2421|135|R|if needed. If the unopened blister card is stored at room||
2421|136|R|temperature, discard after 8 weeks. After opening the blister||
2421|137|R|card, store the unused cartridges at room temperature. Once the||
2421|138|R|blister card is opened, the cartridges expire after 3 days. Keep||
2421|139|R|all medications away from children and pets.||
2421|140|R|   The inhaler device may be stored at room temperature or in the||
2421|141|R|refrigerator. Discard the inhaler device after 7 days of use.||
2421|142|R|   Do not flush medications down the toilet or pour them into a||
2421|143|R|drain unless instructed to do so. Properly discard this product||
2421|144|R|when it is expired or no longer needed. Consult your pharmacist||
2421|145|R|or local waste disposal company.||
2421|146|B|||
2421|147|A|Information last revised August 2025.||
2421|148|A|Copyright(c) 2025 First Databank, Inc.||
2421|149|B|||
2422|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2422|002|Z|does NOT have all possible information about this product. This||
2422|003|Z|information does not assure that this product is safe, effective,||
2422|004|Z|or appropriate for you. This information is not individual||
2422|005|Z|medical advice and does not substitute for the advice of your||
2422|006|Z|health care professional. Always ask your health care||
2422|007|Z|professional for complete information about this product and your||
2422|008|Z|specific health needs.||
2422|009|B|||
2422|010|T|TAPINAROF - TOPICAL||
2422|011|F|(ta-PIN-ar-of)||
2422|012|B|||
2422|013|C|COMMON BRAND NAME(S): VTAMA||
2422|014|B|||
2422|015|U|USES:  This medication is used to treat certain skin conditions||
2422|016|U|(atopic dermatitis, plaque psoriasis). Tapinarof may help lessen||
2422|017|U|the symptoms of these skin conditions (such as redness, itching).||
2422|018|B|||
2422|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2422|020|H|from your pharmacist before you start using tapinarof and each||
2422|021|H|time you get a refill. If you have any questions, ask your doctor||
2422|022|H|or pharmacist.||
2422|023|H|   Wash and dry your hands before applying the medication, then||
2422|024|H|clean and dry the affected area. Apply a thin film of the||
2422|025|H|medication to the affected area and gently rub in as directed by||
2422|026|H|your doctor, usually once daily. Do not apply this medication to||
2422|027|H|normal, healthy skin. Wash your hands after using this medication||
2422|028|H|unless your hands are being treated. If your doctor recommends a||
2422|029|H|moisturizer, apply it after this medication.||
2422|030|H|   This medication is for use on the skin only. Avoid getting||
2422|031|H|this medication in your eyes, mouth, or vagina. If you do get the||
2422|032|H|medication in those areas, flush with plenty of water.||
2422|033|H|   Use this medication regularly to get the most benefit from it.||
2422|034|H|To help you remember, use it at the same time each day.||
2422|035|H|   Do not use large amounts or apply this medication more often||
2422|036|H|than directed or use it for longer than prescribed. Your||
2422|037|H|condition will not improve any faster, and your risk of side||
2422|038|H|effects will increase.||
2422|039|H|   Tell your doctor if your condition does not get better or if||
2422|040|H|it gets worse.||
2422|041|B|||
2422|042|S|SIDE EFFECTS:  Skin irritation/redness or small red bumps on the||
2422|043|S|skin (folliculitis) may occur where the medication is applied. If||
2422|044|S|any of these effects last or get worse, tell your doctor or||
2422|045|S|pharmacist promptly.||
2422|046|S|   Remember that this medication has been prescribed because your||
2422|047|S|doctor has judged that the benefit to you is greater than the||
2422|048|S|risk of side effects. Many people using this medication do not||
2422|049|S|have serious side effects.||
2422|050|S|   Tell your doctor right away if you have any serious side||
2422|051|S|effects, including: signs of infection (such as sore throat that||
2422|052|S|doesn't go away, fever, chills).||
2422|053|S|   A very serious allergic reaction to this drug is rare.||
2422|054|S|However, get medical help right away if you notice any symptoms||
2422|055|S|of a serious allergic reaction, including: rash, itching/swelling||
2422|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2422|057|S|breathing.||
2422|058|S|   This is not a complete list of possible side effects. If you||
2422|059|S|notice other effects not listed above, contact your doctor or||
2422|060|S|pharmacist.||
2422|061|S|   In the US -||
2422|062|S|   Call your doctor for medical advice about side effects. You||
2422|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2422|064|S|www.fda.gov/medwatch.||
2422|065|S|   In Canada - Call your doctor for medical advice about side||
2422|066|S|effects. You may report side effects to Health Canada at||
2422|067|S|1-866-234-2345.||
2422|068|B|||
2422|069|P|PRECAUTIONS:  Before using tapinarof, tell your doctor or||
2422|070|P|pharmacist if you are allergic to it; or if you have any other||
2422|071|P|allergies. This product may contain inactive ingredients, which||
2422|072|P|can cause allergic reactions or other problems. Talk to your||
2422|073|P|pharmacist for more details.||
2422|074|P|   Before using this medication, tell your doctor or pharmacist||
2422|075|P|your medical history.||
2422|076|P|   Before having surgery, tell your doctor or dentist about all||
2422|077|P|the products you use (including prescription drugs,||
2422|078|P|nonprescription drugs, and herbal products).||
2422|079|P|   Children may be at greater risk for infections while using||
2422|080|P|this drug.||
2422|081|P|   During pregnancy, this medication should be used only when||
2422|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
2422|083|P|   It is unknown if this medication passes into breast milk.||
2422|084|P|Consult your doctor before breastfeeding.||
2422|085|B|||
2422|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2422|087|I|medications work or increase your risk for serious side effects.||
2422|088|I|This document does not contain all possible drug interactions.||
2422|089|I|Keep a list of all the products you use (including||
2422|090|I|prescription/nonprescription drugs and herbal products) and share||
2422|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2422|092|I|the dosage of any medicines without your doctor's approval.||
2422|093|B|||
2422|094|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2422|095|O|has overdosed and has serious symptoms such as passing out or||
2422|096|O|trouble breathing, call 911. Otherwise, call a poison control||
2422|097|O|center right away. US residents can call 1-800-222-1222. Canada||
2422|098|O|residents can call 1-844-764-7669.||
2422|099|B|||
2422|100|N|NOTES:  Do not share this medication with others.||
2422|101|N|   This medication has been prescribed for your current condition||
2422|102|N|only. Do not use it later for another skin condition unless your||
2422|103|N|doctor tells you to.||
2422|104|B|||
2422|105|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2422|106|D|If it is near the time of the next dose, skip the missed dose.||
2422|107|D|Use your next dose at the regular time. Do not double the dose to||
2422|108|D|catch up.||
2422|109|B|||
2422|110|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
2422|111|R|medications away from children and pets.||
2422|112|R|   Do not flush medications down the toilet or pour them into a||
2422|113|R|drain unless instructed to do so. Properly discard this product||
2422|114|R|when it is expired or no longer needed. Consult your pharmacist||
2422|115|R|or local waste disposal company.||
2422|116|B|||
2422|117|A|Information last revised April 2025.||
2422|118|A|Copyright(c) 2025 First Databank, Inc.||
2422|119|B|||
2423|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2423|002|Z|does NOT have all possible information about this product. This||
2423|003|Z|information does not assure that this product is safe, effective,||
2423|004|Z|or appropriate for you. This information is not individual||
2423|005|Z|medical advice and does not substitute for the advice of your||
2423|006|Z|health care professional. Always ask your health care||
2423|007|Z|professional for complete information about this product and your||
2423|008|Z|specific health needs.||
2423|009|B|||
2423|010|T|GANAXOLONE - ORAL||
2423|011|F|(gan-AX-oh-lone)||
2423|012|B|||
2423|013|C|COMMON BRAND NAME(S): Ztalmy||
2423|014|B|||
2423|015|U|USES:  This medication is used to treat seizures caused by a||
2423|016|U|certain inherited disease (cyclin-dependent kinase-like 5||
2423|017|U|deficiency disorder-CDD). It is not known exactly how ganaxolone||
2423|018|U|works, but it may affect the action of some nerves that cause||
2423|019|U|seizures.||
2423|020|B|||
2423|021|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2423|022|H|provided by your pharmacist before you start taking ganaxolone||
2423|023|H|and each time you get a refill. If you have any questions, ask||
2423|024|H|your doctor or pharmacist.||
2423|025|H|   Take this medication by mouth with food as directed by your||
2423|026|H|doctor, usually three times daily.||
2423|027|H|   Before use, shake the bottle well for 1 minute. Then let it||
2423|028|H|stand until the foam on top of the suspension is gone (about 1||
2423|029|H|minute). Carefully measure the dose using a special measuring||
2423|030|H|device/spoon. Do not use a household spoon because you may not||
2423|031|H|get the correct dose.||
2423|032|H|   The dosage is based on your medical condition, weight, and||
2423|033|H|response to treatment. To reduce your risk of side effects, your||
2423|034|H|doctor may direct you to start this medication at a low dose and||
2423|035|H|gradually increase your dose. Follow your doctor's instructions||
2423|036|H|carefully.||
2423|037|H|   Use this medication regularly to get the most benefit from it.||
2423|038|H|To help you remember, take it at the same times each day.||
2423|039|H|   Do not stop taking this medication without consulting your||
2423|040|H|doctor. Some conditions may become worse when this drug is||
2423|041|H|suddenly stopped. Your dose may need to be gradually decreased.||
2423|042|H|   Tell your doctor if your condition does not get better or if||
2423|043|H|it gets worse.||
2423|044|B|||
2423|045|S|SIDE EFFECTS:  Drowsiness, tiredness, or fever may occur. If any||
2423|046|S|of these effects last or get worse, tell your doctor or||
2423|047|S|pharmacist promptly.||
2423|048|S|   Remember that this medication has been prescribed because your||
2423|049|S|doctor has judged that the benefit to you is greater than the||
2423|050|S|risk of side effects. Many people using this medication do not||
2423|051|S|have serious side effects.||
2423|052|S|   A small number of people who take anticonvulsants for any||
2423|053|S|condition (such as seizure, bipolar disorder, pain) may||
2423|054|S|experience depression, suicidal thoughts/attempts, or other||
2423|055|S|mental/mood problems. Tell your doctor right away if you or your||
2423|056|S|family/caregiver notice any unusual/sudden changes in your mood,||
2423|057|S|thoughts, or behavior such as signs of depression, suicidal||
2423|058|S|thoughts/attempts, thoughts about harming yourself.||
2423|059|S|   A very serious allergic reaction to this drug is rare.||
2423|060|S|However, get medical help right away if you notice any symptoms||
2423|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2423|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2423|063|S|breathing.||
2423|064|S|   This is not a complete list of possible side effects. If you||
2423|065|S|notice other effects not listed above, contact your doctor or||
2423|066|S|pharmacist.||
2423|067|S|   In the US -||
2423|068|S|   Call your doctor for medical advice about side effects. You||
2423|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2423|070|S|www.fda.gov/medwatch.||
2423|071|S|   In Canada - Call your doctor for medical advice about side||
2423|072|S|effects. You may report side effects to Health Canada at||
2423|073|S|1-866-234-2345.||
2423|074|B|||
2423|075|P|PRECAUTIONS:  Before taking ganaxolone, tell your doctor or||
2423|076|P|pharmacist if you are allergic to it; or if you have any other||
2423|077|P|allergies. This product may contain inactive ingredients, which||
2423|078|P|can cause allergic reactions or other problems. Talk to your||
2423|079|P|pharmacist for more details.||
2423|080|P|   Before using this medication, tell your doctor or pharmacist||
2423|081|P|your medical history, especially of: liver problems, mental/mood||
2423|082|P|disorders (such as confusion, depression, thoughts of suicide),||
2423|083|P|substance use disorder (such as overuse of or addiction to||
2423|084|P|drugs/alcohol).||
2423|085|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
2423|086|P|can make you more drowsy. Do not drive, use machinery, or do||
2423|087|P|anything that needs alertness until you can do it safely. Limit||
2423|088|P|alcoholic beverages. Talk to your doctor if you are using||
2423|089|P|marijuana (cannabis).||
2423|090|P|   Before having surgery, tell your doctor or dentist about all||
2423|091|P|the products you use (including prescription drugs,||
2423|092|P|nonprescription drugs, and herbal products).||
2423|093|P|   During pregnancy, this medication should be used only when||
2423|094|P|clearly needed. However, since untreated seizures are a serious||
2423|095|P|condition that can harm both a pregnant woman and her unborn||
2423|096|P|baby, do not stop taking this medication unless directed by your||
2423|097|P|doctor. If you are planning pregnancy, become pregnant, or think||
2423|098|P|you may be pregnant, discuss with your doctor right away the||
2423|099|P|benefits and risks of using this medication during pregnancy.||
2423|100|P|   This medication passes into breast milk. Consult your doctor||
2423|101|P|before breastfeeding.||
2423|102|B|||
2423|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2423|104|I|medications work or increase your risk for serious side effects.||
2423|105|I|This document does not contain all possible drug interactions.||
2423|106|I|Keep a list of all the products you use (including||
2423|107|I|prescription/nonprescription drugs and herbal products) and share||
2423|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
2423|109|I|the dosage of any medicines without your doctor's approval.||
2423|110|I|   Tell your doctor or pharmacist if you are using other products||
2423|111|I|that cause drowsiness such as opioid pain or cough relievers||
2423|112|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2423|113|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2423|114|I|zolpidem), muscle relaxants (such as carisoprodol,||
2423|115|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2423|116|I|diphenhydramine).||
2423|117|I|   Check the labels on all your medicines (such as allergy or||
2423|118|I|cough-and-cold products) because they may contain ingredients||
2423|119|I|that cause drowsiness. Ask your pharmacist about using those||
2423|120|I|products safely.||
2423|121|B|||
2423|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2423|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2423|124|O|poison control center right away. US residents can call||
2423|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2423|126|B|||
2423|127|N|NOTES:  Do not share this medication with others. Sharing it is||
2423|128|N|against the law.||
2423|129|B|||
2423|130|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2423|131|D|remember. If it is near the time of the next dose, skip the||
2423|132|D|missed dose. Take your next dose at the regular time. Do not||
2423|133|D|double the dose to catch up.||
2423|134|B|||
2423|135|R|STORAGE:  Store the bottle upright at room temperature away from||
2423|136|R|light and moisture. Do not store in the bathroom. Once the bottle||
2423|137|R|is opened, this medication expires after 30 days. Keep all||
2423|138|R|medications away from children and pets.||
2423|139|R|   Do not flush medications down the toilet or pour them into a||
2423|140|R|drain unless instructed to do so. Properly discard this product||
2423|141|R|when it is expired or no longer needed. Consult your pharmacist||
2423|142|R|or local waste disposal company.||
2423|143|B|||
2423|144|M|MEDICAL ALERT:  Your condition can cause complications in a||
2423|145|M|medical emergency. For information about enrolling in MedicAlert,||
2423|146|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2423|147|B|||
2423|148|A|Information last revised September 2024.||
2423|149|A|Copyright(c) 2025 First Databank, Inc.||
2423|150|B|||
2424|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2424|002|Z|does NOT have all possible information about this product. This||
2424|003|Z|information does not assure that this product is safe, effective,||
2424|004|Z|or appropriate for you. This information is not individual||
2424|005|Z|medical advice and does not substitute for the advice of your||
2424|006|Z|health care professional. Always ask your health care||
2424|007|Z|professional for complete information about this product and your||
2424|008|Z|specific health needs.||
2424|009|B|||
2424|010|T|VUTRISIRAN - INJECTION||
2424|011|F|(VUE-tri-SIR-an)||
2424|012|B|||
2424|013|C|COMMON BRAND NAME(S): Amvuttra||
2424|014|B|||
2424|015|U|USES:  Vutrisiran is used to treat a certain type of heart||
2424|016|U|failure or nerve problems due to a certain inherited condition||
2424|017|U|(transthyretin-mediated amyloidosis). This condition causes a||
2424|018|U|protein that your body normally makes (transthyretin-TTR), to||
2424|019|U|change shape and build up in different parts of your body, which||
2424|020|U|can affect the nerves, heart, and stomach/intestines. This||
2424|021|U|medication works by decreasing the buildup of TTR in your body.||
2424|022|U|In people with heart failure, it may help lower the risk of death||
2424|023|U|from heart disease, prevent the worsening of heart failure, and||
2424|024|U|decrease the need to go to a hospital to treat heart failure.||
2424|025|B|||
2424|026|H|HOW TO USE:  This medication is given by injection under the skin||
2424|027|H|by a health care professional. It is injected in the thigh,||
2424|028|H|abdomen, or upper arm as directed by your doctor, usually once||
2424|029|H|every 3 months.||
2424|030|H|   Use this medication regularly to get the most benefit from it.||
2424|031|H|To help you remember, mark your calendar with a reminder.||
2424|032|H|   Tell your doctor if your condition does not get better or if||
2424|033|H|it gets worse.||
2424|034|B|||
2424|035|S|SIDE EFFECTS:  Bruising, redness, itching, or pain at the||
2424|036|S|injection site may occur. Pain in the arm/leg, joint pain or||
2424|037|S|shortness of breath may also occur. If any of these effects last||
2424|038|S|or get worse, tell your doctor or pharmacist promptly.||
2424|039|S|   Remember that this medication has been prescribed because your||
2424|040|S|doctor has judged that the benefit to you is greater than the||
2424|041|S|risk of side effects. Many people using this medication do not||
2424|042|S|have serious side effects.||
2424|043|S|   This medication decreases vitamin A levels in your blood. Ask||
2424|044|S|your doctor about taking a vitamin A supplement. Tell your doctor||
2424|045|S|right away if you develop signs of low vitamin A levels,||
2424|046|S|especially vision changes such as dry eyes, blurred vision, or||
2424|047|S|trouble seeing in dim light (night blindness).||
2424|048|S|   A very serious allergic reaction to this drug is rare.||
2424|049|S|However, get medical help right away if you notice any symptoms||
2424|050|S|of a serious allergic reaction, including: rash, itching/swelling||
2424|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2424|052|S|breathing.||
2424|053|S|   This is not a complete list of possible side effects. If you||
2424|054|S|notice other effects not listed above, contact your doctor or||
2424|055|S|pharmacist.||
2424|056|S|   In the US -||
2424|057|S|   Call your doctor for medical advice about side effects. You||
2424|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2424|059|S|www.fda.gov/medwatch.||
2424|060|S|   In Canada - Call your doctor for medical advice about side||
2424|061|S|effects. You may report side effects to Health Canada at||
2424|062|S|1-866-234-2345.||
2424|063|B|||
2424|064|P|PRECAUTIONS:  Before using vutrisiran, tell your doctor or||
2424|065|P|pharmacist if you are allergic to it; or if you have any other||
2424|066|P|allergies. This product may contain inactive ingredients, which||
2424|067|P|can cause allergic reactions or other problems. Talk to your||
2424|068|P|pharmacist for more details.||
2424|069|P|   Before using this medication, tell your doctor or pharmacist||
2424|070|P|your medical history.||
2424|071|P|   Before having surgery, tell your doctor or dentist about all||
2424|072|P|the products you use (including prescription drugs,||
2424|073|P|nonprescription drugs, and herbal products).||
2424|074|P|   During pregnancy, this medication should be used only when||
2424|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
2424|076|P|   It is unknown if this medication passes into breast milk.||
2424|077|P|Consult your doctor before breastfeeding.||
2424|078|B|||
2424|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2424|080|I|medications work or increase your risk for serious side effects.||
2424|081|I|This document does not contain all possible drug interactions.||
2424|082|I|Keep a list of all the products you use (including||
2424|083|I|prescription/nonprescription drugs and herbal products) and share||
2424|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
2424|085|I|the dosage of any medicines without your doctor's approval.||
2424|086|B|||
2424|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2424|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2424|089|O|poison control center right away. US residents can call||
2424|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2424|091|B|||
2424|092|N|NOTES:  Lab and/or medical tests may be done while you are using||
2424|093|N|this medication. Keep all medical and lab appointments.||
2424|094|B|||
2424|095|D|MISSED DOSE:  It is important to get each dose of this medication||
2424|096|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2424|097|D|right away for a new dosing schedule.||
2424|098|B|||
2424|099|R|STORAGE:  Not applicable. This medication is given in a hospital||
2424|100|R|or clinic or doctor's office and will not be stored at home.||
2424|101|B|||
2424|102|A|Information last revised March 2025.||
2424|103|A|Copyright(c) 2025 First Databank, Inc.||
2424|104|B|||
2425|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2425|002|Z|does NOT have all possible information about this product. This||
2425|003|Z|information does not assure that this product is safe, effective,||
2425|004|Z|or appropriate for you. This information is not individual||
2425|005|Z|medical advice and does not substitute for the advice of your||
2425|006|Z|health care professional. Always ask your health care||
2425|007|Z|professional for complete information about this product and your||
2425|008|Z|specific health needs.||
2425|009|B|||
2425|010|T|RANOLAZINE EXTENDED-RELEASE GRANULES - ORAL||
2425|011|F|(ra-NOE-la-zeen)||
2425|012|B|||
2425|013|C|COMMON BRAND NAME(S): Aspruzyo Sprinkle||
2425|014|B|||
2425|015|U|USES:  Ranolazine is used to treat a certain type of chest pain||
2425|016|U|(chronic angina). It decreases how often you may get chest pain||
2425|017|U|and may help to increase your ability to exercise.||
2425|018|U|   Ranolazine works differently than other drugs for angina, so||
2425|019|U|it can be used with your other angina medications (including||
2425|020|U|nitrates, calcium channel blockers such as amlodipine, beta||
2425|021|U|blockers such as metoprolol). It is thought to work by improving||
2425|022|U|how well the heart uses oxygen so that it can do more work with||
2425|023|U|less oxygen.||
2425|024|B|||
2425|025|V|OTHER USES:  This section contains uses of this drug that are not||
2425|026|V|listed in the approved professional labeling for the drug but||
2425|027|V|that may be prescribed by your health care professional. Use this||
2425|028|V|drug for a condition that is listed in this section only if it||
2425|029|V|has been so prescribed by your health care professional.||
2425|030|V|   This medication may also be used for irregular heartbeat.||
2425|031|B|||
2425|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2425|033|H|from your pharmacist before you start taking ranolazine and each||
2425|034|H|time you get a refill. If you have any questions, ask your doctor||
2425|035|H|or pharmacist.||
2425|036|H|   Take this medication by mouth as directed by your doctor,||
2425|037|H|usually twice daily.||
2425|038|H|   To use this product, open the packet and sprinkle the contents||
2425|039|H|on a tablespoonful of soft food (such as applesauce or yogurt)||
2425|040|H|and eat the mixture right away. Do not crush or chew the mixture||
2425|041|H|or save it for later use. Also, do not drink alcohol or use any||
2425|042|H|product that contains alcohol while taking this medication.||
2425|043|H|Drinking alcohol with this medication or crushing or chewing the||
2425|044|H|granules can release all of the drug at once, increasing the risk||
2425|045|H|of side effects.||
2425|046|H|   If giving through a feeding tube, the contents of the packet||
2425|047|H|should be mixed with water as directed.||
2425|048|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2425|049|H|using this medication unless your doctor or pharmacist says you||
2425|050|H|may do so safely. Grapefruit can increase the chance of side||
2425|051|H|effects with this medicine. Ask your doctor or pharmacist for||
2425|052|H|more details.||
2425|053|H|   The dosage is based on your medical condition, response to||
2425|054|H|treatment, and other medications you may be taking. Be sure to||
2425|055|H|tell your doctor and pharmacist about all the products you use||
2425|056|H|(including prescription drugs, nonprescription drugs, and herbal||
2425|057|H|products).||
2425|058|H|   Do not increase your dose or use this drug more often or for||
2425|059|H|longer than prescribed. Your condition will not improve any||
2425|060|H|faster, and your risk of side effects will increase.||
2425|061|H|   Use this medication regularly to get the most benefit from it.||
2425|062|H|To help you remember, take it at the same times each day. This||
2425|063|H|medication must be taken regularly to be effective. It should not||
2425|064|H|be used to treat angina when it occurs. Use other medications||
2425|065|H|(such as sublingual nitroglycerin) to relieve an angina attack as||
2425|066|H|directed by your doctor. Consult your doctor or pharmacist for||
2425|067|H|details.||
2425|068|H|   Tell your doctor if your condition does not get better or if||
2425|069|H|it gets worse (such as if your chest pain happens more often).||
2425|070|B|||
2425|071|S|SIDE EFFECTS:  Dizziness, headache, lightheadedness, nausea,||
2425|072|S|tiredness, or constipation may occur. If any of these effects||
2425|073|S|last or get worse, tell your doctor or pharmacist promptly.||
2425|074|S|   To reduce the risk of dizziness and lightheadedness, get up||
2425|075|S|slowly when rising from a sitting or lying position.||
2425|076|S|   Remember that this medication has been prescribed because your||
2425|077|S|doctor has judged that the benefit to you is greater than the||
2425|078|S|risk of side effects. Many people using this medication do not||
2425|079|S|have serious side effects.||
2425|080|S|   Tell your doctor right away if you have any serious side||
2425|081|S|effects, including: signs of kidney problems (such as change in||
2425|082|S|the amount of urine).||
2425|083|S|   Get medical help right away if you have any very serious side||
2425|084|S|effects, including: fainting, severe dizziness, fast/irregular||
2425|085|S|heartbeat.||
2425|086|S|   A very serious allergic reaction to this drug is rare.||
2425|087|S|However, get medical help right away if you notice any symptoms||
2425|088|S|of a serious allergic reaction, including: rash, itching/swelling||
2425|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2425|090|S|breathing.||
2425|091|S|   This is not a complete list of possible side effects. If you||
2425|092|S|notice other effects not listed above, contact your doctor or||
2425|093|S|pharmacist.||
2425|094|S|   In the US -||
2425|095|S|   Call your doctor for medical advice about side effects. You||
2425|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2425|097|S|www.fda.gov/medwatch.||
2425|098|S|   In Canada - Call your doctor for medical advice about side||
2425|099|S|effects. You may report side effects to Health Canada at||
2425|100|S|1-866-234-2345.||
2425|101|B|||
2425|102|P|PRECAUTIONS:  Before taking ranolazine, tell your doctor or||
2425|103|P|pharmacist if you are allergic to it; or if you have any other||
2425|104|P|allergies. This product may contain inactive ingredients, which||
2425|105|P|can cause allergic reactions or other problems. Talk to your||
2425|106|P|pharmacist for more details.||
2425|107|P|   Before using this medication, tell your doctor or pharmacist||
2425|108|P|your medical history, especially of: liver problems (such as||
2425|109|P|cirrhosis), kidney problems.||
2425|110|P|   Ranolazine may cause a condition that affects the heart rhythm||
2425|111|P|(QT prolongation). QT prolongation can rarely cause serious||
2425|112|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2425|113|P|as severe dizziness, fainting) that need medical attention right||
2425|114|P|away.||
2425|115|P|   The risk of QT prolongation may be increased if you have||
2425|116|P|certain medical conditions or are taking other drugs that may||
2425|117|P|cause QT prolongation. Before using ranolazine, tell your doctor||
2425|118|P|or pharmacist of all the drugs you take and if you have any of||
2425|119|P|the following conditions: certain heart problems (heart failure,||
2425|120|P|slow heartbeat, QT prolongation in the EKG), family history of||
2425|121|P|certain heart problems (QT prolongation in the EKG, sudden||
2425|122|P|cardiac death).||
2425|123|P|   Low levels of potassium or magnesium in the blood may also||
2425|124|P|increase your risk of QT prolongation. This risk may increase if||
2425|125|P|you use certain drugs (such as diuretics/"water pills") or if you||
2425|126|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2425|127|P|Talk to your doctor about using ranolazine safely.||
2425|128|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2425|129|P|can make you more dizzy. Do not drive, use machinery, or do||
2425|130|P|anything that needs alertness until you can do it safely. Avoid||
2425|131|P|alcoholic beverages. Talk to your doctor if you are using||
2425|132|P|marijuana (cannabis).||
2425|133|P|   Before having surgery, tell your doctor or dentist about all||
2425|134|P|the products you use (including prescription drugs,||
2425|135|P|nonprescription drugs, and herbal products).||
2425|136|P|   Older adults may be more sensitive to the side effects of this||
2425|137|P|drug, especially QT prolongation (see above).||
2425|138|P|   During pregnancy, this medication should be used only when||
2425|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
2425|140|P|   It is unknown if this medication passes into breast milk.||
2425|141|P|Consult your doctor before breastfeeding.||
2425|142|B|||
2425|143|I|DRUG INTERACTIONS:  See also How to Use section.||
2425|144|I|   Drug interactions may change how your medications work or||
2425|145|I|increase your risk for serious side effects. This document does||
2425|146|I|not contain all possible drug interactions. Keep a list of all||
2425|147|I|the products you use (including prescription/nonprescription||
2425|148|I|drugs and herbal products) and share it with your doctor and||
2425|149|I|pharmacist. Do not start, stop, or change the dosage of any||
2425|150|I|medicines without your doctor's approval.||
2425|151|I|   Other medications can affect the removal of ranolazine from||
2425|152|I|your body, which may affect how ranolazine works. Examples||
2425|153|I|include azole antifungals (such as itraconazole, ketoconazole),||
2425|154|I|clarithromycin, cobicistat, nefazodone, HIV protease inhibitors||
2425|155|I|(such as nelfinavir), rifamycins (such as rifabutin, rifampin),||
2425|156|I|ritonavir, drugs used to treat seizures (such as carbamazepine,||
2425|157|I|phenobarbital, phenytoin), St. John's wort, among others.||
2425|158|B|||
2425|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2425|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2425|161|O|poison control center right away. US residents can call||
2425|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2425|163|O|Symptoms of overdose may include: severe dizziness, fainting,||
2425|164|O|fast/slow/irregular heartbeat, mental/mood changes (such as||
2425|165|O|confusion, hallucinations), seizures, unsteadiness.||
2425|166|B|||
2425|167|N|NOTES:  Do not share this medication with others.||
2425|168|N|   Lab and/or medical tests (such as kidney function) may be done||
2425|169|N|while you are taking this medication. Keep all medical and lab||
2425|170|N|appointments. Consult your doctor for more details.||
2425|171|B|||
2425|172|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2425|173|D|next dose at the regular time. Do not double the dose to catch||
2425|174|D|up.||
2425|175|B|||
2425|176|R|STORAGE:  Store at room temperature away from light and moisture.||
2425|177|R|Do not store in the bathroom. Keep all medications away from||
2425|178|R|children and pets.||
2425|179|R|   Do not flush medications down the toilet or pour them into a||
2425|180|R|drain unless instructed to do so. Properly discard this product||
2425|181|R|when it is expired or no longer needed. Consult your pharmacist||
2425|182|R|or local waste disposal company.||
2425|183|B|||
2425|184|M|MEDICAL ALERT:  Your condition can cause complications in a||
2425|185|M|medical emergency. For information about enrolling in MedicAlert,||
2425|186|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2425|187|B|||
2425|188|A|Information last revised April 2025.||
2425|189|A|Copyright(c) 2025 First Databank, Inc.||
2425|190|B|||
2426|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2426|002|Z|does NOT have all possible information about this product. This||
2426|003|Z|information does not assure that this product is safe, effective,||
2426|004|Z|or appropriate for you. This information is not individual||
2426|005|Z|medical advice and does not substitute for the advice of your||
2426|006|Z|health care professional. Always ask your health care||
2426|007|Z|professional for complete information about this product and your||
2426|008|Z|specific health needs.||
2426|009|B|||
2426|010|T|SIROLIMUS - TOPICAL||
2426|011|F|(sir-OH-li-mus)||
2426|012|B|||
2426|013|C|COMMON BRAND NAME(S): Hyftor||
2426|014|B|||
2426|015|U|USES:  Sirolimus is used to treat clusters of bumps on the face||
2426|016|U|(facial angiofibroma) in people with a certain genetic disorder||
2426|017|U|(tuberous sclerosis). This medication belongs to a class of drugs||
2426|018|U|known as immunosuppressants. It works by weakening your body's||
2426|019|U|defense system (immune system).||
2426|020|B|||
2426|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2426|022|H|from your pharmacist before you start using sirolimus and each||
2426|023|H|time you get a refill. If you have any questions, ask your doctor||
2426|024|H|or pharmacist.||
2426|025|H|   This medication is for use on the skin only. Avoid getting||
2426|026|H|this medication in your eyes or on the inside of your mouth or||
2426|027|H|vagina.||
2426|028|H|   Wash and dry your hands before applying the medication, then||
2426|029|H|clean and dry the affected area. Apply a thin film of the||
2426|030|H|medication to the affected area and gently rub in as directed by||
2426|031|H|your doctor, usually twice daily (once in the morning and once at||
2426|032|H|bedtime). Do not cover, bandage, or wrap the area unless directed||
2426|033|H|to do so by your doctor.||
2426|034|H|   The dosage is based on your medical condition, age, and||
2426|035|H|response to treatment.||
2426|036|H|   Use this medication regularly to get the most benefit from it.||
2426|037|H|To help you remember, use it at the same times each day.||
2426|038|H|   Do not increase your dose or use this drug more often or for||
2426|039|H|longer than prescribed. Your condition will not improve any||
2426|040|H|faster, and your risk of side effects will increase.||
2426|041|H|   Tell your doctor if your condition does not get better after||
2426|042|H|12 weeks of using this medication or if your condition gets worse||
2426|043|H|at any time.||
2426|044|B|||
2426|045|S|SIDE EFFECTS:  Dry skin, acne, eye redness, or skin irritation||
2426|046|S|may occur. If any of these effects last or get worse, tell your||
2426|047|S|doctor or pharmacist promptly.||
2426|048|S|   Remember that this medication has been prescribed because your||
2426|049|S|doctor has judged that the benefit to you is greater than the||
2426|050|S|risk of side effects. Many people using this medication do not||
2426|051|S|have serious side effects.||
2426|052|S|   Tell your doctor right away if you have any serious side||
2426|053|S|effects, including: signs of infection (such as sore throat that||
2426|054|S|doesn't go away, fever, chills), unusual skin changes, change in||
2426|055|S|the appearance/size of moles, swollen lymph nodes, night sweats,||
2426|056|S|unexplained weight loss.||
2426|057|S|   Get medical help right away if you have any very serious side||
2426|058|S|effects, including: chest pain, shortness of breath.||
2426|059|S|   A very serious allergic reaction to this drug is rare.||
2426|060|S|However, get medical help right away if you notice any symptoms||
2426|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2426|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2426|063|S|breathing.||
2426|064|S|   This is not a complete list of possible side effects. If you||
2426|065|S|notice other effects not listed above, contact your doctor or||
2426|066|S|pharmacist.||
2426|067|S|   In the US -||
2426|068|S|   Call your doctor for medical advice about side effects. You||
2426|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2426|070|S|www.fda.gov/medwatch.||
2426|071|S|   In Canada - Call your doctor for medical advice about side||
2426|072|S|effects. You may report side effects to Health Canada at||
2426|073|S|1-866-234-2345.||
2426|074|B|||
2426|075|P|PRECAUTIONS:  Before using sirolimus, tell your doctor or||
2426|076|P|pharmacist if you are allergic to it; or to temsirolimus; or if||
2426|077|P|you have any other allergies. This product may contain inactive||
2426|078|P|ingredients, which can cause allergic reactions or other||
2426|079|P|problems. Talk to your pharmacist for more details.||
2426|080|P|   Before using this medication, tell your doctor or pharmacist||
2426|081|P|your medical history, especially of: high||
2426|082|P|cholesterol/triglyceride levels, cancer, any recent/current||
2426|083|P|infections.||
2426|084|P|   Sirolimus can make you more likely to get infections or may||
2426|085|P|make current infections worse. Stay away from anyone who has an||
2426|086|P|infection that may easily spread (such as chickenpox, COVID-19,||
2426|087|P|measles, flu). Talk to your doctor if you have been exposed to an||
2426|088|P|infection or for more details.||
2426|089|P|   Tell your health care professional that you are using||
2426|090|P|sirolimus before having any immunizations/vaccinations. Avoid||
2426|091|P|contact with people who have recently received live vaccines||
2426|092|P|(such as flu vaccine inhaled through the nose).||
2426|093|P|   This medication may increase your risk of developing skin||
2426|094|P|cancer. Limit your time in the sun. Avoid tanning booths and||
2426|095|P|sunlamps. Use sunscreen and wear protective clothing when||
2426|096|P|outdoors.||
2426|097|P|   Before having surgery, tell your doctor or dentist about all||
2426|098|P|the products you use (including prescription drugs,||
2426|099|P|nonprescription drugs, and herbal products).||
2426|100|P|   This medication may affect fertility in males. Ask your doctor||
2426|101|P|for more details.||
2426|102|P|   Tell your doctor if you are pregnant or plan to become||
2426|103|P|pregnant. You should not become pregnant while using sirolimus.||
2426|104|P|Sirolimus may harm an unborn baby. Ask about reliable forms of||
2426|105|P|birth control while using this medication and for 12 weeks after||
2426|106|P|the last dose. If you become pregnant, talk to your doctor right||
2426|107|P|away about the risks and benefits of this medication.||
2426|108|P|   This medication may pass into breast milk and may have||
2426|109|P|undesirable effects on a nursing infant. Breastfeeding is not||
2426|110|P|recommended while using this medication. Consult your doctor||
2426|111|P|before breastfeeding.||
2426|112|B|||
2426|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2426|114|I|medications work or increase your risk for serious side effects.||
2426|115|I|This document does not contain all possible drug interactions.||
2426|116|I|Keep a list of all the products you use (including||
2426|117|I|prescription/nonprescription drugs and herbal products) and share||
2426|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
2426|119|I|the dosage of any medicines without your doctor's approval.||
2426|120|B|||
2426|121|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2426|122|O|has overdosed and has serious symptoms such as passing out or||
2426|123|O|trouble breathing, call 911. Otherwise, call a poison control||
2426|124|O|center right away. US residents can call 1-800-222-1222. Canada||
2426|125|O|residents can call 1-844-764-7669.||
2426|126|B|||
2426|127|N|NOTES:  Do not share this medication with others.||
2426|128|N|   Lab and/or medical tests (such as cholesterol/triglyceride||
2426|129|N|levels) may be done while you are using this medication. Keep all||
2426|130|N|medical and lab appointments. Consult your doctor for more||
2426|131|N|details.||
2426|132|B|||
2426|133|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2426|134|D|If it is near the time of the next dose, skip the missed dose.||
2426|135|D|Use your next dose at the regular time. Do not double the dose to||
2426|136|D|catch up.||
2426|137|B|||
2426|138|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
2426|139|R|medications away from children and pets.||
2426|140|R|   Do not flush medications down the toilet or pour them into a||
2426|141|R|drain unless instructed to do so. Properly discard this product||
2426|142|R|when it is expired or no longer needed. Consult your pharmacist||
2426|143|R|or local waste disposal company.||
2426|144|B|||
2426|145|A|Information last revised April 2025.||
2426|146|A|Copyright(c) 2025 First Databank, Inc.||
2426|147|B|||
2427|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2427|002|Z|does NOT have all possible information about this product. This||
2427|003|Z|information does not assure that this product is safe, effective,||
2427|004|Z|or appropriate for you. This information is not individual||
2427|005|Z|medical advice and does not substitute for the advice of your||
2427|006|Z|health care professional. Always ask your health care||
2427|007|Z|professional for complete information about this product and your||
2427|008|Z|specific health needs.||
2427|009|B|||
2427|010|T|OTESECONAZOLE - ORAL||
2427|011|F|(oh-TES-e-KON-a-zole)||
2427|012|B|||
2427|013|C|COMMON BRAND NAME(S): Vivjoa||
2427|014|B|||
2427|015|U|USES:  Oteseconazole is used to reduce the risk of vaginal yeast||
2427|016|U|infections that keep coming back (recurrent vulvovaginal||
2427|017|U|candidiasis-RVVC). It works by stopping the growth of common||
2427|018|U|types of vaginal yeast (fungus). This medication belongs to a||
2427|019|U|class of drugs known as azole antifungals.||
2427|020|B|||
2427|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2427|022|H|from your pharmacist before you start taking oteseconazole and||
2427|023|H|each time you get a refill. If you have any questions, ask your||
2427|024|H|doctor or pharmacist.||
2427|025|H|   Take this medication by mouth with food exactly as directed by||
2427|026|H|your doctor. Swallow the capsules whole. Do not crush, chew,||
2427|027|H|dissolve, or open the capsules. The dosage and treatment schedule||
2427|028|H|are based on whether this medication has been prescribed to be||
2427|029|H|taken alone, or whether it has been prescribed to be taken with||
2427|030|H|another antifungal medication (fluconazole). Carefully follow||
2427|031|H|your doctor's directions.||
2427|032|H|   If your doctor has prescribed this medication to be taken||
2427|033|H|alone, it is usually taken for 2 days in a row. Then, starting on||
2427|034|H|day 14 after the first dose, take it once a week (every 7 days)||
2427|035|H|for 11 weeks.||
2427|036|H|   If your doctor has prescribed this medication to be taken with||
2427|037|H|fluconazole, first take fluconazole as directed by your doctor,||
2427|038|H|usually on days 1, 4, and 7. After that, you will stop taking||
2427|039|H|fluconazole. On day 14 after you started taking fluconazole,||
2427|040|H|start taking oteseconazole. Take oteseconazole every day for 7||
2427|041|H|days. Starting on day 28, take oteseconazole once a week (every 7||
2427|042|H|days) for 11 weeks.||
2427|043|H|   Take this medication regularly to get the most benefit from||
2427|044|H|it. To help you remember, mark your calendar with a reminder.||
2427|045|H|   Tell your doctor if you develop symptoms of a vaginal yeast||
2427|046|H|infection (such as vaginal pain, itching, thick/white discharge).||
2427|047|B|||
2427|048|S|SIDE EFFECTS:  Headache or nausea may occur. If either of these||
2427|049|S|effects lasts or gets worse, tell your doctor or pharmacist||
2427|050|S|promptly.||
2427|051|S|   Remember that this medication has been prescribed because your||
2427|052|S|doctor has judged that the benefit to you is greater than the||
2427|053|S|risk of side effects. Many people using this medication do not||
2427|054|S|have serious side effects.||
2427|055|S|   A very serious allergic reaction to this drug is rare.||
2427|056|S|However, get medical help right away if you notice any symptoms||
2427|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2427|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2427|059|S|breathing.||
2427|060|S|   This is not a complete list of possible side effects. If you||
2427|061|S|notice other effects not listed above, contact your doctor or||
2427|062|S|pharmacist.||
2427|063|S|   In the US -||
2427|064|S|   Call your doctor for medical advice about side effects. You||
2427|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2427|066|S|www.fda.gov/medwatch.||
2427|067|S|   In Canada - Call your doctor for medical advice about side||
2427|068|S|effects. You may report side effects to Health Canada at||
2427|069|S|1-866-234-2345.||
2427|070|B|||
2427|071|P|PRECAUTIONS:  Before taking oteseconazole, tell your doctor or||
2427|072|P|pharmacist if you are allergic to it; or if you have any other||
2427|073|P|allergies. This product may contain inactive ingredients, which||
2427|074|P|can cause allergic reactions or other problems. Talk to your||
2427|075|P|pharmacist for more details.||
2427|076|P|   Before using this medication, tell your doctor or pharmacist||
2427|077|P|your medical history, especially of: kidney disease, liver||
2427|078|P|disease.||
2427|079|P|   Before having surgery, tell your doctor or dentist about all||
2427|080|P|the products you use (including prescription drugs,||
2427|081|P|nonprescription drugs, and herbal products).||
2427|082|P|   This medication must not be used if you are pregnant, able to||
2427|083|P|become pregnant, or plan to become pregnant. You should not||
2427|084|P|become pregnant while using oteseconazole. Oteseconazole may harm||
2427|085|P|an unborn baby. If you become pregnant or think you may be||
2427|086|P|pregnant, tell your doctor right away.||
2427|087|P|   It is unknown if this medication passes into breast milk.||
2427|088|P|Breastfeeding is not recommended while using this medication.||
2427|089|P|Consult your doctor before breastfeeding.||
2427|090|B|||
2427|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2427|092|I|medications work or increase your risk for serious side effects.||
2427|093|I|This document does not contain all possible drug interactions.||
2427|094|I|Keep a list of all the products you use (including||
2427|095|I|prescription/nonprescription drugs and herbal products) and share||
2427|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
2427|097|I|the dosage of any medicines without your doctor's approval.||
2427|098|B|||
2427|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2427|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2427|101|O|poison control center right away. US residents can call||
2427|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2427|103|B|||
2427|104|N|NOTES:  Do not share this medication with others.||
2427|105|B|||
2427|106|D|MISSED DOSE:  It is important to take each dose of this||
2427|107|D|medication as scheduled. If you miss a dose, ask your doctor or||
2427|108|D|pharmacist right away for a new dosing schedule.||
2427|109|B|||
2427|110|R|STORAGE:  Store at room temperature away from light and moisture.||
2427|111|R|Do not store in the bathroom. Keep all medications away from||
2427|112|R|children and pets.||
2427|113|R|   Do not flush medications down the toilet or pour them into a||
2427|114|R|drain unless instructed to do so. Properly discard this product||
2427|115|R|when it is expired or no longer needed. Consult your pharmacist||
2427|116|R|or local waste disposal company.||
2427|117|B|||
2427|118|A|Information last revised October 2024.||
2427|119|A|Copyright(c) 2025 First Databank, Inc.||
2427|120|B|||
2428|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2428|002|Z|does NOT have all possible information about this product. This||
2428|003|Z|information does not assure that this product is safe, effective,||
2428|004|Z|or appropriate for you. This information is not individual||
2428|005|Z|medical advice and does not substitute for the advice of your||
2428|006|Z|health care professional. Always ask your health care||
2428|007|Z|professional for complete information about this product and your||
2428|008|Z|specific health needs.||
2428|009|B|||
2428|010|T|AMPHETAMINE EXTENDED-RELEASE TABLET - ORAL||
2428|011|F|(am-FET-a-meen)||
2428|012|B|||
2428|013|C|COMMON BRAND NAME(S):  Dyanavel XR||
2428|014|B|||
2428|015|W|WARNING:  Misuse or abuse of amphetamines may cause serious||
2428|016|W|(possibly fatal) heart and blood pressure problems.||
2428|017|W|Amphetamine-type medications can be habit-forming. Use only as||
2428|018|W|directed. If you use this drug for a long time, you may become||
2428|019|W|dependent on it and may have withdrawal symptoms after stopping||
2428|020|W|the drug. Consult your doctor or pharmacist for more details. See||
2428|021|W|also How to Use section.||
2428|022|B|||
2428|023|U|USES:  This medication is used to treat attention deficit||
2428|024|U|hyperactivity disorder - ADHD. It works by changing the amounts||
2428|025|U|of certain natural substances in the brain. Amphetamine belongs||
2428|026|U|to a class of drugs known as stimulants. It can help increase||
2428|027|U|your ability to pay attention, stay focused on an activity, and||
2428|028|U|control behavior problems. It may also help you to organize your||
2428|029|U|tasks and improve listening skills.||
2428|030|B|||
2428|031|V|OTHER USES:  This section contains uses of this drug that are not||
2428|032|V|listed in the approved professional labeling for the drug but||
2428|033|V|that may be prescribed by your health care professional. Use this||
2428|034|V|drug for a condition that is listed in this section only if it||
2428|035|V|has been so prescribed by your health care professional.||
2428|036|V|   This drug may also be used for a certain sleeping disorder||
2428|037|V|(narcolepsy). It should not be used to treat tiredness or to hold||
2428|038|V|off sleep in people who do not have a sleep disorder.||
2428|039|B|||
2428|040|H|HOW TO USE:  Read the Medication Guide provided by your||
2428|041|H|pharmacist before you start taking amphetamine and each time you||
2428|042|H|get a refill. If you have any questions, ask your doctor or||
2428|043|H|pharmacist.||
2428|044|H|   There are different brands and forms of this medication||
2428|045|H|available. Not all have the same effects. Do not change brands or||
2428|046|H|forms without consulting your doctor or pharmacist.||
2428|047|H|   Take this medication by mouth with or without food as directed||
2428|048|H|by your doctor, usually once daily in the morning. The tablet(s)||
2428|049|H|may be chewed or swallowed whole. Taking this medication late in||
2428|050|H|the day may cause trouble sleeping (insomnia).||
2428|051|H|   The dosage is based on your medical condition and response to||
2428|052|H|treatment. To reduce your risk of side effects, your doctor may||
2428|053|H|direct you to start this medication at a low dose and gradually||
2428|054|H|increase your dose. Follow your doctor's instructions carefully.||
2428|055|H|   Use this medication regularly to get the most benefit from it.||
2428|056|H|To help you remember, take it at the same time each day.||
2428|057|H|   During treatment, your doctor may sometimes stop the||
2428|058|H|medication for a short time to see if the medication is still||
2428|059|H|needed.||
2428|060|H|   Do not increase your dose or use this drug more often or for||
2428|061|H|longer than prescribed. Your condition will not improve any||
2428|062|H|faster, and your risk of side effects will increase.||
2428|063|H|   If you suddenly stop using this medication, you may have||
2428|064|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
2428|065|H|mental/mood changes like depression). To help prevent withdrawal,||
2428|066|H|your doctor may lower your dose slowly. Withdrawal is more likely||
2428|067|H|if you have used this medication for a long time or in high||
2428|068|H|doses. Tell your doctor or pharmacist right away if you have||
2428|069|H|withdrawal.||
2428|070|H|   When this medication is used for a long time, it may not work||
2428|071|H|as well. Talk with your doctor if this medication stops working||
2428|072|H|well.||
2428|073|H|   Though it helps many people, this medication may sometimes||
2428|074|H|cause addiction. This risk may be higher if you have a substance||
2428|075|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2428|076|H|Take this medication exactly as prescribed to lower the risk of||
2428|077|H|addiction. Ask your doctor or pharmacist for more details.||
2428|078|H|   Tell your doctor if you do not get better or if you get worse.||
2428|079|B|||
2428|080|S|SIDE EFFECTS:  Loss of appetite, weight loss, dry mouth, stomach||
2428|081|S|upset/pain, nausea/vomiting, dizziness, headache, diarrhea,||
2428|082|S|fever, nervousness, or trouble sleeping may occur. If any of||
2428|083|S|these effects last or get worse, tell your doctor or pharmacist||
2428|084|S|promptly.||
2428|085|S|   Remember that this medication has been prescribed because your||
2428|086|S|doctor has judged that the benefit to you is greater than the||
2428|087|S|risk of side effects. Many people using this medication do not||
2428|088|S|have serious side effects.||
2428|089|S|   This medication may raise your blood pressure. Check your||
2428|090|S|blood pressure regularly and tell your doctor if the results are||
2428|091|S|high.||
2428|092|S|   Tell your doctor right away if you have any serious side||
2428|093|S|effects, including: signs of blood flow problems in the fingers||
2428|094|S|or toes (such as coldness, numbness, pain, or skin color||
2428|095|S|changes), unusual wounds on the fingers or toes,||
2428|096|S|mental/mood/behavior changes (such as agitation, aggression, mood||
2428|097|S|swings, depression, abnormal thoughts, thoughts of suicide),||
2428|098|S|uncontrolled movements (such as twitching, shaking), outbursts of||
2428|099|S|words/sounds that are hard to control, vision changes (such as||
2428|100|S|blurred vision), change in sexual ability/desire,||
2428|101|S|frequent/prolonged erections (in males).||
2428|102|S|   Get medical help right away if you have any very serious side||
2428|103|S|effects, including: fainting, seizures, severe headache,||
2428|104|S|fast/pounding/irregular heartbeat, symptoms of a heart attack||
2428|105|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
2428|106|S|sweating), symptoms of a stroke (such as weakness on one side of||
2428|107|S|the body, trouble speaking, sudden vision changes, confusion).||
2428|108|S|   This medication may increase serotonin and rarely cause a very||
2428|109|S|serious condition called serotonin syndrome/toxicity. The risk||
2428|110|S|increases if you are also taking other drugs that increase||
2428|111|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2428|112|S|take (see Drug Interactions section). Get medical help right away||
2428|113|S|if you develop some of the following symptoms: fast heartbeat,||
2428|114|S|hallucinations, loss of coordination, severe dizziness, severe||
2428|115|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2428|116|S|unusual agitation/restlessness.||
2428|117|S|   A very serious allergic reaction to this drug is rare.||
2428|118|S|However, get medical help right away if you notice any symptoms||
2428|119|S|of a serious allergic reaction, including: rash, itching/swelling||
2428|120|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2428|121|S|breathing.||
2428|122|S|   This is not a complete list of possible side effects. If you||
2428|123|S|notice other effects not listed above, contact your doctor or||
2428|124|S|pharmacist.||
2428|125|S|   In the US -||
2428|126|S|   Call your doctor for medical advice about side effects. You||
2428|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2428|128|S|www.fda.gov/medwatch.||
2428|129|S|   In Canada - Call your doctor for medical advice about side||
2428|130|S|effects. You may report side effects to Health Canada at||
2428|131|S|1-866-234-2345.||
2428|132|B|||
2428|133|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2428|134|P|pharmacist if you are allergic to it; or to other sympathomimetic||
2428|135|P|drugs (such as lisdexamfetamine, dextroamphetamine); or if you||
2428|136|P|have any other allergies. This product may contain inactive||
2428|137|P|ingredients, which can cause allergic reactions or other||
2428|138|P|problems. Talk to your pharmacist for more details.||
2428|139|P|   Before using this medication, tell your doctor or pharmacist||
2428|140|P|your medical history, especially of: high blood pressure, stroke,||
2428|141|P|personal or family history of heart problems (such as irregular||
2428|142|P|heartbeat, heart attack, heart failure, heart valve problem),||
2428|143|P|blood circulation problems (such as Raynaud's disease), glaucoma,||
2428|144|P|personal or family history of a substance use disorder (such as||
2428|145|P|overuse of or addiction to drugs/alcohol), personal or family||
2428|146|P|history of mental/mood disorders (such as bipolar disorder,||
2428|147|P|depression, psychosis, suicidal thoughts), personal or family||
2428|148|P|history of uncontrolled muscle movements (such as motor tics,||
2428|149|P|Tourette's syndrome), overactive thyroid (hyperthyroidism),||
2428|150|P|seizures.||
2428|151|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2428|152|P|can make you more dizzy. Do not drive, use machinery, or do||
2428|153|P|anything that needs alertness until you can do it safely. Avoid||
2428|154|P|alcoholic beverages. Talk to your doctor if you are using||
2428|155|P|marijuana (cannabis).||
2428|156|P|   Before having surgery, tell your doctor or dentist about all||
2428|157|P|the products you use (including prescription drugs,||
2428|158|P|nonprescription drugs, and herbal products).||
2428|159|P|   Children (especially those younger than 6) may be more||
2428|160|P|sensitive to the side effects of this drug, especially weight||
2428|161|P|loss. This medication may slow down a child's growth. The doctor||
2428|162|P|may recommend temporarily stopping the medication from time to||
2428|163|P|time to reduce this risk. Monitor your child's weight and height.||
2428|164|P|Consult your doctor or pharmacist for more details.||
2428|165|P|   Older adults may be more sensitive to the side effects of this||
2428|166|P|drug, especially chest pain, trouble sleeping, or weight loss.||
2428|167|P|   During pregnancy, this medication should be used only when||
2428|168|P|clearly needed. Discuss the risks and benefits with your doctor.||
2428|169|P|Infants born to mothers who are dependent on this medication may||
2428|170|P|be born too soon (premature) and have low birth weight. They may||
2428|171|P|also have withdrawal symptoms. Tell your doctor right away if you||
2428|172|P|notice possible mood changes, agitation, or unusual tiredness in||
2428|173|P|your newborn.||
2428|174|P|   This medication passes into breast milk and may have||
2428|175|P|undesirable effects on a nursing infant. Breastfeeding is not||
2428|176|P|recommended while using this medication. Consult your doctor||
2428|177|P|before breastfeeding.||
2428|178|B|||
2428|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2428|180|I|medications work or increase your risk for serious side effects.||
2428|181|I|This document does not contain all possible drug interactions.||
2428|182|I|Keep a list of all the products you use (including||
2428|183|I|prescription/nonprescription drugs and herbal products) and share||
2428|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
2428|185|I|the dosage of any medicines without your doctor's approval.||
2428|186|I|   Taking MAO inhibitors with this medication may cause a serious||
2428|187|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2428|188|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2428|189|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2428|190|I|selegiline, tranylcypromine) during treatment with this||
2428|191|I|medication. Most MAO inhibitors should also not be taken for two||
2428|192|I|weeks before treatment with this medication. Ask your doctor when||
2428|193|I|to start or stop taking this medication.||
2428|194|I|   Some products have ingredients that could raise your heart||
2428|195|I|rate or blood pressure. Tell your pharmacist what products you||
2428|196|I|are using, and ask how to use them safely (especially||
2428|197|I|cough-and-cold products or diet aids).||
2428|198|I|   The risk of serotonin syndrome/toxicity increases if you are||
2428|199|I|also taking other drugs that increase serotonin. Examples include||
2428|200|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
2428|201|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2428|202|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2428|203|I|serotonin syndrome/toxicity may be more likely when you start or||
2428|204|I|increase the dose of these drugs.||
2428|205|I|   Amphetamine is very similar to dextroamphetamine and||
2428|206|I|lisdexamfetamine. Do not use medications containing||
2428|207|I|dextroamphetamine or lisdexamfetamine while using amphetamine.||
2428|208|I|   This medication may interfere with certain medical/lab tests||
2428|209|I|(such as blood and urine steroid levels, brain scan for||
2428|210|I|Parkinson's disease), possibly causing false test results. Make||
2428|211|I|sure lab personnel and all your doctors know you use this drug.||
2428|212|B|||
2428|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2428|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2428|215|O|poison control center right away. US residents can call||
2428|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2428|217|O|Symptoms of overdose may include: severe mental/mood changes,||
2428|218|O|seizures, severe headache, severe restlessness, fast breathing.||
2428|219|B|||
2428|220|N|NOTES:  Do not share this medication with others. Sharing it is||
2428|221|N|against the law.||
2428|222|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
2428|223|N|growth monitoring in children) may be done while you are taking||
2428|224|N|this medication. Keep all medical and lab appointments. Consult||
2428|225|N|your doctor for more details.||
2428|226|B|||
2428|227|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
2428|228|D|in the morning hours. If it is after noon or near the time of the||
2428|229|D|next dose, skip the missed dose. Take your next dose at the||
2428|230|D|regular time. Do not double the dose to catch up.||
2428|231|B|||
2428|232|R|STORAGE:  Store at room temperature away from light and moisture.||
2428|233|R|Do not store in the bathroom. Keep all medications away from||
2428|234|R|children and pets.||
2428|235|R|   Do not flush medications down the toilet or pour them into a||
2428|236|R|drain unless instructed to do so. Properly discard this product||
2428|237|R|when it is expired or no longer needed. Consult your pharmacist||
2428|238|R|or local waste disposal company.||
2428|239|B|||
2428|240|A|Information last revised July 2025.||
2428|241|A|Copyright(c) 2025 First Databank, Inc.||
2428|242|B|||
2429|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2429|002|Z|does NOT have all possible information about this product. This||
2429|003|Z|information does not assure that this product is safe, effective,||
2429|004|Z|or appropriate for you. This information is not individual||
2429|005|Z|medical advice and does not substitute for the advice of your||
2429|006|Z|health care professional. Always ask your health care||
2429|007|Z|professional for complete information about this product and your||
2429|008|Z|specific health needs.||
2429|009|B|||
2429|010|T|DEQUALINIUM TABLET - VAGINAL||
2429|011|B|||
2429|012|U|USES:  Dequalinium is used to treat a certain type of vaginal||
2429|013|U|infection (bacterial vaginosis). This medication is an antiseptic||
2429|014|U|that works by stopping the growth of bacteria.||
2429|015|U|   This medication should not be used by people who have not had||
2429|016|U|their first menstrual period.||
2429|017|B|||
2429|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2429|019|H|from your pharmacist before you start using dequalinium and each||
2429|020|H|time you get a refill. If you have any questions, ask your doctor||
2429|021|H|or pharmacist.||
2429|022|H|   This product is for vaginal use only. Wash your hands before||
2429|023|H|and after use. You should not use this medication during your||
2429|024|H|period. Doing so may make it work less well. Start treatment at||
2429|025|H|least 6 days before your next menstrual period or after your||
2429|026|H|period ends. If you get your period while you are already using||
2429|027|H|this medication, stop using it until your period ends. Then,||
2429|028|H|finish the remaining doses after your period ends.||
2429|029|H|   Use this medication as directed by your doctor, usually once||
2429|030|H|daily at bedtime for 6 nights. Continue to use this medication||
2429|031|H|for the full time prescribed, even if symptoms disappear after a||
2429|032|H|few days. Stopping the medication too early may result in a||
2429|033|H|return of the infection.||
2429|034|H|   You may use either the applicator or your finger to insert the||
2429|035|H|tablet. If you are using the applicator, follow the package||
2429|036|H|instructions for how to place the tablet in the applicator. Lie||
2429|037|H|on your back with your legs slightly bent. Gently insert the||
2429|038|H|tablet into the vagina as far as it will comfortably go. If you||
2429|039|H|are using the applicator, gently press the plunger to release the||
2429|040|H|tablet into your vagina. Remove the applicator from your vagina.||
2429|041|H|After each use, clean the applicator with warm water and||
2429|042|H|fragrance-free soap. The applicator should not be shared with||
2429|043|H|others. Throw away the applicator after completing the full||
2429|044|H|treatment.||
2429|045|H|   If your vagina is dry, the tablet may not dissolve and may||
2429|046|H|come out of your vagina in one piece. In this case, add a drop of||
2429|047|H|water to the tablet before inserting. If the tablet is||
2429|048|H|accidentally split, insert both halves of the tablet one after||
2429|049|H|the other, or both at once, if possible.||
2429|050|H|   Do not have vaginal intercourse or use products that go inside||
2429|051|H|your vagina while using this medication. Some examples include:||
2429|052|H|condoms, spermicides, douches, tampons, or menstrual cups. These||
2429|053|H|products may make this medication work less well. Unscented||
2429|054|H|sanitary pads may be used to protect your clothing from leakage||
2429|055|H|of the medication.||
2429|056|H|   Tell your doctor if your condition lasts, gets worse, or||
2429|057|H|returns after treatment.||
2429|058|B|||
2429|059|S|SIDE EFFECTS:  Vaginal itching, irritation, or a change in||
2429|060|S|discharge may occur. If any of these effects last or get worse,||
2429|061|S|tell your doctor or pharmacist promptly. These symptoms could||
2429|062|S|also be due to a new vaginal infection (such as a yeast/fungal||
2429|063|S|infection) and require other treatment.||
2429|064|S|   Remember that this medication has been prescribed because your||
2429|065|S|doctor has judged that the benefit to you is greater than the||
2429|066|S|risk of side effects. Many people using this medication do not||
2429|067|S|have serious side effects.||
2429|068|S|   Tell your doctor right away if you have any serious side||
2429|069|S|effects, including: vaginal sores (ulcers), abnormal vaginal||
2429|070|S|bleeding.||
2429|071|S|   A very serious allergic reaction to this drug is rare.||
2429|072|S|However, get medical help right away if you notice any symptoms||
2429|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2429|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2429|075|S|breathing.||
2429|076|S|   This is not a complete list of possible side effects. If you||
2429|077|S|notice other effects not listed above, contact your doctor or||
2429|078|S|pharmacist.||
2429|079|S|   In the US -||
2429|080|S|   Call your doctor for medical advice about side effects. You||
2429|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2429|082|S|www.fda.gov/medwatch.||
2429|083|S|   In Canada - Call your doctor for medical advice about side||
2429|084|S|effects. You may report side effects to Health Canada at||
2429|085|S|1-866-234-2345.||
2429|086|B|||
2429|087|P|PRECAUTIONS:  Before using dequalinium, tell your doctor or||
2429|088|P|pharmacist if you are allergic to it; or if you have any other||
2429|089|P|allergies. This product may contain inactive ingredients, which||
2429|090|P|can cause allergic reactions or other problems. Talk to your||
2429|091|P|pharmacist for more details.||
2429|092|P|   Before using this medication, tell your doctor or pharmacist||
2429|093|P|your medical history, especially of: vaginal sores (ulcers).||
2429|094|P|   Before having surgery, tell your doctor or dentist about all||
2429|095|P|the products you use (including prescription drugs,||
2429|096|P|nonprescription drugs, and herbal products).||
2429|097|P|   During pregnancy, this medication should be used only when||
2429|098|P|clearly needed. To prevent dequalinium from getting on your baby,||
2429|099|P|do not use this medication within 12 hours before labor/delivery.||
2429|100|P|Discuss the risks and benefits with your doctor.||
2429|101|P|   It is unknown if this medication passes into breast milk.||
2429|102|P|However, it is unlikely to pass into breast milk. Consult your||
2429|103|P|doctor before breastfeeding.||
2429|104|B|||
2429|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2429|106|I|medications work or increase your risk for serious side effects.||
2429|107|I|This document does not contain all possible drug interactions.||
2429|108|I|Keep a list of all the products you use (including||
2429|109|I|prescription/nonprescription drugs and herbal products) and share||
2429|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
2429|111|I|the dosage of any medicines without your doctor's approval.||
2429|112|B|||
2429|113|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2429|114|O|has overdosed and has serious symptoms such as passing out or||
2429|115|O|trouble breathing, call 911. Otherwise, call a poison control||
2429|116|O|center right away. US residents can call 1-800-222-1222. Canada||
2429|117|O|residents can call 1-844-764-7669.||
2429|118|B|||
2429|119|N|NOTES:  Do not share this medication with others.||
2429|120|N|   This medication has been prescribed for your current condition||
2429|121|N|only. Do not use it later for another infection unless your||
2429|122|N|doctor tells you to.||
2429|123|B|||
2429|124|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
2429|125|D|next dose at the regular time. Do not double the dose to catch||
2429|126|D|up. Do not use more than one tablet a day. Keep using one tablet||
2429|127|D|at bedtime until all 6 tablets are used.||
2429|128|B|||
2429|129|R|STORAGE:  Store at room temperature. Keep all medications away||
2429|130|R|from children and pets.||
2429|131|R|   Do not flush medications down the toilet or pour them into a||
2429|132|R|drain unless instructed to do so. Properly discard this product||
2429|133|R|when it is expired or no longer needed. Consult your pharmacist||
2429|134|R|or local waste disposal company.||
2429|135|B|||
2429|136|A|Information last revised January 2025.||
2429|137|A|Copyright(c) 2025 First Databank, Inc.||
2429|138|B|||
2430|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2430|002|Z|does NOT have all possible information about this product. This||
2430|003|Z|information does not assure that this product is safe, effective,||
2430|004|Z|or appropriate for you. This information is not individual||
2430|005|Z|medical advice and does not substitute for the advice of your||
2430|006|Z|health care professional. Always ask your health care||
2430|007|Z|professional for complete information about this product and your||
2430|008|Z|specific health needs.||
2430|009|B|||
2430|010|T|METHYLPHENIDATE SUSTAINED-ACTION CD - ORAL||
2430|011|F|(METH-il-FEN-i-date)||
2430|012|B|||
2430|013|C|COMMON BRAND NAME(S): Metadate CD||
2430|014|B|||
2430|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
2430|016|W|serious (possibly fatal) heart and blood pressure problems.||
2430|017|W|   This medication can be habit-forming and should be used||
2430|018|W|cautiously by people who have mental/mood disorders or a||
2430|019|W|substance use disorder (such as overuse of or addiction to||
2430|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
2430|021|W|you have a personal or family history of a substance use||
2430|022|W|disorder. Do not increase your dose, use it more often, or use it||
2430|023|W|for a longer time or in a different way than prescribed. Doing so||
2430|024|W|may result in a decrease in the effect of this drug, drug||
2430|025|W|dependence, or abnormal thoughts/behavior.||
2430|026|W|   Your doctor may monitor you for a while after the medication||
2430|027|W|is stopped, especially if you have taken this drug for a long||
2430|028|W|time or in high doses. (See also How to Use section.)||
2430|029|B|||
2430|030|U|USES:  This medication is used to treat attention deficit||
2430|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
2430|032|U|of certain natural substances in the brain. Methylphenidate||
2430|033|U|belongs to a class of drugs known as stimulants. It can help||
2430|034|U|increase your ability to pay attention, stay focused on an||
2430|035|U|activity, and control behavior problems. It may also help you to||
2430|036|U|organize your tasks and improve listening skills.||
2430|037|B|||
2430|038|V|OTHER USES:  This section contains uses of this drug that are not||
2430|039|V|listed in the approved professional labeling for the drug but||
2430|040|V|that may be prescribed by your health care professional. Use this||
2430|041|V|drug for a condition that is listed in this section only if it||
2430|042|V|has been so prescribed by your health care professional.||
2430|043|V|   This drug may also be used for a certain sleep disorder||
2430|044|V|(narcolepsy).||
2430|045|B|||
2430|046|H|HOW TO USE:  Read the Medication Guide provided by your||
2430|047|H|pharmacist before you start taking methylphenidate and each time||
2430|048|H|you get a refill. If you have any questions, ask your doctor or||
2430|049|H|pharmacist.||
2430|050|H|   There are different brands and forms of this medication||
2430|051|H|available. They may not have the same effects and may not be||
2430|052|H|interchangeable. Do not change brands or forms without consulting||
2430|053|H|your doctor or pharmacist.||
2430|054|H|   Take this medication by mouth as directed by your doctor,||
2430|055|H|usually once daily before or with breakfast. If you have upset||
2430|056|H|stomach, you may take this medication with food. Taking this||
2430|057|H|medication late in the day may cause trouble sleeping (insomnia).||
2430|058|H|   Do not break, crush, or chew this medication. Doing so can||
2430|059|H|release all of the drug at once, increasing the risk of side||
2430|060|H|effects. Swallow the capsules whole. If you have trouble||
2430|061|H|swallowing the capsule, you may open the capsule and carefully||
2430|062|H|sprinkle its contents on a spoonful of cool applesauce. Swallow||
2430|063|H|all of the mixture right away without chewing it. Then drink a||
2430|064|H|glass of cool liquid to make sure you have swallowed all of the||
2430|065|H|dose. Do not prepare the mixture ahead of time.||
2430|066|H|   Do not drink alcoholic beverages while you are taking this||
2430|067|H|medication. Drinking alcohol may increase the amount of this||
2430|068|H|medication in your body which may cause serious side effects.||
2430|069|H|   Take this medication regularly to get the most benefit from||
2430|070|H|it. To help you remember, take it at the same time each day.||
2430|071|H|   The dosage is based on your medical condition and response to||
2430|072|H|treatment. Your doctor may direct you to gradually increase or||
2430|073|H|decrease your dose. Also, if you have used it for a long time, do||
2430|074|H|not suddenly stop using this drug without consulting your doctor.||
2430|075|H|   If you suddenly stop using this medication, you may have||
2430|076|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
2430|077|H|other mental/mood changes). To help prevent withdrawal, your||
2430|078|H|doctor may lower your dose slowly. Withdrawal is more likely if||
2430|079|H|you have used methylphenidate for a long time or in high doses.||
2430|080|H|Tell your doctor or pharmacist right away if you have withdrawal.||
2430|081|H|   When used for a long time, this medication may not work as||
2430|082|H|well. Talk with your doctor if this medication stops working||
2430|083|H|well.||
2430|084|H|   Though it helps many people, this medication may sometimes||
2430|085|H|cause addiction. This risk may be higher if you have a substance||
2430|086|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2430|087|H|Take this medication exactly as prescribed to lower the risk of||
2430|088|H|addiction. Ask your doctor or pharmacist for more details.||
2430|089|H|   Tell your doctor if your condition does not get better or if||
2430|090|H|it gets worse.||
2430|091|B|||
2430|092|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
2430|093|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
2430|094|S|If any of these effects last or get worse, tell your doctor or||
2430|095|S|pharmacist promptly.||
2430|096|S|   Remember that this medication has been prescribed because your||
2430|097|S|doctor has judged that the benefit to you is greater than the||
2430|098|S|risk of side effects. Many people using this medication do not||
2430|099|S|have serious side effects.||
2430|100|S|   This medication may raise your blood pressure. Check your||
2430|101|S|blood pressure regularly and tell your doctor if the results are||
2430|102|S|high.||
2430|103|S|   Tell your doctor right away if you have any serious side||
2430|104|S|effects, including: signs of blood flow problems in the fingers||
2430|105|S|or toes (such as coldness, numbness, pain, or skin color||
2430|106|S|changes), unusual wounds on the fingers or toes,||
2430|107|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
2430|108|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
2430|109|S|thoughts of suicide), uncontrolled muscle movements (such as||
2430|110|S|twitching, shaking), sudden outbursts of words/sounds that are||
2430|111|S|hard to control, vision changes (such as blurred vision), slow||
2430|112|S|healing sores/ulcers on the tips of fingers/toes.||
2430|113|S|   Get medical help right away if you have any very serious side||
2430|114|S|effects, including: fainting, seizure, symptoms of a heart attack||
2430|115|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
2430|116|S|sweating), symptoms of a stroke (such as weakness on one side of||
2430|117|S|the body, trouble speaking, sudden vision changes, confusion).||
2430|118|S|   Rarely, males (including young boys and teens) may have a||
2430|119|S|painful or prolonged erection lasting 4 or more hours while using||
2430|120|S|this medication. Caregivers/parents should also be watchful for||
2430|121|S|this serious side effect in boys. If a painful or prolonged||
2430|122|S|erection occurs, stop using this drug and get medical help right||
2430|123|S|away, or permanent problems could occur. Ask your doctor or||
2430|124|S|pharmacist for more details.||
2430|125|S|   A very serious allergic reaction to this drug is rare.||
2430|126|S|However, get medical help right away if you notice any symptoms||
2430|127|S|of a serious allergic reaction, including: rash, itching/swelling||
2430|128|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2430|129|S|breathing.||
2430|130|S|   This is not a complete list of possible side effects. If you||
2430|131|S|notice other effects not listed above, contact your doctor or||
2430|132|S|pharmacist.||
2430|133|S|   In the US -||
2430|134|S|   Call your doctor for medical advice about side effects. You||
2430|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2430|136|S|www.fda.gov/medwatch.||
2430|137|S|   In Canada - Call your doctor for medical advice about side||
2430|138|S|effects. You may report side effects to Health Canada at||
2430|139|S|1-866-234-2345.||
2430|140|B|||
2430|141|P|PRECAUTIONS:  See also Warning section.||
2430|142|P|   Before taking methylphenidate, tell your doctor or pharmacist||
2430|143|P|if you are allergic to it; or to dexmethylphenidate; or if you||
2430|144|P|have any other allergies. This product may contain inactive||
2430|145|P|ingredients, which can cause allergic reactions or other||
2430|146|P|problems. Talk to your pharmacist for more details.||
2430|147|P|   Before using this medication, tell your doctor or pharmacist||
2430|148|P|your medical history, especially of: high blood pressure, blood||
2430|149|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
2430|150|P|problems (such as irregular heartbeat, heart failure, previous||
2430|151|P|heart attack, problems with heart structure), family history of||
2430|152|P|heart problems (such as sudden cardiac death, irregular||
2430|153|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
2430|154|P|agitation), personal/family history of mental/mood disorders||
2430|155|P|(such as bipolar disorder, depression, psychosis, suicidal||
2430|156|P|thoughts), personal/family history of uncontrolled muscle||
2430|157|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
2430|158|P|(hyperthyroidism), seizure disorder, throat/stomach/intestinal||
2430|159|P|problems (such as narrowing/blockage).||
2430|160|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2430|161|P|can make you more dizzy. Do not drive, use machinery, or do||
2430|162|P|anything that needs alertness until you can do it safely. Avoid||
2430|163|P|alcoholic beverages. Talk to your doctor if you are using||
2430|164|P|marijuana (cannabis).||
2430|165|P|   Before having surgery, tell your doctor or dentist about all||
2430|166|P|the products you use (including prescription drugs,||
2430|167|P|nonprescription drugs, and herbal products).||
2430|168|P|   Some brands of this medication may contain sugar. Caution is||
2430|169|P|advised if you have diabetes, fructose intolerance, or any other||
2430|170|P|condition that requires you to limit/avoid sugar in your diet.||
2430|171|P|Ask your doctor or pharmacist about using this medication safely.||
2430|172|P|   Children (especially those younger than 6) may be more||
2430|173|P|sensitive to the side effects of this drug, especially weight||
2430|174|P|loss. If used for a long time, this drug may affect a child's||
2430|175|P|growth rate, weight, and final adult height. To reduce the risk,||
2430|176|P|the doctor may recommend briefly stopping the medication from||
2430|177|P|time to time. Check the child's weight and height regularly, and||
2430|178|P|consult your doctor or pharmacist for more details.||
2430|179|P|   Older adults may be more sensitive to the side effects of this||
2430|180|P|drug, especially trouble sleeping, weight loss, or chest pain.||
2430|181|P|   During pregnancy, methylphenidate should be used only when||
2430|182|P|clearly needed. Discuss the risks and benefits with your doctor.||
2430|183|P|   This medication passes into breast milk. Consult your doctor||
2430|184|P|before breastfeeding.||
2430|185|B|||
2430|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2430|187|I|medications work or increase your risk for serious side effects.||
2430|188|I|This document does not contain all possible drug interactions.||
2430|189|I|Keep a list of all the products you use (including||
2430|190|I|prescription/nonprescription drugs and herbal products) and share||
2430|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
2430|192|I|the dosage of any medicines without your doctor's approval.||
2430|193|I|   Taking MAO inhibitors with this medication may cause a serious||
2430|194|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2430|195|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2430|196|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2430|197|I|selegiline, tranylcypromine) during treatment with this||
2430|198|I|medication. Most MAO inhibitors should also not be taken for two||
2430|199|I|weeks before treatment with this medication. Ask your doctor when||
2430|200|I|to start or stop taking this medication.||
2430|201|I|   Avoid alcohol when using this medication because it may cause||
2430|202|I|the medication to be released too quickly and increase the risk||
2430|203|I|of side effects.||
2430|204|I|   Some brands of this drug may be affected by a change in the||
2430|205|I|amount of acid in your stomach. If you are taking a product to||
2430|206|I|decrease stomach acid (such as antacids, ranitidine, omeprazole),||
2430|207|I|check with your pharmacist to see if your brand may be affected.||
2430|208|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
2430|209|I|use medications containing dexmethylphenidate while using||
2430|210|I|methylphenidate.||
2430|211|I|   This medication may interfere with certain medical/lab tests||
2430|212|I|(such as brain scan for Parkinson's disease), possibly causing||
2430|213|I|false test results. Make sure lab personnel and all your doctors||
2430|214|I|know you use this drug.||
2430|215|B|||
2430|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2430|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2430|218|O|poison control center right away. US residents can call||
2430|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2430|220|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
2430|221|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
2430|222|O|loss of consciousness.||
2430|223|B|||
2430|224|N|NOTES:  Do not share this medication with others. Sharing it is||
2430|225|N|against the law.||
2430|226|N|   Lab and/or medical tests (such as blood pressure, complete||
2430|227|N|blood count, height/weight monitoring in children) may be done||
2430|228|N|while you are taking this medication. Keep all medical and lab||
2430|229|N|appointments. Consult your doctor for more details.||
2430|230|B|||
2430|231|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2430|232|D|remember. If it is near bedtime or near the time of the next||
2430|233|D|dose, skip the missed dose. Take your next dose at the regular||
2430|234|D|time. Do not double the dose to catch up.||
2430|235|B|||
2430|236|R|STORAGE:  Store this medication at room temperature away from||
2430|237|R|light and moisture. Do not store in the bathroom. Keep all||
2430|238|R|medications away from children and pets.||
2430|239|R|   Do not flush medications down the toilet or pour them into a||
2430|240|R|drain unless instructed to do so. Properly discard this product||
2430|241|R|when it is expired or no longer needed. Consult your pharmacist||
2430|242|R|or local waste disposal company.||
2430|243|B|||
2430|244|A|Information last revised July 2025.||
2430|245|A|Copyright(c) 2025 First Databank, Inc.||
2430|246|B|||
2431|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2431|002|Z|does NOT have all possible information about this product. This||
2431|003|Z|information does not assure that this product is safe, effective,||
2431|004|Z|or appropriate for you. This information is not individual||
2431|005|Z|medical advice and does not substitute for the advice of your||
2431|006|Z|health care professional. Always ask your health care||
2431|007|Z|professional for complete information about this product and your||
2431|008|Z|specific health needs.||
2431|009|B|||
2431|010|T|METHYLPHENIDATE SUSTAINED-ACTION ER - ORAL||
2431|011|F|(METH-il-FEN-i-date)||
2431|012|B|||
2431|013|C|COMMON BRAND NAME(S): Aptensio XR||
2431|014|B|||
2431|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
2431|016|W|serious (possibly fatal) heart and blood pressure problems.||
2431|017|W|   This medication can be habit-forming and should be used||
2431|018|W|cautiously by people who have mental/mood disorders or a||
2431|019|W|substance use disorder (such as overuse of or addiction to||
2431|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
2431|021|W|you have a personal or family history of a substance use||
2431|022|W|disorder. Do not increase your dose, use it more often, or use it||
2431|023|W|for a longer time or in a different way than prescribed. Doing so||
2431|024|W|may result in a decrease in the effect of this drug, drug||
2431|025|W|dependence, or abnormal thoughts/behavior.||
2431|026|W|   Your doctor may monitor you for a while after the medication||
2431|027|W|is stopped, especially if you have taken this drug for a long||
2431|028|W|time or in high doses. (See also How to Use section.)||
2431|029|B|||
2431|030|U|USES:  This medication is used to treat attention deficit||
2431|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
2431|032|U|of certain natural substances in the brain. Methylphenidate||
2431|033|U|belongs to a class of drugs known as stimulants. It can help||
2431|034|U|increase your ability to pay attention, stay focused on an||
2431|035|U|activity, and control behavior problems. It may also help you to||
2431|036|U|organize your tasks and improve listening skills.||
2431|037|B|||
2431|038|V|OTHER USES:  This section contains uses of this drug that are not||
2431|039|V|listed in the approved professional labeling for the drug but||
2431|040|V|that may be prescribed by your health care professional. Use this||
2431|041|V|drug for a condition that is listed in this section only if it||
2431|042|V|has been so prescribed by your health care professional.||
2431|043|V|   This drug may also be used for a certain sleep disorder||
2431|044|V|(narcolepsy).||
2431|045|B|||
2431|046|H|HOW TO USE:  Read the Medication Guide provided by your||
2431|047|H|pharmacist before you start taking methylphenidate and each time||
2431|048|H|you get a refill. If you have any questions, ask your doctor or||
2431|049|H|pharmacist.||
2431|050|H|   There are different brands and forms of this medication||
2431|051|H|available. They may not have the same effects and may not be||
2431|052|H|interchangeable. Do not change brands or forms without consulting||
2431|053|H|your doctor or pharmacist.||
2431|054|H|   Take this medication by mouth as directed by your doctor,||
2431|055|H|usually once daily before or with breakfast. If you have upset||
2431|056|H|stomach, you may take this medication with food. Taking this||
2431|057|H|medication late in the day may cause trouble sleeping (insomnia).||
2431|058|H|   Do not break, crush, or chew this medication. Doing so can||
2431|059|H|release all of the drug at once, increasing the risk of side||
2431|060|H|effects. Swallow the capsules whole. If you have trouble||
2431|061|H|swallowing the capsule, you may open the capsule and carefully||
2431|062|H|sprinkle its contents on a spoonful of cool applesauce. Swallow||
2431|063|H|all of the mixture right away without chewing it. Then drink a||
2431|064|H|glass of cool liquid to make sure you have swallowed all of the||
2431|065|H|dose. Do not prepare the mixture ahead of time.||
2431|066|H|   Do not drink alcoholic beverages while you are taking this||
2431|067|H|medication. Drinking alcohol may increase the amount of this||
2431|068|H|medication in your body which may cause serious side effects.||
2431|069|H|   Take this medication regularly to get the most benefit from||
2431|070|H|it. To help you remember, take it at the same time each day.||
2431|071|H|   The dosage is based on your medical condition and response to||
2431|072|H|treatment. Your doctor may direct you to gradually increase or||
2431|073|H|decrease your dose. Also, if you have used it for a long time, do||
2431|074|H|not suddenly stop using this drug without consulting your doctor.||
2431|075|H|   If you suddenly stop using this medication, you may have||
2431|076|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
2431|077|H|other mental/mood changes). To help prevent withdrawal, your||
2431|078|H|doctor may lower your dose slowly. Withdrawal is more likely if||
2431|079|H|you have used methylphenidate for a long time or in high doses.||
2431|080|H|Tell your doctor or pharmacist right away if you have withdrawal.||
2431|081|H|   When used for a long time, this medication may not work as||
2431|082|H|well. Talk with your doctor if this medication stops working||
2431|083|H|well.||
2431|084|H|   Though it helps many people, this medication may sometimes||
2431|085|H|cause addiction. This risk may be higher if you have a substance||
2431|086|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2431|087|H|Take this medication exactly as prescribed to lower the risk of||
2431|088|H|addiction. Ask your doctor or pharmacist for more details.||
2431|089|H|   Tell your doctor if your condition does not get better or if||
2431|090|H|it gets worse.||
2431|091|B|||
2431|092|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
2431|093|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
2431|094|S|If any of these effects last or get worse, tell your doctor or||
2431|095|S|pharmacist promptly.||
2431|096|S|   Remember that this medication has been prescribed because your||
2431|097|S|doctor has judged that the benefit to you is greater than the||
2431|098|S|risk of side effects. Many people using this medication do not||
2431|099|S|have serious side effects.||
2431|100|S|   This medication may raise your blood pressure. Check your||
2431|101|S|blood pressure regularly and tell your doctor if the results are||
2431|102|S|high.||
2431|103|S|   Tell your doctor right away if you have any serious side||
2431|104|S|effects, including: signs of blood flow problems in the fingers||
2431|105|S|or toes (such as coldness, numbness, pain, or skin color||
2431|106|S|changes), unusual wounds on the fingers or toes,||
2431|107|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
2431|108|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
2431|109|S|thoughts of suicide), uncontrolled muscle movements (such as||
2431|110|S|twitching, shaking), sudden outbursts of words/sounds that are||
2431|111|S|hard to control, vision changes (such as blurred vision), slow||
2431|112|S|healing sores/ulcers on the tips of fingers/toes.||
2431|113|S|   Get medical help right away if you have any very serious side||
2431|114|S|effects, including: fainting, seizure, symptoms of a heart attack||
2431|115|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
2431|116|S|sweating), symptoms of a stroke (such as weakness on one side of||
2431|117|S|the body, trouble speaking, sudden vision changes, confusion).||
2431|118|S|   Rarely, males (including young boys and teens) may have a||
2431|119|S|painful or prolonged erection lasting 4 or more hours while using||
2431|120|S|this medication. Caregivers/parents should also be watchful for||
2431|121|S|this serious side effect in boys. If a painful or prolonged||
2431|122|S|erection occurs, stop using this drug and get medical help right||
2431|123|S|away, or permanent problems could occur. Ask your doctor or||
2431|124|S|pharmacist for more details.||
2431|125|S|   A very serious allergic reaction to this drug is rare.||
2431|126|S|However, get medical help right away if you notice any symptoms||
2431|127|S|of a serious allergic reaction, including: rash, itching/swelling||
2431|128|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2431|129|S|breathing.||
2431|130|S|   This is not a complete list of possible side effects. If you||
2431|131|S|notice other effects not listed above, contact your doctor or||
2431|132|S|pharmacist.||
2431|133|S|   In the US -||
2431|134|S|   Call your doctor for medical advice about side effects. You||
2431|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2431|136|S|www.fda.gov/medwatch.||
2431|137|S|   In Canada - Call your doctor for medical advice about side||
2431|138|S|effects. You may report side effects to Health Canada at||
2431|139|S|1-866-234-2345.||
2431|140|B|||
2431|141|P|PRECAUTIONS:  See also Warning section.||
2431|142|P|   Before taking methylphenidate, tell your doctor or pharmacist||
2431|143|P|if you are allergic to it; or to dexmethylphenidate; or if you||
2431|144|P|have any other allergies. This product may contain inactive||
2431|145|P|ingredients, which can cause allergic reactions or other||
2431|146|P|problems. Talk to your pharmacist for more details.||
2431|147|P|   Before using this medication, tell your doctor or pharmacist||
2431|148|P|your medical history, especially of: high blood pressure, blood||
2431|149|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
2431|150|P|problems (such as irregular heartbeat, heart failure, previous||
2431|151|P|heart attack, problems with heart structure), family history of||
2431|152|P|heart problems (such as sudden cardiac death, irregular||
2431|153|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
2431|154|P|agitation), personal/family history of mental/mood disorders||
2431|155|P|(such as bipolar disorder, depression, psychosis, suicidal||
2431|156|P|thoughts), personal/family history of uncontrolled muscle||
2431|157|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
2431|158|P|(hyperthyroidism), seizure disorder, throat/stomach/intestinal||
2431|159|P|problems (such as narrowing/blockage).||
2431|160|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2431|161|P|can make you more dizzy. Do not drive, use machinery, or do||
2431|162|P|anything that needs alertness until you can do it safely. Avoid||
2431|163|P|alcoholic beverages. Talk to your doctor if you are using||
2431|164|P|marijuana (cannabis).||
2431|165|P|   Before having surgery, tell your doctor or dentist about all||
2431|166|P|the products you use (including prescription drugs,||
2431|167|P|nonprescription drugs, and herbal products).||
2431|168|P|   Some brands of this medication may contain sugar. Caution is||
2431|169|P|advised if you have diabetes, fructose intolerance, or any other||
2431|170|P|condition that requires you to limit/avoid sugar in your diet.||
2431|171|P|Ask your doctor or pharmacist about using this medication safely.||
2431|172|P|   Children (especially those younger than 6) may be more||
2431|173|P|sensitive to the side effects of this drug, especially weight||
2431|174|P|loss. If used for a long time, this drug may affect a child's||
2431|175|P|growth rate, weight, and final adult height. To reduce the risk,||
2431|176|P|the doctor may recommend briefly stopping the medication from||
2431|177|P|time to time. Check the child's weight and height regularly, and||
2431|178|P|consult your doctor or pharmacist for more details.||
2431|179|P|   Older adults may be more sensitive to the side effects of this||
2431|180|P|drug, especially trouble sleeping, weight loss, or chest pain.||
2431|181|P|   During pregnancy, methylphenidate should be used only when||
2431|182|P|clearly needed. Discuss the risks and benefits with your doctor.||
2431|183|P|   This medication passes into breast milk. Consult your doctor||
2431|184|P|before breastfeeding.||
2431|185|B|||
2431|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2431|187|I|medications work or increase your risk for serious side effects.||
2431|188|I|This document does not contain all possible drug interactions.||
2431|189|I|Keep a list of all the products you use (including||
2431|190|I|prescription/nonprescription drugs and herbal products) and share||
2431|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
2431|192|I|the dosage of any medicines without your doctor's approval.||
2431|193|I|   Taking MAO inhibitors with this medication may cause a serious||
2431|194|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2431|195|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2431|196|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2431|197|I|selegiline, tranylcypromine) during treatment with this||
2431|198|I|medication. Most MAO inhibitors should also not be taken for two||
2431|199|I|weeks before treatment with this medication. Ask your doctor when||
2431|200|I|to start or stop taking this medication.||
2431|201|I|   Avoid alcohol when using this medication because it may cause||
2431|202|I|the medication to be released too quickly and increase the risk||
2431|203|I|of side effects.||
2431|204|I|   Some brands of this drug may be affected by a change in the||
2431|205|I|amount of acid in your stomach. If you are taking a product to||
2431|206|I|decrease stomach acid (such as antacids, ranitidine, omeprazole),||
2431|207|I|check with your pharmacist to see if your brand may be affected.||
2431|208|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
2431|209|I|use medications containing dexmethylphenidate while using||
2431|210|I|methylphenidate.||
2431|211|I|   This medication may interfere with certain medical/lab tests||
2431|212|I|(such as brain scan for Parkinson's disease), possibly causing||
2431|213|I|false test results. Make sure lab personnel and all your doctors||
2431|214|I|know you use this drug.||
2431|215|B|||
2431|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2431|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2431|218|O|poison control center right away. US residents can call||
2431|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2431|220|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
2431|221|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
2431|222|O|loss of consciousness.||
2431|223|B|||
2431|224|N|NOTES:  Do not share this medication with others. Sharing it is||
2431|225|N|against the law.||
2431|226|N|   Lab and/or medical tests (such as blood pressure, complete||
2431|227|N|blood count, height/weight monitoring in children) may be done||
2431|228|N|while you are taking this medication. Keep all medical and lab||
2431|229|N|appointments. Consult your doctor for more details.||
2431|230|B|||
2431|231|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2431|232|D|remember. If it is near bedtime or near the time of the next||
2431|233|D|dose, skip the missed dose. Take your next dose at the regular||
2431|234|D|time. Do not double the dose to catch up.||
2431|235|B|||
2431|236|R|STORAGE:  Store this medication at room temperature away from||
2431|237|R|light and moisture. Do not store in the bathroom. Keep all||
2431|238|R|medications away from children and pets.||
2431|239|R|   Do not flush medications down the toilet or pour them into a||
2431|240|R|drain unless instructed to do so. Properly discard this product||
2431|241|R|when it is expired or no longer needed. Consult your pharmacist||
2431|242|R|or local waste disposal company.||
2431|243|B|||
2431|244|A|Information last revised July 2025.||
2431|245|A|Copyright(c) 2025 First Databank, Inc.||
2431|246|B|||
2432|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2432|002|Z|does NOT have all possible information about this product. This||
2432|003|Z|information does not assure that this product is safe, effective,||
2432|004|Z|or appropriate for you. This information is not individual||
2432|005|Z|medical advice and does not substitute for the advice of your||
2432|006|Z|health care professional. Always ask your health care||
2432|007|Z|professional for complete information about this product and your||
2432|008|Z|specific health needs.||
2432|009|B|||
2432|010|T|METHYLPHENIDATE SUSTAINED-ACTION XR - ORAL||
2432|011|F|(METH-il-FEN-i-date)||
2432|012|B|||
2432|013|C|COMMON BRAND NAME(S): Adhansia XR||
2432|014|B|||
2432|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
2432|016|W|serious (possibly fatal) heart and blood pressure problems.||
2432|017|W|   This medication can be habit-forming and should be used||
2432|018|W|cautiously by people who have mental/mood disorders or a||
2432|019|W|substance use disorder (such as overuse of or addiction to||
2432|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
2432|021|W|you have a personal or family history of a substance use||
2432|022|W|disorder. Do not increase your dose, use it more often, or use it||
2432|023|W|for a longer time or in a different way than prescribed. Doing so||
2432|024|W|may result in a decrease in the effect of this drug, drug||
2432|025|W|dependence, or abnormal thoughts/behavior.||
2432|026|W|   Your doctor may monitor you for a while after the medication||
2432|027|W|is stopped, especially if you have taken this drug for a long||
2432|028|W|time or in high doses. (See also How to Use section.)||
2432|029|B|||
2432|030|U|USES:  This medication is used to treat attention deficit||
2432|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
2432|032|U|of certain natural substances in the brain. Methylphenidate||
2432|033|U|belongs to a class of drugs known as stimulants. It can help||
2432|034|U|increase your ability to pay attention, stay focused on an||
2432|035|U|activity, and control behavior problems. It may also help you to||
2432|036|U|organize your tasks and improve listening skills.||
2432|037|B|||
2432|038|V|OTHER USES:  This section contains uses of this drug that are not||
2432|039|V|listed in the approved professional labeling for the drug but||
2432|040|V|that may be prescribed by your health care professional. Use this||
2432|041|V|drug for a condition that is listed in this section only if it||
2432|042|V|has been so prescribed by your health care professional.||
2432|043|V|   This drug may also be used for a certain sleep disorder||
2432|044|V|(narcolepsy).||
2432|045|B|||
2432|046|H|HOW TO USE:  Read the Medication Guide provided by your||
2432|047|H|pharmacist before you start taking methylphenidate and each time||
2432|048|H|you get a refill. If you have any questions, ask your doctor or||
2432|049|H|pharmacist.||
2432|050|H|   There are different brands and forms of this medication||
2432|051|H|available. They may not have the same effects and may not be||
2432|052|H|interchangeable. Do not change brands or forms without consulting||
2432|053|H|your doctor or pharmacist.||
2432|054|H|   Take this medication by mouth as directed by your doctor,||
2432|055|H|usually once daily before or with breakfast. If you have upset||
2432|056|H|stomach, you may take this medication with food. Taking this||
2432|057|H|medication late in the day may cause trouble sleeping (insomnia).||
2432|058|H|   Do not break, crush, or chew this medication. Doing so can||
2432|059|H|release all of the drug at once, increasing the risk of side||
2432|060|H|effects. Swallow the capsules whole. If you have trouble||
2432|061|H|swallowing the capsule, you may open the capsule and carefully||
2432|062|H|sprinkle its contents on a spoonful of cool applesauce. Swallow||
2432|063|H|all of the mixture right away without chewing it. Then drink a||
2432|064|H|glass of cool liquid to make sure you have swallowed all of the||
2432|065|H|dose. Do not prepare the mixture ahead of time.||
2432|066|H|   Do not drink alcoholic beverages while you are taking this||
2432|067|H|medication. Drinking alcohol may increase the amount of this||
2432|068|H|medication in your body which may cause serious side effects.||
2432|069|H|   Take this medication regularly to get the most benefit from||
2432|070|H|it. To help you remember, take it at the same time each day.||
2432|071|H|   The dosage is based on your medical condition and response to||
2432|072|H|treatment. Your doctor may direct you to gradually increase or||
2432|073|H|decrease your dose. Also, if you have used it for a long time, do||
2432|074|H|not suddenly stop using this drug without consulting your doctor.||
2432|075|H|   If you suddenly stop using this medication, you may have||
2432|076|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
2432|077|H|other mental/mood changes). To help prevent withdrawal, your||
2432|078|H|doctor may lower your dose slowly. Withdrawal is more likely if||
2432|079|H|you have used methylphenidate for a long time or in high doses.||
2432|080|H|Tell your doctor or pharmacist right away if you have withdrawal.||
2432|081|H|   When used for a long time, this medication may not work as||
2432|082|H|well. Talk with your doctor if this medication stops working||
2432|083|H|well.||
2432|084|H|   Though it helps many people, this medication may sometimes||
2432|085|H|cause addiction. This risk may be higher if you have a substance||
2432|086|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2432|087|H|Take this medication exactly as prescribed to lower the risk of||
2432|088|H|addiction. Ask your doctor or pharmacist for more details.||
2432|089|H|   Tell your doctor if your condition does not get better or if||
2432|090|H|it gets worse.||
2432|091|B|||
2432|092|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
2432|093|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
2432|094|S|If any of these effects last or get worse, tell your doctor or||
2432|095|S|pharmacist promptly.||
2432|096|S|   Remember that this medication has been prescribed because your||
2432|097|S|doctor has judged that the benefit to you is greater than the||
2432|098|S|risk of side effects. Many people using this medication do not||
2432|099|S|have serious side effects.||
2432|100|S|   This medication may raise your blood pressure. Check your||
2432|101|S|blood pressure regularly and tell your doctor if the results are||
2432|102|S|high.||
2432|103|S|   Tell your doctor right away if you have any serious side||
2432|104|S|effects, including: signs of blood flow problems in the fingers||
2432|105|S|or toes (such as coldness, numbness, pain, or skin color||
2432|106|S|changes), unusual wounds on the fingers or toes,||
2432|107|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
2432|108|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
2432|109|S|thoughts of suicide), uncontrolled muscle movements (such as||
2432|110|S|twitching, shaking), sudden outbursts of words/sounds that are||
2432|111|S|hard to control, vision changes (such as blurred vision), slow||
2432|112|S|healing sores/ulcers on the tips of fingers/toes.||
2432|113|S|   Get medical help right away if you have any very serious side||
2432|114|S|effects, including: fainting, seizure, symptoms of a heart attack||
2432|115|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
2432|116|S|sweating), symptoms of a stroke (such as weakness on one side of||
2432|117|S|the body, trouble speaking, sudden vision changes, confusion).||
2432|118|S|   Rarely, males (including young boys and teens) may have a||
2432|119|S|painful or prolonged erection lasting 4 or more hours while using||
2432|120|S|this medication. Caregivers/parents should also be watchful for||
2432|121|S|this serious side effect in boys. If a painful or prolonged||
2432|122|S|erection occurs, stop using this drug and get medical help right||
2432|123|S|away, or permanent problems could occur. Ask your doctor or||
2432|124|S|pharmacist for more details.||
2432|125|S|   A very serious allergic reaction to this drug is rare.||
2432|126|S|However, get medical help right away if you notice any symptoms||
2432|127|S|of a serious allergic reaction, including: rash, itching/swelling||
2432|128|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2432|129|S|breathing.||
2432|130|S|   This is not a complete list of possible side effects. If you||
2432|131|S|notice other effects not listed above, contact your doctor or||
2432|132|S|pharmacist.||
2432|133|S|   In the US -||
2432|134|S|   Call your doctor for medical advice about side effects. You||
2432|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2432|136|S|www.fda.gov/medwatch.||
2432|137|S|   In Canada - Call your doctor for medical advice about side||
2432|138|S|effects. You may report side effects to Health Canada at||
2432|139|S|1-866-234-2345.||
2432|140|B|||
2432|141|P|PRECAUTIONS:  See also Warning section.||
2432|142|P|   Before taking methylphenidate, tell your doctor or pharmacist||
2432|143|P|if you are allergic to it; or to dexmethylphenidate; or if you||
2432|144|P|have any other allergies. This product may contain inactive||
2432|145|P|ingredients, which can cause allergic reactions or other||
2432|146|P|problems. Talk to your pharmacist for more details.||
2432|147|P|   Before using this medication, tell your doctor or pharmacist||
2432|148|P|your medical history, especially of: high blood pressure, blood||
2432|149|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
2432|150|P|problems (such as irregular heartbeat, heart failure, previous||
2432|151|P|heart attack, problems with heart structure), family history of||
2432|152|P|heart problems (such as sudden cardiac death, irregular||
2432|153|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
2432|154|P|agitation), personal/family history of mental/mood disorders||
2432|155|P|(such as bipolar disorder, depression, psychosis, suicidal||
2432|156|P|thoughts), personal/family history of uncontrolled muscle||
2432|157|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
2432|158|P|(hyperthyroidism), seizure disorder, throat/stomach/intestinal||
2432|159|P|problems (such as narrowing/blockage).||
2432|160|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2432|161|P|can make you more dizzy. Do not drive, use machinery, or do||
2432|162|P|anything that needs alertness until you can do it safely. Avoid||
2432|163|P|alcoholic beverages. Talk to your doctor if you are using||
2432|164|P|marijuana (cannabis).||
2432|165|P|   Before having surgery, tell your doctor or dentist about all||
2432|166|P|the products you use (including prescription drugs,||
2432|167|P|nonprescription drugs, and herbal products).||
2432|168|P|   Some brands of this medication may contain sugar. Caution is||
2432|169|P|advised if you have diabetes, fructose intolerance, or any other||
2432|170|P|condition that requires you to limit/avoid sugar in your diet.||
2432|171|P|Ask your doctor or pharmacist about using this medication safely.||
2432|172|P|   Children (especially those younger than 6) may be more||
2432|173|P|sensitive to the side effects of this drug, especially weight||
2432|174|P|loss. If used for a long time, this drug may affect a child's||
2432|175|P|growth rate, weight, and final adult height. To reduce the risk,||
2432|176|P|the doctor may recommend briefly stopping the medication from||
2432|177|P|time to time. Check the child's weight and height regularly, and||
2432|178|P|consult your doctor or pharmacist for more details.||
2432|179|P|   Older adults may be more sensitive to the side effects of this||
2432|180|P|drug, especially trouble sleeping, weight loss, or chest pain.||
2432|181|P|   During pregnancy, methylphenidate should be used only when||
2432|182|P|clearly needed. Discuss the risks and benefits with your doctor.||
2432|183|P|   This medication passes into breast milk. Consult your doctor||
2432|184|P|before breastfeeding.||
2432|185|B|||
2432|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2432|187|I|medications work or increase your risk for serious side effects.||
2432|188|I|This document does not contain all possible drug interactions.||
2432|189|I|Keep a list of all the products you use (including||
2432|190|I|prescription/nonprescription drugs and herbal products) and share||
2432|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
2432|192|I|the dosage of any medicines without your doctor's approval.||
2432|193|I|   Taking MAO inhibitors with this medication may cause a serious||
2432|194|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2432|195|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2432|196|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2432|197|I|selegiline, tranylcypromine) during treatment with this||
2432|198|I|medication. Most MAO inhibitors should also not be taken for two||
2432|199|I|weeks before treatment with this medication. Ask your doctor when||
2432|200|I|to start or stop taking this medication.||
2432|201|I|   Avoid alcohol when using this medication because it may cause||
2432|202|I|the medication to be released too quickly and increase the risk||
2432|203|I|of side effects.||
2432|204|I|   Some brands of this drug may be affected by a change in the||
2432|205|I|amount of acid in your stomach. If you are taking a product to||
2432|206|I|decrease stomach acid (such as antacids, ranitidine, omeprazole),||
2432|207|I|check with your pharmacist to see if your brand may be affected.||
2432|208|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
2432|209|I|use medications containing dexmethylphenidate while using||
2432|210|I|methylphenidate.||
2432|211|I|   This medication may interfere with certain medical/lab tests||
2432|212|I|(such as brain scan for Parkinson's disease), possibly causing||
2432|213|I|false test results. Make sure lab personnel and all your doctors||
2432|214|I|know you use this drug.||
2432|215|B|||
2432|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2432|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2432|218|O|poison control center right away. US residents can call||
2432|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2432|220|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
2432|221|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
2432|222|O|loss of consciousness.||
2432|223|B|||
2432|224|N|NOTES:  Do not share this medication with others. Sharing it is||
2432|225|N|against the law.||
2432|226|N|   Lab and/or medical tests (such as blood pressure, complete||
2432|227|N|blood count, height/weight monitoring in children) may be done||
2432|228|N|while you are taking this medication. Keep all medical and lab||
2432|229|N|appointments. Consult your doctor for more details.||
2432|230|B|||
2432|231|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2432|232|D|remember. If it is near bedtime or near the time of the next||
2432|233|D|dose, skip the missed dose. Take your next dose at the regular||
2432|234|D|time. Do not double the dose to catch up.||
2432|235|B|||
2432|236|R|STORAGE:  Store this medication at room temperature away from||
2432|237|R|light and moisture. Do not store in the bathroom. Keep all||
2432|238|R|medications away from children and pets.||
2432|239|R|   Do not flush medications down the toilet or pour them into a||
2432|240|R|drain unless instructed to do so. Properly discard this product||
2432|241|R|when it is expired or no longer needed. Consult your pharmacist||
2432|242|R|or local waste disposal company.||
2432|243|B|||
2432|244|A|Information last revised July 2025.||
2432|245|A|Copyright(c) 2025 First Databank, Inc.||
2432|246|B|||
2433|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2433|002|Z|does NOT have all possible information about this product. This||
2433|003|Z|information does not assure that this product is safe, effective,||
2433|004|Z|or appropriate for you. This information is not individual||
2433|005|Z|medical advice and does not substitute for the advice of your||
2433|006|Z|health care professional. Always ask your health care||
2433|007|Z|professional for complete information about this product and your||
2433|008|Z|specific health needs.||
2433|009|B|||
2433|010|T|SMALLPOX/MONKEYPOX VACCINE - INJECTION||
2433|011|B|||
2433|012|C|COMMON BRAND NAME(S): Jynneos||
2433|013|B|||
2433|014|U|USES:  This vaccine is used to help prevent smallpox or monkeypox||
2433|015|U|infection. Smallpox and monkeypox are caused by a certain type of||
2433|016|U|virus (orthopox virus). This vaccine contains live viruses that||
2433|017|U|have been weakened. It works by increasing the body's natural||
2433|018|U|defense (immunity) against the viruses.||
2433|019|U|   This vaccine is recommended for people at high risk for the||
2433|020|U|infection. Those at high risk include certain lab, health care,||
2433|021|U|or public health workers, and people who have been exposed to||
2433|022|U|someone infected with an orthopox virus.||
2433|023|U|   Vaccines may not fully protect everyone who receives them.||
2433|024|B|||
2433|025|H|HOW TO USE:  Read all vaccine information available from your||
2433|026|H|health care professional before receiving the vaccine. If you||
2433|027|H|have any questions, ask your health care professional.||
2433|028|H|   This vaccine is given by injection under the skin by a health||
2433|029|H|care professional, usually as 2 doses (4 weeks apart). It is||
2433|030|H|given in the upper arm.||
2433|031|H|    Vaccines are usually given in a series of doses to provide||
2433|032|H|the best protection. Closely follow the vaccination schedule||
2433|033|H|provided by your health care professional. To help you remember,||
2433|034|H|mark your calendar with a reminder.||
2433|035|H|   This vaccine may be given at the same time as other vaccines.||
2433|036|B|||
2433|037|S|SIDE EFFECTS:  Redness/soreness/swelling/itching at the injection||
2433|038|S|site, tiredness, headache, and muscle pain may occur. If any of||
2433|039|S|these effects last or get worse, tell your health care||
2433|040|S|professional promptly.||
2433|041|S|   Rarely, some people have symptoms such as fainting, dizziness,||
2433|042|S|vision changes, or ringing in the ears just after getting a||
2433|043|S|vaccine injection. Tell your health care professional right away||
2433|044|S|if you have any of these symptoms. Sitting or lying down may||
2433|045|S|help, since these symptoms usually don't last long.||
2433|046|S|   Remember that this vaccine has been prescribed because your||
2433|047|S|health care professional has judged that the benefit to you is||
2433|048|S|greater than the risk of side effects. Many people using this||
2433|049|S|vaccine do not have serious side effects.||
2433|050|S|   A very serious allergic reaction to this vaccine is rare.||
2433|051|S|However, get medical help right away if you notice any symptoms||
2433|052|S|of a serious allergic reaction, including: rash, itching/swelling||
2433|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2433|054|S|breathing.||
2433|055|S|   This is not a complete list of possible side effects. If you||
2433|056|S|notice other effects not listed above, contact your health care||
2433|057|S|professional.||
2433|058|S|   Contact the doctor for medical advice about side effects. The||
2433|059|S|following numbers do not provide medical advice, but in the US||
2433|060|S|you may report side effects to the Vaccine Adverse Event||
2433|061|S|Reporting System (VAERS) at 1-800-822-7967. In Canada, you may||
2433|062|S|call the Vaccine Safety Section at Public Health Agency of Canada||
2433|063|S|at 1-866-844-0018.||
2433|064|B|||
2433|065|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
2433|066|P|care professional if you are allergic to it; or if you have any||
2433|067|P|other allergies. This product may contain inactive ingredients,||
2433|068|P|which can cause allergic reactions or other problems. Talk to||
2433|069|P|your pharmacist for more details.||
2433|070|P|   Before receiving this vaccine, tell your health care||
2433|071|P|professional your medical history, especially of: current||
2433|072|P|fever/illness, immune system disorders (such as due to HIV||
2433|073|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
2433|074|P|radiation treatment), certain heart problems (such as||
2433|075|P|myocarditis, pericarditis), vaccination history (including||
2433|076|P|previous reactions to any vaccines).||
2433|077|P|   During pregnancy, this vaccine should be received only when||
2433|078|P|clearly needed. Discuss the risks and benefits with your health||
2433|079|P|care professional.||
2433|080|P|   It is unknown if this vaccine passes into breast milk. Consult||
2433|081|P|your health care professional before breastfeeding.||
2433|082|B|||
2433|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2433|084|I|medications work or increase your risk for serious side effects.||
2433|085|I|This document does not contain all possible drug interactions.||
2433|086|I|Keep a list of all the products you use (including||
2433|087|I|prescription/nonprescription drugs and herbal products) and share||
2433|088|I|it with your health care professional. Do not start, stop, or||
2433|089|I|change the dosage of any medicines without your doctor's||
2433|090|I|approval.||
2433|091|I|   Some products that may interact with this drug are: drugs that||
2433|092|I|weaken the immune system (including cyclosporine, tacrolimus,||
2433|093|I|cancer chemotherapy, corticosteroids such as prednisone).||
2433|094|B|||
2433|095|O|OVERDOSE:  Not applicable.||
2433|096|B|||
2433|097|N|NOTES:  Keep all medical and lab appointments.||
2433|098|N|   Keep vaccine records for yourself and your children and||
2433|099|N|provide them to the health care professionals to prevent||
2433|100|N|unnecessary re-vaccinations.||
2433|101|B|||
2433|102|D|MISSED DOSE:  It is important that you get each vaccination as||
2433|103|D|scheduled. Ask when you should get each dose and mark your||
2433|104|D|calendar with a reminder. If you miss a dose, call the health||
2433|105|D|care professional to reschedule.||
2433|106|B|||
2433|107|R|STORAGE:  Not applicable. This vaccine is given in a hospital or||
2433|108|R|clinic and will not be stored at home.||
2433|109|B|||
2433|110|A|Information last revised February 2025.||
2433|111|A|Copyright(c) 2025 First Databank, Inc.||
2433|112|B|||
2434|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2434|002|Z|does NOT have all possible information about this product. This||
2434|003|Z|information does not assure that this product is safe, effective,||
2434|004|Z|or appropriate for you. This information is not individual||
2434|005|Z|medical advice and does not substitute for the advice of your||
2434|006|Z|health care professional. Always ask your health care||
2434|007|Z|professional for complete information about this product and your||
2434|008|Z|specific health needs.||
2434|009|B|||
2434|010|T|FINGOLIMOD DISINTEGRATING TABLET - ORAL||
2434|011|F|(fin-GOL-i-mod)||
2434|012|B|||
2434|013|C|COMMON BRAND NAME(S): Tascenso ODT||
2434|014|B|||
2434|015|U|USES:  This medication is used to treat multiple sclerosis (MS).||
2434|016|U|Fingolimod is not a cure for MS but it is thought to help by||
2434|017|U|preventing immune system cells (lymphocytes) from attacking the||
2434|018|U|nerves in your brain and spinal cord. It helps decrease the||
2434|019|U|number of episodes of disease worsening (relapses) and may||
2434|020|U|prevent or delay disability.||
2434|021|B|||
2434|022|H|HOW TO USE:  Read the Medication Guide provided by your||
2434|023|H|pharmacist before you start taking fingolimod and each time you||
2434|024|H|get a refill. If you have any questions, ask your doctor or||
2434|025|H|pharmacist.||
2434|026|H|   Take this medication by mouth with or without food as directed||
2434|027|H|by your doctor, usually once a day. Children's dosage is based on||
2434|028|H|weight. Dry your hands before peeling back the foil on the||
2434|029|H|blister pack to carefully remove a tablet. Do not push the tablet||
2434|030|H|through the foil. Place each dose on the tongue, allow it to||
2434|031|H|dissolve completely, then swallow it with saliva. Do not remove||
2434|032|H|the tablet from the blister pack until just before taking. You do||
2434|033|H|not need to take this medication with water.||
2434|034|H|   Do not stop taking this medication without consulting your||
2434|035|H|doctor. Your condition may become worse when this drug is||
2434|036|H|stopped. Tell your doctor right away if your MS symptoms are much||
2434|037|H|worse after stopping fingolimod.||
2434|038|H|   Do not increase your dose or use this drug more often or for||
2434|039|H|longer than prescribed. Your condition will not improve any||
2434|040|H|faster, and your risk of side effects will increase.||
2434|041|H|   Take this medication regularly to get the most benefit from||
2434|042|H|it. To help you remember, take it at the same time each day.||
2434|043|H|   Tell your doctor if your condition gets worse.||
2434|044|B|||
2434|045|S|SIDE EFFECTS:  Headache, back pain, nausea, or diarrhea may||
2434|046|S|occur. If any of these effects last or get worse, tell your||
2434|047|S|doctor or pharmacist promptly.||
2434|048|S|   Slow heartbeat may also occur, especially when you first start||
2434|049|S|this medication. You will be monitored for at least 6 hours after||
2434|050|S|the first dose to make sure your heartbeat does not go too slow.||
2434|051|S|You may also need to be monitored if you restart this medication||
2434|052|S|or after a dosage increase (in children). Ask your doctor for||
2434|053|S|more details.||
2434|054|S|   Remember that this medication has been prescribed because your||
2434|055|S|doctor has judged that the benefit to you is greater than the||
2434|056|S|risk of side effects. Many people using this medication do not||
2434|057|S|have serious side effects.||
2434|058|S|   This medication may raise your blood pressure. Check your||
2434|059|S|blood pressure regularly and tell your doctor if the results are||
2434|060|S|high.||
2434|061|S|   Tell your doctor right away if you have any serious side||
2434|062|S|effects, including: signs of liver disease (such as||
2434|063|S|nausea/vomiting that doesn't stop, loss of appetite,||
2434|064|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2434|065|S|shortness of breath, unusual tiredness.||
2434|066|S|   Fingolimod may increase the risk of skin cancer and lymphoma.||
2434|067|S|Tell your doctor right away if you notice any new or changing||
2434|068|S|skin growths/moles, or swollen lymph nodes.||
2434|069|S|   This medication can weaken your immune system/increase the||
2434|070|S|risk of infection while you are taking it and for 2 months after||
2434|071|S|your last dose. You may be more likely to get a serious (possibly||
2434|072|S|fatal) infection (such as bronchitis, pneumonia, herpes). Tell||
2434|073|S|your doctor right away if you develop any signs of infection||
2434|074|S|(such as sore throat that doesn't go away, fever, chills, cough,||
2434|075|S|sores, or blisters). Do not start fingolimod if you already have||
2434|076|S|an infection.||
2434|077|S|   This medication may increase your risk of getting a rare but||
2434|078|S|very serious (possibly fatal) brain infection (progressive||
2434|079|S|multifocal leukoencephalopathy-PML). Symptoms of PML can seem||
2434|080|S|like a worsening MS attack. Get medical help right away if you||
2434|081|S|have any of these side effects: clumsiness, loss of||
2434|082|S|coordination/balance, weakness, sudden change in thinking (such||
2434|083|S|as confusion, difficulty concentrating, memory loss), difficulty||
2434|084|S|talking/walking, seizure.||
2434|085|S|   Get medical help right away if you have any very serious side||
2434|086|S|effects, including: very slow heartbeat, fast/irregular||
2434|087|S|heartbeat, severe dizziness, fainting, chest pain, eye||
2434|088|S|pain/sensitivity to light, vision changes (such as blurred||
2434|089|S|vision, blind spots/shadows in the center of your vision, color||
2434|090|S|changes), sudden/severe headache.||
2434|091|S|   A very serious allergic reaction to this drug is rare.||
2434|092|S|However, get medical help right away if you notice any symptoms||
2434|093|S|of a serious allergic reaction, including: rash, itching/swelling||
2434|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2434|095|S|breathing.||
2434|096|S|   This is not a complete list of possible side effects. If you||
2434|097|S|notice other effects not listed above, contact your doctor or||
2434|098|S|pharmacist.||
2434|099|S|   In the US -||
2434|100|S|   Call your doctor for medical advice about side effects. You||
2434|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2434|102|S|www.fda.gov/medwatch.||
2434|103|S|   In Canada - Call your doctor for medical advice about side||
2434|104|S|effects. You may report side effects to Health Canada at||
2434|105|S|1-866-234-2345.||
2434|106|B|||
2434|107|P|PRECAUTIONS:  Before taking fingolimod, tell your doctor or||
2434|108|P|pharmacist if you are allergic to it; or if you have any other||
2434|109|P|allergies. This product may contain inactive ingredients, which||
2434|110|P|can cause allergic reactions or other problems. Talk to your||
2434|111|P|pharmacist for more details.||
2434|112|P|   Before using this medication, tell your doctor or pharmacist||
2434|113|P|your medical history, especially of: heart problems (such as||
2434|114|P|slow/irregular heartbeat, heart failure, previous heart attack,||
2434|115|P|chest pain, QT prolongation in the EKG), family history of||
2434|116|P|certain heart problems (QT prolongation in the EKG, sudden||
2434|117|P|cardiac death), low levels of magnesium/potassium in the blood,||
2434|118|P|stroke/mini-stroke, high blood pressure, breathing problems (such||
2434|119|P|as asthma, bronchitis, emphysema, sleep apnea),||
2434|120|P|current/recent/returning infection (including hepatitis and||
2434|121|P|tuberculosis), diabetes, fainting, certain eye problems (macular||
2434|122|P|edema, uveitis), liver disease.||
2434|123|P|   Fingolimod can make you more likely to get infections or may||
2434|124|P|make current infections worse. Stay away from anyone who has an||
2434|125|P|infection that may easily spread (such as chickenpox, COVID-19,||
2434|126|P|measles, flu). Talk to your doctor if you have been exposed to an||
2434|127|P|infection or for more details.||
2434|128|P|   Tell your doctor your vaccine history and ask if you need to||
2434|129|P|get any vaccines before starting treatment with this medication.||
2434|130|P|Tell your health care professional that you are using fingolimod||
2434|131|P|before having any immunizations/vaccinations. Avoid getting a||
2434|132|P|live vaccine for 2 months after the last dose of this medication.||
2434|133|P|Avoid contact with people who have recently received live||
2434|134|P|vaccines (such as flu vaccine inhaled through the nose).||
2434|135|P|   This medication may increase your risk of developing skin||
2434|136|P|cancer. Limit your time in the sun. Avoid tanning booths and||
2434|137|P|sunlamps. Use sunscreen and wear protective clothing when||
2434|138|P|outdoors. Your doctor may direct you to avoid phototherapy while||
2434|139|P|you use this product. Ask your doctor for details.||
2434|140|P|   Before having surgery, tell your doctor or dentist about all||
2434|141|P|the products you use (including prescription drugs,||
2434|142|P|nonprescription drugs, and herbal products).||
2434|143|P|   Tell your doctor if you are pregnant or plan to become||
2434|144|P|pregnant. You should not become pregnant while using fingolimod.||
2434|145|P|Fingolimod may harm an unborn baby. Your doctor should order a||
2434|146|P|pregnancy test before you start this medication. Ask about||
2434|147|P|reliable forms of birth control while using this medication and||
2434|148|P|for 2 months after the last dose. If you become pregnant, talk to||
2434|149|P|your doctor right away about the risks and benefits of this||
2434|150|P|medication.||
2434|151|P|   It is unknown if this drug passes into breast milk. Because of||
2434|152|P|the possible risk to the infant, breastfeeding is not recommended||
2434|153|P|while using this drug. Consult your doctor before breastfeeding.||
2434|154|B|||
2434|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2434|156|I|medications work or increase your risk for serious side effects.||
2434|157|I|This document does not contain all possible drug interactions.||
2434|158|I|Keep a list of all the products you use (including||
2434|159|I|prescription/nonprescription drugs and herbal products) and share||
2434|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
2434|161|I|the dosage of any medicines without your doctor's approval.||
2434|162|I|   Some products that may interact with this drug are: drugs that||
2434|163|I|slow down your heartbeat (including digoxin, beta-blockers such||
2434|164|I|as atenolol/metoprolol, calcium channel blockers such as||
2434|165|I|diltiazem/verapamil), certain drugs for irregular heartbeat (such||
2434|166|I|as amiodarone, disopyramide, dofetilide, dronedarone, ibutilide,||
2434|167|I|procainamide, quinidine, sotalol), other drugs that weaken the||
2434|168|I|immune system/increase the risk of infection (such as||
2434|169|I|natalizumab, rituximab).||
2434|170|B|||
2434|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2434|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2434|173|O|poison control center right away. US residents can call||
2434|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2434|175|B|||
2434|176|N|NOTES:  Do not share this medication with others.||
2434|177|N|   Lab and/or medical tests (such as complete blood count, blood||
2434|178|N|pressure, pulse, EKG, MRI, eye/skin exams, liver/lung function,||
2434|179|N|Pap smear) should be done before you start taking this medication||
2434|180|N|and while you are taking it. Keep all medical and lab||
2434|181|N|appointments. Consult your doctor for more details.||
2434|182|B|||
2434|183|D|MISSED DOSE:  It is very important to follow your treatment||
2434|184|D|regimen exactly. Ask your doctor ahead of time what you should do||
2434|185|D|if you miss a dose of fingolimod. Do not double the dose to catch||
2434|186|D|up.||
2434|187|B|||
2434|188|R|STORAGE:  Store at room temperature away from light and moisture.||
2434|189|R|Keep the tablets in the original packaging until ready to use. Do||
2434|190|R|not store in the bathroom. Keep all medications away from||
2434|191|R|children and pets.||
2434|192|R|   Do not flush medications down the toilet or pour them into a||
2434|193|R|drain unless instructed to do so. Properly discard this product||
2434|194|R|when it is expired or no longer needed. Consult your pharmacist||
2434|195|R|or local waste disposal company.||
2434|196|B|||
2434|197|A|Information last revised April 2025.||
2434|198|A|Copyright(c) 2025 First Databank, Inc.||
2434|199|B|||
2435|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2435|002|Z|does NOT have all possible information about this product. This||
2435|003|Z|information does not assure that this product is safe, effective,||
2435|004|Z|or appropriate for you. This information is not individual||
2435|005|Z|medical advice and does not substitute for the advice of your||
2435|006|Z|health care professional. Always ask your health care||
2435|007|Z|professional for complete information about this product and your||
2435|008|Z|specific health needs.||
2435|009|B|||
2435|010|T|FINASTERIDE/TADALAFIL - ORAL||
2435|011|F|(fin-AS-ter-ide/ ta-DA-la-fil)||
2435|012|B|||
2435|013|C|COMMON BRAND NAME(S): Entadfi||
2435|014|B|||
2435|015|U|USES:  This combination medication contains 2 drugs: finasteride||
2435|016|U|and tadalafil. It is used to treat signs and symptoms of an||
2435|017|U|enlarged prostate (benign prostatic hyperplasia-BPH). This||
2435|018|U|medication may help shrink an enlarged prostate and lessen||
2435|019|U|symptoms of BPH such as difficulty starting urination, weak||
2435|020|U|stream, feeling that the bladder is not completely emptied, and||
2435|021|U|frequent urge to urinate (including at night). Finasteride works||
2435|022|U|by decreasing the amount of a natural body hormone (DHT) that||
2435|023|U|causes growth of the prostate. Tadalafil is thought to work by||
2435|024|U|relaxing muscles in the prostate and bladder.||
2435|025|U|   Women and children should not use this medication.||
2435|026|B|||
2435|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2435|028|H|from your pharmacist before you start taking||
2435|029|H|finasteride/tadalafil and each time you get a refill. If you have||
2435|030|H|any questions, ask your doctor or pharmacist.||
2435|031|H|   Take this medication by mouth without food as directed by your||
2435|032|H|doctor, usually once a day. Since the benefit of taking||
2435|033|H|finasteride with tadalafil for BPH may lessen over time, this||
2435|034|H|medication is not recommended to be taken for longer than 26||
2435|035|H|weeks. Talk to your doctor for details.||
2435|036|H|   Use this medication regularly to get the most benefit from it.||
2435|037|H|To help you remember, take it at the same time each day.||
2435|038|H|   Since this drug can be absorbed through the skin and lungs and||
2435|039|H|may harm an unborn baby, women who are pregnant or who may become||
2435|040|H|pregnant should not handle this medication or breathe the dust||
2435|041|H|from the capsules. It may cause abnormal sex organ development in||
2435|042|H|an unborn male infant.||
2435|043|H|   Tell your doctor if your condition does not get better or if||
2435|044|H|it gets worse.||
2435|045|B|||
2435|046|S|SIDE EFFECTS:  Decreased sex drive, trouble getting or keeping an||
2435|047|S|erection, or decreased amount of semen during sex may occur.||
2435|048|S|Headache, upset stomach, back pain, muscle pain, stuffy nose,||
2435|049|S|flushing, or dizziness may also occur. If any of these effects||
2435|050|S|last or get worse, tell your doctor or pharmacist promptly.||
2435|051|S|   To reduce the risk of dizziness and lightheadedness, get up||
2435|052|S|slowly when rising from a sitting or lying position.||
2435|053|S|   Remember that this medication has been prescribed because your||
2435|054|S|doctor has judged that the benefit to you is greater than the||
2435|055|S|risk of side effects. Many people using this medication do not||
2435|056|S|have serious side effects.||
2435|057|S|   Tell your doctor right away if you have any serious side||
2435|058|S|effects, including: breast changes (such as enlargement, lumps,||
2435|059|S|pain, nipple discharge), pain in the testicles, color vision||
2435|060|S|changes.||
2435|061|S|   Sexual activity may put extra strain on your heart, especially||
2435|062|S|if you have heart problems. If you have heart problems and||
2435|063|S|experience any of these serious side effects while having sex,||
2435|064|S|stop and get medical help right away: chest/jaw/left arm pain,||
2435|065|S|shortness of breath, dizziness, nausea.||
2435|066|S|   Rarely, sudden decreased vision, or even permanent blindness,||
2435|067|S|may occur in one or both eyes (NAION). If this serious problem||
2435|068|S|occurs, stop taking this medication and get medical help right||
2435|069|S|away. You have a slightly greater chance of developing NAION if||
2435|070|S|you have heart disease, diabetes, high cholesterol, certain other||
2435|071|S|eye problems ("crowded disk"), high blood pressure, if you are||
2435|072|S|over 50, or if you smoke.||
2435|073|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
2435|074|S|ringing in the ears and dizziness, may occur. Stop taking this||
2435|075|S|medication and get medical help right away if these effects||
2435|076|S|occur.||
2435|077|S|   Rarely, males may have a painful or prolonged erection lasting||
2435|078|S|4 or more hours. If this occurs, stop using this drug and get||
2435|079|S|medical help right away, or permanent problems could occur.||
2435|080|S|   A very serious allergic reaction to this drug is rare.||
2435|081|S|However, get medical help right away if you notice any symptoms||
2435|082|S|of a serious allergic reaction, including: rash, itching/swelling||
2435|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2435|084|S|breathing.||
2435|085|S|   This is not a complete list of possible side effects. If you||
2435|086|S|notice other effects not listed above, contact your doctor or||
2435|087|S|pharmacist.||
2435|088|S|   In the US -||
2435|089|S|   Call your doctor for medical advice about side effects. You||
2435|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2435|091|S|www.fda.gov/medwatch.||
2435|092|S|   In Canada - Call your doctor for medical advice about side||
2435|093|S|effects. You may report side effects to Health Canada at||
2435|094|S|1-866-234-2345.||
2435|095|B|||
2435|096|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2435|097|P|pharmacist if you are allergic to finasteride or tadalafil; or if||
2435|098|P|you have any other allergies. This product may contain inactive||
2435|099|P|ingredients, which can cause allergic reactions or other||
2435|100|P|problems. Talk to your pharmacist for more details.||
2435|101|P|   Before using this medication, tell your doctor or pharmacist||
2435|102|P|your medical history, especially of: heart problems (such as||
2435|103|P|angina, heart failure, irregular heartbeat, previous heart||
2435|104|P|attack), bleeding problems, high or low blood pressure, kidney||
2435|105|P|disease, liver disease, stomach ulcers, stroke, penis conditions||
2435|106|P|(such as angulation, Peyronie's disease), painful/prolonged||
2435|107|P|erection (priapism), conditions that may increase the risk of||
2435|108|P|priapism (such as sickle cell anemia, multiple myeloma,||
2435|109|P|leukemia), prostate cancer, eye problems (such as retinitis||
2435|110|P|pigmentosa, sudden decreased vision, NAION).||
2435|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2435|112|P|can make you more dizzy. Do not drive, use machinery, or do||
2435|113|P|anything that needs alertness until you can do it safely. Limit||
2435|114|P|alcoholic beverages. Talk to your doctor if you are using||
2435|115|P|marijuana (cannabis).||
2435|116|P|   Before having surgery, tell your doctor or dentist about all||
2435|117|P|the products you use (including prescription drugs,||
2435|118|P|nonprescription drugs, and herbal products).||
2435|119|P|   Finasteride should not be used by women, especially during||
2435|120|P|pregnancy or breastfeeding. It may harm an unborn or||
2435|121|P|breastfeeding baby. Consult your doctor if you have any||
2435|122|P|questions.||
2435|123|B|||
2435|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2435|125|I|medications work or increase your risk for serious side effects.||
2435|126|I|This document does not contain all possible drug interactions.||
2435|127|I|Keep a list of all the products you use (including||
2435|128|I|prescription/nonprescription drugs and herbal products) and share||
2435|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
2435|130|I|the dosage of any medicines without your doctor's approval.||
2435|131|I|   Some products that may interact with this drug are: alpha||
2435|132|I|blocker medication (such as doxazosin, tamsulosin), nitrates||
2435|133|I|(such as nitroglycerin, isosorbide), recreational drugs called||
2435|134|I|"poppers" that contain amyl or butyl nitrite, riociguat,||
2435|135|I|vericiguat.||
2435|136|I|   Other medications can affect the removal of||
2435|137|I|finasteride/tadalafil from your body, which may affect how this||
2435|138|I|medication works. Examples include azole antifungals (such as||
2435|139|I|itraconazole, ketoconazole), macrolide antibiotics (such as||
2435|140|I|clarithromycin, erythromycin), HIV protease inhibitors (such as||
2435|141|I|fosamprenavir), rifampin, ritonavir, among others.||
2435|142|I|   Do not take this medication with any other product that||
2435|143|I|contains tadalafil or other similar medications for erectile||
2435|144|I|dysfunction-ED or pulmonary hypertension (such as sildenafil,||
2435|145|I|vardenafil).||
2435|146|I|   This medication may interfere with certain lab tests (such as||
2435|147|I|PSA levels), possibly causing false test results. Make sure lab||
2435|148|I|personnel and all your doctors know you use this drug.||
2435|149|B|||
2435|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2435|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2435|152|O|poison control center right away. US residents can call||
2435|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2435|154|B|||
2435|155|N|NOTES:  Do not share this medication with others.||
2435|156|N|   Lab and/or medical tests (such as blood pressure, prostate||
2435|157|N|exams, PSA levels) should be done while you are taking this||
2435|158|N|medication. Keep all medical and lab appointments. Follow your||
2435|159|N|doctor's instructions for examining your breasts and testicles,||
2435|160|N|and report any lumps right away.||
2435|161|B|||
2435|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2435|163|D|remember. If it is near the time of the next dose, skip the||
2435|164|D|missed dose. Take your next dose at the regular time. Do not||
2435|165|D|double the dose to catch up.||
2435|166|B|||
2435|167|R|STORAGE:  Store at room temperature away from light and moisture.||
2435|168|R|Do not store in the bathroom. Keep all medications away from||
2435|169|R|children and pets.||
2435|170|R|   Do not flush medications down the toilet or pour them into a||
2435|171|R|drain unless instructed to do so. Properly discard this product||
2435|172|R|when it is expired or no longer needed. Consult your pharmacist||
2435|173|R|or local waste disposal company.||
2435|174|B|||
2435|175|A|Information last revised August 2025.||
2435|176|A|Copyright(c) 2025 First Databank, Inc.||
2435|177|B|||
2436|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2436|002|Z|does NOT have all possible information about this product. This||
2436|003|Z|information does not assure that this product is safe, effective,||
2436|004|Z|or appropriate for you. This information is not individual||
2436|005|Z|medical advice and does not substitute for the advice of your||
2436|006|Z|health care professional. Always ask your health care||
2436|007|Z|professional for complete information about this product and your||
2436|008|Z|specific health needs.||
2436|009|B|||
2436|010|T|ACALABRUTINIB TABLET - ORAL||
2436|011|F|(a-KAL-a-BROO-ti-nib)||
2436|012|B|||
2436|013|C|COMMON BRAND NAME(S): Calquence||
2436|014|B|||
2436|015|U|USES:  This medication is used to treat certain types of cancer||
2436|016|U|(such as mantle cell lymphoma, small lymphocytic lymphoma - SLL,||
2436|017|U|chronic lymphocytic leukemia - CLL). Acalabrutinib works by||
2436|018|U|slowing or stopping the growth of cancer cells. It belongs to a||
2436|019|U|class of drugs known as kinase inhibitors.||
2436|020|B|||
2436|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2436|022|H|from your pharmacist before you start using acalabrutinib and||
2436|023|H|each time you get a refill. If you have any questions, ask your||
2436|024|H|doctor or pharmacist.||
2436|025|H|   Take this medication by mouth with or without food as directed||
2436|026|H|by your doctor, usually two times a day (about 12 hours apart).||
2436|027|H|Swallow the tablet whole with a full glass of water (8 ounces/240||
2436|028|H|milliliters). Do not chew, crush, dissolve, or cut the tablets.||
2436|029|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2436|030|H|using this medication unless your doctor or pharmacist says you||
2436|031|H|may do so safely. Grapefruit can increase the chance of side||
2436|032|H|effects with this medicine. Ask your doctor or pharmacist for||
2436|033|H|more details.||
2436|034|H|   The dosage is based on your medical condition, response to||
2436|035|H|treatment, and other medications you may be taking. Be sure to||
2436|036|H|tell your doctor and pharmacist about all the products you use||
2436|037|H|(including prescription drugs, nonprescription drugs, and herbal||
2436|038|H|products).||
2436|039|H|   Do not increase your dose or use this drug more often or for||
2436|040|H|longer than prescribed. Your condition will not improve any||
2436|041|H|faster, and your risk of serious side effects will increase.||
2436|042|H|   Take this medication regularly to get the most benefit from||
2436|043|H|it. To help you remember, take it at the same times each day.||
2436|044|H|   Since this drug can be absorbed through the skin and lungs and||
2436|045|H|may harm an unborn baby, women who are pregnant or who may become||
2436|046|H|pregnant should not handle this medication or breathe the dust||
2436|047|H|from the tablets.||
2436|048|B|||
2436|049|S|SIDE EFFECTS:  Headache, nausea, vomiting, diarrhea, tiredness,||
2436|050|S|dizziness, or muscle aches may occur. If any of these effects||
2436|051|S|last or get worse, tell your doctor or pharmacist promptly.||
2436|052|S|   Remember that this medication has been prescribed because your||
2436|053|S|doctor has judged that the benefit to you is greater than the||
2436|054|S|risk of side effects. Many people using this medication do not||
2436|055|S|have serious side effects.||
2436|056|S|   Tell your doctor right away if you have any serious side||
2436|057|S|effects, including: unusual tiredness, easy or unusual bruising||
2436|058|S|or bleeding (such as nose/gum bleeds, pink/dark urine,||
2436|059|S|black/bloody stools, vomit that contains blood or looks like||
2436|060|S|coffee grounds), signs of heart problems (such as fast/irregular||
2436|061|S|heartbeat, fainting, shortness of breath, chest discomfort),||
2436|062|S|signs of liver disease (such as nausea/vomiting that doesn't||
2436|063|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
2436|064|S|eyes/skin, dark urine).||
2436|065|S|   Get medical help right away if you have any very serious side||
2436|066|S|effects, including: weakness on one side of the body, trouble||
2436|067|S|speaking, vision changes, confusion.||
2436|068|S|   This medication may lower your ability to fight infections.||
2436|069|S|This may make you more likely to get a serious (rarely fatal)||
2436|070|S|infection or make any infection you have worse. Tell your doctor||
2436|071|S|right away if you have any signs of infection (such as sore||
2436|072|S|throat that doesn't go away, fever, chills).||
2436|073|S|   Although acalabrutinib is used to treat cancer, it may rarely||
2436|074|S|increase your risk of developing other cancers (such as skin||
2436|075|S|cancer). Tell your doctor right away if you develop unusual||
2436|076|S|growths or lumps, swollen lymph nodes, sudden weight loss, night||
2436|077|S|sweats, change in appearance or size of moles, or unusual skin||
2436|078|S|changes/growth (see also Precautions section).||
2436|079|S|   A very serious allergic reaction to this drug is rare.||
2436|080|S|However, get medical help right away if you notice any symptoms||
2436|081|S|of a serious allergic reaction, including: rash, itching/swelling||
2436|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2436|083|S|breathing.||
2436|084|S|   This is not a complete list of possible side effects. If you||
2436|085|S|notice other effects not listed above, contact your doctor or||
2436|086|S|pharmacist.||
2436|087|S|   In the US -||
2436|088|S|   Call your doctor for medical advice about side effects. You||
2436|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2436|090|S|www.fda.gov/medwatch.||
2436|091|S|   In Canada - Call your doctor for medical advice about side||
2436|092|S|effects. You may report side effects to Health Canada at||
2436|093|S|1-866-234-2345.||
2436|094|B|||
2436|095|P|PRECAUTIONS:  Before taking acalabrutinib, tell your doctor or||
2436|096|P|pharmacist if you are allergic to it; or if you have any other||
2436|097|P|allergies. This product may contain inactive ingredients, which||
2436|098|P|can cause allergic reactions or other problems. Talk to your||
2436|099|P|pharmacist for more details.||
2436|100|P|   Before using this medication, tell your doctor or pharmacist||
2436|101|P|your medical history, especially of: bleeding/blood problems||
2436|102|P|(such as ulcers), fast/irregular heartbeat, recent/current||
2436|103|P|infection (including hepatitis, HIV infection), liver disease.||
2436|104|P|   This medication may increase your risk for other cancers,||
2436|105|P|including skin cancer. Limit your time in the sun. Avoid tanning||
2436|106|P|booths and sunlamps. Use sunscreen and wear protective clothing||
2436|107|P|when outdoors.||
2436|108|P|   Acalabrutinib can make you more likely to get infections or||
2436|109|P|may make current infections worse. Stay away from anyone who has||
2436|110|P|an infection that may easily spread (such as chickenpox,||
2436|111|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2436|112|P|exposed to an infection or for more details.||
2436|113|P|   Tell your health care professional that you are using||
2436|114|P|acalabrutinib before having any immunizations/vaccinations. Avoid||
2436|115|P|contact with people who have recently received live vaccines||
2436|116|P|(such as flu vaccine inhaled through the nose).||
2436|117|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2436|118|P|can make you more dizzy. Do not drive, use machinery, or do||
2436|119|P|anything that needs alertness until you can do it safely. Limit||
2436|120|P|alcoholic beverages. Talk to your doctor if you are using||
2436|121|P|marijuana (cannabis).||
2436|122|P|   Before having surgery, tell your doctor or dentist about all||
2436|123|P|the products you use (including prescription drugs,||
2436|124|P|nonprescription drugs, and herbal products).||
2436|125|P|   Older adults may be more sensitive to the side effects of this||
2436|126|P|drug.||
2436|127|P|   Since this drug can be absorbed through the skin and lungs and||
2436|128|P|may harm an unborn baby, women who are pregnant or who may become||
2436|129|P|pregnant should not handle this medication or breathe the dust||
2436|130|P|from the tablets.||
2436|131|P|   Tell your doctor if you are pregnant or plan to become||
2436|132|P|pregnant. You should not become pregnant while using||
2436|133|P|acalabrutinib. Acalabrutinib may harm an unborn baby. Your doctor||
2436|134|P|should order a pregnancy test before you start this medication.||
2436|135|P|Ask about reliable forms of birth control while using this||
2436|136|P|medication and for at least one week after the last dose. If you||
2436|137|P|become pregnant, talk to your doctor right away about the risks||
2436|138|P|and benefits of this medication.||
2436|139|P|   It is unknown if this drug passes into breast milk. Because of||
2436|140|P|the possible risk to the infant, breastfeeding is not recommended||
2436|141|P|while using this drug and for at least 2 weeks after the last||
2436|142|P|dose. Consult your doctor before breastfeeding.||
2436|143|B|||
2436|144|I|DRUG INTERACTIONS:  See also How to Use section.||
2436|145|I|   Drug interactions may change how your medications work or||
2436|146|I|increase your risk for serious side effects. This document does||
2436|147|I|not contain all possible drug interactions. Keep a list of all||
2436|148|I|the products you use (including prescription/nonprescription||
2436|149|I|drugs and herbal products) and share it with your doctor and||
2436|150|I|pharmacist. Do not start, stop, or change the dosage of any||
2436|151|I|medicines without your doctor's approval.||
2436|152|I|   Other medications can affect the removal of acalabrutinib from||
2436|153|I|your body, which may affect how acalabrutinib works. Examples||
2436|154|I|include azole antifungals (such as ketoconazole, itraconazole,||
2436|155|I|voriconazole), macrolide antibiotics (such as clarithromycin,||
2436|156|I|erythromycin), HIV protease inhibitors (such as atazanavir,||
2436|157|I|nelfinavir), drugs to treat seizures (such as phenytoin,||
2436|158|I|carbamazepine, phenobarbital), nefazodone, ritonavir, St. John's||
2436|159|I|wort, telithromycin, among others.||
2436|160|B|||
2436|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2436|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2436|163|O|poison control center right away. US residents can call||
2436|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2436|165|B|||
2436|166|N|NOTES:  Do not share this medication with others.||
2436|167|N|   Lab and/or medical tests (such as liver function, complete||
2436|168|N|blood counts) should be done before you start taking this||
2436|169|N|medication and while you are taking it. Keep all medical and lab||
2436|170|N|appointments.||
2436|171|B|||
2436|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2436|173|D|remember. If it is more than 3 hours after the missed dose, skip||
2436|174|D|the missed dose. Take your next dose at the regular time. Do not||
2436|175|D|double the dose to catch up.||
2436|176|B|||
2436|177|R|STORAGE:  Store at room temperature away from light and moisture.||
2436|178|R|Do not store in the bathroom. Keep all medications away from||
2436|179|R|children and pets.||
2436|180|R|   Do not flush medications down the toilet or pour them into a||
2436|181|R|drain unless instructed to do so. Properly discard this product||
2436|182|R|when it is expired or no longer needed. Consult your pharmacist||
2436|183|R|or local waste disposal company.||
2436|184|B|||
2436|185|M|MEDICAL ALERT:  Your condition can cause complications in a||
2436|186|M|medical emergency. For information about enrolling in MedicAlert,||
2436|187|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2436|188|B|||
2436|189|A|Information last revised May 2025.||
2436|190|A|Copyright(c) 2025 First Databank, Inc.||
2436|191|B|||
2437|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2437|002|Z|does NOT have all possible information about this product. This||
2437|003|Z|information does not assure that this product is safe, effective,||
2437|004|Z|or appropriate for you. This information is not individual||
2437|005|Z|medical advice and does not substitute for the advice of your||
2437|006|Z|health care professional. Always ask your health care||
2437|007|Z|professional for complete information about this product and your||
2437|008|Z|specific health needs.||
2437|009|B|||
2437|010|T|ROFLUMILAST 0.3% CREAM - TOPICAL||
2437|011|F|(roe-FLUE-mi-last)||
2437|012|B|||
2437|013|C|COMMON BRAND NAME(S): Zoryve||
2437|014|B|||
2437|015|U|USES:  This medication is used to treat a certain skin condition||
2437|016|U|(plaque psoriasis). Roflumilast may help to reduce the redness,||
2437|017|U|thickening, and scaling of the skin that occurs with this||
2437|018|U|condition.||
2437|019|B|||
2437|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2437|021|H|from your pharmacist before you start using roflumilast and each||
2437|022|H|time you get a refill. If you have any questions, ask your doctor||
2437|023|H|or pharmacist.||
2437|024|H|   This medication is for use on the skin only. Apply this||
2437|025|H|medication to the affected area and rub in completely as directed||
2437|026|H|by your doctor, usually once daily. Wash your hands after||
2437|027|H|applying, unless you are treating your hands. Avoid getting this||
2437|028|H|medication in your eyes, mouth, or vagina. If this happens, rinse||
2437|029|H|right away with plenty of water.||
2437|030|H|   Use this medication regularly to get the most benefit from it.||
2437|031|H|To help you remember, use it at the same time each day.||
2437|032|H|   Tell your doctor if your condition does not get better or if||
2437|033|H|it gets worse.||
2437|034|B|||
2437|035|S|SIDE EFFECTS:  Diarrhea, nausea, headache, or pain at the||
2437|036|S|application site may occur. If any of these effects last or get||
2437|037|S|worse, tell your doctor or pharmacist promptly.||
2437|038|S|   Remember that this medication has been prescribed because your||
2437|039|S|doctor has judged that the benefit to you is greater than the||
2437|040|S|risk of side effects. Many people using this medication do not||
2437|041|S|have serious side effects.||
2437|042|S|   Tell your doctor right away if you have any serious side||
2437|043|S|effects, including: trouble sleeping, signs of infection (such as||
2437|044|S|sore throat that doesn't go away, fever, chills).||
2437|045|S|   A very serious allergic reaction to this drug is rare.||
2437|046|S|However, get medical help right away if you notice any symptoms||
2437|047|S|of a serious allergic reaction, including: rash, itching/swelling||
2437|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2437|049|S|breathing.||
2437|050|S|   This is not a complete list of possible side effects. If you||
2437|051|S|notice other effects not listed above, contact your doctor or||
2437|052|S|pharmacist.||
2437|053|S|   In the US -||
2437|054|S|   Call your doctor for medical advice about side effects. You||
2437|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2437|056|S|www.fda.gov/medwatch.||
2437|057|S|   In Canada - Call your doctor for medical advice about side||
2437|058|S|effects. You may report side effects to Health Canada at||
2437|059|S|1-866-234-2345.||
2437|060|B|||
2437|061|P|PRECAUTIONS:  Before using roflumilast, tell your doctor or||
2437|062|P|pharmacist if you are allergic to it; or if you have any other||
2437|063|P|allergies. This product may contain inactive ingredients, which||
2437|064|P|can cause allergic reactions or other problems. Talk to your||
2437|065|P|pharmacist for more details.||
2437|066|P|   Before using this medication, tell your doctor or pharmacist||
2437|067|P|your medical history, especially of: liver disease.||
2437|068|P|   Before having surgery, tell your doctor or dentist about all||
2437|069|P|the products you use (including prescription drugs,||
2437|070|P|nonprescription drugs, and herbal products).||
2437|071|P|   During pregnancy, this medication should be used only when||
2437|072|P|clearly needed. Discuss the risks and benefits with your doctor.||
2437|073|P|   It is unknown if this medication passes into breast milk.||
2437|074|P|Consult your doctor before breastfeeding.||
2437|075|B|||
2437|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2437|077|I|medications work or increase your risk for serious side effects.||
2437|078|I|This document does not contain all possible drug interactions.||
2437|079|I|Keep a list of all the products you use (including||
2437|080|I|prescription/nonprescription drugs and herbal products) and share||
2437|081|I|it with your doctor and pharmacist. Do not start, stop, or change||
2437|082|I|the dosage of any medicines without your doctor's approval.||
2437|083|B|||
2437|084|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2437|085|O|has overdosed and has serious symptoms such as passing out or||
2437|086|O|trouble breathing, call 911. Otherwise, call a poison control||
2437|087|O|center right away. US residents can call 1-800-222-1222. Canada||
2437|088|O|residents can call 1-844-764-7669.||
2437|089|B|||
2437|090|N|NOTES:  Do not share this medication with others.||
2437|091|B|||
2437|092|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
2437|093|D|remember. If it is near the time of the next dose, skip the||
2437|094|D|missed dose. Apply your next dose at the regular time. Do not||
2437|095|D|apply extra medicine to make up for the missed dose.||
2437|096|B|||
2437|097|R|STORAGE:  Store at room temperature. Keep all medications away||
2437|098|R|from children and pets.||
2437|099|R|   Do not flush medications down the toilet or pour them into a||
2437|100|R|drain unless instructed to do so. Properly discard this product||
2437|101|R|when it is expired or no longer needed. Consult your pharmacist||
2437|102|R|or local waste disposal company.||
2437|103|B|||
2437|104|A|Information last revised October 2024.||
2437|105|A|Copyright(c) 2025 First Databank, Inc.||
2437|106|B|||
2438|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2438|002|Z|does NOT have all possible information about this product. This||
2438|003|Z|information does not assure that this product is safe, effective,||
2438|004|Z|or appropriate for you. This information is not individual||
2438|005|Z|medical advice and does not substitute for the advice of your||
2438|006|Z|health care professional. Always ask your health care||
2438|007|Z|professional for complete information about this product and your||
2438|008|Z|specific health needs.||
2438|009|B|||
2438|010|T|SODIUM PHENYLBUTYRATE/TAURURSODIOL (URSODOXICOLTAURINE) - ORAL||
2438|011|F|(SOE-dee-um FEN-il-BUE-ti-rate/taur-UR-so-DYE-ol)||
2438|012|B|||
2438|013|C|COMMON BRAND NAME(S): Relyvrio||
2438|014|B|||
2438|015|U|USES:  This medication is used to treat a certain type of nerve||
2438|016|U|disease called amyotrophic lateral sclerosis (ALS, also commonly||
2438|017|U|called Lou Gehrig's disease). This medication contains 2 drugs:||
2438|018|U|sodium phenylbutyrate and taurursodiol (also known as||
2438|019|U|ursodoxicoltaurine). It helps slow down loss of physical function||
2438|020|U|due to this disease. However, it is not a cure for ALS, and it||
2438|021|U|does not reverse nerve damage or muscle weakness.||
2438|022|B|||
2438|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2438|024|H|from your pharmacist before you start using this medication and||
2438|025|H|each time you get a refill. If you have any questions, ask your||
2438|026|H|doctor or pharmacist.||
2438|027|H|   Take this medication by mouth or through a feeding tube before||
2438|028|H|a meal or a snack as directed by your doctor, usually once a day||
2438|029|H|for the first 3 weeks, then twice a day from then on. This||
2438|030|H|medication must be mixed before taking. Open 1 sachet and mix all||
2438|031|H|of the contents in a cup (8 ounces or 250 milliliters) of room||
2438|032|H|temperature water. Stir well, and take the mixture within 1 hour||
2438|033|H|after mixing.||
2438|034|H|   The dosage is based on your medical condition and response to||
2438|035|H|treatment. To reduce your risk of side effects, your doctor may||
2438|036|H|direct you to start this medication at a low dose and gradually||
2438|037|H|increase your dose. Follow your doctor's instructions carefully.||
2438|038|H|   Use this medication regularly to get the most benefit from it.||
2438|039|H|To help you remember, take it at the same time(s) each day.||
2438|040|B|||
2438|041|S|SIDE EFFECTS:  Nausea, diarrhea, decreased appetite,||
2438|042|S|stomach/abdominal pain, dizziness, drowsiness, or tiredness may||
2438|043|S|occur. If any of these effects last or get worse, tell your||
2438|044|S|doctor or pharmacist promptly.||
2438|045|S|   Remember that this medication has been prescribed because your||
2438|046|S|doctor has judged that the benefit to you is greater than the||
2438|047|S|risk of side effects. Many people using this medication do not||
2438|048|S|have serious side effects.||
2438|049|S|   A very serious allergic reaction to this drug is rare.||
2438|050|S|However, get medical help right away if you notice any symptoms||
2438|051|S|of a serious allergic reaction, including: rash, itching/swelling||
2438|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2438|053|S|breathing.||
2438|054|S|   This is not a complete list of possible side effects. If you||
2438|055|S|notice other effects not listed above, contact your doctor or||
2438|056|S|pharmacist.||
2438|057|S|   In the US -||
2438|058|S|   Call your doctor for medical advice about side effects. You||
2438|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2438|060|S|www.fda.gov/medwatch.||
2438|061|S|   In Canada - Call your doctor for medical advice about side||
2438|062|S|effects. You may report side effects to Health Canada at||
2438|063|S|1-866-234-2345.||
2438|064|B|||
2438|065|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2438|066|P|pharmacist if you are allergic to sodium phenylbutyrate or||
2438|067|P|taurursodiol (ursodoxicoltaurine); or to bile salts; or if you||
2438|068|P|have any other allergies. This product may contain inactive||
2438|069|P|ingredients, which can cause allergic reactions or other||
2438|070|P|problems. Talk to your pharmacist for more details.||
2438|071|P|   Before using this medication, tell your doctor or pharmacist||
2438|072|P|your medical history, especially of: heart problems (such as||
2438|073|P|heart failure), kidney problems, liver problems, swelling||
2438|074|P|(edema), digestive problems, problems with your pancreas, a||
2438|075|P|certain inherited condition (glucose-galactose malabsorption).||
2438|076|P|   This medication contains salt (sodium). Before taking this||
2438|077|P|medication, tell your doctor or pharmacist if you are on a||
2438|078|P|low-salt diet.||
2438|079|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2438|080|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2438|081|P|machinery, or do anything that needs alertness until you can do||
2438|082|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2438|083|P|are using marijuana (cannabis).||
2438|084|P|   Before having surgery, tell your doctor or dentist about all||
2438|085|P|the products you use (including prescription drugs,||
2438|086|P|nonprescription drugs, and herbal products).||
2438|087|P|   During pregnancy, this medication should be used only when||
2438|088|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2438|089|P|benefits with your doctor.||
2438|090|P|   It is unknown if this medication passes into breast milk.||
2438|091|P|Consult your doctor before breastfeeding.||
2438|092|B|||
2438|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2438|094|I|medications work or increase your risk for serious side effects.||
2438|095|I|This document does not contain all possible drug interactions.||
2438|096|I|Keep a list of all the products you use (including||
2438|097|I|prescription/nonprescription drugs and herbal products) and share||
2438|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
2438|099|I|the dosage of any medicines without your doctor's approval.||
2438|100|I|   Some products that may interact with this drug are:||
2438|101|I|aluminum-containing antacids, bile acid-binding resins (such as||
2438|102|I|cholestyramine, colestipol, colesevelam).||
2438|103|B|||
2438|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2438|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2438|106|O|poison control center right away. US residents can call||
2438|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2438|108|B|||
2438|109|N|NOTES:  Do not share this medication with others.||
2438|110|N|   Lab and/or medical tests may be done while you are taking this||
2438|111|N|medication. Keep all medical and lab appointments.||
2438|112|B|||
2438|113|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2438|114|D|next dose at the regular time. Do not take more or double the||
2438|115|D|dose to catch up.||
2438|116|B|||
2438|117|R|STORAGE:  Store at room temperature away from light and moisture.||
2438|118|R|Do not store in the bathroom. Keep all medications away from||
2438|119|R|children and pets.||
2438|120|R|   Do not flush medications down the toilet or pour them into a||
2438|121|R|drain unless instructed to do so. Properly discard this product||
2438|122|R|when it is expired or no longer needed. Consult your pharmacist||
2438|123|R|or local waste disposal company.||
2438|124|B|||
2438|125|A|Information last revised May 2024.||
2438|126|A|Copyright(c) 2025 First Databank, Inc.||
2438|127|B|||
2439|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2439|002|Z|does NOT have all possible information about this product. This||
2439|003|Z|information does not assure that this product is safe, effective,||
2439|004|Z|or appropriate for you. This information is not individual||
2439|005|Z|medical advice and does not substitute for the advice of your||
2439|006|Z|health care professional. Always ask your health care||
2439|007|Z|professional for complete information about this product and your||
2439|008|Z|specific health needs.||
2439|009|B|||
2439|010|T|CLINDAMYCIN SINGLE DOSE GEL - VAGINAL||
2439|011|F|(KLIN-da-MYE-sin)||
2439|012|B|||
2439|013|C|COMMON BRAND NAME(S): Xaciato||
2439|014|B|||
2439|015|U|USES:  This medication is used to treat a certain type of vaginal||
2439|016|U|infection (bacterial vaginosis). Clindamycin is an antibiotic||
2439|017|U|that works by stopping the growth of bacteria.||
2439|018|B|||
2439|019|H|HOW TO USE:  Read the Patient Information Leaflet and the||
2439|020|H|Instructions for Use if available from your pharmacist before you||
2439|021|H|start using clindamycin. If you have any questions, ask your||
2439|022|H|doctor or pharmacist.||
2439|023|H|   This product is for vaginal use only. Wash your hands before||
2439|024|H|and after use. Avoid contact of this medication with your eyes,||
2439|025|H|mouth, or skin.||
2439|026|H|   Insert 1 applicatorful of this medication into your vagina as||
2439|027|H|directed by your doctor. This product is used as a single||
2439|028|H|(one-time) dose.||
2439|029|H|   After filling the applicator as directed, lie on your back||
2439|030|H|with your legs slightly bent. Gently insert the applicator filled||
2439|031|H|with medication into the vagina as far as it will comfortably go.||
2439|032|H|Slowly press the plunger to release all the medication into your||
2439|033|H|vagina. Remove the empty applicator from your vagina and throw it||
2439|034|H|away in your household trash. Do not save any medicine that may||
2439|035|H|be left in the tube or applicator for future use.||
2439|036|H|   Do not have vaginal intercourse or use products that go inside||
2439|037|H|your vagina (such as tampons or douches) while using this||
2439|038|H|medication and for 3 days after using it. These products may make||
2439|039|H|this medication work less well. Unscented sanitary pads may be||
2439|040|H|used to protect your clothing from leakage of the medication.||
2439|041|H|   This medication may weaken polyurethane condoms. Do not use||
2439|042|H|polyurethane condoms while using this medication and for 7 days||
2439|043|H|after treatment, since they may not work properly to prevent||
2439|044|H|pregnancy or protect against sexually transmitted diseases. Latex||
2439|045|H|or polyisoprene condoms may be used instead. Ask your pharmacist||
2439|046|H|if you have any questions about the types of condoms you may use.||
2439|047|H|   Tell your doctor if your condition lasts, gets worse, or||
2439|048|H|returns after treatment.||
2439|049|B|||
2439|050|S|SIDE EFFECTS:  Vaginal itching, irritation, or a change in||
2439|051|S|discharge may occur. If any of these effects last or get worse,||
2439|052|S|tell your doctor or pharmacist promptly. These symptoms could||
2439|053|S|also be due to a new vaginal infection (such as a yeast/fungal||
2439|054|S|infection) and require other treatment.||
2439|055|S|   Remember that this medication has been prescribed because your||
2439|056|S|doctor has judged that the benefit to you is greater than the||
2439|057|S|risk of side effects. Many people using this medication do not||
2439|058|S|have serious side effects.||
2439|059|S|   A very small amount of this medication may be absorbed into||
2439|060|S|your blood and may rarely cause a severe intestinal condition due||
2439|061|S|to a bacteria called C. difficile. This condition may occur||
2439|062|S|during treatment or weeks to months after treatment has stopped.||
2439|063|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2439|064|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2439|065|S|stool.||
2439|066|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2439|067|S|products because they may make symptoms worse.||
2439|068|S|   A very serious allergic reaction to this drug is rare.||
2439|069|S|However, get medical help right away if you notice any symptoms||
2439|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2439|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2439|072|S|breathing.||
2439|073|S|   This is not a complete list of possible side effects. If you||
2439|074|S|notice other effects not listed above, contact your doctor or||
2439|075|S|pharmacist.||
2439|076|S|   In the US -||
2439|077|S|   Call your doctor for medical advice about side effects. You||
2439|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2439|079|S|www.fda.gov/medwatch.||
2439|080|S|   In Canada - Call your doctor for medical advice about side||
2439|081|S|effects. You may report side effects to Health Canada at||
2439|082|S|1-866-234-2345.||
2439|083|B|||
2439|084|P|PRECAUTIONS:  Before using clindamycin, tell your doctor or||
2439|085|P|pharmacist if you are allergic to it; or to lincomycin; or if you||
2439|086|P|have any other allergies. This product may contain inactive||
2439|087|P|ingredients, which can cause allergic reactions or other||
2439|088|P|problems. Talk to your pharmacist for more details.||
2439|089|P|   Before using this medication, tell your doctor or pharmacist||
2439|090|P|your medical history, especially of: intestinal disease (such as||
2439|091|P|ulcerative colitis, Crohn's disease).||
2439|092|P|   During pregnancy, this medication should be used only when||
2439|093|P|clearly needed. Antibiotics taken by mouth have been used to||
2439|094|P|treat vaginal infections during pregnancy, especially high-risk||
2439|095|P|pregnancies (such as if there is a risk of early childbirth).||
2439|096|P|Consult your doctor for more details and to discuss the risks and||
2439|097|P|benefits.||
2439|098|P|   It is unknown if this medication passes into breast milk.||
2439|099|P|Consult your doctor before breastfeeding.||
2439|100|B|||
2439|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2439|102|I|medications work or increase your risk for serious side effects.||
2439|103|I|This document does not contain all possible drug interactions.||
2439|104|I|Keep a list of all the products you use (including||
2439|105|I|prescription/nonprescription drugs and herbal products) and share||
2439|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
2439|107|I|the dosage of any medicines without your doctor's approval.||
2439|108|B|||
2439|109|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2439|110|O|has overdosed and has serious symptoms such as passing out or||
2439|111|O|trouble breathing, call 911. Otherwise, call a poison control||
2439|112|O|center right away. US residents can call 1-800-222-1222. Canada||
2439|113|O|residents can call 1-844-764-7669.||
2439|114|B|||
2439|115|N|NOTES:  Do not share this medication with others.||
2439|116|B|||
2439|117|D|MISSED DOSE:  Not applicable.||
2439|118|B|||
2439|119|R|STORAGE:  Store at room temperature. Keep all medications away||
2439|120|R|from children and pets.||
2439|121|R|   Do not flush medications down the toilet or pour them into a||
2439|122|R|drain unless instructed to do so. Properly discard this product||
2439|123|R|when it is expired or no longer needed. Consult your pharmacist||
2439|124|R|or local waste disposal company.||
2439|125|B|||
2439|126|A|Information last revised May 2024.||
2439|127|A|Copyright(c) 2025 First Databank, Inc.||
2439|128|B|||
2440|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2440|002|Z|does NOT have all possible information about this product. This||
2440|003|Z|information does not assure that this product is safe, effective,||
2440|004|Z|or appropriate for you. This information is not individual||
2440|005|Z|medical advice and does not substitute for the advice of your||
2440|006|Z|health care professional. Always ask your health care||
2440|007|Z|professional for complete information about this product and your||
2440|008|Z|specific health needs.||
2440|009|B|||
2440|010|T|OLOPATADINE/MOMETASONE SPRAY - NASAL||
2440|011|F|(OH-loe-PAT-a-deen/moe-MET-a-sone)||
2440|012|B|||
2440|013|C|COMMON BRAND NAME(S): Ryaltris||
2440|014|B|||
2440|015|U|USES:  This product is used to relieve seasonal allergy symptoms||
2440|016|U|of the nose such as stuffy/runny nose, itching, sneezing, and||
2440|017|U|post-nasal drip. It contains 2 drugs. Olopatadine is an||
2440|018|U|antihistamine that works by blocking certain natural substances||
2440|019|U|called histamines that are responsible for allergic symptoms.||
2440|020|U|Mometasone belongs to a class of drugs known as corticosteroids.||
2440|021|U|It works by reducing swelling in the nasal passages.||
2440|022|B|||
2440|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2440|024|H|from your pharmacist before you start using||
2440|025|H|olopatadine/mometasone and each time you get a refill. Follow the||
2440|026|H|illustrated directions for the proper use of this medication. If||
2440|027|H|you have any questions, ask your doctor or pharmacist.||
2440|028|H|   Use this medication in the nose as directed by your doctor,||
2440|029|H|usually twice a day in both nostrils. Do not spray in the eyes or||
2440|030|H|mouth. Gently blow your nose before using this drug. Shake the||
2440|031|H|container well before each use. Follow the instructions for test||
2440|032|H|sprays in the air if you are using the container for the first||
2440|033|H|time or if you have not used it for awhile (for example, more||
2440|034|H|than 2 weeks). Check your product package for instructions on||
2440|035|H|when you need to do the test sprays again if you have not used||
2440|036|H|the container in awhile.||
2440|037|H|   To use the spray, remove the protective cap. Close one nostril||
2440|038|H|by pressing it with your finger. Tilt your head slightly forward||
2440|039|H|and, keeping the bottle upright, carefully insert the nasal||
2440|040|H|applicator into the other nostril. Press down firmly on the pump||
2440|041|H|to deliver the prescribed number of sprays. Do not spray directly||
2440|042|H|onto the middle wall of your nose (nasal septum). Breathe in||
2440|043|H|gently through your nose and out through your mouth. Repeat in||
2440|044|H|the other nostril. Wipe the applicator tip and replace the||
2440|045|H|plastic cap. Avoid blowing your nose for 15 minutes after using||
2440|046|H|this medication.||
2440|047|H|   Use this medication regularly to get the most benefit from it.||
2440|048|H|To help you remember, use it at the same times each day. Do not||
2440|049|H|increase your dose or use it more often than prescribed.||
2440|050|H|   Keep track of the number of sprays used from the container.||
2440|051|H|Discard the container after you have used the number of sprays||
2440|052|H|specified on the manufacturer's package. Follow the package||
2440|053|H|instructions to unblock the spray tip if needed and to clean the||
2440|054|H|spray bottle.||
2440|055|H|   You may feel the product start to work as soon as 15 minutes||
2440|056|H|after the first dose, but it may take several weeks before you||
2440|057|H|get the full benefit of this product. Tell your doctor if you do||
2440|058|H|not get better or if you get worse.||
2440|059|B|||
2440|060|S|SIDE EFFECTS:  A bitter taste in the mouth, nosebleeds, or||
2440|061|S|irritation/soreness in the nose may occur. Drowsiness may rarely||
2440|062|S|occur. If any of these effects last or get worse, tell your||
2440|063|S|doctor or pharmacist promptly.||
2440|064|S|   Remember that this medication has been prescribed because your||
2440|065|S|doctor has judged that the benefit to you is greater than the||
2440|066|S|risk of side effects. Many people using this medication do not||
2440|067|S|have serious side effects.||
2440|068|S|   Tell your doctor right away if you have any serious side||
2440|069|S|effects, including: pain/sores in your nose, white patches in||
2440|070|S|your nose/mouth, painful swallowing/trouble swallowing.||
2440|071|S|   Rarely, it is possible that corticosteroids given in the nose||
2440|072|S|will be absorbed into the bloodstream. This can lead to side||
2440|073|S|effects of too much corticosteroid. These side effects are more||
2440|074|S|likely in children and people who use this medication for a long||
2440|075|S|time and in high doses. Tell your doctor right away if any of the||
2440|076|S|following side effects occur: unusual/extreme tiredness, weight||
2440|077|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
2440|078|S|vision problems.||
2440|079|S|   A very serious allergic reaction to this drug is rare.||
2440|080|S|However, get medical help right away if you notice any symptoms||
2440|081|S|of a serious allergic reaction, including: rash, itching/swelling||
2440|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2440|083|S|breathing.||
2440|084|S|   This is not a complete list of possible side effects. If you||
2440|085|S|notice other effects not listed above, contact your doctor or||
2440|086|S|pharmacist.||
2440|087|S|   In the US -||
2440|088|S|   Call your doctor for medical advice about side effects. You||
2440|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2440|090|S|www.fda.gov/medwatch.||
2440|091|S|   In Canada - Call your doctor for medical advice about side||
2440|092|S|effects. You may report side effects to Health Canada at||
2440|093|S|1-866-234-2345.||
2440|094|B|||
2440|095|P|PRECAUTIONS:  Before using olopatadine/mometasone, tell your||
2440|096|P|doctor or pharmacist if you are allergic to olopatadine or||
2440|097|P|mometasone; or if you have any other allergies. This product may||
2440|098|P|contain inactive ingredients, which can cause allergic reactions||
2440|099|P|or other problems. Talk to your pharmacist for more details.||
2440|100|P|   Before using this medication, tell your doctor or pharmacist||
2440|101|P|your medical history, especially of: eye problems (such as||
2440|102|P|glaucoma, cataracts), infections (including tuberculosis, herpes||
2440|103|P|eye infection), recent nose problems (such as injury, ulcers,||
2440|104|P|surgery).||
2440|105|P|   This medication may rarely make you drowsy. Alcohol or||
2440|106|P|marijuana (cannabis) can make you more drowsy. Do not drive, use||
2440|107|P|machinery, or do anything that needs alertness until you can do||
2440|108|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2440|109|P|are using marijuana (cannabis).||
2440|110|P|   Stay away from anyone who has an infection that may easily||
2440|111|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2440|112|P|doctor if you have been exposed to an infection or for more||
2440|113|P|details.||
2440|114|P|   Rarely, using corticosteroid medications for a long time can||
2440|115|P|make it more difficult for your body to respond to physical||
2440|116|P|stress. Before having surgery or emergency treatment, or if you||
2440|117|P|get a serious illness/injury, tell your doctor or dentist that||
2440|118|P|you are using this medication or have used this medication within||
2440|119|P|the past few months.||
2440|120|P|   Though it is unlikely, this medication may temporarily slow||
2440|121|P|down a child's growth if used for a long time. See the doctor||
2440|122|P|regularly so your child's height can be checked.||
2440|123|P|   During pregnancy, this medication should be used only when||
2440|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
2440|125|P|   It is unknown if this medication passes into breast milk.||
2440|126|P|Consult your doctor before breastfeeding.||
2440|127|B|||
2440|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2440|129|I|medications work or increase your risk for serious side effects.||
2440|130|I|This document does not contain all possible drug interactions.||
2440|131|I|Keep a list of all the products you use (including||
2440|132|I|prescription/nonprescription drugs and herbal products) and share||
2440|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
2440|134|I|the dosage of any medicines without your doctor's approval.||
2440|135|I|   Tell your doctor or pharmacist if you are taking other||
2440|136|I|products that cause drowsiness such as opioid pain or cough||
2440|137|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2440|138|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2440|139|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2440|140|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
2440|141|I|diphenhydramine).||
2440|142|I|   Check the labels on all your medicines (such as allergy or||
2440|143|I|cough-and-cold products) because they may contain ingredients||
2440|144|I|that cause drowsiness. Ask your pharmacist about using those||
2440|145|I|products safely.||
2440|146|B|||
2440|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2440|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2440|149|O|poison control center right away. US residents can call||
2440|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2440|151|B|||
2440|152|N|NOTES:  Do not share this medication with others.||
2440|153|N|   If you use this medication for a long time, lab and/or medical||
2440|154|N|tests (such as nose exams, height measurement in children) may be||
2440|155|N|done while you are using this medication. Keep all medical and||
2440|156|N|lab appointments.||
2440|157|N|   Avoid substances that can worsen breathing problems by causing||
2440|158|N|irritation or allergic reaction, such as smoke, pollen, pet||
2440|159|N|dander, dust, and mold.||
2440|160|B|||
2440|161|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2440|162|D|If it is near the time of the next dose, skip the missed dose.||
2440|163|D|Use your next dose at the regular time. Do not double the dose to||
2440|164|D|catch up.||
2440|165|B|||
2440|166|R|STORAGE:  Store upright at room temperature. Do not freeze or||
2440|167|R|refrigerate. Keep all medications away from children and pets.||
2440|168|R|   Do not flush medications down the toilet or pour them into a||
2440|169|R|drain unless instructed to do so. Properly discard this product||
2440|170|R|when it is expired or no longer needed. Consult your pharmacist||
2440|171|R|or local waste disposal company.||
2440|172|B|||
2440|173|A|Information last revised September 2024.||
2440|174|A|Copyright(c) 2025 First Databank, Inc.||
2440|175|B|||
2441|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2441|002|Z|does NOT have all possible information about this product. This||
2441|003|Z|information does not assure that this product is safe, effective,||
2441|004|Z|or appropriate for you. This information is not individual||
2441|005|Z|medical advice and does not substitute for the advice of your||
2441|006|Z|health care professional. Always ask your health care||
2441|007|Z|professional for complete information about this product and your||
2441|008|Z|specific health needs.||
2441|009|B|||
2441|010|T|BETIBEGLOGENE AUTOTEMCEL - INJECTION||
2441|011|F|(BE-ti-BEG-lo-jeen AW-to-TEM-sel)||
2441|012|B|||
2441|013|C|COMMON BRAND NAME(S): Zynteglo||
2441|014|B|||
2441|015|U|USES:  Betibeglogene autotemcel is used to treat a certain||
2441|016|U|inherited blood disorder (beta thalassemia). In this condition,||
2441|017|U|your body does not make enough of a certain protein (hemoglobin)||
2441|018|U|that is needed to carry oxygen to many parts of your body. This||
2441|019|U|type of treatment is known as gene therapy. Your betibeglogene||
2441|020|U|autotemcel is made from your own blood stem cells and is given||
2441|021|U|only to you. The blood stem cells have been changed to have genes||
2441|022|U|that work properly so that you can make increased amounts of||
2441|023|U|hemoglobin. This may allow you to make enough hemoglobin to stop||
2441|024|U|receiving regular blood transfusions.||
2441|025|B|||
2441|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2441|027|H|from your pharmacist before you receive this product. If you have||
2441|028|H|any questions, ask your doctor or pharmacist.||
2441|029|H|   Your doctor will give you other medications (such as||
2441|030|H|chemotherapy) before treatment with this product to prepare your||
2441|031|H|body.||
2441|032|H|   This product is given by slow injection into a vein as||
2441|033|H|directed by your doctor. To decrease the risk of side effects,||
2441|034|H|your doctor may also give you other medications before injecting||
2441|035|H|betibeglogene autotemcel. The dosage is based on your medical||
2441|036|H|condition and weight.||
2441|037|H|   After you receive this product, you will stay in the hospital||
2441|038|H|for about 3 to 6 weeks so your doctor can check to see if your||
2441|039|H|treatment is working and help you manage any side effects.||
2441|040|B|||
2441|041|S|SIDE EFFECTS:  Pain in the abdomen, arms, or legs may occur. If||
2441|042|S|this effect lasts or gets worse, tell your doctor or pharmacist||
2441|043|S|promptly.||
2441|044|S|   Remember that this medication has been prescribed because your||
2441|045|S|doctor has judged that the benefit to you is greater than the||
2441|046|S|risk of side effects. Many people using this medication do not||
2441|047|S|have serious side effects.||
2441|048|S|   Treatment with this product may lead to a low number of blood||
2441|049|S|cells such as red cells, white cells, and platelets. This effect||
2441|050|S|can cause anemia, decrease your body's ability to fight an||
2441|051|S|infection, or cause easy bruising/bleeding. Tell your doctor||
2441|052|S|right away if you develop any of the following symptoms: unusual||
2441|053|S|tiredness, pale skin, signs of infection (such as sore throat||
2441|054|S|that doesn't go away, fever, chills), easy bruising/bleeding.||
2441|055|S|   This product may rarely increase your risk of developing blood||
2441|056|S|cancer. Your doctor should do regular blood tests for at least 15||
2441|057|S|years to monitor for any changes to your blood.||
2441|058|S|   A very serious allergic reaction to this drug is rare.||
2441|059|S|However, get medical help right away if you notice any symptoms||
2441|060|S|of a serious allergic reaction, including: rash, itching/swelling||
2441|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2441|062|S|breathing.||
2441|063|S|   This is not a complete list of possible side effects. If you||
2441|064|S|notice other effects not listed above, contact your doctor or||
2441|065|S|pharmacist.||
2441|066|S|   In the US -||
2441|067|S|   Call your doctor for medical advice about side effects. You||
2441|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2441|069|S|www.fda.gov/medwatch.||
2441|070|S|   In Canada - Call your doctor for medical advice about side||
2441|071|S|effects. You may report side effects to Health Canada at||
2441|072|S|1-866-234-2345.||
2441|073|B|||
2441|074|P|PRECAUTIONS:  Before receiving betibeglogene autotemcel, tell||
2441|075|P|your doctor or pharmacist if you have any allergies. This product||
2441|076|P|may contain inactive ingredients, which can cause allergic||
2441|077|P|reactions or other problems. Talk to your pharmacist for more||
2441|078|P|details.||
2441|079|P|   Before using this medication, tell your doctor or pharmacist||
2441|080|P|your medical history, especially of: past/current/recent||
2441|081|P|infection (including hepatitis, HIV), kidney problems, liver||
2441|082|P|problems.||
2441|083|P|   This product can make you more likely to get infections or may||
2441|084|P|make current infections worse. Stay away from anyone who has an||
2441|085|P|infection that may easily spread (such as chickenpox, COVID-19,||
2441|086|P|measles, flu). Talk to your doctor if you have been exposed to an||
2441|087|P|infection or for more details.||
2441|088|P|   Tell your health care professional that you have received this||
2441|089|P|product before having any immunizations/vaccinations. Avoid||
2441|090|P|contact with people who have recently received live vaccines||
2441|091|P|(such as flu vaccine inhaled through the nose).||
2441|092|P|   To lower the chance of getting cut, bruised, or injured, use||
2441|093|P|caution with sharp objects like razors and nail cutters, and||
2441|094|P|avoid activities such as contact sports.||
2441|095|P|   Before having surgery, tell your doctor or dentist about all||
2441|096|P|the products you use (including prescription drugs,||
2441|097|P|nonprescription drugs, and herbal products).||
2441|098|P|   Tell your doctor if you are pregnant or plan to become||
2441|099|P|pregnant. You should not become pregnant while using||
2441|100|P|betibeglogene autotemcel. This medication may harm an unborn||
2441|101|P|baby. Your doctor should order a pregnancy test before you start||
2441|102|P|this medication. Men and women using this medication should ask||
2441|103|P|about reliable forms of birth control during treatment and for at||
2441|104|P|least 6 months after the last dose. If you or your partner||
2441|105|P|becomes pregnant, talk to your doctor right away about the risks||
2441|106|P|and benefits of this medication.||
2441|107|P|   It is unknown if this medication passes into breast milk.||
2441|108|P|Breastfeeding is not recommended while using this medication.||
2441|109|P|Consult your doctor before breastfeeding.||
2441|110|B|||
2441|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2441|112|I|medications work or increase your risk for serious side effects.||
2441|113|I|This document does not contain all possible drug interactions.||
2441|114|I|Keep a list of all the products you use (including||
2441|115|I|prescription/nonprescription drugs and herbal products) and share||
2441|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
2441|117|I|the dosage of any medicines without your doctor's approval.||
2441|118|I|   Certain medications (such as anti-retroviral drugs,||
2441|119|I|hydroxyurea) may interfere with how this product is made. If you||
2441|120|I|are using any of these, your doctor may have you stop taking them||
2441|121|I|for at least 1 month before the procedure to collect your blood||
2441|122|I|stem cells.||
2441|123|I|   This medication may interfere with certain lab tests (such as||
2441|124|I|some HIV tests), possibly causing false test results. Make sure||
2441|125|I|lab personnel and all your doctors know you use this drug.||
2441|126|B|||
2441|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2441|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2441|129|O|poison control center right away. US residents can call||
2441|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2441|131|B|||
2441|132|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
2441|133|N|should be done before and after you receive this product. Keep||
2441|134|N|all medical and lab appointments.||
2441|135|N|   After receiving this treatment, do not donate blood, organs,||
2441|136|N|tissues, or cells.||
2441|137|B|||
2441|138|D|MISSED DOSE:  Not applicable.||
2441|139|B|||
2441|140|R|STORAGE:  Not applicable. This product is given in a hospital or||
2441|141|R|clinic and will not be stored at home.||
2441|142|B|||
2441|143|M|MEDICAL ALERT:  Your condition can cause complications in a||
2441|144|M|medical emergency. For information about enrolling in MedicAlert,||
2441|145|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2441|146|B|||
2441|147|A|Information last revised May 2024.||
2441|148|A|Copyright(c) 2025 First Databank, Inc.||
2441|149|B|||
2442|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2442|002|Z|does NOT have all possible information about this product. This||
2442|003|Z|information does not assure that this product is safe, effective,||
2442|004|Z|or appropriate for you. This information is not individual||
2442|005|Z|medical advice and does not substitute for the advice of your||
2442|006|Z|health care professional. Always ask your health care||
2442|007|Z|professional for complete information about this product and your||
2442|008|Z|specific health needs.||
2442|009|B|||
2442|010|T|BETAMETHASONE - INJECTION||
2442|011|F|(BAY-ta-METH-a-sone)||
2442|012|B|||
2442|013|C|COMMON BRAND NAME(S): Celestone||
2442|014|B|||
2442|015|U|USES:  This medication is used in a variety of conditions such as||
2442|016|U|allergic disorders, arthritis, gout, blood diseases, breathing||
2442|017|U|problems, certain cancers, eye diseases, intestinal disorders,||
2442|018|U|and collagen and skin diseases. Talk to your doctor about the||
2442|019|U|risks and benefits of betamethasone, especially if it is to be||
2442|020|U|injected near your spine (epidural). Rare but serious side||
2442|021|U|effects may occur with epidural use.||
2442|022|U|   Betamethasone is known as a corticosteroid hormone||
2442|023|U|(glucocorticoid). It works by decreasing your body's immune||
2442|024|U|response to these diseases and reduces symptoms such as swelling.||
2442|025|B|||
2442|026|H|HOW TO USE:  Depending on your product, this medication is given||
2442|027|H|by injection into areas such as a muscle, a skin lesion, or a||
2442|028|H|joint. Injections are usually given by a health care||
2442|029|H|professional.||
2442|030|H|   If you are using this medication at home, learn all||
2442|031|H|preparation and usage instructions from your health care||
2442|032|H|professional. Before using, check this product for clumps or||
2442|033|H|discoloration. If either is present, do not use the liquid. Shake||
2442|034|H|the vial before use. Before injecting each dose, clean the||
2442|035|H|injection site with rubbing alcohol. If injecting into a muscle,||
2442|036|H|change the injection site each time to lessen injury under the||
2442|037|H|skin. Learn how to store and discard medical supplies safely.||
2442|038|H|   Use this medication exactly as directed by your doctor. Do not||
2442|039|H|change your dose or use this medication for a longer time than||
2442|040|H|prescribed. The injection site, schedule, dosage, and length of||
2442|041|H|treatment are based on your medical condition and response to||
2442|042|H|treatment. Do not inject this medication into a vein or into the||
2442|043|H|area around the spinal cord (epidural). This medication is not||
2442|044|H|recommended for injection around/into the eye or certain parts of||
2442|045|H|the nose due to the risk for blindness or damage to the eye(s).||
2442|046|H|Consult your doctor for more details.||
2442|047|H|   If you have been using this medication for a long time, do not||
2442|048|H|suddenly stop it without your doctor's approval. Some conditions||
2442|049|H|may become worse when this drug is suddenly stopped. Your dose||
2442|050|H|may need to be gradually decreased to reduce symptoms such as||
2442|051|H|weakness, weight loss, nausea, and extreme tiredness.||
2442|052|H|   If you have received an injection into a joint, be careful how||
2442|053|H|much stress you put on that joint, even if it is feeling better.||
2442|054|H|Ask your doctor how much you can move the joint while it is||
2442|055|H|healing.||
2442|056|H|   Tell your doctor if your condition gets worse or if you have||
2442|057|H|new symptoms.||
2442|058|B|||
2442|059|S|SIDE EFFECTS:  Redness or pain at the injection site, stomach||
2442|060|S|upset, headache, dizziness, trouble sleeping, or weight gain may||
2442|061|S|occur. If any of these effects last or get worse, tell your||
2442|062|S|doctor or pharmacist promptly.||
2442|063|S|   Remember that this medication has been prescribed because your||
2442|064|S|doctor has judged that the benefit to you is greater than the||
2442|065|S|risk of side effects. Many people using this medication do not||
2442|066|S|have serious side effects.||
2442|067|S|   This medication may raise your blood pressure. Check your||
2442|068|S|blood pressure regularly and tell your doctor if the results are||
2442|069|S|high.||
2442|070|S|   This medication may make your blood sugar rise, which can||
2442|071|S|cause or worsen diabetes. Tell your doctor right away if you have||
2442|072|S|symptoms of high blood sugar such as increased thirst/urination.||
2442|073|S|If you already have diabetes, check your blood sugar regularly as||
2442|074|S|directed and share the results with your doctor. Your doctor may||
2442|075|S|need to adjust your diabetes medication, exercise program, or||
2442|076|S|diet.||
2442|077|S|   This medication may lower your ability to fight infections.||
2442|078|S|This may make you more likely to get a serious (rarely fatal)||
2442|079|S|infection or make any infection you have worse. Tell your doctor||
2442|080|S|right away if you have any signs of infection (such as sore||
2442|081|S|throat that doesn't go away, fever, chills).||
2442|082|S|   Tell your doctor right away if you have any serious side||
2442|083|S|effects, including: weakness, puffy face, unusual weight gain,||
2442|084|S|thinning skin, bone pain, menstrual period changes, mental/mood||
2442|085|S|changes (such as depression, mood swings, agitation), easy||
2442|086|S|bruising/bleeding, vision problems, swelling ankles/feet/hands,||
2442|087|S|fast/slow/irregular heartbeat, red/purple spots on the skin.||
2442|088|S|   If you have received an injection of this medication into the||
2442|089|S|joint, temporary discomfort of the joint may occur. Tell your||
2442|090|S|doctor right away if you have fever, increased/severe pain with||
2442|091|S|swelling of the joint, weakness in the joint, or decreased range||
2442|092|S|of motion in the joint.||
2442|093|S|   Get medical help right away if you have any very serious side||
2442|094|S|effects, including: symptoms of stomach/intestinal bleeding (such||
2442|095|S|as stomach/abdominal pain, black/tarry stools, vomit that looks||
2442|096|S|like coffee grounds).||
2442|097|S|   A very serious allergic reaction to this drug is rare.||
2442|098|S|However, get medical help right away if you notice any symptoms||
2442|099|S|of a serious allergic reaction, including: rash, itching/swelling||
2442|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2442|101|S|breathing.||
2442|102|S|   This is not a complete list of possible side effects. If you||
2442|103|S|notice other effects not listed above, contact your doctor or||
2442|104|S|pharmacist.||
2442|105|S|   In the US -||
2442|106|S|   Call your doctor for medical advice about side effects. You||
2442|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2442|108|S|www.fda.gov/medwatch.||
2442|109|S|   In Canada - Call your doctor for medical advice about side||
2442|110|S|effects. You may report side effects to Health Canada at||
2442|111|S|1-866-234-2345.||
2442|112|B|||
2442|113|P|PRECAUTIONS:  Before using betamethasone, tell your doctor or||
2442|114|P|pharmacist if you are allergic to it; or to other corticosteroids||
2442|115|P|(such as methylprednisolone); or if you have any other allergies.||
2442|116|P|This product may contain inactive ingredients, which can cause||
2442|117|P|allergic reactions or other problems. Talk to your pharmacist for||
2442|118|P|more details.||
2442|119|P|   Before using this medication, tell your doctor or pharmacist||
2442|120|P|your medical history, especially of: bleeding problems, blood||
2442|121|P|clots, bone loss (osteoporosis), diabetes, certain eye diseases||
2442|122|P|(such as cataracts, glaucoma, herpes infection of the eye), heart||
2442|123|P|problems (such as heart failure, recent heart attack), high blood||
2442|124|P|pressure, current/past infections (such as joint infections and||
2442|125|P|infections caused by fungus, herpes, tuberculosis, threadworm),||
2442|126|P|kidney disease, liver disease (such as hepatitis B), mental/mood||
2442|127|P|conditions (such as psychosis, anxiety, depression),||
2442|128|P|stomach/intestinal problems (such as diverticulitis, ulcer,||
2442|129|P|ulcerative colitis), seizures, thyroid problems, mineral||
2442|130|P|imbalance, a certain adrenal gland tumor (pheochromocytoma).||
2442|131|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2442|132|P|can make you more dizzy. Do not drive, use machinery, or do||
2442|133|P|anything that needs alertness until you can do it safely. Limit||
2442|134|P|alcoholic beverages. Talk to your doctor if you are using||
2442|135|P|marijuana (cannabis).||
2442|136|P|   Using corticosteroid medications for a long time can make it||
2442|137|P|more difficult for your body to respond to physical stress.||
2442|138|P|Before having surgery or emergency treatment, or if you get a||
2442|139|P|serious illness/injury, tell your doctor or dentist that you are||
2442|140|P|using this medication or have used this medication within the||
2442|141|P|past 12 months. Tell your doctor right away if you develop||
2442|142|P|unusual/extreme tiredness or weight loss. If you will be using||
2442|143|P|this medication for a long time, carry a warning card or medical||
2442|144|P|ID bracelet that identifies your use of this medication.||
2442|145|P|   This medication may mask signs of infection. It can make you||
2442|146|P|more likely to get infections or may make current infections||
2442|147|P|worse. Stay away from anyone who has an infection that may easily||
2442|148|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2442|149|P|doctor if you have been exposed to an infection or for more||
2442|150|P|details.||
2442|151|P|   Tell your health care professional that you are using||
2442|152|P|betamethasone before having any immunizations, vaccinations, or||
2442|153|P|skin tests. Avoid contact with people who have recently received||
2442|154|P|live vaccines (such as flu vaccine inhaled through the nose).||
2442|155|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
2442|156|P|while using this medicine may increase your risk for stomach||
2442|157|P|bleeding. Limit alcoholic beverages.||
2442|158|P|   Older adults may be more sensitive to the side effects of this||
2442|159|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
2442|160|P|mental/mood changes (such as confusion).||
2442|161|P|   This medication may slow down a child's growth if used for a||
2442|162|P|long time. Consult the doctor or pharmacist for more details. See||
2442|163|P|the doctor regularly so your child's height and growth can be||
2442|164|P|checked.||
2442|165|P|   During pregnancy, this medication should be used only when||
2442|166|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
2442|167|P|risks and benefits with your doctor. Infants born to mothers who||
2442|168|P|use corticosteroid medications for a long time may have hormone||
2442|169|P|problems. Tell your doctor right away if you notice symptoms such||
2442|170|P|as nausea/vomiting that doesn't stop, severe diarrhea, or||
2442|171|P|weakness in your newborn.||
2442|172|P|   It is unknown if this medication passes into breast milk.||
2442|173|P|Consult your doctor before breastfeeding.||
2442|174|B|||
2442|175|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2442|176|I|medications work or increase your risk for serious side effects.||
2442|177|I|This document does not contain all possible drug interactions.||
2442|178|I|Keep a list of all the products you use (including||
2442|179|I|prescription/nonprescription drugs and herbal products) and share||
2442|180|I|it with your doctor and pharmacist. Do not start, stop, or change||
2442|181|I|the dosage of any medicines without your doctor's approval.||
2442|182|I|   Some products that may interact with this drug are:||
2442|183|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
2442|184|I|cause bleeding/bruising (including antiplatelet drugs such as||
2442|185|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
2442|186|I|such as warfarin/dabigatran).||
2442|187|I|   Aspirin can increase the risk of bleeding when used with this||
2442|188|I|medication. However, if your doctor has told you to take low-dose||
2442|189|I|aspirin to prevent heart attack or stroke (usually 81-162||
2442|190|I|milligrams a day), you should keep taking the aspirin unless your||
2442|191|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2442|192|I|details.||
2442|193|I|   This medication may interfere with certain lab tests (such as||
2442|194|I|skin tests), possibly causing false test results. Make sure lab||
2442|195|I|personnel and all your doctors know you use this drug.||
2442|196|B|||
2442|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2442|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2442|199|O|poison control center right away. US residents can call||
2442|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2442|201|B|||
2442|202|N|NOTES:  Do not share this medication with others.||
2442|203|N|   Lab and/or medical tests (such as blood counts, blood||
2442|204|N|glucose/mineral levels, blood pressure, bone density tests,||
2442|205|N|height/weight measurements, eye exams, x-rays) should be done||
2442|206|N|while you are using this medication. Keep all medical and lab||
2442|207|N|appointments. Consult your doctor for more details.||
2442|208|N|   This medication may cause bone loss (osteoporosis) when used||
2442|209|N|for a long time. Lifestyle changes that may help reduce the risk||
2442|210|N|of bone problems include doing weight-bearing exercise, stopping||
2442|211|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2442|212|N|D. Talk to your doctor for more details.||
2442|213|N|   If you use this medication for longer periods, you should wear||
2442|214|N|or carry identification stating that you are using it.||
2442|215|B|||
2442|216|D|MISSED DOSE:  It is important to get each dose of this medication||
2442|217|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2442|218|D|right away for a new dosing schedule. Do not double the dose to||
2442|219|D|catch up.||
2442|220|B|||
2442|221|R|STORAGE:  Store at room temperature away from light. Do not||
2442|222|R|freeze. Keep all medications away from children and pets.||
2442|223|R|   Do not flush medications down the toilet or pour them into a||
2442|224|R|drain unless instructed to do so. Properly discard this product||
2442|225|R|when it is expired or no longer needed. Consult your pharmacist||
2442|226|R|or local waste disposal company.||
2442|227|B|||
2442|228|A|Information last revised September 2025.||
2442|229|A|Copyright(c) 2025 First Databank, Inc.||
2442|230|B|||
2443|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2443|002|Z|does NOT have all possible information about this product. This||
2443|003|Z|information does not assure that this product is safe, effective,||
2443|004|Z|or appropriate for you. This information is not individual||
2443|005|Z|medical advice and does not substitute for the advice of your||
2443|006|Z|health care professional. Always ask your health care||
2443|007|Z|professional for complete information about this product and your||
2443|008|Z|specific health needs.||
2443|009|B|||
2443|010|T|IBRUTINIB SUSPENSION - ORAL||
2443|011|F|(eye-BROO-ti-nib)||
2443|012|B|||
2443|013|C|COMMON BRAND NAME(S): Imbruvica||
2443|014|B|||
2443|015|U|USES:  This medication is used to treat certain cancers (such as||
2443|016|U|chronic lymphocytic leukemia/small lymphocytic lymphoma,||
2443|017|U|Waldenstrom's macroglobulinemia). Ibrutinib belongs to a class of||
2443|018|U|drugs known as kinase inhibitors. It works by slowing or stopping||
2443|019|U|the growth of cancer cells.||
2443|020|U|   Ibrutinib is also used to treat a certain problem that may||
2443|021|U|occur after a stem cell transplant (chronic graft versus host||
2443|022|U|disease). It works by weakening your body's defense system||
2443|023|U|(immune system).||
2443|024|B|||
2443|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
2443|026|H|Instructions for Use if available from your pharmacist before you||
2443|027|H|start taking ibrutinib and each time you get a refill. If you||
2443|028|H|have any questions, ask your doctor or pharmacist.||
2443|029|H|   Take this medication by mouth as directed by your doctor,||
2443|030|H|usually once daily. Use this medication regularly to get the most||
2443|031|H|benefit from it. To help you remember, take it at the same time||
2443|032|H|each day.||
2443|033|H|   Shake the bottle well before each dose. Carefully measure the||
2443|034|H|dose using a special measuring device/spoon. Do not use a||
2443|035|H|household spoon because you may not get the correct dose.||
2443|036|H|   The dosage is based on your medical condition, response to||
2443|037|H|treatment, and other medications you may be taking. Children's||
2443|038|H|dosage is also based on age and body size. Be sure to tell your||
2443|039|H|doctor and pharmacist about all the products you use (including||
2443|040|H|prescription drugs, nonprescription drugs, and herbal products).||
2443|041|H|   Do not increase your dose or take this medication more often||
2443|042|H|than prescribed. Your condition will not improve any faster, and||
2443|043|H|your risk of serious side effects will increase.||
2443|044|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2443|045|H|using this medication unless your doctor or pharmacist says you||
2443|046|H|may do so safely. Also avoid eating Seville oranges (often found||
2443|047|H|in marmalade). Grapefruit and Seville oranges can increase the||
2443|048|H|chance of side effects with this medicine. Ask your doctor or||
2443|049|H|pharmacist for more details.||
2443|050|H|   Since this drug can be absorbed through the skin and lungs and||
2443|051|H|may harm an unborn baby, women who are pregnant or who may become||
2443|052|H|pregnant should not handle this medication.||
2443|053|B|||
2443|054|S|SIDE EFFECTS:  Upset stomach, diarrhea, nausea, vomiting,||
2443|055|S|decreased appetite, headache, joint/muscle pain,||
2443|056|S|numbness/tingling of arms/legs, constipation, dizziness, or||
2443|057|S|tiredness may occur. If any of these effects last or get worse,||
2443|058|S|tell your doctor or pharmacist promptly.||
2443|059|S|   Remember that this medication has been prescribed because your||
2443|060|S|doctor has judged that the benefit to you is greater than the||
2443|061|S|risk of side effects. Many people using this medication do not||
2443|062|S|have serious side effects.||
2443|063|S|   This medication may raise your blood pressure. Check your||
2443|064|S|blood pressure regularly and tell your doctor if the results are||
2443|065|S|high. Your doctor may control your blood pressure with||
2443|066|S|medication.||
2443|067|S|   Tell your doctor right away if you have any serious side||
2443|068|S|effects, including: easy bruising/bleeding, black/bloody stools,||
2443|069|S|vomit that looks like coffee grounds, fast/irregular/pounding||
2443|070|S|heartbeat, unusual tiredness, swelling ankles/feet, signs of low||
2443|071|S|red blood cell count (such as rapid breathing, pale skin,||
2443|072|S|shortness of breath).||
2443|073|S|   Ibrutinib sometimes causes side effects due to the rapid||
2443|074|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
2443|075|S|risk, your doctor may add a medication and tell you to drink||
2443|076|S|plenty of fluids. Tell your doctor right away if you have||
2443|077|S|symptoms such as: low back/side pain (flank pain), signs of||
2443|078|S|kidney problems (such as painful urination, pink/bloody urine,||
2443|079|S|change in the amount of urine), muscle spasms/weakness.||
2443|080|S|   This medication may lower your ability to fight infections.||
2443|081|S|This may make you more likely to get a serious (rarely fatal)||
2443|082|S|infection or make any infection you have worse. Tell your doctor||
2443|083|S|right away if you have any signs of infection (such as sore||
2443|084|S|throat that doesn't go away, fever, chills).||
2443|085|S|   This medication has rarely caused very serious (possibly||
2443|086|S|fatal) liver disease. Tell your doctor right away if you develop||
2443|087|S|symptoms of liver disease, such as nausea/vomiting that doesn't||
2443|088|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
2443|089|S|eyes/skin, dark urine.||
2443|090|S|   Very rarely, people taking this medication have developed||
2443|091|S|other cancers (including skin cancer). Consult your doctor for||
2443|092|S|more details.||
2443|093|S|   Get medical help right away if you have any very serious side||
2443|094|S|effects, including: chest pain, signs of bleeding in the brain or||
2443|095|S|a stroke (such as fainting, sudden vision changes, severe nausea,||
2443|096|S|seizures, confusion, weakness on one side of the body, trouble||
2443|097|S|speaking).||
2443|098|S|   A very serious allergic reaction to this drug is rare.||
2443|099|S|However, get medical help right away if you notice any symptoms||
2443|100|S|of a serious allergic reaction, including: rash, itching/swelling||
2443|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2443|102|S|breathing.||
2443|103|S|   This is not a complete list of possible side effects. If you||
2443|104|S|notice any other effects not listed above, contact your doctor or||
2443|105|S|pharmacist.||
2443|106|S|   In the US -||
2443|107|S|   Call your doctor for medical advice about side effects. You||
2443|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2443|109|S|www.fda.gov/medwatch.||
2443|110|S|   In Canada - Call your doctor for medical advice about side||
2443|111|S|effects. You may report side effects to Health Canada at||
2443|112|S|1-866-234-2345.||
2443|113|B|||
2443|114|P|PRECAUTIONS:  Before taking ibrutinib, tell your doctor or||
2443|115|P|pharmacist if you are allergic to it; or if you have any other||
2443|116|P|allergies. This product may contain inactive ingredients, which||
2443|117|P|can cause allergic reactions or other problems. Talk to your||
2443|118|P|pharmacist for more details.||
2443|119|P|   Before using this medication, tell your doctor or pharmacist||
2443|120|P|your medical history, especially of: blood/bleeding problems,||
2443|121|P|heart problems (such as fast/irregular heartbeat, previous heart||
2443|122|P|attack), high blood pressure, kidney problems, liver problems,||
2443|123|P|high levels of uric acid in the blood.||
2443|124|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2443|125|P|can make you more dizzy. Do not drive, use machinery, or do||
2443|126|P|anything that needs alertness until you can do it safely. Limit||
2443|127|P|alcoholic beverages. Talk to your doctor if you are using||
2443|128|P|marijuana (cannabis).||
2443|129|P|   Ibrutinib can make you more likely to get infections or may||
2443|130|P|make current infections worse. Stay away from anyone who has an||
2443|131|P|infection that may easily spread (such as chickenpox, COVID-19,||
2443|132|P|measles, flu). Talk to your doctor if you have been exposed to an||
2443|133|P|infection or for more details.||
2443|134|P|   Tell your health care professional that you are using||
2443|135|P|ibrutinib before having any immunizations/vaccinations. Avoid||
2443|136|P|contact with people who have recently received live vaccines||
2443|137|P|(such as flu vaccine inhaled through the nose).||
2443|138|P|   To lower the chance of getting cut, bruised, or injured, use||
2443|139|P|caution with sharp objects like razors and nail cutters, and||
2443|140|P|avoid activities such as contact sports.||
2443|141|P|   Before having surgery, tell your doctor or dentist about all||
2443|142|P|the products you use (including prescription drugs,||
2443|143|P|nonprescription drugs, and herbal products). Your doctor may tell||
2443|144|P|you to temporarily stop treatment with this medication before||
2443|145|P|certain medical, surgical, or dental procedures.||
2443|146|P|   Older adults may be at greater risk for low red blood cell||
2443|147|P|count, bleeding, fast/irregular heartbeat, and high blood||
2443|148|P|pressure while using this drug.||
2443|149|P|   Since this drug can be absorbed through the skin and lungs and||
2443|150|P|may harm an unborn baby, women who are pregnant or who may become||
2443|151|P|pregnant should not handle this medication.||
2443|152|P|   Tell your doctor if you are pregnant or plan to become||
2443|153|P|pregnant. You should not become pregnant while using ibrutinib.||
2443|154|P|Ibrutinib may harm an unborn baby. Your doctor should order a||
2443|155|P|pregnancy test before you start this medication. Men and women||
2443|156|P|using this medication should ask about reliable forms of birth||
2443|157|P|control during treatment and for 1 month after the last dose. If||
2443|158|P|you or your partner becomes pregnant, talk to your doctor right||
2443|159|P|away about the risks and benefits of this medication.||
2443|160|P|   It is unknown if this drug passes into breast milk. Because of||
2443|161|P|the possible risk to the infant, breastfeeding is not recommended||
2443|162|P|while using this drug and for 1 week after the last dose. Consult||
2443|163|P|your doctor before breastfeeding.||
2443|164|B|||
2443|165|I|DRUG INTERACTIONS:  See also How to Use section.||
2443|166|I|   Drug interactions may change how your medications work or||
2443|167|I|increase your risk for serious side effects. This document does||
2443|168|I|not contain all possible drug interactions. Keep a list of all||
2443|169|I|the products you use (including prescription/nonprescription||
2443|170|I|drugs and herbal products) and share it with your doctor and||
2443|171|I|pharmacist. Do not start, stop, or change the dosage of any||
2443|172|I|medicines without your doctor's approval.||
2443|173|I|   Some products that may interact with this drug are: other||
2443|174|I|drugs that can cause bleeding/bruising (including antiplatelet||
2443|175|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
2443|176|I|"blood thinners" such as warfarin/dabigatran).||
2443|177|I|   Aspirin can increase the risk of bleeding when used with this||
2443|178|I|medication. However, if your doctor has told you to take low-dose||
2443|179|I|aspirin to prevent heart attack or stroke (usually 81-162||
2443|180|I|milligrams a day), you should keep taking the aspirin unless your||
2443|181|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2443|182|I|details.||
2443|183|I|   Other medications can affect the removal of ibrutinib from||
2443|184|I|your body, which may affect how ibrutinib works. Examples include||
2443|185|I|azole antifungals (such as itraconazole, ketoconazole),||
2443|186|I|nefazodone, St. John's wort, macrolide antibiotics (such as||
2443|187|I|erythromycin, clarithromycin), rifamycins (such as rifampin,||
2443|188|I|rifabutin), ritonavir, certain drugs used to treat seizures (such||
2443|189|I|as carbamazepine, phenytoin), among others.||
2443|190|B|||
2443|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2443|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2443|193|O|poison control center right away. US residents can call||
2443|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2443|195|B|||
2443|196|N|NOTES:  Do not share this medication with others.||
2443|197|N|   Lab and/or medical tests (such as complete blood count,||
2443|198|N|kidney/liver/heart function, heart rate, uric acid) should be||
2443|199|N|done while you are taking this medication. Keep all medical and||
2443|200|N|lab appointments. Consult your doctor for more details.||
2443|201|B|||
2443|202|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2443|203|D|remember. If you don't remember until the next day, skip the||
2443|204|D|missed dose. Take your next dose at the regular time. Do not||
2443|205|D|double the dose to catch up.||
2443|206|B|||
2443|207|R|STORAGE:  Store in the original container in the refrigerator or||
2443|208|R|at room temperature. Do not freeze. Once the bottle is opened,||
2443|209|R|this medication expires after 60 days. Keep all medications away||
2443|210|R|from children and pets.||
2443|211|R|   Do not flush medications down the toilet or pour them into a||
2443|212|R|drain unless instructed to do so. Properly discard this product||
2443|213|R|when it is expired or no longer needed. Consult your pharmacist||
2443|214|R|or local waste disposal company.||
2443|215|B|||
2443|216|M|MEDICAL ALERT:  Your condition can cause complications in a||
2443|217|M|medical emergency. For information about enrolling in MedicAlert,||
2443|218|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2443|219|B|||
2443|220|A|Information last revised April 2025.||
2443|221|A|Copyright(c) 2025 First Databank, Inc.||
2443|222|B|||
2444|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2444|002|Z|does NOT have all possible information about this product. This||
2444|003|Z|information does not assure that this product is safe, effective,||
2444|004|Z|or appropriate for you. This information is not individual||
2444|005|Z|medical advice and does not substitute for the advice of your||
2444|006|Z|health care professional. Always ask your health care||
2444|007|Z|professional for complete information about this product and your||
2444|008|Z|specific health needs.||
2444|009|B|||
2444|010|T|OLIPUDASE ALFA - INJECTION||
2444|011|F|(oh-LIP-ue-dase)||
2444|012|B|||
2444|013|C|COMMON BRAND NAME(S): Xenpozyme||
2444|014|B|||
2444|015|W|WARNING:  This medication may cause very serious allergic or||
2444|016|W|infusion reactions. Your doctor may prescribe other medications||
2444|017|W|(such as acetaminophen, antihistamines, corticosteroids) before||
2444|018|W|each treatment to help prevent these side effects. Get medical||
2444|019|W|help right away if you have any symptoms of a serious allergic||
2444|020|W|reaction or infusion reactions such as rash, hives,||
2444|021|W|redness/itching/swelling (especially of the face/tongue/throat),||
2444|022|W|severe dizziness, trouble breathing, or fever. Your doctor may||
2444|023|W|slow down or stop your treatment for some time.||
2444|024|B|||
2444|025|U|USES:  This medication is used to treat symptoms due to a certain||
2444|026|U|inherited disorder (acid sphingomyelinase deficiency-ASMD). This||
2444|027|U|condition causes buildup of a fatty substance called||
2444|028|U|sphingomyelin in various parts of the body. Olipudase alfa is an||
2444|029|U|enzyme that helps break down sphingomyelin. It is not a cure for||
2444|030|U|ASMD, but it can help decrease some symptoms caused by this||
2444|031|U|disorder such as enlarged spleen and liver.||
2444|032|B|||
2444|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2444|034|H|from your pharmacist before you start using olipudase alfa and||
2444|035|H|each time you get a refill. If you have any questions, ask your||
2444|036|H|doctor or pharmacist.||
2444|037|H|   This medication is given by slow injection into a vein as||
2444|038|H|directed by your doctor. The first 2 doses are usually given 1||
2444|039|H|week apart, followed by injections every 2 weeks. To reduce your||
2444|040|H|risk of side effects, your doctor may direct you to start this||
2444|041|H|medication at a low dose and gradually increase your dose.||
2444|042|H|   If you are using this medication at home, learn all||
2444|043|H|preparation and usage instructions from your health care||
2444|044|H|professional. Before using, check this product for particles or||
2444|045|H|discoloration. If either is present, do not use the liquid. Learn||
2444|046|H|how to store and discard medical supplies safely.||
2444|047|H|   The dosage is based on your medical condition, weight, and||
2444|048|H|response to treatment.||
2444|049|H|   To get the most benefit, do not miss any doses. To help you||
2444|050|H|remember, mark your calendar with a reminder.||
2444|051|H|   Tell your doctor if your condition does not get better or if||
2444|052|H|it gets worse.||
2444|053|B|||
2444|054|S|SIDE EFFECTS:  See also Warning section.||
2444|055|S|   Pain/redness/swelling at the infusion site, headache,||
2444|056|S|muscle/joint pain, tiredness, watering eyes, itching, nausea,||
2444|057|S|vomiting, or diarrhea may occur. If any of these effects last or||
2444|058|S|get worse, tell your doctor or pharmacist promptly.||
2444|059|S|   Remember that this medication has been prescribed because your||
2444|060|S|doctor has judged that the benefit to you is greater than the||
2444|061|S|risk of side effects. Many people using this medication do not||
2444|062|S|have serious side effects.||
2444|063|S|   Tell your doctor right away if you have any serious side||
2444|064|S|effects, including: signs of liver problems (nausea/vomiting that||
2444|065|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
2444|066|S|eyes/skin, dark urine).||
2444|067|S|   This is not a complete list of possible side effects. If you||
2444|068|S|notice other effects not listed above, contact your doctor or||
2444|069|S|pharmacist.||
2444|070|S|   In the US -||
2444|071|S|   Call your doctor for medical advice about side effects. You||
2444|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2444|073|S|www.fda.gov/medwatch.||
2444|074|S|   In Canada - Call your doctor for medical advice about side||
2444|075|S|effects. You may report side effects to Health Canada at||
2444|076|S|1-866-234-2345.||
2444|077|B|||
2444|078|P|PRECAUTIONS:  Before using olipudase alfa, tell your doctor or||
2444|079|P|pharmacist if you are allergic to it; or if you have any other||
2444|080|P|allergies. This product may contain inactive ingredients, which||
2444|081|P|can cause allergic reactions or other problems. Talk to your||
2444|082|P|pharmacist for more details.||
2444|083|P|   Before using this medication, tell your doctor or pharmacist||
2444|084|P|your medical history.||
2444|085|P|   Before having surgery, tell your doctor or dentist about all||
2444|086|P|the products you use (including prescription drugs,||
2444|087|P|nonprescription drugs, and herbal products).||
2444|088|P|   Children may be more sensitive to the side effects of this||
2444|089|P|drug, especially allergic and infusion reactions.||
2444|090|P|   Tell your doctor if you are pregnant or plan to become||
2444|091|P|pregnant. You should not become pregnant while using olipudase||
2444|092|P|alfa. Olipudase alfa may harm an unborn baby. Your doctor should||
2444|093|P|order a pregnancy test before you start this medication. Ask||
2444|094|P|about reliable forms of birth control while using this medication||
2444|095|P|and for 14 days after the last dose. If you become pregnant, talk||
2444|096|P|to your doctor right away about the risks and benefits of this||
2444|097|P|medication.||
2444|098|P|   It is unknown if this medication passes into breast milk.||
2444|099|P|Consult your doctor before breastfeeding.||
2444|100|B|||
2444|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2444|102|I|medications work or increase your risk for serious side effects.||
2444|103|I|This document does not contain all possible drug interactions.||
2444|104|I|Keep a list of all the products you use (including||
2444|105|I|prescription/nonprescription drugs and herbal products) and share||
2444|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
2444|107|I|the dosage of any medicines without your doctor's approval.||
2444|108|B|||
2444|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2444|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2444|111|O|poison control center right away. US residents can call||
2444|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2444|113|B|||
2444|114|N|NOTES:  Do not share this medication with others.||
2444|115|N|   Lab and/or medical tests (such as liver and spleen||
2444|116|N|measurements, complete blood counts) should be done while you are||
2444|117|N|using this medication. Keep all medical and lab appointments.||
2444|118|B|||
2444|119|D|MISSED DOSE:  It is important to get each dose of this medication||
2444|120|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2444|121|D|right away for a new dosing schedule.||
2444|122|B|||
2444|123|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
2444|124|R|medications away from children and pets.||
2444|125|R|   Do not flush medications down the toilet or pour them into a||
2444|126|R|drain unless instructed to do so. Properly discard this product||
2444|127|R|when it is expired or no longer needed. Consult your pharmacist||
2444|128|R|or local waste disposal company.||
2444|129|B|||
2444|130|A|Information last revised December 2024.||
2444|131|A|Copyright(c) 2025 First Databank, Inc.||
2444|132|B|||
2445|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2445|002|Z|does NOT have all possible information about this product. This||
2445|003|Z|information does not assure that this product is safe, effective,||
2445|004|Z|or appropriate for you. This information is not individual||
2445|005|Z|medical advice and does not substitute for the advice of your||
2445|006|Z|health care professional. Always ask your health care||
2445|007|Z|professional for complete information about this product and your||
2445|008|Z|specific health needs.||
2445|009|B|||
2445|010|T|DEUCRAVACITINIB - ORAL||
2445|011|F|(due-KRAV-a-SYE-ti-nib)||
2445|012|B|||
2445|013|C|COMMON BRAND NAME(S): Sotyktu||
2445|014|B|||
2445|015|U|USES:  This medication is used to treat a certain type of skin||
2445|016|U|condition (moderate to severe plaque psoriasis). Deucravacitinib||
2445|017|U|belongs to a class of drugs known as kinase inhibitors. It may||
2445|018|U|help to reduce the redness, thickening, and scaling of the skin||
2445|019|U|that occurs with this condition.||
2445|020|B|||
2445|021|H|HOW TO USE:  Read the Medication Guide provided by your||
2445|022|H|pharmacist before you start taking deucravacitinib and each time||
2445|023|H|you get a refill. If you have any questions, ask your doctor or||
2445|024|H|pharmacist.||
2445|025|H|   Take this medication by mouth with or without food as directed||
2445|026|H|by your doctor, usually once daily. Do not crush, chew, or split||
2445|027|H|the tablet.||
2445|028|H|   Use this medication regularly to get the most benefit from it.||
2445|029|H|To help you remember, take it at the same time each day.||
2445|030|H|   Do not increase your dose or use this drug more often or for||
2445|031|H|longer than prescribed. Your condition will not improve any||
2445|032|H|faster, and your risk of side effects will increase.||
2445|033|H|   Tell your doctor if your condition does not get better or if||
2445|034|H|it gets worse.||
2445|035|B|||
2445|036|S|SIDE EFFECTS:  Mouth sores or small red bumps on the skin||
2445|037|S|(folliculitis) may occur. If either of these effects lasts or||
2445|038|S|gets worse, tell your doctor or pharmacist promptly.||
2445|039|S|   Remember that this medication has been prescribed because your||
2445|040|S|doctor has judged that the benefit to you is greater than the||
2445|041|S|risk of side effects. Many people using this medication do not||
2445|042|S|have serious side effects.||
2445|043|S|   Tell your doctor right away if you have any serious side||
2445|044|S|effects, including: unusual lumps/growths, unexplained weight||
2445|045|S|loss, muscle pain/tenderness/weakness (especially with fever or||
2445|046|S|unusual tiredness), signs of kidney problems (such as change in||
2445|047|S|the amount of urine), signs of liver disease (such as||
2445|048|S|nausea/vomiting that doesn't stop, loss of appetite,||
2445|049|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2445|050|S|   This medication may lower your ability to fight infections.||
2445|051|S|This may make you more likely to get a serious (rarely fatal)||
2445|052|S|infection or make any infection you have worse. Tell your doctor||
2445|053|S|right away if you have any signs of infection (such as sore||
2445|054|S|throat that doesn't go away, fever, chills, non-healing skin||
2445|055|S|sores).||
2445|056|S|   A very serious allergic reaction to this drug is rare.||
2445|057|S|However, get medical help right away if you notice any symptoms||
2445|058|S|of a serious allergic reaction, including: rash, itching/swelling||
2445|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2445|060|S|breathing.||
2445|061|S|   This is not a complete list of possible side effects. If you||
2445|062|S|notice other effects not listed above, contact your doctor or||
2445|063|S|pharmacist.||
2445|064|S|   In the US -||
2445|065|S|   Call your doctor for medical advice about side effects. You||
2445|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2445|067|S|www.fda.gov/medwatch.||
2445|068|S|   In Canada - Call your doctor for medical advice about side||
2445|069|S|effects. You may report side effects to Health Canada at||
2445|070|S|1-866-234-2345.||
2445|071|B|||
2445|072|P|PRECAUTIONS:  Before taking deucravacitinib, tell your doctor or||
2445|073|P|pharmacist if you are allergic to it; or if you have any other||
2445|074|P|allergies. This product may contain inactive ingredients, which||
2445|075|P|can cause allergic reactions or other problems. Talk to your||
2445|076|P|pharmacist for more details.||
2445|077|P|   Before using this medication, tell your doctor or pharmacist||
2445|078|P|your medical history, especially of: past/recent/current||
2445|079|P|infections (such as tuberculosis, herpes zoster, HIV infection),||
2445|080|P|liver disease (such as hepatitis B or C), cancer, high levels of||
2445|081|P|fats/triglycerides in the blood.||
2445|082|P|   Deucravacitinib can make you more likely to get infections or||
2445|083|P|may make current infections worse. Stay away from anyone who has||
2445|084|P|an infection that may easily spread (such as chickenpox,||
2445|085|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2445|086|P|exposed to an infection or for more details.||
2445|087|P|   Tell your health care professional that you are using||
2445|088|P|deucravacitinib before having any immunizations/vaccinations.||
2445|089|P|Avoid contact with people who have recently received live||
2445|090|P|vaccines (such as flu vaccine inhaled through the nose).||
2445|091|P|   Before having surgery, tell your doctor or dentist about all||
2445|092|P|the products you use (including prescription drugs,||
2445|093|P|nonprescription drugs, and herbal products).||
2445|094|P|   Older adults may be at greater risk for infections while using||
2445|095|P|this drug.||
2445|096|P|   During pregnancy, this medication should be used only when||
2445|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
2445|098|P|   It is unknown if this medication passes into breast milk.||
2445|099|P|Consult your doctor before breastfeeding.||
2445|100|B|||
2445|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2445|102|I|medications work or increase your risk for serious side effects.||
2445|103|I|This document does not contain all possible drug interactions.||
2445|104|I|Keep a list of all the products you use (including||
2445|105|I|prescription/nonprescription drugs and herbal products) and share||
2445|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
2445|107|I|the dosage of any medicines without your doctor's approval.||
2445|108|B|||
2445|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2445|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2445|111|O|poison control center right away. US residents can call||
2445|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2445|113|B|||
2445|114|N|NOTES:  Do not share this medication with others.||
2445|115|N|   Lab and/or medical tests (such as complete blood count,||
2445|116|N|kidney/liver function, triglyceride levels) should be done while||
2445|117|N|you are using this medication. Keep all medical and lab||
2445|118|N|appointments.||
2445|119|B|||
2445|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2445|121|D|remember. If it is near the time of the next dose, skip the||
2445|122|D|missed dose. Take your next dose at the regular time. Do not||
2445|123|D|double the dose to catch up.||
2445|124|B|||
2445|125|R|STORAGE:  Store at room temperature away from light and moisture.||
2445|126|R|Do not store in the bathroom. Keep all medications away from||
2445|127|R|children and pets.||
2445|128|R|   Do not flush medications down the toilet or pour them into a||
2445|129|R|drain unless instructed to do so. Properly discard this product||
2445|130|R|when it is expired or no longer needed. Consult your pharmacist||
2445|131|R|or local waste disposal company.||
2445|132|B|||
2445|133|A|Information last revised April 2025.||
2445|134|A|Copyright(c) 2025 First Databank, Inc.||
2445|135|B|||
2446|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2446|002|Z|does NOT have all possible information about this product. This||
2446|003|Z|information does not assure that this product is safe, effective,||
2446|004|Z|or appropriate for you. This information is not individual||
2446|005|Z|medical advice and does not substitute for the advice of your||
2446|006|Z|health care professional. Always ask your health care||
2446|007|Z|professional for complete information about this product and your||
2446|008|Z|specific health needs.||
2446|009|B|||
2446|010|T|ELIVALDOGENE AUTOTEMCEL - INJECTION||
2446|011|F|(EL-i-VAL-doe-jeen AW-toe-TEM-sel)||
2446|012|B|||
2446|013|C|COMMON BRAND NAME(S): Skysona||
2446|014|B|||
2446|015|W|WARNING:  This product may increase your risk of developing blood||
2446|016|W|cancer. Blood cancer may occur many years after your treatment.||
2446|017|W|Your doctor should do regular blood tests for at least 15 years||
2446|018|W|to monitor for any changes to your blood. Tell your doctor right||
2446|019|W|away if you develop symptoms of blood cancer, such as unusual||
2446|020|W|tiredness, easy bruising/bleeding, or swollen lymph nodes.||
2446|021|B|||
2446|022|U|USES:  Elivaldogene autotemcel is used to treat a certain||
2446|023|U|inherited brain disorder (cerebral adrenoleukodystrophy-CALD). In||
2446|024|U|this condition, your body does not make enough of a certain||
2446|025|U|protein that is needed to break down the very long chain fatty||
2446|026|U|acids in the brain. This type of treatment is known as gene||
2446|027|U|therapy. Your elivaldogene autotemcel is made from your own blood||
2446|028|U|stem cells and is given only to you. The blood stem cells have||
2446|029|U|been changed to have genes that work properly so that your body||
2446|030|U|can break down the very long chain fatty acids in the brain. This||
2446|031|U|may help to slow the progression of CALD.||
2446|032|B|||
2446|033|H|HOW TO USE:  Read the Medication Guide from your pharmacist||
2446|034|H|before you receive this product. If you have any questions, ask||
2446|035|H|your doctor or pharmacist.||
2446|036|H|   Your doctor will give you other medications (such as||
2446|037|H|chemotherapy) before treatment with this product to prepare your||
2446|038|H|body.||
2446|039|H|   This product is given by slow injection into a vein as||
2446|040|H|directed by your doctor. To decrease the risk of side effects,||
2446|041|H|your doctor may also give you other medications before injecting||
2446|042|H|elivaldogene autotemcel. The dosage is based on your medical||
2446|043|H|condition and weight.||
2446|044|H|   After you receive this product, you will stay in the hospital||
2446|045|H|for about 2 months so your doctor can check to see if your||
2446|046|H|treatment is working and help you manage any side effects.||
2446|047|B|||
2446|048|S|SIDE EFFECTS:  See also Warning section.||
2446|049|S|   Nausea, vomiting, or decreased appetite may occur. If any of||
2446|050|S|these effects last or get worse, tell your doctor or pharmacist||
2446|051|S|promptly.||
2446|052|S|   Pain or sores in the mouth and throat may occur. Brush your||
2446|053|S|teeth carefully/gently, avoid using mouthwash that contains||
2446|054|S|alcohol, and rinse your mouth often with cool water mixed with||
2446|055|S|baking soda or salt. It may also be best to eat soft, moist||
2446|056|S|foods.||
2446|057|S|   Remember that this medication has been prescribed because your||
2446|058|S|doctor has judged that the benefit to you is greater than the||
2446|059|S|risk of side effects. Many people using this medication do not||
2446|060|S|have serious side effects.||
2446|061|S|   Treatment with this product may lead to a low number of blood||
2446|062|S|cells such as red cells, white cells, and platelets. This effect||
2446|063|S|can cause anemia, decrease your body's ability to fight an||
2446|064|S|infection, or cause easy bruising/bleeding. Tell your doctor||
2446|065|S|right away if you develop any of the following symptoms: unusual||
2446|066|S|tiredness, pale skin, signs of infection (such as sore throat||
2446|067|S|that doesn't go away, fever, chills), easy bruising/bleeding.||
2446|068|S|   A very serious allergic reaction to this drug is rare.||
2446|069|S|However, get medical help right away if you notice any symptoms||
2446|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2446|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2446|072|S|breathing.||
2446|073|S|   This is not a complete list of possible side effects. If you||
2446|074|S|notice other effects not listed above, contact your doctor or||
2446|075|S|pharmacist.||
2446|076|S|   In the US -||
2446|077|S|   Call your doctor for medical advice about side effects. You||
2446|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2446|079|S|www.fda.gov/medwatch.||
2446|080|S|   In Canada - Call your doctor for medical advice about side||
2446|081|S|effects. You may report side effects to Health Canada at||
2446|082|S|1-866-234-2345.||
2446|083|B|||
2446|084|P|PRECAUTIONS:  Before receiving elivaldogene autotemcel, tell your||
2446|085|P|doctor or pharmacist if you have any allergies. This product may||
2446|086|P|contain inactive ingredients, which can cause allergic reactions||
2446|087|P|or other problems. Talk to your pharmacist for more details.||
2446|088|P|   Before using this product, tell your doctor or pharmacist your||
2446|089|P|medical history, especially of: past/current/recent infection||
2446|090|P|(including hepatitis, HIV), kidney problems, liver problems.||
2446|091|P|   This product can make you more likely to get infections or may||
2446|092|P|make current infections worse. Stay away from anyone who has an||
2446|093|P|infection that may easily spread (such as chickenpox, COVID-19,||
2446|094|P|measles, flu). Talk to your doctor if you have been exposed to an||
2446|095|P|infection or for more details.||
2446|096|P|   Tell your health care professional that you have received this||
2446|097|P|product before having any immunizations/vaccinations. Avoid||
2446|098|P|contact with people who have recently received live vaccines||
2446|099|P|(such as flu vaccine inhaled through the nose).||
2446|100|P|   To lower the chance of getting cut, bruised, or injured, use||
2446|101|P|caution with sharp objects like razors and nail cutters, and||
2446|102|P|avoid activities such as contact sports.||
2446|103|P|   Before having surgery, tell your doctor or dentist about all||
2446|104|P|the products you use (including prescription drugs,||
2446|105|P|nonprescription drugs, and herbal products).||
2446|106|P|   This product is not usually used by women. It is unlikely to||
2446|107|P|be used during pregnancy or breastfeeding. Consult your doctor if||
2446|108|P|you have any questions about this product.||
2446|109|B|||
2446|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2446|111|I|medications work or increase your risk for serious side effects.||
2446|112|I|This document does not contain all possible drug interactions.||
2446|113|I|Keep a list of all the products you use (including||
2446|114|I|prescription/nonprescription drugs and herbal products) and share||
2446|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
2446|116|I|the dosage of any medicines without your doctor's approval.||
2446|117|I|   Certain medications (such as anti-retroviral drugs,||
2446|118|I|hydroxyurea) may interfere with how this product is made. If you||
2446|119|I|are using any of these, your doctor may have you stop taking them||
2446|120|I|for at least 1 month before the procedure to collect your blood||
2446|121|I|stem cells.||
2446|122|I|   This medication may interfere with certain lab tests (such as||
2446|123|I|some HIV tests), possibly causing false test results. Make sure||
2446|124|I|lab personnel and all your doctors know you use this product.||
2446|125|B|||
2446|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2446|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2446|128|O|poison control center right away. US residents can call||
2446|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2446|130|B|||
2446|131|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
2446|132|N|should be done before and after you receive this product. Keep||
2446|133|N|all medical and lab appointments.||
2446|134|N|   After receiving this treatment, do not donate blood, organs,||
2446|135|N|tissues, or cells.||
2446|136|B|||
2446|137|D|MISSED DOSE:  Not applicable.||
2446|138|B|||
2446|139|R|STORAGE:  Not applicable. This product is given in a hospital or||
2446|140|R|clinic and will not be stored at home.||
2446|141|B|||
2446|142|M|MEDICAL ALERT:  Your condition can cause complications in a||
2446|143|M|medical emergency. For information about enrolling in MedicAlert,||
2446|144|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2446|145|B|||
2446|146|A|Information last revised May 2025.||
2446|147|A|Copyright(c) 2025 First Databank, Inc.||
2446|148|B|||
2447|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2447|002|Z|does NOT have all possible information about this product. This||
2447|003|Z|information does not assure that this product is safe, effective,||
2447|004|Z|or appropriate for you. This information is not individual||
2447|005|Z|medical advice and does not substitute for the advice of your||
2447|006|Z|health care professional. Always ask your health care||
2447|007|Z|professional for complete information about this product and your||
2447|008|Z|specific health needs.||
2447|009|B|||
2447|010|T|EFLAPEGRASTIM - INJECTION||
2447|011|F|(e-FLAP-e-GRA-stim)||
2447|012|B|||
2447|013|C|COMMON BRAND NAME(S): Rolvedon||
2447|014|B|||
2447|015|U|USES:  Eflapegrastim is a man-made version of a certain natural||
2447|016|U|substance made by your body. It is used to help your body make||
2447|017|U|more white blood cells. White blood cells are important to help||
2447|018|U|you fight off infections. Eflapegrastim is given to people whose||
2447|019|U|ability to make white blood cells is reduced due to chemotherapy.||
2447|020|B|||
2447|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2447|022|H|Instructions for Use if available from your pharmacist before you||
2447|023|H|start using eflapegrastim and each time you get a refill. Ask||
2447|024|H|your health care professional how to prepare and use this||
2447|025|H|medication. If you have any questions, ask your doctor or||
2447|026|H|pharmacist.||
2447|027|H|   Inject this medication under the skin as directed by your||
2447|028|H|doctor, usually once during each chemotherapy cycle. However, it||
2447|029|H|should not be given within 14 days before or 24 hours after||
2447|030|H|chemotherapy. Ask your doctor for specific directions about when||
2447|031|H|to use this medication.||
2447|032|H|    Take the medication out of the refrigerator at least 30||
2447|033|H|minutes before you inject it to allow it to reach room||
2447|034|H|temperature. Do not warm up this medication any other way (for||
2447|035|H|example, do not heat it in the microwave or place it in hot||
2447|036|H|water). Do not shake the medication. Before using, check this||
2447|037|H|product for particles or discoloration. If either is present, do||
2447|038|H|not use the liquid. Before injecting each dose, clean the skin||
2447|039|H|you are going to inject into (the injection site) with rubbing||
2447|040|H|alcohol. Change the injection site each time to lessen injury||
2447|041|H|under the skin. To lessen bruising, do not rub the injection site||
2447|042|H|after a shot. Learn how to store and discard medical supplies||
2447|043|H|safely.||
2447|044|B|||
2447|045|S|SIDE EFFECTS:  Aching or pain in the bones and muscles may occur.||
2447|046|S|Taking a non-aspirin pain reliever such as acetaminophen may help||
2447|047|S|relieve pain. Ask your doctor or pharmacist for more details.||
2447|048|S|Redness, swelling, itching, or bruising at the injection site may||
2447|049|S|also occur. If any of these effects last or get worse, tell your||
2447|050|S|doctor or pharmacist promptly.||
2447|051|S|   Remember that this medication has been prescribed because your||
2447|052|S|doctor has judged that the benefit to you is greater than the||
2447|053|S|risk of side effects. Many people using this medication do not||
2447|054|S|have serious side effects.||
2447|055|S|   Tell your doctor right away if you have any serious side||
2447|056|S|effects, including: pink/bloody urine, easy bleeding/bruising,||
2447|057|S|fever, fast heartbeat, purple/red spots on your skin, back pain.||
2447|058|S|   Get medical help right away if you have any very serious side||
2447|059|S|effects, including: breathing problems (such as shortness of||
2447|060|S|breath, fast breathing), unusual decrease in urination, unusual||
2447|061|S|tiredness, swelling/puffiness of the body.||
2447|062|S|   Rarely, serious (possibly fatal) damage to the spleen may||
2447|063|S|occur. Get medical help right away if you develop||
2447|064|S|stomach/abdominal pain or shoulder pain.||
2447|065|S|   Rarely, this medication may increase the risk of developing a||
2447|066|S|certain bone marrow disorder (myelodysplastic syndrome-MDS) or||
2447|067|S|blood cancer (acute myeloid leukemia-AML) in people with breast||
2447|068|S|or lung cancer who are receiving chemotherapy/radiation. Ask your||
2447|069|S|doctor for more details.||
2447|070|S|   A very serious allergic reaction to this drug is rare.||
2447|071|S|However, get medical help right away if you notice any symptoms||
2447|072|S|of a serious allergic reaction, including: rash, itching/swelling||
2447|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2447|074|S|breathing.||
2447|075|S|   This is not a complete list of possible side effects. If you||
2447|076|S|notice other effects not listed above, contact your doctor or||
2447|077|S|pharmacist.||
2447|078|S|   In the US -||
2447|079|S|   Call your doctor for medical advice about side effects. You||
2447|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2447|081|S|www.fda.gov/medwatch.||
2447|082|S|   In Canada - Call your doctor for medical advice about side||
2447|083|S|effects. You may report side effects to Health Canada at||
2447|084|S|1-866-234-2345.||
2447|085|B|||
2447|086|P|PRECAUTIONS:  Before using eflapegrastim, tell your doctor or||
2447|087|P|pharmacist if you are allergic to it; or to pegfilgrastim or||
2447|088|P|filgrastim products; or if you have any other allergies. This||
2447|089|P|product may contain inactive ingredients, which can cause||
2447|090|P|allergic reactions or other problems. Talk to your pharmacist for||
2447|091|P|more details.||
2447|092|P|   Before using this medication, tell your doctor or pharmacist||
2447|093|P|your medical history, especially of: sickle cell disease, spleen||
2447|094|P|problems.||
2447|095|P|   Before having surgery, tell your doctor or dentist about all||
2447|096|P|the products you use (including prescription drugs,||
2447|097|P|nonprescription drugs, and herbal products).||
2447|098|P|   During pregnancy, this medication should be used only when||
2447|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
2447|100|P|   It is unknown if this medication passes into breast milk.||
2447|101|P|Consult your doctor before breastfeeding.||
2447|102|B|||
2447|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2447|104|I|medications work or increase your risk for serious side effects.||
2447|105|I|This document does not contain all possible drug interactions.||
2447|106|I|Keep a list of all the products you use (including||
2447|107|I|prescription/nonprescription drugs and herbal products) and share||
2447|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
2447|109|I|the dosage of any medicines without your doctor's approval.||
2447|110|I|   This medication may interfere with certain lab tests (such as||
2447|111|I|bone imaging tests), possibly causing false test results. Make||
2447|112|I|sure lab personnel and all your doctors know you use this drug.||
2447|113|B|||
2447|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2447|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2447|116|O|poison control center right away. US residents can call||
2447|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2447|118|B|||
2447|119|N|NOTES:  Do not share this medication with others.||
2447|120|N|   Lab and/or medical tests (such as complete blood count, kidney||
2447|121|N|function) should be done while you are using this medication.||
2447|122|N|Keep all medical and lab appointments. Consult your doctor for||
2447|123|N|more details.||
2447|124|B|||
2447|125|D|MISSED DOSE:  It is important to get each dose of this medication||
2447|126|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2447|127|D|right away for a new dosing schedule. Do not double the dose to||
2447|128|D|catch up.||
2447|129|B|||
2447|130|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2447|131|R|medication in the original package to protect from light. If the||
2447|132|R|medication is stored at room temperature, discard after 12 hours.||
2447|133|R|Keep all medications away from children and pets.||
2447|134|R|   Do not flush medications down the toilet or pour them into a||
2447|135|R|drain unless instructed to do so. Properly discard this product||
2447|136|R|when it is expired or no longer needed. Consult your pharmacist||
2447|137|R|or local waste disposal company.||
2447|138|B|||
2447|139|A|Information last revised October 2024.||
2447|140|A|Copyright(c) 2025 First Databank, Inc.||
2447|141|B|||
2448|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2448|002|Z|does NOT have all possible information about this product. This||
2448|003|Z|information does not assure that this product is safe, effective,||
2448|004|Z|or appropriate for you. This information is not individual||
2448|005|Z|medical advice and does not substitute for the advice of your||
2448|006|Z|health care professional. Always ask your health care||
2448|007|Z|professional for complete information about this product and your||
2448|008|Z|specific health needs.||
2448|009|B|||
2448|010|T|DEXTROMETHORPHAN/BUPROPION EXTENDED-RELEASE - ORAL||
2448|011|F|(DEX-troe-meth-OR-fan/bue-PROE-pee-on)||
2448|012|B|||
2448|013|C|COMMON BRAND NAME(S): Auvelity||
2448|014|B|||
2448|015|W|WARNING:  Antidepressant medications are used to treat a variety||
2448|016|W|of conditions, including depression and other mental/mood||
2448|017|W|disorders. These medications can help prevent suicidal||
2448|018|W|thoughts/attempts and provide other important benefits. However,||
2448|019|W|studies have shown that a small number of people (especially||
2448|020|W|people younger than 25) who take antidepressants for any||
2448|021|W|condition may experience worsening depression, other mental/mood||
2448|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
2448|023|W|talk with the doctor about the risks and benefits of||
2448|024|W|antidepressant medication (especially for people younger than||
2448|025|W|25), even if treatment is not for a mental/mood condition.||
2448|026|W|   Tell the doctor right away if you notice worsening||
2448|027|W|depression/other psychiatric conditions, unusual behavior changes||
2448|028|W|(including possible suicidal thoughts/attempts), or other||
2448|029|W|mental/mood changes (including new/worsening anxiety, panic||
2448|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2448|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
2448|032|W|especially watchful for these symptoms when a new antidepressant||
2448|033|W|is started or when the dose is changed.||
2448|034|B|||
2448|035|U|USES:  This combination medication is used to treat depression.||
2448|036|U|Dextromethorphan/bupropion works by helping to restore the||
2448|037|U|balance of certain natural substances (dopamine, norepinephrine)||
2448|038|U|in the brain.||
2448|039|B|||
2448|040|H|HOW TO USE:  Read the Medication Guide provided by your||
2448|041|H|pharmacist before you start using this medication and each time||
2448|042|H|you get a refill. If you have any questions, ask your doctor or||
2448|043|H|pharmacist.||
2448|044|H|   Take this medication by mouth with or without food as directed||
2448|045|H|by your doctor, usually starting with once daily in the morning||
2448|046|H|for 3 days, then increasing to twice daily. If you are taking||
2448|047|H|this medication twice daily, take your doses at least 8 hours||
2448|048|H|apart. The dosage is based on your medical condition, response to||
2448|049|H|treatment, and other medications you may be taking. Be sure to||
2448|050|H|tell your doctor and pharmacist about all the products you use||
2448|051|H|(including prescription drugs, nonprescription drugs, and herbal||
2448|052|H|products).||
2448|053|H|   Swallow the tablets whole. Do not crush, split, or chew the||
2448|054|H|tablets. Doing so can release all of the drug at once, increasing||
2448|055|H|the risk of side effects.||
2448|056|H|   Use this medication regularly to get the most benefit from it.||
2448|057|H|To help you remember, take it at the same time(s) each day.||
2448|058|H|   Do not stop taking this medication without consulting your||
2448|059|H|doctor. Some conditions may become worse when this drug is||
2448|060|H|suddenly stopped. Your dose may need to be gradually decreased.||
2448|061|H|   Tell your doctor if your condition does not get better or if||
2448|062|H|it gets worse.||
2448|063|B|||
2448|064|S|SIDE EFFECTS:  See also Warning section.||
2448|065|S|   Dry mouth, sore throat, dizziness, nausea, vomiting, ringing||
2448|066|S|in the ears, headache, decreased appetite, weight loss,||
2448|067|S|constipation, trouble sleeping, increased sweating, or sexual||
2448|068|S|function problems may occur. If any of these effects last or get||
2448|069|S|worse, tell your doctor or pharmacist promptly.||
2448|070|S|   Remember that this medication has been prescribed because your||
2448|071|S|doctor has judged that the benefit to you is greater than the||
2448|072|S|risk of side effects. Many people using this medication do not||
2448|073|S|have serious side effects.||
2448|074|S|   This medication may raise your blood pressure. Check your||
2448|075|S|blood pressure regularly and tell your doctor if the results are||
2448|076|S|high.||
2448|077|S|   Tell your doctor right away if you have any serious side||
2448|078|S|effects, including: fast/pounding/irregular heartbeat,||
2448|079|S|mental/mood changes (such as anxiety, agitation, confusion,||
2448|080|S|unusual behavior/thinking, memory loss).||
2448|081|S|   Stop taking this medication and get medical help right away if||
2448|082|S|any of these very serious side effects occur: seizure, eye||
2448|083|S|pain/swelling/redness, vision changes (such as seeing rainbows||
2448|084|S|around lights at night, blurred vision).||
2448|085|S|   A very serious allergic reaction to this drug is rare.||
2448|086|S|However, get medical help right away if you notice any symptoms||
2448|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2448|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2448|089|S|breathing.||
2448|090|S|   This is not a complete list of possible side effects. If you||
2448|091|S|notice other effects not listed above, contact your doctor or||
2448|092|S|pharmacist.||
2448|093|S|   In the US -||
2448|094|S|   Call your doctor for medical advice about side effects. You||
2448|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2448|096|S|www.fda.gov/medwatch.||
2448|097|S|   In Canada - Call your doctor for medical advice about side||
2448|098|S|effects. You may report side effects to Health Canada at||
2448|099|S|1-866-234-2345.||
2448|100|B|||
2448|101|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2448|102|P|pharmacist if you are allergic to dextromethorphan or bupropion;||
2448|103|P|or if you have any other allergies. This product may contain||
2448|104|P|inactive ingredients, which can cause allergic reactions or other||
2448|105|P|problems. Talk to your pharmacist for more details.||
2448|106|P|   Before using this medication, tell your doctor or pharmacist||
2448|107|P|your medical history, especially of: diabetes, heart problems||
2448|108|P|(such as previous heart attack), high blood pressure, glaucoma,||
2448|109|P|kidney problems, liver disease, substance use disorder (such as||
2448|110|P|overuse of or addiction to drugs/alcohol), seizures or conditions||
2448|111|P|that increase your risk of seizures (including brain/head injury,||
2448|112|P|brain tumor, eating disorders such as bulimia/anorexia nervosa),||
2448|113|P|stroke.||
2448|114|P|   This medication should not be used if you are suddenly||
2448|115|P|stopping regular use of sedatives (including benzodiazepines such||
2448|116|P|as lorazepam), drugs used to treat seizures, or alcohol. Doing so||
2448|117|P|may increase your risk of seizures.||
2448|118|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2448|119|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2448|120|P|machinery, or do anything that needs alertness until you can do||
2448|121|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2448|122|P|are using marijuana (cannabis). Alcohol can also increase your||
2448|123|P|risk of seizures.||
2448|124|P|   Before having surgery, tell your doctor or dentist about all||
2448|125|P|the products you use (including prescription drugs,||
2448|126|P|nonprescription drugs, and herbal products).||
2448|127|P|   Older adults may be more sensitive to the side effects of this||
2448|128|P|drug, especially dizziness. Dizziness can increase the risk of||
2448|129|P|falling.||
2448|130|P|   During pregnancy, this medication should be used only when||
2448|131|P|clearly needed. Since untreated mental/mood problems (such as||
2448|132|P|depression) can be a serious condition, do not stop taking this||
2448|133|P|medication unless directed by your doctor. If you are planning||
2448|134|P|pregnancy, become pregnant, or think you may be pregnant, talk to||
2448|135|P|your doctor right away about the benefits and risks of using this||
2448|136|P|medication during pregnancy.||
2448|137|P|   Dextromethorphan passes into breast milk. Bupropion passes||
2448|138|P|into breast milk and may have undesirable effects on a nursing||
2448|139|P|infant. Breastfeeding is not recommended while using this||
2448|140|P|medication and for 5 days after the last dose. Consult your||
2448|141|P|doctor before breastfeeding.||
2448|142|B|||
2448|143|I|DRUG INTERACTIONS:  See also Precautions section.||
2448|144|I|   Drug interactions may change how your medications work or||
2448|145|I|increase your risk for serious side effects. This document does||
2448|146|I|not contain all possible drug interactions. Keep a list of all||
2448|147|I|the products you use (including prescription/nonprescription||
2448|148|I|drugs and herbal products) and share it with your doctor and||
2448|149|I|pharmacist. Do not start, stop, or change the dosage of any||
2448|150|I|medicines without your doctor's approval.||
2448|151|I|   Some products that may interact with this drug are: pimozide,||
2448|152|I|thioridazine.||
2448|153|I|   Taking MAO inhibitors with this medication may cause a serious||
2448|154|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2448|155|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2448|156|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2448|157|I|selegiline, tranylcypromine) during treatment with this||
2448|158|I|medication. Most MAO inhibitors should also not be taken for two||
2448|159|I|weeks before and after treatment with this medication. Ask your||
2448|160|I|doctor when to start or stop taking this medication.||
2448|161|I|   This medication contains dextromethorphan and bupropion. Do||
2448|162|I|not take any other medications that contain dextromethorphan or||
2448|163|I|bupropion while taking this medication unless otherwise directed||
2448|164|I|by your doctor.||
2448|165|I|   This medication may interfere with certain lab/medical tests||
2448|166|I|(such as brain scan for Parkinson's disease, urine screening for||
2448|167|I|amphetamines), possibly causing false results. Make sure lab||
2448|168|I|personnel and all your doctors know you use this drug.||
2448|169|B|||
2448|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2448|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2448|172|O|poison control center right away. US residents can call||
2448|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2448|174|O|Symptoms of overdose may include: seizures, severe confusion,||
2448|175|O|hallucinations, rapid heart rate, loss of consciousness.||
2448|176|B|||
2448|177|N|NOTES:  Do not share this medication with others.||
2448|178|N|   Lab and/or medical tests (such as blood pressure, kidney/liver||
2448|179|N|function) may be done while you are taking this medication. Keep||
2448|180|N|all medical and lab appointments.||
2448|181|B|||
2448|182|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2448|183|D|next dose at the regular time. Do not double the dose to catch||
2448|184|D|up.||
2448|185|B|||
2448|186|R|STORAGE:  Store at room temperature away from light and moisture.||
2448|187|R|Do not store in the bathroom. Keep all medications away from||
2448|188|R|children and pets.||
2448|189|R|   Do not flush medications down the toilet or pour them into a||
2448|190|R|drain unless instructed to do so. Properly discard this product||
2448|191|R|when it is expired or no longer needed. Consult your pharmacist||
2448|192|R|or local waste disposal company.||
2448|193|B|||
2448|194|A|Information last revised July 2025.||
2448|195|A|Copyright(c) 2025 First Databank, Inc.||
2448|196|B|||
2449|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2449|002|Z|does NOT have all possible information about this product. This||
2449|003|Z|information does not assure that this product is safe, effective,||
2449|004|Z|or appropriate for you. This information is not individual||
2449|005|Z|medical advice and does not substitute for the advice of your||
2449|006|Z|health care professional. Always ask your health care||
2449|007|Z|professional for complete information about this product and your||
2449|008|Z|specific health needs.||
2449|009|B|||
2449|010|T|FUROSEMIDE - SUBCUTANEOUS INJECTION||
2449|011|F|(fure-OH-se-mide)||
2449|012|B|||
2449|013|C|COMMON BRAND NAME(S): Furoscix, Lasix ONYU||
2449|014|B|||
2449|015|U|USES:  This medication is used to reduce extra water in the body||
2449|016|U|in people with heart failure or kidney disease. Getting rid of||
2449|017|U|the extra water can improve symptoms such as trouble breathing or||
2449|018|U|swelling (edema). It can also decrease the strain on your heart||
2449|019|U|and blood vessels. This medication is known as a diuretic (like a||
2449|020|U|"water pill"). It works by increasing the amount of urine you||
2449|021|U|make. This injectable form of furosemide is not meant for||
2449|022|U|long-term use and is used when the drug cannot be taken by mouth.||
2449|023|B|||
2449|024|H|HOW TO USE:  Read the Instructions for use if available from your||
2449|025|H|pharmacist before you start using furosemide and each time you||
2449|026|H|get a refill. Ask your health care professional how to prepare||
2449|027|H|and use this medication. If you have any questions, ask your||
2449|028|H|doctor or pharmacist.||
2449|029|H|   This medication is given by injection under the skin with the||
2449|030|H|use of the on-body injector as directed by your doctor. The||
2449|031|H|on-body injector is applied to a clean, dry area of the abdomen.||
2449|032|H|   Before using, check this product for particles or||
2449|033|H|discoloration. If either is present, do not use the liquid.||
2449|034|H|Before applying the on-body injector, clean the skin you are||
2449|035|H|going to inject into (the injection site) with rubbing alcohol.||
2449|036|H|Change the injection site each time to lessen injury under the||
2449|037|H|skin. Do not apply to an area that is tender, broken, bruised,||
2449|038|H|red, or hardened. Learn how to store and discard medical supplies||
2449|039|H|safely.||
2449|040|H|   The on-body injector will infuse medication into your body for||
2449|041|H|over 5 hours. You should limit the amount of physical activity||
2449|042|H|you do while the on-body injector is in use to prevent it from||
2449|043|H|accidentally falling off. Do not get the on-body injector wet. It||
2449|044|H|is recommended not to ride in a car or fly in an airplane while||
2449|045|H|wearing the on-body injector. Keep the on-body injector at least||
2449|046|H|12 inches away from mobile phones, tablets, computers, or other||
2449|047|H|wireless devices.||
2449|048|H|    Do not reapply if the device accidentally falls off. Contact||
2449|049|H|your doctor right away if that happens.||
2449|050|H|   Tell your doctor if your condition lasts or gets worse.||
2449|051|B|||
2449|052|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, or blurred||
2449|053|S|vision may occur. If any of these effects last or get worse, tell||
2449|054|S|your doctor or pharmacist promptly.||
2449|055|S|   To reduce the risk of dizziness and lightheadedness, get up||
2449|056|S|slowly when rising from a sitting or lying position.||
2449|057|S|   Remember that this medication has been prescribed because your||
2449|058|S|doctor has judged that the benefit to you is greater than the||
2449|059|S|risk of side effects. Many people using this medication do not||
2449|060|S|have serious side effects.||
2449|061|S|   This medication may cause dehydration and electrolyte||
2449|062|S|imbalance. Tell your doctor right away if you have any symptoms||
2449|063|S|of dehydration or electrolyte imbalance, including unusual dry||
2449|064|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
2449|065|S|heartbeat, or confusion.||
2449|066|S|   Tell your doctor right away if you have any serious side||
2449|067|S|effects, including: new or worsening signs of kidney problems||
2449|068|S|(such as change in the amount of urine), fainting, hearing loss,||
2449|069|S|ringing in the ears, numbness/tingling of the arms/legs, signs of||
2449|070|S|liver problems (such as stomach/abdominal pain, yellowing||
2449|071|S|eyes/skin).||
2449|072|S|   A very serious allergic reaction to this drug is rare.||
2449|073|S|However, get medical help right away if you notice any symptoms||
2449|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2449|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2449|076|S|breathing.||
2449|077|S|   This is not a complete list of possible side effects. If you||
2449|078|S|notice other effects not listed above, contact your doctor or||
2449|079|S|pharmacist.||
2449|080|S|   In the US -||
2449|081|S|   Call your doctor for medical advice about side effects. You||
2449|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2449|083|S|www.fda.gov/medwatch.||
2449|084|S|   In Canada - Call your doctor for medical advice about side||
2449|085|S|effects. You may report side effects to Health Canada at||
2449|086|S|1-866-234-2345.||
2449|087|B|||
2449|088|P|PRECAUTIONS:  Before using furosemide, tell your doctor or||
2449|089|P|pharmacist if you are allergic to it; or if you have any other||
2449|090|P|allergies. This product may contain inactive ingredients (such as||
2449|091|P|medical adhesives), which can cause allergic reactions or other||
2449|092|P|problems. Talk to your pharmacist for more details.||
2449|093|P|   Before using this medication, tell your doctor or pharmacist||
2449|094|P|your medical history, especially of: kidney disease, liver||
2449|095|P|disease, gout, lupus.||
2449|096|P|   If you have diabetes, furosemide may make it harder to control||
2449|097|P|your blood sugar. Check your blood sugar regularly as directed||
2449|098|P|and share the results with your doctor.||
2449|099|P|   This drug may reduce the potassium levels in your blood. Ask||
2449|100|P|your doctor about adding potassium to your diet. Your doctor may||
2449|101|P|also prescribe a potassium supplement.||
2449|102|P|   This medication may make you more sensitive to the sun. Limit||
2449|103|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2449|104|P|sunscreen and wear protective clothing when outdoors. Tell your||
2449|105|P|doctor right away if you get sunburned or have skin||
2449|106|P|blisters/redness.||
2449|107|P|   This drug may make you dizzy or drowsy or cause blurred||
2449|108|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
2449|109|P|or drowsy. Do not drive, use machinery, or do anything that needs||
2449|110|P|alertness or clear vision until you can do it safely. Limit||
2449|111|P|alcoholic beverages. Talk to your doctor if you are using||
2449|112|P|marijuana (cannabis).||
2449|113|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
2449|114|P|and cause you to feel lightheaded. Tell your doctor if you have||
2449|115|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
2449|116|P|of fluids unless your doctor tells you not to.||
2449|117|P|   Before having surgery, tell your doctor or dentist about all||
2449|118|P|the products you use (including prescription drugs,||
2449|119|P|nonprescription drugs, and herbal products). Also, if you are||
2449|120|P|going to have an MRI test, tell testing personnel that you are||
2449|121|P|using this device.||
2449|122|P|   Older adults may be more sensitive to the side effects of this||
2449|123|P|drug, especially dizziness and water/mineral loss.||
2449|124|P|   During pregnancy, this medication should be used only when||
2449|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
2449|126|P|   This drug passes into breast milk. Consult your doctor before||
2449|127|P|breastfeeding.||
2449|128|B|||
2449|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2449|130|I|medications work or increase your risk for serious side effects.||
2449|131|I|This document does not contain all possible drug interactions.||
2449|132|I|Keep a list of all the products you use (including||
2449|133|I|prescription/nonprescription drugs and herbal products) and share||
2449|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
2449|135|I|the dosage of any medicines without your doctor's approval.||
2449|136|I|   Some products that may interact with this drug are:||
2449|137|I|desmopressin, ethacrynic acid, lithium.||
2449|138|I|   Some products have ingredients that could raise your blood||
2449|139|I|pressure or worsen your swelling. Tell your pharmacist what||
2449|140|I|products you are using, and ask how to use them safely||
2449|141|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
2449|142|I|ibuprofen/naproxen).||
2449|143|I|   This medication may interfere with certain lab tests (such as||
2449|144|I|thyroid hormone levels), possibly causing false test results.||
2449|145|I|Make sure lab personnel and all your doctors know you use this||
2449|146|I|drug.||
2449|147|B|||
2449|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2449|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2449|150|O|poison control center right away. US residents can call||
2449|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2449|152|O|Symptoms of overdose may include: a severe decrease in amount of||
2449|153|O|urine, weakness, fast/irregular heartbeat.||
2449|154|B|||
2449|155|N|NOTES:  Do not share this medication with others.||
2449|156|N|   Lab and/or medical tests (such as kidney function, blood||
2449|157|N|mineral levels such as sodium/potassium) should be done while you||
2449|158|N|are using this medication. Consult your doctor for more details.||
2449|159|B|||
2449|160|D|MISSED DOSE:  It is important to get each dose of this medication||
2449|161|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2449|162|D|right away for a new dosing schedule.||
2449|163|B|||
2449|164|R|STORAGE:  Store at room temperature away from light. Keep the||
2449|165|R|cartridge in the carton until ready to use. Do not refrigerate or||
2449|166|R|freeze. Keep all medications away from children and pets.||
2449|167|R|   Do not flush medications down the toilet or pour them into a||
2449|168|R|drain unless instructed to do so. Properly discard this product||
2449|169|R|when it is expired or no longer needed. Consult your pharmacist||
2449|170|R|or local waste disposal company.||
2449|171|B|||
2449|172|A|Information last revised November 2025.||
2449|173|A|Copyright(c) 2025 First Databank, Inc.||
2449|174|B|||
2450|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2450|002|Z|does NOT have all possible information about this product. This||
2450|003|Z|information does not assure that this product is safe, effective,||
2450|004|Z|or appropriate for you. This information is not individual||
2450|005|Z|medical advice and does not substitute for the advice of your||
2450|006|Z|health care professional. Always ask your health care||
2450|007|Z|professional for complete information about this product and your||
2450|008|Z|specific health needs.||
2450|009|B|||
2450|010|T|LUSPATERCEPT - INJECTION||
2450|011|F|(lus-PAT-er-sept)||
2450|012|B|||
2450|013|C|COMMON BRAND NAME(S): Reblozyl||
2450|014|B|||
2450|015|U|USES:  This medication is used to treat anemia caused by certain||
2450|016|U|blood and bone marrow disorders (such as beta thalassemia,||
2450|017|U|myelodysplastic syndromes). In these conditions, your body does||
2450|018|U|not make enough healthy red blood cells. This medication is||
2450|019|U|thought to work by increasing your body's production of healthy||
2450|020|U|red blood cells and hemoglobin. This effect may lessen your||
2450|021|U|symptoms caused by anemia and decrease your need for regular||
2450|022|U|blood transfusions.||
2450|023|B|||
2450|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2450|025|H|from your pharmacist before you start using luspatercept and each||
2450|026|H|time you get a refill. If you have any questions, ask your doctor||
2450|027|H|or pharmacist.||
2450|028|H|   This medication is given by injection under the skin by a||
2450|029|H|health care professional as directed by your doctor, usually once||
2450|030|H|every 3 weeks. The injection is given in the upper arm, thigh, or||
2450|031|H|abdomen. The dosage is based on your medical condition, weight,||
2450|032|H|and response to treatment.||
2450|033|H|   Use this medication regularly to get the most benefit from it.||
2450|034|H|To help you remember, mark your calendar with a reminder.||
2450|035|H|   Tell your doctor if your symptoms do not get better or if they||
2450|036|H|get worse.||
2450|037|B|||
2450|038|S|SIDE EFFECTS:  Tiredness, headache, muscle/joint pain, dizziness,||
2450|039|S|nausea, or diarrhea may occur. If any of these effects last or||
2450|040|S|get worse, tell your doctor or pharmacist promptly.||
2450|041|S|   Remember that this medication has been prescribed because your||
2450|042|S|doctor has judged that the benefit to you is greater than the||
2450|043|S|risk of side effects. Many people using this medication do not||
2450|044|S|have serious side effects.||
2450|045|S|   This medication may raise your blood pressure. Check your||
2450|046|S|blood pressure regularly and tell your doctor if the results are||
2450|047|S|high. Your doctor may control your blood pressure with||
2450|048|S|medication.||
2450|049|S|   This medication may rarely cause serious (sometimes fatal)||
2450|050|S|problems from blood clots (such as heart attack, stroke, blood||
2450|051|S|clots in the lungs or legs). You may be at increased risk for||
2450|052|S|blood clots if you have had your spleen removed, or have a||
2450|053|S|history of blood clots, or if you are immobile (such as on very||
2450|054|S|long plane flights or being bedridden). If you use||
2450|055|S|estrogen-containing products, these may also increase your risk.||
2450|056|S|Before using this medication, if you have any of these conditions||
2450|057|S|report them to your doctor or pharmacist. Get medical help right||
2450|058|S|away if any of these side effects occur: shortness of||
2450|059|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
2450|060|S|sweating, confusion, sudden dizziness/fainting,||
2450|061|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2450|062|S|trouble speaking, weakness on one side of the body, sudden vision||
2450|063|S|changes.||
2450|064|S|   Some people who have beta thalassemia and are treated with||
2450|065|S|this medication have rarely had a certain tissue problem||
2450|066|S|(extramedullary hematopoietic masses-EMH masses) develop. Your||
2450|067|S|risk for this problem may be higher if you have a past history of||
2450|068|S|EMH masses, or have had your spleen removed, or have an enlarged||
2450|069|S|spleen or liver, or have low hemoglobin levels. Careful||
2450|070|S|monitoring by your doctor may decrease your risk. Tell your||
2450|071|S|doctor right away if you develop symptoms such as: severe back||
2450|072|S|pain, numbness/weakness/loss of ability to control movement in||
2450|073|S|your feet, legs, hand, or arms, loss of bowel or bladder control.||
2450|074|S|   A very serious allergic reaction to this drug is rare.||
2450|075|S|However, get medical help right away if you notice any symptoms||
2450|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2450|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2450|078|S|breathing.||
2450|079|S|   This is not a complete list of possible side effects. If you||
2450|080|S|notice other effects not listed above, contact your doctor or||
2450|081|S|pharmacist.||
2450|082|S|   In the US -||
2450|083|S|   Call your doctor for medical advice about side effects. You||
2450|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2450|085|S|www.fda.gov/medwatch.||
2450|086|S|   In Canada - Call your doctor for medical advice about side||
2450|087|S|effects. You may report side effects to Health Canada at||
2450|088|S|1-866-234-2345.||
2450|089|B|||
2450|090|P|PRECAUTIONS:  See also Side Effects section.||
2450|091|P|   Before using luspatercept, tell your doctor or pharmacist if||
2450|092|P|you are allergic to it; or if you have any other allergies. This||
2450|093|P|product may contain inactive ingredients, which can cause||
2450|094|P|allergic reactions or other problems. Talk to your pharmacist for||
2450|095|P|more details.||
2450|096|P|   Before using this medication, tell your doctor or pharmacist||
2450|097|P|your medical history, especially of: high blood pressure, blood||
2450|098|P|clots, liver problems, spleen problems, a certain tissue problem||
2450|099|P|(extramedullary hematopoietic masses-EMH masses).||
2450|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2450|101|P|can make you more dizzy. Do not drive, use machinery, or do||
2450|102|P|anything that needs alertness until you can do it safely. Limit||
2450|103|P|alcoholic beverages. Talk to your doctor if you are using||
2450|104|P|marijuana (cannabis).||
2450|105|P|   Before having surgery, tell your doctor or dentist about all||
2450|106|P|the products you use (including prescription drugs,||
2450|107|P|nonprescription drugs, and herbal products).||
2450|108|P|   Tell your doctor if you are pregnant or plan to become||
2450|109|P|pregnant. You should not become pregnant while using||
2450|110|P|luspatercept. Luspatercept may harm an unborn baby. Your doctor||
2450|111|P|should order a pregnancy test before you start this medication.||
2450|112|P|Ask about reliable forms of birth control while using this||
2450|113|P|medication and for at least 3 months after the last dose. If you||
2450|114|P|become pregnant, talk to your doctor right away about the risks||
2450|115|P|and benefits of this medication.||
2450|116|P|   It is unknown if this medication passes into breast milk.||
2450|117|P|Because of the possible risk to the infant, breastfeeding is not||
2450|118|P|recommended while using this medication and for 3 months after||
2450|119|P|the last dose. Consult your doctor before breastfeeding.||
2450|120|B|||
2450|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2450|122|I|medications work or increase your risk for serious side effects.||
2450|123|I|This document does not contain all possible drug interactions.||
2450|124|I|Keep a list of all the products you use (including||
2450|125|I|prescription/nonprescription drugs and herbal products) and share||
2450|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
2450|127|I|the dosage of any medicines without your doctor's approval.||
2450|128|B|||
2450|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2450|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2450|131|O|poison control center right away. US residents can call||
2450|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2450|133|B|||
2450|134|N|NOTES:  Lab and/or medical tests (such as hemoglobin levels,||
2450|135|N|complete blood count, blood pressure) must be done while you are||
2450|136|N|using this medication. Keep all medical and lab appointments.||
2450|137|B|||
2450|138|D|MISSED DOSE:  It is important to get each dose of this medication||
2450|139|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2450|140|D|right away for a new dosing schedule.||
2450|141|B|||
2450|142|R|STORAGE:  Not applicable. This medication is given in a hospital||
2450|143|R|or clinic or doctor's office and will not be stored at home.||
2450|144|B|||
2450|145|A|Information last revised October 2024.||
2450|146|A|Copyright(c) 2025 First Databank, Inc.||
2450|147|B|||
2451|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2451|002|Z|does NOT have all possible information about this product. This||
2451|003|Z|information does not assure that this product is safe, effective,||
2451|004|Z|or appropriate for you. This information is not individual||
2451|005|Z|medical advice and does not substitute for the advice of your||
2451|006|Z|health care professional. Always ask your health care||
2451|007|Z|professional for complete information about this product and your||
2451|008|Z|specific health needs.||
2451|009|B|||
2451|010|T|FUTIBATINIB - ORAL||
2451|011|F|(FUE-ti-BA-ti-nib)||
2451|012|B|||
2451|013|C|COMMON BRAND NAME(S): Lytgobi||
2451|014|B|||
2451|015|U|USES:  This medication is used to treat a certain type of cancer||
2451|016|U|(bile duct cancer). Futibatinib works by slowing or stopping the||
2451|017|U|growth of cancer cells. It belongs to a class of drugs known as||
2451|018|U|kinase inhibitors.||
2451|019|B|||
2451|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2451|021|H|from your pharmacist before you start using futibatinib and each||
2451|022|H|time you get a refill. If you have any questions, ask your doctor||
2451|023|H|or pharmacist.||
2451|024|H|   Take this medication by mouth with or without food as directed||
2451|025|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2451|026|H|not crush, chew, split, or dissolve the tablets.||
2451|027|H|   The dosage is based on your medical condition and response to||
2451|028|H|treatment. If you have certain side effects, your doctor may||
2451|029|H|adjust your dose or stop treatment for some time.||
2451|030|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2451|031|H|using this medication unless your doctor or pharmacist says you||
2451|032|H|may do so safely. Grapefruit can increase the chance of side||
2451|033|H|effects with this medicine. Ask your doctor or pharmacist for||
2451|034|H|more details.||
2451|035|H|   If you vomit your dose of futibatinib, do not take another||
2451|036|H|dose. Take your next dose at your regular scheduled time. Do not||
2451|037|H|take two doses at the same time.||
2451|038|H|   Take this medication regularly to get the most benefit from||
2451|039|H|it. To help you remember, take it at the same time each day.||
2451|040|H|   Do not increase your dose or use this drug more often or for||
2451|041|H|longer than prescribed. Your condition will not improve any||
2451|042|H|faster, and your risk of serious side effects will increase.||
2451|043|H|   Since this drug can be absorbed through the skin and lungs and||
2451|044|H|may harm an unborn baby, women who are pregnant or who may become||
2451|045|H|pregnant should not handle this medication or breathe the dust||
2451|046|H|from the tablets.||
2451|047|B|||
2451|048|S|SIDE EFFECTS:  Dry eyes, weight loss, dry mouth, changes in||
2451|049|S|taste, nausea, vomiting, diarrhea, constipation,||
2451|050|S|stomach/abdominal pain, tiredness/weakness, or dry skin may||
2451|051|S|occur. If any of these effects last or get worse, tell your||
2451|052|S|doctor or pharmacist promptly.||
2451|053|S|   Pain or sores in the mouth and throat may occur. Brush your||
2451|054|S|teeth carefully/gently, avoid using mouthwash that contains||
2451|055|S|alcohol, and rinse your mouth often with cool water mixed with||
2451|056|S|baking soda or salt. It may also be best to eat soft, moist||
2451|057|S|foods.||
2451|058|S|   To relieve or prevent dry eyes, use lubricating eye drops or||
2451|059|S|gel (such as artificial tears).||
2451|060|S|   Temporary hair loss may occur. Normal hair growth should||
2451|061|S|return after treatment has ended.||
2451|062|S|   People using this medication may have serious side effects.||
2451|063|S|However, you have been prescribed this drug because your doctor||
2451|064|S|has judged that the benefit to you is greater than the risk of||
2451|065|S|side effects. Careful monitoring by your doctor may decrease your||
2451|066|S|risk.||
2451|067|S|   Tell your doctor right away if you have any serious side||
2451|068|S|effects, including: vision changes (such as blurred vision,||
2451|069|S|seeing floaters/flashes of light), signs of high phosphate levels||
2451|070|S|(such as muscle cramps, mental/mood changes, numbness/tingling||
2451|071|S|around the mouth), nail problems (such as loosening of nail).||
2451|072|S|   A very serious allergic reaction to this drug is rare.||
2451|073|S|However, get medical help right away if you notice any symptoms||
2451|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2451|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2451|076|S|breathing.||
2451|077|S|   This is not a complete list of possible side effects. If you||
2451|078|S|notice other effects not listed above, contact your doctor or||
2451|079|S|pharmacist.||
2451|080|S|   In the US -||
2451|081|S|   Call your doctor for medical advice about side effects. You||
2451|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2451|083|S|www.fda.gov/medwatch.||
2451|084|S|   In Canada - Call your doctor for medical advice about side||
2451|085|S|effects. You may report side effects to Health Canada at||
2451|086|S|1-866-234-2345.||
2451|087|B|||
2451|088|P|PRECAUTIONS:  Before taking futibatinib, tell your doctor or||
2451|089|P|pharmacist if you are allergic to it; or if you have any other||
2451|090|P|allergies. This product may contain inactive ingredients, which||
2451|091|P|can cause allergic reactions or other problems. Talk to your||
2451|092|P|pharmacist for more details.||
2451|093|P|   Before using this medication, tell your doctor or pharmacist||
2451|094|P|your medical history, especially of: eye disorders, high level of||
2451|095|P|phosphate in the blood, liver disease.||
2451|096|P|   Before having surgery, tell your doctor or dentist about all||
2451|097|P|the products you use (including prescription drugs,||
2451|098|P|nonprescription drugs, and herbal products).||
2451|099|P|   Since this drug can be absorbed through the skin and lungs and||
2451|100|P|may harm an unborn baby, women who are pregnant or who may become||
2451|101|P|pregnant should not handle this medication or breathe the dust||
2451|102|P|from the tablets.||
2451|103|P|   Tell your doctor if you are pregnant or plan to become||
2451|104|P|pregnant. You should not become pregnant while using futibatinib.||
2451|105|P|Futibatinib may harm an unborn baby. Your doctor should order a||
2451|106|P|pregnancy test before you start this medication. Women and men||
2451|107|P|using this medication should ask about reliable forms of birth||
2451|108|P|control during treatment and for 1 week after the last dose. If||
2451|109|P|you or your partner becomes pregnant, talk to your doctor right||
2451|110|P|away about the risks and benefits of this medication.||
2451|111|P|   It is unknown if this drug passes into breast milk. Because of||
2451|112|P|the possible risk to the infant, breastfeeding is not recommended||
2451|113|P|while using this drug and for 1 week after the last dose. Consult||
2451|114|P|your doctor before breastfeeding.||
2451|115|B|||
2451|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2451|117|I|medications work or increase your risk for serious side effects.||
2451|118|I|This document does not contain all possible drug interactions.||
2451|119|I|Keep a list of all the products you use (including||
2451|120|I|prescription/nonprescription drugs and herbal products) and share||
2451|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
2451|122|I|the dosage of any medicines without your doctor's approval.||
2451|123|I|   Other medications can affect the removal of futibatinib from||
2451|124|I|your body, which may affect how futibatinib works. Examples||
2451|125|I|include apalutamide, carbamazepine, phenytoin, rifampin,||
2451|126|I|rifapentine, St. John's wort, among others.||
2451|127|B|||
2451|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2451|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2451|130|O|poison control center right away. US residents can call||
2451|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2451|132|B|||
2451|133|N|NOTES:  Do not share this medication with others.||
2451|134|N|   Lab and/or medical tests (such as eye exam, phosphate levels)||
2451|135|N|should be done before you start taking this medication and while||
2451|136|N|you are taking it. Keep all medical and lab appointments.||
2451|137|B|||
2451|138|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2451|139|D|remember. If it is more than 12 hours after the missed dose, skip||
2451|140|D|the missed dose. Take your next dose at the regular time. Do not||
2451|141|D|double the dose to catch up.||
2451|142|B|||
2451|143|R|STORAGE:  Store at room temperature away from light and moisture.||
2451|144|R|Do not store in the bathroom. Keep all medications away from||
2451|145|R|children and pets.||
2451|146|R|   Do not flush medications down the toilet or pour them into a||
2451|147|R|drain unless instructed to do so. Properly discard this product||
2451|148|R|when it is expired or no longer needed. Consult your pharmacist||
2451|149|R|or local waste disposal company.||
2451|150|B|||
2451|151|A|Information last revised May 2024.||
2451|152|A|Copyright(c) 2025 First Databank, Inc.||
2451|153|B|||
2452|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2452|002|Z|does NOT have all possible information about this product. This||
2452|003|Z|information does not assure that this product is safe, effective,||
2452|004|Z|or appropriate for you. This information is not individual||
2452|005|Z|medical advice and does not substitute for the advice of your||
2452|006|Z|health care professional. Always ask your health care||
2452|007|Z|professional for complete information about this product and your||
2452|008|Z|specific health needs.||
2452|009|B|||
2452|010|T|TREMELIMUMAB - INJECTION||
2452|011|F|(TRE-me-LIM-ue-mab)||
2452|012|B|||
2452|013|C|COMMON BRAND NAME(S):  Imjudo||
2452|014|B|||
2452|015|U|USES:  Tremelimumab is used to treat certain cancers (such as||
2452|016|U|liver, lung). It works by helping your immune system fight the||
2452|017|U|cancer. This medication belongs to a class of drugs known as||
2452|018|U|monoclonal antibodies.||
2452|019|B|||
2452|020|H|HOW TO USE:  Read the Medication Guide provided by your||
2452|021|H|pharmacist before you start receiving tremelimumab and each time||
2452|022|H|you get a treatment. If you have any questions, ask your doctor||
2452|023|H|or pharmacist.||
2452|024|H|   This medication is given by a health care professional as||
2452|025|H|directed by your doctor. It is injected slowly into a vein over||
2452|026|H|60 minutes. The dosage and treatment schedule are based on your||
2452|027|H|medical condition, weight, and response to treatment.||
2452|028|H|   Infusion reactions may happen during the infusion of this||
2452|029|H|drug. Tell your doctor right away if you have any symptoms of||
2452|030|H|infusion reactions such as chills, flushing, itching, dizziness,||
2452|031|H|or shortness of breath. Your doctor may give you other||
2452|032|H|medications to help with these side effects or may stop your||
2452|033|H|treatment for some time||
2452|034|H|   To get the most benefit, do not miss any doses. To help you||
2452|035|H|remember, mark your calendar with a reminder.||
2452|036|B|||
2452|037|S|SIDE EFFECTS:  See also How to Use section.||
2452|038|S|   Tiredness, loss of appetite, nausea, muscle/bone pain, or||
2452|039|S|trouble sleeping may occur. If any of these effects last or get||
2452|040|S|worse, tell your doctor or pharmacist promptly.||
2452|041|S|   People using this medication may have serious side effects.||
2452|042|S|However, you have been prescribed this drug because your doctor||
2452|043|S|has judged that the benefit to you is greater than the risk of||
2452|044|S|side effects. Careful monitoring by your doctor may decrease your||
2452|045|S|risk.||
2452|046|S|   Tell your doctor right away if you have any serious side||
2452|047|S|effects, including: headache that is severe or doesn't go away,||
2452|048|S|signs of new/worsening liver disease (such as nausea/vomiting||
2452|049|S|that doesn't stop, stomach/abdominal pain, yellowing eyes/skin,||
2452|050|S|dark urine), new/worsening cough, diarrhea, blood/mucus in your||
2452|051|S|stool, eye/vision problems (such as blurred vision, vision||
2452|052|S|changes, eye pain), stiff/painful neck, unusual weight gain/loss,||
2452|053|S|mental/mood changes (such as confusion), cold or heat||
2452|054|S|intolerance, fast/slow/pounding/irregular heartbeat, increased||
2452|055|S|thirst/urination, muscle weakness, numbness/tingling of||
2452|056|S|arms/legs, easy bruising/bleeding, burning/painful/urgent||
2452|057|S|urination, signs of kidney problems (such as pink/bloody urine,||
2452|058|S|change in the amount of urine).||
2452|059|S|   Get medical help right away if you have any very serious side||
2452|060|S|effects, including: chest pain, shortness of breath.||
2452|061|S|   A very serious allergic reaction to this drug is rare.||
2452|062|S|However, get medical help right away if you notice any symptoms||
2452|063|S|of a serious allergic reaction, including: fever, swollen lymph||
2452|064|S|nodes, rash, itching/swelling (especially of the||
2452|065|S|face/tongue/throat), severe dizziness, trouble breathing.||
2452|066|S|   This is not a complete list of possible side effects. If you||
2452|067|S|notice other effects not listed above, contact your doctor or||
2452|068|S|pharmacist.||
2452|069|S|   In the US -||
2452|070|S|   Call your doctor for medical advice about side effects. You||
2452|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2452|072|S|www.fda.gov/medwatch.||
2452|073|S|   In Canada - Call your doctor for medical advice about side||
2452|074|S|effects. You may report side effects to Health Canada at||
2452|075|S|1-866-234-2345.||
2452|076|B|||
2452|077|P|PRECAUTIONS:  Before using tremelimumab, tell your doctor or||
2452|078|P|pharmacist if you are allergic to it; or if you have any other||
2452|079|P|allergies. This product may contain inactive ingredients, which||
2452|080|P|can cause allergic reactions or other problems. Talk to your||
2452|081|P|pharmacist for more details.||
2452|082|P|   Before using this medication, tell your doctor or pharmacist||
2452|083|P|your medical history.||
2452|084|P|   Before having surgery, tell your doctor or dentist about all||
2452|085|P|the products you use (including prescription drugs,||
2452|086|P|nonprescription drugs, and herbal products).||
2452|087|P|   Tell your doctor if you are pregnant or plan to become||
2452|088|P|pregnant. You should not become pregnant while using||
2452|089|P|tremelimumab. Tremelimumab may harm an unborn baby. Your doctor||
2452|090|P|should order a pregnancy test before you start this medication.||
2452|091|P|Ask about reliable forms of birth control while using this||
2452|092|P|medication and for at least 3 months after the last dose. If you||
2452|093|P|become pregnant, talk to your doctor right away about the risks||
2452|094|P|and benefits of this medication.||
2452|095|P|   It is unknown if this drug passes into breast milk. Because of||
2452|096|P|the possible risk to the infant, breastfeeding is not recommended||
2452|097|P|while using this drug and for at least 3 months after the last||
2452|098|P|dose. Consult your doctor before breastfeeding.||
2452|099|B|||
2452|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2452|101|I|medications work or increase your risk for serious side effects.||
2452|102|I|This document does not contain all possible drug interactions.||
2452|103|I|Keep a list of all the products you use (including||
2452|104|I|prescription/nonprescription drugs and herbal products) and share||
2452|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
2452|106|I|the dosage of any medicines without your doctor's approval.||
2452|107|B|||
2452|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2452|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2452|110|O|poison control center right away. US residents can call||
2452|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2452|112|B|||
2452|113|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
2452|114|N|function) should be done while you are using this medication.||
2452|115|N|Keep all medical and lab appointments.||
2452|116|B|||
2452|117|D|MISSED DOSE:  It is important to get each dose of this medication||
2452|118|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2452|119|D|right away for a new dosing schedule.||
2452|120|B|||
2452|121|R|STORAGE:  Not applicable. This medication is given in a hospital||
2452|122|R|or clinic and will not be stored at home.||
2452|123|B|||
2452|124|A|Information last revised October 2024.||
2452|125|A|Copyright(c) 2025 First Databank, Inc.||
2452|126|B|||
2453|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2453|002|Z|does NOT have all possible information about this product. This||
2453|003|Z|information does not assure that this product is safe, effective,||
2453|004|Z|or appropriate for you. This information is not individual||
2453|005|Z|medical advice and does not substitute for the advice of your||
2453|006|Z|health care professional. Always ask your health care||
2453|007|Z|professional for complete information about this product and your||
2453|008|Z|specific health needs.||
2453|009|B|||
2453|010|T|DEXTROAMPHETAMINE - TRANSDERMAL||
2453|011|F|(DEX-troe-am-FET-a-meen)||
2453|012|B|||
2453|013|C|COMMON BRAND NAME(S): Xelstrym||
2453|014|B|||
2453|015|W|WARNING:  Misuse or abuse of dextroamphetamine can result in||
2453|016|W|serious (possibly fatal) heart and blood pressure problems.||
2453|017|W|   This medication can be habit-forming and should be used||
2453|018|W|cautiously by people who have mental/mood disorders or a||
2453|019|W|substance use disorder (such as overuse of or addiction to||
2453|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
2453|021|W|you have a personal or family history of a substance use||
2453|022|W|disorder. Do not increase your dose, use it more often, or use it||
2453|023|W|for a longer time or in a different way than prescribed. Doing so||
2453|024|W|may result in a decrease in the effect of this drug, drug||
2453|025|W|dependence, or abnormal thoughts/behavior.||
2453|026|W|   Your doctor may monitor you for a while after the medication||
2453|027|W|is stopped, especially if you have used this drug for a long time||
2453|028|W|or in high doses. (See also How to Use section.)||
2453|029|B|||
2453|030|U|USES:  This medication is used to treat attention deficit||
2453|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
2453|032|U|of certain natural substances in the brain. Dextroamphetamine||
2453|033|U|belongs to a class of drugs known as stimulants. It can help||
2453|034|U|increase your ability to pay attention, stay focused on an||
2453|035|U|activity, and control behavior problems. It may also help you to||
2453|036|U|organize your tasks and improve listening skills.||
2453|037|B|||
2453|038|H|HOW TO USE:  Read the Medication Guide provided by your||
2453|039|H|pharmacist before you start using dextroamphetamine and each time||
2453|040|H|you get a refill. Read and follow all directions in the||
2453|041|H|Instructions for Use. Learn how to properly use, store, and||
2453|042|H|discard the patches. If you have any questions, ask your doctor||
2453|043|H|or pharmacist.||
2453|044|H|   Apply this medication to the skin as directed by your doctor,||
2453|045|H|usually once daily in the morning, 2 hours before you need the||
2453|046|H|effects of this drug. Then remove the patch as directed by your||
2453|047|H|doctor, usually 9 hours later. Applying this medication late in||
2453|048|H|the day may cause trouble sleeping (insomnia). If you apply this||
2453|049|H|patch in the early morning and still have trouble sleeping, your||
2453|050|H|doctor may direct you to remove the patch within less than 9||
2453|051|H|hours. Carefully follow your doctor's instructions.||
2453|052|H|   This medication should be applied to a clean, dry, hairless or||
2453|053|H|nearly hairless area of skin on the upper chest, upper arm, upper||
2453|054|H|back, hip, or sides of the waist (flanks). Before applying the||
2453|055|H|patch, gently wash, rinse, and dry the application area. Do not||
2453|056|H|apply to cut, scraped, burned, or irritated skin. Remove the||
2453|057|H|patch from the pouch and apply right away as directed. Do not use||
2453|058|H|a cut or damaged patch. When using a new patch the next day,||
2453|059|H|apply to a different area of skin to avoid irritation. Do not||
2453|060|H|apply a heating pad or other heat to the patch area since this||
2453|061|H|may increase the risk of side effects. Bathing, swimming, or||
2453|062|H|showering may affect how well the patch stays on the skin. If the||
2453|063|H|patch does not stick properly or falls off, replace with a new||
2453|064|H|patch at another site. Remove the new patch at your usual time,||
2453|065|H|usually 9 hours after applying the first patch.||
2453|066|H|   After removing the patch, fold it in half with the sticky||
2453|067|H|sides together and throw it away as directed. Do not touch the||
2453|068|H|sticky side with your fingers. Wash your hands after applying or||
2453|069|H|removing the patch.||
2453|070|H|   Use this medication regularly to get the most benefit from it.||
2453|071|H|To help you remember, use it at the same time each day.||
2453|072|H|   The dosage is based on your medical condition and response to||
2453|073|H|treatment. Your doctor may adjust your dose to find the dose that||
2453|074|H|is best for you. During treatment, your doctor may sometimes||
2453|075|H|recommend stopping the medication to see if it is still needed.||
2453|076|H|Carefully follow your doctor's instructions.||
2453|077|H|   If you suddenly stop using this medication, you may have||
2453|078|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
2453|079|H|mental/mood changes such as depression). To help prevent||
2453|080|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
2453|081|H|more likely if you have used dextroamphetamine for a long time or||
2453|082|H|in high doses. Tell your doctor or pharmacist right away if you||
2453|083|H|have withdrawal.||
2453|084|H|   When this medication is used for a long time, it may not work||
2453|085|H|as well. Talk with your doctor if this medication stops working||
2453|086|H|well.||
2453|087|H|   Though it helps many people, this medication may sometimes||
2453|088|H|cause addiction. This risk may be higher if you have a substance||
2453|089|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2453|090|H|Use this medication exactly as prescribed to lower the risk of||
2453|091|H|addiction. Ask your doctor or pharmacist for more details.||
2453|092|H|   Tell your doctor if your condition does not get better or if||
2453|093|H|it gets worse.||
2453|094|B|||
2453|095|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
2453|096|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
2453|097|S|Mild irritation, pain, itching, or redness at the application||
2453|098|S|site may also occur. If any of these effects last or get worse,||
2453|099|S|tell your doctor or pharmacist promptly.||
2453|100|S|   Remember that this medication has been prescribed because your||
2453|101|S|doctor has judged that the benefit to you is greater than the||
2453|102|S|risk of side effects. Many people using this medication do not||
2453|103|S|have serious side effects.||
2453|104|S|   This medication may raise your blood pressure. Check your||
2453|105|S|blood pressure regularly and tell your doctor if the results are||
2453|106|S|high.||
2453|107|S|   Tell your doctor right away if you have any serious side||
2453|108|S|effects, including: signs of blood flow problems in the fingers||
2453|109|S|or toes (such as coldness, numbness, pain, or skin color||
2453|110|S|changes), unusual wounds on the fingers or toes,||
2453|111|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
2453|112|S|(such as agitation, aggression, mood swings, depression, abnormal||
2453|113|S|thoughts/behavior, thoughts of suicide), uncontrolled muscle||
2453|114|S|movements (such as twitching, shaking), sudden outbursts of||
2453|115|S|words/sounds, change in sexual ability/interest,||
2453|116|S|frequent/prolonged erections (in males).||
2453|117|S|   Get medical help right away if you have any very serious side||
2453|118|S|effects, including: fainting, symptoms of a heart attack (such as||
2453|119|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
2453|120|S|symptoms of a stroke (such as weakness on one side of the body,||
2453|121|S|trouble speaking, sudden vision changes, confusion).||
2453|122|S|   This medication may increase serotonin and rarely cause a very||
2453|123|S|serious condition called serotonin syndrome/toxicity. The risk||
2453|124|S|increases if you are also taking other drugs that increase||
2453|125|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2453|126|S|take (see Drug Interactions section). Get medical help right away||
2453|127|S|if you develop some of the following symptoms: fast heartbeat,||
2453|128|S|hallucinations, loss of coordination, severe dizziness, severe||
2453|129|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2453|130|S|unusual agitation/restlessness.||
2453|131|S|   A very serious allergic reaction to this drug is rare.||
2453|132|S|However, get medical help right away if you notice any symptoms||
2453|133|S|of a serious allergic reaction, including: rash, itching/swelling||
2453|134|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2453|135|S|breathing.||
2453|136|S|   This is not a complete list of possible side effects. If you||
2453|137|S|notice other effects not listed above, contact your doctor or||
2453|138|S|pharmacist.||
2453|139|S|   In the US -||
2453|140|S|   Call your doctor for medical advice about side effects. You||
2453|141|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2453|142|S|www.fda.gov/medwatch.||
2453|143|S|   In Canada - Call your doctor for medical advice about side||
2453|144|S|effects. You may report side effects to Health Canada at||
2453|145|S|1-866-234-2345.||
2453|146|B|||
2453|147|P|PRECAUTIONS:  See also Warning section.||
2453|148|P|   Before using dextroamphetamine, tell your doctor or pharmacist||
2453|149|P|if you are allergic to it; or to other sympathomimetic drugs||
2453|150|P|(such as amphetamine or lisdexamfetamine); or if you have any||
2453|151|P|other allergies. This product may contain inactive ingredients,||
2453|152|P|which can cause allergic reactions or other problems. Talk to||
2453|153|P|your pharmacist for more details.||
2453|154|P|   Before using this medication, tell your doctor or pharmacist||
2453|155|P|your medical history, especially of: high blood pressure, blood||
2453|156|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
2453|157|P|problems (such as irregular heartbeat, heart failure, previous||
2453|158|P|heart attack, problems with heart structure), family history of||
2453|159|P|heart problems (such as sudden cardiac death, irregular||
2453|160|P|heartbeat), mental/mood conditions (such as anxiety, agitation),||
2453|161|P|personal/family history of mental/mood disorders (such as bipolar||
2453|162|P|disorder, depression, psychosis, suicidal thoughts),||
2453|163|P|personal/family history of uncontrolled muscle movements (motor||
2453|164|P|tics, Tourette's syndrome), overactive thyroid (hyperthyroidism),||
2453|165|P|stroke, seizures.||
2453|166|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2453|167|P|can make you more dizzy. Do not drive, use machinery, or do||
2453|168|P|anything that needs alertness until you can do it safely. Limit||
2453|169|P|alcoholic beverages. Talk to your doctor if you are using||
2453|170|P|marijuana (cannabis).||
2453|171|P|   If you are going to have an MRI test, tell testing personnel||
2453|172|P|that you are using this patch. Some patches may contain metals||
2453|173|P|that can cause serious burns during an MRI. Ask your doctor||
2453|174|P|whether you will need to remove your patch before the test and||
2453|175|P|apply a new patch afterward, and how to do so properly.||
2453|176|P|   Before having surgery, tell your doctor or dentist about all||
2453|177|P|the products you use (including prescription drugs,||
2453|178|P|nonprescription drugs, and herbal products).||
2453|179|P|   Children (especially those younger than 6) may be more||
2453|180|P|sensitive to the side effects of this drug, especially weight||
2453|181|P|loss. If used for a long time, this drug may affect a child's||
2453|182|P|growth rate, weight, and final adult height. To reduce the risk,||
2453|183|P|the doctor may recommend temporarily stopping the medication from||
2453|184|P|time to time. Monitor the child's weight and height. Consult your||
2453|185|P|doctor or pharmacist for more details.||
2453|186|P|   Older adults may be more sensitive to the side effects of this||
2453|187|P|drug, especially chest pain, trouble sleeping, or weight loss.||
2453|188|P|   During pregnancy, this medication should be used only when||
2453|189|P|clearly needed. Discuss the risks and benefits with your doctor.||
2453|190|P|Infants born to mothers who are dependent on this medication may||
2453|191|P|be born too soon (premature) and have low birth weight. They may||
2453|192|P|also have withdrawal symptoms. Tell your doctor right away if you||
2453|193|P|notice possible mood changes, agitation, or unusual tiredness in||
2453|194|P|your newborn.||
2453|195|P|   This medication passes into breast milk and may have||
2453|196|P|undesirable effects on a nursing infant. Breastfeeding is not||
2453|197|P|recommended while using this medication. Consult your doctor||
2453|198|P|before breastfeeding.||
2453|199|B|||
2453|200|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2453|201|I|medications work or increase your risk for serious side effects.||
2453|202|I|This document does not contain all possible drug interactions.||
2453|203|I|Keep a list of all the products you use (including||
2453|204|I|prescription/nonprescription drugs and herbal products) and share||
2453|205|I|it with your doctor and pharmacist. Do not start, stop, or change||
2453|206|I|the dosage of any medicines without your doctor's approval.||
2453|207|I|   Taking MAO inhibitors with this medication may cause a serious||
2453|208|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2453|209|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2453|210|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2453|211|I|selegiline, tranylcypromine) during treatment with this||
2453|212|I|medication. Most MAO inhibitors should also not be taken for two||
2453|213|I|weeks before treatment with this medication. Ask your doctor when||
2453|214|I|to start or stop taking this medication.||
2453|215|I|   Some products have ingredients that could raise your heart||
2453|216|I|rate or blood pressure. Tell your pharmacist what products you||
2453|217|I|are using, and ask how to use them safely (especially||
2453|218|I|cough-and-cold products or diet aids).||
2453|219|I|   The risk of serotonin syndrome/toxicity increases if you are||
2453|220|I|also taking other drugs that increase serotonin. Examples include||
2453|221|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
2453|222|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2453|223|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2453|224|I|serotonin syndrome/toxicity may be more likely when you start or||
2453|225|I|increase the dose of these drugs.||
2453|226|I|   Dextroamphetamine is very similar to amphetamine or||
2453|227|I|lisdexamfetamine. Do not use medications containing amphetamine||
2453|228|I|or lisdexamfetamine while using dextroamphetamine.||
2453|229|I|   This medication may interfere with certain lab/medical tests||
2453|230|I|(such as blood and urine steroid levels, brain scan for||
2453|231|I|Parkinson's disease), possibly causing false test results. Make||
2453|232|I|sure lab personnel and all your doctors know you use this drug.||
2453|233|B|||
2453|234|O|OVERDOSE:  This medication patch may be harmful if chewed or||
2453|235|O|swallowed. If someone has overdosed, remove the patch if||
2453|236|O|possible. For serious symptoms such as passing out or trouble||
2453|237|O|breathing, call 911. Otherwise, call a poison control center||
2453|238|O|right away. US residents can call 1-800-222-1222. Canada||
2453|239|O|residents can call 1-844-764-7669. Symptoms of overdose may||
2453|240|O|include: headache that is severe or doesn't go away, severe||
2453|241|O|mental/mood changes, seizures, severe restlessness, fast||
2453|242|O|breathing.||
2453|243|B|||
2453|244|N|NOTES:  Do not share this medication with others. Sharing it is||
2453|245|N|against the law.||
2453|246|N|   Lab and/or medical tests (such as blood pressure, pulse,||
2453|247|N|complete blood count, growth monitoring in children) may be done||
2453|248|N|while you are using this medication. Keep all medical and lab||
2453|249|N|appointments.||
2453|250|N|   If switching from another form of dextroamphetamine to this||
2453|251|N|patch, carefully follow your doctor's instructions.||
2453|252|B|||
2453|253|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2453|254|D|If it is near bedtime or near the time of the next dose, skip the||
2453|255|D|missed dose. Use your next dose at the regular time. Do not||
2453|256|D|double the dose to catch up.||
2453|257|B|||
2453|258|R|STORAGE:  Store at room temperature away from light and moisture.||
2453|259|R|Keep the patch in the sealed pouch until ready to use. Do not||
2453|260|R|refrigerate or freeze. Do not store in the bathroom. Keep all||
2453|261|R|medications away from children and pets.||
2453|262|R|   Do not flush medications down the toilet or pour them into a||
2453|263|R|drain unless instructed to do so. Properly discard this product||
2453|264|R|when it is expired or no longer needed (see also How to Use||
2453|265|R|section). For more details, read the Instructions for Use, or||
2453|266|R|consult your pharmacist or local waste disposal company.||
2453|267|B|||
2453|268|A|Information last revised July 2025.||
2453|269|A|Copyright(c) 2025 First Databank, Inc.||
2453|270|B|||
2454|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2454|002|Z|does NOT have all possible information about this product. This||
2454|003|Z|information does not assure that this product is safe, effective,||
2454|004|Z|or appropriate for you. This information is not individual||
2454|005|Z|medical advice and does not substitute for the advice of your||
2454|006|Z|health care professional. Always ask your health care||
2454|007|Z|professional for complete information about this product and your||
2454|008|Z|specific health needs.||
2454|009|B|||
2454|010|T|POSACONAZOLE DELAYED-RELEASE PACKET - ORAL||
2454|011|F|(POE-sa-KON-a-zole)||
2454|012|B|||
2454|013|C|COMMON BRAND NAME(S): Noxafil PowderMix||
2454|014|B|||
2454|015|U|USES:  Posaconazole is used to prevent certain fungal infections||
2454|016|U|in children who have severely weakened immune systems (such as||
2454|017|U|patients who have had chemotherapy). It belongs to a class of||
2454|018|U|drugs known as azole antifungals. It works by stopping the growth||
2454|019|U|of fungi.||
2454|020|U|   This form of posaconazole is not recommended for use by||
2454|021|U|children who weigh more than 88 pounds (40 kilograms) since this||
2454|022|U|dosage form will not provide the right dose.||
2454|023|B|||
2454|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
2454|025|H|Instructions for Use if available from your pharmacist before you||
2454|026|H|start taking posaconazole and each time you get a refill. If you||
2454|027|H|have any questions, ask your doctor or pharmacist.||
2454|028|H|   Take this medication by mouth with food as directed by your||
2454|029|H|doctor, usually twice daily for the first day, and then once||
2454|030|H|daily after that. Do not take this medication at the same time||
2454|031|H|with alcohol or with medications that contain alcohol. Doing so||
2454|032|H|can release all of the drug at once, increasing the risk of side||
2454|033|H|effects.||
2454|034|H|   Follow instructions on how to prepare and mix the suspension.||
2454|035|H|Do not open the powder packet until you are ready to prepare the||
2454|036|H|medication. Only use the mixing liquid provided in the kit to mix||
2454|037|H|the powder. Do not use any other liquid to mix. Shake the||
2454|038|H|medication well before using. The suspension should look cloudy||
2454|039|H|and free of clumps. Carefully measure the dose using the provided||
2454|040|H|measuring syringe. Do not use a household spoon because you may||
2454|041|H|not get the correct dose. After mixing, the medication should be||
2454|042|H|used within 1 hour. Discard any unused suspension.||
2454|043|H|   The dosage and length of treatment are based on your medical||
2454|044|H|condition and weight.||
2454|045|H|   For the best effect, take this antifungal at evenly spaced||
2454|046|H|times. To help you remember, take this medication at the same||
2454|047|H|time every day.||
2454|048|H|   Continue to take this medication until the full prescribed||
2454|049|H|amount is finished. Stopping the medication too early may result||
2454|050|H|in the medication not working well.||
2454|051|H|   This form of posaconazole may deliver different amounts of||
2454|052|H|medication than the tablet and regular-release suspension forms.||
2454|053|H|Do not switch between the different forms of this medication||
2454|054|H|without your doctor's permission and directions.||
2454|055|H|   Tell your doctor if you have severe diarrhea or vomiting.||
2454|056|H|Posaconazole may not work as well. If you are giving this||
2454|057|H|medication to a small child, tell the doctor if the child is||
2454|058|H|unable to take the full dose or is spitting out the medication.||
2454|059|B|||
2454|060|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, mouth sores, headache,||
2454|061|S|abdominal pain, dizziness, or stomach upset may occur. If any of||
2454|062|S|these effects last or get worse, tell your doctor or pharmacist||
2454|063|S|promptly.||
2454|064|S|   Remember that this medication has been prescribed because your||
2454|065|S|doctor has judged that the benefit to you is greater than the||
2454|066|S|risk of side effects. Many people using this medication do not||
2454|067|S|have serious side effects.||
2454|068|S|   This medication may raise your blood pressure. Check your||
2454|069|S|blood pressure regularly and tell your doctor if the results are||
2454|070|S|high.||
2454|071|S|   Tell your doctor right away if you have any serious side||
2454|072|S|effects, including: swelling hands/ankles/feet, signs of||
2454|073|S|infection (such as sore throat that doesn't go away, fever,||
2454|074|S|chills), unusual tiredness, weakness, muscle cramps, mental/mood||
2454|075|S|changes, easy bruising/bleeding, vaginal bleeding, shortness of||
2454|076|S|breath, increased thirst/urination.||
2454|077|S|   Get medical help right away if you have any very serious side||
2454|078|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2454|079|S|fainting.||
2454|080|S|   Posaconazole has rarely caused very serious (possibly fatal)||
2454|081|S|liver disease. Tell your doctor right away if you develop||
2454|082|S|symptoms of liver disease, such as: nausea/vomiting that doesn't||
2454|083|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
2454|084|S|eyes/skin, dark urine.||
2454|085|S|   A very serious allergic reaction to this drug is rare.||
2454|086|S|However, get medical help right away if you notice any symptoms||
2454|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2454|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2454|089|S|breathing.||
2454|090|S|   Posaconazole can commonly cause a mild rash that is usually||
2454|091|S|not serious. However, you may not be able to tell it apart from a||
2454|092|S|rare rash that could be a sign of a severe allergic reaction. Get||
2454|093|S|medical help right away if you develop any rash.||
2454|094|S|   This is not a complete list of possible side effects. If you||
2454|095|S|notice other effects not listed above, contact your doctor or||
2454|096|S|pharmacist.||
2454|097|S|   In the US -||
2454|098|S|   Call your doctor for medical advice about side effects. You||
2454|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2454|100|S|www.fda.gov/medwatch.||
2454|101|S|   In Canada - Call your doctor for medical advice about side||
2454|102|S|effects. You may report side effects to Health Canada at||
2454|103|S|1-866-234-2345.||
2454|104|B|||
2454|105|P|PRECAUTIONS:  Before taking posaconazole, tell your doctor or||
2454|106|P|pharmacist if you are allergic to it; or to other azole||
2454|107|P|antifungals (such as ketoconazole); or if you have any other||
2454|108|P|allergies. This product may contain inactive ingredients, which||
2454|109|P|can cause allergic reactions or other problems. Talk to your||
2454|110|P|pharmacist for more details.||
2454|111|P|   Before using this medication, tell your doctor or pharmacist||
2454|112|P|your medical history, especially of: liver disease, kidney||
2454|113|P|disease, a certain genetic enzyme problem (hereditary fructose||
2454|114|P|intolerance).||
2454|115|P|   Posaconazole may cause a condition that affects the heart||
2454|116|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2454|117|P|serious (rarely fatal) fast/irregular heartbeat and other||
2454|118|P|symptoms (such as severe dizziness, fainting) that need medical||
2454|119|P|attention right away.||
2454|120|P|   The risk of QT prolongation may be increased if you have||
2454|121|P|certain medical conditions or are taking other drugs that may||
2454|122|P|cause QT prolongation. Before using posaconazole, tell your||
2454|123|P|doctor or pharmacist of all the drugs you take and if you have||
2454|124|P|any of the following conditions: certain heart problems (heart||
2454|125|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2454|126|P|history of certain heart problems (QT prolongation in the EKG,||
2454|127|P|sudden cardiac death).||
2454|128|P|   Low levels of potassium or magnesium in the blood may also||
2454|129|P|increase your risk of QT prolongation. This risk may increase if||
2454|130|P|you use certain drugs (such as diuretics/"water pills") or if you||
2454|131|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2454|132|P|Talk to your doctor about using posaconazole safely.||
2454|133|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2454|134|P|can make you more dizzy. Do not drive, use machinery, or do||
2454|135|P|anything that needs alertness until you can do it safely. Avoid||
2454|136|P|alcoholic beverages. Talk to your doctor if you are using||
2454|137|P|marijuana (cannabis). Alcohol may also increase the risk of||
2454|138|P|serious liver problems.||
2454|139|P|   Before having surgery, tell your doctor or dentist about all||
2454|140|P|the products you use (including prescription drugs,||
2454|141|P|nonprescription drugs, and herbal products).||
2454|142|P|   Older adults may be more sensitive to the side effects of this||
2454|143|P|drug, especially QT prolongation (see above).||
2454|144|P|   During pregnancy, this medication should be used only when||
2454|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
2454|146|P|   It is unknown if this drug passes into breast milk. Consult||
2454|147|P|your doctor before breastfeeding.||
2454|148|B|||
2454|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2454|150|I|medications work or increase your risk for serious side effects.||
2454|151|I|This document does not contain all possible drug interactions.||
2454|152|I|Keep a list of all the products you use (including||
2454|153|I|prescription/nonprescription drugs and herbal products) and share||
2454|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
2454|155|I|the dosage of any medicines without your doctor's approval.||
2454|156|I|   Other medications can affect the removal of posaconazole from||
2454|157|I|your body, which may affect how posaconazole works. Examples||
2454|158|I|include efavirenz, rifamycins (such as rifabutin), certain drugs||
2454|159|I|used to treat seizures (such as phenytoin), among others.||
2454|160|I|   This drug can slow down the removal of other drugs from your||
2454|161|I|body, which may affect how they work. Examples of affected drugs||
2454|162|I|include certain alpha blockers (such as alfuzosin, silodosin,||
2454|163|I|tamsulosin), certain benzodiazepines (such as midazolam),||
2454|164|I|dronedarone, ergot alkaloids (such as ergotamine,||
2454|165|I|dihydroergotamine), pimozide, quinidine, rivaroxaban, sirolimus,||
2454|166|I|certain "statin" drugs (such as lovastatin, simvastatin),||
2454|167|I|venetoclax, among others.||
2454|168|I|   Many drugs besides posaconazole may affect the heart rhythm||
2454|169|I|(QT prolongation), such as pacritinib, among others.||
2454|170|B|||
2454|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2454|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2454|173|O|poison control center right away. US residents can call||
2454|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2454|175|B|||
2454|176|N|NOTES:  Do not share this medication with others.||
2454|177|N|   This medication has been prescribed for your current condition||
2454|178|N|only. Do not use it later to prevent another infection unless||
2454|179|N|your doctor tells you to.||
2454|180|N|   Lab and/or medical tests (such as liver function, blood||
2454|181|N|pressure, blood mineral levels such as calcium, magnesium,||
2454|182|N|potassium) should be done before you start using this medication||
2454|183|N|and while you are using it. Keep all medical and lab||
2454|184|N|appointments. Consult your doctor for more details.||
2454|185|B|||
2454|186|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2454|187|D|remember. If it is near the time of the next dose, skip the||
2454|188|D|missed dose. Take your next dose at the regular time. Do not||
2454|189|D|double the dose to catch up.||
2454|190|B|||
2454|191|R|STORAGE:  Store at room temperature away from moisture. Do not||
2454|192|R|store in the bathroom. Keep all medications away from children||
2454|193|R|and pets.||
2454|194|R|   Do not flush medications down the toilet or pour them into a||
2454|195|R|drain unless instructed to do so. Properly discard this product||
2454|196|R|when it is expired or no longer needed. Consult your pharmacist||
2454|197|R|or local waste disposal company.||
2454|198|B|||
2454|199|A|Information last revised April 2025.||
2454|200|A|Copyright(c) 2025 First Databank, Inc.||
2454|201|B|||
2455|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2455|002|Z|does NOT have all possible information about this product. This||
2455|003|Z|information does not assure that this product is safe, effective,||
2455|004|Z|or appropriate for you. This information is not individual||
2455|005|Z|medical advice and does not substitute for the advice of your||
2455|006|Z|health care professional. Always ask your health care||
2455|007|Z|professional for complete information about this product and your||
2455|008|Z|specific health needs.||
2455|009|B|||
2455|010|T|TECLISTAMAB - INJECTION||
2455|011|B|||
2455|012|C|COMMON BRAND NAME(S): Tecvayli||
2455|013|B|||
2455|014|W|WARNING:  This medication may cause a serious (even fatal)||
2455|015|W|reaction called cytokine release syndrome-CRS. Careful monitoring||
2455|016|W|and prompt treatment may decrease your risk. Before treatment||
2455|017|W|with this medication, tell your doctor your medical history,||
2455|018|W|especially of any current/recent infection. Tell your doctor||
2455|019|W|right away if you have any symptoms of CRS such as high fever,||
2455|020|W|trouble breathing, chills, dizziness/lightheadedness, fast||
2455|021|W|heartbeat, confusion, or headache.||
2455|022|W|   Teclistamab can cause serious nervous system problems. Tell||
2455|023|W|your doctor right away if you have any symptoms such as headache,||
2455|024|W|trouble speaking, shaking, jerking movements, numbness/tingling,||
2455|025|W|muscle spasms, changes in your handwriting, double vision,||
2455|026|W|problems walking, muscle weakness in your body or face, hearing||
2455|027|W|loss, or burning/throbbing/stabbing pain.||
2455|028|W|   To receive teclistamab in the United States, you must||
2455|029|W|understand, agree to, and carefully follow the requirements of||
2455|030|W|the REMS Program for this medication. If you live in Canada or||
2455|031|W|any other country, consult your doctor and pharmacist for your||
2455|032|W|country's regulations.||
2455|033|B|||
2455|034|U|USES:  This medication is used to treat a certain type of cancer||
2455|035|U|(multiple myeloma). Teclistamab belongs to a class of drugs known||
2455|036|U|as monoclonal antibodies. It works by slowing or stopping the||
2455|037|U|growth of cancer cells.||
2455|038|B|||
2455|039|H|HOW TO USE:  Read the Medication Guide provided by your||
2455|040|H|pharmacist before you start using teclistamab. If you have any||
2455|041|H|questions, ask your doctor or pharmacist. Carry the Patient||
2455|042|H|Wallet Card with you at all times. Show the card to all of your||
2455|043|H|health care providers to let them know that you are being treated||
2455|044|H|with teclistamab.||
2455|045|H|   This medication is given by injection under the skin as||
2455|046|H|directed by your doctor. The injection is given by a health care||
2455|047|H|professional, usually under the skin of the abdomen or thigh. To||
2455|048|H|reduce your risk of side effects, your doctor will start this||
2455|049|H|medication at a low dose and gradually increase your dose. These||
2455|050|H|starting doses are part of a "step-up dosing schedule." You must||
2455|051|H|stay in the hospital for 48 hours after each of the "step-up"||
2455|052|H|doses so your doctor can monitor you closely and help you manage||
2455|053|H|any side effects. Your doctor should also give you other||
2455|054|H|medications (such as acetaminophen, dexamethasone,||
2455|055|H|diphenhydramine). Carefully follow your doctor's directions for||
2455|056|H|all your medications.||
2455|057|H|   The dosage and treatment schedule are based on your medical||
2455|058|H|condition, weight, and response to treatment.||
2455|059|B|||
2455|060|S|SIDE EFFECTS:  See also Warning section.||
2455|061|S|   Tiredness, muscle/joint pain, nausea, vomiting, loss of||
2455|062|S|appetite, constipation, or diarrhea may occur. Pain, bruising,||
2455|063|S|redness, itching, or swelling at the injection site may also||
2455|064|S|occur. If any of these effects last or get worse, tell your||
2455|065|S|doctor or pharmacist promptly.||
2455|066|S|   People using this medication may have serious side effects.||
2455|067|S|However, you have been prescribed this drug because your doctor||
2455|068|S|has judged that the benefit to you is greater than the risk of||
2455|069|S|side effects. Careful monitoring by your doctor may decrease your||
2455|070|S|risk.||
2455|071|S|   This medication may raise your blood pressure. Check your||
2455|072|S|blood pressure regularly and tell your doctor if the results are||
2455|073|S|high.||
2455|074|S|   Tell your doctor right away if you have any serious side||
2455|075|S|effects, including: easy bruising/bleeding.||
2455|076|S|   This medication may lower your ability to fight infections.||
2455|077|S|This may make you more likely to get a serious (rarely fatal)||
2455|078|S|infection or make any infection you have worse. Tell your doctor||
2455|079|S|right away if you have any signs of infection (such as sore||
2455|080|S|throat that doesn't go away, fever, chills).||
2455|081|S|   Teclistamab may rarely cause serious (possibly fatal) liver||
2455|082|S|disease. Get medical help right away if you have any symptoms of||
2455|083|S|liver damage, such as: nausea/vomiting that doesn't stop,||
2455|084|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
2455|085|S|   A very serious allergic reaction to this drug is rare.||
2455|086|S|However, get medical help right away if you notice any symptoms||
2455|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2455|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2455|089|S|breathing.||
2455|090|S|   This is not a complete list of possible side effects. If you||
2455|091|S|notice other effects not listed above, contact your doctor or||
2455|092|S|pharmacist.||
2455|093|S|   In the US -||
2455|094|S|   Call your doctor for medical advice about side effects. You||
2455|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2455|096|S|www.fda.gov/medwatch.||
2455|097|S|   In Canada - Call your doctor for medical advice about side||
2455|098|S|effects. You may report side effects to Health Canada at||
2455|099|S|1-866-234-2345.||
2455|100|B|||
2455|101|P|PRECAUTIONS:  Before using teclistamab, tell your doctor or||
2455|102|P|pharmacist if you are allergic to it; or if you have any other||
2455|103|P|allergies. This product may contain inactive ingredients, which||
2455|104|P|can cause allergic reactions or other problems. Talk to your||
2455|105|P|pharmacist for more details.||
2455|106|P|   Before using this medication, tell your doctor or pharmacist||
2455|107|P|your medical history, especially of: high blood pressure.||
2455|108|P|   Teclistamab can make you more likely to get infections or may||
2455|109|P|make current infections worse. Stay away from anyone who has an||
2455|110|P|infection that may easily spread (such as chickenpox, COVID-19,||
2455|111|P|measles, flu). Talk to your doctor if you have been exposed to an||
2455|112|P|infection or for more details.||
2455|113|P|   Tell your health care professional that you are using||
2455|114|P|teclistamab before having any immunizations/vaccinations. Avoid||
2455|115|P|contact with people who have recently received live vaccines||
2455|116|P|(such as flu vaccine inhaled through the nose).||
2455|117|P|   To lower the chance of getting cut, bruised, or injured, use||
2455|118|P|caution with sharp objects like razors and nail cutters, and||
2455|119|P|avoid activities such as contact sports.||
2455|120|P|   This drug may make you dizzy or affect your thinking and||
2455|121|P|coordination. Alcohol or marijuana (cannabis) can worsen these||
2455|122|P|effects. Do not drive, use machinery, or do anything that needs||
2455|123|P|alertness until you can do it safely. Limit alcoholic beverages.||
2455|124|P|Talk to your doctor if you are using marijuana (cannabis).||
2455|125|P|   Before having surgery, tell your doctor or dentist about all||
2455|126|P|the products you use (including prescription drugs,||
2455|127|P|nonprescription drugs, and herbal products).||
2455|128|P|   Tell your doctor if you are pregnant or plan to become||
2455|129|P|pregnant. You should not become pregnant while using teclistamab.||
2455|130|P|Teclistamab may harm an unborn baby. Your doctor should order a||
2455|131|P|pregnancy test before you start this medication. Ask about||
2455|132|P|reliable forms of birth control while using this medication and||
2455|133|P|for 5 months after the last dose. If you become pregnant, talk to||
2455|134|P|your doctor right away about the risks and benefits of this||
2455|135|P|medication.||
2455|136|P|   It is unknown if this drug passes into breast milk. Because of||
2455|137|P|the possible risk to the infant, breastfeeding is not recommended||
2455|138|P|while using this drug and for 5 months after the last dose.||
2455|139|P|Consult your doctor before breastfeeding.||
2455|140|B|||
2455|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2455|142|I|medications work or increase your risk for serious side effects.||
2455|143|I|This document does not contain all possible drug interactions.||
2455|144|I|Keep a list of all the products you use (including||
2455|145|I|prescription/nonprescription drugs and herbal products) and share||
2455|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
2455|147|I|the dosage of any medicines without your doctor's approval.||
2455|148|B|||
2455|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2455|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2455|151|O|poison control center right away. US residents can call||
2455|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2455|153|B|||
2455|154|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2455|155|N|liver function) should be done while you are using this||
2455|156|N|medication. Keep all medical and lab appointments.||
2455|157|B|||
2455|158|D|MISSED DOSE:  It is important to get each dose of this medication||
2455|159|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2455|160|D|right away for a new dosing schedule.||
2455|161|B|||
2455|162|R|STORAGE:  Not applicable. This medication is given in a hospital||
2455|163|R|or clinic and will not be stored at home.||
2455|164|B|||
2455|165|M|MEDICAL ALERT:  Your condition can cause complications in a||
2455|166|M|medical emergency. For information about enrolling in MedicAlert,||
2455|167|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2455|168|B|||
2455|169|A|Information last revised April 2025.||
2455|170|A|Copyright(c) 2025 First Databank, Inc.||
2455|171|B|||
2456|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2456|002|Z|does NOT have all possible information about this product. This||
2456|003|Z|information does not assure that this product is safe, effective,||
2456|004|Z|or appropriate for you. This information is not individual||
2456|005|Z|medical advice and does not substitute for the advice of your||
2456|006|Z|health care professional. Always ask your health care||
2456|007|Z|professional for complete information about this product and your||
2456|008|Z|specific health needs.||
2456|009|B|||
2456|010|T|MIRVETUXIMAB SORAVTANSINE - INJECTION||
2456|011|F|(MIR-ve-TUX-i-mab SOE-rav-TAN-seen)||
2456|012|B|||
2456|013|C|COMMON BRAND NAME(S): Elahere||
2456|014|B|||
2456|015|W|WARNING:  This medication may cause eye problems that can be||
2456|016|W|serious (such as changes in vision, decreased/blurred vision, dry||
2456|017|W|eyes, eye redness/pain, sensitivity to light). Your doctor will||
2456|018|W|have you do eye exams before starting and during treatment with||
2456|019|W|this medication. Your doctor may also prescribe eye medications||
2456|020|W|or products (such as lubricant eye drops, steroids such as||
2456|021|W|prednisolone) to lessen the risk or severity of eye problems.||
2456|022|W|Tell your doctor right away if you have new or worsening eye||
2456|023|W|symptoms.||
2456|024|B|||
2456|025|U|USES:  This medication is used to treat certain cancers (such as||
2456|026|U|epithelial ovarian, fallopian tube, primary peritoneal).||
2456|027|U|Mirvetuximab soravtansine works by slowing or stopping the growth||
2456|028|U|of cancer cells.||
2456|029|B|||
2456|030|H|HOW TO USE:  Read the Medication Guide provided by your||
2456|031|H|pharmacist before you start using mirvetuximab soravtansine and||
2456|032|H|each time you get a refill. If you have any questions, ask your||
2456|033|H|doctor or pharmacist.||
2456|034|H|   This medication is given by injection into a vein as directed||
2456|035|H|by your doctor, usually every 3 weeks. The injection is given by||
2456|036|H|a health care professional. Infusion reactions may happen during||
2456|037|H|the infusion of this drug. Your doctor may prescribe other||
2456|038|H|medications before each treatment to help prevent these side||
2456|039|H|effects. Tell your doctor right away if you have any symptoms of||
2456|040|H|infusion reactions such shaking, chest tightness, chills,||
2456|041|H|flushing, fast heartbeat, or dizziness.||
2456|042|H|   The dosage and treatment schedule are based on your medical||
2456|043|H|condition, weight, and response to treatment.||
2456|044|B|||
2456|045|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2456|046|S|   Tiredness, nausea, vomiting, diarrhea or constipation, loss of||
2456|047|S|appetite, abdominal pain, or muscle/joint pain may occur. Nausea||
2456|048|S|and vomiting can be severe. Your doctor may prescribe medication||
2456|049|S|to prevent or relieve nausea and vomiting. Eating several small||
2456|050|S|meals, not eating before treatment, or limiting activity may help||
2456|051|S|lessen some of these effects. If any of these effects last or get||
2456|052|S|worse, tell your doctor or pharmacist promptly.||
2456|053|S|   People using this medication may have serious side effects.||
2456|054|S|However, you have been prescribed this drug because your doctor||
2456|055|S|has judged that the benefit to you is greater than the risk of||
2456|056|S|side effects. Careful monitoring by your doctor may decrease your||
2456|057|S|risk.||
2456|058|S|   Tell your doctor right away if you have any serious side||
2456|059|S|effects, including: symptoms of lung problems (such as cough,||
2456|060|S|shortness of breath), numbness/tingling/burning sensation||
2456|061|S|(including in the arms or legs), muscle weakness, change in sense||
2456|062|S|of touch.||
2456|063|S|   This medication may lower your ability to fight infections.||
2456|064|S|This may make you more likely to get a serious (rarely fatal)||
2456|065|S|infection or make any infection you have worse. Tell your doctor||
2456|066|S|right away if you have any signs of infection (such as sore||
2456|067|S|throat that doesn't go away, fever, chills).||
2456|068|S|   A very serious allergic reaction to this drug is rare.||
2456|069|S|However, get medical help right away if you notice any symptoms||
2456|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2456|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2456|072|S|breathing.||
2456|073|S|   This is not a complete list of possible side effects. If you||
2456|074|S|notice other effects not listed above, contact your doctor or||
2456|075|S|pharmacist.||
2456|076|S|   In the US -||
2456|077|S|   Call your doctor for medical advice about side effects. You||
2456|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2456|079|S|www.fda.gov/medwatch.||
2456|080|S|   In Canada - Call your doctor for medical advice about side||
2456|081|S|effects. You may report side effects to Health Canada at||
2456|082|S|1-866-234-2345.||
2456|083|B|||
2456|084|P|PRECAUTIONS:  See also Warning section.||
2456|085|P|   Before using mirvetuximab soravtansine, tell your doctor or||
2456|086|P|pharmacist if you are allergic to it; or if you have any other||
2456|087|P|allergies. This product may contain inactive ingredients, which||
2456|088|P|can cause allergic reactions or other problems. Talk to your||
2456|089|P|pharmacist for more details.||
2456|090|P|   Before using this medication, tell your doctor or pharmacist||
2456|091|P|your medical history.||
2456|092|P|   Mirvetuximab soravtansine can make you more likely to get||
2456|093|P|infections or may make current infections worse. Stay away from||
2456|094|P|anyone who has an infection that may easily spread (such as||
2456|095|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
2456|096|P|have been exposed to an infection or for more details.||
2456|097|P|   Tell your health care professional that you are using||
2456|098|P|mirvetuximab soravtansine before having any||
2456|099|P|immunizations/vaccinations. Avoid contact with people who have||
2456|100|P|recently received live vaccines (such as flu vaccine inhaled||
2456|101|P|through the nose).||
2456|102|P|   To lower the chance of getting cut, bruised, or injured, use||
2456|103|P|caution with sharp objects like razors and nail cutters, and||
2456|104|P|avoid activities such as contact sports.||
2456|105|P|   This drug may cause vision changes such as decreased or||
2456|106|P|blurred vision. Do not drive, use machinery, or do anything that||
2456|107|P|needs clear vision until you can do it safely.||
2456|108|P|   Before having surgery, tell your doctor or dentist about all||
2456|109|P|the products you use (including prescription drugs,||
2456|110|P|nonprescription drugs, and herbal products).||
2456|111|P|   Tell your doctor if you are pregnant or plan to become||
2456|112|P|pregnant. You should not become pregnant while using mirvetuximab||
2456|113|P|soravtansine. Mirvetuximab soravtansine may harm an unborn baby.||
2456|114|P|Your doctor should order a pregnancy test before you start this||
2456|115|P|medication. Ask about reliable forms of birth control while using||
2456|116|P|this medication and for 7 months after the last dose. If you||
2456|117|P|become pregnant, talk to your doctor right away about the risks||
2456|118|P|and benefits of this medication.||
2456|119|P|   It is unknown if this drug passes into breast milk. Because of||
2456|120|P|the possible risk to the infant, breastfeeding is not recommended||
2456|121|P|while using this drug and for 1 month after the last dose.||
2456|122|P|Consult your doctor before breastfeeding.||
2456|123|B|||
2456|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2456|125|I|medications work or increase your risk for serious side effects.||
2456|126|I|This document does not contain all possible drug interactions.||
2456|127|I|Keep a list of all the products you use (including||
2456|128|I|prescription/nonprescription drugs and herbal products) and share||
2456|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
2456|130|I|the dosage of any medicines without your doctor's approval.||
2456|131|B|||
2456|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2456|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2456|134|O|poison control center right away. US residents can call||
2456|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2456|136|B|||
2456|137|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2456|138|N|eye exams, kidney/liver function) should be done before starting||
2456|139|N|and while you are using this medication. Keep all medical and lab||
2456|140|N|appointments.||
2456|141|B|||
2456|142|D|MISSED DOSE:  It is important to get each dose of this medication||
2456|143|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2456|144|D|right away for a new dosing schedule.||
2456|145|B|||
2456|146|R|STORAGE:  Not applicable. This medication is given in a hospital||
2456|147|R|or clinic and will not be stored at home.||
2456|148|B|||
2456|149|M|MEDICAL ALERT:  Your condition can cause complications in a||
2456|150|M|medical emergency. For information about enrolling in MedicAlert,||
2456|151|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2456|152|B|||
2456|153|A|Information last revised April 2025.||
2456|154|A|Copyright(c) 2025 First Databank, Inc.||
2456|155|B|||
2457|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2457|002|Z|does NOT have all possible information about this product. This||
2457|003|Z|information does not assure that this product is safe, effective,||
2457|004|Z|or appropriate for you. This information is not individual||
2457|005|Z|medical advice and does not substitute for the advice of your||
2457|006|Z|health care professional. Always ask your health care||
2457|007|Z|professional for complete information about this product and your||
2457|008|Z|specific health needs.||
2457|009|B|||
2457|010|T|TEPLIZUMAB - INJECTION||
2457|011|F|(tep-LIZ-ue-mab)||
2457|012|B|||
2457|013|C|COMMON BRAND NAME(S): Tzield||
2457|014|B|||
2457|015|U|USES:  Teplizumab is used to slow down the worsening of type 1||
2457|016|U|diabetes. It may delay the need to use insulin to treat your type||
2457|017|U|1 diabetes. Teplizumab belongs to a class of drugs known as||
2457|018|U|monoclonal antibodies. It works by preventing your immune system||
2457|019|U|from attacking your pancreas, which makes insulin in your body.||
2457|020|B|||
2457|021|H|HOW TO USE:  Read the Medication Guide provided by your||
2457|022|H|pharmacist before you start receiving teplizumab and each time||
2457|023|H|you get a treatment. If you have any questions, ask your doctor||
2457|024|H|or pharmacist.||
2457|025|H|   This medication is given by injection into a vein by a health||
2457|026|H|care professional. It is given as directed by your doctor,||
2457|027|H|usually once a day for 14 days. It is injected slowly into a vein||
2457|028|H|over 30 minutes.||
2457|029|H|   The dosage is based on your medical condition, body size, and||
2457|030|H|response to treatment.||
2457|031|H|   Before each dose, your doctor may direct you to take other||
2457|032|H|medications to help prevent side effects. Carefully follow your||
2457|033|H|doctor's directions for all your medications. Your doctor may||
2457|034|H|stop your treatment for some time if you get serious side||
2457|035|H|effects.||
2457|036|H|   To get the most benefit, do not miss any doses. To help you||
2457|037|H|remember, mark your calendar with a reminder.||
2457|038|B|||
2457|039|S|SIDE EFFECTS:  Headache may occur. If this effect lasts or gets||
2457|040|S|worse, tell your doctor or pharmacist promptly.||
2457|041|S|   Remember that this medication has been prescribed because your||
2457|042|S|doctor has judged that the benefit to you is greater than the||
2457|043|S|risk of side effects. Many people using this medication do not||
2457|044|S|have serious side effects.||
2457|045|S|   This medication may cause a serious reaction called cytokine||
2457|046|S|release syndrome-CRS. Careful monitoring and prompt treatment may||
2457|047|S|decrease your risk. Before treatment with this medication, tell||
2457|048|S|your doctor your medical history, especially of any||
2457|049|S|current/recent infection. Tell your doctor right away if you have||
2457|050|S|any symptoms of CRS such as fever, severe nausea, tiredness,||
2457|051|S|severe muscle/joint pain, or severe headache.||
2457|052|S|   This medication may lower your ability to fight infections.||
2457|053|S|This may make you more likely to get a serious (rarely fatal)||
2457|054|S|infection or make any infection you have worse. Tell your doctor||
2457|055|S|right away if you have any signs of infection (such as sore||
2457|056|S|throat that doesn't go away, fever, chills).||
2457|057|S|   A very serious allergic reaction to this drug is rare.||
2457|058|S|However, get medical help right away if you notice any symptoms||
2457|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2457|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2457|061|S|breathing.||
2457|062|S|   This is not a complete list of possible side effects. If you||
2457|063|S|notice other effects not listed above, contact your doctor or||
2457|064|S|pharmacist.||
2457|065|S|   In the US -||
2457|066|S|   Call your doctor for medical advice about side effects. You||
2457|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2457|068|S|www.fda.gov/medwatch.||
2457|069|S|   In Canada - Call your doctor for medical advice about side||
2457|070|S|effects. You may report side effects to Health Canada at||
2457|071|S|1-866-234-2345.||
2457|072|B|||
2457|073|P|PRECAUTIONS:  See also Side Effects section.||
2457|074|P|   Before using teplizumab, tell your doctor or pharmacist if you||
2457|075|P|are allergic to it; or if you have any other allergies. This||
2457|076|P|product may contain inactive ingredients, which can cause||
2457|077|P|allergic reactions or other problems. Talk to your pharmacist for||
2457|078|P|more details.||
2457|079|P|   Before using this medication, tell your doctor or pharmacist||
2457|080|P|your medical history, especially of: blood/bone marrow problems||
2457|081|P|(such as low red/white blood cells and platelets), liver disease.||
2457|082|P|   Teplizumab can make you more likely to get infections or may||
2457|083|P|make current infections worse. Stay away from anyone who has an||
2457|084|P|infection that may easily spread (such as chickenpox, COVID-19,||
2457|085|P|measles, flu). Talk to your doctor if you have been exposed to an||
2457|086|P|infection or for more details.||
2457|087|P|   Tell your doctor your vaccine history and ask if you need to||
2457|088|P|get any vaccines before starting treatment with this medication.||
2457|089|P|Your doctor may direct you to have any required vaccines at least||
2457|090|P|2 to 8 weeks before starting this medication. Tell your health||
2457|091|P|care professional that you are using or have used teplizumab||
2457|092|P|before having any immunizations/vaccinations. Avoid contact with||
2457|093|P|people who have recently received live vaccines (such as flu||
2457|094|P|vaccine inhaled through the nose).||
2457|095|P|   Before having surgery, tell your doctor or dentist about all||
2457|096|P|the products you use (including prescription drugs,||
2457|097|P|nonprescription drugs, and herbal products).||
2457|098|P|   Tell your doctor if you are pregnant or plan to become||
2457|099|P|pregnant. You should not become pregnant while using teplizumab.||
2457|100|P|Teplizumab may harm an unborn baby. You should wait at least 30||
2457|101|P|days after the last dose of teplizumab before a planned||
2457|102|P|pregnancy. If you become pregnant while taking this medication,||
2457|103|P|talk to your doctor right away about the risks and benefits.||
2457|104|P|   It is unknown if this drug passes into breast milk. Consult||
2457|105|P|your doctor before breastfeeding.||
2457|106|B|||
2457|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2457|108|I|medications work or increase your risk for serious side effects.||
2457|109|I|This document does not contain all possible drug interactions.||
2457|110|I|Keep a list of all the products you use (including||
2457|111|I|prescription/nonprescription drugs and herbal products) and share||
2457|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2457|113|I|the dosage of any medicines without your doctor's approval.||
2457|114|B|||
2457|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2457|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2457|117|O|poison control center right away. US residents can call||
2457|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2457|119|B|||
2457|120|N|NOTES:  Attend a diabetes education program to learn more about||
2457|121|N|how to manage your diabetes with medications, diet, exercise, and||
2457|122|N|regular medical exams.||
2457|123|N|   Learn the symptoms of high and low blood sugar and how to||
2457|124|N|treat low blood sugar. Check your blood sugar regularly as||
2457|125|N|directed.||
2457|126|N|   Lab and/or medical tests (such as liver function, complete||
2457|127|N|blood count) should be done before you start using this||
2457|128|N|medication and while you are using it. Keep all medical and lab||
2457|129|N|appointments. Consult your doctor for more details.||
2457|130|B|||
2457|131|D|MISSED DOSE:  It is important to get each dose of this medication||
2457|132|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2457|133|D|right away for a new dosing schedule.||
2457|134|B|||
2457|135|R|STORAGE:  Not applicable. This medication is given in a hospital||
2457|136|R|or clinic and will not be stored at home.||
2457|137|B|||
2457|138|M|MEDICAL ALERT:  Your condition can cause complications in a||
2457|139|M|medical emergency. For information about enrolling in MedicAlert,||
2457|140|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2457|141|B|||
2457|142|A|Information last revised April 2025.||
2457|143|A|Copyright(c) 2025 First Databank, Inc.||
2457|144|B|||
2458|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2458|002|Z|does NOT have all possible information about this product. This||
2458|003|Z|information does not assure that this product is safe, effective,||
2458|004|Z|or appropriate for you. This information is not individual||
2458|005|Z|medical advice and does not substitute for the advice of your||
2458|006|Z|health care professional. Always ask your health care||
2458|007|Z|professional for complete information about this product and your||
2458|008|Z|specific health needs.||
2458|009|B|||
2458|010|T|ETRANACOGENE DEZAPARVOVEC - INJECTION||
2458|011|B|||
2458|012|C|COMMON BRAND NAME(S): Hemgenix||
2458|013|B|||
2458|014|U|USES:  This medication is used to treat a certain blood clotting||
2458|015|U|disease (hemophilia B). Hemophilia B is a genetic disorder caused||
2458|016|U|by lack of a certain clotting protein (factor IX), or caused by||
2458|017|U|clotting protein that does not work properly. Etranacogene||
2458|018|U|dezaparvovec belongs to a class of drugs known as gene therapy.||
2458|019|U|It works by helping to increase your body's production of normal||
2458|020|U|factor IX. This effect may decrease bleeding problems due to||
2458|021|U|hemophilia B.||
2458|022|B|||
2458|023|H|HOW TO USE:  This medication is given as a one-time dose. Your||
2458|024|H|doctor will do lab/medical tests before and after you receive||
2458|025|H|treatment to monitor for side effects and to see how well it||
2458|026|H|works for you.||
2458|027|H|   This product is given by slow injection into a vein as||
2458|028|H|directed by your doctor. The dosage is based on your body weight.||
2458|029|H|Your doctor will closely monitor you for side effects during and||
2458|030|H|for at least 3 hours after the injection.||
2458|031|H|   Infusion reactions may happen during the infusion of this||
2458|032|H|drug. Tell your doctor right away if you have any symptoms of||
2458|033|H|infusion reactions such as chest tightness, headache, abdominal||
2458|034|H|pain, dizziness, lightheadedness, shaking chills, flushing, or||
2458|035|H|flu-like symptoms. Your doctor may give you other medications to||
2458|036|H|help with these side effects or may slow down or stop your||
2458|037|H|treatment for some time.||
2458|038|B|||
2458|039|S|SIDE EFFECTS:  See also How to Use section.||
2458|040|S|   Remember that this medication has been prescribed because your||
2458|041|S|doctor has judged that the benefit to you is greater than the||
2458|042|S|risk of side effects. Many people using this medication do not||
2458|043|S|have serious side effects.||
2458|044|S|   Etranacogene dezaparvovec may rarely cause serious (possibly||
2458|045|S|fatal) liver disease. Get medical help right away if you have any||
2458|046|S|symptoms of liver damage, such as: nausea/vomiting that doesn't||
2458|047|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
2458|048|S|eyes/skin, dark urine.||
2458|049|S|   A very serious allergic reaction to this drug is rare.||
2458|050|S|However, get medical help right away if you notice any symptoms||
2458|051|S|of a serious allergic reaction, including: rash, itching/swelling||
2458|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2458|053|S|breathing.||
2458|054|S|   This is not a complete list of possible side effects. If you||
2458|055|S|notice other effects not listed above, contact your doctor or||
2458|056|S|pharmacist.||
2458|057|S|   In the US -||
2458|058|S|   Call your doctor for medical advice about side effects. You||
2458|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2458|060|S|www.fda.gov/medwatch.||
2458|061|S|   In Canada - Call your doctor for medical advice about side||
2458|062|S|effects. You may report side effects to Health Canada at||
2458|063|S|1-866-234-2345.||
2458|064|B|||
2458|065|P|PRECAUTIONS:  Before receiving this product, tell your doctor or||
2458|066|P|pharmacist if you have any allergies. This product may contain||
2458|067|P|inactive ingredients, which can cause allergic reactions or other||
2458|068|P|problems. Talk to your pharmacist for more details.||
2458|069|P|   Before using this medication, tell your doctor or pharmacist||
2458|070|P|your medical history, especially of: liver problems (including||
2458|071|P|cirrhosis, fatty liver disease, hepatitis B or C), increased risk||
2458|072|P|of liver problems (such as due to regular overuse of alcohol).||
2458|073|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2458|074|P|can make you more dizzy. Do not drive, use machinery, or do||
2458|075|P|anything that needs alertness until you can do it safely. Limit||
2458|076|P|alcoholic beverages. Talk to your doctor if you are using||
2458|077|P|marijuana (cannabis).||
2458|078|P|   Before having surgery, tell your doctor or dentist about all||
2458|079|P|the products you use (including prescription drugs,||
2458|080|P|nonprescription drugs, and herbal products).||
2458|081|P|   This product is not usually used by women. It is unlikely to||
2458|082|P|be used during pregnancy or breastfeeding. Consult your doctor if||
2458|083|P|you have any questions about this product.||
2458|084|B|||
2458|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2458|086|I|medications work or increase your risk for serious side effects.||
2458|087|I|This document does not contain all possible drug interactions.||
2458|088|I|Keep a list of all the products you use (including||
2458|089|I|prescription/nonprescription drugs and herbal products) and share||
2458|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
2458|091|I|the dosage of any medicines without your doctor's approval.||
2458|092|B|||
2458|093|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2458|094|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2458|095|O|poison control center right away. US residents can call||
2458|096|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2458|097|B|||
2458|098|N|NOTES:  Lab and/or medical tests (such as liver function, factor||
2458|099|N|IX activity and inhibitor levels) must be done before you start||
2458|100|N|and after you receive this medication. Keep all medical and lab||
2458|101|N|appointments.||
2458|102|N|   After receiving this treatment, do not donate blood, organs,||
2458|103|N|tissues, or cells.||
2458|104|B|||
2458|105|D|MISSED DOSE:  Not applicable.||
2458|106|B|||
2458|107|R|STORAGE:  Not applicable. This type of product is given in a||
2458|108|R|hospital or clinic and will not be stored at home.||
2458|109|B|||
2458|110|M|MEDICAL ALERT:  Your condition can cause complications in a||
2458|111|M|medical emergency. For information about enrolling in MedicAlert,||
2458|112|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2458|113|B|||
2458|114|A|Information last revised May 2024.||
2458|115|A|Copyright(c) 2025 First Databank, Inc.||
2458|116|B|||
2459|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2459|002|Z|does NOT have all possible information about this product. This||
2459|003|Z|information does not assure that this product is safe, effective,||
2459|004|Z|or appropriate for you. This information is not individual||
2459|005|Z|medical advice and does not substitute for the advice of your||
2459|006|Z|health care professional. Always ask your health care||
2459|007|Z|professional for complete information about this product and your||
2459|008|Z|specific health needs.||
2459|009|B|||
2459|010|T|OLUTASIDENIB - ORAL||
2459|011|F|(oh-LOO-ta-SID-e-nib)||
2459|012|B|||
2459|013|C|COMMON BRAND NAME(S): Rezlidhia||
2459|014|B|||
2459|015|W|WARNING:  Olutasidenib may cause a serious (possibly fatal)||
2459|016|W|condition called differentiation syndrome. Get medical help right||
2459|017|W|away if you develop any signs of differentiation syndrome, such||
2459|018|W|as fever, cough, shortness of breath, decreased urination, rapid||
2459|019|W|weight gain, or swelling of arms/legs.||
2459|020|B|||
2459|021|U|USES:  This medication is used to treat a certain type of blood||
2459|022|U|cell cancer (acute myeloid leukemia-AML). Olutasidenib works by||
2459|023|U|stopping or slowing the growth of cancer cells.||
2459|024|B|||
2459|025|H|HOW TO USE:  Read the Medication Guide provided by your||
2459|026|H|pharmacist before you start taking olutasidenib and each time you||
2459|027|H|get a refill. If you have any questions, ask your doctor or||
2459|028|H|pharmacist.||
2459|029|H|   Take this medication by mouth as directed by your doctor,||
2459|030|H|usually twice daily (about 12 hours apart). Take it on an empty||
2459|031|H|stomach, at least 1 hour before or 2 hours after a meal. Swallow||
2459|032|H|the capsules whole. Do not break, open, or chew the capsules.||
2459|033|H|   The dosage is based on your medical condition and response to||
2459|034|H|treatment.||
2459|035|H|   Do not increase your dose or use this drug more often or for||
2459|036|H|longer than prescribed. Your condition will not improve any||
2459|037|H|faster, and your risk of serious side effects will increase.||
2459|038|H|   If you vomit after taking a dose, do not take another dose.||
2459|039|H|Take your next dose at the regular time. Do not double the dose||
2459|040|H|to catch up.||
2459|041|B|||
2459|042|S|SIDE EFFECTS:  See also Warning section.||
2459|043|S|   Nausea, vomiting, abdominal pain, diarrhea or constipation,||
2459|044|S|joint pain, headache, dizziness, lightheadedness, or tiredness||
2459|045|S|may occur. Pain or sores in the mouth and throat may occur. Brush||
2459|046|S|your teeth carefully/gently, avoid using mouthwash that contains||
2459|047|S|alcohol, and rinse your mouth often with cool water mixed with||
2459|048|S|baking soda or salt. It may also be best to eat soft, moist||
2459|049|S|foods. If any of these effects last or get worse, tell your||
2459|050|S|doctor or pharmacist promptly.||
2459|051|S|   Remember that this medication has been prescribed because your||
2459|052|S|doctor has judged that the benefit to you is greater than the||
2459|053|S|risk of side effects. Many people using this medication do not||
2459|054|S|have serious side effects.||
2459|055|S|   Tell your doctor right away if you have any serious side||
2459|056|S|effects, including: signs of liver problems (such as||
2459|057|S|nausea/vomiting that doesn't stop, loss of appetite,||
2459|058|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2459|059|S|   Olutasidenib can commonly cause a rash that is usually not||
2459|060|S|serious. However, you may not be able to tell it apart from a||
2459|061|S|rash that could be a sign of a severe reaction. Get medical help||
2459|062|S|right away if you develop any rash.||
2459|063|S|   A very serious allergic reaction to this drug is rare.||
2459|064|S|However, get medical help right away if you notice any symptoms||
2459|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2459|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2459|067|S|breathing.||
2459|068|S|   This is not a complete list of possible side effects. If you||
2459|069|S|notice other effects not listed above, contact your doctor or||
2459|070|S|pharmacist.||
2459|071|S|   In the US -||
2459|072|S|   Call your doctor for medical advice about side effects. You||
2459|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2459|074|S|www.fda.gov/medwatch.||
2459|075|S|   In Canada - Call your doctor for medical advice about side||
2459|076|S|effects. You may report side effects to Health Canada at||
2459|077|S|1-866-234-2345.||
2459|078|B|||
2459|079|P|PRECAUTIONS:  Before taking olutasidenib, tell your doctor or||
2459|080|P|pharmacist if you are allergic to it; or if you have any other||
2459|081|P|allergies. This product may contain inactive ingredients, which||
2459|082|P|can cause allergic reactions or other problems. Talk to your||
2459|083|P|pharmacist for more details.||
2459|084|P|   Before taking this medication, tell your doctor or pharmacist||
2459|085|P|your medical history, especially of: liver problems.||
2459|086|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2459|087|P|can make you more dizzy. Do not drive, use machinery, or do||
2459|088|P|anything that needs alertness until you can do it safely. Limit||
2459|089|P|alcoholic beverages. Talk to your doctor if you are using||
2459|090|P|marijuana (cannabis).||
2459|091|P|   Before having surgery, tell your doctor or dentist about all||
2459|092|P|the products you use (including prescription drugs,||
2459|093|P|nonprescription drugs, and herbal products).||
2459|094|P|   Tell your doctor if you are pregnant or plan to become||
2459|095|P|pregnant. You should not become pregnant while taking||
2459|096|P|olutasidenib. Olutasidenib may harm an unborn baby. If you become||
2459|097|P|pregnant, talk to your doctor right away about the risks and||
2459|098|P|benefits of this medication.||
2459|099|P|   It is unknown if this drug passes into breast milk. Because of||
2459|100|P|the possible risk to the infant, breastfeeding is not recommended||
2459|101|P|while using this drug and for 2 weeks after the last dose.||
2459|102|P|Consult your doctor before breastfeeding.||
2459|103|B|||
2459|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2459|105|I|medications work or increase your risk for serious side effects.||
2459|106|I|This document does not contain all possible drug interactions.||
2459|107|I|Keep a list of all the products you use (including||
2459|108|I|prescription/nonprescription drugs and herbal products) and share||
2459|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
2459|110|I|the dosage of any medicines without your doctor's approval.||
2459|111|I|   Other medications can affect the removal of olutasidenib from||
2459|112|I|your body, which may affect how olutasidenib works. Examples||
2459|113|I|include rifamycins (such as rifabutin, rifampin), St. John's||
2459|114|I|wort, drugs used to treat seizures (such as carbamazepine,||
2459|115|I|phenytoin), among others.||
2459|116|B|||
2459|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2459|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2459|119|O|poison control center right away. US residents can call||
2459|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2459|121|B|||
2459|122|N|NOTES:  Do not share this medication with others.||
2459|123|N|   Lab and/or medical tests (such as liver function, complete||
2459|124|N|blood count, blood mineral levels) should be done before you||
2459|125|N|start taking this medication and while you are taking it. Keep||
2459|126|N|all medical and lab appointments.||
2459|127|B|||
2459|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2459|129|D|remember. If it is less than 8 hours before the next dose, skip||
2459|130|D|the missed dose. Take your next dose at the regular time. Do not||
2459|131|D|double the dose to catch up.||
2459|132|B|||
2459|133|R|STORAGE:  Store at room temperature away from light and moisture.||
2459|134|R|Do not store in the bathroom. Keep all medications away from||
2459|135|R|children and pets.||
2459|136|R|   Do not flush medications down the toilet or pour them into a||
2459|137|R|drain unless instructed to do so. Properly discard this product||
2459|138|R|when it is expired or no longer needed. Consult your pharmacist||
2459|139|R|or local waste disposal company.||
2459|140|B|||
2459|141|A|Information last revised April 2025.||
2459|142|A|Copyright(c) 2025 First Databank, Inc.||
2459|143|B|||
2460|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2460|002|Z|does NOT have all possible information about this product. This||
2460|003|Z|information does not assure that this product is safe, effective,||
2460|004|Z|or appropriate for you. This information is not individual||
2460|005|Z|medical advice and does not substitute for the advice of your||
2460|006|Z|health care professional. Always ask your health care||
2460|007|Z|professional for complete information about this product and your||
2460|008|Z|specific health needs.||
2460|009|B|||
2460|010|T|ADAGRASIB - ORAL||
2460|011|B|||
2460|012|C|COMMON BRAND NAME(S): Krazati||
2460|013|B|||
2460|014|U|USES:  This medication is used to treat certain types of cancer||
2460|015|U|(such as lung, colorectal). It works by slowing or stopping the||
2460|016|U|growth of cancer cells.||
2460|017|B|||
2460|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2460|019|H|from your pharmacist before you start taking adagrasib and each||
2460|020|H|time you get a refill. If you have any questions, ask your doctor||
2460|021|H|or pharmacist.||
2460|022|H|   Take this medication by mouth with or without food as directed||
2460|023|H|by your doctor, usually twice daily. Swallow the tablets whole.||
2460|024|H|Do not chew, crush, or split the tablets.||
2460|025|H|   If you vomit after taking a dose, do not take another dose.||
2460|026|H|Take your next dose at your regular scheduled time.||
2460|027|H|   The dosage is based on your medical condition and response to||
2460|028|H|treatment.||
2460|029|H|   Use this medication regularly to get the most benefit from it.||
2460|030|H|To help you remember, take it at the same times each day.||
2460|031|H|   Do not increase your dose or use this drug more often or for||
2460|032|H|longer than prescribed. Your condition will not improve any||
2460|033|H|faster, and your risk of side effects will increase.||
2460|034|B|||
2460|035|S|SIDE EFFECTS:  Dizziness, muscle/joint pain, tiredness, diarrhea,||
2460|036|S|nausea, or vomiting may occur. Nausea and vomiting can be severe.||
2460|037|S|In some cases, your doctor may prescribe medication to prevent or||
2460|038|S|relieve nausea and vomiting. Eating several small meals, not||
2460|039|S|eating before treatment, or limiting activity may help lessen||
2460|040|S|some of these effects. If any of these effects last or get worse,||
2460|041|S|tell your doctor or pharmacist promptly.||
2460|042|S|   People using this medication may have serious side effects.||
2460|043|S|However, you have been prescribed this drug because your doctor||
2460|044|S|has judged that the benefit to you is greater than the risk of||
2460|045|S|side effects. Careful monitoring by your doctor may decrease your||
2460|046|S|risk.||
2460|047|S|   Tell your doctor right away if you have any serious side||
2460|048|S|effects, including: signs of liver disease (such as||
2460|049|S|nausea/vomiting that doesn't stop, loss of appetite,||
2460|050|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2460|051|S|of kidney problems (such as change in the amount of urine),||
2460|052|S|swelling hands/ankles/feet, severe constipation.||
2460|053|S|   Adagrasib can cause severe (possibly fatal) lung problems.||
2460|054|S|Tell your doctor right away if you have any symptoms of lung||
2460|055|S|problems (such as fever, new or worsening cough/shortness of||
2460|056|S|breath).||
2460|057|S|   This drug may rarely cause serious (rarely fatal) bleeding||
2460|058|S|from the stomach or intestines. If you notice any of the||
2460|059|S|following unlikely but serious side effects, stop taking||
2460|060|S|adagrasib and consult your doctor or pharmacist right away:||
2460|061|S|stomach/abdominal pain that doesn't go away, black stools, vomit||
2460|062|S|that looks like coffee grounds.||
2460|063|S|   Get medical help right away if you have any very serious side||
2460|064|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2460|065|S|fainting.||
2460|066|S|   A very serious allergic reaction to this drug is rare.||
2460|067|S|However, get medical help right away if you notice any symptoms||
2460|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2460|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2460|070|S|breathing.||
2460|071|S|   This is not a complete list of possible side effects. If you||
2460|072|S|notice other effects not listed above, contact your doctor or||
2460|073|S|pharmacist.||
2460|074|S|   In the US -||
2460|075|S|   Call your doctor for medical advice about side effects. You||
2460|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2460|077|S|www.fda.gov/medwatch.||
2460|078|S|   In Canada - Call your doctor for medical advice about side||
2460|079|S|effects. You may report side effects to Health Canada at||
2460|080|S|1-866-234-2345.||
2460|081|B|||
2460|082|P|PRECAUTIONS:  Before taking adagrasib, tell your doctor or||
2460|083|P|pharmacist if you are allergic to it; or if you have any other||
2460|084|P|allergies. This product may contain inactive ingredients, which||
2460|085|P|can cause allergic reactions or other problems. Talk to your||
2460|086|P|pharmacist for more details.||
2460|087|P|   Before using this medication, tell your doctor or pharmacist||
2460|088|P|your medical history, especially of: liver problems.||
2460|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2460|090|P|can make you more dizzy. Do not drive, use machinery, or do||
2460|091|P|anything that needs alertness until you can do it safely. Limit||
2460|092|P|alcoholic beverages. Talk to your doctor if you are using||
2460|093|P|marijuana (cannabis).||
2460|094|P|   Adagrasib may cause a condition that affects the heart rhythm||
2460|095|P|(QT prolongation). QT prolongation can rarely cause serious||
2460|096|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2460|097|P|as severe dizziness, fainting) that need medical attention right||
2460|098|P|away.||
2460|099|P|   The risk of QT prolongation may be increased if you have||
2460|100|P|certain medical conditions or are taking other drugs that may||
2460|101|P|cause QT prolongation. Before using adagrasib, tell your doctor||
2460|102|P|or pharmacist of all the drugs you take and if you have any of||
2460|103|P|the following conditions: certain heart problems (heart failure,||
2460|104|P|slow heartbeat, QT prolongation in the EKG), family history of||
2460|105|P|certain heart problems (QT prolongation in the EKG, sudden||
2460|106|P|cardiac death).||
2460|107|P|   Low levels of potassium or magnesium in the blood may also||
2460|108|P|increase your risk of QT prolongation. This risk may increase if||
2460|109|P|you use certain drugs (such as diuretics/"water pills") or if you||
2460|110|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2460|111|P|Talk to your doctor about using adagrasib safely.||
2460|112|P|   Before having surgery, tell your doctor or dentist about all||
2460|113|P|the products you use (including prescription drugs,||
2460|114|P|nonprescription drugs, and herbal products).||
2460|115|P|   Older adults may be more sensitive to the side effects of this||
2460|116|P|drug, especially QT prolongation (see above).||
2460|117|P|   During pregnancy, this medication should be used only when||
2460|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
2460|119|P|   It is unknown if this drug passes into breast milk. Because of||
2460|120|P|the possible risk to the infant, breastfeeding is not recommended||
2460|121|P|while using this drug and for 1 week after the last dose. Consult||
2460|122|P|your doctor before breastfeeding.||
2460|123|B|||
2460|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2460|125|I|medications work or increase your risk for serious side effects.||
2460|126|I|This document does not contain all possible drug interactions.||
2460|127|I|Keep a list of all the products you use (including||
2460|128|I|prescription/nonprescription drugs and herbal products) and share||
2460|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
2460|130|I|the dosage of any medicines without your doctor's approval.||
2460|131|I|   Other medications can affect the removal of adagrasib from||
2460|132|I|your body, which may affect how adagrasib works. Examples include||
2460|133|I|levoketoconazole, rifamycins (such as rifampin, rifapentine), St.||
2460|134|I|John's wort, drugs used to treat seizures (such as carbamazepine,||
2460|135|I|phenytoin), among others.||
2460|136|I|   This medication can slow down the removal of other medications||
2460|137|I|from your body, which may affect how they work. Examples of||
2460|138|I|affected drugs include avanafil, certain benzodiazepines (such as||
2460|139|I|alprazolam, midazolam, triazolam), dronedarone, finerenone,||
2460|140|I|isavuconazonium, lomitapide, lurasidone, certain statins (such as||
2460|141|I|lovastatin, simvastatin), ticagrelor, among others.||
2460|142|B|||
2460|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2460|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2460|145|O|poison control center right away. US residents can call||
2460|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2460|147|B|||
2460|148|N|NOTES:  Do not share this medication with others.||
2460|149|N|   Lab and/or medical tests (such as liver function, complete||
2460|150|N|blood count, blood mineral levels) should be done before you||
2460|151|N|start taking this medication and while you are taking it. Keep||
2460|152|N|all medical and lab appointments. Consult your doctor for more||
2460|153|N|details.||
2460|154|B|||
2460|155|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2460|156|D|remember. If it is more than 4 hours after the missed dose, skip||
2460|157|D|the missed dose. Take your next dose at the regular time. Do not||
2460|158|D|double the dose to catch up.||
2460|159|B|||
2460|160|R|STORAGE:  Store at room temperature away from light and moisture.||
2460|161|R|Do not store in the bathroom. Keep all medications away from||
2460|162|R|children and pets.||
2460|163|R|   Do not flush medications down the toilet or pour them into a||
2460|164|R|drain unless instructed to do so. Properly discard this product||
2460|165|R|when it is expired or no longer needed. Consult your pharmacist||
2460|166|R|or local waste disposal company.||
2460|167|B|||
2460|168|A|Information last revised June 2024.||
2460|169|A|Copyright(c) 2025 First Databank, Inc.||
2460|170|B|||
2461|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2461|002|Z|does NOT have all possible information about this product. This||
2461|003|Z|information does not assure that this product is safe, effective,||
2461|004|Z|or appropriate for you. This information is not individual||
2461|005|Z|medical advice and does not substitute for the advice of your||
2461|006|Z|health care professional. Always ask your health care||
2461|007|Z|professional for complete information about this product and your||
2461|008|Z|specific health needs.||
2461|009|B|||
2461|010|T|FECAL MICROBIOTA SUSPENSION (LIVE) - RECTAL||
2461|011|B|||
2461|012|C|COMMON BRAND NAME(S): Rebyota||
2461|013|B|||
2461|014|U|USES:  This product is used to help prevent another return of a||
2461|015|U|certain infection (C. difficile-CDI) in the intestines after||
2461|016|U|completing antibiotics for a return of the infection. This||
2461|017|U|product is made from human stool from screened donors. It is||
2461|018|U|thought to work by giving healthy bacteria to you. Treatment can||
2461|019|U|decrease symptoms of CDI such as diarrhea, nausea, loss of||
2461|020|U|appetite, and stomach tenderness or pain.||
2461|021|U|   This product is not used for treatment of CDI.||
2461|022|B|||
2461|023|H|HOW TO USE:  This product is given into the rectum by a health||
2461|024|H|care professional.||
2461|025|H|   For best results, use after emptying your bladder and bowel,||
2461|026|H|if possible. Lie on your left side with the left knee bent toward||
2461|027|H|the chest. Another position that can be used is to kneel, then||
2461|028|H|lower your head and chest forward until the left side of your||
2461|029|H|face is resting on a surface and your left arm is folded||
2461|030|H|comfortably. A health care professional will give this product||
2461|031|H|into your rectum. After receiving this product, stay in your||
2461|032|H|position for up to 15 minutes to decrease cramping that may||
2461|033|H|occur. However, you may use the restroom if needed.||
2461|034|H|   Do not take any antibiotics by mouth for up to 8 weeks after||
2461|035|H|receiving this treatment unless directed by your doctor.||
2461|036|H|   Tell your doctor if your diarrhea does not get better or if it||
2461|037|H|gets worse (if you get 3 or more loose bowel movements within a||
2461|038|H|24-hour period for 2 days in a row).||
2461|039|B|||
2461|040|S|SIDE EFFECTS:  Abdominal pain, diarrhea, bloating, gas, or nausea||
2461|041|S|may occur. If any of these effects last or get worse, tell your||
2461|042|S|doctor or pharmacist promptly.||
2461|043|S|   Remember that this product has been prescribed because your||
2461|044|S|doctor has judged that the benefit to you is greater than the||
2461|045|S|risk of side effects. Many people using this medication do not||
2461|046|S|have serious side effects.||
2461|047|S|   A very serious allergic reaction to this drug is rare.||
2461|048|S|However, get medical help right away if you notice any symptoms||
2461|049|S|of a serious allergic reaction, including: rash, itching/swelling||
2461|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2461|051|S|breathing.||
2461|052|S|   This is not a complete list of possible side effects. If you||
2461|053|S|notice other effects not listed above, contact your doctor or||
2461|054|S|pharmacist.||
2461|055|S|   In the US -||
2461|056|S|   Call your doctor for medical advice about side effects. You||
2461|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2461|058|S|www.fda.gov/medwatch.||
2461|059|S|   In Canada - Call your doctor for medical advice about side||
2461|060|S|effects. You may report side effects to Health Canada at||
2461|061|S|1-866-234-2345.||
2461|062|B|||
2461|063|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2461|064|P|pharmacist if you have any allergies. This product may contain||
2461|065|P|inactive ingredients, which can cause allergic reactions or other||
2461|066|P|problems. Talk to your pharmacist for more details.||
2461|067|P|   Before using this medication, tell your doctor or pharmacist||
2461|068|P|your medical history.||
2461|069|P|   Before having surgery, tell your doctor or dentist about all||
2461|070|P|the products you use (including prescription drugs,||
2461|071|P|nonprescription drugs, and herbal products).||
2461|072|P|   This product is safe to use during pregnancy when used as||
2461|073|P|directed.||
2461|074|P|   It is unknown if this drug passes into breast milk. However,||
2461|075|P|it is unlikely to pass into breast milk. Consult your doctor||
2461|076|P|before breastfeeding.||
2461|077|B|||
2461|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2461|079|I|medications work or increase your risk for serious side effects.||
2461|080|I|This document does not contain all possible drug interactions.||
2461|081|I|Keep a list of all the products you use (including||
2461|082|I|prescription/nonprescription drugs and herbal products) and share||
2461|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
2461|084|I|the dosage of any medicines without your doctor's approval.||
2461|085|B|||
2461|086|O|OVERDOSE:  This product may be harmful if swallowed. If someone||
2461|087|O|has overdosed and has serious symptoms such as passing out or||
2461|088|O|trouble breathing, call 911. Otherwise, call a poison control||
2461|089|O|center right away. US residents can call 1-800-222-1222. Canada||
2461|090|O|residents can call 1-844-764-7669.||
2461|091|B|||
2461|092|N|NOTES:  Lab and/or medical tests (such as stool tests) may be||
2461|093|N|done while you are using this medication. Keep all medical and||
2461|094|N|lab appointments.||
2461|095|B|||
2461|096|D|MISSED DOSE:  Not applicable.||
2461|097|B|||
2461|098|R|STORAGE:  Not applicable. This type of product is given in a||
2461|099|R|hospital or clinic or doctor's office and will not be stored at||
2461|100|R|home.||
2461|101|B|||
2461|102|A|Information last revised May 2024.||
2461|103|A|Copyright(c) 2025 First Databank, Inc.||
2461|104|B|||
2462|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2462|002|Z|does NOT have all possible information about this product. This||
2462|003|Z|information does not assure that this product is safe, effective,||
2462|004|Z|or appropriate for you. This information is not individual||
2462|005|Z|medical advice and does not substitute for the advice of your||
2462|006|Z|health care professional. Always ask your health care||
2462|007|Z|professional for complete information about this product and your||
2462|008|Z|specific health needs.||
2462|009|B|||
2462|010|T|MOSUNETUZUMAB - INJECTION||
2462|011|F|(moe-SUN-e-TOOZ-ue-mab)||
2462|012|B|||
2462|013|C|COMMON BRAND NAME(S): Lunsumio||
2462|014|B|||
2462|015|W|WARNING:  Mosunetuzumab may cause a certain serious (sometimes||
2462|016|W|fatal) side effect known as cytokine release syndrome-CRS. You||
2462|017|W|will be given this medication in a hospital or clinic so your||
2462|018|W|doctor can watch for serious side effects and quickly provide||
2462|019|W|treatment if needed. Tell your doctor right away if you develop||
2462|020|W|symptoms such as fever, chills, headache, nausea, vomiting,||
2462|021|W|stomach/abdominal pain, shortness of breath, skin rash,||
2462|022|W|tiredness, or low blood pressure.||
2462|023|B|||
2462|024|U|USES:  This medication is used to treat a certain type of cancer||
2462|025|U|(follicular lymphoma). Mosunetuzumab belongs to a class of drugs||
2462|026|U|known as monoclonal antibodies. It works by changing the action||
2462|027|U|of your own immune system, directing it to attack cancer cells.||
2462|028|U|This effect helps slow or stop the growth of cancer cells.||
2462|029|B|||
2462|030|H|HOW TO USE:  Read the Medication Guide provided by your||
2462|031|H|pharmacist before you start using mosunetuzumab and each time you||
2462|032|H|get a refill. If you have any questions, ask your doctor or||
2462|033|H|pharmacist.||
2462|034|H|   This medication is given by injection into a vein as directed||
2462|035|H|by your doctor. The injection is given by a health care||
2462|036|H|professional. The first 3 doses are usually given over at least 4||
2462|037|H|hours. If you can take this medication, the following doses may||
2462|038|H|be given over less time (such as 2 hours). The dosage is based on||
2462|039|H|your medical condition and response to treatment.||
2462|040|H|   Infusion reactions may happen during or soon after the||
2462|041|H|infusion of this drug. Your doctor may prescribe other||
2462|042|H|medications (such as acetaminophen, dexamethasone,||
2462|043|H|diphenhydramine) before each treatment to help prevent these side||
2462|044|H|effects. Tell your doctor right away if you have any symptoms of||
2462|045|H|infusion reactions such as flushing, chills, fever, fast/pounding||
2462|046|H|heartbeat, dizziness, or shortness of breath.||
2462|047|H|   Use this medication regularly to get the most benefit from it.||
2462|048|H|To help you remember, mark your calendar with a reminder.||
2462|049|B|||
2462|050|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2462|051|S|   Dizziness, diarrhea, or, muscle/joint pain may occur. If any||
2462|052|S|of these effects last or get worse, tell your doctor or||
2462|053|S|pharmacist promptly.||
2462|054|S|   People using this medication may have serious side effects.||
2462|055|S|However, you have been prescribed this drug because your doctor||
2462|056|S|has judged that the benefit to you is greater than the risk of||
2462|057|S|side effects. Careful monitoring by your doctor may decrease your||
2462|058|S|risk.||
2462|059|S|   Tell your doctor right away if you have any serious side||
2462|060|S|effects, including: easy bruising/bleeding.||
2462|061|S|   This medication can also cause serious (even fatal) nervous||
2462|062|S|system problems. Tell your doctor right away if you have any||
2462|063|S|symptoms such as drowsiness, trouble sleeping, seizures,||
2462|064|S|mental/mood changes (such as confusion, memory loss),||
2462|065|S|numbness/tingling of arms/legs, or trouble with speaking,||
2462|066|S|reading, writing or understanding.||
2462|067|S|   This medication may lower your ability to fight infections.||
2462|068|S|This may make you more likely to get a serious (rarely fatal)||
2462|069|S|infection or make any infection you have worse. Tell your doctor||
2462|070|S|right away if you have any signs of infection (such as sore||
2462|071|S|throat that doesn't go away, fever, chills).||
2462|072|S|   This medication sometimes causes side effects due to the rapid||
2462|073|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
2462|074|S|risk, your doctor may add a medication and tell you to drink||
2462|075|S|plenty of fluids. Tell your doctor right away if you have||
2462|076|S|symptoms such as: low back/side pain (flank pain), signs of||
2462|077|S|kidney problems (such as painful urination, pink/bloody urine,||
2462|078|S|change in the amount of urine), muscle spasms/weakness.||
2462|079|S|   People taking this medication may have worsening of their||
2462|080|S|symptoms (tumor flare). Tell your doctor right away if you have||
2462|081|S|symptoms of tumor flare such as: tender or swollen lymph nodes,||
2462|082|S|chest pain, cough, or pain or swelling at the site of the tumor.||
2462|083|S|   Mosunetuzumab can commonly cause a rash that is usually not||
2462|084|S|serious. However, you may not be able to tell it apart from a||
2462|085|S|rare rash that could be a sign of a severe reaction. Get medical||
2462|086|S|help right away if you develop any rash.||
2462|087|S|   A very serious allergic reaction to this drug is rare.||
2462|088|S|However, get medical help right away if you notice any symptoms||
2462|089|S|of a serious allergic reaction, including: rash, itching/swelling||
2462|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2462|091|S|breathing.||
2462|092|S|   This is not a complete list of possible side effects. If you||
2462|093|S|notice other effects not listed above, contact your doctor or||
2462|094|S|pharmacist.||
2462|095|S|   In the US -||
2462|096|S|   Call your doctor for medical advice about side effects. You||
2462|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2462|098|S|www.fda.gov/medwatch.||
2462|099|S|   In Canada - Call your doctor for medical advice about side||
2462|100|S|effects. You may report side effects to Health Canada at||
2462|101|S|1-866-234-2345.||
2462|102|B|||
2462|103|P|PRECAUTIONS:  Before using mosunetuzumab, tell your doctor or||
2462|104|P|pharmacist if you are allergic to it; or if you have any other||
2462|105|P|allergies. This product may contain inactive ingredients, which||
2462|106|P|can cause allergic reactions or other problems. Talk to your||
2462|107|P|pharmacist for more details.||
2462|108|P|   Before using this medication, tell your doctor or pharmacist||
2462|109|P|your medical history, especially of: past/current/recent||
2462|110|P|infections (including Epstein-Barr virus).||
2462|111|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2462|112|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2462|113|P|machinery, or do anything that needs alertness until you can do||
2462|114|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2462|115|P|are using marijuana (cannabis).||
2462|116|P|   This medication can make you more likely to get infections or||
2462|117|P|may make current infections worse. Stay away from anyone who has||
2462|118|P|an infection that may easily spread (such as chickenpox,||
2462|119|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2462|120|P|exposed to an infection or for more details.||
2462|121|P|   Tell your health care professional that you are using||
2462|122|P|mosunetuzumab before having any immunizations/vaccinations. Avoid||
2462|123|P|contact with people who have recently received live vaccines||
2462|124|P|(such as flu vaccine inhaled through the nose).||
2462|125|P|   To lower the chance of getting cut, bruised, or injured, use||
2462|126|P|caution with sharp objects like razors and nail cutters, and||
2462|127|P|avoid activities such as contact sports.||
2462|128|P|   Before having surgery, tell your doctor or dentist about all||
2462|129|P|the products you use (including prescription drugs,||
2462|130|P|nonprescription drugs, and herbal products).||
2462|131|P|   Tell your doctor if you are pregnant or plan to become||
2462|132|P|pregnant. You should not become pregnant while using||
2462|133|P|mosunetuzumab. Mosunetuzumab may harm an unborn baby. Your doctor||
2462|134|P|should order a pregnancy test before you start this medication.||
2462|135|P|Ask about reliable forms of birth control while using this||
2462|136|P|medication and for 3 months after the last dose. If you become||
2462|137|P|pregnant, talk to your doctor right away about the risks and||
2462|138|P|benefits of this medication.||
2462|139|P|   It is unknown if this medication passes into breast milk.||
2462|140|P|Because of the possible risk to the infant, breastfeeding is not||
2462|141|P|recommended while using this medication and for 3 months after||
2462|142|P|the last dose. Consult your doctor before breastfeeding.||
2462|143|B|||
2462|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2462|145|I|medications work or increase your risk for serious side effects.||
2462|146|I|This document does not contain all possible drug interactions.||
2462|147|I|Keep a list of all the products you use (including||
2462|148|I|prescription/nonprescription drugs and herbal products) and share||
2462|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
2462|150|I|the dosage of any medicines without your doctor's approval.||
2462|151|B|||
2462|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2462|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2462|154|O|poison control center right away. US residents can call||
2462|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2462|156|B|||
2462|157|N|NOTES:  Lab and/or medical tests (such as complete blood count)||
2462|158|N|should be done while you are using this medication. Keep all||
2462|159|N|medical and lab appointments.||
2462|160|B|||
2462|161|D|MISSED DOSE:  It is important to get each dose of this medication||
2462|162|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2462|163|D|right away for a new dosing schedule.||
2462|164|B|||
2462|165|R|STORAGE:  Not applicable. This medication is given in a hospital||
2462|166|R|or clinic or doctor's office and will not be stored at home.||
2462|167|B|||
2462|168|M|MEDICAL ALERT:  Your condition can cause complications in a||
2462|169|M|medical emergency. For information about enrolling in MedicAlert,||
2462|170|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2462|171|B|||
2462|172|A|Information last revised April 2025.||
2462|173|A|Copyright(c) 2025 First Databank, Inc.||
2462|174|B|||
2463|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2463|002|Z|does NOT have all possible information about this product. This||
2463|003|Z|information does not assure that this product is safe, effective,||
2463|004|Z|or appropriate for you. This information is not individual||
2463|005|Z|medical advice and does not substitute for the advice of your||
2463|006|Z|health care professional. Always ask your health care||
2463|007|Z|professional for complete information about this product and your||
2463|008|Z|specific health needs.||
2463|009|B|||
2463|010|T|LENACAPAVIR - INJECTION||
2463|011|B|||
2463|012|C|COMMON BRAND NAME(S): Sunlenca, Yeztugo||
2463|013|B|||
2463|014|W|WARNING:  If you are using this medication to prevent HIV||
2463|015|W|infection, you must first get tested to be sure you are||
2463|016|W|HIV-negative. Your doctor will perform lab tests before starting||
2463|017|W|this medication and during treatment to make sure that you do not||
2463|018|W|have HIV infection. Using this medication will not always prevent||
2463|019|W|HIV infection. To get the most benefit from it, use this||
2463|020|W|medication exactly as directed, and follow all prevention||
2463|021|W|actions. (See also Uses section.) Tell your doctor right away if||
2463|022|W|you have any signs of HIV infection (such as sore throat that||
2463|023|W|doesn't go away, tiredness, fever, night sweats, diarrhea,||
2463|024|W|joint/muscle aches, enlarged lymph nodes).||
2463|025|B|||
2463|026|U|USES:  Lenacapavir is used with other HIV medications to help||
2463|027|U|control HIV infection. It helps to decrease the amount of HIV in||
2463|028|U|your body so your immune system can work better. This lowers your||
2463|029|U|chance of getting HIV complications (such as new infections,||
2463|030|U|cancer) and improves your quality of life. Lenacapavir belongs to||
2463|031|U|a class of drugs known as capsid inhibitors. It blocks the virus||
2463|032|U|from growing and infecting more cells.||
2463|033|U|   This medication is also used to help prevent HIV infection in||
2463|034|U|people who have a high risk for infection. Some things that||
2463|035|U|increase risk include having a partner infected with HIV, having||
2463|036|U|unprotected sex, having multiple sex partners, infection with a||
2463|037|U|sexually transmitted disease-STD, or use/abuse of drugs or||
2463|038|U|alcohol.||
2463|039|U|   Lenacapavir is not a cure for HIV infection. To decrease your||
2463|040|U|risk of spreading HIV disease to others, continue to take all HIV||
2463|041|U|medications exactly as prescribed by your doctor. Use an||
2463|042|U|effective barrier method (latex or polyurethane condoms/dental||
2463|043|U|dams) during sexual activity as directed by your doctor. Do not||
2463|044|U|share personal items (such as needles/syringes, toothbrushes, and||
2463|045|U|razors) that may have contacted blood or other body fluids.||
2463|046|U|Consult your doctor or pharmacist for more details.||
2463|047|U|   There are 2 different brands used for treatment and prevention||
2463|048|U|of HIV. Do not switch brands of lenacapavir without checking with||
2463|049|U|your doctor.||
2463|050|B|||
2463|051|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2463|052|H|from your pharmacist before you start using lenacapavir and each||
2463|053|H|time you get a refill. If you have any questions, ask your doctor||
2463|054|H|or pharmacist.||
2463|055|H|   This medication is given by injection under the skin as||
2463|056|H|directed by your doctor, usually once every 6 months. It is given||
2463|057|H|by injection into the stomach/abdomen area by a health care||
2463|058|H|professional. At the beginning of treatment, you will also be||
2463|059|H|using the tablet form of the medication for 2 or 3 doses. Follow||
2463|060|H|your doctor's instructions carefully on when to take the tablet||
2463|061|H|form of lenacapavir and when to get your injection of||
2463|062|H|lenacapavir.||
2463|063|H|   It is very important to keep using this medication (and other||
2463|064|H|HIV medications) exactly as prescribed by your doctor. Do not||
2463|065|H|skip any doses.||
2463|066|H|   For the best effect, use this medication at evenly spaced||
2463|067|H|times. To help you remember, mark your calendar with a reminder.||
2463|068|H|If you miss or will miss a planned injection by more than 2||
2463|069|H|weeks, tell your health care professional right away so that you||
2463|070|H|may be given directions for your continued HIV treatment.||
2463|071|H|   Do not stop using this drug (or other HIV medicines) even for||
2463|072|H|a short time unless directed to do so by your doctor. Doing so||
2463|073|H|may cause the amount of virus to increase, make the infection||
2463|074|H|more difficult to treat (resistant).||
2463|075|B|||
2463|076|S|SIDE EFFECTS:  Injection site pain, swelling, redness, itching,||
2463|077|S|bruising, or a hardened mass or lump may occur. Nausea may also||
2463|078|S|occur. If any of these effects last or get worse, tell your||
2463|079|S|doctor or pharmacist promptly.||
2463|080|S|   Remember that this medication has been prescribed because your||
2463|081|S|doctor has judged that the benefit to you is greater than the||
2463|082|S|risk of side effects. Many people using this medication do not||
2463|083|S|have serious side effects.||
2463|084|S|   As your immune system gets stronger with HIV treatment, it can||
2463|085|S|begin to fight off infections you already had, possibly causing||
2463|086|S|disease symptoms to come back. You could also have symptoms if||
2463|087|S|your immune system becomes overactive. This reaction may happen||
2463|088|S|at any time (soon after starting HIV treatment or many months||
2463|089|S|later). Tell your doctor right away if you have any serious||
2463|090|S|symptoms, including: unexplained weight loss, severe tiredness,||
2463|091|S|muscle aches/weakness that doesn't go away, headaches that are||
2463|092|S|severe or don't go away, joint pain, numbness/tingling of the||
2463|093|S|hands/feet/arms/legs, vision changes, signs of infection (such as||
2463|094|S|sore throat that doesn't go away, fever, chills, swollen lymph||
2463|095|S|nodes, non-healing skin sores), signs of an overactive thyroid||
2463|096|S|(such as irritability, nervousness, heat intolerance,||
2463|097|S|fast/pounding/irregular heartbeat), signs of liver disease (such||
2463|098|S|as nausea/vomiting that doesn't stop, loss of appetite,||
2463|099|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2463|100|S|   A very serious allergic reaction to this drug is rare.||
2463|101|S|However, get medical help right away if you notice any symptoms||
2463|102|S|of a serious allergic reaction, including: rash, itching/swelling||
2463|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2463|104|S|breathing.||
2463|105|S|   This is not a complete list of possible side effects. If you||
2463|106|S|notice other effects not listed above, contact your doctor or||
2463|107|S|pharmacist.||
2463|108|S|   In the US -||
2463|109|S|   Call your doctor for medical advice about side effects. You||
2463|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2463|111|S|www.fda.gov/medwatch.||
2463|112|S|   In Canada - Call your doctor for medical advice about side||
2463|113|S|effects. You may report side effects to Health Canada at||
2463|114|S|1-866-234-2345.||
2463|115|B|||
2463|116|P|PRECAUTIONS:  Before using lenacapavir, tell your doctor or||
2463|117|P|pharmacist if you are allergic to it; or if you have any other||
2463|118|P|allergies. This product may contain inactive ingredients, which||
2463|119|P|can cause allergic reactions or other problems. Talk to your||
2463|120|P|pharmacist for more details.||
2463|121|P|   Before using this medication, tell your doctor or pharmacist||
2463|122|P|your medical history.||
2463|123|P|   Before having surgery, tell your doctor or dentist about all||
2463|124|P|the products you use (including prescription drugs,||
2463|125|P|nonprescription drugs, and herbal products).||
2463|126|P|   During pregnancy, this medication should be used only when||
2463|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
2463|128|P|If you have HIV infection, treatment can lower the risk of||
2463|129|P|passing HIV infection to your baby, and this medication may be||
2463|130|P|part of that treatment.||
2463|131|P|   This medication passes into breast milk. Because breast milk||
2463|132|P|may transmit HIV, consult your doctor before breastfeeding.||
2463|133|B|||
2463|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2463|135|I|medications work or increase your risk for serious side effects.||
2463|136|I|This document does not contain all possible drug interactions.||
2463|137|I|Keep a list of all the products you use (including||
2463|138|I|prescription/nonprescription drugs and herbal products) and share||
2463|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
2463|140|I|the dosage of any medicines without your doctor's approval.||
2463|141|I|   Other medications can affect the removal of lenacapavir from||
2463|142|I|your body, which may affect how lenacapavir works. Examples||
2463|143|I|include certain other HIV drugs (such as atazanavir/cobicistat,||
2463|144|I|atazanavir/ritonavir, efavirenz, nevirapine,||
2463|145|I|tipranavir/ritonavir), rifamycins (such as rifampin, rifabutin),||
2463|146|I|certain drugs used to treat seizures (such as carbamazepine,||
2463|147|I|oxcarbazepine, phenobarbital, phenytoin), St. John's wort, among||
2463|148|I|others.||
2463|149|I|   This medication can slow down the removal of other medications||
2463|150|I|from your body (for up to 9 months after the last dose), which||
2463|151|I|may affect how they work. Examples of affected drugs include||
2463|152|I|elacestrant, ergot drugs (such as dihydroergotamine, ergotamine),||
2463|153|I|flibanserin, lomitapide, rivaroxaban, among others.||
2463|154|B|||
2463|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2463|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2463|157|O|poison control center right away. US residents can call||
2463|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2463|159|B|||
2463|160|N|NOTES:  Lab and/or medical tests (such as viral load, T-cell||
2463|161|N|counts) should be done while you are using this medication. Keep||
2463|162|N|all medical and lab appointments. Consult your doctor for more||
2463|163|N|details.||
2463|164|B|||
2463|165|D|MISSED DOSE:  It is important to get each dose of this medication||
2463|166|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2463|167|D|right away for a new dosing schedule.||
2463|168|B|||
2463|169|R|STORAGE:  Not applicable. This product is given in a hospital or||
2463|170|R|clinic or doctor's office and will not be stored at home.||
2463|171|B|||
2463|172|A|Information last revised October 2025.||
2463|173|A|Copyright(c) 2025 First Databank, Inc.||
2463|174|B|||
2464|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2464|002|Z|does NOT have all possible information about this product. This||
2464|003|Z|information does not assure that this product is safe, effective,||
2464|004|Z|or appropriate for you. This information is not individual||
2464|005|Z|medical advice and does not substitute for the advice of your||
2464|006|Z|health care professional. Always ask your health care||
2464|007|Z|professional for complete information about this product and your||
2464|008|Z|specific health needs.||
2464|009|B|||
2464|010|T|LENACAPAVIR - ORAL||
2464|011|B|||
2464|012|C|COMMON BRAND NAME(S): Sunlenca, Yeztugo||
2464|013|B|||
2464|014|W|WARNING:  If you are taking this medication to prevent HIV||
2464|015|W|infection, you must first get tested to be sure you are||
2464|016|W|HIV-negative. Your doctor will perform lab tests before starting||
2464|017|W|this medication and during treatment to make sure that you do not||
2464|018|W|have HIV infection. Using this medication will not always prevent||
2464|019|W|HIV infection. To get the most benefit from it, take this||
2464|020|W|medication exactly as directed, and follow all prevention||
2464|021|W|actions. (See also Uses section.) Tell your doctor right away if||
2464|022|W|you have any signs of HIV infection (such as sore throat that||
2464|023|W|doesn't go away, tiredness, fever, night sweats, diarrhea,||
2464|024|W|joint/muscle aches, enlarged lymph nodes).||
2464|025|B|||
2464|026|U|USES:  Lenacapavir is used with other HIV medications to help||
2464|027|U|control HIV infection. It helps to decrease the amount of HIV in||
2464|028|U|your body so your immune system can work better. This lowers your||
2464|029|U|chance of getting HIV complications (such as new infections,||
2464|030|U|cancer) and improves your quality of life. Lenacapavir belongs to||
2464|031|U|a class of drugs known as capsid inhibitors. It blocks the virus||
2464|032|U|from growing and infecting more cells.||
2464|033|U|   This medication is also used to help prevent HIV infection in||
2464|034|U|people who have a high risk for infection. Some things that||
2464|035|U|increase risk include having a partner infected with HIV, having||
2464|036|U|unprotected sex, having multiple sex partners, infection with a||
2464|037|U|sexually transmitted disease-STD, or use/abuse of drugs or||
2464|038|U|alcohol.||
2464|039|U|   Lenacapavir is not a cure for HIV infection. To decrease your||
2464|040|U|risk of spreading HIV disease to others, continue to take all HIV||
2464|041|U|medications exactly as prescribed by your doctor. Use an||
2464|042|U|effective barrier method (latex or polyurethane condoms/dental||
2464|043|U|dams) during sexual activity as directed by your doctor. Do not||
2464|044|U|share personal items (such as needles/syringes, toothbrushes, and||
2464|045|U|razors) that may have contacted blood or other body fluids.||
2464|046|U|Consult your doctor or pharmacist for more details.||
2464|047|U|   There are 2 different brands used for treatment and prevention||
2464|048|U|of HIV. Do not switch brands of lenacapavir without checking with||
2464|049|U|your doctor.||
2464|050|B|||
2464|051|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2464|052|H|from your pharmacist before you start using lenacapavir and each||
2464|053|H|time you get a refill. If you have any questions, ask your doctor||
2464|054|H|or pharmacist.||
2464|055|H|   Take this medication by mouth with or without food as directed||
2464|056|H|by your doctor. This form of lenacapavir is used at the beginning||
2464|057|H|of treatment for 2 or 3 doses, before starting treatment with the||
2464|058|H|injectable form given under the skin. After you start treatment||
2464|059|H|with the injectable form, this form may also be used if you miss||
2464|060|H|or will miss a planned injection. Follow your doctor's||
2464|061|H|instructions carefully on when to take the tablet form of||
2464|062|H|lenacapavir and when to get your injection of lenacapavir.||
2464|063|B|||
2464|064|S|SIDE EFFECTS:  Nausea may occur. If this effect lasts or gets||
2464|065|S|worse, tell your doctor or pharmacist promptly.||
2464|066|S|   Remember that this medication has been prescribed because your||
2464|067|S|doctor has judged that the benefit to you is greater than the||
2464|068|S|risk of side effects. Many people using this medication do not||
2464|069|S|have serious side effects.||
2464|070|S|   As your immune system gets stronger with HIV treatment, it can||
2464|071|S|begin to fight off infections you already had, possibly causing||
2464|072|S|disease symptoms to come back. You could also have symptoms if||
2464|073|S|your immune system becomes overactive. This reaction may happen||
2464|074|S|at any time (soon after starting HIV treatment or many months||
2464|075|S|later). Tell your doctor right away if you have any serious||
2464|076|S|symptoms, including: unexplained weight loss, severe tiredness,||
2464|077|S|muscle aches/weakness that doesn't go away, headaches that are||
2464|078|S|severe or don't go away, joint pain, numbness/tingling of the||
2464|079|S|hands/feet/arms/legs, vision changes, signs of infection (such as||
2464|080|S|sore throat that doesn't go away, fever, chills, swollen lymph||
2464|081|S|nodes, non-healing skin sores), signs of an overactive thyroid||
2464|082|S|(such as irritability, nervousness, heat intolerance,||
2464|083|S|fast/pounding/irregular heartbeat), signs of liver disease (such||
2464|084|S|as nausea/vomiting that doesn't stop, loss of appetite,||
2464|085|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2464|086|S|   A very serious allergic reaction to this drug is rare.||
2464|087|S|However, get medical help right away if you notice any symptoms||
2464|088|S|of a serious allergic reaction, including: rash, itching/swelling||
2464|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2464|090|S|breathing.||
2464|091|S|   This is not a complete list of possible side effects. If you||
2464|092|S|notice other effects not listed above, contact your doctor or||
2464|093|S|pharmacist.||
2464|094|S|   In the US -||
2464|095|S|   Call your doctor for medical advice about side effects. You||
2464|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2464|097|S|www.fda.gov/medwatch.||
2464|098|S|   In Canada - Call your doctor for medical advice about side||
2464|099|S|effects. You may report side effects to Health Canada at||
2464|100|S|1-866-234-2345.||
2464|101|B|||
2464|102|P|PRECAUTIONS:  Before taking lenacapavir, tell your doctor or||
2464|103|P|pharmacist if you are allergic to it; or if you have any other||
2464|104|P|allergies. This product may contain inactive ingredients, which||
2464|105|P|can cause allergic reactions or other problems. Talk to your||
2464|106|P|pharmacist for more details.||
2464|107|P|   Before using this medication, tell your doctor or pharmacist||
2464|108|P|your medical history.||
2464|109|P|   Before having surgery, tell your doctor or dentist about all||
2464|110|P|the products you use (including prescription drugs,||
2464|111|P|nonprescription drugs, and herbal products).||
2464|112|P|   During pregnancy, this medication should be used only when||
2464|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
2464|114|P|If you have HIV infection, treatment can lower the risk of||
2464|115|P|passing HIV infection to your baby, and this medication may be||
2464|116|P|part of that treatment.||
2464|117|P|   This medication passes into breast milk. Because breast milk||
2464|118|P|may transmit HIV, consult your doctor before breastfeeding.||
2464|119|B|||
2464|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2464|121|I|medications work or increase your risk for serious side effects.||
2464|122|I|This document does not contain all possible drug interactions.||
2464|123|I|Keep a list of all the products you use (including||
2464|124|I|prescription/nonprescription drugs and herbal products) and share||
2464|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
2464|126|I|the dosage of any medicines without your doctor's approval.||
2464|127|I|   Other medications can affect the removal of lenacapavir from||
2464|128|I|your body, which may affect how lenacapavir works. Examples||
2464|129|I|include certain other HIV drugs (such as atazanavir/cobicistat,||
2464|130|I|atazanavir/ritonavir, efavirenz, nevirapine,||
2464|131|I|tipranavir/ritonavir), rifamycins (such as rifampin, rifabutin),||
2464|132|I|certain drugs used to treat seizures (such as carbamazepine,||
2464|133|I|oxcarbazepine, phenobarbital, phenytoin), St. John's wort, among||
2464|134|I|others.||
2464|135|I|   This medication can slow down the removal of other medications||
2464|136|I|from your body, which may affect how they work. Examples of||
2464|137|I|affected drugs include elacestrant, ergot drugs (such as||
2464|138|I|dihydroergotamine, ergotamine), flibanserin, lomitapide,||
2464|139|I|rivaroxaban, among others.||
2464|140|B|||
2464|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2464|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2464|143|O|poison control center right away. US residents can call||
2464|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2464|145|B|||
2464|146|N|NOTES:  Do not share this medication with others.||
2464|147|N|   Lab and/or medical tests (such as viral load, T-cell counts)||
2464|148|N|should be done while you are taking this medication. Keep all||
2464|149|N|medical and lab appointments. Consult your doctor for more||
2464|150|N|details.||
2464|151|B|||
2464|152|D|MISSED DOSE:  It is important to take each dose of this||
2464|153|D|medication as scheduled. If you miss a dose, ask your doctor or||
2464|154|D|pharmacist right away for a new dosing schedule. Do not double||
2464|155|D|the dose to catch up.||
2464|156|B|||
2464|157|R|STORAGE:  Store in the original bottle at room temperature away||
2464|158|R|from light and moisture. Do not store in the bathroom. Keep the||
2464|159|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
2464|160|R|when not in use. If your tablets are in a blister package, keep||
2464|161|R|the medication in the blister package until ready to use. Keep||
2464|162|R|all medications away from children and pets.||
2464|163|R|   Do not flush medications down the toilet or pour them into a||
2464|164|R|drain unless instructed to do so. Properly discard this product||
2464|165|R|when it is expired or no longer needed. Consult your pharmacist||
2464|166|R|or local waste disposal company.||
2464|167|B|||
2464|168|A|Information last revised October 2025.||
2464|169|A|Copyright(c) 2025 First Databank, Inc.||
2464|170|B|||
2465|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2465|002|Z|does NOT have all possible information about this product. This||
2465|003|Z|information does not assure that this product is safe, effective,||
2465|004|Z|or appropriate for you. This information is not individual||
2465|005|Z|medical advice and does not substitute for the advice of your||
2465|006|Z|health care professional. Always ask your health care||
2465|007|Z|professional for complete information about this product and your||
2465|008|Z|specific health needs.||
2465|009|B|||
2465|010|T|CARGLUMIC ACID DISPERSIBLE TABLET - ORAL||
2465|011|F|(kar-GLOO-mik AS-id)||
2465|012|B|||
2465|013|C|COMMON BRAND NAME(S): Carbaglu||
2465|014|B|||
2465|015|U|USES:  This medication is used to help treat certain inherited||
2465|016|U|disorders that cause high levels of a certain substance (ammonia)||
2465|017|U|to build up in your body. Carglumic acid works by helping your||
2465|018|U|body remove ammonia. Too much ammonia in the body can cause brain||
2465|019|U|damage and sometimes death.||
2465|020|B|||
2465|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2465|022|H|Instructions for Use if available from your pharmacist before you||
2465|023|H|start taking carglumic acid and each time you get a refill. If||
2465|024|H|you have any questions, ask your doctor or pharmacist.||
2465|025|H|   Take this medication by mouth right before meals or feedings||
2465|026|H|as directed by your doctor, usually 2 to 4 times daily. The||
2465|027|H|dosage is based on your medical condition, weight, and response||
2465|028|H|to treatment.||
2465|029|H|   This medication must be mixed in water before taking. Use at||
2465|030|H|least one-half teaspoonful/2.5 milliliters water to mix with each||
2465|031|H|tablet of carglumic acid. Place the water and tablet(s) in a cup||
2465|032|H|and stir well until the tablet(s) break into small pieces. The||
2465|033|H|tablet(s) will not completely dissolve. Drink all of the mixture||
2465|034|H|right away. Add more water to the cup and drink all of the||
2465|035|H|mixture to make sure you are getting all of the drug. Use only||
2465|036|H|water for mixing, and do not prepare a supply ahead of time. Do||
2465|037|H|not crush the tablets or swallow them whole.||
2465|038|H|   The mixture may also be given with an oral syringe or through||
2465|039|H|a tube into the stomach. If you are using either of these, ask||
2465|040|H|your health care professional for detailed instructions on how to||
2465|041|H|give it.||
2465|042|H|   Use this medication regularly to get the most benefit from it.||
2465|043|H|To help you remember, take it at the same times each day.||
2465|044|H|   Do not increase your dose or use this drug more often or for||
2465|045|H|longer than prescribed. Your condition will not improve any||
2465|046|H|faster, and your risk of side effects will increase.||
2465|047|H|   Tell your doctor if your condition does not get better or if||
2465|048|H|it gets worse.||
2465|049|B|||
2465|050|S|SIDE EFFECTS:  Upset stomach or vomiting may occur. If either of||
2465|051|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2465|052|S|promptly.||
2465|053|S|   Remember that this medication has been prescribed because your||
2465|054|S|doctor has judged that the benefit to you is greater than the||
2465|055|S|risk of side effects. Many people using this medication do not||
2465|056|S|have serious side effects.||
2465|057|S|   A very serious allergic reaction to this drug is rare.||
2465|058|S|However, get medical help right away if you notice any symptoms||
2465|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2465|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2465|061|S|breathing.||
2465|062|S|   This is not a complete list of possible side effects. If you||
2465|063|S|notice other effects not listed above, contact your doctor or||
2465|064|S|pharmacist.||
2465|065|S|   In the US -||
2465|066|S|   Call your doctor for medical advice about side effects. You||
2465|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2465|068|S|www.fda.gov/medwatch.||
2465|069|S|   In Canada - Call your doctor for medical advice about side||
2465|070|S|effects. You may report side effects to Health Canada at||
2465|071|S|1-866-234-2345.||
2465|072|B|||
2465|073|P|PRECAUTIONS:  Before taking carglumic acid, tell your doctor or||
2465|074|P|pharmacist if you are allergic to it; or if you have any other||
2465|075|P|allergies. This product may contain inactive ingredients, which||
2465|076|P|can cause allergic reactions or other problems. Talk to your||
2465|077|P|pharmacist for more details.||
2465|078|P|   Before using this medication, tell your doctor or pharmacist||
2465|079|P|your medical history, especially of: kidney problems.||
2465|080|P|   Before having surgery, tell your doctor or dentist about all||
2465|081|P|the products you use (including prescription drugs,||
2465|082|P|nonprescription drugs, and herbal products).||
2465|083|P|   During pregnancy, this medication should be used only when||
2465|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
2465|085|P|   It is unknown if this medication passes into breast milk.||
2465|086|P|Consult your doctor before breastfeeding.||
2465|087|B|||
2465|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2465|089|I|medications work or increase your risk for serious side effects.||
2465|090|I|This document does not contain all possible drug interactions.||
2465|091|I|Keep a list of all the products you use (including||
2465|092|I|prescription/nonprescription drugs and herbal products) and share||
2465|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
2465|094|I|the dosage of any medicines without your doctor's approval.||
2465|095|B|||
2465|096|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2465|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2465|098|O|poison control center right away. US residents can call||
2465|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2465|100|B|||
2465|101|N|NOTES:  Do not share this medication with others.||
2465|102|N|   Lab and/or medical tests (such as ammonia blood levels, kidney||
2465|103|N|function, complete blood count) should be done while you are||
2465|104|N|taking this medication. Keep all medical and lab appointments.||
2465|105|B|||
2465|106|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2465|107|D|remember. If it is near the time of the next dose, skip the||
2465|108|D|missed dose. Take your next dose at the regular time. Do not||
2465|109|D|double the dose to catch up.||
2465|110|B|||
2465|111|R|STORAGE:  Different brands of this medication have different||
2465|112|R|storage needs. Check the product package for instructions on how||
2465|113|R|to store your brand, or ask your pharmacist. Keep all medications||
2465|114|R|away from children and pets.||
2465|115|R|   Do not flush medications down the toilet or pour them into a||
2465|116|R|drain unless instructed to do so. Properly discard this product||
2465|117|R|when it is expired or no longer needed. Consult your pharmacist||
2465|118|R|or local waste disposal company.||
2465|119|B|||
2465|120|A|Information last revised May 2024.||
2465|121|A|Copyright(c) 2025 First Databank, Inc.||
2465|122|B|||
2467|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2467|002|Z|does NOT have all possible information about this product. This||
2467|003|Z|information does not assure that this product is safe, effective,||
2467|004|Z|or appropriate for you. This information is not individual||
2467|005|Z|medical advice and does not substitute for the advice of your||
2467|006|Z|health care professional. Always ask your health care||
2467|007|Z|professional for complete information about this product and your||
2467|008|Z|specific health needs.||
2467|009|B|||
2467|010|T|UBLITUXIMAB - INJECTION||
2467|011|F|(UE-bli-TUX-i-mab)||
2467|012|B|||
2467|013|C|COMMON BRAND NAME(S): Briumvi||
2467|014|B|||
2467|015|U|USES:  This medication is used to treat multiple sclerosis (MS).||
2467|016|U|Ublituximab is not a cure for MS but it is thought to help by||
2467|017|U|preventing immune system cells (lymphocytes) from attacking the||
2467|018|U|nerves in your brain and spinal cord. Ublituximab belongs to a||
2467|019|U|class of drugs known as monoclonal antibodies. It helps decrease||
2467|020|U|the number of episodes of disease worsening (relapses) and may||
2467|021|U|prevent or delay disability.||
2467|022|B|||
2467|023|H|HOW TO USE:  Read the Medication Guide provided by your||
2467|024|H|pharmacist before you start using ublituximab and each time you||
2467|025|H|get an infusion. If you have any questions, ask your doctor or||
2467|026|H|pharmacist.||
2467|027|H|   This medication is given by a health care professional. It is||
2467|028|H|given as directed by your doctor on a treatment schedule. It is||
2467|029|H|injected slowly into a vein over 1 to 4 hours depending on your||
2467|030|H|treatment schedule. The first 2 infusions are usually given 2||
2467|031|H|weeks apart. After that, an infusion is usually given once every||
2467|032|H|24 weeks. Follow your doctor's treatment schedule.||
2467|033|H|   Infusion reactions may happen during the infusion of this drug||
2467|034|H|and for up to 24 hours afterward. Your doctor may prescribe other||
2467|035|H|medications (such as methylprednisolone, diphenhydramine) before||
2467|036|H|each treatment to help prevent these side effects. Tell your||
2467|037|H|doctor right away if you have symptoms of infusion reactions such||
2467|038|H|as rash, itching, trouble breathing, throat swelling/pain, fever,||
2467|039|H|chills, fainting, flushing of the face, nausea, headache,||
2467|040|H|dizziness, or fast heartbeat. Your doctor may slow down or stop||
2467|041|H|your treatment for some time.||
2467|042|H|   The dosage and treatment schedule are based on your medical||
2467|043|H|condition and response to treatment. Use this medication||
2467|044|H|regularly to get the most benefit from it. To help you remember,||
2467|045|H|mark your calendar with a reminder.||
2467|046|B|||
2467|047|S|SIDE EFFECTS:  See also How to Use section.||
2467|048|S|   Cold symptoms such as stuffy/runny nose or cough may occur. If||
2467|049|S|any of these effects last or get worse, tell your doctor or||
2467|050|S|pharmacist promptly.||
2467|051|S|   Remember that this medication has been prescribed because your||
2467|052|S|doctor has judged that the benefit to you is greater than the||
2467|053|S|risk of side effects. Many people using this medication do not||
2467|054|S|have serious side effects.||
2467|055|S|   Tell your doctor right away if you have any serious side||
2467|056|S|effects, including: signs of liver problems (such as||
2467|057|S|nausea/vomiting that doesn't stop, loss of appetite,||
2467|058|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2467|059|S|   This medication may lower your ability to fight infections.||
2467|060|S|This may make you more likely to get a serious (rarely fatal)||
2467|061|S|infection or make any infection you have worse. Tell your doctor||
2467|062|S|right away if you have any signs of infections (such as sore||
2467|063|S|throat that doesn't go away, fever, chills, painful urination).||
2467|064|S|   This medication may increase your risk of getting a rare but||
2467|065|S|very serious (possibly fatal) brain infection (progressive||
2467|066|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2467|067|S|if you have any of these new or worsening side effects:||
2467|068|S|clumsiness, loss of coordination/balance, weakness, sudden change||
2467|069|S|in your thinking (such as confusion, difficulty concentrating,||
2467|070|S|memory loss), difficulty talking/walking, seizure, vision||
2467|071|S|changes.||
2467|072|S|   A very serious allergic reaction to this drug is rare.||
2467|073|S|However, get medical help right away if you notice any symptoms||
2467|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2467|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2467|076|S|breathing.||
2467|077|S|   This is not a complete list of possible side effects. If you||
2467|078|S|notice other effects not listed above, contact your doctor or||
2467|079|S|pharmacist.||
2467|080|S|   In the US -||
2467|081|S|   Call your doctor for medical advice about side effects. You||
2467|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2467|083|S|www.fda.gov/medwatch.||
2467|084|S|   In Canada - Call your doctor for medical advice about side||
2467|085|S|effects. You may report side effects to Health Canada at||
2467|086|S|1-866-234-2345.||
2467|087|B|||
2467|088|P|PRECAUTIONS:  Before using ublituximab, tell your doctor or||
2467|089|P|pharmacist if you are allergic to it; or if you have any other||
2467|090|P|allergies. This product may contain inactive ingredients, which||
2467|091|P|can cause allergic reactions or other problems. Talk to your||
2467|092|P|pharmacist for more details.||
2467|093|P|   Before using this medication, tell your doctor or pharmacist||
2467|094|P|your medical history, especially of: current/past/returning||
2467|095|P|infections (such as herpes, tuberculosis), liver problems (such||
2467|096|P|as hepatitis B).||
2467|097|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2467|098|P|can make you more dizzy. Do not drive, use machinery, or do||
2467|099|P|anything that needs alertness until you can do it safely. Limit||
2467|100|P|alcoholic beverages. Talk to your doctor if you are using||
2467|101|P|marijuana (cannabis).||
2467|102|P|   Ublituximab can make you more likely to get infections or may||
2467|103|P|make current infections worse. Stay away from anyone who has an||
2467|104|P|infection that may easily spread (such as chickenpox, COVID-19,||
2467|105|P|measles, flu). Talk to your doctor if you have been exposed to an||
2467|106|P|infection or for more details.||
2467|107|P|   Tell your doctor your vaccine history and ask if you need to||
2467|108|P|get any vaccines before starting treatment with this medication.||
2467|109|P|Your doctor may direct you to have any required vaccines at least||
2467|110|P|2 to 4 weeks before starting this medication. Tell your health||
2467|111|P|care professional that you are using ublituximab before having||
2467|112|P|any immunizations/vaccinations. Avoid contact with people who||
2467|113|P|have recently received live vaccines (such as flu vaccine inhaled||
2467|114|P|through the nose).||
2467|115|P|   Before having surgery, tell your doctor or dentist about all||
2467|116|P|the products you use (including prescription drugs,||
2467|117|P|nonprescription drugs, and herbal products).||
2467|118|P|   Tell your doctor if you are pregnant or plan to become||
2467|119|P|pregnant. You should not become pregnant while using ublituximab.||
2467|120|P|Ublituximab may harm an unborn baby. Your doctor should order a||
2467|121|P|pregnancy test before you start this medication. Ask about||
2467|122|P|reliable forms of birth control while using this medication and||
2467|123|P|for 6 months after the last dose. If you become pregnant, talk to||
2467|124|P|your doctor right away about the risks and benefits of this||
2467|125|P|medication.||
2467|126|P|   It is unknown if this medication passes into breast milk.||
2467|127|P|Consult your doctor before breastfeeding.||
2467|128|B|||
2467|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2467|130|I|medications work or increase your risk for serious side effects.||
2467|131|I|This document does not contain all possible drug interactions.||
2467|132|I|Keep a list of all the products you use (including||
2467|133|I|prescription/nonprescription drugs and herbal products) and share||
2467|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
2467|135|I|the dosage of any medicines without your doctor's approval.||
2467|136|I|   Some products that may interact with this drug are: other||
2467|137|I|drugs that weaken the immune system/increase the risk of||
2467|138|I|infection (such as natalizumab, rituximab).||
2467|139|B|||
2467|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2467|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2467|142|O|poison control center right away. US residents can call||
2467|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2467|144|B|||
2467|145|N|NOTES:  Lab and/or medical tests (such as immunoglobulin levels,||
2467|146|N|tests for hepatitis B, liver function) should be done before you||
2467|147|N|start using this medication and while you are using it. Keep all||
2467|148|N|medical and lab appointments. Consult your doctor for more||
2467|149|N|details.||
2467|150|B|||
2467|151|D|MISSED DOSE:  It is important to get each dose of this medication||
2467|152|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2467|153|D|right away for a new dosing schedule.||
2467|154|B|||
2467|155|R|STORAGE:  Not applicable. This medication is given in a hospital||
2467|156|R|or clinic and will not be stored at home.||
2467|157|B|||
2467|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
2467|159|M|medical emergency. For information about enrolling in MedicAlert,||
2467|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2467|161|B|||
2467|162|A|Information last revised August 2025.||
2467|163|A|Copyright(c) 2025 First Databank, Inc.||
2467|164|B|||
2468|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2468|002|Z|does NOT have all possible information about this product. This||
2468|003|Z|information does not assure that this product is safe, effective,||
2468|004|Z|or appropriate for you. This information is not individual||
2468|005|Z|medical advice and does not substitute for the advice of your||
2468|006|Z|health care professional. Always ask your health care||
2468|007|Z|professional for complete information about this product and your||
2468|008|Z|specific health needs.||
2468|009|B|||
2468|010|T|LECANEMAB - INJECTION||
2468|011|F|(lek-AN-e-mab)||
2468|012|B|||
2468|013|C|COMMON BRAND NAME(S): Leqembi||
2468|014|B|||
2468|015|W|WARNING:  This medication may increase your risk of serious||
2468|016|W|(possibly fatal) side effects such as temporary swelling of the||
2468|017|W|brain, or small spots of bleeding in or on the surface of the||
2468|018|W|brain. These side effects are also known as amyloid-related||
2468|019|W|imaging abnormalities (ARIA). Your doctor may order a genetic||
2468|020|W|test to measure your risk for ARIA before you start this||
2468|021|W|medication. If the genetic test shows you are at greater risk,||
2468|022|W|your doctor should discuss with you the risks and benefits of||
2468|023|W|starting lecanemab. Your doctor will do magnetic resonance||
2468|024|W|imaging (MRI) scans before and during treatment to check for||
2468|025|W|these side effects. If you are also taking medications that can||
2468|026|W|cause bleeding/bruising (including antiplatelet drugs such as||
2468|027|W|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
2468|028|W|such as warfarin/dabigatran), your doctor will monitor you more||
2468|029|W|closely for bleeding. ARIA usually go away over time. They do not||
2468|030|W|always cause symptoms, but tell your doctor right away if you||
2468|031|W|develop symptoms such as headache, dizziness, nausea, confusion,||
2468|032|W|seizures, trouble walking, or vision changes.||
2468|033|B|||
2468|034|U|USES:  This medication is used to treat Alzheimer's disease. It||
2468|035|U|is thought to work by decreasing a certain substance (amyloid||
2468|036|U|beta) that builds up in the brain of a person with Alzheimer's||
2468|037|U|disease. Lecanemab belongs to a class of drugs known as||
2468|038|U|monoclonal antibodies. This medication is not a cure for||
2468|039|U|Alzheimer's disease. It may help slow down worsening of this||
2468|040|U|disease and may delay disability.||
2468|041|B|||
2468|042|H|HOW TO USE:  Read the Medication Guide provided by your||
2468|043|H|pharmacist before you start using lecanemab and each time you||
2468|044|H|receive an injection. If you have any questions, ask your doctor||
2468|045|H|or pharmacist.||
2468|046|H|   This medication is given by injection into a vein as directed||
2468|047|H|by your doctor, usually every 2 or 4 weeks. The injection is||
2468|048|H|given by a health care professional, usually over 1 hour. The||
2468|049|H|dosage is based on your medical condition, weight, and response||
2468|050|H|to treatment.||
2468|051|H|   Infusion reactions may happen during the infusion of this drug||
2468|052|H|and for some time afterward. Your doctor may prescribe other||
2468|053|H|medications before each treatment to help prevent these side||
2468|054|H|effects. Tell your doctor right away if you have any symptoms of||
2468|055|H|infusion reactions such as shortness of breath, fever, chills,||
2468|056|H|joint pain, nausea, vomiting, or dizziness. Your doctor may slow||
2468|057|H|down or stop your infusion for some time.||
2468|058|H|   Use this medication regularly to get the most benefit from it.||
2468|059|H|To help you remember, mark your calendar with a reminder.||
2468|060|B|||
2468|061|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2468|062|S|   Remember that this medication has been prescribed because your||
2468|063|S|doctor has judged that the benefit to you is greater than the||
2468|064|S|risk of side effects. Many people using this medication do not||
2468|065|S|have serious side effects.||
2468|066|S|   A very serious allergic reaction to this drug is rare.||
2468|067|S|However, get medical help right away if you notice any symptoms||
2468|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2468|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2468|070|S|breathing.||
2468|071|S|   This is not a complete list of possible side effects. If you||
2468|072|S|notice other effects not listed above, contact your doctor or||
2468|073|S|pharmacist.||
2468|074|S|   In the US -||
2468|075|S|   Call your doctor for medical advice about side effects. You||
2468|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2468|077|S|www.fda.gov/medwatch.||
2468|078|S|   In Canada - Call your doctor for medical advice about side||
2468|079|S|effects. You may report side effects to Health Canada at||
2468|080|S|1-866-234-2345.||
2468|081|B|||
2468|082|P|PRECAUTIONS:  Before using lecanemab, tell your doctor or||
2468|083|P|pharmacist if you are allergic to it; or if you have any other||
2468|084|P|allergies. This product may contain inactive ingredients, which||
2468|085|P|can cause allergic reactions or other problems. Talk to your||
2468|086|P|pharmacist for more details.||
2468|087|P|   Before using this medication, tell your doctor or pharmacist||
2468|088|P|your medical history.||
2468|089|P|   Before having surgery, tell your doctor or dentist about all||
2468|090|P|the products you use (including prescription drugs,||
2468|091|P|nonprescription drugs, and herbal products).||
2468|092|P|   During pregnancy, this medication should be used only when||
2468|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
2468|094|P|   It is unknown if this medication passes into breast milk.||
2468|095|P|Consult your doctor before breastfeeding.||
2468|096|B|||
2468|097|I|DRUG INTERACTIONS:  See also Warning section.||
2468|098|I|   Drug interactions may change how your medications work or||
2468|099|I|increase your risk for serious side effects. This document does||
2468|100|I|not contain all possible drug interactions. Keep a list of all||
2468|101|I|the products you use (including prescription/nonprescription||
2468|102|I|drugs and herbal products) and share it with your doctor and||
2468|103|I|pharmacist. Do not start, stop, or change the dosage of any||
2468|104|I|medicines without your doctor's approval.||
2468|105|B|||
2468|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2468|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2468|108|O|poison control center right away. US residents can call||
2468|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2468|110|B|||
2468|111|N|NOTES:  Lab and/or medical tests (such as genetic testing, MRI||
2468|112|N|scans, cognitive assessment) should be done before you start||
2468|113|N|using this medication and while you are using it. Keep all||
2468|114|N|medical and lab appointments.||
2468|115|B|||
2468|116|D|MISSED DOSE:  It is important to get each dose of this medication||
2468|117|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2468|118|D|right away for a new dosing schedule.||
2468|119|B|||
2468|120|R|STORAGE:  Not applicable. This medication is given in a hospital||
2468|121|R|or clinic and will not be stored at home.||
2468|122|B|||
2468|123|A|Information last revised September 2025.||
2468|124|A|Copyright(c) 2025 First Databank, Inc.||
2468|125|B|||
2469|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2469|002|Z|does NOT have all possible information about this product. This||
2469|003|Z|information does not assure that this product is safe, effective,||
2469|004|Z|or appropriate for you. This information is not individual||
2469|005|Z|medical advice and does not substitute for the advice of your||
2469|006|Z|health care professional. Always ask your health care||
2469|007|Z|professional for complete information about this product and your||
2469|008|Z|specific health needs.||
2469|009|B|||
2469|010|T|ALGLUCOSIDASE ALFA - INJECTION||
2469|011|F|(AL-gloo-KOE-si-dase AL-fa)||
2469|012|B|||
2469|013|C|COMMON BRAND NAME(S): Lumizyme||
2469|014|B|||
2469|015|W|WARNING:  Alglucosidase alfa may cause serious (sometimes fatal)||
2469|016|W|allergic reactions that may happen during and up to 3 hours after||
2469|017|W|the infusion. Your doctor may prescribe other medications (such||
2469|018|W|as antihistamines, fever reducers, corticosteroids) before each||
2469|019|W|treatment to help prevent these side effects. Get medical help||
2469|020|W|right away if you notice any signs of a serious allergic||
2469|021|W|reaction, such as rash, itching/swelling (especially of the||
2469|022|W|face/tongue/throat), severe dizziness, trouble breathing, or||
2469|023|W|chest pain. Your doctor may give you other medications to help||
2469|024|W|with these side effects or may slow down or stop your treatment||
2469|025|W|for some time.||
2469|026|W|   Rarely, people using this medication have developed severe||
2469|027|W|skin/kidney problems. Tell your doctor right away if you develop||
2469|028|W|changes in skin color, change in the amount of urine, or||
2469|029|W|pink/bloody urine.||
2469|030|W|   Before starting treatment with this medication, tell your||
2469|031|W|doctor if you have a history of heart problems (such as heart||
2469|032|W|failure), breathing problems (such as fluid in the lungs), or||
2469|033|W|swelling. These problems may get worse during the infusion. Your||
2469|034|W|doctor or nurse may monitor you for longer periods after your||
2469|035|W|infusion.||
2469|036|B|||
2469|037|U|USES:  This medication is used by people with a certain inherited||
2469|038|U|condition (Pompe disease) to reduce high levels of a certain||
2469|039|U|substance (glycogen) that builds up in the body. High levels of||
2469|040|U|glycogen in the body may cause muscle weakness, heart problems,||
2469|041|U|and breathing problems. Alglucosidase alfa works by breaking down||
2469|042|U|glycogen.||
2469|043|B|||
2469|044|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2469|045|H|from your pharmacist before you start using alglucosidase alfa||
2469|046|H|and each time you get an infusion. If you have any questions, ask||
2469|047|H|your doctor or pharmacist.||
2469|048|H|   This medication is given by injection into a vein by a health||
2469|049|H|care professional. It is given as directed by your doctor,||
2469|050|H|usually once every 2 weeks. It is injected slowly into a vein||
2469|051|H|over 4 hours. The dosage is based on your medical condition,||
2469|052|H|weight, and response to treatment.||
2469|053|H|   Infusion reactions may happen during the infusion of this drug||
2469|054|H|and for a short time afterward. Tell your doctor right away if||
2469|055|H|you have any symptoms of infusion reactions such as shortness of||
2469|056|H|breath, fever, chills, muscle/joint pain, flushing, fast||
2469|057|H|heartbeat, headache or nausea. Your doctor may give you other||
2469|058|H|medications to help with these side effects or may slow down or||
2469|059|H|stop your treatment for some time.||
2469|060|H|   Use this medication regularly to get the most benefit from it.||
2469|061|H|To help you remember, mark your calendar with a reminder.||
2469|062|B|||
2469|063|S|SIDE EFFECTS:  See also Warning and How To Use sections.||
2469|064|S|   Remember that this medication has been prescribed because your||
2469|065|S|doctor has judged that the benefit to you is greater than the||
2469|066|S|risk of side effects. Many people using this medication do not||
2469|067|S|have serious side effects.||
2469|068|S|   Alglucosidase alfa can commonly cause a rash that is usually||
2469|069|S|not serious. However, you may not be able to tell it apart from a||
2469|070|S|rare rash that could be a sign of a severe reaction. Get medical||
2469|071|S|help right away if you develop any rash.||
2469|072|S|   This is not a complete list of possible side effects. If you||
2469|073|S|notice other effects not listed above, contact your doctor or||
2469|074|S|pharmacist.||
2469|075|S|   In the US -||
2469|076|S|   Call your doctor for medical advice about side effects. You||
2469|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2469|078|S|www.fda.gov/medwatch.||
2469|079|S|   In Canada - Call your doctor for medical advice about side||
2469|080|S|effects. You may report side effects to Health Canada at||
2469|081|S|1-866-234-2345.||
2469|082|B|||
2469|083|P|PRECAUTIONS:  See also Warning section.||
2469|084|P|   Before using alglucosidase alfa, tell your doctor or||
2469|085|P|pharmacist if you are allergic to it; or if you have any other||
2469|086|P|allergies. This product may contain inactive ingredients which||
2469|087|P|can cause allergic reactions or other problems. Talk to your||
2469|088|P|pharmacist for more details.||
2469|089|P|   Before using this medication, tell your doctor or pharmacist||
2469|090|P|your medical history.||
2469|091|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2469|092|P|can make you more dizzy. Do not drive, use machinery, or do||
2469|093|P|anything that needs alertness until you can do it safely. Limit||
2469|094|P|alcoholic beverages. Talk to your doctor if you are using||
2469|095|P|marijuana (cannabis).||
2469|096|P|   Before having surgery, tell your doctor or dentist about all||
2469|097|P|the products you use (including prescription drugs,||
2469|098|P|nonprescription drugs, and herbal products).||
2469|099|P|   During pregnancy, this medication should be used only when||
2469|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
2469|101|P|   This medication passes into breast milk. Consult your doctor||
2469|102|P|before breastfeeding.||
2469|103|B|||
2469|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2469|105|I|medications work or increase your risk for serious side effects.||
2469|106|I|This document does not contain all possible drug interactions.||
2469|107|I|Keep a list of all the products you use (including||
2469|108|I|prescription/nonprescription drugs and herbal products) and share||
2469|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
2469|110|I|the dosage of any medicines without your doctor's approval.||
2469|111|B|||
2469|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2469|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2469|114|O|poison control center right away. US residents can call||
2469|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2469|116|B|||
2469|117|N|NOTES:  Lab and/or medical tests (such as urine tests,||
2469|118|N|immunoglobulin levels) should be done while you are using this||
2469|119|N|medication. Keep all medical and lab appointments.||
2469|120|B|||
2469|121|D|MISSED DOSE:  It is important to get each dose of this medication||
2469|122|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2469|123|D|right away for a new dosing schedule.||
2469|124|B|||
2469|125|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2469|126|R|doctor's office and will not be stored at home.||
2469|127|B|||
2469|128|A|Information last revised October 2024.||
2469|129|A|Copyright(c) 2025 First Databank, Inc.||
2469|130|B|||
2470|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2470|002|Z|does NOT have all possible information about this product. This||
2470|003|Z|information does not assure that this product is safe, effective,||
2470|004|Z|or appropriate for you. This information is not individual||
2470|005|Z|medical advice and does not substitute for the advice of your||
2470|006|Z|health care professional. Always ask your health care||
2470|007|Z|professional for complete information about this product and your||
2470|008|Z|specific health needs.||
2470|009|B|||
2470|010|T|LARONIDASE - INJECTION||
2470|011|F|(lar-ON-i-dase)||
2470|012|B|||
2470|013|C|COMMON BRAND NAME(S):  Aldurazyme||
2470|014|B|||
2470|015|W|WARNING:  Laronidase can rarely cause a very serious (sometimes||
2470|016|W|fatal) allergic reaction. This reaction may occur during or up to||
2470|017|W|3 hours after the infusion. Get medical help right away if you||
2470|018|W|notice any symptoms of a serious allergic reaction, including:||
2470|019|W|itching/swelling (especially of the face/tongue/throat), trouble||
2470|020|W|breathing, severe dizziness, fainting, or rash/hives. Your health||
2470|021|W|care professional will monitor you closely for any signs of||
2470|022|W|allergic reactions during your infusion and for some time after.||
2470|023|W|   Before you start your infusion, tell your doctor if you have a||
2470|024|W|fever or an infection (such as cold or flu) or if you have a||
2470|025|W|history of heart problems (such as heart failure), breathing||
2470|026|W|problems, interrupted breathing during sleep (such as sleep||
2470|027|W|apnea), or swelling.||
2470|028|B|||
2470|029|U|USES:  Laronidase is used to treat a certain rare genetic problem||
2470|030|U|(mucopolysaccharidosis-MPS I). It works by replacing a certain||
2470|031|U|natural substance (lysosomal enzyme) that is missing in people||
2470|032|U|with this genetic problem. This medication improves lung function||
2470|033|U|and how far you can walk. Laronidase is not a cure and treatment||
2470|034|U|must be continued for life.||
2470|035|B|||
2470|036|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2470|037|H|from your pharmacist before you start using laronidase and each||
2470|038|H|time you get a refill. If you have any questions, ask your doctor||
2470|039|H|or pharmacist.||
2470|040|H|   This medication is given by injection into a vein as directed||
2470|041|H|by your doctor, usually every week. The injection is given by a||
2470|042|H|health care professional, usually over 3 to 4 hours. The dosage||
2470|043|H|is based on your medical condition, weight, and response to||
2470|044|H|treatment.||
2470|045|H|   Infusion reactions may happen during the infusion of this||
2470|046|H|drug. Your doctor may prescribe other medications 60 minutes||
2470|047|H|before each treatment to help prevent these side effects. Tell||
2470|048|H|your doctor right away if you have any symptoms of infusion||
2470|049|H|reactions such as flushing, fever, headache, or abdominal pain.||
2470|050|H|Your doctor may slow down or stop your treatment for some time.||
2470|051|H|See also Warning section.||
2470|052|H|   Use this medication regularly to get the most benefit from it.||
2470|053|H|To help you remember, mark your calendar with a reminder.||
2470|054|H|   Tell your doctor if your condition gets worse.||
2470|055|B|||
2470|056|S|SIDE EFFECTS:  See also How to Use section and Warning section.||
2470|057|S|   Cold symptoms (such as stuffy/runny nose, cough) may occur. If||
2470|058|S|any of these effects last or get worse, tell your doctor or||
2470|059|S|pharmacist promptly.||
2470|060|S|   Remember that this medication has been prescribed because your||
2470|061|S|doctor has judged that the benefit to you is greater than the||
2470|062|S|risk of side effects. Many people using this medication do not||
2470|063|S|have serious side effects.||
2470|064|S|   This is not a complete list of possible side effects. If you||
2470|065|S|notice other effects not listed above, contact your doctor or||
2470|066|S|pharmacist.||
2470|067|S|   In the US -||
2470|068|S|   Call your doctor for medical advice about side effects. You||
2470|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2470|070|S|www.fda.gov/medwatch.||
2470|071|S|   In Canada - Call your doctor for medical advice about side||
2470|072|S|effects. You may report side effects to Health Canada at||
2470|073|S|1-866-234-2345.||
2470|074|B|||
2470|075|P|PRECAUTIONS:  See Warning section.||
2470|076|P|   Before using laronidase, tell your doctor or pharmacist if you||
2470|077|P|are allergic to it; or if you have any other allergies. This||
2470|078|P|product may contain inactive ingredients, which can cause||
2470|079|P|allergic reactions or other problems. Talk to your pharmacist for||
2470|080|P|more details.||
2470|081|P|   Before using this medication, tell your doctor or pharmacist||
2470|082|P|your medical history.||
2470|083|P|   Before having surgery, tell your doctor or dentist about all||
2470|084|P|the products you use (including prescription drugs,||
2470|085|P|nonprescription drugs, and herbal products).||
2470|086|P|   During pregnancy, this medication should be used only when||
2470|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
2470|088|P|   It is unknown if this medication passes into breast milk.||
2470|089|P|Consult your doctor before breastfeeding.||
2470|090|B|||
2470|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2470|092|I|medications work or increase your risk for serious side effects.||
2470|093|I|This document does not contain all possible drug interactions.||
2470|094|I|Keep a list of all the products you use (including||
2470|095|I|prescription/nonprescription drugs and herbal products) and share||
2470|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
2470|097|I|the dosage of any medicines without your doctor's approval.||
2470|098|B|||
2470|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2470|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2470|101|O|poison control center right away. US residents can call||
2470|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2470|103|B|||
2470|104|N|NOTES:  Lab and/or medical tests (such as lung function, urine||
2470|105|N|tests, immunoglobulin levels) should be done before you start||
2470|106|N|using this medication and while you are using it. Keep all||
2470|107|N|medical and lab appointments. Consult your doctor for more||
2470|108|N|details.||
2470|109|B|||
2470|110|D|MISSED DOSE:  It is important to get each dose of this medication||
2470|111|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2470|112|D|right away for a new dosing schedule.||
2470|113|B|||
2470|114|R|STORAGE:  Not applicable. This medication is given in a hospital||
2470|115|R|or clinic and will not be stored at home.||
2470|116|B|||
2470|117|A|Information last revised October 2024.||
2470|118|A|Copyright(c) 2025 First Databank, Inc.||
2470|119|B|||
2471|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2471|002|Z|does NOT have all possible information about this product. This||
2471|003|Z|information does not assure that this product is safe, effective,||
2471|004|Z|or appropriate for you. This information is not individual||
2471|005|Z|medical advice and does not substitute for the advice of your||
2471|006|Z|health care professional. Always ask your health care||
2471|007|Z|professional for complete information about this product and your||
2471|008|Z|specific health needs.||
2471|009|B|||
2471|010|T|BUPROPION HCL EXTENDED-RELEASE (ANTIDEPRESSANT) - ORAL||
2471|011|F|(bue-PROE-pee-on HYE-droe-KLOR-ide)||
2471|012|B|||
2471|013|C|COMMON BRAND NAME(S): Wellbutrin XL||
2471|014|B|||
2471|015|W|WARNING:  Bupropion hydrochloride (HCL) is an antidepressant used||
2471|016|W|for smoking cessation and to treat a variety of conditions,||
2471|017|W|including depression and other mental/mood disorders.||
2471|018|W|Antidepressants can help prevent suicidal thoughts/attempts and||
2471|019|W|provide other important benefits. However, a small number of||
2471|020|W|people (especially people younger than 25) who take||
2471|021|W|antidepressants for any condition may experience new or worsening||
2471|022|W|depression, other mental/mood symptoms, or suicidal||
2471|023|W|thoughts/attempts. It is very important to talk with the doctor||
2471|024|W|about the risks and benefits of antidepressant medication, even||
2471|025|W|if treatment is not for a mental/mood condition.||
2471|026|W|   Tell the doctor right away if you notice new or worsening||
2471|027|W|depression/other psychiatric conditions, unusual behavior changes||
2471|028|W|(including possible suicidal thoughts/attempts), or other||
2471|029|W|mental/mood changes (including new/worsening anxiety, panic||
2471|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2471|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
2471|032|W|especially watchful for these symptoms when a new antidepressant||
2471|033|W|is started or when the dose is changed.||
2471|034|W|   If you are using bupropion to quit smoking and experience any||
2471|035|W|of these symptoms, stop taking it and contact your doctor right||
2471|036|W|away. Also, tell your doctor right away if you have any of these||
2471|037|W|symptoms after stopping treatment with bupropion.||
2471|038|B|||
2471|039|U|USES:  This medication is used to treat depression. It is also be||
2471|040|U|used to prevent seasonal affective disorder (SAD), a type of||
2471|041|U|depression that occurs each year at the same time (for example,||
2471|042|U|during winter). Bupropion works by helping to restore the balance||
2471|043|U|of certain natural substances (dopamine, norepinephrine) in the||
2471|044|U|brain.||
2471|045|B|||
2471|046|V|OTHER USES:  This section contains uses of this drug that are not||
2471|047|V|listed in the approved professional labeling for the drug but||
2471|048|V|that may be prescribed by your health care professional. Use this||
2471|049|V|drug for a condition that is listed in this section only if it||
2471|050|V|has been so prescribed by your health care professional.||
2471|051|V|   This drug may also be used for binge eating disorder (BED) or||
2471|052|V|other mental/mood disorders (such as attention deficit||
2471|053|V|hyperactivity disorder-ADHD, depressive phase of bipolar||
2471|054|V|disorder). It may also be used to help people quit smoking by||
2471|055|V|decreasing cravings and nicotine withdrawal effects.||
2471|056|B|||
2471|057|H|HOW TO USE:  Read the Medication Guide provided by your||
2471|058|H|pharmacist before you start using bupropion and each time you get||
2471|059|H|a refill. If you have any questions, ask your doctor or||
2471|060|H|pharmacist.||
2471|061|H|   Take this medication by mouth with or without food as directed||
2471|062|H|by your doctor, usually once daily in the morning. If you have||
2471|063|H|stomach upset, you may take this medication with or after a meal||
2471|064|H|or snack. Taking this medication late in the day may cause||
2471|065|H|trouble sleeping (insomnia). Take this medication regularly to||
2471|066|H|get the most benefit from it. To help you remember, take it at||
2471|067|H|the same time each day.||
2471|068|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
2471|069|H|Doing so can release all of the drug at once, increasing the risk||
2471|070|H|of side effects.||
2471|071|H|   The dosage is based on your medical condition and response to||
2471|072|H|treatment. To reduce your risk of side effects, your doctor may||
2471|073|H|direct you to start this medication at a low dose and gradually||
2471|074|H|increase your dose. Do not increase your dose or use this drug||
2471|075|H|more often or for longer than prescribed. Your condition will not||
2471|076|H|improve any faster, and your risk of side effects will increase.||
2471|077|H|   Do not stop taking this medication without consulting your||
2471|078|H|doctor. Your dose may need to be gradually decreased.||
2471|079|H|   It may take 4 weeks or longer before you get the full benefit||
2471|080|H|of this drug. Tell your doctor if your condition does not get||
2471|081|H|better or if it gets worse.||
2471|082|B|||
2471|083|S|SIDE EFFECTS:  See also Warning section.||
2471|084|S|   Dry mouth, sore throat, dizziness, nausea, vomiting, ringing||
2471|085|S|in the ears, headache, decreased appetite, weight loss,||
2471|086|S|constipation, trouble sleeping, increased sweating, or shaking||
2471|087|S|(tremor) may occur. If any of these effects last or get worse,||
2471|088|S|tell your doctor or pharmacist promptly.||
2471|089|S|   An empty tablet shell may appear in your stool. This effect is||
2471|090|S|harmless because your body has already absorbed the medication.||
2471|091|S|   Remember that this medication has been prescribed because your||
2471|092|S|doctor has judged that the benefit to you is greater than the||
2471|093|S|risk of side effects. Many people using this medication do not||
2471|094|S|have serious side effects.||
2471|095|S|   This medication may raise your blood pressure. Check your||
2471|096|S|blood pressure regularly and tell your doctor if the results are||
2471|097|S|high.||
2471|098|S|   Tell your doctor right away if you have any serious side||
2471|099|S|effects, including: fast/pounding/irregular heartbeat,||
2471|100|S|mental/mood changes (such as anxiety, agitation, confusion,||
2471|101|S|unusual behavior/thinking, memory loss), unusual weight loss or||
2471|102|S|gain.||
2471|103|S|   Get medical help right away if you have any very serious side||
2471|104|S|effects, including: seizure, eye pain/swelling/redness, widened||
2471|105|S|pupils, vision changes (such as seeing rainbows around lights at||
2471|106|S|night, blurred vision).||
2471|107|S|   A very serious allergic reaction to this drug is rare.||
2471|108|S|However, get medical help right away if you notice any symptoms||
2471|109|S|of a serious allergic reaction, including: rash, itching/swelling||
2471|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2471|111|S|breathing.||
2471|112|S|   This is not a complete list of possible side effects. If you||
2471|113|S|notice other effects not listed above, contact your doctor or||
2471|114|S|pharmacist.||
2471|115|S|   In the US -||
2471|116|S|   Call your doctor for medical advice about side effects. You||
2471|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2471|118|S|www.fda.gov/medwatch.||
2471|119|S|   In Canada - Call your doctor for medical advice about side||
2471|120|S|effects. You may report side effects to Health Canada at||
2471|121|S|1-866-234-2345.||
2471|122|B|||
2471|123|P|PRECAUTIONS:  Before taking bupropion, tell your doctor or||
2471|124|P|pharmacist if you are allergic to it; or if you have any other||
2471|125|P|allergies. This product may contain inactive ingredients, which||
2471|126|P|can cause allergic reactions or other problems. Talk to your||
2471|127|P|pharmacist for more details.||
2471|128|P|   Before using this medication, tell your doctor or pharmacist||
2471|129|P|your medical history, especially of: diabetes, heart disease,||
2471|130|P|high blood pressure, kidney problems, liver disease, use/abuse of||
2471|131|P|drugs/alcohol, seizures or conditions that increase your risk of||
2471|132|P|seizures (including brain/head injury, brain tumor, eating||
2471|133|P|disorders such as bulimia/anorexia nervosa), personal or family||
2471|134|P|history of glaucoma (angle-closure type).||
2471|135|P|   This medication should not be used if you are suddenly||
2471|136|P|stopping regular use of sedatives (including benzodiazepines such||
2471|137|P|as lorazepam), drugs used to treat seizures, or alcohol. Doing so||
2471|138|P|may increase your risk of seizures.||
2471|139|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2471|140|P|can make you more dizzy. Do not drive, use machinery, or do||
2471|141|P|anything that needs alertness until you can do it safely. Avoid||
2471|142|P|alcoholic beverages. Talk to your doctor if you are using||
2471|143|P|marijuana (cannabis). Alcohol can also increase your risk of||
2471|144|P|seizures.||
2471|145|P|   Before having surgery, tell your doctor or dentist about all||
2471|146|P|the products you use (including prescription drugs,||
2471|147|P|nonprescription drugs, and herbal products).||
2471|148|P|   Older adults may be more sensitive to the side effects of this||
2471|149|P|drug, especially dizziness and memory loss. Dizziness can||
2471|150|P|increase the risk of falling.||
2471|151|P|   During pregnancy, this medication should be used only when||
2471|152|P|clearly needed. Since untreated mental/mood problems (such as||
2471|153|P|depression, seasonal affective disorder, bipolar disorder) can be||
2471|154|P|a serious condition, do not stop taking this medication unless||
2471|155|P|directed by your doctor. If you are planning pregnancy, become||
2471|156|P|pregnant, or think you may be pregnant, immediately discuss with||
2471|157|P|your doctor the benefits and risks of using this medication||
2471|158|P|during pregnancy.||
2471|159|P|   This drug passes into breast milk and may have undesirable||
2471|160|P|effects on a nursing infant. Consult your doctor before||
2471|161|P|breastfeeding.||
2471|162|B|||
2471|163|I|DRUG INTERACTIONS:  See also Precautions section.||
2471|164|I|   Drug interactions may change how your medications work or||
2471|165|I|increase your risk for serious side effects. This document does||
2471|166|I|not contain all possible drug interactions. Keep a list of all||
2471|167|I|the products you use (including prescription/nonprescription||
2471|168|I|drugs and herbal products) and share it with your doctor and||
2471|169|I|pharmacist. Do not start, stop, or change the dosage of any||
2471|170|I|medicines without your doctor's approval.||
2471|171|I|   Some products that may interact with this drug are: codeine,||
2471|172|I|pimozide, tamoxifen, thioridazine.||
2471|173|I|   Taking MAO inhibitors with this medication may cause a serious||
2471|174|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2471|175|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2471|176|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2471|177|I|selegiline, tranylcypromine) during treatment with this||
2471|178|I|medication. Most MAO inhibitors should also not be taken for two||
2471|179|I|weeks before and after treatment with this medication. Ask your||
2471|180|I|doctor when to start or stop taking this medication.||
2471|181|I|   This medication may interfere with certain medical/lab tests||
2471|182|I|(such as brain scan for Parkinson's disease, urine screening for||
2471|183|I|amphetamines), possibly causing false test results. Make sure lab||
2471|184|I|personnel and all your doctors know you use this drug.||
2471|185|B|||
2471|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2471|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2471|188|O|poison control center right away. US residents can call||
2471|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2471|190|O|Symptoms of overdose may include: seizures, severe confusion,||
2471|191|O|hallucinations, rapid heart rate, loss of consciousness.||
2471|192|B|||
2471|193|N|NOTES:  Do not share this medication with others.||
2471|194|N|   Lab and/or medical tests (such as blood pressure, liver||
2471|195|N|function) may be done while you are taking this medication. Keep||
2471|196|N|all medical and lab appointments. Consult your doctor for more||
2471|197|N|details.||
2471|198|B|||
2471|199|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2471|200|D|next dose at the regular time. Do not double the dose to catch||
2471|201|D|up.||
2471|202|B|||
2471|203|R|STORAGE:  Store at room temperature away from light and moisture.||
2471|204|R|Do not store in the bathroom. Keep all medications away from||
2471|205|R|children and pets.||
2471|206|R|   Do not flush medications down the toilet or pour them into a||
2471|207|R|drain unless instructed to do so. Properly discard this product||
2471|208|R|when it is expired or no longer needed. Consult your pharmacist||
2471|209|R|or local waste disposal company.||
2471|210|B|||
2471|211|A|Information last revised November 2024.||
2471|212|A|Copyright(c) 2025 First Databank, Inc.||
2471|213|B|||
2472|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2472|002|Z|does NOT have all possible information about this product. This||
2472|003|Z|information does not assure that this product is safe, effective,||
2472|004|Z|or appropriate for you. This information is not individual||
2472|005|Z|medical advice and does not substitute for the advice of your||
2472|006|Z|health care professional. Always ask your health care||
2472|007|Z|professional for complete information about this product and your||
2472|008|Z|specific health needs.||
2472|009|B|||
2472|010|T|SPESOLIMAB - INJECTION||
2472|011|B|||
2472|012|C|COMMON BRAND NAME(S): Spevigo||
2472|013|B|||
2472|014|U|USES:  This medication is used to treat a severe form of||
2472|015|U|psoriasis (generalized pustular psoriasis). Spesolimab belongs to||
2472|016|U|a class of drugs known as monoclonal antibodies. It works by||
2472|017|U|blocking a certain natural protein in your body (interleukin-36)||
2472|018|U|that may cause inflammation and swelling.||
2472|019|B|||
2472|020|H|HOW TO USE:  Read the Medication Guide provided by your||
2472|021|H|pharmacist before you start using spesolimab and each time you||
2472|022|H|get a refill. If you have any questions, ask your doctor or||
2472|023|H|pharmacist.||
2472|024|H|   Before treatment with this medication, your doctor will test||
2472|025|H|you for tuberculosis (TB). Your doctor should also monitor you||
2472|026|H|for symptoms of TB during and after treatment with this drug. If||
2472|027|H|needed, treatment for TB or other infections should be given||
2472|028|H|before using this medication.||
2472|029|H|   This medication is given by injection into a vein as directed||
2472|030|H|by your doctor, usually as a single dose injected over 90||
2472|031|H|minutes. If your symptoms continue, your doctor may prescribe a||
2472|032|H|second dose, usually 1 week after the first dose. The dosage and||
2472|033|H|treatment schedule are based on your medical condition and||
2472|034|H|response to treatment.||
2472|035|H|   Infusion reactions may happen during the infusion of this||
2472|036|H|drug. Tell your doctor right away if you have any symptoms of||
2472|037|H|infusion reactions such as dizziness, lightheadedness, trouble||
2472|038|H|breathing, fever, chest tightness, or itching. Your doctor may||
2472|039|H|give you other medications to help with these side effects or may||
2472|040|H|slow down or stop your treatment for some time.||
2472|041|H|   Tell your doctor if your condition does not get better or if||
2472|042|H|it gets worse.||
2472|043|B|||
2472|044|S|SIDE EFFECTS:  Headache, nausea, vomiting, tiredness, or weakness||
2472|045|S|may occur. Pain, redness, swelling, or bruising at the injection||
2472|046|S|site may also occur. If any of these effects last or get worse,||
2472|047|S|tell your doctor or pharmacist promptly.||
2472|048|S|   Remember that this medication has been prescribed because your||
2472|049|S|doctor has judged that the benefit to you is greater than the||
2472|050|S|risk of side effects. Many people using this medication do not||
2472|051|S|have serious side effects.||
2472|052|S|   This medication may lower your ability to fight infections.||
2472|053|S|This may make you more likely to get a serious (rarely fatal)||
2472|054|S|infection or make any infection you have worse. Get medical help||
2472|055|S|right away if you have any signs of infection (such as sore||
2472|056|S|throat that doesn't go away, fever, swollen lymph nodes, chills).||
2472|057|S|   A very serious allergic reaction to this drug is rare.||
2472|058|S|However, get medical help right away if you notice any symptoms||
2472|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2472|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2472|061|S|breathing.||
2472|062|S|   This is not a complete list of possible side effects. If you||
2472|063|S|notice other effects not listed above, contact your doctor or||
2472|064|S|pharmacist.||
2472|065|S|   In the US -||
2472|066|S|   Call your doctor for medical advice about side effects. You||
2472|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2472|068|S|www.fda.gov/medwatch.||
2472|069|S|   In Canada - Call your doctor for medical advice about side||
2472|070|S|effects. You may report side effects to Health Canada at||
2472|071|S|1-866-234-2345.||
2472|072|B|||
2472|073|P|PRECAUTIONS:  Before using spesolimab, tell your doctor or||
2472|074|P|pharmacist if you are allergic to it; or if you have any other||
2472|075|P|allergies. This product may contain inactive ingredients which||
2472|076|P|can cause allergic reactions or other problems. Talk to your||
2472|077|P|pharmacist for more details.||
2472|078|P|   Before using this medication, tell your doctor or pharmacist||
2472|079|P|your medical history, especially of: current/recent/returning||
2472|080|P|infection (such as tuberculosis, herpes).||
2472|081|P|   Spesolimab can make you more likely to get infections or may||
2472|082|P|make current infections worse. Stay away from anyone who has an||
2472|083|P|infection that may easily spread (such as chickenpox, COVID-19,||
2472|084|P|measles, flu). Talk to your doctor if you have been exposed to an||
2472|085|P|infection or for more details.||
2472|086|P|   Tell your health care professional that you are using||
2472|087|P|spesolimab before having any immunizations/vaccinations. Avoid||
2472|088|P|getting a live vaccine while using this medication and for 16||
2472|089|P|weeks after the last dose. Avoid contact with people who have||
2472|090|P|recently received live vaccines (such as flu vaccine inhaled||
2472|091|P|through the nose).||
2472|092|P|   Before having surgery, tell your doctor or dentist about all||
2472|093|P|the products you use (including prescription drugs,||
2472|094|P|nonprescription drugs, and herbal products).||
2472|095|P|   During pregnancy, this medication should be used only when||
2472|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
2472|097|P|   It is unknown if this medication passes into breast milk.||
2472|098|P|Consult your doctor before breastfeeding.||
2472|099|B|||
2472|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2472|101|I|medications work or increase your risk for serious side effects.||
2472|102|I|This document does not contain all possible drug interactions.||
2472|103|I|Keep a list of all the products you use (including||
2472|104|I|prescription/nonprescription drugs and herbal products) and share||
2472|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
2472|106|I|the dosage of any medicines without your doctor's approval.||
2472|107|B|||
2472|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2472|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2472|110|O|poison control center right away. US residents can call||
2472|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2472|112|B|||
2472|113|N|NOTES:  Keep all medical and lab appointments.||
2472|114|B|||
2472|115|D|MISSED DOSE:  Not applicable.||
2472|116|B|||
2472|117|R|STORAGE:  Not applicable. This medication is given in a hospital||
2472|118|R|or clinic or doctor's office and will not be stored at home.||
2472|119|B|||
2472|120|A|Information last revised April 2025.||
2472|121|A|Copyright(c) 2025 First Databank, Inc.||
2472|122|B|||
2473|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2473|002|Z|does NOT have all possible information about this product. This||
2473|003|Z|information does not assure that this product is safe, effective,||
2473|004|Z|or appropriate for you. This information is not individual||
2473|005|Z|medical advice and does not substitute for the advice of your||
2473|006|Z|health care professional. Always ask your health care||
2473|007|Z|professional for complete information about this product and your||
2473|008|Z|specific health needs.||
2473|009|B|||
2473|010|T|PIRTOBRUTINIB - ORAL||
2473|011|B|||
2473|012|C|COMMON BRAND NAME(S): Jaypirca||
2473|013|B|||
2473|014|U|USES:  This medication is used to treat certain types of cancer||
2473|015|U|(such as mantle cell lymphoma-MCL, chronic lymphocytic||
2473|016|U|leukemia-CLL, small lymphocytic lymphoma-SLL). Pirtobrutinib||
2473|017|U|belongs to a class of drugs known as kinase inhibitors. It works||
2473|018|U|by slowing or stopping the growth of cancer cells.||
2473|019|B|||
2473|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2473|021|H|from your pharmacist before you start taking pirtobrutinib and||
2473|022|H|each time you get a refill. If you have any questions, ask your||
2473|023|H|doctor or pharmacist.||
2473|024|H|   Take this medication by mouth with or without food as directed||
2473|025|H|by your doctor, usually once daily. Swallow the tablets whole||
2473|026|H|with water. Do not split, crush, or chew the tablets.||
2473|027|H|   The dosage is based on your medical condition, response to||
2473|028|H|treatment, and other medications you may be taking. Be sure to||
2473|029|H|tell your doctor and pharmacist about all the products you use||
2473|030|H|(including prescription drugs, nonprescription drugs, and herbal||
2473|031|H|products).||
2473|032|H|   Use this medication regularly to get the most benefit from it.||
2473|033|H|To help you remember, take it at the same time each day.||
2473|034|H|   Do not increase your dose or use this drug more often or for||
2473|035|H|longer than prescribed. Your condition will not improve any||
2473|036|H|faster, and your risk of serious side effects will increase.||
2473|037|B|||
2473|038|S|SIDE EFFECTS:  Diarrhea, dizziness, muscle/joint pain, tiredness,||
2473|039|S|or swelling ankles/feet/hands may occur. If any of these effects||
2473|040|S|last or get worse, tell your doctor or pharmacist promptly.||
2473|041|S|   People using this medication may have serious side effects.||
2473|042|S|However, you have been prescribed this drug because your doctor||
2473|043|S|has judged that the benefit to you is greater than the risk of||
2473|044|S|side effects. Careful monitoring by your doctor may decrease your||
2473|045|S|risk.||
2473|046|S|   This medication may raise your blood pressure. Check your||
2473|047|S|blood pressure regularly and tell your doctor if the results are||
2473|048|S|high.||
2473|049|S|   Tell your doctor right away if you have any serious side||
2473|050|S|effects, including: easy bruising/bleeding, fast/irregular||
2473|051|S|heartbeat, signs of liver disease (such as nausea/vomiting that||
2473|052|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
2473|053|S|eyes/skin, dark urine).||
2473|054|S|   Get medical help right away if you have any very serious side||
2473|055|S|effects, including: coughing up blood, black/bloody stools, vomit||
2473|056|S|that looks like coffee grounds, pink/bloody urine, confusion,||
2473|057|S|severe headache, fainting, shortness of breath.||
2473|058|S|   This medication may increase the risk of other cancers||
2473|059|S|(especially skin cancer). Limit your time in the sun. Use||
2473|060|S|sunscreen and wear protective clothing when outdoors. Consult||
2473|061|S|your doctor for more details.||
2473|062|S|   This medication may lower your ability to fight infections.||
2473|063|S|This may make you more likely to get a serious (rarely fatal)||
2473|064|S|infection or make any infection you have worse. Tell your doctor||
2473|065|S|right away if you have any signs of infection (such as sore||
2473|066|S|throat that doesn't go away, fever, chills).||
2473|067|S|   A very serious allergic reaction to this drug is rare.||
2473|068|S|However, get medical help right away if you notice any symptoms||
2473|069|S|of a serious allergic reaction, including: rash, itching/swelling||
2473|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2473|071|S|breathing.||
2473|072|S|   This is not a complete list of possible side effects. If you||
2473|073|S|notice other effects not listed above, contact your doctor or||
2473|074|S|pharmacist.||
2473|075|S|   In the US -||
2473|076|S|   Call your doctor for medical advice about side effects. You||
2473|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2473|078|S|www.fda.gov/medwatch.||
2473|079|S|   In Canada - Call your doctor for medical advice about side||
2473|080|S|effects. You may report side effects to Health Canada at||
2473|081|S|1-866-234-2345.||
2473|082|B|||
2473|083|P|PRECAUTIONS:  Before taking pirtobrutinib, tell your doctor or||
2473|084|P|pharmacist if you are allergic to it; or if you have any other||
2473|085|P|allergies. This product may contain inactive ingredients, which||
2473|086|P|can cause allergic reactions or other problems. Talk to your||
2473|087|P|pharmacist for more details.||
2473|088|P|   Before using this medication, tell your doctor or pharmacist||
2473|089|P|your medical history, especially of: bleeding/blood problems,||
2473|090|P|heart problems (such as irregular heartbeat), high blood||
2473|091|P|pressure, kidney problems.||
2473|092|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2473|093|P|can make you more dizzy. Do not drive, use machinery, or do||
2473|094|P|anything that needs alertness until you can do it safely. Limit||
2473|095|P|alcoholic beverages. Talk to your doctor if you are using||
2473|096|P|marijuana(cannabis).||
2473|097|P|   Pirtobrutinib can make you more likely to get infections or||
2473|098|P|may make current infections worse. Stay away from anyone who has||
2473|099|P|an infection that may easily spread (such as chickenpox,||
2473|100|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2473|101|P|exposed to an infection or for more details.||
2473|102|P|   Tell your health care professional that you are using||
2473|103|P|pirtobrutinib before having any immunizations/vaccinations. Avoid||
2473|104|P|contact with people who have recently received live vaccines||
2473|105|P|(such as flu vaccine inhaled through the nose).||
2473|106|P|   To lower the chance of getting cut, bruised, or injured, use||
2473|107|P|caution with sharp objects like razors and nail cutters, and||
2473|108|P|avoid activities such as contact sports.||
2473|109|P|   Before having surgery, tell your doctor or dentist about all||
2473|110|P|the products you use (including prescription drugs,||
2473|111|P|nonprescription drugs, and herbal products). Your doctor may tell||
2473|112|P|you to temporarily stop treatment with this medication before||
2473|113|P|certain medical, surgical, or dental procedures.||
2473|114|P|   Tell your doctor if you are pregnant or plan to become||
2473|115|P|pregnant. You should not become pregnant while using||
2473|116|P|pirtobrutinib. Pirtobrutinib may harm an unborn baby. Your doctor||
2473|117|P|should order a pregnancy test before you start this medication.||
2473|118|P|Ask about reliable forms of birth control while using this||
2473|119|P|medication and for at least 1 week after the last dose. If you||
2473|120|P|become pregnant, talk to your doctor right away about the risks||
2473|121|P|and benefits of this medication.||
2473|122|P|   It is unknown if this drug passes into breast milk. Because of||
2473|123|P|the possible risk to the infant, breastfeeding is not recommended||
2473|124|P|while using this drug and for at least 1 week after the last||
2473|125|P|dose. Consult your doctor before breastfeeding.||
2473|126|B|||
2473|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2473|128|I|medications work or increase your risk for serious side effects.||
2473|129|I|This document does not contain all possible drug interactions.||
2473|130|I|Keep a list of all the products you use (including||
2473|131|I|prescription/nonprescription drugs and herbal products) and share||
2473|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
2473|133|I|the dosage of any medicines without your doctor's approval.||
2473|134|I|   Other medications can affect the removal of pirtobrutinib from||
2473|135|I|your body, which may affect how pirtobrutinib works. Examples||
2473|136|I|include rifamycins (such as rifampin, rifabutin), certain drugs||
2473|137|I|used to treat seizures (such as carbamazepine, phenytoin), St.||
2473|138|I|John's wort, among others.||
2473|139|I|   This medication can slow down the removal of other medications||
2473|140|I|from your body, which may affect how they work. Examples of||
2473|141|I|affected drugs include tovorafenib, among others.||
2473|142|B|||
2473|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2473|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2473|145|O|poison control center right away. US residents can call||
2473|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2473|147|B|||
2473|148|N|NOTES:  Do not share this medication with others.||
2473|149|N|   Lab and/or medical tests (such as complete blood count, liver||
2473|150|N|function, kidney function) should be done before you start taking||
2473|151|N|this medication and while you are taking it. Keep all medical and||
2473|152|N|lab appointments. Consult your doctor for more details.||
2473|153|B|||
2473|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2473|155|D|remember. If it is more than 12 hours after the missed dose, skip||
2473|156|D|the missed dose. Take your next dose at the regular time. Do not||
2473|157|D|double the dose to catch up.||
2473|158|B|||
2473|159|R|STORAGE:  Store at room temperature away from light and moisture.||
2473|160|R|Do not store in the bathroom. Keep all medications away from||
2473|161|R|children and pets.||
2473|162|R|   Do not flush medications down the toilet or pour them into a||
2473|163|R|drain unless instructed to do so. Properly discard this product||
2473|164|R|when it is expired or no longer needed. Consult your pharmacist||
2473|165|R|or local waste disposal company.||
2473|166|B|||
2473|167|M|MEDICAL ALERT:  Your condition can cause complications in a||
2473|168|M|medical emergency. For information about enrolling in MedicAlert,||
2473|169|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2473|170|B|||
2473|171|A|Information last revised April 2025.||
2473|172|A|Copyright(c) 2025 First Databank, Inc.||
2473|173|B|||
2474|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2474|002|Z|does NOT have all possible information about this product. This||
2474|003|Z|information does not assure that this product is safe, effective,||
2474|004|Z|or appropriate for you. This information is not individual||
2474|005|Z|medical advice and does not substitute for the advice of your||
2474|006|Z|health care professional. Always ask your health care||
2474|007|Z|professional for complete information about this product and your||
2474|008|Z|specific health needs.||
2474|009|B|||
2474|010|T|ELACESTRANT - ORAL||
2474|011|F|(EL-a-KES-trant)||
2474|012|B|||
2474|013|C|COMMON BRAND NAME(S): Orserdu||
2474|014|B|||
2474|015|U|USES:  Elacestrant is used to treat certain types of breast||
2474|016|U|cancer. Breast cancer cells need the hormone estrogen to grow.||
2474|017|U|Elacestrant works by blocking the effect of estrogen, slowing or||
2474|018|U|stopping the growth of cancer cells.||
2474|019|B|||
2474|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2474|021|H|from your pharmacist before you start taking elacestrant and each||
2474|022|H|time you get a refill. If you have any questions, ask your doctor||
2474|023|H|or pharmacist.||
2474|024|H|   Take this medication by mouth with food as directed by your||
2474|025|H|doctor, usually once daily. Swallow the tablets whole. Do not||
2474|026|H|chew, crush or split the tablets. Do not take tablets that are||
2474|027|H|broken. Taking elacestrant with food may help lessen nausea and||
2474|028|H|vomiting. If you vomit, do not take another dose to catch up.||
2474|029|H|Take your next dose at the regular time.||
2474|030|H|   The dosage is based on your medical condition and response to||
2474|031|H|treatment.||
2474|032|H|   Use this medication regularly to get the most benefit from it.||
2474|033|H|To help you remember, take it at the same time each day.||
2474|034|H|   Do not increase your dose or use this drug more often or for||
2474|035|H|longer than prescribed. Your condition will not improve any||
2474|036|H|faster, and your risk of serious side effects will increase.||
2474|037|H|   Since this drug can be absorbed through the skin and lungs,||
2474|038|H|women who are pregnant or who may become pregnant should not||
2474|039|H|handle this medication or breathe the dust from the tablets.||
2474|040|B|||
2474|041|S|SIDE EFFECTS:  Muscle/joint pain, tiredness, headache, flushing,||
2474|042|S|diarrhea, constipation, upset stomach, heartburn, nausea,||
2474|043|S|vomiting, or decreased appetite may occur. If any of these||
2474|044|S|effects last or get worse, tell your doctor or pharmacist||
2474|045|S|promptly.||
2474|046|S|   Remember that this medication has been prescribed because your||
2474|047|S|doctor has judged that the benefit to you is greater than the||
2474|048|S|risk of side effects. Many people using this medication do not||
2474|049|S|have serious side effects.||
2474|050|S|   A very serious allergic reaction to this drug is rare.||
2474|051|S|However, get medical help right away if you notice any symptoms||
2474|052|S|of a serious allergic reaction, including: rash, itching/swelling||
2474|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2474|054|S|breathing.||
2474|055|S|   This is not a complete list of possible side effects. If you||
2474|056|S|notice other effects not listed above, contact your doctor or||
2474|057|S|pharmacist.||
2474|058|S|   In the US -||
2474|059|S|   Call your doctor for medical advice about side effects. You||
2474|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2474|061|S|www.fda.gov/medwatch.||
2474|062|S|   In Canada - Call your doctor for medical advice about side||
2474|063|S|effects. You may report side effects to Health Canada at||
2474|064|S|1-866-234-2345.||
2474|065|B|||
2474|066|P|PRECAUTIONS:  Before taking elacestrant, tell your doctor or||
2474|067|P|pharmacist if you are allergic to it; or if you have any other||
2474|068|P|allergies. This product may contain inactive ingredients, which||
2474|069|P|can cause allergic reactions or other problems. Talk to your||
2474|070|P|pharmacist for more details.||
2474|071|P|   Before using this medication, tell your doctor or pharmacist||
2474|072|P|your medical history, especially of: liver disease.||
2474|073|P|   Before having surgery, tell your doctor or dentist about all||
2474|074|P|the products you use (including prescription drugs,||
2474|075|P|nonprescription drugs, and herbal products).||
2474|076|P|   Tell your doctor if you are pregnant or plan to become||
2474|077|P|pregnant. You should not become pregnant while using elacestrant.||
2474|078|P|Elacestrant may harm an unborn baby. Your doctor should order a||
2474|079|P|pregnancy test before you start this medication. Men and women||
2474|080|P|using this medication should ask about reliable forms of birth||
2474|081|P|control during treatment and for 1 week after the last dose. If||
2474|082|P|you or your partner becomes pregnant, talk to your doctor right||
2474|083|P|away about the risks and benefits of this medication.||
2474|084|P|   Since this drug can be absorbed through the skin and lungs and||
2474|085|P|may harm an unborn baby, women who are pregnant or who may become||
2474|086|P|pregnant should not handle this medication or breathe the dust||
2474|087|P|from the tablets.||
2474|088|P|   It is unknown if this medication passes into breast milk.||
2474|089|P|Because of the possible risk to the infant, breastfeeding is not||
2474|090|P|recommended while using this medication and for 1 week after the||
2474|091|P|last dose. Consult your doctor before breastfeeding.||
2474|092|B|||
2474|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2474|094|I|medications work or increase your risk for serious side effects.||
2474|095|I|This document does not contain all possible drug interactions.||
2474|096|I|Keep a list of all the products you use (including||
2474|097|I|prescription/nonprescription drugs and herbal products) and share||
2474|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
2474|099|I|the dosage of any medicines without your doctor's approval.||
2474|100|I|   Other medications can affect the removal of elacestrant from||
2474|101|I|your body, which may affect how elacestrant works. Examples||
2474|102|I|include azole antifungals (such as fluconazole, itraconazole),||
2474|103|I|cobicistat, certain HIV NNRTIs (such as efavirenz), HIV protease||
2474|104|I|inhibitors (such as atazanavir, darunavir), certain macrolide||
2474|105|I|antibiotics (such as clarithromycin, erythromycin), rifamycins||
2474|106|I|(such as rifampin), some drugs used to treat seizures (such as||
2474|107|I|carbamazepine, phenytoin), St. John's wort among others.||
2474|108|B|||
2474|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2474|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2474|111|O|poison control center right away. US residents can call||
2474|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2474|113|B|||
2474|114|N|NOTES:  Do not share this medication with others.||
2474|115|N|   Lab and/or medical tests (such as liver/kidney function,||
2474|116|N|cholesterol/triglyceride levels, complete blood counts) should be||
2474|117|N|done while you are using this medication. Keep all medical and||
2474|118|N|lab appointments. Consult your doctor for more details.||
2474|119|B|||
2474|120|D|MISSED DOSE:  It is important to get each dose of this medication||
2474|121|D|as scheduled. If you miss a dose, take it as soon as you||
2474|122|D|remember. If it is more than 6 hours after the missed dose, skip||
2474|123|D|the missed dose. Take your next dose at the regular time. Do not||
2474|124|D|double the dose to catch up.||
2474|125|B|||
2474|126|R|STORAGE:  Store at room temperature away from light and moisture.||
2474|127|R|Do not store in the bathroom. Keep all medications away from||
2474|128|R|children and pets.||
2474|129|R|   Do not flush medications down the toilet or pour them into a||
2474|130|R|drain unless instructed to do so. Properly discard this product||
2474|131|R|when it is expired or no longer needed. Consult your pharmacist||
2474|132|R|or local waste disposal company.||
2474|133|B|||
2474|134|A|Information last revised May 2024.||
2474|135|A|Copyright(c) 2025 First Databank, Inc.||
2474|136|B|||
2475|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2475|002|Z|does NOT have all possible information about this product. This||
2475|003|Z|information does not assure that this product is safe, effective,||
2475|004|Z|or appropriate for you. This information is not individual||
2475|005|Z|medical advice and does not substitute for the advice of your||
2475|006|Z|health care professional. Always ask your health care||
2475|007|Z|professional for complete information about this product and your||
2475|008|Z|specific health needs.||
2475|009|B|||
2475|010|T|DOCUSATE ENEMA - RECTAL||
2475|011|F|(DOCK-you-sate)||
2475|012|B|||
2475|013|C|COMMON BRAND NAME(S):  Enemeez, Docusol Kids||
2475|014|B|||
2475|015|U|USES:  This product is used to treat occasional constipation.||
2475|016|U|Docusate is a stool softener. It works by increasing the amount||
2475|017|U|of water the stool absorbs in the gut, making the stool softer||
2475|018|U|and easier to pass. This product usually results in a bowel||
2475|019|U|movement within 2 to 15 minutes.||
2475|020|U|   Check the ingredients on the label even if you have used the||
2475|021|U|product before. The manufacturer may have changed the||
2475|022|U|ingredients. Also, products with similar names may contain||
2475|023|U|different ingredients meant for different purposes. Using the||
2475|024|U|wrong product could harm you.||
2475|025|B|||
2475|026|H|HOW TO USE:  This product is for rectal use only. If you are||
2475|027|H|using the over-the-counter product to self-treat, read and follow||
2475|028|H|all directions on the product package before using this||
2475|029|H|medication. If you have any questions, consult your pharmacist.||
2475|030|H|If your doctor has prescribed this medication, use it as||
2475|031|H|directed.||
2475|032|H|   Wash your hands before and after using this product. Twist and||
2475|033|H|remove the tip. Lubricate the tip of the bottle and the rectum||
2475|034|H|with lubricant or the liquid before inserting. Lie on your left||
2475|035|H|side with knee bent. Instead, if you find it more comfortable,||
2475|036|H|you may kneel, then lower your head and chest forward until the||
2475|037|H|left side of the face is resting on a surface with your left arm||
2475|038|H|folded comfortably. You may also use it while seated on the||
2475|039|H|toilet. With steady pressure, gently insert enema tip into the||
2475|040|H|rectum up to the shoulder of the tube with a slight side-to-side||
2475|041|H|movement, pointing the tip toward the navel. Do not force the||
2475|042|H|enema tip into the rectum because doing so can cause injury.||
2475|043|H|Squeeze the tube until nearly all of the liquid is inside the||
2475|044|H|rectum. A small amount of liquid may remain in the tube after||
2475|045|H|use. Remove the single-use tube from the rectum and discard||
2475|046|H|properly.||
2475|047|H|   Use this medication only when needed. Do not use this product||
2475|048|H|for more than 1 week unless directed by your doctor.||
2475|049|H|   The dosage is based on your age, medical condition, and||
2475|050|H|response to treatment. Do not increase your dose or use this drug||
2475|051|H|more often or for longer than directed. Your condition will not||
2475|052|H|improve any faster, and your risk of side effects will increase.||
2475|053|H|   If your condition lasts or gets worse, or if you think you may||
2475|054|H|have a serious medical problem, get medical help right away.||
2475|055|B|||
2475|056|S|SIDE EFFECTS:  Rectal irritation/burning/itching may occur. If||
2475|057|S|any of these effects last or get worse, tell your doctor or||
2475|058|S|pharmacist promptly.||
2475|059|S|   If your doctor has directed you to use this medication,||
2475|060|S|remember that your doctor has judged that the benefit to you is||
2475|061|S|greater than the risk of side effects. Many people using this||
2475|062|S|medication do not have serious side effects.||
2475|063|S|   Tell your doctor right away if you have any serious side||
2475|064|S|effects, including: rectal bleeding.||
2475|065|S|   A very serious allergic reaction to this drug is rare.||
2475|066|S|However, get medical help right away if you notice any symptoms||
2475|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2475|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2475|069|S|breathing.||
2475|070|S|   This is not a complete list of possible side effects. If you||
2475|071|S|notice other effects not listed above, contact your doctor or||
2475|072|S|pharmacist.||
2475|073|S|   In the US -||
2475|074|S|   Call your doctor for medical advice about side effects. You||
2475|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2475|076|S|www.fda.gov/medwatch.||
2475|077|S|   In Canada - Call your doctor for medical advice about side||
2475|078|S|effects. You may report side effects to Health Canada at||
2475|079|S|1-866-234-2345.||
2475|080|B|||
2475|081|P|PRECAUTIONS:  Before using docusate, tell your doctor or||
2475|082|P|pharmacist if you are allergic to it; or if you have any other||
2475|083|P|allergies. This product may contain inactive ingredients, which||
2475|084|P|can cause allergic reactions or other problems. Talk to your||
2475|085|P|pharmacist for more details.||
2475|086|P|   If you have any of the following health problems, consult your||
2475|087|P|doctor or pharmacist before using this medication: rectal||
2475|088|P|bleeding, severe abdominal pain, nausea, vomiting, sudden change||
2475|089|P|in bowel habits over the previous 2 weeks.||
2475|090|P|   Before having surgery, tell your doctor or dentist about all||
2475|091|P|the products you use (including prescription drugs,||
2475|092|P|nonprescription drugs, and herbal products).||
2475|093|P|   Tell your doctor if you are pregnant before using this||
2475|094|P|medication.||
2475|095|P|   It is unknown if this drug passes into breast milk. Consult||
2475|096|P|your doctor before breastfeeding.||
2475|097|B|||
2475|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2475|099|I|medications work or increase your risk for serious side effects.||
2475|100|I|This document does not contain all possible drug interactions.||
2475|101|I|Keep a list of all the products you use (including||
2475|102|I|prescription/nonprescription drugs and herbal products) and share||
2475|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
2475|104|I|the dosage of any medicines without your doctor's approval.||
2475|105|I|   A product that may interact with this drug is: mineral oil.||
2475|106|B|||
2475|107|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2475|108|O|has overdosed and has serious symptoms such as passing out or||
2475|109|O|trouble breathing, call 911. Otherwise, call a poison control||
2475|110|O|center right away. US residents can call 1-800-222-1222. Canada||
2475|111|O|residents can call 1-844-764-7669.||
2475|112|B|||
2475|113|N|NOTES:  Keep all medical and lab appointments.||
2475|114|N|   To prevent constipation, eat dietary fiber, drink enough||
2475|115|N|water, and exercise. Use this medication for temporary relief of||
2475|116|N|constipation only. To prevent becoming dependent on laxatives, do||
2475|117|N|not use this medication for a long period of time.||
2475|118|B|||
2475|119|D|MISSED DOSE:  Not applicable.||
2475|120|B|||
2475|121|R|STORAGE:  Refer to storage information printed on the package. If||
2475|122|R|you have any questions about storage, ask your pharmacist. Keep||
2475|123|R|all medications away from children and pets.||
2475|124|R|   Do not flush medications down the toilet or pour them into a||
2475|125|R|drain unless instructed to do so. Properly discard this product||
2475|126|R|when it is expired or no longer needed. Consult your pharmacist||
2475|127|R|or local waste disposal company.||
2475|128|B|||
2475|129|A|Information last revised June 2025.||
2475|130|A|Copyright(c) 2025 First Databank, Inc.||
2475|131|B|||
2476|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2476|002|Z|does NOT have all possible information about this product. This||
2476|003|Z|information does not assure that this product is safe, effective,||
2476|004|Z|or appropriate for you. This information is not individual||
2476|005|Z|medical advice and does not substitute for the advice of your||
2476|006|Z|health care professional. Always ask your health care||
2476|007|Z|professional for complete information about this product and your||
2476|008|Z|specific health needs.||
2476|009|B|||
2476|010|T|NALOXONE SPRAY 8 MG - NASAL||
2476|011|F|(nal-OX-one)||
2476|012|B|||
2476|013|C|COMMON BRAND NAME(S): Kloxxado||
2476|014|B|||
2476|015|U|USES:  Naloxone is used for the emergency treatment of known or||
2476|016|U|suspected opioid overdose. Serious opioid overdose symptoms may||
2476|017|U|include unusual sleepiness, unusual difficulty waking up, or||
2476|018|U|breathing problems (ranging from slow/shallow breathing to no||
2476|019|U|breathing). Other symptoms of overdose may include very small||
2476|020|U|"pinpoint" pupils, slow heartbeat, or low blood pressure. If||
2476|021|U|someone has serious overdose symptoms but you are not sure if the||
2476|022|U|symptoms are due to opioid overdose, give naloxone right away||
2476|023|U|anyway, since lasting slow/shallow breathing may cause permanent||
2476|024|U|damage to the brain or death. Since symptoms of opioid overdose||
2476|025|U|may return after treatment, be sure to get medical help right||
2476|026|U|away after giving the first dose of naloxone.||
2476|027|U|   This medication belongs to a class of drugs known as opioid||
2476|028|U|antagonists. It works by blocking the effects of the opioid in||
2476|029|U|the brain.||
2476|030|B|||
2476|031|H|HOW TO USE:  Read the Patient Information Leaflet and||
2476|032|H|Instructions for Use provided by your pharmacist when you get||
2476|033|H|this medication and each time you get a refill. Be sure to keep||
2476|034|H|this medication handy in case it is needed. Learn ahead of time||
2476|035|H|how to properly give this medication. If you have any questions,||
2476|036|H|ask your doctor or pharmacist.||
2476|037|H|   Close family and household members should know the symptoms of||
2476|038|H|an opioid overdose and be instructed on how to give naloxone if||
2476|039|H|needed. Opioid overdose should be treated right away to prevent||
2476|040|H|serious effects (such as brain damage). See also Uses section.||
2476|041|H|   Remove the naloxone spray from the package only when you are||
2476|042|H|ready to use it. Lay the person on their back. Tilt the person's||
2476|043|H|head back and support their neck with your hand. Use your other||
2476|044|H|hand to gently insert the tip of the spray nozzle into one||
2476|045|H|nostril, then firmly press the plunger to give the dose. Remove||
2476|046|H|the spray nozzle from the nostril and move the person onto their||
2476|047|H|side as directed by the manufacturer.||
2476|048|H|   The effects of this medication are rapid but not long lasting.||
2476|049|H|After giving naloxone, get medical help right away, even if the||
2476|050|H|person wakes up. If symptoms return after giving the spray, give||
2476|051|H|another dose in the other nostril every 2 to 3 minutes, changing||
2476|052|H|nostrils with each dose. Each spray contains only one dose and||
2476|053|H|cannot be reused. Continue to closely watch the person until||
2476|054|H|emergency help comes. Tell the health care professional that you||
2476|055|H|have given naloxone spray.||
2476|056|B|||
2476|057|S|SIDE EFFECTS:  Nasal dryness, swelling, or stuffy nose may occur.||
2476|058|S|Muscle/joint pain or headache may also occur. If any of these||
2476|059|S|effects last or get worse, tell your doctor or pharmacist||
2476|060|S|promptly.||
2476|061|S|   Remember that this medication has been prescribed because your||
2476|062|S|doctor has judged that the benefit to you is greater than the||
2476|063|S|risk of side effects. Many people using this medication do not||
2476|064|S|have serious side effects.||
2476|065|S|   In someone who has been using an opioid regularly, withdrawal||
2476|066|S|symptoms can happen suddenly after receiving this medication.||
2476|067|S|Withdrawal symptoms may include body aches, fever, sweating,||
2476|068|S|watering eyes, runny nose, sneezing, goose bumps, yawning,||
2476|069|S|weakness, shivering/trembling, nervousness, restlessness,||
2476|070|S|diarrhea, nausea/vomiting, stomach cramps, increased blood||
2476|071|S|pressure, fast heartbeat. In babies younger than 4 weeks who have||
2476|072|S|been receiving an opioid regularly, sudden opioid withdrawal may||
2476|073|S|be life threatening if not treated the right way. Symptoms in||
2476|074|S|babies may include seizures, crying more than usual, and muscle||
2476|075|S|twitching/spasms.||
2476|076|S|   A very serious allergic reaction to this drug is rare.||
2476|077|S|However, get medical help right away if you notice any symptoms||
2476|078|S|of a serious allergic reaction, including: rash, itching/swelling||
2476|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2476|080|S|breathing.||
2476|081|S|   This is not a complete list of possible side effects. If you||
2476|082|S|notice other effects not listed above, contact your doctor or||
2476|083|S|pharmacist.||
2476|084|S|   In the US -||
2476|085|S|   Call your doctor for medical advice about side effects. You||
2476|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2476|087|S|www.fda.gov/medwatch.||
2476|088|S|   In Canada - Call your doctor for medical advice about side||
2476|089|S|effects. You may report side effects to Health Canada at||
2476|090|S|1-866-234-2345.||
2476|091|B|||
2476|092|P|PRECAUTIONS:  Before using naloxone, tell your doctor or||
2476|093|P|pharmacist if you are allergic to it; or if you have any other||
2476|094|P|allergies. This product may contain inactive ingredients, which||
2476|095|P|can cause allergic reactions or other problems. Talk to your||
2476|096|P|pharmacist for more details.||
2476|097|P|   Before using this medication, tell your doctor or pharmacist||
2476|098|P|your medical history, especially of: heart problems (such as||
2476|099|P|irregular heartbeat, previous heart attack).||
2476|100|P|   Before having surgery, tell your doctor or dentist about all||
2476|101|P|the products you use (including prescription drugs,||
2476|102|P|nonprescription drugs, and herbal products).||
2476|103|P|   Since untreated opioid overdose can harm both a pregnant woman||
2476|104|P|and her unborn baby, this medication may be used during||
2476|105|P|pregnancy. However, naloxone may cause opioid withdrawal in your||
2476|106|P|unborn baby. Tell your doctor right away that you used this||
2476|107|P|medication, so you and your unborn baby can be monitored. Ask||
2476|108|P|your doctor for details.||
2476|109|P|   It is unknown if this medication passes into breast milk.||
2476|110|P|However, it is unlikely to harm a nursing infant. Consult your||
2476|111|P|doctor before breastfeeding.||
2476|112|B|||
2476|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2476|114|I|medications work or increase your risk for serious side effects.||
2476|115|I|This document does not contain all possible drug interactions.||
2476|116|I|Keep a list of all the products you use (including||
2476|117|I|prescription/nonprescription drugs and herbal products) and share||
2476|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
2476|119|I|the dosage of any medicines without your doctor's approval.||
2476|120|B|||
2476|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2476|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2476|123|O|poison control center right away. US residents can call||
2476|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2476|125|B|||
2476|126|N|NOTES:  Ask your doctor or pharmacist about ways to prevent||
2476|127|N|opioid overdose. Teach your close family or household members the||
2476|128|N|signs and symptoms of an opioid overdose and tell them where you||
2476|129|N|keep this medication.||
2476|130|B|||
2476|131|D|MISSED DOSE:  Not applicable.||
2476|132|B|||
2476|133|R|STORAGE:  Store in the original carton at room temperature away||
2476|134|R|from light. Do not freeze. Do not open packaging until you are||
2476|135|R|ready to use the medication. From time to time, check the||
2476|136|R|expiration date and replace the medication before it expires.||
2476|137|R|Keep all medications away from children and pets.||
2476|138|R|   Do not flush medications down the toilet or pour them into a||
2476|139|R|drain unless instructed to do so. Properly discard this||
2476|140|R|medication when it is expired or no longer needed. Consult your||
2476|141|R|pharmacist or local waste disposal company.||
2476|142|B|||
2476|143|A|Information last revised September 2025.||
2476|144|A|Copyright(c) 2025 First Databank, Inc.||
2476|145|B|||
2477|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2477|002|Z|does NOT have all possible information about this product. This||
2477|003|Z|information does not assure that this product is safe, effective,||
2477|004|Z|or appropriate for you. This information is not individual||
2477|005|Z|medical advice and does not substitute for the advice of your||
2477|006|Z|health care professional. Always ask your health care||
2477|007|Z|professional for complete information about this product and your||
2477|008|Z|specific health needs.||
2477|009|B|||
2477|010|T|DABIGATRAN PELLETS - ORAL||
2477|011|F|(DA-bi-GAT-ran)||
2477|012|B|||
2477|013|C|COMMON BRAND NAME(S): Pradaxa||
2477|014|B|||
2477|015|W|WARNING:  Do not stop dabigatran unless directed by your child's||
2477|016|W|doctor. If you stop giving this medication early, your child has||
2477|017|W|a higher risk of forming a serious blood clot (such as stroke,||
2477|018|W|blood clot in the legs/lungs). The doctor may direct your child||
2477|019|W|to take a different "blood thinning" or antiplatelet medication||
2477|020|W|to reduce your child's risk. Get medical help right away if your||
2477|021|W|child has weakness on one side of the body, trouble speaking,||
2477|022|W|sudden vision changes, confusion, chest pain, trouble breathing,||
2477|023|W|or pain/warmth/swelling in the legs.||
2477|024|W|   People taking this medication may bleed near the spinal cord||
2477|025|W|after certain spinal procedures. Bleeding in this area can cause||
2477|026|W|paralysis that lasts a long time or could become permanent.||
2477|027|W|Before any spinal procedure, ask the doctor about the benefits||
2477|028|W|and risks. The risk of bleeding may be higher if your child has a||
2477|029|W|deformed spine, or has had spinal procedures/surgery before (such||
2477|030|W|as epidural catheter placement, difficult epidural/spinal||
2477|031|W|puncture), or if your child is taking other drugs that can cause||
2477|032|W|bleeding/bruising (including antiplatelet drugs such as||
2477|033|W|clopidogrel, "blood thinners" such as warfarin/enoxaparin,||
2477|034|W|nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen).||
2477|035|W|Tell the doctor right away if you notice symptoms such as back||
2477|036|W|pain, leg numbness/tingling/weakness, loss of control of the||
2477|037|W|bowels or bladder (incontinence).||
2477|038|B|||
2477|039|U|USES:  This form of dabigatran is given to infants and children||
2477|040|U|to treat blood clots in the veins of the legs (deep vein||
2477|041|U|thrombosis) or lungs (pulmonary embolism) and to reduce the risk||
2477|042|U|of them occurring again. Dabigatran is an anticoagulant that||
2477|043|U|works by blocking certain clotting proteins in the blood. This||
2477|044|U|helps to keep blood flowing smoothly in your child's body.||
2477|045|U|   Dabigatran should not be used to prevent blood clots from||
2477|046|U|forming after artificial heart valve replacement. If your child||
2477|047|U|had heart valve surgery, talk to the doctor about the best||
2477|048|U|medication for your child.||
2477|049|B|||
2477|050|H|HOW TO USE:  See also Warning section.||
2477|051|H|   Read the Medication Guide and, if available, the Instructions||
2477|052|H|for Use provided by the pharmacist before your child starts||
2477|053|H|dabigatran and each time you get a refill. If you have any||
2477|054|H|questions, ask the doctor or pharmacist.||
2477|055|H|   This medication is taken by mouth with or without food as||
2477|056|H|directed by the doctor, usually twice daily. For the best effect,||
2477|057|H|give this medication about 12 hours apart (first dose in the||
2477|058|H|morning and second dose in the evening). To help you remember,||
2477|059|H|give this medication at the same times every day.||
2477|060|H|   The dosage is based on your child's medical condition, age,||
2477|061|H|weight, response to treatment, and other medications your child||
2477|062|H|may be taking. Be sure to tell the doctor and pharmacist about||
2477|063|H|all the products your child uses (including prescription drugs,||
2477|064|H|nonprescription drugs, and herbal products).||
2477|065|H|   To give this medication without food, open the packet and||
2477|066|H|spoon the contents into your child's mouth. Offer apple juice as||
2477|067|H|needed to ensure the entire dose is swallowed. Pellets can also||
2477|068|H|be mixed in a cup with a small amount of apple juice (such as 1||
2477|069|H|to 2 ounces/30 to 60 milliliters). If any pellets remain in the||
2477|070|H|cup after drinking, add more apple juice to make sure the entire||
2477|071|H|dose is taken.||
2477|072|H|   If you are mixing the pellets with soft food, open the packet||
2477|073|H|and pour its contents into a small bowl with 2 teaspoons (10||
2477|074|H|milliliters) of certain soft foods (mashed carrots/banana or||
2477|075|H|applesauce). The soft food should be at or below room||
2477|076|H|temperature. Mix well with a spoon and give all of the mixture||
2477|077|H|right away.||
2477|078|H|   Repeat these steps if the dose is for more than one packet. Do||
2477|079|H|not give/mix with milk or milk products. Discard mixture after 30||
2477|080|H|minutes and do not save for later use. Do not prepare a supply in||
2477|081|H|advance. Do not give using a syringe or feeding tube. If only||
2477|082|H|part of the dose is taken, do not give another dose to catch up.||
2477|083|H|Give the next dose at the regular time. Giving the medication||
2477|084|H|before meals/feedings may help make sure your child will take the||
2477|085|H|entire dose.||
2477|086|H|   It is very important to give it exactly as directed. Do not||
2477|087|H|increase the dose or give this drug more often or for longer than||
2477|088|H|prescribed. Your child's condition will not improve any faster,||
2477|089|H|and the risk of serious side effects will increase.||
2477|090|B|||
2477|091|S|SIDE EFFECTS:  See also Warning section.||
2477|092|S|   Easy bruising, minor bleeding (such as nosebleed, bleeding||
2477|093|S|from cuts), diarrhea, upset stomach, or heartburn may occur. If||
2477|094|S|any of these effects last or get worse, tell the doctor or||
2477|095|S|pharmacist promptly.||
2477|096|S|   Remember that this medication has been prescribed because the||
2477|097|S|doctor has judged that the benefit to your child is greater than||
2477|098|S|the risk of side effects. Many people using this medication do||
2477|099|S|not have serious side effects.||
2477|100|S|   This medication can cause serious bleeding if it affects the||
2477|101|S|blood clotting proteins too much. Tell the doctor right away if||
2477|102|S|your child has any signs of serious bleeding, including:||
2477|103|S|nosebleeds that happen often or don't stop, unusual||
2477|104|S|tiredness/weakness, unusual pain/swelling/discomfort,||
2477|105|S|unusual/easy bruising, prolonged bleeding from cuts or gums,||
2477|106|S|unusually heavy/prolonged menstrual flow, pink/dark urine,||
2477|107|S|coughing up blood, vomit that is bloody or looks like coffee||
2477|108|S|grounds, severe headache, dizziness/fainting, bloody/black/tarry||
2477|109|S|stools.||
2477|110|S|   Get medical help right away if your child has any signs of||
2477|111|S|very serious bleeding, including: vision changes, confusion,||
2477|112|S|trouble speaking, weakness on one side of the body.||
2477|113|S|   A very serious allergic reaction to this drug is rare.||
2477|114|S|However, get medical help right away if you notice any symptoms||
2477|115|S|of a serious allergic reaction, including: rash, itching/swelling||
2477|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2477|117|S|breathing.||
2477|118|S|   This is not a complete list of possible side effects. If you||
2477|119|S|notice other effects not listed above, contact the doctor or||
2477|120|S|pharmacist.||
2477|121|S|   In the US -||
2477|122|S|   Call the doctor for medical advice about side effects. You may||
2477|123|S|report side effects to FDA at 1-800-FDA-1088 or at||
2477|124|S|www.fda.gov/medwatch.||
2477|125|S|   In Canada - Call the doctor for medical advice about side||
2477|126|S|effects. You may report side effects to Health Canada at||
2477|127|S|1-866-234-2345.||
2477|128|B|||
2477|129|P|PRECAUTIONS:  Before giving dabigatran, tell the doctor or||
2477|130|P|pharmacist if your child is allergic to it; or if your child has||
2477|131|P|any other allergies. This product may contain inactive||
2477|132|P|ingredients, which can cause allergic reactions or other||
2477|133|P|problems. Talk to the pharmacist for more details.||
2477|134|P|   Before using this medication, tell the doctor or pharmacist||
2477|135|P|your child's medical history, especially of: mechanical heart||
2477|136|P|valve, kidney disease, bleeding problems (such as bleeding of the||
2477|137|P|stomach/intestines, bleeding in the brain), blood disorders (such||
2477|138|P|as anemia, hemophilia, thrombocytopenia), liver disease, recent||
2477|139|P|major injury/surgery, stroke, a certain clotting disorder||
2477|140|P|(antiphospholipid syndrome), frequent falls/injuries.||
2477|141|P|   Before your child has surgery or any medical/dental procedures||
2477|142|P|(especially spinal puncture or spinal/epidural anesthesia), tell||
2477|143|P|the doctor or dentist that your child is taking this medication||
2477|144|P|and about all the products your child uses (including||
2477|145|P|prescription drugs, nonprescription drugs, and herbal products).||
2477|146|P|The doctor or dentist may tell you to stop giving dabigatran||
2477|147|P|before your surgery. Ask for specific instructions about stopping||
2477|148|P|or starting this medication.||
2477|149|P|   This medication may cause stomach bleeding. Daily use of||
2477|150|P|alcohol while using this medicine may increase the risk for||
2477|151|P|stomach bleeding. Avoid alcoholic beverages.||
2477|152|P|   This medication can cause heavy bleeding. To lower the chance||
2477|153|P|of getting cut, bruised, or injured, use caution with sharp||
2477|154|P|objects like razors and nail cutters, and avoid activities such||
2477|155|P|as contact sports. Your child should use an electric razor when||
2477|156|P|shaving and a soft toothbrush when brushing their teeth. If your||
2477|157|P|child falls or is injured, especially if your child hits their||
2477|158|P|head, call the doctor right away. The doctor may need to check||
2477|159|P|your child.||
2477|160|P|   This form of dabigatran is not usually used by adults. It is||
2477|161|P|unlikely to be used during pregnancy or breastfeeding. Consult||
2477|162|P|the doctor if you have any questions about this medication.||
2477|163|B|||
2477|164|I|DRUG INTERACTIONS:  See also Warning section.||
2477|165|I|   Drug interactions may change how your medications work or||
2477|166|I|increase your risk for serious side effects. This document does||
2477|167|I|not contain all possible drug interactions. Keep a list of all||
2477|168|I|the products you use (including prescription/nonprescription||
2477|169|I|drugs and herbal products) and share it with your doctor and||
2477|170|I|pharmacist. Do not start, stop, or change the dosage of any||
2477|171|I|medicines without your doctor's approval.||
2477|172|I|   Some products that may interact with this drug are:||
2477|173|I|mifepristone, other drugs that can cause bleeding/bruising||
2477|174|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
2477|175|I|ibuprofen/naproxen, "blood thinners" such as warfarin/apixaban).||
2477|176|I|   Aspirin can increase the risk of bleeding when used with this||
2477|177|I|medication. However, if the doctor has told you to give aspirin,||
2477|178|I|your child should keep taking the aspirin unless the doctor tells||
2477|179|I|you not to. Ask the doctor or pharmacist for more details.||
2477|180|I|   Other medications can affect the removal of dabigatran from||
2477|181|I|the body, which may affect how dabigatran works. Examples include||
2477|182|I|apalutamide, cobicistat, cyclosporine, dronedarone, ketoconazole,||
2477|183|I|lorlatinib, rifampin, St. John's wort, drugs used to treat||
2477|184|I|seizures (such as carbamazepine, phenytoin), among others.||
2477|185|B|||
2477|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2477|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2477|188|O|poison control center right away. US residents can call||
2477|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2477|190|O|Symptoms of overdose may include: bloody/black/tarry stools,||
2477|191|O|pink/dark urine, unusual/prolonged bleeding.||
2477|192|B|||
2477|193|N|NOTES:  Do not share this medication with others.||
2477|194|N|   Lab and/or medical tests (such as kidney/liver function,||
2477|195|N|clotting times) may be done while your child is taking this||
2477|196|N|medication. Keep all medical and lab appointments. Consult the||
2477|197|N|doctor for more details.||
2477|198|B|||
2477|199|D|MISSED DOSE:  If your child misses a dose, give it as soon as you||
2477|200|D|remember. If it is less than 6 hours before the next dose, skip||
2477|201|D|the missed dose. Give the next dose at the regular time. Do not||
2477|202|D|double the dose to catch up.||
2477|203|B|||
2477|204|R|STORAGE:  Store at room temperature away from light and moisture.||
2477|205|R|Do not store in the bathroom. Keep the packets in the aluminum||
2477|206|R|bag until you are ready to give the medication. After opening the||
2477|207|R|aluminum bag, discard the desiccant found in the bag. Once the||
2477|208|R|aluminum bag is opened, this medication expires after 6 months.||
2477|209|R|Keep all medications away from children and pets.||
2477|210|R|   Do not flush medications down the toilet or pour them into a||
2477|211|R|drain unless instructed to do so. Properly discard this product||
2477|212|R|when it is expired or no longer needed. Consult your pharmacist||
2477|213|R|or local waste disposal company.||
2477|214|B|||
2477|215|M|MEDICAL ALERT:  Your child's condition can cause complications in||
2477|216|M|a medical emergency. For information about enrolling in||
2477|217|M|MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2477|218|B|||
2477|219|A|Information last revised July 2025.||
2477|220|A|Copyright(c) 2025 First Databank, Inc.||
2477|221|B|||
2478|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2478|002|Z|does NOT have all possible information about this product. This||
2478|003|Z|information does not assure that this product is safe, effective,||
2478|004|Z|or appropriate for you. This information is not individual||
2478|005|Z|medical advice and does not substitute for the advice of your||
2478|006|Z|health care professional. Always ask your health care||
2478|007|Z|professional for complete information about this product and your||
2478|008|Z|specific health needs.||
2478|009|B|||
2478|010|T|RACEPINEPHRINE - ORAL INHALATION||
2478|011|F|(RAYSE-ep-i-NEF-rin)||
2478|012|B|||
2478|013|C|COMMON BRAND NAME(S): Asthmanefrin||
2478|014|B|||
2478|015|U|USES:  Racepinephrine is used to treat wheezing and shortness of||
2478|016|U|breath caused by asthma. Controlling these symptoms can decrease||
2478|017|U|time lost from work or school. Racepinephrine belongs to a class||
2478|018|U|of drugs known as bronchodilators. It works by relaxing the||
2478|019|U|muscles around the airways so that they open up and you can||
2478|020|U|breathe more easily. Use this medication only if you have been||
2478|021|U|told by your doctor that you have asthma.||
2478|022|B|||
2478|023|H|HOW TO USE:  If you are using the over-the-counter product to||
2478|024|H|self-treat, read all directions on the product package before||
2478|025|H|using this medication. If you have any questions, consult your||
2478|026|H|pharmacist. If your doctor has prescribed this medication, use it||
2478|027|H|as directed.||
2478|028|H|   This product is used with a special breathing device (such as||
2478|029|H|an atomizer or nebulizer) that changes the solution to a fine||
2478|030|H|mist that you inhale. Do not swallow or inject the solution. Do||
2478|031|H|not mix with other medicines in your breathing device. Learn all||
2478|032|H|instructions for proper use of this medication and the device.||
2478|033|H|Make sure you understand how to properly clean the device to||
2478|034|H|prevent infections. If you have any questions, consult your||
2478|035|H|doctor, pharmacist, or respiratory therapist.||
2478|036|H|   Before using, check this product for cloudiness, particles, or||
2478|037|H|discoloration. If you see any of these things, do not use the||
2478|038|H|liquid.||
2478|039|H|   Inhale this medication into your lungs using the breathing||
2478|040|H|device usually every 3 hours as needed. If a child is using this||
2478|041|H|medication, an adult should supervise the child. Do not use again||
2478|042|H|for at least 3 hours. Do not use more than 12 vials in a 24-hour||
2478|043|H|period.||
2478|044|H|   Caffeine can increase the side effects of this medication.||
2478|045|H|Avoid drinking large amounts of beverages containing caffeine||
2478|046|H|(coffee, tea, colas), eating large amounts of chocolate, or||
2478|047|H|taking nonprescription products that contain caffeine.||
2478|048|H|   If your breathing does not get better within 20 minutes after||
2478|049|H|using this medication, if your breathing gets worse, or if you||
2478|050|H|think you may have a serious medical problem, get medical help||
2478|051|H|right away.||
2478|052|B|||
2478|053|S|SIDE EFFECTS:  Headache, dizziness, nausea, vomiting, trouble||
2478|054|S|sleeping, anxiety, nervousness, shakiness, sweating, or pale skin||
2478|055|S|may occur. If any of these effects last or get worse, tell your||
2478|056|S|doctor or pharmacist promptly.||
2478|057|S|   If your doctor has directed you to use this medication,||
2478|058|S|remember that your doctor has judged that the benefit to you is||
2478|059|S|greater than the risk of side effects. Many people using this||
2478|060|S|medication do not have serious side effects.||
2478|061|S|   This medication may raise your blood pressure. Check your||
2478|062|S|blood pressure regularly and tell your doctor if the results are||
2478|063|S|high.||
2478|064|S|   Tell your doctor right away if you have any serious side||
2478|065|S|effects, including: fast/pounding/irregular heartbeat,||
2478|066|S|mental/mood changes (such hallucinations).||
2478|067|S|   Rarely, this medication may cause severe (rarely fatal),||
2478|068|S|sudden worsening of breathing problems (rebound bronchospasm). If||
2478|069|S|you notice a sudden worsening of breathing/wheezing, get medical||
2478|070|S|help right away.||
2478|071|S|   A very serious allergic reaction to this drug is rare.||
2478|072|S|However, get medical help right away if you notice any symptoms||
2478|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2478|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2478|075|S|breathing.||
2478|076|S|   This is not a complete list of possible side effects. If you||
2478|077|S|notice other effects not listed above, contact your doctor or||
2478|078|S|pharmacist.||
2478|079|S|   In the US -||
2478|080|S|   Call your doctor for medical advice about side effects. You||
2478|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2478|082|S|www.fda.gov/medwatch.||
2478|083|S|   In Canada - Call your doctor for medical advice about side||
2478|084|S|effects. You may report side effects to Health Canada at||
2478|085|S|1-866-234-2345.||
2478|086|B|||
2478|087|P|PRECAUTIONS:  Before using racepinephrine, tell your doctor or||
2478|088|P|pharmacist if you are allergic to it; or to epinephrine; or if||
2478|089|P|you have any other allergies. This product may contain inactive||
2478|090|P|ingredients, which can cause allergic reactions or other||
2478|091|P|problems. Talk to your pharmacist for more details.||
2478|092|P|   If you have any of the following health problems, consult your||
2478|093|P|doctor or pharmacist before using this product: heart problems||
2478|094|P|(such as irregular heartbeat, high blood pressure), diabetes,||
2478|095|P|overactive thyroid, mental/mood disorders (such as depression),||
2478|096|P|Parkinson's disease, seizures, glaucoma (narrow angle), enlarged||
2478|097|P|prostate.||
2478|098|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2478|099|P|can make you more dizzy. Do not drive, use machinery, or do||
2478|100|P|anything that needs alertness until you can do it safely. Limit||
2478|101|P|alcoholic beverages. Talk to your doctor if you are using||
2478|102|P|marijuana (cannabis).||
2478|103|P|   Before having surgery, tell your doctor or dentist about all||
2478|104|P|the products you use (including prescription drugs,||
2478|105|P|nonprescription drugs, and herbal products).||
2478|106|P|   Older adults may be more sensitive to the side effects of this||
2478|107|P|drug, especially the effects on the heart.||
2478|108|P|   During pregnancy, this medication should be used only when||
2478|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
2478|110|P|   It is unknown if this drug passes into breast milk. Consult||
2478|111|P|your doctor before breastfeeding.||
2478|112|B|||
2478|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2478|114|I|medications work or increase your risk for serious side effects.||
2478|115|I|This document does not contain all possible drug interactions.||
2478|116|I|Keep a list of all the products you use (including||
2478|117|I|prescription/nonprescription drugs and herbal products) and share||
2478|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
2478|119|I|the dosage of any medicines without your doctor's approval.||
2478|120|I|   Some products that may interact with this drug are: some beta||
2478|121|I|blockers (such as propranolol).||
2478|122|I|   Taking MAO inhibitors with this medication may cause a serious||
2478|123|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
2478|124|I|(isocarboxazid, linezolid, methylene blue, moclobemide,||
2478|125|I|phenelzine, procarbazine, rasagiline, selegiline,||
2478|126|I|tranylcypromine) during treatment with this medication. Most MAO||
2478|127|I|inhibitors should also not be taken for two weeks before||
2478|128|I|treatment with this medication. Ask your doctor when to start or||
2478|129|I|stop using this medication.||
2478|130|B|||
2478|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2478|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2478|133|O|poison control center right away. US residents can call||
2478|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2478|135|B|||
2478|136|N|NOTES:  Lab and/or medical tests (such as blood pressure, heart||
2478|137|N|rate) should be done while you are using this medication. Keep||
2478|138|N|all medical and lab appointments. Consult your doctor for more||
2478|139|N|details.||
2478|140|N|   Avoid substances that can worsen breathing problems by causing||
2478|141|N|irritation or allergic reaction, such as smoke, pollen, pet||
2478|142|N|dander, dust, and mold.||
2478|143|N|   Learn to use a peak flow meter, use it daily, and promptly||
2478|144|N|report worsening breathing problems (such as readings in the||
2478|145|N|yellow/red range, increased use of quick-relief inhalers).||
2478|146|N|   Because the flu virus can worsen breathing problems, ask your||
2478|147|N|doctor or pharmacist if you should have a flu shot every year.||
2478|148|B|||
2478|149|D|MISSED DOSE:  Not applicable.||
2478|150|B|||
2478|151|R|STORAGE:  Store in the refrigerator or at room temperature away||
2478|152|R|from light. Keep the medication in the foil pouch until ready to||
2478|153|R|use. Do not freeze. Keep all medications away from children and||
2478|154|R|pets.||
2478|155|R|   Do not flush medications down the toilet or pour them into a||
2478|156|R|drain unless instructed to do so. Properly discard this product||
2478|157|R|when it is expired or no longer needed. Consult your pharmacist||
2478|158|R|or local waste disposal company.||
2478|159|B|||
2478|160|M|MEDICAL ALERT:  Your condition can cause complications in a||
2478|161|M|medical emergency. For information about enrolling in MedicAlert,||
2478|162|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2478|163|B|||
2478|164|A|Information last revised March 2025.||
2478|165|A|Copyright(c) 2025 First Databank, Inc.||
2478|166|B|||
2479|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2479|002|Z|does NOT have all possible information about this product. This||
2479|003|Z|information does not assure that this product is safe, effective,||
2479|004|Z|or appropriate for you. This information is not individual||
2479|005|Z|medical advice and does not substitute for the advice of your||
2479|006|Z|health care professional. Always ask your health care||
2479|007|Z|professional for complete information about this product and your||
2479|008|Z|specific health needs.||
2479|009|B|||
2479|010|T|BUROSUMAB - INJECTION||
2479|011|F|(bur-OH-sue-mab)||
2479|012|B|||
2479|013|C|COMMON BRAND NAME(S): Crysvita||
2479|014|B|||
2479|015|U|USES:  This medication is used to treat low phosphate levels||
2479|016|U|caused by a certain rare genetic problem (X-linked||
2479|017|U|hypophosphatemia) or by a tumor (tumor-induced osteomalacia). It||
2479|018|U|helps by reducing a hormone in your blood (fibroblast growth||
2479|019|U|factor 23) which increases phosphate levels in your body. Normal||
2479|020|U|phosphate levels are important for the growth and strength of||
2479|021|U|bones, teeth, and muscles. Burosumab belongs to a class of drugs||
2479|022|U|known as monoclonal antibodies.||
2479|023|B|||
2479|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2479|025|H|from your pharmacist before you start using burosumab and each||
2479|026|H|time you get an injection. If you have any questions, ask your||
2479|027|H|doctor or pharmacist.||
2479|028|H|   This medication is given by injection under the skin of the||
2479|029|H|abdomen, buttock, thigh, or upper arm by a health care||
2479|030|H|professional. It is given as directed by your doctor, usually||
2479|031|H|once every 2 or 4 weeks. The dosage is based on your medical||
2479|032|H|condition, weight, labs (such as phosphate levels), and response||
2479|033|H|to treatment.||
2479|034|H|   Your doctor will direct you to stop certain medications (such||
2479|035|H|as man-made forms of vitamin D and medications taken by mouth for||
2479|036|H|phosphate levels) 1 week before starting this medication. Consult||
2479|037|H|your doctor or pharmacist for more details.||
2479|038|H|   Use this medication regularly to get the most benefit from it.||
2479|039|H|To help you remember, mark your calendar with a reminder.||
2479|040|B|||
2479|041|S|SIDE EFFECTS:  Injection site redness, pain, itching, or swelling||
2479|042|S|may occur. Nausea, cough, dizziness, vomiting, headache, muscle||
2479|043|S|pain, or diarrhea may also occur. If any of these effects last or||
2479|044|S|get worse, tell your doctor or pharmacist promptly.||
2479|045|S|   Remember that this medication has been prescribed because your||
2479|046|S|doctor has judged that the benefit to you is greater than the||
2479|047|S|risk of side effects. Many people using this medication do not||
2479|048|S|have serious side effects.||
2479|049|S|   Tell your doctor right away if you have any serious side||
2479|050|S|effects, including: symptoms of high phosphate levels (such as||
2479|051|S|muscle cramps or numbness around the mouth), symptoms of tooth||
2479|052|S|infections (such as tooth pain, swelling).||
2479|053|S|   This medication may rarely cause high calcium levels in the||
2479|054|S|blood. You may be at an increased risk for high calcium levels if||
2479|055|S|you have a certain hormone problem (hyperparathyroidism), if you||
2479|056|S|are immobile (such as on very long plane flights or being||
2479|057|S|bedridden), are dehydrated, or have higher levels of vitamin D.||
2479|058|S|Tell your doctor right away if you have symptoms of high calcium||
2479|059|S|levels such as unusual tiredness, mental/mood changes, or||
2479|060|S|constipation.||
2479|061|S|   This medication can worsen or cause a certain medical||
2479|062|S|condition (restless legs syndrome-RLS). Tell your doctor right||
2479|063|S|away if you have symptoms of restless legs syndrome such as an||
2479|064|S|unusual urge to move your legs or an uncomfortable/unpleasant||
2479|065|S|feeling in the legs usually at night.||
2479|066|S|   A very serious allergic reaction to this drug is rare.||
2479|067|S|However, get medical help right away if you notice any symptoms||
2479|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2479|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2479|070|S|breathing.||
2479|071|S|   This is not a complete list of possible side effects. If you||
2479|072|S|notice other effects not listed above, contact your doctor or||
2479|073|S|pharmacist.||
2479|074|S|   In the US -||
2479|075|S|   Call your doctor for medical advice about side effects. You||
2479|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2479|077|S|www.fda.gov/medwatch.||
2479|078|S|   In Canada - Call your doctor for medical advice about side||
2479|079|S|effects. You may report side effects to Health Canada at||
2479|080|S|1-866-234-2345.||
2479|081|B|||
2479|082|P|PRECAUTIONS:  See also Side Effects section.||
2479|083|P|   Before using burosumab, tell your doctor or pharmacist if you||
2479|084|P|are allergic to it; or if you have any other allergies. This||
2479|085|P|product may contain inactive ingredients, which can cause||
2479|086|P|allergic reactions or other problems. Talk to your pharmacist for||
2479|087|P|more details.||
2479|088|P|   Before using this medication, tell your doctor or pharmacist||
2479|089|P|your medical history, especially of: kidney disease, high levels||
2479|090|P|of phosphate/calcium in your blood.||
2479|091|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2479|092|P|can make you more dizzy. Do not drive, use machinery, or do||
2479|093|P|anything that needs alertness until you can do it safely. Limit||
2479|094|P|alcoholic beverages. Talk to your doctor if you are using||
2479|095|P|marijuana (cannabis).||
2479|096|P|   Before having surgery, tell your doctor or dentist about all||
2479|097|P|the products you use (including prescription drugs,||
2479|098|P|nonprescription drugs, and herbal products).||
2479|099|P|   During pregnancy, burosumab should be used only when clearly||
2479|100|P|needed. It may harm an unborn baby. Discuss the risks and||
2479|101|P|benefits with your doctor.||
2479|102|P|   It is unknown if this medication passes into breast milk.||
2479|103|P|Consult your doctor before breastfeeding.||
2479|104|B|||
2479|105|I|DRUG INTERACTIONS:  See also How to Use section.||
2479|106|I|   Drug interactions may change how your medications work or||
2479|107|I|increase your risk for serious side effects. This document does||
2479|108|I|not contain all possible drug interactions. Keep a list of all||
2479|109|I|the products you use (including prescription/nonprescription||
2479|110|I|drugs and herbal products) and share it with your doctor and||
2479|111|I|pharmacist. Do not start, stop, or change the dosage of any||
2479|112|I|medicines without your doctor's approval.||
2479|113|I|   Some products that may interact with this drug are: certain||
2479|114|I|medications that increase phosphate levels (such as potassium||
2479|115|I|phosphate, sodium phosphate), certain man-made active forms of||
2479|116|I|vitamin D drugs (such as calcifediol, calcitriol,||
2479|117|I|doxercalciferol, paricalcitol).||
2479|118|B|||
2479|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2479|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2479|121|O|poison control center right away. US residents can call||
2479|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2479|123|B|||
2479|124|N|NOTES:  Lab and/or medical tests (such as phosphate levels,||
2479|125|N|vitamin D levels, kidney function, calcium levels, parathyroid||
2479|126|N|hormone levels) should be done before you start using this||
2479|127|N|medication and while you are using it. Keep all medical and lab||
2479|128|N|appointments. Consult your doctor for more details.||
2479|129|B|||
2479|130|D|MISSED DOSE:  It is important to get each dose of this medication||
2479|131|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2479|132|D|right away for a new dosing schedule.||
2479|133|B|||
2479|134|R|STORAGE:  Not applicable. This medication is given in a hospital||
2479|135|R|or clinic setting and will not be stored at home.||
2479|136|B|||
2479|137|A|Information last revised September 2025.||
2479|138|A|Copyright(c) 2025 First Databank, Inc.||
2479|139|B|||
2480|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2480|002|Z|does NOT have all possible information about this product. This||
2480|003|Z|information does not assure that this product is safe, effective,||
2480|004|Z|or appropriate for you. This information is not individual||
2480|005|Z|medical advice and does not substitute for the advice of your||
2480|006|Z|health care professional. Always ask your health care||
2480|007|Z|professional for complete information about this product and your||
2480|008|Z|specific health needs.||
2480|009|B|||
2480|010|T|PEGCETACOPLAN - INTRAOCULAR||
2480|011|F|(peg-SET-a-KOE-plan)||
2480|012|B|||
2480|013|C|COMMON BRAND NAME(S): Syfovre||
2480|014|B|||
2480|015|U|USES:  Pegcetacoplan is used to treat a certain serious eye||
2480|016|U|condition (geographic atrophy). It may help to delay vision loss.||
2480|017|U|Pegcetacoplan works by helping to block your immune system from||
2480|018|U|destroying cells in your eye.||
2480|019|B|||
2480|020|H|HOW TO USE:  This medication is prepared and given by injection||
2480|021|H|into the affected eye(s) by a health care professional. The||
2480|022|H|affected eye is numbed before each injection. After the||
2480|023|H|injection, you will remain in the doctor's office for a while,||
2480|024|H|and your eye(s) and vision will be monitored.||
2480|025|H|   This medication is given as directed by your doctor, usually||
2480|026|H|once every 25 to 60 days. The treatment schedule is based on your||
2480|027|H|medical condition and response to treatment.||
2480|028|H|   Use this medication regularly to get the most benefit from it.||
2480|029|H|To help you remember, mark your calendar with a reminder.||
2480|030|H|   Tell your doctor if your condition gets worse.||
2480|031|B|||
2480|032|S|SIDE EFFECTS:  Eye irritation or discomfort may occur. If either||
2480|033|S|of these effects lasts or gets worse, tell your doctor or||
2480|034|S|pharmacist promptly.||
2480|035|S|   Remember that this medication has been prescribed because your||
2480|036|S|doctor has judged that the benefit to you is greater than the||
2480|037|S|risk of side effects. Many people using this medication do not||
2480|038|S|have serious side effects.||
2480|039|S|   Tell your doctor right away if you have any serious side||
2480|040|S|effects, including: floaters (blurry shapes that seem to float in||
2480|041|S|front of your eyes), swelling in the eye(s).||
2480|042|S|   This medication may rarely increase your risk for developing||
2480|043|S|certain serious eye conditions (such as endophthalmitis, retinal||
2480|044|S|detachment). Get medical help right away if you notice any of||
2480|045|S|these symptoms in the affected eye(s): pain, redness, sensitivity||
2480|046|S|to light, vision changes (such as blurred vision, loss of||
2480|047|S|vision).||
2480|048|S|   A very serious allergic reaction to this drug is rare.||
2480|049|S|However, get medical help right away if you notice any symptoms||
2480|050|S|of a serious allergic reaction, including: rash, itching/swelling||
2480|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2480|052|S|breathing.||
2480|053|S|   This is not a complete list of possible side effects. If you||
2480|054|S|notice other effects not listed above, contact your doctor or||
2480|055|S|pharmacist.||
2480|056|S|   In the US -||
2480|057|S|   Call your doctor for medical advice about side effects. You||
2480|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2480|059|S|www.fda.gov/medwatch.||
2480|060|S|   In Canada - Call your doctor for medical advice about side||
2480|061|S|effects. You may report side effects to Health Canada at||
2480|062|S|1-866-234-2345.||
2480|063|B|||
2480|064|P|PRECAUTIONS:  Before using pegcetacoplan, tell your doctor or||
2480|065|P|pharmacist if you are allergic to it; or if you have any other||
2480|066|P|allergies. This product may contain inactive ingredients, which||
2480|067|P|can cause allergic reactions or other problems. Talk to your||
2480|068|P|pharmacist for more details.||
2480|069|P|   Before using this medication, tell your doctor or pharmacist||
2480|070|P|your medical history, especially of: current eye||
2480|071|P|infection/swelling.||
2480|072|P|   This drug may cause temporary blurred vision. Do not drive,||
2480|073|P|use machinery, or do anything that needs clear vision until you||
2480|074|P|can do it safely.||
2480|075|P|   Before having surgery, tell your doctor or dentist about all||
2480|076|P|the products you use (including prescription drugs,||
2480|077|P|nonprescription drugs, and herbal products).||
2480|078|P|   During pregnancy, this medication should be used only when||
2480|079|P|clearly needed. Discuss the risks and benefits and ask your||
2480|080|P|doctor which reliable forms of birth control to use during||
2480|081|P|treatment and for 40 days after the last dose. If you become||
2480|082|P|pregnant or think you may be pregnant, tell your doctor right||
2480|083|P|away.||
2480|084|P|   It is unknown if this medication passes into breast milk.||
2480|085|P|Consult your doctor before breastfeeding.||
2480|086|B|||
2480|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2480|088|I|medications work or increase your risk for serious side effects.||
2480|089|I|This document does not contain all possible drug interactions.||
2480|090|I|Keep a list of all the products you use (including||
2480|091|I|prescription/nonprescription drugs and herbal products) and share||
2480|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
2480|093|I|the dosage of any medicines without your doctor's approval.||
2480|094|B|||
2480|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2480|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2480|097|O|poison control center right away. US residents can call||
2480|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2480|099|B|||
2480|100|N|NOTES:  Medical tests (such as eye exams) should be done while||
2480|101|N|you are using this medication. Keep all medical appointments.||
2480|102|N|Consult your doctor for more details.||
2480|103|B|||
2480|104|D|MISSED DOSE:  It is important to get each dose of this medication||
2480|105|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2480|106|D|right away for a new dosing schedule.||
2480|107|B|||
2480|108|R|STORAGE:  Not applicable. This medication is given in a hospital||
2480|109|R|or doctor's office and will not be stored at home.||
2480|110|B|||
2480|111|A|Information last revised October 2024.||
2480|112|A|Copyright(c) 2025 First Databank, Inc.||
2480|113|B|||
2481|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2481|002|Z|does NOT have all possible information about this product. This||
2481|003|Z|information does not assure that this product is safe, effective,||
2481|004|Z|or appropriate for you. This information is not individual||
2481|005|Z|medical advice and does not substitute for the advice of your||
2481|006|Z|health care professional. Always ask your health care||
2481|007|Z|professional for complete information about this product and your||
2481|008|Z|specific health needs.||
2481|009|B|||
2481|010|T|BEZLOTOXUMAB - INJECTION||
2481|011|F|(BEZ-loe-TOX-ue-mab)||
2481|012|B|||
2481|013|C|COMMON BRAND NAME(S): Zinplava||
2481|014|B|||
2481|015|U|USES:  Bezlotoxumab is used to prevent the return of a severe||
2481|016|U|intestinal infection due to a bacteria called C. difficile.||
2481|017|U|Bezlotoxumab belongs to a class of drugs known as monoclonal||
2481|018|U|antibodies. It works by blocking the effects of toxins made by C.||
2481|019|U|difficile bacteria during an infection.||
2481|020|U|   Bezlotoxumab is not an antibiotic and will not work to treat||
2481|021|U|bacterial infections. Your doctor will prescribe a separate||
2481|022|U|antibiotic to treat your C. difficile infection. Carefully follow||
2481|023|U|your doctor's directions for all your medications.||
2481|024|B|||
2481|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2481|026|H|from your pharmacist before you start using bezlotoxumab. If you||
2481|027|H|have any questions, ask your doctor or pharmacist.||
2481|028|H|   This medication is given by a health care professional. It is||
2481|029|H|injected slowly into a vein over 60 minutes, as directed by your||
2481|030|H|doctor, usually as a single dose. The dosage is based on your||
2481|031|H|medical condition, weight, and response to treatment.||
2481|032|H|   Infusion reactions may happen during the infusion of this drug||
2481|033|H|and for 24 hours afterward. Tell your doctor right away if you||
2481|034|H|have any symptoms of infusion reactions such as nausea,||
2481|035|H|tiredness, fever, dizziness, headache, or shortness of breath.||
2481|036|H|   Tell your doctor if your condition lasts or gets worse.||
2481|037|B|||
2481|038|S|SIDE EFFECTS:  See also How to Use section.||
2481|039|S|   Remember that this medication has been prescribed because your||
2481|040|S|doctor has judged that the benefit to you is greater than the||
2481|041|S|risk of side effects. Many people using this medication do not||
2481|042|S|have serious side effects.||
2481|043|S|   Tell your doctor right away if you have any serious side||
2481|044|S|effects, including: symptoms of heart failure (such as shortness||
2481|045|S|of breath, swelling ankles/feet, unusual tiredness,||
2481|046|S|unusual/sudden weight gain).||
2481|047|S|   A very serious allergic reaction to this drug is rare.||
2481|048|S|However, get medical help right away if you notice any symptoms||
2481|049|S|of a serious allergic reaction, including: rash, itching/swelling||
2481|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2481|051|S|breathing.||
2481|052|S|   This is not a complete list of possible side effects. If you||
2481|053|S|notice other effects not listed above, contact your doctor or||
2481|054|S|pharmacist.||
2481|055|S|   In the US -||
2481|056|S|   Call your doctor for medical advice about side effects. You||
2481|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2481|058|S|www.fda.gov/medwatch.||
2481|059|S|   In Canada - Call your doctor for medical advice about side||
2481|060|S|effects. You may report side effects to Health Canada at||
2481|061|S|1-866-234-2345.||
2481|062|B|||
2481|063|P|PRECAUTIONS:  Before receiving bezlotoxumab, tell your doctor or||
2481|064|P|pharmacist if you have any allergies. This product may contain||
2481|065|P|inactive ingredients, which can cause allergic reactions or other||
2481|066|P|problems. Talk to your pharmacist for more details.||
2481|067|P|   Before using this medication, tell your doctor or pharmacist||
2481|068|P|your medical history, especially of: heart failure.||
2481|069|P|   Before having surgery, tell your doctor or dentist about all||
2481|070|P|the products you use (including prescription drugs,||
2481|071|P|nonprescription drugs, and herbal products).||
2481|072|P|   During pregnancy, this medication should be used only when||
2481|073|P|clearly needed. Discuss the risks and benefits with your doctor.||
2481|074|P|   It is unknown if this medication passes into breast milk.||
2481|075|P|Consult your doctor before breastfeeding.||
2481|076|B|||
2481|077|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2481|078|I|medications work or increase your risk for serious side effects.||
2481|079|I|This document does not contain all possible drug interactions.||
2481|080|I|Keep a list of all the products you use (including||
2481|081|I|prescription/nonprescription drugs and herbal products) and share||
2481|082|I|it with your doctor and pharmacist. Do not start, stop, or change||
2481|083|I|the dosage of any medicines without your doctor's approval.||
2481|084|B|||
2481|085|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2481|086|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2481|087|O|poison control center right away. US residents can call||
2481|088|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2481|089|B|||
2481|090|N|NOTES:  Do not share this medication with others.||
2481|091|N|   Lab and/or medical tests (such as stool tests) may be done||
2481|092|N|while you are using this medication. Keep all medical and lab||
2481|093|N|appointments. Consult your doctor for more details.||
2481|094|B|||
2481|095|D|MISSED DOSE:  Not applicable.||
2481|096|B|||
2481|097|R|STORAGE:  Not applicable. This medication is given in a hospital||
2481|098|R|or clinic or doctor's office and will not be stored at home.||
2481|099|B|||
2481|100|A|Information last revised May 2024.||
2481|101|A|Copyright(c) 2025 First Databank, Inc.||
2481|102|B|||
2482|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2482|002|Z|does NOT have all possible information about this product. This||
2482|003|Z|information does not assure that this product is safe, effective,||
2482|004|Z|or appropriate for you. This information is not individual||
2482|005|Z|medical advice and does not substitute for the advice of your||
2482|006|Z|health care professional. Always ask your health care||
2482|007|Z|professional for complete information about this product and your||
2482|008|Z|specific health needs.||
2482|009|B|||
2482|010|T|SPARSENTAN - ORAL||
2482|011|F|(spar-SEN-tan)||
2482|012|B|||
2482|013|C|COMMON BRAND NAME(S): Filspari||
2482|014|B|||
2482|015|W|WARNING:  Sparsentan can rarely cause liver problems. Your doctor||
2482|016|W|will order liver function tests before you start taking||
2482|017|W|sparsentan, then every 3 months while you are taking this||
2482|018|W|medication. Tell your doctor right away if you develop symptoms||
2482|019|W|of liver disease, such as nausea/vomiting that doesn't stop, loss||
2482|020|W|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2482|021|W|urine. Your doctor may stop your treatment for some time if you||
2482|022|W|get serious side effects.||
2482|023|W|   This medication must not be used during pregnancy. It may harm||
2482|024|W|an unborn baby. It is important to prevent pregnancy while taking||
2482|025|W|this medication and for 2 weeks after treatment. Female patients||
2482|026|W|must use reliable birth control before starting treatment, during||
2482|027|W|treatment, and for 2 weeks after the last dose. Ask your doctor||
2482|028|W|which forms of birth control to use while taking this medication.||
2482|029|W|Female patients must take a pregnancy test before starting||
2482|030|W|treatment. If you become pregnant or think you may be pregnant,||
2482|031|W|tell your doctor right away.||
2482|032|W|   To receive sparsentan in the United States, you must||
2482|033|W|understand, agree to, and carefully follow the requirements of||
2482|034|W|the REMS Program for this medication. If you live in Canada or||
2482|035|W|any other country, consult your doctor and pharmacist for your||
2482|036|W|country's regulations.||
2482|037|B|||
2482|038|U|USES:  This medication is used to treat a certain kidney problem||
2482|039|U|(IgAN - primary immunoglobulin A nephropathy). Sparsentan helps||
2482|040|U|to lower levels of protein in the urine.||
2482|041|B|||
2482|042|H|HOW TO USE:  Read the Medication Guide provided by your||
2482|043|H|pharmacist before you start taking sparsentan and each time you||
2482|044|H|get a refill. If you have any questions, ask your doctor or||
2482|045|H|pharmacist.||
2482|046|H|   Take this medication by mouth as directed by your doctor,||
2482|047|H|usually once daily before a meal. You may take this medication||
2482|048|H|before your morning or evening meal, but it is important to||
2482|049|H|choose one way and take this medication the same way with every||
2482|050|H|dose. Swallow the tablets whole with water. Do not crush or chew||
2482|051|H|the tablets. The dosage is based on your medical condition and||
2482|052|H|response to treatment. To reduce your risk of side effects, your||
2482|053|H|doctor may direct you to start this medication at a low dose and||
2482|054|H|gradually increase your dose. Follow your doctor's instructions||
2482|055|H|carefully.||
2482|056|H|   Antacids can decrease the absorption of sparsentan. If you are||
2482|057|H|taking an antacid, take sparsentan 2 hours before or 2 hours||
2482|058|H|after taking antacids.||
2482|059|H|   Use this medication regularly to get the most benefit from it.||
2482|060|H|To help you remember, take it at the same time each day.||
2482|061|H|   Since this drug can be absorbed through the skin and lungs and||
2482|062|H|may harm an unborn baby, women who are pregnant or who may become||
2482|063|H|pregnant should not handle this medication or breathe the dust||
2482|064|H|from the tablets.||
2482|065|H|   Tell your doctor if your condition does not get better or gets||
2482|066|H|worse.||
2482|067|B|||
2482|068|S|SIDE EFFECTS:  See also Warning section.||
2482|069|S|   Dizziness may occur. If this effect lasts or gets worse, tell||
2482|070|S|your doctor or pharmacist promptly.||
2482|071|S|   To reduce the risk of dizziness and lightheadedness, get up||
2482|072|S|slowly when rising from a sitting or lying position.||
2482|073|S|   Remember that this medication has been prescribed because your||
2482|074|S|doctor has judged that the benefit to you is greater than the||
2482|075|S|risk of side effects. Many people using this medication do not||
2482|076|S|have serious side effects.||
2482|077|S|   Tell your doctor right away if you have any serious side||
2482|078|S|effects, including: symptoms of a high potassium blood level||
2482|079|S|(such as muscle weakness, slow/irregular heartbeat), unusual||
2482|080|S|weight gain, swelling of ankles/legs/feet.||
2482|081|S|   Although sparsentan may be used to treat people who have||
2482|082|S|kidney problems, it may also rarely cause serious kidney problems||
2482|083|S|or make them worse. Your doctor will check your kidney function||
2482|084|S|while you are taking sparsentan. Tell your doctor right away if||
2482|085|S|you have any signs of kidney problems such as a change in the||
2482|086|S|amount of urine.||
2482|087|S|   A very serious allergic reaction to this drug is rare.||
2482|088|S|However, get medical help right away if you notice any symptoms||
2482|089|S|of a serious allergic reaction, including: rash, itching/swelling||
2482|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2482|091|S|breathing.||
2482|092|S|   This is not a complete list of possible side effects. If you||
2482|093|S|notice other effects not listed above, contact your doctor or||
2482|094|S|pharmacist.||
2482|095|S|   In the US -||
2482|096|S|   Call your doctor for medical advice about side effects. You||
2482|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2482|098|S|www.fda.gov/medwatch.||
2482|099|S|   In Canada - Call your doctor for medical advice about side||
2482|100|S|effects. You may report side effects to Health Canada at||
2482|101|S|1-866-234-2345.||
2482|102|B|||
2482|103|P|PRECAUTIONS:  Before taking sparsentan, tell your doctor or||
2482|104|P|pharmacist if you are allergic to it; or if you have any other||
2482|105|P|allergies. This product may contain inactive ingredients, which||
2482|106|P|can cause allergic reactions or other problems. Talk to your||
2482|107|P|pharmacist for more details.||
2482|108|P|   Before using this medication, tell your doctor or pharmacist||
2482|109|P|your medical history, especially of: liver problems.||
2482|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2482|111|P|can make you more dizzy. Do not drive, use machinery, or do||
2482|112|P|anything that needs alertness until you can do it safely. Limit||
2482|113|P|alcoholic beverages. Talk to your doctor if you are using||
2482|114|P|marijuana (cannabis).||
2482|115|P|   This medication may increase your potassium levels. Before||
2482|116|P|using potassium supplements or salt substitutes that contain||
2482|117|P|potassium, consult your doctor or pharmacist.||
2482|118|P|   Before having surgery, tell your doctor or dentist about all||
2482|119|P|the products you use (including prescription drugs,||
2482|120|P|nonprescription drugs, and herbal products).||
2482|121|P|   Since this drug can be absorbed through the skin and lungs and||
2482|122|P|may harm an unborn baby, women who are pregnant or who may become||
2482|123|P|pregnant should not handle this medication or breathe the dust||
2482|124|P|from the tablets.||
2482|125|P|   This medication must not be used during pregnancy. It may harm||
2482|126|P|an unborn baby. Discuss the use of reliable forms of birth||
2482|127|P|control (such as condoms, birth control pills) before starting||
2482|128|P|treatment, during treatment, and for 2 weeks after the last dose.||
2482|129|P|If you become pregnant or think you may be pregnant, tell your||
2482|130|P|doctor right away. See also Warning section.||
2482|131|P|   It is unknown if this medication passes into breast milk.||
2482|132|P|Because of the possible risk to the infant, breastfeeding is not||
2482|133|P|recommended while using this medication. Consult your doctor||
2482|134|P|before breastfeeding.||
2482|135|B|||
2482|136|I|DRUG INTERACTIONS:  See also How to Use section.||
2482|137|I|   Drug interactions may change how your medications work or||
2482|138|I|increase your risk for serious side effects. This document does||
2482|139|I|not contain all possible drug interactions. Keep a list of all||
2482|140|I|the products you use (including prescription/nonprescription||
2482|141|I|drugs and herbal products) and share it with your doctor and||
2482|142|I|pharmacist. Do not start, stop, or change the dosage of any||
2482|143|I|medicines without your doctor's approval.||
2482|144|I|   Some products that may interact with this drug are: aliskiren,||
2482|145|I|ARBs (such as losartan, valsartan), certain drugs used to treat||
2482|146|I|pulmonary hypertension (such as ambrisentan, bosentan,||
2482|147|I|macitentan), certain drugs that reduce stomach acid (including H2||
2482|148|I|blockers such as famotidine, proton pump inhibitors such as||
2482|149|I|omeprazole).||
2482|150|I|   Other medications can affect the removal of sparsentan from||
2482|151|I|your body, which may affect how sparsentan works. Examples||
2482|152|I|include adagrasib, azole antifungals (such as itraconazole,||
2482|153|I|ketoconazole), cobicistat, enzalutamide, certain HIV protease||
2482|154|I|inhibitors (such as nelfinavir), certain macrolide antibiotics||
2482|155|I|(such as clarithromycin), rifampin, certain drugs used to treat||
2482|156|I|seizures (such as carbamazepine, phenytoin), St. John's wort,||
2482|157|I|among others.||
2482|158|B|||
2482|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2482|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2482|161|O|poison control center right away. US residents can call||
2482|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2482|163|B|||
2482|164|N|NOTES:  Do not share this medication with others.||
2482|165|N|   Lab and/or medical tests (such as liver/kidney function, urine||
2482|166|N|protein levels, potassium levels, blood pressure) should be done||
2482|167|N|before you start taking this medication and while you are taking||
2482|168|N|it. Keep all medical and lab appointments. Consult your doctor||
2482|169|N|for more details.||
2482|170|B|||
2482|171|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2482|172|D|remember. If it is near the time of the next dose, skip the||
2482|173|D|missed dose. Take your next dose at the regular time. Do not||
2482|174|D|double the dose to catch up.||
2482|175|B|||
2482|176|R|STORAGE:  Store in the original container at room temperature||
2482|177|R|away from light and moisture. Do not store in the bathroom. Keep||
2482|178|R|all medications away from children and pets.||
2482|179|R|   Do not flush medications down the toilet or pour them into a||
2482|180|R|drain unless instructed to do so. Properly discard this product||
2482|181|R|when it is expired or no longer needed. Consult your pharmacist||
2482|182|R|or local waste disposal company.||
2482|183|B|||
2482|184|A|Information last revised September 2025.||
2482|185|A|Copyright(c) 2025 First Databank, Inc.||
2482|186|B|||
2483|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2483|002|Z|does NOT have all possible information about this product. This||
2483|003|Z|information does not assure that this product is safe, effective,||
2483|004|Z|or appropriate for you. This information is not individual||
2483|005|Z|medical advice and does not substitute for the advice of your||
2483|006|Z|health care professional. Always ask your health care||
2483|007|Z|professional for complete information about this product and your||
2483|008|Z|specific health needs.||
2483|009|B|||
2483|010|T|OMAVELOXOLONE - ORAL||
2483|011|F|(OH-ma-vel-OX-oh-lone)||
2483|012|B|||
2483|013|C|COMMON BRAND NAME(S): Skyclarys||
2483|014|B|||
2483|015|U|USES:  Omaveloxolone is used to treat a certain disorder that||
2483|016|U|affects nerves and muscles (Friedreich's ataxia). This disorder||
2483|017|U|causes damage to your nerves, which results in loss of||
2483|018|U|coordination and unsteady movements. Omaveloxolone may help to||
2483|019|U|lessen symptoms of Friedreich's ataxia.||
2483|020|B|||
2483|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2483|022|H|from your pharmacist before you start taking omaveloxolone and||
2483|023|H|each time you get a refill. If you have any questions, ask your||
2483|024|H|doctor or pharmacist.||
2483|025|H|   Take this medication by mouth on an empty stomach (at least 1||
2483|026|H|hour before or 2 hours after eating) as directed by your doctor,||
2483|027|H|usually once daily. Swallow the capsules whole. Do not crush or||
2483|028|H|chew the capsules.||
2483|029|H|   If you are having trouble swallowing the capsules, you may||
2483|030|H|open the capsule and carefully sprinkle its contents onto 2||
2483|031|H|tablespoons/30 milliliters of applesauce. Stir the||
2483|032|H|drug/applesauce mixture and swallow all of it right away. Do not||
2483|033|H|prepare a supply for future use. Do not mix the contents of the||
2483|034|H|capsule with milk or orange juice. Do not give this medication||
2483|035|H|through a feeding tube.||
2483|036|H|   The dosage is based on your medical condition, response to||
2483|037|H|treatment, and other medications you may be taking. Be sure to||
2483|038|H|tell your doctor and pharmacist about all the products you use||
2483|039|H|(including prescription drugs, nonprescription drugs, and herbal||
2483|040|H|products).||
2483|041|H|   Use this medication regularly to get the most benefit from it.||
2483|042|H|To help you remember, take it at the same time each day.||
2483|043|H|   Do not increase your dose or use this drug more often or for||
2483|044|H|longer than prescribed. Your condition will not improve any||
2483|045|H|faster, and your risk of side effects will increase.||
2483|046|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2483|047|H|using this medication unless your doctor or pharmacist says you||
2483|048|H|may do so safely. Grapefruit can increase the chance of side||
2483|049|H|effects with this medicine. Ask your doctor or pharmacist for||
2483|050|H|more details.||
2483|051|H|   Tell your doctor if your condition gets worse.||
2483|052|B|||
2483|053|S|SIDE EFFECTS:  Nausea, diarrhea, or stomach pain may occur. If||
2483|054|S|any of these effects last or get worse, tell your doctor or||
2483|055|S|pharmacist promptly.||
2483|056|S|   Remember that this medication has been prescribed because your||
2483|057|S|doctor has judged that the benefit to you is greater than the||
2483|058|S|risk of side effects. Many people using this medication do not||
2483|059|S|have serious side effects.||
2483|060|S|   Tell your doctor right away if you have any serious side||
2483|061|S|effects, including: signs of liver problems (such as||
2483|062|S|nausea/vomiting that doesn't stop, loss of appetite,||
2483|063|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2483|064|S|sudden/unexplained weight gain, swelling ankles/feet/hands,||
2483|065|S|pounding heartbeat, shortness of breath.||
2483|066|S|   A very serious allergic reaction to this drug is rare.||
2483|067|S|However, get medical help right away if you notice any symptoms||
2483|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2483|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2483|070|S|breathing.||
2483|071|S|   This is not a complete list of possible side effects. If you||
2483|072|S|notice other effects not listed above, contact your doctor or||
2483|073|S|pharmacist.||
2483|074|S|   In the US -||
2483|075|S|   Call your doctor for medical advice about side effects. You||
2483|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2483|077|S|www.fda.gov/medwatch.||
2483|078|S|   In Canada - Call your doctor for medical advice about side||
2483|079|S|effects. You may report side effects to Health Canada at||
2483|080|S|1-866-234-2345.||
2483|081|B|||
2483|082|P|PRECAUTIONS:  Before taking omaveloxolone, tell your doctor or||
2483|083|P|pharmacist if you are allergic to it; or if you have any other||
2483|084|P|allergies. This product may contain inactive ingredients, which||
2483|085|P|can cause allergic reactions or other problems. Talk to your||
2483|086|P|pharmacist for more details.||
2483|087|P|   Before using this medication, tell your doctor or pharmacist||
2483|088|P|your medical history, especially of: liver disease, heart||
2483|089|P|failure, high cholesterol.||
2483|090|P|   Before having surgery, tell your doctor or dentist about all||
2483|091|P|the products you use (including prescription drugs,||
2483|092|P|nonprescription drugs, and herbal products).||
2483|093|P|   During pregnancy, this medication should be used only when||
2483|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
2483|095|P|   It is unknown if this medication passes into breast milk.||
2483|096|P|Consult your doctor before breastfeeding.||
2483|097|B|||
2483|098|I|DRUG INTERACTIONS:  See also How to Use section.||
2483|099|I|   Drug interactions may change how your medications work or||
2483|100|I|increase your risk for serious side effects. This document does||
2483|101|I|not contain all possible drug interactions. Keep a list of all||
2483|102|I|the products you use (including prescription/nonprescription||
2483|103|I|drugs and herbal products) and share it with your doctor and||
2483|104|I|pharmacist. Do not start, stop, or change the dosage of any||
2483|105|I|medicines without your doctor's approval.||
2483|106|I|   This medication may decrease the effectiveness of hormonal||
2483|107|I|birth control such as pills, patch, or ring. This could cause||
2483|108|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2483|109|I|use reliable backup birth control methods while using this||
2483|110|I|medication and for 28 days after the last dose. Also tell your||
2483|111|I|doctor if you have any new spotting or breakthrough bleeding,||
2483|112|I|because these may be signs that your birth control is not working||
2483|113|I|well.||
2483|114|B|||
2483|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2483|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2483|117|O|poison control center right away. US residents can call||
2483|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2483|119|B|||
2483|120|N|NOTES:  Do not share this medication with others.||
2483|121|N|   Lab and/or medical tests (such as liver function, cholesterol||
2483|122|N|levels, weight) should be done before you start taking this||
2483|123|N|medication and while you are taking it. Keep all medical and lab||
2483|124|N|appointments. Consult your doctor for more details.||
2483|125|B|||
2483|126|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2483|127|D|next dose at the regular time. Do not double the dose to catch||
2483|128|D|up.||
2483|129|B|||
2483|130|R|STORAGE:  Store at room temperature away from light and moisture.||
2483|131|R|Do not store in the bathroom. Keep all medications away from||
2483|132|R|children and pets.||
2483|133|R|   Do not flush medications down the toilet or pour them into a||
2483|134|R|drain unless instructed to do so. Properly discard this product||
2483|135|R|when it is expired or no longer needed. Consult your pharmacist||
2483|136|R|or local waste disposal company.||
2483|137|B|||
2483|138|A|Information last revised June 2025.||
2483|139|A|Copyright(c) 2025 First Databank, Inc.||
2483|140|B|||
2484|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2484|002|Z|does NOT have all possible information about this product. This||
2484|003|Z|information does not assure that this product is safe, effective,||
2484|004|Z|or appropriate for you. This information is not individual||
2484|005|Z|medical advice and does not substitute for the advice of your||
2484|006|Z|health care professional. Always ask your health care||
2484|007|Z|professional for complete information about this product and your||
2484|008|Z|specific health needs.||
2484|009|B|||
2484|010|T|IDURSULFASE - INJECTION||
2484|011|F|(Eye-dur-SUL-fase)||
2484|012|B|||
2484|013|C|COMMON BRAND NAME(S): Elaprase||
2484|014|B|||
2484|015|W|WARNING:  Idursulfase may rarely cause serious (sometimes fatal)||
2484|016|W|allergic reactions that may happen while receiving idursulfase||
2484|017|W|and for 24 hours after the infusion. A health care professional||
2484|018|W|will monitor you closely during and after your infusion. Get||
2484|019|W|medical help right away if you notice any signs of a serious||
2484|020|W|allergic reaction, such as rash, itching/swelling (especially of||
2484|021|W|the face/tongue/throat), severe dizziness, or trouble breathing.||
2484|022|W|Your doctor may prescribe other medications (such as||
2484|023|W|antihistamines, corticosteroids) to treat these side effects.||
2484|024|W|Your infusion may also be slowed down or stopped depending on||
2484|025|W|your symptoms.||
2484|026|W|   Before you start your infusion, tell your doctor if you have||
2484|027|W|breathing problems or a fever. Breathing problems may get worse||
2484|028|W|during the infusion. Your doctor may delay your infusion or||
2484|029|W|monitor you for longer periods after your infusion.||
2484|030|B|||
2484|031|U|USES:  Idursulfase is used to treat a certain inherited condition||
2484|032|U|(mucopolysaccharidosis type II-Hunter syndrome) that causes a||
2484|033|U|buildup of a certain substance (glycosaminoglycan-GAG) in the||
2484|034|U|body. Idursulfase works by breaking down GAGs in the body. This||
2484|035|U|medication may improve how far you can walk.||
2484|036|B|||
2484|037|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2484|038|H|from your pharmacist before you start using idursulfase and each||
2484|039|H|time you get an infusion. If you have any questions, ask your||
2484|040|H|doctor or pharmacist.||
2484|041|H|   This medication is given by injection into a vein by a health||
2484|042|H|care professional. It is given as directed by your doctor,||
2484|043|H|usually once weekly. The first dose is injected slowly into a||
2484|044|H|vein over 3 hours. Later doses may be given over a shorter time.||
2484|045|H|The dosage and treatment schedule are based on your medical||
2484|046|H|condition, weight, and response to treatment.||
2484|047|H|   Infusion reactions may happen during the infusion of this||
2484|048|H|drug. Your doctor may prescribe other medications before each||
2484|049|H|treatment to help prevent these side effects. Tell your doctor||
2484|050|H|right away if you have any symptoms of infusion reactions such as||
2484|051|H|headache, dizziness, flushing, fever, nausea, or vomiting. Your||
2484|052|H|doctor may slow down or stop your treatment for some time.||
2484|053|H|   Use this medication regularly to get the most benefit from it.||
2484|054|H|To help you remember, mark your calendar with a reminder.||
2484|055|H|   Tell your doctor if your condition gets worse.||
2484|056|B|||
2484|057|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2484|058|S|   Remember that this medication has been prescribed because your||
2484|059|S|doctor has judged that the benefit to you is greater than the||
2484|060|S|risk of side effects. Many people using this medication do not||
2484|061|S|have serious side effects.||
2484|062|S|   A very serious allergic reaction to this drug is rare.||
2484|063|S|However, get medical help right away if you notice any symptoms||
2484|064|S|of a serious allergic reaction, including: rash, itching/swelling||
2484|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2484|066|S|breathing.||
2484|067|S|   This is not a complete list of possible side effects. If you||
2484|068|S|notice other effects not listed above, contact your doctor or||
2484|069|S|pharmacist.||
2484|070|S|   In the US -||
2484|071|S|   Call your doctor for medical advice about side effects. You||
2484|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2484|073|S|www.fda.gov/medwatch.||
2484|074|S|   In Canada - Call your doctor for medical advice about side||
2484|075|S|effects. You may report side effects to Health Canada at||
2484|076|S|1-866-234-2345.||
2484|077|B|||
2484|078|P|PRECAUTIONS:  See also Warning section.||
2484|079|P|   Before using idursulfase, tell your doctor or pharmacist if||
2484|080|P|you are allergic to it; or if you have any other allergies. This||
2484|081|P|product may contain inactive ingredients, which can cause||
2484|082|P|allergic reactions or other problems. Talk to your pharmacist for||
2484|083|P|more details.||
2484|084|P|   Before using this medication, tell your doctor or pharmacist||
2484|085|P|your medical history, especially of: swelling, heart failure.||
2484|086|P|   Before having surgery, tell your doctor or dentist about all||
2484|087|P|the products you use (including prescription drugs,||
2484|088|P|nonprescription drugs, and herbal products).||
2484|089|P|   During pregnancy, this medication should be used only when||
2484|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
2484|091|P|   It is unknown if this medication passes into breast milk.||
2484|092|P|Consult your doctor before breastfeeding.||
2484|093|B|||
2484|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2484|095|I|medications work or increase your risk for serious side effects.||
2484|096|I|This document does not contain all possible drug interactions.||
2484|097|I|Keep a list of all the products you use (including||
2484|098|I|prescription/nonprescription drugs and herbal products) and share||
2484|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2484|100|I|the dosage of any medicines without your doctor's approval.||
2484|101|B|||
2484|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2484|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2484|104|O|poison control center right away. US residents can call||
2484|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2484|106|B|||
2484|107|N|NOTES:  Keep all medical and lab appointments.||
2484|108|B|||
2484|109|D|MISSED DOSE:  It is important to get each dose of this medication||
2484|110|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2484|111|D|right away for a new dosing schedule.||
2484|112|B|||
2484|113|R|STORAGE:  Not applicable. This medication is given in a hospital||
2484|114|R|or clinic or doctor's office and will not be stored at home.||
2484|115|B|||
2484|116|A|Information last revised October 2024.||
2484|117|A|Copyright(c) 2025 First Databank, Inc.||
2484|118|B|||
2485|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2485|002|Z|does NOT have all possible information about this product. This||
2485|003|Z|information does not assure that this product is safe, effective,||
2485|004|Z|or appropriate for you. This information is not individual||
2485|005|Z|medical advice and does not substitute for the advice of your||
2485|006|Z|health care professional. Always ask your health care||
2485|007|Z|professional for complete information about this product and your||
2485|008|Z|specific health needs.||
2485|009|B|||
2485|010|T|ZAVEGEPANT SPRAY - NASAL||
2485|011|B|||
2485|012|C|COMMON BRAND NAME(S): Zavzpret||
2485|013|B|||
2485|014|U|USES:  This medication is used to treat migraines. Zavegepant may||
2485|015|U|work by blocking the effects of a certain natural substance in||
2485|016|U|the brain that causes migraines (calcitonin gene-related peptide||
2485|017|U|- CGRP).||
2485|018|B|||
2485|019|H|HOW TO USE:  Read the Patient Information Leaflet and||
2485|020|H|Instructions for Use if available from your pharmacist before you||
2485|021|H|start using zavegepant and each time you get a refill. If you||
2485|022|H|have any questions, ask your doctor or pharmacist.||
2485|023|H|   This product is for use in the nose only. Remove the||
2485|024|H|zavegepant spray from the package only when you are ready to use||
2485|025|H|it. Do not test or prime the spray before use. Doing so will make||
2485|026|H|you lose the dose.||
2485|027|H|   Use this medication at the first sign of a migraine as||
2485|028|H|directed by your doctor, usually 1 spray into one nostril. Do not||
2485|029|H|use more than one dose in a 24-hour period. Avoid spraying into||
2485|030|H|your eyes. Gently blow your nose before using this medication.||
2485|031|H|Keeping your head upright, close one nostril by pressing with||
2485|032|H|your index finger on one side of your nose. Place the nozzle of||
2485|033|H|the spray device into the other nostril and breathe in gently as||
2485|034|H|you press the plunger. Keep your head upright, remove the nozzle||
2485|035|H|from your nose, and gently breathe in through your nose and out||
2485|036|H|through your mouth for 10 to 20 seconds. Do not use more than 8||
2485|037|H|doses of this medication per month.||
2485|038|H|   Avoid using decongestant nasal sprays at the same time as this||
2485|039|H|medication. If needed, use decongestant nasal sprays at least 1||
2485|040|H|hour after using zavegepant.||
2485|041|H|   If you are using drugs for migraine attacks on 10 or more days||
2485|042|H|each month, the drugs may actually make your headaches worse||
2485|043|H|(medication overuse headache). Do not use medications more often||
2485|044|H|or for longer than directed. Tell your doctor if you need to use||
2485|045|H|this medication more often, or if the medication is not working||
2485|046|H|as well, or if your headaches get worse.||
2485|047|B|||
2485|048|S|SIDE EFFECTS:  Nausea, unusual taste or loss of taste, or||
2485|049|S|irritation of the nose may occur. If any of these effects last or||
2485|050|S|get worse, tell your doctor or pharmacist promptly.||
2485|051|S|   Remember that this medication has been prescribed because your||
2485|052|S|doctor has judged that the benefit to you is greater than the||
2485|053|S|risk of side effects. Many people using this medication do not||
2485|054|S|have serious side effects.||
2485|055|S|   This medication may raise your blood pressure. Check your||
2485|056|S|blood pressure regularly and tell your doctor if the results are||
2485|057|S|high. Your doctor may control your blood pressure with||
2485|058|S|medication.||
2485|059|S|   Tell your doctor right away if you have any serious side||
2485|060|S|effects, including: blue fingers/toes, cold hands/feet.||
2485|061|S|   A very serious allergic reaction to this drug is rare.||
2485|062|S|However, get medical help right away if you notice any symptoms||
2485|063|S|of a serious allergic reaction, including: rash, itching/swelling||
2485|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2485|065|S|breathing.||
2485|066|S|   This is not a complete list of possible side effects. If you||
2485|067|S|notice other effects not listed above, contact your doctor or||
2485|068|S|pharmacist.||
2485|069|S|   In the US -||
2485|070|S|   Call your doctor for medical advice about side effects. You||
2485|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2485|072|S|www.fda.gov/medwatch.||
2485|073|S|   In Canada - Call your doctor for medical advice about side||
2485|074|S|effects. You may report side effects to Health Canada at||
2485|075|S|1-866-234-2345.||
2485|076|B|||
2485|077|P|PRECAUTIONS:  Before using zavegepant, tell your doctor or||
2485|078|P|pharmacist if you are allergic to it; or if you have any other||
2485|079|P|allergies. This product may contain inactive ingredients, which||
2485|080|P|can cause allergic reactions or other problems. Talk to your||
2485|081|P|pharmacist for more details.||
2485|082|P|   Before using this medication, tell your doctor or pharmacist||
2485|083|P|your medical history, especially of: blood circulation problems||
2485|084|P|(such as Raynaud's disease), high blood pressure.||
2485|085|P|   Before having surgery, tell your doctor or dentist about all||
2485|086|P|the products you use (including prescription drugs,||
2485|087|P|nonprescription drugs, and herbal products).||
2485|088|P|   During pregnancy, this medication should be used only when||
2485|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
2485|090|P|   It is unknown if this medication passes into breast milk.||
2485|091|P|Consult your doctor before breastfeeding.||
2485|092|B|||
2485|093|I|DRUG INTERACTIONS:  See also How to Use section.||
2485|094|I|   Drug interactions may change how your medications work or||
2485|095|I|increase your risk for serious side effects. This document does||
2485|096|I|not contain all possible drug interactions. Keep a list of all||
2485|097|I|the products you use (including prescription/nonprescription||
2485|098|I|drugs and herbal products) and share it with your doctor and||
2485|099|I|pharmacist. Do not start, stop, or change the dosage of any||
2485|100|I|medicines without your doctor's approval.||
2485|101|I|   Other medications can affect the removal of zavegepant from||
2485|102|I|your body, which may affect how zavegepant works. An example is||
2485|103|I|rifampin.||
2485|104|B|||
2485|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2485|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2485|107|O|poison control center right away. US residents can call||
2485|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2485|109|B|||
2485|110|N|NOTES:  Do not share this medication with others.||
2485|111|N|   Certain foods, beverages, or food additives (such as red wine,||
2485|112|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
2485|113|N|patterns such as irregular eating/sleeping habits or stress may||
2485|114|N|bring on a migraine. Avoiding these "triggers" may help lessen||
2485|115|N|migraine attacks. Consult your doctor for more details.||
2485|116|N|   Lab and/or medical tests (such as blood pressure) may be done||
2485|117|N|while you are using this medication. Keep all medical and lab||
2485|118|N|appointments. Consult your doctor for more details.||
2485|119|B|||
2485|120|D|MISSED DOSE:  Not applicable.||
2485|121|B|||
2485|122|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
2485|123|R|medications away from children and pets.||
2485|124|R|   Do not flush medications down the toilet or pour them into a||
2485|125|R|drain unless instructed to do so. Properly discard this product||
2485|126|R|when it is expired or no longer needed. Consult your pharmacist||
2485|127|R|or local waste disposal company.||
2485|128|B|||
2485|129|A|Information last revised March 2025.||
2485|130|A|Copyright(c) 2025 First Databank, Inc.||
2485|131|B|||
2486|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2486|002|Z|does NOT have all possible information about this product. This||
2486|003|Z|information does not assure that this product is safe, effective,||
2486|004|Z|or appropriate for you. This information is not individual||
2486|005|Z|medical advice and does not substitute for the advice of your||
2486|006|Z|health care professional. Always ask your health care||
2486|007|Z|professional for complete information about this product and your||
2486|008|Z|specific health needs.||
2486|009|B|||
2486|010|T|STIRIPENTOL - ORAL||
2486|011|F|(STIR-i-PEN-tol)||
2486|012|B|||
2486|013|C|COMMON BRAND NAME(S): Diacomit||
2486|014|B|||
2486|015|U|USES:  Stiripentol is used with other medications to treat a||
2486|016|U|certain inherited seizure disorder (Dravet syndrome). It belongs||
2486|017|U|to a class of drugs known as anticonvulsants.||
2486|018|B|||
2486|019|H|HOW TO USE:  Read the Medication Guide provided by your||
2486|020|H|pharmacist before you start taking stiripentol and each time you||
2486|021|H|get a refill. If you have any questions, ask your doctor or||
2486|022|H|pharmacist.||
2486|023|H|   Take this medication by mouth with food as directed by your||
2486|024|H|doctor, usually two to three times daily. If you are using the||
2486|025|H|capsule form of this medication, swallow the capsules whole. Do||
2486|026|H|not open or break the capsules.||
2486|027|H|   If you are using the powder form of this medication, read and||
2486|028|H|follow the Instructions for Use leaflet. Wash and dry your hands||
2486|029|H|before and after preparing each dose. Fill a glass with water (4||
2486|030|H|ounces or 100 milliliters). Open the packet(s) and pour the||
2486|031|H|prescribed dose into the glass. Stir gently with a spoon until||
2486|032|H|the powder dissolves completely. Drink all of the mixture right||
2486|033|H|away. Then add a small amount of water (1 ounce or 25||
2486|034|H|milliliters), stir again and drink right away to make sure you||
2486|035|H|are getting all of the drug. Do not prepare a supply in advance.||
2486|036|H|Ask your doctor or pharmacist if you have any questions.||
2486|037|H|   The dosage is based on your medical condition, response to||
2486|038|H|treatment, age, weight, and other medications you may be taking.||
2486|039|H|Be sure to tell your doctor and pharmacist about all the products||
2486|040|H|you use (including prescription drugs, nonprescription drugs, and||
2486|041|H|herbal products).||
2486|042|H|   To reduce your risk of side effects, your doctor may direct||
2486|043|H|you to start this medication at a low dose and gradually increase||
2486|044|H|your dose. Follow your doctor's instructions carefully.||
2486|045|H|   Use this medication regularly to get the most benefit from it.||
2486|046|H|To help you remember, take it at the same time(s) each day.||
2486|047|H|   Do not increase your dose or use this drug more often or for||
2486|048|H|longer than prescribed. Your condition will not improve any||
2486|049|H|faster, and your risk of side effects will increase.||
2486|050|H|   Do not stop taking this medication without consulting your||
2486|051|H|doctor. Some conditions (such as seizures) may become worse when||
2486|052|H|this drug is suddenly stopped. Your dose may need to be gradually||
2486|053|H|decreased.||
2486|054|H|   Tell your doctor if you do not get better or if you get worse.||
2486|055|B|||
2486|056|S|SIDE EFFECTS:  Dizziness, drowsiness, nausea, decreased appetite,||
2486|057|S|weight loss, or trouble sleeping may occur. If any of these||
2486|058|S|effects last or get worse, tell your doctor or pharmacist||
2486|059|S|promptly.||
2486|060|S|   Remember that this medication has been prescribed because your||
2486|061|S|doctor has judged that the benefit to you is greater than the||
2486|062|S|risk of side effects. Many people using this medication do not||
2486|063|S|have serious side effects.||
2486|064|S|   Tell your doctor right away if you have any serious side||
2486|065|S|effects, including: loss of coordination, trouble speaking,||
2486|066|S|tremor, mental/mood disorders (such as confusion, agitation,||
2486|067|S|aggression), easy bruising/bleeding, signs of infections (such as||
2486|068|S|sore throat that doesn't go away, fever, chills).||
2486|069|S|   A small number of people who take anticonvulsants for any||
2486|070|S|condition (such as seizure, bipolar disorder, pain) may||
2486|071|S|experience depression, suicidal thoughts/attempts, or other||
2486|072|S|mental/mood problems. Tell your doctor right away if you or your||
2486|073|S|family/caregiver notice any unusual/sudden changes in your mood,||
2486|074|S|thoughts, or behavior such as signs of depression, suicidal||
2486|075|S|thoughts/attempts, thoughts about harming yourself.||
2486|076|S|   A very serious allergic reaction to this drug is rare.||
2486|077|S|However, get medical help right away if you notice any symptoms||
2486|078|S|of a serious allergic reaction, including: rash, itching/swelling||
2486|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2486|080|S|breathing.||
2486|081|S|   This is not a complete list of possible side effects. If you||
2486|082|S|notice other effects not listed above, contact your doctor or||
2486|083|S|pharmacist.||
2486|084|S|   In the US -||
2486|085|S|   Call your doctor for medical advice about side effects. You||
2486|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2486|087|S|www.fda.gov/medwatch.||
2486|088|S|   In Canada - Call your doctor for medical advice about side||
2486|089|S|effects. You may report side effects to Health Canada at||
2486|090|S|1-866-234-2345.||
2486|091|B|||
2486|092|P|PRECAUTIONS:  Before taking stiripentol, tell your doctor or||
2486|093|P|pharmacist if you are allergic to it; or if you have any other||
2486|094|P|allergies. This product may contain inactive ingredients, which||
2486|095|P|can cause allergic reactions or other problems. Talk to your||
2486|096|P|pharmacist for more details.||
2486|097|P|   Before using this medication, tell your doctor or pharmacist||
2486|098|P|your medical history, especially of: liver disease, kidney||
2486|099|P|disease, mental/mood disorders (such as new or worsening||
2486|100|P|depression, confusion, suicidal thoughts, agitation).||
2486|101|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2486|102|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2486|103|P|machinery, or do anything that needs alertness until you can do||
2486|104|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2486|105|P|are using marijuana (cannabis).||
2486|106|P|   The powder form of this medication may contain aspartame. If||
2486|107|P|you have phenylketonuria (PKU) or any other condition that||
2486|108|P|requires you to limit/avoid aspartame (or phenylalanine) in your||
2486|109|P|diet, ask your doctor or pharmacist about using this medication||
2486|110|P|safely.||
2486|111|P|   Before having surgery, tell your doctor or dentist about all||
2486|112|P|the products you use (including prescription drugs,||
2486|113|P|nonprescription drugs, and herbal products).||
2486|114|P|   Children may be more sensitive to the side effects of this||
2486|115|P|drug, especially weight loss. This medication may slow down a||
2486|116|P|child's growth. Monitor your child's weight and height. Consult||
2486|117|P|your doctor or pharmacist for more details.||
2486|118|P|   During pregnancy, this medication should be used only when||
2486|119|P|clearly needed. It may harm an unborn baby. However, since||
2486|120|P|untreated seizures are a serious condition that can harm both a||
2486|121|P|pregnant woman and her unborn baby, do not stop taking this||
2486|122|P|medication unless directed by your doctor. Discuss the risks and||
2486|123|P|benefits with your doctor.||
2486|124|P|   It is unknown if this medication passes into breast milk.||
2486|125|P|Consult your doctor before breastfeeding.||
2486|126|B|||
2486|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2486|128|I|medications work or increase your risk for serious side effects.||
2486|129|I|This document does not contain all possible drug interactions.||
2486|130|I|Keep a list of all the products you use (including||
2486|131|I|prescription/nonprescription drugs and herbal products) and share||
2486|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
2486|133|I|the dosage of any medicines without your doctor's approval.||
2486|134|I|   This medication can slow down the removal of other medications||
2486|135|I|from your body, which may affect how they work. Examples of||
2486|136|I|affected drugs include flibanserin, lomitapide, among others.||
2486|137|I|   Tell your doctor or pharmacist if you are using other products||
2486|138|I|that cause drowsiness such as opioid pain or cough relievers||
2486|139|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2486|140|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2486|141|I|zolpidem), muscle relaxants (such as carisoprodol,||
2486|142|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2486|143|I|diphenhydramine).||
2486|144|I|   Check the labels on all your medicines (such as allergy or||
2486|145|I|cough-and-cold products) because they may contain ingredients||
2486|146|I|that cause drowsiness. Ask your pharmacist about using those||
2486|147|I|products safely.||
2486|148|B|||
2486|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2486|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2486|151|O|poison control center right away. US residents can call||
2486|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2486|153|B|||
2486|154|N|NOTES:  Do not share this medication with others.||
2486|155|N|   Lab and/or medical tests (such as complete blood count,||
2486|156|N|liver/kidney function, height/weight measurements) should be done||
2486|157|N|before you start taking this medication and while you are taking||
2486|158|N|it. Keep all medical and lab appointments. Consult your doctor||
2486|159|N|for more details.||
2486|160|B|||
2486|161|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2486|162|D|remember. If it is near the time of the next dose, skip the||
2486|163|D|missed dose. Take your next dose at the regular time. Do not||
2486|164|D|double the dose to catch up.||
2486|165|B|||
2486|166|R|STORAGE:  Store in the original container at room temperature||
2486|167|R|away from light and moisture. Do not store in the bathroom. Keep||
2486|168|R|all medications away from children and pets.||
2486|169|R|   Do not flush medications down the toilet or pour them into a||
2486|170|R|drain unless instructed to do so. Properly discard this product||
2486|171|R|when it is expired or no longer needed. Consult your pharmacist||
2486|172|R|or local waste disposal company.||
2486|173|B|||
2486|174|M|MEDICAL ALERT:  Your condition can cause complications in a||
2486|175|M|medical emergency. For information about enrolling in MedicAlert,||
2486|176|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2486|177|B|||
2486|178|A|Information last revised August 2025.||
2486|179|A|Copyright(c) 2025 First Databank, Inc.||
2486|180|B|||
2487|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2487|002|Z|does NOT have all possible information about this product. This||
2487|003|Z|information does not assure that this product is safe, effective,||
2487|004|Z|or appropriate for you. This information is not individual||
2487|005|Z|medical advice and does not substitute for the advice of your||
2487|006|Z|health care professional. Always ask your health care||
2487|007|Z|professional for complete information about this product and your||
2487|008|Z|specific health needs.||
2487|009|B|||
2487|010|T|CRIZANLIZUMAB - INJECTION||
2487|011|F|(KRIZ-an-LIZ-ue-mab)||
2487|012|B|||
2487|013|C|COMMON BRAND NAME(S): Adakveo||
2487|014|B|||
2487|015|U|USES:  Crizanlizumab is used by people with sickle cell disease||
2487|016|U|to reduce the number of painful crises caused by the disease. It||
2487|017|U|works by attaching to a certain substance in your body||
2487|018|U|(P-selectin) and preventing blood cells from sticking together.||
2487|019|U|Crizanlizumab belongs to a class of drugs known as monoclonal||
2487|020|U|antibodies.||
2487|021|B|||
2487|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2487|023|H|from your pharmacist before you start using crizanlizumab and||
2487|024|H|each time you get an infusion. If you have any questions, ask||
2487|025|H|your doctor or pharmacist.||
2487|026|H|   This medication is given by a health care professional. It is||
2487|027|H|given as directed by your doctor on a treatment schedule. It is||
2487|028|H|injected slowly into a vein usually over 30 minutes. The first 2||
2487|029|H|infusions are usually given 2 weeks apart. After that, an||
2487|030|H|infusion is usually given every 4 weeks. Follow your doctor's||
2487|031|H|treatment schedule.||
2487|032|H|   Infusion reactions may happen during the infusion of this drug||
2487|033|H|and for up to 24 hours afterward. Your doctor may prescribe other||
2487|034|H|medications (such as acetaminophen, nonsteroidal||
2487|035|H|anti-inflammatory drugs-NSAIDs, antihistamines) before each||
2487|036|H|treatment to help prevent these side effects. Tell your doctor||
2487|037|H|right away if you have symptoms of infusion reactions such as||
2487|038|H|pain, headache, dizziness, fever, chills, shivering, nausea,||
2487|039|H|vomiting, diarrhea, itching, or trouble breathing. Your doctor||
2487|040|H|may slow down or stop your treatment for some time.||
2487|041|H|   The dosage and treatment schedule are based on your medical||
2487|042|H|condition, weight, and response to treatment. Use this medication||
2487|043|H|regularly to get the most benefit from it. To help you remember,||
2487|044|H|mark your calendar with a reminder.||
2487|045|B|||
2487|046|S|SIDE EFFECTS:  See also How to Use section.||
2487|047|S|   Nausea, stomach pain, fever, or joint/back pain may occur. If||
2487|048|S|any of these effects last or get worse, tell your doctor or||
2487|049|S|pharmacist promptly.||
2487|050|S|   Remember that this medication has been prescribed because your||
2487|051|S|doctor has judged that the benefit to you is greater than the||
2487|052|S|risk of side effects. Many people using this medication do not||
2487|053|S|have serious side effects.||
2487|054|S|   A very serious allergic reaction to this drug is rare.||
2487|055|S|However, get medical help right away if you notice any symptoms||
2487|056|S|of a serious allergic reaction, including: rash, itching/swelling||
2487|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2487|058|S|breathing.||
2487|059|S|   This is not a complete list of possible side effects. If you||
2487|060|S|notice other effects not listed above, contact your doctor or||
2487|061|S|pharmacist.||
2487|062|S|   In the US -||
2487|063|S|   Call your doctor for medical advice about side effects. You||
2487|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2487|065|S|www.fda.gov/medwatch.||
2487|066|S|   In Canada - Call your doctor for medical advice about side||
2487|067|S|effects. You may report side effects to Health Canada at||
2487|068|S|1-866-234-2345.||
2487|069|B|||
2487|070|P|PRECAUTIONS:  Before using crizanlizumab, tell your doctor or||
2487|071|P|pharmacist if you are allergic to it; or if you have any other||
2487|072|P|allergies. This product may contain inactive ingredients, which||
2487|073|P|can cause allergic reactions or other problems. Talk to your||
2487|074|P|pharmacist for more details.||
2487|075|P|   Before using this medication, tell your doctor or pharmacist||
2487|076|P|your medical history.||
2487|077|P|   Before having surgery, tell your doctor or dentist about all||
2487|078|P|the products you use (including prescription drugs,||
2487|079|P|nonprescription drugs, and herbal products).||
2487|080|P|   Tell your doctor if you are pregnant or plan to become||
2487|081|P|pregnant. You should not become pregnant while using||
2487|082|P|crizanlizumab. Crizanlizumab may harm an unborn baby. If you||
2487|083|P|become pregnant, talk to your doctor right away about the risks||
2487|084|P|and benefits of this medication.||
2487|085|P|   It is unknown if this medication passes into breast milk.||
2487|086|P|Consult your doctor before breastfeeding.||
2487|087|B|||
2487|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2487|089|I|medications work or increase your risk for serious side effects.||
2487|090|I|This document does not contain all possible drug interactions.||
2487|091|I|Keep a list of all the products you use (including||
2487|092|I|prescription/nonprescription drugs and herbal products) and share||
2487|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
2487|094|I|the dosage of any medicines without your doctor's approval.||
2487|095|I|   This medication may interfere with certain lab tests (such as||
2487|096|I|platelet counts), possibly causing false test results. Make sure||
2487|097|I|lab personnel and all your doctors know you use this drug.||
2487|098|B|||
2487|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2487|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2487|101|O|poison control center right away. US residents can call||
2487|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2487|103|B|||
2487|104|N|NOTES:  Keep all medical and lab appointments.||
2487|105|B|||
2487|106|D|MISSED DOSE:  It is important to get each dose of this medication||
2487|107|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2487|108|D|right away for a new dosing schedule.||
2487|109|B|||
2487|110|R|STORAGE:  Not applicable. This medication is given in a hospital||
2487|111|R|or clinic or doctor's office and will not be stored at home.||
2487|112|B|||
2487|113|A|Information last revised October 2024.||
2487|114|A|Copyright(c) 2025 First Databank, Inc.||
2487|115|B|||
2488|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2488|002|Z|does NOT have all possible information about this product. This||
2488|003|Z|information does not assure that this product is safe, effective,||
2488|004|Z|or appropriate for you. This information is not individual||
2488|005|Z|medical advice and does not substitute for the advice of your||
2488|006|Z|health care professional. Always ask your health care||
2488|007|Z|professional for complete information about this product and your||
2488|008|Z|specific health needs.||
2488|009|B|||
2488|010|T|TROFINETIDE - ORAL||
2488|011|F|(troe-FIN-e-tide)||
2488|012|B|||
2488|013|C|COMMON BRAND NAME(S): Daybue||
2488|014|B|||
2488|015|U|USES:  This medication is used to treat a certain rare genetic||
2488|016|U|disorder (Rett syndrome). This disorder affects the development||
2488|017|U|of the brain. Trofinetide may help lessen the symptoms of Rett||
2488|018|U|syndrome.||
2488|019|B|||
2488|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2488|021|H|from your pharmacist before you start taking trofinetide and each||
2488|022|H|time you get a refill. If you have any questions, ask your doctor||
2488|023|H|or pharmacist.||
2488|024|H|   Take this medication by mouth or through a feeding tube with||
2488|025|H|or without food as directed by your doctor, usually twice daily.||
2488|026|H|Carefully measure the dose using a special measuring||
2488|027|H|device/spoon. Do not use a household spoon because you may not||
2488|028|H|get the correct dose.||
2488|029|H|   The dosage is based on your medical condition, weight, and||
2488|030|H|response to treatment.||
2488|031|H|   If you are taking a laxative, your doctor may direct you to||
2488|032|H|stop the laxative before starting trofinetide. Consult your||
2488|033|H|doctor or pharmacist for more details.||
2488|034|H|   If you vomit after taking your dose of trofinetide, do not||
2488|035|H|take an additional dose. Take your next dose at the regular||
2488|036|H|scheduled time. Do not take two doses at the same time.||
2488|037|H|   Use this medication regularly to get the most benefit from it.||
2488|038|H|To help you remember, take it at the same times each day.||
2488|039|H|   Do not increase your dose or use this drug more often or for||
2488|040|H|longer than prescribed. Your condition will not improve any||
2488|041|H|faster, and your risk of side effects will increase.||
2488|042|H|   Tell your doctor if your condition gets worse.||
2488|043|B|||
2488|044|S|SIDE EFFECTS:  Vomiting or weight loss may occur. If either of||
2488|045|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2488|046|S|promptly.||
2488|047|S|   Diarrhea is a common side effect that can cause dehydration.||
2488|048|S|Tell your doctor promptly if you have diarrhea. Drink plenty of||
2488|049|S|fluids to reduce the risk of dehydration. Your doctor may||
2488|050|S|prescribe medications to control the diarrhea or stop/adjust the||
2488|051|S|dose of trofinetide. Tell your doctor right away if you develop||
2488|052|S|signs of dehydration (such as unusual decreased urination,||
2488|053|S|unusual dry mouth/thirst, fast heartbeat,||
2488|054|S|dizziness/lightheadedness).||
2488|055|S|   Remember that this medication has been prescribed because your||
2488|056|S|doctor has judged that the benefit to you is greater than the||
2488|057|S|risk of side effects. Many people using this medication do not||
2488|058|S|have serious side effects.||
2488|059|S|   A very serious allergic reaction to this drug is rare.||
2488|060|S|However, get medical help right away if you notice any symptoms||
2488|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2488|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2488|063|S|breathing.||
2488|064|S|   This is not a complete list of possible side effects. If you||
2488|065|S|notice other effects not listed above, contact your doctor or||
2488|066|S|pharmacist.||
2488|067|S|   In the US -||
2488|068|S|   Call your doctor for medical advice about side effects. You||
2488|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2488|070|S|www.fda.gov/medwatch.||
2488|071|S|   In Canada - Call your doctor for medical advice about side||
2488|072|S|effects. You may report side effects to Health Canada at||
2488|073|S|1-866-234-2345.||
2488|074|B|||
2488|075|P|PRECAUTIONS:  Before taking trofinetide, tell your doctor or||
2488|076|P|pharmacist if you are allergic to it; or if you have any other||
2488|077|P|allergies. This product may contain inactive ingredients, which||
2488|078|P|can cause allergic reactions or other problems. Talk to your||
2488|079|P|pharmacist for more details.||
2488|080|P|   Before using this medication, tell your doctor or pharmacist||
2488|081|P|your medical history, especially of: kidney disease.||
2488|082|P|   Before having surgery, tell your doctor or dentist about all||
2488|083|P|the products you use (including prescription drugs,||
2488|084|P|nonprescription drugs, and herbal products).||
2488|085|P|   During pregnancy, this medication should be used only when||
2488|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
2488|087|P|   It is unknown if this medication passes into breast milk.||
2488|088|P|Consult your doctor before breastfeeding.||
2488|089|B|||
2488|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2488|091|I|medications work or increase your risk for serious side effects.||
2488|092|I|This document does not contain all possible drug interactions.||
2488|093|I|Keep a list of all the products you use (including||
2488|094|I|prescription/nonprescription drugs and herbal products) and share||
2488|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
2488|096|I|the dosage of any medicines without your doctor's approval.||
2488|097|B|||
2488|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2488|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2488|100|O|poison control center right away. US residents can call||
2488|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2488|102|B|||
2488|103|N|NOTES:  Do not share this medication with others.||
2488|104|N|   Lab and/or medical tests (such as weight) should be done||
2488|105|N|before you start taking this medication and while you are taking||
2488|106|N|it. Keep all medical and lab appointments. Consult your doctor||
2488|107|N|for more details.||
2488|108|B|||
2488|109|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2488|110|D|next dose at the regular time. Do not double the dose to catch||
2488|111|D|up.||
2488|112|B|||
2488|113|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2488|114|R|bottle tightly closed and in an upright position. Once the bottle||
2488|115|R|is opened, this medication expires after 14 days. Keep all||
2488|116|R|medications away from children and pets.||
2488|117|R|   Do not flush medications down the toilet or pour them into a||
2488|118|R|drain unless instructed to do so. Properly discard this product||
2488|119|R|when it is expired or no longer needed. Consult your pharmacist||
2488|120|R|or local waste disposal company.||
2488|121|B|||
2488|122|A|Information last revised September 2024.||
2488|123|A|Copyright(c) 2025 First Databank, Inc.||
2488|124|B|||
2489|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2489|002|Z|does NOT have all possible information about this product. This||
2489|003|Z|information does not assure that this product is safe, effective,||
2489|004|Z|or appropriate for you. This information is not individual||
2489|005|Z|medical advice and does not substitute for the advice of your||
2489|006|Z|health care professional. Always ask your health care||
2489|007|Z|professional for complete information about this product and your||
2489|008|Z|specific health needs.||
2489|009|B|||
2489|010|T|RETIFANLIMAB - INJECTION||
2489|011|F|(RE-ti-FAN-li-mab)||
2489|012|B|||
2489|013|C|COMMON BRAND NAME(S): Zynyz||
2489|014|B|||
2489|015|U|USES:  Retifanlimab is used to treat certain types of cancer||
2489|016|U|(such as Merkel cell carcinoma-MCC, squamous cell carcinoma). It||
2489|017|U|works by changing the action of your own immune system, directing||
2489|018|U|it to attack cancer cells. Retifanlimab belongs to a class of||
2489|019|U|drugs known as monoclonal antibodies.||
2489|020|B|||
2489|021|H|HOW TO USE:  Read the Medication Guide provided by your||
2489|022|H|pharmacist before you start receiving retifanlimab and each time||
2489|023|H|you get a treatment. If you have any questions, ask your doctor||
2489|024|H|or pharmacist.||
2489|025|H|   This medication is given by a health care professional. It is||
2489|026|H|injected slowly into a vein over 30 minutes. It is given as||
2489|027|H|directed by your doctor, usually once every 4 weeks.||
2489|028|H|   Infusion reactions may happen during the infusion of this||
2489|029|H|drug. Tell your doctor right away if you have symptoms of||
2489|030|H|infusion reaction such as nausea, fever, chills, flushing,||
2489|031|H|shortness of breath, dizziness, or fainting. Your doctor may give||
2489|032|H|you other medications to help with these side effects or may stop||
2489|033|H|your treatment for some time.||
2489|034|B|||
2489|035|S|SIDE EFFECTS:  See also How to Use section.||
2489|036|S|   Diarrhea, nausea, or decreased appetite may occur. If any of||
2489|037|S|these effects last or get worse, tell your doctor or pharmacist||
2489|038|S|promptly.||
2489|039|S|   People using this medication may have serious side effects.||
2489|040|S|However, you have been prescribed this drug because your doctor||
2489|041|S|has judged that the benefit to you is greater than the risk of||
2489|042|S|side effects. Careful monitoring by your doctor may decrease your||
2489|043|S|risk.||
2489|044|S|   Tell your doctor right away if you have any serious side||
2489|045|S|effects, including: new/worsening cough, diarrhea with||
2489|046|S|blood/mucus, severe stomach/abdominal pain, mouth/throat sores,||
2489|047|S|symptoms of liver disease (such as nausea/vomiting that doesn't||
2489|048|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
2489|049|S|eyes/skin, dark urine), signs of kidney problems (such as change||
2489|050|S|in the amount of urine, pink/bloody urine), easy||
2489|051|S|bruising/bleeding, swelling hands/ankles/feet, unusual weakness,||
2489|052|S|joint stiffness/pain, muscle||
2489|053|S|weakness/tenderness/pain/spasms/cramps, numbness/tingling of||
2489|054|S|arms/legs, loss of coordination, eye redness/pain/sensitivity to||
2489|055|S|light, vision changes, headache that is unusual or doesn't go||
2489|056|S|away, seizures.||
2489|057|S|   Retifanlimab may cause hormone gland problems (such as||
2489|058|S|thyroid, pituitary, adrenal, pancreas). Your body could make too||
2489|059|S|much or too little hormone. Tell your doctor right away if you||
2489|060|S|have any symptoms such as: cold or heat intolerance, unexplained||
2489|061|S|weight loss/gain, increased thirst/urination, mood or behavior||
2489|062|S|changes (such as decreased sex drive, irritability,||
2489|063|S|forgetfulness), slow/fast/pounding/irregular heartbeat, unusual||
2489|064|S|tiredness, constipation.||
2489|065|S|   Get medical help right away if you have any very serious side||
2489|066|S|effects, including: chest pain, shortness of breath.||
2489|067|S|   Retifanlimab can commonly cause itching or a rash that is||
2489|068|S|usually not serious. However, you may not be able to tell it||
2489|069|S|apart from a rare rash that could be a sign of a severe reaction.||
2489|070|S|Get medical help right away if you develop any rash or itching.||
2489|071|S|   A very serious allergic reaction to this drug is rare.||
2489|072|S|However, get medical help right away if you notice any symptoms||
2489|073|S|of a serious allergic reaction, including: fever, swollen lymph||
2489|074|S|nodes, rash, itching/swelling (especially of the||
2489|075|S|face/tongue/throat), severe dizziness, trouble breathing.||
2489|076|S|   This is not a complete list of possible side effects. If you||
2489|077|S|notice other effects not listed above, contact your doctor or||
2489|078|S|pharmacist.||
2489|079|S|   In the US -||
2489|080|S|   Call your doctor for medical advice about side effects. You||
2489|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2489|082|S|www.fda.gov/medwatch.||
2489|083|S|   In Canada - Call your doctor for medical advice about side||
2489|084|S|effects. You may report side effects to Health Canada at||
2489|085|S|1-866-234-2345.||
2489|086|B|||
2489|087|P|PRECAUTIONS:  Before using retifanlimab, tell your doctor or||
2489|088|P|pharmacist if you are allergic to it; or if you have any other||
2489|089|P|allergies. This product may contain inactive ingredients, which||
2489|090|P|can cause allergic reactions or other problems. Talk to your||
2489|091|P|pharmacist for more details.||
2489|092|P|   Before using this medication, tell your doctor or pharmacist||
2489|093|P|your medical history, especially of: organ transplant, radiation||
2489|094|P|treatment, stem cell transplant with donor cells.||
2489|095|P|   Before having surgery, tell your doctor or dentist about all||
2489|096|P|the products you use (including prescription drugs,||
2489|097|P|nonprescription drugs, and herbal products).||
2489|098|P|   Tell your doctor if you are pregnant or plan to become||
2489|099|P|pregnant. You should not become pregnant while using||
2489|100|P|retifanlimab. Retifanlimab may harm an unborn baby. Your doctor||
2489|101|P|should order a pregnancy test before you start this medication.||
2489|102|P|Ask about reliable forms of birth control while using this||
2489|103|P|medication and for 4 months after the last dose. If you become||
2489|104|P|pregnant, talk to your doctor right away about the risks and||
2489|105|P|benefits of this medication.||
2489|106|P|   It is unknown if this drug passes into breast milk. Because of||
2489|107|P|the possible risk to the infant, breastfeeding is not recommended||
2489|108|P|while using this drug and for 4 months after the last dose.||
2489|109|P|Consult your doctor before breastfeeding.||
2489|110|B|||
2489|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2489|112|I|medications work or increase your risk for serious side effects.||
2489|113|I|This document does not contain all possible drug interactions.||
2489|114|I|Keep a list of all the products you use (including||
2489|115|I|prescription/nonprescription drugs and herbal products) and share||
2489|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
2489|117|I|the dosage of any medicines without your doctor's approval.||
2489|118|B|||
2489|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2489|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2489|121|O|poison control center right away. US residents can call||
2489|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2489|123|B|||
2489|124|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
2489|125|N|function, blood sugar) should be done before you start using this||
2489|126|N|medication and while you are using it. Keep all medical and lab||
2489|127|N|appointments. Consult your doctor for more details.||
2489|128|B|||
2489|129|D|MISSED DOSE:  It is important to get each dose of this medication||
2489|130|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2489|131|D|right away for a new dosing schedule.||
2489|132|B|||
2489|133|R|STORAGE:  Not applicable. This medication is given in a hospital||
2489|134|R|or clinic and will not be stored at home.||
2489|135|B|||
2489|136|A|Information last revised May 2025.||
2489|137|A|Copyright(c) 2025 First Databank, Inc.||
2489|138|B|||
2490|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2490|002|Z|does NOT have all possible information about this product. This||
2490|003|Z|information does not assure that this product is safe, effective,||
2490|004|Z|or appropriate for you. This information is not individual||
2490|005|Z|medical advice and does not substitute for the advice of your||
2490|006|Z|health care professional. Always ask your health care||
2490|007|Z|professional for complete information about this product and your||
2490|008|Z|specific health needs.||
2490|009|B|||
2490|010|T|SEBELIPASE ALFA - INJECTION||
2490|011|F|(SE-be-LYE-pase AL-fa)||
2490|012|B|||
2490|013|C|COMMON BRAND NAME(S): Kanuma||
2490|014|B|||
2490|015|W|WARNING:  Sebelipase alfa may cause serious (sometimes fatal)||
2490|016|W|allergic reactions. Get medical help right away if you have any||
2490|017|W|symptoms of a serious allergic reaction such as rash,||
2490|018|W|itching/swelling (especially of the face/tongue/throat), severe||
2490|019|W|dizziness, trouble breathing, chest pain, fast heartbeat, stomach||
2490|020|W|pain, mental/mood changes, fever, chills, or nausea.||
2490|021|B|||
2490|022|U|USES:  This medication is used to treat a certain rare genetic||
2490|023|U|problem (lysosomal acid lipase deficiency LAL-D). Sebelipase alfa||
2490|024|U|replaces a certain natural substance (an enzyme called lysosomal||
2490|025|U|acid lipase) that is missing in people with LAL-D. This helps the||
2490|026|U|body to breakdown fats. High fat levels can lead to liver damage||
2490|027|U|or high blood cholesterol levels.||
2490|028|B|||
2490|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2490|030|H|from your pharmacist before you start using sebelipase alfa and||
2490|031|H|each time you get an infusion. If you have any questions, ask||
2490|032|H|your doctor or pharmacist.||
2490|033|H|   This medication is given by injection into a vein as directed||
2490|034|H|by your doctor, usually once every week or once every other week.||
2490|035|H|The injection is given by a health care professional, usually||
2490|036|H|over 2 hours. The dosage is based on your medical condition, age,||
2490|037|H|weight, and response to treatment.||
2490|038|H|   Use this medication regularly to get the most benefit from it.||
2490|039|H|To help you remember, mark your calendar with a reminder.||
2490|040|H|   Tell your doctor if your condition gets worse.||
2490|041|B|||
2490|042|S|SIDE EFFECTS:  See also Warning section.||
2490|043|S|   Headache, dizziness, or cold symptoms (such as runny/stuffy||
2490|044|S|nose, cough, sneezing) may occur. If any of these effects last or||
2490|045|S|get worse, tell your doctor or pharmacist promptly.||
2490|046|S|   Remember that this medication has been prescribed because your||
2490|047|S|doctor has judged that the benefit to you is greater than the||
2490|048|S|risk of side effects. Many people using this medication do not||
2490|049|S|have serious side effects.||
2490|050|S|   This is not a complete list of possible side effects. If you||
2490|051|S|notice other effects not listed above, contact your doctor or||
2490|052|S|pharmacist.||
2490|053|S|   In the US -||
2490|054|S|   Call your doctor for medical advice about side effects. You||
2490|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2490|056|S|www.fda.gov/medwatch.||
2490|057|S|   In Canada - Call your doctor for medical advice about side||
2490|058|S|effects. You may report side effects to Health Canada at||
2490|059|S|1-866-234-2345.||
2490|060|B|||
2490|061|P|PRECAUTIONS:  Before using sebelipase alfa, tell your doctor or||
2490|062|P|pharmacist if you are allergic to it; or to egg products; or if||
2490|063|P|you have any other allergies. This product may contain inactive||
2490|064|P|ingredients, which can cause allergic reactions or other||
2490|065|P|problems. Talk to your pharmacist for more details.||
2490|066|P|   Before using this medication, tell your doctor or pharmacist||
2490|067|P|your medical history.||
2490|068|P|   This drug may rarely make you dizzy. Alcohol or marijuana||
2490|069|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
2490|070|P|or do anything that needs alertness until you can do it safely.||
2490|071|P|Limit alcoholic beverages. Talk to your doctor if you are using||
2490|072|P|marijuana (cannabis).||
2490|073|P|   Before having surgery, tell your doctor or dentist about all||
2490|074|P|the products you use (including prescription drugs,||
2490|075|P|nonprescription drugs, and herbal products).||
2490|076|P|   During pregnancy, this medication should be used only when||
2490|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
2490|078|P|   It is unknown if this medication passes into breast milk.||
2490|079|P|Consult your doctor before breastfeeding.||
2490|080|B|||
2490|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2490|082|I|medications work or increase your risk for serious side effects.||
2490|083|I|This document does not contain all possible drug interactions.||
2490|084|I|Keep a list of all the products you use (including||
2490|085|I|prescription/nonprescription drugs and herbal products) and share||
2490|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
2490|087|I|the dosage of any medicines without your doctor's approval.||
2490|088|B|||
2490|089|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2490|090|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2490|091|O|poison control center right away. US residents can call||
2490|092|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2490|093|B|||
2490|094|N|NOTES:  Lab and/or medical tests (such as||
2490|095|N|cholesterol/triglyceride levels, liver function, height, weight)||
2490|096|N|should be done before you start using this medication and while||
2490|097|N|you are using it. Keep all medical and lab appointments. Consult||
2490|098|N|your doctor for more details.||
2490|099|B|||
2490|100|D|MISSED DOSE:  It is important to get each dose of this medication||
2490|101|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2490|102|D|right away for a new dosing schedule.||
2490|103|B|||
2490|104|R|STORAGE:  Not applicable. This medication is given in a hospital||
2490|105|R|or clinic and will not be stored at home.||
2490|106|B|||
2490|107|A|Information last revised October 2024.||
2490|108|A|Copyright(c) 2025 First Databank, Inc.||
2490|109|B|||
2491|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2491|002|Z|does NOT have all possible information about this product. This||
2491|003|Z|information does not assure that this product is safe, effective,||
2491|004|Z|or appropriate for you. This information is not individual||
2491|005|Z|medical advice and does not substitute for the advice of your||
2491|006|Z|health care professional. Always ask your health care||
2491|007|Z|professional for complete information about this product and your||
2491|008|Z|specific health needs.||
2491|009|B|||
2491|010|T|VILOBELIMAB - INJECTION||
2491|011|F|(VIL-oh-BEL-i-mab)||
2491|012|B|||
2491|013|C|COMMON BRAND NAME(S): Gohibic||
2491|014|B|||
2491|015|U|USES:  Vilobelimab is a medication that the FDA is allowing to be||
2491|016|U|given for emergency use to treat COVID-19. It is used to treat||
2491|017|U|people who are in the hospital and unable to breathe on their own||
2491|018|U|(for example, being on a mechanical ventilator). Talk to your||
2491|019|U|doctor about the risks and benefits of treatment with||
2491|020|U|vilobelimab.||
2491|021|U|   Vilobelimab belongs to a class of drugs known as monoclonal||
2491|022|U|antibodies. It works by blocking the effects of a protein in the||
2491|023|U|body's immune system that causes inflammation. This effect may||
2491|024|U|prevent worsening of COVID-19. More information about vilobelimab||
2491|025|U|is available from the FDA Fact Sheet for Patients and Caregivers||
2491|026|U|provided by your health care professional. If you are enrolled in||
2491|027|U|a study, information should be provided by the doctor via the||
2491|028|U|Informed Consent Form.||
2491|029|U|   There is limited information about how safe and effective||
2491|030|U|vilobelimab is for treating COVID-19. Study results show that||
2491|031|U|vilobelimab may help decrease risk of death in certain people||
2491|032|U|with COVID-19 who are in the hospital.||
2491|033|U|   The information in this document reflects emerging data, which||
2491|034|U|is evolving and subject to reassessment. Users should be aware of||
2491|035|U|these considerations in their review of vilobelimab, and it is||
2491|036|U|always the responsibility of treating practitioners to exercise||
2491|037|U|independent judgment in making care decisions.||
2491|038|B|||
2491|039|H|HOW TO USE:  This medication is given by slow injection into a||
2491|040|H|vein as directed by your doctor. It is infused by a health care||
2491|041|H|professional usually over 30 to 60 minutes. Your doctor may||
2491|042|H|direct you to receive up to 6 doses of this medication on certain||
2491|043|H|days while you are in the hospital.||
2491|044|H|   The number of doses you receive depends on your medical||
2491|045|H|condition and response to treatment.||
2491|046|H|   Tell your doctor if your condition does not get better or if||
2491|047|H|it gets worse.||
2491|048|B|||
2491|049|S|SIDE EFFECTS:  Although vilobelimab is used to treat COVID-19,||
2491|050|S|there have been cases of other serious infections reported. Tell||
2491|051|S|your doctor right away if you have any new or worsening signs of||
2491|052|S|infection (such as sore throat that doesn't go away, fever,||
2491|053|S|chills, painful urination, sores around the mouth/genitals).||
2491|054|S|   A very serious allergic reaction to this drug is rare.||
2491|055|S|However, get medical help right away if you notice any symptoms||
2491|056|S|of a serious allergic reaction, including: rash, itching/swelling||
2491|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2491|058|S|breathing.||
2491|059|S|   Information is limited and it is unknown at this time if||
2491|060|S|vilobelimab causes other serious side effects. This is not||
2491|061|S|necessarily a complete list of possible side effects.||
2491|062|S|   Contact your doctor for medical advice about side effects.||
2491|063|B|||
2491|064|P|PRECAUTIONS:  Before using this medication, tell your doctor if||
2491|065|P|you have any allergies. Vilobelimab may contain inactive||
2491|066|P|ingredients, which can cause allergic reactions or other||
2491|067|P|problems.||
2491|068|P|   Limited information is known at this time about other medical||
2491|069|P|conditions that may affect how vilobelimab works, or how||
2491|070|P|vilobelimab may affect other medical conditions.||
2491|071|P|   Before using this medication, tell your doctor your medical||
2491|072|P|history.||
2491|073|P|   To avoid spreading the virus, you should continue to take||
2491|074|P|precautions such as self-isolation, wearing a mask, social||
2491|075|P|distancing (physical distancing), washing hands, and not sharing||
2491|076|P|personal items.||
2491|077|P|   Tell your doctor if you are pregnant or think you are||
2491|078|P|pregnant. Vilobelimab should be used during pregnancy only if the||
2491|079|P|possible benefits are greater than the possible risks.||
2491|080|P|   It is unknown if vilobelimab passes into breast milk. Consult||
2491|081|P|your doctor before breastfeeding.||
2491|082|B|||
2491|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2491|084|I|medications work or increase your risk for serious side effects.||
2491|085|I|Information is limited and it is unknown at this time if||
2491|086|I|vilobelimab has drug interactions. Keep a list of all the||
2491|087|I|products you use (including prescription/nonprescription drugs||
2491|088|I|and herbal products) and share it with your doctor and||
2491|089|I|pharmacist. Do not start, stop, or change the dosage of any||
2491|090|I|medicines without your doctor's approval.||
2491|091|B|||
2491|092|O|OVERDOSE:  Overdose information is not available at this time.||
2491|093|B|||
2491|094|N|NOTES:  Not applicable.||
2491|095|B|||
2491|096|D|MISSED DOSE:  Not applicable.||
2491|097|B|||
2491|098|R|STORAGE:  Not applicable. This medication is given in a hospital||
2491|099|R|and will not be stored at home.||
2491|100|B|||
2491|101|A|Information last revised April 2025.||
2491|102|A|Copyright(c) 2025 First Databank, Inc.||
2491|103|B|||
2492|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2492|002|Z|does NOT have all possible information about this product. This||
2492|003|Z|information does not assure that this product is safe, effective,||
2492|004|Z|or appropriate for you. This information is not individual||
2492|005|Z|medical advice and does not substitute for the advice of your||
2492|006|Z|health care professional. Always ask your health care||
2492|007|Z|professional for complete information about this product and your||
2492|008|Z|specific health needs.||
2492|009|B|||
2492|010|T|PALIFERMIN - INJECTION||
2492|011|F|(PAL-ee-FER-min)||
2492|012|B|||
2492|013|C|COMMON BRAND NAME(S): Kepivance||
2492|014|B|||
2492|015|U|USES:  Palifermin is used by people with blood or bone marrow||
2492|016|U|cancer (such as leukemia, multiple myeloma) who are receiving||
2492|017|U|chemotherapy or radiation along with stem cell transplant. The||
2492|018|U|chemotherapy or radiation can cause severe sores in the mouth and||
2492|019|U|throat (mucositis). Palifermin is used to decrease the risk of||
2492|020|U|these sores and to decrease the time it takes for these sores to||
2492|021|U|heal. Palifermin may work by increasing the growth of cells in||
2492|022|U|the mouth and throat.||
2492|023|U|   This medication should only be used by patients with blood or||
2492|024|U|bone marrow cancer, and not by patients with other types of||
2492|025|U|cancer.||
2492|026|B|||
2492|027|H|HOW TO USE:  This medication is given by injection into a vein by||
2492|028|H|a health care professional as directed by your doctor. It is||
2492|029|H|usually given daily for 3 days in a row before the cancer||
2492|030|H|treatment and daily for 3 days in a row after the cancer||
2492|031|H|treatment. The doses must be given at least 24 hours before and||
2492|032|H|at least 24 hours after the cancer treatment. The dosage is based||
2492|033|H|on your weight.||
2492|034|H|   Tell your doctor if your condition does not get better or if||
2492|035|H|it gets worse.||
2492|036|B|||
2492|037|S|SIDE EFFECTS:  Numbness/tingling or increased sensitivity around||
2492|038|S|the mouth/tongue, change in tongue color, or change in taste may||
2492|039|S|occur. If any of these effects last or get worse, tell your||
2492|040|S|doctor or pharmacist promptly.||
2492|041|S|   Remember that this medication has been prescribed because your||
2492|042|S|doctor has judged that the benefit to you is greater than the||
2492|043|S|risk of side effects. Many people using this medication do not||
2492|044|S|have serious side effects.||
2492|045|S|   A very serious allergic reaction to this drug is rare.||
2492|046|S|However, get medical help right away if you notice any symptoms||
2492|047|S|of a serious allergic reaction, including: rash, itching/swelling||
2492|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2492|049|S|breathing.||
2492|050|S|   This is not a complete list of possible side effects. If you||
2492|051|S|notice other effects not listed above, contact your doctor or||
2492|052|S|pharmacist.||
2492|053|S|   In the US -||
2492|054|S|   Call your doctor for medical advice about side effects. You||
2492|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2492|056|S|www.fda.gov/medwatch.||
2492|057|S|   In Canada - Call your doctor for medical advice about side||
2492|058|S|effects. You may report side effects to Health Canada at||
2492|059|S|1-866-234-2345.||
2492|060|B|||
2492|061|P|PRECAUTIONS:  Before receiving palifermin, tell your doctor or||
2492|062|P|pharmacist if you are allergic to it; or if you have any other||
2492|063|P|allergies. This product may contain inactive ingredients, which||
2492|064|P|can cause allergic reactions or other problems. Talk to your||
2492|065|P|pharmacist for more details.||
2492|066|P|   Before using this medication, tell your doctor or pharmacist||
2492|067|P|your medical history.||
2492|068|P|   Before having surgery, tell your doctor or dentist about all||
2492|069|P|the products you use (including prescription drugs,||
2492|070|P|nonprescription drugs, and herbal products).||
2492|071|P|   During pregnancy, this medication should be used only when||
2492|072|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2492|073|P|benefits with your doctor.||
2492|074|P|   It is unknown if this drug passes into breast milk. Because of||
2492|075|P|the possible risk to the infant, breastfeeding is not recommended||
2492|076|P|while using this drug and for 2 weeks after the last dose.||
2492|077|P|Consult your doctor before breastfeeding.||
2492|078|B|||
2492|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2492|080|I|medications work or increase your risk for serious side effects.||
2492|081|I|This document does not contain all possible drug interactions.||
2492|082|I|Keep a list of all the products you use (including||
2492|083|I|prescription/nonprescription drugs and herbal products) and share||
2492|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
2492|085|I|the dosage of any medicines without your doctor's approval.||
2492|086|I|   A product that may interact with this drug is: melphalan.||
2492|087|B|||
2492|088|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2492|089|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2492|090|O|poison control center right away. US residents can call||
2492|091|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2492|092|B|||
2492|093|N|NOTES:  Keep all medical and lab appointments.||
2492|094|B|||
2492|095|D|MISSED DOSE:  It is important to get each dose of this medication||
2492|096|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2492|097|D|right away for a new dosing schedule.||
2492|098|B|||
2492|099|R|STORAGE:  Not applicable. This medication is given in a clinic||
2492|100|R|and will not be stored at home.||
2492|101|B|||
2492|102|A|Information last revised May 2024.||
2492|103|A|Copyright(c) 2025 First Databank, Inc.||
2492|104|B|||
2493|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2493|002|Z|does NOT have all possible information about this product. This||
2493|003|Z|information does not assure that this product is safe, effective,||
2493|004|Z|or appropriate for you. This information is not individual||
2493|005|Z|medical advice and does not substitute for the advice of your||
2493|006|Z|health care professional. Always ask your health care||
2493|007|Z|professional for complete information about this product and your||
2493|008|Z|specific health needs.||
2493|009|B|||
2493|010|T|ATORVASTATIN SUSPENSION - ORAL||
2493|011|F|(a-TOR-va-STAT-in)||
2493|012|B|||
2493|013|C|COMMON BRAND NAME(S): Atorvaliq||
2493|014|B|||
2493|015|U|USES:  Atorvastatin is used along with a proper diet to help||
2493|016|U|lower "bad" cholesterol and fats (such as LDL, triglycerides) and||
2493|017|U|raise "good" cholesterol (HDL) in the blood. It belongs to a||
2493|018|U|group of drugs known as "statins." It works by reducing the||
2493|019|U|amount of cholesterol made by the liver. Lowering "bad"||
2493|020|U|cholesterol and triglycerides and raising "good" cholesterol||
2493|021|U|decreases the risk of heart disease and helps prevent strokes and||
2493|022|U|heart attacks.||
2493|023|U|   In addition to eating a proper diet (such as a||
2493|024|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
2493|025|U|help this medication work better include exercising, losing||
2493|026|U|weight if overweight, and stopping smoking. Consult your doctor||
2493|027|U|for more details.||
2493|028|B|||
2493|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2493|030|H|from your pharmacist before you start taking atorvastatin and||
2493|031|H|each time you get a refill. If you have any questions, ask your||
2493|032|H|doctor or pharmacist.||
2493|033|H|   Take this medication by mouth as directed by your doctor,||
2493|034|H|usually once daily. It should be taken on an empty stomach, 1||
2493|035|H|hour before or 2 hours after a meal.||
2493|036|H|   The dosage is based on your medical condition, response to||
2493|037|H|treatment, age, and other medications you may be taking. Be sure||
2493|038|H|to tell your doctor and pharmacist about all the products you use||
2493|039|H|(including prescription drugs, nonprescription drugs, and herbal||
2493|040|H|products).||
2493|041|H|   Shake the bottle well before each dose. Carefully measure the||
2493|042|H|dose using a special measuring device/spoon. Do not use a||
2493|043|H|household spoon because you may not get the correct dose.||
2493|044|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2493|045|H|using this medication unless your doctor or pharmacist says you||
2493|046|H|may do so safely. Grapefruit can increase the chance of side||
2493|047|H|effects with this medicine. Ask your doctor or pharmacist for||
2493|048|H|more details.||
2493|049|H|   If you also take certain other drugs to lower your cholesterol||
2493|050|H|(bile acid-binding resins such as cholestyramine or colestipol),||
2493|051|H|take atorvastatin at least 1 hour before or at least 4 hours||
2493|052|H|after taking these medications. These products can react with||
2493|053|H|atorvastatin, preventing its full absorption.||
2493|054|H|   Take this medication regularly in order to get the most||
2493|055|H|benefit from it. Remember to take it at the same time each day.||
2493|056|H|Keep taking this medication even if you feel well. Most people||
2493|057|H|with high cholesterol or triglycerides do not feel sick.||
2493|058|H|   It is very important to continue to follow your doctor's||
2493|059|H|advice about diet and exercise. It may take up to 4 weeks before||
2493|060|H|you get the full benefit of this drug.||
2493|061|B|||
2493|062|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
2493|063|S|because your doctor has judged that the benefit to you is greater||
2493|064|S|than the risk of side effects. Many people using this medication||
2493|065|S|do not have serious side effects.||
2493|066|S|   A very small number of people taking atorvastatin may have||
2493|067|S|mild memory problems or confusion. If these rare effects occur,||
2493|068|S|talk to your doctor.||
2493|069|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
2493|070|S|doctor about the benefits and risks.||
2493|071|S|   This drug may rarely cause muscle problems (which can rarely||
2493|072|S|lead to very serious conditions called rhabdomyolysis and||
2493|073|S|autoimmune myopathy). Tell your doctor right away if you develop||
2493|074|S|any of these symptoms during treatment and if these symptoms last||
2493|075|S|after your doctor stops this drug: muscle||
2493|076|S|pain/tenderness/weakness (especially with fever or unusual||
2493|077|S|tiredness), signs of kidney problems (such as change in the||
2493|078|S|amount of urine).||
2493|079|S|   This medication may rarely cause liver problems. Tell your||
2493|080|S|doctor right away if you develop symptoms of liver problems,||
2493|081|S|including: nausea/vomiting that doesn't stop, yellowing||
2493|082|S|eyes/skin, dark urine, stomach/abdominal pain.||
2493|083|S|   A very serious allergic reaction to this drug is rare.||
2493|084|S|However, get medical help right away if you notice any symptoms||
2493|085|S|of a serious allergic reaction, including: rash, itching/swelling||
2493|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2493|087|S|breathing.||
2493|088|S|   This is not a complete list of possible side effects. If you||
2493|089|S|notice other effects not listed above, contact your doctor or||
2493|090|S|pharmacist.||
2493|091|S|   In the US -||
2493|092|S|   Call your doctor for medical advice about side effects. You||
2493|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2493|094|S|www.fda.gov/medwatch.||
2493|095|S|   In Canada - Call your doctor for medical advice about side||
2493|096|S|effects. You may report side effects to Health Canada at||
2493|097|S|1-866-234-2345.||
2493|098|B|||
2493|099|P|PRECAUTIONS:  Before taking atorvastatin, tell your doctor or||
2493|100|P|pharmacist if you are allergic to it; or if you have any other||
2493|101|P|allergies. This product may contain inactive ingredients, which||
2493|102|P|can cause allergic reactions or other problems. Talk to your||
2493|103|P|pharmacist for more details.||
2493|104|P|   Before using this medication, tell your doctor or pharmacist||
2493|105|P|your medical history, especially of: liver disease, kidney||
2493|106|P|disease, alcohol use.||
2493|107|P|   Before having surgery, tell your doctor or dentist about all||
2493|108|P|the products you use (including prescription drugs,||
2493|109|P|nonprescription drugs, and herbal products).||
2493|110|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
2493|111|P|your risk for liver problems, especially when combined with||
2493|112|P|atorvastatin. Ask your doctor or pharmacist for more information.||
2493|113|P|   Older adults may be more sensitive to the side effects of this||
2493|114|P|drug, especially muscle problems.||
2493|115|P|   During pregnancy, this medication should be used only when||
2493|116|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2493|117|P|benefits with your doctor.||
2493|118|P|   It is unknown if this medication passes into breast milk.||
2493|119|P|Because of the possible risk to the infant, breastfeeding is not||
2493|120|P|recommended while using this medication. Consult your doctor||
2493|121|P|before breastfeeding.||
2493|122|B|||
2493|123|I|DRUG INTERACTIONS:  See also How to Use section.||
2493|124|I|   Drug interactions may change how your medications work or||
2493|125|I|increase your risk for serious side effects. This document does||
2493|126|I|not contain all possible drug interactions. Keep a list of all||
2493|127|I|the products you use (including prescription/nonprescription||
2493|128|I|drugs and herbal products) and share it with your doctor and||
2493|129|I|pharmacist. Do not start, stop, or change the dosage of any||
2493|130|I|medicines without your doctor's approval.||
2493|131|I|   Some products that may interact with this drug include:||
2493|132|I|daptomycin, gemfibrozil.||
2493|133|I|   Other medications can affect the removal of atorvastatin from||
2493|134|I|your body, which may affect how atorvastatin works. Examples||
2493|135|I|include glecaprevir plus pibrentasvir, telithromycin, among||
2493|136|I|others.||
2493|137|I|   Do not take any red yeast rice products while you are taking||
2493|138|I|atorvastatin because some red yeast rice products may also||
2493|139|I|contain a statin called lovastatin. Taking atorvastatin and red||
2493|140|I|yeast rice products together can increase your risk of serious||
2493|141|I|muscle and liver problems.||
2493|142|B|||
2493|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2493|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2493|145|O|poison control center right away. US residents can call||
2493|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2493|147|B|||
2493|148|N|NOTES:  Do not share this medication with others.||
2493|149|N|   Lab and/or medical tests (such as blood||
2493|150|N|cholesterol/triglyceride levels, liver function) should be done||
2493|151|N|while you are taking this medication. Keep all medical and lab||
2493|152|N|appointments. Consult your doctor for more details.||
2493|153|B|||
2493|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2493|155|D|remember. If it is more than 12 hours after the missed dose, skip||
2493|156|D|the missed dose. Take your next dose at the regular time. Do not||
2493|157|D|double the dose to catch up.||
2493|158|B|||
2493|159|R|STORAGE:  Store in the original container at room temperature||
2493|160|R|away from light. Once the bottle is opened, this medication||
2493|161|R|expires after 60 days. Keep all medications away from children||
2493|162|R|and pets.||
2493|163|R|   Do not flush medications down the toilet or pour them into a||
2493|164|R|drain unless instructed to do so. Properly discard this product||
2493|165|R|when it is expired or no longer needed. Consult your pharmacist||
2493|166|R|or local waste disposal company.||
2493|167|B|||
2493|168|A|Information last revised July 2024.||
2493|169|A|Copyright(c) 2025 First Databank, Inc.||
2493|170|B|||
2494|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2494|002|Z|does NOT have all possible information about this product. This||
2494|003|Z|information does not assure that this product is safe, effective,||
2494|004|Z|or appropriate for you. This information is not individual||
2494|005|Z|medical advice and does not substitute for the advice of your||
2494|006|Z|health care professional. Always ask your health care||
2494|007|Z|professional for complete information about this product and your||
2494|008|Z|specific health needs.||
2494|009|B|||
2494|010|T|DEUTETRABENAZINE EXTENDED-RELEASE - ORAL||
2494|011|F|(DOO-tet-ra-BEN-a-zeen)||
2494|012|B|||
2494|013|C|COMMON BRAND NAME(S): Austedo XR||
2494|014|B|||
2494|015|W|WARNING:  If you have Huntington's disease, deutetrabenazine can||
2494|016|W|sometimes increase the risk of depression and suicidal||
2494|017|W|thoughts/attempts. People with Huntington's disease are already||
2494|018|W|more likely to have depression and suicidal thoughts/attempts.||
2494|019|W|Talk with your doctor about the risks and benefits of this||
2494|020|W|medication. People with Huntington's disease and depression must||
2494|021|W|not use deutetrabenazine if they are not being treated for||
2494|022|W|depression or if they still have symptoms of depression with||
2494|023|W|medication/treatment. Tell your doctor right away if you or your||
2494|024|W|family/caregivers notice that you have new/worsening symptoms of||
2494|025|W|depression, sadness, loss of interest in activities you used to||
2494|026|W|enjoy, suicidal thoughts/attempts, or other mental/mood/behavior||
2494|027|W|changes (such as new/worsening anxiety, panic attacks, trouble||
2494|028|W|sleeping, irritability, hostile/angry feelings).||
2494|029|B|||
2494|030|U|USES:  Deutetrabenazine is used to decrease involuntary movements||
2494|031|U|(chorea) caused by Huntington's disease. It is also used to treat||
2494|032|U|involuntary movements of the face, tongue, or other body parts||
2494|033|U|(tardive dyskinesia). Reducing involuntary movements will help||
2494|034|U|you take part in more of your normal daily activities. This||
2494|035|U|medication is thought to work by decreasing the amount of certain||
2494|036|U|natural substances in the brain that affect how your nerves and||
2494|037|U|muscles work (monoamines such as dopamine, serotonin, and||
2494|038|U|norepinephrine).||
2494|039|B|||
2494|040|H|HOW TO USE:  Read the Medication Guide provided by your||
2494|041|H|pharmacist before you start using deutetrabenazine and each time||
2494|042|H|you get a refill. If you have any questions, ask your doctor or||
2494|043|H|pharmacist.||
2494|044|H|   Take this medication by mouth with or without food as directed||
2494|045|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2494|046|H|not crush, chew, or break the tablets. Doing so can release all||
2494|047|H|of the drug at once, increasing the risk of side effects.||
2494|048|H|   The dosage is based on your medical condition, response to||
2494|049|H|treatment, and other medications you may be taking. Be sure to||
2494|050|H|tell your doctor and pharmacist about all the products you use||
2494|051|H|(including prescription drugs, nonprescription drugs, and herbal||
2494|052|H|products).||
2494|053|H|   To reduce your risk of side effects, your doctor may direct||
2494|054|H|you to start this medication at a low dose and gradually increase||
2494|055|H|your dose. Follow your doctor's instructions carefully.||
2494|056|H|   Use this medication regularly to get the most benefit from it.||
2494|057|H|To help you remember, take it at the same time each day. If you||
2494|058|H|stop taking this medication for more than 1 week, do not take||
2494|059|H|another dose until you talk to your doctor. You may need to||
2494|060|H|restart your medication at a lower dose.||
2494|061|H|   Tell your doctor if you do not get better or if you get worse.||
2494|062|B|||
2494|063|S|SIDE EFFECTS:  See also Warning section.||
2494|064|S|   Drowsiness, trouble sleeping, tiredness, dizziness, nausea, or||
2494|065|S|vomiting may occur. If any of these effects last or get worse,||
2494|066|S|tell your doctor or pharmacist promptly. Your doctor may need to||
2494|067|S|adjust your dose to reduce these side effects.||
2494|068|S|   To reduce the risk of dizziness and lightheadedness, get up||
2494|069|S|slowly when rising from a sitting or lying position.||
2494|070|S|   You may notice an empty tablet shell in your stool. This is||
2494|071|S|harmless because your body has already absorbed the medicine.||
2494|072|S|   Remember that this medication has been prescribed because your||
2494|073|S|doctor has judged that the benefit to you is greater than the||
2494|074|S|risk of side effects. Many people using this medication do not||
2494|075|S|have serious side effects.||
2494|076|S|   Tell your doctor right away if you have any serious side||
2494|077|S|effects, including: agitation/restlessness, Parkinson's disease||
2494|078|S|symptoms (such as shaking/tremors, slowed movement, loss of||
2494|079|S|balance).||
2494|080|S|   Sometimes deutetrabenazine can cause side effects that are||
2494|081|S|similar to the symptoms of worsening Huntington's disease. Your||
2494|082|S|doctor may need to adjust your dose to see if these side effects||
2494|083|S|are due to the drug or to the disease. Tell your doctor right||
2494|084|S|away if any of these serious side effects occur: mental/mood||
2494|085|S|changes (such as new/worsening depression, suicidal||
2494|086|S|thoughts/attempts, problems with thinking), trouble swallowing,||
2494|087|S|uncontrolled muscle movements of the face (such as lip smacking,||
2494|088|S|unusual tongue movements), signs of increased prolactin hormone||
2494|089|S|(such as enlarged breasts, abnormal breast milk production,||
2494|090|S|decreased sexual ability, a change in menstrual cycle).||
2494|091|S|   This medication may rarely cause a very serious condition||
2494|092|S|called neuroleptic malignant syndrome (NMS). Get medical help||
2494|093|S|right away if you have any of the following symptoms: fever,||
2494|094|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
2494|095|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
2494|096|S|signs of kidney problems (such as change in the amount of urine).||
2494|097|S|   A very serious allergic reaction to this drug is rare.||
2494|098|S|However, get medical help right away if you notice any symptoms||
2494|099|S|of a serious allergic reaction, including: rash, itching/swelling||
2494|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2494|101|S|breathing.||
2494|102|S|   This is not a complete list of possible side effects. If you||
2494|103|S|notice other effects not listed above, contact your doctor or||
2494|104|S|pharmacist.||
2494|105|S|   In the US -||
2494|106|S|   Call your doctor for medical advice about side effects. You||
2494|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2494|108|S|www.fda.gov/medwatch.||
2494|109|S|   In Canada - Call your doctor for medical advice about side||
2494|110|S|effects. You may report side effects to Health Canada at||
2494|111|S|1-866-234-2345.||
2494|112|B|||
2494|113|P|PRECAUTIONS:  See also Warning section.||
2494|114|P|   Before taking deutetrabenazine, tell your doctor or pharmacist||
2494|115|P|if you are allergic to it; or to tetrabenazine; or if you have||
2494|116|P|any other allergies. This product may contain inactive||
2494|117|P|ingredients, which can cause allergic reactions or other||
2494|118|P|problems. Talk to your pharmacist for more details.||
2494|119|P|   Before using this medication, tell your doctor or pharmacist||
2494|120|P|your medical history, especially of: breast cancer, liver||
2494|121|P|problems, certain heart problems (fast/slow/irregular heartbeat,||
2494|122|P|QT prolongation in the EKG).||
2494|123|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2494|124|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2494|125|P|machinery, or do anything that needs alertness until you can do||
2494|126|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2494|127|P|are using marijuana (cannabis).||
2494|128|P|   Before having surgery, tell your doctor or dentist about all||
2494|129|P|the products you use (including prescription drugs,||
2494|130|P|nonprescription drugs, and herbal products).||
2494|131|P|   During pregnancy, this medication should be used only when||
2494|132|P|clearly needed. Discuss the risks and benefits with your doctor.||
2494|133|P|   It is unknown if this drug passes into breast milk. Consult||
2494|134|P|your doctor before breastfeeding.||
2494|135|B|||
2494|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2494|137|I|medications work or increase your risk for serious side effects.||
2494|138|I|This document does not contain all possible drug interactions.||
2494|139|I|Keep a list of all the products you use (including||
2494|140|I|prescription/nonprescription drugs and herbal products) and share||
2494|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
2494|142|I|the dosage of any medicines without your doctor's approval.||
2494|143|I|   A product that may interact with this drug is: valbenazine.||
2494|144|I|   Taking MAO inhibitors with this medication may cause a serious||
2494|145|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
2494|146|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2494|147|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2494|148|I|selegiline, tranylcypromine) during treatment with this||
2494|149|I|medication. Most MAO inhibitors should also not be taken for two||
2494|150|I|weeks before and after treatment with this medication. Ask your||
2494|151|I|doctor when to start or stop taking this medication.||
2494|152|I|   Deutetrabenazine is very similar to tetrabenazine. Do not use||
2494|153|I|medications containing tetrabenazine while using||
2494|154|I|deutetrabenazine.||
2494|155|B|||
2494|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2494|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2494|158|O|poison control center right away. US residents can call||
2494|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2494|160|O|Symptoms of overdose may include: muscle stiffness/pain, fixed||
2494|161|O|upward position of the eyeballs, sweating, dizziness, severe||
2494|162|O|drowsiness.||
2494|163|B|||
2494|164|N|NOTES:  Do not share this medication with others.||
2494|165|B|||
2494|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2494|167|D|remember. If it is near the time of the next dose, skip the||
2494|168|D|missed dose. Take your next dose at the regular time. Do not||
2494|169|D|double the dose to catch up.||
2494|170|B|||
2494|171|R|STORAGE:  Store at room temperature away from light and moisture.||
2494|172|R|Do not store in the bathroom. Keep the drying agent (desiccant)||
2494|173|R|in the bottle. Tightly close the bottle when not in use. Keep all||
2494|174|R|medications away from children and pets.||
2494|175|R|   Do not flush medications down the toilet or pour them into a||
2494|176|R|drain unless instructed to do so. Properly discard this product||
2494|177|R|when it is expired or no longer needed. Consult your pharmacist||
2494|178|R|or local waste disposal company.||
2494|179|B|||
2494|180|A|Information last revised September 2024.||
2494|181|A|Copyright(c) 2025 First Databank, Inc.||
2494|182|B|||
2495|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2495|002|Z|does NOT have all possible information about this product. This||
2495|003|Z|information does not assure that this product is safe, effective,||
2495|004|Z|or appropriate for you. This information is not individual||
2495|005|Z|medical advice and does not substitute for the advice of your||
2495|006|Z|health care professional. Always ask your health care||
2495|007|Z|professional for complete information about this product and your||
2495|008|Z|specific health needs.||
2495|009|B|||
2495|010|T|ELEXACAFTOR/TEZACAFTOR/IVACAFTOR AND IVACAFTOR GRANULES - ORAL||
2495|011|F|(el-EX-a-KAF-tor/TEZ-a-KAF-tor/EYE-va-KAF-tor and EYE-va-KAF-tor)||
2495|012|B|||
2495|013|C|COMMON BRAND NAME(S): Trikafta||
2495|014|B|||
2495|015|W|WARNING:  This medication may rarely cause serious (possibly||
2495|016|W|fatal) liver problems. Before and during treatment with this||
2495|017|W|medication, you will have certain blood tests (liver function) to||
2495|018|W|monitor for liver problems. Keep all medical and lab||
2495|019|W|appointments. Get medical help right away if you have any||
2495|020|W|symptoms of liver damage, such as: nausea/vomiting that doesn't||
2495|021|W|stop, stomach/abdominal pain, dark urine, loss of appetite,||
2495|022|W|yellowing eyes/skin.||
2495|023|B|||
2495|024|U|USES:  This product has 2 different types of granule packets. One||
2495|025|U|type of granule packet contains 3 medications (it is a||
2495|026|U|"multi-drug"): elexacaftor, tezacaftor, and ivacaftor. The other||
2495|027|U|type of granule packet contains only ivacaftor.||
2495|028|U|   This product is used to treat cystic fibrosis in certain||
2495|029|U|people (those with an abnormal "CFTR" gene). It may help to||
2495|030|U|improve breathing, reduce the risk of lung infections, and||
2495|031|U|improve weight gain.||
2495|032|B|||
2495|033|H|HOW TO USE:  Read the Medication Guide provided by your||
2495|034|H|pharmacist before you start using this medication and each time||
2495|035|H|you get a refill. If you have any questions, ask your doctor or||
2495|036|H|pharmacist.||
2495|037|H|   Take these medications by mouth as directed by your doctor,||
2495|038|H|usually 1 multi-drug granule packet in the morning, and 1||
2495|039|H|ivacaftor granule packet about 12 hours later in the evening. Eat||
2495|040|H|fat-containing food either right before or just after taking the||
2495|041|H|mixture. Some examples are eggs, meat, nuts, butter, peanut||
2495|042|H|butter, whole-milk dairy products (such as whole milk, cheese,||
2495|043|H|yogurt).||
2495|044|H|   Mix each type of granule packet as directed before taking.||
2495|045|H|Gently shake the packet before use. Open the packet and pour its||
2495|046|H|contents into a small cup with 1 teaspoonful (5 milliliters) of||
2495|047|H|soft food (such as pureed fruits or vegetables, yogurt,||
2495|048|H|applesauce) or liquid (such as water, milk, juice). The soft food||
2495|049|H|or liquid should be at or below room temperature. Mix the||
2495|050|H|granules with the soft food or liquid and take the entire mixture||
2495|051|H|within 1 hour of mixing.||
2495|052|H|   The dosage is based on your medical condition, age, weight,||
2495|053|H|response to treatment, and other medications you may be taking.||
2495|054|H|Be sure to tell your doctor and pharmacist about all the products||
2495|055|H|you use (including prescription drugs, nonprescription drugs, and||
2495|056|H|herbal products).||
2495|057|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2495|058|H|using this medication unless your doctor or pharmacist says you||
2495|059|H|may do so safely. Grapefruit can increase the chance of side||
2495|060|H|effects with this medicine. Ask your doctor or pharmacist for||
2495|061|H|more details.||
2495|062|H|   Use this product regularly to get the most benefit from it. To||
2495|063|H|help you remember, take it at the same times each day.||
2495|064|H|   Tell your doctor if you do not get better or if you get worse.||
2495|065|B|||
2495|066|S|SIDE EFFECTS:  See also Warning section.||
2495|067|S|   Headache, diarrhea, or dizziness may occur. If any of these||
2495|068|S|effects last or get worse, tell your doctor or pharmacist||
2495|069|S|promptly.||
2495|070|S|   Remember that this product has been prescribed because your||
2495|071|S|doctor has judged that the benefit to you is greater than the||
2495|072|S|risk of side effects. Many people using this product do not have||
2495|073|S|serious side effects.||
2495|074|S|   This medication may rarely cause increased pressure around the||
2495|075|S|brain (intracranial hypertension-IH). Get medical help right away||
2495|076|S|if any of these very serious side effects occur: headache that is||
2495|077|S|severe or doesn't go away, vision changes (such as blurred/double||
2495|078|S|vision, decreased vision).||
2495|079|S|   This product can commonly cause a rash (especially in females)||
2495|080|S|that is usually not serious. However, you may not be able to tell||
2495|081|S|it apart from a rare rash that could be a sign of a severe||
2495|082|S|reaction. Get medical help right away if you develop any rash.||
2495|083|S|   A very serious allergic reaction to this drug is rare.||
2495|084|S|However, get medical help right away if you notice any symptoms||
2495|085|S|of a serious allergic reaction, including: rash, itching/swelling||
2495|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2495|087|S|breathing.||
2495|088|S|   This is not a complete list of possible side effects. If you||
2495|089|S|notice other effects not listed above, contact your doctor or||
2495|090|S|pharmacist.||
2495|091|S|   In the US -||
2495|092|S|   Call your doctor for medical advice about side effects. You||
2495|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2495|094|S|www.fda.gov/medwatch.||
2495|095|S|   In Canada - Call your doctor for medical advice about side||
2495|096|S|effects. You may report side effects to Health Canada at||
2495|097|S|1-866-234-2345.||
2495|098|B|||
2495|099|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2495|100|P|pharmacist if you are allergic to elexacaftor, tezacaftor, or||
2495|101|P|ivacaftor; or if you have any other allergies. This product may||
2495|102|P|contain inactive ingredients, which can cause allergic reactions||
2495|103|P|or other problems. Talk to your pharmacist for more details.||
2495|104|P|   Before using this product, tell your doctor or pharmacist your||
2495|105|P|medical history, especially of: liver disease, kidney disease.||
2495|106|P|   This product may make you dizzy. Alcohol or marijuana||
2495|107|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
2495|108|P|or do anything that needs alertness until you can do it safely.||
2495|109|P|Limit alcoholic beverages. Talk to your doctor if you are using||
2495|110|P|marijuana (cannabis).||
2495|111|P|   Before having surgery, tell your doctor or dentist about all||
2495|112|P|the products you use (including prescription drugs,||
2495|113|P|nonprescription drugs, and herbal products).||
2495|114|P|   During pregnancy, this product should be used only when||
2495|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
2495|116|P|   This product passes into breast milk. Consult your doctor||
2495|117|P|before breastfeeding.||
2495|118|B|||
2495|119|I|DRUG INTERACTIONS:  See also How to Use section.||
2495|120|I|   Drug interactions may change how your medications work or||
2495|121|I|increase your risk for serious side effects. This document does||
2495|122|I|not contain all possible drug interactions. Keep a list of all||
2495|123|I|the products you use (including prescription/nonprescription||
2495|124|I|drugs and herbal products) and share it with your doctor and||
2495|125|I|pharmacist. Do not start, stop, or change the dosage of any||
2495|126|I|medicines without your doctor's approval.||
2495|127|I|   Other medications can affect the removal of elexacaftor,||
2495|128|I|tezacaftor, and ivacaftor from your body, which may affect how||
2495|129|I|this product works. Examples include mifepristone, rifamycins||
2495|130|I|(such as rifampin, rifabutin), drugs for seizures (such as||
2495|131|I|carbamazepine, phenytoin), St. John's wort, among others.||
2495|132|B|||
2495|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2495|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2495|135|O|poison control center right away. US residents can call||
2495|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2495|137|B|||
2495|138|N|NOTES:  Do not share this product with others.||
2495|139|N|   Lab and/or medical tests (such as CFTR gene testing,||
2495|140|N|liver/lung function, eye exams) should be done before you start||
2495|141|N|taking this product and while you are taking it. Keep all medical||
2495|142|N|and lab appointments.||
2495|143|B|||
2495|144|D|MISSED DOSE:  If you miss a morning or evening dose and it has||
2495|145|D|been less than 6 hours, take it as soon as you remember. Do not||
2495|146|D|take a morning and evening dose at the same time. Do not double||
2495|147|D|the dose to catch up.||
2495|148|D|   If you miss the morning dose and it has been more than 6||
2495|149|D|hours, take it as soon as you remember and do not take the||
2495|150|D|evening dose. Take your next day's doses at the regular times.||
2495|151|D|   If you miss the evening dose and it has been more than 6||
2495|152|D|hours, skip the missed evening dose. Take your next day's doses||
2495|153|D|at the regular times.||
2495|154|B|||
2495|155|R|STORAGE:  Store at room temperature away from light and moisture.||
2495|156|R|Do not store in the bathroom. Keep all medications away from||
2495|157|R|children and pets.||
2495|158|R|   Do not flush medications down the toilet or pour them into a||
2495|159|R|drain unless instructed to do so. Properly discard this product||
2495|160|R|when it is expired or no longer needed. Consult your pharmacist||
2495|161|R|or local waste disposal company.||
2495|162|B|||
2495|163|A|Information last revised September 2025.||
2495|164|A|Copyright(c) 2025 First Databank, Inc.||
2495|165|B|||
2496|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2496|002|Z|does NOT have all possible information about this product. This||
2496|003|Z|information does not assure that this product is safe, effective,||
2496|004|Z|or appropriate for you. This information is not individual||
2496|005|Z|medical advice and does not substitute for the advice of your||
2496|006|Z|health care professional. Always ask your health care||
2496|007|Z|professional for complete information about this product and your||
2496|008|Z|specific health needs.||
2496|009|B|||
2496|010|T|LEUPROLIDE 6 MONTH PEDIATRIC - INTRAMUSCULAR INJECTION||
2496|011|F|(LOO-proe-lide)||
2496|012|B|||
2496|013|C|COMMON BRAND NAME(S): Lupron Depot-Ped||
2496|014|B|||
2496|015|U|USES:  Leuprolide is used to stop early puberty (precocious||
2496|016|U|puberty) in children. It helps to delay sexual development (such||
2496|017|U|as growth of the breasts/testicles) and the start of menstrual||
2496|018|U|periods. It also helps slow down early bone growth to increase||
2496|019|U|the likelihood of reaching normal adult height. Leuprolide works||
2496|020|U|by decreasing the amount of sex hormones that a child's body||
2496|021|U|makes (estrogen in girls, testosterone in boys).||
2496|022|B|||
2496|023|V|OTHER USES:  This section contains uses of this drug that are not||
2496|024|V|listed in the approved professional labeling for the drug but||
2496|025|V|that may be prescribed by your health care professional. Use this||
2496|026|V|drug for a condition that is listed in this section only if it||
2496|027|V|has been so prescribed by your health care professional.||
2496|028|V|   This drug may also be used for gender dysphoria.||
2496|029|B|||
2496|030|H|HOW TO USE:  Read the Medication Guide provided by the pharmacist||
2496|031|H|before your child starts using leuprolide and each time you get a||
2496|032|H|refill. If you have any questions, ask the doctor or pharmacist.||
2496|033|H|   This medication is given by injection into a muscle by a||
2496|034|H|health care professional. It is given as directed by the doctor,||
2496|035|H|usually once every 6 months (every 24 weeks). This product slowly||
2496|036|H|releases the medication into the blood over a 6-month period.||
2496|037|H|   Children's dosage is based on weight and response to||
2496|038|H|treatment. The doctor should consider stopping treatment before||
2496|039|H|age 11 for girls and age 12 for boys. Consult the doctor for||
2496|040|H|details.||
2496|041|H|   Use this medication regularly to get the most benefit from it.||
2496|042|H|To help you remember, mark your calendar with a reminder.||
2496|043|H|   During the first few weeks of treatment, hormone levels will||
2496|044|H|actually go up before they go down. This is a normal response to||
2496|045|H|this medication. You may notice worsening symptoms of early||
2496|046|H|puberty (such as menstrual periods) at the start of treatment.||
2496|047|H|However, you should see an improvement in symptoms usually within||
2496|048|H|1 to 2 months. Tell the doctor promptly if new or worsened||
2496|049|H|symptoms develop after starting treatment.||
2496|050|B|||
2496|051|S|SIDE EFFECTS:  Headache, fever, stomach pain, diarrhea, increased||
2496|052|S|sweating, weight gain, trouble sleeping, breast tenderness, or||
2496|053|S|mild pain/bruising/swelling at the injection site may occur. If||
2496|054|S|any of these effects last or get worse, tell the doctor or||
2496|055|S|pharmacist promptly.||
2496|056|S|   When this medication is used regularly, it is expected that||
2496|057|S|the menstrual period will stop or decrease to light||
2496|058|S|bleeding/spotting during the first 2 months. Tell the doctor||
2496|059|S|promptly if regular periods continue after 2 months of treatment||
2496|060|S|with leuprolide.||
2496|061|S|   Remember that this medication has been prescribed because the||
2496|062|S|doctor has judged that the benefit is greater than the risk of||
2496|063|S|side effects. Many people using this medication do not have||
2496|064|S|serious side effects.||
2496|065|S|   Tell the doctor right away if your child has any serious side||
2496|066|S|effects, including: mental/mood changes (such as non-stop crying,||
2496|067|S|irritability, mood swings, aggression).||
2496|068|S|   Get medical help right away if your child has any very serious||
2496|069|S|side effects, including: seizures.||
2496|070|S|   Children using leuprolide may be at risk for increased||
2496|071|S|pressure around the brain (intracranial hypertension). Get||
2496|072|S|medical help right away if your child has any of these very||
2496|073|S|serious side effects: nausea/vomiting that doesn't stop, headache||
2496|074|S|that is severe or doesn't go away, eye pain, vision changes (such||
2496|075|S|as blurred/double vision, decreased vision), ringing in the ears.||
2496|076|S|   A very serious allergic reaction to this drug is rare.||
2496|077|S|However, get medical help right away if you notice any symptoms||
2496|078|S|of a serious allergic reaction, including: fever, swollen lymph||
2496|079|S|nodes, rash, itching/swelling (especially of the||
2496|080|S|face/tongue/throat), severe dizziness, trouble breathing.||
2496|081|S|   This is not a complete list of possible side effects. If you||
2496|082|S|notice other effects not listed above, contact your doctor or||
2496|083|S|pharmacist.||
2496|084|S|   In the US -||
2496|085|S|   Call your doctor for medical advice about side effects. You||
2496|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2496|087|S|www.fda.gov/medwatch.||
2496|088|S|   In Canada - Call your doctor for medical advice about side||
2496|089|S|effects. You may report side effects to Health Canada at||
2496|090|S|1-866-234-2345.||
2496|091|B|||
2496|092|P|PRECAUTIONS:  Before using leuprolide, tell the doctor or||
2496|093|P|pharmacist if your child is allergic to it; or to similar drugs||
2496|094|P|(such as histrelin, triptorelin); or if your child has any other||
2496|095|P|allergies. This product may contain inactive ingredients, which||
2496|096|P|can cause allergic reactions or other problems. Talk to the||
2496|097|P|pharmacist for more details.||
2496|098|P|   Before using this medication, tell the doctor or pharmacist||
2496|099|P|your child's medical history, especially of: mental/mood problems||
2496|100|P|(such as depression), seizures.||
2496|101|P|   Before having surgery, tell the doctor or dentist about all||
2496|102|P|the products being used (including prescription drugs,||
2496|103|P|nonprescription drugs, and herbal products).||
2496|104|P|   This medication must not be used during pregnancy. It may harm||
2496|105|P|an unborn baby. Discuss the use of reliable forms of non-hormonal||
2496|106|P|birth control (such as condoms, diaphragm with spermicide) with||
2496|107|P|your doctor. If you become pregnant or think you may be pregnant,||
2496|108|P|tell your doctor right away.||
2496|109|P|   It is unknown if leuprolide passes into breast milk. Because||
2496|110|P|of the possible risk to the infant, breastfeeding is not||
2496|111|P|recommended while using this medication. Consult your doctor||
2496|112|P|before breastfeeding.||
2496|113|B|||
2496|114|I|DRUG INTERACTIONS:  Drug interactions may change how medications||
2496|115|I|work or increase the risk for serious side effects. This document||
2496|116|I|does not contain all possible drug interactions. Keep a list of||
2496|117|I|all the products used (including prescription/nonprescription||
2496|118|I|drugs and herbal products) and share it with the doctor and||
2496|119|I|pharmacist. Do not start, stop, or change the dosage of any||
2496|120|I|medicines without the doctor's approval.||
2496|121|I|   This medication may interfere with certain lab tests, possibly||
2496|122|I|causing false test results. Make sure lab personnel and all the||
2496|123|I|doctors know your child uses this drug.||
2496|124|B|||
2496|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2496|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2496|127|O|poison control center right away. US residents can call||
2496|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2496|129|B|||
2496|130|N|NOTES:  Do not share this medication with others.||
2496|131|N|   Lab and/or medical tests (such as hormone levels, height||
2496|132|N|measurements, bone tests) should be done while using this||
2496|133|N|medication. Keep all medical and lab appointments. Consult the||
2496|134|N|doctor for more details.||
2496|135|B|||
2496|136|D|MISSED DOSE:  It is important to get each dose of this medication||
2496|137|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
2496|138|D|right away for a new dosing schedule. Do not double the dose to||
2496|139|D|catch up.||
2496|140|B|||
2496|141|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2496|142|R|doctor's office and will not be stored at home.||
2496|143|B|||
2496|144|A|Information last revised October 2024.||
2496|145|A|Copyright(c) 2025 First Databank, Inc.||
2496|146|B|||
2497|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2497|002|Z|does NOT have all possible information about this product. This||
2497|003|Z|information does not assure that this product is safe, effective,||
2497|004|Z|or appropriate for you. This information is not individual||
2497|005|Z|medical advice and does not substitute for the advice of your||
2497|006|Z|health care professional. Always ask your health care||
2497|007|Z|professional for complete information about this product and your||
2497|008|Z|specific health needs.||
2497|009|B|||
2497|010|T|TOFERSEN - INJECTION||
2497|011|F|(toe-FER-sen)||
2497|012|B|||
2497|013|C|COMMON BRAND NAME(S): Qalsody||
2497|014|B|||
2497|015|U|USES:  Tofersen is used to treat a certain type of nerve disease||
2497|016|U|called amyotrophic lateral sclerosis (ALS, also commonly called||
2497|017|U|Lou Gehrig's disease).||
2497|018|B|||
2497|019|H|HOW TO USE:  This medication is given by injection into the area||
2497|020|H|around the spinal cord (intrathecal) by a health care||
2497|021|H|professional. It is given as directed by your doctor, usually||
2497|022|H|once every 2 weeks for the first 3 doses and then once every 4||
2497|023|H|weeks.||
2497|024|H|   Use this medication regularly to get the most benefit from it.||
2497|025|H|To help you remember, mark your calendar with a reminder.||
2497|026|H|   Tell your doctor if your condition gets worse.||
2497|027|B|||
2497|028|S|SIDE EFFECTS:  Joint pain, muscle pain, or tiredness may occur.||
2497|029|S|If any of these effects last or get worse, tell your doctor or||
2497|030|S|pharmacist promptly.||
2497|031|S|   Remember that this medication has been prescribed because your||
2497|032|S|doctor has judged that the benefit to you is greater than the||
2497|033|S|risk of side effects. Many people using this medication do not||
2497|034|S|have serious side effects.||
2497|035|S|   Tell your doctor right away if you have any serious side||
2497|036|S|effects, including: numbness/tingling/burning of arms/legs.||
2497|037|S|   Get medical help right away if you have any very serious side||
2497|038|S|effects, including: signs of swelling of the lining around the||
2497|039|S|brain (such as headache that is severe or doesn't go away, fever,||
2497|040|S|stiff/painful neck, confusion, seizures), vision changes (such as||
2497|041|S|blurred/double vision, decreased vision, sudden blindness).||
2497|042|S|   A very serious allergic reaction to this drug is rare.||
2497|043|S|However, get medical help right away if you notice any symptoms||
2497|044|S|of a serious allergic reaction, including: rash, itching/swelling||
2497|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2497|046|S|breathing.||
2497|047|S|   This is not a complete list of possible side effects. If you||
2497|048|S|notice other effects not listed above, contact your doctor or||
2497|049|S|pharmacist.||
2497|050|S|   In the US -||
2497|051|S|   Call your doctor for medical advice about side effects. You||
2497|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2497|053|S|www.fda.gov/medwatch.||
2497|054|S|   In Canada - Call your doctor for medical advice about side||
2497|055|S|effects. You may report side effects to Health Canada at||
2497|056|S|1-866-234-2345.||
2497|057|B|||
2497|058|P|PRECAUTIONS:  Before using tofersen, tell your doctor or||
2497|059|P|pharmacist if you are allergic to it; or if you have any other||
2497|060|P|allergies. This product may contain inactive ingredients, which||
2497|061|P|can cause allergic reactions or other problems. Talk to your||
2497|062|P|pharmacist for more details.||
2497|063|P|   Before using this medication, tell your doctor or pharmacist||
2497|064|P|your medical history.||
2497|065|P|   Before having surgery, tell your doctor or dentist about all||
2497|066|P|the products you use (including prescription drugs,||
2497|067|P|nonprescription drugs, and herbal products).||
2497|068|P|   During pregnancy, this medication should be used only when||
2497|069|P|clearly needed. Discuss the risks and benefits with your doctor.||
2497|070|P|   It is unknown if this medication passes into breast milk.||
2497|071|P|Consult your doctor before breastfeeding.||
2497|072|B|||
2497|073|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2497|074|I|medications work or increase your risk for serious side effects.||
2497|075|I|This document does not contain all possible drug interactions.||
2497|076|I|Keep a list of all the products you use (including||
2497|077|I|prescription/nonprescription drugs and herbal products) and share||
2497|078|I|it with your doctor and pharmacist. Do not start, stop, or change||
2497|079|I|the dosage of any medicines without your doctor's approval.||
2497|080|B|||
2497|081|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2497|082|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2497|083|O|poison control center right away. US residents can call||
2497|084|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2497|085|B|||
2497|086|N|NOTES:  Keep all medical and lab appointments.||
2497|087|B|||
2497|088|D|MISSED DOSE:  It is important to get each dose of this medication||
2497|089|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2497|090|D|right away for a new dosing schedule.||
2497|091|B|||
2497|092|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2497|093|R|doctor's office and will not be stored at home.||
2497|094|B|||
2497|095|A|Information last revised October 2024.||
2497|096|A|Copyright(c) 2025 First Databank, Inc.||
2497|097|B|||
2498|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2498|002|Z|does NOT have all possible information about this product. This||
2498|003|Z|information does not assure that this product is safe, effective,||
2498|004|Z|or appropriate for you. This information is not individual||
2498|005|Z|medical advice and does not substitute for the advice of your||
2498|006|Z|health care professional. Always ask your health care||
2498|007|Z|professional for complete information about this product and your||
2498|008|Z|specific health needs.||
2498|009|B|||
2498|010|T|TOPIRAMATE SOLUTION - ORAL||
2498|011|F|(toe-PEER-uh-mate)||
2498|012|B|||
2498|013|C|COMMON BRAND NAME(S): Eprontia||
2498|014|B|||
2498|015|U|USES:  Topiramate is used alone or with other medications to||
2498|016|U|prevent and control seizures (epilepsy). This medication is also||
2498|017|U|used to prevent migraine headaches and decrease how often you get||
2498|018|U|them. Topiramate will not treat a migraine headache once it||
2498|019|U|occurs. If you get a migraine headache, treat it as directed by||
2498|020|U|your doctor (such as by taking pain medication, lying down in a||
2498|021|U|dark room).||
2498|022|U|   Topiramate is known as an anticonvulsant or antiepileptic||
2498|023|U|drug.||
2498|024|B|||
2498|025|V|OTHER USES:  This section contains uses of this drug that are not||
2498|026|V|listed in the approved professional labeling for the drug but||
2498|027|V|that may be prescribed by your health care professional. Use this||
2498|028|V|drug for a condition that is listed in this section only if it||
2498|029|V|has been so prescribed by your health care professional.||
2498|030|V|   This drug may also be used for binge eating disorder (BED).||
2498|031|B|||
2498|032|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2498|033|H|Patient Information Leaflet provided by your pharmacist before||
2498|034|H|you start taking topiramate and each time you get a refill. If||
2498|035|H|you have any questions, ask your doctor or pharmacist.||
2498|036|H|   Take this medication by mouth with or without food as directed||
2498|037|H|by your doctor, usually twice daily. Carefully measure the dose||
2498|038|H|using a special measuring device/spoon. Do not use a household||
2498|039|H|spoon because you may not get the correct dose. To prevent kidney||
2498|040|H|stones from forming, drink plenty of liquids while taking this||
2498|041|H|medication unless your doctor instructs you otherwise.||
2498|042|H|   The dosage is based on your medical condition and response to||
2498|043|H|treatment. Children's dosage is also based on weight. Your doctor||
2498|044|H|will gradually increase your dose to reduce your risk of side||
2498|045|H|effects. For some conditions, you may start treatment with||
2498|046|H|topiramate once daily at bedtime and slowly increase your dose to||
2498|047|H|twice a day. It may take several weeks or months to reach the||
2498|048|H|best dose for you and to get the full benefit from this||
2498|049|H|medication.||
2498|050|H|   Take this medication regularly to get the most benefit from||
2498|051|H|it. To help you remember, take it at the same times each day. Do||
2498|052|H|not stop taking this medication without consulting your doctor.||
2498|053|H|Some conditions may become worse when this drug is suddenly||
2498|054|H|stopped. Your dose may need to be gradually decreased.||
2498|055|H|   Tell your doctor if your condition lasts or if it gets worse.||
2498|056|B|||
2498|057|S|SIDE EFFECTS:  Tiredness, drowsiness, dizziness, loss of||
2498|058|S|coordination, nervousness, tingling of the hands/feet, loss of||
2498|059|S|appetite, changes in how foods taste, diarrhea, or weight loss||
2498|060|S|may occur. If any of these effects last or get worse, tell your||
2498|061|S|doctor or pharmacist promptly.||
2498|062|S|   Remember that this medication has been prescribed because your||
2498|063|S|doctor has judged that the benefit to you is greater than the||
2498|064|S|risk of side effects. Many people using this medication do not||
2498|065|S|have serious side effects.||
2498|066|S|   Tell your doctor right away if you have any serious side||
2498|067|S|effects, including: bone pain, signs of kidney stones (such as||
2498|068|S|severe back/side/abdominal/groin pain, fever, chills,||
2498|069|S|painful/frequent urination, bloody/pink urine), unusual||
2498|070|S|bleeding/bruising, confusion, difficulty concentrating, memory||
2498|071|S|loss, difficulty speaking.||
2498|072|S|   Get medical help right away if you have any very serious side||
2498|073|S|effects, including: rapid breathing, fast/slow/irregular||
2498|074|S|heartbeat.||
2498|075|S|   A small number of people who take anticonvulsants for any||
2498|076|S|condition (such as seizures, bipolar disorder, pain) may||
2498|077|S|experience depression, suicidal thoughts/attempts, or other||
2498|078|S|mental/mood problems. Tell your doctor right away if you or your||
2498|079|S|family/caregiver notice any unusual/sudden changes in your mood,||
2498|080|S|thoughts, or behavior including signs of depression, suicidal||
2498|081|S|thoughts/attempts, thoughts about harming yourself.||
2498|082|S|   Rarely, topiramate may cause a very serious eye problem,||
2498|083|S|usually within 1 month of starting treatment. This eye problem||
2498|084|S|can lead to permanent blindness. Get medical help right away if||
2498|085|S|any of these side effects occur: sudden vision changes (such as||
2498|086|S|decreased vision, blurred vision), eye pain/redness.||
2498|087|S|   This medication can rarely cause a serious metabolic problem||
2498|088|S|(high amount of ammonia in the blood), especially if you are also||
2498|089|S|taking valproic acid. Tell your doctor right away if you||
2498|090|S|experience sudden/unexplained tiredness, vomiting, or mental||
2498|091|S|changes (such as decreased alertness).||
2498|092|S|   A very serious allergic reaction to this drug is rare.||
2498|093|S|However, get medical help right away if you notice any symptoms||
2498|094|S|of a serious allergic reaction, including: rash, itching/swelling||
2498|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2498|096|S|breathing.||
2498|097|S|   This is not a complete list of possible side effects. If you||
2498|098|S|notice other effects not listed above, contact your doctor or||
2498|099|S|pharmacist.||
2498|100|S|   In the US -||
2498|101|S|   Call your doctor for medical advice about side effects. You||
2498|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2498|103|S|www.fda.gov/medwatch.||
2498|104|S|   In Canada - Call your doctor for medical advice about side||
2498|105|S|effects. You may report side effects to Health Canada at||
2498|106|S|1-866-234-2345.||
2498|107|B|||
2498|108|P|PRECAUTIONS:  Before taking topiramate, tell your doctor or||
2498|109|P|pharmacist if you are allergic to it; or if you have any other||
2498|110|P|allergies. This product may contain inactive ingredients, which||
2498|111|P|can cause allergic reactions or other problems. Talk to your||
2498|112|P|pharmacist for more details.||
2498|113|P|   Before using this medication, tell your doctor or pharmacist||
2498|114|P|your medical history, especially of: a certain eye problem||
2498|115|P|(narrow angle glaucoma), kidney problems (such as kidney stones),||
2498|116|P|liver problems, mental/mood problems (such as depression,||
2498|117|P|thoughts of suicide), lung/breathing problems, a certain||
2498|118|P|metabolic imbalance (metabolic acidosis), long-term diarrhea, a||
2498|119|P|diet high in fat and low in carbohydrates (ketogenic diet),||
2498|120|P|brittle bones (osteoporosis).||
2498|121|P|   This drug may make you dizzy or drowsy or impair your||
2498|122|P|judgment. Alcohol or marijuana (cannabis) can worsen these||
2498|123|P|effects. Do not drive, use machinery, or do anything that needs||
2498|124|P|alertness until you can do it safely. Avoid alcoholic beverages.||
2498|125|P|Talk to your doctor if you are using marijuana (cannabis).||
2498|126|P|   This medication may make you sweat less, making you more||
2498|127|P|likely to get heat stroke. Avoid doing things that may cause you||
2498|128|P|to overheat, such as hard work or exercise in hot weather, or||
2498|129|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2498|130|P|and dress lightly. If you overheat, quickly look for a place to||
2498|131|P|cool down and rest. Get medical help right away if you have a||
2498|132|P|fever that does not go away, mental/mood changes, headache, or||
2498|133|P|dizziness.||
2498|134|P|   Before having surgery, tell your doctor or dentist about all||
2498|135|P|the products you use (including prescription drugs,||
2498|136|P|nonprescription drugs, and herbal products).||
2498|137|P|   Children may be more sensitive to the side effects of this||
2498|138|P|drug, especially weakened bones, slowed growth rate, and||
2498|139|P|decreased sweating. Consult your doctor or pharmacist for more||
2498|140|P|details.||
2498|141|P|   Older adults may be more sensitive to the side effects of this||
2498|142|P|drug, especially dizziness. Dizziness can increase the risk of||
2498|143|P|falling.||
2498|144|P|   During pregnancy, this medication should be used only when||
2498|145|P|clearly needed. It may harm an unborn baby. Discuss the use of||
2498|146|P|reliable forms of birth control with your doctor (see also Drug||
2498|147|P|Interactions section). If you are planning pregnancy, become||
2498|148|P|pregnant, or think you may be pregnant, immediately talk to your||
2498|149|P|doctor about the benefits and risks of using this medication||
2498|150|P|during pregnancy. If you are taking this drug to treat seizures,||
2498|151|P|note that untreated seizures are a serious condition that can||
2498|152|P|harm both a pregnant woman and her unborn baby, so do not stop||
2498|153|P|taking this medication unless directed by your doctor.||
2498|154|P|   This medication passes into breast milk and may have||
2498|155|P|undesirable effects on a nursing infant. Consult your doctor||
2498|156|P|before breastfeeding.||
2498|157|B|||
2498|158|I|DRUG INTERACTIONS:  See also Side Effects section.||
2498|159|I|   Drug interactions may change how your medications work or||
2498|160|I|increase your risk for serious side effects. This document does||
2498|161|I|not contain all possible drug interactions. Keep a list of all||
2498|162|I|the products you use (including prescription/nonprescription||
2498|163|I|drugs and herbal products) and share it with your doctor and||
2498|164|I|pharmacist. Do not start, stop, or change the dosage of any||
2498|165|I|medicines without your doctor's approval.||
2498|166|I|   A product that may interact with this drug is: orlistat.||
2498|167|I|   This medication may decrease the effectiveness of hormonal||
2498|168|I|birth control such as pills, patch, or ring. This could cause||
2498|169|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2498|170|I|use reliable backup birth control methods while using this||
2498|171|I|medication. Also tell your doctor if you have any new spotting or||
2498|172|I|breakthrough bleeding, because these may be signs that your birth||
2498|173|I|control is not working well.||
2498|174|I|   Tell your doctor or pharmacist if you are taking other||
2498|175|I|products that cause drowsiness including alcohol, marijuana||
2498|176|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
2498|177|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
2498|178|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
2498|179|I|codeine).||
2498|180|I|   Check the labels on all your medicines (such as allergy or||
2498|181|I|cough-and-cold products) because they may contain ingredients||
2498|182|I|that cause drowsiness. Ask your pharmacist about using those||
2498|183|I|products safely.||
2498|184|B|||
2498|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2498|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2498|187|O|poison control center right away. US residents can call||
2498|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2498|189|O|Symptoms of overdose may include: severe drowsiness, loss of||
2498|190|O|consciousness.||
2498|191|B|||
2498|192|N|NOTES:  Do not share this medication with others.||
2498|193|N|   Lab and/or medical tests (such as eye exams, bicarbonate blood||
2498|194|N|level) should be done while you are taking this medication. Keep||
2498|195|N|all medical and lab appointments.||
2498|196|B|||
2498|197|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2498|198|D|remember. If it is within 6 hours of the next dose, skip the||
2498|199|D|missed dose. Take your next dose at the regular time. Do not||
2498|200|D|double the dose to catch up. If you miss more than one dose, call||
2498|201|D|your doctor for advice.||
2498|202|B|||
2498|203|R|STORAGE:  Store at room temperature. Once the bottle is opened,||
2498|204|R|this medication expires after 90 days. Keep all medications away||
2498|205|R|from children and pets.||
2498|206|R|   Do not flush medications down the toilet or pour them into a||
2498|207|R|drain unless instructed to do so. Properly discard this product||
2498|208|R|when it is expired or no longer needed. Consult your pharmacist||
2498|209|R|or local waste disposal company.||
2498|210|B|||
2498|211|M|MEDICAL ALERT:  Your condition can cause complications in a||
2498|212|M|medical emergency. For information about enrolling in MedicAlert,||
2498|213|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2498|214|B|||
2498|215|A|Information last revised September 2024.||
2498|216|A|Copyright(c) 2025 First Databank, Inc.||
2498|217|B|||
2499|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2499|002|Z|does NOT have all possible information about this product. This||
2499|003|Z|information does not assure that this product is safe, effective,||
2499|004|Z|or appropriate for you. This information is not individual||
2499|005|Z|medical advice and does not substitute for the advice of your||
2499|006|Z|health care professional. Always ask your health care||
2499|007|Z|professional for complete information about this product and your||
2499|008|Z|specific health needs.||
2499|009|B|||
2499|010|T|SODIUM OXYBATE EXTENDED-RELEASE GRANULES - ORAL||
2499|011|F|(SO-dee-um OX-eh-bait)||
2499|012|B|||
2499|013|C|COMMON BRAND NAME(S): Lumryz||
2499|014|B|||
2499|015|W|WARNING:  Sodium oxybate is a very powerful central nervous||
2499|016|W|system (CNS) depressant with a high risk of abuse. It may cause||
2499|017|W|slow/shallow breathing or severe drowsiness at recommended doses.||
2499|018|W|It must be used only for the purpose that your doctor prescribes.||
2499|019|W|It is against the law to use this drug for any other purposes.||
2499|020|W|Abuse or misuse of this drug can result in seizures, severe||
2499|021|W|difficulty breathing, loss of consciousness, and even death. It||
2499|022|W|must not be used with alcohol or other CNS depressants (see also||
2499|023|W|Drug Interactions section).||
2499|024|W|   To receive sodium oxybate in the United States, you must||
2499|025|W|understand, agree to, and carefully follow the requirements of||
2499|026|W|the REMS Program for this medication. If you live in Canada or||
2499|027|W|any other country, consult your doctor and pharmacist for your||
2499|028|W|country's regulations.||
2499|029|B|||
2499|030|U|USES:  See also Warning section.||
2499|031|U|   Sodium oxybate is used to treat narcolepsy, a condition that||
2499|032|U|causes severe daytime sleepiness. It can decrease daytime||
2499|033|U|sleepiness and also reduce the number of sudden short attacks of||
2499|034|U|weak/paralyzed muscles (known as cataplexy) that can occur in||
2499|035|U|patients with narcolepsy. This medication is also known as gamma||
2499|036|U|hydroxybutyrate (GHB).||
2499|037|B|||
2499|038|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2499|039|H|provided by your pharmacist before you start using sodium oxybate||
2499|040|H|and each time you get a refill. If you have any questions, ask||
2499|041|H|your doctor or pharmacist.||
2499|042|H|   Take this medication by mouth as directed by your doctor,||
2499|043|H|usually once at bedtime, at least 2 hours after eating. Since||
2499|044|H|sodium oxybate can cause you to suddenly fall asleep without||
2499|045|H|feeling drowsy first, take this medication while in bed and lie||
2499|046|H|down right away after taking your dose.||
2499|047|H|   Prepare your dose before bedtime as directed in the||
2499|048|H|Instructions for Use leaflet. Fill the mixing cup as directed||
2499|049|H|with water (one-third cup or 80 milliliters). Only use the mixing||
2499|050|H|cup that comes with your medication. Do not use hot water. Open a||
2499|051|H|packet and pour its contents into the mixing cup. Put the cap on||
2499|052|H|the mixing cup and twist to the right and make sure it is tightly||
2499|053|H|closed. Mix well by shaking the closed mixing cup for 60 seconds||
2499|054|H|(1 minute). Drink all of the mixture within 30 minutes of mixing.||
2499|055|H|Then add a small amount of water as directed, shake for 10||
2499|056|H|seconds, and drink right away to make sure you are getting all of||
2499|057|H|the drug. If you have children or pets in the house, be sure to||
2499|058|H|keep the mixed medication out of their reach if not using||
2499|059|H|immediately, as mixing cup cap is not child resistant.||
2499|060|H|   The dosage is based on your medical condition and response to||
2499|061|H|treatment. To reduce your risk of side effects, your doctor may||
2499|062|H|direct you to start this medication at a low dose and gradually||
2499|063|H|increase your dose. This process will continue until your doctor||
2499|064|H|has found the right dose for you. Follow your doctor's directions||
2499|065|H|carefully.||
2499|066|H|   Use this medication regularly to get the most benefit from it.||
2499|067|H|To help you remember, take it at the same time each night. Do not||
2499|068|H|increase your dose or use this drug more often or for longer than||
2499|069|H|prescribed. Your condition will not improve any faster, and your||
2499|070|H|risk of side effects will increase.||
2499|071|H|   If you suddenly stop using this medication, you may have||
2499|072|H|withdrawal symptoms (such as anxiety, psychosis, fast heartbeat,||
2499|073|H|trouble sleeping). To help prevent withdrawal, your doctor may||
2499|074|H|lower your dose slowly. Withdrawal is more likely if you have||
2499|075|H|used sodium oxybate for a long time or in high doses. Tell your||
2499|076|H|doctor or pharmacist right away if you have withdrawal.||
2499|077|H|   Tell your doctor if your condition lasts or gets worse.||
2499|078|B|||
2499|079|S|SIDE EFFECTS:  See also Warning section.||
2499|080|S|   Drowsiness, dizziness, nausea, vomiting, bedwetting, or||
2499|081|S|headache may occur. If any of these effects last or get worse,||
2499|082|S|tell your doctor or pharmacist promptly.||
2499|083|S|   Remember that this medication has been prescribed because your||
2499|084|S|doctor has judged that the benefit to you is greater than the||
2499|085|S|risk of side effects. Many people using this medication do not||
2499|086|S|have serious side effects.||
2499|087|S|   Tell your doctor right away if you have any serious side||
2499|088|S|effects, including: mental/mood changes (such as confusion,||
2499|089|S|psychosis, hallucinations, agitation, depression, thoughts of||
2499|090|S|suicide), sleepwalking.||
2499|091|S|   Get medical help right away if you have any very serious side||
2499|092|S|effects, including: difficult/slow/shallow breathing (especially||
2499|093|S|during sleep).||
2499|094|S|   A very serious allergic reaction to this drug is rare.||
2499|095|S|However, get medical help right away if you notice any symptoms||
2499|096|S|of a serious allergic reaction, including: rash, itching/swelling||
2499|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2499|098|S|breathing.||
2499|099|S|   This is not a complete list of possible side effects. If you||
2499|100|S|notice other effects not listed above, contact your doctor or||
2499|101|S|pharmacist.||
2499|102|S|   In the US -||
2499|103|S|   Call your doctor for medical advice about side effects. You||
2499|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2499|105|S|www.fda.gov/medwatch.||
2499|106|S|   In Canada - Call your doctor for medical advice about side||
2499|107|S|effects. You may report side effects to Health Canada at||
2499|108|S|1-866-234-2345.||
2499|109|B|||
2499|110|P|PRECAUTIONS:  Before taking sodium oxybate, tell your doctor or||
2499|111|P|pharmacist if you are allergic to it; or if you have any other||
2499|112|P|allergies. This product may contain inactive ingredients, which||
2499|113|P|can cause allergic reactions or other problems. Talk to your||
2499|114|P|pharmacist for more details.||
2499|115|P|   Before using this medication, tell your doctor or pharmacist||
2499|116|P|your medical history, especially of: a certain rare metabolic||
2499|117|P|condition (succinic semialdehyde dehydrogenase deficiency), liver||
2499|118|P|disease, kidney disease, breathing problems (such as sleep apnea,||
2499|119|P|asthma), personal or family history of a substance use disorder||
2499|120|P|(such as overuse of or addiction to drugs/alcohol), heart||
2499|121|P|problems (such as heart failure, high blood pressure),||
2499|122|P|mental/mood problems (such as depression, family/personal history||
2499|123|P|of suicidal thoughts/attempts).||
2499|124|P|   Sleep disorders may decrease your ability to react quickly.||
2499|125|P|Though sodium oxybate helps keep you awake during the day, you||
2499|126|P|still may not be able to safely perform tasks that require||
2499|127|P|alertness (such as driving, flying). This drug may also make you||
2499|128|P|dizzy. Alcohol or marijuana (cannabis) can make you more dizzy.||
2499|129|P|For these reasons, do not drive, use machinery, or do anything||
2499|130|P|that needs alertness until you can do it safely. Always use great||
2499|131|P|care when doing these activities, and avoid them completely||
2499|132|P|during the first 6 hours after you take this medication. Avoid||
2499|133|P|alcoholic beverages because they increase the risk of serious||
2499|134|P|side effects. Talk to your doctor if you are using marijuana||
2499|135|P|(cannabis).||
2499|136|P|   This medication contains sodium. Consult your doctor for more||
2499|137|P|information if you are on a salt-restricted diet or if you have a||
2499|138|P|condition that could be worsened by increased salt intake (such||
2499|139|P|as heart failure, high blood pressure).||
2499|140|P|   Before having surgery, tell your doctor or dentist about all||
2499|141|P|the products you use (including prescription drugs,||
2499|142|P|nonprescription drugs, and herbal products).||
2499|143|P|   Older adults may be more sensitive to the side effects of this||
2499|144|P|drug, especially headaches.||
2499|145|P|   During pregnancy, this medication should be used only when||
2499|146|P|clearly needed. Discuss the risks and benefits with your doctor.||
2499|147|P|   This drug passes into breast milk. Consult your doctor before||
2499|148|P|breastfeeding.||
2499|149|B|||
2499|150|I|DRUG INTERACTIONS:  See also Warning section.||
2499|151|I|   Drug interactions may change how your medications work or||
2499|152|I|increase your risk for serious side effects. This document does||
2499|153|I|not contain all possible drug interactions. Keep a list of all||
2499|154|I|the products you use (including prescription/nonprescription||
2499|155|I|drugs and herbal products) and share it with your doctor and||
2499|156|I|pharmacist. Do not start, stop, or change the dosage of any||
2499|157|I|medicines without your doctor's approval.||
2499|158|I|   The risk of serious side effects (such as slow/shallow||
2499|159|I|breathing, severe drowsiness/dizziness) may be increased if this||
2499|160|I|medication is taken with other products that may also cause||
2499|161|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2499|162|I|if you are using other products such as other opioid pain or||
2499|163|I|cough relievers (such as codeine, hydrocodone), alcohol,||
2499|164|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
2499|165|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2499|166|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2499|167|I|cetirizine, diphenhydramine).||
2499|168|I|   Check the labels on all your medicines (such as allergy or||
2499|169|I|cough-and-cold products) because they may contain ingredients||
2499|170|I|that cause drowsiness. Ask your pharmacist about using those||
2499|171|I|products safely.||
2499|172|B|||
2499|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2499|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2499|175|O|poison control center right away. US residents can call||
2499|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2499|177|O|Symptoms of overdose may include: lack of response, slow/shallow||
2499|178|O|breathing, seizures.||
2499|179|B|||
2499|180|N|NOTES:  Do not share this medication with others. Sharing it is||
2499|181|N|against the law.||
2499|182|B|||
2499|183|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2499|184|D|next dose at the regular time. Do not double the dose to catch||
2499|185|D|up.||
2499|186|B|||
2499|187|R|STORAGE:  Store at room temperature away from light and moisture.||
2499|188|R|Do not store in the bathroom. Do not open the packets until you||
2499|189|R|are ready to use the medication. Keep all medications away from||
2499|190|R|children and pets.||
2499|191|R|   Do not flush medications down the toilet or pour them into a||
2499|192|R|drain unless instructed to do so. Properly discard this product||
2499|193|R|when it is expired or no longer needed. For more details, read||
2499|194|R|the Instructions for Use leaflet, or consult your pharmacist or||
2499|195|R|local waste disposal company.||
2499|196|B|||
2499|197|A|Information last revised September 2024.||
2499|198|A|Copyright(c) 2025 First Databank, Inc.||
2499|199|B|||
2500|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2500|002|Z|does NOT have all possible information about this product. This||
2500|003|Z|information does not assure that this product is safe, effective,||
2500|004|Z|or appropriate for you. This information is not individual||
2500|005|Z|medical advice and does not substitute for the advice of your||
2500|006|Z|health care professional. Always ask your health care||
2500|007|Z|professional for complete information about this product and your||
2500|008|Z|specific health needs.||
2500|009|B|||
2500|010|T|FECAL MICROBIOTA SPORES (LIVE) - ORAL||
2500|011|B|||
2500|012|C|COMMON BRAND NAME(S): Vowst||
2500|013|B|||
2500|014|U|USES:  This product is used to help prevent a certain infection||
2500|015|U|in the intestines (C. difficile-CDI) from coming back after||
2500|016|U|completing antibiotics for a return of the infection. This||
2500|017|U|product is made from human stool from screened donors. It is||
2500|018|U|thought to work by giving you healthy bacteria.||
2500|019|U|   This product is not used for treatment of CDI.||
2500|020|B|||
2500|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2500|022|H|from your pharmacist before you start taking this product and||
2500|023|H|each time you get a refill. If you have any questions, ask your||
2500|024|H|doctor or pharmacist.||
2500|025|H|   Take this product by mouth on an empty stomach as directed by||
2500|026|H|your doctor, usually once daily before the first meal of the day||
2500|027|H|for 3 days. Do not eat or drink, except for a small amount of||
2500|028|H|water, for at least 8 hours before taking the first dose. Swallow||
2500|029|H|the capsules whole. Do not crush, chew, or break the capsules.||
2500|030|H|   Your doctor will direct you to take a laxative (such as||
2500|031|H|magnesium citrate or polyethylene glycol) at least 8 hours before||
2500|032|H|you take your first dose. Carefully follow your doctor's||
2500|033|H|directions for all of your medications.||
2500|034|H|   This product contains live bacteria, so antibiotics may||
2500|035|H|prevent it from working well. Do not take any antibiotics while||
2500|036|H|taking this product, unless directed by your doctor.||
2500|037|H|   Continue to take this product until the full prescribed amount||
2500|038|H|is finished. Tell your doctor if your condition lasts or gets||
2500|039|H|worse.||
2500|040|B|||
2500|041|S|SIDE EFFECTS:  Bloating, tiredness, constipation, chills, or||
2500|042|S|diarrhea may occur. If any of these effects last or get worse,||
2500|043|S|tell your doctor or pharmacist promptly.||
2500|044|S|   Remember that this product has been prescribed because your||
2500|045|S|doctor has judged that the benefit to you is greater than the||
2500|046|S|risk of side effects. Many people using this product do not have||
2500|047|S|serious side effects.||
2500|048|S|   A very serious allergic reaction to this drug is rare.||
2500|049|S|However, get medical help right away if you notice any symptoms||
2500|050|S|of a serious allergic reaction, including: rash, itching/swelling||
2500|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2500|052|S|breathing.||
2500|053|S|   This is not a complete list of possible side effects. If you||
2500|054|S|notice other effects not listed above, contact your doctor or||
2500|055|S|pharmacist.||
2500|056|S|   In the US -||
2500|057|S|   Call your doctor for medical advice about side effects. You||
2500|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2500|059|S|www.fda.gov/medwatch.||
2500|060|S|   In Canada - Call your doctor for medical advice about side||
2500|061|S|effects. You may report side effects to Health Canada at||
2500|062|S|1-866-234-2345.||
2500|063|B|||
2500|064|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2500|065|P|pharmacist if you are allergic to it; or if you have any other||
2500|066|P|allergies. This product may contain inactive ingredients, which||
2500|067|P|can cause allergic reactions or other problems. Talk to your||
2500|068|P|pharmacist for more details.||
2500|069|P|   Before using this product, tell your doctor or pharmacist your||
2500|070|P|medical history, especially of: kidney disease.||
2500|071|P|   Before having surgery, tell your doctor or dentist about all||
2500|072|P|the products you use (including prescription drugs,||
2500|073|P|nonprescription drugs, and herbal products).||
2500|074|P|   During pregnancy, this product should be used only when||
2500|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
2500|076|P|   It is unknown if this product passes into breast milk. Consult||
2500|077|P|your doctor before breastfeeding.||
2500|078|B|||
2500|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2500|080|I|medications work or increase your risk for serious side effects.||
2500|081|I|This document does not contain all possible drug interactions.||
2500|082|I|Keep a list of all the products you use (including||
2500|083|I|prescription/nonprescription drugs and herbal products) and share||
2500|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
2500|085|I|the dosage of any medicines without your doctor's approval.||
2500|086|B|||
2500|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2500|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2500|089|O|poison control center right away. US residents can call||
2500|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2500|091|B|||
2500|092|N|NOTES:  Do not share this product with others.||
2500|093|N|   Lab and/or medical tests (such as stool tests) may be done||
2500|094|N|while you are taking this product. Keep all medical and lab||
2500|095|N|appointments. Consult your doctor for more details.||
2500|096|B|||
2500|097|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2500|098|D|remember. If it is near the time of the next dose, skip the||
2500|099|D|missed dose. Take your next dose at the regular time. Do not||
2500|100|D|double the dose to catch up.||
2500|101|B|||
2500|102|R|STORAGE:  Store in the original container in the refrigerator or||
2500|103|R|at room temperature away from light and moisture. Do not freeze.||
2500|104|R|Do not store in the bathroom. Keep all medications away from||
2500|105|R|children and pets.||
2500|106|R|   Do not flush medications down the toilet or pour them into a||
2500|107|R|drain unless instructed to do so. Properly discard this product||
2500|108|R|when it is expired or no longer needed. Consult your pharmacist||
2500|109|R|or local waste disposal company.||
2500|110|B|||
2500|111|A|Information last revised May 2024.||
2500|112|A|Copyright(c) 2025 First Databank, Inc.||
2500|113|B|||
2501|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2501|002|Z|does NOT have all possible information about this product. This||
2501|003|Z|information does not assure that this product is safe, effective,||
2501|004|Z|or appropriate for you. This information is not individual||
2501|005|Z|medical advice and does not substitute for the advice of your||
2501|006|Z|health care professional. Always ask your health care||
2501|007|Z|professional for complete information about this product and your||
2501|008|Z|specific health needs.||
2501|009|B|||
2501|010|T|SOMAPACITAN - INJECTION||
2501|011|F|(SOE-ma-PAS-i-tan)||
2501|012|B|||
2501|013|C|COMMON BRAND NAME(S): Sogroya||
2501|014|B|||
2501|015|U|USES:  This medication is used to treat certain conditions||
2501|016|U|(growth hormone deficiency, growth failure) in people who do not||
2501|017|U|make enough growth hormone. Growth hormone is normally produced||
2501|018|U|in the brain by a certain gland (pituitary gland) and has various||
2501|019|U|effects on development in the body. A lack of growth hormone in||
2501|020|U|children results in slowed growth and short height for the||
2501|021|U|child's age. A lack of growth hormone in adults may lead to an||
2501|022|U|increase in body fat. Somapacitan works by providing more growth||
2501|023|U|hormone, which may help the long bones (such as the arms and||
2501|024|U|legs) grow longer in children and help reduce body fat in adults.||
2501|025|B|||
2501|026|H|HOW TO USE:  Read the Patient Information Leaflet and||
2501|027|H|Instructions for Use if available from your pharmacist before you||
2501|028|H|start using somapacitan and each time you get a refill. Ask your||
2501|029|H|health care professional how to prepare and use this medication.||
2501|030|H|If you have any questions, ask your doctor or pharmacist.||
2501|031|H|   Inject this medication under the skin as directed by your||
2501|032|H|doctor, usually once weekly. The injection is given in the||
2501|033|H|abdomen, thighs, buttocks, or upper arms. The dosage is based on||
2501|034|H|your medical condition, age, weight, and response to treatment.||
2501|035|H|To reduce your risk of side effects, your doctor may direct you||
2501|036|H|to start this medication at a low dose and gradually increase||
2501|037|H|your dose. Follow your doctor's instructions carefully.||
2501|038|H|    Before using, check this product for particles or||
2501|039|H|discoloration. If either is present, do not use the liquid.||
2501|040|H|Before injecting each dose, clean the skin you are going to||
2501|041|H|inject into (the injection site) with rubbing alcohol. Change the||
2501|042|H|injection site each time to lessen injury under the skin. To||
2501|043|H|lessen bruising, do not rub the injection site after a shot.||
2501|044|H|Learn how to store and discard medical supplies safely.||
2501|045|H|   Do not share your device with another person, even if the||
2501|046|H|needle is changed. You may give other people a serious infection,||
2501|047|H|or get a serious infection from them.||
2501|048|H|   Use this medication regularly to get the most benefit from it.||
2501|049|H|To help you remember, mark your calendar with a reminder.||
2501|050|B|||
2501|051|S|SIDE EFFECTS:  Pain, redness, itching, swelling, or thickening of||
2501|052|S|the skin at the injection site may occur. Headache, fever,||
2501|053|S|dizziness, or joint/back pain may also occur. If any of these||
2501|054|S|effects last or get worse, tell your doctor or pharmacist||
2501|055|S|promptly.||
2501|056|S|   Remember that this medication has been prescribed because your||
2501|057|S|doctor has judged that the benefit to you is greater than the||
2501|058|S|risk of side effects. Many people using this medication do not||
2501|059|S|have serious side effects.||
2501|060|S|   Tell your doctor right away if you have any serious side||
2501|061|S|effects, including: nausea/vomiting that doesn't stop, severe||
2501|062|S|stomach/abdominal pain that doesn't stop, development of a limp,||
2501|063|S|hip/knee pain, increased thirst/frequent urination, swelling of||
2501|064|S|the hands/ankles/feet, numbness/tingling, symptoms of thyroid||
2501|065|S|problems (such as cold intolerance, unexplained increased||
2501|066|S|weight).||
2501|067|S|   Somapacitan may increase your risk of getting a new tumor or||
2501|068|S|cancer. Children who have had brain/head radiation treatment for||
2501|069|S|cancer should be monitored for new tumors/cancers. Tell your||
2501|070|S|doctor right away if you or a caregiver notice symptoms such as||
2501|071|S|unusual changes in behavior, vision problems/changes, severe||
2501|072|S|headache, changes in skin color, or change in the appearance or||
2501|073|S|size of a mole. Talk with your doctor for details and to discuss||
2501|074|S|the risks and benefits of this medication.||
2501|075|S|   A very serious allergic reaction to this drug is rare.||
2501|076|S|However, get medical help right away if you notice any symptoms||
2501|077|S|of a serious allergic reaction, including: rash, itching/swelling||
2501|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2501|079|S|breathing.||
2501|080|S|   This is not a complete list of possible side effects. If you||
2501|081|S|notice other effects not listed above, contact your doctor or||
2501|082|S|pharmacist.||
2501|083|S|   In the US -||
2501|084|S|   Call your doctor for medical advice about side effects. You||
2501|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2501|086|S|www.fda.gov/medwatch.||
2501|087|S|   In Canada - Call your doctor for medical advice about side||
2501|088|S|effects. You may report side effects to Health Canada at||
2501|089|S|1-866-234-2345.||
2501|090|B|||
2501|091|P|PRECAUTIONS:  See also Side Effects section.||
2501|092|P|   Before using somapacitan, tell your doctor or pharmacist if||
2501|093|P|you are allergic to it; or to somatropin; or if you have any||
2501|094|P|other allergies. This product may contain inactive ingredients,||
2501|095|P|which can cause allergic reactions or other problems. Talk to||
2501|096|P|your pharmacist for more details.||
2501|097|P|   Before using this medication, tell your doctor or pharmacist||
2501|098|P|your medical history, especially of: recent major surgery/injury,||
2501|099|P|cancer (especially of the head/neck), eye problems (such as||
2501|100|P|diabetic retinopathy), Prader-Willi syndrome, diabetes, kidney||
2501|101|P|disease, liver disease, adrenal gland problems, thyroid problems,||
2501|102|P|a certain back problem (scoliosis).||
2501|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2501|104|P|can make you more dizzy. Do not drive, use machinery, or do||
2501|105|P|anything that needs alertness until you can do it safely. Limit||
2501|106|P|alcoholic beverages. Talk to your doctor if you are using||
2501|107|P|marijuana (cannabis).||
2501|108|P|   If you have diabetes, this drug may increase your blood sugar.||
2501|109|P|Check your blood sugar regularly as directed and share the||
2501|110|P|results with your doctor. Tell your doctor right away if you have||
2501|111|P|symptoms of high blood sugar such as increased thirst/urination.||
2501|112|P|Your doctor may need to adjust your diabetes medication, exercise||
2501|113|P|program, or diet.||
2501|114|P|   Before having surgery, tell your doctor or dentist about all||
2501|115|P|the products you use (including prescription drugs,||
2501|116|P|nonprescription drugs, and herbal products).||
2501|117|P|   During pregnancy, this medication should be used only when||
2501|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
2501|119|P|   It is unknown if this drug passes into breast milk. Consult||
2501|120|P|your doctor before breastfeeding.||
2501|121|B|||
2501|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2501|123|I|medications work or increase your risk for serious side effects.||
2501|124|I|This document does not contain all possible drug interactions.||
2501|125|I|Keep a list of all the products you use (including||
2501|126|I|prescription/nonprescription drugs and herbal products) and share||
2501|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
2501|128|I|the dosage of any medicines without your doctor's approval.||
2501|129|B|||
2501|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2501|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2501|132|O|poison control center right away. US residents can call||
2501|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2501|134|B|||
2501|135|N|NOTES:  Do not share this medication with others.||
2501|136|N|   Lab and/or medical tests (such as growth factor blood tests,||
2501|137|N|thyroid function, blood sugar, cortisol level, eye exam) may be||
2501|138|N|done before you start using this medication and while you are||
2501|139|N|using it. Keep all medical and lab appointments.||
2501|140|B|||
2501|141|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2501|142|D|If it is more than 3 days after the missed dose, skip the missed||
2501|143|D|dose. Use your next dose on the regular scheduled day. Do not||
2501|144|D|double the dose to catch up.||
2501|145|B|||
2501|146|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2501|147|R|medication in the original carton to protect from light. This||
2501|148|R|medication may be taken out of the refrigerator and put back in||
2501|149|R|the refrigerator if needed. The total time out of the||
2501|150|R|refrigerator should not be more than 3 days. Discard medication 6||
2501|151|R|weeks after first use, even if the pen device contains unused||
2501|152|R|medication. Keep all medications away from children and pets.||
2501|153|R|   Do not flush medications down the toilet or pour them into a||
2501|154|R|drain unless instructed to do so. Properly discard this product||
2501|155|R|when it is expired or no longer needed. Consult your pharmacist||
2501|156|R|or local waste disposal company.||
2501|157|B|||
2501|158|A|Information last revised October 2024.||
2501|159|A|Copyright(c) 2025 First Databank, Inc.||
2501|160|B|||
2502|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2502|002|Z|does NOT have all possible information about this product. This||
2502|003|Z|information does not assure that this product is safe, effective,||
2502|004|Z|or appropriate for you. This information is not individual||
2502|005|Z|medical advice and does not substitute for the advice of your||
2502|006|Z|health care professional. Always ask your health care||
2502|007|Z|professional for complete information about this product and your||
2502|008|Z|specific health needs.||
2502|009|B|||
2502|010|T|FEZOLINETANT - ORAL||
2502|011|B|||
2502|012|C|COMMON BRAND NAME(S): Veozah||
2502|013|B|||
2502|014|W|WARNING:  Fezolinetant may rarely cause serious liver disease.||
2502|015|W|Your doctor will test your liver function before you start taking||
2502|016|W|this medication and while you are taking it. Stop taking this||
2502|017|W|medication and tell your doctor right away if you have any||
2502|018|W|symptoms of liver damage, including nausea/vomiting that doesn't||
2502|019|W|stop, loss of appetite, severe stomach/abdominal pain, yellowing||
2502|020|W|eyes/skin, or dark urine.||
2502|021|B|||
2502|022|U|USES:  This medication is used to help reduce certain symptoms of||
2502|023|U|menopause (such as hot flashes, night sweats). Fezolinetant works||
2502|024|U|by blocking a certain chemical (neurokinin B-NKB) in the||
2502|025|U|temperature control area of the brain that can cause hot flashes||
2502|026|U|and night sweats.||
2502|027|B|||
2502|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2502|029|H|from your pharmacist before you start taking fezolinetant and||
2502|030|H|each time you get a refill. If you have any questions, ask your||
2502|031|H|doctor or pharmacist.||
2502|032|H|   Take this medication by mouth with or without food as directed||
2502|033|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2502|034|H|not cut, crush, or chew the tablets.||
2502|035|H|   Use this medication regularly to get the most benefit from it.||
2502|036|H|To help you remember, take it at the same time each day.||
2502|037|H|   Do not increase your dose or use this drug more often or for||
2502|038|H|longer than prescribed. Your condition will not improve any||
2502|039|H|faster, and your risk of side effects will increase.||
2502|040|H|   Tell your doctor if your condition lasts or gets worse.||
2502|041|B|||
2502|042|S|SIDE EFFECTS:  See also Warning section.||
2502|043|S|   Abdominal pain or trouble sleeping may occur. If either of||
2502|044|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2502|045|S|promptly.||
2502|046|S|   Remember that this medication has been prescribed because your||
2502|047|S|doctor has judged that the benefit to you is greater than the||
2502|048|S|risk of side effects. Many people using this medication do not||
2502|049|S|have serious side effects.||
2502|050|S|   A very serious allergic reaction to this drug is rare.||
2502|051|S|However, get medical help right away if you notice any symptoms||
2502|052|S|of a serious allergic reaction, including: rash, itching/swelling||
2502|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2502|054|S|breathing.||
2502|055|S|   This is not a complete list of possible side effects. If you||
2502|056|S|notice other effects not listed above, contact your doctor or||
2502|057|S|pharmacist.||
2502|058|S|   In the US -||
2502|059|S|   Call your doctor for medical advice about side effects. You||
2502|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2502|061|S|www.fda.gov/medwatch.||
2502|062|S|   In Canada - Call your doctor for medical advice about side||
2502|063|S|effects. You may report side effects to Health Canada at||
2502|064|S|1-866-234-2345.||
2502|065|B|||
2502|066|P|PRECAUTIONS:  Before taking fezolinetant, tell your doctor or||
2502|067|P|pharmacist if you are allergic to it; or if you have any other||
2502|068|P|allergies. This product may contain inactive ingredients, which||
2502|069|P|can cause allergic reactions or other problems. Talk to your||
2502|070|P|pharmacist for more details.||
2502|071|P|   Before using this medication, tell your doctor or pharmacist||
2502|072|P|your medical history, especially of: liver disease (such as||
2502|073|P|cirrhosis), kidney problems.||
2502|074|P|   Before having surgery, tell your doctor or dentist about all||
2502|075|P|the products you use (including prescription drugs,||
2502|076|P|nonprescription drugs, and herbal products).||
2502|077|P|   This medication is not usually used by women of childbearing||
2502|078|P|age. It is unlikely to be used during pregnancy or breastfeeding.||
2502|079|P|Consult your doctor if you have any questions about this||
2502|080|P|medication.||
2502|081|B|||
2502|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2502|083|I|medications work or increase your risk for serious side effects.||
2502|084|I|This document does not contain all possible drug interactions.||
2502|085|I|Keep a list of all the products you use (including||
2502|086|I|prescription/nonprescription drugs and herbal products) and share||
2502|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
2502|088|I|the dosage of any medicines without your doctor's approval.||
2502|089|I|   Other medications can affect the removal of fezolinetant from||
2502|090|I|your body, which may affect how fezolinetant works. Examples||
2502|091|I|include capmatinib, ciprofloxacin, estrogens (such as estradiol,||
2502|092|I|conjugated estrogens), fluvoxamine, certain H2 blockers (such as||
2502|093|I|cimetidine, famotidine), mexiletine, propranolol, ribociclib,||
2502|094|I|rucaparib, verapamil, among others.||
2502|095|B|||
2502|096|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2502|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2502|098|O|poison control center right away. US residents can call||
2502|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2502|100|B|||
2502|101|N|NOTES:  Do not share this medication with others.||
2502|102|N|   Lab and/or medical tests (such as liver/kidney function)||
2502|103|N|should be done before you start taking this medication and while||
2502|104|N|you are taking it. Keep all medical and lab appointments. Consult||
2502|105|N|your doctor for more details.||
2502|106|N|   Lifestyle changes that may help reduce hot flashes include||
2502|107|N|stopping smoking, dressing lightly or in layers,||
2502|108|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
2502|109|N|reducing stress, and exercising regularly.||
2502|110|B|||
2502|111|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2502|112|D|remember. If it is less than 12 hours before the next dose, skip||
2502|113|D|the missed dose. Take your next dose at the regular time. Do not||
2502|114|D|double the dose to catch up.||
2502|115|B|||
2502|116|R|STORAGE:  Store at room temperature away from light and moisture.||
2502|117|R|Do not store in the bathroom. Keep all medications away from||
2502|118|R|children and pets.||
2502|119|R|   Do not flush medications down the toilet or pour them into a||
2502|120|R|drain unless instructed to do so. Properly discard this product||
2502|121|R|when it is expired or no longer needed. Consult your pharmacist||
2502|122|R|or local waste disposal company.||
2502|123|B|||
2502|124|A|Information last revised October 2025.||
2502|125|A|Copyright(c) 2025 First Databank, Inc.||
2502|126|B|||
2503|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2503|002|Z|does NOT have all possible information about this product. This||
2503|003|Z|information does not assure that this product is safe, effective,||
2503|004|Z|or appropriate for you. This information is not individual||
2503|005|Z|medical advice and does not substitute for the advice of your||
2503|006|Z|health care professional. Always ask your health care||
2503|007|Z|professional for complete information about this product and your||
2503|008|Z|specific health needs.||
2503|009|B|||
2503|010|T|RESPIRATORY SYNCYTIAL VIRUS VACCINE - INJECTION||
2503|011|B|||
2503|012|C|COMMON BRAND NAME(S): Abrysvo, Arexvy, Mresvia||
2503|013|B|||
2503|014|U|USES:  This vaccine is used to help prevent infection by the||
2503|015|U|respiratory syncytial virus (RSV). It may also be used during the||
2503|016|U|third trimester of pregnancy to help prevent RSV in the newborn||
2503|017|U|baby. RSV can cause serious illness, especially in older adults||
2503|018|U|with certain health problems (such as heart disease, lung||
2503|019|U|disease) and infants. This vaccine works by increasing the body's||
2503|020|U|natural defense (immunity) against the virus.||
2503|021|U|   Vaccines may not fully protect everyone who receives them.||
2503|022|B|||
2503|023|H|HOW TO USE:  Read all vaccine information available from your||
2503|024|H|health care professional before receiving the vaccine. If you||
2503|025|H|have any questions, ask your health care professional.||
2503|026|H|   The vaccine is given by injection into a muscle in the upper||
2503|027|H|arm by a health care professional.||
2503|028|B|||
2503|029|S|SIDE EFFECTS:  Soreness/redness/swelling/bruising at the||
2503|030|S|injection site, muscle aches, joint pain, headache, or tiredness||
2503|031|S|may occur. If any of these effects last or get worse, tell your||
2503|032|S|health care professional promptly.||
2503|033|S|   Rarely, some people have symptoms such as fainting, dizziness,||
2503|034|S|vision changes, or ringing in the ears just after getting a||
2503|035|S|vaccine injection. Tell your health care professional right away||
2503|036|S|if you have any of these symptoms. Sitting or lying down may||
2503|037|S|help, since these symptoms usually don't last long.||
2503|038|S|   Remember that this vaccine has been prescribed because your||
2503|039|S|health care professional has judged that the benefit to you is||
2503|040|S|greater than the risk of side effects. Many people using this||
2503|041|S|vaccine do not have serious side effects.||
2503|042|S|   A very serious allergic reaction to this vaccine is rare.||
2503|043|S|However, get medical help right away if you notice any symptoms||
2503|044|S|of a serious allergic reaction, including: rash, itching/swelling||
2503|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2503|046|S|breathing.||
2503|047|S|   This is not a complete list of possible side effects. If you||
2503|048|S|notice other effects not listed above, contact your health care||
2503|049|S|professional.||
2503|050|S|   Contact the doctor for medical advice about side effects. The||
2503|051|S|following numbers do not provide medical advice, but in the US||
2503|052|S|you may report side effects to the Vaccine Adverse Event||
2503|053|S|Reporting System (VAERS) at 1-800-822-7967. In Canada, you may||
2503|054|S|call the Vaccine Safety Section at Public Health Agency of Canada||
2503|055|S|at 1-866-844-0018.||
2503|056|B|||
2503|057|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
2503|058|P|care professional if you are allergic to it; or if you have any||
2503|059|P|other allergies. This product may contain inactive ingredients,||
2503|060|P|which can cause allergic reactions or other problems. Talk to||
2503|061|P|your health care professional for more details.||
2503|062|P|   Before receiving this vaccine, tell your health care||
2503|063|P|professional your medical history, especially of: current||
2503|064|P|fever/illness, immune system disorders (such as due to HIV||
2503|065|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
2503|066|P|radiation treatment), vaccination history (including previous||
2503|067|P|reactions to any vaccines).||
2503|068|P|   During pregnancy, this vaccine should be used only when||
2503|069|P|clearly needed. This vaccine may be given during the third||
2503|070|P|trimester (after 32 weeks) to help prevent RSV in the newborn||
2503|071|P|baby. Discuss the risks and benefits with your health care||
2503|072|P|professional.||
2503|073|P|   It is unknown if this vaccine passes into breast milk. Consult||
2503|074|P|your health care professional before breastfeeding.||
2503|075|B|||
2503|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2503|077|I|medications work or increase your risk for serious side effects.||
2503|078|I|This document does not contain all possible drug interactions.||
2503|079|I|Keep a list of all the products you use (including||
2503|080|I|prescription/nonprescription drugs and herbal products) and share||
2503|081|I|it with your health care professional. Do not start, stop, or||
2503|082|I|change the dosage of any medicines without your doctor's||
2503|083|I|approval.||
2503|084|I|   Some products that may interact with this vaccine are: drugs||
2503|085|I|that weaken the immune system (including cyclosporine,||
2503|086|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
2503|087|I|prednisone).||
2503|088|B|||
2503|089|O|OVERDOSE:  Not applicable.||
2503|090|B|||
2503|091|N|NOTES:  Keep all medical and lab appointments.||
2503|092|N|   Keep vaccine records for yourself and your children and||
2503|093|N|provide them to the health care professionals to prevent||
2503|094|N|unnecessary re-vaccinations.||
2503|095|B|||
2503|096|D|MISSED DOSE:  Not applicable.||
2503|097|B|||
2503|098|R|STORAGE:  Store in the refrigerator. Do not freeze. Protect from||
2503|099|R|light. Keep all medications away from children and pets.||
2503|100|R|   Do not flush medications down the toilet or pour them into a||
2503|101|R|drain unless instructed to do so. Properly discard this product||
2503|102|R|when it is expired or no longer needed. Consult your pharmacist||
2503|103|R|or local waste disposal company.||
2503|104|B|||
2503|105|A|Information last revised February 2025.||
2503|106|A|Copyright(c) 2025 First Databank, Inc.||
2503|107|B|||
2504|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2504|002|Z|does NOT have all possible information about this product. This||
2504|003|Z|information does not assure that this product is safe, effective,||
2504|004|Z|or appropriate for you. This information is not individual||
2504|005|Z|medical advice and does not substitute for the advice of your||
2504|006|Z|health care professional. Always ask your health care||
2504|007|Z|professional for complete information about this product and your||
2504|008|Z|specific health needs.||
2504|009|B|||
2504|010|T|EPCORITAMAB - INJECTION||
2504|011|B|||
2504|012|C|COMMON BRAND NAME(S): Epkinly||
2504|013|B|||
2504|014|W|WARNING:  Epcoritamab may cause a certain serious side effect||
2504|015|W|known as cytokine release syndrome-CRS. Tell your doctor right||
2504|016|W|away if you develop symptoms such as fever, chills, headache,||
2504|017|W|fast heartbeat, trouble breathing, unsteadiness, or||
2504|018|W|dizziness/lightheadedness.||
2504|019|W|   This medication can also cause serious (rarely fatal) nervous||
2504|020|W|system problems. Careful monitoring and prompt treatment may||
2504|021|W|decrease your risk. Tell your doctor right away if you have any||
2504|022|W|symptoms such as drowsiness, changes in your handwriting, or||
2504|023|W|shaking.||
2504|024|B|||
2504|025|U|USES:  This medication is used to treat certain types of cancer||
2504|026|U|(diffuse large B-cell lymphoma-DLBCL, high-grade B-cell lymphoma,||
2504|027|U|follicular lymphoma). Epcoritamab works by slowing or stopping||
2504|028|U|the growth of cancer cells.||
2504|029|B|||
2504|030|H|HOW TO USE:  Read the Medication Guide provided by your||
2504|031|H|pharmacist before you start using epcoritamab and each time you||
2504|032|H|get a treatment. If you have any questions, ask your doctor or||
2504|033|H|pharmacist.||
2504|034|H|   This medication is given by injection under the skin of the||
2504|035|H|abdomen or thigh by a health care professional. To reduce your||
2504|036|H|risk of side effects, your doctor will start this medication at a||
2504|037|H|low dose and gradually increase your dose. These starting doses||
2504|038|H|are part of a "step-up dosing schedule." The treatment schedule||
2504|039|H|is based on your medical condition and response to treatment.||
2504|040|H|Depending on your medical condition, you may be directed to stay||
2504|041|H|in the hospital for 24 hours or stay near the place of your||
2504|042|H|treatment (for example, within 2 hours' drive) so your doctor can||
2504|043|H|monitor you closely and help you manage any side effects after||
2504|044|H|the first full dose.||
2504|045|H|   Before you receive this medication, your doctor will prescribe||
2504|046|H|other medications (such as acetaminophen,||
2504|047|H|dexamethasone/prednisolone, diphenhydramine) to help prevent side||
2504|048|H|effects. Your doctor may also prescribe other medications (such||
2504|049|H|as antibiotics, antivirals) to help prevent infection. Carefully||
2504|050|H|follow your doctor's directions for all your medications.||
2504|051|H|   Use this medication regularly to get the most benefit from it.||
2504|052|H|To help you remember, mark your calendar with a reminder.||
2504|053|B|||
2504|054|S|SIDE EFFECTS:  See also Warning section.||
2504|055|S|   Tiredness, stomach pain, diarrhea, nausea, or muscle/joint||
2504|056|S|pain may occur. Pain, bruising, redness, itching, or swelling at||
2504|057|S|the injection site may also occur. If any of these effects last||
2504|058|S|or get worse, tell your doctor or pharmacist promptly.||
2504|059|S|   People using this medication may have serious side effects.||
2504|060|S|However, you have been prescribed this drug because your doctor||
2504|061|S|has judged that the benefit to you is greater than the risk of||
2504|062|S|side effects. Careful monitoring by your doctor may decrease your||
2504|063|S|risk.||
2504|064|S|   Tell your doctor right away if you have any serious side||
2504|065|S|effects, including: easy bruising/bleeding, signs of anemia (such||
2504|066|S|as unusual tiredness, pale skin).||
2504|067|S|   This medication may lower your ability to fight infections.||
2504|068|S|This may make you more likely to get a serious (rarely fatal)||
2504|069|S|infection or make any infection you have worse. Tell your doctor||
2504|070|S|right away if you have any signs of infection (such as sore||
2504|071|S|throat that doesn't go away, fever, chills).||
2504|072|S|   This medication may increase your risk of getting a rare but||
2504|073|S|very serious (possibly fatal) brain infection (progressive||
2504|074|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2504|075|S|if you have any of these new or worsening side effects:||
2504|076|S|clumsiness, loss of coordination/balance, weakness, sudden change||
2504|077|S|in your thinking (such as confusion, difficulty concentrating,||
2504|078|S|memory loss), difficulty talking/walking, seizure, vision||
2504|079|S|changes.||
2504|080|S|   A very serious allergic reaction to this drug is rare.||
2504|081|S|However, get medical help right away if you notice any symptoms||
2504|082|S|of a serious allergic reaction, including: rash, itching/swelling||
2504|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2504|084|S|breathing.||
2504|085|S|   This is not a complete list of possible side effects. If you||
2504|086|S|notice other effects not listed above, contact your doctor or||
2504|087|S|pharmacist.||
2504|088|S|   In the US -||
2504|089|S|   Call your doctor for medical advice about side effects. You||
2504|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2504|091|S|www.fda.gov/medwatch.||
2504|092|S|   In Canada - Call your doctor for medical advice about side||
2504|093|S|effects. You may report side effects to Health Canada at||
2504|094|S|1-866-234-2345.||
2504|095|B|||
2504|096|P|PRECAUTIONS:  Before using epcoritamab, tell your doctor or||
2504|097|P|pharmacist if you are allergic to it; or if you have any other||
2504|098|P|allergies. This product may contain inactive ingredients, which||
2504|099|P|can cause allergic reactions or other problems. Talk to your||
2504|100|P|pharmacist for more details.||
2504|101|P|   Before using this medication, tell your doctor or pharmacist||
2504|102|P|your medical history, especially of: current/recent infections.||
2504|103|P|   This drug may make you dizzy or drowsy or affect your thinking||
2504|104|P|and coordination. Alcohol or marijuana (cannabis) can worsen||
2504|105|P|these effects. Do not drive, use machinery, or do anything that||
2504|106|P|needs alertness until you can do it safely. Limit alcoholic||
2504|107|P|beverages. Talk to your doctor if you are using marijuana||
2504|108|P|(cannabis).||
2504|109|P|   This medication can make you more likely to get infections or||
2504|110|P|may make current infections worse. Stay away from anyone who has||
2504|111|P|an infection that may easily spread (such as chickenpox,||
2504|112|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2504|113|P|exposed to an infection or for more details.||
2504|114|P|   Tell your health care professional that you are using||
2504|115|P|epcoritamab before having any immunizations/vaccinations. Avoid||
2504|116|P|contact with people who have recently received live vaccines||
2504|117|P|(such as flu vaccine inhaled through the nose).||
2504|118|P|   Before having surgery, tell your doctor or dentist about all||
2504|119|P|the products you use (including prescription drugs,||
2504|120|P|nonprescription drugs, and herbal products).||
2504|121|P|   Tell your doctor if you are pregnant or plan to become||
2504|122|P|pregnant. You should not become pregnant while using epcoritamab.||
2504|123|P|Epcoritamab may harm an unborn baby. Your doctor should order a||
2504|124|P|pregnancy test before you start this medication. Ask about||
2504|125|P|reliable forms of birth control while using this medication and||
2504|126|P|for 4 months after the last dose. If you become pregnant, talk to||
2504|127|P|your doctor right away about the risks and benefits of this||
2504|128|P|medication.||
2504|129|P|   It is unknown if this drug passes into breast milk. Because of||
2504|130|P|the possible risk to the infant, breastfeeding is not recommended||
2504|131|P|while using this drug and for 4 months after the last dose.||
2504|132|P|Consult your doctor before breastfeeding.||
2504|133|B|||
2504|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2504|135|I|medications work or increase your risk for serious side effects.||
2504|136|I|This document does not contain all possible drug interactions.||
2504|137|I|Keep a list of all the products you use (including||
2504|138|I|prescription/nonprescription drugs and herbal products) and share||
2504|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
2504|140|I|the dosage of any medicines without your doctor's approval.||
2504|141|I|   Some products that may interact with this drug are: other||
2504|142|I|drugs that weaken the immune system/increase the risk of||
2504|143|I|infection (such as natalizumab, rituximab).||
2504|144|B|||
2504|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2504|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2504|147|O|poison control center right away. US residents can call||
2504|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2504|149|B|||
2504|150|N|NOTES:  Lab and/or medical tests (such as complete blood count)||
2504|151|N|should be done while you are using this medication. Keep all||
2504|152|N|medical and lab appointments. Consult your doctor for more||
2504|153|N|details.||
2504|154|B|||
2504|155|D|MISSED DOSE:  It is important to get each dose of this medication||
2504|156|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2504|157|D|right away for a new dosing schedule.||
2504|158|B|||
2504|159|R|STORAGE:  Not applicable. This medication is given in a hospital||
2504|160|R|or clinic and will not be stored at home.||
2504|161|B|||
2504|162|M|MEDICAL ALERT:  Your condition can cause complications in a||
2504|163|M|medical emergency. For information about enrolling in MedicAlert,||
2504|164|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2504|165|B|||
2504|166|A|Information last revised November 2025.||
2504|167|A|Copyright(c) 2025 First Databank, Inc.||
2504|168|B|||
2505|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2505|002|Z|does NOT have all possible information about this product. This||
2505|003|Z|information does not assure that this product is safe, effective,||
2505|004|Z|or appropriate for you. This information is not individual||
2505|005|Z|medical advice and does not substitute for the advice of your||
2505|006|Z|health care professional. Always ask your health care||
2505|007|Z|professional for complete information about this product and your||
2505|008|Z|specific health needs.||
2505|009|B|||
2505|010|T|SOTAGLIFLOZIN - ORAL||
2505|011|F|(SOE-ta-gli-FLOE-zin)||
2505|012|B|||
2505|013|C|COMMON BRAND NAME(S): Inpefa||
2505|014|B|||
2505|015|U|USES:  Sotagliflozin is used by people with heart failure or by||
2505|016|U|people with type 2 diabetes, kidney disease, and other heart||
2505|017|U|disease risk factors to lower the risk of death from heart||
2505|018|U|disease and to reduce the need to go to a doctor or hospital to||
2505|019|U|treat heart failure. Sotagliflozin works by increasing the||
2505|020|U|removal of sugar and sodium by your kidneys. This may help to||
2505|021|U|reduce the stress on the heart.||
2505|022|B|||
2505|023|H|HOW TO USE:  Read the Medication Guide provided by your||
2505|024|H|pharmacist before you start taking sotagliflozin and each time||
2505|025|H|you get a refill. If you have any questions, ask your doctor or||
2505|026|H|pharmacist.||
2505|027|H|   Take this medication by mouth as directed by your doctor,||
2505|028|H|usually once daily, within 1 hour before the first meal of the||
2505|029|H|day. The dosage is based on your medical condition and response||
2505|030|H|to treatment.||
2505|031|H|   The manufacturer directs not to crush or chew the tablet||
2505|032|H|before taking it. However, many similar drugs (immediate-release||
2505|033|H|tablets) can be crushed or chewed. Follow your doctor's||
2505|034|H|directions on how to take this medication.||
2505|035|H|   Use this medication regularly to get the most benefit from it.||
2505|036|H|To help you remember, take it at the same time each day.||
2505|037|B|||
2505|038|S|SIDE EFFECTS:  Diarrhea, dizziness, or lightheadedness may occur.||
2505|039|S|If any of these effects last or get worse, tell your doctor or||
2505|040|S|pharmacist promptly.||
2505|041|S|   To reduce the risk of dizziness and lightheadedness, get up||
2505|042|S|slowly when rising from a sitting or lying position.||
2505|043|S|   Remember that this medication has been prescribed because your||
2505|044|S|doctor has judged that the benefit to you is greater than the||
2505|045|S|risk of side effects. Many people using this medication do not||
2505|046|S|have serious side effects.||
2505|047|S|   Tell your doctor right away if you have any serious side||
2505|048|S|effects, including: signs of a urinary tract infection (such as||
2505|049|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
2505|050|S|signs of kidney problems (such as change in the amount of urine,||
2505|051|S|swelling legs/feet).||
2505|052|S|   Get medical help right away if you have any very serious side||
2505|053|S|effects, including: unusual tiredness, nausea/vomiting,||
2505|054|S|stomach/abdominal pain, trouble breathing.||
2505|055|S|   This medication may cause a new yeast infection in the vagina||
2505|056|S|or the penis. It may also cause a rare but very serious bacterial||
2505|057|S|infection in the genital/anal area (Fournier's gangrene). Tell||
2505|058|S|your doctor right away if you have signs of a yeast infection in||
2505|059|S|the vagina (such as unusual vaginal||
2505|060|S|discharge/burning/itching/odor) or in the penis (such as||
2505|061|S|redness/itching/swelling of the penis, unusual discharge from the||
2505|062|S|penis). However, get medical help right away if you have any||
2505|063|S|pain/redness/swelling in or around the genital/anal area, along||
2505|064|S|with a fever or feeling unwell.||
2505|065|S|   Sotagliflozin does not usually cause low blood sugar||
2505|066|S|(hypoglycemia). Low blood sugar may occur if this drug is||
2505|067|S|prescribed with other diabetes medications, or if you do not get||
2505|068|S|enough calories from food, or if you do unusually heavy exercise.||
2505|069|S|Talk with your doctor or pharmacist about whether the dose of||
2505|070|S|your other diabetes medication(s) needs to be lowered. Symptoms||
2505|071|S|of low blood sugar include sudden sweating, shaking, fast||
2505|072|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
2505|073|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
2505|074|S|treat low blood sugar. If you don't have these reliable forms of||
2505|075|S|glucose, rapidly raise your blood sugar by eating a quick source||
2505|076|S|of sugar such as table sugar, honey, or candy, or drink fruit||
2505|077|S|juice or non-diet soda. Tell your doctor right away about the||
2505|078|S|reaction and the use of this product. To help prevent low blood||
2505|079|S|sugar, eat meals on a regular schedule, and do not skip meals.||
2505|080|S|Check with your doctor or pharmacist to find out what you should||
2505|081|S|do if you miss a meal.||
2505|082|S|   This medication may cause you to become dehydrated. This can||
2505|083|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
2505|084|S|dehydration. Tell your doctor or pharmacist right away if you are||
2505|085|S|not able to drink fluids as usual, or losing fluid (such as due||
2505|086|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
2505|087|S|right away if you have any signs of dehydration, such as||
2505|088|S|urinating less than usual, unusual dry mouth/thirst, fast||
2505|089|S|heartbeat, or dizziness/lightheadedness/fainting.||
2505|090|S|   A very serious allergic reaction to this drug is rare.||
2505|091|S|However, get medical help right away if you notice any symptoms||
2505|092|S|of a serious allergic reaction, including: rash, itching/swelling||
2505|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2505|094|S|breathing.||
2505|095|S|   This is not a complete list of possible side effects. If you||
2505|096|S|notice other effects not listed above, contact your doctor or||
2505|097|S|pharmacist.||
2505|098|S|   In the US -||
2505|099|S|   Call your doctor for medical advice about side effects. You||
2505|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2505|101|S|www.fda.gov/medwatch.||
2505|102|S|   In Canada - Call your doctor for medical advice about side||
2505|103|S|effects. You may report side effects to Health Canada at||
2505|104|S|1-866-234-2345.||
2505|105|B|||
2505|106|P|PRECAUTIONS:  Before taking sotagliflozin, tell your doctor or||
2505|107|P|pharmacist if you are allergic to it; or if you have any other||
2505|108|P|allergies. This product may contain inactive ingredients, which||
2505|109|P|can cause allergic reactions or other problems. Talk to your||
2505|110|P|pharmacist for more details.||
2505|111|P|   Before using this medication, tell your doctor or pharmacist||
2505|112|P|your medical history, especially of: kidney disease, liver||
2505|113|P|disease, dehydration, use/abuse of alcohol, low blood pressure,||
2505|114|P|history of yeast infections in the vagina or penis, disease of||
2505|115|P|the pancreas.||
2505|116|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2505|117|P|can make you more dizzy. Do not drive, use machinery, or do||
2505|118|P|anything that needs alertness until you can do it safely. Limit||
2505|119|P|alcoholic beverages. Talk to your doctor if you are using||
2505|120|P|marijuana (cannabis).||
2505|121|P|   If you have diabetes, it may be harder to control your blood||
2505|122|P|sugar when your body is stressed (such as due to fever,||
2505|123|P|infection, injury, or surgery). Also, if you are eating less or||
2505|124|P|not able to eat due to these conditions or any illness, this can||
2505|125|P|lead to a high ketone level while you are taking this medication.||
2505|126|P|Consult your doctor because this may require a change in your||
2505|127|P|treatment plan, medications, or blood sugar or ketone testing.||
2505|128|P|   Before having surgery, tell your doctor or dentist about all||
2505|129|P|the products you use (including prescription drugs,||
2505|130|P|nonprescription drugs, and herbal products).||
2505|131|P|   Older adults may be more sensitive to the side effects of this||
2505|132|P|drug, especially dizziness/fainting (usually when standing),||
2505|133|P|dehydration, and kidney disease.||
2505|134|P|   During pregnancy, this medication should be used only when||
2505|135|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2505|136|P|benefits with your doctor.||
2505|137|P|   It is unknown if this drug passes into breast milk. Consult||
2505|138|P|your doctor before breastfeeding.||
2505|139|B|||
2505|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2505|141|I|medications work or increase your risk for serious side effects.||
2505|142|I|This document does not contain all possible drug interactions.||
2505|143|I|Keep a list of all the products you use (including||
2505|144|I|prescription/nonprescription drugs and herbal products) and share||
2505|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
2505|146|I|the dosage of any medicines without your doctor's approval.||
2505|147|I|   Other medications can affect the removal of sotagliflozin from||
2505|148|I|your body, which may affect how sotagliflozin works. An example||
2505|149|I|is rifampin, among others.||
2505|150|I|   Your urine will test positive for glucose. Make sure lab||
2505|151|I|personnel and all your doctors know you use this drug.||
2505|152|B|||
2505|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2505|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2505|155|O|poison control center right away. US residents can call||
2505|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2505|157|B|||
2505|158|N|NOTES:  Do not share this medication with others.||
2505|159|N|   Lab and/or medical tests (such as kidney function, blood||
2505|160|N|sugar, hemoglobin A1c, ketones) should be done before you start||
2505|161|N|taking this medication and while you are taking it. Keep all||
2505|162|N|medical and lab appointments. Consult your doctor for more||
2505|163|N|details.||
2505|164|B|||
2505|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2505|166|D|remember. If it is more than 6 hours after the missed dose, skip||
2505|167|D|the missed dose. Take your next dose at the regular time. Do not||
2505|168|D|double the dose to catch up.||
2505|169|B|||
2505|170|R|STORAGE:  Store at room temperature away from light and moisture.||
2505|171|R|Do not store in the bathroom. Keep all medications away from||
2505|172|R|children and pets.||
2505|173|R|   Do not flush medications down the toilet or pour them into a||
2505|174|R|drain unless instructed to do so. Properly discard this product||
2505|175|R|when it is expired or no longer needed. Consult your pharmacist||
2505|176|R|or local waste disposal company.||
2505|177|B|||
2505|178|M|MEDICAL ALERT:  Your condition can cause complications in a||
2505|179|M|medical emergency. For information about enrolling in MedicAlert,||
2505|180|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2505|181|B|||
2505|182|A|Information last revised May 2025.||
2505|183|A|Copyright(c) 2025 First Databank, Inc.||
2505|184|B|||
2506|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2506|002|Z|does NOT have all possible information about this product. This||
2506|003|Z|information does not assure that this product is safe, effective,||
2506|004|Z|or appropriate for you. This information is not individual||
2506|005|Z|medical advice and does not substitute for the advice of your||
2506|006|Z|health care professional. Always ask your health care||
2506|007|Z|professional for complete information about this product and your||
2506|008|Z|specific health needs.||
2506|009|B|||
2506|010|T|SODIUM PHENYLBUTYRATE PELLETS - ORAL||
2506|011|F|(SOE-dee-um FEN-il-BUE-ti-rate)||
2506|012|B|||
2506|013|C|COMMON BRAND NAME(S): Olpruva||
2506|014|B|||
2506|015|U|USES:  This medication is used along with diet changes for||
2506|016|U|long-term treatment of a certain inherited disorder (urea cycle||
2506|017|U|disorder). Sodium phenylbutyrate helps remove a certain chemical||
2506|018|U|(ammonia) from the body. Too much ammonia in the body can cause||
2506|019|U|brain damage and sometimes death.||
2506|020|U|   This medication should not be used to treat sudden, severely||
2506|021|U|high levels of ammonia in the body. Get medical help right away||
2506|022|U|if you have sudden symptoms of too much ammonia (such as trouble||
2506|023|U|thinking, nausea, vomiting, irritability, trouble speaking,||
2506|024|U|trouble walking, fainting).||
2506|025|B|||
2506|026|H|HOW TO USE:  Read the Patient Information Leaflet and||
2506|027|H|Instructions for Use provided by your pharmacist before you start||
2506|028|H|taking sodium phenylbutyrate and each time you get a refill.||
2506|029|H|Follow the illustrated directions for the proper use of this||
2506|030|H|medication. If you have any questions, ask your doctor or||
2506|031|H|pharmacist.||
2506|032|H|   Take this medication by mouth exactly as directed by your||
2506|033|H|doctor. The dosage is based on your weight or body size, medical||
2506|034|H|condition, and response to treatment. The total daily dose should||
2506|035|H|be divided into equal amounts and taken with each meal or feeding||
2506|036|H|(such as 3 to 6 times daily). Do not increase or decrease your||
2506|037|H|dose without your doctor's approval.||
2506|038|H|   This medication must be mixed as directed before taking. To||
2506|039|H|prepare a dose, pour the contents of the thickening packet into a||
2506|040|H|cup with 4 ounces/120 milliliters of water. Stir well for at||
2506|041|H|least 30 seconds until the water thickens. Then, open the||
2506|042|H|packet(s) containing sodium phenylbutyrate and pour its contents||
2506|043|H|into the cup with the thickened water mixture. Stir well for 15||
2506|044|H|seconds and drink all of the mixture within 5 minutes of mixing.||
2506|045|H|Add more water to the cup, stir, and drink all of the mixture to||
2506|046|H|make sure you are getting the entire dose. Discard mixture after||
2506|047|H|30 minutes. Do not prepare a supply in advance.||
2506|048|H|   If you are giving this medication through a feeding tube, ask||
2506|049|H|your health care professional which feeding tubes are safe to use||
2506|050|H|with sodium phenylbutyrate, and for detailed instructions on how||
2506|051|H|to properly mix and give it.||
2506|052|H|   Use this medication regularly to get the most benefit from it.||
2506|053|H|To help you remember, take it at the same times each day.||
2506|054|B|||
2506|055|S|SIDE EFFECTS:  Loss of appetite or menstrual changes||
2506|056|S|(delayed/irregular/absent periods) may occur. If either of these||
2506|057|S|effects lasts or gets worse, tell your doctor or pharmacist||
2506|058|S|promptly.||
2506|059|S|   Remember that this medication has been prescribed because your||
2506|060|S|doctor has judged that the benefit to you is greater than the||
2506|061|S|risk of side effects. Many people using this medication do not||
2506|062|S|have serious side effects.||
2506|063|S|   Tell your doctor right away if you have any serious side||
2506|064|S|effects, including: drowsiness/lightheadedness, fast/pounding||
2506|065|S|heartbeat, mental/mood changes (such as confusion), unusual||
2506|066|S|tiredness.||
2506|067|S|   A very serious allergic reaction to this drug is rare.||
2506|068|S|However, get medical help right away if you notice any symptoms||
2506|069|S|of a serious allergic reaction, including: rash, itching/swelling||
2506|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2506|071|S|breathing.||
2506|072|S|   This is not a complete list of possible side effects. If you||
2506|073|S|notice other effects not listed above, contact your doctor or||
2506|074|S|pharmacist.||
2506|075|S|   In the US -||
2506|076|S|   Call your doctor for medical advice about side effects. You||
2506|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2506|078|S|www.fda.gov/medwatch.||
2506|079|S|   In Canada - Call your doctor for medical advice about side||
2506|080|S|effects. You may report side effects to Health Canada at||
2506|081|S|1-866-234-2345.||
2506|082|B|||
2506|083|P|PRECAUTIONS:  Before taking sodium phenylbutyrate, tell your||
2506|084|P|doctor or pharmacist if you are allergic to it; or if you have||
2506|085|P|any other allergies. This product may contain inactive||
2506|086|P|ingredients, which can cause allergic reactions or other||
2506|087|P|problems. Talk to your pharmacist for more details.||
2506|088|P|   Before using this medication, tell your doctor or pharmacist||
2506|089|P|your medical history, especially of: a certain heart problem||
2506|090|P|(heart failure), kidney disease, liver disease, swelling (edema).||
2506|091|P|   This medication contains salt (sodium). Before taking this||
2506|092|P|medication, tell your doctor or pharmacist if you are on a||
2506|093|P|low-salt diet.||
2506|094|P|   Before having surgery, tell your doctor or dentist about all||
2506|095|P|the products you use (including prescription drugs,||
2506|096|P|nonprescription drugs, and herbal products).||
2506|097|P|   During pregnancy, this medication should be used only when||
2506|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
2506|099|P|   It is unknown if this medication passes into breast milk.||
2506|100|P|Consult your doctor before breastfeeding.||
2506|101|B|||
2506|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2506|103|I|medications work or increase your risk for serious side effects.||
2506|104|I|This document does not contain all possible drug interactions.||
2506|105|I|Keep a list of all the products you use (including||
2506|106|I|prescription/nonprescription drugs and herbal products) and share||
2506|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
2506|108|I|the dosage of any medicines without your doctor's approval.||
2506|109|B|||
2506|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2506|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2506|112|O|poison control center right away. US residents can call||
2506|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2506|114|B|||
2506|115|N|NOTES:  Do not share this medication with others.||
2506|116|N|   Lab and/or medical tests (such as plasma ammonia/amino acid||
2506|117|N|levels, complete blood count, blood potassium level, urine tests,||
2506|118|N|drug levels) should be done while you are taking this medication.||
2506|119|N|Keep all medical and lab appointments. Consult your doctor for||
2506|120|N|more details.||
2506|121|B|||
2506|122|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
2506|123|D|if it is on the same day. If you do not remember until the next||
2506|124|D|day, skip the missed dose. Take your next dose at the regular||
2506|125|D|time. Do not double the dose to catch up.||
2506|126|B|||
2506|127|R|STORAGE:  Store at room temperature away from light and moisture.||
2506|128|R|Do not store in the bathroom. Keep all medications away from||
2506|129|R|children and pets.||
2506|130|R|   Do not flush medications down the toilet or pour them into a||
2506|131|R|drain unless instructed to do so. Properly discard this product||
2506|132|R|when it is expired or no longer needed. Consult your pharmacist||
2506|133|R|or local waste disposal company.||
2506|134|B|||
2506|135|A|Information last revised October 2025.||
2506|136|A|Copyright(c) 2025 First Databank, Inc.||
2506|137|B|||
2507|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2507|002|Z|does NOT have all possible information about this product. This||
2507|003|Z|information does not assure that this product is safe, effective,||
2507|004|Z|or appropriate for you. This information is not individual||
2507|005|Z|medical advice and does not substitute for the advice of your||
2507|006|Z|health care professional. Always ask your health care||
2507|007|Z|professional for complete information about this product and your||
2507|008|Z|specific health needs.||
2507|009|B|||
2507|010|T|GIVOSIRAN - INJECTION||
2507|011|F|(GIV-oh-SIR-an)||
2507|012|B|||
2507|013|C|COMMON BRAND NAME(S): Givlaari||
2507|014|B|||
2507|015|U|USES:  Givosiran is used to treat a certain inherited disorder||
2507|016|U|(acute hepatic porphyria). This disorder causes a buildup of||
2507|017|U|certain chemicals (porphyrins) in the body which can lead to||
2507|018|U|liver and nerve problems. Givosiran works by reducing the amount||
2507|019|U|of porphyrins in the body.||
2507|020|B|||
2507|021|H|HOW TO USE:  This medication is given by injection under the skin||
2507|022|H|by a health care professional. It is given as directed by your||
2507|023|H|doctor, usually once a month.||
2507|024|H|   The dosage is based on your medical condition, weight, and||
2507|025|H|response to treatment.||
2507|026|H|   Use this medication regularly to get the most benefit from it.||
2507|027|H|To help you remember, mark your calendar with a reminder.||
2507|028|H|   Tell your doctor if your condition gets worse.||
2507|029|B|||
2507|030|S|SIDE EFFECTS:  Pain, redness, itching, or swelling of the skin at||
2507|031|S|the injection site may occur. Nausea or tiredness may also occur.||
2507|032|S|If any of these effects last or get worse, tell your doctor or||
2507|033|S|pharmacist promptly.||
2507|034|S|   Remember that this medication has been prescribed because your||
2507|035|S|doctor has judged that the benefit to you is greater than the||
2507|036|S|risk of side effects. Many people using this medication do not||
2507|037|S|have serious side effects.||
2507|038|S|   Tell your doctor right away if you have any serious side||
2507|039|S|effects, including: signs of liver disease (such as||
2507|040|S|nausea/vomiting that doesn't stop, loss of appetite,||
2507|041|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2507|042|S|of kidney problems (such as change in the amount of urine).||
2507|043|S|   A very serious allergic reaction to this drug is rare.||
2507|044|S|However, get medical help right away if you notice any symptoms||
2507|045|S|of a serious allergic reaction, including: rash, itching/swelling||
2507|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2507|047|S|breathing.||
2507|048|S|   This is not a complete list of possible side effects. If you||
2507|049|S|notice other effects not listed above, contact your doctor or||
2507|050|S|pharmacist.||
2507|051|S|   In the US -||
2507|052|S|   Call your doctor for medical advice about side effects. You||
2507|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2507|054|S|www.fda.gov/medwatch.||
2507|055|S|   In Canada - Call your doctor for medical advice about side||
2507|056|S|effects. You may report side effects to Health Canada at||
2507|057|S|1-866-234-2345.||
2507|058|B|||
2507|059|P|PRECAUTIONS:  Before using givosiran, tell your doctor or||
2507|060|P|pharmacist if you are allergic to it; or if you have any other||
2507|061|P|allergies. This product may contain inactive ingredients, which||
2507|062|P|can cause allergic reactions or other problems. Talk to your||
2507|063|P|pharmacist for more details.||
2507|064|P|   Before using this medication, tell your doctor or pharmacist||
2507|065|P|your medical history, especially of: kidney disease, liver||
2507|066|P|disease.||
2507|067|P|   Before having surgery, tell your doctor or dentist about all||
2507|068|P|the products you use (including prescription drugs,||
2507|069|P|nonprescription drugs, and herbal products).||
2507|070|P|   During pregnancy, this medication should be used only when||
2507|071|P|clearly needed. Discuss the risks and benefits with your doctor.||
2507|072|P|   It is unknown if this medication passes into breast milk.||
2507|073|P|Consult your doctor before breastfeeding.||
2507|074|B|||
2507|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2507|076|I|medications work or increase your risk for serious side effects.||
2507|077|I|This document does not contain all possible drug interactions.||
2507|078|I|Keep a list of all the products you use (including||
2507|079|I|prescription/nonprescription drugs and herbal products) and share||
2507|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
2507|081|I|the dosage of any medicines without your doctor's approval.||
2507|082|B|||
2507|083|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2507|084|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2507|085|O|poison control center right away. US residents can call||
2507|086|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2507|087|B|||
2507|088|N|NOTES:  Lab and/or medical tests (such as liver/kidney function,||
2507|089|N|homocysteine blood level, amylase/lipase level) should be done||
2507|090|N|before you start using this medication and while you are using||
2507|091|N|it. Keep all medical and lab appointments. Consult your doctor||
2507|092|N|for more details.||
2507|093|B|||
2507|094|D|MISSED DOSE:  It is important to get each dose of this medication||
2507|095|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2507|096|D|right away for a new dosing schedule.||
2507|097|B|||
2507|098|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2507|099|R|doctor's office and will not be stored at home.||
2507|100|B|||
2507|101|A|Information last revised October 2024.||
2507|102|A|Copyright(c) 2025 First Databank, Inc.||
2507|103|B|||
2508|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2508|002|Z|does NOT have all possible information about this product. This||
2508|003|Z|information does not assure that this product is safe, effective,||
2508|004|Z|or appropriate for you. This information is not individual||
2508|005|Z|medical advice and does not substitute for the advice of your||
2508|006|Z|health care professional. Always ask your health care||
2508|007|Z|professional for complete information about this product and your||
2508|008|Z|specific health needs.||
2508|009|B|||
2508|010|T|ONASEMNOGENE ABEPARVOVEC - INJECTION||
2508|011|F|(ON-a-SEM-noe-jeen A-be-PAR-voe-vek)||
2508|012|B|||
2508|013|C|COMMON BRAND NAME(S): Zolgensma||
2508|014|B|||
2508|015|W|WARNING:  Onasemnogene abeparvovec may rarely cause very serious||
2508|016|W|(possibly fatal) liver disease. Before treatment with this||
2508|017|W|medication, tell the doctor if your child has liver disease. The||
2508|018|W|doctor should do lab tests to monitor your child's liver function||
2508|019|W|before and after your child receives treatment. To decrease the||
2508|020|W|risk of liver problems, the doctor may also direct your child to||
2508|021|W|take another medication by mouth (a corticosteroid such as||
2508|022|W|prednisolone) before and after your child receives onasemnogene||
2508|023|W|abeparvovec. Get medical help right away if your child develops||
2508|024|W|symptoms of liver disease, such as nausea/vomiting that doesn't||
2508|025|W|stop, loss of appetite, stomach/abdominal pain, yellowing||
2508|026|W|eyes/skin, or dark urine.||
2508|027|B|||
2508|028|U|USES:  This medication is used to treat a certain nervous system||
2508|029|U|disorder that can lead to muscle weakness and muscle loss (spinal||
2508|030|U|muscular atrophy). Onasemnogene abeparvovec is made from a||
2508|031|U|certain virus that has been specially prepared. The virus is used||
2508|032|U|to carry a certain human gene into cells. This type of treatment||
2508|033|U|is known as gene therapy. Treatment may improve motor function.||
2508|034|B|||
2508|035|H|HOW TO USE:  This medication is given by slow injection into a||
2508|036|H|vein as directed by the doctor. It is given as a single dose. The||
2508|037|H|dosage is based on your child's body weight.||
2508|038|H|   Small amounts of virus may shed from the child's stool for up||
2508|039|H|to 1 month after the injection. Ask the doctor how to handle and||
2508|040|H|dispose of waste materials (such as diapers) for up to 1 month||
2508|041|H|after the injection.||
2508|042|B|||
2508|043|S|SIDE EFFECTS:  See also Warning section.||
2508|044|S|   Vomiting may occur. If this effect lasts or gets worse, tell||
2508|045|S|the doctor or pharmacist promptly.||
2508|046|S|   Remember that this medication has been prescribed because the||
2508|047|S|doctor has judged that the benefit to your child is greater than||
2508|048|S|the risk of side effects. Many people using this medication do||
2508|049|S|not have serious side effects.||
2508|050|S|   Tell the doctor right away if your child has any serious side||
2508|051|S|effects, including: easy bleeding/bruising, signs of kidney||
2508|052|S|problems (such as change in the amount of urine).||
2508|053|S|   Get medical help right away if your child has any very serious||
2508|054|S|side effects, including: seizures.||
2508|055|S|   A very serious allergic reaction to this drug is rare.||
2508|056|S|However, get medical help right away if you notice any symptoms||
2508|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2508|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2508|059|S|breathing.||
2508|060|S|   This is not a complete list of possible side effects. If you||
2508|061|S|notice other effects not listed above, contact your doctor or||
2508|062|S|pharmacist.||
2508|063|S|   In the US -||
2508|064|S|   Call your doctor for medical advice about side effects. You||
2508|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2508|066|S|www.fda.gov/medwatch.||
2508|067|S|   In Canada - Call your doctor for medical advice about side||
2508|068|S|effects. You may report side effects to Health Canada at||
2508|069|S|1-866-234-2345.||
2508|070|B|||
2508|071|P|PRECAUTIONS:  Before this medication is given, tell the doctor or||
2508|072|P|pharmacist if your child has any allergies. This product may||
2508|073|P|contain inactive ingredients, which can cause allergic reactions||
2508|074|P|or other problems. Talk to the pharmacist for more details.||
2508|075|P|   Before using this medication, tell the doctor or pharmacist||
2508|076|P|your child's medical history, especially of: liver problems||
2508|077|P|(including cirrhosis, fatty liver disease, hepatitis B or C),||
2508|078|P|current/recent infection.||
2508|079|P|   Onasemnogene abeparvovec may make current infections worse.||
2508|080|P|Stay away from anyone who has an infection that may easily spread||
2508|081|P|(such as chickenpox, COVID-19, measles, flu). Talk to the doctor||
2508|082|P|if your child has been exposed to an infection or for more||
2508|083|P|details.||
2508|084|P|   Tell the health care professional that your child has received||
2508|085|P|this medication before having any immunizations/vaccinations.||
2508|086|P|Avoid contact with people who have recently received live||
2508|087|P|vaccines (such as flu vaccine inhaled through the nose).||
2508|088|P|   Before having surgery, tell the doctor or dentist about all||
2508|089|P|the products your child uses (including prescription drugs,||
2508|090|P|nonprescription drugs, and herbal products).||
2508|091|P|   This medication is not usually used by adults. It is unlikely||
2508|092|P|to be used during pregnancy or breastfeeding. Consult your doctor||
2508|093|P|if you have any questions about this medication.||
2508|094|B|||
2508|095|I|DRUG INTERACTIONS:  Drug interactions may change how your child's||
2508|096|I|medications work or increase the risk for serious side effects.||
2508|097|I|This document does not contain all possible drug interactions.||
2508|098|I|Keep a list of all the products you use (including||
2508|099|I|prescription/nonprescription drugs and herbal products) and share||
2508|100|I|it with the doctor and pharmacist. Do not start, stop, or change||
2508|101|I|the dosage of any medicines without the doctor's approval.||
2508|102|B|||
2508|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2508|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2508|105|O|poison control center right away. US residents can call||
2508|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2508|107|B|||
2508|108|N|NOTES:  Lab and/or medical tests (such as liver function,||
2508|109|N|complete blood count) must be done before your child starts||
2508|110|N|receiving this medication and after your child receives it. Keep||
2508|111|N|all medical and lab appointments.||
2508|112|N|   After receiving this treatment, your child cannot donate||
2508|113|N|blood, organs, tissues, or cells.||
2508|114|B|||
2508|115|D|MISSED DOSE:  Not applicable.||
2508|116|B|||
2508|117|R|STORAGE:  Not applicable. This type of product is given in a||
2508|118|R|hospital or clinic and will not be stored at home.||
2508|119|B|||
2508|120|M|MEDICAL ALERT:  Your condition can cause complications in a||
2508|121|M|medical emergency. For information about enrolling in MedicAlert,||
2508|122|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2508|123|B|||
2508|124|A|Information last revised May 2024.||
2508|125|A|Copyright(c) 2025 First Databank, Inc.||
2508|126|B|||
2509|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2509|002|Z|does NOT have all possible information about this product. This||
2509|003|Z|information does not assure that this product is safe, effective,||
2509|004|Z|or appropriate for you. This information is not individual||
2509|005|Z|medical advice and does not substitute for the advice of your||
2509|006|Z|health care professional. Always ask your health care||
2509|007|Z|professional for complete information about this product and your||
2509|008|Z|specific health needs.||
2509|009|B|||
2509|010|T|PERFLUOROHEXYLOCTANE - OPHTHALMIC||
2509|011|B|||
2509|012|C|COMMON BRAND NAME(S): Miebo||
2509|013|B|||
2509|014|U|USES:  This medication is used to relieve dry, irritated eyes.||
2509|015|U|Perfluorohexyloctane works by keeping your tears from drying up.||
2509|016|U|This keeps the eye moist, helps protect the eye from injury and||
2509|017|U|infection, and decreases symptoms of dry eyes such as burning,||
2509|018|U|itching, and feeling as if something is in the eye.||
2509|019|B|||
2509|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
2509|021|H|directed by your doctor, usually 4 times a day.||
2509|022|H|   To apply eye drops, wash hands first. To avoid contamination,||
2509|023|H|do not touch the dropper tip or let it touch your eye or any||
2509|024|H|other surface.||
2509|025|H|   If you are wearing contact lenses, remove them before using||
2509|026|H|eye drops. Wait at least 30 minutes before replacing your contact||
2509|027|H|lenses. Tilt your head back, look upward, and pull down the lower||
2509|028|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2509|029|H|and place one drop into the pouch. Look downward, gently close||
2509|030|H|your eyes, and place one finger at the corner of your eye (near||
2509|031|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2509|032|H|opening your eyes. This will prevent the medication from draining||
2509|033|H|out. Try not to blink or rub your eye. If directed to use this||
2509|034|H|medication in both eyes, repeat these steps for your other eye.||
2509|035|H|Do not rinse the dropper. Replace the dropper cap after each use.||
2509|036|H|   Wait several minutes for your vision to clear before driving||
2509|037|H|or operating machinery.||
2509|038|H|   Use this medication regularly to get the most benefit from it.||
2509|039|H|To help you remember, use it at the same times each day.||
2509|040|H|   Tell your doctor if your condition lasts or gets worse.||
2509|041|B|||
2509|042|S|SIDE EFFECTS:  Eye redness or temporary blurred vision may occur.||
2509|043|S|If either of these effects lasts or gets worse, tell your doctor||
2509|044|S|or pharmacist promptly.||
2509|045|S|   Remember that this medication has been prescribed because your||
2509|046|S|doctor has judged that the benefit to you is greater than the||
2509|047|S|risk of side effects. Many people using this medication do not||
2509|048|S|have serious side effects.||
2509|049|S|   A very serious allergic reaction to this drug is rare.||
2509|050|S|However, get medical help right away if you notice any symptoms||
2509|051|S|of a serious allergic reaction, including: rash, itching/swelling||
2509|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2509|053|S|breathing.||
2509|054|S|   This is not a complete list of possible side effects. If you||
2509|055|S|notice other effects not listed above, contact your doctor or||
2509|056|S|pharmacist.||
2509|057|S|   In the US -||
2509|058|S|   Call your doctor for medical advice about side effects. You||
2509|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2509|060|S|www.fda.gov/medwatch.||
2509|061|S|   In Canada - Call your doctor for medical advice about side||
2509|062|S|effects. You may report side effects to Health Canada at||
2509|063|S|1-866-234-2345.||
2509|064|B|||
2509|065|P|PRECAUTIONS:  Before using perfluorohexyloctane, tell your doctor||
2509|066|P|or pharmacist if you are allergic to it; or if you have any other||
2509|067|P|allergies. This product may contain inactive ingredients, which||
2509|068|P|can cause allergic reactions or other problems. Talk to your||
2509|069|P|pharmacist for more details.||
2509|070|P|   Before using this medication, tell your doctor or pharmacist||
2509|071|P|your medical history.||
2509|072|P|   After you apply this drug, your vision may become temporarily||
2509|073|P|blurred. Do not drive, use machinery, or do anything that needs||
2509|074|P|clear vision until you can do it safely.||
2509|075|P|   Before having surgery, tell your doctor or dentist about all||
2509|076|P|the products you use (including prescription drugs,||
2509|077|P|nonprescription drugs, and herbal products).||
2509|078|P|   During pregnancy, this medication should be used only when||
2509|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
2509|080|P|   It is unknown if this drug passes into breast milk. Consult||
2509|081|P|your doctor before breastfeeding.||
2509|082|B|||
2509|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2509|084|I|medications work or increase your risk for serious side effects.||
2509|085|I|This document does not contain all possible drug interactions.||
2509|086|I|Keep a list of all the products you use (including||
2509|087|I|prescription/nonprescription drugs and herbal products) and share||
2509|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
2509|089|I|the dosage of any medicines without your doctor's approval.||
2509|090|B|||
2509|091|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2509|092|O|has overdosed and has serious symptoms such as passing out or||
2509|093|O|trouble breathing, call 911. Otherwise, call a poison control||
2509|094|O|center right away. US residents can call 1-800-222-1222. Canada||
2509|095|O|residents can call 1-844-764-7669.||
2509|096|B|||
2509|097|N|NOTES:  Do not share this medication with others.||
2509|098|B|||
2509|099|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2509|100|D|If it is near the time of the next dose, skip the missed dose.||
2509|101|D|Use your next dose at the regular time. Do not double the dose to||
2509|102|D|catch up.||
2509|103|B|||
2509|104|R|STORAGE:  Store at room temperature. Keep all medications away||
2509|105|R|from children and pets.||
2509|106|R|   Do not flush medications down the toilet or pour them into a||
2509|107|R|drain unless instructed to do so. Properly discard this product||
2509|108|R|when it is expired or no longer needed. Consult your pharmacist||
2509|109|R|or local waste disposal company.||
2509|110|B|||
2509|111|A|Information last revised July 2025.||
2509|112|A|Copyright(c) 2025 First Databank, Inc.||
2509|113|B|||
2510|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2510|002|Z|does NOT have all possible information about this product. This||
2510|003|Z|information does not assure that this product is safe, effective,||
2510|004|Z|or appropriate for you. This information is not individual||
2510|005|Z|medical advice and does not substitute for the advice of your||
2510|006|Z|health care professional. Always ask your health care||
2510|007|Z|professional for complete information about this product and your||
2510|008|Z|specific health needs.||
2510|009|B|||
2510|010|T|EFGARTIGIMOD ALFA/HYALURONIDASE - SUBCUTANEOUS INJECTION||
2510|011|F|(EF-gar-TIG-i-mod AL-fa/HYE-al-ure-ON-i-dase)||
2510|012|B|||
2510|013|C|COMMON BRAND NAME(S): Vyvgart Hytrulo||
2510|014|B|||
2510|015|U|USES:  Efgartigimod alfa is used to treat a certain muscle||
2510|016|U|condition (generalized myasthenia gravis). It may help to improve||
2510|017|U|symptoms of muscle weakness.||
2510|018|U|   This medication is also used to treat a certain nerve disorder||
2510|019|U|(chronic inflammatory demyelinating polyneuropathy-CIDP).||
2510|020|U|Efgartigimod alfa may help slow down the worsening of weakness in||
2510|021|U|the arms and legs.||
2510|022|U|   Hyaluronidase is used to help the body absorb efgartigimod||
2510|023|U|alfa, which helps it work better.||
2510|024|B|||
2510|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
2510|026|H|Instructions for Use if available from your pharmacist before you||
2510|027|H|start using this medication and each time you get a refill. If||
2510|028|H|you have any questions, ask your doctor or pharmacist.||
2510|029|H|   If you are using this medication at home, learn all||
2510|030|H|preparation and usage instructions from your health care||
2510|031|H|professional and the product package.||
2510|032|H|   Inject this medication under the skin as directed by your||
2510|033|H|doctor, usually once weekly. The injection is given in the||
2510|034|H|abdomen (except for a 2-inch area around your belly button).||
2510|035|H|Additional treatment cycles are given based on your medical||
2510|036|H|condition and response to treatment.||
2510|037|H|   Take the medication out of the refrigerator at least 30||
2510|038|H|minutes before you inject it to allow it to reach room||
2510|039|H|temperature. Do not warm up this medication any other way (for||
2510|040|H|example, do not heat it in the microwave, place it in hot water,||
2510|041|H|or leave it in direct sunlight). Do not shake the medication.||
2510|042|H|Before using, check this product for particles or discoloration.||
2510|043|H|If either is present, do not use the liquid. Before injecting||
2510|044|H|each dose, clean the skin you are going to inject into (the||
2510|045|H|injection site) with rubbing alcohol. Change the injection site||
2510|046|H|each time to lessen injury under the skin. Do not inject into||
2510|047|H|skin that is tender, bruised, red, hard, or damaged. To lessen||
2510|048|H|bruising, do not rub the injection site after a shot. Learn how||
2510|049|H|to store and discard medical supplies safely.||
2510|050|H|   Injection reactions or serious allergic reactions may happen||
2510|051|H|during the injection and for a short time afterward. Tell your||
2510|052|H|doctor right away if you have any symptoms of injection reactions||
2510|053|H|such as high blood pressure, chills, shivering, stomach pain, or||
2510|054|H|back/chest pain. Your doctor may give you other medications to||
2510|055|H|help with these side effects or may slow down your injection.||
2510|056|H|Monitor for an allergic reaction for at least 30 minutes after||
2510|057|H|each injection and get medical help right away if you notice any||
2510|058|H|symptoms of a serious allergic reaction (see also Side Effects||
2510|059|H|section).||
2510|060|H|   Use this medication regularly to get the most benefit from it.||
2510|061|H|To help you remember, mark your calendar with a reminder.||
2510|062|H|   Tell your doctor if your condition gets worse.||
2510|063|B|||
2510|064|S|SIDE EFFECTS:  See also How to Use section.||
2510|065|S|   Headache or injection site reactions (such as redness, pain,||
2510|066|S|bruising, itching, swelling) may occur. If any of these effects||
2510|067|S|last or get worse, tell your doctor or pharmacist promptly.||
2510|068|S|   Remember that this medication has been prescribed because your||
2510|069|S|doctor has judged that the benefit to you is greater than the||
2510|070|S|risk of side effects. Many people using this medication do not||
2510|071|S|have serious side effects.||
2510|072|S|   This medication may lower your ability to fight infections.||
2510|073|S|This may make you more likely to get a serious infection or make||
2510|074|S|any infection you have worse. Tell your doctor right away if you||
2510|075|S|have any signs of infection (such as sore throat that doesn't go||
2510|076|S|away, fever, chills, painful/burning urination).||
2510|077|S|   A very serious allergic reaction to this drug is rare.||
2510|078|S|However, get medical help right away if you notice any symptoms||
2510|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2510|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2510|081|S|breathing.||
2510|082|S|   This is not a complete list of possible side effects. If you||
2510|083|S|notice other effects not listed above, contact your doctor or||
2510|084|S|pharmacist.||
2510|085|S|   In the US -||
2510|086|S|   Call your doctor for medical advice about side effects. You||
2510|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2510|088|S|www.fda.gov/medwatch.||
2510|089|S|   In Canada - Call your doctor for medical advice about side||
2510|090|S|effects. You may report side effects to Health Canada at||
2510|091|S|1-866-234-2345.||
2510|092|B|||
2510|093|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2510|094|P|pharmacist if you are allergic to efgartigimod alfa or||
2510|095|P|hyaluronidase; or if you have any other allergies. This product||
2510|096|P|may contain inactive ingredients, which can cause allergic||
2510|097|P|reactions or other problems. Talk to your pharmacist for more||
2510|098|P|details.||
2510|099|P|   Before using this medication, tell your doctor or pharmacist||
2510|100|P|your medical history, especially of: current/recent infection.||
2510|101|P|   Efgartigimod alfa can make you more likely to get infections||
2510|102|P|or may make current infections worse. Stay away from anyone who||
2510|103|P|has an infection that may easily spread (such as chickenpox,||
2510|104|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2510|105|P|exposed to an infection or for more details.||
2510|106|P|   Tell your health care professional that you are using this||
2510|107|P|product before having any immunizations/vaccinations. Avoid||
2510|108|P|contact with people who have recently received live vaccines||
2510|109|P|(such as flu vaccine inhaled through the nose).||
2510|110|P|   Before having surgery, tell your doctor or dentist about all||
2510|111|P|the products you use (including prescription drugs,||
2510|112|P|nonprescription drugs, and herbal products).||
2510|113|P|   During pregnancy, this medication should be used only when||
2510|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
2510|115|P|Mothers who have used this medication during pregnancy should ask||
2510|116|P|a doctor about immunizations/vaccinations for their newborn||
2510|117|P|babies.||
2510|118|P|   It is unknown if this drug passes into breast milk. Consult||
2510|119|P|your doctor before breastfeeding.||
2510|120|B|||
2510|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2510|122|I|medications work or increase your risk for serious side effects.||
2510|123|I|This document does not contain all possible drug interactions.||
2510|124|I|Keep a list of all the products you use (including||
2510|125|I|prescription/nonprescription drugs and herbal products) and share||
2510|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
2510|127|I|the dosage of any medicines without your doctor's approval.||
2510|128|B|||
2510|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2510|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2510|131|O|poison control center right away. US residents can call||
2510|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2510|133|B|||
2510|134|N|NOTES:  Lab and/or medical tests (such as complete blood count)||
2510|135|N|should be done while you are using this medication. Keep all||
2510|136|N|medical and lab appointments. Consult your doctor for more||
2510|137|N|details.||
2510|138|B|||
2510|139|D|MISSED DOSE:  It is important to get each dose of this medication||
2510|140|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2510|141|D|right away for a new dosing schedule.||
2510|142|B|||
2510|143|R|STORAGE:  Store in the refrigerator. Do not freeze. Do not use||
2510|144|R|this medication if it has been frozen. Keep the medication in the||
2510|145|R|original carton to protect from light. This medication may also||
2510|146|R|be stored at room temperature if needed. If the medication is||
2510|147|R|stored at room temperature, do not put it back in the||
2510|148|R|refrigerator and discard after 30 days. Keep all medications away||
2510|149|R|from children and pets.||
2510|150|R|   Do not flush medications down the toilet or pour them into a||
2510|151|R|drain unless instructed to do so. Properly discard this product||
2510|152|R|when it is expired or no longer needed. Consult your pharmacist||
2510|153|R|or local waste disposal company.||
2510|154|B|||
2510|155|M|MEDICAL ALERT:  Your condition can cause complications in a||
2510|156|M|medical emergency. For information about enrolling in MedicAlert,||
2510|157|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2510|158|B|||
2510|159|A|Information last revised April 2025.||
2510|160|A|Copyright(c) 2025 First Databank, Inc.||
2510|161|B|||
2511|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2511|002|Z|does NOT have all possible information about this product. This||
2511|003|Z|information does not assure that this product is safe, effective,||
2511|004|Z|or appropriate for you. This information is not individual||
2511|005|Z|medical advice and does not substitute for the advice of your||
2511|006|Z|health care professional. Always ask your health care||
2511|007|Z|professional for complete information about this product and your||
2511|008|Z|specific health needs.||
2511|009|B|||
2511|010|T|DELANDISTROGENE MOXEPARVOVEC - INJECTION||
2511|011|B|||
2511|012|C|COMMON BRAND NAME(S): Elevidys||
2511|013|B|||
2511|014|W|WARNING:  Delandistrogene moxeparvovec may rarely cause very||
2511|015|W|serious (possibly fatal) liver disease. Before treatment with||
2511|016|W|this medication, tell the doctor if your child has liver disease.||
2511|017|W|The doctor should do lab tests to monitor your child's liver||
2511|018|W|function before and after your child receives treatment. To||
2511|019|W|decrease the risk of liver problems, the doctor may also direct||
2511|020|W|your child to take another medication by mouth (a corticosteroid||
2511|021|W|such as prednisone) before and after your child receives this||
2511|022|W|medication. Get medical help right away if your child develops||
2511|023|W|symptoms of liver disease, such as nausea/vomiting that doesn't||
2511|024|W|stop, loss of appetite, stomach/abdominal pain, yellowing||
2511|025|W|eyes/skin, dark urine.||
2511|026|B|||
2511|027|U|USES:  This medication is used to treat a certain muscle disorder||
2511|028|U|that can lead to muscle weakness (Duchenne muscular dystrophy).||
2511|029|U|Delandistrogene moxeparvovec is made from a certain virus that||
2511|030|U|has been specially prepared. The virus is used to carry a certain||
2511|031|U|human gene into cells. This type of treatment is known as gene||
2511|032|U|therapy.||
2511|033|B|||
2511|034|H|HOW TO USE:  Read the Medication Guide from your pharmacist||
2511|035|H|before you receive this product. If you have any questions, ask||
2511|036|H|your doctor or pharmacist.||
2511|037|H|   This medication is given by slow injection into a vein as||
2511|038|H|directed by the doctor. It is given as a single dose. The dosage||
2511|039|H|is based on your child's body weight. You should plan to stay||
2511|040|H|near the place of your child's treatment for at least 2 months||
2511|041|H|after the treatment (for example, within 2 hours' drive). Your||
2511|042|H|child's doctor will help you manage any side effects.||
2511|043|H|   Infusion reactions may happen during the infusion of this drug||
2511|044|H|and for up to several hours afterward. Tell the doctor right away||
2511|045|H|if your child has any symptoms of infusion reactions such as fast||
2511|046|H|heartbeat, fast breathing, flushing, nausea, vomiting, fever, or||
2511|047|H|chills. The doctor may give your child other medications to help||
2511|048|H|with these side effects or may slow down or stop the treatment||
2511|049|H|for some time.||
2511|050|H|   Small amounts of virus may shed from the child's stool/urine||
2511|051|H|for up to 1 month after the injection. Ask the doctor how to||
2511|052|H|handle and dispose of waste materials (such as diapers) for up to||
2511|053|H|1 month after the injection.||
2511|054|B|||
2511|055|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2511|056|S|   Remember that this medication has been prescribed because the||
2511|057|S|doctor has judged that the benefit to your child is greater than||
2511|058|S|the risk of side effects. Many people using this medication do||
2511|059|S|not have serious side effects.||
2511|060|S|   Tell the doctor right away if your child has any serious side||
2511|061|S|effects, including: easy bleeding/bruising, unexplained muscle||
2511|062|S|aches/weakness, difficulty swallowing/speaking.||
2511|063|S|   Get medical help right away if your child has any very serious||
2511|064|S|side effects, including: chest pain, shortness of breath.||
2511|065|S|   A very serious allergic reaction to this drug is rare.||
2511|066|S|However, get medical help right away if you notice any symptoms||
2511|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2511|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2511|069|S|breathing.||
2511|070|S|   This is not a complete list of possible side effects. If you||
2511|071|S|notice other effects not listed above, contact your doctor or||
2511|072|S|pharmacist.||
2511|073|S|   In the US -||
2511|074|S|   Call your doctor for medical advice about side effects. You||
2511|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2511|076|S|www.fda.gov/medwatch.||
2511|077|S|   In Canada - Call your doctor for medical advice about side||
2511|078|S|effects. You may report side effects to Health Canada at||
2511|079|S|1-866-234-2345.||
2511|080|B|||
2511|081|P|PRECAUTIONS:  Before this medication is given, tell the doctor or||
2511|082|P|pharmacist if your child has any allergies. This product may||
2511|083|P|contain inactive ingredients, which can cause allergic reactions||
2511|084|P|or other problems. Talk to the pharmacist for more details.||
2511|085|P|   Before using this medication, tell the doctor or pharmacist||
2511|086|P|your child's medical history, especially of: liver problems||
2511|087|P|(including cirrhosis, fatty liver disease, hepatitis B or C),||
2511|088|P|current/recent infection, heart problems.||
2511|089|P|   Delandistrogene moxeparvovec may make current infections||
2511|090|P|worse. Stay away from anyone who has an infection that may easily||
2511|091|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to the||
2511|092|P|doctor if your child has been exposed to an infection or for more||
2511|093|P|details.||
2511|094|P|   Tell the health care professional that your child has received||
2511|095|P|this medication before having any immunizations/vaccinations.||
2511|096|P|Avoid contact with people who have recently received live||
2511|097|P|vaccines (such as flu vaccine inhaled through the nose).||
2511|098|P|   Before having surgery, tell the doctor or dentist about all||
2511|099|P|the products your child uses (including prescription drugs,||
2511|100|P|nonprescription drugs, and herbal products).||
2511|101|P|   This medication is not usually used by women. It is unlikely||
2511|102|P|to be used during pregnancy or breastfeeding. Consult your doctor||
2511|103|P|if you have any questions about this medication.||
2511|104|B|||
2511|105|I|DRUG INTERACTIONS:  Drug interactions may change how your child's||
2511|106|I|medications work or increase the risk for serious side effects.||
2511|107|I|This document does not contain all possible drug interactions.||
2511|108|I|Keep a list of all the products you use (including||
2511|109|I|prescription/nonprescription drugs and herbal products) and share||
2511|110|I|it with the doctor and pharmacist. Do not start, stop, or change||
2511|111|I|the dosage of any medicines without the doctor's approval.||
2511|112|B|||
2511|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2511|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2511|115|O|poison control center right away. US residents can call||
2511|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2511|117|B|||
2511|118|N|NOTES:  Lab and/or medical tests (such as liver function,||
2511|119|N|complete blood count, troponin levels) must be done before your||
2511|120|N|child starts receiving this medication and after your child||
2511|121|N|receives it. Keep all medical and lab appointments.||
2511|122|N|   After receiving this treatment, your child cannot donate||
2511|123|N|blood, organs, tissues, or cells.||
2511|124|B|||
2511|125|D|MISSED DOSE:  Not applicable.||
2511|126|B|||
2511|127|R|STORAGE:  Not applicable. This type of product is given in a||
2511|128|R|hospital or clinic and will not be stored at home.||
2511|129|B|||
2511|130|M|MEDICAL ALERT:  Your condition can cause complications in a||
2511|131|M|medical emergency. For information about enrolling in MedicAlert,||
2511|132|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2511|133|B|||
2511|134|A|Information last revised November 2025.||
2511|135|A|Copyright(c) 2025 First Databank, Inc.||
2511|136|B|||
2512|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2512|002|Z|does NOT have all possible information about this product. This||
2512|003|Z|information does not assure that this product is safe, effective,||
2512|004|Z|or appropriate for you. This information is not individual||
2512|005|Z|medical advice and does not substitute for the advice of your||
2512|006|Z|health care professional. Always ask your health care||
2512|007|Z|professional for complete information about this product and your||
2512|008|Z|specific health needs.||
2512|009|B|||
2512|010|T|GLOFITAMAB - INJECTION||
2512|011|F|(gloe-FIT-a-mab)||
2512|012|B|||
2512|013|C|COMMON BRAND NAME(S): Columvi||
2512|014|B|||
2512|015|W|WARNING:  Glofitamab may cause a serious (even fatal) reaction||
2512|016|W|called cytokine release syndrome-CRS. You will be given this||
2512|017|W|medication in a hospital or clinic so your doctor can watch for||
2512|018|W|serious side effects and quickly provide treatment if needed.||
2512|019|W|Tell your doctor right away if you have any symptoms of CRS such||
2512|020|W|as high fever, trouble breathing, chills,||
2512|021|W|dizziness/lightheadedness, or fast heartbeat.||
2512|022|B|||
2512|023|U|USES:  This medication is used to treat certain types of cancer||
2512|024|U|(large B-cell lymphoma- LBCL, diffuse large B-cell lymphoma-||
2512|025|U|DLBCL). Glofitamab works by slowing or stopping the growth of||
2512|026|U|cancer cells.||
2512|027|B|||
2512|028|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2512|029|H|Patient Information Leaflet provided by your pharmacist before||
2512|030|H|you start using glofitamab and each time you get a treatment. If||
2512|031|H|you have any questions, ask your doctor or pharmacist. Carry the||
2512|032|H|Patient Wallet Card with you at all times. Show the card to all||
2512|033|H|of your health care providers to let them know that you are being||
2512|034|H|treated with glofitamab.||
2512|035|H|   This medication is given by injection into a vein as directed||
2512|036|H|by your doctor. The injection is given by a health care||
2512|037|H|professional, usually over 2 to 4 hours. To reduce your risk of||
2512|038|H|side effects, your doctor will start this medication at a low||
2512|039|H|dose and gradually increase your dose. These starting doses are||
2512|040|H|part of a "step-up dosing schedule." You will also be given a||
2512|041|H|single dose of another medication (obinutuzumab) a week before||
2512|042|H|your first "step-up dose" of glofitamab. You must stay in the||
2512|043|H|hospital/clinic during and for some time after the first "step-up||
2512|044|H|dose" so your doctor can monitor you closely and help you manage||
2512|045|H|any side effects. Your doctor will decide if you need to be||
2512|046|H|monitored after any of the following doses, based on any side||
2512|047|H|effects you may have (such as CRS). The treatment schedule is||
2512|048|H|based on your medical condition and response to treatment.||
2512|049|H|   Before you receive this medication, your doctor will prescribe||
2512|050|H|other medications (such as acetaminophen, dexamethasone,||
2512|051|H|diphenhydramine) to help prevent side effects. Your doctor may||
2512|052|H|also prescribe other medications (such as antibiotics,||
2512|053|H|antivirals) to help prevent infection. Carefully follow your||
2512|054|H|doctor's directions for all your medications.||
2512|055|H|   Use this medication regularly to get the most benefit from it.||
2512|056|H|To help you remember, mark your calendar with a reminder.||
2512|057|B|||
2512|058|S|SIDE EFFECTS:  See also Warning section.||
2512|059|S|   Tiredness or muscle/joint pain may occur. If either of these||
2512|060|S|effects lasts or gets worse, tell your doctor or pharmacist||
2512|061|S|promptly.||
2512|062|S|   People using this medication may have serious side effects.||
2512|063|S|However, you have been prescribed this drug because your doctor||
2512|064|S|has judged that the benefit to you is greater than the risk of||
2512|065|S|side effects. Careful monitoring by your doctor may decrease your||
2512|066|S|risk.||
2512|067|S|   Tell your doctor right away if you have any serious side||
2512|068|S|effects, including: easy bruising/bleeding, signs of anemia (such||
2512|069|S|as unusual tiredness, pale skin).||
2512|070|S|   This medication can also cause serious (sometimes fatal)||
2512|071|S|nervous system problems. Careful monitoring and prompt treatment||
2512|072|S|may decrease your risk. Tell your doctor right away if you have||
2512|073|S|any symptoms such as headache, numbness/tingling/weakness of||
2512|074|S|hands or feet, feeling of spinning/dizziness, mental/mood changes||
2512|075|S|(such as confusion/delirium, memory problems), trouble speaking,||
2512|076|S|shaking, or drowsiness.||
2512|077|S|   This medication may lower your ability to fight infections.||
2512|078|S|This may make you more likely to get a serious (rarely fatal)||
2512|079|S|infection or make any infection you have worse. Tell your doctor||
2512|080|S|right away if you have any signs of infection (such as sore||
2512|081|S|throat that doesn't go away, fever, chills).||
2512|082|S|   Glofitamab sometimes causes side effects due to the rapid||
2512|083|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
2512|084|S|risk, your doctor may add a medication and tell you to drink||
2512|085|S|plenty of fluids. Tell your doctor right away if you have||
2512|086|S|symptoms such as: low back/side pain (flank pain), signs of||
2512|087|S|kidney problems (such as painful urination, pink/bloody urine,||
2512|088|S|change in the amount of urine), muscle spasms/weakness.||
2512|089|S|   People using this medication may have worsening of their||
2512|090|S|symptoms (tumor flare). Tell your doctor right away if you have||
2512|091|S|symptoms of tumor flare such as: tender or swollen lymph nodes,||
2512|092|S|chest pain, cough, trouble breathing, or pain or swelling at the||
2512|093|S|site of the tumor.||
2512|094|S|   Glofitamab can commonly cause a rash that is usually not||
2512|095|S|serious. However, you may not be able to tell it apart from a||
2512|096|S|rare rash that could be a sign of a severe reaction. Get medical||
2512|097|S|help right away if you develop any rash.||
2512|098|S|   A very serious allergic reaction to this drug is rare.||
2512|099|S|However, get medical help right away if you notice any symptoms||
2512|100|S|of a serious allergic reaction, including: rash, itching/swelling||
2512|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2512|102|S|breathing.||
2512|103|S|   This is not a complete list of possible side effects. If you||
2512|104|S|notice other effects not listed above, contact your doctor or||
2512|105|S|pharmacist.||
2512|106|S|   In the US -||
2512|107|S|   Call your doctor for medical advice about side effects. You||
2512|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2512|109|S|www.fda.gov/medwatch.||
2512|110|S|   In Canada - Call your doctor for medical advice about side||
2512|111|S|effects. You may report side effects to Health Canada at||
2512|112|S|1-866-234-2345.||
2512|113|B|||
2512|114|P|PRECAUTIONS:  Before using glofitamab, tell your doctor or||
2512|115|P|pharmacist if you are allergic to it; or if you have any other||
2512|116|P|allergies. This product may contain inactive ingredients, which||
2512|117|P|can cause allergic reactions or other problems. Talk to your||
2512|118|P|pharmacist for more details.||
2512|119|P|   Before using this medication, tell your doctor or pharmacist||
2512|120|P|your medical history, especially of: current/recent infections,||
2512|121|P|kidney problems.||
2512|122|P|   This drug may make you dizzy or drowsy or affect your thinking||
2512|123|P|and coordination. Alcohol or marijuana (cannabis) can worsen||
2512|124|P|these effects. Do not drive, use machinery, or do anything that||
2512|125|P|needs alertness until you can do it safely. Limit alcoholic||
2512|126|P|beverages. Talk to your doctor if you are using marijuana||
2512|127|P|(cannabis).||
2512|128|P|   This medication can make you more likely to get infections or||
2512|129|P|may make current infections worse. Stay away from anyone who has||
2512|130|P|an infection that may easily spread (such as chickenpox,||
2512|131|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2512|132|P|exposed to an infection or for more details.||
2512|133|P|   Tell your health care professional that you are using||
2512|134|P|glofitamab before having any immunizations/vaccinations. Avoid||
2512|135|P|contact with people who have recently received live vaccines||
2512|136|P|(such as flu vaccine inhaled through the nose).||
2512|137|P|   Before having surgery, tell your doctor or dentist about all||
2512|138|P|the products you use (including prescription drugs,||
2512|139|P|nonprescription drugs, and herbal products).||
2512|140|P|   Tell your doctor if you are pregnant or plan to become||
2512|141|P|pregnant. You should not become pregnant while using glofitamab.||
2512|142|P|Glofitamab may harm an unborn baby. Your doctor should order a||
2512|143|P|pregnancy test before you start this medication. Ask about||
2512|144|P|reliable forms of birth control while using this medication and||
2512|145|P|for some time after the last dose. If you become pregnant, talk||
2512|146|P|to your doctor right away about the risks and benefits of this||
2512|147|P|medication.||
2512|148|P|   It is unknown if this drug passes into breast milk. Because of||
2512|149|P|the possible risk to the infant, breastfeeding is not recommended||
2512|150|P|while using this drug and for some time after the last dose.||
2512|151|P|Consult your doctor before breastfeeding.||
2512|152|B|||
2512|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2512|154|I|medications work or increase your risk for serious side effects.||
2512|155|I|This document does not contain all possible drug interactions.||
2512|156|I|Keep a list of all the products you use (including||
2512|157|I|prescription/nonprescription drugs and herbal products) and share||
2512|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
2512|159|I|the dosage of any medicines without your doctor's approval.||
2512|160|B|||
2512|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2512|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2512|163|O|poison control center right away. US residents can call||
2512|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2512|165|B|||
2512|166|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2512|167|N|kidney function) should be done while you are using this||
2512|168|N|medication. Keep all medical and lab appointments. Consult your||
2512|169|N|doctor for more details.||
2512|170|B|||
2512|171|D|MISSED DOSE:  It is important to get each dose of this medication||
2512|172|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2512|173|D|right away for a new dosing schedule.||
2512|174|B|||
2512|175|R|STORAGE:  Not applicable. This medication is given in a hospital||
2512|176|R|or clinic and will not be stored at home.||
2512|177|B|||
2512|178|M|MEDICAL ALERT:  Your condition can cause complications in a||
2512|179|M|medical emergency. For information about enrolling in MedicAlert,||
2512|180|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2512|181|B|||
2512|182|A|Information last revised April 2025.||
2512|183|A|Copyright(c) 2025 First Databank, Inc.||
2512|184|B|||
2513|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2513|002|Z|does NOT have all possible information about this product. This||
2513|003|Z|information does not assure that this product is safe, effective,||
2513|004|Z|or appropriate for you. This information is not individual||
2513|005|Z|medical advice and does not substitute for the advice of your||
2513|006|Z|health care professional. Always ask your health care||
2513|007|Z|professional for complete information about this product and your||
2513|008|Z|specific health needs.||
2513|009|B|||
2513|010|T|ROZANOLIXIZUMAB - SUBCUTANEOUS INJECTION||
2513|011|B|||
2513|012|C|COMMON BRAND NAME(S): Rystiggo||
2513|013|B|||
2513|014|U|USES:  Rozanolixizumab is used to treat a certain muscle||
2513|015|U|condition (generalized myasthenia gravis). It may help to improve||
2513|016|U|symptoms of muscle weakness.||
2513|017|B|||
2513|018|H|HOW TO USE:  This medication is given by injection under the skin||
2513|019|H|by a health care professional. It is given as directed by your||
2513|020|H|doctor using an infusion pump, usually once weekly for 6 weeks.||
2513|021|H|The dosage and additional treatment cycles are based on your||
2513|022|H|weight, medical condition, and response to treatment. A||
2513|023|H|healthcare professional should monitor you during each injection||
2513|024|H|and for at least 15 minutes after the injection to make sure you||
2513|025|H|don't get an allergic reaction.||
2513|026|H|   Tell your doctor if your condition does not get better or if||
2513|027|H|it gets worse.||
2513|028|B|||
2513|029|S|SIDE EFFECTS:  Headache, diarrhea, joint pain, or injection site||
2513|030|S|reactions (such as redness, pain, bruising, swelling) may occur.||
2513|031|S|If any of these effects last or get worse, tell your doctor or||
2513|032|S|pharmacist promptly.||
2513|033|S|   Remember that this medication has been prescribed because your||
2513|034|S|doctor has judged that the benefit to you is greater than the||
2513|035|S|risk of side effects. Many people using this medication do not||
2513|036|S|have serious side effects.||
2513|037|S|   This medication may lower your ability to fight infections.||
2513|038|S|This may make you more likely to get a serious infection or make||
2513|039|S|any infection you have worse. Tell your doctor right away if you||
2513|040|S|have any signs of infection (such as sore throat that doesn't go||
2513|041|S|away, fever, chills, painful/burning urination).||
2513|042|S|   Tell your doctor right away if you have any serious side||
2513|043|S|effects, including: headache that is severe or doesn't go away,||
2513|044|S|stiff/painful neck, confusion.||
2513|045|S|   A very serious allergic reaction to this drug is rare.||
2513|046|S|However, get medical help right away if you notice any symptoms||
2513|047|S|of a serious allergic reaction, including: rash, itching/swelling||
2513|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2513|049|S|breathing.||
2513|050|S|   This is not a complete list of possible side effects. If you||
2513|051|S|notice other effects not listed above, contact your doctor or||
2513|052|S|pharmacist.||
2513|053|S|   In the US -||
2513|054|S|   Call your doctor for medical advice about side effects. You||
2513|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2513|056|S|www.fda.gov/medwatch.||
2513|057|S|   In Canada - Call your doctor for medical advice about side||
2513|058|S|effects. You may report side effects to Health Canada at||
2513|059|S|1-866-234-2345.||
2513|060|B|||
2513|061|P|PRECAUTIONS:  Before using rozanolixizumab, tell your doctor or||
2513|062|P|pharmacist if you are allergic to it; or if you have any other||
2513|063|P|allergies. This product may contain inactive ingredients, which||
2513|064|P|can cause allergic reactions or other problems. Talk to your||
2513|065|P|pharmacist for more details.||
2513|066|P|   Before using this medication, tell your doctor or pharmacist||
2513|067|P|your medical history, especially of: current/recent infection.||
2513|068|P|   Rozanolixizumab can make you more likely to get infections or||
2513|069|P|may make current infections worse. Stay away from anyone who has||
2513|070|P|an infection that may easily spread (such as chickenpox,||
2513|071|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2513|072|P|exposed to an infection or for more details.||
2513|073|P|   Tell your health care professional that you are using||
2513|074|P|rozanolixizumab before having any immunizations/vaccinations.||
2513|075|P|Avoid contact with people who have recently received live||
2513|076|P|vaccines (such as flu vaccine inhaled through the nose).||
2513|077|P|   Before having surgery, tell your doctor or dentist about all||
2513|078|P|the products you use (including prescription drugs,||
2513|079|P|nonprescription drugs, and herbal products).||
2513|080|P|   During pregnancy, this medication should be used only when||
2513|081|P|clearly needed. Discuss the risks and benefits with your doctor.||
2513|082|P|   It is unknown if this drug passes into breast milk. Consult||
2513|083|P|your doctor before breastfeeding.||
2513|084|B|||
2513|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2513|086|I|medications work or increase your risk for serious side effects.||
2513|087|I|This document does not contain all possible drug interactions.||
2513|088|I|Keep a list of all the products you use (including||
2513|089|I|prescription/nonprescription drugs and herbal products) and share||
2513|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
2513|091|I|the dosage of any medicines without your doctor's approval.||
2513|092|B|||
2513|093|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2513|094|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2513|095|O|poison control center right away. US residents can call||
2513|096|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2513|097|B|||
2513|098|N|NOTES:  Keep all medical and lab appointments.||
2513|099|B|||
2513|100|D|MISSED DOSE:  It is important to get each dose of this medication||
2513|101|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2513|102|D|right away for a new dosing schedule.||
2513|103|B|||
2513|104|R|STORAGE:  Not applicable. This medication is given in a clinic||
2513|105|R|and will not be stored at home.||
2513|106|B|||
2513|107|M|MEDICAL ALERT:  Your condition can cause complications in a||
2513|108|M|medical emergency. For information about enrolling in MedicAlert,||
2513|109|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2513|110|B|||
2513|111|A|Information last revised April 2025.||
2513|112|A|Copyright(c) 2025 First Databank, Inc.||
2513|113|B|||
2514|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2514|002|Z|does NOT have all possible information about this product. This||
2514|003|Z|information does not assure that this product is safe, effective,||
2514|004|Z|or appropriate for you. This information is not individual||
2514|005|Z|medical advice and does not substitute for the advice of your||
2514|006|Z|health care professional. Always ask your health care||
2514|007|Z|professional for complete information about this product and your||
2514|008|Z|specific health needs.||
2514|009|B|||
2514|010|T|REZAFUNGIN - INJECTION||
2514|011|F|(RE-za-FUN-jin)||
2514|012|B|||
2514|013|C|COMMON BRAND NAME(S): Rezzayo||
2514|014|B|||
2514|015|U|USES:  This medication is used to treat certain fungal infections||
2514|016|U|(candidemia, invasive candidiasis). Rezafungin belongs to a class||
2514|017|U|of drugs known as echinocandins. It works by stopping the growth||
2514|018|U|of fungi.||
2514|019|B|||
2514|020|H|HOW TO USE:  This medication is given by slow injection into a||
2514|021|H|vein as directed by your doctor, usually once weekly over 1 hour.||
2514|022|H|   If you are using this medication at home, learn all||
2514|023|H|preparation and usage instructions from your health care||
2514|024|H|professional. Before using, check this product for particles or||
2514|025|H|discoloration. If either is present, do not use the liquid.||
2514|026|H|   Learn how to store and discard medical supplies safely.||
2514|027|H|   Infusion reactions may happen during the infusion of this||
2514|028|H|drug. Tell your doctor right away if you have symptoms of||
2514|029|H|infusion reactions such as chest tightness, rash, flushing, or||
2514|030|H|nausea. Your doctor may slow down or stop your treatment for some||
2514|031|H|time.||
2514|032|H|   Continue to use this medication until the full prescribed||
2514|033|H|amount is finished, even if symptoms disappear after a few days.||
2514|034|H|Stopping the medication too early may result in a return of the||
2514|035|H|infection.||
2514|036|H|   Tell your doctor if your condition does not get better or if||
2514|037|H|it gets worse.||
2514|038|B|||
2514|039|S|SIDE EFFECTS:  See also How to Use section.||
2514|040|S|   Nausea, vomiting, diarrhea, or constipation may occur. If any||
2514|041|S|of these effects last or get worse, tell your doctor or||
2514|042|S|pharmacist promptly.||
2514|043|S|   Remember that this medication has been prescribed because your||
2514|044|S|doctor has judged that the benefit to you is greater than the||
2514|045|S|risk of side effects. Many people using this medication do not||
2514|046|S|have serious side effects.||
2514|047|S|   A very serious allergic reaction to this drug is rare.||
2514|048|S|However, get medical help right away if you notice any symptoms||
2514|049|S|of a serious allergic reaction, including: rash, itching/swelling||
2514|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2514|051|S|breathing.||
2514|052|S|   This is not a complete list of possible side effects. If you||
2514|053|S|notice other effects not listed above, contact your doctor or||
2514|054|S|pharmacist.||
2514|055|S|   In the US -||
2514|056|S|   Call your doctor for medical advice about side effects. You||
2514|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2514|058|S|www.fda.gov/medwatch.||
2514|059|S|   In Canada - Call your doctor for medical advice about side||
2514|060|S|effects. You may report side effects to Health Canada at||
2514|061|S|1-866-234-2345.||
2514|062|B|||
2514|063|P|PRECAUTIONS:  Before using rezafungin, tell your doctor or||
2514|064|P|pharmacist if you are allergic to it; or to other echinocandin||
2514|065|P|antifungal drugs (such as caspofungin, micafungin); or if you||
2514|066|P|have any other allergies. This product may contain inactive||
2514|067|P|ingredients, which can cause allergic reactions or other||
2514|068|P|problems. Talk to your pharmacist for more details.||
2514|069|P|   Before using this medication, tell your doctor or pharmacist||
2514|070|P|your medical history, especially of: liver disease.||
2514|071|P|   This medication may make you more sensitive to the sun. Limit||
2514|072|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2514|073|P|sunscreen and wear protective clothing when outdoors. Tell your||
2514|074|P|doctor right away if you get sunburned or have skin||
2514|075|P|blisters/redness. Your doctor may direct you to limit or avoid||
2514|076|P|phototherapy while you use this product. Ask your doctor for||
2514|077|P|details.||
2514|078|P|   Before having surgery, tell your doctor or dentist about all||
2514|079|P|the products you use (including prescription drugs,||
2514|080|P|nonprescription drugs, and herbal products).||
2514|081|P|   During pregnancy, this medication should be used only when||
2514|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
2514|083|P|   It is unknown if this medication passes into breast milk.||
2514|084|P|Consult your doctor before breastfeeding.||
2514|085|B|||
2514|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2514|087|I|medications work or increase your risk for serious side effects.||
2514|088|I|This document does not contain all possible drug interactions.||
2514|089|I|Keep a list of all the products you use (including||
2514|090|I|prescription/nonprescription drugs and herbal products) and share||
2514|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2514|092|I|the dosage of any medicines without your doctor's approval.||
2514|093|B|||
2514|094|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2514|095|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2514|096|O|poison control center right away. US residents can call||
2514|097|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2514|098|B|||
2514|099|N|NOTES:  Do not share this medication with others.||
2514|100|N|   Lab and/or medical tests (such as liver function) may be done||
2514|101|N|while you are using this medication. Keep all medical and lab||
2514|102|N|appointments. Consult your doctor for more details.||
2514|103|N|   This medication has been prescribed for your current condition||
2514|104|N|only. Do not use it later for another infection unless your||
2514|105|N|doctor tells you to.||
2514|106|B|||
2514|107|D|MISSED DOSE:  It is important to get each dose of this medication||
2514|108|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2514|109|D|right away for a new dosing schedule. Do not double the dose to||
2514|110|D|catch up.||
2514|111|B|||
2514|112|R|STORAGE:  Consult the product instructions and your pharmacist||
2514|113|R|for storage details. Keep all medications away from children and||
2514|114|R|pets.||
2514|115|R|   Do not flush medications down the toilet or pour them into a||
2514|116|R|drain unless instructed to do so. Properly discard this product||
2514|117|R|when it is expired or no longer needed. Consult your pharmacist||
2514|118|R|or local waste disposal company.||
2514|119|B|||
2514|120|A|Information last revised November 2024.||
2514|121|A|Copyright(c) 2025 First Databank, Inc.||
2514|122|B|||
2515|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2515|002|Z|does NOT have all possible information about this product. This||
2515|003|Z|information does not assure that this product is safe, effective,||
2515|004|Z|or appropriate for you. This information is not individual||
2515|005|Z|medical advice and does not substitute for the advice of your||
2515|006|Z|health care professional. Always ask your health care||
2515|007|Z|professional for complete information about this product and your||
2515|008|Z|specific health needs.||
2515|009|B|||
2515|010|T|PALOVAROTENE - ORAL||
2515|011|F|(PAL-oh-VAR-oh-teen)||
2515|012|B|||
2515|013|C|COMMON BRAND NAME(S): Sohonos||
2515|014|B|||
2515|015|W|WARNING:  Women who are pregnant must not use palovarotene. Women||
2515|016|W|must avoid becoming pregnant while taking this medication and for||
2515|017|W|one month after stopping treatment. It can cause serious (even||
2515|018|W|fatal) birth defects, miscarriage, or premature birth of the||
2515|019|W|baby. Talk with your doctor about the risks and benefits of||
2515|020|W|taking this medication and your birth control options.||
2515|021|W|   Women who are able to have children must use one or two||
2515|022|W|reliable forms of birth control for 1 month before starting||
2515|023|W|palovarotene, during use, and for at least 1 month after the last||
2515|024|W|dose. If you are going to use only one form of birth control||
2515|025|W|(instead of using two), it must be one that is highly effective,||
2515|026|W|such as an intrauterine device (IUD). Consult your doctor for||
2515|027|W|more details.||
2515|028|W|   Women who are able to have children must also meet the||
2515|029|W|following requirements: test negative on a pregnancy test before||
2515|030|W|starting treatment, have monthly pregnancy tests during||
2515|031|W|treatment, and one month after the last dose.||
2515|032|W|   This medication may stop normal growth in children. Your||
2515|033|W|doctor will regularly monitor your child during treatment. Tell||
2515|034|W|your doctor right away if you notice your child not growing||
2515|035|W|(decreased height) or differences in the way they walk.||
2515|036|B|||
2515|037|U|USES:  Palovarotene is used to treat a certain rare genetic||
2515|038|U|problem (fibrodysplasia ossificans progressiva-FOP). It works by||
2515|039|U|reducing bone formation in muscles and tendons that can be caused||
2515|040|U|by FOP. Palovarotene belongs to a class of drugs known as||
2515|041|U|retinoids, which are related to vitamin A.||
2515|042|B|||
2515|043|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2515|044|H|Patient Information Leaflet provided by your pharmacist before||
2515|045|H|you start taking palovarotene and each time you get a refill. If||
2515|046|H|you have any questions, ask your doctor or pharmacist.||
2515|047|H|   Take this medication by mouth as directed by your doctor,||
2515|048|H|usually once daily with food. Swallow the capsules whole. Do not||
2515|049|H|crush or chew the capsules. The dosage is based on your medical||
2515|050|H|condition, response to treatment, and other medications you may||
2515|051|H|be taking. Children's dosage is also based on weight. Be sure to||
2515|052|H|tell your doctor and pharmacist about all the products you use||
2515|053|H|(including prescription drugs, nonprescription drugs, and herbal||
2515|054|H|products).||
2515|055|H|   This medication can be used for long-term treatment (chronic)||
2515|056|H|or for short-term attacks (flares). Do not take both chronic and||
2515|057|H|flare treatment at the same time.||
2515|058|H|   If you are having trouble swallowing the capsule, you may open||
2515|059|H|the capsule and carefully sprinkle its contents onto a||
2515|060|H|teaspoonful of soft food (such as applesauce, yogurt, pudding,||
2515|061|H|milk, oatmeal, rice cereal, liquid nutritional supplement) just||
2515|062|H|before you take it. Swallow all of the drug/food mixture right||
2515|063|H|away. The mixture may also be swallowed within an hour if it is||
2515|064|H|kept at room temperature, away from direct sunlight.||
2515|065|H|   If you are opening the capsules, wash your hands before and||
2515|066|H|after handling the medication. You and/or your caregiver should||
2515|067|H|wear disposable gloves when handling this medication. If powder||
2515|068|H|from the capsule spills, wipe it up right away with a wet paper||
2515|069|H|towel and throw away in a closed container, such as a plastic||
2515|070|H|bag. Clean the spill area right away with soap and water. Make||
2515|071|H|sure not to breathe the powder from the capsules.||
2515|072|H|   Use this medication regularly to get the most benefit from it.||
2515|073|H|To help you remember, take it at the same time each day.||
2515|074|H|   Do not increase your dose or use this drug more often or for||
2515|075|H|longer than prescribed. Your condition will not improve any||
2515|076|H|faster, and your risk of side effects will increase.||
2515|077|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2515|078|H|using this medication unless your doctor or pharmacist says you||
2515|079|H|may do so safely. Grapefruit can increase the chance of side||
2515|080|H|effects with this medicine. Ask your doctor or pharmacist for||
2515|081|H|more details.||
2515|082|H|   Since this drug can be absorbed through the skin and lungs and||
2515|083|H|may harm an unborn baby, women who are pregnant or who may become||
2515|084|H|pregnant should not handle this medication or breathe the dust||
2515|085|H|from the capsules.||
2515|086|H|   Tell your doctor if you do not get better or get worse||
2515|087|H|(including new flares).||
2515|088|B|||
2515|089|S|SIDE EFFECTS:  See also Warning section.||
2515|090|S|   Headache, bone/joint pain, hair loss, dry mouth, dry eyes, dry||
2515|091|S|lips/skin, or other skin changes may occur. If any of these||
2515|092|S|effects last or get worse, tell your doctor or pharmacist||
2515|093|S|promptly.||
2515|094|S|   To relieve dry eyes, you may use a lubricating eye ointment or||
2515|095|S|tear replacement eye drops. Ask your pharmacist for details.||
2515|096|S|   Remember that this medication has been prescribed because your||
2515|097|S|doctor has judged that the benefit to you is greater than the||
2515|098|S|risk of side effects. Many people using this medication do not||
2515|099|S|have serious side effects.||
2515|100|S|   Tell your doctor right away if you have any serious side||
2515|101|S|effects, including: mental/mood changes (such as depression,||
2515|102|S|anxiety, thoughts of suicide), vision changes (such as||
2515|103|S|blurred/double vision, decreased vision).||
2515|104|S|   A very serious allergic reaction to this drug is rare.||
2515|105|S|However, get medical help right away if you notice any symptoms||
2515|106|S|of a serious allergic reaction, including: rash, itching/swelling||
2515|107|S|(especially of the face/tongue/throat), dizziness, trouble||
2515|108|S|breathing.||
2515|109|S|   This is not a complete list of possible side effects. If you||
2515|110|S|notice other effects not listed above, contact your doctor or||
2515|111|S|pharmacist.||
2515|112|S|   In the US -||
2515|113|S|   Call your doctor for medical advice about side effects. You||
2515|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2515|115|S|www.fda.gov/medwatch.||
2515|116|S|   In Canada - Call your doctor for medical advice about side||
2515|117|S|effects. You may report side effects to Health Canada at||
2515|118|S|1-866-234-2345.||
2515|119|B|||
2515|120|P|PRECAUTIONS:  See also Warning section.||
2515|121|P|   Before taking palovarotene, tell your doctor or pharmacist if||
2515|122|P|you are allergic to it; or to vitamin A-related drugs (other||
2515|123|P|retinoids such as isotretinoin); or if you have any other||
2515|124|P|allergies. This product may contain inactive ingredients (such as||
2515|125|P|lactose), which can cause allergic reactions or other problems.||
2515|126|P|Talk to your pharmacist for more details.||
2515|127|P|   Before using this medication, tell your doctor or pharmacist||
2515|128|P|your medical history, especially of: kidney disease, liver||
2515|129|P|disease, mental/mood problems (such as depression), bone loss||
2515|130|P|conditions (such as osteoporosis/osteomalacia, decreased bone||
2515|131|P|density).||
2515|132|P|   Do not donate blood while you are taking this medication and||
2515|133|P|for at least 1 week after you stop taking it. This will prevent||
2515|134|P|the possibility of your blood being given to a pregnant woman.||
2515|135|P|   This medication may make you more sensitive to the sun. Limit||
2515|136|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2515|137|P|sunscreen and wear protective clothing when outdoors. Tell your||
2515|138|P|doctor right away if you get sunburned or have skin||
2515|139|P|blisters/redness.||
2515|140|P|   Palovarotene may cause vision changes, including decreased||
2515|141|P|night vision. Do not drive, use machinery, or do anything that||
2515|142|P|needs clear vision (especially at night) until you can do it||
2515|143|P|safely.||
2515|144|P|   Before having surgery, tell your doctor or dentist about all||
2515|145|P|the products you use (including prescription drugs,||
2515|146|P|nonprescription drugs, and herbal products). Your doctor may||
2515|147|P|start you on treatment to prevent flares before surgery,||
2515|148|P|vaccinations, or other illnesses. Consult your doctor for more||
2515|149|P|details.||
2515|150|P|   This medication must not be used during pregnancy. It may harm||
2515|151|P|an unborn baby. Discuss with your doctor the use of one or two||
2515|152|P|reliable forms of birth control (such as condoms, birth control||
2515|153|P|pills, intrauterine devices) for 1 month before starting||
2515|154|P|palovarotene, during use, and for at least 1 month after the last||
2515|155|P|dose. If you become pregnant or think you may be pregnant, tell||
2515|156|P|your doctor right away.||
2515|157|P|   Since this drug can be absorbed through the skin and lungs and||
2515|158|P|may harm an unborn baby, women who are pregnant or who may become||
2515|159|P|pregnant should not handle this medication or breathe the dust||
2515|160|P|from the capsules.||
2515|161|P|   It is unknown if this drug passes into breast milk. Because of||
2515|162|P|the possible risk to the infant, breastfeeding is not recommended||
2515|163|P|while using this drug and for 1 month after the last dose.||
2515|164|P|Consult your doctor before breastfeeding.||
2515|165|B|||
2515|166|I|DRUG INTERACTIONS:  See also How to Use section.||
2515|167|I|   Drug interactions may change how your medications work or||
2515|168|I|increase your risk for serious side effects. This document does||
2515|169|I|not contain all possible drug interactions. Keep a list of all||
2515|170|I|the products you use (including prescription/nonprescription||
2515|171|I|drugs and herbal products) and share it with your doctor and||
2515|172|I|pharmacist. Do not start, stop, or change the dosage of any||
2515|173|I|medicines without your doctor's approval.||
2515|174|I|   Some products that may interact with this drug are:||
2515|175|I|tetracycline antibiotics, vitamin A, other retinoid drugs (such||
2515|176|I|as acitretin, alitretinoin).||
2515|177|I|   Other medications can affect the removal of palovarotene from||
2515|178|I|your body, which may affect how palovarotene works. Examples||
2515|179|I|include azole antifungals (such as ketoconazole, itraconazole),||
2515|180|I|macrolide antibiotics (such as clarithromycin), rifamycins (such||
2515|181|I|as rifampin), St. John's wort, among others.||
2515|182|B|||
2515|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2515|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2515|185|O|poison control center right away. US residents can call||
2515|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2515|187|B|||
2515|188|N|NOTES:  Do not share this medication with others.||
2515|189|N|   Lab and/or medical tests (such as x-rays, height measurement,||
2515|190|N|liver/kidney function) must be done before you start taking this||
2515|191|N|medication and while you are taking it. Keep all medical and lab||
2515|192|N|appointments. Consult your doctor for more details.||
2515|193|B|||
2515|194|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2515|195|D|remember. If it is more than 6 hours after the missed dose, skip||
2515|196|D|the missed dose. Take your next dose at the regular time. Do not||
2515|197|D|double the dose to catch up.||
2515|198|B|||
2515|199|R|STORAGE:  Store at room temperature away from light and moisture.||
2515|200|R|Keep the blister packages in the original carton until ready to||
2515|201|R|use. Do not store in the bathroom. Keep all medications away from||
2515|202|R|children and pets.||
2515|203|R|   Do not flush medications down the toilet or pour them into a||
2515|204|R|drain unless instructed to do so. Properly discard this product||
2515|205|R|when it is expired or no longer needed. Consult your pharmacist||
2515|206|R|or local waste disposal company.||
2515|207|B|||
2515|208|A|Information last revised September 2024.||
2515|209|A|Copyright(c) 2025 First Databank, Inc.||
2515|210|B|||
2516|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2516|002|Z|does NOT have all possible information about this product. This||
2516|003|Z|information does not assure that this product is safe, effective,||
2516|004|Z|or appropriate for you. This information is not individual||
2516|005|Z|medical advice and does not substitute for the advice of your||
2516|006|Z|health care professional. Always ask your health care||
2516|007|Z|professional for complete information about this product and your||
2516|008|Z|specific health needs.||
2516|009|B|||
2516|010|T|RITLECITINIB - ORAL||
2516|011|F|(RIT-le-SYE-ti-nib)||
2516|012|B|||
2516|013|C|COMMON BRAND NAME(S): Litfulo||
2516|014|B|||
2516|015|W|WARNING:  Ritlecitinib may lower your ability to fight||
2516|016|W|infections. This may make you more likely to get a serious||
2516|017|W|(rarely fatal) infection or make any infection you have worse.||
2516|018|W|People taking ritlecitinib have had very serious (possibly fatal)||
2516|019|W|infections (such as appendicitis, herpes zoster, pneumonia,||
2516|020|W|sepsis, tuberculosis). The risk for infections may be higher if||
2516|021|W|you also take other drugs that suppress the immune system (such||
2516|022|W|as cyclosporine). Tell your doctor right away if you have any||
2516|023|W|signs of infection (such as a sore throat that doesn't go away,||
2516|024|W|fever, chills, cough, unusual sweating, painful skin||
2516|025|W|rash/blisters).||
2516|026|W|   You should have a tuberculosis (TB) skin test before and||
2516|027|W|during treatment with this medication. Tell your doctor if you||
2516|028|W|have been near someone with tuberculosis or have lived or||
2516|029|W|traveled in areas where certain fungal infections (such as||
2516|030|W|coccidioidomycosis, histoplasmosis) are common. These areas||
2516|031|W|include the Ohio and Mississippi River valleys and the||
2516|032|W|southwestern United States.||
2516|033|W|   Though it is very unlikely to occur, there may be a risk of||
2516|034|W|developing cancer (such as lymphoma, skin cancer, lung cancer)||
2516|035|W|with this medication. Your risk may be higher if you are a||
2516|036|W|current or past smoker. Tell your doctor right away if you||
2516|037|W|develop symptoms such as cough that doesn't go away, wheezing,||
2516|038|W|unusual lumps/growths, unexplained weight loss, night sweats,||
2516|039|W|change in appearance or size of moles, or unusual skin changes.||
2516|040|W|   Ritlecitinib may cause serious (sometimes fatal) problems from||
2516|041|W|blood clots (such as heart attack, stroke, blood clots in the||
2516|042|W|lungs or legs). You may be at an increased risk for blood clots||
2516|043|W|if you are a current or past smoker, or are 50 years of age or||
2516|044|W|older and have at least one risk factor for heart disease.||
2516|045|W|Discuss the risks and benefits of treatment with your doctor. Get||
2516|046|W|medical help right away if any of these symptoms occur: shortness||
2516|047|W|of breath/rapid breathing, chest/jaw/left arm pain, unusual||
2516|048|W|sweating, confusion, sudden dizziness/fainting,||
2516|049|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2516|050|W|trouble speaking, weakness on one side of the body, or sudden||
2516|051|W|vision changes.||
2516|052|B|||
2516|053|U|USES:  This medication is used to treat a certain immune system||
2516|054|U|problem that causes hair loss (alopecia areata). Ritlecitinib||
2516|055|U|belongs to a class of drugs known as kinase inhibitors.||
2516|056|B|||
2516|057|H|HOW TO USE:  Read the Medication Guide provided by your||
2516|058|H|pharmacist before you start taking ritlecitinib and each time you||
2516|059|H|get a refill. If you have any questions, ask your doctor or||
2516|060|H|pharmacist.||
2516|061|H|   Take this medication by mouth with or without food as directed||
2516|062|H|by your doctor, usually once daily. Swallow the capsules whole.||
2516|063|H|Do not crush, split, or chew the capsules.||
2516|064|H|   Use this medication regularly to get the most benefit from it.||
2516|065|H|To help you remember, take it at the same time each day.||
2516|066|H|   Do not increase your dose or use this drug more often or for||
2516|067|H|longer than prescribed. Your condition will not improve any||
2516|068|H|faster, and your risk of side effects will increase.||
2516|069|H|   Tell your doctor if your condition does not get better or if||
2516|070|H|it gets worse.||
2516|071|B|||
2516|072|S|SIDE EFFECTS:  See also Warning section.||
2516|073|S|   Diarrhea or dizziness may occur. If either of these effects||
2516|074|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
2516|075|S|   People using this medication may have serious side effects.||
2516|076|S|However, you have been prescribed this drug because your doctor||
2516|077|S|has judged that the benefit to you is greater than the risk of||
2516|078|S|side effects. Careful monitoring by your doctor may decrease your||
2516|079|S|risk.||
2516|080|S|   A very serious allergic reaction to this drug is rare.||
2516|081|S|However, get medical help right away if you notice any symptoms||
2516|082|S|of a serious allergic reaction, including: rash, itching/swelling||
2516|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2516|084|S|breathing.||
2516|085|S|   This is not a complete list of possible side effects. If you||
2516|086|S|notice other effects not listed above, contact your doctor or||
2516|087|S|pharmacist.||
2516|088|S|   In the US -||
2516|089|S|   Call your doctor for medical advice about side effects. You||
2516|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2516|091|S|www.fda.gov/medwatch.||
2516|092|S|   In Canada - Call your doctor for medical advice about side||
2516|093|S|effects. You may report side effects to Health Canada at||
2516|094|S|1-866-234-2345.||
2516|095|B|||
2516|096|P|PRECAUTIONS:  See also Warning section.||
2516|097|P|   Before taking ritlecitinib, tell your doctor or pharmacist if||
2516|098|P|you are allergic to it; or if you have any other allergies. This||
2516|099|P|product may contain inactive ingredients, which can cause||
2516|100|P|allergic reactions or other problems. Talk to your pharmacist for||
2516|101|P|more details.||
2516|102|P|   Before using this medication, tell your doctor or pharmacist||
2516|103|P|your medical history, especially of: blood clots (such as in the||
2516|104|P|lungs, legs), blood/bone marrow problems (such as low platelets||
2516|105|P|or low white blood cell counts), cancer, heart problems (such as||
2516|106|P|previous heart attack), liver disease (such as hepatitis B or C),||
2516|107|P|past/recent/current infections (such as herpes zoster, HIV||
2516|108|P|infection, tuberculosis), current or past smoking, stroke.||
2516|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2516|110|P|can make you more dizzy. Do not drive, use machinery, or do||
2516|111|P|anything that needs alertness until you can do it safely. Limit||
2516|112|P|alcoholic beverages. Talk to your doctor if you are using||
2516|113|P|marijuana (cannabis).||
2516|114|P|   Ritlecitinib can make you more likely to get infections or may||
2516|115|P|make current infections worse. Stay away from anyone who has an||
2516|116|P|infection that may easily spread (such as chickenpox, COVID-19,||
2516|117|P|measles, flu). Talk to your doctor if you have been exposed to an||
2516|118|P|infection or for more details.||
2516|119|P|   Tell your health care professional that you are using||
2516|120|P|ritlecitinib before having any immunizations/vaccinations. Avoid||
2516|121|P|contact with people who have recently received live vaccines||
2516|122|P|(such as flu vaccine inhaled through the nose).||
2516|123|P|   This medication may increase your risk of developing skin||
2516|124|P|cancer. Limit your time in the sun. Avoid tanning booths and||
2516|125|P|sunlamps. Use sunscreen and wear protective clothing when||
2516|126|P|outdoors.||
2516|127|P|   Before having surgery, tell your doctor or dentist about all||
2516|128|P|the products you use (including prescription drugs,||
2516|129|P|nonprescription drugs, and herbal products).||
2516|130|P|   Tell your doctor if you are pregnant or plan to become||
2516|131|P|pregnant. During pregnancy, this medication should be used only||
2516|132|P|when clearly needed. Discuss the risks and benefits with your||
2516|133|P|doctor.||
2516|134|P|   It is unknown if this medication passes into breast milk.||
2516|135|P|Because of the possible risk to the infant, breastfeeding is not||
2516|136|P|recommended while using this medication and for 14 hours after||
2516|137|P|the last dose. Consult your doctor before breastfeeding.||
2516|138|B|||
2516|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2516|140|I|medications work or increase your risk for serious side effects.||
2516|141|I|This document does not contain all possible drug interactions.||
2516|142|I|Keep a list of all the products you use (including||
2516|143|I|prescription/nonprescription drugs and herbal products) and share||
2516|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
2516|145|I|the dosage of any medicines without your doctor's approval.||
2516|146|I|   A product that may interact with this drug is: rifampin.||
2516|147|B|||
2516|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2516|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2516|150|O|poison control center right away. US residents can call||
2516|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2516|152|B|||
2516|153|N|NOTES:  Do not share this medication with others.||
2516|154|N|   Lab and/or medical tests (such as complete blood count, liver||
2516|155|N|function, CPK level, skin exam) should be done before you start||
2516|156|N|taking this medication and while you are taking it. Keep all||
2516|157|N|medical and lab appointments. Consult your doctor for more||
2516|158|N|details.||
2516|159|B|||
2516|160|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2516|161|D|remember. If it is less than 8 hours before the next dose, skip||
2516|162|D|the missed dose. Take your next dose at the regular time. Do not||
2516|163|D|double the dose to catch up.||
2516|164|B|||
2516|165|R|STORAGE:  Store in the original package at room temperature away||
2516|166|R|from light and moisture. Do not store in the bathroom. Keep all||
2516|167|R|medications away from children and pets.||
2516|168|R|   Do not flush medications down the toilet or pour them into a||
2516|169|R|drain unless instructed to do so. Properly discard this product||
2516|170|R|when it is expired or no longer needed. Consult your pharmacist||
2516|171|R|or local waste disposal company.||
2516|172|B|||
2516|173|A|Information last revised April 2025.||
2516|174|A|Copyright(c) 2025 First Databank, Inc.||
2516|175|B|||
2517|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2517|002|Z|does NOT have all possible information about this product. This||
2517|003|Z|information does not assure that this product is safe, effective,||
2517|004|Z|or appropriate for you. This information is not individual||
2517|005|Z|medical advice and does not substitute for the advice of your||
2517|006|Z|health care professional. Always ask your health care||
2517|007|Z|professional for complete information about this product and your||
2517|008|Z|specific health needs.||
2517|009|B|||
2517|010|T|DEFERIPRONE EXTENDED-RELEASE (TWICE A DAY) - ORAL||
2517|011|F|(de-FER-i-prone)||
2517|012|B|||
2517|013|C|COMMON BRAND NAME(S): Ferriprox (2 times a day)||
2517|014|B|||
2517|015|W|WARNING:  This medication may rarely cause a very serious low||
2517|016|W|white blood cell count, which increases your risk of serious,||
2517|017|W|possibly fatal infections. To lower your risk, your doctor will||
2517|018|W|check your blood counts with a blood test before treatment and||
2517|019|W|regularly during treatment. Get medical help right away if you||
2517|020|W|develop any signs of infection (such as sore throat that doesn't||
2517|021|W|go away, fever, chills).||
2517|022|B|||
2517|023|U|USES:  This medication is used by people with certain blood||
2517|024|U|disorders (such as thalassemia, sickle cell anemia) who have too||
2517|025|U|much iron in the body, caused by repeated blood transfusions.||
2517|026|U|Blood transfusions help people with blood disorders but they also||
2517|027|U|bring extra iron into the body. It is important to get rid of the||
2517|028|U|extra iron because high levels of iron can cause health problems||
2517|029|U|(such as heart failure, liver disease, diabetes, delayed growth||
2517|030|U|in children). Deferiprone is used if you have trouble taking||
2517|031|U|other traditional iron-removal medications or you continue to||
2517|032|U|have high iron levels after taking other iron-removal||
2517|033|U|medications.||
2517|034|U|   Deferiprone belongs to a class of drugs known as iron||
2517|035|U|chelators. It works by attaching to iron which helps your body||
2517|036|U|pass the extra iron out in the urine.||
2517|037|B|||
2517|038|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2517|039|H|Patient Information Leaflet provided by your pharmacist before||
2517|040|H|you start taking deferiprone and each time you get a refill. If||
2517|041|H|you have any questions, ask your doctor or pharmacist.||
2517|042|H|   Deferiprone is available in two different formulations:||
2517|043|H|extended-release or immediate-release. Do not switch between the||
2517|044|H|different forms of deferiprone without consulting your doctor. In||
2517|045|H|the US, the extended-release formulation is also called the||
2517|046|H|"twice-a-day" formulation.||
2517|047|H|   Take this medication by mouth with food as directed by your||
2517|048|H|doctor, usually twice daily: once in the morning and once in the||
2517|049|H|evening (about 12 hours apart). Avoid drinking alcoholic||
2517|050|H|beverages. Doing so may change how well the medication works and||
2517|051|H|increase the risk of side effects.||
2517|052|H|   Do not crush or chew extended-release tablets. Doing so can||
2517|053|H|release all of the drug at once, increasing the risk of side||
2517|054|H|effects. Also, do not split the tablets unless they have a score||
2517|055|H|line and your doctor or pharmacist tells you to do so. Swallow||
2517|056|H|the whole or split tablet without crushing or chewing.||
2517|057|H|   The dosage is based on your medical condition, weight, and||
2517|058|H|response to treatment (including lab test results). To reduce||
2517|059|H|your risk of side effects, your doctor may direct you to start||
2517|060|H|this medication at a low dose and gradually increase your dose.||
2517|061|H|Your treatment may need to be adjusted or stopped if you develop||
2517|062|H|serious side effects. Follow your doctor's instructions||
2517|063|H|carefully.||
2517|064|H|   Take this medication regularly to get the most benefit from||
2517|065|H|it. To help you remember, take it at the same times each day.||
2517|066|H|   Take this medication 4 hours apart from products that may bind||
2517|067|H|to it, decreasing its effectiveness. Ask your pharmacist about||
2517|068|H|the other products you take. Some examples include antacids,||
2517|069|H|vitamins/minerals (such as those containing iron, aluminum,||
2517|070|H|zinc), among others.||
2517|071|B|||
2517|072|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2517|073|S|   Nausea, vomiting, stomach/abdominal pain, or joint pain may||
2517|074|S|occur. If any of these effects last or get worse, tell your||
2517|075|S|doctor or pharmacist promptly.||
2517|076|S|   This medication may cause your urine to turn a reddish-brown||
2517|077|S|color. This effect is harmless and will disappear when the||
2517|078|S|medication is stopped.||
2517|079|S|   Remember that this medication has been prescribed because your||
2517|080|S|doctor has judged that the benefit to you is greater than the||
2517|081|S|risk of side effects. Many people using this medication do not||
2517|082|S|have serious side effects.||
2517|083|S|   A very serious allergic reaction to this drug is rare.||
2517|084|S|However, get medical help right away if you notice any symptoms||
2517|085|S|of a serious allergic reaction, including: rash, itching/swelling||
2517|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2517|087|S|breathing.||
2517|088|S|   This is not a complete list of possible side effects. If you||
2517|089|S|notice other effects not listed above, contact your doctor or||
2517|090|S|pharmacist.||
2517|091|S|   In the US -||
2517|092|S|   Call your doctor for medical advice about side effects. You||
2517|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2517|094|S|www.fda.gov/medwatch.||
2517|095|S|   In Canada - Call your doctor for medical advice about side||
2517|096|S|effects. You may report side effects to Health Canada at||
2517|097|S|1-866-234-2345.||
2517|098|B|||
2517|099|P|PRECAUTIONS:  Before taking deferiprone, tell your doctor or||
2517|100|P|pharmacist if you are allergic to it; or if you have any other||
2517|101|P|allergies. This product may contain inactive ingredients, which||
2517|102|P|can cause allergic reactions or other problems. Talk to your||
2517|103|P|pharmacist for more details.||
2517|104|P|   Before using this medication, tell your doctor or pharmacist||
2517|105|P|your medical history, especially of: liver disease, low white||
2517|106|P|blood cell count.||
2517|107|P|   Before having surgery, tell your doctor or dentist about all||
2517|108|P|the products you use (including prescription drugs,||
2517|109|P|nonprescription drugs, and herbal products).||
2517|110|P|   Tell your doctor if you are pregnant or plan to become||
2517|111|P|pregnant. You should not become pregnant while using deferiprone.||
2517|112|P|Deferiprone may harm an unborn baby. Your doctor should order a||
2517|113|P|pregnancy test before you start this medication. Women using this||
2517|114|P|medication should ask about reliable forms of birth control||
2517|115|P|during treatment and for 6 months after the last dose. Men using||
2517|116|P|this medication should ask about reliable forms of birth control||
2517|117|P|during treatment and for 3 months after the last dose. If you or||
2517|118|P|your partner becomes pregnant, talk to your doctor right away||
2517|119|P|about the risks and benefits of this medication.||
2517|120|P|   It is unknown if deferiprone passes into breast milk. Because||
2517|121|P|of the possible risk to the infant, breastfeeding is not||
2517|122|P|recommended while using this medication and for 2 weeks after the||
2517|123|P|last dose. Consult your doctor before breastfeeding.||
2517|124|B|||
2517|125|I|DRUG INTERACTIONS:  See also How to Use section.||
2517|126|I|   Drug interactions may change how your medications work or||
2517|127|I|increase your risk for serious side effects. This document does||
2517|128|I|not contain all possible drug interactions. Keep a list of all||
2517|129|I|the products you use (including prescription/nonprescription||
2517|130|I|drugs and herbal products) and share it with your doctor and||
2517|131|I|pharmacist. Do not start, stop, or change the dosage of any||
2517|132|I|medicines without your doctor's approval.||
2517|133|B|||
2517|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2517|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2517|136|O|poison control center right away. US residents can call||
2517|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2517|138|O|Symptoms of overdose may include: vision problems, weak muscles,||
2517|139|O|unusual/slowed movements.||
2517|140|B|||
2517|141|N|NOTES:  Do not share this medication with others.||
2517|142|N|   Lab and/or medical tests (such as liver function, complete||
2517|143|N|blood counts, ferritin/zinc levels) should be done while you are||
2517|144|N|taking this medication. Keep all medical and lab appointments.||
2517|145|N|Consult your doctor for more details.||
2517|146|B|||
2517|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2517|148|D|remember. If it is near the time of the next dose, skip the||
2517|149|D|missed dose. Take your next dose at the regular time. Do not||
2517|150|D|double the dose to catch up.||
2517|151|B|||
2517|152|R|STORAGE:  Different brands of this medication have different||
2517|153|R|storage needs. Check the product package for instructions on how||
2517|154|R|to store your brand, or ask your pharmacist. Keep all medications||
2517|155|R|away from children and pets.||
2517|156|R|   Do not flush medications down the toilet or pour them into a||
2517|157|R|drain unless instructed to do so. Properly discard this product||
2517|158|R|when it is expired or no longer needed. Consult your pharmacist||
2517|159|R|or local waste disposal company.||
2517|160|B|||
2517|161|A|Information last revised April 2025.||
2517|162|A|Copyright(c) 2025 First Databank, Inc.||
2517|163|B|||
2518|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2518|002|Z|does NOT have all possible information about this product. This||
2518|003|Z|information does not assure that this product is safe, effective,||
2518|004|Z|or appropriate for you. This information is not individual||
2518|005|Z|medical advice and does not substitute for the advice of your||
2518|006|Z|health care professional. Always ask your health care||
2518|007|Z|professional for complete information about this product and your||
2518|008|Z|specific health needs.||
2518|009|B|||
2518|010|T|NADOFARAGENE FIRADENOVEC - INTRAVESICAL||
2518|011|F|(NAD-oh-FAR-a-jeen FYE-ra-DEN-oh-vek)||
2518|012|B|||
2518|013|C|COMMON BRAND NAME(S): Adstiladrin||
2518|014|B|||
2518|015|U|USES:  This product is used to treat a certain type of cancer||
2518|016|U|(bladder cancer). Nadofaragene firadenovec is made from a certain||
2518|017|U|virus that has been specially prepared. The virus is used to||
2518|018|U|carry a certain human gene (interferon alfa) into cells. This||
2518|019|U|type of treatment is known as gene therapy.||
2518|020|B|||
2518|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2518|022|H|from your pharmacist before you start using this product and each||
2518|023|H|time you get a treatment. If you have any questions, ask your||
2518|024|H|doctor or pharmacist.||
2518|025|H|   This product is given into the bladder through a tube||
2518|026|H|(catheter) by a health care professional. It is given as directed||
2518|027|H|by your doctor, usually every 3 months.||
2518|028|H|   The product is left in the bladder for 1 hour and then||
2518|029|H|released by urinating. During the 1 hour, your doctor may have||
2518|030|H|you change positions every 15 minutes to make sure the product||
2518|031|H|gets to all parts of the bladder. Follow your doctor's||
2518|032|H|instructions carefully.||
2518|033|H|   Small amounts of virus may shed in the urine. Since the urine||
2518|034|H|may contain a virus that may infect you or others, you must||
2518|035|H|disinfect the toilet bowl every time you urinate for the first 2||
2518|036|H|days after treatment. Add half a cup of bleach to the toilet bowl||
2518|037|H|before you urinate. After urinating, wait 15 minutes before you||
2518|038|H|flush the toilet. Talk to your doctor about other important||
2518|039|H|things you must do to prevent infection.||
2518|040|B|||
2518|041|S|SIDE EFFECTS:  Tiredness, urinary discharge,||
2518|042|S|difficult/painful/frequent urination, or bladder spasms may||
2518|043|S|occur. If any of these effects last or get worse, tell your||
2518|044|S|doctor or pharmacist promptly.||
2518|045|S|   Remember that this medication has been prescribed because your||
2518|046|S|doctor has judged that the benefit to you is greater than the||
2518|047|S|risk of side effects. Many people using this medication do not||
2518|048|S|have serious side effects.||
2518|049|S|   Tell your doctor right away if you have any serious side||
2518|050|S|effects, including: pink/bloody urine, signs of infection (such||
2518|051|S|as such as sore throat that doesn't go away, fever, chills).||
2518|052|S|   A very serious allergic reaction to this drug is rare.||
2518|053|S|However, get medical help right away if you notice any symptoms||
2518|054|S|of a serious allergic reaction, including: rash, itching/swelling||
2518|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2518|056|S|breathing.||
2518|057|S|   This is not a complete list of possible side effects. If you||
2518|058|S|notice other effects not listed above, contact your doctor or||
2518|059|S|pharmacist.||
2518|060|S|   In the US -||
2518|061|S|   Call your doctor for medical advice about side effects. You||
2518|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2518|063|S|www.fda.gov/medwatch.||
2518|064|S|   In Canada - Call your doctor for medical advice about side||
2518|065|S|effects. You may report side effects to Health Canada at||
2518|066|S|1-866-234-2345.||
2518|067|B|||
2518|068|P|PRECAUTIONS:  Before receiving nadofaragene firadenovec, tell||
2518|069|P|your doctor or pharmacist if you are allergic to it; or to||
2518|070|P|interferon alfa; or if you have any other allergies. This product||
2518|071|P|may contain inactive ingredients, which can cause allergic||
2518|072|P|reactions or other problems. Talk to your pharmacist for more||
2518|073|P|details.||
2518|074|P|   Before using this product, tell your doctor or pharmacist your||
2518|075|P|medical history, especially of: immune system problems (such as||
2518|076|P|HIV, certain cancers such as leukemia/lymphoma).||
2518|077|P|   Before having surgery, tell your doctor or dentist about all||
2518|078|P|the products you use (including prescription drugs,||
2518|079|P|nonprescription drugs, and herbal products).||
2518|080|P|   Tell your doctor if you are pregnant or plan to become||
2518|081|P|pregnant. You should not become pregnant while using nadofaragene||
2518|082|P|firadenovec. Nadofaragene firadenovec may harm an unborn baby.||
2518|083|P|Your doctor should order a pregnancy test before you start this||
2518|084|P|medication. Women using this medication should ask about reliable||
2518|085|P|forms of birth control during treatment and for 6 months after||
2518|086|P|the last dose. Men using this medication should ask about||
2518|087|P|reliable forms of birth control during treatment and for 3 months||
2518|088|P|after the last dose. If you or your partner becomes pregnant,||
2518|089|P|talk to your doctor right away about the risks and benefits of||
2518|090|P|this medication.||
2518|091|P|   It is unknown if this product passes into breast milk. Consult||
2518|092|P|your doctor before breastfeeding.||
2518|093|B|||
2518|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2518|095|I|medications work or increase your risk for serious side effects.||
2518|096|I|This document does not contain all possible drug interactions.||
2518|097|I|Keep a list of all the products you use (including||
2518|098|I|prescription/nonprescription drugs and herbal products) and share||
2518|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2518|100|I|the dosage of any medicines without your doctor's approval.||
2518|101|B|||
2518|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2518|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2518|104|O|poison control center right away. US residents can call||
2518|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2518|106|B|||
2518|107|N|NOTES:  Lab and/or medical tests (such as triglyceride levels,||
2518|108|N|blood sugar levels) should be done while you are using this||
2518|109|N|product. Keep all medical and lab appointments.||
2518|110|B|||
2518|111|D|MISSED DOSE:  It is important to get each dose of this product as||
2518|112|D|scheduled. If you miss a dose, ask your doctor or pharmacist||
2518|113|D|right away for a new dosing schedule.||
2518|114|B|||
2518|115|R|STORAGE:  Not applicable. This product is given in a hospital or||
2518|116|R|clinic and will not be stored at home.||
2518|117|B|||
2518|118|M|MEDICAL ALERT:  Your condition can cause complications in a||
2518|119|M|medical emergency. For information about enrolling in MedicAlert,||
2518|120|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2518|121|B|||
2518|122|A|Information last revised May 2024.||
2518|123|A|Copyright(c) 2025 First Databank, Inc.||
2518|124|B|||
2519|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2519|002|Z|does NOT have all possible information about this product. This||
2519|003|Z|information does not assure that this product is safe, effective,||
2519|004|Z|or appropriate for you. This information is not individual||
2519|005|Z|medical advice and does not substitute for the advice of your||
2519|006|Z|health care professional. Always ask your health care||
2519|007|Z|professional for complete information about this product and your||
2519|008|Z|specific health needs.||
2519|009|B|||
2519|010|T|QUIZARTINIB - ORAL||
2519|011|F|(kwiz-AR-ti-nib)||
2519|012|B|||
2519|013|C|COMMON BRAND NAME(S): Vanflyta||
2519|014|B|||
2519|015|W|WARNING:  Quizartinib may cause a condition that affects the||
2519|016|W|heart rhythm (QT prolongation). QT prolongation can rarely cause||
2519|017|W|serious (rarely fatal) fast/irregular heartbeat and other||
2519|018|W|symptoms (such as severe dizziness, fainting) that need medical||
2519|019|W|attention right away.||
2519|020|W|   The risk of QT prolongation may be increased if you have||
2519|021|W|certain medical conditions or are taking other drugs that may||
2519|022|W|cause QT prolongation. Do not use quizartinib if you have certain||
2519|023|W|heart problems (long QT syndrome, fast/irregular heartbeat).||
2519|024|W|Before using quizartinib, tell your doctor or pharmacist of all||
2519|025|W|the drugs you take and if you have certain heart problems (heart||
2519|026|W|failure, slow heartbeat, QT prolongation in the EKG), or family||
2519|027|W|history of certain heart problems (QT prolongation in the EKG,||
2519|028|W|sudden cardiac death).||
2519|029|W|   Low levels of potassium or magnesium in the blood may also||
2519|030|W|increase your risk of QT prolongation. This risk may increase if||
2519|031|W|you use certain drugs (such as diuretics/"water pills") or if you||
2519|032|W|have conditions such as severe sweating, diarrhea, or vomiting.||
2519|033|W|Do not use quizartinib if you have low levels of potassium or||
2519|034|W|magnesium in the blood.||
2519|035|W|   To lower your risk, your doctor will order certain blood tests||
2519|036|W|(potassium/magnesium levels) and a heart test (EKG) before and||
2519|037|W|during treatment with quizartinib. Get medical help right away if||
2519|038|W|you have fast/irregular heartbeat, severe dizziness, or fainting.||
2519|039|W|   To receive quizartinib in the United States, you must||
2519|040|W|understand, agree to, and carefully follow the requirements of||
2519|041|W|the REMS Program for this medication. If you live in Canada or||
2519|042|W|any other country, consult your doctor and pharmacist for your||
2519|043|W|country's regulations.||
2519|044|B|||
2519|045|U|USES:  Quizartinib is used to treat acute myeloid leukemia (AML).||
2519|046|U|It works by slowing or stopping the growth of cancer cells.||
2519|047|B|||
2519|048|H|HOW TO USE:  Read the Medication Guide and Warning Card provided||
2519|049|H|by your pharmacist before you start taking quizartinib and each||
2519|050|H|time you get a refill. Carry the Warning Card with you at all||
2519|051|H|times. If you have any questions, ask your doctor or pharmacist.||
2519|052|H|   Take this medication by mouth with or without food as directed||
2519|053|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2519|054|H|not crush, chew, or split the tablets.||
2519|055|H|   The dosage is based on your medical condition, response to||
2519|056|H|treatment, lab tests, and other medications you may be taking. Be||
2519|057|H|sure to tell your doctor and pharmacist about all the products||
2519|058|H|you use (including prescription drugs, nonprescription drugs, and||
2519|059|H|herbal products).||
2519|060|H|   Do not increase your dose or take this drug more often or for||
2519|061|H|longer than prescribed. Your condition will not improve any||
2519|062|H|faster, and your risk of serious side effects will increase.||
2519|063|H|   If you vomit after taking a dose, do not take another dose.||
2519|064|H|Take your next dose at the regular time. Do not double the dose||
2519|065|H|to catch up.||
2519|066|H|   Use this medication regularly to get the most benefit from it.||
2519|067|H|To help you remember, take it at the same time each day.||
2519|068|B|||
2519|069|S|SIDE EFFECTS:  See also Warning section.||
2519|070|S|   Nausea, vomiting, diarrhea, abdominal pain, mouth sores,||
2519|071|S|decreased appetite, headache, or trouble sleeping may occur. If||
2519|072|S|any of these effects last or get worse, tell your doctor or||
2519|073|S|pharmacist promptly.||
2519|074|S|   Remember that this medication has been prescribed because your||
2519|075|S|doctor has judged that the benefit to you is greater than the||
2519|076|S|risk of side effects. Many people using this medication do not||
2519|077|S|have serious side effects.||
2519|078|S|   Tell your doctor right away if you have any serious side||
2519|079|S|effects, including: unusual tiredness, pale skin, easy||
2519|080|S|bruising/bleeding.||
2519|081|S|   This medication may lower your ability to fight infections.||
2519|082|S|This may make you more likely to get a serious (rarely fatal)||
2519|083|S|infection or make any infection you have worse. Tell your doctor||
2519|084|S|right away if you have any signs of infection (such as sore||
2519|085|S|throat that doesn't go away, fever, chills).||
2519|086|S|   A very serious allergic reaction to this drug is rare.||
2519|087|S|However, get medical help right away if you notice any symptoms||
2519|088|S|of a serious allergic reaction, including: rash, itching/swelling||
2519|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2519|090|S|breathing.||
2519|091|S|   This is not a complete list of possible side effects. If you||
2519|092|S|notice other effects not listed above, contact your doctor or||
2519|093|S|pharmacist.||
2519|094|S|   In the US -||
2519|095|S|   Call your doctor for medical advice about side effects. You||
2519|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2519|097|S|www.fda.gov/medwatch.||
2519|098|S|   In Canada - Call your doctor for medical advice about side||
2519|099|S|effects. You may report side effects to Health Canada at||
2519|100|S|1-866-234-2345.||
2519|101|B|||
2519|102|P|PRECAUTIONS:  See also Warning section.||
2519|103|P|   Before taking quizartinib, tell your doctor or pharmacist if||
2519|104|P|you are allergic to it; or if you have any other allergies. This||
2519|105|P|product may contain inactive ingredients, which can cause||
2519|106|P|allergic reactions or other problems. Talk to your pharmacist for||
2519|107|P|more details.||
2519|108|P|   Before using this medication, tell your doctor or pharmacist||
2519|109|P|your medical history.||
2519|110|P|   Quizartinib can make you more likely to get infections or may||
2519|111|P|make current infections worse. Stay away from anyone who has an||
2519|112|P|infection that may easily spread (such as chickenpox, COVID-19,||
2519|113|P|measles, flu). Talk to your doctor if you have been exposed to an||
2519|114|P|infection or for more details.||
2519|115|P|   Tell your health care professional that you are using||
2519|116|P|quizartinib before having any immunizations/vaccinations. Avoid||
2519|117|P|contact with people who have recently received live vaccines||
2519|118|P|(such as flu vaccine inhaled through the nose).||
2519|119|P|   To lower the chance of getting cut, bruised, or injured, use||
2519|120|P|caution with sharp objects like razors and nail cutters, and||
2519|121|P|avoid activities such as contact sports.||
2519|122|P|   Before having surgery, tell your doctor or dentist about all||
2519|123|P|the products you use (including prescription drugs,||
2519|124|P|nonprescription drugs, and herbal products).||
2519|125|P|   Older adults may be more sensitive to the side effects of this||
2519|126|P|drug, especially QT prolongation. See also Warning section.||
2519|127|P|   Tell your doctor if you are pregnant or plan to become||
2519|128|P|pregnant. You should not become pregnant while using quizartinib.||
2519|129|P|Quizartinib may harm an unborn baby. Women using this medication||
2519|130|P|should ask about reliable forms of birth control during treatment||
2519|131|P|and for 7 months after the last dose. Men using this medication||
2519|132|P|should ask about reliable forms of birth control during treatment||
2519|133|P|and for 4 months after the last dose. If you or your partner||
2519|134|P|becomes pregnant, talk to your doctor right away about the risks||
2519|135|P|and benefits of this medication.||
2519|136|P|   It is unknown if this medication passes into breast milk.||
2519|137|P|Because of the possible risk to the infant, breastfeeding is not||
2519|138|P|recommended while using this medication and for 1 month after the||
2519|139|P|last dose. Consult your doctor before breastfeeding.||
2519|140|B|||
2519|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2519|142|I|medications work or increase your risk for serious side effects.||
2519|143|I|This document does not contain all possible drug interactions.||
2519|144|I|Keep a list of all the products you use (including||
2519|145|I|prescription/nonprescription drugs and herbal products) and share||
2519|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
2519|147|I|the dosage of any medicines without your doctor's approval.||
2519|148|I|   Other medications can affect the removal of quizartinib from||
2519|149|I|your body, which may affect how quizartinib works. Examples||
2519|150|I|include apalutamide, bosentan, enzalutamide, levoketoconazole,||
2519|151|I|lumacaftor, mitotane, nafcillin, rifamycins (such as rifampin,||
2519|152|I|rifapentine), St. John's wort, drugs used to treat seizures (such||
2519|153|I|as carbamazepine, phenytoin), among others.||
2519|154|B|||
2519|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2519|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2519|157|O|poison control center right away. US residents can call||
2519|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2519|159|B|||
2519|160|N|NOTES:  Do not share this medication with others.||
2519|161|N|   Lab and/or medical tests (such as kidney/liver function, blood||
2519|162|N|mineral levels, EKG) should be done before you start taking this||
2519|163|N|medication and while you are taking it. Keep all medical and lab||
2519|164|N|appointments. Consult your doctor for more details.||
2519|165|B|||
2519|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2519|167|D|remember. If it is near the time of the next dose, skip the||
2519|168|D|missed dose. Take your next dose at the regular time. Do not||
2519|169|D|double the dose to catch up.||
2519|170|B|||
2519|171|R|STORAGE:  Store at room temperature away from light and moisture.||
2519|172|R|Do not store in the bathroom. Keep all medications away from||
2519|173|R|children and pets.||
2519|174|R|   Do not flush medications down the toilet or pour them into a||
2519|175|R|drain unless instructed to do so. Properly discard this product||
2519|176|R|when it is expired or no longer needed. Consult your pharmacist||
2519|177|R|or local waste disposal company.||
2519|178|B|||
2519|179|A|Information last revised April 2025.||
2519|180|A|Copyright(c) 2025 First Databank, Inc.||
2519|181|B|||
2520|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2520|002|Z|does NOT have all possible information about this product. This||
2520|003|Z|information does not assure that this product is safe, effective,||
2520|004|Z|or appropriate for you. This information is not individual||
2520|005|Z|medical advice and does not substitute for the advice of your||
2520|006|Z|health care professional. Always ask your health care||
2520|007|Z|professional for complete information about this product and your||
2520|008|Z|specific health needs.||
2520|009|B|||
2520|010|T|CANTHARIDIN - TOPICAL||
2520|011|F|(kan-THAR-i-din)||
2520|012|B|||
2520|013|C|COMMON BRAND NAME(S): Ycanth||
2520|014|B|||
2520|015|U|USES:  This medication is used to treat a certain viral skin||
2520|016|U|infection (molluscum contagiosum).||
2520|017|B|||
2520|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2520|019|H|from your pharmacist before you start using cantharidin and each||
2520|020|H|time you get a refill. If you have any questions, ask your doctor||
2520|021|H|or pharmacist.||
2520|022|H|   This medication is for use on the skin only. It is applied to||
2520|023|H|the affected area by a healthcare professional as directed by||
2520|024|H|your doctor, usually every 3 weeks as needed. It should not be||
2520|025|H|applied inside the nose, mouth, or vagina, or in or near the||
2520|026|H|eyes. The treated area should not be covered with bandages. After||
2520|027|H|the medication is applied, do not touch, bite, or lick the||
2520|028|H|treated area. Make sure the treated areas of the skin do not come||
2520|029|H|in contact with the mouth, nose, eyes, or genital areas. If you||
2520|030|H|do get the medication in those areas, rinse with plenty of water||
2520|031|H|and get medical help right away.||
2520|032|H|   This medication is flammable until dry. Avoid smoking or being||
2520|033|H|near open flames while using the medication and until the||
2520|034|H|medication has dried.||
2520|035|H|   The medication should be washed off with soap and water as||
2520|036|H|directed by your doctor, usually 24 hours after treatment. It may||
2520|037|H|be washed off earlier if severe pain or blistering occurs on the||
2520|038|H|treated area. Ask your doctor for more details.||
2520|039|H|   Avoid applying other products to the treated areas of the skin||
2520|040|H|until at least 24 hours after the treatment or until the treated||
2520|041|H|area is washed off.||
2520|042|H|   Tell your doctor if your condition does not get better or if||
2520|043|H|it gets worse.||
2520|044|B|||
2520|045|S|SIDE EFFECTS:  Blistering, pain, itching, swelling, or change in||
2520|046|S|skin color may occur at the treated area. If any of these effects||
2520|047|S|last or get worse, tell your doctor or pharmacist promptly.||
2520|048|S|   Remember that this medication has been prescribed because your||
2520|049|S|doctor has judged that the benefit to you is greater than the||
2520|050|S|risk of side effects. Many people using this medication do not||
2520|051|S|have serious side effects.||
2520|052|S|   Tell your doctor right away if you have any serious side||
2520|053|S|effects, including: severe pain/blistering/swelling at the||
2520|054|S|treated area.||
2520|055|S|   A very serious allergic reaction to this drug is rare.||
2520|056|S|However, get medical help right away if you notice any symptoms||
2520|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2520|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2520|059|S|breathing.||
2520|060|S|   This is not a complete list of possible side effects. If you||
2520|061|S|notice other effects not listed above, contact your doctor or||
2520|062|S|pharmacist.||
2520|063|S|   In the US -||
2520|064|S|   Call your doctor for medical advice about side effects. You||
2520|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2520|066|S|www.fda.gov/medwatch.||
2520|067|S|   In Canada - Call your doctor for medical advice about side||
2520|068|S|effects. You may report side effects to Health Canada at||
2520|069|S|1-866-234-2345.||
2520|070|B|||
2520|071|P|PRECAUTIONS:  Before using cantharidin, tell your doctor or||
2520|072|P|pharmacist if you are allergic to it; or if you have any other||
2520|073|P|allergies. This product may contain inactive ingredients, which||
2520|074|P|can cause allergic reactions or other problems. Talk to your||
2520|075|P|pharmacist for more details.||
2520|076|P|   Before using this medication, tell your doctor or pharmacist||
2520|077|P|your medical history.||
2520|078|P|   Before having surgery, tell your doctor or dentist about all||
2520|079|P|the products you use (including prescription drugs,||
2520|080|P|nonprescription drugs, and herbal products).||
2520|081|P|   During pregnancy, this medication should be used only when||
2520|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
2520|083|P|   It is unknown if this drug passes into breast milk. Consult||
2520|084|P|your doctor before breastfeeding.||
2520|085|B|||
2520|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2520|087|I|medications work or increase your risk for serious side effects.||
2520|088|I|This document does not contain all possible drug interactions.||
2520|089|I|Keep a list of all the products you use (including||
2520|090|I|prescription/nonprescription drugs and herbal products) and share||
2520|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2520|092|I|the dosage of any medicines without your doctor's approval.||
2520|093|B|||
2520|094|O|OVERDOSE:  This medicine may be harmful, possibly fatal, if||
2520|095|O|swallowed. If someone has overdosed and has serious symptoms such||
2520|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2520|097|O|poison control center right away. US residents can call||
2520|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2520|099|O|Symptoms of overdose or swallowing may include: severe||
2520|100|O|stomach/abdominal pain, seizures, weakness, unusual||
2520|101|O|bleeding/bruising, change in the amount of urine.||
2520|102|B|||
2520|103|N|NOTES:  Keep all medical and lab appointments.||
2520|104|B|||
2520|105|D|MISSED DOSE:  Not applicable.||
2520|106|B|||
2520|107|R|STORAGE:  Not applicable. This medication is applied in a clinic||
2520|108|R|or doctor's office and will not be stored at home.||
2520|109|B|||
2520|110|A|Information last revised July 2025.||
2520|111|A|Copyright(c) 2025 First Databank, Inc.||
2520|112|B|||
2521|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2521|002|Z|does NOT have all possible information about this product. This||
2521|003|Z|information does not assure that this product is safe, effective,||
2521|004|Z|or appropriate for you. This information is not individual||
2521|005|Z|medical advice and does not substitute for the advice of your||
2521|006|Z|health care professional. Always ask your health care||
2521|007|Z|professional for complete information about this product and your||
2521|008|Z|specific health needs.||
2521|009|B|||
2521|010|T|VALOCTOCOGENE ROXAPARVOVEC - INJECTION||
2521|011|F|(val-OK-toe-KOE-jeen ROX-a-PAR-voe-vek)||
2521|012|B|||
2521|013|C|COMMON BRAND NAME(S): Roctavian||
2521|014|B|||
2521|015|U|USES:  This medication is used to treat a certain blood clotting||
2521|016|U|disease (hemophilia A). Hemophilia A is a genetic disorder caused||
2521|017|U|by lack of a certain clotting protein (factor VIII), or caused by||
2521|018|U|clotting proteins that do not work properly. Valoctocogene||
2521|019|U|roxaparvovec is known as gene therapy. It works by helping your||
2521|020|U|body make normal factor VIII. This effect may decrease bleeding||
2521|021|U|problems due to hemophilia A.||
2521|022|B|||
2521|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2521|024|H|from your pharmacist before you receive valoctocogene||
2521|025|H|roxaparvovec. If you have any questions, ask your doctor or||
2521|026|H|pharmacist.||
2521|027|H|   This medication is given by slow injection into a vein as||
2521|028|H|directed by the doctor. It is given as a one-time dose. The||
2521|029|H|dosage is based on your body weight.||
2521|030|H|   Infusion reactions may happen during the infusion and for some||
2521|031|H|time afterward. Tell your doctor right away if you have any||
2521|032|H|symptoms of infusion reactions such as runny nose, coughing,||
2521|033|H|lightheadedness, fever, chills, shivering, nausea, diarrhea,||
2521|034|H|itching, or trouble breathing. Your doctor may give you other||
2521|035|H|medications to help with these side effects or may slow down or||
2521|036|H|stop your treatment for some time.||
2521|037|B|||
2521|038|S|SIDE EFFECTS:  See also How to Use section.||
2521|039|S|   Nausea, tiredness, headache, or vomiting may occur. If any of||
2521|040|S|these effects last or get worse, tell your doctor or pharmacist||
2521|041|S|promptly.||
2521|042|S|   Remember that this medication has been prescribed because your||
2521|043|S|doctor has judged that the benefit to you is greater than the||
2521|044|S|risk of side effects. Many people using this medication do not||
2521|045|S|have serious side effects.||
2521|046|S|   This medication may rarely cause serious (possibly fatal)||
2521|047|S|liver disease. Tell your doctor right away if you have any||
2521|048|S|symptoms of liver problems, such as: nausea/vomiting that doesn't||
2521|049|S|stop, loss of appetite, pain/swelling in the stomach/abdomen,||
2521|050|S|yellowing eyes/skin, dark urine.||
2521|051|S|   After receiving valoctocogene roxaparvovec, if your body makes||
2521|052|S|too much clotting protein, this may increase your risk of very||
2521|053|S|serious (possibly fatal) problems from blood clots (such as heart||
2521|054|S|attack, stroke, blood clots in the lungs or legs). Get medical||
2521|055|S|help right away if you have: shortness of breath/rapid breathing,||
2521|056|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
2521|057|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
2521|058|S|sudden/severe headaches, trouble speaking, weakness on one side||
2521|059|S|of the body, sudden vision changes.||
2521|060|S|   A very serious allergic reaction to this drug is rare.||
2521|061|S|However, get medical help right away if you notice any symptoms||
2521|062|S|of a serious allergic reaction, including: rash, itching/swelling||
2521|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2521|064|S|breathing.||
2521|065|S|   This is not a complete list of possible side effects. If you||
2521|066|S|notice other effects not listed above, contact your doctor or||
2521|067|S|pharmacist.||
2521|068|S|   In the US -||
2521|069|S|   Call your doctor for medical advice about side effects. You||
2521|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2521|071|S|www.fda.gov/medwatch.||
2521|072|S|   In Canada - Call your doctor for medical advice about side||
2521|073|S|effects. You may report side effects to Health Canada at||
2521|074|S|1-866-234-2345.||
2521|075|B|||
2521|076|P|PRECAUTIONS:  Before receiving valoctocogene roxaparvovec, tell||
2521|077|P|your doctor or pharmacist if you have any allergies. This product||
2521|078|P|may contain inactive ingredients, which can cause allergic||
2521|079|P|reactions or other problems. Talk to your pharmacist for more||
2521|080|P|details.||
2521|081|P|   Before receiving this medication, tell your doctor or||
2521|082|P|pharmacist your medical history, especially of: alcohol use,||
2521|083|P|blood clots (for example, in the legs or lungs), heart problems||
2521|084|P|(such as irregular heartbeat, previous heart attack), current||
2521|085|P|infection (such as hepatitis B or C, infection of the||
2521|086|P|nose/throat/airways), liver problems (including cirrhosis, fatty||
2521|087|P|liver disease, liver fibrosis), stroke.||
2521|088|P|   Use of alcohol after receiving this treatment may increase||
2521|089|P|your risk for liver problems. Avoid alcohol for at least 1 year||
2521|090|P|after you receive this treatment. Consult your doctor or||
2521|091|P|pharmacist for more information.||
2521|092|P|   Before having surgery, tell your doctor or dentist about all||
2521|093|P|the products you use (including prescription drugs,||
2521|094|P|nonprescription drugs, and herbal products).||
2521|095|P|   This medication is not usually used by women. It is unlikely||
2521|096|P|to be used during pregnancy or breastfeeding. Consult your doctor||
2521|097|P|if you have any questions about this medication.||
2521|098|P|   Men with female partners of childbearing age should use||
2521|099|P|reliable forms of birth control for 6 months after treatment. If||
2521|100|P|your partner becomes pregnant or thinks she may be pregnant, tell||
2521|101|P|the doctor right away. Do not donate sperm for 6 months after||
2521|102|P|treatment.||
2521|103|B|||
2521|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2521|105|I|medications work or increase your risk for serious side effects.||
2521|106|I|This document does not contain all possible drug interactions.||
2521|107|I|Keep a list of all the products you use (including||
2521|108|I|prescription/nonprescription drugs and herbal products) and share||
2521|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
2521|110|I|the dosage of any medicines without your doctor's approval.||
2521|111|B|||
2521|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2521|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2521|114|O|poison control center right away. US residents can call||
2521|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2521|116|B|||
2521|117|N|NOTES:  Lab and/or medical tests (such as liver function, factor||
2521|118|N|VIII activity and inhibitor levels) must be done before you start||
2521|119|N|receiving this treatment and after you receive it. Keep all||
2521|120|N|medical and lab appointments. Consult your doctor for more||
2521|121|N|details.||
2521|122|N|   After receiving this treatment, do not donate blood, organs,||
2521|123|N|tissues, or cells.||
2521|124|B|||
2521|125|D|MISSED DOSE:  Not applicable.||
2521|126|B|||
2521|127|R|STORAGE:  Not applicable. This type of product is given in a||
2521|128|R|hospital or clinic and will not be stored at home.||
2521|129|B|||
2521|130|M|MEDICAL ALERT:  Your condition can cause complications in a||
2521|131|M|medical emergency. For information about enrolling in MedicAlert,||
2521|132|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2521|133|B|||
2521|134|A|Information last revised May 2024.||
2521|135|A|Copyright(c) 2025 First Databank, Inc.||
2521|136|B|||
2522|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2522|002|Z|does NOT have all possible information about this product. This||
2522|003|Z|information does not assure that this product is safe, effective,||
2522|004|Z|or appropriate for you. This information is not individual||
2522|005|Z|medical advice and does not substitute for the advice of your||
2522|006|Z|health care professional. Always ask your health care||
2522|007|Z|professional for complete information about this product and your||
2522|008|Z|specific health needs.||
2522|009|B|||
2522|010|T|LOTILANER - OPHTHALMIC||
2522|011|F|(LOE-ti-LAN-er)||
2522|012|B|||
2522|013|C|COMMON BRAND NAME(S): Xdemvy||
2522|014|B|||
2522|015|U|USES:  This medication is used to treat a parasitic infection of||
2522|016|U|the eye (Demodex blepharitis) that can especially affect the||
2522|017|U|eyelids. It belongs to a class of drugs known as antiparasitics.||
2522|018|U|Lotilaner works by killing parasites.||
2522|019|U|   This medication treats only parasitic eye infections. It will||
2522|020|U|not work for other types of eye infections.||
2522|021|B|||
2522|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
2522|023|H|directed by your doctor, usually twice a day (about 12 hours||
2522|024|H|apart).||
2522|025|H|   To apply eye drops, wash hands first. To avoid contamination,||
2522|026|H|do not touch the dropper tip or let it touch your eye or any||
2522|027|H|other surface.||
2522|028|H|   If you are wearing contact lenses, remove them before using||
2522|029|H|eye drops. Wait at least 15 minutes before replacing your contact||
2522|030|H|lenses. Tilt your head back, look upward, and pull down the lower||
2522|031|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2522|032|H|and place one drop into the pouch. Look downward, gently close||
2522|033|H|your eyes, and place one finger at the corner of your eye (near||
2522|034|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2522|035|H|opening your eyes. This will prevent the medication from draining||
2522|036|H|out. Try not to blink or rub your eye. If directed to use this||
2522|037|H|medication in both eyes, repeat these steps for your other eye.||
2522|038|H|Do not rinse the dropper. Replace the dropper cap after each use.||
2522|039|H|   If you are using another kind of eye medication (such as drops||
2522|040|H|or ointments), wait at least 5 minutes before applying other||
2522|041|H|medications. Use eye drops before eye ointments to allow the||
2522|042|H|drops to enter the eye.||
2522|043|H|   Wait several minutes for your vision to clear before driving||
2522|044|H|or operating machinery.||
2522|045|H|   Use this medication regularly to get the most benefit from it.||
2522|046|H|To help you remember, use it at the same times each day. Continue||
2522|047|H|to use this medication for the full time prescribed, even if||
2522|048|H|symptoms disappear after a few days. Stopping the medication too||
2522|049|H|early may result in a return of the infection.||
2522|050|H|   Tell your doctor if your condition lasts or gets worse.||
2522|051|B|||
2522|052|S|SIDE EFFECTS:  Eye discomfort, stinging, or burning may occur. If||
2522|053|S|this effect lasts or gets worse, tell your doctor or pharmacist||
2522|054|S|promptly.||
2522|055|S|   Remember that this medication has been prescribed because your||
2522|056|S|doctor has judged that the benefit to you is greater than the||
2522|057|S|risk of side effects. Many people using this medication do not||
2522|058|S|have serious side effects.||
2522|059|S|   A very serious allergic reaction to this drug is rare.||
2522|060|S|However, get medical help right away if you notice any symptoms||
2522|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2522|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2522|063|S|breathing.||
2522|064|S|   This is not a complete list of possible side effects. If you||
2522|065|S|notice other effects not listed above, contact your doctor or||
2522|066|S|pharmacist.||
2522|067|S|   In the US -||
2522|068|S|   Call your doctor for medical advice about side effects. You||
2522|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2522|070|S|www.fda.gov/medwatch.||
2522|071|S|   In Canada - Call your doctor for medical advice about side||
2522|072|S|effects. You may report side effects to Health Canada at||
2522|073|S|1-866-234-2345.||
2522|074|B|||
2522|075|P|PRECAUTIONS:  Before using lotilaner, tell your doctor or||
2522|076|P|pharmacist if you are allergic to it; or if you have any other||
2522|077|P|allergies. This product may contain inactive ingredients, which||
2522|078|P|can cause allergic reactions or other problems. Talk to your||
2522|079|P|pharmacist for more details.||
2522|080|P|   Before using this medication, tell your doctor or pharmacist||
2522|081|P|your medical history.||
2522|082|P|   If you develop another eye infection or injury, or have eye||
2522|083|P|surgery, ask your doctor if you should continue to use this||
2522|084|P|medication.||
2522|085|P|   After you apply this drug, your vision may become temporarily||
2522|086|P|blurred. Do not drive, use machinery, or do anything that needs||
2522|087|P|clear vision until you can do it safely.||
2522|088|P|   Before having surgery, tell your doctor or dentist about all||
2522|089|P|the products you use (including prescription drugs,||
2522|090|P|nonprescription drugs, and herbal products).||
2522|091|P|   During pregnancy, this medication should be used only when||
2522|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
2522|093|P|   It is unknown if this drug passes into breast milk. Consult||
2522|094|P|your doctor before breastfeeding.||
2522|095|B|||
2522|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2522|097|I|medications work or increase your risk for serious side effects.||
2522|098|I|This document does not contain all possible drug interactions.||
2522|099|I|Keep a list of all the products you use (including||
2522|100|I|prescription/nonprescription drugs and herbal products) and share||
2522|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
2522|102|I|the dosage of any medicines without your doctor's approval.||
2522|103|B|||
2522|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2522|105|O|has overdosed and has serious symptoms such as passing out or||
2522|106|O|trouble breathing, call 911. Otherwise, call a poison control||
2522|107|O|center right away. US residents can call 1-800-222-1222. Canada||
2522|108|O|residents can call 1-844-764-7669.||
2522|109|B|||
2522|110|N|NOTES:  Do not share this medication with others.||
2522|111|N|   This medication has been prescribed for your current condition||
2522|112|N|only. Do not use it later for another infection unless your||
2522|113|N|doctor tells you to.||
2522|114|B|||
2522|115|D|MISSED DOSE:  If you miss a dose, use your next dose at the||
2522|116|D|regular time. Do not double the dose to catch up.||
2522|117|B|||
2522|118|R|STORAGE:  Store at room temperature. Keep all medications away||
2522|119|R|from children and pets.||
2522|120|R|   Do not flush medications down the toilet or pour them into a||
2522|121|R|drain unless instructed to do so. Properly discard this product||
2522|122|R|when it is expired or no longer needed. Consult your pharmacist||
2522|123|R|or local waste disposal company.||
2522|124|B|||
2522|125|A|Information last revised November 2024.||
2522|126|A|Copyright(c) 2025 First Databank, Inc.||
2522|127|B|||
2523|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2523|002|Z|does NOT have all possible information about this product. This||
2523|003|Z|information does not assure that this product is safe, effective,||
2523|004|Z|or appropriate for you. This information is not individual||
2523|005|Z|medical advice and does not substitute for the advice of your||
2523|006|Z|health care professional. Always ask your health care||
2523|007|Z|professional for complete information about this product and your||
2523|008|Z|specific health needs.||
2523|009|B|||
2523|010|T|NIRSEVIMAB - INJECTION||
2523|011|F|(nir-SEV-i-mab)||
2523|012|B|||
2523|013|C|COMMON BRAND NAME(S): Beyfortus||
2523|014|B|||
2523|015|U|USES:  Nirsevimab is used by infants and certain young children||
2523|016|U|to prevent serious lung infections (such as pneumonia) that are||
2523|017|U|caused the respiratory syncytial virus (RSV). Nirsevimab belongs||
2523|018|U|to a class of drugs known as monoclonal antibodies. It works by||
2523|019|U|preventing the growth of the virus.||
2523|020|B|||
2523|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2523|022|H|from the health care professional before your child receives||
2523|023|H|nirsevimab. If you have any questions, ask the doctor or||
2523|024|H|pharmacist.||
2523|025|H|   This medication is given by injection into a muscle by a||
2523|026|H|health care professional. It is usually given in the upper thigh.||
2523|027|H|It is given as directed by your child's doctor, usually as a||
2523|028|H|single dose before or during the child's first RSV season. The||
2523|029|H|dosage is based on your child's weight.||
2523|030|H|   Some children may need another dose of nirsevimab to get the||
2523|031|H|best protection. Closely follow the treatment schedule provided||
2523|032|H|by the doctor.||
2523|033|B|||
2523|034|S|SIDE EFFECTS:  Pain, redness, or swelling at the injection site||
2523|035|S|may occur. If any of these effects last or get worse, tell the||
2523|036|S|doctor or pharmacist promptly.||
2523|037|S|   Remember that this medication has been prescribed because the||
2523|038|S|doctor has judged that the benefit to your child is greater than||
2523|039|S|the risk of side effects. Many people using this medication do||
2523|040|S|not have serious side effects.||
2523|041|S|   A very serious allergic reaction to this drug is rare.||
2523|042|S|However, get medical help right away if you notice any symptoms||
2523|043|S|of a serious allergic reaction, including: bluish skin/lips,||
2523|044|S|muscle weakness, rash, itching/swelling (especially of the||
2523|045|S|face/tongue/throat), severe dizziness, trouble breathing.||
2523|046|S|   This is not a complete list of possible side effects. If you||
2523|047|S|notice other effects not listed above, contact your doctor or||
2523|048|S|pharmacist.||
2523|049|S|   In the US -||
2523|050|S|   Call your doctor for medical advice about side effects. You||
2523|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2523|052|S|www.fda.gov/medwatch.||
2523|053|S|   In Canada - Call your doctor for medical advice about side||
2523|054|S|effects. You may report side effects to Health Canada at||
2523|055|S|1-866-234-2345.||
2523|056|B|||
2523|057|P|PRECAUTIONS:  Before receiving nirsevimab, tell the doctor or||
2523|058|P|pharmacist if your child is allergic to it; or if your child has||
2523|059|P|any other allergies. This product may contain inactive||
2523|060|P|ingredients, which can cause allergic reactions or other||
2523|061|P|problems. Talk to the pharmacist for more details.||
2523|062|P|   Before receiving this medication, tell the doctor or||
2523|063|P|pharmacist your child's medical history, especially of:||
2523|064|P|bleeding/blood clotting problems (such as low platelets,||
2523|065|P|coagulation disorder).||
2523|066|P|   Before having surgery (especially certain heart procedures),||
2523|067|P|tell the doctor or dentist about this medication and all the||
2523|068|P|products your child uses (including prescription drugs,||
2523|069|P|nonprescription drugs, and herbal products).||
2523|070|P|   This medication is not usually used by adults. It is unlikely||
2523|071|P|to be used during pregnancy or breastfeeding. Consult the doctor||
2523|072|P|if you have any questions about this medication.||
2523|073|B|||
2523|074|I|DRUG INTERACTIONS:  Drug interactions may change how your child's||
2523|075|I|medications work or increase the risk for serious side effects.||
2523|076|I|This document does not contain all possible drug interactions.||
2523|077|I|Keep a list of all the products your child uses (including||
2523|078|I|prescription/nonprescription drugs and herbal products) and share||
2523|079|I|it with the doctor and pharmacist. Do not start, stop, or change||
2523|080|I|the dosage of any medicines without the doctor's approval.||
2523|081|B|||
2523|082|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2523|083|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2523|084|O|poison control center right away. US residents can call||
2523|085|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2523|086|B|||
2523|087|N|NOTES:  Keep all medical and lab appointments.||
2523|088|B|||
2523|089|D|MISSED DOSE:  Not applicable.||
2523|090|B|||
2523|091|R|STORAGE:  Not applicable. This medication is given in a hospital||
2523|092|R|or clinic and will not be stored at home.||
2523|093|B|||
2523|094|A|Information last revised June 2025.||
2523|095|A|Copyright(c) 2025 First Databank, Inc.||
2523|096|B|||
2524|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2524|002|Z|does NOT have all possible information about this product. This||
2524|003|Z|information does not assure that this product is safe, effective,||
2524|004|Z|or appropriate for you. This information is not individual||
2524|005|Z|medical advice and does not substitute for the advice of your||
2524|006|Z|health care professional. Always ask your health care||
2524|007|Z|professional for complete information about this product and your||
2524|008|Z|specific health needs.||
2524|009|B|||
2524|010|T|SULBACTAM/DURLOBACTAM - INJECTION||
2524|011|B|||
2524|012|C|COMMON BRAND NAME(S): Xacduro||
2524|013|B|||
2524|014|U|USES:  This medication is used to treat certain bacterial||
2524|015|U|infections. This product contains 2 medications: sulbactam and||
2524|016|U|durlobactam. Sulbactam is an antibiotic that works by stopping||
2524|017|U|the growth of bacteria. Durlobactam is an enzyme inhibitor||
2524|018|U|(beta-lactamase inhibitor) that helps sulbactam work better.||
2524|019|B|||
2524|020|H|HOW TO USE:  This medication is given by injection into a vein as||
2524|021|H|directed by your doctor, usually every 6 hours. It is injected||
2524|022|H|slowly into the vein over 3 hours. The dosage and length of||
2524|023|H|treatment is based on your medical condition and response to||
2524|024|H|treatment.||
2524|025|H|   If you are using this medication at home, learn all||
2524|026|H|preparation and usage instructions from your health care||
2524|027|H|professional. Read the Instructions for Use leaflet if available||
2524|028|H|from your pharmacist before you start using this product. Before||
2524|029|H|using, check this product for particles or discoloration. If||
2524|030|H|either is present, do not use the liquid. Learn how to store and||
2524|031|H|discard medical supplies safely.||
2524|032|H|   For the best effect, use this antibiotic at evenly spaced||
2524|033|H|times. To help you remember, use this medication at the same||
2524|034|H|times every day.||
2524|035|H|   Continue to use this medication until the full prescribed||
2524|036|H|amount is finished, even if symptoms disappear after a few days.||
2524|037|H|Stopping the medication too early may result in a return of the||
2524|038|H|infection.||
2524|039|H|   Tell your doctor if your condition lasts or gets worse.||
2524|040|B|||
2524|041|S|SIDE EFFECTS:  Diarrhea may occur. If this effect lasts or gets||
2524|042|S|worse, tell your doctor or pharmacist promptly.||
2524|043|S|   Remember that this medication has been prescribed because your||
2524|044|S|doctor has judged that the benefit to you is greater than the||
2524|045|S|risk of side effects. Many people using this medication do not||
2524|046|S|have serious side effects.||
2524|047|S|   Tell your doctor right away if you have any serious side||
2524|048|S|effects, including: muscle cramps, irregular/fast heartbeat,||
2524|049|S|signs of anemia (such as unusual tiredness, pale skin, rapid||
2524|050|S|breathing), signs of liver disease (such as nausea/vomiting that||
2524|051|S|doesn't stop, loss of appetite, yellowing eyes/skin, dark urine).||
2524|052|S|   This medication may rarely cause a severe intestinal condition||
2524|053|S|due to a bacteria called C. difficile. This condition may occur||
2524|054|S|during treatment or weeks to months after treatment has stopped.||
2524|055|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2524|056|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2524|057|S|stool.||
2524|058|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2524|059|S|products because they may make symptoms worse.||
2524|060|S|   This medication may sometimes cause oral thrush or a new yeast||
2524|061|S|infection. Contact your doctor if you notice white patches in||
2524|062|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2524|063|S|   A very serious allergic reaction to this drug is rare.||
2524|064|S|However, get medical help right away if you notice any symptoms||
2524|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2524|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2524|067|S|breathing.||
2524|068|S|   This is not a complete list of possible side effects. If you||
2524|069|S|notice other effects not listed above, contact your doctor or||
2524|070|S|pharmacist.||
2524|071|S|   In the US -||
2524|072|S|   Call your doctor for medical advice about side effects. You||
2524|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2524|074|S|www.fda.gov/medwatch.||
2524|075|S|   In Canada - Call your doctor for medical advice about side||
2524|076|S|effects. You may report side effects to Health Canada at||
2524|077|S|1-866-234-2345.||
2524|078|B|||
2524|079|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2524|080|P|pharmacist if you are allergic to sulbactam or durlobactam; or to||
2524|081|P|penicillins, cephalosporins, or other beta-lactam antibiotics; or||
2524|082|P|to other beta-lactamase inhibitors (such as avibactam); or if you||
2524|083|P|have any other allergies. This product may contain inactive||
2524|084|P|ingredients, which can cause allergic reactions or other||
2524|085|P|problems. Talk to your pharmacist for more details.||
2524|086|P|   Before using this medication, tell your doctor or pharmacist||
2524|087|P|your medical history, especially of: kidney disease.||
2524|088|P|   Durlobactam/sulbactam may cause live bacterial vaccines (such||
2524|089|P|as typhoid vaccine) to not work well. Tell your health care||
2524|090|P|professional that you are using this medication before having any||
2524|091|P|immunizations/vaccinations.||
2524|092|P|   Before having surgery, tell your doctor or dentist about all||
2524|093|P|the products you use (including prescription drugs,||
2524|094|P|nonprescription drugs, and herbal products).||
2524|095|P|   During pregnancy, this medication should be used only when||
2524|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
2524|097|P|   Sulbactam passes into breast milk. It is unknown if||
2524|098|P|durlobactam passes into breast milk. Consult your doctor before||
2524|099|P|breastfeeding.||
2524|100|B|||
2524|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2524|102|I|medications work or increase your risk for serious side effects.||
2524|103|I|This document does not contain all possible drug interactions.||
2524|104|I|Keep a list of all the products you use (including||
2524|105|I|prescription/nonprescription drugs and herbal products) and share||
2524|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
2524|107|I|the dosage of any medicines without your doctor's approval.||
2524|108|B|||
2524|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2524|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2524|111|O|poison control center right away. US residents can call||
2524|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2524|113|O|Symptoms of overdose may include: seizures.||
2524|114|B|||
2524|115|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
2524|116|N|complete blood count) may be done while you are using this||
2524|117|N|medication. Keep all medical and lab appointments. Consult your||
2524|118|N|doctor for more details.||
2524|119|B|||
2524|120|D|MISSED DOSE:  It is important to get each dose of this medication||
2524|121|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2524|122|D|right away for a new dosing schedule. Do not double the dose to||
2524|123|D|catch up.||
2524|124|B|||
2524|125|R|STORAGE:  Consult the product instructions and your pharmacist||
2524|126|R|for storage details. Keep all medications away from children and||
2524|127|R|pets.||
2524|128|R|   Do not flush medications down the toilet or pour them into a||
2524|129|R|drain unless instructed to do so. Properly discard this product||
2524|130|R|when it is expired or no longer needed. Consult your pharmacist||
2524|131|R|or local waste disposal company.||
2524|132|B|||
2524|133|A|Information last revised December 2024.||
2524|134|A|Copyright(c) 2025 First Databank, Inc.||
2524|135|B|||
2525|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2525|002|Z|does NOT have all possible information about this product. This||
2525|003|Z|information does not assure that this product is safe, effective,||
2525|004|Z|or appropriate for you. This information is not individual||
2525|005|Z|medical advice and does not substitute for the advice of your||
2525|006|Z|health care professional. Always ask your health care||
2525|007|Z|professional for complete information about this product and your||
2525|008|Z|specific health needs.||
2525|009|B|||
2525|010|T|BEXAGLIFLOZIN - ORAL||
2525|011|F|(BEX-a-gli-FLOE-zin)||
2525|012|B|||
2525|013|C|COMMON BRAND NAME(S): Brenzavvy||
2525|014|B|||
2525|015|U|USES:  Bexagliflozin is used with a proper diet and exercise||
2525|016|U|program to control high blood sugar in people with type 2||
2525|017|U|diabetes. Controlling high blood sugar helps prevent kidney||
2525|018|U|damage, blindness, nerve problems, loss of limbs, and sexual||
2525|019|U|function problems. Proper control of diabetes may also lessen||
2525|020|U|your risk of a heart attack or stroke. Bexagliflozin works by||
2525|021|U|increasing the removal of sugar by your kidneys.||
2525|022|B|||
2525|023|H|HOW TO USE:  Read the Medication Guide provided by your||
2525|024|H|pharmacist before you start taking bexagliflozin and each time||
2525|025|H|you get a refill. If you have any questions, ask your doctor or||
2525|026|H|pharmacist.||
2525|027|H|   Take this medication by mouth with or without food as directed||
2525|028|H|by your doctor, usually once daily in the morning. Do not crush||
2525|029|H|or chew the tablet.||
2525|030|H|   Use this medication regularly to get the most benefit from it.||
2525|031|H|To help you remember, take it at the same time each day.||
2525|032|H|   Tell your doctor if your condition does not get better or if||
2525|033|H|it gets worse (your blood sugar is too high or too low).||
2525|034|B|||
2525|035|S|SIDE EFFECTS:  Frequent urination, dizziness, or lightheadedness||
2525|036|S|may occur. If any of these effects last or get worse, tell your||
2525|037|S|doctor or pharmacist promptly.||
2525|038|S|   To reduce the risk of dizziness and lightheadedness, get up||
2525|039|S|slowly when rising from a sitting or lying position.||
2525|040|S|   Remember that this medication has been prescribed because your||
2525|041|S|doctor has judged that the benefit to you is greater than the||
2525|042|S|risk of side effects. Many people using this medication do not||
2525|043|S|have serious side effects.||
2525|044|S|   Tell your doctor right away if you have any serious side||
2525|045|S|effects, including: signs of a urinary tract infection (such as||
2525|046|S|burning/painful/frequent/urgent urination, pink/bloody urine),||
2525|047|S|signs of kidney problems (such as change in the amount of urine,||
2525|048|S|swelling legs/feet), bone pain.||
2525|049|S|   Get medical help right away if you have any very serious side||
2525|050|S|effects, including: unusual tiredness, nausea/vomiting,||
2525|051|S|stomach/abdominal pain, trouble breathing.||
2525|052|S|   This medication may cause a new yeast infection in the vagina||
2525|053|S|or the penis. It may also cause a rare but very serious bacterial||
2525|054|S|infection in the genital/anal area (Fournier's gangrene). Tell||
2525|055|S|your doctor right away if you have signs of a yeast infection in||
2525|056|S|the vagina (such as unusual vaginal||
2525|057|S|discharge/burning/itching/odor) or in the penis (such as||
2525|058|S|redness/itching/swelling of the penis, unusual discharge from the||
2525|059|S|penis). However, get medical help right away if you have any||
2525|060|S|pain/redness/swelling in or around the genital/anal area, along||
2525|061|S|with a fever or feeling unwell.||
2525|062|S|   This medication may increase the risk of lower limb amputation||
2525|063|S|(especially of the toe and foot). The risk is higher if you have||
2525|064|S|poor blood flow in the legs, nerve problems, foot ulcers, or have||
2525|065|S|had a previous amputation. To lessen the risk, check your feet||
2525|066|S|regularly and tell your doctor if you have new pain, tenderness,||
2525|067|S|sores, or ulcers on your legs or feet.||
2525|068|S|   Bexagliflozin does not usually cause low blood sugar||
2525|069|S|(hypoglycemia). Low blood sugar may occur if this drug is||
2525|070|S|prescribed with other diabetes medications, or if you do not get||
2525|071|S|enough calories from food, or if you do unusually heavy exercise.||
2525|072|S|Talk with your doctor or pharmacist about whether the dose of||
2525|073|S|your other diabetes medication(s) needs to be lowered. Symptoms||
2525|074|S|of low blood sugar include sudden sweating, shaking, fast||
2525|075|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
2525|076|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
2525|077|S|treat low blood sugar. If you don't have these reliable forms of||
2525|078|S|glucose, rapidly raise your blood sugar by eating a quick source||
2525|079|S|of sugar such as table sugar, honey, or candy, or drink fruit||
2525|080|S|juice or non-diet soda. Tell your doctor right away about the||
2525|081|S|reaction and the use of this product. To help prevent low blood||
2525|082|S|sugar, eat meals on a regular schedule, and do not skip meals.||
2525|083|S|Check with your doctor or pharmacist to find out what you should||
2525|084|S|do if you miss a meal.||
2525|085|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
2525|086|S|thirst/urination. If these symptoms occur, tell your doctor right||
2525|087|S|away. Your doctor may need to adjust your diabetes medication,||
2525|088|S|exercise program, or diet.||
2525|089|S|   This medication may cause you to become dehydrated. This can||
2525|090|S|lead to serious kidney damage. Drink plenty of fluids to prevent||
2525|091|S|dehydration. Tell your doctor or pharmacist right away if you are||
2525|092|S|not able to drink fluids as usual, or losing fluid (such as due||
2525|093|S|to vomiting, diarrhea, or heavy sweating). Also, tell your doctor||
2525|094|S|right away if you have any signs of dehydration, such as||
2525|095|S|urinating less than usual, unusual dry mouth/thirst, fast||
2525|096|S|heartbeat, or dizziness/lightheadedness/fainting.||
2525|097|S|   A very serious allergic reaction to this drug is rare.||
2525|098|S|However, get medical help right away if you notice any symptoms||
2525|099|S|of a serious allergic reaction, including: rash, itching/swelling||
2525|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2525|101|S|breathing.||
2525|102|S|   This is not a complete list of possible side effects. If you||
2525|103|S|notice other effects not listed above, contact your doctor or||
2525|104|S|pharmacist.||
2525|105|S|   In the US -||
2525|106|S|   Call your doctor for medical advice about side effects. You||
2525|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2525|108|S|www.fda.gov/medwatch.||
2525|109|S|   In Canada - Call your doctor for medical advice about side||
2525|110|S|effects. You may report side effects to Health Canada at||
2525|111|S|1-866-234-2345.||
2525|112|B|||
2525|113|P|PRECAUTIONS:  Before taking bexagliflozin, tell your doctor or||
2525|114|P|pharmacist if you are allergic to it; or if you have any other||
2525|115|P|allergies. This product may contain inactive ingredients, which||
2525|116|P|can cause allergic reactions or other problems. Talk to your||
2525|117|P|pharmacist for more details.||
2525|118|P|   Before using this medication, tell your doctor or pharmacist||
2525|119|P|your medical history, especially of: kidney disease, liver||
2525|120|P|disease, disease of the pancreas (pancreatitis), dehydration,||
2525|121|P|use/abuse of alcohol, low blood pressure, history of yeast||
2525|122|P|infections in the vagina or penis, blocked or narrowed blood||
2525|123|P|vessels, usually in the leg, nerve problems (such as diabetic||
2525|124|P|peripheral neuropathy), foot sores or ulcers, amputation.||
2525|125|P|   You may experience blurred vision, dizziness, or drowsiness||
2525|126|P|due to extremely low or high blood sugar. Do not drive, use||
2525|127|P|machinery, or do anything that needs alertness or clear vision||
2525|128|P|until you can do it safely. Limit alcohol while taking this||
2525|129|P|medication because it can increase your risk of developing low||
2525|130|P|blood sugar and a high ketone level.||
2525|131|P|   It may be harder to control your blood sugar when your body is||
2525|132|P|stressed (such as due to fever, infection, injury, or surgery).||
2525|133|P|Also, if you are eating less or not able to eat due to these||
2525|134|P|conditions or any illness, this can lead to a high ketone level||
2525|135|P|while you are taking this medication. Consult your doctor because||
2525|136|P|this may require a change in your treatment plan, medications, or||
2525|137|P|blood sugar or ketone testing.||
2525|138|P|   Before having surgery, tell your doctor or dentist about all||
2525|139|P|the products you use (including prescription drugs,||
2525|140|P|nonprescription drugs, and herbal products).||
2525|141|P|   Older adults may be more sensitive to the side effects of this||
2525|142|P|drug, especially dizziness/fainting (usually when standing),||
2525|143|P|dehydration, and kidney disease.||
2525|144|P|   During pregnancy, this medication should be used only when||
2525|145|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2525|146|P|benefits with your doctor.||
2525|147|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
2525|148|P|your doctor for managing your blood sugar while pregnant. Your||
2525|149|P|doctor may change your diabetes treatment during your pregnancy||
2525|150|P|(such as diet and medications including insulin).||
2525|151|P|   It is unknown if this drug passes into breast milk. Consult||
2525|152|P|your doctor before breastfeeding.||
2525|153|B|||
2525|154|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2525|155|I|medications work or increase your risk for serious side effects.||
2525|156|I|This document does not contain all possible drug interactions.||
2525|157|I|Keep a list of all the products you use (including||
2525|158|I|prescription/nonprescription drugs and herbal products) and share||
2525|159|I|it with your doctor and pharmacist. Do not start, stop, or change||
2525|160|I|the dosage of any medicines without your doctor's approval.||
2525|161|I|   Beta blocker medications (such as metoprolol, propranolol,||
2525|162|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
2525|163|I|heartbeat you would usually feel when your blood sugar falls too||
2525|164|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
2525|165|I|dizziness, hunger, or sweating, are not affected by these drugs.||
2525|166|I|   Many drugs can affect your blood sugar, making it harder to||
2525|167|I|control. Before you start, stop, or change any medication, talk||
2525|168|I|with your doctor or pharmacist about how the medication may||
2525|169|I|affect your blood sugar. Check your blood sugar regularly as||
2525|170|I|directed and share the results with your doctor. Tell your doctor||
2525|171|I|right away if you have symptoms of high or low blood sugar. (See||
2525|172|I|also Side Effects section.) Your doctor may need to adjust your||
2525|173|I|diabetes medication, exercise program, or diet.||
2525|174|I|   This medication may interfere with certain lab tests (such as||
2525|175|I|urine glucose test), possibly causing false test results. Make||
2525|176|I|sure lab personnel and all your doctors know you use this drug.||
2525|177|B|||
2525|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2525|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2525|180|O|poison control center right away. US residents can call||
2525|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2525|182|B|||
2525|183|N|NOTES:  Do not share this medication with others.||
2525|184|N|   Attend a diabetes education program to learn more about how to||
2525|185|N|manage your diabetes with medications, diet, exercise, and||
2525|186|N|regular medical exams.||
2525|187|N|   Learn the symptoms of high and low blood sugar and how to||
2525|188|N|treat low blood sugar. Check your blood sugar regularly as||
2525|189|N|directed.||
2525|190|N|   Lab and/or medical tests (such as kidney function, blood||
2525|191|N|sugar, hemoglobin A1c, cholesterol, ketones) should be done||
2525|192|N|before you start taking this medication and while you are taking||
2525|193|N|it. Keep all medical and lab appointments. Consult your doctor||
2525|194|N|for more details.||
2525|195|B|||
2525|196|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2525|197|D|remember. If it is near the time of the next dose, skip the||
2525|198|D|missed dose. Take your next dose at the regular time. Do not||
2525|199|D|double the dose to catch up.||
2525|200|B|||
2525|201|R|STORAGE:  Store at room temperature away from light and moisture.||
2525|202|R|Do not store in the bathroom. Keep all medications away from||
2525|203|R|children and pets.||
2525|204|R|   Do not flush medications down the toilet or pour them into a||
2525|205|R|drain unless instructed to do so. Properly discard this product||
2525|206|R|when it is expired or no longer needed. Consult your pharmacist||
2525|207|R|or local waste disposal company.||
2525|208|B|||
2525|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
2525|210|M|medical emergency. For information about enrolling in MedicAlert,||
2525|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2525|212|B|||
2525|213|A|Information last revised May 2025.||
2525|214|A|Copyright(c) 2025 First Databank, Inc.||
2525|215|B|||
2526|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2526|002|Z|does NOT have all possible information about this product. This||
2526|003|Z|information does not assure that this product is safe, effective,||
2526|004|Z|or appropriate for you. This information is not individual||
2526|005|Z|medical advice and does not substitute for the advice of your||
2526|006|Z|health care professional. Always ask your health care||
2526|007|Z|professional for complete information about this product and your||
2526|008|Z|specific health needs.||
2526|009|B|||
2526|010|T|NALMEFENE - NASAL||
2526|011|F|(NAL-me-feen)||
2526|012|B|||
2526|013|C|COMMON BRAND NAME(S): Opvee||
2526|014|B|||
2526|015|U|USES:  Nalmefene is used for the emergency treatment of known or||
2526|016|U|suspected opioid overdose. Serious opioid overdose symptoms may||
2526|017|U|include unusual sleepiness, unusual difficulty waking up, or||
2526|018|U|breathing problems (ranging from slow/shallow breathing to no||
2526|019|U|breathing). Other symptoms of overdose may include very small||
2526|020|U|"pinpoint" pupils, slow heartbeat, or low blood pressure. If||
2526|021|U|someone has serious overdose symptoms but you are not sure if the||
2526|022|U|symptoms are due to opioid overdose, give nalmefene right away||
2526|023|U|anyway, since lasting slow/shallow breathing may cause permanent||
2526|024|U|damage to the brain or death. Since symptoms of opioid overdose||
2526|025|U|may return after treatment, be sure to get medical help right||
2526|026|U|away after giving the first dose of nalmefene.||
2526|027|U|   This medication belongs to a class of drugs known as opioid||
2526|028|U|antagonists. It works by blocking the effects of the opioid in||
2526|029|U|the brain.||
2526|030|B|||
2526|031|H|HOW TO USE:  Read the Patient Information Leaflet and||
2526|032|H|Instructions for Use provided by your pharmacist when you get||
2526|033|H|this medication and each time you get a refill. Be sure to keep||
2526|034|H|this medication handy in case it is needed. Learn ahead of time||
2526|035|H|how to properly give this medication. If you have any questions,||
2526|036|H|ask your doctor or pharmacist.||
2526|037|H|   Close family and household members should know the symptoms of||
2526|038|H|an opioid overdose and be instructed on how to give nalmefene if||
2526|039|H|needed. Opioid overdose should be treated right away to prevent||
2526|040|H|serious effects (such as brain damage). See also Uses section.||
2526|041|H|   Remove the nalmefene spray from the package only when you are||
2526|042|H|ready to use it. Lay the person on their back. Tilt the person's||
2526|043|H|head back and support their neck with your hand. Use your other||
2526|044|H|hand to gently insert the tip of the spray nozzle into one||
2526|045|H|nostril, then firmly press the plunger to give the dose. Remove||
2526|046|H|the spray nozzle from the nostril and move the person onto their||
2526|047|H|side.||
2526|048|H|   After giving nalmefene, get medical help right away, even if||
2526|049|H|the person wakes up. If symptoms return after giving the spray,||
2526|050|H|give another dose in the other nostril every 2 to 5 minutes,||
2526|051|H|changing nostrils with each dose. Each nasal spray contains only||
2526|052|H|one dose and cannot be reused. Continue to closely watch the||
2526|053|H|person until emergency help comes. Tell the health care||
2526|054|H|professional that you have given nalmefene spray.||
2526|055|B|||
2526|056|S|SIDE EFFECTS:  Nasal discomfort or stuffy nose may occur.||
2526|057|S|Headache, nausea, flushing, or dizziness may also occur. If any||
2526|058|S|of these effects last or get worse, tell your doctor or||
2526|059|S|pharmacist promptly.||
2526|060|S|   Remember that this medication has been prescribed because your||
2526|061|S|doctor has judged that the benefit to you is greater than the||
2526|062|S|risk of side effects. Many people using this medication do not||
2526|063|S|have serious side effects.||
2526|064|S|   In someone who has been using an opioid regularly, withdrawal||
2526|065|S|symptoms can happen suddenly after receiving this medication.||
2526|066|S|Withdrawal symptoms may include body aches, fever, sweating,||
2526|067|S|watering eyes, runny nose, sneezing, goose bumps, yawning,||
2526|068|S|weakness, shivering/trembling, nervousness, restlessness,||
2526|069|S|diarrhea, nausea/vomiting, stomach cramps, increased blood||
2526|070|S|pressure, or fast heartbeat.||
2526|071|S|   A very serious allergic reaction to this drug is rare.||
2526|072|S|However, get medical help right away if you notice any symptoms||
2526|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2526|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2526|075|S|breathing.||
2526|076|S|   This is not a complete list of possible side effects. If you||
2526|077|S|notice other effects not listed above, contact your doctor or||
2526|078|S|pharmacist.||
2526|079|S|   In the US -||
2526|080|S|   Call your doctor for medical advice about side effects. You||
2526|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2526|082|S|www.fda.gov/medwatch.||
2526|083|S|   In Canada - Call your doctor for medical advice about side||
2526|084|S|effects. You may report side effects to Health Canada at||
2526|085|S|1-866-234-2345.||
2526|086|B|||
2526|087|P|PRECAUTIONS:  Before using nalmefene, tell your doctor or||
2526|088|P|pharmacist if you are allergic to it; or if you have any other||
2526|089|P|allergies. This product may contain inactive ingredients, which||
2526|090|P|can cause allergic reactions or other problems. Talk to your||
2526|091|P|pharmacist for more details.||
2526|092|P|   Before using this medication, tell your doctor or pharmacist||
2526|093|P|your medical history.||
2526|094|P|   Before having surgery, tell your doctor or dentist about all||
2526|095|P|the products you use (including prescription drugs,||
2526|096|P|nonprescription drugs, and herbal products).||
2526|097|P|   Since untreated opioid overdose can harm both a pregnant woman||
2526|098|P|and her unborn baby, this medication may be used during||
2526|099|P|pregnancy. However, nalmefene may cause opioid withdrawal in your||
2526|100|P|unborn baby. Tell your doctor right away that you used this||
2526|101|P|medication, so you and your unborn baby can be monitored. Ask||
2526|102|P|your doctor for details.||
2526|103|P|   It is unknown if this medication passes into breast milk.||
2526|104|P|However, it is unlikely to harm a nursing infant. Consult your||
2526|105|P|doctor before breastfeeding.||
2526|106|B|||
2526|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2526|108|I|medications work or increase your risk for serious side effects.||
2526|109|I|This document does not contain all possible drug interactions.||
2526|110|I|Keep a list of all the products you use (including||
2526|111|I|prescription/nonprescription drugs and herbal products) and share||
2526|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2526|113|I|the dosage of any medicines without your doctor's approval.||
2526|114|B|||
2526|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2526|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2526|117|O|poison control center right away. US residents can call||
2526|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2526|119|B|||
2526|120|N|NOTES:  Ask your doctor or pharmacist about ways to prevent||
2526|121|N|opioid overdose. Teach your close family or household members the||
2526|122|N|signs and symptoms of an opioid overdose and tell them where you||
2526|123|N|keep this medication.||
2526|124|B|||
2526|125|D|MISSED DOSE:  Not applicable.||
2526|126|B|||
2526|127|R|STORAGE:  Store in the original carton at room temperature away||
2526|128|R|from light. Do not freeze. Do not open packaging until you are||
2526|129|R|ready to use the medication. From time to time, check the||
2526|130|R|expiration date and replace the medication before it expires.||
2526|131|R|Keep all medications away from children and pets.||
2526|132|R|   Do not flush medications down the toilet or pour them into a||
2526|133|R|drain unless instructed to do so. Properly discard this||
2526|134|R|medication when it is expired or no longer needed. Consult your||
2526|135|R|pharmacist or local waste disposal company.||
2526|136|B|||
2526|137|A|Information last revised September 2025.||
2526|138|A|Copyright(c) 2025 First Databank, Inc.||
2526|139|B|||
2527|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2527|002|Z|does NOT have all possible information about this product. This||
2527|003|Z|information does not assure that this product is safe, effective,||
2527|004|Z|or appropriate for you. This information is not individual||
2527|005|Z|medical advice and does not substitute for the advice of your||
2527|006|Z|health care professional. Always ask your health care||
2527|007|Z|professional for complete information about this product and your||
2527|008|Z|specific health needs.||
2527|009|B|||
2527|010|T|TALQUETAMAB - INJECTION||
2527|011|B|||
2527|012|C|COMMON BRAND NAME(S): Talvey||
2527|013|B|||
2527|014|W|WARNING:  Talquetamab may cause a certain serious (even fatal)||
2527|015|W|side effect known as cytokine release syndrome-CRS. Careful||
2527|016|W|monitoring and prompt treatment may decrease your risk. Get||
2527|017|W|medical help right away if you develop symptoms such as fever,||
2527|018|W|chills, headache, fast heartbeat, trouble breathing, or||
2527|019|W|dizziness/lightheadedness.||
2527|020|W|   This medication can also cause serious (even fatal) nervous||
2527|021|W|system problems. Tell your doctor right away if you have any||
2527|022|W|symptoms such as confusion, numbness/tingling, mental/mood||
2527|023|W|changes, drowsiness, changes in your handwriting, shaking,||
2527|024|W|trouble speaking/walking, loss of balance, seizures, or||
2527|025|W|burning/throbbing/stabbing pain.||
2527|026|W|   To receive talquetamab in the United States, you must||
2527|027|W|understand, agree to, and carefully follow the requirements of||
2527|028|W|the REMS Program for this medication. If you live in Canada or||
2527|029|W|any other country, consult your doctor and pharmacist for your||
2527|030|W|country's regulations.||
2527|031|B|||
2527|032|U|USES:  This medication is used to treat a certain type of cancer||
2527|033|U|(multiple myeloma). Talquetamab works by slowing or stopping the||
2527|034|U|growth of cancer cells.||
2527|035|B|||
2527|036|H|HOW TO USE:  Read the Medication Guide provided by your||
2527|037|H|pharmacist before you start using talquetamab and each time you||
2527|038|H|get a treatment. If you have any questions, ask your doctor or||
2527|039|H|pharmacist. Carry the Patient Wallet Card with you at all times.||
2527|040|H|Show the card to all of your health care providers to let them||
2527|041|H|know that you are being treated with talquetamab.||
2527|042|H|   This medication is given by injection under the skin as||
2527|043|H|directed by your doctor. The injection is given by a health care||
2527|044|H|professional, usually under the skin of the abdomen or thigh. To||
2527|045|H|reduce your risk of side effects, your doctor will start this||
2527|046|H|medication at a low dose and gradually increase your dose. These||
2527|047|H|starting doses are part of a "step-up dosing schedule." You must||
2527|048|H|stay in the hospital for 48 hours after each of the "step-up"||
2527|049|H|doses so your doctor can monitor you closely and help you manage||
2527|050|H|any side effects. The dosage and treatment schedule are based on||
2527|051|H|your medical condition, weight, and response to treatment.||
2527|052|H|   Before you receive this medication, your doctor will prescribe||
2527|053|H|other medications (such as acetaminophen, dexamethasone,||
2527|054|H|diphenhydramine) to help prevent side effects. Your doctor may||
2527|055|H|also prescribe other medications (such as antibiotics) to help||
2527|056|H|prevent infection. Carefully follow your doctor's directions for||
2527|057|H|all your medications.||
2527|058|B|||
2527|059|S|SIDE EFFECTS:  See also Warning section.||
2527|060|S|   Tiredness, nail problems, muscle/joint pain, loss of appetite,||
2527|061|S|weight loss, dry mouth/eyes/skin, or diarrhea may occur. Pain,||
2527|062|S|bruising, redness, itching, or swelling at the injection site may||
2527|063|S|also occur. If any of these effects last or get worse, tell your||
2527|064|S|doctor or pharmacist promptly.||
2527|065|S|   Pain or sores in the mouth and throat may occur. Brush your||
2527|066|S|teeth carefully/gently, avoid using mouthwash that contains||
2527|067|S|alcohol, and rinse your mouth often with cool water mixed with||
2527|068|S|baking soda or salt. It may also be best to eat soft, moist||
2527|069|S|foods.||
2527|070|S|   People using this medication may have serious side effects.||
2527|071|S|However, you have been prescribed this drug because your doctor||
2527|072|S|has judged that the benefit to you is greater than the risk of||
2527|073|S|side effects. Careful monitoring by your doctor may decrease your||
2527|074|S|risk.||
2527|075|S|   Tell your doctor right away if you have any serious side||
2527|076|S|effects, including: easy bruising/bleeding, signs of liver||
2527|077|S|disease (such as nausea/vomiting that doesn't stop,||
2527|078|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2527|079|S|of anemia (such as unusual tiredness, pale skin), oral problems||
2527|080|S|(changes in sense of taste, trouble swallowing).||
2527|081|S|   This medication may lower your ability to fight infections.||
2527|082|S|This may make you more likely to get a serious (rarely fatal)||
2527|083|S|infection or make any infection you have worse. Tell your doctor||
2527|084|S|right away if you have any signs of infection (such as sore||
2527|085|S|throat that doesn't go away, fever, chills).||
2527|086|S|   Talquetamab can cause skin problems (such as redness, rash,||
2527|087|S|small bumps) during treatment. However, you may not be able to||
2527|088|S|tell it apart from a rare rash that could be a sign of a severe||
2527|089|S|reaction. Tell your doctor right away if you develop any rash.||
2527|090|S|   A very serious allergic reaction to this drug is rare.||
2527|091|S|However, get medical help right away if you notice any symptoms||
2527|092|S|of a serious allergic reaction, including: rash, itching/swelling||
2527|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2527|094|S|breathing.||
2527|095|S|   This is not a complete list of possible side effects. If you||
2527|096|S|notice other effects not listed above, contact your doctor or||
2527|097|S|pharmacist.||
2527|098|S|   In the US -||
2527|099|S|   Call your doctor for medical advice about side effects. You||
2527|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2527|101|S|www.fda.gov/medwatch.||
2527|102|S|   In Canada - Call your doctor for medical advice about side||
2527|103|S|effects. You may report side effects to Health Canada at||
2527|104|S|1-866-234-2345.||
2527|105|B|||
2527|106|P|PRECAUTIONS:  Before using talquetamab, tell your doctor or||
2527|107|P|pharmacist if you are allergic to it; or if you have any other||
2527|108|P|allergies. This product may contain inactive ingredients, which||
2527|109|P|can cause allergic reactions or other problems. Talk to your||
2527|110|P|pharmacist for more details.||
2527|111|P|   Before using this medication, tell your doctor or pharmacist||
2527|112|P|your medical history, especially of: current/recent infections.||
2527|113|P|   This drug may make you dizzy or drowsy or affect your thinking||
2527|114|P|and coordination. Alcohol or marijuana (cannabis) can worsen||
2527|115|P|these effects. Do not drive, use machinery, or do anything that||
2527|116|P|needs alertness until you can do it safely. Limit alcoholic||
2527|117|P|beverages. Talk to your doctor if you are using marijuana||
2527|118|P|(cannabis).||
2527|119|P|   This medication can make you more likely to get infections or||
2527|120|P|may make current infections worse. Stay away from anyone who has||
2527|121|P|an infection that may easily spread (such as chickenpox,||
2527|122|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2527|123|P|exposed to an infection or for more details.||
2527|124|P|   Tell your health care professional that you are using||
2527|125|P|talquetamab before having any immunizations/vaccinations. Avoid||
2527|126|P|contact with people who have recently received live vaccines||
2527|127|P|(such as flu vaccine inhaled through the nose).||
2527|128|P|   To lower the chance of getting cut, bruised, or injured, use||
2527|129|P|caution with sharp objects like razors and nail cutters, and||
2527|130|P|avoid activities such as contact sports.||
2527|131|P|   Before having surgery, tell your doctor or dentist about all||
2527|132|P|the products you use (including prescription drugs,||
2527|133|P|nonprescription drugs, and herbal products).||
2527|134|P|   Tell your doctor if you are pregnant or plan to become||
2527|135|P|pregnant. You should not become pregnant while using talquetamab.||
2527|136|P|Talquetamab may harm an unborn baby. Your doctor should order a||
2527|137|P|pregnancy test before you start this medication. Ask about||
2527|138|P|reliable forms of birth control while using this medication and||
2527|139|P|for 3 months after the last dose. If you become pregnant, talk to||
2527|140|P|your doctor right away about the risks and benefits of this||
2527|141|P|medication.||
2527|142|P|   It is unknown if this drug passes into breast milk. Because of||
2527|143|P|the possible risk to the infant, breastfeeding is not recommended||
2527|144|P|while using this drug and for 3 months after the last dose.||
2527|145|P|Consult your doctor before breastfeeding.||
2527|146|B|||
2527|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2527|148|I|medications work or increase your risk for serious side effects.||
2527|149|I|This document does not contain all possible drug interactions.||
2527|150|I|Keep a list of all the products you use (including||
2527|151|I|prescription/nonprescription drugs and herbal products) and share||
2527|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
2527|153|I|the dosage of any medicines without your doctor's approval.||
2527|154|B|||
2527|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2527|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2527|157|O|poison control center right away. US residents can call||
2527|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2527|159|B|||
2527|160|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2527|161|N|liver function, weight) should be done before you start using||
2527|162|N|this medication and while you are using it. Keep all medical and||
2527|163|N|lab appointments. Consult your doctor for more details.||
2527|164|B|||
2527|165|D|MISSED DOSE:  It is important to get each dose of this medication||
2527|166|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2527|167|D|right away for a new dosing schedule.||
2527|168|B|||
2527|169|R|STORAGE:  Not applicable. This medication is given in a hospital||
2527|170|R|or clinic and will not be stored at home.||
2527|171|B|||
2527|172|M|MEDICAL ALERT:  Your condition can cause complications in a||
2527|173|M|medical emergency. For information about enrolling in MedicAlert,||
2527|174|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2527|175|B|||
2527|176|A|Information last revised October 2025.||
2527|177|A|Copyright(c) 2025 First Databank, Inc.||
2527|178|B|||
2528|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2528|002|Z|does NOT have all possible information about this product. This||
2528|003|Z|information does not assure that this product is safe, effective,||
2528|004|Z|or appropriate for you. This information is not individual||
2528|005|Z|medical advice and does not substitute for the advice of your||
2528|006|Z|health care professional. Always ask your health care||
2528|007|Z|professional for complete information about this product and your||
2528|008|Z|specific health needs.||
2528|009|B|||
2528|010|T|ELRANATAMAB - INJECTION||
2528|011|B|||
2528|012|C|COMMON BRAND NAME(S): Elrexfio||
2528|013|B|||
2528|014|W|WARNING:  Elranatamab may cause a certain serious (even fatal)||
2528|015|W|side effect known as cytokine release syndrome-CRS. Careful||
2528|016|W|monitoring and prompt treatment may decrease your risk. Tell your||
2528|017|W|doctor right away if you develop symptoms such as fever, chills,||
2528|018|W|headache, fast heartbeat, trouble breathing, or||
2528|019|W|dizziness/lightheadedness.||
2528|020|W|   This medication can also cause serious (even fatal) nervous||
2528|021|W|system problems. Tell your doctor right away if you have any||
2528|022|W|symptoms such as confusion, trouble staying awake, changes in||
2528|023|W|your handwriting, shaking, trouble speaking, or||
2528|024|W|burning/throbbing/stabbing pain.||
2528|025|W|   To receive elranatamab in the United States, you must||
2528|026|W|understand, agree to, and carefully follow the requirements of||
2528|027|W|the REMS Program for this medication. If you live in Canada or||
2528|028|W|any other country, consult your doctor and pharmacist for your||
2528|029|W|country's regulations.||
2528|030|B|||
2528|031|U|USES:  This medication is used to treat a certain type of cancer||
2528|032|U|(multiple myeloma). Elranatamab works by slowing or stopping the||
2528|033|U|growth of cancer cells.||
2528|034|B|||
2528|035|H|HOW TO USE:  Read the Medication Guide provided by your||
2528|036|H|pharmacist before you start using elranatamab and each time you||
2528|037|H|get a treatment. If you have any questions, ask your doctor or||
2528|038|H|pharmacist. Carry the Patient Wallet Card with you at all times.||
2528|039|H|Show the card to all of your health care providers to let them||
2528|040|H|know that you are being treated with elranatamab.||
2528|041|H|   This medication is given by injection under the skin as||
2528|042|H|directed by your doctor. The injection is given by a health care||
2528|043|H|professional, usually under the skin of the abdomen or thigh. To||
2528|044|H|reduce your risk of side effects, your doctor will start this||
2528|045|H|medication at a low dose and gradually increase your dose. These||
2528|046|H|starting doses are part of a "step-up dosing schedule." You must||
2528|047|H|stay in the hospital for 48 hours after your first "step-up" dose||
2528|048|H|and 24 hours after the second "step-up" dose so your doctor can||
2528|049|H|monitor you closely and help you manage any side effects. The||
2528|050|H|treatment schedule is based on your medical condition and||
2528|051|H|response to treatment.||
2528|052|H|   Before you receive this medication, your doctor will prescribe||
2528|053|H|other medications (such as acetaminophen, dexamethasone,||
2528|054|H|diphenhydramine) to help prevent side effects. Your doctor may||
2528|055|H|also prescribe other medications (such as antibiotics,||
2528|056|H|antivirals) to help prevent infection. Carefully follow your||
2528|057|H|doctor's directions for all your medications.||
2528|058|B|||
2528|059|S|SIDE EFFECTS:  See also Warning section.||
2528|060|S|   Tiredness, muscle/joint pain, nausea, decreased appetite, or||
2528|061|S|diarrhea may occur. Pain, bruising, redness, itching, or swelling||
2528|062|S|at the injection site may also occur. If any of these effects||
2528|063|S|last or get worse, tell your doctor or pharmacist promptly.||
2528|064|S|   People using this medication may have serious side effects.||
2528|065|S|However, you have been prescribed this drug because your doctor||
2528|066|S|has judged that the benefit to you is greater than the risk of||
2528|067|S|side effects. Careful monitoring by your doctor may decrease your||
2528|068|S|risk.||
2528|069|S|   Tell your doctor right away if you have any serious side||
2528|070|S|effects, including: easy bruising/bleeding, signs of liver||
2528|071|S|disease (such as nausea/vomiting that doesn't stop,||
2528|072|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2528|073|S|of anemia (such as unusual tiredness, pale skin).||
2528|074|S|   This medication may lower your ability to fight infections.||
2528|075|S|This may make you more likely to get a serious (rarely fatal)||
2528|076|S|infection or make any infection you have worse. Tell your doctor||
2528|077|S|right away if you have any signs of infection (such as sore||
2528|078|S|throat that doesn't go away, fever, chills).||
2528|079|S|   Elranatamab can cause a rash that is usually not serious.||
2528|080|S|However, you may not be able to tell it apart from a rare rash||
2528|081|S|that could be a sign of a severe reaction. Tell your doctor right||
2528|082|S|away if you develop any rash.||
2528|083|S|   A very serious allergic reaction to this drug is rare.||
2528|084|S|However, get medical help right away if you notice any symptoms||
2528|085|S|of a serious allergic reaction, including: rash, itching/swelling||
2528|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2528|087|S|breathing.||
2528|088|S|   This is not a complete list of possible side effects. If you||
2528|089|S|notice other effects not listed above, contact your doctor or||
2528|090|S|pharmacist.||
2528|091|S|   In the US -||
2528|092|S|   Call your doctor for medical advice about side effects. You||
2528|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2528|094|S|www.fda.gov/medwatch.||
2528|095|S|   In Canada - Call your doctor for medical advice about side||
2528|096|S|effects. You may report side effects to Health Canada at||
2528|097|S|1-866-234-2345.||
2528|098|B|||
2528|099|P|PRECAUTIONS:  Before using elranatamab, tell your doctor or||
2528|100|P|pharmacist if you are allergic to it; or if you have any other||
2528|101|P|allergies. This product may contain inactive ingredients, which||
2528|102|P|can cause allergic reactions or other problems. Talk to your||
2528|103|P|pharmacist for more details.||
2528|104|P|   Before using this medication, tell your doctor or pharmacist||
2528|105|P|your medical history, especially of: current/recent infections.||
2528|106|P|   This drug may make you dizzy or affect your thinking and||
2528|107|P|coordination. Alcohol or marijuana (cannabis) can worsen these||
2528|108|P|effects. Do not drive, use machinery, or do anything that needs||
2528|109|P|alertness for 48 hours after each of the two "step-up" doses and||
2528|110|P|after the first "treatment" dose. At all other times while using||
2528|111|P|this medication, do not drive, use machinery, or do anything that||
2528|112|P|needs alertness until you can do it safely. Limit alcoholic||
2528|113|P|beverages. Talk to your doctor if you are using marijuana||
2528|114|P|(cannabis).||
2528|115|P|   This medication can make you more likely to get infections or||
2528|116|P|may make current infections worse. Stay away from anyone who has||
2528|117|P|an infection that may easily spread (such as chickenpox,||
2528|118|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2528|119|P|exposed to an infection or for more details.||
2528|120|P|   Tell your health care professional that you are using||
2528|121|P|elranatamab before having any immunizations/vaccinations. Avoid||
2528|122|P|contact with people who have recently received live vaccines||
2528|123|P|(such as flu vaccine inhaled through the nose).||
2528|124|P|   To lower the chance of getting cut, bruised, or injured, use||
2528|125|P|caution with sharp objects like razors and nail cutters, and||
2528|126|P|avoid activities such as contact sports.||
2528|127|P|   Before having surgery, tell your doctor or dentist about all||
2528|128|P|the products you use (including prescription drugs,||
2528|129|P|nonprescription drugs, and herbal products).||
2528|130|P|   Tell your doctor if you are pregnant or plan to become||
2528|131|P|pregnant. You should not become pregnant while using elranatamab.||
2528|132|P|Elranatamab may harm an unborn baby. Your doctor should order a||
2528|133|P|pregnancy test before you start this medication. Ask about||
2528|134|P|reliable forms of birth control while using this medication and||
2528|135|P|for 4 months after the last dose. If you become pregnant, talk to||
2528|136|P|your doctor right away about the risks and benefits of this||
2528|137|P|medication.||
2528|138|P|   It is unknown if this drug passes into breast milk. Because of||
2528|139|P|the possible risk to the infant, breastfeeding is not recommended||
2528|140|P|while using this drug and for 4 months after the last dose.||
2528|141|P|Consult your doctor before breastfeeding.||
2528|142|B|||
2528|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2528|144|I|medications work or increase your risk for serious side effects.||
2528|145|I|This document does not contain all possible drug interactions.||
2528|146|I|Keep a list of all the products you use (including||
2528|147|I|prescription/nonprescription drugs and herbal products) and share||
2528|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
2528|149|I|the dosage of any medicines without your doctor's approval.||
2528|150|B|||
2528|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2528|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2528|153|O|poison control center right away. US residents can call||
2528|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2528|155|B|||
2528|156|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2528|157|N|liver function) should be done before you start using this||
2528|158|N|medication and while you are using it. Keep all medical and lab||
2528|159|N|appointments. Consult your doctor for more details.||
2528|160|B|||
2528|161|D|MISSED DOSE:  It is important to get each dose of this medication||
2528|162|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2528|163|D|right away for a new dosing schedule.||
2528|164|B|||
2528|165|R|STORAGE:  Not applicable. This medication is given in a hospital||
2528|166|R|or clinic and will not be stored at home.||
2528|167|B|||
2528|168|M|MEDICAL ALERT:  Your condition can cause complications in a||
2528|169|M|medical emergency. For information about enrolling in MedicAlert,||
2528|170|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2528|171|B|||
2528|172|A|Information last revised April 2025.||
2528|173|A|Copyright(c) 2025 First Databank, Inc.||
2528|174|B|||
2529|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2529|002|Z|does NOT have all possible information about this product. This||
2529|003|Z|information does not assure that this product is safe, effective,||
2529|004|Z|or appropriate for you. This information is not individual||
2529|005|Z|medical advice and does not substitute for the advice of your||
2529|006|Z|health care professional. Always ask your health care||
2529|007|Z|professional for complete information about this product and your||
2529|008|Z|specific health needs.||
2529|009|B|||
2529|010|T|AVACINCAPTAD PEGOL - INTRAOCULAR||
2529|011|B|||
2529|012|C|COMMON BRAND NAME(S): Izervay||
2529|013|B|||
2529|014|U|USES:  Avacincaptad pegol is used to treat a certain serious eye||
2529|015|U|condition (geographic atrophy). It may help delay vision loss.||
2529|016|U|Avacincaptad pegol works by helping to block your immune system||
2529|017|U|from destroying cells in your eye.||
2529|018|B|||
2529|019|H|HOW TO USE:  This medication is prepared and given by injection||
2529|020|H|into the affected eye(s) by a health care professional. The||
2529|021|H|affected eye is numbed before each injection. After the||
2529|022|H|injection, you will remain in the doctor's office for a while,||
2529|023|H|and your eye(s) and vision will be monitored.||
2529|024|H|   This medication is given as directed by your doctor, usually||
2529|025|H|once monthly for up to 12 months.||
2529|026|H|   Use this medication regularly to get the most benefit from it.||
2529|027|H|To help you remember, mark your calendar with a reminder.||
2529|028|H|   Tell your doctor if your condition gets worse.||
2529|029|B|||
2529|030|S|SIDE EFFECTS:  Eye irritation or swelling may occur. If either of||
2529|031|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2529|032|S|promptly.||
2529|033|S|   Remember that this medication has been prescribed because your||
2529|034|S|doctor has judged that the benefit to you is greater than the||
2529|035|S|risk of side effects. Many people using this medication do not||
2529|036|S|have serious side effects.||
2529|037|S|   Tell your doctor right away if you have any serious side||
2529|038|S|effects, including: floaters (blurry shapes that seem to float in||
2529|039|S|front of your eyes).||
2529|040|S|   This medication may rarely increase your risk for developing||
2529|041|S|certain serious eye conditions (endophthalmitis or retinal||
2529|042|S|detachment). Get medical help right away if you notice any of||
2529|043|S|these symptoms in the affected eye(s): pain, redness, sensitivity||
2529|044|S|to light, vision changes (such as blurred vision, loss of||
2529|045|S|vision).||
2529|046|S|   A very serious allergic reaction to this drug is rare.||
2529|047|S|However, get medical help right away if you notice any symptoms||
2529|048|S|of a serious allergic reaction, including: rash, itching/swelling||
2529|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2529|050|S|breathing.||
2529|051|S|   This is not a complete list of possible side effects. If you||
2529|052|S|notice other effects not listed above, contact your doctor or||
2529|053|S|pharmacist.||
2529|054|S|   In the US -||
2529|055|S|   Call your doctor for medical advice about side effects. You||
2529|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2529|057|S|www.fda.gov/medwatch.||
2529|058|S|   In Canada - Call your doctor for medical advice about side||
2529|059|S|effects. You may report side effects to Health Canada at||
2529|060|S|1-866-234-2345.||
2529|061|B|||
2529|062|P|PRECAUTIONS:  Before using avacincaptad pegol, tell your doctor||
2529|063|P|or pharmacist if you are allergic to it; or if you have any other||
2529|064|P|allergies. This product may contain inactive ingredients, which||
2529|065|P|can cause allergic reactions or other problems. Talk to your||
2529|066|P|pharmacist for more details.||
2529|067|P|   Before using this medication, tell your doctor or pharmacist||
2529|068|P|your medical history, especially of: current eye||
2529|069|P|infection/swelling.||
2529|070|P|   This drug may cause blurred vision. Do not drive, use||
2529|071|P|machinery, or do anything that needs clear vision until you can||
2529|072|P|do it safely.||
2529|073|P|   Before having surgery, tell your doctor or dentist about all||
2529|074|P|the products you use (including prescription drugs,||
2529|075|P|nonprescription drugs, and herbal products).||
2529|076|P|   During pregnancy, this medication should be used only when||
2529|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
2529|078|P|   It is unknown if this drug passes into breast milk. Consult||
2529|079|P|your doctor before breastfeeding.||
2529|080|B|||
2529|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2529|082|I|medications work or increase your risk for serious side effects.||
2529|083|I|This document does not contain all possible drug interactions.||
2529|084|I|Keep a list of all the products you use (including||
2529|085|I|prescription/nonprescription drugs and herbal products) and share||
2529|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
2529|087|I|the dosage of any medicines without your doctor's approval.||
2529|088|B|||
2529|089|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2529|090|O|has overdosed and has serious symptoms such as passing out or||
2529|091|O|trouble breathing, call 911. Otherwise, call a poison control||
2529|092|O|center right away. US residents can call 1-800-222-1222. Canada||
2529|093|O|residents can call 1-844-764-7669.||
2529|094|B|||
2529|095|N|NOTES:  Medical tests (such as eye exams) should be done while||
2529|096|N|you are using this medication. Keep all medical appointments.||
2529|097|N|Consult your doctor for more details.||
2529|098|B|||
2529|099|D|MISSED DOSE:  It is important to get each dose of this medication||
2529|100|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2529|101|D|right away for a new dosing schedule.||
2529|102|B|||
2529|103|R|STORAGE:  Not applicable. This medication is given in a hospital||
2529|104|R|or clinic or doctor's office and will not be stored at home.||
2529|105|B|||
2529|106|A|Information last revised October 2024.||
2529|107|A|Copyright(c) 2025 First Databank, Inc.||
2529|108|B|||
2530|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2530|002|Z|does NOT have all possible information about this product. This||
2530|003|Z|information does not assure that this product is safe, effective,||
2530|004|Z|or appropriate for you. This information is not individual||
2530|005|Z|medical advice and does not substitute for the advice of your||
2530|006|Z|health care professional. Always ask your health care||
2530|007|Z|professional for complete information about this product and your||
2530|008|Z|specific health needs.||
2530|009|B|||
2530|010|T|ALBUTEROL/ BUDESONIDE HFA INHALER - ORAL INHALATION||
2530|011|F|(al-BUE-ter-ol/bue-DES-oh-nide)||
2530|012|B|||
2530|013|C|COMMON BRAND NAME(S): Airsupra||
2530|014|B|||
2530|015|U|USES:  This product is used to prevent and treat wheezing and||
2530|016|U|shortness of breath caused by asthma. It is a quick-relief||
2530|017|U|product. It contains 2 medications: albuterol and budesonide.||
2530|018|U|Albuterol (also known as salbutamol in some countries) belongs to||
2530|019|U|a class of drugs known as bronchodilators. It works by relaxing||
2530|020|U|the muscles around the airways so that they open up and you can||
2530|021|U|breathe more easily. Budesonide belongs to a class of drugs known||
2530|022|U|as corticosteroids. It works by reducing swelling (inflammation)||
2530|023|U|of the airways in the lungs to make breathing easier. Controlling||
2530|024|U|symptoms of breathing problems can decrease time lost from work||
2530|025|U|or school.||
2530|026|B|||
2530|027|H|HOW TO USE:  Read the Patient Information Leaflet and||
2530|028|H|Instructions for Use provided by your pharmacist before you start||
2530|029|H|using this medication and each time you get a refill. Follow the||
2530|030|H|illustrated directions for the proper use of this medication. If||
2530|031|H|you have any questions, ask your doctor or pharmacist.||
2530|032|H|   Shake the canister well before using. Follow the instructions||
2530|033|H|for test sprays in the air if you are using a canister for the||
2530|034|H|first time, if you have not used it for more than a week, if you||
2530|035|H|have cleaned it, or if it was dropped. A fine mist is a sign that||
2530|036|H|the inhaler is working properly. Avoid spraying the medication in||
2530|037|H|your eyes. If you are using other inhalers at the same time, wait||
2530|038|H|at least one minute between the use of each medication.||
2530|039|H|   Inhale this medication by mouth as directed by your doctor,||
2530|040|H|usually as needed. Do not use more than 12 puffs in 24 hours. Do||
2530|041|H|not increase your dose or use this drug more often than||
2530|042|H|prescribed without your doctor's approval. Using too much of this||
2530|043|H|medication will increase your risk of serious (possibly fatal)||
2530|044|H|side effects.||
2530|045|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
2530|046|H|from developing, gargle and rinse your mouth with water after||
2530|047|H|each use. Do not swallow the rinse water.||
2530|048|H|   The dosage is based on your medical condition and response to||
2530|049|H|treatment.||
2530|050|H|   If you are regularly using a different corticosteroid taken by||
2530|051|H|mouth (such as prednisone), you should not stop using it unless||
2530|052|H|directed by your doctor. You may have withdrawal symptoms if the||
2530|053|H|drug is suddenly stopped. Some conditions (such as asthma,||
2530|054|H|allergies) may become worse when the drug is suddenly stopped. To||
2530|055|H|prevent withdrawal symptoms (such as weakness, weight loss,||
2530|056|H|nausea, muscle pain, headache, tiredness, dizziness), your doctor||
2530|057|H|may direct you to slowly lower the dose of your old medication||
2530|058|H|after you begin using this product. Consult your doctor or||
2530|059|H|pharmacist for more details, and report any withdrawal reactions||
2530|060|H|right away. See also Precautions section.||
2530|061|H|   Always have quick-relief inhalers with you. Keep track of the||
2530|062|H|number of inhalations you use and discard the inhaler after you||
2530|063|H|have used the labeled number of inhalations on the product||
2530|064|H|package. Also count the test sprays used to prime the inhaler.||
2530|065|H|   Learn which of your inhalers you should use every day||
2530|066|H|(controller drugs) and which you should use if your breathing||
2530|067|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
2530|068|H|time what you should do if you have new or worsening cough or||
2530|069|H|shortness of breath, wheezing, increased sputum, worsening peak||
2530|070|H|flow meter readings, waking up at night with trouble breathing,||
2530|071|H|if you use your quick-relief inhaler more often (more than 2 days||
2530|072|H|a week), or if your quick-relief inhaler does not seem to be||
2530|073|H|working well. Learn when you can treat sudden breathing problems||
2530|074|H|by yourself and when you must get medical help right away.||
2530|075|H|   Tell your doctor if you do not get better or if you get worse.||
2530|076|B|||
2530|077|S|SIDE EFFECTS:  See also Precautions section.||
2530|078|S|   Dry/irritated throat, headache, hoarseness, or coughing may||
2530|079|S|occur as your body adjusts to the medication. If any of these||
2530|080|S|effects last or get worse, tell your doctor or pharmacist||
2530|081|S|promptly.||
2530|082|S|   Remember that this medication has been prescribed because your||
2530|083|S|doctor has judged that the benefit to you is greater than the||
2530|084|S|risk of side effects. Many people using this medication do not||
2530|085|S|have serious side effects.||
2530|086|S|   This medication may raise your blood pressure. Check your||
2530|087|S|blood pressure regularly and tell your doctor if the results are||
2530|088|S|high.||
2530|089|S|   Tell your doctor right away if you have any serious side||
2530|090|S|effects, including: white patches in your mouth or on your||
2530|091|S|tongue, weakness, bone pain, nausea/vomiting, increased||
2530|092|S|thirst/urination, vision problems, signs of infections (such as||
2530|093|S|sore throat that doesn't go away, fever, chills).||
2530|094|S|   Rarely, this medication has caused severe (rarely fatal),||
2530|095|S|sudden worsening of breathing problems/asthma (paradoxical||
2530|096|S|bronchospasm) right after you use it. If you experience sudden||
2530|097|S|wheezing, get medical help right away.||
2530|098|S|   Get medical help right away if you have any very serious side||
2530|099|S|effects, including: chest pain, fast/irregular heartbeat.||
2530|100|S|   A very serious allergic reaction to this drug is rare.||
2530|101|S|However, get medical help right away if you notice any symptoms||
2530|102|S|of a serious allergic reaction, including: rash, itching/swelling||
2530|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2530|104|S|breathing.||
2530|105|S|   This is not a complete list of possible side effects. If you||
2530|106|S|notice other effects not listed above, contact your doctor or||
2530|107|S|pharmacist.||
2530|108|S|   In the US -||
2530|109|S|   Call your doctor for medical advice about side effects. You||
2530|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2530|111|S|www.fda.gov/medwatch.||
2530|112|S|   In Canada - Call your doctor for medical advice about side||
2530|113|S|effects. You may report side effects to Health Canada at||
2530|114|S|1-866-234-2345.||
2530|115|B|||
2530|116|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2530|117|P|pharmacist if you are allergic to albuterol or budesonide; or if||
2530|118|P|you have any other allergies. This product may contain inactive||
2530|119|P|ingredients, which can cause allergic reactions or other||
2530|120|P|problems. Talk to your pharmacist for more details.||
2530|121|P|   Before using this medication, tell your doctor or pharmacist||
2530|122|P|your medical history, especially of: current/past infections||
2530|123|P|(such as tuberculosis, herpes), bone loss (osteoporosis), eye||
2530|124|P|problems (such as cataracts, glaucoma), heart problems (such as||
2530|125|P|irregular heartbeat, angina, heart attack), high blood pressure,||
2530|126|P|seizure, thyroid problems, diabetes, liver problems.||
2530|127|P|   If you have switched from a corticosteroid taken by mouth||
2530|128|P|(such as prednisone tablets) to this inhaler within the past 12||
2530|129|P|months, or if you have been using this product in||
2530|130|P|higher-than-usual doses for a long time, it may be more difficult||
2530|131|P|for your body to respond to physical stress. Before having||
2530|132|P|surgery or emergency treatment, or if you get a serious||
2530|133|P|illness/injury, tell your doctor or dentist that you are using||
2530|134|P|this medication or have used a corticosteroid taken by mouth||
2530|135|P|within the past 12 months. Tell your doctor right away if you||
2530|136|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
2530|137|P|card or medical ID bracelet that says you use (or have used)||
2530|138|P|corticosteroid medications.||
2530|139|P|   This medication may mask signs of infection. It can make you||
2530|140|P|more likely to get infections or may worsen any current||
2530|141|P|infections. Avoid contact with people who have infections that||
2530|142|P|may spread to others (such as chickenpox, measles, flu). Consult||
2530|143|P|your doctor if you have been exposed to an infection or for more||
2530|144|P|details.||
2530|145|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
2530|146|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
2530|147|P|use machinery, or do anything that needs alertness or clear||
2530|148|P|vision until you can do it safely. Limit alcoholic beverages.||
2530|149|P|Talk to your doctor if you are using marijuana (cannabis).||
2530|150|P|   Before having surgery, tell your doctor or dentist about all||
2530|151|P|the products you use (including prescription drugs,||
2530|152|P|nonprescription drugs, and herbal products).||
2530|153|P|   During pregnancy, this medication should be used only when||
2530|154|P|clearly needed. Discuss the risks and benefits with your doctor.||
2530|155|P|   Budesonide passes into breast milk. It is unknown if albuterol||
2530|156|P|passes into breast milk. Consult your doctor before||
2530|157|P|breastfeeding.||
2530|158|B|||
2530|159|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2530|160|I|medications work or increase your risk for serious side effects.||
2530|161|I|This document does not contain all possible drug interactions.||
2530|162|I|Keep a list of all the products you use (including||
2530|163|I|prescription/nonprescription drugs and herbal products) and share||
2530|164|I|it with your doctor and pharmacist. Do not start, stop, or change||
2530|165|I|the dosage of any medicines without your doctor's approval.||
2530|166|I|   A product that may interact with this drug is: desmopressin.||
2530|167|I|   This product contains albuterol. It is very similar to||
2530|168|I|levalbuterol. Do not use other medications containing albuterol||
2530|169|I|or levalbuterol while using this product.||
2530|170|B|||
2530|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2530|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2530|173|O|poison control center right away. US residents can call||
2530|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2530|175|O|Symptoms of overdose may include: fast/pounding/irregular||
2530|176|O|heartbeat, severe shaking (tremors), seizures.||
2530|177|B|||
2530|178|N|NOTES:  Do not share this medication with others.||
2530|179|N|   Lab and/or medical tests (such as cortisol levels, lung||
2530|180|N|function, eye exams, bone density tests, blood pressure) should||
2530|181|N|be done while you are using this medication. Keep all medical and||
2530|182|N|lab appointments. Consult your doctor for more details.||
2530|183|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
2530|184|N|mold that can worsen breathing problems. Because the flu virus||
2530|185|N|can also worsen breathing problems, ask your doctor or pharmacist||
2530|186|N|if you should have a flu shot every year.||
2530|187|N|   This medication may cause bone loss (osteoporosis) in adults||
2530|188|N|when used for a long time. Lifestyle changes that may help reduce||
2530|189|N|the risk of bone problems include doing weight-bearing exercise,||
2530|190|N|stopping smoking, limiting alcohol, and getting enough calcium||
2530|191|N|and vitamin D. Talk to your doctor for more details.||
2530|192|B|||
2530|193|D|MISSED DOSE:  Not applicable.||
2530|194|B|||
2530|195|R|STORAGE:  Store at room temperature away from moisture, heat, and||
2530|196|R|sunlight. Do not store in the bathroom. Do not puncture the||
2530|197|R|canister or expose it to high heat or open flame. Do not open the||
2530|198|R|original foil package until you are ready to use the medication.||
2530|199|R|Once the foil package is opened, this medication expires after 6||
2530|200|R|to 12 months (depending on your product). Keep all medications||
2530|201|R|away from children and pets.||
2530|202|R|   Do not flush medications down the toilet or pour them into a||
2530|203|R|drain unless instructed to do so. Properly discard this product||
2530|204|R|when it is expired or no longer needed. Consult your pharmacist||
2530|205|R|or local waste disposal company.||
2530|206|B|||
2530|207|M|MEDICAL ALERT:  Your condition can cause complications in a||
2530|208|M|medical emergency. For information about enrolling in MedicAlert,||
2530|209|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2530|210|B|||
2530|211|A|Information last revised September 2025.||
2530|212|A|Copyright(c) 2025 First Databank, Inc.||
2530|213|B|||
2531|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2531|002|Z|does NOT have all possible information about this product. This||
2531|003|Z|information does not assure that this product is safe, effective,||
2531|004|Z|or appropriate for you. This information is not individual||
2531|005|Z|medical advice and does not substitute for the advice of your||
2531|006|Z|health care professional. Always ask your health care||
2531|007|Z|professional for complete information about this product and your||
2531|008|Z|specific health needs.||
2531|009|B|||
2531|010|T|NIRAPARIB/ABIRATERONE - ORAL||
2531|011|B|||
2531|012|C|COMMON BRAND NAME(S): Akeega||
2531|013|B|||
2531|014|U|USES:  This combination medication is used to treat prostate||
2531|015|U|cancer. It contains 2 medications: niraparib and abiraterone.||
2531|016|U|Niraparib works by slowing the growth of cancer cells.||
2531|017|U|Abiraterone works by decreasing the amount of testosterone the||
2531|018|U|body makes, which helps slow down the growth and spread of||
2531|019|U|prostate cancer.||
2531|020|B|||
2531|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2531|022|H|from your pharmacist before you start taking this product and||
2531|023|H|each time you get a refill. If you have any questions, ask your||
2531|024|H|doctor or pharmacist.||
2531|025|H|   Take this medication by mouth on an empty stomach as directed||
2531|026|H|by your doctor, usually once daily. Swallow the tablets whole||
2531|027|H|with water. Do not break, crush, or chew the tablets. Do not eat||
2531|028|H|food for 2 hours before and 1 hour after taking this medication.||
2531|029|H|Taking this medication with food increases the amount of this||
2531|030|H|drug in your body and increases the risk of side effects.||
2531|031|H|   The dosage is based on your medical condition, response to||
2531|032|H|treatment, and other medications you may be taking. Be sure to||
2531|033|H|tell your doctor and pharmacist about all the products you use||
2531|034|H|(including prescription drugs, nonprescription drugs, and herbal||
2531|035|H|products).||
2531|036|H|   Take this medication regularly to get the most benefit from||
2531|037|H|it. To help you remember, take it at the same time each day.||
2531|038|H|   Do not increase your dose or use this drug more often or for||
2531|039|H|longer than prescribed. Your condition will not improve any||
2531|040|H|faster, and your risk of serious side effects will increase.||
2531|041|H|   Since this drug can be absorbed through the skin and lungs and||
2531|042|H|may harm an unborn baby, women who are pregnant or who may become||
2531|043|H|pregnant should not handle this medication or breathe the dust||
2531|044|H|from the tablets.||
2531|045|B|||
2531|046|S|SIDE EFFECTS:  Constipation, trouble sleeping, dizziness, nausea,||
2531|047|S|or vomiting may occur. Rarely, nausea and vomiting can be severe.||
2531|048|S|Taking this medication at bedtime may help reduce nausea. In some||
2531|049|S|cases, your doctor may prescribe medication to prevent or relieve||
2531|050|S|nausea and vomiting. Limiting activity may help lessen some of||
2531|051|S|these effects. If any of these effects last or get worse, tell||
2531|052|S|your doctor or pharmacist promptly.||
2531|053|S|   People using this medication may have serious side effects.||
2531|054|S|However, you have been prescribed this drug because your doctor||
2531|055|S|has judged that the benefit to you is greater than the risk of||
2531|056|S|side effects. Careful monitoring by your doctor may decrease your||
2531|057|S|risk.||
2531|058|S|   This medication may raise your blood pressure and heart rate.||
2531|059|S|Check your blood pressure and heart rate regularly and tell your||
2531|060|S|doctor if the results are high. Your doctor may control your||
2531|061|S|blood pressure and heart rate with medication.||
2531|062|S|   Tell your doctor right away if you have any serious side||
2531|063|S|effects, including: swelling of the hands/ankles/feet, muscle||
2531|064|S|cramps/weakness, leg pain.||
2531|065|S|   This medication decreases bone marrow function, an effect that||
2531|066|S|may lead to a low number of blood cells such as red cells, white||
2531|067|S|cells, and platelets. This effect can cause anemia, decrease your||
2531|068|S|body's ability to fight an infection, or cause easy||
2531|069|S|bruising/bleeding. Rarely, this medication may also cause certain||
2531|070|S|cancers of the bone marrow or blood cells. Tell your doctor right||
2531|071|S|away if you develop any of the following symptoms: unusual||
2531|072|S|tiredness/weakness, pale skin, signs of infection (such as sore||
2531|073|S|throat that doesn't go away, fever, chills, painful urination,||
2531|074|S|pink/bloody urine), easy bruising/bleeding, weight loss.||
2531|075|S|   Rarely, this medication may cause a condition called PRES||
2531|076|S|(posterior reversible encephalopathy syndrome). Get medical help||
2531|077|S|right away if you develop a headache that doesn't go away,||
2531|078|S|seizures, sudden vision changes, or mental/mood changes (such as||
2531|079|S|confusion).||
2531|080|S|   Get medical help right away if you have any very serious side||
2531|081|S|effects, including: chest pain, fast/irregular heartbeat, severe||
2531|082|S|dizziness, fainting, symptoms of liver disease (such as||
2531|083|S|nausea/vomiting that doesn't stop, loss of appetite,||
2531|084|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2531|085|S|   A very serious allergic reaction to this drug is rare.||
2531|086|S|However, get medical help right away if you notice any symptoms||
2531|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2531|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2531|089|S|breathing.||
2531|090|S|   This is not a complete list of possible side effects. If you||
2531|091|S|notice other effects not listed above, contact your doctor or||
2531|092|S|pharmacist.||
2531|093|S|   In the US -||
2531|094|S|   Call your doctor for medical advice about side effects. You||
2531|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2531|096|S|www.fda.gov/medwatch.||
2531|097|S|   In Canada - Call your doctor for medical advice about side||
2531|098|S|effects. You may report side effects to Health Canada at||
2531|099|S|1-866-234-2345.||
2531|100|B|||
2531|101|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2531|102|P|pharmacist if you are allergic to niraparib or abiraterone; or if||
2531|103|P|you have any other allergies. This product may contain inactive||
2531|104|P|ingredients, which can cause allergic reactions or other||
2531|105|P|problems. Talk to your pharmacist for more details.||
2531|106|P|   Before using this medication, tell your doctor or pharmacist||
2531|107|P|your medical history, especially of: previous heart attack, high||
2531|108|P|blood pressure, liver disease, diabetes.||
2531|109|P|   This product can make you more likely to get infections or may||
2531|110|P|worsen any current infections. Avoid contact with people who have||
2531|111|P|infections that may spread to others (such as chickenpox,||
2531|112|P|measles, flu). Consult your doctor if you have been exposed to an||
2531|113|P|infection or for more details.||
2531|114|P|   Do not have immunizations/vaccinations without the consent of||
2531|115|P|your doctor. Avoid contact with people who have recently received||
2531|116|P|live vaccines (such as flu vaccine inhaled through the nose).||
2531|117|P|   To lower the chance of getting cut, bruised, or injured, use||
2531|118|P|caution with sharp objects like razors and nail cutters, and||
2531|119|P|avoid activities such as contact sports.||
2531|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2531|121|P|can make you more dizzy. Do not drive, use machinery, or do||
2531|122|P|anything that needs alertness until you can do it safely. Limit||
2531|123|P|alcoholic beverages. Talk to your doctor if you are using||
2531|124|P|marijuana (cannabis).||
2531|125|P|   This product may cause a condition that affects the heart||
2531|126|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2531|127|P|serious (rarely fatal) fast/irregular heartbeat and other||
2531|128|P|symptoms (such as severe dizziness, fainting) that need medical||
2531|129|P|attention right away.||
2531|130|P|   The risk of QT prolongation may be increased if you have||
2531|131|P|certain medical conditions or are taking other drugs that may||
2531|132|P|cause QT prolongation. Before using this product, tell your||
2531|133|P|doctor or pharmacist of all the drugs you take and if you have||
2531|134|P|any of the following conditions: certain heart problems (heart||
2531|135|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2531|136|P|history of certain heart problems (QT prolongation in the EKG,||
2531|137|P|sudden cardiac death).||
2531|138|P|   Low levels of potassium or magnesium in the blood may also||
2531|139|P|increase your risk of QT prolongation. This risk may increase if||
2531|140|P|you use certain drugs (such as diuretics/"water pills") or if you||
2531|141|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2531|142|P|Talk to your doctor about using this product safely.||
2531|143|P|   Using corticosteroid medications for a long time along with||
2531|144|P|this product can make it more difficult for your body to respond||
2531|145|P|to physical stress. Before having surgery or emergency treatment,||
2531|146|P|or if you get a serious illness/injury, tell your doctor or||
2531|147|P|dentist that you are using this medication or have used this||
2531|148|P|medication within the past 12 months. Tell your doctor right away||
2531|149|P|if you develop unusual/extreme tiredness or weight loss. If you||
2531|150|P|will be using this medication for a long time, carry a warning||
2531|151|P|card or medical ID bracelet that identifies your use of this||
2531|152|P|medication.||
2531|153|P|   Before having surgery, tell your doctor or dentist about all||
2531|154|P|the products you use (including prescription drugs,||
2531|155|P|nonprescription drugs, and herbal products).||
2531|156|P|   This medication should not be used by women, especially during||
2531|157|P|pregnancy or breastfeeding. It may harm an unborn or||
2531|158|P|breastfeeding baby. Men using this medication should ask about||
2531|159|P|reliable forms of birth control during treatment and for 4 months||
2531|160|P|after the last dose. Consult your doctor for more details.||
2531|161|B|||
2531|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2531|163|I|medications work or increase your risk for serious side effects.||
2531|164|I|This document does not contain all possible drug interactions.||
2531|165|I|Keep a list of all the products you use (including||
2531|166|I|prescription/nonprescription drugs and herbal products) and share||
2531|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
2531|168|I|the dosage of any medicines without your doctor's approval.||
2531|169|I|   A product that may interact with this drug is: radium Ra 223.||
2531|170|I|   Other medications can affect the removal of this product from||
2531|171|I|your body, which may affect how it works. Examples include drugs||
2531|172|I|used to treat seizures (such as carbamazepine, phenytoin,||
2531|173|I|phenobarbital, primidone), rifamycins (such as rifampin), St.||
2531|174|I|John's wort, among others.||
2531|175|B|||
2531|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2531|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2531|178|O|poison control center right away. US residents can call||
2531|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2531|180|B|||
2531|181|N|NOTES:  Do not share this medication with others.||
2531|182|N|   Lab and/or medical tests (such as complete blood count, blood||
2531|183|N|pressure, heart rate, potassium levels, liver function, PSA blood||
2531|184|N|test) should be done before you start taking this product and||
2531|185|N|while you are taking it. Keep all medical and lab appointments.||
2531|186|N|Consult your doctor for more details.||
2531|187|B|||
2531|188|D|MISSED DOSE:  It is important to take each dose of this||
2531|189|D|medication as scheduled. If you miss a dose, ask your doctor or||
2531|190|D|pharmacist right away for a new dosing schedule. Do not double||
2531|191|D|the dose to catch up.||
2531|192|B|||
2531|193|R|STORAGE:  Store at room temperature away from light and moisture.||
2531|194|R|Do not store in the bathroom. Keep all medications away from||
2531|195|R|children and pets.||
2531|196|R|   Do not flush medications down the toilet or pour them into a||
2531|197|R|drain unless instructed to do so. Properly discard this product||
2531|198|R|when it is expired or no longer needed. Consult your pharmacist||
2531|199|R|or local waste disposal company.||
2531|200|B|||
2531|201|M|MEDICAL ALERT:  Your condition can cause complications in a||
2531|202|M|medical emergency. For information about enrolling in MedicAlert,||
2531|203|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2531|204|B|||
2531|205|A|Information last revised July 2024.||
2531|206|A|Copyright(c) 2025 First Databank, Inc.||
2531|207|B|||
2532|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2532|002|Z|does NOT have all possible information about this product. This||
2532|003|Z|information does not assure that this product is safe, effective,||
2532|004|Z|or appropriate for you. This information is not individual||
2532|005|Z|medical advice and does not substitute for the advice of your||
2532|006|Z|health care professional. Always ask your health care||
2532|007|Z|professional for complete information about this product and your||
2532|008|Z|specific health needs.||
2532|009|B|||
2532|010|T|GADOLINIUM-BASED CONTRAST AGENT - INJECTION||
2532|011|B|||
2532|012|C|COMMON BRAND NAME(S): Clariscan, Dotarem, Elucirem, Eovist,||
2532|013|C|Gadavist, Multihance, Prohance, Vueway||
2532|014|B|||
2532|015|W|WARNING:  This medication may rarely cause kidney damage. The||
2532|016|W|risk of kidney damage is greater if you already have kidney||
2532|017|W|problems, if you are an older adult, or if you have high blood||
2532|018|W|pressure or diabetes. Your doctor should check how well your||
2532|019|W|kidneys are working before you receive this medication.||
2532|020|W|   See also Side Effects section.||
2532|021|B|||
2532|022|U|USES:  This medication is used before a magnetic resonance||
2532|023|U|imaging (MRI) scan. It belongs to a class of drugs known as||
2532|024|U|gadolinium-based contrast agents (GBCAs). This medication helps||
2532|025|U|the MRI scan make clearer images, so your doctor can more easily||
2532|026|U|diagnose your condition.||
2532|027|B|||
2532|028|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2532|029|H|Patient Information Leaflet provided by your pharmacist before||
2532|030|H|you start this medication. If you have any questions, ask your||
2532|031|H|health care professional.||
2532|032|H|   This medication is given by injection into a vein by a health||
2532|033|H|care provider. The injection is given as directed by your doctor.||
2532|034|H|The dosage is based on your medical condition and weight.||
2532|035|B|||
2532|036|S|SIDE EFFECTS:  Nausea, unpleasant taste, or headache may occur.||
2532|037|S|If any of these effects last or get worse, tell your health care||
2532|038|S|professional.||
2532|039|S|   Remember that this medication has been prescribed because your||
2532|040|S|doctor has judged that the benefit to you is greater than the||
2532|041|S|risk of side effects. Many people using this medication do not||
2532|042|S|have serious side effects.||
2532|043|S|   Tell your doctor right away if you have any serious side||
2532|044|S|effects, including: kidney problems (such as change in the amount||
2532|045|S|of urine), pain/swelling/redness at the injection site, swelling||
2532|046|S|ankles/feet.||
2532|047|S|   Get medical help right away if you have any very serious side||
2532|048|S|effects, including: dark patches on the skin,||
2532|049|S|hardening/tightening of the skin, joint stiffness, hip/rib pain,||
2532|050|S|muscle weakness, trouble moving, shortness of breath,||
2532|051|S|rapid/shallow breathing.||
2532|052|S|   A very serious allergic reaction to this drug is rare.||
2532|053|S|However, get medical help right away if you notice any symptoms||
2532|054|S|of a serious allergic reaction, including: rash, itching/swelling||
2532|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2532|056|S|breathing.||
2532|057|S|   This is not a complete list of possible side effects. If you||
2532|058|S|notice other effects not listed above, contact your doctor or||
2532|059|S|pharmacist.||
2532|060|S|   In the US -||
2532|061|S|   Call your doctor for medical advice about side effects. You||
2532|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2532|063|S|www.fda.gov/medwatch.||
2532|064|S|   In Canada - Call your doctor for medical advice about side||
2532|065|S|effects. You may report side effects to Health Canada at||
2532|066|S|1-866-234-2345.||
2532|067|B|||
2532|068|P|PRECAUTIONS:  Before using this medication, tell your health care||
2532|069|P|professional if you are allergic to it; or to other||
2532|070|P|gadolinium-based contrast agents (such as gadoterate meglumine,||
2532|071|P|gadoteridol, gadoxetate disodium, gadobenate dimeglumine,||
2532|072|P|gadobutrol, or gadopiclenol); or if you have any other allergies.||
2532|073|P|This product may contain inactive ingredients, which can cause||
2532|074|P|allergic reactions or other problems. Talk to your pharmacist for||
2532|075|P|more details.||
2532|076|P|   Before using this medication, tell your doctor or pharmacist||
2532|077|P|your medical history, especially of: kidney disease (including||
2532|078|P|being on dialysis), diabetes, high blood pressure.||
2532|079|P|   Gadolinium can stay in your body for months or years after||
2532|080|P|getting this medication. Studies have not found harmful effects||
2532|081|P|from gadolinium if your kidneys work normally. For more details||
2532|082|P|talk to your doctor.||
2532|083|P|   Before having surgery, tell your doctor or dentist about all||
2532|084|P|the products you use (including prescription drugs,||
2532|085|P|nonprescription drugs, and herbal products).||
2532|086|P|   During pregnancy, this medication should be used only when||
2532|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
2532|088|P|   This medication may pass into breast milk, but is unlikely to||
2532|089|P|harm a nursing infant. Consult your doctor before breastfeeding.||
2532|090|B|||
2532|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2532|092|I|medications work or increase your risk for serious side effects.||
2532|093|I|This document does not contain all possible drug interactions.||
2532|094|I|Keep a list of all the products you use (including||
2532|095|I|prescription/nonprescription drugs and herbal products) and share||
2532|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
2532|097|I|the dosage of any medicines without your doctor's approval.||
2532|098|B|||
2532|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2532|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2532|101|O|poison control center right away. US residents can call||
2532|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2532|103|B|||
2532|104|N|NOTES:  Do not share this medication with others.||
2532|105|N|   Lab and/or medical tests (such as kidney function) may be done||
2532|106|N|before you use this medication. Keep all medical and lab||
2532|107|N|appointments. Consult your doctor for more details.||
2532|108|B|||
2532|109|D|MISSED DOSE:  Not applicable. This medication is given once||
2532|110|D|before your imaging test.||
2532|111|B|||
2532|112|R|STORAGE:  Not applicable. This medication is given in a hospital||
2532|113|R|or clinic and will not be stored at home.||
2532|114|B|||
2532|115|A|Information last revised March 2025.||
2532|116|A|Copyright(c) 2025 First Databank, Inc.||
2532|117|B|||
2533|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2533|002|Z|does NOT have all possible information about this product. This||
2533|003|Z|information does not assure that this product is safe, effective,||
2533|004|Z|or appropriate for you. This information is not individual||
2533|005|Z|medical advice and does not substitute for the advice of your||
2533|006|Z|health care professional. Always ask your health care||
2533|007|Z|professional for complete information about this product and your||
2533|008|Z|specific health needs.||
2533|009|B|||
2533|010|T|DAPRODUSTAT - ORAL||
2533|011|F|(DAP-roe-DOO-stat)||
2533|012|B|||
2533|013|C|COMMON BRAND NAME(S): Jesduvroq||
2533|014|B|||
2533|015|W|WARNING:  Daprodustat may cause serious (sometimes fatal)||
2533|016|W|problems from blood clots (such as heart attack, stroke, blood||
2533|017|W|clots in the lungs or legs). You may be at increased risk if you||
2533|018|W|have a history of blood clots or heart/blood vessel disease. The||
2533|019|W|lowest effective dose of this medication should be used. It is||
2533|020|W|very important to keep all lab appointments since your doctor||
2533|021|W|will need to carefully monitor your red blood cell count and||
2533|022|W|hemoglobin level. Get medical help right away if any of these||
2533|023|W|side effects occur: shortness of breath/rapid breathing,||
2533|024|W|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
2533|025|W|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
2533|026|W|sudden/severe headaches, trouble speaking, weakness on one side||
2533|027|W|of the body, or sudden vision changes.||
2533|028|B|||
2533|029|U|USES:  This medication is used to treat anemia (low red blood||
2533|030|U|cell count) in people with long-term serious kidney disease||
2533|031|U|(chronic kidney disease) on kidney dialysis. Daprodustat works by||
2533|032|U|increasing a natural substance in your body (erythropoietin) that||
2533|033|U|signals the bone marrow to make more red blood cells.||
2533|034|B|||
2533|035|H|HOW TO USE:  Read the Medication Guide provided by your||
2533|036|H|pharmacist before you start taking daprodustat and each time you||
2533|037|H|get a refill. If you have any questions, ask your doctor or||
2533|038|H|pharmacist.||
2533|039|H|   Take this medication by mouth with or without food as directed||
2533|040|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2533|041|H|not cut, crush, or chew the tablets.||
2533|042|H|   The dosage is based on your medical condition, response to||
2533|043|H|treatment, lab tests, and other medications you may be taking. Be||
2533|044|H|sure to tell your doctor and pharmacist about all the products||
2533|045|H|you use (including prescription drugs, nonprescription drugs, and||
2533|046|H|herbal products).||
2533|047|H|   Use this medication regularly to get the most benefit from it.||
2533|048|H|To help you remember, take it at the same time each day.||
2533|049|H|   Do not increase your dose or use this drug more often or for||
2533|050|H|longer than prescribed. Your condition will not improve any||
2533|051|H|faster, and your risk of side effects will increase.||
2533|052|H|   Tell your doctor if your symptoms do not get better or if they||
2533|053|H|get worse.||
2533|054|B|||
2533|055|S|SIDE EFFECTS:  See also Warning section.||
2533|056|S|   Abdominal pain may occur. If this effect lasts or gets worse,||
2533|057|S|tell your doctor or pharmacist promptly.||
2533|058|S|   Remember that this medication has been prescribed because your||
2533|059|S|doctor has judged that the benefit to you is greater than the||
2533|060|S|risk of side effects. Many people using this medication do not||
2533|061|S|have serious side effects.||
2533|062|S|   This medication may raise your blood pressure. Check your||
2533|063|S|blood pressure regularly and tell your doctor if the results are||
2533|064|S|high. Your doctor may control your blood pressure with||
2533|065|S|medication.||
2533|066|S|   Tell your doctor right away if you have any serious side||
2533|067|S|effects, including: symptoms of heart failure (such as shortness||
2533|068|S|of breath, swelling ankles/feet, unusual tiredness,||
2533|069|S|unusual/sudden weight gain).||
2533|070|S|   Get medical help right away if you have any very serious side||
2533|071|S|effects, including: seizures, symptoms of stomach/intestinal||
2533|072|S|bleeding (such as black/bloody stools, vomit that contains blood||
2533|073|S|or looks like coffee grounds, dizziness).||
2533|074|S|   A very serious allergic reaction to this drug is rare.||
2533|075|S|However, get medical help right away if you notice any symptoms||
2533|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2533|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2533|078|S|breathing.||
2533|079|S|   This is not a complete list of possible side effects. If you||
2533|080|S|notice other effects not listed above, contact your doctor or||
2533|081|S|pharmacist.||
2533|082|S|   In the US -||
2533|083|S|   Call your doctor for medical advice about side effects. You||
2533|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2533|085|S|www.fda.gov/medwatch.||
2533|086|S|   In Canada - Call your doctor for medical advice about side||
2533|087|S|effects. You may report side effects to Health Canada at||
2533|088|S|1-866-234-2345.||
2533|089|B|||
2533|090|P|PRECAUTIONS:  See also Warning section.||
2533|091|P|   Before taking daprodustat, tell your doctor or pharmacist if||
2533|092|P|you are allergic to it; or if you have any other allergies. This||
2533|093|P|product may contain inactive ingredients, which can cause||
2533|094|P|allergic reactions or other problems. Talk to your pharmacist for||
2533|095|P|more details.||
2533|096|P|   Before using this medication, tell your doctor or pharmacist||
2533|097|P|your medical history, especially of: alcohol use, cancer, heart||
2533|098|P|failure, high blood pressure, liver disease, smoking,||
2533|099|P|stomach/intestinal problems (such as bleeding, ulcers).||
2533|100|P|   Before having surgery, tell your doctor or dentist about all||
2533|101|P|the products you use (including prescription drugs,||
2533|102|P|nonprescription drugs, and herbal products).||
2533|103|P|   During pregnancy, this medication should be used only when||
2533|104|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2533|105|P|benefits with your doctor.||
2533|106|P|   It is unknown if this medication passes into breast milk.||
2533|107|P|Because of the possible risk to the infant, breastfeeding is not||
2533|108|P|recommended while using this medication and for 1 week after the||
2533|109|P|last dose. Consult your doctor before breastfeeding.||
2533|110|B|||
2533|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2533|112|I|medications work or increase your risk for serious side effects.||
2533|113|I|This document does not contain all possible drug interactions.||
2533|114|I|Keep a list of all the products you use (including||
2533|115|I|prescription/nonprescription drugs and herbal products) and share||
2533|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
2533|117|I|the dosage of any medicines without your doctor's approval.||
2533|118|I|   Other medications can affect the removal of daprodustat from||
2533|119|I|your body, which may affect how daprodustat works. An example is||
2533|120|I|gemfibrozil, among others.||
2533|121|B|||
2533|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2533|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2533|124|O|poison control center right away. US residents can call||
2533|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2533|126|B|||
2533|127|N|NOTES:  Do not share this medication with others.||
2533|128|N|   Lab and/or medical tests (such as complete blood count, liver||
2533|129|N|function, blood pressure) should be done before you start taking||
2533|130|N|this medication and while you are taking it. Keep all medical and||
2533|131|N|lab appointments. Consult your doctor for more details.||
2533|132|N|   Blood tests for your iron levels will also be done and you may||
2533|133|N|be prescribed iron supplements. Your doctor may recommend that||
2533|134|N|you eat a well-balanced diet rich in iron sources (such as||
2533|135|N|raisins, figs, meat, eggs, vegetables, iron-fortified cereals).||
2533|136|N|Follow your doctor's instructions and dietary recommendations.||
2533|137|B|||
2533|138|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2533|139|D|remember. If you don't remember until the next day, skip the||
2533|140|D|missed dose. Take your next dose at the regular time. Do not||
2533|141|D|double the dose to catch up.||
2533|142|B|||
2533|143|R|STORAGE:  Store at room temperature away from light and moisture.||
2533|144|R|Do not store in the bathroom. Keep all medications away from||
2533|145|R|children and pets.||
2533|146|R|   Do not flush medications down the toilet or pour them into a||
2533|147|R|drain unless instructed to do so. Properly discard this product||
2533|148|R|when it is expired or no longer needed. Consult your pharmacist||
2533|149|R|or local waste disposal company.||
2533|150|B|||
2533|151|A|Information last revised July 2024.||
2533|152|A|Copyright(c) 2025 First Databank, Inc.||
2533|153|B|||
2534|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2534|002|Z|does NOT have all possible information about this product. This||
2534|003|Z|information does not assure that this product is safe, effective,||
2534|004|Z|or appropriate for you. This information is not individual||
2534|005|Z|medical advice and does not substitute for the advice of your||
2534|006|Z|health care professional. Always ask your health care||
2534|007|Z|professional for complete information about this product and your||
2534|008|Z|specific health needs.||
2534|009|B|||
2534|010|T|CAPSAICIN 8% - TOPICAL||
2534|011|F|(kap-SAY-i-sin)||
2534|012|B|||
2534|013|C|COMMON BRAND NAME(S): Qutenza||
2534|014|B|||
2534|015|U|USES:  This medication is used to relieve pain caused by nerve||
2534|016|U|damage due to diabetes or shingles (herpes zoster) infection.||
2534|017|U|Capsaicin works by decreasing a certain natural substance in your||
2534|018|U|body (substance P) that helps pass pain signals to the brain.||
2534|019|B|||
2534|020|H|HOW TO USE:  This medication is for use on the skin only. It is||
2534|021|H|applied to the affected area by a health care professional as||
2534|022|H|directed by your doctor, usually every 3 months as needed. It||
2534|023|H|should not be applied around your eyes, inside your nose or||
2534|024|H|mouth, or on the face or scalp. If the medication does get in||
2534|025|H|those areas, rinse with plenty of water. Tell your doctor right||
2534|026|H|away if you cough, sneeze, or have watery eyes, throat||
2534|027|H|irritation, or shortness of breath during the treatment.||
2534|028|H|   The dosage and length of treatment are based on your medical||
2534|029|H|condition and response to treatment.||
2534|030|H|   You may have burning or increased pain at the application site||
2534|031|H|during treatment. This may also raise your blood pressure. Tell||
2534|032|H|your doctor right away if these symptoms occur. You may be||
2534|033|H|directed to take another pain reliever (such as acetaminophen,||
2534|034|H|ibuprofen). Your doctor may also check your blood pressure.||
2534|035|H|   Tell your doctor if your condition lasts or gets worse.||
2534|036|B|||
2534|037|S|SIDE EFFECTS:  See also How to Use section.||
2534|038|S|   Warmth, itching, stinging, or burning on the application site||
2534|039|S|may occur. Trouble feeling or sensing touch, pain, or temperature||
2534|040|S|at the application site may also occur. If any of these effects||
2534|041|S|last or get worse, tell your doctor or pharmacist promptly.||
2534|042|S|   Remember that this medication has been prescribed because your||
2534|043|S|doctor has judged that the benefit to you is greater than the||
2534|044|S|risk of side effects. Many people using this medication do not||
2534|045|S|have serious side effects.||
2534|046|S|   Tell your doctor right away if you have any serious side||
2534|047|S|effects, including: blistering/swelling at the application site,||
2534|048|S|increased/unusual pain at the application site.||
2534|049|S|   A very serious allergic reaction to this drug is rare.||
2534|050|S|However, get medical help right away if you notice any symptoms||
2534|051|S|of a serious allergic reaction, including: rash, itching/swelling||
2534|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2534|053|S|breathing.||
2534|054|S|   This is not a complete list of possible side effects. If you||
2534|055|S|notice other effects not listed above, contact your doctor or||
2534|056|S|pharmacist.||
2534|057|S|   In the US -||
2534|058|S|   Call your doctor for medical advice about side effects. You||
2534|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2534|060|S|www.fda.gov/medwatch.||
2534|061|S|   In Canada - Call your doctor for medical advice about side||
2534|062|S|effects. You may report side effects to Health Canada at||
2534|063|S|1-866-234-2345.||
2534|064|B|||
2534|065|P|PRECAUTIONS:  Before using capsaicin, tell your doctor or||
2534|066|P|pharmacist if you are allergic to it; or to zucapsaicin; or to||
2534|067|P|hot peppers (from the Capsicum family); or if you have any other||
2534|068|P|allergies. This product may contain inactive ingredients, which||
2534|069|P|can cause allergic reactions or other problems. Talk to your||
2534|070|P|pharmacist for more details.||
2534|071|P|   Before using this medication, tell your doctor or pharmacist||
2534|072|P|your medical history, especially of: high blood pressure.||
2534|073|P|   The application site may be more sensitive to heat for a few||
2534|074|P|days after treatment. Limit activities that might expose the||
2534|075|P|application site to increased heat (such as taking hot||
2534|076|P|showers/baths, sun bathing, doing strenuous work/exercise). Wear||
2534|077|P|protective clothing to cover the application site when outdoors.||
2534|078|P|   Before having surgery, tell your doctor or dentist about all||
2534|079|P|the products you use (including prescription drugs,||
2534|080|P|nonprescription drugs, and herbal products).||
2534|081|P|   During pregnancy, this medication should be used only when||
2534|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
2534|083|P|   It is unknown if this medication passes into breast milk.||
2534|084|P|Consult your doctor before breastfeeding.||
2534|085|B|||
2534|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2534|087|I|medications work or increase your risk for serious side effects.||
2534|088|I|This document does not contain all possible drug interactions.||
2534|089|I|Keep a list of all the products you use (including||
2534|090|I|prescription/nonprescription drugs and herbal products) and share||
2534|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2534|092|I|the dosage of any medicines without your doctor's approval.||
2534|093|I|   Capsaicin is very similar to zucapsaicin. Do not use||
2534|094|I|medications containing zucapsaicin while using capsaicin.||
2534|095|B|||
2534|096|O|OVERDOSE:  This medication patch may be harmful if chewed or||
2534|097|O|swallowed. If someone has overdosed, remove the patch if||
2534|098|O|possible. For serious symptoms such as passing out or trouble||
2534|099|O|breathing, call 911. Otherwise, call a poison control center||
2534|100|O|right away. US residents can call 1-800-222-1222. Canada||
2534|101|O|residents can call 1-844-764-7669.||
2534|102|B|||
2534|103|N|NOTES:  Keep all medical and lab appointments.||
2534|104|B|||
2534|105|D|MISSED DOSE:  Not applicable.||
2534|106|B|||
2534|107|R|STORAGE:  Not applicable. This medication is given in a clinic or||
2534|108|R|doctor's office and will not be stored at home.||
2534|109|B|||
2534|110|A|Information last revised May 2024.||
2534|111|A|Copyright(c) 2025 First Databank, Inc.||
2534|112|B|||
2535|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2535|002|Z|does NOT have all possible information about this product. This||
2535|003|Z|information does not assure that this product is safe, effective,||
2535|004|Z|or appropriate for you. This information is not individual||
2535|005|Z|medical advice and does not substitute for the advice of your||
2535|006|Z|health care professional. Always ask your health care||
2535|007|Z|professional for complete information about this product and your||
2535|008|Z|specific health needs.||
2535|009|B|||
2535|010|T|MOMELOTINIB - ORAL||
2535|011|F|(MOE-me-LOE-ti-nib)||
2535|012|B|||
2535|013|C|COMMON BRAND NAME(S): Ojjaara||
2535|014|B|||
2535|015|U|USES:  This medication is used to treat a certain type of cancer||
2535|016|U|(myelofibrosis) in people with anemia (low red blood cell count).||
2535|017|U|Momelotinib belongs to a class of drugs known as kinase||
2535|018|U|inhibitors. It works by blocking your body from producing||
2535|019|U|substances called growth factors. Growth factors cause cells to||
2535|020|U|grow and divide, and cause the blood cell and spleen problems||
2535|021|U|found in myelofibrosis. Though not a cure for this condition,||
2535|022|U|momelotinib may help with some of the symptoms, including||
2535|023|U|abdominal discomfort, pain under left ribs, early feelings of||
2535|024|U|fullness from meals, night sweats, itching, and bone/muscle pain.||
2535|025|B|||
2535|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2535|027|H|from your pharmacist before you start taking momelotinib and each||
2535|028|H|time you get a refill. If you have any questions, ask your doctor||
2535|029|H|or pharmacist.||
2535|030|H|   Take this medication by mouth with or without food as directed||
2535|031|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2535|032|H|not crush or chew the tablets. The dosage is based on your||
2535|033|H|medical condition and response to treatment.||
2535|034|H|   Use this medication regularly to get the most benefit from it.||
2535|035|H|To help you remember, take it at the same time each day.||
2535|036|H|   Do not increase your dose or use this drug more often or for||
2535|037|H|longer than prescribed. Your condition will not improve any||
2535|038|H|faster, and your risk of side effects will increase.||
2535|039|B|||
2535|040|S|SIDE EFFECTS:  Dizziness, diarrhea, nausea, vomiting, stomach||
2535|041|S|pain, or tiredness may occur. If any of these effects last or get||
2535|042|S|worse, tell your doctor or pharmacist promptly.||
2535|043|S|   People using this medication may have serious side effects.||
2535|044|S|However, you have been prescribed this drug because your doctor||
2535|045|S|has judged that the benefit to you is greater than the risk of||
2535|046|S|side effects. Careful monitoring by your doctor may decrease your||
2535|047|S|risk.||
2535|048|S|   Tell your doctor right away if you have any serious side||
2535|049|S|effects, including: signs of liver problems (such as||
2535|050|S|nausea/vomiting that doesn't stop, loss of appetite,||
2535|051|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
2535|052|S|bruising/bleeding.||
2535|053|S|   This medication may lower your ability to fight infections.||
2535|054|S|This may make you more likely to get a serious (rarely fatal)||
2535|055|S|infection or make any infection you have worse. Tell your doctor||
2535|056|S|right away if you have any signs of infection (such as sore||
2535|057|S|throat that doesn't go away, fever, chills).||
2535|058|S|   Another medication similar to momelotinib has caused serious||
2535|059|S|(possibly fatal) side effects, including heart problems, blood||
2535|060|S|clots, and cancer (such as lymphoma). Before using momelotinib,||
2535|061|S|tell your doctor or pharmacist if you have a history of heart||
2535|062|S|disease, stroke, or cancer, or if you have any risk factors for||
2535|063|S|heart disease (such as high blood pressure, diabetes, previous||
2535|064|S|blood clots, high cholesterol, smoking or history of smoking).||
2535|065|S|Discuss the risks and benefits of treatment with your doctor. Get||
2535|066|S|medical help right away if you have symptoms such as shortness of||
2535|067|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
2535|068|S|sweating, sudden dizziness/fainting, pain/swelling/warmth in the||
2535|069|S|groin/calf, sudden/severe headaches, trouble speaking, or||
2535|070|S|weakness on one side of the body.||
2535|071|S|   A very serious allergic reaction to this drug is rare.||
2535|072|S|However, get medical help right away if you notice any symptoms||
2535|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2535|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2535|075|S|breathing.||
2535|076|S|   This is not a complete list of possible side effects. If you||
2535|077|S|notice other effects not listed above, contact your doctor or||
2535|078|S|pharmacist.||
2535|079|S|   In the US -||
2535|080|S|   Call your doctor for medical advice about side effects. You||
2535|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2535|082|S|www.fda.gov/medwatch.||
2535|083|S|   In Canada - Call your doctor for medical advice about side||
2535|084|S|effects. You may report side effects to Health Canada at||
2535|085|S|1-866-234-2345.||
2535|086|B|||
2535|087|P|PRECAUTIONS:  See also Side Effects section.||
2535|088|P|   Before taking momelotinib, tell your doctor or pharmacist if||
2535|089|P|you are allergic to it; or if you have any other allergies. This||
2535|090|P|product may contain inactive ingredients, which can cause||
2535|091|P|allergic reactions or other problems. Talk to your pharmacist for||
2535|092|P|more details.||
2535|093|P|   Before using this medication, tell your doctor or pharmacist||
2535|094|P|your medical history, especially of: liver disease, current/past||
2535|095|P|infections.||
2535|096|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2535|097|P|can make you more dizzy. Do not drive, use machinery, or do||
2535|098|P|anything that needs alertness until you can do it safely. Limit||
2535|099|P|alcoholic beverages. Talk to your doctor if you are using||
2535|100|P|marijuana (cannabis).||
2535|101|P|   Momelotinib can make you more likely to get infections or may||
2535|102|P|make current infections worse. Stay away from anyone who has an||
2535|103|P|infection that may easily spread (such as chickenpox, COVID-19,||
2535|104|P|measles, flu). Talk to your doctor if you have been exposed to an||
2535|105|P|infection or for more details.||
2535|106|P|   Tell your health care professional that you are using||
2535|107|P|momelotinib before having any immunizations/vaccinations. Avoid||
2535|108|P|contact with people who have recently received live vaccines||
2535|109|P|(such as flu vaccine inhaled through the nose).||
2535|110|P|   To lower the chance of getting cut, bruised, or injured, use||
2535|111|P|caution with sharp objects like razors and nail cutters, and||
2535|112|P|avoid activities such as contact sports.||
2535|113|P|   Before having surgery, tell your doctor or dentist about all||
2535|114|P|the products you use (including prescription drugs,||
2535|115|P|nonprescription drugs, and herbal products).||
2535|116|P|   Tell your doctor if you are pregnant or plan to become||
2535|117|P|pregnant. You should not become pregnant while using momelotinib.||
2535|118|P|Momelotinib may harm an unborn baby. Ask about reliable forms of||
2535|119|P|birth control while using this medication and for 1 week after||
2535|120|P|the last dose. If you become pregnant, talk to your doctor right||
2535|121|P|away about the risks and benefits of this medication.||
2535|122|P|   It is unknown if this medication passes into breast milk.||
2535|123|P|Because of the possible risk to the infant, breastfeeding is not||
2535|124|P|recommended while using this medication and for 1 week after the||
2535|125|P|last dose. Consult your doctor before breastfeeding.||
2535|126|B|||
2535|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2535|128|I|medications work or increase your risk for serious side effects.||
2535|129|I|This document does not contain all possible drug interactions.||
2535|130|I|Keep a list of all the products you use (including||
2535|131|I|prescription/nonprescription drugs and herbal products) and share||
2535|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
2535|133|I|the dosage of any medicines without your doctor's approval.||
2535|134|B|||
2535|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2535|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2535|137|O|poison control center right away. US residents can call||
2535|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2535|139|B|||
2535|140|N|NOTES:  Do not share this medication with others.||
2535|141|N|   Lab and/or medical tests (such as complete blood counts, liver||
2535|142|N|function) should be done before you start taking this medication||
2535|143|N|and while you are taking it. Keep all medical and lab||
2535|144|N|appointments. Consult your doctor for more details.||
2535|145|B|||
2535|146|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2535|147|D|next dose at the regular time. Do not double the dose to catch||
2535|148|D|up.||
2535|149|B|||
2535|150|R|STORAGE:  Store in the original container at room temperature||
2535|151|R|away from light and moisture. Do not store in the bathroom. Keep||
2535|152|R|the drying agent (desiccant) in the container. Tightly close the||
2535|153|R|container when not in use. Keep all medications away from||
2535|154|R|children and pets.||
2535|155|R|   Do not flush medications down the toilet or pour them into a||
2535|156|R|drain unless instructed to do so. Properly discard this product||
2535|157|R|when it is expired or no longer needed. Consult your pharmacist||
2535|158|R|or local waste disposal company.||
2535|159|B|||
2535|160|M|MEDICAL ALERT:  Your condition can cause complications in a||
2535|161|M|medical emergency. For information about enrolling in MedicAlert,||
2535|162|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2535|163|B|||
2535|164|A|Information last revised April 2025.||
2535|165|A|Copyright(c) 2025 First Databank, Inc.||
2535|166|B|||
2536|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2536|002|Z|does NOT have all possible information about this product. This||
2536|003|Z|information does not assure that this product is safe, effective,||
2536|004|Z|or appropriate for you. This information is not individual||
2536|005|Z|medical advice and does not substitute for the advice of your||
2536|006|Z|health care professional. Always ask your health care||
2536|007|Z|professional for complete information about this product and your||
2536|008|Z|specific health needs.||
2536|009|B|||
2536|010|T|MOTIXAFORTIDE - INJECTION||
2536|011|B|||
2536|012|C|COMMON BRAND NAME(S): Aphexda||
2536|013|B|||
2536|014|U|USES:  Motixafortide is used by people with a certain type of||
2536|015|U|cancer (multiple myeloma) to prepare for stem cell transplant.||
2536|016|U|Stem cells, which are found mainly in the bone marrow, turn into||
2536|017|U|red blood cells, white blood cells, and platelets. Motixafortide||
2536|018|U|is used to help stem cells move from the bone marrow to the||
2536|019|U|bloodstream so that the cells can be collected and stored. The||
2536|020|U|stem cells are then given back to you by infusion after||
2536|021|U|chemotherapy or radiation.||
2536|022|B|||
2536|023|H|HOW TO USE:  This medication is given by injection under the skin||
2536|024|H|by a health care professional. It is given as directed by your||
2536|025|H|doctor, usually 10 to 14 hours before the blood filtering||
2536|026|H|procedure.||
2536|027|H|   The dosage is based on your medical condition and weight.||
2536|028|H|   Motixafortide may cause serious (sometimes fatal) allergic||
2536|029|H|reactions, usually within 30 minutes after the injection. To help||
2536|030|H|prevent these side effects, your doctor will prescribe other||
2536|031|H|medications (such as diphenhydramine, montelukast, and an H2||
2536|032|H|blocker) for you to receive before each dose. Carefully follow||
2536|033|H|your doctor's instructions. Your health care professional will||
2536|034|H|also closely monitor you for 1 hour after the injection. Get||
2536|035|H|medical help right away if you notice any signs of a serious||
2536|036|H|allergic reaction such as rash, itching/swelling (especially of||
2536|037|H|the face, tongue, throat), severe dizziness, trouble breathing,||
2536|038|H|flushing, chills, nausea, or vomiting.||
2536|039|B|||
2536|040|S|SIDE EFFECTS:  See also How to Use section.||
2536|041|S|   Pain, redness, or itching at the injection site may occur. If||
2536|042|S|any of these effects last or get worse, tell your doctor or||
2536|043|S|pharmacist promptly.||
2536|044|S|   Remember that this medication has been prescribed because your||
2536|045|S|doctor has judged that the benefit to you is greater than the||
2536|046|S|risk of side effects. Many people using this medication do not||
2536|047|S|have serious side effects.||
2536|048|S|   Motixafortide can commonly cause a rash that is usually not||
2536|049|S|serious. However, you may not be able to tell it apart from a||
2536|050|S|rare rash that could be a sign of a severe reaction. Get medical||
2536|051|S|help right away if you develop any rash.||
2536|052|S|   This is not a complete list of possible side effects. If you||
2536|053|S|notice other effects not listed above, contact your doctor or||
2536|054|S|pharmacist.||
2536|055|S|   In the US -||
2536|056|S|   Call your doctor for medical advice about side effects. You||
2536|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2536|058|S|www.fda.gov/medwatch.||
2536|059|S|   In Canada - Call your doctor for medical advice about side||
2536|060|S|effects. You may report side effects to Health Canada at||
2536|061|S|1-866-234-2345.||
2536|062|B|||
2536|063|P|PRECAUTIONS:  Before using motixafortide, tell your doctor or||
2536|064|P|pharmacist if you are allergic to it; or if you have any other||
2536|065|P|allergies. This product may contain inactive ingredients, which||
2536|066|P|can cause allergic reactions or other problems. Talk to your||
2536|067|P|pharmacist for more details.||
2536|068|P|   Before using this medication, tell your doctor or pharmacist||
2536|069|P|your medical history, especially of: leukemia.||
2536|070|P|   Before having surgery, tell your doctor or dentist about all||
2536|071|P|the products you use (including prescription drugs,||
2536|072|P|nonprescription drugs, and herbal products).||
2536|073|P|   Tell your doctor if you are pregnant or plan to become||
2536|074|P|pregnant. You should not become pregnant while using||
2536|075|P|motixafortide. Motixafortide may harm an unborn baby. Your doctor||
2536|076|P|should order a pregnancy test before you start this medication.||
2536|077|P|Ask about reliable forms of birth control while using this||
2536|078|P|medication and for 8 days after the last dose. If you become||
2536|079|P|pregnant, talk to your doctor right away about the risks and||
2536|080|P|benefits of this medication.||
2536|081|P|   It is unknown if this medication passes into breast milk.||
2536|082|P|Because of the possible risk to the infant, breastfeeding is not||
2536|083|P|recommended while using this medication and for 8 days after the||
2536|084|P|last dose. Consult your doctor before breastfeeding.||
2536|085|B|||
2536|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2536|087|I|medications work or increase your risk for serious side effects.||
2536|088|I|This document does not contain all possible drug interactions.||
2536|089|I|Keep a list of all the products you use (including||
2536|090|I|prescription/nonprescription drugs and herbal products) and share||
2536|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2536|092|I|the dosage of any medicines without your doctor's approval.||
2536|093|B|||
2536|094|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2536|095|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2536|096|O|poison control center right away. US residents can call||
2536|097|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2536|098|B|||
2536|099|N|NOTES:  Lab and/or medical tests (such as complete blood count)||
2536|100|N|should be done while you are using this medication. Keep all||
2536|101|N|medical and lab appointments. Consult your doctor for more||
2536|102|N|details.||
2536|103|B|||
2536|104|D|MISSED DOSE:  It is important to get each dose of this medication||
2536|105|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2536|106|D|right away for a new dosing schedule.||
2536|107|B|||
2536|108|R|STORAGE:  Not applicable. This medication is given in a hospital||
2536|109|R|or clinic or doctor's office and will not be stored at home.||
2536|110|B|||
2536|111|A|Information last revised May 2024.||
2536|112|A|Copyright(c) 2025 First Databank, Inc.||
2536|113|B|||
2537|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2537|002|Z|does NOT have all possible information about this product. This||
2537|003|Z|information does not assure that this product is safe, effective,||
2537|004|Z|or appropriate for you. This information is not individual||
2537|005|Z|medical advice and does not substitute for the advice of your||
2537|006|Z|health care professional. Always ask your health care||
2537|007|Z|professional for complete information about this product and your||
2537|008|Z|specific health needs.||
2537|009|B|||
2537|010|T|LUTETIUM LU 177 DOTATATE - INJECTION||
2537|011|B|||
2537|012|C|COMMON BRAND NAME(S): Lutathera||
2537|013|B|||
2537|014|U|USES:  This medication is used to treat certain types of tumors||
2537|015|U|(gastroenteropancreatic neuroendocrine tumors - GEP-NETs).||
2537|016|U|Lutetium Lu 177 dotatate is a radioactive drug. It works by||
2537|017|U|attaching to certain tumor cells and causing them to die.||
2537|018|B|||
2537|019|H|HOW TO USE:  This medication is given by injection into a vein by||
2537|020|H|a health care professional. It is given as directed by your||
2537|021|H|doctor, usually once every 8 weeks for 4 doses. The dosage is||
2537|022|H|based on your medical condition, lab tests, and response to||
2537|023|H|treatment.||
2537|024|H|   Follow your doctor's instructions about the other medications||
2537|025|H|(such as octreotide) you may need to use with this product.||
2537|026|H|   Drink plenty of fluids before, during, and after treatment||
2537|027|H|with this medication and urinate as often as possible to lessen||
2537|028|H|the risk of kidney damage. Ask your doctor for more details.||
2537|029|H|   During and after receiving this medication, follow your||
2537|030|H|doctor's instructions on how to reduce radiation exposure to||
2537|031|H|others.||
2537|032|B|||
2537|033|S|SIDE EFFECTS:  Dizziness, headache, nausea/vomiting,||
2537|034|S|diarrhea/constipation, change in how food tastes, hair loss, or||
2537|035|S|decreased appetite may occur. If any of these effects last or get||
2537|036|S|worse, tell your doctor or pharmacist promptly.||
2537|037|S|   People using this medication may have serious side effects.||
2537|038|S|However, you have been prescribed this drug because your doctor||
2537|039|S|has judged that the benefit to you is greater than the risk of||
2537|040|S|side effects. Careful monitoring by your doctor may decrease your||
2537|041|S|risk.||
2537|042|S|   Tell your doctor right away if you have any serious side||
2537|043|S|effects, including: signs of kidney damage (such as change in||
2537|044|S|amount of urine), signs of liver disease (such as nausea/vomiting||
2537|045|S|that doesn't stop, stomach/abdominal pain, yellowing eyes/skin,||
2537|046|S|dark urine), flushing, shortness of breath, swelling||
2537|047|S|hands/ankles/feet, muscle pain, fast/irregular heartbeat,||
2537|048|S|mental/mood changes (such as anxiety).||
2537|049|S|   This medication decreases bone marrow function, an effect that||
2537|050|S|may lead to a low number of blood cells such as red cells, white||
2537|051|S|cells, and platelets. This effect can cause anemia, decrease your||
2537|052|S|body's ability to fight an infection, or cause easy||
2537|053|S|bruising/bleeding. Tell your doctor right away if you develop any||
2537|054|S|of the following unlikely symptoms: unusual tiredness, pale skin,||
2537|055|S|signs of infection (such as sore throat that doesn't go away,||
2537|056|S|fever, chills, painful/burning urination), easy||
2537|057|S|bruising/bleeding.||
2537|058|S|   Some people treated with this medication may rarely get other||
2537|059|S|cancers (such as leukemia). Consult your doctor for more details.||
2537|060|S|   A very serious allergic reaction to this drug is rare.||
2537|061|S|However, get medical help right away if you notice any symptoms||
2537|062|S|of a serious allergic reaction, including: rash, itching/swelling||
2537|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2537|064|S|breathing.||
2537|065|S|   This is not a complete list of possible side effects. If you||
2537|066|S|notice other effects not listed above, contact your doctor or||
2537|067|S|pharmacist.||
2537|068|S|   In the US -||
2537|069|S|   Call your doctor for medical advice about side effects. You||
2537|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2537|071|S|www.fda.gov/medwatch.||
2537|072|S|   In Canada - Call your doctor for medical advice about side||
2537|073|S|effects. You may report side effects to Health Canada at||
2537|074|S|1-866-234-2345.||
2537|075|B|||
2537|076|P|PRECAUTIONS:  Before using lutetium Lu 177 dotatate, tell your||
2537|077|P|doctor or pharmacist if you are allergic to it; or if you have||
2537|078|P|any other allergies. This product may contain inactive||
2537|079|P|ingredients, which can cause allergic reactions or other||
2537|080|P|problems. Talk to your pharmacist for more details.||
2537|081|P|   Before using this medication, tell your doctor or pharmacist||
2537|082|P|your medical history, especially of: kidney problems, liver||
2537|083|P|problems (such as cancer).||
2537|084|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2537|085|P|can make you more dizzy. Do not drive, use machinery, or do||
2537|086|P|anything that needs alertness until you can do it safely. Limit||
2537|087|P|alcoholic beverages. Talk to your doctor if you are using||
2537|088|P|marijuana (cannabis).||
2537|089|P|   This medication can make you more likely to get infections or||
2537|090|P|may make current infections worse. Stay away from anyone who has||
2537|091|P|an infection that may easily spread (such as chickenpox,||
2537|092|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2537|093|P|exposed to an infection or for more details.||
2537|094|P|   Tell your health care professional that you are using lutetium||
2537|095|P|Lu 177 dotatate before having any immunizations/vaccinations.||
2537|096|P|Avoid contact with people who have recently received live||
2537|097|P|vaccines (such as flu vaccine inhaled through the nose).||
2537|098|P|   To lower the chance of getting cut, bruised, or injured, use||
2537|099|P|caution with sharp objects like razors and nail cutters, and||
2537|100|P|avoid activities such as contact sports.||
2537|101|P|   Before having surgery, tell your doctor or dentist about all||
2537|102|P|the products you use (including prescription drugs,||
2537|103|P|nonprescription drugs, and herbal products).||
2537|104|P|   This medication may affect the ability to have children. Talk||
2537|105|P|to your doctor for details.||
2537|106|P|   Tell your doctor if you are pregnant or plan to become||
2537|107|P|pregnant. You should not become pregnant while using lutetium Lu||
2537|108|P|177 dotatate. Lutetium Lu 177 dotatate may harm an unborn baby.||
2537|109|P|Your doctor should order a pregnancy test before you start this||
2537|110|P|medication. Women using this medication should ask about reliable||
2537|111|P|forms of birth control during treatment and for 7 months after||
2537|112|P|the last dose. Men using this medication should ask about||
2537|113|P|reliable forms of birth control during treatment and for 4 months||
2537|114|P|after the last dose. If you or your partner becomes pregnant,||
2537|115|P|talk to your doctor right away about the risks and benefits of||
2537|116|P|this medication.||
2537|117|P|   It is unknown if this medication passes into breast milk.||
2537|118|P|Because of the possible risk to the infant, breastfeeding is not||
2537|119|P|recommended while using this medication and for 2.5 months after||
2537|120|P|the last dose. Consult your doctor before breastfeeding.||
2537|121|B|||
2537|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2537|123|I|medications work or increase your risk for serious side effects.||
2537|124|I|This document does not contain all possible drug interactions.||
2537|125|I|Keep a list of all the products you use (including||
2537|126|I|prescription/nonprescription drugs and herbal products) and share||
2537|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
2537|128|I|the dosage of any medicines without your doctor's approval.||
2537|129|B|||
2537|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2537|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2537|132|O|poison control center right away. US residents can call||
2537|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2537|134|B|||
2537|135|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2537|136|N|kidney/liver function, blood mineral levels, blood sugar) should||
2537|137|N|be done before you start receiving this medication and while you||
2537|138|N|are using it. Keep all medical and lab appointments.||
2537|139|B|||
2537|140|D|MISSED DOSE:  It is important to get each dose of this medication||
2537|141|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2537|142|D|right away for a new dosing schedule. Do not double the dose to||
2537|143|D|catch up.||
2537|144|B|||
2537|145|R|STORAGE:  Not applicable. This medication is given in a hospital||
2537|146|R|or clinic or doctor's office and will not be stored at home.||
2537|147|B|||
2537|148|M|MEDICAL ALERT:  Your condition can cause complications in a||
2537|149|M|medical emergency. For information about enrolling in MedicAlert,||
2537|150|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2537|151|B|||
2537|152|A|Information last revised April 2025.||
2537|153|A|Copyright(c) 2025 First Databank, Inc.||
2537|154|B|||
2538|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2538|002|Z|does NOT have all possible information about this product. This||
2538|003|Z|information does not assure that this product is safe, effective,||
2538|004|Z|or appropriate for you. This information is not individual||
2538|005|Z|medical advice and does not substitute for the advice of your||
2538|006|Z|health care professional. Always ask your health care||
2538|007|Z|professional for complete information about this product and your||
2538|008|Z|specific health needs.||
2538|009|B|||
2538|010|T|CIPAGLUCOSIDASE ALFA - INJECTION||
2538|011|F|(SIP-a-gloo-KOE-si-dase Al-fa)||
2538|012|B|||
2538|013|C|COMMON BRAND NAME(S): Pombiliti||
2538|014|B|||
2538|015|W|WARNING:  Infusion reactions or serious (sometimes fatal)||
2538|016|W|allergic reactions may happen during the infusion of||
2538|017|W|cipaglucosidase alfa and for a short time afterward. Your doctor||
2538|018|W|may prescribe other medications (such as a fever reducer,||
2538|019|W|antihistamines, corticosteroids) before each treatment to help||
2538|020|W|prevent these side effects. Get medical help right away if you||
2538|021|W|have any symptoms of a serious allergic reaction or infusion||
2538|022|W|reactions such as rash, itching/swelling (especially of the||
2538|023|W|face/tongue/throat), severe dizziness, trouble breathing, chills,||
2538|024|W|or flushing. Your doctor may slow down or stop your treatment for||
2538|025|W|some time.||
2538|026|W|   Before starting treatment with this medication, tell your||
2538|027|W|doctor if you have a history of heart problems (such as heart||
2538|028|W|failure), breathing problems (such as fluid in the lungs), or||
2538|029|W|swelling. These problems may get worse during the infusion. Your||
2538|030|W|doctor or nurse may monitor you for longer periods after your||
2538|031|W|infusion.||
2538|032|B|||
2538|033|U|USES:  Cipaglucosidase alfa is used in combination with another||
2538|034|U|medication (miglustat) to treat a certain inherited condition||
2538|035|U|(Pompe disease). It works by breaking down a certain substance||
2538|036|U|(glycogen) that builds up in the body due to this condition.||
2538|037|U|Decreasing glycogen in the body can help improve symptoms of||
2538|038|U|Pompe disease such as muscle weakness, heart problems, and||
2538|039|U|breathing problems.||
2538|040|U|   This medication must be used with miglustat because it helps||
2538|041|U|cipaglucosidase alfa stay active in the blood which helps it work||
2538|042|U|better.||
2538|043|B|||
2538|044|H|HOW TO USE:  See also Warning section.||
2538|045|H|   This medication is given as directed by your doctor, usually||
2538|046|H|once every other week, 1 hour after you take miglustat. It is||
2538|047|H|injected slowly into a vein, usually over 4 hours, by a health||
2538|048|H|care professional.||
2538|049|H|   The dosage is based on your medical condition, weight, and||
2538|050|H|response to treatment.||
2538|051|H|   Use this medication regularly to get the most benefit from it.||
2538|052|H|To help you remember, mark your calendar with a reminder. If you||
2538|053|H|miss your dose of miglustat or your infusion is not started||
2538|054|H|within 3 hours of taking miglustat, your infusion will need to be||
2538|055|H|rescheduled. Ask your doctor or pharmacist right away for a new||
2538|056|H|dosing schedule.||
2538|057|H|   Tell your doctor if your condition does not get better or if||
2538|058|H|it gets worse.||
2538|059|B|||
2538|060|S|SIDE EFFECTS:  See also Warning section.||
2538|061|S|   Headache, diarrhea, or dizziness may occur. If any of these||
2538|062|S|effects last or get worse, tell your doctor or pharmacist||
2538|063|S|promptly.||
2538|064|S|   Remember that this medication has been prescribed because your||
2538|065|S|doctor has judged that the benefit to you is greater than the||
2538|066|S|risk of side effects. Many people using this medication do not||
2538|067|S|have serious side effects.||
2538|068|S|   This is not a complete list of possible side effects. If you||
2538|069|S|notice other effects not listed above, contact your doctor or||
2538|070|S|pharmacist.||
2538|071|S|   In the US -||
2538|072|S|   Call your doctor for medical advice about side effects. You||
2538|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2538|074|S|www.fda.gov/medwatch.||
2538|075|S|   In Canada - Call your doctor for medical advice about side||
2538|076|S|effects. You may report side effects to Health Canada at||
2538|077|S|1-866-234-2345.||
2538|078|B|||
2538|079|P|PRECAUTIONS:  See also Warning section.||
2538|080|P|   Before using cipaglucosidase alfa, tell your doctor or||
2538|081|P|pharmacist if you are allergic to it; or if you have any other||
2538|082|P|allergies. This product may contain inactive ingredients, which||
2538|083|P|can cause allergic reactions or other problems. Talk to your||
2538|084|P|pharmacist for more details.||
2538|085|P|   Before using this medication, tell your doctor or pharmacist||
2538|086|P|your medical history.||
2538|087|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2538|088|P|can make you more dizzy. Do not drive, use machinery, or do||
2538|089|P|anything that needs alertness until you can do it safely. Limit||
2538|090|P|alcoholic beverages. Talk to your doctor if you are using||
2538|091|P|marijuana (cannabis).||
2538|092|P|   Before having surgery, tell your doctor or dentist about all||
2538|093|P|the products you use (including prescription drugs,||
2538|094|P|nonprescription drugs, and herbal products).||
2538|095|P|   When used in combination with miglustat, this medication must||
2538|096|P|not be used during pregnancy. It may harm an unborn baby. Your||
2538|097|P|doctor should order a pregnancy test before you start this||
2538|098|P|medication. Discuss the use of reliable forms of birth control||
2538|099|P|while using this medication and for at least 60 days after the||
2538|100|P|last dose. If you become pregnant or think you may be pregnant,||
2538|101|P|tell your doctor right away.||
2538|102|P|   It is unknown if this medication passes into breast milk.||
2538|103|P|Because of the possible risk to the infant, breastfeeding is not||
2538|104|P|recommended while using this medication. Consult your doctor||
2538|105|P|before breastfeeding.||
2538|106|B|||
2538|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2538|108|I|medications work or increase your risk for serious side effects.||
2538|109|I|This document does not contain all possible drug interactions.||
2538|110|I|Keep a list of all the products you use (including||
2538|111|I|prescription/nonprescription drugs and herbal products) and share||
2538|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2538|113|I|the dosage of any medicines without your doctor's approval.||
2538|114|B|||
2538|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2538|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2538|117|O|poison control center right away. US residents can call||
2538|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2538|119|B|||
2538|120|N|NOTES:  Keep all medical and lab appointments.||
2538|121|B|||
2538|122|D|MISSED DOSE:  See also How to Use section.||
2538|123|D|   It is important to get each dose of this medication as||
2538|124|D|scheduled. If you miss a dose, ask your doctor or pharmacist||
2538|125|D|right away for a new dosing schedule.||
2538|126|B|||
2538|127|R|STORAGE:  Not applicable. This medication is given in a hospital||
2538|128|R|or clinic or doctor's office and will not be stored at home.||
2538|129|B|||
2538|130|A|Information last revised October 2024.||
2538|131|A|Copyright(c) 2025 First Databank, Inc.||
2538|132|B|||
2539|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2539|002|Z|does NOT have all possible information about this product. This||
2539|003|Z|information does not assure that this product is safe, effective,||
2539|004|Z|or appropriate for you. This information is not individual||
2539|005|Z|medical advice and does not substitute for the advice of your||
2539|006|Z|health care professional. Always ask your health care||
2539|007|Z|professional for complete information about this product and your||
2539|008|Z|specific health needs.||
2539|009|B|||
2539|010|T|MIGLUSTAT 65 MG - ORAL||
2539|011|F|(mi-GLOO-stat)||
2539|012|B|||
2539|013|C|COMMON BRAND NAME(S): Opfolda||
2539|014|B|||
2539|015|U|USES:  Miglustat is used in combination with another medication||
2539|016|U|(cipaglucosidase alfa) to treat a certain inherited condition||
2539|017|U|(Pompe disease). Cipaglucosidase alfa works by breaking down a||
2539|018|U|certain substance (glycogen) that builds up in the body due to||
2539|019|U|this condition. Miglustat helps cipaglucosidase alfa stay active||
2539|020|U|in the blood which helps it work better.||
2539|021|U|   Miglustat must be used with cipaglucosidase alfa because it||
2539|022|U|does not decrease glycogen levels when used alone.||
2539|023|B|||
2539|024|V|OTHER USES:  This section contains uses of this drug that are not||
2539|025|V|listed in the approved professional labeling for the drug but||
2539|026|V|that may be prescribed by your health care professional. Use this||
2539|027|V|drug for a condition that is listed in this section only if it||
2539|028|V|has been so prescribed by your health care professional.||
2539|029|V|   Miglustat is also available in another strength and other||
2539|030|V|brands for a certain rare genetic problem (Gaucher's disease). Do||
2539|031|V|not take this medication with any other product that contains||
2539|032|V|miglustat.||
2539|033|B|||
2539|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2539|035|H|from your pharmacist before you start taking miglustat and each||
2539|036|H|time you get a refill. If you have any questions, ask your doctor||
2539|037|H|or pharmacist.||
2539|038|H|   Take this medication by mouth on an empty stomach as directed||
2539|039|H|by your doctor, usually once every other week, 1 hour before the||
2539|040|H|cipaglucosidase alfa infusion. Swallow the capsules whole with||
2539|041|H|only unsweetened beverages (such as water, or tea or coffee with||
2539|042|H|no cream, sugar, or sweeteners). Do not drink other beverages or||
2539|043|H|eat food for at least 2 hours before and 2 hours after taking||
2539|044|H|this medication.||
2539|045|H|   The dosage is based on your medical condition, weight, and||
2539|046|H|response to treatment.||
2539|047|H|   Use this medication regularly to get the most benefit from it.||
2539|048|H|To help you remember, mark your calendar with a reminder. If you||
2539|049|H|miss your dose of miglustat, ask your doctor or pharmacist right||
2539|050|H|away for a new dosing schedule. Your cipaglucosidase alfa||
2539|051|H|infusion will also need to be rescheduled.||
2539|052|H|   Do not increase your dose or use this drug more often or for||
2539|053|H|longer than prescribed. Your condition will not improve any||
2539|054|H|faster, and your risk of side effects will increase.||
2539|055|H|   Tell your doctor if your condition does not get better or if||
2539|056|H|it gets worse.||
2539|057|B|||
2539|058|S|SIDE EFFECTS:  Headache, diarrhea, or dizziness may occur. If any||
2539|059|S|of these effects last or get worse, tell your doctor or||
2539|060|S|pharmacist promptly.||
2539|061|S|   Remember that this medication has been prescribed because your||
2539|062|S|doctor has judged that the benefit to you is greater than the||
2539|063|S|risk of side effects. Many people using this medication do not||
2539|064|S|have serious side effects.||
2539|065|S|   A very serious allergic reaction to this drug is rare.||
2539|066|S|However, get medical help right away if you notice any symptoms||
2539|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2539|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2539|069|S|breathing.||
2539|070|S|   This is not a complete list of possible side effects. If you||
2539|071|S|notice other effects not listed above, contact your doctor or||
2539|072|S|pharmacist.||
2539|073|S|   In the US -||
2539|074|S|   Call your doctor for medical advice about side effects. You||
2539|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2539|076|S|www.fda.gov/medwatch.||
2539|077|S|   In Canada - Call your doctor for medical advice about side||
2539|078|S|effects. You may report side effects to Health Canada at||
2539|079|S|1-866-234-2345.||
2539|080|B|||
2539|081|P|PRECAUTIONS:  Before taking miglustat, tell your doctor or||
2539|082|P|pharmacist if you are allergic to it; or if you have any other||
2539|083|P|allergies. This product may contain inactive ingredients, which||
2539|084|P|can cause allergic reactions or other problems. Talk to your||
2539|085|P|pharmacist for more details.||
2539|086|P|   Before using this medication, tell your doctor or pharmacist||
2539|087|P|your medical history, especially of: kidney disease.||
2539|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2539|089|P|can make you more dizzy. Do not drive, use machinery, or do||
2539|090|P|anything that needs alertness until you can do it safely. Limit||
2539|091|P|alcoholic beverages. Talk to your doctor if you are using||
2539|092|P|marijuana (cannabis).||
2539|093|P|   Before having surgery, tell your doctor or dentist about all||
2539|094|P|the products you use (including prescription drugs,||
2539|095|P|nonprescription drugs, and herbal products).||
2539|096|P|   When taken in combination with cipaglucosidase alfa, this||
2539|097|P|medication must not be used during pregnancy. It may harm an||
2539|098|P|unborn baby. Your doctor should order a pregnancy test before you||
2539|099|P|start this medication. Discuss the use of reliable forms of birth||
2539|100|P|control while using this medication and for at least 60 days||
2539|101|P|after the last dose. If you become pregnant or think you may be||
2539|102|P|pregnant, tell your doctor right away.||
2539|103|P|   It is unknown if this medication passes into breast milk.||
2539|104|P|Because of the possible risk to the infant, breastfeeding is not||
2539|105|P|recommended while using this medication. Consult your doctor||
2539|106|P|before breastfeeding.||
2539|107|B|||
2539|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2539|109|I|medications work or increase your risk for serious side effects.||
2539|110|I|This document does not contain all possible drug interactions.||
2539|111|I|Keep a list of all the products you use (including||
2539|112|I|prescription/nonprescription drugs and herbal products) and share||
2539|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
2539|114|I|the dosage of any medicines without your doctor's approval.||
2539|115|B|||
2539|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2539|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2539|118|O|poison control center right away. US residents can call||
2539|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2539|120|B|||
2539|121|N|NOTES:  Do not share this medication with others.||
2539|122|N|   Lab and/or medical tests (such as kidney function) should be||
2539|123|N|done while you are taking this medication. Keep all medical and||
2539|124|N|lab appointments. Consult your doctor for more details.||
2539|125|B|||
2539|126|D|MISSED DOSE:  See also How to Use section.||
2539|127|D|   It is important to take each dose of this medication as||
2539|128|D|scheduled. If you miss a dose, ask your doctor or pharmacist||
2539|129|D|right away for a new dosing schedule.||
2539|130|B|||
2539|131|R|STORAGE:  Store in the original container at room temperature||
2539|132|R|away from light and moisture. Do not store in the bathroom. Keep||
2539|133|R|all medications away from children and pets.||
2539|134|R|   Do not flush medications down the toilet or pour them into a||
2539|135|R|drain unless instructed to do so. Properly discard this product||
2539|136|R|when it is expired or no longer needed. Consult your pharmacist||
2539|137|R|or local waste disposal company.||
2539|138|B|||
2539|139|A|Information last revised October 2024.||
2539|140|A|Copyright(c) 2025 First Databank, Inc.||
2539|141|B|||
2540|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2540|002|Z|does NOT have all possible information about this product. This||
2540|003|Z|information does not assure that this product is safe, effective,||
2540|004|Z|or appropriate for you. This information is not individual||
2540|005|Z|medical advice and does not substitute for the advice of your||
2540|006|Z|health care professional. Always ask your health care||
2540|007|Z|professional for complete information about this product and your||
2540|008|Z|specific health needs.||
2540|009|B|||
2540|010|T|TRIHEPTANOIN - ORAL||
2540|011|F|(trye-HEP-ta-noyn)||
2540|012|B|||
2540|013|C|COMMON BRAND NAME(S):  Dojolvi||
2540|014|B|||
2540|015|U|USES:  This medication is used to treat certain inherited||
2540|016|U|disorders (long-chain fatty acid oxidation disorders- LC-FAOD).||
2540|017|U|People with LC-FAOD cannot break down certain nutrients (fatty||
2540|018|U|acids) to use as energy due to the lack of certain enzymes.||
2540|019|U|Triheptanoin is not a cure for LC-FAOD but is a medium-chain||
2540|020|U|triglyceride that works by providing fatty acids and energy to||
2540|021|U|the body.||
2540|022|B|||
2540|023|H|HOW TO USE:  Read the Patient Information Leaflet and||
2540|024|H|Instructions for Use leaflet if available from your pharmacist||
2540|025|H|before you start taking this medication and each time you get a||
2540|026|H|refill. If you have any questions, ask your doctor or pharmacist.||
2540|027|H|   If you are taking any other medium-chain triglycerides, your||
2540|028|H|doctor will direct you to stop that medication before starting||
2540|029|H|triheptanoin. Consult your doctor or pharmacist for more details.||
2540|030|H|   Take this medication with food by mouth or through a feeding||
2540|031|H|tube as directed by your doctor, usually four times daily. This||
2540|032|H|medication should be taken at 3- or 4-hour intervals, with meals||
2540|033|H|or snacks.||
2540|034|H|   Carefully measure the dose using a special measuring||
2540|035|H|device/spoon. Do not use a household spoon because you may not||
2540|036|H|get the correct dose. Use only cups, containers, spoons, or oral||
2540|037|H|syringes that are safe to use with triheptanoin as described in||
2540|038|H|the Instructions for Use leaflet. Add the measured dose to a||
2540|039|H|container and mix with soft food or liquid (such as whole-grain||
2540|040|H|hot cereal, fat-free yogurt/milk/formula/cottage cheese, or||
2540|041|H|fat-free low-carbohydrate pudding/smoothies/applesauce/baby food)||
2540|042|H|as directed by your doctor. Take all of the mixture right away.||
2540|043|H|If not taken right away, the mixture may be stored in the||
2540|044|H|refrigerator for up to 24 hours.||
2540|045|H|   If you are giving this medication through a feeding tube, ask||
2540|046|H|your health care professional which feeding tubes are safe to use||
2540|047|H|with triheptanoin, and for detailed instructions on how to||
2540|048|H|properly mix and give it.||
2540|049|H|   To reduce your risk of side effects, your doctor may direct||
2540|050|H|you to start this medication at a low dose and gradually increase||
2540|051|H|your dose. Follow your doctor's instructions carefully.||
2540|052|H|   Use this medication regularly to get the most benefit from it.||
2540|053|H|To help you remember, take it at the same times each day. Do not||
2540|054|H|increase your dose or use this drug more often or for longer than||
2540|055|H|prescribed. Your condition will not improve any faster, and your||
2540|056|H|risk of side effects will increase.||
2540|057|H|   It is very important to continue to follow your doctor's||
2540|058|H|advice about diet while using this medication.||
2540|059|B|||
2540|060|S|SIDE EFFECTS:  Stomach/abdominal pain, diarrhea, nausea, or||
2540|061|S|vomiting may occur. If any of these effects last or get worse,||
2540|062|S|tell your doctor or pharmacist promptly.||
2540|063|S|   Remember that this medication has been prescribed because your||
2540|064|S|doctor has judged that the benefit to you is greater than the||
2540|065|S|risk of side effects. Many people using this medication do not||
2540|066|S|have serious side effects.||
2540|067|S|   A very serious allergic reaction to this drug is rare.||
2540|068|S|However, get medical help right away if you notice any symptoms||
2540|069|S|of a serious allergic reaction, including: rash, itching/swelling||
2540|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2540|071|S|breathing.||
2540|072|S|   This is not a complete list of possible side effects. If you||
2540|073|S|notice other effects not listed above, contact your doctor or||
2540|074|S|pharmacist.||
2540|075|S|   In the US -||
2540|076|S|   Call your doctor for medical advice about side effects. You||
2540|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2540|078|S|www.fda.gov/medwatch.||
2540|079|S|   In Canada - Call your doctor for medical advice about side||
2540|080|S|effects. You may report side effects to Health Canada at||
2540|081|S|1-866-234-2345.||
2540|082|B|||
2540|083|P|PRECAUTIONS:  Before taking triheptanoin, tell your doctor or||
2540|084|P|pharmacist if you are allergic to it; or if you have any other||
2540|085|P|allergies. This product may contain inactive ingredients, which||
2540|086|P|can cause allergic reactions or other problems. Talk to your||
2540|087|P|pharmacist for more details.||
2540|088|P|   Before using this medication, tell your doctor or pharmacist||
2540|089|P|your medical history, especially of: intestinal disease (such as||
2540|090|P|pancreatic insufficiency).||
2540|091|P|   Before having surgery, tell your doctor or dentist about all||
2540|092|P|the products you use (including prescription drugs,||
2540|093|P|nonprescription drugs, and herbal products).||
2540|094|P|   During pregnancy, this medication should be used only when||
2540|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
2540|096|P|   It is unknown if this medication passes into breast milk.||
2540|097|P|Consult your doctor before breastfeeding.||
2540|098|B|||
2540|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2540|100|I|medications work or increase your risk for serious side effects.||
2540|101|I|This document does not contain all possible drug interactions.||
2540|102|I|Keep a list of all the products you use (including||
2540|103|I|prescription/nonprescription drugs and herbal products) and share||
2540|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
2540|105|I|the dosage of any medicines without your doctor's approval.||
2540|106|I|   A product that may interact with this drug is: orlistat.||
2540|107|B|||
2540|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2540|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2540|110|O|poison control center right away. US residents can call||
2540|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2540|112|B|||
2540|113|N|NOTES:  Do not share this medication with others.||
2540|114|B|||
2540|115|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
2540|116|D|and take the following doses at 3- or 4-hour intervals. Skip the||
2540|117|D|missed dose if you cannot take all the prescribed doses in the||
2540|118|D|same day. Do not double the dose to catch up.||
2540|119|B|||
2540|120|R|STORAGE:  Store at room temperature. Do not freeze. Keep the||
2540|121|R|bottle upright. Do not store in containers made of polystyrene or||
2540|122|R|polyvinyl chloride (PVC). Ask your doctor or pharmacist for more||
2540|123|R|details. Once the bottle is opened, this medication expires after||
2540|124|R|9 months. Keep all medications away from children and pets.||
2540|125|R|   Do not flush medications down the toilet or pour them into a||
2540|126|R|drain unless instructed to do so. Properly discard this product||
2540|127|R|when it is expired or no longer needed. Consult your pharmacist||
2540|128|R|or local waste disposal company.||
2540|129|B|||
2540|130|A|Information last revised September 2024.||
2540|131|A|Copyright(c) 2025 First Databank, Inc.||
2540|132|B|||
2541|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2541|002|Z|does NOT have all possible information about this product. This||
2541|003|Z|information does not assure that this product is safe, effective,||
2541|004|Z|or appropriate for you. This information is not individual||
2541|005|Z|medical advice and does not substitute for the advice of your||
2541|006|Z|health care professional. Always ask your health care||
2541|007|Z|professional for complete information about this product and your||
2541|008|Z|specific health needs.||
2541|009|B|||
2541|010|T|SECUKINUMAB - INJECTION||
2541|011|F|(SEK-ue-KIN-ue-mab)||
2541|012|B|||
2541|013|C|COMMON BRAND NAME(S): Cosentyx||
2541|014|B|||
2541|015|U|USES:  This medication is used to treat certain types of||
2541|016|U|arthritis (such as arthritis of the spine, psoriatic arthritis,||
2541|017|U|axial spondyloarthritis). Secukinumab belongs to a class of drugs||
2541|018|U|known as monoclonal antibodies. It works by blocking a certain||
2541|019|U|natural protein in your body (interleukin-17A) that may cause||
2541|020|U|inflammation and swelling.||
2541|021|B|||
2541|022|H|HOW TO USE:  Read the Medication Guide provided by your||
2541|023|H|pharmacist before you start using secukinumab and each time you||
2541|024|H|get a treatment. If you have any questions, ask your doctor or||
2541|025|H|pharmacist.||
2541|026|H|   Before treatment with this medication, your doctor will make||
2541|027|H|sure that you have received all your vaccinations and also test||
2541|028|H|you for tuberculosis (TB). Your doctor should monitor you for||
2541|029|H|symptoms of TB during and after treatment with this drug. If||
2541|030|H|needed, treatment for tuberculosis or other infections should be||
2541|031|H|given before receiving this medication.||
2541|032|H|   This medication is given by slow injection into a vein by a||
2541|033|H|health care professional, usually over 30 minutes. It is given as||
2541|034|H|directed by your doctor, usually every 4 weeks. The dosage is||
2541|035|H|based on your medical condition, weight, and response to||
2541|036|H|treatment.||
2541|037|H|   Use this medication regularly to get the most benefit from it.||
2541|038|H|To help you remember, mark your calendar with a reminder.||
2541|039|H|   Tell your doctor if your condition does not get better or if||
2541|040|H|it gets worse.||
2541|041|B|||
2541|042|S|SIDE EFFECTS:  Diarrhea may occur. If this effect lasts or gets||
2541|043|S|worse, tell your doctor or pharmacist promptly.||
2541|044|S|   Remember that this medication has been prescribed because your||
2541|045|S|doctor has judged that the benefit to you is greater than the||
2541|046|S|risk of side effects. Many people using this medication do not||
2541|047|S|have serious side effects.||
2541|048|S|   This medication may lower your ability to fight infections.||
2541|049|S|This may make you more likely to get a serious infection or make||
2541|050|S|any infection you have worse. Tell your doctor right away if you||
2541|051|S|have any signs of infection (such as sore throat that doesn't go||
2541|052|S|away, fever, chills, white patches in the mouth).||
2541|053|S|   Tell your doctor right away if you have any serious side||
2541|054|S|effects, including: stomach/abdominal pain, diarrhea with||
2541|055|S|blood/mucus.||
2541|056|S|   A very serious allergic reaction to this drug is rare.||
2541|057|S|However, get medical help right away if you notice any symptoms||
2541|058|S|of a serious allergic reaction, including: rash, itching/swelling||
2541|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2541|060|S|breathing.||
2541|061|S|   This is not a complete list of possible side effects. If you||
2541|062|S|notice other effects not listed above, contact your doctor or||
2541|063|S|pharmacist.||
2541|064|S|   In the US -||
2541|065|S|   Call your doctor for medical advice about side effects. You||
2541|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2541|067|S|www.fda.gov/medwatch.||
2541|068|S|   In Canada - Call your doctor for medical advice about side||
2541|069|S|effects. You may report side effects to Health Canada at||
2541|070|S|1-866-234-2345.||
2541|071|B|||
2541|072|P|PRECAUTIONS:  Before using secukinumab, tell your doctor or||
2541|073|P|pharmacist if you are allergic to it; or if you have any other||
2541|074|P|allergies. This product may contain inactive ingredients, which||
2541|075|P|can cause allergic reactions or other problems. Talk to your||
2541|076|P|pharmacist for more details.||
2541|077|P|   Before using this medication, tell your doctor or pharmacist||
2541|078|P|your medical history, especially of: current/recent/returning||
2541|079|P|infection (such as tuberculosis, herpes, hepatitis), bowel||
2541|080|P|disease (such as Crohn's disease, ulcerative colitis).||
2541|081|P|   Secukinumab can make you more likely to get infections or may||
2541|082|P|make current infections worse. Stay away from anyone who has an||
2541|083|P|infection that may easily spread (such as chickenpox, COVID-19,||
2541|084|P|measles, flu). Talk to your doctor if you have been exposed to an||
2541|085|P|infection or for more details.||
2541|086|P|   Tell your health care professional that you are using||
2541|087|P|secukinumab before having any immunizations/vaccinations. Avoid||
2541|088|P|contact with people who have recently received live vaccines||
2541|089|P|(such as flu vaccine inhaled through the nose).||
2541|090|P|   Before having surgery, tell your doctor or dentist about all||
2541|091|P|the products you use (including prescription drugs,||
2541|092|P|nonprescription drugs, and herbal products).||
2541|093|P|   During pregnancy, this medication should be used only when||
2541|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
2541|095|P|   It is unknown if this medication passes into breast milk.||
2541|096|P|Consult your doctor before breastfeeding.||
2541|097|B|||
2541|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2541|099|I|medications work or increase your risk for serious side effects.||
2541|100|I|This document does not contain all possible drug interactions.||
2541|101|I|Keep a list of all the products you use (including||
2541|102|I|prescription/nonprescription drugs and herbal products) and share||
2541|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
2541|104|I|the dosage of any medicines without your doctor's approval.||
2541|105|B|||
2541|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2541|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2541|108|O|poison control center right away. US residents can call||
2541|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2541|110|B|||
2541|111|N|NOTES:  Lab and/or medical tests (such as complete blood count)||
2541|112|N|may be done while you are using this medication. Keep all medical||
2541|113|N|and lab appointments. Consult your doctor for more details.||
2541|114|B|||
2541|115|D|MISSED DOSE:  It is important to get each dose of this medication||
2541|116|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2541|117|D|right away for a new dosing schedule.||
2541|118|B|||
2541|119|R|STORAGE:  Not applicable. This medication is given in a hospital||
2541|120|R|or clinic and will not be stored at home.||
2541|121|B|||
2541|122|A|Information last revised April 2025.||
2541|123|A|Copyright(c) 2025 First Databank, Inc.||
2541|124|B|||
2542|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2542|002|Z|does NOT have all possible information about this product. This||
2542|003|Z|information does not assure that this product is safe, effective,||
2542|004|Z|or appropriate for you. This information is not individual||
2542|005|Z|medical advice and does not substitute for the advice of your||
2542|006|Z|health care professional. Always ask your health care||
2542|007|Z|professional for complete information about this product and your||
2542|008|Z|specific health needs.||
2542|009|B|||
2542|010|T|ETRASIMOD - ORAL||
2542|011|F|(e-TRAS-i-mod)||
2542|012|B|||
2542|013|C|COMMON BRAND NAME(S): Velsipity||
2542|014|B|||
2542|015|U|USES:  This medication is used to treat a certain bowel disease||
2542|016|U|(ulcerative colitis). Etrasimod helps to decrease symptoms of||
2542|017|U|ulcerative colitis such as diarrhea, rectal bleeding, and stomach||
2542|018|U|pain.||
2542|019|B|||
2542|020|H|HOW TO USE:  Read the Medication Guide provided by your||
2542|021|H|pharmacist before you start taking etrasimod and each time you||
2542|022|H|get a refill. If you have any questions, ask your doctor or||
2542|023|H|pharmacist.||
2542|024|H|   Take this medication by mouth with or without food as directed||
2542|025|H|by your doctor, usually once daily. Swallow the tablet whole.||
2542|026|H|   Use this medication regularly to get the most benefit from it.||
2542|027|H|To help you remember, take it at the same time each day.||
2542|028|H|   Do not increase your dose or use this drug more often or for||
2542|029|H|longer than prescribed. Your condition will not improve any||
2542|030|H|faster, and your risk of side effects will increase.||
2542|031|H|   Tell your doctor if your condition does not get better or if||
2542|032|H|it gets worse.||
2542|033|B|||
2542|034|S|SIDE EFFECTS:  Headache, dizziness, or lightheadedness may occur.||
2542|035|S|Slow heartbeat may also occur, especially after your first dose.||
2542|036|S|If any of these effects last or get worse, tell your doctor or||
2542|037|S|pharmacist promptly.||
2542|038|S|   To reduce the risk of dizziness and lightheadedness, get up||
2542|039|S|slowly when rising from a sitting or lying position.||
2542|040|S|   Remember that this medication has been prescribed because your||
2542|041|S|doctor has judged that the benefit to you is greater than the||
2542|042|S|risk of side effects. Many people using this medication do not||
2542|043|S|have serious side effects.||
2542|044|S|   This medication may raise your blood pressure. Check your||
2542|045|S|blood pressure regularly and tell your doctor if the results are||
2542|046|S|high.||
2542|047|S|   Tell your doctor right away if you have any serious side||
2542|048|S|effects, including: signs of liver disease (such as||
2542|049|S|nausea/vomiting that doesn't stop, loss of appetite,||
2542|050|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2542|051|S|shortness of breath, unusual tiredness.||
2542|052|S|   Etrasimod may rarely increase your risk of skin cancer. Tell||
2542|053|S|your doctor right away if you notice any unusual skin changes||
2542|054|S|(such as change in appearance/size of moles).||
2542|055|S|   This medication may lower your ability to fight infections||
2542|056|S|while you are taking it and for 5 weeks after your last dose.||
2542|057|S|This may make you more likely to get a serious (rarely fatal)||
2542|058|S|infection or make any infection you have worse. Tell your doctor||
2542|059|S|right away if you have any signs of infection (such as sore||
2542|060|S|throat that doesn't go away, fever, chills, sores, blisters,||
2542|061|S|painful/burning urination).||
2542|062|S|   This medication may increase your risk of getting a rare but||
2542|063|S|very serious (possibly fatal) brain infection (progressive||
2542|064|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2542|065|S|if you have any of these side effects: clumsiness, loss of||
2542|066|S|coordination/balance, weakness, sudden change in your thinking||
2542|067|S|(such as confusion, difficulty concentrating, memory loss),||
2542|068|S|difficulty talking/walking, seizure.||
2542|069|S|   Get medical help right away if you have any very serious side||
2542|070|S|effects, including: very slow heartbeat, fast/irregular||
2542|071|S|heartbeat, severe dizziness, fainting, eye pain/sensitivity to||
2542|072|S|light, vision changes (such as blurred vision, blind spot/shadows||
2542|073|S|in the center of your vision, color changes), sudden/severe||
2542|074|S|headache.||
2542|075|S|   A very serious allergic reaction to this drug is rare.||
2542|076|S|However, get medical help right away if you notice any symptoms||
2542|077|S|of a serious allergic reaction, including: rash, itching/swelling||
2542|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2542|079|S|breathing.||
2542|080|S|   This is not a complete list of possible side effects. If you||
2542|081|S|notice other effects not listed above, contact your doctor or||
2542|082|S|pharmacist.||
2542|083|S|   In the US -||
2542|084|S|   Call your doctor for medical advice about side effects. You||
2542|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2542|086|S|www.fda.gov/medwatch.||
2542|087|S|   In Canada - Call your doctor for medical advice about side||
2542|088|S|effects. You may report side effects to Health Canada at||
2542|089|S|1-866-234-2345.||
2542|090|B|||
2542|091|P|PRECAUTIONS:  Before taking etrasimod, tell your doctor or||
2542|092|P|pharmacist if you are allergic to it; or if you have any other||
2542|093|P|allergies. This product may contain inactive ingredients (such as||
2542|094|P|tartrazine), which can cause allergic reactions or other||
2542|095|P|problems. Talk to your pharmacist for more details.||
2542|096|P|   Before using this medication, tell your doctor or pharmacist||
2542|097|P|your medical history, especially of: breathing problems (such as||
2542|098|P|asthma, chronic obstructive pulmonary disease-COPD, sleep apnea),||
2542|099|P|current/recent/returning infection, diabetes, certain eye||
2542|100|P|problems (macular edema, uveitis), fainting, heart problems (such||
2542|101|P|as slow/irregular heartbeat, heart failure, previous heart||
2542|102|P|attack, chest pain, QT prolongation in the EKG), high blood||
2542|103|P|pressure, liver problems, skin cancer, stroke or||
2542|104|P|"mini-stroke"/transient ischemic attack (TIA).||
2542|105|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2542|106|P|can make you more dizzy. Do not drive, use machinery, or do||
2542|107|P|anything that needs alertness until you can do it safely. Limit||
2542|108|P|alcoholic beverages. Talk to your doctor if you are using||
2542|109|P|marijuana (cannabis).||
2542|110|P|   Etrasimod can make you more likely to get infections or may||
2542|111|P|make current infections worse while taking this medication and||
2542|112|P|for 5 weeks after the last dose. Stay away from anyone who has an||
2542|113|P|infection that may easily spread (such as chickenpox, COVID-19,||
2542|114|P|measles, flu). Talk to your doctor if you have been exposed to an||
2542|115|P|infection or for more details.||
2542|116|P|   Tell your doctor your vaccine history and ask if you need to||
2542|117|P|get any vaccines before starting treatment with this medication.||
2542|118|P|If a live vaccine is needed, it should be given at least 4 weeks||
2542|119|P|before starting this medication. Tell your health care||
2542|120|P|professional that you are using etrasimod before having any||
2542|121|P|immunizations/vaccinations. Avoid getting a live vaccine while||
2542|122|P|using this medication and for 5 weeks after the last dose. Avoid||
2542|123|P|contact with people who have recently received live vaccines||
2542|124|P|(such as flu vaccine inhaled through the nose).||
2542|125|P|   This medication may rarely increase your risk of skin cancer.||
2542|126|P|Limit your time in the sun. Avoid tanning booths and sunlamps.||
2542|127|P|Use sunscreen and wear protective clothing when outdoors. Your||
2542|128|P|doctor may direct you to avoid phototherapy while you use this||
2542|129|P|product. Ask your doctor for details.||
2542|130|P|   Before having surgery, tell your doctor or dentist about all||
2542|131|P|the products you use (including prescription drugs,||
2542|132|P|nonprescription drugs, and herbal products).||
2542|133|P|   Tell your doctor if you are pregnant or plan to become||
2542|134|P|pregnant. You should not become pregnant while using etrasimod.||
2542|135|P|Etrasimod may harm an unborn baby. Ask about reliable forms of||
2542|136|P|birth control while using this medication and for 7 days after||
2542|137|P|the last dose. If you become pregnant, talk to your doctor right||
2542|138|P|away about the risks and benefits of this medication.||
2542|139|P|   It is unknown if this medication passes into breast milk.||
2542|140|P|Consult your doctor before breastfeeding.||
2542|141|B|||
2542|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2542|143|I|medications work or increase your risk for serious side effects.||
2542|144|I|This document does not contain all possible drug interactions.||
2542|145|I|Keep a list of all the products you use (including||
2542|146|I|prescription/nonprescription drugs and herbal products) and share||
2542|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
2542|148|I|the dosage of any medicines without your doctor's approval.||
2542|149|I|   Some products that may interact with this drug are: other||
2542|150|I|drugs that weaken the immune system/increase the risk of||
2542|151|I|infection (such as natalizumab, rituximab).||
2542|152|I|   Other medications can affect the removal of etrasimod from||
2542|153|I|your body, which may affect how etrasimod works. Examples include||
2542|154|I|fluconazole, rifampin, among others.||
2542|155|B|||
2542|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2542|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2542|158|O|poison control center right away. US residents can call||
2542|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2542|160|B|||
2542|161|N|NOTES:  Do not share this medication with others.||
2542|162|N|   Lab and/or medical tests (such as complete blood count, blood||
2542|163|N|pressure, pulse, EKG, eye/skin exams, liver/lung function) should||
2542|164|N|be done before you start taking this medication and while you are||
2542|165|N|taking it. Keep all medical and lab appointments. Consult your||
2542|166|N|doctor for more details.||
2542|167|B|||
2542|168|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2542|169|D|next dose at the regular time. Do not double the dose to catch||
2542|170|D|up.||
2542|171|B|||
2542|172|R|STORAGE:  Store at room temperature away from light and moisture.||
2542|173|R|Do not store in the bathroom. Keep all medications away from||
2542|174|R|children and pets.||
2542|175|R|   Do not flush medications down the toilet or pour them into a||
2542|176|R|drain unless instructed to do so. Properly discard this product||
2542|177|R|when it is expired or no longer needed. Consult your pharmacist||
2542|178|R|or local waste disposal company.||
2542|179|B|||
2542|180|A|Information last revised April 2025.||
2542|181|A|Copyright(c) 2025 First Databank, Inc.||
2542|182|B|||
2543|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2543|002|Z|does NOT have all possible information about this product. This||
2543|003|Z|information does not assure that this product is safe, effective,||
2543|004|Z|or appropriate for you. This information is not individual||
2543|005|Z|medical advice and does not substitute for the advice of your||
2543|006|Z|health care professional. Always ask your health care||
2543|007|Z|professional for complete information about this product and your||
2543|008|Z|specific health needs.||
2543|009|B|||
2543|010|T|TENAPANOR - ORAL||
2543|011|F|(ten-A-pa-nor)||
2543|012|B|||
2543|013|C|COMMON BRAND NAME(S): Xphozah||
2543|014|B|||
2543|015|U|USES:  Tenapanor is used to lower high blood phosphate levels in||
2543|016|U|people who are on dialysis due to long-term kidney disease.||
2543|017|U|Dialysis removes some phosphate from your blood, but it is||
2543|018|U|difficult to remove enough to keep your phosphate levels||
2543|019|U|balanced. This medication works by decreasing how much phosphate||
2543|020|U|your body absorbs from the foods you eat. Decreasing blood||
2543|021|U|phosphate levels can help keep your bones strong, prevent unsafe||
2543|022|U|buildup of minerals in your body, and may decrease the risk of||
2543|023|U|heart disease and strokes that can result from high phosphate||
2543|024|U|levels.||
2543|025|U|   This medication must not be used by children younger than 6||
2543|026|U|years due to the risk for harm (especially serious dehydration).||
2543|027|B|||
2543|028|V|OTHER USES:  This section contains uses of this drug that are not||
2543|029|V|listed in the approved professional labeling for the drug but||
2543|030|V|that may be prescribed by your health care professional. Use this||
2543|031|V|drug for a condition that is listed in this section only if it||
2543|032|V|has been so prescribed by your health care professional.||
2543|033|V|   Tenapanor is also available in other brands and other||
2543|034|V|strengths to treat a certain bowel problem (irritable bowel||
2543|035|V|syndrome with constipation). Do not take this medication with any||
2543|036|V|other product that contains tenapanor.||
2543|037|B|||
2543|038|H|HOW TO USE:  Take this medication by mouth as directed by your||
2543|039|H|doctor, usually once right before the first meal of the day, and||
2543|040|H|once before the last meal of the day. On days when you have||
2543|041|H|dialysis, do not take a dose right before dialysis. If you need||
2543|042|H|to reschedule one of your daily doses around your dialysis||
2543|043|H|appointment, wait and take the skipped dose right before the next||
2543|044|H|meal you have after dialysis. The dosage is based on your medical||
2543|045|H|condition and response to treatment.||
2543|046|H|   Use this medication regularly to get the most benefit from it.||
2543|047|H|To help you remember, take it at the same times each day on days||
2543|048|H|when you don't have dialysis.||
2543|049|H|   Do not increase your dose or use this drug more often or for||
2543|050|H|longer than prescribed. Your condition will not improve any||
2543|051|H|faster, and your risk of side effects will increase.||
2543|052|H|   If you also take a certain drug (sodium polystyrene sulfonate)||
2543|053|H|to help lower the level of potassium in your blood, separate it||
2543|054|H|from tenapanor by at least 3 hours. Sodium polystyrene sulfonate||
2543|055|H|may decrease how well tenapanor works.||
2543|056|H|   Tell your doctor if your condition does not get better or if||
2543|057|H|it gets worse.||
2543|058|B|||
2543|059|S|SIDE EFFECTS:  Diarrhea may occur. If this effect lasts or gets||
2543|060|S|worse, tell your doctor or pharmacist promptly.||
2543|061|S|   Remember that this medication has been prescribed because your||
2543|062|S|doctor has judged that the benefit to you is greater than the||
2543|063|S|risk of side effects. Many people using this medication do not||
2543|064|S|have serious side effects.||
2543|065|S|   Tell your doctor right away if you have any serious side||
2543|066|S|effects, including: severe diarrhea.||
2543|067|S|   A very serious allergic reaction to this drug is rare.||
2543|068|S|However, get medical help right away if you notice any symptoms||
2543|069|S|of a serious allergic reaction, including: rash, itching/swelling||
2543|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2543|071|S|breathing.||
2543|072|S|   This is not a complete list of possible side effects. If you||
2543|073|S|notice other effects not listed above, contact your doctor or||
2543|074|S|pharmacist.||
2543|075|S|   In the US -||
2543|076|S|   Call your doctor for medical advice about side effects. You||
2543|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2543|078|S|www.fda.gov/medwatch.||
2543|079|S|   In Canada - Call your doctor for medical advice about side||
2543|080|S|effects. You may report side effects to Health Canada at||
2543|081|S|1-866-234-2345.||
2543|082|B|||
2543|083|P|PRECAUTIONS:  Before taking tenapanor, tell your doctor or||
2543|084|P|pharmacist if you are allergic to it; or if you have any other||
2543|085|P|allergies. This product may contain inactive ingredients, which||
2543|086|P|can cause allergic reactions or other problems. Talk to your||
2543|087|P|pharmacist for more details.||
2543|088|P|   Before using this medication, tell your doctor or pharmacist||
2543|089|P|your medical history, especially of: stomach/intestinal blockage.||
2543|090|P|   Before having surgery, tell your doctor or dentist about all||
2543|091|P|the products you use (including prescription drugs,||
2543|092|P|nonprescription drugs, and herbal products).||
2543|093|P|   During pregnancy, this medication should be used only when||
2543|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
2543|095|P|   This medication does not pass into breast milk. Consult your||
2543|096|P|doctor before breastfeeding.||
2543|097|B|||
2543|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2543|099|I|medications work or increase your risk for serious side effects.||
2543|100|I|This document does not contain all possible drug interactions.||
2543|101|I|Keep a list of all the products you use (including||
2543|102|I|prescription/nonprescription drugs and herbal products) and share||
2543|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
2543|104|I|the dosage of any medicines without your doctor's approval.||
2543|105|I|   Some products that may interact with this drug are: laxatives||
2543|106|I|(such as bisacodyl, docusate).||
2543|107|B|||
2543|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2543|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2543|110|O|poison control center right away. US residents can call||
2543|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2543|112|B|||
2543|113|N|NOTES:  Your doctor may direct you to follow a special diet to||
2543|114|N|help lower your blood phosphate levels. Follow the diet closely.||
2543|115|N|   Do not share this medication with others.||
2543|116|N|   Lab tests (such as blood phosphate levels) should be done||
2543|117|N|while you are taking this medication. Keep all medical and lab||
2543|118|N|appointments. Consult your doctor for more details.||
2543|119|B|||
2543|120|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2543|121|D|next dose just before the next meal. Do not double the dose to||
2543|122|D|catch up.||
2543|123|B|||
2543|124|R|STORAGE:  Store in the original container at room temperature||
2543|125|R|away from light and moisture. Do not store in the bathroom. Keep||
2543|126|R|the drying agent (desiccant) in the bottle. Tightly close the||
2543|127|R|bottle when not in use. Keep all medications away from children||
2543|128|R|and pets.||
2543|129|R|   Do not flush medications down the toilet or pour them into a||
2543|130|R|drain unless instructed to do so. Properly discard this product||
2543|131|R|when it is expired or no longer needed. Consult your pharmacist||
2543|132|R|or local waste disposal company.||
2543|133|B|||
2543|134|A|Information last revised May 2025.||
2543|135|A|Copyright(c) 2025 First Databank, Inc.||
2543|136|B|||
2544|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2544|002|Z|does NOT have all possible information about this product. This||
2544|003|Z|information does not assure that this product is safe, effective,||
2544|004|Z|or appropriate for you. This information is not individual||
2544|005|Z|medical advice and does not substitute for the advice of your||
2544|006|Z|health care professional. Always ask your health care||
2544|007|Z|professional for complete information about this product and your||
2544|008|Z|specific health needs.||
2544|009|B|||
2544|010|T|DEXTROAMPHETAMINE/AMPHETAMINE TRIPHASIC ER CAPSULE - ORAL||
2544|011|F|(DEX-troe-am-FET-a-meen/am-FET-a-meen)||
2544|012|B|||
2544|013|C|COMMON BRAND NAME(S): Mydayis||
2544|014|B|||
2544|015|W|WARNING:  Misuse or abuse of amphetamines may cause serious||
2544|016|W|(possibly fatal) heart and blood pressure problems.||
2544|017|W|Amphetamine-type medications can be habit-forming. Use only as||
2544|018|W|directed. If you use this drug for a long time, you may become||
2544|019|W|dependent on it and may have withdrawal symptoms after stopping||
2544|020|W|the drug. Consult your doctor or pharmacist for more details.||
2544|021|W|(See also How to Use section).||
2544|022|B|||
2544|023|U|USES:  This combination medication is used to treat attention||
2544|024|U|deficit hyperactivity disorder - ADHD. It works by changing the||
2544|025|U|amounts of certain natural substances in the brain.||
2544|026|U|Amphetamine/dextroamphetamine belongs to a class of drugs known||
2544|027|U|as stimulants. It can help increase your ability to pay||
2544|028|U|attention, stay focused on an activity, and control behavior||
2544|029|U|problems. It may also help you to organize your tasks and improve||
2544|030|U|listening skills.||
2544|031|B|||
2544|032|V|OTHER USES:  This section contains uses of this drug that are not||
2544|033|V|listed in the approved professional labeling for the drug but||
2544|034|V|that may be prescribed by your health care professional. Use this||
2544|035|V|drug for a condition that is listed in this section only if it||
2544|036|V|has been so prescribed by your health care professional.||
2544|037|V|   This drug may also be used for a certain sleeping disorder||
2544|038|V|(narcolepsy). It should not be used to treat tiredness or to hold||
2544|039|V|off sleep in people who do not have a sleep disorder.||
2544|040|B|||
2544|041|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2544|042|H|Patient Information Leaflet provided by your pharmacist before||
2544|043|H|you start taking amphetamine/dextroamphetamine and each time you||
2544|044|H|get a refill. If you have any questions, ask your doctor or||
2544|045|H|pharmacist.||
2544|046|H|   Take this medication by mouth with or without food as directed||
2544|047|H|by your doctor, usually once daily in the morning. You may take||
2544|048|H|this medication with or without food, but it is important to||
2544|049|H|choose one way and take this medication the same way with every||
2544|050|H|dose. Taking this medication after noon may cause trouble||
2544|051|H|sleeping (insomnia).||
2544|052|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
2544|053|H|Doing so can release all of the drug at once, increasing the risk||
2544|054|H|of side effects. If you have difficulty swallowing this||
2544|055|H|medication whole, you may sprinkle the entire contents of a||
2544|056|H|capsule on a small amount of applesauce just before taking.||
2544|057|H|Swallow the mixture right away. Do not chew the mixture, and do||
2544|058|H|not save it for future use. Drink a glass of liquid after each||
2544|059|H|dose.||
2544|060|H|   The dosage is based on your medical condition and response to||
2544|061|H|treatment. Your doctor may adjust your dose to find the dose that||
2544|062|H|is best for you. Follow your doctor's instructions carefully.||
2544|063|H|   Use this medication regularly to get the most benefit from it.||
2544|064|H|To help you remember, take it at the same time each day.||
2544|065|H|   During treatment, your doctor may occasionally recommend||
2544|066|H|stopping the medication for a short time to see whether there are||
2544|067|H|any changes in your behavior and whether the medication is still||
2544|068|H|needed.||
2544|069|H|   If you suddenly stop using this medication, you may have||
2544|070|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
2544|071|H|mental/mood changes such as depression). To help prevent||
2544|072|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
2544|073|H|more likely if you have used this medication for a long time or||
2544|074|H|in high doses. Tell your doctor or pharmacist right away if you||
2544|075|H|have withdrawal.||
2544|076|H|   When this medication is used for a long time, it may not work||
2544|077|H|as well. Talk with your doctor if this medication stops working||
2544|078|H|well.||
2544|079|H|   Though it helps many people, this medication may sometimes||
2544|080|H|cause addiction. This risk may be higher if you have a substance||
2544|081|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2544|082|H|Do not increase your dose, take it more often, or use it for a||
2544|083|H|longer time than prescribed. Properly stop the medication when so||
2544|084|H|directed.||
2544|085|H|   Tell your doctor if your condition does not get better or if||
2544|086|H|it gets worse.||
2544|087|B|||
2544|088|S|SIDE EFFECTS:  Loss of appetite, weight loss, dry mouth, stomach||
2544|089|S|upset/pain, nausea/vomiting, dizziness, headache, diarrhea,||
2544|090|S|fever, nervousness, and trouble sleeping may occur. If any of||
2544|091|S|these effects last or get worse, tell your doctor promptly.||
2544|092|S|   Remember that this medication has been prescribed because your||
2544|093|S|doctor has judged that the benefit to you is greater than the||
2544|094|S|risk of side effects. Many people using this medication do not||
2544|095|S|have serious side effects.||
2544|096|S|   This medication may raise your blood pressure. Check your||
2544|097|S|blood pressure regularly and tell your doctor if the results are||
2544|098|S|high.||
2544|099|S|   Tell your doctor right away if you have any serious side||
2544|100|S|effects, including: signs of blood flow problems in the fingers||
2544|101|S|or toes (such as coldness, numbness, pain, or skin color||
2544|102|S|changes), unusual wounds on the fingers or toes,||
2544|103|S|mental/mood/behavior changes (such as agitation, aggression, mood||
2544|104|S|swings, depression, abnormal thoughts, thoughts of suicide),||
2544|105|S|uncontrolled movements, continuous chewing movements/teeth||
2544|106|S|grinding, outbursts of words/sounds, change in sexual||
2544|107|S|ability/desire, frequent/prolonged erections (in males).||
2544|108|S|   Get medical help right away if you have any very serious side||
2544|109|S|effects, including: shortness of breath, chest/jaw/left arm pain,||
2544|110|S|fainting, severe headache, fast/pounding/irregular heartbeat,||
2544|111|S|seizures, weakness on one side of the body, trouble speaking,||
2544|112|S|confusion, swelling ankles/feet, extreme tiredness, blurred||
2544|113|S|vision.||
2544|114|S|   This medication may increase serotonin and rarely cause a very||
2544|115|S|serious condition called serotonin syndrome/toxicity. The risk||
2544|116|S|increases if you are also taking other drugs that increase||
2544|117|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2544|118|S|take (see Drug Interactions section). Get medical help right away||
2544|119|S|if you develop some of the following symptoms: fast heartbeat,||
2544|120|S|hallucinations, loss of coordination, severe dizziness, severe||
2544|121|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2544|122|S|unusual agitation/restlessness.||
2544|123|S|   A very serious allergic reaction to this drug is rare.||
2544|124|S|However, get medical help right away if you notice any symptoms||
2544|125|S|of a serious allergic reaction, including: rash, itching/swelling||
2544|126|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2544|127|S|breathing.||
2544|128|S|   This is not a complete list of possible side effects. If you||
2544|129|S|notice other effects not listed above, contact your doctor or||
2544|130|S|pharmacist.||
2544|131|S|   In the US -||
2544|132|S|   Call your doctor for medical advice about side effects. You||
2544|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2544|134|S|www.fda.gov/medwatch.||
2544|135|S|   In Canada - Call your doctor for medical advice about side||
2544|136|S|effects. You may report side effects to Health Canada at||
2544|137|S|1-866-234-2345.||
2544|138|B|||
2544|139|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2544|140|P|pharmacist if you are allergic to it; or to other sympathomimetic||
2544|141|P|drugs (such as lisdexamfetamine); or if you have any other||
2544|142|P|allergies. This product may contain inactive ingredients, which||
2544|143|P|can cause allergic reactions or other problems. Talk to your||
2544|144|P|pharmacist for more details.||
2544|145|P|   Before using this medication, tell your doctor or pharmacist||
2544|146|P|your medical history, especially of: blood circulation problems||
2544|147|P|(such as Raynaud's disease), certain mental/mood conditions (such||
2544|148|P|as agitation, psychosis), personal/family history of mental/mood||
2544|149|P|disorders (such as bipolar disorder, depression, psychotic||
2544|150|P|disorder, suicidal thoughts), heart problems (including irregular||
2544|151|P|heartbeat/rhythm, coronary artery disease, heart failure,||
2544|152|P|cardiomyopathy, problems with the heart structure such as valve||
2544|153|P|problems), family history of heart problems (such as sudden||
2544|154|P|death/irregular heartbeat/rhythm), history of stroke, high blood||
2544|155|P|pressure, overactive thyroid (hyperthyroidism), a certain eye||
2544|156|P|problem (glaucoma), seizures, personal or family history of a||
2544|157|P|substance use disorder (such as overuse of or addiction to||
2544|158|P|drugs/alcohol), personal or family history of uncontrolled muscle||
2544|159|P|movements (such as Tourette's syndrome), kidney disease, liver||
2544|160|P|disease.||
2544|161|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2544|162|P|can make you more dizzy. Do not drive, use machinery, or do||
2544|163|P|anything that needs alertness until you can do it safely. Limit||
2544|164|P|alcoholic beverages. Talk to your doctor if you are using||
2544|165|P|marijuana (cannabis).||
2544|166|P|   Before having surgery, tell your doctor or dentist about all||
2544|167|P|the products you use (including prescription drugs,||
2544|168|P|nonprescription drugs, and herbal products).||
2544|169|P|   Children (especially those younger than 6) may be more||
2544|170|P|sensitive to the side effects of this drug, especially weight||
2544|171|P|loss. This medication may slow down a child's growth. The doctor||
2544|172|P|may recommend temporarily stopping the medication from time to||
2544|173|P|time to reduce this risk. Monitor your child's weight and height.||
2544|174|P|Consult your doctor or pharmacist for more details.||
2544|175|P|   Older adults may be more sensitive to the side effects of this||
2544|176|P|drug, especially chest pain, trouble sleeping, or weight loss.||
2544|177|P|   During pregnancy, this medication should be used only when||
2544|178|P|clearly needed. Discuss the risks and benefits with your doctor.||
2544|179|P|Infants born to mothers who are dependent on this medication may||
2544|180|P|be born too soon (premature) and have low birth weight. They may||
2544|181|P|also have withdrawal symptoms. Tell your doctor right away if you||
2544|182|P|notice possible mood changes, agitation, or unusual tiredness in||
2544|183|P|your newborn.||
2544|184|P|   This medication passes into breast milk and may have||
2544|185|P|undesirable effects on a nursing infant. Breastfeeding is not||
2544|186|P|recommended while using this medication. Consult your doctor||
2544|187|P|before breastfeeding.||
2544|188|B|||
2544|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2544|190|I|medications work or increase your risk for serious side effects.||
2544|191|I|This document does not contain all possible drug interactions.||
2544|192|I|Keep a list of all the products you use (including||
2544|193|I|prescription/nonprescription drugs and herbal products) and share||
2544|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
2544|195|I|the dosage of any medicines without your doctor's approval.||
2544|196|I|   Taking MAO inhibitors with this medication may cause a serious||
2544|197|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2544|198|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2544|199|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2544|200|I|selegiline, tranylcypromine) during treatment with this||
2544|201|I|medication. Most MAO inhibitors should also not be taken for two||
2544|202|I|weeks before treatment with this medication. Ask your doctor when||
2544|203|I|to start or stop taking this medication.||
2544|204|I|   Some products have ingredients that could raise your heart||
2544|205|I|rate or blood pressure. Tell your pharmacist what products you||
2544|206|I|are using, and ask how to use them safely (especially||
2544|207|I|cough-and-cold products or diet aids).||
2544|208|I|   The risk of serotonin syndrome/toxicity increases if you are||
2544|209|I|also taking other drugs that increase serotonin. Examples include||
2544|210|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
2544|211|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2544|212|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2544|213|I|serotonin syndrome/toxicity may be more likely when you start or||
2544|214|I|increase the dose of these drugs.||
2544|215|I|   Dextroamphetamine is very similar to lisdexamfetamine. Do not||
2544|216|I|use medications containing lisdexamfetamine while using||
2544|217|I|dextroamphetamine.||
2544|218|I|   This medication may interfere with certain medical/lab tests||
2544|219|I|(such as blood and urine steroid levels, brain scan for||
2544|220|I|Parkinson's disease), possibly causing false test results. Make||
2544|221|I|sure lab personnel and all your doctors know you use this drug.||
2544|222|B|||
2544|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2544|224|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2544|225|O|poison control center right away. US residents can call||
2544|226|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2544|227|O|Symptoms of overdose may include: headache that is severe or||
2544|228|O|doesn't go away, severe mental/mood changes, seizures, severe||
2544|229|O|restlessness, fast breathing.||
2544|230|B|||
2544|231|N|NOTES:  Do not change brands or dosage forms of this medication||
2544|232|N|without consulting your doctor or pharmacist. Not all forms of||
2544|233|N|this medication work the same way.||
2544|234|N|   Do not share this medication with others. Sharing it is||
2544|235|N|against the law.||
2544|236|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
2544|237|N|growth monitoring in children) may be done while you are taking||
2544|238|N|this medication. Keep all medical and lab appointments. Consult||
2544|239|N|your doctor for more details.||
2544|240|B|||
2544|241|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
2544|242|D|in the morning hours. If it is after noon or near the time of the||
2544|243|D|next dose, skip the missed dose. Take your next dose at the||
2544|244|D|regular time. Do not double the dose to catch up.||
2544|245|B|||
2544|246|R|STORAGE:  Store at room temperature away from light and moisture.||
2544|247|R|Do not store in the bathroom. Keep all medications away from||
2544|248|R|children and pets.||
2544|249|R|   Do not flush medications down the toilet or pour them into a||
2544|250|R|drain unless instructed to do so. Properly discard this product||
2544|251|R|when it is expired or no longer needed. Consult your pharmacist||
2544|252|R|or local waste disposal company.||
2544|253|B|||
2544|254|A|Information last revised July 2025.||
2544|255|A|Copyright(c) 2025 First Databank, Inc.||
2544|256|B|||
2545|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2545|002|Z|does NOT have all possible information about this product. This||
2545|003|Z|information does not assure that this product is safe, effective,||
2545|004|Z|or appropriate for you. This information is not individual||
2545|005|Z|medical advice and does not substitute for the advice of your||
2545|006|Z|health care professional. Always ask your health care||
2545|007|Z|professional for complete information about this product and your||
2545|008|Z|specific health needs.||
2545|009|B|||
2545|010|T|MIRIKIZUMAB - INJECTION||
2545|011|F|(MIR-i-KIZ-ue-mab)||
2545|012|B|||
2545|013|C|COMMON BRAND NAME(S): Omvoh||
2545|014|B|||
2545|015|U|USES:  This medication is used to treat certain bowel diseases||
2545|016|U|(ulcerative colitis, Crohn's disease). Mirikizumab belongs to a||
2545|017|U|class of drugs known as monoclonal antibodies. It works by||
2545|018|U|blocking a certain natural protein in your body (interleukin-23)||
2545|019|U|that may cause inflammation and swelling.||
2545|020|B|||
2545|021|H|HOW TO USE:  Read the Medication Guide and the Instructions for||
2545|022|H|Use leaflet provided by your pharmacist before you start using||
2545|023|H|mirikizumab and each time you get a refill. Ask your health care||
2545|024|H|professional how to prepare and use this medication. If you have||
2545|025|H|any questions, ask your doctor or pharmacist.||
2545|026|H|   Before treatment with this medication, your doctor will test||
2545|027|H|you for tuberculosis (TB). Your doctor should also monitor you||
2545|028|H|for symptoms of TB during and after treatment with this drug. If||
2545|029|H|needed, treatment for TB or other infections should be given||
2545|030|H|before using this medication.||
2545|031|H|   This medication is given by injection as directed by your||
2545|032|H|doctor, usually every 4 weeks. For the first 3 or 6 doses, the||
2545|033|H|medication is given by injection into a vein by a health care||
2545|034|H|professional. Later doses are given by injection under the skin.||
2545|035|H|Each dose given under the skin requires 2 injections, one after||
2545|036|H|the other. The injection is given in the thighs, the abdomen (at||
2545|037|H|least 2 inches from your belly button), or the back of the upper||
2545|038|H|arms. The dosage and treatment schedule are based on your medical||
2545|039|H|condition and response to treatment.||
2545|040|H|   Depending on your product, take the medication out of the||
2545|041|H|refrigerator at least 30-45 minutes before you inject it to allow||
2545|042|H|it to reach room temperature. Do not warm up this medication any||
2545|043|H|other way (for example, do not heat it in the microwave or place||
2545|044|H|it in hot water). Do not shake the medication. Before using,||
2545|045|H|check this product for cloudiness, particles, or discoloration.||
2545|046|H|If you see any of these things, do not use the liquid. Before||
2545|047|H|injecting each prefilled pen or syringe, clean the skin you are||
2545|048|H|going to inject into (the injection site) with rubbing alcohol.||
2545|049|H|Change the injection site each time to lessen injury under the||
2545|050|H|skin. Do not inject into skin that is tender, sore, bruised, red,||
2545|051|H|or hardened. To lessen bruising, do not rub the injection site||
2545|052|H|after a shot. Learn how to store and discard medical supplies||
2545|053|H|safely.||
2545|054|H|   Use this medication regularly to get the most benefit from it.||
2545|055|H|To help you remember, mark your calendar with a reminder.||
2545|056|H|   Tell your doctor if your condition lasts or gets worse.||
2545|057|B|||
2545|058|S|SIDE EFFECTS:  Redness, pain, or swelling may occur at the||
2545|059|S|injection site. Headache or joint pain may also occur. If any of||
2545|060|S|these effects last or get worse, tell your doctor or pharmacist||
2545|061|S|promptly.||
2545|062|S|   Remember that this medication has been prescribed because your||
2545|063|S|doctor has judged that the benefit to you is greater than the||
2545|064|S|risk of side effects. Many people using this medication do not||
2545|065|S|have serious side effects.||
2545|066|S|   This medication may lower your ability to fight infections.||
2545|067|S|This may make you more likely to get a serious (rarely fatal)||
2545|068|S|infection or make any infection you have worse. Tell your doctor||
2545|069|S|right away if you have any signs of infection (such as sore||
2545|070|S|throat that doesn't go away, fever, chills).||
2545|071|S|   Get medical help right away if you have any very serious side||
2545|072|S|effects, including: signs of liver problems (such as||
2545|073|S|nausea/vomiting that doesn't stop, loss of appetite, yellowing||
2545|074|S|eyes/skin, dark urine).||
2545|075|S|   A very serious allergic reaction to this drug is rare.||
2545|076|S|However, get medical help right away if you notice any symptoms||
2545|077|S|of a serious allergic reaction, including: rash, itching/swelling||
2545|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2545|079|S|breathing.||
2545|080|S|   This is not a complete list of possible side effects. If you||
2545|081|S|notice other effects not listed above, contact your doctor or||
2545|082|S|pharmacist.||
2545|083|S|   In the US -||
2545|084|S|   Call your doctor for medical advice about side effects. You||
2545|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2545|086|S|www.fda.gov/medwatch.||
2545|087|S|   In Canada - Call your doctor for medical advice about side||
2545|088|S|effects. You may report side effects to Health Canada at||
2545|089|S|1-866-234-2345.||
2545|090|B|||
2545|091|P|PRECAUTIONS:  Before using mirikizumab, tell your doctor or||
2545|092|P|pharmacist if you are allergic to it; or if you have any other||
2545|093|P|allergies. This product may contain inactive ingredients, which||
2545|094|P|can cause allergic reactions or other problems. Talk to your||
2545|095|P|pharmacist for more details.||
2545|096|P|   Before using this medication, tell your doctor or pharmacist||
2545|097|P|your medical history, especially of: current/recent/returning||
2545|098|P|infection (such as tuberculosis, herpes).||
2545|099|P|   Mirikizumab can make you more likely to get infections or may||
2545|100|P|make current infections worse. Stay away from anyone who has an||
2545|101|P|infection that may easily spread (such as chickenpox, COVID-19,||
2545|102|P|measles, flu). Talk to your doctor if you have been exposed to an||
2545|103|P|infection or for more details.||
2545|104|P|   Tell your health care professional that you are using||
2545|105|P|mirikizumab before having any immunizations/vaccinations. Avoid||
2545|106|P|contact with people who have recently received live vaccines||
2545|107|P|(such as flu vaccine inhaled through the nose).||
2545|108|P|   Before having surgery, tell your doctor or dentist about all||
2545|109|P|the products you use (including prescription drugs,||
2545|110|P|nonprescription drugs, and herbal products).||
2545|111|P|   During pregnancy, this medication should be used only when||
2545|112|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2545|113|P|benefits with your doctor.||
2545|114|P|   It is unknown if this medication passes into breast milk.||
2545|115|P|Consult your doctor before breastfeeding.||
2545|116|B|||
2545|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2545|118|I|medications work or increase your risk for serious side effects.||
2545|119|I|This document does not contain all possible drug interactions.||
2545|120|I|Keep a list of all the products you use (including||
2545|121|I|prescription/nonprescription drugs and herbal products) and share||
2545|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
2545|123|I|the dosage of any medicines without your doctor's approval.||
2545|124|B|||
2545|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2545|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2545|127|O|poison control center right away. US residents can call||
2545|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2545|129|B|||
2545|130|N|NOTES:  Do not share this medication with others.||
2545|131|N|   Lab and/or medical tests (such as liver function) should be||
2545|132|N|done before you start using this medication and while you are||
2545|133|N|using it. Keep all medical and lab appointments. Consult your||
2545|134|N|doctor for more details.||
2545|135|B|||
2545|136|D|MISSED DOSE:  It is important to get each dose of this medication||
2545|137|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2545|138|D|right away for a new dosing schedule. Do not double the dose to||
2545|139|D|catch up.||
2545|140|B|||
2545|141|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2545|142|R|medication in the original carton to protect from light. The||
2545|143|R|prefilled pen or syringe may also be stored at room temperature||
2545|144|R|if needed. If the prefilled pen or syringe is stored at room||
2545|145|R|temperature, do not put it back in the refrigerator and discard||
2545|146|R|after 2 weeks. Keep all medications away from children and pets.||
2545|147|R|   Do not flush medications down the toilet or pour them into a||
2545|148|R|drain unless instructed to do so. Properly discard this product||
2545|149|R|when it is expired or no longer needed. Consult your pharmacist||
2545|150|R|or local waste disposal company.||
2545|151|B|||
2545|152|A|Information last revised April 2025.||
2545|153|A|Copyright(c) 2025 First Databank, Inc.||
2545|154|B|||
2546|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2546|002|Z|does NOT have all possible information about this product. This||
2546|003|Z|information does not assure that this product is safe, effective,||
2546|004|Z|or appropriate for you. This information is not individual||
2546|005|Z|medical advice and does not substitute for the advice of your||
2546|006|Z|health care professional. Always ask your health care||
2546|007|Z|professional for complete information about this product and your||
2546|008|Z|specific health needs.||
2546|009|B|||
2546|010|T|VONOPRAZAN - ORAL||
2546|011|F|(von-OH-pra-zan)||
2546|012|B|||
2546|013|C|COMMON BRAND NAME(S): Voquezna||
2546|014|B|||
2546|015|U|USES:  Vonoprazan is used to treat certain throat (esophagus)||
2546|016|U|problems (erosive esophagitis, heartburn). It is also used with||
2546|017|U|other medications to treat an infection caused by the bacteria H.||
2546|018|U|pylori. This bacteria can cause stomach/intestinal ulcers and||
2546|019|U|irritation/swelling of the lining of the stomach. Vonoprazan is||
2546|020|U|an acid blocker. It works by decreasing the amount of acid your||
2546|021|U|stomach makes. Decreasing excess stomach acid can help ulcers||
2546|022|U|heal and relieve symptoms such as heartburn and stomach pain.||
2546|023|B|||
2546|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2546|025|H|from your pharmacist before you start taking vonoprazan and each||
2546|026|H|time you get a refill. If you have any questions, ask your doctor||
2546|027|H|or pharmacist.||
2546|028|H|   Take this medication by mouth with or without food as directed||
2546|029|H|by your doctor, usually once or twice daily. The dosage and||
2546|030|H|length of treatment are based on your medical condition.||
2546|031|H|   The tablet may have a bitter taste if you chew or crush it||
2546|032|H|before taking it. The manufacturer recommends swallowing the||
2546|033|H|whole tablet without crushing or chewing.||
2546|034|H|   Use this medication regularly to get the most benefit from it.||
2546|035|H|To help you remember, take it at the same time(s) each day.||
2546|036|H|Continue to take this medication until the full prescribed amount||
2546|037|H|is finished, even if symptoms disappear after a few days.||
2546|038|H|   Do not increase your dose or use this drug more often or for||
2546|039|H|longer than prescribed. Your condition will not improve any||
2546|040|H|faster, and your risk of side effects will increase.||
2546|041|H|   Tell your doctor if your condition lasts or gets worse.||
2546|042|B|||
2546|043|S|SIDE EFFECTS:  Diarrhea or nausea may occur. If either of these||
2546|044|S|effects lasts or gets worse, tell your doctor or pharmacist||
2546|045|S|promptly.||
2546|046|S|   Remember that this medication has been prescribed because your||
2546|047|S|doctor has judged that the benefit to you is greater than the||
2546|048|S|risk of side effects. Many people using this medication do not||
2546|049|S|have serious side effects.||
2546|050|S|   Tell your doctor right away if you have any serious side||
2546|051|S|effects, including: signs of kidney problems (such as change in||
2546|052|S|the amount of urine, bloody urine), symptoms of a low magnesium||
2546|053|S|blood level (such as muscle spasms, irregular heartbeat,||
2546|054|S|seizures).||
2546|055|S|   This medication may rarely cause a severe intestinal condition||
2546|056|S|due to a bacteria called C. difficile. This condition may occur||
2546|057|S|during treatment or weeks to months after treatment has stopped.||
2546|058|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2546|059|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2546|060|S|stool.||
2546|061|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2546|062|S|products because they may make symptoms worse.||
2546|063|S|   Rarely, acid-reducing drugs (such as vonoprazan) have caused||
2546|064|S|vitamin B-12 deficiency. The risk is increased if the drugs are||
2546|065|S|taken for a long time. Tell your doctor right away if you develop||
2546|066|S|symptoms of vitamin B-12 deficiency (such as unusual weakness,||
2546|067|S|sore tongue, or numbness/tingling of the hands/feet).||
2546|068|S|   A very serious allergic reaction to this drug is rare.||
2546|069|S|However, get medical help right away if you notice any symptoms||
2546|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2546|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2546|072|S|breathing.||
2546|073|S|   This is not a complete list of possible side effects. If you||
2546|074|S|notice other effects not listed above, contact your doctor or||
2546|075|S|pharmacist.||
2546|076|S|   In the US -||
2546|077|S|   Call your doctor for medical advice about side effects. You||
2546|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2546|079|S|www.fda.gov/medwatch.||
2546|080|S|   In Canada - Call your doctor for medical advice about side||
2546|081|S|effects. You may report side effects to Health Canada at||
2546|082|S|1-866-234-2345.||
2546|083|B|||
2546|084|P|PRECAUTIONS:  Before taking vonoprazan, tell your doctor or||
2546|085|P|pharmacist if you are allergic to it; or if you have any other||
2546|086|P|allergies. This product may contain inactive ingredients, which||
2546|087|P|can cause allergic reactions or other problems. Talk to your||
2546|088|P|pharmacist for more details.||
2546|089|P|   Before using this medication, tell your doctor or pharmacist||
2546|090|P|your medical history, especially of: liver disease, kidney||
2546|091|P|disease.||
2546|092|P|   Some symptoms may actually be signs of a more serious||
2546|093|P|condition. Get medical help right away if you have: heartburn||
2546|094|P|with lightheadedness/sweating/dizziness, chest/jaw/left arm pain||
2546|095|P|(especially with shortness of breath, unusual sweating),||
2546|096|P|unexplained weight loss.||
2546|097|P|   Before having surgery, tell your doctor or dentist about all||
2546|098|P|the products you use (including prescription drugs,||
2546|099|P|nonprescription drugs, and herbal products).||
2546|100|P|   Related drugs (proton pump inhibitors) may increase the risk||
2546|101|P|for bone fractures, especially with longer use, higher doses, and||
2546|102|P|in older adults. This risk may also apply to this drug. Talk with||
2546|103|P|your doctor or pharmacist about ways to prevent bone||
2546|104|P|loss/fracture, such as by taking calcium (such as calcium||
2546|105|P|citrate) and vitamin D supplements.||
2546|106|P|   Older adults may be more sensitive to the side effects of this||
2546|107|P|drug, especially C. difficile infection (see Side Effects||
2546|108|P|section).||
2546|109|P|   During pregnancy, this medication should be used only when||
2546|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
2546|111|P|   This medication passes into breast milk. Consult your doctor||
2546|112|P|before breastfeeding.||
2546|113|B|||
2546|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2546|115|I|medications work or increase your risk for serious side effects.||
2546|116|I|This document does not contain all possible drug interactions.||
2546|117|I|Keep a list of all the products you use (including||
2546|118|I|prescription/nonprescription drugs and herbal products) and share||
2546|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
2546|120|I|the dosage of any medicines without your doctor's approval.||
2546|121|I|   Other medications can affect the removal of vonoprazan from||
2546|122|I|your body, which may affect how vonoprazan works. Examples||
2546|123|I|include rifamycins (such as rifabutin), among others.||
2546|124|I|   Some products need stomach acid so that the body can absorb||
2546|125|I|them properly. Vonoprazan decreases stomach acid, so it may||
2546|126|I|change how well these products work. Some affected products||
2546|127|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
2546|128|I|pazopanib, rilpivirine, certain azole antifungals (itraconazole,||
2546|129|I|ketoconazole, posaconazole), among others.||
2546|130|I|   This medication may interfere with certain lab tests, possibly||
2546|131|I|causing false test results. Make sure lab personnel and all your||
2546|132|I|doctors know you use this drug.||
2546|133|B|||
2546|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2546|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2546|136|O|poison control center right away. US residents can call||
2546|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2546|138|B|||
2546|139|N|NOTES:  Do not share this medication with others.||
2546|140|N|   Lab and/or medical tests (such as magnesium level, vitamin||
2546|141|N|B-12 level) may be done while you are taking this medication.||
2546|142|N|Keep all medical and lab appointments. Consult your doctor for||
2546|143|N|more details.||
2546|144|B|||
2546|145|D|MISSED DOSE:  If you are using this drug to treat erosive||
2546|146|D|esophagitis or heartburn and miss a dose, take it as soon as you||
2546|147|D|remember. If it is more than 12 hours after the missed dose, skip||
2546|148|D|the missed dose. Take your next dose at the regular time. Do not||
2546|149|D|double the dose to catch up.||
2546|150|D|   If you are using this drug to treat H. pylori and miss a dose,||
2546|151|D|take it as soon as you remember. If it is more than 4 hours after||
2546|152|D|the missed dose, skip the missed dose. Take your next dose at the||
2546|153|D|regular time. Do not double the dose to catch up.||
2546|154|B|||
2546|155|R|STORAGE:  Store at room temperature away from light and moisture.||
2546|156|R|Do not store in the bathroom. Keep all medications away from||
2546|157|R|children and pets.||
2546|158|R|   Do not flush medications down the toilet or pour them into a||
2546|159|R|drain unless instructed to do so. Properly discard this product||
2546|160|R|when it is expired or no longer needed. Consult your pharmacist||
2546|161|R|or local waste disposal company.||
2546|162|B|||
2546|163|A|Information last revised November 2025.||
2546|164|A|Copyright(c) 2025 First Databank, Inc.||
2546|165|B|||
2547|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2547|002|Z|does NOT have all possible information about this product. This||
2547|003|Z|information does not assure that this product is safe, effective,||
2547|004|Z|or appropriate for you. This information is not individual||
2547|005|Z|medical advice and does not substitute for the advice of your||
2547|006|Z|health care professional. Always ask your health care||
2547|007|Z|professional for complete information about this product and your||
2547|008|Z|specific health needs.||
2547|009|B|||
2547|010|T|ZURANOLONE - ORAL||
2547|011|F|(zoo-RAN-oh-lone)||
2547|012|B|||
2547|013|C|COMMON BRAND NAME(S): Zurzuvae||
2547|014|B|||
2547|015|W|WARNING:  This drug may make you dizzy, drowsy, or slow down||
2547|016|W|thinking. This may cause you to be at a higher risk for falls||
2547|017|W|while taking this medication. You may not be able to tell on your||
2547|018|W|own how much zuranolone is affecting you or if you can drive or||
2547|019|W|do other activities safely. Do not drive, use machinery, or do||
2547|020|W|anything that needs alertness for at least 12 hours after taking||
2547|021|W|this medication. Avoid alcoholic beverages. Talk to your doctor||
2547|022|W|if you are using marijuana (cannabis).||
2547|023|B|||
2547|024|U|USES:  This medication is used to treat a certain type of||
2547|025|U|depression (postpartum depression). Zuranolone is thought to work||
2547|026|U|by affecting the balance of certain natural substances in the||
2547|027|U|brain.||
2547|028|B|||
2547|029|H|HOW TO USE:  Read the Medication Guide provided by your||
2547|030|H|pharmacist before you start taking zuranolone. If you have any||
2547|031|H|questions, ask your doctor or pharmacist.||
2547|032|H|   Take this medication by mouth with fat-containing food as||
2547|033|H|directed by your doctor, usually once daily in the evening for 14||
2547|034|H|days. The dosage is based on your medical condition, response to||
2547|035|H|treatment, and other medications you may be taking. Be sure to||
2547|036|H|tell your doctor and pharmacist about all the products you use||
2547|037|H|(including prescription drugs, nonprescription drugs, and herbal||
2547|038|H|products).||
2547|039|H|   Do not increase your dose or use this drug more often or for||
2547|040|H|longer than prescribed. Your condition will not improve any||
2547|041|H|faster, and your risk of side effects will increase.||
2547|042|H|   Though it helps many people, this medication may sometimes||
2547|043|H|cause addiction. This risk may be higher if you have a substance||
2547|044|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2547|045|H|Take this medication exactly as prescribed to lower the risk of||
2547|046|H|addiction. Ask your doctor or pharmacist for more details.||
2547|047|H|   Tell your doctor if you do not get better or if you get worse.||
2547|048|B|||
2547|049|S|SIDE EFFECTS:  See also Warning section.||
2547|050|S|   Drowsiness, dizziness, diarrhea, or tiredness may occur. If||
2547|051|S|any of these effects lasts or gets worse, tell your doctor or||
2547|052|S|pharmacist promptly.||
2547|053|S|   Remember that this medication has been prescribed because your||
2547|054|S|doctor has judged that the benefit to you is greater than the||
2547|055|S|risk of side effects. Many people using this medication do not||
2547|056|S|have serious side effects.||
2547|057|S|   Tell your doctor right away if you have any serious side||
2547|058|S|effects, including: confusion, trouble walking.||
2547|059|S|   Antidepressant medications are used to treat a variety of||
2547|060|S|conditions, including depression and other mental/mood disorders.||
2547|061|S|These medications can help prevent suicidal thoughts/attempts and||
2547|062|S|provide other important benefits. However, studies have shown||
2547|063|S|that a small number of people (especially people younger than 25)||
2547|064|S|who take antidepressants for any condition may experience||
2547|065|S|worsening depression, other mental/mood symptoms, or suicidal||
2547|066|S|thoughts/attempts. It is very important to talk with the doctor||
2547|067|S|about the risks and benefits of antidepressant medication||
2547|068|S|(especially for people younger than 25), even if treatment is not||
2547|069|S|for a mental/mood condition.||
2547|070|S|   Tell the doctor right away if you notice worsening||
2547|071|S|depression/other psychiatric conditions, unusual behavior changes||
2547|072|S|(including possible suicidal thoughts/attempts), or other||
2547|073|S|mental/mood changes (including new/worsening anxiety, panic||
2547|074|S|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2547|075|S|impulsive actions, severe restlessness, very rapid speech). Be||
2547|076|S|especially watchful for these symptoms when a new antidepressant||
2547|077|S|is started or when the dose is changed.||
2547|078|S|   A very serious allergic reaction to this drug is rare.||
2547|079|S|However, get medical help right away if you notice any symptoms||
2547|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2547|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2547|082|S|breathing.||
2547|083|S|   This is not a complete list of possible side effects. If you||
2547|084|S|notice other effects not listed above, contact your doctor or||
2547|085|S|pharmacist.||
2547|086|S|   In the US -||
2547|087|S|   Call your doctor for medical advice about side effects. You||
2547|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2547|089|S|www.fda.gov/medwatch.||
2547|090|S|   In Canada - Call your doctor for medical advice about side||
2547|091|S|effects. You may report side effects to Health Canada at||
2547|092|S|1-866-234-2345.||
2547|093|B|||
2547|094|P|PRECAUTIONS:  See also Warning section.||
2547|095|P|   Before using zuranolone, tell your doctor or pharmacist if you||
2547|096|P|are allergic to it; or if you have any other allergies. This||
2547|097|P|product may contain inactive ingredients, which can cause||
2547|098|P|allergic reactions or other problems. Talk to your pharmacist for||
2547|099|P|more details.||
2547|100|P|   Before using this medication, tell your doctor or pharmacist||
2547|101|P|your medical history, especially of: kidney problems, liver||
2547|102|P|problems, personal or family history of a substance use disorder||
2547|103|P|(such as overuse of or addiction to drugs/alcohol).||
2547|104|P|   Before having surgery, tell your doctor or dentist about all||
2547|105|P|the products you use (including prescription drugs,||
2547|106|P|nonprescription drugs, and herbal products).||
2547|107|P|   Tell your doctor if you are pregnant or plan to become||
2547|108|P|pregnant. You should not become pregnant while using zuranolone.||
2547|109|P|Zuranolone may harm an unborn baby. Ask about reliable forms of||
2547|110|P|birth control while using this medication and for 1 week after||
2547|111|P|the last dose. If you become pregnant, talk to your doctor right||
2547|112|P|away about the risks and benefits of this medication.||
2547|113|P|   This medication passes into breast milk in small amounts.||
2547|114|P|Consult your doctor before breastfeeding.||
2547|115|B|||
2547|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2547|117|I|medications work or increase your risk for serious side effects.||
2547|118|I|This document does not contain all possible drug interactions.||
2547|119|I|Keep a list of all the products you use (including||
2547|120|I|prescription/nonprescription drugs and herbal products) and share||
2547|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
2547|122|I|the dosage of any medicines without your doctor's approval.||
2547|123|I|   The risk of serious side effects (such as slow/shallow||
2547|124|I|breathing, severe drowsiness/dizziness) may be increased if this||
2547|125|I|medication is taken with other products that may also cause||
2547|126|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
2547|127|I|if you are using other products such as opioid pain or cough||
2547|128|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2547|129|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2547|130|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2547|131|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2547|132|I|diphenhydramine).||
2547|133|I|   Check the labels on all your medicines (such as allergy or||
2547|134|I|cough-and-cold products) because they may contain ingredients||
2547|135|I|that cause drowsiness. Ask your pharmacist about using those||
2547|136|I|products safely.||
2547|137|B|||
2547|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2547|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2547|140|O|poison control center right away. US residents can call||
2547|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2547|142|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
2547|143|O|loss of consciousness.||
2547|144|B|||
2547|145|N|NOTES:  Do not share this medication with others. Sharing it is||
2547|146|N|against the law.||
2547|147|N|   Lab and/or medical tests (such as kidney/liver function)||
2547|148|N|should be done while you are using this medication. Keep all||
2547|149|N|medical and lab appointments.||
2547|150|B|||
2547|151|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2547|152|D|next dose at the regular time. Do not double the dose to catch||
2547|153|D|up.||
2547|154|B|||
2547|155|R|STORAGE:  Store at room temperature away from light and moisture.||
2547|156|R|Do not store in the bathroom. Keep all medications away from||
2547|157|R|children and pets.||
2547|158|R|   Do not flush medications down the toilet or pour them into a||
2547|159|R|drain unless instructed to do so. Properly discard this product||
2547|160|R|when it is expired or no longer needed. Consult your pharmacist||
2547|161|R|or local waste disposal company.||
2547|162|B|||
2547|163|A|Information last revised May 2024.||
2547|164|A|Copyright(c) 2025 First Databank, Inc.||
2547|165|B|||
2548|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2548|002|Z|does NOT have all possible information about this product. This||
2548|003|Z|information does not assure that this product is safe, effective,||
2548|004|Z|or appropriate for you. This information is not individual||
2548|005|Z|medical advice and does not substitute for the advice of your||
2548|006|Z|health care professional. Always ask your health care||
2548|007|Z|professional for complete information about this product and your||
2548|008|Z|specific health needs.||
2548|009|B|||
2548|010|T|FOSCARBIDOPA/FOSLEVODOPA - INJECTION||
2548|011|B|||
2548|012|C|COMMON BRAND NAME(S): Vyalev||
2548|013|B|||
2548|014|U|USES:  This combination medication is used to treat symptoms of||
2548|015|U|Parkinson's disease (such as shakiness, stiffness, difficulty||
2548|016|U|moving). It is used when other treatments for Parkinson's disease||
2548|017|U|are not working as well. Parkinson's disease is thought to be||
2548|018|U|caused by too little of a naturally occurring substance||
2548|019|U|(dopamine) in the brain. Foslevodopa changes into dopamine in the||
2548|020|U|brain, helping to control movement. Foscarbidopa prevents the||
2548|021|U|breakdown of foslevodopa in the bloodstream so more foslevodopa||
2548|022|U|can enter the brain. Foscarbidopa can also reduce some of||
2548|023|U|foslevodopa's side effects such as nausea and vomiting.||
2548|024|B|||
2548|025|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2548|026|H|Patient Information Leaflet and Instructions for Use provided by||
2548|027|H|your pharmacist before you start using foscarbidopa/foslevodopa||
2548|028|H|and each time you get a refill. Ask your health care professional||
2548|029|H|how to prepare and use this medication. If you have any||
2548|030|H|questions, ask your doctor or pharmacist.||
2548|031|H|   This medication is usually given as a continuous infusion||
2548|032|H|under the skin using an infusion pump as directed by your doctor.||
2548|033|H|The dosage is based on your medical condition and response to||
2548|034|H|treatment.||
2548|035|H|   Take the medication out of the refrigerator about 30 minutes||
2548|036|H|before use to allow it to reach room temperature. Do not warm up||
2548|037|H|this medication any other way (for example, do not heat it in the||
2548|038|H|microwave, place it in hot water, or leave it in direct||
2548|039|H|sunlight). Do not shake the medication. Before using, check this||
2548|040|H|product for cloudiness or particles. If either is present, do not||
2548|041|H|use the liquid. The color of the liquid may change but this does||
2548|042|H|not make the medication less effective. Learn how to store and||
2548|043|H|discard medical supplies safely.||
2548|044|H|   Do not stop using this medication without consulting your||
2548|045|H|doctor. Some conditions may become worse when this medication is||
2548|046|H|suddenly stopped. Also, if you suddenly stop using this||
2548|047|H|medication, you may have withdrawal symptoms (such as anxiety,||
2548|048|H|depression, confusion, fever, muscle stiffness). To help prevent||
2548|049|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
2548|050|H|more likely if you have used this medication for a long time or||
2548|051|H|in high doses. Tell your doctor or pharmacist right away if you||
2548|052|H|have withdrawal.||
2548|053|H|   Do not swim, bathe, or shower with the infusion pump. If you||
2548|054|H|plan to be disconnected from the pump for a short period of time||
2548|055|H|(less than 1 hour, for example, to shower), restart your infusion||
2548|056|H|pump at the usual dose as soon as possible. If you plan to be||
2548|057|H|disconnected from the pump for longer than 1 hour, ask your||
2548|058|H|doctor what you should do.||
2548|059|H|   Tell your doctor if your condition does not get better or if||
2548|060|H|it gets worse.||
2548|061|B|||
2548|062|S|SIDE EFFECTS:  Dizziness, lightheadedness, nausea, vomiting,||
2548|063|S|trouble sleeping, unusual dreams, or headache may occur. If any||
2548|064|S|of these effects last or get worse, tell your doctor or||
2548|065|S|pharmacist promptly.||
2548|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
2548|067|S|slowly when rising from a sitting or lying position.||
2548|068|S|   This medication may cause urine, sweat, or saliva to turn red,||
2548|069|S|brown, or black. This effect is harmless, but your clothes may||
2548|070|S|become stained.||
2548|071|S|   Remember that this medication has been prescribed because your||
2548|072|S|doctor has judged that the benefit to you is greater than the||
2548|073|S|risk of side effects. Many people using this medication do not||
2548|074|S|have serious side effects.||
2548|075|S|   Some people using this medication have fallen asleep suddenly||
2548|076|S|during their usual daily activities (such as talking on the||
2548|077|S|phone, driving). In some cases, sleep occurred without any||
2548|078|S|feelings of drowsiness beforehand. This sleep effect may occur||
2548|079|S|anytime during treatment with this medication even if you have||
2548|080|S|used this medication for a long time. If you experience increased||
2548|081|S|sleepiness or fall asleep during the day, do not drive or do||
2548|082|S|other possibly dangerous activities until you have discussed this||
2548|083|S|effect with your doctor. Your risk of this sleep effect is||
2548|084|S|increased by using alcohol or other medications that can make you||
2548|085|S|drowsy. See also Precautions section.||
2548|086|S|   Tell your doctor right away if you have any serious side||
2548|087|S|effects, including: new/worsening movements you can't||
2548|088|S|control/spasms, greatly increased eye blinking/twitching, vision||
2548|089|S|changes (such as blurred/double/decreased vision), eye pain,||
2548|090|S|mental/mood changes (such as confusion, agitation,||
2548|091|S|hallucinations), easy bruising/bleeding, unusual tiredness,||
2548|092|S|tingling/numbness/weakness of the hands/feet, unusual strong||
2548|093|S|urges (such as increased gambling, increased sexual urges), signs||
2548|094|S|of infection (such as sore throat that doesn't go away, fever,||
2548|095|S|chills), redness/swelling/pain/oozing around the infusion site.||
2548|096|S|   This medication may raise your blood pressure. Check your||
2548|097|S|blood pressure regularly and tell your doctor if the results are||
2548|098|S|high.||
2548|099|S|   Get medical help right away if you have any very serious side||
2548|100|S|effects, including: chest pain, fainting.||
2548|101|S|   Abruptly stopping or reducing the dose of this medication may||
2548|102|S|rarely cause a very serious condition called neuroleptic||
2548|103|S|malignant syndrome (NMS). Get medical help right away if you have||
2548|104|S|any of the following symptoms: fever, unusual muscle stiffness,||
2548|105|S|severe confusion, sweating, fast/irregular heartbeat.||
2548|106|S|   A very serious allergic reaction to this drug is rare.||
2548|107|S|However, get medical help right away if you notice any symptoms||
2548|108|S|of a serious allergic reaction, including: rash, itching/swelling||
2548|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2548|110|S|breathing.||
2548|111|S|   This is not a complete list of possible side effects. If you||
2548|112|S|notice other effects not listed above, contact your doctor or||
2548|113|S|pharmacist.||
2548|114|S|   In the US -||
2548|115|S|   Call your doctor for medical advice about side effects. You||
2548|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2548|117|S|www.fda.gov/medwatch.||
2548|118|S|   In Canada - Call your doctor for medical advice about side||
2548|119|S|effects. You may report side effects to Health Canada at||
2548|120|S|1-866-234-2345.||
2548|121|B|||
2548|122|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2548|123|P|pharmacist if you are allergic to foscarbidopa or foslevodopa; or||
2548|124|P|to carbidopa or levodopa; or if you have any other allergies.||
2548|125|P|This product may contain inactive ingredients, which can cause||
2548|126|P|allergic reactions or other problems. Talk to your pharmacist for||
2548|127|P|more details.||
2548|128|P|   Before using this medication, tell your doctor or pharmacist||
2548|129|P|your medical history, especially of: liver disease, glaucoma,||
2548|130|P|breathing problems (such as asthma), heart disease (such as||
2548|131|P|irregular heartbeat, heart attack), kidney disease,||
2548|132|P|stomach/intestinal ulcers, mental/mood disorders (such as||
2548|133|P|depression, schizophrenia), blood disorders, seizures, sleep||
2548|134|P|disorder, high blood pressure, numbness/tingling of the||
2548|135|P|hands/feet.||
2548|136|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2548|137|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2548|138|P|machinery, or do anything that needs alertness until you can do||
2548|139|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2548|140|P|are using marijuana (cannabis). See also Side Effects section.||
2548|141|P|   This medication contains sodium. Ask your doctor or pharmacist||
2548|142|P|for more information if you are on a salt-restricted diet or if||
2548|143|P|you have a condition that could be worsened by an increase in||
2548|144|P|salt intake (such as heart failure).||
2548|145|P|   Before having surgery, tell your doctor or dentist about all||
2548|146|P|the products you use (including prescription drugs,||
2548|147|P|nonprescription drugs, and herbal products).||
2548|148|P|   During pregnancy, this medication should be used only when||
2548|149|P|clearly needed. Discuss the risks and benefits with your doctor.||
2548|150|P|   Foslevodopa passes into breast milk. It is unknown if||
2548|151|P|foscarbidopa passes into breast milk. Consult your doctor before||
2548|152|P|breastfeeding.||
2548|153|B|||
2548|154|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2548|155|I|medications work or increase your risk for serious side effects.||
2548|156|I|This document does not contain all possible drug interactions.||
2548|157|I|Keep a list of all the products you use (including||
2548|158|I|prescription/nonprescription drugs and herbal products) and share||
2548|159|I|it with your doctor and pharmacist. Do not start, stop, or change||
2548|160|I|the dosage of any medicines without your doctor's approval.||
2548|161|I|   Taking MAO inhibitors with this medication may cause a serious||
2548|162|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2548|163|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2548|164|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
2548|165|I|treatment with this medication. Most MAO inhibitors should also||
2548|166|I|not be taken for two weeks before treatment with this medication.||
2548|167|I|However, certain MAO inhibitors (rasagiline, safinamide,||
2548|168|I|selegiline) may be used with careful monitoring by your doctor.||
2548|169|I|Ask your doctor when to start or stop taking this medication.||
2548|170|I|   This medication may interfere with certain lab tests (such as||
2548|171|I|urine catecholamine/glucose/ketone tests), possibly causing false||
2548|172|I|test results. Make sure lab personnel and all your doctors know||
2548|173|I|you use this drug.||
2548|174|B|||
2548|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2548|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2548|177|O|poison control center right away. US residents can call||
2548|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2548|179|O|Symptoms of overdose may include: severe dizziness, irregular||
2548|180|O|heartbeat, mental/mood changes (such as agitation).||
2548|181|B|||
2548|182|N|NOTES:  Do not share this medication with others.||
2548|183|N|   Lab and/or medical tests (such as complete blood count,||
2548|184|N|heart/kidney/liver function, blood pressure) should be done while||
2548|185|N|you are using this medication. Keep all medical and lab||
2548|186|N|appointments. Consult your doctor for more details.||
2548|187|B|||
2548|188|D|MISSED DOSE:  This drug is to be given continuously as an||
2548|189|D|infusion. If your infusion is interrupted for more than 1 hour,||
2548|190|D|contact your doctor or pharmacist right away.||
2548|191|B|||
2548|192|R|STORAGE:  Store in the refrigerator away from light. Do not||
2548|193|R|freeze. This medication may also be stored at room temperature if||
2548|194|R|needed. If the medication is stored at room temperature, do not||
2548|195|R|put it back in the refrigerator and discard after 28 days. Keep||
2548|196|R|all medications away from children and pets.||
2548|197|R|   Do not flush medications down the toilet or pour them into a||
2548|198|R|drain unless instructed to do so. Properly discard this product||
2548|199|R|when it is expired or no longer needed. Consult your pharmacist||
2548|200|R|or local waste disposal company.||
2548|201|B|||
2548|202|A|Information last revised April 2025.||
2548|203|A|Copyright(c) 2025 First Databank, Inc.||
2548|204|B|||
2549|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2549|002|Z|does NOT have all possible information about this product. This||
2549|003|Z|information does not assure that this product is safe, effective,||
2549|004|Z|or appropriate for you. This information is not individual||
2549|005|Z|medical advice and does not substitute for the advice of your||
2549|006|Z|health care professional. Always ask your health care||
2549|007|Z|professional for complete information about this product and your||
2549|008|Z|specific health needs.||
2549|009|B|||
2549|010|T|TIRZEPATIDE (WEIGHT LOSS) - INJECTION||
2549|011|F|(tir-ZEP-a-tide)||
2549|012|B|||
2549|013|C|COMMON BRAND NAME(S): Zepbound||
2549|014|B|||
2549|015|W|WARNING:  This medication can cause a certain type of thyroid||
2549|016|W|tumor (thyroid C-cell tumors) in rats. It is unknown if this||
2549|017|W|medication can cause similar tumors in humans. Talk with your||
2549|018|W|doctor about the benefits and risks of treatment with this||
2549|019|W|medication. Do not use this medication if you have a||
2549|020|W|personal/family history of a certain type of cancer (medullary||
2549|021|W|thyroid carcinoma) or a certain inherited disease (multiple||
2549|022|W|endocrine neoplasia syndrome type 2 or MEN 2). While using this||
2549|023|W|medication, tell your doctor right away if you notice any signs||
2549|024|W|of thyroid tumors, including an unusual growth or lump in the||
2549|025|W|neck, difficulty swallowing, shortness of breath, unusual/lasting||
2549|026|W|hoarseness.||
2549|027|B|||
2549|028|U|USES:  This medication is used with a doctor-approved exercise,||
2549|029|U|behavior change, and reduced-calorie diet program to help you||
2549|030|U|lose weight. It is used by certain overweight people, such as||
2549|031|U|those who are obese or have weight-related medical problems||
2549|032|U|(including sleep apnea). Losing weight and keeping it off can||
2549|033|U|lessen the many health risks that come with obesity, including||
2549|034|U|heart disease, diabetes, high blood pressure, and a shorter life.||
2549|035|U|   Tirzepatide is similar to a natural hormone in your body||
2549|036|U|(incretin). It works by controlling your appetite.||
2549|037|B|||
2549|038|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2549|039|H|provided by your pharmacist before you start using tirzepatide||
2549|040|H|and each time you get a refill. Ask your health care professional||
2549|041|H|how to prepare and use this medication. If you have any||
2549|042|H|questions, ask your doctor or pharmacist.||
2549|043|H|   Inject this medication under the skin as directed by your||
2549|044|H|doctor, usually once every 7 days. The injection is given in the||
2549|045|H|thigh, abdomen, or upper arm. This medication may be used with or||
2549|046|H|without meals. The dosage is based on your medical condition and||
2549|047|H|response to treatment. To reduce your risk of side effects, your||
2549|048|H|doctor may direct you to start this medication at a low dose and||
2549|049|H|gradually increase your dose. Follow your doctor's instructions||
2549|050|H|carefully.||
2549|051|H|   Before using, check this product for particles or||
2549|052|H|discoloration. If either is present, do not use the liquid.||
2549|053|H|Before injecting each dose, clean the skin you are going to||
2549|054|H|inject into (the injection site) with rubbing alcohol. Change the||
2549|055|H|injection site each time to lessen injury under the skin. Do not||
2549|056|H|inject into skin that is tender, bruised, red, hard, or has scars||
2549|057|H|or stretch marks. To lessen bruising, do not rub the injection||
2549|058|H|site after a shot. Learn how to store and discard medical||
2549|059|H|supplies safely.||
2549|060|H|   Use this medication regularly to get the most benefit from it.||
2549|061|H|To help you remember, mark your calendar with a reminder. If||
2549|062|H|needed, the day of weekly use may be changed as long as the time||
2549|063|H|between two doses is at least 3 days (72 hours). Carefully follow||
2549|064|H|the medication treatment plan, meal plan, and exercise program||
2549|065|H|your doctor has recommended.||
2549|066|B|||
2549|067|S|SIDE EFFECTS:  See also Warning section.||
2549|068|S|   Swelling/redness/itching at the injection site, tiredness,||
2549|069|S|nausea, vomiting, stomach upset, diarrhea, dizziness, or||
2549|070|S|constipation may occur. Nausea usually lessens as you continue to||
2549|071|S|use tirzepatide. If any of these effects last or get worse, tell||
2549|072|S|your doctor or pharmacist promptly.||
2549|073|S|   Remember that this medication has been prescribed because your||
2549|074|S|doctor has judged that the benefit to you is greater than the||
2549|075|S|risk of side effects. Many people using this medication do not||
2549|076|S|have serious side effects.||
2549|077|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2549|078|S|Contact your doctor promptly if you notice any symptoms of||
2549|079|S|dehydration, such as unusual dry mouth/thirst, fast heartbeat, or||
2549|080|S|dizziness/lightheadedness.||
2549|081|S|   Tell your doctor right away if you have any serious side||
2549|082|S|effects, including: signs of kidney problems (such as change in||
2549|083|S|the amount of urine), vision changes (such as decreased/blurred||
2549|084|S|vision), mental/mood changes (such as depression, thoughts of||
2549|085|S|suicide), signs of low blood sugar (sudden sweating, shaking,||
2549|086|S|fast heartbeat, hunger, blurred vision, dizziness, tingling||
2549|087|S|hands/feet).||
2549|088|S|   Get medical help right away if you have any very serious side||
2549|089|S|effects, including: signs of pancreas or gallbladder disease||
2549|090|S|(such as nausea/vomiting that doesn't stop, severe||
2549|091|S|stomach/abdominal pain).||
2549|092|S|   A very serious allergic reaction to this drug is rare.||
2549|093|S|However, get medical help right away if you notice any symptoms||
2549|094|S|of a serious allergic reaction, including: rash, itching/swelling||
2549|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2549|096|S|breathing.||
2549|097|S|   This is not a complete list of possible side effects. If you||
2549|098|S|notice other effects not listed above, contact your doctor or||
2549|099|S|pharmacist.||
2549|100|S|   In the US -||
2549|101|S|   Call your doctor for medical advice about side effects. You||
2549|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2549|103|S|www.fda.gov/medwatch.||
2549|104|S|   In Canada - Call your doctor for medical advice about side||
2549|105|S|effects. You may report side effects to Health Canada at||
2549|106|S|1-866-234-2345.||
2549|107|B|||
2549|108|P|PRECAUTIONS:  See also Warning section.||
2549|109|P|   Before using tirzepatide, tell your doctor or pharmacist if||
2549|110|P|you are allergic to it; or if you have any other allergies. This||
2549|111|P|product may contain inactive ingredients (such as benzyl alcohol||
2549|112|P|found in some brands), which can cause allergic reactions or||
2549|113|P|other problems. Talk to your pharmacist for more details.||
2549|114|P|   Before using this medication, tell your doctor or pharmacist||
2549|115|P|your medical history, especially of: a certain eye problem||
2549|116|P|(diabetic retinopathy), a disease of the pancreas (pancreatitis),||
2549|117|P|gallbladder disease, kidney problems, mental/mood disorders (such||
2549|118|P|as depression, thoughts of suicide), stomach/intestinal disorders||
2549|119|P|(such as gastroparesis, digestion problems).||
2549|120|P|   If you have diabetes, this product may affect your blood||
2549|121|P|sugar. Check your blood sugar regularly as directed and share the||
2549|122|P|results with your doctor. Tell your doctor right away if you have||
2549|123|P|symptoms of low blood sugar (see also Side Effects section). Your||
2549|124|P|doctor may need to adjust your diabetes medication(s), exercise||
2549|125|P|program, or diet.||
2549|126|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2549|127|P|can make you more dizzy. Do not drive, use machinery, or do||
2549|128|P|anything that needs alertness until you can do it safely. Limit||
2549|129|P|alcoholic beverages. Talk to your doctor if you are using||
2549|130|P|marijuana (cannabis).||
2549|131|P|   Before having surgery, tell your doctor or dentist about all||
2549|132|P|the products you use (including prescription drugs,||
2549|133|P|nonprescription drugs, and herbal products).||
2549|134|P|   This medication must not be used during pregnancy. It may harm||
2549|135|P|an unborn baby. If you become pregnant or think you may be||
2549|136|P|pregnant, tell your doctor right away.||
2549|137|P|   This medication passes into breast milk. Consult your doctor||
2549|138|P|before breastfeeding.||
2549|139|B|||
2549|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2549|141|I|medications work or increase your risk for serious side effects.||
2549|142|I|This document does not contain all possible drug interactions.||
2549|143|I|Keep a list of all the products you use (including||
2549|144|I|prescription/nonprescription drugs and herbal products) and share||
2549|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
2549|146|I|the dosage of any medicines without your doctor's approval.||
2549|147|I|   Do not use this medication with any other product that||
2549|148|I|contains tirzepatide or other medications which are similar to||
2549|149|I|this medication (such as dulaglutide, liraglutide, semaglutide).||
2549|150|I|   This medication may decrease the effectiveness of hormonal||
2549|151|I|birth control pills, especially when you first start treatment||
2549|152|I|and when the dose is increased. This could cause pregnancy.||
2549|153|I|Discuss with your doctor or pharmacist if you should use reliable||
2549|154|I|backup birth control methods for 4 weeks after starting this||
2549|155|I|medication and for 4 weeks after each increase in dose of||
2549|156|I|tirzepatide. Also tell your doctor if you have any new spotting||
2549|157|I|or breakthrough bleeding, because these may be signs that your||
2549|158|I|birth control pills are not working well.||
2549|159|B|||
2549|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2549|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2549|162|O|poison control center right away. US residents can call||
2549|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2549|164|B|||
2549|165|N|NOTES:  Do not share this medication with others.||
2549|166|N|   Lab and/or medical tests (such as kidney function, blood||
2549|167|N|glucose, weight) should be done while you are using this||
2549|168|N|medication. Keep all medical and lab appointments. Consult your||
2549|169|N|doctor for more details.||
2549|170|B|||
2549|171|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2549|172|D|If it is more than 4 days (96 hours) after the missed dose, skip||
2549|173|D|the missed dose. Use your next dose at the regular time. Do not||
2549|174|D|double the dose to catch up.||
2549|175|B|||
2549|176|R|STORAGE:  Different brands of this medication have different||
2549|177|R|storage needs. Check the product package for instructions on how||
2549|178|R|to store your brand, or ask your pharmacist. Keep all medications||
2549|179|R|away from children and pets.||
2549|180|R|   Do not flush medications down the toilet or pour them into a||
2549|181|R|drain unless instructed to do so. Properly discard this product||
2549|182|R|when it is expired or no longer needed. Consult your pharmacist||
2549|183|R|or local waste disposal company.||
2549|184|B|||
2549|185|A|Information last revised September 2025.||
2549|186|A|Copyright(c) 2025 First Databank, Inc.||
2549|187|B|||
2550|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2550|002|Z|does NOT have all possible information about this product. This||
2550|003|Z|information does not assure that this product is safe, effective,||
2550|004|Z|or appropriate for you. This information is not individual||
2550|005|Z|medical advice and does not substitute for the advice of your||
2550|006|Z|health care professional. Always ask your health care||
2550|007|Z|professional for complete information about this product and your||
2550|008|Z|specific health needs.||
2550|009|B|||
2550|010|T|FRUQUINTINIB - ORAL||
2550|011|B|||
2550|012|C|COMMON BRAND NAME(S): Fruzaqla||
2550|013|B|||
2550|014|U|USES:  This medication is used to treat cancer of the colon and||
2550|015|U|rectum. Fruquintinib belongs to a class of drugs known as kinase||
2550|016|U|inhibitors. It works by slowing or stopping the growth of cancer||
2550|017|U|cells.||
2550|018|B|||
2550|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2550|020|H|from your pharmacist before you start taking fruquintinib and||
2550|021|H|each time you get a refill. If you have any questions, ask your||
2550|022|H|doctor or pharmacist.||
2550|023|H|   Take this medication by mouth with or without food as directed||
2550|024|H|by your doctor, usually once daily for 21 days, followed by 7||
2550|025|H|days off treatment. Repeat this treatment cycle for as long as||
2550|026|H|directed by your doctor. Swallow the capsules whole. The dosage||
2550|027|H|is based on your medical condition and response to treatment.||
2550|028|H|   If you vomit after taking a dose, do not take another dose.||
2550|029|H|Take your next dose at the regular time.||
2550|030|H|   Use this medication regularly to get the most benefit from it.||
2550|031|H|To help you remember, take it at the same time each day.||
2550|032|H|   Do not increase your dose or use this drug more often or for||
2550|033|H|longer than prescribed. Your condition will not improve any||
2550|034|H|faster, and your risk of serious side effects will increase.||
2550|035|H|   Since this drug can be absorbed through the skin and lungs and||
2550|036|H|may harm an unborn baby, women who are pregnant or who may become||
2550|037|H|pregnant should not handle this medication or breathe the dust||
2550|038|H|from the capsules.||
2550|039|B|||
2550|040|S|SIDE EFFECTS:  Diarrhea, hoarseness, or tiredness may occur. If||
2550|041|S|any of these effects last or get worse, tell your doctor or||
2550|042|S|pharmacist promptly.||
2550|043|S|   People using this medication may have serious side effects.||
2550|044|S|However, you have been prescribed this drug because your doctor||
2550|045|S|has judged that the benefit to you is greater than the risk of||
2550|046|S|side effects. Careful monitoring by your doctor may decrease your||
2550|047|S|risk.||
2550|048|S|   This medication may raise your blood pressure. Check your||
2550|049|S|blood pressure regularly and tell your doctor if the results are||
2550|050|S|high.||
2550|051|S|   Tell your doctor right away if you have any serious side||
2550|052|S|effects, including: easy bruising/bleeding, swelling||
2550|053|S|hands/feet/legs, signs of liver problems (such as nausea/vomiting||
2550|054|S|that doesn't stop, loss of appetite, yellowing eyes/skin, dark||
2550|055|S|urine), slow wound healing.||
2550|056|S|   Get medical help right away if you have any very serious side||
2550|057|S|effects, including: symptoms of a heart attack (such as||
2550|058|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
2550|059|S|signs of a stroke (such as weakness on one side of the body,||
2550|060|S|trouble speaking, sudden vision changes, confusion), pink/bloody||
2550|061|S|urine.||
2550|062|S|   This medication may lower your ability to fight infections.||
2550|063|S|This may make you more likely to get a serious (rarely fatal)||
2550|064|S|infection or make any infection you have worse. Tell your doctor||
2550|065|S|right away if you have any signs of infection (such as sore||
2550|066|S|throat that doesn't go away, fever, chills,||
2550|067|S|burning/frequent/painful/urgent urination).||
2550|068|S|   This medication can also cause serious (possibly fatal)||
2550|069|S|bleeding, such as bleeding from the stomach/intestines. You||
2550|070|S|should not receive this medication if you have any serious||
2550|071|S|bleeding problems. In addition, this medication can rarely cause||
2550|072|S|a tear in the stomach/intestines (gastrointestinal perforation).||
2550|073|S|Get medical help right away if you have any signs of these||
2550|074|S|serious side effects, including stomach/abdominal pain that is||
2550|075|S|severe or doesn't go away, bloody or black/tarry stools, vomit||
2550|076|S|that is bloody or looks like coffee grounds, coughing up blood,||
2550|077|S|dizziness/fainting.||
2550|078|S|   Treatment with this drug may sometimes cause your hands/feet||
2550|079|S|to develop a skin reaction called hand-foot skin reaction||
2550|080|S|(palmar-plantar erythrodysesthesia). Tell your doctor right away||
2550|081|S|if you experience swelling, pain, redness, peeling, blisters, or||
2550|082|S|tingling/burning of the hands/feet. Depending on how severe your||
2550|083|S|hand-foot reaction is, your doctor may lower your dose or delay||
2550|084|S|your treatment.||
2550|085|S|   Rarely, fruquintinib may cause a condition called PRES||
2550|086|S|(posterior reversible encephalopathy syndrome). Get medical help||
2550|087|S|right away if you develop headache that doesn't go away,||
2550|088|S|seizures, sudden vision changes, mental/mood changes (such as||
2550|089|S|confusion).||
2550|090|S|   A very serious allergic reaction to this drug is rare.||
2550|091|S|However, get medical help right away if you notice any symptoms||
2550|092|S|of a serious allergic reaction, including: rash, itching/swelling||
2550|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2550|094|S|breathing.||
2550|095|S|   This is not a complete list of possible side effects. If you||
2550|096|S|notice other effects not listed above, contact your doctor or||
2550|097|S|pharmacist.||
2550|098|S|   In the US -||
2550|099|S|   Call your doctor for medical advice about side effects. You||
2550|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2550|101|S|www.fda.gov/medwatch.||
2550|102|S|   In Canada - Call your doctor for medical advice about side||
2550|103|S|effects. You may report side effects to Health Canada at||
2550|104|S|1-866-234-2345.||
2550|105|B|||
2550|106|P|PRECAUTIONS:  Before taking fruquintinib, tell your doctor or||
2550|107|P|pharmacist if you are allergic to it; or if you have any other||
2550|108|P|allergies. This product may contain inactive ingredients (such as||
2550|109|P|tartrazine or sunset yellow), which can cause allergic reactions||
2550|110|P|or other problems. Talk to your pharmacist for more details.||
2550|111|P|   Before using this medication, tell your doctor or pharmacist||
2550|112|P|your medical history, especially of: bleeding/blood problems,||
2550|113|P|heart problems (such as heart failure, heart attack), current||
2550|114|P|infection, stroke/transient ischemic attack- TIA, high blood||
2550|115|P|pressure, kidney problems, liver problems.||
2550|116|P|   Fruquintinib can make you more likely to get infections or may||
2550|117|P|make current infections worse. Stay away from anyone who has an||
2550|118|P|infection that may easily spread (such as chickenpox, COVID-19,||
2550|119|P|measles, flu). Talk to your doctor if you have been exposed to an||
2550|120|P|infection or for more details.||
2550|121|P|   Tell your health care professional that you are using||
2550|122|P|fruquintinib before having any immunizations/vaccinations. Avoid||
2550|123|P|contact with people who have recently received live vaccines||
2550|124|P|(such as flu vaccine inhaled through the nose).||
2550|125|P|   To lower the chance of getting cut, bruised, or injured, use||
2550|126|P|caution with sharp objects like razors and nail cutters, and||
2550|127|P|avoid activities such as contact sports.||
2550|128|P|   Before having surgery, tell your doctor or dentist about all||
2550|129|P|the products you use (including prescription drugs,||
2550|130|P|nonprescription drugs, and herbal products). Your doctor or||
2550|131|P|dentist may tell you to not take fruquintinib for at least 2||
2550|132|P|weeks before and after surgery. This medication may cause wounds||
2550|133|P|to heal more slowly. Follow all instructions about when to stop||
2550|134|P|or restart this medication.||
2550|135|P|   Since this drug can be absorbed through the skin and lungs and||
2550|136|P|may harm an unborn baby, women who are pregnant or who may become||
2550|137|P|pregnant should not handle this medication or breathe the dust||
2550|138|P|from the capsules.||
2550|139|P|   Tell your doctor if you are pregnant or plan to become||
2550|140|P|pregnant. You should not become pregnant while using||
2550|141|P|fruquintinib. Fruquintinib may harm an unborn baby. Your doctor||
2550|142|P|should order a pregnancy test before you start this medication.||
2550|143|P|Men and women using this medication should ask about reliable||
2550|144|P|forms of birth control during treatment and for 2 weeks after the||
2550|145|P|last dose. If you or your partner becomes pregnant, talk to your||
2550|146|P|doctor right away about the risks and benefits of this||
2550|147|P|medication.||
2550|148|P|   It is unknown if this drug passes into breast milk. Because of||
2550|149|P|the possible risk to the infant, breastfeeding is not recommended||
2550|150|P|while using this drug and for 2 weeks after the last dose.||
2550|151|P|Consult your doctor before breastfeeding.||
2550|152|B|||
2550|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2550|154|I|medications work or increase your risk for serious side effects.||
2550|155|I|This document does not contain all possible drug interactions.||
2550|156|I|Keep a list of all the products you use (including||
2550|157|I|prescription/nonprescription drugs and herbal products) and share||
2550|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
2550|159|I|the dosage of any medicines without your doctor's approval.||
2550|160|I|   Some products that may interact with this drug include: other||
2550|161|I|drugs that can cause bleeding/bruising (including antiplatelet||
2550|162|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
2550|163|I|"blood thinners" such as warfarin/dabigatran).||
2550|164|I|   Aspirin can increase the risk of bleeding when used with this||
2550|165|I|medication. However, if your doctor has told you to take low-dose||
2550|166|I|aspirin to prevent heart attack or stroke (usually 81-162||
2550|167|I|milligrams a day), you should keep taking the aspirin unless your||
2550|168|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2550|169|I|details.||
2550|170|I|   Other medications can affect the removal of fruquintinib from||
2550|171|I|your body, which may affect how fruquintinib works. Examples||
2550|172|I|include rifamycins (such as rifampin), certain drugs used to||
2550|173|I|treat seizures (such as carbamazepine, phenytoin), St. John's||
2550|174|I|wort, among others.||
2550|175|B|||
2550|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2550|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2550|178|O|poison control center right away. US residents can call||
2550|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2550|180|B|||
2550|181|N|NOTES:  Do not share this medication with others.||
2550|182|N|   Lab and/or medical tests (such as complete blood count, liver||
2550|183|N|function, urine protein, skin exam, heart function) should be||
2550|184|N|done before you start taking this medication and while you are||
2550|185|N|taking it. Keep all medical and lab appointments. Consult your||
2550|186|N|doctor for more details.||
2550|187|B|||
2550|188|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2550|189|D|remember. If it is more than 12 hours after the missed dose, skip||
2550|190|D|the missed dose. Take your next dose at the regular time. Do not||
2550|191|D|double the dose to catch up.||
2550|192|B|||
2550|193|R|STORAGE:  Store at room temperature away from light and moisture.||
2550|194|R|Do not store in the bathroom. Keep all medications away from||
2550|195|R|children and pets.||
2550|196|R|   Do not flush medications down the toilet or pour them into a||
2550|197|R|drain unless instructed to do so. Properly discard this product||
2550|198|R|when it is expired or no longer needed. Consult your pharmacist||
2550|199|R|or local waste disposal company.||
2550|200|B|||
2550|201|M|MEDICAL ALERT:  Your condition can cause complications in a||
2550|202|M|medical emergency. For information about enrolling in MedicAlert,||
2550|203|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2550|204|B|||
2550|205|A|Information last revised April 2025.||
2550|206|A|Copyright(c) 2025 First Databank, Inc.||
2550|207|B|||
2551|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2551|002|Z|does NOT have all possible information about this product. This||
2551|003|Z|information does not assure that this product is safe, effective,||
2551|004|Z|or appropriate for you. This information is not individual||
2551|005|Z|medical advice and does not substitute for the advice of your||
2551|006|Z|health care professional. Always ask your health care||
2551|007|Z|professional for complete information about this product and your||
2551|008|Z|specific health needs.||
2551|009|B|||
2551|010|T|REPOTRECTINIB - ORAL||
2551|011|F|(RE-poe-TREK-ti-nib)||
2551|012|B|||
2551|013|C|COMMON BRAND NAME(S): Augtyro||
2551|014|B|||
2551|015|U|USES:  This medication is used to treat cancer. Repotrectinib||
2551|016|U|works by slowing or stopping the growth of cancer cells. It||
2551|017|U|belongs to a class of drugs known as kinase inhibitors.||
2551|018|B|||
2551|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2551|020|H|from your pharmacist before you start taking repotrectinib and||
2551|021|H|each time you get a refill. If you have any questions, ask your||
2551|022|H|doctor or pharmacist.||
2551|023|H|   Take this medication by mouth with or without food as directed||
2551|024|H|by your doctor, usually twice a day. To reduce your risk of side||
2551|025|H|effects, your doctor may direct you to take this medication once||
2551|026|H|a day when starting this medication, and then increase to twice a||
2551|027|H|day. Follow your doctor's instructions carefully.||
2551|028|H|   Swallow the capsules whole. Do not open, crush, chew, or||
2551|029|H|dissolve the capsules. Do not take capsules that look broken or||
2551|030|H|cracked.||
2551|031|H|   The dosage is based on your medical condition and response to||
2551|032|H|treatment.||
2551|033|H|   Take this medication regularly to get the most benefit from||
2551|034|H|it. To help you remember, take it at the same times each day.||
2551|035|H|   Do not increase your dose or use this drug more often or for||
2551|036|H|longer than prescribed. Your condition will not improve any||
2551|037|H|faster, and your risk of serious side effects will increase.||
2551|038|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2551|039|H|using this medication unless your doctor or pharmacist says you||
2551|040|H|may do so safely. Grapefruit can increase the chance of side||
2551|041|H|effects with this medicine. Ask your doctor or pharmacist for||
2551|042|H|more details.||
2551|043|H|   If you vomit your dose of repotrectinib, do not take another||
2551|044|H|dose. Take your next dose at your regular scheduled time. Do not||
2551|045|H|take two doses at the same time.||
2551|046|H|   Since this drug can be absorbed through the skin and lungs and||
2551|047|H|may harm an unborn baby, women who are pregnant or who may become||
2551|048|H|pregnant should not handle this medication or breathe the dust||
2551|049|H|from the capsules.||
2551|050|B|||
2551|051|S|SIDE EFFECTS:  Dizziness, tiredness, drowsiness, sleep problems,||
2551|052|S|blurred vision, constipation, nausea, or changes in taste may||
2551|053|S|occur. If any of these effects last or get worse, tell your||
2551|054|S|doctor or pharmacist promptly.||
2551|055|S|   People using this medication may have serious side effects.||
2551|056|S|However, you have been prescribed this drug because your doctor||
2551|057|S|has judged that the benefit to you is greater than the risk of||
2551|058|S|side effects. Careful monitoring by your doctor may decrease your||
2551|059|S|risk.||
2551|060|S|   Tell your doctor right away if you have any serious side||
2551|061|S|effects, including: mental/mood changes (such as confusion,||
2551|062|S|anxiety, depression, trouble paying attention, memory problems),||
2551|063|S|unsteadiness, loss of coordination, numbness/tingling of||
2551|064|S|arms/legs, new or worsening lung problems (such as shortness of||
2551|065|S|breath, cough), signs of liver disease (such as nausea/vomiting||
2551|066|S|that doesn't stop, loss of appetite, stomach/abdominal pain,||
2551|067|S|yellowing eyes/skin, dark urine), muscle||
2551|068|S|pain/tenderness/weakness, signs of high uric acid level in the||
2551|069|S|blood (such as toe/joint pain, painful urination, change in the||
2551|070|S|amount of urine).||
2551|071|S|   This medication may increase your risk for bone fractures.||
2551|072|S|Fractures may happen with or without a fall or injury. Tell your||
2551|073|S|doctor right away if you have bone pain or changes in movement.||
2551|074|S|   This medication decreases bone marrow function, an effect that||
2551|075|S|may lead to a low number of blood cells such as red cells, white||
2551|076|S|cells, and platelets. This effect can cause anemia, decrease your||
2551|077|S|body's ability to fight an infection, or cause easy||
2551|078|S|bruising/bleeding. Tell your doctor right away if you develop any||
2551|079|S|of the following unlikely symptoms: unusual tiredness, pale skin,||
2551|080|S|signs of infection (such as sore throat that doesn't go away,||
2551|081|S|fever, chills), easy bruising/bleeding.||
2551|082|S|   A very serious allergic reaction to this drug is rare.||
2551|083|S|However, get medical help right away if you notice any symptoms||
2551|084|S|of a serious allergic reaction, including: rash, itching/swelling||
2551|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2551|086|S|breathing.||
2551|087|S|   This is not a complete list of possible side effects. If you||
2551|088|S|notice other effects not listed above, contact your doctor or||
2551|089|S|pharmacist.||
2551|090|S|   In the US -||
2551|091|S|   Call your doctor for medical advice about side effects. You||
2551|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2551|093|S|www.fda.gov/medwatch.||
2551|094|S|   In Canada - Call your doctor for medical advice about side||
2551|095|S|effects. You may report side effects to Health Canada at||
2551|096|S|1-866-234-2345.||
2551|097|B|||
2551|098|P|PRECAUTIONS:  Before taking repotrectinib, tell your doctor or||
2551|099|P|pharmacist if you are allergic to it; or if you have any other||
2551|100|P|allergies. This product may contain inactive ingredients, which||
2551|101|P|can cause allergic reactions or other problems. Talk to your||
2551|102|P|pharmacist for more details.||
2551|103|P|   Before using this medication, tell your doctor or pharmacist||
2551|104|P|your medical history, especially of: liver disease, kidney||
2551|105|P|disease.||
2551|106|P|   This drug may make you dizzy or drowsy or cause blurred||
2551|107|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
2551|108|P|or drowsy. Do not drive, use machinery, or do anything that needs||
2551|109|P|alertness or clear vision until you can do it safely. Limit||
2551|110|P|alcoholic beverages. Talk to your doctor if you are using||
2551|111|P|marijuana (cannabis).||
2551|112|P|   Before having surgery, tell your doctor or dentist about all||
2551|113|P|the products you use (including prescription drugs,||
2551|114|P|nonprescription drugs, and herbal products).||
2551|115|P|   Since this drug can be absorbed through the skin and lungs and||
2551|116|P|may harm an unborn baby, women who are pregnant or who may become||
2551|117|P|pregnant should not handle this medication or breathe the dust||
2551|118|P|from the capsules.||
2551|119|P|   Tell your doctor if you are pregnant or plan to become||
2551|120|P|pregnant. You should not become pregnant while using||
2551|121|P|repotrectinib. Repotrectinib may harm an unborn baby. Your doctor||
2551|122|P|should order a pregnancy test before you start this medication.||
2551|123|P|Women using this medication should ask about reliable forms of||
2551|124|P|non-hormonal birth control during treatment and for 2 months||
2551|125|P|after the last dose. Men using this medication should ask about||
2551|126|P|reliable forms of birth control during treatment and for 4 months||
2551|127|P|after the last dose. If you or your partner becomes pregnant,||
2551|128|P|talk to your doctor right away about the risks and benefits of||
2551|129|P|this medication.||
2551|130|P|   It is unknown if this drug passes into breast milk. Because of||
2551|131|P|the possible risk to the infant, breastfeeding is not recommended||
2551|132|P|while using this drug and for 10 days after the last dose.||
2551|133|P|Consult your doctor before breastfeeding.||
2551|134|B|||
2551|135|I|DRUG INTERACTIONS:  See also How to Use section.||
2551|136|I|   Drug interactions may change how your medications work or||
2551|137|I|increase your risk for serious side effects. This document does||
2551|138|I|not contain all possible drug interactions. Keep a list of all||
2551|139|I|the products you use (including prescription/nonprescription||
2551|140|I|drugs and herbal products) and share it with your doctor and||
2551|141|I|pharmacist. Do not start, stop, or change the dosage of any||
2551|142|I|medicines without your doctor's approval.||
2551|143|I|   Other medications can affect the removal of repotrectinib from||
2551|144|I|your body, which may affect how repotrectinib works. Examples||
2551|145|I|include adagrasib, azole antifungals (such as itraconazole,||
2551|146|I|ketoconazole), cobicistat, macrolide antibiotics (such as||
2551|147|I|clarithromycin, erythromycin), mifepristone, rifamycins (such as||
2551|148|I|rifampin, rifabutin), drugs used to treat seizures (such as||
2551|149|I|phenytoin, carbamazepine), St. John's wort, among others.||
2551|150|I|   Repotrectinib can speed up the removal of other drugs from||
2551|151|I|your body, which may affect how they work. Examples of affected||
2551|152|I|drugs include lonafarnib, mavacamten, revumenib, among others.||
2551|153|I|   This medication may decrease the effectiveness of hormonal||
2551|154|I|birth control such as pills, patch, or ring. This could cause||
2551|155|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2551|156|I|use reliable backup birth control methods while using this||
2551|157|I|medication. Also tell your doctor if you have any new spotting or||
2551|158|I|breakthrough bleeding, because these may be signs that your birth||
2551|159|I|control is not working well.||
2551|160|B|||
2551|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2551|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2551|163|O|poison control center right away. US residents can call||
2551|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2551|165|B|||
2551|166|N|NOTES:  Do not share this medication with others.||
2551|167|N|   Lab and/or medical tests (such as liver function, uric acid||
2551|168|N|level) should be done before you start taking this medication and||
2551|169|N|while you are taking it. Keep all medical and lab appointments.||
2551|170|B|||
2551|171|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2551|172|D|next dose at the regular time. Do not double the dose to catch||
2551|173|D|up.||
2551|174|B|||
2551|175|R|STORAGE:  Store at room temperature away from light and moisture.||
2551|176|R|Do not store in the bathroom. Keep all medications away from||
2551|177|R|children and pets.||
2551|178|R|   Do not flush medications down the toilet or pour them into a||
2551|179|R|drain unless instructed to do so. Properly discard this product||
2551|180|R|when it is expired or no longer needed. Consult your pharmacist||
2551|181|R|or local waste disposal company.||
2551|182|B|||
2551|183|A|Information last revised March 2025.||
2551|184|A|Copyright(c) 2025 First Databank, Inc.||
2551|185|B|||
2552|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2552|002|Z|does NOT have all possible information about this product. This||
2552|003|Z|information does not assure that this product is safe, effective,||
2552|004|Z|or appropriate for you. This information is not individual||
2552|005|Z|medical advice and does not substitute for the advice of your||
2552|006|Z|health care professional. Always ask your health care||
2552|007|Z|professional for complete information about this product and your||
2552|008|Z|specific health needs.||
2552|009|B|||
2552|010|T|CLINDAMYCIN/ADAPALENE/BENZOYL PEROXIDE GEL - TOPICAL||
2552|011|F|(KLIN-da-MYE-sin/a-DAP-a-leen/BEN-zoh-il per-OX-ide)||
2552|012|B|||
2552|013|C|COMMON BRAND NAME(S): Cabtreo||
2552|014|B|||
2552|015|U|USES:  This combination medication is used to treat a certain||
2552|016|U|type of acne (acne vulgaris). It may decrease the number and||
2552|017|U|severity of acne pimples and promote quick healing of pimples||
2552|018|U|that do develop.||
2552|019|U|   Clindamycin is an antibiotic that stops the growth of||
2552|020|U|acne-causing bacteria. Benzoyl peroxide can also stop the growth||
2552|021|U|of acne-causing bacteria and also works by causing the skin to||
2552|022|U|dry and peel. Adapalene belongs to a class of medications called||
2552|023|U|retinoids. Adapalene works by affecting the growth of cells and||
2552|024|U|decreasing swelling and inflammation.||
2552|025|B|||
2552|026|H|HOW TO USE:  Read the Patient Information Leaflet and||
2552|027|H|Instructions for Use if available from your pharmacist before you||
2552|028|H|start using this product and each time you get a refill. If you||
2552|029|H|have any questions, ask your doctor or pharmacist.||
2552|030|H|   Wash and dry your hands before applying the medication. Gently||
2552|031|H|clean the affected skin with a mild or soapless cleanser and pat||
2552|032|H|dry. Apply a thin film of the medication to the affected area and||
2552|033|H|gently rub in as directed by your doctor, usually once daily.||
2552|034|H|Wash your hands after each use.||
2552|035|H|   This medication is for use on the skin only. Avoid using this||
2552|036|H|medication around your eyes, nose folds, inside your nose or||
2552|037|H|mouth, or on any areas of broken skin unless directed by your||
2552|038|H|doctor. If this medication gets into your eyes, flush with large||
2552|039|H|amounts of water. Call your doctor if eye irritation develops.||
2552|040|H|   Benzoyl peroxide may bleach hair or fabrics. Use this product||
2552|041|H|carefully, and avoid contact with hair, clothing, and||
2552|042|H|furnishings.||
2552|043|H|   Use this medication regularly to get the most benefit from it.||
2552|044|H|To help you remember, use it at the same time each day. Do not||
2552|045|H|use a larger amount or use this drug more often than prescribed.||
2552|046|H|Your skin will not improve any faster, and your risk of side||
2552|047|H|effects will increase.||
2552|048|H|   Tell your doctor if your condition does not get better or if||
2552|049|H|it gets worse.||
2552|050|H|   Since this drug can be absorbed through the skin and may harm||
2552|051|H|an unborn baby, women who are pregnant or who may become pregnant||
2552|052|H|should not handle this medication.||
2552|053|B|||
2552|054|S|SIDE EFFECTS:  Skin redness, dryness, peeling, mild||
2552|055|S|burning/stinging, swelling, or worsening of acne may occur during||
2552|056|S|the first 4 weeks of using this product. These effects usually||
2552|057|S|get better as you keep using it. If any of these effects last or||
2552|058|S|get worse, tell your doctor or pharmacist promptly. Your doctor||
2552|059|S|may want you to use a moisturizer, use the product less often, or||
2552|060|S|have you stop using it.||
2552|061|S|   Remember that this medication has been prescribed because your||
2552|062|S|doctor has judged that the benefit to you is greater than the||
2552|063|S|risk of side effects. Many people using this medication do not||
2552|064|S|have serious side effects.||
2552|065|S|   This medication may be absorbed into your bloodstream and very||
2552|066|S|rarely cause a severe intestinal condition due to a bacteria||
2552|067|S|called C. difficile. This condition may occur during treatment or||
2552|068|S|weeks to months after treatment has stopped. Tell your doctor||
2552|069|S|right away if you develop: diarrhea that doesn't stop, abdominal||
2552|070|S|or stomach pain/cramping, blood/mucus in your stool.||
2552|071|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2552|072|S|products because they may make symptoms worse.||
2552|073|S|   A very serious allergic reaction to this drug is rare.||
2552|074|S|However, get medical help right away if you notice any symptoms||
2552|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2552|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2552|077|S|breathing.||
2552|078|S|   This is not a complete list of possible side effects. If you||
2552|079|S|notice other effects not listed above, contact your doctor or||
2552|080|S|pharmacist.||
2552|081|S|   In the US -||
2552|082|S|   Call your doctor for medical advice about side effects. You||
2552|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2552|084|S|www.fda.gov/medwatch.||
2552|085|S|   In Canada - Call your doctor for medical advice about side||
2552|086|S|effects. You may report side effects to Health Canada at||
2552|087|S|1-866-234-2345.||
2552|088|B|||
2552|089|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2552|090|P|pharmacist if you are allergic to adapalene; or to benzoyl||
2552|091|P|peroxide; or to clindamycin; or to lincomycin; or to vitamin||
2552|092|P|A-related drugs (other retinoids such as isotretinoin); or if you||
2552|093|P|have any other allergies. This product may contain inactive||
2552|094|P|ingredients, which can cause allergic reactions or other||
2552|095|P|problems. Talk to your pharmacist for more details.||
2552|096|P|   Before using this medication, tell your doctor or pharmacist||
2552|097|P|your medical history, especially of: eczema, certain intestinal||
2552|098|P|problems (such as regional enteritis, ulcerative colitis, Crohn's||
2552|099|P|disease, severe diarrhea with past antibiotic use).||
2552|100|P|   This medication may make you more sensitive to the sun. Limit||
2552|101|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2552|102|P|sunscreen and wear protective clothing when outdoors. Tell your||
2552|103|P|doctor right away if you get sunburned or have skin||
2552|104|P|blisters/redness. Wait until your skin has completely recovered||
2552|105|P|from a sunburn before using this product. Weather extremes such||
2552|106|P|as wind or cold may also be irritating to the skin.||
2552|107|P|   Avoid electrolysis, waxing, and chemical depilatories for hair||
2552|108|P|removal on the treated areas while using this product.||
2552|109|P|   Since this drug can be absorbed through the skin and may harm||
2552|110|P|an unborn baby, women who are pregnant or who may become pregnant||
2552|111|P|should not handle this medication.||
2552|112|P|   Tell your doctor if you are pregnant or plan to become||
2552|113|P|pregnant. You should not become pregnant while using this||
2552|114|P|medication. Adapalene may harm an unborn baby. If you become||
2552|115|P|pregnant, talk to your doctor right away about the risks and||
2552|116|P|benefits of this medication.||
2552|117|P|   It is unknown if this drug passes into breast milk when used||
2552|118|P|on the skin. Consult your doctor before breastfeeding.||
2552|119|B|||
2552|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2552|121|I|medications work or increase your risk for serious side effects.||
2552|122|I|This document does not contain all possible drug interactions.||
2552|123|I|Keep a list of all the products you use (including||
2552|124|I|prescription/nonprescription drugs and herbal products) and share||
2552|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
2552|126|I|the dosage of any medicines without your doctor's approval.||
2552|127|I|   Some products that may interact with this drug are: other acne||
2552|128|I|skin treatments (such as tretinoin, dapsone).||
2552|129|I|   Avoid using other skin products that are harsh, irritating, or||
2552|130|I|drying on the treated area. These products include hair perming||
2552|131|I|solutions, alcohol/lime/menthol-containing products (such as||
2552|132|I|astringents, toners, shaving lotion), medicated or abrasive soaps||
2552|133|I|or cleansers, soaps and cosmetics with a strong drying effect||
2552|134|I|(such as alpha hydroxy acids, glycolic acid), and products||
2552|135|I|containing sulfur, resorcinol, salicylic acid.||
2552|136|I|   If you have recently used products containing sulfur,||
2552|137|I|resorcinol or salicylic acid, use this product with caution. Wait||
2552|138|I|until the effects of such products on the skin have decreased||
2552|139|I|before using this product.||
2552|140|B|||
2552|141|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2552|142|O|has overdosed and has serious symptoms such as passing out or||
2552|143|O|trouble breathing, call 911. Otherwise, call a poison control||
2552|144|O|center right away. US residents can call 1-800-222-1222. Canada||
2552|145|O|residents can call 1-844-764-7669.||
2552|146|B|||
2552|147|N|NOTES:  Do not share this medication with others.||
2552|148|B|||
2552|149|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
2552|150|D|remember. If it is near the time of the next dose, skip the||
2552|151|D|missed dose. Use your next dose at the regular time. Do not||
2552|152|D|double the dose to catch up.||
2552|153|B|||
2552|154|R|STORAGE:  Store the container upright at room temperature. Do not||
2552|155|R|freeze. Keep away from heat. Discard any unused medication by the||
2552|156|R|expiration date provided by your pharmacist. Keep all medications||
2552|157|R|away from children and pets.||
2552|158|R|   Do not flush medications down the toilet or pour them into a||
2552|159|R|drain unless instructed to do so. Properly discard this product||
2552|160|R|when it is expired or no longer needed. Consult your pharmacist||
2552|161|R|or local waste disposal company.||
2552|162|B|||
2552|163|A|Information last revised May 2024.||
2552|164|A|Copyright(c) 2025 First Databank, Inc.||
2552|165|B|||
2553|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2553|002|Z|does NOT have all possible information about this product. This||
2553|003|Z|information does not assure that this product is safe, effective,||
2553|004|Z|or appropriate for you. This information is not individual||
2553|005|Z|medical advice and does not substitute for the advice of your||
2553|006|Z|health care professional. Always ask your health care||
2553|007|Z|professional for complete information about this product and your||
2553|008|Z|specific health needs.||
2553|009|B|||
2553|010|T|PEGUNIGALSIDASE ALFA - INJECTION||
2553|011|F|(peg-UE-ni-GAL-si-dase AL-fa)||
2553|012|B|||
2553|013|C|COMMON BRAND NAME(S): Elfabrio||
2553|014|B|||
2553|015|W|WARNING:  Pegunigalsidase alfa may cause very serious (sometimes||
2553|016|W|fatal) allergic reactions that may happen during or after the||
2553|017|W|infusion. A health care professional will monitor you closely||
2553|018|W|during and after your infusion. Get medical help right away if||
2553|019|W|you notice any symptoms of a serious allergic reaction, such as||
2553|020|W|rash, itching/swelling (especially of the face/tongue/throat),||
2553|021|W|severe dizziness, trouble breathing, or fast heartbeat. Your||
2553|022|W|doctor may prescribe other medications (such as antihistamines,||
2553|023|W|corticosteroids) to treat these side effects. Your infusion also||
2553|024|W|may be slowed down or stopped depending on your symptoms.||
2553|025|B|||
2553|026|U|USES:  This medication is used to treat a certain inherited||
2553|027|U|disorder (Fabry disease) that causes buildup of a certain fat||
2553|028|U|substance (Gb3) in some parts of your body. If this condition||
2553|029|U|gets worse, it can lead to kidney disease, heart attack, or||
2553|030|U|stroke. Pegunigalsidase alfa works by replacing an enzyme that||
2553|031|U|your body lacks, which helps break down the fat substance Gb3 in||
2553|032|U|your body. This can help to lessen the buildup of Gb3 in the||
2553|033|U|kidneys and blood.||
2553|034|B|||
2553|035|H|HOW TO USE:  This medication is given by slow injection into a||
2553|036|H|vein as directed by your doctor, usually every 2 weeks. The||
2553|037|H|injection is given by a health care professional. The dosage is||
2553|038|H|based on your medical condition, weight, and response to||
2553|039|H|treatment.||
2553|040|H|   Infusion reactions may happen during the infusion of this drug||
2553|041|H|and for up to 24 hours afterward. Your doctor may prescribe other||
2553|042|H|medications (such as acetaminophen, antihistamine,||
2553|043|H|corticosteroids) before each treatment to help prevent these side||
2553|044|H|effects. Tell your doctor right away if you have any symptoms of||
2553|045|H|infusion reactions such as chills, flushing, shaking, cold||
2553|046|H|symptoms (such as sneezing, runny/stuffy nose), nausea, vomiting,||
2553|047|H|diarrhea, dizziness, numb/tingling skin, shooting/stabbing pain,||
2553|048|H|muscle pain, shortness of breath, slow heartbeat, headache, or||
2553|049|H|chest/abdominal pain. Your doctor may give you other medications||
2553|050|H|to help with these side effects or may slow down or stop your||
2553|051|H|treatment for some time.||
2553|052|H|   If you are using this medication at home, learn all||
2553|053|H|preparation and usage instructions in the product package and||
2553|054|H|from your health care professional. If any of the information is||
2553|055|H|unclear, consult your doctor or pharmacist. Remove this||
2553|056|H|medication from the refrigerator and allow the medication and||
2553|057|H|mixing solution to warm to room temperature before mixing. Do not||
2553|058|H|shake the mixed drug. Doing so can make it work less well.||
2553|059|H|   Use this medication regularly to get the most benefit from it.||
2553|060|H|To help you remember, mark your calendar with a reminder.||
2553|061|H|   Tell your doctor if your condition does not get better or if||
2553|062|H|it gets worse.||
2553|063|B|||
2553|064|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2553|065|S|   Tiredness or back pain may occur. If either of these effects||
2553|066|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
2553|067|S|   Remember that this medication has been prescribed because your||
2553|068|S|doctor has judged that the benefit to you is greater than the||
2553|069|S|risk of side effects. Many people using this medication do not||
2553|070|S|have serious side effects.||
2553|071|S|   Tell your doctor right away if you have any serious side||
2553|072|S|effects, including: pain/redness/swelling at injection site.||
2553|073|S|   This is not a complete list of possible side effects. If you||
2553|074|S|notice other effects not listed above, contact your doctor or||
2553|075|S|pharmacist.||
2553|076|S|   In the US -||
2553|077|S|   Call your doctor for medical advice about side effects. You||
2553|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2553|079|S|www.fda.gov/medwatch.||
2553|080|S|   In Canada - Call your doctor for medical advice about side||
2553|081|S|effects. You may report side effects to Health Canada at||
2553|082|S|1-866-234-2345.||
2553|083|B|||
2553|084|P|PRECAUTIONS:  Before using pegunigalsidase alfa, tell your doctor||
2553|085|P|or pharmacist if you are allergic to it; or if you have any other||
2553|086|P|allergies. This product may contain inactive ingredients, which||
2553|087|P|can cause allergic reactions or other problems. Talk to your||
2553|088|P|pharmacist for more details.||
2553|089|P|   Before using this medication, tell your doctor or pharmacist||
2553|090|P|your medical history, especially of: previous enzyme replacement||
2553|091|P|therapy.||
2553|092|P|   Before having surgery, tell your doctor or dentist about all||
2553|093|P|the products you use (including prescription drugs,||
2553|094|P|nonprescription drugs, and herbal products).||
2553|095|P|   During pregnancy, this medication should be used only when||
2553|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
2553|097|P|   It is unknown if this medication passes into breast milk.||
2553|098|P|Consult your doctor before breastfeeding.||
2553|099|B|||
2553|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2553|101|I|medications work or increase your risk for serious side effects.||
2553|102|I|This document does not contain all possible drug interactions.||
2553|103|I|Keep a list of all the products you use (including||
2553|104|I|prescription/nonprescription drugs and herbal products) and share||
2553|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
2553|106|I|the dosage of any medicines without your doctor's approval.||
2553|107|B|||
2553|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2553|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2553|110|O|poison control center right away. US residents can call||
2553|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2553|112|B|||
2553|113|N|NOTES:  Lab and/or medical tests (such as kidney function) may be||
2553|114|N|done while you are using this medication. Keep all medical and||
2553|115|N|lab appointments.||
2553|116|B|||
2553|117|D|MISSED DOSE:  It is important to get each dose of this medication||
2553|118|D|as scheduled. Do not use an extra dose to make up for a missed||
2553|119|D|dose. If you miss a dose, ask your doctor or pharmacist right||
2553|120|D|away for a new dosing schedule.||
2553|121|B|||
2553|122|R|STORAGE:  Store in the refrigerator. Do not freeze. After||
2553|123|R|removing from the refrigerator, use the mixed drug within 8||
2553|124|R|hours. Discard any unused portion. Keep all medications away from||
2553|125|R|children and pets.||
2553|126|R|   Do not flush medications down the toilet or pour them into a||
2553|127|R|drain unless instructed to do so. Properly discard this product||
2553|128|R|when it is expired or no longer needed. Consult your pharmacist||
2553|129|R|or local waste disposal company.||
2553|130|B|||
2553|131|A|Information last revised October 2024.||
2553|132|A|Copyright(c) 2025 First Databank, Inc.||
2553|133|B|||
2554|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2554|002|Z|does NOT have all possible information about this product. This||
2554|003|Z|information does not assure that this product is safe, effective,||
2554|004|Z|or appropriate for you. This information is not individual||
2554|005|Z|medical advice and does not substitute for the advice of your||
2554|006|Z|health care professional. Always ask your health care||
2554|007|Z|professional for complete information about this product and your||
2554|008|Z|specific health needs.||
2554|009|B|||
2554|010|T|CAPIVASERTIB - ORAL||
2554|011|F|(kap-EYE-va-SER-tib)||
2554|012|B|||
2554|013|C|COMMON BRAND NAME(S): Truqap||
2554|014|B|||
2554|015|U|USES:  Capivasertib is used with another medication (fulvestrant)||
2554|016|U|to treat breast cancer. Capivasertib belongs to a class of drugs||
2554|017|U|known as kinase inhibitors. It works by slowing or stopping the||
2554|018|U|growth of cancer cells.||
2554|019|B|||
2554|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2554|021|H|from your pharmacist before you start taking capivasertib and||
2554|022|H|each time you get a refill. If you have any questions, ask your||
2554|023|H|doctor or pharmacist.||
2554|024|H|   Take this medication by mouth with or without food as directed||
2554|025|H|by your doctor, usually twice daily (about 12 hours apart) for 4||
2554|026|H|days, followed by 3 days off treatment. Keep taking the||
2554|027|H|medication in this way for as long as directed by your doctor.||
2554|028|H|Swallow the medication whole. Do not crush, chew, or split the||
2554|029|H|tablets. Do not take the tablet if it is crushed or broken.||
2554|030|H|   The dosage is based on your medical condition, response to||
2554|031|H|treatment, lab tests, and other medications you may be taking. Be||
2554|032|H|sure to tell your doctor and pharmacist about all the products||
2554|033|H|you use (including prescription drugs, nonprescription drugs, and||
2554|034|H|herbal products).||
2554|035|H|   Use this medication regularly to get the most benefit from it.||
2554|036|H|To help you remember, take it at the same times each day on the||
2554|037|H|days you take the medication.||
2554|038|H|   Do not increase your dose or use this drug more often or for||
2554|039|H|longer than prescribed. Your condition will not improve any||
2554|040|H|faster, and your risk of serious side effects will increase.||
2554|041|H|   If you vomit after taking a dose, do not take another dose at||
2554|042|H|that time. Take your next dose at the regular time.||
2554|043|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2554|044|H|using this medication unless your doctor or pharmacist says you||
2554|045|H|may do so safely. Grapefruit can increase the chance of side||
2554|046|H|effects with this medicine. Ask your doctor or pharmacist for||
2554|047|H|more details.||
2554|048|H|   Since this drug can be absorbed through the skin and lungs and||
2554|049|H|may harm an unborn baby, women who are pregnant or who may become||
2554|050|H|pregnant should not handle this medication or breathe the dust||
2554|051|H|from the tablets.||
2554|052|B|||
2554|053|S|SIDE EFFECTS:  Nausea, vomiting, tiredness, mouth sores/pain,||
2554|054|S|loss of appetite, or stomach/abdominal pain may occur. If any of||
2554|055|S|these effects last or get worse, tell your doctor or pharmacist||
2554|056|S|promptly.||
2554|057|S|   People using this medication may have serious side effects.||
2554|058|S|However, you have been prescribed this drug because your doctor||
2554|059|S|has judged that the benefit to you is greater than the risk of||
2554|060|S|side effects. Careful monitoring by your doctor may decrease your||
2554|061|S|risk.||
2554|062|S|   Diarrhea is a common side effect. Drink plenty of fluids as||
2554|063|S|directed by your doctor to lower your risk of dehydration. Your||
2554|064|S|doctor should prescribe anti-diarrhea medication (such as||
2554|065|S|loperamide) for you to take in case you get diarrhea. Tell your||
2554|066|S|doctor right away if you develop diarrhea that is severe or||
2554|067|S|doesn't stop, or signs of dehydration (such as unusual decreased||
2554|068|S|urination, unusual dry mouth/thirst, fast heartbeat,||
2554|069|S|dizziness/lightheadedness).||
2554|070|S|   This medication may make your blood sugar rise, which can||
2554|071|S|cause or worsen diabetes. Tell your doctor right away if you have||
2554|072|S|symptoms of high blood sugar, such as increased thirst/urination.||
2554|073|S|If you already have diabetes, check your blood sugar regularly as||
2554|074|S|directed and share the results with your doctor. Your doctor may||
2554|075|S|need to adjust your diabetes medication, exercise program, or||
2554|076|S|diet.||
2554|077|S|   Tell your doctor right away if you have any serious side||
2554|078|S|effects, including: signs of kidney problems (such as change in||
2554|079|S|the amount of urine), unusual tiredness, confusion.||
2554|080|S|   A very serious allergic reaction to this drug is rare.||
2554|081|S|However, get medical help right away if you notice any symptoms||
2554|082|S|of a serious allergic reaction, including: fever, swollen lymph||
2554|083|S|nodes, rash, itching/swelling (especially of the||
2554|084|S|face/tongue/throat), severe dizziness, trouble breathing.||
2554|085|S|   Capivasertib can commonly cause a mild rash that is usually||
2554|086|S|not serious. However, you may not be able to tell it apart from a||
2554|087|S|rare rash that could be a sign of a severe allergic reaction. Get||
2554|088|S|medical help right away if you develop any rash.||
2554|089|S|   This is not a complete list of possible side effects. If you||
2554|090|S|notice other effects not listed above, contact your doctor or||
2554|091|S|pharmacist.||
2554|092|S|   In the US -||
2554|093|S|   Call your doctor for medical advice about side effects. You||
2554|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2554|095|S|www.fda.gov/medwatch.||
2554|096|S|   In Canada - Call your doctor for medical advice about side||
2554|097|S|effects. You may report side effects to Health Canada at||
2554|098|S|1-866-234-2345.||
2554|099|B|||
2554|100|P|PRECAUTIONS:  Before taking capivasertib, tell your doctor or||
2554|101|P|pharmacist if you are allergic to it; or if you have any other||
2554|102|P|allergies. This product may contain inactive ingredients, which||
2554|103|P|can cause allergic reactions or other problems. Talk to your||
2554|104|P|pharmacist for more details.||
2554|105|P|   Before using this medication, tell your doctor or pharmacist||
2554|106|P|your medical history, especially of: liver disease, diabetes.||
2554|107|P|   Before having surgery, tell your doctor or dentist about all||
2554|108|P|the products you use (including prescription drugs,||
2554|109|P|nonprescription drugs, and herbal products).||
2554|110|P|   Older adults may be more sensitive to the side effects of this||
2554|111|P|drug.||
2554|112|P|   Since this drug can be absorbed through the skin and lungs and||
2554|113|P|may harm an unborn baby, women who are pregnant or who may become||
2554|114|P|pregnant should not handle this medication or breathe the dust||
2554|115|P|from the tablets.||
2554|116|P|   Tell your doctor if you are pregnant or plan to become||
2554|117|P|pregnant. You should not become pregnant while using||
2554|118|P|capivasertib. Capivasertib may harm an unborn baby. Your doctor||
2554|119|P|should order a pregnancy test before you start this medication.||
2554|120|P|Men and women using this medication should ask about reliable||
2554|121|P|forms of birth control during treatment and for some time after||
2554|122|P|the last dose. If you or your partner becomes pregnant, talk to||
2554|123|P|your doctor right away about the risks and benefits of this||
2554|124|P|medication.||
2554|125|P|   It is unknown if this medication passes into breast milk.||
2554|126|P|Because of the possible risk to the infant, breastfeeding is not||
2554|127|P|recommended while using this medication. Consult your doctor||
2554|128|P|before breastfeeding.||
2554|129|B|||
2554|130|I|DRUG INTERACTIONS:  See also How to Use section.||
2554|131|I|   Drug interactions may change how your medications work or||
2554|132|I|increase your risk for serious side effects. This document does||
2554|133|I|not contain all possible drug interactions. Keep a list of all||
2554|134|I|the products you use (including prescription/nonprescription||
2554|135|I|drugs and herbal products) and share it with your doctor and||
2554|136|I|pharmacist. Do not start, stop, or change the dosage of any||
2554|137|I|medicines without your doctor's approval.||
2554|138|I|   Other medications can affect the removal of capivasertib from||
2554|139|I|your body, which may affect how capivasertib works. Examples||
2554|140|I|include efavirenz, rifamycins (such as rifabutin, rifampin),||
2554|141|I|among others.||
2554|142|B|||
2554|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2554|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2554|145|O|poison control center right away. US residents can call||
2554|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2554|147|B|||
2554|148|N|NOTES:  Do not share this medication with others.||
2554|149|N|   Lab and/or medical tests (such as blood glucose, HbA1C,||
2554|150|N|complete blood count, blood mineral levels, kidney function)||
2554|151|N|should be done before you start taking this medication and while||
2554|152|N|you are taking it. Keep all medical and lab appointments. Consult||
2554|153|N|your doctor for more details.||
2554|154|B|||
2554|155|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2554|156|D|remember. If it is more than 4 hours after the missed dose, skip||
2554|157|D|the missed dose. Take your next dose at the regular time. Do not||
2554|158|D|double the dose to catch up.||
2554|159|B|||
2554|160|R|STORAGE:  Store in the original package at room temperature away||
2554|161|R|from light and moisture. Do not store in the bathroom. Keep all||
2554|162|R|medications away from children and pets.||
2554|163|R|   Do not flush medications down the toilet or pour them into a||
2554|164|R|drain unless instructed to do so. Properly discard this product||
2554|165|R|when it is expired or no longer needed. Consult your pharmacist||
2554|166|R|or local waste disposal company.||
2554|167|B|||
2554|168|A|Information last revised February 2025.||
2554|169|A|Copyright(c) 2025 First Databank, Inc.||
2554|170|B|||
2555|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2555|002|Z|does NOT have all possible information about this product. This||
2555|003|Z|information does not assure that this product is safe, effective,||
2555|004|Z|or appropriate for you. This information is not individual||
2555|005|Z|medical advice and does not substitute for the advice of your||
2555|006|Z|health care professional. Always ask your health care||
2555|007|Z|professional for complete information about this product and your||
2555|008|Z|specific health needs.||
2555|009|B|||
2555|010|T|TORIPALIMAB - INJECTION||
2555|011|B|||
2555|012|C|COMMON BRAND NAME(S): Loqtorzi||
2555|013|B|||
2555|014|U|USES:  Toripalimab is used to treat a certain type of head and||
2555|015|U|neck cancer (nasopharyngeal carcinoma). It works by changing the||
2555|016|U|action of your own immune system, directing it to attack cancer||
2555|017|U|cells. Toripalimab belongs to a class of drugs known as||
2555|018|U|monoclonal antibodies.||
2555|019|B|||
2555|020|H|HOW TO USE:  Read the Medication Guide provided by your||
2555|021|H|pharmacist before you start receiving toripalimab and each time||
2555|022|H|you get a treatment. If you have any questions, ask your doctor||
2555|023|H|or pharmacist.||
2555|024|H|   This medication is given by a health care professional. It is||
2555|025|H|injected slowly into a vein over 30 or 60 minutes. It is given as||
2555|026|H|directed by your doctor, usually once every 2 or 3 weeks.||
2555|027|H|   The dosage is based on your medical condition, weight, and||
2555|028|H|response to treatment.||
2555|029|H|   Infusion reactions may happen during the infusion of this||
2555|030|H|drug. Tell your doctor right away if you have symptoms of||
2555|031|H|infusion reactions such as shaking, fever, chills, flushing,||
2555|032|H|shortness of breath, dizziness, or itching. Your doctor may give||
2555|033|H|you another medication (a corticosteroid such as prednisone) to||
2555|034|H|help with these side effects or may stop your treatment for some||
2555|035|H|time.||
2555|036|H|   Use this medication regularly to get the most benefit from it.||
2555|037|H|To help you remember, mark your calendar with a reminder.||
2555|038|B|||
2555|039|S|SIDE EFFECTS:  See also How to Use section.||
2555|040|S|   Tiredness may occur. If this effect lasts or gets worse, tell||
2555|041|S|your doctor or pharmacist promptly.||
2555|042|S|   People using this medication may have serious side effects.||
2555|043|S|However, you have been prescribed this drug because your doctor||
2555|044|S|has judged that the benefit to you is greater than the risk of||
2555|045|S|side effects. Careful monitoring by your doctor may decrease your||
2555|046|S|risk.||
2555|047|S|   Tell your doctor right away if you have any serious side||
2555|048|S|effects, including: new/worsening cough, diarrhea with||
2555|049|S|blood/mucus, severe stomach/abdominal pain, mouth/throat sores,||
2555|050|S|symptoms of liver disease (such as nausea/vomiting that doesn't||
2555|051|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
2555|052|S|eyes/skin, dark urine), signs of kidney problems (such as change||
2555|053|S|in the amount of urine, pink/bloody urine), easy||
2555|054|S|bruising/bleeding, swelling hands/ankles/feet, unusual weakness,||
2555|055|S|joint stiffness/pain, muscle||
2555|056|S|weakness/tenderness/pain/spasms/cramps, numbness/tingling of||
2555|057|S|arms/legs, loss of coordination, eye redness/pain/sensitivity to||
2555|058|S|light, vision changes, headache that is unusual or doesn't go||
2555|059|S|away, seizures.||
2555|060|S|   Toripalimab may cause hormone gland problems (such as thyroid,||
2555|061|S|pituitary, adrenal, pancreas). Your body could make too much or||
2555|062|S|too little hormone. Tell your doctor right away if you have any||
2555|063|S|symptoms such as: cold or heat intolerance, unexplained weight||
2555|064|S|loss/gain, increased thirst/urination, mood or behavior changes||
2555|065|S|(such as decreased sex drive, irritability, forgetfulness),||
2555|066|S|slow/fast/pounding/irregular heartbeat, unusual tiredness,||
2555|067|S|constipation.||
2555|068|S|   Get medical help right away if you have any very serious side||
2555|069|S|effects, including: chest pain, shortness of breath.||
2555|070|S|   Toripalimab can commonly cause itching or a rash that is||
2555|071|S|usually not serious. However, you may not be able to tell it||
2555|072|S|apart from a rare rash that could be a sign of a severe reaction.||
2555|073|S|Get medical help right away if you develop any rash or itching.||
2555|074|S|   A very serious allergic reaction to this drug is rare.||
2555|075|S|However, get medical help right away if you notice any symptoms||
2555|076|S|of a serious allergic reaction, including: fever, swollen lymph||
2555|077|S|nodes, rash, itching/swelling (especially of the||
2555|078|S|face/tongue/throat), severe dizziness, trouble breathing.||
2555|079|S|   This is not a complete list of possible side effects. If you||
2555|080|S|notice other effects not listed above, contact your doctor or||
2555|081|S|pharmacist.||
2555|082|S|   In the US -||
2555|083|S|   Call your doctor for medical advice about side effects. You||
2555|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2555|085|S|www.fda.gov/medwatch.||
2555|086|S|   In Canada - Call your doctor for medical advice about side||
2555|087|S|effects. You may report side effects to Health Canada at||
2555|088|S|1-866-234-2345.||
2555|089|B|||
2555|090|P|PRECAUTIONS:  Before using toripalimab, tell your doctor or||
2555|091|P|pharmacist if you are allergic to it; or if you have any other||
2555|092|P|allergies. This product may contain inactive ingredients, which||
2555|093|P|can cause allergic reactions or other problems. Talk to your||
2555|094|P|pharmacist for more details.||
2555|095|P|   Before using this medication, tell your doctor or pharmacist||
2555|096|P|your medical history, especially of: organ transplant, radiation||
2555|097|P|treatment, stem cell transplant with donor cells.||
2555|098|P|   Before having surgery, tell your doctor or dentist about all||
2555|099|P|the products you use (including prescription drugs,||
2555|100|P|nonprescription drugs, and herbal products).||
2555|101|P|   Tell your doctor if you are pregnant or plan to become||
2555|102|P|pregnant. You should not become pregnant while using toripalimab.||
2555|103|P|Toripalimab may harm an unborn baby. Your doctor should order a||
2555|104|P|pregnancy test before you start this medication. Ask about||
2555|105|P|reliable forms of birth control while using this medication and||
2555|106|P|for 4 months after the last dose. If you become pregnant, talk to||
2555|107|P|your doctor right away about the risks and benefits of this||
2555|108|P|medication.||
2555|109|P|   It is unknown if this drug passes into breast milk. Because of||
2555|110|P|the possible risk to the infant, breastfeeding is not recommended||
2555|111|P|while using this drug and for 4 months after the last dose.||
2555|112|P|Consult your doctor before breastfeeding.||
2555|113|B|||
2555|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2555|115|I|medications work or increase your risk for serious side effects.||
2555|116|I|This document does not contain all possible drug interactions.||
2555|117|I|Keep a list of all the products you use (including||
2555|118|I|prescription/nonprescription drugs and herbal products) and share||
2555|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
2555|120|I|the dosage of any medicines without your doctor's approval.||
2555|121|B|||
2555|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2555|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2555|124|O|poison control center right away. US residents can call||
2555|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2555|126|B|||
2555|127|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
2555|128|N|function, blood sugar) should be done before you start using this||
2555|129|N|medication and while you are using it. Keep all medical and lab||
2555|130|N|appointments. Consult your doctor for more details.||
2555|131|B|||
2555|132|D|MISSED DOSE:  It is important to get each dose of this medication||
2555|133|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2555|134|D|right away for a new dosing schedule.||
2555|135|B|||
2555|136|R|STORAGE:  Not applicable. This medication is given in a hospital||
2555|137|R|or clinic and will not be stored at home.||
2555|138|B|||
2555|139|A|Information last revised October 2024.||
2555|140|A|Copyright(c) 2025 First Databank, Inc.||
2555|141|B|||
2556|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2556|002|Z|does NOT have all possible information about this product. This||
2556|003|Z|information does not assure that this product is safe, effective,||
2556|004|Z|or appropriate for you. This information is not individual||
2556|005|Z|medical advice and does not substitute for the advice of your||
2556|006|Z|health care professional. Always ask your health care||
2556|007|Z|professional for complete information about this product and your||
2556|008|Z|specific health needs.||
2556|009|B|||
2556|010|T|ADAMTS13, RECOMBINANT - INJECTION||
2556|011|B|||
2556|012|C|COMMON BRAND NAME(S): Adzynma||
2556|013|B|||
2556|014|U|USES:  This medication is used to treat a certain blood disorder||
2556|015|U|(congenital thrombotic thrombocytopenic purpura-cTTP). People||
2556|016|U|with cTTP do not have enough of a certain enzyme (ADAMTS13) in||
2556|017|U|the blood, so blood clots form in small blood vessels throughout||
2556|018|U|the body. These clots can cause serious medical problems if they||
2556|019|U|block vessels and limit or stop blood flow to organs such as the||
2556|020|U|brain, kidneys, and heart. ADAMTS13 works by causing your body to||
2556|021|U|make fewer/smaller blood clots.||
2556|022|B|||
2556|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2556|024|H|from your pharmacist before you start using ADAMTS13 and each||
2556|025|H|time you get a refill. If you have any questions, ask your doctor||
2556|026|H|or pharmacist.||
2556|027|H|   This medication is given by slow injection into a vein by a||
2556|028|H|health care professional. The dosage and treatment schedule are||
2556|029|H|based on your medical condition, weight, and response to||
2556|030|H|treatment.||
2556|031|H|   To get the most benefit from this medication, carefully follow||
2556|032|H|your doctor's treatment schedule. To help you remember, mark your||
2556|033|H|calendar with a reminder.||
2556|034|H|   Tell your doctor if your condition does not get better or if||
2556|035|H|it gets worse.||
2556|036|B|||
2556|037|S|SIDE EFFECTS:  Headache, diarrhea, nausea, vomiting, abdominal||
2556|038|S|pain, dizziness, or cold symptoms (such as stuffy/runny nose,||
2556|039|S|cough) may occur. If any of these effects last or get worse, tell||
2556|040|S|your doctor or pharmacist promptly.||
2556|041|S|   Remember that this medication has been prescribed because your||
2556|042|S|doctor has judged that the benefit to you is greater than the||
2556|043|S|risk of side effects. Many people using this medication do not||
2556|044|S|have serious side effects.||
2556|045|S|   A very serious allergic reaction to this drug is rare.||
2556|046|S|However, get medical help right away if you notice any symptoms||
2556|047|S|of a serious allergic reaction, including: rash, itching/swelling||
2556|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2556|049|S|breathing.||
2556|050|S|   This is not a complete list of possible side effects. If you||
2556|051|S|notice other effects not listed above, contact your doctor or||
2556|052|S|pharmacist.||
2556|053|S|   In the US -||
2556|054|S|   Call your doctor for medical advice about side effects. You||
2556|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2556|056|S|www.fda.gov/medwatch.||
2556|057|S|   In Canada - Call your doctor for medical advice about side||
2556|058|S|effects. You may report side effects to Health Canada at||
2556|059|S|1-866-234-2345.||
2556|060|B|||
2556|061|P|PRECAUTIONS:  Before using ADAMTS13, tell your doctor or||
2556|062|P|pharmacist if you are allergic to it; or if you have any other||
2556|063|P|allergies. This product may contain inactive ingredients, which||
2556|064|P|can cause allergic reactions or other problems. Talk to your||
2556|065|P|pharmacist for more details.||
2556|066|P|   Before using this medication, tell your doctor or pharmacist||
2556|067|P|your medical history.||
2556|068|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2556|069|P|can make you more dizzy. Do not drive, use machinery, or do||
2556|070|P|anything that needs alertness until you can do it safely. Limit||
2556|071|P|alcoholic beverages. Talk to your doctor if you are using||
2556|072|P|marijuana (cannabis).||
2556|073|P|   Before having surgery, tell your doctor or dentist about all||
2556|074|P|the products you use (including prescription drugs,||
2556|075|P|nonprescription drugs, and herbal products).||
2556|076|P|   During pregnancy, this medication should be used only when||
2556|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
2556|078|P|   It is unknown if this medication passes into breast milk.||
2556|079|P|Consult your doctor before breastfeeding.||
2556|080|B|||
2556|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2556|082|I|medications work or increase your risk for serious side effects.||
2556|083|I|This document does not contain all possible drug interactions.||
2556|084|I|Keep a list of all the products you use (including||
2556|085|I|prescription/nonprescription drugs and herbal products) and share||
2556|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
2556|087|I|the dosage of any medicines without your doctor's approval.||
2556|088|B|||
2556|089|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2556|090|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2556|091|O|poison control center right away. US residents can call||
2556|092|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2556|093|B|||
2556|094|N|NOTES:  Keep all medical and lab appointments.||
2556|095|B|||
2556|096|D|MISSED DOSE:  It is important to get each dose of this medication||
2556|097|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2556|098|D|right away for a new dosing schedule.||
2556|099|B|||
2556|100|R|STORAGE:  Not applicable. This medication is given in a hospital||
2556|101|R|or clinic or doctor's office and will not be stored at home.||
2556|102|B|||
2556|103|M|MEDICAL ALERT:  Your condition can cause complications in a||
2556|104|M|medical emergency. For information about enrolling in MedicAlert,||
2556|105|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2556|106|B|||
2556|107|A|Information last revised May 2024.||
2556|108|A|Copyright(c) 2025 First Databank, Inc.||
2556|109|B|||
2557|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2557|002|Z|does NOT have all possible information about this product. This||
2557|003|Z|information does not assure that this product is safe, effective,||
2557|004|Z|or appropriate for you. This information is not individual||
2557|005|Z|medical advice and does not substitute for the advice of your||
2557|006|Z|health care professional. Always ask your health care||
2557|007|Z|professional for complete information about this product and your||
2557|008|Z|specific health needs.||
2557|009|B|||
2557|010|T|NIROGACESTAT - ORAL||
2557|011|F|(NYE-roe-GAY-se-stat)||
2557|012|B|||
2557|013|C|COMMON BRAND NAME(S): Ogsiveo||
2557|014|B|||
2557|015|U|USES:  This medication is used to treat desmoid tumors.||
2557|016|U|Nirogacestat works by slowing or stopping the growth of tumor||
2557|017|U|cells.||
2557|018|B|||
2557|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2557|020|H|from your pharmacist before you start taking nirogacestat and||
2557|021|H|each time you get a refill. If you have any questions, ask your||
2557|022|H|doctor or pharmacist.||
2557|023|H|   Take this medication by mouth with or without food as directed||
2557|024|H|by your doctor, usually twice daily. Swallow the medication||
2557|025|H|whole. Do not break, crush, or chew the tablets. The dosage is||
2557|026|H|based on your medical condition and response to treatment.||
2557|027|H|   If you vomit after taking a dose, do not take another dose at||
2557|028|H|that time. Take your next dose at the regular time.||
2557|029|H|   Antacids can decrease the absorption of nirogacestat. If you||
2557|030|H|are taking an antacid, take nirogacestat 2 hours before or 2||
2557|031|H|hours after taking antacids.||
2557|032|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2557|033|H|using this medication unless your doctor or pharmacist says you||
2557|034|H|may do so safely. Also avoid eating Seville oranges (often found||
2557|035|H|in marmalade) and star fruit. Grapefruit, Seville oranges, and||
2557|036|H|star fruit can increase the chance of side effects with this||
2557|037|H|medicine. Ask your doctor or pharmacist for more details.||
2557|038|H|   Use this medication regularly to get the most benefit from it.||
2557|039|H|To help you remember, take it at the same times each day.||
2557|040|H|   Do not increase your dose or use this drug more often or for||
2557|041|H|longer than prescribed. Your condition will not improve any||
2557|042|H|faster, and your risk of serious side effects will increase.||
2557|043|H|   Since this drug can be absorbed through the skin and lungs and||
2557|044|H|may harm an unborn baby, women who are pregnant or who may become||
2557|045|H|pregnant should not handle this medication or breathe the dust||
2557|046|H|from the tablets.||
2557|047|B|||
2557|048|S|SIDE EFFECTS:  Nausea, headache, tiredness, hair loss, cold||
2557|049|S|symptoms (stuffy/runny nose, cough), abdominal pain, or diarrhea||
2557|050|S|may occur. Your doctor may prescribe other medications to control||
2557|051|S|the diarrhea, or may stop/lower the dose of nirogacestat. If any||
2557|052|S|of these effects last or get worse, tell your doctor or||
2557|053|S|pharmacist promptly.||
2557|054|S|   Pain or sores in the mouth and throat may occur. Brush your||
2557|055|S|teeth carefully/gently, avoid using mouthwash that contains||
2557|056|S|alcohol, and rinse your mouth often with cool water mixed with||
2557|057|S|baking soda or salt. It may also be best to eat soft, moist||
2557|058|S|foods.||
2557|059|S|   People using this medication may have serious side effects.||
2557|060|S|However, you have been prescribed this drug because your doctor||
2557|061|S|has judged that the benefit to you is greater than the risk of||
2557|062|S|side effects. Careful monitoring by your doctor may decrease your||
2557|063|S|risk.||
2557|064|S|   This medication may cause mineral imbalance (low||
2557|065|S|potassium/phosphate). Your doctor may prescribe supplement(s) to||
2557|066|S|replace these minerals. Tell your doctor right away if you have||
2557|067|S|any symptoms of low potassium or phosphate blood levels,||
2557|068|S|including muscle cramps or irregular heartbeat.||
2557|069|S|   Tell your doctor right away if you have any serious side||
2557|070|S|effects, including: irregular periods, hot flashes, night sweats,||
2557|071|S|shortness of breath.||
2557|072|S|   This medication may rarely cause new skin cancers. Your doctor||
2557|073|S|should do regular skin exams before and during treatment. Tell||
2557|074|S|your doctor right away if you notice any unusual skin changes||
2557|075|S|(such as change in appearance/size of moles).||
2557|076|S|   Nirogacestat can commonly cause a mild rash that is usually||
2557|077|S|not serious. However, you may not be able to tell it apart from a||
2557|078|S|rare rash that could be a sign of a severe allergic reaction. Get||
2557|079|S|medical help right away if you develop any rash.||
2557|080|S|   A very serious allergic reaction to this drug is rare.||
2557|081|S|However, get medical help right away if you notice any symptoms||
2557|082|S|of a serious allergic reaction, including: rash, itching/swelling||
2557|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2557|084|S|breathing.||
2557|085|S|   This is not a complete list of possible side effects. If you||
2557|086|S|notice other effects not listed above, contact your doctor or||
2557|087|S|pharmacist.||
2557|088|S|   In the US -||
2557|089|S|   Call your doctor for medical advice about side effects. You||
2557|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2557|091|S|www.fda.gov/medwatch.||
2557|092|S|   In Canada - Call your doctor for medical advice about side||
2557|093|S|effects. You may report side effects to Health Canada at||
2557|094|S|1-866-234-2345.||
2557|095|B|||
2557|096|P|PRECAUTIONS:  Before taking nirogacestat, tell your doctor or||
2557|097|P|pharmacist if you are allergic to it; or if you have any other||
2557|098|P|allergies. This product may contain inactive ingredients, which||
2557|099|P|can cause allergic reactions or other problems. Talk to your||
2557|100|P|pharmacist for more details.||
2557|101|P|   Before using this medication, tell your doctor or pharmacist||
2557|102|P|your medical history, especially of: liver disease, low blood||
2557|103|P|mineral levels (potassium, phosphate).||
2557|104|P|   Before having surgery, tell your doctor or dentist about all||
2557|105|P|the products you use (including prescription drugs,||
2557|106|P|nonprescription drugs, and herbal products).||
2557|107|P|   Since this drug can be absorbed through the skin and lungs and||
2557|108|P|may harm an unborn baby, women who are pregnant or who may become||
2557|109|P|pregnant should not handle this medication or breathe the dust||
2557|110|P|from the tablets.||
2557|111|P|   Tell your doctor if you are pregnant or plan to become||
2557|112|P|pregnant. You should not become pregnant while using||
2557|113|P|nirogacestat. Nirogacestat may harm an unborn baby. Your doctor||
2557|114|P|should order a pregnancy test before you start this medication.||
2557|115|P|Men and women using this medication should ask about reliable||
2557|116|P|forms of birth control during treatment and for 1 week after the||
2557|117|P|last dose. If you or your partner becomes pregnant, talk to your||
2557|118|P|doctor right away about the risks and benefits of this||
2557|119|P|medication.||
2557|120|P|   It is unknown if this medication passes into breast milk.||
2557|121|P|Because of the possible risk to the infant, breastfeeding is not||
2557|122|P|recommended while using this medication and for 1 week after the||
2557|123|P|last dose. Consult your doctor before breastfeeding.||
2557|124|B|||
2557|125|I|DRUG INTERACTIONS:  See also How to Use section.||
2557|126|I|   Drug interactions may change how your medications work or||
2557|127|I|increase your risk for serious side effects. This document does||
2557|128|I|not contain all possible drug interactions. Keep a list of all||
2557|129|I|the products you use (including prescription/nonprescription||
2557|130|I|drugs and herbal products) and share it with your doctor and||
2557|131|I|pharmacist. Do not start, stop, or change the dosage of any||
2557|132|I|medicines without your doctor's approval.||
2557|133|I|   Other medications can affect the removal of nirogacestat from||
2557|134|I|your body, which may affect how nirogacestat works. Examples||
2557|135|I|include azole antifungals (such as fluconazole, itraconazole,||
2557|136|I|ketoconazole), efavirenz, macrolide antibiotics (such as||
2557|137|I|clarithromycin, erythromycin), rifampin, among others.||
2557|138|I|   This medication can slow down the removal of other medications||
2557|139|I|from your body, which may affect how they work. Examples of||
2557|140|I|affected drugs include lomitapide, midazolam, among others.||
2557|141|B|||
2557|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2557|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2557|144|O|poison control center right away. US residents can call||
2557|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2557|146|B|||
2557|147|N|NOTES:  Do not share this medication with others.||
2557|148|N|   Lab and/or medical tests (such as liver function, blood||
2557|149|N|mineral levels, skin exams) should be done before you start||
2557|150|N|taking this medication and while you are taking it. Keep all||
2557|151|N|medical and lab appointments. Consult your doctor for more||
2557|152|N|details.||
2557|153|B|||
2557|154|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2557|155|D|next dose at the regular time. Do not double the dose to catch||
2557|156|D|up.||
2557|157|B|||
2557|158|R|STORAGE:  Store at room temperature away from light and moisture.||
2557|159|R|Do not store in the bathroom. Keep all medications away from||
2557|160|R|children and pets.||
2557|161|R|   Do not flush medications down the toilet or pour them into a||
2557|162|R|drain unless instructed to do so. Properly discard this product||
2557|163|R|when it is expired or no longer needed. Consult your pharmacist||
2557|164|R|or local waste disposal company.||
2557|165|B|||
2557|166|A|Information last revised March 2025.||
2557|167|A|Copyright(c) 2025 First Databank, Inc.||
2557|168|B|||
2558|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2558|002|Z|does NOT have all possible information about this product. This||
2558|003|Z|information does not assure that this product is safe, effective,||
2558|004|Z|or appropriate for you. This information is not individual||
2558|005|Z|medical advice and does not substitute for the advice of your||
2558|006|Z|health care professional. Always ask your health care||
2558|007|Z|professional for complete information about this product and your||
2558|008|Z|specific health needs.||
2558|009|B|||
2558|010|T|LOVOTIBEGLOGENE AUTOTEMCEL - INJECTION||
2558|011|B|||
2558|012|C|COMMON BRAND NAME(S): Lyfgenia||
2558|013|B|||
2558|014|W|WARNING:  This product may increase your risk of developing blood||
2558|015|W|cancer. Blood cancer may occur many years after your treatment.||
2558|016|W|Your doctor should do regular blood tests for at least 15 years||
2558|017|W|to monitor for any changes to your blood. Tell your doctor right||
2558|018|W|away if you develop symptoms of blood cancer, such as unusual||
2558|019|W|tiredness, easy bruising/bleeding, or swollen lymph nodes. Talk||
2558|020|W|to your doctor about the risks and benefits of this product.||
2558|021|B|||
2558|022|U|USES:  Lovotibeglogene autotemcel is used to treat sickle cell||
2558|023|U|disease. This disease causes your body to make red blood cells||
2558|024|U|that are stiff and irregularly shaped (sickle- or crescent||
2558|025|U|moon-shaped), which can lead to anemia and painful crises. This||
2558|026|U|type of treatment is known as gene therapy. Your lovotibeglogene||
2558|027|U|autotemcel is made from your own blood stem cells and is given||
2558|028|U|only to you. The blood stem cells have been changed to have genes||
2558|029|U|that help your body make regular-shaped red blood cells and limit||
2558|030|U|the amount of sickle-shaped red blood cells. This may help to||
2558|031|U|reduce the number of painful crises caused by the disease.||
2558|032|B|||
2558|033|H|HOW TO USE:  Read the Medication Guide from your pharmacist||
2558|034|H|before you receive this product. If you have any questions, ask||
2558|035|H|your doctor or pharmacist.||
2558|036|H|   Your doctor will give you other medications (such as||
2558|037|H|chemotherapy) before treatment with this product to prepare your||
2558|038|H|body.||
2558|039|H|   This product is given by slow injection into a vein as||
2558|040|H|directed by your doctor. The dosage is based on your medical||
2558|041|H|condition and weight.||
2558|042|H|   After you receive this product, you will stay in the hospital||
2558|043|H|for about 3 to 6 weeks so your doctor can check to see if your||
2558|044|H|treatment is working and help you manage any side effects.||
2558|045|B|||
2558|046|S|SIDE EFFECTS:  See also Warning section.||
2558|047|S|   Nausea, flushing, dizziness, or decreased appetite may occur.||
2558|048|S|If any of these effects last or get worse, tell your doctor or||
2558|049|S|pharmacist promptly.||
2558|050|S|   Pain or sores in the mouth and throat may occur. Brush your||
2558|051|S|teeth carefully/gently, avoid using mouthwash that contains||
2558|052|S|alcohol, and rinse your mouth often with cool water mixed with||
2558|053|S|baking soda or salt. It may also be best to eat soft, moist||
2558|054|S|foods.||
2558|055|S|   Remember that this medication has been prescribed because your||
2558|056|S|doctor has judged that the benefit to you is greater than the||
2558|057|S|risk of side effects. Many people using this medication do not||
2558|058|S|have serious side effects.||
2558|059|S|   Treatment with this product may lead to a low number of blood||
2558|060|S|cells such as red cells, white cells, and platelets. This effect||
2558|061|S|can cause anemia, decrease your body's ability to fight an||
2558|062|S|infection, or cause easy bruising/bleeding. Tell your doctor||
2558|063|S|right away if you develop any of the following symptoms: unusual||
2558|064|S|tiredness, pale skin, signs of infection (such as sore throat||
2558|065|S|that doesn't go away, fever, chills), easy bruising/bleeding.||
2558|066|S|   A very serious allergic reaction to this drug is rare.||
2558|067|S|However, get medical help right away if you notice any symptoms||
2558|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2558|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2558|070|S|breathing.||
2558|071|S|   This is not a complete list of possible side effects. If you||
2558|072|S|notice other effects not listed above, contact your doctor or||
2558|073|S|pharmacist.||
2558|074|S|   In the US -||
2558|075|S|   Call your doctor for medical advice about side effects. You||
2558|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2558|077|S|www.fda.gov/medwatch.||
2558|078|S|   In Canada - Call your doctor for medical advice about side||
2558|079|S|effects. You may report side effects to Health Canada at||
2558|080|S|1-866-234-2345.||
2558|081|B|||
2558|082|P|PRECAUTIONS:  Before receiving lovotibeglogene autotemcel, tell||
2558|083|P|your doctor or pharmacist if you have any allergies. This product||
2558|084|P|may contain inactive ingredients, which can cause allergic||
2558|085|P|reactions or other problems. Talk to your pharmacist for more||
2558|086|P|details.||
2558|087|P|   Before using this product, tell your doctor or pharmacist your||
2558|088|P|medical history, especially of: past/current/recent infection||
2558|089|P|(including hepatitis, HIV), kidney problems, liver problems.||
2558|090|P|   This product can make you more likely to get infections or may||
2558|091|P|make current infections worse. Stay away from anyone who has an||
2558|092|P|infection that may easily spread (such as chickenpox, COVID-19,||
2558|093|P|measles, flu). Talk to your doctor if you have been exposed to an||
2558|094|P|infection or for more details.||
2558|095|P|   Tell your health care professional that you have received this||
2558|096|P|product before having any immunizations/vaccinations. Avoid||
2558|097|P|contact with people who have recently received live vaccines||
2558|098|P|(such as flu vaccine inhaled through the nose).||
2558|099|P|   To lower the chance of getting cut, bruised, or injured, use||
2558|100|P|caution with sharp objects like razors and nail cutters, and||
2558|101|P|avoid activities such as contact sports.||
2558|102|P|   Before having surgery, tell your doctor or dentist about all||
2558|103|P|the products you use (including prescription drugs,||
2558|104|P|nonprescription drugs, and herbal products).||
2558|105|P|   Tell your doctor if you are pregnant or plan to become||
2558|106|P|pregnant. You should not become pregnant while using||
2558|107|P|lovotibeglogene autotemcel. This medication may harm an unborn||
2558|108|P|baby. Your doctor should order a pregnancy test before you start||
2558|109|P|this medication. Men and women using this medication should ask||
2558|110|P|about reliable forms of birth control during treatment and for at||
2558|111|P|least 6 months after the last dose. If you or your partner||
2558|112|P|becomes pregnant, talk to your doctor right away about the risks||
2558|113|P|and benefits of this medication.||
2558|114|P|   It is unknown if this medication passes into breast milk.||
2558|115|P|Breastfeeding is not recommended while using this medication.||
2558|116|P|Consult your doctor before breastfeeding.||
2558|117|B|||
2558|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2558|119|I|medications work or increase your risk for serious side effects.||
2558|120|I|This document does not contain all possible drug interactions.||
2558|121|I|Keep a list of all the products you use (including||
2558|122|I|prescription/nonprescription drugs and herbal products) and share||
2558|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
2558|124|I|the dosage of any medicines without your doctor's approval.||
2558|125|I|   Certain medications (such as anti-retroviral drugs,||
2558|126|I|hydroxyurea) may interfere with how this product is made. If you||
2558|127|I|are using any of these, your doctor may have you stop taking them||
2558|128|I|for at least 1 to 2 months before the procedure to collect your||
2558|129|I|blood stem cells.||
2558|130|I|   This medication may interfere with certain lab tests (such as||
2558|131|I|some HIV tests), possibly causing false test results. Make sure||
2558|132|I|lab personnel and all your doctors know you use this product.||
2558|133|B|||
2558|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2558|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2558|136|O|poison control center right away. US residents can call||
2558|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2558|138|B|||
2558|139|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
2558|140|N|should be done before and after you receive this product. Keep||
2558|141|N|all medical and lab appointments.||
2558|142|N|   After receiving this treatment, do not donate blood, organs,||
2558|143|N|tissues, or cells.||
2558|144|B|||
2558|145|D|MISSED DOSE:  Not applicable.||
2558|146|B|||
2558|147|R|STORAGE:  Not applicable. This product is given in a hospital or||
2558|148|R|clinic and will not be stored at home.||
2558|149|B|||
2558|150|M|MEDICAL ALERT:  Your condition can cause complications in a||
2558|151|M|medical emergency. For information about enrolling in MedicAlert,||
2558|152|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2558|153|B|||
2558|154|A|Information last revised May 2024.||
2558|155|A|Copyright(c) 2025 First Databank, Inc.||
2558|156|B|||
2559|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2559|002|Z|does NOT have all possible information about this product. This||
2559|003|Z|information does not assure that this product is safe, effective,||
2559|004|Z|or appropriate for you. This information is not individual||
2559|005|Z|medical advice and does not substitute for the advice of your||
2559|006|Z|health care professional. Always ask your health care||
2559|007|Z|professional for complete information about this product and your||
2559|008|Z|specific health needs.||
2559|009|B|||
2559|010|T|EXAGAMGLOGENE AUTOTEMCEL - INJECTION||
2559|011|B|||
2559|012|C|COMMON BRAND NAME(S): Casgevy||
2559|013|B|||
2559|014|U|USES:  Exagamglogene autotemcel is used to treat sickle cell||
2559|015|U|disease and a certain inherited blood disorder (beta||
2559|016|U|thalassemia). Sickle cell disease causes your body to make red||
2559|017|U|blood cells that are stiff and irregularly shaped (sickle- or||
2559|018|U|crescent moon-shaped), which can lead to anemia and painful||
2559|019|U|crises. In beta thalassemia, your body does not make enough of a||
2559|020|U|certain protein (hemoglobin) that is needed to carry oxygen to||
2559|021|U|many parts of your body.||
2559|022|U|   This type of treatment is known as gene therapy. Your||
2559|023|U|exagamglogene autotemcel is made from your own blood stem cells||
2559|024|U|and is given only to you. The blood stem cells have been changed||
2559|025|U|to have genes that work properly so that you can make increased||
2559|026|U|amounts of hemoglobin. This may help reduce the number of painful||
2559|027|U|crises caused by sickle cell disease and help you not need||
2559|028|U|regular blood transfusions for beta thalassemia.||
2559|029|B|||
2559|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2559|031|H|from your pharmacist before you receive this product. If you have||
2559|032|H|any questions, ask your doctor or pharmacist.||
2559|033|H|   Your doctor will give you other medications (such as||
2559|034|H|chemotherapy) before treatment with this product to prepare your||
2559|035|H|body.||
2559|036|H|   This product is given by injection into a vein as directed by||
2559|037|H|your doctor. To decrease the risk of side effects, your doctor||
2559|038|H|may also give you other medications before injecting||
2559|039|H|exagamglogene autotemcel. The dosage is based on your medical||
2559|040|H|condition and weight.||
2559|041|H|   After you receive this product, you will stay in the hospital||
2559|042|H|for about 4 to 6 weeks so your doctor can check to see if your||
2559|043|H|treatment is working and help you manage any side effects.||
2559|044|B|||
2559|045|S|SIDE EFFECTS:  See also How to Use section.||
2559|046|S|   Dizziness or decreased appetite may occur. If either of these||
2559|047|S|effects lasts or gets worse, tell your doctor or pharmacist||
2559|048|S|promptly.||
2559|049|S|   Pain or sores in the mouth and throat may also occur. Brush||
2559|050|S|your teeth carefully/gently, avoid using mouthwash that contains||
2559|051|S|alcohol, and rinse your mouth often with cool water mixed with||
2559|052|S|baking soda or salt. It may also be best to eat soft, moist||
2559|053|S|foods.||
2559|054|S|   Remember that this medication has been prescribed because your||
2559|055|S|doctor has judged that the benefit to you is greater than the||
2559|056|S|risk of side effects. Many people using this medication do not||
2559|057|S|have serious side effects.||
2559|058|S|   Treatment with this product may lead to a low number of blood||
2559|059|S|cells such as red cells, white cells, and platelets. This effect||
2559|060|S|can cause anemia, decrease your body's ability to fight an||
2559|061|S|infection, or cause easy bruising/bleeding. Tell your doctor||
2559|062|S|right away if you develop any of the following symptoms: unusual||
2559|063|S|tiredness, pale skin, signs of infection (such as sore throat||
2559|064|S|that doesn't go away, fever, chills), easy bruising/bleeding.||
2559|065|S|   A very serious allergic reaction to this drug is rare.||
2559|066|S|However, get medical help right away if you notice any symptoms||
2559|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2559|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2559|069|S|breathing.||
2559|070|S|   This is not a complete list of possible side effects. If you||
2559|071|S|notice other effects not listed above, contact your doctor or||
2559|072|S|pharmacist.||
2559|073|S|   In the US -||
2559|074|S|   Call your doctor for medical advice about side effects. You||
2559|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2559|076|S|www.fda.gov/medwatch.||
2559|077|S|   In Canada - Call your doctor for medical advice about side||
2559|078|S|effects. You may report side effects to Health Canada at||
2559|079|S|1-866-234-2345.||
2559|080|B|||
2559|081|P|PRECAUTIONS:  Before receiving exagamglogene autotemcel, tell||
2559|082|P|your doctor or pharmacist if you have any allergies. This product||
2559|083|P|may contain inactive ingredients, which can cause allergic||
2559|084|P|reactions or other problems. Talk to your pharmacist for more||
2559|085|P|details.||
2559|086|P|   Before using this product, tell your doctor or pharmacist your||
2559|087|P|medical history, especially of: past/current/recent infection||
2559|088|P|(including hepatitis, HIV), kidney problems, liver problems.||
2559|089|P|   This product can make you more likely to get infections or may||
2559|090|P|make current infections worse. Stay away from anyone who has an||
2559|091|P|infection that may easily spread (such as chickenpox, COVID-19,||
2559|092|P|measles, flu). Talk to your doctor if you have been exposed to an||
2559|093|P|infection or for more details.||
2559|094|P|   Tell your health care professional that you have received this||
2559|095|P|product before having any immunizations/vaccinations. Avoid||
2559|096|P|contact with people who have recently received live vaccines||
2559|097|P|(such as flu vaccine inhaled through the nose).||
2559|098|P|   To lower the chance of getting cut, bruised, or injured, use||
2559|099|P|caution with sharp objects like razors and nail cutters, and||
2559|100|P|avoid activities such as contact sports.||
2559|101|P|   Before having surgery, tell your doctor or dentist about all||
2559|102|P|the products you use (including prescription drugs,||
2559|103|P|nonprescription drugs, and herbal products).||
2559|104|P|   Tell your doctor if you are pregnant or plan to become||
2559|105|P|pregnant. You should not become pregnant while using||
2559|106|P|exagamglogene autotemcel. This medication may harm an unborn||
2559|107|P|baby. Your doctor should order a pregnancy test before you start||
2559|108|P|this medication. Men and women using this medication should ask||
2559|109|P|about reliable forms of birth control during treatment and for at||
2559|110|P|least 6 months after the last dose. If you or your partner||
2559|111|P|becomes pregnant, talk to your doctor right away about the risks||
2559|112|P|and benefits of this medication.||
2559|113|P|   It is unknown if this medication passes into breast milk.||
2559|114|P|Consult your doctor before breastfeeding.||
2559|115|B|||
2559|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2559|117|I|medications work or increase your risk for serious side effects.||
2559|118|I|This document does not contain all possible drug interactions.||
2559|119|I|Keep a list of all the products you use (including||
2559|120|I|prescription/nonprescription drugs and herbal products) and share||
2559|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
2559|122|I|the dosage of any medicines without your doctor's approval.||
2559|123|I|   Certain medications (such as hydroxyurea) may affect how this||
2559|124|I|product is made. If you are taking hydroxyurea, your doctor may||
2559|125|I|have you stop taking it for at least 8 weeks before the procedure||
2559|126|I|to collect your blood stem cells.||
2559|127|B|||
2559|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2559|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2559|130|O|poison control center right away. US residents can call||
2559|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2559|132|B|||
2559|133|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
2559|134|N|should be done before and after you receive this product. Keep||
2559|135|N|all medical and lab appointments. Consult your doctor for more||
2559|136|N|details.||
2559|137|N|   After receiving this treatment, do not donate blood, organs,||
2559|138|N|tissues, or cells.||
2559|139|B|||
2559|140|D|MISSED DOSE:  Not applicable.||
2559|141|B|||
2559|142|R|STORAGE:  Not applicable. This product is given in a hospital and||
2559|143|R|will not be stored at home.||
2559|144|B|||
2559|145|M|MEDICAL ALERT:  Your condition can cause complications in a||
2559|146|M|medical emergency. For information about enrolling in MedicAlert,||
2559|147|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2559|148|B|||
2559|149|A|Information last revised July 2024.||
2559|150|A|Copyright(c) 2025 First Databank, Inc.||
2559|151|B|||
2560|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2560|002|Z|does NOT have all possible information about this product. This||
2560|003|Z|information does not assure that this product is safe, effective,||
2560|004|Z|or appropriate for you. This information is not individual||
2560|005|Z|medical advice and does not substitute for the advice of your||
2560|006|Z|health care professional. Always ask your health care||
2560|007|Z|professional for complete information about this product and your||
2560|008|Z|specific health needs.||
2560|009|B|||
2560|010|T|EFLORNITHINE - ORAL||
2560|011|F|(ef-LOR-ni-theen)||
2560|012|B|||
2560|013|C|COMMON BRAND NAME(S): Iwilfin||
2560|014|B|||
2560|015|U|USES:  This medication is used to treat a certain type of cancer||
2560|016|U|(high-risk neuroblastoma). Eflornithine works by slowing or||
2560|017|U|stopping the growth of cancer cells.||
2560|018|B|||
2560|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2560|020|H|from your pharmacist before you start taking eflornithine and||
2560|021|H|each time you get a refill. If you have any questions, ask your||
2560|022|H|doctor or pharmacist.||
2560|023|H|   Take this medication by mouth with or without food as directed||
2560|024|H|by your doctor, usually twice daily. The dosage is based on your||
2560|025|H|medical condition, body size, and response to treatment.||
2560|026|H|   If you have trouble swallowing the tablet, it may be chewed.||
2560|027|H|It may also be crushed and mixed in two tablespoons (1 ounce/30||
2560|028|H|milliliters) of soft food or liquid. If crushed particles remain,||
2560|029|H|you may mix with another two tablespoons (1 ounce/30 milliliters)||
2560|030|H|of soft food or liquid. Swallow the mixture within one hour of||
2560|031|H|mixing it.||
2560|032|H|   If you vomit after taking a dose, do not take another dose at||
2560|033|H|that time. Take your next dose at the regular time.||
2560|034|H|   Use this medication regularly to get the most benefit from it.||
2560|035|H|To help you remember, take it at the same times each day.||
2560|036|H|   Do not increase your dose or use this drug more often or for||
2560|037|H|longer than prescribed. Your condition will not improve any||
2560|038|H|faster, and your risk of serious side effects will increase.||
2560|039|H|   Since this drug can be absorbed through the skin and lungs and||
2560|040|H|may harm an unborn baby, women who are pregnant or who may become||
2560|041|H|pregnant should not handle this medication or breathe the dust||
2560|042|H|from the tablets.||
2560|043|B|||
2560|044|S|SIDE EFFECTS:  Vomiting or diarrhea may occur. Your doctor may||
2560|045|S|prescribe other medications to control the diarrhea/vomiting or||
2560|046|S|may stop/lower the dose of eflornithine. If either of these||
2560|047|S|effects lasts or gets worse, tell your doctor or pharmacist||
2560|048|S|promptly.||
2560|049|S|   People using this medication may have serious side effects.||
2560|050|S|However, you have been prescribed this drug because your doctor||
2560|051|S|has judged that the benefit to you is greater than the risk of||
2560|052|S|side effects. Careful monitoring by your doctor may decrease your||
2560|053|S|risk.||
2560|054|S|   Tell your doctor right away if you have any serious side||
2560|055|S|effects, including: hearing problems (such as new/worsening||
2560|056|S|hearing loss, ringing in the ears), signs of liver problems (such||
2560|057|S|as nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
2560|058|S|urine, stomach/abdominal pain).||
2560|059|S|   This medication decreases bone marrow function, an effect that||
2560|060|S|may lead to a low number of blood cells such as red cells, white||
2560|061|S|cells, and platelets. This effect can cause anemia, decrease your||
2560|062|S|body's ability to fight an infection, or cause easy||
2560|063|S|bruising/bleeding. Tell your doctor right away if you develop any||
2560|064|S|of the following symptoms: unusual tiredness, pale skin, signs of||
2560|065|S|infection (such as sore throat that doesn't go away, fever,||
2560|066|S|chills), easy bruising/bleeding.||
2560|067|S|   A very serious allergic reaction to this drug is rare.||
2560|068|S|However, get medical help right away if you notice any symptoms||
2560|069|S|of a serious allergic reaction, including: rash, itching/swelling||
2560|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2560|071|S|breathing.||
2560|072|S|   This is not a complete list of possible side effects. If you||
2560|073|S|notice other effects not listed above, contact your doctor or||
2560|074|S|pharmacist.||
2560|075|S|   In the US -||
2560|076|S|   Call your doctor for medical advice about side effects. You||
2560|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2560|078|S|www.fda.gov/medwatch.||
2560|079|S|   In Canada - Call your doctor for medical advice about side||
2560|080|S|effects. You may report side effects to Health Canada at||
2560|081|S|1-866-234-2345.||
2560|082|B|||
2560|083|P|PRECAUTIONS:  Before taking eflornithine, tell your doctor or||
2560|084|P|pharmacist if you are allergic to it; or if you have any other||
2560|085|P|allergies. This product may contain inactive ingredients, which||
2560|086|P|can cause allergic reactions or other problems. Talk to your||
2560|087|P|pharmacist for more details.||
2560|088|P|   Before using this medication, tell your doctor or pharmacist||
2560|089|P|your medical history, especially of: hearing problems, kidney||
2560|090|P|problems.||
2560|091|P|   Eflornithine can make you more likely to get infections or may||
2560|092|P|worsen any current infections. Avoid contact with people who have||
2560|093|P|infections that may spread to others (such as chickenpox,||
2560|094|P|measles, flu). Consult your doctor if you have been exposed to an||
2560|095|P|infection or for more details.||
2560|096|P|   Do not have immunizations/vaccinations without the consent of||
2560|097|P|your doctor. Avoid contact with people who have recently received||
2560|098|P|live vaccines (such as flu vaccine inhaled through the nose).||
2560|099|P|   To lower the chance of getting cut, bruised, or injured, use||
2560|100|P|caution with sharp objects like razors and nail cutters, and||
2560|101|P|avoid activities such as contact sports.||
2560|102|P|   Before having surgery, tell your doctor or dentist about all||
2560|103|P|the products you use (including prescription drugs,||
2560|104|P|nonprescription drugs, and herbal products).||
2560|105|P|   Tell your doctor if you are pregnant or plan to become||
2560|106|P|pregnant. You should not become pregnant while using||
2560|107|P|eflornithine. Eflornithine may harm an unborn baby. Your doctor||
2560|108|P|should order a pregnancy test before you start this medication.||
2560|109|P|Men and women using this medication should ask about reliable||
2560|110|P|forms of birth control during treatment and for 1 week after the||
2560|111|P|last dose. If you or your partner becomes pregnant, talk to your||
2560|112|P|doctor right away about the risks and benefits of this||
2560|113|P|medication.||
2560|114|P|   Since this drug can be absorbed through the skin and lungs and||
2560|115|P|may harm an unborn baby, women who are pregnant or who may become||
2560|116|P|pregnant should not handle this medication or breathe the dust||
2560|117|P|from the tablets.||
2560|118|P|   It is unknown if this medication passes into breast milk.||
2560|119|P|Because of the possible risk to the infant, breastfeeding is not||
2560|120|P|recommended while using this medication and for 1 week after the||
2560|121|P|last dose. Consult your doctor before breastfeeding.||
2560|122|B|||
2560|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2560|124|I|medications work or increase your risk for serious side effects.||
2560|125|I|This document does not contain all possible drug interactions.||
2560|126|I|Keep a list of all the products you use (including||
2560|127|I|prescription/nonprescription drugs and herbal products) and share||
2560|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
2560|129|I|the dosage of any medicines without your doctor's approval.||
2560|130|B|||
2560|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2560|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2560|133|O|poison control center right away. US residents can call||
2560|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2560|135|B|||
2560|136|N|NOTES:  Do not share this medication with others.||
2560|137|N|   Lab and/or medical tests (such as complete blood count,||
2560|138|N|liver/kidney function, hearing test) should be done before you||
2560|139|N|start taking this medication and while you are taking it. Keep||
2560|140|N|all medical and lab appointments. Consult your doctor for more||
2560|141|N|details.||
2560|142|B|||
2560|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2560|144|D|remember. If it is within 7 hours of the next dose, skip the||
2560|145|D|missed dose. Take your next dose at the regular time. Do not||
2560|146|D|double the dose to catch up.||
2560|147|B|||
2560|148|R|STORAGE:  Store at room temperature away from light and moisture.||
2560|149|R|Do not store in the bathroom. Keep all medications away from||
2560|150|R|children and pets.||
2560|151|R|   Do not flush medications down the toilet or pour them into a||
2560|152|R|drain unless instructed to do so. Properly discard this product||
2560|153|R|when it is expired or no longer needed. Consult your pharmacist||
2560|154|R|or local waste disposal company.||
2560|155|B|||
2560|156|M|MEDICAL ALERT:  Your condition can cause complications in a||
2560|157|M|medical emergency. For information about enrolling in MedicAlert,||
2560|158|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2560|159|B|||
2560|160|A|Information last revised December 2024.||
2560|161|A|Copyright(c) 2025 First Databank, Inc.||
2560|162|B|||
2561|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2561|002|Z|does NOT have all possible information about this product. This||
2561|003|Z|information does not assure that this product is safe, effective,||
2561|004|Z|or appropriate for you. This information is not individual||
2561|005|Z|medical advice and does not substitute for the advice of your||
2561|006|Z|health care professional. Always ask your health care||
2561|007|Z|professional for complete information about this product and your||
2561|008|Z|specific health needs.||
2561|009|B|||
2561|010|T|TRAVOPROST IMPLANT - INTRAOCULAR||
2561|011|F|(TRA-voh-prost)||
2561|012|B|||
2561|013|C|COMMON BRAND NAME(S): iDose TR||
2561|014|B|||
2561|015|U|USES:  Travoprost is used to treat high pressure inside the eye||
2561|016|U|due to glaucoma (open-angle type) or other eye diseases (such as||
2561|017|U|ocular hypertension). Lowering high pressure inside the eye can||
2561|018|U|help prevent blindness. This medication may lower pressure inside||
2561|019|U|the eye by helping fluid inside the eye flow out.||
2561|020|U|   This implant may be placed only one time in each eye.||
2561|021|B|||
2561|022|H|HOW TO USE:  This medication implant is placed in the eye(s) by a||
2561|023|H|health care professional.||
2561|024|H|   Rarely, the implant may move out of place. Your doctor will||
2561|025|H|monitor the position of the implant in the eye with regular eye||
2561|026|H|exams.||
2561|027|H|   Most people with glaucoma or high pressure in the eye do not||
2561|028|H|have symptoms. To monitor the effect of this medication implant,||
2561|029|H|keep all medical appointments with your doctor.||
2561|030|B|||
2561|031|S|SIDE EFFECTS:  Eye swelling, dry eye, or blurred vision may occur||
2561|032|S|after the procedure. If any of these effects last or get worse,||
2561|033|S|tell your doctor or pharmacist promptly.||
2561|034|S|   This medication may slowly (over months to years) cause brown||
2561|035|S|discoloration of the colored portion of the eye (iris). If you||
2561|036|S|are using this product in only one eye, only that iris may change||
2561|037|S|color. These changes may be permanent, but the long-term effects||
2561|038|S|are unknown. Tell your doctor if this occurs, and schedule||
2561|039|S|regular eye exams to monitor it.||
2561|040|S|   Remember that this medication has been prescribed because your||
2561|041|S|doctor has judged that the benefit to you is greater than the||
2561|042|S|risk of side effects. Many people using this medication do not||
2561|043|S|have serious side effects.||
2561|044|S|   Tell your doctor right away if you have any serious side||
2561|045|S|effects, including: vision changes, eye redness/pain/sensitivity||
2561|046|S|to light.||
2561|047|S|   A very serious allergic reaction to this drug is rare.||
2561|048|S|However, get medical help right away if you notice any symptoms||
2561|049|S|of a serious allergic reaction, including: rash, itching/swelling||
2561|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2561|051|S|breathing.||
2561|052|S|   This is not a complete list of possible side effects. If you||
2561|053|S|notice other effects not listed above, contact your doctor or||
2561|054|S|pharmacist.||
2561|055|S|   In the US -||
2561|056|S|   Call your doctor for medical advice about side effects. You||
2561|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2561|058|S|www.fda.gov/medwatch.||
2561|059|S|   In Canada - Call your doctor for medical advice about side||
2561|060|S|effects. You may report side effects to Health Canada at||
2561|061|S|1-866-234-2345.||
2561|062|B|||
2561|063|P|PRECAUTIONS:  Before using travoprost, tell your doctor or||
2561|064|P|pharmacist if you are allergic to it; or if you have any other||
2561|065|P|allergies. This product may contain inactive ingredients, which||
2561|066|P|can cause allergic reactions or other problems. Talk to your||
2561|067|P|pharmacist for more details.||
2561|068|P|   Before using this medication, tell your doctor or pharmacist||
2561|069|P|your medical history, especially of: other eye problems (such as||
2561|070|P|eye infection, problems with the cornea or posterior lens||
2561|071|P|capsule, uveitis), previous eye surgery (such as corneal||
2561|072|P|transplant, endothelial cell transplant).||
2561|073|P|   This drug may cause blurred vision. Do not drive, use||
2561|074|P|machinery, or do anything that needs clear vision until you can||
2561|075|P|do it safely.||
2561|076|P|   Before having surgery, tell your doctor or dentist about all||
2561|077|P|the products you use (including prescription drugs,||
2561|078|P|nonprescription drugs, and herbal products). Also, if you are||
2561|079|P|going to have an MRI test, tell testing personnel that you have||
2561|080|P|this implant. You may only receive an MRI under very specific||
2561|081|P|conditions if you have this implant.||
2561|082|P|   During pregnancy, this medication should be used only when||
2561|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
2561|084|P|   It is unknown if this drug passes into breast milk. Consult||
2561|085|P|your doctor before breastfeeding.||
2561|086|B|||
2561|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2561|088|I|medications work or increase your risk for serious side effects.||
2561|089|I|This document does not contain all possible drug interactions.||
2561|090|I|Keep a list of all the products you use (including||
2561|091|I|prescription/nonprescription drugs and herbal products) and share||
2561|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
2561|093|I|the dosage of any medicines without your doctor's approval.||
2561|094|B|||
2561|095|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2561|096|O|has overdosed and has serious symptoms such as passing out or||
2561|097|O|trouble breathing, call 911. Otherwise, call a poison control||
2561|098|O|center right away. US residents can call 1-800-222-1222. Canada||
2561|099|O|residents can call 1-844-764-7669.||
2561|100|B|||
2561|101|N|NOTES:  Lab and/or medical tests (such as eye exams) may be done||
2561|102|N|while you are using this medication. Keep all medical and lab||
2561|103|N|appointments. Consult your doctor for more details.||
2561|104|B|||
2561|105|D|MISSED DOSE:  Not applicable.||
2561|106|B|||
2561|107|R|STORAGE:  Not applicable. This type of product is given in a||
2561|108|R|hospital or clinic or doctor's office and will not be stored at||
2561|109|R|home.||
2561|110|B|||
2561|111|A|Information last revised May 2024.||
2561|112|A|Copyright(c) 2025 First Databank, Inc.||
2561|113|B|||
2562|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2562|002|Z|does NOT have all possible information about this product. This||
2562|003|Z|information does not assure that this product is safe, effective,||
2562|004|Z|or appropriate for you. This information is not individual||
2562|005|Z|medical advice and does not substitute for the advice of your||
2562|006|Z|health care professional. Always ask your health care||
2562|007|Z|professional for complete information about this product and your||
2562|008|Z|specific health needs.||
2562|009|B|||
2562|010|T|EPLONTERSEN - INJECTION||
2562|011|F|(EP-lon-TER-sen)||
2562|012|B|||
2562|013|C|COMMON BRAND NAME(S): Wainua||
2562|014|B|||
2562|015|U|USES:  This medication is used to treat nerve problems due to a||
2562|016|U|certain inherited condition (transthyretin-mediated amyloidosis).||
2562|017|U|This condition causes a protein that your body normally makes||
2562|018|U|(transthyretin-TTR) to change shape and build up in different||
2562|019|U|parts of your body, which can affect the nerves, heart, eyes, and||
2562|020|U|stomach/intestines. This medication works by decreasing the||
2562|021|U|buildup of TTR in your body.||
2562|022|B|||
2562|023|H|HOW TO USE:  Read the Patient Information Leaflet and||
2562|024|H|Instructions for Use if available from your pharmacist before you||
2562|025|H|start using eplontersen and each time you get a refill. Ask your||
2562|026|H|health care professional how to prepare and use this medication.||
2562|027|H|If you have any questions, ask your doctor or pharmacist.||
2562|028|H|   Inject this medication under the skin as directed by your||
2562|029|H|doctor, usually once a month. The injection is given in the upper||
2562|030|H|arm, upper thigh, or abdomen.||
2562|031|H|   Take the medication out of the refrigerator at least 30||
2562|032|H|minutes before you inject it to allow it to reach room||
2562|033|H|temperature. Do not warm up this medication any other way (for||
2562|034|H|example, do not heat it in the microwave or place it in hot||
2562|035|H|water). Before using, check this product for particles or||
2562|036|H|discoloration. If either is present, do not use the liquid.||
2562|037|H|Before injecting each dose, clean the skin you are going to||
2562|038|H|inject into (the injection site) with rubbing alcohol. Change the||
2562|039|H|injection site each time to lessen injury under the skin. Do not||
2562|040|H|inject into skin that is bruised, tender, red, hard, or tattooed,||
2562|041|H|or into scars. To lessen bruising, do not rub the injection site||
2562|042|H|after a shot. Learn how to store and discard medical supplies||
2562|043|H|safely.||
2562|044|H|   Use this medication regularly to get the most benefit from it.||
2562|045|H|To help you remember, inject this medication on the same day each||
2562|046|H|month.||
2562|047|B|||
2562|048|S|SIDE EFFECTS:  Bruising, redness, itching, pain, or swelling at||
2562|049|S|the injection site may occur. Vomiting may also occur. If any of||
2562|050|S|these effects last or get worse, tell your doctor or pharmacist||
2562|051|S|promptly.||
2562|052|S|   Remember that this medication has been prescribed because your||
2562|053|S|doctor has judged that the benefit to you is greater than the||
2562|054|S|risk of side effects. Many people using this medication do not||
2562|055|S|have serious side effects.||
2562|056|S|   This medication decreases vitamin A levels in your blood. Ask||
2562|057|S|your doctor about taking a vitamin A supplement. Tell your doctor||
2562|058|S|right away if you develop signs of a lack of vitamin A,||
2562|059|S|especially vision changes such as dry eyes, blurred vision, or||
2562|060|S|trouble seeing in dim light (night blindness).||
2562|061|S|   A very serious allergic reaction to this drug is rare.||
2562|062|S|However, get medical help right away if you notice any symptoms||
2562|063|S|of a serious allergic reaction, including: rash, itching/swelling||
2562|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2562|065|S|breathing.||
2562|066|S|   This is not a complete list of possible side effects. If you||
2562|067|S|notice other effects not listed above, contact your doctor or||
2562|068|S|pharmacist.||
2562|069|S|   In the US -||
2562|070|S|   Call your doctor for medical advice about side effects. You||
2562|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2562|072|S|www.fda.gov/medwatch.||
2562|073|S|   In Canada - Call your doctor for medical advice about side||
2562|074|S|effects. You may report side effects to Health Canada at||
2562|075|S|1-866-234-2345.||
2562|076|B|||
2562|077|P|PRECAUTIONS:  Before using eplontersen, tell your doctor or||
2562|078|P|pharmacist if you are allergic to it; or if you have any other||
2562|079|P|allergies. This product may contain inactive ingredients which||
2562|080|P|can cause allergic reactions or other problems. Talk to your||
2562|081|P|pharmacist for more details.||
2562|082|P|   Before using this medication, tell your doctor or pharmacist||
2562|083|P|your medical history.||
2562|084|P|   Before having surgery, tell your doctor or dentist about all||
2562|085|P|the products you use (including prescription drugs,||
2562|086|P|nonprescription drugs, and herbal products).||
2562|087|P|   During pregnancy, this medication should be used only when||
2562|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
2562|089|P|   It is unknown if this medication passes into breast milk.||
2562|090|P|Consult your doctor before breastfeeding.||
2562|091|B|||
2562|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2562|093|I|medications work or increase your risk for serious side effects.||
2562|094|I|This document does not contain all possible drug interactions.||
2562|095|I|Keep a list of all the products you use (including||
2562|096|I|prescription/nonprescription drugs and herbal products) and share||
2562|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
2562|098|I|the dosage of any medicines without your doctor's approval.||
2562|099|B|||
2562|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2562|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2562|102|O|poison control center right away. US residents can call||
2562|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2562|104|B|||
2562|105|N|NOTES:  Do not share this medication with others.||
2562|106|N|   Lab and/or medical tests may be done while you are using this||
2562|107|N|medication. Keep all medical and lab appointments.||
2562|108|B|||
2562|109|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2562|110|D|Keep using your next dose 1 month from the date of the last dose.||
2562|111|D|Do not double the dose to catch up.||
2562|112|B|||
2562|113|R|STORAGE:  Store in the refrigerator. Do not freeze or expose to||
2562|114|R|heat. Keep the medication in the original package to protect from||
2562|115|R|light. This medication may also be stored at room temperature if||
2562|116|R|needed. If the medication is stored at room temperature, discard||
2562|117|R|after 6 weeks. Keep all medications away from children and pets.||
2562|118|R|   Do not flush medications down the toilet or pour them into a||
2562|119|R|drain unless instructed to do so. Properly discard this product||
2562|120|R|when it is expired or no longer needed. Consult your pharmacist||
2562|121|R|or local waste disposal company.||
2562|122|B|||
2562|123|A|Information last revised October 2024.||
2562|124|A|Copyright(c) 2025 First Databank, Inc.||
2562|125|B|||
2563|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2563|002|Z|does NOT have all possible information about this product. This||
2563|003|Z|information does not assure that this product is safe, effective,||
2563|004|Z|or appropriate for you. This information is not individual||
2563|005|Z|medical advice and does not substitute for the advice of your||
2563|006|Z|health care professional. Always ask your health care||
2563|007|Z|professional for complete information about this product and your||
2563|008|Z|specific health needs.||
2563|009|B|||
2563|010|T|VAMOROLONE - ORAL||
2563|011|F|(va-MOR-oh-lone)||
2563|012|B|||
2563|013|C|COMMON BRAND NAME(S): Agamree||
2563|014|B|||
2563|015|U|USES:  This medication is used to treat a certain inherited||
2563|016|U|muscle disorder (Duchenne muscular dystrophy-DMD). Vamorolone||
2563|017|U|belongs to a class of drugs known as corticosteroids.||
2563|018|B|||
2563|019|H|HOW TO USE:  Read the Instructions for Use if available from your||
2563|020|H|pharmacist before you start taking vamorolone and each time you||
2563|021|H|get a refill. If you have any questions, ask your doctor or||
2563|022|H|pharmacist.||
2563|023|H|   Take this medication by mouth with a meal as directed by your||
2563|024|H|doctor, usually once daily.||
2563|025|H|   Shake the bottle well for 30 seconds before each dose.||
2563|026|H|Carefully measure the dose using the oral syringe that comes with||
2563|027|H|the medication. Do not use a household spoon because you may not||
2563|028|H|get the correct dose. Swallow the medication directly from the||
2563|029|H|syringe. Do not mix it with water or other liquids. Rinse the||
2563|030|H|syringe with water after each use. Consult your doctor or||
2563|031|H|pharmacist if you have any questions.||
2563|032|H|   The dosage is based on your medical condition, response to||
2563|033|H|treatment, weight, and other medications you may be taking. Be||
2563|034|H|sure to tell your doctor and pharmacist about all the products||
2563|035|H|you use (including prescription drugs, nonprescription drugs, and||
2563|036|H|herbal products).||
2563|037|H|   Use this medication regularly to get the most benefit from it.||
2563|038|H|To help you remember, take it at the same time each day.||
2563|039|H|   Do not increase your dose or use this drug more often or for||
2563|040|H|longer than prescribed. Your condition will not improve any||
2563|041|H|faster, and your risk of side effects will increase.||
2563|042|H|   Do not stop taking this medication without consulting your||
2563|043|H|doctor. Some conditions may become worse when this drug is||
2563|044|H|suddenly stopped. Also, you may experience symptoms such as||
2563|045|H|weakness, weight loss, nausea, vomiting, muscle pain, headache,||
2563|046|H|and tiredness. To prevent these symptoms while you are stopping||
2563|047|H|treatment with this drug, your doctor may reduce your dose||
2563|048|H|gradually. Consult your doctor or pharmacist for more details.||
2563|049|H|Report any new or worsening symptoms right away.||
2563|050|B|||
2563|051|S|SIDE EFFECTS:  Vomiting, diarrhea, or weight gain may occur. If||
2563|052|S|any of these effects last or get worse, tell your doctor or||
2563|053|S|pharmacist promptly.||
2563|054|S|   Remember that this medication has been prescribed because your||
2563|055|S|doctor has judged that the benefit to you is greater than the||
2563|056|S|risk of side effects. Many people using this medication do not||
2563|057|S|have serious side effects.||
2563|058|S|   Tell your doctor right away if you have any serious side||
2563|059|S|effects, including: weakness, puffy face, unusual weight gain,||
2563|060|S|swelling ankles/feet/hands, slow wound healing, thinning skin,||
2563|061|S|bone pain, menstrual period changes, mental/mood changes (such as||
2563|062|S|depression, mood swings, agitation), easy bruising/bleeding,||
2563|063|S|symptoms of stomach/intestinal bleeding (such as||
2563|064|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
2563|065|S|coffee grounds), vision problems, red/purple spots on the skin.||
2563|066|S|   This medication may rarely make your blood sugar rise, which||
2563|067|S|can cause or worsen diabetes. Tell your doctor right away if you||
2563|068|S|have symptoms of high blood sugar such as increased||
2563|069|S|thirst/urination. If you already have diabetes, check your blood||
2563|070|S|sugar regularly as directed and share the results with your||
2563|071|S|doctor. Your doctor may need to adjust your diabetes medication,||
2563|072|S|exercise program, or diet.||
2563|073|S|   This medication may lower your ability to fight infections.||
2563|074|S|This may make you more likely to get a serious (rarely fatal)||
2563|075|S|infection or make any infection you have worse. Tell your doctor||
2563|076|S|right away if you have any signs of infection (such as sore||
2563|077|S|throat that doesn't go away, fever, chills).||
2563|078|S|   A very serious allergic reaction to this drug is rare.||
2563|079|S|However, get medical help right away if you notice any symptoms||
2563|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2563|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2563|082|S|breathing.||
2563|083|S|   This is not a complete list of possible side effects. If you||
2563|084|S|notice other effects not listed above, contact your doctor or||
2563|085|S|pharmacist.||
2563|086|S|   In the US -||
2563|087|S|   Call your doctor for medical advice about side effects. You||
2563|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2563|089|S|www.fda.gov/medwatch.||
2563|090|S|   In Canada - Call your doctor for medical advice about side||
2563|091|S|effects. You may report side effects to Health Canada at||
2563|092|S|1-866-234-2345.||
2563|093|B|||
2563|094|P|PRECAUTIONS:  Before taking vamorolone, tell your doctor or||
2563|095|P|pharmacist if you are allergic to it; or if you have any other||
2563|096|P|allergies. This product may contain inactive ingredients, which||
2563|097|P|can cause allergic reactions or other problems. Talk to your||
2563|098|P|pharmacist for more details.||
2563|099|P|   Before using this medication, tell your doctor or pharmacist||
2563|100|P|your medical history, especially of: infections (such as||
2563|101|P|tuberculosis, herpes, fungal infections), high blood pressure,||
2563|102|P|heart problems (such as heart failure, recent heart attack),||
2563|103|P|kidney disease, liver disease (such as hepatitis B), mental/mood||
2563|104|P|disorders (such as psychosis, anxiety, depression), mineral||
2563|105|P|imbalance (such as low level of potassium/calcium in the blood),||
2563|106|P|thyroid disease, stomach/intestinal problems (such as ulcer,||
2563|107|P|ulcerative colitis, diverticulitis, unexplained diarrhea),||
2563|108|P|diabetes, eye problems (such as cataracts, glaucoma), bone loss||
2563|109|P|(osteoporosis), blood clots, a certain adrenal gland tumor||
2563|110|P|(pheochromocytoma).||
2563|111|P|   Using corticosteroid medications for a long time can make it||
2563|112|P|more difficult for your body to respond to physical stress.||
2563|113|P|Before having surgery or emergency treatment, or if you get a||
2563|114|P|serious illness/injury, tell your doctor or dentist that you are||
2563|115|P|using this medication or have used this medication within the||
2563|116|P|past 12 months. Tell your doctor right away if you develop||
2563|117|P|unusual/extreme tiredness or weight loss. If you will be using||
2563|118|P|this medication for a long time, carry a warning card or medical||
2563|119|P|ID bracelet that identifies your use of this medication.||
2563|120|P|   Vamorolone can make you more likely to get infections or may||
2563|121|P|make current infections worse. Stay away from anyone who has an||
2563|122|P|infection that may easily spread (such as chickenpox, COVID-19,||
2563|123|P|measles, flu). Talk to your doctor if you have been exposed to an||
2563|124|P|infection or for more details.||
2563|125|P|   Tell your health care professional that you are using||
2563|126|P|vamorolone before having any immunizations/vaccinations. Avoid||
2563|127|P|contact with people who have recently received live vaccines||
2563|128|P|(such as flu vaccine inhaled through the nose).||
2563|129|P|   This medication may cause stomach bleeding. Daily use of||
2563|130|P|alcohol while using this medication may increase your risk for||
2563|131|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
2563|132|P|or pharmacist for more information.||
2563|133|P|   Before having surgery, tell your doctor or dentist about all||
2563|134|P|the products you use (including prescription drugs,||
2563|135|P|nonprescription drugs, and herbal products).||
2563|136|P|   This medication may slow down a child's growth if used for a||
2563|137|P|long time. Consult the doctor or pharmacist for more details. See||
2563|138|P|the doctor regularly so your child's height and growth can be||
2563|139|P|checked.||
2563|140|P|   During pregnancy, this medication should be used only when||
2563|141|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
2563|142|P|risks and benefits with your doctor. Infants born to mothers who||
2563|143|P|have been using this medication for an extended time may have||
2563|144|P|hormone problems. Tell your doctor right away if you notice||
2563|145|P|symptoms such as nausea/vomiting that doesn't stop, severe||
2563|146|P|diarrhea, or weakness in your newborn.||
2563|147|P|   It is unknown if this medication passes into breast milk.||
2563|148|P|Consult your doctor before breastfeeding.||
2563|149|B|||
2563|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2563|151|I|medications work or increase your risk for serious side effects.||
2563|152|I|This document does not contain all possible drug interactions.||
2563|153|I|Keep a list of all the products you use (including||
2563|154|I|prescription/nonprescription drugs and herbal products) and share||
2563|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
2563|156|I|the dosage of any medicines without your doctor's approval.||
2563|157|I|   Some products that may interact with this drug are:||
2563|158|I|desmopressin, mifepristone, drugs that can cause||
2563|159|I|bleeding/bruising (including antiplatelet drugs such as||
2563|160|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
2563|161|I|such as warfarin/dabigatran).||
2563|162|I|   If your doctor has told you to take low-dose aspirin to||
2563|163|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
2563|164|I|you should keep taking the aspirin unless your doctor tells you||
2563|165|I|not to. Ask your doctor or pharmacist for more details.||
2563|166|I|   This medication may interfere with certain lab tests (such as||
2563|167|I|skin tests), possibly causing false test results. Make sure lab||
2563|168|I|personnel and all your doctors know you use this drug.||
2563|169|B|||
2563|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2563|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2563|172|O|poison control center right away. US residents can call||
2563|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2563|174|B|||
2563|175|N|NOTES:  Do not share this medication with others.||
2563|176|N|   Lab and/or medical tests (such as blood mineral levels, blood||
2563|177|N|sugar, complete blood count, bone density, blood pressure, eye||
2563|178|N|exams) should be done while you are taking this medication. Keep||
2563|179|N|all medical and lab appointments.||
2563|180|N|   This medication may cause bone loss (osteoporosis) when used||
2563|181|N|for a long time. Lifestyle changes that may help reduce the risk||
2563|182|N|of bone problems include doing weight-bearing exercise, stopping||
2563|183|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2563|184|N|D. Talk to your doctor for more details.||
2563|185|B|||
2563|186|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2563|187|D|remember. If it is near the time of the next dose, skip the||
2563|188|D|missed dose. Take your next dose at the regular time. Do not||
2563|189|D|double the dose to catch up.||
2563|190|B|||
2563|191|R|STORAGE:  Store the unopened bottle upright in the original||
2563|192|R|carton at room temperature away from light. After opening, store||
2563|193|R|the bottle upright in the refrigerator. Do not freeze. Once the||
2563|194|R|bottle is opened, this medication expires after 3 months. Keep||
2563|195|R|all medications away from children and pets.||
2563|196|R|   Do not flush medications down the toilet or pour them into a||
2563|197|R|drain unless instructed to do so. Properly discard this product||
2563|198|R|when it is expired or no longer needed. Consult your pharmacist||
2563|199|R|or local waste disposal company.||
2563|200|B|||
2563|201|M|MEDICAL ALERT:  Your condition can cause complications in a||
2563|202|M|medical emergency. For information about enrolling in MedicAlert,||
2563|203|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2563|204|B|||
2563|205|A|Information last revised September 2025.||
2563|206|A|Copyright(c) 2025 First Databank, Inc.||
2563|207|B|||
2564|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2564|002|Z|does NOT have all possible information about this product. This||
2564|003|Z|information does not assure that this product is safe, effective,||
2564|004|Z|or appropriate for you. This information is not individual||
2564|005|Z|medical advice and does not substitute for the advice of your||
2564|006|Z|health care professional. Always ask your health care||
2564|007|Z|professional for complete information about this product and your||
2564|008|Z|specific health needs.||
2564|009|B|||
2564|010|T|IPTACOPAN - ORAL||
2564|011|B|||
2564|012|C|COMMON BRAND NAME(S): Fabhalta||
2564|013|B|||
2564|014|W|WARNING:  Iptacopan can lower your body's ability to fight||
2564|015|W|infections. This increases your chance of getting very serious||
2564|016|W|(possibly fatal) infections (especially meningitis or sepsis).||
2564|017|W|   Your doctor may prescribe certain vaccines for you to get at||
2564|018|W|least 2 weeks before your first dose of this medication. Vaccines||
2564|019|W|may not fully protect everyone who receives them, so you should||
2564|020|W|still watch for signs of infection after you get the vaccine. Get||
2564|021|W|medical help right away if you develop symptoms such as||
2564|022|W|nausea/vomiting that doesn't stop, fever, chills, severe||
2564|023|W|headache, stiff neck, mental/mood changes (such as confusion),||
2564|024|W|muscle aches with flu-like symptoms, eye sensitivity to light.||
2564|025|W|   To receive iptacopan in the United States, you must||
2564|026|W|understand, agree to, and carefully follow the requirements of||
2564|027|W|the REMS Program for this medication. If you live in Canada or||
2564|028|W|any other country, consult your doctor and pharmacist for your||
2564|029|W|country's regulations.||
2564|030|B|||
2564|031|U|USES:  Iptacopan is used to treat a certain blood disorder||
2564|032|U|(paroxysmal nocturnal hemoglobinuria - PNH). This disorder causes||
2564|033|U|your body's immune system to break down red blood cells, which||
2564|034|U|results in anemia. Iptacopan works by helping to block the body's||
2564|035|U|breakdown of red blood cells. This effect helps lessen symptoms||
2564|036|U|of anemia (such as tiredness, shortness of breath) and may reduce||
2564|037|U|the need for blood transfusions.||
2564|038|U|   This medication is also used to treat certain kidney problems||
2564|039|U|(such as primary immunoglobulin A nephropathy - IgAN, complement||
2564|040|U|3 glomerulopathy - C3G). Iptacopan helps to lower levels of||
2564|041|U|protein in the urine.||
2564|042|B|||
2564|043|H|HOW TO USE:  Read the Medication Guide provided by your||
2564|044|H|pharmacist before you start taking iptacopan and each time you||
2564|045|H|get a refill. Carry the Patient Safety Card with you at all times||
2564|046|H|during treatment and for 2 weeks after your last dose of||
2564|047|H|iptacopan. If you have any questions, ask your doctor or||
2564|048|H|pharmacist.||
2564|049|H|   Take this medication by mouth with or without food as directed||
2564|050|H|by your doctor, usually twice daily. Swallow the capsule whole.||
2564|051|H|Do not open, break, or chew the capsules.||
2564|052|H|   Do not increase your dose or use this drug more often or for||
2564|053|H|longer than prescribed. Your condition will not improve any||
2564|054|H|faster, and your risk of side effects will increase.||
2564|055|H|   Use this medication regularly to get the most benefit from it.||
2564|056|H|To help you remember, take it at the same times each day.||
2564|057|H|   If you are changing to this medication treatment from another||
2564|058|H|drug, carefully follow your doctor's directions for when to start||
2564|059|H|or stop this and your other medication(s). Do not stop taking||
2564|060|H|this medication without consulting your doctor. If you are taking||
2564|061|H|this medication for PNH, your condition may become worse when the||
2564|062|H|drug is stopped. If you do stop taking this medication, your||
2564|063|H|doctor will monitor you for at least 2 weeks after the last dose||
2564|064|H|to make sure your condition does not get worse. Consult your||
2564|065|H|doctor for more details.||
2564|066|H|   Tell your doctor if your condition does not get better or if||
2564|067|H|it gets worse.||
2564|068|B|||
2564|069|S|SIDE EFFECTS:  See also Warning section.||
2564|070|S|   Headache, cold symptoms (stuffy/runny nose, cough), nausea,||
2564|071|S|diarrhea, abdominal pain, joint pain, or dizziness may occur. If||
2564|072|S|any of these effects last or get worse, tell your doctor or||
2564|073|S|pharmacist promptly.||
2564|074|S|   Remember that this medication has been prescribed because your||
2564|075|S|doctor has judged that the benefit to you is greater than the||
2564|076|S|risk of side effects. Many people using this medication do not||
2564|077|S|have serious side effects.||
2564|078|S|   A very serious allergic reaction to this drug is rare.||
2564|079|S|However, get medical help right away if you notice any symptoms||
2564|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2564|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2564|082|S|breathing.||
2564|083|S|   This is not a complete list of possible side effects. If you||
2564|084|S|notice other effects not listed above, contact your doctor or||
2564|085|S|pharmacist.||
2564|086|S|   In the US -||
2564|087|S|   Call your doctor for medical advice about side effects. You||
2564|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2564|089|S|www.fda.gov/medwatch.||
2564|090|S|   In Canada - Call your doctor for medical advice about side||
2564|091|S|effects. You may report side effects to Health Canada at||
2564|092|S|1-866-234-2345.||
2564|093|B|||
2564|094|P|PRECAUTIONS:  Before taking iptacopan, tell your doctor or||
2564|095|P|pharmacist if you are allergic to it; or if you have any other||
2564|096|P|allergies. This product may contain inactive ingredients, which||
2564|097|P|can cause allergic reactions or other problems. Talk to your||
2564|098|P|pharmacist for more details.||
2564|099|P|   Before using this medication, tell your doctor or pharmacist||
2564|100|P|your medical history, especially of: current/recent infection,||
2564|101|P|liver disease.||
2564|102|P|   Iptacopan can make you more likely to get certain infections||
2564|103|P|(such as colds, meningitis). Talk to your doctor for more||
2564|104|P|details.||
2564|105|P|   Tell your doctor your vaccine history and ask if you need to||
2564|106|P|get any vaccines before starting treatment with this medication.||
2564|107|P|Tell your health care professional that you are using iptacopan||
2564|108|P|before having any immunizations/vaccinations. Avoid contact with||
2564|109|P|people who have recently received live vaccines (such as flu||
2564|110|P|vaccine inhaled through the nose).||
2564|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2564|112|P|can make you more dizzy. Do not drive, use machinery, or do||
2564|113|P|anything that needs alertness until you can do it safely. Limit||
2564|114|P|alcoholic beverages. Talk to your doctor if you are using||
2564|115|P|marijuana (cannabis).||
2564|116|P|   Before having surgery, tell your doctor or dentist about all||
2564|117|P|the products you use (including prescription drugs,||
2564|118|P|nonprescription drugs, and herbal products).||
2564|119|P|   During pregnancy, this medication should be used only when||
2564|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
2564|121|P|   It is unknown if this medication passes into breast milk.||
2564|122|P|Breastfeeding is not recommended while using this medication and||
2564|123|P|for 5 days after the last dose. Consult your doctor before||
2564|124|P|breastfeeding.||
2564|125|B|||
2564|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2564|127|I|medications work or increase your risk for serious side effects.||
2564|128|I|This document does not contain all possible drug interactions.||
2564|129|I|Keep a list of all the products you use (including||
2564|130|I|prescription/nonprescription drugs and herbal products) and share||
2564|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
2564|132|I|the dosage of any medicines without your doctor's approval.||
2564|133|I|   Other medications can affect the removal of iptacopan from||
2564|134|I|your body, which may affect how iptacopan works. An example of an||
2564|135|I|affected drug is gemfibrozil, among others.||
2564|136|B|||
2564|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2564|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2564|139|O|poison control center right away. US residents can call||
2564|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2564|141|B|||
2564|142|N|NOTES:  Do not share this medication with others.||
2564|143|N|   Lab and/or medical tests (such as complete blood count, blood||
2564|144|N|cholesterol/triglyceride level) should be done while you are||
2564|145|N|taking this medication. Keep all medical and lab appointments.||
2564|146|N|Consult your doctor for more details.||
2564|147|B|||
2564|148|D|MISSED DOSE:  If you miss one or more doses, take one dose as||
2564|149|D|soon as you remember. Then take your next dose at the regular||
2564|150|D|time. Do not double the dose to catch up.||
2564|151|B|||
2564|152|R|STORAGE:  Different brands of this medication have different||
2564|153|R|storage needs. Check the product package for instructions on how||
2564|154|R|to store your brand, or ask your pharmacist. Keep all medications||
2564|155|R|away from children and pets.||
2564|156|R|   Do not flush medications down the toilet or pour them into a||
2564|157|R|drain unless instructed to do so. Properly discard this product||
2564|158|R|when it is expired or no longer needed. Consult your pharmacist||
2564|159|R|or local waste disposal company.||
2564|160|B|||
2564|161|M|MEDICAL ALERT:  Your condition can cause complications in a||
2564|162|M|medical emergency. For information about enrolling in MedicAlert,||
2564|163|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2564|164|B|||
2564|165|A|Information last revised May 2025.||
2564|166|A|Copyright(c) 2025 First Databank, Inc.||
2564|167|B|||
2565|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2565|002|Z|does NOT have all possible information about this product. This||
2565|003|Z|information does not assure that this product is safe, effective,||
2565|004|Z|or appropriate for you. This information is not individual||
2565|005|Z|medical advice and does not substitute for the advice of your||
2565|006|Z|health care professional. Always ask your health care||
2565|007|Z|professional for complete information about this product and your||
2565|008|Z|specific health needs.||
2565|009|B|||
2565|010|T|ZILUCOPLAN - INJECTION||
2565|011|F|(ZIL-ue-KOE-plan)||
2565|012|B|||
2565|013|C|COMMON BRAND NAME(S): Zilbrysq||
2565|014|B|||
2565|015|W|WARNING:  Zilucoplan can lower your body's ability to fight||
2565|016|W|infections. It can increase your chance of getting a very serious||
2565|017|W|(possibly fatal) brain/spinal cord infection (meningitis). Get||
2565|018|W|medical help right away if you develop any signs of a severe||
2565|019|W|infection (including meningitis), such as nausea/vomiting that||
2565|020|W|doesn't stop, high fever, chills, severe headache, stiff neck,||
2565|021|W|mental/mood changes (such as confusion), muscle aches with||
2565|022|W|flu-like symptoms, eye sensitivity to light.||
2565|023|W|   You should get the vaccine for meningitis (meningococcal||
2565|024|W|vaccine) at least 2 weeks before you start zilucoplan. If you||
2565|025|W|have been previously vaccinated for meningitis, ask your doctor||
2565|026|W|if you need to be vaccinated again before using this medication.||
2565|027|W|The vaccine will protect most people, but meningitis may occur||
2565|028|W|even in people who have been vaccinated. You should still watch||
2565|029|W|for signs of meningitis even if you receive the vaccine. Consult||
2565|030|W|your doctor for more details.||
2565|031|W|   To receive zilucoplan in the United States, you must||
2565|032|W|understand, agree to, and carefully follow the requirements of||
2565|033|W|the REMS Program for this medication. If you live in Canada or||
2565|034|W|any other country, consult your doctor and pharmacist for your||
2565|035|W|country's regulations.||
2565|036|B|||
2565|037|U|USES:  Zilucoplan is used to treat a certain muscle condition||
2565|038|U|(generalized myasthenia gravis). It may help to improve symptoms||
2565|039|U|of muscle weakness.||
2565|040|B|||
2565|041|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2565|042|H|provided by your pharmacist before you start using zilucoplan and||
2565|043|H|each time you get a refill. Carry the Patient Safety Card with||
2565|044|H|you at all times during treatment and for 2 months after your||
2565|045|H|last dose of zilucoplan. Ask your health care professional how to||
2565|046|H|prepare and use this medication. If you have any questions, ask||
2565|047|H|your doctor or pharmacist.||
2565|048|H|   Inject this medication under the skin as directed by your||
2565|049|H|doctor, usually once daily. The injection is given in the||
2565|050|H|abdomen, thigh, or upper arm. The dosage is based on your medical||
2565|051|H|condition and weight.||
2565|052|H|   Take the medication out of the refrigerator 30 to 45 minutes||
2565|053|H|before you inject it to allow it to reach room temperature. Do||
2565|054|H|not warm up this medication any other way (for example, do not||
2565|055|H|heat it in the microwave, place it in hot water, or leave it in||
2565|056|H|direct sunlight). Before using, check this product for particles||
2565|057|H|or discoloration. If either is present, do not use the liquid.||
2565|058|H|Before injecting each dose, clean the skin you are going to||
2565|059|H|inject into (the injection site) with rubbing alcohol. Change the||
2565|060|H|injection site each time to lessen injury under the skin. Do not||
2565|061|H|inject into skin that is tender, bruised, red, hard, or has scars||
2565|062|H|or stretch marks. To lessen bruising, do not rub the injection||
2565|063|H|site after a shot. Learn how to store and discard medical||
2565|064|H|supplies safely.||
2565|065|H|   Use this medication regularly to get the most benefit from it.||
2565|066|H|To help you remember, use it at the same time each day.||
2565|067|H|   Do not use this drug more often or for longer than prescribed.||
2565|068|H|Your condition will not improve any faster, and your risk of side||
2565|069|H|effects will increase.||
2565|070|H|   Tell your doctor if your condition does not get better or if||
2565|071|H|it gets worse.||
2565|072|B|||
2565|073|S|SIDE EFFECTS:  See also Warning section.||
2565|074|S|   Pain/swelling/bruising at the injection site or diarrhea may||
2565|075|S|occur. If any of these effects last or get worse, tell your||
2565|076|S|doctor or pharmacist promptly.||
2565|077|S|   Remember that this medication has been prescribed because your||
2565|078|S|doctor has judged that the benefit to you is greater than the||
2565|079|S|risk of side effects. Many people using this medication do not||
2565|080|S|have serious side effects.||
2565|081|S|   Tell your doctor right away if you have any serious side||
2565|082|S|effects, including: signs of infection (such as sore throat that||
2565|083|S|doesn't go away, fever, chills, painful urination),||
2565|084|S|stomach/abdominal pain.||
2565|085|S|   A very serious allergic reaction to this drug is rare.||
2565|086|S|However, get medical help right away if you notice any symptoms||
2565|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2565|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2565|089|S|breathing.||
2565|090|S|   This is not a complete list of possible side effects. If you||
2565|091|S|notice other effects not listed above, contact your doctor or||
2565|092|S|pharmacist.||
2565|093|S|   In the US -||
2565|094|S|   Call your doctor for medical advice about side effects. You||
2565|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2565|096|S|www.fda.gov/medwatch.||
2565|097|S|   In Canada - Call your doctor for medical advice about side||
2565|098|S|effects. You may report side effects to Health Canada at||
2565|099|S|1-866-234-2345.||
2565|100|B|||
2565|101|P|PRECAUTIONS:  Before using zilucoplan, tell your doctor or||
2565|102|P|pharmacist if you are allergic to it; or if you have any other||
2565|103|P|allergies. This product may contain inactive ingredients, which||
2565|104|P|can cause allergic reactions or other problems. Talk to your||
2565|105|P|pharmacist for more details.||
2565|106|P|   Before using this medication, tell your doctor or pharmacist||
2565|107|P|your medical history, especially of: current/recent infection.||
2565|108|P|   Zilucoplan can make you more likely to get certain infections||
2565|109|P|(such as gonorrhea, meningitis). Talk to your doctor for more||
2565|110|P|details.||
2565|111|P|   Tell your doctor your vaccine history and ask if you need to||
2565|112|P|get any vaccines before starting treatment with this medication.||
2565|113|P|Tell your health care professional that you are using zilucoplan||
2565|114|P|before having any immunizations/vaccinations. Avoid contact with||
2565|115|P|people who have recently received live vaccines (such as flu||
2565|116|P|vaccine inhaled through the nose).||
2565|117|P|   Before having surgery, tell your doctor or dentist about all||
2565|118|P|the products you use (including prescription drugs,||
2565|119|P|nonprescription drugs, and herbal products).||
2565|120|P|   During pregnancy, this medication should be used only when||
2565|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
2565|122|P|   It is unknown if this medication passes into breast milk.||
2565|123|P|Consult your doctor before breastfeeding.||
2565|124|B|||
2565|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2565|126|I|medications work or increase your risk for serious side effects.||
2565|127|I|This document does not contain all possible drug interactions.||
2565|128|I|Keep a list of all the products you use (including||
2565|129|I|prescription/nonprescription drugs and herbal products) and share||
2565|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
2565|131|I|the dosage of any medicines without your doctor's approval.||
2565|132|B|||
2565|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2565|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2565|135|O|poison control center right away. US residents can call||
2565|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2565|137|B|||
2565|138|N|NOTES:  Do not share this medication with others.||
2565|139|N|   Lab and/or medical tests (such as amylase/lipase level) should||
2565|140|N|be done before you start using this medication and while you are||
2565|141|N|using it. Keep all medical and lab appointments. Consult your||
2565|142|N|doctor for more details.||
2565|143|B|||
2565|144|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
2565|145|D|on the same day. Use your next dose at the regular time. Do not||
2565|146|D|give more than 1 dose per day to catch up.||
2565|147|B|||
2565|148|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2565|149|R|medication in the original carton to protect from light. This||
2565|150|R|medication may also be stored at room temperature if needed. If||
2565|151|R|the medication is stored at room temperature, do not put it back||
2565|152|R|in the refrigerator and discard after 3 months. Keep all||
2565|153|R|medications away from children and pets.||
2565|154|R|   Do not flush medications down the toilet or pour them into a||
2565|155|R|drain unless instructed to do so. Properly discard this product||
2565|156|R|when it is expired or no longer needed. Consult your pharmacist||
2565|157|R|or local waste disposal company.||
2565|158|B|||
2565|159|M|MEDICAL ALERT:  Your condition can cause complications in a||
2565|160|M|medical emergency. For information about enrolling in MedicAlert,||
2565|161|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2565|162|B|||
2565|163|A|Information last revised April 2025.||
2565|164|A|Copyright(c) 2025 First Databank, Inc.||
2565|165|B|||
2566|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2566|002|Z|does NOT have all possible information about this product. This||
2566|003|Z|information does not assure that this product is safe, effective,||
2566|004|Z|or appropriate for you. This information is not individual||
2566|005|Z|medical advice and does not substitute for the advice of your||
2566|006|Z|health care professional. Always ask your health care||
2566|007|Z|professional for complete information about this product and your||
2566|008|Z|specific health needs.||
2566|009|B|||
2566|010|T|IBUPROFEN/ACETAMINOPHEN - INJECTION||
2566|011|F|(EYE-bue-PROE-fen/a-SEET-a-MIN-oh-fen)||
2566|012|B|||
2566|013|C|COMMON BRAND NAME(S): Combogesic IV||
2566|014|B|||
2566|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
2566|016|W|ibuprofen) may rarely increase the risk for a heart attack or||
2566|017|W|stroke. This effect can happen at any time while using this drug||
2566|018|W|but is more likely if you use it for a long time. The risk may be||
2566|019|W|greater in older adults or if you have heart disease or increased||
2566|020|W|risk for heart disease (for example, due to smoking, family||
2566|021|W|history of heart disease, or conditions such as high blood||
2566|022|W|pressure or diabetes). Do not use this drug right before or after||
2566|023|W|heart bypass surgery (CABG).||
2566|024|W|   One ingredient in this product is acetaminophen. Using too||
2566|025|W|much acetaminophen may cause serious (possibly fatal) liver||
2566|026|W|disease. Adults should not use more than 4000 milligrams (4||
2566|027|W|grams) of acetaminophen a day. People with liver problems should||
2566|028|W|use less acetaminophen. Ask your doctor or pharmacist how much||
2566|029|W|acetaminophen is safe to use.||
2566|030|W|   Do not use with any other drug containing acetaminophen||
2566|031|W|without asking your doctor or pharmacist first. Acetaminophen is||
2566|032|W|in many nonprescription and prescription medications (such as||
2566|033|W|pain/fever drugs or cough-and-cold products). Check the labels on||
2566|034|W|all your medicines to see if they contain acetaminophen, and ask||
2566|035|W|your pharmacist if you are unsure.||
2566|036|W|   Get medical help right away if you use too much acetaminophen||
2566|037|W|(overdose), even if you feel well. Overdose symptoms may include||
2566|038|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
2566|039|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
2566|040|W|   Daily alcohol use, especially when combined with this product,||
2566|041|W|may damage your liver. Daily use of alcohol and tobacco may also||
2566|042|W|increase your risk for stomach bleeding. Avoid alcohol and stop||
2566|043|W|smoking.||
2566|044|W|   This drug may rarely cause serious (rarely fatal) bleeding||
2566|045|W|from the stomach or intestines. This effect can occur without||
2566|046|W|warning at any time while using this drug. Older adults may be at||
2566|047|W|higher risk for this effect.||
2566|048|W|   Stop using this medication and get medical help right away if||
2566|049|W|you notice any of these rare but serious side effects:||
2566|050|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
2566|051|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
2566|052|W|shortness of breath, unusual sweating, confusion, weakness on one||
2566|053|W|side of the body, trouble speaking, sudden vision changes.||
2566|054|W|   Talk to your doctor or pharmacist about the benefits and risks||
2566|055|W|of using this drug.||
2566|056|B|||
2566|057|U|USES:  This medication contains 2 ingredients: ibuprofen and||
2566|058|U|acetaminophen. It is used to relieve mild to moderate pain. When||
2566|059|U|used with an opioid (such as morphine), it may be used to relieve||
2566|060|U|moderate to severe pain. Ibuprofen is a nonsteroidal||
2566|061|U|anti-inflammatory drug (NSAID). This combination product works by||
2566|062|U|blocking your body's production of certain natural substances||
2566|063|U|that cause inflammation. This effect helps to decrease swelling||
2566|064|U|and pain.||
2566|065|B|||
2566|066|H|HOW TO USE:  If you are using this medication at home, learn all||
2566|067|H|preparation and usage instructions from your health care||
2566|068|H|professional.||
2566|069|H|   Before using, check this product for particles or||
2566|070|H|discoloration. If either is present, do not use the liquid.||
2566|071|H|   This medication is given by injection into a vein as directed||
2566|072|H|by your doctor, usually every 6 hours as needed for pain relief.||
2566|073|H|Each dose is usually given over 15 minutes.||
2566|074|H|   Learn how to store and discard medical supplies safely.||
2566|075|H|   The dosage is based on your medical condition, weight, and||
2566|076|H|response to treatment. To reduce your risk of stomach bleeding||
2566|077|H|and other side effects, use the lowest effective dose for the||
2566|078|H|shortest possible time. Do not increase your dose or use it for||
2566|079|H|more than 5 days unless otherwise directed.||
2566|080|H|   If you are using this drug "as needed" (not on a regular||
2566|081|H|schedule), remember that pain medications work best if they are||
2566|082|H|used as the first signs of pain occur. If you wait until the pain||
2566|083|H|has worsened, the medication may not work as well.||
2566|084|H|   Tell your doctor if your pain lasts or gets worse.||
2566|085|B|||
2566|086|S|SIDE EFFECTS:  See also Warning section.||
2566|087|S|   Pain at the injection site may occur. Upset stomach, nausea,||
2566|088|S|vomiting, headache, diarrhea, constipation, dizziness, or||
2566|089|S|drowsiness may also occur. If any of these effects last or get||
2566|090|S|worse, tell your doctor or pharmacist promptly.||
2566|091|S|   Remember that this medication has been prescribed because your||
2566|092|S|doctor has judged that the benefit to you is greater than the||
2566|093|S|risk of side effects. Many people using this medication do not||
2566|094|S|have serious side effects.||
2566|095|S|   This medication may raise your blood pressure. Check your||
2566|096|S|blood pressure regularly and tell your doctor if the results are||
2566|097|S|high.||
2566|098|S|   Tell your doctor right away if you have any serious side||
2566|099|S|effects, including: easy bruising/bleeding, hearing changes (such||
2566|100|S|as ringing in the ears), mental/mood changes, vision changes,||
2566|101|S|unexplained stiff neck, signs of kidney problems (such as change||
2566|102|S|in the amount of urine), symptoms of heart failure (such as||
2566|103|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
2566|104|S|gain).||
2566|105|S|   This product may rarely cause serious (possibly fatal) liver||
2566|106|S|disease. Get medical help right away if you have any symptoms of||
2566|107|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
2566|108|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2566|109|S|urine.||
2566|110|S|   A very serious allergic reaction to this drug is rare.||
2566|111|S|However, get medical help right away if you notice any symptoms||
2566|112|S|of a serious allergic reaction, including: fever, swollen lymph||
2566|113|S|nodes, rash, itching/swelling (especially of the||
2566|114|S|face/tongue/throat), severe dizziness, trouble breathing.||
2566|115|S|   This is not a complete list of possible side effects. If you||
2566|116|S|notice other effects not listed above, contact your doctor or||
2566|117|S|pharmacist.||
2566|118|S|   In the US -||
2566|119|S|   Call your doctor for medical advice about side effects. You||
2566|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2566|121|S|www.fda.gov/medwatch.||
2566|122|S|   In Canada - Call your doctor for medical advice about side||
2566|123|S|effects. You may report side effects to Health Canada at||
2566|124|S|1-866-234-2345.||
2566|125|B|||
2566|126|P|PRECAUTIONS:  See also Warning section.||
2566|127|P|   Before using this medication, tell your doctor or pharmacist||
2566|128|P|if you are allergic to ibuprofen or acetaminophen; or to aspirin||
2566|129|P|or other NSAIDs (such as naproxen, celecoxib); or if you have any||
2566|130|P|other allergies. This product may contain inactive ingredients,||
2566|131|P|which can cause allergic reactions or other problems. Talk to||
2566|132|P|your pharmacist for more details.||
2566|133|P|   Before using this medication, tell your doctor or pharmacist||
2566|134|P|your medical history, especially of: asthma (including a history||
2566|135|P|of worsening breathing after taking aspirin or other NSAIDs),||
2566|136|P|blood disorders (such as anemia, bleeding/clotting problems),||
2566|137|P|growths in the nose (nasal polyps), heart disease (such as||
2566|138|P|previous heart attack), high blood pressure, liver disease,||
2566|139|P|regular use/abuse of alcohol, stroke,||
2566|140|P|stomach/intestinal/esophagus problems (such as bleeding,||
2566|141|P|heartburn, ulcers).||
2566|142|P|   Kidney problems can sometimes occur with the use of NSAID||
2566|143|P|medications, including ibuprofen/acetaminophen. Problems are more||
2566|144|P|likely to occur if you are dehydrated, have heart failure or||
2566|145|P|kidney disease, are an older adult, or if you take certain||
2566|146|P|medications (see also Drug Interactions section). Drink plenty of||
2566|147|P|fluids as directed by your doctor to prevent dehydration and tell||
2566|148|P|your doctor right away if you have any unusual change in the||
2566|149|P|amount of urine.||
2566|150|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2566|151|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2566|152|P|machinery, or do anything that needs alertness until you can do||
2566|153|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2566|154|P|are using marijuana (cannabis).||
2566|155|P|   This medication may make you more sensitive to the sun. Limit||
2566|156|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2566|157|P|sunscreen and wear protective clothing when outdoors. Tell your||
2566|158|P|doctor right away if you get sunburned or have skin||
2566|159|P|blisters/redness.||
2566|160|P|   Before having surgery, tell your doctor or dentist about all||
2566|161|P|the products you use (including prescription drugs,||
2566|162|P|nonprescription drugs, and herbal products).||
2566|163|P|   Older adults may be at greater risk for stomach/intestinal||
2566|164|P|bleeding, kidney problems, heart attack, and stroke while using||
2566|165|P|this drug.||
2566|166|P|   Before using this medication, women of childbearing age should||
2566|167|P|talk with their doctor(s) about the benefits and risks. Tell your||
2566|168|P|doctor if you are pregnant or if you plan to become pregnant.||
2566|169|P|This medication may harm an unborn baby and cause problems with||
2566|170|P|normal labor/delivery. It is not recommended for use in pregnancy||
2566|171|P|from 20 weeks until delivery. If your doctor decides that you||
2566|172|P|need to use this medication between 20 and 30 weeks of pregnancy,||
2566|173|P|you should use the lowest effective dose for the shortest||
2566|174|P|possible time. You should not use this medication after 30 weeks||
2566|175|P|of pregnancy.||
2566|176|P|   This medication passes into breast milk, but is unlikely to||
2566|177|P|harm a nursing infant. Consult your doctor before breastfeeding.||
2566|178|B|||
2566|179|I|DRUG INTERACTIONS:  See also Warning section.||
2566|180|I|   Drug interactions may change how your medications work or||
2566|181|I|increase your risk for serious side effects. This document does||
2566|182|I|not contain all possible drug interactions. Keep a list of all||
2566|183|I|the products you use (including prescription/nonprescription||
2566|184|I|drugs and herbal products) and share it with your doctor and||
2566|185|I|pharmacist. Do not start, stop, or change the dosage of any||
2566|186|I|medicines without your doctor's approval.||
2566|187|I|   Some products that may interact with this drug are: aliskiren,||
2566|188|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
2566|189|I|receptor blockers (such as losartan, valsartan), cidofovir,||
2566|190|I|corticosteroids (such as prednisone), ketoconazole,||
2566|191|I|levoketoconazole, lithium, methotrexate, "water pills" (diuretics||
2566|192|I|such as furosemide).||
2566|193|I|   This medication may increase the risk of bleeding when used||
2566|194|I|with other drugs that also may cause bleeding. Examples include||
2566|195|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2566|196|I|dabigatran/enoxaparin/warfarin, among others.||
2566|197|I|   Check all prescription and nonprescription medicine labels||
2566|198|I|carefully since many medications contain pain relievers/fever||
2566|199|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
2566|200|I|or naproxen). These drugs are similar to ibuprofen and may||
2566|201|I|increase your risk of side effects if used together. However, if||
2566|202|I|your doctor has told you to take low-dose aspirin to prevent||
2566|203|I|heart attack or stroke (usually 81-162 milligrams a day), you||
2566|204|I|should keep taking the aspirin unless your doctor tells you not||
2566|205|I|to. Daily use of ibuprofen may decrease aspirin's ability to||
2566|206|I|prevent heart attack/stroke. Talk to your doctor about using a||
2566|207|I|different medication (such as acetaminophen by itself) to treat||
2566|208|I|pain/fever. If you must use this medication, talk to your doctor||
2566|209|I|about taking immediate-release aspirin (not enteric-coated/EC)||
2566|210|I|while using ibuprofen/acetaminophen. Use this medication at least||
2566|211|I|8 hours before or at least 2 hours after your aspirin dose. Do||
2566|212|I|not increase your daily dose of aspirin or change the way you||
2566|213|I|take aspirin/other medications without your doctor's approval.||
2566|214|I|   This medication may interfere with certain lab tests, possibly||
2566|215|I|causing false test results. Make sure lab personnel and all your||
2566|216|I|doctors know you use this drug.||
2566|217|B|||
2566|218|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2566|219|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2566|220|O|poison control center right away. US residents can call||
2566|221|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2566|222|O|Symptoms of overdose may include: severe stomach pain, trouble||
2566|223|O|breathing, extreme drowsiness.||
2566|224|B|||
2566|225|N|NOTES:  Do not share this medication with others.||
2566|226|N|   Lab and/or medical tests (such as complete blood count,||
2566|227|N|liver/kidney function, blood pressure) may be done while you are||
2566|228|N|using this medication. Keep all medical and lab appointments.||
2566|229|N|   This medication has been prescribed for your current condition||
2566|230|N|only. Do not use it later for another condition unless your||
2566|231|N|doctor tells you to. A different medication may be necessary in||
2566|232|N|those cases.||
2566|233|B|||
2566|234|D|MISSED DOSE:  Not applicable.||
2566|235|B|||
2566|236|R|STORAGE:  Store at room temperature away from heat. Do not||
2566|237|R|refrigerate or freeze. Keep the medication in the original carton||
2566|238|R|to protect from light. Keep all medications away from children||
2566|239|R|and pets.||
2566|240|R|   Do not flush medications down the toilet or pour them into a||
2566|241|R|drain unless instructed to do so. Properly discard this product||
2566|242|R|when it is expired or no longer needed. Consult your pharmacist||
2566|243|R|or local waste disposal company.||
2566|244|B|||
2566|245|A|Information last revised November 2025.||
2566|246|A|Copyright(c) 2025 First Databank, Inc.||
2566|247|B|||
2567|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2567|002|Z|does NOT have all possible information about this product. This||
2567|003|Z|information does not assure that this product is safe, effective,||
2567|004|Z|or appropriate for you. This information is not individual||
2567|005|Z|medical advice and does not substitute for the advice of your||
2567|006|Z|health care professional. Always ask your health care||
2567|007|Z|professional for complete information about this product and your||
2567|008|Z|specific health needs.||
2567|009|B|||
2567|010|T|TAUROLIDINE/HEPARIN LOCK - INJECTION||
2567|011|B|||
2567|012|C|COMMON BRAND NAME(S): Defencath||
2567|013|B|||
2567|014|U|USES:  This combination medication is used to prevent blood||
2567|015|U|infections caused by a tube (catheter) that is placed into a vein||
2567|016|U|for dialysis. Taurolidine is an antimicrobial that decreases the||
2567|017|U|amount of bacteria and fungus inside the catheter. Heparin is||
2567|018|U|known as an anticoagulant. It helps keep blood flowing smoothly||
2567|019|U|and from clotting in the catheter by making a certain natural||
2567|020|U|substance in your body (anti-clotting protein) work better.||
2567|021|U|   This form of heparin must not be used to treat or prevent||
2567|022|U|blood clots in the body.||
2567|023|B|||
2567|024|H|HOW TO USE:  This medication is given by injection into the||
2567|025|H|dialysis catheter, as directed by your doctor, usually at the end||
2567|026|H|of each dialysis treatment. Do not inject this medication into||
2567|027|H|the body. It will be taken out of the catheter and thrown away||
2567|028|H|before the next dialysis treatment.||
2567|029|H|   If you are using this medication at home, learn all||
2567|030|H|preparation and usage instructions from your health care||
2567|031|H|professional. Before using, check this product for particles or||
2567|032|H|discoloration. If either is present, do not use the liquid. Learn||
2567|033|H|how to store and discard medical supplies safely.||
2567|034|H|   Heparin comes in many strengths. Serious (sometimes fatal)||
2567|035|H|injuries have occurred when the wrong strength was used. Check||
2567|036|H|that you are using the correct strength and dose before injecting||
2567|037|H|this medication into the dialysis catheter.||
2567|038|B|||
2567|039|S|SIDE EFFECTS:  The dialysis catheter may not work properly after||
2567|040|S|this medication is used. If this effect lasts or gets worse, tell||
2567|041|S|your doctor or pharmacist promptly.||
2567|042|S|   Remember that this medication has been prescribed because your||
2567|043|S|doctor has judged that the benefit to you is greater than the||
2567|044|S|risk of side effects. Many people using this medication do not||
2567|045|S|have serious side effects.||
2567|046|S|   Although very unlikely, this medication can cause bleeding if||
2567|047|S|its effect on your clotting proteins is too much. Tell your||
2567|048|S|doctor right away if you develop any signs of serious bleeding,||
2567|049|S|including unusual pain/swelling/discomfort, prolonged bleeding||
2567|050|S|from cuts or gums, frequent nosebleeds, unusually heavy/prolonged||
2567|051|S|menstrual periods, unusual/easy bruising, dark urine, black||
2567|052|S|stools, severe headache, unusual dizziness.||
2567|053|S|   Heparin may rarely cause certain serious (rarely fatal)||
2567|054|S|clotting problems (heparin-induced thrombocytopenia-HIT or||
2567|055|S|heparin-induced thrombocytopenia and thrombosis-HITT). This can||
2567|056|S|occur during treatment and up to several weeks after treatment||
2567|057|S|with heparin has stopped. You should not use heparin again if you||
2567|058|S|have HIT or HITT. If you notice any of the following very serious||
2567|059|S|side effects, get medical help right away: pain/loss of feeling||
2567|060|S|in the arms/legs, change in color of the arms/legs, chest pain,||
2567|061|S|trouble breathing, confusion, weakness on one side of the body,||
2567|062|S|trouble speaking, vision changes.||
2567|063|S|   A very serious allergic reaction to this drug is rare.||
2567|064|S|However, get medical help right away if you notice any symptoms||
2567|065|S|of a serious allergic reaction, including: fever, chills, rash,||
2567|066|S|itching/swelling (especially of the face/tongue/throat), severe||
2567|067|S|dizziness, trouble breathing.||
2567|068|S|   This is not a complete list of possible side effects. If you||
2567|069|S|notice other effects not listed above, contact your doctor or||
2567|070|S|pharmacist.||
2567|071|S|   In the US -||
2567|072|S|   Call your doctor for medical advice about side effects. You||
2567|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2567|074|S|www.fda.gov/medwatch.||
2567|075|S|   In Canada - Call your doctor for medical advice about side||
2567|076|S|effects. You may report side effects to Health Canada at||
2567|077|S|1-866-234-2345.||
2567|078|B|||
2567|079|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2567|080|P|pharmacist if you are allergic to taurolidine or heparin; or to||
2567|081|P|pork products; or if you have any other allergies. This product||
2567|082|P|may contain inactive ingredients, which can cause allergic||
2567|083|P|reactions or other problems. Talk to your pharmacist for more||
2567|084|P|details.||
2567|085|P|   Before using this medication, tell your doctor or pharmacist||
2567|086|P|your medical history.||
2567|087|P|   Before having surgery, tell your doctor or dentist about all||
2567|088|P|the products you use (including prescription drugs,||
2567|089|P|nonprescription drugs, and herbal products).||
2567|090|P|   Tell your doctor if you are pregnant before using this||
2567|091|P|medication.||
2567|092|P|   Heparin does not pass into breast milk. It is unknown if||
2567|093|P|taurolidine passes into breast milk. Consult your doctor before||
2567|094|P|breastfeeding.||
2567|095|B|||
2567|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2567|097|I|medications work or increase your risk for serious side effects.||
2567|098|I|This document does not contain all possible drug interactions.||
2567|099|I|Keep a list of all the products you use (including||
2567|100|I|prescription/nonprescription drugs and herbal products) and share||
2567|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
2567|102|I|the dosage of any medicines without your doctor's approval.||
2567|103|I|   This medication may interfere with certain lab tests (such as||
2567|104|I|prothrombin time), possibly causing false test results. Make sure||
2567|105|I|lab personnel and all your doctors know you use this drug.||
2567|106|B|||
2567|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2567|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2567|109|O|poison control center right away. US residents can call||
2567|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2567|111|O|Symptoms of overdose may include: easy/unusual bruising,||
2567|112|O|easy/unusual bleeding (such as frequent nosebleeds), blood in||
2567|113|O|urine, black stools.||
2567|114|B|||
2567|115|N|NOTES:  Do not share this medication with others.||
2567|116|B|||
2567|117|D|MISSED DOSE:  Not applicable.||
2567|118|B|||
2567|119|R|STORAGE:  Store in the original carton at room temperature. Do||
2567|120|R|not freeze. Keep all medications away from children and pets.||
2567|121|R|   Do not flush medications down the toilet or pour them into a||
2567|122|R|drain unless instructed to do so. Properly discard this product||
2567|123|R|when it is expired or no longer needed. Consult your pharmacist||
2567|124|R|or local waste disposal company.||
2567|125|B|||
2567|126|A|Information last revised December 2024.||
2567|127|A|Copyright(c) 2025 First Databank, Inc.||
2567|128|B|||
2568|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2568|002|Z|does NOT have all possible information about this product. This||
2568|003|Z|information does not assure that this product is safe, effective,||
2568|004|Z|or appropriate for you. This information is not individual||
2568|005|Z|medical advice and does not substitute for the advice of your||
2568|006|Z|health care professional. Always ask your health care||
2568|007|Z|professional for complete information about this product and your||
2568|008|Z|specific health needs.||
2568|009|B|||
2568|010|T|VOSORITIDE - SUBCUTANEOUS INJECTION||
2568|011|F|(voe-SOR-i-tide)||
2568|012|B|||
2568|013|C|COMMON BRAND NAME(S): Voxzogo||
2568|014|B|||
2568|015|U|USES:  This medication is used to treat children with||
2568|016|U|achondroplasia. Achondroplasia is a condition that affects bone||
2568|017|U|growth, making them shorter than usual, especially the arms and||
2568|018|U|legs. Vosoritide works by promoting bone growth in children who||
2568|019|U|are still growing.||
2568|020|B|||
2568|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2568|022|H|Instructions for Use if available from your pharmacist when you||
2568|023|H|get this medication and each time you get a refill. Ask your||
2568|024|H|health care professional how to prepare and use this medication.||
2568|025|H|If you have any questions, ask your doctor or pharmacist.||
2568|026|H|   Inject this medication under the skin as directed by your||
2568|027|H|doctor, usually once daily. The injection is given in the thigh,||
2568|028|H|buttock, upper arm, or abdomen (except for a 2-inch area around||
2568|029|H|your belly button). The dosage is based on your medical||
2568|030|H|condition, weight, and response to treatment. Monitor your||
2568|031|H|child's weight and growth periodically. Tell your doctor about||
2568|032|H|any weight changes. Your doctor will need to adjust the dose||
2568|033|H|based on the weight change.||
2568|034|H|   Before mixing the medication, take it out of the refrigerator||
2568|035|H|to allow it to reach room temperature. Do not warm up this||
2568|036|H|medication any other way (for example, do not heat it in the||
2568|037|H|microwave or place it in hot water). Do not shake the medication.||
2568|038|H|Before using, check this product for particles or discoloration.||
2568|039|H|If either is present, do not use the liquid. Before injecting||
2568|040|H|each dose, clean the skin you are going to inject into (the||
2568|041|H|injection site) with rubbing alcohol. Change the injection site||
2568|042|H|each time to lessen injury under the skin. Do not inject into||
2568|043|H|skin that is red, swollen, or tender. To lessen bruising, do not||
2568|044|H|rub the injection site after a shot. Learn how to store and||
2568|045|H|discard medical supplies safely.||
2568|046|H|   To reduce the risk of low blood pressure, your child should||
2568|047|H|eat a meal and drink 8 to 10 ounces (240 to 300 milliliters) of||
2568|048|H|fluids (such as water, milk, or juice) within 1 hour before||
2568|049|H|injecting this medication. Tell your doctor right away if your||
2568|050|H|child has symptoms of low blood pressure including dizziness,||
2568|051|H|tiredness, or nausea.||
2568|052|H|   Use this medication regularly to get the most benefit from it.||
2568|053|H|To help you remember, use it at the same time each day.||
2568|054|B|||
2568|055|S|SIDE EFFECTS:  See also How to Use section.||
2568|056|S|   Joint pain, diarrhea, ear pain, flu-like symptoms (such as||
2568|057|S|sore throat, cough, body aches), dry skin, or||
2568|058|S|redness/swelling/bruising/pain at the injection site may occur.||
2568|059|S|If any of these effects last or get worse, tell your doctor or||
2568|060|S|pharmacist promptly.||
2568|061|S|   Remember that this medication has been prescribed because your||
2568|062|S|doctor has judged that the benefit to you is greater than the||
2568|063|S|risk of side effects. Many people using this medication do not||
2568|064|S|have serious side effects.||
2568|065|S|   This medication may cause low blood pressure. Tell your doctor||
2568|066|S|right away if any of these serious side effects occur: dizziness,||
2568|067|S|tiredness, nausea.||
2568|068|S|   A very serious allergic reaction to this drug is rare.||
2568|069|S|However, get medical help right away if you notice any symptoms||
2568|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2568|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2568|072|S|breathing.||
2568|073|S|   This is not a complete list of possible side effects. If you||
2568|074|S|notice other effects not listed above, contact your doctor or||
2568|075|S|pharmacist.||
2568|076|S|   In the US -||
2568|077|S|   Call your doctor for medical advice about side effects. You||
2568|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2568|079|S|www.fda.gov/medwatch.||
2568|080|S|   In Canada - Call your doctor for medical advice about side||
2568|081|S|effects. You may report side effects to Health Canada at||
2568|082|S|1-866-234-2345.||
2568|083|B|||
2568|084|P|PRECAUTIONS:  Before using vosoritide, tell your doctor or||
2568|085|P|pharmacist if you are allergic to it; or if you have any other||
2568|086|P|allergies. This product may contain inactive ingredients, which||
2568|087|P|can cause allergic reactions or other problems. Talk to your||
2568|088|P|pharmacist for more details.||
2568|089|P|   Before using this medication, tell your doctor or pharmacist||
2568|090|P|your child's medical history, especially of: child's bones no||
2568|091|P|longer growing (closed growth plates).||
2568|092|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2568|093|P|can make you more dizzy. Do not drive, use machinery, or do||
2568|094|P|anything that needs alertness until you can do it safely. Limit||
2568|095|P|alcoholic beverages. Talk to your doctor if you are using||
2568|096|P|marijuana (cannabis).||
2568|097|P|   Before having surgery, tell your doctor or dentist about all||
2568|098|P|the products you use (including prescription drugs,||
2568|099|P|nonprescription drugs, and herbal products).||
2568|100|P|   During pregnancy, this medication should be used only when||
2568|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
2568|102|P|   It is unknown if this medication passes into breast milk.||
2568|103|P|Consult your doctor before breastfeeding.||
2568|104|B|||
2568|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2568|106|I|medications work or increase your risk for serious side effects.||
2568|107|I|This document does not contain all possible drug interactions.||
2568|108|I|Keep a list of all the products you use (including||
2568|109|I|prescription/nonprescription drugs and herbal products) and share||
2568|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
2568|111|I|the dosage of any medicines without your doctor's approval.||
2568|112|B|||
2568|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2568|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2568|115|O|poison control center right away. US residents can call||
2568|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2568|117|B|||
2568|118|N|NOTES:  Do not share this medication with others.||
2568|119|N|   Lab tests (such as alkaline phosphatase levels) should be done||
2568|120|N|while you are using this medication. Keep all medical and lab||
2568|121|N|appointments. Consult your doctor for more details.||
2568|122|B|||
2568|123|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2568|124|D|If it is more than 12 hours after the missed dose, skip the||
2568|125|D|missed dose. Use your next dose at the regular time on the next||
2568|126|D|day. Do not double the dose to catch up.||
2568|127|B|||
2568|128|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2568|129|R|medication in the original carton to protect from light. This||
2568|130|R|medication may also be stored at room temperature if needed. If||
2568|131|R|the medication is stored at room temperature, do not put it back||
2568|132|R|in the refrigerator and discard after 90 days. Discard any unused||
2568|133|R|portion after use. Keep all medications away from children and||
2568|134|R|pets.||
2568|135|R|   Do not flush medications down the toilet or pour them into a||
2568|136|R|drain unless instructed to do so. Properly discard this product||
2568|137|R|when it is expired or no longer needed. Consult your pharmacist||
2568|138|R|or local waste disposal company.||
2568|139|B|||
2568|140|A|Information last revised October 2024.||
2568|141|A|Copyright(c) 2025 First Databank, Inc.||
2568|142|B|||
2569|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2569|002|Z|does NOT have all possible information about this product. This||
2569|003|Z|information does not assure that this product is safe, effective,||
2569|004|Z|or appropriate for you. This information is not individual||
2569|005|Z|medical advice and does not substitute for the advice of your||
2569|006|Z|health care professional. Always ask your health care||
2569|007|Z|professional for complete information about this product and your||
2569|008|Z|specific health needs.||
2569|009|B|||
2569|010|T|BUDESONIDE SUSPENSION PACKET - ORAL||
2569|011|F|(bue-DES-oh-nide)||
2569|012|B|||
2569|013|C|COMMON BRAND NAME(S): Eohilia||
2569|014|B|||
2569|015|U|USES:  This medication is used to treat a certain immune disorder||
2569|016|U|of the esophagus (eosinophilic esophagitis-EoE). The esophagus is||
2569|017|U|the tube that connects your mouth to your stomach. In EoE, a type||
2569|018|U|of white blood cell builds up in the esophagus and causes damage||
2569|019|U|that can lead to symptoms such as trouble swallowing, food||
2569|020|U|getting stuck when you swallow, chest discomfort, and backflow of||
2569|021|U|undigested food (regurgitation). Budesonide is an||
2569|022|U|anti-inflammatory drug (corticosteroid hormone). It works by||
2569|023|U|decreasing the body's natural defense response (immune response).||
2569|024|B|||
2569|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
2569|026|H|Instructions for Use if available from your pharmacist before you||
2569|027|H|start taking budesonide and each time you get a refill. If you||
2569|028|H|have any questions, ask your doctor or pharmacist.||
2569|029|H|   Take this medication by mouth as directed by your doctor,||
2569|030|H|usually twice daily (once in the morning and once in the||
2569|031|H|evening). Do not take with liquid or food.||
2569|032|H|   Shake the suspension packet well for at least 10 seconds||
2569|033|H|before opening. Open the packet with scissors and squeeze the||
2569|034|H|medication into your mouth as directed and swallow. Repeat 2 to 3||
2569|035|H|times until the packet is empty. To make sure this medication||
2569|036|H|works properly, do not eat or drink for at least 30 minutes after||
2569|037|H|you have taken it. After 30 minutes, rinse your mouth with water||
2569|038|H|and spit without swallowing.||
2569|039|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2569|040|H|using this medication unless your doctor or pharmacist says you||
2569|041|H|may do so safely. Grapefruit can increase the chance of side||
2569|042|H|effects with this medicine. Ask your doctor or pharmacist for||
2569|043|H|more details.||
2569|044|H|   If you are regularly using a different corticosteroid taken by||
2569|045|H|mouth (such as prednisone), you should not stop using it unless||
2569|046|H|directed by your doctor. You may have withdrawal symptoms if the||
2569|047|H|drug is suddenly stopped. Some conditions (such as asthma,||
2569|048|H|allergies) may become worse when the drug is suddenly stopped. To||
2569|049|H|prevent withdrawal symptoms (such as weakness, weight loss,||
2569|050|H|nausea, muscle pain, headache, tiredness, dizziness), your doctor||
2569|051|H|may direct you to slowly lower the dose of your old medication||
2569|052|H|after you begin using this product. Consult your doctor or||
2569|053|H|pharmacist for more details, and report any withdrawal reactions||
2569|054|H|right away. See also Precautions section.||
2569|055|H|   Use this medication regularly to get the most benefit from it.||
2569|056|H|To help you remember, take it at the same times each day. Do not||
2569|057|H|increase your dose or use this drug more often or for longer than||
2569|058|H|prescribed. Your condition will not improve any faster, and your||
2569|059|H|risk of side effects will increase.||
2569|060|H|   Do not stop taking this medication without consulting your||
2569|061|H|doctor. Some conditions may become worse when this drug is||
2569|062|H|suddenly stopped. Your dose may need to be gradually decreased.||
2569|063|H|   Tell your doctor if your condition lasts or gets worse.||
2569|064|B|||
2569|065|S|SIDE EFFECTS:  Tiredness and headache may occur. If either of||
2569|066|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2569|067|S|promptly.||
2569|068|S|   Remember that this medication has been prescribed because your||
2569|069|S|doctor has judged that the benefit to you is greater than the||
2569|070|S|risk of side effects. Many people using this medication do not||
2569|071|S|have serious side effects.||
2569|072|S|   Because this drug works by weakening the immune system, it may||
2569|073|S|lower your ability to fight infections. This may make you more||
2569|074|S|likely to get a serious (rarely fatal) infection or make any||
2569|075|S|infection you have worse. Tell your doctor right away if you have||
2569|076|S|any signs of infection (such as sore throat that doesn't go away,||
2569|077|S|fever, chills).||
2569|078|S|   This medication may sometimes cause oral thrush or a new yeast||
2569|079|S|infection. Contact your doctor if you notice white patches in||
2569|080|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2569|081|S|   Tell your doctor right away if you have any serious side||
2569|082|S|effects, including: weakness, easy bruising/bleeding, puffy face,||
2569|083|S|unusual weight gain, menstrual period changes, mental/mood||
2569|084|S|changes (such as depression, mood swings, agitation), muscle||
2569|085|S|weakness/pain, bone pain, thinning skin, slow wound healing,||
2569|086|S|increased thirst/urination, vision problems, symptoms of||
2569|087|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
2569|088|S|black/tarry stools, vomit that looks like coffee grounds),||
2569|089|S|red/purple spots on the skin.||
2569|090|S|   A very serious allergic reaction to this drug is rare.||
2569|091|S|However, get medical help right away if you notice any symptoms||
2569|092|S|of a serious allergic reaction, including: rash, itching/swelling||
2569|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2569|094|S|breathing.||
2569|095|S|   This is not a complete list of possible side effects. If you||
2569|096|S|notice other effects not listed above, contact your doctor or||
2569|097|S|pharmacist.||
2569|098|S|   In the US -||
2569|099|S|   Call your doctor for medical advice about side effects. You||
2569|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2569|101|S|www.fda.gov/medwatch.||
2569|102|S|   In Canada - Call your doctor for medical advice about side||
2569|103|S|effects. You may report side effects to Health Canada at||
2569|104|S|1-866-234-2345.||
2569|105|B|||
2569|106|P|PRECAUTIONS:  Before taking budesonide, tell your doctor if you||
2569|107|P|are allergic to it; or if you have any other allergies. This||
2569|108|P|product may contain inactive ingredients, which can cause||
2569|109|P|allergic reactions or other problems. Talk to your pharmacist for||
2569|110|P|more details.||
2569|111|P|   Before using this medication, tell your doctor or pharmacist||
2569|112|P|your medical history, especially of: eye problems (such as||
2569|113|P|cataracts, glaucoma, herpes infection of the eye), high blood||
2569|114|P|pressure, liver problems (such as hepatitis B), diabetes,||
2569|115|P|stomach/intestinal problems (such as diverticulitis, ulcer), bone||
2569|116|P|loss (osteoporosis), current/past infections (such as those||
2569|117|P|caused by tuberculosis, herpes, threadworm, fungus), bleeding||
2569|118|P|problems, mental/mood problems (such as psychosis, anxiety,||
2569|119|P|depression), a certain adrenal gland tumor (pheochromocytoma).||
2569|120|P|   Using corticosteroid medications for a long time can make it||
2569|121|P|more difficult for your body to respond to physical stress.||
2569|122|P|Before having surgery or emergency treatment, or if you get a||
2569|123|P|serious illness/injury, tell your doctor or dentist that you are||
2569|124|P|using this medication or have used this medication within the||
2569|125|P|past 12 months. Tell your doctor right away if you develop||
2569|126|P|unusual/extreme tiredness or weight loss. If you will be using||
2569|127|P|this medication for a long time, carry a warning card or medical||
2569|128|P|ID bracelet that identifies your use of this medication.||
2569|129|P|   Before having surgery, tell your doctor or dentist about all||
2569|130|P|the products you use (including prescription drugs,||
2569|131|P|nonprescription drugs, and herbal products).||
2569|132|P|   This medication may cause stomach bleeding. Daily use of||
2569|133|P|alcohol while using this medication may increase your risk for||
2569|134|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
2569|135|P|or pharmacist for more information.||
2569|136|P|   This medication can make you more likely to get infections or||
2569|137|P|may make current infections worse. Stay away from anyone who has||
2569|138|P|an infection that may easily spread (such as chickenpox,||
2569|139|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2569|140|P|exposed to an infection or for more details.||
2569|141|P|   Tell your health care professional that you are using||
2569|142|P|budesonide before having any immunizations/vaccinations. Avoid||
2569|143|P|contact with people who have recently received live vaccines||
2569|144|P|(such as flu vaccine inhaled through the nose).||
2569|145|P|   Older adults may be more sensitive to the side effects of this||
2569|146|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
2569|147|P|mental/mood changes (such as confusion).||
2569|148|P|   This medication may slow down a child's growth if used for a||
2569|149|P|long time. Consult the doctor or pharmacist for more details. See||
2569|150|P|the doctor regularly so your child's height and growth can be||
2569|151|P|checked.||
2569|152|P|   During pregnancy, this medication should be used only when||
2569|153|P|clearly needed. Discuss the risks and benefits with your doctor.||
2569|154|P|Babies born to mothers who have used corticosteroids for a long||
2569|155|P|time may develop hormone problems. Tell your doctor right away if||
2569|156|P|you notice symptoms such as nausea/vomiting that doesn't stop,||
2569|157|P|severe diarrhea, or weakness in your newborn.||
2569|158|P|   This medication passes into breast milk. Consult your doctor||
2569|159|P|before breastfeeding.||
2569|160|B|||
2569|161|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2569|162|I|medications work or increase your risk for serious side effects.||
2569|163|I|This document does not contain all possible drug interactions.||
2569|164|I|Keep a list of all the products you use (including||
2569|165|I|prescription/nonprescription drugs and herbal products) and share||
2569|166|I|it with your doctor and pharmacist. Do not start, stop, or change||
2569|167|I|the dosage of any medicines without your doctor's approval.||
2569|168|I|   Some products that may interact with this drug are:||
2569|169|I|aldesleukin, desmopressin, mifepristone, drugs that can cause||
2569|170|I|bleeding/bruising (including antiplatelet drugs such as||
2569|171|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
2569|172|I|such as warfarin/dabigatran).||
2569|173|I|   If your doctor has told you to take low-dose aspirin to||
2569|174|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
2569|175|I|you should keep taking the aspirin unless your doctor tells you||
2569|176|I|not to. Ask your doctor or pharmacist for more details.||
2569|177|I|   This product may interfere with certain lab tests (such as||
2569|178|I|skin tests), possibly causing false test results. Make sure lab||
2569|179|I|personnel and all your doctors know you use this drug.||
2569|180|B|||
2569|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2569|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2569|183|O|poison control center right away. US residents can call||
2569|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2569|185|B|||
2569|186|N|NOTES:  Do not share this medication with others.||
2569|187|N|   Lab and/or medical tests (such as blood count, bone density,||
2569|188|N|eye exams, height/weight measurements) may be done while you are||
2569|189|N|taking this medication. Keep all medical and lab appointments.||
2569|190|N|Consult your doctor for more details.||
2569|191|N|   This medication may cause bone loss (osteoporosis) when used||
2569|192|N|for a long time. Lifestyle changes that may help reduce the risk||
2569|193|N|of bone problems include doing weight-bearing exercise, stopping||
2569|194|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2569|195|N|D. Talk to your doctor for more details.||
2569|196|B|||
2569|197|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2569|198|D|remember. If it is near the time of the next dose, skip the||
2569|199|D|missed dose. Take your next dose at the regular time. Do not||
2569|200|D|double the dose to catch up.||
2569|201|B|||
2569|202|R|STORAGE:  Store at room temperature or in the refrigerator. Do||
2569|203|R|not freeze. Keep all medications away from children and pets.||
2569|204|R|   Do not flush medications down the toilet or pour them into a||
2569|205|R|drain unless instructed to do so. Properly discard this product||
2569|206|R|when it is expired or no longer needed. Consult your pharmacist||
2569|207|R|or local waste disposal company.||
2569|208|B|||
2569|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
2569|210|M|medical emergency. For information about enrolling in MedicAlert,||
2569|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2569|212|B|||
2569|213|A|Information last revised September 2025.||
2569|214|A|Copyright(c) 2025 First Databank, Inc.||
2569|215|B|||
2570|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2570|002|Z|does NOT have all possible information about this product. This||
2570|003|Z|information does not assure that this product is safe, effective,||
2570|004|Z|or appropriate for you. This information is not individual||
2570|005|Z|medical advice and does not substitute for the advice of your||
2570|006|Z|health care professional. Always ask your health care||
2570|007|Z|professional for complete information about this product and your||
2570|008|Z|specific health needs.||
2570|009|B|||
2570|010|T|LIFILEUCEL - INJECTION||
2570|011|F|(LIF-i-LOO-sel)||
2570|012|B|||
2570|013|C|COMMON BRAND NAME(S): Amtagvi||
2570|014|B|||
2570|015|W|WARNING:  Lifileucel may cause serious (rarely fatal) problems in||
2570|016|W|the heart, lungs, or kidneys. This product may also cause a||
2570|017|W|severe decrease in your blood cells. This effect can cause||
2570|018|W|anemia, decrease your body's ability to fight an infection, or||
2570|019|W|cause easy bruising/bleeding. You may be more likely to get a||
2570|020|W|serious (rarely fatal) infection or have a bleeding problem. To||
2570|021|W|decrease the risk of side effects, your doctor may direct you to||
2570|022|W|use another medication to help your body make more blood cells.||
2570|023|W|You will also be given this product in a hospital so your doctor||
2570|024|W|can watch for serious side effects and quickly provide treatment||
2570|025|W|if needed. See also Side Effects section.||
2570|026|B|||
2570|027|U|USES:  Lifileucel is used to treat a certain type of skin cancer||
2570|028|U|(melanoma) that has not gotten better or that has come back after||
2570|029|U|other kinds of treatment. Lifileucel is made from your own white||
2570|030|U|blood cells found in your tumor and is given only to you. The||
2570|031|U|white blood cells help your body slow or stop the growth of||
2570|032|U|certain cancer cells.||
2570|033|B|||
2570|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2570|035|H|from your health care professional before you receive lifileucel.||
2570|036|H|If you have any questions, ask your health care professional.||
2570|037|H|   Your doctor will give you 7 days of chemotherapy before||
2570|038|H|treatment with lifileucel to prepare your body. After receiving||
2570|039|H|lifileucel, you will be given another medication to help||
2570|040|H|lifileucel work better.||
2570|041|H|   This product is given by slow injection into a vein as||
2570|042|H|directed by your doctor. Infusion reactions may happen during the||
2570|043|H|infusion of this drug. Your doctor may prescribe other||
2570|044|H|medications (such as acetaminophen, diphenhydramine) before||
2570|045|H|treatment to help prevent these side effects. Tell your doctor||
2570|046|H|right away if you have any symptoms of infusion reactions such as||
2570|047|H|shortness of breath, fever, chills, fast heartbeat, rash, or||
2570|048|H|dizziness.||
2570|049|H|   Your doctor will check you daily after your treatment to see||
2570|050|H|how well it works and help you manage any side effects. You||
2570|051|H|should plan to stay for several weeks near the place of your||
2570|052|H|treatment (for example, within 2 hours' drive).||
2570|053|B|||
2570|054|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2570|055|S|   Diarrhea, tiredness, or hair loss may occur. If any of these||
2570|056|S|effects last or get worse, tell your doctor or pharmacist||
2570|057|S|promptly.||
2570|058|S|   People using this medication may have serious side effects.||
2570|059|S|However, you have been prescribed this drug because your doctor||
2570|060|S|has judged that the benefit to you is greater than the risk of||
2570|061|S|side effects. Careful monitoring by your doctor may decrease your||
2570|062|S|risk.||
2570|063|S|   Tell your doctor right away if you have any serious side||
2570|064|S|effects, including: signs of infection (such as sore throat that||
2570|065|S|doesn't go away, fever, chills, cough), easy bruising/bleeding,||
2570|066|S|pale skin, unusual tiredness, signs of kidney problems (such as||
2570|067|S|change in the amount of urine), fast/irregular heartbeat,||
2570|068|S|swelling ankles/feet, sudden unexplained weight gain.||
2570|069|S|   Get medical help right away if you have any very serious side||
2570|070|S|effects, including: signs of stomach/intestinal bleeding (such as||
2570|071|S|bloody/black/tarry stools, vomit that looks like coffee grounds),||
2570|072|S|signs of bleeding in the brain (such as sudden vision changes,||
2570|073|S|dizziness/fainting, confusion), symptoms of a heart attack (such||
2570|074|S|as chest/jaw/left arm pain, shortness of breath, unusual||
2570|075|S|sweating).||
2570|076|S|   A very serious allergic reaction to this drug is rare.||
2570|077|S|However, get medical help right away if you notice any symptoms||
2570|078|S|of a serious allergic reaction, including: rash, itching/swelling||
2570|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2570|080|S|breathing.||
2570|081|S|   This is not a complete list of possible side effects. If you||
2570|082|S|notice other effects not listed above, contact your doctor or||
2570|083|S|pharmacist.||
2570|084|S|   In the US -||
2570|085|S|   Call your doctor for medical advice about side effects. You||
2570|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2570|087|S|www.fda.gov/medwatch.||
2570|088|S|   In Canada - Call your doctor for medical advice about side||
2570|089|S|effects. You may report side effects to Health Canada at||
2570|090|S|1-866-234-2345.||
2570|091|B|||
2570|092|P|PRECAUTIONS:  Before receiving lifileucel, tell your doctor or||
2570|093|P|pharmacist if you have any allergies. This product may contain||
2570|094|P|inactive ingredients, which can cause allergic reactions or other||
2570|095|P|problems. Talk to your pharmacist for more details.||
2570|096|P|   Before using this product, tell your doctor or pharmacist your||
2570|097|P|medical history, especially of: heart problems, kidney problems,||
2570|098|P|liver problems, lung problems, past/current/recent infections.||
2570|099|P|   This product can make you more likely to get infections or may||
2570|100|P|make current infections worse. Stay away from anyone who has an||
2570|101|P|infection that may easily spread (such as chickenpox, COVID-19,||
2570|102|P|measles, flu). Talk to your doctor if you have been exposed to an||
2570|103|P|infection or for more details.||
2570|104|P|   Tell your health care professional that you are using||
2570|105|P|lifileucel before having any immunizations/vaccinations. Avoid||
2570|106|P|contact with people who have recently received live vaccines||
2570|107|P|(such as flu vaccine inhaled through the nose).||
2570|108|P|   To lower the chance of getting cut, bruised, or injured, use||
2570|109|P|caution with sharp objects like razors and nail cutters, and||
2570|110|P|avoid activities such as contact sports.||
2570|111|P|   This drug may make you dizzy or make it harder for you to||
2570|112|P|think clearly. Alcohol or marijuana (cannabis) can make you more||
2570|113|P|dizzy. Do not drive, use machinery, or do anything that needs||
2570|114|P|alertness until you can do it safely (at least 3 weeks after||
2570|115|P|receiving treatment is recommended by some manufacturers). Limit||
2570|116|P|alcoholic beverages. Talk to your doctor if you are using||
2570|117|P|marijuana (cannabis).||
2570|118|P|   Before having surgery, tell your doctor or dentist about all||
2570|119|P|the products you use (including prescription drugs,||
2570|120|P|nonprescription drugs, and herbal products).||
2570|121|P|   Tell your doctor if you are pregnant or plan to become||
2570|122|P|pregnant. You should not become pregnant while using lifileucel.||
2570|123|P|Lifileucel may harm an unborn baby. Your doctor should order a||
2570|124|P|pregnancy test before you start this product. If you become||
2570|125|P|pregnant, talk to your doctor right away about the risks and||
2570|126|P|benefits of this product.||
2570|127|P|   It is unknown if this product passes into breast milk. Consult||
2570|128|P|your doctor before breastfeeding.||
2570|129|B|||
2570|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2570|131|I|medications work or increase your risk for serious side effects.||
2570|132|I|This document does not contain all possible drug interactions.||
2570|133|I|Keep a list of all the products you use (including||
2570|134|I|prescription/nonprescription drugs and herbal products) and share||
2570|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
2570|136|I|the dosage of any medicines without your doctor's approval.||
2570|137|B|||
2570|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2570|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2570|140|O|poison control center right away. US residents can call||
2570|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2570|142|B|||
2570|143|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2570|144|N|heart/lung/kidney function) should be done before and after you||
2570|145|N|receive this product. Keep all medical and lab appointments.||
2570|146|B|||
2570|147|D|MISSED DOSE:  Not applicable.||
2570|148|B|||
2570|149|R|STORAGE:  Not applicable. This product is given in a hospital and||
2570|150|R|will not be stored at home.||
2570|151|B|||
2570|152|M|MEDICAL ALERT:  Your condition can cause complications in a||
2570|153|M|medical emergency. For information about enrolling in MedicAlert,||
2570|154|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2570|155|B|||
2570|156|A|Information last revised September 2025.||
2570|157|A|Copyright(c) 2025 First Databank, Inc.||
2570|158|B|||
2571|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2571|002|Z|does NOT have all possible information about this product. This||
2571|003|Z|information does not assure that this product is safe, effective,||
2571|004|Z|or appropriate for you. This information is not individual||
2571|005|Z|medical advice and does not substitute for the advice of your||
2571|006|Z|health care professional. Always ask your health care||
2571|007|Z|professional for complete information about this product and your||
2571|008|Z|specific health needs.||
2571|009|B|||
2571|010|T|RESMETIROM - ORAL||
2571|011|F|(RES-me-TIR-om)||
2571|012|B|||
2571|013|C|COMMON BRAND NAME(S): Rezdiffra||
2571|014|B|||
2571|015|U|USES:  This medication is used to treat a certain liver disease||
2571|016|U|(nonalcoholic steatohepatitis-NASH). In people with NASH, fat||
2571|017|U|builds up in the liver leading to inflammation and more serious||
2571|018|U|liver problems over time. Resmetirom works by decreasing the||
2571|019|U|buildup of fat in the liver and may help prevent further liver||
2571|020|U|damage.||
2571|021|B|||
2571|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2571|023|H|from your pharmacist before you start taking resmetirom and each||
2571|024|H|time you get a refill. If you have any questions, ask your doctor||
2571|025|H|or pharmacist.||
2571|026|H|   Take this medication by mouth with or without food as directed||
2571|027|H|by your doctor, usually once daily. The dosage is based on your||
2571|028|H|weight and other medications you may be taking. Be sure to tell||
2571|029|H|your doctor and pharmacist about all the products you use||
2571|030|H|(including prescription drugs, nonprescription drugs, and herbal||
2571|031|H|products).||
2571|032|H|   Use this medication regularly to get the most benefit from it.||
2571|033|H|To help you remember, take it at the same time each day.||
2571|034|H|   Do not increase your dose or use this drug more often or for||
2571|035|H|longer than prescribed. Your condition will not improve any||
2571|036|H|faster, and your risk of side effects will increase.||
2571|037|H|   Tell your doctor if your condition does not get better or if||
2571|038|H|it gets worse.||
2571|039|B|||
2571|040|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, itching, or dizziness||
2571|041|S|may occur. If any of these effects last or get worse, tell your||
2571|042|S|doctor or pharmacist promptly.||
2571|043|S|   Remember that this medication has been prescribed because your||
2571|044|S|doctor has judged that the benefit to you is greater than the||
2571|045|S|risk of side effects. Many people using this medication do not||
2571|046|S|have serious side effects.||
2571|047|S|   Although resmetirom is used to treat a certain type of liver||
2571|048|S|disease, it may rarely cause other serious liver problems. Tell||
2571|049|S|your doctor right away if you have any new or worsening symptoms||
2571|050|S|of liver damage, such as: nausea/vomiting that doesn't stop, loss||
2571|051|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2571|052|S|urine.||
2571|053|S|   A very serious allergic reaction to this drug is rare.||
2571|054|S|However, get medical help right away if you notice any symptoms||
2571|055|S|of a serious allergic reaction, including: rash, itching/swelling||
2571|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2571|057|S|breathing.||
2571|058|S|   This is not a complete list of possible side effects. If you||
2571|059|S|notice other effects not listed above, contact your doctor or||
2571|060|S|pharmacist.||
2571|061|S|   In the US -||
2571|062|S|   Call your doctor for medical advice about side effects. You||
2571|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2571|064|S|www.fda.gov/medwatch.||
2571|065|S|   In Canada - Call your doctor for medical advice about side||
2571|066|S|effects. You may report side effects to Health Canada at||
2571|067|S|1-866-234-2345.||
2571|068|B|||
2571|069|P|PRECAUTIONS:  Before taking resmetirom, tell your doctor or||
2571|070|P|pharmacist if you are allergic to it; or if you have any other||
2571|071|P|allergies. This product may contain inactive ingredients, which||
2571|072|P|can cause allergic reactions or other problems. Talk to your||
2571|073|P|pharmacist for more details.||
2571|074|P|   Before using this medication, tell your doctor or pharmacist||
2571|075|P|your medical history, especially of: other liver problems (such||
2571|076|P|as cirrhosis), stones in your gallbladder (gallstones),||
2571|077|P|gallbladder disease (such as cholecystitis).||
2571|078|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2571|079|P|can make you more dizzy. Do not drive, use machinery, or do||
2571|080|P|anything that needs alertness until you can do it safely. Limit||
2571|081|P|alcoholic beverages. Talk to your doctor if you are using||
2571|082|P|marijuana (cannabis).||
2571|083|P|   Before having surgery, tell your doctor or dentist about all||
2571|084|P|the products you use (including prescription drugs,||
2571|085|P|nonprescription drugs, and herbal products).||
2571|086|P|   During pregnancy, this medication should be used only when||
2571|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
2571|088|P|   It is unknown if this medication passes into breast milk.||
2571|089|P|Consult your doctor before breastfeeding.||
2571|090|B|||
2571|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2571|092|I|medications work or increase your risk for serious side effects.||
2571|093|I|This document does not contain all possible drug interactions.||
2571|094|I|Keep a list of all the products you use (including||
2571|095|I|prescription/nonprescription drugs and herbal products) and share||
2571|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
2571|097|I|the dosage of any medicines without your doctor's approval.||
2571|098|I|   This medication can slow down the removal of other medications||
2571|099|I|from your body, which may affect how they work. Examples of||
2571|100|I|affected drugs include elagolix, elbasvir/grazoprevir, among||
2571|101|I|others.||
2571|102|I|   Other medications can affect the removal of resmetirom from||
2571|103|I|your body, which may affect how resmetirom works. Examples||
2571|104|I|include cyclosporine, gemfibrozil, among others.||
2571|105|B|||
2571|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2571|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2571|108|O|poison control center right away. US residents can call||
2571|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2571|110|B|||
2571|111|N|NOTES:  Do not share this medication with others.||
2571|112|N|   Lab and/or medical tests (such as liver function) should be||
2571|113|N|done while you are taking this medication. Keep all medical and||
2571|114|N|lab appointments. Consult your doctor for more details.||
2571|115|B|||
2571|116|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2571|117|D|remember. If it is near the time of the next dose, skip the||
2571|118|D|missed dose. Take your next dose at the regular time. Do not||
2571|119|D|double the dose to catch up.||
2571|120|B|||
2571|121|R|STORAGE:  Store at room temperature away from light and moisture.||
2571|122|R|Do not store in the bathroom. Keep all medications away from||
2571|123|R|children and pets.||
2571|124|R|   Do not flush medications down the toilet or pour them into a||
2571|125|R|drain unless instructed to do so. Properly discard this product||
2571|126|R|when it is expired or no longer needed. Consult your pharmacist||
2571|127|R|or local waste disposal company.||
2571|128|B|||
2571|129|A|Information last revised October 2024.||
2571|130|A|Copyright(c) 2025 First Databank, Inc.||
2571|131|B|||
2572|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2572|002|Z|does NOT have all possible information about this product. This||
2572|003|Z|information does not assure that this product is safe, effective,||
2572|004|Z|or appropriate for you. This information is not individual||
2572|005|Z|medical advice and does not substitute for the advice of your||
2572|006|Z|health care professional. Always ask your health care||
2572|007|Z|professional for complete information about this product and your||
2572|008|Z|specific health needs.||
2572|009|B|||
2572|010|T|MELPHALAN - INTRA-ARTERIAL||
2572|011|F|(MEL-fa-lan)||
2572|012|B|||
2572|013|C|COMMON BRAND NAME(S): Hepzato||
2572|014|B|||
2572|015|W|WARNING:  This medication is part of a kit that also includes a||
2572|016|W|Hepatic Delivery System (HDS). Melphalan is directly given to the||
2572|017|W|artery in the liver (hepatic intra-arterial) using the HDS||
2572|018|W|through a medical procedure. Melphalan and the procedure can||
2572|019|W|cause serious (rarely fatal) side effects such as bleeding, blood||
2572|020|W|clots, damage to the liver cells, or low blood pressure. You may||
2572|021|W|be at an increased risk if you have a history of liver problems||
2572|022|W|or liver surgery.||
2572|023|W|   To reduce your risk, your doctor may start other medications||
2572|024|W|(such as heparin) or stop medications you are currently taking||
2572|025|W|(such as blood pressure medications) before your procedure. Your||
2572|026|W|doctor may also monitor you during and for 72 hours after the||
2572|027|W|procedure.||
2572|028|W|   This medication may cause a severe decrease in your blood||
2572|029|W|cells, which lowers your ability to fight infections and||
2572|030|W|increases the risk of anemia/bleeding problems. You may be more||
2572|031|W|likely to get a serious (rarely fatal) infection or any infection||
2572|032|W|you have may get worse. Tell your doctor right away if you||
2572|033|W|develop signs of infection (such as sore throat that doesn't go||
2572|034|W|away, fever, chills), easy or unusual bruising/bleeding, or||
2572|035|W|unusual tiredness.||
2572|036|B|||
2572|037|U|USES:  This medication is used to treat serious liver problems||
2572|038|U|(liver metastases) that may occur with some types of skin cancer.||
2572|039|U|Melphalan belongs to a class of drugs known as alkylating agents.||
2572|040|U|It works by slowing or stopping the growth of cancer cells.||
2572|041|B|||
2572|042|H|HOW TO USE:  See also Warning section.||
2572|043|H|   Read the Patient Information Leaflet if available from your||
2572|044|H|pharmacist before you start using melphalan and each time you||
2572|045|H|receive this medication. If you have any questions, ask your||
2572|046|H|doctor or pharmacist.||
2572|047|H|   This medication is given by a health care professional using||
2572|048|H|the Hepatic Delivery System (HDS), usually every 6 to 8 weeks.||
2572|049|H|HDS uses a closed system of catheters to deliver melphalan||
2572|050|H|directly to the artery in the liver.||
2572|051|H|   The dosage is based on your medical condition, weight, lab||
2572|052|H|tests, and response to treatment.||
2572|053|B|||
2572|054|S|SIDE EFFECTS:  See also Warning section.||
2572|055|S|   Nausea, vomiting, diarrhea, stomach pain, muscle pain,||
2572|056|S|dizziness, headache, or loss of appetite may occur. Nausea and||
2572|057|S|vomiting can be severe. In some cases, your doctor may prescribe||
2572|058|S|medication to prevent or relieve nausea and vomiting. If any of||
2572|059|S|these effects last or get worse, tell your doctor or pharmacist||
2572|060|S|promptly.||
2572|061|S|   People using this medication may have serious side effects.||
2572|062|S|However, you have been prescribed this drug because your doctor||
2572|063|S|has judged that the benefit to you is greater than the risk of||
2572|064|S|side effects. Careful monitoring by your doctor may decrease your||
2572|065|S|risk.||
2572|066|S|   Although melphalan is used to treat cancer, it may rarely||
2572|067|S|increase your risk of developing other cancers. Tell your doctor||
2572|068|S|right away if you develop unusual growths/lumps or swollen lymph||
2572|069|S|nodes.||
2572|070|S|   A very serious allergic reaction to this drug is rare.||
2572|071|S|However, get medical help right away if you notice any symptoms||
2572|072|S|of a serious allergic reaction, including: rash, itching/swelling||
2572|073|S|(especially of the face/tongue/throat), severe dizziness, fast||
2572|074|S|heartbeat, trouble breathing.||
2572|075|S|   This is not a complete list of possible side effects. If you||
2572|076|S|notice other effects not listed above, contact your doctor or||
2572|077|S|pharmacist.||
2572|078|S|   In the US -||
2572|079|S|   Call your doctor for medical advice about side effects. You||
2572|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2572|081|S|www.fda.gov/medwatch.||
2572|082|S|   In Canada - Call your doctor for medical advice about side||
2572|083|S|effects. You may report side effects to Health Canada at||
2572|084|S|1-866-234-2345.||
2572|085|B|||
2572|086|P|PRECAUTIONS:  See also Warning section.||
2572|087|P|   Before receiving melphalan (as part of the kit), tell your||
2572|088|P|doctor or pharmacist if you are allergic to it; or to||
2572|089|P|chlorambucil; or to contrast media; or if you have any other||
2572|090|P|allergies. This product may contain inactive ingredients (such as||
2572|091|P|latex in the kit), which can cause allergic reactions or other||
2572|092|P|problems. Talk to your pharmacist for more details.||
2572|093|P|   Before using this medication, tell your doctor or pharmacist||
2572|094|P|your medical history, especially of: bleeding/blood problems,||
2572|095|P|cancer that has spread to the brain (metastases), liver problems||
2572|096|P|(such as liver failure), liver surgery/treatment (especially in||
2572|097|P|the past 4 weeks), heart problems (such as heart failure,||
2572|098|P|irregular heartbeat), radiation treatment.||
2572|099|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2572|100|P|can make you more dizzy. Do not drive, use machinery, or do||
2572|101|P|anything that needs alertness until you can do it safely. Limit||
2572|102|P|alcoholic beverages. Talk to your doctor if you are using||
2572|103|P|marijuana (cannabis).||
2572|104|P|   Melphalan can make you more likely to get infections or may||
2572|105|P|make current infections worse. Stay away from anyone who has an||
2572|106|P|infection that may easily spread (such as chickenpox, COVID-19,||
2572|107|P|measles, flu). Talk to your doctor if you have been exposed to an||
2572|108|P|infection or for more details.||
2572|109|P|   Tell your health care professional that you are using||
2572|110|P|melphalan before having any immunizations/vaccinations. Avoid||
2572|111|P|contact with people who have recently received live vaccines||
2572|112|P|(such as flu vaccine inhaled through the nose).||
2572|113|P|   To lower the chance of getting cut, bruised, or injured, use||
2572|114|P|caution with sharp objects like razors and nail cutters, and||
2572|115|P|avoid activities such as contact sports.||
2572|116|P|   Before having surgery, tell your doctor or dentist about all||
2572|117|P|the products you use (such as prescription drugs, nonprescription||
2572|118|P|drugs, and herbal products).||
2572|119|P|   This medication can affect fertility in both males and||
2572|120|P|females. Ask your doctor for more details.||
2572|121|P|   Tell your doctor if you are pregnant or plan to become||
2572|122|P|pregnant. You should not become pregnant while you are using||
2572|123|P|melphalan. Melphalan may harm an unborn baby. Your doctor should||
2572|124|P|order a pregnancy test before you start this medication. Women||
2572|125|P|using this medication should ask about reliable forms of birth||
2572|126|P|control during treatment and for 6 months after the last dose.||
2572|127|P|Men using this medication should ask about reliable forms of||
2572|128|P|birth control during treatment and for 3 months after the last||
2572|129|P|dose. If you or your partner becomes pregnant, talk to your||
2572|130|P|doctor right away about the risks and benefits of this||
2572|131|P|medication.||
2572|132|P|   It is unknown if this drug passes into breast milk. Because of||
2572|133|P|the possible risk to the infant, breastfeeding is not recommended||
2572|134|P|while using this drug and for 1 week after the last dose. Consult||
2572|135|P|your doctor before breastfeeding.||
2572|136|B|||
2572|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2572|138|I|medications work or increase your risk for serious side effects.||
2572|139|I|This document does not contain all possible drug interactions.||
2572|140|I|Keep a list of all the products you use (including||
2572|141|I|prescription/nonprescription drugs and herbal products) and share||
2572|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
2572|143|I|the dosage of any medicines without your doctor's approval.||
2572|144|I|   Melphalan is very similar to melphalan flufenamide. Do not use||
2572|145|I|medications containing melphalan flufenamide while using||
2572|146|I|melphalan.||
2572|147|B|||
2572|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2572|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2572|150|O|poison control center right away. US residents can call||
2572|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2572|152|B|||
2572|153|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2572|154|N|liver function) should be done while you are using this||
2572|155|N|medication. Keep all medical and lab appointments.||
2572|156|B|||
2572|157|D|MISSED DOSE:  It is important to get each dose of this medication||
2572|158|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2572|159|D|right away for a new dosing schedule.||
2572|160|B|||
2572|161|R|STORAGE:  Not applicable. This medication is given in a hospital||
2572|162|R|or clinic and will not be stored at home.||
2572|163|B|||
2572|164|M|MEDICAL ALERT:  Your condition can cause complications in a||
2572|165|M|medical emergency. For information about enrolling in MedicAlert,||
2572|166|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2572|167|B|||
2572|168|A|Information last revised May 2025.||
2572|169|A|Copyright(c) 2025 First Databank, Inc.||
2572|170|B|||
2573|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2573|002|Z|does NOT have all possible information about this product. This||
2573|003|Z|information does not assure that this product is safe, effective,||
2573|004|Z|or appropriate for you. This information is not individual||
2573|005|Z|medical advice and does not substitute for the advice of your||
2573|006|Z|health care professional. Always ask your health care||
2573|007|Z|professional for complete information about this product and your||
2573|008|Z|specific health needs.||
2573|009|B|||
2573|010|T|SPESOLIMAB - SUBCUTANEOUS INJECTION||
2573|011|B|||
2573|012|C|COMMON BRAND NAME(S): Spevigo||
2573|013|B|||
2573|014|U|USES:  This medication is used to treat a severe form of||
2573|015|U|psoriasis (generalized pustular psoriasis). Spesolimab belongs to||
2573|016|U|a class of drugs known as monoclonal antibodies. It works by||
2573|017|U|blocking a certain natural protein in your body (interleukin-36)||
2573|018|U|that may cause inflammation and swelling.||
2573|019|B|||
2573|020|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2573|021|H|provided by your pharmacist before you start using spesolimab and||
2573|022|H|each time you get a refill. Ask your health care professional how||
2573|023|H|to prepare and use this medication. If you have any questions,||
2573|024|H|ask your doctor or pharmacist.||
2573|025|H|   Before treatment with this medication, your doctor will test||
2573|026|H|you for tuberculosis (TB). Your doctor should also monitor you||
2573|027|H|for symptoms of TB during and after treatment with this drug. If||
2573|028|H|needed, treatment for TB or other infections should be given||
2573|029|H|before using this medication.||
2573|030|H|   Inject this medication under the skin as directed by your||
2573|031|H|doctor, usually every 4 weeks. The injection is given in the||
2573|032|H|abdomen or thigh. The first dose may be given by a healthcare||
2573|033|H|professional. If you are switching from the spesolimab product||
2573|034|H|that is injected into a vein, carefully follow your doctor's||
2573|035|H|directions for when to start using this medication.||
2573|036|H|   Take the medication out of the refrigerator 15 to 30 minutes||
2573|037|H|before you inject it to allow it to reach room temperature. Do||
2573|038|H|not warm up this medication any other way (for example, do not||
2573|039|H|heat it in the microwave or place it in hot water). This product||
2573|040|H|may contain a few tiny white or clear particles. Before using,||
2573|041|H|check this product for large particles or discoloration. If||
2573|042|H|either is present, do not use the liquid. Before injecting each||
2573|043|H|dose, clean the skin you are going to inject into (the injection||
2573|044|H|site) with rubbing alcohol. Change the injection site each time||
2573|045|H|to lessen injury under the skin. Do not inject into skin that is||
2573|046|H|sore, bruised, red, hard, or scarred. To lessen bruising, do not||
2573|047|H|rub the injection site after a shot. Learn how to store and||
2573|048|H|discard medical supplies safely.||
2573|049|H|   Use this medication regularly to get the most benefit from it.||
2573|050|H|To help you remember, mark your calendar with a reminder.||
2573|051|H|   Tell your doctor if your condition does not get better or if||
2573|052|H|it gets worse.||
2573|053|B|||
2573|054|S|SIDE EFFECTS:  Pain, redness, swelling, or itching at the||
2573|055|S|injection site may occur. If any of these effects last or get||
2573|056|S|worse, tell your doctor or pharmacist promptly.||
2573|057|S|   Remember that this medication has been prescribed because your||
2573|058|S|doctor has judged that the benefit to you is greater than the||
2573|059|S|risk of side effects. Many people using this medication do not||
2573|060|S|have serious side effects.||
2573|061|S|   This medication may lower your ability to fight infections.||
2573|062|S|This may make you more likely to get a serious (rarely fatal)||
2573|063|S|infection or make any infection you have worse. Get medical help||
2573|064|S|right away if you have any signs of infection (such as sore||
2573|065|S|throat that doesn't go away, fever, swollen lymph nodes, chills).||
2573|066|S|   A very serious allergic reaction to this drug is rare.||
2573|067|S|However, get medical help right away if you notice any symptoms||
2573|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2573|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2573|070|S|breathing.||
2573|071|S|   This is not a complete list of possible side effects. If you||
2573|072|S|notice other effects not listed above, contact your doctor or||
2573|073|S|pharmacist.||
2573|074|S|   In the US -||
2573|075|S|   Call your doctor for medical advice about side effects. You||
2573|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2573|077|S|www.fda.gov/medwatch.||
2573|078|S|   In Canada - Call your doctor for medical advice about side||
2573|079|S|effects. You may report side effects to Health Canada at||
2573|080|S|1-866-234-2345.||
2573|081|B|||
2573|082|P|PRECAUTIONS:  Before using spesolimab, tell your doctor or||
2573|083|P|pharmacist if you are allergic to it; or if you have any other||
2573|084|P|allergies. This product may contain inactive ingredients, which||
2573|085|P|can cause allergic reactions or other problems. Talk to your||
2573|086|P|pharmacist for more details.||
2573|087|P|   Before using this medication, tell your doctor or pharmacist||
2573|088|P|your medical history, especially of: current/recent/returning||
2573|089|P|infection (such as tuberculosis, herpes).||
2573|090|P|   Spesolimab can make you more likely to get infections or may||
2573|091|P|make current infections worse. Stay away from anyone who has an||
2573|092|P|infection that may easily spread (such as chickenpox, COVID-19,||
2573|093|P|measles, flu). Talk to your doctor if you have been exposed to an||
2573|094|P|infection or for more details.||
2573|095|P|   Tell your health care professional that you are using||
2573|096|P|spesolimab before having any immunizations/vaccinations. Avoid||
2573|097|P|getting a live vaccine while using this medication and for 16||
2573|098|P|weeks after the last dose. Avoid contact with people who have||
2573|099|P|recently received live vaccines (such as flu vaccine inhaled||
2573|100|P|through the nose).||
2573|101|P|   Before having surgery, tell your doctor or dentist about all||
2573|102|P|the products you use (including prescription drugs,||
2573|103|P|nonprescription drugs, and herbal products).||
2573|104|P|   During pregnancy, this medication should be used only when||
2573|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
2573|106|P|   It is unknown if this medication passes into breast milk.||
2573|107|P|Consult your doctor before breastfeeding.||
2573|108|B|||
2573|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2573|110|I|medications work or increase your risk for serious side effects.||
2573|111|I|This document does not contain all possible drug interactions.||
2573|112|I|Keep a list of all the products you use (including||
2573|113|I|prescription/nonprescription drugs and herbal products) and share||
2573|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
2573|115|I|the dosage of any medicines without your doctor's approval.||
2573|116|B|||
2573|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2573|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2573|119|O|poison control center right away. US residents can call||
2573|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2573|121|B|||
2573|122|N|NOTES:  Do not share this medication with others.||
2573|123|N|   Keep all medical and lab appointments.||
2573|124|B|||
2573|125|D|MISSED DOSE:  It is important to get each dose of this medication||
2573|126|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2573|127|D|right away for a new dosing schedule.||
2573|128|B|||
2573|129|R|STORAGE:  Different brands of this medication have different||
2573|130|R|storage needs. Check the product package for instructions on how||
2573|131|R|to store your brand, or ask your pharmacist. Keep all medications||
2573|132|R|away from children and pets.||
2573|133|R|   Do not flush medications down the toilet or pour them into a||
2573|134|R|drain unless instructed to do so. Properly discard this product||
2573|135|R|when it is expired or no longer needed. Consult your pharmacist||
2573|136|R|or local waste disposal company.||
2573|137|B|||
2573|138|A|Information last revised July 2025.||
2573|139|A|Copyright(c) 2025 First Databank, Inc.||
2573|140|B|||
2574|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2574|002|Z|does NOT have all possible information about this product. This||
2574|003|Z|information does not assure that this product is safe, effective,||
2574|004|Z|or appropriate for you. This information is not individual||
2574|005|Z|medical advice and does not substitute for the advice of your||
2574|006|Z|health care professional. Always ask your health care||
2574|007|Z|professional for complete information about this product and your||
2574|008|Z|specific health needs.||
2574|009|B|||
2574|010|T|ROFLUMILAST FOAM - TOPICAL||
2574|011|F|(roe-FLUE-mi-last)||
2574|012|B|||
2574|013|C|COMMON BRAND NAME(S): Zoryve||
2574|014|B|||
2574|015|U|USES:  This medication is used to treat certain skin conditions||
2574|016|U|(seborrheic dermatitis, plaque psoriasis). Roflumilast may help||
2574|017|U|to reduce the redness, itching, thickening, and scaling of the||
2574|018|U|skin that occurs with these conditions.||
2574|019|B|||
2574|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
2574|021|H|Instructions for Use if available from your pharmacist before you||
2574|022|H|start using roflumilast and each time you get a refill. If you||
2574|023|H|have any questions, ask your doctor or pharmacist.||
2574|024|H|   This medication is for use on the skin only. Shake the can||
2574|025|H|well before each use. Apply this medication to the affected area||
2574|026|H|and rub in completely as directed by your doctor, usually once||
2574|027|H|daily. Wash your hands after applying, unless you are treating||
2574|028|H|your hands. Avoid getting this medication in your eyes, mouth, or||
2574|029|H|vagina. If this happens, rinse right away with plenty of water.||
2574|030|H|   This medication is flammable until dry. Avoid smoking or being||
2574|031|H|near open flames while using the medication and until the||
2574|032|H|medication has dried.||
2574|033|H|   Use this medication regularly to get the most benefit from it.||
2574|034|H|To help you remember, use it at the same time each day.||
2574|035|H|   Tell your doctor if your condition does not get better or if||
2574|036|H|it gets worse.||
2574|037|B|||
2574|038|S|SIDE EFFECTS:  Nausea or headache may occur. If either of these||
2574|039|S|effects lasts or gets worse, tell your doctor or pharmacist||
2574|040|S|promptly.||
2574|041|S|   Remember that this medication has been prescribed because your||
2574|042|S|doctor has judged that the benefit to you is greater than the||
2574|043|S|risk of side effects. Many people using this medication do not||
2574|044|S|have serious side effects.||
2574|045|S|   A very serious allergic reaction to this drug is rare.||
2574|046|S|However, get medical help right away if you notice any symptoms||
2574|047|S|of a serious allergic reaction, including: rash, itching/swelling||
2574|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2574|049|S|breathing.||
2574|050|S|   This is not a complete list of possible side effects. If you||
2574|051|S|notice other effects not listed above, contact your doctor or||
2574|052|S|pharmacist.||
2574|053|S|   In the US -||
2574|054|S|   Call your doctor for medical advice about side effects. You||
2574|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2574|056|S|www.fda.gov/medwatch.||
2574|057|S|   In Canada - Call your doctor for medical advice about side||
2574|058|S|effects. You may report side effects to Health Canada at||
2574|059|S|1-866-234-2345.||
2574|060|B|||
2574|061|P|PRECAUTIONS:  Before using roflumilast, tell your doctor or||
2574|062|P|pharmacist if you are allergic to it; or if you have any other||
2574|063|P|allergies. This product may contain inactive ingredients, which||
2574|064|P|can cause allergic reactions or other problems. Talk to your||
2574|065|P|pharmacist for more details.||
2574|066|P|   Before using this medication, tell your doctor or pharmacist||
2574|067|P|your medical history, especially of: liver disease.||
2574|068|P|   Before having surgery, tell your doctor or dentist about all||
2574|069|P|the products you use (including prescription drugs,||
2574|070|P|nonprescription drugs, and herbal products).||
2574|071|P|   During pregnancy, this medication should be used only when||
2574|072|P|clearly needed. Discuss the risks and benefits with your doctor.||
2574|073|P|   It is unknown if this medication passes into breast milk.||
2574|074|P|Consult your doctor before breastfeeding.||
2574|075|B|||
2574|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2574|077|I|medications work or increase your risk for serious side effects.||
2574|078|I|This document does not contain all possible drug interactions.||
2574|079|I|Keep a list of all the products you use (including||
2574|080|I|prescription/nonprescription drugs and herbal products) and share||
2574|081|I|it with your doctor and pharmacist. Do not start, stop, or change||
2574|082|I|the dosage of any medicines without your doctor's approval.||
2574|083|B|||
2574|084|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2574|085|O|has overdosed and has serious symptoms such as passing out or||
2574|086|O|trouble breathing, call 911. Otherwise, call a poison control||
2574|087|O|center right away. US residents can call 1-800-222-1222. Canada||
2574|088|O|residents can call 1-844-764-7669.||
2574|089|B|||
2574|090|N|NOTES:  Do not share this medication with others.||
2574|091|B|||
2574|092|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
2574|093|D|remember. If it is near the time of the next dose, skip the||
2574|094|D|missed dose. Apply your next dose at the regular time. Do not||
2574|095|D|apply extra medicine to make up for the missed dose.||
2574|096|B|||
2574|097|R|STORAGE:  Store upright at room temperature. Do not freeze. This||
2574|098|R|product is flammable. Keep it away from heat and open flame. Do||
2574|099|R|not puncture the foam can. Keep all medications away from||
2574|100|R|children and pets.||
2574|101|R|   Do not flush medications down the toilet or pour them into a||
2574|102|R|drain unless instructed to do so. Properly discard this product||
2574|103|R|when it is expired or no longer needed. Consult your pharmacist||
2574|104|R|or local waste disposal company.||
2574|105|B|||
2574|106|A|Information last revised July 2025.||
2574|107|A|Copyright(c) 2025 First Databank, Inc.||
2574|108|B|||
2575|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2575|002|Z|does NOT have all possible information about this product. This||
2575|003|Z|information does not assure that this product is safe, effective,||
2575|004|Z|or appropriate for you. This information is not individual||
2575|005|Z|medical advice and does not substitute for the advice of your||
2575|006|Z|health care professional. Always ask your health care||
2575|007|Z|professional for complete information about this product and your||
2575|008|Z|specific health needs.||
2575|009|B|||
2575|010|T|SOTATERCEPT - INJECTION||
2575|011|F|(soe-TAT-er-sept)||
2575|012|B|||
2575|013|C|COMMON BRAND NAME(S):  Winrevair||
2575|014|B|||
2575|015|U|USES:  This medication is used to treat high blood pressure in||
2575|016|U|the lungs (pulmonary arterial hypertension-PAH). Sotatercept||
2575|017|U|helps to improve your ability to exercise and to slow down||
2575|018|U|worsening of PAH.||
2575|019|B|||
2575|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
2575|021|H|Instructions for Use if available from your pharmacist before you||
2575|022|H|start using sotatercept and each time you get a refill. Ask your||
2575|023|H|health care professional how to prepare and use this medication.||
2575|024|H|If you have any questions, ask your doctor or pharmacist.||
2575|025|H|   Inject this medication under the skin as directed by your||
2575|026|H|doctor, usually once every 3 weeks. The injection is given in the||
2575|027|H|upper thigh or abdomen (at least 2 inches from your belly||
2575|028|H|button). The dosage is based on your medical condition, labs,||
2575|029|H|weight, and response to treatment. To reduce your risk of side||
2575|030|H|effects, your doctor may direct you to start this medication at a||
2575|031|H|low dose and gradually increase your dose. Follow your doctor's||
2575|032|H|instructions carefully.||
2575|033|H|   Take the carton containing the medication and the solution||
2575|034|H|used to mix the medication out of the refrigerator 15 minutes||
2575|035|H|before you mix the product to allow it to reach room temperature.||
2575|036|H|After mixing, gently swirl to completely dissolve the powder. Do||
2575|037|H|not shake. Before using, check this product for particles or||
2575|038|H|discoloration. If either is present, do not use the liquid. Use||
2575|039|H|the mixed medication as soon as possible, but no later than 4||
2575|040|H|hours after mixing. Before injecting each dose, clean the skin||
2575|041|H|you are going to inject into (the injection site) with rubbing||
2575|042|H|alcohol. Change the injection site each time to lessen injury||
2575|043|H|under the skin. Do not inject into skin that is tender, bruised,||
2575|044|H|or red. To lessen bruising, do not rub the injection site after a||
2575|045|H|shot. Learn how to store and discard medical supplies safely.||
2575|046|H|   Use this medication regularly to get the most benefit from it.||
2575|047|H|To help you remember, mark your calendar with a reminder.||
2575|048|H|   Tell your doctor if your condition does not get better or if||
2575|049|H|it gets worse.||
2575|050|B|||
2575|051|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
2575|052|S|headache, diarrhea, nosebleeds, spider veins (telangiectasia), or||
2575|053|S|dizziness may occur. If any of these effects last or get worse,||
2575|054|S|tell your doctor or pharmacist promptly.||
2575|055|S|   Remember that this medication has been prescribed because your||
2575|056|S|doctor has judged that the benefit to you is greater than the||
2575|057|S|risk of side effects. Many people using this medication do not||
2575|058|S|have serious side effects.||
2575|059|S|   Tell your doctor right away if you have any serious side||
2575|060|S|effects, including: easy bruising/bleeding, bloody/black stools,||
2575|061|S|vomit that looks like coffee grounds.||
2575|062|S|   A very serious allergic reaction to this drug is rare.||
2575|063|S|However, get medical help right away if you notice any symptoms||
2575|064|S|of a serious allergic reaction, including: rash, itching/swelling||
2575|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2575|066|S|breathing.||
2575|067|S|   This is not a complete list of possible side effects. If you||
2575|068|S|notice other effects not listed above, contact your doctor or||
2575|069|S|pharmacist.||
2575|070|S|   In the US -||
2575|071|S|   Call your doctor for medical advice about side effects. You||
2575|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2575|073|S|www.fda.gov/medwatch.||
2575|074|S|   In Canada - Call your doctor for medical advice about side||
2575|075|S|effects. You may report side effects to Health Canada at||
2575|076|S|1-866-234-2345.||
2575|077|B|||
2575|078|P|PRECAUTIONS:  Before using sotatercept, tell your doctor or||
2575|079|P|pharmacist if you are allergic to it; or if you have any other||
2575|080|P|allergies. This product may contain inactive ingredients, which||
2575|081|P|can cause allergic reactions or other problems. Talk to your||
2575|082|P|pharmacist for more details.||
2575|083|P|   Before using this medication, tell your doctor or pharmacist||
2575|084|P|your medical history, especially of: bleeding problems, blood||
2575|085|P|disorders.||
2575|086|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2575|087|P|can make you more dizzy. Do not drive, use machinery, or do||
2575|088|P|anything that needs alertness until you can do it safely. Limit||
2575|089|P|alcoholic beverages. Talk to your doctor if you are using||
2575|090|P|marijuana (cannabis).||
2575|091|P|   Before having surgery, tell your doctor or dentist about all||
2575|092|P|the products you use (including prescription drugs,||
2575|093|P|nonprescription drugs, and herbal products).||
2575|094|P|   Tell your doctor if you are pregnant or plan to become||
2575|095|P|pregnant. You should not become pregnant while using sotatercept.||
2575|096|P|Sotatercept may harm an unborn baby. Your doctor should order a||
2575|097|P|pregnancy test before you start this medication. Ask about||
2575|098|P|reliable forms of birth control while using this medication and||
2575|099|P|for 4 months after the last dose. If you become pregnant, talk to||
2575|100|P|your doctor right away about the risks and benefits of this||
2575|101|P|medication.||
2575|102|P|   It is unknown if this medication passes into breast milk.||
2575|103|P|Because of the possible risk to the infant, breastfeeding is not||
2575|104|P|recommended while using this medication and for 4 months after||
2575|105|P|the last dose. Consult your doctor before breastfeeding.||
2575|106|B|||
2575|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2575|108|I|medications work or increase your risk for serious side effects.||
2575|109|I|This document does not contain all possible drug interactions.||
2575|110|I|Keep a list of all the products you use (including||
2575|111|I|prescription/nonprescription drugs and herbal products) and share||
2575|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2575|113|I|the dosage of any medicines without your doctor's approval.||
2575|114|B|||
2575|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2575|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2575|117|O|poison control center right away. US residents can call||
2575|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2575|119|B|||
2575|120|N|NOTES:  Keep all medical and lab appointments.||
2575|121|N|   Lab and/or medical tests (such as complete blood count) should||
2575|122|N|be done before you start using this medication and while you are||
2575|123|N|using it. Keep all medical and lab appointments. Consult your||
2575|124|N|doctor for more details.||
2575|125|B|||
2575|126|D|MISSED DOSE:  If you miss a dose and it is within 3 days after||
2575|127|D|the missed dose, use it as soon as you remember and then use your||
2575|128|D|next dose at the regular time. If it is more than 3 days after||
2575|129|D|the missed dose, ask your doctor or pharmacist right away for a||
2575|130|D|new dosing schedule. Do not double the dose to catch up.||
2575|131|B|||
2575|132|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2575|133|R|medication in the original packaging to protect from light. If||
2575|134|R|the medication is taken out of the refrigerator, discard after 24||
2575|135|R|hours. Keep all medications away from children and pets.||
2575|136|R|   Do not flush medications down the toilet or pour them into a||
2575|137|R|drain unless instructed to do so. Properly discard this product||
2575|138|R|when it is expired or no longer needed. Consult your pharmacist||
2575|139|R|or local waste disposal company.||
2575|140|B|||
2575|141|A|Information last revised February 2025.||
2575|142|A|Copyright(c) 2025 First Databank, Inc.||
2575|143|B|||
2576|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2576|002|Z|does NOT have all possible information about this product. This||
2576|003|Z|information does not assure that this product is safe, effective,||
2576|004|Z|or appropriate for you. This information is not individual||
2576|005|Z|medical advice and does not substitute for the advice of your||
2576|006|Z|health care professional. Always ask your health care||
2576|007|Z|professional for complete information about this product and your||
2576|008|Z|specific health needs.||
2576|009|B|||
2576|010|T|PEMIVIBART - INJECTION||
2576|011|B|||
2576|012|C|COMMON BRAND NAME(S): Pemgarda||
2576|013|B|||
2576|014|W|WARNING:  Pemivibart may cause serious (rarely fatal) allergic||
2576|015|W|reactions that may happen during infusion and for some time||
2576|016|W|afterward. Get medical help right away if you notice any signs of||
2576|017|W|a serious allergic reaction, such as rash, itching/swelling||
2576|018|W|(especially of the face/tongue/throat), severe dizziness, trouble||
2576|019|W|breathing, chest pain, or fast heartbeat. Your doctor may give||
2576|020|W|you other medications to help with these side effects and may||
2576|021|W|stop your treatment with this medication.||
2576|022|B|||
2576|023|U|USES:  Pemivibart is a medication that the FDA is allowing to be||
2576|024|U|given for emergency use to reduce the risk of getting COVID-19||
2576|025|U|infection in people who do not have COVID-19 and who have not||
2576|026|U|been exposed to anyone with COVID-19. To receive this product,||
2576|027|U|you must also have a weakened immune system because of certain||
2576|028|U|conditions or medications (such as cancer, transplant), which||
2576|029|U|reduces your response to the COVID-19 vaccine. It does not||
2576|030|U|replace the COVID-19 vaccines. Talk to your doctor about the||
2576|031|U|risks and benefits of treatment with pemivibart.||
2576|032|U|   This medication belongs to a class of drugs known as||
2576|033|U|monoclonal antibodies. It works by preventing the COVID-19 virus||
2576|034|U|from entering the cells in the body. This effect may prevent||
2576|035|U|COVID-19. More information about pemivibart is available from the||
2576|036|U|FDA Fact Sheet for Patients, Parents, and Caregivers for||
2576|037|U|Emergency Use provided by your health care professional. If you||
2576|038|U|are enrolled in a study, information should be provided by the||
2576|039|U|doctor via the Informed Consent Form.||
2576|040|U|   There is limited information about how safe and effective||
2576|041|U|pemivibart is for preventing COVID-19. This medication should not||
2576|042|U|be used to treat COVID-19 or in people who have already been||
2576|043|U|exposed to COVID-19.||
2576|044|U|   The information in this document reflects emerging data, which||
2576|045|U|is evolving and subject to reassessment. Users should be aware of||
2576|046|U|these considerations in their review of pemivibart, and it is||
2576|047|U|always the responsibility of treating practitioners to exercise||
2576|048|U|independent judgment in making care decisions.||
2576|049|B|||
2576|050|H|HOW TO USE:  This medication is given by slow injection into a||
2576|051|H|vein as directed by your doctor. It is infused by a health care||
2576|052|H|professional, usually over 60 minutes. If additional doses are||
2576|053|H|needed, this medication may be given by a health care||
2576|054|H|professional, every 3 months.||
2576|055|H|   The number of doses you receive depends on your medical||
2576|056|H|condition, new types of COVID-19 viruses (variants), and response||
2576|057|H|to treatment.||
2576|058|H|   If you received the COVID-19 vaccine, you should wait 2 weeks||
2576|059|H|before receiving this medication.||
2576|060|H|   Infusion reactions may happen during the infusion and for up||
2576|061|H|to 24 hours afterward. Tell your doctor right away if you have||
2576|062|H|any symptoms of infusion reactions such as fever, chills,||
2576|063|H|muscle/joint pain, flushing, fast/irregular heartbeat, headache,||
2576|064|H|or nausea. Your doctor may give you other medications to help||
2576|065|H|with these side effects or may slow down or stop your treatment||
2576|066|H|for some time.||
2576|067|B|||
2576|068|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2576|069|S|   Pain, redness, swelling, or soreness may occur at the||
2576|070|S|injection site. If any of these effects last or get worse, tell||
2576|071|S|your doctor or pharmacist promptly.||
2576|072|S|   Information is limited and it is unknown at this time if||
2576|073|S|pemivibart causes other serious side effects. This is not||
2576|074|S|necessarily a complete list of possible side effects.||
2576|075|S|   Contact your doctor for medical advice about side effects.||
2576|076|B|||
2576|077|P|PRECAUTIONS:  Before using this medication, tell your doctor if||
2576|078|P|you have any allergies. Pemivibart may contain inactive||
2576|079|P|ingredients, which can cause allergic reactions or other||
2576|080|P|problems.||
2576|081|P|   Limited information is known at this time about other medical||
2576|082|P|conditions that may affect how pemivibart works, or how||
2576|083|P|pemivibart may affect other medical conditions.||
2576|084|P|   Before using this medication, tell your doctor your medical||
2576|085|P|history.||
2576|086|P|   During pregnancy, this medication should be used only when||
2576|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
2576|088|P|   It is unknown if this medication passes into breast milk.||
2576|089|P|Consult your doctor before breastfeeding.||
2576|090|B|||
2576|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2576|092|I|medications work or increase your risk for serious side effects.||
2576|093|I|Information is limited and it is unknown at this time if||
2576|094|I|pemivibart has drug interactions. Keep a list of all the products||
2576|095|I|you use (including prescription/nonprescription drugs and herbal||
2576|096|I|products) and share it with your doctor and pharmacist. Do not||
2576|097|I|start, stop, or change the dosage of any medicines without your||
2576|098|I|doctor's approval.||
2576|099|B|||
2576|100|O|OVERDOSE:  Overdose information is not available at this time.||
2576|101|B|||
2576|102|N|NOTES:  Not applicable.||
2576|103|B|||
2576|104|D|MISSED DOSE:  Not applicable.||
2576|105|B|||
2576|106|R|STORAGE:  Not applicable. This medication is given in a hospital||
2576|107|R|and will not be stored at home.||
2576|108|B|||
2576|109|A|Information last revised May 2024.||
2576|110|A|Copyright(c) 2025 First Databank, Inc.||
2576|111|B|||
2577|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2577|002|Z|does NOT have all possible information about this product. This||
2577|003|Z|information does not assure that this product is safe, effective,||
2577|004|Z|or appropriate for you. This information is not individual||
2577|005|Z|medical advice and does not substitute for the advice of your||
2577|006|Z|health care professional. Always ask your health care||
2577|007|Z|professional for complete information about this product and your||
2577|008|Z|specific health needs.||
2577|009|B|||
2577|010|T|DANICOPAN - ORAL||
2577|011|F|(DAN-i-KOE-pan)||
2577|012|B|||
2577|013|C|COMMON BRAND NAME(S): Voydeya||
2577|014|B|||
2577|015|W|WARNING:  Danicopan can lower your body's ability to fight||
2577|016|W|infections. This increases your chance of getting very serious||
2577|017|W|(possibly fatal) infections (especially meningitis or sepsis).||
2577|018|W|   Your doctor may prescribe certain vaccines for you to get at||
2577|019|W|least 2 weeks before your first dose of this medication. Vaccines||
2577|020|W|may not fully protect everyone who receives them, so you should||
2577|021|W|still watch for signs of infection after you get the vaccine. Get||
2577|022|W|medical help right away if you develop symptoms such as||
2577|023|W|nausea/vomiting that doesn't stop, fever, chills, severe||
2577|024|W|headache, stiff neck, mental/mood changes (such as confusion),||
2577|025|W|muscle aches with flu-like symptoms, eye sensitivity to light.||
2577|026|W|   To receive danicopan in the United States, you must||
2577|027|W|understand, agree to, and carefully follow the requirements of||
2577|028|W|the REMS Program for this medication. If you live in Canada or||
2577|029|W|any other country, consult your doctor and pharmacist for your||
2577|030|W|country's regulations.||
2577|031|B|||
2577|032|U|USES:  Danicopan is used to treat a certain blood disorder||
2577|033|U|(paroxysmal nocturnal hemoglobinuria). This disorder causes your||
2577|034|U|body's immune system to break down red blood cells, which results||
2577|035|U|in anemia. Danicopan works by helping to block the body's||
2577|036|U|breakdown of red blood cells. This effect helps lessen symptoms||
2577|037|U|of anemia (such as tiredness, shortness of breath) and may reduce||
2577|038|U|the need for blood transfusions.||
2577|039|B|||
2577|040|H|HOW TO USE:  Read the Medication Guide provided by your||
2577|041|H|pharmacist before you start taking danicopan and each time you||
2577|042|H|get a refill. Carry the Patient Safety Card with you at all times||
2577|043|H|during treatment and for 1 week after your last dose of||
2577|044|H|danicopan. If you have any questions, ask your doctor or||
2577|045|H|pharmacist.||
2577|046|H|   Take this medication by mouth with or without food as directed||
2577|047|H|by your doctor, usually 3 times a day. The dosage is based on||
2577|048|H|your medical condition and response to treatment.||
2577|049|H|   Use this medication regularly to get the most benefit from it.||
2577|050|H|To help you remember, take it at the same times each day.||
2577|051|H|   Do not increase your dose or use this drug more often or for||
2577|052|H|longer than prescribed. Your condition will not improve any||
2577|053|H|faster, and your risk of side effects will increase.||
2577|054|H|   Do not stop taking this medication without consulting your||
2577|055|H|doctor. Your condition may become worse when the drug is stopped.||
2577|056|H|If you do stop taking this medication, your doctor will monitor||
2577|057|H|you for at least 2 weeks after the last dose to make sure your||
2577|058|H|condition does not get worse. Consult your doctor for more||
2577|059|H|details.||
2577|060|H|   Tell your doctor if your condition does not get better or if||
2577|061|H|it gets worse.||
2577|062|B|||
2577|063|S|SIDE EFFECTS:  See also Warning section.||
2577|064|S|   Headache may occur. If this effect lasts or gets worse, tell||
2577|065|S|your doctor or pharmacist promptly.||
2577|066|S|   Remember that this medication has been prescribed because your||
2577|067|S|doctor has judged that the benefit to you is greater than the||
2577|068|S|risk of side effects. Many people using this medication do not||
2577|069|S|have serious side effects.||
2577|070|S|   Tell your doctor right away if you have any serious side||
2577|071|S|effects, including: signs of liver disease (such as||
2577|072|S|nausea/vomiting that doesn't stop, loss of appetite,||
2577|073|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2577|074|S|   A very serious allergic reaction to this drug is rare.||
2577|075|S|However, get medical help right away if you notice any symptoms||
2577|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2577|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2577|078|S|breathing.||
2577|079|S|   This is not a complete list of possible side effects. If you||
2577|080|S|notice other effects not listed above, contact your doctor or||
2577|081|S|pharmacist.||
2577|082|S|   In the US -||
2577|083|S|   Call your doctor for medical advice about side effects. You||
2577|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2577|085|S|www.fda.gov/medwatch.||
2577|086|S|   In Canada - Call your doctor for medical advice about side||
2577|087|S|effects. You may report side effects to Health Canada at||
2577|088|S|1-866-234-2345.||
2577|089|B|||
2577|090|P|PRECAUTIONS:  See also Warning section.||
2577|091|P|   Before taking danicopan, tell your doctor or pharmacist if you||
2577|092|P|are allergic to it; or if you have any other allergies. This||
2577|093|P|product may contain inactive ingredients, which can cause||
2577|094|P|allergic reactions or other problems. Talk to your pharmacist for||
2577|095|P|more details.||
2577|096|P|   Before using this medication, tell your doctor or pharmacist||
2577|097|P|your medical history, especially of: current/recent infection,||
2577|098|P|liver disease.||
2577|099|P|   Danicopan can make you more likely to get certain infections||
2577|100|P|(such as meningitis, pneumonia). Talk to your doctor for more||
2577|101|P|details.||
2577|102|P|   Tell your doctor your vaccine history and ask if you need to||
2577|103|P|get any vaccines before starting treatment with this medication.||
2577|104|P|Tell your health care professional that you are using danicopan||
2577|105|P|before having any immunizations/vaccinations. Avoid contact with||
2577|106|P|people who have recently received live vaccines (such as flu||
2577|107|P|vaccine inhaled through the nose).||
2577|108|P|   Before having surgery, tell your doctor or dentist about all||
2577|109|P|the products you use (including prescription drugs,||
2577|110|P|nonprescription drugs, and herbal products).||
2577|111|P|   During pregnancy, this medication should be used only when||
2577|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
2577|113|P|   It is unknown if this medication passes into breast milk.||
2577|114|P|Because of the possible risk to the infant, breastfeeding is not||
2577|115|P|recommended while using this medication and for 3 days after the||
2577|116|P|last dose. Consult your doctor before breastfeeding.||
2577|117|B|||
2577|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2577|119|I|medications work or increase your risk for serious side effects.||
2577|120|I|This document does not contain all possible drug interactions.||
2577|121|I|Keep a list of all the products you use (including||
2577|122|I|prescription/nonprescription drugs and herbal products) and share||
2577|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
2577|124|I|the dosage of any medicines without your doctor's approval.||
2577|125|B|||
2577|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2577|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2577|128|O|poison control center right away. US residents can call||
2577|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2577|130|B|||
2577|131|N|NOTES:  Do not share this medication with others.||
2577|132|N|   Lab and/or medical tests (such as liver function, complete||
2577|133|N|blood count, blood cholesterol level) should be done while you||
2577|134|N|are taking this medication. Keep all medical and lab||
2577|135|N|appointments. Consult your doctor for more details.||
2577|136|B|||
2577|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2577|138|D|remember. If it is within 3 hours of the next dose, skip the||
2577|139|D|missed dose. Take your next dose at the regular time. Do not||
2577|140|D|double the dose to catch up.||
2577|141|B|||
2577|142|R|STORAGE:  Store in the original container at room temperature||
2577|143|R|away from light and moisture. Do not store in the bathroom. Keep||
2577|144|R|all medications away from children and pets.||
2577|145|R|   Do not flush medications down the toilet or pour them into a||
2577|146|R|drain unless instructed to do so. Properly discard this product||
2577|147|R|when it is expired or no longer needed. Consult your pharmacist||
2577|148|R|or local waste disposal company.||
2577|149|B|||
2577|150|M|MEDICAL ALERT:  Your condition can cause complications in a||
2577|151|M|medical emergency. For information about enrolling in MedicAlert,||
2577|152|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2577|153|B|||
2577|154|A|Information last revised May 2024.||
2577|155|A|Copyright(c) 2025 First Databank, Inc.||
2577|156|B|||
2578|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2578|002|Z|does NOT have all possible information about this product. This||
2578|003|Z|information does not assure that this product is safe, effective,||
2578|004|Z|or appropriate for you. This information is not individual||
2578|005|Z|medical advice and does not substitute for the advice of your||
2578|006|Z|health care professional. Always ask your health care||
2578|007|Z|professional for complete information about this product and your||
2578|008|Z|specific health needs.||
2578|009|B|||
2578|010|T|SODIUM FLUORIDE/HYDROXYAPATITE GEL - DENTAL||
2578|011|B|||
2578|012|C|COMMON BRAND NAME(S): Fraiche 5000 Kids Plus, Fraiche 5000 Previ||
2578|013|B|||
2578|014|U|USES:  This medication is used to prevent cavities and to reduce||
2578|015|U|pain from sensitive teeth (dentinal hypersensitivity). Sodium||
2578|016|U|fluoride and hydroxyapatite work by making the teeth stronger and||
2578|017|U|more resistant to decay caused by acid and bacteria.||
2578|018|U|Hydroxyapatite may also coat sensitive areas of the teeth.||
2578|019|U|   Do not use this medication for children younger than 6 years||
2578|020|U|unless directed by the doctor/dentist. Ask the doctor/dentist for||
2578|021|U|more details about using this product safely for children.||
2578|022|U|Caregivers/parents should watch the child to make sure the child||
2578|023|U|does not swallow the medication while brushing.||
2578|024|B|||
2578|025|H|HOW TO USE:  Use this medication as directed by your||
2578|026|H|doctor/dentist, usually twice daily (once in the morning and once||
2578|027|H|in the evening).||
2578|028|H|   Use this medication in place of your regular toothpaste unless||
2578|029|H|otherwise directed by your doctor/dentist. Apply at least a||
2578|030|H|1-inch (2.5 centimeters) strip of the medication to a||
2578|031|H|soft-bristled toothbrush, and brush your teeth for at least 1||
2578|032|H|minute. Spit out the medication after use and rinse your mouth||
2578|033|H|thoroughly.||
2578|034|H|   Do not swallow the medication. Make sure to brush all||
2578|035|H|sensitive areas of the teeth.||
2578|036|H|   Use this medication regularly to get the most benefit from it.||
2578|037|H|To help you remember, use it at the same times each day.||
2578|038|H|   Do not use this medication for longer than 4 weeks unless||
2578|039|H|directed by your doctor/dentist. Sensitive/painful teeth may||
2578|040|H|sometimes be a symptom of a serious problem that needs attention||
2578|041|H|from a dentist.||
2578|042|H|   Tell your doctor/dentist if your symptoms last or get worse.||
2578|043|B|||
2578|044|S|SIDE EFFECTS:  Mouth/gum irritation may rarely occur. If this||
2578|045|S|effect lasts or gets worse, tell your doctor/dentist or||
2578|046|S|pharmacist promptly.||
2578|047|S|   Tell your doctor/dentist right away if your teeth become||
2578|048|S|stained or pitted. This is often a result of too much fluoride.||
2578|049|S|   Remember that this medication has been prescribed because your||
2578|050|S|doctor has judged that the benefit to you is greater than the||
2578|051|S|risk of side effects. Many people using this medication do not||
2578|052|S|have serious side effects.||
2578|053|S|   A very serious allergic reaction to this drug is rare.||
2578|054|S|However, get medical help right away if you notice any symptoms||
2578|055|S|of a serious allergic reaction, including: rash, itching/swelling||
2578|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2578|057|S|breathing.||
2578|058|S|   This is not a complete list of possible side effects. If you||
2578|059|S|notice other effects not listed above, contact your||
2578|060|S|doctor/dentist or pharmacist.||
2578|061|S|   In the US -||
2578|062|S|   Call your doctor for medical advice about side effects. You||
2578|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2578|064|S|www.fda.gov/medwatch.||
2578|065|S|   In Canada - Call your doctor for medical advice about side||
2578|066|S|effects. You may report side effects to Health Canada at||
2578|067|S|1-866-234-2345.||
2578|068|B|||
2578|069|P|PRECAUTIONS:  Before using this medication, tell your||
2578|070|P|doctor/dentist or pharmacist if you are allergic to sodium||
2578|071|P|fluoride or hydroxyapatite; or if you have any other allergies.||
2578|072|P|This product may contain inactive ingredients, which can cause||
2578|073|P|allergic reactions or other problems. Talk to your pharmacist for||
2578|074|P|more details.||
2578|075|P|   Before using this medication, tell your doctor/dentist or||
2578|076|P|pharmacist your medical history, especially of: mouth problems||
2578|077|P|(such as sores, mucositis).||
2578|078|P|   Tell your doctor if you are pregnant before using this||
2578|079|P|medication.||
2578|080|P|   It is unknown if this medication passes into breast milk.||
2578|081|P|Consult your doctor before breastfeeding.||
2578|082|B|||
2578|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2578|084|I|medications work or increase your risk for serious side effects.||
2578|085|I|This document does not contain all possible drug interactions.||
2578|086|I|Keep a list of all the products you use (including||
2578|087|I|prescription/nonprescription drugs and herbal products) and share||
2578|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
2578|089|I|the dosage of any medicines without your doctor's approval.||
2578|090|B|||
2578|091|O|OVERDOSE:  This medication may be harmful if swallowed in large||
2578|092|O|amounts. If someone has overdosed and has serious symptoms such||
2578|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2578|094|O|poison control center right away. US residents can call||
2578|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2578|096|O|Symptoms of overdose may include: nausea/vomiting, increased||
2578|097|O|saliva, stomach pain/cramping, muscle weakness, shaking.||
2578|098|B|||
2578|099|N|NOTES:  Do not share this medication with others.||
2578|100|N|   Using this medication does not replace good dental habits.||
2578|101|N|Continue to floss your teeth regularly as directed by your||
2578|102|N|dentist, and have regular dental checkups.||
2578|103|N|   Sensitive teeth can be caused by damage to the hard outside||
2578|104|N|surface of the tooth (enamel). Avoid acidic food/drinks (such as||
2578|105|N|ginger ale, limes/lemons, citrus-based drinks, coffee), which can||
2578|106|N|damage the tooth enamel. Consult your doctor/dentist for more||
2578|107|N|details.||
2578|108|B|||
2578|109|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2578|110|D|If it is near the time of the next dose, skip the missed dose.||
2578|111|D|Use your next dose at the regular time. Do not double the dose to||
2578|112|D|catch up.||
2578|113|B|||
2578|114|R|STORAGE:  Store at room temperature. Keep all medications away||
2578|115|R|from children and pets.||
2578|116|R|   Do not flush medications down the toilet or pour them into a||
2578|117|R|drain unless instructed to do so. Properly discard this product||
2578|118|R|when it is expired or no longer needed. Consult your pharmacist||
2578|119|R|or local waste disposal company.||
2578|120|B|||
2578|121|A|Information last revised May 2024.||
2578|122|A|Copyright(c) 2025 First Databank, Inc.||
2578|123|B|||
2579|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2579|002|Z|does NOT have all possible information about this product. This||
2579|003|Z|information does not assure that this product is safe, effective,||
2579|004|Z|or appropriate for you. This information is not individual||
2579|005|Z|medical advice and does not substitute for the advice of your||
2579|006|Z|health care professional. Always ask your health care||
2579|007|Z|professional for complete information about this product and your||
2579|008|Z|specific health needs.||
2579|009|B|||
2579|010|T|APROCITENTAN - ORAL||
2579|011|F|(A-proe-sye-TEN-tan)||
2579|012|B|||
2579|013|C|COMMON BRAND NAME(S): Tryvio||
2579|014|B|||
2579|015|W|WARNING:  This medication must not be used during pregnancy. It||
2579|016|W|may harm an unborn baby. It is important to prevent pregnancy||
2579|017|W|while taking this medication and for 1 month after treatment.||
2579|018|W|Female patients must use reliable birth control before starting||
2579|019|W|treatment, during treatment, and for 1 month after the last dose.||
2579|020|W|Ask your doctor which forms of birth control to use while taking||
2579|021|W|this medication. Female patients must take a pregnancy test||
2579|022|W|before starting treatment. If you become pregnant or think you||
2579|023|W|may be pregnant, tell your doctor right away.||
2579|024|B|||
2579|025|U|USES:  Aprocitentan is used along with other medications to treat||
2579|026|U|high blood pressure. Lowering high blood pressure helps prevent||
2579|027|U|strokes, heart attacks, and kidney problems.||
2579|028|U|   This medication works by relaxing blood vessels so blood can||
2579|029|U|flow more easily.||
2579|030|B|||
2579|031|H|HOW TO USE:  Read the Medication Guide provided by your||
2579|032|H|pharmacist before you start using aprocitentan and each time you||
2579|033|H|get a refill. If you have any questions, ask your doctor or||
2579|034|H|pharmacist.||
2579|035|H|   Take this medication by mouth with or without food as directed||
2579|036|H|by your doctor, usually once daily. Swallow the tablets whole.||
2579|037|H|   Use this medication regularly to get the most benefit from it.||
2579|038|H|To help you remember, take it at the same time each day.||
2579|039|H|   Since this drug can be absorbed through the skin and lungs and||
2579|040|H|may harm an unborn baby, women who are pregnant or who may become||
2579|041|H|pregnant should not handle this medication or breathe the dust||
2579|042|H|from the tablets.||
2579|043|H|   Tell your doctor if your condition does not get better or if||
2579|044|H|it gets worse (your blood pressure readings remain high or||
2579|045|H|increase).||
2579|046|B|||
2579|047|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
2579|048|S|because your doctor has judged that the benefit to you is greater||
2579|049|S|than the risk of side effects. Many people using this medication||
2579|050|S|do not have serious side effects.||
2579|051|S|   Tell your doctor right away if you have any serious side||
2579|052|S|effects, including: fast heartbeat, shortness of breath, unusual||
2579|053|S|tiredness, swelling ankles/feet, sudden/unexplained weight gain.||
2579|054|S|   Other medications that are like aprocitentan may rarely cause||
2579|055|S|very serious liver problems. Tell your doctor right away if you||
2579|056|S|develop symptoms of liver disease, including: nausea/vomiting||
2579|057|S|that doesn't stop, loss of appetite, stomach/abdominal pain,||
2579|058|S|yellowing eyes/skin, dark urine.||
2579|059|S|   A very serious allergic reaction to this drug is rare.||
2579|060|S|However, get medical help right away if you notice any symptoms||
2579|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2579|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2579|063|S|breathing.||
2579|064|S|   This is not a complete list of possible side effects. If you||
2579|065|S|notice other effects not listed above, contact your doctor or||
2579|066|S|pharmacist.||
2579|067|S|   In the US -||
2579|068|S|   Call your doctor for medical advice about side effects. You||
2579|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2579|070|S|www.fda.gov/medwatch.||
2579|071|S|   In Canada - Call your doctor for medical advice about side||
2579|072|S|effects. You may report side effects to Health Canada at||
2579|073|S|1-866-234-2345.||
2579|074|B|||
2579|075|P|PRECAUTIONS:  Before taking aprocitentan, tell your doctor or||
2579|076|P|pharmacist if you are allergic to it; or if you have any other||
2579|077|P|allergies. This product may contain inactive ingredients, which||
2579|078|P|can cause allergic reactions or other problems. Talk to your||
2579|079|P|pharmacist for more details.||
2579|080|P|   Before using this medication, tell your doctor or pharmacist||
2579|081|P|your medical history, especially of: liver disease, kidney||
2579|082|P|problems, anemia, heart failure.||
2579|083|P|   Before having surgery, tell your doctor or dentist about all||
2579|084|P|the products you use (including prescription drugs,||
2579|085|P|nonprescription drugs, and herbal products).||
2579|086|P|   Older adults may be at greater risk for swelling ankles/feet||
2579|087|P|while using this drug.||
2579|088|P|   This medication can affect fertility in males. Ask your doctor||
2579|089|P|for more details.||
2579|090|P|   Since this drug can be absorbed through the skin and lungs and||
2579|091|P|may harm an unborn baby, women who are pregnant or who may become||
2579|092|P|pregnant should not handle this medication or breathe the dust||
2579|093|P|from the tablets.||
2579|094|P|   This medication must not be used during pregnancy. It may harm||
2579|095|P|an unborn baby. Discuss the use of reliable forms of birth||
2579|096|P|control (such as condoms, birth control pills) before starting||
2579|097|P|treatment, during treatment, and for 1 month after the last dose.||
2579|098|P|If you become pregnant or think you may be pregnant, tell your||
2579|099|P|doctor right away. See also Warning section.||
2579|100|P|   It is unknown if this medication passes into breast milk.||
2579|101|P|Because of the possible risk to the infant, breastfeeding is not||
2579|102|P|recommended while using this medication. Consult your doctor||
2579|103|P|before breastfeeding.||
2579|104|B|||
2579|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2579|106|I|medications work or increase your risk for serious side effects.||
2579|107|I|This document does not contain all possible drug interactions.||
2579|108|I|Keep a list of all the products you use (including||
2579|109|I|prescription/nonprescription drugs and herbal products) and share||
2579|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
2579|111|I|the dosage of any medicines without your doctor's approval.||
2579|112|I|   A product that may interact with this drug is: sparsentan.||
2579|113|B|||
2579|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2579|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2579|116|O|poison control center right away. US residents can call||
2579|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2579|118|B|||
2579|119|N|NOTES:  Do not share this medication with others.||
2579|120|N|   Lab and/or medical tests (such as liver function, hemoglobin||
2579|121|N|level) should be done before you start taking this medication and||
2579|122|N|while you are taking it. Keep all medical and lab appointments.||
2579|123|N|Consult your doctor for more details.||
2579|124|B|||
2579|125|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2579|126|D|next dose at the regular time. Do not double the dose to catch||
2579|127|D|up.||
2579|128|B|||
2579|129|R|STORAGE:  Store in the original container at room temperature||
2579|130|R|away from light and moisture. Do not store in the bathroom. Keep||
2579|131|R|the drying agent (desiccant) in the bottle. Tightly close the||
2579|132|R|bottle when not in use. Keep all medications away from children||
2579|133|R|and pets.||
2579|134|R|   Do not flush medications down the toilet or pour them into a||
2579|135|R|drain unless instructed to do so. Properly discard this product||
2579|136|R|when it is expired or no longer needed. Consult your pharmacist||
2579|137|R|or local waste disposal company.||
2579|138|B|||
2579|139|A|Information last revised April 2025.||
2579|140|A|Copyright(c) 2025 First Databank, Inc.||
2579|141|B|||
2580|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2580|002|Z|does NOT have all possible information about this product. This||
2580|003|Z|information does not assure that this product is safe, effective,||
2580|004|Z|or appropriate for you. This information is not individual||
2580|005|Z|medical advice and does not substitute for the advice of your||
2580|006|Z|health care professional. Always ask your health care||
2580|007|Z|professional for complete information about this product and your||
2580|008|Z|specific health needs.||
2580|009|B|||
2580|010|T|DIAZEPAM FILM - BUCCAL||
2580|011|F|(dye-AZ-e-pam)||
2580|012|B|||
2580|013|C|COMMON BRAND NAME(S): Libervant||
2580|014|B|||
2580|015|W|WARNING:  Diazepam has a risk for abuse and addiction, which can||
2580|016|W|lead to overdose and death. Using this medication with alcohol or||
2580|017|W|other drugs that can cause drowsiness or breathing problems||
2580|018|W|(especially opioid medications such as codeine, hydrocodone) may||
2580|019|W|cause very serious side effects, including death. To lower your||
2580|020|W|child's risk, the doctor should have you use the smallest dose of||
2580|021|W|diazepam that works, and use it for the shortest possible time.||
2580|022|W|Be sure you know how to use diazepam and what other drugs your||
2580|023|W|child should avoid taking with it. See also Drug Interactions||
2580|024|W|section. Get medical help right away if your child has any of||
2580|025|W|these very serious side effects: slow/shallow breathing, unusual||
2580|026|W|lightheadedness, severe drowsiness/dizziness, difficulty waking||
2580|027|W|up.||
2580|028|W|   This medication should not be used regularly. If your child||
2580|029|W|uses it regularly, suddenly stopping this medication may cause||
2580|030|W|serious (possibly fatal) withdrawal, especially if they have used||
2580|031|W|it for a long time or in high doses. To prevent withdrawal, the||
2580|032|W|doctor may lower the dose slowly. Tell the doctor or pharmacist||
2580|033|W|right away if your child has any withdrawal symptoms such as||
2580|034|W|headaches, trouble sleeping, restlessness,||
2580|035|W|hallucinations/confusion, depression, nausea, or seizures that||
2580|036|W|will not stop. Withdrawal symptoms may sometimes last weeks to||
2580|037|W|months.||
2580|038|B|||
2580|039|U|USES:  This form of diazepam is given to children with epilepsy||
2580|040|U|to treat a certain type of serious seizure that doesn't stop||
2580|041|U|(seizure clusters). Diazepam works by calming the brain and||
2580|042|U|nerves. It belongs to a class of drugs known as benzodiazepines.||
2580|043|B|||
2580|044|H|HOW TO USE:  See also Warning section.||
2580|045|H|   Read the Medication Guide and Instructions for Use provided by||
2580|046|H|the pharmacist before your child starts diazepam and each time||
2580|047|H|you get a refill. Be sure to keep this medication handy in case||
2580|048|H|it is needed. Learn ahead of time how to properly use this||
2580|049|H|medication. Caregivers should learn when this medication should||
2580|050|H|be used and what to watch for after using this medication. If||
2580|051|H|there are any questions, ask the doctor or pharmacist.||
2580|052|H|   This medication is given by mouth with or without food as||
2580|053|H|directed by the doctor. Do not give with any liquids. The dosage||
2580|054|H|is based on your child's weight and response to treatment.||
2580|055|H|   Remove the diazepam film from the foil package only when you||
2580|056|H|are ready to use it. Do not cut the film. Make sure your hands||
2580|057|H|are clean and dry before touching the film. Stretch your child's||
2580|058|H|mouth open with one hand. With the other hand, place one film||
2580|059|H|flat inside either cheek. Do not rub the film into the cheek. Do||
2580|060|H|not place the film on the teeth. The film should stay in place on||
2580|061|H|its own after this. Leave it in place until it is dissolved. The||
2580|062|H|film should not be chewed or swallowed whole. If your child spits||
2580|063|H|or blows out the film right away, you may give a new film.||
2580|064|H|   In some cases, a second dose may be prescribed and given at||
2580|065|H|least 4 hours after the first dose. Do not use more than 2 doses||
2580|066|H|to treat a seizure cluster episode.||
2580|067|H|   Do not use this product to treat episodes more often than once||
2580|068|H|every 5 days, or more than 5 times in a month. Doing so may make||
2580|069|H|this medication stop working well. Your child's seizures may get||
2580|070|H|worse or happen more often. Talk with the doctor if this||
2580|071|H|medication stops working well.||
2580|072|H|   Though it helps many people, this medication may sometimes||
2580|073|H|cause addiction. This risk may be higher if your child has a||
2580|074|H|substance use disorder (such as overuse of or addiction to||
2580|075|H|drugs/alcohol). Use this medication exactly as prescribed to||
2580|076|H|lower the risk of addiction. Ask the doctor or pharmacist for||
2580|077|H|more details.||
2580|078|H|   Get emergency help right away if your child's seizures last or||
2580|079|H|get worse after using the medication as directed, if you are||
2580|080|H|unable to give the medication, or if there is a change in your||
2580|081|H|child's breathing, coloring, behavior, or condition that alarms||
2580|082|H|you.||
2580|083|B|||
2580|084|S|SIDE EFFECTS:  See also Warning section.||
2580|085|S|   Drowsiness or headache may occur. If either of these effects||
2580|086|S|lasts or gets worse, tell the doctor or pharmacist promptly.||
2580|087|S|   Remember that this medication has been prescribed because the||
2580|088|S|doctor has judged that the benefit to your child is greater than||
2580|089|S|the risk of side effects. Many people using this medication do||
2580|090|S|not have serious side effects.||
2580|091|S|   Tell the doctor right away if your child has any serious side||
2580|092|S|effects, including: uncontrolled movements (such as||
2580|093|S|shaking/tremor).||
2580|094|S|   Get medical help right away if your child has any very serious||
2580|095|S|side effects, including: slow/shallow breathing, unusual||
2580|096|S|drowsiness/difficulty waking up.||
2580|097|S|   A small number of people who take anticonvulsants for any||
2580|098|S|condition (such as seizure, bipolar disorder, pain) may||
2580|099|S|experience depression, suicidal thoughts/attempts, or other||
2580|100|S|mental/mood problems. Tell the doctor right away if there are any||
2580|101|S|unusual/sudden changes in your child's mood, thoughts, or||
2580|102|S|behavior such as signs of depression, suicidal thoughts/attempts,||
2580|103|S|thoughts about harming themselves.||
2580|104|S|   A very serious allergic reaction to this drug is rare.||
2580|105|S|However, get medical help right away if you notice any symptoms||
2580|106|S|of a serious allergic reaction, including: rash, itching/swelling||
2580|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2580|108|S|breathing.||
2580|109|S|   This is not a complete list of possible side effects. If you||
2580|110|S|notice other effects not listed above, contact the doctor or||
2580|111|S|pharmacist.||
2580|112|S|   In the US -||
2580|113|S|   Call the doctor for medical advice about side effects. You may||
2580|114|S|report side effects to FDA at 1-800-FDA-1088 or at||
2580|115|S|www.fda.gov/medwatch.||
2580|116|S|   In Canada - Call the doctor for medical advice about side||
2580|117|S|effects. You may report side effects to Health Canada at||
2580|118|S|1-866-234-2345.||
2580|119|B|||
2580|120|P|PRECAUTIONS:  Before giving diazepam, tell the doctor or||
2580|121|P|pharmacist if your child is allergic to it; or to other||
2580|122|P|benzodiazepines (such as lorazepam); or if they have any other||
2580|123|P|allergies. This product may contain inactive ingredients which||
2580|124|P|can cause allergic reactions or other problems. Talk to the||
2580|125|P|pharmacist for more details.||
2580|126|P|   Before using this medication, tell the doctor or pharmacist||
2580|127|P|your child's medical history, especially of: glaucoma, breathing||
2580|128|P|problems (such as chronic obstructive lung disease-COPD, asthma),||
2580|129|P|mental/mood disorders (such as depression, thoughts of suicide,||
2580|130|P|psychosis).||
2580|131|P|   This drug may make your child feel dizzy or drowsy. Do not let||
2580|132|P|them ride a bicycle, drive, use machinery, or do anything that||
2580|133|P|needs alertness until your child can do it safely.||
2580|134|P|   Before having surgery, tell the doctor or dentist about all||
2580|135|P|the products your child uses (including prescription drugs,||
2580|136|P|nonprescription drugs, and herbal products).||
2580|137|P|   This medication is not usually used by adults. It is unlikely||
2580|138|P|to be used during pregnancy or breastfeeding. Consult the doctor||
2580|139|P|if you have any questions about this medication.||
2580|140|B|||
2580|141|I|DRUG INTERACTIONS:  See also Warning section.||
2580|142|I|   Drug interactions may change how your child's medications work||
2580|143|I|or increase their risk for serious side effects. This document||
2580|144|I|does not contain all possible drug interactions. Keep a list of||
2580|145|I|all the products your child uses (including||
2580|146|I|prescription/nonprescription drugs and herbal products) and share||
2580|147|I|it with the doctor and pharmacist. Do not start, stop, or change||
2580|148|I|the dosage of any medicines without the doctor's approval.||
2580|149|I|   A product that may interact with this drug is: sodium oxybate.||
2580|150|I|   The risk of serious side effects (such as slow/shallow||
2580|151|I|breathing, severe drowsiness/dizziness) may be increased if this||
2580|152|I|medication is used with other products that may also cause||
2580|153|I|drowsiness or breathing problems. Tell the doctor or pharmacist||
2580|154|I|if your child is using other products such as opioid pain or||
2580|155|I|cough relievers (such as codeine, hydrocodone), alcohol,||
2580|156|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
2580|157|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
2580|158|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
2580|159|I|cetirizine, diphenhydramine).||
2580|160|I|   Check the labels on all your child's medicines (such as||
2580|161|I|allergy or cough-and-cold products) because they may contain||
2580|162|I|ingredients that cause drowsiness. Ask the pharmacist about using||
2580|163|I|those products safely.||
2580|164|B|||
2580|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2580|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2580|167|O|poison control center right away. US residents can call||
2580|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2580|169|O|Symptoms of overdose may include: confusion, slow/shallow||
2580|170|O|breathing, coma.||
2580|171|B|||
2580|172|N|NOTES:  Do not share this medication with others. Sharing it is||
2580|173|N|against the law.||
2580|174|B|||
2580|175|D|MISSED DOSE:  Not applicable.||
2580|176|B|||
2580|177|R|STORAGE:  Store at room temperature away from light and moisture||
2580|178|R|in the foil packaging. Do not store in the bathroom. Keep all||
2580|179|R|medications away from children and pets.||
2580|180|R|   Do not flush medications down the toilet or pour them into a||
2580|181|R|drain unless instructed to do so. Properly discard this product||
2580|182|R|when it is expired or no longer needed. Consult the pharmacist or||
2580|183|R|local waste disposal company.||
2580|184|B|||
2580|185|M|MEDICAL ALERT:  Your child's condition can cause complications in||
2580|186|M|a medical emergency. For information about enrolling in||
2580|187|M|MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2580|188|B|||
2580|189|A|Information last revised May 2024.||
2580|190|A|Copyright(c) 2025 First Databank, Inc.||
2580|191|B|||
2581|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2581|002|Z|does NOT have all possible information about this product. This||
2581|003|Z|information does not assure that this product is safe, effective,||
2581|004|Z|or appropriate for you. This information is not individual||
2581|005|Z|medical advice and does not substitute for the advice of your||
2581|006|Z|health care professional. Always ask your health care||
2581|007|Z|professional for complete information about this product and your||
2581|008|Z|specific health needs.||
2581|009|B|||
2581|010|T|NOGAPENDEKIN ALFA INBAKICEPT - INTRAVESICAL||
2581|011|F|(noe-GAP-en-DE-kin AL-fa in-BAK-i-sept)||
2581|012|B|||
2581|013|C|COMMON BRAND NAME(S): Anktiva||
2581|014|B|||
2581|015|U|USES:  This medication is used in combination with another||
2581|016|U|medication (BCG) to treat certain types of bladder cancer. It||
2581|017|U|works by causing the body's defense system (immune system) to||
2581|018|U|become more active against bladder cancer cells.||
2581|019|U|   This medication may not cure your cancer. Delaying other||
2581|020|U|treatment (such as surgery) could lead to a more serious||
2581|021|U|condition (metastatic cancer). Discuss the risks and benefits of||
2581|022|U|this medication with your doctor.||
2581|023|B|||
2581|024|H|HOW TO USE:  This medication is given into the bladder through a||
2581|025|H|tube (catheter) by a health care professional. It is usually||
2581|026|H|given once weekly for 6 weeks during the first treatment cycle||
2581|027|H|and then less often thereafter as directed by your doctor.||
2581|028|H|Additional treatment cycles are given based on your medical||
2581|029|H|condition and response to treatment. Follow your doctor's||
2581|030|H|instructions carefully.||
2581|031|H|   The medication is left in the bladder for up to 2 hours and||
2581|032|H|then released by urinating. Since the urine contains medication,||
2581|033|H|you must sit down to urinate to avoid splashing of the urine.||
2581|034|H|   After you receive the medication, drink plenty of fluids||
2581|035|H|unless otherwise directed by your doctor. Doing so helps clear||
2581|036|H|the medication from your body.||
2581|037|H|   Use this medication regularly to get the most benefit from it.||
2581|038|H|To help you remember, mark your calendar with a reminder.||
2581|039|B|||
2581|040|S|SIDE EFFECTS:  Frequent urge to urinate or bladder irritation||
2581|041|S|with symptoms such as burning or pain may happen while you are||
2581|042|S|receiving the medication and when you first urinate. You may also||
2581|043|S|have pink/bloody urine up to 24 hours after you receive the||
2581|044|S|medication. Muscle/joint pain, fever, chills, nausea, or||
2581|045|S|tiredness may also occur. If any of these effects last or get||
2581|046|S|worse, tell your doctor or pharmacist promptly.||
2581|047|S|   Remember that this medication has been prescribed because your||
2581|048|S|doctor has judged that the benefit to you is greater than the||
2581|049|S|risk of side effects. Many people using this medication do not||
2581|050|S|have serious side effects.||
2581|051|S|   A very serious allergic reaction to this drug is rare.||
2581|052|S|However, get medical help right away if you notice any symptoms||
2581|053|S|of a serious allergic reaction, including: rash, itching/swelling||
2581|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2581|055|S|breathing.||
2581|056|S|   This is not a complete list of possible side effects. If you||
2581|057|S|notice other effects not listed above, contact your doctor or||
2581|058|S|pharmacist.||
2581|059|S|   In the US -||
2581|060|S|   Call your doctor for medical advice about side effects. You||
2581|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2581|062|S|www.fda.gov/medwatch.||
2581|063|S|   In Canada - Call your doctor for medical advice about side||
2581|064|S|effects. You may report side effects to Health Canada at||
2581|065|S|1-866-234-2345.||
2581|066|B|||
2581|067|P|PRECAUTIONS:  Before receiving this medication, tell your doctor||
2581|068|P|or pharmacist if you are allergic to it; or if you have any other||
2581|069|P|allergies. This product may contain inactive ingredients, which||
2581|070|P|can cause allergic reactions or other problems. Talk to your||
2581|071|P|pharmacist for more details.||
2581|072|P|   Before using this medication, tell your doctor or pharmacist||
2581|073|P|your medical history.||
2581|074|P|   Before having surgery, tell your doctor or dentist about all||
2581|075|P|the products you use (including prescription drugs,||
2581|076|P|nonprescription drugs, and herbal products).||
2581|077|P|   Tell your doctor if you are pregnant or plan to become||
2581|078|P|pregnant. You should not become pregnant while using this||
2581|079|P|medication. This medication may harm an unborn baby. Your doctor||
2581|080|P|should order a pregnancy test before you start this medication.||
2581|081|P|Ask about reliable forms of birth control while using this||
2581|082|P|medication and for 1 week after the last dose. If you become||
2581|083|P|pregnant, talk to your doctor right away about the risks and||
2581|084|P|benefits of this medication.||
2581|085|P|   It is unknown if this medication passes into breast milk.||
2581|086|P|Consult your doctor before breastfeeding.||
2581|087|B|||
2581|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2581|089|I|medications work or increase your risk for serious side effects.||
2581|090|I|This document does not contain all possible drug interactions.||
2581|091|I|Keep a list of all the products you use (including||
2581|092|I|prescription/nonprescription drugs and herbal products) and share||
2581|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
2581|094|I|the dosage of any medicines without your doctor's approval.||
2581|095|B|||
2581|096|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2581|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2581|098|O|poison control center right away. US residents can call||
2581|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2581|100|B|||
2581|101|N|NOTES:  Keep all medical and lab appointments.||
2581|102|B|||
2581|103|D|MISSED DOSE:  It is important to get each dose of this medication||
2581|104|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2581|105|D|right away for a new dosing schedule.||
2581|106|B|||
2581|107|R|STORAGE:  Not applicable. This medication is given in a hospital||
2581|108|R|or clinic and will not be stored at home.||
2581|109|B|||
2581|110|A|Information last revised October 2024.||
2581|111|A|Copyright(c) 2025 First Databank, Inc.||
2581|112|B|||
2582|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2582|002|Z|does NOT have all possible information about this product. This||
2582|003|Z|information does not assure that this product is safe, effective,||
2582|004|Z|or appropriate for you. This information is not individual||
2582|005|Z|medical advice and does not substitute for the advice of your||
2582|006|Z|health care professional. Always ask your health care||
2582|007|Z|professional for complete information about this product and your||
2582|008|Z|specific health needs.||
2582|009|B|||
2582|010|T|TOVORAFENIB - ORAL||
2582|011|B|||
2582|012|C|COMMON BRAND NAME(S): Ojemda||
2582|013|B|||
2582|014|U|USES:  This medication is used to treat a certain type of brain||
2582|015|U|tumor (pediatric low-grade glioma). Tovorafenib belongs to a||
2582|016|U|class of drugs known as kinase inhibitors. It works by slowing or||
2582|017|U|stopping the growth of tumor cells.||
2582|018|B|||
2582|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2582|020|H|from your pharmacist before you start taking tovorafenib and each||
2582|021|H|time you get a refill. If you have any questions, ask your doctor||
2582|022|H|or pharmacist.||
2582|023|H|   Take this medication by mouth with or without food as directed||
2582|024|H|by your doctor, usually once a week.||
2582|025|H|   If you are taking the tablet form of this medication, swallow||
2582|026|H|the tablets whole with water. Do not cut, crush, or chew the||
2582|027|H|tablets.||
2582|028|H|   If you are taking the liquid form of this medication, read the||
2582|029|H|Instructions for Use before you start taking this medication. If||
2582|030|H|you have any questions, ask your doctor or pharmacist. Carefully||
2582|031|H|follow the directions to mix the powder in the bottle with||
2582|032|H|room-temperature water before each dose. Do not use cold water.||
2582|033|H|Shake the bottle well for 60 seconds to mix the water with the||
2582|034|H|powder. After mixing, carefully measure the dose using the||
2582|035|H|provided special measuring device (oral syringe). Do not use a||
2582|036|H|household spoon because you may not get the correct dose. Do not||
2582|037|H|re-use the oral syringe. Use a new oral syringe for each dose. If||
2582|038|H|not used right away, the mixed medication may be stored at room||
2582|039|H|temperature for up to 15 minutes. After 15 minutes, throw away||
2582|040|H|any unused mixed medication.||
2582|041|H|   If you are giving this medication through a feeding tube, ask||
2582|042|H|your health care professional for detailed instructions on how to||
2582|043|H|properly mix and give it.||
2582|044|H|   The dosage is based on your medical condition, response to||
2582|045|H|treatment, and body size.||
2582|046|H|   If you vomit right after taking a dose, you may take another||
2582|047|H|dose.||
2582|048|H|   Take this medication regularly to get the most benefit from||
2582|049|H|it. To help you remember, take it on the same day each week.||
2582|050|H|   Do not increase your dose or use this drug more often or for||
2582|051|H|longer than prescribed. Your condition will not improve any||
2582|052|H|faster, and your risk of serious side effects will increase.||
2582|053|H|   Since this drug can be absorbed through the skin and lungs and||
2582|054|H|may harm an unborn baby, women who are pregnant or who may become||
2582|055|H|pregnant should not handle this medication or breathe the dust||
2582|056|H|from the tablets.||
2582|057|B|||
2582|058|S|SIDE EFFECTS:  Nausea, vomiting, tiredness, constipation,||
2582|059|S|headache, nosebleeds, dry skin, acne, or changes in hair color||
2582|060|S|may occur. If any of these effects last or get worse, tell your||
2582|061|S|doctor or pharmacist promptly.||
2582|062|S|   Remember that this medication has been prescribed because your||
2582|063|S|doctor has judged that the benefit to you is greater than the||
2582|064|S|risk of side effects. Many people using this medication do not||
2582|065|S|have serious side effects.||
2582|066|S|   Tell your doctor right away if you have any serious side||
2582|067|S|effects, including: signs of liver problems (such as||
2582|068|S|nausea/vomiting that doesn't stop, loss of appetite,||
2582|069|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
2582|070|S|bleeding/bruising, signs of infection (such as sore throat that||
2582|071|S|doesn't go away, fever, chills).||
2582|072|S|   Get medical help right away if you have any very serious side||
2582|073|S|effects, including: vomit that looks like coffee grounds, black||
2582|074|S|stools.||
2582|075|S|   Tovorafenib can commonly cause a rash that is usually not||
2582|076|S|serious. However, you may not be able to tell it apart from a||
2582|077|S|rare rash that could be a sign of a severe reaction. Get medical||
2582|078|S|help right away if you develop any rash.||
2582|079|S|   A very serious allergic reaction to this drug is rare.||
2582|080|S|However, get medical help right away if you notice any symptoms||
2582|081|S|of a serious allergic reaction, including: rash, itching/swelling||
2582|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2582|083|S|breathing.||
2582|084|S|   This is not a complete list of possible side effects. If you||
2582|085|S|notice other effects not listed above, contact your doctor or||
2582|086|S|pharmacist.||
2582|087|S|   In the US -||
2582|088|S|   Call your doctor for medical advice about side effects. You||
2582|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2582|090|S|www.fda.gov/medwatch.||
2582|091|S|   In Canada - Call your doctor for medical advice about side||
2582|092|S|effects. You may report side effects to Health Canada at||
2582|093|S|1-866-234-2345.||
2582|094|B|||
2582|095|P|PRECAUTIONS:  Before taking tovorafenib, tell your doctor or||
2582|096|P|pharmacist if you are allergic to it; or if you have any other||
2582|097|P|allergies. This product may contain inactive ingredients, which||
2582|098|P|can cause allergic reactions or other problems. Talk to your||
2582|099|P|pharmacist for more details.||
2582|100|P|   Before using this medication, tell your doctor or pharmacist||
2582|101|P|your medical history, especially of: liver problems.||
2582|102|P|   This medication may make you more sensitive to the sun. Limit||
2582|103|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2582|104|P|sunscreen and wear protective clothing when outdoors. Tell your||
2582|105|P|doctor right away if you get sunburned or have skin||
2582|106|P|blisters/redness. Your doctor may direct you to limit or avoid||
2582|107|P|phototherapy while you use this product. Ask your doctor for||
2582|108|P|details.||
2582|109|P|   Before having surgery, tell your doctor or dentist about all||
2582|110|P|the products you use (including prescription drugs,||
2582|111|P|nonprescription drugs, and herbal products).||
2582|112|P|   This medication may slow down a child's growth. Consult the||
2582|113|P|doctor or pharmacist for more details. See the doctor regularly||
2582|114|P|so your child's height and growth can be checked.||
2582|115|P|   Tell your doctor if you are pregnant or plan to become||
2582|116|P|pregnant. You should not become pregnant while using tovorafenib.||
2582|117|P|Tovorafenib may harm an unborn baby. Your doctor should order a||
2582|118|P|pregnancy test before you start this medication. Women using this||
2582|119|P|medication should ask about reliable forms of non-hormonal birth||
2582|120|P|control during treatment and for 28 days after the last dose. Men||
2582|121|P|using this medication should ask about reliable forms of birth||
2582|122|P|control during treatment and for 2 weeks after the last dose. If||
2582|123|P|you or your partner becomes pregnant, talk to your doctor right||
2582|124|P|away about the risks and benefits of this medication.||
2582|125|P|   Since this drug can be absorbed through the skin and lungs and||
2582|126|P|may harm an unborn baby, women who are pregnant or who may become||
2582|127|P|pregnant should not handle this medication or breathe the dust||
2582|128|P|from the tablets.||
2582|129|P|   It is unknown if this medication passes into breast milk.||
2582|130|P|Because of the possible risk to the infant, breastfeeding is not||
2582|131|P|recommended while using this medication and for 2 weeks after the||
2582|132|P|last dose. Consult your doctor before breastfeeding.||
2582|133|B|||
2582|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2582|135|I|medications work or increase your risk for serious side effects.||
2582|136|I|This document does not contain all possible drug interactions.||
2582|137|I|Keep a list of all the products you use (including||
2582|138|I|prescription/nonprescription drugs and herbal products) and share||
2582|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
2582|140|I|the dosage of any medicines without your doctor's approval.||
2582|141|I|   This medication can speed up the removal of other medications||
2582|142|I|from your body, which may affect how they work. Examples of||
2582|143|I|affected drugs include lonafarnib, mavacamten, revumenib, among||
2582|144|I|others.||
2582|145|I|   Other medications can affect the removal of tovorafenib from||
2582|146|I|your body, which may affect how tovorafenib works. Examples||
2582|147|I|include carbamazepine, clopidogrel, deferasirox, gemfibrozil,||
2582|148|I|ivosidenib, leflunomide, letermovir, mifepristone, pirtobrutinib,||
2582|149|I|rifampin, selpercatinib, teriflunomide, among others.||
2582|150|I|   This medication may decrease the effectiveness of hormonal||
2582|151|I|birth control such as pills, patch, or ring. This could cause||
2582|152|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2582|153|I|use reliable backup birth control methods while using this||
2582|154|I|medication. Also tell your doctor if you have any new spotting or||
2582|155|I|breakthrough bleeding, because these may be signs that your birth||
2582|156|I|control is not working well.||
2582|157|B|||
2582|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2582|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2582|160|O|poison control center right away. US residents can call||
2582|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2582|162|B|||
2582|163|N|NOTES:  Do not share this medication with others.||
2582|164|N|   Lab and/or medical tests (such as liver function) should be||
2582|165|N|done before you start taking this medication and while you are||
2582|166|N|taking it. Keep all medical and lab appointments. Consult your||
2582|167|N|doctor for more details.||
2582|168|B|||
2582|169|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2582|170|D|remember. If it is more than 3 days after the missed dose, skip||
2582|171|D|the missed dose. Take your next dose at the regular time. Do not||
2582|172|D|double the dose to catch up.||
2582|173|B|||
2582|174|R|STORAGE:  See also How to Use section.||
2582|175|R|   Store in the original container at room temperature away from||
2582|176|R|light and moisture. Do not store in the bathroom. Keep all||
2582|177|R|medications away from children and pets.||
2582|178|R|   Do not flush medications down the toilet or pour them into a||
2582|179|R|drain unless instructed to do so. Properly discard this product||
2582|180|R|when it is expired or no longer needed. Consult your pharmacist||
2582|181|R|or local waste disposal company.||
2582|182|B|||
2582|183|A|Information last revised March 2025.||
2582|184|A|Copyright(c) 2025 First Databank, Inc.||
2582|185|B|||
2583|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2583|002|Z|does NOT have all possible information about this product. This||
2583|003|Z|information does not assure that this product is safe, effective,||
2583|004|Z|or appropriate for you. This information is not individual||
2583|005|Z|medical advice and does not substitute for the advice of your||
2583|006|Z|health care professional. Always ask your health care||
2583|007|Z|professional for complete information about this product and your||
2583|008|Z|specific health needs.||
2583|009|B|||
2583|010|T|FIDANACOGENE ELAPARVOVEC - INJECTION||
2583|011|F|(FYE-da-NAK-oh-jeen EL-a-PAR-voe-vek)||
2583|012|B|||
2583|013|C|COMMON BRAND NAME(S): Beqvez||
2583|014|B|||
2583|015|U|USES:  This medication is used to treat a certain blood clotting||
2583|016|U|disease (hemophilia B). Hemophilia B is a genetic disorder caused||
2583|017|U|by lack of a certain type of clotting proteins (factor IX), or||
2583|018|U|caused by clotting proteins that do not work properly.||
2583|019|U|Fidanacogene elaparvovec is known as gene therapy. It is made||
2583|020|U|from a virus that has been specially prepared. The virus is used||
2583|021|U|to carry a working copy of the factor IX gene into your cells.||
2583|022|U|This effect may help your body make normal factor IX and may||
2583|023|U|decrease bleeding problems due to hemophilia B.||
2583|024|B|||
2583|025|H|HOW TO USE:  This medication is given by slow injection into a||
2583|026|H|vein as directed by the doctor. It is given as a one-time dose.||
2583|027|H|The dosage is based on your body weight.||
2583|028|H|   Infusion reactions may happen during the infusion of this drug||
2583|029|H|and for some time afterward. Tell your doctor right away if you||
2583|030|H|have any symptoms of infusion reactions such as fever, chills,||
2583|031|H|fast heartbeat, nausea, vomiting, or headache. Your doctor may||
2583|032|H|give you other medications to help with these side effects or may||
2583|033|H|slow down or stop your treatment for some time.||
2583|034|H|   Small amounts of virus may shed in your bodily fluids (such as||
2583|035|H|urine, stool, saliva, mucus, or semen) for 6 months after your||
2583|036|H|treatment. During this time, if you or your caregiver may have||
2583|037|H|touched any bodily fluids that could contain virus, wash your||
2583|038|H|hands with soap and water to avoid infection. Talk to your doctor||
2583|039|H|about other important things you should do to prevent infection.||
2583|040|B|||
2583|041|S|SIDE EFFECTS:  See also How to Use section.||
2583|042|S|   Remember that this medication has been prescribed because your||
2583|043|S|doctor has judged that the benefit to you is greater than the||
2583|044|S|risk of side effects. Many people using this medication do not||
2583|045|S|have serious side effects.||
2583|046|S|   This medication may rarely cause serious liver disease. Tell||
2583|047|S|your doctor right away if you have any symptoms of liver||
2583|048|S|problems, such as: nausea/vomiting that doesn't stop, loss of||
2583|049|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2583|050|S|urine.||
2583|051|S|   A very serious allergic reaction to this drug is rare.||
2583|052|S|However, get medical help right away if you notice any symptoms||
2583|053|S|of a serious allergic reaction, including: rash, itching/swelling||
2583|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2583|055|S|breathing.||
2583|056|S|   This is not a complete list of possible side effects. If you||
2583|057|S|notice other effects not listed above, contact your doctor or||
2583|058|S|pharmacist.||
2583|059|S|   In the US -||
2583|060|S|   Call your doctor for medical advice about side effects. You||
2583|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2583|062|S|www.fda.gov/medwatch.||
2583|063|S|   In Canada - Call your doctor for medical advice about side||
2583|064|S|effects. You may report side effects to Health Canada at||
2583|065|S|1-866-234-2345.||
2583|066|B|||
2583|067|P|PRECAUTIONS:  Before receiving fidanacogene elaparvovec, tell||
2583|068|P|your doctor or pharmacist if you are allergic to it; or if you||
2583|069|P|have any other allergies. This product may contain inactive||
2583|070|P|ingredients, which can cause allergic reactions or other||
2583|071|P|problems. Talk to your pharmacist for more details.||
2583|072|P|   Before using this medication, tell your doctor or pharmacist||
2583|073|P|your medical history, especially of: alcohol use, current||
2583|074|P|infection (such as hepatitis B or C, HIV infection), liver||
2583|075|P|problems (including cirrhosis, fatty liver disease, liver||
2583|076|P|fibrosis).||
2583|077|P|   Use of alcohol after receiving this treatment may increase||
2583|078|P|your risk for liver problems. Limit alcohol for at least 1 year||
2583|079|P|after you receive this treatment. Consult your doctor or||
2583|080|P|pharmacist for more information.||
2583|081|P|   Before having surgery, tell your doctor or dentist about all||
2583|082|P|the products you use (including prescription drugs,||
2583|083|P|nonprescription drugs, and herbal products).||
2583|084|P|   This medication is not usually used by women. It is unlikely||
2583|085|P|to be used during pregnancy or breastfeeding. Consult your doctor||
2583|086|P|if you have any questions about this medication.||
2583|087|P|   Men should use reliable forms of birth control for 6 months||
2583|088|P|after treatment. If your partner becomes pregnant or thinks she||
2583|089|P|may be pregnant, tell the doctor right away. Do not donate sperm||
2583|090|P|for 6 months after treatment.||
2583|091|B|||
2583|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2583|093|I|medications work or increase your risk for serious side effects.||
2583|094|I|This document does not contain all possible drug interactions.||
2583|095|I|Keep a list of all the products you use (including||
2583|096|I|prescription/nonprescription drugs and herbal products) and share||
2583|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
2583|098|I|the dosage of any medicines without your doctor's approval.||
2583|099|B|||
2583|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2583|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2583|102|O|poison control center right away. US residents can call||
2583|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2583|104|B|||
2583|105|N|NOTES:  Lab and/or medical tests (such as liver function, factor||
2583|106|N|IX activity and inhibitor levels) must be done before you start||
2583|107|N|receiving this treatment and after you receive it. Keep all||
2583|108|N|medical and lab appointments. Consult your doctor for more||
2583|109|N|details.||
2583|110|N|   After receiving this treatment, do not donate blood, organs,||
2583|111|N|tissues, or cells.||
2583|112|B|||
2583|113|D|MISSED DOSE:  Not applicable.||
2583|114|B|||
2583|115|R|STORAGE:  Not applicable. This type of product is given in a||
2583|116|R|hospital or clinic and will not be stored at home.||
2583|117|B|||
2583|118|M|MEDICAL ALERT:  Your condition can cause complications in a||
2583|119|M|medical emergency. For information about enrolling in MedicAlert,||
2583|120|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2583|121|B|||
2583|122|A|Information last revised July 2025.||
2583|123|A|Copyright(c) 2025 First Databank, Inc.||
2583|124|B|||
2584|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2584|002|Z|does NOT have all possible information about this product. This||
2584|003|Z|information does not assure that this product is safe, effective,||
2584|004|Z|or appropriate for you. This information is not individual||
2584|005|Z|medical advice and does not substitute for the advice of your||
2584|006|Z|health care professional. Always ask your health care||
2584|007|Z|professional for complete information about this product and your||
2584|008|Z|specific health needs.||
2584|009|B|||
2584|010|T|VALBENAZINE SPRINKLE CAPSULE - ORAL||
2584|011|F|(val-BEN-a-zeen)||
2584|012|B|||
2584|013|C|COMMON BRAND NAME(S): Ingrezza Sprinkle||
2584|014|B|||
2584|015|W|WARNING:  If you have Huntington's disease, valbenazine can||
2584|016|W|sometimes increase the risk of depression and suicidal||
2584|017|W|thoughts/attempts. People with Huntington's disease are already||
2584|018|W|more likely to have depression and suicidal thoughts/attempts.||
2584|019|W|Talk with your doctor about the risks and benefits of this||
2584|020|W|medication. Tell your doctor right away if you or your||
2584|021|W|family/caregivers notice that you have new/worsening symptoms of||
2584|022|W|depression, sadness, loss of interest in activities you used to||
2584|023|W|enjoy, suicidal thoughts/attempts, or other mental/mood/behavior||
2584|024|W|changes (such as new/worsening anxiety, panic attacks, trouble||
2584|025|W|sleeping, irritability, hostile/angry feelings).||
2584|026|B|||
2584|027|U|USES:  Valbenazine is used to treat involuntary movements of the||
2584|028|U|face, tongue, or other body parts (tardive dyskinesia). This||
2584|029|U|medication is also used to decrease the involuntary movements||
2584|030|U|(chorea) caused by Huntington's disease. Reducing involuntary||
2584|031|U|movements will help you take part in more of your normal daily||
2584|032|U|activities. This medication is thought to work by decreasing the||
2584|033|U|amount of certain natural substances in the brain that affect how||
2584|034|U|your nerves and muscles work (monoamines such as dopamine,||
2584|035|U|serotonin, and norepinephrine).||
2584|036|B|||
2584|037|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2584|038|H|provided by your pharmacist before you start using valbenazine||
2584|039|H|and each time you get a refill. If you have any questions, ask||
2584|040|H|your doctor or pharmacist.||
2584|041|H|   Take this medication by mouth with or without food as directed||
2584|042|H|by your doctor, usually once daily. You may swallow this||
2584|043|H|medication whole, or you may open the capsule and sprinkle the||
2584|044|H|contents over 1 teaspoon (5 milliliters) of soft food such as||
2584|045|H|applesauce, yogurt, or pudding. Do not add the contents to milk||
2584|046|H|or water. Stir and swallow all of the mixture right away without||
2584|047|H|chewing or crushing. Then drink a glass of water (8 ounces/240||
2584|048|H|milliliters) to make sure you have swallowed all of your dose.||
2584|049|H|Throw away any unused mixture after 2 hours. Do not prepare a||
2584|050|H|supply in advance or give this mixture through a feeding tube.||
2584|051|H|   To reduce your risk of side effects, your doctor may direct||
2584|052|H|you to start this medication at a low dose and gradually increase||
2584|053|H|your dose. Follow your doctor's instructions carefully.||
2584|054|H|   The dosage is based on your medical condition, response to||
2584|055|H|treatment, and other medications you may be taking. Be sure to||
2584|056|H|tell your doctor and pharmacist about all the products you use||
2584|057|H|(including prescription drugs, nonprescription drugs, and herbal||
2584|058|H|products).||
2584|059|H|   Take this medication regularly to get the most benefit from||
2584|060|H|it. To help you remember, take it at the same time each day.||
2584|061|H|   Tell your doctor if your condition does not get better or if||
2584|062|H|it gets worse.||
2584|063|B|||
2584|064|S|SIDE EFFECTS:  See also Warning section.||
2584|065|S|   Drowsiness, dizziness, restlessness, or vomiting may occur. If||
2584|066|S|any of these effects last or get worse, tell your doctor or||
2584|067|S|pharmacist promptly.||
2584|068|S|   To reduce the risk of dizziness and lightheadedness, get up||
2584|069|S|slowly when rising from a sitting or lying position.||
2584|070|S|   Remember that this medication has been prescribed because your||
2584|071|S|doctor has judged that the benefit to you is greater than the||
2584|072|S|risk of side effects. Many people using this medication do not||
2584|073|S|have serious side effects.||
2584|074|S|   Sometimes valbenazine can cause side effects that are similar||
2584|075|S|to the symptoms of worsening Huntington's disease. Your doctor||
2584|076|S|may need to adjust your dose to see if these side effects are due||
2584|077|S|to the drug or to the disease. Tell your doctor right away if any||
2584|078|S|of these serious side effects occur: shaking/tremors, slowed||
2584|079|S|movement, loss of balance, trouble swallowing.||
2584|080|S|   This medication may rarely cause a very serious condition||
2584|081|S|called neuroleptic malignant syndrome (NMS). Get medical help||
2584|082|S|right away if you have any of the following symptoms: fever,||
2584|083|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
2584|084|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
2584|085|S|signs of kidney problems (such as change in the amount of urine).||
2584|086|S|   A very serious allergic reaction to this drug is rare.||
2584|087|S|However, get medical help right away if you notice any symptoms||
2584|088|S|of a serious allergic reaction, including: rash, itching/swelling||
2584|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2584|090|S|breathing.||
2584|091|S|   This is not a complete list of possible side effects. If you||
2584|092|S|notice other effects not listed above, contact your doctor or||
2584|093|S|pharmacist.||
2584|094|S|   In the US -||
2584|095|S|   Call your doctor for medical advice about side effects. You||
2584|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2584|097|S|www.fda.gov/medwatch.||
2584|098|S|   In Canada - Call your doctor for medical advice about side||
2584|099|S|effects. You may report side effects to Health Canada at||
2584|100|S|1-866-234-2345.||
2584|101|B|||
2584|102|P|PRECAUTIONS:  See also Warning section.||
2584|103|P|   Before taking valbenazine, tell your doctor or pharmacist if||
2584|104|P|you are allergic to it; or if you have any other allergies. This||
2584|105|P|product may contain inactive ingredients, which can cause||
2584|106|P|allergic reactions or other problems. Talk to your pharmacist for||
2584|107|P|more details.||
2584|108|P|   Before using this medication, tell your doctor or pharmacist||
2584|109|P|your medical history, especially of: liver problems.||
2584|110|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2584|111|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2584|112|P|machinery, or do anything that needs alertness until you can do||
2584|113|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2584|114|P|are using marijuana (cannabis).||
2584|115|P|   Valbenazine may cause a condition that affects the heart||
2584|116|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2584|117|P|serious (rarely fatal) fast/irregular heartbeat and other||
2584|118|P|symptoms (such as severe dizziness, fainting) that need medical||
2584|119|P|attention right away.||
2584|120|P|   The risk of QT prolongation may be increased if you have||
2584|121|P|certain medical conditions or are taking other drugs that may||
2584|122|P|cause QT prolongation. Before using valbenazine, tell your doctor||
2584|123|P|or pharmacist of all the drugs you take and if you have any of||
2584|124|P|the following conditions: certain heart problems (heart failure,||
2584|125|P|slow heartbeat, QT prolongation in the EKG), family history of||
2584|126|P|certain heart problems (QT prolongation in the EKG, sudden||
2584|127|P|cardiac death).||
2584|128|P|   Low levels of potassium or magnesium in the blood may also||
2584|129|P|increase your risk of QT prolongation. This risk may increase if||
2584|130|P|you use certain drugs (such as diuretics/"water pills") or if you||
2584|131|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2584|132|P|Talk to your doctor about using valbenazine safely.||
2584|133|P|   Before having surgery, tell your doctor or dentist about all||
2584|134|P|the products you use (including prescription drugs,||
2584|135|P|nonprescription drugs, and herbal products).||
2584|136|P|   Older adults may be more sensitive to the side effects of this||
2584|137|P|drug, especially QT prolongation (see above).||
2584|138|P|   During pregnancy, this medication should be used only when||
2584|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
2584|140|P|   It is unknown if this drug passes into breast milk.||
2584|141|P|Breastfeeding is not recommended while using this drug and for 5||
2584|142|P|days after the last dose. Consult your doctor before||
2584|143|P|breastfeeding.||
2584|144|B|||
2584|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2584|146|I|medications work or increase your risk for serious side effects.||
2584|147|I|This document does not contain all possible drug interactions.||
2584|148|I|Keep a list of all the products you use (including||
2584|149|I|prescription/nonprescription drugs and herbal products) and share||
2584|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
2584|151|I|the dosage of any medicines without your doctor's approval.||
2584|152|I|   Some products that may interact with this drug are:||
2584|153|I|deutetrabenazine, tetrabenazine.||
2584|154|I|   Other medications can affect the removal of valbenazine from||
2584|155|I|your body, which may affect how valbenazine works. Examples||
2584|156|I|include rifamycins (such as rifabutin, rifampin), drugs used to||
2584|157|I|treat seizures (such as carbamazepine, phenytoin), St. John's||
2584|158|I|wort, among others.||
2584|159|I|   Taking MAO inhibitors with this medication may cause a serious||
2584|160|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
2584|161|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2584|162|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2584|163|I|selegiline, tranylcypromine) during treatment with this||
2584|164|I|medication. Most MAO inhibitors should also not be taken for two||
2584|165|I|weeks before and after treatment with this medication. Ask your||
2584|166|I|doctor when to start or stop taking this medication.||
2584|167|B|||
2584|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2584|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2584|170|O|poison control center right away. US residents can call||
2584|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2584|172|B|||
2584|173|N|NOTES:  Do not share this medication with others.||
2584|174|B|||
2584|175|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2584|176|D|remember. If it is near the time of the next dose, skip the||
2584|177|D|missed dose. Take your next dose at the regular time. Do not||
2584|178|D|double the dose to catch up.||
2584|179|B|||
2584|180|R|STORAGE:  Store at room temperature away from light and moisture.||
2584|181|R|Do not store in the bathroom. Keep all medications away from||
2584|182|R|children and pets.||
2584|183|R|   Do not flush medications down the toilet or pour them into a||
2584|184|R|drain unless instructed to do so. Properly discard this product||
2584|185|R|when it is expired or no longer needed. Consult your pharmacist||
2584|186|R|or local waste disposal company.||
2584|187|B|||
2584|188|A|Information last revised May 2024.||
2584|189|A|Copyright(c) 2025 First Databank, Inc.||
2584|190|B|||
2585|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2585|002|Z|does NOT have all possible information about this product. This||
2585|003|Z|information does not assure that this product is safe, effective,||
2585|004|Z|or appropriate for you. This information is not individual||
2585|005|Z|medical advice and does not substitute for the advice of your||
2585|006|Z|health care professional. Always ask your health care||
2585|007|Z|professional for complete information about this product and your||
2585|008|Z|specific health needs.||
2585|009|B|||
2585|010|T|ELOSULFASE ALFA - INJECTION||
2585|011|F|(EL-oh-SUL-fase AL-fa)||
2585|012|B|||
2585|013|C|COMMON BRAND NAME(S): Vimizim||
2585|014|B|||
2585|015|W|WARNING:  Elosulfase alfa may rarely cause serious (sometimes||
2585|016|W|fatal) allergic reactions during the infusion of this drug. A||
2585|017|W|health care professional will monitor you closely during and||
2585|018|W|after your infusion. Your doctor may prescribe other medications||
2585|019|W|(such as antihistamines) to help prevent these side effects. Get||
2585|020|W|medical help right away if you have any symptoms of a serious||
2585|021|W|allergic reaction such as cough, chest pain, bluish||
2585|022|W|fingers/toes/lips, rash, itching/swelling (especially of the||
2585|023|W|face/tongue/throat), severe dizziness, trouble breathing, or||
2585|024|W|shortness of breath. Your doctor may give you other medications||
2585|025|W|to help with these side effects or may slow down or stop your||
2585|026|W|treatment for some time.||
2585|027|W|   Before you start your infusion, tell your doctor if you have||
2585|028|W|breathing problems or a fever. Breathing problems may get worse||
2585|029|W|during the infusion. Your doctor may delay your infusion or||
2585|030|W|monitor you for longer periods after your infusion.||
2585|031|B|||
2585|032|U|USES:  Elosulfase alfa is used to treat a certain inherited||
2585|033|U|condition (mucopolysaccharidosis type IVA-Morquio A syndrome)||
2585|034|U|that causes a buildup of certain substances||
2585|035|U|(glycosaminoglycans-GAGs) in the body. Elosulfase alfa works by||
2585|036|U|breaking down GAGs in the body.||
2585|037|B|||
2585|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2585|039|H|from your pharmacist before you start using elosulfase alfa and||
2585|040|H|each time you get an infusion. If you have any questions, ask||
2585|041|H|your doctor or pharmacist.||
2585|042|H|   This medication is given by injection into a vein by a health||
2585|043|H|care professional. It is given as directed by your doctor,||
2585|044|H|usually once a week. The dosage and treatment schedule are based||
2585|045|H|on your medical condition, weight, and response to treatment.||
2585|046|H|   Infusion reactions may happen during the infusion of this||
2585|047|H|drug. Your doctor may prescribe other medications before each||
2585|048|H|treatment to help prevent these side effects. Tell your doctor||
2585|049|H|right away if you have any symptoms of infusion reactions such as||
2585|050|H|headache, abdominal pain, flushing, fever, chills, tiredness,||
2585|051|H|nausea, or vomiting. Your doctor may give you other medications||
2585|052|H|to help with these side effects or may slow down or stop your||
2585|053|H|treatment for some time. See also Warning section.||
2585|054|H|   Use this medication regularly to get the most benefit from it.||
2585|055|H|To help you remember, mark your calendar with a reminder.||
2585|056|H|   Tell your doctor if your condition gets worse.||
2585|057|B|||
2585|058|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2585|059|S|   Remember that this medication has been prescribed because your||
2585|060|S|doctor has judged that the benefit to you is greater than the||
2585|061|S|risk of side effects. Many people using this medication do not||
2585|062|S|have serious side effects.||
2585|063|S|   A very serious allergic reaction to this drug is rare.||
2585|064|S|However, get medical help right away if you notice any symptoms||
2585|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2585|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2585|067|S|breathing.||
2585|068|S|   This is not a complete list of possible side effects. If you||
2585|069|S|notice other effects not listed above, contact your doctor or||
2585|070|S|pharmacist.||
2585|071|S|   In the US -||
2585|072|S|   Call your doctor for medical advice about side effects. You||
2585|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2585|074|S|www.fda.gov/medwatch.||
2585|075|S|   In Canada - Call your doctor for medical advice about side||
2585|076|S|effects. You may report side effects to Health Canada at||
2585|077|S|1-866-234-2345.||
2585|078|B|||
2585|079|P|PRECAUTIONS:  See also Warning section.||
2585|080|P|   Before using elosulfase alfa, tell your doctor or pharmacist||
2585|081|P|if you are allergic to it; or if you have any other allergies.||
2585|082|P|This product may contain inactive ingredients, which can cause||
2585|083|P|allergic reactions or other problems. Talk to your pharmacist for||
2585|084|P|more details.||
2585|085|P|   Before using this medication, tell your doctor or pharmacist||
2585|086|P|your medical history.||
2585|087|P|   Before having surgery, tell your doctor or dentist about all||
2585|088|P|the products you use (including prescription drugs,||
2585|089|P|nonprescription drugs, and herbal products).||
2585|090|P|   During pregnancy, this medication should be used only when||
2585|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
2585|092|P|   It is unknown if this medication passes into breast milk.||
2585|093|P|Consult your doctor before breastfeeding.||
2585|094|B|||
2585|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2585|096|I|medications work or increase your risk for serious side effects.||
2585|097|I|This document does not contain all possible drug interactions.||
2585|098|I|Keep a list of all the products you use (including||
2585|099|I|prescription/nonprescription drugs and herbal products) and share||
2585|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
2585|101|I|the dosage of any medicines without your doctor's approval.||
2585|102|B|||
2585|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2585|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2585|105|O|poison control center right away. US residents can call||
2585|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2585|107|B|||
2585|108|N|NOTES:  Keep all medical and lab appointments.||
2585|109|B|||
2585|110|D|MISSED DOSE:  It is important to get each dose of this medication||
2585|111|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2585|112|D|right away for a new dosing schedule.||
2585|113|B|||
2585|114|R|STORAGE:  Not applicable. This medication is given in a hospital||
2585|115|R|or clinic or doctor's office and will not be stored at home.||
2585|116|B|||
2585|117|A|Information last revised October 2024.||
2585|118|A|Copyright(c) 2025 First Databank, Inc.||
2585|119|B|||
2586|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2586|002|Z|does NOT have all possible information about this product. This||
2586|003|Z|information does not assure that this product is safe, effective,||
2586|004|Z|or appropriate for you. This information is not individual||
2586|005|Z|medical advice and does not substitute for the advice of your||
2586|006|Z|health care professional. Always ask your health care||
2586|007|Z|professional for complete information about this product and your||
2586|008|Z|specific health needs.||
2586|009|B|||
2586|010|T|TARLATAMAB - INJECTION||
2586|011|B|||
2586|012|C|COMMON BRAND NAME(S): Imdelltra||
2586|013|B|||
2586|014|W|WARNING:  Tarlatamab may cause a certain serious (even fatal)||
2586|015|W|side effect known as cytokine release syndrome-CRS. Careful||
2586|016|W|monitoring and prompt treatment may decrease your risk. Get||
2586|017|W|medical help right away if you have symptoms such as fever,||
2586|018|W|chills, headache, fast heartbeat, trouble breathing,||
2586|019|W|nausea/vomiting, or dizziness/lightheadedness.||
2586|020|W|   This medication can also cause serious (even fatal) nervous||
2586|021|W|system problems. Tell your doctor right away if you have any||
2586|022|W|symptoms such as confusion, drowsiness, numbness/tingling of||
2586|023|W|arms/legs, mental/mood changes, trouble sleeping, shaking, loss||
2586|024|W|of balance, trouble speaking and understanding, or seizures.||
2586|025|B|||
2586|026|U|USES:  This medication is used to treat a certain type of cancer||
2586|027|U|(extensive stage small cell lung cancer - ES-SCLC). Tarlatamab||
2586|028|U|works by slowing or stopping the growth of cancer cells.||
2586|029|B|||
2586|030|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2586|031|H|Patient Information Leaflet provided by your pharmacist before||
2586|032|H|you start using tarlatamab and each time you get a treatment. If||
2586|033|H|you have any questions, ask your doctor or pharmacist.||
2586|034|H|   This medication is given by a health care professional. It is||
2586|035|H|injected slowly into a vein over 1 hour. To reduce your risk of||
2586|036|H|side effects, your doctor will start this medication at a low||
2586|037|H|dose and gradually increase your dose. These starting doses are||
2586|038|H|part of a "step-up dosing schedule." Your doctor will monitor you||
2586|039|H|for some time after each dose to help you manage any side||
2586|040|H|effects. When you get your first two "step-up dose" infusions,||
2586|041|H|for 48 hours after each infusion begins, you and your caregiver||
2586|042|H|should stay within a 1-hour drive of a health care facility (for||
2586|043|H|example, a hospital).||
2586|044|H|   Before you receive this medication, your doctor will prescribe||
2586|045|H|other medications (such as dexamethasone) to help prevent side||
2586|046|H|effects. Carefully follow your doctor's directions for all your||
2586|047|H|medications.||
2586|048|B|||
2586|049|S|SIDE EFFECTS:  See also Warning section.||
2586|050|S|   Tiredness, changes in sense of taste, muscle/joint pain, loss||
2586|051|S|of appetite, or constipation may occur. If any of these effects||
2586|052|S|last or get worse, tell your doctor or pharmacist promptly.||
2586|053|S|   People using this medication may have serious side effects.||
2586|054|S|However, you have been prescribed this drug because your doctor||
2586|055|S|has judged that the benefit to you is greater than the risk of||
2586|056|S|side effects. Careful monitoring by your doctor may decrease your||
2586|057|S|risk.||
2586|058|S|   Tell your doctor right away if you have any serious side||
2586|059|S|effects, including: easy bruising/bleeding, signs of liver||
2586|060|S|disease (such as nausea/vomiting that doesn't stop,||
2586|061|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2586|062|S|of anemia (such as unusual tiredness, pale skin).||
2586|063|S|   This medication may lower your ability to fight infections.||
2586|064|S|This may make you more likely to get a serious (rarely fatal)||
2586|065|S|infection or make any infection you have worse. Tell your doctor||
2586|066|S|right away if you have any signs of infection (such as sore||
2586|067|S|throat that doesn't go away, fever, chills).||
2586|068|S|   A very serious allergic reaction to this drug is rare.||
2586|069|S|However, get medical help right away if you notice any symptoms||
2586|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2586|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2586|072|S|breathing.||
2586|073|S|   This is not a complete list of possible side effects. If you||
2586|074|S|notice other effects not listed above, contact your doctor or||
2586|075|S|pharmacist.||
2586|076|S|   In the US -||
2586|077|S|   Call your doctor for medical advice about side effects. You||
2586|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2586|079|S|www.fda.gov/medwatch.||
2586|080|S|   In Canada - Call your doctor for medical advice about side||
2586|081|S|effects. You may report side effects to Health Canada at||
2586|082|S|1-866-234-2345.||
2586|083|B|||
2586|084|P|PRECAUTIONS:  Before using tarlatamab, tell your doctor or||
2586|085|P|pharmacist if you are allergic to it; or if you have any other||
2586|086|P|allergies. This product may contain inactive ingredients, which||
2586|087|P|can cause allergic reactions or other problems. Talk to your||
2586|088|P|pharmacist for more details.||
2586|089|P|   Before using this medication, tell your doctor or pharmacist||
2586|090|P|your medical history, especially of: current/recent infections.||
2586|091|P|   This drug may make you dizzy or drowsy or affect your thinking||
2586|092|P|and coordination. Alcohol or marijuana (cannabis) can worsen||
2586|093|P|these effects. Do not drive, use machinery, or do anything that||
2586|094|P|needs alertness until you can do it safely. Limit alcoholic||
2586|095|P|beverages. Talk to your doctor if you are using marijuana||
2586|096|P|(cannabis).||
2586|097|P|   This medication can make you more likely to get infections or||
2586|098|P|may make current infections worse. Stay away from anyone who has||
2586|099|P|an infection that may easily spread (such as chickenpox,||
2586|100|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2586|101|P|exposed to an infection or for more details.||
2586|102|P|   Tell your health care professional that you are using||
2586|103|P|tarlatamab before having any immunizations/vaccinations. Avoid||
2586|104|P|contact with people who have recently received live vaccines||
2586|105|P|(such as flu vaccine inhaled through the nose).||
2586|106|P|   To lower the chance of getting cut, bruised, or injured, use||
2586|107|P|caution with sharp objects like razors and nail cutters, and||
2586|108|P|avoid activities such as contact sports.||
2586|109|P|   Before having surgery, tell your doctor or dentist about all||
2586|110|P|the products you use (including prescription drugs,||
2586|111|P|nonprescription drugs, and herbal products).||
2586|112|P|   Tell your doctor if you are pregnant or plan to become||
2586|113|P|pregnant. You should not become pregnant while using tarlatamab.||
2586|114|P|Tarlatamab may harm an unborn baby. Your doctor should order a||
2586|115|P|pregnancy test before you start this medication. Ask about||
2586|116|P|reliable forms of birth control while using this medication and||
2586|117|P|for 2 months after the last dose. If you become pregnant, talk to||
2586|118|P|your doctor right away about the risks and benefits of this||
2586|119|P|medication.||
2586|120|P|   It is unknown if this drug passes into breast milk. Because of||
2586|121|P|the possible risk to the infant, breastfeeding is not recommended||
2586|122|P|while using this drug and for 2 months after the last dose.||
2586|123|P|Consult your doctor before breastfeeding.||
2586|124|B|||
2586|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2586|126|I|medications work or increase your risk for serious side effects.||
2586|127|I|This document does not contain all possible drug interactions.||
2586|128|I|Keep a list of all the products you use (including||
2586|129|I|prescription/nonprescription drugs and herbal products) and share||
2586|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
2586|131|I|the dosage of any medicines without your doctor's approval.||
2586|132|B|||
2586|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2586|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2586|135|O|poison control center right away. US residents can call||
2586|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2586|137|B|||
2586|138|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2586|139|N|liver function) should be done before you start using this||
2586|140|N|medication and while you are using it. Keep all medical and lab||
2586|141|N|appointments. Consult your doctor for more details.||
2586|142|B|||
2586|143|D|MISSED DOSE:  It is important to get each dose of this medication||
2586|144|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2586|145|D|right away for a new dosing schedule.||
2586|146|B|||
2586|147|R|STORAGE:  Not applicable. This medication is given in a hospital||
2586|148|R|or clinic and will not be stored at home.||
2586|149|B|||
2586|150|M|MEDICAL ALERT:  Your condition can cause complications in a||
2586|151|M|medical emergency. For information about enrolling in MedicAlert,||
2586|152|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2586|153|B|||
2586|154|A|Information last revised April 2025.||
2586|155|A|Copyright(c) 2025 First Databank, Inc.||
2586|156|B|||
2587|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2587|002|Z|does NOT have all possible information about this product. This||
2587|003|Z|information does not assure that this product is safe, effective,||
2587|004|Z|or appropriate for you. This information is not individual||
2587|005|Z|medical advice and does not substitute for the advice of your||
2587|006|Z|health care professional. Always ask your health care||
2587|007|Z|professional for complete information about this product and your||
2587|008|Z|specific health needs.||
2587|009|B|||
2587|010|T|LACOSAMIDE EXTENDED-RELEASE - ORAL||
2587|011|F|(la-KOE-sa-mide)||
2587|012|B|||
2587|013|C|COMMON BRAND NAME(S): Motpoly XR||
2587|014|B|||
2587|015|U|USES:  Lacosamide is used to prevent and control seizures. It is||
2587|016|U|an anticonvulsant or antiepileptic drug. It works by reducing the||
2587|017|U|spread of seizure activity in the brain.||
2587|018|B|||
2587|019|H|HOW TO USE:  Read the Medication Guide provided by your||
2587|020|H|pharmacist before you start taking lacosamide and each time you||
2587|021|H|get a refill. If you have any questions, ask your doctor or||
2587|022|H|pharmacist.||
2587|023|H|   Take this medication by mouth with or without food as directed||
2587|024|H|by your doctor, usually once daily. Swallow the capsules whole.||
2587|025|H|Do not open, crush, or chew the capsules. Doing so can release||
2587|026|H|all of the drug at once, increasing the risk of side effects.||
2587|027|H|   The dosage is based on your medical condition and response to||
2587|028|H|treatment. Children's dosage is also based on weight. To reduce||
2587|029|H|your risk of side effects, your doctor may direct you to start||
2587|030|H|this medication at a low dose and gradually increase your dose.||
2587|031|H|Follow your doctor's instructions carefully.||
2587|032|H|   This medication works best when the amount of drug in your||
2587|033|H|body is kept at a constant level. Take this drug at evenly spaced||
2587|034|H|times. To help you remember, take it at the same time each day.||
2587|035|H|   Do not stop taking this medication without consulting your||
2587|036|H|doctor. Seizures may become worse when the drug is suddenly||
2587|037|H|stopped. Your dose may need to be gradually decreased. Consult||
2587|038|H|your doctor or pharmacist for more details.||
2587|039|H|   Though it helps many people, this medication may sometimes||
2587|040|H|cause addiction. This risk may be higher if you have a substance||
2587|041|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
2587|042|H|Take this medication exactly as prescribed to lower the risk of||
2587|043|H|addiction. Ask your doctor or pharmacist for more details.||
2587|044|H|   Tell your doctor right away if your seizure control gets worse||
2587|045|H|(such as the number of seizures increases).||
2587|046|B|||
2587|047|S|SIDE EFFECTS:  Dizziness, drowsiness, blurred/double vision,||
2587|048|S|nausea, vomiting, tiredness, unsteadiness, or shakiness (tremor)||
2587|049|S|may occur as your body adjusts to the medication. If any of these||
2587|050|S|effects last or get worse, tell your doctor or pharmacist||
2587|051|S|promptly.||
2587|052|S|   Remember that this medication has been prescribed because your||
2587|053|S|doctor has judged that the benefit to you is greater than the||
2587|054|S|risk of side effects. Many people using this medication do not||
2587|055|S|have serious side effects.||
2587|056|S|   A small number of people who take anticonvulsants for any||
2587|057|S|condition (such as seizure, bipolar disorder, pain) may||
2587|058|S|experience depression, suicidal thoughts/attempts, or other||
2587|059|S|mental/mood problems. Tell your doctor right away if you or your||
2587|060|S|family/caregiver notice any unusual/sudden changes in your mood,||
2587|061|S|thoughts, or behavior such as signs of depression, suicidal||
2587|062|S|thoughts/attempts, thoughts about harming yourself.||
2587|063|S|   Get medical help right away if you have any very serious side||
2587|064|S|effects, including: fast/slow/irregular/pounding heartbeat, chest||
2587|065|S|pain, severe dizziness, fainting.||
2587|066|S|   A very serious allergic reaction to this drug is rare.||
2587|067|S|However, get medical help right away if you notice any symptoms||
2587|068|S|of a serious allergic reaction, including: fever, swollen lymph||
2587|069|S|nodes, rash, itching/swelling (especially of the||
2587|070|S|face/tongue/throat), severe dizziness, trouble breathing.||
2587|071|S|   This is not a complete list of possible side effects. If you||
2587|072|S|notice other effects not listed above, contact your doctor or||
2587|073|S|pharmacist.||
2587|074|S|   In the US -||
2587|075|S|   Call your doctor for medical advice about side effects. You||
2587|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2587|077|S|www.fda.gov/medwatch.||
2587|078|S|   In Canada - Call your doctor for medical advice about side||
2587|079|S|effects. You may report side effects to Health Canada at||
2587|080|S|1-866-234-2345.||
2587|081|B|||
2587|082|P|PRECAUTIONS:  Before taking lacosamide, tell your doctor or||
2587|083|P|pharmacist if you are allergic to it; or if you have any other||
2587|084|P|allergies. This product may contain inactive ingredients, which||
2587|085|P|can cause allergic reactions or other problems. Talk to your||
2587|086|P|pharmacist for more details.||
2587|087|P|   Before using this medication, tell your doctor or pharmacist||
2587|088|P|your medical history, especially of: heart problems (such as||
2587|089|P|chest pain, sick sinus syndrome, heart failure, AV block,||
2587|090|P|irregular heartbeat), liver problems, kidney problems (including||
2587|091|P|dialysis treatment), mental/mood problems (such as depression,||
2587|092|P|psychosis), personal or family history of a substance use||
2587|093|P|disorder (such as overuse of or addiction to drugs/alcohol).||
2587|094|P|   This drug may make you dizzy or drowsy or cause blurred||
2587|095|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
2587|096|P|or drowsy. Do not drive, use machinery, or do anything that needs||
2587|097|P|alertness or clear vision until you can do it safely. Avoid||
2587|098|P|alcoholic beverages. Talk to your doctor if you are using||
2587|099|P|marijuana (cannabis).||
2587|100|P|   Before having surgery, tell your doctors or dentist about all||
2587|101|P|the products you use (including prescription drugs,||
2587|102|P|nonprescription drugs, and herbal products).||
2587|103|P|   During pregnancy, this medication should be used only when||
2587|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
2587|105|P|   This drug passes into breast milk and may have undesirable||
2587|106|P|effects on a nursing infant. Consult your doctor before||
2587|107|P|breastfeeding.||
2587|108|B|||
2587|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2587|110|I|medications work or increase your risk for serious side effects.||
2587|111|I|This document does not contain all possible drug interactions.||
2587|112|I|Keep a list of all the products you use (including||
2587|113|I|prescription/nonprescription drugs and herbal products) and share||
2587|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
2587|115|I|the dosage of any medicines without your doctor's approval.||
2587|116|I|   A product that may interact with this drug is: orlistat.||
2587|117|I|   Tell your doctor or pharmacist if you are using other products||
2587|118|I|that cause drowsiness such as opioid pain or cough relievers||
2587|119|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2587|120|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2587|121|I|zolpidem), muscle relaxants (such as carisoprodol,||
2587|122|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2587|123|I|diphenhydramine).||
2587|124|I|   Check the labels on all your medicines (such as allergy or||
2587|125|I|cough-and-cold products) because they may contain ingredients||
2587|126|I|that cause drowsiness. Ask your pharmacist about using those||
2587|127|I|products safely.||
2587|128|B|||
2587|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2587|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2587|131|O|poison control center right away. US residents can call||
2587|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2587|133|O|Symptoms of overdose may include: severe nausea/vomiting,||
2587|134|O|difficulty waking up, confusion, irregular heartbeat, very slow||
2587|135|O|breathing.||
2587|136|B|||
2587|137|N|NOTES:  Do not share this medication with others. Sharing it is||
2587|138|N|against the law.||
2587|139|N|   Lab and/or medical tests (such as liver/kidney function, EKG)||
2587|140|N|may be done while you are taking this medication. Keep all||
2587|141|N|medical and lab appointments. Consult your doctor for more||
2587|142|N|details.||
2587|143|B|||
2587|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2587|145|D|remember. If it is near the time of the next dose, skip the||
2587|146|D|missed dose. Take your next dose at the regular time. Do not||
2587|147|D|double the dose to catch up.||
2587|148|B|||
2587|149|R|STORAGE:  Store at room temperature away from light and moisture.||
2587|150|R|Do not store in the bathroom. Keep all medications away from||
2587|151|R|children and pets.||
2587|152|R|   Do not flush medications down the toilet or pour them into a||
2587|153|R|drain unless instructed to do so. Properly discard this product||
2587|154|R|when it is expired or no longer needed. Consult your pharmacist||
2587|155|R|or local waste disposal company.||
2587|156|B|||
2587|157|M|MEDICAL ALERT:  Your condition can cause complications in a||
2587|158|M|medical emergency. For information about enrolling in MedicAlert,||
2587|159|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2587|160|B|||
2587|161|A|Information last revised November 2024.||
2587|162|A|Copyright(c) 2025 First Databank, Inc.||
2587|163|B|||
2588|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2588|002|Z|does NOT have all possible information about this product. This||
2588|003|Z|information does not assure that this product is safe, effective,||
2588|004|Z|or appropriate for you. This information is not individual||
2588|005|Z|medical advice and does not substitute for the advice of your||
2588|006|Z|health care professional. Always ask your health care||
2588|007|Z|professional for complete information about this product and your||
2588|008|Z|specific health needs.||
2588|009|B|||
2588|010|T|UPADACITINIB SOLUTION - ORAL||
2588|011|F|(ue-PAD-a-SYE-ti-nib)||
2588|012|B|||
2588|013|C|COMMON BRAND NAME(S): Rinvoq LQ||
2588|014|B|||
2588|015|W|WARNING:  Upadacitinib may lower your ability to fight||
2588|016|W|infections. This may make you more likely to get a serious||
2588|017|W|(rarely fatal) infection or make any infection you have worse.||
2588|018|W|The most common serious infections include pneumonia and skin||
2588|019|W|infections. The risk for infections may be higher if you also||
2588|020|W|take other drugs that suppress the immune system (such as||
2588|021|W|methotrexate, corticosteroids). Tell your doctor right away if||
2588|022|W|you have any signs of infection (such as a sore throat that||
2588|023|W|doesn't go away, fever, chills, cough, non-healing skin sores,||
2588|024|W|painful/frequent urination, white patches in your mouth or on||
2588|025|W|your tongue).||
2588|026|W|   You should have a tuberculosis (TB) skin test before and||
2588|027|W|during treatment with this medication. Tell your doctor if you||
2588|028|W|have been near someone with tuberculosis or have lived or||
2588|029|W|traveled in areas where certain fungal infections (such as||
2588|030|W|coccidioidomycosis, histoplasmosis) are common. These areas||
2588|031|W|include the Ohio and Mississippi River valleys and the||
2588|032|W|southwestern United States.||
2588|033|W|   Though it is very unlikely to occur, there may be a risk of||
2588|034|W|developing cancer (such as lymphoma, skin cancer, lung cancer)||
2588|035|W|with this medication. Your risk may be higher if you are a||
2588|036|W|current or past smoker. Protect your skin from the sun. Avoid||
2588|037|W|prolonged sun exposure, tanning booths, and sunlamps. Use a||
2588|038|W|sunscreen and wear protective clothing when outdoors. Tell your||
2588|039|W|doctor right away if you develop symptoms such as fever or cough||
2588|040|W|that doesn't go away, wheezing, unusual lumps/growths,||
2588|041|W|unexplained weight loss, night sweats, change in appearance or||
2588|042|W|size of moles, or unusual skin changes.||
2588|043|W|   Upadacitinib may rarely cause serious (sometimes fatal)||
2588|044|W|problems from blood clots (such as heart attack, stroke, blood||
2588|045|W|clots in the lungs or legs). You may be at an increased risk for||
2588|046|W|blood clots if you are a current or past smoker, or are 50 years||
2588|047|W|of age or older and have at least one risk factor for heart||
2588|048|W|disease. Discuss the risks and benefits of treatment with your||
2588|049|W|doctor. Get medical help right away if you develop symptoms of||
2588|050|W|blood clots, such as shortness of breath/rapid breathing,||
2588|051|W|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
2588|052|W|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
2588|053|W|sudden/severe headaches, trouble speaking, weakness on one side||
2588|054|W|of the body, or sudden vision changes.||
2588|055|B|||
2588|056|U|USES:  Upadacitinib is used to treat certain types of arthritis||
2588|057|U|(such as psoriatic arthritis, polyarticular juvenile idiopathic||
2588|058|U|arthritis- pJIA). It helps decrease pain, tenderness, and||
2588|059|U|swelling in the joints.||
2588|060|B|||
2588|061|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2588|062|H|Instructions for Use provided by your pharmacist before you start||
2588|063|H|taking upadacitinib and each time you get a refill. If you have||
2588|064|H|any questions, ask your doctor or pharmacist.||
2588|065|H|   Take this medication by mouth with or without food as directed||
2588|066|H|by your doctor, usually twice daily. Carefully measure the dose||
2588|067|H|using the oral syringe that comes with this medication. Do not||
2588|068|H|use a household spoon because you may not get the correct dose.||
2588|069|H|After each dose, drink some water to make sure all the dose is||
2588|070|H|taken. Do not keep the medication in the oral syringe for more||
2588|071|H|than 1 hour. Rinse the syringe with water after each use. If you||
2588|072|H|have any questions, consult your doctor or pharmacist.||
2588|073|H|   Use this medication regularly to get the most benefit from it.||
2588|074|H|To help you remember, take it at the same times each day.||
2588|075|H|   The dosage is based on your medical condition, response to||
2588|076|H|treatment, age, weight, and other medications you may be taking.||
2588|077|H|Be sure to tell your doctor and pharmacist about all the products||
2588|078|H|you use (including prescription drugs, nonprescription drugs, and||
2588|079|H|herbal products).||
2588|080|H|   Do not increase your dose or use this drug more often or for||
2588|081|H|longer than prescribed. Your condition will not improve any||
2588|082|H|faster, and your risk of side effects will increase.||
2588|083|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2588|084|H|using this medication unless your doctor or pharmacist says you||
2588|085|H|may do so safely. Grapefruit can increase the chance of side||
2588|086|H|effects with this medicine. Ask your doctor or pharmacist for||
2588|087|H|more details.||
2588|088|H|   Tell your doctor if your condition does not get better or if||
2588|089|H|it gets worse.||
2588|090|B|||
2588|091|S|SIDE EFFECTS:  See also Warning section.||
2588|092|S|   Nausea or headache may occur. If either of these effects lasts||
2588|093|S|or gets worse, tell your doctor or pharmacist promptly.||
2588|094|S|   People using this medication may have serious side effects.||
2588|095|S|However, you have been prescribed this drug because your doctor||
2588|096|S|has judged that the benefit to you is greater than the risk of||
2588|097|S|side effects. Careful monitoring by your doctor may decrease your||
2588|098|S|risk.||
2588|099|S|   Tell your doctor right away if you have any serious side||
2588|100|S|effects, including: signs of anemia (such as unusual tiredness,||
2588|101|S|pale skin, fast heartbeat), signs of liver disease (such as||
2588|102|S|nausea/vomiting that doesn't stop, loss of appetite,||
2588|103|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2588|104|S|of a serious tear in the stomach or intestinal wall (such as||
2588|105|S|severe stomach/abdominal pain that doesn't go away, fever, severe||
2588|106|S|dizziness, fainting, severe nausea/vomiting).||
2588|107|S|   Get medical help right away if you have any very serious side||
2588|108|S|effects, including: sudden vision changes (such as blurred||
2588|109|S|vision, seeing flashes of light).||
2588|110|S|   A very serious allergic reaction to this drug is rare.||
2588|111|S|However, get medical help right away if you notice any symptoms||
2588|112|S|of a serious allergic reaction, including: rash, itching/swelling||
2588|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2588|114|S|breathing.||
2588|115|S|   This is not a complete list of possible side effects. If you||
2588|116|S|notice other effects not listed above, contact your doctor or||
2588|117|S|pharmacist.||
2588|118|S|   In the US -||
2588|119|S|   Call your doctor for medical advice about side effects. You||
2588|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2588|121|S|www.fda.gov/medwatch.||
2588|122|S|   In Canada - Call your doctor for medical advice about side||
2588|123|S|effects. You may report side effects to Health Canada at||
2588|124|S|1-866-234-2345.||
2588|125|B|||
2588|126|P|PRECAUTIONS:  See also Warning section.||
2588|127|P|   Before taking upadacitinib, tell your doctor or pharmacist if||
2588|128|P|you are allergic to it; or if you have any other allergies. This||
2588|129|P|product may contain inactive ingredients, which can cause||
2588|130|P|allergic reactions or other problems. Talk to your pharmacist for||
2588|131|P|more details.||
2588|132|P|   Before using this medication, tell your doctor or pharmacist||
2588|133|P|your medical history, especially of: blood clots (such as in the||
2588|134|P|lungs, legs), blood/bone marrow problems (such as anemia),||
2588|135|P|cancer, heart problems (such as previous heart attack), liver||
2588|136|P|disease (such as hepatitis B or C), past/recent/current||
2588|137|P|infections (such as tuberculosis, herpes zoster, HIV infection),||
2588|138|P|current or past smoking, stomach/intestinal problems (such as||
2588|139|P|ulcers, diverticulitis), stroke, kidney disease.||
2588|140|P|   Upadacitinib can make you more likely to get infections or may||
2588|141|P|make current infections worse. Stay away from anyone who has an||
2588|142|P|infection that may easily spread (such as chickenpox, COVID-19,||
2588|143|P|measles, flu). Talk to your doctor if you have been exposed to an||
2588|144|P|infection or for more details.||
2588|145|P|   Tell your health care professional that you are using||
2588|146|P|upadacitinib before having any immunizations/vaccinations. Avoid||
2588|147|P|contact with people who have recently received live vaccines||
2588|148|P|(such as flu vaccine inhaled through the nose).||
2588|149|P|   Before having surgery, tell your doctor or dentist about all||
2588|150|P|the products you use (including prescription drugs,||
2588|151|P|nonprescription drugs, and herbal products).||
2588|152|P|   Older adults may be at greater risk for side effects while||
2588|153|P|using this drug.||
2588|154|P|   Tell your doctor if you are pregnant or plan to become||
2588|155|P|pregnant. You should not become pregnant while using||
2588|156|P|upadacitinib. Upadacitinib may harm an unborn baby. Your doctor||
2588|157|P|should order a pregnancy test before you start this medication.||
2588|158|P|Ask about reliable forms of birth control while using this||
2588|159|P|medication and for 4 weeks after the last dose. If you become||
2588|160|P|pregnant, talk to your doctor right away about the risks and||
2588|161|P|benefits of this medication.||
2588|162|P|   It is unknown if this medication passes into breast milk.||
2588|163|P|Because of the possible risk to the infant, breastfeeding is not||
2588|164|P|recommended while using this medication and for 6 days after the||
2588|165|P|last dose. Consult your doctor before breastfeeding.||
2588|166|B|||
2588|167|I|DRUG INTERACTIONS:  See also How to Use section.||
2588|168|I|   Drug interactions may change how your medications work or||
2588|169|I|increase your risk for serious side effects. This document does||
2588|170|I|not contain all possible drug interactions. Keep a list of all||
2588|171|I|the products you use (including prescription/nonprescription||
2588|172|I|drugs and herbal products) and share it with your doctor and||
2588|173|I|pharmacist. Do not start, stop, or change the dosage of any||
2588|174|I|medicines without your doctor's approval.||
2588|175|I|   Other medications can affect the removal of upadacitinib from||
2588|176|I|your body, which may affect how upadacitinib works. Examples||
2588|177|I|include rifampin, phenytoin, among others.||
2588|178|B|||
2588|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2588|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2588|181|O|poison control center right away. US residents can call||
2588|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2588|183|B|||
2588|184|N|NOTES:  Do not share this medication with others.||
2588|185|N|   Lab and/or medical tests (such as liver function, complete||
2588|186|N|blood count, cholesterol levels, skin exams) should be done while||
2588|187|N|you are taking this medication. Keep all medical and lab||
2588|188|N|appointments.||
2588|189|B|||
2588|190|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2588|191|D|remember. If it is near the time of the next dose, skip the||
2588|192|D|missed dose. Take your next dose at the regular time. Do not||
2588|193|D|double the dose to catch up.||
2588|194|B|||
2588|195|R|STORAGE:  Store in the refrigerator or at room temperature. Keep||
2588|196|R|the bottle tightly closed and in an upright position. Once the||
2588|197|R|bottle is opened, this medication expires after 60 days. Keep all||
2588|198|R|medications away from children and pets.||
2588|199|R|   Do not flush medications down the toilet or pour them into a||
2588|200|R|drain unless instructed to do so. Properly discard this product||
2588|201|R|when it is expired or no longer needed. Consult your pharmacist||
2588|202|R|or local waste disposal company.||
2588|203|B|||
2588|204|M|MEDICAL ALERT:  Your condition can cause complications in a||
2588|205|M|medical emergency. For information about enrolling in MedicAlert,||
2588|206|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2588|207|B|||
2588|208|A|Information last revised September 2024.||
2588|209|A|Copyright(c) 2025 First Databank, Inc.||
2588|210|B|||
2589|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2589|002|Z|does NOT have all possible information about this product. This||
2589|003|Z|information does not assure that this product is safe, effective,||
2589|004|Z|or appropriate for you. This information is not individual||
2589|005|Z|medical advice and does not substitute for the advice of your||
2589|006|Z|health care professional. Always ask your health care||
2589|007|Z|professional for complete information about this product and your||
2589|008|Z|specific health needs.||
2589|009|B|||
2589|010|T|DEFLAZACORT - ORAL||
2589|011|F|(dee-FLAYZ-a-kort)||
2589|012|B|||
2589|013|C|COMMON BRAND NAME(S): Emflaza||
2589|014|B|||
2589|015|U|USES:  This medication is used to treat a certain inherited||
2589|016|U|muscle disorder (Duchenne muscular dystrophy-DMD). Deflazacort||
2589|017|U|belongs to a class of drugs known as corticosteroids.||
2589|018|B|||
2589|019|H|HOW TO USE:  Read the Instructions for Use if available from your||
2589|020|H|pharmacist before you start taking deflazacort and each time you||
2589|021|H|get a refill. If you have any questions, ask your doctor or||
2589|022|H|pharmacist.||
2589|023|H|   Take this medication by mouth with or without food as directed||
2589|024|H|by your doctor, usually once daily.||
2589|025|H|   If you are using the tablet form of this medication, the||
2589|026|H|tablets may be swallowed whole or crushed and mixed in||
2589|027|H|applesauce. After mixing the medication in applesauce, take all||
2589|028|H|of the mixture right away. Do not prepare a supply for future||
2589|029|H|use.||
2589|030|H|   If you are using the liquid form of this medication, shake the||
2589|031|H|bottle well before each dose. Carefully measure the dose using a||
2589|032|H|special measuring device/spoon. Do not use a household spoon||
2589|033|H|because you may not get the correct dose. Mix the measured dose||
2589|034|H|with half a glass (3 to 4 ounces/90 to 120 milliliters) of juice||
2589|035|H|or milk. Do not use grapefruit juice. Take all of the mixture||
2589|036|H|right away. Do not prepare a supply in advance. Consult your||
2589|037|H|pharmacist if you have any questions.||
2589|038|H|   The dosage is based on your medical condition, response to||
2589|039|H|treatment, weight, and other medications you may be taking. Be||
2589|040|H|sure to tell your doctor and pharmacist about all the products||
2589|041|H|you use (including prescription drugs, nonprescription drugs, and||
2589|042|H|herbal products).||
2589|043|H|   Use this medication regularly to get the most benefit from it.||
2589|044|H|To help you remember, take it at the same time each day.||
2589|045|H|   Do not increase your dose or use this drug more often or for||
2589|046|H|longer than prescribed. Your condition will not improve any||
2589|047|H|faster, and your risk of side effects will increase.||
2589|048|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2589|049|H|using this medication unless your doctor or pharmacist says you||
2589|050|H|may do so safely. Grapefruit can increase the chance of side||
2589|051|H|effects with this medicine. Ask your doctor or pharmacist for||
2589|052|H|more details.||
2589|053|H|   Do not stop taking this medication without consulting your||
2589|054|H|doctor. Some conditions may become worse when this drug is||
2589|055|H|suddenly stopped. Also, you may experience symptoms such as||
2589|056|H|weakness, weight loss, nausea, vomiting, muscle pain, headache,||
2589|057|H|and tiredness. To prevent these symptoms while you are stopping||
2589|058|H|treatment with this drug, your doctor may reduce your dose||
2589|059|H|gradually. Consult your doctor or pharmacist for more details.||
2589|060|H|Report any new or worsening symptoms right away.||
2589|061|B|||
2589|062|S|SIDE EFFECTS:  Abnormal growth of body hair, increased appetite,||
2589|063|S|or weight gain may occur. If any of these effects last or get||
2589|064|S|worse, tell your doctor or pharmacist promptly.||
2589|065|S|   Remember that this medication has been prescribed because your||
2589|066|S|doctor has judged that the benefit to you is greater than the||
2589|067|S|risk of side effects. Many people using this medication do not||
2589|068|S|have serious side effects.||
2589|069|S|   Tell your doctor right away if you have any serious side||
2589|070|S|effects, including: weakness, puffy face, unusual weight gain,||
2589|071|S|swelling ankles/feet/hands, slow wound healing, thinning skin,||
2589|072|S|bone pain, menstrual period changes, mental/mood changes (such as||
2589|073|S|depression, mood swings, agitation), easy bruising/bleeding,||
2589|074|S|symptoms of stomach/intestinal bleeding (such as||
2589|075|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
2589|076|S|coffee grounds), vision problems, red/purple spots on the skin.||
2589|077|S|   This medication may rarely make your blood sugar rise, which||
2589|078|S|can cause or worsen diabetes. Tell your doctor right away if you||
2589|079|S|have symptoms of high blood sugar such as increased||
2589|080|S|thirst/urination. If you already have diabetes, check your blood||
2589|081|S|sugar regularly as directed and share the results with your||
2589|082|S|doctor. Your doctor may need to adjust your diabetes medication,||
2589|083|S|exercise program, or diet.||
2589|084|S|   This medication may lower your ability to fight infections.||
2589|085|S|This may make you more likely to get a serious (rarely fatal)||
2589|086|S|infection or make any infection you have worse. Tell your doctor||
2589|087|S|right away if you have any signs of infection (such as sore||
2589|088|S|throat that doesn't go away, fever, chills).||
2589|089|S|   Deflazacort can commonly cause a rash that is usually not||
2589|090|S|serious. However, you may not be able to tell it apart from a||
2589|091|S|rare rash that could be a sign of a severe reaction. Get medical||
2589|092|S|help right away if you develop any rash.||
2589|093|S|   A very serious allergic reaction to this drug is rare.||
2589|094|S|However, get medical help right away if you notice any symptoms||
2589|095|S|of a serious allergic reaction, including: rash, itching/swelling||
2589|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2589|097|S|breathing.||
2589|098|S|   This is not a complete list of possible side effects. If you||
2589|099|S|notice other effects not listed above, contact your doctor or||
2589|100|S|pharmacist.||
2589|101|S|   In the US -||
2589|102|S|   Call your doctor for medical advice about side effects. You||
2589|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2589|104|S|www.fda.gov/medwatch.||
2589|105|S|   In Canada - Call your doctor for medical advice about side||
2589|106|S|effects. You may report side effects to Health Canada at||
2589|107|S|1-866-234-2345.||
2589|108|B|||
2589|109|P|PRECAUTIONS:  Before taking deflazacort, tell your doctor or||
2589|110|P|pharmacist if you are allergic to it; or if you have any other||
2589|111|P|allergies. This product may contain inactive ingredients, which||
2589|112|P|can cause allergic reactions or other problems. Talk to your||
2589|113|P|pharmacist for more details.||
2589|114|P|   Before using this medication, tell your doctor or pharmacist||
2589|115|P|your medical history, especially of: infections (such as||
2589|116|P|tuberculosis, herpes, fungal infections), high blood pressure,||
2589|117|P|heart problems (such as heart failure, recent heart attack),||
2589|118|P|kidney disease, liver disease (such as hepatitis B), mental/mood||
2589|119|P|disorders (such as psychosis, anxiety, depression), mineral||
2589|120|P|imbalance (such as low level of potassium/calcium in the blood),||
2589|121|P|thyroid disease, stomach/intestinal problems (such as ulcer,||
2589|122|P|ulcerative colitis, diverticulitis, unexplained diarrhea),||
2589|123|P|diabetes, eye problems (such as cataracts, glaucoma), bone loss||
2589|124|P|(osteoporosis), blood clots, a certain adrenal gland tumor||
2589|125|P|(pheochromocytoma).||
2589|126|P|   Using corticosteroid medications for a long time can make it||
2589|127|P|more difficult for your body to respond to physical stress.||
2589|128|P|Before having surgery or emergency treatment, or if you get a||
2589|129|P|serious illness/injury, tell your doctor or dentist that you are||
2589|130|P|using this medication or have used this medication within the||
2589|131|P|past 12 months. Tell your doctor right away if you develop||
2589|132|P|unusual/extreme tiredness or weight loss. If you will be using||
2589|133|P|this medication for a long time, carry a warning card or medical||
2589|134|P|ID bracelet that identifies your use of this medication.||
2589|135|P|   Deflazacort can make you more likely to get infections or may||
2589|136|P|make current infections worse. Stay away from anyone who has an||
2589|137|P|infection that may easily spread (such as chickenpox, COVID-19,||
2589|138|P|measles, flu). Talk to your doctor if you have been exposed to an||
2589|139|P|infection or for more details.||
2589|140|P|   Tell your health care professional that you are using||
2589|141|P|deflazacort before having any immunizations/vaccinations. Avoid||
2589|142|P|contact with people who have recently received live vaccines||
2589|143|P|(such as flu vaccine inhaled through the nose).||
2589|144|P|   This medication may cause stomach bleeding. Daily use of||
2589|145|P|alcohol while using this medication may increase your risk for||
2589|146|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
2589|147|P|or pharmacist for more information.||
2589|148|P|   Before having surgery, tell your doctor or dentist about all||
2589|149|P|the products you use (including prescription drugs,||
2589|150|P|nonprescription drugs, and herbal products).||
2589|151|P|   This medication may slow down a child's growth if used for a||
2589|152|P|long time. Consult the doctor or pharmacist for more details. See||
2589|153|P|the doctor regularly so your child's height and growth can be||
2589|154|P|checked.||
2589|155|P|   During pregnancy, this medication should be used only when||
2589|156|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
2589|157|P|risks and benefits with your doctor. Infants born to mothers who||
2589|158|P|have been using this medication for an extended time may have||
2589|159|P|hormone problems. Tell your doctor right away if you notice||
2589|160|P|symptoms such as nausea/vomiting that doesn't stop, severe||
2589|161|P|diarrhea, or weakness in your newborn.||
2589|162|P|   It is unknown if this medication passes into breast milk.||
2589|163|P|Consult your doctor before breastfeeding.||
2589|164|B|||
2589|165|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2589|166|I|medications work or increase your risk for serious side effects.||
2589|167|I|This document does not contain all possible drug interactions.||
2589|168|I|Keep a list of all the products you use (including||
2589|169|I|prescription/nonprescription drugs and herbal products) and share||
2589|170|I|it with your doctor and pharmacist. Do not start, stop, or change||
2589|171|I|the dosage of any medicines without your doctor's approval.||
2589|172|I|   Some products that may interact with this drug are:||
2589|173|I|desmopressin, mifepristone, drugs that can cause||
2589|174|I|bleeding/bruising (including antiplatelet drugs such as||
2589|175|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
2589|176|I|such as warfarin/dabigatran).||
2589|177|I|   If your doctor has told you to take low-dose aspirin to||
2589|178|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
2589|179|I|you should keep taking the aspirin unless your doctor tells you||
2589|180|I|not to. Ask your doctor or pharmacist for more details.||
2589|181|I|   This medication may interfere with certain lab tests (such as||
2589|182|I|skin tests), possibly causing false test results. Make sure lab||
2589|183|I|personnel and all your doctors know you use this drug.||
2589|184|B|||
2589|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2589|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2589|187|O|poison control center right away. US residents can call||
2589|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2589|189|B|||
2589|190|N|NOTES:  Do not share this medication with others.||
2589|191|N|   Lab and/or medical tests (such as blood mineral levels, blood||
2589|192|N|sugar, complete blood count, bone density, blood pressure, eye||
2589|193|N|exams) should be done while you are taking this medication. Keep||
2589|194|N|all medical and lab appointments.||
2589|195|N|   This medication may cause bone loss (osteoporosis) when used||
2589|196|N|for a long time. Lifestyle changes that may help reduce the risk||
2589|197|N|of bone problems include doing weight-bearing exercise, stopping||
2589|198|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2589|199|N|D. Talk to your doctor for more details.||
2589|200|B|||
2589|201|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2589|202|D|remember. If it is near the time of the next dose, skip the||
2589|203|D|missed dose. Take your next dose at the regular time. Do not||
2589|204|D|double the dose to catch up.||
2589|205|B|||
2589|206|R|STORAGE:  Store at room temperature away from light and moisture.||
2589|207|R|Do not store in the bathroom. If you are using the liquid form of||
2589|208|R|this medication, keep the bottle upright. Once the bottle for the||
2589|209|R|liquid form is opened, the medication expires after 1 month. Keep||
2589|210|R|all medications away from children and pets.||
2589|211|R|   Do not flush medications down the toilet or pour them into a||
2589|212|R|drain unless instructed to do so. Properly discard this product||
2589|213|R|when it is expired or no longer needed. Consult your pharmacist||
2589|214|R|or local waste disposal company.||
2589|215|B|||
2589|216|M|MEDICAL ALERT:  Your condition can cause complications in a||
2589|217|M|medical emergency. For information about enrolling in MedicAlert,||
2589|218|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2589|219|B|||
2589|220|A|Information last revised September 2025.||
2589|221|A|Copyright(c) 2025 First Databank, Inc.||
2589|222|B|||
2590|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2590|002|Z|does NOT have all possible information about this product. This||
2590|003|Z|information does not assure that this product is safe, effective,||
2590|004|Z|or appropriate for you. This information is not individual||
2590|005|Z|medical advice and does not substitute for the advice of your||
2590|006|Z|health care professional. Always ask your health care||
2590|007|Z|professional for complete information about this product and your||
2590|008|Z|specific health needs.||
2590|009|B|||
2590|010|T|GIVINOSTAT - ORAL||
2590|011|B|||
2590|012|C|COMMON BRAND NAME(S): Duvyzat||
2590|013|B|||
2590|014|U|USES:  This medication is used to treat a certain inherited||
2590|015|U|muscle disorder (Duchenne muscular dystrophy-DMD) that causes||
2590|016|U|muscles to weaken. Givinostat may help slow down the worsening of||
2590|017|U|muscle weakness.||
2590|018|B|||
2590|019|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2590|020|H|provided by your pharmacist before you start taking givinostat||
2590|021|H|and each time you get a refill. If you have any questions, ask||
2590|022|H|your doctor or pharmacist.||
2590|023|H|   Take this medication by mouth with food as directed by your||
2590|024|H|doctor, usually twice daily. The dosage is based on your weight||
2590|025|H|and response to treatment.||
2590|026|H|   Shake the bottle well for 30 seconds before each dose.||
2590|027|H|Carefully measure the dose using the oral syringe that comes with||
2590|028|H|the medication. Do not use a household spoon because you may not||
2590|029|H|get the correct dose. Swallow the medication right away. Do not||
2590|030|H|mix it with water or other liquids. Rinse the syringe with water||
2590|031|H|after each use. Consult your pharmacist if you have any||
2590|032|H|questions.||
2590|033|H|   Use this medication regularly to get the most benefit from it.||
2590|034|H|To help you remember, take it at the same times each day.||
2590|035|H|   Do not increase your dose or use this drug more often or for||
2590|036|H|longer than prescribed. Your condition will not improve any||
2590|037|H|faster, and your risk of side effects will increase.||
2590|038|B|||
2590|039|S|SIDE EFFECTS:  Diarrhea, abdominal pain, fever, nausea, or||
2590|040|S|vomiting may occur. Diarrhea, nausea, and vomiting can be severe.||
2590|041|S|In some cases, your doctor may prescribe medication to prevent or||
2590|042|S|relieve diarrhea, nausea, or vomiting. Eating several small||
2590|043|S|meals, not eating before treatment, or limiting activity may help||
2590|044|S|lessen some of these effects. If any of these effects last or get||
2590|045|S|worse, tell your doctor or pharmacist promptly.||
2590|046|S|   Remember that this medication has been prescribed because your||
2590|047|S|doctor has judged that the benefit to you is greater than the||
2590|048|S|risk of side effects. Many people using this medication do not||
2590|049|S|have serious side effects.||
2590|050|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2590|051|S|Contact your doctor promptly if you notice any symptoms of||
2590|052|S|dehydration, such as unusual decreased urination, unusual dry||
2590|053|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness.||
2590|054|S|   Tell your doctor right away if you have any serious side||
2590|055|S|effects, including: easy bruising/bleeding.||
2590|056|S|   Get medical help right away if you have any very serious side||
2590|057|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2590|058|S|fainting.||
2590|059|S|   A very serious allergic reaction to this drug is rare.||
2590|060|S|However, get medical help right away if you notice any symptoms||
2590|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2590|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2590|063|S|breathing.||
2590|064|S|   This is not a complete list of possible side effects. If you||
2590|065|S|notice other effects not listed above, contact your doctor or||
2590|066|S|pharmacist.||
2590|067|S|   In the US -||
2590|068|S|   Call your doctor for medical advice about side effects. You||
2590|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2590|070|S|www.fda.gov/medwatch.||
2590|071|S|   In Canada - Call your doctor for medical advice about side||
2590|072|S|effects. You may report side effects to Health Canada at||
2590|073|S|1-866-234-2345.||
2590|074|B|||
2590|075|P|PRECAUTIONS:  Before taking givinostat, tell your doctor or||
2590|076|P|pharmacist if you are allergic to it; or if you have any other||
2590|077|P|allergies. This product may contain inactive ingredients, which||
2590|078|P|can cause allergic reactions or other problems. Talk to your||
2590|079|P|pharmacist for more details.||
2590|080|P|   Before using this medication, tell your doctor or pharmacist||
2590|081|P|your medical history, especially of: bleeding problems.||
2590|082|P|   Givinostat may cause a condition that affects the heart rhythm||
2590|083|P|(QT prolongation). QT prolongation can rarely cause serious||
2590|084|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2590|085|P|as severe dizziness, fainting) that need medical attention right||
2590|086|P|away.||
2590|087|P|   The risk of QT prolongation may be increased if you have||
2590|088|P|certain medical conditions or are taking other drugs that may||
2590|089|P|cause QT prolongation. Before using givinostat, tell your doctor||
2590|090|P|or pharmacist of all the drugs you take and if you have any of||
2590|091|P|the following conditions: certain heart problems (heart failure,||
2590|092|P|slow heartbeat, QT prolongation in the EKG), family history of||
2590|093|P|certain heart problems (QT prolongation in the EKG, sudden||
2590|094|P|cardiac death).||
2590|095|P|   Low levels of potassium or magnesium in the blood may also||
2590|096|P|increase your risk of QT prolongation. This risk may increase if||
2590|097|P|you use certain drugs (such as diuretics/"water pills") or if you||
2590|098|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2590|099|P|Talk to your doctor about using givinostat safely.||
2590|100|P|   Before having surgery, tell your doctor or dentist about all||
2590|101|P|the products you use (including prescription drugs,||
2590|102|P|nonprescription drugs, and herbal products).||
2590|103|P|   Older adults may be more sensitive to the side effects of this||
2590|104|P|drug, especially QT prolongation (see above).||
2590|105|P|   During pregnancy, this medication should be used only when||
2590|106|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2590|107|P|benefits with your doctor.||
2590|108|P|   It is unknown if this medication passes into breast milk.||
2590|109|P|Consult your doctor before breastfeeding.||
2590|110|B|||
2590|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2590|112|I|medications work or increase your risk for serious side effects.||
2590|113|I|This document does not contain all possible drug interactions.||
2590|114|I|Keep a list of all the products you use (including||
2590|115|I|prescription/nonprescription drugs and herbal products) and share||
2590|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
2590|117|I|the dosage of any medicines without your doctor's approval.||
2590|118|I|   This medication can slow down the removal of other medications||
2590|119|I|from your body, which may affect how they work. An example of an||
2590|120|I|affected drug is dofetilide, among others.||
2590|121|B|||
2590|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2590|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2590|124|O|poison control center right away. US residents can call||
2590|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2590|126|B|||
2590|127|N|NOTES:  Do not share this medication with others.||
2590|128|N|   Lab and/or medical tests (such as complete blood count,||
2590|129|N|triglyceride level) should be done before you start taking this||
2590|130|N|medication and while you are taking it. Keep all medical and lab||
2590|131|N|appointments. Consult your doctor for more details.||
2590|132|B|||
2590|133|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2590|134|D|next dose at the regular time. Do not double the dose to catch||
2590|135|D|up.||
2590|136|B|||
2590|137|R|STORAGE:  Store the bottle upright at room temperature. Do not||
2590|138|R|freeze. Once the bottle is opened, this medication expires after||
2590|139|R|60 days. Keep all medications away from children and pets.||
2590|140|R|   Do not flush medications down the toilet or pour them into a||
2590|141|R|drain unless instructed to do so. Properly discard this product||
2590|142|R|when it is expired or no longer needed. Consult your pharmacist||
2590|143|R|or local waste disposal company.||
2590|144|B|||
2590|145|A|Information last revised September 2024.||
2590|146|A|Copyright(c) 2025 First Databank, Inc.||
2590|147|B|||
2591|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2591|002|Z|does NOT have all possible information about this product. This||
2591|003|Z|information does not assure that this product is safe, effective,||
2591|004|Z|or appropriate for you. This information is not individual||
2591|005|Z|medical advice and does not substitute for the advice of your||
2591|006|Z|health care professional. Always ask your health care||
2591|007|Z|professional for complete information about this product and your||
2591|008|Z|specific health needs.||
2591|009|B|||
2591|010|T|ALPELISIB (OVERGROWTH) - ORAL||
2591|011|F|(AL-pe-LIS-ib)||
2591|012|B|||
2591|013|C|COMMON BRAND NAME(S): Vijoice||
2591|014|B|||
2591|015|U|USES:  This medication is used to treat a certain overgrowth||
2591|016|U|disorder, PIK3CA-Related Overgrowth Spectrum (PROS). Alpelisib||
2591|017|U|belongs to a class of drugs known as kinase inhibitors. It works||
2591|018|U|by slowing or stopping the growth of certain abnormal cells that||
2591|019|U|can cause PROS.||
2591|020|B|||
2591|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2591|022|H|Instructions for Use if available from your pharmacist before you||
2591|023|H|start taking alpelisib and each time you get a refill. If you||
2591|024|H|have any questions, ask your doctor or pharmacist.||
2591|025|H|   Take this medication by mouth with food as directed by your||
2591|026|H|doctor, usually once daily. The dosage is based on your medical||
2591|027|H|condition, age, and response to treatment.||
2591|028|H|   If you are using the tablet form, swallow the tablets whole.||
2591|029|H|Do not chew, split, or crush the tablets. Do not take tablets||
2591|030|H|that are broken, cracked, or that look damaged. If you have||
2591|031|H|trouble swallowing these tablets, you may mix them with water to||
2591|032|H|make a suspension. Use only water to make the suspension. Place||
2591|033|H|the tablet(s) in a glass with 2 to 4 ounces (60 to 120||
2591|034|H|milliliters) of water and let it stand for about 5 minutes. Crush||
2591|035|H|the tablets with a spoon and stir well. The mixture will be||
2591|036|H|cloudy and you may see tablet pieces. Swallow the mixture right||
2591|037|H|away. To make sure you take all of the dose, add another 1 to 2||
2591|038|H|ounces (30 to 60 milliliters) of water to the glass. Stir well||
2591|039|H|and drink all of it. Repeat if any medicine remains in the glass.||
2591|040|H|Throw any mixture that is not taken within 60 minutes.||
2591|041|H|   If you are using the granules, use one single granule packet||
2591|042|H|to prepare your dose. Do not use partial packets or more than one||
2591|043|H|packet to prepare your dose. Do not combine tablets and granule||
2591|044|H|packets either. Shake the packet gently before opening. Open the||
2591|045|H|packet and pour the contents of it onto the tongue and swallow||
2591|046|H|with 2 to 4 ounces (60 to 120 milliliters) of water. You may||
2591|047|H|rinse your mouth with more water to make sure you took all of the||
2591|048|H|dose. You may also open the packet and pour the contents into a||
2591|049|H|cup with 1 to 3 teaspoonfuls (5 to 15 milliliters) of liquid||
2591|050|H|(water, milk, or apple juice) or soft food (applesauce or||
2591|051|H|yogurt). Swallow the mixture right away. To make sure you take||
2591|052|H|all of the dose, add another 2 ounces (60 milliliters) of liquid||
2591|053|H|(water, milk, or apple juice) to the cup. Mix and drink all of||
2591|054|H|it. Repeat if any medicine remains in the cup. Throw away any||
2591|055|H|mixture that is not taken within 60 minutes.||
2591|056|H|   If you are giving this medication through a feeding tube, ask||
2591|057|H|your health care professional for detailed instructions on how to||
2591|058|H|properly mix and give it.||
2591|059|H|   Use this medication regularly to get the most benefit from it.||
2591|060|H|To help you remember, take it at the same time each day.||
2591|061|H|   If you vomit after taking a dose, do not take another dose on||
2591|062|H|the same day. Wait until the next day to take your dose at the||
2591|063|H|regular time.||
2591|064|H|   Do not increase your dose or use this drug more often or for||
2591|065|H|longer than prescribed. Your condition will not improve any||
2591|066|H|faster, and your risk of side effects will increase.||
2591|067|H|   Since this drug can be absorbed through the skin and lungs and||
2591|068|H|may harm an unborn baby, women who are pregnant or who may become||
2591|069|H|pregnant should not handle this medication or breathe the dust||
2591|070|H|from the tablets.||
2591|071|B|||
2591|072|S|SIDE EFFECTS:  Nausea, vomiting, tiredness, change in how food||
2591|073|S|tastes, loss of appetite, decreased weight, or dry skin may||
2591|074|S|occur. If any of these effects last or get worse, tell your||
2591|075|S|doctor or pharmacist promptly.||
2591|076|S|   Diarrhea commonly occurs. Severe diarrhea can lead to||
2591|077|S|dehydration and kidney problems. If you have diarrhea, tell your||
2591|078|S|doctor right away. Drink enough fluids to prevent dehydration and||
2591|079|S|ask your doctor or pharmacist about medicines to treat diarrhea.||
2591|080|S|   Pain or sores in the mouth and throat may occur. Brush your||
2591|081|S|teeth carefully/gently, avoid using mouthwash that contains||
2591|082|S|alcohol, and rinse your mouth often with cool water mixed with||
2591|083|S|baking soda or salt. It may also be best to eat soft, moist||
2591|084|S|foods.||
2591|085|S|   Temporary hair loss may occur. Normal hair growth should||
2591|086|S|return after treatment has ended.||
2591|087|S|   People using this medication may have serious side effects.||
2591|088|S|However, you have been prescribed this drug because your doctor||
2591|089|S|has judged that the benefit to you is greater than the risk of||
2591|090|S|side effects. Careful monitoring by your doctor may decrease your||
2591|091|S|risk.||
2591|092|S|   Tell your doctor right away if you have any serious side||
2591|093|S|effects, including: symptoms of lung problems (such as shortness||
2591|094|S|of breath, cough, chest pain), abdominal pain, blood/mucus in||
2591|095|S|stool.||
2591|096|S|   This medication may make your blood sugar rise, which can||
2591|097|S|cause or worsen diabetes. Tell your doctor right away if you have||
2591|098|S|symptoms of high blood sugar, such as increased thirst/urination.||
2591|099|S|If you already have diabetes, check your blood sugar regularly as||
2591|100|S|directed and share the results with your doctor. Your doctor may||
2591|101|S|need to adjust your diabetes medication, exercise program, or||
2591|102|S|diet.||
2591|103|S|   A very serious allergic reaction to this drug is rare.||
2591|104|S|However, get medical help right away if you notice any symptoms||
2591|105|S|of a serious allergic reaction, including: fever, swollen lymph||
2591|106|S|nodes, rash, itching/swelling (especially of the||
2591|107|S|face/tongue/throat), severe dizziness, trouble breathing.||
2591|108|S|   This is not a complete list of possible side effects. If you||
2591|109|S|notice any other effects not listed above, contact your doctor or||
2591|110|S|pharmacist.||
2591|111|S|   In the US -||
2591|112|S|   Call your doctor for medical advice about side effects. You||
2591|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2591|114|S|www.fda.gov/medwatch.||
2591|115|S|   In Canada - Call your doctor for medical advice about side||
2591|116|S|effects. You may report side effects to Health Canada at||
2591|117|S|1-866-234-2345.||
2591|118|B|||
2591|119|P|PRECAUTIONS:  Before taking alpelisib, tell your doctor or||
2591|120|P|pharmacist if you are allergic to it; or if you have any other||
2591|121|P|allergies. This product may contain inactive ingredients, which||
2591|122|P|can cause allergic reactions or other problems. Talk to your||
2591|123|P|pharmacist for more details.||
2591|124|P|   Before using this medication, tell your doctor or pharmacist||
2591|125|P|your medical history, especially of: diabetes, liver disease,||
2591|126|P|history of severe skin reactions (such as Stevens-Johnson||
2591|127|P|syndrome, erythema multiforme, toxic epidermal necrolysis).||
2591|128|P|   Before having surgery, tell your doctor or dentist about all||
2591|129|P|the products you use (including prescription drugs,||
2591|130|P|nonprescription drugs, and herbal products).||
2591|131|P|   Older adults may be more sensitive to the side effects of this||
2591|132|P|drug, especially increased blood sugar.||
2591|133|P|   Since this drug can be absorbed through the skin and lungs and||
2591|134|P|may harm an unborn baby, women who are pregnant or who may become||
2591|135|P|pregnant should not handle this medication or breathe the dust||
2591|136|P|from the tablets.||
2591|137|P|   Tell your doctor if you are pregnant or plan to become||
2591|138|P|pregnant. You should not become pregnant while using alpelisib.||
2591|139|P|Alpelisib may harm an unborn baby. Your doctor should order a||
2591|140|P|pregnancy test before you start this medication. Men and women||
2591|141|P|using this medication should ask about reliable forms of birth||
2591|142|P|control during treatment and for 1 week after the last dose. If||
2591|143|P|you or your partner becomes pregnant, talk to your doctor right||
2591|144|P|away about the risks and benefits of this medication.||
2591|145|P|   It is unknown if this medication passes into breast milk.||
2591|146|P|Because of the possible risk to the infant, breastfeeding is not||
2591|147|P|recommended while using this medication and for 1 week after the||
2591|148|P|last dose. Consult your doctor before breastfeeding.||
2591|149|B|||
2591|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2591|151|I|medications work or increase your risk for serious side effects.||
2591|152|I|This document does not contain all possible drug interactions.||
2591|153|I|Keep a list of all the products you use (including||
2591|154|I|prescription/nonprescription drugs and herbal products) and share||
2591|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
2591|156|I|the dosage of any medicines without your doctor's approval.||
2591|157|I|   Other medications can affect the removal of alpelisib from||
2591|158|I|your body, which may affect how alpelisib works. Examples include||
2591|159|I|apalutamide, rifamycins (such as rifampin), St. John's wort,||
2591|160|I|drugs used to treat seizures (such as carbamazepine, phenytoin),||
2591|161|I|among others.||
2591|162|B|||
2591|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2591|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2591|165|O|poison control center right away. US residents can call||
2591|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2591|167|B|||
2591|168|N|NOTES:  Do not share this medication with others.||
2591|169|N|   Lab and/or medical tests (such as complete blood count, blood||
2591|170|N|sugar, kidney/liver function) should be done while you are taking||
2591|171|N|this medication. Keep all medical and lab appointments.||
2591|172|B|||
2591|173|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2591|174|D|remember. If it is more than 9 hours after the missed dose, skip||
2591|175|D|the missed dose. Take your next dose at the regular time. Do not||
2591|176|D|double the dose to catch up.||
2591|177|B|||
2591|178|R|STORAGE:  Store in the original container at room temperature||
2591|179|R|away from light and moisture. Do not store in the bathroom. Keep||
2591|180|R|all medications away from children and pets.||
2591|181|R|   Do not flush medications down the toilet or pour them into a||
2591|182|R|drain unless instructed to do so. Properly discard this product||
2591|183|R|when it is expired or no longer needed. Consult your pharmacist||
2591|184|R|or local waste disposal company.||
2591|185|B|||
2591|186|A|Information last revised July 2025.||
2591|187|A|Copyright(c) 2025 First Databank, Inc.||
2591|188|B|||
2592|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2592|002|Z|does NOT have all possible information about this product. This||
2592|003|Z|information does not assure that this product is safe, effective,||
2592|004|Z|or appropriate for you. This information is not individual||
2592|005|Z|medical advice and does not substitute for the advice of your||
2592|006|Z|health care professional. Always ask your health care||
2592|007|Z|professional for complete information about this product and your||
2592|008|Z|specific health needs.||
2592|009|B|||
2592|010|T|ELAFIBRANOR - ORAL||
2592|011|F|(EL-a-FIB-ra-nor)||
2592|012|B|||
2592|013|C|COMMON BRAND NAME(S): Iqirvo||
2592|014|B|||
2592|015|U|USES:  Elafibranor is used treat a certain type of liver disease||
2592|016|U|(primary biliary cholangitis - PBC). PBC causes too much bile to||
2592|017|U|stay in the liver, which can damage the liver. Elafibranor may||
2592|018|U|work by decreasing the amount of bile that your liver makes.||
2592|019|B|||
2592|020|H|HOW TO USE:  Read the Medication Guide provided by your||
2592|021|H|pharmacist before you start taking elafibranor and each time you||
2592|022|H|get a refill. If you have any questions, ask your doctor or||
2592|023|H|pharmacist.||
2592|024|H|   Take this medication by mouth with or without food as directed||
2592|025|H|by your doctor, usually once daily.||
2592|026|H|   If you also take certain drugs to lower your cholesterol (bile||
2592|027|H|acid-binding resins such as cholestyramine or colestipol), take||
2592|028|H|elafibranor at least 4 hours before or at least 4 hours after||
2592|029|H|taking these medications. These products can react with||
2592|030|H|elafibranor, preventing its full absorption.||
2592|031|H|   Do not increase your dose or take this medication more often||
2592|032|H|or for longer than prescribed. Your condition will not improve||
2592|033|H|any faster, and your risk of side effects will increase.||
2592|034|H|   Take this medication regularly to get the most benefit from||
2592|035|H|it. To help you remember, take it at the same time each day.||
2592|036|H|   Tell your doctor if your condition gets worse.||
2592|037|B|||
2592|038|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, constipation,||
2592|039|S|heartburn, dry mouth, joint pain, or weight changes may occur. If||
2592|040|S|any of these effects last or get worse, tell your doctor or||
2592|041|S|pharmacist promptly.||
2592|042|S|   Remember that this medication has been prescribed because your||
2592|043|S|doctor has judged that the benefit to you is greater than the||
2592|044|S|risk of side effects. Many people using this medication do not||
2592|045|S|have serious side effects.||
2592|046|S|   Tell your doctor right away if you have any serious side||
2592|047|S|effects, including: bone pain.||
2592|048|S|   This drug may rarely cause muscle problems (which can rarely||
2592|049|S|lead to a very serious condition called rhabdomyolysis). Tell||
2592|050|S|your doctor right away if you develop any of these symptoms:||
2592|051|S|muscle pain/tenderness/weakness (especially with fever or unusual||
2592|052|S|tiredness), signs of kidney problems (such as change in the||
2592|053|S|amount of urine).||
2592|054|S|   This medication may rarely cause gallbladder and other liver||
2592|055|S|problems. Tell your doctor right away if you notice any of these||
2592|056|S|serious side effects: nausea/vomiting that doesn't stop, loss of||
2592|057|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2592|058|S|urine.||
2592|059|S|   A very serious allergic reaction to this drug is rare.||
2592|060|S|However, get medical help right away if you notice any symptoms||
2592|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2592|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2592|063|S|breathing.||
2592|064|S|   This is not a complete list of possible side effects. If you||
2592|065|S|notice other effects not listed above, contact your doctor or||
2592|066|S|pharmacist.||
2592|067|S|   In the US -||
2592|068|S|   Call your doctor for medical advice about side effects. You||
2592|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2592|070|S|www.fda.gov/medwatch.||
2592|071|S|   In Canada - Call your doctor for medical advice about side||
2592|072|S|effects. You may report side effects to Health Canada at||
2592|073|S|1-866-234-2345.||
2592|074|B|||
2592|075|P|PRECAUTIONS:  Before taking elafibranor, tell your doctor or||
2592|076|P|pharmacist if you are allergic to it; or if you have any other||
2592|077|P|allergies. This product may contain inactive ingredients, which||
2592|078|P|can cause allergic reactions or other problems. Talk to your||
2592|079|P|pharmacist for more details.||
2592|080|P|   Before using this medication, tell your doctor or pharmacist||
2592|081|P|your medical history, especially of: other liver problems (such||
2592|082|P|as ascites, encephalopathy), muscle pain, osteoporosis.||
2592|083|P|   Before having surgery, tell your doctor or dentist about all||
2592|084|P|the products you use (including prescription drugs,||
2592|085|P|nonprescription drugs, and herbal products).||
2592|086|P|   Tell your doctor if you are pregnant or plan to become||
2592|087|P|pregnant. You should not become pregnant while using elafibranor.||
2592|088|P|Elafibranor may harm an unborn baby. Your doctor should order a||
2592|089|P|pregnancy test before you start this medication. Ask about||
2592|090|P|reliable forms of non-hormonal birth control (such as condoms,||
2592|091|P|diaphragm with spermicide) while using this medication and for 3||
2592|092|P|weeks after the last dose. If you become pregnant, talk to your||
2592|093|P|doctor right away about the risks and benefits of this||
2592|094|P|medication.||
2592|095|P|   It is unknown if this medication passes into breast milk.||
2592|096|P|Because of the possible risk to the infant, breastfeeding is not||
2592|097|P|recommended while using this medication and for 3 weeks after the||
2592|098|P|last dose. Consult your doctor before breastfeeding.||
2592|099|B|||
2592|100|I|DRUG INTERACTIONS:  See also How to Use section.||
2592|101|I|   Drug interactions may change how your medications work or||
2592|102|I|increase your risk for serious side effects. This document does||
2592|103|I|not contain all possible drug interactions. Keep a list of all||
2592|104|I|the products you use (including prescription/nonprescription||
2592|105|I|drugs and herbal products) and share it with your doctor and||
2592|106|I|pharmacist. Do not start, stop, or change the dosage of any||
2592|107|I|medicines without your doctor's approval.||
2592|108|I|   This medication may decrease the effectiveness of hormonal||
2592|109|I|birth control such as pills, patch, or ring. This could cause||
2592|110|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2592|111|I|use reliable backup birth control methods while using this||
2592|112|I|medication and for at least 3 weeks after the last dose. Also||
2592|113|I|tell your doctor if you have any new spotting or breakthrough||
2592|114|I|bleeding, because these may be signs that your birth control is||
2592|115|I|not working well.||
2592|116|B|||
2592|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2592|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2592|119|O|poison control center right away. US residents can call||
2592|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2592|121|B|||
2592|122|N|NOTES:  Do not share this medication with others.||
2592|123|N|   Lab and/or medical tests (such as liver function, CPK levels)||
2592|124|N|should be done before you start taking this medication and while||
2592|125|N|you are taking it. Keep all medical and lab appointments. Consult||
2592|126|N|your doctor for more details.||
2592|127|B|||
2592|128|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
2592|129|D|right away for a new dosing schedule. Do not double the dose to||
2592|130|D|catch up.||
2592|131|B|||
2592|132|R|STORAGE:  Different brands of this medication have different||
2592|133|R|storage needs. Check the product package for instructions on how||
2592|134|R|to store your brand, or ask your pharmacist. Keep all medications||
2592|135|R|away from children and pets.||
2592|136|R|   Do not flush medications down the toilet or pour them into a||
2592|137|R|drain unless instructed to do so. Properly discard this product||
2592|138|R|when it is expired or no longer needed. Consult your pharmacist||
2592|139|R|or local waste disposal company.||
2592|140|B|||
2592|141|A|Information last revised May 2025.||
2592|142|A|Copyright(c) 2025 First Databank, Inc.||
2592|143|B|||
2593|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2593|002|Z|does NOT have all possible information about this product. This||
2593|003|Z|information does not assure that this product is safe, effective,||
2593|004|Z|or appropriate for you. This information is not individual||
2593|005|Z|medical advice and does not substitute for the advice of your||
2593|006|Z|health care professional. Always ask your health care||
2593|007|Z|professional for complete information about this product and your||
2593|008|Z|specific health needs.||
2593|009|B|||
2593|010|T|IMETELSTAT - INJECTION||
2593|011|F|(IM-e-TEL-stat)||
2593|012|B|||
2593|013|C|COMMON BRAND NAME(S): Rytelo||
2593|014|B|||
2593|015|U|USES:  This medication is used to treat anemia in patients with a||
2593|016|U|group of blood/bone marrow disorders (myelodysplastic||
2593|017|U|syndromes-MDS). Imetelstat works by slowing or stopping the||
2593|018|U|growth of cancer cells. This effect may help reduce the need for||
2593|019|U|blood transfusions.||
2593|020|B|||
2593|021|H|HOW TO USE:  Read the Medication Guide provided by your||
2593|022|H|pharmacist before you start using imetelstat and each time you||
2593|023|H|get a treatment. If you have any questions, ask your doctor or||
2593|024|H|pharmacist.||
2593|025|H|   This medication is given by injection into a vein by a health||
2593|026|H|care professional. It is given as directed by your doctor,||
2593|027|H|usually once every 4 weeks. It is injected slowly into a vein||
2593|028|H|over 2 hours. The dosage is based on your weight and response to||
2593|029|H|treatment.||
2593|030|H|   Infusion reactions may happen during the infusion of this drug||
2593|031|H|and for some time afterward. Your doctor may prescribe other||
2593|032|H|medications (such as diphenhydramine, hydrocortisone) before each||
2593|033|H|treatment to help prevent these side effects. Tell your doctor||
2593|034|H|right away if you have any symptoms of infusion reactions such as||
2593|035|H|stomach pain, headache, joint pain, weakness, tiredness,||
2593|036|H|back/bone pain, chest pain, diarrhea, itching, redness, or hives.||
2593|037|H|Your doctor may give you other medications to help with these||
2593|038|H|side effects or may slow down or stop your treatment for some||
2593|039|H|time.||
2593|040|H|   Use this medication regularly to get the most benefit from it.||
2593|041|H|To help you remember, mark your calendar with a reminder.||
2593|042|H|   Tell your doctor if your condition gets worse.||
2593|043|B|||
2593|044|S|SIDE EFFECTS:  Tiredness, headache, or joint/bone/muscle pain may||
2593|045|S|occur. If any of these effects last or get worse, tell your||
2593|046|S|doctor or pharmacist promptly.||
2593|047|S|   Remember that this medication has been prescribed because your||
2593|048|S|doctor has judged that the benefit to you is greater than the||
2593|049|S|risk of side effects. Many people using this medication do not||
2593|050|S|have serious side effects.||
2593|051|S|   This medication may cause a low number of platelets and white||
2593|052|S|blood cells. This can cause easy bruising/bleeding or decrease||
2593|053|S|your body's ability to fight an infection. Tell your doctor right||
2593|054|S|away if you have any of the following symptoms: new/worsening||
2593|055|S|bruising/bleeding, signs of infection (such as sore throat that||
2593|056|S|doesn't go away, fever, chills, burning/painful urination).||
2593|057|S|   Get medical help right away if you have any very serious side||
2593|058|S|effects, including: black/bloody stools, vomit that looks like||
2593|059|S|coffee grounds.||
2593|060|S|   A very serious allergic reaction to this drug is rare.||
2593|061|S|However, get medical help right away if you notice any symptoms||
2593|062|S|of a serious allergic reaction, including: rash, itching/swelling||
2593|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2593|064|S|breathing.||
2593|065|S|   This is not a complete list of possible side effects. If you||
2593|066|S|notice other effects not listed above, contact your doctor or||
2593|067|S|pharmacist.||
2593|068|S|   In the US -||
2593|069|S|   Call your doctor for medical advice about side effects. You||
2593|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2593|071|S|www.fda.gov/medwatch.||
2593|072|S|   In Canada - Call your doctor for medical advice about side||
2593|073|S|effects. You may report side effects to Health Canada at||
2593|074|S|1-866-234-2345.||
2593|075|B|||
2593|076|P|PRECAUTIONS:  Before using imetelstat, tell your doctor or||
2593|077|P|pharmacist if you are allergic to it; or if you have any other||
2593|078|P|allergies. This product may contain inactive ingredients, which||
2593|079|P|can cause allergic reactions or other problems. Talk to your||
2593|080|P|pharmacist for more details.||
2593|081|P|   Before using this medication, tell your doctor or pharmacist||
2593|082|P|your medical history, especially of: liver problems.||
2593|083|P|   Imetelstat can make you more likely to get infections or may||
2593|084|P|make current infections worse. Stay away from anyone who has an||
2593|085|P|infection that may easily spread (such as chickenpox, COVID-19,||
2593|086|P|measles, flu). Talk to your doctor if you have been exposed to an||
2593|087|P|infection or for more details.||
2593|088|P|   Tell your health care professional that you are using||
2593|089|P|imetelstat before having any immunizations/vaccinations. Avoid||
2593|090|P|contact with people who have recently received live vaccines||
2593|091|P|(such as flu vaccine inhaled through the nose).||
2593|092|P|   To lower the chance of getting cut, bruised, or injured, use||
2593|093|P|caution with sharp objects like razors and nail cutters, and||
2593|094|P|avoid activities such as contact sports.||
2593|095|P|   Before having surgery, tell your doctor or dentist about all||
2593|096|P|the products you use (including prescription drugs,||
2593|097|P|nonprescription drugs, and herbal products).||
2593|098|P|   Tell your doctor if you are pregnant or plan to become||
2593|099|P|pregnant. You should not become pregnant while using imetelstat.||
2593|100|P|Imetelstat may harm an unborn baby. Your doctor should order a||
2593|101|P|pregnancy test before you start this medication. Ask about||
2593|102|P|reliable forms of birth control while using this medication and||
2593|103|P|for 1 week after the last dose. If you become pregnant, talk to||
2593|104|P|your doctor right away about the risks and benefits of this||
2593|105|P|medication.||
2593|106|P|   It is unknown if this medication passes into breast milk.||
2593|107|P|Because of the possible risk to the infant, breastfeeding is not||
2593|108|P|recommended while using this drug and for 1 week after the last||
2593|109|P|dose. Consult your doctor before breastfeeding.||
2593|110|B|||
2593|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2593|112|I|medications work or increase your risk for serious side effects.||
2593|113|I|This document does not contain all possible drug interactions.||
2593|114|I|Keep a list of all the products you use (including||
2593|115|I|prescription/nonprescription drugs and herbal products) and share||
2593|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
2593|117|I|the dosage of any medicines without your doctor's approval.||
2593|118|B|||
2593|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2593|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2593|121|O|poison control center right away. US residents can call||
2593|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2593|123|B|||
2593|124|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2593|125|N|liver function) should be done before you start using this||
2593|126|N|medication and while you are using it. Keep all medical and lab||
2593|127|N|appointments. Consult your doctor for more details.||
2593|128|B|||
2593|129|D|MISSED DOSE:  It is important to get each dose of this medication||
2593|130|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2593|131|D|right away for a new dosing schedule.||
2593|132|B|||
2593|133|R|STORAGE:  Not applicable. This medication is given in a hospital||
2593|134|R|or clinic and will not be stored at home.||
2593|135|B|||
2593|136|M|MEDICAL ALERT:  Your condition can cause complications in a||
2593|137|M|medical emergency. For information about enrolling in MedicAlert,||
2593|138|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2593|139|B|||
2593|140|A|Information last revised October 2024.||
2593|141|A|Copyright(c) 2025 First Databank, Inc.||
2593|142|B|||
2594|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2594|002|Z|does NOT have all possible information about this product. This||
2594|003|Z|information does not assure that this product is safe, effective,||
2594|004|Z|or appropriate for you. This information is not individual||
2594|005|Z|medical advice and does not substitute for the advice of your||
2594|006|Z|health care professional. Always ask your health care||
2594|007|Z|professional for complete information about this product and your||
2594|008|Z|specific health needs.||
2594|009|B|||
2594|010|T|INSULIN ICODEC - INJECTION||
2594|011|B|||
2594|012|U|USES:  Insulin icodec is used with a proper diet and exercise||
2594|013|U|program to control high blood sugar in people with diabetes.||
2594|014|U|Controlling high blood sugar helps prevent kidney damage,||
2594|015|U|blindness, nerve problems, loss of limbs, and sexual function||
2594|016|U|problems. Proper control of diabetes may also lessen your risk of||
2594|017|U|a heart attack or stroke.||
2594|018|U|   Insulin icodec is a man-made product that is similar to human||
2594|019|U|insulin. It replaces the insulin that your body would normally||
2594|020|U|make. It acts longer than regular insulin, providing a low,||
2594|021|U|steady level of insulin. It works by helping blood sugar||
2594|022|U|(glucose) get into cells so your body can use it for energy.||
2594|023|U|Insulin icodec may be used with a shorter-acting insulin product.||
2594|024|U|It may also be used alone or with other diabetes drugs.||
2594|025|B|||
2594|026|H|HOW TO USE:  Read the Patient Information Leaflet and||
2594|027|H|Instructions for Use if available from your pharmacist before you||
2594|028|H|start using this medication and each time you get a refill. Ask||
2594|029|H|your health care professional how to prepare and use this||
2594|030|H|medication. If you have any questions, ask your doctor or||
2594|031|H|pharmacist.||
2594|032|H|   Inject this medication under the skin as directed by your||
2594|033|H|doctor, usually every 7 days. The injection is given in the upper||
2594|034|H|arms, thighs, or abdomen (except for a 2-inch area around your||
2594|035|H|belly button). Do not inject into a vein or muscle because very||
2594|036|H|low blood sugar (hypoglycemia) may occur. The dosage is based on||
2594|037|H|your medical condition and response to treatment. Measure each||
2594|038|H|dose very carefully because even small changes in the amount of||
2594|039|H|insulin may have a large effect on your blood sugar.||
2594|040|H|   Before using, check this product for cloudiness, particles, or||
2594|041|H|discoloration. If you see any of these things, do not use the||
2594|042|H|liquid. Before injecting each dose, clean the skin you are going||
2594|043|H|to inject into (the injection site) with rubbing alcohol. Change||
2594|044|H|the injection site each time to lessen injury under the skin (for||
2594|045|H|example, pits/lumps or thickened skin). Do not inject into skin||
2594|046|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
2594|047|H|not rub the injection site after a shot. Do not inject cold||
2594|048|H|insulin because this can be painful. The insulin container you||
2594|049|H|are currently using can be kept at room temperature. Learn how to||
2594|050|H|store and discard medical supplies safely.||
2594|051|H|   Do not mix this product with other insulins or solutions, or||
2594|052|H|use it in an insulin pump.||
2594|053|H|   Do not change brands or types of insulin without directions on||
2594|054|H|how to do so from your doctor.||
2594|055|H|   Do not share your pen device with another person, even if the||
2594|056|H|needle is changed. You may give other people a serious infection||
2594|057|H|or get a serious infection from them.||
2594|058|H|   Use this medication regularly to get the most benefit from it.||
2594|059|H|To help you remember, use it on the same day each week. Mark your||
2594|060|H|calendar with a reminder.||
2594|061|H|   Tell your doctor if your condition does not get better or if||
2594|062|H|it gets worse (your blood sugar is too high or too low).||
2594|063|B|||
2594|064|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
2594|065|S|itching, irritation), weight gain, or swelling of the||
2594|066|S|ankles/feet/hands may occur. If any of these effects last or get||
2594|067|S|worse, tell your doctor or pharmacist promptly.||
2594|068|S|   Remember that this medication has been prescribed because your||
2594|069|S|doctor has judged that the benefit to you is greater than the||
2594|070|S|risk of side effects. Many people using this medication do not||
2594|071|S|have serious side effects.||
2594|072|S|   Tell your doctor right away if you have any serious side||
2594|073|S|effects, including: signs of low potassium level in the blood||
2594|074|S|(such as muscle cramps, weakness, irregular heartbeat).||
2594|075|S|   This medication can cause low blood sugar (hypoglycemia),||
2594|076|S|especially 2 to 4 days after using this insulin. This may occur||
2594|077|S|if you do not get enough calories from food or if you do||
2594|078|S|unusually heavy exercise. Symptoms of low blood sugar include||
2594|079|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
2594|080|S|dizziness, or tingling hands/feet. It is a good habit to carry||
2594|081|S|glucose tablets or gel to treat low blood sugar. If you don't||
2594|082|S|have these reliable forms of glucose, rapidly raise your blood||
2594|083|S|sugar by eating a quick source of sugar such as table sugar,||
2594|084|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
2594|085|S|doctor right away about the reaction and the use of this product.||
2594|086|S|To help prevent low blood sugar, eat meals on a regular schedule,||
2594|087|S|and do not skip meals. Check with your doctor or pharmacist to||
2594|088|S|find out what you should do if you miss a meal.||
2594|089|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
2594|090|S|thirst/urination. If these symptoms occur, tell your doctor right||
2594|091|S|away. Your dosage may need to be increased.||
2594|092|S|   A very serious allergic reaction to this drug is rare.||
2594|093|S|However, get medical help right away if you notice any symptoms||
2594|094|S|of a serious allergic reaction, including: rash, itching/swelling||
2594|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2594|096|S|breathing.||
2594|097|S|   This is not a complete list of possible side effects. If you||
2594|098|S|notice other effects not listed above, contact your doctor or||
2594|099|S|pharmacist.||
2594|100|S|   In the US -||
2594|101|S|   Call your doctor for medical advice about side effects. You||
2594|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2594|103|S|www.fda.gov/medwatch.||
2594|104|S|   In Canada - Call your doctor for medical advice about side||
2594|105|S|effects. You may report side effects to Health Canada at||
2594|106|S|1-866-234-2345.||
2594|107|B|||
2594|108|P|PRECAUTIONS:  Before using insulin icodec, tell your doctor or||
2594|109|P|pharmacist if you are allergic to it; or if you have any other||
2594|110|P|allergies. This product may contain inactive ingredients, which||
2594|111|P|can cause allergic reactions or other problems. Talk to your||
2594|112|P|pharmacist for more details.||
2594|113|P|   Before using this medication, tell your doctor or pharmacist||
2594|114|P|your medical history, especially of: kidney disease, liver||
2594|115|P|disease.||
2594|116|P|   You may experience blurred vision, dizziness, or drowsiness||
2594|117|P|due to extremely low or high blood sugar. Do not drive, use||
2594|118|P|machinery, or do anything that needs alertness or clear vision||
2594|119|P|until you can do it safely.||
2594|120|P|   Limit alcohol while using this medication because it can||
2594|121|P|increase your risk of developing low blood sugar.||
2594|122|P|   It may be harder to control your blood sugar when your body is||
2594|123|P|stressed (such as due to fever, infection, injury, or surgery).||
2594|124|P|Consult your doctor because this may require a change in your||
2594|125|P|treatment plan, medications, or blood sugar testing.||
2594|126|P|   Before having surgery, tell your doctor or dentist about all||
2594|127|P|the products you use (including prescription drugs,||
2594|128|P|nonprescription drugs, and herbal products).||
2594|129|P|   Check your blood sugar before and after exercise. You may need||
2594|130|P|a snack before exercising.||
2594|131|P|   If traveling across time zones, ask your doctor about how to||
2594|132|P|adjust your insulin schedule. Take extra insulin and supplies||
2594|133|P|with you.||
2594|134|P|   Older adults may be more sensitive to the side effects of this||
2594|135|P|drug, especially low blood sugar.||
2594|136|P|   During pregnancy, this medication should be used only when||
2594|137|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2594|138|P|benefits with your doctor.||
2594|139|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
2594|140|P|your doctor for managing your blood sugar while pregnant. Your||
2594|141|P|doctor may change your diabetes treatment during your pregnancy||
2594|142|P|(such as diet and medications including insulin).||
2594|143|P|   It is unknown if this drug passes into breast milk. Consult||
2594|144|P|your doctor before breastfeeding.||
2594|145|B|||
2594|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2594|147|I|medications work or increase your risk for serious side effects.||
2594|148|I|This document does not contain all possible drug interactions.||
2594|149|I|Keep a list of all the products you use (including||
2594|150|I|prescription/nonprescription drugs and herbal products) and share||
2594|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
2594|152|I|the dosage of any medicines without your doctor's approval.||
2594|153|I|   Beta blocker medications (such as metoprolol, propranolol,||
2594|154|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
2594|155|I|heartbeat you would usually feel when your blood sugar falls too||
2594|156|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
2594|157|I|dizziness, hunger, or sweating, are not affected by these drugs.||
2594|158|I|   Many drugs can affect your blood sugar, making it harder to||
2594|159|I|control. Before you start, stop, or change any medication, talk||
2594|160|I|with your doctor or pharmacist about how the medication may||
2594|161|I|affect your blood sugar. Check your blood sugar regularly as||
2594|162|I|directed and share the results with your doctor. Tell your doctor||
2594|163|I|right away if you have symptoms of high or low blood sugar. (See||
2594|164|I|also Side Effects section.) Your doctor may need to adjust your||
2594|165|I|diabetes medication, exercise program, or diet.||
2594|166|B|||
2594|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2594|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2594|169|O|poison control center right away. US residents can call||
2594|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2594|171|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
2594|172|O|sweating, loss of consciousness.||
2594|173|B|||
2594|174|N|NOTES:  Do not share this medication with others.||
2594|175|N|   Attend a diabetes education program to learn more about how to||
2594|176|N|manage your diabetes with medications, diet, exercise, and||
2594|177|N|regular medical exams.||
2594|178|N|   Learn the symptoms of high and low blood sugar and how to||
2594|179|N|treat low blood sugar. Check your blood sugar regularly as||
2594|180|N|directed and share the results with your doctor.||
2594|181|N|   Lab and/or medical tests (such as liver/kidney function,||
2594|182|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
2594|183|N|should be done while you are using this medication. Keep all||
2594|184|N|medical and lab appointments.||
2594|185|B|||
2594|186|D|MISSED DOSE:  It is very important to follow your insulin regimen||
2594|187|D|exactly. Ask your doctor ahead of time what you should do if you||
2594|188|D|miss a dose of insulin.||
2594|189|B|||
2594|190|R|STORAGE:  It is best to refrigerate all unopened insulin||
2594|191|R|products. Unopened insulin icodec may also be stored at room||
2594|192|R|temperature. If stored at room temperature, discard after 84||
2594|193|R|days. Opened insulin icodec may be stored in the refrigerator or||
2594|194|R|at room temperature. Throw away all opened insulin icodec after||
2594|195|R|84 days, even if there is insulin left. Also throw away all||
2594|196|R|insulin products after the expiration date on the package. Do not||
2594|197|R|freeze, and do not use insulin that has been frozen.||
2594|198|R|   Protect insulin from light and heat. Do not store in the||
2594|199|R|bathroom. Keep all medications away from children and pets.||
2594|200|R|   Do not flush medications down the toilet or pour them into a||
2594|201|R|drain unless instructed to do so. Properly discard this product||
2594|202|R|when it is expired or no longer needed. Consult your pharmacist||
2594|203|R|or local waste disposal company.||
2594|204|B|||
2594|205|M|MEDICAL ALERT:  Your condition can cause complications in a||
2594|206|M|medical emergency. For information about enrolling in MedicAlert,||
2594|207|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2594|208|B|||
2594|209|A|Information last revised May 2025.||
2594|210|A|Copyright(c) 2025 First Databank, Inc.||
2594|211|B|||
2595|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2595|002|Z|does NOT have all possible information about this product. This||
2595|003|Z|information does not assure that this product is safe, effective,||
2595|004|Z|or appropriate for you. This information is not individual||
2595|005|Z|medical advice and does not substitute for the advice of your||
2595|006|Z|health care professional. Always ask your health care||
2595|007|Z|professional for complete information about this product and your||
2595|008|Z|specific health needs.||
2595|009|B|||
2595|010|T|SOFPIRONIUM - TOPICAL||
2595|011|F|(SOF-pir-OH-nee-um)||
2595|012|B|||
2595|013|C|COMMON BRAND NAME(S): Sofdra||
2595|014|B|||
2595|015|U|USES:  Sofpironium is used to treat excessive sweating from your||
2595|016|U|underarms. It works on the sweat glands to reduce sweating.||
2595|017|U|Sofpironium belongs to a class of drugs known as||
2595|018|U|anticholinergics.||
2595|019|B|||
2595|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
2595|021|H|Instructions for Use if available from your pharmacist before you||
2595|022|H|start using sofpironium and each time you get a refill. If you||
2595|023|H|have any questions, ask your doctor or pharmacist.||
2595|024|H|   This medication is for use on the skin of the underarms only.||
2595|025|H|Do not apply this medication to other areas of the body. Follow||
2595|026|H|the instructions for priming the pump if you are using it for the||
2595|027|H|first time.||
2595|028|H|   Do not apply this medication if you have shaved your underarms||
2595|029|H|or applied deodorant within the last 8 hours. Wait at least 30||
2595|030|H|minutes after exercising, showering, or washing your underarms||
2595|031|H|before applying this medication.||
2595|032|H|   Pump this medication into the applicator cup as directed. Do||
2595|033|H|not pump more than 1 pump of this medication into the applicator||
2595|034|H|at a time. Keeping the applicator level, use it to apply the||
2595|035|H|medication to clean, dry skin of the underarms as directed by||
2595|036|H|your doctor, usually once daily at bedtime. Do not apply to||
2595|037|H|broken skin. Do not spread the medication with your fingers or||
2595|038|H|hand. After applying this medication, rinse the applicator cup||
2595|039|H|with running water and then pat dry with a tissue. Replace the||
2595|040|H|applicator and cap back onto the bottle. Wash your hands||
2595|041|H|thoroughly with soap and water.||
2595|042|H|   Wait 5 minutes for the application site to dry completely||
2595|043|H|before dressing. This medication is flammable until dry. Avoid||
2595|044|H|smoking or being near open flames while using the medication and||
2595|045|H|until the medication has dried.||
2595|046|H|   After applying the medication, do not touch your underarms and||
2595|047|H|wait at least 8 hours before showering or washing your underarms.||
2595|048|H|Do not cover the area with plastic or waterproof bandages unless||
2595|049|H|directed to do so by your doctor.||
2595|050|H|   Use this medication regularly to get the most benefit from it.||
2595|051|H|To help you remember, use it at the same time each day.||
2595|052|H|   Tell your doctor if your condition does not get better or if||
2595|053|H|it gets worse.||
2595|054|B|||
2595|055|S|SIDE EFFECTS:  Redness, burning/stinging, or itching at the||
2595|056|S|application site may occur. Dry mouth or blurred vision may also||
2595|057|S|occur. If any of these effects last or get worse, tell your||
2595|058|S|doctor or pharmacist promptly.||
2595|059|S|   Remember that this medication has been prescribed because your||
2595|060|S|doctor has judged that the benefit to you is greater than the||
2595|061|S|risk of side effects. Many people using this medication do not||
2595|062|S|have serious side effects.||
2595|063|S|   Tell your doctor right away if you have any serious side||
2595|064|S|effects, including: difficulty urinating (such as weak stream or||
2595|065|S|drips, frequent urination, full bladder).||
2595|066|S|   A very serious allergic reaction to this drug is rare.||
2595|067|S|However, get medical help right away if you notice any symptoms||
2595|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2595|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2595|070|S|breathing.||
2595|071|S|   This is not a complete list of possible side effects. If you||
2595|072|S|notice other effects not listed above, contact your doctor or||
2595|073|S|pharmacist.||
2595|074|S|   In the US -||
2595|075|S|   Call your doctor for medical advice about side effects. You||
2595|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2595|077|S|www.fda.gov/medwatch.||
2595|078|S|   In Canada - Call your doctor for medical advice about side||
2595|079|S|effects. You may report side effects to Health Canada at||
2595|080|S|1-866-234-2345.||
2595|081|B|||
2595|082|P|PRECAUTIONS:  Before using sofpironium, tell your doctor or||
2595|083|P|pharmacist if you are allergic to it; or if you have any other||
2595|084|P|allergies. This product may contain inactive ingredients, which||
2595|085|P|can cause allergic reactions or other problems. Talk to your||
2595|086|P|pharmacist for more details.||
2595|087|P|   Before using this medication, tell your doctor or pharmacist||
2595|088|P|your medical history, especially of: high pressure in the eye||
2595|089|P|(glaucoma), a certain muscle/nerve disease (myasthenia gravis),||
2595|090|P|Sjogren's syndrome, stomach/intestinal problems (such as||
2595|091|P|blockage, ulcerative colitis), difficulty urinating (such as due||
2595|092|P|to enlarged prostate, bladder problems), kidney problems.||
2595|093|P|   This drug may cause temporary blurred vision. Do not drive,||
2595|094|P|use machinery, or do anything that needs clear vision until you||
2595|095|P|can do it safely.||
2595|096|P|   Sofpironium may make you sweat less, making you more likely to||
2595|097|P|get heat stroke. If you notice you are not sweating on your body||
2595|098|P|in very warm or hot weather, stop using this medication. Avoid||
2595|099|P|doing things that may cause you to overheat, such as hard work or||
2595|100|P|exercise in hot weather, or using hot tubs. When the weather is||
2595|101|P|hot, drink a lot of fluids and dress lightly. If you overheat,||
2595|102|P|quickly look for a place to cool down and rest. Get medical help||
2595|103|P|right away if you have a fever that does not go away, mental/mood||
2595|104|P|changes, headache, or dizziness.||
2595|105|P|   Before having surgery, tell your doctor or dentist about all||
2595|106|P|the products you use (including prescription drugs,||
2595|107|P|nonprescription drugs, and herbal products).||
2595|108|P|   During pregnancy, this medication should be used only when||
2595|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
2595|110|P|   It is unknown if this medication passes into breast milk.||
2595|111|P|Consult your doctor before breastfeeding.||
2595|112|B|||
2595|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2595|114|I|medications work or increase your risk for serious side effects.||
2595|115|I|This document does not contain all possible drug interactions.||
2595|116|I|Keep a list of all the products you use (including||
2595|117|I|prescription/nonprescription drugs and herbal products) and share||
2595|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
2595|119|I|the dosage of any medicines without your doctor's approval.||
2595|120|B|||
2595|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2595|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2595|123|O|poison control center right away. US residents can call||
2595|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2595|125|B|||
2595|126|N|NOTES:  Do not share this medication with others.||
2595|127|B|||
2595|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2595|129|D|If it is near the time of the next dose, skip the missed dose.||
2595|130|D|Use your next dose at the regular time. Do not double the dose to||
2595|131|D|catch up.||
2595|132|B|||
2595|133|R|STORAGE:  Store upright at room temperature. This medication is||
2595|134|R|flammable. Keep it away from heat and open flame. Keep all||
2595|135|R|medications away from children and pets.||
2595|136|R|   Do not flush medications down the toilet or pour them into a||
2595|137|R|drain unless instructed to do so. Properly discard this product||
2595|138|R|when it is expired or no longer needed. Consult your pharmacist||
2595|139|R|or local waste disposal company.||
2595|140|B|||
2595|141|A|Information last revised October 2025.||
2595|142|A|Copyright(c) 2025 First Databank, Inc.||
2595|143|B|||
2596|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2596|002|Z|does NOT have all possible information about this product. This||
2596|003|Z|information does not assure that this product is safe, effective,||
2596|004|Z|or appropriate for you. This information is not individual||
2596|005|Z|medical advice and does not substitute for the advice of your||
2596|006|Z|health care professional. Always ask your health care||
2596|007|Z|professional for complete information about this product and your||
2596|008|Z|specific health needs.||
2596|009|B|||
2596|010|T|ENSIFENTRINE SUSPENSION - INHALATION||
2596|011|F|(EN-si-FEN-treen)||
2596|012|B|||
2596|013|C|COMMON BRAND NAME(S): Ohtuvayre||
2596|014|B|||
2596|015|U|USES:  This medication is used to treat and control symptoms||
2596|016|U|(wheezing and shortness of breath) caused by ongoing lung disease||
2596|017|U|(chronic obstructive pulmonary disease-COPD which includes||
2596|018|U|bronchitis and emphysema). Ensifentrine works by reducing the||
2596|019|U|swelling of the airways and the muscles around the airways so you||
2596|020|U|can breathe more easily. Controlling symptoms of breathing||
2596|021|U|problems can decrease time lost from work or school.||
2596|022|U|   This medication must be used regularly to be effective. It||
2596|023|U|does not work right away and should not be used to relieve sudden||
2596|024|U|shortness of breath or wheezing. If sudden breathing problems||
2596|025|U|occur, use your quick-relief inhaler (such as albuterol, also||
2596|026|U|called salbutamol in some countries) as prescribed.||
2596|027|B|||
2596|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2596|029|H|from your pharmacist before you start using ensifentrine and each||
2596|030|H|time you get a refill. Follow the illustrated directions for the||
2596|031|H|proper use of this medication. This medication is used with a||
2596|032|H|special breathing machine called a nebulizer that changes the||
2596|033|H|suspension to a fine mist that you inhale. Make sure you||
2596|034|H|understand how to operate the breathing machine and how to||
2596|035|H|properly clean it to prevent infections. If you have any||
2596|036|H|questions, ask your doctor, pharmacist, or respiratory therapist.||
2596|037|H|   Before using, check this product for particles or||
2596|038|H|discoloration. If either is present, do not use the liquid. Do||
2596|039|H|not mix this medication with other solutions or products in the||
2596|040|H|nebulizer.||
2596|041|H|   Shake the container well before use. Using a mouthpiece with||
2596|042|H|the nebulizer, inhale this medication by mouth as directed by||
2596|043|H|your doctor, usually twice daily. While inhaling this medication,||
2596|044|H|breathe calmly and deeply until the mist stops, usually over 5 to||
2596|045|H|7 minutes. Do not swallow or inject this medication. Discard any||
2596|046|H|unused medication. Do not save for future use.||
2596|047|H|   Use this medication regularly to get the most benefit from it.||
2596|048|H|To help you remember, use it at the same times each day. Do not||
2596|049|H|increase your dose, use it more often, or stop using this||
2596|050|H|medication without first consulting your doctor.||
2596|051|H|   Learn which of your inhalers/medications you should use every||
2596|052|H|day and which you should use if your breathing suddenly worsens||
2596|053|H|(quick-relief drugs). Ask your doctor ahead of time what you||
2596|054|H|should do if you have new or worsening cough or shortness of||
2596|055|H|breath, wheezing, increased sputum, waking up at night with||
2596|056|H|trouble breathing, if you use your quick-relief inhaler more||
2596|057|H|often, or if your quick-relief inhaler does not seem to be||
2596|058|H|working well. Learn when you can treat sudden breathing problems||
2596|059|H|by yourself and when you must get medical help right away.||
2596|060|H|   Tell your doctor if you do not get better or if you get worse.||
2596|061|B|||
2596|062|S|SIDE EFFECTS:  Back pain or diarrhea may occur. If either of||
2596|063|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2596|064|S|promptly.||
2596|065|S|   Remember that this medication has been prescribed because your||
2596|066|S|doctor has judged that the benefit to you is greater than the||
2596|067|S|risk of side effects. Many people using this medication do not||
2596|068|S|have serious side effects.||
2596|069|S|   This medication may raise your blood pressure. Check your||
2596|070|S|blood pressure regularly and tell your doctor if the results are||
2596|071|S|high.||
2596|072|S|   Rarely, this medication may cause sudden severe worsening of||
2596|073|S|breathing problems right after you use it. If this occurs, use||
2596|074|S|your quick-relief inhaler and get medical help right away.||
2596|075|S|   Tell your doctor right away if you have any serious side||
2596|076|S|effects, including: mental/mood changes (such as nervousness,||
2596|077|S|depression, thoughts of suicide), trouble sleeping.||
2596|078|S|   A very serious allergic reaction to this drug is rare.||
2596|079|S|However, get medical help right away if you notice any symptoms||
2596|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2596|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2596|082|S|breathing.||
2596|083|S|   This is not a complete list of possible side effects. If you||
2596|084|S|notice other effects not listed above, contact your doctor or||
2596|085|S|pharmacist.||
2596|086|S|   In the US -||
2596|087|S|   Call your doctor for medical advice about side effects. You||
2596|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2596|089|S|www.fda.gov/medwatch.||
2596|090|S|   In Canada - Call your doctor for medical advice about side||
2596|091|S|effects. You may report side effects to Health Canada at||
2596|092|S|1-866-234-2345.||
2596|093|B|||
2596|094|P|PRECAUTIONS:  Before using ensifentrine, tell your doctor or||
2596|095|P|pharmacist if you are allergic to it; or if you have any other||
2596|096|P|allergies. This product may contain inactive ingredients, which||
2596|097|P|can cause allergic reactions or other problems. Talk to your||
2596|098|P|pharmacist for more details.||
2596|099|P|   Before using this medication, tell your doctor or pharmacist||
2596|100|P|your medical history, especially of: liver problems, mental/mood||
2596|101|P|disorders (depression, thoughts of suicide).||
2596|102|P|   Before having surgery, tell your doctor or dentist about all||
2596|103|P|the products you use (including prescription drugs,||
2596|104|P|nonprescription drugs, and herbal products).||
2596|105|P|   During pregnancy, this medication should be used only when||
2596|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
2596|107|P|   It is unknown if this medication passes into breast milk.||
2596|108|P|Consult your doctor before breastfeeding.||
2596|109|B|||
2596|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2596|111|I|medications work or increase your risk for serious side effects.||
2596|112|I|This document does not contain all possible drug interactions.||
2596|113|I|Keep a list of all the products you use (including||
2596|114|I|prescription/nonprescription drugs and herbal products) and share||
2596|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
2596|116|I|the dosage of any medicines without your doctor's approval.||
2596|117|B|||
2596|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2596|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2596|120|O|poison control center right away. US residents can call||
2596|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2596|122|O|Symptoms of overdose may include: headache, fast/pounding||
2596|123|O|heartbeat.||
2596|124|B|||
2596|125|N|NOTES:  Do not share this medication with others.||
2596|126|N|   Lab and/or medical tests (such as lung function, blood||
2596|127|N|pressure, liver function) may be done while you are using this||
2596|128|N|medication. Keep all medical and lab appointments. Consult your||
2596|129|N|doctor for more details.||
2596|130|B|||
2596|131|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2596|132|D|If it is near the time of the next dose, skip the missed dose.||
2596|133|D|Use your next dose at the regular time. Do not double the dose to||
2596|134|D|catch up.||
2596|135|B|||
2596|136|R|STORAGE:  Store at room temperature away from light and heat.||
2596|137|R|Keep the medication in the foil pouch until ready to use. Do not||
2596|138|R|freeze. Keep all medications away from children and pets.||
2596|139|R|   Do not flush medications down the toilet or pour them into a||
2596|140|R|drain unless instructed to do so. Properly discard this product||
2596|141|R|when it is expired or no longer needed. Consult your pharmacist||
2596|142|R|or local waste disposal company.||
2596|143|B|||
2596|144|A|Information last revised January 2025.||
2596|145|A|Copyright(c) 2025 First Databank, Inc.||
2596|146|B|||
2597|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2597|002|Z|does NOT have all possible information about this product. This||
2597|003|Z|information does not assure that this product is safe, effective,||
2597|004|Z|or appropriate for you. This information is not individual||
2597|005|Z|medical advice and does not substitute for the advice of your||
2597|006|Z|health care professional. Always ask your health care||
2597|007|Z|professional for complete information about this product and your||
2597|008|Z|specific health needs.||
2597|009|B|||
2597|010|T|DONANEMAB - INJECTION||
2597|011|F|(do-NAN-e-mab)||
2597|012|B|||
2597|013|C|COMMON BRAND NAME(S): Kisunla||
2597|014|B|||
2597|015|W|WARNING:  This medication may increase your risk of serious||
2597|016|W|(possibly fatal) side effects such as temporary swelling of the||
2597|017|W|brain, or small spots of bleeding in or on the surface of the||
2597|018|W|brain. These side effects are also known as amyloid-related||
2597|019|W|imaging abnormalities (ARIA). Your doctor may order a genetic||
2597|020|W|test to measure your risk for ARIA before you start this||
2597|021|W|medication. If the genetic test shows you are at greater risk,||
2597|022|W|your doctor should discuss with you the risks and benefits of||
2597|023|W|starting donanemab. Your doctor will do magnetic resonance||
2597|024|W|imaging (MRI) scans before and during treatment to check for||
2597|025|W|these side effects. If you are also taking medications that can||
2597|026|W|cause bleeding/bruising (including antiplatelet drugs such as||
2597|027|W|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
2597|028|W|such as warfarin/dabigatran), your doctor will monitor you more||
2597|029|W|closely for bleeding. ARIA usually go away over time. They do not||
2597|030|W|always cause symptoms, but tell your doctor right away if you||
2597|031|W|develop symptoms such as headache, dizziness, nausea, confusion,||
2597|032|W|seizures, trouble walking, or vision changes.||
2597|033|B|||
2597|034|U|USES:  This medication is used to treat Alzheimer's disease. It||
2597|035|U|is thought to work by decreasing a certain substance (amyloid||
2597|036|U|beta) that builds up in the brain of a person with Alzheimer's||
2597|037|U|disease. Donanemab belongs to a class of drugs known as||
2597|038|U|monoclonal antibodies. This medication is not a cure for||
2597|039|U|Alzheimer's disease. It may help slow down worsening of this||
2597|040|U|disease and may delay disability.||
2597|041|B|||
2597|042|H|HOW TO USE:  Read the Medication Guide provided by your||
2597|043|H|pharmacist before you start using donanemab and each time you||
2597|044|H|receive an injection. If you have any questions, ask your doctor||
2597|045|H|or pharmacist.||
2597|046|H|   This medication is given by injection into a vein as directed||
2597|047|H|by your doctor, usually every 4 weeks. The injection is given by||
2597|048|H|a health care professional, usually over 30 minutes. The dosage||
2597|049|H|is based on your medical condition and response to treatment.||
2597|050|H|   Infusion reactions may happen during the infusion of this drug||
2597|051|H|and for 30 minutes afterward. Your doctor may prescribe other||
2597|052|H|medications (such as antihistamines, acetaminophen,||
2597|053|H|corticosteroids) before each treatment to help prevent these side||
2597|054|H|effects. Tell your doctor right away if you have any symptoms of||
2597|055|H|infusion reactions such as chills, nausea, vomiting, shortness of||
2597|056|H|breath, sweating, skin irritation, headache, or chest pain. Your||
2597|057|H|doctor may slow down or stop your treatment for some time.||
2597|058|H|   Use this medication regularly to get the most benefit from it.||
2597|059|H|To help you remember, mark your calendar with a reminder.||
2597|060|B|||
2597|061|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2597|062|S|   Remember that this medication has been prescribed because your||
2597|063|S|doctor has judged that the benefit to you is greater than the||
2597|064|S|risk of side effects. Many people using this medication do not||
2597|065|S|have serious side effects.||
2597|066|S|   A very serious allergic reaction to this drug is rare.||
2597|067|S|However, get medical help right away if you notice any symptoms||
2597|068|S|of a serious allergic reaction, including: rash, itching/swelling||
2597|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2597|070|S|breathing.||
2597|071|S|   This is not a complete list of possible side effects. If you||
2597|072|S|notice other effects not listed above, contact your doctor or||
2597|073|S|pharmacist.||
2597|074|S|   In the US -||
2597|075|S|   Call your doctor for medical advice about side effects. You||
2597|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2597|077|S|www.fda.gov/medwatch.||
2597|078|S|   In Canada - Call your doctor for medical advice about side||
2597|079|S|effects. You may report side effects to Health Canada at||
2597|080|S|1-866-234-2345.||
2597|081|B|||
2597|082|P|PRECAUTIONS:  Before using donanemab, tell your doctor or||
2597|083|P|pharmacist if you are allergic to it; or if you have any other||
2597|084|P|allergies. This product may contain inactive ingredients, which||
2597|085|P|can cause allergic reactions or other problems. Talk to your||
2597|086|P|pharmacist for more details.||
2597|087|P|   Before using this medication, tell your doctor or pharmacist||
2597|088|P|your medical history.||
2597|089|P|   Before having surgery, tell your doctor or dentist about all||
2597|090|P|the products you use (including prescription drugs,||
2597|091|P|nonprescription drugs, and herbal products).||
2597|092|P|   During pregnancy, this medication should be used only when||
2597|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
2597|094|P|   It is unknown if this medication passes into breast milk.||
2597|095|P|Consult your doctor before breastfeeding.||
2597|096|B|||
2597|097|I|DRUG INTERACTIONS:  See also Warning section.||
2597|098|I|   Drug interactions may change how your medications work or||
2597|099|I|increase your risk for serious side effects. This document does||
2597|100|I|not contain all possible drug interactions. Keep a list of all||
2597|101|I|the products you use (including prescription/nonprescription||
2597|102|I|drugs and herbal products) and share it with your doctor and||
2597|103|I|pharmacist. Do not start, stop, or change the dosage of any||
2597|104|I|medicines without your doctor's approval.||
2597|105|B|||
2597|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2597|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2597|108|O|poison control center right away. US residents can call||
2597|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2597|110|B|||
2597|111|N|NOTES:  Lab and/or medical tests (such as genetic testing, MRI||
2597|112|N|scans, cognitive assessment) should be done before you start||
2597|113|N|using this medication and while you are using it. Keep all||
2597|114|N|medical and lab appointments.||
2597|115|B|||
2597|116|D|MISSED DOSE:  It is important to get each dose of this medication||
2597|117|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2597|118|D|right away for a new dosing schedule.||
2597|119|B|||
2597|120|R|STORAGE:  Not applicable. This medication is given in a hospital||
2597|121|R|or clinic and will not be stored at home.||
2597|122|B|||
2597|123|A|Information last revised October 2024.||
2597|124|A|Copyright(c) 2025 First Databank, Inc.||
2597|125|B|||
2598|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2598|002|Z|does NOT have all possible information about this product. This||
2598|003|Z|information does not assure that this product is safe, effective,||
2598|004|Z|or appropriate for you. This information is not individual||
2598|005|Z|medical advice and does not substitute for the advice of your||
2598|006|Z|health care professional. Always ask your health care||
2598|007|Z|professional for complete information about this product and your||
2598|008|Z|specific health needs.||
2598|009|B|||
2598|010|T|ROFLUMILAST CREAM - TOPICAL||
2598|011|F|(roe-FLUE-mi-last)||
2598|012|B|||
2598|013|C|COMMON BRAND NAME(S): Zoryve||
2598|014|B|||
2598|015|U|USES:  This medication is used to treat a certain skin condition||
2598|016|U|(atopic dermatitis). Roflumilast may help to reduce the swelling,||
2598|017|U|redness, and itching of the skin that occurs with this condition.||
2598|018|B|||
2598|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2598|020|H|from your pharmacist before you start using roflumilast and each||
2598|021|H|time you get a refill. If you have any questions, ask your doctor||
2598|022|H|or pharmacist.||
2598|023|H|   This medication is for use on the skin only. Apply this||
2598|024|H|medication to the affected area and rub in completely as directed||
2598|025|H|by your doctor, usually once daily. Wash your hands after||
2598|026|H|applying, unless you are treating your hands. Avoid getting this||
2598|027|H|medication in your eyes, mouth, or vagina. If this happens, rinse||
2598|028|H|right away with plenty of water.||
2598|029|H|   Use this medication regularly to get the most benefit from it.||
2598|030|H|To help you remember, use it at the same time each day.||
2598|031|H|   Tell your doctor if your condition does not get better or if||
2598|032|H|it gets worse.||
2598|033|B|||
2598|034|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, headache, or pain at||
2598|035|S|the application site may occur. If any of these effects last or||
2598|036|S|get worse, tell your doctor or pharmacist promptly.||
2598|037|S|   Remember that this medication has been prescribed because your||
2598|038|S|doctor has judged that the benefit to you is greater than the||
2598|039|S|risk of side effects. Many people using this medication do not||
2598|040|S|have serious side effects.||
2598|041|S|   A very serious allergic reaction to this drug is rare.||
2598|042|S|However, get medical help right away if you notice any symptoms||
2598|043|S|of a serious allergic reaction, including: rash, itching/swelling||
2598|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2598|045|S|breathing.||
2598|046|S|   This is not a complete list of possible side effects. If you||
2598|047|S|notice other effects not listed above, contact your doctor or||
2598|048|S|pharmacist.||
2598|049|S|   In the US -||
2598|050|S|   Call your doctor for medical advice about side effects. You||
2598|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2598|052|S|www.fda.gov/medwatch.||
2598|053|S|   In Canada - Call your doctor for medical advice about side||
2598|054|S|effects. You may report side effects to Health Canada at||
2598|055|S|1-866-234-2345.||
2598|056|B|||
2598|057|P|PRECAUTIONS:  Before using roflumilast, tell your doctor or||
2598|058|P|pharmacist if you are allergic to it; or if you have any other||
2598|059|P|allergies. This product may contain inactive ingredients, which||
2598|060|P|can cause allergic reactions or other problems. Talk to your||
2598|061|P|pharmacist for more details.||
2598|062|P|   Before using this medication, tell your doctor or pharmacist||
2598|063|P|your medical history, especially of: liver disease.||
2598|064|P|   Before having surgery, tell your doctor or dentist about all||
2598|065|P|the products you use (including prescription drugs,||
2598|066|P|nonprescription drugs, and herbal products).||
2598|067|P|   During pregnancy, this medication should be used only when||
2598|068|P|clearly needed. Discuss the risks and benefits with your doctor.||
2598|069|P|   It is unknown if this medication passes into breast milk.||
2598|070|P|Consult your doctor before breastfeeding.||
2598|071|B|||
2598|072|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2598|073|I|medications work or increase your risk for serious side effects.||
2598|074|I|This document does not contain all possible drug interactions.||
2598|075|I|Keep a list of all the products you use (including||
2598|076|I|prescription/nonprescription drugs and herbal products) and share||
2598|077|I|it with your doctor and pharmacist. Do not start, stop, or change||
2598|078|I|the dosage of any medicines without your doctor's approval.||
2598|079|B|||
2598|080|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2598|081|O|has overdosed and has serious symptoms such as passing out or||
2598|082|O|trouble breathing, call 911. Otherwise, call a poison control||
2598|083|O|center right away. US residents can call 1-800-222-1222. Canada||
2598|084|O|residents can call 1-844-764-7669.||
2598|085|B|||
2598|086|N|NOTES:  Do not share this medication with others.||
2598|087|B|||
2598|088|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
2598|089|D|remember. If it is near the time of the next dose, skip the||
2598|090|D|missed dose. Apply your next dose at the regular time. Do not||
2598|091|D|apply extra medicine to make up for the missed dose.||
2598|092|B|||
2598|093|R|STORAGE:  Store at room temperature. Keep all medications away||
2598|094|R|from children and pets.||
2598|095|R|   Do not flush medications down the toilet or pour them into a||
2598|096|R|drain unless instructed to do so. Properly discard this product||
2598|097|R|when it is expired or no longer needed. Consult your pharmacist||
2598|098|R|or local waste disposal company.||
2598|099|B|||
2598|100|A|Information last revised October 2025.||
2598|101|A|Copyright(c) 2025 First Databank, Inc.||
2598|102|B|||
2599|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2599|002|Z|does NOT have all possible information about this product. This||
2599|003|Z|information does not assure that this product is safe, effective,||
2599|004|Z|or appropriate for you. This information is not individual||
2599|005|Z|medical advice and does not substitute for the advice of your||
2599|006|Z|health care professional. Always ask your health care||
2599|007|Z|professional for complete information about this product and your||
2599|008|Z|specific health needs.||
2599|009|B|||
2599|010|T|CROVALIMAB - INJECTION||
2599|011|F|(kroe-VAL-i-mab)||
2599|012|B|||
2599|013|C|COMMON BRAND NAME(S): Piasky||
2599|014|B|||
2599|015|W|WARNING:  Crovalimab can lower your body's ability to fight||
2599|016|W|infections. It can increase your chance of getting a very serious||
2599|017|W|(possibly fatal) brain/spinal cord infection (meningitis). Get||
2599|018|W|medical help right away if you develop any signs of a severe||
2599|019|W|infection (including meningitis), such as nausea/vomiting that||
2599|020|W|doesn't stop, high fever, chills, severe headache, stiff neck,||
2599|021|W|mental/mood changes (such as confusion), muscle aches with||
2599|022|W|flu-like symptoms, eye sensitivity to light.||
2599|023|W|   You should get the vaccine for meningitis (meningococcal||
2599|024|W|vaccine) at least 2 weeks before you start crovalimab. If you||
2599|025|W|have been previously vaccinated for meningitis, ask your doctor||
2599|026|W|if you need to be vaccinated again before using this medication.||
2599|027|W|The vaccine will protect most people, but meningitis may occur||
2599|028|W|even in people who have been vaccinated. You should still watch||
2599|029|W|for signs of meningitis even if you receive the vaccine. Consult||
2599|030|W|your doctor for more details.||
2599|031|W|   To receive crovalimab in the United States, you must||
2599|032|W|understand, agree to, and carefully follow the requirements of||
2599|033|W|the REMS Program for this medication. If you live in Canada or||
2599|034|W|any other country, consult your doctor and pharmacist for your||
2599|035|W|country's regulations.||
2599|036|B|||
2599|037|U|USES:  Crovalimab is used to treat a certain blood disorder||
2599|038|U|(paroxysmal nocturnal hemoglobinuria). This disorder causes your||
2599|039|U|body's immune system to break down red blood cells, which results||
2599|040|U|in anemia. Crovalimab works by helping to block the body's||
2599|041|U|breakdown of red blood cells. This effect helps lessen symptoms||
2599|042|U|of anemia (such as tiredness, shortness of breath) and may reduce||
2599|043|U|the need for blood transfusions.||
2599|044|B|||
2599|045|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2599|046|H|Instructions for Use Leaflet provided by your pharmacist before||
2599|047|H|you start using crovalimab and each time you get an injection.||
2599|048|H|Carry the Patient Safety Card with you at all times during||
2599|049|H|treatment and for 11 months after your last dose of crovalimab.||
2599|050|H|If you have any questions, ask your doctor or pharmacist.||
2599|051|H|   This medication is given by injection into a vein by a health||
2599|052|H|care professional or by injection under the skin. The dosage is||
2599|053|H|based on your medical condition, weight, and response to||
2599|054|H|treatment. On day 1, the first dose is given by a slow injection||
2599|055|H|into a vein, usually over 60 to 90 minutes as directed by your||
2599|056|H|doctor.||
2599|057|H|   Infusion reactions may happen during the infusion of this drug||
2599|058|H|on day 1. Tell your doctor right away if you have any symptoms of||
2599|059|H|infusion reactions such as headache, pain at the infusion site,||
2599|060|H|swelling, bruising/bleeding, skin redness, itching, or rash. Your||
2599|061|H|doctor may slow down or stop your treatment for some time.||
2599|062|H|   Starting on day 2, all other doses are given by injection||
2599|063|H|under the skin as directed by your doctor, usually once weekly||
2599|064|H|for 5 doses, then once every 4 weeks. The injection under the||
2599|065|H|skin is given in the abdomen (except for a 2-inch area around||
2599|066|H|your belly button).||
2599|067|H|   If you are using this medication at home, learn all||
2599|068|H|preparation and usage instructions from your health care||
2599|069|H|professional and the product package. Do not shake the||
2599|070|H|medication. Before using, check this product for cloudiness,||
2599|071|H|particles, or discoloration. If you see any of these things, do||
2599|072|H|not use the liquid. Before injecting each dose, clean the skin||
2599|073|H|you are going to inject into (the injection site) with rubbing||
2599|074|H|alcohol. Change the injection site each time to lessen injury||
2599|075|H|under the skin. Do not inject into skin that is tender, bruised,||
2599|076|H|red, hard, or damaged or into moles or scars. To lessen bruising,||
2599|077|H|do not rub the injection site after a shot. Learn how to store||
2599|078|H|and discard medical supplies safely.||
2599|079|H|   Use this medication regularly to get the most benefit from it.||
2599|080|H|To help you remember, mark your calendar with a reminder.||
2599|081|H|   Do not stop using this medication without consulting your||
2599|082|H|doctor. Your condition may become worse when the drug is stopped.||
2599|083|H|If you do stop using this medication, your doctor will monitor||
2599|084|H|you for at least 20 weeks to make sure your condition does not||
2599|085|H|get worse. Consult your doctor for more details.||
2599|086|H|   Tell your doctor if your condition does not get better or if||
2599|087|H|it gets worse.||
2599|088|B|||
2599|089|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
2599|090|S|   Headache, diarrhea, pain at the injection site, or swelling||
2599|091|S|hands/ankles/feet may occur. If any of these effects last or get||
2599|092|S|worse, tell your doctor or pharmacist promptly.||
2599|093|S|   Remember that this medication has been prescribed because your||
2599|094|S|doctor has judged that the benefit to you is greater than the||
2599|095|S|risk of side effects. Many people using this medication do not||
2599|096|S|have serious side effects.||
2599|097|S|   This medication may lower your ability to fight infections.||
2599|098|S|This may make you more likely to get a serious (rarely fatal)||
2599|099|S|infection or make any infection you have worse. Tell your doctor||
2599|100|S|right away if you have any signs of infection (such as sore||
2599|101|S|throat that doesn't go away, fever, chills).||
2599|102|S|   If you have used a similar medication recently (C5 inhibitors||
2599|103|S|such as eculizumab, ravulizumab), you may be at increased risk||
2599|104|S|for other immune system problems. Tell your doctor right away if||
2599|105|S|you have symptoms such as: joint/muscle/bone pain,||
2599|106|S|numbness/tingling of the hands/feet, unusual tiredness/weakness,||
2599|107|S|stomach/abdominal pain.||
2599|108|S|   A very serious allergic reaction to this drug is rare.||
2599|109|S|However, get medical help right away if you notice any symptoms||
2599|110|S|of a serious allergic reaction, including: rash, itching/swelling||
2599|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2599|112|S|breathing.||
2599|113|S|   This is not a complete list of possible side effects. If you||
2599|114|S|notice other effects not listed above, contact your doctor or||
2599|115|S|pharmacist.||
2599|116|S|   In the US -||
2599|117|S|   Call your doctor for medical advice about side effects. You||
2599|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2599|119|S|www.fda.gov/medwatch.||
2599|120|S|   In Canada - Call your doctor for medical advice about side||
2599|121|S|effects. You may report side effects to Health Canada at||
2599|122|S|1-866-234-2345.||
2599|123|B|||
2599|124|P|PRECAUTIONS:  Before using crovalimab, tell your doctor or||
2599|125|P|pharmacist if you are allergic to it; or if you have any other||
2599|126|P|allergies. This product may contain inactive ingredients, which||
2599|127|P|can cause allergic reactions or other problems. Talk to your||
2599|128|P|pharmacist for more details.||
2599|129|P|   Before using this medication, tell your doctor or pharmacist||
2599|130|P|your medical history, especially of: current/recent infection.||
2599|131|P|   Crovalimab can make you more likely to get certain infections||
2599|132|P|(such as flu, colds, meningitis). Talk to your doctor for more||
2599|133|P|details.||
2599|134|P|   Tell your doctor your vaccine history and ask if you need to||
2599|135|P|get any vaccines before starting treatment with this medication.||
2599|136|P|Tell your health care professional that you are using crovalimab||
2599|137|P|before having any immunizations/vaccinations. Avoid contact with||
2599|138|P|people who have recently received live vaccines (such as flu||
2599|139|P|vaccine inhaled through the nose).||
2599|140|P|   Before having surgery, tell your doctor or dentist about all||
2599|141|P|the products you use (including prescription drugs,||
2599|142|P|nonprescription drugs, and herbal products).||
2599|143|P|   During pregnancy, this medication should be used only when||
2599|144|P|clearly needed. Discuss the risks and benefits with your doctor.||
2599|145|P|   It is unknown if this drug passes into breast milk. Because of||
2599|146|P|the possible risk to the infant, breastfeeding is not recommended||
2599|147|P|while using this drug and for 9 months after the last dose.||
2599|148|P|Consult your doctor before breastfeeding.||
2599|149|B|||
2599|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2599|151|I|medications work or increase your risk for serious side effects.||
2599|152|I|This document does not contain all possible drug interactions.||
2599|153|I|Keep a list of all the products you use (including||
2599|154|I|prescription/nonprescription drugs and herbal products) and share||
2599|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
2599|156|I|the dosage of any medicines without your doctor's approval.||
2599|157|B|||
2599|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2599|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2599|160|O|poison control center right away. US residents can call||
2599|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2599|162|B|||
2599|163|N|NOTES:  Lab and/or medical tests (such as LDH level, complete||
2599|164|N|blood count) should be done while you are using this medication.||
2599|165|N|Keep all medical and lab appointments. Consult your doctor for||
2599|166|N|more details.||
2599|167|B|||
2599|168|D|MISSED DOSE:  It is important to get each dose of this medication||
2599|169|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2599|170|D|right away for a new dosing schedule.||
2599|171|B|||
2599|172|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2599|173|R|medication in the original carton to protect from light. This||
2599|174|R|medication may also be stored at room temperature if needed. If||
2599|175|R|the medication is stored at room temperature, different brands of||
2599|176|R|this medication have different storage needs. Check the product||
2599|177|R|package for instructions on how to store your brand, or ask your||
2599|178|R|pharmacist. Keep all medications away from children and pets.||
2599|179|R|   Do not flush medications down the toilet or pour them into a||
2599|180|R|drain unless instructed to do so. Properly discard this product||
2599|181|R|when it is expired or no longer needed. Consult your pharmacist||
2599|182|R|or local waste disposal company.||
2599|183|B|||
2599|184|M|MEDICAL ALERT:  Your condition can cause complications in a||
2599|185|M|medical emergency. For information about enrolling in MedicAlert,||
2599|186|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2599|187|B|||
2599|188|A|Information last revised August 2025.||
2599|189|A|Copyright(c) 2025 First Databank, Inc.||
2599|190|B|||
2600|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2600|002|Z|does NOT have all possible information about this product. This||
2600|003|Z|information does not assure that this product is safe, effective,||
2600|004|Z|or appropriate for you. This information is not individual||
2600|005|Z|medical advice and does not substitute for the advice of your||
2600|006|Z|health care professional. Always ask your health care||
2600|007|Z|professional for complete information about this product and your||
2600|008|Z|specific health needs.||
2600|009|B|||
2600|010|T|VADADUSTAT - ORAL||
2600|011|F|(VAD-a-DOO-stat)||
2600|012|B|||
2600|013|C|COMMON BRAND NAME(S): Vafseo||
2600|014|B|||
2600|015|W|WARNING:  Vadadustat may cause serious (sometimes fatal) problems||
2600|016|W|from blood clots (such as heart attack, stroke, blood clots in||
2600|017|W|the lungs or legs). You may be at increased risk if you have a||
2600|018|W|history of blood clots or heart/blood vessel disease. The lowest||
2600|019|W|effective dose of this medication should be used. It is very||
2600|020|W|important to keep all lab appointments since your doctor will||
2600|021|W|need to carefully monitor your red blood cell count and||
2600|022|W|hemoglobin level. Get medical help right away if any of these||
2600|023|W|side effects occur: shortness of breath/rapid breathing,||
2600|024|W|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
2600|025|W|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
2600|026|W|sudden/severe headaches, trouble speaking, weakness on one side||
2600|027|W|of the body, or sudden vision changes.||
2600|028|B|||
2600|029|U|USES:  This medication is used to treat anemia (low red blood||
2600|030|U|cell count) in people with long-term serious kidney disease||
2600|031|U|(chronic kidney disease) on kidney dialysis. Vadadustat works by||
2600|032|U|increasing a natural substance in your body (erythropoietin) that||
2600|033|U|signals the bone marrow to make more red blood cells.||
2600|034|B|||
2600|035|H|HOW TO USE:  Read the Medication Guide provided by your||
2600|036|H|pharmacist before you start taking vadadustat and each time you||
2600|037|H|get a refill. If you have any questions, ask your doctor or||
2600|038|H|pharmacist.||
2600|039|H|   Take this medication by mouth with or without food as directed||
2600|040|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2600|041|H|not cut, crush, or chew the tablets.||
2600|042|H|   The dosage is based on your medical condition, response to||
2600|043|H|treatment, and lab tests.||
2600|044|H|   Use this medication regularly to get the most benefit from it.||
2600|045|H|To help you remember, take it at the same time each day.||
2600|046|H|   Do not increase your dose or use this drug more often or for||
2600|047|H|longer than prescribed. Your condition will not improve any||
2600|048|H|faster, and your risk of side effects will increase.||
2600|049|H|   Take this medication at least 1 hour before or 2 hours after||
2600|050|H|taking phosphate binders (such as calcium acetate, sevelamer||
2600|051|H|carbonate). If you are also taking products containing iron (such||
2600|052|H|as iron supplements, ferric citrate, sucroferric oxyhydroxide),||
2600|053|H|take this medication at least 1 hour before these products. These||
2600|054|H|medications bind to vadadustat, making it work less well.||
2600|055|H|   Tell your doctor if your symptoms do not get better or if they||
2600|056|H|get worse.||
2600|057|B|||
2600|058|S|SIDE EFFECTS:  See also Warning section.||
2600|059|S|   Diarrhea may occur. If this effect lasts or gets worse, tell||
2600|060|S|your doctor or pharmacist promptly.||
2600|061|S|   Remember that this medication has been prescribed because your||
2600|062|S|doctor has judged that the benefit to you is greater than the||
2600|063|S|risk of side effects. Many people using this medication do not||
2600|064|S|have serious side effects.||
2600|065|S|   This medication may raise your blood pressure. Check your||
2600|066|S|blood pressure regularly and tell your doctor if the results are||
2600|067|S|high. Your doctor may control your blood pressure with||
2600|068|S|medication.||
2600|069|S|   Tell your doctor right away if you have any serious side||
2600|070|S|effects, including: signs of liver disease (such as||
2600|071|S|nausea/vomiting that doesn't stop, loss of appetite,||
2600|072|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2600|073|S|   Get medical help right away if you have any very serious side||
2600|074|S|effects, including: seizures, symptoms of stomach/intestinal||
2600|075|S|bleeding (such as black/bloody stools, vomit that contains blood||
2600|076|S|or looks like coffee grounds, dizziness).||
2600|077|S|   A very serious allergic reaction to this drug is rare.||
2600|078|S|However, get medical help right away if you notice any symptoms||
2600|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2600|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2600|081|S|breathing.||
2600|082|S|   This is not a complete list of possible side effects. If you||
2600|083|S|notice other effects not listed above, contact your doctor or||
2600|084|S|pharmacist.||
2600|085|S|   In the US -||
2600|086|S|   Call your doctor for medical advice about side effects. You||
2600|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2600|088|S|www.fda.gov/medwatch.||
2600|089|S|   In Canada - Call your doctor for medical advice about side||
2600|090|S|effects. You may report side effects to Health Canada at||
2600|091|S|1-866-234-2345.||
2600|092|B|||
2600|093|P|PRECAUTIONS:  See also Warning section.||
2600|094|P|   Before taking vadadustat, tell your doctor or pharmacist if||
2600|095|P|you are allergic to it; or if you have any other allergies. This||
2600|096|P|product may contain inactive ingredients, which can cause||
2600|097|P|allergic reactions or other problems. Talk to your pharmacist for||
2600|098|P|more details.||
2600|099|P|   Before using this medication, tell your doctor or pharmacist||
2600|100|P|your medical history, especially of: alcohol use, cancer, high||
2600|101|P|blood pressure, liver disease, seizure, smoking,||
2600|102|P|stomach/intestinal problems (such as bleeding, ulcers).||
2600|103|P|   Before having surgery, tell your doctor or dentist about all||
2600|104|P|the products you use (including prescription drugs,||
2600|105|P|nonprescription drugs, and herbal products).||
2600|106|P|   During pregnancy, this medication should be used only when||
2600|107|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2600|108|P|benefits with your doctor.||
2600|109|P|   It is unknown if this medication passes into breast milk.||
2600|110|P|Because of the possible risk to the infant, breastfeeding is not||
2600|111|P|recommended while using this medication and for 2 days after the||
2600|112|P|last dose. Consult your doctor before breastfeeding.||
2600|113|B|||
2600|114|I|DRUG INTERACTIONS:  See also How to Use section.||
2600|115|I|   Drug interactions may change how your medications work or||
2600|116|I|increase your risk for serious side effects. This document does||
2600|117|I|not contain all possible drug interactions. Keep a list of all||
2600|118|I|the products you use (including prescription/nonprescription||
2600|119|I|drugs and herbal products) and share it with your doctor and||
2600|120|I|pharmacist. Do not start, stop, or change the dosage of any||
2600|121|I|medicines without your doctor's approval.||
2600|122|I|   This medication can slow down the removal of other medications||
2600|123|I|from your body, which may affect how they work. Examples of||
2600|124|I|affected drugs include elagolix, elbasvir/grazoprevir, ketorolac||
2600|125|I|among others.||
2600|126|B|||
2600|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2600|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2600|129|O|poison control center right away. US residents can call||
2600|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2600|131|B|||
2600|132|N|NOTES:  Do not share this medication with others.||
2600|133|N|   Lab and/or medical tests (such as complete blood count, liver||
2600|134|N|function, blood pressure) should be done before you start taking||
2600|135|N|this medication and while you are taking it. Keep all medical and||
2600|136|N|lab appointments. Consult your doctor for more details.||
2600|137|N|   Blood tests for your iron levels will also be done and you may||
2600|138|N|be prescribed iron supplements. Your doctor may recommend that||
2600|139|N|you eat a well-balanced diet rich in iron sources (such as||
2600|140|N|raisins, figs, meat, eggs, vegetables, iron-fortified cereals).||
2600|141|N|Follow your doctor's instructions and dietary recommendations.||
2600|142|B|||
2600|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2600|144|D|remember. If you don't remember until the next day, skip the||
2600|145|D|missed dose. Take your next dose at the regular time. Do not||
2600|146|D|double the dose to catch up.||
2600|147|B|||
2600|148|R|STORAGE:  Store at room temperature away from light and moisture.||
2600|149|R|Do not store in the bathroom. Keep all medications away from||
2600|150|R|children and pets.||
2600|151|R|   Do not flush medications down the toilet or pour them into a||
2600|152|R|drain unless instructed to do so. Properly discard this product||
2600|153|R|when it is expired or no longer needed. Consult your pharmacist||
2600|154|R|or local waste disposal company.||
2600|155|B|||
2600|156|A|Information last revised October 2024.||
2600|157|A|Copyright(c) 2025 First Databank, Inc.||
2600|158|B|||
2601|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2601|002|Z|does NOT have all possible information about this product. This||
2601|003|Z|information does not assure that this product is safe, effective,||
2601|004|Z|or appropriate for you. This information is not individual||
2601|005|Z|medical advice and does not substitute for the advice of your||
2601|006|Z|health care professional. Always ask your health care||
2601|007|Z|professional for complete information about this product and your||
2601|008|Z|specific health needs.||
2601|009|B|||
2601|010|T|VIGABATRIN SOLUTION - ORAL||
2601|011|F|(vye-GA-ba-trin)||
2601|012|B|||
2601|013|C|COMMON BRAND NAME(S): Vigafyde||
2601|014|B|||
2601|015|W|WARNING:  Serious vision problems may occur while taking this||
2601|016|W|medication and may be permanent even after your child stops||
2601|017|W|taking the medication. To prevent vision problems from getting||
2601|018|W|worse, the doctor must find any eye problems as early as||
2601|019|W|possible. Also, tell the doctor if your child has a history of||
2601|020|W|vision problems. It is very important that your child has an eye||
2601|021|W|exam before or within 4 weeks of starting this medication, then||
2601|022|W|every 3 months after that while taking this medication. Your||
2601|023|W|child should also have an eye exam 3 to 6 months after stopping||
2601|024|W|this medication. Follow the doctor's directions carefully and||
2601|025|W|keep all medical/eye/lab appointments. Tell the doctor right away||
2601|026|W|if your child is acting differently than normal or if you notice||
2601|027|W|any changes in vision (such as loss of vision, sensitivity to||
2601|028|W|light, eye pain).||
2601|029|W|   To receive vigabatrin in the United States, you must||
2601|030|W|understand, agree to, and carefully follow the requirements of||
2601|031|W|the REMS Program for this medication. If you live in Canada or||
2601|032|W|any other country, consult your doctor and pharmacist for your||
2601|033|W|country's regulations.||
2601|034|B|||
2601|035|U|USES:  This medication is used to treat a certain type of seizure||
2601|036|U|in children (infantile spasms). Vigabatrin is an anticonvulsant.||
2601|037|U|It is thought to work by stopping the breakdown of a natural||
2601|038|U|calming substance (GABA) in the brain.||
2601|039|B|||
2601|040|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2601|041|H|sheet provided by the pharmacist before your child starts taking||
2601|042|H|vigabatrin and each time you get a refill. If there are any||
2601|043|H|questions, ask the doctor or pharmacist.||
2601|044|H|   Give this medication by mouth with or without food as directed||
2601|045|H|by the doctor, usually twice daily. Do not mix with water or||
2601|046|H|other liquids when measuring the dose. Carefully measure the dose||
2601|047|H|using a special measuring device/spoon. Do not use a household||
2601|048|H|spoon because your child may not get the correct dose. The dosage||
2601|049|H|is based on your child's medical condition, weight, and response||
2601|050|H|to treatment.||
2601|051|H|   This medication may also be given through a tube into the||
2601|052|H|stomach (gastric tube). If you are giving this medication through||
2601|053|H|a gastric tube, ask your health care professional for detailed||
2601|054|H|instructions on how to give it.||
2601|055|H|   To reduce your child's risk of side effects, the doctor may||
2601|056|H|direct your child to start this medication at a low dose and||
2601|057|H|gradually increase the dose. Follow the doctor's instructions||
2601|058|H|carefully.||
2601|059|H|   Give this medication regularly to get the most benefit from||
2601|060|H|it. To help remember, give it at the same times each day.||
2601|061|H|   Do not increase your child's dose or use this drug more often||
2601|062|H|or for longer than prescribed. The condition will not improve any||
2601|063|H|faster, and your child's risk of side effects will increase.||
2601|064|H|   Do not stop giving this medication without consulting the||
2601|065|H|doctor. Some conditions may become worse when this drug is||
2601|066|H|suddenly stopped. The dose may need to be gradually decreased.||
2601|067|H|   Tell the doctor if your child's seizures get worse or do not||
2601|068|H|get better within 2 to 4 weeks.||
2601|069|B|||
2601|070|S|SIDE EFFECTS:  See also Warning section.||
2601|071|S|   Drowsiness, difficulty feeding, or restlessness may occur.||
2601|072|S|Nausea, vomiting, stomach upset, diarrhea, or weight gain may||
2601|073|S|also occur. If any of these effects last or get worse, tell the||
2601|074|S|doctor or pharmacist promptly.||
2601|075|S|   Remember that this medication has been prescribed because the||
2601|076|S|doctor has judged that the benefit to your child is greater than||
2601|077|S|the risk of side effects. Many people using this medication do||
2601|078|S|not have serious side effects.||
2601|079|S|   In adults, this medication may cause low red blood cell count||
2601|080|S|(anemia) or swelling. Tell the doctor right away if you notice||
2601|081|S|rapid breathing, pale skin, fast heartbeat, or swelling of the||
2601|082|S|ankles/feet in your child.||
2601|083|S|   In adults, a small number of people who take anticonvulsants||
2601|084|S|for any condition (such as seizure, bipolar disorder, pain) may||
2601|085|S|experience depression, suicidal thoughts/attempts, or other||
2601|086|S|mental/mood problems. Talk to your doctor for more details.||
2601|087|S|   A very serious allergic reaction to this drug is rare.||
2601|088|S|However, get medical help right away if you notice any symptoms||
2601|089|S|of a serious allergic reaction, including: rash, itching/swelling||
2601|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2601|091|S|breathing.||
2601|092|S|   This is not a complete list of possible side effects. If you||
2601|093|S|notice other effects not listed above, contact the doctor or||
2601|094|S|pharmacist.||
2601|095|S|   In the US -||
2601|096|S|   Call the doctor for medical advice about side effects. You may||
2601|097|S|report side effects to FDA at 1-800-FDA-1088 or at||
2601|098|S|www.fda.gov/medwatch.||
2601|099|S|   In Canada - Call the doctor for medical advice about side||
2601|100|S|effects. You may report side effects to Health Canada at||
2601|101|S|1-866-234-2345.||
2601|102|B|||
2601|103|P|PRECAUTIONS:  Before giving vigabatrin, tell the doctor or||
2601|104|P|pharmacist if your child is allergic to it; or if they have any||
2601|105|P|other allergies. This product may contain inactive ingredients,||
2601|106|P|which can cause allergic reactions or other problems. Talk to the||
2601|107|P|pharmacist for more details.||
2601|108|P|   Before using this medication, tell the doctor or pharmacist||
2601|109|P|your child's medical history, especially of: eye problems (such||
2601|110|P|as visual field defect, glaucoma, macular degeneration, optic||
2601|111|P|nerve problem), kidney disease.||
2601|112|P|   MRI tests of the brain in children have shown changes after||
2601|113|P|they are given vigabatrin. It is not known if these changes are||
2601|114|P|harmful. Consult the doctor for more details. If your child is||
2601|115|P|going to have an MRI test, tell testing personnel that your child||
2601|116|P|is using this medication.||
2601|117|P|   Before having surgery, tell the doctor or dentist about all||
2601|118|P|the products your child uses (including prescription drugs,||
2601|119|P|nonprescription drugs, and herbal products).||
2601|120|P|   This medication is not usually used by adults. It is unlikely||
2601|121|P|to be used during pregnancy or breastfeeding. Consult the doctor||
2601|122|P|if you have any questions about this medication.||
2601|123|B|||
2601|124|I|DRUG INTERACTIONS:  Drug interactions may change how your child's||
2601|125|I|medications work or increase your child's risk for serious side||
2601|126|I|effects. This document does not contain all possible drug||
2601|127|I|interactions. Keep a list of all the products your child uses||
2601|128|I|(including prescription/nonprescription drugs and herbal||
2601|129|I|products) and share it with the doctor and pharmacist. Do not||
2601|130|I|start, stop, or change the dosage of any medicines without the||
2601|131|I|doctor's approval.||
2601|132|I|   Some products that may interact with this drug are: drugs that||
2601|133|I|can harm the eye (retinotoxic drugs such as chloroquine,||
2601|134|I|hydroxychloroquine, phenothiazines including thioridazine),||
2601|135|I|orlistat.||
2601|136|I|   Tell the doctor or pharmacist if your child is taking other||
2601|137|I|products that cause drowsiness such as opioid pain or cough||
2601|138|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2601|139|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2601|140|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2601|141|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2601|142|I|diphenhydramine).||
2601|143|I|   Check the labels on all your child's medicines (such as||
2601|144|I|allergy or cough-and-cold products) because they may contain||
2601|145|I|ingredients that cause drowsiness. Ask the pharmacist about using||
2601|146|I|those products safely.||
2601|147|I|   This medication may interfere with certain lab tests (such as||
2601|148|I|liver function tests), possibly causing false test results. Make||
2601|149|I|sure lab personnel and all the doctors know your child uses this||
2601|150|I|drug.||
2601|151|B|||
2601|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2601|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2601|154|O|poison control center right away. US residents can call||
2601|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2601|156|O|Symptoms of overdose may include: slow/shallow breathing, loss of||
2601|157|O|consciousness.||
2601|158|B|||
2601|159|N|NOTES:  Do not share this medication with others.||
2601|160|N|   Lab and/or medical tests (such as eye exams, kidney function,||
2601|161|N|complete blood count) should be done while your child is taking||
2601|162|N|this medication. Keep all medical and lab appointments. Consult||
2601|163|N|the doctor for more details.||
2601|164|B|||
2601|165|D|MISSED DOSE:  If your child misses a dose, give it as soon as you||
2601|166|D|remember. If it is near the time of the next dose, skip the||
2601|167|D|missed dose. Give the next dose at the regular time. Do not||
2601|168|D|double the dose to catch up.||
2601|169|B|||
2601|170|R|STORAGE:  Store unopened bottle at room temperature. Once the||
2601|171|R|bottle is opened, this medication may be stored at room||
2601|172|R|temperature or in the refrigerator and expires after 90 days.||
2601|173|R|Keep all medications away from children and pets.||
2601|174|R|   Do not flush medications down the toilet or pour them into a||
2601|175|R|drain unless instructed to do so. Properly discard this product||
2601|176|R|when it is expired or no longer needed. Consult the pharmacist or||
2601|177|R|local waste disposal company.||
2601|178|B|||
2601|179|M|MEDICAL ALERT:  Your child's condition can cause complications in||
2601|180|M|a medical emergency. For information about enrolling in||
2601|181|M|MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2601|182|B|||
2601|183|A|Information last revised September 2025.||
2601|184|A|Copyright(c) 2025 First Databank, Inc.||
2601|185|B|||
2602|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2602|002|Z|does NOT have all possible information about this product. This||
2602|003|Z|information does not assure that this product is safe, effective,||
2602|004|Z|or appropriate for you. This information is not individual||
2602|005|Z|medical advice and does not substitute for the advice of your||
2602|006|Z|health care professional. Always ask your health care||
2602|007|Z|professional for complete information about this product and your||
2602|008|Z|specific health needs.||
2602|009|B|||
2602|010|T|AFAMITRESGENE AUTOLEUCEL - INJECTION||
2602|011|B|||
2602|012|C|COMMON BRAND NAME(S): Tecelra||
2602|013|B|||
2602|014|W|WARNING:  This product may cause a serious (even fatal) reaction||
2602|015|W|called cytokine release syndrome-CRS. Careful monitoring and||
2602|016|W|prompt treatment may decrease your risk. Before treatment with||
2602|017|W|this product, tell your doctor your medical history, especially||
2602|018|W|of any current/recent infection. Tell your doctor right away if||
2602|019|W|you have any symptoms of CRS such as fever, chills/shaking||
2602|020|W|chills, fast/irregular heartbeat, shortness of breath, severe||
2602|021|W|nausea/vomiting/diarrhea, severe headache, low blood pressure, or||
2602|022|W|dizziness/lightheadedness.||
2602|023|B|||
2602|024|U|USES:  Afamitresgene autoleucel is used to treat a certain type||
2602|025|U|of cancer (synovial sarcoma) that has not gotten better or that||
2602|026|U|has come back after other kinds of treatment. This type of||
2602|027|U|treatment is known as gene therapy. Afamitresgene autoleucel is||
2602|028|U|made from your own white blood cells and is given only to you.||
2602|029|U|The white blood cells have been changed to have a specific||
2602|030|U|protein that helps your body slow or stop the growth of certain||
2602|031|U|cancer cells.||
2602|032|B|||
2602|033|H|HOW TO USE:  Read the Medication Guide provided by your||
2602|034|H|healthcare professional before you start using this product. If||
2602|035|H|you have any questions, ask your healthcare professionals.||
2602|036|H|   Your doctor may give you 4 days of chemotherapy before||
2602|037|H|treatment with this product to prepare your body.||
2602|038|H|   This product is given by slow injection into a vein as||
2602|039|H|directed by your doctor, usually over less than 60 minutes. To||
2602|040|H|decrease the risk of side effects, your doctor may also give you||
2602|041|H|other medications (such as acetaminophen, diphenhydramine) before||
2602|042|H|injecting afamitresgene autoleucel.||
2602|043|H|   Your doctor will check you daily for at least 7 days after||
2602|044|H|your treatment to see how well it works and help you manage any||
2602|045|H|side effects. You should plan to stay for at least 4 weeks near||
2602|046|H|the place of your treatment (for example, within 2 hours' drive).||
2602|047|B|||
2602|048|S|SIDE EFFECTS:  See also Warning section.||
2602|049|S|   Nausea, vomiting, constipation, or tiredness may occur. If any||
2602|050|S|of these effects last or get worse, tell your doctor or||
2602|051|S|pharmacist promptly.||
2602|052|S|   People using this medication may have serious side effects.||
2602|053|S|However, you have been prescribed this drug because your doctor||
2602|054|S|has judged that the benefit to you is greater than the risk of||
2602|055|S|side effects. Careful monitoring by your doctor may decrease your||
2602|056|S|risk.||
2602|057|S|   Serious nerve problems can occur after treatment with||
2602|058|S|afamitresgene autoleucel. Tell your doctor right away if you have||
2602|059|S|drowsiness, seizures, mental/mood changes (such as confusion,||
2602|060|S|anxiety, memory loss), or trouble with reading, writing,||
2602|061|S|speaking, or understanding.||
2602|062|S|   Although afamitresgene autoleucel is used to treat cancer, it||
2602|063|S|may rarely increase your risk of developing other cancers. Also,||
2602|064|S|this product may cause a severe decrease in your blood cells,||
2602|065|S|which lowers your ability to fight infections and increases the||
2602|066|S|risk of anemia/bleeding problems. You may be more likely to get a||
2602|067|S|serious (rarely fatal) infection and any infection you have may||
2602|068|S|get worse. Tell your doctor right away if you develop unusual||
2602|069|S|growths or lumps, swollen lymph nodes, signs of infection (such||
2602|070|S|as sore throat that doesn't go away, fever, chills), easy or||
2602|071|S|unusual bruising/bleeding, or unusual tiredness.||
2602|072|S|   A very serious allergic reaction to this drug is rare.||
2602|073|S|However, get medical help right away if you notice any symptoms||
2602|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2602|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2602|076|S|breathing.||
2602|077|S|   This is not a complete list of possible side effects. If you||
2602|078|S|notice other effects not listed above, contact your doctor or||
2602|079|S|pharmacist.||
2602|080|S|   In the US -||
2602|081|S|   Call your doctor for medical advice about side effects. You||
2602|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2602|083|S|www.fda.gov/medwatch.||
2602|084|S|   In Canada - Call your doctor for medical advice about side||
2602|085|S|effects. You may report side effects to Health Canada at||
2602|086|S|1-866-234-2345.||
2602|087|B|||
2602|088|P|PRECAUTIONS:  Before receiving afamitresgene autoleucel, tell||
2602|089|P|your doctor or pharmacist if you have any allergies. This product||
2602|090|P|may contain inactive ingredients, which can cause allergic||
2602|091|P|reactions or other problems. Talk to your pharmacist for more||
2602|092|P|details.||
2602|093|P|   Before using this product, tell your doctor or pharmacist your||
2602|094|P|medical history, especially of: heart problems, kidney problems,||
2602|095|P|liver problems, lung/breathing problems, nerve problems (such as||
2602|096|P|memory loss, seizures), past/current/recent infection.||
2602|097|P|   This product can make you more likely to get infections or may||
2602|098|P|make current infections worse. Stay away from anyone who has an||
2602|099|P|infection that may easily spread (such as chickenpox, COVID-19,||
2602|100|P|measles, flu). Talk to your doctor if you have been exposed to an||
2602|101|P|infection or for more details.||
2602|102|P|   Tell your health care professional that you are using||
2602|103|P|afamitresgene autoleucel before having any||
2602|104|P|immunizations/vaccinations. Avoid contact with people who have||
2602|105|P|recently received live vaccines (such as flu vaccine inhaled||
2602|106|P|through the nose).||
2602|107|P|   To lower the chance of getting cut, bruised, or injured, use||
2602|108|P|caution with sharp objects like razors and nail cutters, and||
2602|109|P|avoid activities such as contact sports.||
2602|110|P|   This drug may make you drowsy or dizzy, affect your||
2602|111|P|coordination, or make it harder for you to think clearly. Alcohol||
2602|112|P|or marijuana (cannabis) can worsen these effects. Do not drive,||
2602|113|P|use machinery, or do anything that needs alertness until you can||
2602|114|P|do it safely (at least 4 weeks after receiving treatment is||
2602|115|P|recommended by the manufacturer). Limit alcoholic beverages. Talk||
2602|116|P|to your doctor if you are using marijuana (cannabis).||
2602|117|P|   Before having surgery, tell your doctor or dentist about all||
2602|118|P|the products you use (including prescription drugs,||
2602|119|P|nonprescription drugs, and herbal products).||
2602|120|P|   Tell your doctor if you are pregnant or plan to become||
2602|121|P|pregnant. You should not become pregnant while using this||
2602|122|P|product. Afamitresgene autoleucel may harm an unborn baby. Your||
2602|123|P|doctor should order a pregnancy test before you start this||
2602|124|P|product. If you become pregnant, talk to your doctor right away||
2602|125|P|about the risks and benefits of this product.||
2602|126|P|   It is unknown if this product passes into breast milk. Consult||
2602|127|P|your doctor before breastfeeding.||
2602|128|B|||
2602|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2602|130|I|medications work or increase your risk for serious side effects.||
2602|131|I|This document does not contain all possible drug interactions.||
2602|132|I|Keep a list of all the products you use (including||
2602|133|I|prescription/nonprescription drugs and herbal products) and share||
2602|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
2602|135|I|the dosage of any medicines without your doctor's approval.||
2602|136|I|   This product may interfere with certain lab tests (such as||
2602|137|I|some HIV tests), possibly causing false test results. Make sure||
2602|138|I|lab personnel and all your doctors know you use this drug.||
2602|139|B|||
2602|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2602|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2602|142|O|poison control center right away. US residents can call||
2602|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2602|144|B|||
2602|145|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
2602|146|N|should be done before and after you receive this product. Keep||
2602|147|N|all medical and lab appointments.||
2602|148|N|   After receiving this treatment, do not donate blood, organs,||
2602|149|N|tissues, or cells.||
2602|150|B|||
2602|151|D|MISSED DOSE:  Not applicable.||
2602|152|B|||
2602|153|R|STORAGE:  Not applicable. This product is given in a hospital or||
2602|154|R|clinic and will not be stored at home.||
2602|155|B|||
2602|156|M|MEDICAL ALERT:  Your condition can cause complications in a||
2602|157|M|medical emergency. For information about enrolling in MedicAlert,||
2602|158|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2602|159|B|||
2602|160|A|Information last revised May 2025.||
2602|161|A|Copyright(c) 2025 First Databank, Inc.||
2602|162|B|||
2603|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2603|002|Z|does NOT have all possible information about this product. This||
2603|003|Z|information does not assure that this product is safe, effective,||
2603|004|Z|or appropriate for you. This information is not individual||
2603|005|Z|medical advice and does not substitute for the advice of your||
2603|006|Z|health care professional. Always ask your health care||
2603|007|Z|professional for complete information about this product and your||
2603|008|Z|specific health needs.||
2603|009|B|||
2603|010|T|VORASIDENIB - ORAL||
2603|011|F|(VOR-a-SID-e-nib)||
2603|012|B|||
2603|013|C|COMMON BRAND NAME(S): Voranigo||
2603|014|B|||
2603|015|U|USES:  This medication is used to treat certain types of brain||
2603|016|U|tumors (astrocytoma, oligodendroglioma). Vorasidenib works by||
2603|017|U|stopping or slowing the growth of tumor cells.||
2603|018|B|||
2603|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2603|020|H|from your pharmacist before you start taking vorasidenib and each||
2603|021|H|time you get a refill. If you have any questions, ask your doctor||
2603|022|H|or pharmacist.||
2603|023|H|   Take this medication by mouth as directed by your doctor,||
2603|024|H|usually once daily. Swallow the tablets whole with water. Do not||
2603|025|H|split, crush, or chew the tablets. Some brands should be taken on||
2603|026|H|an empty stomach, while other brands may be taken with or without||
2603|027|H|food. If you are taking this medication on an empty stomach, do||
2603|028|H|not eat food at least 2 hours before and 1 hour after taking this||
2603|029|H|medication. If you have any questions, ask your doctor or||
2603|030|H|pharmacist about your brand.||
2603|031|H|   The dosage is based on your medical condition and response to||
2603|032|H|treatment. Children's dosage is also based on weight.||
2603|033|H|   Use this medication regularly to get the most benefit from it.||
2603|034|H|To help you remember, take it at the same time each day.||
2603|035|H|   Do not increase your dose or use this drug more often or for||
2603|036|H|longer than prescribed. Your condition will not improve any||
2603|037|H|faster, and your risk of serious side effects will increase.||
2603|038|H|   If you vomit after taking a dose, do not take another dose.||
2603|039|H|Take your next dose at the regular time. Do not double the dose||
2603|040|H|to catch up.||
2603|041|B|||
2603|042|S|SIDE EFFECTS:  Tiredness, diarrhea, or loss of appetite may||
2603|043|S|occur. If any of these effects last or get worse, tell your||
2603|044|S|doctor or pharmacist promptly.||
2603|045|S|   Remember that this medication has been prescribed because your||
2603|046|S|doctor has judged that the benefit to you is greater than the||
2603|047|S|risk of side effects. Many people using this medication do not||
2603|048|S|have serious side effects.||
2603|049|S|   Tell your doctor right away if you have any serious side||
2603|050|S|effects, including: signs of liver problems (such as||
2603|051|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
2603|052|S|yellowing eyes/skin, dark urine).||
2603|053|S|   A very serious allergic reaction to this drug is rare.||
2603|054|S|However, get medical help right away if you notice any symptoms||
2603|055|S|of a serious allergic reaction, including: rash, itching/swelling||
2603|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2603|057|S|breathing.||
2603|058|S|   This is not a complete list of possible side effects. If you||
2603|059|S|notice other effects not listed above, contact your doctor or||
2603|060|S|pharmacist.||
2603|061|S|   In the US -||
2603|062|S|   Call your doctor for medical advice about side effects. You||
2603|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2603|064|S|www.fda.gov/medwatch.||
2603|065|S|   In Canada - Call your doctor for medical advice about side||
2603|066|S|effects. You may report side effects to Health Canada at||
2603|067|S|1-866-234-2345.||
2603|068|B|||
2603|069|P|PRECAUTIONS:  Before taking vorasidenib, tell your doctor or||
2603|070|P|pharmacist if you are allergic to it; or if you have any other||
2603|071|P|allergies. This product may contain inactive ingredients, which||
2603|072|P|can cause allergic reactions or other problems. Talk to your||
2603|073|P|pharmacist for more details.||
2603|074|P|   Before taking this medication, tell your doctor or pharmacist||
2603|075|P|your medical history, especially of: liver problems.||
2603|076|P|   Before having surgery, tell your doctor or dentist about all||
2603|077|P|the products you use (including prescription drugs,||
2603|078|P|nonprescription drugs, and herbal products).||
2603|079|P|   Tell your doctor if you are pregnant or plan to become||
2603|080|P|pregnant. You should not become pregnant while taking||
2603|081|P|vorasidenib. Vorasidenib may harm an unborn baby. Your doctor||
2603|082|P|should order a pregnancy test before you start this medication.||
2603|083|P|Men and women using this medication should ask about reliable||
2603|084|P|forms of non-hormonal birth control (such as condoms, diaphragm||
2603|085|P|with spermicide) during treatment and for 3 months after the last||
2603|086|P|dose. If you or your partner becomes pregnant, talk to your||
2603|087|P|doctor right away about the risks and benefits of this||
2603|088|P|medication.||
2603|089|P|   It is unknown if this drug passes into breast milk. Because of||
2603|090|P|the possible risk to the infant, breastfeeding is not recommended||
2603|091|P|while using this drug and for 2 months after the last dose.||
2603|092|P|Consult your doctor before breastfeeding.||
2603|093|B|||
2603|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2603|095|I|medications work or increase your risk for serious side effects.||
2603|096|I|This document does not contain all possible drug interactions.||
2603|097|I|Keep a list of all the products you use (including||
2603|098|I|prescription/nonprescription drugs and herbal products) and share||
2603|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2603|100|I|the dosage of any medicines without your doctor's approval.||
2603|101|I|   Other medications can affect the removal of vorasidenib from||
2603|102|I|your body, which may affect how vorasidenib works. Examples||
2603|103|I|include ciprofloxacin, enasidenib, fluvoxamine, leflunomide,||
2603|104|I|phenytoin, rifampin, ritonavir, teriflunomide, among others.||
2603|105|I|   This medication may decrease the effectiveness of hormonal||
2603|106|I|birth control such as pills, patch, or ring. This could cause||
2603|107|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2603|108|I|use reliable backup birth control methods while using this||
2603|109|I|medication. Also tell your doctor if you have any new spotting or||
2603|110|I|breakthrough bleeding, because these may be signs that your birth||
2603|111|I|control is not working well.||
2603|112|I|   Cigarette smoking decreases blood levels of this medication.||
2603|113|I|Tell your doctor if you smoke or if you have recently stopped||
2603|114|I|smoking.||
2603|115|B|||
2603|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2603|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2603|118|O|poison control center right away. US residents can call||
2603|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2603|120|B|||
2603|121|N|NOTES:  Do not share this medication with others.||
2603|122|N|   Lab and/or medical tests (such as liver function) should be||
2603|123|N|done before you start taking this medication and while you are||
2603|124|N|taking it. Keep all medical and lab appointments.||
2603|125|B|||
2603|126|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2603|127|D|remember. If it is more than 6 hours after the missed dose, skip||
2603|128|D|the missed dose. Take your next dose at the regular time. Do not||
2603|129|D|double the dose to catch up.||
2603|130|B|||
2603|131|R|STORAGE:  Store at room temperature away from light and moisture.||
2603|132|R|Do not store in the bathroom. Keep the drying agent (desiccant)||
2603|133|R|in the bottle. Tightly close the bottle when not in use. Keep all||
2603|134|R|medications away from children and pets.||
2603|135|R|   Do not flush medications down the toilet or pour them into a||
2603|136|R|drain unless instructed to do so. Properly discard this product||
2603|137|R|when it is expired or no longer needed. Consult your pharmacist||
2603|138|R|or local waste disposal company.||
2603|139|B|||
2603|140|A|Information last revised December 2024.||
2603|141|A|Copyright(c) 2025 First Databank, Inc.||
2603|142|B|||
2604|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2604|002|Z|does NOT have all possible information about this product. This||
2604|003|Z|information does not assure that this product is safe, effective,||
2604|004|Z|or appropriate for you. This information is not individual||
2604|005|Z|medical advice and does not substitute for the advice of your||
2604|006|Z|health care professional. Always ask your health care||
2604|007|Z|professional for complete information about this product and your||
2604|008|Z|specific health needs.||
2604|009|B|||
2604|010|T|NEMOLIZUMAB - INJECTION||
2604|011|F|(NEE-moe-LIZ-ue-mab)||
2604|012|B|||
2604|013|C|COMMON BRAND NAME(S): Nemluvio||
2604|014|B|||
2604|015|U|USES:  This medication is used to treat certain skin conditions||
2604|016|U|(prurigo nodularis, atopic dermatitis). Nemolizumab belongs to a||
2604|017|U|class of drugs known as monoclonal antibodies. It works by||
2604|018|U|blocking certain natural proteins in your body (interleukin-31)||
2604|019|U|that may cause swelling, itching, and other skin problems.||
2604|020|B|||
2604|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2604|022|H|Instructions for Use provided by your pharmacist before you start||
2604|023|H|using nemolizumab and each time you get a refill. Ask your health||
2604|024|H|care professional how to prepare and use this medication. If you||
2604|025|H|have any questions, ask your doctor or pharmacist.||
2604|026|H|   Before starting treatment with nemolizumab, you should be up||
2604|027|H|to date with all your vaccinations. Ask your doctor if you need||
2604|028|H|to receive any vaccines before starting nemolizumab.||
2604|029|H|   Inject this medication under the skin as directed by your||
2604|030|H|doctor, usually once every 4 weeks. If you are using this||
2604|031|H|medication for atopic dermatitis, this medication may be given||
2604|032|H|once every 8 weeks after the first 5 doses. The injection is||
2604|033|H|given in the upper arms, thighs, or abdomen (except for a 2-inch||
2604|034|H|area around your belly button). The dosage is based on your||
2604|035|H|weight.||
2604|036|H|   Take the medication out of the refrigerator 30 to 45 minutes||
2604|037|H|before you inject it to allow it to reach room temperature. Do||
2604|038|H|not warm up this medication any other way (for example, do not||
2604|039|H|heat it in the microwave, place it in hot water, or leave it in||
2604|040|H|direct sunlight). Before using, check this product for particles||
2604|041|H|or discoloration. If either is present, do not use the liquid.||
2604|042|H|Before injecting each dose, clean the skin you are going to||
2604|043|H|inject into (the injection site) with rubbing alcohol. Change the||
2604|044|H|injection site each time to lessen injury under the skin. Do not||
2604|045|H|inject into skin that is red, tender, swollen, bruised, damaged,||
2604|046|H|or has scars or stretch marks. To lessen bruising, do not rub the||
2604|047|H|injection site after a shot. Once mixed, discard any unused||
2604|048|H|medication after 4 hours. Learn how to store and discard medical||
2604|049|H|supplies safely.||
2604|050|H|   Use this medication regularly to get the most benefit from it.||
2604|051|H|To help you remember, mark your calendar with a reminder.||
2604|052|H|   Tell your doctor if your condition does not get better or if||
2604|053|H|it gets worse.||
2604|054|B|||
2604|055|S|SIDE EFFECTS:  Headache or joint/muscle pain may occur. If any of||
2604|056|S|these effects last or get worse, tell your doctor or pharmacist||
2604|057|S|promptly.||
2604|058|S|   Remember that this medication has been prescribed because your||
2604|059|S|doctor has judged that the benefit to you is greater than the||
2604|060|S|risk of side effects. Many people using this medication do not||
2604|061|S|have serious side effects.||
2604|062|S|   Tell your doctor right away if you have any serious side||
2604|063|S|effects, including: signs of new or worsening skin condition||
2604|064|S|(such as red bumps, red skin patches).||
2604|065|S|   A very serious allergic reaction to this drug is rare.||
2604|066|S|However, get medical help right away if you notice any symptoms||
2604|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2604|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2604|069|S|breathing.||
2604|070|S|   This is not a complete list of possible side effects. If you||
2604|071|S|notice other effects not listed above, contact your doctor or||
2604|072|S|pharmacist.||
2604|073|S|   In the US -||
2604|074|S|   Call your doctor for medical advice about side effects. You||
2604|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2604|076|S|www.fda.gov/medwatch.||
2604|077|S|   In Canada - Call your doctor for medical advice about side||
2604|078|S|effects. You may report side effects to Health Canada at||
2604|079|S|1-866-234-2345.||
2604|080|B|||
2604|081|P|PRECAUTIONS:  Before using nemolizumab, tell your doctor or||
2604|082|P|pharmacist if you are allergic to it; or if you have any other||
2604|083|P|allergies. This product may contain inactive ingredients, which||
2604|084|P|can cause allergic reactions or other problems. Talk to your||
2604|085|P|pharmacist for more details.||
2604|086|P|   Before using this medication, tell your doctor or pharmacist||
2604|087|P|your medical history.||
2604|088|P|   This drug may affect live vaccines. Tell your health care||
2604|089|P|professional that you are using nemolizumab before having any||
2604|090|P|immunizations/vaccinations.||
2604|091|P|   Before having surgery, tell your doctor or dentist about all||
2604|092|P|the products you use (including prescription drugs,||
2604|093|P|nonprescription drugs, and herbal products).||
2604|094|P|   During pregnancy, this medication should be used only when||
2604|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
2604|096|P|   It is unknown if this medication passes into breast milk.||
2604|097|P|Consult your doctor before breastfeeding.||
2604|098|B|||
2604|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2604|100|I|medications work or increase your risk for serious side effects.||
2604|101|I|This document does not contain all possible drug interactions.||
2604|102|I|Keep a list of all the products you use (including||
2604|103|I|prescription/nonprescription drugs and herbal products) and share||
2604|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
2604|105|I|the dosage of any medicines without your doctor's approval.||
2604|106|B|||
2604|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2604|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2604|109|O|poison control center right away. US residents can call||
2604|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2604|111|B|||
2604|112|N|NOTES:  Do not share this medication with others.||
2604|113|B|||
2604|114|D|MISSED DOSE:  It is important to get each dose of this medication||
2604|115|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2604|116|D|right away for a new dosing schedule.||
2604|117|B|||
2604|118|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2604|119|R|medication in the original carton to protect from light. This||
2604|120|R|medication may also be stored at room temperature if needed. If||
2604|121|R|the medication is stored at room temperature, discard after 90||
2604|122|R|days. Keep all medications away from children and pets.||
2604|123|R|   Do not flush medications down the toilet or pour them into a||
2604|124|R|drain unless instructed to do so. Properly discard this product||
2604|125|R|when it is expired or no longer needed. Consult your pharmacist||
2604|126|R|or local waste disposal company.||
2604|127|B|||
2604|128|A|Information last revised February 2025.||
2604|129|A|Copyright(c) 2025 First Databank, Inc.||
2604|130|B|||
2605|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2605|002|Z|does NOT have all possible information about this product. This||
2605|003|Z|information does not assure that this product is safe, effective,||
2605|004|Z|or appropriate for you. This information is not individual||
2605|005|Z|medical advice and does not substitute for the advice of your||
2605|006|Z|health care professional. Always ask your health care||
2605|007|Z|professional for complete information about this product and your||
2605|008|Z|specific health needs.||
2605|009|B|||
2605|010|T|MARALIXIBAT 9.5 MG/ML SOLUTION - ORAL||
2605|011|F|(MAR-a-LIX-i-bat)||
2605|012|B|||
2605|013|C|COMMON BRAND NAME(S): Livmarli||
2605|014|B|||
2605|015|U|USES:  This medication is used to treat skin itching caused by a||
2605|016|U|certain inherited liver condition (Alagille syndrome-ALGS). In||
2605|017|U|ALGS, a substance that your body normally makes (bilirubin)||
2605|018|U|builds up in the liver and causes jaundice. Maralixibat belongs||
2605|019|U|to a class of drugs known as ileal bile acid transporter||
2605|020|U|inhibitors. It helps to lessen symptoms of jaundice such as||
2605|021|U|itching, yellowing eyes/skin, dark urine, and pale-colored||
2605|022|U|stools.||
2605|023|B|||
2605|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
2605|025|H|Instructions for Use if available from your pharmacist before you||
2605|026|H|start using maralixibat and each time you get a refill. If you||
2605|027|H|have any questions, ask your doctor or pharmacist.||
2605|028|H|   Take this medication by mouth as directed by your doctor,||
2605|029|H|usually once daily 30 minutes before your morning meal. Carefully||
2605|030|H|measure the dose using a special measuring device/spoon. Do not||
2605|031|H|use a household spoon because you may not get the correct dose.||
2605|032|H|The dosage is based on your medical condition, weight, and||
2605|033|H|response to treatment.||
2605|034|H|   To reduce your risk of side effects, your doctor may direct||
2605|035|H|you to start this medication at a low dose and gradually increase||
2605|036|H|your dose. Follow your doctor's instructions carefully.||
2605|037|H|   Use this medication regularly to get the most benefit from it.||
2605|038|H|To help you remember, take it at the same time each day.||
2605|039|H|   Do not increase your dose or use this drug more often or for||
2605|040|H|longer than prescribed. Your condition will not improve any||
2605|041|H|faster, and your risk of side effects will increase.||
2605|042|H|   If you are also taking bile acid-binding resins such as||
2605|043|H|cholestyramine, colesevelam, or colestipol, take this medication||
2605|044|H|at least 4 hours before or at least 4 hours after taking these||
2605|045|H|medications. These medications can bind to maralixibat,||
2605|046|H|preventing your body from fully absorbing the drug.||
2605|047|H|   Tell your doctor if your condition does not get better or if||
2605|048|H|it gets worse.||
2605|049|B|||
2605|050|S|SIDE EFFECTS:  Diarrhea, vomiting, or abdominal pain may occur.||
2605|051|S|If any of these effects last or get worse, tell your doctor or||
2605|052|S|pharmacist promptly.||
2605|053|S|   Remember that this medication has been prescribed because your||
2605|054|S|doctor has judged that the benefit to you is greater than the||
2605|055|S|risk of side effects. Many people using this medication do not||
2605|056|S|have serious side effects.||
2605|057|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2605|058|S|Contact your doctor promptly if you notice any symptoms of||
2605|059|S|dehydration, such as unusual decreased urination, unusual dry||
2605|060|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness.||
2605|061|S|   This medication may lower your fat-soluble vitamin levels, and||
2605|062|S|that may increase your risk for bone fractures and bleeding. Talk||
2605|063|S|to your doctor for more details.||
2605|064|S|   Although this medication is used to treat liver problems, it||
2605|065|S|may sometimes cause liver tests to worsen. Tell your doctor right||
2605|066|S|away if you have symptoms of worsening liver problems such as||
2605|067|S|nausea/vomiting that doesn't stop, loss of appetite, yellowing||
2605|068|S|eyes/skin, or dark urine.||
2605|069|S|   Tell your doctor right away if you have any serious side||
2605|070|S|effects, including: abdominal pain that won't go away,||
2605|071|S|blood/mucus in stools, fever.||
2605|072|S|   A very serious allergic reaction to this drug is rare.||
2605|073|S|However, get medical help right away if you notice any symptoms||
2605|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2605|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2605|076|S|breathing.||
2605|077|S|   This is not a complete list of possible side effects. If you||
2605|078|S|notice other effects not listed above, contact your doctor or||
2605|079|S|pharmacist.||
2605|080|S|   In the US -||
2605|081|S|   Call your doctor for medical advice about side effects. You||
2605|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2605|083|S|www.fda.gov/medwatch.||
2605|084|S|   In Canada - Call your doctor for medical advice about side||
2605|085|S|effects. You may report side effects to Health Canada at||
2605|086|S|1-866-234-2345.||
2605|087|B|||
2605|088|P|PRECAUTIONS:  Before taking maralixibat, tell your doctor or||
2605|089|P|pharmacist if you are allergic to it; or if you have any other||
2605|090|P|allergies. This product may contain inactive ingredients (such as||
2605|091|P|propylene glycol), which can cause allergic reactions or other||
2605|092|P|problems. Talk to your pharmacist for more details.||
2605|093|P|   Before using this medication, tell your doctor or pharmacist||
2605|094|P|your medical history, especially of: other liver problems (such||
2605|095|P|as ascites, encephalopathy).||
2605|096|P|   Before having surgery, tell your doctor or dentist about all||
2605|097|P|the products you use (including prescription drugs,||
2605|098|P|nonprescription drugs, and herbal products).||
2605|099|P|   Children may be more sensitive to the effects of this drug.||
2605|100|P|The propylene glycol in this medication may cause serious side||
2605|101|P|effects in children, especially children under 5 years of age.||
2605|102|P|   During pregnancy, this medication should be used only when||
2605|103|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2605|104|P|benefits with your doctor.||
2605|105|P|   It is unknown if this medication passes into breast milk.||
2605|106|P|Consult your doctor before breastfeeding.||
2605|107|B|||
2605|108|I|DRUG INTERACTIONS:  See also How to Use section.||
2605|109|I|   Drug interactions may change how your medications work or||
2605|110|I|increase your risk for serious side effects. This document does||
2605|111|I|not contain all possible drug interactions. Keep a list of all||
2605|112|I|the products you use (including prescription/nonprescription||
2605|113|I|drugs and herbal products) and share it with your doctor and||
2605|114|I|pharmacist. Do not start, stop, or change the dosage of any||
2605|115|I|medicines without your doctor's approval.||
2605|116|B|||
2605|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2605|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2605|119|O|poison control center right away. US residents can call||
2605|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2605|121|O|Symptoms of overdose may include: change in amount of urine,||
2605|122|O|severe drowsiness/dizziness, loss of consciousness.||
2605|123|B|||
2605|124|N|NOTES:  Do not share this medication with others.||
2605|125|N|   Lab and/or medical tests (such as liver function, fat-soluble||
2605|126|N|vitamin levels) should be done before starting this medication||
2605|127|N|and while you are taking it. Keep all medical and lab||
2605|128|N|appointments.||
2605|129|B|||
2605|130|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2605|131|D|remember. If it is more than 12 hours after the missed dose, skip||
2605|132|D|the missed dose. Take your next dose at the regular time. Do not||
2605|133|D|double the dose to catch up.||
2605|134|B|||
2605|135|R|STORAGE:  Different brands of this medication have different||
2605|136|R|storage needs. Check the product package for instructions on how||
2605|137|R|to store your brand, or ask your pharmacist. Keep all medications||
2605|138|R|away from children and pets.||
2605|139|R|   Do not flush medications down the toilet or pour them into a||
2605|140|R|drain unless instructed to do so. Properly discard this product||
2605|141|R|when it is expired or no longer needed. Consult your pharmacist||
2605|142|R|or local waste disposal company.||
2605|143|B|||
2605|144|A|Information last revised August 2024.||
2605|145|A|Copyright(c) 2025 First Databank, Inc.||
2605|146|B|||
2606|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2606|002|Z|does NOT have all possible information about this product. This||
2606|003|Z|information does not assure that this product is safe, effective,||
2606|004|Z|or appropriate for you. This information is not individual||
2606|005|Z|medical advice and does not substitute for the advice of your||
2606|006|Z|health care professional. Always ask your health care||
2606|007|Z|professional for complete information about this product and your||
2606|008|Z|specific health needs.||
2606|009|B|||
2606|010|T|EPINEPHRINE - NASAL||
2606|011|F|(EP-i-NEF-rin)||
2606|012|B|||
2606|013|C|COMMON BRAND NAME(S): Neffy||
2606|014|B|||
2606|015|U|USES:  This medication is used in emergencies to treat very||
2606|016|U|serious allergic reactions to insect stings/bites, foods, drugs,||
2606|017|U|or other substances. Epinephrine works quickly to help you||
2606|018|U|breathe better, keep your heart beating, raise dropping blood||
2606|019|U|pressure, reverse hives, and reduce swelling of the face, lips,||
2606|020|U|and throat.||
2606|021|B|||
2606|022|H|HOW TO USE:  You may still need to get emergency medical help||
2606|023|H|after you have used this medication. Before you need to use||
2606|024|H|epinephrine, ask your doctor in advance for more information.||
2606|025|H|   Read the Patient Information Leaflet and Instructions for Use||
2606|026|H|provided by your pharmacist before you need to use epinephrine||
2606|027|H|and each time you get a refill. If you have any questions, ask||
2606|028|H|your doctor or pharmacist.||
2606|029|H|   Keep this medication near you at all times. Learn ahead of||
2606|030|H|time how to properly use this medication so you will be ready if||
2606|031|H|you need to use it. Also, make sure family members, caregivers,||
2606|032|H|or other responsible household members know where you keep this||
2606|033|H|medication and how to use it in case you cannot give the||
2606|034|H|medication yourself.||
2606|035|H|   This product is for use in the nose only. The dosage is based||
2606|036|H|on your weight. Remove the epinephrine spray from the packaging||
2606|037|H|when you are ready to use it. Do not test or prime the nasal||
2606|038|H|spray before use. Doing so will make you lose the dose.||
2606|039|H|   Insert the tip of the spray nozzle into one nostril, then||
2606|040|H|firmly press the plunger up to give the dose. Do not sniff during||
2606|041|H|or immediately after you have received a dose. If symptoms||
2606|042|H|continue or get worse, give a second dose in the same nostril,||
2606|043|H|starting 5 minutes after the first dose. Each nasal spray||
2606|044|H|contains only one dose and cannot be reused.||
2606|045|H|   As directed by your doctor, get emergency medical help for||
2606|046|H|more treatment if needed. Tell the health care professional that||
2606|047|H|you have given yourself epinephrine spray.||
2606|048|B|||
2606|049|S|SIDE EFFECTS:  Nasal discomfort, runny/stuffy nose, sneezing,||
2606|050|S|irritation of the throat, headache, shaking, nervousness,||
2606|051|S|numbness, tiredness, dizziness, nausea, or vomiting may occur. If||
2606|052|S|any of these effects last or get worse, tell your doctor or||
2606|053|S|pharmacist promptly.||
2606|054|S|   Remember that this medication has been prescribed because your||
2606|055|S|doctor has judged that the benefit to you is greater than the||
2606|056|S|risk of side effects. Many people using this medication do not||
2606|057|S|have serious side effects.||
2606|058|S|   Tell your doctor right away if you have any serious side||
2606|059|S|effects, including: irregular heartbeat.||
2606|060|S|   Get medical help right away if you have any very serious side||
2606|061|S|effects, including: chest pain, fainting, vision changes,||
2606|062|S|seizures, confusion.||
2606|063|S|   This is not a complete list of possible side effects. If you||
2606|064|S|notice other effects not listed above, contact your doctor or||
2606|065|S|pharmacist.||
2606|066|S|   In the US -||
2606|067|S|   Call your doctor for medical advice about side effects. You||
2606|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2606|069|S|www.fda.gov/medwatch.||
2606|070|S|   In Canada - Call your doctor for medical advice about side||
2606|071|S|effects. You may report side effects to Health Canada at||
2606|072|S|1-866-234-2345.||
2606|073|B|||
2606|074|P|PRECAUTIONS:  Before using epinephrine, tell your doctor or||
2606|075|P|pharmacist if you are allergic to it; or if you have any other||
2606|076|P|allergies. This product may contain inactive ingredients, which||
2606|077|P|can cause allergic reactions or other problems. Talk to your||
2606|078|P|pharmacist for more details.||
2606|079|P|   This medication contains sulfites (such as sodium||
2606|080|P|metabisulfite). However, if you have a sulfite allergy, you||
2606|081|P|should still use this medication during an emergency. Since||
2606|082|P|epinephrine can save your life, using it is more important than||
2606|083|P|avoiding any sulfite-related problems.||
2606|084|P|   Before using this medication, tell your doctor or pharmacist||
2606|085|P|your medical history, especially of: diabetes, heart problems||
2606|086|P|(such as irregular heartbeat), high blood pressure, kidney||
2606|087|P|problems, nasal problems (such as injury, surgery, growths in the||
2606|088|P|nose-nasal polyps), overactive thyroid, Parkinson's disease.||
2606|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2606|090|P|can make you more dizzy. Do not drive, use machinery, or do||
2606|091|P|anything that needs alertness until you can do it safely. Limit||
2606|092|P|alcoholic beverages. Talk to your doctor if you are using||
2606|093|P|marijuana (cannabis).||
2606|094|P|   Before having surgery, tell your doctor or dentist about all||
2606|095|P|the products you use (including prescription drugs,||
2606|096|P|nonprescription drugs, and herbal products).||
2606|097|P|   Older adults may be more sensitive to the side effects of this||
2606|098|P|drug.||
2606|099|P|   Since untreated, very serious allergic reactions can harm both||
2606|100|P|a pregnant woman and her unborn baby, this medication may be used||
2606|101|P|during pregnancy.||
2606|102|P|   It is unknown if this medication passes into breast milk, but||
2606|103|P|it is unlikely to harm a nursing infant. Consult your doctor||
2606|104|P|before breastfeeding.||
2606|105|B|||
2606|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2606|107|I|medications work or increase your risk for serious side effects.||
2606|108|I|This document does not contain all possible drug interactions.||
2606|109|I|Keep a list of all the products you use (including||
2606|110|I|prescription/nonprescription drugs and herbal products) and share||
2606|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
2606|112|I|the dosage of any medicines without your doctor's approval.||
2606|113|B|||
2606|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2606|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2606|116|O|poison control center right away. US residents can call||
2606|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2606|118|O|Symptoms of overdose may include: irregular heartbeat, fainting,||
2606|119|O|vision changes, confusion, seizures.||
2606|120|B|||
2606|121|N|NOTES:  Do not share this medication with others.||
2606|122|B|||
2606|123|D|MISSED DOSE:  Not applicable.||
2606|124|B|||
2606|125|R|STORAGE:  Store at room temperature. Do not freeze. From time to||
2606|126|R|time, check the expiration date. Replace the spray before it||
2606|127|R|expires. Keep all medications away from children and pets.||
2606|128|R|   Do not flush medications down the toilet or pour them into a||
2606|129|R|drain unless instructed to do so. Properly discard this product||
2606|130|R|when it is expired or no longer needed. Consult your pharmacist||
2606|131|R|or local waste disposal company.||
2606|132|B|||
2606|133|A|Information last revised March 2025.||
2606|134|A|Copyright(c) 2025 First Databank, Inc.||
2606|135|B|||
2607|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2607|002|Z|does NOT have all possible information about this product. This||
2607|003|Z|information does not assure that this product is safe, effective,||
2607|004|Z|or appropriate for you. This information is not individual||
2607|005|Z|medical advice and does not substitute for the advice of your||
2607|006|Z|health care professional. Always ask your health care||
2607|007|Z|professional for complete information about this product and your||
2607|008|Z|specific health needs.||
2607|009|B|||
2607|010|T|MARALIXIBAT 19 MG/ML SOLUTION - ORAL||
2607|011|F|(MAR-a-LIX-i-bat)||
2607|012|B|||
2607|013|C|COMMON BRAND NAME(S): Livmarli||
2607|014|B|||
2607|015|U|USES:  This medication is used to treat skin itching caused by a||
2607|016|U|certain inherited liver condition (progressive familial||
2607|017|U|intrahepatic cholestasis-PFIC). In PFIC, a substance that your||
2607|018|U|body normally makes (bilirubin) builds up in the liver and causes||
2607|019|U|jaundice. Maralixibat belongs to a class of drugs known as ileal||
2607|020|U|bile acid transporter inhibitors. It helps to lessen symptoms of||
2607|021|U|jaundice such as itching, yellowing eyes/skin, dark urine, and||
2607|022|U|pale-colored stools.||
2607|023|B|||
2607|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
2607|025|H|Instructions for Use if available from your pharmacist before you||
2607|026|H|start using maralixibat and each time you get a refill. If you||
2607|027|H|have any questions, ask your doctor or pharmacist.||
2607|028|H|   Take this medication by mouth as directed by your doctor,||
2607|029|H|usually twice daily (once in the morning and once in the evening)||
2607|030|H|30 minutes before a meal. Carefully measure the dose using a||
2607|031|H|special measuring device/spoon. Do not use a household spoon||
2607|032|H|because you may not get the correct dose. The dosage is based on||
2607|033|H|your medical condition, weight, and response to treatment.||
2607|034|H|   To reduce your risk of side effects, your doctor may direct||
2607|035|H|you to start this medication at a low dose and gradually increase||
2607|036|H|your dose. Follow your doctor's instructions carefully.||
2607|037|H|   Use this medication regularly to get the most benefit from it.||
2607|038|H|To help you remember, take it at the same times each day.||
2607|039|H|   Do not increase your dose or use this drug more often or for||
2607|040|H|longer than prescribed. Your condition will not improve any||
2607|041|H|faster, and your risk of side effects will increase.||
2607|042|H|   If you are also taking bile acid-binding resins such as||
2607|043|H|cholestyramine, colesevelam, or colestipol, take this medication||
2607|044|H|at least 4 hours before or at least 4 hours after taking these||
2607|045|H|medications. These medications can bind to maralixibat,||
2607|046|H|preventing your body from fully absorbing the drug.||
2607|047|H|   Tell your doctor if your condition does not get better or if||
2607|048|H|it gets worse.||
2607|049|B|||
2607|050|S|SIDE EFFECTS:  Diarrhea, vomiting, or abdominal pain may occur.||
2607|051|S|If any of these effects last or get worse, tell your doctor or||
2607|052|S|pharmacist promptly.||
2607|053|S|   Remember that this medication has been prescribed because your||
2607|054|S|doctor has judged that the benefit to you is greater than the||
2607|055|S|risk of side effects. Many people using this medication do not||
2607|056|S|have serious side effects.||
2607|057|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2607|058|S|Contact your doctor promptly if you notice any symptoms of||
2607|059|S|dehydration, such as unusual decreased urination, unusual dry||
2607|060|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness.||
2607|061|S|   This medication may lower your fat-soluble vitamin levels, and||
2607|062|S|that may increase your risk for bone fractures and bleeding. Talk||
2607|063|S|to your doctor for more details.||
2607|064|S|   Although this medication is used to treat liver problems, it||
2607|065|S|may sometimes cause liver tests to worsen. Tell your doctor right||
2607|066|S|away if you have symptoms of worsening liver problems such as||
2607|067|S|nausea/vomiting that doesn't stop, loss of appetite,||
2607|068|S|stomach/abdominal pain, yellowing eyes/skin, or dark urine.||
2607|069|S|   Tell your doctor right away if you have any serious side||
2607|070|S|effects, including: abdominal pain that won't go away,||
2607|071|S|blood/mucus in stools, fever.||
2607|072|S|   A very serious allergic reaction to this drug is rare.||
2607|073|S|However, get medical help right away if you notice any symptoms||
2607|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2607|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2607|076|S|breathing.||
2607|077|S|   This is not a complete list of possible side effects. If you||
2607|078|S|notice other effects not listed above, contact your doctor or||
2607|079|S|pharmacist.||
2607|080|S|   In the US -||
2607|081|S|   Call your doctor for medical advice about side effects. You||
2607|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2607|083|S|www.fda.gov/medwatch.||
2607|084|S|   In Canada - Call your doctor for medical advice about side||
2607|085|S|effects. You may report side effects to Health Canada at||
2607|086|S|1-866-234-2345.||
2607|087|B|||
2607|088|P|PRECAUTIONS:  Before taking maralixibat, tell your doctor or||
2607|089|P|pharmacist if you are allergic to it; or if you have any other||
2607|090|P|allergies. This product may contain inactive ingredients (such as||
2607|091|P|propylene glycol), which can cause allergic reactions or other||
2607|092|P|problems. Talk to your pharmacist for more details.||
2607|093|P|   Before using this medication, tell your doctor or pharmacist||
2607|094|P|your medical history, especially of:  other liver problems (such||
2607|095|P|as ascites, encephalopathy).||
2607|096|P|   Before having surgery, tell your doctor or dentist about all||
2607|097|P|the products you use (including prescription drugs,||
2607|098|P|nonprescription drugs, and herbal products).||
2607|099|P|   Children may be more sensitive to the effects of this drug.||
2607|100|P|The propylene glycol in this medication may cause serious side||
2607|101|P|effects in children, especially children under 5 years of age.||
2607|102|P|   During pregnancy, this medication should be used only when||
2607|103|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2607|104|P|benefits with your doctor.||
2607|105|P|   It is unknown if this medication passes into breast milk.||
2607|106|P|Consult your doctor before breastfeeding.||
2607|107|B|||
2607|108|I|DRUG INTERACTIONS:  See also How to Use section.||
2607|109|I|   Drug interactions may change how your medications work or||
2607|110|I|increase your risk for serious side effects. This document does||
2607|111|I|not contain all possible drug interactions. Keep a list of all||
2607|112|I|the products you use (including prescription/nonprescription||
2607|113|I|drugs and herbal products) and share it with your doctor and||
2607|114|I|pharmacist. Do not start, stop, or change the dosage of any||
2607|115|I|medicines without your doctor's approval.||
2607|116|B|||
2607|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2607|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2607|119|O|poison control center right away. US residents can call||
2607|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2607|121|O|Symptoms of overdose may include: change in amount of urine,||
2607|122|O|severe drowsiness/dizziness, loss of consciousness.||
2607|123|B|||
2607|124|N|NOTES:  Do not share this medication with others.||
2607|125|N|   Lab and/or medical tests (such as liver function, fat-soluble||
2607|126|N|vitamin levels) should be done before starting this medication||
2607|127|N|and while you are taking it. Keep all medical and lab||
2607|128|N|appointments.||
2607|129|B|||
2607|130|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2607|131|D|remember. If it is more than 6 hours after the missed dose, skip||
2607|132|D|the missed dose. Take your next dose at the regular time. Do not||
2607|133|D|double the dose to catch up.||
2607|134|B|||
2607|135|R|STORAGE:  Before you open this product, you may store it at room||
2607|136|R|temperature away from light. Once the bottle is opened, this||
2607|137|R|medication may be stored at room temperature or in the||
2607|138|R|refrigerator and expires after 100 days. Keep all medications||
2607|139|R|away from children and pets.||
2607|140|R|   Do not flush medications down the toilet or pour them into a||
2607|141|R|drain unless instructed to do so. Properly discard this product||
2607|142|R|when it is expired or no longer needed. Consult your pharmacist||
2607|143|R|or local waste disposal company.||
2607|144|B|||
2607|145|A|Information last revised August 2024.||
2607|146|A|Copyright(c) 2025 First Databank, Inc.||
2607|147|B|||
2608|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2608|002|Z|does NOT have all possible information about this product. This||
2608|003|Z|information does not assure that this product is safe, effective,||
2608|004|Z|or appropriate for you. This information is not individual||
2608|005|Z|medical advice and does not substitute for the advice of your||
2608|006|Z|health care professional. Always ask your health care||
2608|007|Z|professional for complete information about this product and your||
2608|008|Z|specific health needs.||
2608|009|B|||
2608|010|T|SELADELPAR - ORAL||
2608|011|F|(SEL-a-DEL-par)||
2608|012|B|||
2608|013|C|COMMON BRAND NAME(S): Livdelzi||
2608|014|B|||
2608|015|U|USES:  Seladelpar is used treat a certain type of liver disease||
2608|016|U|(primary biliary cholangitis - PBC). PBC causes too much bile to||
2608|017|U|stay in the liver, which can damage the liver. Seladelpar may||
2608|018|U|work by decreasing the amount of bile that your liver makes.||
2608|019|B|||
2608|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2608|021|H|from your pharmacist before you start taking seladelpar and each||
2608|022|H|time you get a refill. If you have any questions, ask your doctor||
2608|023|H|or pharmacist.||
2608|024|H|   Take this medication by mouth with or without food as directed||
2608|025|H|by your doctor, usually once daily.||
2608|026|H|   If you also take certain drugs to lower your cholesterol (bile||
2608|027|H|acid-binding resins such as cholestyramine or colestipol), take||
2608|028|H|seladelpar at least 4 hours before or at least 4 hours after||
2608|029|H|taking these medications. These products can react with||
2608|030|H|seladelpar, preventing its full absorption.||
2608|031|H|   Do not increase your dose or take this medication more often||
2608|032|H|or for longer than prescribed. Your condition will not improve||
2608|033|H|any faster, and your risk of side effects will increase.||
2608|034|H|   Take this medication regularly to get the most benefit from||
2608|035|H|it. To help you remember, take it at the same time each day.||
2608|036|H|   Tell your doctor if your condition gets worse.||
2608|037|B|||
2608|038|S|SIDE EFFECTS:  Headache, nausea, bloating, or dizziness may||
2608|039|S|occur. If any of these effects last or get worse, tell your||
2608|040|S|doctor or pharmacist promptly.||
2608|041|S|   Remember that this medication has been prescribed because your||
2608|042|S|doctor has judged that the benefit to you is greater than the||
2608|043|S|risk of side effects. Many people using this medication do not||
2608|044|S|have serious side effects.||
2608|045|S|   Tell your doctor right away if you have any serious side||
2608|046|S|effects, including: bone pain.||
2608|047|S|   This medication may rarely cause other liver problems. Tell||
2608|048|S|your doctor right away if you notice any of these serious side||
2608|049|S|effects: nausea/vomiting that doesn't stop, loss of appetite,||
2608|050|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
2608|051|S|   A very serious allergic reaction to this drug is rare.||
2608|052|S|However, get medical help right away if you notice any symptoms||
2608|053|S|of a serious allergic reaction, including: rash, itching/swelling||
2608|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2608|055|S|breathing.||
2608|056|S|   This is not a complete list of possible side effects. If you||
2608|057|S|notice other effects not listed above, contact your doctor or||
2608|058|S|pharmacist.||
2608|059|S|   In the US -||
2608|060|S|   Call your doctor for medical advice about side effects. You||
2608|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2608|062|S|www.fda.gov/medwatch.||
2608|063|S|   In Canada - Call your doctor for medical advice about side||
2608|064|S|effects. You may report side effects to Health Canada at||
2608|065|S|1-866-234-2345.||
2608|066|B|||
2608|067|P|PRECAUTIONS:  Before taking seladelpar, tell your doctor or||
2608|068|P|pharmacist if you are allergic to it; or if you have any other||
2608|069|P|allergies. This product may contain inactive ingredients, which||
2608|070|P|can cause allergic reactions or other problems. Talk to your||
2608|071|P|pharmacist for more details.||
2608|072|P|   Before using this medication, tell your doctor or pharmacist||
2608|073|P|your medical history, especially of: other liver problems (such||
2608|074|P|as ascites, encephalopathy, biliary obstruction), osteoporosis.||
2608|075|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2608|076|P|can make you more dizzy. Do not drive, use machinery, or do||
2608|077|P|anything that needs alertness until you can do it safely. Limit||
2608|078|P|alcoholic beverages. Talk to your doctor if you are using||
2608|079|P|marijuana (cannabis).||
2608|080|P|   Before having surgery, tell your doctor or dentist about all||
2608|081|P|the products you use (including prescription drugs,||
2608|082|P|nonprescription drugs, and herbal products).||
2608|083|P|   During pregnancy, this medication should be used only when||
2608|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
2608|085|P|   It is unknown if this medication passes into breast milk.||
2608|086|P|Consult your doctor before breastfeeding.||
2608|087|B|||
2608|088|I|DRUG INTERACTIONS:  See also How to Use section.||
2608|089|I|   Drug interactions may change how your medications work or||
2608|090|I|increase your risk for serious side effects. This document does||
2608|091|I|not contain all possible drug interactions. Keep a list of all||
2608|092|I|the products you use (including prescription/nonprescription||
2608|093|I|drugs and herbal products) and share it with your doctor and||
2608|094|I|pharmacist. Do not start, stop, or change the dosage of any||
2608|095|I|medicines without your doctor's approval.||
2608|096|I|   Other medications can affect the removal of seladelpar from||
2608|097|I|your body, which may affect how seladelpar works. Examples||
2608|098|I|include azole antifungals (such as fluconazole), probenecid,||
2608|099|I|among others.||
2608|100|B|||
2608|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2608|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2608|103|O|poison control center right away. US residents can call||
2608|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2608|105|O|Symptoms of overdose may include: nausea/vomiting that doesn't||
2608|106|O|stop, muscle pain.||
2608|107|B|||
2608|108|N|NOTES:  Do not share this medication with others.||
2608|109|N|   Lab and/or medical tests (such as kidney/liver function)||
2608|110|N|should be done before you start taking this medication and while||
2608|111|N|you are taking it. Keep all medical and lab appointments. Consult||
2608|112|N|your doctor for more details.||
2608|113|B|||
2608|114|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2608|115|D|remember. If it is near the time of the next dose, skip the||
2608|116|D|missed dose. Take your next dose at the regular time. Do not||
2608|117|D|double the dose to catch up.||
2608|118|B|||
2608|119|R|STORAGE:  Store at room temperature away from light and moisture.||
2608|120|R|Do not store in the bathroom. Some brands of this medication||
2608|121|R|should be stored in their original container. Check the product||
2608|122|R|package or ask your pharmacist about your specific brand. Keep||
2608|123|R|all medications away from children and pets.||
2608|124|R|   Do not flush medications down the toilet or pour them into a||
2608|125|R|drain unless instructed to do so. Properly discard this product||
2608|126|R|when it is expired or no longer needed. Consult your pharmacist||
2608|127|R|or local waste disposal company.||
2608|128|B|||
2608|129|A|Information last revised October 2025.||
2608|130|A|Copyright(c) 2025 First Databank, Inc.||
2608|131|B|||
2609|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2609|002|Z|does NOT have all possible information about this product. This||
2609|003|Z|information does not assure that this product is safe, effective,||
2609|004|Z|or appropriate for you. This information is not individual||
2609|005|Z|medical advice and does not substitute for the advice of your||
2609|006|Z|health care professional. Always ask your health care||
2609|007|Z|professional for complete information about this product and your||
2609|008|Z|specific health needs.||
2609|009|B|||
2609|010|T|CARBIDOPA/LEVODOPA BIPHASIC EXTENDED-RELEASE CAPSULE - ORAL||
2609|011|F|(KAR-bi-DOE-pa/LEE-voe-DOE-pa)||
2609|012|B|||
2609|013|C|COMMON BRAND NAME(S): Crexont||
2609|014|B|||
2609|015|U|USES:  This medication is used to treat the symptoms of||
2609|016|U|Parkinson's disease (such as shakiness, stiffness, difficulty||
2609|017|U|moving) or Parkinson-like conditions.||
2609|018|U|   Parkinson's disease is thought to be caused by too little of a||
2609|019|U|naturally occurring substance (dopamine) in the brain. Levodopa||
2609|020|U|changes into dopamine in the brain, helping to control movement.||
2609|021|U|Carbidopa prevents the breakdown of levodopa in the bloodstream||
2609|022|U|so more levodopa can enter the brain. Carbidopa can also reduce||
2609|023|U|some of levodopa's side effects such as nausea and vomiting.||
2609|024|B|||
2609|025|H|HOW TO USE:  Take this medication by mouth as directed by your||
2609|026|H|doctor, usually 2 to 4 times a day. Avoid drinking alcoholic||
2609|027|H|beverages. Doing so may change how well the medication works and||
2609|028|H|increase the risk of side effects.||
2609|029|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
2609|030|H|Doing so can release all of the drug at once, increasing the risk||
2609|031|H|of side effects.||
2609|032|H|   This medication may be taken with or without food. However,||
2609|033|H|avoid high-protein diets because they may reduce how much of the||
2609|034|H|medication you can absorb. Also avoid taking this medication with||
2609|035|H|a high-fat, high-calorie meal since this can slow down the time||
2609|036|H|it begins to work by about 2 hours. The manufacturer says you||
2609|037|H|should take your first dose of the day about 1 to 2 hours before||
2609|038|H|eating. Ask your doctor or pharmacist how best to take this||
2609|039|H|medication.||
2609|040|H|   Separate your dose of this medication as many hours as||
2609|041|H|possible from any iron supplements or products containing iron||
2609|042|H|(such as multivitamins with minerals) you may take. Iron can||
2609|043|H|reduce the amount of carbidopa/levodopa that is absorbed by your||
2609|044|H|body.||
2609|045|H|   Do not take other forms of carbidopa or levodopa without||
2609|046|H|consulting your doctor first.||
2609|047|H|   To reduce your risk of side effects, your doctor may direct||
2609|048|H|you to start this medication at a low dose and gradually increase||
2609|049|H|your dose. Follow your doctor's instructions carefully.||
2609|050|H|   Use this medication regularly to get the most benefit from it.||
2609|051|H|To help you remember, take it at the same times each day. The||
2609|052|H|dosage is based on your medical condition and response to||
2609|053|H|treatment.||
2609|054|H|   Some people may experience a "wearing-off" effect of this||
2609|055|H|medication just before the next dose is due or an "on-off" effect||
2609|056|H|at other times. If these effects occur and bother you, tell your||
2609|057|H|doctor. Do not change your dose of this or any other medication||
2609|058|H|without checking with your doctor first.||
2609|059|H|   Do not stop taking this medication without consulting your||
2609|060|H|doctor. Some conditions may become worse when this medication is||
2609|061|H|suddenly stopped. Also, if you suddenly stop using this||
2609|062|H|medication, you may have withdrawal symptoms (such as anxiety,||
2609|063|H|depression, confusion, fever, muscle stiffness). To help prevent||
2609|064|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
2609|065|H|more likely if you have used this medication for a long time or||
2609|066|H|in high doses. Tell your doctor or pharmacist right away if you||
2609|067|H|have withdrawal.||
2609|068|H|   Tell your doctor if your condition does not get better or if||
2609|069|H|it gets worse.||
2609|070|B|||
2609|071|S|SIDE EFFECTS:  Dizziness, nausea, vomiting, trouble sleeping,||
2609|072|S|unusual dreams, or headache may occur. If any of these effects||
2609|073|S|last or get worse, tell your doctor or pharmacist promptly.||
2609|074|S|   This medication may cause urine, sweat, or saliva to turn red,||
2609|075|S|brown, or black. This effect is harmless, but your clothes may||
2609|076|S|become stained.||
2609|077|S|   To reduce the risk of dizziness and lightheadedness, get up||
2609|078|S|slowly when rising from a sitting or lying position.||
2609|079|S|   Remember that this medication has been prescribed because your||
2609|080|S|doctor has judged that the benefit to you is greater than the||
2609|081|S|risk of side effects. Many people using this medication do not||
2609|082|S|have serious side effects.||
2609|083|S|   Some people taking this medication have fallen asleep suddenly||
2609|084|S|during their usual daily activities (such as talking on the||
2609|085|S|phone, driving). In some cases, sleep occurred without any||
2609|086|S|feelings of drowsiness beforehand. This sleep effect may occur||
2609|087|S|anytime during treatment with this medication even if you have||
2609|088|S|used this medication for a long time. If you experience increased||
2609|089|S|sleepiness or fall asleep during the day, do not drive or take||
2609|090|S|part in other possibly dangerous activities until you have||
2609|091|S|discussed this effect with your doctor. Your risk of this sleep||
2609|092|S|effect is increased by using alcohol or other medications that||
2609|093|S|can make you drowsy. See also Precautions section.||
2609|094|S|   Tell your doctor right away if you have any serious side||
2609|095|S|effects, including: mental/mood changes (such as confusion,||
2609|096|S|agitation, hallucinations), unusual strong urges (such as||
2609|097|S|increased gambling, increased sexual urges), new/worsening||
2609|098|S|movements you can't control/spasms, greatly increased eye||
2609|099|S|blinking/twitching, easy bruising/bleeding, signs of infection||
2609|100|S|(such as sore throat that doesn't go away, fever, chills),||
2609|101|S|unusual tiredness, tingling of the hands/feet, vision changes||
2609|102|S|(such as blurred/double/decreased vision), eye pain, severe||
2609|103|S|stomach/abdominal pain, vomit that looks like coffee grounds,||
2609|104|S|black/tarry stools, problems with urination.||
2609|105|S|   Get medical help right away if you have any very serious side||
2609|106|S|effects, including: chest pain, fainting.||
2609|107|S|   Suddenly stopping or reducing the dose of this medication may||
2609|108|S|rarely cause a very serious condition called neuroleptic||
2609|109|S|malignant syndrome (NMS). Get medical help right away if you have||
2609|110|S|any of the following symptoms: fever, unusual muscle stiffness,||
2609|111|S|severe confusion, sweating, fast/irregular heartbeat.||
2609|112|S|   A very serious allergic reaction to this drug is rare.||
2609|113|S|However, get medical help right away if you notice any symptoms||
2609|114|S|of a serious allergic reaction, including: rash, itching/swelling||
2609|115|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2609|116|S|breathing.||
2609|117|S|   This is not a complete list of possible side effects. If you||
2609|118|S|notice other effects not listed above, contact your doctor or||
2609|119|S|pharmacist.||
2609|120|S|   In the US -||
2609|121|S|   Call your doctor for medical advice about side effects. You||
2609|122|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2609|123|S|www.fda.gov/medwatch.||
2609|124|S|   In Canada - Call your doctor for medical advice about side||
2609|125|S|effects. You may report side effects to Health Canada at||
2609|126|S|1-866-234-2345.||
2609|127|B|||
2609|128|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2609|129|P|pharmacist if you are allergic to carbidopa or levodopa; or to||
2609|130|P|foscarbidopa or foslevodopa; or if you have any other allergies.||
2609|131|P|This product may contain inactive ingredients, which can cause||
2609|132|P|allergic reactions or other problems. Talk to your pharmacist for||
2609|133|P|more details.||
2609|134|P|   Before using this medication, tell your doctor or pharmacist||
2609|135|P|your medical history, especially of: blood disorders, breathing||
2609|136|P|problems (such as asthma, emphysema), glaucoma, heart or blood||
2609|137|P|vessel problems (such as irregular heartbeat, heart attack,||
2609|138|P|angina), kidney disease, liver disease, mental/mood disorders||
2609|139|P|(such as depression, schizophrenia), ulcers of the||
2609|140|P|stomach/intestines, seizures, sleep disorder.||
2609|141|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2609|142|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2609|143|P|machinery, or do anything that needs alertness until you can do||
2609|144|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2609|145|P|are using marijuana (cannabis). See also Side Effects section.||
2609|146|P|   Before having surgery, tell your doctor or dentist about all||
2609|147|P|the products you use (including prescription drugs,||
2609|148|P|nonprescription drugs, and herbal products).||
2609|149|P|   During pregnancy, this medication should be used only when||
2609|150|P|clearly needed. Discuss the risks and benefits with your doctor.||
2609|151|P|   Levodopa passes into breast milk. It is unknown if carbidopa||
2609|152|P|passes into breast milk. Consult your doctor before||
2609|153|P|breastfeeding.||
2609|154|B|||
2609|155|I|DRUG INTERACTIONS:  See also How to Use section.||
2609|156|I|   Drug interactions may change how your medications work or||
2609|157|I|increase your risk for serious side effects. This document does||
2609|158|I|not contain all possible drug interactions. Keep a list of all||
2609|159|I|the products you use (including prescription/nonprescription||
2609|160|I|drugs and herbal products) and share it with your doctor and||
2609|161|I|pharmacist. Do not start, stop, or change the dosage of any||
2609|162|I|medicines without your doctor's approval.||
2609|163|I|   Taking MAO inhibitors with this medication may cause a serious||
2609|164|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2609|165|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2609|166|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
2609|167|I|treatment with this medication. Most MAO inhibitors should also||
2609|168|I|not be taken for two weeks before treatment with this medication.||
2609|169|I|However, certain MAO inhibitors (rasagiline, safinamide,||
2609|170|I|selegiline) may be used with careful monitoring by your doctor.||
2609|171|I|Ask your doctor when to start or stop taking this medication.||
2609|172|I|   This medication may interfere with certain lab tests (such as||
2609|173|I|urine catecholamine/glucose/ketone tests), possibly causing false||
2609|174|I|test results. Make sure lab personnel and all your doctors know||
2609|175|I|you use this drug.||
2609|176|B|||
2609|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2609|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2609|179|O|poison control center right away. US residents can call||
2609|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2609|181|O|Symptoms of overdose may include: severe dizziness, irregular||
2609|182|O|heartbeat, mental/mood changes (such as agitation).||
2609|183|B|||
2609|184|N|NOTES:  Do not share this medication with others.||
2609|185|N|   Lab and/or medical tests (such as complete blood count,||
2609|186|N|heart/kidney/liver function, blood pressure) may be done while||
2609|187|N|you are taking this medication. Keep all medical and lab||
2609|188|N|appointments. Consult your doctor for more details.||
2609|189|B|||
2609|190|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2609|191|D|remember. If it is near the time of the next dose, skip the||
2609|192|D|missed dose. Take your next dose at the regular time. Do not||
2609|193|D|double the dose to catch up.||
2609|194|B|||
2609|195|R|STORAGE:  Store at room temperature away from light and moisture.||
2609|196|R|Do not store in the bathroom. Keep all medications away from||
2609|197|R|children and pets.||
2609|198|R|   Do not flush medications down the toilet or pour them into a||
2609|199|R|drain unless instructed to do so. Properly discard this product||
2609|200|R|when it is expired or no longer needed. Consult your pharmacist||
2609|201|R|or local waste disposal company.||
2609|202|B|||
2609|203|A|Information last revised May 2025.||
2609|204|A|Copyright(c) 2025 First Databank, Inc.||
2609|205|B|||
2610|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2610|002|Z|does NOT have all possible information about this product. This||
2610|003|Z|information does not assure that this product is safe, effective,||
2610|004|Z|or appropriate for you. This information is not individual||
2610|005|Z|medical advice and does not substitute for the advice of your||
2610|006|Z|health care professional. Always ask your health care||
2610|007|Z|professional for complete information about this product and your||
2610|008|Z|specific health needs.||
2610|009|B|||
2610|010|T|LEBRIKIZUMAB - INJECTION||
2610|011|F|(LEB-ri-KIZ-ue-mab)||
2610|012|B|||
2610|013|C|COMMON BRAND NAME(S): Ebglyss||
2610|014|B|||
2610|015|U|USES:  This medication is used to treat a skin condition called||
2610|016|U|eczema (atopic dermatitis). Lebrikizumab belongs to a class of||
2610|017|U|drugs known as monoclonal antibodies. It works by blocking a||
2610|018|U|certain natural protein in your body (interleukin-13) that may||
2610|019|U|cause inflammation and swelling in eczema.||
2610|020|B|||
2610|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2610|022|H|Instructions for Use if available from your pharmacist before you||
2610|023|H|start using this medication and each time you get a refill. Ask||
2610|024|H|your health care professional how to prepare and use this||
2610|025|H|medication. If you have any questions, ask your doctor or||
2610|026|H|pharmacist.||
2610|027|H|   Inject this medication under the skin as directed by your||
2610|028|H|doctor, usually once every 2 or 4 weeks. The injection is given||
2610|029|H|in the upper arms, thighs, or abdomen (except for a 2-inch area||
2610|030|H|around your belly button).||
2610|031|H|   Do not shake the medication. Before using, check this product||
2610|032|H|for cloudiness, particles, or discoloration. If you see any of||
2610|033|H|these things, do not use the liquid. Before injecting each dose,||
2610|034|H|clean the skin you are going to inject into (the injection site)||
2610|035|H|with rubbing alcohol. Change the injection site each time to||
2610|036|H|lessen injury under the skin. Do not inject into skin that is||
2610|037|H|tender, bruised, red, hard, or in an area of skin that is||
2610|038|H|affected by atopic dermatitis or skin lesions. To lessen||
2610|039|H|bruising, do not rub the injection site after a shot. Learn how||
2610|040|H|to store and discard medical supplies safely.||
2610|041|H|   Use this medication regularly to get the most benefit from it.||
2610|042|H|To help you remember, mark your calendar with a reminder.||
2610|043|H|   Tell your doctor if your condition does not get better or if||
2610|044|H|it gets worse.||
2610|045|B|||
2610|046|S|SIDE EFFECTS:  Eye redness/itching/discharge may occur. Pain,||
2610|047|S|redness, or swelling at the injection site may also occur. If any||
2610|048|S|of these effects last or get worse, tell your doctor or||
2610|049|S|pharmacist promptly.||
2610|050|S|   Remember that this medication has been prescribed because your||
2610|051|S|doctor has judged that the benefit to you is greater than the||
2610|052|S|risk of side effects. Many people using this medication do not||
2610|053|S|have serious side effects.||
2610|054|S|   Tell your doctor right away if you have any serious side||
2610|055|S|effects, including: other eye problems (such as eye pain, changes||
2610|056|S|in vision).||
2610|057|S|   A very serious allergic reaction to this drug is rare.||
2610|058|S|However, get medical help right away if you notice any symptoms||
2610|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2610|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2610|061|S|breathing.||
2610|062|S|   This is not a complete list of possible side effects. If you||
2610|063|S|notice other effects not listed above, contact your doctor or||
2610|064|S|pharmacist.||
2610|065|S|   In the US -||
2610|066|S|   Call your doctor for medical advice about side effects. You||
2610|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2610|068|S|www.fda.gov/medwatch.||
2610|069|S|   In Canada - Call your doctor for medical advice about side||
2610|070|S|effects. You may report side effects to Health Canada at||
2610|071|S|1-866-234-2345.||
2610|072|B|||
2610|073|P|PRECAUTIONS:  Before using lebrikizumab, tell your doctor or||
2610|074|P|pharmacist if you are allergic to it; or if you have any other||
2610|075|P|allergies. This product may contain inactive ingredients, which||
2610|076|P|can cause allergic reactions or other problems. Talk to your||
2610|077|P|pharmacist for more details.||
2610|078|P|   Before using this medication, tell your doctor or pharmacist||
2610|079|P|your medical history, especially of: a certain type of infection||
2610|080|P|(helminth).||
2610|081|P|   Tell your health care professional that you are using||
2610|082|P|lebrikizumab before having any immunizations/vaccinations.||
2610|083|P|   Before having surgery, tell your doctor or dentist about all||
2610|084|P|the products you use (including prescription drugs,||
2610|085|P|nonprescription drugs, and herbal products).||
2610|086|P|   During pregnancy, this medication should be used only when||
2610|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
2610|088|P|   It is unknown if this medication passes into breast milk.||
2610|089|P|Consult your doctor before breastfeeding.||
2610|090|B|||
2610|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2610|092|I|medications work or increase your risk for serious side effects.||
2610|093|I|This document does not contain all possible drug interactions.||
2610|094|I|Keep a list of all the products you use (including||
2610|095|I|prescription/nonprescription drugs and herbal products) and share||
2610|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
2610|097|I|the dosage of any medicines without your doctor's approval.||
2610|098|B|||
2610|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2610|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2610|101|O|poison control center right away. US residents can call||
2610|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2610|103|B|||
2610|104|N|NOTES:  Do not share this medication with others.||
2610|105|B|||
2610|106|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2610|107|D|Use your next dose on your regular schedule (for example, 2 or 4||
2610|108|D|weeks later). Do not double the dose to catch up.||
2610|109|B|||
2610|110|R|STORAGE:  Store in the refrigerator. Do not freeze. Do not use||
2610|111|R|this medication if it has been frozen. Keep the medication in the||
2610|112|R|original carton to protect from light. This medication may also||
2610|113|R|be stored at room temperature if needed. If the medication is||
2610|114|R|stored at room temperature, discard after 7 days. Keep all||
2610|115|R|medications away from children and pets.||
2610|116|R|   Do not flush medications down the toilet or pour them into a||
2610|117|R|drain unless instructed to do so. Properly discard this product||
2610|118|R|when it is expired or no longer needed. Consult your pharmacist||
2610|119|R|or local waste disposal company.||
2610|120|B|||
2610|121|A|Information last revised October 2025.||
2610|122|A|Copyright(c) 2025 First Databank, Inc.||
2610|123|B|||
2611|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2611|002|Z|does NOT have all possible information about this product. This||
2611|003|Z|information does not assure that this product is safe, effective,||
2611|004|Z|or appropriate for you. This information is not individual||
2611|005|Z|medical advice and does not substitute for the advice of your||
2611|006|Z|health care professional. Always ask your health care||
2611|007|Z|professional for complete information about this product and your||
2611|008|Z|specific health needs.||
2611|009|B|||
2611|010|T|CLONIDINE EXTENDED-RELEASE SUSPENSION - ORAL||
2611|011|F|(KLON-i-deen)||
2611|012|B|||
2611|013|C|COMMON BRAND NAME(S): Onyda XR||
2611|014|B|||
2611|015|U|USES:  This medication is used alone or with other medications to||
2611|016|U|treat attention deficit hyperactivity disorder (ADHD) as part of||
2611|017|U|a total treatment plan, including psychological, social, and||
2611|018|U|other treatments.||
2611|019|B|||
2611|020|V|OTHER USES:  This section contains uses of this drug that are not||
2611|021|V|listed in the approved professional labeling for the drug but||
2611|022|V|that may be prescribed by your health care professional. Use this||
2611|023|V|drug for a condition that is listed in this section only if it||
2611|024|V|has been so prescribed by your health care professional.||
2611|025|V|   This medication may also be used for high blood pressure||
2611|026|V|(hypertension) and to help people quit smoking.||
2611|027|B|||
2611|028|H|HOW TO USE:  Read the Patient Information Leaflet and||
2611|029|H|Instructions for Use if available from your pharmacist before you||
2611|030|H|start taking clonidine and each time you get a refill. If you||
2611|031|H|have any questions, ask your doctor or pharmacist.||
2611|032|H|   Take this medication by mouth with or without food as directed||
2611|033|H|by your doctor, usually once daily at bedtime.||
2611|034|H|   Shake the bottle gently for at least 10 seconds before each||
2611|035|H|dose. Carefully measure the dose using the oral syringe that||
2611|036|H|comes with the medication. Do not use a household spoon because||
2611|037|H|you may not get the correct dose. Rinse the syringe with water||
2611|038|H|after each use. Consult your pharmacist if you have any||
2611|039|H|questions.||
2611|040|H|   The dosage is based on your medical condition and response to||
2611|041|H|treatment. To reduce your risk of side effects, your doctor may||
2611|042|H|direct you to start this medication at a low dose and gradually||
2611|043|H|increase your dose. Follow your doctor's instructions carefully.||
2611|044|H|   Use this medication regularly to get the most benefit from it.||
2611|045|H|To help you remember, take it at the same time each day. Keep||
2611|046|H|taking this medication even if you feel well.||
2611|047|H|   Do not stop taking this medication without consulting your||
2611|048|H|doctor. You may experience symptoms such as headache, fast||
2611|049|H|heartbeat, nausea, anxiety, and flushing. A rapid rise in blood||
2611|050|H|pressure may also occur when the drug is suddenly stopped. The||
2611|051|H|risk is greater if you have used this drug for a long time or in||
2611|052|H|high doses, or if you are also taking a beta blocker (such as||
2611|053|H|atenolol). There have also been rare reports of severe, possibly||
2611|054|H|fatal reactions (such as stroke) from stopping this drug too||
2611|055|H|quickly. It is important that you do not run out of clonidine or||
2611|056|H|miss any doses. Tell your doctor or pharmacist right away if you||
2611|057|H|are unable to take the medication (for example, due to vomiting).||
2611|058|H|To prevent any reactions while you are stopping treatment with||
2611|059|H|this drug, your doctor may reduce your dose gradually. Consult||
2611|060|H|your doctor or pharmacist for more details. Report any new or||
2611|061|H|worsening symptoms right away.||
2611|062|H|   Other forms of this medication (such as immediate-release||
2611|063|H|tablets) may deliver different amounts of this medication. Do not||
2611|064|H|switch between the different forms of this medication without||
2611|065|H|your doctor's permission and directions. Also, do not take other||
2611|066|H|clonidine-containing products while taking this medication.||
2611|067|H|   Tell your doctor if your condition does not get better or if||
2611|068|H|it gets worse.||
2611|069|B|||
2611|070|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, tiredness,||
2611|071|S|dry mouth, or constipation may occur. If any of these effects||
2611|072|S|last or get worse, tell your doctor or pharmacist promptly.||
2611|073|S|   To reduce the risk of dizziness and lightheadedness, get up||
2611|074|S|slowly when rising from a sitting or lying position.||
2611|075|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
2611|076|S|chips, chew (sugarless) gum, drink water, or use a saliva||
2611|077|S|substitute.||
2611|078|S|   Remember that this medication has been prescribed because your||
2611|079|S|doctor has judged that the benefit to you is greater than the||
2611|080|S|risk of side effects. Many people using this medication do not||
2611|081|S|have serious side effects.||
2611|082|S|   Tell your doctor right away if you have any serious side||
2611|083|S|effects, including: fainting, slow/irregular heartbeat,||
2611|084|S|mental/mood changes (such as irritability, depression).||
2611|085|S|   A very serious allergic reaction to this drug is rare.||
2611|086|S|However, get medical help right away if you notice any symptoms||
2611|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2611|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2611|089|S|breathing.||
2611|090|S|   This is not a complete list of possible side effects. If you||
2611|091|S|notice other effects not listed above, contact your doctor or||
2611|092|S|pharmacist.||
2611|093|S|   In the US -||
2611|094|S|   Call your doctor for medical advice about side effects. You||
2611|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2611|096|S|www.fda.gov/medwatch.||
2611|097|S|   In Canada - Call your doctor for medical advice about side||
2611|098|S|effects. You may report side effects to Health Canada at||
2611|099|S|1-866-234-2345.||
2611|100|B|||
2611|101|P|PRECAUTIONS:  Before taking clonidine, tell your doctor or||
2611|102|P|pharmacist if you are allergic to it (including having a rash||
2611|103|P|while using clonidine patches); or if you have any other||
2611|104|P|allergies. This product may contain inactive ingredients, which||
2611|105|P|can cause allergic reactions or other problems. Talk to your||
2611|106|P|pharmacist for more details.||
2611|107|P|   Before using this medication, tell your doctor or pharmacist||
2611|108|P|your medical history, especially of: heart rhythm problems (such||
2611|109|P|as slow/irregular heartbeat), stroke, low blood pressure, kidney||
2611|110|P|disease.||
2611|111|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2611|112|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2611|113|P|machinery, or do anything that needs alertness until you can do||
2611|114|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2611|115|P|are using marijuana (cannabis).||
2611|116|P|   This medication may contain sugar. Caution is advised if you||
2611|117|P|have diabetes or any other condition that requires you to limit||
2611|118|P|sugar in your diet. Ask your doctor or pharmacist about using||
2611|119|P|this product safely.||
2611|120|P|   Before having surgery, tell your doctor or dentist about all||
2611|121|P|the products you use (including prescription drugs,||
2611|122|P|nonprescription drugs, and herbal products).||
2611|123|P|   Contact lens wearers may need to use wetting eye drops since||
2611|124|P|this medication can cause dry eyes.||
2611|125|P|   Older adults may be more sensitive to the side effects of this||
2611|126|P|drug, especially dizziness, or drowsiness. These side effects may||
2611|127|P|increase the risk of falling.||
2611|128|P|   During pregnancy, this medication should be used only when||
2611|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
2611|130|P|   This drug passes into breast milk and may have undesirable||
2611|131|P|effects on a nursing infant. Consult your doctor before||
2611|132|P|breastfeeding.||
2611|133|B|||
2611|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2611|135|I|medications work or increase your risk for serious side effects.||
2611|136|I|This document does not contain all possible drug interactions.||
2611|137|I|Keep a list of all the products you use (including||
2611|138|I|prescription/nonprescription drugs and herbal products) and share||
2611|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
2611|140|I|the dosage of any medicines without your doctor's approval.||
2611|141|I|   Tell your doctor or pharmacist if you are using other products||
2611|142|I|that cause drowsiness such as opioid pain or cough relievers||
2611|143|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2611|144|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2611|145|I|zolpidem), muscle relaxants (such as carisoprodol,||
2611|146|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2611|147|I|diphenhydramine).||
2611|148|I|   Check the labels on all your medicines (such as allergy or||
2611|149|I|cough-and-cold products) because they may contain ingredients||
2611|150|I|that cause drowsiness. Ask your pharmacist about using those||
2611|151|I|products safely.||
2611|152|B|||
2611|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2611|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2611|155|O|poison control center right away. US residents can call||
2611|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2611|157|O|Symptoms of overdose may include: severe dizziness/drowsiness,||
2611|158|O|fainting, slow/irregular heartbeat, slow/shallow breathing,||
2611|159|O|seizures.||
2611|160|B|||
2611|161|N|NOTES:  Do not share this medication with others.||
2611|162|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
2611|163|N|should be done while you are taking this medication. Keep all||
2611|164|N|medical and lab appointments. Consult your doctor for more||
2611|165|N|details.||
2611|166|B|||
2611|167|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2611|168|D|next dose at the regular time. Do not double the dose to catch||
2611|169|D|up. If you miss 2 or more doses in a row, contact your doctor||
2611|170|D|right away.||
2611|171|B|||
2611|172|R|STORAGE:  Store in the original bottle at room temperature away||
2611|173|R|from light. Once the bottle is opened, this medication expires||
2611|174|R|after 30 or 60 days (depending on your product). Tightly close||
2611|175|R|the bottle when not in use. Keep all medications away from||
2611|176|R|children and pets.||
2611|177|R|   Do not flush medications down the toilet or pour them into a||
2611|178|R|drain unless instructed to do so. Properly discard this product||
2611|179|R|when it is expired or no longer needed. Consult your pharmacist||
2611|180|R|or local waste disposal company.||
2611|181|B|||
2611|182|A|Information last revised June 2025.||
2611|183|A|Copyright(c) 2025 First Databank, Inc.||
2611|184|B|||
2612|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2612|002|Z|does NOT have all possible information about this product. This||
2612|003|Z|information does not assure that this product is safe, effective,||
2612|004|Z|or appropriate for you. This information is not individual||
2612|005|Z|medical advice and does not substitute for the advice of your||
2612|006|Z|health care professional. Always ask your health care||
2612|007|Z|professional for complete information about this product and your||
2612|008|Z|specific health needs.||
2612|009|B|||
2612|010|T|TISLELIZUMAB - INJECTION||
2612|011|F|(TIS-le-LIZ-ue-mab)||
2612|012|B|||
2612|013|C|COMMON BRAND NAME(S): Tevimbra||
2612|014|B|||
2612|015|U|USES:  Tislelizumab is used to treat certain types of cancer||
2612|016|U|(esophageal, stomach). It works by changing the action of your||
2612|017|U|own immune system, directing it to attack cancer cells.||
2612|018|U|Tislelizumab belongs to a class of drugs known as monoclonal||
2612|019|U|antibodies.||
2612|020|B|||
2612|021|H|HOW TO USE:  Read the Medication Guide provided by your||
2612|022|H|pharmacist before you start receiving tislelizumab and each time||
2612|023|H|you get a treatment. If you have any questions, ask your doctor||
2612|024|H|or pharmacist.||
2612|025|H|   This medication is given by a health care professional. It is||
2612|026|H|given as directed by your doctor, usually once every 2 to 4||
2612|027|H|weeks.||
2612|028|H|   Infusion reactions may happen during the infusion of this||
2612|029|H|drug. Tell your doctor right away if you have any symptoms of||
2612|030|H|infusion reactions such as fever, chills, shaking, flushing,||
2612|031|H|itching, rash, shortness of breath, dizziness, or back/neck pain.||
2612|032|H|Your doctor may slow down or stop your treatment for some time.||
2612|033|H|   Use this medication regularly to get the most benefit from it.||
2612|034|H|To help you remember, mark your calendar with a reminder.||
2612|035|B|||
2612|036|S|SIDE EFFECTS:  See also How to Use section.||
2612|037|S|   Tiredness or weight loss may occur. If either of these effects||
2612|038|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
2612|039|S|   People using this medication may have serious side effects.||
2612|040|S|However, you have been prescribed this drug because your doctor||
2612|041|S|has judged that the benefit to you is greater than the risk of||
2612|042|S|side effects. Careful monitoring by your doctor may decrease your||
2612|043|S|risk.||
2612|044|S|   Tell your doctor right away if you have any serious side||
2612|045|S|effects, including: new/worsening cough, diarrhea with||
2612|046|S|blood/mucus, severe stomach/abdominal pain, mouth/throat sores,||
2612|047|S|symptoms of liver disease (such as nausea/vomiting that doesn't||
2612|048|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
2612|049|S|eyes/skin, dark urine), signs of kidney problems (such as change||
2612|050|S|in the amount of urine, pink/bloody urine), easy||
2612|051|S|bruising/bleeding, swelling hands/ankles/feet, unusual weakness,||
2612|052|S|joint stiffness/pain, muscle||
2612|053|S|weakness/tenderness/pain/spasms/cramps, numbness/tingling of||
2612|054|S|arms/legs, loss of coordination, eye redness/pain/sensitivity to||
2612|055|S|light, vision changes, headache that is unusual or doesn't go||
2612|056|S|away, seizures.||
2612|057|S|   Tislelizumab may cause hormone gland problems (such as||
2612|058|S|thyroid, pituitary, adrenal, pancreas). Your body could make too||
2612|059|S|much or too little hormone. Tell your doctor right away if you||
2612|060|S|have any symptoms such as: cold or heat intolerance, unexplained||
2612|061|S|weight loss/gain, increased thirst/urination, mood or behavior||
2612|062|S|changes (such as decreased sex drive, irritability,||
2612|063|S|forgetfulness), slow/fast/pounding/irregular heartbeat, unusual||
2612|064|S|tiredness, constipation.||
2612|065|S|   This medication may rarely make your blood sugar rise, which||
2612|066|S|can cause or worsen diabetes. Tell your doctor right away if you||
2612|067|S|have symptoms of high blood sugar such as increased||
2612|068|S|thirst/urination. If you already have diabetes, check your blood||
2612|069|S|sugar regularly as directed and share the results with your||
2612|070|S|doctor. Your doctor may need to adjust your diabetes medication,||
2612|071|S|exercise program, or diet.||
2612|072|S|   Get medical help right away if you have any very serious side||
2612|073|S|effects, including: chest pain, shortness of breath.||
2612|074|S|   A very serious allergic reaction to this drug is rare.||
2612|075|S|However, get medical help right away if you notice any symptoms||
2612|076|S|of a serious allergic reaction, including: fever, swollen lymph||
2612|077|S|nodes, rash, itching/swelling (especially of the||
2612|078|S|face/tongue/throat), severe dizziness, trouble breathing.||
2612|079|S|   This is not a complete list of possible side effects. If you||
2612|080|S|notice other effects not listed above, contact your doctor or||
2612|081|S|pharmacist.||
2612|082|S|   In the US -||
2612|083|S|   Call your doctor for medical advice about side effects. You||
2612|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2612|085|S|www.fda.gov/medwatch.||
2612|086|S|   In Canada - Call your doctor for medical advice about side||
2612|087|S|effects. You may report side effects to Health Canada at||
2612|088|S|1-866-234-2345.||
2612|089|B|||
2612|090|P|PRECAUTIONS:  Before using tislelizumab, tell your doctor or||
2612|091|P|pharmacist if you are allergic to it; or if you have any other||
2612|092|P|allergies. This product may contain inactive ingredients, which||
2612|093|P|can cause allergic reactions or other problems. Talk to your||
2612|094|P|pharmacist for more details.||
2612|095|P|   Before using this medication, tell your doctor or pharmacist||
2612|096|P|your medical history, especially of: organ transplant, radiation||
2612|097|P|treatment, stem cell transplant with donor cells.||
2612|098|P|   Before having surgery, tell your doctor or dentist about all||
2612|099|P|the products you use (including prescription drugs,||
2612|100|P|nonprescription drugs, and herbal products).||
2612|101|P|   Tell your doctor if you are pregnant or plan to become||
2612|102|P|pregnant. You should not become pregnant while using||
2612|103|P|tislelizumab. Tislelizumab may harm an unborn baby. Your doctor||
2612|104|P|should order a pregnancy test before you start this medication.||
2612|105|P|Ask about reliable forms of birth control while using this||
2612|106|P|medication and for 4 months after the last dose. If you become||
2612|107|P|pregnant, talk to your doctor right away about the risks and||
2612|108|P|benefits of this medication.||
2612|109|P|   It is unknown if this medication passes into breast milk.||
2612|110|P|Because of the possible risk to the infant, breastfeeding is not||
2612|111|P|recommended while using this medication and for 4 months after||
2612|112|P|the last dose. Consult your doctor before breastfeeding.||
2612|113|B|||
2612|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2612|115|I|medications work or increase your risk for serious side effects.||
2612|116|I|This document does not contain all possible drug interactions.||
2612|117|I|Keep a list of all the products you use (including||
2612|118|I|prescription/nonprescription drugs and herbal products) and share||
2612|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
2612|120|I|the dosage of any medicines without your doctor's approval.||
2612|121|B|||
2612|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2612|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2612|124|O|poison control center right away. US residents can call||
2612|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2612|126|B|||
2612|127|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
2612|128|N|function, blood sugar) should be done before you start using this||
2612|129|N|medication and while you are using it. Keep all medical and lab||
2612|130|N|appointments. Consult your doctor for more details.||
2612|131|B|||
2612|132|D|MISSED DOSE:  It is important to get each dose of this medication||
2612|133|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2612|134|D|right away for a new dosing schedule.||
2612|135|B|||
2612|136|R|STORAGE:  Not applicable. This medication is given in a hospital||
2612|137|R|or clinic and will not be stored at home.||
2612|138|B|||
2612|139|A|Information last revised April 2025.||
2612|140|A|Copyright(c) 2025 First Databank, Inc.||
2612|141|B|||
2613|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2613|002|Z|does NOT have all possible information about this product. This||
2613|003|Z|information does not assure that this product is safe, effective,||
2613|004|Z|or appropriate for you. This information is not individual||
2613|005|Z|medical advice and does not substitute for the advice of your||
2613|006|Z|health care professional. Always ask your health care||
2613|007|Z|professional for complete information about this product and your||
2613|008|Z|specific health needs.||
2613|009|B|||
2613|010|T|LAZERTINIB - ORAL||
2613|011|B|||
2613|012|C|COMMON BRAND NAME(S): Lazcluze||
2613|013|B|||
2613|014|U|USES:  This medication is used in combination with another||
2613|015|U|medication (amivantamab) to treat lung cancer. Lazertinib belongs||
2613|016|U|to a class of drugs known as kinase inhibitors. It works by||
2613|017|U|slowing or stopping the growth of cancer cells.||
2613|018|B|||
2613|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2613|020|H|from your pharmacist before you start taking lazertinib and each||
2613|021|H|time you get a refill. If you have any questions, ask your doctor||
2613|022|H|or pharmacist.||
2613|023|H|   Take this medication by mouth with or without food as directed||
2613|024|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2613|025|H|not crush or chew the tablets.||
2613|026|H|   The dosage is based on your medical condition and response to||
2613|027|H|treatment.||
2613|028|H|   If you vomit your dose of lazertinib, do not take another||
2613|029|H|dose. Take your next dose at your regular scheduled time. Do not||
2613|030|H|take two doses at the same time.||
2613|031|H|   Use this medication regularly to get the most benefit from it.||
2613|032|H|To help you remember, take it at the same time each day.||
2613|033|H|   Do not increase your dose or use this drug more often or for||
2613|034|H|longer than prescribed. Your condition will not improve any||
2613|035|H|faster, and your risk of serious side effects will increase.||
2613|036|H|   Since this drug can be absorbed through the skin and lungs and||
2613|037|H|may harm an unborn baby, women who are pregnant or who may become||
2613|038|H|pregnant should not handle this medication or breathe the dust||
2613|039|H|from the tablets.||
2613|040|B|||
2613|041|S|SIDE EFFECTS:  Dry/itchy skin, tiredness, muscle/joint pain,||
2613|042|S|nausea/vomiting, diarrhea or constipation, mouth sores, abdominal||
2613|043|S|pain, decreased appetite, headache, or dizziness may occur. If||
2613|044|S|any of these effects last or get worse, tell your doctor or||
2613|045|S|pharmacist promptly.||
2613|046|S|   An alcohol-free moisturizer may help to reduce the risk of dry||
2613|047|S|skin and other skin problems. In some cases, your doctor may||
2613|048|S|prescribe antibiotics to help prevent or relieve these||
2613|049|S|conditions.||
2613|050|S|   People using this medication may have serious side effects.||
2613|051|S|However, you have been prescribed this drug because your doctor||
2613|052|S|has judged that the benefit to you is greater than the risk of||
2613|053|S|side effects. Careful monitoring by your doctor may decrease your||
2613|054|S|risk.||
2613|055|S|   Tell your doctor right away if you have any serious side||
2613|056|S|effects, including: signs of new/worsening lung disease (such as||
2613|057|S|cough, shortness of breath), vision changes (such as blurred||
2613|058|S|vision, sensitivity to light), eye pain/redness, swelling||
2613|059|S|ankles/feet/hands, numbness/tingling of arms/legs,||
2613|060|S|redness/swelling/pain around the nails, easy bruising/bleeding.||
2613|061|S|   Lazertinib may cause blood clots in the lungs or legs. Your||
2613|062|S|doctor should prescribe an anticoagulant while you are taking||
2613|063|S|this medication, especially during the first 4 months of||
2613|064|S|treatment. Get medical help right away if any of these side||
2613|065|S|effects occur: chest pain, trouble breathing,||
2613|066|S|pain/swelling/warmth in the groin/calf.||
2613|067|S|   This medication may lower your ability to fight infections.||
2613|068|S|This may make you more likely to get a serious (rarely fatal)||
2613|069|S|infection or make any infection you have worse. Tell your doctor||
2613|070|S|right away if you have any signs of infection (such as sore||
2613|071|S|throat that doesn't go away, fever, chills).||
2613|072|S|   This medication can commonly cause a mild rash that is usually||
2613|073|S|not serious. However, you may not be able to tell it apart from a||
2613|074|S|rare rash that could be a sign of a severe allergic reaction. Get||
2613|075|S|medical help right away if you develop any rash.||
2613|076|S|   A very serious allergic reaction to this drug is rare.||
2613|077|S|However, get medical help right away if you notice any symptoms||
2613|078|S|of a serious allergic reaction, including: rash, itching/swelling||
2613|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2613|080|S|breathing.||
2613|081|S|   This is not a complete list of possible side effects. If you||
2613|082|S|notice other effects not listed above, contact your doctor or||
2613|083|S|pharmacist.||
2613|084|S|   In the US -||
2613|085|S|   Call your doctor for medical advice about side effects. You||
2613|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2613|087|S|www.fda.gov/medwatch.||
2613|088|S|   In Canada - Call your doctor for medical advice about side||
2613|089|S|effects. You may report side effects to Health Canada at||
2613|090|S|1-866-234-2345.||
2613|091|B|||
2613|092|P|PRECAUTIONS:  Before taking lazertinib, tell your doctor or||
2613|093|P|pharmacist if you are allergic to it; or if you have any other||
2613|094|P|allergies. This product may contain inactive ingredients, which||
2613|095|P|can cause allergic reactions or other problems. Talk to your||
2613|096|P|pharmacist for more details.||
2613|097|P|   Before using this medication, tell your doctor or pharmacist||
2613|098|P|your medical history.||
2613|099|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2613|100|P|can make you more dizzy. Do not drive, use machinery, or do||
2613|101|P|anything that needs alertness until you can do it safely. Limit||
2613|102|P|alcoholic beverages. Talk to your doctor if you are using||
2613|103|P|marijuana (cannabis).||
2613|104|P|   Lazertinib can make you more likely to get infections or may||
2613|105|P|make current infections worse. Stay away from anyone who has an||
2613|106|P|infection that may easily spread (such as chickenpox, COVID-19,||
2613|107|P|measles, flu). Talk to your doctor if you have been exposed to an||
2613|108|P|infection or for more details.||
2613|109|P|   Tell your health care professional that you are using||
2613|110|P|lazertinib before having any immunizations/vaccinations. Avoid||
2613|111|P|contact with people who have recently received live vaccines||
2613|112|P|(such as flu vaccine inhaled through the nose).||
2613|113|P|   This medication may make you more sensitive to the sun. Limit||
2613|114|P|your time in the sun while you receive this medication and for 2||
2613|115|P|months after stopping treatment. Avoid tanning booths and||
2613|116|P|sunlamps. Use sunscreen and wear protective clothing when||
2613|117|P|outdoors. Tell your doctor right away if you get sunburned or||
2613|118|P|have skin blisters/redness.||
2613|119|P|   Before having surgery, tell your doctor or dentist about all||
2613|120|P|the products you use (including prescription drugs,||
2613|121|P|nonprescription drugs, and herbal products).||
2613|122|P|   Since this drug can be absorbed through the skin and lungs and||
2613|123|P|may harm an unborn baby, women who are pregnant or who may become||
2613|124|P|pregnant should not handle this medication or breathe the dust||
2613|125|P|from the tablets.||
2613|126|P|   Tell your doctor if you are pregnant or plan to become||
2613|127|P|pregnant. You should not become pregnant while using lazertinib.||
2613|128|P|Lazertinib may harm an unborn baby. Your doctor should order a||
2613|129|P|pregnancy test before you start this medication. Men and women||
2613|130|P|using this medication should ask about reliable forms of birth||
2613|131|P|control during treatment and for 3 weeks after the last dose. If||
2613|132|P|you or your partner becomes pregnant, talk to your doctor right||
2613|133|P|away about the risks and benefits of this medication.||
2613|134|P|   It is unknown if this drug passes into breast milk. Because of||
2613|135|P|the possible risk to the infant, breastfeeding is not recommended||
2613|136|P|while using this drug and for 3 weeks after the last dose.||
2613|137|P|Consult your doctor before breastfeeding.||
2613|138|B|||
2613|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2613|140|I|medications work or increase your risk for serious side effects.||
2613|141|I|This document does not contain all possible drug interactions.||
2613|142|I|Keep a list of all the products you use (including||
2613|143|I|prescription/nonprescription drugs and herbal products) and share||
2613|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
2613|145|I|the dosage of any medicines without your doctor's approval.||
2613|146|I|   Other medications can affect the removal of lazertinib from||
2613|147|I|your body, which may affect how lazertinib works. Examples||
2613|148|I|include efavirenz, rifamycins (such as rifampin), among others.||
2613|149|B|||
2613|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2613|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2613|152|O|poison control center right away. US residents can call||
2613|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2613|154|B|||
2613|155|N|NOTES:  Do not share this medication with others.||
2613|156|N|   Lab and/or medical tests (such as kidney/liver function,||
2613|157|N|complete blood count, eye exams) should be done while you are||
2613|158|N|using this medication. Keep all medical and lab appointments.||
2613|159|N|Consult your doctor for more details.||
2613|160|B|||
2613|161|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2613|162|D|remember. If it is more than 12 hours after the missed dose, skip||
2613|163|D|the missed dose. Take your next dose at the regular time. Do not||
2613|164|D|double the dose to catch up.||
2613|165|B|||
2613|166|R|STORAGE:  Store at room temperature away from light and moisture.||
2613|167|R|Do not store in the bathroom. Keep all medications away from||
2613|168|R|children and pets.||
2613|169|R|   Do not flush medications down the toilet or pour them into a||
2613|170|R|drain unless instructed to do so. Properly discard this product||
2613|171|R|when it is expired or no longer needed. Consult your pharmacist||
2613|172|R|or local waste disposal company.||
2613|173|B|||
2613|174|A|Information last revised November 2025.||
2613|175|A|Copyright(c) 2025 First Databank, Inc.||
2613|176|B|||
2614|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2614|002|Z|does NOT have all possible information about this product. This||
2614|003|Z|information does not assure that this product is safe, effective,||
2614|004|Z|or appropriate for you. This information is not individual||
2614|005|Z|medical advice and does not substitute for the advice of your||
2614|006|Z|health care professional. Always ask your health care||
2614|007|Z|professional for complete information about this product and your||
2614|008|Z|specific health needs.||
2614|009|B|||
2614|010|T|CLOBETASOL - OPHTHALMIC||
2614|011|F|(kloe-BAY-ta-sol)||
2614|012|B|||
2614|013|C|COMMON BRAND NAME(S): Byqlovi||
2614|014|B|||
2614|015|U|USES:  This medication is used to treat swelling (inflammation)||
2614|016|U|and pain after eye surgery. Clobetasol works by relieving||
2614|017|U|symptoms such as swelling, redness, and itching. It belongs to a||
2614|018|U|class of drugs known as corticosteroids.||
2614|019|B|||
2614|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
2614|021|H|directed by your doctor, usually 2 times daily. This medication||
2614|022|H|is usually started 1 day after surgery and continued for 2 weeks||
2614|023|H|after surgery. Follow your doctor's instructions carefully.||
2614|024|H|   To apply eye drops, wash hands first. To avoid contamination,||
2614|025|H|do not touch the dropper tip or let it touch your eye or any||
2614|026|H|other surface.||
2614|027|H|   If you are wearing contact lenses, remove them before using||
2614|028|H|eye drops. Contact lenses may absorb the preservative in this||
2614|029|H|product. Wait at least 15 minutes before replacing your contact||
2614|030|H|lenses.||
2614|031|H|   Tilt your head back, look upward, and pull down the lower||
2614|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2614|033|H|and place one drop into the pouch. Look downward, gently close||
2614|034|H|your eyes, and place one finger at the corner of your eye (near||
2614|035|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2614|036|H|opening your eyes. This will prevent the medication from draining||
2614|037|H|out. Try not to blink or rub your eye. If directed to use this||
2614|038|H|medication in both eyes, repeat these steps for your other eye.||
2614|039|H|Do not rinse the dropper. Replace the dropper cap after each use.||
2614|040|H|   If you are using another kind of eye medication (such as drops||
2614|041|H|or ointments), wait at least 5 minutes before applying other||
2614|042|H|medications. Use eye drops before eye ointments to allow the||
2614|043|H|drops to enter the eye.||
2614|044|H|   Wait several minutes for your vision to clear before driving||
2614|045|H|or operating machinery.||
2614|046|H|   Use this medication regularly to get the most benefit from it.||
2614|047|H|To help you remember, use it at the same times each day.||
2614|048|H|   This medication is used as directed by your doctor, usually||
2614|049|H|for 14 days after eye surgery. Do not start using this medication||
2614|050|H|early, use it more often than prescribed, or keep using it for||
2614|051|H|longer than directed by your doctor.||
2614|052|H|   Continue to use this medication for the full time prescribed.||
2614|053|H|Do not stop using this medication without consulting your doctor.||
2614|054|H|Some conditions may become worse when the drug is suddenly||
2614|055|H|stopped. Your dose may need to be gradually decreased.||
2614|056|H|   Tell your doctor if your condition lasts or gets worse.||
2614|057|B|||
2614|058|S|SIDE EFFECTS:  Eye discomfort, redness, or sensitivity to light||
2614|059|S|may occur. If any of these effects last or get worse, tell your||
2614|060|S|doctor or pharmacist promptly.||
2614|061|S|   Remember that this medication has been prescribed because your||
2614|062|S|doctor has judged that the benefit to you is greater than the||
2614|063|S|risk of side effects. Many people using this medication do not||
2614|064|S|have serious side effects.||
2614|065|S|   Use of this medication for long periods or in high doses may||
2614|066|S|cause serious eye problems (such as cataracts or high pressure||
2614|067|S|inside the eyes). Tell your doctor right away if either of these||
2614|068|S|serious side effects occur: vision problems, eye pain.||
2614|069|S|   This medication may mask the signs of an eye infection. It may||
2614|070|S|also put you at greater risk of developing an eye infection,||
2614|071|S|especially with longer use. Report any new or worsening symptoms||
2614|072|S|such as eye discharge/swelling/redness, vision problems, or no||
2614|073|S|improvement of your current eye condition. Your doctor will need||
2614|074|S|to adjust your treatment.||
2614|075|S|   Tell your doctor right away if you have any serious side||
2614|076|S|effects, including: headache, dizziness.||
2614|077|S|   A very serious allergic reaction to this drug is rare.||
2614|078|S|However, get medical help right away if you notice any symptoms||
2614|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2614|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2614|081|S|breathing.||
2614|082|S|   This is not a complete list of possible side effects. If you||
2614|083|S|notice other effects not listed above, contact your doctor or||
2614|084|S|pharmacist.||
2614|085|S|   In the US -||
2614|086|S|   Call your doctor for medical advice about side effects. You||
2614|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2614|088|S|www.fda.gov/medwatch.||
2614|089|S|   In Canada - Call your doctor for medical advice about side||
2614|090|S|effects. You may report side effects to Health Canada at||
2614|091|S|1-866-234-2345.||
2614|092|B|||
2614|093|P|PRECAUTIONS:  Before using clobetasol, tell your doctor or||
2614|094|P|pharmacist if you are allergic to it; or if you have any other||
2614|095|P|allergies. This product may contain inactive ingredients (such as||
2614|096|P|preservatives like benzalkonium chloride), which can cause||
2614|097|P|allergic reactions or other problems. Talk to your pharmacist for||
2614|098|P|more details.||
2614|099|P|   Before using this medication, tell your doctor or pharmacist||
2614|100|P|your medical history, especially of: eye infections, recent eye||
2614|101|P|surgery, cataracts, glaucoma (open-angle type), severe||
2614|102|P|nearsightedness (myopia), diabetes.||
2614|103|P|   After you apply this drug, your vision may become temporarily||
2614|104|P|blurred. Do not drive, use machinery, or do any activity that||
2614|105|P|requires clear vision until you can do it safely.||
2614|106|P|   Before having surgery, tell your doctor or dentist about all||
2614|107|P|the products you use (including prescription drugs,||
2614|108|P|nonprescription drugs, and herbal products).||
2614|109|P|   If you have a new eye infection or injury, or need eye||
2614|110|P|surgery, ask your doctor if you should continue to use your||
2614|111|P|current bottle of clobetasol eye drops or start a new bottle.||
2614|112|P|   During pregnancy, this medication should be used only when||
2614|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
2614|114|P|   It is unknown if this drug passes into breast milk. Consult||
2614|115|P|your doctor before breastfeeding.||
2614|116|B|||
2614|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2614|118|I|medications work or increase your risk for serious side effects.||
2614|119|I|This document does not contain all possible drug interactions.||
2614|120|I|Keep a list of all the products you use (including||
2614|121|I|prescription/nonprescription drugs and herbal products) and share||
2614|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
2614|123|I|the dosage of any medicines without your doctor's approval.||
2614|124|B|||
2614|125|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2614|126|O|has overdosed and has serious symptoms such as passing out or||
2614|127|O|trouble breathing, call 911. Otherwise, call a poison control||
2614|128|O|center right away. US residents can call 1-800-222-1222. Canada||
2614|129|O|residents can call 1-844-764-7669.||
2614|130|B|||
2614|131|N|NOTES:  Do not share this medication with others.||
2614|132|N|   This medication has been prescribed for your current condition||
2614|133|N|only. Do not use it later for another eye condition unless your||
2614|134|N|doctor tells you to.||
2614|135|N|   Lab and/or medical tests (such as eye exams, measurement of||
2614|136|N|the pressure inside the eyes) may be done while you are using||
2614|137|N|this medication. Keep all medical and lab appointments. Consult||
2614|138|N|your doctor for more details.||
2614|139|B|||
2614|140|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2614|141|D|If it is near the time of the next dose, skip the missed dose.||
2614|142|D|Use your next dose at the regular time. Do not double the dose to||
2614|143|D|catch up.||
2614|144|B|||
2614|145|R|STORAGE:  Store the bottle upright at room temperature. Do not||
2614|146|R|freeze. Keep all medications away from children and pets.||
2614|147|R|   Do not flush medications down the toilet or pour them into a||
2614|148|R|drain unless instructed to do so. Properly discard this product||
2614|149|R|when it is expired or no longer needed. Consult your pharmacist||
2614|150|R|or local waste disposal company.||
2614|151|B|||
2614|152|A|Information last revised September 2024.||
2614|153|A|Copyright(c) 2025 First Databank, Inc.||
2614|154|B|||
2615|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2615|002|Z|does NOT have all possible information about this product. This||
2615|003|Z|information does not assure that this product is safe, effective,||
2615|004|Z|or appropriate for you. This information is not individual||
2615|005|Z|medical advice and does not substitute for the advice of your||
2615|006|Z|health care professional. Always ask your health care||
2615|007|Z|professional for complete information about this product and your||
2615|008|Z|specific health needs.||
2615|009|B|||
2615|010|T|PALOPEGTERIPARATIDE - INJECTION||
2615|011|B|||
2615|012|C|COMMON BRAND NAME(S): Yorvipath||
2615|013|B|||
2615|014|U|USES:  Palopegteriparatide is a man-made form of parathyroid||
2615|015|U|hormone, a certain natural substance made by the body.||
2615|016|U|Parathyroid hormone helps maintain the balance of calcium and||
2615|017|U|phosphorus in the body. This medication is used to treat low||
2615|018|U|levels of parathyroid hormone.||
2615|019|B|||
2615|020|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2615|021|H|provided by your pharmacist before you start using||
2615|022|H|palopegteriparatide and each time you get a refill. Ask your||
2615|023|H|health care professional how to prepare and use this medication.||
2615|024|H|If you have any questions, ask your doctor or pharmacist.||
2615|025|H|   Inject this medication under the skin as directed by your||
2615|026|H|doctor, usually once daily. The injection is given in the thighs||
2615|027|H|or abdomen (except for a 2-inch area around your belly button).||
2615|028|H|The dosage is based on your medical condition, lab tests, and||
2615|029|H|response to treatment.||
2615|030|H|   If you are using a new pen, take the medication out of the||
2615|031|H|refrigerator at least 20 minutes before you inject it to allow it||
2615|032|H|to reach room temperature. Do not warm up this medication any||
2615|033|H|other way (for example, do not heat it in the microwave, place it||
2615|034|H|in hot water, or leave it in direct sunlight).||
2615|035|H|   Before using, check this product for cloudiness, particles, or||
2615|036|H|discoloration. If you see any of these things, do not use the||
2615|037|H|liquid. Before injecting each dose, clean the skin you are going||
2615|038|H|to inject into (the injection site) with rubbing alcohol. Change||
2615|039|H|the injection site each time to lessen injury under the skin. Do||
2615|040|H|not inject into skin that is red, swollen, or scarred. To lessen||
2615|041|H|bruising, do not rub the injection site after a shot. Learn how||
2615|042|H|to store and discard medical supplies safely.||
2615|043|H|   Use this medication regularly to get the most benefit from it.||
2615|044|H|To help you remember, use it at the same time each day.||
2615|045|H|   Tell your doctor if your condition does not get better or if||
2615|046|H|it gets worse.||
2615|047|B|||
2615|048|S|SIDE EFFECTS:  Dizziness, lightheadedness, or fast heartbeat may||
2615|049|S|occur right after using this medication. If these effects occur,||
2615|050|S|sit or lie down right away. Giving your dose at bedtime or||
2615|051|S|getting up slowly from a sitting or lying position may also help||
2615|052|S|lessen these effects. Bruising/redness at the injection site,||
2615|053|S|headache, diarrhea, back pain, or sore throat may also occur. If||
2615|054|S|any of these effects last or get worse, tell your doctor or||
2615|055|S|pharmacist promptly.||
2615|056|S|   Remember that this medication has been prescribed because your||
2615|057|S|doctor has judged that the benefit to you is greater than the||
2615|058|S|risk of side effects. Many people using this medication do not||
2615|059|S|have serious side effects.||
2615|060|S|   High blood calcium can occur, especially when you first start||
2615|061|S|using this medication and after a dose increase. Tell your doctor||
2615|062|S|right away if you have symptoms such as nausea, vomiting,||
2615|063|S|constipation, unusual thirst, muscle weakness, unusual tiredness,||
2615|064|S|confusion, or irregular heartbeat.||
2615|065|S|   Low blood calcium can also occur, especially if you stop using||
2615|066|S|this medication, or if you miss a dose of this medication. Tell||
2615|067|S|your doctor right away if you develop symptoms of low blood||
2615|068|S|calcium, such as tingling in your fingertips/toes/lips/tongue,||
2615|069|S|muscle spasms/cramps, numbness in your mouth, depression,||
2615|070|S|problems thinking or remembering, or seizures.||
2615|071|S|   Tell your doctor right away if you have any serious side||
2615|072|S|effects, including: fainting.||
2615|073|S|   Medications like palopegteriparatide have been shown to||
2615|074|S|increase bone cancer (osteosarcoma) in rats. It is unknown if||
2615|075|S|palopegteriparatide can cause bone cancer in humans. Tell your||
2615|076|S|doctor right away if you have any symptoms of bone cancer,||
2615|077|S|including: bone pain, unusual growths/lumps.||
2615|078|S|   A very serious allergic reaction to this drug is rare.||
2615|079|S|However, get medical help right away if you notice any symptoms||
2615|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2615|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2615|082|S|breathing.||
2615|083|S|   This is not a complete list of possible side effects. If you||
2615|084|S|notice other effects not listed above, contact your doctor or||
2615|085|S|pharmacist.||
2615|086|S|   In the US -||
2615|087|S|   Call your doctor for medical advice about side effects. You||
2615|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2615|089|S|www.fda.gov/medwatch.||
2615|090|S|   In Canada - Call your doctor for medical advice about side||
2615|091|S|effects. You may report side effects to Health Canada at||
2615|092|S|1-866-234-2345.||
2615|093|B|||
2615|094|P|PRECAUTIONS:  Before using palopegteriparatide, tell your doctor||
2615|095|P|or pharmacist if you are allergic to it; or if you have any other||
2615|096|P|allergies. This product may contain inactive ingredients, which||
2615|097|P|can cause allergic reactions or other problems. Talk to your||
2615|098|P|pharmacist for more details.||
2615|099|P|   Before using this medication, tell your doctor or pharmacist||
2615|100|P|your medical history, especially of: bone diseases (such as||
2615|101|P|Paget's disease), personal/family history of bone cancer,||
2615|102|P|radiation treatment, high level of calcium in the blood||
2615|103|P|(hypercalcemia), kidney stones.||
2615|104|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2615|105|P|can make you more dizzy. Do not drive, use machinery, or do||
2615|106|P|anything that needs alertness until you can do it safely. Limit||
2615|107|P|alcoholic beverages. Talk to your doctor if you are using||
2615|108|P|marijuana (cannabis).||
2615|109|P|   Before having surgery, tell your doctor or dentist about all||
2615|110|P|the products you use (including prescription drugs,||
2615|111|P|nonprescription drugs, and herbal products).||
2615|112|P|   During pregnancy, this medication should be used only when||
2615|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
2615|114|P|   It is unknown if this medication passes into breast milk.||
2615|115|P|Consult your doctor before breastfeeding.||
2615|116|B|||
2615|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2615|118|I|medications work or increase your risk for serious side effects.||
2615|119|I|This document does not contain all possible drug interactions.||
2615|120|I|Keep a list of all the products you use (including||
2615|121|I|prescription/nonprescription drugs and herbal products) and share||
2615|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
2615|123|I|the dosage of any medicines without your doctor's approval.||
2615|124|B|||
2615|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2615|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2615|127|O|poison control center right away. US residents can call||
2615|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2615|129|B|||
2615|130|N|NOTES:  Do not share this medication with others.||
2615|131|N|   Lab and/or medical tests (such as calcium/vitamin D levels)||
2615|132|N|should be done before you start using this medication and while||
2615|133|N|you are using it. Keep all medical and lab appointments. Consult||
2615|134|N|your doctor for more details.||
2615|135|B|||
2615|136|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2615|137|D|If it is more than 12 hours after the missed dose, skip the||
2615|138|D|missed dose. Use your next dose at the regular time. If you miss||
2615|139|D|3 or more doses in a row, contact your doctor or pharmacist right||
2615|140|D|away. Do not double the dose to catch up.||
2615|141|B|||
2615|142|R|STORAGE:  Store unused medication in the refrigerator. Do not||
2615|143|R|freeze. Keep the medication in the original packaging to protect||
2615|144|R|from light. After first use, store the medication at room||
2615|145|R|temperature and discard after 14 days. Keep all medications away||
2615|146|R|from children and pets.||
2615|147|R|   Do not flush medications down the toilet or pour them into a||
2615|148|R|drain unless instructed to do so. Properly discard this product||
2615|149|R|when it is expired or no longer needed. Consult your pharmacist||
2615|150|R|or local waste disposal company.||
2615|151|B|||
2615|152|A|Information last revised September 2024.||
2615|153|A|Copyright(c) 2025 First Databank, Inc.||
2615|154|B|||
2616|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2616|002|Z|does NOT have all possible information about this product. This||
2616|003|Z|information does not assure that this product is safe, effective,||
2616|004|Z|or appropriate for you. This information is not individual||
2616|005|Z|medical advice and does not substitute for the advice of your||
2616|006|Z|health care professional. Always ask your health care||
2616|007|Z|professional for complete information about this product and your||
2616|008|Z|specific health needs.||
2616|009|B|||
2616|010|T|ATEZOLIZUMAB/HYALURONIDASE - SUBCUTANEOUS INJECTION||
2616|011|F|(A-te-zoe-LIZ-ue-mab/HYE-al-ure-ON-i-dase)||
2616|012|B|||
2616|013|C|COMMON BRAND NAME(S): Tecentriq Hybreza||
2616|014|B|||
2616|015|U|USES:  This medication is used to treat various cancers (such as||
2616|016|U|liver/lung/skin cancer, alveolar soft part sarcoma - ASPS). It||
2616|017|U|contains 2 ingredients: atezolizumab and hyaluronidase.||
2616|018|U|Atezolizumab belongs to a class of drugs known as monoclonal||
2616|019|U|antibodies. It works by helping your immune system fight the||
2616|020|U|cancer. Hyaluronidase is used to help the body absorb||
2616|021|U|atezolizumab, which helps it work better.||
2616|022|B|||
2616|023|H|HOW TO USE:  Read the Medication Guide provided by your||
2616|024|H|pharmacist before you start using atezolizumab/hyaluronidase and||
2616|025|H|each time you get a treatment. If you have any questions, ask||
2616|026|H|your doctor or pharmacist.||
2616|027|H|   This medication is given by injection under the skin by a||
2616|028|H|health care professional. It is injected slowly into the thigh||
2616|029|H|over 7 minutes. It is given as directed by your doctor, usually||
2616|030|H|once every 3 weeks.||
2616|031|H|   Injection reactions may happen during the injection of this||
2616|032|H|drug. Tell your doctor right away if you have any symptoms of||
2616|033|H|injection reactions such as chills, itching, shortness of breath,||
2616|034|H|flushing, dizziness, lightheadedness, fever, back/neck pain. Your||
2616|035|H|doctor may give you other medications to help with these side||
2616|036|H|effects or may slow down or stop your treatment for some time.||
2616|037|H|   Use this medication regularly to get the most benefit from it.||
2616|038|H|To help you remember, mark your calendar with a reminder.||
2616|039|B|||
2616|040|S|SIDE EFFECTS:  See also How to Use section.||
2616|041|S|   Tiredness, loss of appetite, muscle/bone pain, or nausea may||
2616|042|S|occur. If any of these effects last or get worse, tell your||
2616|043|S|doctor or pharmacist promptly.||
2616|044|S|   Remember that this medication has been prescribed because your||
2616|045|S|doctor has judged that the benefit to you is greater than the||
2616|046|S|risk of side effects. Many people using this medication do not||
2616|047|S|have serious side effects.||
2616|048|S|   Tell your doctor right away if you have any serious side||
2616|049|S|effects, including: new/worsening cough, diarrhea, black/tarry||
2616|050|S|stool, signs of liver disease (nausea/vomiting that doesn't stop,||
2616|051|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2616|052|S|of kidney problems (such as pink/bloody urine, change in the||
2616|053|S|amount of urine), eye/vision problems (such as blurred vision,||
2616|054|S|vision changes, eye pain), headache that is severe or doesn't go||
2616|055|S|away, stiff/painful neck, numbness/tingling of arms/legs.||
2616|056|S|   This medication may cause hormone gland problems (such as||
2616|057|S|thyroid, pituitary, adrenal, pancreas). Your body could make too||
2616|058|S|much or too little hormone. Tell your doctor right away if you||
2616|059|S|have any symptoms such as: cold or heat intolerance, unexplained||
2616|060|S|weight loss/gain, increased thirst/urination, mood or behavior||
2616|061|S|changes (such as decreased sex drive, irritability,||
2616|062|S|forgetfulness), slow/fast/pounding/irregular heartbeat, unusual||
2616|063|S|tiredness, constipation.||
2616|064|S|   Get medical help right away if you have any very serious side||
2616|065|S|effects, including: chest pain, shortness of breath.||
2616|066|S|   A very serious allergic reaction to this drug is rare.||
2616|067|S|However, get medical help right away if you notice any symptoms||
2616|068|S|of a serious allergic reaction, including: fever, swollen lymph||
2616|069|S|nodes, rash, itching/swelling (especially of the||
2616|070|S|face/tongue/throat), severe dizziness, trouble breathing.||
2616|071|S|   This is not a complete list of possible side effects. If you||
2616|072|S|notice other effects not listed above, contact your doctor or||
2616|073|S|pharmacist.||
2616|074|S|   In the US -||
2616|075|S|   Call your doctor for medical advice about side effects. You||
2616|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2616|077|S|www.fda.gov/medwatch.||
2616|078|S|   In Canada - Call your doctor for medical advice about side||
2616|079|S|effects. You may report side effects to Health Canada at||
2616|080|S|1-866-234-2345.||
2616|081|B|||
2616|082|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2616|083|P|pharmacist if you are allergic to atezolizumab or hyaluronidase;||
2616|084|P|or if you have any other allergies. This product may contain||
2616|085|P|inactive ingredients, which can cause allergic reactions or other||
2616|086|P|problems. Talk to your pharmacist for more details.||
2616|087|P|   Before using this medication, tell your doctor or pharmacist||
2616|088|P|your medical history, especially of: immune system problems (such||
2616|089|P|as Crohn's disease, ulcerative colitis, lupus), organ transplant,||
2616|090|P|stem cell transplant with donor cells, radiation treatment,||
2616|091|P|nervous system disorders (such as myasthenia gravis,||
2616|092|P|Guillain-Barre syndrome), diabetes.||
2616|093|P|   Before having surgery, tell your doctor or dentist about all||
2616|094|P|the products you use (including prescription drugs,||
2616|095|P|nonprescription drugs, and herbal products).||
2616|096|P|   Tell your doctor if you are pregnant or plan to become||
2616|097|P|pregnant. You should not become pregnant while using this||
2616|098|P|medication. Atezolizumab may harm an unborn baby. Ask about||
2616|099|P|reliable forms of birth control while using this medication and||
2616|100|P|for 5 months after the last dose. If you become pregnant, talk to||
2616|101|P|your doctor right away about the risks and benefits of this||
2616|102|P|medication.||
2616|103|P|   It is unknown if this drug passes into breast milk. Because of||
2616|104|P|the possible risk to the infant, breastfeeding is not recommended||
2616|105|P|while using this drug and for 5 months after the last dose.||
2616|106|P|Consult your doctor before breastfeeding.||
2616|107|B|||
2616|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2616|109|I|medications work or increase your risk for serious side effects.||
2616|110|I|This document does not contain all possible drug interactions.||
2616|111|I|Keep a list of all the products you use (including||
2616|112|I|prescription/nonprescription drugs and herbal products) and share||
2616|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
2616|114|I|the dosage of any medicines without your doctor's approval.||
2616|115|B|||
2616|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2616|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2616|118|O|poison control center right away. US residents can call||
2616|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2616|120|B|||
2616|121|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
2616|122|N|function) should be done before you start using this medication||
2616|123|N|and while you are using it. Keep all medical and lab||
2616|124|N|appointments. Consult your doctor for more details.||
2616|125|B|||
2616|126|D|MISSED DOSE:  It is important to get each dose of this medication||
2616|127|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2616|128|D|right away for a new dosing schedule.||
2616|129|B|||
2616|130|R|STORAGE:  Not applicable. This medication is given in a hospital||
2616|131|R|or clinic and will not be stored at home.||
2616|132|B|||
2616|133|A|Information last revised January 2025.||
2616|134|A|Copyright(c) 2025 First Databank, Inc.||
2616|135|B|||
2617|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2617|002|Z|does NOT have all possible information about this product. This||
2617|003|Z|information does not assure that this product is safe, effective,||
2617|004|Z|or appropriate for you. This information is not individual||
2617|005|Z|medical advice and does not substitute for the advice of your||
2617|006|Z|health care professional. Always ask your health care||
2617|007|Z|professional for complete information about this product and your||
2617|008|Z|specific health needs.||
2617|009|B|||
2617|010|T|OCRELIZUMAB/HYALURONIDASE - SUBCUTANEOUS INJECTION||
2617|011|F|(OK-re-LIZ-ue-mab/HYE-al-ure-ON-i-dase)||
2617|012|B|||
2617|013|C|COMMON BRAND NAME(S): Ocrevus Zunovo||
2617|014|B|||
2617|015|U|USES:  This medication is used to treat certain forms of multiple||
2617|016|U|sclerosis-MS (relapsing or primary progressive forms). It||
2617|017|U|contains 2 ingredients: ocrelizumab and hyaluronidase. This||
2617|018|U|medication is not a cure for MS, but it is thought to help slow||
2617|019|U|down nerve damage, reduce the number of relapses, and delay||
2617|020|U|disability. Ocrelizumab belongs to a class of drugs known as||
2617|021|U|monoclonal antibodies. Hyaluronidase is used to help the body||
2617|022|U|absorb ocrelizumab, which helps it work better.||
2617|023|B|||
2617|024|H|HOW TO USE:  Read the Medication Guide provided by your||
2617|025|H|pharmacist before you start using ocrelizumab/hyaluronidase and||
2617|026|H|each time you get a treatment. If you have any questions, ask||
2617|027|H|your doctor or pharmacist.||
2617|028|H|   This medication is given by injection under the skin by a||
2617|029|H|health care professional. It is injected slowly into the abdomen||
2617|030|H|over 10 minutes. It is given as directed by your doctor, usually||
2617|031|H|once every 6 months.||
2617|032|H|   Injection reactions may happen during the injection of this||
2617|033|H|drug and for up to 24 hours afterward. Your doctor may prescribe||
2617|034|H|other medications (including acetaminophen, a corticosteroid such||
2617|035|H|as dexamethasone, an antihistamine such as diphenhydramine) to||
2617|036|H|help prevent these side effects. Tell your doctor right away if||
2617|037|H|you have any symptoms of injection reactions such as pain,||
2617|038|H|redness, swelling, itching, headache, or nausea. Your doctor may||
2617|039|H|give you other medications to help with these side effects or may||
2617|040|H|slow down or stop your treatment for some time.||
2617|041|B|||
2617|042|S|SIDE EFFECTS:  See also How to Use section.||
2617|043|S|   Cold symptoms such as stuffy/runny nose or cough may occur. If||
2617|044|S|any of these effects last or get worse, tell your doctor or||
2617|045|S|pharmacist promptly.||
2617|046|S|   Remember that this medication has been prescribed because your||
2617|047|S|doctor has judged that the benefit to you is greater than the||
2617|048|S|risk of side effects. Many people using this medication do not||
2617|049|S|have serious side effects.||
2617|050|S|   Tell your doctor right away if you have any serious side||
2617|051|S|effects, including: diarrhea, stomach/abdominal pain,||
2617|052|S|bloody/black/tarry stool, signs of liver problems (such as||
2617|053|S|nausea/vomiting that doesn't stop, loss of appetite, yellowing||
2617|054|S|eyes/skin, dark urine).||
2617|055|S|   This medication may lower your ability to fight infections.||
2617|056|S|This may make you more likely to get a serious (rarely fatal)||
2617|057|S|infection or make any infection you have worse. Tell your doctor||
2617|058|S|right away if you have any signs of infection (such as sore||
2617|059|S|throat that doesn't go away, fever, chills, herpes cold sores or||
2617|060|S|genital sores, shingles).||
2617|061|S|   This medication may rarely increase your risk of developing||
2617|062|S|cancer, including breast cancer. Tell your doctor right away if||
2617|063|S|you have symptoms such as unusual growths, a lump in the breast,||
2617|064|S|nipple discharge. Ask your doctor for more details.||
2617|065|S|   This medication may increase your risk of getting a rare but||
2617|066|S|very serious (possibly fatal) brain infection (progressive||
2617|067|S|multifocal leukoencephalopathy-PML). Get medical help right away||
2617|068|S|if you have any of these new or worsening side effects:||
2617|069|S|clumsiness, loss of coordination/balance, weakness, sudden change||
2617|070|S|in your thinking (such as confusion, difficulty concentrating,||
2617|071|S|memory loss), difficulty talking/walking, seizure, vision||
2617|072|S|changes.||
2617|073|S|   A very serious allergic reaction to this drug is rare.||
2617|074|S|However, get medical help right away if you notice any symptoms||
2617|075|S|of a serious allergic reaction, including: rash, itching/swelling||
2617|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2617|077|S|breathing.||
2617|078|S|   This is not a complete list of possible side effects. If you||
2617|079|S|notice other effects not listed above, contact your doctor or||
2617|080|S|pharmacist.||
2617|081|S|   In the US -||
2617|082|S|   Call your doctor for medical advice about side effects. You||
2617|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2617|084|S|www.fda.gov/medwatch.||
2617|085|S|   In Canada - Call your doctor for medical advice about side||
2617|086|S|effects. You may report side effects to Health Canada at||
2617|087|S|1-866-234-2345.||
2617|088|B|||
2617|089|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2617|090|P|pharmacist if you are allergic to ocrelizumab or hyaluronidase;||
2617|091|P|or if you have any other allergies. This product may contain||
2617|092|P|inactive ingredients, which can cause allergic reactions or other||
2617|093|P|problems. Talk to your pharmacist for more details.||
2617|094|P|   Before using this medication, tell your doctor or pharmacist||
2617|095|P|your medical history, especially of: current/past/returning||
2617|096|P|infections (such as herpes, tuberculosis), liver problems (such||
2617|097|P|as hepatitis B).||
2617|098|P|   This medication can make you more likely to get infections or||
2617|099|P|may make current infections worse. Stay away from anyone who has||
2617|100|P|an infection that may easily spread (such as chickenpox,||
2617|101|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2617|102|P|exposed to an infection or for more details.||
2617|103|P|   Tell your health care professional that you are using||
2617|104|P|ocrelizumab/hyaluronidase before having any||
2617|105|P|immunizations/vaccinations. Avoid contact with people who have||
2617|106|P|recently received live vaccines (such as flu vaccine inhaled||
2617|107|P|through the nose).||
2617|108|P|   Before having surgery, tell your doctor or dentist about all||
2617|109|P|the products you use (including prescription drugs,||
2617|110|P|nonprescription drugs, and herbal products).||
2617|111|P|   Tell your doctor if you are pregnant or plan to become||
2617|112|P|pregnant. You should not become pregnant while using this||
2617|113|P|medication. Ocrelizumab may harm an unborn baby. Ask about||
2617|114|P|reliable forms of birth control while using this medication and||
2617|115|P|for 6 months after the last dose. If you become pregnant, talk to||
2617|116|P|your doctor right away about the risks and benefits of this||
2617|117|P|medication.||
2617|118|P|   It is unknown if this medication passes into breast milk.||
2617|119|P|Consult your doctor before breastfeeding.||
2617|120|B|||
2617|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2617|122|I|medications work or increase your risk for serious side effects.||
2617|123|I|This document does not contain all possible drug interactions.||
2617|124|I|Keep a list of all the products you use (including||
2617|125|I|prescription/nonprescription drugs and herbal products) and share||
2617|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
2617|127|I|the dosage of any medicines without your doctor's approval.||
2617|128|I|   Some products that may interact with this drug are: other||
2617|129|I|drugs that weaken the immune system/increase the risk of||
2617|130|I|infection (such as natalizumab, rituximab).||
2617|131|B|||
2617|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2617|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2617|134|O|poison control center right away. US residents can call||
2617|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2617|136|B|||
2617|137|N|NOTES:  Lab and/or medical tests (such as tests for hepatitis B,||
2617|138|N|liver function, breast cancer screening, immunoglobulin levels)||
2617|139|N|should be done before you start using this medication and while||
2617|140|N|you are using it. Keep all medical and lab appointments. Consult||
2617|141|N|your doctor for more details.||
2617|142|B|||
2617|143|D|MISSED DOSE:  It is important to get each dose of this medication||
2617|144|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2617|145|D|right away for a new dosing schedule.||
2617|146|B|||
2617|147|R|STORAGE:  Not applicable. This medication is given in a hospital||
2617|148|R|or clinic and will not be stored at home.||
2617|149|B|||
2617|150|M|MEDICAL ALERT:  Your condition can cause complications in a||
2617|151|M|medical emergency. For information about enrolling in MedicAlert,||
2617|152|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2617|153|B|||
2617|154|A|Information last revised August 2025.||
2617|155|A|Copyright(c) 2025 First Databank, Inc.||
2617|156|B|||
2618|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2618|002|Z|does NOT have all possible information about this product. This||
2618|003|Z|information does not assure that this product is safe, effective,||
2618|004|Z|or appropriate for you. This information is not individual||
2618|005|Z|medical advice and does not substitute for the advice of your||
2618|006|Z|health care professional. Always ask your health care||
2618|007|Z|professional for complete information about this product and your||
2618|008|Z|specific health needs.||
2618|009|B|||
2618|010|T|XANOMELINE/TROSPIUM - ORAL||
2618|011|F|(zan-OH-me-leen/TROSE-pee-um)||
2618|012|B|||
2618|013|C|COMMON BRAND NAME(S): Cobenfy||
2618|014|B|||
2618|015|U|USES:  This combination medication is used to treat a certain||
2618|016|U|mental/mood disorder (schizophrenia). Xanomeline works by helping||
2618|017|U|to restore the balance of certain natural substances in the||
2618|018|U|brain. Trospium helps to reduce some of xanomeline's side||
2618|019|U|effects.||
2618|020|B|||
2618|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2618|022|H|from your pharmacist before you start taking this medication and||
2618|023|H|each time you get a refill. If you have any questions, ask your||
2618|024|H|doctor or pharmacist.||
2618|025|H|   Take this medication by mouth on an empty stomach (at least||
2618|026|H|one hour before a meal or at least two hours after a meal) as||
2618|027|H|directed by your doctor, usually twice daily. Do not open the||
2618|028|H|capsules. The dosage is based on your medical condition and||
2618|029|H|response to treatment.||
2618|030|H|   To reduce your risk of side effects, your doctor may direct||
2618|031|H|you to start this medication at a low dose and gradually increase||
2618|032|H|your dose. Follow your doctor's instructions carefully.||
2618|033|H|   Use this medication regularly to get the most benefit from it.||
2618|034|H|To help you remember, take it at the same times each day.||
2618|035|H|   Do not increase your dose or use this drug more often or for||
2618|036|H|longer than prescribed. Your condition will not improve any||
2618|037|H|faster, and your risk of side effects will increase.||
2618|038|H|   Tell your doctor if your condition lasts or gets worse.||
2618|039|B|||
2618|040|S|SIDE EFFECTS:  Dizziness, drowsiness, constipation, stomach||
2618|041|S|upset, nausea, vomiting, diarrhea, blurred vision, or dry mouth||
2618|042|S|may occur. If any of these effects last or get worse, tell your||
2618|043|S|doctor or pharmacist promptly.||
2618|044|S|   Remember that this medication has been prescribed because your||
2618|045|S|doctor has judged that the benefit to you is greater than the||
2618|046|S|risk of side effects. Many people using this medication do not||
2618|047|S|have serious side effects.||
2618|048|S|   This medication may raise your blood pressure. Check your||
2618|049|S|blood pressure regularly and tell your doctor if the results are||
2618|050|S|high.||
2618|051|S|   Tell your doctor right away if you have any serious side||
2618|052|S|effects, including: eye pain, vision problems, difficulty||
2618|053|S|urinating, fast heartbeat, mental/mood changes (such as||
2618|054|S|hallucinations, confusion), symptoms of liver disease (such as||
2618|055|S|nausea/vomiting that doesn't stop, loss of appetite,||
2618|056|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2618|057|S|   A very serious allergic reaction to this drug is rare.||
2618|058|S|However, get medical help right away if you notice any symptoms||
2618|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2618|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2618|061|S|breathing.||
2618|062|S|   This is not a complete list of possible side effects. If you||
2618|063|S|notice other effects not listed above, contact your doctor or||
2618|064|S|pharmacist.||
2618|065|S|   In the US -||
2618|066|S|   Call your doctor for medical advice about side effects. You||
2618|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2618|068|S|www.fda.gov/medwatch.||
2618|069|S|   In Canada - Call your doctor for medical advice about side||
2618|070|S|effects. You may report side effects to Health Canada at||
2618|071|S|1-866-234-2345.||
2618|072|B|||
2618|073|P|PRECAUTIONS:  Before taking xanomeline/trospium, tell your doctor||
2618|074|P|or pharmacist if you are allergic to xanomeline or trospium; or||
2618|075|P|if you have any other allergies. This product may contain||
2618|076|P|inactive ingredients, which can cause allergic reactions or other||
2618|077|P|problems. Talk to your pharmacist for more details.||
2618|078|P|   Before using this medication, tell your doctor or pharmacist||
2618|079|P|your medical history, especially of: problems emptying your||
2618|080|P|bladder (urinary retention, bladder outflow obstruction), liver||
2618|081|P|problems, kidney problems, glaucoma, stomach/intestinal problems||
2618|082|P|(such as blockage, constipation, ulcerative colitis), gallbladder||
2618|083|P|problems (such as gallstones), myasthenia gravis.||
2618|084|P|   This drug may make you dizzy or drowsy or cause blurred||
2618|085|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
2618|086|P|or drowsy. Do not drive, use machinery, or do anything that needs||
2618|087|P|alertness or clear vision until you can do it safely. Limit||
2618|088|P|alcoholic beverages. Talk to your doctor if you are using||
2618|089|P|marijuana (cannabis).||
2618|090|P|   This medication may make you sweat less, making you more||
2618|091|P|likely to get heat stroke. Avoid doing things that may cause you||
2618|092|P|to overheat, such as hard work or exercise in hot weather, or||
2618|093|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2618|094|P|and dress lightly. If you overheat, quickly look for a place to||
2618|095|P|cool down and rest. Get medical help right away if you have a||
2618|096|P|fever that does not go away, mental/mood changes, headache, or||
2618|097|P|dizziness.||
2618|098|P|   Before having surgery, tell your doctor or dentist about all||
2618|099|P|the products you use (including prescription drugs,||
2618|100|P|nonprescription drugs, and herbal products).||
2618|101|P|   Older adults may be more sensitive to the side effects of this||
2618|102|P|drug, especially constipation, dry mouth, drowsiness, confusion,||
2618|103|P|or trouble urinating. Drowsiness and confusion can increase the||
2618|104|P|risk of falling.||
2618|105|P|   During pregnancy, this medication should be used only when||
2618|106|P|clearly needed. Since untreated mental/mood problems (such as||
2618|107|P|schizophrenia) can be a serious condition, do not stop taking||
2618|108|P|this medication unless directed by your doctor. If you are||
2618|109|P|planning pregnancy, become pregnant, or think you may be||
2618|110|P|pregnant, discuss with your doctor right away the benefits and||
2618|111|P|risks of using this medication during pregnancy.||
2618|112|P|   It is unknown if this medication passes into breast milk.||
2618|113|P|Consult your doctor before breastfeeding.||
2618|114|B|||
2618|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2618|116|I|medications work or increase your risk for serious side effects.||
2618|117|I|This document does not contain all possible drug interactions.||
2618|118|I|Keep a list of all the products you use (including||
2618|119|I|prescription/nonprescription drugs and herbal products) and share||
2618|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
2618|121|I|the dosage of any medicines without your doctor's approval.||
2618|122|I|   Some products that may interact with this drug are: potassium||
2618|123|I|tablets/capsules, pramlintide.||
2618|124|I|   Tell your doctor or pharmacist if you are using other products||
2618|125|I|that cause drowsiness such as opioid pain or cough relievers||
2618|126|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
2618|127|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
2618|128|I|zolpidem), muscle relaxants (such as carisoprodol,||
2618|129|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2618|130|I|diphenhydramine).||
2618|131|I|   Check the labels on all your medicines (such as allergy or||
2618|132|I|cough-and-cold products) because they may contain ingredients||
2618|133|I|that cause drowsiness. Ask your pharmacist about using those||
2618|134|I|products safely.||
2618|135|B|||
2618|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2618|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2618|138|O|poison control center right away. US residents can call||
2618|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2618|140|O|Symptoms of overdose may include: seizure, fast heartbeat,||
2618|141|O|widened pupils.||
2618|142|B|||
2618|143|N|NOTES:  Do not share this medication with others.||
2618|144|N|   Lab and/or medical tests (such as liver function, EKG) should||
2618|145|N|be done before you start taking this medication and while you are||
2618|146|N|taking it. Keep all medical and lab appointments. Consult your||
2618|147|N|doctor for more details.||
2618|148|B|||
2618|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2618|150|D|remember. If it is near the time of the next dose, skip the||
2618|151|D|missed dose. Take your next dose at the regular time. Do not||
2618|152|D|double the dose to catch up.||
2618|153|B|||
2618|154|R|STORAGE:  Store at room temperature away from light and moisture.||
2618|155|R|Do not store in the bathroom. Keep all medications away from||
2618|156|R|children and pets.||
2618|157|R|   Do not flush medications down the toilet or pour them into a||
2618|158|R|drain unless instructed to do so. Properly discard this product||
2618|159|R|when it is expired or no longer needed. Consult your pharmacist||
2618|160|R|or local waste disposal company.||
2618|161|B|||
2618|162|A|Information last revised October 2024.||
2618|163|A|Copyright(c) 2025 First Databank, Inc.||
2618|164|B|||
2619|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2619|002|Z|does NOT have all possible information about this product. This||
2619|003|Z|information does not assure that this product is safe, effective,||
2619|004|Z|or appropriate for you. This information is not individual||
2619|005|Z|medical advice and does not substitute for the advice of your||
2619|006|Z|health care professional. Always ask your health care||
2619|007|Z|professional for complete information about this product and your||
2619|008|Z|specific health needs.||
2619|009|B|||
2619|010|T|SILDENAFIL FILM - ORAL||
2619|011|F|(sil-DEN-a-fil)||
2619|012|B|||
2619|013|U|USES:  Sildenafil is used to treat male sexual function problems||
2619|014|U|(impotence or erectile dysfunction-ED). In combination with||
2619|015|U|sexual stimulation, sildenafil works by increasing blood flow to||
2619|016|U|the penis to help a person get and keep an erection.||
2619|017|U|   This drug does not protect against sexually transmitted||
2619|018|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
2619|019|U|an effective barrier method (latex or polyurethane condom/dental||
2619|020|U|dams) during sexual activity will help to decrease your risk of||
2619|021|U|infection.||
2619|022|B|||
2619|023|V|OTHER USES:  This section contains uses of this drug that are not||
2619|024|V|listed in the approved professional labeling for the drug but||
2619|025|V|that may be prescribed by your health care professional. Use this||
2619|026|V|drug for a condition that is listed in this section only if it||
2619|027|V|has been so prescribed by your health care professional.||
2619|028|V|   Sildenafil is also available in other brands and strengths for||
2619|029|V|high blood pressure in the lungs (pulmonary hypertension).||
2619|030|B|||
2619|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2619|032|H|from your pharmacist before you start taking sildenafil and each||
2619|033|H|time you get a refill. If you have any questions, ask your doctor||
2619|034|H|or pharmacist.||
2619|035|H|   To treat erectile dysfunction-ED, take this medication by||
2619|036|H|mouth as directed by your doctor, usually as needed. Take||
2619|037|H|sildenafil with or without food at least 30 minutes, but no more||
2619|038|H|than 4 hours, before sexual activity (1 hour before works best).||
2619|039|H|This medication may take longer to start working if you take it||
2619|040|H|with a high-fat meal. Do not take more than once daily as needed.||
2619|041|H|   With dry hands, place the medication on top of the tongue and||
2619|042|H|let it dissolve. Allow it to dissolve completely, then swallow||
2619|043|H|with or without water. Swallow saliva normally as the medication||
2619|044|H|is dissolving. If your dose is for more than one film, let the||
2619|045|H|first film fully dissolve before using the second film.||
2619|046|H|   The dosage is based on your medical condition, response to||
2619|047|H|treatment, and other medications you may be taking. Be sure to||
2619|048|H|tell your doctor and pharmacist about all the products you use||
2619|049|H|(including prescription drugs, nonprescription drugs, and herbal||
2619|050|H|products).||
2619|051|H|   Tell your doctor if your condition does not get better.||
2619|052|B|||
2619|053|S|SIDE EFFECTS:  Dizziness, headache, flushing, or stomach upset||
2619|054|S|may occur. Vision changes such as increased sensitivity to light,||
2619|055|S|blurred vision, or trouble telling blue and green colors apart||
2619|056|S|may also occur. If any of these effects last or get worse, tell||
2619|057|S|your doctor or pharmacist promptly.||
2619|058|S|   To reduce the risk of dizziness and lightheadedness, get up||
2619|059|S|slowly when rising from a sitting or lying position.||
2619|060|S|   Remember that this medication has been prescribed because your||
2619|061|S|doctor has judged that the benefit to you is greater than the||
2619|062|S|risk of side effects. Many people using this medication do not||
2619|063|S|have serious side effects.||
2619|064|S|   Sexual activity may put extra strain on your heart, especially||
2619|065|S|if you have heart problems. If you have heart problems and||
2619|066|S|experience any of these serious side effects while having sex,||
2619|067|S|stop and get medical help right away: severe dizziness, fainting,||
2619|068|S|chest/jaw/left arm pain, nausea.||
2619|069|S|   Rarely, sudden decreased vision, or even permanent blindness,||
2619|070|S|may occur in one or both eyes (NAION). If this serious problem||
2619|071|S|occurs, stop taking sildenafil and get medical help right away.||
2619|072|S|You have a slightly greater chance of developing NAION if you||
2619|073|S|have heart disease, diabetes, high cholesterol, certain other eye||
2619|074|S|problems ("crowded disk"), high blood pressure, if you are over||
2619|075|S|50, or if you smoke.||
2619|076|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
2619|077|S|ringing in the ears and dizziness, may occur. Stop taking||
2619|078|S|sildenafil and get medical help right away if these effects||
2619|079|S|occur.||
2619|080|S|   Rarely, males may have a painful or prolonged erection lasting||
2619|081|S|4 or more hours. If this occurs, stop using this drug and get||
2619|082|S|medical help right away, or permanent problems could occur.||
2619|083|S|   A very serious allergic reaction to this drug is rare.||
2619|084|S|However, get medical help right away if you notice any symptoms||
2619|085|S|of a serious allergic reaction, including: rash, itching/swelling||
2619|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2619|087|S|breathing.||
2619|088|S|   This is not a complete list of possible side effects. If you||
2619|089|S|notice other effects not listed above, contact your doctor or||
2619|090|S|pharmacist.||
2619|091|S|   In the US -||
2619|092|S|   Call your doctor for medical advice about side effects. You||
2619|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2619|094|S|www.fda.gov/medwatch.||
2619|095|S|   In Canada - Call your doctor for medical advice about side||
2619|096|S|effects. You may report side effects to Health Canada at||
2619|097|S|1-866-234-2345.||
2619|098|B|||
2619|099|P|PRECAUTIONS:  Before taking sildenafil, tell your doctor or||
2619|100|P|pharmacist if you are allergic to it; or if you have any other||
2619|101|P|allergies. This product may contain inactive ingredients, which||
2619|102|P|can cause allergic reactions or other problems. Talk to your||
2619|103|P|pharmacist for more details.||
2619|104|P|   Before using this medication, tell your doctor or pharmacist||
2619|105|P|your medical history, especially of: heart problems (such as||
2619|106|P|heart attack or life-threatening irregular heartbeat in the past||
2619|107|P|6 months, chest pain/angina, heart failure), stroke in the past 6||
2619|108|P|months, kidney disease, liver disease, high or low blood||
2619|109|P|pressure, dehydration, penis conditions (such as angulation,||
2619|110|P|fibrosis/scarring, Peyronie's disease), history of||
2619|111|P|painful/prolonged erection (priapism), conditions that may||
2619|112|P|increase the risk of priapism (such as sickle cell anemia,||
2619|113|P|leukemia, multiple myeloma), eye problems (such as retinitis||
2619|114|P|pigmentosa, sudden decreased vision, NAION).||
2619|115|P|   This drug may make you dizzy or cause vision problems. Alcohol||
2619|116|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
2619|117|P|use machinery, or do anything that needs alertness or clear||
2619|118|P|vision until you can do it safely. Limit alcoholic beverages.||
2619|119|P|Talk to your doctor if you are using marijuana (cannabis).||
2619|120|P|   Before having surgery, tell your doctor or dentist about all||
2619|121|P|the products you use (including prescription drugs,||
2619|122|P|nonprescription drugs, and herbal products).||
2619|123|P|   This brand of sildenafil is not usually used by women. It is||
2619|124|P|unlikely to be used during pregnancy or breastfeeding. Consult||
2619|125|P|your doctor if you have any questions about this medication.||
2619|126|B|||
2619|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2619|128|I|medications work or increase your risk for serious side effects.||
2619|129|I|This document does not contain all possible drug interactions.||
2619|130|I|Keep a list of all the products you use (including||
2619|131|I|prescription/nonprescription drugs and herbal products) and share||
2619|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
2619|133|I|the dosage of any medicines without your doctor's approval.||
2619|134|I|   Some products that may interact with this drug are: riociguat,||
2619|135|I|vericiguat.||
2619|136|I|   Sildenafil can cause a serious drop in your blood pressure||
2619|137|I|when used with nitrates. A serious drop in blood pressure can||
2619|138|I|lead to dizziness, fainting, and rarely heart attack or stroke.||
2619|139|I|Do not use sildenafil with any of the following: certain drugs||
2619|140|I|used to treat chest pain/angina (nitrates such as nitroglycerin,||
2619|141|I|isosorbide), recreational drugs called "poppers" containing amyl||
2619|142|I|or butyl nitrite.||
2619|143|I|   If you are also taking an alpha blocker medication (such as||
2619|144|I|doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high||
2619|145|I|blood pressure, your blood pressure may get too low which can||
2619|146|I|lead to dizziness or fainting. Your doctor may start treatment||
2619|147|I|with a lower dose of sildenafil to minimize your risk of low||
2619|148|I|blood pressure.||
2619|149|I|   Other medications can affect the removal of sildenafil from||
2619|150|I|your body, which may affect how sildenafil works. Examples||
2619|151|I|include azole antifungals (such as itraconazole, ketoconazole),||
2619|152|I|macrolide antibiotics (such as clarithromycin, erythromycin),||
2619|153|I|mifepristone, rifampin, ritonavir, among others.||
2619|154|I|   Do not take this medication with any other product that||
2619|155|I|contains sildenafil or other similar medications for erectile||
2619|156|I|dysfunction-ED or pulmonary hypertension (such as tadalafil,||
2619|157|I|vardenafil).||
2619|158|B|||
2619|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2619|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2619|161|O|poison control center right away. US residents can call||
2619|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2619|163|O|Symptoms of overdose may include: severe dizziness, fainting,||
2619|164|O|painful/prolonged erection.||
2619|165|B|||
2619|166|N|NOTES:  Do not share this medication with others.||
2619|167|B|||
2619|168|D|MISSED DOSE:  Not applicable.||
2619|169|B|||
2619|170|R|STORAGE:  Store in the original package at room temperature away||
2619|171|R|from light and moisture. Do not store in the bathroom. Keep all||
2619|172|R|medications away from children and pets.||
2619|173|R|   Do not flush medications down the toilet or pour them into a||
2619|174|R|drain unless instructed to do so. Properly discard this product||
2619|175|R|when it is expired or no longer needed. Consult your pharmacist||
2619|176|R|or local waste disposal company.||
2619|177|B|||
2619|178|A|Information last revised October 2025.||
2619|179|A|Copyright(c) 2025 First Databank, Inc.||
2619|180|B|||
2620|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2620|002|Z|does NOT have all possible information about this product. This||
2620|003|Z|information does not assure that this product is safe, effective,||
2620|004|Z|or appropriate for you. This information is not individual||
2620|005|Z|medical advice and does not substitute for the advice of your||
2620|006|Z|health care professional. Always ask your health care||
2620|007|Z|professional for complete information about this product and your||
2620|008|Z|specific health needs.||
2620|009|B|||
2620|010|T|GLUTAMINE - ORAL||
2620|011|F|(GLOO-ta-meen)||
2620|012|B|||
2620|013|C|COMMON BRAND NAME(S): Endari||
2620|014|B|||
2620|015|U|USES:  Glutamine is used by people with sickle cell disease to||
2620|016|U|reduce the number of painful crises caused by the disease.||
2620|017|B|||
2620|018|H|HOW TO USE:  Read the Instructions for Use if available from your||
2620|019|H|pharmacist before you start taking glutamine and each time you||
2620|020|H|get a refill. If you have any questions, ask your doctor or||
2620|021|H|pharmacist.||
2620|022|H|   Take this medication by mouth as directed by your doctor,||
2620|023|H|usually twice daily. The dosage is based on your weight, medical||
2620|024|H|condition, and response to treatment. Open the packet and pour||
2620|025|H|the powder into 4 to 6 ounces (120 to 180 milliliters) of soft||
2620|026|H|food (such as applesauce, yogurt) or 8 ounces (240 milliliters)||
2620|027|H|of liquid (such as water, milk, apple juice) as directed. The||
2620|028|H|soft food or liquid should be cold or at room temperature. Do not||
2620|029|H|use hot food or liquid. Mix well (the powder may not fully||
2620|030|H|dissolve) and take the mixture right away.||
2620|031|H|   Use this medication regularly to get the most benefit from it.||
2620|032|H|To help you remember, take it at the same times each day.||
2620|033|H|   Do not increase your dose or use this drug more often or for||
2620|034|H|longer than prescribed. Your condition will not improve any||
2620|035|H|faster, and your risk of serious side effects will increase.||
2620|036|H|   Tell your doctor if your condition lasts or gets worse.||
2620|037|B|||
2620|038|S|SIDE EFFECTS:  Constipation, nausea, headache, stomach pain,||
2620|039|S|cough, or back pain may occur. If any of these effects last or||
2620|040|S|get worse, tell your doctor or pharmacist promptly.||
2620|041|S|   Remember that this medication has been prescribed because your||
2620|042|S|doctor has judged that the benefit to you is greater than the||
2620|043|S|risk of side effects. Many people using this medication do not||
2620|044|S|have serious side effects.||
2620|045|S|   A very serious allergic reaction to this drug is rare.||
2620|046|S|However, get medical help right away if you notice any symptoms||
2620|047|S|of a serious allergic reaction, including: rash, itching/swelling||
2620|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2620|049|S|breathing.||
2620|050|S|   This is not a complete list of possible side effects. If you||
2620|051|S|notice other effects not listed above, contact your doctor or||
2620|052|S|pharmacist.||
2620|053|S|   In the US -||
2620|054|S|   Call your doctor for medical advice about side effects. You||
2620|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2620|056|S|www.fda.gov/medwatch.||
2620|057|S|   In Canada - Call your doctor for medical advice about side||
2620|058|S|effects. You may report side effects to Health Canada at||
2620|059|S|1-866-234-2345.||
2620|060|B|||
2620|061|P|PRECAUTIONS:  Before taking glutamine, tell your doctor or||
2620|062|P|pharmacist if you are allergic to it; or if you have any other||
2620|063|P|allergies. This product may contain inactive ingredients, which||
2620|064|P|can cause allergic reactions or other problems. Talk to your||
2620|065|P|pharmacist for more details.||
2620|066|P|   Before using this medication, tell your doctor or pharmacist||
2620|067|P|your medical history.||
2620|068|P|   Before having surgery, tell your doctor or dentist about all||
2620|069|P|the products you use (including prescription drugs,||
2620|070|P|nonprescription drugs, and herbal products).||
2620|071|P|   During pregnancy, this medication should be used only when||
2620|072|P|clearly needed. Discuss the risks and benefits with your doctor.||
2620|073|P|   It is unknown if this medication passes into breast milk.||
2620|074|P|Consult your doctor before breastfeeding.||
2620|075|B|||
2620|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2620|077|I|medications work or increase your risk for serious side effects.||
2620|078|I|This document does not contain all possible drug interactions.||
2620|079|I|Keep a list of all the products you use (including||
2620|080|I|prescription/nonprescription drugs and herbal products) and share||
2620|081|I|it with your doctor and pharmacist. Do not start, stop, or change||
2620|082|I|the dosage of any medicines without your doctor's approval.||
2620|083|B|||
2620|084|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2620|085|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2620|086|O|poison control center right away. US residents can call||
2620|087|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2620|088|B|||
2620|089|N|NOTES:  Do not share this medication with others.||
2620|090|N|   Lab and/or medical tests (such as complete blood counts) may||
2620|091|N|be done while you are taking this medication. Keep all medical||
2620|092|N|and lab appointments. Consult your doctor for more details.||
2620|093|B|||
2620|094|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2620|095|D|remember. If it is near the time of the next dose, skip the||
2620|096|D|missed dose. Take your next dose at the regular time. Do not||
2620|097|D|double the dose to catch up.||
2620|098|B|||
2620|099|R|STORAGE:  Store at room temperature away from light and moisture.||
2620|100|R|Do not store in the bathroom. Keep all medications away from||
2620|101|R|children and pets.||
2620|102|R|   Do not flush medications down the toilet or pour them into a||
2620|103|R|drain unless instructed to do so. Properly discard this product||
2620|104|R|when it is expired or no longer needed. Consult your pharmacist||
2620|105|R|or local waste disposal company.||
2620|106|B|||
2620|107|A|Information last revised October 2024.||
2620|108|A|Copyright(c) 2025 First Databank, Inc.||
2620|109|B|||
2621|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2621|002|Z|does NOT have all possible information about this product. This||
2621|003|Z|information does not assure that this product is safe, effective,||
2621|004|Z|or appropriate for you. This information is not individual||
2621|005|Z|medical advice and does not substitute for the advice of your||
2621|006|Z|health care professional. Always ask your health care||
2621|007|Z|professional for complete information about this product and your||
2621|008|Z|specific health needs.||
2621|009|B|||
2621|010|T|ZOLBETUXIMAB - INJECTION||
2621|011|B|||
2621|012|C|COMMON BRAND NAME(S): Vyloy||
2621|013|B|||
2621|014|U|USES:  This medication is used to treat certain types of cancer||
2621|015|U|(such as stomach, esophageal). Zolbetuximab works by slowing or||
2621|016|U|stopping the growth of cancer cells.||
2621|017|B|||
2621|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2621|019|H|from your pharmacist before you start using zolbetuximab and each||
2621|020|H|time you get a treatment. If you have any questions, ask your||
2621|021|H|doctor or pharmacist.||
2621|022|H|   This medication is given by injection into a vein by a health||
2621|023|H|care professional. It is given as directed by your doctor,||
2621|024|H|usually once every 2 or 3 weeks. The dosage is based on your||
2621|025|H|medical condition and body size.||
2621|026|H|   Infusion reactions may happen during the infusion of this drug||
2621|027|H|and for some time afterward. Your doctor may prescribe other||
2621|028|H|medications (such as antihistamines) before each treatment to||
2621|029|H|help prevent these side effects. Tell your doctor right away if||
2621|030|H|you have any symptoms of infusion reactions such as nausea,||
2621|031|H|vomiting, abdominal pain, increased saliva, fever, chills, cough,||
2621|032|H|chest pain, back pain, or high blood pressure. Your doctor may||
2621|033|H|give you other medications to help with these side effects or may||
2621|034|H|slow down or stop your treatment for some time.||
2621|035|H|   Use this medication regularly to get the most benefit from it.||
2621|036|H|To help you remember, mark your calendar with a reminder.||
2621|037|B|||
2621|038|S|SIDE EFFECTS:  See also How to Use section.||
2621|039|S|   Nausea, vomiting, loss of appetite, weight loss, or swelling||
2621|040|S|hands/ankles/feet may occur. Nausea and vomiting can be severe.||
2621|041|S|In some cases, your doctor may prescribe medication to prevent or||
2621|042|S|relieve nausea and vomiting. Eating several small meals, not||
2621|043|S|eating before treatment, or limiting activity may help lessen||
2621|044|S|some of these effects. If any of these effects last or get worse,||
2621|045|S|tell your doctor or pharmacist promptly.||
2621|046|S|   Remember that this medication has been prescribed because your||
2621|047|S|doctor has judged that the benefit to you is greater than the||
2621|048|S|risk of side effects. Many people using this medication do not||
2621|049|S|have serious side effects.||
2621|050|S|   A very serious allergic reaction to this drug is rare.||
2621|051|S|However, get medical help right away if you notice any symptoms||
2621|052|S|of a serious allergic reaction, including: rash, itching/swelling||
2621|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2621|054|S|breathing.||
2621|055|S|   This is not a complete list of possible side effects. If you||
2621|056|S|notice other effects not listed above, contact your doctor or||
2621|057|S|pharmacist.||
2621|058|S|   In the US -||
2621|059|S|   Call your doctor for medical advice about side effects. You||
2621|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2621|061|S|www.fda.gov/medwatch.||
2621|062|S|   In Canada - Call your doctor for medical advice about side||
2621|063|S|effects. You may report side effects to Health Canada at||
2621|064|S|1-866-234-2345.||
2621|065|B|||
2621|066|P|PRECAUTIONS:  Before using zolbetuximab, tell your doctor or||
2621|067|P|pharmacist if you are allergic to it; or if you have any other||
2621|068|P|allergies. This product may contain inactive ingredients, which||
2621|069|P|can cause allergic reactions or other problems. Talk to your||
2621|070|P|pharmacist for more details.||
2621|071|P|   Before using this medication, tell your doctor or pharmacist||
2621|072|P|your medical history.||
2621|073|P|   Before having surgery, tell your doctor or dentist about all||
2621|074|P|the products you use (including prescription drugs,||
2621|075|P|nonprescription drugs, and herbal products).||
2621|076|P|   During pregnancy, this medication should be used only when||
2621|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
2621|078|P|   It is unknown if this medication passes into breast milk.||
2621|079|P|Because of the possible risk to the infant, breastfeeding is not||
2621|080|P|recommended while using this medication and for 8 months after||
2621|081|P|the last dose. Consult your doctor before breastfeeding.||
2621|082|B|||
2621|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2621|084|I|medications work or increase your risk for serious side effects.||
2621|085|I|This document does not contain all possible drug interactions.||
2621|086|I|Keep a list of all the products you use (including||
2621|087|I|prescription/nonprescription drugs and herbal products) and share||
2621|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
2621|089|I|the dosage of any medicines without your doctor's approval.||
2621|090|B|||
2621|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2621|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2621|093|O|poison control center right away. US residents can call||
2621|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2621|095|B|||
2621|096|N|NOTES:  Keep all medical and lab appointments.||
2621|097|B|||
2621|098|D|MISSED DOSE:  It is important to get each dose of this medication||
2621|099|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2621|100|D|right away for a new dosing schedule.||
2621|101|B|||
2621|102|R|STORAGE:  Not applicable. This medication is given in a hospital||
2621|103|R|or clinic and will not be stored at home.||
2621|104|B|||
2621|105|A|Information last revised October 2024.||
2621|106|A|Copyright(c) 2025 First Databank, Inc.||
2621|107|B|||
2622|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2622|002|Z|does NOT have all possible information about this product. This||
2622|003|Z|information does not assure that this product is safe, effective,||
2622|004|Z|or appropriate for you. This information is not individual||
2622|005|Z|medical advice and does not substitute for the advice of your||
2622|006|Z|health care professional. Always ask your health care||
2622|007|Z|professional for complete information about this product and your||
2622|008|Z|specific health needs.||
2622|009|B|||
2622|010|T|INAVOLISIB - ORAL||
2622|011|B|||
2622|012|C|COMMON BRAND NAME(S): Itovebi||
2622|013|B|||
2622|014|U|USES:  This medication is used to treat certain types of breast||
2622|015|U|cancer. Inavolisib belongs to a class of drugs known as kinase||
2622|016|U|inhibitors. It works by slowing or stopping the growth of cancer||
2622|017|U|cells.||
2622|018|B|||
2622|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2622|020|H|from your pharmacist before you start taking inavolisib and each||
2622|021|H|time you get a refill. If you have any questions, ask your doctor||
2622|022|H|or pharmacist.||
2622|023|H|   Take this medication by mouth with or without food as directed||
2622|024|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2622|025|H|not chew, crush, or split the tablets.||
2622|026|H|   The dosage is based on your medical condition and response to||
2622|027|H|treatment.||
2622|028|H|   Use this medication regularly to get the most benefit from it.||
2622|029|H|To help you remember, take it at the same time each day.||
2622|030|H|   If you vomit after taking a dose, do not take another dose on||
2622|031|H|the same day. Wait until the next day to take your dose at the||
2622|032|H|regular time.||
2622|033|H|   Do not increase your dose or use this drug more often or for||
2622|034|H|longer than prescribed. Your condition will not improve any||
2622|035|H|faster, and your risk of side effects will increase.||
2622|036|H|   Since this drug can be absorbed through the skin and lungs and||
2622|037|H|may harm an unborn baby, women who are pregnant or who may become||
2622|038|H|pregnant should not handle this medication or breathe the dust||
2622|039|H|from the tablets.||
2622|040|B|||
2622|041|S|SIDE EFFECTS:  Nausea, vomiting, mouth pain/sores, loss of||
2622|042|S|appetite, decreased weight, or dry skin may occur. If any of||
2622|043|S|these effects last or get worse, tell your doctor or pharmacist||
2622|044|S|promptly.||
2622|045|S|   Diarrhea commonly occurs. Severe diarrhea can lead to||
2622|046|S|dehydration and kidney problems. If you have diarrhea, tell your||
2622|047|S|doctor right away. Drink enough fluids to prevent dehydration and||
2622|048|S|ask your doctor or pharmacist about medicines to treat diarrhea.||
2622|049|S|   Pain or sores in the mouth and throat may occur. Brush your||
2622|050|S|teeth carefully/gently, avoid using mouthwash that contains||
2622|051|S|alcohol, and rinse your mouth often with cool water mixed with||
2622|052|S|baking soda or salt. It may also be best to eat soft, moist||
2622|053|S|foods.||
2622|054|S|   Temporary hair loss may occur. Normal hair growth should||
2622|055|S|return after treatment has ended.||
2622|056|S|   People using this medication may have serious side effects.||
2622|057|S|However, you have been prescribed this drug because your doctor||
2622|058|S|has judged that the benefit to you is greater than the risk of||
2622|059|S|side effects. Careful monitoring by your doctor may decrease your||
2622|060|S|risk.||
2622|061|S|   Tell your doctor right away if you have any serious side||
2622|062|S|effects, including: easy bruising/bleeding, unusual tiredness,||
2622|063|S|signs of infection (such as sore throat that doesn't go away,||
2622|064|S|fever, chills, burning/painful urination), stomach/abdominal||
2622|065|S|pain, black/bloody stool.||
2622|066|S|   This medication may make your blood sugar rise, which can||
2622|067|S|cause or worsen diabetes. Tell your doctor right away if you have||
2622|068|S|symptoms of high blood sugar, such as increased thirst/urination.||
2622|069|S|If you already have diabetes, check your blood sugar regularly as||
2622|070|S|directed and share the results with your doctor. Your doctor may||
2622|071|S|need to adjust your diabetes medication, exercise program, or||
2622|072|S|diet.||
2622|073|S|   Inavolisib can commonly cause a rash that is usually not||
2622|074|S|serious. However, you may not be able to tell it apart from a||
2622|075|S|rare rash that could be a sign of a severe reaction. Get medical||
2622|076|S|help right away if you develop any rash.||
2622|077|S|   A very serious allergic reaction to this drug is rare.||
2622|078|S|However, get medical help right away if you notice any symptoms||
2622|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2622|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2622|081|S|breathing.||
2622|082|S|   This is not a complete list of possible side effects. If you||
2622|083|S|notice any other effects not listed above, contact your doctor or||
2622|084|S|pharmacist.||
2622|085|S|   In the US -||
2622|086|S|   Call your doctor for medical advice about side effects. You||
2622|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2622|088|S|www.fda.gov/medwatch.||
2622|089|S|   In Canada - Call your doctor for medical advice about side||
2622|090|S|effects. You may report side effects to Health Canada at||
2622|091|S|1-866-234-2345.||
2622|092|B|||
2622|093|P|PRECAUTIONS:  Before taking inavolisib, tell your doctor or||
2622|094|P|pharmacist if you are allergic to it; or if you have any other||
2622|095|P|allergies. This product may contain inactive ingredients, which||
2622|096|P|can cause allergic reactions or other problems. Talk to your||
2622|097|P|pharmacist for more details.||
2622|098|P|   Before using this medication, tell your doctor or pharmacist||
2622|099|P|your medical history, especially of: diabetes, kidney disease.||
2622|100|P|   Before having surgery, tell your doctor or dentist about all||
2622|101|P|the products you use (including prescription drugs,||
2622|102|P|nonprescription drugs, and herbal products).||
2622|103|P|   Older adults may be more sensitive to the side effects of this||
2622|104|P|drug.||
2622|105|P|   Since this drug can be absorbed through the skin and lungs and||
2622|106|P|may harm an unborn baby, women who are pregnant or who may become||
2622|107|P|pregnant should not handle this medication or breathe the dust||
2622|108|P|from the tablets.||
2622|109|P|   Tell your doctor if you are pregnant or plan to become||
2622|110|P|pregnant. You should not become pregnant while using inavolisib.||
2622|111|P|Inavolisib may harm an unborn baby. Your doctor should order a||
2622|112|P|pregnancy test before you start this medication. Women using this||
2622|113|P|medication should ask about reliable forms of non-hormonal birth||
2622|114|P|control during treatment and for 1 week after the last dose. Men||
2622|115|P|using this medication should ask about reliable forms of birth||
2622|116|P|control during treatment and for 1 week after the last dose. If||
2622|117|P|you or your partner becomes pregnant, talk to your doctor right||
2622|118|P|away about the risks and benefits of this medication.||
2622|119|P|   It is unknown if this medication passes into breast milk.||
2622|120|P|Because of the possible risk to the infant, breastfeeding is not||
2622|121|P|recommended while using this medication and for 1 week after the||
2622|122|P|last dose. Consult your doctor before breastfeeding.||
2622|123|B|||
2622|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2622|125|I|medications work or increase your risk for serious side effects.||
2622|126|I|This document does not contain all possible drug interactions.||
2622|127|I|Keep a list of all the products you use (including||
2622|128|I|prescription/nonprescription drugs and herbal products) and share||
2622|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
2622|130|I|the dosage of any medicines without your doctor's approval.||
2622|131|B|||
2622|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2622|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2622|134|O|poison control center right away. US residents can call||
2622|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2622|136|B|||
2622|137|N|NOTES:  Do not share this medication with others.||
2622|138|N|   Lab and/or medical tests (such as complete blood count, blood||
2622|139|N|sugar, blood mineral levels, kidney/liver function) should be||
2622|140|N|done before you start taking this medication and while you are||
2622|141|N|taking it. Keep all medical and lab appointments.||
2622|142|B|||
2622|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2622|144|D|remember. If it is more than 9 hours after the missed dose, skip||
2622|145|D|the missed dose. Take your next dose at the regular time. Do not||
2622|146|D|double the dose to catch up.||
2622|147|B|||
2622|148|R|STORAGE:  Store at room temperature away from light and moisture.||
2622|149|R|Do not store in the bathroom. Keep all medications away from||
2622|150|R|children and pets.||
2622|151|R|   Do not flush medications down the toilet or pour them into a||
2622|152|R|drain unless instructed to do so. Properly discard this product||
2622|153|R|when it is expired or no longer needed. Consult your pharmacist||
2622|154|R|or local waste disposal company.||
2622|155|B|||
2622|156|A|Information last revised November 2024.||
2622|157|A|Copyright(c) 2025 First Databank, Inc.||
2622|158|B|||
2623|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2623|002|Z|does NOT have all possible information about this product. This||
2623|003|Z|information does not assure that this product is safe, effective,||
2623|004|Z|or appropriate for you. This information is not individual||
2623|005|Z|medical advice and does not substitute for the advice of your||
2623|006|Z|health care professional. Always ask your health care||
2623|007|Z|professional for complete information about this product and your||
2623|008|Z|specific health needs.||
2623|009|B|||
2623|010|T|OBECABTAGENE AUTOLEUCEL - INJECTION||
2623|011|B|||
2623|012|C|COMMON BRAND NAME(S): Aucatzyl||
2623|013|B|||
2623|014|W|WARNING:  This product may cause a serious (even fatal) reaction||
2623|015|W|called cytokine release syndrome-CRS. Careful monitoring and||
2623|016|W|prompt treatment may decrease your risk. Before treatment with||
2623|017|W|this product, tell your doctor your medical history, especially||
2623|018|W|of any current/recent infection. Tell your doctor right away if||
2623|019|W|you have any symptoms of CRS such as fever, chills/shaking||
2623|020|W|chills, fast/irregular heartbeat, shortness of breath, severe||
2623|021|W|nausea/vomiting/diarrhea, severe headache, low blood pressure, or||
2623|022|W|dizziness/lightheadedness.||
2623|023|W|   Serious nerve problems can occur after treatment with||
2623|024|W|obecabtagene autoleucel. Tell your doctor right away if you have||
2623|025|W|drowsiness, seizures, mental/mood changes (such as confusion,||
2623|026|W|anxiety, memory loss), or trouble with reading, writing,||
2623|027|W|speaking, or understanding.||
2623|028|W|   Although obecabtagene autoleucel is used to treat cancer, it||
2623|029|W|may rarely increase your risk of developing other cancers. Tell||
2623|030|W|your doctor right away if you have symptoms such as unusual||
2623|031|W|growths/lumps or swollen lymph nodes.||
2623|032|B|||
2623|033|U|USES:  Obecabtagene autoleucel is used to treat a certain type of||
2623|034|U|cancer (acute lymphoblastic leukemia - ALL) that has not gotten||
2623|035|U|better or that has come back after other kinds of treatment. This||
2623|036|U|type of treatment is known as gene therapy. Obecabtagene||
2623|037|U|autoleucel is made from your own white blood cells and is given||
2623|038|U|only to you. The white blood cells have been changed to have a||
2623|039|U|specific protein that helps your body slow or stop the growth of||
2623|040|U|certain cancer cells.||
2623|041|B|||
2623|042|H|HOW TO USE:  Read the Medication Guide provided by your health||
2623|043|H|care professional before you start using this product. If you||
2623|044|H|have any questions, ask your health care professional.||
2623|045|H|   Your doctor may give you 4 days of chemotherapy before||
2623|046|H|treatment with this product to prepare your body.||
2623|047|H|   This product is given by injection into a vein by a health||
2623|048|H|care professional. It is given as directed by your doctor,||
2623|049|H|usually in 2 doses given about 10 days apart. The dosage is based||
2623|050|H|on your medical condition.||
2623|051|H|   Your doctor will check you daily for at least 14 days after||
2623|052|H|your treatment to see how well it works and help you manage any||
2623|053|H|side effects. You should plan to stay near the place of your||
2623|054|H|treatment for at least 4 weeks after your treatment (for example,||
2623|055|H|within 2 hours' drive).||
2623|056|B|||
2623|057|S|SIDE EFFECTS:  See also Warning section.||
2623|058|S|   Nausea, vomiting, diarrhea, headache, muscle/joint pain, or||
2623|059|S|tiredness may occur. If any of these effects last or get worse,||
2623|060|S|tell your doctor or pharmacist promptly.||
2623|061|S|   People using this medication may have serious side effects.||
2623|062|S|However, you have been prescribed this drug because your doctor||
2623|063|S|has judged that the benefit to you is greater than the risk of||
2623|064|S|side effects. Careful monitoring by your doctor may decrease your||
2623|065|S|risk.||
2623|066|S|   Obecabtagene autoleucel may cause a severe decrease in your||
2623|067|S|blood cells and antibodies, which lowers your ability to fight||
2623|068|S|infections and increases the risk of anemia/bleeding problems.||
2623|069|S|You may be more likely to get a serious (rarely fatal) infection||
2623|070|S|and any infection you have may get worse. Tell your doctor right||
2623|071|S|away if you have signs of infection (such as sore throat that||
2623|072|S|doesn't go away, fever, chills), easy or unusual||
2623|073|S|bruising/bleeding, or unusual tiredness.||
2623|074|S|   A very serious allergic reaction to this drug is rare.||
2623|075|S|However, get medical help right away if you notice any symptoms||
2623|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2623|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2623|078|S|breathing.||
2623|079|S|   This is not a complete list of possible side effects. If you||
2623|080|S|notice other effects not listed above, contact your doctor or||
2623|081|S|pharmacist.||
2623|082|S|   In the US -||
2623|083|S|   Call your doctor for medical advice about side effects. You||
2623|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2623|085|S|www.fda.gov/medwatch.||
2623|086|S|   In Canada - Call your doctor for medical advice about side||
2623|087|S|effects. You may report side effects to Health Canada at||
2623|088|S|1-866-234-2345.||
2623|089|B|||
2623|090|P|PRECAUTIONS:  Before receiving obecabtagene autoleucel, tell your||
2623|091|P|doctor or pharmacist if you have any allergies. This product may||
2623|092|P|contain inactive ingredients, which can cause allergic reactions||
2623|093|P|or other problems. Talk to your pharmacist for more details.||
2623|094|P|   Before using this product, tell your doctor or pharmacist your||
2623|095|P|medical history, especially of: heart problems, lung/breathing||
2623|096|P|problems, nerve problems (such as memory loss, seizures),||
2623|097|P|past/current/recent infection.||
2623|098|P|   This product can make you more likely to get infections or may||
2623|099|P|make current infections worse. Stay away from anyone who has an||
2623|100|P|infection that may easily spread (such as chickenpox, COVID-19,||
2623|101|P|measles, flu). Talk to your doctor if you have been exposed to an||
2623|102|P|infection or for more details.||
2623|103|P|   Tell your health care professional that you are using||
2623|104|P|obecabtagene autoleucel before having any||
2623|105|P|immunizations/vaccinations. Avoid contact with people who have||
2623|106|P|recently received live vaccines (such as flu vaccine inhaled||
2623|107|P|through the nose).||
2623|108|P|   To lower the chance of getting cut, bruised, or injured, use||
2623|109|P|caution with sharp objects like razors and nail cutters, and||
2623|110|P|avoid activities such as contact sports.||
2623|111|P|   This product may make you drowsy or dizzy, affect your||
2623|112|P|coordination, or make it harder for you to think clearly. Alcohol||
2623|113|P|or marijuana (cannabis) can worsen these effects. Do not drive,||
2623|114|P|use machinery, or do anything that needs alertness until you can||
2623|115|P|do it safely (at least 8 weeks after receiving treatment is||
2623|116|P|recommended by the manufacturer). Limit alcoholic beverages. Talk||
2623|117|P|to your doctor if you are using marijuana (cannabis).||
2623|118|P|   Before having surgery, tell your doctor or dentist about all||
2623|119|P|the products you use (including prescription drugs,||
2623|120|P|nonprescription drugs, and herbal products).||
2623|121|P|   Tell your doctor if you are pregnant or plan to become||
2623|122|P|pregnant. You should not become pregnant while using this||
2623|123|P|product. Obecabtagene autoleucel may harm an unborn baby. Your||
2623|124|P|doctor should order a pregnancy test before you start this||
2623|125|P|product. If you become pregnant, talk to your doctor right away||
2623|126|P|about the risks and benefits of this product.||
2623|127|P|   It is unknown if this product passes into breast milk. Consult||
2623|128|P|your doctor before breastfeeding.||
2623|129|B|||
2623|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2623|131|I|medications work or increase your risk for serious side effects.||
2623|132|I|This document does not contain all possible drug interactions.||
2623|133|I|Keep a list of all the products you use (including||
2623|134|I|prescription/nonprescription drugs and herbal products) and share||
2623|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
2623|136|I|the dosage of any medicines without your doctor's approval.||
2623|137|B|||
2623|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2623|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2623|140|O|poison control center right away. US residents can call||
2623|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2623|142|B|||
2623|143|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2623|144|N|antibody levels) should be done before and after you receive this||
2623|145|N|product. Keep all medical and lab appointments.||
2623|146|N|   After receiving this treatment, do not donate blood, organs,||
2623|147|N|tissues, or cells.||
2623|148|B|||
2623|149|D|MISSED DOSE:  It is important to get each dose of this product as||
2623|150|D|scheduled. If you miss a dose, ask your doctor or pharmacist||
2623|151|D|right away for a new dosing schedule.||
2623|152|B|||
2623|153|R|STORAGE:  Not applicable. This product is given in a hospital or||
2623|154|R|clinic and will not be stored at home.||
2623|155|B|||
2623|156|M|MEDICAL ALERT:  Your condition can cause complications in a||
2623|157|M|medical emergency. For information about enrolling in MedicAlert,||
2623|158|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2623|159|B|||
2623|160|A|Information last revised May 2025.||
2623|161|A|Copyright(c) 2025 First Databank, Inc.||
2623|162|B|||
2624|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2624|002|Z|does NOT have all possible information about this product. This||
2624|003|Z|information does not assure that this product is safe, effective,||
2624|004|Z|or appropriate for you. This information is not individual||
2624|005|Z|medical advice and does not substitute for the advice of your||
2624|006|Z|health care professional. Always ask your health care||
2624|007|Z|professional for complete information about this product and your||
2624|008|Z|specific health needs.||
2624|009|B|||
2624|010|T|MARSTACIMAB - INJECTION||
2624|011|F|(mar-STAK-i-mab)||
2624|012|B|||
2624|013|C|COMMON BRAND NAME(S): Hympavzi||
2624|014|B|||
2624|015|U|USES:  This medication is used by people with a certain inherited||
2624|016|U|bleeding problem (hemophilia A or B) to help prevent or lessen||
2624|017|U|how often you have bleeding problems. Marstacimab belongs to a||
2624|018|U|class of medications known as monoclonal antibodies. It works by||
2624|019|U|helping your blood to clot normally, which helps prevent bleeding||
2624|020|U|due to hemophilia.||
2624|021|B|||
2624|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
2624|023|H|Instructions for Use if available from your pharmacist before you||
2624|024|H|start using this medication and each time you get a refill. Ask||
2624|025|H|your health care professional how to prepare and use this||
2624|026|H|medication. If you have any questions, ask your doctor or||
2624|027|H|pharmacist.||
2624|028|H|   Inject this medication under the skin as directed by your||
2624|029|H|doctor, usually once a week. The injection is given in the||
2624|030|H|thighs, or abdomen (at least 2 inches from your belly button). It||
2624|031|H|may also be given by a health care professional in the upper arm||
2624|032|H|(prefilled syringe only), or buttocks (prefilled pen only). The||
2624|033|H|dosage is based on your medical condition, weight, and response||
2624|034|H|to treatment.||
2624|035|H|   You may also require Factor VIII or Factor IX products to||
2624|036|H|treat breakthrough bleeds while using marstacimab. Ask your||
2624|037|H|healthcare professional for more information about the use of||
2624|038|H|these other products and what to do if you have breakthrough||
2624|039|H|bleeding.||
2624|040|H|   Take the medication out of the refrigerator 15 to 30 minutes||
2624|041|H|before you inject it to allow it to reach room temperature. Do||
2624|042|H|not warm up this medication any other way (for example, do not||
2624|043|H|heat it in the microwave, place it in hot water, or leave it in||
2624|044|H|direct sunlight). Do not shake the medication. Before using,||
2624|045|H|check this product for cloudiness, particles, or discoloration.||
2624|046|H|If you see any of these things, do not use the liquid. Before||
2624|047|H|injecting each dose, clean the skin you are going to inject into||
2624|048|H|(the injection site) with rubbing alcohol. Change the injection||
2624|049|H|site each time to lessen injury under the skin. Do not inject||
2624|050|H|into scars, stretch marks, or skin that is tender, bruised, red,||
2624|051|H|or hard. To lessen bruising, do not rub the injection site after||
2624|052|H|a shot. Learn how to store and discard medical supplies safely.||
2624|053|H|   Use this medication regularly to get the most benefit from it.||
2624|054|H|To help you remember, use it on the same day each week. Mark your||
2624|055|H|calendar with a reminder.||
2624|056|H|   Tell your doctor if your condition does not get better or if||
2624|057|H|it gets worse.||
2624|058|B|||
2624|059|S|SIDE EFFECTS:  Redness, itching, swelling, hardening, bruising,||
2624|060|S|or pain at the injection site may occur. Headache may also occur.||
2624|061|S|If any of these effects last or get worse, tell your doctor or||
2624|062|S|pharmacist promptly.||
2624|063|S|   Remember that this medication has been prescribed because your||
2624|064|S|doctor has judged that the benefit to you is greater than the||
2624|065|S|risk of side effects. Many people using this medication do not||
2624|066|S|have serious side effects.||
2624|067|S|   This medication may rarely cause serious (sometimes fatal)||
2624|068|S|problems from blood clots (such as pulmonary embolism, stroke,||
2624|069|S|heart attack, deep vein thrombosis). You may be at increased risk||
2624|070|S|for blood clots if you are also using other products (such as||
2624|071|S|Factor VIII or IX). Get medical help right away if you develop||
2624|072|S|symptoms of serious blood clots, such as shortness of||
2624|073|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
2624|074|S|sweating, confusion, sudden dizziness/fainting,||
2624|075|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2624|076|S|trouble speaking, weakness on one side of the body, sudden vision||
2624|077|S|changes.||
2624|078|S|   A very serious allergic reaction to this drug is rare.||
2624|079|S|However, get medical help right away if you notice any symptoms||
2624|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2624|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2624|082|S|breathing.||
2624|083|S|   This is not a complete list of possible side effects. If you||
2624|084|S|notice other effects not listed above, contact your doctor or||
2624|085|S|pharmacist.||
2624|086|S|   In the US -||
2624|087|S|   Call your doctor for medical advice about side effects. You||
2624|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2624|089|S|www.fda.gov/medwatch.||
2624|090|S|   In Canada - Call your doctor for medical advice about side||
2624|091|S|effects. You may report side effects to Health Canada at||
2624|092|S|1-866-234-2345.||
2624|093|B|||
2624|094|P|PRECAUTIONS:  Before using marstacimab, tell your doctor or||
2624|095|P|pharmacist if you are allergic to it; or if you have any other||
2624|096|P|allergies. This product may contain inactive ingredients, which||
2624|097|P|can cause allergic reactions or other problems. Talk to your||
2624|098|P|pharmacist for more details.||
2624|099|P|   Before using this medication, tell your doctor or pharmacist||
2624|100|P|your medical history, especially of: recent infection, recent||
2624|101|P|injury.||
2624|102|P|   Before having surgery, tell your doctor or dentist about all||
2624|103|P|the products you use (including prescription drugs,||
2624|104|P|nonprescription drugs, and herbal products). Your doctor or||
2624|105|P|dentist may tell you to stop using marstacimab before your||
2624|106|P|surgery. Ask for specific instructions about stopping or starting||
2624|107|P|this medication.||
2624|108|P|   Tell your doctor if you are pregnant or plan to become||
2624|109|P|pregnant. You should not become pregnant while using marstacimab.||
2624|110|P|Marstacimab may harm an unborn baby. Your doctor should order a||
2624|111|P|pregnancy test before you start this medication. Ask about||
2624|112|P|reliable forms of birth control while using this medication and||
2624|113|P|for 2 months after the last dose. If you become pregnant, talk to||
2624|114|P|your doctor right away about the risks and benefits of this||
2624|115|P|medication.||
2624|116|P|   It is unknown if this medication passes into breast milk.||
2624|117|P|Consult your doctor before breastfeeding.||
2624|118|B|||
2624|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2624|120|I|medications work or increase your risk for serious side effects.||
2624|121|I|This document does not contain all possible drug interactions.||
2624|122|I|Keep a list of all the products you use (including||
2624|123|I|prescription/nonprescription drugs and herbal products) and share||
2624|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
2624|125|I|the dosage of any medicines without your doctor's approval.||
2624|126|B|||
2624|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2624|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2624|129|O|poison control center right away. US residents can call||
2624|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2624|131|B|||
2624|132|N|NOTES:  Do not share this medication with others.||
2624|133|N|   Lab and/or medical tests (such as blood clotting tests) must||
2624|134|N|be done while you are using this medication. Keep all medical and||
2624|135|N|lab appointments.||
2624|136|B|||
2624|137|D|MISSED DOSE:  It is important to get each dose of this medication||
2624|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2624|139|D|right away for a new dosing schedule. Do not double the dose to||
2624|140|D|catch up.||
2624|141|B|||
2624|142|R|STORAGE:  Store in the refrigerator. Do not shake or freeze. Keep||
2624|143|R|the medication in the original package to protect it from light.||
2624|144|R|This medication may also be stored at room temperature if needed.||
2624|145|R|If the medication is stored at room temperature, do not put it||
2624|146|R|back in the refrigerator and discard after 7 days. Keep all||
2624|147|R|medications away from children and pets.||
2624|148|R|   Do not flush medications down the toilet or pour them into a||
2624|149|R|drain unless instructed to do so. Properly discard this product||
2624|150|R|when it is expired or no longer needed. Consult your pharmacist||
2624|151|R|or local waste disposal company.||
2624|152|B|||
2624|153|M|MEDICAL ALERT:  Your condition can cause complications in a||
2624|154|M|medical emergency. For information about enrolling in MedicAlert,||
2624|155|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2624|156|B|||
2624|157|A|Information last revised November 2024.||
2624|158|A|Copyright(c) 2025 First Databank, Inc.||
2624|159|B|||
2625|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2625|002|Z|does NOT have all possible information about this product. This||
2625|003|Z|information does not assure that this product is safe, effective,||
2625|004|Z|or appropriate for you. This information is not individual||
2625|005|Z|medical advice and does not substitute for the advice of your||
2625|006|Z|health care professional. Always ask your health care||
2625|007|Z|professional for complete information about this product and your||
2625|008|Z|specific health needs.||
2625|009|B|||
2625|010|T|RABIES VACCINE - INJECTION||
2625|011|F|(RAY-beez)||
2625|012|B|||
2625|013|C|COMMON BRAND NAME(S): Imovax, Rabavert||
2625|014|B|||
2625|015|U|USES:  This vaccine is used to help prevent rabies in people who||
2625|016|U|are at a higher risk of exposure to the virus (such as||
2625|017|U|veterinarians, lab workers who handle the virus). It may also be||
2625|018|U|used along with other treatments by people to prevent getting the||
2625|019|U|infection after being exposed to the virus (for example, from||
2625|020|U|being wounded by an infected animal). This vaccine works by||
2625|021|U|increasing the body's natural defense (immunity) against the||
2625|022|U|virus.||
2625|023|U|   Vaccines may not fully protect everyone who receives them.||
2625|024|B|||
2625|025|H|HOW TO USE:  Read all vaccine information available from your||
2625|026|H|health care professional before receiving the vaccine. If you||
2625|027|H|have any questions, ask your health care professional.||
2625|028|H|   This vaccine is given by injection into a muscle by a health||
2625|029|H|care professional. It is usually given in the upper arm. For||
2625|030|H|young children, it is usually given in the upper thigh.||
2625|031|H|   Vaccines are usually given in a series of doses to provide the||
2625|032|H|best protection. Closely follow the vaccination schedule provided||
2625|033|H|by your health care professional. Keep all scheduled medical||
2625|034|H|appointments. To help you remember, mark your calendar with a||
2625|035|H|reminder.||
2625|036|B|||
2625|037|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
2625|038|S|fever, muscle ache, joint pain, headache, tiredness, nausea, or||
2625|039|S|vomiting may occur. If any of these effects last or get worse,||
2625|040|S|tell your health care professional promptly.||
2625|041|S|   Rarely, some people have symptoms such as fainting, dizziness,||
2625|042|S|vision changes, or ringing in the ears just after getting a||
2625|043|S|vaccine injection. Tell your health care professional right away||
2625|044|S|if you have any of these symptoms. Sitting or lying down may||
2625|045|S|help, since these symptoms usually don't last long.||
2625|046|S|   Remember that this medication has been prescribed because your||
2625|047|S|health care professional has judged that the benefit to you is||
2625|048|S|greater than the risk of side effects. Many people using this||
2625|049|S|medication do not have serious side effects.||
2625|050|S|   A very serious allergic reaction to this drug is rare.||
2625|051|S|However, get medical help right away if you notice any symptoms||
2625|052|S|of a serious allergic reaction, including: rash, itching/swelling||
2625|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2625|054|S|breathing.||
2625|055|S|   This is not a complete list of possible side effects. If you||
2625|056|S|notice other effects not listed above, contact your health care||
2625|057|S|professional.||
2625|058|S|   Contact the doctor for medical advice about side effects. The||
2625|059|S|following numbers do not provide medical advice, but in the US||
2625|060|S|you may report side effects to the Vaccine Adverse Event||
2625|061|S|Reporting System (VAERS) at 1-800-822-7967. In Canada, you may||
2625|062|S|call the Vaccine Safety Section at Public Health Agency of Canada||
2625|063|S|at 1-866-844-0018.||
2625|064|B|||
2625|065|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
2625|066|P|care professional if you are allergic to it; or if you have any||
2625|067|P|other allergies. This product may contain inactive ingredients,||
2625|068|P|which can cause allergic reactions or other problems. Talk to||
2625|069|P|your health care professional for more details.||
2625|070|P|   Before receiving this vaccination, tell your health care||
2625|071|P|professional your medical history, especially of: current||
2625|072|P|fever/illness, immune system disorders (such as due to HIV||
2625|073|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
2625|074|P|radiation treatment).||
2625|075|P|   During pregnancy, this vaccine should be received only when||
2625|076|P|clearly needed. Discuss the risks and benefits with your health||
2625|077|P|care professional.||
2625|078|P|   It is unknown if this vaccine passes into breast milk. Consult||
2625|079|P|your health care professional before breastfeeding.||
2625|080|B|||
2625|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2625|082|I|medications work or increase your risk for serious side effects.||
2625|083|I|This document does not contain all possible drug interactions.||
2625|084|I|Keep a list of all the products you use (including||
2625|085|I|prescription/nonprescription drugs and herbal products) and share||
2625|086|I|it with your health care professional. Do not start, stop, or||
2625|087|I|change the dosage of any medicines without your doctor's||
2625|088|I|approval.||
2625|089|I|   Some products that may interact with this vaccine are: drugs||
2625|090|I|that weaken the immune system (including cyclosporine,||
2625|091|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
2625|092|I|prednisone).||
2625|093|B|||
2625|094|O|OVERDOSE:  Not applicable.||
2625|095|B|||
2625|096|N|NOTES:  Keep all medical and lab appointments.||
2625|097|B|||
2625|098|D|MISSED DOSE:  It is important that you get each vaccination as||
2625|099|D|scheduled. Ask when you should get each dose and mark your||
2625|100|D|calendar with a reminder.||
2625|101|B|||
2625|102|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
2625|103|R|medications away from children and pets.||
2625|104|R|   Do not flush medications down the toilet or pour them into a||
2625|105|R|drain unless instructed to do so. Properly discard this product||
2625|106|R|when it is expired or no longer needed. Consult your pharmacist||
2625|107|R|or local waste disposal company.||
2625|108|B|||
2625|109|A|Information last revised February 2025.||
2625|110|A|Copyright(c) 2025 First Databank, Inc.||
2625|111|B|||
2626|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2626|002|Z|does NOT have all possible information about this product. This||
2626|003|Z|information does not assure that this product is safe, effective,||
2626|004|Z|or appropriate for you. This information is not individual||
2626|005|Z|medical advice and does not substitute for the advice of your||
2626|006|Z|health care professional. Always ask your health care||
2626|007|Z|professional for complete information about this product and your||
2626|008|Z|specific health needs.||
2626|009|B|||
2626|010|T|MINOCYCLINE 40 MG EXTENDED-RELEASE - ORAL||
2626|011|F|(MIN-oh-SYE-kleen)||
2626|012|B|||
2626|013|C|COMMON BRAND NAME(S): Emrosi||
2626|014|B|||
2626|015|U|USES:  This medication is used to treat a certain type of skin||
2626|016|U|condition called rosacea. It helps to reduce the number of||
2626|017|U|pimples and bumps on the face.||
2626|018|U|   Although minocycline belongs to the class of antibiotics known||
2626|019|U|as tetracyclines, it is not known if this product works as an||
2626|020|U|antibiotic. Do not use this product to treat any infection,||
2626|021|U|including viral infections (such as the common cold, flu). Use||
2626|022|U|this medication only as prescribed by your doctor.||
2626|023|B|||
2626|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2626|025|H|from your pharmacist before you start taking minocycline and each||
2626|026|H|time you get a refill. If you have any questions, ask your doctor||
2626|027|H|or pharmacist.||
2626|028|H|   Take this medication by mouth with or without food as directed||
2626|029|H|by your doctor, usually once a day. Swallow the capsules whole.||
2626|030|H|Do not crush or chew the capsules. Doing so can release all of||
2626|031|H|the drug at once, increasing the risk of side effects.||
2626|032|H|   Take this medication with a full glass of water (8 ounces/240||
2626|033|H|milliliters) unless your doctor directs you otherwise. Do not lie||
2626|034|H|down for at least 10 minutes after taking this medication. You||
2626|035|H|may take this medication with food to lessen the chance of||
2626|036|H|irritating the esophagus or stomach.||
2626|037|H|   Take this medication 2 to 3 hours before or after taking any||
2626|038|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
2626|039|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
2626|040|H|sucralfate, vitamins/minerals, dairy products (such as milk,||
2626|041|H|yogurt), and juice with added calcium. These products bind with||
2626|042|H|minocycline, preventing your body from fully absorbing the drug.||
2626|043|H|   Tell your doctor if your condition does not get better or if||
2626|044|H|it gets worse.||
2626|045|B|||
2626|046|S|SIDE EFFECTS:  Stomach upset, lightheadedness, dizziness, or a||
2626|047|S|feeling of spinning may occur. If any of these effects last or||
2626|048|S|get worse, tell your doctor or pharmacist promptly.||
2626|049|S|   Remember that this medication has been prescribed because your||
2626|050|S|doctor has judged that the benefit to you is greater than the||
2626|051|S|risk of side effects. Many people using this medication do not||
2626|052|S|have serious side effects.||
2626|053|S|   Tell your doctor right away if you have any serious side||
2626|054|S|effects, including: painful/difficult swallowing, hearing changes||
2626|055|S|(such as ringing in the ears, decreased hearing), joint||
2626|056|S|stiffness/pain/swelling, signs of kidney problems (such as change||
2626|057|S|in the amount of urine, pink urine), signs of liver problems||
2626|058|S|(such as loss of appetite, stomach/abdominal pain, yellowing||
2626|059|S|eyes/skin, dark urine), yellow-gray-brown tooth discoloration,||
2626|060|S|blue-gray skin/tongue/lips/gums.||
2626|061|S|   Minocycline may rarely cause increased pressure around the||
2626|062|S|brain (intracranial hypertension-IH). The risk of this side||
2626|063|S|effect is greater for women of childbearing age who are||
2626|064|S|overweight or who have had IH in the past. If IH develops, it||
2626|065|S|usually goes away after minocycline is stopped; however, there is||
2626|066|S|a chance of permanent vision loss or blindness. Get medical help||
2626|067|S|right away if you have: severe/lasting headache, vision changes||
2626|068|S|(such as blurred/double vision, decreased vision, sudden||
2626|069|S|blindness), nausea/vomiting that doesn't stop.||
2626|070|S|   This medication may rarely cause a severe intestinal condition||
2626|071|S|due to a bacteria called C. difficile. This condition may occur||
2626|072|S|during treatment or weeks to months after treatment has stopped.||
2626|073|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2626|074|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2626|075|S|stool.||
2626|076|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2626|077|S|products because they may make symptoms worse.||
2626|078|S|   This medication may sometimes cause oral thrush or a new yeast||
2626|079|S|infection. Contact your doctor if you notice white patches in||
2626|080|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2626|081|S|   A very serious allergic reaction to this drug is rare.||
2626|082|S|However, get medical help right away if you notice any symptoms||
2626|083|S|of a serious allergic reaction, including: fever that doesn't go||
2626|084|S|away, swollen lymph nodes, rash, itching/swelling (especially of||
2626|085|S|the face/tongue/throat), severe dizziness, trouble breathing.||
2626|086|S|   This is not a complete list of possible side effects. If you||
2626|087|S|notice other effects not listed above, contact your doctor or||
2626|088|S|pharmacist.||
2626|089|S|   In the US -||
2626|090|S|   Call your doctor for medical advice about side effects. You||
2626|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2626|092|S|www.fda.gov/medwatch.||
2626|093|S|   In Canada - Call your doctor for medical advice about side||
2626|094|S|effects. You may report side effects to Health Canada at||
2626|095|S|1-866-234-2345.||
2626|096|B|||
2626|097|P|PRECAUTIONS:  See also Side Effects section.||
2626|098|P|   Before taking minocycline, tell your doctor or pharmacist if||
2626|099|P|you are allergic to it; or to other tetracyclines (such as||
2626|100|P|doxycycline); or if you have any other allergies. This product||
2626|101|P|may contain inactive ingredients, which can cause allergic||
2626|102|P|reactions or other problems. Talk to your pharmacist for more||
2626|103|P|details.||
2626|104|P|   Before using this medication, tell your doctor or pharmacist||
2626|105|P|your medical history, especially of: kidney problems, liver||
2626|106|P|problems, trouble swallowing, esophagus problems (such as hiatal||
2626|107|P|hernia or reflux/heartburn).||
2626|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2626|109|P|can make you more dizzy. Do not drive, use machinery, or do||
2626|110|P|anything that needs alertness until you can do it safely. Limit||
2626|111|P|alcoholic beverages. Talk to your doctor if you are using||
2626|112|P|marijuana (cannabis).||
2626|113|P|   This medication may make you more sensitive to the sun. Limit||
2626|114|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2626|115|P|sunscreen and wear protective clothing when outdoors. Tell your||
2626|116|P|doctor right away if you get sunburned or have skin||
2626|117|P|blisters/redness.||
2626|118|P|   Minocycline may cause live bacterial vaccines (such as typhoid||
2626|119|P|vaccine) to not work well. Tell your health care professional||
2626|120|P|that you are using minocycline before having any||
2626|121|P|immunizations/vaccinations.||
2626|122|P|   Before having surgery, tell your doctor or dentist about all||
2626|123|P|the products you use (including prescription drugs,||
2626|124|P|nonprescription drugs, and herbal products).||
2626|125|P|   Children younger than 8 years may be more sensitive to the||
2626|126|P|side effects of minocycline, especially tooth discoloration.||
2626|127|P|Tooth discoloration has also occurred in older children and in||
2626|128|P|young adults. Discuss the risks and benefits of this medication||
2626|129|P|with the doctor.||
2626|130|P|   Tell your doctor if you are pregnant or plan to become||
2626|131|P|pregnant. You should not become pregnant while using minocycline.||
2626|132|P|Minocycline may harm an unborn baby. If you become pregnant, talk||
2626|133|P|to your doctor right away about the risks and benefits of this||
2626|134|P|medication.||
2626|135|P|   This medication passes into breast milk. Consult your doctor||
2626|136|P|before breastfeeding.||
2626|137|B|||
2626|138|I|DRUG INTERACTIONS:  See also How to Use section.||
2626|139|I|   Drug interactions may change how your medications work or||
2626|140|I|increase your risk for serious side effects. This document does||
2626|141|I|not contain all possible drug interactions. Keep a list of all||
2626|142|I|the products you use (including prescription/nonprescription||
2626|143|I|drugs and herbal products) and share it with your doctor and||
2626|144|I|pharmacist. Do not start, stop, or change the dosage of any||
2626|145|I|medicines without your doctor's approval.||
2626|146|I|   Some products that may interact with this drug are: retinoid||
2626|147|I|medications taken by mouth (such as acitretin, isotretinoin),||
2626|148|I|strontium.||
2626|149|I|   This medication may interfere with certain lab tests (such as||
2626|150|I|urine catecholamine levels), possibly causing false test results.||
2626|151|I|Make sure lab personnel and all your doctors know you use this||
2626|152|I|drug.||
2626|153|B|||
2626|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2626|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2626|156|O|poison control center right away. US residents can call||
2626|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2626|158|B|||
2626|159|N|NOTES:  Do not share this medication with others.||
2626|160|N|   Lab and/or medical tests (such as complete blood count,||
2626|161|N|kidney/liver function) may be done while you are taking this||
2626|162|N|medication. Keep all medical and lab appointments.||
2626|163|B|||
2626|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2626|165|D|remember. If it is near the time of the next dose, skip the||
2626|166|D|missed dose. Take your next dose at the regular time. Do not||
2626|167|D|double the dose to catch up.||
2626|168|B|||
2626|169|R|STORAGE:  Store at room temperature away from light and moisture.||
2626|170|R|Do not store in the bathroom. Keep all medications away from||
2626|171|R|children and pets.||
2626|172|R|   Do not flush medications down the toilet or pour them into a||
2626|173|R|drain unless instructed to do so. Properly discard this product||
2626|174|R|when it is expired or no longer needed. Taking expired||
2626|175|R|minocycline can cause serious illness. Consult your pharmacist or||
2626|176|R|local waste disposal company.||
2626|177|B|||
2626|178|A|Information last revised September 2025.||
2626|179|A|Copyright(c) 2025 First Databank, Inc.||
2626|180|B|||
2627|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2627|002|Z|does NOT have all possible information about this product. This||
2627|003|Z|information does not assure that this product is safe, effective,||
2627|004|Z|or appropriate for you. This information is not individual||
2627|005|Z|medical advice and does not substitute for the advice of your||
2627|006|Z|health care professional. Always ask your health care||
2627|007|Z|professional for complete information about this product and your||
2627|008|Z|specific health needs.||
2627|009|B|||
2627|010|T|ARIPIPRAZOLE FILM - ORAL||
2627|011|F|(AR-i-PIP-ra-zole)||
2627|012|B|||
2627|013|C|COMMON BRAND NAME(S): Opipza||
2627|014|B|||
2627|015|W|WARNING:  If you are using aripiprazole in combination with other||
2627|016|W|medication to treat depression, also carefully read the drug||
2627|017|W|information for the other medication.||
2627|018|W|   There may be a slightly increased risk of serious, possibly||
2627|019|W|fatal side effects (such as stroke, heart failure, fast/irregular||
2627|020|W|heartbeat, pneumonia) when this medication is used by older||
2627|021|W|adults with dementia. This medication is not approved for the||
2627|022|W|treatment of dementia-related behavior problems. Discuss the||
2627|023|W|risks and benefits of this medication, as well as other effective||
2627|024|W|and possibly safer treatments for dementia-related behavior||
2627|025|W|problems, with the doctor.||
2627|026|B|||
2627|027|U|USES:  This medication is used to treat certain mental/mood||
2627|028|U|disorders (such as schizophrenia, Tourette's syndrome, and||
2627|029|U|irritability associated with autistic disorder). It may also be||
2627|030|U|used in combination with other medication to treat depression.||
2627|031|U|Aripiprazole belongs to a class of drugs known as atypical||
2627|032|U|antipsychotics. It works by helping to restore the balance of||
2627|033|U|certain natural substances in the brain.||
2627|034|B|||
2627|035|V|OTHER USES:  This section contains uses of this drug that are not||
2627|036|V|listed in the approved professional labeling for the drug but||
2627|037|V|that may be prescribed by your health care professional. Use this||
2627|038|V|drug for a condition that is listed in this section only if it||
2627|039|V|has been so prescribed by your health care professional.||
2627|040|V|   This medication may also be used for obsessive-compulsive||
2627|041|V|disorder.||
2627|042|B|||
2627|043|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2627|044|H|provided by your pharmacist before you start taking aripiprazole||
2627|045|H|and each time you get a refill. If you have any questions, ask||
2627|046|H|your doctor or pharmacist.||
2627|047|H|   Take this medication by mouth with or without food as directed||
2627|048|H|by your doctor, usually once daily. The dosage is based on your||
2627|049|H|medical condition, response to treatment, age, weight, and other||
2627|050|H|medications you may be taking. Be sure to tell your doctor and||
2627|051|H|pharmacist about all the products you use (including prescription||
2627|052|H|drugs, nonprescription drugs, and herbal products).||
2627|053|H|   Remove the film from the sealed pouch only when you are ready||
2627|054|H|to use it. With dry hands, place the medication on top of the||
2627|055|H|tongue and let it dissolve. Allow it to dissolve completely, then||
2627|056|H|swallow without any liquid. If your dose is for more than one||
2627|057|H|film, let the first film fully dissolve before using the second||
2627|058|H|film. Do not cut or split the film. Do not chew the film or||
2627|059|H|swallow it whole.||
2627|060|H|   To reduce your risk of side effects, your doctor may direct||
2627|061|H|you to start this medication at a low dose and gradually increase||
2627|062|H|your dose. Follow your doctor's instructions carefully.||
2627|063|H|   It may take several weeks before you get the full benefit of||
2627|064|H|this drug. Use this medication regularly to get the most benefit||
2627|065|H|from it. To help you remember, take it at the same time each day.||
2627|066|H|   Do not increase your dose or use this drug more often or for||
2627|067|H|longer than prescribed. Your condition will not improve any||
2627|068|H|faster, and your risk of side effects will increase.||
2627|069|H|   Keep taking this medication even if you feel well. Do not stop||
2627|070|H|taking this medication without consulting your doctor. Some||
2627|071|H|conditions may become worse when this drug is suddenly stopped.||
2627|072|H|Your dose may need to be gradually decreased.||
2627|073|H|   Tell your doctor if your condition does not get better or if||
2627|074|H|it gets worse.||
2627|075|B|||
2627|076|S|SIDE EFFECTS:  See also Warning section.||
2627|077|S|   Dizziness, lightheadedness, drowsiness, nausea, vomiting,||
2627|078|S|tiredness, excess saliva/drooling, blurred vision, weight gain,||
2627|079|S|constipation, headache, and trouble sleeping may occur. If any of||
2627|080|S|these effects last or get worse, tell your doctor or pharmacist||
2627|081|S|promptly.||
2627|082|S|   Dizziness and lightheadedness can increase the risk of||
2627|083|S|falling. Get up slowly when rising from a sitting or lying||
2627|084|S|position.||
2627|085|S|   Remember that this medication has been prescribed because your||
2627|086|S|doctor has judged that the benefit to you is greater than the||
2627|087|S|risk of side effects. Many people using this medication do not||
2627|088|S|have serious side effects.||
2627|089|S|   Tell your doctor right away if you have any serious side||
2627|090|S|effects, including: fainting, mental/mood changes (such as||
2627|091|S|increased anxiety, depression, suicidal thoughts), trouble||
2627|092|S|swallowing, restlessness (especially in the legs), shaking||
2627|093|S|(tremor), muscle spasm, mask-like expression of the face,||
2627|094|S|seizures, trouble controlling certain urges (such as gambling,||
2627|095|S|sex, eating or shopping), interrupted breathing during sleep.||
2627|096|S|   This medication may rarely make your blood sugar rise, which||
2627|097|S|can cause or worsen diabetes. Tell your doctor right away if you||
2627|098|S|have symptoms of high blood sugar such as increased||
2627|099|S|thirst/urination. If you already have diabetes, check your blood||
2627|100|S|sugar regularly as directed and share the results with your||
2627|101|S|doctor. Your doctor may need to adjust your diabetes medication,||
2627|102|S|exercise program, or diet.||
2627|103|S|   This medication may rarely cause a condition called tardive||
2627|104|S|dyskinesia. In some cases, this condition may be permanent. Tell||
2627|105|S|your doctor right away if you develop any unusual uncontrolled||
2627|106|S|movements (especially of the face, mouth, tongue, arms, or legs).||
2627|107|S|   This medication may rarely cause a very serious condition||
2627|108|S|called neuroleptic malignant syndrome (NMS). Get medical help||
2627|109|S|right away if you have any of the following symptoms: fever,||
2627|110|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
2627|111|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
2627|112|S|signs of kidney problems (such as change in the amount of urine).||
2627|113|S|   A very serious allergic reaction to this drug is rare.||
2627|114|S|However, get medical help right away if you notice any symptoms||
2627|115|S|of a serious allergic reaction, including: fever, swollen lymph||
2627|116|S|nodes, rash, itching/swelling (especially of the||
2627|117|S|face/tongue/throat), severe dizziness, trouble breathing.||
2627|118|S|   This is not a complete list of possible side effects. If you||
2627|119|S|notice other effects not listed above, contact your doctor or||
2627|120|S|pharmacist.||
2627|121|S|   In the US -||
2627|122|S|   Call your doctor for medical advice about side effects. You||
2627|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2627|124|S|www.fda.gov/medwatch.||
2627|125|S|   In Canada - Call your doctor for medical advice about side||
2627|126|S|effects. You may report side effects to Health Canada at||
2627|127|S|1-866-234-2345.||
2627|128|B|||
2627|129|P|PRECAUTIONS:  See also Warning section.||
2627|130|P|   Before taking aripiprazole, tell your doctor or pharmacist if||
2627|131|P|you are allergic to it; or if you have any other allergies. This||
2627|132|P|product may contain inactive ingredients, which can cause||
2627|133|P|allergic reactions or other problems. Talk to your pharmacist for||
2627|134|P|more details.||
2627|135|P|   Before using this medication, tell your doctor or pharmacist||
2627|136|P|your medical history, especially of: problems with blood flow in||
2627|137|P|the brain (such as cerebrovascular disease, stroke), diabetes||
2627|138|P|(including family history), heart problems (such as low blood||
2627|139|P|pressure, coronary artery disease, heart failure, irregular||
2627|140|P|heartbeat), nervous system problems (such as dementia, NMS,||
2627|141|P|seizures), obesity, low white blood cell count (including history||
2627|142|P|of low white blood cell count caused by medications), swallowing||
2627|143|P|problems, breathing trouble during sleep (sleep apnea).||
2627|144|P|   This drug may make you dizzy or drowsy or blur your vision.||
2627|145|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
2627|146|P|drowsy. Do not drive, use machinery, or do anything that needs||
2627|147|P|alertness or clear vision until you can do it safely. Avoid||
2627|148|P|alcoholic beverages. Talk to your doctor if you are using||
2627|149|P|marijuana (cannabis).||
2627|150|P|   This medication may make you sweat less, making you more||
2627|151|P|likely to get heat stroke. Avoid doing things that may cause you||
2627|152|P|to overheat, such as hard work or exercise in hot weather, or||
2627|153|P|using hot tubs. When the weather is hot, drink a lot of fluids||
2627|154|P|and dress lightly. If you overheat, quickly look for a place to||
2627|155|P|cool down and rest. Get medical help right away if you have a||
2627|156|P|fever that does not go away, mental/mood changes, headache, or||
2627|157|P|dizziness.||
2627|158|P|   Before having surgery, tell your doctor or dentist about all||
2627|159|P|the products you use (including prescription drugs,||
2627|160|P|nonprescription drugs, and herbal products).||
2627|161|P|   Older adults may be more sensitive to the side effects of this||
2627|162|P|drug, especially seizures, drowsiness, dizziness,||
2627|163|P|lightheadedness, confusion, tardive dyskinesia, swallowing||
2627|164|P|problems, and other serious (rarely fatal) side effects. (See||
2627|165|P|also Warning section.) Drowsiness, dizziness, lightheadedness,||
2627|166|P|and confusion can increase the risk of falling.||
2627|167|P|   During pregnancy, this medication should be used only when||
2627|168|P|clearly needed. Babies born to mothers who have used this drug||
2627|169|P|during the last 3 months of pregnancy may rarely develop symptoms||
2627|170|P|including muscle stiffness or shakiness, drowsiness,||
2627|171|P|feeding/breathing difficulties, or constant crying. If you notice||
2627|172|P|any of these symptoms in your newborn especially during their||
2627|173|P|first month, tell the doctor right away.||
2627|174|P|   Since untreated mental/mood problems (such as schizophrenia)||
2627|175|P|can be a serious condition, do not stop taking this medication||
2627|176|P|unless directed by your doctor. If you are planning pregnancy,||
2627|177|P|become pregnant, or think you may be pregnant, immediately||
2627|178|P|discuss with your doctor the benefits and risks of using this||
2627|179|P|medication during pregnancy.||
2627|180|P|   This medication passes into breast milk. Consult your doctor||
2627|181|P|before breastfeeding.||
2627|182|B|||
2627|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2627|184|I|medications work or increase your risk for serious side effects.||
2627|185|I|This document does not contain all possible drug interactions.||
2627|186|I|Keep a list of all the products you use (including||
2627|187|I|prescription/nonprescription drugs and herbal products) and share||
2627|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
2627|189|I|the dosage of any medicines without your doctor's approval.||
2627|190|I|   A product that may interact with this drug is: metoclopramide.||
2627|191|I|   Tell your doctor or pharmacist if you are taking other||
2627|192|I|products that cause drowsiness such as opioid pain or cough||
2627|193|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2627|194|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2627|195|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2627|196|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2627|197|I|diphenhydramine).||
2627|198|I|   Check the labels on all your medicines (such as allergy or||
2627|199|I|cough-and-cold products) because they may contain ingredients||
2627|200|I|that cause drowsiness. Ask your pharmacist about using those||
2627|201|I|products safely.||
2627|202|B|||
2627|203|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2627|204|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2627|205|O|poison control center right away. US residents can call||
2627|206|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2627|207|O|Symptoms of overdose may include: very fast heartbeat, loss of||
2627|208|O|consciousness.||
2627|209|B|||
2627|210|N|NOTES:  Do not share this medication with others.||
2627|211|N|   Lab and/or medical tests (such as blood sugar, weight,||
2627|212|N|cholesterol/triglyceride levels) may be done before you start||
2627|213|N|taking this medication and while you are taking it. Keep all||
2627|214|N|medical and lab appointments. Consult your doctor for more||
2627|215|N|details.||
2627|216|B|||
2627|217|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2627|218|D|remember. If it is near the time of the next dose, skip the||
2627|219|D|missed dose. Take your next dose at the regular time. Do not||
2627|220|D|double the dose to catch up.||
2627|221|B|||
2627|222|R|STORAGE:  Store in the original package at room temperature away||
2627|223|R|from light and moisture. Do not store in the bathroom. Keep all||
2627|224|R|medications away from children and pets.||
2627|225|R|   Do not flush medications down the toilet or pour them into a||
2627|226|R|drain unless instructed to do so. Properly discard this product||
2627|227|R|when it is expired or no longer needed. Consult your pharmacist||
2627|228|R|or local waste disposal company.||
2627|229|B|||
2627|230|A|Information last revised December 2024.||
2627|231|A|Copyright(c) 2025 First Databank, Inc.||
2627|232|B|||
2628|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2628|002|Z|does NOT have all possible information about this product. This||
2628|003|Z|information does not assure that this product is safe, effective,||
2628|004|Z|or appropriate for you. This information is not individual||
2628|005|Z|medical advice and does not substitute for the advice of your||
2628|006|Z|health care professional. Always ask your health care||
2628|007|Z|professional for complete information about this product and your||
2628|008|Z|specific health needs.||
2628|009|B|||
2628|010|T|PIVMECILLINAM - ORAL||
2628|011|B|||
2628|012|C|COMMON BRAND NAME(S): Pivya||
2628|013|B|||
2628|014|U|USES:  Pivmecillinam is used to treat bladder infections (urinary||
2628|015|U|tract infections) in women. This medication is a penicillin-type||
2628|016|U|antibiotic. It works by stopping the growth of bacteria.||
2628|017|U|   This antibiotic treats only bacterial infections. It will not||
2628|018|U|work for viral infections (such as common cold, flu). Using any||
2628|019|U|antibiotic when it is not needed can cause it to not work for||
2628|020|U|future infections.||
2628|021|B|||
2628|022|H|HOW TO USE:  Take this medication by mouth with or without food||
2628|023|H|as directed by your doctor, usually 3 times a day.||
2628|024|H|   For the best effect, take this antibiotic at evenly spaced||
2628|025|H|times. To help you remember, take this medication at the same||
2628|026|H|times every day.||
2628|027|H|   Continue to take this medication until the full prescribed||
2628|028|H|amount is finished, even if symptoms disappear after a few days.||
2628|029|H|Stopping the medication too early may result in a return of the||
2628|030|H|infection.||
2628|031|H|   Tell your doctor if your condition lasts or gets worse.||
2628|032|B|||
2628|033|S|SIDE EFFECTS:  Nausea, diarrhea, or headache may occur. If any of||
2628|034|S|these effects last or get worse, tell your doctor or pharmacist||
2628|035|S|promptly.||
2628|036|S|   Remember that this medication has been prescribed because your||
2628|037|S|doctor has judged that the benefit to you is greater than the||
2628|038|S|risk of side effects. Many people using this medication do not||
2628|039|S|have serious side effects.||
2628|040|S|   Tell your doctor right away if you have any serious side||
2628|041|S|effects, including: muscle pain/weakness, unusual tiredness,||
2628|042|S|signs of low blood sugar (such as sudden sweating, shaking, fast||
2628|043|S|heartbeat), mental/mood changes (such as anxiety, confusion).||
2628|044|S|   This medication may rarely cause a severe intestinal condition||
2628|045|S|due to a bacteria called C. difficile. This condition may occur||
2628|046|S|during treatment or weeks to months after treatment has stopped.||
2628|047|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2628|048|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2628|049|S|stool.||
2628|050|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2628|051|S|products because they may make symptoms worse.||
2628|052|S|   This medication may sometimes cause oral thrush or a new yeast||
2628|053|S|infection. Contact your doctor if you notice white patches in||
2628|054|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2628|055|S|   A very serious allergic reaction to this drug is rare.||
2628|056|S|However, get medical help right away if you notice any symptoms||
2628|057|S|of a serious allergic reaction, including: fever that doesn't go||
2628|058|S|away, new or worsening lymph node swelling, rash,||
2628|059|S|itching/swelling (especially of the face/tongue/throat), severe||
2628|060|S|dizziness, trouble breathing.||
2628|061|S|   This is not a complete list of possible side effects. If you||
2628|062|S|notice other effects not listed above, contact your doctor or||
2628|063|S|pharmacist.||
2628|064|S|   In the US -||
2628|065|S|   Call your doctor for medical advice about side effects. You||
2628|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2628|067|S|www.fda.gov/medwatch.||
2628|068|S|   In Canada - Call your doctor for medical advice about side||
2628|069|S|effects. You may report side effects to Health Canada at||
2628|070|S|1-866-234-2345.||
2628|071|B|||
2628|072|P|PRECAUTIONS:  Before taking pivmecillinam, tell your doctor or||
2628|073|P|pharmacist if you are allergic to it; or to related antibiotics||
2628|074|P|(such as penicillins, cephalosporins, carbapenems); or if you||
2628|075|P|have any other allergies. This product may contain inactive||
2628|076|P|ingredients, which can cause allergic reactions or other||
2628|077|P|problems. Talk to your pharmacist for more details.||
2628|078|P|   Before using this medication, tell your doctor or pharmacist||
2628|079|P|your medical history, especially of: a certain metabolic disorder||
2628|080|P|(carnitine deficiency), a certain blood disorder (porphyria),||
2628|081|P|kidney disease.||
2628|082|P|   Pivmecillinam may cause live bacterial vaccines (such as||
2628|083|P|typhoid vaccine) to not work well. Tell your health care||
2628|084|P|professional that you are using pivmecillinam before having any||
2628|085|P|immunizations/vaccinations.||
2628|086|P|   Before having surgery, tell your doctor or dentist about all||
2628|087|P|the products you use (including prescription drugs,||
2628|088|P|nonprescription drugs, and herbal products).||
2628|089|P|   During pregnancy, this medication should be used only when||
2628|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
2628|091|P|   It is unknown if this medication passes into breast milk.||
2628|092|P|Consult your doctor before breastfeeding.||
2628|093|B|||
2628|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2628|095|I|medications work or increase your risk for serious side effects.||
2628|096|I|This document does not contain all possible drug interactions.||
2628|097|I|Keep a list of all the products you use (including||
2628|098|I|prescription/nonprescription drugs and herbal products) and share||
2628|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2628|100|I|the dosage of any medicines without your doctor's approval.||
2628|101|I|   A product that may interact with this drug is: methotrexate.||
2628|102|I|   If this medication is used during pregnancy, it may interfere||
2628|103|I|with certain lab tests for the newborn (such as the newborn||
2628|104|I|screening test), possibly causing false test results. Make sure||
2628|105|I|lab personnel and all the doctors know you use this drug.||
2628|106|B|||
2628|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2628|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2628|109|O|poison control center right away. US residents can call||
2628|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2628|111|B|||
2628|112|N|NOTES:  Do not share this medication with others.||
2628|113|N|   This medication has been prescribed for your current condition||
2628|114|N|only. Do not use it later for another infection unless your||
2628|115|N|doctor tells you to.||
2628|116|B|||
2628|117|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2628|118|D|remember. If it is near the time of the next dose, skip the||
2628|119|D|missed dose. Take your next dose at the regular time. Do not||
2628|120|D|double the dose to catch up.||
2628|121|B|||
2628|122|R|STORAGE:  Store at room temperature away from light and moisture.||
2628|123|R|Keep the medication in the blister pack until ready to use. Do||
2628|124|R|not store in the bathroom. Keep all medications away from||
2628|125|R|children and pets.||
2628|126|R|   Do not flush medications down the toilet or pour them into a||
2628|127|R|drain unless instructed to do so. Properly discard this product||
2628|128|R|when it is expired or no longer needed. Consult your pharmacist||
2628|129|R|or local waste disposal company.||
2628|130|B|||
2628|131|A|Information last revised December 2024.||
2628|132|A|Copyright(c) 2025 First Databank, Inc.||
2628|133|B|||
2629|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2629|002|Z|does NOT have all possible information about this product. This||
2629|003|Z|information does not assure that this product is safe, effective,||
2629|004|Z|or appropriate for you. This information is not individual||
2629|005|Z|medical advice and does not substitute for the advice of your||
2629|006|Z|health care professional. Always ask your health care||
2629|007|Z|professional for complete information about this product and your||
2629|008|Z|specific health needs.||
2629|009|B|||
2629|010|T|REVUMENIB - ORAL||
2629|011|B|||
2629|012|C|COMMON BRAND NAME(S): Revuforj||
2629|013|B|||
2629|014|W|WARNING:  Revumenib may cause a serious (possibly fatal)||
2629|015|W|condition called differentiation syndrome. Get medical help right||
2629|016|W|away if you develop any signs of differentiation syndrome, such||
2629|017|W|as fever, cough, shortness of breath, decreased urination, rapid||
2629|018|W|weight gain, swelling of the arms/legs, or||
2629|019|W|dizziness/lightheadedness.||
2629|020|W|   Revumenib may cause a condition that affects the heart rhythm||
2629|021|W|(QT prolongation), which can lead to a serious (rarely fatal)||
2629|022|W|fast/irregular heartbeat. Your doctor will monitor you closely||
2629|023|W|before and during treatment with this medication. Keep all||
2629|024|W|medical and lab appointments. See also Precautions section.||
2629|025|B|||
2629|026|U|USES:  This medication is used to treat a certain type of cancer||
2629|027|U|(acute leukemia). Revumenib works by stopping or slowing the||
2629|028|U|growth of cancer cells.||
2629|029|B|||
2629|030|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2629|031|H|provided by your pharmacist before you start taking revumenib and||
2629|032|H|each time you get a refill. If you have any questions, ask your||
2629|033|H|doctor or pharmacist.||
2629|034|H|   Take this medication by mouth on an empty stomach or with a||
2629|035|H|low-fat meal as directed by your doctor, usually twice daily||
2629|036|H|(about 12 hours apart). Swallow the tablets whole with a cup (8||
2629|037|H|ounces/240 milliliters) of water. Do not cut or chew the tablets.||
2629|038|H|   If you have trouble swallowing the tablets whole, you may||
2629|039|H|crush the tablets into a powder. Add the crushed tablet(s) to a||
2629|040|H|cup with 2 teaspoons (10 milliliters) of water. For 5 minutes,||
2629|041|H|swirl the cup once every 30 seconds to 1 minute. Then draw up the||
2629|042|H|mixture into an oral syringe right away. The mixture will look||
2629|043|H|cloudy. Before giving it, turn the oral syringe upside down and||
2629|044|H|back several times. Swallow the mixture while sitting up straight||
2629|045|H|or standing, and stay in this position for 2 to 3 minutes||
2629|046|H|afterward. Rinse the cup with another 2 teaspoons (10||
2629|047|H|milliliters) of water, then swirl and drink the remaining mixture||
2629|048|H|to make sure you get the full dose. The medication must be taken||
2629|049|H|within 2 hours of mixing.||
2629|050|H|   The dosage is based on your medical condition, weight, body||
2629|051|H|size, response to treatment, and other medications you may be||
2629|052|H|taking. Be sure to tell your doctor and pharmacist about all the||
2629|053|H|products you use (including prescription drugs, nonprescription||
2629|054|H|drugs, and herbal products).||
2629|055|H|   Use this medication regularly to get the most benefit from it.||
2629|056|H|To help you remember, take it at the same times each day.||
2629|057|H|   Do not increase your dose or use this drug more often or for||
2629|058|H|longer than prescribed. Your condition will not improve any||
2629|059|H|faster, and your risk of side effects will increase.||
2629|060|H|   If you vomit after taking a dose, do not take another dose.||
2629|061|H|Take your next dose at the regular time. Do not double the dose||
2629|062|H|to catch up.||
2629|063|H|   Since this drug can be absorbed through the skin and lungs and||
2629|064|H|may harm an unborn baby, women who are pregnant or who may become||
2629|065|H|pregnant should not handle this medication or breathe the dust||
2629|066|H|from the tablets.||
2629|067|B|||
2629|068|S|SIDE EFFECTS:  See also Warning section.||
2629|069|S|   Nausea, vomiting, muscle/joint pain, diarrhea, constipation,||
2629|070|S|tiredness, or decreased appetite may occur. If any of these||
2629|071|S|effects last or get worse, tell your doctor or pharmacist||
2629|072|S|promptly.||
2629|073|S|   Remember that this medication has been prescribed because your||
2629|074|S|doctor has judged that the benefit to you is greater than the||
2629|075|S|risk of side effects. Many people using this medication do not||
2629|076|S|have serious side effects.||
2629|077|S|   Tell your doctor right away if you have any serious side||
2629|078|S|effects, including: unusual bleeding/bruising.||
2629|079|S|   Get medical help right away if you have any very serious side||
2629|080|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2629|081|S|fainting.||
2629|082|S|   A very serious allergic reaction to this drug is rare.||
2629|083|S|However, get medical help right away if you notice any symptoms||
2629|084|S|of a serious allergic reaction, including: rash, itching/swelling||
2629|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2629|086|S|breathing.||
2629|087|S|   This is not a complete list of possible side effects. If you||
2629|088|S|notice other effects not listed above, contact your doctor or||
2629|089|S|pharmacist.||
2629|090|S|   In the US -||
2629|091|S|   Call your doctor for medical advice about side effects. You||
2629|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2629|093|S|www.fda.gov/medwatch.||
2629|094|S|   In Canada - Call your doctor for medical advice about side||
2629|095|S|effects. You may report side effects to Health Canada at||
2629|096|S|1-866-234-2345.||
2629|097|B|||
2629|098|P|PRECAUTIONS:  Before taking revumenib, tell your doctor or||
2629|099|P|pharmacist if you are allergic to it; or if you have any other||
2629|100|P|allergies. This product may contain inactive ingredients, which||
2629|101|P|can cause allergic reactions or other problems. Talk to your||
2629|102|P|pharmacist for more details.||
2629|103|P|   Before using this medication, tell your doctor or pharmacist||
2629|104|P|your medical history.||
2629|105|P|   Revumenib may cause a condition that affects the heart rhythm||
2629|106|P|(QT prolongation). QT prolongation can rarely cause serious||
2629|107|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2629|108|P|as severe dizziness, fainting) that need medical attention right||
2629|109|P|away.||
2629|110|P|   The risk of QT prolongation may be increased if you have||
2629|111|P|certain medical conditions or are taking other drugs that may||
2629|112|P|cause QT prolongation. Before using revumenib, tell your doctor||
2629|113|P|or pharmacist of all the drugs you take and if you have any of||
2629|114|P|the following conditions: certain heart problems (heart failure,||
2629|115|P|slow heartbeat, QT prolongation in the EKG), family history of||
2629|116|P|certain heart problems (QT prolongation in the EKG, sudden||
2629|117|P|cardiac death).||
2629|118|P|   Low levels of potassium or magnesium in the blood may also||
2629|119|P|increase your risk of QT prolongation. This risk may increase if||
2629|120|P|you use certain drugs (such as diuretics/"water pills") or if you||
2629|121|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2629|122|P|Talk to your doctor about using revumenib safely.||
2629|123|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2629|124|P|can make you more dizzy. Do not drive, use machinery, or do||
2629|125|P|anything that needs alertness until you can do it safely. Limit||
2629|126|P|alcoholic beverages. Talk to your doctor if you are using||
2629|127|P|marijuana (cannabis).||
2629|128|P|   Before having surgery, tell your doctor or dentist about all||
2629|129|P|the products you use (including prescription drugs,||
2629|130|P|nonprescription drugs, and herbal products).||
2629|131|P|   Older adults may be more sensitive to the side effects of this||
2629|132|P|drug, especially QT prolongation (see above) and swelling of the||
2629|133|P|arms/legs.||
2629|134|P|   Since this drug can be absorbed through the skin and lungs and||
2629|135|P|may harm an unborn baby, women who are pregnant or who may become||
2629|136|P|pregnant should not handle this medication or breathe the dust||
2629|137|P|from the tablets.||
2629|138|P|   Tell your doctor if you are pregnant or plan to become||
2629|139|P|pregnant. You should not become pregnant while using revumenib.||
2629|140|P|Revumenib may harm an unborn baby. Your doctor should order a||
2629|141|P|pregnancy test before you start this medication. Men and women||
2629|142|P|using this medication should ask about reliable forms of birth||
2629|143|P|control during treatment and for 4 months after the last dose. If||
2629|144|P|you or your partner becomes pregnant, talk to your doctor right||
2629|145|P|away about the risks and benefits of this medication.||
2629|146|P|   It is unknown if this medication passes into breast milk.||
2629|147|P|Because of the possible risk to the infant, breastfeeding is not||
2629|148|P|recommended while using this medication and for 1 week after the||
2629|149|P|last dose. Consult your doctor before breastfeeding.||
2629|150|B|||
2629|151|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2629|152|I|medications work or increase your risk for serious side effects.||
2629|153|I|This document does not contain all possible drug interactions.||
2629|154|I|Keep a list of all the products you use (including||
2629|155|I|prescription/nonprescription drugs and herbal products) and share||
2629|156|I|it with your doctor and pharmacist. Do not start, stop, or change||
2629|157|I|the dosage of any medicines without your doctor's approval.||
2629|158|I|   Other medications can affect the removal of revumenib from||
2629|159|I|your body, which may affect how revumenib works. Examples include||
2629|160|I|apalutamide, dabrafenib, elagolix, modafinil, nafcillin,||
2629|161|I|posaconazole, rifamycins (such as rifampin), certain drugs used||
2629|162|I|to treat seizures (such as carbamazepine, phenobarbital,||
2629|163|I|phenytoin), sotorasib, St. John's wort, among others.||
2629|164|B|||
2629|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2629|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2629|167|O|poison control center right away. US residents can call||
2629|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2629|169|B|||
2629|170|N|NOTES:  Do not share this medication with others.||
2629|171|N|   Lab and/or medical tests (such as complete blood count, blood||
2629|172|N|mineral levels, liver function, EKG) should be done before you||
2629|173|N|start taking this medication and while you are taking it. Keep||
2629|174|N|all medical and lab appointments. Consult your doctor for more||
2629|175|N|details.||
2629|176|B|||
2629|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
2629|178|D|on the same day. If it is less than 12 hours before the next||
2629|179|D|dose, skip the missed dose. Take your next dose at the regular||
2629|180|D|time. Do not double the dose to catch up.||
2629|181|B|||
2629|182|R|STORAGE:  Store in the original bottle at room temperature away||
2629|183|R|from light and moisture. Do not store in the bathroom. Keep all||
2629|184|R|medications away from children and pets.||
2629|185|R|   Do not flush medications down the toilet or pour them into a||
2629|186|R|drain unless instructed to do so. Properly discard this product||
2629|187|R|when it is expired or no longer needed. Consult your pharmacist||
2629|188|R|or local waste disposal company.||
2629|189|B|||
2629|190|A|Information last revised October 2025.||
2629|191|A|Copyright(c) 2025 First Databank, Inc.||
2629|192|B|||
2630|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2630|002|Z|does NOT have all possible information about this product. This||
2630|003|Z|information does not assure that this product is safe, effective,||
2630|004|Z|or appropriate for you. This information is not individual||
2630|005|Z|medical advice and does not substitute for the advice of your||
2630|006|Z|health care professional. Always ask your health care||
2630|007|Z|professional for complete information about this product and your||
2630|008|Z|specific health needs.||
2630|009|B|||
2630|010|T|ZANIDATAMAB - INJECTION||
2630|011|B|||
2630|012|C|COMMON BRAND NAME(S): Ziihera||
2630|013|B|||
2630|014|W|WARNING:  Zanidatamab can cause serious (possibly fatal) harm to||
2630|015|W|an unborn baby if used during pregnancy. Discuss reliable forms||
2630|016|W|of birth control with your doctor.||
2630|017|B|||
2630|018|U|USES:  This medication is used to treat biliary tract cancer.||
2630|019|U|Zanidatamab belongs to a class of drugs known as monoclonal||
2630|020|U|antibodies. Zanidatamab works by slowing or stopping the growth||
2630|021|U|of cancer cells.||
2630|022|B|||
2630|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2630|024|H|from your pharmacist before you start using zanidatamab and each||
2630|025|H|time you get a treatment. If you have any questions, ask your||
2630|026|H|doctor or pharmacist.||
2630|027|H|   This medication is given by a health care professional. It is||
2630|028|H|injected slowly into a vein over 60 to 150 minutes. It is given||
2630|029|H|as directed by your doctor, usually once every 2 weeks. The||
2630|030|H|dosage is based on your medical condition, weight, and response||
2630|031|H|to treatment.||
2630|032|H|   Infusion reactions may happen during the infusion of this||
2630|033|H|drug. Your doctor may prescribe other medications (such as||
2630|034|H|acetaminophen, antihistamines, corticosteroids) before each||
2630|035|H|treatment to help prevent these side effects. Tell your doctor||
2630|036|H|right away if you have any symptoms of infusion reactions such as||
2630|037|H|fever, chills, flushing, shortness of breath, nausea, vomiting,||
2630|038|H|chest pain, or dizziness. Your doctor may give you other||
2630|039|H|medications to help with these side effects or may slow down or||
2630|040|H|stop your treatment for some time.||
2630|041|H|   Use this medication regularly to get the most benefit from it.||
2630|042|H|To help you remember, mark your calendar with a reminder.||
2630|043|B|||
2630|044|S|SIDE EFFECTS:  See also How to Use section.||
2630|045|S|   Tiredness, abdominal pain, or diarrhea may occur. Diarrhea can||
2630|046|S|be severe. In some cases, your doctor may prescribe medication to||
2630|047|S|treat diarrhea. If any of these effects last or get worse, tell||
2630|048|S|your doctor or pharmacist promptly.||
2630|049|S|   Remember that this medication has been prescribed because your||
2630|050|S|doctor has judged that the benefit to you is greater than the||
2630|051|S|risk of side effects. Many people using this medication do not||
2630|052|S|have serious side effects.||
2630|053|S|   Tell your doctor right away if you have any serious side||
2630|054|S|effects, including: signs of heart problems (such as shortness of||
2630|055|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
2630|056|S|weight gain).||
2630|057|S|   A very serious allergic reaction to this drug is rare.||
2630|058|S|However, get medical help right away if you notice any symptoms||
2630|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2630|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2630|061|S|breathing.||
2630|062|S|   This is not a complete list of possible side effects. If you||
2630|063|S|notice other effects not listed above, contact your doctor or||
2630|064|S|pharmacist.||
2630|065|S|   In the US -||
2630|066|S|   Call your doctor for medical advice about side effects. You||
2630|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2630|068|S|www.fda.gov/medwatch.||
2630|069|S|   In Canada - Call your doctor for medical advice about side||
2630|070|S|effects. You may report side effects to Health Canada at||
2630|071|S|1-866-234-2345.||
2630|072|B|||
2630|073|P|PRECAUTIONS:  Before using zanidatamab, tell your doctor or||
2630|074|P|pharmacist if you are allergic to it; or if you have any other||
2630|075|P|allergies. This product may contain inactive ingredients, which||
2630|076|P|can cause allergic reactions or other problems. Talk to your||
2630|077|P|pharmacist for more details.||
2630|078|P|   Before using this medication, tell your doctor or pharmacist||
2630|079|P|your medical history, especially of: heart disease (such as heart||
2630|080|P|failure).||
2630|081|P|   Before having surgery, tell your doctor or dentist about all||
2630|082|P|the products you use (including prescription drugs,||
2630|083|P|nonprescription drugs, and herbal products).||
2630|084|P|   Tell your doctor if you are pregnant or plan to become||
2630|085|P|pregnant. You should not become pregnant while using zanidatamab.||
2630|086|P|Zanidatamab may harm an unborn baby. Your doctor should order a||
2630|087|P|pregnancy test before you start this medication. Ask about||
2630|088|P|reliable forms of birth control while using this medication and||
2630|089|P|for 4 months after the last dose. If you become pregnant, talk to||
2630|090|P|your doctor right away about the risks and benefits of this||
2630|091|P|medication. See also Warning section.||
2630|092|P|   It is unknown if this medication passes into breast milk.||
2630|093|P|Consult your doctor before breastfeeding.||
2630|094|B|||
2630|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2630|096|I|medications work or increase your risk for serious side effects.||
2630|097|I|This document does not contain all possible drug interactions.||
2630|098|I|Keep a list of all the products you use (including||
2630|099|I|prescription/nonprescription drugs and herbal products) and share||
2630|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
2630|101|I|the dosage of any medicines without your doctor's approval.||
2630|102|B|||
2630|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2630|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2630|105|O|poison control center right away. US residents can call||
2630|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2630|107|B|||
2630|108|N|NOTES:  Lab and/or medical tests (such as heart function) should||
2630|109|N|be done before you start using this medication and while you are||
2630|110|N|using it. Keep all medical and lab appointments. Consult your||
2630|111|N|doctor for more details.||
2630|112|B|||
2630|113|D|MISSED DOSE:  It is important to get each dose of this medication||
2630|114|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2630|115|D|right away for a new dosing schedule.||
2630|116|B|||
2630|117|R|STORAGE:  Not applicable. This medication is given in a hospital||
2630|118|R|or clinic and will not be stored at home.||
2630|119|B|||
2630|120|A|Information last revised December 2024.||
2630|121|A|Copyright(c) 2025 First Databank, Inc.||
2630|122|B|||
2631|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2631|002|Z|does NOT have all possible information about this product. This||
2631|003|Z|information does not assure that this product is safe, effective,||
2631|004|Z|or appropriate for you. This information is not individual||
2631|005|Z|medical advice and does not substitute for the advice of your||
2631|006|Z|health care professional. Always ask your health care||
2631|007|Z|professional for complete information about this product and your||
2631|008|Z|specific health needs.||
2631|009|B|||
2631|010|T|ACORAMIDIS - ORAL||
2631|011|B|||
2631|012|C|COMMON BRAND NAME(S): Attruby||
2631|013|B|||
2631|014|U|USES:  This medication is used to treat a certain type of heart||
2631|015|U|failure (transthyretin-mediated amyloidosis). It is used to help||
2631|016|U|prevent the heart failure from getting worse and needing||
2631|017|U|treatment in a hospital. Acoramidis works by slowing the buildup||
2631|018|U|of a certain protein (amyloid fibrils) that causes heart||
2631|019|U|problems.||
2631|020|B|||
2631|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2631|022|H|from your pharmacist before you start taking acoramidis and each||
2631|023|H|time you get a refill. If you have any questions, ask your doctor||
2631|024|H|or pharmacist.||
2631|025|H|   Take this medication by mouth with or without food as directed||
2631|026|H|by your doctor, usually twice daily. Swallow the tablets whole.||
2631|027|H|Do not cut, crush, or chew the tablets.||
2631|028|H|   Use this medication regularly to get the most benefit from it.||
2631|029|H|To help you remember, take it at the same times each day.||
2631|030|H|   Do not increase your dose or use this drug more often or for||
2631|031|H|longer than prescribed. Your condition will not improve any||
2631|032|H|faster, and your risk of side effects will increase.||
2631|033|H|   Tell your doctor if you do not get better or if you get worse.||
2631|034|B|||
2631|035|S|SIDE EFFECTS:  Diarrhea or stomach/abdominal pain may occur. If||
2631|036|S|either of these effects lasts or gets worse, tell your doctor or||
2631|037|S|pharmacist promptly.||
2631|038|S|   Remember that this medication has been prescribed because your||
2631|039|S|doctor has judged that the benefit to you is greater than the||
2631|040|S|risk of side effects. Many people using this medication do not||
2631|041|S|have serious side effects.||
2631|042|S|   A very serious allergic reaction to this drug is rare.||
2631|043|S|However, get medical help right away if you notice any symptoms||
2631|044|S|of a serious allergic reaction, including: rash, itching/swelling||
2631|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2631|046|S|breathing.||
2631|047|S|   This is not a complete list of possible side effects. If you||
2631|048|S|notice other effects not listed above, contact your doctor or||
2631|049|S|pharmacist.||
2631|050|S|   In the US -||
2631|051|S|   Call your doctor for medical advice about side effects. You||
2631|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2631|053|S|www.fda.gov/medwatch.||
2631|054|S|   In Canada - Call your doctor for medical advice about side||
2631|055|S|effects. You may report side effects to Health Canada at||
2631|056|S|1-866-234-2345.||
2631|057|B|||
2631|058|P|PRECAUTIONS:  Before taking acoramidis, tell your doctor or||
2631|059|P|pharmacist if you are allergic to it; or if you have any other||
2631|060|P|allergies. This product may contain inactive ingredients, which||
2631|061|P|can cause allergic reactions or other problems. Talk to your||
2631|062|P|pharmacist for more details.||
2631|063|P|   Before using this medication, tell your doctor or pharmacist||
2631|064|P|your medical history.||
2631|065|P|   Before having surgery, tell your doctor or dentist about all||
2631|066|P|the products you use (including prescription drugs,||
2631|067|P|nonprescription drugs, and herbal products).||
2631|068|P|   During pregnancy, this medication should be used only when||
2631|069|P|clearly needed. Discuss the risks and benefits with your doctor.||
2631|070|P|   It is unknown if this medication passes into breast milk.||
2631|071|P|Consult your doctor before breastfeeding.||
2631|072|B|||
2631|073|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2631|074|I|medications work or increase your risk for serious side effects.||
2631|075|I|This document does not contain all possible drug interactions.||
2631|076|I|Keep a list of all the products you use (including||
2631|077|I|prescription/nonprescription drugs and herbal products) and share||
2631|078|I|it with your doctor and pharmacist. Do not start, stop, or change||
2631|079|I|the dosage of any medicines without your doctor's approval.||
2631|080|I|   This medication may interfere with certain lab tests (such as||
2631|081|I|thyroid tests), possibly causing false test results. Make sure||
2631|082|I|lab personnel and all your doctors know you use this drug.||
2631|083|B|||
2631|084|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2631|085|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2631|086|O|poison control center right away. US residents can call||
2631|087|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2631|088|B|||
2631|089|N|NOTES:  Do not share this medication with others.||
2631|090|B|||
2631|091|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2631|092|D|remember. If it is near the time of the next dose, skip the||
2631|093|D|missed dose. Take your next dose at the regular time. Do not||
2631|094|D|double the dose to catch up.||
2631|095|B|||
2631|096|R|STORAGE:  Store at room temperature away from light and moisture.||
2631|097|R|Keep the medication in the original packaging until ready to use.||
2631|098|R|Do not store in the bathroom. Keep all medications away from||
2631|099|R|children and pets.||
2631|100|R|   Do not flush medications down the toilet or pour them into a||
2631|101|R|drain unless instructed to do so. Properly discard this product||
2631|102|R|when it is expired or no longer needed. Consult your pharmacist||
2631|103|R|or local waste disposal company.||
2631|104|B|||
2631|105|A|Information last revised December 2024.||
2631|106|A|Copyright(c) 2025 First Databank, Inc.||
2631|107|B|||
2632|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2632|002|Z|does NOT have all possible information about this product. This||
2632|003|Z|information does not assure that this product is safe, effective,||
2632|004|Z|or appropriate for you. This information is not individual||
2632|005|Z|medical advice and does not substitute for the advice of your||
2632|006|Z|health care professional. Always ask your health care||
2632|007|Z|professional for complete information about this product and your||
2632|008|Z|specific health needs.||
2632|009|B|||
2632|010|T|CLINDAMYCIN FOAM - TOPICAL||
2632|011|F|(KLIN-da-MYE-sin)||
2632|012|B|||
2632|013|C|COMMON BRAND NAME(S): Clindacin||
2632|014|B|||
2632|015|U|USES:  This medication is used to treat acne. It helps to||
2632|016|U|decrease the number of acne lesions. Clindamycin is an antibiotic||
2632|017|U|which works by stopping the growth of bacteria.||
2632|018|B|||
2632|019|H|HOW TO USE:  Read the Patient Information Leaflet and||
2632|020|H|Instructions for Use if available from your pharmacist before you||
2632|021|H|start using this medication and each time you get a refill. If||
2632|022|H|you have any questions, ask your doctor or pharmacist.||
2632|023|H|   Clean and dry the affected skin first. Apply this medication||
2632|024|H|to the affected area as directed by your doctor, usually once||
2632|025|H|daily.||
2632|026|H|   When using this product, do not spray the foam directly onto||
2632|027|H|your hands or face because the foam will begin to melt when it||
2632|028|H|touches the warm skin. Instead spray the amount needed directly||
2632|029|H|into the cap or onto a cool surface such as a countertop. Use||
2632|030|H|your fingertips to pick up the foam in small amounts and gently||
2632|031|H|rub the foam into the affected area. Use enough foam to cover the||
2632|032|H|entire affected area. Wash your hands after each use.||
2632|033|H|   This medication is for use on the skin only. Avoid getting||
2632|034|H|this medication into your eyes, nose, mouth, or on any areas of||
2632|035|H|broken skin. If this medication gets in those areas, rinse well||
2632|036|H|with plenty of cool water.||
2632|037|H|   This medication is flammable until dry. Avoid smoking or being||
2632|038|H|near open flames while using the medication and until the||
2632|039|H|medication has dried.||
2632|040|H|   Use this medication regularly to get the most benefit from it.||
2632|041|H|To help you remember, use it at the same time each day.||
2632|042|H|   Do not increase your dose or use this drug more often or for||
2632|043|H|longer than prescribed. Your condition will not improve any||
2632|044|H|faster, and your risk of side effects will increase.||
2632|045|H|   It may take 6 to 8 weeks for your condition to get better, and||
2632|046|H|up to 12 weeks before you get the full benefit of this drug.||
2632|047|H|   Tell your doctor if your condition does not get better or if||
2632|048|H|it gets worse.||
2632|049|B|||
2632|050|S|SIDE EFFECTS:  Burning, itching, or dryness at the application||
2632|051|S|site may occur. If any of these effects last or get worse, tell||
2632|052|S|your doctor or pharmacist promptly.||
2632|053|S|   Remember that this medication has been prescribed because your||
2632|054|S|doctor has judged that the benefit to you is greater than the||
2632|055|S|risk of side effects. Many people using this medication do not||
2632|056|S|have serious side effects.||
2632|057|S|   This medication may be absorbed into your bloodstream and very||
2632|058|S|rarely cause a severe intestinal condition due to a bacteria||
2632|059|S|called C. difficile. This condition may occur during treatment or||
2632|060|S|weeks to months after treatment has stopped. Tell your doctor||
2632|061|S|right away if you develop: diarrhea that doesn't stop, abdominal||
2632|062|S|or stomach pain/cramping, blood/mucus in your stool.||
2632|063|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2632|064|S|products because they may make symptoms worse.||
2632|065|S|   A very serious allergic reaction to this drug is rare.||
2632|066|S|However, get medical help right away if you notice any symptoms||
2632|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2632|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2632|069|S|breathing.||
2632|070|S|   This is not a complete list of possible side effects. If you||
2632|071|S|notice other effects not listed above, contact your doctor or||
2632|072|S|pharmacist.||
2632|073|S|   In the US -||
2632|074|S|   Call your doctor for medical advice about side effects. You||
2632|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2632|076|S|www.fda.gov/medwatch.||
2632|077|S|   In Canada - Call your doctor for medical advice about side||
2632|078|S|effects. You may report side effects to Health Canada at||
2632|079|S|1-866-234-2345.||
2632|080|B|||
2632|081|P|PRECAUTIONS:  Before using clindamycin, tell your doctor or||
2632|082|P|pharmacist if you are allergic to it; or to lincomycin; or if you||
2632|083|P|have any other allergies. This product may contain inactive||
2632|084|P|ingredients, which can cause allergic reactions or other||
2632|085|P|problems. Talk to your pharmacist for more details.||
2632|086|P|   Before using this medication, tell your doctor or pharmacist||
2632|087|P|your medical history, especially of: allergic conditions (such as||
2632|088|P|asthma, hay fever, eczema), intestinal diseases (such as||
2632|089|P|ulcerative colitis, enteritis, C. difficile-associated diarrhea).||
2632|090|P|   Before having surgery, tell your doctor or dentist about all||
2632|091|P|the products you use (including prescription drugs,||
2632|092|P|nonprescription drugs, and herbal products).||
2632|093|P|   Tell your doctor if you are pregnant before using this||
2632|094|P|medication.||
2632|095|P|   It is unknown if this medication passes into breast milk.||
2632|096|P|Consult your doctor before breastfeeding.||
2632|097|B|||
2632|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2632|099|I|medications work or increase your risk for serious side effects.||
2632|100|I|This document does not contain all possible drug interactions.||
2632|101|I|Keep a list of all the products you use (including||
2632|102|I|prescription/nonprescription drugs and herbal products) and share||
2632|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
2632|104|I|the dosage of any medicines without your doctor's approval.||
2632|105|B|||
2632|106|O|OVERDOSE:  This medication may be harmful if swallowed. If||
2632|107|O|someone has overdosed and has serious symptoms such as passing||
2632|108|O|out or trouble breathing, call 911. Otherwise, call a poison||
2632|109|O|control center right away. US residents can call 1-800-222-1222.||
2632|110|O|Canada residents can call 1-844-764-7669.||
2632|111|B|||
2632|112|N|NOTES:  Do not share this medication with others.||
2632|113|B|||
2632|114|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2632|115|D|If it is near the time of the next dose, skip the missed dose.||
2632|116|D|Use your next dose at the regular time. Do not double the dose to||
2632|117|D|catch up.||
2632|118|B|||
2632|119|R|STORAGE:  Store at room temperature away from heat and open||
2632|120|R|flame. Do not puncture or burn the container. Keep all||
2632|121|R|medications away from children and pets.||
2632|122|R|   Do not flush medications down the toilet or pour them into a||
2632|123|R|drain unless instructed to do so. Properly discard this product||
2632|124|R|when it is expired or no longer needed. Consult your pharmacist||
2632|125|R|or local waste disposal company.||
2632|126|B|||
2632|127|A|Information last revised August 2025.||
2632|128|A|Copyright(c) 2025 First Databank, Inc.||
2632|129|B|||
2633|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2633|002|Z|does NOT have all possible information about this product. This||
2633|003|Z|information does not assure that this product is safe, effective,||
2633|004|Z|or appropriate for you. This information is not individual||
2633|005|Z|medical advice and does not substitute for the advice of your||
2633|006|Z|health care professional. Always ask your health care||
2633|007|Z|professional for complete information about this product and your||
2633|008|Z|specific health needs.||
2633|009|B|||
2633|010|T|VANZACAFTOR/TEZACAFTOR/DEUTIVACAFTOR - ORAL||
2633|011|F|(VAN-zah-KAF-tor/TEZ-a-KAF-tor/due-TIV-a-KAF-tor)||
2633|012|B|||
2633|013|C|COMMON BRAND NAME(S): Alyftrek||
2633|014|B|||
2633|015|W|WARNING:  This medication may rarely cause serious (possibly||
2633|016|W|fatal) liver problems. Before and during treatment with this||
2633|017|W|medication, you will have certain blood tests (liver function) to||
2633|018|W|monitor for liver problems. Keep all medical and lab||
2633|019|W|appointments. Get medical help right away if you have any||
2633|020|W|symptoms of liver damage, such as: nausea/vomiting that doesn't||
2633|021|W|stop, stomach/abdominal pain, dark urine, loss of appetite,||
2633|022|W|yellowing eyes/skin.||
2633|023|B|||
2633|024|U|USES:  This medication is a combination of 3 medications:||
2633|025|U|vanzacaftor, tezacaftor, and deutivacaftor. This medication is||
2633|026|U|used to treat cystic fibrosis in certain people (those with an||
2633|027|U|abnormal "CFTR" gene). It may help to improve breathing, reduce||
2633|028|U|the risk of lung infections, and improve weight gain.||
2633|029|B|||
2633|030|H|HOW TO USE:  Read the Medication Guide provided by your||
2633|031|H|pharmacist before you start taking this medication and each time||
2633|032|H|you get a refill. If you have any questions, ask your doctor or||
2633|033|H|pharmacist.||
2633|034|H|   Take this medication by mouth as directed by your doctor,||
2633|035|H|usually once daily. Take the tablet with food that contains fat.||
2633|036|H|Some examples are eggs, meat, nuts, butter, peanut butter,||
2633|037|H|whole-milk dairy products (such as whole milk, cheese, yogurt).||
2633|038|H|   The manufacturer directs to swallow this medication whole.||
2633|039|H|However, many similar drugs (immediate-release tablets) can be||
2633|040|H|split/crushed. Follow your doctor's directions on how to take||
2633|041|H|this medication.||
2633|042|H|   The dosage is based on your medical condition, age, weight,||
2633|043|H|response to treatment, and other medications you may be taking.||
2633|044|H|Be sure to tell your doctor and pharmacist about all the products||
2633|045|H|you use (including prescription drugs, nonprescription drugs, and||
2633|046|H|herbal products).||
2633|047|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2633|048|H|using this medication unless your doctor or pharmacist says you||
2633|049|H|may do so safely. Grapefruit can increase the chance of side||
2633|050|H|effects with this medicine. Ask your doctor or pharmacist for||
2633|051|H|more details.||
2633|052|H|   Use this medication regularly to get the most benefit from it.||
2633|053|H|To help you remember, take it at the same time each day.||
2633|054|H|   Do not increase your dose or use this drug more often or for||
2633|055|H|longer than prescribed. Your condition will not improve any||
2633|056|H|faster, and your risk of side effects will increase.||
2633|057|H|   Tell your doctor if you do not get better or if you get worse.||
2633|058|B|||
2633|059|S|SIDE EFFECTS:  See also Warning section.||
2633|060|S|   Headache, cold symptoms (such as stuffy/runny nose, cough), or||
2633|061|S|tiredness may occur. If any of these effects last or get worse,||
2633|062|S|tell your doctor or pharmacist promptly.||
2633|063|S|   Remember that this medication has been prescribed because your||
2633|064|S|doctor has judged that the benefit to you is greater than the||
2633|065|S|risk of side effects. Many people using this medication do not||
2633|066|S|have serious side effects.||
2633|067|S|   This medication may rarely cause increased pressure around the||
2633|068|S|brain (intracranial hypertension-IH). Get medical help right away||
2633|069|S|if any of these very serious side effects occur: nausea/vomiting||
2633|070|S|that doesn't stop, headache that is severe or doesn't go away,||
2633|071|S|vision changes (such as blurred/double vision, decreased vision).||
2633|072|S|   This medication can commonly cause a rash (especially in||
2633|073|S|females) that is usually not serious. However, you may not be||
2633|074|S|able to tell it apart from a rare rash that could be a sign of a||
2633|075|S|severe reaction. Get medical help right away if you develop any||
2633|076|S|rash.||
2633|077|S|   A very serious allergic reaction to this drug is rare.||
2633|078|S|However, get medical help right away if you notice any symptoms||
2633|079|S|of a serious allergic reaction, including: rash, itching/swelling||
2633|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2633|081|S|breathing.||
2633|082|S|   This is not a complete list of possible side effects. If you||
2633|083|S|notice other effects not listed above, contact your doctor or||
2633|084|S|pharmacist.||
2633|085|S|   In the US -||
2633|086|S|   Call your doctor for medical advice about side effects. You||
2633|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2633|088|S|www.fda.gov/medwatch.||
2633|089|S|   In Canada - Call your doctor for medical advice about side||
2633|090|S|effects. You may report side effects to Health Canada at||
2633|091|S|1-866-234-2345.||
2633|092|B|||
2633|093|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2633|094|P|pharmacist if you are allergic to vanzacaftor, tezacaftor, or||
2633|095|P|deutivacaftor; or if you have any other allergies. This||
2633|096|P|medication may contain inactive ingredients, which can cause||
2633|097|P|allergic reactions or other problems. Talk to your pharmacist for||
2633|098|P|more details.||
2633|099|P|   Before using this medication, tell your doctor or pharmacist||
2633|100|P|your medical history, especially of: liver disease, kidney||
2633|101|P|disease.||
2633|102|P|   Before having surgery, tell your doctor or dentist about all||
2633|103|P|the products you use (including prescription drugs,||
2633|104|P|nonprescription drugs, and herbal products).||
2633|105|P|   During pregnancy, this medication should be used only when||
2633|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
2633|107|P|   It is unknown if this medication passes into breast milk.||
2633|108|P|Consult your doctor before breastfeeding.||
2633|109|B|||
2633|110|I|DRUG INTERACTIONS:  See also How to Use section.||
2633|111|I|   Drug interactions may change how your medications work or||
2633|112|I|increase your risk for serious side effects. This document does||
2633|113|I|not contain all possible drug interactions. Keep a list of all||
2633|114|I|the products you use (including prescription/nonprescription||
2633|115|I|drugs and herbal products) and share it with your doctor and||
2633|116|I|pharmacist. Do not start, stop, or change the dosage of any||
2633|117|I|medicines without your doctor's approval.||
2633|118|I|   Other medications can affect the removal of vanzacaftor,||
2633|119|I|tezacaftor, and deutivacaftor from your body, which may affect||
2633|120|I|how this medication works. Examples include mifepristone,||
2633|121|I|rifamycins (such as rifampin, rifabutin), drugs for seizures||
2633|122|I|(such as carbamazepine, phenytoin), St. John's wort, among||
2633|123|I|others.||
2633|124|B|||
2633|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2633|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2633|127|O|poison control center right away. US residents can call||
2633|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2633|129|B|||
2633|130|N|NOTES:  Do not share this medication with others.||
2633|131|N|   Lab and/or medical tests (such as CFTR gene testing,||
2633|132|N|liver/lung function, eye exams) should be done before you start||
2633|133|N|taking this medication and while you are taking it. Keep all||
2633|134|N|medical and lab appointments.||
2633|135|B|||
2633|136|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2633|137|D|remember. If it is more than 6 hours after the missed dose, skip||
2633|138|D|the missed dose. Take your next dose at the regular time. Do not||
2633|139|D|double the dose to catch up.||
2633|140|B|||
2633|141|R|STORAGE:  Store at room temperature away from light and moisture.||
2633|142|R|Do not store in the bathroom. Keep all medications away from||
2633|143|R|children and pets.||
2633|144|R|   Do not flush medications down the toilet or pour them into a||
2633|145|R|drain unless instructed to do so. Properly discard this product||
2633|146|R|when it is expired or no longer needed. Consult your pharmacist||
2633|147|R|or local waste disposal company.||
2633|148|B|||
2633|149|A|Information last revised September 2025.||
2633|150|A|Copyright(c) 2025 First Databank, Inc.||
2633|151|B|||
2634|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2634|002|Z|does NOT have all possible information about this product. This||
2634|003|Z|information does not assure that this product is safe, effective,||
2634|004|Z|or appropriate for you. This information is not individual||
2634|005|Z|medical advice and does not substitute for the advice of your||
2634|006|Z|health care professional. Always ask your health care||
2634|007|Z|professional for complete information about this product and your||
2634|008|Z|specific health needs.||
2634|009|B|||
2634|010|T|ZENOCUTUZUMAB - INJECTION||
2634|011|F|(ZEN-oh-CUT-oh-ZOO-mab)||
2634|012|B|||
2634|013|C|COMMON BRAND NAME(S): Bizengri||
2634|014|B|||
2634|015|W|WARNING:  Zenocutuzumab can cause serious (possibly fatal) harm||
2634|016|W|to an unborn baby if used during pregnancy. Discuss reliable||
2634|017|W|forms of birth control with your doctor. See also Precautions||
2634|018|W|section.||
2634|019|B|||
2634|020|U|USES:  This medication is used to treat certain types of cancer||
2634|021|U|(such as lung, pancreas). Zenocutuzumab belongs to a class of||
2634|022|U|drugs known as monoclonal antibodies. Zenocutuzumab works by||
2634|023|U|slowing or stopping the growth of cancer cells.||
2634|024|B|||
2634|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2634|026|H|from your pharmacist before you start using zenocutuzumab and||
2634|027|H|each time you get a treatment. If you have any questions, ask||
2634|028|H|your doctor or pharmacist.||
2634|029|H|   This medication is given by a health care professional. It is||
2634|030|H|injected slowly into a vein over 4 hours. It is given as directed||
2634|031|H|by your doctor, usually once every 2 weeks.||
2634|032|H|   Infusion reactions may happen during the infusion of this drug||
2634|033|H|and for some time afterward. Your doctor may prescribe other||
2634|034|H|medications (such as acetaminophen, antihistamines,||
2634|035|H|corticosteroids) before each treatment to help prevent these side||
2634|036|H|effects. Tell your doctor right away if you have any symptoms of||
2634|037|H|infusion reactions such as chills, shaking, nausea, vomiting,||
2634|038|H|diarrhea, back/neck pain, numbness, tingling, fever, or cough.||
2634|039|H|Your doctor may give you other medications to help with these||
2634|040|H|side effects or may slow down or stop your treatment for some||
2634|041|H|time.||
2634|042|H|   Use this medication regularly to get the most benefit from it.||
2634|043|H|To help you remember, mark your calendar with a reminder.||
2634|044|B|||
2634|045|S|SIDE EFFECTS:  See also How to Use section.||
2634|046|S|   Diarrhea, muscle/bone pain, constipation, tiredness, nausea,||
2634|047|S|vomiting, or abdominal pain may occur. If any of these effects||
2634|048|S|last or get worse, tell your doctor or pharmacist promptly.||
2634|049|S|   Remember that this medication has been prescribed because your||
2634|050|S|doctor has judged that the benefit to you is greater than the||
2634|051|S|risk of side effects. Many people using this medication do not||
2634|052|S|have serious side effects.||
2634|053|S|   Tell your doctor right away if you have any serious side||
2634|054|S|effects, including: signs of new or worsening lung problems (such||
2634|055|S|as shortness of breath, cough, fever), signs of heart problems||
2634|056|S|(such as swelling ankles/feet, unusual tiredness, unusual/sudden||
2634|057|S|weight gain).||
2634|058|S|   A very serious allergic reaction to this drug is rare.||
2634|059|S|However, get medical help right away if you notice any symptoms||
2634|060|S|of a serious allergic reaction, including: rash, itching/swelling||
2634|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2634|062|S|breathing.||
2634|063|S|   This is not a complete list of possible side effects. If you||
2634|064|S|notice other effects not listed above, contact your doctor or||
2634|065|S|pharmacist.||
2634|066|S|   In the US -||
2634|067|S|   Call your doctor for medical advice about side effects. You||
2634|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2634|069|S|www.fda.gov/medwatch.||
2634|070|S|   In Canada - Call your doctor for medical advice about side||
2634|071|S|effects. You may report side effects to Health Canada at||
2634|072|S|1-866-234-2345.||
2634|073|B|||
2634|074|P|PRECAUTIONS:  Before using zenocutuzumab, tell your doctor or||
2634|075|P|pharmacist if you are allergic to it; or if you have any other||
2634|076|P|allergies. This product may contain inactive ingredients, which||
2634|077|P|can cause allergic reactions or other problems. Talk to your||
2634|078|P|pharmacist for more details.||
2634|079|P|   Before using this medication, tell your doctor or pharmacist||
2634|080|P|your medical history, especially of: heart disease (such as heart||
2634|081|P|failure), other lung/breathing problems.||
2634|082|P|   Before having surgery, tell your doctor or dentist about all||
2634|083|P|the products you use (including prescription drugs,||
2634|084|P|nonprescription drugs, and herbal products).||
2634|085|P|   Tell your doctor if you are pregnant or plan to become||
2634|086|P|pregnant. You should not become pregnant while using||
2634|087|P|zenocutuzumab. Zenocutuzumab may harm an unborn baby. Your doctor||
2634|088|P|should order a pregnancy test before you start this medication.||
2634|089|P|Ask about reliable forms of birth control while using this||
2634|090|P|medication and for 2 months after the last dose. If you become||
2634|091|P|pregnant, talk to your doctor right away about the risks and||
2634|092|P|benefits of this medication.||
2634|093|P|   It is unknown if this medication passes into breast milk.||
2634|094|P|Consult your doctor before breastfeeding.||
2634|095|B|||
2634|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2634|097|I|medications work or increase your risk for serious side effects.||
2634|098|I|This document does not contain all possible drug interactions.||
2634|099|I|Keep a list of all the products you use (including||
2634|100|I|prescription/nonprescription drugs and herbal products) and share||
2634|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
2634|102|I|the dosage of any medicines without your doctor's approval.||
2634|103|B|||
2634|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2634|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2634|106|O|poison control center right away. US residents can call||
2634|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2634|108|B|||
2634|109|N|NOTES:  Lab and/or medical tests (such as heart function) should||
2634|110|N|be done before you start using this medication and while you are||
2634|111|N|using it. Keep all medical and lab appointments. Consult your||
2634|112|N|doctor for more details.||
2634|113|B|||
2634|114|D|MISSED DOSE:  It is important to get each dose of this medication||
2634|115|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2634|116|D|right away for a new dosing schedule.||
2634|117|B|||
2634|118|R|STORAGE:  Not applicable. This medication is given in a hospital||
2634|119|R|or clinic and will not be stored at home.||
2634|120|B|||
2634|121|A|Information last revised January 2025.||
2634|122|A|Copyright(c) 2025 First Databank, Inc.||
2634|123|B|||
2635|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2635|002|Z|does NOT have all possible information about this product. This||
2635|003|Z|information does not assure that this product is safe, effective,||
2635|004|Z|or appropriate for you. This information is not individual||
2635|005|Z|medical advice and does not substitute for the advice of your||
2635|006|Z|health care professional. Always ask your health care||
2635|007|Z|professional for complete information about this product and your||
2635|008|Z|specific health needs.||
2635|009|B|||
2635|010|T|OLEZARSEN - INJECTION||
2635|011|F|(oh-LEH-zar-sen)||
2635|012|B|||
2635|013|C|COMMON BRAND NAME(S): Tryngolza||
2635|014|B|||
2635|015|U|USES:  Olezarsen is used along with a proper diet to help lower||
2635|016|U|fats (triglycerides) in the blood. It is used by people who have||
2635|017|U|a certain inherited condition (familial chylomicronemia syndrome)||
2635|018|U|that causes high levels of triglycerides in the blood. Olezarsen||
2635|019|U|works by improving how well your body gets rid of triglycerides.||
2635|020|B|||
2635|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2635|022|H|Instructions for Use if available from your pharmacist before you||
2635|023|H|start using olezarsen and each time you get a refill. Ask your||
2635|024|H|health care professional how to prepare and use this medication.||
2635|025|H|If you have any questions, ask your doctor or pharmacist.||
2635|026|H|   Inject this medication under the skin as directed by your||
2635|027|H|doctor, usually once a month. The injection is given in the upper||
2635|028|H|arms, thighs, or abdomen (except for a 2-inch area around your||
2635|029|H|belly button).||
2635|030|H|   Take the medication out of the refrigerator at least 30||
2635|031|H|minutes before you inject it to allow it to reach room||
2635|032|H|temperature. Do not warm up this medication any other way (for||
2635|033|H|example, do not heat it in the microwave, place it in hot water,||
2635|034|H|or leave it in direct sunlight). Before using, check this product||
2635|035|H|for cloudiness, particles, or discoloration. If you see any of||
2635|036|H|these things, do not use the liquid. Before injecting each dose,||
2635|037|H|clean the skin you are going to inject into (the injection site)||
2635|038|H|with rubbing alcohol. Change the injection site each time to||
2635|039|H|lessen injury under the skin. Do not inject into skin that is||
2635|040|H|red, swollen, or scarred. To lessen bruising, do not rub the||
2635|041|H|injection site after a shot. Learn how to store and discard||
2635|042|H|medical supplies safely.||
2635|043|H|   Use this medication regularly to get the most benefit from it.||
2635|044|H|To help you remember, mark your calendar with a reminder.||
2635|045|B|||
2635|046|S|SIDE EFFECTS:  Joint pain or redness/pain at the injection site||
2635|047|S|may occur. If any of these effects last or get worse, tell your||
2635|048|S|doctor or pharmacist promptly.||
2635|049|S|   Remember that this medication has been prescribed because your||
2635|050|S|doctor has judged that the benefit to you is greater than the||
2635|051|S|risk of side effects. Many people using this medication do not||
2635|052|S|have serious side effects.||
2635|053|S|   A very serious allergic reaction to this drug is rare.||
2635|054|S|However, get medical help right away if you notice any symptoms||
2635|055|S|of a serious allergic reaction, including: rash, itching/swelling||
2635|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2635|057|S|breathing.||
2635|058|S|   This is not a complete list of possible side effects. If you||
2635|059|S|notice other effects not listed above, contact your doctor or||
2635|060|S|pharmacist.||
2635|061|S|   In the US -||
2635|062|S|   Call your doctor for medical advice about side effects. You||
2635|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2635|064|S|www.fda.gov/medwatch.||
2635|065|S|   In Canada - Call your doctor for medical advice about side||
2635|066|S|effects. You may report side effects to Health Canada at||
2635|067|S|1-866-234-2345.||
2635|068|B|||
2635|069|P|PRECAUTIONS:  Before using olezarsen, tell your doctor or||
2635|070|P|pharmacist if you are allergic to it; or if you have any other||
2635|071|P|allergies. This product may contain inactive ingredients, which||
2635|072|P|can cause allergic reactions or other problems. Talk to your||
2635|073|P|pharmacist for more details.||
2635|074|P|   Before using this medication, tell your doctor or pharmacist||
2635|075|P|your medical history.||
2635|076|P|   Before having surgery, tell your doctor or dentist about all||
2635|077|P|the products you use (including prescription drugs,||
2635|078|P|nonprescription drugs, and herbal products).||
2635|079|P|   During pregnancy, this medication should be used only when||
2635|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
2635|081|P|   It is unknown if this medication passes into breast milk.||
2635|082|P|Consult your doctor before breastfeeding.||
2635|083|B|||
2635|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2635|085|I|medications work or increase your risk for serious side effects.||
2635|086|I|This document does not contain all possible drug interactions.||
2635|087|I|Keep a list of all the products you use (including||
2635|088|I|prescription/nonprescription drugs and herbal products) and share||
2635|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
2635|090|I|the dosage of any medicines without your doctor's approval.||
2635|091|B|||
2635|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2635|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2635|094|O|poison control center right away. US residents can call||
2635|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2635|096|B|||
2635|097|N|NOTES:  Do not share this medication with others.||
2635|098|N|   Lab and/or medical tests (such as triglyceride levels) should||
2635|099|N|be done before you start using this medication and while you are||
2635|100|N|using it. Keep all medical and lab appointments. Consult your||
2635|101|N|doctor for more details.||
2635|102|B|||
2635|103|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2635|104|D|Then use your next dose one month later. Continue to use each||
2635|105|D|dose one month apart. Do not double the dose to catch up. Ask||
2635|106|D|your doctor or pharmacist if you have questions about your dosing||
2635|107|D|schedule.||
2635|108|B|||
2635|109|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2635|110|R|medication in the original packaging to protect from light. This||
2635|111|R|medication may also be stored at room temperature if needed. If||
2635|112|R|the medication is stored at room temperature, discard after 6||
2635|113|R|weeks. Keep all medications away from children and pets.||
2635|114|R|   Do not flush medications down the toilet or pour them into a||
2635|115|R|drain unless instructed to do so. Properly discard this product||
2635|116|R|when it is expired or no longer needed. Consult your pharmacist||
2635|117|R|or local waste disposal company.||
2635|118|B|||
2635|119|A|Information last revised January 2025.||
2635|120|A|Copyright(c) 2025 First Databank, Inc.||
2635|121|B|||
2636|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2636|002|Z|does NOT have all possible information about this product. This||
2636|003|Z|information does not assure that this product is safe, effective,||
2636|004|Z|or appropriate for you. This information is not individual||
2636|005|Z|medical advice and does not substitute for the advice of your||
2636|006|Z|health care professional. Always ask your health care||
2636|007|Z|professional for complete information about this product and your||
2636|008|Z|specific health needs.||
2636|009|B|||
2636|010|T|CRINECERFONT - ORAL||
2636|011|F|(CRY-ness-ER-font)||
2636|012|B|||
2636|013|C|COMMON BRAND NAME(S): Crenessity||
2636|014|B|||
2636|015|U|USES:  This medication is used with a corticosteroid medication||
2636|016|U|to control androgen levels in people with a certain adrenal gland||
2636|017|U|problem (classic congenital adrenal hyperplasia - CAH).||
2636|018|B|||
2636|019|H|HOW TO USE:  Read the Patient Information Leaflet and||
2636|020|H|Instructions for Use if available from your pharmacist before you||
2636|021|H|start taking crinecerfont and each time you get a refill. If you||
2636|022|H|have any questions, ask your doctor or pharmacist.||
2636|023|H|   Take this medication by mouth with a meal as directed by your||
2636|024|H|doctor, usually twice daily (in the morning and evening). The||
2636|025|H|dosage is based on your medical condition and other medications||
2636|026|H|you may be taking. Be sure to tell your doctor and pharmacist||
2636|027|H|about all the products you use (including prescription drugs,||
2636|028|H|nonprescription drugs, and herbal products). Children's dosage is||
2636|029|H|also based on weight.||
2636|030|H|   Swallow the capsules whole. If you are using the liquid form||
2636|031|H|of this medication, carefully measure the dose using a special||
2636|032|H|measuring device. Do not use a household spoon because you may||
2636|033|H|not get the correct dose.||
2636|034|H|   Use this medication regularly to get the most benefit from it.||
2636|035|H|To help you remember, take it at the same times each day.||
2636|036|H|   It is very important to keep taking this medication (and the||
2636|037|H|corticosteroid medication) exactly as prescribed by your doctor.||
2636|038|H|Do not skip any doses.||
2636|039|B|||
2636|040|S|SIDE EFFECTS:  Tiredness, headache, dizziness, back/joint pain,||
2636|041|S|abdominal/stomach pain, stuffy nose, or decreased appetite may||
2636|042|S|occur. If any of these effects last or get worse, tell your||
2636|043|S|doctor or pharmacist promptly.||
2636|044|S|   Remember that this medication has been prescribed because your||
2636|045|S|doctor has judged that the benefit to you is greater than the||
2636|046|S|risk of side effects. Many people using this medication do not||
2636|047|S|have serious side effects.||
2636|048|S|   A very serious allergic reaction to this drug is rare.||
2636|049|S|However, get medical help right away if you notice any symptoms||
2636|050|S|of a serious allergic reaction, including: rash, itching/swelling||
2636|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2636|052|S|breathing.||
2636|053|S|   This is not a complete list of possible side effects. If you||
2636|054|S|notice other effects not listed above, contact your doctor or||
2636|055|S|pharmacist.||
2636|056|S|   In the US -||
2636|057|S|   Call your doctor for medical advice about side effects. You||
2636|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2636|059|S|www.fda.gov/medwatch.||
2636|060|S|   In Canada - Call your doctor for medical advice about side||
2636|061|S|effects. You may report side effects to Health Canada at||
2636|062|S|1-866-234-2345.||
2636|063|B|||
2636|064|P|PRECAUTIONS:  Before taking crinecerfont, tell your doctor or||
2636|065|P|pharmacist if you are allergic to it; or if you have any other||
2636|066|P|allergies. This product may contain inactive ingredients, which||
2636|067|P|can cause allergic reactions or other problems. Talk to your||
2636|068|P|pharmacist for more details.||
2636|069|P|   Before using this medication, tell your doctor or pharmacist||
2636|070|P|your medical history, especially of: kidney disease.||
2636|071|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2636|072|P|can make you more dizzy. Do not drive, use machinery, or do||
2636|073|P|anything that needs alertness until you can do it safely. Limit||
2636|074|P|alcoholic beverages. Talk to your doctor if you are using||
2636|075|P|marijuana (cannabis).||
2636|076|P|   Before having surgery, tell your doctor or dentist about all||
2636|077|P|the products you use (including prescription drugs,||
2636|078|P|nonprescription drugs, and herbal products).||
2636|079|P|   During pregnancy, this medication should be used only when||
2636|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
2636|081|P|   It is unknown if this medication passes into breast milk.||
2636|082|P|Consult your doctor before breastfeeding.||
2636|083|B|||
2636|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2636|085|I|medications work or increase your risk for serious side effects.||
2636|086|I|This document does not contain all possible drug interactions.||
2636|087|I|Keep a list of all the products you use (including||
2636|088|I|prescription/nonprescription drugs and herbal products) and share||
2636|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
2636|090|I|the dosage of any medicines without your doctor's approval.||
2636|091|B|||
2636|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2636|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2636|094|O|poison control center right away. US residents can call||
2636|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2636|096|B|||
2636|097|N|NOTES:  Do not share this medication with others.||
2636|098|N|   Lab and/or medical tests (such as androgen levels, complete||
2636|099|N|blood count) should be done while you are taking this medication.||
2636|100|N|Keep all medical and lab appointments. Consult your doctor for||
2636|101|N|more details.||
2636|102|B|||
2636|103|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
2636|104|D|(even if it is near the time of the next dose). Take your next||
2636|105|D|dose at the regular time.||
2636|106|B|||
2636|107|R|STORAGE:  Store the capsules at room temperature away from light||
2636|108|R|and moisture. Do not store in the bathroom. Store the liquid form||
2636|109|R|upright in the original bottle. Store the unopened liquid bottle||
2636|110|R|in the refrigerator. Do not freeze. Store the opened liquid||
2636|111|R|bottle in the refrigerator or at room temperature and use within||
2636|112|R|30 days after opening. Keep all medications away from children||
2636|113|R|and pets.||
2636|114|R|   Do not flush medications down the toilet or pour them into a||
2636|115|R|drain unless instructed to do so. Properly discard this product||
2636|116|R|when it is expired or no longer needed. Consult your pharmacist||
2636|117|R|or local waste disposal company.||
2636|118|B|||
2636|119|A|Information last revised January 2025.||
2636|120|A|Copyright(c) 2025 First Databank, Inc.||
2636|121|B|||
2637|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2637|002|Z|does NOT have all possible information about this product. This||
2637|003|Z|information does not assure that this product is safe, effective,||
2637|004|Z|or appropriate for you. This information is not individual||
2637|005|Z|medical advice and does not substitute for the advice of your||
2637|006|Z|health care professional. Always ask your health care||
2637|007|Z|professional for complete information about this product and your||
2637|008|Z|specific health needs.||
2637|009|B|||
2637|010|T|NIVOLUMAB/HYALURONIDASE - SUBCUTANEOUS INJECTION||
2637|011|F|(nye-VOL-ue-mab/HYE-al-ure-ON-i-dase)||
2637|012|B|||
2637|013|C|COMMON BRAND NAME(S): Opdivo Qvantig||
2637|014|B|||
2637|015|U|USES:  This medication is used to treat various types of cancer.||
2637|016|U|It contains 2 ingredients: nivolumab and hyaluronidase. Nivolumab||
2637|017|U|belongs to a class of drugs known as monoclonal antibodies. It||
2637|018|U|works by helping your immune system fight the cancer.||
2637|019|U|Hyaluronidase is used to help the body absorb nivolumab, which||
2637|020|U|helps it work better.||
2637|021|B|||
2637|022|H|HOW TO USE:  Read the Medication Guide provided by your||
2637|023|H|pharmacist before you start using nivolumab/hyaluronidase and||
2637|024|H|each time you get a treatment. If you have any questions, ask||
2637|025|H|your doctor or pharmacist.||
2637|026|H|   This medication is given by injection under the skin by a||
2637|027|H|health care professional. It is injected slowly into the abdomen||
2637|028|H|or thigh over 3 to 5 minutes. It is given as directed by your||
2637|029|H|doctor, usually once every 2 to 4 weeks.||
2637|030|H|   Use this medication regularly to get the most benefit from it.||
2637|031|H|To help you remember, mark your calendar with a reminder.||
2637|032|B|||
2637|033|S|SIDE EFFECTS:  Injection site reactions (such as redness, pain,||
2637|034|S|swelling), nausea, diarrhea, constipation, loss of appetite,||
2637|035|S|headache, bone/muscle pain, or tiredness may occur. If any of||
2637|036|S|these effects last or get worse, tell your doctor or pharmacist||
2637|037|S|promptly.||
2637|038|S|   People using this medication may have serious side effects.||
2637|039|S|However, you have been prescribed this drug because your doctor||
2637|040|S|has judged that the benefit to you is greater than the risk of||
2637|041|S|side effects. Careful monitoring by your doctor may decrease your||
2637|042|S|risk.||
2637|043|S|   Tell your doctor right away if you have any serious side||
2637|044|S|effects, including: new/worsening cough, diarrhea with||
2637|045|S|blood/mucus, mouth/throat sores, symptoms of liver disease (such||
2637|046|S|as nausea/vomiting that doesn't stop, stomach/abdominal pain,||
2637|047|S|yellowing eyes/skin, dark urine), signs of kidney problems (such||
2637|048|S|as change in the amount of urine, pink/bloody urine), easy||
2637|049|S|bruising/bleeding, swelling hands/ankles/feet, unusual weakness,||
2637|050|S|joint stiffness/pain, muscle||
2637|051|S|weakness/tenderness/pain/spasms/cramps, numbness/tingling of||
2637|052|S|arms/legs, loss of coordination, eye redness/pain, sensitivity to||
2637|053|S|light, vision changes.||
2637|054|S|   This medication may cause hormone gland problems (such as||
2637|055|S|thyroid, pituitary, adrenal, pancreas). Your body could make too||
2637|056|S|much or too little hormone. Tell your doctor right away if you||
2637|057|S|have any symptoms such as: cold or heat intolerance, unexplained||
2637|058|S|weight loss/gain, increased thirst/urination, mood or behavior||
2637|059|S|changes (such as decreased sex drive, irritability,||
2637|060|S|forgetfulness), slow/fast/pounding/irregular heartbeat.||
2637|061|S|   Get medical help right away if you have any very serious side||
2637|062|S|effects, including: chest pain, shortness of breath.||
2637|063|S|   This medication can commonly cause itching or a rash that is||
2637|064|S|usually not serious. However, you may not be able to tell it||
2637|065|S|apart from a rare rash that could be a sign of a severe reaction.||
2637|066|S|Get medical help right away if you develop any rash or itching.||
2637|067|S|   A very serious allergic reaction to this drug is rare.||
2637|068|S|However, get medical help right away if you notice any symptoms||
2637|069|S|of a serious allergic reaction, including: fever, swollen lymph||
2637|070|S|nodes, rash, itching/swelling (especially of the||
2637|071|S|face/tongue/throat), severe dizziness, trouble breathing.||
2637|072|S|   This is not a complete list of possible side effects. If you||
2637|073|S|notice other effects not listed above, contact your doctor or||
2637|074|S|pharmacist.||
2637|075|S|   In the US -||
2637|076|S|   Call your doctor for medical advice about side effects. You||
2637|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2637|078|S|www.fda.gov/medwatch.||
2637|079|S|   In Canada - Call your doctor for medical advice about side||
2637|080|S|effects. You may report side effects to Health Canada at||
2637|081|S|1-866-234-2345.||
2637|082|B|||
2637|083|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2637|084|P|pharmacist if you are allergic to nivolumab or hyaluronidase; or||
2637|085|P|if you have any other allergies. This product may contain||
2637|086|P|inactive ingredients, which can cause allergic reactions or other||
2637|087|P|problems. Talk to your pharmacist for more details.||
2637|088|P|   Before using this medication, tell your doctor or pharmacist||
2637|089|P|your medical history, especially of: immune system problems (such||
2637|090|P|as Crohn's disease, ulcerative colitis, lupus), organ transplant,||
2637|091|P|stem cell transplant with donor cells, radiation treatment,||
2637|092|P|nervous system disorders (such as myasthenia gravis,||
2637|093|P|Guillain-Barre syndrome).||
2637|094|P|   Before having surgery, tell your doctor or dentist about all||
2637|095|P|the products you use (including prescription drugs,||
2637|096|P|nonprescription drugs, and herbal products).||
2637|097|P|   Tell your doctor if you are pregnant or plan to become||
2637|098|P|pregnant. You should not become pregnant while using nivolumab.||
2637|099|P|Nivolumab may harm an unborn baby. Your doctor should order a||
2637|100|P|pregnancy test before you start this medication. Ask about||
2637|101|P|reliable forms of birth control while using this medication and||
2637|102|P|for 5 months after the last dose. If you become pregnant, talk to||
2637|103|P|your doctor right away about the risks and benefits of this||
2637|104|P|medication.||
2637|105|P|   It is unknown if this drug passes into breast milk. Because of||
2637|106|P|the possible risk to the infant, breastfeeding is not recommended||
2637|107|P|while using this drug and for 5 months after the last dose.||
2637|108|P|Consult your doctor before breastfeeding.||
2637|109|B|||
2637|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2637|111|I|medications work or increase your risk for serious side effects.||
2637|112|I|This document does not contain all possible drug interactions.||
2637|113|I|Keep a list of all the products you use (including||
2637|114|I|prescription/nonprescription drugs and herbal products) and share||
2637|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
2637|116|I|the dosage of any medicines without your doctor's approval.||
2637|117|B|||
2637|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2637|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2637|120|O|poison control center right away. US residents can call||
2637|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2637|122|B|||
2637|123|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
2637|124|N|function, blood sugar) should be done before and during treatment||
2637|125|N|with this medication. Keep all medical and lab appointments.||
2637|126|N|Consult your doctor for more details.||
2637|127|B|||
2637|128|D|MISSED DOSE:  It is important to get each dose of this medication||
2637|129|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2637|130|D|right away for a new dosing schedule.||
2637|131|B|||
2637|132|R|STORAGE:  Not applicable. This medication is given in a hospital||
2637|133|R|or clinic and will not be stored at home.||
2637|134|B|||
2637|135|A|Information last revised January 2025.||
2637|136|A|Copyright(c) 2025 First Databank, Inc.||
2637|137|B|||
2638|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2638|002|Z|does NOT have all possible information about this product. This||
2638|003|Z|information does not assure that this product is safe, effective,||
2638|004|Z|or appropriate for you. This information is not individual||
2638|005|Z|medical advice and does not substitute for the advice of your||
2638|006|Z|health care professional. Always ask your health care||
2638|007|Z|professional for complete information about this product and your||
2638|008|Z|specific health needs.||
2638|009|B|||
2638|010|T|CONCIZUMAB - INJECTION||
2638|011|F|(kon-SIZ-ue-mab)||
2638|012|B|||
2638|013|C|COMMON BRAND NAME(S): Alhemo||
2638|014|B|||
2638|015|U|USES:  This medication is used by people with a certain inherited||
2638|016|U|bleeding problem (hemophilia A or B) to help prevent or lessen||
2638|017|U|how often you have bleeding problems. Concizumab belongs to a||
2638|018|U|class of medications known as monoclonal antibodies. It works by||
2638|019|U|helping your blood to clot normally, which helps prevent bleeding||
2638|020|U|due to hemophilia.||
2638|021|B|||
2638|022|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2638|023|H|provided by your pharmacist before you start using this||
2638|024|H|medication and each time you get a refill. Ask your health care||
2638|025|H|professional how to prepare and use this medication. If you have||
2638|026|H|any questions, ask your doctor or pharmacist.||
2638|027|H|   Inject this medication under the skin as directed by your||
2638|028|H|doctor, usually daily. The injection is given in the thighs or||
2638|029|H|abdomen (except for a 2-inch area around your belly button). The||
2638|030|H|dosage is based on your medical condition, weight, and response||
2638|031|H|to treatment.||
2638|032|H|   Stop the prophylactic use of bypassing agents 1 to 2 days||
2638|033|H|before starting concizumab. Ask your healthcare professional for||
2638|034|H|more information about the use of these other products and what||
2638|035|H|to do if you have breakthrough bleeding.||
2638|036|H|   This product may contain clear or white particles. Before||
2638|037|H|using, check this product for cloudiness, large particles, or||
2638|038|H|discoloration. If you see any of these things, do not use the||
2638|039|H|liquid. Before injecting each dose, clean the skin you are going||
2638|040|H|to inject into (the injection site) with rubbing alcohol. Change||
2638|041|H|the injection site each time to lessen injury under the skin. Do||
2638|042|H|not inject into moles, scars, stretch marks, or skin that is||
2638|043|H|tender, bruised, red, or hard. To lessen bruising, do not rub the||
2638|044|H|injection site after a shot. Learn how to store and discard||
2638|045|H|medical supplies safely.||
2638|046|H|   Use this medication regularly to get the most benefit from it.||
2638|047|H|To help you remember, use it at the same time each day.||
2638|048|H|   Do not increase your dose or use this drug more often or for||
2638|049|H|longer than prescribed. Your condition will not improve any||
2638|050|H|faster, and your risk of side effects will increase.||
2638|051|H|   Tell your doctor if your condition does not get better or if||
2638|052|H|it gets worse.||
2638|053|B|||
2638|054|S|SIDE EFFECTS:  Redness, itching, swelling, bruising, or pain at||
2638|055|S|the injection site may occur. If any of these effects last or get||
2638|056|S|worse, tell your doctor or pharmacist promptly.||
2638|057|S|   Remember that this medication has been prescribed because your||
2638|058|S|doctor has judged that the benefit to you is greater than the||
2638|059|S|risk of side effects. Many people using this medication do not||
2638|060|S|have serious side effects.||
2638|061|S|   This medication may rarely cause serious problems from blood||
2638|062|S|clots (such as pulmonary embolism, stroke, heart attack, deep||
2638|063|S|vein thrombosis). You may be at increased risk for blood clots if||
2638|064|S|you are also using other products (such as Factor VIII or IX for||
2638|065|S|breakthrough bleeding), have a history of heart/blood vessel||
2638|066|S|disease, cancer, or if you are immobile (such as on very long||
2638|067|S|plane flights or being bedridden). Get medical help right away if||
2638|068|S|you develop symptoms of serious blood clots, such as shortness of||
2638|069|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
2638|070|S|sweating, confusion, sudden dizziness/fainting,||
2638|071|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2638|072|S|trouble speaking, weakness on one side of the body, sudden vision||
2638|073|S|changes.||
2638|074|S|   A very serious allergic reaction to this drug is rare.||
2638|075|S|However, get medical help right away if you notice any symptoms||
2638|076|S|of a serious allergic reaction, including: rash, itching/swelling||
2638|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2638|078|S|breathing.||
2638|079|S|   This is not a complete list of possible side effects. If you||
2638|080|S|notice other effects not listed above, contact your doctor or||
2638|081|S|pharmacist.||
2638|082|S|   In the US -||
2638|083|S|   Call your doctor for medical advice about side effects. You||
2638|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2638|085|S|www.fda.gov/medwatch.||
2638|086|S|   In Canada - Call your doctor for medical advice about side||
2638|087|S|effects. You may report side effects to Health Canada at||
2638|088|S|1-866-234-2345.||
2638|089|B|||
2638|090|P|PRECAUTIONS:  Before using concizumab, tell your doctor or||
2638|091|P|pharmacist if you are allergic to it; or if you have any other||
2638|092|P|allergies. This product may contain inactive ingredients, which||
2638|093|P|can cause allergic reactions or other problems. Talk to your||
2638|094|P|pharmacist for more details.||
2638|095|P|   Before using this medication, tell your doctor or pharmacist||
2638|096|P|your medical history.||
2638|097|P|   Before having surgery, tell your doctor or dentist about all||
2638|098|P|the products you use (including prescription drugs,||
2638|099|P|nonprescription drugs, and herbal products). Your doctor or||
2638|100|P|dentist may tell you to stop using concizumab before your||
2638|101|P|surgery. Ask for specific instructions about stopping or starting||
2638|102|P|this medication.||
2638|103|P|   Tell your doctor if you are pregnant or plan to become||
2638|104|P|pregnant. You should not become pregnant while using concizumab.||
2638|105|P|Concizumab may harm an unborn baby. Your doctor should order a||
2638|106|P|pregnancy test before you start this medication. Ask about||
2638|107|P|reliable forms of birth control while using this medication and||
2638|108|P|for 7 weeks after the last dose. If you become pregnant, talk to||
2638|109|P|your doctor right away about the risks and benefits of this||
2638|110|P|medication.||
2638|111|P|   It is unknown if this medication passes into breast milk.||
2638|112|P|Consult your doctor before breastfeeding.||
2638|113|B|||
2638|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2638|115|I|medications work or increase your risk for serious side effects.||
2638|116|I|This document does not contain all possible drug interactions.||
2638|117|I|Keep a list of all the products you use (including||
2638|118|I|prescription/nonprescription drugs and herbal products) and share||
2638|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
2638|120|I|the dosage of any medicines without your doctor's approval.||
2638|121|I|   This medication may interfere with certain lab tests (such as||
2638|122|I|blood clotting tests), possibly causing false test results. Make||
2638|123|I|sure lab personnel and all your doctors know you use this drug.||
2638|124|B|||
2638|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2638|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2638|127|O|poison control center right away. US residents can call||
2638|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2638|129|B|||
2638|130|N|NOTES:  Do not share this medication with others.||
2638|131|N|   Lab and/or medical tests (such as blood clotting tests,||
2638|132|N|weight, concizumab blood levels) must be done while you are using||
2638|133|N|this medication. Keep all medical and lab appointments.||
2638|134|B|||
2638|135|D|MISSED DOSE:  It is very important to follow your treatment||
2638|136|D|regimen exactly. Ask your doctor ahead of time what you should do||
2638|137|D|if you miss a dose of concizumab.||
2638|138|B|||
2638|139|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2638|140|R|medication in the original package to protect it from light. Once||
2638|141|R|opened, this medication may also be stored at room temperature if||
2638|142|R|needed and expires after 28 days. Keep all medications away from||
2638|143|R|children and pets.||
2638|144|R|   Do not flush medications down the toilet or pour them into a||
2638|145|R|drain unless instructed to do so. Properly discard this product||
2638|146|R|when it is expired or no longer needed. Consult your pharmacist||
2638|147|R|or local waste disposal company.||
2638|148|B|||
2638|149|M|MEDICAL ALERT:  Your condition can cause complications in a||
2638|150|M|medical emergency. For information about enrolling in MedicAlert,||
2638|151|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2638|152|B|||
2638|153|A|Information last revised January 2025.||
2638|154|A|Copyright(c) 2025 First Databank, Inc.||
2638|155|B|||
2639|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2639|002|Z|does NOT have all possible information about this product. This||
2639|003|Z|information does not assure that this product is safe, effective,||
2639|004|Z|or appropriate for you. This information is not individual||
2639|005|Z|medical advice and does not substitute for the advice of your||
2639|006|Z|health care professional. Always ask your health care||
2639|007|Z|professional for complete information about this product and your||
2639|008|Z|specific health needs.||
2639|009|B|||
2639|010|T|DATOPOTAMAB DERUXTECAN - INJECTION||
2639|011|B|||
2639|012|C|COMMON BRAND NAME(S): Datroway||
2639|013|B|||
2639|014|U|USES:  This medication is used to treat certain types of cancer||
2639|015|U|(such as breast, lung). It works by slowing or stopping the||
2639|016|U|growth of cancer cells.||
2639|017|B|||
2639|018|H|HOW TO USE:  Read the Medication Guide provided by your||
2639|019|H|pharmacist before you start using datopotamab deruxtecan and each||
2639|020|H|time you get a treatment. If you have any questions, ask your||
2639|021|H|doctor or pharmacist.||
2639|022|H|   This medication is given by injection into a vein by a health||
2639|023|H|care professional. It is given as directed by your doctor,||
2639|024|H|usually once every 21 days. The first dose is injected slowly||
2639|025|H|into a vein over 90 minutes. Later doses may be given over 30||
2639|026|H|minutes. The dosage is based on your medical condition, weight,||
2639|027|H|and response to treatment.||
2639|028|H|   Infusion reactions may happen during the infusion of this drug||
2639|029|H|and for some time afterward. Your doctor may prescribe other||
2639|030|H|medications (such as acetaminophen, antihistamines, drugs used to||
2639|031|H|treat nausea) before each treatment to help prevent these side||
2639|032|H|effects. Tell your doctor right away if you have any symptoms of||
2639|033|H|infusion reactions such as cough, wheezing, nausea, or vomiting.||
2639|034|H|Your doctor may give you other medications to help with these||
2639|035|H|side effects or may slow down or stop your treatment for some||
2639|036|H|time.||
2639|037|H|   Use this medication regularly to get the most benefit from it.||
2639|038|H|To help you remember, mark your calendar with a reminder.||
2639|039|B|||
2639|040|S|SIDE EFFECTS:  See also How to Use section.||
2639|041|S|   Dry eye, tiredness, hair loss, muscle/joint pain,||
2639|042|S|constipation, nausea, or vomiting may occur. Nausea and vomiting||
2639|043|S|can be severe. In some cases, your doctor may prescribe||
2639|044|S|medication to prevent or relieve nausea and vomiting. Eating||
2639|045|S|several small meals, not eating before treatment, or limiting||
2639|046|S|activity may help lessen some of these effects. If any of these||
2639|047|S|effects last or get worse, tell your doctor or pharmacist||
2639|048|S|promptly.||
2639|049|S|   To prevent or treat dry eyes, your doctor may direct you to||
2639|050|S|use an eye lubricant, such as artificial tears. Ask your doctor||
2639|051|S|or pharmacist for more information.||
2639|052|S|   Pain or sores in the mouth and throat may also occur. To||
2639|053|S|reduce the risk of getting mouth sores when you start datopotamab||
2639|054|S|deruxtecan, your doctor may prescribe a mouthwash that contains a||
2639|055|S|steroid medication. Brush your teeth carefully/gently, avoid||
2639|056|S|using mouthwash that contains alcohol, and rinse your mouth often||
2639|057|S|with cool water mixed with baking soda or salt. It may also be||
2639|058|S|best to eat soft, moist foods.||
2639|059|S|   People using this medication may have serious side effects.||
2639|060|S|However, you have been prescribed this drug because your doctor||
2639|061|S|has judged that the benefit to you is greater than the risk of||
2639|062|S|side effects. Careful monitoring by your doctor may decrease your||
2639|063|S|risk.||
2639|064|S|   Tell your doctor right away if you have any serious side||
2639|065|S|effects, including: eye pain/redness/swelling/irritation, eye||
2639|066|S|discharge, vision changes (such as blurred vision, sensitivity to||
2639|067|S|light).||
2639|068|S|   Although this medication is used to treat certain types of||
2639|069|S|lung cancers, it may rarely cause other serious (possibly fatal)||
2639|070|S|lung problems. Tell your doctor right away if you have any new or||
2639|071|S|worsening shortness of breath, cough, fever, or chest tightness.||
2639|072|S|   A very serious allergic reaction to this drug is rare.||
2639|073|S|However, get medical help right away if you notice any symptoms||
2639|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2639|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2639|076|S|breathing.||
2639|077|S|   This is not a complete list of possible side effects. If you||
2639|078|S|notice other effects not listed above, contact your doctor or||
2639|079|S|pharmacist.||
2639|080|S|   In the US -||
2639|081|S|   Call your doctor for medical advice about side effects. You||
2639|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2639|083|S|www.fda.gov/medwatch.||
2639|084|S|   In Canada - Call your doctor for medical advice about side||
2639|085|S|effects. You may report side effects to Health Canada at||
2639|086|S|1-866-234-2345.||
2639|087|B|||
2639|088|P|PRECAUTIONS:  Before using datopotamab deruxtecan, tell your||
2639|089|P|doctor or pharmacist if you are allergic to it; or if you have||
2639|090|P|any other allergies. This product may contain inactive||
2639|091|P|ingredients, which can cause allergic reactions or other||
2639|092|P|problems. Talk to your pharmacist for more details.||
2639|093|P|   Before using this medication, tell your doctor or pharmacist||
2639|094|P|your medical history, especially of: eye problems, kidney||
2639|095|P|disease, liver disease, lung/breathing problems.||
2639|096|P|   Before having surgery, tell your doctor or dentist about all||
2639|097|P|the products you use (including prescription drugs,||
2639|098|P|nonprescription drugs, and herbal products).||
2639|099|P|   Tell your doctor if you are pregnant or plan to become||
2639|100|P|pregnant. You should not become pregnant while using datopotamab||
2639|101|P|deruxtecan. Datopotamab deruxtecan may harm an unborn baby. Your||
2639|102|P|doctor should order a pregnancy test before you start this||
2639|103|P|medication. Women using this medication should ask about reliable||
2639|104|P|forms of birth control during treatment and for 7 months after||
2639|105|P|the last dose. Men using this medication should ask about||
2639|106|P|reliable forms of birth control during treatment and for 4 months||
2639|107|P|after the last dose. If you or your partner becomes pregnant,||
2639|108|P|talk to your doctor right away about the risks and benefits of||
2639|109|P|this medication.||
2639|110|P|   It is unknown if this medication passes into breast milk.||
2639|111|P|Because of the possible risk to the infant, breastfeeding is not||
2639|112|P|recommended while using this medication and for 1 month after the||
2639|113|P|last dose. Consult your doctor before breastfeeding.||
2639|114|B|||
2639|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2639|116|I|medications work or increase your risk for serious side effects.||
2639|117|I|This document does not contain all possible drug interactions.||
2639|118|I|Keep a list of all the products you use (including||
2639|119|I|prescription/nonprescription drugs and herbal products) and share||
2639|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
2639|121|I|the dosage of any medicines without your doctor's approval.||
2639|122|B|||
2639|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2639|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2639|125|O|poison control center right away. US residents can call||
2639|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2639|127|B|||
2639|128|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2639|129|N|liver function, eye exam) may be done before you start using this||
2639|130|N|medication and while you are using it. Keep all medical and lab||
2639|131|N|appointments. Consult your doctor for more details.||
2639|132|B|||
2639|133|D|MISSED DOSE:  It is important to get each dose of this medication||
2639|134|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2639|135|D|right away for a new dosing schedule.||
2639|136|B|||
2639|137|R|STORAGE:  Not applicable. This medication is given in a hospital||
2639|138|R|or clinic and will not be stored at home.||
2639|139|B|||
2639|140|A|Information last revised July 2025.||
2639|141|A|Copyright(c) 2025 First Databank, Inc.||
2639|142|B|||
2640|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2640|002|Z|does NOT have all possible information about this product. This||
2640|003|Z|information does not assure that this product is safe, effective,||
2640|004|Z|or appropriate for you. This information is not individual||
2640|005|Z|medical advice and does not substitute for the advice of your||
2640|006|Z|health care professional. Always ask your health care||
2640|007|Z|professional for complete information about this product and your||
2640|008|Z|specific health needs.||
2640|009|B|||
2640|010|T|AXATILIMAB - INJECTION||
2640|011|B|||
2640|012|C|COMMON BRAND NAME(S): Niktimvo||
2640|013|B|||
2640|014|U|USES:  This medication is used to treat a certain problem that||
2640|015|U|may occur after a stem cell transplant (chronic graft-versus-host||
2640|016|U|disease). Axatilimab belongs to a class of medications known as||
2640|017|U|monoclonal antibodies. It works by blocking some of your immune||
2640|018|U|system's responses which may cause swelling and scarring of||
2640|019|U|certain organs or parts of the body.||
2640|020|B|||
2640|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2640|022|H|from your pharmacist before you start using axatilimab and each||
2640|023|H|time you get a treatment. If you have any questions, ask your||
2640|024|H|doctor or pharmacist.||
2640|025|H|   This medication is given by a health care professional. It is||
2640|026|H|injected slowly into a vein over 30 minutes. It is given as||
2640|027|H|directed by your doctor, usually every 2 weeks. The dosage is||
2640|028|H|based on your medical condition, weight, and response to||
2640|029|H|treatment.||
2640|030|H|   Infusion reactions may happen during the infusion of this||
2640|031|H|drug. Your doctor may prescribe other medications (such as||
2640|032|H|acetaminophen, diphenhydramine) before each treatment to help||
2640|033|H|prevent these side effects. Tell your doctor right away if you||
2640|034|H|have any symptoms of infusion reactions such as fever, chills,||
2640|035|H|flushing, shortness of breath, nausea, vomiting, headaches, or||
2640|036|H|blurred vision. Your doctor may slow down or stop your treatment||
2640|037|H|for some time.||
2640|038|H|   Use this medication regularly to get the most benefit from it.||
2640|039|H|To help you remember, mark your calendar with a reminder.||
2640|040|H|   Tell your doctor if you do not get better or if you get worse.||
2640|041|B|||
2640|042|S|SIDE EFFECTS:  See also How to Use section.||
2640|043|S|   Fatigue, dizziness, cough, diarrhea, or muscle/joint pain may||
2640|044|S|occur. If any of these effects last or get worse, tell your||
2640|045|S|doctor or pharmacist promptly.||
2640|046|S|   Remember that this medication has been prescribed because your||
2640|047|S|doctor has judged that the benefit to you is greater than the||
2640|048|S|risk of side effects. Many people using this medication do not||
2640|049|S|have serious side effects.||
2640|050|S|   Tell your doctor right away if you have any serious side||
2640|051|S|effects, including: signs of infection (such as sore throat that||
2640|052|S|doesn't go away, fever, chills), signs of anemia (such as unusual||
2640|053|S|tiredness, pale skin, fast heartbeat).||
2640|054|S|   A very serious allergic reaction to this drug is rare.||
2640|055|S|However, get medical help right away if you notice any symptoms||
2640|056|S|of a serious allergic reaction, including: rash, itching/swelling||
2640|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2640|058|S|breathing.||
2640|059|S|   This is not a complete list of possible side effects. If you||
2640|060|S|notice other effects not listed above, contact your doctor or||
2640|061|S|pharmacist.||
2640|062|S|   In the US -||
2640|063|S|   Call your doctor for medical advice about side effects. You||
2640|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2640|065|S|www.fda.gov/medwatch.||
2640|066|S|   In Canada - Call your doctor for medical advice about side||
2640|067|S|effects. You may report side effects to Health Canada at||
2640|068|S|1-866-234-2345.||
2640|069|B|||
2640|070|P|PRECAUTIONS:  Before using axatilimab, tell your doctor or||
2640|071|P|pharmacist if you are allergic to it; or if you have any other||
2640|072|P|allergies. This product may contain inactive ingredients, which||
2640|073|P|can cause allergic reactions or other problems. Talk to your||
2640|074|P|pharmacist for more details.||
2640|075|P|   Before using this medication, tell your doctor or pharmacist||
2640|076|P|your medical history, especially of: liver problems.||
2640|077|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
2640|078|P|or marijuana (cannabis) can worsen these effects. Do not drive,||
2640|079|P|use machinery, or do anything that needs alertness or clear||
2640|080|P|vision until you can do it safely. Limit alcoholic beverages.||
2640|081|P|Talk to your doctor if you are using marijuana (cannabis).||
2640|082|P|   Before having surgery, tell your doctor or dentist about all||
2640|083|P|the products you use (including prescription drugs,||
2640|084|P|nonprescription drugs, and herbal products).||
2640|085|P|   Tell your doctor if you are pregnant or plan to become||
2640|086|P|pregnant. You should not become pregnant while using axatilimab.||
2640|087|P|Axatilimab may harm an unborn baby. Your doctor should order a||
2640|088|P|pregnancy test before you start this medication. Ask about||
2640|089|P|reliable forms of birth control while using this medication and||
2640|090|P|for 30 days after the last dose. If you become pregnant, talk to||
2640|091|P|your doctor right away about the risks and benefits of this||
2640|092|P|medication.||
2640|093|P|   It is unknown if this medication passes into breast milk.||
2640|094|P|Because of the possible risk to the infant, breastfeeding is not||
2640|095|P|recommended while using this medication and for 30 days after the||
2640|096|P|last dose. Consult your doctor before breastfeeding.||
2640|097|B|||
2640|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2640|099|I|medications work or increase your risk for serious side effects.||
2640|100|I|This document does not contain all possible drug interactions.||
2640|101|I|Keep a list of all the products you use (including||
2640|102|I|prescription/nonprescription drugs and herbal products) and share||
2640|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
2640|104|I|the dosage of any medicines without your doctor's approval.||
2640|105|B|||
2640|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2640|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2640|108|O|poison control center right away. US residents can call||
2640|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2640|110|B|||
2640|111|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2640|112|N|liver/muscle function, blood mineral levels) should be done||
2640|113|N|before you start using this medication and while you are using||
2640|114|N|it. Keep all medical and lab appointments. Consult your doctor||
2640|115|N|for more details.||
2640|116|B|||
2640|117|D|MISSED DOSE:  It is important to get each dose of this medication||
2640|118|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2640|119|D|right away for a new dosing schedule.||
2640|120|B|||
2640|121|R|STORAGE:  Not applicable. This medication is given in a hospital||
2640|122|R|or clinic and will not be stored at home.||
2640|123|B|||
2640|124|A|Information last revised May 2025.||
2640|125|A|Copyright(c) 2025 First Databank, Inc.||
2640|126|B|||
2641|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2641|002|Z|does NOT have all possible information about this product. This||
2641|003|Z|information does not assure that this product is safe, effective,||
2641|004|Z|or appropriate for you. This information is not individual||
2641|005|Z|medical advice and does not substitute for the advice of your||
2641|006|Z|health care professional. Always ask your health care||
2641|007|Z|professional for complete information about this product and your||
2641|008|Z|specific health needs.||
2641|009|B|||
2641|010|T|SUZETRIGINE - ORAL||
2641|011|B|||
2641|012|C|COMMON BRAND NAME(S): Journavx||
2641|013|B|||
2641|014|U|USES:  This medication is used for short-term relief of moderate||
2641|015|U|to severe pain. Suzetrigine works by changing how your body feels||
2641|016|U|and responds to pain.||
2641|017|B|||
2641|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2641|019|H|from your pharmacist before you start taking suzetrigine and each||
2641|020|H|time you get a refill. If you have any questions, ask your doctor||
2641|021|H|or pharmacist.||
2641|022|H|   Take this medication by mouth as directed by your doctor,||
2641|023|H|usually every 12 hours. Swallow the tablets whole. Do not crush||
2641|024|H|or chew the tablets. To help the medication start working faster,||
2641|025|H|take the first dose on an empty stomach at least 1 hour before or||
2641|026|H|2 hours after food. You may drink clear liquids (such as water,||
2641|027|H|apple juice, vegetable broth, tea, black coffee) during this||
2641|028|H|time. Later doses may be taken with or without food.||
2641|029|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2641|030|H|using this medication unless your doctor or pharmacist says you||
2641|031|H|may do so safely. Grapefruit can increase the chance of side||
2641|032|H|effects with this medicine. Ask your doctor or pharmacist for||
2641|033|H|more details.||
2641|034|H|   The dosage is based on your medical condition, response to||
2641|035|H|treatment, and other medications you may be taking. Be sure to||
2641|036|H|tell your doctor and pharmacist about all the products you use||
2641|037|H|(including prescription drugs, nonprescription drugs, and herbal||
2641|038|H|products).||
2641|039|H|   Take this medication for the shortest time needed. Tell your||
2641|040|H|doctor if your pain lasts more than 14 days or gets worse. Do not||
2641|041|H|use this medication for longer than prescribed.||
2641|042|B|||
2641|043|S|SIDE EFFECTS:  Muscle spasms may occur. If this effect lasts or||
2641|044|S|gets worse, tell your doctor or pharmacist promptly.||
2641|045|S|   Remember that this medication has been prescribed because your||
2641|046|S|doctor has judged that the benefit to you is greater than the||
2641|047|S|risk of side effects. Many people using this medication do not||
2641|048|S|have serious side effects.||
2641|049|S|   A very serious allergic reaction to this drug is rare.||
2641|050|S|However, get medical help right away if you notice any symptoms||
2641|051|S|of a serious allergic reaction, including: rash, itching/swelling||
2641|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2641|053|S|breathing.||
2641|054|S|   This is not a complete list of possible side effects. If you||
2641|055|S|notice other effects not listed above, contact your doctor or||
2641|056|S|pharmacist.||
2641|057|S|   In the US -||
2641|058|S|   Call your doctor for medical advice about side effects. You||
2641|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2641|060|S|www.fda.gov/medwatch.||
2641|061|S|   In Canada - Call your doctor for medical advice about side||
2641|062|S|effects. You may report side effects to Health Canada at||
2641|063|S|1-866-234-2345.||
2641|064|B|||
2641|065|P|PRECAUTIONS:  Before taking suzetrigine, tell your doctor or||
2641|066|P|pharmacist if you are allergic to it; or if you have any other||
2641|067|P|allergies. This product may contain inactive ingredients, which||
2641|068|P|can cause allergic reactions or other problems. Talk to your||
2641|069|P|pharmacist for more details.||
2641|070|P|   Before using this medication, tell your doctor or pharmacist||
2641|071|P|your medical history, especially of: kidney disease, liver||
2641|072|P|disease.||
2641|073|P|   Before having surgery, tell your doctor or dentist about all||
2641|074|P|the products you use (including prescription drugs,||
2641|075|P|nonprescription drugs, and herbal products).||
2641|076|P|   During pregnancy, this medication should be used only when||
2641|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
2641|078|P|   It is unknown if this medication passes into breast milk.||
2641|079|P|Consult your doctor before breastfeeding.||
2641|080|B|||
2641|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2641|082|I|medications work or increase your risk for serious side effects.||
2641|083|I|This document does not contain all possible drug interactions.||
2641|084|I|Keep a list of all the products you use (including||
2641|085|I|prescription/nonprescription drugs and herbal products) and share||
2641|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
2641|087|I|the dosage of any medicines without your doctor's approval.||
2641|088|I|   Other medications can affect the removal of suzetrigine from||
2641|089|I|your body, which may affect how suzetrigine works. Examples||
2641|090|I|include adagrasib, azole antifungals (such as itraconazole,||
2641|091|I|ketoconazole, voriconazole), clarithromycin, cobicistat, certain||
2641|092|I|HIV protease inhibitors (such as tipranavir), idelalisib,||
2641|093|I|lonafarnib, mifepristone, nefazodone, ribociclib, among others.||
2641|094|I|   This medication may decrease the effectiveness of hormonal||
2641|095|I|birth control such as pills, patch, or ring. This could cause||
2641|096|I|pregnancy. Discuss with your doctor or pharmacist if you should||
2641|097|I|use reliable backup birth control methods while using this||
2641|098|I|medication and for 28 days after the last dose. Also tell your||
2641|099|I|doctor if you have any new spotting or breakthrough bleeding,||
2641|100|I|because these may be signs that your birth control is not working||
2641|101|I|well.||
2641|102|B|||
2641|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2641|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2641|105|O|poison control center right away. US residents can call||
2641|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2641|107|B|||
2641|108|N|NOTES:  Do not share this medication with others.||
2641|109|N|   Keep all medical and lab appointments.||
2641|110|B|||
2641|111|D|MISSED DOSE:  It is important to get each dose of this medication||
2641|112|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2641|113|D|right away for a new dosing schedule.||
2641|114|B|||
2641|115|R|STORAGE:  Store at room temperature away from light and moisture.||
2641|116|R|Do not store in the bathroom. Keep all medications away from||
2641|117|R|children and pets.||
2641|118|R|   Do not flush medications down the toilet or pour them into a||
2641|119|R|drain unless instructed to do so. Properly discard this product||
2641|120|R|when it is expired or no longer needed. Consult your pharmacist||
2641|121|R|or local waste disposal company.||
2641|122|B|||
2641|123|A|Information last revised February 2025.||
2641|124|A|Copyright(c) 2025 First Databank, Inc.||
2641|125|B|||
2642|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2642|002|Z|does NOT have all possible information about this product. This||
2642|003|Z|information does not assure that this product is safe, effective,||
2642|004|Z|or appropriate for you. This information is not individual||
2642|005|Z|medical advice and does not substitute for the advice of your||
2642|006|Z|health care professional. Always ask your health care||
2642|007|Z|professional for complete information about this product and your||
2642|008|Z|specific health needs.||
2642|009|B|||
2642|010|T|RISDIPLAM - ORAL||
2642|011|F|(ris-DIP-lam)||
2642|012|B|||
2642|013|C|COMMON BRAND NAME(S): Evrysdi||
2642|014|B|||
2642|015|U|USES:  This medication is used to treat a certain muscle disorder||
2642|016|U|(spinal muscular atrophy - SMA).||
2642|017|B|||
2642|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2642|019|H|from your pharmacist before you start taking risdiplam and each||
2642|020|H|time you get a refill. If you have any questions, ask your doctor||
2642|021|H|or pharmacist.||
2642|022|H|   Take this medication by mouth with or without food as directed||
2642|023|H|by your doctor, usually once daily. Swallow the tablet whole with||
2642|024|H|some water. Do not chew, cut, or crush the tablet. The dosage is||
2642|025|H|based on your age and body weight.||
2642|026|H|   If you have trouble swallowing the tablet whole, you may place||
2642|027|H|the tablet in a small cup and mix it in one teaspoonful (5||
2642|028|H|milliliters) of non-chlorinated water (such as filtered water).||
2642|029|H|Do not use any other liquids. Protect the mixture from sunlight.||
2642|030|H|Swirl the cup gently for about 3 minutes until the tablet and||
2642|031|H|water are mixed (some particles may remain) and take the mixture||
2642|032|H|right away. Rinse the cup with at least an additional one||
2642|033|H|tablespoon (15 milliliters) of filtered water, then swirl and||
2642|034|H|drink the remaining mixture to make sure you get the full dose.||
2642|035|H|Once mixed, the mixture must be taken right away. If the dose is||
2642|036|H|not taken within 10 minutes, throw away the mixture and prepare a||
2642|037|H|new dose. Do not give the mixture through a feeding tube.||
2642|038|H|   Use this medication regularly to get the most benefit from it.||
2642|039|H|To help you remember, take it at the same time each day.||
2642|040|H|   If you vomit after taking a dose or did not take the full||
2642|041|H|dose, do not take another dose at that time. Take your next dose||
2642|042|H|at the regular time.||
2642|043|H|   Tell your doctor if your condition does not get better or if||
2642|044|H|it gets worse.||
2642|045|B|||
2642|046|S|SIDE EFFECTS:  Diarrhea, constipation, mouth sores, or joint pain||
2642|047|S|may occur. If any of these effects last or get worse, tell your||
2642|048|S|doctor or pharmacist promptly.||
2642|049|S|   Remember that this medication has been prescribed because your||
2642|050|S|doctor has judged that the benefit to you is greater than the||
2642|051|S|risk of side effects. Many people using this medication do not||
2642|052|S|have serious side effects.||
2642|053|S|   Tell your doctor right away if you have any serious side||
2642|054|S|effects, including: signs of infection (such as sore throat that||
2642|055|S|doesn't go away, fever, chills).||
2642|056|S|   Risdiplam can commonly cause a rash that is usually not||
2642|057|S|serious. However, you may not be able to tell it apart from a||
2642|058|S|rare rash that could be a sign of a severe reaction. Get medical||
2642|059|S|help right away if you develop any rash.||
2642|060|S|   A very serious allergic reaction to this drug is rare.||
2642|061|S|However, get medical help right away if you notice any symptoms||
2642|062|S|of a serious allergic reaction, including: rash, itching/swelling||
2642|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2642|064|S|breathing.||
2642|065|S|   This is not a complete list of possible side effects. If you||
2642|066|S|notice other effects not listed above, contact your doctor or||
2642|067|S|pharmacist.||
2642|068|S|   In the US -||
2642|069|S|   Call your doctor for medical advice about side effects. You||
2642|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2642|071|S|www.fda.gov/medwatch.||
2642|072|S|   In Canada - Call your doctor for medical advice about side||
2642|073|S|effects. You may report side effects to Health Canada at||
2642|074|S|1-866-234-2345.||
2642|075|B|||
2642|076|P|PRECAUTIONS:  Before taking risdiplam, tell your doctor or||
2642|077|P|pharmacist if you are allergic to it; or if you have any other||
2642|078|P|allergies. This product may contain inactive ingredients, which||
2642|079|P|can cause allergic reactions or other problems. Talk to your||
2642|080|P|pharmacist for more details.||
2642|081|P|   Before using this medication, tell your doctor or pharmacist||
2642|082|P|your medical history, especially of: liver disease.||
2642|083|P|   Before having surgery, tell your doctor or dentist about all||
2642|084|P|the products you use (including prescription drugs,||
2642|085|P|nonprescription drugs, and herbal products).||
2642|086|P|   Tell your doctor if you are pregnant or plan to become||
2642|087|P|pregnant. You should not become pregnant while using risdiplam.||
2642|088|P|Risdiplam may harm an unborn baby. Your doctor should order a||
2642|089|P|pregnancy test before you start this medication. Ask about||
2642|090|P|reliable forms of birth control while using this medication and||
2642|091|P|for some time after the last dose. If you become pregnant, talk||
2642|092|P|to your doctor right away about the risks and benefits of this||
2642|093|P|medication.||
2642|094|P|   It is unknown if this medication passes into breast milk.||
2642|095|P|Consult your doctor before breastfeeding.||
2642|096|B|||
2642|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2642|098|I|medications work or increase your risk for serious side effects.||
2642|099|I|This document does not contain all possible drug interactions.||
2642|100|I|Keep a list of all the products you use (including||
2642|101|I|prescription/nonprescription drugs and herbal products) and share||
2642|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
2642|103|I|the dosage of any medicines without your doctor's approval.||
2642|104|I|   This medication can slow down the removal of other medications||
2642|105|I|from your body, which may affect how they work. An example of an||
2642|106|I|affected drug is dofetilide, among others.||
2642|107|B|||
2642|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2642|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2642|110|O|poison control center right away. US residents can call||
2642|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2642|112|B|||
2642|113|N|NOTES:  Do not share this medication with others.||
2642|114|B|||
2642|115|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2642|116|D|remember. If it is more than 6 hours after the missed dose, skip||
2642|117|D|the missed dose. Take your next dose at the regular time. Do not||
2642|118|D|double the dose to catch up.||
2642|119|B|||
2642|120|R|STORAGE:  Store at room temperature away from light and moisture.||
2642|121|R|Do not store in the bathroom. Keep all medications away from||
2642|122|R|children and pets.||
2642|123|R|   Do not flush medications down the toilet or pour them into a||
2642|124|R|drain unless instructed to do so. Properly discard this product||
2642|125|R|when it is expired or no longer needed. Consult your pharmacist||
2642|126|R|or local waste disposal company.||
2642|127|B|||
2642|128|A|Information last revised September 2025.||
2642|129|A|Copyright(c) 2025 First Databank, Inc.||
2642|130|B|||
2643|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2643|002|Z|does NOT have all possible information about this product. This||
2643|003|Z|information does not assure that this product is safe, effective,||
2643|004|Z|or appropriate for you. This information is not individual||
2643|005|Z|medical advice and does not substitute for the advice of your||
2643|006|Z|health care professional. Always ask your health care||
2643|007|Z|professional for complete information about this product and your||
2643|008|Z|specific health needs.||
2643|009|B|||
2643|010|T|MIRDAMETINIB - ORAL||
2643|011|F|(MIR-da-ME-ti-nib)||
2643|012|B|||
2643|013|C|COMMON BRAND NAME(S): Gomekli||
2643|014|B|||
2643|015|U|USES:  Mirdametinib is used to treat a type of tumor that grows||
2643|016|U|on nerves (neurofibromatosis type 1). Mirdametinib belongs to a||
2643|017|U|class of drugs known as kinase inhibitors. It works by slowing or||
2643|018|U|stopping the growth of tumor cells.||
2643|019|B|||
2643|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2643|021|H|from your pharmacist before you start taking mirdametinib and||
2643|022|H|each time you get a refill. If you have any questions, ask your||
2643|023|H|doctor or pharmacist.||
2643|024|H|   Take this medication by mouth with or without food as directed||
2643|025|H|by your doctor, usually twice daily (about 12 hours apart) on||
2643|026|H|days 1 through 21 of each 28-day treatment cycle. Swallow the||
2643|027|H|capsules whole. Do not open, break, or chew the capsules. The||
2643|028|H|dosage is based on your medical condition, body size, and||
2643|029|H|response to treatment.||
2643|030|H|   If you vomit after taking a dose, do not take another dose at||
2643|031|H|that time. Take your next dose at the regular time.||
2643|032|H|   Use this medication regularly to get the most benefit from it.||
2643|033|H|To help you remember, take it at the same times each day.||
2643|034|H|   Do not increase your dose or use this drug more often or for||
2643|035|H|longer than prescribed. Your condition will not improve any||
2643|036|H|faster, and your risk of side effects will increase.||
2643|037|H|   Since this drug can be absorbed through the skin and lungs and||
2643|038|H|may harm an unborn baby, women who are pregnant or who may become||
2643|039|H|pregnant should not handle this medication or breathe the dust||
2643|040|H|from the capsules.||
2643|041|B|||
2643|042|S|SIDE EFFECTS:  Dry/itchy skin, skin bumps, diarrhea, nausea,||
2643|043|S|vomiting, abdominal pain, muscle/joint/bone pain, tiredness, or||
2643|044|S|headache may occur. If any of these effects last or get worse,||
2643|045|S|tell your doctor or pharmacist promptly.||
2643|046|S|   Remember that this medication has been prescribed because your||
2643|047|S|doctor has judged that the benefit to you is greater than the||
2643|048|S|risk of side effects. Many people using this medication do not||
2643|049|S|have serious side effects.||
2643|050|S|   Tell your doctor right away if you have any serious side||
2643|051|S|effects, including: hair loss, signs of heart problems (shortness||
2643|052|S|of breath, swelling ankles/feet, unusual tiredness,||
2643|053|S|unusual/sudden weight gain), vision changes (such as blurred||
2643|054|S|vision, loss of vision).||
2643|055|S|   Mirdametinib can commonly cause a rash that is usually not||
2643|056|S|serious. However, you may not be able to tell it apart from a||
2643|057|S|rare rash that could be a sign of a severe reaction. Tell your||
2643|058|S|doctor right away if you develop any rash.||
2643|059|S|   A very serious allergic reaction to this drug is rare.||
2643|060|S|However, get medical help right away if you notice any symptoms||
2643|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2643|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2643|063|S|breathing.||
2643|064|S|   This is not a complete list of possible side effects. If you||
2643|065|S|notice other effects not listed above, contact your doctor or||
2643|066|S|pharmacist.||
2643|067|S|   In the US -||
2643|068|S|   Call your doctor for medical advice about side effects. You||
2643|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2643|070|S|www.fda.gov/medwatch.||
2643|071|S|   In Canada - Call your doctor for medical advice about side||
2643|072|S|effects. You may report side effects to Health Canada at||
2643|073|S|1-866-234-2345.||
2643|074|B|||
2643|075|P|PRECAUTIONS:  Before taking mirdametinib, tell your doctor or||
2643|076|P|pharmacist if you are allergic to it; or if you have any other||
2643|077|P|allergies. This product may contain inactive ingredients, which||
2643|078|P|can cause allergic reactions or other problems. Talk to your||
2643|079|P|pharmacist for more details.||
2643|080|P|   Before using this medication, tell your doctor or pharmacist||
2643|081|P|your medical history, especially of: heart problems, eye||
2643|082|P|problems.||
2643|083|P|   This drug may cause blurred vision. Do not drive, use||
2643|084|P|machinery, or do anything that needs clear vision until you can||
2643|085|P|do it safely. Limit alcoholic beverages. Talk to your doctor if||
2643|086|P|you are using marijuana (cannabis).||
2643|087|P|   Before having surgery, tell your doctor or dentist about all||
2643|088|P|the products you use (including prescription drugs,||
2643|089|P|nonprescription drugs, and herbal products).||
2643|090|P|   Since this drug can be absorbed through the skin and lungs and||
2643|091|P|may harm an unborn baby, women who are pregnant or who may become||
2643|092|P|pregnant should not handle this medication or breathe the dust||
2643|093|P|from the capsules.||
2643|094|P|   Tell your doctor if you are pregnant or plan to become||
2643|095|P|pregnant. You should not become pregnant while using||
2643|096|P|mirdametinib. Mirdametinib may harm an unborn baby. Your doctor||
2643|097|P|should order a pregnancy test before you start this medication.||
2643|098|P|Women using this medication should ask about reliable forms of||
2643|099|P|birth control during treatment and for 6 weeks after the last||
2643|100|P|dose. Men using this medication should ask about reliable forms||
2643|101|P|of birth control during treatment and for 3 months after the last||
2643|102|P|dose. If you or your partner becomes pregnant, talk to your||
2643|103|P|doctor right away about the risks and benefits of this||
2643|104|P|medication.||
2643|105|P|   It is unknown if this medication passes into breast milk.||
2643|106|P|Because of the possible risk to the infant, breastfeeding is not||
2643|107|P|recommended while using this medication and for 1 week after the||
2643|108|P|last dose. Consult your doctor before breastfeeding.||
2643|109|B|||
2643|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2643|111|I|medications work or increase your risk for serious side effects.||
2643|112|I|This document does not contain all possible drug interactions.||
2643|113|I|Keep a list of all the products you use (including||
2643|114|I|prescription/nonprescription drugs and herbal products) and share||
2643|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
2643|116|I|the dosage of any medicines without your doctor's approval.||
2643|117|B|||
2643|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2643|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2643|120|O|poison control center right away. US residents can call||
2643|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2643|122|B|||
2643|123|N|NOTES:  Do not share this medication with others.||
2643|124|N|   Lab and/or medical tests (such as heart function, eye exams,||
2643|125|N|CPK levels) should be done before you start taking this||
2643|126|N|medication and while you are taking it. Keep all medical and lab||
2643|127|N|appointments. Consult your doctor for more details.||
2643|128|B|||
2643|129|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2643|130|D|next dose at the regular time. Do not double the dose to catch||
2643|131|D|up.||
2643|132|B|||
2643|133|R|STORAGE:  Store at room temperature away from light and moisture.||
2643|134|R|Do not store in the bathroom. Keep all medications away from||
2643|135|R|children and pets.||
2643|136|R|   Do not flush medications down the toilet or pour them into a||
2643|137|R|drain unless instructed to do so. Properly discard this product||
2643|138|R|when it is expired or no longer needed. Consult your pharmacist||
2643|139|R|or local waste disposal company.||
2643|140|B|||
2643|141|A|Information last revised February 2025.||
2643|142|A|Copyright(c) 2025 First Databank, Inc.||
2643|143|B|||
2644|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2644|002|Z|does NOT have all possible information about this product. This||
2644|003|Z|information does not assure that this product is safe, effective,||
2644|004|Z|or appropriate for you. This information is not individual||
2644|005|Z|medical advice and does not substitute for the advice of your||
2644|006|Z|health care professional. Always ask your health care||
2644|007|Z|professional for complete information about this product and your||
2644|008|Z|specific health needs.||
2644|009|B|||
2644|010|T|MIRDAMETINIB TABLET - FOR ORAL SUSPENSION||
2644|011|F|(MIR-da-ME-ti-nib)||
2644|012|B|||
2644|013|C|COMMON BRAND NAME(S): Gomekli||
2644|014|B|||
2644|015|U|USES:  Mirdametinib is used to treat a type of tumor that grows||
2644|016|U|on nerves (neurofibromatosis type 1). Mirdametinib belongs to a||
2644|017|U|class of drugs known as kinase inhibitors. It works by slowing or||
2644|018|U|stopping the growth of tumor cells.||
2644|019|B|||
2644|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
2644|021|H|Instructions for Use if available from your pharmacist before you||
2644|022|H|start taking mirdametinib and each time you get a refill. If you||
2644|023|H|have any questions, ask your doctor or pharmacist.||
2644|024|H|   Take this medication by mouth with or without food as directed||
2644|025|H|by your doctor, usually twice daily (about 12 hours apart) on||
2644|026|H|days 1 through 21 of each 28-day treatment cycle. The tablets may||
2644|027|H|be swallowed whole or mixed in water before taking. The dosage is||
2644|028|H|based on your medical condition, body size, and response to||
2644|029|H|treatment.||
2644|030|H|   If you are mixing the tablets in water, add the prescribed||
2644|031|H|number of tablet(s) to a cup with 1 to 2 teaspoons (5 to 10||
2644|032|H|milliliters) of water. Swirl the cup to gently mix the tablets in||
2644|033|H|water until no lumps remain (about 2 to 4 minutes). Only use||
2644|034|H|water to prepare the dose. The mixture will look white and||
2644|035|H|cloudy. Drink the mixture right away. To make sure you have taken||
2644|036|H|all of the medication, add another 1 to 2 teaspoons (5 to 10||
2644|037|H|milliliters) of water to the cup, swirl, then drink the rinse||
2644|038|H|water. Throw away any unused mixture after 30 minutes.||
2644|039|H|   If you vomit after taking a dose, do not take another dose at||
2644|040|H|that time. Take your next dose at the regular time.||
2644|041|H|   Use this medication regularly to get the most benefit from it.||
2644|042|H|To help you remember, take it at the same times each day.||
2644|043|H|   Do not increase your dose or use this drug more often or for||
2644|044|H|longer than prescribed. Your condition will not improve any||
2644|045|H|faster, and your risk of side effects will increase.||
2644|046|H|   Since this drug can be absorbed through the skin and lungs and||
2644|047|H|may harm an unborn baby, women who are pregnant or who may become||
2644|048|H|pregnant should not handle this medication or breathe the dust||
2644|049|H|from the tablets.||
2644|050|B|||
2644|051|S|SIDE EFFECTS:  Dry/itchy skin, skin bumps, diarrhea, nausea,||
2644|052|S|vomiting, abdominal pain, muscle/joint/bone pain, tiredness, or||
2644|053|S|headache may occur. If any of these effects last or get worse,||
2644|054|S|tell your doctor or pharmacist promptly.||
2644|055|S|   Remember that this medication has been prescribed because your||
2644|056|S|doctor has judged that the benefit to you is greater than the||
2644|057|S|risk of side effects. Many people using this medication do not||
2644|058|S|have serious side effects.||
2644|059|S|   Tell your doctor right away if you have any serious side||
2644|060|S|effects, including: hair loss, signs of heart problems (shortness||
2644|061|S|of breath, swelling ankles/feet, unusual tiredness,||
2644|062|S|unusual/sudden weight gain), vision changes (such as blurred||
2644|063|S|vision, loss of vision).||
2644|064|S|   Mirdametinib can commonly cause a rash that is usually not||
2644|065|S|serious. However, you may not be able to tell it apart from a||
2644|066|S|rare rash that could be a sign of a severe reaction. Tell your||
2644|067|S|doctor right away if you develop any rash.||
2644|068|S|   A very serious allergic reaction to this drug is rare.||
2644|069|S|However, get medical help right away if you notice any symptoms||
2644|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2644|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2644|072|S|breathing.||
2644|073|S|   This is not a complete list of possible side effects. If you||
2644|074|S|notice other effects not listed above, contact your doctor or||
2644|075|S|pharmacist.||
2644|076|S|   In the US -||
2644|077|S|   Call your doctor for medical advice about side effects. You||
2644|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2644|079|S|www.fda.gov/medwatch.||
2644|080|S|   In Canada - Call your doctor for medical advice about side||
2644|081|S|effects. You may report side effects to Health Canada at||
2644|082|S|1-866-234-2345.||
2644|083|B|||
2644|084|P|PRECAUTIONS:  Before taking mirdametinib, tell your doctor or||
2644|085|P|pharmacist if you are allergic to it; or if you have any other||
2644|086|P|allergies. This product may contain inactive ingredients, which||
2644|087|P|can cause allergic reactions or other problems. Talk to your||
2644|088|P|pharmacist for more details.||
2644|089|P|   Before using this medication, tell your doctor or pharmacist||
2644|090|P|your medical history, especially of: heart problems, eye||
2644|091|P|problems.||
2644|092|P|   This drug may cause blurred vision. Do not drive, use||
2644|093|P|machinery, or do anything that needs clear vision until you can||
2644|094|P|do it safely. Limit alcoholic beverages. Talk to your doctor if||
2644|095|P|you are using marijuana (cannabis).||
2644|096|P|   Before having surgery, tell your doctor or dentist about all||
2644|097|P|the products you use (including prescription drugs,||
2644|098|P|nonprescription drugs, and herbal products).||
2644|099|P|   Since this drug can be absorbed through the skin and lungs and||
2644|100|P|may harm an unborn baby, women who are pregnant or who may become||
2644|101|P|pregnant should not handle this medication or breathe the dust||
2644|102|P|from the tablets.||
2644|103|P|   Tell your doctor if you are pregnant or plan to become||
2644|104|P|pregnant. You should not become pregnant while using||
2644|105|P|mirdametinib. Mirdametinib may harm an unborn baby. Your doctor||
2644|106|P|should order a pregnancy test before you start this medication.||
2644|107|P|Women using this medication should ask about reliable forms of||
2644|108|P|birth control during treatment and for 6 weeks after the last||
2644|109|P|dose. Men using this medication should ask about reliable forms||
2644|110|P|of birth control during treatment and for 3 months after the last||
2644|111|P|dose. If you or your partner becomes pregnant, talk to your||
2644|112|P|doctor right away about the risks and benefits of this||
2644|113|P|medication.||
2644|114|P|   It is unknown if this medication passes into breast milk.||
2644|115|P|Because of the possible risk to the infant, breastfeeding is not||
2644|116|P|recommended while using this medication and for 1 week after the||
2644|117|P|last dose. Consult your doctor before breastfeeding.||
2644|118|B|||
2644|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2644|120|I|medications work or increase your risk for serious side effects.||
2644|121|I|This document does not contain all possible drug interactions.||
2644|122|I|Keep a list of all the products you use (including||
2644|123|I|prescription/nonprescription drugs and herbal products) and share||
2644|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
2644|125|I|the dosage of any medicines without your doctor's approval.||
2644|126|B|||
2644|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2644|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2644|129|O|poison control center right away. US residents can call||
2644|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2644|131|B|||
2644|132|N|NOTES:  Do not share this medication with others.||
2644|133|N|   Lab and/or medical tests (such as heart function, eye exams,||
2644|134|N|CPK levels) should be done before you start taking this||
2644|135|N|medication and while you are taking it. Keep all medical and lab||
2644|136|N|appointments. Consult your doctor for more details.||
2644|137|B|||
2644|138|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2644|139|D|next dose at the regular time. Do not double the dose to catch||
2644|140|D|up.||
2644|141|B|||
2644|142|R|STORAGE:  Store at room temperature away from light and moisture.||
2644|143|R|Do not store in the bathroom. Keep all medications away from||
2644|144|R|children and pets.||
2644|145|R|   Do not flush medications down the toilet or pour them into a||
2644|146|R|drain unless instructed to do so. Properly discard this product||
2644|147|R|when it is expired or no longer needed. Consult your pharmacist||
2644|148|R|or local waste disposal company.||
2644|149|B|||
2644|150|A|Information last revised February 2025.||
2644|151|A|Copyright(c) 2025 First Databank, Inc.||
2644|152|B|||
2645|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2645|002|Z|does NOT have all possible information about this product. This||
2645|003|Z|information does not assure that this product is safe, effective,||
2645|004|Z|or appropriate for you. This information is not individual||
2645|005|Z|medical advice and does not substitute for the advice of your||
2645|006|Z|health care professional. Always ask your health care||
2645|007|Z|professional for complete information about this product and your||
2645|008|Z|specific health needs.||
2645|009|B|||
2645|010|T|APOMORPHINE - INJECTION||
2645|011|F|(A-poe-MOR-feen)||
2645|012|B|||
2645|013|C|COMMON BRAND NAME(S): Onapgo||
2645|014|B|||
2645|015|U|USES:  This medication is used to decrease the amount of "off"||
2645|016|U|time in people with Parkinson's disease. It can help to decrease||
2645|017|U|symptoms such as shakiness (tremor), stiffness, slowed movement,||
2645|018|U|and unsteadiness. This medication is thought to work by helping||
2645|019|U|to restore the balance of a certain natural substance (dopamine)||
2645|020|U|in the brain.||
2645|021|B|||
2645|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
2645|023|H|Instructions for Use if available from your pharmacist before you||
2645|024|H|start using apomorphine and each time you get a refill. Ask your||
2645|025|H|health care professional how to prepare and use this medication.||
2645|026|H|If you have any questions, ask your doctor or pharmacist.||
2645|027|H|   This medication is usually given as a continuous infusion||
2645|028|H|under the skin using an infusion pump as directed by your doctor.||
2645|029|H|Do not inject this medication into a vein. The infusion is given||
2645|030|H|in the abdomen (except for a 2-inch area around your belly||
2645|031|H|button), thighs, or upper/lower back during waking hours. The||
2645|032|H|dosage is based on your medical condition and response to||
2645|033|H|treatment.||
2645|034|H|   To reduce your risk of side effects, your doctor may direct||
2645|035|H|you to start this medication at a low dose and gradually increase||
2645|036|H|your dose. Nausea is very common with this medication. To||
2645|037|H|decrease nausea, your doctor may direct you to use another||
2645|038|H|medication (such as trimethobenzamide) to prevent or treat||
2645|039|H|nausea. This medication may be started 3 days before you start||
2645|040|H|treatment with apomorphine and should be taken as directed for up||
2645|041|H|to 2 months.||
2645|042|H|   Before using, check this product for particles or||
2645|043|H|discoloration. If either is present, do not use the liquid. Clean||
2645|044|H|the skin you are going to inject into (the injection site) with||
2645|045|H|rubbing alcohol. Change the injection site every day to lessen||
2645|046|H|injury under the skin. Do not inject into skin that is bruised,||
2645|047|H|irritated, or has bumps. Learn how to store and discard medical||
2645|048|H|supplies safely.||
2645|049|H|   Do not stop using this medication without consulting your||
2645|050|H|doctor. Some conditions may become worse when this medication is||
2645|051|H|suddenly stopped. Your dose may need to be gradually decreased.||
2645|052|H|   Rarely, abnormal drug-seeking behavior (drug abuse) is||
2645|053|H|possible with this medication. Do not increase your dose or use||
2645|054|H|it more often than prescribed. Properly stop the medication when||
2645|055|H|so directed.||
2645|056|H|   Tell your doctor if your condition does not get better or if||
2645|057|H|it gets worse.||
2645|058|B|||
2645|059|S|SIDE EFFECTS:  Redness/swelling/pain/itching/bruising at the||
2645|060|S|injection site, nausea, vomiting, headache, dizziness,||
2645|061|S|drowsiness, or trouble sleeping may occur. If any of these||
2645|062|S|effects last or get worse, tell your doctor or pharmacist||
2645|063|S|promptly.||
2645|064|S|   Remember that this medication has been prescribed because your||
2645|065|S|doctor has judged that the benefit to you is greater than the||
2645|066|S|risk of side effects. Many people using this medication do not||
2645|067|S|have serious side effects.||
2645|068|S|   Tell your doctor right away if you have any serious side||
2645|069|S|effects, including: severe pain/swelling/warmth at the injection||
2645|070|S|site, mental/mood changes (such as confusion, agitation,||
2645|071|S|hallucinations), uncontrolled movements, muscle cramps/spasm,||
2645|072|S|unusual strong urges (such as increased gambling, increased||
2645|073|S|sexual urges), unusual tiredness, pale skin.||
2645|074|S|   Get medical help right away if you have any very serious side||
2645|075|S|effects, including: chest pain, shortness of breath,||
2645|076|S|fast/irregular heartbeat, severe dizziness, fainting, trouble||
2645|077|S|speaking, vision changes, weakness on one side of the body.||
2645|078|S|   Some people using apomorphine have fallen asleep suddenly||
2645|079|S|during their usual daily activities (such as talking on the||
2645|080|S|phone, driving). In some cases, sleep occurred without any||
2645|081|S|feelings of drowsiness beforehand. This sleep effect may occur||
2645|082|S|anytime during treatment with apomorphine even if you have used||
2645|083|S|this medication for a long time. If you experience increased||
2645|084|S|sleepiness or fall asleep during the day, do not drive or take||
2645|085|S|part in other possibly dangerous activities until you have||
2645|086|S|discussed this effect with your doctor. Your risk of this sleep||
2645|087|S|effect is increased by using alcohol or other medications that||
2645|088|S|can make you drowsy. See also Precautions section.||
2645|089|S|   You may also develop a sudden drop in blood pressure that can||
2645|090|S|cause dizziness, nausea, and fainting. This effect may also||
2645|091|S|increase your risk of a fall. This drop in blood pressure is more||
2645|092|S|likely when you are first starting the medication, when your dose||
2645|093|S|is increased, or when you get up suddenly. To lower your risk,||
2645|094|S|get up slowly from a sitting or lying position. Avoid alcohol.||
2645|095|S|   Rarely, males may have a painful or prolonged erection lasting||
2645|096|S|4 or more hours. If this occurs, stop using this drug and get||
2645|097|S|medical help right away, or permanent problems could occur.||
2645|098|S|   A very serious allergic reaction to this drug is rare.||
2645|099|S|However, get medical help right away if you notice any symptoms||
2645|100|S|of a serious allergic reaction, including: rash, itching/swelling||
2645|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2645|102|S|breathing.||
2645|103|S|   This is not a complete list of possible side effects. If you||
2645|104|S|notice other effects not listed above, contact your doctor or||
2645|105|S|pharmacist.||
2645|106|S|   In the US -||
2645|107|S|   Call your doctor for medical advice about side effects. You||
2645|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2645|109|S|www.fda.gov/medwatch.||
2645|110|S|   In Canada - Call your doctor for medical advice about side||
2645|111|S|effects. You may report side effects to Health Canada at||
2645|112|S|1-866-234-2345.||
2645|113|B|||
2645|114|P|PRECAUTIONS:  Before using apomorphine, tell your doctor or||
2645|115|P|pharmacist if you are allergic to it; or if you have any other||
2645|116|P|allergies. This product may contain inactive ingredients (such as||
2645|117|P|sulfites), which can cause allergic reactions or other problems.||
2645|118|P|Talk to your pharmacist for more details.||
2645|119|P|   Before using this medication, tell your doctor or pharmacist||
2645|120|P|your medical history, especially of: kidney problems, liver||
2645|121|P|problems, low blood pressure, sleep disorder (such as sleep||
2645|122|P|apnea, narcolepsy), asthma, heart problems (such as chest pain,||
2645|123|P|heart attack), mental/mood disorders (such as hallucinations,||
2645|124|P|psychosis, schizophrenia), stroke.||
2645|125|P|   Apomorphine may cause a condition that affects the heart||
2645|126|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2645|127|P|serious (rarely fatal) fast/irregular heartbeat and other||
2645|128|P|symptoms (such as severe dizziness, fainting) that need medical||
2645|129|P|attention right away.||
2645|130|P|   The risk of QT prolongation may be increased if you have||
2645|131|P|certain medical conditions or are taking other drugs that may||
2645|132|P|cause QT prolongation. Before using apomorphine, tell your doctor||
2645|133|P|or pharmacist of all the drugs you take and if you have any of||
2645|134|P|the following conditions: certain heart problems (heart failure,||
2645|135|P|slow heartbeat, QT prolongation in the EKG), family history of||
2645|136|P|certain heart problems (QT prolongation in the EKG, sudden||
2645|137|P|cardiac death).||
2645|138|P|   Low levels of potassium or magnesium in the blood may also||
2645|139|P|increase your risk of QT prolongation. This risk may increase if||
2645|140|P|you use certain drugs (such as diuretics/"water pills") or if you||
2645|141|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2645|142|P|Talk to your doctor about using apomorphine safely.||
2645|143|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2645|144|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2645|145|P|machinery, or do anything that needs alertness until you can do||
2645|146|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2645|147|P|are using marijuana (cannabis). See also Side Effects section.||
2645|148|P|   Older adults may be more sensitive to the side effects of this||
2645|149|P|drug, especially falls, mental/mood changes (such as confusion,||
2645|150|P|hallucinations), and QT prolongation (see above).||
2645|151|P|   During pregnancy, this medication should be used only when||
2645|152|P|clearly needed. Discuss the risks and benefits with your doctor.||
2645|153|P|   It is unknown if this drug passes into breast milk. Consult||
2645|154|P|your doctor before breastfeeding.||
2645|155|B|||
2645|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2645|157|I|medications work or increase your risk for serious side effects.||
2645|158|I|This document does not contain all possible drug interactions.||
2645|159|I|Keep a list of all the products you use (including||
2645|160|I|prescription/nonprescription drugs and herbal products) and share||
2645|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
2645|162|I|the dosage of any medicines without your doctor's approval.||
2645|163|I|   Some products that may interact with this drug are: alosetron,||
2645|164|I|certain drugs for nausea (including metoclopramide,||
2645|165|I|phenothiazines such as prochlorperazine, serotonin blockers such||
2645|166|I|as ondansetron, granisetron).||
2645|167|I|   Tell your doctor or pharmacist if you are taking other||
2645|168|I|products that cause drowsiness such as opioid pain or cough||
2645|169|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2645|170|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2645|171|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
2645|172|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
2645|173|I|diphenhydramine).||
2645|174|I|   Check the labels on all your medicines (such as allergy or||
2645|175|I|cough-and-cold products) because they may contain ingredients||
2645|176|I|that cause drowsiness. Ask your pharmacist about using those||
2645|177|I|products safely.||
2645|178|B|||
2645|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2645|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2645|181|O|poison control center right away. US residents can call||
2645|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2645|183|B|||
2645|184|N|NOTES:  Do not share this medication with others.||
2645|185|B|||
2645|186|D|MISSED DOSE:  If your dose is interrupted or stopped, contact||
2645|187|D|your doctor right away to establish a new dosing schedule.||
2645|188|B|||
2645|189|R|STORAGE:  Store at room temperature. Keep all medications away||
2645|190|R|from children and pets.||
2645|191|R|   Do not flush medications down the toilet or pour them into a||
2645|192|R|drain unless instructed to do so. Properly discard this product||
2645|193|R|when it is expired or no longer needed. Consult your pharmacist||
2645|194|R|or local waste disposal company.||
2645|195|B|||
2645|196|A|Information last revised March 2025.||
2645|197|A|Copyright(c) 2025 First Databank, Inc.||
2645|198|B|||
2646|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2646|002|Z|does NOT have all possible information about this product. This||
2646|003|Z|information does not assure that this product is safe, effective,||
2646|004|Z|or appropriate for you. This information is not individual||
2646|005|Z|medical advice and does not substitute for the advice of your||
2646|006|Z|health care professional. Always ask your health care||
2646|007|Z|professional for complete information about this product and your||
2646|008|Z|specific health needs.||
2646|009|B|||
2646|010|T|VIMSELTINIB - ORAL||
2646|011|B|||
2646|012|C|COMMON BRAND NAME(S): Romvimza||
2646|013|B|||
2646|014|U|USES:  This medication is used to treat a certain type of tumor||
2646|015|U|(tenosynovial giant cell tumor) that is not likely to improve||
2646|016|U|with surgery. Vimseltinib belongs to a class of drugs known as||
2646|017|U|kinase inhibitors. It works by slowing or stopping the growth of||
2646|018|U|certain tumor cells.||
2646|019|B|||
2646|020|H|HOW TO USE:  Read the Medication Guide provided by your||
2646|021|H|pharmacist before you start taking vimseltinib and each time you||
2646|022|H|get a refill. If you have any questions, ask your doctor or||
2646|023|H|pharmacist.||
2646|024|H|   Take this medication by mouth with or without food as directed||
2646|025|H|by your doctor, usually twice a week, with at least 72 hours (3||
2646|026|H|days) between doses. Swallow the capsules whole. Do not open,||
2646|027|H|break, or chew the capsules. The dosage is based on your medical||
2646|028|H|condition and response to treatment.||
2646|029|H|   If vomiting occurs less than 30 minutes after taking a dose,||
2646|030|H|repeat the dose. If you vomit more than 30 minutes after taking||
2646|031|H|the dose, do not take another dose at that time. Take your next||
2646|032|H|dose at the regular time.||
2646|033|H|   Use this medication regularly to get the most benefit from it.||
2646|034|H|To help you remember, use it on the same days each week. Mark||
2646|035|H|your calendar with a reminder.||
2646|036|H|   Do not increase your dose or use this drug more often or for||
2646|037|H|longer than prescribed. Your condition will not improve any||
2646|038|H|faster, and your risk of serious side effects will increase.||
2646|039|H|   Since this drug can be absorbed through the skin and lungs and||
2646|040|H|may harm an unborn baby, women who are pregnant or who may become||
2646|041|H|pregnant should not handle this medication or breathe the dust||
2646|042|H|from the capsules.||
2646|043|B|||
2646|044|S|SIDE EFFECTS:  Itchy skin or tiredness may occur. If either of||
2646|045|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2646|046|S|promptly.||
2646|047|S|   People using this medication may have serious side effects.||
2646|048|S|However, you have been prescribed this drug because your doctor||
2646|049|S|has judged that the benefit to you is greater than the risk of||
2646|050|S|side effects. Careful monitoring by your doctor may decrease your||
2646|051|S|risk.||
2646|052|S|   Tell your doctor right away if you have any serious side||
2646|053|S|effects, including: signs of liver problems (such as||
2646|054|S|nausea/vomiting that doesn't stop, loss of appetite,||
2646|055|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
2646|056|S|swelling around your eyes/eyelids, swelling of arms/legs/feet,||
2646|057|S|numbness/tingling, signs of infection (such as sore throat that||
2646|058|S|doesn't go away, fever, chills).||
2646|059|S|   Vimseltinib can commonly cause a rash that is usually not||
2646|060|S|serious. However, you may not be able to tell it apart from a||
2646|061|S|rare rash that could be a sign of a severe reaction. Tell your||
2646|062|S|doctor right away if you develop any rash.||
2646|063|S|   A very serious allergic reaction to this drug is rare.||
2646|064|S|However, get medical help right away if you notice any symptoms||
2646|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2646|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2646|067|S|breathing.||
2646|068|S|   This is not a complete list of possible side effects. If you||
2646|069|S|notice other effects not listed above, contact your doctor or||
2646|070|S|pharmacist.||
2646|071|S|   In the US -||
2646|072|S|   Call your doctor for medical advice about side effects. You||
2646|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2646|074|S|www.fda.gov/medwatch.||
2646|075|S|   In Canada - Call your doctor for medical advice about side||
2646|076|S|effects. You may report side effects to Health Canada at||
2646|077|S|1-866-234-2345.||
2646|078|B|||
2646|079|P|PRECAUTIONS:  Before taking vimseltinib, tell your doctor or||
2646|080|P|pharmacist if you are allergic to it; or if you have any other||
2646|081|P|allergies. This product may contain inactive ingredients (such as||
2646|082|P|tartrazine or sunset yellow), which can cause allergic reactions||
2646|083|P|or other problems. Talk to your pharmacist for more details.||
2646|084|P|   Before using this medication, tell your doctor or pharmacist||
2646|085|P|your medical history, especially of: liver problems, kidney||
2646|086|P|problems.||
2646|087|P|   Before having surgery, tell your doctor or dentist about all||
2646|088|P|the products you use (including prescription drugs,||
2646|089|P|nonprescription drugs, and herbal products).||
2646|090|P|   Tell your doctor if you are pregnant or plan to become||
2646|091|P|pregnant. You should not become pregnant while using vimseltinib.||
2646|092|P|Vimseltinib may harm an unborn baby. Your doctor should order a||
2646|093|P|pregnancy test before you start this medication. Men and women||
2646|094|P|using this medication should ask about reliable forms of birth||
2646|095|P|control during treatment and for 1 month after the last dose. If||
2646|096|P|you or your partner becomes pregnant, talk to your doctor right||
2646|097|P|away about the risks and benefits of this medication.||
2646|098|P|   It is unknown if this drug passes into breast milk. Because of||
2646|099|P|the possible risk to the infant, breastfeeding is not recommended||
2646|100|P|while using this drug and for 1 month after the last dose.||
2646|101|P|Consult your doctor before breastfeeding.||
2646|102|B|||
2646|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2646|104|I|medications work or increase your risk for serious side effects.||
2646|105|I|This document does not contain all possible drug interactions.||
2646|106|I|Keep a list of all the products you use (including||
2646|107|I|prescription/nonprescription drugs and herbal products) and share||
2646|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
2646|109|I|the dosage of any medicines without your doctor's approval.||
2646|110|I|   This medication can slow down the removal of other medications||
2646|111|I|from your body, which may affect how they work. An example of an||
2646|112|I|affected drug is dofetilide, among others.||
2646|113|B|||
2646|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2646|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2646|116|O|poison control center right away. US residents can call||
2646|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2646|118|B|||
2646|119|N|NOTES:  Do not share this medication with others.||
2646|120|N|   Lab and/or medical tests (such as complete blood count,||
2646|121|N|liver/kidney function, cholesterol levels) should be done before||
2646|122|N|you start taking this medication and while you are taking it.||
2646|123|N|Keep all medical and lab appointments. Consult your doctor for||
2646|124|N|more details.||
2646|125|B|||
2646|126|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2646|127|D|remember. If it has been more than 48 hours after the missed||
2646|128|D|dose, skip the missed dose. Take your next dose at the regular||
2646|129|D|time. Do not double the dose to catch up.||
2646|130|B|||
2646|131|R|STORAGE:  Store at room temperature away from light and moisture.||
2646|132|R|Keep the medication in the blister pack until ready to use. Do||
2646|133|R|not store in the bathroom. Keep all medications away from||
2646|134|R|children and pets.||
2646|135|R|   Do not flush medications down the toilet or pour them into a||
2646|136|R|drain unless instructed to do so. Properly discard this product||
2646|137|R|when it is expired or no longer needed. Consult your pharmacist||
2646|138|R|or local waste disposal company.||
2646|139|B|||
2646|140|A|Information last revised April 2025.||
2646|141|A|Copyright(c) 2025 First Databank, Inc.||
2646|142|B|||
2647|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2647|002|Z|does NOT have all possible information about this product. This||
2647|003|Z|information does not assure that this product is safe, effective,||
2647|004|Z|or appropriate for you. This information is not individual||
2647|005|Z|medical advice and does not substitute for the advice of your||
2647|006|Z|health care professional. Always ask your health care||
2647|007|Z|professional for complete information about this product and your||
2647|008|Z|specific health needs.||
2647|009|B|||
2647|010|T|BENZGALANTAMINE DELAYED-RELEASE - ORAL||
2647|011|B|||
2647|012|C|COMMON BRAND NAME(S): Zunveyl||
2647|013|B|||
2647|014|U|USES:  Benzgalantamine is used to treat mild to moderate||
2647|015|U|confusion (dementia) related to Alzheimer's disease. It does not||
2647|016|U|cure Alzheimer's disease, but it may improve memory, awareness,||
2647|017|U|and the ability to perform daily functions. This medication works||
2647|018|U|by restoring the balance of certain natural substances||
2647|019|U|(neurotransmitters) in the brain.||
2647|020|B|||
2647|021|H|HOW TO USE:  Take this medication by mouth with or without food||
2647|022|H|as directed by your doctor, usually twice daily. Swallow the||
2647|023|H|tablets whole. Do not split, crush, or chew the tablets. Do not||
2647|024|H|take this medication at the same time as alcohol. Drinking||
2647|025|H|alcohol at the same time you take this medication can release all||
2647|026|H|of the drug at once, increasing the risk of side effects. Drink||
2647|027|H|plenty of fluids with this medication unless instructed||
2647|028|H|otherwise.||
2647|029|H|   The dosage is based on your medical condition and response to||
2647|030|H|treatment. To reduce your risk of side effects, your doctor may||
2647|031|H|direct you to start this medication at a low dose and gradually||
2647|032|H|increase your dose. Follow your doctor's instructions carefully.||
2647|033|H|   If you stop taking benzgalantamine for longer than 3 days,||
2647|034|H|consult your doctor before restarting your medication. Your||
2647|035|H|doctor may direct you to restart this medication at a low dose.||
2647|036|H|   Use this medication regularly to get the most benefit from it.||
2647|037|H|To help you remember, take it at the same times each day.||
2647|038|H|   Do not increase your dose or use this drug more often or for||
2647|039|H|longer than prescribed. Your condition will not improve any||
2647|040|H|faster, and your risk of side effects will increase.||
2647|041|H|   It may take at least 4 weeks of continued use to get the full||
2647|042|H|benefit of this drug.||
2647|043|H|   Tell your doctor if your condition gets worse.||
2647|044|B|||
2647|045|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, dizziness, drowsiness,||
2647|046|S|decreased appetite, or weight loss may occur. If any of these||
2647|047|S|effects last or get worse, tell your doctor or pharmacist||
2647|048|S|promptly.||
2647|049|S|   Remember that this medication has been prescribed because your||
2647|050|S|doctor has judged that the benefit to you is greater than the||
2647|051|S|risk of side effects. Many people using this medication do not||
2647|052|S|have serious side effects.||
2647|053|S|   Tell your doctor right away if you have any serious side||
2647|054|S|effects, including: slow heartbeat, difficulty urinating.||
2647|055|S|   Get medical help right away if you have any very serious side||
2647|056|S|effects, including: seizures, black/bloody stools, vomit that is||
2647|057|S|bloody or looks like coffee grounds, severe stomach/abdominal||
2647|058|S|pain, fast/irregular heartbeat, severe dizziness, fainting.||
2647|059|S|   A very serious allergic reaction to this drug is rare.||
2647|060|S|However, get medical help right away if you notice any symptoms||
2647|061|S|of a serious allergic reaction, including: rash, itching/swelling||
2647|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2647|063|S|breathing.||
2647|064|S|   This is not a complete list of possible side effects. If you||
2647|065|S|notice other effects not listed above, contact your doctor or||
2647|066|S|pharmacist.||
2647|067|S|   In the US -||
2647|068|S|   Call your doctor for medical advice about side effects. You||
2647|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2647|070|S|www.fda.gov/medwatch.||
2647|071|S|   In Canada - Call your doctor for medical advice about side||
2647|072|S|effects. You may report side effects to Health Canada at||
2647|073|S|1-866-234-2345.||
2647|074|B|||
2647|075|P|PRECAUTIONS:  Before taking benzgalantamine, tell your doctor or||
2647|076|P|pharmacist if you are allergic to it; or to galantamine; or if||
2647|077|P|you have any other allergies. This product may contain inactive||
2647|078|P|ingredients, which can cause allergic reactions or other||
2647|079|P|problems. Talk to your pharmacist for more details.||
2647|080|P|   Before using this medication, tell your doctor or pharmacist||
2647|081|P|your medical history, especially of: breathing/lung problems||
2647|082|P|(such as asthma, chronic obstructive pulmonary disease-COPD),||
2647|083|P|heart problems (such as arrhythmias, AV block, sick sinus||
2647|084|P|syndrome), kidney disease, liver disease, seizures,||
2647|085|P|stomach/intestinal problems (such as ulcers, bleeding), problems||
2647|086|P|urinating (such as due to enlarged prostate).||
2647|087|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2647|088|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2647|089|P|machinery, or do anything that needs alertness until you can do||
2647|090|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2647|091|P|are using marijuana (cannabis).||
2647|092|P|   Benzgalantamine may cause a condition that affects the heart||
2647|093|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2647|094|P|serious (rarely fatal) fast/irregular heartbeat and other||
2647|095|P|symptoms (such as severe dizziness, fainting) that need medical||
2647|096|P|attention right away.||
2647|097|P|   The risk of QT prolongation may be increased if you have||
2647|098|P|certain medical conditions or are taking other drugs that may||
2647|099|P|cause QT prolongation. Before using benzgalantamine, tell your||
2647|100|P|doctor or pharmacist of all the drugs you take and if you have||
2647|101|P|any of the following conditions: certain heart problems (heart||
2647|102|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2647|103|P|history of certain heart problems (QT prolongation in the EKG,||
2647|104|P|sudden cardiac death).||
2647|105|P|   Low levels of potassium or magnesium in the blood may also||
2647|106|P|increase your risk of QT prolongation. This risk may increase if||
2647|107|P|you use certain drugs (such as diuretics/"water pills") or if you||
2647|108|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2647|109|P|Talk to your doctor about using benzgalantamine safely.||
2647|110|P|   Before having surgery, tell your doctor or dentist about all||
2647|111|P|the products you use (including prescription drugs,||
2647|112|P|nonprescription drugs, and herbal products).||
2647|113|P|   Older adults may be more sensitive to the side effects of this||
2647|114|P|drug, especially QT prolongation (see above).||
2647|115|P|   During pregnancy, this medication should be used only when||
2647|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
2647|117|P|   It is unknown if this medication passes into breast milk.||
2647|118|P|Consult your doctor before breastfeeding.||
2647|119|B|||
2647|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2647|121|I|medications work or increase your risk for serious side effects.||
2647|122|I|This document does not contain all possible drug interactions.||
2647|123|I|Keep a list of all the products you use (including||
2647|124|I|prescription/nonprescription drugs and herbal products) and share||
2647|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
2647|126|I|the dosage of any medicines without your doctor's approval.||
2647|127|I|   Benzgalantamine is very similar to galantamine. Do not use||
2647|128|I|medications containing galantamine while using benzgalantamine.||
2647|129|B|||
2647|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2647|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2647|132|O|poison control center right away. US residents can call||
2647|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2647|134|O|Symptoms of overdose may include: muscle weakness or twitching,||
2647|135|O|severe stomach cramping, slow or shallow breathing,||
2647|136|O|slow/fast/irregular heartbeat, fainting, and seizures.||
2647|137|B|||
2647|138|N|NOTES:  Do not share this medication with others.||
2647|139|N|   Lab and/or medical tests (such as weight, lung function) may||
2647|140|N|be done while you are taking this medication. Keep all medical||
2647|141|N|and lab appointments. Consult your doctor for more details.||
2647|142|B|||
2647|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2647|144|D|remember. If it is near the time of the next dose, skip the||
2647|145|D|missed dose. Take your next dose at the regular time. Do not||
2647|146|D|double the dose to catch up.||
2647|147|B|||
2647|148|R|STORAGE:  Store at room temperature away from light and moisture.||
2647|149|R|Do not store in the bathroom. Keep all medications away from||
2647|150|R|children and pets.||
2647|151|R|   Do not flush medications down the toilet or pour them into a||
2647|152|R|drain unless instructed to do so. Properly discard this product||
2647|153|R|when it is expired or no longer needed. Consult your pharmacist||
2647|154|R|or local waste disposal company.||
2647|155|B|||
2647|156|A|Information last revised March 2025.||
2647|157|A|Copyright(c) 2025 First Databank, Inc.||
2647|158|B|||
2648|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2648|002|Z|does NOT have all possible information about this product. This||
2648|003|Z|information does not assure that this product is safe, effective,||
2648|004|Z|or appropriate for you. This information is not individual||
2648|005|Z|medical advice and does not substitute for the advice of your||
2648|006|Z|health care professional. Always ask your health care||
2648|007|Z|professional for complete information about this product and your||
2648|008|Z|specific health needs.||
2648|009|B|||
2648|010|T|NILOTINIB TABLET - ORAL||
2648|011|F|(nye-LOE-ti-nib)||
2648|012|B|||
2648|013|C|COMMON BRAND NAME(S): Danziten||
2648|014|B|||
2648|015|W|WARNING:  This drug can rarely cause serious (possibly fatal)||
2648|016|W|irregular heartbeats (QT prolongation). Nilotinib should not be||
2648|017|W|used by people with low blood levels of certain minerals||
2648|018|W|(potassium, magnesium) or a certain heart problem (long QT||
2648|019|W|syndrome). To lower your risk, your doctor will order certain||
2648|020|W|blood tests (potassium/magnesium levels, liver function tests)||
2648|021|W|before and during treatment with nilotinib. You should have a||
2648|022|W|heart test (EKG) before starting nilotinib. The EKG should be||
2648|023|W|repeated 7 days after your first dose, when your dose is changed,||
2648|024|W|and periodically while you are taking nilotinib.||
2648|025|W|   Nilotinib may come in different forms (such as tablet,||
2648|026|W|capsule). Do not switch between different forms without||
2648|027|W|consulting your doctor.||
2648|028|B|||
2648|029|U|USES:  Nilotinib is used to treat a certain type of blood cancer||
2648|030|U|(chronic myelogenous leukemia-CML). It works by slowing or||
2648|031|U|stopping the growth of cancer cells.||
2648|032|B|||
2648|033|H|HOW TO USE:  Read the Medication Guide provided by your||
2648|034|H|pharmacist before you start using nilotinib and each time you get||
2648|035|H|a refill. If you have any questions, consult your doctor or||
2648|036|H|pharmacist.||
2648|037|H|   Take this medication by mouth with or without food as directed||
2648|038|H|by your doctor, usually twice daily (about 12 hours apart).||
2648|039|H|Swallow the tablet whole with water. Do not cut, crush, or chew||
2648|040|H|the tablets.||
2648|041|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2648|042|H|using this medication unless your doctor or pharmacist says you||
2648|043|H|may do so safely. Grapefruit can increase the chance of side||
2648|044|H|effects with this medicine. Ask your doctor or pharmacist for||
2648|045|H|more details.||
2648|046|H|   Drink plenty of fluids during treatment with this medication,||
2648|047|H|unless otherwise directed by your doctor.||
2648|048|H|   Medications that reduce stomach acid (such as antacids, proton||
2648|049|H|pump inhibitors/PPIs, H2 blockers) may make nilotinib work less||
2648|050|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
2648|051|H|using this medication. If you take antacids, take them 2 hours||
2648|052|H|before or 2 hours after nilotinib. If you take H2 blockers (such||
2648|053|H|as famotidine, nizatidine), take them 10 hours before or 2 hours||
2648|054|H|after nilotinib.||
2648|055|H|   The dosage is based on your medical condition, response to||
2648|056|H|treatment, lab tests, and other medications you may be taking. Be||
2648|057|H|sure to tell your doctor and pharmacist about all the products||
2648|058|H|you use (including prescription drugs, nonprescription drugs, and||
2648|059|H|herbal products). Children's dosage is also based on body size.||
2648|060|H|   Do not increase your dose or take this medication more often||
2648|061|H|than prescribed. Your condition will not improve any faster, and||
2648|062|H|the risk of serious side effects will increase.||
2648|063|H|   Since this drug can be absorbed through the skin and lungs and||
2648|064|H|may harm an unborn baby, women who are pregnant or who may become||
2648|065|H|pregnant should not handle this medication or breathe the dust||
2648|066|H|from the tablets.||
2648|067|B|||
2648|068|S|SIDE EFFECTS:  See also Warning section.||
2648|069|S|   Nausea, vomiting, headache, tiredness, constipation, or||
2648|070|S|diarrhea may occur. If any of these effects last or get worse,||
2648|071|S|tell your doctor or pharmacist promptly.||
2648|072|S|   People using this medication may have serious side effects.||
2648|073|S|However, you have been prescribed this drug because your doctor||
2648|074|S|has judged that the benefit to you is greater than the risk of||
2648|075|S|side effects. Careful monitoring by your doctor may decrease your||
2648|076|S|risk.||
2648|077|S|   This medication decreases bone marrow function, an effect that||
2648|078|S|may lead to a low number of blood cells such as red cells, white||
2648|079|S|cells, and platelets. This effect can cause anemia, decrease your||
2648|080|S|body's ability to fight an infection, or cause easy||
2648|081|S|bruising/bleeding. Tell your doctor right away if you develop any||
2648|082|S|of the following serious symptoms: unusual tiredness, pale skin,||
2648|083|S|signs of infection (such as sore throat that doesn't go away,||
2648|084|S|fever, chills), easy bruising/bleeding (such as bloody/black||
2648|085|S|stool).||
2648|086|S|   Nilotinib sometimes causes side effects due to the rapid||
2648|087|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
2648|088|S|risk, your doctor may add a medication and tell you to drink||
2648|089|S|plenty of fluids. Tell your doctor right away if you have||
2648|090|S|symptoms such as: low back/side pain (flank pain), signs of||
2648|091|S|kidney problems (such as painful urination, pink/bloody urine,||
2648|092|S|change in the amount of urine), muscle spasms/weakness.||
2648|093|S|   Tell your doctor right away if you have any serious side||
2648|094|S|effects, including: severe stomach/abdominal pain, toe/joint||
2648|095|S|pain, swelling hands/ankles/feet, unusual/rapid weight gain,||
2648|096|S|symptoms of high blood sugar (such as increased||
2648|097|S|thirst/urination), signs of liver disease (such as||
2648|098|S|nausea/vomiting that doesn't stop, loss of appetite,||
2648|099|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2648|100|S|   Get medical help right away if you have any very serious side||
2648|101|S|effects, including: fast/pounding/irregular heartbeat, severe||
2648|102|S|dizziness, fainting, seizures, signs of a heart attack (such as||
2648|103|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
2648|104|S|signs of a stroke (such as weakness on one side of the body,||
2648|105|S|trouble speaking, sudden vision changes, confusion), signs of||
2648|106|S|bleeding in the brain (such as sudden severe headache, sudden||
2648|107|S|vision changes, confusion, loss of consciousness), signs of blood||
2648|108|S|circulation disease (such as numbness/pain in the legs, leg pain||
2648|109|S|with physical activity, decrease in walking distance).||
2648|110|S|   A very serious allergic reaction to this drug is rare.||
2648|111|S|However, get medical help right away if you notice any symptoms||
2648|112|S|of a serious allergic reaction, including: rash, itching/swelling||
2648|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2648|114|S|breathing.||
2648|115|S|   This is not a complete list of possible side effects. If you||
2648|116|S|notice other effects not listed above, contact your doctor or||
2648|117|S|pharmacist.||
2648|118|S|   In the US -||
2648|119|S|   Call your doctor for medical advice about side effects. You||
2648|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2648|121|S|www.fda.gov/medwatch.||
2648|122|S|   In Canada - Call your doctor for medical advice about side||
2648|123|S|effects. You may report side effects to Health Canada at||
2648|124|S|1-866-234-2345.||
2648|125|B|||
2648|126|P|PRECAUTIONS:  Before taking nilotinib, tell your doctor or||
2648|127|P|pharmacist if you are allergic to it; or if you have any other||
2648|128|P|allergies. This product may contain inactive ingredients, which||
2648|129|P|can cause allergic reactions or other problems. Talk to your||
2648|130|P|pharmacist for more details.||
2648|131|P|   Before using this medication, tell your doctor or pharmacist||
2648|132|P|your medical history, especially of: liver disease, pancreatitis,||
2648|133|P|heart disease (such as coronary artery disease, chest pain, heart||
2648|134|P|attack), high blood pressure, high cholesterol, diabetes, stroke||
2648|135|P|(including "mini-strokes" or transient ischemic attacks), blood||
2648|136|P|circulation disease (peripheral arterial disease), blood vessel||
2648|137|P|disease (hardening of the arteries/atherosclerosis), stomach||
2648|138|P|surgery (such as gastrectomy), lactose/galactose intolerance.||
2648|139|P|   Nilotinib may cause a condition that affects the heart rhythm||
2648|140|P|(QT prolongation). QT prolongation can rarely cause serious||
2648|141|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2648|142|P|as severe dizziness, fainting) that need medical attention right||
2648|143|P|away.||
2648|144|P|   The risk of QT prolongation may be increased if you have||
2648|145|P|certain medical conditions or are taking other drugs that may||
2648|146|P|cause QT prolongation. Before using nilotinib, tell your doctor||
2648|147|P|or pharmacist of all the drugs you take and if you have any of||
2648|148|P|the following conditions: certain heart problems (heart failure,||
2648|149|P|slow heartbeat, QT prolongation in the EKG), family history of||
2648|150|P|certain heart problems (QT prolongation in the EKG, sudden||
2648|151|P|cardiac death).||
2648|152|P|   Low levels of potassium or magnesium in the blood may also||
2648|153|P|increase your risk of QT prolongation. This risk may increase if||
2648|154|P|you use certain drugs (such as diuretics/"water pills") or if you||
2648|155|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2648|156|P|Talk to your doctor about using nilotinib safely.||
2648|157|P|   Before having surgery, tell your doctor or dentist about all||
2648|158|P|the products you use (including prescription drugs,||
2648|159|P|nonprescription drugs, and herbal products).||
2648|160|P|   Nilotinib can make you more likely to get infections or may||
2648|161|P|make current infections worse. Stay away from anyone who has an||
2648|162|P|infection that may easily spread (such as chickenpox, COVID-19,||
2648|163|P|measles, flu). Talk to your doctor if you have been exposed to an||
2648|164|P|infection or for more details.||
2648|165|P|   Tell your health care professional that you are using||
2648|166|P|nilotinib before having any immunizations/vaccinations. Avoid||
2648|167|P|contact with people who have recently received live vaccines||
2648|168|P|(such as flu vaccine inhaled through the nose).||
2648|169|P|   To lower the chance of getting cut, bruised, or injured, use||
2648|170|P|caution with sharp objects like razors and nail cutters, and||
2648|171|P|avoid activities such as contact sports.||
2648|172|P|   Children may be more sensitive to the side effects of this||
2648|173|P|drug, especially liver disease and slowed growth and development.||
2648|174|P|Consult the doctor or pharmacist for more details. See the doctor||
2648|175|P|regularly so your child's liver function, height, weight, and||
2648|176|P|development can be checked.||
2648|177|P|   Older adults may be more sensitive to the side effects of this||
2648|178|P|drug, especially QT prolongation (see above).||
2648|179|P|   Since this drug can be absorbed through the skin and lungs and||
2648|180|P|may harm an unborn baby, women who are pregnant or who may become||
2648|181|P|pregnant should not handle this medication or breathe the dust||
2648|182|P|from the tablets.||
2648|183|P|   Tell your doctor if you are pregnant or plan to become||
2648|184|P|pregnant. You should not become pregnant while using nilotinib.||
2648|185|P|Nilotinib may harm an unborn baby. Your doctor should order a||
2648|186|P|pregnancy test before you start this medication. Ask about||
2648|187|P|reliable forms of birth control while using this medication and||
2648|188|P|for 14 days after the last dose. If you become pregnant, talk to||
2648|189|P|your doctor right away about the risks and benefits of this||
2648|190|P|medication.||
2648|191|P|   It is unknown if this drug passes into breast milk. Because of||
2648|192|P|the possible risk to the infant, breastfeeding is not recommended||
2648|193|P|while using this drug and for 14 days after the last dose.||
2648|194|P|Consult your doctor before breastfeeding.||
2648|195|B|||
2648|196|I|DRUG INTERACTIONS:  See also How to Use section.||
2648|197|I|   Drug interactions may change how your medications work or||
2648|198|I|increase your risk for serious side effects. This document does||
2648|199|I|not contain all possible drug interactions. Keep a list of all||
2648|200|I|the products you use (including prescription/nonprescription||
2648|201|I|drugs and herbal products) and share it with your doctor and||
2648|202|I|pharmacist. Do not start, stop, or change the dosage of any||
2648|203|I|medicines without your doctor's approval.||
2648|204|I|   Some products that may interact with this drug are:||
2648|205|I|elacestrant, flibanserin.||
2648|206|I|   Other medications can affect the removal of nilotinib from||
2648|207|I|your body, which may affect how nilotinib works. Examples include||
2648|208|I|azole antifungals (such as itraconazole, ketoconazole), macrolide||
2648|209|I|antibiotics (such as clarithromycin), rifamycins (such as||
2648|210|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
2648|211|I|seizures (such as carbamazepine, phenytoin), among others.||
2648|212|I|   Many drugs besides nilotinib may affect the heart rhythm (QT||
2648|213|I|prolongation), such as amiodarone, dofetilide, pimozide,||
2648|214|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
2648|215|I|erythromycin), among others.||
2648|216|B|||
2648|217|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2648|218|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2648|219|O|poison control center right away. US residents can call||
2648|220|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2648|221|B|||
2648|222|N|NOTES:  Do not share this medication with others.||
2648|223|N|   Lab and/or medical tests (such as growth and development||
2648|224|N|checks for children, complete blood count, EKG, blood mineral||
2648|225|N|levels, liver function, lipase levels, uric acid level,||
2648|226|N|cholesterol level, blood sugar) should be done while you are||
2648|227|N|taking this medication. Keep all medical and lab appointments.||
2648|228|N|Consult your doctor for more details.||
2648|229|B|||
2648|230|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2648|231|D|next dose at the regular time. Do not double the dose to catch||
2648|232|D|up.||
2648|233|B|||
2648|234|R|STORAGE:  Store at room temperature away from light and moisture.||
2648|235|R|Do not store in the bathroom. Keep all medications away from||
2648|236|R|children and pets.||
2648|237|R|   Do not flush medications down the toilet or pour them into a||
2648|238|R|drain unless instructed to do so. Properly discard this product||
2648|239|R|when it is expired or no longer needed. Consult your pharmacist||
2648|240|R|or local waste disposal company.||
2648|241|B|||
2648|242|M|MEDICAL ALERT:  Your condition can cause complications in a||
2648|243|M|medical emergency. For information about enrolling in MedicAlert,||
2648|244|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2648|245|B|||
2648|246|A|Information last revised September 2025.||
2648|247|A|Copyright(c) 2025 First Databank, Inc.||
2648|248|B|||
2649|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2649|002|Z|does NOT have all possible information about this product. This||
2649|003|Z|information does not assure that this product is safe, effective,||
2649|004|Z|or appropriate for you. This information is not individual||
2649|005|Z|medical advice and does not substitute for the advice of your||
2649|006|Z|health care professional. Always ask your health care||
2649|007|Z|professional for complete information about this product and your||
2649|008|Z|specific health needs.||
2649|009|B|||
2649|010|T|REMESTEMCEL - INJECTION||
2649|011|F|(REM-e-STEM-sel)||
2649|012|B|||
2649|013|C|COMMON BRAND NAME(S): Ryoncil||
2649|014|B|||
2649|015|U|USES:  This medication is used to treat a certain problem that||
2649|016|U|may happen after a stem cell transplant (acute graft-versus-host||
2649|017|U|disease) that has not gotten better or that has come back after||
2649|018|U|other kinds of treatment. This problem causes immune system||
2649|019|U|responses which lead to swelling and damage to parts of your||
2649|020|U|body. Remestemcel is made from special cells (mesenchymal stromal||
2649|021|U|cells) which help reduce those immune system responses.||
2649|022|B|||
2649|023|H|HOW TO USE:  This medication is given by injection into a vein by||
2649|024|H|a health care professional. It is given as directed by your||
2649|025|H|doctor, usually twice weekly, at least 3 days apart.||
2649|026|H|   The dosage is based on your weight and response to treatment.||
2649|027|H|   Infusion reactions may happen during the infusion of this||
2649|028|H|drug. Your doctor may prescribe other medications (such as||
2649|029|H|steroids, antihistamines) before each treatment to help prevent||
2649|030|H|these side effects. Tell your doctor right away if you have any||
2649|031|H|symptoms of infusion reactions such as fever, shortness of||
2649|032|H|breath, or low blood pressure. Your doctor may slow down or stop||
2649|033|H|your treatment for some time.||
2649|034|B|||
2649|035|S|SIDE EFFECTS:  See also How to Use section.||
2649|036|S|   Diarrhea, vomiting, or stomach pain may occur. If any of these||
2649|037|S|effects last or get worse, tell your doctor or pharmacist||
2649|038|S|promptly.||
2649|039|S|   Remember that this medication has been prescribed because your||
2649|040|S|doctor has judged that the benefit to you is greater than the||
2649|041|S|risk of side effects. Many people using this medication do not||
2649|042|S|have serious side effects.||
2649|043|S|   Tell your doctor right away if you have any serious side||
2649|044|S|effects, including: signs of infection (such as sore throat that||
2649|045|S|doesn't go away, fever, chills), swelling of arms/legs/feet,||
2649|046|S|unusual growths/lumps.||
2649|047|S|   A very serious allergic reaction to this drug is rare.||
2649|048|S|However, get medical help right away if you notice any symptoms||
2649|049|S|of a serious allergic reaction, including: rash, itching/swelling||
2649|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2649|051|S|breathing.||
2649|052|S|   This is not a complete list of possible side effects. If you||
2649|053|S|notice other effects not listed above, contact your doctor or||
2649|054|S|pharmacist.||
2649|055|S|   In the US -||
2649|056|S|   Call your doctor for medical advice about side effects. You||
2649|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2649|058|S|www.fda.gov/medwatch.||
2649|059|S|   In Canada - Call your doctor for medical advice about side||
2649|060|S|effects. You may report side effects to Health Canada at||
2649|061|S|1-866-234-2345.||
2649|062|B|||
2649|063|P|PRECAUTIONS:  Before using remestemcel, tell your doctor or||
2649|064|P|pharmacist if you are allergic to it; or dimethyl sulfoxide||
2649|065|P|(DMSO); or beef or pork products; or if you have any other||
2649|066|P|allergies. This product may contain inactive ingredients, which||
2649|067|P|can cause allergic reactions or other problems. Talk to your||
2649|068|P|pharmacist for more details.||
2649|069|P|   Before using this medication, tell your doctor or pharmacist||
2649|070|P|your medical history, especially of: past/current/recent||
2649|071|P|infection.||
2649|072|P|   Before having surgery, tell your doctor or dentist about all||
2649|073|P|the products you use (including prescription drugs,||
2649|074|P|nonprescription drugs, and herbal products).||
2649|075|P|   Tell your doctor if you are pregnant or plan to become||
2649|076|P|pregnant. You should not become pregnant while using remestemcel.||
2649|077|P|Remestemcel may harm an unborn baby. If you become pregnant, talk||
2649|078|P|to your doctor right away about the risks and benefits of this||
2649|079|P|medication.||
2649|080|P|   It is unknown if this product passes into breast milk. Consult||
2649|081|P|your doctor before breastfeeding.||
2649|082|B|||
2649|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2649|084|I|medications work or increase your risk for serious side effects.||
2649|085|I|This document does not contain all possible drug interactions.||
2649|086|I|Keep a list of all the products you use (including||
2649|087|I|prescription/nonprescription drugs and herbal products) and share||
2649|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
2649|089|I|the dosage of any medicines without your doctor's approval.||
2649|090|B|||
2649|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2649|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2649|093|O|poison control center right away. US residents can call||
2649|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2649|095|B|||
2649|096|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
2649|097|N|may be done while you are receiving this product. Keep all||
2649|098|N|medical and lab appointments.||
2649|099|B|||
2649|100|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
2649|101|D|right away for a new dosing schedule.||
2649|102|B|||
2649|103|R|STORAGE:  Not applicable. This product is given in a hospital or||
2649|104|R|clinic and will not be stored at home.||
2649|105|B|||
2649|106|A|Information last revised May 2025.||
2649|107|A|Copyright(c) 2025 First Databank, Inc.||
2649|108|B|||
2650|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2650|002|Z|does NOT have all possible information about this product. This||
2650|003|Z|information does not assure that this product is safe, effective,||
2650|004|Z|or appropriate for you. This information is not individual||
2650|005|Z|medical advice and does not substitute for the advice of your||
2650|006|Z|health care professional. Always ask your health care||
2650|007|Z|professional for complete information about this product and your||
2650|008|Z|specific health needs.||
2650|009|B|||
2650|010|T|RIZATRIPTAN/MELOXICAM - ORAL||
2650|011|F|(RYE-za-TRIP-tan/mel-OX-i-kam)||
2650|012|B|||
2650|013|C|COMMON BRAND NAME(S): Symbravo||
2650|014|B|||
2650|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
2650|016|W|meloxicam) may rarely increase the risk for a heart attack or||
2650|017|W|stroke. This effect can happen at any time while taking this drug||
2650|018|W|but is more likely if you take it for a long time. The risk may||
2650|019|W|be greater in older adults or if you have heart disease or||
2650|020|W|increased risk for heart disease (for example, due to smoking,||
2650|021|W|family history of heart disease, or conditions such as high blood||
2650|022|W|pressure or diabetes). Do not take this drug right before or||
2650|023|W|after heart bypass surgery (CABG).||
2650|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
2650|025|W|bleeding from the stomach or intestines. This effect can occur||
2650|026|W|without warning symptoms at any time while taking this drug.||
2650|027|W|Older adults may be at higher risk for this effect.||
2650|028|W|   Stop taking this medication and get medical help right away if||
2650|029|W|you notice any of these rare but serious side effects:||
2650|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
2650|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
2650|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
2650|033|W|side of the body, trouble speaking, sudden vision changes.||
2650|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
2650|035|W|of taking this drug.||
2650|036|B|||
2650|037|U|USES:  This combination medication contains two ingredients:||
2650|038|U|rizatriptan and meloxicam. It helps to relieve headache, pain,||
2650|039|U|and other migraine symptoms (such as nausea, vomiting,||
2650|040|U|sensitivity to light/sound). Prompt treatment helps you return to||
2650|041|U|your normal routine and may decrease your need for other pain||
2650|042|U|medications.||
2650|043|U|   Rizatriptan belongs to a class of drugs known as triptans. It||
2650|044|U|affects a certain natural substance (serotonin) that causes||
2650|045|U|narrowing of blood vessels in the brain. It may also relieve pain||
2650|046|U|by affecting certain nerves in the brain. Meloxicam is known as a||
2650|047|U|nonsteroidal anti-inflammatory drug (NSAID). It is used to||
2650|048|U|relieve pain.||
2650|049|U|   This medication does not prevent future migraines or lessen||
2650|050|U|how often you get migraine attacks.||
2650|051|B|||
2650|052|H|HOW TO USE:  Read the Medication Guide provided by your||
2650|053|H|pharmacist before you start taking this medication and each time||
2650|054|H|you get a refill. If you have any questions, ask your doctor or||
2650|055|H|pharmacist.||
2650|056|H|   Take this medication by mouth at the first sign of a migraine||
2650|057|H|as directed by your doctor. Swallow the tablets whole. Do not||
2650|058|H|crush, divide, or chew the tablets. Take this medication with a||
2650|059|H|full glass of water (8 ounces or 240 milliliters) unless your||
2650|060|H|doctor directs you otherwise. Do not lie down for at least 10||
2650|061|H|minutes after taking this medication. If stomach upset occurs||
2650|062|H|while taking this medication, take it with food, milk, or an||
2650|063|H|antacid.||
2650|064|H|   If your symptoms don't get better, do not take more doses of||
2650|065|H|this medication before talking to your doctor. According to the||
2650|066|H|manufacturer, you should not take more than 1 dose in a 24-hour||
2650|067|H|period.||
2650|068|H|   If you have a higher risk for heart problems (see Precautions||
2650|069|H|section), your doctor may perform a heart exam before you start||
2650|070|H|taking this medication. Your doctor may also direct you to take||
2650|071|H|your first dose of this medication in the office/clinic to||
2650|072|H|monitor for serious side effects (such as chest pain). Talk to||
2650|073|H|your doctor for more details.||
2650|074|H|   If you are using drugs for migraine attacks on 10 or more days||
2650|075|H|each month, the drugs may actually make your headaches worse||
2650|076|H|(medication overuse headache). Do not use medications more often||
2650|077|H|or for longer than directed. Tell your doctor if you need to use||
2650|078|H|this medication more often, or if the medication is not working||
2650|079|H|as well, or if your headaches get worse.||
2650|080|B|||
2650|081|S|SIDE EFFECTS:  See also Warning section.||
2650|082|S|   Flushing, feelings of tingling/numbness/prickling/heat,||
2650|083|S|tiredness, weakness, drowsiness, or dizziness may occur. If any||
2650|084|S|of these effects last or get worse, tell your doctor or||
2650|085|S|pharmacist promptly.||
2650|086|S|   Remember that this medication has been prescribed because your||
2650|087|S|doctor has judged that the benefit to you is greater than the||
2650|088|S|risk of side effects. Many people using this medication do not||
2650|089|S|have serious side effects.||
2650|090|S|   This medication may raise your blood pressure. Check your||
2650|091|S|blood pressure regularly and tell your doctor if the results are||
2650|092|S|high.||
2650|093|S|   Tell your doctor right away if you have any serious side||
2650|094|S|effects, including: blue fingers/toes/nails, cold hands/feet,||
2650|095|S|hearing changes (such as ringing in the ears), mental/mood||
2650|096|S|changes, easy bruising/bleeding, difficult/painful swallowing,||
2650|097|S|signs of kidney problems (such as change in the amount of urine),||
2650|098|S|symptoms of heart failure (such as swelling ankles/feet, unusual||
2650|099|S|tiredness, unusual/sudden weight gain).||
2650|100|S|   This medication can commonly cause chest/jaw/neck tightness,||
2650|101|S|pain, or pressure that is usually not serious. However, these||
2650|102|S|side effects are like symptoms of a heart attack, which may||
2650|103|S|include chest/jaw/left arm pain, shortness of breath, or unusual||
2650|104|S|sweating. Get medical help right away if these or other serious||
2650|105|S|side effects occur, including: fast/irregular heartbeat,||
2650|106|S|fainting, severe stomach/abdominal pain, bloody diarrhea,||
2650|107|S|seizure, signs of a stroke (such as weakness on one side of the||
2650|108|S|body, trouble speaking, sudden vision changes, confusion).||
2650|109|S|   This medication may rarely cause serious (possibly fatal)||
2650|110|S|liver disease. Get medical help right away if you have any||
2650|111|S|symptoms of liver damage, including: nausea/vomiting that doesn't||
2650|112|S|stop, loss of appetite, yellowing eyes/skin, dark urine.||
2650|113|S|   This medication may increase serotonin and rarely cause a very||
2650|114|S|serious condition called serotonin syndrome/toxicity. The risk||
2650|115|S|increases if you are also taking other drugs that increase||
2650|116|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2650|117|S|take (see Drug Interactions section). Get medical help right away||
2650|118|S|if you develop some of the following symptoms: fast heartbeat,||
2650|119|S|hallucinations, loss of coordination, severe dizziness, severe||
2650|120|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2650|121|S|unusual agitation/restlessness.||
2650|122|S|   A very serious allergic reaction to this drug is rare.||
2650|123|S|However, get medical help right away if you notice any symptoms||
2650|124|S|of a serious allergic reaction, including: fever, swollen lymph||
2650|125|S|nodes, rash, itching/swelling (especially of the||
2650|126|S|face/tongue/throat), severe dizziness, trouble breathing.||
2650|127|S|   This is not a complete list of possible side effects. If you||
2650|128|S|notice other effects not listed above, contact your doctor or||
2650|129|S|pharmacist.||
2650|130|S|   In the US -||
2650|131|S|   Call your doctor for medical advice about side effects. You||
2650|132|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2650|133|S|www.fda.gov/medwatch.||
2650|134|S|   In Canada - Call your doctor for medical advice about side||
2650|135|S|effects. You may report side effects to Health Canada at||
2650|136|S|1-866-234-2345.||
2650|137|B|||
2650|138|P|PRECAUTIONS:  See also Warning section.||
2650|139|P|   Before taking this medication, tell your doctor or pharmacist||
2650|140|P|if you are allergic to rizatriptan or meloxicam; or to aspirin or||
2650|141|P|other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you||
2650|142|P|have any other allergies. This product may contain inactive||
2650|143|P|ingredients, which can cause allergic reactions or other||
2650|144|P|problems. Talk to your pharmacist for more details.||
2650|145|P|   Before taking this medication, tell your doctor or pharmacist||
2650|146|P|your medical history, especially of: asthma (including a history||
2650|147|P|of worsening breathing after taking aspirin or other NSAIDs),||
2650|148|P|blood circulation problems (for example, in your legs,||
2650|149|P|arms/hands, or stomach), blood disorders (such as anemia),||
2650|150|P|bleeding/clotting problems, growths in the nose (nasal polyps),||
2650|151|P|heart problems (such as chest pain, irregular heartbeat, previous||
2650|152|P|heart attack), certain types of headaches (hemiplegic or basilar||
2650|153|P|migraine), liver disease, seizure, stomach/intestinal/esophagus||
2650|154|P|problems (such as bleeding, heartburn, ulcers), stroke or||
2650|155|P|"mini-stroke" (transient ischemic attack), swelling (edema, fluid||
2650|156|P|retention).||
2650|157|P|   Certain conditions can increase your risk for heart problems.||
2650|158|P|Tell your doctor if you have any of these conditions, including:||
2650|159|P|high blood pressure, high cholesterol, diabetes, family history||
2650|160|P|of heart disease, overweight, smoker, postmenopausal (women), age||
2650|161|P|more than 40 years (men).||
2650|162|P|   Kidney problems can sometimes occur with the use of NSAID||
2650|163|P|medications, including meloxicam. Problems are more likely to||
2650|164|P|occur if you are dehydrated, have heart failure or kidney||
2650|165|P|disease, are an older adult, or if you take certain medications||
2650|166|P|(see also Drug Interactions section). Drink plenty of fluids as||
2650|167|P|directed by your doctor to prevent dehydration and tell your||
2650|168|P|doctor right away if you have any unusual change in the amount of||
2650|169|P|urine.||
2650|170|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2650|171|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2650|172|P|machinery, or do anything that needs alertness until you can do||
2650|173|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2650|174|P|are using marijuana (cannabis).||
2650|175|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
2650|176|P|and tobacco, especially when combined with this medicine, may||
2650|177|P|increase your risk for stomach bleeding. Limit alcohol and stop||
2650|178|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
2650|179|P|may safely drink.||
2650|180|P|   This medication may make you more sensitive to the sun. Limit||
2650|181|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2650|182|P|sunscreen and wear protective clothing when outdoors. Tell your||
2650|183|P|doctor right away if you get sunburned or have skin||
2650|184|P|blisters/redness.||
2650|185|P|   Before having surgery, tell your doctor or dentist about all||
2650|186|P|the products you use (including prescription drugs,||
2650|187|P|nonprescription drugs, and herbal products).||
2650|188|P|   Older adults may be at greater risk for stomach/intestinal||
2650|189|P|bleeding, kidney problems, heart attack, and stroke while taking||
2650|190|P|this drug.||
2650|191|P|   Before taking this medication, women of childbearing age||
2650|192|P|should talk with their doctor(s) about the benefits and risks.||
2650|193|P|Tell your doctor if you are pregnant or if you plan to become||
2650|194|P|pregnant. This medication may harm an unborn baby and cause||
2650|195|P|problems with normal labor/delivery. It is not recommended for||
2650|196|P|use in pregnancy from 20 weeks until delivery. If your doctor||
2650|197|P|decides that you need to use this medication between 20 and 30||
2650|198|P|weeks of pregnancy, you should use the lowest effective dose for||
2650|199|P|the shortest possible time. You should not use this medication||
2650|200|P|after 30 weeks of pregnancy.||
2650|201|P|   Rizatriptan passes into breast milk. It is unknown if||
2650|202|P|meloxicam passes into breast milk. Consult your doctor before||
2650|203|P|breastfeeding.||
2650|204|B|||
2650|205|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2650|206|I|medications work or increase your risk for serious side effects.||
2650|207|I|This document does not contain all possible drug interactions.||
2650|208|I|Keep a list of all the products you use (including||
2650|209|I|prescription/nonprescription drugs and herbal products) and share||
2650|210|I|it with your doctor and pharmacist. Do not start, stop, or change||
2650|211|I|the dosage of any medicines without your doctor's approval.||
2650|212|I|   Some products that may interact with this drug are: aliskiren,||
2650|213|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
2650|214|I|receptor blockers (such as losartan, valsartan), cidofovir,||
2650|215|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
2650|216|I|methotrexate, "water pills" (diuretics such as furosemide).||
2650|217|I|   Taking MAO inhibitors with this medication may cause a serious||
2650|218|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
2650|219|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2650|220|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2650|221|I|selegiline, tranylcypromine) during treatment with this||
2650|222|I|medication. Most MAO inhibitors should also not be taken for two||
2650|223|I|weeks before treatment with this medication. Ask your doctor when||
2650|224|I|to start or stop taking this medication.||
2650|225|I|   The risk of serotonin syndrome/toxicity increases if you are||
2650|226|I|also taking other drugs that increase serotonin. Examples include||
2650|227|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
2650|228|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2650|229|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2650|230|I|serotonin syndrome/toxicity may be more likely when you start or||
2650|231|I|increase the dose of these drugs.||
2650|232|I|   This medication may increase the risk of bleeding when taken||
2650|233|I|with other drugs that also may cause bleeding. Examples include||
2650|234|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2650|235|I|dabigatran/enoxaparin/warfarin, among others.||
2650|236|I|   Check all prescription and nonprescription medicine labels||
2650|237|I|carefully since many medications contain pain relievers/fever||
2650|238|I|reducers (including aspirin, NSAIDs such as celecoxib, ibuprofen,||
2650|239|I|or ketorolac). These drugs are similar to meloxicam and may||
2650|240|I|increase your risk of side effects if taken together. However, if||
2650|241|I|your doctor has told you to take low-dose aspirin to prevent||
2650|242|I|heart attack or stroke (usually 81-162 milligrams a day), you||
2650|243|I|should keep taking the aspirin unless your doctor tells you not||
2650|244|I|to. Daily use of meloxicam may decrease aspirin's ability to||
2650|245|I|prevent heart attack/stroke. Talk with your doctor about the||
2650|246|I|risks and benefits. Ask about other medications that can be used||
2650|247|I|to treat pain/fever.||
2650|248|I|   If you also take any ergotamine medication (such as||
2650|249|I|dihydroergotamine) or other "triptan" drugs (such as sumatriptan,||
2650|250|I|zolmitriptan), you will need to separate your rizatriptan dose at||
2650|251|I|least 24 hours apart from your dose of these other medications to||
2650|252|I|lessen the chance of serious side effects.||
2650|253|B|||
2650|254|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2650|255|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2650|256|O|poison control center right away. US residents can call||
2650|257|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2650|258|O|Symptoms of overdose may include: slow/shallow breathing, extreme||
2650|259|O|drowsiness, severe stomach pain, vomit that looks like coffee||
2650|260|O|grounds.||
2650|261|B|||
2650|262|N|NOTES:  Do not share this medication with others.||
2650|263|N|   Certain foods, beverages, or food additives (such as red wine,||
2650|264|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
2650|265|N|patterns such as irregular eating/sleeping habits or stress may||
2650|266|N|bring on a migraine headache. Avoiding these "triggers" may help||
2650|267|N|lessen migraine attacks. Consult your doctor for more details.||
2650|268|N|   Lab and/or medical tests (such as complete blood count,||
2650|269|N|liver/kidney function, blood pressure) may be done while you are||
2650|270|N|taking this medication. Keep all medical and lab appointments.||
2650|271|N|Consult your doctor for more details.||
2650|272|B|||
2650|273|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
2650|274|B|||
2650|275|R|STORAGE:  Store in the original bottle at room temperature away||
2650|276|R|from light and moisture. Do not store in the bathroom. Keep all||
2650|277|R|medications away from children and pets.||
2650|278|R|   Do not flush medications down the toilet or pour them into a||
2650|279|R|drain unless instructed to do so. Properly discard this product||
2650|280|R|when it is expired or no longer needed. Consult your pharmacist||
2650|281|R|or local waste disposal company.||
2650|282|B|||
2650|283|A|Information last revised November 2025.||
2650|284|A|Copyright(c) 2025 First Databank, Inc.||
2650|285|B|||
2651|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2651|002|Z|does NOT have all possible information about this product. This||
2651|003|Z|information does not assure that this product is safe, effective,||
2651|004|Z|or appropriate for you. This information is not individual||
2651|005|Z|medical advice and does not substitute for the advice of your||
2651|006|Z|health care professional. Always ask your health care||
2651|007|Z|professional for complete information about this product and your||
2651|008|Z|specific health needs.||
2651|009|B|||
2651|010|T|TRAMETINIB SOLUTION - ORAL||
2651|011|F|(tra-ME-ti-nib)||
2651|012|B|||
2651|013|C|COMMON BRAND NAME(S): Mekinist||
2651|014|B|||
2651|015|U|USES:  Trametinib is used to treat various cancers (such as skin,||
2651|016|U|thyroid, lung, solid tumors, brain). It belongs to a class of||
2651|017|U|drugs known as kinase inhibitors. Trametinib works by slowing or||
2651|018|U|stopping the growth of cancer cells.||
2651|019|B|||
2651|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
2651|021|H|Instructions for Use if available from your pharmacist before you||
2651|022|H|start taking trametinib and each time you get a refill. If you||
2651|023|H|have any questions, ask your doctor or pharmacist.||
2651|024|H|   Take this medication by mouth as directed by your doctor,||
2651|025|H|usually once daily. Take this medication on an empty stomach (at||
2651|026|H|least 1 hour before or 2 hours after a meal) or with a low-fat||
2651|027|H|meal. The dosage is based on your medical condition and response||
2651|028|H|to treatment. Children's dosage is also based on weight.||
2651|029|H|   Gently swirl the bottle for 30 seconds to mix the solution||
2651|030|H|before each dose. Learn how to carefully measure the dose using||
2651|031|H|the bottle adapter and oral syringe provided. Do not use a||
2651|032|H|household spoon because you may not get the correct dose. If you||
2651|033|H|have any questions, consult your doctor or pharmacist.||
2651|034|H|   This medication may also be given through a tube into the||
2651|035|H|stomach (nasogastric or gastric tube). If you are giving this||
2651|036|H|medication through a nasogastric or gastric tube, ask your health||
2651|037|H|care professional for detailed instructions on how to give it.||
2651|038|H|   If you vomit, do not take another dose to catch up. Take your||
2651|039|H|next dose at the regular time.||
2651|040|H|   Take this medication regularly to get the most benefit from||
2651|041|H|it. To help you remember, take it at the same time each day.||
2651|042|H|   Do not increase your dose or use this drug more often or for||
2651|043|H|longer than prescribed. Your condition will not improve any||
2651|044|H|faster, and your risk of side effects will increase.||
2651|045|B|||
2651|046|S|SIDE EFFECTS:  Dizziness, diarrhea, nausea/vomiting, stomach||
2651|047|S|pain, dry/itchy skin, acne, or dry mouth may occur. Weight gain||
2651|048|S|may also occur in children. If any of these effects last or get||
2651|049|S|worse, tell your doctor or pharmacist promptly. To relieve dry||
2651|050|S|mouth, suck (sugarless) hard candy or ice chips, chew (sugarless)||
2651|051|S|gum, drink water, or use a saliva substitute.||
2651|052|S|   Pain or sores in the mouth and throat may occur. Brush your||
2651|053|S|teeth carefully/gently, avoid using mouthwash that contains||
2651|054|S|alcohol, and rinse your mouth often with cool water mixed with||
2651|055|S|baking soda or salt. It may also be best to eat soft, moist||
2651|056|S|foods.||
2651|057|S|   People using this medication may have serious side effects.||
2651|058|S|However, you have been prescribed this drug because your doctor||
2651|059|S|has judged that the benefit to you is greater than the risk of||
2651|060|S|side effects. Careful monitoring by your doctor may decrease your||
2651|061|S|risk.||
2651|062|S|   This medication may raise your blood pressure. Check your||
2651|063|S|blood pressure regularly and tell your doctor if the results are||
2651|064|S|high.||
2651|065|S|   Tell your doctor right away if you have any serious side||
2651|066|S|effects, including: signs of heart failure (such as shortness of||
2651|067|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
2651|068|S|weight gain), signs of lung disease (such as cough, shortness of||
2651|069|S|breath, rapid breathing), signs of skin infection (such as||
2651|070|S|red/peeling/warm skin), signs of muscle damage (such as muscle||
2651|071|S|pain/tenderness/weakness, unusual tiredness), signs of kidney||
2651|072|S|problems (such as change in the amount of urine), easy||
2651|073|S|bleeding/bruising.||
2651|074|S|   Get medical help right away if you have any very serious side||
2651|075|S|effects, including: eye pain/swelling/redness, vision changes||
2651|076|S|(such as blurred vision, loss of vision, blind spots/shadows in||
2651|077|S|the center of your vision, sensitivity to light), signs of||
2651|078|S|bleeding in the brain (such as severe headache, weakness on one||
2651|079|S|side of the body, vision problems, trouble speaking, seizures, or||
2651|080|S|confusion), signs of serious stomach/intestinal problems (such as||
2651|081|S|severe stomach/abdominal pain, black/bloody stools, vomit that||
2651|082|S|contains blood or looks like coffee grounds, diarrhea with||
2651|083|S|blood/mucus), sudden pain/swelling/redness (usually in the leg),||
2651|084|S|chest pain, fast/irregular heartbeat, trouble breathing.||
2651|085|S|   Trametinib may make your blood sugar rise, which can cause or||
2651|086|S|worsen diabetes. Tell your doctor right away if you have symptoms||
2651|087|S|of high blood sugar such as increased thirst/urination. If you||
2651|088|S|already have diabetes, check your blood sugar regularly as||
2651|089|S|directed and share the results with your doctor. Your doctor may||
2651|090|S|need to adjust your diabetes medication, exercise program, or||
2651|091|S|diet.||
2651|092|S|   Although this medication is used to treat certain skin||
2651|093|S|cancers, it may rarely cause new skin cancer or other cancers.||
2651|094|S|Tell your doctor right away if you notice unusual skin changes||
2651|095|S|(such as skin sores/lumps, warts, change in the size/color of a||
2651|096|S|mole, skin bump that bleeds or does not heal). Your doctor should||
2651|097|S|check your skin before starting treatment, every 2 months during||
2651|098|S|treatment, and for up to 6 months after stopping this medication.||
2651|099|S|   Trametinib can commonly cause a rash that is usually not||
2651|100|S|serious. However, you may not be able to tell it apart from a||
2651|101|S|rare rash that could be a sign of a severe reaction. Get medical||
2651|102|S|help right away if you develop any rash.||
2651|103|S|   A very serious allergic reaction to this drug is rare.||
2651|104|S|However, get medical help right away if you notice any symptoms||
2651|105|S|of a serious allergic reaction, including: fever, swollen lymph||
2651|106|S|nodes, rash, itching/swelling (especially of the||
2651|107|S|face/tongue/throat), severe dizziness, trouble breathing.||
2651|108|S|   This is not a complete list of possible side effects. If you||
2651|109|S|notice other effects not listed above, contact your doctor or||
2651|110|S|pharmacist.||
2651|111|S|   In the US -||
2651|112|S|   Call your doctor for medical advice about side effects. You||
2651|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2651|114|S|www.fda.gov/medwatch.||
2651|115|S|   In Canada - Call your doctor for medical advice about side||
2651|116|S|effects. You may report side effects to Health Canada at||
2651|117|S|1-866-234-2345.||
2651|118|B|||
2651|119|P|PRECAUTIONS:  Before taking trametinib, tell your doctor or||
2651|120|P|pharmacist if you are allergic to it; or if you have any other||
2651|121|P|allergies. This product may contain inactive ingredients, which||
2651|122|P|can cause allergic reactions or other problems. Talk to your||
2651|123|P|pharmacist for more details.||
2651|124|P|   Before using this medication, tell your doctor or pharmacist||
2651|125|P|your medical history, especially of: high blood pressure, heart||
2651|126|P|disease (heart failure), lung problems, bleeding/blood problems,||
2651|127|P|diabetes, eye problems, stomach/intestinal problems (such as||
2651|128|P|diverticulitis).||
2651|129|P|   This drug may make you dizzy or cause blurred vision. Alcohol||
2651|130|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
2651|131|P|use machinery, or do anything that needs alertness or clear||
2651|132|P|vision until you can do it safely. Limit alcoholic beverages.||
2651|133|P|Talk to your doctor if you are using marijuana (cannabis).||
2651|134|P|   Before having surgery, tell your doctor or dentist about all||
2651|135|P|the products you use (including prescription drugs,||
2651|136|P|nonprescription drugs, and herbal products).||
2651|137|P|   Older adults may be more sensitive to the side effects of this||
2651|138|P|drug, especially swelling of the arms/legs and loss of appetite.||
2651|139|P|   Tell your doctor if you are pregnant or plan to become||
2651|140|P|pregnant. You should not become pregnant while using trametinib.||
2651|141|P|Trametinib may harm an unborn baby. Your doctor should order a||
2651|142|P|pregnancy test before you start this medication. Women using this||
2651|143|P|medication should ask about reliable forms of birth control||
2651|144|P|during treatment and for 4 months after the last dose. Men||
2651|145|P|(including those who have had a vasectomy) using this medication||
2651|146|P|should ask about reliable forms of birth control during treatment||
2651|147|P|and for 4 months after the last dose. If you or your partner||
2651|148|P|becomes pregnant, talk to your doctor right away about the risks||
2651|149|P|and benefits of this medication.||
2651|150|P|   It is unknown if this drug passes into breast milk. Because of||
2651|151|P|the possible risk to the infant, breastfeeding is not recommended||
2651|152|P|while using this drug and for 4 months after the last dose.||
2651|153|P|Consult your doctor before breastfeeding.||
2651|154|B|||
2651|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2651|156|I|medications work or increase your risk for serious side effects.||
2651|157|I|This document does not contain all possible drug interactions.||
2651|158|I|Keep a list of all the products you use (including||
2651|159|I|prescription/nonprescription drugs and herbal products) and share||
2651|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
2651|161|I|the dosage of any medicines without your doctor's approval.||
2651|162|B|||
2651|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2651|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2651|165|O|poison control center right away. US residents can call||
2651|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2651|167|B|||
2651|168|N|NOTES:  Do not share this medication with others.||
2651|169|N|   Lab and/or medical tests (such as heart imaging, blood||
2651|170|N|pressure, blood sugar, skin checks, weight monitoring in||
2651|171|N|children) should be done before you start taking this medication||
2651|172|N|and while you are taking it. Keep all medical and lab||
2651|173|N|appointments.||
2651|174|B|||
2651|175|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2651|176|D|remember. If it is within 12 hours of the next dose, skip the||
2651|177|D|missed dose. Take your next dose at the regular time. Do not||
2651|178|D|double the dose to catch up.||
2651|179|B|||
2651|180|R|STORAGE:  Store in the original bottle at room temperature or in||
2651|181|R|the refrigerator away from light and moisture. Do not freeze.||
2651|182|R|Keep the bottle upright and tightly close the bottle when not in||
2651|183|R|use. Discard any unused medication 35 days after it has been||
2651|184|R|mixed by your pharmacist. Keep all medications away from children||
2651|185|R|and pets.||
2651|186|R|   Do not flush medications down the toilet or pour them into a||
2651|187|R|drain unless instructed to do so. Properly discard this product||
2651|188|R|when it is expired or no longer needed. Consult your pharmacist||
2651|189|R|or local waste disposal company.||
2651|190|B|||
2651|191|A|Information last revised March 2025.||
2651|192|A|Copyright(c) 2025 First Databank, Inc.||
2651|193|B|||
2652|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2652|002|Z|does NOT have all possible information about this product. This||
2652|003|Z|information does not assure that this product is safe, effective,||
2652|004|Z|or appropriate for you. This information is not individual||
2652|005|Z|medical advice and does not substitute for the advice of your||
2652|006|Z|health care professional. Always ask your health care||
2652|007|Z|professional for complete information about this product and your||
2652|008|Z|specific health needs.||
2652|009|B|||
2652|010|T|REVAKINAGENE IMPLANT - INTRAOCULAR||
2652|011|B|||
2652|012|C|COMMON BRAND NAME(S): Encelto||
2652|013|B|||
2652|014|U|USES:  This medication implant is used to treat a certain eye||
2652|015|U|condition (idiopathic macular telangiectasia type 2 -MacTel).||
2652|016|U|Revakinagene is a small capsule that is placed in the eye to||
2652|017|U|constantly make and release a protein called recombinant human||
2652|018|U|ciliary neurotrophic factor (rhCNTF). This type of treatment is||
2652|019|U|known as gene therapy. Treatment helps protect cells in your eye||
2652|020|U|and slow down vision loss.||
2652|021|B|||
2652|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2652|023|H|from your pharmacist before you start using revakinagene. If you||
2652|024|H|have any questions, ask your doctor or pharmacist.||
2652|025|H|   This medication is an implant placed into the affected eye(s)||
2652|026|H|by a health care professional. The affected eye is numbed before||
2652|027|H|the procedure. Your eye will be monitored before and after||
2652|028|H|placement. To help prevent serious side effects, carefully follow||
2652|029|H|your doctor's instructions after the implant is placed, or after||
2652|030|H|the implant is removed. Use any eye drops exactly as directed by||
2652|031|H|your doctor.||
2652|032|H|   After implant placement, keep water out of the eye for one||
2652|033|H|week. Wear glasses or protective eyewear during the day and an||
2652|034|H|eye shield at night for at least 7 days. Do not do strenuous||
2652|035|H|activities (such as heavy lifting) for 7 days.||
2652|036|H|   Your health care provider should give you an implant card||
2652|037|H|after you receive the implant. Keep the card in a safe place and||
2652|038|H|show it to all your health care provider(s). You may receive an||
2652|039|H|MRI only under very specific conditions if you have this implant.||
2652|040|H|   Tell your doctor if your condition does not get better or if||
2652|041|H|it gets worse.||
2652|042|B|||
2652|043|S|SIDE EFFECTS:  Eye redness/irritation, headache, or dry eye may||
2652|044|S|occur. If any of these effects last or get worse, tell your||
2652|045|S|doctor or pharmacist promptly.||
2652|046|S|   Remember that this medication device has been prescribed||
2652|047|S|because your doctor has judged that the benefit to you is greater||
2652|048|S|than the risk of side effects. Many people using this medication||
2652|049|S|device do not have serious side effects.||
2652|050|S|   Tell your doctor right away if you notice that the implant has||
2652|051|S|moved out of place.||
2652|052|S|   The medication in this device may increase your risk for||
2652|053|S|developing certain serious eye conditions (such as cataracts,||
2652|054|S|endophthalmitis, retinal tear/detachment, hemorrhage, or delayed||
2652|055|S|dark adaptation). Tell your doctor right away if you notice any||
2652|056|S|of these symptoms in the affected eye(s): pain, vision changes||
2652|057|S|(such as decreased vision, blurred vision, flashes of light,||
2652|058|S|seeing new floaters or what looks like spider webs), bleeding or||
2652|059|S|redness in the white of the eye, sensitivity to light, a sudden||
2652|060|S|feeling that something is in your eye, eye discharge, or watering||
2652|061|S|of the eye.||
2652|062|S|   A very serious allergic reaction to this drug is rare.||
2652|063|S|However, get medical help right away if you notice any symptoms||
2652|064|S|of a serious allergic reaction, including: rash, itching/swelling||
2652|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2652|066|S|breathing.||
2652|067|S|   This is not a complete list of possible side effects. If you||
2652|068|S|notice other effects not listed above, contact your doctor or||
2652|069|S|pharmacist.||
2652|070|S|   In the US -||
2652|071|S|   Call your doctor for medical advice about side effects. You||
2652|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2652|073|S|www.fda.gov/medwatch.||
2652|074|S|   In Canada - Call your doctor for medical advice about side||
2652|075|S|effects. You may report side effects to Health Canada at||
2652|076|S|1-866-234-2345.||
2652|077|B|||
2652|078|P|PRECAUTIONS:  Before receiving revakinagene, tell your doctor or||
2652|079|P|pharmacist if you are allergic to it; or if you have any other||
2652|080|P|allergies. This product may contain inactive ingredients, which||
2652|081|P|can cause allergic reactions or other problems. Talk to your||
2652|082|P|pharmacist for more details.||
2652|083|P|   Before using this medication, tell your doctor or pharmacist||
2652|084|P|your medical history, especially of: current/recent eye||
2652|085|P|infection.||
2652|086|P|   This medication may reduce the ability of the eye(s) to adapt||
2652|087|P|from bright lighting conditions to dark lighting conditions||
2652|088|P|(delayed dark adaptation). This may set off vision changes with||
2652|089|P|reduced ability to see clearly (see also Side Effects section).||
2652|090|P|Use flashlights, night-lights, or motion-activated lighting in||
2652|091|P|the dark. Wear sunglasses or tinted lenses in bright||
2652|092|P|environments. Do not drive, use machinery, or do anything that||
2652|093|P|needs clear vision until the eye shield can be removed and you||
2652|094|P|can do those activities safely. Be especially careful when||
2652|095|P|driving because sudden changes in light brightness can happen,||
2652|096|P|which may set off vision changes.||
2652|097|P|   Before having surgery, tell your doctor or dentist about all||
2652|098|P|the products you use (including prescription drugs,||
2652|099|P|nonprescription drugs, and herbal products).||
2652|100|P|   During pregnancy, this medication should be used only when||
2652|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
2652|102|P|   It is unknown if this medication passes into breast milk.||
2652|103|P|Consult your doctor before breastfeeding.||
2652|104|B|||
2652|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2652|106|I|medications work or increase your risk for serious side effects.||
2652|107|I|This document does not contain all possible drug interactions.||
2652|108|I|Keep a list of all the products you use (including||
2652|109|I|prescription/nonprescription drugs and herbal products) and share||
2652|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
2652|111|I|the dosage of any medicines without your doctor's approval.||
2652|112|B|||
2652|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2652|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2652|115|O|poison control center right away. US residents can call||
2652|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2652|117|B|||
2652|118|N|NOTES:  Lab and/or medical tests (such as eye exams) should be||
2652|119|N|done while you are using this medication. Keep all medical and||
2652|120|N|lab appointments. Consult your doctor for more details.||
2652|121|B|||
2652|122|D|MISSED DOSE:  Not applicable.||
2652|123|B|||
2652|124|R|STORAGE:  Not applicable. This type of product is given in a||
2652|125|R|hospital or clinic or doctor's office and will not be stored at||
2652|126|R|home.||
2652|127|B|||
2652|128|A|Information last revised April 2025.||
2652|129|A|Copyright(c) 2025 First Databank, Inc.||
2652|130|B|||
2653|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2653|002|Z|does NOT have all possible information about this product. This||
2653|003|Z|information does not assure that this product is safe, effective,||
2653|004|Z|or appropriate for you. This information is not individual||
2653|005|Z|medical advice and does not substitute for the advice of your||
2653|006|Z|health care professional. Always ask your health care||
2653|007|Z|professional for complete information about this product and your||
2653|008|Z|specific health needs.||
2653|009|B|||
2653|010|T|DIAZOXIDE EXTENDED-RELEASE - ORAL||
2653|011|F|(DYE-az-OX-ide)||
2653|012|B|||
2653|013|C|COMMON BRAND NAME(S): Vykat XR||
2653|014|B|||
2653|015|U|USES:  This medication is used to treat extreme hunger, non-stop||
2653|016|U|thoughts about food, and non-stop need to eat that cannot be||
2653|017|U|satisfied with food (hyperphagia) in people with a certain||
2653|018|U|genetic disorder (Prader-Willi syndrome).||
2653|019|B|||
2653|020|V|OTHER USES:  This section contains uses of this drug that are not||
2653|021|V|listed in the approved professional labeling for the drug but||
2653|022|V|that may be prescribed by your health care professional. Use this||
2653|023|V|drug for a condition that is listed in this section only if it||
2653|024|V|has been so prescribed by your health care professional.||
2653|025|V|   Diazoxide is also available in other brands and forms (such as||
2653|026|V|immediate-release liquid, capsule) to treat very low blood sugar||
2653|027|V|(hypoglycemia). Do not switch between different forms of||
2653|028|V|diazoxide because you may not get the correct dose. Do not take||
2653|029|V|this medication with any other product that contains diazoxide.||
2653|030|B|||
2653|031|H|HOW TO USE:  Read the Medication Guide provided by your||
2653|032|H|pharmacist before you start taking diazoxide and each time you||
2653|033|H|get a refill. If you have any questions, ask your doctor or||
2653|034|H|pharmacist.||
2653|035|H|   Take this medication by mouth with or without food as directed||
2653|036|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2653|037|H|not split, crush, or chew the tablets. Doing so can release all||
2653|038|H|of the drug at once, increasing the risk of side effects. The||
2653|039|H|dosage is based on your medical condition, weight, response to||
2653|040|H|treatment, and other medications you may be taking. Be sure to||
2653|041|H|tell your doctor and pharmacist about all the products you use||
2653|042|H|(including prescription drugs, nonprescription drugs, and herbal||
2653|043|H|products).||
2653|044|H|   To reduce your risk of side effects, your doctor may direct||
2653|045|H|you to start this medication at a low dose and gradually increase||
2653|046|H|your dose. Follow your doctor's instructions carefully.||
2653|047|H|   If you stop taking diazoxide for longer than 7 days, consult||
2653|048|H|your doctor before restarting your medication. Your doctor may||
2653|049|H|direct you to restart this medication at a low dose.||
2653|050|H|   Use this medication regularly to get the most benefit from it.||
2653|051|H|To help you remember, take it at the same time each day. Do not||
2653|052|H|increase your dose or use this drug more often or for longer than||
2653|053|H|prescribed. Your condition will not improve any faster, and your||
2653|054|H|risk of side effects will increase.||
2653|055|H|   Tell your doctor if your condition gets worse.||
2653|056|B|||
2653|057|S|SIDE EFFECTS:  Unusual growth of body hair, especially on the||
2653|058|S|forehead/back/arms/legs, may occur. This is usually not permanent||
2653|059|S|and will go away when the medication is stopped. If this effect||
2653|060|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
2653|061|S|   Remember that this medication has been prescribed because your||
2653|062|S|doctor has judged that the benefit to you is greater than the||
2653|063|S|risk of side effects. Many people using this medication do not||
2653|064|S|have serious side effects.||
2653|065|S|   This medication can cause your body to hold onto salt and||
2653|066|S|water which may lead to serious heart problems. Tell your doctor||
2653|067|S|right away if any of these serious side effects happen to you:||
2653|068|S|swelling of arms/legs/hands/feet, unexplained weight gain,||
2653|069|S|shortness of breath, unusual tiredness.||
2653|070|S|   This medication may make your blood sugar rise, which can||
2653|071|S|cause or worsen diabetes. If you already have diabetes, check||
2653|072|S|your blood sugar regularly as directed and share the results with||
2653|073|S|your doctor. Your doctor may need to adjust your diabetes||
2653|074|S|medication, exercise program, or diet. High blood sugar can be||
2653|075|S|very serious and worsen quickly. Tell your doctor right away if||
2653|076|S|any of these signs of very high blood sugar occur: frequent||
2653|077|S|urination, unusual thirst, nausea/vomiting, abdominal pain,||
2653|078|S|fruity breath odor, deep/rapid breathing, unusual weight loss,||
2653|079|S|unusual weakness/tiredness.||
2653|080|S|   A very serious allergic reaction to this drug is rare.||
2653|081|S|However, get medical help right away if you notice any symptoms||
2653|082|S|of a serious allergic reaction, including: rash, itching/swelling||
2653|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2653|084|S|breathing.||
2653|085|S|   This is not a complete list of possible side effects. If you||
2653|086|S|notice other effects not listed above, contact your doctor or||
2653|087|S|pharmacist.||
2653|088|S|   In the US -||
2653|089|S|   Call your doctor for medical advice about side effects. You||
2653|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2653|091|S|www.fda.gov/medwatch.||
2653|092|S|   In Canada - Call your doctor for medical advice about side||
2653|093|S|effects. You may report side effects to Health Canada at||
2653|094|S|1-866-234-2345.||
2653|095|B|||
2653|096|P|PRECAUTIONS:  Before taking diazoxide, tell your doctor or||
2653|097|P|pharmacist if you are allergic to it; or to other thiazides (such||
2653|098|P|as hydrochlorothiazide); or if you have any other allergies. This||
2653|099|P|product may contain inactive ingredients, which can cause||
2653|100|P|allergic reactions or other problems. Talk to your pharmacist for||
2653|101|P|more details.||
2653|102|P|   Before using this medication, tell your doctor or pharmacist||
2653|103|P|your medical history, especially of: dehydration,||
2653|104|P|diabetes/prediabetes, heart disease (such as heart failure),||
2653|105|P|gout, kidney disease, liver disease, swelling of the arms/legs.||
2653|106|P|   This medication may raise your blood sugar too high under||
2653|107|P|certain conditions. For example, your body may need more insulin||
2653|108|P|while you are under stress due to infection, surgery, or injury.||
2653|109|P|Certain medications (such as corticosteroids like||
2653|110|P|hydrocortisone/prednisone, hormones such as birth control pills)||
2653|111|P|may raise your blood sugar. Your dose may need to be adjusted.||
2653|112|P|Consult your doctor for more details. Tell your doctor right away||
2653|113|P|if any signs of high blood sugar occur (see Side Effects||
2653|114|P|section).||
2653|115|P|   Before having surgery, tell your doctor or dentist about all||
2653|116|P|the products you use (including prescription drugs,||
2653|117|P|nonprescription drugs, and herbal products).||
2653|118|P|   During pregnancy, this medication should be used only when||
2653|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
2653|120|P|   This medication passes into breast milk. Consult your doctor||
2653|121|P|before breastfeeding.||
2653|122|B|||
2653|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2653|124|I|medications work or increase your risk for serious side effects.||
2653|125|I|This document does not contain all possible drug interactions.||
2653|126|I|Keep a list of all the products you use (including||
2653|127|I|prescription/nonprescription drugs and herbal products) and share||
2653|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
2653|129|I|the dosage of any medicines without your doctor's approval.||
2653|130|I|   This medication may interfere with certain lab tests (such as||
2653|131|I|a glucagon test), possibly causing false test results. Make sure||
2653|132|I|lab personnel and all your doctors know you use this drug.||
2653|133|B|||
2653|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2653|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2653|136|O|poison control center right away. US residents can call||
2653|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2653|138|O|Symptoms of overdose may include: frequent urination, unusual||
2653|139|O|thirst, fruity breath odor.||
2653|140|B|||
2653|141|N|NOTES:  Do not share this medication with others.||
2653|142|N|   For best results, this medication should be used along with a||
2653|143|N|doctor-approved diet plan. Consult your doctor for more details.||
2653|144|N|   Lab and/or medical tests (such as fasting blood glucose,||
2653|145|N|hemoglobin A1c) should be done before you start taking this||
2653|146|N|medication and while you are taking it. Keep all medical and lab||
2653|147|N|appointments. Consult your doctor for more details.||
2653|148|B|||
2653|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2653|150|D|remember. If it is near the time of the next dose, skip the||
2653|151|D|missed dose until you call your doctor to discuss what you should||
2653|152|D|do next. Do not double the dose to catch up. See also How to Use||
2653|153|D|section.||
2653|154|B|||
2653|155|R|STORAGE:  Store in the original bottle at room temperature away||
2653|156|R|from light and moisture. Do not store in the bathroom. Keep the||
2653|157|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
2653|158|R|when not in use. Keep all medications away from children and||
2653|159|R|pets.||
2653|160|R|   Do not flush medications down the toilet or pour them into a||
2653|161|R|drain unless instructed to do so. Properly discard this product||
2653|162|R|when it is expired or no longer needed. Consult your pharmacist||
2653|163|R|or local waste disposal company.||
2653|164|B|||
2653|165|A|Information last revised July 2025.||
2653|166|A|Copyright(c) 2025 First Databank, Inc.||
2653|167|B|||
2654|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2654|002|Z|does NOT have all possible information about this product. This||
2654|003|Z|information does not assure that this product is safe, effective,||
2654|004|Z|or appropriate for you. This information is not individual||
2654|005|Z|medical advice and does not substitute for the advice of your||
2654|006|Z|health care professional. Always ask your health care||
2654|007|Z|professional for complete information about this product and your||
2654|008|Z|specific health needs.||
2654|009|B|||
2654|010|T|FITUSIRAN - INJECTION||
2654|011|F|(FIT-ue-SIR-an)||
2654|012|B|||
2654|013|C|COMMON BRAND NAME(S): Qfitlia||
2654|014|B|||
2654|015|W|WARNING:  This medication has caused serious problems from blood||
2654|016|W|clots (such as heart attack, stroke, blood clots in the lungs or||
2654|017|W|legs). You may be at increased risk for blood clots if your||
2654|018|W|antithrombin level becomes too low, if you are using other||
2654|019|W|clotting factors or bypassing agents with this medication, you||
2654|020|W|have a history of blood clots, or if you are immobile (such as on||
2654|021|W|very long plane flights or being bedridden). If you use||
2654|022|W|estrogen-containing products, these may also increase your risk.||
2654|023|W|Before using this medication, if you have any of these conditions||
2654|024|W|report them to your doctor or pharmacist. To reduce your risk,||
2654|025|W|your doctor will order blood clotting tests before you start||
2654|026|W|using this medication and while you are using it. Get medical||
2654|027|W|help right away if any of these side effects occur: shortness of||
2654|028|W|breath/rapid breathing, chest/jaw/left arm pain, unusual||
2654|029|W|sweating, sudden dizziness/fainting, pain/swelling/warmth in the||
2654|030|W|groin/calf, sudden/severe headaches, sudden vision changes,||
2654|031|W|weakness on one side of the body, trouble speaking, or confusion.||
2654|032|W|   Fitusiran may also cause serious problems with your gall||
2654|033|W|bladder. Tell your doctor right away if you have symptoms of||
2654|034|W|stomach/abdominal pain, nausea, or vomiting.||
2654|035|B|||
2654|036|U|USES:  This medication is used by people with a certain inherited||
2654|037|U|bleeding problem (hemophilia A or B) to help prevent or lessen||
2654|038|U|how often they have bleeding problems. This medication works by||
2654|039|U|lowering the levels of a natural protein (antithrombin). This||
2654|040|U|helps produce more clotting protein (thrombin) which helps||
2654|041|U|prevent bleeding.||
2654|042|B|||
2654|043|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
2654|044|H|provided by your pharmacist before you start using this||
2654|045|H|medication and each time you get a refill. Ask your health care||
2654|046|H|professional how to prepare and use this medication. If you have||
2654|047|H|any questions, ask your doctor or pharmacist.||
2654|048|H|   Inject this medication under the skin as directed by your||
2654|049|H|doctor, usually every 1 or 2 months. The injection is given in||
2654|050|H|the upper arms, thighs, or abdomen (except for a 2-inch area||
2654|051|H|around your belly button). The dosage and treatment length are||
2654|052|H|based on your medical condition, antithrombin blood levels, and||
2654|053|H|response to treatment.||
2654|054|H|   Stop the use of other medications used to prevent bleeding||
2654|055|H|(such as Factor VIII, Factor IX, bypassing agents) within 7 days||
2654|056|H|after you start using fitusiran. Ask your healthcare professional||
2654|057|H|for more information about the use of these other products and||
2654|058|H|what to do if you have breakthrough bleeding.||
2654|059|H|   Take the medication out of the refrigerator at least 30||
2654|060|H|minutes before you inject it to allow it to reach room||
2654|061|H|temperature. Do not warm up this medication any other way (for||
2654|062|H|example, do not heat it in the microwave, place it in hot water,||
2654|063|H|or leave it in direct sunlight). Do not shake the medication.||
2654|064|H|Before using, check this product for cloudiness, particles, or||
2654|065|H|discoloration. If you see any of these things, do not use the||
2654|066|H|liquid. Before injecting each dose, clean the skin you are going||
2654|067|H|to inject into (the injection site) with rubbing alcohol. Change||
2654|068|H|the injection site each time to lessen injury under the skin. Do||
2654|069|H|not inject into skin that is tender, bruised, red, or hard. To||
2654|070|H|lessen bruising, do not rub the injection site after a shot.||
2654|071|H|Learn how to store and discard medical supplies safely.||
2654|072|H|   Use this medication regularly to get the most benefit from it.||
2654|073|H|To help you remember, mark your calendar with a reminder.||
2654|074|H|   Do not increase your dose or use this drug more often or for||
2654|075|H|longer than prescribed. Your condition will not improve any||
2654|076|H|faster, and your risk of side effects will increase.||
2654|077|H|   Tell your doctor if your condition does not get better or if||
2654|078|H|it gets worse.||
2654|079|B|||
2654|080|S|SIDE EFFECTS:  See also Warning section.||
2654|081|S|   Redness, pain, or swelling at the injection site may occur.||
2654|082|S|Runny/stuffy nose, sore throat, cough, sneezing, headache,||
2654|083|S|tiredness, or fever may also occur. If any of these effects last||
2654|084|S|or get worse, tell your doctor or pharmacist promptly.||
2654|085|S|   Remember that this medication has been prescribed because your||
2654|086|S|doctor has judged that the benefit to you is greater than the||
2654|087|S|risk of side effects. Many people using this medication do not||
2654|088|S|have serious side effects.||
2654|089|S|   Tell your doctor right away if you have any serious side||
2654|090|S|effects, including: signs of liver disease (such as loss of||
2654|091|S|appetite, yellowing eyes/skin, dark urine).||
2654|092|S|   A very serious allergic reaction to this drug is rare.||
2654|093|S|However, get medical help right away if you notice any symptoms||
2654|094|S|of a serious allergic reaction, including: rash, itching/swelling||
2654|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2654|096|S|breathing.||
2654|097|S|   This is not a complete list of possible side effects. If you||
2654|098|S|notice other effects not listed above, contact your doctor or||
2654|099|S|pharmacist.||
2654|100|S|   In the US -||
2654|101|S|   Call your doctor for medical advice about side effects. You||
2654|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2654|103|S|www.fda.gov/medwatch.||
2654|104|S|   In Canada - Call your doctor for medical advice about side||
2654|105|S|effects. You may report side effects to Health Canada at||
2654|106|S|1-866-234-2345.||
2654|107|B|||
2654|108|P|PRECAUTIONS:  Before using fitusiran, tell your doctor or||
2654|109|P|pharmacist if you are allergic to it; or if you have any other||
2654|110|P|allergies. This product may contain inactive ingredients, which||
2654|111|P|can cause allergic reactions or other problems. Talk to your||
2654|112|P|pharmacist for more details.||
2654|113|P|   Before using this medication, tell your doctor or pharmacist||
2654|114|P|your medical history, especially of: liver disease, gall bladder||
2654|115|P|problems.||
2654|116|P|   Before having surgery, tell your doctor or dentist about all||
2654|117|P|the products you use (including prescription drugs,||
2654|118|P|nonprescription drugs, and herbal products).||
2654|119|P|   During pregnancy, this medication should be used only when||
2654|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
2654|121|P|   It is unknown if this medication passes into breast milk.||
2654|122|P|Consult your doctor before breastfeeding.||
2654|123|B|||
2654|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2654|125|I|medications work or increase your risk for serious side effects.||
2654|126|I|This document does not contain all possible drug interactions.||
2654|127|I|Keep a list of all the products you use (including||
2654|128|I|prescription/nonprescription drugs and herbal products) and share||
2654|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
2654|130|I|the dosage of any medicines without your doctor's approval.||
2654|131|B|||
2654|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2654|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2654|134|O|poison control center right away. US residents can call||
2654|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2654|136|B|||
2654|137|N|NOTES:  Do not share this medication with others.||
2654|138|N|   Lab and/or medical tests (such as blood clotting tests, liver||
2654|139|N|function) should be done before you start using this medication||
2654|140|N|and while you are using it. Keep all medical and lab||
2654|141|N|appointments. Consult your doctor for more details.||
2654|142|B|||
2654|143|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2654|144|D|After that, continue to use this medication once every month or||
2654|145|D|once every 2 months from the date of your last dose. Do not||
2654|146|D|double the dose to catch up. If you have questions about your||
2654|147|D|schedule, ask your doctor or pharmacist.||
2654|148|B|||
2654|149|R|STORAGE:  Different brands of this medication have different||
2654|150|R|storage needs. Check the product package for instructions on how||
2654|151|R|to store your brand, or ask your pharmacist. Keep all medications||
2654|152|R|away from children and pets.||
2654|153|R|   Do not flush medications down the toilet or pour them into a||
2654|154|R|drain unless instructed to do so. Properly discard this product||
2654|155|R|when it is expired or no longer needed. Consult your pharmacist||
2654|156|R|or local waste disposal company.||
2654|157|B|||
2654|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
2654|159|M|medical emergency. For information about enrolling in MedicAlert,||
2654|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2654|161|B|||
2654|162|A|Information last revised April 2025.||
2654|163|A|Copyright(c) 2025 First Databank, Inc.||
2654|164|B|||
2655|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2655|002|Z|does NOT have all possible information about this product. This||
2655|003|Z|information does not assure that this product is safe, effective,||
2655|004|Z|or appropriate for you. This information is not individual||
2655|005|Z|medical advice and does not substitute for the advice of your||
2655|006|Z|health care professional. Always ask your health care||
2655|007|Z|professional for complete information about this product and your||
2655|008|Z|specific health needs.||
2655|009|B|||
2655|010|T|ATRASENTAN - ORAL||
2655|011|B|||
2655|012|C|COMMON BRAND NAME(S): Vanrafia||
2655|013|B|||
2655|014|W|WARNING:  This medication must not be used during pregnancy. It||
2655|015|W|may harm an unborn baby. It is important to prevent pregnancy||
2655|016|W|while taking this medication and for 2 weeks after treatment.||
2655|017|W|Female patients must use reliable birth control before starting||
2655|018|W|treatment, during treatment, and for 2 weeks after the last dose.||
2655|019|W|Ask your doctor which forms of birth control to use while taking||
2655|020|W|this medication. Female patients must take a pregnancy test||
2655|021|W|before starting treatment. If you become pregnant or think you||
2655|022|W|may be pregnant, tell your doctor right away.||
2655|023|B|||
2655|024|U|USES:  This medication is used to lower levels of protein in the||
2655|025|U|urine in people with a certain kidney problem (IgAN - primary||
2655|026|U|immunoglobulin A nephropathy).||
2655|027|B|||
2655|028|H|HOW TO USE:  Read the Medication Guide provided by your||
2655|029|H|pharmacist before you start taking atrasentan and each time you||
2655|030|H|get a refill. If you have any questions, ask your doctor or||
2655|031|H|pharmacist.||
2655|032|H|   Take this medication by mouth with or without food as directed||
2655|033|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
2655|034|H|not crush, chew, or cut the tablets.||
2655|035|H|   Use this medication regularly to get the most benefit from it.||
2655|036|H|To help you remember, take it at the same time each day.||
2655|037|H|   Since this drug can be absorbed through the skin and lungs and||
2655|038|H|may harm an unborn baby, women who are pregnant or who may become||
2655|039|H|pregnant should not handle this medication or breathe the dust||
2655|040|H|from the tablets.||
2655|041|B|||
2655|042|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
2655|043|S|because your doctor has judged that the benefit to you is greater||
2655|044|S|than the risk of side effects. Many people using this medication||
2655|045|S|do not have serious side effects.||
2655|046|S|   Tell your doctor right away if you have any serious side||
2655|047|S|effects, including: signs of liver disease (such as||
2655|048|S|nausea/vomiting that doesn't stop, loss of appetite,||
2655|049|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), unusual||
2655|050|S|weight gain, swelling hands/ankles/feet, unusual tiredness,||
2655|051|S|shortness of breath.||
2655|052|S|   A very serious allergic reaction to this drug is rare.||
2655|053|S|However, get medical help right away if you notice any symptoms||
2655|054|S|of a serious allergic reaction, including: rash, itching/swelling||
2655|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2655|056|S|breathing.||
2655|057|S|   This is not a complete list of possible side effects. If you||
2655|058|S|notice other effects not listed above, contact your doctor or||
2655|059|S|pharmacist.||
2655|060|S|   In the US -||
2655|061|S|   Call your doctor for medical advice about side effects. You||
2655|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2655|063|S|www.fda.gov/medwatch.||
2655|064|S|   In Canada - Call your doctor for medical advice about side||
2655|065|S|effects. You may report side effects to Health Canada at||
2655|066|S|1-866-234-2345.||
2655|067|B|||
2655|068|P|PRECAUTIONS:  Before taking atrasentan, tell your doctor or||
2655|069|P|pharmacist if you are allergic to it; or if you have any other||
2655|070|P|allergies. This product may contain inactive ingredients, which||
2655|071|P|can cause allergic reactions or other problems. Talk to your||
2655|072|P|pharmacist for more details.||
2655|073|P|   Before using this medication, tell your doctor or pharmacist||
2655|074|P|your medical history, especially of: liver problems.||
2655|075|P|   Before having surgery, tell your doctor or dentist about all||
2655|076|P|the products you use (including prescription drugs,||
2655|077|P|nonprescription drugs, and herbal products).||
2655|078|P|   This medication can affect fertility in males. Ask your doctor||
2655|079|P|for more details.||
2655|080|P|   Since this drug can be absorbed through the skin and lungs and||
2655|081|P|may harm an unborn baby, women who are pregnant or who may become||
2655|082|P|pregnant should not handle this medication or breathe the dust||
2655|083|P|from the tablets.||
2655|084|P|   This medication must not be used during pregnancy. It may harm||
2655|085|P|an unborn baby. Discuss the use of reliable forms of birth||
2655|086|P|control (such as condoms, birth control pills) before starting||
2655|087|P|treatment, during treatment, and for 2 weeks after the last dose.||
2655|088|P|If you become pregnant or think you may be pregnant, tell your||
2655|089|P|doctor right away. See also Warning section.||
2655|090|P|   It is unknown if this medication passes into breast milk.||
2655|091|P|Because of the possible risk to the infant, breastfeeding is not||
2655|092|P|recommended while using this medication. Consult your doctor||
2655|093|P|before breastfeeding.||
2655|094|B|||
2655|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2655|096|I|medications work or increase your risk for serious side effects.||
2655|097|I|This document does not contain all possible drug interactions.||
2655|098|I|Keep a list of all the products you use (including||
2655|099|I|prescription/nonprescription drugs and herbal products) and share||
2655|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
2655|101|I|the dosage of any medicines without your doctor's approval.||
2655|102|I|   A product that may interact with this drug is: sparsentan.||
2655|103|I|   Other medications can affect the removal of atrasentan from||
2655|104|I|your body, which may affect how atrasentan works. Examples||
2655|105|I|include cyclosporine, certain macrolide antibiotics (such as||
2655|106|I|clarithromycin, erythromycin), rifamycins (such as rifampin),||
2655|107|I|certain drugs used to treat seizures (such as carbamazepine,||
2655|108|I|phenytoin), St. John's wort, among others.||
2655|109|B|||
2655|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2655|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2655|112|O|poison control center right away. US residents can call||
2655|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2655|114|B|||
2655|115|N|NOTES:  Do not share this medication with others.||
2655|116|N|   Lab and/or medical tests (such as liver/kidney function, urine||
2655|117|N|protein levels, blood pressure, complete blood count) should be||
2655|118|N|done before you start taking this medication and while you are||
2655|119|N|taking it. Keep all medical and lab appointments. Consult your||
2655|120|N|doctor for more details.||
2655|121|B|||
2655|122|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2655|123|D|next dose at the regular time. Do not double the dose to catch||
2655|124|D|up.||
2655|125|B|||
2655|126|R|STORAGE:  Store in the original container at room temperature||
2655|127|R|away from light and moisture. Do not store in the bathroom. Keep||
2655|128|R|the drying agent (desiccant) in the bottle. Tightly close the||
2655|129|R|bottle when not in use. Keep all medications away from children||
2655|130|R|and pets.||
2655|131|R|   Do not flush medications down the toilet or pour them into a||
2655|132|R|drain unless instructed to do so. Properly discard this product||
2655|133|R|when it is expired or no longer needed. Consult your pharmacist||
2655|134|R|or local waste disposal company.||
2655|135|B|||
2655|136|A|Information last revised April 2025.||
2655|137|A|Copyright(c) 2025 First Databank, Inc.||
2655|138|B|||
2656|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2656|002|Z|does NOT have all possible information about this product. This||
2656|003|Z|information does not assure that this product is safe, effective,||
2656|004|Z|or appropriate for you. This information is not individual||
2656|005|Z|medical advice and does not substitute for the advice of your||
2656|006|Z|health care professional. Always ask your health care||
2656|007|Z|professional for complete information about this product and your||
2656|008|Z|specific health needs.||
2656|009|B|||
2656|010|T|NIPOCALIMAB - INJECTION||
2656|011|F|(NIP-oh-KAL-i-mab)||
2656|012|B|||
2656|013|C|COMMON BRAND NAME(S): Imaavy||
2656|014|B|||
2656|015|U|USES:  Nipocalimab is used to treat a certain muscle condition||
2656|016|U|(generalized myasthenia gravis). It may help to improve symptoms||
2656|017|U|of muscle weakness.||
2656|018|B|||
2656|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2656|020|H|from your pharmacist before you start using nipocalimab and each||
2656|021|H|time you get a treatment. If you have any questions, ask your||
2656|022|H|doctor or pharmacist.||
2656|023|H|   This medication is given by injection into a vein by a health||
2656|024|H|care professional. It is given as directed by your doctor,||
2656|025|H|usually once every 2 weeks. The dosage is based on your weight. A||
2656|026|H|healthcare professional should monitor you during each injection||
2656|027|H|and for 30 minutes after the injection to make sure you don't get||
2656|028|H|an allergic reaction.||
2656|029|H|   Infusion reactions may happen during the infusion of this drug||
2656|030|H|and for 2 days afterward. Your doctor may prescribe other||
2656|031|H|medications before each treatment to help prevent these side||
2656|032|H|effects. Tell your doctor right away if you have any symptoms of||
2656|033|H|infusion reactions such as fever, chills, skin redness, rash,||
2656|034|H|tiredness, headache, nausea, or dizziness. Your doctor may give||
2656|035|H|you other medications to help with these side effects or may slow||
2656|036|H|down or stop your treatment for some time.||
2656|037|H|   Use this medication regularly to get the most benefit from it.||
2656|038|H|To help you remember, mark your calendar with a reminder.||
2656|039|H|   Tell your doctor if your condition does not get better or if||
2656|040|H|it gets worse.||
2656|041|B|||
2656|042|S|SIDE EFFECTS:  See also How to Use section.||
2656|043|S|   Swelling hands/ankles/feet, muscle spasms, or dizziness may||
2656|044|S|occur. If any of these effects last or get worse, tell your||
2656|045|S|doctor or pharmacist promptly.||
2656|046|S|   Remember that this medication has been prescribed because your||
2656|047|S|doctor has judged that the benefit to you is greater than the||
2656|048|S|risk of side effects. Many people using this medication do not||
2656|049|S|have serious side effects.||
2656|050|S|   This medication may lower your ability to fight infections.||
2656|051|S|This may make you more likely to get a serious (rarely fatal)||
2656|052|S|infection or make any infection you have worse. Tell your doctor||
2656|053|S|right away if you have any signs of infection (such as sore||
2656|054|S|throat that doesn't go away, fever, chills, cough, blisters,||
2656|055|S|painful/burning urination).||
2656|056|S|   A very serious allergic reaction to this drug is rare.||
2656|057|S|However, get medical help right away if you notice any symptoms||
2656|058|S|of a serious allergic reaction, including: rash, itching/swelling||
2656|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2656|060|S|breathing.||
2656|061|S|   This is not a complete list of possible side effects. If you||
2656|062|S|notice other effects not listed above, contact your doctor or||
2656|063|S|pharmacist.||
2656|064|S|   In the US -||
2656|065|S|   Call your doctor for medical advice about side effects. You||
2656|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2656|067|S|www.fda.gov/medwatch.||
2656|068|S|   In Canada - Call your doctor for medical advice about side||
2656|069|S|effects. You may report side effects to Health Canada at||
2656|070|S|1-866-234-2345.||
2656|071|B|||
2656|072|P|PRECAUTIONS:  Before using nipocalimab, tell your doctor or||
2656|073|P|pharmacist if you are allergic to it; or if you have any other||
2656|074|P|allergies. This product may contain inactive ingredients, which||
2656|075|P|can cause allergic reactions or other problems. Talk to your||
2656|076|P|pharmacist for more details.||
2656|077|P|   Before using this medication, tell your doctor or pharmacist||
2656|078|P|your medical history, especially of: current/recent infection.||
2656|079|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2656|080|P|can make you more dizzy. Do not drive, use machinery, or do||
2656|081|P|anything that needs alertness until you can do it safely. Limit||
2656|082|P|alcoholic beverages. Talk to your doctor if you are using||
2656|083|P|marijuana (cannabis).||
2656|084|P|   Nipocalimab can make you more likely to get infections or may||
2656|085|P|make current infections worse. Stay away from anyone who has an||
2656|086|P|infection that may easily spread (such as chickenpox, COVID-19,||
2656|087|P|measles, flu). Talk to your doctor if you have been exposed to an||
2656|088|P|infection or for more details.||
2656|089|P|   Tell your health care professional that you are using||
2656|090|P|nipocalimab before having any immunizations/vaccinations. Avoid||
2656|091|P|contact with people who have recently received live vaccines||
2656|092|P|(such as flu vaccine inhaled through the nose).||
2656|093|P|   Before having surgery, tell your doctor or dentist about all||
2656|094|P|the products you use (including prescription drugs,||
2656|095|P|nonprescription drugs, and herbal products).||
2656|096|P|   During pregnancy, this medication should be used only when||
2656|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
2656|098|P|   This medication passes into breast milk. Consult your doctor||
2656|099|P|before breastfeeding.||
2656|100|B|||
2656|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2656|102|I|medications work or increase your risk for serious side effects.||
2656|103|I|This document does not contain all possible drug interactions.||
2656|104|I|Keep a list of all the products you use (including||
2656|105|I|prescription/nonprescription drugs and herbal products) and share||
2656|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
2656|107|I|the dosage of any medicines without your doctor's approval.||
2656|108|B|||
2656|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2656|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2656|111|O|poison control center right away. US residents can call||
2656|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2656|113|B|||
2656|114|N|NOTES:  Keep all medical and lab appointments.||
2656|115|B|||
2656|116|D|MISSED DOSE:  It is important to get each dose of this medication||
2656|117|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2656|118|D|right away for a new dosing schedule.||
2656|119|B|||
2656|120|R|STORAGE:  Not applicable. This medication is given in a hospital||
2656|121|R|or clinic and will not be stored at home.||
2656|122|B|||
2656|123|M|MEDICAL ALERT:  Your condition can cause complications in a||
2656|124|M|medical emergency. For information about enrolling in MedicAlert,||
2656|125|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2656|126|B|||
2656|127|A|Information last revised May 2025.||
2656|128|A|Copyright(c) 2025 First Databank, Inc.||
2656|129|B|||
2657|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2657|002|Z|does NOT have all possible information about this product. This||
2657|003|Z|information does not assure that this product is safe, effective,||
2657|004|Z|or appropriate for you. This information is not individual||
2657|005|Z|medical advice and does not substitute for the advice of your||
2657|006|Z|health care professional. Always ask your health care||
2657|007|Z|professional for complete information about this product and your||
2657|008|Z|specific health needs.||
2657|009|B|||
2657|010|T|RILPIVIRINE TABLET - FOR ORAL SUSPENSION||
2657|011|F|(RIL-pi-VIR-een)||
2657|012|B|||
2657|013|C|COMMON BRAND NAME(S): Edurant Ped||
2657|014|B|||
2657|015|U|USES:  Rilpivirine is used with other HIV medications to help||
2657|016|U|control HIV infection. It helps to decrease the amount of HIV in||
2657|017|U|your body so your immune system can work better. This lowers your||
2657|018|U|chance of getting HIV complications (such as new infections,||
2657|019|U|cancer) and improves your quality of life. Rilpivirine is a||
2657|020|U|non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks||
2657|021|U|the virus from growing and infecting more cells.||
2657|022|U|   Rilpivirine is not a cure for HIV infection. To decrease your||
2657|023|U|risk of spreading HIV disease to others, continue to take all HIV||
2657|024|U|medications exactly as prescribed by your doctor. Use an||
2657|025|U|effective barrier method (latex or polyurethane condoms/dental||
2657|026|U|dams) during sexual activity as directed by your doctor. Do not||
2657|027|U|share personal items (such as needles/syringes, toothbrushes, and||
2657|028|U|razors) that may have contacted blood or other body fluids.||
2657|029|U|Consult your doctor or pharmacist for more details.||
2657|030|U|   This form of rilpivirine should only be used by children.||
2657|031|B|||
2657|032|V|OTHER USES:  This section contains uses of this drug that are not||
2657|033|V|listed in the approved professional labeling for the drug but||
2657|034|V|that may be prescribed by your health care professional. Use this||
2657|035|V|drug for a condition that is listed in this section only if it||
2657|036|V|has been so prescribed by your health care professional.||
2657|037|V|   This product may also be used to lessen the risk of HIV||
2657|038|V|infection after contact with the virus (for example, due to a||
2657|039|V|needle stick). Ask your doctor for more details.||
2657|040|B|||
2657|041|H|HOW TO USE:  Read the Patient Information Leaflet and||
2657|042|H|Instructions for Use if available from your pharmacist before you||
2657|043|H|start using rilpivirine and each time you get a refill. If you||
2657|044|H|have any questions, ask your doctor or pharmacist.||
2657|045|H|   Do not change dosage forms of this medication without checking||
2657|046|H|with your doctor or pharmacist.||
2657|047|H|   Take this medication by mouth with a meal as directed by your||
2657|048|H|doctor, usually once daily. The dosage is based on weight.||
2657|049|H|   Carefully remove the tablets from the blister pack. Do not||
2657|050|H|push the tablets through the foil. Do not chew, crush, or swallow||
2657|051|H|the tablets whole. Place the tablets in a cup and add one||
2657|052|H|teaspoon (5 milliliters) of room temperature water to the cup.||
2657|053|H|Swirl the cup for 1 to 2 minutes to dissolve the tablets. Take||
2657|054|H|the mixture right away. To help with taking the mixture, you may||
2657|055|H|also add another teaspoon (5 milliliters) of liquid (such as||
2657|056|H|water, milk, orange juice) or apple sauce as directed before||
2657|057|H|taking. If there is any medicine left in the cup after taking the||
2657|058|H|mixture, add another teaspoon (5 milliliters) of water or other||
2657|059|H|liquid to the cup, swirl, and drink the mixture right away.||
2657|060|H|Prepared medication that is not used right away should be thrown||
2657|061|H|away and a new dose should be prepared.||
2657|062|H|   Medications that reduce stomach acid (such as antacids, proton||
2657|063|H|pump inhibitors/PPIs, H2 blockers) may make rilpivirine work less||
2657|064|H|well. Do not take PPIs (such as lansoprazole, omeprazole) while||
2657|065|H|using this medication. If you take antacids, take the antacids at||
2657|066|H|least 2 hours before or at least 4 hours after rilpivirine. If||
2657|067|H|you take H2 blockers (such as famotidine, nizatidine), take them||
2657|068|H|at least 12 hours before or at least 4 hours after rilpivirine.||
2657|069|H|   It is very important to keep taking this medication (and other||
2657|070|H|HIV medications) exactly as prescribed by your doctor. Do not||
2657|071|H|skip any doses.||
2657|072|H|   For the best effect, take this medication at evenly spaced||
2657|073|H|times. To help you remember, take this medication at the same||
2657|074|H|time every day.||
2657|075|H|   Do not take more or less of this drug than prescribed or stop||
2657|076|H|taking it (or other HIV medicines) even for a short time unless||
2657|077|H|directed to do so by your doctor. Doing so may cause the amount||
2657|078|H|of virus to increase, make the infection more difficult to treat||
2657|079|H|(resistant), or worsen side effects.||
2657|080|B|||
2657|081|S|SIDE EFFECTS:  Headache or trouble sleeping may occur. If either||
2657|082|S|of these effects lasts or gets worse, tell your doctor or||
2657|083|S|pharmacist promptly.||
2657|084|S|   Remember that this medication has been prescribed because your||
2657|085|S|doctor has judged that the benefit to you is greater than the||
2657|086|S|risk of side effects. Many people using this medication do not||
2657|087|S|have serious side effects.||
2657|088|S|   As your immune system gets stronger, it can begin to fight off||
2657|089|S|infections you already had, possibly causing disease symptoms to||
2657|090|S|come back. You could also have symptoms if your immune system||
2657|091|S|becomes overactive. This reaction may happen at any time (soon||
2657|092|S|after starting HIV treatment or many months later). Tell your||
2657|093|S|doctor right away if you have any serious symptoms, including:||
2657|094|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
2657|095|S|that doesn't go away, headaches that are severe or don't go away,||
2657|096|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
2657|097|S|changes, signs of infection (such as sore throat that doesn't go||
2657|098|S|away, fever, chills, non-healing skin sores), signs of an||
2657|099|S|overactive thyroid (such as irritability, nervousness, heat||
2657|100|S|intolerance, fast/pounding/irregular heartbeat), signs of liver||
2657|101|S|disease (such as nausea/vomiting that doesn't stop, loss of||
2657|102|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2657|103|S|urine).||
2657|104|S|   Tell your doctor right away if you have any serious side||
2657|105|S|effects, including: mental/mood changes (such as depression,||
2657|106|S|thoughts of suicide).||
2657|107|S|   Rilpivirine can commonly cause a rash that is usually not||
2657|108|S|serious. However, you may not be able to tell it apart from a||
2657|109|S|rare rash that could be a sign of a severe reaction. Get medical||
2657|110|S|help right away if you develop any rash.||
2657|111|S|   A very serious allergic reaction to this drug is rare.||
2657|112|S|However, get medical help right away if you notice any symptoms||
2657|113|S|of a serious allergic reaction, including: swollen lymph nodes,||
2657|114|S|rash, itching/swelling (especially of the face/tongue/throat),||
2657|115|S|severe dizziness, trouble breathing.||
2657|116|S|   This is not a complete list of possible side effects. If you||
2657|117|S|notice other effects not listed above, contact your doctor or||
2657|118|S|pharmacist.||
2657|119|S|   In the US -||
2657|120|S|   Call your doctor for medical advice about side effects. You||
2657|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2657|122|S|www.fda.gov/medwatch.||
2657|123|S|   In Canada - Call your doctor for medical advice about side||
2657|124|S|effects. You may report side effects to Health Canada at||
2657|125|S|1-866-234-2345.||
2657|126|B|||
2657|127|P|PRECAUTIONS:  Before taking rilpivirine, tell your doctor or||
2657|128|P|pharmacist if you are allergic to it; or if you have any other||
2657|129|P|allergies. This product may contain inactive ingredients, which||
2657|130|P|can cause allergic reactions or other problems. Talk to your||
2657|131|P|pharmacist for more details.||
2657|132|P|   Before using this medication, tell your doctor or pharmacist||
2657|133|P|your medical history, especially of: kidney disease, liver||
2657|134|P|disease (such as hepatitis B, hepatitis C), mental/mood disorders||
2657|135|P|(such as depression).||
2657|136|P|   Before having surgery, tell your doctor or dentist about all||
2657|137|P|the products you use (including prescription drugs,||
2657|138|P|nonprescription drugs, and herbal products).||
2657|139|P|   Tell your doctor if you are pregnant before using this||
2657|140|P|medication. Treatment can lower the risk of passing HIV infection||
2657|141|P|to your baby, and rilpivirine may be part of that treatment.||
2657|142|P|Discuss the risks and benefits with your doctor.||
2657|143|P|   This medication passes into breast milk. Because breast milk||
2657|144|P|may transmit HIV, consult your doctor before breastfeeding.||
2657|145|B|||
2657|146|I|DRUG INTERACTIONS:  See also How to Use section.||
2657|147|I|   Drug interactions may change how your medications work or||
2657|148|I|increase your risk for serious side effects. This document does||
2657|149|I|not contain all possible drug interactions. Keep a list of all||
2657|150|I|the products you use (including prescription/nonprescription||
2657|151|I|drugs and herbal products) and share it with your doctor and||
2657|152|I|pharmacist. Do not start, stop, or change the dosage of any||
2657|153|I|medicines without your doctor's approval.||
2657|154|I|   Some products that may interact with this drug are: orlistat,||
2657|155|I|other HIV NNRTIs (such as efavirenz, nevirapine), a certain||
2657|156|I|combination HIV medication||
2657|157|I|(elvitegravir/cobicistat/emtricitabine/tenofovir), proton pump||
2657|158|I|inhibitors (PPIs such as esomeprazole, lansoprazole, omeprazole,||
2657|159|I|pantoprazole, rabeprazole).||
2657|160|I|   Other medications can affect the removal of rilpivirine from||
2657|161|I|your body, which may affect how rilpivirine works. Examples||
2657|162|I|include dexamethasone, macrolide antibiotics (such as||
2657|163|I|erythromycin), rifamycins (such as rifampin, rifapentine), St.||
2657|164|I|John's wort, certain drugs used to treat seizures (such as||
2657|165|I|carbamazepine, oxcarbazepine, phenobarbital, phenytoin,||
2657|166|I|primidone), among others.||
2657|167|B|||
2657|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2657|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2657|170|O|poison control center right away. US residents can call||
2657|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2657|172|O|Symptoms of overdose may include: fast/irregular heartbeat,||
2657|173|O|severe dizziness, fainting.||
2657|174|B|||
2657|175|N|NOTES:  Do not share this medication with others.||
2657|176|N|   Lab and/or medical tests (such as viral load, T-cell counts,||
2657|177|N|liver function) should be done before you start taking this||
2657|178|N|medication and while you are taking it. Keep all medical and lab||
2657|179|N|appointments. Consult your doctor for more details.||
2657|180|B|||
2657|181|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
2657|182|D|you remember. If it is more than 12 hours after the missed dose,||
2657|183|D|skip the missed dose. Take your next dose at the regular time. Do||
2657|184|D|not double the dose to catch up.||
2657|185|B|||
2657|186|R|STORAGE:  Store at room temperature away from light and moisture.||
2657|187|R|Keep the medication in the original blister pack until ready to||
2657|188|R|use. Do not store in the bathroom. Keep all medications away from||
2657|189|R|children and pets.||
2657|190|R|   Do not flush medications down the toilet or pour them into a||
2657|191|R|drain unless instructed to do so. Properly discard this product||
2657|192|R|when it is expired or no longer needed. Consult your pharmacist||
2657|193|R|or local waste disposal company.||
2657|194|B|||
2657|195|A|Information last revised June 2025.||
2657|196|A|Copyright(c) 2025 First Databank, Inc.||
2657|197|B|||
2658|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2658|002|Z|does NOT have all possible information about this product. This||
2658|003|Z|information does not assure that this product is safe, effective,||
2658|004|Z|or appropriate for you. This information is not individual||
2658|005|Z|medical advice and does not substitute for the advice of your||
2658|006|Z|health care professional. Always ask your health care||
2658|007|Z|professional for complete information about this product and your||
2658|008|Z|specific health needs.||
2658|009|B|||
2658|010|T|AVUTOMETINIB CAPSULE/DEFACTINIB TABLET KIT - ORAL||
2658|011|B|||
2658|012|C|COMMON BRAND NAME(S): Avmapki Fakzynja Co-Pack||
2658|013|B|||
2658|014|U|USES:  This product is used to treat ovarian cancer. This product||
2658|015|U|has 2 different types of medications. The capsule contains||
2658|016|U|avutometinib. The tablet contains defactinib. Avutometinib and||
2658|017|U|defactinib belong to a class of drugs known as kinase inhibitors.||
2658|018|U|They work by slowing or stopping the growth of cancer cells.||
2658|019|B|||
2658|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2658|021|H|from your pharmacist before you start taking this product and||
2658|022|H|each time you get a refill. If you have any questions, ask your||
2658|023|H|doctor or pharmacist.||
2658|024|H|   Take avutometinib by mouth with food as directed by your||
2658|025|H|doctor, usually twice a week (about 3 days apart) for 3 weeks,||
2658|026|H|then stopping avutometinib for 7 days. This is one cycle of||
2658|027|H|treatment. Keep taking avutometinib this way as directed by your||
2658|028|H|doctor. Swallow the capsules whole. Do not crush, break, or open||
2658|029|H|the capsules.||
2658|030|H|   Take defactinib by mouth with food as directed by your doctor,||
2658|031|H|usually twice a day (about 12 hours apart) for 21 days, then||
2658|032|H|stopping defactinib for 7 days. This is one cycle of treatment.||
2658|033|H|Keep taking defactinib this way as directed by your doctor.||
2658|034|H|Swallow the tablets whole. Do not crush, break, or chew the||
2658|035|H|tablets.||
2658|036|H|   If you vomit after taking a dose, do not take another dose at||
2658|037|H|that time. Take your next dose at the regular time.||
2658|038|H|   The dosage is based on your medical condition and response to||
2658|039|H|treatment.||
2658|040|H|   Your doctor may prescribe other medications (such as||
2658|041|H|corticosteroids, antibiotics) to help prevent side effects on the||
2658|042|H|skin. Consult your doctor or pharmacist for more details.||
2658|043|H|   Use this product regularly to get the most benefit from it. To||
2658|044|H|help you remember, mark your calendar with a reminder.||
2658|045|H|   Do not increase your dose or use this product more often or||
2658|046|H|for longer than prescribed. Your condition will not improve any||
2658|047|H|faster, and your risk of side effects will increase.||
2658|048|H|   Medications that reduce stomach acid (such as antacids, proton||
2658|049|H|pump inhibitors/PPIs, H2 blockers) may make defactinib work less||
2658|050|H|well. Do not take PPIs (such as lansoprazole, omeprazole) or H2||
2658|051|H|blockers (such as famotidine, nizatidine) while using this||
2658|052|H|medication. If you take antacids, take defactinib 2 hours before||
2658|053|H|or 2 hours after taking the antacid.||
2658|054|H|   Since this product can be absorbed through the skin and lungs||
2658|055|H|and may harm an unborn baby, women who are pregnant or who may||
2658|056|H|become pregnant should not handle this product or breathe the||
2658|057|H|dust from this product.||
2658|058|B|||
2658|059|S|SIDE EFFECTS:  Dry/itchy skin, skin bumps, dry eyes, mouth sores,||
2658|060|S|heartburn, diarrhea, nausea, vomiting, muscle/joint pain,||
2658|061|S|tiredness, or dizziness may occur. If any of these effects last||
2658|062|S|or get worse, tell your doctor or pharmacist promptly.||
2658|063|S|   Remember that this product has been prescribed because your||
2658|064|S|doctor has judged that the benefit to you is greater than the||
2658|065|S|risk of side effects. Many people using this product do not have||
2658|066|S|serious side effects.||
2658|067|S|   Tell your doctor right away if you have any serious side||
2658|068|S|effects, including: vision changes (such as blurred vision, loss||
2658|069|S|of vision), eye pain/redness/swelling, signs of liver disease||
2658|070|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
2658|071|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2658|072|S|of muscle damage (such as muscle pain/tenderness/weakness, fever,||
2658|073|S|unusual tiredness, change in the amount of urine).||
2658|074|S|   Avutometinib and defactinib can commonly cause a rash that is||
2658|075|S|usually not serious. However, you may not be able to tell it||
2658|076|S|apart from a rare rash that could be a sign of a severe reaction.||
2658|077|S|Tell your doctor right away if you develop any rash.||
2658|078|S|   A very serious allergic reaction to this product is rare.||
2658|079|S|However, get medical help right away if you notice any symptoms||
2658|080|S|of a serious allergic reaction, including: fever, swollen lymph||
2658|081|S|nodes, rash, itching/swelling (especially of the||
2658|082|S|face/tongue/throat), severe dizziness, trouble breathing.||
2658|083|S|   This is not a complete list of possible side effects. If you||
2658|084|S|notice other effects not listed above, contact your doctor or||
2658|085|S|pharmacist.||
2658|086|S|   In the US -||
2658|087|S|   Call your doctor for medical advice about side effects. You||
2658|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2658|089|S|www.fda.gov/medwatch.||
2658|090|S|   In Canada - Call your doctor for medical advice about side||
2658|091|S|effects. You may report side effects to Health Canada at||
2658|092|S|1-866-234-2345.||
2658|093|B|||
2658|094|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2658|095|P|pharmacist if you are allergic to avutometinib or defactinib; or||
2658|096|P|if you have any other allergies. This product may contain||
2658|097|P|inactive ingredients, which can cause allergic reactions or other||
2658|098|P|problems. Talk to your pharmacist for more details.||
2658|099|P|   Before using this product, tell your doctor or pharmacist your||
2658|100|P|medical history, especially of: liver problems, eye problems.||
2658|101|P|   This product may make you dizzy or cause blurred vision.||
2658|102|P|Alcohol or marijuana (cannabis) can worsen these effects. Do not||
2658|103|P|drive, use machinery, or do anything that needs alertness until||
2658|104|P|you can do it safely. Limit alcoholic beverages. Talk to your||
2658|105|P|doctor if you are using marijuana (cannabis).||
2658|106|P|   This product may make you more sensitive to the sun. Limit||
2658|107|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
2658|108|P|sunscreen and wear protective clothing when outdoors. Tell your||
2658|109|P|doctor right away if you get sunburned or have skin||
2658|110|P|blisters/redness.||
2658|111|P|   Before having surgery, tell your doctor or dentist about all||
2658|112|P|the products you use (including prescription drugs,||
2658|113|P|nonprescription drugs, and herbal products).||
2658|114|P|   Since this product can be absorbed through the skin and lungs||
2658|115|P|and may harm an unborn baby, women who are pregnant or who may||
2658|116|P|become pregnant should not handle this product or breathe the||
2658|117|P|dust from this product.||
2658|118|P|   Tell your doctor if you are pregnant or plan to become||
2658|119|P|pregnant. You should not become pregnant while using avutometinib||
2658|120|P|and defactinib. Avutometinib and defactinib may harm an unborn||
2658|121|P|baby. Your doctor should order a pregnancy test before you start||
2658|122|P|this product. Women using this product should ask about reliable||
2658|123|P|forms of birth control during treatment and for 1 month after the||
2658|124|P|last dose. Men using this product should ask about reliable forms||
2658|125|P|of birth control during treatment and for 4 months after the last||
2658|126|P|dose. If you or your partner becomes pregnant, talk to your||
2658|127|P|doctor right away about the risks and benefits of this product.||
2658|128|P|   It is unknown if this product passes into breast milk. Because||
2658|129|P|of the possible risk to the infant, breastfeeding is not||
2658|130|P|recommended while using this product and for 2 weeks after the||
2658|131|P|last dose. Consult your doctor before breastfeeding.||
2658|132|B|||
2658|133|I|DRUG INTERACTIONS:  See also How to Use section.||
2658|134|I|   Drug interactions may change how your medications work or||
2658|135|I|increase your risk for serious side effects. This document does||
2658|136|I|not contain all possible drug interactions. Keep a list of all||
2658|137|I|the products you use (including prescription/nonprescription||
2658|138|I|drugs and herbal products) and share it with your doctor and||
2658|139|I|pharmacist. Do not start, stop, or change the dosage of any||
2658|140|I|medicines without your doctor's approval.||
2658|141|I|   Other medications can affect the removal of defactinib from||
2658|142|I|your body, which may affect how defactinib works. Examples||
2658|143|I|include azole antifungals (such as itraconazole), macrolide||
2658|144|I|antibiotics (such as erythromycin), rifamycins (such as||
2658|145|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
2658|146|I|as carbamazepine, phenytoin), among others.||
2658|147|B|||
2658|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2658|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2658|150|O|poison control center right away. US residents can call||
2658|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2658|152|B|||
2658|153|N|NOTES:  Do not share this medication with others.||
2658|154|N|   Lab and/or medical tests (such as liver function, eye exams,||
2658|155|N|CPK levels) should be done before you start taking this product||
2658|156|N|and while you are taking it. Keep all medical and lab||
2658|157|N|appointments. Consult your doctor for more details.||
2658|158|B|||
2658|159|D|MISSED DOSE:  If you miss a dose of avutometinib, take it as soon||
2658|160|D|as you remember. If it is more than 24 hours after the missed||
2658|161|D|dose, skip the missed dose. Take your next dose at the regular||
2658|162|D|time. Do not double the dose to catch up.||
2658|163|D|   If you miss a dose of defactinib, take it as soon as you||
2658|164|D|remember. If it is more than 6 hours after the missed dose, skip||
2658|165|D|the missed dose. Take your next dose at the regular time. Do not||
2658|166|D|double the dose to catch up.||
2658|167|B|||
2658|168|R|STORAGE:  Store in the original bottle in the refrigerator. Keep||
2658|169|R|all medications away from children and pets.||
2658|170|R|   Do not flush medications down the toilet or pour them into a||
2658|171|R|drain unless instructed to do so. Properly discard this product||
2658|172|R|when it is expired or no longer needed. Consult your pharmacist||
2658|173|R|or local waste disposal company.||
2658|174|B|||
2658|175|A|Information last revised May 2025.||
2658|176|A|Copyright(c) 2025 First Databank, Inc.||
2658|177|B|||
2659|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2659|002|Z|does NOT have all possible information about this product. This||
2659|003|Z|information does not assure that this product is safe, effective,||
2659|004|Z|or appropriate for you. This information is not individual||
2659|005|Z|medical advice and does not substitute for the advice of your||
2659|006|Z|health care professional. Always ask your health care||
2659|007|Z|professional for complete information about this product and your||
2659|008|Z|specific health needs.||
2659|009|B|||
2659|010|T|COPPER-RELEASING 3 YEAR SYSTEM - INTRAUTERINE||
2659|011|B|||
2659|012|C|COMMON BRAND NAME(S): Miudella||
2659|013|B|||
2659|014|U|USES:  This product is a small, flexible device that is placed in||
2659|015|U|the womb (uterus) to prevent pregnancy. It is used by people who||
2659|016|U|want a reversible birth control method that works for a long time||
2659|017|U|(up to 3 years). This device helps prevent pregnancy.||
2659|018|U|   This product does not protect against sexually transmitted||
2659|019|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
2659|020|U|an effective barrier method (latex or polyurethane condom/dental||
2659|021|U|dams) during sexual activity will help to decrease your risk of||
2659|022|U|infection.||
2659|023|B|||
2659|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2659|025|H|from your pharmacist before you start using this product. If you||
2659|026|H|have any questions, ask your doctor or pharmacist.||
2659|027|H|   This device is placed in your uterus by a health care provider||
2659|028|H|during an in-office visit. It is left in place for up to 3 years.||
2659|029|H|After the device is placed, schedule a follow-up visit after your||
2659|030|H|first menstrual period to make sure it is still in the proper||
2659|031|H|position.||
2659|032|H|   This device may sometimes move out of place or come out by||
2659|033|H|itself. It is a good habit to check once a month to make sure it||
2659|034|H|is in the proper position. Learn how to carefully check the||
2659|035|H|position of this device from the Patient Information Leaflet||
2659|036|H|and/or your health care provider. If it comes out or if you||
2659|037|H|cannot feel the threads, contact your doctor promptly and use||
2659|038|H|backup birth control (such as condoms, spermicide) to prevent||
2659|039|H|pregnancy until otherwise directed by your doctor.||
2659|040|H|   If you wish to continue this method of birth control after 3||
2659|041|H|years, the used device may be removed and replaced with a new||
2659|042|H|one. Either way, the used device should be removed after 3 years.||
2659|043|H|Your health care provider can remove this device whenever you||
2659|044|H|want to stop using this method of birth control.||
2659|045|B|||
2659|046|S|SIDE EFFECTS:  Temporary pain, bleeding, or dizziness during and||
2659|047|S|soon after placement of the device may occur. Your periods may||
2659|048|S|become heavier and longer. You may also have frequent vaginal||
2659|049|S|bleeding (spotting) between periods. If any of these effects last||
2659|050|S|or get worse, tell your doctor promptly.||
2659|051|S|   Remember that this medication device has been prescribed||
2659|052|S|because your doctor has judged that the benefit to you is greater||
2659|053|S|than the risk of side effects. Many people using this device do||
2659|054|S|not have serious side effects.||
2659|055|S|   Tell your doctor right away if you have any serious side||
2659|056|S|effects, including: unusual changes in vaginal bleeding (such as||
2659|057|S|continuous spotting, sudden heavy bleeding, missed periods).||
2659|058|S|   Using an intrauterine device (IUD) may increase your risk for||
2659|059|S|a rare but serious pelvic infection (pelvic inflammatory||
2659|060|S|disease-PID), which can cause permanent damage to sex organs and||
2659|061|S|infertility. The risk is greater in people who have multiple||
2659|062|S|sexual partners, or infection with a sexually transmitted disease||
2659|063|S|(STD), or who have had PID in the past (see also Precautions||
2659|064|S|section). Tell your doctor right away if you have symptoms of||
2659|065|S|PID, including: unexplained fever/chills, lower abdominal/pelvic||
2659|066|S|pain, pain during sexual intercourse, genital sores, unusual||
2659|067|S|vaginal discharge.||
2659|068|S|   A very serious allergic reaction to this drug is rare.||
2659|069|S|However, get medical help right away if you notice any symptoms||
2659|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2659|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2659|072|S|breathing.||
2659|073|S|   This is not a complete list of possible side effects. If you||
2659|074|S|notice other effects not listed above, contact your doctor or||
2659|075|S|pharmacist.||
2659|076|S|   In the US -||
2659|077|S|   Call your doctor for medical advice about side effects. You||
2659|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2659|079|S|www.fda.gov/medwatch.||
2659|080|S|   In Canada - Call your doctor for medical advice about side||
2659|081|S|effects. You may report side effects to Health Canada at||
2659|082|S|1-866-234-2345.||
2659|083|B|||
2659|084|P|PRECAUTIONS:  Before using this medication device, tell your||
2659|085|P|doctor or pharmacist if you are allergic to copper; or to nickel||
2659|086|P|or titanium; or if you have any other allergies. This product may||
2659|087|P|contain inactive ingredients, which can cause allergic reactions||
2659|088|P|or other problems. Talk to your pharmacist for more details.||
2659|089|P|   Before using this product, tell your doctor or pharmacist your||
2659|090|P|medical history, especially of: recent pregnancy, current||
2659|091|P|breastfeeding, cancer (especially uterine or cervical cancer),||
2659|092|P|unexplained vaginal bleeding, uterus problems (such as fibroids,||
2659|093|P|pelvic inflammatory disease-PID), Wilson's disease (a disorder in||
2659|094|P|how the body handles copper), conditions that weaken the immune||
2659|095|P|system/increase the risk of infection (such as HIV, leukemia, IV||
2659|096|P|drug abuse).||
2659|097|P|   If you or partner have other sexual partners, this device may||
2659|098|P|not be the best birth control method for you. If you or your||
2659|099|P|partner(s) get a sexually transmitted disease (including HIV,||
2659|100|P|gonorrhea, chlamydia), contact your doctor right away. Ask your||
2659|101|P|doctor if you should continue to use this device for birth||
2659|102|P|control.||
2659|103|P|   Before having surgery, tell your doctor or dentist about all||
2659|104|P|the products you use (including prescription drugs,||
2659|105|P|nonprescription drugs, and herbal products). Also, if you are||
2659|106|P|going to have a medical procedure using heat therapy or an MRI||
2659|107|P|test, tell your healthcare provider and testing personnel that||
2659|108|P|you are using this device. Your procedure or MRI test may need to||
2659|109|P|be adjusted.||
2659|110|P|   This device should not be used during pregnancy. If you become||
2659|111|P|pregnant or think you may be pregnant, tell your doctor right||
2659|112|P|away.||
2659|113|P|   It is unknown if the copper in this device passes into breast||
2659|114|P|milk. However, it is unlikely to pass into breast milk. Consult||
2659|115|P|your doctor before breastfeeding.||
2659|116|B|||
2659|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2659|118|I|medications work or increase your risk for serious side effects.||
2659|119|I|This document does not contain all possible drug interactions.||
2659|120|I|Keep a list of all the products you use (including||
2659|121|I|prescription/nonprescription drugs and herbal products) and share||
2659|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
2659|123|I|the dosage of any medicines without your doctor's approval.||
2659|124|B|||
2659|125|O|OVERDOSE:  This medication device may be harmful if swallowed. If||
2659|126|O|someone has swallowed it and has serious symptoms such as passing||
2659|127|O|out or trouble breathing, call 911. Otherwise, call a poison||
2659|128|O|control center right away. US residents can call 1-800-222-1222.||
2659|129|O|Canada residents can call 1-844-764-7669.||
2659|130|B|||
2659|131|N|NOTES:  You should have regular complete physical exams including||
2659|132|N|pelvic exam and screening for cervical cancer (Pap smear). Keep||
2659|133|N|all medical and lab appointments. Consult your doctor for more||
2659|134|N|details.||
2659|135|B|||
2659|136|D|MISSED DOSE:  Not applicable.||
2659|137|B|||
2659|138|R|STORAGE:  Before use, store at room temperature. Keep all||
2659|139|R|medications and medical devices away from children and pets.||
2659|140|R|   Do not flush medications down the toilet or pour them into a||
2659|141|R|drain unless instructed to do so. Properly discard this product||
2659|142|R|when it is expired or no longer needed. Consult your pharmacist||
2659|143|R|or local waste disposal company.||
2659|144|B|||
2659|145|A|Information last revised October 2025.||
2659|146|A|Copyright(c) 2025 First Databank, Inc.||
2659|147|B|||
2660|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2660|002|Z|does NOT have all possible information about this product. This||
2660|003|Z|information does not assure that this product is safe, effective,||
2660|004|Z|or appropriate for you. This information is not individual||
2660|005|Z|medical advice and does not substitute for the advice of your||
2660|006|Z|health care professional. Always ask your health care||
2660|007|Z|professional for complete information about this product and your||
2660|008|Z|specific health needs.||
2660|009|B|||
2660|010|T|MARALIXIBAT TABLET - ORAL||
2660|011|F|(MAR-a-LIX-i-bat)||
2660|012|B|||
2660|013|C|COMMON BRAND NAME(S): Livmarli||
2660|014|B|||
2660|015|U|USES:  This medication is used to treat skin itching caused by||
2660|016|U|certain inherited liver conditions (progressive familial||
2660|017|U|intrahepatic cholestasis-PFIC, Alagille syndrome-ALGS). In these||
2660|018|U|conditions, a substance that your body normally makes (bilirubin)||
2660|019|U|builds up in the liver and causes jaundice. Maralixibat belongs||
2660|020|U|to a class of drugs known as ileal bile acid transporter||
2660|021|U|inhibitors. It helps to lessen symptoms of jaundice such as||
2660|022|U|itching, yellowing eyes/skin, dark urine, and pale-colored||
2660|023|U|stools.||
2660|024|B|||
2660|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2660|026|H|from your pharmacist before you start using maralixibat and each||
2660|027|H|time you get a refill. If you have any questions, ask your doctor||
2660|028|H|or pharmacist.||
2660|029|H|   Take this medication by mouth 30 minutes before a meal as||
2660|030|H|directed by your doctor, usually either once daily (in the||
2660|031|H|morning) or twice daily (once in the morning and once in the||
2660|032|H|evening). The dosage is based on your medical condition, weight,||
2660|033|H|and response to treatment.||
2660|034|H|   To reduce your risk of side effects, your doctor may direct||
2660|035|H|you to start this medication at a low dose and gradually increase||
2660|036|H|your dose. Follow your doctor's instructions carefully.||
2660|037|H|   Use this medication regularly to get the most benefit from it.||
2660|038|H|To help you remember, take it at the same time(s) each day.||
2660|039|H|   Do not increase your dose or use this drug more often or for||
2660|040|H|longer than prescribed. Your condition will not improve any||
2660|041|H|faster, and your risk of side effects will increase.||
2660|042|H|   If you are also taking bile acid-binding resins such as||
2660|043|H|cholestyramine, colesevelam, or colestipol, take this medication||
2660|044|H|at least 4 hours before or at least 4 hours after taking these||
2660|045|H|medications. These medications can bind to maralixibat,||
2660|046|H|preventing your body from fully absorbing the drug.||
2660|047|H|   Tell your doctor if your condition does not get better or if||
2660|048|H|it gets worse.||
2660|049|B|||
2660|050|S|SIDE EFFECTS:  Diarrhea, vomiting, or abdominal pain may occur.||
2660|051|S|If any of these effects last or get worse, tell your doctor or||
2660|052|S|pharmacist promptly.||
2660|053|S|   Remember that this medication has been prescribed because your||
2660|054|S|doctor has judged that the benefit to you is greater than the||
2660|055|S|risk of side effects. Many people using this medication do not||
2660|056|S|have serious side effects.||
2660|057|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
2660|058|S|Contact your doctor promptly if you notice any symptoms of||
2660|059|S|dehydration, such as unusual decreased urination, unusual dry||
2660|060|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness.||
2660|061|S|   This medication may lower your fat-soluble vitamin levels, and||
2660|062|S|that may increase your risk for bone fractures and bleeding. Talk||
2660|063|S|to your doctor for more details.||
2660|064|S|   Although this medication is used to treat liver problems, it||
2660|065|S|may sometimes cause liver tests to worsen. Tell your doctor right||
2660|066|S|away if you have symptoms of worsening liver problems such as||
2660|067|S|nausea/vomiting that doesn't stop, loss of appetite, yellowing||
2660|068|S|eyes/skin, or dark urine.||
2660|069|S|   Tell your doctor right away if you have any serious side||
2660|070|S|effects, including: abdominal pain that won't go away,||
2660|071|S|blood/mucus in stools, fever.||
2660|072|S|   A very serious allergic reaction to this drug is rare.||
2660|073|S|However, get medical help right away if you notice any symptoms||
2660|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2660|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2660|076|S|breathing.||
2660|077|S|   This is not a complete list of possible side effects. If you||
2660|078|S|notice other effects not listed above, contact your doctor or||
2660|079|S|pharmacist.||
2660|080|S|   In the US -||
2660|081|S|   Call your doctor for medical advice about side effects. You||
2660|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2660|083|S|www.fda.gov/medwatch.||
2660|084|S|   In Canada - Call your doctor for medical advice about side||
2660|085|S|effects. You may report side effects to Health Canada at||
2660|086|S|1-866-234-2345.||
2660|087|B|||
2660|088|P|PRECAUTIONS:  Before taking maralixibat, tell your doctor or||
2660|089|P|pharmacist if you are allergic to it; or if you have any other||
2660|090|P|allergies. This product may contain inactive ingredients, which||
2660|091|P|can cause allergic reactions or other problems. Talk to your||
2660|092|P|pharmacist for more details.||
2660|093|P|   Before using this medication, tell your doctor or pharmacist||
2660|094|P|your medical history, especially of: other liver problems (such||
2660|095|P|as ascites, encephalopathy).||
2660|096|P|   Before having surgery, tell your doctor or dentist about all||
2660|097|P|the products you use (including prescription drugs,||
2660|098|P|nonprescription drugs, and herbal products).||
2660|099|P|   During pregnancy, this medication should be used only when||
2660|100|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
2660|101|P|benefits with your doctor.||
2660|102|P|   It is unknown if this medication passes into breast milk.||
2660|103|P|Consult your doctor before breastfeeding.||
2660|104|B|||
2660|105|I|DRUG INTERACTIONS:  See also How to Use section.||
2660|106|I|   Drug interactions may change how your medications work or||
2660|107|I|increase your risk for serious side effects. This document does||
2660|108|I|not contain all possible drug interactions. Keep a list of all||
2660|109|I|the products you use (including prescription/nonprescription||
2660|110|I|drugs and herbal products) and share it with your doctor and||
2660|111|I|pharmacist. Do not start, stop, or change the dosage of any||
2660|112|I|medicines without your doctor's approval.||
2660|113|B|||
2660|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2660|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2660|116|O|poison control center right away. US residents can call||
2660|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2660|118|B|||
2660|119|N|NOTES:  Do not share this medication with others.||
2660|120|N|   Lab and/or medical tests (such as liver function, fat-soluble||
2660|121|N|vitamin levels) should be done before starting this medication||
2660|122|N|and while you are taking it. Keep all medical and lab||
2660|123|N|appointments.||
2660|124|B|||
2660|125|D|MISSED DOSE:  If you are taking this medication once daily and||
2660|126|D|you miss a dose, take it as soon as you remember. If it is more||
2660|127|D|than 12 hours after the missed dose, skip the missed dose. Take||
2660|128|D|your next dose at the regular time. Do not double the dose to||
2660|129|D|catch up.||
2660|130|D|   If you are taking this medication twice daily and you miss a||
2660|131|D|dose, take it as soon as you remember. If it is more than 6 hours||
2660|132|D|after the missed dose, skip the missed dose. Take your next dose||
2660|133|D|at the regular time. Do not double the dose to catch up.||
2660|134|B|||
2660|135|R|STORAGE:  Store at room temperature away from light and moisture.||
2660|136|R|Do not store in the bathroom. Keep all medications away from||
2660|137|R|children and pets.||
2660|138|R|   Do not flush medications down the toilet or pour them into a||
2660|139|R|drain unless instructed to do so. Properly discard this product||
2660|140|R|when it is expired or no longer needed. Consult your pharmacist||
2660|141|R|or local waste disposal company.||
2660|142|B|||
2660|143|A|Information last revised May 2025.||
2660|144|A|Copyright(c) 2025 First Databank, Inc.||
2660|145|B|||
2661|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2661|002|Z|does NOT have all possible information about this product. This||
2661|003|Z|information does not assure that this product is safe, effective,||
2661|004|Z|or appropriate for you. This information is not individual||
2661|005|Z|medical advice and does not substitute for the advice of your||
2661|006|Z|health care professional. Always ask your health care||
2661|007|Z|professional for complete information about this product and your||
2661|008|Z|specific health needs.||
2661|009|B|||
2661|010|T|EFBEMALENOGRASTIM ALFA - INJECTION||
2661|011|B|||
2661|012|C|COMMON BRAND NAME(S): Ryzneuta||
2661|013|B|||
2661|014|U|USES:  Efbemalenograstim alfa is a human-made version of a||
2661|015|U|certain natural substance made by your body. It is used to help||
2661|016|U|your body make more white blood cells. White blood cells are||
2661|017|U|important to help you fight off infections. Efbemalenograstim||
2661|018|U|alfa is given to people whose ability to make white blood cells||
2661|019|U|is reduced due to chemotherapy.||
2661|020|B|||
2661|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2661|022|H|from your pharmacist before you start using efbemalenograstim||
2661|023|H|alfa and each time you get a treatment. If you have any||
2661|024|H|questions, ask your doctor or pharmacist.||
2661|025|H|   This medication is given by injection under the skin by a||
2661|026|H|health care professional. It is given as directed by your doctor,||
2661|027|H|usually once during each chemotherapy cycle. However, it should||
2661|028|H|not be given within 14 days before or less than 24 hours after||
2661|029|H|chemotherapy.||
2661|030|B|||
2661|031|S|SIDE EFFECTS:  Nausea may occur. If this effect lasts or gets||
2661|032|S|worse, tell your doctor or pharmacist promptly.||
2661|033|S|   Remember that this medication has been prescribed because your||
2661|034|S|doctor has judged that the benefit to you is greater than the||
2661|035|S|risk of side effects. Many people using this medication do not||
2661|036|S|have serious side effects.||
2661|037|S|   Tell your doctor right away if you have any serious side||
2661|038|S|effects, including: pink/bloody urine, easy bleeding/bruising,||
2661|039|S|fever, fast heartbeat, purple/red spots on your skin, back pain.||
2661|040|S|   Get medical help right away if you have any very serious side||
2661|041|S|effects, including: breathing problems (such as shortness of||
2661|042|S|breath, fast breathing), unusual decrease in urination, unusual||
2661|043|S|tiredness, swelling/puffiness of the body.||
2661|044|S|   Rarely, serious (possibly fatal) damage to the spleen may||
2661|045|S|occur. Get medical help right away if you develop||
2661|046|S|stomach/abdominal pain or shoulder pain.||
2661|047|S|   Rarely, this medication may increase the risk of developing a||
2661|048|S|certain bone marrow disorder (myelodysplastic syndrome-MDS) or||
2661|049|S|blood cancer (acute myeloid leukemia-AML) in people with breast||
2661|050|S|or lung cancer who are receiving chemotherapy/radiation. Ask your||
2661|051|S|doctor for more details.||
2661|052|S|   A very serious allergic reaction to this drug is rare.||
2661|053|S|However, get medical help right away if you notice any symptoms||
2661|054|S|of a serious allergic reaction, including: rash, itching/swelling||
2661|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2661|056|S|breathing.||
2661|057|S|   This is not a complete list of possible side effects. If you||
2661|058|S|notice other effects not listed above, contact your doctor or||
2661|059|S|pharmacist.||
2661|060|S|   In the US -||
2661|061|S|   Call your doctor for medical advice about side effects. You||
2661|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2661|063|S|www.fda.gov/medwatch.||
2661|064|S|   In Canada - Call your doctor for medical advice about side||
2661|065|S|effects. You may report side effects to Health Canada at||
2661|066|S|1-866-234-2345.||
2661|067|B|||
2661|068|P|PRECAUTIONS:  Before using efbemalenograstim alfa, tell your||
2661|069|P|doctor or pharmacist if you are allergic to it; or to||
2661|070|P|pegfilgrastim or filgrastim products; or if you have any other||
2661|071|P|allergies. This product may contain inactive ingredients (such as||
2661|072|P|latex found in the needle cap of the prefilled syringe), which||
2661|073|P|can cause allergic reactions or other problems. Talk to your||
2661|074|P|pharmacist for more details.||
2661|075|P|   Before using this medication, tell your doctor or pharmacist||
2661|076|P|your medical history, especially of: sickle cell disease, spleen||
2661|077|P|problems.||
2661|078|P|   Before having surgery, tell your doctor or dentist about all||
2661|079|P|the products you use (including prescription drugs,||
2661|080|P|nonprescription drugs, and herbal products).||
2661|081|P|   During pregnancy, this medication should be used only when||
2661|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
2661|083|P|   It is unknown if this medication passes into breast milk.||
2661|084|P|Consult your doctor before breastfeeding.||
2661|085|B|||
2661|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2661|087|I|medications work or increase your risk for serious side effects.||
2661|088|I|This document does not contain all possible drug interactions.||
2661|089|I|Keep a list of all the products you use (including||
2661|090|I|prescription/nonprescription drugs and herbal products) and share||
2661|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2661|092|I|the dosage of any medicines without your doctor's approval.||
2661|093|I|   This medication may interfere with certain lab tests (such as||
2661|094|I|bone imaging tests), possibly causing false test results. Make||
2661|095|I|sure lab personnel and all your doctors know you use this drug.||
2661|096|B|||
2661|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2661|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2661|099|O|poison control center right away. US residents can call||
2661|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2661|101|B|||
2661|102|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2661|103|N|kidney function) should be done while you are using this||
2661|104|N|medication. Keep all medical and lab appointments. Consult your||
2661|105|N|doctor for more details.||
2661|106|B|||
2661|107|D|MISSED DOSE:  It is important to get each dose of this medication||
2661|108|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2661|109|D|right away for a new dosing schedule.||
2661|110|B|||
2661|111|R|STORAGE:  Not applicable. This medication is given in a hospital||
2661|112|R|or clinic and will not be stored at home.||
2661|113|B|||
2661|114|A|Information last revised May 2025.||
2661|115|A|Copyright(c) 2025 First Databank, Inc.||
2661|116|B|||
2662|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2662|002|Z|does NOT have all possible information about this product. This||
2662|003|Z|information does not assure that this product is safe, effective,||
2662|004|Z|or appropriate for you. This information is not individual||
2662|005|Z|medical advice and does not substitute for the advice of your||
2662|006|Z|health care professional. Always ask your health care||
2662|007|Z|professional for complete information about this product and your||
2662|008|Z|specific health needs.||
2662|009|B|||
2662|010|T|TELISOTUZUMAB VEDOTIN - INJECTION||
2662|011|F|(tel-EYE-soe-TOOZ-ue-mab ve-DOE-tin)||
2662|012|B|||
2662|013|C|COMMON BRAND NAME(S): Emrelis||
2662|014|B|||
2662|015|U|USES:  This medication is used to treat a certain type of lung||
2662|016|U|cancer (non-squamous non-small cell lung cancer-NSCLC). It works||
2662|017|U|by slowing or stopping the growth of cancer cells.||
2662|018|B|||
2662|019|H|HOW TO USE:  Read the Medication Guide provided by your||
2662|020|H|pharmacist before you start receiving telisotuzumab vedotin and||
2662|021|H|each time you get an injection. If you have any questions, ask||
2662|022|H|your doctor or pharmacist.||
2662|023|H|   This medication is given by injection into a vein by a health||
2662|024|H|care professional over 30 minutes. It is given as directed by||
2662|025|H|your doctor, usually once every 2 weeks.||
2662|026|H|   The dosage is based on your medical condition, weight, and||
2662|027|H|response to treatment.||
2662|028|H|   Infusion reactions may happen during the infusion of this||
2662|029|H|drug. Your doctor may prescribe other medications (such as||
2662|030|H|acetaminophen, diphenhydramine, methylprednisolone) before each||
2662|031|H|treatment to help prevent these side effects. Tell your doctor||
2662|032|H|right away if you have any symptoms of infusion reactions such as||
2662|033|H|fever, chills, flushing, nausea, or low blood pressure. Your||
2662|034|H|doctor may give you other medications to help with these side||
2662|035|H|effects or may slow down or stop your treatment for some time.||
2662|036|H|   Use this medication regularly to get the most benefit from it.||
2662|037|H|To help you remember, mark your calendar with a reminder.||
2662|038|B|||
2662|039|S|SIDE EFFECTS:  See also How to Use section.||
2662|040|S|   Tiredness, loss of appetite, or swelling of the||
2662|041|S|ankles/feet/hands may occur. If any of these effects last or get||
2662|042|S|worse, tell your doctor or pharmacist promptly.||
2662|043|S|   People using this medication may have serious side effects.||
2662|044|S|However, you have been prescribed this drug because your doctor||
2662|045|S|has judged that the benefit to you is greater than the risk of||
2662|046|S|side effects. Careful monitoring by your doctor may decrease your||
2662|047|S|risk.||
2662|048|S|   Tell your doctor right away if you have any serious side||
2662|049|S|effects, including: numbness/tingling/weakness/pain of the||
2662|050|S|hands/feet/arms/legs, eye pain/redness/swelling, dry eyes,||
2662|051|S|changes in vision (such as blurred vision, sensitivity to light).||
2662|052|S|   Get medical help right away if you have any very serious side||
2662|053|S|effects, including: new or worsening signs of lung problems (such||
2662|054|S|as cough that doesn't go away, chest pain, shortness of breath).||
2662|055|S|   A very serious allergic reaction to this drug is rare.||
2662|056|S|However, get medical help right away if you notice any symptoms||
2662|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2662|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2662|059|S|breathing.||
2662|060|S|   This is not a complete list of possible side effects. If you||
2662|061|S|notice other effects not listed above, contact your doctor or||
2662|062|S|pharmacist.||
2662|063|S|   In the US -||
2662|064|S|   Call your doctor for medical advice about side effects. You||
2662|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2662|066|S|www.fda.gov/medwatch.||
2662|067|S|   In Canada - Call your doctor for medical advice about side||
2662|068|S|effects. You may report side effects to Health Canada at||
2662|069|S|1-866-234-2345.||
2662|070|B|||
2662|071|P|PRECAUTIONS:  Before receiving telisotuzumab vedotin, tell your||
2662|072|P|doctor or pharmacist if you are allergic to it; or if you have||
2662|073|P|any other allergies. This product may contain inactive||
2662|074|P|ingredients, which can cause allergic reactions or other||
2662|075|P|problems. Talk to your pharmacist for more details.||
2662|076|P|   Before using this medication, tell your doctor or pharmacist||
2662|077|P|your medical history, especially of: liver disease, eye problems,||
2662|078|P|nerve problems (such as numbness/tingling).||
2662|079|P|   This drug may cause blurred vision. Do not drive, use||
2662|080|P|machinery, or do anything that needs alertness or clear vision||
2662|081|P|until you can do it safely. Limit alcoholic beverages. Talk to||
2662|082|P|your doctor if you are using marijuana (cannabis).||
2662|083|P|   Before having surgery, tell your doctor or dentist about all||
2662|084|P|the products you use (including prescription drugs,||
2662|085|P|nonprescription drugs, and herbal products).||
2662|086|P|   Tell your doctor if you are pregnant or plan to become||
2662|087|P|pregnant. You should not become pregnant while using||
2662|088|P|telisotuzumab vedotin. Telisotuzumab vedotin may harm an unborn||
2662|089|P|baby. Your doctor should order a pregnancy test before you start||
2662|090|P|this medication. Women using this medication should ask about||
2662|091|P|reliable forms of birth control during treatment and for 2 months||
2662|092|P|after the last dose. Men using this medication should ask about||
2662|093|P|reliable forms of birth control during treatment and for 4 months||
2662|094|P|after the last dose. If you or your partner becomes pregnant,||
2662|095|P|talk to your doctor right away about the risks and benefits of||
2662|096|P|this medication.||
2662|097|P|   It is unknown if this drug passes into breast milk. Because of||
2662|098|P|the possible risk to the infant, breastfeeding is not recommended||
2662|099|P|while using this drug and for at least 1 month after the last||
2662|100|P|dose. Consult your doctor before breastfeeding.||
2662|101|B|||
2662|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2662|103|I|medications work or increase your risk for serious side effects.||
2662|104|I|This document does not contain all possible drug interactions.||
2662|105|I|Keep a list of all the products you use (including||
2662|106|I|prescription/nonprescription drugs and herbal products) and share||
2662|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
2662|108|I|the dosage of any medicines without your doctor's approval.||
2662|109|B|||
2662|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2662|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2662|112|O|poison control center right away. US residents can call||
2662|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2662|114|B|||
2662|115|N|NOTES:  Lab and/or medical tests (such as blood sugar, complete||
2662|116|N|blood counts, eye exams, liver function) may be done while you||
2662|117|N|are using this medication. Keep all medical and lab appointments.||
2662|118|B|||
2662|119|D|MISSED DOSE:  It is important to get each dose of this medication||
2662|120|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2662|121|D|right away for a new dosing schedule.||
2662|122|B|||
2662|123|R|STORAGE:  Not applicable. This medication is given in a hospital||
2662|124|R|or clinic or doctor's office and will not be stored at home.||
2662|125|B|||
2662|126|M|MEDICAL ALERT:  Your condition can cause complications in a||
2662|127|M|medical emergency. For information about enrolling in MedicAlert,||
2662|128|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2662|129|B|||
2662|130|A|Information last revised May 2025.||
2662|131|A|Copyright(c) 2025 First Databank, Inc.||
2662|132|B|||
2663|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2663|002|Z|does NOT have all possible information about this product. This||
2663|003|Z|information does not assure that this product is safe, effective,||
2663|004|Z|or appropriate for you. This information is not individual||
2663|005|Z|medical advice and does not substitute for the advice of your||
2663|006|Z|health care professional. Always ask your health care||
2663|007|Z|professional for complete information about this product and your||
2663|008|Z|specific health needs.||
2663|009|B|||
2663|010|T|TREPROSTINIL POWDER IN CAPSULE - ORAL INHALATION||
2663|011|F|(tre-PROS-ti-nil)||
2663|012|B|||
2663|013|C|COMMON BRAND NAME(S): Yutrepia||
2663|014|B|||
2663|015|U|USES:  This medication is used to treat a type of high blood||
2663|016|U|pressure in the lungs (pulmonary arterial hypertension).||
2663|017|U|Treprostinil helps to increase your ability to exercise and||
2663|018|U|improves symptoms such as shortness of breath and tiredness. It||
2663|019|U|works by relaxing and widening the blood vessels (arteries) in||
2663|020|U|the lungs and other parts of the body so that blood can flow more||
2663|021|U|easily. This medication belongs to a class of drugs known as||
2663|022|U|vasodilators.||
2663|023|B|||
2663|024|H|HOW TO USE:  Read the Instructions for Use provided by your||
2663|025|H|pharmacist before you start using this medication and each time||
2663|026|H|you get a refill. Follow the illustrated directions for the||
2663|027|H|proper use of this medication. If you have any questions, ask||
2663|028|H|your doctor or pharmacist.||
2663|029|H|   Do not swallow these capsules. Use the special inhaler device||
2663|030|H|to inhale the powder in the capsules. Inhale this medication by||
2663|031|H|mouth as directed by your doctor, usually 4 times daily.||
2663|032|H|   Wash and completely dry hands before touching the capsules.||
2663|033|H|Leave the capsules sealed in the blister card until just before||
2663|034|H|use. Each capsule should be used within 5 minutes once removed||
2663|035|H|from the blister card. Load 1 capsule in the inhaler and be sure||
2663|036|H|to inhale quickly and deeply through the mouthpiece. Inhale the||
2663|037|H|capsule contents as directed to make sure you inhale all of the||
2663|038|H|drug. You should hear and feel the capsule "whirl" (spin) as you||
2663|039|H|breathe in. Take the inhaler out of your mouth and hold your||
2663|040|H|breath for 5 seconds, then breathe out. Do not breathe out into||
2663|041|H|the mouthpiece at anytime. Inhale 2 times per capsule to make||
2663|042|H|sure you inhale all of the drug. Remove the used capsule from the||
2663|043|H|inhaler. If your dose is for more than 1 capsule, repeat with||
2663|044|H|another capsule and continue until you get the full dose. Take||
2663|045|H|used capsules out of the inhaler before storing the inhaler. Do||
2663|046|H|not store unused capsules in the inhaler for a future dose.||
2663|047|H|   The dosage is based on your medical condition and response to||
2663|048|H|treatment.||
2663|049|H|   To reduce your risk of side effects, your doctor may direct||
2663|050|H|you to start this medication at a low dose and gradually increase||
2663|051|H|your dose. Follow your doctor's instructions carefully.||
2663|052|H|   Use this medication regularly to get the most benefit from it.||
2663|053|H|To help you remember, use it at the same times each day.||
2663|054|H|   Do not increase your dose or use this drug more often or for||
2663|055|H|longer than prescribed. Your condition will not improve any||
2663|056|H|faster, and your risk of side effects will increase.||
2663|057|H|   Tell your doctor if your condition does not get better or if||
2663|058|H|it gets worse.||
2663|059|B|||
2663|060|S|SIDE EFFECTS:  Cough, headache, nausea, dizziness, or||
2663|061|S|lightheadedness may occur. If any of these effects last or get||
2663|062|S|worse, tell your doctor or pharmacist promptly.||
2663|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
2663|064|S|slowly when rising from a sitting or lying position.||
2663|065|S|   Remember that this medication has been prescribed because your||
2663|066|S|doctor has judged that the benefit to you is greater than the||
2663|067|S|risk of side effects. Many people using this medication do not||
2663|068|S|have serious side effects.||
2663|069|S|   Tell your doctor right away if you have any serious side||
2663|070|S|effects, including: unusual bleeding/bruising.||
2663|071|S|   A very serious allergic reaction to this drug is rare.||
2663|072|S|However, get medical help right away if you notice any symptoms||
2663|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2663|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2663|075|S|breathing.||
2663|076|S|   This is not a complete list of possible side effects. If you||
2663|077|S|notice other effects not listed above, contact your doctor or||
2663|078|S|pharmacist.||
2663|079|S|   In the US -||
2663|080|S|   Call your doctor for medical advice about side effects. You||
2663|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2663|082|S|www.fda.gov/medwatch.||
2663|083|S|   In Canada - Call your doctor for medical advice about side||
2663|084|S|effects. You may report side effects to Health Canada at||
2663|085|S|1-866-234-2345.||
2663|086|B|||
2663|087|P|PRECAUTIONS:  Before using treprostinil, tell your doctor or||
2663|088|P|pharmacist if you are allergic to it; or if you have any other||
2663|089|P|allergies. This product may contain inactive ingredients, which||
2663|090|P|can cause allergic reactions or other problems. Talk to your||
2663|091|P|pharmacist for more details.||
2663|092|P|   Before using this medication, tell your doctor or pharmacist||
2663|093|P|your medical history, especially of: low blood pressure, liver||
2663|094|P|problems, bleeding problems, other breathing problems (such as||
2663|095|P|asthma, chronic obstructive pulmonary disease-COPD).||
2663|096|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2663|097|P|can make you more dizzy. Do not drive, use machinery, or do||
2663|098|P|anything that needs alertness until you can do it safely. Limit||
2663|099|P|alcoholic beverages. Talk to your doctor if you are using||
2663|100|P|marijuana (cannabis).||
2663|101|P|   Before having surgery, tell your doctor or dentist about all||
2663|102|P|the products you use (including prescription drugs,||
2663|103|P|nonprescription drugs, and herbal products).||
2663|104|P|   During pregnancy, this medication should be used only when||
2663|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
2663|106|P|   This medication passes into breast milk. Consult your doctor||
2663|107|P|before breastfeeding.||
2663|108|B|||
2663|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2663|110|I|medications work or increase your risk for serious side effects.||
2663|111|I|This document does not contain all possible drug interactions.||
2663|112|I|Keep a list of all the products you use (including||
2663|113|I|prescription/nonprescription drugs and herbal products) and share||
2663|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
2663|115|I|the dosage of any medicines without your doctor's approval.||
2663|116|B|||
2663|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2663|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2663|119|O|poison control center right away. US residents can call||
2663|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2663|121|O|Symptoms of overdose may include: severe dizziness, fainting.||
2663|122|B|||
2663|123|N|NOTES:  Do not share this medication with others.||
2663|124|N|   Lab and/or medical tests (such as blood pressure) may be done||
2663|125|N|while you are using this medication. Keep all medical and lab||
2663|126|N|appointments. Consult your doctor for more details.||
2663|127|B|||
2663|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2663|129|D|If it is near the time of the next dose, skip the missed dose.||
2663|130|D|Use your next dose at the regular time. Do not double the dose to||
2663|131|D|catch up.||
2663|132|B|||
2663|133|R|STORAGE:  Store the capsules at room temperature away from light||
2663|134|R|and moisture. Keep the capsules in the original blister pack||
2663|135|R|until ready to use. Do not store in the bathroom.||
2663|136|R|   Keep the inhaler device dry. Discard the inhaler device after||
2663|137|R|7 days of use or 56 capsules, whichever comes first. Keep all||
2663|138|R|medications away from children and pets.||
2663|139|R|   Do not flush medications down the toilet or pour them into a||
2663|140|R|drain unless instructed to do so. Properly discard this product||
2663|141|R|when it is expired or no longer needed. Consult your pharmacist||
2663|142|R|or local waste disposal company.||
2663|143|B|||
2663|144|A|Information last revised August 2025.||
2663|145|A|Copyright(c) 2025 First Databank, Inc.||
2663|146|B|||
2664|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2664|002|Z|does NOT have all possible information about this product. This||
2664|003|Z|information does not assure that this product is safe, effective,||
2664|004|Z|or appropriate for you. This information is not individual||
2664|005|Z|medical advice and does not substitute for the advice of your||
2664|006|Z|health care professional. Always ask your health care||
2664|007|Z|professional for complete information about this product and your||
2664|008|Z|specific health needs.||
2664|009|B|||
2664|010|T|ENSARTINIB - ORAL||
2664|011|F|(en-SAR-ti-nib)||
2664|012|B|||
2664|013|C|COMMON BRAND NAME(S): Ensacove||
2664|014|B|||
2664|015|U|USES:  Ensartinib is used to treat a certain type of lung cancer.||
2664|016|U|Ensartinib belongs to a class of drugs known as kinase||
2664|017|U|inhibitors. It works by slowing or stopping the growth of cancer||
2664|018|U|cells.||
2664|019|B|||
2664|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2664|021|H|from your pharmacist before you start taking ensartinib and each||
2664|022|H|time you get a refill. If you have any questions, ask your doctor||
2664|023|H|or pharmacist.||
2664|024|H|   Take this medication by mouth with or without food as directed||
2664|025|H|by your doctor, usually once daily. Swallow the capsules whole.||
2664|026|H|Do not crush or chew the capsules. Do not open or dissolve the||
2664|027|H|contents of the capsules.||
2664|028|H|   The dosage is based on your medical condition and response to||
2664|029|H|treatment.||
2664|030|H|   Use this medication regularly to get the most benefit from it.||
2664|031|H|To help you remember, take it at the same time each day.||
2664|032|H|   Do not increase your dose or take this drug more often or for||
2664|033|H|longer than prescribed. Your condition will not improve any||
2664|034|H|faster, and your risk of serious side effects will increase.||
2664|035|H|   If you vomit after taking a dose, do not take an extra dose.||
2664|036|H|Take your next dose at the regular time.||
2664|037|H|   Since this drug can be absorbed through the skin and lungs and||
2664|038|H|may harm an unborn baby, women who are pregnant or who may become||
2664|039|H|pregnant should not handle this medication or breathe the dust||
2664|040|H|from the capsules.||
2664|041|B|||
2664|042|S|SIDE EFFECTS:  Tiredness, constipation, nausea, vomiting,||
2664|043|S|swelling ankles/feet/hands, or dizziness may occur. If any of||
2664|044|S|these effects last or get worse, tell your doctor or pharmacist||
2664|045|S|promptly.||
2664|046|S|   Remember that this medication has been prescribed because your||
2664|047|S|doctor has judged that the benefit to you is greater than the||
2664|048|S|risk of side effects. Many people using this medication do not||
2664|049|S|have serious side effects.||
2664|050|S|   Tell your doctor right away if you have any serious side||
2664|051|S|effects, including: signs of liver problems (such as||
2664|052|S|nausea/vomiting that doesn't stop, loss of appetite,||
2664|053|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), slow||
2664|054|S|heartbeat, vision changes (such as double/blurred vision,||
2664|055|S|decreased vision), muscle pain/tenderness/weakness, signs of high||
2664|056|S|uric acid level in the blood (such as toe/joint pain, painful||
2664|057|S|urination, change in the amount of urine).||
2664|058|S|   This medication may make your blood sugar rise, which can||
2664|059|S|cause or worsen diabetes. Tell your doctor right away if you have||
2664|060|S|symptoms of high blood sugar, such as increased thirst/urination.||
2664|061|S|If you already have diabetes, check your blood sugar regularly as||
2664|062|S|directed and share the results with your doctor. Your doctor may||
2664|063|S|need to adjust your diabetes medication, exercise program, or||
2664|064|S|diet.||
2664|065|S|   Get medical help right away if you have any very serious side||
2664|066|S|effects, including: new/worsening lung disease (such as shortness||
2664|067|S|of breath, cough, fever, chest pain).||
2664|068|S|   Ensartinib can commonly cause a rash that is usually not||
2664|069|S|serious. However, you may not be able to tell it apart from a||
2664|070|S|rare rash that could be a sign of a severe reaction. Tell your||
2664|071|S|doctor right away if you develop any rash.||
2664|072|S|   A very serious allergic reaction to this drug is rare.||
2664|073|S|However, get medical help right away if you notice any symptoms||
2664|074|S|of a serious allergic reaction, including: fever, swollen lymph||
2664|075|S|nodes, rash, itching/swelling (especially of the||
2664|076|S|face/tongue/throat), severe dizziness, trouble breathing.||
2664|077|S|   This is not a complete list of possible side effects. If you||
2664|078|S|notice other effects not listed above, contact your doctor or||
2664|079|S|pharmacist.||
2664|080|S|   In the US -||
2664|081|S|   Call your doctor for medical advice about side effects. You||
2664|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2664|083|S|www.fda.gov/medwatch.||
2664|084|S|   In Canada - Call your doctor for medical advice about side||
2664|085|S|effects. You may report side effects to Health Canada at||
2664|086|S|1-866-234-2345.||
2664|087|B|||
2664|088|P|PRECAUTIONS:  Before taking ensartinib, tell your doctor or||
2664|089|P|pharmacist if you are allergic to it or if you have any other||
2664|090|P|allergies. This product may contain inactive ingredients (such as||
2664|091|P|tartrazine), which can cause allergic reactions or other||
2664|092|P|problems. Talk to your pharmacist for more details.||
2664|093|P|   Before using this medication, tell your doctor or pharmacist||
2664|094|P|your medical history, especially of: liver disease, diabetes,||
2664|095|P|slow heartbeat.||
2664|096|P|   This drug may make you dizzy or cause vision changes. Alcohol||
2664|097|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
2664|098|P|use machinery, or do anything that needs alertness or clear||
2664|099|P|vision until you can do it safely. Limit alcoholic beverages.||
2664|100|P|Talk to your doctor if you are using marijuana (cannabis).||
2664|101|P|   This medication may make you more sensitive to the sun. Limit||
2664|102|P|your time in the sun during treatment and for at least 1 week||
2664|103|P|after the last dose. Avoid tanning booths and sunlamps. Use||
2664|104|P|sunscreen and wear protective clothing when outdoors. Tell your||
2664|105|P|doctor right away if you get sunburned or have skin||
2664|106|P|blisters/redness.||
2664|107|P|   Before having surgery, tell your doctor or dentist about all||
2664|108|P|the products you use (including prescription drugs,||
2664|109|P|nonprescription drugs, and herbal products).||
2664|110|P|   Since this drug can be absorbed through the skin and lungs and||
2664|111|P|may harm an unborn baby, women who are pregnant or who may become||
2664|112|P|pregnant should not handle this medication or breathe the dust||
2664|113|P|from the capsules.||
2664|114|P|   Tell your doctor if you are pregnant or plan to become||
2664|115|P|pregnant. You should not become pregnant while using ensartinib.||
2664|116|P|Ensartinib may harm an unborn baby. Your doctor should order a||
2664|117|P|pregnancy test before you start this medication. Men and women||
2664|118|P|using this medication should ask about reliable forms of birth||
2664|119|P|control during treatment and for 1 week after the last dose. If||
2664|120|P|you or your partner becomes pregnant, talk to your doctor right||
2664|121|P|away about the risks and benefits of this medication.||
2664|122|P|   It is unknown if this medication passes into breast milk.||
2664|123|P|Because of the possible risk to the infant, breastfeeding is not||
2664|124|P|recommended while using this medication and for 1 week after the||
2664|125|P|last dose. Consult your doctor before breastfeeding.||
2664|126|B|||
2664|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2664|128|I|medications work or increase your risk for serious side effects.||
2664|129|I|This document does not contain all possible drug interactions.||
2664|130|I|Keep a list of all the products you use (including||
2664|131|I|prescription/nonprescription drugs and herbal products) and share||
2664|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
2664|133|I|the dosage of any medicines without your doctor's approval.||
2664|134|B|||
2664|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2664|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2664|137|O|poison control center right away. US residents can call||
2664|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2664|139|B|||
2664|140|N|NOTES:  Do not share this medication with others.||
2664|141|N|   Lab and/or medical tests (such as liver function, eye exams,||
2664|142|N|heart rate, blood sugar, CPK levels, uric acid levels) should be||
2664|143|N|done before you start taking this medication and while you are||
2664|144|N|taking it. Keep all medical and lab appointments.||
2664|145|B|||
2664|146|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2664|147|D|remember. If it is within 12 hours of the next dose, skip the||
2664|148|D|missed dose. Take your next dose at the regular time. Do not||
2664|149|D|double the dose to catch up.||
2664|150|B|||
2664|151|R|STORAGE:  Store in the original bottle at room temperature away||
2664|152|R|from light and moisture. Do not store in the bathroom. Keep the||
2664|153|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
2664|154|R|when not in use. Keep all medications away from children and||
2664|155|R|pets.||
2664|156|R|   Do not flush medications down the toilet or pour them into a||
2664|157|R|drain unless instructed to do so. Properly discard this product||
2664|158|R|when it is expired or no longer needed. Consult your pharmacist||
2664|159|R|or local waste disposal company.||
2664|160|B|||
2664|161|A|Information last revised June 2025.||
2664|162|A|Copyright(c) 2025 First Databank, Inc.||
2664|163|B|||
2665|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2665|002|Z|does NOT have all possible information about this product. This||
2665|003|Z|information does not assure that this product is safe, effective,||
2665|004|Z|or appropriate for you. This information is not individual||
2665|005|Z|medical advice and does not substitute for the advice of your||
2665|006|Z|health care professional. Always ask your health care||
2665|007|Z|professional for complete information about this product and your||
2665|008|Z|specific health needs.||
2665|009|B|||
2665|010|T|AZTREONAM/AVIBACTAM - INJECTION||
2665|011|F|(az-TREE-oh-nam/A-vi-BAK-tam)||
2665|012|B|||
2665|013|C|COMMON BRAND NAME(S): Emblaveo||
2665|014|B|||
2665|015|U|USES:  This medication is used along with another antibiotic to||
2665|016|U|treat certain bacterial infections. This product contains 2||
2665|017|U|different medications: aztreonam and avibactam. Aztreonam is an||
2665|018|U|antibiotic that works by stopping the growth of bacteria.||
2665|019|U|Avibactam is an enzyme inhibitor (beta-lactamase inhibitor) that||
2665|020|U|helps aztreonam work better.||
2665|021|B|||
2665|022|H|HOW TO USE:  This medication is given by injection into a vein as||
2665|023|H|directed by your doctor, usually every 6 hours. It is injected||
2665|024|H|slowly into the vein over 3 hours. The dosage and length of||
2665|025|H|treatment are based on your medical condition and response to||
2665|026|H|treatment.||
2665|027|H|   If you are using this medication at home, learn all||
2665|028|H|preparation and usage instructions from your health care||
2665|029|H|professional. Before using, check this product for particles or||
2665|030|H|discoloration. If either is present, do not use the liquid. Learn||
2665|031|H|how to store and discard medical supplies safely.||
2665|032|H|   For the best effect, use this antibiotic at evenly spaced||
2665|033|H|times. To help you remember, use this medication at the same||
2665|034|H|times every day.||
2665|035|H|   Continue to use this medication until the full prescribed||
2665|036|H|amount is finished, even if symptoms disappear after a few days.||
2665|037|H|Stopping the medication too early may result in a return of the||
2665|038|H|infection.||
2665|039|H|   Tell your doctor if your condition lasts or gets worse.||
2665|040|B|||
2665|041|S|SIDE EFFECTS:  Diarrhea may occur. If this effect lasts or gets||
2665|042|S|worse, tell your doctor or pharmacist promptly.||
2665|043|S|   Remember that this medication has been prescribed because your||
2665|044|S|doctor has judged that the benefit to you is greater than the||
2665|045|S|risk of side effects. Many people using this medication do not||
2665|046|S|have serious side effects.||
2665|047|S|   Tell your doctor right away if you have any serious side||
2665|048|S|effects, including: signs of liver disease (such as||
2665|049|S|nausea/vomiting that doesn't stop, loss of appetite,||
2665|050|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2665|051|S|of anemia (such as unusual tiredness, pale skin, rapid||
2665|052|S|breathing), fast/irregular heartbeat, muscle cramps.||
2665|053|S|   This medication may rarely cause a severe intestinal condition||
2665|054|S|due to a bacteria called C. difficile. This condition may occur||
2665|055|S|during treatment or weeks to months after treatment has stopped.||
2665|056|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2665|057|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2665|058|S|stool.||
2665|059|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2665|060|S|products because they may make symptoms worse.||
2665|061|S|   This medication may sometimes cause oral thrush or a new yeast||
2665|062|S|infection. Contact your doctor if you notice white patches in||
2665|063|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2665|064|S|   A very serious allergic reaction to this drug is rare.||
2665|065|S|However, get medical help right away if you notice any symptoms||
2665|066|S|of a serious allergic reaction, including: rash, itching/swelling||
2665|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2665|068|S|breathing.||
2665|069|S|   This is not a complete list of possible side effects. If you||
2665|070|S|notice other effects not listed above, contact your doctor or||
2665|071|S|pharmacist.||
2665|072|S|   In the US -||
2665|073|S|   Call your doctor for medical advice about side effects. You||
2665|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2665|075|S|www.fda.gov/medwatch.||
2665|076|S|   In Canada - Call your doctor for medical advice about side||
2665|077|S|effects. You may report side effects to Health Canada at||
2665|078|S|1-866-234-2345.||
2665|079|B|||
2665|080|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2665|081|P|pharmacist if you are allergic to aztreonam or avibactam; or to||
2665|082|P|penicillins, beta-lactam antibiotics, or cephalosporins, or||
2665|083|P|certain other antibiotics (such as imipenem, meropenem); or to||
2665|084|P|other beta-lactamase inhibitors (such as sulbactam); or if you||
2665|085|P|have any other allergies. This product may contain inactive||
2665|086|P|ingredients, which can cause allergic reactions or other||
2665|087|P|problems. Talk to your pharmacist for more details.||
2665|088|P|   Before using this medication, tell your doctor or pharmacist||
2665|089|P|your medical history, especially of: kidney disease, liver||
2665|090|P|disease.||
2665|091|P|   Aztreonam/avibactam may cause live bacterial vaccines (such as||
2665|092|P|typhoid vaccine) to not work well. Tell your health care||
2665|093|P|professional that you are using aztreonam/avibactam before having||
2665|094|P|any immunizations/vaccinations.||
2665|095|P|   Before having surgery, tell your doctor or dentist about all||
2665|096|P|the products you use (including prescription drugs,||
2665|097|P|nonprescription drugs, and herbal products).||
2665|098|P|   During pregnancy, this medication should be used only when||
2665|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
2665|100|P|   Aztreonam passes into breast milk. It is unknown if avibactam||
2665|101|P|passes into breast milk. Consult your doctor before||
2665|102|P|breastfeeding.||
2665|103|B|||
2665|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2665|105|I|medications work or increase your risk for serious side effects.||
2665|106|I|This document does not contain all possible drug interactions.||
2665|107|I|Keep a list of all the products you use (including||
2665|108|I|prescription/nonprescription drugs and herbal products) and share||
2665|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
2665|110|I|the dosage of any medicines without your doctor's approval.||
2665|111|B|||
2665|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2665|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2665|114|O|poison control center right away. US residents can call||
2665|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2665|116|B|||
2665|117|N|NOTES:  Lab and/or medical tests (such as kidney/liver function)||
2665|118|N|should be done while you are using this medication. Keep all||
2665|119|N|medical and lab appointments. Consult your doctor for more||
2665|120|N|details.||
2665|121|B|||
2665|122|D|MISSED DOSE:  It is important to get each dose of this medication||
2665|123|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2665|124|D|right away for a new dosing schedule. Do not double the dose to||
2665|125|D|catch up.||
2665|126|B|||
2665|127|R|STORAGE:  Consult the product instructions and your pharmacist||
2665|128|R|for storage details. Keep all medications away from children and||
2665|129|R|pets.||
2665|130|R|   Do not flush medications down the toilet or pour them into a||
2665|131|R|drain unless instructed to do so. Properly discard this product||
2665|132|R|when it is expired or no longer needed. Consult your pharmacist||
2665|133|R|or local waste disposal company.||
2665|134|B|||
2665|135|A|Information last revised June 2025.||
2665|136|A|Copyright(c) 2025 First Databank, Inc.||
2665|137|B|||
2666|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2666|002|Z|does NOT have all possible information about this product. This||
2666|003|Z|information does not assure that this product is safe, effective,||
2666|004|Z|or appropriate for you. This information is not individual||
2666|005|Z|medical advice and does not substitute for the advice of your||
2666|006|Z|health care professional. Always ask your health care||
2666|007|Z|professional for complete information about this product and your||
2666|008|Z|specific health needs.||
2666|009|B|||
2666|010|T|DEURUXOLITINIB - ORAL||
2666|011|F|(due-RUX-oh-LI-ti-nib)||
2666|012|B|||
2666|013|C|COMMON BRAND NAME(S): Leqselvi||
2666|014|B|||
2666|015|W|WARNING:  Deuruxolitinib may lower your ability to fight||
2666|016|W|infections. This may make you more likely to get a serious||
2666|017|W|(rarely fatal) infection or make any infection you have worse.||
2666|018|W|People taking deuruxolitinib have had very serious (possibly||
2666|019|W|fatal) infections (such as herpes zoster, tuberculosis). The risk||
2666|020|W|for infections may be higher if you also take other drugs that||
2666|021|W|suppress the immune system (such as cyclosporine). Tell your||
2666|022|W|doctor right away if you have any signs of infections (such as||
2666|023|W|sore throat that doesn't go away, fever, chills, cough, painful||
2666|024|W|skin rash/blisters).||
2666|025|W|   You should have tuberculosis (TB) skin tests before and during||
2666|026|W|treatment with this medication. Tell your doctor if you have been||
2666|027|W|near someone with tuberculosis or have lived or traveled in areas||
2666|028|W|where certain fungal infections (such as coccidioidomycosis,||
2666|029|W|histoplasmosis) are common. These areas include the Ohio and||
2666|030|W|Mississippi River valleys and the southwestern United States.||
2666|031|W|   Though it is very unlikely to occur, there may be a risk of||
2666|032|W|developing cancer (such as lymphoma, skin cancer, lung cancer)||
2666|033|W|with this medication. Your risk may be higher if you are a||
2666|034|W|current or past smoker. Tell your doctor right away if you||
2666|035|W|develop symptoms such as cough that doesn't go away, wheezing,||
2666|036|W|unusual lumps/growths, unexplained weight loss, night sweats,||
2666|037|W|change in appearance or size of moles, or unusual skin changes.||
2666|038|W|   Deuruxolitinib may cause serious (sometimes fatal) problems||
2666|039|W|from blood clots (such as heart attack, stroke, blood clots in||
2666|040|W|the lungs or legs). You may be at an increased risk for blood||
2666|041|W|clots if you are a current or past smoker, or are 50 years of age||
2666|042|W|or older and have at least one risk factor for heart disease.||
2666|043|W|Discuss the risks and benefits of treatment with your doctor. Get||
2666|044|W|medical help right away if any of these symptoms occur: shortness||
2666|045|W|of breath/rapid breathing, chest/jaw/left arm pain, unusual||
2666|046|W|sweating, confusion, sudden dizziness/fainting,||
2666|047|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2666|048|W|trouble speaking, weakness on one side of the body, or sudden||
2666|049|W|vision changes.||
2666|050|B|||
2666|051|U|USES:  This medication is used to treat a certain immune system||
2666|052|U|problem that causes hair loss (alopecia areata). Deuruxolitinib||
2666|053|U|belongs to a class of drugs known as kinase inhibitors.||
2666|054|B|||
2666|055|H|HOW TO USE:  Read the Medication Guide provided by your||
2666|056|H|pharmacist before you start taking deuruxolitinib and each time||
2666|057|H|you get a refill. If you have any questions, ask your doctor or||
2666|058|H|pharmacist.||
2666|059|H|   Take this medication by mouth with or without food as directed||
2666|060|H|by your doctor, usually twice daily.||
2666|061|H|   Use this medication regularly to get the most benefit from it.||
2666|062|H|To help you remember, take it at the same times each day.||
2666|063|H|   Do not increase your dose or use this drug more often or for||
2666|064|H|longer than prescribed. Your condition will not improve any||
2666|065|H|faster, and your risk of side effects will increase.||
2666|066|H|   Tell your doctor if your condition does not get better or if||
2666|067|H|it gets worse.||
2666|068|B|||
2666|069|S|SIDE EFFECTS:  See also Warning section.||
2666|070|S|   Acne may occur. If this effect lasts or gets worse, tell your||
2666|071|S|doctor or pharmacist promptly.||
2666|072|S|   People using this medication may have serious side effects.||
2666|073|S|However, you have been prescribed this drug because your doctor||
2666|074|S|has judged that the benefit to you is greater than the risk of||
2666|075|S|side effects. Careful monitoring by your doctor may decrease your||
2666|076|S|risk.||
2666|077|S|   Tell your doctor right away if you have any serious side||
2666|078|S|effects, including: signs of anemia (such as unusual tiredness,||
2666|079|S|pale skin, fast heartbeat), signs of a serious tear in the||
2666|080|S|stomach or intestinal wall (such as severe stomach/abdominal pain||
2666|081|S|that doesn't go away, fever, severe dizziness, fainting, severe||
2666|082|S|nausea/vomiting).||
2666|083|S|   A very serious allergic reaction to this drug is rare.||
2666|084|S|However, get medical help right away if you notice any symptoms||
2666|085|S|of a serious allergic reaction, including: rash, itching/swelling||
2666|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2666|087|S|breathing.||
2666|088|S|   This is not a complete list of possible side effects. If you||
2666|089|S|notice other effects not listed above, contact your doctor or||
2666|090|S|pharmacist.||
2666|091|S|   In the US -||
2666|092|S|   Call your doctor for medical advice about side effects. You||
2666|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2666|094|S|www.fda.gov/medwatch.||
2666|095|S|   In Canada - Call your doctor for medical advice about side||
2666|096|S|effects. You may report side effects to Health Canada at||
2666|097|S|1-866-234-2345.||
2666|098|B|||
2666|099|P|PRECAUTIONS:  See also Warning section.||
2666|100|P|   Before taking deuruxolitinib, tell your doctor or pharmacist||
2666|101|P|if you are allergic to it; or if you have any other allergies.||
2666|102|P|This product may contain inactive ingredients, which can cause||
2666|103|P|allergic reactions or other problems. Talk to your pharmacist for||
2666|104|P|more details.||
2666|105|P|   Before using this medication, tell your doctor or pharmacist||
2666|106|P|your medical history, especially of: blood clots (such as in the||
2666|107|P|lungs, legs), blood/bone marrow problems (such as low platelets||
2666|108|P|or low white blood cell counts), cancer, heart problems (such as||
2666|109|P|previous heart attack), kidney disease, liver disease (such as||
2666|110|P|hepatitis B or C), past/recent/current infections (such as herpes||
2666|111|P|zoster, HIV infection, tuberculosis), current or past smoking,||
2666|112|P|stomach/intestinal problems (such as ulcers, diverticulitis),||
2666|113|P|stroke.||
2666|114|P|   Deuruxolitinib can make you more likely to get infections or||
2666|115|P|may make current infections worse. Stay away from anyone who has||
2666|116|P|an infection that may easily spread (such as chickenpox,||
2666|117|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2666|118|P|exposed to an infection or for more details.||
2666|119|P|   Tell your health care professional that you are using||
2666|120|P|deuruxolitinib before having any immunizations/vaccinations.||
2666|121|P|Avoid contact with people who have recently received live||
2666|122|P|vaccines (such as flu vaccine inhaled through the nose).||
2666|123|P|   This medication may increase your risk of developing skin||
2666|124|P|cancer. Limit your time in the sun. Avoid tanning booths and||
2666|125|P|sunlamps. Use sunscreen and wear protective clothing when||
2666|126|P|outdoors.||
2666|127|P|   Before having surgery, tell your doctor or dentist about all||
2666|128|P|the products you use (including prescription drugs,||
2666|129|P|nonprescription drugs, and herbal products).||
2666|130|P|   Tell your doctor if you are pregnant or plan to become||
2666|131|P|pregnant. You should not become pregnant while using||
2666|132|P|deuruxolitinib. Deuruxolitinib may harm an unborn baby. Ask about||
2666|133|P|reliable forms of birth control while using this medication. If||
2666|134|P|you become pregnant, talk to your doctor right away about the||
2666|135|P|risks and benefits of this medication.||
2666|136|P|   It is unknown if this medication passes into breast milk.||
2666|137|P|Because of the possible risk to the infant, breastfeeding is not||
2666|138|P|recommended while using this medication and for 1 day after the||
2666|139|P|last dose. Consult your doctor before breastfeeding.||
2666|140|B|||
2666|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2666|142|I|medications work or increase your risk for serious side effects.||
2666|143|I|This document does not contain all possible drug interactions.||
2666|144|I|Keep a list of all the products you use (including||
2666|145|I|prescription/nonprescription drugs and herbal products) and share||
2666|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
2666|147|I|the dosage of any medicines without your doctor's approval.||
2666|148|I|   Other medications can affect the removal of deuruxolitinib||
2666|149|I|from your body, which may affect how deuruxolitinib works.||
2666|150|I|Examples include amiodarone, fluconazole, mifepristone,||
2666|151|I|nitisinone, oxandrolone, rifampin, among others.||
2666|152|B|||
2666|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2666|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2666|155|O|poison control center right away. US residents can call||
2666|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2666|157|B|||
2666|158|N|NOTES:  Do not share this medication with others.||
2666|159|N|   Lab and/or medical tests (such as complete blood count, blood||
2666|160|N|cholesterol/triglyceride levels, skin exam) should be done before||
2666|161|N|you start taking this medication and while you are taking it.||
2666|162|N|Keep all medical and lab appointments. Consult your doctor for||
2666|163|N|more details.||
2666|164|B|||
2666|165|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2666|166|D|next dose at the regular time. Do not double the dose to catch||
2666|167|D|up.||
2666|168|B|||
2666|169|R|STORAGE:  Store in the original bottle at room temperature away||
2666|170|R|from light and moisture. Do not store in the bathroom. Keep all||
2666|171|R|medications away from children and pets.||
2666|172|R|   Do not flush medications down the toilet or pour them into a||
2666|173|R|drain unless instructed to do so. Properly discard this product||
2666|174|R|when it is expired or no longer needed. Consult your pharmacist||
2666|175|R|or local waste disposal company.||
2666|176|B|||
2666|177|M|MEDICAL ALERT:  Your condition can cause complications in a||
2666|178|M|medical emergency. For information about enrolling in MedicAlert,||
2666|179|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2666|180|B|||
2666|181|A|Information last revised July 2025.||
2666|182|A|Copyright(c) 2025 First Databank, Inc.||
2666|183|B|||
2667|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2667|002|Z|does NOT have all possible information about this product. This||
2667|003|Z|information does not assure that this product is safe, effective,||
2667|004|Z|or appropriate for you. This information is not individual||
2667|005|Z|medical advice and does not substitute for the advice of your||
2667|006|Z|health care professional. Always ask your health care||
2667|007|Z|professional for complete information about this product and your||
2667|008|Z|specific health needs.||
2667|009|B|||
2667|010|T|BERDAZIMER - TOPICAL||
2667|011|F|(ber-DAZ-i-mer)||
2667|012|B|||
2667|013|C|COMMON BRAND NAME(S): Zelsuvmi||
2667|014|B|||
2667|015|U|USES:  This medication is used to treat a certain viral skin||
2667|016|U|infection (molluscum contagiosum).||
2667|017|B|||
2667|018|H|HOW TO USE:  Read the Patient Information Leaflet and||
2667|019|H|Instructions for Use if available from your pharmacist before you||
2667|020|H|start using berdazimer and each time you get a refill. If you||
2667|021|H|have any questions, ask your doctor or pharmacist.||
2667|022|H|   Wash and dry your hands before preparing and applying the||
2667|023|H|medication. This product comes as a gel in 2 tubes. The gels must||
2667|024|H|be placed on the Dosing Guide and mixed as directed before using||
2667|025|H|on the skin. Once mixed, the medication should be used right||
2667|026|H|away. Do not premix the gel or store the mixed gel for later use.||
2667|027|H|   This medication is for use on the skin only. Apply a thin film||
2667|028|H|of this medication to the affected area (bumps) as directed by||
2667|029|H|your doctor, usually once daily. Wash your hands after applying,||
2667|030|H|unless you are treating your hands. Avoid getting this medication||
2667|031|H|in your eyes, mouth, vagina, open wounds, or unaffected skin. If||
2667|032|H|this happens, rinse right away with plenty of water.||
2667|033|H|   Wait at least 10 minutes to allow the medication to dry before||
2667|034|H|putting clothes over the area. Do not swim, bathe, or shower for||
2667|035|H|at least 1 hour after applying the medication.||
2667|036|H|   Use this medication regularly to get the most benefit from it.||
2667|037|H|To help you remember, use it at the same time each day.||
2667|038|H|   Tell your doctor if your condition does not get better or if||
2667|039|H|it gets worse.||
2667|040|B|||
2667|041|S|SIDE EFFECTS:  Pain, itching, swelling, peeling, redness or||
2667|042|S|change in skin color may occur at the treated area. If any of||
2667|043|S|these effects last or get worse, tell your doctor or pharmacist||
2667|044|S|promptly.||
2667|045|S|   Remember that this medication has been prescribed because your||
2667|046|S|doctor has judged that the benefit to you is greater than the||
2667|047|S|risk of side effects. Many people using this medication do not||
2667|048|S|have serious side effects.||
2667|049|S|   Tell your doctor right away if you have any serious side||
2667|050|S|effects, including: pain/itching/swelling/redness at the treated||
2667|051|S|area that lasts for more than 24 hours.||
2667|052|S|   A very serious allergic reaction to this drug is rare.||
2667|053|S|However, get medical help right away if you notice any symptoms||
2667|054|S|of a serious allergic reaction, including: rash, itching/swelling||
2667|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2667|056|S|breathing.||
2667|057|S|   This is not a complete list of possible side effects. If you||
2667|058|S|notice other effects not listed above, contact your doctor or||
2667|059|S|pharmacist.||
2667|060|S|   In the US -||
2667|061|S|   Call your doctor for medical advice about side effects. You||
2667|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2667|063|S|www.fda.gov/medwatch.||
2667|064|S|   In Canada - Call your doctor for medical advice about side||
2667|065|S|effects. You may report side effects to Health Canada at||
2667|066|S|1-866-234-2345.||
2667|067|B|||
2667|068|P|PRECAUTIONS:  Before using berdazimer, tell your doctor or||
2667|069|P|pharmacist if you are allergic to it; or if you have any other||
2667|070|P|allergies. This product may contain inactive ingredients, which||
2667|071|P|can cause allergic reactions or other problems. Talk to your||
2667|072|P|pharmacist for more details.||
2667|073|P|   Before using this medication, tell your doctor or pharmacist||
2667|074|P|your medical history.||
2667|075|P|   Before having surgery, tell your doctor or dentist about all||
2667|076|P|the products you use (including prescription drugs,||
2667|077|P|nonprescription drugs, and herbal products).||
2667|078|P|   During pregnancy, this medication should be used only when||
2667|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
2667|080|P|   It is unknown if this drug passes into breast milk. Consult||
2667|081|P|your doctor before breastfeeding.||
2667|082|B|||
2667|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2667|084|I|medications work or increase your risk for serious side effects.||
2667|085|I|This document does not contain all possible drug interactions.||
2667|086|I|Keep a list of all the products you use (including||
2667|087|I|prescription/nonprescription drugs and herbal products) and share||
2667|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
2667|089|I|the dosage of any medicines without your doctor's approval.||
2667|090|B|||
2667|091|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2667|092|O|has overdosed and has serious symptoms such as passing out or||
2667|093|O|trouble breathing, call 911. Otherwise, call a poison control||
2667|094|O|center right away. US residents can call 1-800-222-1222. Canada||
2667|095|O|residents can call 1-844-764-7669.||
2667|096|B|||
2667|097|N|NOTES:  Do not share this medication with others.||
2667|098|B|||
2667|099|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
2667|100|D|remember. If it is near the time of the next dose, skip the||
2667|101|D|missed dose. Apply your next dose at the regular time. Do not||
2667|102|D|apply extra medicine to make up for the missed dose.||
2667|103|B|||
2667|104|R|STORAGE:  Store at room temperature away from moisture. Do not||
2667|105|R|freeze. This product is flammable. Keep it away from heat and||
2667|106|R|open flame. This product expires 60 days after you receive it||
2667|107|R|from the pharmacy. Keep all medications away from children and||
2667|108|R|pets.||
2667|109|R|   Do not flush medications down the toilet or pour them into a||
2667|110|R|drain unless instructed to do so. Properly discard this product||
2667|111|R|when it is expired or no longer needed. Consult your pharmacist||
2667|112|R|or local waste disposal company.||
2667|113|B|||
2667|114|A|Information last revised June 2025.||
2667|115|A|Copyright(c) 2025 First Databank, Inc.||
2667|116|B|||
2668|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2668|002|Z|does NOT have all possible information about this product. This||
2668|003|Z|information does not assure that this product is safe, effective,||
2668|004|Z|or appropriate for you. This information is not individual||
2668|005|Z|medical advice and does not substitute for the advice of your||
2668|006|Z|health care professional. Always ask your health care||
2668|007|Z|professional for complete information about this product and your||
2668|008|Z|specific health needs.||
2668|009|B|||
2668|010|T|CLESROVIMAB - INJECTION||
2668|011|F|(KLES-roe-VYE-mab)||
2668|012|B|||
2668|013|C|COMMON BRAND NAME(S): Enflonsia||
2668|014|B|||
2668|015|U|USES:  Clesrovimab is given to infants to prevent serious lung||
2668|016|U|infections (such as pneumonia) that are caused the respiratory||
2668|017|U|syncytial virus (RSV). Clesrovimab belongs to a class of drugs||
2668|018|U|known as monoclonal antibodies. It works by preventing the growth||
2668|019|U|of the virus.||
2668|020|B|||
2668|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2668|022|H|from the health care professional before your child receives||
2668|023|H|clesrovimab. If you have any questions, ask the doctor or||
2668|024|H|pharmacist.||
2668|025|H|   This medication is given by injection into a muscle by a||
2668|026|H|health care professional. It is usually given in the upper thigh.||
2668|027|H|It is given as directed by your child's doctor, usually as a||
2668|028|H|single dose before or during the child's first RSV season.||
2668|029|H|   Some children may need another dose of clesrovimab to get the||
2668|030|H|best protection. Closely follow the treatment schedule provided||
2668|031|H|by the doctor.||
2668|032|B|||
2668|033|S|SIDE EFFECTS:  Pain, redness, or swelling at the injection site||
2668|034|S|may occur. If any of these effects last or get worse, tell the||
2668|035|S|doctor or pharmacist promptly.||
2668|036|S|   Remember that this medication has been prescribed because the||
2668|037|S|doctor has judged that the benefit to your child is greater than||
2668|038|S|the risk of side effects. Many people using this medication do||
2668|039|S|not have serious side effects.||
2668|040|S|   A very serious allergic reaction to this drug is rare.||
2668|041|S|However, get medical help right away if you notice any symptoms||
2668|042|S|of a serious allergic reaction, including: bluish skin/lips,||
2668|043|S|muscle weakness, rash, itching/swelling (especially of the||
2668|044|S|face/tongue/throat), severe dizziness, trouble breathing.||
2668|045|S|   This is not a complete list of possible side effects. If you||
2668|046|S|notice other effects not listed above, contact your doctor or||
2668|047|S|pharmacist.||
2668|048|S|   In the US -||
2668|049|S|   Call your doctor for medical advice about side effects. You||
2668|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2668|051|S|www.fda.gov/medwatch.||
2668|052|S|   In Canada - Call your doctor for medical advice about side||
2668|053|S|effects. You may report side effects to Health Canada at||
2668|054|S|1-866-234-2345.||
2668|055|B|||
2668|056|P|PRECAUTIONS:  Before receiving clesrovimab, tell the doctor or||
2668|057|P|pharmacist if your child is allergic to it; or if your child has||
2668|058|P|any other allergies. This product may contain inactive||
2668|059|P|ingredients, which can cause allergic reactions or other||
2668|060|P|problems. Talk to the pharmacist for more details.||
2668|061|P|   Before receiving this medication, tell the doctor or||
2668|062|P|pharmacist your child's medical history, especially of:||
2668|063|P|bleeding/blood clotting problems (such as low platelets,||
2668|064|P|coagulation disorder).||
2668|065|P|   Before having surgery (especially certain heart procedures),||
2668|066|P|tell the doctor or dentist about this medication and all the||
2668|067|P|products your child uses (including prescription drugs,||
2668|068|P|nonprescription drugs, and herbal products).||
2668|069|P|   This medication is not usually used by adults. It is unlikely||
2668|070|P|to be used during pregnancy or breastfeeding. Consult the doctor||
2668|071|P|if you have any questions about this medication.||
2668|072|B|||
2668|073|I|DRUG INTERACTIONS:  Drug interactions may change how your child's||
2668|074|I|medications work or increase the risk for serious side effects.||
2668|075|I|This document does not contain all possible drug interactions.||
2668|076|I|Keep a list of all the products your child uses (including||
2668|077|I|prescription/nonprescription drugs and herbal products) and share||
2668|078|I|it with the doctor and pharmacist. Do not start, stop, or change||
2668|079|I|the dosage of any medicines without the doctor's approval.||
2668|080|I|   This medication may interfere with certain lab tests (such as||
2668|081|I|RSV diagnostic tests), possibly causing false test results. Make||
2668|082|I|sure lab personnel and all the doctors know your child is using||
2668|083|I|this drug.||
2668|084|B|||
2668|085|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2668|086|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2668|087|O|poison control center right away. US residents can call||
2668|088|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2668|089|B|||
2668|090|N|NOTES:  Keep all medical and lab appointments.||
2668|091|B|||
2668|092|D|MISSED DOSE:  Not applicable.||
2668|093|B|||
2668|094|R|STORAGE:  Not applicable. This medication is given in a hospital||
2668|095|R|or clinic and will not be stored at home.||
2668|096|B|||
2668|097|A|Information last revised June 2025.||
2668|098|A|Copyright(c) 2025 First Databank, Inc.||
2668|099|B|||
2669|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2669|002|Z|does NOT have all possible information about this product. This||
2669|003|Z|information does not assure that this product is safe, effective,||
2669|004|Z|or appropriate for you. This information is not individual||
2669|005|Z|medical advice and does not substitute for the advice of your||
2669|006|Z|health care professional. Always ask your health care||
2669|007|Z|professional for complete information about this product and your||
2669|008|Z|specific health needs.||
2669|009|B|||
2669|010|T|HYDROCORTISONE SOLUTION - ORAL||
2669|011|F|(HYE-droe-KOR-ti-sone)||
2669|012|B|||
2669|013|C|COMMON BRAND NAME(S): Khindivi||
2669|014|B|||
2669|015|U|USES:  Hydrocortisone is a human-made version of a natural||
2669|016|U|substance (cortisol) made by the adrenal gland. This drug is used||
2669|017|U|to treat low cortisol levels caused by diseases of the adrenal||
2669|018|U|gland (such as Addison's disease, adrenocortical insufficiency).||
2669|019|U|Hydrocortisone belongs to a class of drugs known as||
2669|020|U|corticosteroids. Corticosteroids are needed in many ways for the||
2669|021|U|body to function well. They are important for salt and water||
2669|022|U|balance and keeping blood pressure normal.||
2669|023|B|||
2669|024|V|OTHER USES:  This section contains uses of this drug that are not||
2669|025|V|listed in the approved professional labeling for the drug but||
2669|026|V|that may be prescribed by your health care professional. Use this||
2669|027|V|drug for a condition that is listed in this section only if it||
2669|028|V|has been so prescribed by your health care professional.||
2669|029|V|   Hydrocortisone may also be used for arthritis, blood/immune||
2669|030|V|system disorders, skin and eye conditions, breathing problems,||
2669|031|V|cancer, and severe allergies. Hydrocortisone may also be used for||
2669|032|V|COVID-19, but is only effective in hospitalized patients who need||
2669|033|V|extra oxygen or a mechanical ventilator to breathe.||
2669|034|B|||
2669|035|H|HOW TO USE:  Read the Medication Guide provided by your||
2669|036|H|pharmacist before you start taking hydrocortisone and each time||
2669|037|H|you get a refill. If you have any questions, ask your doctor or||
2669|038|H|pharmacist.||
2669|039|H|   Take this medication by mouth with or without food as directed||
2669|040|H|by your doctor, usually 2 or 3 times daily. Carefully measure the||
2669|041|H|dose using a special measuring device/spoon. Do not use a||
2669|042|H|household spoon because you may not get the correct dose. Drink||
2669|043|H|some water after taking the medication to make sure all the||
2669|044|H|medication is swallowed.||
2669|045|H|   This medication may also be given through a tube into the||
2669|046|H|stomach (gastric tube). If you are giving this medication through||
2669|047|H|a nasogastric or gastric tube, ask your health care professional||
2669|048|H|for detailed instructions on how to give it.||
2669|049|H|   The dosage is based on your medical condition, body size, and||
2669|050|H|response to treatment.||
2669|051|H|   Do not stop taking this medication without consulting your||
2669|052|H|doctor. Some conditions may become worse when this drug is||
2669|053|H|suddenly stopped.||
2669|054|H|   If you suddenly stop using this medication, you may have||
2669|055|H|withdrawal symptoms (such as weakness, weight loss, nausea,||
2669|056|H|muscle pain, headache, tiredness, dizziness). To help prevent||
2669|057|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
2669|058|H|more likely if you have used hydrocortisone for a long time or in||
2669|059|H|high doses. Tell your doctor or pharmacist right away if you have||
2669|060|H|withdrawal.||
2669|061|H|   Tell your doctor if your condition does not get better or if||
2669|062|H|it gets worse.||
2669|063|B|||
2669|064|S|SIDE EFFECTS:  Nausea, vomiting, headache, trouble sleeping,||
2669|065|S|increased sweating, or acne may occur. If any of these effects||
2669|066|S|last or get worse, tell your doctor or pharmacist promptly.||
2669|067|S|   Remember that this medication has been prescribed because your||
2669|068|S|doctor has judged that the benefit to you is greater than the||
2669|069|S|risk of side effects. Many people using this medication do not||
2669|070|S|have serious side effects.||
2669|071|S|   Tell your doctor right away if you have any serious side||
2669|072|S|effects, including: signs of infection (such as sore throat that||
2669|073|S|doesn't go away, fever, chills), weakness, swelling ankles/feet,||
2669|074|S|unusual weight gain, vision problems (such as blurred vision),||
2669|075|S|easy bruising/bleeding, puffy face, mental/mood changes (such as||
2669|076|S|depression, mood swings, agitation, confusion), muscle||
2669|077|S|pain/cramps, thinning skin, slow wound healing, bone pain,||
2669|078|S|menstrual period changes, irregular heartbeat, seizures,||
2669|079|S|red/purple spots on the skin, symptoms of stomach/intestinal||
2669|080|S|bleeding (such as stomach/abdominal pain, black/tarry stools,||
2669|081|S|vomit that looks like coffee grounds).||
2669|082|S|   This medication may rarely make your blood sugar rise, which||
2669|083|S|can cause or worsen diabetes. Tell your doctor right away if you||
2669|084|S|have symptoms of high blood sugar such as increased||
2669|085|S|thirst/urination. If you already have diabetes, check your blood||
2669|086|S|sugar regularly as directed and share the results with your||
2669|087|S|doctor. Your doctor may need to adjust your diabetes medication,||
2669|088|S|exercise program, or diet.||
2669|089|S|   A very serious allergic reaction to this drug is rare.||
2669|090|S|However, get medical help right away if you notice any symptoms||
2669|091|S|of a serious allergic reaction, including: rash, itching/swelling||
2669|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2669|093|S|breathing.||
2669|094|S|   This is not a complete list of possible side effects. If you||
2669|095|S|notice other effects not listed above, contact your doctor or||
2669|096|S|pharmacist.||
2669|097|S|   In the US -||
2669|098|S|   Call your doctor for medical advice about side effects. You||
2669|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2669|100|S|www.fda.gov/medwatch.||
2669|101|S|   In Canada - Call your doctor for medical advice about side||
2669|102|S|effects. You may report side effects to Health Canada at||
2669|103|S|1-866-234-2345.||
2669|104|B|||
2669|105|P|PRECAUTIONS:  Before taking hydrocortisone, tell your doctor or||
2669|106|P|pharmacist if you are allergic to it; or if you have any other||
2669|107|P|allergies. This product may contain inactive ingredients (such as||
2669|108|P|propylene glycol), which can cause allergic reactions or other||
2669|109|P|problems. Talk to your pharmacist for more details.||
2669|110|P|   Before using this medication, tell your doctor or pharmacist||
2669|111|P|your medical history, especially of: eye disease (such as||
2669|112|P|cataracts, glaucoma), heart problems (such as heart failure,||
2669|113|P|recent heart attack), high blood pressure, liver disease (such as||
2669|114|P|hepatitis B), kidney disease, thyroid problems, diabetes,||
2669|115|P|stomach/intestinal problems (such as diverticulitis, ulcer), bone||
2669|116|P|loss (osteoporosis), current/past infections (such as||
2669|117|P|tuberculosis, herpes, fungal infection), bleeding problems, blood||
2669|118|P|clots, mental/mood disorders (such as psychosis, anxiety,||
2669|119|P|depression), mineral imbalance (such as low level of||
2669|120|P|potassium/calcium in the blood), seizures, a certain adrenal||
2669|121|P|gland tumor (pheochromocytoma).||
2669|122|P|   This medication may cause stomach bleeding. Daily use of||
2669|123|P|alcohol while using this medication may increase your risk for||
2669|124|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
2669|125|P|or pharmacist for more information.||
2669|126|P|   Before having surgery, tell your doctor or dentist about all||
2669|127|P|the products you use (including prescription drugs,||
2669|128|P|nonprescription drugs, and herbal products).||
2669|129|P|   Using corticosteroid medications for a long time can make it||
2669|130|P|more difficult for your body to respond to physical stress.||
2669|131|P|Before having surgery or emergency treatment, or if you get a||
2669|132|P|serious illness/injury, tell your doctor or dentist that you are||
2669|133|P|using this medication or have used this medication within the||
2669|134|P|past 12 months. Your doctor may switch you to another form of||
2669|135|P|this medication. Tell your doctor right away if you develop||
2669|136|P|unusual/extreme tiredness or weight loss. If you will be using||
2669|137|P|this medication for a long time, carry a warning card or medical||
2669|138|P|ID bracelet that identifies your use of this medication.||
2669|139|P|   This medication may mask signs of infection. It can make you||
2669|140|P|more likely to get infections or may make current infections||
2669|141|P|worse. Stay away from anyone who has an infection that may easily||
2669|142|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
2669|143|P|doctor if you have been exposed to an infection or for more||
2669|144|P|details.||
2669|145|P|   Tell your health care professional that you are using||
2669|146|P|hydrocortisone before having any immunizations/vaccinations.||
2669|147|P|Avoid contact with people who have recently received live||
2669|148|P|vaccines (such as flu vaccine inhaled through the nose).||
2669|149|P|   This medication may slow down a child's growth if used for a||
2669|150|P|long time. Consult the doctor or pharmacist for more details. See||
2669|151|P|the doctor regularly so your child's height and growth can be||
2669|152|P|checked.||
2669|153|P|   Older adults may be more sensitive to the effects of this||
2669|154|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
2669|155|P|mental/mood changes (such as confusion).||
2669|156|P|   During pregnancy, hydrocortisone should be used only when||
2669|157|P|clearly needed. Discuss the risks and benefits with your doctor.||
2669|158|P|Infants born to mothers who have been using this medication for||
2669|159|P|an extended period of time may have hormone problems. Tell your||
2669|160|P|doctor right away if you notice symptoms such as nausea/vomiting||
2669|161|P|that doesn't stop, severe diarrhea, or weakness in your newborn.||
2669|162|P|   It is unknown if this drug passes into breast milk. However,||
2669|163|P|this drug is unlikely to harm a nursing infant. Consult your||
2669|164|P|doctor before breastfeeding.||
2669|165|B|||
2669|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2669|167|I|medications work or increase your risk for serious side effects.||
2669|168|I|This document does not contain all possible drug interactions.||
2669|169|I|Keep a list of all the products you use (including||
2669|170|I|prescription/nonprescription drugs and herbal products) and share||
2669|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
2669|172|I|the dosage of any medicines without your doctor's approval.||
2669|173|I|   Some products that may interact with this drug are:||
2669|174|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
2669|175|I|cause bleeding/bruising (such as antiplatelet drugs like||
2669|176|I|clopidogrel, NSAIDs like ibuprofen/naproxen, "blood thinners"||
2669|177|I|like warfarin/dabigatran).||
2669|178|I|   Aspirin can increase the risk of bleeding when used with this||
2669|179|I|medication. However, if your doctor has told you to take low-dose||
2669|180|I|aspirin to prevent heart attack or stroke (usually 81-162||
2669|181|I|milligrams a day), you should keep taking the aspirin unless your||
2669|182|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2669|183|I|details.||
2669|184|I|   This medication may interfere with certain lab tests (such as||
2669|185|I|skin tests), possibly causing false test results. Make sure lab||
2669|186|I|personnel and all your doctors know you use this drug.||
2669|187|B|||
2669|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2669|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2669|190|O|poison control center right away. US residents can call||
2669|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2669|192|B|||
2669|193|N|NOTES:  Do not share this medication with others.||
2669|194|N|   If this medication is used for a long time, lab and/or medical||
2669|195|N|tests (such as blood sugar/mineral levels, blood counts, blood||
2669|196|N|pressure, bone density tests, eye exams, height/weight||
2669|197|N|measurements, X-rays) should be done while you are taking this||
2669|198|N|medication. Keep all medical and lab appointments. Consult your||
2669|199|N|doctor for more details.||
2669|200|N|   This medication may cause bone loss (osteoporosis) when used||
2669|201|N|for a long time. Lifestyle changes that may help reduce the risk||
2669|202|N|of bone problems include doing weight-bearing exercise, stopping||
2669|203|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
2669|204|N|D. Talk to your doctor for more details.||
2669|205|B|||
2669|206|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2669|207|D|remember. If it is near the time of the next dose, skip the||
2669|208|D|missed dose. Take your next dose at the regular time. Do not||
2669|209|D|double the dose to catch up.||
2669|210|B|||
2669|211|R|STORAGE:  Store in the refrigerator or at room temperature away||
2669|212|R|from light. Do not freeze. Once the bottle is opened, this||
2669|213|R|medication expires after 120 days. Keep all medications away from||
2669|214|R|children and pets.||
2669|215|R|   Do not flush medications down the toilet or pour them into a||
2669|216|R|drain unless instructed to do so. Properly discard this product||
2669|217|R|when it is expired or no longer needed. Consult your pharmacist||
2669|218|R|or local waste disposal company.||
2669|219|B|||
2669|220|M|MEDICAL ALERT:  Your condition can cause complications in a||
2669|221|M|medical emergency. For information about enrolling in MedicAlert,||
2669|222|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2669|223|B|||
2669|224|A|Information last revised September 2025.||
2669|225|A|Copyright(c) 2025 First Databank, Inc.||
2669|226|B|||
2670|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2670|002|Z|does NOT have all possible information about this product. This||
2670|003|Z|information does not assure that this product is safe, effective,||
2670|004|Z|or appropriate for you. This information is not individual||
2670|005|Z|medical advice and does not substitute for the advice of your||
2670|006|Z|health care professional. Always ask your health care||
2670|007|Z|professional for complete information about this product and your||
2670|008|Z|specific health needs.||
2670|009|B|||
2670|010|T|TALETRECTINIB - ORAL||
2670|011|F|(TA-le-TREK-tin-ib)||
2670|012|B|||
2670|013|C|COMMON BRAND NAME(S): Ibtrozi||
2670|014|B|||
2670|015|U|USES:  This medication is used to treat a certain type of lung||
2670|016|U|cancer (non-small cell lung cancer-NSCLC). Taletrectinib works by||
2670|017|U|slowing or stopping the growth of cancer cells. It belongs to a||
2670|018|U|class of drugs known as kinase inhibitors.||
2670|019|B|||
2670|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2670|021|H|from your pharmacist before you start using taletrectinib and||
2670|022|H|each time you get a refill. If you have any questions, ask your||
2670|023|H|doctor or pharmacist.||
2670|024|H|   Take this medication by mouth on an empty stomach as directed||
2670|025|H|by your doctor, usually once daily. Do not eat for at least 2||
2670|026|H|hours before and 2 hours after taking this medication. Swallow||
2670|027|H|the capsules whole. Do not crush or chew the capsules. Do not||
2670|028|H|open or dissolve the contents of the capsules.||
2670|029|H|   The dosage is based on your medical condition and response to||
2670|030|H|treatment.||
2670|031|H|   Medications that reduce stomach acid (such as antacids, proton||
2670|032|H|pump inhibitors/PPIs, H2 blockers) may make taletrectinib work||
2670|033|H|less well. Do not take PPIs (such as lansoprazole, omeprazole) or||
2670|034|H|H2 blockers (such as famotidine, nizatidine) while using this||
2670|035|H|medication. If you take antacids, take it 2 hours before or after||
2670|036|H|taking taletrectinib.||
2670|037|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2670|038|H|using this medication unless your doctor or pharmacist says you||
2670|039|H|may do so safely. Grapefruit can increase the chance of side||
2670|040|H|effects with this medicine. Ask your doctor or pharmacist for||
2670|041|H|more details.||
2670|042|H|   Use this medication regularly to get the most benefit from it.||
2670|043|H|To help you remember, take it at the same time each day.||
2670|044|H|   Do not increase your dose or use this drug more often or for||
2670|045|H|longer than prescribed. Your condition will not improve any||
2670|046|H|faster, and your risk of serious side effects will increase.||
2670|047|H|   If you vomit after taking a dose, do not take an extra dose.||
2670|048|H|Take your next dose at the regular time.||
2670|049|H|   Since this drug can be absorbed through the skin and lungs and||
2670|050|H|may harm an unborn baby, women who are pregnant or who may become||
2670|051|H|pregnant should not handle this medication or breathe the dust||
2670|052|H|from the capsules.||
2670|053|B|||
2670|054|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, constipation,||
2670|055|S|dizziness, or tiredness may occur. If any of these effects last||
2670|056|S|or get worse, tell your doctor or pharmacist promptly.||
2670|057|S|   People using this medication may have serious side effects.||
2670|058|S|However, you have been prescribed this drug because your doctor||
2670|059|S|has judged that the benefit to you is greater than the risk of||
2670|060|S|side effects. Careful monitoring by your doctor may decrease your||
2670|061|S|risk.||
2670|062|S|   Tell your doctor right away if you have any serious side||
2670|063|S|effects, including: muscle pain/tenderness/weakness, signs of||
2670|064|S|high uric acid level in the blood (such as toe/joint pain,||
2670|065|S|painful urination, change in the amount of urine).||
2670|066|S|   Although taletrectinib is used to treat certain types of lung||
2670|067|S|cancers, it may rarely cause other serious (possibly fatal) lung||
2670|068|S|problems. Tell your doctor right away if you have any new or||
2670|069|S|worsening shortness of breath, chest pain, fever, or cough.||
2670|070|S|   Taletrectinib has caused very serious (rarely fatal) liver||
2670|071|S|disease. Tell your doctor right away if you develop symptoms of||
2670|072|S|liver disease, such as nausea/vomiting that doesn't stop,||
2670|073|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
2670|074|S|   Get medical help right away if you have any very serious side||
2670|075|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2670|076|S|fainting.||
2670|077|S|   This medication may increase your risk for bone fractures.||
2670|078|S|Fractures may happen with or without a fall or injury. Tell your||
2670|079|S|health care provider right away if you have bone pain or changes||
2670|080|S|in movement.||
2670|081|S|   Taletrectinib can commonly cause a rash that is usually not||
2670|082|S|serious. However, you may not be able to tell it apart from a||
2670|083|S|rare rash that could be a sign of a severe reaction. Tell your||
2670|084|S|doctor right away if you develop any rash.||
2670|085|S|   A very serious allergic reaction to this drug is rare.||
2670|086|S|However, get medical help right away if you notice any symptoms||
2670|087|S|of a serious allergic reaction, including: rash, itching/swelling||
2670|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2670|089|S|breathing.||
2670|090|S|   This is not a complete list of possible side effects. If you||
2670|091|S|notice other effects not listed above, contact your doctor or||
2670|092|S|pharmacist.||
2670|093|S|   In the US -||
2670|094|S|   Call your doctor for medical advice about side effects. You||
2670|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2670|096|S|www.fda.gov/medwatch.||
2670|097|S|   In Canada - Call your doctor for medical advice about side||
2670|098|S|effects. You may report side effects to Health Canada at||
2670|099|S|1-866-234-2345.||
2670|100|B|||
2670|101|P|PRECAUTIONS:  Before taking taletrectinib, tell your doctor or||
2670|102|P|pharmacist if you are allergic to it; or if you have any other||
2670|103|P|allergies. This product may contain inactive ingredients, which||
2670|104|P|can cause allergic reactions or other problems. Talk to your||
2670|105|P|pharmacist for more details.||
2670|106|P|   Before using this medication, tell your doctor or pharmacist||
2670|107|P|your medical history, especially of: liver problems, gout.||
2670|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2670|109|P|can make you more dizzy. Do not drive, use machinery, or do||
2670|110|P|anything that needs alertness or clear vision until you can do it||
2670|111|P|safely. Limit alcoholic beverages. Talk to your doctor if you are||
2670|112|P|using marijuana (cannabis).||
2670|113|P|   Taletrectinib may cause a condition that affects the heart||
2670|114|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2670|115|P|serious (rarely fatal) fast/irregular heartbeat and other||
2670|116|P|symptoms (such as severe dizziness, fainting) that need medical||
2670|117|P|attention right away.||
2670|118|P|   The risk of QT prolongation may be increased if you have||
2670|119|P|certain medical conditions or are taking other drugs that may||
2670|120|P|cause QT prolongation. Before using taletrectinib, tell your||
2670|121|P|doctor or pharmacist of all the drugs you take and if you have||
2670|122|P|any of the following conditions: certain heart problems (heart||
2670|123|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2670|124|P|history of certain heart problems (QT prolongation in the EKG,||
2670|125|P|sudden cardiac death).||
2670|126|P|   Low levels of potassium or magnesium in the blood may also||
2670|127|P|increase your risk of QT prolongation. This risk may increase if||
2670|128|P|you use certain drugs (such as diuretics/"water pills") or if you||
2670|129|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2670|130|P|Talk to your doctor about using taletrectinib safely.||
2670|131|P|   This medication may make you more sensitive to the sun. Limit||
2670|132|P|your time in the sun during treatment and for at least 5 days||
2670|133|P|after the last dose. Avoid tanning booths and sunlamps. Use||
2670|134|P|sunscreen and wear protective clothing when outdoors. Tell your||
2670|135|P|doctor right away if you get sunburned or have skin||
2670|136|P|blisters/redness.||
2670|137|P|   Before having surgery, tell your doctor or dentist about all||
2670|138|P|the products you use (including prescription drugs,||
2670|139|P|nonprescription drugs, and herbal products).||
2670|140|P|   Older adults may be more sensitive to the side effects of this||
2670|141|P|drug, especially QT prolongation (see above).||
2670|142|P|   Since this drug can be absorbed through the skin and lungs and||
2670|143|P|may harm an unborn baby, women who are pregnant or who may become||
2670|144|P|pregnant should not handle this medication or breathe the dust||
2670|145|P|from the capsules.||
2670|146|P|   Tell your doctor if you are pregnant or plan to become||
2670|147|P|pregnant. You should not become pregnant while using||
2670|148|P|taletrectinib. Taletrectinib may harm an unborn baby. Your doctor||
2670|149|P|should order a pregnancy test before you start this medication.||
2670|150|P|Men and women using this medication should ask about reliable||
2670|151|P|forms of birth control during treatment and for at least 3 weeks||
2670|152|P|after the last dose. If you or your partner becomes pregnant,||
2670|153|P|talk to your doctor right away about the risks and benefits of||
2670|154|P|this medication.||
2670|155|P|   It is unknown if this medication passes into breast milk.||
2670|156|P|Because of the possible risk to the infant, breastfeeding is not||
2670|157|P|recommended while using this medication and for 3 weeks after the||
2670|158|P|last dose. Consult your doctor before breastfeeding.||
2670|159|B|||
2670|160|I|DRUG INTERACTIONS:  See also How to Use section.||
2670|161|I|   Drug interactions may change how your medications work or||
2670|162|I|increase your risk for serious side effects. This document does||
2670|163|I|not contain all possible drug interactions. Keep a list of all||
2670|164|I|the products you use (including prescription/nonprescription||
2670|165|I|drugs and herbal products) and share it with your doctor and||
2670|166|I|pharmacist. Do not start, stop, or change the dosage of any||
2670|167|I|medicines without your doctor's approval.||
2670|168|I|   Other medications can affect the removal of taletrectinib from||
2670|169|I|your body, which may affect how taletrectinib works. Examples||
2670|170|I|include azole antifungals (such as fluconazole, itraconazole,||
2670|171|I|posaconazole), dronedarone, efavirenz, levoketoconazole,||
2670|172|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
2670|173|I|rifabutin, rifampin), drugs used to treat seizures (such as||
2670|174|I|carbamazepine, phenytoin), verapamil, among others.||
2670|175|B|||
2670|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2670|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2670|178|O|poison control center right away. US residents can call||
2670|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2670|180|B|||
2670|181|N|NOTES:  Do not share this medication with others.||
2670|182|N|   Lab and/or medical tests (such as blood mineral levels, liver||
2670|183|N|function, complete blood counts, heart rate, CPK levels, uric||
2670|184|N|acid levels) should be done before you start taking this||
2670|185|N|medication and while you are taking it. Keep all medical and lab||
2670|186|N|appointments.||
2670|187|B|||
2670|188|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2670|189|D|next dose at the regular time. Do not double the dose to catch||
2670|190|D|up.||
2670|191|B|||
2670|192|R|STORAGE:  Store at room temperature away from light and moisture.||
2670|193|R|Do not store in the bathroom. Keep all medications away from||
2670|194|R|children and pets.||
2670|195|R|   Do not flush medications down the toilet or pour them into a||
2670|196|R|drain unless instructed to do so. Properly discard this product||
2670|197|R|when it is expired or no longer needed. Consult your pharmacist||
2670|198|R|or local waste disposal company.||
2670|199|B|||
2670|200|M|MEDICAL ALERT:  Your condition can cause complications in a||
2670|201|M|medical emergency. For information about enrolling in MedicAlert,||
2670|202|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2670|203|B|||
2670|204|A|Information last revised July 2025.||
2670|205|A|Copyright(c) 2025 First Databank, Inc.||
2670|206|B|||
2671|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2671|002|Z|does NOT have all possible information about this product. This||
2671|003|Z|information does not assure that this product is safe, effective,||
2671|004|Z|or appropriate for you. This information is not individual||
2671|005|Z|medical advice and does not substitute for the advice of your||
2671|006|Z|health care professional. Always ask your health care||
2671|007|Z|professional for complete information about this product and your||
2671|008|Z|specific health needs.||
2671|009|B|||
2671|010|T|DESOGESTREL/ETHINYL ESTRADIOL/FERROUS BISGLYCINATE - ORAL||
2671|011|B|||
2671|012|C|COMMON BRAND NAME(S): Averi||
2671|013|B|||
2671|014|W|WARNING:  Smoking raises your risk of stroke, heart attack, blood||
2671|015|W|clots, and high blood pressure from hormonal birth control (such||
2671|016|W|as the pill, patch, ring). The risk of these serious problems||
2671|017|W|increases with age and with the number of cigarettes you smoke.||
2671|018|W|Do not smoke or use tobacco. Do not use this medication if you||
2671|019|W|smoke cigarettes/use tobacco and are over 35 years old.||
2671|020|W|   Accidental overdose of iron-containing products is a leading||
2671|021|W|cause of fatal poisoning in children younger than 6 years. Keep||
2671|022|W|this product out of reach of children. If overdose does occur,||
2671|023|W|get medical help right away or call a poison control center.||
2671|024|B|||
2671|025|U|USES:  This combination hormone medication is used to prevent||
2671|026|U|pregnancy. It contains 2 hormones: desogestrel (a progestin) and||
2671|027|U|ethinyl estradiol (an estrogen). There is a small amount of iron||
2671|028|U|(ferrous bisglycinate) in each of the 7 inactive tablets taken||
2671|029|U|during the fourth week. The inactive pills do not contain any||
2671|030|U|hormones. These tablets are meant to keep you in the habit of||
2671|031|U|taking 1 tablet each day and do not have enough iron to treat||
2671|032|U|iron deficiency.||
2671|033|U|   Besides preventing pregnancy, birth control pills may make||
2671|034|U|your periods more regular, decrease blood loss and painful||
2671|035|U|periods, and decrease your risk of ovarian cysts.||
2671|036|U|   This medication does not protect against sexually transmitted||
2671|037|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
2671|038|U|an effective barrier method (latex or polyurethane condom/dental||
2671|039|U|dams) during sexual activity will help to decrease your risk of||
2671|040|U|infection.||
2671|041|B|||
2671|042|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
2671|043|H|your pharmacist before you start using this product and each time||
2671|044|H|you get a refill. The leaflet contains very important information||
2671|045|H|on when to take your pills and what to do if you miss a dose. If||
2671|046|H|you have any questions, ask your doctor or pharmacist.||
2671|047|H|   Take this medication by mouth as directed by your doctor,||
2671|048|H|usually once daily. Pick a time of day that is easy for you to||
2671|049|H|remember, and take your pill at the same time each day.||
2671|050|H|   It is very important to keep taking this medication exactly as||
2671|051|H|prescribed by your doctor. Follow the package instructions to||
2671|052|H|find the first tablet, start with the first tablet in the pack,||
2671|053|H|and take them in the correct order. Do not skip any doses.||
2671|054|H|Pregnancy is more likely if you miss pills, start a new pack||
2671|055|H|late, or take your pill at a different time of the day than||
2671|056|H|usual.||
2671|057|H|   Vomiting or diarrhea can prevent your birth control pills from||
2671|058|H|working well. If vomiting or diarrhea continues, use a backup||
2671|059|H|birth control method (such as condoms, spermicide) and check with||
2671|060|H|your doctor or pharmacist for more details.||
2671|061|H|   Taking this medication after your evening meal or at bedtime||
2671|062|H|may help if you have any stomach upset or nausea with the||
2671|063|H|medication. You may choose to take this medication at another||
2671|064|H|time of day that is easier for you to remember. No matter what||
2671|065|H|dosing schedule you use, it is very important that you take this||
2671|066|H|medication at the same time each day, 24 hours apart.||
2671|067|H|   Your pill pack contains 21 pills with active medication. It||
2671|068|H|also contains 7 reminder pills with iron. Take one active pill||
2671|069|H|(with hormones) once daily for 21 days in a row. Take one||
2671|070|H|inactive pill (with iron) once daily for 7 days in a row after||
2671|071|H|you have taken the last active pill unless otherwise directed by||
2671|072|H|your doctor. You should have your period during the fourth week||
2671|073|H|of the pack. After you have taken the last iron tablet in the||
2671|074|H|pack, start a new pack the next day even if your period is||
2671|075|H|continuing or if you do not have your period. If you do not get||
2671|076|H|your period, consult your doctor.||
2671|077|H|   If this is the first time you are using this medication and||
2671|078|H|you are not switching from another form of hormonal birth control||
2671|079|H|(such as patch, other birth control pills), take the first tablet||
2671|080|H|in the pack on the first Sunday following the beginning of your||
2671|081|H|menstrual period or on the first day of your period. If your||
2671|082|H|period begins on a Sunday, begin taking this medication on that||
2671|083|H|day. For the first cycle of use only, use a backup form of||
2671|084|H|non-hormonal birth control (such as condoms, spermicide) for the||
2671|085|H|first 7 days to prevent pregnancy until the medication has enough||
2671|086|H|time to work. If you start on the first day of your period, you||
2671|087|H|do not need to use backup birth control the first week.||
2671|088|H|   Ask your doctor or pharmacist for information about how to||
2671|089|H|switch from other forms of hormonal birth control (such as patch,||
2671|090|H|other birth control pills) to this product. If any information is||
2671|091|H|unclear, consult the Patient Information Leaflet or your doctor||
2671|092|H|or pharmacist.||
2671|093|B|||
2671|094|S|SIDE EFFECTS:  Nausea, vomiting, headache, abdominal||
2671|095|S|cramps/bloating, breast tenderness, swelling ankles/feet, or||
2671|096|S|weight change may occur. Vaginal bleeding between periods||
2671|097|S|(spotting) or missed/irregular periods may occur, especially||
2671|098|S|during the first few months of use. If any of these effects last||
2671|099|S|or get worse, tell your doctor or pharmacist promptly. If you||
2671|100|S|miss 2 periods in a row (or 1 period if the pill has not been||
2671|101|S|used properly), contact your doctor for a pregnancy test.||
2671|102|S|   Remember that this medication has been prescribed because your||
2671|103|S|doctor has judged that the benefit to you is greater than the||
2671|104|S|risk of side effects. Many people using this medication do not||
2671|105|S|have serious side effects.||
2671|106|S|   This medication may raise your blood pressure. Check your||
2671|107|S|blood pressure regularly and tell your doctor if the results are||
2671|108|S|high.||
2671|109|S|   Tell your doctor right away if you have any serious side||
2671|110|S|effects, including: lumps in the breast, mental/mood changes||
2671|111|S|(such as new/worsening depression), unusual changes in vaginal||
2671|112|S|bleeding (such as continuous spotting, sudden heavy bleeding),||
2671|113|S|stomach/abdominal pain, dark urine, yellowing eyes/skin.||
2671|114|S|   This medication may rarely cause serious (sometimes fatal)||
2671|115|S|problems from blood clots (such as heart attack, stroke, blood||
2671|116|S|clots in the lungs or legs). Get medical help right away if you||
2671|117|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
2671|118|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
2671|119|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2671|120|S|trouble speaking, weakness on one side of the body, sudden vision||
2671|121|S|changes.||
2671|122|S|   A very serious allergic reaction to this drug is rare.||
2671|123|S|However, get medical help right away if you notice any symptoms||
2671|124|S|of a serious allergic reaction, including: rash, itching/swelling||
2671|125|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2671|126|S|breathing.||
2671|127|S|   This is not a complete list of possible side effects. If you||
2671|128|S|notice other effects not listed above, contact your doctor or||
2671|129|S|pharmacist.||
2671|130|S|   In the US -||
2671|131|S|   Call your doctor for medical advice about side effects. You||
2671|132|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2671|133|S|www.fda.gov/medwatch.||
2671|134|S|   In Canada - Call your doctor for medical advice about side||
2671|135|S|effects. You may report side effects to Health Canada at||
2671|136|S|1-866-234-2345.||
2671|137|B|||
2671|138|P|PRECAUTIONS:  See also Warning section.||
2671|139|P|   Before using this medication, tell your doctor or pharmacist||
2671|140|P|if you are allergic to ethinyl estradiol, desogestrel, or ferrous||
2671|141|P|bisglycinate; or to other estrogens, progestins, or iron||
2671|142|P|products; or if you have any other allergies. This product may||
2671|143|P|contain inactive ingredients, which can cause allergic reactions||
2671|144|P|or other problems. Talk to your pharmacist for more details.||
2671|145|P|   Before using this medication, tell your doctor or pharmacist||
2671|146|P|your medical history, especially of: blood clots (for example, in||
2671|147|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
2671|148|P|C or protein S deficiency), high blood pressure, abnormal breast||
2671|149|P|exam, cancer (especially endometrial or breast cancer), high||
2671|150|P|cholesterol or triglyceride (blood fat) levels, depression,||
2671|151|P|diabetes, family or personal history of a certain swelling||
2671|152|P|disorder (angioedema), gallbladder problems, severe||
2671|153|P|headaches/migraines, heart problems (such as heart valve disease,||
2671|154|P|irregular heartbeat, previous heart attack), history of yellowing||
2671|155|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
2671|156|P|birth control (such as pills, patch), kidney disease, liver||
2671|157|P|disease (including tumors), obesity, stroke, swelling (edema),||
2671|158|P|thyroid problems, unexplained vaginal bleeding.||
2671|159|P|   If you have diabetes, this medication may affect your blood||
2671|160|P|sugar. Check your blood sugar regularly as directed and share the||
2671|161|P|results with your doctor. Tell your doctor right away if you have||
2671|162|P|symptoms of high blood sugar such as increased thirst/urination.||
2671|163|P|Your doctor may need to adjust your diabetes medication, exercise||
2671|164|P|program, or diet.||
2671|165|P|   Tell your doctor if you just had or will be having surgery or||
2671|166|P|if you will be confined to a bed or chair for a long time (such||
2671|167|P|as a long plane flight). These conditions increase your risk of||
2671|168|P|getting blood clots, especially if you are using hormonal birth||
2671|169|P|control. You may need to stop this medication for a time or take||
2671|170|P|special precautions.||
2671|171|P|   Before having surgery, tell your doctor or dentist about all||
2671|172|P|the products you use (including prescription drugs,||
2671|173|P|nonprescription drugs, and herbal products).||
2671|174|P|   This medication may cause blotchy, dark areas on your face and||
2671|175|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
2671|176|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
2671|177|P|wear protective clothing when outdoors.||
2671|178|P|   If you are nearsighted or wear contact lenses, you may develop||
2671|179|P|vision problems or trouble wearing your contact lenses. Contact||
2671|180|P|your eye doctor if these problems occur.||
2671|181|P|   It may take longer for you to become pregnant after you stop||
2671|182|P|taking birth control pills. Consult your doctor.||
2671|183|P|   This medication should not be used during pregnancy. If you||
2671|184|P|become pregnant or think you may be pregnant, tell your doctor||
2671|185|P|right away. If you have just given birth or had a pregnancy||
2671|186|P|loss/abortion after the first 3 months, talk with your doctor||
2671|187|P|about reliable forms of birth control, and find out when it is||
2671|188|P|safe to start using birth control that contains a form of||
2671|189|P|estrogen, such as this medication.||
2671|190|P|   A small amount of this medication passes into breast milk and||
2671|191|P|may have undesirable effects on a nursing infant. Consult your||
2671|192|P|doctor before breastfeeding.||
2671|193|B|||
2671|194|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2671|195|I|medications work or increase your risk for serious side effects.||
2671|196|I|This document does not contain all possible drug interactions.||
2671|197|I|Keep a list of all the products you use (including||
2671|198|I|prescription/nonprescription drugs and herbal products) and share||
2671|199|I|it with your doctor and pharmacist. Do not start, stop, or change||
2671|200|I|the dosage of any medicines without your doctor's approval.||
2671|201|I|   Some products that may interact with this drug are: aromatase||
2671|202|I|inhibitors (such as anastrozole, exemestane), fezolinetant,||
2671|203|I|ospemifene, tamoxifen, tizanidine, tranexamic acid.||
2671|204|I|   Some drugs may cause hormonal birth control to work less well||
2671|205|I|by decreasing the amount of birth control hormones in your body.||
2671|206|I|This effect can result in pregnancy. Examples include||
2671|207|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
2671|208|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
2671|209|I|seizures (such as barbiturates, carbamazepine, felbamate,||
2671|210|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
2671|211|I|nevirapine), among others.||
2671|212|I|   Tell your doctor when you start any new drug, and discuss if||
2671|213|I|you should use reliable backup birth control. Also tell your||
2671|214|I|doctor if you have any new spotting or breakthrough bleeding,||
2671|215|I|because these may be signs that your birth control is not working||
2671|216|I|well.||
2671|217|I|   The iron in the inactive pill can decrease the absorption of||
2671|218|I|certain drugs, especially if you take them around the same time.||
2671|219|I|These drugs include bisphosphonates (such as alendronate),||
2671|220|I|levodopa, penicillamine, quinolone antibiotics (such as||
2671|221|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
2671|222|I|doxycycline, minocycline), thyroid medications (such as||
2671|223|I|levothyroxine), among others. Ask your doctor or pharmacist if||
2671|224|I|you should throw away the inactive pills (iron tablets) each day||
2671|225|I|rather than taking them.||
2671|226|I|   This medication may interfere with certain lab tests (such as||
2671|227|I|blood clotting factors, thyroid), possibly causing false test||
2671|228|I|results. Make sure lab personnel and all your doctors know you||
2671|229|I|use this drug.||
2671|230|B|||
2671|231|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2671|232|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2671|233|O|poison control center right away. US residents can call||
2671|234|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2671|235|O|Symptoms of overdose may include severe nausea and vomiting,||
2671|236|O|sudden/unusual vaginal bleeding.||
2671|237|B|||
2671|238|N|NOTES:  Do not share this medication with others.||
2671|239|N|   Regular complete physical exams which include lab and/or||
2671|240|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
2671|241|N|Pap smear) should be done while you are taking this medication.||
2671|242|N|Follow your doctor's instructions for examining your breasts, and||
2671|243|N|report any lumps right away. Keep all medical and lab||
2671|244|N|appointments. Consult your doctor for more details.||
2671|245|B|||
2671|246|D|MISSED DOSE:  Refer to the product package information for advice||
2671|247|D|on missed doses. You may need to use backup birth control (such||
2671|248|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
2671|249|D|pharmacist if you have any questions.||
2671|250|D|   If you often forget to take your pills as directed, contact||
2671|251|D|your doctor to discuss switching to another form of birth||
2671|252|D|control.||
2671|253|B|||
2671|254|R|STORAGE:  Store at room temperature away from light and moisture.||
2671|255|R|Do not store in the bathroom. Keep all medications away from||
2671|256|R|children and pets.||
2671|257|R|   Do not flush medications down the toilet or pour them into a||
2671|258|R|drain unless instructed to do so. Properly discard this product||
2671|259|R|when it is expired or no longer needed. Consult your pharmacist||
2671|260|R|or local waste disposal company.||
2671|261|B|||
2671|262|A|Information last revised October 2025.||
2671|263|A|Copyright(c) 2025 First Databank, Inc.||
2671|264|B|||
2672|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2672|002|Z|does NOT have all possible information about this product. This||
2672|003|Z|information does not assure that this product is safe, effective,||
2672|004|Z|or appropriate for you. This information is not individual||
2672|005|Z|medical advice and does not substitute for the advice of your||
2672|006|Z|health care professional. Always ask your health care||
2672|007|Z|professional for complete information about this product and your||
2672|008|Z|specific health needs.||
2672|009|B|||
2672|010|T|MITOMYCIN - INTRAVESICAL||
2672|011|F|(MYE-toe-MYE-sin)||
2672|012|B|||
2672|013|C|COMMON BRAND NAME(S): Zusduri||
2672|014|B|||
2672|015|U|USES:  This medication is used to treat a certain type of cancer||
2672|016|U|(bladder cancer). It works by slowing or stopping the growth of||
2672|017|U|cancer cells.||
2672|018|B|||
2672|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2672|020|H|from your pharmacist before you start using mitomycin and each||
2672|021|H|time you get a treatment. If you have any questions, ask your||
2672|022|H|doctor or pharmacist.||
2672|023|H|   This medication is given into the bladder through a tube||
2672|024|H|(catheter) by a health care professional. It is given as directed||
2672|025|H|by your doctor, usually once weekly for 6 weeks.||
2672|026|H|   Since this drug can be absorbed through the skin and may harm||
2672|027|H|you, be careful to avoid contact with your urine for at least 24||
2672|028|H|hours after each treatment. To avoid splashing, sit down on the||
2672|029|H|toilet seat each time you urinate during the 24-hour period after||
2672|030|H|treatment. When you are done, flush the toilet several times.||
2672|031|H|Afterward, wash your hands, your inner thighs, and genital area||
2672|032|H|well with soap and water. If any urine comes into contact with||
2672|033|H|your clothing, the clothing should be washed right away and||
2672|034|H|separately from your other clothing.||
2672|035|B|||
2672|036|S|SIDE EFFECTS:  Painful/difficult urination may occur. This||
2672|037|S|medication may cause your urine to turn a violet to blue color.||
2672|038|S|This is a normal, harmless effect of the drug. If any of these||
2672|039|S|effects last or get worse, tell your doctor or pharmacist||
2672|040|S|promptly.||
2672|041|S|   People using this medication may have serious side effects.||
2672|042|S|However, you have been prescribed this drug because your doctor||
2672|043|S|has judged that the benefit to you is greater than the risk of||
2672|044|S|side effects. Careful monitoring by your doctor may decrease your||
2672|045|S|risk.||
2672|046|S|   Tell your doctor right away if you have any serious side||
2672|047|S|effects, including: pink/bloody urine, signs of kidney problems||
2672|048|S|(such as change in the amount of urine), low back/side pain||
2672|049|S|(flank pain), signs of infection (such as sore throat that||
2672|050|S|doesn't go away, fever, chills).||
2672|051|S|   A very serious allergic reaction to this drug is rare.||
2672|052|S|However, get medical help right away if you notice any symptoms||
2672|053|S|of a serious allergic reaction, including: rash, itching/swelling||
2672|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2672|055|S|breathing.||
2672|056|S|   This is not a complete list of possible side effects. If you||
2672|057|S|notice other effects not listed above, contact your doctor or||
2672|058|S|pharmacist.||
2672|059|S|   In the US -||
2672|060|S|   Call your doctor for medical advice about side effects. You||
2672|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2672|062|S|www.fda.gov/medwatch.||
2672|063|S|   In Canada - Call your doctor for medical advice about side||
2672|064|S|effects. You may report side effects to Health Canada at||
2672|065|S|1-866-234-2345.||
2672|066|B|||
2672|067|P|PRECAUTIONS:  Before using mitomycin, tell your doctor or||
2672|068|P|pharmacist if you are allergic to it; or if you have any other||
2672|069|P|allergies. This product may contain inactive ingredients, which||
2672|070|P|can cause allergic reactions or other problems. Talk to your||
2672|071|P|pharmacist for more details.||
2672|072|P|   Before using this medication, tell your doctor or pharmacist||
2672|073|P|your medical history, especially of: a hole in the bladder||
2672|074|P|(perforation), kidney disease.||
2672|075|P|   Before having surgery, tell your doctor or dentist about all||
2672|076|P|the products you use (including prescription drugs,||
2672|077|P|nonprescription drugs, and herbal products).||
2672|078|P|   Tell your doctor if you are pregnant or plan to become||
2672|079|P|pregnant. You should not become pregnant while using mitomycin.||
2672|080|P|Mitomycin may harm an unborn baby. Your doctor should order a||
2672|081|P|pregnancy test before you start this medication. Women using this||
2672|082|P|medication should ask about reliable forms of birth control||
2672|083|P|during treatment and for 6 months after the last dose. Men using||
2672|084|P|this medication should ask about reliable forms of birth control||
2672|085|P|during treatment and for 3 months after the last dose. If you or||
2672|086|P|your partner becomes pregnant, talk to your doctor right away||
2672|087|P|about the risks and benefits of this medication.||
2672|088|P|   It is unknown if this drug passes into breast milk. Because of||
2672|089|P|the possible risk to the infant, breastfeeding is not recommended||
2672|090|P|while using this drug and for 1 week after the last dose. Consult||
2672|091|P|your doctor before breastfeeding.||
2672|092|B|||
2672|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2672|094|I|medications work or increase your risk for serious side effects.||
2672|095|I|This document does not contain all possible drug interactions.||
2672|096|I|Keep a list of all the products you use (including||
2672|097|I|prescription/nonprescription drugs and herbal products) and share||
2672|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
2672|099|I|the dosage of any medicines without your doctor's approval.||
2672|100|B|||
2672|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2672|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2672|103|O|poison control center right away. US residents can call||
2672|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2672|105|B|||
2672|106|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
2672|107|N|kidney/liver function) should be done before you start using this||
2672|108|N|medication and while you are using it. Keep all medical and lab||
2672|109|N|appointments. Consult your doctor for more details.||
2672|110|B|||
2672|111|D|MISSED DOSE:  It is important to get each dose of this medication||
2672|112|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2672|113|D|right away for a new dosing schedule.||
2672|114|B|||
2672|115|R|STORAGE:  Not applicable. This medication is given in a hospital||
2672|116|R|or clinic and will not be stored at home.||
2672|117|B|||
2672|118|M|MEDICAL ALERT:  Your condition can cause complications in a||
2672|119|M|medical emergency. For information about enrolling in MedicAlert,||
2672|120|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2672|121|B|||
2672|122|A|Information last revised July 2025.||
2672|123|A|Copyright(c) 2025 First Databank, Inc.||
2672|124|B|||
2673|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2673|002|Z|does NOT have all possible information about this product. This||
2673|003|Z|information does not assure that this product is safe, effective,||
2673|004|Z|or appropriate for you. This information is not individual||
2673|005|Z|medical advice and does not substitute for the advice of your||
2673|006|Z|health care professional. Always ask your health care||
2673|007|Z|professional for complete information about this product and your||
2673|008|Z|specific health needs.||
2673|009|B|||
2673|010|T|GARADACIMAB - INJECTION||
2673|011|B|||
2673|012|C|COMMON BRAND NAME(S): Andembry||
2673|013|B|||
2673|014|U|USES:  This medication is used to help prevent severe swelling||
2673|015|U|attacks due to a certain inherited immune disease (hereditary||
2673|016|U|angioedema-HAE). Garadacimab belongs to a class of drugs known as||
2673|017|U|monoclonal antibodies. It works by blocking the effect of a||
2673|018|U|natural protein made by the body (activated Factor XII). This||
2673|019|U|effect lowers the amount of another natural substance||
2673|020|U|(bradykinin) that causes symptoms during an HAE attack.||
2673|021|B|||
2673|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
2673|023|H|Instructions for Use if available from your pharmacist before you||
2673|024|H|start using garadacimab and each time you get a refill. If you||
2673|025|H|have any questions, ask your doctor or pharmacist.||
2673|026|H|   Inject this medication under the skin as directed by your||
2673|027|H|doctor, usually once a month. The injection is given in the upper||
2673|028|H|arms, thighs, or abdomen (except for a 2-inch area around your||
2673|029|H|belly button).||
2673|030|H|   For a more comfortable injection, take the medication out of||
2673|031|H|the refrigerator at least 30 minutes before you inject it to||
2673|032|H|allow it to reach room temperature. Do not warm up this||
2673|033|H|medication any other way (for example, do not heat it in the||
2673|034|H|microwave, place it in hot water, or leave it in direct||
2673|035|H|sunlight). Do not shake the medication. Before using, check this||
2673|036|H|product for particles or discoloration. If either is present, do||
2673|037|H|not use the liquid. Before injecting each dose, clean the skin||
2673|038|H|you are going to inject into (the injection site) with rubbing||
2673|039|H|alcohol. Change the injection site each time to lessen injury||
2673|040|H|under the skin. Do not inject into skin that is tender, bruised,||
2673|041|H|red, hard, or damaged or into moles or scars. To lessen bruising,||
2673|042|H|do not rub the injection site after a shot. Learn how to store||
2673|043|H|and discard medical supplies safely.||
2673|044|H|   Use this medication regularly to get the most benefit from it.||
2673|045|H|To help you remember, mark your calendar with a reminder.||
2673|046|H|   Do not increase your dose or use this drug more often or for||
2673|047|H|longer than prescribed. Your condition will not improve any||
2673|048|H|faster, and your risk of side effects will increase.||
2673|049|H|   Tell your doctor if your condition does not get better or if||
2673|050|H|it gets worse.||
2673|051|B|||
2673|052|S|SIDE EFFECTS:  Redness, itching, or bruising at the injection||
2673|053|S|site may occur. Runny/stuffy nose or abdominal pain may also||
2673|054|S|occur. If any of these effects last or get worse, tell your||
2673|055|S|doctor or pharmacist promptly.||
2673|056|S|   Remember that this medication has been prescribed because your||
2673|057|S|doctor has judged that the benefit to you is greater than the||
2673|058|S|risk of side effects. Many people using this medication do not||
2673|059|S|have serious side effects.||
2673|060|S|   A very serious allergic reaction to this drug is rare.||
2673|061|S|However, get medical help right away if you notice any symptoms||
2673|062|S|of a serious allergic reaction, including: rash, itching/swelling||
2673|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2673|064|S|breathing.||
2673|065|S|   This is not a complete list of possible side effects. If you||
2673|066|S|notice other effects not listed above, contact your doctor or||
2673|067|S|pharmacist.||
2673|068|S|   In the US -||
2673|069|S|   Call your doctor for medical advice about side effects. You||
2673|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2673|071|S|www.fda.gov/medwatch.||
2673|072|S|   In Canada - Call your doctor for medical advice about side||
2673|073|S|effects. You may report side effects to Health Canada at||
2673|074|S|1-866-234-2345.||
2673|075|B|||
2673|076|P|PRECAUTIONS:  Before using garadacimab, tell your doctor or||
2673|077|P|pharmacist if you are allergic to it; or if you have any other||
2673|078|P|allergies. This product may contain inactive ingredients, which||
2673|079|P|can cause allergic reactions or other problems. Talk to your||
2673|080|P|pharmacist for more details.||
2673|081|P|   Before using this medication, tell your doctor or pharmacist||
2673|082|P|your medical history.||
2673|083|P|   Before having surgery, tell your doctor or dentist about all||
2673|084|P|the products you use (including prescription drugs,||
2673|085|P|nonprescription drugs, and herbal products).||
2673|086|P|   During pregnancy, this medication should be used only when||
2673|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
2673|088|P|   It is unknown if this medication passes into breast milk.||
2673|089|P|Consult your doctor before breastfeeding.||
2673|090|B|||
2673|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2673|092|I|medications work or increase your risk for serious side effects.||
2673|093|I|This document does not contain all possible drug interactions.||
2673|094|I|Keep a list of all the products you use (including||
2673|095|I|prescription/nonprescription drugs and herbal products) and share||
2673|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
2673|097|I|the dosage of any medicines without your doctor's approval.||
2673|098|I|   This medication may interfere with certain lab tests (such as||
2673|099|I|aPTT tests), possibly causing false test results. Make sure lab||
2673|100|I|personnel and all your doctors know you use this drug.||
2673|101|B|||
2673|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2673|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2673|104|O|poison control center right away. US residents can call||
2673|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2673|106|B|||
2673|107|N|NOTES:  Do not share this medication with others.||
2673|108|N|   Keep all medical and lab appointments.||
2673|109|B|||
2673|110|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2673|111|D|If it is near the time of the next dose, skip the missed dose.||
2673|112|D|Use your next dose at the regular time. Do not double the dose to||
2673|113|D|catch up.||
2673|114|B|||
2673|115|R|STORAGE:  Store in the refrigerator. Do not freeze. Do not use||
2673|116|R|this medication if it has been frozen. Keep the medication in the||
2673|117|R|original carton to protect from light. If the medication has been||
2673|118|R|allowed to reach room temperature, use it right away and do not||
2673|119|R|put it back in the refrigerator. Keep all medications away from||
2673|120|R|children and pets.||
2673|121|R|   Do not flush medications down the toilet or pour them into a||
2673|122|R|drain unless instructed to do so. Properly discard this product||
2673|123|R|when it is expired or no longer needed. Consult your pharmacist||
2673|124|R|or local waste disposal company.||
2673|125|B|||
2673|126|A|Information last revised July 2025.||
2673|127|A|Copyright(c) 2025 First Databank, Inc.||
2673|128|B|||
2674|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2674|002|Z|does NOT have all possible information about this product. This||
2674|003|Z|information does not assure that this product is safe, effective,||
2674|004|Z|or appropriate for you. This information is not individual||
2674|005|Z|medical advice and does not substitute for the advice of your||
2674|006|Z|health care professional. Always ask your health care||
2674|007|Z|professional for complete information about this product and your||
2674|008|Z|specific health needs.||
2674|009|B|||
2674|010|T|ACOLTREMON - OPHTHALMIC||
2674|011|B|||
2674|012|C|COMMON BRAND NAME(S): Tryptyr||
2674|013|B|||
2674|014|U|USES:  This medication is used to treat dry eye disease.||
2674|015|U|Acoltremon may work by increasing the amount of tears you make.||
2674|016|B|||
2674|017|H|HOW TO USE:  Read the Instructions for Use if available from your||
2674|018|H|pharmacist before you start using acoltremon and each time you||
2674|019|H|get a refill. If you have any questions, ask your doctor or||
2674|020|H|pharmacist.||
2674|021|H|   Use this medication in the affected eye(s) as directed by your||
2674|022|H|doctor, usually twice a day (about 12 hours apart).||
2674|023|H|   To apply eye drops, wash hands first. To avoid contamination,||
2674|024|H|do not touch the dropper tip or let it touch your eye or any||
2674|025|H|other surface.||
2674|026|H|   If you are wearing contact lenses, remove them before using||
2674|027|H|eye drops. Wait at least 15 minutes before replacing your contact||
2674|028|H|lenses. Tilt your head back, look upward, and pull down the lower||
2674|029|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2674|030|H|and place one drop into the pouch. Look downward, gently close||
2674|031|H|your eyes, and place one finger at the corner of your eye (near||
2674|032|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2674|033|H|opening your eyes. This will prevent the medication from draining||
2674|034|H|out. Try not to blink or rub your eye. If a drop misses your eye,||
2674|035|H|try again. If directed to use this medication in both eyes,||
2674|036|H|repeat these steps for your other eye. Throw away the opened||
2674|037|H|single-use vial after use. Do not save for later use.||
2674|038|H|   If you are using another kind of eye medication (such as drops||
2674|039|H|or ointments), wait at least 5 minutes before applying other||
2674|040|H|medications. Use eye drops before eye ointments to allow the||
2674|041|H|drops to enter the eye.||
2674|042|H|   Wait several minutes for your vision to clear before driving||
2674|043|H|or operating machinery.||
2674|044|H|   Use this medication regularly to get the most benefit from it.||
2674|045|H|To help you remember, use it at the same times each day.||
2674|046|H|   Tell your doctor if your condition lasts or gets worse.||
2674|047|B|||
2674|048|S|SIDE EFFECTS:  Eye discomfort, stinging, or burning may occur. If||
2674|049|S|any of these effects last or get worse, tell your doctor or||
2674|050|S|pharmacist promptly.||
2674|051|S|   Remember that this medication has been prescribed because your||
2674|052|S|doctor has judged that the benefit to you is greater than the||
2674|053|S|risk of side effects. Many people using this medication do not||
2674|054|S|have serious side effects.||
2674|055|S|   A very serious allergic reaction to this drug is rare.||
2674|056|S|However, get medical help right away if you notice any symptoms||
2674|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2674|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2674|059|S|breathing.||
2674|060|S|   This is not a complete list of possible side effects. If you||
2674|061|S|notice other effects not listed above, contact your doctor or||
2674|062|S|pharmacist.||
2674|063|S|   In the US -||
2674|064|S|   Call your doctor for medical advice about side effects. You||
2674|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2674|066|S|www.fda.gov/medwatch.||
2674|067|S|   In Canada - Call your doctor for medical advice about side||
2674|068|S|effects. You may report side effects to Health Canada at||
2674|069|S|1-866-234-2345.||
2674|070|B|||
2674|071|P|PRECAUTIONS:  Before using acoltremon, tell your doctor or||
2674|072|P|pharmacist if you are allergic to it; or if you have any other||
2674|073|P|allergies. This product may contain inactive ingredients, which||
2674|074|P|can cause allergic reactions or other problems. Talk to your||
2674|075|P|pharmacist for more details.||
2674|076|P|   Before using this medication, tell your doctor or pharmacist||
2674|077|P|your medical history.||
2674|078|P|   After you apply this drug, your vision may become temporarily||
2674|079|P|blurred. Do not drive, use machinery, or do anything that needs||
2674|080|P|clear vision until you can do it safely.||
2674|081|P|   Before having surgery, tell your doctor or dentist about all||
2674|082|P|the products you use (including prescription drugs,||
2674|083|P|nonprescription drugs, and herbal products).||
2674|084|P|   During pregnancy, this medication should be used only when||
2674|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
2674|086|P|   It is unknown if this drug passes into breast milk. Consult||
2674|087|P|your doctor before breastfeeding.||
2674|088|B|||
2674|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2674|090|I|medications work or increase your risk for serious side effects.||
2674|091|I|This document does not contain all possible drug interactions.||
2674|092|I|Keep a list of all the products you use (including||
2674|093|I|prescription/nonprescription drugs and herbal products) and share||
2674|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
2674|095|I|the dosage of any medicines without your doctor's approval.||
2674|096|B|||
2674|097|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2674|098|O|has overdosed and has serious symptoms such as passing out or||
2674|099|O|trouble breathing, call 911. Otherwise, call a poison control||
2674|100|O|center right away. US residents can call 1-800-222-1222. Canada||
2674|101|O|residents can call 1-844-764-7669.||
2674|102|B|||
2674|103|N|NOTES:  Do not share this medication with others.||
2674|104|B|||
2674|105|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
2674|106|D|next dose at the regular time. Do not double the dose to catch||
2674|107|D|up.||
2674|108|B|||
2674|109|R|STORAGE:  This medication comes in single-use vials, which are||
2674|110|R|stored in a foil pouch inside a carton. Store the unopened carton||
2674|111|R|in the refrigerator. Do not freeze. Once a carton has been||
2674|112|R|opened, it may be stored in the refrigerator or, if necessary, at||
2674|113|R|room temperature. If an opened carton is stored at room||
2674|114|R|temperature, discard after 30 days. Keep the single-use vials in||
2674|115|R|the foil pouch until ready to use. Once the foil pouch is opened,||
2674|116|R|the single-use vials inside expire after 7 days. Keep all||
2674|117|R|medications away from children and pets.||
2674|118|R|   Do not flush medications down the toilet or pour them into a||
2674|119|R|drain unless instructed to do so. Properly discard this product||
2674|120|R|when it is expired or no longer needed. Consult your pharmacist||
2674|121|R|or local waste disposal company.||
2674|122|B|||
2674|123|A|Information last revised July 2025.||
2674|124|A|Copyright(c) 2025 First Databank, Inc.||
2674|125|B|||
2675|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2675|002|Z|does NOT have all possible information about this product. This||
2675|003|Z|information does not assure that this product is safe, effective,||
2675|004|Z|or appropriate for you. This information is not individual||
2675|005|Z|medical advice and does not substitute for the advice of your||
2675|006|Z|health care professional. Always ask your health care||
2675|007|Z|professional for complete information about this product and your||
2675|008|Z|specific health needs.||
2675|009|B|||
2675|010|T|LINVOSELTAMAB - INJECTION||
2675|011|F|(LIN-voe-SEL-ta-mab)||
2675|012|B|||
2675|013|C|COMMON BRAND NAME(S): Lynozyfic||
2675|014|B|||
2675|015|W|WARNING:  Linvoseltamab may cause a certain serious (even fatal)||
2675|016|W|side effect known as cytokine release syndrome-CRS. Careful||
2675|017|W|monitoring and prompt treatment may decrease your risk. Tell your||
2675|018|W|doctor right away if you develop symptoms such as fever, chills,||
2675|019|W|fast heartbeat, trouble breathing, or dizziness/lightheadedness.||
2675|020|W|   This medication can also cause serious (even fatal) nervous||
2675|021|W|system problems. Tell your doctor right away if you have any||
2675|022|W|symptoms such as headache, confusion, trouble staying awake,||
2675|023|W|changes in your handwriting, shaking, loss of balance, trouble||
2675|024|W|speaking/walking, numbness/tingling, seizures, or||
2675|025|W|burning/throbbing/stabbing pain.||
2675|026|W|   To receive linvoseltamab in the United States, you must||
2675|027|W|understand, agree to, and carefully follow the requirements of||
2675|028|W|the REMS Program for this medication. If you live in Canada or||
2675|029|W|any other country, consult your doctor and pharmacist for your||
2675|030|W|country's regulations.||
2675|031|B|||
2675|032|U|USES:  This medication is used to treat a certain type of cancer||
2675|033|U|(multiple myeloma). Linvoseltamab works by slowing or stopping||
2675|034|U|the growth of cancer cells.||
2675|035|B|||
2675|036|H|HOW TO USE:  Read the Medication Guide provided by your||
2675|037|H|pharmacist before you start using linvoseltamab and each time you||
2675|038|H|get a treatment. If you have any questions, ask your doctor or||
2675|039|H|pharmacist. Carry the Patient Wallet Card with you at all times.||
2675|040|H|Show the card to all of your health care providers to let them||
2675|041|H|know that you are being treated with linvoseltamab.||
2675|042|H|   This medication is given by injection into a vein by a health||
2675|043|H|care professional. To reduce your risk of side effects, your||
2675|044|H|doctor will start this medication at a low dose and gradually||
2675|045|H|increase your dose. These starting doses are part of a "step-up||
2675|046|H|dosing schedule." You must stay in the hospital for 24 hours||
2675|047|H|after your first and second "step-up" doses so your doctor can||
2675|048|H|monitor you closely and help you manage any side effects. The||
2675|049|H|treatment schedule is based on your medical condition and||
2675|050|H|response to treatment.||
2675|051|H|   Before you receive this medication, your doctor will prescribe||
2675|052|H|other medications (such as acetaminophen, dexamethasone,||
2675|053|H|diphenhydramine) to help prevent side effects. Your doctor may||
2675|054|H|also prescribe other medications (such as antibiotics,||
2675|055|H|antivirals) to help prevent infection. Carefully follow your||
2675|056|H|doctor's directions for all your medications.||
2675|057|B|||
2675|058|S|SIDE EFFECTS:  See also Warning section.||
2675|059|S|   Tiredness, muscle/joint pain, nausea/vomiting, decreased||
2675|060|S|appetite, constipation, or diarrhea may occur. If any of these||
2675|061|S|effects last or get worse, tell your doctor or pharmacist||
2675|062|S|promptly.||
2675|063|S|   People using this medication may have serious side effects.||
2675|064|S|However, you have been prescribed this drug because your doctor||
2675|065|S|has judged that the benefit to you is greater than the risk of||
2675|066|S|side effects. Careful monitoring by your doctor may decrease your||
2675|067|S|risk.||
2675|068|S|   Tell your doctor right away if you have any serious side||
2675|069|S|effects, including: easy bruising/bleeding, signs of liver||
2675|070|S|disease (such as nausea/vomiting that doesn't stop,||
2675|071|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2675|072|S|of anemia (such as unusual tiredness, pale skin).||
2675|073|S|   This medication may lower your ability to fight infections.||
2675|074|S|This may make you more likely to get a serious (rarely fatal)||
2675|075|S|infection or make any infection you have worse. Tell your doctor||
2675|076|S|right away if you have any signs of infection (such as sore||
2675|077|S|throat that doesn't go away, fever, chills).||
2675|078|S|   Linvoseltamab can commonly cause a rash that is usually not||
2675|079|S|serious. However, you may not be able to tell it apart from a||
2675|080|S|rare rash that could be a sign of a severe reaction. Tell your||
2675|081|S|doctor right away if you develop any rash.||
2675|082|S|   A very serious allergic reaction to this drug is rare.||
2675|083|S|However, get medical help right away if you notice any symptoms||
2675|084|S|of a serious allergic reaction, including: rash, itching/swelling||
2675|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2675|086|S|breathing.||
2675|087|S|   This is not a complete list of possible side effects. If you||
2675|088|S|notice other effects not listed above, contact your doctor or||
2675|089|S|pharmacist.||
2675|090|S|   In the US -||
2675|091|S|   Call your doctor for medical advice about side effects. You||
2675|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2675|093|S|www.fda.gov/medwatch.||
2675|094|S|   In Canada - Call your doctor for medical advice about side||
2675|095|S|effects. You may report side effects to Health Canada at||
2675|096|S|1-866-234-2345.||
2675|097|B|||
2675|098|P|PRECAUTIONS:  Before using linvoseltamab, tell your doctor or||
2675|099|P|pharmacist if you are allergic to it; or if you have any other||
2675|100|P|allergies. This product may contain inactive ingredients, which||
2675|101|P|can cause allergic reactions or other problems. Talk to your||
2675|102|P|pharmacist for more details.||
2675|103|P|   Before using this medication, tell your doctor or pharmacist||
2675|104|P|your medical history, especially of: current/recent infections.||
2675|105|P|   This drug may make you dizzy or affect your thinking and||
2675|106|P|coordination. Alcohol or marijuana (cannabis) can worsen these||
2675|107|P|effects. Do not drive, use machinery, or do anything that needs||
2675|108|P|alertness for 48 hours after the first two "step-up" doses. At||
2675|109|P|all other times while using this medication, do not drive, use||
2675|110|P|machinery, or do anything that needs alertness until you can do||
2675|111|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2675|112|P|are using marijuana (cannabis).||
2675|113|P|   This medication can make you more likely to get infections or||
2675|114|P|may make current infections worse. Stay away from anyone who has||
2675|115|P|an infection that may easily spread (such as chickenpox,||
2675|116|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2675|117|P|exposed to an infection or for more details.||
2675|118|P|   Tell your health care professional that you are using||
2675|119|P|linvoseltamab before having any immunizations/vaccinations. Avoid||
2675|120|P|contact with people who have recently received live vaccines||
2675|121|P|(such as flu vaccine inhaled through the nose).||
2675|122|P|   To lower the chance of getting cut, bruised, or injured, use||
2675|123|P|caution with sharp objects like razors and nail cutters, and||
2675|124|P|avoid activities such as contact sports.||
2675|125|P|   Before having surgery, tell your doctor or dentist about all||
2675|126|P|the products you use (including prescription drugs,||
2675|127|P|nonprescription drugs, and herbal products).||
2675|128|P|   Tell your doctor if you are pregnant or plan to become||
2675|129|P|pregnant. You should not become pregnant while using||
2675|130|P|linvoseltamab. Linvoseltamab may harm an unborn baby. Your doctor||
2675|131|P|should order a pregnancy test before you start this medication.||
2675|132|P|Ask about reliable forms of birth control while using this||
2675|133|P|medication and for 3 months after the last dose. If you become||
2675|134|P|pregnant, talk to your doctor right away about the risks and||
2675|135|P|benefits of this medication.||
2675|136|P|   It is unknown if this drug passes into breast milk. Because of||
2675|137|P|the possible risk to the infant, breastfeeding is not recommended||
2675|138|P|while using this drug and for 3 months after the last dose.||
2675|139|P|Consult your doctor before breastfeeding.||
2675|140|B|||
2675|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2675|142|I|medications work or increase your risk for serious side effects.||
2675|143|I|This document does not contain all possible drug interactions.||
2675|144|I|Keep a list of all the products you use (including||
2675|145|I|prescription/nonprescription drugs and herbal products) and share||
2675|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
2675|147|I|the dosage of any medicines without your doctor's approval.||
2675|148|B|||
2675|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2675|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2675|151|O|poison control center right away. US residents can call||
2675|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2675|153|B|||
2675|154|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
2675|155|N|liver function) should be done before you start using this||
2675|156|N|medication and while you are using it. Keep all medical and lab||
2675|157|N|appointments. Consult your doctor for more details.||
2675|158|B|||
2675|159|D|MISSED DOSE:  It is important to get each dose of this medication||
2675|160|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2675|161|D|right away for a new dosing schedule.||
2675|162|B|||
2675|163|R|STORAGE:  Not applicable. This medication is given in a hospital||
2675|164|R|or clinic and will not be stored at home.||
2675|165|B|||
2675|166|M|MEDICAL ALERT:  Your condition can cause complications in a||
2675|167|M|medical emergency. For information about enrolling in MedicAlert,||
2675|168|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2675|169|B|||
2675|170|A|Information last revised July 2025.||
2675|171|A|Copyright(c) 2025 First Databank, Inc.||
2675|172|B|||
2676|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2676|002|Z|does NOT have all possible information about this product. This||
2676|003|Z|information does not assure that this product is safe, effective,||
2676|004|Z|or appropriate for you. This information is not individual||
2676|005|Z|medical advice and does not substitute for the advice of your||
2676|006|Z|health care professional. Always ask your health care||
2676|007|Z|professional for complete information about this product and your||
2676|008|Z|specific health needs.||
2676|009|B|||
2676|010|T|SEBETRALSTAT - ORAL||
2676|011|F|(SE-be-TRAL-stat)||
2676|012|B|||
2676|013|C|COMMON BRAND NAME(S): Ekterly||
2676|014|B|||
2676|015|U|USES:  This medication is used to treat attacks of sudden severe||
2676|016|U|swelling due to a certain inherited immune disease (hereditary||
2676|017|U|angioedema-HAE). Sebetralstat works by binding to a natural||
2676|018|U|substance made by the body (kallikrein) and blocking its effect.||
2676|019|U|This effect lowers the amount of another natural substance||
2676|020|U|(bradykinin) that causes symptoms during a sudden HAE attack.||
2676|021|B|||
2676|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2676|023|H|from your pharmacist before you start taking sebetralstat and||
2676|024|H|each time you get a refill. If you have any questions, ask your||
2676|025|H|doctor or pharmacist.||
2676|026|H|   Take this medication by mouth with or without food as directed||
2676|027|H|by your doctor, at the first signs of an HAE attack. The dosage||
2676|028|H|is based on your medical condition and other medications you may||
2676|029|H|be taking. Be sure to tell your doctor and pharmacist about all||
2676|030|H|the products you use (including prescription drugs,||
2676|031|H|nonprescription drugs, and herbal products).||
2676|032|H|   If your symptoms only partly get better, or if they get worse||
2676|033|H|or come back, you may take another dose at least 3 hours after||
2676|034|H|the first dose. Do not take more than 1,200 milligrams in a||
2676|035|H|24-hour period. Some patients may be directed to not take more||
2676|036|H|than 600 milligrams in a 24-hour period. Follow your doctor's||
2676|037|H|instructions carefully.||
2676|038|H|   Tell your doctor if your condition does not get better or if||
2676|039|H|it gets worse.||
2676|040|B|||
2676|041|S|SIDE EFFECTS:  Headache may occur. If this effect lasts or gets||
2676|042|S|worse, tell your doctor or pharmacist promptly.||
2676|043|S|   Remember that this medication has been prescribed because your||
2676|044|S|doctor has judged that the benefit to you is greater than the||
2676|045|S|risk of side effects. Many people using this medication do not||
2676|046|S|have serious side effects.||
2676|047|S|   A very serious allergic reaction to this drug is rare.||
2676|048|S|However, get medical help right away if you notice any symptoms||
2676|049|S|of a serious allergic reaction, including: rash, itching/swelling||
2676|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2676|051|S|breathing.||
2676|052|S|   This is not a complete list of possible side effects. If you||
2676|053|S|notice other effects not listed above, contact your doctor or||
2676|054|S|pharmacist.||
2676|055|S|   In the US -||
2676|056|S|   Call your doctor for medical advice about side effects. You||
2676|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2676|058|S|www.fda.gov/medwatch.||
2676|059|S|   In Canada - Call your doctor for medical advice about side||
2676|060|S|effects. You may report side effects to Health Canada at||
2676|061|S|1-866-234-2345.||
2676|062|B|||
2676|063|P|PRECAUTIONS:  Before taking sebetralstat, tell your doctor or||
2676|064|P|pharmacist if you are allergic to it; or if you have any other||
2676|065|P|allergies. This product may contain inactive ingredients, which||
2676|066|P|can cause allergic reactions or other problems. Talk to your||
2676|067|P|pharmacist for more details.||
2676|068|P|   Before using this medication, tell your doctor or pharmacist||
2676|069|P|your medical history, especially of: liver disease.||
2676|070|P|   Before having surgery, tell your doctor or dentist about all||
2676|071|P|the products you use (including prescription drugs,||
2676|072|P|nonprescription drugs, and herbal products).||
2676|073|P|   During pregnancy, this medication should be used only when||
2676|074|P|clearly needed. Discuss the risks and benefits with your doctor.||
2676|075|P|   It is unknown if this medication passes into breast milk.||
2676|076|P|Consult your doctor before breastfeeding.||
2676|077|B|||
2676|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2676|079|I|medications work or increase your risk for serious side effects.||
2676|080|I|This document does not contain all possible drug interactions.||
2676|081|I|Keep a list of all the products you use (including||
2676|082|I|prescription/nonprescription drugs and herbal products) and share||
2676|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
2676|084|I|the dosage of any medicines without your doctor's approval.||
2676|085|I|   Other medications can affect the removal of sebetralstat from||
2676|086|I|your body, which may affect how sebetralstat works. Examples||
2676|087|I|include efavirenz, itraconazole, phenytoin, among others.||
2676|088|B|||
2676|089|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2676|090|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2676|091|O|poison control center right away. US residents can call||
2676|092|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2676|093|B|||
2676|094|N|NOTES:  Do not share this medication with others.||
2676|095|N|   Keep all medical and lab appointments.||
2676|096|B|||
2676|097|D|MISSED DOSE:  Not applicable.||
2676|098|B|||
2676|099|R|STORAGE:  Store at room temperature away from light and moisture.||
2676|100|R|Do not store in the bathroom. Keep all medications away from||
2676|101|R|children and pets.||
2676|102|R|   Do not flush medications down the toilet or pour them into a||
2676|103|R|drain unless instructed to do so. Properly discard this product||
2676|104|R|when it is expired or no longer needed. Consult your pharmacist||
2676|105|R|or local waste disposal company.||
2676|106|B|||
2676|107|A|Information last revised July 2025.||
2676|108|A|Copyright(c) 2025 First Databank, Inc.||
2676|109|B|||
2677|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2677|002|Z|does NOT have all possible information about this product. This||
2677|003|Z|information does not assure that this product is safe, effective,||
2677|004|Z|or appropriate for you. This information is not individual||
2677|005|Z|medical advice and does not substitute for the advice of your||
2677|006|Z|health care professional. Always ask your health care||
2677|007|Z|professional for complete information about this product and your||
2677|008|Z|specific health needs.||
2677|009|B|||
2677|010|T|DELGOCITINIB - TOPICAL||
2677|011|F|(DEL-goe-SYE-ti-nib)||
2677|012|B|||
2677|013|C|COMMON BRAND NAME(S): Anzupgo||
2677|014|B|||
2677|015|U|USES:  This medication is used to treat chronic hand eczema.||
2677|016|U|Eczema is an allergic-type condition that causes red, irritated,||
2677|017|U|and itchy skin. Delgocitinib works by weakening the skin's||
2677|018|U|defense (immune) system, which can help relieve symptoms of||
2677|019|U|eczema on the hand. It belongs to a class of drugs known as||
2677|020|U|kinase inhibitors.||
2677|021|B|||
2677|022|H|HOW TO USE:  Read the Medication Guide provided by your||
2677|023|H|pharmacist before you start using delgocitinib and each time you||
2677|024|H|get a refill. If you have any questions, ask your doctor or||
2677|025|H|pharmacist.||
2677|026|H|   Wash and dry your hands before applying the medication, then||
2677|027|H|clean and dry the affected area. Apply a thin film to the||
2677|028|H|affected areas of hand and wrist as directed by your doctor,||
2677|029|H|usually twice daily.||
2677|030|H|   This medication is for use on the skin only. Avoid getting||
2677|031|H|this medication in your eyes or on the inside of your nose or||
2677|032|H|mouth. If you do get the medication in those areas, flush with||
2677|033|H|plenty of water.||
2677|034|H|   Use this medication exactly as directed. Do not use more than||
2677|035|H|30 grams of this medication per 2 weeks or 60 grams per month||
2677|036|H|unless directed to do so by your doctor.||
2677|037|H|   Tell your doctor if your condition lasts or gets worse.||
2677|038|B|||
2677|039|S|SIDE EFFECTS:  Pain or tingling may occur at the application||
2677|040|S|site. If either of these effects lasts or gets worse, tell your||
2677|041|S|doctor or pharmacist promptly.||
2677|042|S|   Remember that this medication has been prescribed because your||
2677|043|S|doctor has judged that the benefit to you is greater than the||
2677|044|S|risk of side effects. Many people using this medication do not||
2677|045|S|have serious side effects.||
2677|046|S|   This medication may lower your ability to fight infections.||
2677|047|S|This may make you more likely to get a serious (rarely fatal)||
2677|048|S|infection or make any infection you have worse. People taking||
2677|049|S|similar medications by mouth or on the skin have had very serious||
2677|050|S|(possibly fatal) infections (such as fungal infections,||
2677|051|S|tuberculosis, herpes zoster). Tell your doctor right away if you||
2677|052|S|have any signs of infection (such as a sore throat that doesn't||
2677|053|S|go away, cough that doesn't go away, fever, chills, unusual||
2677|054|S|sweating, painful skin rash/blisters).||
2677|055|S|   This medication may rarely cause new skin cancers. Your doctor||
2677|056|S|should do regular skin exams during treatment. Check your skin||
2677|057|S|and tell your doctor right away if you notice skin changes such||
2677|058|S|as a new wart, skin sore/bump that bleeds or does not heal,||
2677|059|S|change in size or color of a mole.||
2677|060|S|   Another medication similar to delgocitinib usually taken by||
2677|061|S|mouth has caused serious (possibly fatal) side effects, including||
2677|062|S|heart problems and blood clots. Before using delgocitinib, tell||
2677|063|S|your doctor or pharmacist if you have a history of heart disease,||
2677|064|S|or stroke, or if you have any risk factors for heart disease||
2677|065|S|(such as high blood pressure, diabetes, previous blood clots,||
2677|066|S|high cholesterol, smoking or history of smoking). Discuss the||
2677|067|S|risks and benefits of treatment with your doctor.||
2677|068|S|   A very serious allergic reaction to this drug is rare.||
2677|069|S|However, get medical help right away if you notice any symptoms||
2677|070|S|of a serious allergic reaction, including: rash, itching/swelling||
2677|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2677|072|S|breathing.||
2677|073|S|   This is not a complete list of possible side effects. If you||
2677|074|S|notice other effects not listed above, contact your doctor or||
2677|075|S|pharmacist.||
2677|076|S|   In the US -||
2677|077|S|   Call your doctor for medical advice about side effects. You||
2677|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2677|079|S|www.fda.gov/medwatch.||
2677|080|S|   In Canada - Call your doctor for medical advice about side||
2677|081|S|effects. You may report side effects to Health Canada at||
2677|082|S|1-866-234-2345.||
2677|083|B|||
2677|084|P|PRECAUTIONS:  See also Side Effects section.||
2677|085|P|   Before using delgocitinib, tell your doctor or pharmacist if||
2677|086|P|you are allergic to it; or if you have any other allergies. This||
2677|087|P|product may contain inactive ingredients, which can cause||
2677|088|P|allergic reactions or other problems. Talk to your pharmacist for||
2677|089|P|more details.||
2677|090|P|   Before using this medication, tell your doctor or pharmacist||
2677|091|P|your medical history, especially of: cancer (such as skin||
2677|092|P|cancer), current/past/returning infections (such as tuberculosis,||
2677|093|P|hepatitis B and C).||
2677|094|P|   Delgocitinib can make you more likely to get infections or may||
2677|095|P|make current infections worse. Stay away from anyone who has an||
2677|096|P|infection that may easily spread (such as chickenpox, COVID-19,||
2677|097|P|measles, flu). Talk to your doctor if you have been exposed to an||
2677|098|P|infection or for more details.||
2677|099|P|   Tell your health care professional that you are using||
2677|100|P|delgocitinib before having any immunizations/vaccinations. Avoid||
2677|101|P|contact with people who have recently received live vaccines||
2677|102|P|(such as flu vaccine inhaled through the nose).||
2677|103|P|   Before having surgery, tell your doctor or dentist about all||
2677|104|P|the products you use (including prescription drugs,||
2677|105|P|nonprescription drugs, and herbal products).||
2677|106|P|   This medication may increase your risk of getting skin cancer.||
2677|107|P|Limit your time in the sun. Avoid tanning booths and sunlamps.||
2677|108|P|Use sunscreen and wear protective clothing when outdoors.||
2677|109|P|   During pregnancy, this medication should be used only when||
2677|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
2677|111|P|   It is unknown if this medication passes into breast milk.||
2677|112|P|Consult your doctor before breastfeeding.||
2677|113|B|||
2677|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2677|115|I|medications work or increase your risk for serious side effects.||
2677|116|I|This document does not contain all possible drug interactions.||
2677|117|I|Keep a list of all the products you use (including||
2677|118|I|prescription/nonprescription drugs and herbal products) and share||
2677|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
2677|120|I|the dosage of any medicines without your doctor's approval.||
2677|121|B|||
2677|122|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2677|123|O|has overdosed and has serious symptoms such as passing out or||
2677|124|O|trouble breathing, call 911. Otherwise, call a poison control||
2677|125|O|center right away. US residents can call 1-800-222-1222. Canada||
2677|126|O|residents can call 1-844-764-7669.||
2677|127|B|||
2677|128|N|NOTES:  Do not share this medication with others.||
2677|129|N|   Lab and/or medical tests (such as complete blood counts,||
2677|130|N|cholesterol/triglyceride levels, skin exams) may be done while||
2677|131|N|you are using this medication. Keep all medical and lab||
2677|132|N|appointments. Consult your doctor for more details.||
2677|133|N|   This medication has been prescribed for your current condition||
2677|134|N|only. Do not use it later for another skin condition unless your||
2677|135|N|doctor tells you to.||
2677|136|N|   Talk with your doctor about other ways to manage your eczema,||
2677|137|N|such as using moisturizers and taking shorter baths/showers.||
2677|138|B|||
2677|139|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2677|140|D|If it is near the time of the next dose, skip the missed dose.||
2677|141|D|Use your next dose at the regular time. Do not double the dose to||
2677|142|D|catch up.||
2677|143|B|||
2677|144|R|STORAGE:  Different brands of this medication have different||
2677|145|R|storage needs. Check the product package for instructions on how||
2677|146|R|to store your brand, or ask your pharmacist. Keep all medications||
2677|147|R|away from children and pets.||
2677|148|R|   Do not flush medications down the toilet or pour them into a||
2677|149|R|drain unless instructed to do so. Properly discard this product||
2677|150|R|when it is expired or no longer needed. Consult your pharmacist||
2677|151|R|or local waste disposal company.||
2677|152|B|||
2677|153|A|Information last revised August 2025.||
2677|154|A|Copyright(c) 2025 First Databank, Inc.||
2677|155|B|||
2678|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2678|002|Z|does NOT have all possible information about this product. This||
2678|003|Z|information does not assure that this product is safe, effective,||
2678|004|Z|or appropriate for you. This information is not individual||
2678|005|Z|medical advice and does not substitute for the advice of your||
2678|006|Z|health care professional. Always ask your health care||
2678|007|Z|professional for complete information about this product and your||
2678|008|Z|specific health needs.||
2678|009|B|||
2678|010|T|GYMNEMA (Gymnema sylvestre) - ORAL||
2678|011|B|||
2678|012|U|USES:  Gymnema has been used for diabetes. Before using any||
2678|013|U|herbal product, talk to your doctor or pharmacist about your||
2678|014|U|medical condition.||
2678|015|U|   Some supplement products have been found to contain possibly||
2678|016|U|harmful impurities/additives. Check with your pharmacist for more||
2678|017|U|details about the brand you use.||
2678|018|U|   The FDA has not reviewed this product for safety or||
2678|019|U|effectiveness. Consult your doctor or pharmacist for more||
2678|020|U|details.||
2678|021|B|||
2678|022|H|HOW TO USE:  Follow all directions on the product package. If||
2678|023|H|your doctor has prescribed this product, take it as directed. If||
2678|024|H|you have any questions, ask your doctor or pharmacist.||
2678|025|H|   Tell your doctor if your condition lasts or gets worse. If you||
2678|026|H|think you may have a serious medical problem, get medical help||
2678|027|H|right away.||
2678|028|B|||
2678|029|S|SIDE EFFECTS:  A very serious allergic reaction to this product||
2678|030|S|is rare. However, get medical help right away if you notice any||
2678|031|S|symptoms of a serious allergic reaction, including: rash,||
2678|032|S|itching/swelling (especially of the face/tongue/throat), severe||
2678|033|S|dizziness, trouble breathing.||
2678|034|S|   This is not a complete list of possible side effects. If you||
2678|035|S|notice other effects not listed above, contact your doctor or||
2678|036|S|pharmacist.||
2678|037|S|   In the US -||
2678|038|S|   Call your doctor for medical advice about side effects. You||
2678|039|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2678|040|S|www.fda.gov/medwatch.||
2678|041|S|   In Canada - Call your doctor for medical advice about side||
2678|042|S|effects. You may report side effects to Health Canada at||
2678|043|S|1-866-234-2345.||
2678|044|B|||
2678|045|P|PRECAUTIONS:  Before taking gymnema, tell your doctor or||
2678|046|P|pharmacist if you are allergic to it; or if you have any other||
2678|047|P|allergies. This product may contain inactive ingredients, which||
2678|048|P|can cause allergic reactions or other problems. Talk to your||
2678|049|P|pharmacist for more details.||
2678|050|P|   If you have any health problems, consult your doctor or||
2678|051|P|pharmacist before using this product.||
2678|052|P|   Before having surgery, tell your doctor or dentist about all||
2678|053|P|the products you use (including prescription drugs,||
2678|054|P|nonprescription drugs, and herbal products).||
2678|055|P|   During pregnancy, this product should be used only when||
2678|056|P|clearly needed. Discuss the risks and benefits with your doctor.||
2678|057|P|   It is unknown if this product passes into breast milk. Consult||
2678|058|P|your doctor before breastfeeding.||
2678|059|B|||
2678|060|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2678|061|I|medications work or increase your risk for serious side effects.||
2678|062|I|This document does not contain all possible drug interactions.||
2678|063|I|Keep a list of all the products you use (including||
2678|064|I|prescription/nonprescription drugs and herbal products) and share||
2678|065|I|it with your doctor and pharmacist. Do not start, stop, or change||
2678|066|I|the dosage of any medicines without your doctor's approval.||
2678|067|B|||
2678|068|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2678|069|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2678|070|O|poison control center right away. US residents can call||
2678|071|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2678|072|B|||
2678|073|N|NOTES:  Keep all medical and lab appointments.||
2678|074|B|||
2678|075|D|MISSED DOSE:  If you are taking this product on a regular||
2678|076|D|schedule and miss a dose, take it as soon as you remember. If it||
2678|077|D|is near the time of the next dose, skip the missed dose. Take||
2678|078|D|your next dose at the regular time. Do not double the dose to||
2678|079|D|catch up.||
2678|080|B|||
2678|081|R|STORAGE:  Refer to storage information printed on the package. If||
2678|082|R|you have any questions about storage, ask your pharmacist. Keep||
2678|083|R|all medications and herbal products away from children and pets.||
2678|084|R|   Do not flush medications down the toilet or pour them into a||
2678|085|R|drain unless instructed to do so. Properly discard this product||
2678|086|R|when it is expired or no longer needed. Consult your pharmacist||
2678|087|R|or local waste disposal company.||
2678|088|B|||
2678|089|A|Information last revised August 2025.||
2678|090|A|Copyright(c) 2025 First Databank, Inc.||
2678|091|B|||
2679|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2679|002|Z|does NOT have all possible information about this product. This||
2679|003|Z|information does not assure that this product is safe, effective,||
2679|004|Z|or appropriate for you. This information is not individual||
2679|005|Z|medical advice and does not substitute for the advice of your||
2679|006|Z|health care professional. Always ask your health care||
2679|007|Z|professional for complete information about this product and your||
2679|008|Z|specific health needs.||
2679|009|B|||
2679|010|T|ACECLIDINE - OPHTHALMIC||
2679|011|F|(a-SEK-li-deen)||
2679|012|B|||
2679|013|C|COMMON BRAND NAME(S): Vizz||
2679|014|B|||
2679|015|U|USES:  This medication is used to treat age-related||
2679|016|U|farsightedness (presbyopia). Aceclidine works by causing the||
2679|017|U|pupil of the eye to shrink, which may help with seeing things up||
2679|018|U|close.||
2679|019|B|||
2679|020|H|HOW TO USE:  Use this medication in the affected eye(s) as||
2679|021|H|directed by your doctor, usually once daily.||
2679|022|H|   To apply eye drops, wash hands first. To avoid contamination,||
2679|023|H|do not touch the dropper tip or let it touch your eye or any||
2679|024|H|other surface.||
2679|025|H|   If you are wearing contact lenses, remove them before using||
2679|026|H|eye drops. Wait at least 10 minutes before replacing your contact||
2679|027|H|lenses.||
2679|028|H|   Tilt your head back, look upward, and pull down the lower||
2679|029|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2679|030|H|and place one drop into the pouch. Look downward, gently close||
2679|031|H|your eyes, and place one finger at the corner of your eye (near||
2679|032|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2679|033|H|opening your eyes. This will prevent the medication from draining||
2679|034|H|out. Try not to blink or rub your eye. Repeat these steps if your||
2679|035|H|dose is for more than one drop. If directed to use this||
2679|036|H|medication in both eyes, repeat these steps for your other eye.||
2679|037|H|Do not rinse the dropper. Throw away the opened single-dose vial||
2679|038|H|after use.||
2679|039|H|   If you are using another kind of eye medication (such as drops||
2679|040|H|or ointments), wait at least 5 minutes before applying other||
2679|041|H|medications. Use eye drops before eye ointments to allow the||
2679|042|H|drops to enter the eye.||
2679|043|H|   Wait several minutes for your vision to clear before driving||
2679|044|H|or operating machinery.||
2679|045|H|   Use this medication regularly to get the most benefit from it.||
2679|046|H|To help you remember, use it at the same time each day.||
2679|047|H|   Tell your doctor if your condition lasts or gets worse.||
2679|048|B|||
2679|049|S|SIDE EFFECTS:  Temporary irritation of the eye, eye redness,||
2679|050|S|temporary blurred vision, poor vision in dim light, or headache||
2679|051|S|may occur. If any of these effects last or get worse, tell your||
2679|052|S|doctor or pharmacist promptly.||
2679|053|S|   Remember that this medication has been prescribed because your||
2679|054|S|doctor has judged that the benefit to you is greater than the||
2679|055|S|risk of side effects. Many people using this medication do not||
2679|056|S|have serious side effects.||
2679|057|S|   Tell your doctor right away if you have any serious side||
2679|058|S|effects, including: eye pain, vision changes (such as seeing||
2679|059|S|floaters/flashes of light).||
2679|060|S|   A very serious allergic reaction to this drug is rare.||
2679|061|S|However, get medical help right away if you notice any symptoms||
2679|062|S|of a serious allergic reaction, including: rash, itching/swelling||
2679|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2679|064|S|breathing.||
2679|065|S|   This is not a complete list of possible side effects. If you||
2679|066|S|notice other effects not listed above, contact your doctor or||
2679|067|S|pharmacist.||
2679|068|S|   In the US -||
2679|069|S|   Call your doctor for medical advice about side effects. You||
2679|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2679|071|S|www.fda.gov/medwatch.||
2679|072|S|   In Canada - Call your doctor for medical advice about side||
2679|073|S|effects. You may report side effects to Health Canada at||
2679|074|S|1-866-234-2345.||
2679|075|B|||
2679|076|P|PRECAUTIONS:  Before using aceclidine, tell your doctor or||
2679|077|P|pharmacist if you are allergic to it; or if you have any other||
2679|078|P|allergies. This product may contain inactive ingredients, which||
2679|079|P|can cause allergic reactions or other problems. Talk to your||
2679|080|P|pharmacist for more details.||
2679|081|P|   Before using this medication, tell your doctor or pharmacist||
2679|082|P|your medical history, especially of: other eye problems (such as||
2679|083|P|iritis, detached retina).||
2679|084|P|   After you apply this drug, your vision may become temporarily||
2679|085|P|blurred or unstable. Vision in dim light may be affected. Do not||
2679|086|P|drive (especially at night), use machinery, or do anything that||
2679|087|P|needs clear vision until you can do it safely.||
2679|088|P|   Before having surgery, tell your doctor or dentist about all||
2679|089|P|the products you use (including prescription drugs,||
2679|090|P|nonprescription drugs, and herbal products).||
2679|091|P|   During pregnancy, this medication should be used only when||
2679|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
2679|093|P|   It is unknown if this drug passes into breast milk. Consult||
2679|094|P|your doctor before breastfeeding.||
2679|095|B|||
2679|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2679|097|I|medications work or increase your risk for serious side effects.||
2679|098|I|This document does not contain all possible drug interactions.||
2679|099|I|Keep a list of all the products you use (including||
2679|100|I|prescription/nonprescription drugs and herbal products) and share||
2679|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
2679|102|I|the dosage of any medicines without your doctor's approval.||
2679|103|B|||
2679|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2679|105|O|has overdosed and has serious symptoms such as passing out or||
2679|106|O|trouble breathing, call 911. Otherwise, call a poison control||
2679|107|O|center right away. US residents can call 1-800-222-1222. Canada||
2679|108|O|residents can call 1-844-764-7669. Symptoms of overdose may||
2679|109|O|include: increased saliva or sweating, nausea, tremors, slow||
2679|110|O|heartbeat, dizziness.||
2679|111|B|||
2679|112|N|NOTES:  Do not share this medication with others.||
2679|113|N|   Lab and/or medical tests (such as eye exams) may be done while||
2679|114|N|you are using this medication. Keep all medical and lab||
2679|115|N|appointments. Consult your doctor for more details.||
2679|116|B|||
2679|117|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2679|118|D|If it is near the time of the next dose, skip the missed dose.||
2679|119|D|Use your next dose at the regular time. Do not double the dose to||
2679|120|D|catch up.||
2679|121|B|||
2679|122|R|STORAGE:  Store in the refrigerator. Do not freeze. This||
2679|123|R|medication may also be stored at room temperature if needed. If||
2679|124|R|the medication is stored at room temperature, discard after 30||
2679|125|R|days. Keep all medications away from children and pets.||
2679|126|R|   Do not flush medications down the toilet or pour them into a||
2679|127|R|drain unless instructed to do so. Properly discard this product||
2679|128|R|when it is expired or no longer needed. Consult your pharmacist||
2679|129|R|or local waste disposal company.||
2679|130|B|||
2679|131|A|Information last revised August 2025.||
2679|132|A|Copyright(c) 2025 First Databank, Inc.||
2679|133|B|||
2680|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2680|002|Z|does NOT have all possible information about this product. This||
2680|003|Z|information does not assure that this product is safe, effective,||
2680|004|Z|or appropriate for you. This information is not individual||
2680|005|Z|medical advice and does not substitute for the advice of your||
2680|006|Z|health care professional. Always ask your health care||
2680|007|Z|professional for complete information about this product and your||
2680|008|Z|specific health needs.||
2680|009|B|||
2680|010|T|SEPIAPTERIN - ORAL||
2680|011|F|(SE-pi-AP-ter-in)||
2680|012|B|||
2680|013|C|COMMON BRAND NAME(S): Sephience||
2680|014|B|||
2680|015|U|USES:  This medication is used along with diet changes for||
2680|016|U|long-term treatment of a certain inherited disorder||
2680|017|U|(phenylketonuria-PKU). It helps remove a certain chemical||
2680|018|U|(phenylalanine) from the body. Too much phenylalanine in the body||
2680|019|U|can cause brain damage.||
2680|020|B|||
2680|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2680|022|H|Instructions for Use if available from your pharmacist before you||
2680|023|H|start taking sepiapterin and each time you get a refill. If you||
2680|024|H|have any questions, ask your doctor or pharmacist.||
2680|025|H|   Take this medication by mouth with food as directed by your||
2680|026|H|doctor, usually once daily. After taking this medication, eat||
2680|027|H|some more food.||
2680|028|H|   Mix the contents of the packet with water or apple juice as||
2680|029|H|directed. Certain doses may also be mixed in strawberry jam or||
2680|030|H|applesauce. Ask your doctor or pharmacist how to mix and prepare||
2680|031|H|your dose. Mix well and carefully measure the dose using a||
2680|032|H|special measuring device/spoon. Do not use a household spoon||
2680|033|H|because you may not get the correct dose. After mixing, the||
2680|034|H|medication should be taken within 6 hours if stored at room||
2680|035|H|temperature or within 24 hours if stored in the refrigerator.||
2680|036|H|Discard any unused medication after 6 hours at room temperature||
2680|037|H|or 24 hours in the refrigerator.||
2680|038|H|   The dosage is based on your medical condition, response to||
2680|039|H|treatment, age, weight, and lab tests.||
2680|040|H|   To reduce your risk of side effects, your doctor may direct||
2680|041|H|you to start this medication at a low dose and gradually increase||
2680|042|H|your dose. Follow your doctor's instructions carefully.||
2680|043|H|   Use this medication regularly to get the most benefit from it.||
2680|044|H|To help you remember, take it at the same time each day.||
2680|045|H|   Do not increase your dose or use this drug more often or for||
2680|046|H|longer than prescribed. Your condition will not improve any||
2680|047|H|faster, and your risk of side effects will increase.||
2680|048|H|   Tell your doctor if you do not get better or if you get worse.||
2680|049|B|||
2680|050|S|SIDE EFFECTS:  Diarrhea, abdominal pain, or headache may occur.||
2680|051|S|If any of these effects last or get worse, tell your doctor or||
2680|052|S|pharmacist promptly.||
2680|053|S|   This medication may cause your stool to turn yellow or orange.||
2680|054|S|This effect is harmless and will disappear when the medication is||
2680|055|S|stopped.||
2680|056|S|   Remember that this medication has been prescribed because your||
2680|057|S|doctor has judged that the benefit to you is greater than the||
2680|058|S|risk of side effects. Many people using this medication do not||
2680|059|S|have serious side effects.||
2680|060|S|   Tell your doctor right away if you have any serious side||
2680|061|S|effects, including: easy bleeding/bruising, heavy menstrual||
2680|062|S|bleeding.||
2680|063|S|   A very serious allergic reaction to this drug is rare.||
2680|064|S|However, get medical help right away if you notice any symptoms||
2680|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2680|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2680|067|S|breathing.||
2680|068|S|   This is not a complete list of possible side effects. If you||
2680|069|S|notice other effects not listed above, contact your doctor or||
2680|070|S|pharmacist.||
2680|071|S|   In the US -||
2680|072|S|   Call your doctor for medical advice about side effects. You||
2680|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2680|074|S|www.fda.gov/medwatch.||
2680|075|S|   In Canada - Call your doctor for medical advice about side||
2680|076|S|effects. You may report side effects to Health Canada at||
2680|077|S|1-866-234-2345.||
2680|078|B|||
2680|079|P|PRECAUTIONS:  Before taking sepiapterin, tell your doctor or||
2680|080|P|pharmacist if you are allergic to it; or if you have any other||
2680|081|P|allergies. This product may contain inactive ingredients, which||
2680|082|P|can cause allergic reactions or other problems. Talk to your||
2680|083|P|pharmacist for more details.||
2680|084|P|   Before using this medication, tell your doctor or pharmacist||
2680|085|P|your medical history.||
2680|086|P|   Before having surgery, tell your doctor or dentist about all||
2680|087|P|the products you use (including prescription drugs,||
2680|088|P|nonprescription drugs, and herbal products).||
2680|089|P|   During pregnancy, this medication should be used only when||
2680|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
2680|091|P|   It is unknown if this medication passes into breast milk.||
2680|092|P|Consult your doctor before breastfeeding.||
2680|093|B|||
2680|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2680|095|I|medications work or increase your risk for serious side effects.||
2680|096|I|This document does not contain all possible drug interactions.||
2680|097|I|Keep a list of all the products you use (including||
2680|098|I|prescription/nonprescription drugs and herbal products) and share||
2680|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
2680|100|I|the dosage of any medicines without your doctor's approval.||
2680|101|B|||
2680|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2680|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2680|104|O|poison control center right away. US residents can call||
2680|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2680|106|B|||
2680|107|N|NOTES:  Do not share this medication with others.||
2680|108|N|   Lab and/or medical tests (such as phenylalanine blood levels)||
2680|109|N|should be done before you start taking this medication and while||
2680|110|N|you are taking it. Keep all medical and lab appointments. Consult||
2680|111|N|your doctor for more details.||
2680|112|B|||
2680|113|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
2680|114|D|if it is on the same day. If you do not remember until the next||
2680|115|D|day, skip the missed dose. Take your next dose at the regular||
2680|116|D|time. Do not double the dose to catch up.||
2680|117|B|||
2680|118|R|STORAGE:  Store at room temperature away from light and moisture.||
2680|119|R|Do not store in the bathroom. Keep all medications away from||
2680|120|R|children and pets.||
2680|121|R|   Do not flush medications down the toilet or pour them into a||
2680|122|R|drain unless instructed to do so. Properly discard this product||
2680|123|R|when it is expired or no longer needed. Consult your pharmacist||
2680|124|R|or local waste disposal company.||
2680|125|B|||
2680|126|A|Information last revised August 2025.||
2680|127|A|Copyright(c) 2025 First Databank, Inc.||
2680|128|B|||
2681|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2681|002|Z|does NOT have all possible information about this product. This||
2681|003|Z|information does not assure that this product is safe, effective,||
2681|004|Z|or appropriate for you. This information is not individual||
2681|005|Z|medical advice and does not substitute for the advice of your||
2681|006|Z|health care professional. Always ask your health care||
2681|007|Z|professional for complete information about this product and your||
2681|008|Z|specific health needs.||
2681|009|B|||
2681|010|T|DORDAVIPRONE - ORAL||
2681|011|B|||
2681|012|C|COMMON BRAND NAME(S): Modeyso||
2681|013|B|||
2681|014|U|USES:  This medication is used to treat a certain type of brain||
2681|015|U|tumor (diffuse midline glioma). It works by slowing or stopping||
2681|016|U|the growth of tumor cells.||
2681|017|B|||
2681|018|H|HOW TO USE:  Read the Patient Information Leaflet and||
2681|019|H|Instructions for Use if available from your pharmacist before you||
2681|020|H|start taking dordaviprone and each time you get a refill. If you||
2681|021|H|have any questions, ask your doctor or pharmacist.||
2681|022|H|   Take this medication by mouth on an empty stomach (at least 1||
2681|023|H|hour before or 3 hours after eating food) as directed by your||
2681|024|H|doctor, usually once a week.||
2681|025|H|   Swallow the capsules whole. If you have trouble swallowing the||
2681|026|H|capsules, you may open the capsule and mix the contents with 1 to||
2681|027|H|2 tablespoons (15 to 30 milliliters) of water, apple juice,||
2681|028|H|lemonade, or sports drink. Stir gently and drink all of the||
2681|029|H|mixture within 2 hours of mixing.||
2681|030|H|   If you are giving this medication through a feeding tube, ask||
2681|031|H|your health care professional for detailed instructions on how to||
2681|032|H|properly mix and give it.||
2681|033|H|   The dosage is based on your medical condition, response to||
2681|034|H|treatment, and other medications you may be taking. Be sure to||
2681|035|H|tell your doctor and pharmacist about all the products you use||
2681|036|H|(including prescription drugs, nonprescription drugs, and herbal||
2681|037|H|products). Children's dosage is also based on weight.||
2681|038|H|   If you vomit after taking a dose, do not take another dose.||
2681|039|H|Take your next dose at the regular time. Do not double the dose||
2681|040|H|to catch up.||
2681|041|H|   Take this medication regularly to get the most benefit from||
2681|042|H|it. To help you remember, take it on the same day each week. Mark||
2681|043|H|your calendar with a reminder.||
2681|044|H|   Do not increase your dose or use this drug more often or for||
2681|045|H|longer than prescribed. Your condition will not improve any||
2681|046|H|faster, and your risk of serious side effects will increase.||
2681|047|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2681|048|H|using this medication unless your doctor or pharmacist says you||
2681|049|H|may do so safely. Grapefruit can increase the chance of side||
2681|050|H|effects with this medicine. Ask your doctor or pharmacist for||
2681|051|H|more details.||
2681|052|H|   Since this drug can be absorbed through the skin and lungs and||
2681|053|H|may harm an unborn baby, women who are pregnant or who may become||
2681|054|H|pregnant should not handle this medication or breathe the dust||
2681|055|H|from the capsules.||
2681|056|B|||
2681|057|S|SIDE EFFECTS:  Nausea, vomiting, tiredness, dizziness, headache,||
2681|058|S|or muscle/joint pain may occur. If any of these effects last or||
2681|059|S|get worse, tell your doctor or pharmacist promptly.||
2681|060|S|   Remember that this medication has been prescribed because your||
2681|061|S|doctor has judged that the benefit to you is greater than the||
2681|062|S|risk of side effects. Many people using this medication do not||
2681|063|S|have serious side effects.||
2681|064|S|   Get medical help right away if you have any very serious side||
2681|065|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2681|066|S|fainting.||
2681|067|S|   A very serious allergic reaction to this drug is rare.||
2681|068|S|However, get medical help right away if you notice any symptoms||
2681|069|S|of a serious allergic reaction, including: fever, rash,||
2681|070|S|itching/swelling (especially of the face/tongue/throat), severe||
2681|071|S|dizziness, trouble breathing.||
2681|072|S|   This is not a complete list of possible side effects. If you||
2681|073|S|notice other effects not listed above, contact your doctor or||
2681|074|S|pharmacist.||
2681|075|S|   In the US -||
2681|076|S|   Call your doctor for medical advice about side effects. You||
2681|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2681|078|S|www.fda.gov/medwatch.||
2681|079|S|   In Canada - Call your doctor for medical advice about side||
2681|080|S|effects. You may report side effects to Health Canada at||
2681|081|S|1-866-234-2345.||
2681|082|B|||
2681|083|P|PRECAUTIONS:  Before taking dordaviprone, tell your doctor or||
2681|084|P|pharmacist if you are allergic to it; or if you have any other||
2681|085|P|allergies. This product may contain inactive ingredients, which||
2681|086|P|can cause allergic reactions or other problems. Talk to your||
2681|087|P|pharmacist for more details.||
2681|088|P|   Before using this medication, tell your doctor or pharmacist||
2681|089|P|your medical history.||
2681|090|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2681|091|P|can make you more dizzy. Do not drive, use machinery, or do||
2681|092|P|anything that needs alertness until you can do it safely. Limit||
2681|093|P|alcoholic beverages. Talk to your doctor if you are using||
2681|094|P|marijuana (cannabis).||
2681|095|P|   Dordaviprone may cause a condition that affects the heart||
2681|096|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2681|097|P|serious (rarely fatal) fast/irregular heartbeat and other||
2681|098|P|symptoms (such as severe dizziness, fainting) that need medical||
2681|099|P|attention right away.||
2681|100|P|   The risk of QT prolongation may be increased if you have||
2681|101|P|certain medical conditions or are taking other drugs that may||
2681|102|P|cause QT prolongation. Before using dordaviprone, tell your||
2681|103|P|doctor or pharmacist of all the drugs you take and if you have||
2681|104|P|any of the following conditions: certain heart problems (heart||
2681|105|P|failure, slow heartbeat, QT prolongation in the EKG), family||
2681|106|P|history of certain heart problems (QT prolongation in the EKG,||
2681|107|P|sudden cardiac death).||
2681|108|P|   Low levels of potassium or magnesium in the blood may also||
2681|109|P|increase your risk of QT prolongation. This risk may increase if||
2681|110|P|you use certain drugs (such as diuretics/"water pills") or if you||
2681|111|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2681|112|P|Talk to your doctor about using dordaviprone safely.||
2681|113|P|   Before having surgery, tell your doctor or dentist about all||
2681|114|P|the products you use (including prescription drugs,||
2681|115|P|nonprescription drugs, and herbal products).||
2681|116|P|   Older adults may be more sensitive to the side effects of this||
2681|117|P|drug, especially QT prolongation (see above).||
2681|118|P|   Since this drug can be absorbed through the skin and lungs and||
2681|119|P|may harm an unborn baby, women who are pregnant or who may become||
2681|120|P|pregnant should not handle this medication or breathe the dust||
2681|121|P|from the capsules.||
2681|122|P|   Tell your doctor if you are pregnant or plan to become||
2681|123|P|pregnant. You should not become pregnant while using||
2681|124|P|dordaviprone. Dordaviprone may harm an unborn baby. Your doctor||
2681|125|P|should order a pregnancy test before you start this medication.||
2681|126|P|Men and women using this medication should ask about reliable||
2681|127|P|forms of birth control during treatment and for 1 month after the||
2681|128|P|last dose. If you or your partner becomes pregnant, talk to your||
2681|129|P|doctor right away about the risks and benefits of this||
2681|130|P|medication.||
2681|131|P|   It is unknown if this medication passes into breast milk.||
2681|132|P|Because of the possible risk to the infant, breastfeeding is not||
2681|133|P|recommended while using this medication and for 1 week after the||
2681|134|P|last dose. Consult your doctor before breastfeeding.||
2681|135|B|||
2681|136|I|DRUG INTERACTIONS:  See also How to Use section.||
2681|137|I|   Drug interactions may change how your medications work or||
2681|138|I|increase your risk for serious side effects. This document does||
2681|139|I|not contain all possible drug interactions. Keep a list of all||
2681|140|I|the products you use (including prescription/nonprescription||
2681|141|I|drugs and herbal products) and share it with your doctor and||
2681|142|I|pharmacist. Do not start, stop, or change the dosage of any||
2681|143|I|medicines without your doctor's approval.||
2681|144|B|||
2681|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2681|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2681|147|O|poison control center right away. US residents can call||
2681|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2681|149|B|||
2681|150|N|NOTES:  Do not share this medication with others.||
2681|151|N|   Lab and/or medical tests (such as EKG, blood mineral levels)||
2681|152|N|should be done before you start taking this medication and while||
2681|153|N|you are taking it. Keep all medical and lab appointments. Consult||
2681|154|N|your doctor for more details.||
2681|155|B|||
2681|156|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2681|157|D|remember. If it is more than 2 days after the missed dose, skip||
2681|158|D|the missed dose. Take your next dose at the regular time. Do not||
2681|159|D|double the dose to catch up.||
2681|160|B|||
2681|161|R|STORAGE:  Store at room temperature away from light and moisture.||
2681|162|R|Do not store in the bathroom. Keep all medications away from||
2681|163|R|children and pets.||
2681|164|R|   Do not flush medications down the toilet or pour them into a||
2681|165|R|drain unless instructed to do so. Properly discard this product||
2681|166|R|when it is expired or no longer needed. Consult your pharmacist||
2681|167|R|or local waste disposal company.||
2681|168|B|||
2681|169|A|Information last revised August 2025.||
2681|170|A|Copyright(c) 2025 First Databank, Inc.||
2681|171|B|||
2682|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2682|002|Z|does NOT have all possible information about this product. This||
2682|003|Z|information does not assure that this product is safe, effective,||
2682|004|Z|or appropriate for you. This information is not individual||
2682|005|Z|medical advice and does not substitute for the advice of your||
2682|006|Z|health care professional. Always ask your health care||
2682|007|Z|professional for complete information about this product and your||
2682|008|Z|specific health needs.||
2682|009|B|||
2682|010|T|SULOPENEM/PROBENECID - ORAL||
2682|011|F|(SUL-oh-PEN-em/proe-BEN-e-sid)||
2682|012|B|||
2682|013|C|COMMON BRAND NAME(S): Orlynvah||
2682|014|B|||
2682|015|U|USES:  This product is used to treat bladder infections (urinary||
2682|016|U|tract infections) in women. It contains 2 different medications:||
2682|017|U|sulopenem and probenecid. Sulopenem is a penem-type antibiotic||
2682|018|U|that works by stopping the growth of bacteria. Probenecid is a||
2682|019|U|protein inhibitor (OAT3 inhibitor) that helps sulopenem work||
2682|020|U|better.||
2682|021|U|   This antibiotic treats only bacterial infections. It will not||
2682|022|U|work for viral infections (such as common cold, flu). Using any||
2682|023|U|antibiotic when it is not needed can cause it to not work for||
2682|024|U|future infections.||
2682|025|B|||
2682|026|H|HOW TO USE:  Take this medication by mouth with food as directed||
2682|027|H|by your doctor, usually twice a day.||
2682|028|H|   For the best effect, take this antibiotic at evenly spaced||
2682|029|H|times. To help you remember, take this medication at the same||
2682|030|H|times every day.||
2682|031|H|   Continue to take this medication until the full prescribed||
2682|032|H|amount is finished, even if symptoms disappear after a few days.||
2682|033|H|Stopping the medication too early may result in a return of the||
2682|034|H|infection.||
2682|035|H|   Tell your doctor if your condition lasts or gets worse.||
2682|036|B|||
2682|037|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, or headache may occur.||
2682|038|S|If any of these effects last or get worse, tell your doctor or||
2682|039|S|pharmacist promptly.||
2682|040|S|   Remember that this medication has been prescribed because your||
2682|041|S|doctor has judged that the benefit to you is greater than the||
2682|042|S|risk of side effects. Many people using this medication do not||
2682|043|S|have serious side effects.||
2682|044|S|   This medication may rarely cause a severe intestinal condition||
2682|045|S|due to a bacteria called C. difficile. This condition may occur||
2682|046|S|during treatment or weeks to months after treatment has stopped.||
2682|047|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2682|048|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2682|049|S|stool.||
2682|050|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2682|051|S|products because they may make symptoms worse.||
2682|052|S|   This medication may sometimes cause oral thrush or a new yeast||
2682|053|S|infection. Contact your doctor if you notice white patches in||
2682|054|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2682|055|S|   A very serious allergic reaction to this drug is rare.||
2682|056|S|However, get medical help right away if you notice any symptoms||
2682|057|S|of a serious allergic reaction, including: rash, itching/swelling||
2682|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2682|059|S|breathing.||
2682|060|S|   This is not a complete list of possible side effects. If you||
2682|061|S|notice other effects not listed above, contact your doctor or||
2682|062|S|pharmacist.||
2682|063|S|   In the US -||
2682|064|S|   Call your doctor for medical advice about side effects. You||
2682|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2682|066|S|www.fda.gov/medwatch.||
2682|067|S|   In Canada - Call your doctor for medical advice about side||
2682|068|S|effects. You may report side effects to Health Canada at||
2682|069|S|1-866-234-2345.||
2682|070|B|||
2682|071|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2682|072|P|pharmacist if you are allergic to sulopenem or probenecid; or to||
2682|073|P|related antibiotics (such as penicillins, cephalosporins,||
2682|074|P|carbapenems); or if you have any other allergies. This product||
2682|075|P|may contain inactive ingredients, which can cause allergic||
2682|076|P|reactions or other problems. Talk to your pharmacist for more||
2682|077|P|details.||
2682|078|P|   Before using this medication, tell your doctor or pharmacist||
2682|079|P|your medical history, especially of: kidney disease (such as||
2682|080|P|kidney stones), gout, blood disorders (such as anemia), a certain||
2682|081|P|enzyme deficiency (G6PD).||
2682|082|P|   Sulopenem may cause live bacterial vaccines (such as typhoid||
2682|083|P|vaccine) to not work well. Tell your health care professional||
2682|084|P|that you are using sulopenem before having any||
2682|085|P|immunizations/vaccinations.||
2682|086|P|   Before having surgery, tell your doctor or dentist about all||
2682|087|P|the products you use (including prescription drugs,||
2682|088|P|nonprescription drugs, and herbal products).||
2682|089|P|   During pregnancy, this medication should be used only when||
2682|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
2682|091|P|   It is unknown if sulopenem passes into breast milk. Probenecid||
2682|092|P|passes into breast milk. Consult your doctor before||
2682|093|P|breastfeeding.||
2682|094|B|||
2682|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2682|096|I|medications work or increase your risk for serious side effects.||
2682|097|I|This document does not contain all possible drug interactions.||
2682|098|I|Keep a list of all the products you use (including||
2682|099|I|prescription/nonprescription drugs and herbal products) and share||
2682|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
2682|101|I|the dosage of any medicines without your doctor's approval.||
2682|102|I|   This medication can slow down the removal of other medications||
2682|103|I|from your body, which may affect how they work. Examples of||
2682|104|I|affected drugs include irinotecan, ketoprofen, ketorolac,||
2682|105|I|methotrexate, pralatrexate, among others.||
2682|106|I|   This medication may interfere with certain lab tests (such as||
2682|107|I|urine glucose tests), possibly causing false test results. Make||
2682|108|I|sure lab personnel and all your doctors know you use this drug.||
2682|109|B|||
2682|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2682|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2682|112|O|poison control center right away. US residents can call||
2682|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2682|114|B|||
2682|115|N|NOTES:  Do not share this medication with others.||
2682|116|N|   This medication has been prescribed for your current condition||
2682|117|N|only. Do not use it later for another infection unless your||
2682|118|N|doctor tells you to.||
2682|119|B|||
2682|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2682|121|D|remember. If it is near the time of the next dose, skip the||
2682|122|D|missed dose. Take your next dose at the regular time. Do not||
2682|123|D|double the dose to catch up.||
2682|124|B|||
2682|125|R|STORAGE:  Store at room temperature away from light and moisture.||
2682|126|R|Do not store in the bathroom. Keep all medications away from||
2682|127|R|children and pets.||
2682|128|R|   Do not flush medications down the toilet or pour them into a||
2682|129|R|drain unless instructed to do so. Properly discard this product||
2682|130|R|when it is expired or no longer needed. Consult your pharmacist||
2682|131|R|or local waste disposal company.||
2682|132|B|||
2682|133|A|Information last revised August 2025.||
2682|134|A|Copyright(c) 2025 First Databank, Inc.||
2682|135|B|||
2683|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2683|002|Z|does NOT have all possible information about this product. This||
2683|003|Z|information does not assure that this product is safe, effective,||
2683|004|Z|or appropriate for you. This information is not individual||
2683|005|Z|medical advice and does not substitute for the advice of your||
2683|006|Z|health care professional. Always ask your health care||
2683|007|Z|professional for complete information about this product and your||
2683|008|Z|specific health needs.||
2683|009|B|||
2683|010|T|ZONGERTINIB - ORAL||
2683|011|B|||
2683|012|C|COMMON BRAND NAME(S): Hernexeos||
2683|013|B|||
2683|014|U|USES:  This medication is used to treat a certain type of lung||
2683|015|U|cancer (non-small cell lung cancer-NSCLC). Zongertinib works by||
2683|016|U|slowing or stopping the growth of cancer cells. It belongs to a||
2683|017|U|class of drugs known as kinase inhibitors.||
2683|018|B|||
2683|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2683|020|H|from your pharmacist before you start taking zongertinib and each||
2683|021|H|time you get a refill. If you have any questions, ask your doctor||
2683|022|H|or pharmacist.||
2683|023|H|   Take this medication by mouth with or without food as directed||
2683|024|H|by your doctor, usually once daily. Swallow the tablets whole||
2683|025|H|with water. Do not split, crush, or chew the tablets.||
2683|026|H|   The dosage is based on your medical condition, weight,||
2683|027|H|response to treatment, and other medications you may be taking.||
2683|028|H|Be sure to tell your doctor and pharmacist about all the products||
2683|029|H|you use (including prescription drugs, nonprescription drugs, and||
2683|030|H|herbal products).||
2683|031|H|   If you vomit after taking a dose, do not take another dose at||
2683|032|H|that time. Take your next dose at the regular time.||
2683|033|H|   Use this medication regularly to get the most benefit from it.||
2683|034|H|To help you remember, take it at the same time each day.||
2683|035|H|   Do not increase your dose or use this drug more often or for||
2683|036|H|longer than prescribed. Your condition will not improve any||
2683|037|H|faster, and your risk of serious side effects will increase.||
2683|038|H|   Since this drug can be absorbed through the skin and lungs and||
2683|039|H|may harm an unborn baby, women who are pregnant or who may become||
2683|040|H|pregnant should not handle this medication or breathe the dust||
2683|041|H|from the tablets.||
2683|042|B|||
2683|043|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, tiredness, or||
2683|044|S|muscle/joint pain may occur. If any of these effects last or get||
2683|045|S|worse, tell your doctor or pharmacist promptly.||
2683|046|S|   People using this medication may have serious side effects.||
2683|047|S|However, you have been prescribed this drug because your doctor||
2683|048|S|has judged that the benefit to you is greater than the risk of||
2683|049|S|side effects. Careful monitoring by your doctor may decrease your||
2683|050|S|risk.||
2683|051|S|   Diarrhea that doesn't stop may result in dehydration. Contact||
2683|052|S|your doctor promptly if you notice any symptoms of dehydration,||
2683|053|S|such as unusual decreased urination, unusual dry mouth/thirst,||
2683|054|S|fast heartbeat, or dizziness/lightheadedness.||
2683|055|S|   Tell your doctor right away if you have any serious side||
2683|056|S|effects, including: signs of heart problems (such as shortness of||
2683|057|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
2683|058|S|weight gain).||
2683|059|S|   Zongertinib may rarely cause serious (possibly fatal) liver||
2683|060|S|disease. Get medical help right away if you have any symptoms of||
2683|061|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
2683|062|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2683|063|S|urine.||
2683|064|S|   Although this medication is used to treat certain types of||
2683|065|S|lung cancer, it may rarely cause other serious (possibly fatal)||
2683|066|S|lung problems. Get medical help right away if you have any new or||
2683|067|S|worsening trouble breathing, chest pain, cough, or fever.||
2683|068|S|   Zongertinib can commonly cause a rash that is usually not||
2683|069|S|serious. However, you may not be able to tell it apart from a||
2683|070|S|rare rash that could be a sign of a severe reaction. Get medical||
2683|071|S|help right away if you develop any rash.||
2683|072|S|   A very serious allergic reaction to this drug is rare.||
2683|073|S|However, get medical help right away if you notice any symptoms||
2683|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2683|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2683|076|S|breathing.||
2683|077|S|   This is not a complete list of possible side effects. If you||
2683|078|S|notice other effects not listed above, contact your doctor or||
2683|079|S|pharmacist.||
2683|080|S|   In the US -||
2683|081|S|   Call your doctor for medical advice about side effects. You||
2683|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2683|083|S|www.fda.gov/medwatch.||
2683|084|S|   In Canada - Call your doctor for medical advice about side||
2683|085|S|effects. You may report side effects to Health Canada at||
2683|086|S|1-866-234-2345.||
2683|087|B|||
2683|088|P|PRECAUTIONS:  Before taking zongertinib, tell your doctor or||
2683|089|P|pharmacist if you are allergic to it; or if you have any other||
2683|090|P|allergies. This product may contain inactive ingredients, which||
2683|091|P|can cause allergic reactions or other problems. Talk to your||
2683|092|P|pharmacist for more details.||
2683|093|P|   Before using this medication, tell your doctor or pharmacist||
2683|094|P|your medical history, especially of: heart disease (such as heart||
2683|095|P|failure), liver disease, other lung/breathing problems.||
2683|096|P|   Before having surgery, tell your doctor or dentist about all||
2683|097|P|the products you use (including prescription drugs,||
2683|098|P|nonprescription drugs, and herbal products).||
2683|099|P|   Since this drug can be absorbed through the skin and lungs and||
2683|100|P|may harm an unborn baby, women who are pregnant or who may become||
2683|101|P|pregnant should not handle this medication or breathe the dust||
2683|102|P|from the tablets.||
2683|103|P|   Tell your doctor if you are pregnant or plan to become||
2683|104|P|pregnant. You should not become pregnant while using zongertinib.||
2683|105|P|Zongertinib may harm an unborn baby. Your doctor should order a||
2683|106|P|pregnancy test before you start this medication. Ask about||
2683|107|P|reliable forms of birth control while using this medication and||
2683|108|P|for 2 weeks after the last dose. If you become pregnant, talk to||
2683|109|P|your doctor right away about the risks and benefits of this||
2683|110|P|medication.||
2683|111|P|   It is unknown if this drug passes into breast milk. Because of||
2683|112|P|the possible risk to the infant, breastfeeding is not recommended||
2683|113|P|while using this drug and for 2 weeks after the last dose.||
2683|114|P|Consult your doctor before breastfeeding.||
2683|115|B|||
2683|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2683|117|I|medications work or increase your risk for serious side effects.||
2683|118|I|This document does not contain all possible drug interactions.||
2683|119|I|Keep a list of all the products you use (including||
2683|120|I|prescription/nonprescription drugs and herbal products) and share||
2683|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
2683|122|I|the dosage of any medicines without your doctor's approval.||
2683|123|B|||
2683|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2683|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2683|126|O|poison control center right away. US residents can call||
2683|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2683|128|B|||
2683|129|N|NOTES:  Do not share this medication with others.||
2683|130|N|   Lab and/or medical tests (such as liver/heart function) should||
2683|131|N|be done before you start taking this medication and while you are||
2683|132|N|taking it. Keep all medical and lab appointments. Consult your||
2683|133|N|doctor for more details.||
2683|134|B|||
2683|135|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2683|136|D|remember. If it is more than 12 hours after the missed dose, skip||
2683|137|D|the missed dose. Take your next dose at the regular time. Do not||
2683|138|D|double the dose to catch up.||
2683|139|B|||
2683|140|R|STORAGE:  Store in the original bottle at room temperature away||
2683|141|R|from light and moisture. Do not store in the bathroom. Keep the||
2683|142|R|drying agent (desiccant) in the bottle. Tightly close the bottle||
2683|143|R|when not in use. Once the bottle is opened, this medication||
2683|144|R|expires after 3 months. Keep all medications away from children||
2683|145|R|and pets.||
2683|146|R|   Do not flush medications down the toilet or pour them into a||
2683|147|R|drain unless instructed to do so. Properly discard this product||
2683|148|R|when it is expired or no longer needed. Consult your pharmacist||
2683|149|R|or local waste disposal company.||
2683|150|B|||
2683|151|A|Information last revised August 2025.||
2683|152|A|Copyright(c) 2025 First Databank, Inc.||
2683|153|B|||
2684|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2684|002|Z|does NOT have all possible information about this product. This||
2684|003|Z|information does not assure that this product is safe, effective,||
2684|004|Z|or appropriate for you. This information is not individual||
2684|005|Z|medical advice and does not substitute for the advice of your||
2684|006|Z|health care professional. Always ask your health care||
2684|007|Z|professional for complete information about this product and your||
2684|008|Z|specific health needs.||
2684|009|B|||
2684|010|T|BRENSOCATIB - ORAL||
2684|011|B|||
2684|012|C|COMMON BRAND NAME(S): Brinsupri||
2684|013|B|||
2684|014|U|USES:  This medication is used to treat a serious chronic lung||
2684|015|U|disease (non-cystic fibrosis bronchiectasis - NCFB). NCFB causes||
2684|016|U|swelling of the airways and frequent worsening of symptoms||
2684|017|U|(flare-ups) such as worsening cough, shortness of breath and||
2684|018|U|increased sputum. Brensocatib works by blocking certain enzymes||
2684|019|U|(neutrophil serine proteases). Blocking them helps reduce||
2684|020|U|swelling and the number of flare-ups.||
2684|021|B|||
2684|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2684|023|H|from your pharmacist before you start taking brensocatib and each||
2684|024|H|time you get a refill. If you have any questions, ask your doctor||
2684|025|H|or pharmacist.||
2684|026|H|   Take this medication by mouth with or without food as directed||
2684|027|H|by your doctor, usually once daily. The dosage is based on your||
2684|028|H|medical condition and response to treatment.||
2684|029|H|   Use this medication regularly to get the most benefit from it.||
2684|030|H|To help you remember, take it at the same time each day.||
2684|031|H|   Tell your doctor if you do not get better or if you get worse.||
2684|032|B|||
2684|033|S|SIDE EFFECTS:  Stuffy/runny nose, sore throat, fever, sneezing,||
2684|034|S|or headache may occur. If any of these effects last or get worse,||
2684|035|S|tell your doctor or pharmacist promptly.||
2684|036|S|   Remember that this medication has been prescribed because your||
2684|037|S|doctor has judged that the benefit to you is greater than the||
2684|038|S|risk of side effects. Many people using this medication do not||
2684|039|S|have serious side effects.||
2684|040|S|   Tell your doctor right away if you have any serious side||
2684|041|S|effects, including: skin problems (dry skin, thickening of skin),||
2684|042|S|tooth/gum pain.||
2684|043|S|   Brensocatib can commonly cause a rash that is usually not||
2684|044|S|serious. However, you may not be able to tell it apart from a||
2684|045|S|rare rash that could be a sign of a severe reaction. Tell your||
2684|046|S|doctor right away if you develop any rash.||
2684|047|S|   A very serious allergic reaction to this drug is rare.||
2684|048|S|However, get medical help right away if you notice any symptoms||
2684|049|S|of a serious allergic reaction, including: rash, itching/swelling||
2684|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2684|051|S|breathing.||
2684|052|S|   This is not a complete list of possible side effects. If you||
2684|053|S|notice other effects not listed above, contact your doctor or||
2684|054|S|pharmacist.||
2684|055|S|   In the US -||
2684|056|S|   Call your doctor for medical advice about side effects. You||
2684|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2684|058|S|www.fda.gov/medwatch.||
2684|059|S|   In Canada - Call your doctor for medical advice about side||
2684|060|S|effects. You may report side effects to Health Canada at||
2684|061|S|1-866-234-2345.||
2684|062|B|||
2684|063|P|PRECAUTIONS:  Before taking brensocatib, tell your doctor or||
2684|064|P|pharmacist if you are allergic to it; or if you have any other||
2684|065|P|allergies. This product may contain inactive ingredients, which||
2684|066|P|can cause allergic reactions or other problems. Talk to your||
2684|067|P|pharmacist for more details.||
2684|068|P|   Before using this medication, tell your doctor or pharmacist||
2684|069|P|your medical history.||
2684|070|P|   Brensocatib may cause live bacterial vaccines (such as typhoid||
2684|071|P|vaccine) to not work well. Tell your health care professional||
2684|072|P|that you are using brensocatib before having any||
2684|073|P|immunizations/vaccinations.||
2684|074|P|   Some people using this medication may have dental problems||
2684|075|P|(such as tooth/gum pain). To help prevent dental problems, have||
2684|076|P|regular dental exams and learn how to keep your teeth and gums||
2684|077|P|healthy. If you have tooth or gum pain, tell your doctor and||
2684|078|P|dentist right away.||
2684|079|P|   Before having surgery, tell your doctor or dentist about all||
2684|080|P|the products you use (including prescription drugs,||
2684|081|P|nonprescription drugs, and herbal products).||
2684|082|P|   During pregnancy, this medication should be used only when||
2684|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
2684|084|P|   It is unknown if this medication passes into breast milk.||
2684|085|P|Consult your doctor before breastfeeding.||
2684|086|B|||
2684|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2684|088|I|medications work or increase your risk for serious side effects.||
2684|089|I|This document does not contain all possible drug interactions.||
2684|090|I|Keep a list of all the products you use (including||
2684|091|I|prescription/nonprescription drugs and herbal products) and share||
2684|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
2684|093|I|the dosage of any medicines without your doctor's approval.||
2684|094|B|||
2684|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2684|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2684|097|O|poison control center right away. US residents can call||
2684|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2684|099|B|||
2684|100|N|NOTES:  Do not share this medication with others.||
2684|101|N|   Lab and/or medical tests (such as liver function) may be done||
2684|102|N|while you are taking this medication. Keep all medical and lab||
2684|103|N|appointments. Consult your doctor for more details.||
2684|104|B|||
2684|105|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2684|106|D|next dose at the regular time. Do not double the dose to catch||
2684|107|D|up.||
2684|108|B|||
2684|109|R|STORAGE:  Store in the original bottle at room temperature away||
2684|110|R|from light and moisture. Do not store in the bathroom. Keep all||
2684|111|R|medications away from children and pets.||
2684|112|R|   Do not flush medications down the toilet or pour them into a||
2684|113|R|drain unless instructed to do so. Properly discard this product||
2684|114|R|when it is expired or no longer needed. Consult your pharmacist||
2684|115|R|or local waste disposal company.||
2684|116|B|||
2684|117|A|Information last revised September 2025.||
2684|118|A|Copyright(c) 2025 First Databank, Inc.||
2684|119|B|||
2685|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2685|002|Z|does NOT have all possible information about this product. This||
2685|003|Z|information does not assure that this product is safe, effective,||
2685|004|Z|or appropriate for you. This information is not individual||
2685|005|Z|medical advice and does not substitute for the advice of your||
2685|006|Z|health care professional. Always ask your health care||
2685|007|Z|professional for complete information about this product and your||
2685|008|Z|specific health needs.||
2685|009|B|||
2685|010|T|GENISTEIN - ORAL||
2685|011|F|(JEN-i-steen)||
2685|012|B|||
2685|013|U|USES:  Genistein has been used for certain symptoms of menopause||
2685|014|U|(such as hot flashes). Before using any herbal product, talk to||
2685|015|U|your doctor or pharmacist about your medical condition.||
2685|016|U|   Some supplement products have been found to contain possibly||
2685|017|U|harmful impurities/additives. Check with your pharmacist for more||
2685|018|U|details about the brand you use.||
2685|019|U|   The FDA has not reviewed this product for safety or||
2685|020|U|effectiveness. Consult your doctor or pharmacist for more||
2685|021|U|details.||
2685|022|B|||
2685|023|H|HOW TO USE:  Follow all directions on the product package. If||
2685|024|H|your doctor has prescribed this product, take it as directed. If||
2685|025|H|you have any questions, ask your doctor or pharmacist.||
2685|026|H|   Tell your doctor if your condition lasts or gets worse. If you||
2685|027|H|think you may have a serious medical problem, get medical help||
2685|028|H|right away.||
2685|029|B|||
2685|030|S|SIDE EFFECTS:  Stomach upset or nausea may occur. If either of||
2685|031|S|these effects lasts or gets worse, tell your doctor or pharmacist||
2685|032|S|promptly.||
2685|033|S|   A very serious allergic reaction to this product is rare.||
2685|034|S|However, get medical help right away if you notice any symptoms||
2685|035|S|of a serious allergic reaction, including: rash, itching/swelling||
2685|036|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2685|037|S|breathing.||
2685|038|S|   This is not a complete list of possible side effects. If you||
2685|039|S|notice other effects not listed above, contact your doctor or||
2685|040|S|pharmacist.||
2685|041|S|   In the US -||
2685|042|S|   Call your doctor for medical advice about side effects. You||
2685|043|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2685|044|S|www.fda.gov/medwatch.||
2685|045|S|   In Canada - Call your doctor for medical advice about side||
2685|046|S|effects. You may report side effects to Health Canada at||
2685|047|S|1-866-234-2345.||
2685|048|B|||
2685|049|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
2685|050|P|pharmacist if you are allergic to it; or if you have any other||
2685|051|P|allergies. This product may contain inactive ingredients, which||
2685|052|P|can cause allergic reactions or other problems. Talk to your||
2685|053|P|pharmacist for more details.||
2685|054|P|   If you have any health problems, consult your doctor or||
2685|055|P|pharmacist before using this product.||
2685|056|P|   Before having surgery, tell your doctor or dentist about all||
2685|057|P|the products you use (including prescription drugs,||
2685|058|P|nonprescription drugs, and herbal products).||
2685|059|P|   During pregnancy, this product should be used only when||
2685|060|P|clearly needed. Discuss the risks and benefits with your doctor.||
2685|061|P|   It is unknown if this product passes into breast milk. Consult||
2685|062|P|your doctor before breastfeeding.||
2685|063|B|||
2685|064|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2685|065|I|medications work or increase your risk for serious side effects.||
2685|066|I|This document does not contain all possible drug interactions.||
2685|067|I|Keep a list of all the products you use (including||
2685|068|I|prescription/nonprescription drugs and herbal products) and share||
2685|069|I|it with your doctor and pharmacist. Do not start, stop, or change||
2685|070|I|the dosage of any medicines without your doctor's approval.||
2685|071|B|||
2685|072|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2685|073|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2685|074|O|poison control center right away. US residents can call||
2685|075|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2685|076|B|||
2685|077|N|NOTES:  Keep all medical and lab appointments.||
2685|078|B|||
2685|079|D|MISSED DOSE:  If you are taking this product on a regular||
2685|080|D|schedule and miss a dose, take it as soon as you remember. If it||
2685|081|D|is near the time of the next dose, skip the missed dose. Take||
2685|082|D|your next dose at the regular time. Do not double the dose to||
2685|083|D|catch up.||
2685|084|B|||
2685|085|R|STORAGE:  Refer to storage information printed on the package. If||
2685|086|R|you have any questions about storage, ask your pharmacist. Keep||
2685|087|R|all medications and herbal products away from children and pets.||
2685|088|R|   Do not flush medications down the toilet or pour them into a||
2685|089|R|drain unless instructed to do so. Properly discard this product||
2685|090|R|when it is expired or no longer needed. Consult your pharmacist||
2685|091|R|or local waste disposal company.||
2685|092|B|||
2685|093|A|Information last revised September 2025.||
2685|094|A|Copyright(c) 2025 First Databank, Inc.||
2685|095|B|||
2686|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2686|002|Z|does NOT have all possible information about this product. This||
2686|003|Z|information does not assure that this product is safe, effective,||
2686|004|Z|or appropriate for you. This information is not individual||
2686|005|Z|medical advice and does not substitute for the advice of your||
2686|006|Z|health care professional. Always ask your health care||
2686|007|Z|professional for complete information about this product and your||
2686|008|Z|specific health needs.||
2686|009|B|||
2686|010|T|COSIBELIMAB - INJECTION||
2686|011|B|||
2686|012|C|COMMON BRAND NAME(S): Unloxcyt||
2686|013|B|||
2686|014|U|USES:  This medication is used to treat certain types of skin||
2686|015|U|cancer. It works by helping your immune system fight the cancer.||
2686|016|U|Cosibelimab belongs to a class of drugs known as monoclonal||
2686|017|U|antibodies.||
2686|018|B|||
2686|019|H|HOW TO USE:  Read the Medication Guide provided by your||
2686|020|H|pharmacist before you start receiving cosibelimab and each time||
2686|021|H|you get a treatment. If you have any questions, ask your doctor||
2686|022|H|or pharmacist.||
2686|023|H|   This medication is given by a health care professional. It is||
2686|024|H|injected slowly into a vein over 60 minutes. It is given as||
2686|025|H|directed by your doctor, usually once every 3 weeks.||
2686|026|H|   Infusion reactions may happen during the infusion of this||
2686|027|H|drug. Your doctor may prescribe other medications before each||
2686|028|H|treatment to help prevent these side effects. Tell your doctor||
2686|029|H|right away if you have any symptoms of infusion reactions such as||
2686|030|H|flushing, trouble breathing, fever, chills, itching, back/neck||
2686|031|H|pain, or dizziness. Your doctor may give you other medications to||
2686|032|H|help with these side effects or may slow down or stop your||
2686|033|H|treatment for some time.||
2686|034|H|   Use this medication regularly to get the most benefit from it.||
2686|035|H|To help you remember, mark your calendar with a reminder.||
2686|036|B|||
2686|037|S|SIDE EFFECTS:  See also How to Use section.||
2686|038|S|   Tiredness, muscle/bone pain, itchy skin, or nausea may occur.||
2686|039|S|If any of these effects last or get worse, tell your doctor or||
2686|040|S|pharmacist promptly.||
2686|041|S|   Remember that this medication has been prescribed because your||
2686|042|S|doctor has judged that the benefit to you is greater than the||
2686|043|S|risk of side effects. Many people using this medication do not||
2686|044|S|have serious side effects.||
2686|045|S|   Tell your doctor right away if you have any serious side||
2686|046|S|effects, including: new/worsening cough, diarrhea, black/tarry||
2686|047|S|stool, signs of liver disease (nausea/vomiting that doesn't stop,||
2686|048|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
2686|049|S|of kidney problems (such as pink/bloody urine, change in the||
2686|050|S|amount of urine), eye/vision problems (such as blurred vision,||
2686|051|S|vision changes, eye pain), headache that is severe or doesn't go||
2686|052|S|away, stiff/painful neck, numbness/tingling of arms/legs,||
2686|053|S|mouth/throat sores, easy bruising/bleeding, signs of anemia (such||
2686|054|S|as pale skin, rapid breathing).||
2686|055|S|   This medication may cause hormone gland problems (such as||
2686|056|S|thyroid, pituitary, adrenal, pancreas). Your body could make too||
2686|057|S|much or too little hormone. Tell your doctor right away if you||
2686|058|S|have any symptoms such as: cold or heat intolerance, unexplained||
2686|059|S|weight loss/gain, increased thirst/urination, mood or behavior||
2686|060|S|changes (such as irritability, forgetfulness, less sex drive),||
2686|061|S|slow/fast/pounding/irregular heartbeat, unusual tiredness,||
2686|062|S|constipation.||
2686|063|S|   Get medical help right away if you have any very serious side||
2686|064|S|effects, including: chest pain, shortness of breath.||
2686|065|S|   A very serious allergic reaction to this drug is rare.||
2686|066|S|However, get medical help right away if you notice any symptoms||
2686|067|S|of a serious allergic reaction, including: fever, swollen lymph||
2686|068|S|nodes, rash, itching/swelling (especially of the||
2686|069|S|face/tongue/throat), severe dizziness, trouble breathing.||
2686|070|S|   This is not a complete list of possible side effects. If you||
2686|071|S|notice other effects not listed above, contact your doctor or||
2686|072|S|pharmacist.||
2686|073|S|   In the US -||
2686|074|S|   Call your doctor for medical advice about side effects. You||
2686|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2686|076|S|www.fda.gov/medwatch.||
2686|077|S|   In Canada - Call your doctor for medical advice about side||
2686|078|S|effects. You may report side effects to Health Canada at||
2686|079|S|1-866-234-2345.||
2686|080|B|||
2686|081|P|PRECAUTIONS:  Before using cosibelimab, tell your doctor or||
2686|082|P|pharmacist if you are allergic to it; or if you have any other||
2686|083|P|allergies. This product may contain inactive ingredients, which||
2686|084|P|can cause allergic reactions or other problems. Talk to your||
2686|085|P|pharmacist for more details.||
2686|086|P|   Before using this medication, tell your doctor or pharmacist||
2686|087|P|your medical history, especially of: immune system problems (such||
2686|088|P|as Crohn's disease, ulcerative colitis, lupus), organ transplant,||
2686|089|P|stem cell transplant with donor cells, radiation treatment,||
2686|090|P|nervous system disorders (such as myasthenia gravis,||
2686|091|P|Guillain-Barre syndrome).||
2686|092|P|   Before having surgery, tell your doctor or dentist about all||
2686|093|P|the products you use (including prescription drugs,||
2686|094|P|nonprescription drugs, and herbal products).||
2686|095|P|   Tell your doctor if you are pregnant or plan to become||
2686|096|P|pregnant. You should not become pregnant while using cosibelimab.||
2686|097|P|Cosibelimab may harm an unborn baby. Ask about reliable forms of||
2686|098|P|birth control while using this medication and for at least 4||
2686|099|P|months after the last dose. If you become pregnant, talk to your||
2686|100|P|doctor right away about the risks and benefits of this||
2686|101|P|medication.||
2686|102|P|   It is unknown if this drug passes into breast milk. Because of||
2686|103|P|the possible risk to the infant, breastfeeding is not recommended||
2686|104|P|while using this drug and for at least 4 months after the last||
2686|105|P|dose. Consult your doctor before breastfeeding.||
2686|106|B|||
2686|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2686|108|I|medications work or increase your risk for serious side effects.||
2686|109|I|This document does not contain all possible drug interactions.||
2686|110|I|Keep a list of all the products you use (including||
2686|111|I|prescription/nonprescription drugs and herbal products) and share||
2686|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2686|113|I|the dosage of any medicines without your doctor's approval.||
2686|114|B|||
2686|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2686|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2686|117|O|poison control center right away. US residents can call||
2686|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2686|119|B|||
2686|120|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
2686|121|N|function) should be done before you start using this medication||
2686|122|N|and while you are using it. Keep all medical and lab||
2686|123|N|appointments.||
2686|124|B|||
2686|125|D|MISSED DOSE:  It is important to get each dose of this medication||
2686|126|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2686|127|D|right away for a new dosing schedule.||
2686|128|B|||
2686|129|R|STORAGE:  Not applicable. This medication is given in a hospital||
2686|130|R|or clinic and will not be stored at home.||
2686|131|B|||
2686|132|A|Information last revised September 2025.||
2686|133|A|Copyright(c) 2025 First Databank, Inc.||
2686|134|B|||
2687|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2687|002|Z|does NOT have all possible information about this product. This||
2687|003|Z|information does not assure that this product is safe, effective,||
2687|004|Z|or appropriate for you. This information is not individual||
2687|005|Z|medical advice and does not substitute for the advice of your||
2687|006|Z|health care professional. Always ask your health care||
2687|007|Z|professional for complete information about this product and your||
2687|008|Z|specific health needs.||
2687|009|B|||
2687|010|T|DONIDALORSEN - INJECTION||
2687|011|B|||
2687|012|C|COMMON BRAND NAME(S): Dawnzera||
2687|013|B|||
2687|014|U|USES:  This medication is used to help prevent severe swelling||
2687|015|U|attacks due to a certain inherited immune disease (hereditary||
2687|016|U|angioedema-HAE). Donidalorsen works by decreasing the amount of a||
2687|017|U|natural substance made by the body (prekallikrein). This effect||
2687|018|U|lowers the amount of another natural substance (bradykinin) that||
2687|019|U|causes symptoms during a sudden HAE attack.||
2687|020|B|||
2687|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
2687|022|H|Instructions for Use if available from your pharmacist before you||
2687|023|H|start using donidalorsen and each time you get a refill. If you||
2687|024|H|have any questions, ask your doctor or pharmacist.||
2687|025|H|   Inject this medication under the skin as directed by your||
2687|026|H|doctor, usually once every 4 or 8 weeks. The injection is given||
2687|027|H|in the upper arms, thighs, or abdomen (except for a 2-inch area||
2687|028|H|around your belly button).||
2687|029|H|   Take the medication out of the refrigerator at least 30||
2687|030|H|minutes before you inject it to allow it to reach room||
2687|031|H|temperature. Do not warm up this medication any other way (for||
2687|032|H|example, do not heat it in the microwave, place it in hot water,||
2687|033|H|or leave it in direct sunlight). Before using, check this product||
2687|034|H|for cloudiness, particles, or discoloration. If you see any of||
2687|035|H|these things, do not use the liquid. Before injecting each dose,||
2687|036|H|clean the skin you are going to inject into (the injection site)||
2687|037|H|with rubbing alcohol. Change the injection site each time to||
2687|038|H|lessen injury under the skin. Do not inject into scars or skin||
2687|039|H|that is tender, bruised, red, hard, or damaged. To lessen||
2687|040|H|bruising, do not rub the injection site after a shot. Learn how||
2687|041|H|to store and discard medical supplies safely.||
2687|042|H|   Use this medication regularly to get the most benefit from it.||
2687|043|H|To help you remember, mark your calendar with a reminder.||
2687|044|H|   Do not increase your dose or use this drug more often or for||
2687|045|H|longer than prescribed. Your condition will not improve any||
2687|046|H|faster, and your risk of side effects will increase.||
2687|047|H|   Tell your doctor if your condition does not get better or if||
2687|048|H|it gets worse.||
2687|049|B|||
2687|050|S|SIDE EFFECTS:  Redness, itching, pain, or bruising at the||
2687|051|S|injection site may occur. Runny/stuffy nose or abdominal pain may||
2687|052|S|also occur. If any of these effects last or get worse, tell your||
2687|053|S|doctor or pharmacist promptly.||
2687|054|S|   Remember that this medication has been prescribed because your||
2687|055|S|doctor has judged that the benefit to you is greater than the||
2687|056|S|risk of side effects. Many people using this medication do not||
2687|057|S|have serious side effects.||
2687|058|S|   Tell your doctor right away if you have any serious side||
2687|059|S|effects, including: signs of infection (such as sore throat that||
2687|060|S|doesn't go away, fever, chills, burning/painful urination).||
2687|061|S|   A very serious allergic reaction to this drug is rare.||
2687|062|S|However, get medical help right away if you notice any symptoms||
2687|063|S|of a serious allergic reaction, including: rash, itching/swelling||
2687|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2687|065|S|breathing.||
2687|066|S|   This is not a complete list of possible side effects. If you||
2687|067|S|notice other effects not listed above, contact your doctor or||
2687|068|S|pharmacist.||
2687|069|S|   In the US -||
2687|070|S|   Call your doctor for medical advice about side effects. You||
2687|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2687|072|S|www.fda.gov/medwatch.||
2687|073|S|   In Canada - Call your doctor for medical advice about side||
2687|074|S|effects. You may report side effects to Health Canada at||
2687|075|S|1-866-234-2345.||
2687|076|B|||
2687|077|P|PRECAUTIONS:  Before using donidalorsen, tell your doctor or||
2687|078|P|pharmacist if you are allergic to it; or if you have any other||
2687|079|P|allergies. This product may contain inactive ingredients, which||
2687|080|P|can cause allergic reactions or other problems. Talk to your||
2687|081|P|pharmacist for more details.||
2687|082|P|   Before using this medication, tell your doctor or pharmacist||
2687|083|P|your medical history, especially of: liver disease.||
2687|084|P|   Before having surgery, tell your doctor or dentist about all||
2687|085|P|the products you use (including prescription drugs,||
2687|086|P|nonprescription drugs, and herbal products).||
2687|087|P|   During pregnancy, this medication should be used only when||
2687|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
2687|089|P|   It is unknown if this medication passes into breast milk.||
2687|090|P|Consult your doctor before breastfeeding.||
2687|091|B|||
2687|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2687|093|I|medications work or increase your risk for serious side effects.||
2687|094|I|This document does not contain all possible drug interactions.||
2687|095|I|Keep a list of all the products you use (including||
2687|096|I|prescription/nonprescription drugs and herbal products) and share||
2687|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
2687|098|I|the dosage of any medicines without your doctor's approval.||
2687|099|B|||
2687|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2687|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2687|102|O|poison control center right away. US residents can call||
2687|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2687|104|B|||
2687|105|N|NOTES:  Do not share this medication with others.||
2687|106|B|||
2687|107|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2687|108|D|Use your next dose on your regular schedule (for example, 4 or 8||
2687|109|D|weeks later). Do not double the dose to catch up.||
2687|110|B|||
2687|111|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2687|112|R|medication in the original carton to protect from light. This||
2687|113|R|medication may also be stored at room temperature if needed. If||
2687|114|R|the medication is stored at room temperature, discard after 6||
2687|115|R|weeks. Keep all medications away from children and pets.||
2687|116|R|   Do not flush medications down the toilet or pour them into a||
2687|117|R|drain unless instructed to do so. Properly discard this product||
2687|118|R|when it is expired or no longer needed. Consult your pharmacist||
2687|119|R|or local waste disposal company.||
2687|120|B|||
2687|121|A|Information last revised September 2025.||
2687|122|A|Copyright(c) 2025 First Databank, Inc.||
2687|123|B|||
2688|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2688|002|Z|does NOT have all possible information about this product. This||
2688|003|Z|information does not assure that this product is safe, effective,||
2688|004|Z|or appropriate for you. This information is not individual||
2688|005|Z|medical advice and does not substitute for the advice of your||
2688|006|Z|health care professional. Always ask your health care||
2688|007|Z|professional for complete information about this product and your||
2688|008|Z|specific health needs.||
2688|009|B|||
2688|010|T|BERBERINE - ORAL||
2688|011|B|||
2688|012|U|USES:  Berberine has been used for diabetes and high cholesterol.||
2688|013|U|Before using any herbal product, talk to your doctor or||
2688|014|U|pharmacist about your medical condition.||
2688|015|U|   Some supplement products have been found to contain possibly||
2688|016|U|harmful impurities/additives. Check with your pharmacist for more||
2688|017|U|details about the brand you use.||
2688|018|U|   The FDA has not reviewed this product for safety or||
2688|019|U|effectiveness. Consult your doctor or pharmacist for more||
2688|020|U|details.||
2688|021|B|||
2688|022|H|HOW TO USE:  Follow all directions on the product package. If||
2688|023|H|your doctor has prescribed this product, take it as directed. If||
2688|024|H|you have any questions, ask your doctor or pharmacist.||
2688|025|H|   Tell your doctor if your condition lasts or gets worse. If you||
2688|026|H|think you may have a serious medical problem, get medical help||
2688|027|H|right away.||
2688|028|B|||
2688|029|S|SIDE EFFECTS:  Stomach upset, gas, diarrhea, constipation,||
2688|030|S|nausea, or vomiting may occur. If any of these effects last or||
2688|031|S|get worse, tell your doctor or pharmacist promptly.||
2688|032|S|   A very serious allergic reaction to this product is rare.||
2688|033|S|However, get medical help right away if you notice any symptoms||
2688|034|S|of a serious allergic reaction, including: rash, itching/swelling||
2688|035|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2688|036|S|breathing.||
2688|037|S|   This is not a complete list of possible side effects. If you||
2688|038|S|notice other effects not listed above, contact your doctor or||
2688|039|S|pharmacist.||
2688|040|S|   In the US -||
2688|041|S|   Call your doctor for medical advice about side effects. You||
2688|042|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2688|043|S|www.fda.gov/medwatch.||
2688|044|S|   In Canada - Call your doctor for medical advice about side||
2688|045|S|effects. You may report side effects to Health Canada at||
2688|046|S|1-866-234-2345.||
2688|047|B|||
2688|048|P|PRECAUTIONS:  Before taking berberine, tell your doctor or||
2688|049|P|pharmacist if you are allergic to it; or if you have any other||
2688|050|P|allergies. This product may contain inactive ingredients, which||
2688|051|P|can cause allergic reactions or other problems. Talk to your||
2688|052|P|pharmacist for more details.||
2688|053|P|   If you have any health problems, consult your doctor or||
2688|054|P|pharmacist before using this product.||
2688|055|P|   Before having surgery, tell your doctor or dentist about all||
2688|056|P|the products you use (including prescription drugs,||
2688|057|P|nonprescription drugs, and herbal products).||
2688|058|P|   This product must not be used during pregnancy. It may harm an||
2688|059|P|unborn baby. If you become pregnant or think you may be pregnant,||
2688|060|P|tell your doctor right away.||
2688|061|P|   It is unknown if this product passes into breast milk.||
2688|062|P|Breastfeeding is not recommended while using this product.||
2688|063|P|Consult your doctor before breastfeeding.||
2688|064|B|||
2688|065|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2688|066|I|medications work or increase your risk for serious side effects.||
2688|067|I|This document does not contain all possible drug interactions.||
2688|068|I|Keep a list of all the products you use (including||
2688|069|I|prescription/nonprescription drugs and herbal products) and share||
2688|070|I|it with your doctor and pharmacist. Do not start, stop, or change||
2688|071|I|the dosage of any medicines without your doctor's approval.||
2688|072|I|   This product can slow down the removal of other medications||
2688|073|I|from your body, which may affect how they work. Examples of||
2688|074|I|affected drugs include cyclosporine, lemborexant, among others.||
2688|075|B|||
2688|076|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2688|077|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2688|078|O|poison control center right away. US residents can call||
2688|079|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2688|080|B|||
2688|081|N|NOTES:  Keep all medical and lab appointments.||
2688|082|B|||
2688|083|D|MISSED DOSE:  If you are taking this product on a regular||
2688|084|D|schedule and miss a dose, take it as soon as you remember. If it||
2688|085|D|is near the time of the next dose, skip the missed dose. Take||
2688|086|D|your next dose at the regular time. Do not double the dose to||
2688|087|D|catch up.||
2688|088|B|||
2688|089|R|STORAGE:  Refer to storage information printed on the package. If||
2688|090|R|you have any questions about storage, ask your pharmacist. Keep||
2688|091|R|all medications and herbal products away from children and pets.||
2688|092|R|   Do not flush medications down the toilet or pour them into a||
2688|093|R|drain unless instructed to do so. Properly discard this product||
2688|094|R|when it is expired or no longer needed. Consult your pharmacist||
2688|095|R|or local waste disposal company.||
2688|096|B|||
2688|097|A|Information last revised September 2025.||
2688|098|A|Copyright(c) 2025 First Databank, Inc.||
2688|099|B|||
2689|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2689|002|Z|does NOT have all possible information about this product. This||
2689|003|Z|information does not assure that this product is safe, effective,||
2689|004|Z|or appropriate for you. This information is not individual||
2689|005|Z|medical advice and does not substitute for the advice of your||
2689|006|Z|health care professional. Always ask your health care||
2689|007|Z|professional for complete information about this product and your||
2689|008|Z|specific health needs.||
2689|009|B|||
2689|010|T|GEPOTIDACIN - ORAL||
2689|011|F|(JEP-oh-ti-DAY-sin)||
2689|012|B|||
2689|013|C|COMMON BRAND NAME(S): Blujepa||
2689|014|B|||
2689|015|U|USES:  Gepotidacin is used to treat bladder infections (urinary||
2689|016|U|tract infections) in women and girls. This medication is an||
2689|017|U|antibiotic. It works by stopping the growth of bacteria.||
2689|018|U|   This antibiotic treats only bacterial infections. It will not||
2689|019|U|work for viral infections (such as common cold, flu). Using any||
2689|020|U|antibiotic when it is not needed can cause it to not work for||
2689|021|U|future infections.||
2689|022|B|||
2689|023|H|HOW TO USE:  Read the Medication Guide provided by your||
2689|024|H|pharmacist before you start taking gepotidacin and each time you||
2689|025|H|get a refill. If you have any questions, ask your doctor or||
2689|026|H|pharmacist.||
2689|027|H|   Take this medication by mouth after a meal as directed by your||
2689|028|H|doctor, usually twice a day (about 12 hours apart).||
2689|029|H|   For the best effect, take this antibiotic at evenly spaced||
2689|030|H|times. To help you remember, take this medication at the same||
2689|031|H|times every day.||
2689|032|H|   Continue to take this medication until the full prescribed||
2689|033|H|amount is finished, even if symptoms disappear after a few days.||
2689|034|H|Stopping the medication too early may result in a return of the||
2689|035|H|infection.||
2689|036|H|   Tell your doctor if your condition lasts or gets worse.||
2689|037|B|||
2689|038|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach/abdominal||
2689|039|S|pain, dizziness, or headache may occur. If any of these effects||
2689|040|S|last or get worse, tell your doctor or pharmacist promptly.||
2689|041|S|   Remember that this medication has been prescribed because your||
2689|042|S|doctor has judged that the benefit to you is greater than the||
2689|043|S|risk of side effects. Many people using this medication do not||
2689|044|S|have serious side effects.||
2689|045|S|   Tell your doctor right away if you have any serious side||
2689|046|S|effects, including: trouble speaking, muscle spasms, increased||
2689|047|S|sweating, increased saliva.||
2689|048|S|   Get medical help right away if you have any very serious side||
2689|049|S|effects, including: fast/slow/irregular heartbeat, severe||
2689|050|S|dizziness, fainting, seizures.||
2689|051|S|   This medication may rarely cause a severe intestinal condition||
2689|052|S|due to a bacteria called C. difficile. This condition may occur||
2689|053|S|during treatment or weeks to months after treatment has stopped.||
2689|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
2689|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
2689|056|S|stool.||
2689|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
2689|058|S|products because they may make symptoms worse.||
2689|059|S|   This medication may sometimes cause oral thrush or a new yeast||
2689|060|S|infection. Contact your doctor if you notice white patches in||
2689|061|S|your mouth, a change in vaginal discharge, or other new symptoms.||
2689|062|S|   A very serious allergic reaction to this drug is rare.||
2689|063|S|However, get medical help right away if you notice any symptoms||
2689|064|S|of a serious allergic reaction, including: rash, itching/swelling||
2689|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2689|066|S|breathing.||
2689|067|S|   This is not a complete list of possible side effects. If you||
2689|068|S|notice other effects not listed above, contact your doctor or||
2689|069|S|pharmacist.||
2689|070|S|   In the US -||
2689|071|S|   Call your doctor for medical advice about side effects. You||
2689|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2689|073|S|www.fda.gov/medwatch.||
2689|074|S|   In Canada - Call your doctor for medical advice about side||
2689|075|S|effects. You may report side effects to Health Canada at||
2689|076|S|1-866-234-2345.||
2689|077|B|||
2689|078|P|PRECAUTIONS:  Before taking gepotidacin, tell your doctor or||
2689|079|P|pharmacist if you are allergic to it; or if you have any other||
2689|080|P|allergies. This product may contain inactive ingredients, which||
2689|081|P|can cause allergic reactions or other problems. Talk to your||
2689|082|P|pharmacist for more details.||
2689|083|P|   Before using this medication, tell your doctor or pharmacist||
2689|084|P|your medical history, especially of: liver disease, kidney||
2689|085|P|disease.||
2689|086|P|   Gepotidacin may cause a condition that affects the heart||
2689|087|P|rhythm (QT prolongation). QT prolongation can rarely cause||
2689|088|P|serious (rarely fatal) fast/irregular heartbeat and other||
2689|089|P|symptoms (such as severe dizziness, fainting) that need medical||
2689|090|P|attention right away.||
2689|091|P|   The risk of QT prolongation may be increased if you have||
2689|092|P|certain medical conditions or are taking other drugs that may||
2689|093|P|cause QT prolongation. Before using gepotidacin, tell your doctor||
2689|094|P|or pharmacist of all the drugs you take and if you have any of||
2689|095|P|the following conditions: certain heart problems (heart failure,||
2689|096|P|slow heartbeat, QT prolongation in the EKG), family history of||
2689|097|P|certain heart problems (QT prolongation in the EKG, sudden||
2689|098|P|cardiac death).||
2689|099|P|   Low levels of potassium or magnesium in the blood may also||
2689|100|P|increase your risk of QT prolongation. This risk may increase if||
2689|101|P|you use certain drugs (such as diuretics/"water pills") or if you||
2689|102|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2689|103|P|Talk to your doctor about using gepotidacin safely.||
2689|104|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2689|105|P|can make you more dizzy. Do not drive, use machinery, or do||
2689|106|P|anything that needs alertness until you can do it safely. Limit||
2689|107|P|alcoholic beverages. Talk to your doctor if you are using||
2689|108|P|marijuana (cannabis).||
2689|109|P|   Gepotidacin may cause live bacterial vaccines (such as typhoid||
2689|110|P|vaccine) to not work well. Tell your health care professional||
2689|111|P|that you are using gepotidacin before having any||
2689|112|P|immunizations/vaccinations.||
2689|113|P|   Before having surgery, tell your doctor or dentist about all||
2689|114|P|the products you use (including prescription drugs,||
2689|115|P|nonprescription drugs, and herbal products).||
2689|116|P|   Older adults may be more sensitive to the side effects of this||
2689|117|P|drug, especially QT prolongation (see above).||
2689|118|P|   During pregnancy, this medication should be used only when||
2689|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
2689|120|P|   It is unknown if this medication passes into breast milk.||
2689|121|P|Consult your doctor before breastfeeding.||
2689|122|B|||
2689|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2689|124|I|medications work or increase your risk for serious side effects.||
2689|125|I|This document does not contain all possible drug interactions.||
2689|126|I|Keep a list of all the products you use (including||
2689|127|I|prescription/nonprescription drugs and herbal products) and share||
2689|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
2689|129|I|the dosage of any medicines without your doctor's approval.||
2689|130|I|   Other medications can affect the removal of gepotidacin from||
2689|131|I|your body, which may affect how gepotidacin works. Examples||
2689|132|I|include azole antifungals (such as itraconazole, ketoconazole),||
2689|133|I|rifamycins (such as rifampin), among others.||
2689|134|I|   This medication can slow down the removal of other medications||
2689|135|I|from your body, which may affect how they work. Examples of||
2689|136|I|affected drugs include cyclosporine, quinidine, among others.||
2689|137|B|||
2689|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2689|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2689|140|O|poison control center right away. US residents can call||
2689|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2689|142|O|Symptoms of overdose may include: severe dizziness,||
2689|143|O|fast/irregular heartbeat, fainting.||
2689|144|B|||
2689|145|N|NOTES:  Do not share this medication with others.||
2689|146|N|   This medication has been prescribed for your current condition||
2689|147|N|only. Do not use it later for another infection unless your||
2689|148|N|doctor tells you to.||
2689|149|B|||
2689|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2689|151|D|remember. If it is near the time of the next dose, skip the||
2689|152|D|missed dose. Take your next dose at the regular time. Do not||
2689|153|D|double the dose to catch up.||
2689|154|B|||
2689|155|R|STORAGE:  Store at room temperature away from light and moisture.||
2689|156|R|Do not store in the bathroom. Keep all medications away from||
2689|157|R|children and pets.||
2689|158|R|   Do not flush medications down the toilet or pour them into a||
2689|159|R|drain unless instructed to do so. Properly discard this product||
2689|160|R|when it is expired or no longer needed. Consult your pharmacist||
2689|161|R|or local waste disposal company.||
2689|162|B|||
2689|163|A|Information last revised September 2025.||
2689|164|A|Copyright(c) 2025 First Databank, Inc.||
2689|165|B|||
2690|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2690|002|Z|does NOT have all possible information about this product. This||
2690|003|Z|information does not assure that this product is safe, effective,||
2690|004|Z|or appropriate for you. This information is not individual||
2690|005|Z|medical advice and does not substitute for the advice of your||
2690|006|Z|health care professional. Always ask your health care||
2690|007|Z|professional for complete information about this product and your||
2690|008|Z|specific health needs.||
2690|009|B|||
2690|010|T|NALMEFENE AUTO-INJECTOR - INJECTION||
2690|011|F|(NAL-me-feen)||
2690|012|B|||
2690|013|C|COMMON BRAND NAME(S): Zurnai||
2690|014|B|||
2690|015|U|USES:  Nalmefene is used for the emergency treatment of known or||
2690|016|U|suspected opioid overdose. Serious opioid overdose symptoms may||
2690|017|U|include unusual sleepiness, unusual difficulty waking up, or||
2690|018|U|breathing problems (ranging from slow/shallow breathing to no||
2690|019|U|breathing). Other symptoms of overdose may include very small||
2690|020|U|"pinpoint" pupils, slow heartbeat, or low blood pressure. If||
2690|021|U|someone has serious overdose symptoms but you are not sure if the||
2690|022|U|symptoms are due to opioid overdose, give nalmefene right away||
2690|023|U|anyway, since lasting slow/shallow breathing may cause permanent||
2690|024|U|damage to the brain or death. Since symptoms of opioid overdose||
2690|025|U|may return after treatment, be sure to get medical help right||
2690|026|U|away after giving the first dose of nalmefene.||
2690|027|U|   This medication belongs to a class of drugs known as opioid||
2690|028|U|antagonists. It works by blocking the effects of the opioid in||
2690|029|U|the brain.||
2690|030|B|||
2690|031|H|HOW TO USE:  Read the Patient Information Leaflet and||
2690|032|H|Instructions for Use if available from your pharmacist when you||
2690|033|H|get this medication and each time you get a refill. Be sure to||
2690|034|H|keep this medication handy in case it is needed. Learn ahead of||
2690|035|H|time how to properly give this medication. If you have any||
2690|036|H|questions, ask your doctor or pharmacist.||
2690|037|H|   Close family and household members should know the symptoms of||
2690|038|H|an opioid overdose and be instructed on how to give nalmefene if||
2690|039|H|needed. Opioid overdose should be treated right away to prevent||
2690|040|H|serious effects (such as brain damage). See also Uses section.||
2690|041|H|   The solution in the auto-injector should be clear, colorless||
2690|042|H|to light yellow. From time to time, check this product for||
2690|043|H|particles or discoloration. If either is present, do not use the||
2690|044|H|product. Discard and replace the auto-injector. Learn how to||
2690|045|H|store and discard medical supplies safely.||
2690|046|H|   Remove the nalmefene auto-injector from the package only when||
2690|047|H|you are ready to use it. Inject this medication into the outer||
2690|048|H|thigh as directed by your doctor. This medication can be injected||
2690|049|H|through clothing if needed.||
2690|050|H|   After giving nalmefene, get medical help right away, even if||
2690|051|H|the person wakes up. If symptoms return after giving the||
2690|052|H|injection, give another dose every 2 to 5 minutes. Each||
2690|053|H|auto-injector contains only one dose and cannot be reused.||
2690|054|H|Continue to closely watch the person until emergency help comes.||
2690|055|H|Tell the health care professional that you have given nalmefene.||
2690|056|B|||
2690|057|S|SIDE EFFECTS:  Headache, nausea, vomiting, flushing, chills, or||
2690|058|S|dizziness may occur. If any of these effects last or get worse,||
2690|059|S|tell your doctor or pharmacist promptly.||
2690|060|S|   Remember that this medication has been prescribed because your||
2690|061|S|doctor has judged that the benefit to you is greater than the||
2690|062|S|risk of side effects. Many people using this medication do not||
2690|063|S|have serious side effects.||
2690|064|S|   In someone who has been using an opioid regularly, withdrawal||
2690|065|S|symptoms can happen suddenly after receiving this medication.||
2690|066|S|Withdrawal symptoms may include body aches, fever, sweating,||
2690|067|S|watering eyes, runny nose, sneezing, goose bumps, yawning,||
2690|068|S|weakness, shivering/trembling, nervousness, restlessness,||
2690|069|S|diarrhea, nausea, vomiting, stomach cramps, increased blood||
2690|070|S|pressure, or fast heartbeat.||
2690|071|S|   A very serious allergic reaction to this drug is rare.||
2690|072|S|However, get medical help right away if you notice any symptoms||
2690|073|S|of a serious allergic reaction, including: rash, itching/swelling||
2690|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2690|075|S|breathing.||
2690|076|S|   This is not a complete list of possible side effects. If you||
2690|077|S|notice other effects not listed above, contact your doctor or||
2690|078|S|pharmacist.||
2690|079|S|   In the US -||
2690|080|S|   Call your doctor for medical advice about side effects. You||
2690|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2690|082|S|www.fda.gov/medwatch.||
2690|083|S|   In Canada - Call your doctor for medical advice about side||
2690|084|S|effects. You may report side effects to Health Canada at||
2690|085|S|1-866-234-2345.||
2690|086|B|||
2690|087|P|PRECAUTIONS:  Before using nalmefene, tell your doctor or||
2690|088|P|pharmacist if you are allergic to it; or if you have any other||
2690|089|P|allergies. This product may contain inactive ingredients, which||
2690|090|P|can cause allergic reactions or other problems. Talk to your||
2690|091|P|pharmacist for more details.||
2690|092|P|   Before using this medication, tell your doctor or pharmacist||
2690|093|P|your medical history.||
2690|094|P|   Before having surgery, tell your doctor or dentist about all||
2690|095|P|the products you use (including prescription drugs,||
2690|096|P|nonprescription drugs, and herbal products).||
2690|097|P|   Since untreated opioid overdose can harm both a pregnant woman||
2690|098|P|and her unborn baby, this medication may be used during||
2690|099|P|pregnancy. However, nalmefene may cause opioid withdrawal in your||
2690|100|P|unborn baby. Tell your doctor right away that you used this||
2690|101|P|medication, so you and your unborn baby can be monitored. Ask||
2690|102|P|your doctor for details.||
2690|103|P|   It is unknown if this medication passes into breast milk.||
2690|104|P|However, it is unlikely to harm a nursing infant. Consult your||
2690|105|P|doctor before breastfeeding.||
2690|106|B|||
2690|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2690|108|I|medications work or increase your risk for serious side effects.||
2690|109|I|This document does not contain all possible drug interactions.||
2690|110|I|Keep a list of all the products you use (including||
2690|111|I|prescription/nonprescription drugs and herbal products) and share||
2690|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
2690|113|I|the dosage of any medicines without your doctor's approval.||
2690|114|B|||
2690|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2690|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2690|117|O|poison control center right away. US residents can call||
2690|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2690|119|B|||
2690|120|N|NOTES:  Ask your doctor or pharmacist about ways to prevent||
2690|121|N|opioid overdose. Teach your close family or household members the||
2690|122|N|signs and symptoms of an opioid overdose and tell them where you||
2690|123|N|keep this medication.||
2690|124|B|||
2690|125|D|MISSED DOSE:  Not applicable.||
2690|126|B|||
2690|127|R|STORAGE:  Store at room temperature. Do not refrigerate or||
2690|128|R|freeze. Keep the medication in the original carton to protect||
2690|129|R|from light. From time to time, check the expiration date and||
2690|130|R|replace the medication before it expires. Keep all medications||
2690|131|R|away from children and pets.||
2690|132|R|   Do not flush medications down the toilet or pour them into a||
2690|133|R|drain unless instructed to do so. Properly discard this||
2690|134|R|medication when it is expired or no longer needed. Consult your||
2690|135|R|pharmacist or local waste disposal company.||
2690|136|B|||
2690|137|A|Information last revised September 2025.||
2690|138|A|Copyright(c) 2025 First Databank, Inc.||
2690|139|B|||
2691|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2691|002|Z|does NOT have all possible information about this product. This||
2691|003|Z|information does not assure that this product is safe, effective,||
2691|004|Z|or appropriate for you. This information is not individual||
2691|005|Z|medical advice and does not substitute for the advice of your||
2691|006|Z|health care professional. Always ask your health care||
2691|007|Z|professional for complete information about this product and your||
2691|008|Z|specific health needs.||
2691|009|B|||
2691|010|T|RILZABRUTINIB - ORAL||
2691|011|F|(RIL-za-BROO-ti-nib)||
2691|012|B|||
2691|013|C|COMMON BRAND NAME(S): Wayrilz||
2691|014|B|||
2691|015|U|USES:  This medication is used to treat people with a certain||
2691|016|U|blood disorder known as chronic immune thrombocytopenia-ITP. This||
2691|017|U|is a condition where the amount of one type of cell in your blood||
2691|018|U|(platelets) is lower than normal. ITP can lead to serious||
2691|019|U|bleeding problems. Rilzabrutinib belongs to a class of drugs||
2691|020|U|known as kinase inhibitors. It works by increasing platelets in||
2691|021|U|your blood.||
2691|022|B|||
2691|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2691|024|H|from your pharmacist before you start taking rilzabrutinib and||
2691|025|H|each time you get a refill. If you have any questions, ask your||
2691|026|H|doctor or pharmacist.||
2691|027|H|   Take this medication by mouth with or without food as directed||
2691|028|H|by your doctor, usually twice daily. If you have stomach upset,||
2691|029|H|you may take this medication with food. Swallow the tablets whole||
2691|030|H|with water. Do not split, crush, or chew the tablets.||
2691|031|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2691|032|H|using this medication unless your doctor or pharmacist says you||
2691|033|H|may do so safely. Also avoid eating Seville oranges (often found||
2691|034|H|in marmalade) and star fruit. Grapefruit, Seville oranges, and||
2691|035|H|star fruit can increase the chance of side effects with this||
2691|036|H|medicine. Ask your doctor or pharmacist for more details.||
2691|037|H|   Medications that reduce stomach acid (such as antacids, proton||
2691|038|H|pump inhibitors/PPIs, H2 blockers) may make rilzabrutinib work||
2691|039|H|less well. Do not take PPIs (such as lansoprazole, omeprazole)||
2691|040|H|while using this medication. If you take antacids or H2 blockers||
2691|041|H|(such as famotidine, nizatidine), take rilzabrutinib 2 hours||
2691|042|H|before taking the antacid or H2 blocker.||
2691|043|H|   Use this medication regularly to get the most benefit from it.||
2691|044|H|To help you remember, take it at the same times each day.||
2691|045|H|   Do not increase your dose or use this drug more often or for||
2691|046|H|longer than prescribed. Your condition will not improve any||
2691|047|H|faster, and your risk of serious side effects will increase.||
2691|048|H|   Since this drug can be absorbed through the skin and lungs and||
2691|049|H|may harm an unborn baby, women who are pregnant or who may become||
2691|050|H|pregnant should not handle this medication or breathe the dust||
2691|051|H|from the tablets.||
2691|052|B|||
2691|053|S|SIDE EFFECTS:  Diarrhea, nausea/vomiting, headache, upset||
2691|054|S|stomach, dizziness, or muscle/joint pain may occur. If any of||
2691|055|S|these effects last or get worse, tell your doctor or pharmacist||
2691|056|S|promptly.||
2691|057|S|   Remember that this medication has been prescribed because your||
2691|058|S|doctor has judged that the benefit to you is greater than the||
2691|059|S|risk of side effects. Many people using this medication do not||
2691|060|S|have serious side effects.||
2691|061|S|   Tell your doctor right away if you have any serious side||
2691|062|S|effects, including: signs of liver disease (such as||
2691|063|S|nausea/vomiting that doesn't stop, loss of appetite,||
2691|064|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2691|065|S|   This medication may lower your ability to fight infections.||
2691|066|S|This may make you more likely to get a serious (rarely fatal)||
2691|067|S|infection or make any infection you have worse. Tell your doctor||
2691|068|S|right away if you have any signs of infection (such as sore||
2691|069|S|throat that doesn't go away, fever, chills).||
2691|070|S|   A very serious allergic reaction to this drug is rare.||
2691|071|S|However, get medical help right away if you notice any symptoms||
2691|072|S|of a serious allergic reaction, including: rash, itching/swelling||
2691|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2691|074|S|breathing.||
2691|075|S|   This is not a complete list of possible side effects. If you||
2691|076|S|notice other effects not listed above, contact your doctor or||
2691|077|S|pharmacist.||
2691|078|S|   In the US -||
2691|079|S|   Call your doctor for medical advice about side effects. You||
2691|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2691|081|S|www.fda.gov/medwatch.||
2691|082|S|   In Canada - Call your doctor for medical advice about side||
2691|083|S|effects. You may report side effects to Health Canada at||
2691|084|S|1-866-234-2345.||
2691|085|B|||
2691|086|P|PRECAUTIONS:  Before taking rilzabrutinib, tell your doctor or||
2691|087|P|pharmacist if you are allergic to it; or if you have any other||
2691|088|P|allergies. This product may contain inactive ingredients, which||
2691|089|P|can cause allergic reactions or other problems. Talk to your||
2691|090|P|pharmacist for more details.||
2691|091|P|   Before using this medication, tell your doctor or pharmacist||
2691|092|P|your medical history, especially of: kidney disease, liver||
2691|093|P|disease.||
2691|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2691|095|P|can make you more dizzy. Do not drive, use machinery, or do||
2691|096|P|anything that needs alertness until you can do it safely. Limit||
2691|097|P|alcoholic beverages. Talk to your doctor if you are using||
2691|098|P|marijuana (cannabis).||
2691|099|P|   Rilzabrutinib can make you more likely to get infections or||
2691|100|P|may make current infections worse. Stay away from anyone who has||
2691|101|P|an infection that may easily spread (such as chickenpox,||
2691|102|P|COVID-19, measles, flu). Talk to your doctor if you have been||
2691|103|P|exposed to an infection or for more details.||
2691|104|P|   Tell your health care professional that you are using||
2691|105|P|rilzabrutinib before having any immunizations/vaccinations. Avoid||
2691|106|P|contact with people who have recently received live vaccines||
2691|107|P|(such as flu vaccine inhaled through the nose).||
2691|108|P|   Before having surgery, tell your doctor or dentist about all||
2691|109|P|the products you use (including prescription drugs,||
2691|110|P|nonprescription drugs, and herbal products).||
2691|111|P|   Since this drug can be absorbed through the skin and lungs and||
2691|112|P|may harm an unborn baby, women who are pregnant or who may become||
2691|113|P|pregnant should not handle this medication or breathe the dust||
2691|114|P|from the tablets.||
2691|115|P|   Tell your doctor if you are pregnant or plan to become||
2691|116|P|pregnant. You should not become pregnant while using||
2691|117|P|rilzabrutinib. Rilzabrutinib may harm an unborn baby. Your doctor||
2691|118|P|should order a pregnancy test before you start this medication.||
2691|119|P|Ask about reliable forms of birth control while using this||
2691|120|P|medication and for at least 1 week after the last dose. If you||
2691|121|P|become pregnant, talk to your doctor right away about the risks||
2691|122|P|and benefits of this medication.||
2691|123|P|   It is unknown if this drug passes into breast milk. Because of||
2691|124|P|the possible risk to the infant, breastfeeding is not recommended||
2691|125|P|while using this drug and for at least 1 week after the last||
2691|126|P|dose. Consult your doctor before breastfeeding.||
2691|127|B|||
2691|128|I|DRUG INTERACTIONS:  See also How to Use section.||
2691|129|I|   Drug interactions may change how your medications work or||
2691|130|I|increase your risk for serious side effects. This document does||
2691|131|I|not contain all possible drug interactions. Keep a list of all||
2691|132|I|the products you use (including prescription/nonprescription||
2691|133|I|drugs and herbal products) and share it with your doctor and||
2691|134|I|pharmacist. Do not start, stop, or change the dosage of any||
2691|135|I|medicines without your doctor's approval.||
2691|136|I|   Other medications can affect the removal of rilzabrutinib from||
2691|137|I|your body, which may affect how rilzabrutinib works. Examples||
2691|138|I|include azole antifungals (such as fluconazole), efavirenz,||
2691|139|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
2691|140|I|rifampin, rifabutin), ritonavir, verapamil, among others.||
2691|141|I|   This medication can slow down the removal of other medications||
2691|142|I|from your body, which may affect how they work. Examples of||
2691|143|I|affected drugs include flibanserin, lomitapide, midazolam, among||
2691|144|I|others.||
2691|145|B|||
2691|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2691|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2691|148|O|poison control center right away. US residents can call||
2691|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2691|150|B|||
2691|151|N|NOTES:  Do not share this medication with others.||
2691|152|N|   Lab and/or medical tests (such as liver function, complete||
2691|153|N|blood counts) should be done before you start taking this||
2691|154|N|medication and while you are taking it. Keep all medical and lab||
2691|155|N|appointments.||
2691|156|B|||
2691|157|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2691|158|D|remember. If it is within 2 hours of the next dose, skip the||
2691|159|D|missed dose. Take your next dose at the regular time. Do not||
2691|160|D|double the dose to catch up.||
2691|161|B|||
2691|162|R|STORAGE:  Store in the original container at room temperature||
2691|163|R|away from light and moisture. Do not store in the bathroom. Keep||
2691|164|R|all medications away from children and pets.||
2691|165|R|   Do not flush medications down the toilet or pour them into a||
2691|166|R|drain unless instructed to do so. Properly discard this product||
2691|167|R|when it is expired or no longer needed. Consult your pharmacist||
2691|168|R|or local waste disposal company.||
2691|169|B|||
2691|170|M|MEDICAL ALERT:  Your condition can cause complications in a||
2691|171|M|medical emergency. For information about enrolling in MedicAlert,||
2691|172|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2691|173|B|||
2691|174|A|Information last revised September 2025.||
2691|175|A|Copyright(c) 2025 First Databank, Inc.||
2691|176|B|||
2692|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2692|002|Z|does NOT have all possible information about this product. This||
2692|003|Z|information does not assure that this product is safe, effective,||
2692|004|Z|or appropriate for you. This information is not individual||
2692|005|Z|medical advice and does not substitute for the advice of your||
2692|006|Z|health care professional. Always ask your health care||
2692|007|Z|professional for complete information about this product and your||
2692|008|Z|specific health needs.||
2692|009|B|||
2692|010|T|LECANEMAB - SUBCUTANEOUS INJECTION||
2692|011|F|(lek-AN-e-mab)||
2692|012|B|||
2692|013|C|COMMON BRAND NAME(S): Leqembi Iqlik||
2692|014|B|||
2692|015|W|WARNING:  This medication may increase your risk of serious||
2692|016|W|(possibly fatal) side effects such as temporary swelling of the||
2692|017|W|brain, or small spots of bleeding in or on the surface of the||
2692|018|W|brain. These side effects are also known as amyloid-related||
2692|019|W|imaging abnormalities (ARIA). Your doctor may order a genetic||
2692|020|W|test to measure your risk for ARIA before you start this||
2692|021|W|medication. If the genetic test shows you are at greater risk,||
2692|022|W|your doctor should discuss with you the risks and benefits of||
2692|023|W|starting lecanemab. Your doctor will do magnetic resonance||
2692|024|W|imaging (MRI) scans before and during treatment to check for||
2692|025|W|these side effects. If you are also taking medications that can||
2692|026|W|cause bleeding/bruising (including antiplatelet drugs such as||
2692|027|W|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
2692|028|W|such as warfarin/dabigatran), your doctor will monitor you more||
2692|029|W|closely for bleeding. ARIA usually go away over time. They do not||
2692|030|W|always cause symptoms, but tell your doctor right away if you||
2692|031|W|develop symptoms such as headache, dizziness, nausea, confusion,||
2692|032|W|seizures, trouble walking, or vision changes.||
2692|033|B|||
2692|034|U|USES:  This medication is used to treat Alzheimer's disease. It||
2692|035|U|is thought to work by decreasing a certain substance (amyloid||
2692|036|U|beta) that builds up in the brain of a person with Alzheimer's||
2692|037|U|disease. Lecanemab belongs to a class of drugs known as||
2692|038|U|monoclonal antibodies. This medication is not a cure for||
2692|039|U|Alzheimer's disease. It may help slow down worsening of this||
2692|040|U|disease and may delay disability.||
2692|041|B|||
2692|042|H|HOW TO USE:  Read the Medication Guide and, if available, the||
2692|043|H|Instructions for Use provided by your pharmacist before you start||
2692|044|H|using lecanemab and each time you get a refill. If you have any||
2692|045|H|questions, ask your doctor or pharmacist.||
2692|046|H|   Inject this medication under the skin as directed by your||
2692|047|H|doctor, usually once every week. The injection is given in the||
2692|048|H|upper arms, thighs, or abdomen (except for a 2-inch area around||
2692|049|H|your belly button). This form of lecanemab is used only after||
2692|050|H|receiving lecanemab in a vein as directed by your doctor, usually||
2692|051|H|for 18 months. Carefully follow your doctor's directions for when||
2692|052|H|to start using this medication.||
2692|053|H|   Take the medication out of the refrigerator at least 20||
2692|054|H|minutes before you inject it to allow it to reach room||
2692|055|H|temperature. Do not warm up this medication any other way (for||
2692|056|H|example, do not heat it in the microwave, place it in hot water,||
2692|057|H|or leave it in direct sunlight). Do not shake the medication.||
2692|058|H|Before using, check this product for cloudiness, particles, or||
2692|059|H|discoloration. If you see any of these things, do not use the||
2692|060|H|liquid. Before injecting each dose, clean the skin you are going||
2692|061|H|to inject into (the injection site) with rubbing alcohol. Change||
2692|062|H|the injection site each time to lessen injury under the skin. Do||
2692|063|H|not inject into skin that is tender, bruised, red, hard, or||
2692|064|H|damaged or into moles or scars. To lessen bruising, do not rub||
2692|065|H|the injection site after a shot. Learn how to store and discard||
2692|066|H|medical supplies safely.||
2692|067|H|   Use this medication regularly to get the most benefit from it.||
2692|068|H|To help you remember, mark your calendar with a reminder.||
2692|069|B|||
2692|070|S|SIDE EFFECTS:  See also Warning section.||
2692|071|S|   Redness, swelling, itching, rash, pain, or bruising at the||
2692|072|S|injection site may occur. If any of these effects last or get||
2692|073|S|worse, tell your doctor or pharmacist promptly.||
2692|074|S|   Remember that this medication has been prescribed because your||
2692|075|S|doctor has judged that the benefit to you is greater than the||
2692|076|S|risk of side effects. Many people using this medication do not||
2692|077|S|have serious side effects.||
2692|078|S|   A very serious allergic reaction to this drug is rare.||
2692|079|S|However, get medical help right away if you notice any symptoms||
2692|080|S|of a serious allergic reaction, including: rash, itching/swelling||
2692|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2692|082|S|breathing.||
2692|083|S|   This is not a complete list of possible side effects. If you||
2692|084|S|notice other effects not listed above, contact your doctor or||
2692|085|S|pharmacist.||
2692|086|S|   In the US -||
2692|087|S|   Call your doctor for medical advice about side effects. You||
2692|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2692|089|S|www.fda.gov/medwatch.||
2692|090|S|   In Canada - Call your doctor for medical advice about side||
2692|091|S|effects. You may report side effects to Health Canada at||
2692|092|S|1-866-234-2345.||
2692|093|B|||
2692|094|P|PRECAUTIONS:  Before using lecanemab, tell your doctor or||
2692|095|P|pharmacist if you are allergic to it; or if you have any other||
2692|096|P|allergies. This product may contain inactive ingredients, which||
2692|097|P|can cause allergic reactions or other problems. Talk to your||
2692|098|P|pharmacist for more details.||
2692|099|P|   Before using this medication, tell your doctor or pharmacist||
2692|100|P|your medical history.||
2692|101|P|   Before having surgery, tell your doctor or dentist about all||
2692|102|P|the products you use (including prescription drugs,||
2692|103|P|nonprescription drugs, and herbal products).||
2692|104|P|   During pregnancy, this medication should be used only when||
2692|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
2692|106|P|   It is unknown if this medication passes into breast milk.||
2692|107|P|Consult your doctor before breastfeeding.||
2692|108|B|||
2692|109|I|DRUG INTERACTIONS:  See also Warning section.||
2692|110|I|   Drug interactions may change how your medications work or||
2692|111|I|increase your risk for serious side effects. This document does||
2692|112|I|not contain all possible drug interactions. Keep a list of all||
2692|113|I|the products you use (including prescription/nonprescription||
2692|114|I|drugs and herbal products) and share it with your doctor and||
2692|115|I|pharmacist. Do not start, stop, or change the dosage of any||
2692|116|I|medicines without your doctor's approval.||
2692|117|B|||
2692|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2692|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2692|120|O|poison control center right away. US residents can call||
2692|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2692|122|B|||
2692|123|N|NOTES:  Do not share this medication with others.||
2692|124|N|   Lab and/or medical tests (such as genetic testing, MRI scans,||
2692|125|N|cognitive assessment) should be done before you start using this||
2692|126|N|medication and while you are using it. Keep all medical and lab||
2692|127|N|appointments.||
2692|128|B|||
2692|129|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember,||
2692|130|D|up to 6 days after the missed dose. Use your next dose on your||
2692|131|D|regular dosing schedule. Do not double the dose to catch up.||
2692|132|B|||
2692|133|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
2692|134|R|medication in the original packaging to protect from light. This||
2692|135|R|medication may also be stored at room temperature if needed. If||
2692|136|R|the medication is stored at room temperature, do not put it back||
2692|137|R|in the refrigerator and discard after 14 days. Keep all||
2692|138|R|medications away from children and pets.||
2692|139|R|   Do not flush medications down the toilet or pour them into a||
2692|140|R|drain unless instructed to do so. Properly discard this product||
2692|141|R|when it is expired or no longer needed. Consult your pharmacist||
2692|142|R|or local waste disposal company.||
2692|143|B|||
2692|144|A|Information last revised September 2025.||
2692|145|A|Copyright(c) 2025 First Databank, Inc.||
2692|146|B|||
2693|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2693|002|Z|does NOT have all possible information about this product. This||
2693|003|Z|information does not assure that this product is safe, effective,||
2693|004|Z|or appropriate for you. This information is not individual||
2693|005|Z|medical advice and does not substitute for the advice of your||
2693|006|Z|health care professional. Always ask your health care||
2693|007|Z|professional for complete information about this product and your||
2693|008|Z|specific health needs.||
2693|009|B|||
2693|010|T|APIXABAN TABLET - FOR ORAL SUSPENSION||
2693|011|F|(a-PIX-a-ban)||
2693|012|B|||
2693|013|C|COMMON BRAND NAME(S): Eliquis||
2693|014|B|||
2693|015|W|WARNING:  Do not stop apixaban unless directed by your child's||
2693|016|W|doctor. If you stop giving this medication early, your child has||
2693|017|W|a higher risk of forming a serious blood clot (such as stroke,||
2693|018|W|blood clot in the legs/lungs). The doctor may direct your child||
2693|019|W|to take a different "blood thinning" or antiplatelet medication||
2693|020|W|to reduce your child's risk. Get medical help right away if your||
2693|021|W|child has weakness on one side of the body, trouble speaking,||
2693|022|W|sudden vision changes, confusion, chest pain, trouble breathing,||
2693|023|W|or pain/warmth/swelling in the legs.||
2693|024|W|   People taking this medication may bleed near the spinal cord||
2693|025|W|after certain spinal procedures. Bleeding in this area can cause||
2693|026|W|paralysis that lasts a long time or could become permanent.||
2693|027|W|Before any spinal procedure, ask the doctor about the benefits||
2693|028|W|and risks. The risk of bleeding may be higher if your child has a||
2693|029|W|deformed spine, or has had spinal procedures/surgery before (such||
2693|030|W|as epidural catheter placement, difficult epidural/spinal||
2693|031|W|puncture), or if your child is taking other drugs that can cause||
2693|032|W|bleeding/bruising (including antiplatelet drugs such as||
2693|033|W|clopidogrel, "blood thinners" such as warfarin/enoxaparin,||
2693|034|W|nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen).||
2693|035|W|Tell the doctor right away if you notice symptoms such as back||
2693|036|W|pain, leg numbness/tingling/weakness, loss of control of the||
2693|037|W|bowels or bladder (incontinence).||
2693|038|B|||
2693|039|U|USES:  This form of apixaban is given to infants and children to||
2693|040|U|treat blood clots in the veins of the legs (deep vein thrombosis)||
2693|041|U|or lungs (pulmonary embolism) and to reduce the risk of them||
2693|042|U|occurring again. Apixaban is an anticoagulant that works by||
2693|043|U|blocking certain clotting proteins in the blood. This helps to||
2693|044|U|keep blood flowing smoothly in your child's body.||
2693|045|B|||
2693|046|H|HOW TO USE:  See also Warning section.||
2693|047|H|   Read the Medication Guide and, if available, the Instructions||
2693|048|H|for Use provided by the pharmacist before your child starts||
2693|049|H|apixaban and each time you get a refill. If you have any||
2693|050|H|questions, ask the doctor or pharmacist.||
2693|051|H|   This medication is taken by mouth with or without food as||
2693|052|H|directed by the doctor, usually twice daily (every 12 hours). The||
2693|053|H|dosage is based on your child's medical condition, weight, and||
2693|054|H|response to treatment (see also Notes section). This form of||
2693|055|H|apixaban must be mixed in liquid or applesauce before giving. Do||
2693|056|H|not swallow the tablets whole.||
2693|057|H|   If you are mixing with applesauce, open the prescribed number||
2693|058|H|of packets and add the tablet(s) to a bowl. Then add about 1||
2693|059|H|tablespoon (15 milliliters) of applesauce and stir. Give the||
2693|060|H|mixture right away until there is no medicine left in the bowl.||
2693|061|H|Throw away any unused applesauce mixture if it is not given right||
2693|062|H|away.||
2693|063|H|   If you are mixing in liquid, add the tablet(s) to a cup, then||
2693|064|H|add 2 teaspoons (10 milliliters) of liquid. Use either water,||
2693|065|H|infant formula, or apple juice. Do not use any other type of||
2693|066|H|liquid. Crush the tablets with a spoon and stir until you can no||
2693|067|H|longer see the medication in the liquid (about 5 to 7 minutes).||
2693|068|H|Give the mixture right away using a syringe. To make sure you||
2693|069|H|have given all of the medication, add another 1 teaspoon (5||
2693|070|H|milliliters) of liquid to the cup, stir, and give the rinse water||
2693|071|H|using the same syringe. Throw away any unused liquid mixture||
2693|072|H|after 2 hours. If your child has fluid restrictions, ask the||
2693|073|H|doctor how much liquid should be used to mix the medication.||
2693|074|H|Follow the doctor's instructions carefully.||
2693|075|H|   The tablets mixed in liquid may be given through a feeding||
2693|076|H|tube. If you are giving this medication through a feeding tube,||
2693|077|H|ask the health care professional for detailed instructions on how||
2693|078|H|to properly mix and give it.||
2693|079|H|   If your child vomits or spits up within 30 minutes after||
2693|080|H|taking a dose, give another dose at that time. If it is more than||
2693|081|H|30 minutes after taking a dose, do not give another dose. Give||
2693|082|H|the next dose at the regular time.||
2693|083|H|   Do not stop this medication without consulting the doctor.||
2693|084|H|Some conditions may become worse when this drug is suddenly||
2693|085|H|stopped. Do not run out of this medication. Order refills early||
2693|086|H|to avoid running out of medication.||
2693|087|H|   Use this medication regularly to get the most benefit from it.||
2693|088|H|To help you remember, give it at the same times each day.||
2693|089|H|   It is very important to give it exactly as directed. Do not||
2693|090|H|increase the dose or give this drug more often or for longer than||
2693|091|H|prescribed. Your child's condition will not improve any faster,||
2693|092|H|and the risk of serious side effects will increase.||
2693|093|B|||
2693|094|S|SIDE EFFECTS:  See also Warning section.||
2693|095|S|   Nausea, vomiting, headache, easy bruising, or minor bleeding||
2693|096|S|(such as nosebleed, bleeding from cuts) may occur. If any of||
2693|097|S|these effects last or get worse, tell the doctor or pharmacist||
2693|098|S|promptly.||
2693|099|S|   Remember that this medication has been prescribed because the||
2693|100|S|doctor has judged that the benefit to your child is greater than||
2693|101|S|the risk of side effects. Many people using this medication do||
2693|102|S|not have serious side effects.||
2693|103|S|   This medication can cause serious bleeding if it affects the||
2693|104|S|blood clotting proteins too much. Tell the doctor right away if||
2693|105|S|your child has any signs of serious bleeding, including:||
2693|106|S|nosebleeds that happen often or don't stop, unusual||
2693|107|S|tiredness/weakness, unusual pain/swelling/discomfort, unusual||
2693|108|S|bruising, prolonged bleeding from cuts or gums, unusually||
2693|109|S|heavy/prolonged menstrual flow, pink/dark urine, coughing up||
2693|110|S|blood, vomit that is bloody or looks like coffee grounds, severe||
2693|111|S|headache, dizziness/fainting, bloody/black/tarry stools,||
2693|112|S|difficulty swallowing.||
2693|113|S|   Get medical help right away if your child has any signs of||
2693|114|S|very serious bleeding, including: vision changes, confusion,||
2693|115|S|trouble speaking, weakness on one side of the body.||
2693|116|S|   A very serious allergic reaction to this drug is rare.||
2693|117|S|However, get medical help right away if you notice any symptoms||
2693|118|S|of a serious allergic reaction, including: rash, itching/swelling||
2693|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2693|120|S|breathing.||
2693|121|S|   This is not a complete list of possible side effects. If you||
2693|122|S|notice other effects not listed above, contact the doctor or||
2693|123|S|pharmacist.||
2693|124|S|   In the US -||
2693|125|S|   Call the doctor for medical advice about side effects. You may||
2693|126|S|report side effects to FDA at 1-800-FDA-1088 or at||
2693|127|S|www.fda.gov/medwatch.||
2693|128|S|   In Canada - Call the doctor for medical advice about side||
2693|129|S|effects. You may report side effects to Health Canada at||
2693|130|S|1-866-234-2345.||
2693|131|B|||
2693|132|P|PRECAUTIONS:  Before giving apixaban, tell the doctor or||
2693|133|P|pharmacist if your child is allergic to it; or if your child has||
2693|134|P|any other allergies. This product may contain inactive||
2693|135|P|ingredients, which can cause allergic reactions or other||
2693|136|P|problems. Talk to the pharmacist for more details.||
2693|137|P|   Before using this medication, tell the doctor or pharmacist||
2693|138|P|your child's medical history, especially of: liver disease,||
2693|139|P|kidney disease, bleeding problems (such as bleeding of the||
2693|140|P|stomach/intestines, bleeding in the brain), blood disorders (such||
2693|141|P|as anemia, hemophilia, thrombocytopenia), recent major||
2693|142|P|injury/surgery, stroke, a certain clotting disorder||
2693|143|P|(antiphospholipid syndrome), frequent falls/injuries.||
2693|144|P|   Before your child has surgery or any medical/dental procedures||
2693|145|P|(especially spinal puncture or spinal/epidural anesthesia), tell||
2693|146|P|the doctor or dentist that your child is taking this medication||
2693|147|P|and about all the products your child uses (including||
2693|148|P|prescription drugs, nonprescription drugs, and herbal products).||
2693|149|P|The doctor or dentist may tell you to stop giving apixaban before||
2693|150|P|the surgery. Ask for specific instructions about stopping or||
2693|151|P|starting this medication.||
2693|152|P|   This medication may cause stomach bleeding. Daily use of||
2693|153|P|alcohol while using this medicine may increase the risk for||
2693|154|P|stomach bleeding. Avoid alcoholic beverages.||
2693|155|P|   This medication can cause heavy bleeding. To lower the chance||
2693|156|P|of getting cut, bruised, or injured, use caution with sharp||
2693|157|P|objects like razors and nail cutters, and avoid activities such||
2693|158|P|as contact sports. Your child should use an electric razor when||
2693|159|P|shaving and a soft toothbrush when brushing their teeth. If your||
2693|160|P|child falls or is injured, especially if your child hits their||
2693|161|P|head, call the doctor right away. The doctor may need to check||
2693|162|P|your child.||
2693|163|P|   This form of apixaban is not usually used by adults. It is||
2693|164|P|unlikely to be used during pregnancy or breastfeeding. Consult||
2693|165|P|the doctor if you have any questions about this medication.||
2693|166|B|||
2693|167|I|DRUG INTERACTIONS:  See also Warning section.||
2693|168|I|   Drug interactions may change how your medications work or||
2693|169|I|increase your risk for serious side effects. This document does||
2693|170|I|not contain all possible drug interactions. Keep a list of all||
2693|171|I|the products you use (including prescription/nonprescription||
2693|172|I|drugs and herbal products) and share it with your doctor and||
2693|173|I|pharmacist. Do not start, stop, or change the dosage of any||
2693|174|I|medicines without your doctor's approval.||
2693|175|I|   Some products that may interact with this drug are:||
2693|176|I|mifepristone, other drugs that can cause bleeding/bruising||
2693|177|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
2693|178|I|ibuprofen/naproxen, "blood thinners" such as||
2693|179|I|warfarin/enoxaparin), certain antidepressants (including SSRIs||
2693|180|I|such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine).||
2693|181|I|   Other medications can affect the removal of apixaban from your||
2693|182|I|child's body, which may affect how apixaban works. Examples||
2693|183|I|include apalutamide, certain azole antifungals (such as||
2693|184|I|itraconazole, ketoconazole, posaconazole), conivaptan, HIV||
2693|185|I|protease inhibitors (such as lopinavir), rifamycins (such as||
2693|186|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
2693|187|I|seizures (such as carbamazepine, phenobarbital, phenytoin), among||
2693|188|I|others.||
2693|189|I|   Aspirin can increase the risk of bleeding when used with this||
2693|190|I|medication. However, if the doctor has told you to give aspirin,||
2693|191|I|your child should keep taking the aspirin unless the doctor tells||
2693|192|I|you not to. Ask the doctor or pharmacist for more details.||
2693|193|B|||
2693|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2693|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2693|196|O|poison control center right away. US residents can call||
2693|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2693|198|O|Symptoms of overdose may include: bloody/black/tarry stools,||
2693|199|O|pink/dark urine, unusual/prolonged bleeding.||
2693|200|B|||
2693|201|N|NOTES:  Do not share this medication with others.||
2693|202|N|   Lab and/or medical tests (such as hematocrit/hemoglobin, red||
2693|203|N|blood cell count, weight monitoring) may be done while your child||
2693|204|N|is taking this medication. Keep all medical and lab appointments.||
2693|205|N|Tell the doctor about any weight changes. The doctor may need to||
2693|206|N|adjust your child's dose. Consult the doctor for more details.||
2693|207|B|||
2693|208|D|MISSED DOSE:  If your child misses a dose, give it as soon as you||
2693|209|D|remember if it is on the same day. Give the next dose at the||
2693|210|D|regular time. Do not double the dose to catch up.||
2693|211|B|||
2693|212|R|STORAGE:  Store at room temperature away from light and moisture.||
2693|213|R|Do not store in the bathroom. Keep all medications away from||
2693|214|R|children and pets.||
2693|215|R|   Do not flush medications down the toilet or pour them into a||
2693|216|R|drain unless instructed to do so. Properly discard this product||
2693|217|R|when it is expired or no longer needed. Consult your pharmacist||
2693|218|R|or local waste disposal company.||
2693|219|B|||
2693|220|M|MEDICAL ALERT:  Your child's condition can cause complications in||
2693|221|M|a medical emergency. For information about enrolling in||
2693|222|M|MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2693|223|B|||
2693|224|A|Information last revised September 2025.||
2693|225|A|Copyright(c) 2025 First Databank, Inc.||
2693|226|B|||
2694|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2694|002|Z|does NOT have all possible information about this product. This||
2694|003|Z|information does not assure that this product is safe, effective,||
2694|004|Z|or appropriate for you. This information is not individual||
2694|005|Z|medical advice and does not substitute for the advice of your||
2694|006|Z|health care professional. Always ask your health care||
2694|007|Z|professional for complete information about this product and your||
2694|008|Z|specific health needs.||
2694|009|B|||
2694|010|T|APIXABAN SPRINKLE CAPSULE - ORAL||
2694|011|F|(a-PIX-a-ban)||
2694|012|B|||
2694|013|C|COMMON BRAND NAME(S): Eliquis Sprinkle||
2694|014|B|||
2694|015|W|WARNING:  Do not stop apixaban unless directed by your child's||
2694|016|W|doctor. If you stop giving this medication early, your child has||
2694|017|W|a higher risk of forming a serious blood clot (such as stroke,||
2694|018|W|blood clot in the legs/lungs). The doctor may direct your child||
2694|019|W|to take a different "blood thinning" or antiplatelet medication||
2694|020|W|to reduce your child's risk. Get medical help right away if your||
2694|021|W|child has weakness on one side of the body, trouble speaking,||
2694|022|W|sudden vision changes, confusion, chest pain, trouble breathing,||
2694|023|W|or pain/warmth/swelling in the legs.||
2694|024|W|   People taking this medication may bleed near the spinal cord||
2694|025|W|after certain spinal procedures. Bleeding in this area can cause||
2694|026|W|paralysis that lasts a long time or could become permanent.||
2694|027|W|Before any spinal procedure, ask the doctor about the benefits||
2694|028|W|and risks. The risk of bleeding may be higher if your child has a||
2694|029|W|deformed spine, or has had spinal procedures/surgery before (such||
2694|030|W|as epidural catheter placement, difficult epidural/spinal||
2694|031|W|puncture), or if your child is taking other drugs that can cause||
2694|032|W|bleeding/bruising (including antiplatelet drugs such as||
2694|033|W|clopidogrel, "blood thinners" such as warfarin/enoxaparin,||
2694|034|W|nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen).||
2694|035|W|Tell the doctor right away if you notice symptoms such as back||
2694|036|W|pain, leg numbness/tingling/weakness, loss of control of the||
2694|037|W|bowels or bladder (incontinence).||
2694|038|B|||
2694|039|U|USES:  This form of apixaban is given to infants to treat blood||
2694|040|U|clots in the veins of the legs (deep vein thrombosis) or lungs||
2694|041|U|(pulmonary embolism) and to reduce the risk of them occurring||
2694|042|U|again. Apixaban is an anticoagulant that works by blocking||
2694|043|U|certain clotting proteins in the blood. This helps to keep blood||
2694|044|U|flowing smoothly in your child's body.||
2694|045|B|||
2694|046|H|HOW TO USE:  See also Warning section.||
2694|047|H|   Read the Medication Guide and, if available, the Instructions||
2694|048|H|for Use provided by the pharmacist before your child starts||
2694|049|H|apixaban and each time you get a refill. If you have any||
2694|050|H|questions, ask the doctor or pharmacist.||
2694|051|H|   This medication is taken by mouth with or without food as||
2694|052|H|directed by the doctor, usually twice daily (every 12 hours). The||
2694|053|H|dosage is based on your child's medical condition, weight, and||
2694|054|H|response to treatment (see also Notes section).||
2694|055|H|   Do not swallow the capsules whole. Open the capsule(s) and||
2694|056|H|sprinkle the entire contents into a cup. Add 1 teaspoon (5||
2694|057|H|milliliters) of liquid. Use either water or infant formula. Do||
2694|058|H|not use any other type of liquid. Stir until you can no longer||
2694|059|H|see the medication in the liquid. Give the mixture right away||
2694|060|H|using a syringe. To make sure you have given all of the||
2694|061|H|medication, add another 1 teaspoon (5 milliliters) of liquid to||
2694|062|H|the cup, stir, and give the rinse water using the same syringe.||
2694|063|H|Throw away any unused liquid mixture after 2 hours. If your child||
2694|064|H|has fluid restrictions, ask the doctor how much liquid should be||
2694|065|H|used to mix the medication. Follow your doctor's instructions||
2694|066|H|carefully.||
2694|067|H|   If your child vomits or spits up within 30 minutes after||
2694|068|H|taking a dose, give another dose at that time. If it is more than||
2694|069|H|30 minutes after taking a dose, do not give another dose. Give||
2694|070|H|the next dose at the regular time.||
2694|071|H|   Do not stop this medication without consulting the doctor.||
2694|072|H|Some conditions may become worse when this drug is suddenly||
2694|073|H|stopped. Do not run out of this medication. Order refills early||
2694|074|H|to avoid running out of medication.||
2694|075|H|   Use this medication regularly to get the most benefit from it.||
2694|076|H|To help you remember, give it at the same times each day.||
2694|077|H|   It is very important to give it exactly as directed. Do not||
2694|078|H|increase the dose or give this drug more often or for longer than||
2694|079|H|prescribed. Your child's condition will not improve any faster,||
2694|080|H|and the risk of serious side effects will increase.||
2694|081|B|||
2694|082|S|SIDE EFFECTS:  See also Warning section.||
2694|083|S|   Nausea, vomiting, headache, easy bruising, or minor bleeding||
2694|084|S|(such as nosebleed, bleeding from cuts) may occur. If any of||
2694|085|S|these effects last or get worse, tell the doctor or pharmacist||
2694|086|S|promptly.||
2694|087|S|   Remember that this medication has been prescribed because the||
2694|088|S|doctor has judged that the benefit to your child is greater than||
2694|089|S|the risk of side effects. Many people using this medication do||
2694|090|S|not have serious side effects.||
2694|091|S|   This medication can cause serious bleeding if it affects the||
2694|092|S|blood clotting proteins too much. Tell the doctor right away if||
2694|093|S|your child has any signs of serious bleeding, including:||
2694|094|S|nosebleeds that happen often or don't stop, unusual||
2694|095|S|tiredness/weakness, unusual pain/swelling/discomfort, unusual||
2694|096|S|bruising, prolonged bleeding from cuts or gums, unusually||
2694|097|S|heavy/prolonged menstrual flow, pink/dark urine, coughing up||
2694|098|S|blood, vomit that is bloody or looks like coffee grounds, severe||
2694|099|S|headache, dizziness/fainting, bloody/black/tarry stools,||
2694|100|S|difficulty swallowing.||
2694|101|S|   Get medical help right away if your child has any signs of||
2694|102|S|very serious bleeding, including: vision changes, confusion,||
2694|103|S|trouble speaking, weakness on one side of the body.||
2694|104|S|   A very serious allergic reaction to this drug is rare.||
2694|105|S|However, get medical help right away if you notice any symptoms||
2694|106|S|of a serious allergic reaction, including: rash, itching/swelling||
2694|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2694|108|S|breathing.||
2694|109|S|   This is not a complete list of possible side effects. If you||
2694|110|S|notice other effects not listed above, contact the doctor or||
2694|111|S|pharmacist.||
2694|112|S|   In the US -||
2694|113|S|   Call your doctor for medical advice about side effects. You||
2694|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2694|115|S|www.fda.gov/medwatch.||
2694|116|S|   In Canada - Call your doctor for medical advice about side||
2694|117|S|effects. You may report side effects to Health Canada at||
2694|118|S|1-866-234-2345.||
2694|119|B|||
2694|120|P|PRECAUTIONS:  Before giving apixaban, tell the doctor or||
2694|121|P|pharmacist if your child is allergic to it; or if your child has||
2694|122|P|any other allergies. This product may contain inactive||
2694|123|P|ingredients, which can cause allergic reactions or other||
2694|124|P|problems. Talk to the pharmacist for more details.||
2694|125|P|   Before using this medication, tell the doctor or pharmacist||
2694|126|P|your child's medical history, especially of: liver disease,||
2694|127|P|kidney disease, bleeding problems (such as bleeding of the||
2694|128|P|stomach/intestines, bleeding in the brain), blood disorders (such||
2694|129|P|as anemia, hemophilia, thrombocytopenia), recent major||
2694|130|P|injury/surgery, stroke, a certain clotting disorder||
2694|131|P|(antiphospholipid syndrome), frequent falls/injuries.||
2694|132|P|   Before your child has surgery or any medical/dental procedures||
2694|133|P|(especially spinal puncture or spinal/epidural anesthesia), tell||
2694|134|P|the doctor or dentist that your child is taking this medication||
2694|135|P|and about all the products your child uses (including||
2694|136|P|prescription drugs, nonprescription drugs, and herbal products).||
2694|137|P|The doctor or dentist may tell you to stop giving apixaban before||
2694|138|P|the surgery. Ask for specific instructions about stopping or||
2694|139|P|starting this medication.||
2694|140|P|   This medication may cause stomach bleeding. Daily use of||
2694|141|P|alcohol while using this medicine may increase the risk for||
2694|142|P|stomach bleeding. Avoid alcoholic beverages.||
2694|143|P|   This medication can cause heavy bleeding. To lower the chance||
2694|144|P|of getting cut, bruised, or injured, use caution with sharp||
2694|145|P|objects like razors and nail cutters, and avoid activities such||
2694|146|P|as contact sports. Your child should use an electric razor when||
2694|147|P|shaving and a soft toothbrush when brushing their teeth. If your||
2694|148|P|child falls or is injured, especially if your child hits their||
2694|149|P|head, call the doctor right away. The doctor may need to check||
2694|150|P|your child.||
2694|151|P|   This form of apixaban is not usually used by adults. It is||
2694|152|P|unlikely to be used during pregnancy or breastfeeding. Consult||
2694|153|P|the doctor if you have any questions about this medication.||
2694|154|B|||
2694|155|I|DRUG INTERACTIONS:  See also Warning section.||
2694|156|I|   Drug interactions may change how your medications work or||
2694|157|I|increase your risk for serious side effects. This document does||
2694|158|I|not contain all possible drug interactions. Keep a list of all||
2694|159|I|the products you use (including prescription/nonprescription||
2694|160|I|drugs and herbal products) and share it with your doctor and||
2694|161|I|pharmacist. Do not start, stop, or change the dosage of any||
2694|162|I|medicines without your doctor's approval.||
2694|163|I|   Some products that may interact with this drug are:||
2694|164|I|mifepristone, other drugs that can cause bleeding/bruising||
2694|165|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
2694|166|I|ibuprofen/naproxen, "blood thinners" such as||
2694|167|I|warfarin/enoxaparin), certain antidepressants (including SSRIs||
2694|168|I|such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine).||
2694|169|I|   Other medications can affect the removal of apixaban from your||
2694|170|I|child's body, which may affect how apixaban works. Examples||
2694|171|I|include apalutamide, certain azole antifungals (such as||
2694|172|I|itraconazole, ketoconazole, posaconazole), conivaptan, HIV||
2694|173|I|protease inhibitors (such as lopinavir), rifamycins (such as||
2694|174|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
2694|175|I|seizures (such as carbamazepine, phenobarbital, phenytoin), among||
2694|176|I|others.||
2694|177|I|   Aspirin can increase the risk of bleeding when used with this||
2694|178|I|medication. However, if the doctor has told you to give aspirin,||
2694|179|I|your child should keep taking the aspirin unless the doctor tells||
2694|180|I|you not to. Ask the doctor or pharmacist for more details.||
2694|181|B|||
2694|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2694|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2694|184|O|poison control center right away. US residents can call||
2694|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2694|186|O|Symptoms of overdose may include: bloody/black/tarry stools,||
2694|187|O|pink/dark urine, unusual/prolonged bleeding.||
2694|188|B|||
2694|189|N|NOTES:  Do not share this medication with others.||
2694|190|N|   Lab and/or medical tests (such as hematocrit/hemoglobin, red||
2694|191|N|blood cell count, weight monitoring) may be done while your child||
2694|192|N|is taking this medication. Keep all medical and lab appointments.||
2694|193|N|Tell the doctor about any weight changes. The doctor may need to||
2694|194|N|adjust your child's dose. Consult the doctor for more details.||
2694|195|B|||
2694|196|D|MISSED DOSE:  If your child misses a dose, give it as soon as you||
2694|197|D|remember if it is on the same day. Give the next dose at the||
2694|198|D|regular time. Do not double the dose to catch up.||
2694|199|B|||
2694|200|R|STORAGE:  Store at room temperature away from light and moisture.||
2694|201|R|Do not store in the bathroom. Keep all medications away from||
2694|202|R|children and pets.||
2694|203|R|   Do not flush medications down the toilet or pour them into a||
2694|204|R|drain unless instructed to do so. Properly discard this product||
2694|205|R|when it is expired or no longer needed. Consult your pharmacist||
2694|206|R|or local waste disposal company.||
2694|207|B|||
2694|208|M|MEDICAL ALERT:  Your child's condition can cause complications in||
2694|209|M|a medical emergency. For information about enrolling in||
2694|210|M|MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2694|211|B|||
2694|212|A|Information last revised September 2025.||
2694|213|A|Copyright(c) 2025 First Databank, Inc.||
2694|214|B|||
2695|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2695|002|Z|does NOT have all possible information about this product. This||
2695|003|Z|information does not assure that this product is safe, effective,||
2695|004|Z|or appropriate for you. This information is not individual||
2695|005|Z|medical advice and does not substitute for the advice of your||
2695|006|Z|health care professional. Always ask your health care||
2695|007|Z|professional for complete information about this product and your||
2695|008|Z|specific health needs.||
2695|009|B|||
2695|010|T|GEMCITABINE IMPLANT- INTRAVESICAL||
2695|011|F|(jem-SYE-ta-been)||
2695|012|B|||
2695|013|C|COMMON BRAND NAME(S): Inlexzo||
2695|014|B|||
2695|015|U|USES:  This medication implant is used to treat a certain type of||
2695|016|U|cancer (bladder cancer). It works by slowing or stopping the||
2695|017|U|growth of cancer cells.||
2695|018|B|||
2695|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2695|020|H|from your pharmacist before you start using gemcitabine and each||
2695|021|H|time you get a treatment. If you have any questions, ask your||
2695|022|H|doctor or pharmacist.||
2695|023|H|   This medication is an implant that is inserted into the||
2695|024|H|bladder through a tube (catheter) by a health care professional.||
2695|025|H|Do not empty your bladder right before the implant is inserted.||
2695|026|H|Your doctor may prescribe other medications (such as antibiotics)||
2695|027|H|before inserting or removing the implant. Follow your doctor's||
2695|028|H|directions carefully.||
2695|029|H|   The implant is inserted as directed by your doctor, usually||
2695|030|H|every 3 weeks or every 12 weeks. The treatment schedule is based||
2695|031|H|on your medical condition and response to treatment. The implant||
2695|032|H|is usually left in the bladder for 3 weeks, then removed by a||
2695|033|H|health care provider.||
2695|034|H|   After the implant is inserted, drink 6 to 7 cups (1500||
2695|035|H|milliliters) of fluids every day unless otherwise directed by||
2695|036|H|your doctor. Doing so helps the medication work better. You may||
2695|037|H|urinate normally after the implant is inserted.||
2695|038|H|   After the implant has been placed, be careful to avoid contact||
2695|039|H|with your urine during treatment and for 24 hours after the||
2695|040|H|implant is removed. This drug can be absorbed through the skin||
2695|041|H|and may harm you. To avoid splashing, sit down on the toilet seat||
2695|042|H|each time you urinate. When you are done, flush the toilet.||
2695|043|H|Afterward, wash your hands and genital area well with soap and||
2695|044|H|water. If any urine comes into contact with your clothing, the||
2695|045|H|clothing should be washed right away and separately from your||
2695|046|H|other clothing.||
2695|047|H|   Your health care provider should give you an implant card||
2695|048|H|after you receive the implant. Keep the card in a safe place and||
2695|049|H|show it to all your health care provider(s). You may only receive||
2695|050|H|an MRI under very specific conditions if you have this implant.||
2695|051|B|||
2695|052|S|SIDE EFFECTS:  Difficult/frequent urination may occur. If this||
2695|053|S|effect lasts or gets worse, tell your doctor or pharmacist||
2695|054|S|promptly.||
2695|055|S|   Remember that this medication has been prescribed because your||
2695|056|S|doctor has judged that the benefit to you is greater than the||
2695|057|S|risk of side effects. Many people using this medication do not||
2695|058|S|have serious side effects.||
2695|059|S|   Tell your doctor right away if you have any serious side||
2695|060|S|effects, including: pink/bloody urine, low back/side pain (flank||
2695|061|S|pain), signs of infection (such as sore throat that doesn't go||
2695|062|S|away, fever, chills, painful urination), signs of anemia (such as||
2695|063|S|unusual tiredness, rapid breathing, pale skin, shortness of||
2695|064|S|breath, fast heartbeat).||
2695|065|S|   A very serious allergic reaction to this drug is rare.||
2695|066|S|However, get medical help right away if you notice any symptoms||
2695|067|S|of a serious allergic reaction, including: rash, itching/swelling||
2695|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2695|069|S|breathing.||
2695|070|S|   This is not a complete list of possible side effects. If you||
2695|071|S|notice other effects not listed above, contact your doctor or||
2695|072|S|pharmacist.||
2695|073|S|   In the US -||
2695|074|S|   Call your doctor for medical advice about side effects. You||
2695|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2695|076|S|www.fda.gov/medwatch.||
2695|077|S|   In Canada - Call your doctor for medical advice about side||
2695|078|S|effects. You may report side effects to Health Canada at||
2695|079|S|1-866-234-2345.||
2695|080|B|||
2695|081|P|PRECAUTIONS:  Before using gemcitabine, tell your doctor or||
2695|082|P|pharmacist if you are allergic to it; or if you have any other||
2695|083|P|allergies. This product may contain inactive ingredients, which||
2695|084|P|can cause allergic reactions or other problems. Talk to your||
2695|085|P|pharmacist for more details.||
2695|086|P|   Before using this medication, tell your doctor or pharmacist||
2695|087|P|your medical history, especially of: a hole in the bladder||
2695|088|P|(perforation).||
2695|089|P|   Before having surgery, tell your doctor or dentist about all||
2695|090|P|the products you use (including prescription drugs,||
2695|091|P|nonprescription drugs, and herbal products).||
2695|092|P|   Tell your doctor if you are pregnant or plan to become||
2695|093|P|pregnant. You should not become pregnant while using gemcitabine.||
2695|094|P|Gemcitabine may harm an unborn baby. Your doctor should order a||
2695|095|P|pregnancy test before you start this medication. Women using this||
2695|096|P|medication should ask about reliable forms of birth control||
2695|097|P|during treatment and for 6 months after the implant is removed.||
2695|098|P|Men using this medication should ask about reliable forms of||
2695|099|P|birth control during treatment and for 3 months after the implant||
2695|100|P|is removed. If you or your partner becomes pregnant, talk to your||
2695|101|P|doctor right away about the risks and benefits of this||
2695|102|P|medication.||
2695|103|P|   It is unknown if this drug passes into breast milk. Because of||
2695|104|P|the possible risk to the infant, breastfeeding is not recommended||
2695|105|P|while using this drug and for 1 week after the implant is||
2695|106|P|removed. Consult your doctor before breastfeeding.||
2695|107|B|||
2695|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2695|109|I|medications work or increase your risk for serious side effects.||
2695|110|I|This document does not contain all possible drug interactions.||
2695|111|I|Keep a list of all the products you use (including||
2695|112|I|prescription/nonprescription drugs and herbal products) and share||
2695|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
2695|114|I|the dosage of any medicines without your doctor's approval.||
2695|115|B|||
2695|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2695|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2695|118|O|poison control center right away. US residents can call||
2695|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2695|120|B|||
2695|121|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
2695|122|N|should be done while you are using this medication. Keep all||
2695|123|N|medical and lab appointments. Consult your doctor for more||
2695|124|N|details.||
2695|125|B|||
2695|126|D|MISSED DOSE:  It is important to get each dose of this medication||
2695|127|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2695|128|D|right away for a new dosing schedule.||
2695|129|B|||
2695|130|R|STORAGE:  Not applicable. This medication is given in a hospital||
2695|131|R|or clinic and will not be stored at home.||
2695|132|B|||
2695|133|A|Information last revised September 2025.||
2695|134|A|Copyright(c) 2025 First Databank, Inc.||
2695|135|B|||
2696|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2696|002|Z|does NOT have all possible information about this product. This||
2696|003|Z|information does not assure that this product is safe, effective,||
2696|004|Z|or appropriate for you. This information is not individual||
2696|005|Z|medical advice and does not substitute for the advice of your||
2696|006|Z|health care professional. Always ask your health care||
2696|007|Z|professional for complete information about this product and your||
2696|008|Z|specific health needs.||
2696|009|B|||
2696|010|T|APREMILAST EXTENDED-RELEASE - ORAL||
2696|011|F|(a-PRE-mi-last)||
2696|012|B|||
2696|013|C|COMMON BRAND NAME(S): Otezla XR||
2696|014|B|||
2696|015|U|USES:  This medication is used to treat a certain type of||
2696|016|U|arthritis (psoriatic arthritis). Apremilast is also used to treat||
2696|017|U|a certain type of skin condition (moderate to severe plaque||
2696|018|U|psoriasis). Apremilast belongs to a class of drugs known as||
2696|019|U|phosphodiesterase 4 (PDE4) inhibitors. For the treatment of||
2696|020|U|psoriatic arthritis, it decreases pain and swelling, and may help||
2696|021|U|improve flexibility in the affected joints. For the treatment of||
2696|022|U|plaque psoriasis, it may help to reduce the redness, thickening,||
2696|023|U|and scaling of the skin that occurs with this condition.||
2696|024|U|   Apremilast is also used to treat mouth sores in people who||
2696|025|U|have Behcet's disease. It helps to reduce the pain and improve||
2696|026|U|the healing of these mouth sores.||
2696|027|B|||
2696|028|H|HOW TO USE:  Take this medication by mouth with or without food||
2696|029|H|as directed by your doctor, usually once daily. Swallow the||
2696|030|H|tablets whole. Do not crush, split, or chew the tablets. Doing so||
2696|031|H|can release all of the drug at once, increasing the risk of side||
2696|032|H|effects.||
2696|033|H|   The dosage is based on your medical condition and response to||
2696|034|H|treatment. Children's dosage is also based on weight.||
2696|035|H|   To reduce your risk of side effects, your doctor may direct||
2696|036|H|you to start this medication at a low dose and gradually increase||
2696|037|H|your dose. Follow your doctor's instructions carefully.||
2696|038|H|Apremilast is also available in another formulation||
2696|039|H|(immediate-release tablets). Do not switch between different||
2696|040|H|forms of apremilast unless your doctor tells you to.||
2696|041|H|   Use this medication regularly to get the most benefit from it.||
2696|042|H|To help you remember, take it at the same time each day.||
2696|043|H|   Tell your doctor if your condition does not get better or if||
2696|044|H|it gets worse.||
2696|045|B|||
2696|046|S|SIDE EFFECTS:  Diarrhea, nausea/vomiting, loss of appetite,||
2696|047|S|headache, or weight loss may occur. If any of these effects last||
2696|048|S|or get worse, tell your doctor or pharmacist promptly.||
2696|049|S|   An empty tablet shell may appear in your stool. This effect is||
2696|050|S|harmless because your body has already absorbed the medication.||
2696|051|S|   Remember that this medication has been prescribed because your||
2696|052|S|doctor has judged that the benefit to you is greater than the||
2696|053|S|risk of side effects. Many people using this medication do not||
2696|054|S|have serious side effects.||
2696|055|S|   Tell your doctor right away if you have any serious side||
2696|056|S|effects, including: severe nausea/vomiting/diarrhea.||
2696|057|S|   Rarely, people who take this medication may experience||
2696|058|S|depression, suicidal thoughts/attempts, or other mental/mood||
2696|059|S|problems. Tell your doctor right away if you or your||
2696|060|S|family/caregiver notice any unusual/sudden changes in your mood,||
2696|061|S|thoughts, or behavior including signs of depression, suicidal||
2696|062|S|thoughts/attempts, thoughts about harming yourself.||
2696|063|S|   A very serious allergic reaction to this drug is rare.||
2696|064|S|However, get medical help right away if you notice any symptoms||
2696|065|S|of a serious allergic reaction, including: rash, itching/swelling||
2696|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2696|067|S|breathing.||
2696|068|S|   This is not a complete list of possible side effects. If you||
2696|069|S|notice other effects not listed above, contact your doctor or||
2696|070|S|pharmacist.||
2696|071|S|   In the US -||
2696|072|S|   Call your doctor for medical advice about side effects. You||
2696|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2696|074|S|www.fda.gov/medwatch.||
2696|075|S|   In Canada - Call your doctor for medical advice about side||
2696|076|S|effects. You may report side effects to Health Canada at||
2696|077|S|1-866-234-2345.||
2696|078|B|||
2696|079|P|PRECAUTIONS:  Before taking apremilast, tell your doctor or||
2696|080|P|pharmacist if you are allergic to it; or if you have any other||
2696|081|P|allergies. This product may contain inactive ingredients, which||
2696|082|P|can cause allergic reactions or other problems. Talk to your||
2696|083|P|pharmacist for more details.||
2696|084|P|   Before using this medication, tell your doctor or pharmacist||
2696|085|P|your medical history, especially of: kidney disease, mental/mood||
2696|086|P|disorders (such as depression).||
2696|087|P|   Before having surgery, tell your doctor or dentist about all||
2696|088|P|the products you use (including prescription drugs,||
2696|089|P|nonprescription drugs, and herbal products).||
2696|090|P|   During pregnancy, this medication should be used only when||
2696|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
2696|092|P|   It is unknown if this medication passes into breast milk.||
2696|093|P|Consult your doctor before breastfeeding.||
2696|094|B|||
2696|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2696|096|I|medications work or increase your risk for serious side effects.||
2696|097|I|This document does not contain all possible drug interactions.||
2696|098|I|Keep a list of all the products you use (including||
2696|099|I|prescription/nonprescription drugs and herbal products) and share||
2696|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
2696|101|I|the dosage of any medicines without your doctor's approval.||
2696|102|I|   Other medications can affect the removal of apremilast from||
2696|103|I|your body, which may affect how apremilast works. Examples||
2696|104|I|include certain drugs used to treat seizures (such as||
2696|105|I|carbamazepine, phenobarbital, phenytoin, primidone), rifamycins||
2696|106|I|(such as rifampin, rifabutin), among others.||
2696|107|B|||
2696|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2696|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2696|110|O|poison control center right away. US residents can call||
2696|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2696|112|B|||
2696|113|N|NOTES:  Do not share this medication with others.||
2696|114|N|   Since this medication can cause weight loss, check your weight||
2696|115|N|regularly while taking this drug. Tell your doctor of any unusual||
2696|116|N|weight loss. Children should also see their doctor regularly so||
2696|117|N|that their height, weight, and growth can be checked.||
2696|118|B|||
2696|119|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2696|120|D|remember. If it is near the time of the next dose, skip the||
2696|121|D|missed dose. Take your next dose at the regular time. Do not||
2696|122|D|double the dose to catch up.||
2696|123|B|||
2696|124|R|STORAGE:  Store at room temperature away from light and moisture.||
2696|125|R|Do not store in the bathroom. Keep all medications away from||
2696|126|R|children and pets.||
2696|127|R|   Do not flush medications down the toilet or pour them into a||
2696|128|R|drain unless instructed to do so. Properly discard this product||
2696|129|R|when it is expired or no longer needed. Consult your pharmacist||
2696|130|R|or local waste disposal company.||
2696|131|B|||
2696|132|A|Information last revised October 2025.||
2696|133|A|Copyright(c) 2025 First Databank, Inc.||
2696|134|B|||
2697|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2697|002|Z|does NOT have all possible information about this product. This||
2697|003|Z|information does not assure that this product is safe, effective,||
2697|004|Z|or appropriate for you. This information is not individual||
2697|005|Z|medical advice and does not substitute for the advice of your||
2697|006|Z|health care professional. Always ask your health care||
2697|007|Z|professional for complete information about this product and your||
2697|008|Z|specific health needs.||
2697|009|B|||
2697|010|T|GEPIRONE EXTENDED-RELEASE - ORAL||
2697|011|F|(je-PYE-rone)||
2697|012|B|||
2697|013|C|COMMON BRAND NAME(S): Exxua||
2697|014|B|||
2697|015|W|WARNING:  Antidepressant medications are used to treat a variety||
2697|016|W|of conditions, including depression and other mental/mood||
2697|017|W|disorders. These medications can help prevent suicidal||
2697|018|W|thoughts/attempts and provide other important benefits. However,||
2697|019|W|studies have shown that a small number of people (especially||
2697|020|W|people younger than 25) who take antidepressants for any||
2697|021|W|condition may experience worsening depression, other mental/mood||
2697|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
2697|023|W|talk with the doctor about the risks and benefits of||
2697|024|W|antidepressant medication (especially for people younger than||
2697|025|W|25), even if treatment is not for a mental/mood condition.||
2697|026|W|   Tell the doctor right away if you notice worsening||
2697|027|W|depression/other psychiatric conditions, unusual behavior changes||
2697|028|W|(including possible suicidal thoughts/attempts), or other||
2697|029|W|mental/mood changes (including new/worsening anxiety, panic||
2697|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
2697|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
2697|032|W|especially watchful for these symptoms when a new antidepressant||
2697|033|W|is started or when the dose is changed.||
2697|034|B|||
2697|035|U|USES:  This medication is used to treat depression. Gepirone||
2697|036|U|works by helping to restore the balance of certain natural||
2697|037|U|substances in the brain.||
2697|038|B|||
2697|039|H|HOW TO USE:  Read the Medication Guide provided by your||
2697|040|H|pharmacist before you start using gepirone and each time you get||
2697|041|H|a refill. If you have any questions, ask your doctor or||
2697|042|H|pharmacist.||
2697|043|H|   Take this medication by mouth with food as directed by your||
2697|044|H|doctor, usually once daily. Swallow the tablets whole. Do not||
2697|045|H|split, crush, or chew the tablets. Doing so can release all of||
2697|046|H|the drug at once, increasing the risk of side effects.||
2697|047|H|   The dosage is based on your medical condition, age, response||
2697|048|H|to treatment, and other medications you may be taking. Be sure to||
2697|049|H|tell your doctor and pharmacist about all the products you use||
2697|050|H|(including prescription drugs, nonprescription drugs, and herbal||
2697|051|H|products). To reduce your risk of side effects, your doctor may||
2697|052|H|direct you to start this medication at a low dose and gradually||
2697|053|H|increase your dose. Follow your doctor's instructions carefully.||
2697|054|H|   Use this medication regularly to get the most benefit from it.||
2697|055|H|To help you remember, take it at the same time each day.||
2697|056|H|   Keep taking this medication even if you feel well. Do not stop||
2697|057|H|taking this medication without consulting your doctor. Some||
2697|058|H|conditions may become worse when this drug is suddenly stopped.||
2697|059|H|Your dose may need to be gradually decreased.||
2697|060|H|   Tell your doctor if your condition does not get better or if||
2697|061|H|it gets worse.||
2697|062|B|||
2697|063|S|SIDE EFFECTS:  See also Warning section.||
2697|064|S|   Dizziness, nausea/vomiting, stomach/abdominal pain, stomach||
2697|065|S|upset, dry mouth, or increased sweating may occur. If any of||
2697|066|S|these effects last or get worse, tell your doctor or pharmacist||
2697|067|S|promptly.||
2697|068|S|   Remember that this medication has been prescribed because your||
2697|069|S|doctor has judged that the benefit to you is greater than the||
2697|070|S|risk of side effects. Many people using this medication do not||
2697|071|S|have serious side effects.||
2697|072|S|   Tell your doctor right away if you have any serious side||
2697|073|S|effects, including: numb/tingling skin.||
2697|074|S|   Get medical help right away if you have any very serious side||
2697|075|S|effects, including: fast/irregular heartbeat, severe dizziness,||
2697|076|S|fainting.||
2697|077|S|   This medication may increase serotonin and rarely cause a very||
2697|078|S|serious condition called serotonin syndrome/toxicity. The risk||
2697|079|S|increases if you are also taking other drugs that increase||
2697|080|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
2697|081|S|take (see Drug Interactions section). Get medical help right away||
2697|082|S|if you develop some of the following symptoms: fast heartbeat,||
2697|083|S|hallucinations, loss of coordination, severe dizziness, severe||
2697|084|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
2697|085|S|unusual agitation/restlessness.||
2697|086|S|   A very serious allergic reaction to this drug is rare.||
2697|087|S|However, get medical help right away if you notice any symptoms||
2697|088|S|of a serious allergic reaction, including: rash, itching/swelling||
2697|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2697|090|S|breathing.||
2697|091|S|   This is not a complete list of possible side effects. If you||
2697|092|S|notice other effects not listed above, contact your doctor or||
2697|093|S|pharmacist.||
2697|094|S|   In the US -||
2697|095|S|   Call your doctor for medical advice about side effects. You||
2697|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2697|097|S|www.fda.gov/medwatch.||
2697|098|S|   In Canada - Call your doctor for medical advice about side||
2697|099|S|effects. You may report side effects to Health Canada at||
2697|100|S|1-866-234-2345.||
2697|101|B|||
2697|102|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
2697|103|P|pharmacist if you are allergic to it, or if you have any other||
2697|104|P|allergies. This product may contain inactive ingredients, which||
2697|105|P|can cause allergic reactions or other problems. Talk to your||
2697|106|P|pharmacist for more details.||
2697|107|P|   Before using this medication, tell your doctor or pharmacist||
2697|108|P|your medical history, especially of: personal or family history||
2697|109|P|of psychiatric disorders (such as bipolar/manic-depressive||
2697|110|P|disorder), personal or family history of suicide attempts, kidney||
2697|111|P|disease, liver disease.||
2697|112|P|   Gepirone may cause a condition that affects the heart rhythm||
2697|113|P|(QT prolongation). QT prolongation can rarely cause serious||
2697|114|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
2697|115|P|as severe dizziness, fainting) that need medical attention right||
2697|116|P|away.||
2697|117|P|   The risk of QT prolongation may be increased if you have||
2697|118|P|certain medical conditions or are taking other drugs that may||
2697|119|P|cause QT prolongation. Before using gepirone, tell your doctor or||
2697|120|P|pharmacist of all the drugs you take and if you have any of the||
2697|121|P|following conditions: certain heart problems (heart failure, slow||
2697|122|P|heartbeat, QT prolongation in the EKG), family history of certain||
2697|123|P|heart problems (QT prolongation in the EKG, sudden cardiac||
2697|124|P|death).||
2697|125|P|   Low levels of potassium or magnesium in the blood may also||
2697|126|P|increase your risk of QT prolongation. This risk may increase if||
2697|127|P|you use certain drugs (such as diuretics/"water pills") or if you||
2697|128|P|have conditions such as severe sweating, diarrhea, or vomiting.||
2697|129|P|Talk to your doctor about using gepirone safely.||
2697|130|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2697|131|P|can make you more dizzy. Do not drive, use machinery, or do||
2697|132|P|anything that needs alertness until you can do it safely. Limit||
2697|133|P|alcoholic beverages. Talk to your doctor if you are using||
2697|134|P|marijuana (cannabis).||
2697|135|P|   Older adults may be more sensitive to the side effects of this||
2697|136|P|drug, especially QT prolongation (see above).||
2697|137|P|   During pregnancy, this medication should be used only when||
2697|138|P|clearly needed. It may harm an unborn baby. Also, babies born to||
2697|139|P|mothers who have used this drug during the last 3 months of||
2697|140|P|pregnancy may rarely develop withdrawal symptoms such as||
2697|141|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
2697|142|P|constant crying. If you notice any of these symptoms in your||
2697|143|P|newborn, tell the doctor promptly.||
2697|144|P|   Since untreated mental/mood disorders (such as depression) can||
2697|145|P|be a serious condition, do not stop taking this medication unless||
2697|146|P|directed by your doctor. If you are planning pregnancy, become||
2697|147|P|pregnant, or think you may be pregnant, discuss with your doctor||
2697|148|P|right away the benefits and risks of using this medication during||
2697|149|P|pregnancy.||
2697|150|P|   It is unknown if this drug passes into breast milk. Consult||
2697|151|P|your doctor before breastfeeding.||
2697|152|B|||
2697|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2697|154|I|medications work or increase your risk for serious side effects.||
2697|155|I|This document does not contain all possible drug interactions.||
2697|156|I|Keep a list of all the products you use (including||
2697|157|I|prescription/nonprescription drugs and herbal products) and share||
2697|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
2697|159|I|the dosage of any medicines without your doctor's approval.||
2697|160|I|   Taking MAO inhibitors with this medication may cause a serious||
2697|161|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2697|162|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2697|163|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2697|164|I|selegiline, tranylcypromine) during treatment with this||
2697|165|I|medication. Most MAO inhibitors should also not be taken for two||
2697|166|I|weeks before and after treatment with this medication. Ask your||
2697|167|I|doctor when to start or stop taking this medication.||
2697|168|I|   The risk of serotonin syndrome/toxicity increases if you are||
2697|169|I|also taking other drugs that increase serotonin. Examples include||
2697|170|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
2697|171|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
2697|172|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
2697|173|I|serotonin syndrome/toxicity may be more likely when you start or||
2697|174|I|increase the dose of these drugs.||
2697|175|I|   Other medications can affect the removal of gepirone from your||
2697|176|I|body, which may affect how gepirone works. Examples include azole||
2697|177|I|antifungals (such as itraconazole, ketoconazole, posaconazole),||
2697|178|I|cobicistat, macrolide antibiotics (such as clarithromycin),||
2697|179|I|nefazodone, HIV protease inhibitors (such as lopinavir,||
2697|180|I|nelfinavir), ritonavir, rifamycins (such as rifampin), drugs used||
2697|181|I|to treat seizures (such as carbamazepine, phenytoin), among||
2697|182|I|others.||
2697|183|B|||
2697|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2697|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2697|186|O|poison control center right away. US residents can call||
2697|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2697|188|B|||
2697|189|N|NOTES:  Do not share this medication with others.||
2697|190|N|   Lab and/or medical tests (such as blood mineral levels, EKG)||
2697|191|N|should be done before you start taking this medication and while||
2697|192|N|you are taking it. Keep all medical and lab appointments. Consult||
2697|193|N|your doctor for more details.||
2697|194|B|||
2697|195|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2697|196|D|If it is near the time of the next dose, skip the missed dose.||
2697|197|D|Use your next dose at the regular time. Do not double the dose to||
2697|198|D|catch up.||
2697|199|B|||
2697|200|R|STORAGE:  Store at room temperature away from light and moisture.||
2697|201|R|Do not store in the bathroom. Keep all medications away from||
2697|202|R|children and pets.||
2697|203|R|   Do not flush medications down the toilet or pour them into a||
2697|204|R|drain unless instructed to do so. Properly discard this product||
2697|205|R|when it is expired or no longer needed. Consult your pharmacist||
2697|206|R|or local waste disposal company.||
2697|207|B|||
2697|208|A|Information last revised September 2025.||
2697|209|A|Copyright(c) 2025 First Databank, Inc.||
2697|210|B|||
2698|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2698|002|Z|does NOT have all possible information about this product. This||
2698|003|Z|information does not assure that this product is safe, effective,||
2698|004|Z|or appropriate for you. This information is not individual||
2698|005|Z|medical advice and does not substitute for the advice of your||
2698|006|Z|health care professional. Always ask your health care||
2698|007|Z|professional for complete information about this product and your||
2698|008|Z|specific health needs.||
2698|009|B|||
2698|010|T|BUMETANIDE - NASAL||
2698|011|F|(bue-MET-a-nide)||
2698|012|B|||
2698|013|C|COMMON BRAND NAME(S): Enbumyst||
2698|014|B|||
2698|015|W|WARNING:  Bumetanide is a very strong medication. Using too much||
2698|016|W|of this drug can lead to dehydration and electrolyte imbalance.||
2698|017|W|It is important that you are closely monitored by your doctor||
2698|018|W|while using this medication. Tell your doctor right away if you||
2698|019|W|have any symptoms of dehydration or electrolyte imbalance,||
2698|020|W|including unusual dry mouth/thirst, muscle cramps/weakness,||
2698|021|W|slow/fast/irregular heartbeat, or confusion.||
2698|022|B|||
2698|023|U|USES:  Bumetanide is used to reduce extra fluid in the body||
2698|024|U|(edema) caused by conditions such as heart failure, liver||
2698|025|U|disease, and kidney disease. Getting rid of extra water helps to||
2698|026|U|reduce fluid in the lungs so that you can breathe easier. It also||
2698|027|U|helps to decrease swelling of the arms, legs, and||
2698|028|U|stomach/abdomen. This medication is known as a diuretic (the same||
2698|029|U|kind of drug as a "water pill"). It causes your body to get rid||
2698|030|U|of extra water by increasing the amount of urine you make.||
2698|031|U|   The nasal form of bumetanide is not meant for long-term use||
2698|032|U|and is used when the drug cannot be taken by mouth.||
2698|033|B|||
2698|034|V|OTHER USES:  This section contains uses of this drug that are not||
2698|035|V|listed in the approved professional labeling for the drug but||
2698|036|V|that may be prescribed by your health care professional. Use this||
2698|037|V|drug for a condition that is listed in this section only if it||
2698|038|V|has been so prescribed by your health care professional.||
2698|039|V|   This medication may also be used for high blood pressure.||
2698|040|B|||
2698|041|H|HOW TO USE:  Read the Patient Information Leaflet and||
2698|042|H|Instructions for Use if available from your pharmacist before you||
2698|043|H|start using this medication and each time you get a refill. If||
2698|044|H|you have any questions, ask your doctor or pharmacist.||
2698|045|H|   This medication is for use in the nose only. Remove the nasal||
2698|046|H|spray from the package only when you are ready to use it. Do not||
2698|047|H|test or prime the spray before use. Doing so will make you lose||
2698|048|H|the dose.||
2698|049|H|   Before using, blow your nose to clear your nostrils. Spray||
2698|050|H|this medication in the nose as directed by your doctor, usually||
2698|051|H|once a day. If you use this drug too close to bedtime, you may||
2698|052|H|need to wake up to urinate. It is best to use this medication at||
2698|053|H|least 4 hours before your bedtime.||
2698|054|H|   To use the spray, remove the medication from the package. Tilt||
2698|055|H|your head back slightly and carefully insert the tip of the spray||
2698|056|H|nozzle into a nostril. Make sure to point the tip away from the||
2698|057|H|center of your nose. Close the other nostril with the other index||
2698|058|H|finger and then press on the plunger to spray the medication into||
2698|059|H|your nostril. Breathe in gently through the open nostril and||
2698|060|H|breathe out slowly through your mouth. Keep your head back||
2698|061|H|slightly for about 1 minute after using the spray and try not to||
2698|062|H|blow your nose. Each nasal spray only has 1 spray. If your dose||
2698|063|H|is for more than 1 spray, use another nasal spray in the opposite||
2698|064|H|nostril. Throw away the nasal spray after using it.||
2698|065|H|   The dosage is based on your medical condition and response to||
2698|066|H|treatment.||
2698|067|H|   Use this medication regularly to get the most benefit from it.||
2698|068|H|To help you remember, use it at the same time each day. Do not||
2698|069|H|increase your dose or use this drug more often or for longer than||
2698|070|H|prescribed. Your condition will not improve any faster, and your||
2698|071|H|risk of side effects will increase.||
2698|072|H|   Tell your doctor if your condition does not get better or if||
2698|073|H|it gets worse.||
2698|074|B|||
2698|075|S|SIDE EFFECTS:  See also Warning section.||
2698|076|S|   Dizziness or lightheadedness may occur as your body adjusts to||
2698|077|S|the medication. If either of these effects lasts or gets worse,||
2698|078|S|tell your doctor or pharmacist promptly.||
2698|079|S|   To reduce the risk of dizziness and lightheadedness, get up||
2698|080|S|slowly when rising from a sitting or lying position.||
2698|081|S|   Remember that this medication has been prescribed because your||
2698|082|S|doctor has judged that the benefit to you is greater than the||
2698|083|S|risk of side effects. Many people using this medication do not||
2698|084|S|have serious side effects.||
2698|085|S|   Tell your doctor right away if you have any serious side||
2698|086|S|effects, including: numbness/tingling/pain/redness/swelling of||
2698|087|S|the arms/legs, fainting, hearing changes (such as ringing in the||
2698|088|S|ears, decreased hearing), easy bruising/bleeding, signs of kidney||
2698|089|S|problems (such as change in the amount of urine).||
2698|090|S|   A very serious allergic reaction to this drug is rare.||
2698|091|S|However, get medical help right away if you notice any symptoms||
2698|092|S|of a serious allergic reaction, including: rash, itching/swelling||
2698|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2698|094|S|breathing.||
2698|095|S|   This is not a complete list of possible side effects. If you||
2698|096|S|notice other effects not listed above, contact your doctor or||
2698|097|S|pharmacist.||
2698|098|S|   In the US -||
2698|099|S|   Call your doctor for medical advice about side effects. You||
2698|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2698|101|S|www.fda.gov/medwatch.||
2698|102|S|   In Canada - Call your doctor for medical advice about side||
2698|103|S|effects. You may report side effects to Health Canada at||
2698|104|S|1-866-234-2345.||
2698|105|B|||
2698|106|P|PRECAUTIONS:  Before using bumetanide, tell your doctor or||
2698|107|P|pharmacist if you are allergic to it; or if you have any other||
2698|108|P|allergies. This product may contain inactive ingredients, which||
2698|109|P|can cause allergic reactions or other problems. Talk to your||
2698|110|P|pharmacist for more details.||
2698|111|P|   Before using this medication, tell your doctor or pharmacist||
2698|112|P|your medical history, especially of: kidney problems (such as||
2698|113|P|inability to make urine), liver problems, gout, nasal problems||
2698|114|P|(such as runny/stuffy nose, broken nose).||
2698|115|P|   If you have diabetes, bumetanide may affect your blood sugar.||
2698|116|P|Check your blood sugar regularly as directed and share the||
2698|117|P|results with your doctor. Your doctor may need to adjust your||
2698|118|P|diabetes medication or diet.||
2698|119|P|   This drug may reduce the potassium levels in your blood. Ask||
2698|120|P|your doctor about adding potassium to your diet. A potassium||
2698|121|P|supplement may be prescribed by your doctor.||
2698|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2698|123|P|can make you more dizzy. Do not drive, use machinery, or do||
2698|124|P|anything that needs alertness until you can do it safely. Limit||
2698|125|P|alcoholic beverages. Talk to your doctor if you are using||
2698|126|P|marijuana (cannabis).||
2698|127|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
2698|128|P|and cause you to feel lightheaded. Tell your doctor if you have||
2698|129|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
2698|130|P|of fluids unless your doctor tells you not to.||
2698|131|P|   Before having surgery, tell your doctor or dentist about all||
2698|132|P|the products you use (including prescription drugs,||
2698|133|P|nonprescription drugs, and herbal products).||
2698|134|P|   Older adults may be more sensitive to the effects of this||
2698|135|P|drug, especially dizziness and water/mineral loss.||
2698|136|P|   During pregnancy, this drug should be used only when clearly||
2698|137|P|needed. Discuss the risks and benefits with your doctor.||
2698|138|P|   It is unknown if this drug passes into breast milk. Consult||
2698|139|P|your doctor before breastfeeding.||
2698|140|B|||
2698|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2698|142|I|medications work or increase your risk for serious side effects.||
2698|143|I|This document does not contain all possible drug interactions.||
2698|144|I|Keep a list of all the products you use (including||
2698|145|I|prescription/nonprescription drugs and herbal products) and share||
2698|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
2698|147|I|the dosage of any medicines without your doctor's approval.||
2698|148|I|   Some products that may interact with this drug are:||
2698|149|I|desmopressin, lithium, probenecid.||
2698|150|I|   Some products have ingredients that could raise your blood||
2698|151|I|pressure or worsen your swelling. Tell your pharmacist what||
2698|152|I|products you are using, and ask how to use them safely||
2698|153|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
2698|154|I|ibuprofen/naproxen).||
2698|155|B|||
2698|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2698|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2698|158|O|poison control center right away. US residents can call||
2698|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2698|160|O|Symptoms of overdose may include: fainting, severe weakness, a||
2698|161|O|severe decrease in the amount of urine.||
2698|162|B|||
2698|163|N|NOTES:  Do not share this medication with others.||
2698|164|N|   Lifestyle changes that may help this medication work better||
2698|165|N|include exercising, stopping smoking, and eating a||
2698|166|N|low-cholesterol/low-fat diet. Consult your doctor for more||
2698|167|N|details.||
2698|168|N|   Lab and/or medical tests (such as kidney function, blood||
2698|169|N|mineral levels such as potassium) should be done while you are||
2698|170|N|using this medication. Keep all medical and lab appointments.||
2698|171|N|Consult your doctor for more details.||
2698|172|N|   Check your blood pressure and pulse (heart rate) regularly||
2698|173|N|while using this medication. Learn how to check your own blood||
2698|174|N|pressure and pulse at home, and share the results with your||
2698|175|N|doctor.||
2698|176|B|||
2698|177|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2698|178|D|If it is near the time of the next dose, skip the missed dose.||
2698|179|D|Use your next dose at the regular time. Do not double the dose to||
2698|180|D|catch up.||
2698|181|B|||
2698|182|R|STORAGE:  Store at room temperature. Do not freeze. Keep the||
2698|183|R|medication in the original packaging until ready to use. Keep all||
2698|184|R|medications away from children and pets.||
2698|185|R|   Do not flush medications down the toilet or pour them into a||
2698|186|R|drain unless instructed to do so. Properly discard this product||
2698|187|R|when it is expired or no longer needed. Consult your pharmacist||
2698|188|R|or local waste disposal company.||
2698|189|B|||
2698|190|A|Information last revised October 2025.||
2698|191|A|Copyright(c) 2025 First Databank, Inc.||
2698|192|B|||
2699|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2699|002|Z|does NOT have all possible information about this product. This||
2699|003|Z|information does not assure that this product is safe, effective,||
2699|004|Z|or appropriate for you. This information is not individual||
2699|005|Z|medical advice and does not substitute for the advice of your||
2699|006|Z|health care professional. Always ask your health care||
2699|007|Z|professional for complete information about this product and your||
2699|008|Z|specific health needs.||
2699|009|B|||
2699|010|T|AVATROMBOPAG SPRINKLE CAPSULE - ORAL||
2699|011|F|(A-va-TROM-boe-pag)||
2699|012|B|||
2699|013|C|COMMON BRAND NAME(S): Doptelet Sprinkle||
2699|014|B|||
2699|015|U|USES:  This form of avatrombopag is given to children to treat a||
2699|016|U|certain blood disorder known as immune thrombocytopenia-ITP. This||
2699|017|U|is a condition where the amount of platelets in the blood is||
2699|018|U|lower than normal. ITP can lead to serious bleeding problems.||
2699|019|U|This medication increases the production of platelets by your||
2699|020|U|child's body to help prevent too much bleeding from ITP.||
2699|021|B|||
2699|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
2699|023|H|Instructions for Use leaflet if available from the pharmacist||
2699|024|H|before your child starts taking avatrombopag and each time you||
2699|025|H|get a refill. If you have any questions, ask the doctor or||
2699|026|H|pharmacist.||
2699|027|H|   This medication is taken by mouth with food as directed by the||
2699|028|H|doctor, usually once daily. The dosage is based on your child's||
2699|029|H|medical condition, lab tests, response to treatment, and other||
2699|030|H|medications your child may be taking. Be sure to tell the doctor||
2699|031|H|and pharmacist about all the products your child uses (including||
2699|032|H|prescription drugs, nonprescription drugs, and herbal products).||
2699|033|H|   Do not swallow the capsules whole. Open the capsule(s) and||
2699|034|H|sprinkle the granules onto a small amount of soft food (such as||
2699|035|H|applesauce, strawberry jelly, or plain yogurt) or liquid (such as||
2699|036|H|whole/skim milk, orange juice, water, or unflavored pediatric||
2699|037|H|electrolyte solution) in a spoon or cup. Mix the granules and||
2699|038|H|swallow the mixture right away. The granules will not dissolve.||
2699|039|H|Do not prepare the mixture ahead of time for later use. Rinse the||
2699|040|H|spoon or cup with soft food or liquid and swallow again to make||
2699|041|H|sure all of the drug is swallowed. Do not crush or chew the||
2699|042|H|granules.||
2699|043|H|   Use this medication regularly to get the most benefit from it.||
2699|044|H|To help you remember, give it at the same time each day.||
2699|045|B|||
2699|046|S|SIDE EFFECTS:  Runny nose, cough, or fever may occur. If any of||
2699|047|S|these effects last or get worse, tell the doctor or pharmacist||
2699|048|S|promptly.||
2699|049|S|   Remember that this medication has been prescribed because the||
2699|050|S|doctor has judged that the benefit to your child is greater than||
2699|051|S|the risk of side effects. Many people using this medication do||
2699|052|S|not have serious side effects.||
2699|053|S|   This medication may rarely cause serious problems from blood||
2699|054|S|clots (such as heart attack, stroke, blood clots in the lungs or||
2699|055|S|legs). Your child may be at increased risk for blood clots if||
2699|056|S|they have a history of blood clots, chronic liver disease,||
2699|057|S|certain inherited blood clotting disorders, or if they are||
2699|058|S|immobile (such as on very long plane flights or being bedridden).||
2699|059|S|If your child uses estrogen-containing products, these may also||
2699|060|S|increase their risk. Before using this medication, if your child||
2699|061|S|has any of these conditions report them to the doctor or||
2699|062|S|pharmacist (see also Precautions section). Get medical help right||
2699|063|S|away if any of these side effects occur: shortness of||
2699|064|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
2699|065|S|sweating, confusion, sudden dizziness/fainting,||
2699|066|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
2699|067|S|trouble speaking, weakness on one side of the body, sudden vision||
2699|068|S|changes, stomach/abdominal pain or tenderness.||
2699|069|S|   A very serious allergic reaction to this drug is rare.||
2699|070|S|However, get medical help right away if you notice any symptoms||
2699|071|S|of a serious allergic reaction, including: rash, itching/swelling||
2699|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2699|073|S|breathing.||
2699|074|S|   This is not a complete list of possible side effects. If you||
2699|075|S|notice other effects not listed above, contact the doctor or||
2699|076|S|pharmacist.||
2699|077|S|   In the US -||
2699|078|S|   Call the doctor for medical advice about side effects. You may||
2699|079|S|report side effects to FDA at 1-800-FDA-1088 or at||
2699|080|S|www.fda.gov/medwatch.||
2699|081|S|   In Canada - Call the doctor for medical advice about side||
2699|082|S|effects. You may report side effects to Health Canada at||
2699|083|S|1-866-234-2345.||
2699|084|B|||
2699|085|P|PRECAUTIONS:  Before giving avatrombopag, tell the doctor or||
2699|086|P|pharmacist if your child is allergic to it; or if your child has||
2699|087|P|any other allergies. This product may contain inactive||
2699|088|P|ingredients, which can cause allergic reactions or other||
2699|089|P|problems. Talk to the pharmacist for more details.||
2699|090|P|   Before giving this medication, tell the doctor or pharmacist||
2699|091|P|your child's medical history, especially of: blood clotting||
2699|092|P|disorders (such as protein C or protein S deficiency,||
2699|093|P|antithrombin deficiency, Factor V Leiden).||
2699|094|P|   Before having surgery, tell the doctor or dentist about all||
2699|095|P|the products your child uses (including prescription drugs,||
2699|096|P|nonprescription drugs, and herbal products).||
2699|097|P|   This form of avatrombopag is not usually used by adults. It is||
2699|098|P|unlikely to be used during pregnancy or breastfeeding. Consult||
2699|099|P|the doctor if you have any questions about this medication.||
2699|100|B|||
2699|101|I|DRUG INTERACTIONS:  Drug interactions may change how your child's||
2699|102|I|medications work or increase your child's risk for serious side||
2699|103|I|effects. This document does not contain all possible drug||
2699|104|I|interactions. Keep a list of all the products your child uses||
2699|105|I|(including prescription/nonprescription drugs and herbal||
2699|106|I|products) and share it with the doctor and pharmacist. Do not||
2699|107|I|start, stop, or change the dosage of any medicines without the||
2699|108|I|doctor's approval.||
2699|109|B|||
2699|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2699|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2699|112|O|poison control center right away. US residents can call||
2699|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2699|114|B|||
2699|115|N|NOTES:  Do not share this medication with others.||
2699|116|N|   Lab and/or medical tests (such as platelet count or blood||
2699|117|N|mineral levels) should be done before your child starts taking||
2699|118|N|this medication and while your child is taking it. Keep all||
2699|119|N|medical and lab appointments.||
2699|120|B|||
2699|121|D|MISSED DOSE:  If your child misses a dose, give it as soon as you||
2699|122|D|remember. If it is near the time of the next dose, skip the||
2699|123|D|missed dose. Give the next dose at the regular time. Do not||
2699|124|D|double the dose to catch up.||
2699|125|B|||
2699|126|R|STORAGE:  Store at room temperature away from light and moisture.||
2699|127|R|Do not store in the bathroom. Keep all medications away from||
2699|128|R|children and pets.||
2699|129|R|   Do not flush medications down the toilet or pour them into a||
2699|130|R|drain unless instructed to do so. Properly discard this product||
2699|131|R|when it is expired or no longer needed. Consult the pharmacist or||
2699|132|R|local waste disposal company.||
2699|133|B|||
2699|134|M|MEDICAL ALERT:  Your child's condition can cause complications in||
2699|135|M|a medical emergency. For information about enrolling in||
2699|136|M|MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
2699|137|B|||
2699|138|A|Information last revised October 2025.||
2699|139|A|Copyright(c) 2025 First Databank, Inc.||
2699|140|B|||
2700|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2700|002|Z|does NOT have all possible information about this product. This||
2700|003|Z|information does not assure that this product is safe, effective,||
2700|004|Z|or appropriate for you. This information is not individual||
2700|005|Z|medical advice and does not substitute for the advice of your||
2700|006|Z|health care professional. Always ask your health care||
2700|007|Z|professional for complete information about this product and your||
2700|008|Z|specific health needs.||
2700|009|B|||
2700|010|T|PALTUSOTINE - ORAL||
2700|011|F|(pal-TOO-soe-teen)||
2700|012|B|||
2700|013|C|COMMON BRAND NAME(S): Palsonify||
2700|014|B|||
2700|015|U|USES:  Paltusotine is used to treat a certain condition||
2700|016|U|(acromegaly) that occurs when the body makes too much of a||
2700|017|U|certain natural substance called growth hormone. Treating||
2700|018|U|acromegaly helps reduce the risk of serious problems such as||
2700|019|U|diabetes and heart disease. Paltusotine works by decreasing how||
2700|020|U|much growth hormone your body makes.||
2700|021|B|||
2700|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2700|023|H|from your pharmacist before you start taking paltusotine and each||
2700|024|H|time you get a refill. If you have any questions, ask your doctor||
2700|025|H|or pharmacist.||
2700|026|H|   Take this medication by mouth with water on an empty stomach||
2700|027|H|at least 6 hours after a meal (for example, after not eating||
2700|028|H|overnight) and at least 1 hour before the next meal as directed||
2700|029|H|by your doctor, usually once a day.||
2700|030|H|   The dosage is based on your medical condition, response to||
2700|031|H|treatment, lab tests, and other medications you may be taking. Be||
2700|032|H|sure to tell your doctor and pharmacist about all the products||
2700|033|H|you use (including prescription drugs, nonprescription drugs, and||
2700|034|H|herbal products).||
2700|035|H|   To reduce your risk of side effects, your doctor may direct||
2700|036|H|you to start this medication at a low dose and gradually increase||
2700|037|H|your dose. Follow your doctor's instructions carefully.||
2700|038|H|   Use this medication regularly to get the most benefit from it.||
2700|039|H|To help you remember, take it at the same time each day.||
2700|040|H|   Do not increase your dose or use this drug more often or for||
2700|041|H|longer than prescribed. Your condition will not improve any||
2700|042|H|faster, and your risk of side effects will increase.||
2700|043|H|   Tell your doctor if your condition does not get better or if||
2700|044|H|it gets worse.||
2700|045|B|||
2700|046|S|SIDE EFFECTS:  Nausea, diarrhea, stomach upset, loss of appetite,||
2700|047|S|gas, or bloating may occur. If any of these effects last or get||
2700|048|S|worse, tell your doctor or pharmacist promptly.||
2700|049|S|   Remember that this medication has been prescribed because your||
2700|050|S|doctor has judged that the benefit to you is greater than the||
2700|051|S|risk of side effects. Many people using this medication do not||
2700|052|S|have serious side effects.||
2700|053|S|   Tell your doctor right away if you have any serious side||
2700|054|S|effects, including: signs of gallbladder problems (such as fever,||
2700|055|S|stomach/abdominal pain, severe nausea/vomiting, yellowing||
2700|056|S|eyes/skin, unexplained pain in the back/right shoulder), signs of||
2700|057|S|underactive thyroid (such as unexplained weight gain, cold||
2700|058|S|intolerance, severe constipation, unusual/extreme tiredness,||
2700|059|S|growth/lump/swelling on the front of the neck),||
2700|060|S|slow/fast/irregular heartbeat, weight loss, change in stool||
2700|061|S|color.||
2700|062|S|   This medication may cause changes in blood sugar, especially||
2700|063|S|if you have diabetes. Symptoms of high blood sugar include||
2700|064|S|increased thirst and urination. Symptoms of low blood sugar||
2700|065|S|include sudden sweating, shaking, fast heartbeat, hunger, blurred||
2700|066|S|vision, dizziness, or tingling hands/feet. Tell your doctor right||
2700|067|S|away if you experience symptoms of high or low blood sugar while||
2700|068|S|using this medication. If you already have diabetes, check your||
2700|069|S|blood sugar regularly as directed and share the results with your||
2700|070|S|doctor. Your doctor may need to adjust your diabetes medication,||
2700|071|S|exercise program, or diet.||
2700|072|S|   A very serious allergic reaction to this drug is rare.||
2700|073|S|However, get medical help right away if you notice any symptoms||
2700|074|S|of a serious allergic reaction, including: rash, itching/swelling||
2700|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2700|076|S|breathing.||
2700|077|S|   This is not a complete list of possible side effects. If you||
2700|078|S|notice other effects not listed above, contact your doctor or||
2700|079|S|pharmacist.||
2700|080|S|   In the US -||
2700|081|S|   Call your doctor for medical advice about side effects. You||
2700|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2700|083|S|www.fda.gov/medwatch.||
2700|084|S|   In Canada - Call your doctor for medical advice about side||
2700|085|S|effects. You may report side effects to Health Canada at||
2700|086|S|1-866-234-2345.||
2700|087|B|||
2700|088|P|PRECAUTIONS:  Before using paltusotine, tell your doctor or||
2700|089|P|pharmacist if you are allergic to it; or if you have any other||
2700|090|P|allergies. This product may contain inactive ingredients, which||
2700|091|P|can cause allergic reactions or other problems. Talk to your||
2700|092|P|pharmacist for more details.||
2700|093|P|   Before using this medication, tell your doctor or pharmacist||
2700|094|P|your medical history, especially of: diabetes, thyroid problems,||
2700|095|P|gallbladder problems (such as gallstones), heart problems (such||
2700|096|P|as slow heartbeat), nutrition problems (such as decreased fat||
2700|097|P|absorption, vitamin B12 deficiency).||
2700|098|P|   Before having surgery, tell your doctor or dentist about all||
2700|099|P|the products you use (including prescription drugs,||
2700|100|P|nonprescription drugs, and herbal products).||
2700|101|P|   Treatment with this medication may improve fertility in women||
2700|102|P|and may lead to unintended pregnancy. Ask your doctor for more||
2700|103|P|details.||
2700|104|P|   During pregnancy, this medication should be used only when||
2700|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
2700|106|P|   It is unknown if this drug passes into breast milk. Consult||
2700|107|P|your doctor before breastfeeding.||
2700|108|B|||
2700|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2700|110|I|medications work or increase your risk for serious side effects.||
2700|111|I|This document does not contain all possible drug interactions.||
2700|112|I|Keep a list of all the products you use (including||
2700|113|I|prescription/nonprescription drugs and herbal products) and share||
2700|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
2700|115|I|the dosage of any medicines without your doctor's approval.||
2700|116|B|||
2700|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2700|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2700|119|O|poison control center right away. US residents can call||
2700|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2700|121|B|||
2700|122|N|NOTES:  Do not share this medication with others.||
2700|123|N|   Lab and/or medical tests (such as blood sugar, thyroid||
2700|124|N|function, hormone levels, vitamin B12 levels) should be done||
2700|125|N|before you start taking this medication and while you are taking||
2700|126|N|it. Keep all medical and lab appointments.||
2700|127|B|||
2700|128|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2700|129|D|remember. If it is near the time of the next dose, skip the||
2700|130|D|missed dose. Take your next dose at the regular time. Do not||
2700|131|D|double the dose to catch up.||
2700|132|B|||
2700|133|R|STORAGE:  Store in the original bottle at room temperature away||
2700|134|R|from light and moisture. Do not store in the bathroom. Keep all||
2700|135|R|medications away from children and pets.||
2700|136|R|   Do not flush medications down the toilet or pour them into a||
2700|137|R|drain unless instructed to do so. Properly discard this product||
2700|138|R|when it is expired or no longer needed. Consult your pharmacist||
2700|139|R|or local waste disposal company.||
2700|140|B|||
2700|141|A|Information last revised October 2025.||
2700|142|A|Copyright(c) 2025 First Databank, Inc.||
2700|143|B|||
2701|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2701|002|Z|does NOT have all possible information about this product. This||
2701|003|Z|information does not assure that this product is safe, effective,||
2701|004|Z|or appropriate for you. This information is not individual||
2701|005|Z|medical advice and does not substitute for the advice of your||
2701|006|Z|health care professional. Always ask your health care||
2701|007|Z|professional for complete information about this product and your||
2701|008|Z|specific health needs.||
2701|009|B|||
2701|010|T|PEMBROLIZUMAB/BERAHYALURONIDASE ALFA - SUBCUTANEOUS INJECTION||
2701|011|B|||
2701|012|C|COMMON BRAND NAME(S): Keytruda Qlex||
2701|013|B|||
2701|014|U|USES:  This medication is used to treat cancer. It contains 2||
2701|015|U|ingredients: pembrolizumab and berahyaluronidase alfa.||
2701|016|U|Pembrolizumab belongs to a class of drugs known as monoclonal||
2701|017|U|antibodies. It works by changing how your immune system works,||
2701|018|U|making it attack cancer cells. Berahyaluronidase alfa is used to||
2701|019|U|help the body absorb pembrolizumab, which helps it work better.||
2701|020|B|||
2701|021|H|HOW TO USE:  Read the Medication Guide provided by your||
2701|022|H|pharmacist before you start using pembrolizumab/berahyaluronidase||
2701|023|H|alfa and each time you get a treatment. If you have any||
2701|024|H|questions, ask your doctor or pharmacist.||
2701|025|H|   This medication is given by injection under the skin by a||
2701|026|H|health care professional. It is injected slowly into the abdomen||
2701|027|H|or thigh over 1 or 2 minutes. It is given as directed by your||
2701|028|H|doctor, usually once every 3 weeks or once every 6 weeks. The||
2701|029|H|dosage is based on your medical condition and response to||
2701|030|H|treatment.||
2701|031|H|   Injection reactions may happen during the injection of this||
2701|032|H|drug. Tell your doctor right away if you have any symptoms of||
2701|033|H|injection reactions such as fever, chills, shivering, itching,||
2701|034|H|rash, flushing, dizziness, wheezing, or shortness of breath. Your||
2701|035|H|doctor may stop your treatment for some time.||
2701|036|H|   Use this medication regularly to get the most benefit from it.||
2701|037|H|To help you remember, mark your calendar with a reminder.||
2701|038|B|||
2701|039|S|SIDE EFFECTS:  See also How to Use section.||
2701|040|S|   Tiredness, swelling ankles/feet/hands, itchy skin, nausea,||
2701|041|S|vomiting, abdominal pain, or trouble sleeping may occur. If any||
2701|042|S|of these effects last or get worse, tell your doctor or||
2701|043|S|pharmacist promptly.||
2701|044|S|   People using this medication may have serious side effects.||
2701|045|S|Some of these effects may occur even after stopping treatment.||
2701|046|S|However, you have been prescribed this drug because your doctor||
2701|047|S|has judged that the benefit to you is greater than the risk of||
2701|048|S|side effects. Careful monitoring by your doctor may decrease your||
2701|049|S|risk.||
2701|050|S|   Tell your doctor right away if you have any serious side||
2701|051|S|effects, including: headache that is unusual or doesn't go away,||
2701|052|S|new/worsening cough, shortness of breath, diarrhea with||
2701|053|S|blood/mucus, symptoms of liver disease (such as nausea/vomiting||
2701|054|S|that doesn't stop, loss of appetite, stomach/abdominal pain,||
2701|055|S|yellowing eyes/skin, dark urine), signs of kidney problems (such||
2701|056|S|as change in the amount of urine, pink/bloody urine),||
2701|057|S|dizziness/fainting, deepening of the voice, vision changes, eye||
2701|058|S|redness/pain/sensitivity to light, numbness/tingling of the||
2701|059|S|arms/legs, joint stiffness/pain, muscle weakness/tenderness/pain,||
2701|060|S|signs of infection (such as sore throat that doesn't go away,||
2701|061|S|fever, chills, burning/painful/frequent/urgent urination), easy||
2701|062|S|bruising/bleeding.||
2701|063|S|   This medication may cause hormone gland problems (such as||
2701|064|S|thyroid, pituitary, adrenal, pancreas). Your body could make too||
2701|065|S|much or too little hormone. Tell your doctor right away if you||
2701|066|S|have any symptoms such as: cold or heat intolerance, unexplained||
2701|067|S|weight loss/gain, mental/mood changes,||
2701|068|S|slow/fast/pounding/irregular heartbeat, unusual tiredness,||
2701|069|S|constipation.||
2701|070|S|   This medication may rarely make your blood sugar rise, which||
2701|071|S|can cause or worsen diabetes. Tell your doctor right away if you||
2701|072|S|have symptoms of high blood sugar such as increased||
2701|073|S|thirst/urination. If you already have diabetes, check your blood||
2701|074|S|sugar regularly as directed and share the results with your||
2701|075|S|doctor. Your doctor may need to adjust your diabetes medication,||
2701|076|S|exercise program, or diet.||
2701|077|S|   Get medical help right away if you have any very serious side||
2701|078|S|effects, including: chest pain, seizure.||
2701|079|S|   A very serious allergic reaction to this drug is rare.||
2701|080|S|However, get medical help right away if you notice any symptoms||
2701|081|S|of a serious allergic reaction, including: rash, itching/swelling||
2701|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2701|083|S|breathing.||
2701|084|S|   This is not a complete list of possible side effects. If you||
2701|085|S|notice other effects not listed above, contact your doctor or||
2701|086|S|pharmacist.||
2701|087|S|   In the US -||
2701|088|S|   Call your doctor for medical advice about side effects. You||
2701|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2701|090|S|www.fda.gov/medwatch.||
2701|091|S|   In Canada - Call your doctor for medical advice about side||
2701|092|S|effects. You may report side effects to Health Canada at||
2701|093|S|1-866-234-2345.||
2701|094|B|||
2701|095|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2701|096|P|pharmacist if you are allergic to it; or if you have any other||
2701|097|P|allergies. This product may contain inactive ingredients, which||
2701|098|P|can cause allergic reactions or other problems. Talk to your||
2701|099|P|pharmacist for more details.||
2701|100|P|   Before using this medication, tell your doctor or pharmacist||
2701|101|P|your medical history, especially of: organ/tissue transplant.||
2701|102|P|   People who receive a donor stem cell transplant after||
2701|103|P|treatment with this medication may have very serious (possibly||
2701|104|P|fatal) complications. Ask your doctor for more details.||
2701|105|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
2701|106|P|can make you more dizzy. Do not drive, use machinery, or do||
2701|107|P|anything that needs alertness until you can do it safely. Limit||
2701|108|P|alcoholic beverages. Talk to your doctor if you are using||
2701|109|P|marijuana (cannabis).||
2701|110|P|   Before having surgery, tell your doctor or dentist about all||
2701|111|P|the products you use (including prescription drugs,||
2701|112|P|nonprescription drugs, and herbal products).||
2701|113|P|   Tell your doctor if you are pregnant or plan to become||
2701|114|P|pregnant. You should not become pregnant while using this||
2701|115|P|medication. This medication may harm an unborn baby. Your doctor||
2701|116|P|should order a pregnancy test before you start this medication.||
2701|117|P|Ask about reliable forms of birth control while using this||
2701|118|P|medication and for 4 months after the last dose. If you become||
2701|119|P|pregnant, talk to your doctor right away about the risks and||
2701|120|P|benefits of this medication.||
2701|121|P|   It is unknown if this drug passes into breast milk. Because of||
2701|122|P|the possible risk to the infant, breastfeeding is not recommended||
2701|123|P|while using this drug and for 4 months after the last dose.||
2701|124|P|Consult your doctor before breastfeeding.||
2701|125|B|||
2701|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2701|127|I|medications work or increase your risk for serious side effects.||
2701|128|I|This document does not contain all possible drug interactions.||
2701|129|I|Keep a list of all the products you use (including||
2701|130|I|prescription/nonprescription drugs and herbal products) and share||
2701|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
2701|132|I|the dosage of any medicines without your doctor's approval.||
2701|133|B|||
2701|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2701|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2701|136|O|poison control center right away. US residents can call||
2701|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2701|138|B|||
2701|139|N|NOTES:  Lab and/or medical tests (such as liver/kidney/thyroid||
2701|140|N|function, blood sugar, complete blood count) should be done||
2701|141|N|before you start using this medication and while you are using||
2701|142|N|it. Keep all medical and lab appointments. Consult your doctor||
2701|143|N|for more details.||
2701|144|B|||
2701|145|D|MISSED DOSE:  It is important to get each dose of this medication||
2701|146|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
2701|147|D|right away for a new dosing schedule.||
2701|148|B|||
2701|149|R|STORAGE:  Not applicable. This medication is given in a hospital||
2701|150|R|or clinic and will not be stored at home.||
2701|151|B|||
2701|152|A|Information last revised October 2025.||
2701|153|A|Copyright(c) 2025 First Databank, Inc.||
2701|154|B|||
2702|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2702|002|Z|does NOT have all possible information about this product. This||
2702|003|Z|information does not assure that this product is safe, effective,||
2702|004|Z|or appropriate for you. This information is not individual||
2702|005|Z|medical advice and does not substitute for the advice of your||
2702|006|Z|health care professional. Always ask your health care||
2702|007|Z|professional for complete information about this product and your||
2702|008|Z|specific health needs.||
2702|009|B|||
2702|010|T|NIFEDIPINE/LIDOCAINE - RECTAL||
2702|011|F|(nye-FED-i-peen/ LYE-doe-kane)||
2702|012|B|||
2702|013|U|USES:  This product is used to treat a certain problem in the||
2702|014|U|anal area (anal fissure). It can help decrease pain in the area||
2702|015|U|and help the anal fissure to heal. This product contains 2 drugs:||
2702|016|U|nifedipine and lidocaine. Nifedipine belongs to a class of drugs||
2702|017|U|known as calcium channel blockers. It works by relaxing the||
2702|018|U|muscles around the anus. Lidocaine belongs to a class of drugs||
2702|019|U|known as local anesthetics. It works by temporarily numbing the||
2702|020|U|area.||
2702|021|B|||
2702|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2702|023|H|from your pharmacist before you start using this product and each||
2702|024|H|time you get a refill. If you have any questions, ask your doctor||
2702|025|H|or pharmacist.||
2702|026|H|   Follow all instructions in the product package for using the||
2702|027|H|applicator tip/cap/nozzle. Before use, clean the affected area||
2702|028|H|with mild soap and water, rinse well, and pat dry. Gently insert||
2702|029|H|the applicator tip up to 0.5 inch (1 centimeter) inside the anus||
2702|030|H|and apply the product in and around the anal opening as directed||
2702|031|H|by your doctor, usually twice daily.||
2702|032|H|   Wash hands immediately after use. Avoid getting the product in||
2702|033|H|your eyes, nose, ears, or mouth. If the medication gets in one of||
2702|034|H|these areas, rinse the area immediately with clean water.||
2702|035|H|   Use this medication regularly to get the most benefit from it.||
2702|036|H|To help you remember, use it at the same times each day.||
2702|037|H|   Do not increase your dose or use this drug more often or for||
2702|038|H|longer than prescribed. Your condition will not improve any||
2702|039|H|faster, and your risk of side effects will increase.||
2702|040|H|   Tell your doctor if your condition does not get better or if||
2702|041|H|it gets worse.||
2702|042|B|||
2702|043|S|SIDE EFFECTS:  Redness, burning, or itching at the application||
2702|044|S|site, headache, nausea, or vomiting may occur. If any of these||
2702|045|S|effects last or get worse, tell your doctor or pharmacist||
2702|046|S|promptly.||
2702|047|S|   Remember that this medication has been prescribed because your||
2702|048|S|doctor has judged that the benefit to you is greater than the||
2702|049|S|risk of side effects. Many people using this medication do not||
2702|050|S|have serious side effects.||
2702|051|S|   Tell your doctor right away if you have any serious side||
2702|052|S|effects, including: dizziness, rectal bleeding.||
2702|053|S|   Get medical help right away if you have any very serious side||
2702|054|S|effects, including: slow/shallow breathing, unusual tiredness,||
2702|055|S|fainting, seizures, pale/bluish/gray skin, shortness of breath,||
2702|056|S|fast/slow/irregular heartbeat.||
2702|057|S|   A very serious allergic reaction to this drug is rare.||
2702|058|S|However, get medical help right away if you notice any symptoms||
2702|059|S|of a serious allergic reaction, including: rash, itching/swelling||
2702|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2702|061|S|breathing.||
2702|062|S|   This is not a complete list of possible side effects. If you||
2702|063|S|notice other effects not listed above, contact your doctor or||
2702|064|S|pharmacist.||
2702|065|S|   In the US -||
2702|066|S|   Call your doctor for medical advice about side effects. You||
2702|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2702|068|S|www.fda.gov/medwatch.||
2702|069|S|   In Canada - Call your doctor for medical advice about side||
2702|070|S|effects. You may report side effects to Health Canada at||
2702|071|S|1-866-234-2345.||
2702|072|B|||
2702|073|P|PRECAUTIONS:  Before using this product, tell your doctor or||
2702|074|P|pharmacist if you are allergic to nifedipine or lidocaine; or to||
2702|075|P|other calcium channel blockers (such as amlodipine, felodipine);||
2702|076|P|or to other amide anesthetics (such as bupivacaine, prilocaine);||
2702|077|P|or if you have any other allergies. This product may contain||
2702|078|P|inactive ingredients, which can cause allergic reactions or other||
2702|079|P|problems. Talk to your pharmacist for more details.||
2702|080|P|   Before using this medication, tell your doctor or pharmacist||
2702|081|P|your medical history, especially of: low blood pressure, heart||
2702|082|P|disease (such as heart failure, aortic stenosis, chest pain,||
2702|083|P|recent heart attack), a certain blood disorder||
2702|084|P|(methemoglobinemia), injury/infection in the rectal area, liver||
2702|085|P|disease, kidney disease.||
2702|086|P|   Before having surgery, tell your doctor or dentist about all||
2702|087|P|the products you use (including prescription drugs,||
2702|088|P|nonprescription drugs, and herbal products).||
2702|089|P|   Older adults may be more sensitive to the side effects of this||
2702|090|P|medication.||
2702|091|P|   During pregnancy, this medication should be used only when||
2702|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
2702|093|P|   Nifedipine and lidocaine pass into breast milk. Consult your||
2702|094|P|doctor before breastfeeding.||
2702|095|B|||
2702|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2702|097|I|medications work or increase your risk for serious side effects.||
2702|098|I|This document does not contain all possible drug interactions.||
2702|099|I|Keep a list of all the products you use (including||
2702|100|I|prescription/nonprescription drugs and herbal products) and share||
2702|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
2702|102|I|the dosage of any medicines without your doctor's approval.||
2702|103|B|||
2702|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2702|105|O|has overdosed and has serious symptoms such as passing out or||
2702|106|O|trouble breathing, call 911. Otherwise, call a poison control||
2702|107|O|center right away. US residents can call 1-800-222-1222. Canada||
2702|108|O|residents can call 1-844-764-7669.||
2702|109|B|||
2702|110|N|NOTES:  Lab and/or medical tests (such as blood pressure, heart||
2702|111|N|rate) may be done while you are using this medication. Keep all||
2702|112|N|medical and lab appointments. Consult your doctor for more||
2702|113|N|details.||
2702|114|N|   This medication has been prescribed for your current condition||
2702|115|N|only. Do not use it later for another condition unless your||
2702|116|N|doctor tells you to.||
2702|117|B|||
2702|118|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
2702|119|D|next dose at the regular time. Do not double the dose to catch||
2702|120|D|up.||
2702|121|B|||
2702|122|R|STORAGE:  Store at room temperature away from light. Do not||
2702|123|R|freeze. Keep all medications away from children and pets.||
2702|124|R|   Do not flush medications down the toilet or pour them into a||
2702|125|R|drain unless instructed to do so. Properly discard this product||
2702|126|R|when it is expired or no longer needed. Consult your pharmacist||
2702|127|R|or local waste disposal company.||
2702|128|B|||
2702|129|A|Information last revised October 2025.||
2702|130|A|Copyright(c) 2025 First Databank, Inc.||
2702|131|B|||
2703|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2703|002|Z|does NOT have all possible information about this product. This||
2703|003|Z|information does not assure that this product is safe, effective,||
2703|004|Z|or appropriate for you. This information is not individual||
2703|005|Z|medical advice and does not substitute for the advice of your||
2703|006|Z|health care professional. Always ask your health care||
2703|007|Z|professional for complete information about this product and your||
2703|008|Z|specific health needs.||
2703|009|B|||
2703|010|T|IMLUNESTRANT - ORAL||
2703|011|F|(IM-loo-NES-trant)||
2703|012|B|||
2703|013|C|COMMON BRAND NAME(S): Inluriyo||
2703|014|B|||
2703|015|U|USES:  This medication is used to treat certain types of breast||
2703|016|U|cancer. Breast cancer cells need the hormone estrogen to grow.||
2703|017|U|Imlunestrant works by blocking the effect of estrogen, slowing or||
2703|018|U|stopping the growth of cancer cells.||
2703|019|B|||
2703|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2703|021|H|from your pharmacist before you start taking imlunestrant and||
2703|022|H|each time you get a refill. If you have any questions, ask your||
2703|023|H|doctor or pharmacist.||
2703|024|H|   Take this medication by mouth on an empty stomach at least 2||
2703|025|H|hours before or 1 hour after food as directed by your doctor,||
2703|026|H|usually once daily. Swallow the tablets whole. Do not chew,||
2703|027|H|crush, or split the tablets.||
2703|028|H|   The dosage is based on your medical condition, response to||
2703|029|H|treatment, and other medications you may be taking. Be sure to||
2703|030|H|tell your doctor and pharmacist about all the products you use||
2703|031|H|(including prescription drugs, nonprescription drugs, and herbal||
2703|032|H|products).||
2703|033|H|   Use this medication regularly to get the most benefit from it.||
2703|034|H|To help you remember, take it at the same time each day.||
2703|035|H|   Do not increase your dose or use this drug more often or for||
2703|036|H|longer than prescribed. Your condition will not improve any||
2703|037|H|faster, and your risk of serious side effects will increase.||
2703|038|H|   If you vomit after taking a dose, do not take an extra dose.||
2703|039|H|Take your next dose at the regular time.||
2703|040|H|   Since this drug can be absorbed through the skin and lungs and||
2703|041|H|may harm an unborn baby, women who are pregnant or who may become||
2703|042|H|pregnant should not handle this medication or breathe the dust||
2703|043|H|from the tablets.||
2703|044|B|||
2703|045|S|SIDE EFFECTS:  Muscle/joint pain, tiredness, diarrhea,||
2703|046|S|constipation, nausea, or stomach pain may occur. If any of these||
2703|047|S|effects last or get worse, tell your doctor or pharmacist||
2703|048|S|promptly.||
2703|049|S|   Remember that this medication has been prescribed because your||
2703|050|S|doctor has judged that the benefit to you is greater than the||
2703|051|S|risk of side effects. Many people using this medication do not||
2703|052|S|have serious side effects.||
2703|053|S|   A very serious allergic reaction to this drug is rare.||
2703|054|S|However, get medical help right away if you notice any symptoms||
2703|055|S|of a serious allergic reaction, including: rash, itching/swelling||
2703|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2703|057|S|breathing.||
2703|058|S|   This is not a complete list of possible side effects. If you||
2703|059|S|notice other effects not listed above, contact your doctor or||
2703|060|S|pharmacist.||
2703|061|S|   In the US -||
2703|062|S|   Call your doctor for medical advice about side effects. You||
2703|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2703|064|S|www.fda.gov/medwatch.||
2703|065|S|   In Canada - Call your doctor for medical advice about side||
2703|066|S|effects. You may report side effects to Health Canada at||
2703|067|S|1-866-234-2345.||
2703|068|B|||
2703|069|P|PRECAUTIONS:  Before taking imlunestrant, tell your doctor or||
2703|070|P|pharmacist if you are allergic to it; or if you have any other||
2703|071|P|allergies. This product may contain inactive ingredients, which||
2703|072|P|can cause allergic reactions or other problems. Talk to your||
2703|073|P|pharmacist for more details.||
2703|074|P|   Before using this medication, tell your doctor or pharmacist||
2703|075|P|your medical history, especially of: liver disease.||
2703|076|P|   Before having surgery, tell your doctor or dentist about all||
2703|077|P|the products you use (including prescription drugs,||
2703|078|P|nonprescription drugs, and herbal products).||
2703|079|P|   Since this drug can be absorbed through the skin and lungs and||
2703|080|P|may harm an unborn baby, women who are pregnant or who may become||
2703|081|P|pregnant should not handle this medication or breathe the dust||
2703|082|P|from the tablets.||
2703|083|P|   Tell your doctor if you are pregnant or plan to become||
2703|084|P|pregnant. You should not become pregnant while using||
2703|085|P|imlunestrant. Imlunestrant may harm an unborn baby. Your doctor||
2703|086|P|should order a pregnancy test before you start this medication.||
2703|087|P|Men and women using this medication should ask about reliable||
2703|088|P|forms of birth control during treatment and for 1 week after the||
2703|089|P|last dose. If you or your partner becomes pregnant, talk to your||
2703|090|P|doctor right away about the risks and benefits of this||
2703|091|P|medication.||
2703|092|P|   It is unknown if this medication passes into breast milk.||
2703|093|P|Because of the possible risk to the infant, breastfeeding is not||
2703|094|P|recommended while using this medication and for 1 week after the||
2703|095|P|last dose. Consult your doctor before breastfeeding.||
2703|096|B|||
2703|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2703|098|I|medications work or increase your risk for serious side effects.||
2703|099|I|This document does not contain all possible drug interactions.||
2703|100|I|Keep a list of all the products you use (including||
2703|101|I|prescription/nonprescription drugs and herbal products) and share||
2703|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
2703|103|I|the dosage of any medicines without your doctor's approval.||
2703|104|B|||
2703|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2703|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2703|107|O|poison control center right away. US residents can call||
2703|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2703|109|B|||
2703|110|N|NOTES:  Do not share this medication with others.||
2703|111|N|   Lab and/or medical tests (such as liver/kidney function,||
2703|112|N|cholesterol/triglyceride levels, complete blood counts) should be||
2703|113|N|done before you start taking this medication and while you are||
2703|114|N|taking it. Keep all medical and lab appointments. Consult your||
2703|115|N|doctor for more details.||
2703|116|B|||
2703|117|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2703|118|D|remember. If it is more than 6 hours after the missed dose, skip||
2703|119|D|the missed dose. Take your next dose at the regular time. Do not||
2703|120|D|double the dose to catch up.||
2703|121|B|||
2703|122|R|STORAGE:  Store at room temperature away from light and moisture.||
2703|123|R|Do not store in the bathroom. Keep all medications away from||
2703|124|R|children and pets.||
2703|125|R|   Do not flush medications down the toilet or pour them into a||
2703|126|R|drain unless instructed to do so. Properly discard this product||
2703|127|R|when it is expired or no longer needed. Consult your pharmacist||
2703|128|R|or local waste disposal company.||
2703|129|B|||
2703|130|A|Information last revised October 2025.||
2703|131|A|Copyright(c) 2025 First Databank, Inc.||
2703|132|B|||
2704|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2704|002|Z|does NOT have all possible information about this product. This||
2704|003|Z|information does not assure that this product is safe, effective,||
2704|004|Z|or appropriate for you. This information is not individual||
2704|005|Z|medical advice and does not substitute for the advice of your||
2704|006|Z|health care professional. Always ask your health care||
2704|007|Z|professional for complete information about this product and your||
2704|008|Z|specific health needs.||
2704|009|B|||
2704|010|T|SELUMETINIB SPRINKLE CAPSULE - ORAL||
2704|011|F|(SEL-ue-ME-ti-nib)||
2704|012|B|||
2704|013|C|COMMON BRAND NAME(S): Koselugo||
2704|014|B|||
2704|015|U|USES:  Selumetinib is used to treat a type of tumor that grows on||
2704|016|U|nerves (neurofibromatosis type 1). Selumetinib belongs to a class||
2704|017|U|of drugs known as kinase inhibitors. It works by slowing or||
2704|018|U|stopping the growth of tumor cells.||
2704|019|B|||
2704|020|H|HOW TO USE:  Read the Patient Information Leaflet and||
2704|021|H|Instructions for Use leaflet if available from your pharmacist||
2704|022|H|before you start taking selumetinib and each time you get a||
2704|023|H|refill. If you have any questions, ask your doctor or pharmacist.||
2704|024|H|   Take this medication by mouth as directed by your doctor,||
2704|025|H|usually twice daily about 12 hours apart. The dosage is based on||
2704|026|H|your body size, medical condition, response to treatment, and||
2704|027|H|other medications you may be taking. Be sure to tell your doctor||
2704|028|H|and pharmacist about all the products you use (including||
2704|029|H|prescription drugs, nonprescription drugs, and herbal products).||
2704|030|H|   Do not swallow the capsules whole. Do not use the medication||
2704|031|H|if the granules inside the capsule are clumped together or stuck||
2704|032|H|to the capsule shell. Take a small amount (1 to 3 teaspoonfuls)||
2704|033|H|of soft food such as smooth yogurt or fruit puree (such as apple,||
2704|034|H|banana, pear, strawberry) in a spoon or cup. Open the capsule(s)||
2704|035|H|and sprinkle the granules onto the yogurt or fruit puree. Do not||
2704|036|H|mix with fruit puree that contains grapefruit or Seville oranges.||
2704|037|H|Swallow the mixture right away. If the mixture is not taken||
2704|038|H|within 30 minutes, discard it and prepare a new dose. Do not||
2704|039|H|prepare the mixture ahead of time for later use. If mixing the||
2704|040|H|medication in a cup, add more soft food to the cup and swallow||
2704|041|H|again to make sure all of the drug is swallowed. Do not add the||
2704|042|H|granules to any liquids. Do not chew or crush the granules.||
2704|043|H|   If you vomit after taking a dose, do not take another dose at||
2704|044|H|that time. Take your next dose at the regular time.||
2704|045|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2704|046|H|using this medication unless your doctor or pharmacist says you||
2704|047|H|may do so safely. Also avoid eating Seville oranges (often found||
2704|048|H|in marmalade). Grapefruit and Seville oranges can increase the||
2704|049|H|chance of side effects with this medicine. Ask your doctor or||
2704|050|H|pharmacist for more details.||
2704|051|H|   Take this medication regularly to get the most benefit from||
2704|052|H|it. To help you remember, take it at the same times each day.||
2704|053|H|   Do not increase your dose or use this drug more often or for||
2704|054|H|longer than prescribed. Your condition will not improve any||
2704|055|H|faster, and your risk of side effects will increase.||
2704|056|H|   Since this drug can be absorbed through the skin and lungs and||
2704|057|H|may harm an unborn baby, women who are pregnant or who may become||
2704|058|H|pregnant should not handle this medication or breathe the dust||
2704|059|H|from the capsules.||
2704|060|B|||
2704|061|S|SIDE EFFECTS:  Nausea, vomiting, tiredness, abdominal pain, or||
2704|062|S|dry skin may occur. If any of these effects last or get worse,||
2704|063|S|tell your doctor or pharmacist promptly.||
2704|064|S|   Diarrhea is a common side effect that can cause dehydration.||
2704|065|S|Tell your doctor right away if you have loose stools, and ask if||
2704|066|S|you should take anti-diarrheal medication (such as loperamide).||
2704|067|S|Drink plenty of fluids to reduce the risk of dehydration. Contact||
2704|068|S|your doctor promptly if you notice any symptoms of dehydration,||
2704|069|S|such as unusual decreased urination, unusual dry mouth/thirst,||
2704|070|S|fast heartbeat, or dizziness/lightheadedness.||
2704|071|S|   People using this medication may have serious side effects.||
2704|072|S|However, you have been prescribed this drug because your doctor||
2704|073|S|has judged that the benefit to you is greater than the risk of||
2704|074|S|side effects. Careful monitoring by your doctor may decrease your||
2704|075|S|risk.||
2704|076|S|   Tell your doctor right away if you have any serious side||
2704|077|S|effects, including: easy bleeding/bruising, muscle||
2704|078|S|pain/tenderness/weakness, signs of heart failure (such as||
2704|079|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
2704|080|S|unusual/sudden weight gain), vision changes (such as blurred||
2704|081|S|vision, decreased vision, seeing halos/colored dots), eye||
2704|082|S|pain/swelling/redness.||
2704|083|S|   A very serious allergic reaction to this drug is rare.||
2704|084|S|However, get medical help right away if you notice any symptoms||
2704|085|S|of a serious allergic reaction, including: rash, itching/swelling||
2704|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2704|087|S|breathing.||
2704|088|S|   This is not a complete list of possible side effects. If you||
2704|089|S|notice other effects not listed above, contact your doctor or||
2704|090|S|pharmacist.||
2704|091|S|   In the US -||
2704|092|S|   Call your doctor for medical advice about side effects. You||
2704|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2704|094|S|www.fda.gov/medwatch.||
2704|095|S|   In Canada - Call your doctor for medical advice about side||
2704|096|S|effects. You may report side effects to Health Canada at||
2704|097|S|1-866-234-2345.||
2704|098|B|||
2704|099|P|PRECAUTIONS:  Before taking selumetinib, tell your doctor or||
2704|100|P|pharmacist if you are allergic to it; or if you have any other||
2704|101|P|allergies. This product may contain inactive ingredients, which||
2704|102|P|can cause allergic reactions or other problems. Talk to your||
2704|103|P|pharmacist for more details.||
2704|104|P|   Before using this medication, tell your doctor or pharmacist||
2704|105|P|your medical history, especially of: bleeding/blood problems,||
2704|106|P|heart disease (such as heart failure), eye problems, kidney||
2704|107|P|problems, liver problems.||
2704|108|P|   Before having surgery, tell your doctor or dentist about all||
2704|109|P|the products you use (including prescription drugs,||
2704|110|P|nonprescription drugs, and herbal products).||
2704|111|P|   Since this drug can be absorbed through the skin and lungs and||
2704|112|P|may harm an unborn baby, women who are pregnant or who may become||
2704|113|P|pregnant should not handle this medication or breathe the dust||
2704|114|P|from the capsules.||
2704|115|P|   Tell your doctor if you are pregnant or plan to become||
2704|116|P|pregnant. You should not become pregnant while using selumetinib.||
2704|117|P|Selumetinib may harm an unborn baby. Your doctor should order a||
2704|118|P|pregnancy test before you start this medication. Men and women||
2704|119|P|using this medication should ask about reliable forms of birth||
2704|120|P|control during treatment and for 1 week after the last dose. If||
2704|121|P|you or your partner becomes pregnant, talk to your doctor right||
2704|122|P|away about the risks and benefits of this medication.||
2704|123|P|   It is unknown if this drug passes into breast milk. Because of||
2704|124|P|the possible risk to the infant, breastfeeding is not recommended||
2704|125|P|while using this drug and for 1 week after the last dose. Consult||
2704|126|P|your doctor before breastfeeding.||
2704|127|B|||
2704|128|I|DRUG INTERACTIONS:  See also How to Use section.||
2704|129|I|   Drug interactions may change how your medications work or||
2704|130|I|increase your risk for serious side effects. This document does||
2704|131|I|not contain all possible drug interactions. Keep a list of all||
2704|132|I|the products you use (including prescription/nonprescription||
2704|133|I|drugs and herbal products) and share it with your doctor and||
2704|134|I|pharmacist. Do not start, stop, or change the dosage of any||
2704|135|I|medicines without your doctor's approval.||
2704|136|I|   Other medications can affect the removal of selumetinib from||
2704|137|I|your body, which may affect how selumetinib works. Examples||
2704|138|I|include rifamycins (such as rifampin, rifabutin), St. John's||
2704|139|I|wort, drugs used to treat seizures (such as carbamazepine,||
2704|140|I|phenytoin), among others.||
2704|141|B|||
2704|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2704|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2704|144|O|poison control center right away. US residents can call||
2704|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2704|146|B|||
2704|147|N|NOTES:  Do not share this medication with others.||
2704|148|N|   Lab and/or medical tests (such as heart/kidney/liver function,||
2704|149|N|skin/eye exams, CPK levels) should be done before you start||
2704|150|N|taking this medication and while you are taking it. Keep all||
2704|151|N|medical and lab appointments.||
2704|152|B|||
2704|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2704|154|D|remember. If it is within 6 hours of the next dose, skip the||
2704|155|D|missed dose. Take your next dose at the regular time. Do not||
2704|156|D|double the dose to catch up.||
2704|157|B|||
2704|158|R|STORAGE:  Store in the original bottle at room temperature away||
2704|159|R|from heat, light, and moisture. Do not store in the bathroom.||
2704|160|R|Keep the drying agent (desiccant) in the bottle. Tightly close||
2704|161|R|the bottle when not in use. Keep all medications away from||
2704|162|R|children and pets.||
2704|163|R|   Do not flush medications down the toilet or pour them into a||
2704|164|R|drain unless instructed to do so. Properly discard this product||
2704|165|R|when it is expired or no longer needed. Consult your pharmacist||
2704|166|R|or local waste disposal company.||
2704|167|B|||
2704|168|A|Information last revised October 2025.||
2704|169|A|Copyright(c) 2025 First Databank, Inc.||
2704|170|B|||
2705|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2705|002|Z|does NOT have all possible information about this product. This||
2705|003|Z|information does not assure that this product is safe, effective,||
2705|004|Z|or appropriate for you. This information is not individual||
2705|005|Z|medical advice and does not substitute for the advice of your||
2705|006|Z|health care professional. Always ask your health care||
2705|007|Z|professional for complete information about this product and your||
2705|008|Z|specific health needs.||
2705|009|B|||
2705|010|T|REMIBRUTINIB - ORAL||
2705|011|F|(REM-i-BROO-tin-ib)||
2705|012|B|||
2705|013|C|COMMON BRAND NAME(S): Rhapsido||
2705|014|B|||
2705|015|U|USES:  This medication is used to treat hives from an unknown||
2705|016|U|cause (chronic spontaneous urticaria-CSU). Remibrutinib belongs||
2705|017|U|to a class of drugs known as kinase inhibitors. It works by||
2705|018|U|blocking a certain natural protein in your body that may cause||
2705|019|U|inflammation and swelling in people with CSU.||
2705|020|B|||
2705|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2705|022|H|from your pharmacist before you start taking remibrutinib and||
2705|023|H|each time you get a refill. If you have any questions, ask your||
2705|024|H|doctor or pharmacist.||
2705|025|H|   Take this medication by mouth with or without food as directed||
2705|026|H|by your doctor, usually twice daily. Swallow the tablets whole||
2705|027|H|with water. Do not crush, chew, or split the tablets.||
2705|028|H|   Use this medication regularly to get the most benefit from it.||
2705|029|H|To help you remember, take it at the same times each day.||
2705|030|H|   Do not increase your dose or use this drug more often or for||
2705|031|H|longer than prescribed. Your condition will not improve any||
2705|032|H|faster, and your risk of side effects will increase.||
2705|033|H|   Tell your doctor if your condition does not get better or if||
2705|034|H|it gets worse.||
2705|035|B|||
2705|036|S|SIDE EFFECTS:  Headache, stuffy/runny nose, or sore throat may||
2705|037|S|occur. If any of these effects last or get worse, tell your||
2705|038|S|doctor or pharmacist promptly.||
2705|039|S|   Remember that this medication has been prescribed because your||
2705|040|S|doctor has judged that the benefit to you is greater than the||
2705|041|S|risk of side effects. Many people using this medication do not||
2705|042|S|have serious side effects.||
2705|043|S|   Tell your doctor right away if you have any serious side||
2705|044|S|effects, including: easy bleeding/bruising, black/bloody stools,||
2705|045|S|pink/bloody urine.||
2705|046|S|   A very serious allergic reaction to this drug is rare.||
2705|047|S|However, get medical help right away if you notice any symptoms||
2705|048|S|of a serious allergic reaction, including: rash, itching/swelling||
2705|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2705|050|S|breathing.||
2705|051|S|   This is not a complete list of possible side effects. If you||
2705|052|S|notice other effects not listed above, contact your doctor or||
2705|053|S|pharmacist.||
2705|054|S|   In the US -||
2705|055|S|   Call your doctor for medical advice about side effects. You||
2705|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2705|057|S|www.fda.gov/medwatch.||
2705|058|S|   In Canada - Call your doctor for medical advice about side||
2705|059|S|effects. You may report side effects to Health Canada at||
2705|060|S|1-866-234-2345.||
2705|061|B|||
2705|062|P|PRECAUTIONS:  Before taking remibrutinib, tell your doctor or||
2705|063|P|pharmacist if you are allergic to it; or if you have any other||
2705|064|P|allergies. This product may contain inactive ingredients, which||
2705|065|P|can cause allergic reactions or other problems. Talk to your||
2705|066|P|pharmacist for more details.||
2705|067|P|   Before using this medication, tell your doctor or pharmacist||
2705|068|P|your medical history, especially of: liver disease.||
2705|069|P|   Tell your health care professional that you are using||
2705|070|P|remibrutinib before having any immunizations/vaccinations.||
2705|071|P|   Before having surgery, tell your doctor or dentist about all||
2705|072|P|the products you use (including prescription drugs,||
2705|073|P|nonprescription drugs, and herbal products). Your doctor or||
2705|074|P|dentist may tell you to stop this medication 3 to 7 days before||
2705|075|P|and after certain medical or surgical procedures.||
2705|076|P|   During pregnancy, this medication should be used only when||
2705|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
2705|078|P|   It is unknown if this medication passes into breast milk.||
2705|079|P|Consult your doctor before breastfeeding.||
2705|080|B|||
2705|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2705|082|I|medications work or increase your risk for serious side effects.||
2705|083|I|This document does not contain all possible drug interactions.||
2705|084|I|Keep a list of all the products you use (including||
2705|085|I|prescription/nonprescription drugs and herbal products) and share||
2705|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
2705|087|I|the dosage of any medicines without your doctor's approval.||
2705|088|I|   Some products that may interact with this drug are: other||
2705|089|I|drugs that can cause bleeding/bruising (including antiplatelet||
2705|090|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
2705|091|I|"blood thinners" such as warfarin/dabigatran).||
2705|092|I|   Aspirin can increase the risk of bleeding when used with this||
2705|093|I|medication. However, if your doctor has told you to take low-dose||
2705|094|I|aspirin to prevent heart attack or stroke (usually 81-162||
2705|095|I|milligrams a day), you should keep taking the aspirin unless your||
2705|096|I|doctor tells you not to. Ask your doctor or pharmacist for more||
2705|097|I|details.||
2705|098|B|||
2705|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2705|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2705|101|O|poison control center right away. US residents can call||
2705|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2705|103|B|||
2705|104|N|NOTES:  Do not share this medication with others.||
2705|105|B|||
2705|106|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2705|107|D|next dose at the regular time. Do not double the dose to catch||
2705|108|D|up.||
2705|109|B|||
2705|110|R|STORAGE:  Store in the original bottle at room temperature away||
2705|111|R|from light and moisture. Do not store in the bathroom. Keep all||
2705|112|R|medications away from children and pets.||
2705|113|R|   Do not flush medications down the toilet or pour them into a||
2705|114|R|drain unless instructed to do so. Properly discard this product||
2705|115|R|when it is expired or no longer needed. Consult your pharmacist||
2705|116|R|or local waste disposal company.||
2705|117|B|||
2705|118|A|Information last revised October 2025.||
2705|119|A|Copyright(c) 2025 First Databank, Inc.||
2705|120|B|||
2706|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2706|002|Z|does NOT have all possible information about this product. This||
2706|003|Z|information does not assure that this product is safe, effective,||
2706|004|Z|or appropriate for you. This information is not individual||
2706|005|Z|medical advice and does not substitute for the advice of your||
2706|006|Z|health care professional. Always ask your health care||
2706|007|Z|professional for complete information about this product and your||
2706|008|Z|specific health needs.||
2706|009|B|||
2706|010|T|NERANDOMILAST - ORAL||
2706|011|B|||
2706|012|C|COMMON BRAND NAME(S): Jascayd||
2706|013|B|||
2706|014|U|USES:  Nerandomilast is used to treat a certain lung disease||
2706|015|U|called idiopathic pulmonary fibrosis (IPF). This disease causes||
2706|016|U|the lungs to get scarred and become stiff, making it hard to||
2706|017|U|breathe. Nerandomilast may help slow down the worsening of your||
2706|018|U|IPF. Nerandomilast belongs to a class of drugs known as||
2706|019|U|phosphodiesterase 4 (PDE4) inhibitors.||
2706|020|B|||
2706|021|H|HOW TO USE:  Take this medication by mouth with or without food||
2706|022|H|as directed by your doctor, usually twice daily (about 12 hours||
2706|023|H|apart). Swallow the tablets whole. Do not crush or chew the||
2706|024|H|tablets.||
2706|025|H|   The dosage is based on your medical condition, response to||
2706|026|H|treatment, and other medications you may be taking. Be sure to||
2706|027|H|tell your doctor and pharmacist about all the products you use||
2706|028|H|(including prescription drugs, nonprescription drugs, and herbal||
2706|029|H|products).||
2706|030|H|   If you have trouble swallowing the tablet whole, place the||
2706|031|H|tablet in a glass of non-carbonated, room temperature water (3 to||
2706|032|H|4 ounces/90 to 120 milliliters). Do not crush the tablet. Stir||
2706|033|H|the mixture well until the tablet breaks into very small pieces.||
2706|034|H|The tablet will not completely dissolve. Drink the mixture right||
2706|035|H|away or within 2 hours of mixing. If you do not drink the mixture||
2706|036|H|right away, make sure to stir the mixture again right before||
2706|037|H|drinking it. After drinking the mixture, rinse the glass with||
2706|038|H|water (3 to 4 ounces/90 to 120 milliliters) and drink the rinse||
2706|039|H|water to make sure you are getting all of the drug.||
2706|040|H|   Use this medication regularly to get the most benefit from it.||
2706|041|H|To help you remember, take it at the same times each day.||
2706|042|H|   Tell your doctor if your condition gets worse.||
2706|043|B|||
2706|044|S|SIDE EFFECTS:  Diarrhea, decreased appetite, or tiredness may||
2706|045|S|occur. If any of these effects last or get worse, tell your||
2706|046|S|doctor or pharmacist promptly.||
2706|047|S|   Remember that this medication has been prescribed because your||
2706|048|S|doctor has judged that the benefit to you is greater than the||
2706|049|S|risk of side effects. Many people using this medication do not||
2706|050|S|have serious side effects.||
2706|051|S|   A very serious allergic reaction to this drug is rare.||
2706|052|S|However, get medical help right away if you notice any symptoms||
2706|053|S|of a serious allergic reaction, including: rash, itching/swelling||
2706|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2706|055|S|breathing.||
2706|056|S|   This is not a complete list of possible side effects. If you||
2706|057|S|notice other effects not listed above, contact your doctor or||
2706|058|S|pharmacist.||
2706|059|S|   In the US -||
2706|060|S|   Call your doctor for medical advice about side effects. You||
2706|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2706|062|S|www.fda.gov/medwatch.||
2706|063|S|   In Canada - Call your doctor for medical advice about side||
2706|064|S|effects. You may report side effects to Health Canada at||
2706|065|S|1-866-234-2345.||
2706|066|B|||
2706|067|P|PRECAUTIONS:  Before taking nerandomilast, tell your doctor or||
2706|068|P|pharmacist if you are allergic to it; or if you have any other||
2706|069|P|allergies. This product may contain inactive ingredients, which||
2706|070|P|can cause allergic reactions or other problems. Talk to your||
2706|071|P|pharmacist for more details.||
2706|072|P|   Before using this medication, tell your doctor or pharmacist||
2706|073|P|your medical history, especially of: kidney disease, liver||
2706|074|P|disease.||
2706|075|P|   Before having surgery, tell your doctor or dentist about all||
2706|076|P|the products you use (including prescription drugs,||
2706|077|P|nonprescription drugs, and herbal products).||
2706|078|P|   During pregnancy, this medication should be used only when||
2706|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
2706|080|P|   It is unknown if this medication passes into breast milk.||
2706|081|P|Consult your doctor before breastfeeding.||
2706|082|B|||
2706|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2706|084|I|medications work or increase your risk for serious side effects.||
2706|085|I|This document does not contain all possible drug interactions.||
2706|086|I|Keep a list of all the products you use (including||
2706|087|I|prescription/nonprescription drugs and herbal products) and share||
2706|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
2706|089|I|the dosage of any medicines without your doctor's approval.||
2706|090|I|   Other medications can affect the removal of nerandomilast from||
2706|091|I|your body, which may affect how nerandomilast works. Examples||
2706|092|I|include rifamycins (such as rifampin, rifabutin), certain drugs||
2706|093|I|used to treat seizures (such as carbamazepine, phenobarbital,||
2706|094|I|phenytoin, primidone), St. John's wort, among others.||
2706|095|B|||
2706|096|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2706|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2706|098|O|poison control center right away. US residents can call||
2706|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2706|100|B|||
2706|101|N|NOTES:  Do not share this medication with others.||
2706|102|B|||
2706|103|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2706|104|D|next dose at the regular time. Do not double the dose to catch||
2706|105|D|up.||
2706|106|B|||
2706|107|R|STORAGE:  Store in the original bottle at room temperature away||
2706|108|R|from light and moisture. Do not store in the bathroom. Keep all||
2706|109|R|medications away from children and pets.||
2706|110|R|   Do not flush medications down the toilet or pour them into a||
2706|111|R|drain unless instructed to do so. Properly discard this product||
2706|112|R|when it is expired or no longer needed. Consult your pharmacist||
2706|113|R|or local waste disposal company.||
2706|114|B|||
2706|115|A|Information last revised October 2025.||
2706|116|A|Copyright(c) 2025 First Databank, Inc.||
2706|117|B|||
2707|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2707|002|Z|does NOT have all possible information about this product. This||
2707|003|Z|information does not assure that this product is safe, effective,||
2707|004|Z|or appropriate for you. This information is not individual||
2707|005|Z|medical advice and does not substitute for the advice of your||
2707|006|Z|health care professional. Always ask your health care||
2707|007|Z|professional for complete information about this product and your||
2707|008|Z|specific health needs.||
2707|009|B|||
2707|010|T|ELAMIPRETIDE - INJECTION||
2707|011|F|(El-a-MIP-re-tide)||
2707|012|B|||
2707|013|C|COMMON BRAND NAME(S): Forzinity||
2707|014|B|||
2707|015|U|USES:  This medication is used to improve muscle strength in||
2707|016|U|people with a certain rare genetic problem (Barth syndrome).||
2707|017|U|Elamipretide works by helping the body make more energy.||
2707|018|B|||
2707|019|H|HOW TO USE:  Read the Instructions for Use if available from your||
2707|020|H|pharmacist before you start using this medication and each time||
2707|021|H|you get a refill. Ask your health care professional how to||
2707|022|H|prepare and use this medication. If you have any questions, ask||
2707|023|H|your doctor or pharmacist.||
2707|024|H|   Inject this medication under the skin as directed by your||
2707|025|H|doctor, usually once daily. The injection is given in the outer||
2707|026|H|thigh or abdomen (except for a 2-inch area around your belly||
2707|027|H|button). The dosage is based on your medical condition and||
2707|028|H|response to treatment.||
2707|029|H|   Take the medication out of the refrigerator at least 10||
2707|030|H|minutes before you inject it to allow it to reach room||
2707|031|H|temperature. Do not warm up this medication any other way (for||
2707|032|H|example, do not heat it in the microwave, place it in hot water,||
2707|033|H|or leave it in direct sunlight). Before using, check this product||
2707|034|H|for cloudiness, particles, or discoloration. If you see any of||
2707|035|H|these things, do not use the liquid. Before injecting each dose,||
2707|036|H|clean the skin you are going to inject into (the injection site)||
2707|037|H|with rubbing alcohol. Change the injection site each time to||
2707|038|H|lessen injury under the skin. Do not inject into skin that is||
2707|039|H|tender, bruised, red, hard, or damaged or into scars or stretch||
2707|040|H|marks. To lessen bruising, do not rub the injection site after a||
2707|041|H|shot. Learn how to store and discard medical supplies safely.||
2707|042|H|   Use this medication regularly to get the most benefit from it.||
2707|043|H|To help you remember, use it at the same time each day.||
2707|044|H|   Do not increase your dose or use this drug more often or for||
2707|045|H|longer than prescribed. Your condition will not improve any||
2707|046|H|faster, and your risk of side effects will increase.||
2707|047|H|   Tell your doctor if your condition gets worse.||
2707|048|B|||
2707|049|S|SIDE EFFECTS:  Redness, swelling, itching, rash, pain, or||
2707|050|S|bruising at the injection site may occur. If any of these effects||
2707|051|S|last or get worse, tell your doctor or pharmacist promptly.||
2707|052|S|   Remember that this medication has been prescribed because your||
2707|053|S|doctor has judged that the benefit to you is greater than the||
2707|054|S|risk of side effects. Many people using this medication do not||
2707|055|S|have serious side effects.||
2707|056|S|   A very serious allergic reaction to this drug is rare.||
2707|057|S|However, get medical help right away if you notice any symptoms||
2707|058|S|of a serious allergic reaction, including: rash, itching/swelling||
2707|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2707|060|S|breathing.||
2707|061|S|   This is not a complete list of possible side effects. If you||
2707|062|S|notice other effects not listed above, contact your doctor or||
2707|063|S|pharmacist.||
2707|064|S|   In the US -||
2707|065|S|   Call your doctor for medical advice about side effects. You||
2707|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2707|067|S|www.fda.gov/medwatch.||
2707|068|S|   In Canada - Call your doctor for medical advice about side||
2707|069|S|effects. You may report side effects to Health Canada at||
2707|070|S|1-866-234-2345.||
2707|071|B|||
2707|072|P|PRECAUTIONS:  Before using elamipretide, tell your doctor or||
2707|073|P|pharmacist if you are allergic to it; or if you have any other||
2707|074|P|allergies. This product may contain inactive ingredients (such as||
2707|075|P|benzyl alcohol), which can cause allergic reactions or other||
2707|076|P|problems. Talk to your pharmacist for more details.||
2707|077|P|   Before using this medication, tell your doctor or pharmacist||
2707|078|P|your medical history, especially of: kidney disease.||
2707|079|P|   Before having surgery, tell your doctor or dentist about all||
2707|080|P|the products you use (including prescription drugs,||
2707|081|P|nonprescription drugs, and herbal products).||
2707|082|P|   This medication is not usually used by women. It is unlikely||
2707|083|P|to be used during pregnancy or breastfeeding. Consult your doctor||
2707|084|P|if you have any questions about this medication.||
2707|085|B|||
2707|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2707|087|I|medications work or increase your risk for serious side effects.||
2707|088|I|This document does not contain all possible drug interactions.||
2707|089|I|Keep a list of all the products you use (including||
2707|090|I|prescription/nonprescription drugs and herbal products) and share||
2707|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
2707|092|I|the dosage of any medicines without your doctor's approval.||
2707|093|B|||
2707|094|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2707|095|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2707|096|O|poison control center right away. US residents can call||
2707|097|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2707|098|B|||
2707|099|N|NOTES:  Do not share this medication with others.||
2707|100|N|   Lab and/or medical tests (such as kidney function) should be||
2707|101|N|done while you are using this medication. Keep all medical and||
2707|102|N|lab appointments.||
2707|103|B|||
2707|104|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
2707|105|D|next dose at the regular time. Do not double the dose to catch||
2707|106|D|up.||
2707|107|B|||
2707|108|R|STORAGE:  Store unopened vials in the refrigerator. Do not||
2707|109|R|freeze. Once the vial is opened, it may be stored in the||
2707|110|R|refrigerator or at room temperature and expires after 8 days.||
2707|111|R|Keep all medications away from children and pets.||
2707|112|R|   Do not flush medications down the toilet or pour them into a||
2707|113|R|drain unless instructed to do so. Properly discard this product||
2707|114|R|when it is expired or no longer needed. Consult your pharmacist||
2707|115|R|or local waste disposal company.||
2707|116|B|||
2707|117|A|Information last revised October 2025.||
2707|118|A|Copyright(c) 2025 First Databank, Inc.||
2707|119|B|||
2708|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2708|002|Z|does NOT have all possible information about this product. This||
2708|003|Z|information does not assure that this product is safe, effective,||
2708|004|Z|or appropriate for you. This information is not individual||
2708|005|Z|medical advice and does not substitute for the advice of your||
2708|006|Z|health care professional. Always ask your health care||
2708|007|Z|professional for complete information about this product and your||
2708|008|Z|specific health needs.||
2708|009|B|||
2708|010|T|LEVOFLOXACIN/DEXAMETHASONE DROPS - OPHTHALMIC||
2708|011|F|(LEE-voe-FLOX-a-sin/DEX-a-METH-a-sone)||
2708|012|B|||
2708|013|U|USES:  This combination medication is used after cataract surgery||
2708|014|U|to prevent bacterial eye infections. It is also used to prevent||
2708|015|U|and treat swelling after cataract surgery. It contains 2||
2708|016|U|medications: levofloxacin and dexamethasone. Levofloxacin belongs||
2708|017|U|to a class of drugs known as quinolone antibiotics. It works by||
2708|018|U|stopping the growth of bacteria. Dexamethasone belongs to a class||
2708|019|U|of drugs called corticosteroids. It works by reducing swelling,||
2708|020|U|itching, and redness.||
2708|021|U|   This medication prevents only bacterial eye infections. It||
2708|022|U|will not work for other types of eye infections. Using any||
2708|023|U|antibiotic when it is not needed can cause it to not work for||
2708|024|U|future infections.||
2708|025|B|||
2708|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2708|027|H|from your pharmacist before you start using this medication and||
2708|028|H|each time you get a refill. If you have any questions, ask your||
2708|029|H|doctor or pharmacist.||
2708|030|H|   Use this medication in the affected eye(s) as directed by your||
2708|031|H|doctor, usually every 6 hours for 7 days.||
2708|032|H|   To apply eye drops, wash hands first. To avoid contamination,||
2708|033|H|do not touch the dropper tip or let it touch your eye or any||
2708|034|H|other surface.||
2708|035|H|   Do not wear contact lenses while you are using this||
2708|036|H|medication. Sterilize contact lenses according to the||
2708|037|H|manufacturer's directions, and check with your doctor before you||
2708|038|H|begin using them again.||
2708|039|H|   Tilt your head back, look upward, and pull down the lower||
2708|040|H|eyelid to make a pouch. Hold the dropper directly over your eye||
2708|041|H|and place one drop into the pouch. Look downward, gently close||
2708|042|H|your eyes, and place one finger at the corner of your eye (near||
2708|043|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
2708|044|H|opening your eyes. This will prevent the medication from draining||
2708|045|H|out. Try not to blink or rub your eye. Repeat these steps if your||
2708|046|H|dose is for more than one drop. If directed to use this||
2708|047|H|medication in both eyes, repeat these steps for your other eye.||
2708|048|H|Do not rinse the dropper. Replace the dropper cap after each use.||
2708|049|H|   If you are using another kind of eye medication (such as drops||
2708|050|H|or ointments), wait at least 15 minutes before applying other||
2708|051|H|medications. Use eye drops before eye ointments to allow the||
2708|052|H|drops to enter the eye.||
2708|053|H|   Wait several minutes for your vision to clear before driving||
2708|054|H|or operating machinery.||
2708|055|H|   Use this medication regularly to get the most benefit from it.||
2708|056|H|To help you remember, use it at the same times each day. Continue||
2708|057|H|to use this medication for the full time prescribed, even if||
2708|058|H|symptoms disappear after a few days.||
2708|059|H|   Tell your doctor if your condition does not get better or if||
2708|060|H|it gets worse.||
2708|061|B|||
2708|062|S|SIDE EFFECTS:  Eye discomfort, stinging/burning of the eyes,||
2708|063|S|temporary blurred vision, or headache may occur. If any of these||
2708|064|S|effects last or get worse, tell your doctor or pharmacist||
2708|065|S|promptly.||
2708|066|S|   Remember that this medication has been prescribed because your||
2708|067|S|doctor has judged that the benefit to you is greater than the||
2708|068|S|risk of side effects. Many people using this medication do not||
2708|069|S|have serious side effects.||
2708|070|S|   Long-term or repeated use of this medication may put you at||
2708|071|S|greater risk of developing an eye infection or other eye problems||
2708|072|S|(such as glaucoma, cataracts). Do not use this medication for||
2708|073|S|longer than prescribed. Tell your doctor right away if you notice||
2708|074|S|any of the following: new or worsening eye symptoms (such as||
2708|075|S|discharge, swelling), eye pain, vision changes.||
2708|076|S|   A very serious allergic reaction to this drug is rare.||
2708|077|S|However, get medical help right away if you notice any symptoms||
2708|078|S|of a serious allergic reaction, including: rash, itching/swelling||
2708|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2708|080|S|breathing.||
2708|081|S|   This is not a complete list of possible side effects. If you||
2708|082|S|notice other effects not listed above, contact your doctor or||
2708|083|S|pharmacist.||
2708|084|S|   In the US -||
2708|085|S|   Call your doctor for medical advice about side effects. You||
2708|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2708|087|S|www.fda.gov/medwatch.||
2708|088|S|   In Canada - Call your doctor for medical advice about side||
2708|089|S|effects. You may report side effects to Health Canada at||
2708|090|S|1-866-234-2345.||
2708|091|B|||
2708|092|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
2708|093|P|pharmacist if you are allergic to levofloxacin or dexamethasone;||
2708|094|P|or if you have any other allergies. This product may contain||
2708|095|P|inactive ingredients, which can cause allergic reactions or other||
2708|096|P|problems. Talk to your pharmacist for more details.||
2708|097|P|   Before using this medication, tell your doctor or pharmacist||
2708|098|P|your medical history, especially of: diabetes, eye infections,||
2708|099|P|glaucoma.||
2708|100|P|   After you apply this drug, your vision may become temporarily||
2708|101|P|blurred. Do not drive, use machinery, or do anything that needs||
2708|102|P|clear vision until you can do it safely.||
2708|103|P|   Before having surgery, tell your doctor or dentist about all||
2708|104|P|the products you use (including prescription drugs,||
2708|105|P|nonprescription drugs, and herbal products).||
2708|106|P|   During pregnancy, this medication should be used only when||
2708|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
2708|108|P|   It is unknown if this medication passes into breast milk.||
2708|109|P|Consult your doctor before breastfeeding.||
2708|110|B|||
2708|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2708|112|I|medications work or increase your risk for serious side effects.||
2708|113|I|This document does not contain all possible drug interactions.||
2708|114|I|Keep a list of all the products you use (including||
2708|115|I|prescription/nonprescription drugs and herbal products) and share||
2708|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
2708|117|I|the dosage of any medicines without your doctor's approval.||
2708|118|B|||
2708|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
2708|120|O|has overdosed and has serious symptoms such as passing out or||
2708|121|O|trouble breathing, call 911. Otherwise, call a poison control||
2708|122|O|center right away. US residents can call 1-800-222-1222. Canada||
2708|123|O|residents can call 1-844-764-7669.||
2708|124|B|||
2708|125|N|NOTES:  Do not share this medication with others.||
2708|126|N|   This medication has been prescribed for your current condition||
2708|127|N|only. Do not use it later for another infection unless your||
2708|128|N|doctor tells you to.||
2708|129|N|   If you are using this medication for 10 days or longer, lab||
2708|130|N|and/or medical tests (such as eye exams) should be done while you||
2708|131|N|are using it. Keep all medical and lab appointments. Consult your||
2708|132|N|doctor for more details.||
2708|133|B|||
2708|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
2708|135|D|If it is near the time of the next dose, skip the missed dose.||
2708|136|D|Use your next dose at the regular time. Do not double the dose to||
2708|137|D|catch up.||
2708|138|B|||
2708|139|R|STORAGE:  Store at room temperature. Once the bottle is opened,||
2708|140|R|this medication expires after 28 days. Keep all medications away||
2708|141|R|from children and pets.||
2708|142|R|   Do not flush medications down the toilet or pour them into a||
2708|143|R|drain unless instructed to do so. Properly discard this product||
2708|144|R|when it is expired or no longer needed. Consult your pharmacist||
2708|145|R|or local waste disposal company.||
2708|146|B|||
2708|147|A|Information last revised October 2025.||
2708|148|A|Copyright(c) 2025 First Databank, Inc.||
2708|149|B|||
2709|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2709|002|Z|does NOT have all possible information about this product. This||
2709|003|Z|information does not assure that this product is safe, effective,||
2709|004|Z|or appropriate for you. This information is not individual||
2709|005|Z|medical advice and does not substitute for the advice of your||
2709|006|Z|health care professional. Always ask your health care||
2709|007|Z|professional for complete information about this product and your||
2709|008|Z|specific health needs.||
2709|009|B|||
2709|010|T|CELECOXIB SUSPENSION - ORAL||
2709|011|F|(SEL-e-KOX-ib)||
2709|012|B|||
2709|013|C|COMMON BRAND NAME(S): Vyscoxa||
2709|014|B|||
2709|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
2709|016|W|celecoxib) may rarely increase the risk of a heart attack or||
2709|017|W|stroke. This effect can happen at any time while taking this drug||
2709|018|W|but is more likely if you take it for a long time. The risk may||
2709|019|W|be greater in older adults or if you have heart disease or||
2709|020|W|increased risk for heart disease (for example, due to smoking,||
2709|021|W|family history of heart disease, or conditions such as high blood||
2709|022|W|pressure or diabetes). Do not take this drug right before or||
2709|023|W|after heart bypass surgery (CABG).||
2709|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
2709|025|W|bleeding from the stomach or intestines. This effect can occur||
2709|026|W|without warning symptoms at any time while taking this drug.||
2709|027|W|Older adults may be at higher risk for this effect.||
2709|028|W|   Stop taking celecoxib and get medical help right away if you||
2709|029|W|notice any of these rare but serious side effects:||
2709|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
2709|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
2709|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
2709|033|W|side of the body, trouble speaking, sudden vision changes.||
2709|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
2709|035|W|of taking this drug.||
2709|036|B|||
2709|037|U|USES:  See also Warning section.||
2709|038|U|   This medication is used to reduce pain, swelling, and joint||
2709|039|U|stiffness from arthritis. Celecoxib is a nonsteroidal||
2709|040|U|anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor.||
2709|041|U|It works by blocking your body's production of certain natural||
2709|042|U|substances that cause inflammation. This effect helps to decrease||
2709|043|U|pain and swelling.||
2709|044|U|   Ask your doctor about non-drug treatments and/or using other||
2709|045|U|medications to treat your pain.||
2709|046|B|||
2709|047|H|HOW TO USE:  Read the Medication Guide provided by your||
2709|048|H|pharmacist before you start using celecoxib and each time you get||
2709|049|H|a refill. If you have any questions, ask your doctor or||
2709|050|H|pharmacist.||
2709|051|H|   Take this medication by mouth on an empty stomach (at least 2||
2709|052|H|hours before or 1 hour after food) as directed by your doctor,||
2709|053|H|usually once or twice daily. Shake the bottle well before each||
2709|054|H|dose. Carefully measure the dose using a special measuring||
2709|055|H|device/spoon. Do not use a household spoon because you may not||
2709|056|H|get the correct dose.||
2709|057|H|   The dosage is based on your medical condition and response to||
2709|058|H|treatment. Children's dosage is also based on weight. To reduce||
2709|059|H|your risk of stomach bleeding and other side effects, take this||
2709|060|H|medication at the lowest effective dose for the shortest possible||
2709|061|H|time. Do not increase your dose or take this drug more often or||
2709|062|H|for longer than prescribed.||
2709|063|H|   It may take up to two weeks of taking this drug regularly||
2709|064|H|until you get the full benefit.||
2709|065|H|   Tell your doctor if your condition gets worse.||
2709|066|B|||
2709|067|S|SIDE EFFECTS:  See also Warning section.||
2709|068|S|   Upset stomach or gas may occur. If either of these effects||
2709|069|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
2709|070|S|   Remember that this medication has been prescribed because your||
2709|071|S|doctor has judged that the benefit to you is greater than the||
2709|072|S|risk of side effects. Many people using this medication do not||
2709|073|S|have serious side effects.||
2709|074|S|   This medication may raise your blood pressure. Check your||
2709|075|S|blood pressure regularly and tell your doctor if the results are||
2709|076|S|high.||
2709|077|S|   Tell your doctor right away if you have any serious side||
2709|078|S|effects, including: pain/swelling/warmth in the groin/calf, signs||
2709|079|S|of kidney problems (such as change in the amount of urine),||
2709|080|S|difficult/painful swallowing, symptoms of heart failure (such as||
2709|081|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
2709|082|S|gain).||
2709|083|S|   This drug may rarely cause serious (possibly fatal) liver||
2709|084|S|disease. Get medical help right away if you have any symptoms of||
2709|085|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
2709|086|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
2709|087|S|urine.||
2709|088|S|   A very serious allergic reaction to this drug is rare.||
2709|089|S|However, get medical help right away if you notice any symptoms||
2709|090|S|of a serious allergic reaction, including: fever, swollen lymph||
2709|091|S|nodes, rash, itching/swelling (especially of the||
2709|092|S|face/tongue/throat), severe dizziness, trouble breathing.||
2709|093|S|   This is not a complete list of possible side effects. If you||
2709|094|S|notice other effects not listed above, contact your doctor or||
2709|095|S|pharmacist.||
2709|096|S|   In the US -||
2709|097|S|   Call your doctor for medical advice about side effects. You||
2709|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2709|099|S|www.fda.gov/medwatch.||
2709|100|S|   In Canada - Call your doctor for medical advice about side||
2709|101|S|effects. You may report side effects to Health Canada at||
2709|102|S|1-866-234-2345.||
2709|103|B|||
2709|104|P|PRECAUTIONS:  See also Warning section.||
2709|105|P|   Before taking celecoxib, tell your doctor or pharmacist if you||
2709|106|P|are allergic to it; or to aspirin or other NSAIDs (such as||
2709|107|P|ibuprofen, naproxen); or if you have any other allergies. This||
2709|108|P|product may contain inactive ingredients, which can cause||
2709|109|P|allergic reactions or other problems. Talk to your pharmacist for||
2709|110|P|more details.||
2709|111|P|   Before using this medication, tell your doctor or pharmacist||
2709|112|P|your medical history, especially of: asthma (including a history||
2709|113|P|of worsening breathing with runny/stuffy nose after taking||
2709|114|P|aspirin or other NSAIDs), bleeding/clotting problems, blood||
2709|115|P|disorders (such as anemia), growths in the nose (nasal polyps),||
2709|116|P|heart disease (such as previous heart attack), high blood||
2709|117|P|pressure, liver disease, stroke, swelling (edema, fluid||
2709|118|P|retention), stomach/intestine/esophagus problems (such as||
2709|119|P|bleeding, ulcers, recurring heartburn).||
2709|120|P|   Kidney problems can sometimes occur with the use of NSAID||
2709|121|P|medications, including celecoxib. Problems are more likely to||
2709|122|P|occur if you are dehydrated, have heart failure or kidney||
2709|123|P|disease, are an older adult, or if you take certain medications||
2709|124|P|(see also Drug Interactions section). Drink plenty of fluids as||
2709|125|P|directed by your doctor to prevent dehydration and tell your||
2709|126|P|doctor right away if you have any unusual change in the amount of||
2709|127|P|urine.||
2709|128|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
2709|129|P|and tobacco, especially when combined with this medicine, may||
2709|130|P|increase your risk for stomach bleeding. Limit alcohol and stop||
2709|131|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
2709|132|P|may safely drink.||
2709|133|P|   Before having surgery, tell your doctor or dentist about all||
2709|134|P|the products you use (including prescription drugs,||
2709|135|P|nonprescription drugs, and herbal products).||
2709|136|P|   Older adults may be at greater risk for stomach/intestinal||
2709|137|P|bleeding, kidney problems, heart attack, and stroke while using||
2709|138|P|this drug.||
2709|139|P|   Children with a certain type of arthritis (systemic onset||
2709|140|P|juvenile rheumatoid arthritis) may be at greater risk for a very||
2709|141|P|serious bleeding/clotting problem (disseminated intravascular||
2709|142|P|coagulation) while using this drug. Get medical help right away||
2709|143|P|if your child develops sudden bleeding/bruising or bluish skin in||
2709|144|P|the fingers/toes.||
2709|145|P|   Before using this medication, women of childbearing age should||
2709|146|P|talk with their doctor(s) about the benefits and risks. Tell your||
2709|147|P|doctor if you are pregnant or if you plan to become pregnant.||
2709|148|P|This medication may harm an unborn baby and cause problems with||
2709|149|P|normal labor/delivery. It is not recommended for use in pregnancy||
2709|150|P|from 20 weeks until delivery. If your doctor decides that you||
2709|151|P|need to use this medication between 20 and 30 weeks of pregnancy,||
2709|152|P|you should use the lowest effective dose for the shortest||
2709|153|P|possible time. You should not use this medication after 30 weeks||
2709|154|P|of pregnancy.||
2709|155|P|   This medication passes into breast milk. Consult your doctor||
2709|156|P|before breastfeeding.||
2709|157|B|||
2709|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2709|159|I|medications work or increase your risk for serious side effects.||
2709|160|I|This document does not contain all possible drug interactions.||
2709|161|I|Keep a list of all the products you use (including||
2709|162|I|prescription/nonprescription drugs and herbal products) and share||
2709|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
2709|164|I|the dosage of any medicines without your doctor's approval.||
2709|165|I|   Some products that may interact with this drug are: aliskiren,||
2709|166|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
2709|167|I|receptor blockers (such as valsartan, losartan), cidofovir,||
2709|168|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
2709|169|I|methotrexate, "water pills" (diuretics such as furosemide).||
2709|170|I|   This medication may increase the risk of bleeding when taken||
2709|171|I|with other drugs that also may cause bleeding. Examples include||
2709|172|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
2709|173|I|dabigatran/enoxaparin/warfarin, among others.||
2709|174|I|   Check all prescription and nonprescription medicine labels||
2709|175|I|carefully since many medications contain pain relievers/fever||
2709|176|I|reducers (aspirin, NSAIDs such as naproxen, ibuprofen,||
2709|177|I|ketorolac). These drugs are similar to celecoxib and may increase||
2709|178|I|your risk of side effects if taken together. However, if your||
2709|179|I|doctor has told you to take low-dose aspirin to prevent heart||
2709|180|I|attack or stroke (usually 81-162 milligrams a day), you should||
2709|181|I|keep taking the aspirin unless your doctor tells you not to. Ask||
2709|182|I|your doctor or pharmacist for more details.||
2709|183|B|||
2709|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2709|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2709|186|O|poison control center right away. US residents can call||
2709|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2709|188|O|Symptoms of overdose may include: severe stomach pain,||
2709|189|O|slow/shallow breathing, or loss of consciousness.||
2709|190|B|||
2709|191|N|NOTES:  Do not share this medication with others.||
2709|192|N|   Lab and/or medical tests (such as blood pressure, complete||
2709|193|N|blood count, liver/kidney function) may be done while you are||
2709|194|N|using this medication. Keep all medical and lab appointments.||
2709|195|N|Consult your doctor for more details.||
2709|196|N|   Lifestyle changes (such as weight loss if needed,||
2709|197|N|strengthening/conditioning exercises) may help improve your||
2709|198|N|flexibility and joint function. Consult your doctor for specific||
2709|199|N|instructions.||
2709|200|B|||
2709|201|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2709|202|D|remember. If it is near the time of the next dose, skip the||
2709|203|D|missed dose. Take your next dose at the regular time. Do not||
2709|204|D|double the dose to catch up.||
2709|205|B|||
2709|206|R|STORAGE:  Store at room temperature away from light. Once the||
2709|207|R|bottle is opened, this medication expires after 21 days. Keep all||
2709|208|R|medications away from children and pets.||
2709|209|R|   Do not flush medications down the toilet or pour them into a||
2709|210|R|drain unless instructed to do so. Properly discard this product||
2709|211|R|when it is expired or no longer needed. Consult your pharmacist||
2709|212|R|or local waste disposal company.||
2709|213|B|||
2709|214|A|Information last revised October 2025.||
2709|215|A|Copyright(c) 2025 First Databank, Inc.||
2709|216|B|||
2710|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2710|002|Z|does NOT have all possible information about this product. This||
2710|003|Z|information does not assure that this product is safe, effective,||
2710|004|Z|or appropriate for you. This information is not individual||
2710|005|Z|medical advice and does not substitute for the advice of your||
2710|006|Z|health care professional. Always ask your health care||
2710|007|Z|professional for complete information about this product and your||
2710|008|Z|specific health needs.||
2710|009|B|||
2710|010|T|MACITENTAN DISPERSIBLE TABLET - ORAL||
2710|011|F|(MA-si-TEN-tan)||
2710|012|B|||
2710|013|W|WARNING:  Macitentan must not be used during pregnancy. It may||
2710|014|W|harm an unborn baby. It is important to prevent pregnancy while||
2710|015|W|taking this medication and for 1 month after treatment. Female||
2710|016|W|patients must use reliable birth control before starting||
2710|017|W|treatment, during treatment, and for 1 month after the last dose.||
2710|018|W|Ask your doctor which forms of birth control to use while taking||
2710|019|W|this medication. Female patients must take a pregnancy test||
2710|020|W|before starting treatment. If you become pregnant or think you||
2710|021|W|may be pregnant, tell your doctor right away.||
2710|022|B|||
2710|023|U|USES:  Macitentan is used to treat high blood pressure in the||
2710|024|U|lungs (pulmonary arterial hypertension). This condition is||
2710|025|U|thought to be caused by increased levels of a certain natural||
2710|026|U|substance (endothelin-1). This medication blocks the effects of||
2710|027|U|endothelin-1, which helps decrease the blood pressure in the||
2710|028|U|lungs, and reduces the risk of worsening of symptoms and hospital||
2710|029|U|stays due to the disease.||
2710|030|B|||
2710|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2710|032|H|from your pharmacist before you start taking macitentan and each||
2710|033|H|time you get a refill. If you have any questions, ask your doctor||
2710|034|H|or pharmacist.||
2710|035|H|   Take this medication by mouth with or without food as directed||
2710|036|H|by your doctor, usually once daily.||
2710|037|H|   Do not swallow the tablet(s) whole. This medication must be||
2710|038|H|mixed with a room temperature liquid (water, orange juice, apple||
2710|039|H|juice, skim milk) before taking. You may use a spoon or a cup to||
2710|040|H|mix the medication. If you are using a spoon, add some liquid to||
2710|041|H|the spoon and place the tablet(s) in the liquid. Stir gently||
2710|042|H|until the tablet(s) dissolves completely. You may drink the||
2710|043|H|mixture right away or you may add it to a small amount of apple||
2710|044|H|sauce or yogurt and eat the mixture right away. Add more liquid,||
2710|045|H|apple sauce, or yogurt to the spoon and take all of the mixture||
2710|046|H|to make sure you are getting all the medication. Do not prepare a||
2710|047|H|supply ahead of time.||
2710|048|H|   If you are using a cup, place the tablet(s) in the cup with||
2710|049|H|some room temperature water and stir gently until the tablet(s)||
2710|050|H|dissolves completely. Drink all of the mixture right away. Add||
2710|051|H|more water to the cup and drink all of the mixture to make sure||
2710|052|H|you are getting all the medication. Do not prepare a supply ahead||
2710|053|H|of time.||
2710|054|H|   The dosage is based on your medical condition and response to||
2710|055|H|treatment. Children's dosage is also based on weight.||
2710|056|H|   Use this medication regularly to get the most benefit from it.||
2710|057|H|To help you remember, take it at the same time each day.||
2710|058|H|   Do not increase your dose or use this drug more often or for||
2710|059|H|longer than prescribed. Your condition will not improve any||
2710|060|H|faster, and your risk of side effects will increase.||
2710|061|H|   Since this drug can be absorbed through the skin and lungs and||
2710|062|H|may harm an unborn baby, women who are pregnant or who may become||
2710|063|H|pregnant should not handle this medication or breathe the dust||
2710|064|H|from the tablets.||
2710|065|H|   Tell your doctor if your condition does not get better or if||
2710|066|H|it gets worse.||
2710|067|B|||
2710|068|S|SIDE EFFECTS:  Runny nose, sore throat, cough, headache, chills,||
2710|069|S|or body aches may occur. If any of these effects last or get||
2710|070|S|worse, tell your doctor or pharmacist promptly.||
2710|071|S|   Remember that this medication has been prescribed because your||
2710|072|S|doctor has judged that the benefit to you is greater than the||
2710|073|S|risk of side effects. Many people using this medication do not||
2710|074|S|have serious side effects.||
2710|075|S|   Tell your doctor right away if you have any serious side||
2710|076|S|effects, including: signs of low red blood cell count (such as||
2710|077|S|unusual tiredness, rapid breathing, pale skin, shortness of||
2710|078|S|breath, fast heartbeat), unusual weight gain, new or worsening||
2710|079|S|swelling of the hands/ankles/feet.||
2710|080|S|   Macitentan may rarely cause serious liver disease. Tell your||
2710|081|S|doctor right away if you have any symptoms of liver disease,||
2710|082|S|including: nausea/vomiting that doesn't stop, loss of appetite,||
2710|083|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
2710|084|S|   A very serious allergic reaction to this drug is rare.||
2710|085|S|However, get medical help right away if you notice any symptoms||
2710|086|S|of a serious allergic reaction, including: rash, itching/swelling||
2710|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2710|088|S|breathing.||
2710|089|S|   This is not a complete list of possible side effects. If you||
2710|090|S|notice other effects not listed above, contact your doctor or||
2710|091|S|pharmacist.||
2710|092|S|   In the US -||
2710|093|S|   Call your doctor for medical advice about side effects. You||
2710|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2710|095|S|www.fda.gov/medwatch.||
2710|096|S|   In Canada - Call your doctor for medical advice about side||
2710|097|S|effects. You may report side effects to Health Canada at||
2710|098|S|1-866-234-2345.||
2710|099|B|||
2710|100|P|PRECAUTIONS:  Before taking macitentan, tell your doctor or||
2710|101|P|pharmacist if you are allergic to it; or if you have any other||
2710|102|P|allergies. This product may contain inactive ingredients, which||
2710|103|P|can cause allergic reactions or other problems. Talk to your||
2710|104|P|pharmacist for more details.||
2710|105|P|   Before using this medication, tell your doctor or pharmacist||
2710|106|P|your medical history, especially of: anemia, liver disease, other||
2710|107|P|lung conditions (such as pulmonary veno-occlusive disease).||
2710|108|P|   Before having surgery, tell your doctor or dentist about all||
2710|109|P|the products you use (including prescription drugs,||
2710|110|P|nonprescription drugs, and herbal products).||
2710|111|P|   This medication can affect fertility in males. Ask your doctor||
2710|112|P|for more details.||
2710|113|P|   Since this drug can be absorbed through the skin and lungs and||
2710|114|P|may harm an unborn baby, women who are pregnant or who may become||
2710|115|P|pregnant should not handle this medication or breathe the dust||
2710|116|P|from the tablets.||
2710|117|P|   This medication must not be used during pregnancy. It may harm||
2710|118|P|an unborn baby. Discuss the use of reliable forms of birth||
2710|119|P|control (such as condoms, birth control pills) before starting||
2710|120|P|treatment, during treatment, and for 1 month after the last dose.||
2710|121|P|If you become pregnant or think you may be pregnant, tell your||
2710|122|P|doctor right away. See also Warning section.||
2710|123|P|   It is unknown if this medication passes into breast milk.||
2710|124|P|Because of the possible risk to the infant, breastfeeding is not||
2710|125|P|recommended while using this medication. Consult your doctor||
2710|126|P|before breastfeeding.||
2710|127|B|||
2710|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2710|129|I|medications work or increase your risk for serious side effects.||
2710|130|I|This document does not contain all possible drug interactions.||
2710|131|I|Keep a list of all the products you use (including||
2710|132|I|prescription/nonprescription drugs and herbal products) and share||
2710|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
2710|134|I|the dosage of any medicines without your doctor's approval.||
2710|135|I|   A product that may interact with this drug is: sparsentan.||
2710|136|I|   Other medications can affect the removal of macitentan from||
2710|137|I|your body, which may affect how macitentan works. Examples||
2710|138|I|include amiodarone, azole antifungals (such as fluconazole,||
2710|139|I|ketoconazole), cobicistat, macrolide antibiotics (such as||
2710|140|I|clarithromycin), rifamycins (such as rifampin), ritonavir, among||
2710|141|I|others.||
2710|142|B|||
2710|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2710|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2710|145|O|poison control center right away. US residents can call||
2710|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2710|147|B|||
2710|148|N|NOTES:  Do not share this medication with others.||
2710|149|N|   Lab tests (such as liver function, hemoglobin) should be done||
2710|150|N|before you start taking this medication and while you are taking||
2710|151|N|it. Keep all medical and lab appointments. Consult your doctor||
2710|152|N|for more details.||
2710|153|B|||
2710|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
2710|155|D|remember. If it is near the time of the next dose, skip the||
2710|156|D|missed dose. Take your next dose at the regular time. Do not||
2710|157|D|double the dose to catch up.||
2710|158|B|||
2710|159|R|STORAGE:  Store at room temperature away from light and moisture.||
2710|160|R|Keep the medication in the original packaging until ready to use.||
2710|161|R|Do not store in the bathroom. Keep all medications away from||
2710|162|R|children and pets.||
2710|163|R|   Do not flush medications down the toilet or pour them into a||
2710|164|R|drain unless instructed to do so. Properly discard this product||
2710|165|R|when it is expired or no longer needed. Consult your pharmacist||
2710|166|R|or local waste disposal company.||
2710|167|B|||
2710|168|A|Information last revised November 2025.||
2710|169|A|Copyright(c) 2025 First Databank, Inc.||
2710|170|B|||
2711|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2711|002|Z|does NOT have all possible information about this product. This||
2711|003|Z|information does not assure that this product is safe, effective,||
2711|004|Z|or appropriate for you. This information is not individual||
2711|005|Z|medical advice and does not substitute for the advice of your||
2711|006|Z|health care professional. Always ask your health care||
2711|007|Z|professional for complete information about this product and your||
2711|008|Z|specific health needs.||
2711|009|B|||
2711|010|T|CYCLOBENZAPRINE - SUBLINGUAL||
2711|011|F|(SYE-kloe-BEN-za-preen)||
2711|012|B|||
2711|013|C|COMMON BRAND NAME(S): Tonmya||
2711|014|B|||
2711|015|U|USES:  Cyclobenzaprine is used to treat pain caused by a||
2711|016|U|condition called fibromyalgia that affects the muscles, tendons,||
2711|017|U|ligaments, and supporting tissues. It works by helping to relax||
2711|018|U|the muscles.||
2711|019|B|||
2711|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2711|021|H|from your pharmacist before you start taking cyclobenzaprine and||
2711|022|H|each time you get a refill. If you have any questions, ask your||
2711|023|H|doctor or pharmacist.||
2711|024|H|   Take this medication by mouth without food as directed by your||
2711|025|H|doctor, usually once daily at bedtime. The dosage is based on||
2711|026|H|your medical condition and response to treatment.||
2711|027|H|   Dry your hands before handling the medication. After brushing||
2711|028|H|your teeth, drink a few sips of water before taking this||
2711|029|H|medication. Place the tablet (s) under the tongue, allow it to||
2711|030|H|dissolve completely and then swallow it with saliva. You do not||
2711|031|H|need to take this medication with water. Do not swallow whole,||
2711|032|H|cut, crush, or chew the tablet. Avoid eating or drinking for at||
2711|033|H|least 15 minutes after taking this medication. Avoid hot, cold,||
2711|034|H|or acidic beverages until the next morning. Avoid talking for at||
2711|035|H|least 5 minutes.||
2711|036|H|   To reduce your risk of side effects, your doctor may direct||
2711|037|H|you to start this medication at a low dose and gradually increase||
2711|038|H|your dose. Follow your doctor's instructions carefully.||
2711|039|H|   Use this medication regularly to get the most benefit from it.||
2711|040|H|To help you remember, take it at the same time each day.||
2711|041|H|   Do not increase your dose or use this drug more often or for||
2711|042|H|longer than prescribed. Your condition will not improve any||
2711|043|H|faster, and your risk of side effects will increase.||
2711|044|H|   Tell your doctor if your condition does not get better or if||
2711|045|H|it gets worse.||
2711|046|B|||
2711|047|S|SIDE EFFECTS:  Drowsiness, dizziness, dry mouth, constipation, or||
2711|048|S|tiredness may occur. Numbness, tingling, pain, or swelling in the||
2711|049|S|mouth may also occur after taking this medication. Drink a few||
2711|050|S|sips of water before taking cyclobenzaprine to reduce these side||
2711|051|S|effects in the mouth. If any of these effects last or get worse,||
2711|052|S|tell your doctor or pharmacist promptly.||
2711|053|S|   Remember that this medication has been prescribed because your||
2711|054|S|doctor has judged that the benefit to you is greater than the||
2711|055|S|risk of side effects. Many people using this medication do not||
2711|056|S|have serious side effects.||
2711|057|S|   Tell your doctor right away if you have any serious side||
2711|058|S|effects, including: fast/irregular heartbeat, mental/mood changes||
2711|059|S|(such as confusion, hallucinations).||
2711|060|S|   A very serious allergic reaction to this drug is rare.||
2711|061|S|However, get medical help right away if you notice any symptoms||
2711|062|S|of a serious allergic reaction, including: rash, itching/swelling||
2711|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2711|064|S|breathing.||
2711|065|S|   This is not a complete list of possible side effects. If you||
2711|066|S|notice other effects not listed above, contact your doctor or||
2711|067|S|pharmacist.||
2711|068|S|   In the US -||
2711|069|S|   Call your doctor for medical advice about side effects. You||
2711|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2711|071|S|www.fda.gov/medwatch.||
2711|072|S|   In Canada - Call your doctor for medical advice about side||
2711|073|S|effects. You may report side effects to Health Canada at||
2711|074|S|1-866-234-2345.||
2711|075|B|||
2711|076|P|PRECAUTIONS:  Before taking cyclobenzaprine, tell your doctor or||
2711|077|P|pharmacist if you are allergic to it; or if you have any other||
2711|078|P|allergies. This product may contain inactive ingredients, which||
2711|079|P|can cause allergic reactions or other problems. Talk to your||
2711|080|P|pharmacist for more details.||
2711|081|P|   Before using this medication, tell your doctor or pharmacist||
2711|082|P|your medical history, especially of: liver disease, overactive||
2711|083|P|thyroid (hyperthyroidism), heart problems (such as irregular||
2711|084|P|heartbeat, heart block, heart failure, recent heart attack),||
2711|085|P|difficulty urinating (such as due to an enlarged prostate),||
2711|086|P|glaucoma.||
2711|087|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2711|088|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2711|089|P|machinery, or do anything that needs alertness until you can do||
2711|090|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
2711|091|P|are using marijuana (cannabis).||
2711|092|P|   Before having surgery, tell your doctor or dentist about all||
2711|093|P|the products you use (including prescription drugs,||
2711|094|P|nonprescription drugs, and herbal products).||
2711|095|P|   Older adults may be more sensitive to the side effects of this||
2711|096|P|drug, especially drowsiness, confusion, constipation, or trouble||
2711|097|P|urinating. Drowsiness and confusion can increase the risk of||
2711|098|P|falling.||
2711|099|P|   During pregnancy, this medication should be used only when||
2711|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
2711|101|P|   This medication passes into breast milk. Consult your doctor||
2711|102|P|before breastfeeding.||
2711|103|B|||
2711|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2711|105|I|medications work or increase your risk for serious side effects.||
2711|106|I|This document does not contain all possible drug interactions.||
2711|107|I|Keep a list of all the products you use (including||
2711|108|I|prescription/nonprescription drugs and herbal products) and share||
2711|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
2711|110|I|the dosage of any medicines without your doctor's approval.||
2711|111|I|   Some products that may interact with this drug are: tricyclic||
2711|112|I|antidepressants (such as amitriptyline, imipramine).||
2711|113|I|   Taking MAO inhibitors with this medication may cause a serious||
2711|114|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
2711|115|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
2711|116|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
2711|117|I|selegiline, tranylcypromine) during treatment with this||
2711|118|I|medication. Most MAO inhibitors should also not be taken for two||
2711|119|I|weeks before treatment with this medication. Ask your doctor when||
2711|120|I|to start or stop taking this medication.||
2711|121|I|   Before using this medication, report the use of drugs that||
2711|122|I|increase serotonin, including street drugs (such as||
2711|123|I|MDMA/"ecstasy"), St. John's wort, certain antidepressants||
2711|124|I|(including SSRIs such as fluoxetine/paroxetine, SNRIs such as||
2711|125|I|duloxetine/venlafaxine), tramadol, among others.||
2711|126|I|   Tell your doctor or pharmacist if you are taking other||
2711|127|I|products that cause drowsiness such as opioid pain or cough||
2711|128|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
2711|129|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
2711|130|I|lorazepam, zolpidem), other muscle relaxants (such as||
2711|131|I|carisoprodol, methocarbamol), or antihistamines (such as||
2711|132|I|cetirizine, diphenhydramine).||
2711|133|I|   Check the labels on all your medicines (such as allergy or||
2711|134|I|cough-and-cold products) because they may contain ingredients||
2711|135|I|that cause drowsiness. Ask your pharmacist about using those||
2711|136|I|products safely.||
2711|137|B|||
2711|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2711|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2711|140|O|poison control center right away. US residents can call||
2711|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2711|142|O|Symptoms of overdose may include: fast/irregular heartbeat,||
2711|143|O|fainting, severe drowsiness, trouble speaking, seizures,||
2711|144|O|mental/mood changes (such as confusion, hallucinations).||
2711|145|B|||
2711|146|N|NOTES:  Do not share this medication with others.||
2711|147|B|||
2711|148|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2711|149|D|next dose at the regular time. Do not double the dose to catch||
2711|150|D|up.||
2711|151|B|||
2711|152|R|STORAGE:  Store in the original container at room temperature||
2711|153|R|away from light and moisture. Do not store in the bathroom. Keep||
2711|154|R|the drying agent (desiccant) in the container. Keep all||
2711|155|R|medications away from children and pets.||
2711|156|R|   Do not flush medications down the toilet or pour them into a||
2711|157|R|drain unless instructed to do so. Properly discard this product||
2711|158|R|when it is expired or no longer needed. Consult your pharmacist||
2711|159|R|or local waste disposal company.||
2711|160|B|||
2711|161|A|Information last revised November 2025.||
2711|162|A|Copyright(c) 2025 First Databank, Inc.||
2711|163|B|||
2712|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
2712|002|Z|does NOT have all possible information about this product. This||
2712|003|Z|information does not assure that this product is safe, effective,||
2712|004|Z|or appropriate for you. This information is not individual||
2712|005|Z|medical advice and does not substitute for the advice of your||
2712|006|Z|health care professional. Always ask your health care||
2712|007|Z|professional for complete information about this product and your||
2712|008|Z|specific health needs.||
2712|009|B|||
2712|010|T|ELINZANETANT - ORAL||
2712|011|B|||
2712|012|C|COMMON BRAND NAME(S): Lynkuet||
2712|013|B|||
2712|014|U|USES:  This medication is used to help reduce hot flashes due to||
2712|015|U|menopause. Elinzanetant works by blocking certain proteins in the||
2712|016|U|temperature control area of the brain that can lead to hot||
2712|017|U|flashes.||
2712|018|B|||
2712|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
2712|020|H|from your pharmacist before you start taking elinzanetant and||
2712|021|H|each time you get a refill. If you have any questions, ask your||
2712|022|H|doctor or pharmacist.||
2712|023|H|   Take this medication by mouth with or without food as directed||
2712|024|H|by your doctor, usually once daily at bedtime. Swallow the||
2712|025|H|capsules whole with water. Do not cut, crush, or chew the||
2712|026|H|capsules.||
2712|027|H|   The dosage is based on your medical condition, response to||
2712|028|H|treatment, and other medications you may be taking. Be sure to||
2712|029|H|tell your doctor and pharmacist about all the products you use||
2712|030|H|(including prescription drugs, nonprescription drugs, and herbal||
2712|031|H|products).||
2712|032|H|   Use this medication regularly to get the most benefit from it.||
2712|033|H|To help you remember, take it at the same time each day.||
2712|034|H|   Do not increase your dose or use this drug more often or for||
2712|035|H|longer than prescribed. Your condition will not improve any||
2712|036|H|faster, and your risk of side effects will increase.||
2712|037|H|   Avoid eating grapefruit or drinking grapefruit juice while||
2712|038|H|using this medication unless your doctor or pharmacist says you||
2712|039|H|may do so safely. Grapefruit can increase the chance of side||
2712|040|H|effects with this medicine. Ask your doctor or pharmacist for||
2712|041|H|more details.||
2712|042|H|   Tell your doctor if your condition does not get better or if||
2712|043|H|it gets worse.||
2712|044|B|||
2712|045|S|SIDE EFFECTS:  Headache, tiredness, feeling of spinning,||
2712|046|S|dizziness, or drowsiness may occur. Drowsiness may also occur||
2712|047|S|during the daytime. Do not drive, use machinery, or do anything||
2712|048|S|that needs alertness until you can do it safely (see also||
2712|049|S|Precautions section). If any of these effects last or get worse,||
2712|050|S|tell your doctor or pharmacist promptly.||
2712|051|S|   Remember that this medication has been prescribed because your||
2712|052|S|doctor has judged that the benefit to you is greater than the||
2712|053|S|risk of side effects. Many people using this medication do not||
2712|054|S|have serious side effects.||
2712|055|S|   Tell your doctor right away if you have any serious side||
2712|056|S|effects, including: signs of liver disease (such as||
2712|057|S|nausea/vomiting that doesn't stop, loss of appetite,||
2712|058|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
2712|059|S|   Get medical help right away if you have any very serious side||
2712|060|S|effects, including: fainting, seizures.||
2712|061|S|   A very serious allergic reaction to this drug is rare.||
2712|062|S|However, get medical help right away if you notice any symptoms||
2712|063|S|of a serious allergic reaction, including: rash, itching/swelling||
2712|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
2712|065|S|breathing.||
2712|066|S|   This is not a complete list of possible side effects. If you||
2712|067|S|notice other effects not listed above, contact your doctor or||
2712|068|S|pharmacist.||
2712|069|S|   In the US -||
2712|070|S|   Call your doctor for medical advice about side effects. You||
2712|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
2712|072|S|www.fda.gov/medwatch.||
2712|073|S|   In Canada - Call your doctor for medical advice about side||
2712|074|S|effects. You may report side effects to Health Canada at||
2712|075|S|1-866-234-2345.||
2712|076|B|||
2712|077|P|PRECAUTIONS:  Before taking elinzanetant, tell your doctor or||
2712|078|P|pharmacist if you are allergic to it; or if you have any other||
2712|079|P|allergies. This product may contain inactive ingredients, which||
2712|080|P|can cause allergic reactions or other problems. Talk to your||
2712|081|P|pharmacist for more details.||
2712|082|P|   Before using this medication, tell your doctor or pharmacist||
2712|083|P|your medical history, especially of: liver disease, seizures.||
2712|084|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
2712|085|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
2712|086|P|machinery, or do anything that needs alertness until you can do||
2712|087|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
2712|088|P|are using marijuana (cannabis).||
2712|089|P|   Before having surgery, tell your doctor or dentist about all||
2712|090|P|the products you use (including prescription drugs,||
2712|091|P|nonprescription drugs, and herbal products).||
2712|092|P|   This medication is not usually used by women of childbearing||
2712|093|P|age. It is unlikely to be used during pregnancy or breastfeeding.||
2712|094|P|Consult your doctor if you have any questions about this||
2712|095|P|medication.||
2712|096|B|||
2712|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
2712|098|I|medications work or increase your risk for serious side effects.||
2712|099|I|This document does not contain all possible drug interactions.||
2712|100|I|Keep a list of all the products you use (including||
2712|101|I|prescription/nonprescription drugs and herbal products) and share||
2712|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
2712|103|I|the dosage of any medicines without your doctor's approval.||
2712|104|I|   Other medications can affect the removal of elinzanetant from||
2712|105|I|your body, which may affect how elinzanetant works. Examples||
2712|106|I|include carbamazepine, itraconazole, among others.||
2712|107|B|||
2712|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
2712|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
2712|110|O|poison control center right away. US residents can call||
2712|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
2712|112|B|||
2712|113|N|NOTES:  Do not share this medication with others.||
2712|114|N|   Lab and/or medical tests (such as liver function) should be||
2712|115|N|done before you start taking this medication and while you are||
2712|116|N|taking it. Keep all medical and lab appointments. Consult your||
2712|117|N|doctor for more details.||
2712|118|N|   Lifestyle changes that may help reduce hot flashes include||
2712|119|N|stopping smoking, dressing lightly or in layers,||
2712|120|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
2712|121|N|reducing stress, and exercising regularly.||
2712|122|B|||
2712|123|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
2712|124|D|next dose at the regular time the next day. Do not double the||
2712|125|D|dose to catch up.||
2712|126|B|||
2712|127|R|STORAGE:  Store at room temperature away from light and moisture.||
2712|128|R|Do not store in the bathroom. Keep all medications away from||
2712|129|R|children and pets.||
2712|130|R|   Do not flush medications down the toilet or pour them into a||
2712|131|R|drain unless instructed to do so. Properly discard this product||
2712|132|R|when it is expired or no longer needed. Consult your pharmacist||
2712|133|R|or local waste disposal company.||
2712|134|B|||
2712|135|A|Information last revised November 2025.||
2712|136|A|Copyright(c) 2025 First Databank, Inc.||
2712|137|B|||
3003|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3003|002|Z|does NOT have all possible information about this product. This||
3003|003|Z|information does not assure that this product is safe, effective,||
3003|004|Z|or appropriate for you. This information is not individual||
3003|005|Z|medical advice and does not substitute for the advice of your||
3003|006|Z|health care professional. Always ask your health care||
3003|007|Z|professional for complete information about this product and your||
3003|008|Z|specific health needs.||
3003|009|B|||
3003|010|T|ASPIRIN CHEWABLE - ORAL||
3003|011|F|(AS-pir-in)||
3003|012|B|||
3003|013|C|COMMON BRAND NAME(S): Children's Aspirin||
3003|014|B|||
3003|015|U|USES:  Aspirin is used to reduce fever and relieve mild to||
3003|016|U|moderate pain from conditions such as muscle aches, toothaches,||
3003|017|U|common cold, and headaches. It may also be used to reduce pain||
3003|018|U|and swelling in conditions such as arthritis. Aspirin is known as||
3003|019|U|a salicylate and a nonsteroidal anti-inflammatory drug (NSAID).||
3003|020|U|It works by blocking a certain natural substance in your body to||
3003|021|U|reduce pain and swelling. Consult your doctor before giving this||
3003|022|U|drug to a child younger than 12 years. It is very important to||
3003|023|U|keep this and all medication out of the reach of children.||
3003|024|U|Aspirin is a common cause of poisoning in children. (See also||
3003|025|U|Overdose section.)||
3003|026|U|   Your doctor may direct you to take a low dose of aspirin to||
3003|027|U|prevent blood clots. This effect reduces the risk of stroke and||
3003|028|U|heart attack. If you have recently had surgery on clogged||
3003|029|U|arteries (such as bypass surgery, carotid endarterectomy,||
3003|030|U|coronary stent), your doctor may direct you to use aspirin in low||
3003|031|U|doses as a "blood thinner" to prevent blood clots. Aspirin||
3003|032|U|prevents blood clots by stopping certain blood cells (platelets)||
3003|033|U|from clumping together.||
3003|034|B|||
3003|035|H|HOW TO USE:  If you are taking this medication for||
3003|036|H|self-treatment, follow all directions on the product package. If||
3003|037|H|you have any questions, ask your doctor or pharmacist. If your||
3003|038|H|doctor has directed you to take this medication, take it exactly||
3003|039|H|as prescribed.||
3003|040|H|   Chew the tablet thoroughly before swallowing. This medication||
3003|041|H|may also be crushed or swallowed whole. If stomach upset occurs||
3003|042|H|while you are taking this medication, you may take it with food||
3003|043|H|or milk.||
3003|044|H|   The dosage and length of treatment are based on your medical||
3003|045|H|condition and response to treatment. Read the product label to||
3003|046|H|find recommendations on how many tablets you can take in a||
3003|047|H|24-hour period and how long you may self-treat before seeking||
3003|048|H|medical advice. Do not take more medication or take it for longer||
3003|049|H|than recommended unless directed by your doctor. Use the smallest||
3003|050|H|effective dose. Consult your doctor or pharmacist if you have any||
3003|051|H|questions.||
3003|052|H|   If you are taking this medication for self-treatment of||
3003|053|H|headache, get medical help right away if you also have trouble||
3003|054|H|speaking, weakness on one side of the body, or sudden vision||
3003|055|H|changes. Before using this drug, consult a doctor or pharmacist||
3003|056|H|if you have headaches caused by head injury, coughing, or||
3003|057|H|bending, or if you have a headache with vomiting that is severe||
3003|058|H|or doesn't stop, fever, and stiff neck. These may be signs of||
3003|059|H|serious medical conditions.||
3003|060|H|   If you are taking this medication as needed (not on a regular||
3003|061|H|schedule), remember that pain medications work best if they are||
3003|062|H|used as the first signs of pain occur. If you wait until the pain||
3003|063|H|has worsened, the medicine may not work as well.||
3003|064|H|   You should not take this medication for self-treatment of pain||
3003|065|H|for longer than 10 days. You should not use this drug to||
3003|066|H|self-treat a fever that lasts longer than 3 days. In these cases,||
3003|067|H|consult a doctor because you may have a more serious condition.||
3003|068|H|Tell your doctor promptly if you develop ringing in the ears or||
3003|069|H|difficulty hearing.||
3003|070|H|   If your condition lasts or gets worse (such as new or unusual||
3003|071|H|symptoms, redness/swelling of the painful area, pain/fever that||
3003|072|H|does not go away or gets worse) or if you think you may have a||
3003|073|H|serious medical problem, tell your doctor promptly.||
3003|074|B|||
3003|075|S|SIDE EFFECTS:  Upset stomach and heartburn may occur. If either||
3003|076|S|of these effects lasts or gets worse, tell your doctor or||
3003|077|S|pharmacist promptly.||
3003|078|S|   If your doctor has directed you to use this medication,||
3003|079|S|remember that your doctor has judged that the benefit to you is||
3003|080|S|greater than the risk of side effects. Many people using this||
3003|081|S|medication do not have serious side effects.||
3003|082|S|   Tell your doctor right away if you have any serious side||
3003|083|S|effects, including: nausea/vomiting that is severe or doesn't||
3003|084|S|stop, easy bruising/bleeding, difficulty hearing, ringing ears,||
3003|085|S|signs of kidney problems (such as change in the amount of urine),||
3003|086|S|unexplained tiredness, dizziness, dark urine, yellowing||
3003|087|S|eyes/skin.||
3003|088|S|   This drug may rarely cause serious bleeding from the||
3003|089|S|stomach/intestine or other areas of the body. If you notice any||
3003|090|S|of the following very serious side effects, get medical help||
3003|091|S|right away: stomach/abdominal pain that is severe or doesn't go||
3003|092|S|away, black/tarry stools, vomit that looks like coffee grounds,||
3003|093|S|trouble speaking, weakness on one side of the body, sudden vision||
3003|094|S|changes, sudden severe headache.||
3003|095|S|   A very serious allergic reaction to this drug is rare.||
3003|096|S|However, get medical help right away if you notice any symptoms||
3003|097|S|of a serious allergic reaction, including: fever, swollen lymph||
3003|098|S|nodes, rash, itching/swelling (especially of the||
3003|099|S|face/tongue/throat), severe dizziness, trouble breathing.||
3003|100|S|   This is not a complete list of possible side effects. If you||
3003|101|S|notice other effects not listed above, contact your doctor or||
3003|102|S|pharmacist.||
3003|103|S|   In the US -||
3003|104|S|   Call your doctor for medical advice about side effects. You||
3003|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3003|106|S|www.fda.gov/medwatch.||
3003|107|S|   In Canada - Call your doctor for medical advice about side||
3003|108|S|effects. You may report side effects to Health Canada at||
3003|109|S|1-866-234-2345.||
3003|110|B|||
3003|111|P|PRECAUTIONS:  Before taking aspirin, tell your doctor or||
3003|112|P|pharmacist if you are allergic to it; or to other salicylates||
3003|113|P|(such as choline salicylate); or to other pain relievers or fever||
3003|114|P|reducers (other NSAIDs such as ibuprofen, naproxen); or if you||
3003|115|P|have any other allergies. This product may contain inactive||
3003|116|P|ingredients, which can cause allergic reactions or other||
3003|117|P|problems. Talk to your pharmacist for more details.||
3003|118|P|   If you have any of the following health problems, consult your||
3003|119|P|doctor or pharmacist before using this medication:||
3003|120|P|bleeding/blood-clotting disorders (such as hemophilia, vitamin K||
3003|121|P|deficiency, low platelet count), kidney disease, liver disease,||
3003|122|P|stomach problems (such as ulcers, heartburn, stomach pain),||
3003|123|P|asthma (including a history of worsening breathing after taking||
3003|124|P|aspirin or other NSAIDs), growths in the nose (nasal polyps),||
3003|125|P|gout, certain enzyme deficiencies (pyruvate kinase or G6PD||
3003|126|P|deficiency).||
3003|127|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
3003|128|P|and tobacco, especially when combined with this product, may||
3003|129|P|increase your risk for this side effect. Limit alcoholic||
3003|130|P|beverages, and stop smoking. Check with your doctor or pharmacist||
3003|131|P|for more information.||
3003|132|P|   Before having surgery, tell your doctor or dentist about all||
3003|133|P|the products you use (including prescription drugs,||
3003|134|P|nonprescription drugs, and herbal products).||
3003|135|P|   Children and teenagers less than 18 years old should not take||
3003|136|P|aspirin if they have chickenpox, flu, or any undiagnosed illness||
3003|137|P|or if they have recently received a vaccine. In these cases,||
3003|138|P|taking aspirin increases the risk of Reye's syndrome, a rare but||
3003|139|P|serious illness. Tell your doctor promptly if you see changes in||
3003|140|P|behavior with nausea and vomiting. This may be an early sign of||
3003|141|P|Reye's syndrome.||
3003|142|P|   Older adults may be more sensitive to the side effects of this||
3003|143|P|drug, especially stomach/intestinal bleeding and ulcers.||
3003|144|P|   During pregnancy, this medication should be used only when||
3003|145|P|clearly needed. Aspirin is not recommended for use to treat pain||
3003|146|P|or fever during pregnancy. In some cases, low-dose aspirin||
3003|147|P|(usually 81-162 milligrams a day) may be used safely during||
3003|148|P|pregnancy to prevent certain conditions. Talk to your doctor for||
3003|149|P|more details..||
3003|150|P|   Aspirin passes into breast milk. When used in large amounts||
3003|151|P|(such as to treat pain or fever), it may harm a nursing infant||
3003|152|P|and breastfeeding is not recommended while using this medication.||
3003|153|P|However, low-dose aspirin for heart attack or stroke prevention||
3003|154|P|may be used if directed by your doctor. Consult your doctor||
3003|155|P|before breastfeeding.||
3003|156|B|||
3003|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3003|158|I|medications work or increase your risk for serious side effects.||
3003|159|I|This document does not contain all possible drug interactions.||
3003|160|I|Keep a list of all the products you use (including||
3003|161|I|prescription/nonprescription drugs and herbal products) and share||
3003|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
3003|163|I|the dosage of any medicines without your doctor's approval.||
3003|164|I|   Some products that may interact with this drug include:||
3003|165|I|acetazolamide, other "blood thinners" (such as warfarin,||
3003|166|I|heparin), corticosteroids (such as prednisone), dichlorphenamide,||
3003|167|I|herbal medications (such as ginkgo biloba), methotrexate,||
3003|168|I|mifepristone, valproic acid.||
3003|169|I|   Before using this product, consult your doctor if you have||
3003|170|I|recently received certain live vaccines (such as varicella||
3003|171|I|vaccine, live flu vaccine).||
3003|172|I|   Check all prescription and nonprescription medicine labels||
3003|173|I|carefully since many medications contain pain relievers/fever||
3003|174|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
3003|175|I|naproxen). These drugs are similar to this medication and may||
3003|176|I|increase your risk of side effects if taken together.||
3003|177|I|   Daily use of NSAIDs (such as ibuprofen) may decrease aspirin's||
3003|178|I|ability to prevent heart attack/stroke. If you are taking||
3003|179|I|low-dose aspirin for prevention of heart attack/stroke, consult||
3003|180|I|your doctor or pharmacist for more details and to discuss other||
3003|181|I|possible treatments (such as acetaminophen) for your pain/fever.||
3003|182|I|   This medication may interfere with certain lab tests (such as||
3003|183|I|certain urine sugar tests), possibly causing false test results.||
3003|184|I|Make sure lab personnel and all your doctors know you use this||
3003|185|I|drug.||
3003|186|B|||
3003|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3003|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3003|189|O|poison control center right away. US residents can call||
3003|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3003|191|O|Symptoms of overdose may include: burning pain in the||
3003|192|O|throat/stomach, confusion, mental/mood changes, fainting,||
3003|193|O|weakness, ringing in the ears, fever, rapid breathing, change in||
3003|194|O|the amount of urine, seizures, loss of consciousness.||
3003|195|B|||
3003|196|N|NOTES:  If you use this medication regularly or at high doses,||
3003|197|N|lab and/or medical tests (such as liver/kidney function, blood||
3003|198|N|count, salicylate level) may be done while you are taking this||
3003|199|N|medication. Keep all medical and lab appointments. Consult your||
3003|200|N|doctor for more details.||
3003|201|N|   There are many different aspirin products. Some have special||
3003|202|N|coatings and some are long-acting. Ask your doctor or pharmacist||
3003|203|N|to recommend the best product for you.||
3003|204|B|||
3003|205|D|MISSED DOSE:  If your doctor directs you to take this drug on a||
3003|206|D|regular schedule (not just "as needed") and you miss a dose, take||
3003|207|D|it as soon as you remember. If it is near the time of the next||
3003|208|D|dose, skip the missed dose. Take your next dose at the regular||
3003|209|D|time. Do not double the dose to catch up.||
3003|210|B|||
3003|211|R|STORAGE:  Store at room temperature away from moisture and light.||
3003|212|R|Different brands of this medication may have different storage||
3003|213|R|needs. Check the product package for instructions on how to store||
3003|214|R|your brand, or ask your pharmacist. Do not store in the bathroom.||
3003|215|R|Do not use any aspirin product that has a strong vinegar-like||
3003|216|R|smell. Keep all medications away from children and pets.||
3003|217|R|   Do not flush medications down the toilet or pour them into a||
3003|218|R|drain unless instructed to do so. Properly discard this product||
3003|219|R|when it is expired or no longer needed. Consult your pharmacist||
3003|220|R|or local waste disposal company.||
3003|221|B|||
3003|222|A|Information last revised November 2025.||
3003|223|A|Copyright(c) 2025 First Databank, Inc.||
3003|224|B|||
3005|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3005|002|Z|does NOT have all possible information about this product. This||
3005|003|Z|information does not assure that this product is safe, effective,||
3005|004|Z|or appropriate for you. This information is not individual||
3005|005|Z|medical advice and does not substitute for the advice of your||
3005|006|Z|health care professional. Always ask your health care||
3005|007|Z|professional for complete information about this product and your||
3005|008|Z|specific health needs.||
3005|009|B|||
3005|010|T|OXCARBAZEPINE SUSPENSION - ORAL||
3005|011|F|(ox-kar-BAY-zih-peen)||
3005|012|B|||
3005|013|C|COMMON BRAND NAME(S): Trileptal||
3005|014|B|||
3005|015|U|USES:  Oxcarbazepine is used alone or with other medications to||
3005|016|U|treat seizure disorders (epilepsy).||
3005|017|B|||
3005|018|V|OTHER USES:  This section contains uses of this drug that are not||
3005|019|V|listed in the approved professional labeling for the drug but||
3005|020|V|that may be prescribed by your health care professional. Use this||
3005|021|V|drug for a condition that is listed in this section only if it||
3005|022|V|has been so prescribed by your health care professional.||
3005|023|V|   This drug may also be used for certain types of nerve pain||
3005|024|V|(such as trigeminal neuralgia).||
3005|025|B|||
3005|026|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
3005|027|H|provided by your pharmacist before you start using oxcarbazepine||
3005|028|H|and each time you get a refill. If you have any questions, ask||
3005|029|H|your doctor or pharmacist.||
3005|030|H|   Shake the bottle well before each dose. Carefully measure the||
3005|031|H|dose using the oral measuring syringe provided. Do not use a||
3005|032|H|household spoon because you may not get the correct dose. The||
3005|033|H|medication may be swallowed directly from the oral syringe or||
3005|034|H|mixed in a small glass of water. Take this medication by mouth||
3005|035|H|with or without food as directed by your doctor, usually twice||
3005|036|H|daily.||
3005|037|H|   The dosage is based on your medical condition, response to||
3005|038|H|treatment, and other medications you may be taking. Children's||
3005|039|H|dosage is also based on weight. To reduce your risk of side||
3005|040|H|effects, your doctor may direct you to start this medication at a||
3005|041|H|low dose and gradually increase your dose. Follow your doctor's||
3005|042|H|instructions carefully. Be sure to tell your doctor and||
3005|043|H|pharmacist about all the products you use (including prescription||
3005|044|H|drugs, nonprescription drugs, and herbal products).||
3005|045|H|   Use this medication regularly to get the most benefit from it.||
3005|046|H|To help you remember, take it at the same times each day.||
3005|047|H|   Do not stop taking this medication without consulting your||
3005|048|H|doctor. Some conditions (such as seizures) may become worse when||
3005|049|H|this drug is suddenly stopped. Your dose may need to be gradually||
3005|050|H|decreased.||
3005|051|H|   Tell your doctor if your seizures get worse.||
3005|052|B|||
3005|053|S|SIDE EFFECTS:  Dizziness, drowsiness, tiredness, nausea/vomiting,||
3005|054|S|stomach/abdominal pain, headache, trouble sleeping, or||
3005|055|S|constipation may occur. If any of these effects last or get||
3005|056|S|worse, tell your doctor or pharmacist promptly.||
3005|057|S|   Remember that this medication has been prescribed because your||
3005|058|S|doctor has judged that the benefit to you is greater than the||
3005|059|S|risk of side effects. Many people using this medication do not||
3005|060|S|have serious side effects.||
3005|061|S|   A small number of people who take anticonvulsants for any||
3005|062|S|condition (such as seizure, bipolar disorder, pain) may||
3005|063|S|experience depression, suicidal thoughts/attempts, or other||
3005|064|S|mental/mood problems. Tell your doctor right away if you or your||
3005|065|S|family/caregiver notice any unusual/sudden changes in your mood,||
3005|066|S|thoughts, or behavior including signs of depression, suicidal||
3005|067|S|thoughts/attempts, thoughts about harming yourself.||
3005|068|S|   Tell your doctor right away if you have any serious side||
3005|069|S|effects, including: loss of coordination, vision changes (such as||
3005|070|S|double vision), rapid/uncontrollable eye movements, shaking||
3005|071|S|(tremor), easy bleeding/bruising, unusual tiredness.||
3005|072|S|   Get medical help right away if you have any very serious side||
3005|073|S|effects, including: signs of infection (such as sore throat that||
3005|074|S|doesn't go away, fever, swollen lymph nodes, chills), symptoms of||
3005|075|S|low sodium level (severe nausea, extreme drowsiness, confusion,||
3005|076|S|seizures).||
3005|077|S|   Oxcarbazepine may rarely cause very serious (possibly fatal)||
3005|078|S|skin reactions. Some people in certain ethnic groups (including||
3005|079|S|people of Asian/South Asian descent) are at greater risk. Your||
3005|080|S|doctor may order a blood test to measure your risk before you||
3005|081|S|start this medication. If the blood test shows you are at greater||
3005|082|S|risk, your doctor should discuss the risks and benefits of||
3005|083|S|oxcarbazepine and other treatment choices with you. Such skin||
3005|084|S|reactions have developed mostly within the first few months of||
3005|085|S|treatment. Get medical help right away if you develop symptoms of||
3005|086|S|a serious skin reaction such as skin rash/blisters/peeling,||
3005|087|S|itching, or swelling. Ask your doctor or pharmacist for more||
3005|088|S|details.||
3005|089|S|   A very serious allergic reaction to this drug is rare.||
3005|090|S|However, get medical help right away if you notice any symptoms||
3005|091|S|of a serious allergic reaction, including: rash, itching/swelling||
3005|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3005|093|S|breathing.||
3005|094|S|   This is not a complete list of possible side effects. If you||
3005|095|S|notice other effects not listed above, contact your doctor or||
3005|096|S|pharmacist.||
3005|097|S|   In the US -||
3005|098|S|   Call your doctor for medical advice about side effects. You||
3005|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3005|100|S|www.fda.gov/medwatch.||
3005|101|S|   In Canada - Call your doctor for medical advice about side||
3005|102|S|effects. You may report side effects to Health Canada at||
3005|103|S|1-866-234-2345.||
3005|104|B|||
3005|105|P|PRECAUTIONS:  Before taking oxcarbazepine, tell your doctor or||
3005|106|P|pharmacist if you are allergic to it; or to carbamazepine or||
3005|107|P|eslicarbazepine; or to other anti-seizure medications (such as||
3005|108|P|fosphenytoin, phenobarbital, phenytoin, primidone); or if you||
3005|109|P|have any other allergies. This product may contain inactive||
3005|110|P|ingredients, which can cause allergic reactions or other||
3005|111|P|problems. Talk to your pharmacist for more details.||
3005|112|P|   Before using this medication, tell your doctor or pharmacist||
3005|113|P|your medical history, especially of: kidney disease, mineral||
3005|114|P|imbalance (low level of sodium in the blood).||
3005|115|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3005|116|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3005|117|P|machinery, or do anything that needs alertness until you can do||
3005|118|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
3005|119|P|are using marijuana (cannabis).||
3005|120|P|   Before having surgery, tell your doctor or dentist about all||
3005|121|P|the products you use (including prescription drugs,||
3005|122|P|nonprescription drugs, and herbal products).||
3005|123|P|   Younger children may be more sensitive to the side effects of||
3005|124|P|this drug, especially infections.||
3005|125|P|   During pregnancy, this medication should be used only when||
3005|126|P|clearly needed. It may harm an unborn baby. However, since||
3005|127|P|untreated seizures are a serious condition that can harm both a||
3005|128|P|pregnant woman and her unborn baby, do not stop taking this||
3005|129|P|medication unless directed by your doctor. If you are planning||
3005|130|P|pregnancy, become pregnant, or think you may be pregnant, discuss||
3005|131|P|with your doctor right away the benefits and risks of using this||
3005|132|P|medication during pregnancy. Since hormonal birth control may not||
3005|133|P|work if taken with this medication (see also Drug Interactions||
3005|134|P|section), discuss reliable forms of birth control with your||
3005|135|P|doctor.||
3005|136|P|   This medication passes into breast milk but is unlikely to||
3005|137|P|harm a nursing infant. Consult your doctor before breastfeeding.||
3005|138|B|||
3005|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3005|140|I|medications work or increase your risk for serious side effects.||
3005|141|I|This document does not contain all possible drug interactions.||
3005|142|I|Keep a list of all the products you use (including||
3005|143|I|prescription/nonprescription drugs and herbal products) and share||
3005|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
3005|145|I|the dosage of any medicines without your doctor's approval.||
3005|146|I|   A product that may interact with this drug is: orlistat.||
3005|147|I|   This medication can speed up or slow down the removal of other||
3005|148|I|medications from your body, which may affect how they work.||
3005|149|I|Examples of affected drugs include cabotegravir, cobicistat,||
3005|150|I|elvitegravir, sofosbuvir, rilpivirine, among others.||
3005|151|I|   This medication may decrease the effectiveness of hormonal||
3005|152|I|birth control such as pills, patch, or ring. This could cause||
3005|153|I|pregnancy. Discuss with your doctor or pharmacist if you should||
3005|154|I|use reliable backup birth control methods while using this||
3005|155|I|medication. Also tell your doctor if you have any new spotting or||
3005|156|I|breakthrough bleeding, because these may be signs that your birth||
3005|157|I|control is not working well.||
3005|158|I|   Tell your doctor or pharmacist if you are taking other||
3005|159|I|products that cause drowsiness including alcohol, marijuana||
3005|160|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
3005|161|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
3005|162|I|zolpidem), muscle relaxants (such as carisoprodol,||
3005|163|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
3005|164|I|hydrocodone).||
3005|165|I|   Check the labels on all your medicines (such as allergy or||
3005|166|I|cough-and-cold products) because they may contain ingredients||
3005|167|I|that cause drowsiness. Ask your pharmacist about using those||
3005|168|I|products safely.||
3005|169|I|   Oxcarbazepine is very similar to eslicarbazepine. Do not use||
3005|170|I|medications containing eslicarbazepine while using oxcarbazepine.||
3005|171|B|||
3005|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3005|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3005|174|O|poison control center right away. US residents can call||
3005|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3005|176|B|||
3005|177|N|NOTES:  Do not share this medication with others.||
3005|178|N|   Lab and/or medical tests (such as sodium levels, complete||
3005|179|N|blood count) should be done while you are taking this medication.||
3005|180|N|Keep all medical and lab appointments. Consult your doctor for||
3005|181|N|more details.||
3005|182|B|||
3005|183|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3005|184|D|remember. If it is near the time of the next dose, skip the||
3005|185|D|missed dose. Take your next dose at the regular time. Do not||
3005|186|D|double the dose to catch up.||
3005|187|B|||
3005|188|R|STORAGE:  Store in the original container at room temperature.||
3005|189|R|Once the bottle is opened, this medication expires after 7 weeks.||
3005|190|R|Keep all medications away from children and pets.||
3005|191|R|   Do not flush medications down the toilet or pour them into a||
3005|192|R|drain unless instructed to do so. Properly discard this product||
3005|193|R|when it is expired or no longer needed. Consult your pharmacist||
3005|194|R|or local waste disposal company.||
3005|195|B|||
3005|196|M|MEDICAL ALERT:  Your condition can cause complications in a||
3005|197|M|medical emergency. For information about enrolling in MedicAlert,||
3005|198|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3005|199|B|||
3005|200|A|Information last revised May 2025.||
3005|201|A|Copyright(c) 2025 First Databank, Inc.||
3005|202|B|||
3006|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3006|002|Z|does NOT have all possible information about this product. This||
3006|003|Z|information does not assure that this product is safe, effective,||
3006|004|Z|or appropriate for you. This information is not individual||
3006|005|Z|medical advice and does not substitute for the advice of your||
3006|006|Z|health care professional. Always ask your health care||
3006|007|Z|professional for complete information about this product and your||
3006|008|Z|specific health needs.||
3006|009|B|||
3006|010|T|CLOBAZAM - ORAL||
3006|011|F|(KLO-buh-zamm)||
3006|012|B|||
3006|013|C|COMMON BRAND NAME(S): Onfi||
3006|014|B|||
3006|015|W|WARNING:  Clobazam has a risk for abuse and addiction, which can||
3006|016|W|lead to overdose and death. Taking this medication with alcohol||
3006|017|W|or other drugs that can cause drowsiness or breathing problems||
3006|018|W|(especially opioid medications such as codeine, hydrocodone) may||
3006|019|W|cause very serious side effects, including death. To lower your||
3006|020|W|risk, your doctor should have you take the smallest dose of||
3006|021|W|clobazam that works, and take it for the shortest possible time.||
3006|022|W|Be sure you know how to take clobazam and what other drugs you||
3006|023|W|should avoid taking with it. See also Drug Interactions section.||
3006|024|W|Get medical help right away if any of these very serious side||
3006|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
3006|026|W|severe drowsiness/dizziness, difficulty waking up.||
3006|027|W|   Suddenly stopping this medication may cause serious (possibly||
3006|028|W|fatal) withdrawal, especially if you have used it for a long time||
3006|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
3006|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
3006|031|W|you have any withdrawal symptoms such as headaches, trouble||
3006|032|W|sleeping, restlessness, hallucinations/confusion, depression,||
3006|033|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
3006|034|W|to months.||
3006|035|B|||
3006|036|U|USES:  This medication is used with other medications to help||
3006|037|U|control seizures. It belongs to a class of medications called||
3006|038|U|benzodiazepines, which act on the brain and nerves (central||
3006|039|U|nervous system) to produce a calming effect. This drug works by||
3006|040|U|enhancing the effects of a certain natural chemical in the body||
3006|041|U|(GABA).||
3006|042|B|||
3006|043|H|HOW TO USE:  See also Warning section.||
3006|044|H|   Read the Medication Guide provided by your pharmacist before||
3006|045|H|you start taking clobazam and each time you get a refill. If you||
3006|046|H|have any questions, ask your doctor or pharmacist.||
3006|047|H|   Take this medication by mouth with or without food as directed||
3006|048|H|by your doctor. If unable to swallow tablets, they may be crushed||
3006|049|H|and mixed with applesauce.||
3006|050|H|   If you are using the liquid form of this medication, read the||
3006|051|H|Instructions for Use if available from your pharmacist before you||
3006|052|H|start taking clobazam and each time you get a refill. Shake the||
3006|053|H|medication well before each dose. Carefully measure the dose||
3006|054|H|using a special measuring device/syringe. Do not use a household||
3006|055|H|spoon because you may not get the correct dose. If your||
3006|056|H|medication comes in an oral dosing syringe, use the syringe to||
3006|057|H|measure the dose. If you have any questions, ask your pharmacist.||
3006|058|H|   If you are taking this medication once daily, then take it at||
3006|059|H|bedtime. If you are taking this medication in divided doses, take||
3006|060|H|the largest dose at bedtime.||
3006|061|H|   The dosage is based on your medical condition and response to||
3006|062|H|treatment. Infant's dosage may also be based on weight.||
3006|063|H|   Use this medication regularly to get the most benefit from it.||
3006|064|H|To help you remember, take it at the same time(s) each day.||
3006|065|H|   Though it helps many people, this medication may sometimes||
3006|066|H|cause addiction. This risk may be higher if you have a substance||
3006|067|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
3006|068|H|Do not increase your dose, take it more often, or use it for a||
3006|069|H|longer time than prescribed. Properly stop the medication when so||
3006|070|H|directed.||
3006|071|H|   When used for an extended period, this medication may not work||
3006|072|H|as well and may require different dosing. Talk with your doctor||
3006|073|H|if this medication stops working well.||
3006|074|H|   Tell your doctor if your condition lasts or gets worse.||
3006|075|B|||
3006|076|S|SIDE EFFECTS:  See also Warning section.||
3006|077|S|   Drowsiness, dizziness, tiredness, headache, constipation,||
3006|078|S|weight gain, cough, drooling, trouble sleeping, or nausea may||
3006|079|S|occur. If any of these effects last or get worse, tell your||
3006|080|S|doctor or pharmacist promptly.||
3006|081|S|   Remember that this medication has been prescribed because your||
3006|082|S|doctor has judged that the benefit to you is greater than the||
3006|083|S|risk of side effects. Many people using this medication do not||
3006|084|S|have serious side effects.||
3006|085|S|   Tell your doctor right away if you have any serious side||
3006|086|S|effects, including: mental/mood/behavior changes (such as||
3006|087|S|agitation, nervousness, confusion, memory loss), muscle weakness,||
3006|088|S|loss of coordination, shaking (tremor) of the fingers, vision||
3006|089|S|changes (such as blurred vision, double vision), trouble||
3006|090|S|speaking, painful urination.||
3006|091|S|   A small number of people who take anticonvulsants for any||
3006|092|S|condition may experience depression, suicidal thoughts/attempts,||
3006|093|S|or other mental/mood problems. Tell your doctor right away if you||
3006|094|S|or your family/caregiver notice any unusual/sudden changes in||
3006|095|S|your mood, thoughts, or behavior including signs of depression,||
3006|096|S|suicidal thoughts/attempts, thoughts about harming yourself.||
3006|097|S|   Get medical help right away if you have any very serious side||
3006|098|S|effects, including: slow/shallow breathing.||
3006|099|S|   Clobazam may rarely cause very serious (possibly fatal) skin||
3006|100|S|reactions, especially during the first 8 weeks of treatment or||
3006|101|S|when restarting treatment with this medication. Get medical help||
3006|102|S|right away if you develop any of the following symptoms: skin||
3006|103|S|rash/blisters/peeling, itching, or mouth sores. If you have a||
3006|104|S|very serious skin reaction and your doctor says it was caused by||
3006|105|S|clobazam, you should not take the medication again. Ask your||
3006|106|S|doctor or pharmacist for more details.||
3006|107|S|   A very serious allergic reaction to this drug is rare.||
3006|108|S|However, get medical help right away if you notice any symptoms||
3006|109|S|of a serious allergic reaction, including: fever, swollen lymph||
3006|110|S|nodes, rash, itching/swelling (especially of the||
3006|111|S|face/tongue/throat), severe dizziness, trouble breathing.||
3006|112|S|   This is not a complete list of possible side effects. If you||
3006|113|S|notice other effects not listed above, contact your doctor or||
3006|114|S|pharmacist.||
3006|115|S|   In the US -||
3006|116|S|   Call your doctor for medical advice about side effects. You||
3006|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3006|118|S|www.fda.gov/medwatch.||
3006|119|S|   In Canada - Call your doctor for medical advice about side||
3006|120|S|effects. You may report side effects to Health Canada at||
3006|121|S|1-866-234-2345.||
3006|122|B|||
3006|123|P|PRECAUTIONS:  Before taking clobazam, tell your doctor or||
3006|124|P|pharmacist if you are allergic to it; or to other benzodiazepines||
3006|125|P|(such as diazepam); or if you have any other allergies. This||
3006|126|P|product may contain inactive ingredients, which can cause||
3006|127|P|allergic reactions or other problems. Talk to your pharmacist for||
3006|128|P|more details.||
3006|129|P|   Before using this medication, tell your doctor or pharmacist||
3006|130|P|your medical history, especially of: muscle disorders (such as||
3006|131|P|myasthenia gravis, weakness, loss of coordination), personal or||
3006|132|P|family history of a substance use disorder (such as overuse of or||
3006|133|P|addiction to drugs/alcohol), liver disease, glaucoma, mental/mood||
3006|134|P|disorders (such as depression, psychosis), breathing problems||
3006|135|P|(such as asthma, chronic obstructive pulmonary disease-COPD,||
3006|136|P|sleep apnea).||
3006|137|P|   Before having surgery, tell your doctor or dentist about all||
3006|138|P|the products you use (including prescription drugs,||
3006|139|P|nonprescription drugs, and herbal products).||
3006|140|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3006|141|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3006|142|P|machinery, or do anything that needs alertness until you can do||
3006|143|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
3006|144|P|are using marijuana (cannabis). Alcohol may also increase the||
3006|145|P|drug levels.||
3006|146|P|   Older adults may be more sensitive to the effects of the drug,||
3006|147|P|especially drowsiness. This drug may also cause excitement||
3006|148|P|instead of drowsiness in older adults.||
3006|149|P|   Children may be more sensitive to the effects of the drug.||
3006|150|P|This drug can often cause excitement in young children instead of||
3006|151|P|drowsiness.||
3006|152|P|   During pregnancy, this medication should be used only when||
3006|153|P|clearly needed. It may harm an unborn baby. Newborn babies of||
3006|154|P|mothers who use this medication late in pregnancy may have||
3006|155|P|symptoms such as slow/shallow breathing, nonstop crying, shaking,||
3006|156|P|or trouble feeding. However, since untreated seizures are a||
3006|157|P|serious condition that can harm both a pregnant woman and her||
3006|158|P|unborn baby, do not stop taking this medication unless directed||
3006|159|P|by your doctor. If you are planning pregnancy, become pregnant,||
3006|160|P|or think you may be pregnant, talk to your doctor right away||
3006|161|P|about the risks and benefits of this medication. Since birth||
3006|162|P|control pills, patches, implants, and injections may not work if||
3006|163|P|taken with this medication (see also Drug Interactions section),||
3006|164|P|discuss reliable forms of birth control with your doctor.||
3006|165|P|   This drug passes into breast milk and may have undesirable||
3006|166|P|effects on a nursing infant. Consult your doctor before||
3006|167|P|breastfeeding.||
3006|168|B|||
3006|169|I|DRUG INTERACTIONS:  See also Warning section.||
3006|170|I|   Drug interactions may change how your medications work or||
3006|171|I|increase your risk for serious side effects. This document does||
3006|172|I|not contain all possible drug interactions. Keep a list of all||
3006|173|I|the products you use (including prescription/nonprescription||
3006|174|I|drugs and herbal products) and share it with your doctor and||
3006|175|I|pharmacist. Do not start, stop, or change the dosage of any||
3006|176|I|medicines without your doctor's approval.||
3006|177|I|   Some products that may interact with this drug include:||
3006|178|I|orlistat, sodium oxybate.||
3006|179|I|   Other medications can affect the removal of clobazam from your||
3006|180|I|body, which may affect how clobazam works. Examples include||
3006|181|I|fluconazole, fluvoxamine, among others.||
3006|182|I|   The risk of serious side effects (such as slow/shallow||
3006|183|I|breathing, severe drowsiness/dizziness) may be increased if this||
3006|184|I|medication is taken with other products that may also cause||
3006|185|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
3006|186|I|if you are taking other products such as opioid pain or cough||
3006|187|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3006|188|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3006|189|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3006|190|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
3006|191|I|diphenhydramine).||
3006|192|I|   Check the labels on all your medicines (such as allergy or||
3006|193|I|cough-and-cold products) because they may contain ingredients||
3006|194|I|that cause drowsiness. Ask your pharmacist about using those||
3006|195|I|products safely.||
3006|196|I|   This medication may decrease the effectiveness of hormonal||
3006|197|I|birth control such as pills, patch, or ring. This could cause||
3006|198|I|pregnancy. Discuss with your doctor or pharmacist if you should||
3006|199|I|use reliable backup birth control methods while using this||
3006|200|I|medication. Also tell your doctor if you have any new spotting or||
3006|201|I|breakthrough bleeding, because these may be signs that your birth||
3006|202|I|control is not working well.||
3006|203|B|||
3006|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3006|205|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3006|206|O|poison control center right away. US residents can call||
3006|207|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3006|208|O|Symptoms of overdose may include: confusion, weakness, severe||
3006|209|O|drowsiness/dizziness, slow/shallow breathing, loss of||
3006|210|O|consciousness, slowed/decreased reflexes.||
3006|211|B|||
3006|212|N|NOTES:  Do not share this medication with others. Sharing it is||
3006|213|N|against the law.||
3006|214|N|   Lab and/or medical tests (such as complete blood count,||
3006|215|N|liver/kidney/thyroid function) may be done while you are taking||
3006|216|N|this medication. Keep all medical and lab appointments. Consult||
3006|217|N|your doctor for more details.||
3006|218|B|||
3006|219|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3006|220|D|remember. If it is near the time of the next dose, skip the||
3006|221|D|missed dose. Take your next dose at the regular time. Do not||
3006|222|D|double the dose to catch up.||
3006|223|B|||
3006|224|R|STORAGE:  Store at room temperature away from light and moisture.||
3006|225|R|Do not store in the bathroom.||
3006|226|R|   Different brands of the liquid form of this medication have||
3006|227|R|different storage needs. Check the product package for||
3006|228|R|instructions on how to store your brand, or ask your pharmacist.||
3006|229|R|Keep all medications away from children and pets.||
3006|230|R|   Do not flush medications down the toilet or pour them into a||
3006|231|R|drain unless instructed to do so. Properly discard this product||
3006|232|R|when it is expired or no longer needed. Consult your pharmacist||
3006|233|R|or local waste disposal company.||
3006|234|B|||
3006|235|M|MEDICAL ALERT:  Your condition can cause complications in a||
3006|236|M|medical emergency. For information about enrolling in MedicAlert,||
3006|237|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3006|238|B|||
3006|239|A|Information last revised March 2025.||
3006|240|A|Copyright(c) 2025 First Databank, Inc.||
3006|241|B|||
3008|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3008|002|Z|does NOT have all possible information about this product. This||
3008|003|Z|information does not assure that this product is safe, effective,||
3008|004|Z|or appropriate for you. This information is not individual||
3008|005|Z|medical advice and does not substitute for the advice of your||
3008|006|Z|health care professional. Always ask your health care||
3008|007|Z|professional for complete information about this product and your||
3008|008|Z|specific health needs.||
3008|009|B|||
3008|010|T|ALBUTEROL (SALBUTAMOL) SOLUTION - INHALATION||
3008|011|F|(al-BUE-ter-ol/sal-BUE-ta-mol)||
3008|012|B|||
3008|013|C|COMMON BRAND NAME(S): Proventil, Ventolin||
3008|014|B|||
3008|015|U|USES:  Albuterol (also known as salbutamol) is used to treat||
3008|016|U|wheezing and shortness of breath caused by breathing problems||
3008|017|U|such as asthma. It is a quick-relief medication. Albuterol||
3008|018|U|belongs to a class of drugs known as bronchodilators. It works by||
3008|019|U|relaxing the muscles around the airways so that they open up and||
3008|020|U|you can breathe more easily. Controlling symptoms of breathing||
3008|021|U|problems can decrease time lost from work or school.||
3008|022|B|||
3008|023|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
3008|024|H|your pharmacist before you start using this medication and each||
3008|025|H|time you get a refill. This medication is used with a special||
3008|026|H|machine called a nebulizer that changes the solution to a fine||
3008|027|H|mist that you inhale. Learn all instructions for the use of this||
3008|028|H|medication and the nebulizer. If a child is using this||
3008|029|H|medication, a parent or other responsible adult should supervise||
3008|030|H|the child. If you have any questions, ask your doctor,||
3008|031|H|pharmacist, or respiratory therapist.||
3008|032|H|   This product should be clear and colorless to light yellow.||
3008|033|H|Before using, check this product for particles or discoloration.||
3008|034|H|If either is present, do not use the liquid. Use the dropper||
3008|035|H|supplied by the manufacturer to carefully measure the prescribed||
3008|036|H|amount of medication and place in the nebulizer with sterile||
3008|037|H|saline as directed. If you are using the single dose package,||
3008|038|H|empty the contents of the package in the nebulizer and add||
3008|039|H|sterile saline as directed. Gently swirl the nebulizer to mix the||
3008|040|H|solution.||
3008|041|H|   Do not rinse the dropper. Replace the dropper and tightly||
3008|042|H|close the bottle after each use. To avoid contamination, do not||
3008|043|H|touch the dropper tip or let it touch any other surface. Discard||
3008|044|H|any unused mixed solution. Do not save for future use.||
3008|045|H|   Using a mouthpiece or face mask with the nebulizer, inhale the||
3008|046|H|prescribed dose of medication into your lungs as directed by your||
3008|047|H|doctor, usually 3 or 4 times daily as needed. Each treatment||
3008|048|H|usually takes about 5 to 15 minutes. Use this medication only||
3008|049|H|through a nebulizer. Do not swallow or inject the solution. Do||
3008|050|H|not mix with other medicines in your nebulizer. To prevent||
3008|051|H|infections, clean the nebulizer and mouthpiece/face mask||
3008|052|H|according to the manufacturer's directions.||
3008|053|H|   Dosage is based on your medical condition, age, weight, and||
3008|054|H|response to treatment. Do not increase your dose or use this drug||
3008|055|H|more often than prescribed without your doctor's approval. Using||
3008|056|H|too much of this medication will increase your risk of serious||
3008|057|H|(possibly fatal) side effects.||
3008|058|H|   Learn which of your inhalers/medications you should use every||
3008|059|H|day (controller drugs) and which you should use if your breathing||
3008|060|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
3008|061|H|time what you should do if you have new or worsening cough or||
3008|062|H|shortness of breath, wheezing, increased sputum, worsening peak||
3008|063|H|flow meter readings, waking up at night with trouble breathing,||
3008|064|H|if you use your quick-relief inhaler/medication more often (more||
3008|065|H|than 2 days a week), or if your quick-relief inhaler/medication||
3008|066|H|does not seem to be working well. Learn when you can treat sudden||
3008|067|H|breathing problems by yourself and when you must get medical help||
3008|068|H|right away.||
3008|069|H|   Tell your doctor if your symptoms do not get better or if they||
3008|070|H|get worse.||
3008|071|B|||
3008|072|S|SIDE EFFECTS:  Nervousness, shaking (tremor), headache, nausea or||
3008|073|S|dizziness may occur. If any of these effects last or get worse,||
3008|074|S|tell your doctor or pharmacist promptly.||
3008|075|S|   Remember that this medication has been prescribed because your||
3008|076|S|doctor has judged that the benefit to you is greater than the||
3008|077|S|risk of side effects. Many people using this medication do not||
3008|078|S|have serious side effects.||
3008|079|S|   This medication may raise your blood pressure. Check your||
3008|080|S|blood pressure regularly and tell your doctor if the results are||
3008|081|S|high.||
3008|082|S|   Tell your doctor right away if you have any serious side||
3008|083|S|effects, including: fast/pounding heartbeat.||
3008|084|S|   Get medical help right away if you have any very serious side||
3008|085|S|effects, including: chest pain, irregular heartbeat, rapid||
3008|086|S|breathing, confusion.||
3008|087|S|   Rarely, this medication has caused severe (rarely fatal),||
3008|088|S|sudden worsening of breathing problems/asthma (paradoxical||
3008|089|S|bronchospasm). If you experience sudden wheezing, get medical||
3008|090|S|help right away.||
3008|091|S|   A very serious allergic reaction to this drug is rare.||
3008|092|S|However, get medical help right away if you notice any symptoms||
3008|093|S|of a serious allergic reaction, including: rash, itching/swelling||
3008|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3008|095|S|breathing.||
3008|096|S|   This is not a complete list of possible side effects. If you||
3008|097|S|notice other effects not listed above, contact your doctor or||
3008|098|S|pharmacist.||
3008|099|S|   In the US -||
3008|100|S|   Call your doctor for medical advice about side effects. You||
3008|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3008|102|S|www.fda.gov/medwatch.||
3008|103|S|   In Canada - Call your doctor for medical advice about side||
3008|104|S|effects. You may report side effects to Health Canada at||
3008|105|S|1-866-234-2345.||
3008|106|B|||
3008|107|P|PRECAUTIONS:  Before using albuterol, tell your doctor or||
3008|108|P|pharmacist if you are allergic to it; or if you have had a||
3008|109|P|serious reaction to similar drugs (such as levalbuterol,||
3008|110|P|metaproterenol, terbutaline); or if you have any other allergies.||
3008|111|P|This product may contain inactive ingredients, which can cause||
3008|112|P|allergic reactions or other problems. Talk to your pharmacist for||
3008|113|P|more details.||
3008|114|P|   Before using this medication, tell your doctor or pharmacist||
3008|115|P|your medical history, especially of: heart problems (such as||
3008|116|P|irregular heartbeat, angina, heart attack), high blood pressure,||
3008|117|P|diabetes, seizure.||
3008|118|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3008|119|P|can make you more dizzy. Do not drive, use machinery, or do||
3008|120|P|anything that needs alertness until you can do it safely. Limit||
3008|121|P|alcoholic beverages. Talk to your doctor if you are using||
3008|122|P|marijuana (cannabis).||
3008|123|P|   Before having surgery, tell your doctor or dentist about all||
3008|124|P|the products you use (including prescription drugs,||
3008|125|P|nonprescription drugs, and herbal products).||
3008|126|P|   During pregnancy, this medication should be used only when||
3008|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
3008|128|P|   It is unknown if this medication passes into breast milk.||
3008|129|P|Consult your doctor before breastfeeding.||
3008|130|B|||
3008|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3008|132|I|medications work or increase your risk for serious side effects.||
3008|133|I|This document does not contain all possible drug interactions.||
3008|134|I|Keep a list of all the products you use (including||
3008|135|I|prescription/nonprescription drugs and herbal products) and share||
3008|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
3008|137|I|the dosage of any medicines without your doctor's approval.||
3008|138|I|   Albuterol is very similar to levalbuterol. Do not use||
3008|139|I|medications containing levalbuterol while using albuterol.||
3008|140|B|||
3008|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3008|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3008|143|O|poison control center right away. US residents can call||
3008|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3008|145|O|Symptoms of overdose may include: fast/pounding/irregular||
3008|146|O|heartbeat, severe shaking (tremors), seizures.||
3008|147|B|||
3008|148|N|NOTES:  Do not share this medication with others.||
3008|149|N|   Lab and/or medical tests (such as lung function, blood||
3008|150|N|pressure) should be done while you are using this medication.||
3008|151|N|Keep all medical and lab appointments. Consult your doctor for||
3008|152|N|more details.||
3008|153|N|   Avoid allergens/irritants such as smoke, pollen, pet dander,||
3008|154|N|dust, or molds that may worsen breathing problems.||
3008|155|N|   Learn to use a peak flow meter, use it daily, and promptly||
3008|156|N|report worsening breathing problems (such as readings in the||
3008|157|N|yellow/red range, increased use of quick-relief inhalers).||
3008|158|N|   Ask your doctor or pharmacist whether you should have an||
3008|159|N|annual flu shot.||
3008|160|B|||
3008|161|D|MISSED DOSE:  If you are using this medication on a prescribed||
3008|162|D|schedule and miss a dose, use it as soon as you remember. If it||
3008|163|D|is near the time of the next dose, skip the missed dose. Use your||
3008|164|D|next dose at the regular time. Do not double the dose to catch||
3008|165|D|up.||
3008|166|B|||
3008|167|R|STORAGE:  Different brands of this medication have different||
3008|168|R|storage needs. Store at room temperature or in the refrigerator||
3008|169|R|as directed before opening. Do not freeze. This medication may||
3008|170|R|need to be refrigerated after opening. Check the product package||
3008|171|R|for instructions on how to store your brand, or ask your||
3008|172|R|pharmacist. Keep all medications away from children and pets.||
3008|173|R|   Do not flush medications down the toilet or pour them into a||
3008|174|R|drain unless instructed to do so. Properly discard this product||
3008|175|R|when it is expired or no longer needed. Consult your pharmacist||
3008|176|R|or local waste disposal company.||
3008|177|B|||
3008|178|M|MEDICAL ALERT:  Your condition can cause complications in a||
3008|179|M|medical emergency. For information about enrolling in MedicAlert,||
3008|180|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3008|181|B|||
3008|182|A|Information last revised November 2024.||
3008|183|A|Copyright(c) 2025 First Databank, Inc.||
3008|184|B|||
3010|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3010|002|Z|does NOT have all possible information about this product. This||
3010|003|Z|information does not assure that this product is safe, effective,||
3010|004|Z|or appropriate for you. This information is not individual||
3010|005|Z|medical advice and does not substitute for the advice of your||
3010|006|Z|health care professional. Always ask your health care||
3010|007|Z|professional for complete information about this product and your||
3010|008|Z|specific health needs.||
3010|009|B|||
3010|010|T|NIFEDIPINE SUSTAINED-RELEASE - ORAL||
3010|011|F|(nye-FED-i-peen)||
3010|012|B|||
3010|013|C|COMMON BRAND NAME(S): Procardia XL||
3010|014|B|||
3010|015|U|USES:  Nifedipine is used alone or in combination with other||
3010|016|U|drugs to treat high blood pressure (hypertension). Lowering high||
3010|017|U|blood pressure helps prevent strokes, heart attacks, and kidney||
3010|018|U|problems.||
3010|019|U|   This medication is also used for certain types of chest pain||
3010|020|U|(angina). It may help increase your ability to exercise and||
3010|021|U|decrease the frequency of chest pain attacks. It should not be||
3010|022|U|used to treat chest pain when it occurs. Use other medications||
3010|023|U|(such as sublingual nitroglycerin) to relieve attacks of chest||
3010|024|U|pain as directed by your doctor. Consult your doctor or||
3010|025|U|pharmacist for more details.||
3010|026|U|   This medication is known as a calcium channel blocker. It||
3010|027|U|works by relaxing and widening blood vessels so blood can flow||
3010|028|U|more easily.||
3010|029|B|||
3010|030|V|OTHER USES:  This section contains uses of this drug that are not||
3010|031|V|listed in the approved professional labeling for the drug but||
3010|032|V|that may be prescribed by your health care professional. Use this||
3010|033|V|drug for a condition that is listed in this section only if it||
3010|034|V|has been so prescribed by your health care professional.||
3010|035|V|   This drug may also be used for certain blood circulation||
3010|036|V|disorders (Raynaud's syndrome).||
3010|037|B|||
3010|038|H|HOW TO USE:  Take this medication by mouth with or without food||
3010|039|H|as directed by your doctor, usually once daily. Swallow the||
3010|040|H|tablets whole. Do not crush or chew the tablets. Doing so can||
3010|041|H|release all of the drug at once, increasing the risk of side||
3010|042|H|effects.||
3010|043|H|   Your doctor may gradually increase your dose. Follow your||
3010|044|H|doctor's instructions carefully. The dosage is based on your||
3010|045|H|medical condition and response to treatment.||
3010|046|H|   Avoid eating grapefruit or drinking grapefruit juice while||
3010|047|H|using this medication unless your doctor or pharmacist says you||
3010|048|H|may do so safely. Grapefruit can increase the chance of side||
3010|049|H|effects with this medicine. Ask your doctor or pharmacist for||
3010|050|H|more details.||
3010|051|H|   Use this medication regularly in order to get the most benefit||
3010|052|H|from it. Remember to take it at the same time each day. Keep||
3010|053|H|taking this medication even if you feel well. Most people with||
3010|054|H|high blood pressure do not feel sick.||
3010|055|H|   Do not suddenly stop taking this medication without consulting||
3010|056|H|your doctor. Your condition may become worse when the drug is||
3010|057|H|suddenly stopped. Your dose may need to be gradually decreased.||
3010|058|H|   Tell your doctor if your condition does not get better or if||
3010|059|H|it gets worse (for example, your blood pressure readings remain||
3010|060|H|high or increase).||
3010|061|B|||
3010|062|S|SIDE EFFECTS:  Headache, dizziness, nausea, flushing,||
3010|063|S|constipation, leg/muscle cramps, or sexual problems may occur. If||
3010|064|S|any of these effects last or get worse, tell your doctor or||
3010|065|S|pharmacist promptly.||
3010|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
3010|067|S|slowly when rising from a sitting or lying position.||
3010|068|S|   An empty tablet shell may appear in your stool. This is||
3010|069|S|harmless since your body has already absorbed the medication.||
3010|070|S|   Remember that this medication has been prescribed because your||
3010|071|S|doctor has judged that the benefit to you is greater than the||
3010|072|S|risk of side effects. Many people using this medication do not||
3010|073|S|have serious side effects.||
3010|074|S|   Tell your doctor right away if you have any serious side||
3010|075|S|effects, including: swelling of the ankles/feet, shortness of||
3010|076|S|breath, unusual weakness/tiredness, fast/slow/irregular||
3010|077|S|heartbeat, fainting, mental/mood changes, swollen/tender gums,||
3010|078|S|vision changes, severe constipation, severe stomach/abdominal||
3010|079|S|pain, black stools.||
3010|080|S|   Although this medication is effective in preventing chest pain||
3010|081|S|(angina), some people who already have severe heart disease may||
3010|082|S|rarely develop worsening chest pain or a heart attack after||
3010|083|S|starting this medication or increasing the dose. Get medical help||
3010|084|S|right away if you experience: worsening chest pain, symptoms of a||
3010|085|S|heart attack (such as chest/jaw/left arm pain, shortness of||
3010|086|S|breath, unusual sweating).||
3010|087|S|   A very serious allergic reaction to this drug is rare.||
3010|088|S|However, get medical help right away if you notice any symptoms||
3010|089|S|of a serious allergic reaction, including: rash, itching/swelling||
3010|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3010|091|S|breathing.||
3010|092|S|   This is not a complete list of possible side effects. If you||
3010|093|S|notice other effects not listed above, contact your doctor or||
3010|094|S|pharmacist.||
3010|095|S|   In the US -||
3010|096|S|   Call your doctor for medical advice about side effects. You||
3010|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3010|098|S|www.fda.gov/medwatch.||
3010|099|S|   In Canada - Call your doctor for medical advice about side||
3010|100|S|effects. You may report side effects to Health Canada at||
3010|101|S|1-866-234-2345.||
3010|102|B|||
3010|103|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
3010|104|P|pharmacist if you are allergic to it; or to other calcium channel||
3010|105|P|blockers (such as amlodipine, felodipine); or if you have any||
3010|106|P|other allergies. This product may contain inactive ingredients,||
3010|107|P|which can cause allergic reactions or other problems. Talk to||
3010|108|P|your pharmacist for more details.||
3010|109|P|   Before using this medication, tell your doctor or pharmacist||
3010|110|P|your medical history, especially of: heart diseases (such as||
3010|111|P|heart failure, aortic stenosis), liver problems,||
3010|112|P|esophagus/stomach/intestine problems (such as||
3010|113|P|narrowing/stricture, motility disorders, obstruction), kidney||
3010|114|P|problems, a certain metabolic disorder (porphyria).||
3010|115|P|   Before having surgery, tell your doctor or dentist about all||
3010|116|P|the products you use (including prescription drugs,||
3010|117|P|nonprescription drugs, and herbal products).||
3010|118|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3010|119|P|can make you more dizzy. Do not drive, use machinery, or do||
3010|120|P|anything that needs alertness until you can do it safely. Limit||
3010|121|P|alcoholic beverages. Talk to your doctor if you are using||
3010|122|P|marijuana (cannabis).||
3010|123|P|   During pregnancy, this medication should be used only when||
3010|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
3010|125|P|   Nifedipine passes into breast milk. Consult your doctor before||
3010|126|P|breastfeeding.||
3010|127|B|||
3010|128|I|DRUG INTERACTIONS:  See also How to Use section.||
3010|129|I|   Drug interactions may change how your medications work or||
3010|130|I|increase your risk for serious side effects. This document does||
3010|131|I|not contain all possible drug interactions. Keep a list of all||
3010|132|I|the products you use (including prescription/nonprescription||
3010|133|I|drugs and herbal products) and share it with your doctor and||
3010|134|I|pharmacist. Do not start, stop, or change the dosage of any||
3010|135|I|medicines without your doctor's approval.||
3010|136|I|   Other medications can affect the removal of nifedipine from||
3010|137|I|your body, which may affect how nifedipine works. Examples||
3010|138|I|include apalutamide, enzalutamide, mitotane, St. John's wort,||
3010|139|I|rifamycins (such as rifabutin, rifampin), drugs used to treat||
3010|140|I|seizures (such as carbamazepine, phenobarbital, phenytoin), among||
3010|141|I|others.||
3010|142|I|   Some products have ingredients that could raise your heart||
3010|143|I|rate or blood pressure. Tell your pharmacist what products you||
3010|144|I|are using, and ask how to use them safely (especially||
3010|145|I|cough-and-cold products, diet aids, or NSAIDs such as||
3010|146|I|ibuprofen/naproxen).||
3010|147|B|||
3010|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3010|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3010|150|O|poison control center right away. US residents can call||
3010|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3010|152|O|Symptoms of overdose may include: severe dizziness, fainting,||
3010|153|O|fast/slow/irregular heartbeat.||
3010|154|B|||
3010|155|N|NOTES:  Do not share this medication with others.||
3010|156|N|   Lifestyle changes such as stress reduction programs, exercise,||
3010|157|N|and dietary changes may increase the effectiveness of this||
3010|158|N|medicine. Talk to your doctor or pharmacist about lifestyle||
3010|159|N|changes that might benefit you.||
3010|160|N|   Lab and/or medical tests (such as liver/kidney function, EKG)||
3010|161|N|should be done while you are taking this medication. Keep all||
3010|162|N|medical and lab appointments. Consult your doctor for more||
3010|163|N|details.||
3010|164|N|   Have your blood pressure checked regularly while taking this||
3010|165|N|medication. Learn how to monitor your own blood pressure at home,||
3010|166|N|and share the results with your doctor.||
3010|167|B|||
3010|168|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3010|169|D|remember. If it is near the time of the next dose, skip the||
3010|170|D|missed dose. Take your next dose at the regular time. Do not||
3010|171|D|double the dose to catch up.||
3010|172|B|||
3010|173|R|STORAGE:  Store at room temperature away from light and moisture.||
3010|174|R|Do not store in the bathroom. Keep all medications away from||
3010|175|R|children and pets.||
3010|176|R|   Do not flush medications down the toilet or pour them into a||
3010|177|R|drain unless instructed to do so. Properly discard this product||
3010|178|R|when it is expired or no longer needed. Consult your pharmacist||
3010|179|R|or local waste disposal company.||
3010|180|B|||
3010|181|M|MEDICAL ALERT:  Your condition can cause complications in a||
3010|182|M|medical emergency. For information about enrolling in MedicAlert,||
3010|183|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3010|184|B|||
3010|185|A|Information last revised November 2025.||
3010|186|A|Copyright(c) 2025 First Databank, Inc.||
3010|187|B|||
3012|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3012|002|Z|does NOT have all possible information about this product. This||
3012|003|Z|information does not assure that this product is safe, effective,||
3012|004|Z|or appropriate for you. This information is not individual||
3012|005|Z|medical advice and does not substitute for the advice of your||
3012|006|Z|health care professional. Always ask your health care||
3012|007|Z|professional for complete information about this product and your||
3012|008|Z|specific health needs.||
3012|009|B|||
3012|010|T|CLEMASTINE - ORAL||
3012|011|F|(KLEM-ast-een)||
3012|012|B|||
3012|013|C|COMMON BRAND NAME(S): Tavist||
3012|014|B|||
3012|015|U|USES:  Clemastine is an antihistamine used to relieve symptoms of||
3012|016|U|allergy, hay fever, and the common cold. These symptoms include||
3012|017|U|rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny||
3012|018|U|nose, and sneezing. This medication works by blocking a certain||
3012|019|U|natural substance (histamine) that your body makes during an||
3012|020|U|allergic reaction. By blocking another natural substance made by||
3012|021|U|your body (acetylcholine), it helps dry up some body fluids to||
3012|022|U|relieve symptoms such as watery eyes and runny nose.||
3012|023|U|   Cough-and-cold products have not been shown to be safe or||
3012|024|U|effective in children younger than 6 years. Do not use this||
3012|025|U|product to treat cold symptoms in children younger than 6 years||
3012|026|U|unless specifically directed by the doctor. Some products (such||
3012|027|U|as long-acting tablets/capsules) are not recommended for use in||
3012|028|U|children younger than 12 years. Ask your doctor or pharmacist for||
3012|029|U|more details about using your product safely.||
3012|030|U|   These products do not cure or shorten the length of the common||
3012|031|U|cold and may cause serious side effects. To decrease the risk for||
3012|032|U|serious side effects, carefully follow all dosage directions. Do||
3012|033|U|not use this product to make a child sleepy. Do not give other||
3012|034|U|cough-and-cold medication that might contain the same or similar||
3012|035|U|ingredients (see also Drug Interactions section). Ask the doctor||
3012|036|U|or pharmacist about other ways to relieve cough and cold symptoms||
3012|037|U|(such as drinking enough fluids, using a humidifier or saline||
3012|038|U|nose drops/spray).||
3012|039|B|||
3012|040|H|HOW TO USE:  If you are taking the over-the-counter product, read||
3012|041|H|all directions on the product package before taking this||
3012|042|H|medication. If you have any questions, consult your pharmacist.||
3012|043|H|If your doctor has prescribed this medication, take it as||
3012|044|H|directed.||
3012|045|H|   Take the tablet or liquid form by mouth with or without food.||
3012|046|H|Follow the directions for dosing on the label, or take as||
3012|047|H|directed by your doctor. This medication may be taken with food||
3012|048|H|or milk if stomach upset occurs.||
3012|049|H|   If you are using the liquid form of this medication, carefully||
3012|050|H|measure the dose using a special measuring device/spoon. Do not||
3012|051|H|use a household spoon because you may not get the correct dose.||
3012|052|H|   The dosage is based on your age, medical condition, and||
3012|053|H|response to treatment. Do not increase your dose or take this||
3012|054|H|medication more often than recommended by your doctor or the||
3012|055|H|package instructions without your doctor's approval. Take this||
3012|056|H|medication regularly in order to get the most benefit from it. To||
3012|057|H|help you remember, take it at the same time(s) each day.||
3012|058|H|   If your condition lasts or gets worse, or if you think you may||
3012|059|H|have a serious medical problem, get medical help right away.||
3012|060|B|||
3012|061|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, constipation,||
3012|062|S|stomach upset, blurred vision, trouble walking/clumsiness, or dry||
3012|063|S|mouth/nose/throat may occur. These effects may decrease as your||
3012|064|S|body adjusts to the medication. If any of these effects last or||
3012|065|S|get worse, contact your doctor or pharmacist promptly.||
3012|066|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
3012|067|S|chips, chew (sugarless) gum, drink water, or use a saliva||
3012|068|S|substitute. Clemastine can dry up and thicken mucus in your||
3012|069|S|lungs, making it more difficult to breathe and clear your lungs.||
3012|070|S|To help prevent this effect, drink plenty of fluids unless||
3012|071|S|otherwise directed by your doctor.||
3012|072|S|   To reduce the risk of dizziness and lightheadedness, get up||
3012|073|S|slowly when rising from a sitting or lying position.||
3012|074|S|   If your doctor has prescribed this medication, remember that||
3012|075|S|your doctor has judged that the benefit to you is greater than||
3012|076|S|the risk of side effects. Many people using this medication do||
3012|077|S|not have serious side effects.||
3012|078|S|   Tell your doctor right away if you have any serious side||
3012|079|S|effects, including: mental/mood changes (such as hallucinations,||
3012|080|S|irritability, nervousness, confusion), ringing in the ears,||
3012|081|S|trouble urinating, easy bruising/bleeding, fast/irregular||
3012|082|S|heartbeat, seizure.||
3012|083|S|   A very serious allergic reaction to this drug is rare.||
3012|084|S|However, get medical help right away if you notice any symptoms||
3012|085|S|of a serious allergic reaction, including: rash, itching/swelling||
3012|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3012|087|S|breathing.||
3012|088|S|   This is not a complete list of possible side effects. If you||
3012|089|S|notice other effects not listed above, contact your doctor or||
3012|090|S|pharmacist.||
3012|091|S|   In the US -||
3012|092|S|   Call your doctor for medical advice about side effects. You||
3012|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3012|094|S|www.fda.gov/medwatch.||
3012|095|S|   In Canada - Call your doctor for medical advice about side||
3012|096|S|effects. You may report side effects to Health Canada at||
3012|097|S|1-866-234-2345.||
3012|098|B|||
3012|099|P|PRECAUTIONS:  Before taking clemastine, tell your doctor or||
3012|100|P|pharmacist if you are allergic to it; or if you have any other||
3012|101|P|allergies. This product may contain inactive ingredients, which||
3012|102|P|can cause allergic reactions or other problems. Talk to your||
3012|103|P|pharmacist for more details.||
3012|104|P|   Before using this medication, tell your doctor or pharmacist||
3012|105|P|your medical history, especially of: breathing problems (such as||
3012|106|P|asthma, emphysema), a certain eye problem (glaucoma), heart||
3012|107|P|problems, high blood pressure, liver disease, seizures, stomach||
3012|108|P|problems (such as ulcers, blockage), overactive thyroid||
3012|109|P|(hyperthyroidism), urination problems (such as trouble urinating||
3012|110|P|due to enlarged prostate, urinary retention).||
3012|111|P|   This drug may make you dizzy or drowsy or blur your vision.||
3012|112|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3012|113|P|drowsy. Do not drive, use machinery, or do anything that needs||
3012|114|P|alertness or clear vision until you can do it safely. Limit||
3012|115|P|alcoholic beverages. Talk to your doctor if you are using||
3012|116|P|marijuana (cannabis).||
3012|117|P|   Liquid preparations of this product may contain sugar and/or||
3012|118|P|alcohol. Caution is advised if you have diabetes, alcohol||
3012|119|P|dependence, or liver disease. Ask your doctor or pharmacist about||
3012|120|P|the safe use of this product.||
3012|121|P|   Older adults may be more sensitive to the side effects of this||
3012|122|P|drug, especially drowsiness, constipation, problems urinating, or||
3012|123|P|confusion. Drowsiness and confusion can increase the risk of||
3012|124|P|falling.||
3012|125|P|   Children may be more sensitive to the effects of||
3012|126|P|antihistamines. In young children, this medication may cause||
3012|127|P|agitation/excitement instead of drowsiness.||
3012|128|P|   During pregnancy, this medication should be used only when||
3012|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
3012|130|P|   This drug passes into breast milk and may have undesirable||
3012|131|P|effects on a nursing infant. Consult your doctor before||
3012|132|P|breastfeeding.||
3012|133|B|||
3012|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3012|135|I|medications work or increase your risk for serious side effects.||
3012|136|I|This document does not contain all possible drug interactions.||
3012|137|I|Keep a list of all the products you use (including||
3012|138|I|prescription/nonprescription drugs and herbal products) and share||
3012|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
3012|140|I|the dosage of any medicines without your doctor's approval.||
3012|141|I|   Some products that may interact with this drug include:||
3012|142|I|antihistamines applied to the skin (such as diphenhydramine||
3012|143|I|cream, ointment, spray).||
3012|144|I|   Tell your doctor or pharmacist if you are taking other||
3012|145|I|products that cause drowsiness such as opioid pain or cough||
3012|146|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3012|147|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3012|148|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3012|149|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
3012|150|I|diphenhydramine).||
3012|151|I|   Check the labels on all your medicines (such as allergy or||
3012|152|I|cough-and-cold products) because they may contain ingredients||
3012|153|I|that cause drowsiness. Ask your pharmacist about using those||
3012|154|I|products safely.||
3012|155|B|||
3012|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3012|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3012|158|O|poison control center right away. US residents can call||
3012|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3012|160|O|Symptoms of overdose may include: large pupils, flushing, fever,||
3012|161|O|hallucinations, weakness, shaking (tremor), muscle twitching,||
3012|162|O|loss of consciousness, seizures. In children, excitement may||
3012|163|O|occur first, and may be followed by loss of coordination,||
3012|164|O|drowsiness, loss of consciousness, seizures.||
3012|165|B|||
3012|166|N|NOTES:  If your doctor has prescribed this medication, do not||
3012|167|N|share it with others.||
3012|168|N|   Keep all medical and lab appointments.||
3012|169|N|   Do not take for several days before allergy testing because||
3012|170|N|test results can be affected.||
3012|171|B|||
3012|172|D|MISSED DOSE:  If you are taking this medication on a regular||
3012|173|D|schedule and miss a dose, take it as soon as you remember. If it||
3012|174|D|is near the time of your next dose, skip the missed dose. Take||
3012|175|D|your next dose at the regular time. Do not double the dose to||
3012|176|D|catch up.||
3012|177|B|||
3012|178|R|STORAGE:  Store at room temperature away from light and moisture.||
3012|179|R|Do not store in the bathroom. Do not freeze liquid forms of this||
3012|180|R|medication. Keep all medications away from children and pets.||
3012|181|R|   Do not flush medications down the toilet or pour them into a||
3012|182|R|drain unless instructed to do so. Properly discard this product||
3012|183|R|when it is expired or no longer needed. Consult your pharmacist||
3012|184|R|or local waste disposal company.||
3012|185|B|||
3012|186|A|Information last revised June 2024.||
3012|187|A|Copyright(c) 2025 First Databank, Inc.||
3012|188|B|||
3013|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3013|002|Z|does NOT have all possible information about this product. This||
3013|003|Z|information does not assure that this product is safe, effective,||
3013|004|Z|or appropriate for you. This information is not individual||
3013|005|Z|medical advice and does not substitute for the advice of your||
3013|006|Z|health care professional. Always ask your health care||
3013|007|Z|professional for complete information about this product and your||
3013|008|Z|specific health needs.||
3013|009|B|||
3013|010|T|SOTALOL - ORAL||
3013|011|F|(SO-tuh-lol)||
3013|012|B|||
3013|013|C|COMMON BRAND NAME(S): Betapace, Betapace AF||
3013|014|B|||
3013|015|W|WARNING:  Sotalol should be used only in certain patients. Before||
3013|016|W|taking sotalol, discuss the risks and benefits of treatment with||
3013|017|W|your doctor. Although sotalol is effective for treating certain||
3013|018|W|types of fast/irregular heartbeats, it can rarely cause a new||
3013|019|W|serious abnormal heart rhythm (QT prolongation in the EKG). This||
3013|020|W|problem can lead to a new type of abnormal (possibly fatal)||
3013|021|W|heartbeat (torsade de pointes). If this new serious heart rhythm||
3013|022|W|occurs, it is usually when sotalol treatment is first started or||
3013|023|W|when the dose is increased. To reduce the risk of this side||
3013|024|W|effect, you should begin sotalol treatment in a hospital so your||
3013|025|W|doctor can monitor your heart rhythm for several days and treat||
3013|026|W|the problems if they occur. Patients usually start with a low||
3013|027|W|dose of sotalol. Your doctor will then slowly increase your dose||
3013|028|W|depending on how you respond to the medication and how well your||
3013|029|W|kidneys work. If you respond well to this medication, during this||
3013|030|W|time in the hospital your doctor can determine the right dose of||
3013|031|W|sotalol for you.||
3013|032|W|   Some sotalol products are used to treat certain types of||
3013|033|W|fast/irregular heartbeats (atrial fibrillation/flutter). These||
3013|034|W|products come with additional written information from the||
3013|035|W|manufacturer for patients with atrial fibrillation/flutter. If||
3013|036|W|you have these conditions, read the provided information||
3013|037|W|carefully. Do not switch brands of sotalol without checking with||
3013|038|W|your doctor.||
3013|039|W|   Do not stop taking this medication without consulting your||
3013|040|W|doctor. Some conditions may become worse when you suddenly stop||
3013|041|W|this drug. Some people who have suddenly stopped taking similar||
3013|042|W|drugs have had chest pain, heart attack, and irregular heartbeat.||
3013|043|W|If your doctor decides you should no longer use this drug, your||
3013|044|W|doctor may direct you to gradually decrease your dose over 1 to 2||
3013|045|W|weeks.||
3013|046|W|   When gradually stopping this medication, it is recommended||
3013|047|W|that you temporarily limit physical activity to decrease strain||
3013|048|W|on the heart. Get medical help right away if you develop: chest||
3013|049|W|pain/tightness/pressure, chest pain spreading to the||
3013|050|W|jaw/neck/arm, unusual sweating, trouble breathing, fast/irregular||
3013|051|W|heartbeat.||
3013|052|B|||
3013|053|U|USES:  This medication is used to treat a serious (possibly||
3013|054|U|life-threatening) type of fast heartbeat called sustained||
3013|055|U|ventricular tachycardia. It is also used to treat certain||
3013|056|U|fast/irregular heartbeats (atrial fibrillation/flutter) in||
3013|057|U|patients with severe symptoms such as weakness and shortness of||
3013|058|U|breath. Sotalol helps to lessen these symptoms. It slows the||
3013|059|U|heart rate and helps the heart to beat more normally and||
3013|060|U|regularly. This medication is both a beta blocker and an||
3013|061|U|anti-arrhythmic.||
3013|062|B|||
3013|063|H|HOW TO USE:  See also Warning section.||
3013|064|H|   Read the Patient Information Leaflet if available from your||
3013|065|H|pharmacist before you start using sotalol and each time you get a||
3013|066|H|refill. If you have any questions, ask your doctor or pharmacist.||
3013|067|H|   Take this medication by mouth as directed by your doctor,||
3013|068|H|usually 1 to 3 to times a day. You may take it with or without||
3013|069|H|food, but it is important to choose one way and take it the same||
3013|070|H|way with each dose.||
3013|071|H|   If you are using the liquid form of this medication, carefully||
3013|072|H|measure the dose using a special measuring device/spoon. Do not||
3013|073|H|use a household spoon because you may not get the correct dose.||
3013|074|H|   The dosage is based on your medical condition and response to||
3013|075|H|treatment. Children's dosage is also based on age and body size.||
3013|076|H|   Use this medication regularly to get the most benefit from it.||
3013|077|H|To help you remember, take it at the same time(s) each day.||
3013|078|H|   If you use antacids containing aluminum or magnesium, do not||
3013|079|H|take them at the same time as sotalol. These antacids can bind to||
3013|080|H|sotalol and decrease its absorption and effectiveness. Separate||
3013|081|H|doses of these antacids and sotalol by at least 2 hours to reduce||
3013|082|H|this interaction.||
3013|083|H|   Do not take more of this drug than prescribed because you may||
3013|084|H|increase your risk of side effects, including a new serious||
3013|085|H|abnormal heartbeat. Do not take less of this medication or skip||
3013|086|H|doses unless directed by your doctor. Your fast/irregular||
3013|087|H|heartbeat is more likely to return if you do not take sotalol||
3013|088|H|properly. Also, do not run out of this medication. Order your||
3013|089|H|refills several days early to avoid running out of pills.||
3013|090|H|   Tell your doctor if your condition does not get better or if||
3013|091|H|it gets worse.||
3013|092|B|||
3013|093|S|SIDE EFFECTS:  See also Warning section.||
3013|094|S|   Tiredness, slow heartbeat, and dizziness may occur. Less||
3013|095|S|common side effects include headache, diarrhea, and decreased||
3013|096|S|sexual ability. If any of these effects last or get worse, tell||
3013|097|S|your doctor or pharmacist promptly.||
3013|098|S|   To reduce the risk of dizziness and lightheadedness, get up||
3013|099|S|slowly when rising from a sitting or lying position.||
3013|100|S|   Remember that this medication has been prescribed because your||
3013|101|S|doctor has judged that the benefit to you is greater than the||
3013|102|S|risk of side effects. Many people using this medication do not||
3013|103|S|have serious side effects.||
3013|104|S|   Tell your doctor right away if you have any serious side||
3013|105|S|effects, including: new or worsening symptoms of heart failure||
3013|106|S|(such as shortness of breath, swelling ankles/feet, unusual||
3013|107|S|tiredness, unusual/sudden weight gain).||
3013|108|S|   Get medical help right away if you have any very serious side||
3013|109|S|effects, including: severe dizziness, fainting, sudden change in||
3013|110|S|heartbeat (unusually faster/slower/more irregular),||
3013|111|S|chest/jaw/left arm pain.||
3013|112|S|   A very serious allergic reaction to this drug is rare.||
3013|113|S|However, get medical help right away if you notice any symptoms||
3013|114|S|of a serious allergic reaction, including: rash, itching/swelling||
3013|115|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3013|116|S|breathing.||
3013|117|S|   This is not a complete list of possible side effects. If you||
3013|118|S|notice other effects not listed above, contact your doctor or||
3013|119|S|pharmacist.||
3013|120|S|   In the US -||
3013|121|S|   Call your doctor for medical advice about side effects. You||
3013|122|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3013|123|S|www.fda.gov/medwatch.||
3013|124|S|   In Canada - Call your doctor for medical advice about side||
3013|125|S|effects. You may report side effects to Health Canada at||
3013|126|S|1-866-234-2345.||
3013|127|B|||
3013|128|P|PRECAUTIONS:  See also Warning section.||
3013|129|P|   Before taking sotalol, tell your doctor or pharmacist if you||
3013|130|P|are allergic to it; or if you have any other allergies. This||
3013|131|P|product may contain inactive ingredients, which can cause||
3013|132|P|allergic reactions or other problems. Talk to your pharmacist for||
3013|133|P|more details.||
3013|134|P|   Before using this medication, tell your doctor or pharmacist||
3013|135|P|your medical history, especially of: certain heart rhythm||
3013|136|P|problems (such as a slow heartbeat, sick sinus syndrome, second-||
3013|137|P|or third-degree atrioventricular block unless you have a heart||
3013|138|P|pacemaker), kidney problems, heart problems (such as heart||
3013|139|P|failure, recent heart attack), breathing problems (such as||
3013|140|P|asthma, chronic bronchitis, emphysema), overactive thyroid||
3013|141|P|disease (hyperthyroidism), serious allergic reactions needing||
3013|142|P|treatment with epinephrine.||
3013|143|P|   Sotalol may cause a condition that affects the heart rhythm||
3013|144|P|(QT prolongation in the EKG). QT prolongation can rarely cause||
3013|145|P|serious (rarely fatal) fast/irregular heartbeat and other||
3013|146|P|symptoms (such as severe dizziness, fainting) that need medical||
3013|147|P|attention right away.||
3013|148|P|   The risk of QT prolongation may be increased if you have||
3013|149|P|certain medical conditions or are taking other drugs that may||
3013|150|P|cause QT prolongation. Before using sotalol, tell your doctor or||
3013|151|P|pharmacist of all the drugs you take and if you have any of the||
3013|152|P|following conditions: certain heart problems (QT prolongation in||
3013|153|P|the EKG, history of torsade de pointes), family history of||
3013|154|P|certain heart problems (QT prolongation in the EKG, sudden||
3013|155|P|cardiac death).||
3013|156|P|   Low levels of potassium or magnesium in the blood may also||
3013|157|P|increase your risk of QT prolongation. This risk may increase if||
3013|158|P|you use certain drugs (such as diuretics/"water pills"), if you||
3013|159|P|are unable to eat or drink fluids as you normally would, or if||
3013|160|P|you have conditions such as severe/prolonged sweating, diarrhea,||
3013|161|P|or vomiting. Talk to your doctor about using sotalol safely.||
3013|162|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3013|163|P|can make you more dizzy. Do not drive, use machinery, or do||
3013|164|P|anything that needs alertness until you can do it safely. Limit||
3013|165|P|alcoholic beverages. Talk to your doctor if you are using||
3013|166|P|marijuana (cannabis).||
3013|167|P|   Before having surgery, tell your doctor or dentist about all||
3013|168|P|the products you use (including prescription drugs,||
3013|169|P|nonprescription drugs, and herbal products).||
3013|170|P|   This product may prevent the fast/pounding heartbeat you would||
3013|171|P|usually feel when your blood sugar level falls too low||
3013|172|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
3013|173|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
3013|174|P|blood sugar level, such as dizziness and sweating, are not||
3013|175|P|affected by this drug.||
3013|176|P|   If you have diabetes, this product may make it harder to||
3013|177|P|control your blood sugar levels. Check your blood sugar levels||
3013|178|P|regularly as directed by your doctor. Tell your doctor right away||
3013|179|P|if you have symptoms of high blood sugar such as increased||
3013|180|P|thirst/urination. Your doctor may need to adjust your diabetes||
3013|181|P|medication, exercise program, or diet.||
3013|182|P|   Children may be at greater risk for low blood sugar||
3013|183|P|(hypoglycemia) while using this drug, especially if they are||
3013|184|P|vomiting or not eating regularly. To help prevent low blood||
3013|185|P|sugar, make sure children eat regularly. If your child cannot eat||
3013|186|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
3013|187|P|as sweating, shaking), tell the doctor right away.||
3013|188|P|   Older adults may be more sensitive to the side effects of this||
3013|189|P|drug, especially dizziness, tiredness, and QT prolongation (see||
3013|190|P|above).||
3013|191|P|   During pregnancy, this medication should be used only when||
3013|192|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
3013|193|P|benefits with your doctor.||
3013|194|P|   This medication passes into breast milk and may have||
3013|195|P|undesirable effects on a nursing infant. Consult your doctor||
3013|196|P|before breastfeeding.||
3013|197|B|||
3013|198|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
3013|199|I|   Drug interactions may change how your medications work or||
3013|200|I|increase your risk for serious side effects. This document does||
3013|201|I|not contain all possible drug interactions. Keep a list of all||
3013|202|I|the products you use (including prescription/nonprescription||
3013|203|I|drugs and herbal products) and share it with your doctor and||
3013|204|I|pharmacist. Do not start, stop, or change the dosage of any||
3013|205|I|medicines without your doctor's approval.||
3013|206|I|   A product that may interact with this drug is: fingolimod.||
3013|207|I|   Many drugs besides sotalol may affect the heart rhythm (QT||
3013|208|I|prolongation in the EKG), including amiodarone, disopyramide,||
3013|209|I|dofetilide, pimozide, procainamide, quinidine, macrolide||
3013|210|I|antibiotics (such as clarithromycin, erythromycin), among others.||
3013|211|I|   Some products have ingredients that could raise your heart||
3013|212|I|rate. Tell your pharmacist what products you are using, and ask||
3013|213|I|how to use them safely (especially cough-and-cold products, diet||
3013|214|I|aids, or NSAIDs such as ibuprofen/naproxen).||
3013|215|I|   This medication may interfere with certain medical/lab tests,||
3013|216|I|possibly causing false test results. Make sure lab personnel and||
3013|217|I|all your doctors know you use this drug.||
3013|218|B|||
3013|219|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3013|220|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3013|221|O|poison control center right away. US residents can call||
3013|222|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3013|223|O|Symptoms of overdose may include: severe dizziness, fainting,||
3013|224|O|unusually slower/faster/more irregular heartbeat, shortness of||
3013|225|O|breath.||
3013|226|B|||
3013|227|N|NOTES:  Do not share this medication with others.||
3013|228|N|   Lab and/or medical tests (such as EKG, kidney function) should||
3013|229|N|be done while you are taking this medication. Keep all medical||
3013|230|N|and lab appointments. Consult your doctor for more details.||
3013|231|B|||
3013|232|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
3013|233|D|next dose at the regular time. Do not double the dose to catch||
3013|234|D|up.||
3013|235|B|||
3013|236|R|STORAGE:  Store at room temperature away from light and moisture.||
3013|237|R|Do not store in the bathroom. Keep all medications away from||
3013|238|R|children and pets.||
3013|239|R|   Do not flush medications down the toilet or pour them into a||
3013|240|R|drain unless instructed to do so. Properly discard this product||
3013|241|R|when it is expired or no longer needed. Consult your pharmacist||
3013|242|R|or local waste disposal company.||
3013|243|B|||
3013|244|M|MEDICAL ALERT:  Your condition can cause complications in a||
3013|245|M|medical emergency. For information about enrolling in MedicAlert,||
3013|246|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3013|247|B|||
3013|248|A|Information last revised October 2024.||
3013|249|A|Copyright(c) 2025 First Databank, Inc.||
3013|250|B|||
3015|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3015|002|Z|does NOT have all possible information about this product. This||
3015|003|Z|information does not assure that this product is safe, effective,||
3015|004|Z|or appropriate for you. This information is not individual||
3015|005|Z|medical advice and does not substitute for the advice of your||
3015|006|Z|health care professional. Always ask your health care||
3015|007|Z|professional for complete information about this product and your||
3015|008|Z|specific health needs.||
3015|009|B|||
3015|010|T|ERYTHROMYCIN ETHYLSUCCINATE LIQUID - ORAL||
3015|011|F|(e-RITH-roe-MYE-sin ETH-il-SUX-i-nate)||
3015|012|B|||
3015|013|C|COMMON BRAND NAME(S): E.E.S., Eryped||
3015|014|B|||
3015|015|U|USES:  Erythromycin is used to treat a wide variety of bacterial||
3015|016|U|infections. It may also be used to prevent certain bacterial||
3015|017|U|infections. Erythromycin is known as a macrolide antibiotic. It||
3015|018|U|works by stopping the growth of bacteria.||
3015|019|U|   This antibiotic treats or prevents only bacterial infections.||
3015|020|U|It will not work for viral infections (such as common cold, flu).||
3015|021|U|Using any antibiotic when it is not needed can cause it to not||
3015|022|U|work for future infections.||
3015|023|B|||
3015|024|V|OTHER USES:  This section contains uses of this drug that are not||
3015|025|V|listed in the approved professional labeling for the drug but||
3015|026|V|that may be prescribed by your health care professional. Use this||
3015|027|V|drug for a condition that is listed in this section only if it||
3015|028|V|has been so prescribed by your health care professional.||
3015|029|V|   This drug may also be used for a certain type of stomach||
3015|030|V|condition involving slowed digestion (gastroparesis).||
3015|031|B|||
3015|032|H|HOW TO USE:  Take this medication by mouth with or without food||
3015|033|H|as directed by your doctor. If nausea occurs, taking this||
3015|034|H|medication with food or milk may reduce this side effect.||
3015|035|H|   Shake the bottle well before each dose. Carefully measure the||
3015|036|H|dose using a special measuring device/spoon. Do not use a||
3015|037|H|household spoon because you may not get the correct dose.||
3015|038|H|   The dosage and length of treatment are based on your medical||
3015|039|H|condition and response to treatment. Children's dosage is also||
3015|040|H|based on age and weight.||
3015|041|H|   For the best effect, take this antibiotic at evenly spaced||
3015|042|H|times. To help you remember, take this medication at the same||
3015|043|H|time(s) every day.||
3015|044|H|   If you are using this medication to treat an infection,||
3015|045|H|continue to take this medication until the full prescribed amount||
3015|046|H|is finished, even if symptoms disappear after a few days.||
3015|047|H|Stopping the medication too early may result in a return of the||
3015|048|H|infection. Tell your doctor if your condition lasts or gets||
3015|049|H|worse.||
3015|050|H|   If you are taking this medication to prevent certain bacterial||
3015|051|H|infections, take it exactly as directed by your doctor. Do not||
3015|052|H|stop taking the medication without your doctor's approval.||
3015|053|B|||
3015|054|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach pain/cramping,||
3015|055|S|and loss of appetite may occur. Taking this medication with food||
3015|056|S|may lessen these symptoms. If any of these effects last or get||
3015|057|S|worse, tell your doctor or pharmacist promptly.||
3015|058|S|   Remember that this medication has been prescribed because your||
3015|059|S|doctor has judged that the benefit to you is greater than the||
3015|060|S|risk of side effects. Many people using this medication do not||
3015|061|S|have serious side effects.||
3015|062|S|   Tell your doctor right away if you have any serious side||
3015|063|S|effects, including: signs of liver disease (such as||
3015|064|S|nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
3015|065|S|urine, severe stomach/abdominal pain), unusual tiredness, muscle||
3015|066|S|weakness, trouble speaking, blurred vision, drooping eyelids,||
3015|067|S|hearing loss.||
3015|068|S|   Get medical help right away if you have any very serious side||
3015|069|S|effects, including: severe dizziness, fainting, fast/irregular||
3015|070|S|heartbeat.||
3015|071|S|   This medication may rarely cause a severe intestinal condition||
3015|072|S|due to a bacteria called C. difficile. This condition may occur||
3015|073|S|during treatment or weeks to months after treatment has stopped.||
3015|074|S|Tell your doctor right away if you develop: diarrhea that doesn't||
3015|075|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
3015|076|S|stool.||
3015|077|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
3015|078|S|products because they may make symptoms worse.||
3015|079|S|   Use of this medication for prolonged or repeated periods may||
3015|080|S|result in oral thrush or a new yeast infection. Contact your||
3015|081|S|doctor if you notice white patches in your mouth, a change in||
3015|082|S|vaginal discharge or other new symptoms.||
3015|083|S|   A very serious allergic reaction to this drug is rare.||
3015|084|S|However, get medical help right away if you notice any symptoms||
3015|085|S|of a serious allergic reaction, including: rash, itching/swelling||
3015|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3015|087|S|breathing.||
3015|088|S|   This is not a complete list of possible side effects. If you||
3015|089|S|notice other effects not listed above, contact your doctor or||
3015|090|S|pharmacist.||
3015|091|S|   In the US -||
3015|092|S|   Call your doctor for medical advice about side effects. You||
3015|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3015|094|S|www.fda.gov/medwatch.||
3015|095|S|   In Canada - Call your doctor for medical advice about side||
3015|096|S|effects. You may report side effects to Health Canada at||
3015|097|S|1-866-234-2345.||
3015|098|B|||
3015|099|P|PRECAUTIONS:  Before taking erythromycin, tell your doctor or||
3015|100|P|pharmacist if you are allergic to it; or to other macrolide||
3015|101|P|antibiotics (such as azithromycin, clarithromycin); or if you||
3015|102|P|have any other allergies. This product may contain inactive||
3015|103|P|ingredients, which can cause allergic reactions or other||
3015|104|P|problems. Talk to your pharmacist for more details.||
3015|105|P|   Before using this medication, tell your doctor or pharmacist||
3015|106|P|your medical history, especially of: kidney disease, liver||
3015|107|P|disease, a certain type of muscle disease (myasthenia gravis).||
3015|108|P|   Erythromycin may cause a condition that affects the heart||
3015|109|P|rhythm (QT prolongation). QT prolongation can rarely cause||
3015|110|P|serious (rarely fatal) fast/irregular heartbeat and other||
3015|111|P|symptoms (such as severe dizziness, fainting) that need medical||
3015|112|P|attention right away.||
3015|113|P|   The risk of QT prolongation may be increased if you have||
3015|114|P|certain medical conditions or are taking other drugs that may||
3015|115|P|cause QT prolongation. Before using erythromycin, tell your||
3015|116|P|doctor or pharmacist of all the drugs you take and if you have||
3015|117|P|any of the following conditions: certain heart problems (heart||
3015|118|P|failure, slow heartbeat, QT prolongation in the EKG), family||
3015|119|P|history of certain heart problems (QT prolongation in the EKG,||
3015|120|P|sudden cardiac death).||
3015|121|P|   Low levels of potassium or magnesium in the blood may also||
3015|122|P|increase your risk of QT prolongation. This risk may increase if||
3015|123|P|you use certain drugs (such as diuretics/"water pills") or if you||
3015|124|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3015|125|P|Talk to your doctor about using erythromycin safely.||
3015|126|P|   Erythromycin may cause live bacterial vaccines (such as||
3015|127|P|typhoid vaccine) to not work well. Tell your health care||
3015|128|P|professional that you are using erythromycin before having any||
3015|129|P|immunizations/vaccinations.||
3015|130|P|   Before having surgery, tell your doctor or dentist about all||
3015|131|P|the products you use (including prescription drugs,||
3015|132|P|nonprescription drugs, and herbal products).||
3015|133|P|   Some erythromycin products may contain sodium. Ask your doctor||
3015|134|P|or pharmacist for more information if you are on a||
3015|135|P|salt-restricted diet or if you have a condition that could be||
3015|136|P|worsened by an increase in salt intake (such as heart failure).||
3015|137|P|   Older adults may be more sensitive to the side effects of this||
3015|138|P|drug, especially hearing loss and QT prolongation (see above).||
3015|139|P|   Babies may be at higher risk for a certain serious stomach||
3015|140|P|problem. Contact your child's doctor right away if your child||
3015|141|P|vomits or becomes irritable with feeding.||
3015|142|P|   Tell your doctor if you are pregnant before using this||
3015|143|P|medication.||
3015|144|P|   This medication passes into breast milk. Consult your doctor||
3015|145|P|before breastfeeding.||
3015|146|B|||
3015|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3015|148|I|medications work or increase your risk for serious side effects.||
3015|149|I|This document does not contain all possible drug interactions.||
3015|150|I|Keep a list of all the products you use (including||
3015|151|I|prescription/nonprescription drugs and herbal products) and share||
3015|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
3015|153|I|the dosage of any medicines without your doctor's approval.||
3015|154|I|   A product that may interact with this drug is: digoxin.||
3015|155|I|   Many drugs besides erythromycin may affect the heart rhythm||
3015|156|I|(QT prolongation), including amiodarone, dofetilide, pimozide,||
3015|157|I|procainamide, propafenone, quinidine, sotalol, among others.||
3015|158|I|   Other medications can affect the removal of erythromycin from||
3015|159|I|your body, which may affect how erythromycin works. Examples||
3015|160|I|include azole antifungals (such as itraconazole, ketoconazole),||
3015|161|I|certain calcium channel blockers (such as diltiazem, verapamil),||
3015|162|I|certain anti-seizure medications (such as carbamazepine,||
3015|163|I|phenytoin), among others.||
3015|164|I|   Erythromycin can slow down the removal of other drugs from||
3015|165|I|your body, which may affect how they work. Examples of affected||
3015|166|I|drugs include bromocriptine, colchicine, certain benzodiazepines||
3015|167|I|(such as midazolam, triazolam), eletriptan, ergot alkaloids (such||
3015|168|I|as ergotamine, dihydroergotamine), certain drugs to treat||
3015|169|I|erectile dysfunction-ED or pulmonary hypertension (such as||
3015|170|I|sildenafil, tadalafil), certain "statin" drugs (such as||
3015|171|I|lovastatin, simvastatin), vinblastine, among others.||
3015|172|I|   This medication may interfere with certain lab tests (such as||
3015|173|I|urine tests), possibly causing false test results. Make sure lab||
3015|174|I|personnel and all your doctors know you use this drug.||
3015|175|B|||
3015|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3015|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3015|178|O|poison control center right away. US residents can call||
3015|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3015|180|B|||
3015|181|N|NOTES:  Do not share this medication with others.||
3015|182|N|   This medication has been prescribed for your current condition||
3015|183|N|only. Do not use it later for another infection unless your||
3015|184|N|doctor tells you to.||
3015|185|B|||
3015|186|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3015|187|D|remember. If it is near the time of the next dose, skip the||
3015|188|D|missed dose. Take your next dose at the regular time. Do not||
3015|189|D|double the dose to catch up.||
3015|190|B|||
3015|191|R|STORAGE:  Different brands of this medication have different||
3015|192|R|storage needs. Check the product package for instructions on how||
3015|193|R|to store your brand, or ask your pharmacist. Do not freeze or||
3015|194|R|store in the bathroom. Keep all medications away from children||
3015|195|R|and pets.||
3015|196|R|   Do not flush medications down the toilet or pour them into a||
3015|197|R|drain unless instructed to do so. Properly discard this product||
3015|198|R|when it is expired or no longer needed. Consult your pharmacist||
3015|199|R|or local waste disposal company.||
3015|200|B|||
3015|201|A|Information last revised May 2025.||
3015|202|A|Copyright(c) 2025 First Databank, Inc.||
3015|203|B|||
3019|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3019|002|Z|does NOT have all possible information about this product. This||
3019|003|Z|information does not assure that this product is safe, effective,||
3019|004|Z|or appropriate for you. This information is not individual||
3019|005|Z|medical advice and does not substitute for the advice of your||
3019|006|Z|health care professional. Always ask your health care||
3019|007|Z|professional for complete information about this product and your||
3019|008|Z|specific health needs.||
3019|009|B|||
3019|010|T|TOPIRAMATE SPRINKLES - ORAL||
3019|011|F|(toe-PEER-uh-mate)||
3019|012|B|||
3019|013|C|COMMON BRAND NAME(S): Topamax||
3019|014|B|||
3019|015|U|USES:  Topiramate is used alone or with other medications to||
3019|016|U|prevent and control seizures (epilepsy). This medication is also||
3019|017|U|used to prevent migraine headaches and decrease how often you get||
3019|018|U|them. Topiramate will not treat a migraine headache once it||
3019|019|U|occurs. If you get a migraine headache, treat it as directed by||
3019|020|U|your doctor (such as by taking pain medication, lying down in a||
3019|021|U|dark room).||
3019|022|U|   Topiramate is known as an anticonvulsant or antiepileptic||
3019|023|U|drug.||
3019|024|B|||
3019|025|V|OTHER USES:  This section contains uses of this drug that are not||
3019|026|V|listed in the approved professional labeling for the drug but||
3019|027|V|that may be prescribed by your health care professional. Use this||
3019|028|V|drug for a condition that is listed in this section only if it||
3019|029|V|has been so prescribed by your health care professional.||
3019|030|V|   This drug may also be used for binge eating disorder (BED).||
3019|031|B|||
3019|032|H|HOW TO USE:  Read the Medication Guide and, if available, the||
3019|033|H|Patient Information Leaflet provided by your pharmacist before||
3019|034|H|you start taking topiramate and each time you get a refill. If||
3019|035|H|you have any questions, ask your doctor or pharmacist.||
3019|036|H|   Take this medication by mouth with or without food as directed||
3019|037|H|by your doctor, usually twice daily. You may swallow this||
3019|038|H|medication whole, or you may open the capsule and sprinkle the||
3019|039|H|contents on a teaspoonful of soft food (such as applesauce,||
3019|040|H|yogurt). Swallow the drug/food mixture right away. Do not chew||
3019|041|H|the mixture. Do not prepare the mixture ahead of time for later||
3019|042|H|use. Drink some liquid after swallowing the mixture to make sure||
3019|043|H|all of the drug is swallowed.||
3019|044|H|   To prevent kidney stones from forming, drink plenty of liquids||
3019|045|H|while taking this medication unless your doctor instructs you||
3019|046|H|otherwise.||
3019|047|H|   The dosage is based on your medical condition and response to||
3019|048|H|treatment. Children's dosage is also based on weight. Your doctor||
3019|049|H|will gradually increase your dose to reduce your risk of side||
3019|050|H|effects. For some conditions, you may start treatment with||
3019|051|H|topiramate once daily at bedtime and slowly increase your dose to||
3019|052|H|twice a day. It may take several weeks or months to reach the||
3019|053|H|best dose for you and to get the full benefit from this||
3019|054|H|medication.||
3019|055|H|   Take this medication regularly to get the most benefit from||
3019|056|H|it. To help you remember, take it at the same times each day. Do||
3019|057|H|not stop taking this medication without consulting your doctor.||
3019|058|H|Some conditions may become worse when this drug is suddenly||
3019|059|H|stopped. Your dose may need to be gradually decreased.||
3019|060|H|   Tell your doctor if your condition lasts or if it gets worse.||
3019|061|B|||
3019|062|S|SIDE EFFECTS:  Tiredness, drowsiness, dizziness, loss of||
3019|063|S|coordination, nervousness, tingling of the hands/feet, loss of||
3019|064|S|appetite, changes in how foods taste, diarrhea, or weight loss||
3019|065|S|may occur. If any of these effects last or get worse, tell your||
3019|066|S|doctor or pharmacist promptly.||
3019|067|S|   Remember that this medication has been prescribed because your||
3019|068|S|doctor has judged that the benefit to you is greater than the||
3019|069|S|risk of side effects. Many people using this medication do not||
3019|070|S|have serious side effects.||
3019|071|S|   Tell your doctor right away if you have any serious side||
3019|072|S|effects, including: bone pain, signs of kidney stones (such as||
3019|073|S|severe back/side/abdominal/groin pain, fever, chills,||
3019|074|S|painful/frequent urination, bloody/pink urine), unusual||
3019|075|S|bleeding/bruising, confusion, difficulty concentrating, memory||
3019|076|S|loss, difficulty speaking.||
3019|077|S|   Get medical help right away if you have any very serious side||
3019|078|S|effects, including: rapid breathing, fast/slow/irregular||
3019|079|S|heartbeat.||
3019|080|S|   A small number of people who take anticonvulsants for any||
3019|081|S|condition (such as seizures, bipolar disorder, pain) may||
3019|082|S|experience depression, suicidal thoughts/attempts, or other||
3019|083|S|mental/mood problems. Tell your doctor right away if you or your||
3019|084|S|family/caregiver notice any unusual/sudden changes in your mood,||
3019|085|S|thoughts, or behavior including signs of depression, suicidal||
3019|086|S|thoughts/attempts, thoughts about harming yourself.||
3019|087|S|   Rarely, topiramate may cause a very serious eye problem,||
3019|088|S|usually within 1 month of starting treatment. This eye problem||
3019|089|S|can lead to permanent blindness. Get medical help right away if||
3019|090|S|any of these side effects occur: sudden vision changes (such as||
3019|091|S|decreased vision, blurred vision), eye pain/redness.||
3019|092|S|   This medication can rarely cause a serious metabolic problem||
3019|093|S|(high amount of ammonia in the blood), especially if you are also||
3019|094|S|taking valproic acid. Tell your doctor right away if you||
3019|095|S|experience sudden/unexplained tiredness, vomiting, or mental||
3019|096|S|changes (such as decreased alertness).||
3019|097|S|   A very serious allergic reaction to this drug is rare.||
3019|098|S|However, get medical help right away if you notice any symptoms||
3019|099|S|of a serious allergic reaction, including: rash, itching/swelling||
3019|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3019|101|S|breathing.||
3019|102|S|   This is not a complete list of possible side effects. If you||
3019|103|S|notice other effects not listed above, contact your doctor or||
3019|104|S|pharmacist.||
3019|105|S|   In the US -||
3019|106|S|   Call your doctor for medical advice about side effects. You||
3019|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3019|108|S|www.fda.gov/medwatch.||
3019|109|S|   In Canada - Call your doctor for medical advice about side||
3019|110|S|effects. You may report side effects to Health Canada at||
3019|111|S|1-866-234-2345.||
3019|112|B|||
3019|113|P|PRECAUTIONS:  Before taking topiramate, tell your doctor or||
3019|114|P|pharmacist if you are allergic to it; or if you have any other||
3019|115|P|allergies. This product may contain inactive ingredients, which||
3019|116|P|can cause allergic reactions or other problems. Talk to your||
3019|117|P|pharmacist for more details.||
3019|118|P|   Before using this medication, tell your doctor or pharmacist||
3019|119|P|your medical history, especially of: a certain eye problem||
3019|120|P|(narrow angle glaucoma), kidney problems (such as kidney stones),||
3019|121|P|liver problems, mental/mood problems (such as depression,||
3019|122|P|thoughts of suicide), lung/breathing problems, a certain||
3019|123|P|metabolic imbalance (metabolic acidosis), long-term diarrhea, a||
3019|124|P|diet high in fat and low in carbohydrates (ketogenic diet),||
3019|125|P|brittle bones (osteoporosis).||
3019|126|P|   This drug may make you dizzy or drowsy or impair your||
3019|127|P|judgment. Alcohol or marijuana (cannabis) can worsen these||
3019|128|P|effects. Do not drive, use machinery, or do anything that needs||
3019|129|P|alertness until you can do it safely. Avoid alcoholic beverages.||
3019|130|P|Talk to your doctor if you are using marijuana (cannabis).||
3019|131|P|   This medication may make you sweat less, making you more||
3019|132|P|likely to get heat stroke. Avoid doing things that may cause you||
3019|133|P|to overheat, such as hard work or exercise in hot weather, or||
3019|134|P|using hot tubs. When the weather is hot, drink a lot of fluids||
3019|135|P|and dress lightly. If you overheat, quickly look for a place to||
3019|136|P|cool down and rest. Get medical help right away if you have a||
3019|137|P|fever that does not go away, mental/mood changes, headache, or||
3019|138|P|dizziness.||
3019|139|P|   Before having surgery, tell your doctor or dentist about all||
3019|140|P|the products you use (including prescription drugs,||
3019|141|P|nonprescription drugs, and herbal products).||
3019|142|P|   Children may be more sensitive to the side effects of this||
3019|143|P|drug, especially weakened bones, slowed growth rate, and||
3019|144|P|decreased sweating. Consult your doctor or pharmacist for more||
3019|145|P|details.||
3019|146|P|   Older adults may be more sensitive to the side effects of this||
3019|147|P|drug, especially dizziness. Dizziness can increase the risk of||
3019|148|P|falling.||
3019|149|P|   During pregnancy, this medication should be used only when||
3019|150|P|clearly needed. It may harm an unborn baby. Discuss the use of||
3019|151|P|reliable forms of birth control with your doctor (see also Drug||
3019|152|P|Interactions section). If you are planning pregnancy, become||
3019|153|P|pregnant, or think you may be pregnant, immediately talk to your||
3019|154|P|doctor about the benefits and risks of using this medication||
3019|155|P|during pregnancy. If you are taking this drug to treat seizures,||
3019|156|P|note that untreated seizures are a serious condition that can||
3019|157|P|harm both a pregnant woman and her unborn baby, so do not stop||
3019|158|P|taking this medication unless directed by your doctor.||
3019|159|P|   This medication passes into breast milk and may have||
3019|160|P|undesirable effects on a nursing infant. Consult your doctor||
3019|161|P|before breastfeeding.||
3019|162|B|||
3019|163|I|DRUG INTERACTIONS:  See also Side Effects section.||
3019|164|I|   Drug interactions may change how your medications work or||
3019|165|I|increase your risk for serious side effects. This document does||
3019|166|I|not contain all possible drug interactions. Keep a list of all||
3019|167|I|the products you use (including prescription/nonprescription||
3019|168|I|drugs and herbal products) and share it with your doctor and||
3019|169|I|pharmacist. Do not start, stop, or change the dosage of any||
3019|170|I|medicines without your doctor's approval.||
3019|171|I|   A product that may interact with this drug is: orlistat.||
3019|172|I|   This medication may decrease the effectiveness of hormonal||
3019|173|I|birth control such as pills, patch, or ring. This could cause||
3019|174|I|pregnancy. Discuss with your doctor or pharmacist if you should||
3019|175|I|use reliable backup birth control methods while using this||
3019|176|I|medication. Also tell your doctor if you have any new spotting or||
3019|177|I|breakthrough bleeding, because these may be signs that your birth||
3019|178|I|control is not working well.||
3019|179|I|   Tell your doctor or pharmacist if you are taking other||
3019|180|I|products that cause drowsiness including alcohol, marijuana||
3019|181|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
3019|182|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
3019|183|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
3019|184|I|codeine).||
3019|185|I|   Check the labels on all your medicines (such as allergy or||
3019|186|I|cough-and-cold products) because they may contain ingredients||
3019|187|I|that cause drowsiness. Ask your pharmacist about using those||
3019|188|I|products safely.||
3019|189|B|||
3019|190|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3019|191|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3019|192|O|poison control center right away. US residents can call||
3019|193|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3019|194|O|Symptoms of overdose may include: severe drowsiness, loss of||
3019|195|O|consciousness.||
3019|196|B|||
3019|197|N|NOTES:  Do not share this medication with others.||
3019|198|N|   Lab and/or medical tests (such as eye exams, bicarbonate blood||
3019|199|N|level) should be done while you are taking this medication. Keep||
3019|200|N|all medical and lab appointments.||
3019|201|B|||
3019|202|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3019|203|D|remember. If it is within 6 hours of the next dose, skip the||
3019|204|D|missed dose. Take your next dose at the regular time. Do not||
3019|205|D|double the dose to catch up. If you miss more than one dose, call||
3019|206|D|your doctor for advice.||
3019|207|B|||
3019|208|R|STORAGE:  Store at room temperature away from light and moisture.||
3019|209|R|Do not store in the bathroom. Keep all medications away from||
3019|210|R|children and pets.||
3019|211|R|   Do not flush medications down the toilet or pour them into a||
3019|212|R|drain unless instructed to do so. Properly discard this product||
3019|213|R|when it is expired or no longer needed. Consult your pharmacist||
3019|214|R|or local waste disposal company.||
3019|215|B|||
3019|216|M|MEDICAL ALERT:  Your condition can cause complications in a||
3019|217|M|medical emergency. For information about enrolling in MedicAlert,||
3019|218|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3019|219|B|||
3019|220|A|Information last revised September 2024.||
3019|221|A|Copyright(c) 2025 First Databank, Inc.||
3019|222|B|||
3021|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3021|002|Z|does NOT have all possible information about this product. This||
3021|003|Z|information does not assure that this product is safe, effective,||
3021|004|Z|or appropriate for you. This information is not individual||
3021|005|Z|medical advice and does not substitute for the advice of your||
3021|006|Z|health care professional. Always ask your health care||
3021|007|Z|professional for complete information about this product and your||
3021|008|Z|specific health needs.||
3021|009|B|||
3021|010|T|HYDROCORTISONE SUPPOSITORY - RECTAL||
3021|011|F|(HYE-droe-KOR-ti-sone)||
3021|012|B|||
3021|013|C|COMMON BRAND NAME(S): Anucort-HC, Anusol-HC, Cort-Dome||
3021|014|B|||
3021|015|U|USES:  This medication is used to treat hemorrhoids and||
3021|016|U|itching/swelling in the rectum and anus. It is also used with||
3021|017|U|other medications to treat certain intestinal problems (such as||
3021|018|U|ulcerative colitis of the rectum and other rectal/anal||
3021|019|U|inflammatory conditions). Hydrocortisone suppositories help to||
3021|020|U|relieve rectal pain, itching, bloody diarrhea, and bleeding by||
3021|021|U|reducing swelling (inflammation) directly in the rectum and anus.||
3021|022|U|Hydrocortisone belongs to a class of drugs called||
3021|023|U|corticosteroids.||
3021|024|B|||
3021|025|H|HOW TO USE:  Use this product in the rectum as directed by your||
3021|026|H|doctor, usually 2 or 3 times daily. The dosage and length of||
3021|027|H|treatment are based on your medical condition and response to||
3021|028|H|treatment.||
3021|029|H|   Avoid handling the suppository for too long because it will||
3021|030|H|melt. Unwrap the suppository. You may moisten the tip with a few||
3021|031|H|drops of water. Lie down on your left side with your right knee||
3021|032|H|bent. Gently push the suppository, pointed end first, into the||
3021|033|H|rectum with your finger, deep enough so it does not slide back||
3021|034|H|out. Remain lying down for a few minutes. Avoid having a bowel||
3021|035|H|movement for at least 1 hour so the medication will have time to||
3021|036|H|work.||
3021|037|H|   Wash your hands after each use. Note that this medication may||
3021|038|H|stain fabric.||
3021|039|H|   Use this medication regularly as prescribed to get the most||
3021|040|H|benefit from it. Do not use more of this product, use it more||
3021|041|H|often, or use it for longer than prescribed. Your condition will||
3021|042|H|not improve any faster, and your risk of side effects may||
3021|043|H|increase. If you have been using this medication for a long time,||
3021|044|H|do not stop using it without consulting your doctor. Some||
3021|045|H|conditions may become worse when the drug is suddenly stopped.||
3021|046|H|Your dose may need to be gradually decreased.||
3021|047|H|   Tell your doctor if your condition does not get better after||
3021|048|H|your prescribed length of treatment or if it gets worse.||
3021|049|B|||
3021|050|S|SIDE EFFECTS:  Burning, itching, dryness, skin/hair follicle||
3021|051|S|irritation, and changes in skin color around the rectal area may||
3021|052|S|occur. If any of these effects last or get worse, tell your||
3021|053|S|doctor or pharmacist promptly.||
3021|054|S|   Remember that this medication has been prescribed because your||
3021|055|S|doctor has judged that the benefit to you is greater than the||
3021|056|S|risk of side effects. Many people using this medication do not||
3021|057|S|have serious side effects.||
3021|058|S|   Tell your doctor right away if you have any serious side||
3021|059|S|effects, including: rectal bleeding that is new or doesn't stop,||
3021|060|S|unusual bruising/bleeding, symptoms of stomach/intestinal||
3021|061|S|bleeding (such as stomach/abdominal pain, black/tarry stools,||
3021|062|S|vomit that looks like coffee grounds), bone pain, easily broken||
3021|063|S|bones, mental/mood changes (such as depression, mood swings,||
3021|064|S|agitation), muscle weakness/pain, irregular heartbeat, signs of||
3021|065|S|infection (such as sore throat that doesn't go away, fever,||
3021|066|S|chills, painful urination, worsening redness/irritation near the||
3021|067|S|anus).||
3021|068|S|   Rarely, it is possible this medication will be absorbed into||
3021|069|S|the bloodstream. This can lead to side effects of too much||
3021|070|S|corticosteroid. These side effects are more likely in children||
3021|071|S|and people who use this medication for a long time. Tell your||
3021|072|S|doctor right away if any of the following side effects occur:||
3021|073|S|unusual/extreme tiredness, weight loss, headache, swelling||
3021|074|S|ankles/feet, increased thirst/urination, vision problems.||
3021|075|S|   A very serious allergic reaction to this drug is rare.||
3021|076|S|However, get medical help right away if you notice any symptoms||
3021|077|S|of a serious allergic reaction, including: rash, itching/swelling||
3021|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3021|079|S|breathing.||
3021|080|S|   This is not a complete list of possible side effects. If you||
3021|081|S|notice other effects not listed above, contact your doctor or||
3021|082|S|pharmacist.||
3021|083|S|   In the US -||
3021|084|S|   Call your doctor for medical advice about side effects. You||
3021|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3021|086|S|www.fda.gov/medwatch.||
3021|087|S|   In Canada - Call your doctor for medical advice about side||
3021|088|S|effects. You may report side effects to Health Canada at||
3021|089|S|1-866-234-2345.||
3021|090|B|||
3021|091|P|PRECAUTIONS:  Before using hydrocortisone, tell your doctor or||
3021|092|P|pharmacist if you are allergic to it; or to other corticosteroids||
3021|093|P|(such as prednisone); or if you have any other allergies. This||
3021|094|P|product may contain inactive ingredients, which can cause||
3021|095|P|allergic reactions or other problems. Talk to your pharmacist for||
3021|096|P|more details.||
3021|097|P|   Before using this medication, tell your doctor or pharmacist||
3021|098|P|your medical history, especially of: other stomach/intestinal||
3021|099|P|problems (such as ulcers, blockage, bleeding, infection, recent||
3021|100|P|surgery), infections (such as tuberculosis, fungal infections),||
3021|101|P|certain eye conditions (cataracts, glaucoma, herpes infection of||
3021|102|P|the eye), heart problems (such as heart failure, recent heart||
3021|103|P|attack), high blood pressure, liver disease, kidney disease,||
3021|104|P|thyroid problems (overactive or underactive thyroid disease),||
3021|105|P|diabetes, bone loss (osteoporosis), bleeding or blood clotting||
3021|106|P|problems, mental/mood conditions (such as psychosis, depression),||
3021|107|P|low potassium blood level.||
3021|108|P|   Limit alcoholic beverages while using this medication to||
3021|109|P|decrease the risk of stomach/intestinal bleeding.||
3021|110|P|   Rarely, using corticosteroid medications for a long time can||
3021|111|P|make it more difficult for your body to respond to physical||
3021|112|P|stress. Before having surgery or emergency treatment, or if you||
3021|113|P|get a serious illness/injury, tell your doctor or dentist that||
3021|114|P|you are using this medication or have used this medication within||
3021|115|P|the past few months.||
3021|116|P|   Tell your health care professional that you are using||
3021|117|P|hydrocortisone before having any immunizations, vaccinations, or||
3021|118|P|skin tests. Avoid contact with people who have recently received||
3021|119|P|live vaccines (such as flu vaccine inhaled through the nose).||
3021|120|P|   Rarely, this drug can make you more likely to get infections||
3021|121|P|or may make current infections worse. Stay away from anyone who||
3021|122|P|has an infection that may easily spread (such as chickenpox,||
3021|123|P|COVID-19, measles, flu). Talk to your doctor if you have been||
3021|124|P|exposed to an infection or for more details.||
3021|125|P|   Older adults may be more sensitive to the side effects of this||
3021|126|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
3021|127|P|mental/mood changes (such as confusion).||
3021|128|P|   Though it is unlikely, this medication may temporarily slow||
3021|129|P|down a child's growth if used for a long time. See the doctor||
3021|130|P|regularly so your child's height can be checked.||
3021|131|P|   During pregnancy, this medication should be used only when||
3021|132|P|clearly needed and not for prolonged periods. Other forms of||
3021|133|P|hydrocortisone (given by mouth or by injection) may harm an||
3021|134|P|unborn baby. Discuss the risks and benefits with your doctor.||
3021|135|P|   It is unknown if this drug passes into breast milk. However,||
3021|136|P|it is unlikely to harm a nursing infant. Consult your doctor||
3021|137|P|before breastfeeding.||
3021|138|B|||
3021|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3021|140|I|medications work or increase your risk for serious side effects.||
3021|141|I|This document does not contain all possible drug interactions.||
3021|142|I|Keep a list of all the products you use (including||
3021|143|I|prescription/nonprescription drugs and herbal products) and share||
3021|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
3021|145|I|the dosage of any medicines without your doctor's approval.||
3021|146|I|   Some products that may interact with this drug are:||
3021|147|I|aldesleukin, "blood thinners" (such as warfarin), desmopressin.||
3021|148|I|   Check all prescription and nonprescription medicine labels||
3021|149|I|carefully since many medications contain pain relievers/fever||
3021|150|I|reducers (including aspirin, salicylates, NSAIDs such as||
3021|151|I|ibuprofen, naproxen) that may increase your risk of bleeding when||
3021|152|I|taken with corticosteroids. However, if your doctor has told you||
3021|153|I|to take low-dose aspirin to prevent heart attack or stroke||
3021|154|I|(usually 81-162 milligrams a day), you should keep taking the||
3021|155|I|aspirin unless your doctor tells you not to. Ask your doctor or||
3021|156|I|pharmacist for more details.||
3021|157|B|||
3021|158|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3021|159|O|has overdosed and has serious symptoms such as passing out or||
3021|160|O|trouble breathing, call 911. Otherwise, call a poison control||
3021|161|O|center right away. US residents can call 1-800-222-1222. Canada||
3021|162|O|residents can call 1-844-764-7669.||
3021|163|B|||
3021|164|N|NOTES:  Do not share this medication with others.||
3021|165|N|   Lab and/or medical tests (such as rectal exams, adrenal gland||
3021|166|N|function) should be done while you are using this medication.||
3021|167|N|Keep all medical and lab appointments. Consult your doctor for||
3021|168|N|more details.||
3021|169|B|||
3021|170|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3021|171|D|If it is near the time of the next dose, skip the missed dose.||
3021|172|D|Use your next dose at the regular time. Do not double the dose to||
3021|173|D|catch up.||
3021|174|B|||
3021|175|R|STORAGE:  Store at room temperature away from heat. You may store||
3021|176|R|this medication in the refrigerator to keep it from melting. Do||
3021|177|R|not freeze. Keep all medications away from children and pets.||
3021|178|R|   Do not flush medications down the toilet or pour them into a||
3021|179|R|drain unless instructed to do so. Properly discard this product||
3021|180|R|when it is expired or no longer needed. Consult your pharmacist||
3021|181|R|or local waste disposal company.||
3021|182|B|||
3021|183|A|Information last revised May 2025.||
3021|184|A|Copyright(c) 2025 First Databank, Inc.||
3021|185|B|||
3025|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3025|002|Z|does NOT have all possible information about this product. This||
3025|003|Z|information does not assure that this product is safe, effective,||
3025|004|Z|or appropriate for you. This information is not individual||
3025|005|Z|medical advice and does not substitute for the advice of your||
3025|006|Z|health care professional. Always ask your health care||
3025|007|Z|professional for complete information about this product and your||
3025|008|Z|specific health needs.||
3025|009|B|||
3025|010|T|LOPERAMIDE LIQUID - ORAL||
3025|011|F|(low-PAIR-uh-mide)||
3025|012|B|||
3025|013|C|COMMON BRAND NAME(S): Imodium, Imodium A-D||
3025|014|B|||
3025|015|W|WARNING:  Improper use of this medication (overuse or abuse) may||
3025|016|W|cause serious harm, such as fast/irregular heartbeat or death. Do||
3025|017|W|not increase your dose, take it more often, or take it for longer||
3025|018|W|than directed. Taking loperamide with certain other medications||
3025|019|W|may also cause harm. See also Precautions, Drug Interactions, and||
3025|020|W|Overdose sections.||
3025|021|W|   This medication should not be used by children younger than 2||
3025|022|W|years due to an increased risk of side effects (such as||
3025|023|W|slow/shallow breathing, fast/irregular heartbeat).||
3025|024|B|||
3025|025|U|USES:  See also Warning section.||
3025|026|U|   This medication is used to treat sudden diarrhea (including||
3025|027|U|traveler's diarrhea). It works by slowing down the movement of||
3025|028|U|the gut. This decreases the number of bowel movements and makes||
3025|029|U|the stool less watery. Loperamide is also used to reduce the||
3025|030|U|amount of discharge in patients who have had an ileostomy. It is||
3025|031|U|also used to treat ongoing diarrhea in people with inflammatory||
3025|032|U|bowel disease.||
3025|033|U|   Loperamide treats only the symptoms, not the cause of the||
3025|034|U|diarrhea (such as infection). Treatment of other symptoms and the||
3025|035|U|cause of the diarrhea should be determined by your doctor.||
3025|036|B|||
3025|037|H|HOW TO USE:  See also Warning section.||
3025|038|H|   If you are using the over-the-counter product to self-treat,||
3025|039|H|read all the directions on the product package before taking this||
3025|040|H|medication. If your doctor has prescribed this medication, follow||
3025|041|H|your doctor's directions and the directions on your prescription||
3025|042|H|label.||
3025|043|H|   Take this medication by mouth, usually after each loose stool||
3025|044|H|or as directed by your doctor. Shake the bottle well before each||
3025|045|H|use. Measure each dose carefully using the attached measuring||
3025|046|H|cup. Do not use a household spoon since you may not get the||
3025|047|H|correct dose.||
3025|048|H|   The dosage is based on your condition and response to||
3025|049|H|treatment. Children's dosage is also based on age and weight.||
3025|050|H|Adults should not use more than 8 milligrams in 24 hours if||
3025|051|H|self-treating, or 16 milligrams in 24 hours if under a doctor's||
3025|052|H|direction.||
3025|053|H|   Diarrhea can cause dehydration. Drink plenty of fluids and||
3025|054|H|minerals (electrolytes) to replace what is lost. Tell your doctor||
3025|055|H|right away if you develop signs of dehydration (such as extreme||
3025|056|H|thirst, decreased urination, muscle cramps, weakness, fainting).||
3025|057|H|You may also need to change to a bland diet during this time to||
3025|058|H|reduce irritation to your stomach/intestines. Consult your doctor||
3025|059|H|or pharmacist for more information.||
3025|060|H|   Tell your doctor if your diarrhea does not get better after 2||
3025|061|H|days, if your condition gets worse, or if you develop new||
3025|062|H|symptoms. If you develop blood in the stool, fever, or an||
3025|063|H|uncomfortable fullness/swelling of the stomach/abdomen, or if you||
3025|064|H|think you may have a serious medical problem, get medical help||
3025|065|H|right away.||
3025|066|H|   If you are taking this medication under your doctor's||
3025|067|H|direction for ongoing diarrhea, tell your doctor if your diarrhea||
3025|068|H|continues after 10 days of treatment.||
3025|069|B|||
3025|070|S|SIDE EFFECTS:  Dizziness, drowsiness, tiredness, or constipation||
3025|071|S|may occur. If any of these effects last or get worse, tell your||
3025|072|S|doctor promptly.||
3025|073|S|   If your doctor has directed you to use this medication,||
3025|074|S|remember that your doctor has judged that the benefit to you is||
3025|075|S|greater than the risk of side effects. Many people using this||
3025|076|S|medication do not have serious side effects.||
3025|077|S|   Stop taking this medication and get medical help right away if||
3025|078|S|you have any very serious side effects, including: severe||
3025|079|S|constipation/nausea/vomiting, stomach/abdominal pain,||
3025|080|S|uncomfortable fullness of the stomach/abdomen, fast/irregular||
3025|081|S|heartbeat, severe dizziness, fainting.||
3025|082|S|   A very serious allergic reaction to this drug is rare.||
3025|083|S|However, get medical help right away if you notice any symptoms||
3025|084|S|of a serious allergic reaction, including: rash, itching/swelling||
3025|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3025|086|S|breathing.||
3025|087|S|   This is not a complete list of possible side effects. If you||
3025|088|S|notice other effects not listed above, contact your doctor or||
3025|089|S|pharmacist.||
3025|090|S|   In the US -||
3025|091|S|   Call your doctor for medical advice about side effects. You||
3025|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3025|093|S|www.fda.gov/medwatch.||
3025|094|S|   In Canada - Call your doctor for medical advice about side||
3025|095|S|effects. You may report side effects to Health Canada at||
3025|096|S|1-866-234-2345.||
3025|097|B|||
3025|098|P|PRECAUTIONS:  Before taking loperamide, tell your doctor or||
3025|099|P|pharmacist if you are allergic to it; or if you have any other||
3025|100|P|allergies. This product may contain inactive ingredients, which||
3025|101|P|can cause allergic reactions or other problems. Talk to your||
3025|102|P|pharmacist for more details.||
3025|103|P|   If you have any of the following health problems, consult your||
3025|104|P|doctor or pharmacist before using this medication:||
3025|105|P|stomach/abdominal pain without diarrhea, bowel obstruction (such||
3025|106|P|as ileus, megacolon, abdominal distention), black/tarry stool,||
3025|107|P|blood/mucus in your stool, high fever, HIV infection/AIDS, liver||
3025|108|P|problems, certain stomach/intestinal infections (such as||
3025|109|P|Salmonella, Shigella), certain type of bowel disease (acute||
3025|110|P|ulcerative colitis).||
3025|111|P|   Antibiotics may rarely cause a severe intestinal condition due||
3025|112|P|to a bacteria called C. difficile. Symptoms include: diarrhea||
3025|113|P|that doesn't stop, abdominal or stomach pain/cramping, or||
3025|114|P|blood/mucus in your stool. This condition may occur during||
3025|115|P|treatment or weeks to months after treatment has stopped. This||
3025|116|P|medication may make this condition worse. Do not use this||
3025|117|P|anti-diarrhea product, especially after recent antibiotic use, if||
3025|118|P|you have the above symptoms without talking with your doctor||
3025|119|P|first.||
3025|120|P|   Loperamide may cause a condition that affects the heart rhythm||
3025|121|P|(QT prolongation). QT prolongation can rarely cause serious||
3025|122|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
3025|123|P|as severe dizziness, fainting) that need medical attention right||
3025|124|P|away.||
3025|125|P|   The risk of QT prolongation may be increased if you have||
3025|126|P|certain medical conditions or are taking other drugs that may||
3025|127|P|cause QT prolongation. Before using loperamide, tell your doctor||
3025|128|P|or pharmacist of all the drugs you take and if you have any of||
3025|129|P|the following conditions: certain heart problems (heart failure,||
3025|130|P|slow heartbeat, QT prolongation in the EKG), family history of||
3025|131|P|certain heart problems (QT prolongation in the EKG, sudden||
3025|132|P|cardiac death).||
3025|133|P|   Low levels of potassium or magnesium in the blood may also||
3025|134|P|increase your risk of QT prolongation. This risk may increase if||
3025|135|P|you use certain drugs (such as diuretics/"water pills") or if you||
3025|136|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3025|137|P|Talk to your doctor about using loperamide safely.||
3025|138|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3025|139|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3025|140|P|machinery, or do anything that needs alertness until you can do||
3025|141|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
3025|142|P|are using marijuana (cannabis).||
3025|143|P|   Liquid forms of this product may contain sugar and/or alcohol.||
3025|144|P|Caution is advised if you have diabetes, alcohol dependence, or||
3025|145|P|liver disease. Ask your doctor or pharmacist about using this||
3025|146|P|product safely.||
3025|147|P|   Older adults may be more sensitive to the side effects of this||
3025|148|P|drug, especially QT prolongation (see above).||
3025|149|P|   Children may be more sensitive to the side effects of this||
3025|150|P|drug, especially drowsiness. Children are also at a higher risk||
3025|151|P|for dehydration. See also Warning and How to Use sections.||
3025|152|P|   During pregnancy, this medication should be used only if||
3025|153|P|clearly needed. Discuss the risks and benefits with your doctor.||
3025|154|P|   This drug passes into breast milk but is unlikely to harm a||
3025|155|P|nursing infant. Consult your doctor before breastfeeding.||
3025|156|B|||
3025|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3025|158|I|medications work or increase your risk for serious side effects.||
3025|159|I|This document does not contain all possible drug interactions.||
3025|160|I|Keep a list of all the products you use (including||
3025|161|I|prescription/nonprescription drugs and herbal products) and share||
3025|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
3025|163|I|the dosage of any medicines without your doctor's approval.||
3025|164|I|   Some products that may interact with this drug include:||
3025|165|I|pramlintide, recent/current antibiotic use, cholestyramine,||
3025|166|I|ritonavir.||
3025|167|I|   Many drugs besides loperamide may affect the heart rhythm (QT||
3025|168|I|prolongation), including amiodarone, chlorpromazine, haloperidol,||
3025|169|I|methadone, moxifloxacin, pentamidine, procainamide, quinidine,||
3025|170|I|sotalol, thioridazine, ziprasidone, among others.||
3025|171|B|||
3025|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3025|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3025|174|O|poison control center right away. US residents can call||
3025|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3025|176|O|Symptoms of overdose may include: difficult urination, slowed||
3025|177|O|breathing, deep sleep, fast/irregular heartbeat, severe||
3025|178|O|dizziness, fainting.||
3025|179|B|||
3025|180|N|NOTES:  If your doctor has prescribed this medication for you, do||
3025|181|N|not share it with others.||
3025|182|B|||
3025|183|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
3025|184|D|(not "as needed") and you miss a dose, take it as soon as you||
3025|185|D|remember. If it is near the time of the next dose, skip the||
3025|186|D|missed dose. Take your next dose at the regular time. Do not||
3025|187|D|double the dose to catch up.||
3025|188|B|||
3025|189|R|STORAGE:  Store at room temperature. Keep all medications away||
3025|190|R|from children and pets.||
3025|191|R|   Do not flush medications down the toilet or pour them into a||
3025|192|R|drain unless instructed to do so. Properly discard this product||
3025|193|R|when it is expired or no longer needed. Consult your pharmacist||
3025|194|R|or local waste disposal company.||
3025|195|B|||
3025|196|A|Information last revised November 2024.||
3025|197|A|Copyright(c) 2025 First Databank, Inc.||
3025|198|B|||
3027|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3027|002|Z|does NOT have all possible information about this product. This||
3027|003|Z|information does not assure that this product is safe, effective,||
3027|004|Z|or appropriate for you. This information is not individual||
3027|005|Z|medical advice and does not substitute for the advice of your||
3027|006|Z|health care professional. Always ask your health care||
3027|007|Z|professional for complete information about this product and your||
3027|008|Z|specific health needs.||
3027|009|B|||
3027|010|T|ESTRADIOL WEEKLY - TRANSDERMAL||
3027|011|F|(ES-tra-DYE-ol)||
3027|012|B|||
3027|013|C|COMMON BRAND NAME(S): Climara||
3027|014|B|||
3027|015|W|WARNING:  Estrogens, either used alone or with another hormone||
3027|016|W|(progestin), have rarely caused very serious side effects.||
3027|017|W|Discuss the risks and benefits of hormone treatment with your||
3027|018|W|doctor. Estrogens should not be used to prevent heart disease or||
3027|019|W|dementia.||
3027|020|W|   Estrogens can increase the risk of cancer of the uterus||
3027|021|W|(endometrial cancer). Taking a progestin as directed by your||
3027|022|W|doctor can help decrease this risk. Tell your doctor right away||
3027|023|W|if you have any unusual vaginal bleeding.||
3027|024|W|   In postmenopausal women, estrogens, taken with or without a||
3027|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
3027|026|W|stroke, dementia, and serious blood clots. When used along with a||
3027|027|W|progestin, estrogens also increase the risk of heart disease||
3027|028|W|(such as heart attacks).||
3027|029|W|   The risk for serious side effects may depend on the dose of||
3027|030|W|estrogen and the length of time it is used. This medication||
3027|031|W|should be used at the lowest effective dose and for the shortest||
3027|032|W|amount of time. Discuss the use of this medication with your||
3027|033|W|doctor and check with him/her regularly (for example, every 3 to||
3027|034|W|6 months) to see if you still need to use this medication. If you||
3027|035|W|will be using this medication long-term, you should have regular||
3027|036|W|complete physical exams (for example, once a year) as directed by||
3027|037|W|your doctor. See also Notes section.||
3027|038|B|||
3027|039|U|USES:  This medication is a hormone (estrogen). It is used by||
3027|040|U|women to help reduce symptoms of menopause (such as hot flashes,||
3027|041|U|vaginal dryness). These symptoms are caused by the body making||
3027|042|U|less estrogen. If you are using this medication to treat symptoms||
3027|043|U|only in and around the vagina, products applied directly inside||
3027|044|U|the vagina should be considered before medications that are taken||
3027|045|U|by mouth, absorbed through the skin, or injected. This medication||
3027|046|U|may also be used by women who are not able to produce enough||
3027|047|U|estrogen (for example, due to hypogonadism, primary ovarian||
3027|048|U|failure).||
3027|049|U|   Certain estrogen products may also be used by women after||
3027|050|U|menopause to prevent bone loss (osteoporosis). However, there are||
3027|051|U|other medications (such as raloxifene, bisphosphonates including||
3027|052|U|alendronate) that are also effective in preventing bone loss and||
3027|053|U|may be safer. These medications should be considered for use||
3027|054|U|before estrogen treatment.||
3027|055|B|||
3027|056|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3027|057|H|from your pharmacist before you start using this medication and||
3027|058|H|each time you get a refill. If you have any questions, ask your||
3027|059|H|doctor or pharmacist.||
3027|060|H|   Peel off the backing from the patch and apply the patch to a||
3027|061|H|clean, dry area of the lower stomach or the top of the buttocks.||
3027|062|H|Press the patch firmly in place for about 10 seconds to make sure||
3027|063|H|it stays on. Do not apply the patch on the breast or on oily,||
3027|064|H|broken, or irritated skin. Avoid applying the patch to areas of||
3027|065|H|the skin where it might be easily rubbed off (such as the||
3027|066|H|waistline). Use this medication as directed by your doctor. The||
3027|067|H|patch is usually worn for 1 week and then replaced. Follow the||
3027|068|H|dosing schedule carefully.||
3027|069|H|   The dosage is based on your medical condition and response to||
3027|070|H|treatment.||
3027|071|H|   When replacing your patch, make sure to apply the new patch to||
3027|072|H|a different area. Wait at least 1 week before applying a patch to||
3027|073|H|the same area. Fold the old patch in half with the sticky side||
3027|074|H|together and throw away in the trash away from children and pets.||
3027|075|H|Do not flush the patch down the toilet.||
3027|076|H|   If a patch falls off, reapply it to a different area. If the||
3027|077|H|patch does not stick completely, then apply a new patch and wear||
3027|078|H|it for the rest of the 7-day period. Do not wear 2 patches at the||
3027|079|H|same time.||
3027|080|H|   Use this medication regularly to get the most benefit from it.||
3027|081|H|To help you remember, change the patch on the same day each week.||
3027|082|H|Mark your calendar with a reminder.||
3027|083|H|   Tell your doctor if your condition does not get better or if||
3027|084|H|it gets worse.||
3027|085|B|||
3027|086|S|SIDE EFFECTS:  See also Warning section.||
3027|087|S|   Skin redness/irritation at the application site, abdominal||
3027|088|S|pain, nausea/vomiting, bloating, breast tenderness, headache, or||
3027|089|S|weight changes may occur. If any of these effects last or get||
3027|090|S|worse, tell your doctor or pharmacist promptly.||
3027|091|S|   Remember that this medication has been prescribed because your||
3027|092|S|doctor has judged that the benefit to you is greater than the||
3027|093|S|risk of side effects. Many people using this medication do not||
3027|094|S|have serious side effects.||
3027|095|S|   Tell your doctor right away if you have any serious side||
3027|096|S|effects, including: nausea/vomiting that doesn't stop,||
3027|097|S|mental/mood changes (such as depression, memory loss), breast||
3027|098|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
3027|099|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
3027|100|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
3027|101|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
3027|102|S|increased thirst/urination.||
3027|103|S|   This medication may rarely cause serious (sometimes fatal)||
3027|104|S|problems from blood clots (such as heart attack, stroke, blood||
3027|105|S|clots in the lungs or legs). Get medical help right away if you||
3027|106|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
3027|107|S|headaches, weakness on one side of the body, confusion, trouble||
3027|108|S|speaking, sudden vision changes, pain/swelling/warmth in the||
3027|109|S|groin/calf, shortness of breath/rapid breathing, sudden||
3027|110|S|dizziness/fainting.||
3027|111|S|   A very serious allergic reaction to this product is rare.||
3027|112|S|However, get medical help right away if you notice any symptoms||
3027|113|S|of a serious allergic reaction, including: rash, itching/swelling||
3027|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3027|115|S|breathing.||
3027|116|S|   This is not a complete list of possible side effects. If you||
3027|117|S|notice other effects not listed above, contact your doctor or||
3027|118|S|pharmacist.||
3027|119|S|   In the US -||
3027|120|S|   Call your doctor for medical advice about side effects. You||
3027|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3027|122|S|www.fda.gov/medwatch.||
3027|123|S|   In Canada - Call your doctor for medical advice about side||
3027|124|S|effects. You may report side effects to Health Canada at||
3027|125|S|1-866-234-2345.||
3027|126|B|||
3027|127|P|PRECAUTIONS:  Before using estradiol, tell your doctor or||
3027|128|P|pharmacist if you are allergic to it; or if you have any other||
3027|129|P|allergies. This product may contain inactive ingredients, which||
3027|130|P|can cause allergic reactions or other problems. Talk to your||
3027|131|P|pharmacist for more details.||
3027|132|P|   Before using this medication, tell your doctor or pharmacist||
3027|133|P|your medical history, especially of: vaginal bleeding of unknown||
3027|134|P|cause, certain cancers (such as breast cancer, cancer of the||
3027|135|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
3027|136|P|heart attack), liver disease, kidney disease, family medical||
3027|137|P|history (especially breast lumps, cancer, blood clots), family or||
3027|138|P|personal history of a certain swelling disorder (angioedema),||
3027|139|P|blood clotting disorders (such as protein C or protein S||
3027|140|P|deficiency), high blood pressure, diabetes, high||
3027|141|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
3027|142|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
3027|143|P|calcium in the blood), a certain hormone problem||
3027|144|P|(hypoparathyroidism), uterus problems (such as fibroids,||
3027|145|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
3027|146|P|headaches, a certain blood disorder (porphyria), mental/mood||
3027|147|P|disorders (such as dementia, depression).||
3027|148|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
3027|149|P|further increases your risk of stroke, blood clots, high blood||
3027|150|P|pressure, and heart attack, especially in women older than 35.||
3027|151|P|   Tell your doctor if you just had or will be having surgery, or||
3027|152|P|if you will be confined to a chair or bed for a long time (such||
3027|153|P|as a long plane flight). These conditions increase your risk of||
3027|154|P|getting blood clots, especially if you are taking an estrogen||
3027|155|P|product. You may need to stop this medication for a time or take||
3027|156|P|special precautions.||
3027|157|P|   This medication may cause blotchy, dark areas on your face and||
3027|158|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
3027|159|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
3027|160|P|wear protective clothing when outdoors.||
3027|161|P|   If you are nearsighted or wear contact lenses, you may develop||
3027|162|P|vision problems or trouble wearing your contact lenses. Contact||
3027|163|P|your eye doctor if these problems occur.||
3027|164|P|   If you are going to have an MRI test, tell testing personnel||
3027|165|P|that you are using this patch. Some patches may contain metals||
3027|166|P|that can cause serious burns during an MRI. Ask your doctor||
3027|167|P|whether you will need to remove your patch before the test and||
3027|168|P|apply a new patch afterward, and how to do so properly.||
3027|169|P|   Children may be more sensitive to the side effects of this||
3027|170|P|drug. It may affect their growth/development. Discuss the||
3027|171|P|possible effects of this medication with the doctor, and monitor||
3027|172|P|your child's growth periodically.||
3027|173|P|   This medication should not be used during pregnancy. If you||
3027|174|P|become pregnant or think you may be pregnant, tell your doctor||
3027|175|P|right away.||
3027|176|P|   This medication passes into breast milk. Consult your doctor||
3027|177|P|before breastfeeding.||
3027|178|B|||
3027|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3027|180|I|medications work or increase your risk for serious side effects.||
3027|181|I|This document does not contain all possible drug interactions.||
3027|182|I|Keep a list of all the products you use (including||
3027|183|I|prescription/nonprescription drugs and herbal products) and share||
3027|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
3027|185|I|the dosage of any medicines without your doctor's approval.||
3027|186|I|   Some products that may interact with this drug include:||
3027|187|I|aromatase inhibitors (such as anastrozole, exemestane,||
3027|188|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
3027|189|I|tamoxifen, toremifene, tranexamic acid.||
3027|190|I|   This medication may interfere with certain lab tests (such as||
3027|191|I|metyrapone test), possibly causing false test results. Make sure||
3027|192|I|lab personnel and all your doctors know you use this drug.||
3027|193|B|||
3027|194|O|OVERDOSE:  This medication patch may be harmful if chewed or||
3027|195|O|swallowed. If someone has overdosed, remove the patch if||
3027|196|O|possible. For serious symptoms such as passing out or trouble||
3027|197|O|breathing, call 911. Otherwise, call a poison control center||
3027|198|O|right away. US residents can call 1-800-222-1222. Canada||
3027|199|O|residents can call 1-844-764-7669.||
3027|200|B|||
3027|201|N|NOTES:  Do not share this medication with others.||
3027|202|N|   Regular complete physical exams which include lab and/or||
3027|203|N|medical tests (such as blood pressure, breast exam/mammogram,||
3027|204|N|pelvic exam, Pap smear) should be done while you are using this||
3027|205|N|medication. Follow your doctor's instructions for examining your||
3027|206|N|breasts, and report any lumps right away. Keep all medical and||
3027|207|N|lab appointments. Consult your doctor for more details.||
3027|208|N|   Preventing or controlling high blood pressure, high||
3027|209|N|cholesterol, and diabetes can help to reduce your chances of||
3027|210|N|heart disease and stroke. Lifestyle changes that can help to||
3027|211|N|control or prevent these diseases include reducing stress, eating||
3027|212|N|a low fat/salt diet, losing weight if overweight, exercising||
3027|213|N|regularly, and stopping smoking. Keep your mind active with||
3027|214|N|mental exercises (such as reading, solving crossword puzzles) to||
3027|215|N|help prevent dementia. Talk to your doctor about lifestyle||
3027|216|N|changes that might benefit you.||
3027|217|N|   Lifestyle changes that may help reduce hot flashes include||
3027|218|N|stopping smoking, dressing lightly or in layers,||
3027|219|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
3027|220|N|reducing stress, and exercising regularly.||
3027|221|N|   Lifestyle changes that help promote healthy bones include||
3027|222|N|increasing weight-bearing exercise, stopping smoking, limiting||
3027|223|N|alcohol, and eating well-balanced meals that contain adequate||
3027|224|N|calcium and vitamin D. Since you may also need to take calcium||
3027|225|N|and vitamin D supplements and make lifestyle changes, consult||
3027|226|N|your doctor for specific advice.||
3027|227|B|||
3027|228|D|MISSED DOSE:  If you forget to replace a patch at the scheduled||
3027|229|D|time, replace it as soon as you remember. Do not use more than||
3027|230|D|one patch at a time.||
3027|231|B|||
3027|232|R|STORAGE:  Store at room temperature. Do not remove the patch from||
3027|233|R|the pouch until ready for use. Keep all medications away from||
3027|234|R|children and pets.||
3027|235|R|   Do not flush medications down the toilet or pour them into a||
3027|236|R|drain unless instructed to do so. Properly discard this product||
3027|237|R|when it is expired or no longer needed (See How to Use section).||
3027|238|B|||
3027|239|A|Information last revised October 2024.||
3027|240|A|Copyright(c) 2025 First Databank, Inc.||
3027|241|B|||
3030|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3030|002|Z|does NOT have all possible information about this product. This||
3030|003|Z|information does not assure that this product is safe, effective,||
3030|004|Z|or appropriate for you. This information is not individual||
3030|005|Z|medical advice and does not substitute for the advice of your||
3030|006|Z|health care professional. Always ask your health care||
3030|007|Z|professional for complete information about this product and your||
3030|008|Z|specific health needs.||
3030|009|B|||
3030|010|T|BIMATOPROST SOLUTION - OPHTHALMIC||
3030|011|F|(bye-MAT-oh-prost)||
3030|012|B|||
3030|013|C|COMMON BRAND NAME(S): Lumigan||
3030|014|B|||
3030|015|U|USES:  Bimatoprost is used to treat high pressure inside the eye||
3030|016|U|due to glaucoma (open-angle type) or other eye diseases (such as||
3030|017|U|ocular hypertension). Lowering high pressure inside the eye can||
3030|018|U|help prevent blindness. This medication works by regulating the||
3030|019|U|flow of fluid within the eye to maintain a normal pressure.||
3030|020|B|||
3030|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3030|022|H|from your pharmacist before you start using bimatoprost and each||
3030|023|H|time you get a refill. If you have any questions, ask your doctor||
3030|024|H|or pharmacist.||
3030|025|H|   Use this medication in the affected eye(s) as directed by your||
3030|026|H|doctor, usually once a day in the evening. Do not use bimatoprost||
3030|027|H|more often because it will not work as well.||
3030|028|H|   To apply eye drops, wash your hands first. To avoid||
3030|029|H|contamination, do not touch the dropper tip or let it touch your||
3030|030|H|eye or any other surface.||
3030|031|H|   If you are wearing contact lenses, remove them before using||
3030|032|H|your eye drops. Wait at least 15 minutes after each dose before||
3030|033|H|putting your lenses back in.||
3030|034|H|   Tilt your head back, look upward, and pull down the lower||
3030|035|H|eyelid to make a pouch. Hold the dropper directly over your eye||
3030|036|H|and place one drop into the pouch. Look downward and gently close||
3030|037|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
3030|038|H|your eye (near the nose) and apply gentle pressure. This will||
3030|039|H|prevent the medication from draining out. Try not to blink and do||
3030|040|H|not rub your eye. Repeat these steps for your other eye if so||
3030|041|H|directed.||
3030|042|H|   Do not rinse the dropper. Replace the dropper cap after each||
3030|043|H|use, and keep the cap tightly closed.||
3030|044|H|   If you are using another kind of eye medication (such as drops||
3030|045|H|or ointments), wait at least 5 minutes before applying other||
3030|046|H|medications. Use eye drops before eye ointments to allow the eye||
3030|047|H|drops to enter the eye.||
3030|048|H|   Wait several minutes for your vision to clear before driving||
3030|049|H|or operating machinery.||
3030|050|H|   Use this medication regularly in order to get the most benefit||
3030|051|H|from it. Remember to use it at the same time each day. Keep using||
3030|052|H|bimatoprost even if you feel well. Most people with glaucoma or||
3030|053|H|high pressure in the eye do not have symptoms.||
3030|054|B|||
3030|055|S|SIDE EFFECTS:  Burning/stinging/irritation/redness of the eye,||
3030|056|S|feeling as if something is in your eye, dry eyes, watering eyes,||
3030|057|S|and increased sensitivity to light may occur. If any of these||
3030|058|S|effects last or get worse, tell your doctor or pharmacist||
3030|059|S|promptly.||
3030|060|S|   This medication may slowly (over months to years) cause brown||
3030|061|S|discoloration of the colored portion of the eye (iris). If you||
3030|062|S|are using bimatoprost in only one eye, only that iris may change||
3030|063|S|color. An increase in eyelash number/length/thickness, darkening||
3030|064|S|of the eyelashes/eyelids, or eyelid changes may also occur in the||
3030|065|S|treated eye. These changes may be permanent, but the long-term||
3030|066|S|effects are uncertain. Notify your doctor if this occurs, and||
3030|067|S|schedule regular eye exams to monitor it.||
3030|068|S|   Remember that this medication has been prescribed because your||
3030|069|S|doctor has judged that the benefit to you is greater than the||
3030|070|S|risk of side effects. Many people using this medication do not||
3030|071|S|have serious side effects.||
3030|072|S|   Tell your doctor right away if you have any serious side||
3030|073|S|effects, including: vision changes, eye pain/swelling,||
3030|074|S|swelling/redness of the eyelids.||
3030|075|S|   A very serious allergic reaction to this drug is rare.||
3030|076|S|However, get medical help right away if you notice any symptoms||
3030|077|S|of a serious allergic reaction, including: rash, itching/swelling||
3030|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3030|079|S|breathing.||
3030|080|S|   This is not a complete list of possible side effects. If you||
3030|081|S|notice other effects not listed above, contact your doctor or||
3030|082|S|pharmacist.||
3030|083|S|   In the US -||
3030|084|S|   Call your doctor for medical advice about side effects. You||
3030|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3030|086|S|www.fda.gov/medwatch.||
3030|087|S|   In Canada - Call your doctor for medical advice about side||
3030|088|S|effects. You may report side effects to Health Canada at||
3030|089|S|1-866-234-2345.||
3030|090|B|||
3030|091|P|PRECAUTIONS:  Before using bimatoprost, tell your doctor or||
3030|092|P|pharmacist if you are allergic to it; or to similar drugs (such||
3030|093|P|as latanoprost, travoprost); or if you have any other allergies.||
3030|094|P|This product may contain inactive ingredients (such as||
3030|095|P|preservatives like benzalkonium chloride or silver), which can||
3030|096|P|cause allergic reactions or other problems. Talk to your||
3030|097|P|pharmacist for more details.||
3030|098|P|   Before using this medication, tell your doctor or pharmacist||
3030|099|P|your medical history, especially of: eye problems (such as||
3030|100|P|macular edema, iritis, uveitis, lens extraction/aphakia).||
3030|101|P|   If you develop an eye infection or injury, or have eye||
3030|102|P|surgery, check with your doctor about the continued use of your||
3030|103|P|current bottle of bimatoprost. You may be advised to start using||
3030|104|P|a new bottle.||
3030|105|P|   After you apply this drug, your vision may become temporarily||
3030|106|P|blurred or unstable. Do not drive, use machinery, or do anything||
3030|107|P|that needs clear vision until you can do it safely.||
3030|108|P|   During pregnancy, this medication should be used only when||
3030|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
3030|110|P|   It is unknown if this drug passes into breast milk. Consult||
3030|111|P|your doctor before breastfeeding.||
3030|112|B|||
3030|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3030|114|I|medications work or increase your risk for serious side effects.||
3030|115|I|This document does not contain all possible drug interactions.||
3030|116|I|Keep a list of all the products you use (including||
3030|117|I|prescription/nonprescription drugs and herbal products) and share||
3030|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
3030|119|I|the dosage of any medicines without your doctor's approval.||
3030|120|I|   Some products that may interact with this drug are: eyelash||
3030|121|I|treatment (such as topically applied bimatoprost).||
3030|122|B|||
3030|123|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3030|124|O|has overdosed and has serious symptoms such as passing out or||
3030|125|O|trouble breathing, call 911. Otherwise, call a poison control||
3030|126|O|center right away. US residents can call 1-800-222-1222. Canada||
3030|127|O|residents can call 1-844-764-7669.||
3030|128|B|||
3030|129|N|NOTES:  Do not share this medication with others.||
3030|130|N|   Lab and/or medical tests (such as eye exams) should be done||
3030|131|N|while you are using this medication. Keep all medical and lab||
3030|132|N|appointments. Consult your doctor for more details.||
3030|133|B|||
3030|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3030|135|D|If it is near the time of the next dose, skip the missed dose.||
3030|136|D|Use your next dose at the regular time. Do not double the dose to||
3030|137|D|catch up.||
3030|138|B|||
3030|139|R|STORAGE:  Different brands of this medication have different||
3030|140|R|storage needs. Check the product package for instructions on how||
3030|141|R|to store your brand, or ask your pharmacist. Keep all medications||
3030|142|R|away from children and pets.||
3030|143|R|   Do not flush medications down the toilet or pour them into a||
3030|144|R|drain unless instructed to do so. Properly discard this product||
3030|145|R|when it is expired or no longer needed. Consult your pharmacist||
3030|146|R|or local waste disposal company.||
3030|147|B|||
3030|148|A|Information last revised May 2024.||
3030|149|A|Copyright(c) 2025 First Databank, Inc.||
3030|150|B|||
3033|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3033|002|Z|does NOT have all possible information about this product. This||
3033|003|Z|information does not assure that this product is safe, effective,||
3033|004|Z|or appropriate for you. This information is not individual||
3033|005|Z|medical advice and does not substitute for the advice of your||
3033|006|Z|health care professional. Always ask your health care||
3033|007|Z|professional for complete information about this product and your||
3033|008|Z|specific health needs.||
3033|009|B|||
3033|010|T|FAMOTIDINE - INJECTION||
3033|011|F|(fam-OH-tih-dine)||
3033|012|B|||
3033|013|C|COMMON BRAND NAME(S): Pepcid||
3033|014|B|||
3033|015|U|USES:  Famotidine is used to treat ulcers of the stomach and||
3033|016|U|intestines and to prevent intestinal ulcers from coming back||
3033|017|U|after they have healed. This medication is also used to treat||
3033|018|U|certain stomach and throat (esophagus) problems (such as erosive||
3033|019|U|esophagitis, gastroesophageal reflux disease-GERD,||
3033|020|U|Zollinger-Ellison syndrome). It works by decreasing the amount of||
3033|021|U|acid your stomach makes. It relieves symptoms such as cough that||
3033|022|U|doesn't go away, stomach pain, heartburn, and difficulty||
3033|023|U|swallowing. Famotidine belongs to a class of drugs known as H2||
3033|024|U|blockers.||
3033|025|U|   This form of famotidine is given by vein and is used to treat||
3033|026|U|these conditions for a short time when you cannot take the||
3033|027|U|medication by mouth. Your doctor should switch you to taking this||
3033|028|U|medication by mouth when possible.||
3033|029|B|||
3033|030|H|HOW TO USE:  This medication is injected into a vein as directed||
3033|031|H|by your doctor. The dosage and length of treatment are based on||
3033|032|H|your medical condition and response to treatment. Children's||
3033|033|H|dosage may also be based on weight.||
3033|034|H|   If you are using this medication at home, learn all||
3033|035|H|preparation and usage instructions from your health care||
3033|036|H|professional. Before injecting each dose, clean the injection||
3033|037|H|site with rubbing alcohol. Before using, check this product for||
3033|038|H|particles or discoloration. If either is present, do not use the||
3033|039|H|liquid. Learn how to store and discard medical supplies safely.||
3033|040|H|   Tell your doctor if your condition lasts or gets worse.||
3033|041|B|||
3033|042|S|SIDE EFFECTS:  Headache, constipation, diarrhea, or pain/redness||
3033|043|S|at the injection site may occur. If any of these effects last or||
3033|044|S|get worse, tell your doctor or pharmacist promptly.||
3033|045|S|   Remember that this medication has been prescribed because your||
3033|046|S|doctor has judged that the benefit to you is greater than the||
3033|047|S|risk of side effects. Many people using this medication do not||
3033|048|S|have serious side effects.||
3033|049|S|   Tell your doctor right away if you have any serious side||
3033|050|S|effects, including: easy bruising/bleeding, signs of infection||
3033|051|S|(such as sore throat that doesn't go away, fever, chills),||
3033|052|S|mental/mood changes (such as restlessness, confusion,||
3033|053|S|depression), hearing/seeing things that are not there||
3033|054|S|(hallucinations).||
3033|055|S|   Get medical help right away if you have any very serious side||
3033|056|S|effects, including: fast/slow/irregular heartbeat, severe||
3033|057|S|dizziness, fainting, seizure.||
3033|058|S|   A very serious allergic reaction to this drug is unlikely, but||
3033|059|S|get medical help right away if it occurs. Symptoms of a serious||
3033|060|S|allergic reaction may include: rash, itching/swelling (especially||
3033|061|S|of the face/tongue/throat), severe dizziness, trouble breathing.||
3033|062|S|   This is not a complete list of possible side effects. If you||
3033|063|S|notice other effects not listed above, contact your doctor or||
3033|064|S|pharmacist.||
3033|065|S|   In the US -||
3033|066|S|   Call your doctor for medical advice about side effects. You||
3033|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3033|068|S|www.fda.gov/medwatch.||
3033|069|S|   In Canada - Call your doctor for medical advice about side||
3033|070|S|effects. You may report side effects to Health Canada at||
3033|071|S|1-866-234-2345.||
3033|072|B|||
3033|073|P|PRECAUTIONS:  Before using famotidine, tell your doctor or||
3033|074|P|pharmacist if you are allergic to it; or to other H2 blockers||
3033|075|P|(such as cimetidine, ranitidine); or if you have any other||
3033|076|P|allergies. This product may contain inactive ingredients, which||
3033|077|P|can cause allergic reactions or other problems. Talk to your||
3033|078|P|pharmacist for more details.||
3033|079|P|   Before using this medication, tell your doctor or pharmacist||
3033|080|P|your medical history, especially of: immune system problems,||
3033|081|P|kidney problems, liver problems, lung problems (such as asthma,||
3033|082|P|chronic obstructive pulmonary disease-COPD), other stomach||
3033|083|P|problems (such as tumors).||
3033|084|P|   Some symptoms may actually be signs of a more serious||
3033|085|P|condition. Get medical help right away if you have: heartburn||
3033|086|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
3033|087|P|pain (especially with shortness of breath, unusual sweating),||
3033|088|P|unexplained weight loss.||
3033|089|P|   Older adults may be more sensitive to the side effects of this||
3033|090|P|drug, especially mental/mood changes (such as confusion),||
3033|091|P|seizure, or unusual tiredness.||
3033|092|P|   During pregnancy, famotidine should be used only when clearly||
3033|093|P|needed. Discuss the risks and benefits with your doctor.||
3033|094|P|   This drug passes into breast milk. Consult your doctor before||
3033|095|P|breastfeeding.||
3033|096|B|||
3033|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3033|098|I|medications work or increase your risk for serious side effects.||
3033|099|I|This document does not contain all possible drug interactions.||
3033|100|I|Keep a list of all the products you use (including||
3033|101|I|prescription/nonprescription drugs and herbal products) and share||
3033|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
3033|103|I|the dosage of any medicines without your doctor's approval.||
3033|104|I|   A product that may interact with this drug is: fezolinetant.||
3033|105|I|   Some products need stomach acid so that the body can absorb||
3033|106|I|them properly. Famotidine decreases stomach acid, so it may||
3033|107|I|change how well these products work. Some affected products||
3033|108|I|include atazanavir, dasatinib, certain azole antifungals (such as||
3033|109|I|itraconazole, ketoconazole), levoketoconazole, pazopanib,||
3033|110|I|sparsentan, among others.||
3033|111|I|   Do not take this medication with other products that contain||
3033|112|I|famotidine or other H2 blockers (cimetidine, nizatidine,||
3033|113|I|ranitidine).||
3033|114|B|||
3033|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3033|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3033|117|O|poison control center right away. US residents can call||
3033|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3033|119|B|||
3033|120|N|NOTES:  Do not share this medication with others.||
3033|121|N|   Lifestyle changes such as stress reduction programs, stopping||
3033|122|N|smoking, limiting alcohol, and diet changes (such as avoiding||
3033|123|N|caffeine and certain spices) may help this medication work||
3033|124|N|better. Talk to your doctor or pharmacist about lifestyle changes||
3033|125|N|that might benefit you.||
3033|126|N|   Lab and/or medical tests (such as endoscopy, kidney function)||
3033|127|N|may be done while you are using this medication. Keep all medical||
3033|128|N|and lab appointments. Consult your doctor for more details.||
3033|129|B|||
3033|130|D|MISSED DOSE:  It is important to get each dose of this medication||
3033|131|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
3033|132|D|right away for a new dosing schedule. Do not double the dose to||
3033|133|D|catch up.||
3033|134|B|||
3033|135|R|STORAGE:  Consult the product instructions and your pharmacist||
3033|136|R|for storage details. Keep all medications away from children and||
3033|137|R|pets.||
3033|138|R|   Do not flush medications down the toilet or pour them into a||
3033|139|R|drain unless instructed to do so. Properly discard this product||
3033|140|R|when it is expired or no longer needed. Consult your pharmacist||
3033|141|R|or local waste disposal company.||
3033|142|B|||
3033|143|A|Information last revised November 2024.||
3033|144|A|Copyright(c) 2025 First Databank, Inc.||
3033|145|B|||
3034|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3034|002|Z|does NOT have all possible information about this product. This||
3034|003|Z|information does not assure that this product is safe, effective,||
3034|004|Z|or appropriate for you. This information is not individual||
3034|005|Z|medical advice and does not substitute for the advice of your||
3034|006|Z|health care professional. Always ask your health care||
3034|007|Z|professional for complete information about this product and your||
3034|008|Z|specific health needs.||
3034|009|B|||
3034|010|T|PIMOZIDE - ORAL||
3034|011|F|(PIM-oh-zide)||
3034|012|B|||
3034|013|C|COMMON BRAND NAME(S): Orap||
3034|014|B|||
3034|015|U|USES:  This medication is used to reduce uncontrolled movements||
3034|016|U|(motor tics) or outbursts of words/sounds (vocal tics) caused by||
3034|017|U|Tourette syndrome. Pimozide is a medication that works by||
3034|018|U|decreasing the activity of a natural substance (dopamine) in the||
3034|019|U|brain.||
3034|020|U|   Pimozide should not be used for mild symptoms. It should only||
3034|021|U|be used if symptoms cause severe problems in everyday life and||
3034|022|U|other medicines or treatments have not been effective.||
3034|023|B|||
3034|024|V|OTHER USES:  This section contains uses of this drug that are not||
3034|025|V|listed in the approved professional labeling for the drug but||
3034|026|V|that may be prescribed by your health care professional. Use this||
3034|027|V|drug for a condition that is listed in this section only if it||
3034|028|V|has been so prescribed by your health care professional.||
3034|029|V|   In Canada, this drug has been used for a certain mental/mood||
3034|030|V|disorder (chronic schizophrenia).||
3034|031|V|   There may be a slightly increased risk of serious, possibly||
3034|032|V|fatal side effects (such as heart failure, fast/irregular||
3034|033|V|heartbeat, pneumonia) when this drug is used by older adults with||
3034|034|V|dementia. This drug is not approved for the treatment of||
3034|035|V|dementia-related behavior problems. Discuss the risks and||
3034|036|V|benefits of this drug, as well as other effective and possibly||
3034|037|V|safer treatments for dementia-related behavior problems, with the||
3034|038|V|doctor.||
3034|039|B|||
3034|040|H|HOW TO USE:  Take this medication by mouth with or without food||
3034|041|H|as directed by your doctor, usually once a day at bedtime.||
3034|042|H|   The dosage is based on your medical condition, lab tests, and||
3034|043|H|response to treatment. Your doctor may direct you to take a low||
3034|044|H|dose at first, gradually increasing the dose to lower the chance||
3034|045|H|of side effects such as shaking (tremors).||
3034|046|H|   Do not take this drug more often or increase the dose. Your||
3034|047|H|symptoms will not improve any faster, and the risk for heart||
3034|048|H|rhythm problems will be increased. Follow your doctor's||
3034|049|H|directions carefully.||
3034|050|H|   Your doctor may order an electrocardiogram (EKG) and lab tests||
3034|051|H|before you start this medication. These tests are to find out||
3034|052|H|whether you are at risk for heart rhythm problems from pimozide.||
3034|053|H|Keep all medical/lab appointments.||
3034|054|H|   Other drugs, such as stimulant medications (such as||
3034|055|H|methylphenidate, dextroamphetamine), may occasionally worsen||
3034|056|H|tics. Before deciding to start pimozide, your doctor may try to||
3034|057|H|reduce your tics by lowering the stimulant dose. Consult your||
3034|058|H|doctor for more details.||
3034|059|H|   Avoid eating grapefruit or drinking grapefruit juice while||
3034|060|H|using this medication unless your doctor or pharmacist says you||
3034|061|H|may do so safely. Grapefruit can increase the chance of side||
3034|062|H|effects with this medicine. Ask your doctor or pharmacist for||
3034|063|H|more details.||
3034|064|H|   Use this medication regularly to get the most benefit from it.||
3034|065|H|To help you remember, take it at the same time each day.||
3034|066|H|   Do not stop taking this medication without consulting your||
3034|067|H|doctor. Your condition may become worse when the drug is suddenly||
3034|068|H|stopped. Your dose may need to be gradually decreased.||
3034|069|H|   Tell your doctor if your condition lasts or gets worse.||
3034|070|B|||
3034|071|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, dry mouth,||
3034|072|S|blurred vision, tiredness, or weakness may occur. If any of these||
3034|073|S|effects last or get worse, tell your doctor or pharmacist||
3034|074|S|promptly.||
3034|075|S|   Dizziness and lightheadedness can increase the risk of||
3034|076|S|falling. Get up slowly when rising from a sitting or lying||
3034|077|S|position.||
3034|078|S|   Tell your doctor right away if any of these side effects||
3034|079|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
3034|080|S|mask-like expression of the face, drooling/trouble swallowing, or||
3034|081|S|shuffling walk. Your doctor may prescribe another medication to||
3034|082|S|decrease these side effects.||
3034|083|S|   Remember that this medication has been prescribed because your||
3034|084|S|doctor has judged that the benefit to you is greater than the||
3034|085|S|risk of side effects. Many people using this medication do not||
3034|086|S|have serious side effects.||
3034|087|S|   This medication may cause a condition known as tardive||
3034|088|S|dyskinesia. In some cases, this condition may be permanent. Tell||
3034|089|S|your doctor right away if you develop any involuntary/repetitive||
3034|090|S|muscle movements such as lip smacking/puckering, tongue||
3034|091|S|thrusting, chewing, or finger/toe movements.||
3034|092|S|   In rare cases, pimozide may increase your level of a certain||
3034|093|S|chemical made by the body (prolactin). For females, this increase||
3034|094|S|in prolactin may result in unwanted breast milk, missed/stopped||
3034|095|S|periods, or difficulty becoming pregnant. For males, it may||
3034|096|S|result in decreased sexual ability, inability to produce sperm,||
3034|097|S|or enlarged breasts. If you develop any of these symptoms, tell||
3034|098|S|your doctor right away.||
3034|099|S|   Tell your doctor right away if you have any serious side||
3034|100|S|effects, including: signs of infection (such as sore throat that||
3034|101|S|doesn't go away, fever, chills).||
3034|102|S|   Get medical help right away if you have any very serious side||
3034|103|S|effects, including: severe dizziness, fainting, slow heartbeat,||
3034|104|S|seizures.||
3034|105|S|   This medication may rarely cause a very serious condition||
3034|106|S|called neuroleptic malignant syndrome (NMS). Get medical help||
3034|107|S|right away if you have any of the following symptoms: fever,||
3034|108|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
3034|109|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
3034|110|S|signs of kidney problems (such as change in the amount of urine).||
3034|111|S|   A very serious allergic reaction to this drug is rare.||
3034|112|S|However, get medical help right away if you notice any symptoms||
3034|113|S|of a serious allergic reaction, including: rash, itching/swelling||
3034|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3034|115|S|breathing.||
3034|116|S|   This is not a complete list of possible side effects. If you||
3034|117|S|notice other effects not listed above, contact your doctor or||
3034|118|S|pharmacist.||
3034|119|S|   In the US -||
3034|120|S|   Call your doctor for medical advice about side effects. You||
3034|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3034|122|S|www.fda.gov/medwatch.||
3034|123|S|   In Canada - Call your doctor for medical advice about side||
3034|124|S|effects. You may report side effects to Health Canada at||
3034|125|S|1-866-234-2345.||
3034|126|B|||
3034|127|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
3034|128|P|pharmacist if you are allergic to it; or if you have any other||
3034|129|P|allergies. This product may contain inactive ingredients, which||
3034|130|P|can cause allergic reactions or other problems. Talk to your||
3034|131|P|pharmacist for more details.||
3034|132|P|   Before using this medication, tell your doctor or pharmacist||
3034|133|P|your medical history, especially of: blood problems (such as a||
3034|134|P|low white blood cell count), a certain eye condition (glaucoma),||
3034|135|P|dementia, depression, heart problems (such as slow/fast/irregular||
3034|136|P|heartbeat, low blood pressure), slow movement of the||
3034|137|P|gut/intestines (such as chronic constipation, blockage), kidney||
3034|138|P|disease, liver disease, brain disorder/tumor/injury,||
3034|139|P|drug/alcohol/substance abuse, breast cancer, Parkinson's disease,||
3034|140|P|seizure disorder, a certain severe reaction to other||
3034|141|P|antipsychotic-type medications (neuroleptic malignant||
3034|142|P|syndrome-NMS), difficulty urinating (such as due to prostate||
3034|143|P|problems).||
3034|144|P|   This drug may make you dizzy or drowsy or cause vision||
3034|145|P|changes. Alcohol or marijuana (cannabis) can make you more dizzy||
3034|146|P|or drowsy. Do not drive, use machinery, or do anything that needs||
3034|147|P|alertness or clear vision until you can do it safely. Avoid||
3034|148|P|alcoholic beverages. Talk to your doctor if you are using||
3034|149|P|marijuana (cannabis).||
3034|150|P|   Pimozide may cause a condition that affects the heart rhythm||
3034|151|P|(QT prolongation). QT prolongation can rarely cause serious||
3034|152|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
3034|153|P|as severe dizziness, fainting) that need medical attention right||
3034|154|P|away.||
3034|155|P|   The risk of QT prolongation may be increased if you have||
3034|156|P|certain medical conditions or are taking other drugs that may||
3034|157|P|cause QT prolongation. Before using pimozide, tell your doctor or||
3034|158|P|pharmacist of all the drugs you take and if you have any of the||
3034|159|P|following conditions: certain heart problems (heart failure, slow||
3034|160|P|heartbeat, QT prolongation in the EKG), family history of certain||
3034|161|P|heart problems (QT prolongation in the EKG, sudden cardiac||
3034|162|P|death).||
3034|163|P|   Low levels of potassium or magnesium in the blood may also||
3034|164|P|increase your risk of QT prolongation. This risk may increase if||
3034|165|P|you use certain drugs (such as diuretics/"water pills") or if you||
3034|166|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3034|167|P|Talk to your doctor about using pimozide safely.||
3034|168|P|   Before having surgery or imaging procedures (such as certain||
3034|169|P|X-rays, CT scans) requiring the use of contrast dye (such as||
3034|170|P|metrizamide), tell your doctor or dentist that you are using this||
3034|171|P|medication and about all the products you use (including||
3034|172|P|prescription drugs, nonprescription drugs, and herbal products).||
3034|173|P|   Children may be more sensitive to the side effects of this||
3034|174|P|drug, especially uncontrolled movements.||
3034|175|P|   Older adults may be more sensitive to the side effects of this||
3034|176|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
3034|177|P|prolongation (see above). Drowsiness, dizziness, and||
3034|178|P|lightheadedness can increase the risk of falling.||
3034|179|P|   During pregnancy, this medication should be used only when||
3034|180|P|clearly needed. Babies born to mothers who have used this drug||
3034|181|P|during the last 3 months of pregnancy may rarely develop symptoms||
3034|182|P|including muscle stiffness or shakiness, drowsiness,||
3034|183|P|feeding/breathing difficulties, or constant crying. If you notice||
3034|184|P|any of these symptoms in your newborn especially during their||
3034|185|P|first month, tell the doctor right away.||
3034|186|P|   Since untreated mental/mood problems (such as schizophrenia)||
3034|187|P|can be a serious condition, do not stop taking this medication||
3034|188|P|unless directed by your doctor. If you are planning pregnancy,||
3034|189|P|become pregnant, or think you may be pregnant, immediately||
3034|190|P|discuss with your doctor the benefits and risks of using this||
3034|191|P|medication during pregnancy.||
3034|192|P|   It is unknown if this drug passes into breast milk. Consult||
3034|193|P|your doctor before breastfeeding.||
3034|194|B|||
3034|195|I|DRUG INTERACTIONS:  See also How to Use section.||
3034|196|I|   Drug interactions may change how your medications work or||
3034|197|I|increase your risk for serious side effects. This document does||
3034|198|I|not contain all possible drug interactions. Keep a list of all||
3034|199|I|the products you use (including prescription/nonprescription||
3034|200|I|drugs and herbal products) and share it with your doctor and||
3034|201|I|pharmacist. Do not start, stop, or change the dosage of any||
3034|202|I|medicines without your doctor's approval.||
3034|203|I|   Other medications can affect the removal of pimozide from your||
3034|204|I|body, which may affect how pimozide works. Examples include||
3034|205|I|aprepitant, azole antifungals (such as ketoconazole,||
3034|206|I|itraconazole), HIV protease inhibitors (such as nelfinavir),||
3034|207|I|letermovir, nefazodone, SSRI antidepressants (such as||
3034|208|I|fluvoxamine, paroxetine, sertraline), ritonavir, tucatinib,||
3034|209|I|zileuton, among others.||
3034|210|I|   Tell your doctor or pharmacist if you are taking other||
3034|211|I|products that cause drowsiness including alcohol, marijuana||
3034|212|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
3034|213|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
3034|214|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
3034|215|I|codeine).||
3034|216|I|   Check the labels on all your medicines (such as allergy or||
3034|217|I|cough-and-cold products) because they may contain ingredients||
3034|218|I|that cause drowsiness. Ask your pharmacist about using those||
3034|219|I|products safely.||
3034|220|I|   Many drugs besides pimozide may affect the heart rhythm (QT||
3034|221|I|prolongation). Examples include amiodarone,||
3034|222|I|citalopram/escitalopram, chlorpromazine, dofetilide,||
3034|223|I|procainamide, quinidine, ranolazine, sotalol, macrolide||
3034|224|I|antibiotics (such as clarithromycin, erythromycin), among others.||
3034|225|B|||
3034|226|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3034|227|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3034|228|O|poison control center right away. US residents can call||
3034|229|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3034|230|O|Symptoms of overdose may include: slow/shallow breathing,||
3034|231|O|inability to wake up (coma).||
3034|232|B|||
3034|233|N|NOTES:  Do not share this medication with others.||
3034|234|N|   Lab and/or medical tests (such as electrocardiogram-EKG,||
3034|235|N|complete blood count) should be done while you are taking this||
3034|236|N|medication. Keep all medical and lab appointments. Consult your||
3034|237|N|doctor for more details.||
3034|238|B|||
3034|239|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3034|240|D|remember. If it is near the time of the next dose, skip the||
3034|241|D|missed dose. Take your next dose at the regular time. Do not||
3034|242|D|double the dose to catch up.||
3034|243|B|||
3034|244|R|STORAGE:  Store at room temperature away from light and moisture.||
3034|245|R|Do not store in the bathroom. Keep all medications away from||
3034|246|R|children and pets.||
3034|247|R|   Do not flush medications down the toilet or pour them into a||
3034|248|R|drain unless instructed to do so. Properly discard this product||
3034|249|R|when it is expired or no longer needed. Consult your pharmacist||
3034|250|R|or local waste disposal company.||
3034|251|B|||
3034|252|A|Information last revised May 2025.||
3034|253|A|Copyright(c) 2025 First Databank, Inc.||
3034|254|B|||
3039|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3039|002|Z|does NOT have all possible information about this product. This||
3039|003|Z|information does not assure that this product is safe, effective,||
3039|004|Z|or appropriate for you. This information is not individual||
3039|005|Z|medical advice and does not substitute for the advice of your||
3039|006|Z|health care professional. Always ask your health care||
3039|007|Z|professional for complete information about this product and your||
3039|008|Z|specific health needs.||
3039|009|B|||
3039|010|T|ALITRETINOIN GEL - TOPICAL||
3039|011|F|(AL-i-TRET-i-noyn)||
3039|012|B|||
3039|013|C|COMMON BRAND NAME(S): Panretin||
3039|014|B|||
3039|015|U|USES:  This medication is used to treat skin sores in patients||
3039|016|U|with a certain type of AIDS-related cancer (Kaposi's sarcoma).||
3039|017|U|Alitretinoin belongs to a class of medications called retinoids.||
3039|018|U|It works by affecting the growth of skin cells.||
3039|019|U|   This medication should not be used when medications taken by||
3039|020|U|mouth are needed to treat the Kaposi's sarcoma (for example, if||
3039|021|U|you have had more than 10 new skin sores in the previous month,||
3039|022|U|or if the disease affects the lungs or other organs).||
3039|023|B|||
3039|024|H|HOW TO USE:  Use this medication on the skin only. Wait at least||
3039|025|H|20 minutes after bathing or showering before applying the||
3039|026|H|medication. Apply enough medication to cover the skin sore(s)||
3039|027|H|well as directed by your doctor, usually 2 to 4 times daily. It||
3039|028|H|is not necessary to rub the medication into the sore. Allow 3 to||
3039|029|H|5 minutes for the medication to dry before covering the affected||
3039|030|H|area with clothing.||
3039|031|H|   Do not apply the medication on unaffected skin because doing||
3039|032|H|so may cause increased irritation. Do not apply the medication in||
3039|033|H|or around the eyes, nose, mouth, anus, vagina, or tip of the||
3039|034|H|penis. If you do get the medication in those areas, flush with||
3039|035|H|plenty of water.||
3039|036|H|   Wash your hands after using, unless you are using this||
3039|037|H|medication to treat the hands. Do not bathe, shower, or swim for||
3039|038|H|at least 3 hours after using the medication.||
3039|039|H|   Do not wrap, cover, or bandage the affected area unless||
3039|040|H|directed to do so by your doctor.||
3039|041|H|   Use this medication regularly in order to get the most benefit||
3039|042|H|from it. To help you remember, use it at the same times each day.||
3039|043|H|   Do not apply other skin products, except mineral oil, on the||
3039|044|H|treated sores. You may apply mineral oil at least 2 hours before||
3039|045|H|or after applying this medication to help prevent skin||
3039|046|H|dryness/itching.||
3039|047|H|   Since this drug is absorbed through the skin and may harm an||
3039|048|H|unborn baby, women who are pregnant or who may become pregnant||
3039|049|H|should not handle this medication.||
3039|050|H|   Tell your doctor if your condition does not get better or if||
3039|051|H|it gets worse. You should start to see an improvement in your||
3039|052|H|skin condition in as little as 2 weeks of treatment, but it may||
3039|053|H|take up to 14 weeks of treatment to see the benefit.||
3039|054|B|||
3039|055|S|SIDE EFFECTS:  Redness, rash, pain, burning, itching, stinging,||
3039|056|S|or tingling at the application site may occur. If any of these||
3039|057|S|effects last or get worse, tell your doctor or pharmacist||
3039|058|S|promptly.||
3039|059|S|   Remember that this medication has been prescribed because your||
3039|060|S|doctor has judged that the benefit to you is greater than the||
3039|061|S|risk of side effects. Many people using this medication do not||
3039|062|S|have serious side effects.||
3039|063|S|   Tell your doctor right away if you have any serious side||
3039|064|S|effects, including: blistering/crusting/oozing/peeling of the||
3039|065|S|skin, severe burning/stinging of the skin, swelling of the skin.||
3039|066|S|   A very serious allergic reaction to this drug is rare.||
3039|067|S|However, get medical help right away if you notice any symptoms||
3039|068|S|of a serious allergic reaction, including: rash, itching/swelling||
3039|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3039|070|S|breathing.||
3039|071|S|   This is not a complete list of possible side effects. If you||
3039|072|S|notice other effects not listed above, contact your doctor or||
3039|073|S|pharmacist.||
3039|074|S|   In the US -||
3039|075|S|   Call your doctor for medical advice about side effects. You||
3039|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3039|077|S|www.fda.gov/medwatch.||
3039|078|S|   In Canada - Call your doctor for medical advice about side||
3039|079|S|effects. You may report side effects to Health Canada at||
3039|080|S|1-866-234-2345.||
3039|081|B|||
3039|082|P|PRECAUTIONS:  Before using alitretinoin, tell your doctor or||
3039|083|P|pharmacist if you are allergic to it; or to vitamin A-related||
3039|084|P|drugs (other retinoids such as isotretinoin); or if you have any||
3039|085|P|other allergies. This product may contain inactive ingredients,||
3039|086|P|which can cause allergic reactions or other problems. Talk to||
3039|087|P|your pharmacist for more details.||
3039|088|P|   Before using this medication, tell your doctor or pharmacist||
3039|089|P|your medical history, especially of: a certain type of cancer||
3039|090|P|(skin T-cell lymphoma).||
3039|091|P|   This medication may make you more sensitive to the sun. Limit||
3039|092|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
3039|093|P|sunscreen and wear protective clothing when outdoors. Tell your||
3039|094|P|doctor right away if you get sunburned or have skin||
3039|095|P|blisters/redness.||
3039|096|P|   Tell your doctor if you are pregnant or plan to become||
3039|097|P|pregnant. You should not become pregnant while using||
3039|098|P|alitretinoin. Alitretinoin may harm an unborn baby. If you become||
3039|099|P|pregnant, talk to your doctor right away about the risks and||
3039|100|P|benefits of this medication.||
3039|101|P|   Since this drug is absorbed through the skin and may harm an||
3039|102|P|unborn baby, women who are pregnant or who may become pregnant||
3039|103|P|should not handle this medication.||
3039|104|P|   It is unknown if this drug passes into breast milk. Because of||
3039|105|P|the possible risk to the infant, breastfeeding is not recommended||
3039|106|P|while using this drug. Consult your doctor before breastfeeding.||
3039|107|B|||
3039|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3039|109|I|medications work or increase your risk for serious side effects.||
3039|110|I|This document does not contain all possible drug interactions.||
3039|111|I|Keep a list of all the products you use (including||
3039|112|I|prescription/nonprescription drugs and herbal products) and share||
3039|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
3039|114|I|the dosage of any medicines without your doctor's approval.||
3039|115|I|   Some products that may interact with this drug are: products||
3039|116|I|containing DEET (such as some insect repellents).||
3039|117|B|||
3039|118|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3039|119|O|has overdosed and has serious symptoms such as passing out or||
3039|120|O|trouble breathing, call 911. Otherwise, call a poison control||
3039|121|O|center right away. US residents can call 1-800-222-1222. Canada||
3039|122|O|residents can call 1-844-764-7669.||
3039|123|B|||
3039|124|N|NOTES:  Do not share this medication with others.||
3039|125|B|||
3039|126|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3039|127|D|If it is near the time of the next dose, skip the missed dose.||
3039|128|D|Use your next dose at the regular time. Do not double the dose to||
3039|129|D|catch up.||
3039|130|B|||
3039|131|R|STORAGE:  Store at room temperature. This product is flammable.||
3039|132|R|Keep it away from heat and open flame. Keep all medications away||
3039|133|R|from children and pets.||
3039|134|R|   Do not flush medications down the toilet or pour them into a||
3039|135|R|drain unless instructed to do so. Properly discard this product||
3039|136|R|when it is expired or no longer needed. Consult your pharmacist||
3039|137|R|or local waste disposal company.||
3039|138|B|||
3039|139|A|Information last revised July 2025.||
3039|140|A|Copyright(c) 2025 First Databank, Inc.||
3039|141|B|||
3041|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3041|002|Z|does NOT have all possible information about this product. This||
3041|003|Z|information does not assure that this product is safe, effective,||
3041|004|Z|or appropriate for you. This information is not individual||
3041|005|Z|medical advice and does not substitute for the advice of your||
3041|006|Z|health care professional. Always ask your health care||
3041|007|Z|professional for complete information about this product and your||
3041|008|Z|specific health needs.||
3041|009|B|||
3041|010|T|TOLCAPONE - ORAL||
3041|011|F|(TOLL-cup-own)||
3041|012|B|||
3041|013|C|COMMON BRAND NAME(S): Tasmar||
3041|014|B|||
3041|015|W|WARNING:  Rarely, tolcapone has caused a severe (sometimes fatal)||
3041|016|W|liver problem (liver failure). Tolcapone should not be used if||
3041|017|W|you have even mild liver disease. You should only use tolcapone||
3041|018|W|if you are experiencing problems with your levodopa wearing off||
3041|019|W|between doses. If you show no benefit from tolcapone after 3||
3041|020|W|weeks of using it, your doctor may choose to stop it.||
3041|021|W|   Before and during treatment with tolcapone, you will have||
3041|022|W|certain blood tests (liver function tests) every few weeks to||
3041|023|W|monitor for liver problems. Keep all medical and lab test||
3041|024|W|appointments. Tell your doctor right away if you experience||
3041|025|W|symptoms of liver problems (such as nausea/vomiting that doesn't||
3041|026|W|stop, abdominal pain, dark urine, severe tiredness, loss of||
3041|027|W|appetite, itchiness). If you experience liver problems from||
3041|028|W|taking tolcapone, you should not take it again.||
3041|029|W|   Your doctor may ask you to sign a consent form after telling||
3041|030|W|you about the possible side effects of this medication.||
3041|031|B|||
3041|032|U|USES:  This medication is used with other medications||
3041|033|U|(levodopa/carbidopa) to treat Parkinson's disease. Tolcapone||
3041|034|U|belongs to a class of drugs known as COMT inhibitors. Many people||
3041|035|U|taking levodopa for Parkinson's have problems with the effects of||
3041|036|U|the levodopa wearing off between scheduled doses, causing||
3041|037|U|symptoms to return or worsen. Tolcapone blocks a certain natural||
3041|038|U|substance (COMT enzyme) that breaks down levodopa in the body.||
3041|039|U|This effect allows the levodopa to last longer in the system so||
3041|040|U|that it doesn't wear off before the next dose.||
3041|041|B|||
3041|042|H|HOW TO USE:  Take this medication by mouth with or without food||
3041|043|H|as directed by your doctor, usually 3 times daily. You will start||
3041|044|H|on a low dose. Your doctor may increase your dosage after 3 weeks||
3041|045|H|if your doctor thinks that you will benefit from a higher dose.||
3041|046|H|   The dosage is based on your medical condition and response to||
3041|047|H|treatment.||
3041|048|H|   Use this medication regularly to get the most benefit from it.||
3041|049|H|To help you remember, take it at the same times each day. Do not||
3041|050|H|suddenly stop taking this medication unless instructed to do so||
3041|051|H|by your doctor. Doing so may cause your Parkinson's symptoms to||
3041|052|H|become much worse.||
3041|053|H|   Tell your doctor if your condition lasts or gets worse (such||
3041|054|H|as your Parkinson's symptoms are not controlled).||
3041|055|B|||
3041|056|S|SIDE EFFECTS:  See also Warning section.||
3041|057|S|   Nausea/vomiting, unwanted/uncontrolled movements, diarrhea,||
3041|058|S|headache, drowsiness, dizziness, lightheadedness, trouble||
3041|059|S|sleeping, increased number of dreams, increased sweating, dry||
3041|060|S|mouth, gas, and abdominal pain may occur. If any of these effects||
3041|061|S|last or get worse, tell your doctor or pharmacist promptly.||
3041|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
3041|063|S|slowly when rising from a sitting or lying position.||
3041|064|S|   Remember that this medication has been prescribed because your||
3041|065|S|doctor has judged that the benefit to you is greater than the||
3041|066|S|risk of side effects. Many people using this medication do not||
3041|067|S|have serious side effects.||
3041|068|S|   Tell your doctor right away if you have any serious side||
3041|069|S|effects, including: easy bleeding/bruising, chest pain,||
3041|070|S|fast/irregular heartbeat, fever, mental/mood changes (such as||
3041|071|S|agitation, confusion, hallucinations), unusual strong urges (such||
3041|072|S|as increased gambling, increased sexual urges), muscle||
3041|073|S|pain/soreness/stiffness/weakness, pain/trouble with breathing.||
3041|074|S|   Some people taking tolcapone have fallen asleep suddenly||
3041|075|S|during their usual daily activities (such as talking on the||
3041|076|S|phone, driving). In some cases, sleep occurred without any||
3041|077|S|feelings of drowsiness beforehand. This sleep effect may occur||
3041|078|S|anytime during treatment with tolcapone even if you have used||
3041|079|S|this medication for a long time. If you experience increased||
3041|080|S|sleepiness or fall asleep during the day, do not drive or take||
3041|081|S|part in other possibly dangerous activities until you have||
3041|082|S|discussed this effect with your doctor. Your risk of this sleep||
3041|083|S|effect is increased by using alcohol or other medications that||
3041|084|S|can make you drowsy. See also Precautions section.||
3041|085|S|   A very serious allergic reaction to this drug is rare.||
3041|086|S|However, get medical help right away if you notice any symptoms||
3041|087|S|of a serious allergic reaction, including: rash, itching/swelling||
3041|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3041|089|S|breathing.||
3041|090|S|   This is not a complete list of possible side effects. If you||
3041|091|S|notice other effects not listed above, contact your doctor or||
3041|092|S|pharmacist.||
3041|093|S|   In the US -||
3041|094|S|   Call your doctor for medical advice about side effects. You||
3041|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3041|096|S|www.fda.gov/medwatch.||
3041|097|S|   In Canada - Call your doctor for medical advice about side||
3041|098|S|effects. You may report side effects to Health Canada at||
3041|099|S|1-866-234-2345.||
3041|100|B|||
3041|101|P|PRECAUTIONS:  See also Warning section.||
3041|102|P|   Before taking tolcapone, tell your doctor or pharmacist if you||
3041|103|P|are allergic to it; or if you have any other allergies. This||
3041|104|P|product may contain inactive ingredients, which can cause||
3041|105|P|allergic reactions or other problems. Talk to your pharmacist for||
3041|106|P|more details.||
3041|107|P|   Before using this medication, tell your doctor or pharmacist||
3041|108|P|your medical history, especially of: alcoholism, low blood||
3041|109|P|pressure, Parkinson's with severe movement problems, liver||
3041|110|P|problems, mental/mood disorders (such as psychosis,||
3041|111|P|schizophrenia), history of a certain muscle problem||
3041|112|P|(rhabdomyolysis), fever and confusion caused by any drug.||
3041|113|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3041|114|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3041|115|P|machinery, or do anything that needs alertness until you can do||
3041|116|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
3041|117|P|are using marijuana (cannabis). See also Side Effects section.||
3041|118|P|   Before having surgery, tell your doctor or dentist about all||
3041|119|P|the products you use (including prescription drugs,||
3041|120|P|nonprescription drugs, and herbal products).||
3041|121|P|   Older adults may be more sensitive to the side effects of this||
3041|122|P|drug, especially drowsiness, confusion, and hallucinations.||
3041|123|P|   During pregnancy, this medication should be used only when||
3041|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
3041|125|P|   It is unknown if this medication passes into breast milk.||
3041|126|P|Consult your doctor before breastfeeding.||
3041|127|B|||
3041|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3041|129|I|medications work or increase your risk for serious side effects.||
3041|130|I|This document does not contain all possible drug interactions.||
3041|131|I|Keep a list of all the products you use (including||
3041|132|I|prescription/nonprescription drugs and herbal products) and share||
3041|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
3041|134|I|the dosage of any medicines without your doctor's approval.||
3041|135|I|   Some of the products that may interact with this drug include:||
3041|136|I|certain MAO inhibitors (isocarboxazid, linezolid, metaxalone,||
3041|137|I|methylene blue, moclobemide, phenelzine, procarbazine,||
3041|138|I|tranylcypromine).||
3041|139|I|   Other MAO inhibitors (safinamide, selegiline, rasagiline) may||
3041|140|I|be used cautiously with close monitoring by your doctor. If you||
3041|141|I|are taking rasagiline or selegiline for Parkinson's disease, ask||
3041|142|I|your doctor if you should keep taking it.||
3041|143|I|   Tolcapone can slow down the removal of other drugs from your||
3041|144|I|body, thereby affecting how they work. These affected drugs||
3041|145|I|include apomorphine, dobutamine, and methyldopa. This is not a||
3041|146|I|complete list.||
3041|147|I|   Tell your doctor or pharmacist if you are taking other||
3041|148|I|products that cause drowsiness including alcohol, marijuana||
3041|149|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
3041|150|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
3041|151|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
3041|152|I|codeine).||
3041|153|I|   Check the labels on all your medicines (such as allergy or||
3041|154|I|cough-and-cold products) because they may contain ingredients||
3041|155|I|that cause drowsiness. Ask your pharmacist about using those||
3041|156|I|products safely.||
3041|157|B|||
3041|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3041|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3041|160|O|poison control center right away. US residents can call||
3041|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3041|162|B|||
3041|163|N|NOTES:  Do not share this medication with others.||
3041|164|N|   Lab and/or medical tests (such as liver function) should be||
3041|165|N|done before you start taking this medication and while you are||
3041|166|N|taking it. Keep all medical and lab appointments. Consult your||
3041|167|N|doctor for more details.||
3041|168|B|||
3041|169|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3041|170|D|remember. If it is near the time of the next dose, skip the||
3041|171|D|missed dose. Take your next dose at the regular time. Do not||
3041|172|D|double the dose to catch up.||
3041|173|B|||
3041|174|R|STORAGE:  Store at room temperature away from light and moisture.||
3041|175|R|Do not store in the bathroom. Keep all medications away from||
3041|176|R|children and pets.||
3041|177|R|   Do not flush medications down the toilet or pour them into a||
3041|178|R|drain unless instructed to do so. Properly discard this product||
3041|179|R|when it is expired or no longer needed. Consult your pharmacist||
3041|180|R|or local waste disposal company.||
3041|181|B|||
3041|182|A|Information last revised June 2024.||
3041|183|A|Copyright(c) 2025 First Databank, Inc.||
3041|184|B|||
3043|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3043|002|Z|does NOT have all possible information about this product. This||
3043|003|Z|information does not assure that this product is safe, effective,||
3043|004|Z|or appropriate for you. This information is not individual||
3043|005|Z|medical advice and does not substitute for the advice of your||
3043|006|Z|health care professional. Always ask your health care||
3043|007|Z|professional for complete information about this product and your||
3043|008|Z|specific health needs.||
3043|009|B|||
3043|010|T|ETHACRYNATE SODIUM - INJECTION||
3043|011|F|(ETH-a-KRIN-ate SOE-dee-um)||
3043|012|B|||
3043|013|C|COMMON BRAND NAME(S): Edecrin||
3043|014|B|||
3043|015|U|USES:  Ethacrynate sodium is used to decrease swelling (edema)||
3043|016|U|caused by conditions such as cancer, heart failure, liver||
3043|017|U|disease, and kidney disease. This medication works in your||
3043|018|U|kidneys like a "water pill"/diuretic to increase the amount of||
3043|019|U|urine you make. This effect can help your kidneys work better and||
3043|020|U|lessen symptoms such as trouble breathing and swelling in your||
3043|021|U|ankles, feet, hands, or belly.||
3043|022|U|   This medication should not be used for infants.||
3043|023|B|||
3043|024|V|OTHER USES:  This section contains uses of this drug that are not||
3043|025|V|listed in the approved professional labeling for the drug but||
3043|026|V|that may be prescribed by your health care professional. Use this||
3043|027|V|drug for a condition that is listed in this section only if it||
3043|028|V|has been so prescribed by your health care professional.||
3043|029|V|   This drug may also be used for high blood pressure.||
3043|030|B|||
3043|031|H|HOW TO USE:  This medication is given by injection into a vein as||
3043|032|H|directed by your doctor. It is usually given by a health care||
3043|033|H|professional.||
3043|034|H|   The dosage is based on your medical condition, lab tests, and||
3043|035|H|response to treatment.||
3043|036|H|   If you use this drug too close to bedtime, you may need to||
3043|037|H|wake up to urinate. It is best to use this medication at least 4||
3043|038|H|hours before your bedtime. Consult your doctor or pharmacist if||
3043|039|H|you have questions about your dosing schedule.||
3043|040|H|   Tell your doctor if you do not get better or if you get worse.||
3043|041|B|||
3043|042|S|SIDE EFFECTS:  Pain at the injection site, dizziness,||
3043|043|S|lightheadedness, weakness, muscle cramps, upset stomach, or||
3043|044|S|diarrhea may occur. If any of these effects last or get worse,||
3043|045|S|tell your doctor or pharmacist promptly.||
3043|046|S|   To reduce the risk of dizziness and lightheadedness, get up||
3043|047|S|slowly when rising from a sitting or lying position.||
3043|048|S|   Remember that this medication has been prescribed because your||
3043|049|S|doctor has judged that the benefit to you is greater than the||
3043|050|S|risk of side effects. Many people using this medication do not||
3043|051|S|have serious side effects.||
3043|052|S|   This medication may cause dehydration and electrolyte||
3043|053|S|imbalance. Tell your doctor right away if you have any symptoms||
3043|054|S|of dehydration or electrolyte imbalance, including unusual dry||
3043|055|S|mouth/thirst, unusual decreased urination, muscle||
3043|056|S|cramps/weakness, slow/fast/irregular heartbeat, or confusion.||
3043|057|S|   Tell your doctor right away if you have any serious side||
3043|058|S|effects, including: easy bleeding/bruising, fainting, feeling of||
3043|059|S|spinning (vertigo), hearing changes (such as ringing or fullness||
3043|060|S|in the ears, decreased hearing/deafness), black/bloody stools,||
3043|061|S|stomach/abdominal pain, vomit that looks like coffee grounds,||
3043|062|S|signs of liver problems (such as nausea/vomiting that doesn't||
3043|063|S|stop, loss of appetite, yellowing eyes/skin, dark urine).||
3043|064|S|   A very serious allergic reaction to this drug is rare.||
3043|065|S|However, get medical help right away if you notice any symptoms||
3043|066|S|of a serious allergic reaction, including: rash, itching/swelling||
3043|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3043|068|S|breathing.||
3043|069|S|   This is not a complete list of possible side effects. If you||
3043|070|S|notice other effects not listed above, contact your doctor or||
3043|071|S|pharmacist.||
3043|072|S|   In the US -||
3043|073|S|   Call your doctor for medical advice about side effects. You||
3043|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3043|075|S|www.fda.gov/medwatch.||
3043|076|S|   In Canada - Call your doctor for medical advice about side||
3043|077|S|effects. You may report side effects to Health Canada at||
3043|078|S|1-866-234-2345.||
3043|079|B|||
3043|080|P|PRECAUTIONS:  Before using ethacrynate sodium, tell your doctor||
3043|081|P|or pharmacist if you are allergic to it; or if you have any other||
3043|082|P|allergies. This product may contain inactive ingredients, which||
3043|083|P|can cause allergic reactions or other problems. Talk to your||
3043|084|P|pharmacist for more details.||
3043|085|P|   Before using this medication, tell your doctor or pharmacist||
3043|086|P|your medical history, especially of: gout, kidney disease, liver||
3043|087|P|disease.||
3043|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3043|089|P|can make you more dizzy. Do not drive, use machinery, or do||
3043|090|P|anything that needs alertness until you can do it safely. Avoid||
3043|091|P|alcoholic beverages. Talk to your doctor if you are using||
3043|092|P|marijuana (cannabis).||
3043|093|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
3043|094|P|and cause you to feel lightheaded. Tell your doctor if you have||
3043|095|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
3043|096|P|of fluids unless your doctor tells you not to.||
3043|097|P|   This drug can lower certain salt/mineral levels (such as||
3043|098|P|sodium, potassium) in your blood. Your doctor may tell you to use||
3043|099|P|more salt, eat potassium-rich foods (such as bananas, orange||
3043|100|P|juice), or take a potassium supplement. Ask your doctor for more||
3043|101|P|details.||
3043|102|P|   This medication may affect your blood sugar. If you have||
3043|103|P|diabetes, check your blood sugar regularly as directed and share||
3043|104|P|the results with your doctor. Your doctor may need to adjust your||
3043|105|P|diabetes medication, exercise program, or diet.||
3043|106|P|   Before having surgery, tell your doctor or dentist about all||
3043|107|P|the products you use (including prescription drugs,||
3043|108|P|nonprescription drugs, and herbal products).||
3043|109|P|   Older adults may be more sensitive to the side effects of this||
3043|110|P|drug, especially dizziness and water/mineral loss.||
3043|111|P|   During pregnancy, this medication should be used only when||
3043|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
3043|113|P|   It is unknown if this drug passes into breast milk. Consult||
3043|114|P|your doctor before breastfeeding.||
3043|115|B|||
3043|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3043|117|I|medications work or increase your risk for serious side effects.||
3043|118|I|This document does not contain all possible drug interactions.||
3043|119|I|Keep a list of all the products you use (including||
3043|120|I|prescription/nonprescription drugs and herbal products) and share||
3043|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
3043|122|I|the dosage of any medicines without your doctor's approval.||
3043|123|I|   Some products that may interact with this drug include:||
3043|124|I|desmopressin, furosemide, lithium.||
3043|125|I|   Some products have ingredients that could raise your blood||
3043|126|I|pressure or worsen your swelling. Tell your pharmacist what||
3043|127|I|products you are using, and ask how to use them safely||
3043|128|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
3043|129|I|ibuprofen/naproxen).||
3043|130|B|||
3043|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3043|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3043|133|O|poison control center right away. US residents can call||
3043|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3043|135|B|||
3043|136|N|NOTES:  Lab and/or medical tests (such as kidney function, blood||
3043|137|N|mineral levels such as potassium) should be done while you are||
3043|138|N|using this medication. Keep all medical and lab appointments.||
3043|139|B|||
3043|140|D|MISSED DOSE:  Not applicable.||
3043|141|B|||
3043|142|R|STORAGE:  Not applicable. This medication is given in a hospital||
3043|143|R|or clinic and will not be stored at home.||
3043|144|B|||
3043|145|A|Information last revised May 2024.||
3043|146|A|Copyright(c) 2025 First Databank, Inc.||
3043|147|B|||
3046|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3046|002|Z|does NOT have all possible information about this product. This||
3046|003|Z|information does not assure that this product is safe, effective,||
3046|004|Z|or appropriate for you. This information is not individual||
3046|005|Z|medical advice and does not substitute for the advice of your||
3046|006|Z|health care professional. Always ask your health care||
3046|007|Z|professional for complete information about this product and your||
3046|008|Z|specific health needs.||
3046|009|B|||
3046|010|T|HYDROXYUREA - ORAL||
3046|011|F|(hi-DROX-ee-you-REE-uh)||
3046|012|B|||
3046|013|C|COMMON BRAND NAME(S): Droxia, Hydrea, Siklos, Xromi||
3046|014|B|||
3046|015|W|WARNING:  This medication decreases bone marrow function, an||
3046|016|W|effect that may lead to a low number of blood cells such as red||
3046|017|W|cells, white cells, and platelets. This effect can cause anemia,||
3046|018|W|decrease your body's ability to fight an infection, or cause easy||
3046|019|W|bruising/bleeding. Your doctor will monitor you closely while you||
3046|020|W|are using this medication. Tell your doctor right away if you||
3046|021|W|develop any of the following symptoms: signs of infection (such||
3046|022|W|as sore throat that doesn't go away, fever, chills), easy||
3046|023|W|bruising/bleeding, pale skin, unusual tiredness.||
3046|024|W|   Hydroxyurea may cause other cancers (such as secondary||
3046|025|W|leukemia, skin cancer). Protect your skin from the sun. Avoid||
3046|026|W|prolonged sun exposure, tanning booths, and sunlamps. Use||
3046|027|W|sunscreen and wear protective clothing when outdoors. Tell your||
3046|028|W|doctor right away if you notice any symptoms of cancer, such as||
3046|029|W|swollen lymph nodes, sudden weight loss, night sweats, or unusual||
3046|030|W|skin growths/moles.||
3046|031|B|||
3046|032|U|USES:  This medication is used by people with sickle cell anemia||
3046|033|U|to reduce the number of painful crises caused by the disease and||
3046|034|U|to reduce the need for blood transfusions. Some brands are also||
3046|035|U|used to treat certain types of cancer (such as chronic||
3046|036|U|myelogenous leukemia, squamous cell carcinomas).||
3046|037|B|||
3046|038|V|OTHER USES:  This section contains uses of this drug that are not||
3046|039|V|listed in the approved professional labeling for the drug but||
3046|040|V|that may be prescribed by your health care professional. Use this||
3046|041|V|drug for a condition that is listed in this section only if it||
3046|042|V|has been so prescribed by your health care professional.||
3046|043|V|   This drug may also be used for polycythemia vera or||
3046|044|V|thrombocythemia.||
3046|045|B|||
3046|046|H|HOW TO USE:  Read the Medication Guide if available from your||
3046|047|H|pharmacist before you start taking hydroxyurea and each time you||
3046|048|H|get a refill. If you have any questions, ask your doctor or||
3046|049|H|pharmacist.||
3046|050|H|   Take this medication by mouth with or without food as directed||
3046|051|H|by your doctor, usually once daily. The dosage is based on your||
3046|052|H|weight, medical condition, lab results, and response to||
3046|053|H|treatment. Your treatment may be stopped for a short time if your||
3046|054|H|blood counts are too low. Keep all medical and lab appointments.||
3046|055|H|   Do not increase your dose or use this drug more often or for||
3046|056|H|longer than prescribed. Your condition will not improve any||
3046|057|H|faster, and your risk of serious side effects will increase.||
3046|058|H|   If you are using the capsules, swallow the them whole. Do not||
3046|059|H|crush, chew, or open the capsules.||
3046|060|H|   If you are using the tablets, swallow your dose with a glass||
3046|061|H|of water. Only split a tablet if it has a score line and your||
3046|062|H|doctor has instructed you to do so. If you have trouble||
3046|063|H|swallowing, you may dissolve the whole or split tablet in a small||
3046|064|H|amount of water in a teaspoon and swallow it right away.||
3046|065|H|   If you are using the liquid form of this medication, read the||
3046|066|H|Instructions for Use if available from your pharmacist before you||
3046|067|H|start using hydroxyurea and each time you get a refill. Do not||
3046|068|H|shake the medication. Carefully measure the dose using the||
3046|069|H|special measuring device that is provided. Do not use a household||
3046|070|H|spoon because you may not get the correct dose. After each dose,||
3046|071|H|drink some water to make sure all the dose is taken. Rinse the||
3046|072|H|syringe with water after each use. Consult your doctor or||
3046|073|H|pharmacist if you have any questions.||
3046|074|H|   Wash hands before and after handling the medication or its||
3046|075|H|container. You and/or your caregiver should wear disposable||
3046|076|H|gloves when handling this medication or its container. If this||
3046|077|H|medication spills, wipe it up right away with a wet paper towel||
3046|078|H|and throw away in a closed container such as a plastic bag. Clean||
3046|079|H|the spill area right away with soap and water. Make sure not to||
3046|080|H|breathe the powder from the tablets/capsules.||
3046|081|H|   Since this drug can be absorbed through the skin and lungs,||
3046|082|H|women who are pregnant or who may become pregnant should not||
3046|083|H|handle this medication or breathe the dust from the||
3046|084|H|tablets/capsules.||
3046|085|H|   Tell your doctor if your condition does not get better or if||
3046|086|H|it gets worse.||
3046|087|B|||
3046|088|S|SIDE EFFECTS:  See also Warning Section.||
3046|089|S|   Nausea, vomiting, loss of appetite, mouth sores, diarrhea, or||
3046|090|S|constipation may occur. If any of these effects last or get||
3046|091|S|worse, tell your doctor or pharmacist promptly.||
3046|092|S|   People using this medication may have serious side effects.||
3046|093|S|However, you have been prescribed this drug because your doctor||
3046|094|S|has judged that the benefit to you is greater than the risk of||
3046|095|S|side effects. Careful monitoring by your doctor may decrease your||
3046|096|S|risk.||
3046|097|S|   Tell your doctor right away if you have any serious side||
3046|098|S|effects, including: skin problems (such as ulcers,||
3046|099|S|darkened/blackened/reddened skin), mental/mood changes (such as||
3046|100|S|confusion, hallucinations), seizures, shortness of breath,||
3046|101|S|yellowing eyes/skin, dark/bloody urine, signs of kidney problems||
3046|102|S|(such as change in the amount of urine).||
3046|103|S|   Get medical help right away if you have any very serious side||
3046|104|S|effects, including: chest pain.||
3046|105|S|   A very serious allergic reaction to this drug is rare.||
3046|106|S|However, get medical help right away if you notice any symptoms||
3046|107|S|of a serious allergic reaction, including: rash, itching/swelling||
3046|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3046|109|S|breathing.||
3046|110|S|   This is not a complete list of possible side effects. If you||
3046|111|S|notice other effects not listed above, contact your doctor or||
3046|112|S|pharmacist.||
3046|113|S|   In the US -||
3046|114|S|   Call your doctor for medical advice about side effects. You||
3046|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3046|116|S|www.fda.gov/medwatch.||
3046|117|S|   In Canada - Call your doctor for medical advice about side||
3046|118|S|effects. You may report side effects to Health Canada at||
3046|119|S|1-866-234-2345.||
3046|120|B|||
3046|121|P|PRECAUTIONS:  See also Warning section.||
3046|122|P|   Before taking hydroxyurea, tell your doctor or pharmacist if||
3046|123|P|you are allergic to it; or if you have any other allergies. This||
3046|124|P|product may contain inactive ingredients, which can cause||
3046|125|P|allergic reactions or other problems. Talk to your pharmacist for||
3046|126|P|more details.||
3046|127|P|   Before using this medication, tell your doctor or pharmacist||
3046|128|P|your medical history, especially of: other blood/bone marrow||
3046|129|P|problems (such as low red/white blood cells and platelets),||
3046|130|P|kidney disease, liver disease, HIV infection, high uric acid||
3046|131|P|level in the blood, radiation treatment.||
3046|132|P|   Hydroxyurea can make you more likely to get infections or may||
3046|133|P|make current infections worse. Stay away from anyone who has an||
3046|134|P|infection that may easily spread (such as chickenpox, COVID-19,||
3046|135|P|measles, flu). Talk to your doctor if you have been exposed to an||
3046|136|P|infection or for more details.||
3046|137|P|   Tell your health care professional that you are using||
3046|138|P|hydroxyurea before having any immunizations/vaccinations. Avoid||
3046|139|P|contact with people who have recently received live vaccines||
3046|140|P|(such as flu vaccine inhaled through the nose).||
3046|141|P|   To lower the chance of getting cut, bruised, or injured, use||
3046|142|P|caution with sharp objects like razors and nail cutters, and||
3046|143|P|avoid activities such as contact sports.||
3046|144|P|   Before having surgery, tell your doctor or dentist about all||
3046|145|P|the products you use (including prescription drugs,||
3046|146|P|nonprescription drugs, and herbal products).||
3046|147|P|   Older adults may be more sensitive to the side effects of this||
3046|148|P|drug.||
3046|149|P|   It is unknown if this medication affects sperm. If you plan to||
3046|150|P|father a child, discuss the risks and benefits of this medication||
3046|151|P|with your doctor.||
3046|152|P|   Tell your doctor if you are pregnant or plan to become||
3046|153|P|pregnant. You should not become pregnant while using hydroxyurea.||
3046|154|P|Hydroxyurea may harm an unborn baby. Women using this medication||
3046|155|P|should ask about reliable forms of birth control during treatment||
3046|156|P|and for 6 months after the last dose. Men using this medication||
3046|157|P|should ask about reliable forms of birth control during treatment||
3046|158|P|and for 1 year after the last dose. If you or your partner||
3046|159|P|becomes pregnant, talk to your doctor right away about the risks||
3046|160|P|and benefits of this medication.||
3046|161|P|   Hydroxyurea passes into breast milk and may have undesirable||
3046|162|P|effects on a nursing infant. Breastfeeding is not recommended||
3046|163|P|while using this medication. Consult your doctor before||
3046|164|P|breastfeeding.||
3046|165|B|||
3046|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3046|167|I|medications work or increase your risk for serious side effects.||
3046|168|I|This document does not contain all possible drug interactions.||
3046|169|I|Keep a list of all the products you use (including||
3046|170|I|prescription/nonprescription drugs and herbal products) and share||
3046|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
3046|172|I|the dosage of any medicines without your doctor's approval.||
3046|173|I|   Some products that may interact with this drug include:||
3046|174|I|didanosine, stavudine.||
3046|175|I|   This medication may interfere with certain lab tests (such as||
3046|176|I|certain blood sugar tests), possibly causing false test results.||
3046|177|I|Make sure lab personnel and all your doctors know you use this||
3046|178|I|drug.||
3046|179|B|||
3046|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3046|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3046|182|O|poison control center right away. US residents can call||
3046|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3046|184|O|Symptoms of overdose include: swelling/scaling of hands and feet.||
3046|185|B|||
3046|186|N|NOTES:  Do not share this medication with others.||
3046|187|N|   Lab and/or medical tests (such as complete blood count,||
3046|188|N|kidney/liver function) must be done before you start taking this||
3046|189|N|medication and while you are taking it. Keep all medical and lab||
3046|190|N|appointments.||
3046|191|N|   Your doctor may direct you to also take folic acid while you||
3046|192|N|are taking hydroxyurea due to the risk of anemia. Ask your doctor||
3046|193|N|for details.||
3046|194|B|||
3046|195|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3046|196|D|remember. If it is near the time of the next dose, skip the||
3046|197|D|missed dose. Take your next dose at the regular time. Do not||
3046|198|D|double the dose to catch up.||
3046|199|B|||
3046|200|R|STORAGE:  Store tablets and capsules at room temperature away||
3046|201|R|from light and moisture. Do not store in the bathroom. Store the||
3046|202|R|liquid form in the refrigerator. Do not freeze. Once the liquid||
3046|203|R|bottle is opened, this medication expires after 12 weeks. Keep||
3046|204|R|all medications away from children and pets.||
3046|205|R|   Do not flush medications down the toilet or pour them into a||
3046|206|R|drain unless instructed to do so. Properly discard this product||
3046|207|R|when it is expired or no longer needed. Consult your pharmacist||
3046|208|R|or local waste disposal company.||
3046|209|B|||
3046|210|A|Information last revised May 2025.||
3046|211|A|Copyright(c) 2025 First Databank, Inc.||
3046|212|B|||
3047|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3047|002|Z|does NOT have all possible information about this product. This||
3047|003|Z|information does not assure that this product is safe, effective,||
3047|004|Z|or appropriate for you. This information is not individual||
3047|005|Z|medical advice and does not substitute for the advice of your||
3047|006|Z|health care professional. Always ask your health care||
3047|007|Z|professional for complete information about this product and your||
3047|008|Z|specific health needs.||
3047|009|B|||
3047|010|T|CITALOPRAM - ORAL||
3047|011|F|(sye-TAL-oh-pram)||
3047|012|B|||
3047|013|C|COMMON BRAND NAME(S): Celexa||
3047|014|B|||
3047|015|W|WARNING:  Antidepressant medications are used to treat a variety||
3047|016|W|of conditions, including depression and other mental/mood||
3047|017|W|disorders. These medications can help prevent suicidal||
3047|018|W|thoughts/attempts and provide other important benefits. However,||
3047|019|W|studies have shown that a small number of people (especially||
3047|020|W|people younger than 25) who take antidepressants for any||
3047|021|W|condition may experience worsening depression, other mental/mood||
3047|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
3047|023|W|talk with the doctor about the risks and benefits of||
3047|024|W|antidepressant medication (especially for people younger than||
3047|025|W|25), even if treatment is not for a mental/mood condition.||
3047|026|W|   Tell the doctor right away if you notice worsening||
3047|027|W|depression/other psychiatric conditions, unusual behavior changes||
3047|028|W|(including possible suicidal thoughts/attempts), or other||
3047|029|W|mental/mood changes (including new/worsening anxiety, panic||
3047|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
3047|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
3047|032|W|especially watchful for these symptoms when a new antidepressant||
3047|033|W|is started or when the dose is changed.||
3047|034|B|||
3047|035|U|USES:  This medication is used to treat depression. Citalopram||
3047|036|U|belongs to a class of drugs known as selective serotonin reuptake||
3047|037|U|inhibitors (SSRIs). It works by helping to restore the balance of||
3047|038|U|a certain natural substance (serotonin) in the brain.||
3047|039|B|||
3047|040|V|OTHER USES:  This section contains uses of this drug that are not||
3047|041|V|listed in the approved professional labeling for the drug but||
3047|042|V|that may be prescribed by your health care professional. Use this||
3047|043|V|drug for a condition that is listed in this section only if it||
3047|044|V|has been so prescribed by your health care professional.||
3047|045|V|   This drug may also be used for other mental conditions (such||
3047|046|V|as obsessive-compulsive disorder, panic disorder) or binge eating||
3047|047|V|disorder (BED). It may also be used for hot flashes that occur||
3047|048|V|with menopause.||
3047|049|B|||
3047|050|H|HOW TO USE:  Read the Medication Guide and, if available, the||
3047|051|H|Patient Information Leaflet provided by your pharmacist before||
3047|052|H|you start taking citalopram and each time you get a refill. If||
3047|053|H|you have any questions, ask your doctor or pharmacist.||
3047|054|H|   Take this medication with or without food as directed by your||
3047|055|H|doctor, usually once daily in the morning or evening. The dosage||
3047|056|H|is based on your medical condition, response to treatment, age,||
3047|057|H|lab tests, and other medications you may be taking. Be sure to||
3047|058|H|tell your doctor and pharmacist about all the products you use||
3047|059|H|(including prescription drugs, nonprescription drugs, and herbal||
3047|060|H|products).||
3047|061|H|   If you are using the liquid form of this medication, carefully||
3047|062|H|measure the dose using a special measuring device/spoon. Do not||
3047|063|H|use a household spoon because you may not get the correct dose.||
3047|064|H|   To reduce your risk of side effects, your doctor may direct||
3047|065|H|you to start taking this drug at a low dose and gradually||
3047|066|H|increase your dose. Follow your doctor's instructions carefully.||
3047|067|H|Do not increase your dose or use this drug more often or for||
3047|068|H|longer than prescribed. Your condition will not improve any||
3047|069|H|faster, and your risk of side effects will increase. Take this||
3047|070|H|medication regularly to get the most benefit from it. To help you||
3047|071|H|remember, take it at the same time each day.||
3047|072|H|   Keep taking this medication even if you feel well. Do not stop||
3047|073|H|taking this medication without consulting your doctor. Some||
3047|074|H|conditions may become worse when this drug is suddenly stopped.||
3047|075|H|Also, you may experience symptoms such as mood swings, headache,||
3047|076|H|tiredness, sleep changes, and brief feelings similar to electric||
3047|077|H|shock. To prevent these symptoms while you are stopping treatment||
3047|078|H|with this drug, your doctor may reduce your dose gradually.||
3047|079|H|Consult your doctor or pharmacist for more details. Report any||
3047|080|H|new or worsening symptoms right away.||
3047|081|H|   It may take 1 to 4 weeks to feel a benefit from this drug and||
3047|082|H|up to several weeks before you get the full benefit.||
3047|083|H|   Tell your doctor if your condition does not get better or if||
3047|084|H|it gets worse.||
3047|085|B|||
3047|086|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
3047|087|S|   Nausea, dry mouth, loss of appetite, tiredness, drowsiness,||
3047|088|S|sweating, blurred vision, and yawning may occur. If any of these||
3047|089|S|effects last or get worse, tell your doctor or pharmacist||
3047|090|S|promptly.||
3047|091|S|   Remember that this medication has been prescribed because your||
3047|092|S|doctor has judged that the benefit to you is greater than the||
3047|093|S|risk of side effects. Many people using this medication do not||
3047|094|S|have serious side effects.||
3047|095|S|   Tell your doctor right away if you have any serious side||
3047|096|S|effects, including: shaking (tremor), decreased interest in sex,||
3047|097|S|changes in sexual ability, easy bleeding/bruising.||
3047|098|S|   Get medical help right away if you have any very serious side||
3047|099|S|effects, including: fainting, fast/irregular heartbeat, black||
3047|100|S|stools, vomit that looks like coffee grounds, seizures, eye||
3047|101|S|pain/swelling/redness, widened pupils, vision changes (such as||
3047|102|S|seeing rainbows around lights at night).||
3047|103|S|   This medication may increase serotonin and rarely cause a very||
3047|104|S|serious condition called serotonin syndrome/toxicity. The risk||
3047|105|S|increases if you are also taking other drugs that increase||
3047|106|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
3047|107|S|take (see Drug Interactions section). Get medical help right away||
3047|108|S|if you develop some of the following symptoms: fast heartbeat,||
3047|109|S|hallucinations, loss of coordination, severe dizziness, severe||
3047|110|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
3047|111|S|unusual agitation/restlessness.||
3047|112|S|   Rarely, males may have a painful or prolonged erection lasting||
3047|113|S|4 or more hours. If this occurs, stop using this drug and get||
3047|114|S|medical help right away, or permanent problems could occur.||
3047|115|S|   A very serious allergic reaction to this drug is rare.||
3047|116|S|However, get medical help right away if you notice any symptoms||
3047|117|S|of a serious allergic reaction, including: rash, itching/swelling||
3047|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3047|119|S|breathing.||
3047|120|S|   This is not a complete list of possible side effects. If you||
3047|121|S|notice other effects not listed above, contact your doctor or||
3047|122|S|pharmacist.||
3047|123|S|   In the US -||
3047|124|S|   Call your doctor for medical advice about side effects. You||
3047|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3047|126|S|www.fda.gov/medwatch.||
3047|127|S|   In Canada - Call your doctor for medical advice about side||
3047|128|S|effects. You may report side effects to Health Canada at||
3047|129|S|1-866-234-2345.||
3047|130|B|||
3047|131|P|PRECAUTIONS:  Before taking citalopram, tell your doctor or||
3047|132|P|pharmacist if you are allergic to it; or to escitalopram; or if||
3047|133|P|you have any other allergies. This product may contain inactive||
3047|134|P|ingredients, which can cause allergic reactions or other||
3047|135|P|problems. Talk to your pharmacist for more details.||
3047|136|P|   Before using this medication, tell your doctor or pharmacist||
3047|137|P|your medical history, especially of: personal or family history||
3047|138|P|of bipolar/manic-depressive disorder, personal or family history||
3047|139|P|of suicide attempts, liver disease, seizures, low sodium in the||
3047|140|P|blood, bleeding problems, personal or family history of glaucoma||
3047|141|P|(angle-closure type).||
3047|142|P|   Citalopram may cause a condition that affects the heart rhythm||
3047|143|P|(QT prolongation). QT prolongation can rarely cause serious||
3047|144|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
3047|145|P|as severe dizziness, fainting) that need medical attention right||
3047|146|P|away.||
3047|147|P|   The risk of QT prolongation may be increased if you have||
3047|148|P|certain medical conditions or are taking other drugs that may||
3047|149|P|cause QT prolongation. Before using citalopram, tell your doctor||
3047|150|P|or pharmacist of all the drugs you take and if you have any of||
3047|151|P|the following conditions: certain heart problems (heart failure,||
3047|152|P|slow heartbeat, recent heart attack, QT prolongation in the EKG),||
3047|153|P|family history of certain heart problems (QT prolongation in the||
3047|154|P|EKG, sudden cardiac death).||
3047|155|P|   Low levels of potassium or magnesium in the blood may also||
3047|156|P|increase your risk of QT prolongation. This risk may increase if||
3047|157|P|you use certain drugs (such as diuretics/"water pills") or if you||
3047|158|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3047|159|P|Talk to your doctor about using citalopram safely.||
3047|160|P|   This drug may make you drowsy or blur your vision. Alcohol or||
3047|161|P|marijuana (cannabis) can make you more drowsy. Do not drive, use||
3047|162|P|machinery, or do anything that needs alertness or clear vision||
3047|163|P|until you can do it safely. Avoid alcoholic beverages. Talk to||
3047|164|P|your doctor if you are using marijuana (cannabis).||
3047|165|P|   Before having surgery, tell your doctor or dentist about all||
3047|166|P|the products you use (including prescription drugs,||
3047|167|P|nonprescription drugs, and herbal products).||
3047|168|P|   Older adults may be more sensitive to the side effects of this||
3047|169|P|drug, especially bleeding, loss of coordination, and QT||
3047|170|P|prolongation (see above). They may also be more likely to develop||
3047|171|P|a type of salt imbalance (hyponatremia), especially if they are||
3047|172|P|also taking "water pills" (diuretics). Loss of coordination can||
3047|173|P|increase the risk of falling.||
3047|174|P|   Children may be more sensitive to the side effects of this||
3047|175|P|drug, especially loss of appetite and weight loss. Monitor weight||
3047|176|P|and height in children who are taking this drug.||
3047|177|P|   During pregnancy, this medication should be used only when||
3047|178|P|clearly needed. It may harm an unborn baby. Also, babies born to||
3047|179|P|mothers who have used this drug during the last 3 months of||
3047|180|P|pregnancy may rarely develop withdrawal symptoms such as||
3047|181|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
3047|182|P|constant crying. If you notice any of these symptoms in your||
3047|183|P|newborn, tell the doctor promptly.||
3047|184|P|   Since untreated mental/mood problems (such as depression,||
3047|185|P|obsessive-compulsive disorder, panic disorder) can be a serious||
3047|186|P|condition, do not stop taking this medication unless directed by||
3047|187|P|your doctor. If you are planning pregnancy, become pregnant, or||
3047|188|P|think you may be pregnant, immediately discuss with your doctor||
3047|189|P|the benefits and risks of using this medication during pregnancy.||
3047|190|P|   This drug passes into breast milk and may have undesirable||
3047|191|P|effects on a nursing infant. Consult your doctor before||
3047|192|P|breastfeeding.||
3047|193|B|||
3047|194|I|DRUG INTERACTIONS:  See also Precautions section.||
3047|195|I|   Drug interactions may change how your medications work or||
3047|196|I|increase your risk for serious side effects. This document does||
3047|197|I|not contain all possible drug interactions. Keep a list of all||
3047|198|I|the products you use (including prescription/nonprescription||
3047|199|I|drugs and herbal products) and share it with your doctor and||
3047|200|I|pharmacist. Do not start, stop, or change the dosage of any||
3047|201|I|medicines without your doctor's approval.||
3047|202|I|   Some products that may interact with this drug are: other||
3047|203|I|drugs that can cause bleeding/bruising (including antiplatelet||
3047|204|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
3047|205|I|"blood thinners" such as dabigatran/warfarin).||
3047|206|I|   Aspirin can increase the risk of bleeding when used with this||
3047|207|I|medication. However, if your doctor has told you to take low-dose||
3047|208|I|aspirin to prevent heart attack or stroke (usually 81-162||
3047|209|I|milligrams a day), you should keep taking the aspirin unless your||
3047|210|I|doctor tells you not to. Ask your doctor or pharmacist for more||
3047|211|I|details.||
3047|212|I|   Taking MAO inhibitors with this medication may cause a serious||
3047|213|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
3047|214|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
3047|215|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
3047|216|I|selegiline, tranylcypromine) during treatment with this||
3047|217|I|medication. Most MAO inhibitors should also not be taken for two||
3047|218|I|weeks before and after treatment with this medication. Ask your||
3047|219|I|doctor when to start or stop taking this medication.||
3047|220|I|   The risk of serotonin syndrome/toxicity increases if you are||
3047|221|I|also taking other drugs that increase serotonin. Examples include||
3047|222|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
3047|223|I|antidepressants (including other SSRIs such as||
3047|224|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
3047|225|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
3047|226|I|may be more likely when you start or increase the dose of these||
3047|227|I|drugs.||
3047|228|I|   Tell your doctor or pharmacist if you are taking other||
3047|229|I|products that cause drowsiness including alcohol, marijuana||
3047|230|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
3047|231|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
3047|232|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
3047|233|I|codeine).||
3047|234|I|   Check the labels on all your medicines (such as allergy or||
3047|235|I|cough-and-cold products) because they may contain ingredients||
3047|236|I|that cause drowsiness. Ask your pharmacist about using those||
3047|237|I|products safely.||
3047|238|I|   Many drugs besides citalopram may affect the heart rhythm (QT||
3047|239|I|prolongation), including amiodarone, pimozide, procainamide,||
3047|240|I|quinidine, sotalol, among others.||
3047|241|I|   Citalopram is very similar to escitalopram. Do not use||
3047|242|I|medications containing escitalopram while using citalopram.||
3047|243|I|   This medication may interfere with certain medical/lab tests||
3047|244|I|(such as brain scan for Parkinson's disease), possibly causing||
3047|245|I|false test results. Make sure lab personnel and all your doctors||
3047|246|I|know you use this drug.||
3047|247|B|||
3047|248|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3047|249|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3047|250|O|poison control center right away. US residents can call||
3047|251|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3047|252|B|||
3047|253|N|NOTES:  Do not share this medication with others.||
3047|254|N|   Lab and/or medical tests (such as EKG) should be done while||
3047|255|N|you are taking this medication. Keep all medical and lab||
3047|256|N|appointments. Consult your doctor for more details.||
3047|257|B|||
3047|258|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3047|259|D|remember. If it is near the time of the next dose, skip the||
3047|260|D|missed dose. Take your next dose at the regular time. Do not||
3047|261|D|double the dose to catch up.||
3047|262|B|||
3047|263|R|STORAGE:  Store at room temperature away from light and moisture.||
3047|264|R|Do not store in the bathroom. Keep all medications away from||
3047|265|R|children and pets.||
3047|266|R|   Do not flush medications down the toilet or pour them into a||
3047|267|R|drain unless instructed to do so. Properly discard this product||
3047|268|R|when it is expired or no longer needed. Consult your pharmacist||
3047|269|R|or local waste disposal company.||
3047|270|B|||
3047|271|A|Information last revised October 2024.||
3047|272|A|Copyright(c) 2025 First Databank, Inc.||
3047|273|B|||
3049|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3049|002|Z|does NOT have all possible information about this product. This||
3049|003|Z|information does not assure that this product is safe, effective,||
3049|004|Z|or appropriate for you. This information is not individual||
3049|005|Z|medical advice and does not substitute for the advice of your||
3049|006|Z|health care professional. Always ask your health care||
3049|007|Z|professional for complete information about this product and your||
3049|008|Z|specific health needs.||
3049|009|B|||
3049|010|T|KETOROLAC - ORAL||
3049|011|F|(KEE-toe-ROLE-ak)||
3049|012|B|||
3049|013|C|COMMON BRAND NAME(S): Toradol||
3049|014|B|||
3049|015|W|WARNING:  It is important that you use this medication properly||
3049|016|W|to help reduce your risk of side effects. Your doctor may adjust||
3049|017|W|your dose if you are older, have low body weight, or have kidney||
3049|018|W|problems.||
3049|019|W|   Nonsteroidal anti-inflammatory drugs (including ketorolac) may||
3049|020|W|rarely increase the risk for a heart attack or stroke. This||
3049|021|W|effect can happen at any time while taking this drug but is more||
3049|022|W|likely if you take it for a long time. The risk may be greater in||
3049|023|W|older adults or if you have heart disease or increased risk for||
3049|024|W|heart disease (for example, due to smoking, family history of||
3049|025|W|heart disease, or conditions such as high blood pressure or||
3049|026|W|diabetes). Talk to your doctor about the benefits and risks of||
3049|027|W|taking this drug.||
3049|028|W|   This drug may rarely cause serious (rarely fatal) bleeding||
3049|029|W|from the stomach or intestines. This effect can occur without||
3049|030|W|warning at any time while taking this drug. Older adults may be||
3049|031|W|at higher risk for this effect. Do not use this medication if you||
3049|032|W|have stomach/intestinal problems (such as bleeding, ulcers).||
3049|033|W|   Stop using ketorolac and get medical help right away if you||
3049|034|W|notice any of the following rare but serious side effects:||
3049|035|W|stomach/abdominal pain that doesn't go away, bloody or||
3049|036|W|black/tarry stools, vomit that looks like coffee grounds,||
3049|037|W|chest/jaw/left arm pain, shortness of breath, unusual sweating,||
3049|038|W|weakness on one side of the body, sudden vision changes, trouble||
3049|039|W|speaking.||
3049|040|W|   Do not take this drug right before or after heart bypass||
3049|041|W|surgery (CABG) or before any surgery. It also should not be used||
3049|042|W|during labor/delivery or in people with severe kidney problems or||
3049|043|W|high risk for kidney problems. Do not use ketorolac if you are||
3049|044|W|taking high doses of aspirin or other nonsteroidal||
3049|045|W|anti-inflammatory drugs (NSAIDs). See also Drug Interactions||
3049|046|W|section.||
3049|047|B|||
3049|048|U|USES:  Ketorolac is used for the short-term treatment of moderate||
3049|049|U|to severe pain in adults. It is usually used before or after||
3049|050|U|medical procedures or after surgery. Reducing pain helps you||
3049|051|U|recover more comfortably so that you can return to your normal||
3049|052|U|daily activities. This medication is a nonsteroidal||
3049|053|U|anti-inflammatory drug (NSAID). It works by blocking your body's||
3049|054|U|production of certain natural substances that cause inflammation.||
3049|055|U|This effect helps to decrease swelling, pain, or fever.||
3049|056|U|   Ketorolac should not be used for mild or long-term painful||
3049|057|U|conditions (such as arthritis).||
3049|058|B|||
3049|059|H|HOW TO USE:  Read the Medication Guide and, if available, the||
3049|060|H|Patient Information Leaflet provided by your pharmacist before||
3049|061|H|you start taking ketorolac and each time you get a refill. If you||
3049|062|H|have any questions, ask your doctor or pharmacist.||
3049|063|H|   Take this medication by mouth as directed by your doctor,||
3049|064|H|usually every 4 to 6 hours with a full glass of water (8 ounces||
3049|065|H|or 240 milliliters). Do not lie down for at least 10 minutes||
3049|066|H|after taking this drug. If stomach upset occurs while taking this||
3049|067|H|medication, take it with food, milk, or an antacid.||
3049|068|H|   Dosage is based on your medical condition and response to||
3049|069|H|treatment. To reduce your risk of stomach bleeding and other side||
3049|070|H|effects, take this medication at the lowest effective dose for||
3049|071|H|the shortest possible time. Do not increase your dose, take it||
3049|072|H|more often, or take it for longer than 5 days. If you still have||
3049|073|H|pain after 5 days, talk with your doctor about other medications||
3049|074|H|you may use. Do not take more than 40 milligrams in a 24-hour||
3049|075|H|period.||
3049|076|H|   If you are taking this drug "as needed" (not on a regular||
3049|077|H|schedule), remember that pain medications work best if they are||
3049|078|H|used as the first signs of pain occur. If you wait until the pain||
3049|079|H|has worsened, the medicine may not work as well.||
3049|080|H|   Tell your doctor if your condition gets worse or if your pain||
3049|081|H|is not relieved.||
3049|082|B|||
3049|083|S|SIDE EFFECTS:  See also Warning section.||
3049|084|S|   Upset stomach, nausea, vomiting, constipation, diarrhea, gas,||
3049|085|S|dizziness, or drowsiness may occur. If any of these effects last||
3049|086|S|or get worse, tell your doctor or pharmacist promptly.||
3049|087|S|   Remember that this medication has been prescribed because your||
3049|088|S|doctor has judged that the benefit to you is greater than the||
3049|089|S|risk of side effects. Many people using this medication do not||
3049|090|S|have serious side effects.||
3049|091|S|   This medication may raise your blood pressure. Check your||
3049|092|S|blood pressure regularly and tell your doctor if the results are||
3049|093|S|high.||
3049|094|S|   Tell your doctor right away if you have any serious side||
3049|095|S|effects, including: fainting, fast/pounding heartbeat, hearing||
3049|096|S|changes (such as ringing in the ears), mental/mood changes (such||
3049|097|S|as confusion, depression), vision changes (such as blurred||
3049|098|S|vision), symptoms of heart failure (such as swelling ankles/feet,||
3049|099|S|unusual tiredness, unusual/sudden weight gain), easy||
3049|100|S|bruising/bleeding, signs of kidney problems (such as change in||
3049|101|S|the amount of urine).||
3049|102|S|   This drug may rarely cause serious (possibly fatal) liver||
3049|103|S|disease. Get medical help right away if you have any symptoms of||
3049|104|S|liver damage, including: nausea/vomiting that doesn't stop, dark||
3049|105|S|urine, stomach/abdominal pain, yellowing eyes/skin.||
3049|106|S|   A very serious allergic reaction to this drug is rare.||
3049|107|S|However, get medical help right away if you notice any symptoms||
3049|108|S|of a serious allergic reaction, including: fever, swollen lymph||
3049|109|S|nodes, rash, itching/swelling (especially of the||
3049|110|S|face/tongue/throat), severe dizziness, trouble breathing.||
3049|111|S|   This is not a complete list of possible side effects. If you||
3049|112|S|notice other effects not listed above, contact your doctor or||
3049|113|S|pharmacist.||
3049|114|S|   In the US -||
3049|115|S|   Call your doctor for medical advice about side effects. You||
3049|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3049|117|S|www.fda.gov/medwatch.||
3049|118|S|   In Canada - Call your doctor for medical advice about side||
3049|119|S|effects. You may report side effects to Health Canada at||
3049|120|S|1-866-234-2345.||
3049|121|B|||
3049|122|P|PRECAUTIONS:  Before taking ketorolac, tell your doctor or||
3049|123|P|pharmacist if you are allergic to it; or to aspirin or other||
3049|124|P|nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen,||
3049|125|P|naproxen, celecoxib); or if you have any other allergies. This||
3049|126|P|product may contain inactive ingredients, which can cause||
3049|127|P|allergic reactions or other problems. Talk to your pharmacist for||
3049|128|P|more details.||
3049|129|P|   Before taking this medication, tell your doctor or pharmacist||
3049|130|P|your medical history, especially of: asthma (including a history||
3049|131|P|of worsening breathing after taking aspirin or other NSAIDs),||
3049|132|P|bleeding or clotting problems, blood disorders (such as anemia),||
3049|133|P|heart disease (such as previous heart attack), high blood||
3049|134|P|pressure, liver disease, growths in the nose (nasal polyps),||
3049|135|P|throat/stomach/intestinal problems (such as bleeding, heartburn,||
3049|136|P|ulcers), stroke, swelling of the ankles/feet/hands.||
3049|137|P|   Kidney problems can sometimes occur with the use of NSAID||
3049|138|P|medications, including ketorolac. Problems are more likely to||
3049|139|P|occur if you are dehydrated, have heart failure or kidney||
3049|140|P|disease, are an older adult, or if you take certain medications||
3049|141|P|(see also Drug Interactions section). Drink plenty of fluids as||
3049|142|P|directed by your doctor to prevent dehydration and tell your||
3049|143|P|doctor right away if you have a change in the amount of urine.||
3049|144|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3049|145|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3049|146|P|machinery, or do anything that needs alertness until you can do||
3049|147|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
3049|148|P|are using marijuana (cannabis).||
3049|149|P|   This medicine may cause stomach/intestinal bleeding. Daily use||
3049|150|P|of alcohol and tobacco, especially when combined with this||
3049|151|P|medicine, may increase your risk for stomach bleeding. Limit||
3049|152|P|alcohol and stop smoking. Consult your doctor or pharmacist for||
3049|153|P|more information.||
3049|154|P|   This medication may make you more sensitive to the sun. Limit||
3049|155|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
3049|156|P|sunscreen and wear protective clothing when outdoors. Tell your||
3049|157|P|doctor right away if you get sunburned or have skin||
3049|158|P|blisters/redness.||
3049|159|P|   Before having surgery, tell your doctor or dentist about all||
3049|160|P|the products you use (including prescription drugs,||
3049|161|P|nonprescription drugs, and herbal products).||
3049|162|P|   Older adults may be more sensitive to the effects of the drug,||
3049|163|P|especially bleeding in the stomach/intestines, kidney problems,||
3049|164|P|heart attack, and stroke. Using high doses for a long time may||
3049|165|P|increase this risk.||
3049|166|P|   Before using this medication, women of childbearing age should||
3049|167|P|talk with their doctor(s) about the benefits and risks. Tell your||
3049|168|P|doctor if you are pregnant or if you plan to become pregnant.||
3049|169|P|This medication may harm an unborn baby and cause problems with||
3049|170|P|normal labor/delivery. It is not recommended for use in pregnancy||
3049|171|P|from 20 weeks until delivery. If your doctor decides that you||
3049|172|P|need to use this medication between 20 and 30 weeks of pregnancy,||
3049|173|P|you should use the lowest effective dose for the shortest||
3049|174|P|possible time. You should not use this medication after 30 weeks||
3049|175|P|of pregnancy.||
3049|176|P|   This medication passes into breast milk. Consult your doctor||
3049|177|P|before breastfeeding.||
3049|178|B|||
3049|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3049|180|I|medications work or increase your risk for serious side effects.||
3049|181|I|This document does not contain all possible drug interactions.||
3049|182|I|Keep a list of all the products you use (including||
3049|183|I|prescription/nonprescription drugs and herbal products) and share||
3049|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
3049|185|I|the dosage of any medicines without your doctor's approval.||
3049|186|I|   Some products that may interact with this drug include:||
3049|187|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
3049|188|I|angiotensin II receptor blockers (such as losartan, valsartan),||
3049|189|I|lithium, methotrexate, corticosteroids (such as prednisone),||
3049|190|I|other medications that may affect the kidneys (including||
3049|191|I|cidofovir, "water pills"/diuretics such as furosemide).||
3049|192|I|   Other medications can affect the removal of ketorolac from||
3049|193|I|your body, which may affect how ketorolac works. Examples include||
3049|194|I|cabotegravir, leflunomide, nitisinone, probenecid, teriflunomide,||
3049|195|I|vadadustat, among others.||
3049|196|I|   This medication may increase the risk of bleeding when taken||
3049|197|I|with other drugs that also may cause bleeding. Examples include||
3049|198|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
3049|199|I|dabigatran/enoxaparin/warfarin, among others.||
3049|200|I|   Check all prescription and nonprescription medicine labels||
3049|201|I|carefully since many medications contain pain relievers/fever||
3049|202|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These||
3049|203|I|drugs are similar to ketorolac and may increase your risk of side||
3049|204|I|effects if taken together. However, if your doctor has told you||
3049|205|I|to take low-dose aspirin to prevent heart attack or stroke||
3049|206|I|(usually 81-162 milligrams a day), you should keep taking the||
3049|207|I|aspirin unless your doctor tells you not to. Ask your doctor or||
3049|208|I|pharmacist for more details.||
3049|209|B|||
3049|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3049|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3049|212|O|poison control center right away. US residents can call||
3049|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3049|214|O|Symptoms of overdose may include: severe stomach pain, vomit that||
3049|215|O|looks like coffee grounds, extreme drowsiness, slow/shallow||
3049|216|O|breathing.||
3049|217|B|||
3049|218|N|NOTES:  Do not share this medication with others.||
3049|219|N|   Lab and/or medical tests (including blood pressure, kidney||
3049|220|N|function) may be done while you are taking this medication. Keep||
3049|221|N|all medical and lab appointments. Consult your doctor for more||
3049|222|N|details.||
3049|223|N|   This medication has been prescribed for your current condition||
3049|224|N|only. Do not use it later for another condition unless your||
3049|225|N|doctor directs you to do so. A different medication may be||
3049|226|N|necessary in that case.||
3049|227|B|||
3049|228|D|MISSED DOSE:  If you are taking this medication on a regular||
3049|229|D|schedule (not just "as needed") and you miss a dose, take it as||
3049|230|D|soon as you remember. If it is near the time of the next dose,||
3049|231|D|skip the missed dose. Take your next dose at the regular time. Do||
3049|232|D|not double the dose to catch up.||
3049|233|B|||
3049|234|R|STORAGE:  Store at room temperature away from light and moisture.||
3049|235|R|Do not store in the bathroom. Keep all medications away from||
3049|236|R|children and pets.||
3049|237|R|   Do not flush medications down the toilet or pour them into a||
3049|238|R|drain unless instructed to do so. Properly discard this product||
3049|239|R|when it is expired or no longer needed. Consult your pharmacist||
3049|240|R|or local waste disposal company.||
3049|241|B|||
3049|242|A|Information last revised July 2025.||
3049|243|A|Copyright(c) 2025 First Databank, Inc.||
3049|244|B|||
3050|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3050|002|Z|does NOT have all possible information about this product. This||
3050|003|Z|information does not assure that this product is safe, effective,||
3050|004|Z|or appropriate for you. This information is not individual||
3050|005|Z|medical advice and does not substitute for the advice of your||
3050|006|Z|health care professional. Always ask your health care||
3050|007|Z|professional for complete information about this product and your||
3050|008|Z|specific health needs.||
3050|009|B|||
3050|010|T|PIPERACILLIN/TAZOBACTAM - INJECTION||
3050|011|F|(PI-per-a-SIL-in/TAZ-oh-BAK-tam)||
3050|012|B|||
3050|013|C|COMMON BRAND NAME(S): Zosyn||
3050|014|B|||
3050|015|U|USES:  Piperacillin/tazobactam is used to treat a wide variety of||
3050|016|U|bacterial infections. It is a penicillin antibiotic. It works by||
3050|017|U|stopping the growth of bacteria.||
3050|018|B|||
3050|019|H|HOW TO USE:  This medication is given by injection into a vein as||
3050|020|H|directed by your doctor, usually every 6 hours. It should be||
3050|021|H|injected slowly over at least 30 minutes. The dosage is based on||
3050|022|H|your medical condition and response to treatment. Children's||
3050|023|H|dosage is also based on age and weight.||
3050|024|H|   If you are using this medication at home, learn all||
3050|025|H|preparation and usage instructions from your health care||
3050|026|H|professional. Before using, check this product for particles or||
3050|027|H|discoloration. If either is present, do not use the liquid. Learn||
3050|028|H|how to store and discard medical supplies safely.||
3050|029|H|   If you are using the frozen pre-mixed solution, thaw the||
3050|030|H|container at room temperature or in the refrigerator. If the bag||
3050|031|H|is thawed in the refrigerator, let it sit at room temperature for||
3050|032|H|at least 1 hour before using. Do not thaw by putting in warm/hot||
3050|033|H|water or microwaving. After thawing, shake well and squeeze the||
3050|034|H|container to check for leaks. Discard if the container leaks. Do||
3050|035|H|not re-freeze the solution after thawing.||
3050|036|H|   For the best effect, use this antibiotic at evenly spaced||
3050|037|H|times. To help you remember, use this medication at the same||
3050|038|H|time(s) every day.||
3050|039|H|   Continue to use this medication for the full time prescribed,||
3050|040|H|even if symptoms disappear after a few days. Stopping the||
3050|041|H|medication too early may result in a return of the infection.||
3050|042|H|   Tell your doctor if your condition lasts or gets worse.||
3050|043|B|||
3050|044|S|SIDE EFFECTS:  Nausea, constipation, diarrhea, headache, or||
3050|045|S|trouble sleeping may occur. If any of these effects last or get||
3050|046|S|worse, tell your doctor or pharmacist promptly.||
3050|047|S|   Remember that this medication has been prescribed because your||
3050|048|S|doctor has judged that the benefit to you is greater than the||
3050|049|S|risk of side effects. Many people using this medication do not||
3050|050|S|have serious side effects.||
3050|051|S|   Tell your doctor right away if you have any serious side||
3050|052|S|effects, including: easy bruising/bleeding, muscle||
3050|053|S|pain/tenderness/weakness.||
3050|054|S|   This medication may rarely cause a severe intestinal condition||
3050|055|S|due to a bacteria called C. difficile. This condition may occur||
3050|056|S|during treatment or weeks to months after treatment has stopped.||
3050|057|S|Tell your doctor right away if you develop: diarrhea that doesn't||
3050|058|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
3050|059|S|stool.||
3050|060|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
3050|061|S|products because they may make symptoms worse.||
3050|062|S|   Use of this medication for prolonged or repeated periods may||
3050|063|S|result in oral thrush or a new yeast infection. Contact your||
3050|064|S|doctor if you notice white patches in your mouth, a change in||
3050|065|S|vaginal discharge, or other new symptoms.||
3050|066|S|   Get medical help right away if you have any very serious side||
3050|067|S|effects, including: seizures, signs of kidney problems (such as a||
3050|068|S|change in the amount of urine).||
3050|069|S|   A very serious allergic reaction to this drug is rare.||
3050|070|S|However, get medical help right away if you notice any symptoms||
3050|071|S|of a serious allergic reaction, including: fever that doesn't go||
3050|072|S|away, new or worsening lymph node swelling, rash,||
3050|073|S|itching/swelling (especially of the face/tongue/throat), severe||
3050|074|S|dizziness, trouble breathing.||
3050|075|S|   This is not a complete list of possible side effects. If you||
3050|076|S|notice other effects not listed above, contact your doctor or||
3050|077|S|pharmacist.||
3050|078|S|   In the US -||
3050|079|S|   Call your doctor for medical advice about side effects. You||
3050|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3050|081|S|www.fda.gov/medwatch.||
3050|082|S|   In Canada - Call your doctor for medical advice about side||
3050|083|S|effects. You may report side effects to Health Canada at||
3050|084|S|1-866-234-2345.||
3050|085|B|||
3050|086|P|PRECAUTIONS:  Before using piperacillin/tazobactam, tell your||
3050|087|P|doctor or pharmacist if you are allergic to it; or to other||
3050|088|P|antibiotics (such as penicillins, cephalosporins); or if you have||
3050|089|P|any other allergies. This product may contain inactive||
3050|090|P|ingredients, which can cause allergic reactions or other||
3050|091|P|problems. Talk to your pharmacist for more details.||
3050|092|P|   Before using this medication, tell your doctor or pharmacist||
3050|093|P|your medical history, especially of: cystic fibrosis, kidney||
3050|094|P|disease, seizure disorder.||
3050|095|P|   This medication contains sodium. Consult your doctor or||
3050|096|P|pharmacist if you are on a salt-restricted diet or if you have a||
3050|097|P|condition that could be worsened by an increase in salt intake||
3050|098|P|(such as heart failure, high blood pressure).||
3050|099|P|   Piperacillin/tazobactam may cause live bacterial vaccines||
3050|100|P|(such as typhoid vaccine) to not work well. Tell your health care||
3050|101|P|professional that you are using piperacillin/tazobactam before||
3050|102|P|having any immunizations/vaccinations.||
3050|103|P|   Before having surgery, tell your doctor or dentist about all||
3050|104|P|the products you use (including prescription drugs,||
3050|105|P|nonprescription drugs, and herbal products).||
3050|106|P|   Older adults may be more sensitive to the extra sodium in this||
3050|107|P|medication.||
3050|108|P|   During pregnancy, this medication should be used only when||
3050|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
3050|110|P|   This medication passes into breast milk in small amounts.||
3050|111|P|Consult your doctor before breastfeeding.||
3050|112|B|||
3050|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3050|114|I|medications work or increase your risk for serious side effects.||
3050|115|I|This document does not contain all possible drug interactions.||
3050|116|I|Keep a list of all the products you use (including||
3050|117|I|prescription/nonprescription drugs and herbal products) and share||
3050|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
3050|119|I|the dosage of any medicines without your doctor's approval.||
3050|120|I|   One product that may interact with this drug is: methotrexate.||
3050|121|I|   This medication may interfere with certain lab tests||
3050|122|I|(including certain urine glucose tests), possibly causing false||
3050|123|I|test results. Make sure lab personnel and all your doctors know||
3050|124|I|you use this drug.||
3050|125|B|||
3050|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3050|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3050|128|O|poison control center right away. US residents can call||
3050|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3050|130|O|Symptoms of overdose may include: seizures.||
3050|131|B|||
3050|132|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
3050|133|N|sodium/potassium blood levels, kidney/liver function) should be||
3050|134|N|done while you are using this medication. Keep all medical and||
3050|135|N|lab appointments.||
3050|136|B|||
3050|137|D|MISSED DOSE:  It is important to get each dose of this medication||
3050|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
3050|139|D|right away for a new dosing schedule. Do not double the dose to||
3050|140|D|catch up.||
3050|141|B|||
3050|142|R|STORAGE:  Consult the product instructions or your pharmacist for||
3050|143|R|storage details. Keep all medications away from children and||
3050|144|R|pets.||
3050|145|R|   Do not flush medications down the toilet or pour them into a||
3050|146|R|drain unless instructed to do so. Properly discard this product||
3050|147|R|when it is expired or no longer needed. Consult your pharmacist||
3050|148|R|or local waste disposal company.||
3050|149|B|||
3050|150|A|Information last revised January 2025.||
3050|151|A|Copyright(c) 2025 First Databank, Inc.||
3050|152|B|||
3051|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3051|002|Z|does NOT have all possible information about this product. This||
3051|003|Z|information does not assure that this product is safe, effective,||
3051|004|Z|or appropriate for you. This information is not individual||
3051|005|Z|medical advice and does not substitute for the advice of your||
3051|006|Z|health care professional. Always ask your health care||
3051|007|Z|professional for complete information about this product and your||
3051|008|Z|specific health needs.||
3051|009|B|||
3051|010|T|RIZATRIPTAN TABLET - ORAL||
3051|011|F|(RYE-za-TRIP-tan)||
3051|012|B|||
3051|013|C|COMMON BRAND NAME(S): Maxalt||
3051|014|B|||
3051|015|U|USES:  Rizatriptan is used to treat migraines. It helps to||
3051|016|U|relieve headache, pain, and other migraine symptoms (including||
3051|017|U|nausea, vomiting, sensitivity to light/sound). Prompt treatment||
3051|018|U|helps you return to your normal routine and may decrease your||
3051|019|U|need for other pain medications. Rizatriptan belongs to a class||
3051|020|U|of drugs known as triptans. It affects a certain natural||
3051|021|U|substance (serotonin) that causes narrowing of blood vessels in||
3051|022|U|the brain. It may also relieve pain by affecting certain nerves||
3051|023|U|in the brain.||
3051|024|U|   Rizatriptan does not prevent future migraines or lessen how||
3051|025|U|often you get migraine attacks.||
3051|026|B|||
3051|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3051|028|H|from your pharmacist before you start taking rizatriptan and each||
3051|029|H|time you get a refill. If you have any questions, ask your doctor||
3051|030|H|or pharmacist.||
3051|031|H|   Take this medication by mouth as directed by your doctor, at||
3051|032|H|the first sign of a migraine. It may be taken with or without||
3051|033|H|food, but may work faster when it is taken on an empty stomach.||
3051|034|H|The dosage is based on your medical condition, age, response to||
3051|035|H|treatment, and other drugs you may be taking. Children's dosage||
3051|036|H|is also based on weight. Be sure to tell your doctor and||
3051|037|H|pharmacist about all the products you use (including prescription||
3051|038|H|drugs, nonprescription drugs, and herbal products).||
3051|039|H|   If there is no improvement in your symptoms, do not take more||
3051|040|H|doses of this medication before talking to your doctor. If your||
3051|041|H|symptoms are only partly relieved, or if your headache comes||
3051|042|H|back, adults may take another dose at least 2 hours after the||
3051|043|H|first dose. Children should not take more than one dose, or 5||
3051|044|H|milligrams in a 24-hour period. For adults, the US manufacturer||
3051|045|H|recommends a maximum dose of 30 milligrams in a 24-hour period.||
3051|046|H|The Canadian manufacturer recommends a maximum dose of 20||
3051|047|H|milligrams (for adults) in a 24-hour period.||
3051|048|H|   If you have a higher risk for heart problems (see||
3051|049|H|Precautions), your doctor may perform a heart exam before you||
3051|050|H|start taking rizatriptan. He/she may also direct you to take your||
3051|051|H|first dose of this medication in the office/clinic to monitor for||
3051|052|H|serious side effects (such as chest pain). Talk to your doctor||
3051|053|H|for details.||
3051|054|H|   If you are using drugs for migraine attacks on 10 or more days||
3051|055|H|each month, the drugs may actually make your headaches worse||
3051|056|H|(medication overuse headache). Do not use medications more often||
3051|057|H|or for longer than directed. Tell your doctor if you need to use||
3051|058|H|this medication more often, or if the medication is not working||
3051|059|H|as well, or if your headaches get worse.||
3051|060|B|||
3051|061|S|SIDE EFFECTS:  Flushing, feelings of||
3051|062|S|tingling/numbness/prickling/heat, tiredness, weakness,||
3051|063|S|drowsiness, or dizziness may occur. If any of these effects last||
3051|064|S|or get worse, tell your doctor or pharmacist promptly.||
3051|065|S|   Remember that this medication has been prescribed because your||
3051|066|S|doctor has judged that the benefit to you is greater than the||
3051|067|S|risk of side effects. Many people using this medication do not||
3051|068|S|have serious side effects.||
3051|069|S|   This medication may raise your blood pressure. Check your||
3051|070|S|blood pressure regularly and tell your doctor if the results are||
3051|071|S|high.||
3051|072|S|   Tell your doctor right away if you have any serious side||
3051|073|S|effects, including: blue fingers/toes/nails, cold hands/feet,||
3051|074|S|hearing changes, mental/mood changes.||
3051|075|S|   Rizatriptan can commonly cause chest/jaw/neck tightness, pain,||
3051|076|S|or pressure that is usually not serious. However, these side||
3051|077|S|effects are like symptoms of a heart attack, which may include||
3051|078|S|chest/jaw/left arm pain, shortness of breath, or unusual||
3051|079|S|sweating. Get medical help right away if these or other serious||
3051|080|S|side effects occur, including: fast/irregular heartbeat,||
3051|081|S|fainting, severe stomach/abdominal pain, bloody diarrhea, signs||
3051|082|S|of a stroke (such as weakness on one side of the body, trouble||
3051|083|S|speaking, sudden vision changes, confusion).||
3051|084|S|   This medication may increase serotonin and rarely cause a very||
3051|085|S|serious condition called serotonin syndrome/toxicity. The risk||
3051|086|S|increases if you are also taking other drugs that increase||
3051|087|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
3051|088|S|take (see Drug Interactions section). Get medical help right away||
3051|089|S|if you develop some of the following symptoms: fast heartbeat,||
3051|090|S|hallucinations, loss of coordination, severe dizziness, severe||
3051|091|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
3051|092|S|unusual agitation/restlessness.||
3051|093|S|   A very serious allergic reaction to this drug is rare.||
3051|094|S|However, get medical help right away if you notice any symptoms||
3051|095|S|of a serious allergic reaction, including: rash, itching/swelling||
3051|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3051|097|S|breathing.||
3051|098|S|   This is not a complete list of possible side effects. If you||
3051|099|S|notice other effects not listed above, contact your doctor or||
3051|100|S|pharmacist.||
3051|101|S|   In the US -||
3051|102|S|   Call your doctor for medical advice about side effects. You||
3051|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3051|104|S|www.fda.gov/medwatch.||
3051|105|S|   In Canada - Call your doctor for medical advice about side||
3051|106|S|effects. You may report side effects to Health Canada at||
3051|107|S|1-866-234-2345.||
3051|108|B|||
3051|109|P|PRECAUTIONS:  Before using rizatriptan, tell your doctor or||
3051|110|P|pharmacist if you are allergic to it; or if you have any other||
3051|111|P|allergies. This product may contain inactive ingredients, which||
3051|112|P|can cause allergic reactions or other problems. Talk to your||
3051|113|P|pharmacist for more details.||
3051|114|P|   Before using this medication, tell your doctor or pharmacist||
3051|115|P|your medical history, especially of: blood circulation problems||
3051|116|P|(for example, in your legs, arms/hands, or stomach), certain||
3051|117|P|types of headaches (hemiplegic or basilar migraine), heart||
3051|118|P|problems (such as chest pain, irregular heartbeat, previous heart||
3051|119|P|attack), liver disease, seizure, stroke or "mini-stroke"||
3051|120|P|(transient ischemic attack).||
3051|121|P|   Certain conditions can increase your risk for heart problems.||
3051|122|P|Tell your doctor if you have any of these conditions, including:||
3051|123|P|high blood pressure, high cholesterol, diabetes, family history||
3051|124|P|of heart disease, overweight, smoker, postmenopausal (women), age||
3051|125|P|more than 40 years (men).||
3051|126|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3051|127|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3051|128|P|machinery, or do anything that needs alertness until you can do||
3051|129|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
3051|130|P|are using marijuana (cannabis).||
3051|131|P|   Before having surgery, tell your doctor or dentist about all||
3051|132|P|the products you use (including prescription drugs,||
3051|133|P|nonprescription drugs, and herbal products).||
3051|134|P|   The risk of heart disease, liver disease, and high blood||
3051|135|P|pressure increases with age. Older adults may be more sensitive||
3051|136|P|to the side effects of this drug, especially increased blood||
3051|137|P|pressure and heart problems.||
3051|138|P|   During pregnancy, this medication should be used only when||
3051|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
3051|140|P|   This medication passes into breast milk. Consult your doctor||
3051|141|P|before breastfeeding.||
3051|142|B|||
3051|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3051|144|I|medications work or increase your risk for serious side effects.||
3051|145|I|This document does not contain all possible drug interactions.||
3051|146|I|Keep a list of all the products you use (including||
3051|147|I|prescription/nonprescription drugs and herbal products) and share||
3051|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
3051|149|I|the dosage of any medicines without your doctor's approval.||
3051|150|I|   Taking MAO inhibitors with this medication may cause a serious||
3051|151|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
3051|152|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
3051|153|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
3051|154|I|selegiline, tranylcypromine) during treatment with this||
3051|155|I|medication. Most MAO inhibitors should also not be taken for two||
3051|156|I|weeks before treatment with this medication. Ask your doctor when||
3051|157|I|to start or stop taking this medication.||
3051|158|I|   The risk of serotonin syndrome/toxicity increases if you are||
3051|159|I|also taking other drugs that increase serotonin. Examples include||
3051|160|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
3051|161|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
3051|162|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
3051|163|I|serotonin syndrome/toxicity may be more likely when you start or||
3051|164|I|increase the dose of these drugs.||
3051|165|I|   If you also take any ergotamine medication (such as||
3051|166|I|dihydroergotamine) or other "triptan" drugs (such as sumatriptan,||
3051|167|I|zolmitriptan), you will need to separate your rizatriptan dose at||
3051|168|I|least 24 hours apart from your dose of these other medications to||
3051|169|I|lessen the chance of serious side effects.||
3051|170|B|||
3051|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3051|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3051|173|O|poison control center right away. US residents can call||
3051|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3051|175|B|||
3051|176|N|NOTES:  Do not share this medication with others.||
3051|177|N|   Certain foods, beverages, or food additives (such as red wine,||
3051|178|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
3051|179|N|patterns such as irregular eating/sleeping habits or stress may||
3051|180|N|bring on a migraine headache. Avoiding these "triggers" may help||
3051|181|N|lessen migraine attacks. Consult your doctor for more details.||
3051|182|N|   Lab and/or medical tests (such as blood pressure) may be done||
3051|183|N|while you are taking this medication. Keep all medical and lab||
3051|184|N|appointments. Consult your doctor for more details.||
3051|185|B|||
3051|186|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
3051|187|B|||
3051|188|R|STORAGE:  Store at room temperature away from light and moisture.||
3051|189|R|Do not store in the bathroom. Keep all medications away from||
3051|190|R|children and pets.||
3051|191|R|   Do not flush medications down the toilet or pour them into a||
3051|192|R|drain unless instructed to do so. Properly discard this product||
3051|193|R|when it is expired or no longer needed. Consult your pharmacist||
3051|194|R|or local waste disposal company.||
3051|195|B|||
3051|196|A|Information last revised March 2025.||
3051|197|A|Copyright(c) 2025 First Databank, Inc.||
3051|198|B|||
3053|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3053|002|Z|does NOT have all possible information about this product. This||
3053|003|Z|information does not assure that this product is safe, effective,||
3053|004|Z|or appropriate for you. This information is not individual||
3053|005|Z|medical advice and does not substitute for the advice of your||
3053|006|Z|health care professional. Always ask your health care||
3053|007|Z|professional for complete information about this product and your||
3053|008|Z|specific health needs.||
3053|009|B|||
3053|010|T|CHLORPROMAZINE - ORAL||
3053|011|F|(klor-PRO-muh-zeen)||
3053|012|B|||
3053|013|C|COMMON BRAND NAME(S): Thorazine||
3053|014|B|||
3053|015|W|WARNING:  There may be a slightly increased risk of serious,||
3053|016|W|possibly fatal side effects (such as heart failure,||
3053|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
3053|018|W|by older adults with dementia. This medication is not approved||
3053|019|W|for the treatment of dementia-related behavior problems. Discuss||
3053|020|W|the risks and benefits of this medication, as well as other||
3053|021|W|effective and possibly safer treatments for dementia-related||
3053|022|W|behavior problems, with the doctor.||
3053|023|B|||
3053|024|U|USES:  This medication is used to treat certain mental/mood||
3053|025|U|disorders (such as schizophrenia, psychotic disorders, manic||
3053|026|U|phase of bipolar disorder, severe behavioral problems in||
3053|027|U|children). Chlorpromazine belongs to a class of drugs known as||
3053|028|U|antipsychotics. It works by helping to restore the balance of||
3053|029|U|certain natural substances in the brain.||
3053|030|U|   Chlorpromazine is also used to control nausea/vomiting,||
3053|031|U|relieve prolonged hiccups, relieve restlessness/anxiety before||
3053|032|U|surgery, and help treat tetanus.||
3053|033|B|||
3053|034|H|HOW TO USE:  Take this medication by mouth with or without food||
3053|035|H|as directed by your doctor, usually 2 to 4 times daily.||
3053|036|H|   The dosage is based on your medical condition, age, and||
3053|037|H|response to treatment. Children's dosage is also based on weight.||
3053|038|H|To reduce your risk of side effects, your doctor may direct you||
3053|039|H|to start this medication at a low dose and gradually increase||
3053|040|H|your dose. Follow your doctor's instructions carefully.||
3053|041|H|   If you are using the liquid concentrate form of this||
3053|042|H|medication, carefully measure the dose using a special measuring||
3053|043|H|device/spoon. Do not use a household spoon because you may not||
3053|044|H|get the correct dose. Mix the prescribed dose in 2 ounces (60||
3053|045|H|milliliters) or more of liquid or soft foods as directed. Some||
3053|046|H|examples of recommended liquids and soft foods to use for mixing||
3053|047|H|include: tomato or fruit juice, milk, simple syrup, coffee, tea,||
3053|048|H|soda, water, soup, or pudding.||
3053|049|H|   Take this medication regularly to get the most benefit from||
3053|050|H|it. To help you remember, take it at the same times each day.||
3053|051|H|   Although you may notice some medication effects soon after||
3053|052|H|starting, for some conditions, it may take several weeks before||
3053|053|H|you get the full benefit of this drug.||
3053|054|H|   Do not stop taking this medication without consulting your||
3053|055|H|doctor. Some conditions may become worse when this drug is||
3053|056|H|suddenly stopped. Also, you may experience symptoms such as upset||
3053|057|H|stomach, nausea, vomiting, dizziness, and shakiness. To prevent||
3053|058|H|these symptoms while you are stopping treatment with this drug,||
3053|059|H|your doctor may reduce your dose gradually. Consult your doctor||
3053|060|H|or pharmacist for more details. Report any new or worsening||
3053|061|H|symptoms right away.||
3053|062|H|   Tell your doctor if your condition does not get better or if||
3053|063|H|it gets worse.||
3053|064|B|||
3053|065|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, dry mouth,||
3053|066|S|blurred vision, tiredness, nausea, constipation, weight gain, or||
3053|067|S|trouble sleeping may occur. If any of these effects last or get||
3053|068|S|worse, tell your doctor or pharmacist promptly.||
3053|069|S|   Dizziness and lightheadedness can increase the risk of||
3053|070|S|falling. Get up slowly when rising from a sitting or lying||
3053|071|S|position.||
3053|072|S|   Tell your doctor right away if any of these side effects||
3053|073|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
3053|074|S|mask-like expression of the face, drooling/trouble swallowing, or||
3053|075|S|shuffling walk. Your doctor may prescribe another medication to||
3053|076|S|decrease these side effects.||
3053|077|S|   Remember that this medication has been prescribed because your||
3053|078|S|doctor has judged that the benefit to you is greater than the||
3053|079|S|risk of side effects. Many people using this medication do not||
3053|080|S|have serious side effects.||
3053|081|S|   Tell your doctor right away if you have any serious side||
3053|082|S|effects, including: skin discoloration, eye/vision changes, signs||
3053|083|S|of liver disease (such as nausea/vomiting that doesn't stop, loss||
3053|084|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
3053|085|S|urine), signs of infection (such as sore throat that doesn't go||
3053|086|S|away, chills), easy bruising/bleeding, mental/mood changes (such||
3053|087|S|as worsening psychosis, unresponsive/catatonic state).||
3053|088|S|   Rarely, this medication may cause face/muscle twitching and||
3053|089|S|uncontrollable movements (tardive dyskinesia). In some cases,||
3053|090|S|this condition may be permanent. Tell your doctor right away if||
3053|091|S|you develop any uncontrollable movements such as lip smacking,||
3053|092|S|mouth puckering, tongue thrusting, chewing, or unusual arm/leg||
3053|093|S|movements.||
3053|094|S|   In rare cases, chlorpromazine may increase your level of a||
3053|095|S|certain chemical made by the body (prolactin). For females, this||
3053|096|S|increase in prolactin may result in unwanted breast milk,||
3053|097|S|missed/stopped periods, or difficulty becoming pregnant. For||
3053|098|S|males, it may result in decreased sexual ability, inability to||
3053|099|S|produce sperm, or enlarged breasts. If you develop any of these||
3053|100|S|symptoms, tell your doctor right away.||
3053|101|S|   Rarely, males may have a painful or prolonged erection lasting||
3053|102|S|4 or more hours. If this occurs, stop using this drug and get||
3053|103|S|medical help right away, or permanent problems could occur.||
3053|104|S|   Get medical help right away if you have any very serious side||
3053|105|S|effects, including: severe dizziness, fainting, slow/shallow||
3053|106|S|breathing.||
3053|107|S|   This medication may rarely cause a very serious condition||
3053|108|S|called neuroleptic malignant syndrome (NMS). Get medical help||
3053|109|S|right away if you have any of the following symptoms: fever,||
3053|110|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
3053|111|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
3053|112|S|signs of kidney problems (such as change in the amount of urine).||
3053|113|S|   A very serious allergic reaction to this drug is rare.||
3053|114|S|However, get medical help right away if you notice any symptoms||
3053|115|S|of a serious allergic reaction, including: rash, itching/swelling||
3053|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3053|117|S|breathing.||
3053|118|S|   This is not a complete list of possible side effects. If you||
3053|119|S|notice other effects not listed above, contact your doctor or||
3053|120|S|pharmacist.||
3053|121|S|   In the US -||
3053|122|S|   Call your doctor for medical advice about side effects. You||
3053|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3053|124|S|www.fda.gov/medwatch.||
3053|125|S|   In Canada - Call your doctor for medical advice about side||
3053|126|S|effects. You may report side effects to Health Canada at||
3053|127|S|1-866-234-2345.||
3053|128|B|||
3053|129|P|PRECAUTIONS:  See also Warning section.||
3053|130|P|   Before taking chlorpromazine, tell your doctor or pharmacist||
3053|131|P|if you are allergic to it; or to other phenothiazine drugs (such||
3053|132|P|as perphenazine, thioridazine); or if you have any other||
3053|133|P|allergies. This product may contain inactive ingredients, which||
3053|134|P|can cause allergic reactions or other problems. Talk to your||
3053|135|P|pharmacist for more details.||
3053|136|P|   Before using this medication, tell your doctor or pharmacist||
3053|137|P|your medical history, especially of: liver problems, kidney||
3053|138|P|problems, heart problems (such as angina, heart attack,||
3053|139|P|fast/irregular heartbeat), low blood pressure, glaucoma,||
3053|140|P|seizures, enlarged prostate, breathing problems (such as severe||
3053|141|P|asthma, emphysema, lung infections), blood or blood clotting||
3053|142|P|problems (such as low white blood cell count, low platelets,||
3053|143|P|anemia, hemophilia), a certain adrenal gland tumor||
3053|144|P|(pheochromocytoma), drug/alcohol/substance use disorder,||
3053|145|P|Parkinson's disease.||
3053|146|P|   Chlorpromazine may cause a condition that affects the heart||
3053|147|P|rhythm (QT prolongation). QT prolongation can rarely cause||
3053|148|P|serious (rarely fatal) fast/irregular heartbeat and other||
3053|149|P|symptoms (such as severe dizziness, fainting) that need medical||
3053|150|P|attention right away.||
3053|151|P|   The risk of QT prolongation may be increased if you have||
3053|152|P|certain medical conditions or are taking other drugs that may||
3053|153|P|cause QT prolongation. Before using chlorpromazine, tell your||
3053|154|P|doctor or pharmacist of all the drugs you take and if you have||
3053|155|P|any of the following conditions: certain heart problems (heart||
3053|156|P|failure, slow heartbeat, QT prolongation in the EKG), family||
3053|157|P|history of certain heart problems (QT prolongation in the EKG,||
3053|158|P|sudden cardiac death).||
3053|159|P|   Low levels of potassium or magnesium in the blood may also||
3053|160|P|increase your risk of QT prolongation. This risk may increase if||
3053|161|P|you use certain drugs (such as diuretics/"water pills") or if you||
3053|162|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3053|163|P|Talk to your doctor about using chlorpromazine safely.||
3053|164|P|   This drug may make you dizzy or drowsy or cause blurred||
3053|165|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
3053|166|P|or drowsy. Do not drive, use machinery, or do anything that needs||
3053|167|P|alertness or clear vision until you can do it safely. Avoid||
3053|168|P|alcoholic beverages. Talk to your doctor if you are using||
3053|169|P|marijuana (cannabis).||
3053|170|P|   Before having surgery or imaging procedures (such as certain||
3053|171|P|X-rays, CT scans) requiring the use of contrast dye (such as||
3053|172|P|metrizamide), tell your doctor or dentist that you are using this||
3053|173|P|medication and about all the products you use (including||
3053|174|P|prescription drugs, nonprescription drugs, and herbal products).||
3053|175|P|   This medication may make you more sensitive to the sun. Limit||
3053|176|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
3053|177|P|sunscreen and wear protective clothing when outdoors. Tell your||
3053|178|P|doctor right away if you get sunburned or have skin||
3053|179|P|blisters/redness.||
3053|180|P|   This medication may make you sweat less, making you more||
3053|181|P|likely to get heat stroke. Avoid doing things that may cause you||
3053|182|P|to overheat, such as hard work or exercise in hot weather, or||
3053|183|P|using hot tubs. When the weather is hot, drink a lot of fluids||
3053|184|P|and dress lightly. If you overheat, quickly look for a place to||
3053|185|P|cool down and rest. Get medical help right away if you have a||
3053|186|P|fever that does not go away, mental/mood changes, headache, or||
3053|187|P|dizziness.||
3053|188|P|   Children may be more sensitive to the side effects of this||
3053|189|P|drug, especially uncontrolled movements. They may be at greater||
3053|190|P|risk when they are sick (such as having viral infection,||
3053|191|P|dehydration).||
3053|192|P|   Older adults may be more sensitive to the side effects of this||
3053|193|P|drug, especially dizziness, lightheadedness, drowsiness,||
3053|194|P|uncontrollable movements, constipation, difficulty urinating,||
3053|195|P|blurred vision, and QT prolongation (see above). Drowsiness,||
3053|196|P|dizziness, and lightheadedness can increase the risk of falling.||
3053|197|P|   During pregnancy, this medication should be used only when||
3053|198|P|clearly needed. Avoid use of chlorpromazine near the due date||
3053|199|P|because it may cause low blood pressure in the mother. Also,||
3053|200|P|babies born to mothers who have used this drug during the last 3||
3053|201|P|months of pregnancy may rarely develop symptoms such as muscle||
3053|202|P|stiffness or shakiness, drowsiness, feeding/breathing||
3053|203|P|difficulties, or constant crying. If you notice any of these||
3053|204|P|symptoms in your newborn, especially during their first month,||
3053|205|P|tell the doctor right away.||
3053|206|P|   Since untreated mental/mood problems (such as schizophrenia,||
3053|207|P|psychotic disorders, bipolar disorder) can be a serious||
3053|208|P|condition, do not stop using this medication unless directed by||
3053|209|P|your doctor. If you are planning pregnancy, become pregnant, or||
3053|210|P|think you may be pregnant, discuss with your doctor right away||
3053|211|P|the benefits and risks of using this medication during pregnancy.||
3053|212|P|   This medication passes into breast milk and may have||
3053|213|P|undesirable effects on a nursing infant. Consult your doctor||
3053|214|P|before breastfeeding.||
3053|215|B|||
3053|216|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3053|217|I|medications work or increase your risk for serious side effects.||
3053|218|I|This document does not contain all possible drug interactions.||
3053|219|I|Keep a list of all the products you use (including||
3053|220|I|prescription/nonprescription drugs and herbal products) and share||
3053|221|I|it with your doctor and pharmacist. Do not start, stop, or change||
3053|222|I|the dosage of any medicines without your doctor's approval.||
3053|223|I|   Some products that may interact with this drug are: lithium,||
3053|224|I|tretinoin.||
3053|225|I|   Many drugs besides chlorpromazine may affect the heart rhythm||
3053|226|I|(QT prolongation), such as amiodarone, dofetilide, pimozide,||
3053|227|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
3053|228|I|erythromycin), among others.||
3053|229|I|   The risk of serious side effects (such as slow/shallow||
3053|230|I|breathing, severe drowsiness/dizziness) may be increased if this||
3053|231|I|medication is used with other products that may also cause||
3053|232|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
3053|233|I|if you are taking other products such as opioid pain or cough||
3053|234|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3053|235|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3053|236|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3053|237|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
3053|238|I|diphenhydramine).||
3053|239|I|   Check the labels on all your medicines (such as allergy or||
3053|240|I|cough-and-cold products) because they may contain ingredients||
3053|241|I|that cause drowsiness. Ask your pharmacist about using those||
3053|242|I|products safely.||
3053|243|I|   This medication may interfere with certain lab tests (such as||
3053|244|I|certain pregnancy tests, phenylketonuria tests), possibly causing||
3053|245|I|false test results. Make sure lab personnel and all your doctors||
3053|246|I|know you use this drug.||
3053|247|B|||
3053|248|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3053|249|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3053|250|O|poison control center right away. US residents can call||
3053|251|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3053|252|O|Symptoms of overdose may include: severe drowsiness/deep sleep,||
3053|253|O|loss of consciousness, agitation, restlessness, seizures,||
3053|254|O|irregular heartbeat.||
3053|255|B|||
3053|256|N|NOTES:  Do not share this medication with others.||
3053|257|N|   Lab and/or medical tests (such as liver function, complete||
3053|258|N|blood counts, eye exams) should be done while you are using this||
3053|259|N|medication. Keep all medical and lab appointments. Consult your||
3053|260|N|doctor for more details.||
3053|261|B|||
3053|262|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3053|263|D|remember. If it is near the time of the next dose, skip the||
3053|264|D|missed dose. Take your next dose at the regular time. Do not||
3053|265|D|double the dose to catch up.||
3053|266|B|||
3053|267|R|STORAGE:  Store at room temperature away from light and moisture.||
3053|268|R|Do not store in the bathroom. Keep all medications away from||
3053|269|R|children and pets.||
3053|270|R|   Do not flush medications down the toilet or pour them into a||
3053|271|R|drain unless instructed to do so. Properly discard this product||
3053|272|R|when it is expired or no longer needed. Consult your pharmacist||
3053|273|R|or local waste disposal company.||
3053|274|B|||
3053|275|A|Information last revised May 2025.||
3053|276|A|Copyright(c) 2025 First Databank, Inc.||
3053|277|B|||
3060|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3060|002|Z|does NOT have all possible information about this product. This||
3060|003|Z|information does not assure that this product is safe, effective,||
3060|004|Z|or appropriate for you. This information is not individual||
3060|005|Z|medical advice and does not substitute for the advice of your||
3060|006|Z|health care professional. Always ask your health care||
3060|007|Z|professional for complete information about this product and your||
3060|008|Z|specific health needs.||
3060|009|B|||
3060|010|T|ALFUZOSIN EXTENDED-RELEASE - ORAL||
3060|011|F|(al-FUE-zoe-sin)||
3060|012|B|||
3060|013|C|COMMON BRAND NAME(S): Uroxatral||
3060|014|B|||
3060|015|U|USES:  Alfuzosin is used by men to treat the symptoms of an||
3060|016|U|enlarged prostate (benign prostatic hyperplasia-BPH). It does not||
3060|017|U|shrink the prostate, but it works by relaxing the muscles in the||
3060|018|U|prostate and the bladder. This helps to relieve symptoms of BPH||
3060|019|U|such as difficulty in beginning the flow of urine, weak stream,||
3060|020|U|and the need to urinate often or urgently (including during the||
3060|021|U|middle of the night).||
3060|022|U|   Alfuzosin belongs to a class of drugs known as alpha blockers.||
3060|023|U|   Do not use this medication to treat high blood pressure.||
3060|024|B|||
3060|025|V|OTHER USES:  This section contains uses of this drug that are not||
3060|026|V|listed in the approved professional labeling for the drug but||
3060|027|V|that may be prescribed by your health care professional. Use this||
3060|028|V|drug for a condition that is listed in this section only if it||
3060|029|V|has been so prescribed by your health care professional.||
3060|030|V|   Alfuzosin may also be used to help your body "pass," or get||
3060|031|V|rid of, kidney stones through urination.||
3060|032|B|||
3060|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3060|034|H|from your pharmacist before you start taking alfuzosin and each||
3060|035|H|time you get a refill. If you have any questions, ask your doctor||
3060|036|H|or pharmacist.||
3060|037|H|   Take this medication by mouth as directed by your doctor,||
3060|038|H|usually once daily after a meal. This medication works best when||
3060|039|H|taken with food. Taking alfuzosin on an empty stomach may make it||
3060|040|H|not work as well.||
3060|041|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
3060|042|H|Doing so can release all of the drug at once, increasing the risk||
3060|043|H|of side effects.||
3060|044|H|   Alfuzosin may cause a sudden drop in your blood pressure,||
3060|045|H|which could lead to dizziness or fainting, usually within a few||
3060|046|H|hours after you take it. This risk is higher when you first start||
3060|047|H|taking this drug or if you restart treatment after you stop||
3060|048|H|taking it. During these times, avoid situations where you may be||
3060|049|H|injured if you faint.||
3060|050|H|   To avoid injury from dizziness or fainting, your doctor may||
3060|051|H|tell you to take your first dose of alfuzosin with food at||
3060|052|H|bedtime so that your body can get used to its effects.||
3060|053|H|   Take this medication regularly to get the most benefit from||
3060|054|H|it. To help you remember, take it after the same meal each day.||
3060|055|H|   Tell your doctor if your condition does not get better or if||
3060|056|H|it gets worse.||
3060|057|B|||
3060|058|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur. If either||
3060|059|S|of these effects lasts or gets worse, tell your doctor or||
3060|060|S|pharmacist promptly.||
3060|061|S|   To reduce the risk of dizziness and lightheadedness, get up||
3060|062|S|slowly when rising from a sitting or lying position.||
3060|063|S|   Remember that this medication has been prescribed because your||
3060|064|S|doctor has judged that the benefit to you is greater than the||
3060|065|S|risk of side effects. Many people using this medication do not||
3060|066|S|have serious side effects.||
3060|067|S|   Get medical help right away if you have any very serious side||
3060|068|S|effects, including: severe dizziness, fainting, fast/irregular||
3060|069|S|heartbeat, chest pain.||
3060|070|S|   Rarely, males may have a painful or prolonged erection lasting||
3060|071|S|4 or more hours. If this occurs, stop using this drug and get||
3060|072|S|medical help right away, or permanent problems could occur.||
3060|073|S|   A very serious allergic reaction to this drug is rare.||
3060|074|S|However, get medical help right away if you notice any symptoms||
3060|075|S|of a serious allergic reaction, including: rash, itching/swelling||
3060|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3060|077|S|breathing.||
3060|078|S|   This is not a complete list of possible side effects. If you||
3060|079|S|notice other effects not listed above, contact your doctor or||
3060|080|S|pharmacist.||
3060|081|S|   In the US -||
3060|082|S|   Call your doctor for medical advice about side effects. You||
3060|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3060|084|S|www.fda.gov/medwatch.||
3060|085|S|   In Canada - Call your doctor for medical advice about side||
3060|086|S|effects. You may report side effects to Health Canada at||
3060|087|S|1-866-234-2345.||
3060|088|B|||
3060|089|P|PRECAUTIONS:  Before taking alfuzosin, tell your doctor or||
3060|090|P|pharmacist if you are allergic to it; or if you have any other||
3060|091|P|allergies. This product may contain inactive ingredients, which||
3060|092|P|can cause allergic reactions or other problems. Talk to your||
3060|093|P|pharmacist for more details.||
3060|094|P|   Before using this medication, tell your doctor or pharmacist||
3060|095|P|your medical history, especially of: liver disease, kidney||
3060|096|P|disease, heart problems (such as chest pain/angina, heart||
3060|097|P|attack), low blood pressure, certain eye problems (cataracts,||
3060|098|P|glaucoma).||
3060|099|P|   Alfuzosin may cause a condition that affects the heart rhythm||
3060|100|P|(QT prolongation). QT prolongation can rarely cause serious||
3060|101|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
3060|102|P|as severe dizziness, fainting) that need medical attention right||
3060|103|P|away.||
3060|104|P|   The risk of QT prolongation may be increased if you have||
3060|105|P|certain medical conditions or are taking other drugs that may||
3060|106|P|cause QT prolongation. Before using alfuzosin, tell your doctor||
3060|107|P|or pharmacist of all the drugs you take and if you have any of||
3060|108|P|the following conditions: certain heart problems (heart failure,||
3060|109|P|slow heartbeat, QT prolongation in the EKG), family history of||
3060|110|P|certain heart problems (QT prolongation in the EKG, sudden||
3060|111|P|cardiac death).||
3060|112|P|   Low levels of potassium or magnesium in the blood may also||
3060|113|P|increase your risk of QT prolongation. This risk may increase if||
3060|114|P|you use certain drugs (such as diuretics/"water pills") or if you||
3060|115|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3060|116|P|Talk to your doctor about using alfuzosin safely.||
3060|117|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3060|118|P|can make you more dizzy. Do not drive, use machinery, or do||
3060|119|P|anything that needs alertness until you can do it safely. Limit||
3060|120|P|alcoholic beverages. Talk to your doctor if you are using||
3060|121|P|marijuana (cannabis).||
3060|122|P|   Before having surgery (including cataract/glaucoma eye||
3060|123|P|surgery), tell your doctor or dentist if you are taking or have||
3060|124|P|ever taken this medication, and about all the other products you||
3060|125|P|use (including prescription drugs, nonprescription drugs, and||
3060|126|P|herbal products).||
3060|127|P|   Older adults may be more sensitive to the side effects of this||
3060|128|P|drug, especially dizziness and low blood pressure when getting up||
3060|129|P|from a sitting or lying position, and QT prolongation (see||
3060|130|P|above). These side effects can also increase the risk of falling.||
3060|131|P|   During pregnancy, this medication should be used only when||
3060|132|P|clearly needed. Discuss the risks and benefits with your doctor.||
3060|133|P|   It is unknown if this medication passes into breast milk.||
3060|134|P|Consult your doctor before breastfeeding.||
3060|135|B|||
3060|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3060|137|I|medications work or increase your risk for serious side effects.||
3060|138|I|This document does not contain all possible drug interactions.||
3060|139|I|Keep a list of all the products you use (including||
3060|140|I|prescription/nonprescription drugs and herbal products) and share||
3060|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
3060|142|I|the dosage of any medicines without your doctor's approval.||
3060|143|I|   Some products that may interact with this drug include: other||
3060|144|I|alpha blocker drugs (such as prazosin, terazosin).||
3060|145|I|   If you are also taking a drug to treat erectile dysfunction-ED||
3060|146|I|or pulmonary hypertension (such as sildenafil, tadalafil), your||
3060|147|I|blood pressure may get too low which can lead to dizziness or||
3060|148|I|fainting. Your doctor may need to adjust your medications to||
3060|149|I|minimize this risk.||
3060|150|I|   Other medications can affect the removal of alfuzosin from||
3060|151|I|your body, which may affect how alfuzosin works. Examples include||
3060|152|I|azole antifungals (such as itraconazole, ketoconazole),||
3060|153|I|clarithromycin, cobicistat, HIV protease inhibitors (such as||
3060|154|I|lopinavir), mifepristone, nefazodone, ribociclib, ritonavir,||
3060|155|I|telithromycin, among others.||
3060|156|B|||
3060|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3060|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3060|159|O|poison control center right away. US residents can call||
3060|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3060|161|O|Symptoms of overdose may include: severe dizziness, fainting.||
3060|162|B|||
3060|163|N|NOTES:  Do not share this medication with others.||
3060|164|N|   Lab and/or medical tests (such as prostate exams, blood||
3060|165|N|pressure) should be done while you are taking this medication.||
3060|166|N|Keep all medical and lab appointments. Consult your doctor for||
3060|167|N|more details.||
3060|168|B|||
3060|169|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3060|170|D|remember. If it is near the time of the next dose, skip the||
3060|171|D|missed dose. Take your next dose at the regular time. Do not||
3060|172|D|double the dose to catch up.||
3060|173|B|||
3060|174|R|STORAGE:  Store at room temperature away from light and moisture.||
3060|175|R|Do not store in the bathroom. Keep all medications away from||
3060|176|R|children and pets.||
3060|177|R|   Do not flush medications down the toilet or pour them into a||
3060|178|R|drain unless instructed to do so. Properly discard this product||
3060|179|R|when it is expired or no longer needed. Consult your pharmacist||
3060|180|R|or local waste disposal company.||
3060|181|B|||
3060|182|A|Information last revised October 2024.||
3060|183|A|Copyright(c) 2025 First Databank, Inc.||
3060|184|B|||
3063|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3063|002|Z|does NOT have all possible information about this product. This||
3063|003|Z|information does not assure that this product is safe, effective,||
3063|004|Z|or appropriate for you. This information is not individual||
3063|005|Z|medical advice and does not substitute for the advice of your||
3063|006|Z|health care professional. Always ask your health care||
3063|007|Z|professional for complete information about this product and your||
3063|008|Z|specific health needs.||
3063|009|B|||
3063|010|T|MALATHION - TOPICAL||
3063|011|F|(mal-uh-THIGH-on)||
3063|012|B|||
3063|013|C|COMMON BRAND NAME(S): Ovide||
3063|014|B|||
3063|015|U|USES:  This medication is used to treat head lice, tiny insects||
3063|016|U|that infest and irritate your scalp. Malathion belongs to a class||
3063|017|U|of drugs known as organophosphates. It works by paralyzing and||
3063|018|U|killing lice and their eggs (nits).||
3063|019|U|   This drug is not recommended for use in newborns or infants||
3063|020|U|younger than 1 year.||
3063|021|B|||
3063|022|H|HOW TO USE:  Learn all preparation and usage instructions in the||
3063|023|H|product package. If you have any questions, ask your doctor or||
3063|024|H|pharmacist.||
3063|025|H|   This medication is for use on hair and scalp only. Do not||
3063|026|H|swallow. Be careful to avoid getting malathion in your nose,||
3063|027|H|ears, mouth, vagina, or eyes. Protect eyes during application by||
3063|028|H|keeping them tightly closed and covered with a cloth or towel. If||
3063|029|H|the medication accidentally comes in contact with your eyes,||
3063|030|H|flush them with water to reduce irritation. If irritation||
3063|031|H|continues or you experience vision changes, talk to your doctor.||
3063|032|H|   Apply this medication onto dry hair and scalp. Use enough||
3063|033|H|medication to make the hair and scalp wet, especially the back of||
3063|034|H|the head and neck. Allow the hair to air-dry, uncovered. Wash||
3063|035|H|hands after applying this medication. Leave malathion on the hair||
3063|036|H|and scalp for 8-12 hours. Then shampoo and rinse well, especially||
3063|037|H|the back of the head and neck.||
3063|038|H|   Run a fine-toothed comb (nit comb) through your wet hair to||
3063|039|H|remove the dead lice and lice eggs. The infected person should be||
3063|040|H|checked by another person for lice and nits. Please see the||
3063|041|H|instructions in the product package for more details about nit||
3063|042|H|removal. Consult your doctor if lice are still present after 7-9||
3063|043|H|days. Repeat treatment with this or other medication may be||
3063|044|H|necessary.||
3063|045|H|   This medication may cause a slight stinging feeling on the||
3063|046|H|scalp. This is normal. However, if skin irritation occurs, wash||
3063|047|H|the scalp and hair right away, allow the irritation to clear, and||
3063|048|H|try using the medication again. If the irritation returns,||
3063|049|H|consult your doctor.||
3063|050|H|   This medication is flammable until dry. Avoid smoking, being||
3063|051|H|near open flames, or using electric heat sources (such as||
3063|052|H|heaters, hair dryers, curlers/hair irons) while using the||
3063|053|H|medication and until the medication has dried.||
3063|054|B|||
3063|055|S|SIDE EFFECTS:  Burning, stinging, dry hair, or a temporary||
3063|056|S|increase in dandruff may occur. If any of these effects last or||
3063|057|S|get worse, tell your doctor or pharmacist promptly.||
3063|058|S|   Remember that this medication has been prescribed because your||
3063|059|S|doctor has judged that the benefit to you is greater than the||
3063|060|S|risk of side effects. Many people using this medication do not||
3063|061|S|have serious side effects.||
3063|062|S|   A very serious allergic reaction to this drug is rare.||
3063|063|S|However, get medical help right away if you notice any symptoms||
3063|064|S|of a serious allergic reaction, including: rash, itching/swelling||
3063|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3063|066|S|breathing.||
3063|067|S|   This is not a complete list of possible side effects. If you||
3063|068|S|notice other effects not listed above, contact your doctor or||
3063|069|S|pharmacist.||
3063|070|S|   In the US -||
3063|071|S|   Call your doctor for medical advice about side effects. You||
3063|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3063|073|S|www.fda.gov/medwatch.||
3063|074|S|   In Canada - Call your doctor for medical advice about side||
3063|075|S|effects. You may report side effects to Health Canada at||
3063|076|S|1-866-234-2345.||
3063|077|B|||
3063|078|P|PRECAUTIONS:  Before using malathion, tell your doctor or||
3063|079|P|pharmacist if you are allergic to it; or if you have any other||
3063|080|P|allergies. This product may contain inactive ingredients, which||
3063|081|P|can cause allergic reactions or other problems. Talk to your||
3063|082|P|pharmacist for more details.||
3063|083|P|   Before using this medication, tell your doctor or pharmacist||
3063|084|P|your medical history, especially of: asthma, skin infections,||
3063|085|P|skin or scalp problems (such as psoriasis, eczema), open||
3063|086|P|sores/wounds on the scalp (such as minor cuts, scrapes).||
3063|087|P|   Constant or forceful scratching of the scalp may lead to a||
3063|088|P|bacterial skin infection. Tell your doctor right away if you||
3063|089|P|develop worsening redness or pus.||
3063|090|P|   During pregnancy, this medication should be used only when||
3063|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
3063|092|P|If you are pregnant and applying this medication on another||
3063|093|P|person, handle it with care.||
3063|094|P|   It is unknown if this drug passes into breast milk. Consult||
3063|095|P|your doctor before breastfeeding.||
3063|096|B|||
3063|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3063|098|I|medications work or increase your risk for serious side effects.||
3063|099|I|This document does not contain all possible drug interactions.||
3063|100|I|Keep a list of all the products you use (including||
3063|101|I|prescription/nonprescription drugs and herbal products) and share||
3063|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
3063|103|I|the dosage of any medicines without your doctor's approval.||
3063|104|B|||
3063|105|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3063|106|O|has overdosed and has serious symptoms such as passing out or||
3063|107|O|trouble breathing, call 911. Otherwise, call a poison control||
3063|108|O|center right away. US residents can call 1-800-222-1222. Canada||
3063|109|O|residents can call 1-844-764-7669. Symptoms of overdose may||
3063|110|O|include: breathing problems, muscle weakness/paralysis, shaking,||
3063|111|O|increased sweating/saliva/tears, increased urine, nausea,||
3063|112|O|vomiting, diarrhea, anxiety, headache, confusion, dizziness,||
3063|113|O|drowsiness, slow or fast heartbeat.||
3063|114|B|||
3063|115|N|NOTES:  Do not share this medication unless directed to do so by||
3063|116|N|your doctor.||
3063|117|N|   One application is usually all that is needed. To avoid giving||
3063|118|N|lice to another person or getting them again, all headwear,||
3063|119|N|scarves, coats, and bed linens should be machine-washed with hot||
3063|120|N|water and dried in a dryer (at high setting) for at least 20||
3063|121|N|minutes, dry cleaned, sealed in a plastic bag for 2 weeks, or||
3063|122|N|sprayed with a disinfectant that kills lice. Brushes and combs||
3063|123|N|should be soaked in hot water (hotter than 130 degrees F/54||
3063|124|N|degrees C) for 10 minutes, soaked in alcohol for 1 hour, or||
3063|125|N|thrown away. Furniture and floors should be thoroughly vacuumed.||
3063|126|N|   People who are in close contact with the infected person, such||
3063|127|N|as members of the same household, should also be checked for lice||
3063|128|N|and nits. Treatment may be considered to prevent infestation even||
3063|129|N|if live lice are not found on them.||
3063|130|B|||
3063|131|D|MISSED DOSE:  Not applicable.||
3063|132|B|||
3063|133|R|STORAGE:  Store at room temperature away from open flame. Keep||
3063|134|R|all medications away from children and pets.||
3063|135|R|   Do not flush medications down the toilet or pour them into a||
3063|136|R|drain unless instructed to do so. Properly discard this product||
3063|137|R|when it is expired or no longer needed. Consult your pharmacist||
3063|138|R|or local waste disposal company.||
3063|139|B|||
3063|140|A|Information last revised July 2025.||
3063|141|A|Copyright(c) 2025 First Databank, Inc.||
3063|142|B|||
3069|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3069|002|Z|does NOT have all possible information about this product. This||
3069|003|Z|information does not assure that this product is safe, effective,||
3069|004|Z|or appropriate for you. This information is not individual||
3069|005|Z|medical advice and does not substitute for the advice of your||
3069|006|Z|health care professional. Always ask your health care||
3069|007|Z|professional for complete information about this product and your||
3069|008|Z|specific health needs.||
3069|009|B|||
3069|010|T|VALACYCLOVIR - ORAL||
3069|011|F|(val-uh-SYE-klo-veer)||
3069|012|B|||
3069|013|C|COMMON BRAND NAME(S): Valtrex||
3069|014|B|||
3069|015|U|USES:  Valacyclovir is used to treat infections caused by certain||
3069|016|U|types of viruses. In children, it is used to treat cold sores||
3069|017|U|around the mouth (caused by herpes simplex) and chickenpox||
3069|018|U|(caused by varicella zoster). In adults, it is used to treat||
3069|019|U|shingles (caused by herpes zoster) and cold sores around the||
3069|020|U|mouth.||
3069|021|U|   Valacyclovir is also used to treat outbreaks of genital||
3069|022|U|herpes. In people with frequent outbreaks, this medication is||
3069|023|U|used to reduce the number of future episodes.||
3069|024|U|   Valacyclovir is an antiviral drug. It stops the growth of||
3069|025|U|certain viruses. However, it is not a cure for these infections.||
3069|026|U|The viruses that cause these infections continue to live in the||
3069|027|U|body even between outbreaks. Valacyclovir decreases the severity||
3069|028|U|and length of these outbreaks. It helps the sores heal faster,||
3069|029|U|keeps new sores from forming, and decreases pain/itching. This||
3069|030|U|medication may also help reduce how long pain remains after the||
3069|031|U|sores heal.||
3069|032|B|||
3069|033|V|OTHER USES:  This section contains uses of this drug that are not||
3069|034|V|listed in the approved professional labeling for the drug but||
3069|035|V|that may be prescribed by your health care professional. Use this||
3069|036|V|drug for a condition that is listed in this section only if it||
3069|037|V|has been so prescribed by your health care professional.||
3069|038|V|   This drug may also be used to reduce the risk of another type||
3069|039|V|of viral infection (cytomegalovirus) in some people.||
3069|040|B|||
3069|041|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3069|042|H|from your pharmacist before you start taking valacyclovir and||
3069|043|H|each time you get a refill. If you have any questions, ask your||
3069|044|H|doctor or pharmacist.||
3069|045|H|   Take valacyclovir by mouth with or without food as directed by||
3069|046|H|your doctor. Drink plenty of fluids while taking this medication||
3069|047|H|to lower the chance of side effects.||
3069|048|H|   The dosage and length of treatment are based on your medical||
3069|049|H|condition and response to treatment. Children's dosage may also||
3069|050|H|be based on weight.||
3069|051|H|   This medication works best when started at the first sign of||
3069|052|H|an outbreak, as directed by your doctor. It may not work as well||
3069|053|H|if you delay treatment. For shingles or chickenpox, start taking||
3069|054|H|valacyclovir at the first symptom or as soon as possible after||
3069|055|H|the rash appears. For cold sores or genital herpes, start taking||
3069|056|H|this medication at the first sign or as soon as you feel||
3069|057|H|tingling, itching, or burning.||
3069|058|H|   Valacyclovir works best when the amount of medicine in your||
3069|059|H|body is kept at a constant level. Take this drug at evenly spaced||
3069|060|H|intervals. To help you remember, take it at the same time(s) each||
3069|061|H|day.||
3069|062|H|   Continue to take this medication until the full prescribed||
3069|063|H|amount is finished. Do not change your dose, skip any doses, or||
3069|064|H|stop this medication early without your doctor's approval.||
3069|065|H|   Tell your doctor if your condition lasts or gets worse.||
3069|066|B|||
3069|067|S|SIDE EFFECTS:  Nausea, stomach pain, headache, or dizziness may||
3069|068|S|occur. If any of these effects last or get worse, tell your||
3069|069|S|doctor or pharmacist promptly.||
3069|070|S|   Remember that this medication has been prescribed because your||
3069|071|S|doctor has judged that the benefit to you is greater than the||
3069|072|S|risk of side effects. Many people using this medication do not||
3069|073|S|have serious side effects.||
3069|074|S|   Tell your doctor right away if you have any serious side||
3069|075|S|effects, including: signs of kidney problems (such as a change in||
3069|076|S|the amount of urine, unusual back/side pain), mental/mood changes||
3069|077|S|(such as agitation, confusion, hallucinations), shaky/unsteady||
3069|078|S|movement, unusual tiredness, fast heartbeat, easy||
3069|079|S|bruising/bleeding, new fever, bloody/dark urine, severe||
3069|080|S|stomach/abdominal pain, yellowing eyes/skin.||
3069|081|S|   Get medical help right away if you have any very serious side||
3069|082|S|effects, including: sudden vision changes, trouble speaking, loss||
3069|083|S|of consciousness, seizures.||
3069|084|S|   A very serious allergic reaction to this drug is rare.||
3069|085|S|However, get medical help right away if you notice any symptoms||
3069|086|S|of a serious allergic reaction, including: fever that doesn't go||
3069|087|S|away, new or worsening lymph node swelling, rash,||
3069|088|S|itching/swelling (especially of the face/tongue/throat), severe||
3069|089|S|dizziness, trouble breathing.||
3069|090|S|   This is not a complete list of possible side effects. If you||
3069|091|S|notice other effects not listed above, contact your doctor or||
3069|092|S|pharmacist.||
3069|093|S|   In the US -||
3069|094|S|   Call your doctor for medical advice about side effects. You||
3069|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3069|096|S|www.fda.gov/medwatch.||
3069|097|S|   In Canada - Call your doctor for medical advice about side||
3069|098|S|effects. You may report side effects to Health Canada at||
3069|099|S|1-866-234-2345.||
3069|100|B|||
3069|101|P|PRECAUTIONS:  Before taking valacyclovir, tell your doctor or||
3069|102|P|pharmacist if you are allergic to it; or to acyclovir; or if you||
3069|103|P|have any other allergies. This product may contain inactive||
3069|104|P|ingredients, which can cause allergic reactions or other||
3069|105|P|problems. Talk to your pharmacist for more details.||
3069|106|P|   Before using this medication, tell your doctor or pharmacist||
3069|107|P|your medical history, especially of: kidney problems, immune||
3069|108|P|system problems.||
3069|109|P|   This drug may rarely make you dizzy. Alcohol or marijuana||
3069|110|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
3069|111|P|or do anything that needs alertness until you can do it safely.||
3069|112|P|Limit alcoholic beverages. Talk to your doctor if you are using||
3069|113|P|marijuana (cannabis).||
3069|114|P|   Before having surgery, tell your doctor or dentist about all||
3069|115|P|the products you use (including prescription drugs,||
3069|116|P|nonprescription drugs, and herbal products).||
3069|117|P|   Tell your health care professional that you are using||
3069|118|P|valacyclovir before having any immunizations/vaccinations (such||
3069|119|P|as vaccines against the varicella virus).||
3069|120|P|   Older adults may be more sensitive to the side effects of this||
3069|121|P|drug, especially mental/mood changes (such as confusion,||
3069|122|P|agitation) and kidney problems (such as a change in the amount of||
3069|123|P|urine).||
3069|124|P|   Cold sores can spread easily. Avoid close physical contact||
3069|125|P|with others (such as kissing) during an outbreak until the cold||
3069|126|P|sores have completely healed. Try not to touch the cold sore. If||
3069|127|P|you do, wash your hands afterward.||
3069|128|P|   Valacyclovir does not prevent the spread of herpes. To lower||
3069|129|P|the chance of giving genital herpes to your partner, do not have||
3069|130|P|sexual contact during an outbreak or if you have symptoms. You||
3069|131|P|can spread genital herpes even if you do not have symptoms.||
3069|132|P|Always use an effective barrier method (latex or polyurethane||
3069|133|P|condoms/dental dams) during all sexual activity. Consult your||
3069|134|P|doctor or pharmacist for more details.||
3069|135|P|   During pregnancy, this medication should be used only when||
3069|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
3069|137|P|   This medication passes into breast milk, but is unlikely to||
3069|138|P|harm a nursing infant. Consult your doctor before breastfeeding.||
3069|139|B|||
3069|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3069|141|I|medications work or increase your risk for serious side effects.||
3069|142|I|This document does not contain all possible drug interactions.||
3069|143|I|Keep a list of all the products you use (including||
3069|144|I|prescription/nonprescription drugs and herbal products) and share||
3069|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
3069|146|I|the dosage of any medicines without your doctor's approval.||
3069|147|I|   Some products that may interact with this drug include: other||
3069|148|I|drugs that may cause kidney problems (including nonsteroidal||
3069|149|I|anti-inflammatory drugs-NSAIDs such as ibuprofen, naproxen).||
3069|150|I|   Valacyclovir is very similar to acyclovir. Do not use||
3069|151|I|medications containing acyclovir while using valacyclovir.||
3069|152|B|||
3069|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3069|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3069|155|O|poison control center right away. US residents can call||
3069|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3069|157|O|Symptoms of overdose may include: change in the amount of urine,||
3069|158|O|extreme tiredness, mental/mood changes, loss of consciousness,||
3069|159|O|seizures.||
3069|160|B|||
3069|161|N|NOTES:  Do not share this medication with others.||
3069|162|N|   This medication has been prescribed for your current condition||
3069|163|N|only. Do not use it later for another infection unless your||
3069|164|N|doctor tells you to.||
3069|165|B|||
3069|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3069|167|D|remember. If it is near the time of the next dose, skip the||
3069|168|D|missed dose. Take your next dose at the regular time. Do not||
3069|169|D|double the dose to catch up.||
3069|170|B|||
3069|171|R|STORAGE:  Store at room temperature away from light and moisture.||
3069|172|R|Do not store in the bathroom. Keep all medications away from||
3069|173|R|children and pets.||
3069|174|R|   Do not flush medications down the toilet or pour them into a||
3069|175|R|drain unless instructed to do so. Properly discard this product||
3069|176|R|when it is expired or no longer needed. Consult your pharmacist||
3069|177|R|or local waste disposal company.||
3069|178|B|||
3069|179|A|Information last revised November 2025.||
3069|180|A|Copyright(c) 2025 First Databank, Inc.||
3069|181|B|||
3075|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3075|002|Z|does NOT have all possible information about this product. This||
3075|003|Z|information does not assure that this product is safe, effective,||
3075|004|Z|or appropriate for you. This information is not individual||
3075|005|Z|medical advice and does not substitute for the advice of your||
3075|006|Z|health care professional. Always ask your health care||
3075|007|Z|professional for complete information about this product and your||
3075|008|Z|specific health needs.||
3075|009|B|||
3075|010|T|AMLODIPINE/BENAZEPRIL - ORAL||
3075|011|F|(am-LOE-di-peen/ben-AZ-e-pril)||
3075|012|B|||
3075|013|C|COMMON BRAND NAME(S): Lotrel||
3075|014|B|||
3075|015|W|WARNING:  Benazepril (one of the ingredients in this product) can||
3075|016|W|cause serious (possibly fatal) harm to an unborn baby if used||
3075|017|W|during pregnancy. It is important to prevent pregnancy while||
3075|018|W|taking this medication. Consult your doctor for more details and||
3075|019|W|to discuss the use of reliable forms of birth control while||
3075|020|W|taking this medication. If you are planning pregnancy, become||
3075|021|W|pregnant, or think you may be pregnant, tell your doctor right||
3075|022|W|away.||
3075|023|B|||
3075|024|U|USES:  This product is a combination of two drugs: a calcium||
3075|025|U|channel blocker (amlodipine) and an ACE inhibitor (benazepril).||
3075|026|U|It is used to treat high blood pressure. It works by relaxing||
3075|027|U|blood vessels so that blood can flow more easily. Lowering high||
3075|028|U|blood pressure helps prevent strokes, heart attacks and kidney||
3075|029|U|problems.||
3075|030|B|||
3075|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3075|032|H|from your pharmacist before you start taking this medicine. If||
3075|033|H|you have any questions, ask your doctor or pharmacist.||
3075|034|H|   Take this medication by mouth with or without food as directed||
3075|035|H|by your doctor, usually once daily. The dosage is based on your||
3075|036|H|medical condition and response to treatment.||
3075|037|H|   Use this medication regularly in order to get the most benefit||
3075|038|H|from it. To help you remember, take it at the same time each day.||
3075|039|H|Keep taking this medication even if you feel well. Most people||
3075|040|H|with high blood pressure do not feel sick.||
3075|041|H|   It may take 1 to 2 weeks before you get the full benefit of||
3075|042|H|this medication. Tell your doctor if your condition does not get||
3075|043|H|better or if it gets worse (your blood pressure readings remain||
3075|044|H|high or increase).||
3075|045|B|||
3075|046|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
3075|047|S|body adjusts to the medication. Dry cough or swelling||
3075|048|S|hands/ankles/feet may also occur. If any of these effects last or||
3075|049|S|get worse, tell your doctor or pharmacist promptly.||
3075|050|S|   To reduce the risk of dizziness and lightheadedness, get up||
3075|051|S|slowly when rising from a sitting or lying position.||
3075|052|S|   Remember that this medication has been prescribed because your||
3075|053|S|doctor has judged that the benefit to you is greater than the||
3075|054|S|risk of side effects. Many people using this medication do not||
3075|055|S|have serious side effects.||
3075|056|S|   Tell your doctor right away if any of these serious side||
3075|057|S|effects occur: fainting, fast/irregular/pounding heartbeat,||
3075|058|S|symptoms of a high potassium blood level (such as muscle||
3075|059|S|weakness, slow/irregular heartbeat), signs of kidney problems||
3075|060|S|(such as change in the amount of urine).||
3075|061|S|   This product may rarely cause serious (possibly fatal) liver||
3075|062|S|problems. Get medical help right away if you have any symptoms of||
3075|063|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
3075|064|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
3075|065|S|urine.||
3075|066|S|   Some people who already have severe heart disease may rarely||
3075|067|S|develop worsening chest pain or a heart attack after starting||
3075|068|S|this medication or increasing the dose. Get medical help right||
3075|069|S|away if you experience: worsening chest pain, symptoms of a heart||
3075|070|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
3075|071|S|unusual sweating).||
3075|072|S|   A very serious allergic reaction to this drug is rare.||
3075|073|S|However, get medical help right away if you notice any symptoms||
3075|074|S|of a serious allergic reaction, including: rash, itching/swelling||
3075|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3075|076|S|breathing.||
3075|077|S|   This is not a complete list of possible side effects. If you||
3075|078|S|notice other effects not listed above, contact your doctor or||
3075|079|S|pharmacist.||
3075|080|S|   In the US -||
3075|081|S|   Call your doctor for medical advice about side effects. You||
3075|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3075|083|S|www.fda.gov/medwatch.||
3075|084|S|   In Canada - Call your doctor for medical advice about side||
3075|085|S|effects. You may report side effects to Health Canada at||
3075|086|S|1-866-234-2345.||
3075|087|B|||
3075|088|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
3075|089|P|pharmacist if you are allergic to amlodipine or benazepril; or to||
3075|090|P|other dihydropyridine calcium channel blockers (such as||
3075|091|P|nisoldipine, nifedipine); or to other ACE inhibitors (such as||
3075|092|P|captopril, lisinopril); or if you have any other allergies. This||
3075|093|P|product may contain inactive ingredients, which can cause||
3075|094|P|allergic reactions or other problems. Talk to your pharmacist for||
3075|095|P|more details.||
3075|096|P|   Before using this medication, tell your doctor or pharmacist||
3075|097|P|your medical history, especially of: history of an allergic||
3075|098|P|reaction which included swelling of the face/lips/tongue/throat||
3075|099|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
3075|100|P|dialysis), liver disease, a certain structural heart problem||
3075|101|P|(aortic stenosis).||
3075|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3075|103|P|can make you more dizzy. Do not drive, use machinery, or do||
3075|104|P|anything that needs alertness until you can do it safely. Limit||
3075|105|P|alcoholic beverages. Talk to your doctor if you are using||
3075|106|P|marijuana (cannabis).||
3075|107|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
3075|108|P|and cause you to feel lightheaded. Tell your doctor if you have||
3075|109|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
3075|110|P|of fluids unless your doctor tells you not to.||
3075|111|P|   Before having surgery, tell your doctor or dentist about all||
3075|112|P|the products you use (including prescription drugs,||
3075|113|P|nonprescription drugs, and herbal products).||
3075|114|P|   This product may increase your potassium levels. Before using||
3075|115|P|potassium supplements or salt substitutes that contain potassium,||
3075|116|P|consult your doctor or pharmacist.||
3075|117|P|   Older adults may be more sensitive to the side effects of this||
3075|118|P|drug, including dizziness, increases in potassium level, and||
3075|119|P|change in the amount of urine (kidney problems).||
3075|120|P|   Tell your doctor if you are pregnant or plan to become||
3075|121|P|pregnant. You should not become pregnant while using this||
3075|122|P|medication. Benazepril may harm an unborn baby. If you become||
3075|123|P|pregnant, talk to your doctor right away about the risks and||
3075|124|P|benefits of this medication. See also Warning section.||
3075|125|P|   This product passes into breast milk. Consult your doctor||
3075|126|P|before breastfeeding.||
3075|127|B|||
3075|128|I|DRUG INTERACTIONS:  See also Precautions section.||
3075|129|I|   Drug interactions may change how your medications work or||
3075|130|I|increase your risk for serious side effects. This document does||
3075|131|I|not contain all possible drug interactions. Keep a list of all||
3075|132|I|the products you use (including prescription/nonprescription||
3075|133|I|drugs and herbal products) and share it with your doctor and||
3075|134|I|pharmacist. Do not start, stop, or change the dosage of any||
3075|135|I|medicines without your doctor's approval.||
3075|136|I|   Some products that may interact with this drug include:||
3075|137|I|aliskiren, certain drugs that weaken the immune system/increase||
3075|138|I|the risk of infection (such as everolimus, sirolimus), lithium,||
3075|139|I|drugs that may increase the level of potassium in the blood (such||
3075|140|I|as ARBs including losartan/valsartan, birth control pills||
3075|141|I|containing drospirenone), gold injections, sacubitril.||
3075|142|I|   Some products have ingredients that could raise your blood||
3075|143|I|pressure. Tell your pharmacist what products you are using, and||
3075|144|I|ask how to use them safely (especially cough-and-cold products,||
3075|145|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
3075|146|I|   A very serious reaction may occur if you are getting||
3075|147|I|injections for bee/wasp sting allergy (desensitization) and are||
3075|148|I|also taking benazepril. Make sure all your doctors know which||
3075|149|I|medicines you are using.||
3075|150|B|||
3075|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3075|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3075|153|O|poison control center right away. US residents can call||
3075|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3075|155|O|Symptoms of overdose may include: severe dizziness, fainting, and||
3075|156|O|unusually fast or slow heartbeat.||
3075|157|B|||
3075|158|N|NOTES:  Do not share this medication with others.||
3075|159|N|   Lifestyle changes that may help this medication work better||
3075|160|N|include exercising, stopping smoking, and eating a||
3075|161|N|low-cholesterol/low-fat diet. Consult your doctor for more||
3075|162|N|details.||
3075|163|N|   Lab and/or medical tests (such as kidney function, potassium||
3075|164|N|levels) should be done while you are taking this medication. Keep||
3075|165|N|all medical and lab appointments. Consult your doctor for more||
3075|166|N|details.||
3075|167|N|   Check your blood pressure and pulse (heart rate) regularly||
3075|168|N|while taking this medication. Learn how to check your own blood||
3075|169|N|pressure and pulse at home, and share the results with your||
3075|170|N|doctor.||
3075|171|B|||
3075|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3075|173|D|remember. If it is near the time of the next dose, skip the||
3075|174|D|missed dose. Take your next dose at the regular time. Do not||
3075|175|D|double the dose to catch up.||
3075|176|B|||
3075|177|R|STORAGE:  Store at room temperature away from light and moisture.||
3075|178|R|Do not store in the bathroom. Keep all medications away from||
3075|179|R|children and pets.||
3075|180|R|   Do not flush medications down the toilet or pour them into a||
3075|181|R|drain unless instructed to do so. Properly discard this product||
3075|182|R|when it is expired or no longer needed. Consult your pharmacist||
3075|183|R|or local waste disposal company.||
3075|184|B|||
3075|185|A|Information last revised May 2024.||
3075|186|A|Copyright(c) 2025 First Databank, Inc.||
3075|187|B|||
3076|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3076|002|Z|does NOT have all possible information about this product. This||
3076|003|Z|information does not assure that this product is safe, effective,||
3076|004|Z|or appropriate for you. This information is not individual||
3076|005|Z|medical advice and does not substitute for the advice of your||
3076|006|Z|health care professional. Always ask your health care||
3076|007|Z|professional for complete information about this product and your||
3076|008|Z|specific health needs.||
3076|009|B|||
3076|010|T|THEOPHYLLINE SUSTAINED-RELEASE - ORAL||
3076|011|F|(thee-OF-i-lin)||
3076|012|B|||
3076|013|C|COMMON BRAND NAME(S): Uniphyl||
3076|014|B|||
3076|015|U|USES:  Theophylline is used to treat lung diseases such as asthma||
3076|016|U|and COPD (bronchitis, emphysema). It must be used regularly to||
3076|017|U|prevent wheezing and shortness of breath. This medication belongs||
3076|018|U|to a class of drugs known as xanthines. It works by relaxing the||
3076|019|U|muscles around the airways so that they open up and you can||
3076|020|U|breathe more easily. It also decreases the lungs' response to||
3076|021|U|irritants. Controlling symptoms of breathing problems can||
3076|022|U|decrease time lost from work or school.||
3076|023|U|   This medication must be used regularly to be effective. It||
3076|024|U|does not work right away and should not be used to relieve sudden||
3076|025|U|breathing problems. If sudden shortness of breath occurs, use||
3076|026|U|your quick-relief inhaler as prescribed.||
3076|027|B|||
3076|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
3076|029|H|doctor, usually once or twice daily. Since different||
3076|030|H|manufacturers have different ways to take this medication, ask||
3076|031|H|your doctor or pharmacist about the best time(s) to take your||
3076|032|H|brand of theophylline and if you should take the drug with or||
3076|033|H|without food.||
3076|034|H|   Do not crush or chew the capsules or tablets. Doing so can||
3076|035|H|release all of the drug at once, increasing the risk of side||
3076|036|H|effects. Also, do not split the tablets unless they have a score||
3076|037|H|line and your doctor or pharmacist tells you to do so. Swallow||
3076|038|H|the whole or split tablet without crushing or chewing.||
3076|039|H|   The dosage is based on your medical condition, response to||
3076|040|H|treatment, age, weight, lab tests (theophylline blood levels),||
3076|041|H|and other medications you may be taking. Be sure to tell your||
3076|042|H|doctor and pharmacist about all the products you use (including||
3076|043|H|prescription drugs, nonprescription drugs, and herbal products).||
3076|044|H|To reduce your risk of side effects, your doctor may direct you||
3076|045|H|to start this medication at a low dose and gradually increase||
3076|046|H|your dose. Follow your doctor's instructions carefully.||
3076|047|H|   Certain diets (such as high protein/low carbohydrate or high||
3076|048|H|carbohydrate/low protein) may change the effect of theophylline.||
3076|049|H|Tell your doctor if you have any major changes in your diet. Your||
3076|050|H|doctor may need to adjust your dose.||
3076|051|H|   Caffeine and alcohol can increase the side effects of this||
3076|052|H|medication. Avoid drinking large amounts of beverages containing||
3076|053|H|alcohol or caffeine (such as coffee, tea, colas), eating large||
3076|054|H|amounts of chocolate, or taking nonprescription products that||
3076|055|H|contain caffeine.||
3076|056|H|   Take this medication regularly to get the most benefit from||
3076|057|H|it. To help you remember, take it at the same time(s) each day.||
3076|058|H|Keep taking this medication even if you feel well. Do not||
3076|059|H|increase your dose, take this drug more often, or stop taking it||
3076|060|H|without first consulting your doctor.||
3076|061|H|   Get medical help right away if your asthma symptoms worsen or||
3076|062|H|if you are using your quick-relief inhaler more than usual or||
3076|063|H|more often than prescribed.||
3076|064|B|||
3076|065|S|SIDE EFFECTS:  Nausea/vomiting, stomach/abdominal pain, headache,||
3076|066|S|trouble sleeping, diarrhea, irritability, restlessness,||
3076|067|S|nervousness, shaking, or increased urination may occur. If any of||
3076|068|S|these effects last or get worse, tell your doctor or pharmacist||
3076|069|S|promptly.||
3076|070|S|   Remember that this medication has been prescribed because your||
3076|071|S|doctor has judged that the benefit to you is greater than the||
3076|072|S|risk of side effects. Many people using this medication do not||
3076|073|S|have serious side effects.||
3076|074|S|   Tell your doctor right away if you have any serious side||
3076|075|S|effects, including: nausea/vomiting that doesn't stop,||
3076|076|S|fast/slow/irregular heartbeat, muscle cramps, fainting,||
3076|077|S|confusion, dizziness.||
3076|078|S|   Get medical help right away if you have any very serious side||
3076|079|S|effects, including: seizures.||
3076|080|S|   A very serious allergic reaction to this drug is rare.||
3076|081|S|However, get medical help right away if you notice any symptoms||
3076|082|S|of a serious allergic reaction, including: rash, itching/swelling||
3076|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3076|084|S|breathing.||
3076|085|S|   This is not a complete list of possible side effects. If you||
3076|086|S|notice other effects not listed above, contact your doctor or||
3076|087|S|pharmacist.||
3076|088|S|   In the US -||
3076|089|S|   Call your doctor for medical advice about side effects. You||
3076|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3076|091|S|www.fda.gov/medwatch.||
3076|092|S|   In Canada - Call your doctor for medical advice about side||
3076|093|S|effects. You may report side effects to Health Canada at||
3076|094|S|1-866-234-2345.||
3076|095|B|||
3076|096|P|PRECAUTIONS:  Before using theophylline, tell your doctor or||
3076|097|P|pharmacist if you are allergic to it; or to other xanthine drugs||
3076|098|P|(such as aminophylline, oxtriphylline, caffeine); or if you have||
3076|099|P|any other allergies. This product may contain inactive||
3076|100|P|ingredients, which can cause allergic reactions or other||
3076|101|P|problems. Talk to your pharmacist for more details.||
3076|102|P|   Before using this medication, tell your doctor or pharmacist||
3076|103|P|your medical history, especially of: stomach/intestinal ulcer,||
3076|104|P|seizures, thyroid disease, heart problems (such as heart failure,||
3076|105|P|irregular heartbeat), liver disease, high blood pressure.||
3076|106|P|   If you get sick or have a fever while taking this medication,||
3076|107|P|tell your doctor right away. The dose of your medicine may need||
3076|108|P|to be adjusted.||
3076|109|P|   Before having surgery, tell your doctor or dentist about all||
3076|110|P|the products you use (including prescription drugs,||
3076|111|P|nonprescription drugs, and herbal products).||
3076|112|P|   Older adults may be more sensitive to the side effects of this||
3076|113|P|drug, especially fast/irregular heartbeat, or trouble sleeping.||
3076|114|P|Careful monitoring of side effects and drug blood levels is||
3076|115|P|recommended.||
3076|116|P|   Children may be more sensitive to the side effects of this||
3076|117|P|drug. Careful monitoring of side effects and drug blood levels is||
3076|118|P|recommended.||
3076|119|P|   During pregnancy, this medication should be used only when||
3076|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
3076|121|P|Changes in your body during the last 3 months of pregnancy may||
3076|122|P|affect the amount of this drug in your blood. Your doctor should||
3076|123|P|carefully monitor the amount of drug in your blood, as well as||
3076|124|P|any side effects, so that your dose may be changed if needed.||
3076|125|P|   This drug passes into breast milk and may have undesirable||
3076|126|P|effects on a nursing infant. Consult your doctor before||
3076|127|P|breastfeeding.||
3076|128|B|||
3076|129|I|DRUG INTERACTIONS:  See also How to Use section.||
3076|130|I|   Drug interactions may change how your medications work or||
3076|131|I|increase your risk for serious side effects. This document does||
3076|132|I|not contain all possible drug interactions. Keep a list of all||
3076|133|I|the products you use (including prescription/nonprescription||
3076|134|I|drugs and herbal products) and share it with your doctor and||
3076|135|I|pharmacist. Do not start, stop, or change the dosage of any||
3076|136|I|medicines without your doctor's approval.||
3076|137|I|   A product that may interact with this drug is: riociguat.||
3076|138|I|   Other medications can affect the removal of theophylline from||
3076|139|I|your body, which may affect how theophylline works. Examples||
3076|140|I|include cimetidine, disulfiram, fluvoxamine, interferon,||
3076|141|I|mexiletine, rifampin, drugs used to treat seizures (such as||
3076|142|I|carbamazepine, phenytoin), St. John's wort, viloxazine, among||
3076|143|I|others.||
3076|144|I|   Cigarette/marijuana (cannabis) smoking decreases blood levels||
3076|145|I|of this medication. Tell your doctor if you smoke or if you have||
3076|146|I|recently stopped smoking.||
3076|147|I|   Theophylline is very similar to aminophylline and||
3076|148|I|oxtriphylline. Do not take medications containing aminophylline||
3076|149|I|or oxtriphylline while using theophylline.||
3076|150|I|   This medication may interfere with certain lab tests (such as||
3076|151|I|blood sugar, cholesterol, uric acid, dipyridamole-thallium||
3076|152|I|imaging tests), possibly causing false test results. Make sure||
3076|153|I|lab personnel and all your doctors know you use this drug.||
3076|154|B|||
3076|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3076|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3076|157|O|poison control center right away. US residents can call||
3076|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3076|159|O|Symptoms of overdose may include: nausea/vomiting that doesn't||
3076|160|O|stop, seizures, muscle cramps, fast/irregular heartbeat,||
3076|161|O|mental/mood changes (such as agitation, confusion), vomit that||
3076|162|O|looks like coffee grounds.||
3076|163|B|||
3076|164|N|NOTES:  Do not share this medication with others.||
3076|165|N|   Lab and/or medical tests (such as theophylline blood levels)||
3076|166|N|should be done while you are taking this medication. Keep all||
3076|167|N|medical and lab appointments. Consult your doctor for more||
3076|168|N|details.||
3076|169|B|||
3076|170|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
3076|171|D|next dose at the regular time. Do not double the dose to catch||
3076|172|D|up.||
3076|173|B|||
3076|174|R|STORAGE:  Store at room temperature away from light and moisture.||
3076|175|R|Do not store in the bathroom. Keep all medications away from||
3076|176|R|children and pets.||
3076|177|R|   Do not flush medications down the toilet or pour them into a||
3076|178|R|drain unless instructed to do so. Properly discard this product||
3076|179|R|when it is expired or no longer needed. Consult your pharmacist||
3076|180|R|or local waste disposal company.||
3076|181|B|||
3076|182|M|MEDICAL ALERT:  Your condition can cause complications in a||
3076|183|M|medical emergency. For information about enrolling in MedicAlert,||
3076|184|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3076|185|B|||
3076|186|A|Information last revised July 2025.||
3076|187|A|Copyright(c) 2025 First Databank, Inc.||
3076|188|B|||
3080|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3080|002|Z|does NOT have all possible information about this product. This||
3080|003|Z|information does not assure that this product is safe, effective,||
3080|004|Z|or appropriate for you. This information is not individual||
3080|005|Z|medical advice and does not substitute for the advice of your||
3080|006|Z|health care professional. Always ask your health care||
3080|007|Z|professional for complete information about this product and your||
3080|008|Z|specific health needs.||
3080|009|B|||
3080|010|T|MIDODRINE - ORAL||
3080|011|F|(MY-doh-dreen)||
3080|012|B|||
3080|013|C|COMMON BRAND NAME(S): ProAmatine||
3080|014|B|||
3080|015|W|WARNING:  Midodrine should only be used in carefully selected||
3080|016|W|patients. When you are lying on your back, this medication causes||
3080|017|W|a significant increase in blood pressure. Your blood pressure||
3080|018|W|will be monitored carefully during treatment.||
3080|019|B|||
3080|020|U|USES:  This medication is used for certain patients who have||
3080|021|U|symptoms of low blood pressure when standing. This condition is||
3080|022|U|also known as orthostatic hypotension. Midodrine is used in||
3080|023|U|people whose daily activities are severely affected by this||
3080|024|U|condition, even after other treatments are used (such as support||
3080|025|U|stockings). It is known as a sympathomimetic (alpha receptor||
3080|026|U|agonist) that acts on the blood vessels to raise blood pressure.||
3080|027|B|||
3080|028|H|HOW TO USE:  Take this medication by mouth with or without food||
3080|029|H|as directed by your doctor, usually 3 times daily (at least 3 to||
3080|030|H|4 hours between doses). Follow all your doctor's instructions||
3080|031|H|carefully. This drug is taken during daytime hours, when people||
3080|032|H|stand most often. This medicine should not be taken after the||
3080|033|H|evening meal or less than 4 hours before bedtime. Taking your||
3080|034|H|dose is not recommended if you plan to lie down for a long time||
3080|035|H|afterward (for example, if you plan on taking a nap).||
3080|036|H|   The dosage is based on your medical condition and response to||
3080|037|H|treatment. Usually, your doctor will start you at a low dose and||
3080|038|H|gradually increase your dose in order to reduce side effects. Do||
3080|039|H|not increase your dose or take it more often than prescribed.||
3080|040|H|   Use this medication regularly to get the most benefit from it.||
3080|041|H|To help you remember, take it at the same times each day.||
3080|042|H|   Tell your doctor if your condition lasts or gets worse. This||
3080|043|H|drug should be continued only in those people whose symptoms get||
3080|044|H|better during treatment.||
3080|045|B|||
3080|046|S|SIDE EFFECTS:  Skin tingling, chills, "goose bumps," stomach||
3080|047|S|pain, or urinary problems (strong/frequent urge to urinate,||
3080|048|S|frequent urination, trouble urinating) may occur. Less common||
3080|049|S|side effects include dry mouth, dizziness, drowsiness, trouble||
3080|050|S|sleeping, or leg cramps. If any of these effects last or get||
3080|051|S|worse, tell your doctor or pharmacist promptly.||
3080|052|S|   Remember that this medication has been prescribed because your||
3080|053|S|doctor has judged that the benefit to you is greater than the||
3080|054|S|risk of side effects. Many people using this medication do not||
3080|055|S|have serious side effects.||
3080|056|S|   This medication can cause your blood pressure to increase,||
3080|057|S|especially when you are lying down (supine hypertension). Stop||
3080|058|S|taking midodrine and contact your doctor right away if you||
3080|059|S|experience the following signs of supine hypertension: pounding||
3080|060|S|heartbeat, pounding in the ears, headache, blurred vision.||
3080|061|S|   Tell your doctor right away if you have any serious side||
3080|062|S|effects, including: slow heartbeat, unusual feeling in the chest,||
3080|063|S|fainting, pressure/fullness in the head, confusion, anxiety,||
3080|064|S|weakness, vision problems.||
3080|065|S|   A very serious allergic reaction to this drug is rare.||
3080|066|S|However, get medical help right away if you notice any symptoms||
3080|067|S|of a serious allergic reaction, including: rash, itching/swelling||
3080|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3080|069|S|breathing.||
3080|070|S|   This is not a complete list of possible side effects. If you||
3080|071|S|notice other effects not listed above, contact your doctor or||
3080|072|S|pharmacist.||
3080|073|S|   In the US -||
3080|074|S|   Call your doctor for medical advice about side effects. You||
3080|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3080|076|S|www.fda.gov/medwatch.||
3080|077|S|   In Canada - Call your doctor for medical advice about side||
3080|078|S|effects. You may report side effects to Health Canada at||
3080|079|S|1-866-234-2345.||
3080|080|B|||
3080|081|P|PRECAUTIONS:  Before taking midodrine, tell your doctor or||
3080|082|P|pharmacist if you are allergic to it; or if you have any other||
3080|083|P|allergies. This product may contain inactive ingredients, which||
3080|084|P|can cause allergic reactions or other problems. Talk to your||
3080|085|P|pharmacist for more details.||
3080|086|P|   Before using this drug, tell your doctor your entire medical||
3080|087|P|history, including: high blood pressure, a certain adrenal gland||
3080|088|P|tumor (pheochromocytoma), overactive thyroid (hyperthyroidism),||
3080|089|P|difficulty urinating (due to urinary retention or an enlarged||
3080|090|P|prostate), heart disease, liver disease, kidney disease,||
3080|091|P|diabetes.||
3080|092|P|   Get up slowly to reduce dizziness when rising from a sitting||
3080|093|P|or lying position.||
3080|094|P|   This drug may rarely make you dizzy or drowsy or blur your||
3080|095|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
3080|096|P|or drowsy. Do not drive, use machinery, or do anything that needs||
3080|097|P|alertness or clear vision until you can do it safely. Limit||
3080|098|P|alcoholic beverages. Talk to your doctor if you are using||
3080|099|P|marijuana (cannabis).||
3080|100|P|   Before having surgery, tell your doctor or dentist about all||
3080|101|P|the products you use (including prescription drugs,||
3080|102|P|nonprescription drugs, and herbal products).||
3080|103|P|   Tell your doctor if you are pregnant or plan to become||
3080|104|P|pregnant. You should not become pregnant while using midodrine.||
3080|105|P|Midodrine may harm an unborn baby. If you become pregnant, talk||
3080|106|P|to your doctor right away about the risks and benefits of this||
3080|107|P|medication.||
3080|108|P|   It is unknown if this medication passes into breast milk.||
3080|109|P|Consult your doctor before breastfeeding.||
3080|110|B|||
3080|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3080|112|I|medications work or increase your risk for serious side effects.||
3080|113|I|This document does not contain all possible drug interactions.||
3080|114|I|Keep a list of all the products you use (including||
3080|115|I|prescription/nonprescription drugs and herbal products) and share||
3080|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
3080|117|I|the dosage of any medicines without your doctor's approval.||
3080|118|I|   Some products have ingredients that could raise your blood||
3080|119|I|pressure. Tell your pharmacist what products you are using, and||
3080|120|I|ask how to use them safely (especially cough-and-cold products,||
3080|121|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
3080|122|B|||
3080|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3080|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3080|125|O|poison control center right away. US residents can call||
3080|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3080|127|O|Symptoms of overdose may include "goose bumps," difficulty||
3080|128|O|urinating, feeling cold.||
3080|129|B|||
3080|130|N|NOTES:  Do not share this medication with others.||
3080|131|N|   Blood pressure checks (lying, sitting, and standing) should be||
3080|132|N|routinely taken. Share the results with your doctor. (See also||
3080|133|N|Side Effects section.)||
3080|134|N|   You may lessen high blood pressure while lying down by||
3080|135|N|sleeping with the head of the bed lifted up.||
3080|136|N|   Lab and/or medical tests (such as kidney/liver function)||
3080|137|N|should be done while you are taking this medication. Keep all||
3080|138|N|medical and lab appointments. Consult your doctor for more||
3080|139|N|details.||
3080|140|B|||
3080|141|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3080|142|D|remember. If it is near the time of the next dose, skip the||
3080|143|D|missed dose. Take your next dose at the regular time. Do not||
3080|144|D|double the dose to catch up.||
3080|145|B|||
3080|146|R|STORAGE:  Store at room temperature away from light and moisture.||
3080|147|R|Do not store in the bathroom. Keep all medications away from||
3080|148|R|children and pets.||
3080|149|R|   Do not flush medications down the toilet or pour them into a||
3080|150|R|drain unless instructed to do so. Properly discard this product||
3080|151|R|when it is expired or no longer needed. Consult your pharmacist||
3080|152|R|or local waste disposal company.||
3080|153|B|||
3080|154|A|Information last revised November 2024.||
3080|155|A|Copyright(c) 2025 First Databank, Inc.||
3080|156|B|||
3083|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3083|002|Z|does NOT have all possible information about this product. This||
3083|003|Z|information does not assure that this product is safe, effective,||
3083|004|Z|or appropriate for you. This information is not individual||
3083|005|Z|medical advice and does not substitute for the advice of your||
3083|006|Z|health care professional. Always ask your health care||
3083|007|Z|professional for complete information about this product and your||
3083|008|Z|specific health needs.||
3083|009|B|||
3083|010|T|LODOXAMIDE - OPHTHALMIC||
3083|011|F|(low-DOX-uh-mide)||
3083|012|B|||
3083|013|C|COMMON BRAND NAME(S): Alomide||
3083|014|B|||
3083|015|U|USES:  This medication is used to treat certain allergic eye||
3083|016|U|conditions (vernal keratoconjunctivitis, vernal conjunctivitis,||
3083|017|U|vernal keratitis). It prevents itching of the eyes that can occur||
3083|018|U|with these conditions. Lodoxamide is known as a mast cell||
3083|019|U|stabilizer. It works by blocking certain natural substances||
3083|020|U|(histamine, leukotriene) that cause allergic symptoms.||
3083|021|B|||
3083|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
3083|023|H|directed by your doctor, usually 4 times daily. Treatment may be||
3083|024|H|continued for as long as 3 months.||
3083|025|H|   To apply eye drops, wash your hands first. To avoid||
3083|026|H|contamination, do not touch the dropper tip or let it touch your||
3083|027|H|eye or any other surface.||
3083|028|H|   It is best to not wear contact lenses while using this||
3083|029|H|medication.||
3083|030|H|   Tilt your head back, look upward, and pull down the lower||
3083|031|H|eyelid to make a pouch. Hold the dropper directly over the eye||
3083|032|H|and place 1 drop into the pouch. Look downward and gently close||
3083|033|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
3083|034|H|the eye near the nose and apply gentle pressure. This will||
3083|035|H|prevent the medication from draining away from the eye. Try not||
3083|036|H|to blink and do not rub the eye. Repeat these steps if your dose||
3083|037|H|is for more than 1 drop and for the other eye if so directed.||
3083|038|H|   Do not rinse the dropper. Replace the dropper cap tightly||
3083|039|H|after each use.||
3083|040|H|   If you are using another kind of eye medication (such as drops||
3083|041|H|or ointments), wait at least 5 minutes before applying other||
3083|042|H|medications. Use eye drops before eye ointments to allow the eye||
3083|043|H|drops to enter the eye.||
3083|044|H|   Wait several minutes for your vision to clear before driving||
3083|045|H|or operating machinery.||
3083|046|H|   Use this medication regularly in order to get the most benefit||
3083|047|H|from it. To help you remember, use it at the same times each day.||
3083|048|H|Keep using it for the full time prescribed.||
3083|049|H|   It may take up to several days of continued use to see a||
3083|050|H|relief in symptoms. If immediate relief of symptoms (itching) is||
3083|051|H|needed, use other quick-relief medication (such as eye drops||
3083|052|H|containing antihistamines, decongestants, or nonsteroidal||
3083|053|H|anti-inflammatory drugs-NSAIDs) along with lodoxamide as directed||
3083|054|H|by your doctor. Tell your doctor if your condition lasts or gets||
3083|055|H|worse.||
3083|056|B|||
3083|057|S|SIDE EFFECTS:  Eye burning/stinging/discomfort, feeling as if||
3083|058|S|something is in your eye, dry nose, sneezing, headache,||
3083|059|S|dizziness, drowsiness, blurred vision, watery eyes, dry eyes,||
3083|060|S|sticky feeling in the eye, or crusting in the corner of the eye||
3083|061|S|or on the eyelid may occur. If any of these effects last or get||
3083|062|S|worse, tell your doctor or pharmacist promptly.||
3083|063|S|   Remember that this medication has been prescribed because your||
3083|064|S|doctor has judged that the benefit to you is greater than the||
3083|065|S|risk of side effects. Many people using this medication do not||
3083|066|S|have serious side effects.||
3083|067|S|   Tell your doctor right away if you have any serious side||
3083|068|S|effects, including: eye pain, swelling in or around the eyes,||
3083|069|S|warm feeling in the eye, vision changes.||
3083|070|S|   A very serious allergic reaction to this drug is rare.||
3083|071|S|However, get medical help right away if you notice any symptoms||
3083|072|S|of a serious allergic reaction, including: rash, itching/swelling||
3083|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3083|074|S|breathing.||
3083|075|S|   This is not a complete list of possible side effects. If you||
3083|076|S|notice other effects not listed above, contact your doctor or||
3083|077|S|pharmacist.||
3083|078|S|   In the US -||
3083|079|S|   Call your doctor for medical advice about side effects. You||
3083|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3083|081|S|www.fda.gov/medwatch.||
3083|082|S|   In Canada - Call your doctor for medical advice about side||
3083|083|S|effects. You may report side effects to Health Canada at||
3083|084|S|1-866-234-2345.||
3083|085|B|||
3083|086|P|PRECAUTIONS:  Before using lodoxamide, tell your doctor or||
3083|087|P|pharmacist if you are allergic to it; or if you have any other||
3083|088|P|allergies. This product may contain inactive ingredients (such as||
3083|089|P|preservatives like benzalkonium chloride), which can cause||
3083|090|P|allergic reactions or other problems. Talk to your pharmacist for||
3083|091|P|more details.||
3083|092|P|   Before using this medication, tell your doctor or pharmacist||
3083|093|P|your medical history.||
3083|094|P|   After you apply this drug, your vision may become temporarily||
3083|095|P|blurred. This drug may also rarely make you dizzy or drowsy.||
3083|096|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3083|097|P|drowsy. Do not drive, use machinery, or do anything that needs||
3083|098|P|alertness or clear vision until you can do it safely. Limit||
3083|099|P|alcoholic beverages. Talk to your doctor if you are using||
3083|100|P|marijuana (cannabis).||
3083|101|P|   During pregnancy, this medication should be used only when||
3083|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
3083|103|P|   It is unknown if this drug passes into breast milk. Consult||
3083|104|P|your doctor before breastfeeding.||
3083|105|B|||
3083|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3083|107|I|medications work or increase your risk for serious side effects.||
3083|108|I|This document does not contain all possible drug interactions.||
3083|109|I|Keep a list of all the products you use (including||
3083|110|I|prescription/nonprescription drugs and herbal products) and share||
3083|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
3083|112|I|the dosage of any medicines without your doctor's approval.||
3083|113|B|||
3083|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3083|115|O|has overdosed and has serious symptoms such as passing out or||
3083|116|O|trouble breathing, call 911. Otherwise, call a poison control||
3083|117|O|center right away. US residents can call 1-800-222-1222. Canada||
3083|118|O|residents can call 1-844-764-7669. Symptoms after swallowing||
3083|119|O|lodoxamide may include: flushing, feeling of warmth, unusual||
3083|120|O|tiredness, sweating, diarrhea.||
3083|121|B|||
3083|122|N|NOTES:  Avoid allergens that may be the cause of your allergies.||
3083|123|N|Some common allergens that cause allergic eye conditions include||
3083|124|N|pollen, grasses, weeds, dust mites, and pet dander.||
3083|125|N|   Do not share this medication with others.||
3083|126|N|   This medication has been prescribed for your current condition||
3083|127|N|only. Do not use it later for another condition unless directed||
3083|128|N|to do so by your doctor. A different medication may be necessary||
3083|129|N|in that case.||
3083|130|B|||
3083|131|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3083|132|D|If it is near the time of the next dose, skip the missed dose.||
3083|133|D|Use your next dose at the regular time. Do not double the dose to||
3083|134|D|catch up.||
3083|135|B|||
3083|136|R|STORAGE:  Store at room temperature. Keep all medications away||
3083|137|R|from children and pets.||
3083|138|R|   Do not flush medications down the toilet or pour them into a||
3083|139|R|drain unless instructed to do so. Properly discard this product||
3083|140|R|when it is expired or no longer needed. Consult your pharmacist||
3083|141|R|or local waste disposal company.||
3083|142|B|||
3083|143|A|Information last revised May 2024.||
3083|144|A|Copyright(c) 2025 First Databank, Inc.||
3083|145|B|||
3087|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3087|002|Z|does NOT have all possible information about this product. This||
3087|003|Z|information does not assure that this product is safe, effective,||
3087|004|Z|or appropriate for you. This information is not individual||
3087|005|Z|medical advice and does not substitute for the advice of your||
3087|006|Z|health care professional. Always ask your health care||
3087|007|Z|professional for complete information about this product and your||
3087|008|Z|specific health needs.||
3087|009|B|||
3087|010|T|CARISOPRODOL/ASPIRIN/CODEINE - ORAL||
3087|011|F|(kar-iss-oh-PRO-dole/AS-pir-in/KOE-deen)||
3087|012|B|||
3087|013|C|COMMON BRAND NAME(S): Soma Compound with Codeine||
3087|014|B|||
3087|015|W|WARNING:  Codeine has a risk for abuse and addiction, which can||
3087|016|W|lead to overdose and death. Codeine may also cause severe,||
3087|017|W|possibly fatal, breathing problems. To lower your risk, your||
3087|018|W|doctor should have you take the smallest dose of codeine that||
3087|019|W|works, and take it for the shortest possible time. See also How||
3087|020|W|to Use section for more information about addiction.||
3087|021|W|   Ask your doctor or pharmacist if you should have medication||
3087|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
3087|023|W|Teach your family or household members about the signs of an||
3087|024|W|opioid overdose and how to treat it.||
3087|025|W|   The risk for severe breathing problems is higher when you||
3087|026|W|start this medication and after a dose increase, or if you take||
3087|027|W|the wrong dose/strength. Taking this medication with alcohol or||
3087|028|W|other drugs that can cause drowsiness or breathing problems may||
3087|029|W|cause very serious side effects, including death. Also, other||
3087|030|W|medications can affect the removal of codeine from your body,||
3087|031|W|which may affect how codeine works. Be sure you know how to take||
3087|032|W|this medication and what other drugs you should avoid taking with||
3087|033|W|it. See also Drug Interactions section. Get medical help right||
3087|034|W|away if any of these very serious side effects occur:||
3087|035|W|slow/shallow breathing, unusual lightheadedness, severe||
3087|036|W|drowsiness/dizziness, difficulty waking up.||
3087|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
3087|038|W|or abuse. If someone accidentally swallows this medication, get||
3087|039|W|medical help right away.||
3087|040|W|   Children younger than 18 years should not use products that||
3087|041|W|contain codeine. Some children are more sensitive to codeine and||
3087|042|W|have had very serious (rarely fatal) breathing problems such as||
3087|043|W|slow/shallow breathing (see also Side Effects section). The risk||
3087|044|W|is greater in children who are obese or have breathing problems,||
3087|045|W|or after certain surgeries (including tonsil/adenoid removal).||
3087|046|W|Talk with your doctor or pharmacist about the risks and benefits||
3087|047|W|of this medication.||
3087|048|B|||
3087|049|U|USES:  See also Warning section.||
3087|050|U|   This product is used short-term to treat muscle pain and||
3087|051|U|discomfort. It is usually used along with rest, physical therapy,||
3087|052|U|and other treatments. Carisoprodol helps to relax the muscles.||
3087|053|U|Aspirin helps to decrease pain and swelling. Codeine is an opioid||
3087|054|U|pain reliever that works in the brain to change how your body||
3087|055|U|feels and responds to pain.||
3087|056|B|||
3087|057|H|HOW TO USE:  Read the Medication Guide provided by your||
3087|058|H|pharmacist before you start taking this product and each time you||
3087|059|H|get a refill. If you have any questions, ask your doctor or||
3087|060|H|pharmacist.||
3087|061|H|   Take this medication by mouth with or without food as directed||
3087|062|H|by your doctor. Do not increase your dose or use this drug more||
3087|063|H|often or for longer than prescribed. Your condition will not||
3087|064|H|improve any faster, and your risk of side effects will increase.||
3087|065|H|Take this medication with a full glass of water (8 ounces/240||
3087|066|H|milliliters) unless your doctor directs you otherwise. Do not lie||
3087|067|H|down for at least 10 minutes after taking this medication. If you||
3087|068|H|have stomach upset or nausea, it may help to take this drug with||
3087|069|H|food. Ask your doctor or pharmacist about other ways to decrease||
3087|070|H|nausea (such as lying down for 1 to 2 hours with as little head||
3087|071|H|movement as possible).||
3087|072|H|   The dosage is based on your medical condition and response to||
3087|073|H|treatment. This medication should only be used short-term (for 3||
3087|074|H|weeks or less) unless directed by your doctor. Use the smallest||
3087|075|H|effective dose.||
3087|076|H|   Pain medications work best if they are used as the first signs||
3087|077|H|of pain occur. If you wait until the symptoms have worsened, the||
3087|078|H|medication may not work as well.||
3087|079|H|   If you suddenly stop using this medication, you may have||
3087|080|H|withdrawal symptoms (such as stomach cramps, trouble sleeping,||
3087|081|H|headache, restlessness, nausea, sweating, diarrhea, watering||
3087|082|H|eyes, runny nose). To help prevent withdrawal, your doctor may||
3087|083|H|lower your dose slowly. Withdrawal is more likely if you have||
3087|084|H|used this medication for a long time or in high doses. Tell your||
3087|085|H|doctor or pharmacist right away if you have withdrawal.||
3087|086|H|   When this medication is used for a long time, it may not work||
3087|087|H|as well. Talk with your doctor if this medication stops working||
3087|088|H|well.||
3087|089|H|   Though it helps many people, this medication may sometimes||
3087|090|H|cause addiction. This risk may be higher if you have a||
3087|091|H|mental/mood disorder or a substance use disorder (such as overuse||
3087|092|H|of or addiction to drugs/alcohol). Take this medication exactly||
3087|093|H|as prescribed to lower the risk of addiction. Ask your doctor or||
3087|094|H|pharmacist for more details.||
3087|095|H|   Tell your doctor if your condition lasts after 2 to 3 weeks or||
3087|096|H|if it gets worse, or if you have any new pain.||
3087|097|B|||
3087|098|S|SIDE EFFECTS:  See also Warning section.||
3087|099|S|   Drowsiness, dizziness, lightheadedness, headache, stomach||
3087|100|S|upset, constipation, nausea/vomiting, or heartburn may occur. If||
3087|101|S|any of these effects last or get worse, tell your doctor or||
3087|102|S|pharmacist promptly.||
3087|103|S|   To prevent constipation, eat dietary fiber, drink enough||
3087|104|S|water, and exercise. You may also need to take a laxative. Ask||
3087|105|S|your pharmacist which type of laxative is right for you.||
3087|106|S|   To reduce the risk of dizziness and lightheadedness, get up||
3087|107|S|slowly when rising from a sitting or lying position.||
3087|108|S|   Remember that this medication has been prescribed because your||
3087|109|S|doctor has judged that the benefit to you is greater than the||
3087|110|S|risk of side effects. Many people using this medication do not||
3087|111|S|have serious side effects.||
3087|112|S|   Tell your doctor right away if you have any serious side||
3087|113|S|effects, including: trouble swallowing, nausea/vomiting that||
3087|114|S|doesn't stop, easy bruising/bleeding, dark urine, yellowing||
3087|115|S|eyes/skin, hearing problems (such as ringing in the ears, hearing||
3087|116|S|loss), signs of kidney problems (such as change in the amount of||
3087|117|S|urine), fast/pounding heartbeat, difficulty urinating,||
3087|118|S|interrupted breathing during sleep (sleep apnea), mental/mood||
3087|119|S|changes (such as agitation, hallucinations), signs of your||
3087|120|S|adrenal glands not working well (such as loss of appetite,||
3087|121|S|unusual tiredness, weight loss).||
3087|122|S|   Get medical help right away if you have any very serious side||
3087|123|S|effects, including: fainting, seizures.||
3087|124|S|   Codeine is changed into a strong opioid drug (morphine) in||
3087|125|S|your body. In some people, this change happens faster and more||
3087|126|S|completely than usual, which increases the risk of very serious||
3087|127|S|side effects. Get medical help right away if you notice any of||
3087|128|S|the following: slow/shallow breathing, severe||
3087|129|S|drowsiness/difficulty waking up, confusion.||
3087|130|S|   This drug may rarely cause serious (rarely fatal) bleeding||
3087|131|S|from the stomach or intestines. If you notice any of the||
3087|132|S|following unlikely but serious side effects, stop taking this||
3087|133|S|medication and consult your doctor or pharmacist right away:||
3087|134|S|stomach/abdominal pain that doesn't go away, black stool, vomit||
3087|135|S|that looks like coffee grounds.||
3087|136|S|   A very serious allergic reaction to this drug is rare.||
3087|137|S|However, get medical help right away if you notice any symptoms||
3087|138|S|of a serious allergic reaction, including: fever, swollen lymph||
3087|139|S|nodes, rash, itching/swelling (especially of the||
3087|140|S|face/tongue/throat), severe dizziness, trouble breathing.||
3087|141|S|   This is not a complete list of possible side effects. If you||
3087|142|S|notice other effects not listed above, contact your doctor or||
3087|143|S|pharmacist.||
3087|144|S|   In the US -||
3087|145|S|   Call your doctor for medical advice about side effects. You||
3087|146|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3087|147|S|www.fda.gov/medwatch.||
3087|148|S|   In Canada - Call your doctor for medical advice about side||
3087|149|S|effects. You may report side effects to Health Canada at||
3087|150|S|1-866-234-2345.||
3087|151|B|||
3087|152|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
3087|153|P|pharmacist if you are allergic to codeine, carisoprodol, or||
3087|154|P|aspirin; or to related medications such as meprobamate, tybamate,||
3087|155|P|or mebutamate; or to other opioid pain medications (such as||
3087|156|P|morphine); or to nonsteroidal anti-inflammatory drugs-NSAIDs||
3087|157|P|(such as ibuprofen); or to other salicylates (such as choline||
3087|158|P|salicylate); or if you have any other allergies. This product may||
3087|159|P|contain inactive ingredients, which can cause allergic reactions||
3087|160|P|or other problems. Talk to your pharmacist for more details.||
3087|161|P|   Before using this medication, tell your doctor or pharmacist||
3087|162|P|your medical history, especially of: asthma (including a history||
3087|163|P|of worsening breathing with runny/stuffy nose after taking||
3087|164|P|aspirin or other NSAIDs), growths in the nose (nasal polyps),||
3087|165|P|stomach/intestine/esophagus problems (such as ulcers, heartburn,||
3087|166|P|blockage, constipation, diarrhea due to infection, paralytic||
3087|167|P|ileus), a certain blood disorder (acute intermittent porphyria),||
3087|168|P|brain disorders (such as head injury, tumor, seizures), breathing||
3087|169|P|problems (such as sleep apnea, chronic obstructive pulmonary||
3087|170|P|disease-COPD), kidney disease, liver disease, bleeding/clotting||
3087|171|P|disorders (such as hemophilia, von Willebrand disease,||
3087|172|P|thrombocytopenia), certain enzyme deficiencies (such as G6PD or||
3087|173|P|pyruvate kinase deficiency), gout, personal or family history of||
3087|174|P|a substance use disorder (such as overuse of or addiction to||
3087|175|P|drugs/alcohol), mental/mood disorders (such as confusion,||
3087|176|P|depression, thoughts of suicide), difficulty urinating (such as||
3087|177|P|due to enlarged prostate), gallbladder disease, disease of the||
3087|178|P|pancreas (pancreatitis), obesity.||
3087|179|P|   Before having surgery, tell your doctor or dentist about all||
3087|180|P|the products you use (including prescription drugs,||
3087|181|P|nonprescription drugs, and herbal products).||
3087|182|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3087|183|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3087|184|P|machinery, or do anything that needs alertness until you can do||
3087|185|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
3087|186|P|are using marijuana (cannabis).||
3087|187|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
3087|188|P|and tobacco, especially when combined with this medicine, may||
3087|189|P|increase your risk for stomach bleeding. Avoid alcohol and stop||
3087|190|P|smoking. Consult your doctor or pharmacist for more information.||
3087|191|P|   This drug contains aspirin. Children and teenagers less than||
3087|192|P|18 years old should not take aspirin if they have chickenpox,||
3087|193|P|flu, or any undiagnosed illness or if they have recently received||
3087|194|P|a vaccine. In these cases, taking aspirin increases the risk of||
3087|195|P|Reye's syndrome, a rare but serious illness.||
3087|196|P|   Older adults may be more sensitive to the side effects of this||
3087|197|P|drug, especially stomach/intestinal bleeding and ulcers,||
3087|198|P|dizziness, drowsiness, weakness, confusion, slow/shallow||
3087|199|P|breathing, and difficulty urinating. Dizziness, drowsiness, and||
3087|200|P|confusion can increase the risk of falling.||
3087|201|P|   Before using this medication, women of childbearing age should||
3087|202|P|talk with their doctor(s) about the benefits and risks. Tell your||
3087|203|P|doctor if you are pregnant or if you plan to become pregnant.||
3087|204|P|This medication may harm an unborn baby and cause problems with||
3087|205|P|normal labor/delivery. It is not recommended for use in pregnancy||
3087|206|P|from 20 weeks until delivery. If your doctor decides that you||
3087|207|P|need to use this medication between 20 and 30 weeks of pregnancy,||
3087|208|P|you should use the lowest effective dose for the shortest||
3087|209|P|possible time. You should not use this medication after 30 weeks||
3087|210|P|of pregnancy.||
3087|211|P|   This medication passes into breast milk and may have||
3087|212|P|undesirable effects on a nursing infant. Breastfeeding is not||
3087|213|P|recommended while using this medication. Consult your doctor||
3087|214|P|before breastfeeding.||
3087|215|B|||
3087|216|I|DRUG INTERACTIONS:  See also Warning section.||
3087|217|I|   Drug interactions may change how your medications work or||
3087|218|I|increase your risk for serious side effects. This document does||
3087|219|I|not contain all possible drug interactions. Keep a list of all||
3087|220|I|the products you use (including prescription/nonprescription||
3087|221|I|drugs and herbal products) and share it with your doctor and||
3087|222|I|pharmacist. Do not start, stop, or change the dosage of any||
3087|223|I|medicines without your doctor's approval.||
3087|224|I|   Some products that may interact with this drug include:||
3087|225|I|certain pain medications (mixed opioid agonist-antagonists such||
3087|226|I|as butorphanol, nalbuphine, pentazocine), corticosteroids (such||
3087|227|I|as prednisone), dichlorphenamide, mifepristone, naltrexone,||
3087|228|I|samidorphan.||
3087|229|I|   This medication may increase the risk of bleeding when taken||
3087|230|I|with other drugs that also may cause bleeding. Examples include||
3087|231|I|anti-platelet drugs such as clopidogrel/ticagrelor, "blood||
3087|232|I|thinners" such as dabigatran/enoxaparin/warfarin, among others.||
3087|233|I|   Check all prescription and nonprescription medicine labels||
3087|234|I|carefully since many medications contain pain relievers/fever||
3087|235|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
3087|236|I|naproxen). These drugs are similar to this medication and may||
3087|237|I|increase your risk of side effects if taken together. Ask your||
3087|238|I|doctor or pharmacist for more details.||
3087|239|I|   The risk of serious side effects (such as slow/shallow||
3087|240|I|breathing, severe drowsiness/dizziness) may be increased if this||
3087|241|I|medication is taken with other products that may also cause||
3087|242|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
3087|243|I|if you are taking other products such as other opioid pain or||
3087|244|I|cough relievers (such as morphine, hydrocodone), alcohol,||
3087|245|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
3087|246|I|alprazolam, lorazepam, zolpidem), other muscle relaxants (such as||
3087|247|I|cyclobenzaprine, methocarbamol), or antihistamines (such as||
3087|248|I|cetirizine, diphenhydramine).||
3087|249|I|   Check the labels on all your medicines (such as allergy or||
3087|250|I|cough-and-cold products) because they may contain ingredients||
3087|251|I|that cause drowsiness. Ask your pharmacist about using those||
3087|252|I|products safely.||
3087|253|I|   Other medications can affect the removal of this product from||
3087|254|I|your body, which may affect how this product works. Examples||
3087|255|I|include azole antifungals (such as ketoconazole), bupropion,||
3087|256|I|fluoxetine, macrolide antibiotics (such as erythromycin),||
3087|257|I|paroxetine, quinidine, rifamycins (such as rifabutin, rifampin),||
3087|258|I|ritonavir, certain drugs used to treat seizures (such as||
3087|259|I|carbamazepine, phenytoin), among others.||
3087|260|I|   This medication may interfere with certain lab tests (such as||
3087|261|I|amylase/lipase levels), possibly causing false test results. Make||
3087|262|I|sure lab personnel and all your doctors know you use this drug.||
3087|263|B|||
3087|264|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3087|265|O|as passing out or trouble breathing, give them naloxone or||
3087|266|O|nalmefene if available, then call 911. If the person is awake and||
3087|267|O|has no symptoms, call a poison control center right away. US||
3087|268|O|residents can call 1-800-222-1222. Canada residents can call||
3087|269|O|1-844-764-7669. Symptoms of overdose may include: severe||
3087|270|O|drowsiness/dizziness, slow/shallow breathing, seizures, ringing||
3087|271|O|in the ears, mental/mood changes (such as confusion,||
3087|272|O|hallucinations), inability to move your legs/arms, shaky/unsteady||
3087|273|O|movement, vision changes (such as blurred vision), coma.||
3087|274|B|||
3087|275|N|NOTES:  Do not share this medication with others. Sharing it is||
3087|276|N|against the law.||
3087|277|N|   This medication has been prescribed for your current condition||
3087|278|N|only. Do not use it later for another condition unless your||
3087|279|N|doctor directs you to do so. A different medication may be||
3087|280|N|necessary in that case.||
3087|281|B|||
3087|282|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3087|283|D|remember. If it is near the time of the next dose, skip the||
3087|284|D|missed dose. Take your next dose at the regular time. Do not||
3087|285|D|double the dose to catch up.||
3087|286|B|||
3087|287|R|STORAGE:  Store at room temperature away from light and moisture.||
3087|288|R|Do not store in the bathroom. Keep all medications away from||
3087|289|R|children and pets.||
3087|290|R|   Do not flush medications down the toilet or pour them into a||
3087|291|R|drain unless instructed to do so. Properly discard this product||
3087|292|R|when it is expired or no longer needed. Consult your pharmacist||
3087|293|R|or local waste disposal company.||
3087|294|B|||
3087|295|A|Information last revised August 2025.||
3087|296|A|Copyright(c) 2025 First Databank, Inc.||
3087|297|B|||
3094|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3094|002|Z|does NOT have all possible information about this product. This||
3094|003|Z|information does not assure that this product is safe, effective,||
3094|004|Z|or appropriate for you. This information is not individual||
3094|005|Z|medical advice and does not substitute for the advice of your||
3094|006|Z|health care professional. Always ask your health care||
3094|007|Z|professional for complete information about this product and your||
3094|008|Z|specific health needs.||
3094|009|B|||
3094|010|T|AROMATIC AMMONIA - INHALATION||
3094|011|F|(a-MONE-ya)||
3094|012|B|||
3094|013|U|USES:  This product is used to treat or prevent fainting. It||
3094|014|U|works by increasing the body's urge to breathe.||
3094|015|B|||
3094|016|H|HOW TO USE:  Use this product as directed. Follow all directions||
3094|017|H|on the product package, or use as directed by your doctor. Throw||
3094|018|H|away product after use. If you have any questions, ask your||
3094|019|H|doctor or pharmacist.||
3094|020|H|   This product is flammable. Avoid smoking or being near open||
3094|021|H|flames while using the product.||
3094|022|H|   Use this medication with care. Avoid getting the medication in||
3094|023|H|your eyes or on your skin. This medication may cause||
3094|024|H|burning/irritation to the eyes/skin. If you do get the medication||
3094|025|H|in the eyes, flush with water for about 20 minutes and tell your||
3094|026|H|doctor right away. If you get this medication on your skin, flush||
3094|027|H|with plenty of water and tell your doctor if the||
3094|028|H|burning/irritation lasts.||
3094|029|H|   If your condition lasts or gets worse, if your face is||
3094|030|H|flushed, or if you think you may have a serious medical problem,||
3094|031|H|get medical help right away.||
3094|032|B|||
3094|033|S|SIDE EFFECTS:  Coughing or watery eyes may occur. If any of these||
3094|034|S|effects last or get worse, contact your doctor or pharmacist||
3094|035|S|promptly.||
3094|036|S|   If your doctor has directed you to use this medication,||
3094|037|S|remember that your doctor has judged that the benefit to you is||
3094|038|S|greater than the risk of side effects. Many people using this||
3094|039|S|medication do not have serious side effects.||
3094|040|S|   Tell your doctor right away if you have any serious side||
3094|041|S|effects, including: vomiting, diarrhea, headache.||
3094|042|S|   Get medical help right away if you have any very serious side||
3094|043|S|effects, including: trouble breathing, eye pain, vision changes.||
3094|044|S|   A very serious allergic reaction to this drug is rare.||
3094|045|S|However, get medical help right away if you notice any symptoms||
3094|046|S|of a serious allergic reaction, including: rash, itching/swelling||
3094|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3094|048|S|breathing.||
3094|049|S|   This is not a complete list of possible side effects. If you||
3094|050|S|notice other effects not listed above, contact your doctor or||
3094|051|S|pharmacist.||
3094|052|S|   In the US -||
3094|053|S|   Call your doctor for medical advice about side effects. You||
3094|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3094|055|S|www.fda.gov/medwatch.||
3094|056|S|   In Canada - Call your doctor for medical advice about side||
3094|057|S|effects. You may report side effects to Health Canada at||
3094|058|S|1-866-234-2345.||
3094|059|B|||
3094|060|P|PRECAUTIONS:  Before using aromatic ammonia, tell your doctor or||
3094|061|P|pharmacist if you are allergic to it; or if you have any other||
3094|062|P|allergies. This product may contain inactive ingredients, which||
3094|063|P|can cause allergic reactions or other problems. Talk to your||
3094|064|P|pharmacist for more details.||
3094|065|P|   If you have any of the following health problems, consult your||
3094|066|P|doctor or pharmacist before using this product: breathing||
3094|067|P|problems (such as asthma, bronchitis, emphysema).||
3094|068|P|   During pregnancy, this product should be used only when||
3094|069|P|clearly needed. Discuss the risks and benefits with your doctor.||
3094|070|P|   It is unknown if this product passes into breast milk. Consult||
3094|071|P|your doctor before breastfeeding.||
3094|072|B|||
3094|073|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3094|074|I|medications work or increase your risk for serious side effects.||
3094|075|I|This document does not contain all possible drug interactions.||
3094|076|I|Keep a list of all the products you use (including||
3094|077|I|prescription/nonprescription drugs and herbal products) and share||
3094|078|I|it with your doctor and pharmacist. Do not start, stop, or change||
3094|079|I|the dosage of any medicines without your doctor's approval.||
3094|080|B|||
3094|081|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3094|082|O|has overdosed and has serious symptoms such as passing out or||
3094|083|O|trouble breathing, call 911. Otherwise, call a poison control||
3094|084|O|center right away. US residents can call 1-800-222-1222. Canada||
3094|085|O|residents can call 1-844-764-7669.||
3094|086|B|||
3094|087|N|NOTES:  Keep all medical and lab appointments.||
3094|088|N|   Fainting may be a sign of a serious medical condition,||
3094|089|N|especially in older people and people with heart problems. Check||
3094|090|N|with your doctor as soon as possible after fainting.||
3094|091|B|||
3094|092|D|MISSED DOSE:  Not applicable.||
3094|093|B|||
3094|094|R|STORAGE:  Refer to storage information printed on the package.||
3094|095|R|Protect from heat or open flame. If you have any questions about||
3094|096|R|storage, ask your pharmacist. Keep all medications away from||
3094|097|R|children and pets.||
3094|098|R|   Do not flush medications down the toilet or pour them into a||
3094|099|R|drain unless instructed to do so. Properly discard this product||
3094|100|R|when it is expired or no longer needed. Consult your pharmacist||
3094|101|R|or local waste disposal company.||
3094|102|B|||
3094|103|A|Information last revised July 2025.||
3094|104|A|Copyright(c) 2025 First Databank, Inc.||
3094|105|B|||
3095|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3095|002|Z|does NOT have all possible information about this product. This||
3095|003|Z|information does not assure that this product is safe, effective,||
3095|004|Z|or appropriate for you. This information is not individual||
3095|005|Z|medical advice and does not substitute for the advice of your||
3095|006|Z|health care professional. Always ask your health care||
3095|007|Z|professional for complete information about this product and your||
3095|008|Z|specific health needs.||
3095|009|B|||
3095|010|T|PAROXETINE CONTROLLED-RELEASE - ORAL||
3095|011|F|(pa-ROX-e-teen)||
3095|012|B|||
3095|013|C|COMMON BRAND NAME(S): Paxil CR||
3095|014|B|||
3095|015|W|WARNING:  Antidepressant medications are used to treat a variety||
3095|016|W|of conditions, including depression and other mental/mood||
3095|017|W|disorders. These medications can help prevent suicidal||
3095|018|W|thoughts/attempts and provide other important benefits. However,||
3095|019|W|studies have shown that a small number of people (especially||
3095|020|W|people younger than 25) who take antidepressants for any||
3095|021|W|condition may experience worsening depression, other mental/mood||
3095|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
3095|023|W|talk with the doctor about the risks and benefits of||
3095|024|W|antidepressant medication (especially for people younger than||
3095|025|W|25), even if treatment is not for a mental/mood condition.||
3095|026|W|   Tell the doctor right away if you notice worsening||
3095|027|W|depression/other psychiatric conditions, unusual behavior changes||
3095|028|W|(including possible suicidal thoughts/attempts), or other||
3095|029|W|mental/mood changes (including new/worsening anxiety, panic||
3095|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
3095|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
3095|032|W|especially watchful for these symptoms when a new antidepressant||
3095|033|W|is started or when the dose is changed.||
3095|034|B|||
3095|035|U|USES:  This medication is used to treat certain mental/mood||
3095|036|U|disorders (such as depression, panic attacks, anxiety disorders).||
3095|037|U|It is also used to treat a severe form of premenstrual syndrome||
3095|038|U|(premenstrual dysphoric disorder). Paroxetine belongs to a class||
3095|039|U|of drugs known as selective serotonin reuptake inhibitors||
3095|040|U|(SSRIs). It works by helping to restore the balance of a certain||
3095|041|U|natural substance (serotonin) in the brain.||
3095|042|B|||
3095|043|V|OTHER USES:  This section contains uses of this drug that are not||
3095|044|V|listed in the approved professional labeling for the drug but||
3095|045|V|that may be prescribed by your health care professional. Use this||
3095|046|V|drug for a condition that is listed in this section only if it||
3095|047|V|has been so prescribed by your health care professional.||
3095|048|V|   This drug may also be used for other mental/mood disorders||
3095|049|V|(such as obsessive-compulsive disorder-OCD, post-traumatic stress||
3095|050|V|disorder). It may also be used for hot flashes that occur with||
3095|051|V|menopause.||
3095|052|B|||
3095|053|H|HOW TO USE:  Read the Medication Guide and, if available, the||
3095|054|H|Patient Information Leaflet provided by your pharmacist before||
3095|055|H|you start taking paroxetine and each time you get a refill. If||
3095|056|H|you have any questions, ask your doctor or pharmacist.||
3095|057|H|   Take this medication by mouth with or without food as directed||
3095|058|H|by your doctor, usually once daily in the morning. Taking this||
3095|059|H|medication with food may decrease nausea. If this medication||
3095|060|H|makes you sleepy during the day, talk to your doctor about taking||
3095|061|H|it in the evening. Swallow the tablets whole. Do not crush or||
3095|062|H|chew the tablets. Doing so can release all of the drug at once,||
3095|063|H|increasing the risk of side effects.||
3095|064|H|   The dosage is based on your medical condition, response to||
3095|065|H|treatment, age, and other medications you may be taking. Be sure||
3095|066|H|to tell your doctor and pharmacist about all the products you use||
3095|067|H|(including prescription drugs, nonprescription drugs, and herbal||
3095|068|H|products). To reduce your risk of side effects, your doctor may||
3095|069|H|start you at a low dose and gradually increase your dose. Follow||
3095|070|H|your doctor's instructions carefully. Do not increase your dose||
3095|071|H|or use this drug more often or for longer than prescribed. Your||
3095|072|H|condition will not improve any faster, and your risk of side||
3095|073|H|effects will increase. Take this medication regularly to get the||
3095|074|H|most benefit from it. To help you remember, take it at the same||
3095|075|H|time each day.||
3095|076|H|   If you are taking paroxetine for premenstrual problems, your||
3095|077|H|doctor may direct you to take it every day of the month or just||
3095|078|H|for the 2 weeks before your period through the first full day of||
3095|079|H|your period.||
3095|080|H|   Keep taking this medication even if you feel well. Do not stop||
3095|081|H|taking this medication without consulting your doctor. Some||
3095|082|H|conditions may become worse when this drug is suddenly stopped.||
3095|083|H|Also, you may experience symptoms such as mood swings, headache,||
3095|084|H|tiredness, sleep changes, and brief feelings similar to electric||
3095|085|H|shock. To prevent these symptoms while you are stopping treatment||
3095|086|H|with this drug, your doctor may reduce your dose gradually.||
3095|087|H|Consult your doctor or pharmacist for more details. Report any||
3095|088|H|new or worsening symptoms right away.||
3095|089|H|   It may take up to several weeks before you get the full||
3095|090|H|benefit of this drug.||
3095|091|H|   Tell your doctor if your condition does not get better or if||
3095|092|H|it gets worse.||
3095|093|B|||
3095|094|S|SIDE EFFECTS:  See also Warning section.||
3095|095|S|   Nausea, drowsiness, dizziness, trouble sleeping, loss of||
3095|096|S|appetite, weakness, dry mouth, sweating, blurred vision, and||
3095|097|S|yawning may occur. If any of these effects last or get worse,||
3095|098|S|tell your doctor or pharmacist promptly.||
3095|099|S|   Remember that this medication has been prescribed because your||
3095|100|S|doctor has judged that the benefit to you is greater than the||
3095|101|S|risk of side effects. Many people using this medication do not||
3095|102|S|have serious side effects.||
3095|103|S|   Tell your doctor right away if you have any serious side||
3095|104|S|effects, including: shaking (tremor), restlessness, inability to||
3095|105|S|keep still, decreased interest in sex, changes in sexual ability,||
3095|106|S|numbness/tingling, easy bleeding/bruising, fast/irregular||
3095|107|S|heartbeat, muscle weakness/spasm, seizures.||
3095|108|S|   Get medical help right away if you have any very serious side||
3095|109|S|effects, including: black stools, vomit that looks like coffee||
3095|110|S|grounds, eye pain/swelling/redness, widened pupils, vision||
3095|111|S|changes (such as seeing rainbows around lights at night).||
3095|112|S|   This medication may increase serotonin and rarely cause a very||
3095|113|S|serious condition called serotonin syndrome/toxicity. The risk||
3095|114|S|increases if you are also taking other drugs that increase||
3095|115|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
3095|116|S|take (see Drug Interactions section). Get medical help right away||
3095|117|S|if you develop some of the following symptoms: fast heartbeat,||
3095|118|S|hallucinations, loss of coordination, severe dizziness, severe||
3095|119|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
3095|120|S|unusual agitation/restlessness.||
3095|121|S|   Rarely, males may have a painful or prolonged erection lasting||
3095|122|S|4 or more hours. If this occurs, stop using this drug and get||
3095|123|S|medical help right away, or permanent problems could occur.||
3095|124|S|   A very serious allergic reaction to this drug is rare.||
3095|125|S|However, get medical help right away if you notice any symptoms||
3095|126|S|of a serious allergic reaction, including: rash, itching/swelling||
3095|127|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3095|128|S|breathing.||
3095|129|S|   This is not a complete list of possible side effects. If you||
3095|130|S|notice other effects not listed above, contact your doctor or||
3095|131|S|pharmacist.||
3095|132|S|   In the US -||
3095|133|S|   Call your doctor for medical advice about side effects. You||
3095|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3095|135|S|www.fda.gov/medwatch.||
3095|136|S|   In Canada - Call your doctor for medical advice about side||
3095|137|S|effects. You may report side effects to Health Canada at||
3095|138|S|1-866-234-2345.||
3095|139|B|||
3095|140|P|PRECAUTIONS:  Before taking paroxetine, tell your doctor or||
3095|141|P|pharmacist if you are allergic to it; or if you have any other||
3095|142|P|allergies. This product may contain inactive ingredients, which||
3095|143|P|can cause allergic reactions or other problems. Talk to your||
3095|144|P|pharmacist for more details.||
3095|145|P|   Before using this medication, tell your doctor or pharmacist||
3095|146|P|your medical history, especially of: personal or family history||
3095|147|P|of bipolar/manic-depressive disorder, personal or family history||
3095|148|P|of suicide attempts, liver problems, kidney problems, seizures,||
3095|149|P|low sodium in the blood, bleeding problems, personal or family||
3095|150|P|history of glaucoma (angle-closure type).||
3095|151|P|   This drug may make you dizzy or drowsy or blur your vision.||
3095|152|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3095|153|P|drowsy. Do not drive, use machinery, or do anything that needs||
3095|154|P|alertness or clear vision until you can do it safely. Avoid||
3095|155|P|alcoholic beverages. Talk to your doctor if you are using||
3095|156|P|marijuana (cannabis).||
3095|157|P|   Before having surgery, tell your doctor or dentist about all||
3095|158|P|the products you use (including prescription drugs,||
3095|159|P|nonprescription drugs, and herbal products).||
3095|160|P|   Older adults may be more sensitive to the side effects of this||
3095|161|P|drug, especially bleeding or loss of coordination. Older adults||
3095|162|P|may also be more likely to develop a type of salt imbalance||
3095|163|P|(hyponatremia), especially if they are also taking "water pills"||
3095|164|P|(diuretics). Loss of coordination can increase the risk of||
3095|165|P|falling.||
3095|166|P|   Children may be more sensitive to the side effects of this||
3095|167|P|drug, especially loss of appetite and weight loss. Monitor weight||
3095|168|P|and height in children who are taking this drug.||
3095|169|P|   This medication is not recommended for use during pregnancy.||
3095|170|P|It may harm an unborn baby, and babies born to mothers who have||
3095|171|P|used it during the last 3 months of pregnancy may sometimes||
3095|172|P|develop withdrawal symptoms such as feeding/breathing||
3095|173|P|difficulties, seizures, muscle stiffness, or constant crying.||
3095|174|P|However, since untreated mental/mood problems (such as||
3095|175|P|depression, panic attack, obsessive-compulsive disorder, and||
3095|176|P|anxiety) can harm a pregnant woman and her unborn baby, do not||
3095|177|P|stop taking this medication unless directed by your doctor.||
3095|178|P|Instead, ask your doctor if a different medication would be right||
3095|179|P|for you. If you are planning pregnancy, become pregnant, or think||
3095|180|P|you may be pregnant, tell your doctor right away.||
3095|181|P|   This drug passes into breast milk. Consult your doctor before||
3095|182|P|breastfeeding.||
3095|183|B|||
3095|184|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3095|185|I|medications work or increase your risk for serious side effects.||
3095|186|I|This document does not contain all possible drug interactions.||
3095|187|I|Keep a list of all the products you use (including||
3095|188|I|prescription/nonprescription drugs and herbal products) and share||
3095|189|I|it with your doctor and pharmacist. Do not start, stop, or change||
3095|190|I|the dosage of any medicines without your doctor's approval.||
3095|191|I|   Some products that may interact with this drug are:||
3095|192|I|thioridazine, other drugs that can cause bleeding/bruising||
3095|193|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
3095|194|I|ibuprofen/naproxen, "blood thinners" such as||
3095|195|I|dabigatran/warfarin).||
3095|196|I|   Aspirin can increase the risk of bleeding when used with this||
3095|197|I|medication. However, if your doctor has told you to take low-dose||
3095|198|I|aspirin to prevent heart attack or stroke (usually 81-162||
3095|199|I|milligrams a day), you should keep taking the aspirin unless your||
3095|200|I|doctor tells you not to. Ask your doctor or pharmacist for more||
3095|201|I|details.||
3095|202|I|   This medication can slow down the removal of other medications||
3095|203|I|from your body, which may affect how they work. Examples of||
3095|204|I|affected drugs include atomoxetine, phenothiazines, pimozide,||
3095|205|I|risperidone, tamoxifen, tetrabenazine, antiarrhythmics such as||
3095|206|I|propafenone/flecainide, TCA antidepressants such as||
3095|207|I|desipramine/amitriptyline, among others.||
3095|208|I|   Taking MAO inhibitors with this medication may cause a serious||
3095|209|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
3095|210|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
3095|211|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
3095|212|I|selegiline, tranylcypromine) during treatment with this||
3095|213|I|medication. Most MAO inhibitors should also not be taken for two||
3095|214|I|weeks before and after treatment with this medication. Ask your||
3095|215|I|doctor when to start or stop taking this medication.||
3095|216|I|   The risk of serotonin syndrome/toxicity increases if you are||
3095|217|I|also taking other drugs that increase serotonin. Examples include||
3095|218|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
3095|219|I|antidepressants (including other SSRIs such as||
3095|220|I|citalopram/fluoxetine, SNRIs such as duloxetine/venlafaxine),||
3095|221|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
3095|222|I|may be more likely when you start or increase the dose of these||
3095|223|I|drugs.||
3095|224|I|   Tell your doctor or pharmacist if you are taking other||
3095|225|I|products that cause drowsiness including alcohol, marijuana||
3095|226|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
3095|227|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
3095|228|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
3095|229|I|codeine).||
3095|230|I|   Check the labels on all your medicines (such as allergy or||
3095|231|I|cough-and-cold products) because they may contain ingredients||
3095|232|I|that cause drowsiness. Ask your pharmacist about using those||
3095|233|I|products safely.||
3095|234|I|   This medication may interfere with certain medical/lab tests||
3095|235|I|(such as brain scan for Parkinson's disease), possibly causing||
3095|236|I|false test results. Make sure lab personnel and all your doctors||
3095|237|I|know you use this drug.||
3095|238|B|||
3095|239|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3095|240|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3095|241|O|poison control center right away. US residents can call||
3095|242|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3095|243|O|Symptoms of overdose may include: irregular heartbeat, fainting,||
3095|244|O|severe dizziness, seizures.||
3095|245|B|||
3095|246|N|NOTES:  Do not share this medication with others.||
3095|247|N|   Keep all medical and lab appointments.||
3095|248|B|||
3095|249|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3095|250|D|remember. If it is near the time of the next dose, skip the||
3095|251|D|missed dose. Take your next dose at the regular time. Do not||
3095|252|D|double the dose to catch up.||
3095|253|B|||
3095|254|R|STORAGE:  Store at room temperature away from light and moisture.||
3095|255|R|Do not store in the bathroom. Keep all medications away from||
3095|256|R|children and pets.||
3095|257|R|   Do not flush medications down the toilet or pour them into a||
3095|258|R|drain unless instructed to do so. Properly discard this product||
3095|259|R|when it is expired or no longer needed. Consult your pharmacist||
3095|260|R|or local waste disposal company.||
3095|261|B|||
3095|262|A|Information last revised February 2025.||
3095|263|A|Copyright(c) 2025 First Databank, Inc.||
3095|264|B|||
3105|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3105|002|Z|does NOT have all possible information about this product. This||
3105|003|Z|information does not assure that this product is safe, effective,||
3105|004|Z|or appropriate for you. This information is not individual||
3105|005|Z|medical advice and does not substitute for the advice of your||
3105|006|Z|health care professional. Always ask your health care||
3105|007|Z|professional for complete information about this product and your||
3105|008|Z|specific health needs.||
3105|009|B|||
3105|010|T|METHOCARBAMOL/ACETAMINOPHEN - ORAL||
3105|011|F|(METH-oh-KAR-ba-mol/a-SEET-a-MIN-oh-fen)||
3105|012|B|||
3105|013|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
3105|014|W|too much acetaminophen may cause serious (possibly fatal) liver||
3105|015|W|disease. Adults should not take more than 4000 milligrams (4||
3105|016|W|grams) of acetaminophen a day. People with liver problems and||
3105|017|W|children should take less acetaminophen. Ask your doctor or||
3105|018|W|pharmacist how much acetaminophen is safe to take.||
3105|019|W|   Do not use with any other drug containing acetaminophen||
3105|020|W|without asking your doctor or pharmacist first. Acetaminophen is||
3105|021|W|in many nonprescription and prescription medications (such as||
3105|022|W|pain/fever drugs or cough-and-cold products). Check the labels on||
3105|023|W|all your medicines to see if they contain acetaminophen, and ask||
3105|024|W|your pharmacist if you are unsure.||
3105|025|W|   Get medical help right away if you take too much acetaminophen||
3105|026|W|(overdose), even if you feel well. Overdose symptoms may include||
3105|027|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
3105|028|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
3105|029|W|   Daily alcohol use, especially when combined with||
3105|030|W|acetaminophen, may damage your liver. Avoid alcohol.||
3105|031|B|||
3105|032|U|USES:  This product is used to treat muscle spasms/pain.||
3105|033|U|Methocarbamol helps to relax the muscles. Acetaminophen helps to||
3105|034|U|decrease the pain.||
3105|035|B|||
3105|036|H|HOW TO USE:  See also Warning section.||
3105|037|H|   Take this medication by mouth with or without food as directed||
3105|038|H|by your doctor. Do not increase your dose or use this drug more||
3105|039|H|often or for longer than prescribed. Your condition will not||
3105|040|H|improve any faster, and your risk of side effects will increase.||
3105|041|H|   The dosage is based on your medical condition and response to||
3105|042|H|treatment.||
3105|043|H|   Pain medications work best if they are used as the first signs||
3105|044|H|of pain occur. If you wait until the symptoms have worsened, the||
3105|045|H|medication may not work as well.||
3105|046|H|   Tell your doctor if your condition lasts or gets worse.||
3105|047|B|||
3105|048|S|SIDE EFFECTS:  See also Warning section.||
3105|049|S|   Drowsiness, dizziness, lightheadedness, stomach upset,||
3105|050|S|nausea/vomiting, or blurred vision may occur. If any of these||
3105|051|S|effects last or get worse, tell your doctor or pharmacist||
3105|052|S|promptly.||
3105|053|S|   Remember that this medication has been prescribed because your||
3105|054|S|doctor has judged that the benefit to you is greater than the||
3105|055|S|risk of side effects. Many people using this medication do not||
3105|056|S|have serious side effects.||
3105|057|S|   Tell your doctor right away if you have any serious side||
3105|058|S|effects, including: fainting, slow heartbeat, mental/mood changes||
3105|059|S|(such as confusion, forgetfulness).||
3105|060|S|   A very serious allergic reaction to this drug is rare.||
3105|061|S|However, get medical help right away if you notice any symptoms||
3105|062|S|of a serious allergic reaction, including: rash, itching/swelling||
3105|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3105|064|S|breathing.||
3105|065|S|   This is not a complete list of possible side effects. If you||
3105|066|S|notice other effects not listed above, contact your doctor or||
3105|067|S|pharmacist.||
3105|068|S|   In the US -||
3105|069|S|   Call your doctor for medical advice about side effects. You||
3105|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3105|071|S|www.fda.gov/medwatch.||
3105|072|S|   In Canada - Call your doctor for medical advice about side||
3105|073|S|effects. You may report side effects to Health Canada at||
3105|074|S|1-866-234-2345.||
3105|075|B|||
3105|076|P|PRECAUTIONS:  See also Warning section.||
3105|077|P|   Before taking this medication, tell your doctor or pharmacist||
3105|078|P|if you are allergic to methocarbamol or acetaminophen; or if you||
3105|079|P|have any other allergies. This product may contain inactive||
3105|080|P|ingredients, which can cause allergic reactions or other||
3105|081|P|problems. Talk to your pharmacist for more details.||
3105|082|P|   Before using this medication, tell your doctor or pharmacist||
3105|083|P|your medical history, especially of: liver disease, alcohol use.||
3105|084|P|   This drug may make you dizzy or drowsy or blur your vision.||
3105|085|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3105|086|P|drowsy. Do not drive, use machinery, or do anything that needs||
3105|087|P|alertness or clear vision until you can do it safely. Avoid||
3105|088|P|alcoholic beverages. Talk to your doctor if you are using||
3105|089|P|marijuana (cannabis). Alcohol may also increase the risk of||
3105|090|P|serious liver problems.||
3105|091|P|   Before having surgery, tell your doctor or dentist about all||
3105|092|P|the products you use (including prescription drugs,||
3105|093|P|nonprescription drugs, and herbal products).||
3105|094|P|   Older adults may be more sensitive to the side effects of this||
3105|095|P|drug, especially confusion, dizziness, or drowsiness. These side||
3105|096|P|effects can increase the risk of falling.||
3105|097|P|   During pregnancy, this medication should be used only when||
3105|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
3105|099|P|   Acetaminophen passes into breast milk. It is unknown if||
3105|100|P|methocarbamol passes into breast milk. Consult your doctor before||
3105|101|P|breastfeeding.||
3105|102|B|||
3105|103|I|DRUG INTERACTIONS:  See also Warning section.||
3105|104|I|   Drug interactions may change how your medications work or||
3105|105|I|increase your risk for serious side effects. This document does||
3105|106|I|not contain all possible drug interactions. Keep a list of all||
3105|107|I|the products you use (including prescription/nonprescription||
3105|108|I|drugs and herbal products) and share it with your doctor and||
3105|109|I|pharmacist. Do not start, stop, or change the dosage of any||
3105|110|I|medicines without your doctor's approval.||
3105|111|I|   Some products that may interact with this drug are:||
3105|112|I|ketoconazole, levoketoconazole.||
3105|113|I|   Tell your doctor or pharmacist if you are taking other||
3105|114|I|products that cause drowsiness such as opioid pain or cough||
3105|115|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3105|116|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3105|117|I|lorazepam, zolpidem), other muscle relaxants (such as||
3105|118|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
3105|119|I|cetirizine, diphenhydramine).||
3105|120|I|   Check the labels on all your medicines (such as allergy or||
3105|121|I|cough-and-cold products) because they may contain ingredients||
3105|122|I|that cause drowsiness. Ask your pharmacist about using those||
3105|123|I|products safely.||
3105|124|I|   This medication may interfere with certain lab tests (such as||
3105|125|I|VMA or 5-HIAA urine screening test), possibly causing false test||
3105|126|I|results. Make sure lab personnel and all your doctors know you||
3105|127|I|use this drug.||
3105|128|B|||
3105|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3105|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3105|131|O|poison control center right away. US residents can call||
3105|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3105|133|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
3105|134|O|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
3105|135|O|pain, extreme tiredness, seizures, yellowing eyes/skin, dark||
3105|136|O|urine.||
3105|137|B|||
3105|138|N|NOTES:  Do not share this medication with others.||
3105|139|N|   This medication has been prescribed for your current condition||
3105|140|N|only. Do not use it later for another condition unless your||
3105|141|N|doctor directs you to do so. A different medication may be||
3105|142|N|necessary in that case.||
3105|143|B|||
3105|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3105|145|D|remember. If it is near the time of the next dose, skip the||
3105|146|D|missed dose. Take your next dose at the regular time. Do not||
3105|147|D|double the dose to catch up.||
3105|148|B|||
3105|149|R|STORAGE:  Store at room temperature away from light and moisture.||
3105|150|R|Do not store in the bathroom. Keep all medications away from||
3105|151|R|children and pets.||
3105|152|R|   Do not flush medications down the toilet or pour them into a||
3105|153|R|drain unless instructed to do so. Properly discard this product||
3105|154|R|when it is expired or no longer needed. Consult your pharmacist||
3105|155|R|or local waste disposal company.||
3105|156|B|||
3105|157|A|Information last revised May 2024.||
3105|158|A|Copyright(c) 2025 First Databank, Inc.||
3105|159|B|||
3108|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3108|002|Z|does NOT have all possible information about this product. This||
3108|003|Z|information does not assure that this product is safe, effective,||
3108|004|Z|or appropriate for you. This information is not individual||
3108|005|Z|medical advice and does not substitute for the advice of your||
3108|006|Z|health care professional. Always ask your health care||
3108|007|Z|professional for complete information about this product and your||
3108|008|Z|specific health needs.||
3108|009|B|||
3108|010|T|CYCLOSPORINE MICROEMULSION SOLUTION - ORAL||
3108|011|F|(SYE-kloe-SPOR-in MY-crow-ee-MULL-shun)||
3108|012|B|||
3108|013|C|COMMON BRAND NAME(S): Gengraf, Neoral||
3108|014|B|||
3108|015|W|WARNING:  Cyclosporine lowers your ability to fight infections.||
3108|016|W|This may make you more likely to get a serious (rarely fatal)||
3108|017|W|infection or make any infection you have worse. This effect may||
3108|018|W|also increase your risk of getting certain types of cancer (such||
3108|019|W|as skin cancer, lymphoma). Tell your doctor right away if you||
3108|020|W|have any signs of infection or cancer such as sore throat that||
3108|021|W|doesn't go away, fever, chills, burning/frequent urination,||
3108|022|W|unusual skin changes, change in appearance or size of moles,||
3108|023|W|unusual weight loss, swollen lymph nodes, unusual lumps, night||
3108|024|W|sweats.||
3108|025|W|   Cyclosporine can also cause high blood pressure and kidney||
3108|026|W|problems. The risk of both problems increases with higher doses||
3108|027|W|and longer treatment with this drug. Your doctor will monitor||
3108|028|W|your blood pressure and kidney function while you take this||
3108|029|W|medication.||
3108|030|W|   Psoriasis patients who have had certain previous treatments||
3108|031|W|(such as coal tar, methotrexate, radiation treatment, light||
3108|032|W|treatment with PUVA/UVB) are at increased risk to develop skin||
3108|033|W|cancer. Talk to your doctor of the risks and benefits of this||
3108|034|W|medication.||
3108|035|W|   Different brands of this medication may deliver different||
3108|036|W|amounts of medication. Do not switch brands of cyclosporine||
3108|037|W|without your doctor's permission and directions.||
3108|038|B|||
3108|039|U|USES:  Cyclosporine is used to prevent organ rejection in people||
3108|040|U|who have received a liver, kidney, or heart transplant. It is||
3108|041|U|usually taken along with other medications to allow your new||
3108|042|U|organ to function normally. Cyclosporine is also used to treat||
3108|043|U|severe cases of rheumatoid arthritis and plaque psoriasis. In||
3108|044|U|these conditions, the body's defense system (immune system)||
3108|045|U|attacks healthy tissues. Cyclosporine belongs to a class of drugs||
3108|046|U|known as immunosuppressants. It works by weakening the immune||
3108|047|U|system to help your body accept the new organ as if it were your||
3108|048|U|own (in the case of an organ transplant) and to prevent further||
3108|049|U|damage to your joints (in the case of rheumatoid arthritis) or||
3108|050|U|skin (in the case of psoriasis).||
3108|051|B|||
3108|052|V|OTHER USES:  This section contains uses of this drug that are not||
3108|053|V|listed in the approved professional labeling for the drug but||
3108|054|V|that may be prescribed by your health care professional. Use this||
3108|055|V|drug for a condition that is listed in this section only if it||
3108|056|V|has been so prescribed by your health care professional.||
3108|057|V|   This drug may also be used to reduce the risk of rejection in||
3108|058|V|other types of organ transplants (such as cornea, pancreas) or||
3108|059|V|bone marrow transplant. It may also be used for other conditions||
3108|060|V|that are affected by the body's immune system (such as Crohn's||
3108|061|V|disease).||
3108|062|B|||
3108|063|H|HOW TO USE:  Take this medication by mouth as directed by your||
3108|064|H|doctor, usually twice daily. You may take this medication with or||
3108|065|H|without food, but it is important to choose one way and take this||
3108|066|H|medication the same way with every dose.||
3108|067|H|   The dosage is based on your weight, medical condition, lab||
3108|068|H|tests, and response to treatment.||
3108|069|H|   Carefully measure the dose using the medicine syringe||
3108|070|H|provided. Do not use a household spoon because you may not get||
3108|071|H|the correct dose. To help improve the taste, you should mix the||
3108|072|H|measured dose with a glass of orange or apple juice that is at||
3108|073|H|room temperature. Do not switch juices often. Do not mix this||
3108|074|H|medication with milk since it may cause it to have a bad taste.||
3108|075|H|Make sure to use a glass cup and not a plastic cup. Drink all of||
3108|076|H|the mixture right away. Do not prepare a supply in advance. To||
3108|077|H|make sure you have taken all of the medication, rinse the glass||
3108|078|H|with more juice, then mix and drink. Consult your pharmacist if||
3108|079|H|you have any questions.||
3108|080|H|   Dry the outside of the syringe after use. Do not rinse it with||
3108|081|H|water. If the syringe must be cleaned, make sure that it is||
3108|082|H|completely dry before using it again.||
3108|083|H|   Avoid eating grapefruit or drinking grapefruit juice while||
3108|084|H|using this medication unless your doctor or pharmacist says you||
3108|085|H|may do so safely. Grapefruit can increase the chance of side||
3108|086|H|effects with this medicine. Ask your doctor or pharmacist for||
3108|087|H|more details.||
3108|088|H|   Use this medication regularly to get the most benefit from it.||
3108|089|H|To help you remember, take it at the same times each day.||
3108|090|H|   It may take up to 4 months before you get the full benefit of||
3108|091|H|this drug for the treatment of rheumatoid arthritis and||
3108|092|H|psoriasis.||
3108|093|H|   Tell your doctor if your condition does not get better (in 4||
3108|094|H|to 8 weeks for arthritis and in 2 to 4 weeks for psoriasis) or if||
3108|095|H|it gets worse.||
3108|096|B|||
3108|097|S|SIDE EFFECTS:  See also Warning section.||
3108|098|S|   Shaking, headache, dizziness, unusual growth of body hair,||
3108|099|S|nausea/vomiting, diarrhea, stomach upset, or flushing may occur.||
3108|100|S|If any of these effects last or get worse, tell your doctor or||
3108|101|S|pharmacist promptly.||
3108|102|S|   Unusual growth and swelling of the gums may occur. Brush your||
3108|103|S|teeth and floss daily to reduce this problem. See your dentist||
3108|104|S|regularly.||
3108|105|S|   Remember that this medication has been prescribed because your||
3108|106|S|doctor has judged that the benefit to you is greater than the||
3108|107|S|risk of side effects. Many people using this medication do not||
3108|108|S|have serious side effects.||
3108|109|S|   This medication may raise your blood pressure. Check your||
3108|110|S|blood pressure regularly and tell your doctor if the results are||
3108|111|S|high. Your doctor may control your blood pressure with||
3108|112|S|medication.||
3108|113|S|   Tell your doctor right away if you have any serious side||
3108|114|S|effects, including: signs of kidney problems (such as a change in||
3108|115|S|the amount of urine), signs of liver disease (such as||
3108|116|S|nausea/vomiting that doesn't stop, dark urine, yellowing||
3108|117|S|eyes/skin, stomach/abdominal pain), easy bruising/bleeding,||
3108|118|S|unusual tiredness, muscle weakness/spasms, slow/irregular||
3108|119|S|heartbeat, numb/tingling skin, severe leg pain.||
3108|120|S|   Get medical help right away if you have any very serious side||
3108|121|S|effects, including: mental/mood changes (such as confusion,||
3108|122|S|difficulty concentrating), vision changes, problems with speech,||
3108|123|S|clumsiness, loss of coordination, weakness on one side of the||
3108|124|S|body, seizures, chest pain.||
3108|125|S|   A very serious allergic reaction to this drug is rare.||
3108|126|S|However, get medical help right away if you notice any symptoms||
3108|127|S|of a serious allergic reaction, including: rash, itching/swelling||
3108|128|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3108|129|S|breathing.||
3108|130|S|   This is not a complete list of possible side effects. If you||
3108|131|S|notice other effects not listed above, contact your doctor or||
3108|132|S|pharmacist.||
3108|133|S|   In the US -||
3108|134|S|   Call your doctor for medical advice about side effects. You||
3108|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3108|136|S|www.fda.gov/medwatch.||
3108|137|S|   In Canada - Call your doctor for medical advice about side||
3108|138|S|effects. You may report side effects to Health Canada at||
3108|139|S|1-866-234-2345.||
3108|140|B|||
3108|141|P|PRECAUTIONS:  Before taking cyclosporine, tell your doctor or||
3108|142|P|pharmacist if you are allergic to it; or if you have any other||
3108|143|P|allergies. This product may contain inactive ingredients, which||
3108|144|P|can cause allergic reactions or other problems. Talk to your||
3108|145|P|pharmacist for more details.||
3108|146|P|   Before using this medication, tell your doctor or pharmacist||
3108|147|P|your medical history, especially of: kidney disease, liver||
3108|148|P|disease, high blood pressure, cancer, skin lesions of unknown||
3108|149|P|cause, radiation treatment (including light treatment with PUVA||
3108|150|P|or UVB), mineral imbalance (such as low level of magnesium or||
3108|151|P|high level of potassium), recent/current infections, high||
3108|152|P|cholesterol/triglycerides levels.||
3108|153|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3108|154|P|can make you more dizzy. Do not drive, use machinery, or do||
3108|155|P|anything that needs alertness until you can do it safely. Limit||
3108|156|P|alcoholic beverages. Talk to your doctor if you are using||
3108|157|P|marijuana (cannabis).||
3108|158|P|   This medication may contain alcohol. Caution is advised if you||
3108|159|P|are pregnant or breastfeeding or have liver disease, alcohol||
3108|160|P|dependence, or any other condition that requires you to||
3108|161|P|limit/avoid alcohol in your diet. Ask your doctor or pharmacist||
3108|162|P|about using this product safely.||
3108|163|P|   Cyclosporine can make you more likely to get infections or may||
3108|164|P|make current infections worse. Stay away from anyone who has an||
3108|165|P|infection that may easily spread (such as chickenpox, COVID-19,||
3108|166|P|measles, flu). Talk to your doctor if you have been exposed to an||
3108|167|P|infection or for more details.||
3108|168|P|   Tell your health care professional that you are using||
3108|169|P|cyclosporine before having any immunizations/vaccinations. Avoid||
3108|170|P|contact with people who have recently received live vaccines||
3108|171|P|(such as flu vaccine inhaled through the nose).||
3108|172|P|   This medication may increase your risk of developing skin||
3108|173|P|cancer. Limit your time in the sun. Avoid tanning booths and||
3108|174|P|sunlamps. Use sunscreen and wear protective clothing when||
3108|175|P|outdoors. Your doctor may direct you to avoid phototherapy while||
3108|176|P|you use this product. Ask your doctor for details.||
3108|177|P|   This product may increase your potassium levels. Before using||
3108|178|P|potassium supplements or salt substitutes that contain potassium,||
3108|179|P|consult your doctor or pharmacist.||
3108|180|P|   Before having surgery, tell your doctor or dentist about all||
3108|181|P|the products you use (including prescription drugs,||
3108|182|P|nonprescription drugs, and herbal products).||
3108|183|P|   Older adults may be at greater risk for kidney problems or||
3108|184|P|high blood pressure while using this drug.||
3108|185|P|   During pregnancy, this medication should be used only when||
3108|186|P|clearly needed. It may harm an unborn baby or cause other||
3108|187|P|problems with the baby such as being born too early (premature)||
3108|188|P|or having low birth weight. Discuss the risks and benefits with||
3108|189|P|your doctor.||
3108|190|P|   This medication passes into breast milk. Consult your doctor||
3108|191|P|before breastfeeding.||
3108|192|B|||
3108|193|I|DRUG INTERACTIONS:  See also How to Use section.||
3108|194|I|   Drug interactions may change how your medications work or||
3108|195|I|increase your risk for serious side effects. This document does||
3108|196|I|not contain all possible drug interactions. Keep a list of all||
3108|197|I|the products you use (including prescription/nonprescription||
3108|198|I|drugs and herbal products) and share it with your doctor and||
3108|199|I|pharmacist. Do not start, stop, or change the dosage of any||
3108|200|I|medicines without your doctor's approval.||
3108|201|I|   Some products that may interact with this drug include: coal||
3108|202|I|tar, orlistat, other drugs that weaken the immune system/increase||
3108|203|I|the risk of infection (such as natalizumab, rituximab,||
3108|204|I|tofacitinib), drugs that may increase potassium levels (such as||
3108|205|I|potassium supplements, certain diuretics/"water pills" including||
3108|206|I|amiloride, spironolactone), tacrolimus.||
3108|207|I|   Other medications can affect the removal of cyclosporine from||
3108|208|I|your body, which may affect how cyclosporine works. Examples||
3108|209|I|include bosentan, mifepristone, St. John's wort, ritonavir, among||
3108|210|I|others.||
3108|211|I|   This medication can slow down the removal of other medications||
3108|212|I|from your body, which may affect how they work. Examples of||
3108|213|I|affected drugs include aliskiren, dabigatran, dronedarone,||
3108|214|I|elagolix, resmetirom, certain statins (such as pitavastatin,||
3108|215|I|simvastatin), voxilaprevir, among others.||
3108|216|B|||
3108|217|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3108|218|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3108|219|O|poison control center right away. US residents can call||
3108|220|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3108|221|B|||
3108|222|N|NOTES:  Do not share this medication with others.||
3108|223|N|   Lab and/or medical tests (such as kidney/liver function, blood||
3108|224|N|pressure, blood mineral levels, cyclosporine blood levels,||
3108|225|N|complete blood count, uric acid levels, lipid levels, skin exam)||
3108|226|N|should be done while you are taking this medication. Keep all||
3108|227|N|medical and lab appointments. Consult your doctor for more||
3108|228|N|details.||
3108|229|N|   If you have had an organ transplant, it is recommended that||
3108|230|N|you attend a transplant education class or support group. Learn||
3108|231|N|the symptoms of organ rejection such as a feeling of being ill,||
3108|232|N|fever, pain around the transplanted organ, and signs of a failing||
3108|233|N|transplanted organ (a decrease in the amount of urine with kidney||
3108|234|N|transplant, yellowing of the skin/eyes with liver transplant,||
3108|235|N|shortness of breath/inability to exercise with heart transplant).||
3108|236|N|Get medical help right away if these symptoms of rejection occur.||
3108|237|B|||
3108|238|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3108|239|D|remember. If it is near the time of the next dose, skip the||
3108|240|D|missed dose. Take your next dose at the regular time. Do not||
3108|241|D|double the dose to catch up.||
3108|242|B|||
3108|243|R|STORAGE:  Store in the original bottle at room temperature. Do||
3108|244|R|not refrigerate. Once the bottle is opened, this medication||
3108|245|R|expires after 2 months. If stored below 68 degrees F (20 degrees||
3108|246|R|C), the solution may thicken and particles may form. This does||
3108|247|R|not affect the medication. If this occurs, store the solution at||
3108|248|R|room temperature to allow it to warm up. Keep all medications||
3108|249|R|away from children and pets.||
3108|250|R|   Do not flush medications down the toilet or pour them into a||
3108|251|R|drain unless instructed to do so. Properly discard this product||
3108|252|R|when it is expired or no longer needed. Consult your pharmacist||
3108|253|R|or local waste disposal company.||
3108|254|B|||
3108|255|M|MEDICAL ALERT:  Your condition can cause complications in a||
3108|256|M|medical emergency. For information about enrolling in MedicAlert,||
3108|257|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3108|258|B|||
3108|259|A|Information last revised May 2025.||
3108|260|A|Copyright(c) 2025 First Databank, Inc.||
3108|261|B|||
3109|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3109|002|Z|does NOT have all possible information about this product. This||
3109|003|Z|information does not assure that this product is safe, effective,||
3109|004|Z|or appropriate for you. This information is not individual||
3109|005|Z|medical advice and does not substitute for the advice of your||
3109|006|Z|health care professional. Always ask your health care||
3109|007|Z|professional for complete information about this product and your||
3109|008|Z|specific health needs.||
3109|009|B|||
3109|010|T|SENNOSIDES/DOCUSATE - ORAL||
3109|011|F|(SEN-oh-sides/DOCK-you-sate)||
3109|012|B|||
3109|013|C|COMMON BRAND NAME(S): Senna S, Senokot-S||
3109|014|B|||
3109|015|U|USES:  This product is used to treat constipation. It contains 2||
3109|016|U|medications: sennosides and docusate. Sennosides are known as||
3109|017|U|stimulant laxatives. They work by keeping water in the||
3109|018|U|intestines, which helps to cause movement of the intestines.||
3109|019|U|Docusate is known as a stool softener. It helps increase the||
3109|020|U|amount of water in the stool, making it softer and easier to||
3109|021|U|pass.||
3109|022|B|||
3109|023|H|HOW TO USE:  Take this medication by mouth with a full glass of||
3109|024|H|water (8 ounces/240 milliliters) as directed by your doctor. If||
3109|025|H|you are self-treating, follow all directions on the product||
3109|026|H|package. If you have any questions, ask your doctor or||
3109|027|H|pharmacist.||
3109|028|H|   Dosage is based on your age, medical condition, and response||
3109|029|H|to treatment. Do not increase your dose or take this drug more||
3109|030|H|often than directed. Do not take this medication for more than 7||
3109|031|H|days unless directed by your doctor. Serious side effects may||
3109|032|H|occur with overuse of this medication (see also Side Effects||
3109|033|H|section).||
3109|034|H|   It may take 6 to 12 hours before this medication causes a||
3109|035|H|bowel movement. Tell your doctor if your condition lasts or gets||
3109|036|H|worse, or if bleeding from the rectum occurs. If you think you||
3109|037|H|may have a serious medical problem, get medical help right away.||
3109|038|B|||
3109|039|S|SIDE EFFECTS:  Stomach/abdominal pain or cramping, nausea,||
3109|040|S|diarrhea, or weakness may occur. If any of these effects last or||
3109|041|S|get worse, tell your doctor or pharmacist promptly.||
3109|042|S|   This medication may cause your urine to turn reddish-brown.||
3109|043|S|This effect is harmless and will disappear when the medication is||
3109|044|S|stopped.||
3109|045|S|   If your doctor has directed you to use this medication,||
3109|046|S|remember that your doctor has judged that the benefit to you is||
3109|047|S|greater than the risk of side effects. Many people using this||
3109|048|S|medication do not have serious side effects.||
3109|049|S|   Tell your doctor right away if you have any serious side||
3109|050|S|effects, including: nausea/vomiting/diarrhea that doesn't stop,||
3109|051|S|muscle cramps/weakness, irregular heartbeat, dizziness, decreased||
3109|052|S|urination, mental/mood changes (such as confusion).||
3109|053|S|   A very serious allergic reaction to this drug is rare.||
3109|054|S|However, get medical help right away if you notice any symptoms||
3109|055|S|of a serious allergic reaction, including: rash, itching/swelling||
3109|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3109|057|S|breathing.||
3109|058|S|   This is not a complete list of possible side effects. If you||
3109|059|S|notice other effects not listed above, contact your doctor or||
3109|060|S|pharmacist.||
3109|061|S|   In the US -||
3109|062|S|   Call your doctor for medical advice about side effects. You||
3109|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3109|064|S|www.fda.gov/medwatch.||
3109|065|S|   In Canada - Call your doctor for medical advice about side||
3109|066|S|effects. You may report side effects to Health Canada at||
3109|067|S|1-866-234-2345.||
3109|068|B|||
3109|069|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
3109|070|P|pharmacist if you are allergic to senna, sennosides, or docusate;||
3109|071|P|or if you have any other allergies. This product may contain||
3109|072|P|inactive ingredients, which can cause allergic reactions or other||
3109|073|P|problems. Talk to your pharmacist for more details.||
3109|074|P|   Before using this medication, tell your doctor or pharmacist||
3109|075|P|your medical history, especially of: appendicitis or symptoms of||
3109|076|P|appendicitis (such as nausea/vomiting, sudden or unexplained||
3109|077|P|stomach/abdominal pain), a sudden change in bowel habits that||
3109|078|P|lasts for longer than 2 weeks, bleeding from the rectum,||
3109|079|P|intestinal blockage.||
3109|080|P|   Before having surgery, tell your doctor or dentist about all||
3109|081|P|the products you use (including prescription drugs,||
3109|082|P|nonprescription drugs, and herbal products).||
3109|083|P|   Tell your doctor if you are pregnant before using this||
3109|084|P|medication. Using it for long periods during pregnancy is not||
3109|085|P|recommended. Consult your doctor for more details.||
3109|086|P|   This medication passes into breast milk, but is unlikely to||
3109|087|P|harm a nursing infant. Consult your doctor before breastfeeding.||
3109|088|B|||
3109|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3109|090|I|medications work or increase your risk for serious side effects.||
3109|091|I|This document does not contain all possible drug interactions.||
3109|092|I|Keep a list of all the products you use (including||
3109|093|I|prescription/nonprescription drugs and herbal products) and share||
3109|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
3109|095|I|the dosage of any medicines without your doctor's approval.||
3109|096|I|   A product that may interact with this drug is: mineral oil.||
3109|097|B|||
3109|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3109|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3109|100|O|poison control center right away. US residents can call||
3109|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3109|102|O|Symptoms of overdose may include: nausea/vomiting/diarrhea that||
3109|103|O|doesn't stop, severe stomach/abdominal pain or cramping.||
3109|104|B|||
3109|105|N|NOTES:  Keep all medical and lab appointments.||
3109|106|N|   Lifestyle changes that may prevent or relieve constipation||
3109|107|N|include exercising, drinking enough water, and eating a proper||
3109|108|N|diet with fiber-rich foods such as bran, fresh fruits/vegetables.||
3109|109|N|Talk to your doctor or pharmacist about lifestyle changes that||
3109|110|N|might benefit you.||
3109|111|B|||
3109|112|D|MISSED DOSE:  If your doctor has directed you to take this||
3109|113|D|medication on a regular schedule and you miss a dose, take it as||
3109|114|D|soon as you remember. If it is near the time of the next dose,||
3109|115|D|skip the missed dose. Take your next dose at the regular time. Do||
3109|116|D|not double the dose to catch up.||
3109|117|B|||
3109|118|R|STORAGE:  Different brands of this medication have different||
3109|119|R|storage needs. Check the product package for instructions on how||
3109|120|R|to store your brand, or ask your pharmacist. Keep all medications||
3109|121|R|away from children and pets.||
3109|122|R|   Do not flush medications down the toilet or pour them into a||
3109|123|R|drain unless instructed to do so. Properly discard this product||
3109|124|R|when it is expired or no longer needed. Consult your pharmacist||
3109|125|R|or local waste disposal company.||
3109|126|B|||
3109|127|A|Information last revised May 2024.||
3109|128|A|Copyright(c) 2025 First Databank, Inc.||
3109|129|B|||
3115|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3115|002|Z|does NOT have all possible information about this product. This||
3115|003|Z|information does not assure that this product is safe, effective,||
3115|004|Z|or appropriate for you. This information is not individual||
3115|005|Z|medical advice and does not substitute for the advice of your||
3115|006|Z|health care professional. Always ask your health care||
3115|007|Z|professional for complete information about this product and your||
3115|008|Z|specific health needs.||
3115|009|B|||
3115|010|T|ETONOGESTREL/ETHINYL ESTRADIOL RING - VAGINAL||
3115|011|F|(e-TOE-noe-JES-trel / ETH-i-nil ES-tra-DYE-ol)||
3115|012|B|||
3115|013|C|COMMON BRAND NAME(S): Nuvaring||
3115|014|B|||
3115|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
3115|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
3115|017|W|stroke, heart attack, blood clots, and high blood pressure from||
3115|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
3115|019|W|of these serious problems increases with age and with the number||
3115|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
3115|021|B|||
3115|022|U|USES:  This product is a vaginal ring containing combination||
3115|023|U|hormone medication and is used to prevent pregnancy. It contains||
3115|024|U|2 hormones: a progestin (etonogestrel) and an estrogen (ethinyl||
3115|025|U|estradiol).||
3115|026|U|   This product does not protect against sexually transmitted||
3115|027|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
3115|028|U|an effective barrier method (latex or polyurethane condom/dental||
3115|029|U|dams) during sexual activity will help to decrease your risk of||
3115|030|U|infection.||
3115|031|B|||
3115|032|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
3115|033|H|your pharmacist before you start using this product and each time||
3115|034|H|you get a refill. The leaflet contains very important information||
3115|035|H|on how to properly use and dispose of the vaginal ring. If you||
3115|036|H|have any questions, ask your doctor or pharmacist.||
3115|037|H|   This product is for vaginal use only. Before use, wash and dry||
3115|038|H|your hands. Remove the ring from the reclosable foil pouch,||
3115|039|H|keeping the pouch for later disposal of the used ring. Fold the||
3115|040|H|ring in half and gently push it into your vagina as directed,||
3115|041|H|until it feels comfortable. Although some women may be aware of||
3115|042|H|the ring in the vagina, most women do not feel it once it is in||
3115|043|H|place; it will not interfere with sexual intercourse (though your||
3115|044|H|partner may be able to feel the ring). Unlike a diaphragm, the||
3115|045|H|ring's exact position in the vagina does not affect how well it||
3115|046|H|works. Once inserted, keep the ring in place for 3 weeks in a||
3115|047|H|row.||
3115|048|H|   If this is the first time you are using the ring, use a backup||
3115|049|H|form of non-hormonal birth control (such as condoms, spermicide)||
3115|050|H|for the first 7 days to prevent pregnancy until the ring has||
3115|051|H|enough time to work. Do not use a diaphragm, female condom, or||
3115|052|H|cervical cap for backup birth control since the ring may||
3115|053|H|interfere with proper placement. If you start using the ring on||
3115|054|H|the first day of your period, you do not need to use backup birth||
3115|055|H|control the first week.||
3115|056|H|   After using the ring for 3 weeks, remove it on the same day of||
3115|057|H|the week and about the same time that you placed it. Place the||
3115|058|H|used ring back into the foil pouch and discard in the trash. Do||
3115|059|H|not flush the used ring down a toilet. If you have pain/bleeding||
3115|060|H|when trying to remove the ring, or if you cannot remove it, tell||
3115|061|H|your doctor right away.||
3115|062|H|   Next, do not wear a ring for 1 week (7 days). You should have||
3115|063|H|your period within 2 to 3 days after the ring is removed. After 1||
3115|064|H|ring-free week, insert a new ring on the same day of the week||
3115|065|H|that you removed the old ring, whether or not you have your||
3115|066|H|period. If you do not get your period, consult your doctor. Do||
3115|067|H|not go longer than 7 days without a ring. Doing so will increase||
3115|068|H|your risk of pregnancy.||
3115|069|H|   Regularly check that the ring is in your vagina, such as||
3115|070|H|before and after sexual intercourse. The ring may accidentally||
3115|071|H|fall out during sexual intercourse, during a bowel movement, or||
3115|072|H|while removing a tampon. If this happens and the ring has been||
3115|073|H|out of your vagina for less than 3 hours, rinse it with cool to||
3115|074|H|lukewarm (not hot) water and re-insert the ring as soon as||
3115|075|H|possible. If the ring has been out longer than 3 hours, you could||
3115|076|H|become pregnant. Re-insert it or insert a new ring as directed||
3115|077|H|and use a backup form of non-hormonal birth control (such as||
3115|078|H|condoms, spermicide) for the next 7 days to prevent pregnancy. If||
3115|079|H|you are not sure how long the ring has been out of your vagina,||
3115|080|H|you may not be protected from pregnancy. Contact your doctor for||
3115|081|H|a pregnancy test before inserting a new ring and use a backup||
3115|082|H|form of non-hormonal birth control (such as condoms, spermicide)||
3115|083|H|for 7 days.||
3115|084|H|   If you have left the ring in place longer than directed, up to||
3115|085|H|an extra week (4 weeks total), you will still be protected from||
3115|086|H|pregnancy. Remove the ring and insert a new ring after 1||
3115|087|H|ring-free week. However, if you have left the ring in place||
3115|088|H|longer than 4 weeks, you may not be protected from pregnancy.||
3115|089|H|Remove the ring and contact your doctor for a pregnancy test||
3115|090|H|before inserting a new ring and use a backup form of non-hormonal||
3115|091|H|birth control (such as condoms, spermicide) for 7 days.||
3115|092|H|   Rarely, the vaginal ring has broken at the weld joint after||
3115|093|H|placement. This increases the chance of it slipping out of the||
3115|094|H|vagina. If this happens, throw it away and use a new ring.||
3115|095|H|   Ask your doctor or pharmacist about how to switch from other||
3115|096|H|forms of hormonal birth control (such as birth control pills) to||
3115|097|H|this product. If any information is unclear, consult the Patient||
3115|098|H|Information Leaflet or your doctor or pharmacist.||
3115|099|B|||
3115|100|S|SIDE EFFECTS:  Vaginal discomfort/irritation, nausea, vomiting,||
3115|101|S|headache, bloating, breast tenderness, swelling of the||
3115|102|S|ankles/feet (fluid retention), or weight change may occur.||
3115|103|S|Vaginal bleeding between periods (spotting) may occur, especially||
3115|104|S|during the first few months of use. If any of these effects last||
3115|105|S|or get worse, tell your doctor or pharmacist promptly. If you||
3115|106|S|miss 2 periods in a row (or 1 period if the ring has not been||
3115|107|S|used properly), talk to your doctor about a pregnancy test.||
3115|108|S|   Remember that this medication has been prescribed because your||
3115|109|S|doctor has judged that the benefit to you is greater than the||
3115|110|S|risk of side effects. Many people using this medication do not||
3115|111|S|have serious side effects.||
3115|112|S|   This medication may raise your blood pressure. Check your||
3115|113|S|blood pressure regularly and tell your doctor if the results are||
3115|114|S|high.||
3115|115|S|   Tell your doctor right away if you have any serious side||
3115|116|S|effects, including: lumps in the breast, mental/mood changes||
3115|117|S|(such as new/worsening depression), severe stomach/abdominal||
3115|118|S|pain, unusual changes in vaginal bleeding (such as continuous||
3115|119|S|spotting, sudden heavy bleeding, missed periods), dark urine,||
3115|120|S|yellowing eyes/skin.||
3115|121|S|   Very rarely, the ring has been accidentally placed into the||
3115|122|S|bladder. Tell your doctor right away if you have||
3115|123|S|urgent/frequent/burning/painful urination and cannot find the||
3115|124|S|ring in your vagina.||
3115|125|S|   This medication may rarely cause serious (sometimes fatal)||
3115|126|S|problems from blood clots (such as heart attack, stroke, blood||
3115|127|S|clots in the lungs or legs). Get medical help right away if you||
3115|128|S|have: chest/jaw/left arm pain, confusion, sudden||
3115|129|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
3115|130|S|trouble speaking, shortness of breath/rapid breathing,||
3115|131|S|sudden/severe headaches, unusual sweating, weakness on one side||
3115|132|S|of the body, sudden vision changes.||
3115|133|S|   Rarely, a very serious (possibly fatal) bacterial infection||
3115|134|S|(toxic shock syndrome-TSS) has occurred in women using vaginal||
3115|135|S|rings. Remove this product and get medical help right away if you||
3115|136|S|develop symptoms of toxic shock syndrome, including: sudden high||
3115|137|S|fever, severe/sudden dizziness, fainting, unusual muscle pain,||
3115|138|S|sunburn-like rash.||
3115|139|S|   A very serious allergic reaction to this drug is rare.||
3115|140|S|However, get medical help right away if you notice any symptoms||
3115|141|S|of a serious allergic reaction, including: rash, itching/swelling||
3115|142|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3115|143|S|breathing.||
3115|144|S|   This is not a complete list of possible side effects. If you||
3115|145|S|notice other effects not listed above, contact your doctor or||
3115|146|S|pharmacist.||
3115|147|S|   In the US -||
3115|148|S|   Call your doctor for medical advice about side effects. You||
3115|149|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3115|150|S|www.fda.gov/medwatch.||
3115|151|S|   In Canada - Call your doctor for medical advice about side||
3115|152|S|effects. You may report side effects to Health Canada at||
3115|153|S|1-866-234-2345.||
3115|154|B|||
3115|155|P|PRECAUTIONS:  See also Warning section.||
3115|156|P|   Before using this product, tell your doctor or pharmacist if||
3115|157|P|you are allergic to ethinyl estradiol or etonogestrel; or to||
3115|158|P|other estrogens or progestins; or if you have any other||
3115|159|P|allergies. This product may contain inactive ingredients, which||
3115|160|P|can cause allergic reactions or other problems. Talk to your||
3115|161|P|pharmacist for more details.||
3115|162|P|   Before using this medication, tell your doctor or pharmacist||
3115|163|P|your medical history, especially of: blood clots (for example, in||
3115|164|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
3115|165|P|C or protein S deficiency), high blood pressure, abnormal breast||
3115|166|P|exam, cancer (especially endometrial or breast cancer), high||
3115|167|P|cholesterol or triglyceride (blood fat) levels, depression,||
3115|168|P|diabetes, family or personal history of a certain swelling||
3115|169|P|disorder (angioedema), gallbladder problems, severe||
3115|170|P|headaches/migraines, heart problems (such as heart valve disease,||
3115|171|P|irregular heartbeat, previous heart attack), history of yellowing||
3115|172|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
3115|173|P|birth control (such as pills, patch), liver disease (including||
3115|174|P|tumors), obesity, stroke, swelling (edema), thyroid problems,||
3115|175|P|vaginal conditions (such as unexplained vaginal bleeding, vaginal||
3115|176|P|stenosis, prolapsed uterus).||
3115|177|P|   If you have diabetes, this medication may affect your blood||
3115|178|P|sugar. Check your blood sugar regularly as directed and share the||
3115|179|P|results with your doctor. Tell your doctor right away if you have||
3115|180|P|symptoms of high blood sugar such as increased thirst/urination.||
3115|181|P|Your doctor may need to adjust your diabetes medication, exercise||
3115|182|P|program, or diet.||
3115|183|P|   Tell your doctor if you just had or will be having surgery or||
3115|184|P|if you will be confined to a bed or chair for a long time (such||
3115|185|P|as a long plane flight). These conditions increase your risk of||
3115|186|P|getting blood clots, especially if you are using hormonal birth||
3115|187|P|control. You may need to stop this medication for a time or take||
3115|188|P|special precautions.||
3115|189|P|   Before having surgery, tell your doctor or dentist about all||
3115|190|P|the products you use (including prescription drugs,||
3115|191|P|nonprescription drugs, and herbal products).||
3115|192|P|   The hormones in this product may cause blotchy, dark areas on||
3115|193|P|your face and skin (melasma). Sunlight may worsen this effect.||
3115|194|P|Limit your time in the sun. Avoid tanning booths and sunlamps.||
3115|195|P|Use sunscreen and wear protective clothing when outdoors.||
3115|196|P|   If you are nearsighted or wear contact lenses, you may develop||
3115|197|P|vision problems or trouble wearing your contact lenses. Contact||
3115|198|P|your eye doctor if these problems occur.||
3115|199|P|   This medication must not be used during pregnancy. If you||
3115|200|P|become pregnant or think you may be pregnant, tell your doctor||
3115|201|P|right away. If you have just given birth or had a pregnancy||
3115|202|P|loss/abortion after the first 3 months, talk with your doctor||
3115|203|P|about reliable forms of birth control, and find out when it is||
3115|204|P|safe to start using birth control that contains a form of||
3115|205|P|estrogen, such as this medication.||
3115|206|P|   A small amount of this medication passes into breast milk and||
3115|207|P|may have undesirable effects on a nursing infant. Consult your||
3115|208|P|doctor before breastfeeding.||
3115|209|B|||
3115|210|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3115|211|I|medications work or increase your risk for serious side effects.||
3115|212|I|This document does not contain all possible drug interactions.||
3115|213|I|Keep a list of all the products you use (including||
3115|214|I|prescription/nonprescription drugs and herbal products) and share||
3115|215|I|it with your doctor and pharmacist. Do not start, stop, or change||
3115|216|I|the dosage of any medicines without your doctor's approval.||
3115|217|I|   Some products that may interact with this drug include:||
3115|218|I|aromatase inhibitors (such as anastrozole, exemestane),||
3115|219|I|fezolinetant, ospemifene, tamoxifen, tizanidine, tranexamic acid.||
3115|220|I|   Some drugs may cause hormonal birth control to work less well||
3115|221|I|by decreasing the amount of birth control hormones in your body.||
3115|222|I|This effect can result in pregnancy. Examples include||
3115|223|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
3115|224|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
3115|225|I|seizures (such as barbiturates, carbamazepine, felbamate,||
3115|226|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
3115|227|I|nevirapine), among others.||
3115|228|I|   Tell your doctor when you start any new drug, and discuss if||
3115|229|I|you should use reliable non-hormonal backup birth control. Also||
3115|230|I|tell your doctor if you have any new spotting or breakthrough||
3115|231|I|bleeding, because these may be signs that your birth control is||
3115|232|I|not working well.||
3115|233|I|   This medication may interfere with certain lab tests (such as||
3115|234|I|blood clotting factors, thyroid), possibly causing false test||
3115|235|I|results. Make sure lab personnel and all your doctors know you||
3115|236|I|use this drug.||
3115|237|B|||
3115|238|O|OVERDOSE:  This product may be harmful if swallowed. Overdose||
3115|239|O|with this product is highly unlikely. Do not use more than one||
3115|240|O|ring at a time. If someone has overdosed, remove the ring if||
3115|241|O|possible. For serious symptoms such as passing out or trouble||
3115|242|O|breathing, call 911. Otherwise, call a poison control center||
3115|243|O|right away. US residents can call 1-800-222-1222. Canada||
3115|244|O|residents can call 1-844-764-7669.||
3115|245|B|||
3115|246|N|NOTES:  Do not share this medication with others.||
3115|247|N|   Regular complete physical exams which include lab and/or||
3115|248|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
3115|249|N|Pap smear) should be done while you are using this medication.||
3115|250|N|Follow your doctor's instructions for examining your breasts, and||
3115|251|N|report any lumps right away. Keep all medical and lab||
3115|252|N|appointments. Consult your doctor for more details.||
3115|253|B|||
3115|254|D|MISSED DOSE:  Refer to the product package information for||
3115|255|D|instructions. You may need to use backup birth control (such as||
3115|256|D|condoms, spermicide) to prevent pregnancy. Ask your doctor or||
3115|257|D|pharmacist if you have any questions.||
3115|258|D|   If you have trouble remembering to remove and reinsert the||
3115|259|D|ring as directed, or if it falls out repeatedly, contact your||
3115|260|D|doctor to discuss switching to another form of birth control.||
3115|261|B|||
3115|262|R|STORAGE:  Different brands of this product have different storage||
3115|263|R|needs. Check the product package for instructions on how to store||
3115|264|R|your brand, or ask your pharmacist. Do not use after 4 months or||
3115|265|R|after the expiration date, whichever comes first. Keep all||
3115|266|R|medications away from children and pets.||
3115|267|R|   Do not flush medications down the toilet or pour them into a||
3115|268|R|drain unless instructed to do so. Properly discard this product||
3115|269|R|when it is expired or no longer needed. (See also How to Use||
3115|270|R|section.)||
3115|271|B|||
3115|272|A|Information last revised October 2025.||
3115|273|A|Copyright(c) 2025 First Databank, Inc.||
3115|274|B|||
3116|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3116|002|Z|does NOT have all possible information about this product. This||
3116|003|Z|information does not assure that this product is safe, effective,||
3116|004|Z|or appropriate for you. This information is not individual||
3116|005|Z|medical advice and does not substitute for the advice of your||
3116|006|Z|health care professional. Always ask your health care||
3116|007|Z|professional for complete information about this product and your||
3116|008|Z|specific health needs.||
3116|009|B|||
3116|010|T|TESTOSTERONE GEL - TRANSDERMAL||
3116|011|F|(tess-TOSS-ter-own)||
3116|012|B|||
3116|013|C|COMMON BRAND NAME(S): Androgel, Testim||
3116|014|B|||
3116|015|W|WARNING:  Children accidentally exposed to this medication by||
3116|016|W|direct contact with someone using it may absorb this drug through||
3116|017|W|their skin. If this occurs, the child may have unwanted side||
3116|018|W|effects due to testosterone gel. Children should avoid contact||
3116|019|W|with the unwashed or unclothed area where the medication has been||
3116|020|W|applied. Tell both of your doctors right away if you notice||
3116|021|W|unexpected signs of puberty in a child such as unusual increase||
3116|022|W|in size of genitals (penis or clitoris), early development of||
3116|023|W|pubic hair, increased erections (in boys) or sex drive, or||
3116|024|W|aggressive behavior. To decrease this risk, carefully follow all||
3116|025|W|directions for the proper use of this drug.||
3116|026|B|||
3116|027|U|USES:  This medicated gel contains testosterone. It is used for||
3116|028|U|hormone replacement in men who are not able to produce enough||
3116|029|U|testosterone (for example, due to hypogonadism). This medication||
3116|030|U|is absorbed through the skin, enters your bloodstream, and helps||
3116|031|U|your body reach normal testosterone levels.||
3116|032|U|   Testosterone helps the body to develop and maintain the male||
3116|033|U|sexual characteristics (masculinity), such as a deep voice and||
3116|034|U|body hair. It also helps to maintain muscle and prevent bone||
3116|035|U|loss, and is necessary for natural sexual ability/desire.||
3116|036|U|   This drug should not be used by women.||
3116|037|B|||
3116|038|H|HOW TO USE:  Read the Medication Guide and, if available, the||
3116|039|H|Patient Information Leaflet provided by your pharmacist before||
3116|040|H|you start using testosterone gel and each time you get a refill.||
3116|041|H|If you have any questions, ask your doctor or pharmacist.||
3116|042|H|   There are many testosterone products available for use on the||
3116|043|H|skin. They may have different amounts of testosterone and may not||
3116|044|H|have the same effects. Read the dosing instructions carefully for||
3116|045|H|each product. Do not change products without asking your doctor||
3116|046|H|or pharmacist.||
3116|047|H|   If you are using the gel pump, learn how to prepare the pump||
3116|048|H|for use. You may pump this medication into the palm of your hand||
3116|049|H|or directly onto the desired application site. If you are not||
3116|050|H|sure how to use the pump, ask your pharmacist.||
3116|051|H|   Apply the medication as directed to clean, dry skin of the||
3116|052|H|shoulders/upper arms as directed by your doctor, usually once||
3116|053|H|daily in the morning. Apply only to areas that would be covered||
3116|054|H|if you were to wear a short sleeve t-shirt. Certain brands of||
3116|055|H|this medication may also be applied to the stomach area||
3116|056|H|(abdomen). Check your product's instructions or ask your||
3116|057|H|pharmacist if your brand may be applied to the abdomen. Avoid||
3116|058|H|applying this medication to broken, irritated skin. Do not apply||
3116|059|H|to the genitals (penis or scrotum). Do not let others apply this||
3116|060|H|medication to your body.||
3116|061|H|   The dosage is based on your medical condition, lab tests, and||
3116|062|H|response to treatment.||
3116|063|H|   After applying this medication, wash your hands thoroughly||
3116|064|H|with soap and water to reduce the risk of accidentally spreading||
3116|065|H|it from your hands to other people. Before dressing, wait a few||
3116|066|H|minutes for the application site to dry completely. Be sure to||
3116|067|H|always wear clothing (such as a t-shirt) to cover the application||
3116|068|H|site until you wash the areas well with soap and water.||
3116|069|H|   To get the best effect, wait several hours (2 to 5 hours||
3116|070|H|depending on brand) before showering/swimming to allow the drug||
3116|071|H|to be absorbed through the skin. Check the manufacturer's||
3116|072|H|information or ask your pharmacist for details. See also Warning||
3116|073|H|and Precautions sections.||
3116|074|H|   Use this medication regularly in order to get the most benefit||
3116|075|H|from it. To help you remember, use it at the same time each day.||
3116|076|H|   Misuse or abuse of testosterone can cause serious side effects||
3116|077|H|such as heart disease (including heart attack), stroke, liver||
3116|078|H|disease, mental/mood problems, abnormal drug-seeking behavior, or||
3116|079|H|improper bone growth (in adolescents). Do not increase your dose||
3116|080|H|or use this drug more often or for longer than prescribed. When||
3116|081|H|testosterone is misused or abused, you may have withdrawal||
3116|082|H|symptoms (such as depression, irritability, tiredness) when you||
3116|083|H|suddenly stop using the drug. These symptoms may last from weeks||
3116|084|H|to months.||
3116|085|H|   This medication is flammable until dry. Avoid smoking or being||
3116|086|H|near open flames while using the medication and until the||
3116|087|H|medication has dried.||
3116|088|H|   Tell your doctor if your condition does not get better or if||
3116|089|H|it gets worse.||
3116|090|B|||
3116|091|S|SIDE EFFECTS:  Nausea, vomiting, headache, dizziness, hair loss,||
3116|092|S|trouble sleeping, change in sexual desire, redness/swelling of||
3116|093|S|the skin, change in skin color, and acne may occur. If any of||
3116|094|S|these effects last or get worse, tell your doctor or pharmacist||
3116|095|S|promptly.||
3116|096|S|   This medication may raise your blood pressure. Check your||
3116|097|S|blood pressure regularly and tell your doctor if the results are||
3116|098|S|high. Your doctor may control your blood pressure with||
3116|099|S|medication.||
3116|100|S|   Remember that this medication has been prescribed because your||
3116|101|S|doctor has judged that the benefit to you is greater than the||
3116|102|S|risk of side effects. Many people using this medication do not||
3116|103|S|have serious side effects.||
3116|104|S|   Tell your doctor right away if you have any serious side||
3116|105|S|effects, including: breast pain/enlargement, swelling of the||
3116|106|S|feet/ankles (edema), weight gain, very slow/shallow/difficult||
3116|107|S|breathing (possibly while sleeping), weakness, trouble urinating,||
3116|108|S|increased urination (especially at night), mental/mood changes||
3116|109|S|(such as depression, agitation, hostility), change in size/shape||
3116|110|S|of the testicles, testicle pain/tenderness, stomach/abdominal||
3116|111|S|pain, dark urine, yellowing of eyes/skin, fast/irregular||
3116|112|S|heartbeat.||
3116|113|S|   Get medical help right away if you have any very serious side||
3116|114|S|effects, including: shortness of breath/rapid breathing,||
3116|115|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
3116|116|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
3116|117|S|sudden/severe headaches, trouble speaking, weakness on one side||
3116|118|S|of the body, sudden vision changes.||
3116|119|S|   In patients with diabetes, especially those taking insulin,||
3116|120|S|testosterone may decrease your blood sugar. Be prepared to treat||
3116|121|S|low blood sugar while you are using this medication. Symptoms of||
3116|122|S|low blood sugar include shakiness, nervousness, rapid pulse, and||
3116|123|S|sweating. If you are experiencing these symptoms, consult your||
3116|124|S|doctor. Your doctor may need to adjust your diabetes medications.||
3116|125|S|   Rarely, males may have a painful or prolonged erection lasting||
3116|126|S|4 or more hours. If this occurs, stop using this drug and get||
3116|127|S|medical help right away, or permanent problems could occur.||
3116|128|S|   A very serious allergic reaction to this drug is rare.||
3116|129|S|However, get medical help right away if you notice any symptoms||
3116|130|S|of a serious allergic reaction, including: rash, itching/swelling||
3116|131|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3116|132|S|breathing.||
3116|133|S|   This is not a complete list of possible side effects. If you||
3116|134|S|notice other effects not listed above, contact your doctor or||
3116|135|S|pharmacist.||
3116|136|S|   In the US -||
3116|137|S|   Call your doctor for medical advice about side effects. You||
3116|138|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3116|139|S|www.fda.gov/medwatch.||
3116|140|S|   In Canada - Call your doctor for medical advice about side||
3116|141|S|effects. You may report side effects to Health Canada at||
3116|142|S|1-866-234-2345.||
3116|143|B|||
3116|144|P|PRECAUTIONS:  Before using testosterone, tell your doctor or||
3116|145|P|pharmacist if you are allergic to it; or if you have any other||
3116|146|P|allergies. This product may contain inactive ingredients (such as||
3116|147|P|soy), which can cause allergic reactions or other problems. Talk||
3116|148|P|to your pharmacist for more details.||
3116|149|P|   Before using this medication, tell your doctor or pharmacist||
3116|150|P|your medical history, especially of: breast cancer (males),||
3116|151|P|prostate problems (such as cancer, enlarged prostate or BPH),||
3116|152|P|liver problems, heart problems (such as heart failure, heart||
3116|153|P|attack), stroke, kidney problems, diabetes, high cholesterol||
3116|154|P|level, lung disease, obesity, difficulty breathing during sleep||
3116|155|P|(apnea), high blood pressure, bone cancer, blood clots (such as||
3116|156|P|in the leg, lungs).||
3116|157|P|   Direct contact with the application site can expose others to||
3116|158|P|this medication. Women and children should avoid contact with the||
3116|159|P|unwashed or unclothed area where the medication has been applied.||
3116|160|P|If you expect to have skin-to-skin contact with another person,||
3116|161|P|first wash the application area well with soap and water. If a||
3116|162|P|woman or child makes contact with the application area, that area||
3116|163|P|on the woman or child should be washed well with soap and water||
3116|164|P|right away.||
3116|165|P|   If this medication accidentally gets into your eyes, rinse the||
3116|166|P|eyes right away with clean, warm water. Get medical help right||
3116|167|P|away if necessary.||
3116|168|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3116|169|P|can make you more dizzy. Do not drive, use machinery, or do||
3116|170|P|anything that needs alertness until you can do it safely. Limit||
3116|171|P|alcoholic beverages. Talk to your doctor if you are using||
3116|172|P|marijuana (cannabis).||
3116|173|P|   Before having surgery, tell your doctor or dentist about all||
3116|174|P|the products you use (including prescription drugs,||
3116|175|P|nonprescription drugs, and herbal products).||
3116|176|P|   Some men, especially older adults, are at a higher risk for||
3116|177|P|developing enlarged prostates or prostate cancer while using this||
3116|178|P|medication. Your risk of prostate problems should be checked by||
3116|179|P|your doctor before you start testosterone.||
3116|180|P|   Children may be more sensitive to the side effects of this||
3116|181|P|drug. In children, it may affect bone growth. Monitor your||
3116|182|P|child's height periodically.||
3116|183|P|   This medication can affect fertility in males. Ask your doctor||
3116|184|P|for more details.||
3116|185|P|   This medication should not be used by women. Women||
3116|186|P|accidentally exposed to this medication may have side effects due||
3116|187|P|to testosterone gel. If you notice symptoms in a woman such as||
3116|188|P|changes in body hair or a large increase in acne, talk to her||
3116|189|P|doctor and your doctor right away. Women who are pregnant or||
3116|190|P|breastfeeding must avoid contact with this medication. This||
3116|191|P|medication may harm an unborn or breastfeeding baby. Consult your||
3116|192|P|doctor for more details.||
3116|193|B|||
3116|194|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3116|195|I|medications work or increase your risk for serious side effects.||
3116|196|I|This document does not contain all possible drug interactions.||
3116|197|I|Keep a list of all the products you use (including||
3116|198|I|prescription/nonprescription drugs and herbal products) and share||
3116|199|I|it with your doctor and pharmacist. Do not start, stop, or change||
3116|200|I|the dosage of any medicines without your doctor's approval.||
3116|201|I|   Some products that may interact with this drug include: "blood||
3116|202|I|thinners" (such as warfarin).||
3116|203|I|   This medication may interfere with certain lab tests (such as||
3116|204|I|thyroid function tests, creatinine level), possibly causing false||
3116|205|I|test results. Make sure lab personnel and all your doctors know||
3116|206|I|you use this drug.||
3116|207|B|||
3116|208|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3116|209|O|has overdosed and has serious symptoms such as passing out or||
3116|210|O|trouble breathing, call 911. Otherwise, call a poison control||
3116|211|O|center right away. US residents can call 1-800-222-1222. Canada||
3116|212|O|residents can call 1-844-764-7669. Symptoms of an overdose may||
3116|213|O|include: weakness on one side of the body, trouble speaking,||
3116|214|O|vision problems, or confusion.||
3116|215|B|||
3116|216|N|NOTES:  Do not share this medication with others. Sharing it is||
3116|217|N|against the law.||
3116|218|N|   Lab and/or medical tests (such as PSA, cholesterol,||
3116|219|N|hemoglobin, hematocrit, testosterone blood levels, prostate||
3116|220|N|exams) should be done while you are using this medication. Keep||
3116|221|N|all medical and lab appointments. Consult your doctor for more||
3116|222|N|details.||
3116|223|N|   This medication has been prescribed for your current condition||
3116|224|N|only. Do not use it later for another problem unless told to do||
3116|225|N|so by your doctor. A different medication may be necessary in||
3116|226|N|those cases.||
3116|227|B|||
3116|228|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3116|229|D|If it is less than 12 hours before the next dose, skip the missed||
3116|230|D|dose. Use your next dose at the regular time. Do not double the||
3116|231|D|dose to catch up.||
3116|232|B|||
3116|233|R|STORAGE:  Store at room temperature. Do not store near an open||
3116|234|R|flame. Discard used medication packages in a secure trash can.||
3116|235|R|Keep all medications away from children and pets.||
3116|236|R|   Do not flush medications down the toilet or pour them into a||
3116|237|R|drain unless instructed to do so. Properly discard this product||
3116|238|R|when it is expired or no longer needed. Consult your pharmacist||
3116|239|R|or local waste disposal company.||
3116|240|B|||
3116|241|A|Information last revised July 2025.||
3116|242|A|Copyright(c) 2025 First Databank, Inc.||
3116|243|B|||
3128|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3128|002|Z|does NOT have all possible information about this product. This||
3128|003|Z|information does not assure that this product is safe, effective,||
3128|004|Z|or appropriate for you. This information is not individual||
3128|005|Z|medical advice and does not substitute for the advice of your||
3128|006|Z|health care professional. Always ask your health care||
3128|007|Z|professional for complete information about this product and your||
3128|008|Z|specific health needs.||
3128|009|B|||
3128|010|T|QUININE SULFATE (ANTIMALARIAL) - ORAL||
3128|011|F|(KWEYE-nine SUL-fate)||
3128|012|B|||
3128|013|C|COMMON BRAND NAME(S): Qualaquin||
3128|014|B|||
3128|015|W|WARNING:  The US Food and Drug Administration (FDA) warns that||
3128|016|W|quinine should not be used to treat leg cramps. It has not been||
3128|017|W|shown to work for this use and may cause serious side effects.||
3128|018|W|Consult your doctor or pharmacist for more details.||
3128|019|B|||
3128|020|U|USES:  This medication is used alone or with other medication to||
3128|021|U|treat malaria caused by mosquito bites in countries where malaria||
3128|022|U|is common. Malaria parasites can enter the body through these||
3128|023|U|mosquito bites, and then live in body tissues such as red blood||
3128|024|U|cells or the liver. This medication is used to kill the malaria||
3128|025|U|parasites living inside red blood cells. In some cases, you may||
3128|026|U|need to take a different medication (such as primaquine) to kill||
3128|027|U|the malaria parasites living in other body tissues. Both drugs||
3128|028|U|may be needed for a complete cure and to prevent the return of||
3128|029|U|infection (relapse). Quinine belongs to a class of drugs known as||
3128|030|U|antimalarials. It is not used for the prevention of malaria.||
3128|031|U|   The United States Centers for Disease Control provide updated||
3128|032|U|guidelines and travel recommendations for the prevention and||
3128|033|U|treatment of malaria in different parts of the world. Discuss the||
3128|034|U|most recent information with your doctor before traveling to||
3128|035|U|areas where malaria occurs.||
3128|036|B|||
3128|037|H|HOW TO USE:  Read the Medication Guide and, if available, the||
3128|038|H|Patient Information Leaflet provided by your pharmacist before||
3128|039|H|you start taking quinine and each time you get a refill. If you||
3128|040|H|have any questions, ask your doctor or pharmacist.||
3128|041|H|   Take this medication by mouth with food (to decrease upset||
3128|042|H|stomach) as directed by your doctor, usually every 8 hours for 3||
3128|043|H|to 7 days.||
3128|044|H|   Take this medication 2 to 3 hours before or after taking||
3128|045|H|antacids containing aluminum or magnesium. These products bind||
3128|046|H|with quinine, preventing your body from fully absorbing the drug.||
3128|047|H|   The dosage and length of treatment are based on your medical||
3128|048|H|condition, country where you were infected, other medications you||
3128|049|H|may be taking for malaria, and your response to treatment.||
3128|050|H|Children's dosage is also based on weight.||
3128|051|H|   It is very important to keep taking this medication (and other||
3128|052|H|malaria medications) exactly as prescribed by your doctor. Do not||
3128|053|H|take more or less of this drug than prescribed. Do not skip any||
3128|054|H|doses. Continue to take this medication until the full prescribed||
3128|055|H|amount is finished, even if symptoms disappear after a few days.||
3128|056|H|Skipping doses or stopping the medication too early may make the||
3128|057|H|infection more difficult to treat and result in a return of the||
3128|058|H|infection.||
3128|059|H|   This medication works best when the amount of drug in your||
3128|060|H|body is kept at a constant level. Take this drug at evenly spaced||
3128|061|H|intervals. To help you remember, take it at the same times each||
3128|062|H|day.||
3128|063|H|   Tell your doctor if you do not start feeling better after 1 to||
3128|064|H|2 days of starting this medication. If your fever returns after||
3128|065|H|completing this prescription, contact your doctor so that he/she||
3128|066|H|can determine whether the malaria has returned.||
3128|067|B|||
3128|068|S|SIDE EFFECTS:  Mild headache, flushing, unusual sweating, nausea,||
3128|069|S|ringing in the ears, decreased hearing, dizziness, blurred||
3128|070|S|vision, or temporary changes in color vision may occur. If any of||
3128|071|S|these effects last or get worse, tell your doctor or pharmacist||
3128|072|S|promptly.||
3128|073|S|   Remember that this medication has been prescribed because your||
3128|074|S|doctor has judged that the benefit to you is greater than the||
3128|075|S|risk of side effects. Many people using this medication do not||
3128|076|S|have serious side effects.||
3128|077|S|   Tell your doctor right away if you have any serious side||
3128|078|S|effects, including: easy bruising/bleeding, unusual||
3128|079|S|purple/brown/red spots on the skin, signs of infection (such as||
3128|080|S|sore throat that doesn't go away, fever, chills), signs of anemia||
3128|081|S|(such as unusual tiredness, brown urine, pale skin, rapid||
3128|082|S|breathing), signs of liver problems (such as nausea/vomiting that||
3128|083|S|doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark||
3128|084|S|urine), signs of kidney problems (such as change in the amount of||
3128|085|S|urine).||
3128|086|S|   Quinine may cause low blood sugar (hypoglycemia), especially||
3128|087|S|during pregnancy. Symptoms of low blood sugar include sudden||
3128|088|S|sweating, shaking, fast heartbeat, hunger, blurred vision,||
3128|089|S|dizziness, or tingling hands/feet. If symptoms of low blood sugar||
3128|090|S|occur, increase your blood sugar by eating a quick source of||
3128|091|S|sugar such as table sugar, honey, or candy, or drink fruit juice||
3128|092|S|or non-diet soda. Tell your doctor right away about the reaction||
3128|093|S|and the use of this product.||
3128|094|S|   Get medical help right away if you have any very serious side||
3128|095|S|effects, including: chest pain, severe dizziness, fainting,||
3128|096|S|fast/irregular heartbeat, blindness.||
3128|097|S|   A very serious allergic reaction to this drug is rare.||
3128|098|S|However, get medical help right away if you notice any symptoms||
3128|099|S|of a serious allergic reaction, including: rash, itching/swelling||
3128|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3128|101|S|breathing.||
3128|102|S|   This is not a complete list of possible side effects. If you||
3128|103|S|notice other effects not listed above, contact your doctor or||
3128|104|S|pharmacist.||
3128|105|S|   In the US -||
3128|106|S|   Call your doctor for medical advice about side effects. You||
3128|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3128|108|S|www.fda.gov/medwatch.||
3128|109|S|   In Canada - Call your doctor for medical advice about side||
3128|110|S|effects. You may report side effects to Health Canada at||
3128|111|S|1-866-234-2345.||
3128|112|B|||
3128|113|P|PRECAUTIONS:  Before taking quinine, tell your doctor or||
3128|114|P|pharmacist if you are allergic to it; or to quinidine or||
3128|115|P|mefloquine; or if you have any other allergies. This product may||
3128|116|P|contain inactive ingredients, which can cause allergic reactions||
3128|117|P|or other problems. Talk to your pharmacist for more details.||
3128|118|P|   Before using this medication, tell your doctor or pharmacist||
3128|119|P|your medical history, especially of: previous serious side||
3128|120|P|effects with quinine (such as blood problems), family/personal||
3128|121|P|history of a certain enzyme problem (glucose-6-phosphate||
3128|122|P|dehydrogenase deficiency-G6PD), a certain eye nerve problem||
3128|123|P|(optic neuritis), hearing problems (such as ringing in the ears),||
3128|124|P|a certain nerve/muscle disease (myasthenia gravis), heart rhythm||
3128|125|P|problems (such as atrial fibrillation/flutter), kidney problems,||
3128|126|P|liver problems.||
3128|127|P|   This drug may make you dizzy or blur your vision. Alcohol or||
3128|128|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
3128|129|P|machinery, or do anything that needs alertness or clear vision||
3128|130|P|until you can do it safely. Limit alcoholic beverages. Talk to||
3128|131|P|your doctor if you are using marijuana (cannabis).||
3128|132|P|   Before having surgery, tell your doctor or dentist about all||
3128|133|P|the products you use (including prescription drugs,||
3128|134|P|nonprescription drugs, and herbal products).||
3128|135|P|   Quinine may cause a condition that affects the heart rhythm||
3128|136|P|(QT prolongation). QT prolongation can rarely cause serious||
3128|137|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
3128|138|P|as severe dizziness, fainting) that need medical attention right||
3128|139|P|away.||
3128|140|P|   The risk of QT prolongation may be increased if you have||
3128|141|P|certain medical conditions or are taking other drugs that may||
3128|142|P|cause QT prolongation. Before using quinine, tell your doctor or||
3128|143|P|pharmacist of all the drugs you take and if you have any of the||
3128|144|P|following conditions: certain heart problems (heart failure, slow||
3128|145|P|heartbeat, QT prolongation in the EKG), family history of certain||
3128|146|P|heart problems (QT prolongation in the EKG, sudden cardiac||
3128|147|P|death).||
3128|148|P|   Low levels of potassium or magnesium in the blood may also||
3128|149|P|increase your risk of QT prolongation. This risk may increase if||
3128|150|P|you use certain drugs (such as diuretics/"water pills") or if you||
3128|151|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3128|152|P|Talk to your doctor about using quinine safely.||
3128|153|P|   Older adults may be more sensitive to the side effects of this||
3128|154|P|drug, especially QT prolongation (see above).||
3128|155|P|   During pregnancy, this medication should be used only when||
3128|156|P|clearly needed. Discuss the risks, benefits, and treatment||
3128|157|P|options with your doctor. Untreated malaria is a serious||
3128|158|P|condition that can harm both a pregnant woman and her unborn||
3128|159|P|baby.||
3128|160|P|   This drug passes into breast milk. However, this drug is||
3128|161|P|unlikely to harm some nursing infants. Your doctor will test your||
3128|162|P|infant for a certain enzyme deficiency (glucose-6-phosphate||
3128|163|P|dehydrogenase deficiency-G6PD) before you breastfeed. Consult||
3128|164|P|your doctor before breastfeeding.||
3128|165|B|||
3128|166|I|DRUG INTERACTIONS:  See also How to Use section.||
3128|167|I|   Drug interactions may change how your medications work or||
3128|168|I|increase your risk for serious side effects. This document does||
3128|169|I|not contain all possible drug interactions. Keep a list of all||
3128|170|I|the products you use (including prescription/nonprescription||
3128|171|I|drugs and herbal products) and share it with your doctor and||
3128|172|I|pharmacist. Do not start, stop, or change the dosage of any||
3128|173|I|medicines without your doctor's approval.||
3128|174|I|   Some products that may interact with this drug include: "blood||
3128|175|I|thinners" (such as warfarin), penicillamine.||
3128|176|I|   Other medications can affect the removal of quinine from your||
3128|177|I|body, which may affect how quinine works. Examples include||
3128|178|I|cimetidine, erythromycin, ketoconazole, phenytoin, rifampin, HIV||
3128|179|I|protease inhibitors (such as lopinavir), ritonavir, urinary||
3128|180|I|alkalinizers such as sodium bicarbonate, among others.||
3128|181|I|   This medication can slow down the removal of other medications||
3128|182|I|from your body, which may affect how they work. Examples of||
3128|183|I|affected drugs include desipramine, digoxin, certain "statin"||
3128|184|I|drugs (atorvastatin, lovastatin, simvastatin), phenobarbital,||
3128|185|I|among others.||
3128|186|I|   Many drugs besides quinine may affect the heart rhythm (QT||
3128|187|I|prolongation), including amiodarone, dofetilide, mefloquine,||
3128|188|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
3128|189|I|(such as erythromycin), among others. Before using quinine,||
3128|190|I|report all medications you are currently using to your doctor or||
3128|191|I|pharmacist.||
3128|192|I|   Quinine is very similar to quinidine. Do not use medications||
3128|193|I|containing quinidine while using quinine.||
3128|194|I|   This medication may interfere with certain lab tests (such as||
3128|195|I|certain urine tests for catecholamines, protein, steroids),||
3128|196|I|possibly causing false test results. Make sure lab personnel and||
3128|197|I|all your doctors know you use this drug.||
3128|198|B|||
3128|199|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3128|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3128|201|O|poison control center right away. US residents can call||
3128|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3128|203|O|Symptoms of overdose may include: sudden vision change,||
3128|204|O|confusion, severe trouble hearing, fast/irregular heartbeat,||
3128|205|O|fainting, slow/shallow breathing, seizures, inability to wake up||
3128|206|O|(coma).||
3128|207|B|||
3128|208|N|NOTES:  Do not share this medication with others.||
3128|209|N|   Lab and/or medical tests (such as G6PD blood level, vision||
3128|210|N|tests, blood potassium, liver/kidney function, EKG) may be done||
3128|211|N|while you are taking this medication. Keep all medical and lab||
3128|212|N|appointments. Consult your doctor for more details.||
3128|213|B|||
3128|214|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3128|215|D|remember. If it is more than 4 hours after the missed dose, skip||
3128|216|D|the missed dose. Take your next dose at the regular time. Do not||
3128|217|D|double the dose to catch up.||
3128|218|B|||
3128|219|R|STORAGE:  Store at room temperature away from light and moisture.||
3128|220|R|Do not store in the bathroom. Keep all medications away from||
3128|221|R|children and pets.||
3128|222|R|   Do not flush medications down the toilet or pour them into a||
3128|223|R|drain unless instructed to do so. Properly discard this product||
3128|224|R|when it is expired or no longer needed. Consult your pharmacist||
3128|225|R|or local waste disposal company.||
3128|226|B|||
3128|227|A|Information last revised May 2025.||
3128|228|A|Copyright(c) 2025 First Databank, Inc.||
3128|229|B|||
3132|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3132|002|Z|does NOT have all possible information about this product. This||
3132|003|Z|information does not assure that this product is safe, effective,||
3132|004|Z|or appropriate for you. This information is not individual||
3132|005|Z|medical advice and does not substitute for the advice of your||
3132|006|Z|health care professional. Always ask your health care||
3132|007|Z|professional for complete information about this product and your||
3132|008|Z|specific health needs.||
3132|009|B|||
3132|010|T|GRANISETRON - ORAL||
3132|011|F|(gra-NIS-e-tron)||
3132|012|B|||
3132|013|C|COMMON BRAND NAME(S): Kytril||
3132|014|B|||
3132|015|U|USES:  This medication is used to prevent nausea and vomiting due||
3132|016|U|to cancer drug treatment (chemotherapy) and radiation therapy. It||
3132|017|U|works by blocking one of the body's chemicals (serotonin) that||
3132|018|U|causes vomiting.||
3132|019|B|||
3132|020|H|HOW TO USE:  Take this medication by mouth. It is important to||
3132|021|H|follow your doctor's instructions for the timing of each dose. If||
3132|022|H|you have any questions, consult your doctor or pharmacist.||
3132|023|H|   Tell your doctor if your condition lasts or gets worse.||
3132|024|B|||
3132|025|S|SIDE EFFECTS:  Diarrhea, constipation, stomach pain, weakness,||
3132|026|S|headache, fever, dizziness, drowsiness, trouble sleeping, and||
3132|027|S|anxiety may occur. If any of these effects last or get worse,||
3132|028|S|notify your doctor or pharmacist promptly.||
3132|029|S|   Remember that this medication has been prescribed because your||
3132|030|S|doctor has judged that the benefit to you is greater than the||
3132|031|S|risk of side effects. Many people using this medication do not||
3132|032|S|have serious side effects.||
3132|033|S|   Tell your doctor right away if you have any serious side||
3132|034|S|effects, including: unusual muscle movements or stiffness.||
3132|035|S|   Get medical help right away if you have any very serious side||
3132|036|S|effects, including: chest pain, fast/irregular heartbeat, severe||
3132|037|S|dizziness, fainting.||
3132|038|S|   This medication may increase serotonin and rarely cause a very||
3132|039|S|serious condition called serotonin syndrome/toxicity. The risk||
3132|040|S|increases if you are also taking other drugs that increase||
3132|041|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
3132|042|S|take (see Drug Interactions section). Get medical help right away||
3132|043|S|if you develop some of the following symptoms: fast heartbeat,||
3132|044|S|hallucinations, loss of coordination, severe dizziness, severe||
3132|045|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
3132|046|S|unusual agitation/restlessness.||
3132|047|S|   A very serious allergic reaction to this drug is rare.||
3132|048|S|However, get medical help right away if you notice any symptoms||
3132|049|S|of a serious allergic reaction, including: rash, itching/swelling||
3132|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3132|051|S|breathing.||
3132|052|S|   This is not a complete list of possible side effects. If you||
3132|053|S|notice other effects not listed above, contact your doctor or||
3132|054|S|pharmacist.||
3132|055|S|   In the US -||
3132|056|S|   Call your doctor for medical advice about side effects. You||
3132|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3132|058|S|www.fda.gov/medwatch.||
3132|059|S|   In Canada - Call your doctor for medical advice about side||
3132|060|S|effects. You may report side effects to Health Canada at||
3132|061|S|1-866-234-2345.||
3132|062|B|||
3132|063|P|PRECAUTIONS:  Before taking granisetron, tell your doctor or||
3132|064|P|pharmacist if you are allergic to it; or if you have any other||
3132|065|P|allergies. This product may contain inactive ingredients, which||
3132|066|P|can cause allergic reactions or other problems. Talk to your||
3132|067|P|pharmacist for more details.||
3132|068|P|   Before using this medication, tell your doctor or pharmacist||
3132|069|P|your medical history.||
3132|070|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3132|071|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3132|072|P|machinery, or do anything that needs alertness until you can do||
3132|073|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
3132|074|P|are using marijuana (cannabis).||
3132|075|P|   Granisetron may cause a condition that affects the heart||
3132|076|P|rhythm (QT prolongation). QT prolongation can rarely cause||
3132|077|P|serious (rarely fatal) fast/irregular heartbeat and other||
3132|078|P|symptoms (such as severe dizziness, fainting) that need medical||
3132|079|P|attention right away.||
3132|080|P|   The risk of QT prolongation may be increased if you have||
3132|081|P|certain medical conditions or are taking other drugs that may||
3132|082|P|cause QT prolongation. Before using granisetron, tell your doctor||
3132|083|P|or pharmacist of all the drugs you take and if you have any of||
3132|084|P|the following conditions: certain heart problems (heart failure,||
3132|085|P|slow heartbeat, QT prolongation in the EKG), family history of||
3132|086|P|certain heart problems (QT prolongation in the EKG, sudden||
3132|087|P|cardiac death).||
3132|088|P|   Low levels of potassium or magnesium in the blood may also||
3132|089|P|increase your risk of QT prolongation. This risk may increase if||
3132|090|P|you use certain drugs (such as diuretics/"water pills") or if you||
3132|091|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3132|092|P|Talk to your doctor about using granisetron safely.||
3132|093|P|   Older adults may be more sensitive to the side effects of this||
3132|094|P|drug, especially QT prolongation (see above).||
3132|095|P|   During pregnancy, this medication should be used only when||
3132|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
3132|097|P|   It is unknown if this drug passes into breast milk. Consult||
3132|098|P|your doctor before breastfeeding.||
3132|099|B|||
3132|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3132|101|I|medications work or increase your risk for serious side effects.||
3132|102|I|This document does not contain all possible drug interactions.||
3132|103|I|Keep a list of all the products you use (including||
3132|104|I|prescription/nonprescription drugs and herbal products) and share||
3132|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
3132|106|I|the dosage of any medicines without your doctor's approval.||
3132|107|I|   A product that may interact with this drug is: apomorphine.||
3132|108|I|   Many drugs besides granisetron may affect the heart rhythm (QT||
3132|109|I|prolongation), including amiodarone, dofetilide, pimozide,||
3132|110|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
3132|111|I|erythromycin), among others.||
3132|112|I|   The risk of serotonin syndrome/toxicity increases if you are||
3132|113|I|also taking other drugs that increase serotonin. Examples include||
3132|114|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
3132|115|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
3132|116|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
3132|117|I|serotonin syndrome/toxicity may be more likely when you start or||
3132|118|I|increase the dose of these drugs.||
3132|119|B|||
3132|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3132|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3132|122|O|poison control center right away. US residents can call||
3132|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3132|124|B|||
3132|125|N|NOTES:  Do not share this medication with others.||
3132|126|B|||
3132|127|D|MISSED DOSE:  It is important to take each dose of this||
3132|128|D|medication as scheduled. If you miss a dose, ask your doctor or||
3132|129|D|pharmacist right away for a new dosing schedule.||
3132|130|B|||
3132|131|R|STORAGE:  Store at room temperature away from light and moisture.||
3132|132|R|Do not store in the bathroom. Store the oral solution in an||
3132|133|R|upright position. Keep all medications away from children and||
3132|134|R|pets.||
3132|135|R|   Do not flush medications down the toilet or pour them into a||
3132|136|R|drain unless instructed to do so. Properly discard this product||
3132|137|R|when it is expired or no longer needed. Consult your pharmacist||
3132|138|R|or local waste disposal company.||
3132|139|B|||
3132|140|A|Information last revised May 2024.||
3132|141|A|Copyright(c) 2025 First Databank, Inc.||
3132|142|B|||
3133|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3133|002|Z|does NOT have all possible information about this product. This||
3133|003|Z|information does not assure that this product is safe, effective,||
3133|004|Z|or appropriate for you. This information is not individual||
3133|005|Z|medical advice and does not substitute for the advice of your||
3133|006|Z|health care professional. Always ask your health care||
3133|007|Z|professional for complete information about this product and your||
3133|008|Z|specific health needs.||
3133|009|B|||
3133|010|T|ALDESLEUKIN - INJECTION||
3133|011|F|(AL-des-LOO-kin)||
3133|012|B|||
3133|013|C|COMMON BRAND NAME(S): Proleukin||
3133|014|B|||
3133|015|W|WARNING:  Aldesleukin must be given in a hospital setting by a||
3133|016|W|health care professional. It must be used with extreme caution in||
3133|017|W|patients with heart or lung problems.||
3133|018|W|   Rarely, this medication can cause capillary leak syndrome||
3133|019|W|(CLS), a serious condition that can sometimes be fatal. If you||
3133|020|W|develop any of the following signs of CLS, tell your doctor right||
3133|021|W|away: swelling, severe dizziness, fainting, irregular heartbeat,||
3133|022|W|chest pain (angina), trouble breathing, signs of kidney problems||
3133|023|W|(such as change in the amount of urine), mental/mood changes,||
3133|024|W|severe stomach/abdominal pain, black stools.||
3133|025|W|   Aldesleukin can also make you more likely to get serious||
3133|026|W|infections. Before using this drug, tell your doctor if you||
3133|027|W|currently have any infections. Also, tell your doctor right away||
3133|028|W|if you develop any of the following signs of infection: sore||
3133|029|W|throat that doesn't go away, fever, chills.||
3133|030|W|   Rarely, this drug may cause a loss of consciousness. If this||
3133|031|W|drug makes you unusually sleepy, stop using it and tell your||
3133|032|W|doctor right away.||
3133|033|B|||
3133|034|U|USES:  Aldesleukin is used to treat kidney or skin cancer. This||
3133|035|U|medication is the same as a substance that your body normally||
3133|036|U|makes (interleukin-2). In the body, this drug is thought to work||
3133|037|U|by affecting the body's natural defenses (immune system). This||
3133|038|U|effect slows or stops cancer cell growth.||
3133|039|B|||
3133|040|V|OTHER USES:  This section contains uses of this drug that are not||
3133|041|V|listed in the approved professional labeling for the drug but||
3133|042|V|that may be prescribed by your health care professional. Use this||
3133|043|V|drug for a condition that is listed in this section only if it||
3133|044|V|has been so prescribed by your health care professional.||
3133|045|V|   This drug may also be used for certain other types of cancer||
3133|046|V|(such as Kaposi's sarcoma, neuroblastoma).||
3133|047|B|||
3133|048|H|HOW TO USE:  This medication is given by injection into a vein||
3133|049|H|over 15 minutes by a health care professional. It may also be||
3133|050|H|given in other ways as directed by your doctor.||
3133|051|H|   This medication is usually given every 8 hours for 5 days in a||
3133|052|H|row. However, your doctor may decide to delay or stop your||
3133|053|H|treatment depending on how you respond to this drug. After this||
3133|054|H|treatment period, you will be given time to rest and recover||
3133|055|H|before getting more of this medication. A course of treatment may||
3133|056|H|include up to 28 doses of this medication. To make sure that you||
3133|057|H|receive each scheduled dose as directed, it is important to keep||
3133|058|H|all of your medical appointments while receiving this medication.||
3133|059|H|Depending on your response, your doctor may decide that a second||
3133|060|H|course would be helpful.||
3133|061|H|   Dosage is based on your medical condition, weight, response to||
3133|062|H|treatment, and your side effects.||
3133|063|B|||
3133|064|S|SIDE EFFECTS:  See also Warning section.||
3133|065|S|   Fever, chills, stomach upset, dry skin, muscle stiffness,||
3133|066|S|diarrhea, mouth sores, dizziness, drowsiness, headache, weight||
3133|067|S|gain, nausea, vomiting, and loss of appetite may occur. Nausea||
3133|068|S|and vomiting can be severe. In some cases, your doctor may||
3133|069|S|prescribe medication to prevent or relieve nausea and vomiting.||
3133|070|S|Eating several small meals, not eating before treatment, or||
3133|071|S|limiting activity may help lessen some of these effects. If these||
3133|072|S|effects last or get worse, tell your doctor or pharmacist||
3133|073|S|promptly.||
3133|074|S|   People using this medication may have serious side effects.||
3133|075|S|However, you have been prescribed this drug because your doctor||
3133|076|S|has judged that the benefit to you is greater than the risk of||
3133|077|S|side effects. Careful monitoring by your doctor may decrease your||
3133|078|S|risk.||
3133|079|S|   Tell your doctor right away if you have any serious side||
3133|080|S|effects, including: swollen belly, muscle pain/weakness,||
3133|081|S|difficulty speaking, trouble walking, vision changes (including||
3133|082|S|temporary blindness), mental/mood changes (such as confusion,||
3133|083|S|depression, agitation, hallucinations), unusual||
3133|084|S|bleeding/bruising, thirst, flushing, rapid breathing, fast||
3133|085|S|heartbeat, yellowing eyes/skin, dark urine, vomit that looks like||
3133|086|S|coffee grounds, symptoms of heart failure (such as shortness of||
3133|087|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
3133|088|S|weight gain).||
3133|089|S|   Get medical help right away if you have any very serious side||
3133|090|S|effects, including: chest/jaw/left arm pain, seizures.||
3133|091|S|   A very serious allergic reaction to this drug is rare.||
3133|092|S|However, get medical help right away if you notice any symptoms||
3133|093|S|of a serious allergic reaction, including: rash, itching/swelling||
3133|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3133|095|S|breathing.||
3133|096|S|   This is not a complete list of possible side effects. If you||
3133|097|S|notice other effects not listed above, contact your doctor or||
3133|098|S|pharmacist.||
3133|099|S|   In the US -||
3133|100|S|   Call your doctor for medical advice about side effects. You||
3133|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3133|102|S|www.fda.gov/medwatch.||
3133|103|S|   In Canada - Call your doctor for medical advice about side||
3133|104|S|effects. You may report side effects to Health Canada at||
3133|105|S|1-866-234-2345.||
3133|106|B|||
3133|107|P|PRECAUTIONS:  See also Warning section.||
3133|108|P|   Before using aldesleukin, tell your doctor or pharmacist if||
3133|109|P|you are allergic to it; or if you have any other allergies. This||
3133|110|P|product may contain inactive ingredients, which can cause||
3133|111|P|allergic reactions or other problems. Talk to your pharmacist for||
3133|112|P|more details.||
3133|113|P|   Before using this medication, tell your doctor or pharmacist||
3133|114|P|your medical history, especially of: kidney problems (such as||
3133|115|P|glomerulonephritis), heart disease (such as fast/irregular||
3133|116|P|heartbeat, recent heart attack, angina), liver disease, lung||
3133|117|P|disease, stomach/intestinal problems (such as Crohn's disease,||
3133|118|P|ischemic bowel, perforation, bleeding ulcers), high levels of||
3133|119|P|calcium (hypercalcemia), organ transplant, thyroid disorders, a||
3133|120|P|certain connective tissue disease (scleroderma), seizures,||
3133|121|P|arthritis, diabetes, gallbladder problems (cholecystitis), a||
3133|122|P|certain disease of blood vessels in the brain (cerebral||
3133|123|P|vasculitis), a certain muscle/nerve disease (myasthenia gravis).||
3133|124|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3133|125|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3133|126|P|machinery, or do anything that needs alertness until you can do||
3133|127|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
3133|128|P|are using marijuana (cannabis).||
3133|129|P|   If you are scheduled to have any X-ray or scanning procedure||
3133|130|P|using injectable dye (such as iodinated contrast), tell your||
3133|131|P|doctor that you are using this medication.||
3133|132|P|   Older adults may be at a greater risk for kidney effects or||
3133|133|P|shortness of breath while using this drug.||
3133|134|P|   Tell your doctor if you are pregnant or plan to become||
3133|135|P|pregnant. You should not become pregnant while using aldesleukin.||
3133|136|P|Aldesleukin may harm an unborn baby. Your doctor should order a||
3133|137|P|pregnancy test before you start this medication. Ask about||
3133|138|P|reliable forms of birth control while using this medication. If||
3133|139|P|you become pregnant, talk to your doctor right away about the||
3133|140|P|risks and benefits of this medication.||
3133|141|P|   It is unknown if this medication passes into breast milk.||
3133|142|P|Because of the possible risk to the infant, breastfeeding is not||
3133|143|P|recommended while using this medication. Consult your doctor||
3133|144|P|before breastfeeding.||
3133|145|B|||
3133|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3133|147|I|medications work or increase your risk for serious side effects.||
3133|148|I|This document does not contain all possible drug interactions.||
3133|149|I|Keep a list of all the products you use (including||
3133|150|I|prescription/nonprescription drugs and herbal products) and share||
3133|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
3133|152|I|the dosage of any medicines without your doctor's approval.||
3133|153|I|   Some products that may interact with this drug are: blood||
3133|154|I|pressure drugs (including beta blockers such as metoprolol),||
3133|155|I|corticosteroids (such as hydrocortisone, methylprednisolone,||
3133|156|I|prednisone), interferon alfa, tamoxifen, drugs that can cause||
3133|157|I|kidney problems (including indomethacin, aminoglycosides such as||
3133|158|I|gentamicin), other anti-cancer medication (such as asparaginase,||
3133|159|I|cisplatin, dacarbazine, methotrexate).||
3133|160|I|   Tell your doctor or pharmacist if you are taking other||
3133|161|I|products that cause drowsiness such as opioid pain or cough||
3133|162|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3133|163|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3133|164|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3133|165|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
3133|166|I|diphenhydramine).||
3133|167|I|   Check the labels on all your medicines (such as allergy or||
3133|168|I|cough-and-cold products) because they may contain ingredients||
3133|169|I|that cause drowsiness. Ask your pharmacist about using those||
3133|170|I|products safely.||
3133|171|B|||
3133|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3133|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3133|174|O|poison control center right away. US residents can call||
3133|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3133|176|B|||
3133|177|N|NOTES:  Because there may be breaks in treatment, it is important||
3133|178|N|to keep all medical/infusion appointments.||
3133|179|N|   Lab and/or medical tests (such as complete blood counts,||
3133|180|N|kidney/liver/lung function, chest X-ray, blood pressure, pulse,||
3133|181|N|mental status, weight, urine output) should also be done before||
3133|182|N|you start using this medication and while you are using it. Keep||
3133|183|N|all medical and lab appointments. Consult your doctor for more||
3133|184|N|details.||
3133|185|B|||
3133|186|D|MISSED DOSE:  It is important to get each dose of this medication||
3133|187|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
3133|188|D|right away for a new dosing schedule.||
3133|189|B|||
3133|190|R|STORAGE:  Not applicable. This medication is given in a hospital||
3133|191|R|and will not be stored at home.||
3133|192|B|||
3133|193|M|MEDICAL ALERT:  Your condition can cause complications in a||
3133|194|M|medical emergency. For information about enrolling in MedicAlert,||
3133|195|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3133|196|B|||
3133|197|A|Information last revised May 2025.||
3133|198|A|Copyright(c) 2025 First Databank, Inc.||
3133|199|B|||
3134|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3134|002|Z|does NOT have all possible information about this product. This||
3134|003|Z|information does not assure that this product is safe, effective,||
3134|004|Z|or appropriate for you. This information is not individual||
3134|005|Z|medical advice and does not substitute for the advice of your||
3134|006|Z|health care professional. Always ask your health care||
3134|007|Z|professional for complete information about this product and your||
3134|008|Z|specific health needs.||
3134|009|B|||
3134|010|T|IDARUBICIN - INJECTION||
3134|011|F|(eye-duh-REWB-eh-sin)||
3134|012|B|||
3134|013|C|COMMON BRAND NAME(S): Idamycin||
3134|014|B|||
3134|015|W|WARNING:  Idarubicin must be given only by injection slowly into||
3134|016|W|a vein. Do not give by injection into a muscle or under the skin.||
3134|017|W|If this medication accidentally leaks into the skin/muscle around||
3134|018|W|the injection site, it may cause severe damage. Tell your doctor||
3134|019|W|right away if you notice redness, pain, or swelling at or near||
3134|020|W|the injection site.||
3134|021|W|   This medication may rarely cause serious (rarely fatal) heart||
3134|022|W|problems (including heart failure). This may occur both during||
3134|023|W|treatment or after treatment is completed. The risk of heart||
3134|024|W|problems is affected by your dose, medical history (including||
3134|025|W|heart disease, radiation treatment to the chest area, current||
3134|026|W|infections, anemia), and previous use of this and other drugs||
3134|027|W|(including doxorubicin). Tell your doctor right away if you||
3134|028|W|notice symptoms such as irregular heartbeat, shortness of breath,||
3134|029|W|swelling ankles/feet, unusual tiredness, or unusual/sudden weight||
3134|030|W|gain.||
3134|031|W|   Idarubicin may cause certain severe blood and bone marrow||
3134|032|W|disorders (low red blood cells/white blood cells/platelets). This||
3134|033|W|can affect your body's ability to stop bleeding or fight||
3134|034|W|infection. Tell your doctor right away if you develop easy||
3134|035|W|bleeding/bruising or signs of infection (such as sore throat that||
3134|036|W|doesn't go away, fever, chills).||
3134|037|W|   Very rarely, people with cancer who are treated with this type||
3134|038|W|of medication have developed other cancers (such as secondary||
3134|039|W|leukemia). The risk may be increased when this medication is||
3134|040|W|given with certain anti-cancer drugs or radiation treatment.||
3134|041|W|Consult your doctor for more details.||
3134|042|W|   Before starting treatment with this medication, tell your||
3134|043|W|doctor if you have liver or kidney problems. Your dose may need||
3134|044|W|to be adjusted.||
3134|045|B|||
3134|046|U|USES:  Idarubicin is used to treat a certain type of cancer||
3134|047|U|(leukemia). It belongs to a class of drugs known as||
3134|048|U|anthracyclines and works by slowing or stopping the growth of||
3134|049|U|cancer cells.||
3134|050|B|||
3134|051|H|HOW TO USE:  This medication is given by injection into a vein by||
3134|052|H|a health care professional, as directed by your doctor. The||
3134|053|H|dosage is based on your medical condition, body size, and||
3134|054|H|response to treatment.||
3134|055|H|   If this medication touches your skin, immediately wash the||
3134|056|H|area well with soap and water. If this medication gets in your||
3134|057|H|eye, open the eyelids and flush with water for 15 minutes, then||
3134|058|H|get medical help right away.||
3134|059|H|   Drink plenty of fluids while using this medication unless||
3134|060|H|otherwise directed by your doctor. Doing so helps decrease the||
3134|061|H|risk of certain side effects (such as increased uric acid).||
3134|062|B|||
3134|063|S|SIDE EFFECTS:  See also Warning section.||
3134|064|S|   Nausea, vomiting, abdominal cramps, diarrhea, and headache may||
3134|065|S|occur. In some cases, your doctor may prescribe medication to||
3134|066|S|prevent or relieve nausea and vomiting. Eating several small||
3134|067|S|meals, not eating before treatment, or limiting activity may help||
3134|068|S|lessen some of these effects. If these effects last or get worse,||
3134|069|S|tell your doctor or pharmacist promptly.||
3134|070|S|   Temporary hair loss is a common side effect. Normal hair||
3134|071|S|growth should return after treatment has ended.||
3134|072|S|   Remember that this medication has been prescribed because your||
3134|073|S|doctor has judged that the benefit to you is greater than the||
3134|074|S|risk of side effects. Many people using this medication do not||
3134|075|S|have serious side effects.||
3134|076|S|   Tell your doctor right away if you have any serious side||
3134|077|S|effects, including: severe abdominal pain, mental/mood changes||
3134|078|S|(such as confusion), numbness/tingling of arms/legs,||
3134|079|S|rash/blisters on palms of hands/soles of feet, unusual||
3134|080|S|bleeding/bruising (such as small red spots on the skin,||
3134|081|S|black/bloody stools, bloody urine, vomit that looks like coffee||
3134|082|S|grounds).||
3134|083|S|   Pain or sores in the mouth and throat may occur. Brush your||
3134|084|S|teeth gently/carefully, avoid using mouthwash that contains||
3134|085|S|alcohol, and rinse your mouth often with cool water mixed with||
3134|086|S|baking soda or salt. It may also be best to eat soft, moist||
3134|087|S|foods.||
3134|088|S|   Get medical help right away if you have any very serious side||
3134|089|S|effects, including: seizure.||
3134|090|S|   A very serious allergic reaction to this drug is rare.||
3134|091|S|However, get medical help right away if you notice any symptoms||
3134|092|S|of a serious allergic reaction, including: rash, itching/swelling||
3134|093|S|(especially of the face/tongue/throat), trouble breathing, severe||
3134|094|S|dizziness.||
3134|095|S|   This is not a complete list of possible side effects. If you||
3134|096|S|notice other effects not listed above, contact your doctor or||
3134|097|S|pharmacist.||
3134|098|S|   In the US -||
3134|099|S|   Call your doctor for medical advice about side effects. You||
3134|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3134|101|S|www.fda.gov/medwatch.||
3134|102|S|   In Canada - Call your doctor for medical advice about side||
3134|103|S|effects. You may report side effects to Health Canada at||
3134|104|S|1-866-234-2345.||
3134|105|B|||
3134|106|P|PRECAUTIONS:  Before using idarubicin, tell your doctor or||
3134|107|P|pharmacist if you are allergic to it; or to other anthracyclines||
3134|108|P|(such as doxorubicin); or if you have any other allergies. This||
3134|109|P|product may contain inactive ingredients, which can cause||
3134|110|P|allergic reactions or other problems. Talk to your pharmacist for||
3134|111|P|more details.||
3134|112|P|   Before using this medication, tell your doctor or pharmacist||
3134|113|P|your medical history, especially of: blood/bleeding disorders||
3134|114|P|(such as anemia, low blood cell counts), gout, heart disease||
3134|115|P|(such as heart failure, irregular heartbeat), kidney disease,||
3134|116|P|liver disease, radiation treatment (especially to chest area).||
3134|117|P|   Idarubicin can make you more likely to get infections or may||
3134|118|P|make current infections worse. Stay away from anyone who has an||
3134|119|P|infection that may easily spread (such as chickenpox, COVID-19,||
3134|120|P|measles, flu). Talk to your doctor if you have been exposed to an||
3134|121|P|infection or for more details.||
3134|122|P|   Tell your health care professional that you are using||
3134|123|P|idarubicin before having any immunizations/vaccinations. Avoid||
3134|124|P|contact with people who have recently received live vaccines||
3134|125|P|(such as flu vaccine inhaled through the nose).||
3134|126|P|   To lower your risk of getting cut, bruised, or injured, use||
3134|127|P|caution with sharp objects like razors and nail cutters, and||
3134|128|P|avoid activities such as contact sports.||
3134|129|P|   Before having surgery, tell your doctor or dentist about all||
3134|130|P|the products you use (including prescription drugs,||
3134|131|P|nonprescription drugs, and herbal products).||
3134|132|P|   Older adults may be more sensitive to the side effects of this||
3134|133|P|drug, especially the effects on the heart.||
3134|134|P|   Tell your doctor if you are pregnant or plan to become||
3134|135|P|pregnant. You should not become pregnant while using idarubicin.||
3134|136|P|Idarubicin may harm an unborn baby. Women using this medication||
3134|137|P|should ask about reliable forms of birth control during treatment||
3134|138|P|and for at least six and a half months after the last dose. Men||
3134|139|P|using this medication should ask about reliable forms of birth||
3134|140|P|control during treatment and for at least three and a half months||
3134|141|P|after the last dose. If you or your partner becomes pregnant,||
3134|142|P|talk to your doctor right away about the risks and benefits of||
3134|143|P|this medication.||
3134|144|P|   It is unknown if this drug passes into breast milk. Because of||
3134|145|P|the possible risk to the infant, breastfeeding is not recommended||
3134|146|P|while using this drug and for 14 days after the last dose.||
3134|147|P|Consult your doctor before breastfeeding.||
3134|148|B|||
3134|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3134|150|I|medications work or increase your risk for serious side effects.||
3134|151|I|This document does not contain all possible drug interactions.||
3134|152|I|Keep a list of all the products you use (including||
3134|153|I|prescription/nonprescription drugs and herbal products) and share||
3134|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
3134|155|I|the dosage of any medicines without your doctor's approval.||
3134|156|I|   Some products that may interact with this drug include: other||
3134|157|I|drugs that may affect the heart (including trastuzumab,||
3134|158|I|anthracyclines such as doxorubicin).||
3134|159|B|||
3134|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3134|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3134|162|O|poison control center right away. US residents can call||
3134|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3134|164|O|Symptoms of overdose may include: irregular heartbeat, severe||
3134|165|O|nausea/vomiting.||
3134|166|B|||
3134|167|N|NOTES:  Lab and/or medical tests (such as kidney/liver/heart||
3134|168|N|function, complete blood count) should be done while you are||
3134|169|N|using this medication. Keep all medical and lab appointments.||
3134|170|N|Consult your doctor for more details.||
3134|171|B|||
3134|172|D|MISSED DOSE:  It is important to get each dose of this medication||
3134|173|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
3134|174|D|right away for a new dosing schedule.||
3134|175|B|||
3134|176|R|STORAGE:  Not applicable. This medication is given in a clinic||
3134|177|R|and will not be stored at home.||
3134|178|B|||
3134|179|M|MEDICAL ALERT:  Your condition can cause complications in a||
3134|180|M|medical emergency. For information about enrolling in MedicAlert,||
3134|181|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3134|182|B|||
3134|183|A|Information last revised November 2025.||
3134|184|A|Copyright(c) 2025 First Databank, Inc.||
3134|185|B|||
3135|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3135|002|Z|does NOT have all possible information about this product. This||
3135|003|Z|information does not assure that this product is safe, effective,||
3135|004|Z|or appropriate for you. This information is not individual||
3135|005|Z|medical advice and does not substitute for the advice of your||
3135|006|Z|health care professional. Always ask your health care||
3135|007|Z|professional for complete information about this product and your||
3135|008|Z|specific health needs.||
3135|009|B|||
3135|010|T|MELPHALAN - ORAL||
3135|011|F|(MEL-fa-lan)||
3135|012|B|||
3135|013|C|COMMON BRAND NAME(S): Alkeran||
3135|014|B|||
3135|015|W|WARNING:  Although melphalan is used to treat cancer, it may||
3135|016|W|rarely increase your risk of developing other cancers. Also,||
3135|017|W|melphalan may cause a severe decrease in your blood cells, which||
3135|018|W|lowers your ability to fight infections and increases the risk of||
3135|019|W|anemia/bleeding problems. You may be more likely to get a serious||
3135|020|W|(rarely fatal) infection or any infection you have may get worse.||
3135|021|W|Tell your doctor right away if you develop unusual growths or||
3135|022|W|lumps, swollen lymph nodes, signs of infection (such as sore||
3135|023|W|throat that doesn't go away, fever, chills), easy or unusual||
3135|024|W|bruising/bleeding, or unusual tiredness.||
3135|025|W|   Taking melphalan during pregnancy may increase the risk of||
3135|026|W|birth defects. Also, it may make it harder for men or women to||
3135|027|W|have a child (decreased fertility) after treatment.||
3135|028|W|   Talk with your doctor about the risks and benefits of||
3135|029|W|treatment with this medication.||
3135|030|B|||
3135|031|U|USES:  This medication is used to treat certain types of cancer||
3135|032|U|(such as multiple myeloma, ovarian). Melphalan belongs to a class||
3135|033|U|of drugs known as alkylating agents. It works by slowing or||
3135|034|U|stopping the growth of cancer cells.||
3135|035|B|||
3135|036|H|HOW TO USE:  Take this medication by mouth as directed by your||
3135|037|H|doctor, usually once a day. Unless otherwise directed by your||
3135|038|H|doctor, drink plenty of fluids to help prevent side effects.||
3135|039|H|   The dosage and treatment schedule are based on your medical||
3135|040|H|condition and response to treatment. Carefully follow your||
3135|041|H|doctor's directions for taking this medication.||
3135|042|H|   Do not increase your dose or take this medication more often||
3135|043|H|than prescribed. Your condition will not improve any faster, and||
3135|044|H|your risk of serious side effects will increase.||
3135|045|H|   It may take several months before you see a benefit from this||
3135|046|H|drug.||
3135|047|H|   Since this drug can be absorbed through the skin and lungs and||
3135|048|H|may harm an unborn baby, women who are pregnant or who may become||
3135|049|H|pregnant should not handle this medication or breathe the dust||
3135|050|H|from the tablets.||
3135|051|B|||
3135|052|S|SIDE EFFECTS:  See also Warning section.||
3135|053|S|   Nausea, vomiting, diarrhea, lip/mouth sores, and loss of||
3135|054|S|appetite may occur. Nausea and vomiting can be severe. In some||
3135|055|S|cases, your doctor may prescribe medication to prevent or relieve||
3135|056|S|nausea and vomiting. Eating several small meals, not eating||
3135|057|S|before treatment, or limiting activity may help lessen some of||
3135|058|S|these effects. If any of these effects last or get worse, tell||
3135|059|S|your doctor or pharmacist promptly.||
3135|060|S|   Temporary hair loss may occur. Normal hair growth should||
3135|061|S|return after treatment has ended.||
3135|062|S|   People using this medication may have serious side effects.||
3135|063|S|However, you have been prescribed this drug because your doctor||
3135|064|S|has judged that the benefit to you is greater than the risk of||
3135|065|S|side effects. Careful monitoring by your doctor may decrease your||
3135|066|S|risk.||
3135|067|S|   Tell your doctor right away if you have any serious side||
3135|068|S|effects, such as: shortness of breath, stopped menstrual periods||
3135|069|S|(women), symptoms of liver problems (such as stomach/abdominal||
3135|070|S|pain, yellowing eyes/skin, dark urine).||
3135|071|S|   A very serious allergic reaction to this drug is rare.||
3135|072|S|However, get medical help right away if you notice any symptoms||
3135|073|S|of a serious allergic reaction, such as: rash, itching/swelling||
3135|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3135|075|S|breathing.||
3135|076|S|   This is not a complete list of possible side effects. If you||
3135|077|S|notice other effects not listed above, contact your doctor or||
3135|078|S|pharmacist.||
3135|079|S|   In the US -||
3135|080|S|   Call your doctor for medical advice about side effects. You||
3135|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3135|082|S|www.fda.gov/medwatch.||
3135|083|S|   In Canada - Call your doctor for medical advice about side||
3135|084|S|effects. You may report side effects to Health Canada at||
3135|085|S|1-866-234-2345.||
3135|086|B|||
3135|087|P|PRECAUTIONS:  Before taking melphalan, tell your doctor or||
3135|088|P|pharmacist if you are allergic to it; or to chlorambucil; or if||
3135|089|P|you have any other allergies. This product may contain inactive||
3135|090|P|ingredients, which can cause allergic reactions or other||
3135|091|P|problems. Talk to your pharmacist for more details.||
3135|092|P|   Before using this medication, tell your doctor or pharmacist||
3135|093|P|your medical history, especially of: bleeding/blood problems,||
3135|094|P|kidney problems, radiation treatment.||
3135|095|P|   Melphalan can make you more likely to get infections or may||
3135|096|P|make current infections worse. Stay away from anyone who has an||
3135|097|P|infection that may easily spread (such as chickenpox, COVID-19,||
3135|098|P|measles, flu). Talk to your doctor if you have been exposed to an||
3135|099|P|infection or for more details.||
3135|100|P|   Tell your health care professional that you are using||
3135|101|P|melphalan before having any immunizations/vaccinations. Avoid||
3135|102|P|contact with people who have recently received live vaccines||
3135|103|P|(such as flu vaccine inhaled through the nose).||
3135|104|P|   To lower the chance of getting cut, bruised, or injured, use||
3135|105|P|caution with sharp objects like razors and nail cutters, and||
3135|106|P|avoid activities such as contact sports.||
3135|107|P|   Before having surgery, tell your doctor or dentist about all||
3135|108|P|the products you use (such as prescription drugs, nonprescription||
3135|109|P|drugs, and herbal products).||
3135|110|P|   Tell your doctor if you are pregnant or plan to become||
3135|111|P|pregnant. You should not become pregnant while you are using||
3135|112|P|melphalan. Melphalan may harm an unborn baby. If you become||
3135|113|P|pregnant, talk to your doctor right away about the risks and||
3135|114|P|benefits of this medication.||
3135|115|P|   Since this drug can be absorbed through the skin and lungs and||
3135|116|P|may harm an unborn baby, women who are pregnant or who may become||
3135|117|P|pregnant should not handle this medication or breathe the dust||
3135|118|P|from the tablets.||
3135|119|P|   It is unknown if this drug passes into breast milk. Because of||
3135|120|P|the possible risk to the infant, breastfeeding is not recommended||
3135|121|P|while using this drug. Consult your doctor before breastfeeding.||
3135|122|B|||
3135|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3135|124|I|medications work or increase your risk for serious side effects.||
3135|125|I|This document does not contain all possible drug interactions.||
3135|126|I|Keep a list of all the products you use (such as||
3135|127|I|prescription/nonprescription drugs and herbal products) and share||
3135|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
3135|129|I|the dosage of any medicines without your doctor's approval.||
3135|130|B|||
3135|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3135|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3135|133|O|poison control center right away. US residents can call||
3135|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3135|135|B|||
3135|136|N|NOTES:  Do not share this medication with others.||
3135|137|N|   Lab and/or medical tests (such as complete blood count, liver||
3135|138|N|function) should be done while you are taking this medication.||
3135|139|N|Keep all medical and lab appointments.||
3135|140|B|||
3135|141|D|MISSED DOSE:  It is important to get each dose of this medication||
3135|142|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
3135|143|D|right away for a new dosing schedule. Do not double the dose to||
3135|144|D|catch up.||
3135|145|B|||
3135|146|R|STORAGE:  Store in the refrigerator away from light and moisture.||
3135|147|R|Keep all medications away from children and pets.||
3135|148|R|   Do not flush medications down the toilet or pour them into a||
3135|149|R|drain unless instructed to do so. Properly discard this product||
3135|150|R|when it is expired or no longer needed. Consult your pharmacist||
3135|151|R|or local waste disposal company.||
3135|152|B|||
3135|153|M|MEDICAL ALERT:  Your condition can cause complications in a||
3135|154|M|medical emergency. For information about enrolling in MedicAlert,||
3135|155|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3135|156|B|||
3135|157|A|Information last revised May 2025.||
3135|158|A|Copyright(c) 2025 First Databank, Inc.||
3135|159|B|||
3143|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3143|002|Z|does NOT have all possible information about this product. This||
3143|003|Z|information does not assure that this product is safe, effective,||
3143|004|Z|or appropriate for you. This information is not individual||
3143|005|Z|medical advice and does not substitute for the advice of your||
3143|006|Z|health care professional. Always ask your health care||
3143|007|Z|professional for complete information about this product and your||
3143|008|Z|specific health needs.||
3143|009|B|||
3143|010|T|PANTOPRAZOLE - INJECTION||
3143|011|F|(pan-TOE-pra-zole)||
3143|012|B|||
3143|013|C|COMMON BRAND NAME(S): Protonix IV||
3143|014|B|||
3143|015|U|USES:  Pantoprazole is used to treat certain stomach and||
3143|016|U|esophagus problems (such as acid reflux). It works by decreasing||
3143|017|U|the amount of acid your stomach makes. This medication relieves||
3143|018|U|symptoms such as heartburn, difficulty swallowing, and cough. It||
3143|019|U|helps heal acid damage to the stomach and esophagus, helps||
3143|020|U|prevent ulcers, and may help prevent cancer of the esophagus.||
3143|021|U|Pantoprazole belongs to a class of drugs known as proton pump||
3143|022|U|inhibitors (PPIs).||
3143|023|U|   The injection form of this drug is used for a short time when||
3143|024|U|you cannot take the medication by mouth. When possible, your||
3143|025|U|doctor should switch you to the form that is taken by mouth.||
3143|026|B|||
3143|027|H|HOW TO USE:  This medication is given by injection into a vein as||
3143|028|H|directed by your doctor. The dosage and length of treatment are||
3143|029|H|based on your medical condition and response to treatment.||
3143|030|H|Children's dosage is also based on weight.||
3143|031|H|   If you are using this medication at home, learn all||
3143|032|H|preparation and usage instructions from your health care||
3143|033|H|professional. Before using, check this product for particles or||
3143|034|H|discoloration. If either is present, do not use the liquid. Learn||
3143|035|H|how to store and discard medical supplies safely.||
3143|036|H|   If you are using the frozen mixed liquid, thaw the medication||
3143|037|H|at room temperature or in the refrigerator before using. Do not||
3143|038|H|thaw by putting in a water bath or microwave. After thawing,||
3143|039|H|squeeze the container to check for leaks. Discard the solution if||
3143|040|H|the container leaks. Do not freeze it again after thawing.||
3143|041|H|   Tell your doctor if your condition lasts or gets worse. The||
3143|042|H|risk of side effects goes up over time. Ask your doctor how long||
3143|043|H|you should use this medication.||
3143|044|B|||
3143|045|S|SIDE EFFECTS:  Headache or diarrhea may occur. Redness, pain, or||
3143|046|S|swelling at the injection site may also occur. If any of these||
3143|047|S|effects last or get worse, tell your doctor or pharmacist||
3143|048|S|promptly.||
3143|049|S|   Remember that this medication has been prescribed because your||
3143|050|S|doctor has judged that the benefit to you is greater than the||
3143|051|S|risk of side effects. Many people using this medication do not||
3143|052|S|have serious side effects.||
3143|053|S|   Tell your doctor right away if you have any serious side||
3143|054|S|effects, including: symptoms of a low magnesium blood level (such||
3143|055|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
3143|056|S|(such as rash on nose and cheeks, new or worsening joint pain),||
3143|057|S|signs of kidney problems (such as change in the amount of urine,||
3143|058|S|pink/bloody urine).||
3143|059|S|   This medication may rarely cause a severe intestinal condition||
3143|060|S|due to a bacteria called C. difficile. This condition may occur||
3143|061|S|during treatment or weeks to months after treatment has stopped.||
3143|062|S|Tell your doctor right away if you develop: diarrhea that doesn't||
3143|063|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
3143|064|S|stool.||
3143|065|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
3143|066|S|products because they may make symptoms worse.||
3143|067|S|   A very serious allergic reaction to this drug is rare.||
3143|068|S|However, get medical help right away if you notice any symptoms||
3143|069|S|of a serious allergic reaction, including: fever, swollen lymph||
3143|070|S|nodes, rash, itching/swelling (especially of the||
3143|071|S|face/tongue/throat), severe dizziness, trouble breathing.||
3143|072|S|   This is not a complete list of possible side effects. If you||
3143|073|S|notice other effects not listed above, contact your doctor or||
3143|074|S|pharmacist.||
3143|075|S|   In the US -||
3143|076|S|   Call your doctor for medical advice about side effects. You||
3143|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3143|078|S|www.fda.gov/medwatch.||
3143|079|S|   In Canada - Call your doctor for medical advice about side||
3143|080|S|effects. You may report side effects to Health Canada at||
3143|081|S|1-866-234-2345.||
3143|082|B|||
3143|083|P|PRECAUTIONS:  Before using pantoprazole, tell your doctor or||
3143|084|P|pharmacist if you are allergic to it; or to similar drugs (such||
3143|085|P|as lansoprazole, omeprazole); or if you have any other allergies.||
3143|086|P|This product may contain inactive ingredients, which can cause||
3143|087|P|allergic reactions or other problems. Talk to your pharmacist for||
3143|088|P|more details.||
3143|089|P|   Before using this medication, tell your doctor or pharmacist||
3143|090|P|your medical history, especially of: liver disease, a lack of||
3143|091|P|certain minerals in the body (such as zinc), lupus.||
3143|092|P|   Some symptoms may actually be signs of a more serious||
3143|093|P|condition. Get medical help right away if you have: heartburn||
3143|094|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
3143|095|P|pain (especially with shortness of breath, unusual sweating),||
3143|096|P|unexplained weight loss.||
3143|097|P|   Before having surgery, tell your doctor or dentist about all||
3143|098|P|the products you use (including prescription drugs,||
3143|099|P|nonprescription drugs, and herbal products).||
3143|100|P|   Proton pump inhibitors (such as pantoprazole) may increase||
3143|101|P|your risk of bone fractures, especially with longer use, higher||
3143|102|P|doses, and in older adults. Talk with your doctor about ways to||
3143|103|P|prevent bone loss/fracture, such as by taking calcium (such as||
3143|104|P|calcium citrate) and vitamin D supplements.||
3143|105|P|   Older adults may be more sensitive to the side effects of this||
3143|106|P|drug, especially bone loss and fractures (see above), and C.||
3143|107|P|difficile infection (see Side Effects section).||
3143|108|P|   During pregnancy, this medication should be used only when||
3143|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
3143|110|P|   This medication passes into breast milk. Consult your doctor||
3143|111|P|before breastfeeding.||
3143|112|B|||
3143|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3143|114|I|medications work or increase your risk for serious side effects.||
3143|115|I|This document does not contain all possible drug interactions.||
3143|116|I|Keep a list of all the products you use (including||
3143|117|I|prescription/nonprescription drugs and herbal products) and share||
3143|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
3143|119|I|the dosage of any medicines without your doctor's approval.||
3143|120|I|   A product that may interact with this drug is: methotrexate||
3143|121|I|(especially high-dose treatment).||
3143|122|I|   Some products need stomach acid so that the body can absorb||
3143|123|I|them properly. Pantoprazole decreases stomach acid, so it may||
3143|124|I|change how well these products work. Some affected products||
3143|125|I|include ampicillin, atazanavir, erlotinib, levoketoconazole,||
3143|126|I|nelfinavir, pazopanib, rilpivirine, sparsentan, certain azole||
3143|127|I|antifungals (itraconazole, ketoconazole, posaconazole), among||
3143|128|I|others.||
3143|129|I|   This medication may interfere with certain lab tests (such as||
3143|130|I|urine test for tetrahydrocannabinol-THC, blood test to find||
3143|131|I|certain tumors), possibly causing false test results. Make sure||
3143|132|I|lab personnel and all your doctors know you use this drug.||
3143|133|B|||
3143|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3143|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3143|136|O|poison control center right away. US residents can call||
3143|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3143|138|B|||
3143|139|N|NOTES:  Do not share this medication with others.||
3143|140|N|   Lab and/or medical tests (such as a magnesium blood test) may||
3143|141|N|be done while you are using this medication. Keep all medical and||
3143|142|N|lab appointments. Consult your doctor for more details.||
3143|143|B|||
3143|144|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3143|145|D|If it is near the time of the next dose, skip the missed dose.||
3143|146|D|Use your next dose at the regular time. Do not double the dose to||
3143|147|D|catch up.||
3143|148|B|||
3143|149|R|STORAGE:  Different brands of this medication have different||
3143|150|R|storage needs. Check the product package for instructions on how||
3143|151|R|to store your brand, or ask your pharmacist. Keep all medications||
3143|152|R|away from children and pets.||
3143|153|R|   Do not flush medications down the toilet or pour them into a||
3143|154|R|drain unless instructed to do so. Properly discard this product||
3143|155|R|when it is expired or no longer needed. Consult your pharmacist||
3143|156|R|or local waste disposal company.||
3143|157|B|||
3143|158|A|Information last revised November 2024.||
3143|159|A|Copyright(c) 2025 First Databank, Inc.||
3143|160|B|||
3156|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3156|002|Z|does NOT have all possible information about this product. This||
3156|003|Z|information does not assure that this product is safe, effective,||
3156|004|Z|or appropriate for you. This information is not individual||
3156|005|Z|medical advice and does not substitute for the advice of your||
3156|006|Z|health care professional. Always ask your health care||
3156|007|Z|professional for complete information about this product and your||
3156|008|Z|specific health needs.||
3156|009|B|||
3156|010|T|SODIUM FLUORIDE 0.2% RINSE - DENTAL||
3156|011|F|(SO-dee-um FLOOR-ide)||
3156|012|B|||
3156|013|C|COMMON BRAND NAME(S): Nafrinse, Prevident||
3156|014|B|||
3156|015|U|USES:  This medication is applied to teeth to prevent cavities.||
3156|016|U|Fluoride is a mineral that works by making the teeth stronger and||
3156|017|U|more resistant to decay caused by acid and bacteria.||
3156|018|U|   Do not use this medication in children younger than 6 years||
3156|019|U|unless directed to do so by your doctor/dentist.||
3156|020|B|||
3156|021|H|HOW TO USE:  Use this rinse as directed by your dentist/doctor,||
3156|022|H|usually once weekly (at bedtime). After brushing your teeth,||
3156|023|H|place 2 teaspoonfuls (10 milliliters) of the solution into your||
3156|024|H|mouth, swish vigorously for 1 minute, and spit it out. Do not||
3156|025|H|swallow the medication.||
3156|026|H|   Carefully watch children during use and teach proper rinsing||
3156|027|H|habits to avoid swallowing.||
3156|028|H|   To get the most benefit, you should not eat, drink, or rinse||
3156|029|H|your mouth for at least 30 minutes after using the solution.||
3156|030|H|   Dosage is based on age and the amount of fluoride in your||
3156|031|H|drinking water. Do not exceed the recommended dose without||
3156|032|H|checking with your dentist/doctor. Doing so will not do more to||
3156|033|H|prevent cavities but may lead to side effects instead.||
3156|034|H|   Use this medication regularly to get the most benefit from it.||
3156|035|H|To help you remember, use it on the same day each week. Mark your||
3156|036|H|calendar with a reminder.||
3156|037|H|   Do not treat this medication like a normal mouthwash: do not||
3156|038|H|use it more often than prescribed, or just to freshen your||
3156|039|H|breath.||
3156|040|B|||
3156|041|S|SIDE EFFECTS:  Tell your dentist/doctor right away if you notice||
3156|042|S|any changes in the color or appearance of your teeth. These||
3156|043|S|effects may be a result of too much fluoride.||
3156|044|S|   Remember that this medication has been prescribed because your||
3156|045|S|doctor or dentist has judged that the benefit to you is greater||
3156|046|S|than the risk of side effects. Many people using this medication||
3156|047|S|do not have serious side effects.||
3156|048|S|   A very serious allergic reaction to this drug is rare.||
3156|049|S|However, get medical help right away if you notice any symptoms||
3156|050|S|of a serious allergic reaction, including: rash, itching/swelling||
3156|051|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3156|052|S|breathing.||
3156|053|S|   This is not a complete list of possible side effects. If you||
3156|054|S|notice other effects not listed above, contact your||
3156|055|S|dentist/doctor or pharmacist.||
3156|056|S|   In the US -||
3156|057|S|   Call your doctor for medical advice about side effects. You||
3156|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3156|059|S|www.fda.gov/medwatch.||
3156|060|S|   In Canada - Call your doctor for medical advice about side||
3156|061|S|effects. You may report side effects to Health Canada at||
3156|062|S|1-866-234-2345.||
3156|063|B|||
3156|064|P|PRECAUTIONS:  Before using sodium fluoride, tell your doctor or||
3156|065|P|pharmacist if you are allergic to it; or if you have any other||
3156|066|P|allergies. This product may contain inactive ingredients, which||
3156|067|P|can cause allergic reactions or other problems. Talk to your||
3156|068|P|pharmacist for more details.||
3156|069|P|   Before using this medication, tell your doctor or pharmacist||
3156|070|P|your medical history, especially of: mouth problems (such as||
3156|071|P|sores, mucositis), swallowing problems (dysphagia).||
3156|072|P|   Children may be more sensitive to the side effects of this||
3156|073|P|drug, especially if they swallow this medication.||
3156|074|P|   Tell your doctor if you are pregnant before using this||
3156|075|P|medication.||
3156|076|P|   This medication passes into breast milk. Consult your doctor||
3156|077|P|before breastfeeding.||
3156|078|B|||
3156|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3156|080|I|medications work or increase your risk for serious side effects.||
3156|081|I|This document does not contain all possible drug interactions.||
3156|082|I|Keep a list of all the products you use (including||
3156|083|I|prescription/nonprescription drugs and herbal products) and share||
3156|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
3156|085|I|the dosage of any medicines without your doctor's approval.||
3156|086|B|||
3156|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3156|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3156|089|O|poison control center right away. US residents can call||
3156|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3156|091|O|Symptoms of overdose may include: burning in the mouth, sore||
3156|092|O|tongue, nausea, vomiting, diarrhea, increased saliva, stomach||
3156|093|O|pain/cramping, muscle weakness, shaking, seizures.||
3156|094|B|||
3156|095|N|NOTES:  Do not share this medication with others.||
3156|096|N|   Using this medication does not replace good dental habits.||
3156|097|N|Continue to brush and floss your teeth regularly as directed by||
3156|098|N|your dentist, and have regular dental checkups.||
3156|099|B|||
3156|100|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3156|101|D|If it is near the time of the next dose, skip the missed dose.||
3156|102|D|Use your next dose at the regular time. Do not double the dose to||
3156|103|D|catch up.||
3156|104|B|||
3156|105|R|STORAGE:  Store at room temperature. Keep all medications away||
3156|106|R|from children and pets.||
3156|107|R|   Do not flush medications down the toilet or pour them into a||
3156|108|R|drain unless instructed to do so. Properly discard this product||
3156|109|R|when it is expired or no longer needed. Consult your pharmacist||
3156|110|R|or local waste disposal company.||
3156|111|B|||
3156|112|A|Information last revised October 2024.||
3156|113|A|Copyright(c) 2025 First Databank, Inc.||
3156|114|B|||
3157|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3157|002|Z|does NOT have all possible information about this product. This||
3157|003|Z|information does not assure that this product is safe, effective,||
3157|004|Z|or appropriate for you. This information is not individual||
3157|005|Z|medical advice and does not substitute for the advice of your||
3157|006|Z|health care professional. Always ask your health care||
3157|007|Z|professional for complete information about this product and your||
3157|008|Z|specific health needs.||
3157|009|B|||
3157|010|T|IMMUNE GLOBULIN - INJECTION||
3157|011|F|(ih-MYOON GLOB-you-lin)||
3157|012|B|||
3157|013|C|COMMON BRAND NAME(S): Alyglo, Gamimune N, Gammagard, Gammar,||
3157|014|C|Octagam, Sandoglobulin||
3157|015|B|||
3157|016|W|WARNING:  This medication may cause serious (rarely fatal) kidney||
3157|017|W|problems. The risk is higher if you have kidney problems,||
3157|018|W|diabetes, a serious blood infection (sepsis), a certain blood||
3157|019|W|problem (paraproteinemia), or a severe loss of body fluids||
3157|020|W|(dehydration), as well as if you are older than 65 years or are||
3157|021|W|taking other drugs that may harm the kidneys (such as||
3157|022|W|gentamicin).||
3157|023|W|   This medication may also rarely cause serious problems from||
3157|024|W|blood clots (such as heart attack, stroke, blood clots in the||
3157|025|W|lungs or legs). You may be at increased risk for blood clots if||
3157|026|W|you are an older adult, are severely dehydrated, have a catheter||
3157|027|W|in a vein close to your heart for giving medications, or have a||
3157|028|W|history of blood clots, heart/blood vessel disease, heart||
3157|029|W|failure, stroke, or if you are immobile (such as very long plane||
3157|030|W|flights or bedridden). If you use estrogen-containing products,||
3157|031|W|these may also increase your risk.||
3157|032|W|   Before using this medication, discuss the risks and benefits||
3157|033|W|and if you have any of these conditions, report them to your||
3157|034|W|doctor or pharmacist. The risk of kidney problems and blood clots||
3157|035|W|may be decreased by infusing this medication more slowly or by||
3157|036|W|using a less concentrated form of this medication if available.||
3157|037|W|Being adequately hydrated before receiving this medication may||
3157|038|W|also help reduce these risks.||
3157|039|W|   Get medical help right away if any of these side effects||
3157|040|W|occur: sudden weight gain, swelling of the hands/ankles/feet, a||
3157|041|W|change in the amount/color of urine, foamy/frothy urine,||
3157|042|W|shortness of breath/rapid breathing, chest/jaw/left arm pain,||
3157|043|W|unusual sweating, sudden dizziness/fainting, pain/swelling/warmth||
3157|044|W|in the arm/leg, sudden/severe headache, trouble speaking,||
3157|045|W|weakness on one side of the body, sudden vision changes, or||
3157|046|W|confusion.||
3157|047|B|||
3157|048|U|USES:  This medication is used to strengthen the body's natural||
3157|049|U|defense system (immune system) to lower the risk of infection in||
3157|050|U|persons with a weakened immune system. This medication is made||
3157|051|U|from healthy human blood that has a high level of certain||
3157|052|U|defensive substances (antibodies), which help fight infections.||
3157|053|U|It is also used to increase the blood count (platelets) in||
3157|054|U|persons with a certain blood disorder (idiopathic||
3157|055|U|thrombocytopenia purpura-ITP). Platelets are needed to stop||
3157|056|U|bleeding and form blood clots.||
3157|057|U|   Some immune globulin products may also be used to treat||
3157|058|U|certain types of muscle weakness problem (multifocal motor||
3157|059|U|neuropathy, dermatomyositis) or a certain nerve disorder (chronic||
3157|060|U|inflammatory demyelinating polyneuropathy-CIDP). Some products||
3157|061|U|may also be used to prevent certain blood vessel disorders in||
3157|062|U|people with Kawasaki syndrome.||
3157|063|B|||
3157|064|H|HOW TO USE:  This medication is given by injection slowly into a||
3157|065|H|vein as directed by your doctor.||
3157|066|H|   Your health care professional will start the medication slowly||
3157|067|H|while monitoring you closely. If you have few or no side effects,||
3157|068|H|the medication will be given faster. Tell your health care||
3157|069|H|professional right away if you experience any side effects such||
3157|070|H|as flushing, chills, muscle cramps, back/joint pain, fever,||
3157|071|H|nausea, vomiting, or shortness of breath. The infusion may need||
3157|072|H|to be stopped or given more slowly.||
3157|073|H|   The dosage and frequency depends on your medical condition,||
3157|074|H|weight, and response to treatment.||
3157|075|H|   If you are giving this medication to yourself at home, learn||
3157|076|H|all preparation and usage instructions from your health care||
3157|077|H|professional. Before using, check this product for particles or||
3157|078|H|discoloration. If either is present, do not use the liquid. Learn||
3157|079|H|how to store and discard medical supplies safely.||
3157|080|H|   Use this medication regularly in order to get the most benefit||
3157|081|H|from it. Keep all your medical/lab appointments.||
3157|082|B|||
3157|083|S|SIDE EFFECTS:  See also Warning section.||
3157|084|S|   Flushing, headache, dizziness, chills, muscle cramps,||
3157|085|S|back/joint pain, fever, nausea, or vomiting may occur. Tell your||
3157|086|S|doctor or other health care professional right away if any of||
3157|087|S|these effects occur, last, or get worse. Pain, redness, and||
3157|088|S|swelling at the injection site may also occur. If these effects||
3157|089|S|continue or become bothersome, tell your doctor.||
3157|090|S|   Remember that this medication has been prescribed because your||
3157|091|S|doctor has judged that the benefit to you is greater than the||
3157|092|S|risk of side effects. Many people using this medication do not||
3157|093|S|have serious side effects.||
3157|094|S|   This medication may raise your blood pressure. Check your||
3157|095|S|blood pressure regularly and tell your doctor if the results are||
3157|096|S|high.||
3157|097|S|   Tell your doctor right away if you have any serious side||
3157|098|S|effects, including: easy bleeding/bruising, fainting,||
3157|099|S|fast/irregular heartbeat, unusual tiredness.||
3157|100|S|   Treatment with this medication may rarely cause a serious||
3157|101|S|inflammation of the brain (aseptic meningitis syndrome) several||
3157|102|S|hours to 2 days after your treatment. Get medical help right away||
3157|103|S|if you develop severe headache, stiff neck, drowsiness, high||
3157|104|S|fever, sensitivity to light, eye pain, or severe nausea/vomiting.||
3157|105|S|   Lung problems may rarely occur 1 to 6 hours after your||
3157|106|S|treatment. You will be monitored closely for any lung problems||
3157|107|S|after your treatment.||
3157|108|S|   A very serious allergic reaction to this drug is rare.||
3157|109|S|However, get medical help right away if you notice any symptoms||
3157|110|S|of a serious allergic reaction, including: rash, itching/swelling||
3157|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3157|112|S|breathing.||
3157|113|S|   This is not a complete list of possible side effects. If you||
3157|114|S|notice other effects not listed above, contact your doctor or||
3157|115|S|pharmacist.||
3157|116|S|   In the US -||
3157|117|S|   Call your doctor for medical advice about side effects. You||
3157|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3157|119|S|www.fda.gov/medwatch.||
3157|120|S|   In Canada - Call your doctor for medical advice about side||
3157|121|S|effects. You may report side effects to Health Canada at||
3157|122|S|1-866-234-2345.||
3157|123|B|||
3157|124|P|PRECAUTIONS:  See also Warning section.||
3157|125|P|   Before using this medication, tell your doctor or pharmacist||
3157|126|P|if you are allergic to it; or to other immunoglobulin products||
3157|127|P|(such as CMV IgG); or if you have any other allergies. This||
3157|128|P|product may contain inactive ingredients, which can cause||
3157|129|P|allergic reactions or other problems. Talk to your pharmacist for||
3157|130|P|more details.||
3157|131|P|   Before using this medication, tell your doctor or pharmacist||
3157|132|P|your medical history, especially of: certain immune system||
3157|133|P|problems (immunoglobulin A deficiency, monoclonal gammopathies),||
3157|134|P|diabetes, high blood pressure, high blood fats (triglycerides),||
3157|135|P|migraines, current blood infection (sepsis), kidney disease,||
3157|136|P|severe loss of body fluids (dehydration).||
3157|137|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3157|138|P|can make you more dizzy. Do not drive, use machinery, or do||
3157|139|P|anything that needs alertness until you can do it safely. Limit||
3157|140|P|alcoholic beverages. Talk to your doctor if you are using||
3157|141|P|marijuana (cannabis).||
3157|142|P|   Some immune globulin products should not be used in people who||
3157|143|P|have a certain metabolic hereditary problem (such as||
3157|144|P|fructose/sucrose intolerance). Ask your doctor for more details.||
3157|145|P|   Some immune globulin products are made with maltose. This||
3157|146|P|substance can cause false high blood sugar levels when your blood||
3157|147|P|sugar is normal or even low. If you have diabetes, check with||
3157|148|P|your pharmacist whether the product you are using contains||
3157|149|P|maltose and whether your blood sugar testing supplies will work||
3157|150|P|with this product. Rarely, serious problems have occurred when||
3157|151|P|too much insulin was given because of false high sugar readings||
3157|152|P|or when low blood sugar went untreated.||
3157|153|P|   Tell your doctor of any recent or planned||
3157|154|P|immunizations/vaccinations. This medication may prevent a good||
3157|155|P|response to certain live viral vaccines (such as measles, mumps,||
3157|156|P|rubella, varicella). If you have recently received any of these||
3157|157|P|vaccines, your doctor may have you tested for a response or have||
3157|158|P|you vaccinated again later. If you plan on getting any of these||
3157|159|P|vaccines, your doctor will instruct you about the best time to||
3157|160|P|receive them so you get a good response.||
3157|161|P|   This medication is made from human blood. Even though the||
3157|162|P|blood is carefully tested, and this medication goes through a||
3157|163|P|special manufacturing process, there is an extremely small chance||
3157|164|P|that you may get infections from the medication (such as||
3157|165|P|hepatitis, Creutzfeldt-Jakob disease-CJD). Consult your doctor or||
3157|166|P|pharmacist for more information.||
3157|167|P|   Before having surgery, tell your doctor or dentist about all||
3157|168|P|the products you use (including prescription drugs,||
3157|169|P|nonprescription drugs, and herbal products).||
3157|170|P|   Older adults may be more sensitive to the side effects of the||
3157|171|P|drug, especially the effects on the kidneys.||
3157|172|P|   During pregnancy, this medication should be used only when||
3157|173|P|clearly needed. Discuss the risks and benefits with your doctor.||
3157|174|P|   It is unknown if this drug passes into breast milk. Consult||
3157|175|P|your doctor before breastfeeding.||
3157|176|B|||
3157|177|I|DRUG INTERACTIONS:  See also Warning section.||
3157|178|I|   Drug interactions may change how your medications work or||
3157|179|I|increase your risk for serious side effects. This document does||
3157|180|I|not contain all possible drug interactions. Keep a list of all||
3157|181|I|the products you use (including prescription/nonprescription||
3157|182|I|drugs and herbal products) and share it with your doctor and||
3157|183|I|pharmacist. Do not start, stop, or change the dosage of any||
3157|184|I|medicines without your doctor's approval.||
3157|185|I|   This medication may interfere with certain lab tests (such as||
3157|186|I|certain blood sugar tests, blood type, Coombs test), possibly||
3157|187|I|causing false test results. The blood sugar interference can lead||
3157|188|I|to serious (possibly fatal) consequences. Make sure lab personnel||
3157|189|I|and all your doctors and pharmacists know you use this drug, and||
3157|190|I|which type of blood sugar testing strips you use.||
3157|191|B|||
3157|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3157|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3157|194|O|poison control center right away. US residents can call||
3157|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3157|196|B|||
3157|197|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
3157|198|N|kidney/liver function, urine volume, blood pressure) should be||
3157|199|N|done before you start using this medication and while you are||
3157|200|N|using it. Keep all medical and lab appointments. Consult your||
3157|201|N|doctor for more details.||
3157|202|B|||
3157|203|D|MISSED DOSE:  It is important to get each dose of this medication||
3157|204|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
3157|205|D|right away for a new dosing schedule. Do not double the dose to||
3157|206|D|catch up.||
3157|207|B|||
3157|208|R|STORAGE:  Consult the product instructions and your pharmacist||
3157|209|R|for storage details. Keep all medications away from children and||
3157|210|R|pets.||
3157|211|R|   Do not flush medications down the toilet or pour them into a||
3157|212|R|drain unless instructed to do so. Properly discard this product||
3157|213|R|when it is expired or no longer needed. Consult your pharmacist||
3157|214|R|or local waste disposal company.||
3157|215|B|||
3157|216|A|Information last revised June 2025.||
3157|217|A|Copyright(c) 2025 First Databank, Inc.||
3157|218|B|||
3169|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3169|002|Z|does NOT have all possible information about this product. This||
3169|003|Z|information does not assure that this product is safe, effective,||
3169|004|Z|or appropriate for you. This information is not individual||
3169|005|Z|medical advice and does not substitute for the advice of your||
3169|006|Z|health care professional. Always ask your health care||
3169|007|Z|professional for complete information about this product and your||
3169|008|Z|specific health needs.||
3169|009|B|||
3169|010|T|VARICELLA VIRUS VACCINE (CHICKENPOX) - INJECTION||
3169|011|F|(VAR-i-SEL-a)||
3169|012|B|||
3169|013|C|COMMON BRAND NAME(S): Varivax||
3169|014|B|||
3169|015|U|USES:  This vaccine is used to help prevent varicella (also known||
3169|016|U|as chickenpox). Chickenpox is an infection that is usually mild,||
3169|017|U|but can sometimes lead to serious problems (such as brain/lung||
3169|018|U|problems, severe infections). Vaccination is the best way to||
3169|019|U|protect against this infection. It can help prevent the infection||
3169|020|U|or decrease the seriousness of the illness if you become||
3169|021|U|infected. This vaccine contains live viruses that have been||
3169|022|U|weakened. It works by increasing the body's natural defense||
3169|023|U|(immunity) against the viruses.||
3169|024|U|   The vaccine is recommended for children 12 months and older||
3169|025|U|and adults who have not had chickenpox or received a varicella||
3169|026|U|vaccination before.||
3169|027|U|   Vaccines may not fully protect everyone who receives them.||
3169|028|B|||
3169|029|H|HOW TO USE:  Read all vaccine information available from your||
3169|030|H|health care professional before receiving the vaccine. If you||
3169|031|H|have any questions, ask your health care professional.||
3169|032|H|   This vaccine is given by injection by a health care||
3169|033|H|professional. Depending on the brand, it may be given either||
3169|034|H|under the skin or into the muscle of the upper arm.||
3169|035|H|   Vaccines are usually given in a series of doses to provide the||
3169|036|H|best protection. Closely follow the vaccination schedule provided||
3169|037|H|by your health care professional. To help you remember, mark your||
3169|038|H|calendar with a reminder.||
3169|039|H|   This vaccine may be given at the same time as other vaccines.||
3169|040|B|||
3169|041|S|SIDE EFFECTS:  Pain/redness/bruising/swelling at the injection||
3169|042|S|site, fever, or mild chickenpox-like rash may occur. If any of||
3169|043|S|these effects last or get worse, tell your health care||
3169|044|S|professional promptly.||
3169|045|S|   Rarely, some people have symptoms such as fainting, dizziness,||
3169|046|S|vision changes, or ringing in the ears just after getting a||
3169|047|S|vaccine injection. Tell your health care professional right away||
3169|048|S|if you have any of these symptoms. Sitting or lying down may||
3169|049|S|help, since these symptoms usually don't last long.||
3169|050|S|   Remember that this vaccine has been prescribed because your||
3169|051|S|health care professional has judged that the benefit to you is||
3169|052|S|greater than the risk of side effects. Many people using this||
3169|053|S|vaccine do not have serious side effects.||
3169|054|S|   A very serious allergic reaction to this vaccine is rare.||
3169|055|S|However, get medical help right away if you notice any symptoms||
3169|056|S|of a serious allergic reaction, including: rash, itching/swelling||
3169|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3169|058|S|breathing.||
3169|059|S|   This is not a complete list of possible side effects. If you||
3169|060|S|notice other effects not listed above, contact your health care||
3169|061|S|professional.||
3169|062|S|   Contact the health care professional for medical advice about||
3169|063|S|side effects. The following numbers do not provide medical||
3169|064|S|advice, but in the US you may report side effects to the Vaccine||
3169|065|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
3169|066|S|Canada, you may call the Vaccine Safety Section at Public Health||
3169|067|S|Agency of Canada at 1-866-844-0018.||
3169|068|B|||
3169|069|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
3169|070|P|care professional if you are allergic to it; or if you have any||
3169|071|P|other allergies. This product may contain inactive ingredients||
3169|072|P|(such as neomycin, gelatin), which can cause allergic reactions||
3169|073|P|or other problems. Talk to your health care professional for more||
3169|074|P|details.||
3169|075|P|   Before receiving this vaccine, tell your health care||
3169|076|P|professional your medical history, especially of: current||
3169|077|P|fever/illness (such as tuberculosis), immune system disorders||
3169|078|P|(such as due to HIV infection, certain cancers such as||
3169|079|P|leukemia/lymphoma, cancer or radiation treatment), blood/plasma||
3169|080|P|transfusions, vaccination history (including previous reactions||
3169|081|P|to any vaccines).||
3169|082|P|   There is a small risk that you may expose others to infection||
3169|083|P|with chickenpox for up to 6 weeks after you have been vaccinated.||
3169|084|P|If you develop a rash after getting the vaccine, you should avoid||
3169|085|P|being in the same room with newborn babies (especially if born||
3169|086|P|prematurely), pregnant women who have not had chickenpox, and||
3169|087|P|people with immune system problems until the rash has dried and||
3169|088|P|crusted over.||
3169|089|P|   Tell your health care professional if you are pregnant or plan||
3169|090|P|to become pregnant. This vaccine should not be given if you are||
3169|091|P|pregnant. It may harm an unborn baby. Avoid getting pregnant for||
3169|092|P|3 months after receiving this vaccine. Talk to your health care||
3169|093|P|professional for details.||
3169|094|P|   It is unknown if the varicella vaccine virus passes into||
3169|095|P|breast milk. Consult your health care professional before||
3169|096|P|breastfeeding.||
3169|097|B|||
3169|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3169|099|I|medications work or increase your risk for serious side effects.||
3169|100|I|This document does not contain all possible drug interactions.||
3169|101|I|Keep a list of all the products you use (including||
3169|102|I|prescription/nonprescription drugs and herbal products) and share||
3169|103|I|it with your health care professional. Do not start, stop, or||
3169|104|I|change the dosage of any medicines without your doctor's||
3169|105|I|approval.||
3169|106|I|   Some products that may interact with this vaccine are: drugs||
3169|107|I|that weaken the immune system (including cyclosporine,||
3169|108|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
3169|109|I|prednisone), immune globulin, certain antiviral drugs (such as||
3169|110|I|acyclovir, famciclovir, and valacyclovir).||
3169|111|I|   All children and teenagers should avoid aspirin or||
3169|112|I|aspirin-like medications (such as salsalate) for 6 weeks after||
3169|113|I|vaccination.||
3169|114|I|   This vaccine may interfere with certain lab tests (such as TB||
3169|115|I|skin test), possibly causing false test results. Make sure lab||
3169|116|I|personnel and all your doctors know you recently received this||
3169|117|I|vaccine.||
3169|118|B|||
3169|119|O|OVERDOSE:  Not applicable.||
3169|120|B|||
3169|121|N|NOTES:  Keep all medical and lab appointments.||
3169|122|N|   Keep vaccine records for yourself and your children and||
3169|123|N|provide them to the health care professionals to prevent||
3169|124|N|unnecessary re-vaccinations.||
3169|125|B|||
3169|126|D|MISSED DOSE:  It is important that you get each vaccination as||
3169|127|D|scheduled. Ask when you should get each dose and mark your||
3169|128|D|calendar with a reminder. If you miss a dose, call the health||
3169|129|D|care professional to reschedule.||
3169|130|B|||
3169|131|R|STORAGE:  Different brands of this medication have different||
3169|132|R|storage needs. Check the product package for instructions on how||
3169|133|R|to store your brand, or ask your pharmacist. Protect from light.||
3169|134|R|Keep all medications away from children and pets.||
3169|135|R|   Do not flush medications down the toilet or pour them into a||
3169|136|R|drain unless instructed to do so. Properly discard this product||
3169|137|R|when it is expired or no longer needed. Consult your pharmacist||
3169|138|R|or local waste disposal company.||
3169|139|B|||
3169|140|A|Information last revised February 2025.||
3169|141|A|Copyright(c) 2025 First Databank, Inc.||
3169|142|B|||
3172|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3172|002|Z|does NOT have all possible information about this product. This||
3172|003|Z|information does not assure that this product is safe, effective,||
3172|004|Z|or appropriate for you. This information is not individual||
3172|005|Z|medical advice and does not substitute for the advice of your||
3172|006|Z|health care professional. Always ask your health care||
3172|007|Z|professional for complete information about this product and your||
3172|008|Z|specific health needs.||
3172|009|B|||
3172|010|T|DECONGESTANT/OPIOID ANTITUSSIVE/ANTIHISTAMINE - ORAL||
3172|011|B|||
3172|012|W|WARNING:  This medication has a risk for abuse and addiction,||
3172|013|W|which can lead to overdose and death. This medication may also||
3172|014|W|cause severe, possibly fatal, breathing problems. To lower your||
3172|015|W|risk, your doctor should have you take the smallest dose that||
3172|016|W|works, and take it for the shortest possible time. See also How||
3172|017|W|to Use section for more information about addiction.||
3172|018|W|   The risk for severe breathing problems is higher when you||
3172|019|W|start this medication, or if you take the wrong dose or take more||
3172|020|W|of this medication than prescribed. Taking this medication with||
3172|021|W|alcohol or other drugs that can cause drowsiness or breathing||
3172|022|W|problems may cause very serious side effects, including death.||
3172|023|W|Also, other medications can affect the removal of this product||
3172|024|W|from your body, which may affect how it works. Be sure you know||
3172|025|W|how to take this product and what other drugs you should avoid||
3172|026|W|taking with it. See also Drug Interactions section. Get medical||
3172|027|W|help right away if any of these very serious side effects occur:||
3172|028|W|slow/shallow breathing, unusual lightheadedness, severe||
3172|029|W|drowsiness/dizziness, difficulty waking up.||
3172|030|W|   Keep this medicine in a safe place to prevent theft, misuse,||
3172|031|W|or abuse. If someone accidentally swallows this drug, get medical||
3172|032|W|help right away.||
3172|033|W|   Before using this medication, women of childbearing age should||
3172|034|W|talk with their doctor(s) about the risks and benefits. Tell your||
3172|035|W|doctor if you are pregnant or think you may be pregnant. During||
3172|036|W|pregnancy, this medication is not recommended. It may slightly||
3172|037|W|increase the risk of birth defects if used during the first two||
3172|038|W|months of pregnancy. Also, using it for a long time or in high||
3172|039|W|doses near the expected delivery date may harm the unborn baby.||
3172|040|W|To lessen the risk, take the smallest effective dose for the||
3172|041|W|shortest possible time. Babies born to mothers who use this drug||
3172|042|W|for a long time may develop severe (possibly fatal) withdrawal||
3172|043|W|symptoms. Tell the doctor right away if you notice any symptoms||
3172|044|W|in your newborn baby such as crying that doesn't stop,||
3172|045|W|slow/shallow breathing, irritability, shaking, vomiting,||
3172|046|W|diarrhea, poor feeding, or difficulty gaining weight.||
3172|047|B|||
3172|048|U|USES:  This combination product is used to treat symptoms caused||
3172|049|U|by the common cold, flu, allergies, hay fever, or other breathing||
3172|050|U|illnesses (such as sinusitis, bronchitis). Decongestants help||
3172|051|U|relieve stuffy nose symptoms. This product also contains an||
3172|052|U|opioid cough suppressant (antitussive) that affects a certain||
3172|053|U|part of the brain, reducing the urge to cough. Antihistamines||
3172|054|U|relieve watery eyes, itchy eyes/nose/throat, runny nose, and||
3172|055|U|sneezing.||
3172|056|U|   Opioid cough suppressants should not be used by children||
3172|057|U|younger than 18 years. Children are at higher risk for serious||
3172|058|U|(even fatal) side effects, especially breathing problems. Talk||
3172|059|U|with the doctor about the risks and benefits of this medication.||
3172|060|U|   Cough-and-cold products do not cure colds. Cough due to a||
3172|061|U|common cold often does not need to be treated with medicine. Ask||
3172|062|U|your doctor or pharmacist about other ways to relieve cough and||
3172|063|U|cold symptoms, such as drinking enough fluids, using a||
3172|064|U|humidifier, or saline nose drops/spray.||
3172|065|B|||
3172|066|H|HOW TO USE:  Read the Medication Guide if available from your||
3172|067|H|pharmacist before you start taking this product and each time you||
3172|068|H|get a refill. If you have any questions, ask your doctor or||
3172|069|H|pharmacist.||
3172|070|H|   If you are taking the over-the-counter product to self-treat,||
3172|071|H|read all directions on the product package before taking this||
3172|072|H|medication. If you have any questions, consult your pharmacist.||
3172|073|H|If your doctor has prescribed this medication, take it as||
3172|074|H|directed.||
3172|075|H|   Take this medication by mouth with or without food with a full||
3172|076|H|glass of water (8 ounces or 240 milliliters) or as directed by||
3172|077|H|your doctor. This medication may be taken with food or milk if||
3172|078|H|stomach upset occurs. The dosage is based on your medical||
3172|079|H|condition and response to treatment.||
3172|080|H|   If you are using a liquid form, use a medication-measuring||
3172|081|H|device or spoon to carefully measure the prescribed dose. Do not||
3172|082|H|use a household spoon because you may not get the correct dose.||
3172|083|H|If your liquid form is a suspension, shake the bottle well before||
3172|084|H|each dose.||
3172|085|H|   If you are using sustained-release tablets or capsules,||
3172|086|H|swallow the medication whole. Do not crush, chew, or break the||
3172|087|H|tablets or capsules. Doing so can destroy the long action of the||
3172|088|H|drug and may increase side effects.||
3172|089|H|   Do not increase your dose or use this product more often or||
3172|090|H|for longer than directed. Your condition will not improve any||
3172|091|H|faster, and your risk of side effects will increase.||
3172|092|H|   If you suddenly stop using this medication, you may have||
3172|093|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
3172|094|H|nose, nausea, sweating, muscle aches). To help prevent||
3172|095|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
3172|096|H|more likely if you have used this medication for a long time||
3172|097|H|(more than a few weeks) or in high doses. Tell your doctor or||
3172|098|H|pharmacist right away if you have withdrawal.||
3172|099|H|   Though it helps many people, this product may sometimes cause||
3172|100|H|addiction. This risk may be higher if you have a mental/mood||
3172|101|H|disorder or a substance use disorder (such as overuse of or||
3172|102|H|addiction to drugs/alcohol). Take this medication exactly as||
3172|103|H|prescribed to lower the risk of addiction. Ask your doctor or||
3172|104|H|pharmacist for more details.||
3172|105|H|   When used for an extended time, this medication may not work||
3172|106|H|as well and may require different dosing. Talk with your doctor||
3172|107|H|if this medication stops working well.||
3172|108|H|   Tell your doctor if your cough does not get better in 5 days.||
3172|109|H|Also, tell your doctor if your condition gets worse, or if you||
3172|110|H|have a headache that doesn't go away, fever, or rash. These may||
3172|111|H|be symptoms of a serious medical problem and should be checked by||
3172|112|H|a doctor.||
3172|113|B|||
3172|114|S|SIDE EFFECTS:  See also Warning section.||
3172|115|S|   Drowsiness, dizziness, headache, blurred vision, upset||
3172|116|S|stomach, nausea, constipation, or dry mouth/nose/throat may||
3172|117|S|occur. If any of these effects last or get worse, notify your||
3172|118|S|doctor or pharmacist promptly.||
3172|119|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
3172|120|S|chips, chew (sugarless) gum, drink water, or use a saliva||
3172|121|S|substitute. This medication can dry up and thicken mucus in your||
3172|122|S|lungs, making it more difficult to breathe and clear your lungs.||
3172|123|S|To help prevent this effect, drink plenty of fluids unless||
3172|124|S|otherwise directed by your doctor.||
3172|125|S|   To reduce the risk of dizziness and lightheadedness, get up||
3172|126|S|slowly when rising from a sitting or lying position.||
3172|127|S|   If your doctor has directed you to use this medication,||
3172|128|S|remember that your doctor has judged that the benefit to you is||
3172|129|S|greater than the risk of side effects. Many people using this||
3172|130|S|medication do not have serious side effects.||
3172|131|S|   This medication may raise your blood pressure. Check your||
3172|132|S|blood pressure regularly and tell your doctor if the results are||
3172|133|S|high.||
3172|134|S|   Tell your doctor right away if you have any serious side||
3172|135|S|effects, including: interrupted breathing during sleep (sleep||
3172|136|S|apnea), mental/mood changes (such as hallucinations), ringing in||
3172|137|S|the ears, shaking (tremors), trouble urinating, weakness, easy||
3172|138|S|bruising/bleeding, fast/slow/irregular heartbeat, trouble||
3172|139|S|swallowing.||
3172|140|S|   Get medical help right away if you have any very serious side||
3172|141|S|effects, including: seizure.||
3172|142|S|   This product may cause serious mental/mood changes and very||
3172|143|S|serious (rarely fatal) breathing problems. This product may||
3172|144|S|contain codeine or dihydrocodeine. Codeine and dihydrocodeine are||
3172|145|S|changed into strong opioid drugs (morphine or dihydromorphine) in||
3172|146|S|your body. In some people this happens faster and more completely||
3172|147|S|than usual, which increases the risk of very serious side||
3172|148|S|effects. Get medical help right away if you notice any of the||
3172|149|S|following: slow/shallow breathing, severe drowsiness/difficulty||
3172|150|S|waking up, confusion.||
3172|151|S|   A very serious allergic reaction to this drug is rare.||
3172|152|S|However, get medical help right away if you notice any symptoms||
3172|153|S|of a serious allergic reaction, including: rash, itching/swelling||
3172|154|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3172|155|S|breathing.||
3172|156|S|   This is not a complete list of possible side effects. If you||
3172|157|S|notice other effects not listed above, contact your doctor or||
3172|158|S|pharmacist.||
3172|159|S|   In the US -||
3172|160|S|   Call your doctor for medical advice about side effects. You||
3172|161|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3172|162|S|www.fda.gov/medwatch.||
3172|163|S|   In Canada - Call your doctor for medical advice about side||
3172|164|S|effects. You may report side effects to Health Canada at||
3172|165|S|1-866-234-2345.||
3172|166|B|||
3172|167|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
3172|168|P|pharmacist if you are allergic to it; or if you have any other||
3172|169|P|allergies. This product may contain inactive ingredients, which||
3172|170|P|can cause allergic reactions or other problems. Talk to your||
3172|171|P|pharmacist for more details.||
3172|172|P|   Before using this medication, tell your doctor or pharmacist||
3172|173|P|your medical history, especially of: abdominal problems (such as||
3172|174|P|chronic constipation, ileus, gallbladder disease, pancreatitis),||
3172|175|P|adrenal gland problem (such as Addison's disease), certain brain||
3172|176|P|disorders (such as head injury, tumor, increased intracranial||
3172|177|P|pressure), breathing problems (such as asthma, emphysema, sleep||
3172|178|P|apnea), diabetes, a certain eye problem (glaucoma), heart||
3172|179|P|problems, high blood pressure, kidney problems, liver disease,||
3172|180|P|mental/mood problems (such as depression, psychosis), seizures,||
3172|181|P|stomach/intestinal problems (such as ulcers, blockage), thyroid||
3172|182|P|problems (such as hyperthyroidism, hypothyroidism), urination||
3172|183|P|problems (such as trouble urinating due to enlarged prostate,||
3172|184|P|urinary retention), personal or family history of a substance use||
3172|185|P|disorder (such as overuse of or addiction to drugs/alcohol),||
3172|186|P|obesity.||
3172|187|P|   This drug may make you dizzy or drowsy or blur your vision.||
3172|188|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3172|189|P|drowsy. Do not drive, use machinery, or do anything that needs||
3172|190|P|alertness or clear vision until you can do it safely. Avoid||
3172|191|P|alcoholic beverages. Talk to your doctor if you are using||
3172|192|P|marijuana (cannabis).||
3172|193|P|   This medicine may contain aspartame. If you have||
3172|194|P|phenylketonuria (PKU) or any other condition that requires you to||
3172|195|P|restrict your intake of aspartame (or phenylalanine), consult||
3172|196|P|your doctor or pharmacist regarding the safe use of this||
3172|197|P|medicine.||
3172|198|P|   This medication may contain sugar and/or alcohol. Caution is||
3172|199|P|advised if you have diabetes, alcohol dependence, or liver||
3172|200|P|disease. Ask your doctor or pharmacist about the safe use of this||
3172|201|P|product.||
3172|202|P|   Before having surgery, tell your doctor or dentist about all||
3172|203|P|the products you use (including prescription drugs,||
3172|204|P|nonprescription drugs, and herbal products).||
3172|205|P|   Older adults may be more sensitive to the side effects of this||
3172|206|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
3172|207|P|breathing, fast heartbeat, constipation, and trouble urinating.||
3172|208|P|Confusion, dizziness, and drowsiness can increase the risk of||
3172|209|P|falling.||
3172|210|P|   Tell your doctor if you are pregnant or think you may be||
3172|211|P|pregnant. During pregnancy, this product is not recommended. It||
3172|212|P|may harm an unborn baby. Talk to your doctor about the risks and||
3172|213|P|benefits of this medication. See also Warning section.||
3172|214|P|   This product may pass into breast milk and may have||
3172|215|P|undesirable effects on a nursing infant (such as unusual||
3172|216|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
3172|217|P|limpness). Consult your doctor before breastfeeding.||
3172|218|B|||
3172|219|I|DRUG INTERACTIONS:  See also Warning section.||
3172|220|I|   Drug interactions may change how your medications work or||
3172|221|I|increase your risk for serious side effects. This document does||
3172|222|I|not contain all possible drug interactions. Keep a list of all||
3172|223|I|the products you use (including prescription/nonprescription||
3172|224|I|drugs and herbal products) and share it with your doctor and||
3172|225|I|pharmacist. Do not start, stop, or change the dosage of any||
3172|226|I|medicines without your doctor's approval.||
3172|227|I|   Some products that may interact with this drug include:||
3172|228|I|antihistamines applied to the skin (such as diphenhydramine||
3172|229|I|cream, ointment, spray), naltrexone, samidorphan.||
3172|230|I|   Taking MAO inhibitors with this medication may cause a serious||
3172|231|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
3172|232|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
3172|233|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
3172|234|I|selegiline, tranylcypromine) during treatment with this||
3172|235|I|medication. Most MAO inhibitors should also not be taken for two||
3172|236|I|weeks before treatment with this medication. Ask your doctor when||
3172|237|I|to start or stop taking this medication.||
3172|238|I|   The risk of serious side effects (such as slow/shallow||
3172|239|I|breathing, severe drowsiness/dizziness) may be increased if this||
3172|240|I|medication is taken with other products that may also cause||
3172|241|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
3172|242|I|if you are taking other products such as other opioid pain or||
3172|243|I|cough relievers (such as codeine, hydrocodone), alcohol,||
3172|244|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
3172|245|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
3172|246|I|carisoprodol, cyclobenzaprine), or other antihistamines (such as||
3172|247|I|cetirizine, diphenhydramine).||
3172|248|I|   Check the labels on all your medicines (such as allergy or||
3172|249|I|cough-and-cold products) because they may contain ingredients||
3172|250|I|that cause drowsiness. Ask your pharmacist about using those||
3172|251|I|products safely.||
3172|252|I|   Other medications can affect the removal of this product from||
3172|253|I|your body, which may affect how this product works. Examples||
3172|254|I|include azole antifungals (such as ketoconazole), bupropion,||
3172|255|I|fluoxetine, macrolide antibiotics (such as erythromycin),||
3172|256|I|paroxetine, quinidine, rifamycins (such as rifabutin, rifampin),||
3172|257|I|ritonavir, certain drugs used to treat seizures (such as||
3172|258|I|carbamazepine, phenytoin), among others.||
3172|259|I|   This medication may interfere with certain medical/lab tests||
3172|260|I|(such as amylase/lipase levels, allergy skin test, brain scan for||
3172|261|I|Parkinson's disease), possibly causing false test results. Make||
3172|262|I|sure lab personnel and all your doctors know you use this drug.||
3172|263|B|||
3172|264|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3172|265|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3172|266|O|poison control center right away. US residents can call||
3172|267|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3172|268|O|Symptoms of overdose may include: confusion, cold/clammy skin,||
3172|269|O|fast/slow/irregular heartbeat, slow/shallow breathing, seizures,||
3172|270|O|coma.||
3172|271|B|||
3172|272|N|NOTES:  If your doctor has prescribed this medication, do not||
3172|273|N|share it with others. Sharing it is against the law.||
3172|274|B|||
3172|275|D|MISSED DOSE:  If you are taking this product on a regular||
3172|276|D|schedule and miss a dose, take it as soon as you remember. If it||
3172|277|D|is near the time of the next dose, skip the missed dose. Take||
3172|278|D|your next dose at the regular time. Do not double the dose to||
3172|279|D|catch up.||
3172|280|B|||
3172|281|R|STORAGE:  Store at room temperature away from light and moisture.||
3172|282|R|Do not store in the bathroom. Do not freeze liquid forms of this||
3172|283|R|medication. Keep all medications away from children and pets.||
3172|284|R|   Do not flush medications down the toilet or pour them into a||
3172|285|R|drain unless instructed to do so. Properly discard this product||
3172|286|R|when it is expired or no longer needed. Consult your pharmacist||
3172|287|R|or local waste disposal company.||
3172|288|B|||
3172|289|A|Information last revised August 2025.||
3172|290|A|Copyright(c) 2025 First Databank, Inc.||
3172|291|B|||
3174|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3174|002|Z|does NOT have all possible information about this product. This||
3174|003|Z|information does not assure that this product is safe, effective,||
3174|004|Z|or appropriate for you. This information is not individual||
3174|005|Z|medical advice and does not substitute for the advice of your||
3174|006|Z|health care professional. Always ask your health care||
3174|007|Z|professional for complete information about this product and your||
3174|008|Z|specific health needs.||
3174|009|B|||
3174|010|T|RALOXIFENE - ORAL||
3174|011|F|(ral-OX-i-feen)||
3174|012|B|||
3174|013|C|COMMON BRAND NAME(S): Evista||
3174|014|B|||
3174|015|W|WARNING:  Raloxifene may rarely cause serious blood clots,||
3174|016|W|especially in the legs or lungs. Women who have or had blood||
3174|017|W|clots (including in the legs, lungs, or eyes) should not take||
3174|018|W|raloxifene. Also, women who have had a heart attack or are at||
3174|019|W|risk for a heart attack may rarely have an increased risk of||
3174|020|W|dying from a stroke while taking raloxifene. Before starting||
3174|021|W|treatment with raloxifene, tell your doctor if you have or had||
3174|022|W|blood clots in your legs/lungs/eyes, a stroke, mini-stroke (TIA),||
3174|023|W|heart disease, heart attack, high cholesterol, irregular||
3174|024|W|heartbeat called atrial fibrillation, high blood pressure, or if||
3174|025|W|you smoke. Discuss these risks and the benefits of using||
3174|026|W|raloxifene with your doctor.||
3174|027|B|||
3174|028|U|USES:  Raloxifene is used by women to prevent and treat bone loss||
3174|029|U|(osteoporosis) after menopause. It slows down bone loss and helps||
3174|030|U|to keep bones strong, making them less likely to break.||
3174|031|U|   Raloxifene may also lower the chance of getting a certain type||
3174|032|U|of breast cancer (invasive breast cancer) after menopause.||
3174|033|U|   Raloxifene is not an estrogen hormone, but it acts like||
3174|034|U|estrogen in some parts of the body, like your bones. In other||
3174|035|U|parts of the body (uterus and breasts), raloxifene acts like an||
3174|036|U|estrogen blocker. It does not relieve menopause symptoms such as||
3174|037|U|hot flashes. Raloxifene belongs to a class of drugs known as||
3174|038|U|selective estrogen receptor modulators-SERMs.||
3174|039|U|   This medication should not be used before menopause.||
3174|040|U|   It should not be used to prevent heart disease.||
3174|041|B|||
3174|042|H|HOW TO USE:  Read the Medication Guide provided by your||
3174|043|H|pharmacist before you start taking raloxifene and each time you||
3174|044|H|get a refill. If you have any questions, ask your doctor or||
3174|045|H|pharmacist.||
3174|046|H|   Take this medication by mouth with or without food as directed||
3174|047|H|by your doctor, usually once daily. Take this medication||
3174|048|H|regularly to get the most benefit from it. To help you remember,||
3174|049|H|take it at the same time each day.||
3174|050|H|   Swallow the tablet whole. Do not crush or chew because the||
3174|051|H|drug has a bitter taste.||
3174|052|H|   Be sure to get enough calcium and vitamin D in your diet.||
3174|053|H|Consult your doctor or pharmacist to see if you need to take||
3174|054|H|calcium and vitamin D supplements.||
3174|055|H|   Since this drug can be absorbed through the skin and lungs and||
3174|056|H|may harm an unborn baby, women who are pregnant or who may become||
3174|057|H|pregnant should not handle this medication or breathe the dust||
3174|058|H|from the tablets.||
3174|059|B|||
3174|060|S|SIDE EFFECTS:  Hot flashes or leg cramps may occur. If either of||
3174|061|S|these effects lasts or gets worse, tell your doctor or pharmacist||
3174|062|S|promptly.||
3174|063|S|   Remember that this medication has been prescribed because your||
3174|064|S|doctor has judged that the benefit to you is greater than the||
3174|065|S|risk of side effects. Many people using this medication do not||
3174|066|S|have serious side effects.||
3174|067|S|   Get medical help right away if you have any very serious side||
3174|068|S|effects, including: signs of a blood clot (such as sudden||
3174|069|S|pain/swelling/redness/warmth in the leg or arm, chest pain,||
3174|070|S|trouble breathing, coughing up blood, sudden vision changes like||
3174|071|S|blurred vision/loss of vision), signs of a stroke (such as||
3174|072|S|weakness on one side of the body, trouble speaking, sudden vision||
3174|073|S|changes, confusion).||
3174|074|S|   A very serious allergic reaction to this drug is rare.||
3174|075|S|However, get medical help right away if you notice any symptoms||
3174|076|S|of a serious allergic reaction, including: rash, itching/swelling||
3174|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3174|078|S|breathing.||
3174|079|S|   This is not a complete list of possible side effects. If you||
3174|080|S|notice other effects not listed above, contact your doctor or||
3174|081|S|pharmacist.||
3174|082|S|   In the US -||
3174|083|S|   Call your doctor for medical advice about side effects. You||
3174|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3174|085|S|www.fda.gov/medwatch.||
3174|086|S|   In Canada - Call your doctor for medical advice about side||
3174|087|S|effects. You may report side effects to Health Canada at||
3174|088|S|1-866-234-2345.||
3174|089|B|||
3174|090|P|PRECAUTIONS:  See also Warning section.||
3174|091|P|   Before taking raloxifene, tell your doctor or pharmacist if||
3174|092|P|you are allergic to it, or if you have any other allergies. This||
3174|093|P|product may contain inactive ingredients, which can cause||
3174|094|P|allergic reactions or other problems. Talk to your pharmacist for||
3174|095|P|more details.||
3174|096|P|   Before using this medication, tell your doctor or pharmacist||
3174|097|P|your medical history, especially of: blood clots (including in||
3174|098|P|the legs/lungs/eyes), stroke, mini-stroke (TIA), heart disease||
3174|099|P|(blocked blood vessels in the heart), heart attack, high||
3174|100|P|cholesterol, irregular heartbeat called atrial fibrillation, high||
3174|101|P|blood pressure, smoking, kidney disease, liver disease, heart||
3174|102|P|failure, cancer, high blood fat (triglyceride) levels caused by||
3174|103|P|estrogen treatment.||
3174|104|P|   Tell your doctor if you just had or will be having surgery or||
3174|105|P|if you will be confined to a bed or chair for a long time (such||
3174|106|P|as a long plane flight). These conditions increase your risk of||
3174|107|P|getting blood clots, especially if you are using raloxifene. You||
3174|108|P|may need to stop this medication for a time or take special||
3174|109|P|precautions.||
3174|110|P|   This medication must not be used during pregnancy. It may harm||
3174|111|P|an unborn baby. If you become pregnant or think you may be||
3174|112|P|pregnant, tell your doctor right away.||
3174|113|P|   It is unknown if this drug passes into breast milk. Consult||
3174|114|P|your doctor before breastfeeding.||
3174|115|B|||
3174|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3174|117|I|medications work or increase your risk for serious side effects.||
3174|118|I|This document does not contain all possible drug interactions.||
3174|119|I|Keep a list of all the products you use (including||
3174|120|I|prescription/nonprescription drugs and herbal products) and share||
3174|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
3174|122|I|the dosage of any medicines without your doctor's approval.||
3174|123|I|   Some products that may interact with this drug include: bile||
3174|124|I|acid-binding resins (such as cholestyramine, colestipol),||
3174|125|I|estrogens, tibolone.||
3174|126|I|   This medication may interfere with certain lab tests, possibly||
3174|127|I|causing false test results. Make sure lab personnel and all your||
3174|128|I|doctors know you use this drug.||
3174|129|B|||
3174|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3174|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3174|132|O|poison control center right away. US residents can call||
3174|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3174|134|O|Symptoms of overdose may include: dizziness, vomiting.||
3174|135|B|||
3174|136|N|NOTES:  Do not share this medication with others.||
3174|137|N|   Lab and/or medical tests (such as bone density tests, X-rays,||
3174|138|N|height measurement, blood mineral levels) should be done while||
3174|139|N|you are taking this medication. Keep all medical and lab||
3174|140|N|appointments.||
3174|141|N|   You should have regular complete physical exams (for example,||
3174|142|N|once a year) which include breast and pelvic exams, and Pap||
3174|143|N|smear. You should also have periodic mammograms as determined by||
3174|144|N|your doctor. Follow your doctor's instructions for examining your||
3174|145|N|own breasts. Report any unusual vaginal bleeding, breast pain, or||
3174|146|N|lumps right away.||
3174|147|N|   Lifestyle changes that help promote healthy bones include||
3174|148|N|increasing weight-bearing exercise, stopping smoking, limiting||
3174|149|N|alcohol, and eating well-balanced meals that contain adequate||
3174|150|N|calcium and vitamin D. You may also need to take calcium and||
3174|151|N|vitamin D supplements. Consult your doctor for specific advice.||
3174|152|B|||
3174|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3174|154|D|remember. If it is near the time of the next dose, skip the||
3174|155|D|missed dose. Take your next dose at the regular time. Do not||
3174|156|D|double the dose to catch up.||
3174|157|B|||
3174|158|R|STORAGE:  Store at room temperature away from light and moisture.||
3174|159|R|Do not store in the bathroom. Keep all medications away from||
3174|160|R|children and pets.||
3174|161|R|   Do not flush medications down the toilet or pour them into a||
3174|162|R|drain unless instructed to do so. Properly discard this product||
3174|163|R|when it is expired or no longer needed. Consult your pharmacist||
3174|164|R|or local waste disposal company.||
3174|165|B|||
3174|166|A|Information last revised May 2024.||
3174|167|A|Copyright(c) 2025 First Databank, Inc.||
3174|168|B|||
3179|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3179|002|Z|does NOT have all possible information about this product. This||
3179|003|Z|information does not assure that this product is safe, effective,||
3179|004|Z|or appropriate for you. This information is not individual||
3179|005|Z|medical advice and does not substitute for the advice of your||
3179|006|Z|health care professional. Always ask your health care||
3179|007|Z|professional for complete information about this product and your||
3179|008|Z|specific health needs.||
3179|009|B|||
3179|010|T|FLUCYTOSINE - ORAL||
3179|011|F|(flew-SYE-toe-seen)||
3179|012|B|||
3179|013|C|COMMON BRAND NAME(S): Ancobon||
3179|014|B|||
3179|015|W|WARNING:  This medication should be used with increased caution||
3179|016|W|if you have kidney problems. Flucytosine may cause decreased||
3179|017|W|kidney function and liver problems. In addition, this medication||
3179|018|W|may decrease bone marrow function. This serious, possibly||
3179|019|W|life-threatening side effect may lead to a low number of blood||
3179|020|W|cells such as red cells, white cells, and platelets. This effect||
3179|021|W|can cause anemia, decrease your body's ability to fight an||
3179|022|W|infection, and cause bleeding problems. Your doctor will check||
3179|023|W|the results of your kidney, liver, and blood tests and adjust||
3179|024|W|your treatment to reduce your risk for these side effects. See||
3179|025|W|also Side Effects section.||
3179|026|B|||
3179|027|U|USES:  Flucytosine is used to treat serious fungal infections in||
3179|028|U|the body. It belongs to a class of drugs known as antifungal||
3179|029|U|drugs. It is often used with other medications. It works by||
3179|030|U|slowing the growth of certain types of fungus.||
3179|031|B|||
3179|032|H|HOW TO USE:  Take this medication by mouth as directed by your||
3179|033|H|doctor, usually 4 times a day (every 6 hours). To reduce stomach||
3179|034|H|upset, do not swallow all of the capsules for one dose at the||
3179|035|H|same time. It may be best to swallow the capsules for each dose||
3179|036|H|over a 15-minute period until the full dose is taken.||
3179|037|H|   The dosage is based on your medical condition, weight, and||
3179|038|H|response to treatment.||
3179|039|H|   This medication works best when the amount of drug in your||
3179|040|H|body is kept at a constant level. Take this drug at evenly spaced||
3179|041|H|intervals. To help you remember, take it at the same times each||
3179|042|H|day.||
3179|043|H|   Continue to take this medication until the full prescribed||
3179|044|H|amount is finished, even if symptoms disappear after a few days.||
3179|045|H|Stopping the medication too early may result in a return of the||
3179|046|H|infection.||
3179|047|H|   Tell your doctor right away if your condition lasts or gets||
3179|048|H|worse.||
3179|049|B|||
3179|050|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. See the||
3179|051|S|How to Use section about how to reduce stomach upset. If any of||
3179|052|S|these effects last or get worse, tell your doctor or pharmacist||
3179|053|S|promptly.||
3179|054|S|   Remember that this medication has been prescribed because your||
3179|055|S|doctor has judged that the benefit to you is greater than the||
3179|056|S|risk of side effects. Many people using this medication do not||
3179|057|S|have serious side effects.||
3179|058|S|   Tell your doctor right away if you have any serious side||
3179|059|S|effects, including: signs of kidney problems (such as change in||
3179|060|S|the amount of urine), signs of liver problems (such as||
3179|061|S|nausea/vomiting that doesn't stop, stomach/abdominal pain, dark||
3179|062|S|urine, yellowing eyes/skin), signs of anemia (such as unusual||
3179|063|S|tiredness, fast breathing, pale skin, fast heartbeat), signs of||
3179|064|S|infection (such as sore throat that doesn't go away, fever,||
3179|065|S|chills), signs of bleeding (such as easy bruising/bleeding, nose||
3179|066|S|bleeds, bleeding gums, bloody/black/tarry stools, vomit that||
3179|067|S|looks like coffee grounds), muscle weakness/cramping.||
3179|068|S|   A very serious allergic reaction to this drug is rare.||
3179|069|S|However, get medical help right away if you notice any symptoms||
3179|070|S|of a serious allergic reaction, including: rash, itching/swelling||
3179|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3179|072|S|breathing.||
3179|073|S|   This is not a complete list of possible side effects. If you||
3179|074|S|notice other effects not listed above, contact your doctor or||
3179|075|S|pharmacist.||
3179|076|S|   In the US -||
3179|077|S|   Call your doctor for medical advice about side effects. You||
3179|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3179|079|S|www.fda.gov/medwatch.||
3179|080|S|   In Canada - Call your doctor for medical advice about side||
3179|081|S|effects. You may report side effects to Health Canada at||
3179|082|S|1-866-234-2345.||
3179|083|B|||
3179|084|P|PRECAUTIONS:  Before taking flucytosine, tell your doctor or||
3179|085|P|pharmacist if you are allergic to it; or if you have any other||
3179|086|P|allergies. This product may contain inactive ingredients, which||
3179|087|P|can cause allergic reactions or other problems. Talk to your||
3179|088|P|pharmacist for more details.||
3179|089|P|   Before using this medication, tell your doctor or pharmacist||
3179|090|P|your medical history, especially of: kidney problems, liver||
3179|091|P|problems, decreased bone marrow function (low white, red or||
3179|092|P|platelet blood counts), a certain metabolic disorder (DPD enzyme||
3179|093|P|deficiency), radiation treatment, mineral imbalance (such as low||
3179|094|P|level of potassium in the blood).||
3179|095|P|   Flucytosine can make you more likely to get infections or may||
3179|096|P|make current infections worse. Stay away from anyone who has an||
3179|097|P|infection that may easily spread (such as chickenpox, COVID-19,||
3179|098|P|measles, flu). Talk to your doctor if you have been exposed to an||
3179|099|P|infection or for more details.||
3179|100|P|   Tell your health care professional that you are using||
3179|101|P|flucytosine before having any immunizations/vaccinations. Avoid||
3179|102|P|contact with people who have recently received live vaccines||
3179|103|P|(such as flu vaccine inhaled through the nose).||
3179|104|P|   To lower the chance of getting cut, bruised, or injured, use||
3179|105|P|caution with sharp objects like razors and nail cutters, and||
3179|106|P|avoid activities such as contact sports.||
3179|107|P|   During pregnancy, this medication should be used only when||
3179|108|P|clearly needed. This medication is not recommended for use during||
3179|109|P|the first 3 months of pregnancy. It may harm an unborn baby.||
3179|110|P|Discuss the risks and benefits with your doctor.||
3179|111|P|   It is unknown if this drug passes into breast milk. Because of||
3179|112|P|the possible risk to the infant, breastfeeding is not recommended||
3179|113|P|while using this drug. Consult your doctor before breastfeeding.||
3179|114|B|||
3179|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3179|116|I|medications work or increase your risk for serious side effects.||
3179|117|I|This document does not contain all possible drug interactions.||
3179|118|I|Keep a list of all the products you use (including||
3179|119|I|prescription/nonprescription drugs and herbal products) and share||
3179|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
3179|121|I|the dosage of any medicines without your doctor's approval.||
3179|122|I|   Some products that may interact with this drug are:||
3179|123|I|cytarabine, other drugs that may affect the kidneys (including||
3179|124|I|NSAIDs such as ibuprofen or naproxen), other drugs that decrease||
3179|125|I|bone marrow function or lower your number of blood cells or||
3179|126|I|weaken the immune system (such as cancer chemotherapy,||
3179|127|I|trimethoprim/sulfamethoxazole).||
3179|128|I|   This medication may interfere with certain lab tests (such as||
3179|129|I|serum creatinine), possibly causing false test results. Make sure||
3179|130|I|lab personnel and all your doctors know you use this drug.||
3179|131|B|||
3179|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3179|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3179|134|O|poison control center right away. US residents can call||
3179|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3179|136|B|||
3179|137|N|NOTES:  Do not share this medication with others.||
3179|138|N|   Lab and/or medical tests (such as kidney/liver function, blood||
3179|139|N|cell counts, blood mineral levels) should be done while you are||
3179|140|N|taking this medication. Keep all medical and lab appointments.||
3179|141|N|Consult your doctor for more details.||
3179|142|B|||
3179|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3179|144|D|remember. If it is near the time of the next dose, skip the||
3179|145|D|missed dose. Take your next dose at the regular time. Do not||
3179|146|D|double the dose to catch up.||
3179|147|B|||
3179|148|R|STORAGE:  Store at room temperature away from light and moisture.||
3179|149|R|Do not store in the bathroom. Keep all medications away from||
3179|150|R|children and pets.||
3179|151|R|   Do not flush medications down the toilet or pour them into a||
3179|152|R|drain unless instructed to do so. Properly discard this product||
3179|153|R|when it is expired or no longer needed. Consult your pharmacist||
3179|154|R|or local waste disposal company.||
3179|155|B|||
3179|156|A|Information last revised April 2025.||
3179|157|A|Copyright(c) 2025 First Databank, Inc.||
3179|158|B|||
3186|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3186|002|Z|does NOT have all possible information about this product. This||
3186|003|Z|information does not assure that this product is safe, effective,||
3186|004|Z|or appropriate for you. This information is not individual||
3186|005|Z|medical advice and does not substitute for the advice of your||
3186|006|Z|health care professional. Always ask your health care||
3186|007|Z|professional for complete information about this product and your||
3186|008|Z|specific health needs.||
3186|009|B|||
3186|010|T|IBUPROFEN SUSPENSION - ORAL||
3186|011|F|(EYE-bue-PROE-fen)||
3186|012|B|||
3186|013|C|COMMON BRAND NAME(S): Children's Advil, Children's Motrin||
3186|014|B|||
3186|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
3186|016|W|ibuprofen) may rarely increase the risk for a heart attack or||
3186|017|W|stroke. This effect can happen at any time while taking this drug||
3186|018|W|but is more likely if you take it for a long time. The risk may||
3186|019|W|be greater in older adults or if you have heart disease or||
3186|020|W|increased risk for heart disease (for example, due to smoking,||
3186|021|W|family history of heart disease, or conditions such as high blood||
3186|022|W|pressure or diabetes). Do not take this drug right before or||
3186|023|W|after heart bypass surgery (CABG).||
3186|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
3186|025|W|from the stomach or intestines. This effect can occur without||
3186|026|W|warning at any time while taking this drug. Older adults may be||
3186|027|W|at higher risk for this effect.||
3186|028|W|   Stop taking ibuprofen and get medical help right away if you||
3186|029|W|notice any of these rare but serious side effects:||
3186|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
3186|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
3186|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
3186|033|W|side of the body, trouble speaking, sudden vision changes.||
3186|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
3186|035|W|of taking this drug.||
3186|036|B|||
3186|037|U|USES:  Ibuprofen is used to relieve pain from various conditions||
3186|038|U|such as headache, dental pain, menstrual cramps, muscle aches, or||
3186|039|U|arthritis. It is also used to reduce fever and to relieve minor||
3186|040|U|aches and pain due to the common cold or flu. Ibuprofen is a||
3186|041|U|nonsteroidal anti-inflammatory drug (NSAID). It works by blocking||
3186|042|U|your body's production of certain natural substances that cause||
3186|043|U|inflammation. This effect helps to decrease swelling, pain, or||
3186|044|U|fever.||
3186|045|U|   If you are treating a chronic condition such as arthritis, ask||
3186|046|U|your doctor about non-drug treatments and/or using other||
3186|047|U|medications to treat your pain. See also Warning section.||
3186|048|U|   This form of ibuprofen is intended for use in children. Do not||
3186|049|U|give this medication to a child younger than 2 years unless||
3186|050|U|directed by the doctor.||
3186|051|U|   Check the ingredients on the label even if you have used the||
3186|052|U|product before. The manufacturer may have changed the||
3186|053|U|ingredients. Also, products with similar names may contain||
3186|054|U|different ingredients meant for different purposes. Taking the||
3186|055|U|wrong product could harm you.||
3186|056|B|||
3186|057|H|HOW TO USE:  If you are taking the over-the-counter product, read||
3186|058|H|all directions on the product package before taking this||
3186|059|H|medication. If your doctor has prescribed this medication, read||
3186|060|H|the Medication Guide provided by your pharmacist before you start||
3186|061|H|using ibuprofen and each time you get a refill. If you have any||
3186|062|H|questions, ask your doctor or pharmacist.||
3186|063|H|   Take this medication by mouth as directed by your doctor or||
3186|064|H|the package label, usually every 6 to 8 hours as needed. Shake||
3186|065|H|the bottle well before each dose. Carefully measure the dose||
3186|066|H|using a special measuring device/spoon. Do not use a household||
3186|067|H|spoon because you may not get the correct dose. If you have||
3186|068|H|stomach upset while taking this medication, take it with food,||
3186|069|H|milk, or an antacid.||
3186|070|H|   The dosage is based on your medical condition and response to||
3186|071|H|treatment. To reduce your risk of stomach bleeding and other side||
3186|072|H|effects, take this medication at the lowest effective dose for||
3186|073|H|the shortest possible time. Do not increase your dose or take||
3186|074|H|this drug more often than directed by your doctor or the package||
3186|075|H|label.||
3186|076|H|   Children's dosage is based on weight. Read the package||
3186|077|H|directions to find the proper dose for your child's weight.||
3186|078|H|Consult the pharmacist or doctor if you have questions or if you||
3186|079|H|need help choosing a nonprescription product.||
3186|080|H|   If you are using this drug "as needed" (not on a regular||
3186|081|H|schedule), remember that pain medications work best if they are||
3186|082|H|used as the first signs of pain occur. If you wait until the pain||
3186|083|H|has worsened, the medication may not work as well.||
3186|084|H|   If your condition lasts or gets worse, or if you think you may||
3186|085|H|have a serious medical problem, get medical help right away. If||
3186|086|H|you are using the nonprescription product to treat yourself or a||
3186|087|H|child for fever or pain, consult the doctor right away if fever||
3186|088|H|gets worse or lasts more than 3 days, or if pain gets worse or||
3186|089|H|lasts more than 10 days.||
3186|090|B|||
3186|091|S|SIDE EFFECTS:  See also Warning section.||
3186|092|S|   Upset stomach, nausea, vomiting, headache, diarrhea,||
3186|093|S|constipation, dizziness, or drowsiness may occur. If any of these||
3186|094|S|effects last or get worse, tell your doctor or pharmacist||
3186|095|S|promptly.||
3186|096|S|   If your doctor has directed you to use this medication,||
3186|097|S|remember that your doctor has judged that the benefit to you is||
3186|098|S|greater than the risk of side effects. Many people using this||
3186|099|S|medication do not have serious side effects.||
3186|100|S|   This medication may raise your blood pressure. Check your||
3186|101|S|blood pressure regularly and tell your doctor if the results are||
3186|102|S|high.||
3186|103|S|   Tell your doctor right away if you have any serious side||
3186|104|S|effects, including: easy bruising/bleeding, hearing changes (such||
3186|105|S|as ringing in the ears), mental/mood changes, unexplained stiff||
3186|106|S|neck, signs of kidney problems (such as change in the amount of||
3186|107|S|urine), vision changes, symptoms of heart failure (such as||
3186|108|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
3186|109|S|gain).||
3186|110|S|   This drug may rarely cause serious (possibly fatal) liver||
3186|111|S|disease. Get medical help right away if you have any symptoms of||
3186|112|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
3186|113|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
3186|114|S|eyes/skin.||
3186|115|S|   A very serious allergic reaction to this drug is rare.||
3186|116|S|However, get medical help right away if you notice any symptoms||
3186|117|S|of a serious allergic reaction, including: fever, swollen lymph||
3186|118|S|nodes, rash, itching/swelling (especially of the||
3186|119|S|face/tongue/throat), severe dizziness, trouble breathing.||
3186|120|S|   This is not a complete list of possible side effects. If you||
3186|121|S|notice other effects not listed above, contact your doctor or||
3186|122|S|pharmacist.||
3186|123|S|   In the US -||
3186|124|S|   Call your doctor for medical advice about side effects. You||
3186|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3186|126|S|www.fda.gov/medwatch.||
3186|127|S|   In Canada - Call your doctor for medical advice about side||
3186|128|S|effects. You may report side effects to Health Canada at||
3186|129|S|1-866-234-2345.||
3186|130|B|||
3186|131|P|PRECAUTIONS:  Before using ibuprofen, tell the doctor or||
3186|132|P|pharmacist if you are allergic to it; or to aspirin or other||
3186|133|P|NSAIDs (such as naproxen, celecoxib); or if you have any other||
3186|134|P|allergies. This product may contain inactive ingredients, which||
3186|135|P|can cause allergic reactions or other problems. Talk to your||
3186|136|P|pharmacist for more details.||
3186|137|P|   Before using this medication, tell your doctor or pharmacist||
3186|138|P|your medical history, especially of: asthma (including a history||
3186|139|P|of worsening breathing after taking aspirin or other NSAIDs),||
3186|140|P|blood disorders (such as anemia, bleeding/clotting problems),||
3186|141|P|growths in the nose (nasal polyps), heart disease (such as||
3186|142|P|previous heart attack), high blood pressure, liver disease,||
3186|143|P|stroke, throat/stomach/intestinal problems (such as bleeding,||
3186|144|P|heartburn, ulcers).||
3186|145|P|   Kidney problems can sometimes occur with the use of NSAID||
3186|146|P|medications, including ibuprofen. Problems are more likely to||
3186|147|P|occur if you are dehydrated, have heart failure or kidney||
3186|148|P|disease, are an older adult, or if you take certain medications||
3186|149|P|(see also Drug Interactions section). Drink plenty of fluids as||
3186|150|P|directed by your doctor to prevent dehydration and tell your||
3186|151|P|doctor right away if you have a change in the amount of urine.||
3186|152|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3186|153|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3186|154|P|machinery, or do anything that needs alertness until you can do||
3186|155|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
3186|156|P|are using marijuana (cannabis).||
3186|157|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
3186|158|P|and tobacco, especially when combined with this medicine, may||
3186|159|P|increase your risk for stomach bleeding. Limit alcohol and stop||
3186|160|P|smoking. Consult your doctor or pharmacist for more information.||
3186|161|P|   This medication may make you more sensitive to the sun. Limit||
3186|162|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
3186|163|P|sunscreen and wear protective clothing when outdoors. Tell your||
3186|164|P|doctor right away if you get sunburned or have skin||
3186|165|P|blisters/redness.||
3186|166|P|   This product may contain sugar and/or aspartame. Caution is||
3186|167|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
3186|168|P|condition that requires you to limit/avoid these substances in||
3186|169|P|your diet. Ask your doctor or pharmacist about using this product||
3186|170|P|safely.||
3186|171|P|   Before having surgery, tell your doctor or dentist about all||
3186|172|P|the products you use (including prescription drugs,||
3186|173|P|nonprescription drugs, and herbal products).||
3186|174|P|   Older adults may be at greater risk for stomach/intestinal||
3186|175|P|bleeding, kidney problems, heart attack, and stroke while using||
3186|176|P|this drug.||
3186|177|P|   Before using this medication, women of childbearing age should||
3186|178|P|talk with their doctor(s) about the benefits and risks. Tell your||
3186|179|P|doctor if you are pregnant or if you plan to become pregnant.||
3186|180|P|This medication may harm an unborn baby and cause problems with||
3186|181|P|normal labor/delivery. It is not recommended for use in pregnancy||
3186|182|P|from 20 weeks until delivery. If your doctor decides that you||
3186|183|P|need to use this medication between 20 and 30 weeks of pregnancy,||
3186|184|P|you should use the lowest effective dose for the shortest||
3186|185|P|possible time. You should not use this medication after 30 weeks||
3186|186|P|of pregnancy.||
3186|187|P|   This medication passes into breast milk, but is unlikely to||
3186|188|P|harm a nursing infant. Consult your doctor before breastfeeding.||
3186|189|B|||
3186|190|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3186|191|I|medications work or increase your risk for serious side effects.||
3186|192|I|This document does not contain all possible drug interactions.||
3186|193|I|Keep a list of all the products you use (including||
3186|194|I|prescription/nonprescription drugs and herbal products) and share||
3186|195|I|it with your doctor and pharmacist. Do not start, stop, or change||
3186|196|I|the dosage of any medicines without your doctor's approval.||
3186|197|I|   Some products that may interact with this drug include:||
3186|198|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
3186|199|I|angiotensin II receptor blockers (such as valsartan, losartan),||
3186|200|I|cidofovir, corticosteroids (such as prednisone), lithium, "water||
3186|201|I|pills" (diuretics such as furosemide).||
3186|202|I|   This medication may increase the risk of bleeding when taken||
3186|203|I|with other drugs that also may cause bleeding. Examples include||
3186|204|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
3186|205|I|dabigatran/enoxaparin/warfarin, among others.||
3186|206|I|   Check all prescription and nonprescription medicine labels||
3186|207|I|carefully since many medications contain pain relievers/fever||
3186|208|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
3186|209|I|or naproxen). These drugs are similar to ibuprofen and may||
3186|210|I|increase your risk of side effects if taken together. However, if||
3186|211|I|your doctor has told you to take low-dose aspirin to prevent||
3186|212|I|heart attack or stroke (usually 81-162 milligrams a day), you||
3186|213|I|should keep taking the aspirin unless your doctor tells you not||
3186|214|I|to. Daily use of ibuprofen may decrease aspirin's ability to||
3186|215|I|prevent heart attack/stroke. Talk to your doctor about using a||
3186|216|I|different medication (such as acetaminophen) to treat pain/fever.||
3186|217|I|If you must take ibuprofen, talk to your doctor about taking||
3186|218|I|immediate-release aspirin (not enteric-coated/EC) while taking||
3186|219|I|ibuprofen. Take ibuprofen at least 8 hours before or at least 2||
3186|220|I|hours after your aspirin dose. Do not increase your daily dose of||
3186|221|I|aspirin or change the way you take aspirin/other medications||
3186|222|I|without your doctor's approval.||
3186|223|B|||
3186|224|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3186|225|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3186|226|O|poison control center right away. US residents can call||
3186|227|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3186|228|O|Symptoms of overdose may include: severe stomach pain, trouble||
3186|229|O|breathing, extreme drowsiness.||
3186|230|B|||
3186|231|N|NOTES:  If your doctor has prescribed this medication, do not||
3186|232|N|share it with others.||
3186|233|N|   Lab and/or medical tests (such as blood pressure, kidney||
3186|234|N|function) may be done while you are taking this medication. Keep||
3186|235|N|all medical and lab appointments. Consult your doctor for more||
3186|236|N|details.||
3186|237|B|||
3186|238|D|MISSED DOSE:  If you are using this drug on a regular schedule||
3186|239|D|(not just "as needed") and you miss a dose, take it as soon as||
3186|240|D|you remember. If it is near the time of the next dose, skip the||
3186|241|D|missed dose. Take your next dose at the regular time. Do not||
3186|242|D|double the dose to catch up.||
3186|243|B|||
3186|244|R|STORAGE:  Store at room temperature. Keep all medications away||
3186|245|R|from children and pets.||
3186|246|R|   Do not flush medications down the toilet or pour them into a||
3186|247|R|drain unless instructed to do so. Properly discard this product||
3186|248|R|when it is expired or no longer needed. Consult your pharmacist||
3186|249|R|or local waste disposal company.||
3186|250|B|||
3186|251|A|Information last revised October 2024.||
3186|252|A|Copyright(c) 2025 First Databank, Inc.||
3186|253|B|||
3187|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3187|002|Z|does NOT have all possible information about this product. This||
3187|003|Z|information does not assure that this product is safe, effective,||
3187|004|Z|or appropriate for you. This information is not individual||
3187|005|Z|medical advice and does not substitute for the advice of your||
3187|006|Z|health care professional. Always ask your health care||
3187|007|Z|professional for complete information about this product and your||
3187|008|Z|specific health needs.||
3187|009|B|||
3187|010|T|AMIFOSTINE - INJECTION||
3187|011|F|(A-mi-FOS-teen)||
3187|012|B|||
3187|013|C|COMMON BRAND NAME(S): Ethyol||
3187|014|B|||
3187|015|U|USES:  Amifostine is used to decrease the risk of kidney problems||
3187|016|U|caused by treatment with a certain anti-cancer drug (cisplatin).||
3187|017|U|It is also used to help prevent a certain side effect (dry mouth)||
3187|018|U|caused by radiation treatment for head and neck cancer.||
3187|019|U|Amifostine is thought to work by preventing certain chemicals||
3187|020|U|from damaging healthy cells. It may also help repair cells||
3187|021|U|damaged by cisplatin or radiation treatment.||
3187|022|B|||
3187|023|H|HOW TO USE:  This medication is given by injection into a vein by||
3187|024|H|a health care professional as directed by your doctor, usually 15||
3187|025|H|to 30 minutes before cancer treatment. The dosage is based on||
3187|026|H|your medical condition, body size, and response to treatment.||
3187|027|H|   To decrease the risk of side effects, drink plenty of fluids||
3187|028|H|while using this medication unless otherwise directed by your||
3187|029|H|doctor. Your doctor may direct you to lie down while receiving||
3187|030|H|this medication to decrease the chances of low blood pressure.||
3187|031|H|Also, if you are taking blood pressure medication, your doctor||
3187|032|H|may direct you to stop taking it for 1 day before receiving this||
3187|033|H|drug. Be sure to ask your doctor when to restart blood pressure||
3187|034|H|medication.||
3187|035|B|||
3187|036|S|SIDE EFFECTS:  Flushing, chills, unusual feelings of||
3187|037|S|warmth/coldness, blurred vision, dizziness, drowsiness, or||
3187|038|S|pain/redness/swelling at the injection site may occur. Nausea and||
3187|039|S|vomiting occur often and can be severe. Your doctor may prescribe||
3187|040|S|medication to prevent or relieve nausea and vomiting. Eating||
3187|041|S|several small meals, not eating before treatment, or limiting||
3187|042|S|activity may help lessen some of these effects. If any of these||
3187|043|S|effects last or get worse, tell your doctor or pharmacist||
3187|044|S|promptly.||
3187|045|S|   Remember that this medication has been prescribed because your||
3187|046|S|doctor has judged that the benefit to you is greater than the||
3187|047|S|risk of side effects. Many people using this medication do not||
3187|048|S|have serious side effects.||
3187|049|S|   Tell your doctor right away if you have any serious side||
3187|050|S|effects, including: fainting, fast/slow/irregular heartbeat,||
3187|051|S|muscle spasms, mental/mood changes, seizure.||
3187|052|S|   A very serious allergic reaction to this drug is rare.||
3187|053|S|However, get medical help right away if you notice any symptoms||
3187|054|S|of a serious allergic reaction, including: fever, swollen lymph||
3187|055|S|nodes, rash, itching/swelling (especially of the||
3187|056|S|face/tongue/throat), severe dizziness, trouble breathing.||
3187|057|S|   This is not a complete list of possible side effects. If you||
3187|058|S|notice other effects not listed above, contact your doctor or||
3187|059|S|pharmacist.||
3187|060|S|   In the US -||
3187|061|S|   Call your doctor for medical advice about side effects. You||
3187|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3187|063|S|www.fda.gov/medwatch.||
3187|064|S|   In Canada - Call your doctor for medical advice about side||
3187|065|S|effects. You may report side effects to Health Canada at||
3187|066|S|1-866-234-2345.||
3187|067|B|||
3187|068|P|PRECAUTIONS:  Before receiving amifostine, tell your doctor or||
3187|069|P|pharmacist if you are allergic to it; or if you have any other||
3187|070|P|allergies. This product may contain inactive ingredients, which||
3187|071|P|can cause allergic reactions or other problems. Talk to your||
3187|072|P|pharmacist for more details.||
3187|073|P|   Before using this medication, tell your doctor or pharmacist||
3187|074|P|your medical history, especially of: low/high blood pressure,||
3187|075|P|dehydration, heart disease (such as irregular heartbeat, heart||
3187|076|P|failure), kidney disease, previous stroke.||
3187|077|P|   This drug may make you dizzy or drowsy or blur your vision.||
3187|078|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3187|079|P|drowsy. Do not drive, use machinery, or do anything that needs||
3187|080|P|alertness or clear vision until you can do it safely. Limit||
3187|081|P|alcoholic beverages. Talk to your doctor if you are using||
3187|082|P|marijuana (cannabis).||
3187|083|P|   Before having surgery, tell your doctor or dentist about all||
3187|084|P|the products you use (including prescription drugs,||
3187|085|P|nonprescription drugs, and herbal products).||
3187|086|P|   Tell your doctor if you are pregnant or plan to become||
3187|087|P|pregnant. Since amifostine is used with anti-cancer treatments||
3187|088|P|which may harm an unborn baby, you should not become pregnant||
3187|089|P|during treatment. Ask about reliable forms of birth control while||
3187|090|P|using this medication with anti-cancer treatments. If you become||
3187|091|P|pregnant, talk to your doctor right away about the risks and||
3187|092|P|benefits of amifostine and the anti-cancer treatments.||
3187|093|P|   It is unknown if this medication passes into breast milk.||
3187|094|P|Because of possible risk to the infant, breastfeeding is not||
3187|095|P|recommended while using this medication. Consult your doctor||
3187|096|P|before breastfeeding.||
3187|097|B|||
3187|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3187|099|I|medications work or increase your risk for serious side effects.||
3187|100|I|This document does not contain all possible drug interactions.||
3187|101|I|Keep a list of all the products you use (including||
3187|102|I|prescription/nonprescription drugs and herbal products) and share||
3187|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
3187|104|I|the dosage of any medicines without your doctor's approval.||
3187|105|I|   Tell your doctor or pharmacist if you are taking other||
3187|106|I|products that cause drowsiness such as opioid pain or cough||
3187|107|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3187|108|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3187|109|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3187|110|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
3187|111|I|diphenhydramine).||
3187|112|I|   Check the labels on all your medicines (such as allergy or||
3187|113|I|cough-and-cold products) because they may contain ingredients||
3187|114|I|that cause drowsiness. Ask your pharmacist about using those||
3187|115|I|products safely.||
3187|116|B|||
3187|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3187|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3187|119|O|poison control center right away. US residents can call||
3187|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3187|121|B|||
3187|122|N|NOTES:  Lab and/or medical tests (such as blood pressure, serum||
3187|123|N|calcium levels) should be done while you are using this||
3187|124|N|medication. Keep all medical and lab appointments. Consult your||
3187|125|N|doctor for more details.||
3187|126|B|||
3187|127|D|MISSED DOSE:  It is important to get each dose of this medication||
3187|128|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
3187|129|D|right away for a new dosing schedule.||
3187|130|B|||
3187|131|R|STORAGE:  Not applicable. This medication is given in a hospital||
3187|132|R|or clinic and will not be stored at home.||
3187|133|B|||
3187|134|A|Information last revised May 2024.||
3187|135|A|Copyright(c) 2025 First Databank, Inc.||
3187|136|B|||
3194|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3194|002|Z|does NOT have all possible information about this product. This||
3194|003|Z|information does not assure that this product is safe, effective,||
3194|004|Z|or appropriate for you. This information is not individual||
3194|005|Z|medical advice and does not substitute for the advice of your||
3194|006|Z|health care professional. Always ask your health care||
3194|007|Z|professional for complete information about this product and your||
3194|008|Z|specific health needs.||
3194|009|B|||
3194|010|T|MEPERIDINE - INJECTION||
3194|011|F|(me-PER-i-deen)||
3194|012|B|||
3194|013|C|COMMON BRAND NAME(S): Demerol||
3194|014|B|||
3194|015|W|WARNING:  Meperidine has a risk for abuse and addiction, which||
3194|016|W|can lead to overdose and death. Meperidine may also cause severe,||
3194|017|W|possibly fatal, breathing problems. To lower your risk, your||
3194|018|W|doctor should have you use the smallest dose of meperidine that||
3194|019|W|works, and use it for the shortest possible time. See also How to||
3194|020|W|Use section for more information about addiction.||
3194|021|W|   Ask your doctor or pharmacist if you should have medication||
3194|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
3194|023|W|Teach your family or household members about the signs of an||
3194|024|W|opioid overdose and how to treat it.||
3194|025|W|   The risk for severe breathing problems is higher when you||
3194|026|W|start this medication and after a dose increase, or if you use||
3194|027|W|the wrong dose/strength. Using this medication with alcohol or||
3194|028|W|other drugs that can cause drowsiness or breathing problems may||
3194|029|W|cause very serious side effects, including death. Also, other||
3194|030|W|medications can affect the removal of meperidine from your body,||
3194|031|W|which may affect how meperidine works. Be sure you know how to||
3194|032|W|use meperidine and what other drugs you should avoid using with||
3194|033|W|it. See also Drug Interactions section. Get medical help right||
3194|034|W|away if any of these very serious side effects occur:||
3194|035|W|slow/shallow breathing, unusual lightheadedness, severe||
3194|036|W|drowsiness/dizziness, difficulty waking up.||
3194|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
3194|038|W|or abuse. If someone accidentally swallows this drug, get medical||
3194|039|W|help right away.||
3194|040|W|   Before using this medication, women of childbearing age should||
3194|041|W|talk with their doctor(s) about the risks and benefits. Tell your||
3194|042|W|doctor if you are pregnant or if you plan to become pregnant.||
3194|043|W|During pregnancy, this medication should be used only when||
3194|044|W|clearly needed. It may slightly increase the risk of birth||
3194|045|W|defects if used during the first two months of pregnancy. Also,||
3194|046|W|using it for a long time or in high doses near the expected||
3194|047|W|delivery date may harm the unborn baby. To lessen the risk, take||
3194|048|W|the smallest effective dose for the shortest possible time.||
3194|049|W|Babies born to mothers who use this drug for a long time may||
3194|050|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
3194|051|W|doctor right away if you notice any symptoms in your newborn baby||
3194|052|W|such as crying that doesn't stop, slow/shallow breathing,||
3194|053|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
3194|054|W|difficulty gaining weight.||
3194|055|B|||
3194|056|U|USES:  Meperidine is used to help relieve moderate to severe||
3194|057|U|pain. It may also be used before and during surgery or other||
3194|058|U|procedures. Meperidine belongs to a class of drugs known as||
3194|059|U|opioid analgesics and is similar to morphine. It works in the||
3194|060|U|brain to change how your body feels and responds to pain.||
3194|061|U|   Meperidine should not be used to treat long-term or ongoing||
3194|062|U|pain. It should only be used to treat sudden episodes of moderate||
3194|063|U|to severe pain. See also Precautions section.||
3194|064|U|   This drug is not recommended for use in newborns due to an||
3194|065|U|increased risk of serious side effects. Ask the doctor or||
3194|066|U|pharmacist for details.||
3194|067|B|||
3194|068|H|HOW TO USE:  This medication is given by injection into a vein,||
3194|069|H|into a muscle, or under the skin as directed by your doctor. The||
3194|070|H|dosage is based on your medical condition, response to treatment,||
3194|071|H|and other medications you may be taking. Children's dosage is||
3194|072|H|also based on weight. Be sure to tell your doctor and pharmacist||
3194|073|H|about all the products you use (including prescription drugs,||
3194|074|H|nonprescription drugs, and herbal products). Do not increase your||
3194|075|H|dose or use this drug more often or for longer than prescribed||
3194|076|H|because your risk of side effects may increase. Properly stop the||
3194|077|H|medication when so directed.||
3194|078|H|   If you have nausea after using this medication, ask your||
3194|079|H|doctor or pharmacist about ways to decrease it (such as lying||
3194|080|H|down for 1 to 2 hours with as little head movement as possible).||
3194|081|H|   If you are giving this medication to yourself at home, learn||
3194|082|H|all preparation and usage instructions from your health care||
3194|083|H|professional. Before using, check this product for particles or||
3194|084|H|discoloration. If either is present, do not use the liquid. You||
3194|085|H|should be lying down when the injection is given to prevent side||
3194|086|H|effects such as dizziness. Before injecting each dose, clean the||
3194|087|H|injection site with rubbing alcohol. If injecting into a muscle||
3194|088|H|or under the skin, change the injection site each time to lessen||
3194|089|H|injury under the skin. Learn how to store and discard medical||
3194|090|H|supplies safely.||
3194|091|H|   Pain medications work best if they are used as the first signs||
3194|092|H|of pain occur. If you wait until the pain has worsened, the||
3194|093|H|medication may not work as well.||
3194|094|H|   Suddenly stopping this medication may cause withdrawal,||
3194|095|H|especially if you have used it for a long time or in high doses.||
3194|096|H|To prevent withdrawal, your doctor may lower your dose slowly.||
3194|097|H|Tell your doctor or pharmacist right away if you have any||
3194|098|H|withdrawal symptoms such as restlessness, mental/mood changes||
3194|099|H|(including anxiety, trouble sleeping, thoughts of suicide),||
3194|100|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
3194|101|H|aches, or sudden changes in behavior.||
3194|102|H|   When this medication is used for a long time, it may not work||
3194|103|H|as well. Talk with your doctor if this medication stops working||
3194|104|H|well.||
3194|105|H|   Though it helps many people, this medication may sometimes||
3194|106|H|cause addiction. This risk may be higher if you have a||
3194|107|H|mental/mood disorder or a substance use disorder (such as overuse||
3194|108|H|of or addiction to drugs/alcohol). Use this medication exactly as||
3194|109|H|prescribed to lower the risk of addiction. Ask your doctor or||
3194|110|H|pharmacist for more details.||
3194|111|H|   Tell your doctor if your pain does not get better or if it||
3194|112|H|gets worse, or if you have any new pain.||
3194|113|B|||
3194|114|S|SIDE EFFECTS:  See also Warning section.||
3194|115|S|   Nausea, vomiting, constipation, sweating, lightheadedness,||
3194|116|S|dizziness, drowsiness, or pain/redness at the injection site may||
3194|117|S|occur. If any of these effects last or get worse, tell your||
3194|118|S|doctor or pharmacist promptly.||
3194|119|S|   To prevent constipation, eat dietary fiber, drink enough||
3194|120|S|water, and exercise. You may also need to take a laxative. Ask||
3194|121|S|your pharmacist which type of laxative is right for you.||
3194|122|S|   To reduce the risk of dizziness and lightheadedness, get up||
3194|123|S|slowly when rising from a sitting or lying position.||
3194|124|S|   Remember that this medication has been prescribed because your||
3194|125|S|doctor has judged that the benefit to you is greater than the||
3194|126|S|risk of side effects. Many people using this medication do not||
3194|127|S|have serious side effects.||
3194|128|S|   Tell your doctor right away if you have any serious side||
3194|129|S|effects, including: interrupted breathing during sleep (sleep||
3194|130|S|apnea), mental/mood changes (such as agitation, confusion,||
3194|131|S|hallucinations), trouble swallowing, stomach/abdominal pain,||
3194|132|S|difficulty urinating, slow/irregular/fast heartbeat, shaking||
3194|133|S|(tremors), vision changes, signs of your adrenal glands not||
3194|134|S|working well (such as loss of appetite, unusual tiredness, weight||
3194|135|S|loss).||
3194|136|S|   Get medical help right away if you have any very serious side||
3194|137|S|effects, including: fainting, seizure, severe||
3194|138|S|drowsiness/difficulty waking up.||
3194|139|S|   This medication may increase serotonin and rarely cause a very||
3194|140|S|serious condition called serotonin syndrome/toxicity. The risk||
3194|141|S|increases if you are also taking other drugs that increase||
3194|142|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
3194|143|S|take (see Drug Interactions section). Get medical help right away||
3194|144|S|if you develop some of the following symptoms: fast heartbeat,||
3194|145|S|hallucinations, loss of coordination, severe dizziness, severe||
3194|146|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
3194|147|S|unusual agitation/restlessness.||
3194|148|S|   A very serious allergic reaction to this drug is rare.||
3194|149|S|However, get medical help right away if you notice any symptoms||
3194|150|S|of a serious allergic reaction, including: rash, itching/swelling||
3194|151|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3194|152|S|breathing.||
3194|153|S|   This is not a complete list of possible side effects. If you||
3194|154|S|notice other effects not listed above, contact your doctor or||
3194|155|S|pharmacist.||
3194|156|S|   In the US -||
3194|157|S|   Call your doctor for medical advice about side effects. You||
3194|158|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3194|159|S|www.fda.gov/medwatch.||
3194|160|S|   In Canada - Call your doctor for medical advice about side||
3194|161|S|effects. You may report side effects to Health Canada at||
3194|162|S|1-866-234-2345.||
3194|163|B|||
3194|164|P|PRECAUTIONS:  Before using meperidine, tell your doctor or||
3194|165|P|pharmacist if you are allergic to it; or if you have any other||
3194|166|P|allergies. This product may contain inactive ingredients, which||
3194|167|P|can cause allergic reactions or other problems. Talk to your||
3194|168|P|pharmacist for more details.||
3194|169|P|   Before using this medication, tell your doctor or pharmacist||
3194|170|P|your medical history, especially of: brain disorders (such as||
3194|171|P|head injury, tumor, seizures), breathing problems (such as||
3194|172|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
3194|173|P|gallbladder disease, kidney disease, liver disease, mental/mood||
3194|174|P|disorders (such as confusion, depression, thoughts of suicide),||
3194|175|P|personal or family history of a substance use disorder (such as||
3194|176|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
3194|177|P|problems (such as blockage, constipation, diarrhea due to||
3194|178|P|infection, paralytic ileus), disease of the pancreas||
3194|179|P|(pancreatitis), difficulty urinating (such as due to enlarged||
3194|180|P|prostate), a certain adrenal gland tumor (pheochromocytoma),||
3194|181|P|heart problems (such as fast/irregular heartbeat), sickle cell||
3194|182|P|anemia.||
3194|183|P|   Meperidine is usually used only for a short time. Repeated or||
3194|184|P|high doses may cause drug levels to build up in the body and||
3194|185|P|cause serious side effects such as seizures and shaking. Caution||
3194|186|P|is advised if this medication is used for conditions that require||
3194|187|P|long-term or high-dosage treatment (such as sickle cell anemia,||
3194|188|P|burns, cancer). Consult your doctor or pharmacist for details.||
3194|189|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3194|190|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3194|191|P|machinery, or do anything that needs alertness until you can do||
3194|192|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
3194|193|P|are using marijuana (cannabis).||
3194|194|P|   Before having surgery, tell your doctor or dentist about all||
3194|195|P|the products you use (including prescription drugs,||
3194|196|P|nonprescription drugs, and herbal products).||
3194|197|P|   Older adults may be more sensitive to the side effects of this||
3194|198|P|drug, especially confusion, dizziness, drowsiness, and||
3194|199|P|slow/shallow breathing.||
3194|200|P|   Children may be more sensitive to the side effects of this||
3194|201|P|drug, especially severe drowsiness and slow/shallow breathing.||
3194|202|P|   During pregnancy, this medication should be used only when||
3194|203|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
3194|204|P|benefits with your doctor. (See also Warning section.)||
3194|205|P|   This drug passes into breast milk and may have undesirable||
3194|206|P|effects on a nursing infant. Tell the doctor right away if your||
3194|207|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
3194|208|P|breathing. Consult your doctor before breastfeeding.||
3194|209|B|||
3194|210|I|DRUG INTERACTIONS:  See also Warning section.||
3194|211|I|   Drug interactions may change how your medications work or||
3194|212|I|increase your risk for serious side effects. This document does||
3194|213|I|not contain all possible drug interactions. Keep a list of all||
3194|214|I|the products you use (including prescription/nonprescription||
3194|215|I|drugs and herbal products) and share it with your doctor and||
3194|216|I|pharmacist. Do not start, stop, or change the dosage of any||
3194|217|I|medicines without your doctor's approval.||
3194|218|I|   Some products that may interact with this drug include:||
3194|219|I|certain pain medications (mixed opioid agonist-antagonists such||
3194|220|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
3194|221|I|samidorphan.||
3194|222|I|   Taking MAO inhibitors with this medication may cause a serious||
3194|223|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
3194|224|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
3194|225|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
3194|226|I|selegiline, tranylcypromine) during treatment with this||
3194|227|I|medication. Most MAO inhibitors should also not be taken for two||
3194|228|I|weeks before treatment with this medication. Ask your doctor when||
3194|229|I|to start or stop taking this medication.||
3194|230|I|   The risk of serious side effects (such as slow/shallow||
3194|231|I|breathing, severe drowsiness/dizziness) may be increased if this||
3194|232|I|medication is used with other products that may also cause||
3194|233|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
3194|234|I|if you are taking other products such as other opioid pain or||
3194|235|I|cough relievers (such as codeine, hydrocodone), alcohol,||
3194|236|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
3194|237|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
3194|238|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
3194|239|I|cetirizine, diphenhydramine).||
3194|240|I|   Check the labels on all your medicines (such as allergy or||
3194|241|I|cough-and-cold products) because they may contain ingredients||
3194|242|I|that cause drowsiness. Ask your pharmacist about using those||
3194|243|I|products safely.||
3194|244|I|   The risk of serotonin syndrome/toxicity increases if you are||
3194|245|I|also taking other drugs that increase serotonin. Examples include||
3194|246|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
3194|247|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
3194|248|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
3194|249|I|serotonin syndrome/toxicity may be more likely when you start or||
3194|250|I|increase the dose of these drugs.||
3194|251|I|   Other medications can affect the removal of meperidine from||
3194|252|I|your body, which may affect how meperidine works. Examples||
3194|253|I|include azole antifungals (such as ketoconazole), macrolide||
3194|254|I|antibiotics (such as erythromycin), mifepristone, rifamycins||
3194|255|I|(such as rifabutin), ritonavir, drugs used to treat seizures||
3194|256|I|(such as carbamazepine, phenytoin), among others.||
3194|257|I|   This medication may interfere with certain lab tests (such as||
3194|258|I|amylase/lipase tests), possibly causing false test results. Make||
3194|259|I|sure lab personnel and all your doctors know you use this drug.||
3194|260|B|||
3194|261|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3194|262|O|as passing out or trouble breathing, give them naloxone or||
3194|263|O|nalmefene if available, then call 911. If the person is awake and||
3194|264|O|has no symptoms, call a poison control center right away. US||
3194|265|O|residents can call 1-800-222-1222. Canada residents can call||
3194|266|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
3194|267|O|breathing, severe drowsiness, coma.||
3194|268|B|||
3194|269|N|NOTES:  Do not share this medication with others. Sharing it is||
3194|270|N|against the law.||
3194|271|N|   This medication has been prescribed for your current condition||
3194|272|N|only. Do not use it later for another condition unless your||
3194|273|N|doctor directs you to do so. A different medication may be||
3194|274|N|necessary in that case.||
3194|275|B|||
3194|276|D|MISSED DOSE:  Not applicable.||
3194|277|B|||
3194|278|R|STORAGE:  Different products have different storage needs. Check||
3194|279|R|the product package for instructions on how to store your brand,||
3194|280|R|or ask your pharmacist. Keep all medications away from children||
3194|281|R|and pets.||
3194|282|R|   Do not flush medications down the toilet or pour them into a||
3194|283|R|drain unless instructed to do so. Properly discard this product||
3194|284|R|when it is expired or no longer needed. Consult your pharmacist||
3194|285|R|or local waste disposal company.||
3194|286|B|||
3194|287|A|Information last revised August 2025.||
3194|288|A|Copyright(c) 2025 First Databank, Inc.||
3194|289|B|||
3195|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3195|002|Z|does NOT have all possible information about this product. This||
3195|003|Z|information does not assure that this product is safe, effective,||
3195|004|Z|or appropriate for you. This information is not individual||
3195|005|Z|medical advice and does not substitute for the advice of your||
3195|006|Z|health care professional. Always ask your health care||
3195|007|Z|professional for complete information about this product and your||
3195|008|Z|specific health needs.||
3195|009|B|||
3195|010|T|PROMETHAZINE/DEXTROMETHORPHAN - ORAL||
3195|011|F|(pro-METH-uh-zeen/dex-trow-meth-OR-fan)||
3195|012|B|||
3195|013|W|WARNING:  Promethazine should not be used by children younger||
3195|014|W|than 2 years since it might cause serious (possibly fatal)||
3195|015|W|slow/shallow breathing. This problem has occurred even with||
3195|016|W|normal doses in this age group. The lowest effective dosage||
3195|017|W|should be used, and other drugs that affect breathing should be||
3195|018|W|avoided. Get medical help right away in the unlikely event that||
3195|019|W|slow/shallow breathing occurs. Promethazine should not be used by||
3195|020|W|children with liver disease (including possible Reyes syndrome).||
3195|021|B|||
3195|022|U|USES:  This combination medication is used to temporarily treat||
3195|023|U|runny nose, coughing, and sneezing caused by the common cold,||
3195|024|U|allergies, hay fever, and other breathing illnesses. Promethazine||
3195|025|U|is a phenothiazine that works like an antihistamine. It blocks||
3195|026|U|the effects of a certain natural substance (histamine), which||
3195|027|U|causes allergy symptoms. It also has a drying effect.||
3195|028|U|Dextromethorphan belongs to a class of drugs known as cough||
3195|029|U|suppressants. It acts on a part of the brain (cough center) to||
3195|030|U|reduce the need to cough.||
3195|031|U|   This product is usually not used for ongoing cough from||
3195|032|U|smoking or long-term breathing problems (such as chronic||
3195|033|U|bronchitis, emphysema) unless directed by your doctor.||
3195|034|U|   Cough-and-cold products have not been shown to be safe or||
3195|035|U|effective in children younger than 6 years. Do not use this||
3195|036|U|product to treat cold symptoms in children younger than 6 years||
3195|037|U|unless specifically directed by the doctor. Some products (such||
3195|038|U|as long-acting tablets/capsules) are not recommended for use in||
3195|039|U|children younger than 12 years. Ask your doctor or pharmacist for||
3195|040|U|more details about using your product safely.||
3195|041|U|   These products do not cure or shorten the length of the common||
3195|042|U|cold and may cause serious side effects. To decrease the risk for||
3195|043|U|serious side effects, carefully follow all dosage directions. Do||
3195|044|U|not use this product to make a child sleepy. Do not give other||
3195|045|U|cough-and-cold medication that might contain the same or similar||
3195|046|U|ingredients (see also Drug Interactions section). Ask the doctor||
3195|047|U|or pharmacist about other ways to relieve cough and cold symptoms||
3195|048|U|(such as drinking enough fluids, using a humidifier or saline||
3195|049|U|nose drops/spray).||
3195|050|B|||
3195|051|H|HOW TO USE:  Take this medication by mouth with or without food||
3195|052|H|as directed by your doctor, usually every 4 to 6 hours as needed.||
3195|053|H|Since dosing recommendations may vary, carefully follow your||
3195|054|H|doctor's directions for taking this medication.||
3195|055|H|   The dosage is based on your age, medical condition, and||
3195|056|H|response to treatment. Carefully measure the dose using a special||
3195|057|H|measuring device/spoon. Do not use a household spoon because you||
3195|058|H|may not get the correct dose.||
3195|059|H|   Drink plenty of fluids while you are using this medication||
3195|060|H|unless otherwise directed by your doctor. The fluid will help||
3195|061|H|loosen the mucus in your lungs.||
3195|062|H|   Improper use of this medication (abuse) may result in serious||
3195|063|H|harm (such as brain damage, seizure, death). Do not increase your||
3195|064|H|dose, take it more often, or use it for a longer time than||
3195|065|H|directed.||
3195|066|H|   Tell your doctor if your cough lasts, returns, or gets worse||
3195|067|H|after 7 days or if it is accompanied by headache that doesn't go||
3195|068|H|away, fever, severe sore throat, or rash.||
3195|069|B|||
3195|070|S|SIDE EFFECTS:  Drowsiness, dizziness, blurred vision, nausea,||
3195|071|S|constipation, or dry mouth may occur. If any of these effects||
3195|072|S|last or get worse, notify your doctor or pharmacist promptly.||
3195|073|S|   To reduce the risk of dizziness and lightheadedness, get up||
3195|074|S|slowly when rising from a sitting or lying position.||
3195|075|S|   If you are very sleepy or have difficulty waking up after||
3195|076|S|using this medication, stop taking this medication and talk to||
3195|077|S|your doctor or pharmacist right away. Your dosage may need to be||
3195|078|S|lower.||
3195|079|S|   Remember that this medication has been prescribed because your||
3195|080|S|doctor has judged that the benefit to you is greater than the||
3195|081|S|risk of side effects. Many people using this medication do not||
3195|082|S|have serious side effects.||
3195|083|S|   Tell your doctor right away if you have any serious side||
3195|084|S|effects, including: decreased coordination, difficulty urinating,||
3195|085|S|shaking (tremor), mental/mood changes (such as nervousness,||
3195|086|S|excitement, irritability, confusion, hallucinations),||
3195|087|S|abnormal/uncontrolled movements (such as fixed upward stare, neck||
3195|088|S|twisting, tongue movements), slow heartbeat, fainting.||
3195|089|S|   Get medical help right away if you have any very serious side||
3195|090|S|effects, including: slow/shallow breathing, seizures.||
3195|091|S|   This medication may rarely cause a very serious condition||
3195|092|S|called neuroleptic malignant syndrome (NMS). Get medical help||
3195|093|S|right away if you have any of the following symptoms: fever,||
3195|094|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
3195|095|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
3195|096|S|signs of kidney problems (such as change in the amount of urine).||
3195|097|S|   A very serious allergic reaction to this drug is rare.||
3195|098|S|However, get medical help right away if you notice any symptoms||
3195|099|S|of a serious allergic reaction, including: rash, itching/swelling||
3195|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3195|101|S|breathing.||
3195|102|S|   This is not a complete list of possible side effects. If you||
3195|103|S|notice other effects not listed above, contact your doctor or||
3195|104|S|pharmacist.||
3195|105|S|   In the US -||
3195|106|S|   Call your doctor for medical advice about side effects. You||
3195|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3195|108|S|www.fda.gov/medwatch.||
3195|109|S|   In Canada - Call your doctor for medical advice about side||
3195|110|S|effects. You may report side effects to Health Canada at||
3195|111|S|1-866-234-2345.||
3195|112|B|||
3195|113|P|PRECAUTIONS:  See also Warning section.||
3195|114|P|   Before taking this medication, tell your doctor or pharmacist||
3195|115|P|if you are allergic to promethazine or to dextromethorphan; or to||
3195|116|P|any other phenothiazines (such as prochlorperazine); or if you||
3195|117|P|have any other allergies. This product may contain inactive||
3195|118|P|ingredients, which can cause allergic reactions or other||
3195|119|P|problems. Talk to your pharmacist for more details.||
3195|120|P|   Before using this medication, tell your doctor or pharmacist||
3195|121|P|your medical history, especially of: breathing problems (such as||
3195|122|P|asthma, emphysema, sleep apnea), heart problems (such as||
3195|123|P|slow/irregular heartbeat, chest pain), liver problems, difficulty||
3195|124|P|urinating (such as due to an enlarged prostate), stomach/bowel||
3195|125|P|problems (such as blockage, ulcer), high blood pressure,||
3195|126|P|diabetes, a certain eye problem (glaucoma), seizures,||
3195|127|P|blood/immune system problems (such as bone marrow depression).||
3195|128|P|   This drug may make you dizzy or drowsy or blur your vision.||
3195|129|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3195|130|P|drowsy. Do not drive, use machinery, or do anything that needs||
3195|131|P|alertness or clear vision until you can do it safely. Children||
3195|132|P|should be supervised during bicycle riding and other possibly||
3195|133|P|hazardous activities to avoid injury. Limit alcoholic beverages.||
3195|134|P|Talk to your doctor if you are using marijuana (cannabis).||
3195|135|P|   This medication may make you more sensitive to the sun. Limit||
3195|136|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
3195|137|P|sunscreen and wear protective clothing when outdoors. Tell your||
3195|138|P|doctor right away if you get sunburned or have skin||
3195|139|P|blisters/redness.||
3195|140|P|   Liquid forms of this medication may contain sugar, alcohol, or||
3195|141|P|aspartame. Caution is advised if you have diabetes, liver||
3195|142|P|disease, phenylketonuria (PKU), or any other condition that||
3195|143|P|requires you to limit/avoid these substances in your diet. Ask||
3195|144|P|your doctor or pharmacist about using this product safely.||
3195|145|P|   Before having surgery or procedures such as X-rays with dye,||
3195|146|P|tell your doctor or dentist about all the products you use||
3195|147|P|(including prescription drugs, nonprescription drugs, and herbal||
3195|148|P|products).||
3195|149|P|   Children may be more sensitive to the side effects of this||
3195|150|P|drug, especially slowed breathing and uncontrolled movements (see||
3195|151|P|also Warning section). Children may also experience excitability||
3195|152|P|rather than drowsiness. Special caution should be taken in||
3195|153|P|children with a family history of sudden infant death syndrome||
3195|154|P|(SIDS), those who have a severe loss of fluid (dehydration), and||
3195|155|P|those who are hard to wake up from sleep.||
3195|156|P|   Older adults may be more sensitive to the side effects of this||
3195|157|P|drug, especially drowsiness, confusion, constipation, or trouble||
3195|158|P|urinating. Drowsiness and confusion can increase the risk of||
3195|159|P|falling.||
3195|160|P|   During pregnancy, this medication should be used only if||
3195|161|P|clearly needed. Discuss the risks and benefits with your doctor.||
3195|162|P|   Dextromethorphan passes into breast milk. It is unknown if||
3195|163|P|promethazine passes into breast milk. Consult your doctor before||
3195|164|P|breastfeeding.||
3195|165|B|||
3195|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3195|167|I|medications work or increase your risk for serious side effects.||
3195|168|I|This document does not contain all possible drug interactions.||
3195|169|I|Keep a list of all the products you use (including||
3195|170|I|prescription/nonprescription drugs and herbal products) and share||
3195|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
3195|172|I|the dosage of any medicines without your doctor's approval.||
3195|173|I|   Some products that may interact with this drug include:||
3195|174|I|diphenhydramine or other antihistamines applied to the skin (such||
3195|175|I|as anti-itch cream, ointment, spray), metoclopramide, rolapitant.||
3195|176|I|   Taking certain MAO inhibitors with this medication may cause a||
3195|177|I|serious (possibly fatal) drug interaction. Avoid taking||
3195|178|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
3195|179|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
3195|180|I|tranylcypromine during treatment with this medication. Most MAO||
3195|181|I|inhibitors should also not be taken for two weeks before||
3195|182|I|treatment with this medication. Ask your doctor when to start or||
3195|183|I|stop taking this medication.||
3195|184|I|   The risk of serious side effects (such as slow/shallow||
3195|185|I|breathing, severe drowsiness/dizziness) may be increased if this||
3195|186|I|medication is taken with other products that may also cause||
3195|187|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
3195|188|I|if you are taking other products such as opioid pain or cough||
3195|189|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3195|190|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3195|191|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3195|192|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
3195|193|I|diphenhydramine).||
3195|194|I|   Check the labels on all your medicines (such as allergy or||
3195|195|I|cough-and-cold products) because they may contain ingredients||
3195|196|I|that cause drowsiness. Ask your pharmacist about using those||
3195|197|I|products safely.||
3195|198|I|   Dextromethorphan is available in both prescription and||
3195|199|I|nonprescription products. Check the labels of all your||
3195|200|I|medications to make sure you are not taking more than one product||
3195|201|I|containing dextromethorphan.||
3195|202|I|   This medication may interfere with certain lab tests (such as||
3195|203|I|urine pregnancy tests, skin allergy tests), possibly causing||
3195|204|I|false test results. Make sure lab personnel and all your doctors||
3195|205|I|know you use this drug.||
3195|206|B|||
3195|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3195|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3195|209|O|poison control center right away. US residents can call||
3195|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3195|211|O|Symptoms of overdose may include: severe drowsiness, inability to||
3195|212|O|wake up, slow/shallow breathing, slow heartbeat, hallucinations,||
3195|213|O|seizures.||
3195|214|B|||
3195|215|N|NOTES:  Do not share this medication with others.||
3195|216|N|   This medication has been prescribed for your current condition||
3195|217|N|only. Do not use it later for another condition unless told to do||
3195|218|N|so by your doctor. A different medication may be necessary in||
3195|219|N|those cases.||
3195|220|B|||
3195|221|D|MISSED DOSE:  If you are prescribed this medication on a regular||
3195|222|D|schedule and miss a dose, take it as soon as you remember. If it||
3195|223|D|is near the time of the next dose, skip the missed dose. Take||
3195|224|D|your next dose at the regular time. Do not double the dose to||
3195|225|D|catch up.||
3195|226|B|||
3195|227|R|STORAGE:  Store at room temperature away from light and moisture.||
3195|228|R|Do not store in the bathroom. Keep all medications away from||
3195|229|R|children and pets.||
3195|230|R|   Do not flush medications down the toilet or pour them into a||
3195|231|R|drain unless instructed to do so. Properly discard this product||
3195|232|R|when it is expired or no longer needed. Consult your pharmacist||
3195|233|R|or local waste disposal company.||
3195|234|B|||
3195|235|A|Information last revised July 2025.||
3195|236|A|Copyright(c) 2025 First Databank, Inc.||
3195|237|B|||
3196|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3196|002|Z|does NOT have all possible information about this product. This||
3196|003|Z|information does not assure that this product is safe, effective,||
3196|004|Z|or appropriate for you. This information is not individual||
3196|005|Z|medical advice and does not substitute for the advice of your||
3196|006|Z|health care professional. Always ask your health care||
3196|007|Z|professional for complete information about this product and your||
3196|008|Z|specific health needs.||
3196|009|B|||
3196|010|T|CIPROFLOXACIN/DEXAMETHASONE SUSPENSION - OTIC||
3196|011|F|(SIP-roe-FLOX-a-sin/dex-uh-METH-uh-sown)||
3196|012|B|||
3196|013|C|COMMON BRAND NAME(S): Ciprodex||
3196|014|B|||
3196|015|U|USES:  This medication is used to treat bacterial ear infections.||
3196|016|U|It is used to treat middle ear infections in children with ear||
3196|017|U|tubes, as well as outer ear infections (also known as swimmer's||
3196|018|U|ear) in children and adults. This medication contains a||
3196|019|U|combination of ciprofloxacin (a quinolone-type antibiotic) and||
3196|020|U|dexamethasone (an anti-inflammatory corticosteroid). This ear||
3196|021|U|drop works by stopping the growth of bacteria and reducing ear||
3196|022|U|swelling and discomfort.||
3196|023|U|   This medication treats only bacterial ear infections. It will||
3196|024|U|not work for other types of ear infections. Unnecessary use or||
3196|025|U|overuse of any antibiotic can lead to its decreased||
3196|026|U|effectiveness.||
3196|027|B|||
3196|028|H|HOW TO USE:  Read the Patient Information Leaflet and||
3196|029|H|Instructions for Use if available from your pharmacist before you||
3196|030|H|start using this medication and each time you get a refill. If||
3196|031|H|you have any questions, ask your doctor or pharmacist.||
3196|032|H|   Use this medication in the infected ear as directed by your||
3196|033|H|doctor, usually twice daily (every 12 hours). Use in the ear||
3196|034|H|only. Do not use in the eyes. The ear canal should be clean and||
3196|035|H|dry before using this medication.||
3196|036|H|   To make sure that the right amount of medication is given, and||
3196|037|H|to avoid touching the ear with the dropper, have another person||
3196|038|H|give the drops if possible. To lower the risk of dizziness, hold||
3196|039|H|the container in your hand for a few minutes in order to warm it.||
3196|040|H|   To apply ear drops, wash your hands first. To avoid||
3196|041|H|contamination, do not touch the dropper tip or let it touch your||
3196|042|H|ear or any other surface. Shake the container well before using.||
3196|043|H|   When treating middle ear infections in children with ear||
3196|044|H|tubes, the child should lie down with the treated ear upward.||
3196|045|H|Hold the dropper directly over the ear, and place the prescribed||
3196|046|H|number of drops into the ear canal. Next gently press down 5||
3196|047|H|times in a pumping motion on the cartilage that partially covers||
3196|048|H|the opening to the ear. This will allow the medicine to pass||
3196|049|H|through the tube in the eardrum and into the middle ear. Keep the||
3196|050|H|head tilted with the treated ear upward for at least 1 minute or||
3196|051|H|insert a soft cotton plug if so directed.||
3196|052|H|   When treating outer ear infections, the patient should lie||
3196|053|H|down with the treated ear upward. Hold the dropper directly over||
3196|054|H|the ear, and place the prescribed number of drops into the ear||
3196|055|H|canal. While placing the drops into the ear of an adult, the||
3196|056|H|earlobe should be gently pulled up and back to allow the drops to||
3196|057|H|flow down into the ear canal. For children, gently pull the||
3196|058|H|earlobe down and back. Keep the head tilted with the treated ear||
3196|059|H|upward for at least 1 minute or insert a soft cotton plug if so||
3196|060|H|directed.||
3196|061|H|   Repeat the above steps for the other ear if so directed. Do||
3196|062|H|not rinse the dropper. Replace the cap after use.||
3196|063|H|   Use this medication regularly in order to get the most benefit||
3196|064|H|from it. To help you remember, use it at the same times each day.||
3196|065|H|Continue to use this medication for the full time prescribed,||
3196|066|H|even if symptoms disappear after a few days. Stopping the||
3196|067|H|medication too early may result in a return of the infection.||
3196|068|H|   Tell your doctor if your condition lasts or gets worse after 7||
3196|069|H|days of treatment. Report any fluid you find in the ear after||
3196|070|H|treatment is completed.||
3196|071|B|||
3196|072|S|SIDE EFFECTS:  Discomfort, pain, or itching in the ear may occur.||
3196|073|S|If any of these effects last or get worse, tell your doctor or||
3196|074|S|pharmacist promptly.||
3196|075|S|   Remember that this medication has been prescribed because your||
3196|076|S|doctor has judged that the benefit to you is greater than the||
3196|077|S|risk of side effects. Many people using this medication do not||
3196|078|S|have serious side effects.||
3196|079|S|   Use of this medication for prolonged or repeated periods may||
3196|080|S|result in a new fungal ear infection. Do not use this medication||
3196|081|S|for longer than prescribed. Contact your doctor if you notice new||
3196|082|S|or worsening symptoms.||
3196|083|S|   A very serious allergic reaction to this drug is rare.||
3196|084|S|However, get medical help right away if you notice any symptoms||
3196|085|S|of a serious allergic reaction, including: rash, itching/swelling||
3196|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3196|087|S|breathing.||
3196|088|S|   This is not a complete list of possible side effects. If you||
3196|089|S|notice other effects not listed above, contact your doctor or||
3196|090|S|pharmacist.||
3196|091|S|   In the US -||
3196|092|S|   Call your doctor for medical advice about side effects. You||
3196|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3196|094|S|www.fda.gov/medwatch.||
3196|095|S|   In Canada - Call your doctor for medical advice about side||
3196|096|S|effects. You may report side effects to Health Canada at||
3196|097|S|1-866-234-2345.||
3196|098|B|||
3196|099|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
3196|100|P|pharmacist if you are allergic to ciprofloxacin or dexamethasone;||
3196|101|P|or to quinolone antibiotics (such as levofloxacin); or if you||
3196|102|P|have any other allergies. This product may contain inactive||
3196|103|P|ingredients (such as preservatives like benzalkonium chloride),||
3196|104|P|which can cause allergic reactions or other problems. Talk to||
3196|105|P|your pharmacist for more details.||
3196|106|P|   Before using this medication, tell your doctor or pharmacist||
3196|107|P|your medical history, especially of: ear infections caused by a||
3196|108|P|fungus or virus (such as herpes simplex).||
3196|109|P|   Before having surgery, tell your doctor or dentist about all||
3196|110|P|the products you use (including prescription drugs,||
3196|111|P|nonprescription drugs, and herbal products).||
3196|112|P|   During pregnancy, this medication should be used only when||
3196|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
3196|114|P|   It is unknown if this medication passes into breast milk.||
3196|115|P|Consult your doctor before breastfeeding.||
3196|116|B|||
3196|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3196|118|I|medications work or increase your risk for serious side effects.||
3196|119|I|This document does not contain all possible drug interactions.||
3196|120|I|Keep a list of all the products you use (including||
3196|121|I|prescription/nonprescription drugs and herbal products) and share||
3196|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
3196|123|I|the dosage of any medicines without your doctor's approval.||
3196|124|B|||
3196|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3196|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3196|127|O|poison control center right away. US residents can call||
3196|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
3196|129|O|medicine may be harmful if swallowed.||
3196|130|B|||
3196|131|N|NOTES:  Do not share this medication with others.||
3196|132|N|   This medication has been prescribed for your current condition||
3196|133|N|only. Throw away the unused medication after treatment is||
3196|134|N|completed. Do not use it later for another infection unless your||
3196|135|N|doctor tells you to.||
3196|136|N|   Contact your doctor if, after treatment with this medication,||
3196|137|N|you develop 2 or more ear infections in a 6-month period. You may||
3196|138|N|require further evaluation and a different kind of treatment.||
3196|139|N|   It is important to keep the infected ear(s) clean and dry. Try||
3196|140|N|not to get the infected ear(s) wet when bathing. Avoid swimming||
3196|141|N|unless your doctor tells you otherwise.||
3196|142|B|||
3196|143|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3196|144|D|If it is near the time of the next dose, skip the missed dose.||
3196|145|D|Use your next dose at the regular time. Do not double the dose to||
3196|146|D|catch up.||
3196|147|B|||
3196|148|R|STORAGE:  Store at room temperature away from light. Do not||
3196|149|R|freeze. Keep all medications away from children and pets.||
3196|150|R|   Do not flush medications down the toilet or pour them into a||
3196|151|R|drain unless instructed to do so. Properly discard this product||
3196|152|R|when it is expired or no longer needed. Consult your pharmacist||
3196|153|R|or local waste disposal company.||
3196|154|B|||
3196|155|A|Information last revised May 2024.||
3196|156|A|Copyright(c) 2025 First Databank, Inc.||
3196|157|B|||
3202|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3202|002|Z|does NOT have all possible information about this product. This||
3202|003|Z|information does not assure that this product is safe, effective,||
3202|004|Z|or appropriate for you. This information is not individual||
3202|005|Z|medical advice and does not substitute for the advice of your||
3202|006|Z|health care professional. Always ask your health care||
3202|007|Z|professional for complete information about this product and your||
3202|008|Z|specific health needs.||
3202|009|B|||
3202|010|T|ACETOHYDROXAMIC ACID - ORAL||
3202|011|F|(a-SEET-oh-HYE-drox-AM-ik AS-id)||
3202|012|B|||
3202|013|C|COMMON BRAND NAME(S): Lithostat||
3202|014|B|||
3202|015|U|USES:  This medication is used with antibiotics and/or surgery to||
3202|016|U|treat types of bladder infections that are caused by certain||
3202|017|U|bacteria. These bacteria cause the level of ammonia in the urine||
3202|018|U|to become too high. This effect can lead to a certain type of||
3202|019|U|kidney stone (struvite). This medication works by stopping the||
3202|020|U|bacteria from making the ammonia. The decreased levels of ammonia||
3202|021|U|can slow the growth of the kidney stones and make the antibiotic||
3202|022|U|work better on your infection.||
3202|023|B|||
3202|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3202|025|H|from your pharmacist before you start using acetohydroxamic acid||
3202|026|H|and each time you get a refill. If you have any questions, ask||
3202|027|H|your doctor or pharmacist.||
3202|028|H|   Take this medication by mouth on an empty stomach as directed||
3202|029|H|by your doctor, usually 3 to 4 times daily.||
3202|030|H|   Dosage is based on your medical condition, weight, and||
3202|031|H|response to treatment.||
3202|032|H|   Use this medication regularly to get the most benefit from it.||
3202|033|H|To help you remember, use it at the same times each day.||
3202|034|H|   Tell your doctor if your condition lasts or gets worse.||
3202|035|B|||
3202|036|S|SIDE EFFECTS:  Headache, nausea, vomiting, stomach upset, unusual||
3202|037|S|hair loss, or loss of appetite may occur. If any of these effects||
3202|038|S|last or get worse, tell your doctor or pharmacist promptly.||
3202|039|S|   Remember that this medication has been prescribed because your||
3202|040|S|doctor has judged that the benefit to you is greater than the||
3202|041|S|risk of side effects. Many people using this medication do not||
3202|042|S|have serious side effects.||
3202|043|S|   Tell your doctor right away if you have any serious side||
3202|044|S|effects, including: fast/pounding heartbeat, unusual tiredness,||
3202|045|S|weakness, dark urine, mental/mood changes (such as nervousness,||
3202|046|S|depression), shaking (tremor), pain/redness/swelling of arms or||
3202|047|S|legs, easy bruising/bleeding, signs of infection (such as sore||
3202|048|S|throat that doesn't go away, fever, chills).||
3202|049|S|   Get medical help right away if you have any very serious side||
3202|050|S|effects, including: chest pain.||
3202|051|S|   A very serious allergic reaction to this drug is rare.||
3202|052|S|However, get medical help right away if you notice any symptoms||
3202|053|S|of a serious allergic reaction, including: rash, itching/swelling||
3202|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3202|055|S|breathing.||
3202|056|S|   This is not a complete list of possible side effects. If you||
3202|057|S|notice other effects not listed above, contact your doctor or||
3202|058|S|pharmacist.||
3202|059|S|   In the US -||
3202|060|S|   Call your doctor for medical advice about side effects. You||
3202|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3202|062|S|www.fda.gov/medwatch.||
3202|063|S|   In Canada - Call your doctor for medical advice about side||
3202|064|S|effects. You may report side effects to Health Canada at||
3202|065|S|1-866-234-2345.||
3202|066|B|||
3202|067|P|PRECAUTIONS:  Before taking acetohydroxamic acid, tell your||
3202|068|P|doctor or pharmacist if you are allergic to it; or if you have||
3202|069|P|any other allergies. This product may contain inactive||
3202|070|P|ingredients, which can cause allergic reactions or other||
3202|071|P|problems. Talk to your pharmacist for more details.||
3202|072|P|   Before using this medication, tell your doctor or pharmacist||
3202|073|P|your medical history, especially of: kidney disease, blood clots,||
3202|074|P|blood/bone marrow disorders (such as anemia), regular alcohol||
3202|075|P|use.||
3202|076|P|   Avoid alcoholic beverages while taking this medication because||
3202|077|P|alcohol with acetohydroxamic acid may cause a skin reaction (such||
3202|078|P|as flushing, redness, warmth, tingling). The reaction usually||
3202|079|P|appears 30 to 45 minutes after having alcohol and disappears 30||
3202|080|P|to 60 minutes later.||
3202|081|P|   This medication must not be used during pregnancy. It may harm||
3202|082|P|an unborn baby. It is important to prevent pregnancy while taking||
3202|083|P|this medication. Consult your doctor for more details and to||
3202|084|P|discuss the use of reliable forms of birth control (such as||
3202|085|P|condoms, birth control pills) while taking this medication. If||
3202|086|P|you become pregnant or think you may be pregnant, tell your||
3202|087|P|doctor right away.||
3202|088|P|   This drug may pass into breast milk and may have undesirable||
3202|089|P|effects on a nursing infant. Consult your doctor before||
3202|090|P|breastfeeding.||
3202|091|B|||
3202|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3202|093|I|medications work or increase your risk for serious side effects.||
3202|094|I|This document does not contain all possible drug interactions.||
3202|095|I|Keep a list of all the products you use (including||
3202|096|I|prescription/nonprescription drugs and herbal products) and share||
3202|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
3202|098|I|the dosage of any medicines without your doctor's approval.||
3202|099|I|   Some products that may interact with this drug are:||
3202|100|I|iron-containing products taken by mouth (such as supplements,||
3202|101|I|multivitamins).||
3202|102|B|||
3202|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3202|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3202|105|O|poison control center right away. US residents can call||
3202|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3202|107|O|Symptoms of overdose may include: loss of appetite, weakness,||
3202|108|O|unusual tiredness, nausea, vomiting, shaking (tremor).||
3202|109|B|||
3202|110|N|NOTES:  Do not share this medication with others.||
3202|111|N|   Lab and/or medical tests (such as complete blood count,||
3202|112|N|liver/kidney function) should be done while you are taking this||
3202|113|N|medication. Keep all medical and lab appointments. Consult your||
3202|114|N|doctor for more details.||
3202|115|B|||
3202|116|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3202|117|D|remember. If it is near the time of the next dose, skip the||
3202|118|D|missed dose. Take your next dose at the regular time. Do not||
3202|119|D|double the dose to catch up.||
3202|120|B|||
3202|121|R|STORAGE:  Store at room temperature away from light and moisture.||
3202|122|R|Do not store in the bathroom. Keep all medications away from||
3202|123|R|children and pets.||
3202|124|R|   Do not flush medications down the toilet or pour them into a||
3202|125|R|drain unless instructed to do so. Properly discard this product||
3202|126|R|when it is expired or no longer needed. Consult your pharmacist||
3202|127|R|or local waste disposal company.||
3202|128|B|||
3202|129|A|Information last revised May 2025.||
3202|130|A|Copyright(c) 2025 First Databank, Inc.||
3202|131|B|||
3204|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3204|002|Z|does NOT have all possible information about this product. This||
3204|003|Z|information does not assure that this product is safe, effective,||
3204|004|Z|or appropriate for you. This information is not individual||
3204|005|Z|medical advice and does not substitute for the advice of your||
3204|006|Z|health care professional. Always ask your health care||
3204|007|Z|professional for complete information about this product and your||
3204|008|Z|specific health needs.||
3204|009|B|||
3204|010|T|DOXYLAMINE/PYRIDOXINE DELAYED-RELEASE - ORAL||
3204|011|F|(dox-ILL-uh-meen/pir-id-OX-een)||
3204|012|B|||
3204|013|C|COMMON BRAND NAME(S): Diclegis||
3204|014|B|||
3204|015|U|USES:  This combination medication (doxylamine with pyridoxine)||
3204|016|U|is used to prevent or reduce nausea and vomiting caused by||
3204|017|U|pregnancy. Decreasing nausea and vomiting may improve your health||
3204|018|U|and nutrition during pregnancy. Doxylamine is an antihistamine||
3204|019|U|that is thought to work by affecting certain natural substances||
3204|020|U|(acetylcholine, serotonin) in your body or by acting directly on||
3204|021|U|certain parts of the brain. Pyridoxine is a B vitamin that is||
3204|022|U|important for good health. Most people get enough pyridoxine in||
3204|023|U|their diet, but certain health conditions (such as pregnancy,||
3204|024|U|poor diet, alcoholism) can result in a lack of this vitamin.||
3204|025|B|||
3204|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3204|027|H|from your pharmacist before you start taking this medication and||
3204|028|H|each time you get a refill. If you have any questions, ask your||
3204|029|H|doctor or pharmacist.||
3204|030|H|   Take this medication by mouth without food as directed by your||
3204|031|H|doctor. If this medication is taken with food, it may take longer||
3204|032|H|for it to start to work but will not decrease the effect.||
3204|033|H|   Swallow the medication whole with a full glass of water. Do||
3204|034|H|not crush, chew, or break the tablets.||
3204|035|H|   Dosage is based on your medical condition and response to||
3204|036|H|treatment. This medication is usually taken at bedtime to||
3204|037|H|decrease nausea and vomiting in the morning. If nausea lasts||
3204|038|H|during the day, additional doses may be prescribed by your||
3204|039|H|doctor. Talk with your doctor about your symptoms and the best||
3204|040|H|dose schedule for you. Do not take more than 4 tablets in a day.||
3204|041|H|   Do not stop using this medication or change your dose without||
3204|042|H|consulting your doctor. Some conditions may become worse when the||
3204|043|H|drug is suddenly stopped. Your dose may need to be gradually||
3204|044|H|decreased.||
3204|045|H|   Use this medication regularly to get the most benefit from it.||
3204|046|H|To help you remember, take it at the same times each day.||
3204|047|B|||
3204|048|S|SIDE EFFECTS:  Drowsiness, dizziness, blurred vision, stomach||
3204|049|S|upset, diarrhea, constipation, headache, and trouble sleeping may||
3204|050|S|occur. If any of these effects last or get worse, tell your||
3204|051|S|doctor or pharmacist promptly.||
3204|052|S|   Remember that this medication has been prescribed because your||
3204|053|S|doctor has judged that the benefit to you is greater than the||
3204|054|S|risk of side effects. Many people using this medication do not||
3204|055|S|have serious side effects.||
3204|056|S|   Tell your doctor right away if you have any serious side||
3204|057|S|effects, including: mental/mood changes (such as confusion,||
3204|058|S|irritability, nervousness), trouble urinating, easy||
3204|059|S|bruising/bleeding, fast/irregular heartbeat.||
3204|060|S|   Get medical help right away if you have any very serious side||
3204|061|S|effects, including: seizure.||
3204|062|S|   A very serious allergic reaction to this drug is rare.||
3204|063|S|However, get medical help right away if you notice any symptoms||
3204|064|S|of a serious allergic reaction, including: rash, itching/swelling||
3204|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3204|066|S|breathing.||
3204|067|S|   This is not a complete list of possible side effects. If you||
3204|068|S|notice other effects not listed above, contact your doctor or||
3204|069|S|pharmacist.||
3204|070|S|   In the US -||
3204|071|S|   Call your doctor for medical advice about side effects. You||
3204|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3204|073|S|www.fda.gov/medwatch.||
3204|074|S|   In Canada - Call your doctor for medical advice about side||
3204|075|S|effects. You may report side effects to Health Canada at||
3204|076|S|1-866-234-2345.||
3204|077|B|||
3204|078|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
3204|079|P|pharmacist if you are allergic to doxylamine or pyridoxine; or if||
3204|080|P|you have any other allergies. This product may contain inactive||
3204|081|P|ingredients, which can cause allergic reactions or other||
3204|082|P|problems. Talk to your pharmacist for more details.||
3204|083|P|   Before using this medication, tell your doctor or pharmacist||
3204|084|P|your medical history, especially of: breathing problems (such as||
3204|085|P|asthma, emphysema), eye problems (such as glaucoma), heart||
3204|086|P|problems, liver disease, seizures, stomach problems (such as||
3204|087|P|ulcers, blockage), urination problems (such as urinary||
3204|088|P|retention).||
3204|089|P|   This drug may make you dizzy or drowsy or blur your vision.||
3204|090|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3204|091|P|drowsy. Do not drive, use machinery, or do anything that needs||
3204|092|P|alertness or clear vision until you can do it safely. Avoid||
3204|093|P|alcoholic beverages. Talk to your doctor if you are using||
3204|094|P|marijuana (cannabis).||
3204|095|P|   This product is safe to use during pregnancy.||
3204|096|P|   Pyridoxine passes into breast milk. It is unknown if||
3204|097|P|doxylamine passes into breast milk. However, similar drugs pass||
3204|098|P|into breast milk. Doxylamine may have undesirable effects on a||
3204|099|P|nursing infant. Consult your doctor before breastfeeding.||
3204|100|B|||
3204|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3204|102|I|medications work or increase your risk for serious side effects.||
3204|103|I|This document does not contain all possible drug interactions.||
3204|104|I|Keep a list of all the products you use (including||
3204|105|I|prescription/nonprescription drugs and herbal products) and share||
3204|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
3204|107|I|the dosage of any medicines without your doctor's approval.||
3204|108|I|   Some products that may interact with this drug include:||
3204|109|I|altretamine, antihistamines applied to the skin (such as||
3204|110|I|diphenhydramine cream, ointment, spray).||
3204|111|I|   Tell your doctor or pharmacist if you are taking other||
3204|112|I|products that cause drowsiness such as opioid pain or cough||
3204|113|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3204|114|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3204|115|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3204|116|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
3204|117|I|diphenhydramine).||
3204|118|I|   Check the labels on all your medicines (such as allergy or||
3204|119|I|cough-and-cold products) because they may contain ingredients||
3204|120|I|that cause drowsiness. Ask your pharmacist about using those||
3204|121|I|products safely.||
3204|122|I|   This medication may interfere with certain lab tests (such as||
3204|123|I|urine drug screening tests), possibly causing false test results.||
3204|124|I|Make sure lab personnel and all your doctors know you use this||
3204|125|I|drug.||
3204|126|B|||
3204|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3204|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3204|129|O|poison control center right away. US residents can call||
3204|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3204|131|O|Symptoms of overdose may include: flushing, hallucinations,||
3204|132|O|weakness, shaking (tremor), muscle twitching, loss of||
3204|133|O|consciousness, seizures.||
3204|134|B|||
3204|135|N|NOTES:  Do not share this medication with others.||
3204|136|N|   Do not take for several days before allergy testing because||
3204|137|N|test results can be affected.||
3204|138|B|||
3204|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3204|140|D|remember. If it is near the time of the next dose, skip the||
3204|141|D|missed dose. Take your next dose at the regular time. Do not||
3204|142|D|double the dose to catch up.||
3204|143|B|||
3204|144|R|STORAGE:  Store at room temperature away from light and moisture.||
3204|145|R|Do not store in the bathroom. Keep all medications away from||
3204|146|R|children and pets.||
3204|147|R|   Do not flush medications down the toilet or pour them into a||
3204|148|R|drain unless instructed to do so. Properly discard this product||
3204|149|R|when it is expired or no longer needed. Consult your pharmacist||
3204|150|R|or local waste disposal company.||
3204|151|B|||
3204|152|A|Information last revised May 2024.||
3204|153|A|Copyright(c) 2025 First Databank, Inc.||
3204|154|B|||
3206|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3206|002|Z|does NOT have all possible information about this product. This||
3206|003|Z|information does not assure that this product is safe, effective,||
3206|004|Z|or appropriate for you. This information is not individual||
3206|005|Z|medical advice and does not substitute for the advice of your||
3206|006|Z|health care professional. Always ask your health care||
3206|007|Z|professional for complete information about this product and your||
3206|008|Z|specific health needs.||
3206|009|B|||
3206|010|T|BUTOCONAZOLE NITRATE CREAM - VAGINAL||
3206|011|F|(BUE-toe-KON-a-zole NYE-trate)||
3206|012|B|||
3206|013|C|COMMON BRAND NAME(S): Gynazole-1, Mycelex||
3206|014|B|||
3206|015|U|USES:  This medication is used to treat vaginal yeast infections.||
3206|016|U|Butoconazole reduces vaginal burning, itching, and discharge that||
3206|017|U|may occur with this condition. This medication is an azole||
3206|018|U|antifungal. It works by stopping the growth of yeast (fungus)||
3206|019|U|that causes the infection.||
3206|020|U|   If you have fever, chills, flu-like symptoms,||
3206|021|U|stomach/abdominal pain, or a bad-smelling vaginal discharge, do||
3206|022|U|not use this medication. Contact your doctor right away because||
3206|023|U|these may be signs of a more serious infection.||
3206|024|B|||
3206|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3206|026|H|from your pharmacist before you start using butoconazole, and||
3206|027|H|each time you get a refill. If you have any questions, ask your||
3206|028|H|doctor or pharmacist.||
3206|029|H|   This product is for vaginal use only. Wash your hands before||
3206|030|H|and after use. Avoid contact of this cream with your eyes. If it||
3206|031|H|gets into your eyes, wash them right away with plenty of water.||
3206|032|H|Call your doctor if eye irritation lasts.||
3206|033|H|   Use this product as directed by your doctor, usually given as||
3206|034|H|a single dose. Learn all preparation and usage instructions in||
3206|035|H|the product package. Lie on your back with your knees toward your||
3206|036|H|chest. Insert the applicator filled with medication into the||
3206|037|H|vagina as far as it will comfortably go. Slowly press the plunger||
3206|038|H|of the applicator in to apply the full dose of the cream.||
3206|039|H|   Do not use tampons or douches while using this medication.||
3206|040|H|Unscented sanitary napkins may be used for your menstrual period||
3206|041|H|or to protect your clothing from leakage of the medication.||
3206|042|H|   Tell your doctor if your condition does not get better or if||
3206|043|H|it returns within 2 months. You may need a different or||
3206|044|H|additional medication to treat your condition.||
3206|045|B|||
3206|046|S|SIDE EFFECTS:  Increased vaginal/urethral burning/itching/pain,||
3206|047|S|or mild abdominal cramps may occur. If any of these effects last||
3206|048|S|or get worse, tell your doctor or pharmacist promptly.||
3206|049|S|   Remember that this medication has been prescribed because your||
3206|050|S|doctor has judged that the benefit to you is greater than the||
3206|051|S|risk of side effects. Many people using this medication do not||
3206|052|S|have serious side effects.||
3206|053|S|   A very serious allergic reaction to this drug is rare.||
3206|054|S|However, get medical help right away if you notice any symptoms||
3206|055|S|of a serious allergic reaction, including: rash, itching/swelling||
3206|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3206|057|S|breathing.||
3206|058|S|   This is not a complete list of possible side effects. If you||
3206|059|S|notice other effects not listed above, contact your doctor or||
3206|060|S|pharmacist.||
3206|061|S|   In the US -||
3206|062|S|   Call your doctor for medical advice about side effects. You||
3206|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3206|064|S|www.fda.gov/medwatch.||
3206|065|S|   In Canada - Call your doctor for medical advice about side||
3206|066|S|effects. You may report side effects to Health Canada at||
3206|067|S|1-866-234-2345.||
3206|068|B|||
3206|069|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
3206|070|P|pharmacist if you are allergic to it; or to other azole||
3206|071|P|antifungal agents (such as clotrimazole, fluconazole); or if you||
3206|072|P|have any other allergies. This product may contain inactive||
3206|073|P|ingredients, which can cause allergic reactions or other||
3206|074|P|problems. Talk to your pharmacist for more details.||
3206|075|P|   Before using this medication, tell your doctor or pharmacist||
3206|076|P|your medical history, especially of: diabetes, immune system||
3206|077|P|problems (such as HIV-AIDS), frequent vaginal yeast infections||
3206|078|P|(more than 4 per year).||
3206|079|P|   Before having surgery, tell your doctor or dentist about all||
3206|080|P|the products you use (including prescription drugs,||
3206|081|P|nonprescription drugs, and herbal products).||
3206|082|P|   Ask your doctor whether you can have sexual intercourse while||
3206|083|P|using this product. This product may weaken rubber products (such||
3206|084|P|as latex condoms, diaphragms, cervical caps) and lead to failure.||
3206|085|P|This can result in pregnancy. Do not use these products during||
3206|086|P|treatment with this medication and for 3 days after treatment is||
3206|087|P|over. Consult your doctor about other forms of barrier||
3206|088|P|protection/birth control (such as polyurethane condoms) during||
3206|089|P|this time.||
3206|090|P|   During pregnancy, this medication should be used only when||
3206|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
3206|092|P|Pregnant women should use extra care when using the vaginal||
3206|093|P|applicator. Follow your doctor's instructions closely on how to||
3206|094|P|insert the medication using the applicator.||
3206|095|P|   It is unknown if this drug passes into breast milk. Consult||
3206|096|P|your doctor before breastfeeding.||
3206|097|B|||
3206|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3206|099|I|medications work or increase your risk for serious side effects.||
3206|100|I|This document does not contain all possible drug interactions.||
3206|101|I|Keep a list of all the products you use (including||
3206|102|I|prescription/nonprescription drugs and herbal products) and share||
3206|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
3206|104|I|the dosage of any medicines without your doctor's approval.||
3206|105|B|||
3206|106|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3206|107|O|has overdosed and has serious symptoms such as passing out or||
3206|108|O|trouble breathing, call 911. Otherwise, call a poison control||
3206|109|O|center right away. US residents can call 1-800-222-1222. Canada||
3206|110|O|residents can call 1-844-764-7669.||
3206|111|B|||
3206|112|N|NOTES:  Do not share this medication with others.||
3206|113|N|   To help prevent vaginal yeast infections, dry the genital area||
3206|114|N|thoroughly after showering, bathing, or swimming. Avoid wearing||
3206|115|N|tight jeans, nylon underwear, pantyhose, a wet bathing suit, or||
3206|116|N|damp/sweaty exercise clothes for long periods. Wear cotton||
3206|117|N|underwear, and change your underwear daily.||
3206|118|N|   This medication has been prescribed for your current condition||
3206|119|N|only. Do not use it later for another infection unless your||
3206|120|N|doctor tells you to.||
3206|121|N|   If your sexual partner experiences symptoms, they should||
3206|122|N|contact their doctor right away.||
3206|123|B|||
3206|124|D|MISSED DOSE:  Not applicable. This medication is usually given as||
3206|125|D|one dose only.||
3206|126|B|||
3206|127|R|STORAGE:  Store at room temperature. Keep all medications away||
3206|128|R|from children and pets.||
3206|129|R|   Do not flush medications down the toilet or pour them into a||
3206|130|R|drain unless instructed to do so. Properly discard this product||
3206|131|R|when it is expired or no longer needed. Consult your pharmacist||
3206|132|R|or local waste disposal company.||
3206|133|B|||
3206|134|A|Information last revised November 2024.||
3206|135|A|Copyright(c) 2025 First Databank, Inc.||
3206|136|B|||
3217|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3217|002|Z|does NOT have all possible information about this product. This||
3217|003|Z|information does not assure that this product is safe, effective,||
3217|004|Z|or appropriate for you. This information is not individual||
3217|005|Z|medical advice and does not substitute for the advice of your||
3217|006|Z|health care professional. Always ask your health care||
3217|007|Z|professional for complete information about this product and your||
3217|008|Z|specific health needs.||
3217|009|B|||
3217|010|T|GABAPENTIN SOLUTION - ORAL||
3217|011|F|(gab-uh-PEN-tin)||
3217|012|B|||
3217|013|C|COMMON BRAND NAME(S): Neurontin||
3217|014|B|||
3217|015|U|USES:  Gabapentin is used with other medications to prevent and||
3217|016|U|control seizures. It is also used to relieve nerve pain following||
3217|017|U|shingles (a painful rash due to herpes zoster infection) in||
3217|018|U|adults. Gabapentin is known as an anticonvulsant or antiepileptic||
3217|019|U|drug.||
3217|020|B|||
3217|021|V|OTHER USES:  This section contains uses of this drug that are not||
3217|022|V|listed in the approved professional labeling for the drug but||
3217|023|V|that may be prescribed by your health care professional. Use this||
3217|024|V|drug for a condition that is listed in this section only if it||
3217|025|V|has been so prescribed by your health care professional.||
3217|026|V|   This drug may also be used for restless legs syndrome or other||
3217|027|V|nerve pain conditions (such as diabetic neuropathy, peripheral||
3217|028|V|neuropathy, trigeminal neuralgia).||
3217|029|B|||
3217|030|H|HOW TO USE:  Read the Medication Guide and, if available, the||
3217|031|H|Patient Information Leaflet provided by your pharmacist before||
3217|032|H|you start taking gabapentin and each time you get a refill. If||
3217|033|H|you have any questions, ask your doctor or pharmacist.||
3217|034|H|   Take this medication by mouth with or without food as directed||
3217|035|H|by your doctor. The dosage is based on your medical condition and||
3217|036|H|response to treatment. Children's dosage is also based on weight.||
3217|037|H|   Carefully measure the dose using a special measuring||
3217|038|H|device/spoon. Do not use a household spoon because you may not||
3217|039|H|get the correct dose.||
3217|040|H|   It is very important to follow your doctor's dosing||
3217|041|H|instructions exactly. During the first few days of treatment,||
3217|042|H|your doctor may gradually increase your dose so your body can||
3217|043|H|adjust to the medication. To minimize side effects, take the very||
3217|044|H|first dose at bedtime.||
3217|045|H|   Take this medication regularly to get the most benefit from||
3217|046|H|it. This drug works best when the amount of medicine in your body||
3217|047|H|is kept at a constant level. Take gabapentin at evenly spaced||
3217|048|H|intervals at the same time(s) each day. If you are taking this||
3217|049|H|medication 3 times a day to control seizures, do not let more||
3217|050|H|than 12 hours pass between doses because your seizures may||
3217|051|H|increase.||
3217|052|H|   Do not take this medication more often or increase your dose||
3217|053|H|without consulting your doctor. Your condition will not improve||
3217|054|H|any faster and the risk of serious side effects may increase.||
3217|055|H|   Do not stop taking this medication without consulting your||
3217|056|H|doctor. Some conditions may become worse when this drug is||
3217|057|H|suddenly stopped. Also, you may experience symptoms such as||
3217|058|H|difficulty sleeping, sweating, nausea, and headache. To prevent||
3217|059|H|these symptoms while you are stopping treatment with this drug,||
3217|060|H|your doctor may reduce your dose gradually. Report any new or||
3217|061|H|worsening symptoms right away.||
3217|062|H|   Antacids containing aluminum or magnesium may interfere with||
3217|063|H|the absorption of this medication. If you are also taking an||
3217|064|H|antacid, it is best to take gabapentin at least 2 hours after||
3217|065|H|taking the antacid.||
3217|066|H|   Different forms of gabapentin (such as immediate-release,||
3217|067|H|sustained-release, enacarbil sustained-release) are absorbed in||
3217|068|H|the body differently. Do not switch from one form to the other||
3217|069|H|without consulting your doctor.||
3217|070|H|   Tell your doctor if your condition does not get better or if||
3217|071|H|it gets worse.||
3217|072|B|||
3217|073|S|SIDE EFFECTS:  Drowsiness, dizziness, loss of coordination,||
3217|074|S|tiredness, blurred/double vision, unusual eye movements, or||
3217|075|S|shaking (tremor) may occur. If any of these effects last or get||
3217|076|S|worse, tell your doctor or pharmacist promptly.||
3217|077|S|   Remember that this medication has been prescribed because your||
3217|078|S|doctor has judged that the benefit to you is greater than the||
3217|079|S|risk of side effects. Many people using this medication do not||
3217|080|S|have serious side effects.||
3217|081|S|   Tell your doctor right away if you have any serious side||
3217|082|S|effects, including: swelling of the hands/ankles/feet.||
3217|083|S|   A small number of people who take anticonvulsants for any||
3217|084|S|condition (such as seizures, bipolar disorder, pain) may||
3217|085|S|experience depression, suicidal thoughts/attempts, or other||
3217|086|S|mental/mood problems. These effects may occur even after the||
3217|087|S|medication has been stopped. Tell your doctor right away if you||
3217|088|S|or your family/caregiver notice any unusual/sudden changes in||
3217|089|S|your mood, thoughts, or behavior including signs of depression,||
3217|090|S|suicidal thoughts/attempts, thoughts about harming yourself.||
3217|091|S|   Get medical help right away if you have any very serious side||
3217|092|S|effects, including: slow/shallow breathing.||
3217|093|S|   A very serious allergic reaction to this drug is rare.||
3217|094|S|However, get medical help right away if you notice any symptoms||
3217|095|S|of a serious allergic reaction, including: fever, swollen lymph||
3217|096|S|nodes, rash, itching/swelling (especially of the||
3217|097|S|face/tongue/throat), severe dizziness, trouble breathing.||
3217|098|S|   This is not a complete list of possible side effects. If you||
3217|099|S|notice other effects not listed above, contact your doctor or||
3217|100|S|pharmacist.||
3217|101|S|   In the US -||
3217|102|S|   Call your doctor for medical advice about side effects. You||
3217|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3217|104|S|www.fda.gov/medwatch.||
3217|105|S|   In Canada - Call your doctor for medical advice about side||
3217|106|S|effects. You may report side effects to Health Canada at||
3217|107|S|1-866-234-2345.||
3217|108|B|||
3217|109|P|PRECAUTIONS:  Before taking gabapentin, tell your doctor or||
3217|110|P|pharmacist if you are allergic to it; or to gabapentin enacarbil;||
3217|111|P|or if you have any other allergies. This product may contain||
3217|112|P|inactive ingredients, which can cause allergic reactions or other||
3217|113|P|problems. Talk to your pharmacist for more details.||
3217|114|P|   Before using this medication, tell your doctor or pharmacist||
3217|115|P|your medical history, especially of: kidney disease, mental/mood||
3217|116|P|problems (such as depression, thoughts of suicide), use/abuse of||
3217|117|P|drugs/alcohol, breathing problems (such as COPD).||
3217|118|P|   This drug may make you dizzy or drowsy or blur your vision.||
3217|119|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3217|120|P|drowsy. Do not drive, use machinery, or do anything that needs||
3217|121|P|alertness or clear vision until you can do it safely. Limit||
3217|122|P|alcoholic beverages. Talk to your doctor if you are using||
3217|123|P|marijuana (cannabis).||
3217|124|P|   Before having surgery, tell your doctor or dentist about all||
3217|125|P|the products you use (including prescription drugs,||
3217|126|P|nonprescription drugs, and herbal products).||
3217|127|P|   Older adults may be more sensitive to the side effects of this||
3217|128|P|drug, especially swelling of the hands/ankles/feet, slow/shallow||
3217|129|P|breathing, dizziness, or loss of coordination. Dizziness and loss||
3217|130|P|of coordination can increase the risk of falling.||
3217|131|P|   Children may be more sensitive to the side effects of this||
3217|132|P|drug, especially mental/mood/behavior changes (such as hostility,||
3217|133|P|problems concentrating, restlessness).||
3217|134|P|   During pregnancy, this medication should be used only when||
3217|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
3217|136|P|   Gabapentin passes into breast milk. Consult your doctor before||
3217|137|P|breastfeeding.||
3217|138|B|||
3217|139|I|DRUG INTERACTIONS:  See also How to Use section.||
3217|140|I|   Drug interactions may change how your medications work or||
3217|141|I|increase your risk for serious side effects. This document does||
3217|142|I|not contain all possible drug interactions. Keep a list of all||
3217|143|I|the products you use (including prescription/nonprescription||
3217|144|I|drugs and herbal products) and share it with your doctor and||
3217|145|I|pharmacist. Do not start, stop, or change the dosage of any||
3217|146|I|medicines without your doctor's approval.||
3217|147|I|   A product that may interact with this drug is: orlistat.||
3217|148|I|   The risk of serious side effects (such as slow/shallow||
3217|149|I|breathing, severe drowsiness/dizziness) may be increased if this||
3217|150|I|medication is taken with other products that may also cause||
3217|151|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
3217|152|I|if you are using other products such as opioid pain or cough||
3217|153|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3217|154|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3217|155|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3217|156|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
3217|157|I|diphenhydramine).||
3217|158|I|   Check the labels on all your medicines (such as allergy or||
3217|159|I|cough-and-cold products) because they may contain ingredients||
3217|160|I|that cause drowsiness. Ask your pharmacist about using those||
3217|161|I|products safely.||
3217|162|I|   Do not use this medication with other medications that contain||
3217|163|I|gabapentin (including gabapentin enacarbil).||
3217|164|I|   This medication may interfere with certain lab tests (such as||
3217|165|I|urine protein), possibly causing false test results. Make sure||
3217|166|I|lab personnel and all your doctors know you use this drug.||
3217|167|B|||
3217|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3217|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3217|170|O|poison control center right away. US residents can call||
3217|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3217|172|O|Symptoms of overdose may include: severe drowsiness, trouble||
3217|173|O|speaking, weakness.||
3217|174|B|||
3217|175|N|NOTES:  Do not share this medication with others.||
3217|176|B|||
3217|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3217|178|D|remember. If it is near the time of the next dose, skip the||
3217|179|D|missed dose. Take your next dose at the regular time. Do not||
3217|180|D|double the dose to catch up. If you take gabapentin 3 times a day||
3217|181|D|to control seizures, do not let more than 12 hours pass between||
3217|182|D|doses because your seizures may increase. Consult your doctor||
3217|183|D|right away if this occurs.||
3217|184|B|||
3217|185|R|STORAGE:  Store in the refrigerator. Keep all medications away||
3217|186|R|from children and pets.||
3217|187|R|   Do not flush medications down the toilet or pour them into a||
3217|188|R|drain unless instructed to do so. Properly discard this product||
3217|189|R|when it is expired or no longer needed. Consult your pharmacist||
3217|190|R|or local waste disposal company.||
3217|191|B|||
3217|192|M|MEDICAL ALERT:  Your condition can cause complications in a||
3217|193|M|medical emergency. For information about enrolling in MedicAlert,||
3217|194|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3217|195|B|||
3217|196|A|Information last revised May 2025.||
3217|197|A|Copyright(c) 2025 First Databank, Inc.||
3217|198|B|||
3222|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3222|002|Z|does NOT have all possible information about this product. This||
3222|003|Z|information does not assure that this product is safe, effective,||
3222|004|Z|or appropriate for you. This information is not individual||
3222|005|Z|medical advice and does not substitute for the advice of your||
3222|006|Z|health care professional. Always ask your health care||
3222|007|Z|professional for complete information about this product and your||
3222|008|Z|specific health needs.||
3222|009|B|||
3222|010|T|IPRATROPIUM 0.06% SPRAY - NASAL||
3222|011|F|(IP-ra-TROE-pee-um)||
3222|012|B|||
3222|013|C|COMMON BRAND NAME(S): Atrovent||
3222|014|B|||
3222|015|U|USES:  Ipratropium is used to treat a runny nose caused by the||
3222|016|U|common cold or seasonal allergies. It works by reducing the||
3222|017|U|amount of fluid/mucus released from inside your nose.||
3222|018|U|   This medication does not relieve symptoms of stuffy nose or||
3222|019|U|sneezing.||
3222|020|B|||
3222|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3222|022|H|from your pharmacist before you start using ipratropium and each||
3222|023|H|time you get a refill. Learn how to use this spray properly. If||
3222|024|H|you have any questions, ask your doctor or pharmacist.||
3222|025|H|   Follow the instructions for priming the spray if you are using||
3222|026|H|it for the first time or if you have not used it for more than 24||
3222|027|H|hours. When priming the spray, make sure to spray away from the||
3222|028|H|face so that you do not get the medication into your eyes.||
3222|029|H|   Gently blow your nose before using this drug. Spray this||
3222|030|H|medication into the nose as directed by your doctor, usually 3 or||
3222|031|H|4 times a day in each nostril.||
3222|032|H|   The dosage is based on your medical condition, age, and||
3222|033|H|response to treatment.||
3222|034|H|   Avoid getting this medication into your eyes. It may cause eye||
3222|035|H|pain/irritation, temporary blurred vision, and other vision||
3222|036|H|changes. If this medication does get into your eyes, flush your||
3222|037|H|eyes with water for a few minutes. Tell your doctor right away if||
3222|038|H|any symptoms occur.||
3222|039|H|   Use this medication regularly in order to get the most benefit||
3222|040|H|from it. This medication works best if used at evenly spaced||
3222|041|H|intervals. To help you remember, use it at the same times each||
3222|042|H|day. Do not increase your dose or use this medication more often||
3222|043|H|or for a longer time than directed without first consulting your||
3222|044|H|doctor.||
3222|045|H|   If the spray gets clogged, hold the nasal tip under warm||
3222|046|H|running water for about a minute. Dry the nasal tip and prime the||
3222|047|H|spray again. Do not use a sharp object to clear the spray.||
3222|048|H|   You may start to feel better on the first day after using this||
3222|049|H|medication. Tell your doctor if your condition does not get||
3222|050|H|better or if it gets worse.||
3222|051|B|||
3222|052|S|SIDE EFFECTS:  See also How to Use section.||
3222|053|S|   Dry/bloody nose, headache, dry mouth/throat, throat||
3222|054|S|irritation, bad taste in mouth, dizziness, or constipation may||
3222|055|S|occur. If any of these effects last or get worse, tell your||
3222|056|S|doctor or pharmacist promptly.||
3222|057|S|   Remember that this medication has been prescribed because your||
3222|058|S|doctor has judged that the benefit to you is greater than the||
3222|059|S|risk of side effects. Many people using this medication do not||
3222|060|S|have serious side effects.||
3222|061|S|   Tell your doctor right away if you have any serious side||
3222|062|S|effects, including: difficult/painful urination, fast/pounding||
3222|063|S|heartbeat.||
3222|064|S|   Get medical help right away if you have any very serious side||
3222|065|S|effects, including: eye pain/swelling/redness, vision changes||
3222|066|S|(such as seeing rainbows around lights at night, blurred vision).||
3222|067|S|   A very serious allergic reaction to this product is rare.||
3222|068|S|However, get medical help right away if you notice any symptoms||
3222|069|S|of a serious allergic reaction, including: rash, itching/swelling||
3222|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3222|071|S|breathing.||
3222|072|S|   This is not a complete list of possible side effects. If you||
3222|073|S|notice other effects not listed above, contact your doctor or||
3222|074|S|pharmacist.||
3222|075|S|   In the US -||
3222|076|S|   Call your doctor for medical advice about side effects. You||
3222|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3222|078|S|www.fda.gov/medwatch.||
3222|079|S|   In Canada - Call your doctor for medical advice about side||
3222|080|S|effects. You may report side effects to Health Canada at||
3222|081|S|1-866-234-2345.||
3222|082|B|||
3222|083|P|PRECAUTIONS:  Before using ipratropium, tell your doctor or||
3222|084|P|pharmacist if you are allergic to it or to tiotropium; or to||
3222|085|P|atropine or other belladonna-type drugs; or if you have any other||
3222|086|P|allergies. This product may contain inactive ingredients, which||
3222|087|P|can cause allergic reactions or other problems. Talk to your||
3222|088|P|pharmacist for more details.||
3222|089|P|   Before using this medication, tell your doctor or pharmacist||
3222|090|P|your medical history, especially of: personal or family history||
3222|091|P|of glaucoma (angle-closure type), difficulty urinating (for||
3222|092|P|example, due to enlarged prostate).||
3222|093|P|   Although unlikely, this drug may make you dizzy or blur your||
3222|094|P|vision or cause other vision changes. Alcohol or marijuana||
3222|095|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
3222|096|P|or do anything that needs alertness or clear vision until you can||
3222|097|P|do it safely. Limit alcoholic beverages. Talk to your doctor if||
3222|098|P|you are using marijuana (cannabis).||
3222|099|P|   Before having surgery, tell your doctor or dentist about all||
3222|100|P|the products you use (including prescription drugs,||
3222|101|P|nonprescription drugs, and herbal products).||
3222|102|P|   Older adults may be more sensitive to the side effects of this||
3222|103|P|drug, especially problems urinating or constipation.||
3222|104|P|   During pregnancy, this medication should be used only when||
3222|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
3222|106|P|   It is unknown if this medication passes into breast milk.||
3222|107|P|Consult your doctor before breastfeeding.||
3222|108|B|||
3222|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3222|110|I|medications work or increase your risk for serious side effects.||
3222|111|I|This document does not contain all possible drug interactions.||
3222|112|I|Keep a list of all the products you use (including||
3222|113|I|prescription/nonprescription drugs and herbal products) and share||
3222|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
3222|115|I|the dosage of any medicines without your doctor's approval.||
3222|116|B|||
3222|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3222|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3222|119|O|poison control center right away. US residents can call||
3222|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3222|121|B|||
3222|122|N|NOTES:  Do not share this medication with others.||
3222|123|B|||
3222|124|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3222|125|D|If it is near the time of the next dose, skip the missed dose.||
3222|126|D|Use your next dose at the regular time. Do not double the dose to||
3222|127|D|catch up.||
3222|128|B|||
3222|129|R|STORAGE:  Store at room temperature with the cap on. Do not||
3222|130|R|refrigerate or freeze. Keep all medications away from children||
3222|131|R|and pets.||
3222|132|R|   Do not flush medications down the toilet or pour them into a||
3222|133|R|drain unless instructed to do so. Properly discard this product||
3222|134|R|when it is expired or no longer needed. Consult your pharmacist||
3222|135|R|or local waste disposal company.||
3222|136|B|||
3222|137|A|Information last revised November 2024.||
3222|138|A|Copyright(c) 2025 First Databank, Inc.||
3222|139|B|||
3223|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3223|002|Z|does NOT have all possible information about this product. This||
3223|003|Z|information does not assure that this product is safe, effective,||
3223|004|Z|or appropriate for you. This information is not individual||
3223|005|Z|medical advice and does not substitute for the advice of your||
3223|006|Z|health care professional. Always ask your health care||
3223|007|Z|professional for complete information about this product and your||
3223|008|Z|specific health needs.||
3223|009|B|||
3223|010|T|AZITHROMYCIN 250/500 MG - ORAL||
3223|011|F|(ay-ZITH-roe-MYE-sin)||
3223|012|B|||
3223|013|C|COMMON BRAND NAME(S): Zithromax||
3223|014|B|||
3223|015|U|USES:  Azithromycin is used to treat a wide variety of bacterial||
3223|016|U|infections. It is a macrolide-type antibiotic. It works by||
3223|017|U|stopping the growth of bacteria.||
3223|018|U|   This medication will not work for viral infections (such as||
3223|019|U|common cold, flu). Unnecessary use or misuse of any antibiotic||
3223|020|U|can lead to its decreased effectiveness.||
3223|021|B|||
3223|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3223|023|H|from your pharmacist before you start taking azithromycin and||
3223|024|H|each time you get a refill. If you have any questions, ask your||
3223|025|H|doctor or pharmacist.||
3223|026|H|   Take this medication by mouth as directed by your doctor,||
3223|027|H|usually once daily with or without food. You may take this||
3223|028|H|medication with food if stomach upset occurs. The dosage is based||
3223|029|H|on your medical condition and response to treatment.||
3223|030|H|   For the best effect, take this antibiotic at evenly spaced||
3223|031|H|times. To help you remember, take this medication at the same||
3223|032|H|time(s) every day.||
3223|033|H|   Continue to take this medication until the full prescribed||
3223|034|H|amount is finished, even if symptoms disappear after a few days.||
3223|035|H|Stopping the medication too early may result in a return of the||
3223|036|H|infection.||
3223|037|H|   Tell your doctor if your condition lasts or gets worse.||
3223|038|B|||
3223|039|S|SIDE EFFECTS:  Stomach upset, diarrhea/loose stools, nausea,||
3223|040|S|vomiting, or abdominal pain may occur. If any of these effects||
3223|041|S|last or get worse, tell your doctor or pharmacist promptly.||
3223|042|S|   Remember that this medication has been prescribed because your||
3223|043|S|doctor has judged that the benefit to you is greater than the||
3223|044|S|risk of side effects. Many people using this medication do not||
3223|045|S|have serious side effects.||
3223|046|S|   Tell your doctor right away if you have any serious side||
3223|047|S|effects, including: hearing changes (such as decreased hearing,||
3223|048|S|deafness), eye problems (such as drooping eyelids, blurred||
3223|049|S|vision), difficulty speaking/swallowing, muscle weakness, signs||
3223|050|S|of liver problems (such as nausea/vomiting that doesn't stop,||
3223|051|S|unusual tiredness, severe stomach/abdominal pain, yellowing||
3223|052|S|eyes/skin, dark urine).||
3223|053|S|   Get medical help right away if you have any very serious side||
3223|054|S|effects, including: fast/irregular heartbeat, severe dizziness,||
3223|055|S|fainting.||
3223|056|S|   This medication may rarely cause a severe intestinal condition||
3223|057|S|due to a bacteria called C. difficile. This condition may occur||
3223|058|S|during treatment or weeks to months after treatment has stopped.||
3223|059|S|Tell your doctor right away if you develop: diarrhea that doesn't||
3223|060|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
3223|061|S|stool.||
3223|062|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
3223|063|S|products because they may make symptoms worse.||
3223|064|S|   Use of this medication for prolonged or repeated periods may||
3223|065|S|result in oral thrush or a new yeast infection. Contact your||
3223|066|S|doctor if you notice white patches in your mouth, a change in||
3223|067|S|vaginal discharge, or other new symptoms.||
3223|068|S|   A very serious allergic reaction to this drug is rare.||
3223|069|S|However, get medical help right away if you notice any symptoms||
3223|070|S|of a serious allergic reaction, including: fever that doesn't go||
3223|071|S|away, new or worsening lymph node swelling, rash,||
3223|072|S|itching/swelling (especially of the face/tongue/throat), severe||
3223|073|S|dizziness, trouble breathing.||
3223|074|S|   An allergic reaction to this medication may return even if you||
3223|075|S|stop the drug. If you have an allergic reaction, continue to||
3223|076|S|watch for any of the above symptoms for several days after your||
3223|077|S|last dose.||
3223|078|S|   This is not a complete list of possible side effects. If you||
3223|079|S|notice other effects not listed above, contact your doctor or||
3223|080|S|pharmacist.||
3223|081|S|   In the US -||
3223|082|S|   Call your doctor for medical advice about side effects. You||
3223|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3223|084|S|www.fda.gov/medwatch.||
3223|085|S|   In Canada - Call your doctor for medical advice about side||
3223|086|S|effects. You may report side effects to Health Canada at||
3223|087|S|1-866-234-2345.||
3223|088|B|||
3223|089|P|PRECAUTIONS:  Before taking azithromycin, tell your doctor or||
3223|090|P|pharmacist if you are allergic to it; or to other antibiotics||
3223|091|P|(such as erythromycin, clarithromycin, telithromycin); or if you||
3223|092|P|have any other allergies. This product may contain inactive||
3223|093|P|ingredients, which can cause allergic reactions or other||
3223|094|P|problems. Talk to your pharmacist for more details.||
3223|095|P|   Before using this medication, tell your doctor or pharmacist||
3223|096|P|your medical history, especially of: liver disease, kidney||
3223|097|P|disease, a certain muscle disease (myasthenia gravis).||
3223|098|P|   Azithromycin may cause a condition that affects the heart||
3223|099|P|rhythm (QT prolongation). QT prolongation can rarely cause||
3223|100|P|serious (rarely fatal) fast/irregular heartbeat and other||
3223|101|P|symptoms (such as severe dizziness, fainting) that need medical||
3223|102|P|attention right away.||
3223|103|P|   The risk of QT prolongation may be increased if you have||
3223|104|P|certain medical conditions or are taking other drugs that may||
3223|105|P|cause QT prolongation. Before using azithromycin, tell your||
3223|106|P|doctor or pharmacist of all the drugs you take and if you have||
3223|107|P|any of the following conditions: certain heart problems (heart||
3223|108|P|failure, slow heartbeat, QT prolongation in the EKG), family||
3223|109|P|history of certain heart problems (QT prolongation in the EKG,||
3223|110|P|sudden cardiac death).||
3223|111|P|   Low levels of potassium or magnesium in the blood may also||
3223|112|P|increase your risk of QT prolongation. This risk may increase if||
3223|113|P|you use certain drugs (such as diuretics/"water pills") or if you||
3223|114|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3223|115|P|Talk to your doctor about using azithromycin safely.||
3223|116|P|   Azithromycin may cause live bacterial vaccines (such as||
3223|117|P|typhoid vaccine) to not work well. Tell your health care||
3223|118|P|professional that you are using azithromycin before having any||
3223|119|P|immunizations/vaccinations.||
3223|120|P|   Before having surgery, tell your doctor or dentist about all||
3223|121|P|the products you use (including prescription drugs,||
3223|122|P|nonprescription drugs, and herbal products).||
3223|123|P|   Older adults may be more sensitive to the side effects of this||
3223|124|P|drug, especially QT prolongation (see above).||
3223|125|P|   During pregnancy, this medication should be used only when||
3223|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
3223|127|P|   This drug passes into breast milk. Consult your doctor before||
3223|128|P|breastfeeding.||
3223|129|B|||
3223|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3223|131|I|medications work or increase your risk for serious side effects.||
3223|132|I|This document does not contain all possible drug interactions.||
3223|133|I|Keep a list of all the products you use (including||
3223|134|I|prescription/nonprescription drugs and herbal products) and share||
3223|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
3223|136|I|the dosage of any medicines without your doctor's approval.||
3223|137|I|   This medication can slow down the removal of other medications||
3223|138|I|from your body, which may affect how they work. Examples of||
3223|139|I|affected drugs include colchicine, among others.||
3223|140|I|   Many drugs besides azithromycin may affect the heart rhythm||
3223|141|I|(QT prolongation), including amiodarone, chloroquine,||
3223|142|I|disopyramide, dofetilide, dronedarone, hydroxychloroquine,||
3223|143|I|ibutilide, pimozide, procainamide, quinidine, sotalol, among||
3223|144|I|others.||
3223|145|B|||
3223|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3223|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3223|148|O|poison control center right away. US residents can call||
3223|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3223|150|B|||
3223|151|N|NOTES:  Do not share this medication with others.||
3223|152|N|   This medication has been prescribed for your current condition||
3223|153|N|only. Do not use it later for another infection unless your||
3223|154|N|doctor tells you to.||
3223|155|B|||
3223|156|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3223|157|D|remember. If it is near the time of the next dose, skip the||
3223|158|D|missed dose. Take your next dose at the regular time. Do not||
3223|159|D|double the dose to catch up.||
3223|160|B|||
3223|161|R|STORAGE:  Store at room temperature away from light and moisture.||
3223|162|R|Do not store in the bathroom. Keep all medications away from||
3223|163|R|children and pets.||
3223|164|R|   Do not flush medications down the toilet or pour them into a||
3223|165|R|drain unless instructed to do so. Properly discard this product||
3223|166|R|when it is expired or no longer needed. Consult your pharmacist||
3223|167|R|or local waste disposal company.||
3223|168|B|||
3223|169|A|Information last revised December 2024.||
3223|170|A|Copyright(c) 2025 First Databank, Inc.||
3223|171|B|||
3224|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3224|002|Z|does NOT have all possible information about this product. This||
3224|003|Z|information does not assure that this product is safe, effective,||
3224|004|Z|or appropriate for you. This information is not individual||
3224|005|Z|medical advice and does not substitute for the advice of your||
3224|006|Z|health care professional. Always ask your health care||
3224|007|Z|professional for complete information about this product and your||
3224|008|Z|specific health needs.||
3224|009|B|||
3224|010|T|FLUPHENAZINE - ORAL||
3224|011|F|(flew-FEN-uh-zeen)||
3224|012|B|||
3224|013|C|COMMON BRAND NAME(S): Prolixin||
3224|014|B|||
3224|015|W|WARNING:  There may be a slightly increased risk of serious,||
3224|016|W|possibly fatal side effects (such as heart failure,||
3224|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
3224|018|W|by older adults with dementia. This medication is not approved||
3224|019|W|for the treatment of dementia-related behavior problems. Discuss||
3224|020|W|the risks and benefits of this medication, as well as other||
3224|021|W|effective and possibly safer treatments for dementia-related||
3224|022|W|behavior problems, with the doctor.||
3224|023|B|||
3224|024|U|USES:  This medication is used to treat certain mental/mood||
3224|025|U|disorders (such as schizophrenia). Fluphenazine belongs to a||
3224|026|U|class of drugs known as antipsychotics. It works by helping to||
3224|027|U|restore the balance of certain natural substances in the brain.||
3224|028|U|   This medication is not recommended for use in children under||
3224|029|U|12 years of age.||
3224|030|B|||
3224|031|H|HOW TO USE:  Take this medication by mouth with or without food||
3224|032|H|as directed by your doctor, usually 1 to 4 times daily. The||
3224|033|H|dosage is based on your age, medical condition, and response to||
3224|034|H|treatment.||
3224|035|H|   Use this medication regularly to get the most benefit from it.||
3224|036|H|To help you remember, take it at the same time(s) each day.||
3224|037|H|   Do not stop taking this medication without consulting your||
3224|038|H|doctor. Some conditions may become worse when this drug is||
3224|039|H|suddenly stopped. Your dose may need to be gradually decreased.||
3224|040|H|   It may take up to two weeks for the full benefit of this||
3224|041|H|medication to take effect. Tell your doctor if your condition||
3224|042|H|does not get better or if it gets worse.||
3224|043|B|||
3224|044|S|SIDE EFFECTS:  Drowsiness, lethargy, dizziness, lightheadedness,||
3224|045|S|nausea, loss of appetite, sweating, dry mouth, blurred vision,||
3224|046|S|headache, and constipation may occur. If any of these effects||
3224|047|S|last or get worse, notify your doctor or pharmacist promptly.||
3224|048|S|   Dizziness and lightheadedness can increase the risk of||
3224|049|S|falling. Get up slowly when rising from a sitting or lying||
3224|050|S|position.||
3224|051|S|   Tell your doctor right away if any of these side effects||
3224|052|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
3224|053|S|mask-like expression of the face, drooling/trouble swallowing, or||
3224|054|S|shuffling walk. Your doctor may prescribe another medication to||
3224|055|S|decrease these side effects.||
3224|056|S|   Remember that this medication has been prescribed because your||
3224|057|S|doctor has judged that the benefit to you is greater than the||
3224|058|S|risk of side effects. Many people using this medication do not||
3224|059|S|have serious side effects.||
3224|060|S|   Tell your doctor right away if you have any serious side||
3224|061|S|effects, including: unusual mental/mood changes (such as||
3224|062|S|depression, confusion, worsening of psychosis), unusual dreams,||
3224|063|S|frequent urination or difficulty urinating, vision problems,||
3224|064|S|weight change, swelling of the feet/ankles, fainting, skin||
3224|065|S|discoloration, butterfly-shaped facial rash, joint pain,||
3224|066|S|seizures.||
3224|067|S|   In rare instances, this medication may increase your level of||
3224|068|S|a certain hormone (prolactin). For females, this rare increase in||
3224|069|S|prolactin may result in unwanted breast milk, missing/stopped||
3224|070|S|menstrual periods, or difficulty becoming pregnant. For males, it||
3224|071|S|may result in decreased sexual ability, inability to produce||
3224|072|S|sperm, or enlarged breasts. If you develop any of these symptoms,||
3224|073|S|tell your doctor right away.||
3224|074|S|   Rarely, males may have a painful or prolonged erection lasting||
3224|075|S|4 or more hours. If this occurs, stop using this drug and get||
3224|076|S|medical help right away, or permanent problems could occur.||
3224|077|S|   Fluphenazine may rarely cause a condition known as tardive||
3224|078|S|dyskinesia. In some cases, this condition may be permanent. Tell||
3224|079|S|your doctor right away if you develop any unusual/uncontrolled||
3224|080|S|movements (especially of the face, mouth, tongue, arms, or legs).||
3224|081|S|   This medication may rarely cause a very serious condition||
3224|082|S|called neuroleptic malignant syndrome (NMS). Get medical help||
3224|083|S|right away if you have any of the following symptoms: fever,||
3224|084|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
3224|085|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
3224|086|S|signs of kidney problems (such as change in the amount of urine).||
3224|087|S|   This drug may rarely cause serious blood problems (such as||
3224|088|S|agranulocytosis, leukopenia) or liver problems. Get medical help||
3224|089|S|right away if you notice any of the following rare but very||
3224|090|S|serious side effects: signs of infection (such as sore throat||
3224|091|S|that doesn't go away, fever, chills), easy bruising/bleeding,||
3224|092|S|severe stomach/abdominal pain, yellowing of the eyes/skin.||
3224|093|S|   A very serious allergic reaction to this drug is rare.||
3224|094|S|However, get medical help right away if you notice any symptoms||
3224|095|S|of a serious allergic reaction, including: rash, itching/swelling||
3224|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3224|097|S|breathing.||
3224|098|S|   This is not a complete list of possible side effects. If you||
3224|099|S|notice other effects not listed above, contact your doctor or||
3224|100|S|pharmacist.||
3224|101|S|   In the US -||
3224|102|S|   Call your doctor for medical advice about side effects. You||
3224|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3224|104|S|www.fda.gov/medwatch.||
3224|105|S|   In Canada - Call your doctor for medical advice about side||
3224|106|S|effects. You may report side effects to Health Canada at||
3224|107|S|1-866-234-2345.||
3224|108|B|||
3224|109|P|PRECAUTIONS:  Before taking fluphenazine, tell your doctor or||
3224|110|P|pharmacist if you are allergic to it; or to other phenothiazines||
3224|111|P|(such as chlorpromazine, perphenazine); or if you have any other||
3224|112|P|allergies. This product may contain inactive ingredients, which||
3224|113|P|can cause allergic reactions or other problems. Talk to your||
3224|114|P|pharmacist for more details.||
3224|115|P|   Before using this medication, tell your doctor or pharmacist||
3224|116|P|your medical history, especially of: brain damage, nervous system||
3224|117|P|problems (such as CNS depression, cerebrovascular insufficiency,||
3224|118|P|brain tumors, encephalitis, encephalopathy), blood problems (such||
3224|119|P|as leukopenia, thrombocytopenia, agranulocytosis), liver||
3224|120|P|problems, breast cancer, eye problems (such as glaucoma), heart||
3224|121|P|problems (such as very high or very low blood pressure, mitral||
3224|122|P|valve insufficiency), kidney problems, a certain adrenal gland||
3224|123|P|tumor (pheochromocytoma), seizures, exposure to phosphorus||
3224|124|P|insecticides, chronic breathing problems (such as asthma,||
3224|125|P|emphysema, frequent infections), low blood calcium, enlarged||
3224|126|P|prostate, drug or alcohol dependency, Reye's syndrome,||
3224|127|P|dehydration.||
3224|128|P|   Before having surgery or any diagnostic testing, tell your||
3224|129|P|doctor or dentist about all the products you use (including||
3224|130|P|prescription drugs, nonprescription drugs, and herbal products).||
3224|131|P|   This drug may make you dizzy or drowsy or blur your vision.||
3224|132|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3224|133|P|drowsy. Do not drive, use machinery, or do anything that needs||
3224|134|P|alertness or clear vision until you can do it safely. Avoid||
3224|135|P|alcoholic beverages. Talk to your doctor if you are using||
3224|136|P|marijuana (cannabis).||
3224|137|P|   This medication may make you more sensitive to the sun. Limit||
3224|138|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
3224|139|P|sunscreen and wear protective clothing when outdoors. Tell your||
3224|140|P|doctor right away if you get sunburned or have skin||
3224|141|P|blisters/redness.||
3224|142|P|   This medication may make you sweat less, making you more||
3224|143|P|likely to get heat stroke. Avoid doing things that may cause you||
3224|144|P|to overheat, such as hard work or exercise in hot weather, or||
3224|145|P|using hot tubs. When the weather is hot, drink a lot of fluids||
3224|146|P|and dress lightly. If you overheat, quickly look for a place to||
3224|147|P|cool down and rest. Get medical help right away if you have a||
3224|148|P|fever that does not go away, mental/mood changes, headache, or||
3224|149|P|dizziness.||
3224|150|P|   Avoid being exposed to very cold temperatures (such as||
3224|151|P|swimming in cold water). Severe lowering of your body temperature||
3224|152|P|may occur.||
3224|153|P|   Children may be more sensitive to the side effects of this||
3224|154|P|drug, especially the side effect of uncontrolled movements. This||
3224|155|P|is especially true if the child is sick (such as has chickenpox,||
3224|156|P|measles, stomach flu).||
3224|157|P|   Older adults may be more sensitive to the side effects of this||
3224|158|P|drug, especially to facial or muscle twitching, muscle||
3224|159|P|spasms/stiffness, uncontrolled movements (tardive dyskinesia),||
3224|160|P|drowsiness, dizziness, lightheadedness, confusion, and possible||
3224|161|P|effects on blood pressure. Drowsiness, dizziness,||
3224|162|P|lightheadedness, and confusion can increase the risk of falling.||
3224|163|P|   During pregnancy, this medication should be used only when||
3224|164|P|clearly needed. Liver problems or birth defects may occur in||
3224|165|P|infants exposed to this type of medication in the womb. Tell the||
3224|166|P|doctor right away if you notice yellowing of the eyes/skin or||
3224|167|P|dark urine in your infant. Babies born to mothers who have used||
3224|168|P|this drug during the last 3 months of pregnancy may rarely||
3224|169|P|develop symptoms including muscle stiffness or shakiness,||
3224|170|P|drowsiness, feeding/breathing difficulties, or constant crying.||
3224|171|P|If you notice any of these symptoms in your newborn especially||
3224|172|P|during their first month, tell the doctor right away.||
3224|173|P|   Since untreated mental/mood problems (such as schizophrenia)||
3224|174|P|can be a serious condition, do not stop taking this medication||
3224|175|P|unless directed by your doctor. If you are planning pregnancy,||
3224|176|P|become pregnant, or think you may be pregnant, immediately||
3224|177|P|discuss with your doctor the benefits and risks of using this||
3224|178|P|medication during pregnancy.||
3224|179|P|   It is unknown if this medication passes into breast milk.||
3224|180|P|However, similar drugs pass into breast milk. Consult your doctor||
3224|181|P|before breastfeeding.||
3224|182|B|||
3224|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3224|184|I|medications work or increase your risk for serious side effects.||
3224|185|I|This document does not contain all possible drug interactions.||
3224|186|I|Keep a list of all the products you use (including||
3224|187|I|prescription/nonprescription drugs and herbal products) and share||
3224|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
3224|189|I|the dosage of any medicines without your doctor's approval.||
3224|190|I|   Some products that may interact with this drug are: guanadrel,||
3224|191|I|guanethidine, lithium.||
3224|192|I|   Tell your doctor or pharmacist if you are taking other||
3224|193|I|products that cause drowsiness such as opioid pain or cough||
3224|194|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3224|195|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3224|196|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3224|197|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
3224|198|I|diphenhydramine).||
3224|199|I|   Check the labels on all your medicines (such as allergy or||
3224|200|I|cough-and-cold products) because they may contain ingredients||
3224|201|I|that cause drowsiness. Ask your pharmacist about using those||
3224|202|I|products safely.||
3224|203|I|   This medication may interfere with certain lab tests (such as||
3224|204|I|pregnancy test, phenylketonuria test, some urine tests), possibly||
3224|205|I|causing false test results. Make sure lab personnel and all your||
3224|206|I|doctors know you use this drug.||
3224|207|B|||
3224|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3224|209|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3224|210|O|poison control center right away. US residents can call||
3224|211|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3224|212|O|Symptoms of overdose may include: loss of consciousness,||
3224|213|O|seizures, fast/irregular heartbeat, or slow/shallow breathing.||
3224|214|B|||
3224|215|N|NOTES:  Do not share this medication with others.||
3224|216|N|   Lab and/or medical tests (such as liver/kidney function,||
3224|217|N|complete blood counts, eye exams, AIMS test) should be done while||
3224|218|N|you are taking this medication. Keep all medical and lab||
3224|219|N|appointments. Consult your doctor for more details.||
3224|220|B|||
3224|221|D|MISSED DOSE:  If you are taking this medication once daily and||
3224|222|D|you miss a dose, take it as soon as you remember. If it is near||
3224|223|D|the time of the next dose, skip the missed dose. Take your next||
3224|224|D|dose at the regular time. Do not double the dose to catch up.||
3224|225|D|   If you are taking this medication more than once daily and you||
3224|226|D|miss a dose, take it as soon as you remember. If it is more than||
3224|227|D|1 hour after the missed dose, skip the missed dose. Take your||
3224|228|D|next dose at the regular time. Do not double the dose to catch||
3224|229|D|up.||
3224|230|B|||
3224|231|R|STORAGE:  Store at room temperature away from light and moisture.||
3224|232|R|Do not store in the bathroom. Keep all medications away from||
3224|233|R|children and pets.||
3224|234|R|   Do not flush medications down the toilet or pour them into a||
3224|235|R|drain unless instructed to do so. Properly discard this product||
3224|236|R|when it is expired or no longer needed. Consult your pharmacist||
3224|237|R|or local waste disposal company.||
3224|238|B|||
3224|239|A|Information last revised May 2025.||
3224|240|A|Copyright(c) 2025 First Databank, Inc.||
3224|241|B|||
3225|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3225|002|Z|does NOT have all possible information about this product. This||
3225|003|Z|information does not assure that this product is safe, effective,||
3225|004|Z|or appropriate for you. This information is not individual||
3225|005|Z|medical advice and does not substitute for the advice of your||
3225|006|Z|health care professional. Always ask your health care||
3225|007|Z|professional for complete information about this product and your||
3225|008|Z|specific health needs.||
3225|009|B|||
3225|010|T|DILTIAZEM 12-HOUR SUSTAINED-ACTION CAPSULE - ORAL||
3225|011|F|(dill-TIE-uh-zem)||
3225|012|B|||
3225|013|C|COMMON BRAND NAME(S): Cardizem SR||
3225|014|B|||
3225|015|U|USES:  Diltiazem 12-hour sustained-action capsules are used to||
3225|016|U|treat high blood pressure (hypertension). Lowering high blood||
3225|017|U|pressure helps prevent strokes, heart attacks, and kidney||
3225|018|U|problems. Diltiazem is called a calcium channel blocker. It works||
3225|019|U|by relaxing blood vessels in the body and heart so blood can flow||
3225|020|U|more easily. This effect lowers blood pressure. Diltiazem may||
3225|021|U|also lower your heart rate.||
3225|022|B|||
3225|023|V|OTHER USES:  This section contains uses of this drug that are not||
3225|024|V|listed in the approved professional labeling for the drug but||
3225|025|V|that may be prescribed by your health care professional. Use this||
3225|026|V|drug for a condition that is listed in this section only if it||
3225|027|V|has been so prescribed by your health care professional.||
3225|028|V|   This drug may also be used to reduce the risk of chest pain||
3225|029|V|(angina). When used regularly, diltiazem can decrease the number||
3225|030|V|and severity of episodes of chest pain from angina. It may also||
3225|031|V|be used to control your heart rate if you have a fast/irregular||
3225|032|V|heartbeat (such as atrial fibrillation).||
3225|033|B|||
3225|034|H|HOW TO USE:  Take this medication by mouth with or without food||
3225|035|H|as directed by your doctor, usually twice daily. Swallow the||
3225|036|H|capsules whole. Do not crush or chew the capsules. Doing so can||
3225|037|H|release all of the drug at once and may increase your risk of||
3225|038|H|side effects.||
3225|039|H|   Your doctor may gradually increase your dose. Follow your||
3225|040|H|doctor's instructions carefully. The dosage is based on your||
3225|041|H|medical condition, response to treatment, and other medications||
3225|042|H|you may be taking. Be sure to tell your doctor and pharmacist||
3225|043|H|about all the products you use (including prescription drugs,||
3225|044|H|nonprescription drugs, and herbal products).||
3225|045|H|   Use this medication regularly to get the most benefit from it.||
3225|046|H|To help you remember, use it at the same times each day. Keep||
3225|047|H|taking this medication even if you feel well. Most people with||
3225|048|H|high blood pressure do not feel sick.||
3225|049|H|   If this medication is used for angina, this medication must be||
3225|050|H|taken regularly to be effective. It should not be used to treat||
3225|051|H|angina when it occurs. Use other medications (such as||
3225|052|H|nitroglycerin placed under the tongue) to relieve an angina||
3225|053|H|attack as directed by your doctor. Consult your doctor or||
3225|054|H|pharmacist for details.||
3225|055|H|   It may take up to 2 weeks before you get the full benefit of||
3225|056|H|this drug. Tell your doctor if your condition does not get better||
3225|057|H|or if it gets worse (your blood pressure readings remain high or||
3225|058|H|increase).||
3225|059|B|||
3225|060|S|SIDE EFFECTS:  Dizziness, lightheadedness, weakness, nausea,||
3225|061|S|flushing, constipation and headache may occur. If any of these||
3225|062|S|effects last or get worse, tell your doctor or pharmacist||
3225|063|S|promptly.||
3225|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
3225|065|S|slowly when rising from a sitting or lying position.||
3225|066|S|   Remember that this medication has been prescribed because your||
3225|067|S|doctor has judged that the benefit to you is greater than the||
3225|068|S|risk of side effects. Many people using this medication do not||
3225|069|S|have serious side effects.||
3225|070|S|   Tell your doctor right away if you have any serious side||
3225|071|S|effects, including: nausea/vomiting that doesn't stop, fainting,||
3225|072|S|new or worsening symptoms of heart failure (such as shortness of||
3225|073|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
3225|074|S|weight gain), slow/irregular/pounding/fast heartbeat, mental/mood||
3225|075|S|changes (such as depression, agitation), unusual dreams, severe||
3225|076|S|stomach/abdominal pain, dark urine, yellowing eyes/skin.||
3225|077|S|   A very serious allergic reaction to this drug is rare.||
3225|078|S|However, get medical help right away if you notice any symptoms||
3225|079|S|of a serious allergic reaction, including: rash, itching/swelling||
3225|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3225|081|S|breathing.||
3225|082|S|   This is not a complete list of possible side effects. If you||
3225|083|S|notice other effects not listed above, contact your doctor or||
3225|084|S|pharmacist.||
3225|085|S|   In the US -||
3225|086|S|   Call your doctor for medical advice about side effects. You||
3225|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3225|088|S|www.fda.gov/medwatch.||
3225|089|S|   In Canada - Call your doctor for medical advice about side||
3225|090|S|effects. You may report side effects to Health Canada at||
3225|091|S|1-866-234-2345.||
3225|092|B|||
3225|093|P|PRECAUTIONS:  Before taking diltiazem, tell your doctor or||
3225|094|P|pharmacist if you are allergic to it; or if you have any other||
3225|095|P|allergies. This product may contain inactive ingredients, which||
3225|096|P|can cause allergic reactions or other problems. Talk to your||
3225|097|P|pharmacist for more details.||
3225|098|P|   Before using this medication, tell your doctor or pharmacist||
3225|099|P|your medical history, especially of: certain types of heart||
3225|100|P|rhythm problems (such as sick sinus syndrome/atrioventricular||
3225|101|P|block), liver disease, kidney disease, heart failure.||
3225|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3225|103|P|can make you more dizzy. Do not drive, use machinery, or do||
3225|104|P|anything that needs alertness until you can do it safely. Limit||
3225|105|P|alcoholic beverages. Talk to your doctor if you are using||
3225|106|P|marijuana (cannabis).||
3225|107|P|   Before having surgery, tell your doctor or dentist about all||
3225|108|P|the products you use (including prescription drugs,||
3225|109|P|nonprescription drugs, and herbal products).||
3225|110|P|   Older adults may be more sensitive to the side effects of this||
3225|111|P|drug, especially dizziness, constipation, or swelling||
3225|112|P|ankles/feet.||
3225|113|P|   During pregnancy, this medication should be used only when||
3225|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
3225|115|P|   This drug passes into breast milk and may have undesirable||
3225|116|P|effects on a nursing infant. Consult your doctor before||
3225|117|P|breastfeeding.||
3225|118|B|||
3225|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3225|120|I|medications work or increase your risk for serious side effects.||
3225|121|I|This document does not contain all possible drug interactions.||
3225|122|I|Keep a list of all the products you use (including||
3225|123|I|prescription/nonprescription drugs and herbal products) and share||
3225|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
3225|125|I|the dosage of any medicines without your doctor's approval.||
3225|126|I|   Some products that may interact with this drug include:||
3225|127|I|digoxin, fingolimod, labetalol.||
3225|128|I|   Other medications can affect the removal of diltiazem from||
3225|129|I|your body, which may affect how this medication works. Examples||
3225|130|I|include azole antifungals (such as ketoconazole), cimetidine,||
3225|131|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
3225|132|I|rifabutin, rifampin), St. John's wort, among others.||
3225|133|I|   This medication can slow down the removal of other medications||
3225|134|I|from your body, which may affect how they work. Examples of||
3225|135|I|affected drugs include aprepitant/fosaprepitant, buspirone,||
3225|136|I|colchicine, elacestrant, flibanserin, ivabradine, lomitapide,||
3225|137|I|certain benzodiazepines (triazolam, midazolam), among others.||
3225|138|I|   Some products have ingredients that could raise your heart||
3225|139|I|rate or blood pressure. Tell your pharmacist what products you||
3225|140|I|are using, and ask how to use them safely (especially||
3225|141|I|cough-and-cold products, diet aids, or NSAIDs such as||
3225|142|I|ibuprofen/naproxen).||
3225|143|B|||
3225|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3225|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3225|146|O|poison control center right away. US residents can call||
3225|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3225|148|B|||
3225|149|N|NOTES:  Do not share this medication with others. Talk with your||
3225|150|N|doctor about making changes to your lifestyle that may help this||
3225|151|N|medication work better (such as stress reduction programs,||
3225|152|N|exercise, and dietary changes).||
3225|153|N|   Lab and/or medical tests (such as kidney/liver function,||
3225|154|N|pulse, blood pressure, EKG) may be done while you are taking this||
3225|155|N|medication. Keep all medical and lab appointments. Consult your||
3225|156|N|doctor for more details.||
3225|157|N|   There are different brands and types of this medication||
3225|158|N|available. Many do not have the same effects. Do not change||
3225|159|N|brands or types without consulting your doctor or pharmacist.||
3225|160|N|   Have your blood pressure and pulse checked regularly while||
3225|161|N|taking this medication. Learn how to check your own blood||
3225|162|N|pressure and pulse at home, and share the results with your||
3225|163|N|doctor.||
3225|164|B|||
3225|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3225|166|D|remember. If it is near the time of the next dose, skip the||
3225|167|D|missed dose. Take your next dose at the regular time. Do not||
3225|168|D|double the dose to catch up.||
3225|169|B|||
3225|170|R|STORAGE:  Store at room temperature away from light and moisture.||
3225|171|R|Do not store in the bathroom. Keep all medications away from||
3225|172|R|children and pets.||
3225|173|R|   Do not flush medications down the toilet or pour them into a||
3225|174|R|drain unless instructed to do so. Properly discard this product||
3225|175|R|when it is expired or no longer needed. Consult your pharmacist||
3225|176|R|or local waste disposal company.||
3225|177|B|||
3225|178|M|MEDICAL ALERT:  Your condition can cause complications in a||
3225|179|M|medical emergency. For information about enrolling in MedicAlert,||
3225|180|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3225|181|B|||
3225|182|A|Information last revised March 2025.||
3225|183|A|Copyright(c) 2025 First Databank, Inc.||
3225|184|B|||
3235|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3235|002|Z|does NOT have all possible information about this product. This||
3235|003|Z|information does not assure that this product is safe, effective,||
3235|004|Z|or appropriate for you. This information is not individual||
3235|005|Z|medical advice and does not substitute for the advice of your||
3235|006|Z|health care professional. Always ask your health care||
3235|007|Z|professional for complete information about this product and your||
3235|008|Z|specific health needs.||
3235|009|B|||
3235|010|T|CIPROFLOXACIN OINTMENT - OPHTHALMIC||
3235|011|F|(SIP-roe-FLOX-a-sin)||
3235|012|B|||
3235|013|C|COMMON BRAND NAME(S): Ciloxan||
3235|014|B|||
3235|015|U|USES:  This medication is used to treat eye infections.||
3235|016|U|Ciprofloxacin belongs to a class of drugs called quinolone||
3235|017|U|antibiotics. It works by stopping the growth of bacteria.||
3235|018|U|   This medication treats only bacterial eye infections. It will||
3235|019|U|not work for other types of eye infections. Unnecessary use or||
3235|020|U|overuse of any antibiotic can lead to its decreased||
3235|021|U|effectiveness.||
3235|022|B|||
3235|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
3235|024|H|directed by your doctor, usually 3 times a day for the first 2||
3235|025|H|days and then 2 times a day for the next 5 days.||
3235|026|H|   Do not wear contact lenses while you are using this medicine.||
3235|027|H|Sterilize contact lenses according to manufacturer's directions||
3235|028|H|and check with your doctor before using them.||
3235|029|H|   To apply eye ointments, wash hands first. To avoid||
3235|030|H|contamination, do not touch the tube tip or let it touch your eye||
3235|031|H|or any other surface. Tilt your head back, look upward, and||
3235|032|H|gently pull down the lower eyelid to make a pouch. Place a||
3235|033|H|one-half inch (1.5-centimeters) strip of ointment into the pouch.||
3235|034|H|Gently close the eye and roll the eyeball in all directions to||
3235|035|H|spread the medication. Try not to blink or rub your eye. Repeat||
3235|036|H|these steps for your other eye if so directed.||
3235|037|H|   Wipe the tip of the ointment tube with a clean tissue to||
3235|038|H|remove excess medication before recapping it.||
3235|039|H|   If you are using another kind of eye medication (such as drops||
3235|040|H|or other ointments), wait at least 5 minutes before applying||
3235|041|H|other medications. Use eye drops before eye ointments to allow||
3235|042|H|the eye drops to enter the eye.||
3235|043|H|   Wait several minutes for your vision to clear before driving||
3235|044|H|or operating machinery.||
3235|045|H|   Use this medication regularly in order to get the most benefit||
3235|046|H|from it. Continue to use this medication for the full time||
3235|047|H|prescribed, even if symptoms disappear after a few days. Stopping||
3235|048|H|the medication too early may result in a return of the infection.||
3235|049|H|   Tell your doctor if your condition lasts or gets worse.||
3235|050|B|||
3235|051|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
3235|052|S|eyes for a minute or two when applied. Blurred vision, eye||
3235|053|S|discomfort, itching, redness, tearing, dry eyes, feeling as if||
3235|054|S|something is in your eye, a bad taste in your mouth, or||
3235|055|S|sensitivity to light may occur. If any of these effects last or||
3235|056|S|get worse, notify your doctor or pharmacist promptly.||
3235|057|S|   White crystals may appear in the treated eye(s) after the||
3235|058|S|first few days of ciprofloxacin use, but they usually go away in||
3235|059|S|a few weeks. This effect is harmless. Keep your scheduled||
3235|060|S|appointments so your doctor can closely monitor your eye||
3235|061|S|infection. If you notice any new or worsening eye symptoms (such||
3235|062|S|as increased discharge, eye pain), tell your doctor right away.||
3235|063|S|   Remember that this medication has been prescribed because your||
3235|064|S|doctor has judged that the benefit to you is greater than the||
3235|065|S|risk of side effects. Many people using this medication do not||
3235|066|S|have serious side effects.||
3235|067|S|   Use of this medication for prolonged or repeated periods may||
3235|068|S|result in a new fungal eye infection. Do not use it for longer||
3235|069|S|than prescribed. Contact your doctor if you notice new or||
3235|070|S|worsening symptoms.||
3235|071|S|   Tell your doctor right away if you have any serious side||
3235|072|S|effects, including: staining of the eye, swelling in or around||
3235|073|S|the eye, eye pain, worsening vision.||
3235|074|S|   A very serious allergic reaction to this drug is rare.||
3235|075|S|However, get medical help right away if you notice any symptoms||
3235|076|S|of a serious allergic reaction, including: rash, itching/swelling||
3235|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3235|078|S|breathing.||
3235|079|S|   This is not a complete list of possible side effects. If you||
3235|080|S|notice other effects not listed above, contact your doctor or||
3235|081|S|pharmacist.||
3235|082|S|   In the US -||
3235|083|S|   Call your doctor for medical advice about side effects. You||
3235|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3235|085|S|www.fda.gov/medwatch.||
3235|086|S|   In Canada - Call your doctor for medical advice about side||
3235|087|S|effects. You may report side effects to Health Canada at||
3235|088|S|1-866-234-2345.||
3235|089|B|||
3235|090|P|PRECAUTIONS:  Before using ciprofloxacin, tell your doctor or||
3235|091|P|pharmacist if you are allergic to it; or to other quinolones||
3235|092|P|(such as levofloxacin, moxifloxacin); or if you have any other||
3235|093|P|allergies. This product may contain inactive ingredients, which||
3235|094|P|can cause allergic reactions or other problems. Talk to your||
3235|095|P|pharmacist for more details.||
3235|096|P|   Before using this medication, tell your doctor or pharmacist||
3235|097|P|your medical history, especially of: other eye problems.||
3235|098|P|   After you apply this drug, your vision may become temporarily||
3235|099|P|blurred or unstable. Do not drive, use machinery, or do anything||
3235|100|P|that needs clear vision until you can do it safely.||
3235|101|P|   During pregnancy, this medication should be used only when||
3235|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
3235|103|P|   It is unknown if this medication passes into breast milk.||
3235|104|P|Consult your doctor before breastfeeding.||
3235|105|B|||
3235|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3235|107|I|medications work or increase your risk for serious side effects.||
3235|108|I|This document does not contain all possible drug interactions.||
3235|109|I|Keep a list of all the products you use (including||
3235|110|I|prescription/nonprescription drugs and herbal products) and share||
3235|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
3235|112|I|the dosage of any medicines without your doctor's approval.||
3235|113|B|||
3235|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3235|115|O|has overdosed and has serious symptoms such as passing out or||
3235|116|O|trouble breathing, call 911. Otherwise, call a poison control||
3235|117|O|center right away. US residents can call 1-800-222-1222. Canada||
3235|118|O|residents can call 1-844-764-7669.||
3235|119|B|||
3235|120|N|NOTES:  Do not share this medication with others.||
3235|121|N|   This medication has been prescribed for your current condition||
3235|122|N|only. Throw away the unused medication after treatment is||
3235|123|N|completed. Do not use it later for another infection unless your||
3235|124|N|doctor tells you to.||
3235|125|B|||
3235|126|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3235|127|D|If it is near the time of the next dose, skip the missed dose.||
3235|128|D|Use your next dose at the regular time. Do not double the dose to||
3235|129|D|catch up.||
3235|130|B|||
3235|131|R|STORAGE:  Store at room temperature or in the refrigerator. Do||
3235|132|R|not freeze. Keep all medications away from children and pets.||
3235|133|R|   Do not flush medications down the toilet or pour them into a||
3235|134|R|drain unless instructed to do so. Properly discard this product||
3235|135|R|when it is expired or no longer needed. Consult your pharmacist||
3235|136|R|or local waste disposal company.||
3235|137|B|||
3235|138|A|Information last revised May 2024.||
3235|139|A|Copyright(c) 2025 First Databank, Inc.||
3235|140|B|||
3241|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3241|002|Z|does NOT have all possible information about this product. This||
3241|003|Z|information does not assure that this product is safe, effective,||
3241|004|Z|or appropriate for you. This information is not individual||
3241|005|Z|medical advice and does not substitute for the advice of your||
3241|006|Z|health care professional. Always ask your health care||
3241|007|Z|professional for complete information about this product and your||
3241|008|Z|specific health needs.||
3241|009|B|||
3241|010|T|PENTOSAN POLYSULFATE SODIUM - ORAL||
3241|011|F|(PEN-toe-san paw-lee-SULL-fate SO-dee-um)||
3241|012|B|||
3241|013|C|COMMON BRAND NAME(S): Elmiron||
3241|014|B|||
3241|015|U|USES:  This medication is used to treat pain/discomfort from a||
3241|016|U|certain bladder disorder (interstitial cystitis). It may work by||
3241|017|U|forming a layer on the bladder wall and protecting it from||
3241|018|U|harmful/irritating substances in the urine. It is also a weak||
3241|019|U|"blood thinner" and may increase the risk of bruising/bleeding||
3241|020|U|(such as bleeding from the nose/gums).||
3241|021|B|||
3241|022|H|HOW TO USE:  Read the Medication Guide provided by your||
3241|023|H|pharmacist before you start taking pentosan polysulfate sodium||
3241|024|H|and each time you get a refill. If you have any questions, ask||
3241|025|H|your doctor or pharmacist.||
3241|026|H|   Take this medication by mouth at least 1 hour before or 2||
3241|027|H|hours after meals as directed by your doctor, usually 3 times||
3241|028|H|daily.||
3241|029|H|   Use this medication regularly to get the most benefit from it.||
3241|030|H|To help you remember, take it at the same times each day.||
3241|031|H|   Do not increase your dose or take this medication more often||
3241|032|H|or for longer than prescribed. Your condition will not improve||
3241|033|H|any faster, and your risk of side effects will increase.||
3241|034|H|   Tell your doctor if your condition gets worse or if it does||
3241|035|H|not get better after 3 months.||
3241|036|B|||
3241|037|S|SIDE EFFECTS:  Diarrhea, hair loss, nausea, headache, stomach||
3241|038|S|upset, or abdominal pain may occur. If any of these effects last||
3241|039|S|or get worse, tell your doctor or pharmacist promptly.||
3241|040|S|   Remember that this medication has been prescribed because your||
3241|041|S|doctor has judged that the benefit to you is greater than the||
3241|042|S|risk of side effects. Many people using this medication do not||
3241|043|S|have serious side effects.||
3241|044|S|   Tell your doctor right away if you have any serious side||
3241|045|S|effects, including: unusual bruising/bleeding (such as blood in||
3241|046|S|stool), vision changes (such as blurred vision), eye pain,||
3241|047|S|mental/mood changes, heartburn, discomfort when swallowing,||
3241|048|S|tiredness, fast/pounding heartbeat, shortness of breath.||
3241|049|S|   A very serious allergic reaction to this drug is rare.||
3241|050|S|However, get medical help right away if you notice any symptoms||
3241|051|S|of a serious allergic reaction, including: rash, itching/swelling||
3241|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3241|053|S|breathing.||
3241|054|S|   This is not a complete list of possible side effects. If you||
3241|055|S|notice other effects not listed above, contact your doctor or||
3241|056|S|pharmacist.||
3241|057|S|   In the US -||
3241|058|S|   Call your doctor for medical advice about side effects. You||
3241|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3241|060|S|www.fda.gov/medwatch.||
3241|061|S|   In Canada - Call your doctor for medical advice about side||
3241|062|S|effects. You may report side effects to Health Canada at||
3241|063|S|1-866-234-2345.||
3241|064|B|||
3241|065|P|PRECAUTIONS:  Before taking pentosan polysulfate sodium, tell||
3241|066|P|your doctor or pharmacist if you are allergic to it; or to||
3241|067|P|heparin or low molecular weight heparin; or if you have any other||
3241|068|P|allergies. This product may contain inactive ingredients, which||
3241|069|P|can cause allergic reactions or other problems. Talk to your||
3241|070|P|pharmacist for more details.||
3241|071|P|   Before using this medication, tell your doctor or pharmacist||
3241|072|P|your medical history, especially of: bleeding disorders (such as||
3241|073|P|hemophilia, thrombocytopenia), blood vessel disorders (such as||
3241|074|P|aneurysm), eye disorders, liver disease, spleen disorders,||
3241|075|P|stomach/intestinal disorders (such as stomach ulcers, polyps,||
3241|076|P|diverticula).||
3241|077|P|   Before having surgery, tell your doctor or dentist about all||
3241|078|P|the products you use (including prescription drugs,||
3241|079|P|nonprescription drugs, and herbal products).||
3241|080|P|   During pregnancy, this medication should be used only when||
3241|081|P|clearly needed. Discuss the risks and benefits with your doctor.||
3241|082|P|   It is unknown if this drug passes into breast milk. Consult||
3241|083|P|your doctor before breastfeeding.||
3241|084|B|||
3241|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3241|086|I|medications work or increase your risk for serious side effects.||
3241|087|I|This document does not contain all possible drug interactions.||
3241|088|I|Keep a list of all the products you use (including||
3241|089|I|prescription/nonprescription drugs and herbal products) and share||
3241|090|I|it with your doctor and pharmacist. Do not start, stop, or change||
3241|091|I|the dosage of any medicines without your doctor's approval.||
3241|092|I|   Some products that may interact with this drug include: "blood||
3241|093|I|thinners" (such as warfarin, heparin, rivaroxaban, clopidogrel),||
3241|094|I|mifepristone.||
3241|095|I|   Check all prescription and nonprescription medicine labels||
3241|096|I|carefully since many contain pain relievers/fever reducers||
3241|097|I|(NSAIDs such as aspirin, ibuprofen, naproxen, ketorolac) that may||
3241|098|I|increase your risk for side effects if taken together with this||
3241|099|I|medication. However, if your doctor has told you to take low-dose||
3241|100|I|aspirin to prevent heart attack or stroke (usually 81-162||
3241|101|I|milligrams a day), you should keep taking the aspirin unless your||
3241|102|I|doctor tells you not to. Ask your doctor or pharmacist for more||
3241|103|I|details.||
3241|104|I|   This medication may interfere with certain lab tests (such as||
3241|105|I|prothrombin time/INR, factor Xa levels), possibly causing false||
3241|106|I|test results. Make sure lab personnel and all your doctors know||
3241|107|I|you use this drug.||
3241|108|B|||
3241|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3241|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3241|111|O|poison control center right away. US residents can call||
3241|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3241|113|O|Symptoms of overdose may include: unusual bruising/bleeding,||
3241|114|O|nausea/vomiting.||
3241|115|B|||
3241|116|N|NOTES:  Do not share this medication with others.||
3241|117|N|   Lab and/or medical tests (such as eye exams, liver function)||
3241|118|N|may be done while you are taking this medication. Keep all||
3241|119|N|medical and lab appointments. Consult your doctor for more||
3241|120|N|details.||
3241|121|B|||
3241|122|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3241|123|D|remember. If it is near the time of the next dose, skip the||
3241|124|D|missed dose. Take your next dose at the regular time. Do not||
3241|125|D|double the dose to catch up.||
3241|126|B|||
3241|127|R|STORAGE:  Store at room temperature away from light and moisture.||
3241|128|R|Do not store in the bathroom. Keep all medications away from||
3241|129|R|children and pets.||
3241|130|R|   Do not flush medications down the toilet or pour them into a||
3241|131|R|drain unless instructed to do so. Properly discard this product||
3241|132|R|when it is expired or no longer needed. Consult your pharmacist||
3241|133|R|or local waste disposal company.||
3241|134|B|||
3241|135|A|Information last revised April 2025.||
3241|136|A|Copyright(c) 2025 First Databank, Inc.||
3241|137|B|||
3244|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3244|002|Z|does NOT have all possible information about this product. This||
3244|003|Z|information does not assure that this product is safe, effective,||
3244|004|Z|or appropriate for you. This information is not individual||
3244|005|Z|medical advice and does not substitute for the advice of your||
3244|006|Z|health care professional. Always ask your health care||
3244|007|Z|professional for complete information about this product and your||
3244|008|Z|specific health needs.||
3244|009|B|||
3244|010|T|MIDAZOLAM - INJECTION||
3244|011|F|(mi-DAZ-oh-lam)||
3244|012|B|||
3244|013|C|COMMON BRAND NAME(S): Versed||
3244|014|B|||
3244|015|W|WARNING:  Giving midazolam by injection into a vein can sometimes||
3244|016|W|cause severe breathing problems which could rarely lead to brain||
3244|017|W|damage or be fatal. The risk of serious breathing problems is||
3244|018|W|higher with high doses or if midazolam is given too quickly into||
3244|019|W|a vein. Midazolam must be used only under close medical||
3244|020|W|supervision.||
3244|021|W|   Infants, children, older adults, or weak patients are more||
3244|022|W|sensitive to the effects of midazolam. Lower doses should be used||
3244|023|W|for these patients. Lower doses of midazolam should be used if a||
3244|024|W|patient is also receiving other medications that cause||
3244|025|W|drowsiness. Newborns must not be given midazolam by rapid||
3244|026|W|injection because of the risk of very serious side effects.||
3244|027|W|   Midazolam has a risk for abuse and addiction, which can lead||
3244|028|W|to overdose and death. Using this medication with alcohol or||
3244|029|W|other drugs that can cause drowsiness or breathing problems||
3244|030|W|(especially opioid medications such as codeine, hydrocodone) may||
3244|031|W|cause very serious side effects, including death. To lower your||
3244|032|W|risk, your doctor should have you use the smallest dose of||
3244|033|W|midazolam that works, and use it for the shortest possible time.||
3244|034|W|Be sure you know how to use midazolam and what other drugs you||
3244|035|W|should avoid taking with it. See also Drug Interactions section.||
3244|036|W|Get medical help right away if any of these very serious side||
3244|037|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
3244|038|W|severe drowsiness/dizziness, difficulty waking up.||
3244|039|W|   Suddenly stopping this medication may cause serious (possibly||
3244|040|W|fatal) withdrawal, especially if you have used it for a long time||
3244|041|W|or in high doses. To prevent withdrawal, your doctor may lower||
3244|042|W|your dose slowly. Tell your doctor or pharmacist right away if||
3244|043|W|you have any withdrawal symptoms such as headaches, trouble||
3244|044|W|sleeping, restlessness, hallucinations/confusion, depression,||
3244|045|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
3244|046|W|to months.||
3244|047|B|||
3244|048|U|USES:  Midazolam is used before surgery or a procedure. It helps||
3244|049|U|to cause drowsiness, decrease anxiety, and to decrease your||
3244|050|U|memory of the surgery or procedure. This medication may also be||
3244|051|U|used to help with anesthesia or to sedate people who need a tube||
3244|052|U|or machine to help with breathing. Midazolam works by calming the||
3244|053|U|brain and nerves. It belongs to a class of drugs known as||
3244|054|U|benzodiazepines.||
3244|055|B|||
3244|056|V|OTHER USES:  This section contains uses of this drug that are not||
3244|057|V|listed in the approved professional labeling for the drug but||
3244|058|V|that may be prescribed by your health care professional. Use this||
3244|059|V|drug for a condition that is listed in this section only if it||
3244|060|V|has been so prescribed by your health care professional.||
3244|061|V|   This drug may also be used for serious seizures that do not||
3244|062|V|stop (status epilepticus).||
3244|063|B|||
3244|064|H|HOW TO USE:  See also Warning section.||
3244|065|H|   This medication is given by slow injection into a vein or||
3244|066|H|muscle as directed by your doctor. It is usually given by a||
3244|067|H|health care professional. The dosage is based on your medical||
3244|068|H|condition, type of procedure you are having, other medications||
3244|069|H|you are receiving, age, weight, and response to treatment.||
3244|070|H|   If you are using this medication at home, learn all||
3244|071|H|preparation and usage instructions from your health care||
3244|072|H|professional. Giving this medication too fast into a vein can||
3244|073|H|cause serious side effects. Before using, check this product for||
3244|074|H|particles or discoloration. If either is present, do not use the||
3244|075|H|liquid. Learn how to store and discard medical supplies safely.||
3244|076|H|   When this medication is used for a long time, it may not work||
3244|077|H|as well. Talk with your doctor if this medication stops working||
3244|078|H|well.||
3244|079|H|   Though it helps many people, this medication may sometimes||
3244|080|H|cause addiction. This risk may be higher if you have a substance||
3244|081|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
3244|082|H|Take this medication exactly as prescribed to lower the risk of||
3244|083|H|addiction. Ask your doctor or pharmacist for more details.||
3244|084|B|||
3244|085|S|SIDE EFFECTS:  See also Warning section.||
3244|086|S|   Pain/redness at the injection site or dizziness may occur. If||
3244|087|S|any of these effects last or get worse, tell your doctor or||
3244|088|S|pharmacist promptly.||
3244|089|S|   Remember that this medication has been prescribed because your||
3244|090|S|doctor has judged that the benefit to you is greater than the||
3244|091|S|risk of side effects. Many people using this medication do not||
3244|092|S|have serious side effects.||
3244|093|S|   Tell your doctor right away if you have any serious side||
3244|094|S|effects, including: mental/mood changes (such as agitation,||
3244|095|S|aggressive behavior), shaking, uncontrolled movements, low blood||
3244|096|S|pressure.||
3244|097|S|   Get medical help right away if you have any very serious side||
3244|098|S|effects, including: slow/shallow breathing, seizures.||
3244|099|S|   A very serious allergic reaction to this drug is rare.||
3244|100|S|However, get medical help right away if you notice any symptoms||
3244|101|S|of a serious allergic reaction, including: rash, itching/swelling||
3244|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3244|103|S|breathing.||
3244|104|S|   This is not a complete list of possible side effects. If you||
3244|105|S|notice other effects not listed above, contact your doctor or||
3244|106|S|pharmacist.||
3244|107|S|   In the US -||
3244|108|S|   Call your doctor for medical advice about side effects. You||
3244|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3244|110|S|www.fda.gov/medwatch.||
3244|111|S|   In Canada - Call your doctor for medical advice about side||
3244|112|S|effects. You may report side effects to Health Canada at||
3244|113|S|1-866-234-2345.||
3244|114|B|||
3244|115|P|PRECAUTIONS:  See also Warning section.||
3244|116|P|   Before using midazolam, tell your doctor or pharmacist if you||
3244|117|P|are allergic to it; or to other benzodiazepines (such as||
3244|118|P|diazepam, lorazepam); or if you have any other allergies. This||
3244|119|P|product may contain inactive ingredients which can cause allergic||
3244|120|P|reactions or other problems. Talk to your pharmacist for more||
3244|121|P|details.||
3244|122|P|   Before using this medication, tell your doctor or pharmacist||
3244|123|P|your medical history, especially of: glaucoma, heart failure,||
3244|124|P|kidney disease, liver disease, breathing problems (such as||
3244|125|P|chronic obstructive lung disease-COPD, sleep apnea), personal or||
3244|126|P|family history of a substance use disorder (such as overuse of or||
3244|127|P|addiction to drugs/alcohol).||
3244|128|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3244|129|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3244|130|P|machinery, or do anything that needs alertness until you can do||
3244|131|P|it safely, or until 24 hours after anesthesia and surgery,||
3244|132|P|whichever is longer. Avoid alcoholic beverages. Talk to your||
3244|133|P|doctor if you are using marijuana (cannabis).||
3244|134|P|   Before having surgery, tell your doctor or dentist about all||
3244|135|P|the products you use (including prescription drugs,||
3244|136|P|nonprescription drugs, and herbal products).||
3244|137|P|   Infants and children younger than 3 years using anesthesia or||
3244|138|P|drugs for sedation (including midazolam) for procedures/surgeries||
3244|139|P|may be at risk for slower brain growth. Talk to the doctor about||
3244|140|P|the risks and benefits of this medication.||
3244|141|P|   Tell your doctor if you are pregnant or plan to become||
3244|142|P|pregnant. You should not become pregnant while using midazolam.||
3244|143|P|Midazolam may harm an unborn baby. Newborn babies of mothers who||
3244|144|P|receive this medication late in pregnancy may have symptoms such||
3244|145|P|as slow/shallow breathing, nonstop crying, shaking, or trouble||
3244|146|P|feeding. If you become pregnant, talk to your doctor right away||
3244|147|P|about the risks and benefits of this medication.||
3244|148|P|   This drug passes into breast milk. Consult your doctor before||
3244|149|P|breastfeeding.||
3244|150|B|||
3244|151|I|DRUG INTERACTIONS:  See also Warning section.||
3244|152|I|   Drug interactions may change how your medications work or||
3244|153|I|increase your risk for serious side effects. This document does||
3244|154|I|not contain all possible drug interactions. Keep a list of all||
3244|155|I|the products you use (including prescription/nonprescription||
3244|156|I|drugs and herbal products) and share it with your doctor and||
3244|157|I|pharmacist. Do not start, stop, or change the dosage of any||
3244|158|I|medicines without your doctor's approval.||
3244|159|I|   Some products that may interact with this drug are:||
3244|160|I|conivaptan, HIV protease inhibitors (such as atazanavir),||
3244|161|I|lonafarnib, ritonavir, sodium oxybate.||
3244|162|I|   The risk of serious side effects (such as slow/shallow||
3244|163|I|breathing, severe drowsiness/dizziness) may be increased if this||
3244|164|I|medication is used with other products that may also cause||
3244|165|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
3244|166|I|if you are taking other products such as opioid pain or cough||
3244|167|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3244|168|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
3244|169|I|diazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3244|170|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
3244|171|I|diphenhydramine).||
3244|172|I|   Check the labels on all your medicines (such as allergy or||
3244|173|I|cough-and-cold products) because they may contain ingredients||
3244|174|I|that cause drowsiness. Ask your pharmacist about using those||
3244|175|I|products safely.||
3244|176|B|||
3244|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3244|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3244|179|O|poison control center right away. US residents can call||
3244|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3244|181|O|Symptoms of overdose may include: confusion, slow reflexes,||
3244|182|O|clumsiness, slow/shallow breathing, deep sleep, coma.||
3244|183|B|||
3244|184|N|NOTES:  Do not share this medication with others. Sharing it is||
3244|185|N|against the law.||
3244|186|N|   Medical tests (such as breathing rate, blood pressure, oxygen||
3244|187|N|saturation) should be done while you are using this medication.||
3244|188|N|Consult your doctor for more details.||
3244|189|B|||
3244|190|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
3244|191|D|right away for a new dosing schedule. Do not double the dose to||
3244|192|D|catch up.||
3244|193|B|||
3244|194|R|STORAGE:  Check the product package for instructions on how to||
3244|195|R|store this medication, or ask your pharmacist. Keep all||
3244|196|R|medications away from children and pets.||
3244|197|R|   Do not flush medications down the toilet or pour them into a||
3244|198|R|drain unless instructed to do so. Properly discard this product||
3244|199|R|when it is expired or no longer needed. Consult your pharmacist||
3244|200|R|or local waste disposal company.||
3244|201|B|||
3244|202|A|Information last revised November 2024.||
3244|203|A|Copyright(c) 2025 First Databank, Inc.||
3244|204|B|||
3245|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3245|002|Z|does NOT have all possible information about this product. This||
3245|003|Z|information does not assure that this product is safe, effective,||
3245|004|Z|or appropriate for you. This information is not individual||
3245|005|Z|medical advice and does not substitute for the advice of your||
3245|006|Z|health care professional. Always ask your health care||
3245|007|Z|professional for complete information about this product and your||
3245|008|Z|specific health needs.||
3245|009|B|||
3245|010|T|HYDROCORTISONE CREAM, OINTMENT- RECTAL||
3245|011|F|(HYE-droe-KOR-ti-sone)||
3245|012|B|||
3245|013|C|COMMON BRAND NAME(S): Anusol-HC, Proctocream-HC, Proctosol HC||
3245|014|B|||
3245|015|U|USES:  This medication is used to treat minor pain, itching,||
3245|016|U|swelling, and discomfort caused by hemorrhoids and other problems||
3245|017|U|of the anal area (such as anal fissures, itching). Hydrocortisone||
3245|018|U|is a corticosteroid that reduces redness, itching, and swelling.||
3245|019|B|||
3245|020|H|HOW TO USE:  Before use, clean the affected area with mild soap||
3245|021|H|and water, rinse well, and pat dry.||
3245|022|H|   To apply this product inside the anus, use the applicator||
3245|023|H|tip/cap/nozzle, following all instructions in the product||
3245|024|H|package, or use as directed by your doctor. Fill the applicator||
3245|025|H|with medication from the container as directed. Gently insert the||
3245|026|H|applicator tip just 1/2 to 1 inch (1.5 to 2.5 centimeters) inside||
3245|027|H|the anus and apply in and around the anal opening as directed. Do||
3245|028|H|not insert your finger or any part of the container into the||
3245|029|H|anus, and do not insert the applicator tip/nozzle more than 1/2||
3245|030|H|to 1 inch (1.5 to 2.5 centimeters) inside the anus. Do not use||
3245|031|H|your finger to apply this medication inside the anus. If you are||
3245|032|H|using a single-use tube and applicator, discard after one use.||
3245|033|H|   To apply the product to the outside of the anus only, use your||
3245|034|H|finger to apply a small amount of cream or ointment to the||
3245|035|H|affected area and rub in gently.||
3245|036|H|   Do not cover the area with plastic or waterproof bandages||
3245|037|H|unless directed to do so by your doctor. Covering the treated||
3245|038|H|area may increase the absorption of the medication through the||
3245|039|H|skin. This may improve how well the drug works, but it may also||
3245|040|H|increase the risk of side effects.||
3245|041|H|   Wash hands immediately after use. Avoid getting the product in||
3245|042|H|your eyes, nose, ears or mouth. If the medication gets in these||
3245|043|H|areas, rinse the area immediately with clean water.||
3245|044|H|   This product is usually used 2 to 4 times daily, or after each||
3245|045|H|bowel movement, or as directed by your doctor. The dosage is||
3245|046|H|based on your medical condition and response to treatment. Use||
3245|047|H|this medication regularly in order to get the most benefit from||
3245|048|H|it. To help you remember, use it at the same times each day.||
3245|049|H|   Do not use more of this product, use it more often, or keep||
3245|050|H|using it longer than prescribed by your doctor. If you have been||
3245|051|H|using this medication for a long time or in high doses, do not||
3245|052|H|suddenly stop using it without your doctor's approval. Some||
3245|053|H|conditions may become worse when this drug is suddenly stopped.||
3245|054|H|Your dose may need to be gradually decreased.||
3245|055|H|   Tell your doctor if your condition does not get better or if||
3245|056|H|it gets worse after 1 to 2 weeks.||
3245|057|B|||
3245|058|S|SIDE EFFECTS:  Redness, burning, or itching at the application||
3245|059|S|site may occur. If any of these effects last or get worse, tell||
3245|060|S|your doctor or pharmacist promptly.||
3245|061|S|   If your doctor has directed you to use this medication,||
3245|062|S|remember that your doctor has judged that the benefit to you is||
3245|063|S|greater than the risk of side effects. Many people using this||
3245|064|S|medication do not have serious side effects.||
3245|065|S|   Tell your doctor right away if you have any serious side||
3245|066|S|effects, including: rectal bleeding, change in skin appearance||
3245|067|S|(such as color, thickness), skin redness/tenderness/pus, signs of||
3245|068|S|infection (such as sore throat that doesn't go away, fever,||
3245|069|S|chills).||
3245|070|S|   Rarely, it is possible this medication will be absorbed into||
3245|071|S|the bloodstream. This can lead to side effects of too much||
3245|072|S|corticosteroid. These side effects are more likely in children||
3245|073|S|and people who use this medication for a long time. Tell your||
3245|074|S|doctor right away if any of the following side effects occur:||
3245|075|S|unusual/extreme tiredness, weight loss, headache, swelling||
3245|076|S|ankles/feet, increased thirst/urination, vision problems.||
3245|077|S|   A very serious allergic reaction to this drug is rare.||
3245|078|S|However, get medical help right away if you notice any symptoms||
3245|079|S|of a serious allergic reaction, including: rash, itching/swelling||
3245|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3245|081|S|breathing.||
3245|082|S|   This is not a complete list of possible side effects. If you||
3245|083|S|notice other effects not listed above, contact your doctor or||
3245|084|S|pharmacist.||
3245|085|S|   In the US -||
3245|086|S|   Call your doctor for medical advice about side effects. You||
3245|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3245|088|S|www.fda.gov/medwatch.||
3245|089|S|   In Canada - Call your doctor for medical advice about side||
3245|090|S|effects. You may report side effects to Health Canada at||
3245|091|S|1-866-234-2345.||
3245|092|B|||
3245|093|P|PRECAUTIONS:  Before using this product, tell your doctor or||
3245|094|P|pharmacist if you are allergic to hydrocortisone; or if you have||
3245|095|P|any other allergies. This product may contain inactive||
3245|096|P|ingredients, which can cause allergic reactions or other||
3245|097|P|problems. Talk to your pharmacist for more details.||
3245|098|P|   Before using this medication, tell your doctor or pharmacist||
3245|099|P|your medical history, especially of: diabetes, eye problems,||
3245|100|P|infections (especially rectal sores/infections), liver disease,||
3245|101|P|stomach/intestinal problems.||
3245|102|P|   Rarely, using corticosteroid medications for a long time can||
3245|103|P|make it more difficult for your body to respond to physical||
3245|104|P|stress. Before having surgery or emergency treatment, or if you||
3245|105|P|get a serious illness/injury, tell your doctor or dentist that||
3245|106|P|you are using this medication or have used this medication within||
3245|107|P|the past few months.||
3245|108|P|   Though it is unlikely, this medication may temporarily slow||
3245|109|P|down a child's growth if used for a long time. See the doctor||
3245|110|P|regularly so your child's height can be checked.||
3245|111|P|   During pregnancy, this medication should be used only when||
3245|112|P|clearly needed. It should not be used for long periods of time or||
3245|113|P|in large amounts. Discuss the risks and benefits with your||
3245|114|P|doctor.||
3245|115|P|   It is unknown if this medication passes into breast milk.||
3245|116|P|Consult your doctor before breastfeeding.||
3245|117|B|||
3245|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3245|119|I|medications work or increase your risk for serious side effects.||
3245|120|I|This document does not contain all possible drug interactions.||
3245|121|I|Keep a list of all the products you use (including||
3245|122|I|prescription/nonprescription drugs and herbal products) and share||
3245|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
3245|124|I|the dosage of any medicines without your doctor's approval.||
3245|125|I|   A product that may interact with this drug is: desmopressin.||
3245|126|B|||
3245|127|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3245|128|O|has overdosed and has serious symptoms such as passing out or||
3245|129|O|trouble breathing, call 911. Otherwise, call a poison control||
3245|130|O|center right away. US residents can call 1-800-222-1222. Canada||
3245|131|O|residents can call 1-844-764-7669.||
3245|132|B|||
3245|133|N|NOTES:  Lab and/or medical tests (such as cortisol levels) may be||
3245|134|N|done while you are using this medication. Keep all medical and||
3245|135|N|lab appointments. Consult your doctor for more details.||
3245|136|N|   This medication has been prescribed for your current condition||
3245|137|N|only. Do not use it later for another condition unless told to do||
3245|138|N|so by your doctor. A different medication may be necessary in||
3245|139|N|that case.||
3245|140|B|||
3245|141|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
3245|142|D|unless it is almost time for the next dose. In that case, skip||
3245|143|D|the missed dose. Use your next dose at the regular time. Do not||
3245|144|D|double the dose to catch up.||
3245|145|B|||
3245|146|R|STORAGE:  Store at room temperature. Do not refrigerate. Keep all||
3245|147|R|medications away from children and pets.||
3245|148|R|   Do not flush medications down the toilet or pour them into a||
3245|149|R|drain unless instructed to do so. Properly discard this product||
3245|150|R|when it is expired or no longer needed. Consult your pharmacist||
3245|151|R|or local waste disposal company.||
3245|152|B|||
3245|153|A|Information last revised May 2025.||
3245|154|A|Copyright(c) 2025 First Databank, Inc.||
3245|155|B|||
3246|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3246|002|Z|does NOT have all possible information about this product. This||
3246|003|Z|information does not assure that this product is safe, effective,||
3246|004|Z|or appropriate for you. This information is not individual||
3246|005|Z|medical advice and does not substitute for the advice of your||
3246|006|Z|health care professional. Always ask your health care||
3246|007|Z|professional for complete information about this product and your||
3246|008|Z|specific health needs.||
3246|009|B|||
3246|010|T|FACTOR VIIA, RECOMBINANT - INJECTION||
3246|011|F|(factor VIIA,ree-KOM-bin-unt)||
3246|012|B|||
3246|013|C|COMMON BRAND NAME(S): Novoseven, Sevenfact||
3246|014|B|||
3246|015|W|WARNING:  This medication has caused serious (sometimes fatal)||
3246|016|W|problems from blood clots (such as heart attack, stroke, blood||
3246|017|W|clots in the lungs or legs). You may be at increased risk for||
3246|018|W|blood clots if you have a history of blood clots, heart/blood||
3246|019|W|vessel disease, liver disease, or if you are immobile (such as||
3246|020|W|being bedridden after surgery). Talk with your doctor about the||
3246|021|W|risks and benefits of this medication. Get medical help right||
3246|022|W|away if any of these side effects occur: shortness of||
3246|023|W|breath/rapid breathing, chest/jaw/left arm pain, unusual||
3246|024|W|sweating, sudden dizziness/fainting, pain/swelling/warmth in the||
3246|025|W|groin/calf, sudden/severe headaches, sudden vision changes,||
3246|026|W|weakness on one side of the body, trouble speaking, or confusion.||
3246|027|B|||
3246|028|U|USES:  This medication is used to treat and prevent bleeding in||
3246|029|U|people with a certain condition (hemophilia type A or B). Some||
3246|030|U|brands may also be used to treat and prevent bleeding in people||
3246|031|U|with low levels of factor VII or Glanzmann's thrombasthenia.||
3246|032|U|People with these conditions are at risk for bleeding longer||
3246|033|U|after an injury/surgery and for bleeding inside the body||
3246|034|U|(especially into the joints and muscles). This product contains a||
3246|035|U|man-made form of factor VIIa, which is a protein (clotting||
3246|036|U|factor) in the blood that works with other clotting factors to||
3246|037|U|help the blood clot and stop bleeding.||
3246|038|B|||
3246|039|H|HOW TO USE:  Read the Patient Information Leaflet and||
3246|040|H|Instructions for Use leaflet if available from your pharmacist||
3246|041|H|before you start using this medication and each time you get a||
3246|042|H|refill. If you have any questions, ask your doctor or pharmacist.||
3246|043|H|   This medication is given by injection into a vein as directed||
3246|044|H|by your doctor, usually every 2 to 6 hours until no longer||
3246|045|H|needed. The dosage is based on your medical condition, weight,||
3246|046|H|and response to treatment.||
3246|047|H|   If you are giving this medication to yourself at home, learn||
3246|048|H|all preparation and usage instructions from your health care||
3246|049|H|professional. Before using, check this product for particles or||
3246|050|H|discoloration. If either is present, do not use the liquid. Do||
3246|051|H|not shake the vial. Gently swirl the mixture until all the powder||
3246|052|H|has dissolved. Do not mix this medication with any other drugs.||
3246|053|H|Learn how to store and discard medical supplies safely.||
3246|054|H|   Tell your doctor if your condition does not get better or if||
3246|055|H|it gets worse.||
3246|056|B|||
3246|057|S|SIDE EFFECTS:  See also Warning Section.||
3246|058|S|   Fever, headache, pain/redness/irritation at the injection||
3246|059|S|site, dizziness, nausea, or vomiting may occur. If any of these||
3246|060|S|effects last or get worse, tell your doctor or pharmacist||
3246|061|S|promptly.||
3246|062|S|   Remember that this medication has been prescribed because your||
3246|063|S|doctor has judged that the benefit to you is greater than the||
3246|064|S|risk of side effects. Many people using this medication do not||
3246|065|S|have serious side effects.||
3246|066|S|   Tell your doctor right away if you have any serious side||
3246|067|S|effects, including: swelling ankles/feet, new or worsening||
3246|068|S|bleeding/bruising, new or worsening joint pain/swelling,||
3246|069|S|fast/slow heartbeat, signs of kidney problems (such as change in||
3246|070|S|the amount of urine).||
3246|071|S|   A very serious allergic reaction to this drug is rare.||
3246|072|S|However, get medical help right away if you notice any symptoms||
3246|073|S|of a serious allergic reaction, including: rash, itching/swelling||
3246|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3246|075|S|breathing.||
3246|076|S|   This is not a complete list of possible side effects. If you||
3246|077|S|notice other effects not listed above, contact your doctor or||
3246|078|S|pharmacist.||
3246|079|S|   In the US -||
3246|080|S|   Call your doctor for medical advice about side effects. You||
3246|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3246|082|S|www.fda.gov/medwatch.||
3246|083|S|   In Canada - Call your doctor for medical advice about side||
3246|084|S|effects. You may report side effects to Health Canada at||
3246|085|S|1-866-234-2345.||
3246|086|B|||
3246|087|P|PRECAUTIONS:  Before using factor VIIa, tell your doctor or||
3246|088|P|pharmacist if you are allergic to it; or if you have any other||
3246|089|P|allergies. For some brands, also tell your doctor or pharmacist||
3246|090|P|if you are allergic to rabbits or rabbit proteins. This product||
3246|091|P|may contain inactive ingredients, which can cause allergic||
3246|092|P|reactions or other problems. Talk to your pharmacist for more||
3246|093|P|details.||
3246|094|P|   Before using this medication, tell your doctor or pharmacist||
3246|095|P|your medical history, especially of: other bleeding/clotting||
3246|096|P|problems (such as disseminated intravascular coagulation-DIC),||
3246|097|P|blood vessel problems (such as atherosclerosis), recent serious||
3246|098|P|infection in the blood, recent serious injury.||
3246|099|P|   Newborns may be at greater risk for blood clots while using||
3246|100|P|this drug.||
3246|101|P|   Older adults may be at greater risk for blood clots while||
3246|102|P|using this drug.||
3246|103|P|   During pregnancy, this medication should be used only when||
3246|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
3246|105|P|   It is unknown if this drug passes into breast milk. Consult||
3246|106|P|your doctor before breastfeeding.||
3246|107|B|||
3246|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3246|109|I|medications work or increase your risk for serious side effects.||
3246|110|I|This document does not contain all possible drug interactions.||
3246|111|I|Keep a list of all the products you use (including||
3246|112|I|prescription/nonprescription drugs and herbal products) and share||
3246|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
3246|114|I|the dosage of any medicines without your doctor's approval.||
3246|115|I|   This product should not be given at the same time as certain||
3246|116|I|other clotting factor products (activated and non-activated||
3246|117|I|prothrombin complex concentrates).||
3246|118|B|||
3246|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3246|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3246|121|O|poison control center right away. US residents can call||
3246|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3246|123|B|||
3246|124|N|NOTES:  Do not share this medication with others.||
3246|125|N|   Lab and/or medical tests (such as clotting time tests, factor||
3246|126|N|VII activity) should be done while you are using this medication.||
3246|127|N|Keep all medical and lab appointments. Consult your doctor for||
3246|128|N|more details.||
3246|129|B|||
3246|130|D|MISSED DOSE:  It is important to get each dose of this medication||
3246|131|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
3246|132|D|right away for a new dosing schedule. Do not double the dose to||
3246|133|D|catch up.||
3246|134|B|||
3246|135|R|STORAGE:  Consult the product instructions and your pharmacist||
3246|136|R|for storage details. Keep all medications away from children and||
3246|137|R|pets.||
3246|138|R|   Do not flush medications down the toilet or pour them into a||
3246|139|R|drain unless instructed to do so. Properly discard this product||
3246|140|R|when it is expired or no longer needed. Consult your pharmacist||
3246|141|R|or local waste disposal company.||
3246|142|B|||
3246|143|M|MEDICAL ALERT:  Your condition can cause complications in a||
3246|144|M|medical emergency. For information about enrolling in MedicAlert,||
3246|145|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3246|146|B|||
3246|147|A|Information last revised March 2025.||
3246|148|A|Copyright(c) 2025 First Databank, Inc.||
3246|149|B|||
3247|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3247|002|Z|does NOT have all possible information about this product. This||
3247|003|Z|information does not assure that this product is safe, effective,||
3247|004|Z|or appropriate for you. This information is not individual||
3247|005|Z|medical advice and does not substitute for the advice of your||
3247|006|Z|health care professional. Always ask your health care||
3247|007|Z|professional for complete information about this product and your||
3247|008|Z|specific health needs.||
3247|009|B|||
3247|010|T|SALBUTAMOL (ALBUTEROL) DISK INHALER - ORAL INHALATION||
3247|011|F|(sal-BUE-ta-mol/al-BUE-ter-ol)||
3247|012|B|||
3247|013|U|USES:  Salbutamol (also known as albuterol) is used to prevent||
3247|014|U|and treat wheezing and shortness of breath caused by breathing||
3247|015|U|problems (such as asthma, chronic obstructive pulmonary disease).||
3247|016|U|It is also used to prevent asthma brought on by exercise. It is a||
3247|017|U|quick-relief medication. Salbutamol belongs to a class of drugs||
3247|018|U|known as bronchodilators. It works by relaxing the muscles around||
3247|019|U|the airways so that they open up and you can breathe more easily.||
3247|020|U|Controlling symptoms of breathing problems can decrease time lost||
3247|021|U|from work or school.||
3247|022|B|||
3247|023|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
3247|024|H|your pharmacist before you start using this medication and each||
3247|025|H|time you get a refill. Follow the illustrated directions for the||
3247|026|H|proper use of this medication and device. For this inhaler to||
3247|027|H|work properly, it is important to keep it dry. If you have any||
3247|028|H|questions, ask your doctor or pharmacist.||
3247|029|H|   This medication is inhaled by mouth as directed by your||
3247|030|H|doctor. Open the inhaler and prepare the dose as directed in the||
3247|031|H|Patient Information Leaflet. Place the mouthpiece near your mouth||
3247|032|H|and breathe out as far as is comfortable. Do not breathe into the||
3247|033|H|inhaler device. Then put the mouthpiece to your lips and breathe||
3247|034|H|in steadily and deeply. Hold your breath for about 10 seconds, or||
3247|035|H|for as long as is comfortable, to allow the drug to be absorbed.||
3247|036|H|   If a child is using this medication, a parent or other||
3247|037|H|responsible adult may need to help the child use the inhaler||
3247|038|H|properly.||
3247|039|H|   If you are using other inhalers at the same time, wait at||
3247|040|H|least 1 minute between the use of each medication.||
3247|041|H|   The dosage is based on your medical condition, age, and||
3247|042|H|response to treatment. If you are using this medication to||
3247|043|H|prevent asthma brought on by exercise, use it 15 minutes before||
3247|044|H|exercise.||
3247|045|H|   Do not increase your dose or use this drug more often than||
3247|046|H|prescribed without your doctor's approval. Using too much of this||
3247|047|H|medication will increase your risk of serious (possibly fatal)||
3247|048|H|side effects.||
3247|049|H|   Keep track of the number of inhalations used from each device.||
3247|050|H|Discard the device after you have used the number of inhalations||
3247|051|H|marked on the manufacturer's package.||
3247|052|H|   Learn which of your inhalers you should use every day||
3247|053|H|(controller drugs) and which you should use if your breathing||
3247|054|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
3247|055|H|time what you should do if you have new or worsening cough or||
3247|056|H|shortness of breath, wheezing, increased sputum, worsening peak||
3247|057|H|flow meter readings, waking up at night with trouble breathing,||
3247|058|H|if you use your quick-relief inhaler more often (more than 2 days||
3247|059|H|a week), or if your quick-relief inhaler does not seem to be||
3247|060|H|working well. Learn when you can treat sudden breathing problems||
3247|061|H|by yourself and when you must get medical help right away.||
3247|062|H|   Tell your doctor if your symptoms do not get better or if they||
3247|063|H|get worse.||
3247|064|B|||
3247|065|S|SIDE EFFECTS:  Nervousness, dizziness, shaking (tremor), trouble||
3247|066|S|sleeping, headache, nausea, dry/irritated mouth or throat, or||
3247|067|S|unusual taste may occur. If any of these effects last or get||
3247|068|S|worse, tell your doctor or pharmacist promptly.||
3247|069|S|   Remember that this medication has been prescribed because your||
3247|070|S|doctor has judged that the benefit to you is greater than the||
3247|071|S|risk of side effects. Many people using this medication do not||
3247|072|S|have serious side effects.||
3247|073|S|   This medication may raise your blood pressure. Check your||
3247|074|S|blood pressure regularly and tell your doctor if the results are||
3247|075|S|high.||
3247|076|S|   Tell your doctor right away if you have any serious side||
3247|077|S|effects, including: fast/pounding heartbeat.||
3247|078|S|   Get medical help right away if you have any very serious side||
3247|079|S|effects, including: chest pain, irregular heartbeat, rapid||
3247|080|S|breathing, confusion.||
3247|081|S|   Rarely, this medication has caused severe (rarely fatal),||
3247|082|S|sudden worsening of breathing problems/asthma (paradoxical||
3247|083|S|bronchospasm). If you experience sudden wheezing, get medical||
3247|084|S|help right away.||
3247|085|S|   A very serious allergic reaction to this drug is rare.||
3247|086|S|However, get medical help right away if you notice any symptoms||
3247|087|S|of a serious allergic reaction, including: rash, itching/swelling||
3247|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3247|089|S|breathing.||
3247|090|S|   This is not a complete list of possible side effects. If you||
3247|091|S|notice other effects not listed above, contact your doctor or||
3247|092|S|pharmacist.||
3247|093|S|   In the US -||
3247|094|S|   Call your doctor for medical advice about side effects. You||
3247|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3247|096|S|www.fda.gov/medwatch.||
3247|097|S|   In Canada - Call your doctor for medical advice about side||
3247|098|S|effects. You may report side effects to Health Canada at||
3247|099|S|1-866-234-2345.||
3247|100|B|||
3247|101|P|PRECAUTIONS:  Before using salbutamol, tell your doctor or||
3247|102|P|pharmacist if you are allergic to it; or to similar drugs (such||
3247|103|P|as levalbuterol, metaproterenol, salmeterol); or if you have any||
3247|104|P|other allergies. This product may contain inactive ingredients||
3247|105|P|(such as lactose, milk proteins), which can cause allergic||
3247|106|P|reactions or other problems. Talk to your pharmacist for more||
3247|107|P|details.||
3247|108|P|   Before using this medication, tell your doctor or pharmacist||
3247|109|P|your medical history, especially of: heart problems (such as||
3247|110|P|irregular heartbeat, angina, previous heart attack), high blood||
3247|111|P|pressure, seizure.||
3247|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3247|113|P|can make you more dizzy. Do not drive, use machinery, or do||
3247|114|P|anything that needs alertness until you can do it safely. Limit||
3247|115|P|alcoholic beverages. Talk to your doctor if you are using||
3247|116|P|marijuana (cannabis).||
3247|117|P|   Before having surgery, tell your doctor or dentist about all||
3247|118|P|the products you use (including prescription drugs,||
3247|119|P|nonprescription drugs, and herbal products).||
3247|120|P|   During pregnancy, this medication should be used only when||
3247|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
3247|122|P|   It is unknown if this drug passes into breast milk. Consult||
3247|123|P|your doctor before breastfeeding.||
3247|124|B|||
3247|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3247|126|I|medications work or increase your risk for serious side effects.||
3247|127|I|This document does not contain all possible drug interactions.||
3247|128|I|Keep a list of all the products you use (including||
3247|129|I|prescription/nonprescription drugs and herbal products) and share||
3247|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
3247|131|I|the dosage of any medicines without your doctor's approval.||
3247|132|I|   Salbutamol is very similar to levalbuterol. Do not use||
3247|133|I|medications containing levalbuterol while using salbutamol.||
3247|134|B|||
3247|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3247|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3247|137|O|poison control center right away. US residents can call||
3247|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3247|139|O|Symptoms of overdose may include: chest pain,||
3247|140|O|fast/pounding/irregular heartbeat, headache, shaking (tremors),||
3247|141|O|nervousness, weakness, severe dizziness, seizures.||
3247|142|B|||
3247|143|N|NOTES:  Do not share this medication with others.||
3247|144|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
3247|145|N|EKG) may be done while you are using this medication. Keep all||
3247|146|N|medical and lab appointments. Consult your doctor for more||
3247|147|N|details.||
3247|148|N|   Avoid allergens/irritants that can worsen breathing problems,||
3247|149|N|such as smoke, pollen, pet dander, dust, or molds.||
3247|150|N|   Learn to use a peak flow meter, use it daily, and promptly||
3247|151|N|report worsening breathing problems (such as readings in the||
3247|152|N|yellow/red range, increased use of quick-relief inhalers).||
3247|153|N|   Because the flu virus can worsen breathing problems, ask your||
3247|154|N|doctor or pharmacist if you should have a flu shot every year.||
3247|155|B|||
3247|156|D|MISSED DOSE:  If you are using salbutamol regularly and miss a||
3247|157|D|dose, use it as soon as you remember. If it is near the time of||
3247|158|D|the next dose, skip the missed dose. Use your next dose at the||
3247|159|D|regular time. Do not double the dose to catch up.||
3247|160|B|||
3247|161|R|STORAGE:  Store at room temperature away from light and moisture.||
3247|162|R|Do not store in the bathroom. Keep all medications away from||
3247|163|R|children and pets.||
3247|164|R|   Do not flush medications down the toilet or pour them into a||
3247|165|R|drain unless instructed to do so. Properly discard this product||
3247|166|R|when it is expired or no longer needed. Consult your pharmacist||
3247|167|R|or local waste disposal company.||
3247|168|B|||
3247|169|M|MEDICAL ALERT:  Your condition can cause complications in a||
3247|170|M|medical emergency. For information about enrolling in MedicAlert,||
3247|171|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3247|172|B|||
3247|173|A|Information last revised October 2024.||
3247|174|A|Copyright(c) 2025 First Databank, Inc.||
3247|175|B|||
3249|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3249|002|Z|does NOT have all possible information about this product. This||
3249|003|Z|information does not assure that this product is safe, effective,||
3249|004|Z|or appropriate for you. This information is not individual||
3249|005|Z|medical advice and does not substitute for the advice of your||
3249|006|Z|health care professional. Always ask your health care||
3249|007|Z|professional for complete information about this product and your||
3249|008|Z|specific health needs.||
3249|009|B|||
3249|010|T|MULTIVITAMINS (INCLUDES PRENATAL VITAMINS) TIME RELEASE - ORAL||
3249|011|B|||
3249|012|W|WARNING:  If your brand of multivitamin contains iron, it is||
3249|013|W|important to keep this product out of reach of children.||
3249|014|W|Accidental overdose of iron-containing products is a leading||
3249|015|W|cause of fatal poisoning in children younger than 6 years. If||
3249|016|W|overdose does occur, get medical help right away or call a poison||
3249|017|W|control center.||
3249|018|B|||
3249|019|U|USES:  This medication is a multivitamin product used to treat or||
3249|020|U|prevent vitamin deficiency due to poor diet, certain illnesses,||
3249|021|U|or during pregnancy. Vitamins are important building blocks of||
3249|022|U|the body and help keep you in good health.||
3249|023|B|||
3249|024|H|HOW TO USE:  Take this medication by mouth, usually once daily or||
3249|025|H|as directed. Follow all directions on the product package, or||
3249|026|H|take as directed by your doctor. Do not take more than the||
3249|027|H|recommended dosage. If you have any questions, ask your doctor or||
3249|028|H|pharmacist.||
3249|029|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
3249|030|H|Doing so can release all of the drug at once, increasing the risk||
3249|031|H|of side effects.||
3249|032|H|   Take this medication regularly in order to get the most||
3249|033|H|benefit from it. To help you remember, take it at the same time||
3249|034|H|each day.||
3249|035|B|||
3249|036|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
3249|037|S|occur. These effects are usually temporary and may disappear as||
3249|038|S|your body adjusts to this medication. If any of these effects||
3249|039|S|last or get worse, contact your doctor or pharmacist promptly.||
3249|040|S|   If your doctor has prescribed this medication, remember that||
3249|041|S|your doctor has judged that the benefit to you is greater than||
3249|042|S|the risk of side effects. Many people using this medication do||
3249|043|S|not have serious side effects.||
3249|044|S|   A very serious allergic reaction to this drug is rare.||
3249|045|S|However, get medical help right away if you notice any symptoms||
3249|046|S|of a serious allergic reaction, including: rash, itching/swelling||
3249|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3249|048|S|breathing.||
3249|049|S|   This is not a complete list of possible side effects. If you||
3249|050|S|notice other effects not listed above, contact your doctor or||
3249|051|S|pharmacist.||
3249|052|S|   In the US -||
3249|053|S|   Call your doctor for medical advice about side effects. You||
3249|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3249|055|S|www.fda.gov/medwatch.||
3249|056|S|   In Canada - Call your doctor for medical advice about side||
3249|057|S|effects. You may report side effects to Health Canada at||
3249|058|S|1-866-234-2345.||
3249|059|B|||
3249|060|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
3249|061|P|pharmacist if you are allergic to any of its ingredients; or if||
3249|062|P|you have any other allergies. This product may contain inactive||
3249|063|P|ingredients, which can cause allergic reactions or other||
3249|064|P|problems. Talk to your pharmacist for more details.||
3249|065|P|   Before taking this medication, tell your doctor or pharmacist||
3249|066|P|your medical history, especially of: use/abuse of alcohol, liver||
3249|067|P|problems, stomach/intestinal problems (such as ulcer, colitis).||
3249|068|P|   If your brand of multivitamin also contains folic acid, be||
3249|069|P|sure to tell your doctor or pharmacist if you have vitamin B12||
3249|070|P|deficiency (pernicious anemia) before taking it. Folic acid may||
3249|071|P|affect certain lab tests for vitamin B12 deficiency without||
3249|072|P|treating this anemia. Untreated vitamin B12 deficiency may result||
3249|073|P|in serious nerve problems (such as peripheral neuropathy).||
3249|074|P|Consult your doctor or pharmacist for details.||
3249|075|P|   Before having surgery, tell your doctor or dentist about all||
3249|076|P|the products you use (including prescription drugs,||
3249|077|P|nonprescription drugs, and herbal products).||
3249|078|P|   Tell your doctor if you are pregnant before using this||
3249|079|P|medication.||
3249|080|P|   This medication passes into breast milk. Consult your doctor||
3249|081|P|before breastfeeding.||
3249|082|B|||
3249|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3249|084|I|medications work or increase your risk for serious side effects.||
3249|085|I|This document does not contain all possible drug interactions.||
3249|086|I|Keep a list of all the products you use (including||
3249|087|I|prescription/nonprescription drugs and herbal products) and share||
3249|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
3249|089|I|the dosage of any medicines without your doctor's approval.||
3249|090|I|   If your brand of multivitamin also contains calcium, iron,||
3249|091|I|magnesium, or zinc, then it can decrease the absorption of||
3249|092|I|certain drugs, especially if you take them around the same time.||
3249|093|I|These drugs include bisphosphonates (such as alendronate),||
3249|094|I|levodopa, penicillamine, quinolone antibiotics (such as||
3249|095|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
3249|096|I|doxycycline, minocycline), thyroid medications (such as||
3249|097|I|levothyroxine), among others. Ask your doctor or pharmacist how||
3249|098|I|long you should wait between doses of this product and your other||
3249|099|I|medications and to find a dosing schedule that works for all your||
3249|100|I|medications.||
3249|101|B|||
3249|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3249|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3249|104|O|poison control center right away. US residents can call||
3249|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3249|106|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
3249|107|O|diarrhea.||
3249|108|B|||
3249|109|N|NOTES:  Keep all medical and lab appointments.||
3249|110|N|   This product is not a substitute for a proper diet. Remember||
3249|111|N|that it is best to get your vitamins from healthy foods. Maintain||
3249|112|N|a well-balanced diet and follow any dietary guidelines as||
3249|113|N|directed by your doctor.||
3249|114|B|||
3249|115|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3249|116|D|remember. If it is near the time of the next dose, skip the||
3249|117|D|missed dose. Take your next dose at the regular time. Do not||
3249|118|D|double the dose to catch up.||
3249|119|B|||
3249|120|R|STORAGE:  Store at room temperature away from light and moisture.||
3249|121|R|Do not store in the bathroom. Keep all medications away from||
3249|122|R|children and pets.||
3249|123|R|   Do not flush medications down the toilet or pour them into a||
3249|124|R|drain unless instructed to do so. Properly discard this product||
3249|125|R|when it is expired or no longer needed. Consult your pharmacist||
3249|126|R|or local waste disposal company.||
3249|127|B|||
3249|128|A|Information last revised October 2025.||
3249|129|A|Copyright(c) 2025 First Databank, Inc.||
3249|130|B|||
3250|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3250|002|Z|does NOT have all possible information about this product. This||
3250|003|Z|information does not assure that this product is safe, effective,||
3250|004|Z|or appropriate for you. This information is not individual||
3250|005|Z|medical advice and does not substitute for the advice of your||
3250|006|Z|health care professional. Always ask your health care||
3250|007|Z|professional for complete information about this product and your||
3250|008|Z|specific health needs.||
3250|009|B|||
3250|010|T|LANSOPRAZOLE DELAYED-RELEASE DISINTEGRATING TABLET - ORAL||
3250|011|F|(lan-SO-pruh-zole)||
3250|012|B|||
3250|013|C|COMMON BRAND NAME(S): Prevacid||
3250|014|B|||
3250|015|U|USES:  Lansoprazole is used to treat certain stomach and||
3250|016|U|esophagus problems (such as acid reflux, ulcers). It works by||
3250|017|U|decreasing the amount of acid your stomach makes. It relieves||
3250|018|U|symptoms such as heartburn, difficulty swallowing, and cough.||
3250|019|U|This medication helps heal acid damage to the stomach and||
3250|020|U|esophagus, helps prevent ulcers, and may help prevent cancer of||
3250|021|U|the esophagus. Lansoprazole belongs to a class of drugs known as||
3250|022|U|proton pump inhibitors (PPIs).||
3250|023|U|   Lansoprazole is not recommended for use in children younger||
3250|024|U|than 1 year due to an increased risk of serious side effects. Ask||
3250|025|U|the doctor or pharmacist for details.||
3250|026|B|||
3250|027|H|HOW TO USE:  Read the Medication Guide and, if available, the||
3250|028|H|Patient Information Leaflet provided by your pharmacist before||
3250|029|H|you start taking lansoprazole and each time you get a refill. If||
3250|030|H|you have any questions, ask your doctor or pharmacist.||
3250|031|H|   Take this medication by mouth before a meal as directed by||
3250|032|H|your doctor, usually once daily. The dosage and length of||
3250|033|H|treatment are based on your medical condition and response to||
3250|034|H|treatment. Children's dosage is also based on age and weight.||
3250|035|H|   Handle the tablet with dry hands. Place the tablet on your||
3250|036|H|tongue and let it disintegrate. This takes less than 1 minute.||
3250|037|H|Swallow the remaining particles with or without water. Do not||
3250|038|H|crush, chew, or break the tablet or particles.||
3250|039|H|   If you have trouble swallowing the tablet, you may dissolve it||
3250|040|H|in water and take the mixture by mouth through an oral syringe.||
3250|041|H|Place a tablet in an oral syringe and draw up the correct amount||
3250|042|H|of water for your dose (4 milliliters for a 15-milligram tablet,||
3250|043|H|or 10 milliliters for a 30-milligram tablet) into the syringe.||
3250|044|H|Shake the syringe gently to break apart the tablet, then swallow||
3250|045|H|the liquid within 15 minutes. To make sure that you have taken||
3250|046|H|the entire dose, refill the syringe with water (2 milliliters for||
3250|047|H|the 15-milligram tablet, or 5 milliliters for the 30-milligram||
3250|048|H|tablet), shake again, and swallow all of the liquid. Do not||
3250|049|H|prepare the liquid mixture ahead of time for later use. Doing so||
3250|050|H|may destroy the drug.||
3250|051|H|   If you are giving this medication through a tube into the||
3250|052|H|stomach (nasogastric tube), ask your health care professional for||
3250|053|H|detailed instructions on how to properly mix and give it.||
3250|054|H|   If needed, antacids may be taken along with this medication.||
3250|055|H|If you are also taking sucralfate, take lansoprazole at least 30||
3250|056|H|minutes before sucralfate.||
3250|057|H|   Use this medication regularly to get the most benefit from it.||
3250|058|H|To help you remember, take it at the same time each day. Continue||
3250|059|H|to take this medication for the prescribed length of treatment||
3250|060|H|even if you are feeling better.||
3250|061|H|   Tell your doctor if your condition lasts or gets worse. The||
3250|062|H|risk of side effects goes up over time. Ask your doctor how long||
3250|063|H|you should take this medication.||
3250|064|B|||
3250|065|S|SIDE EFFECTS:  Diarrhea, abdominal pain, or headache may occur.||
3250|066|S|If any of these effects last or get worse, tell your doctor or||
3250|067|S|pharmacist promptly.||
3250|068|S|   Remember that this medication has been prescribed because your||
3250|069|S|doctor has judged that the benefit to you is greater than the||
3250|070|S|risk of side effects. Many people using this medication do not||
3250|071|S|have serious side effects.||
3250|072|S|   Tell your doctor right away if you have any serious side||
3250|073|S|effects, including: symptoms of a low magnesium blood level (such||
3250|074|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
3250|075|S|(such as rash on nose and cheeks, new or worsening joint pain),||
3250|076|S|signs of kidney problems (such as change in the amount of urine,||
3250|077|S|pink/bloody urine).||
3250|078|S|   This medication may rarely cause a severe intestinal condition||
3250|079|S|due to a bacteria called C. difficile. This condition may occur||
3250|080|S|during treatment or weeks to months after treatment has stopped.||
3250|081|S|Tell your doctor right away if you develop: diarrhea that doesn't||
3250|082|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
3250|083|S|stool.||
3250|084|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
3250|085|S|products because they may make symptoms worse.||
3250|086|S|   Rarely, proton pump inhibitors (such as lansoprazole) have||
3250|087|S|caused vitamin B-12 deficiency. The risk is increased if they are||
3250|088|S|taken every day for a long time (3 years or longer). Tell your||
3250|089|S|doctor right away if you develop symptoms of vitamin B-12||
3250|090|S|deficiency (such as unusual weakness, sore tongue, or||
3250|091|S|numbness/tingling of the hands/feet).||
3250|092|S|   A very serious allergic reaction to this drug is rare.||
3250|093|S|However, get medical help right away if you notice any symptoms||
3250|094|S|of a serious allergic reaction, including: fever, swollen lymph||
3250|095|S|nodes, rash, itching/swelling (especially of the||
3250|096|S|face/tongue/throat), severe dizziness, trouble breathing.||
3250|097|S|   This is not a complete list of possible side effects. If you||
3250|098|S|notice other effects not listed above, contact your doctor or||
3250|099|S|pharmacist.||
3250|100|S|   In the US -||
3250|101|S|   Call your doctor for medical advice about side effects. You||
3250|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3250|103|S|www.fda.gov/medwatch.||
3250|104|S|   In Canada - Call your doctor for medical advice about side||
3250|105|S|effects. You may report side effects to Health Canada at||
3250|106|S|1-866-234-2345.||
3250|107|B|||
3250|108|P|PRECAUTIONS:  Before taking lansoprazole, tell your doctor or||
3250|109|P|pharmacist if you are allergic to it; or to similar drugs (such||
3250|110|P|as dexlansoprazole, omeprazole, pantoprazole); or if you have any||
3250|111|P|other allergies. This product may contain inactive ingredients,||
3250|112|P|which can cause allergic reactions or other problems. Talk to||
3250|113|P|your pharmacist for more details.||
3250|114|P|   Before using this medication, tell your doctor or pharmacist||
3250|115|P|your medical history, especially of: liver disease, lupus.||
3250|116|P|   Some symptoms may actually be signs of a more serious||
3250|117|P|condition. Get medical help right away if you have: heartburn||
3250|118|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
3250|119|P|pain (especially with shortness of breath, unusual sweating),||
3250|120|P|unexplained weight loss.||
3250|121|P|   This medicine may contain aspartame. If you have||
3250|122|P|phenylketonuria (PKU) or any other condition that requires you to||
3250|123|P|restrict your intake of aspartame (or phenylalanine), ask your||
3250|124|P|doctor or pharmacist about using this drug safely.||
3250|125|P|   Before having surgery, tell your doctor or dentist about all||
3250|126|P|the products you use (including prescription drugs,||
3250|127|P|nonprescription drugs, and herbal products).||
3250|128|P|   Proton pump inhibitors (such as lansoprazole) may increase||
3250|129|P|your risk for bone fractures, especially with longer use, higher||
3250|130|P|doses, and in older adults. Talk with your doctor or pharmacist||
3250|131|P|about ways to prevent bone loss/fracture, such as by taking||
3250|132|P|calcium (such as calcium citrate) and vitamin D supplements.||
3250|133|P|   Older adults may be more sensitive to the side effects of this||
3250|134|P|drug, especially bone loss and fractures (see above), and C.||
3250|135|P|difficile infection (see Side Effects section).||
3250|136|P|   During pregnancy, this medication should be used only when||
3250|137|P|clearly needed. Discuss the risks and benefits with your doctor.||
3250|138|P|   It is unknown if this medication passes into breast milk.||
3250|139|P|However, similar drugs pass into breast milk. The effects on a||
3250|140|P|nursing infant are unknown. Consult your doctor before||
3250|141|P|breastfeeding.||
3250|142|B|||
3250|143|I|DRUG INTERACTIONS:  See also How to Use section.||
3250|144|I|   Drug interactions may change how your medications work or||
3250|145|I|increase your risk for serious side effects. This document does||
3250|146|I|not contain all possible drug interactions. Keep a list of all||
3250|147|I|the products you use (including prescription/nonprescription||
3250|148|I|drugs and herbal products) and share it with your doctor and||
3250|149|I|pharmacist. Do not start, stop, or change the dosage of any||
3250|150|I|medicines without your doctor's approval.||
3250|151|I|   A product that may interact with this drug is: methotrexate||
3250|152|I|(especially high-dose treatment).||
3250|153|I|   Some products need stomach acid so that the body can absorb||
3250|154|I|them properly. Lansoprazole decreases stomach acid, so it may||
3250|155|I|change how well these products work. Some affected products||
3250|156|I|include ampicillin, atazanavir, erlotinib, levoketoconazole,||
3250|157|I|nelfinavir, pazopanib, rilpivirine, sparsentan, certain azole||
3250|158|I|antifungals (itraconazole, ketoconazole, posaconazole), among||
3250|159|I|others.||
3250|160|I|   Lansoprazole is very similar to dexlansoprazole. Do not use||
3250|161|I|medications containing dexlansoprazole while using lansoprazole.||
3250|162|I|   This medication may interfere with certain lab tests, possibly||
3250|163|I|causing false test results. Make sure lab personnel and all your||
3250|164|I|doctors know you use this drug.||
3250|165|B|||
3250|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3250|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3250|168|O|poison control center right away. US residents can call||
3250|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3250|170|B|||
3250|171|N|NOTES:  Do not share this medication with others.||
3250|172|N|   If your doctor instructs you to use this medication regularly||
3250|173|N|for a long time, lab and/or medical tests (such as a magnesium||
3250|174|N|blood test, vitamin B-12 levels) may be done while you are taking||
3250|175|N|this medication. Keep all medical and lab appointments. Consult||
3250|176|N|your doctor for more details.||
3250|177|B|||
3250|178|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3250|179|D|remember. If it is near the time of the next dose, skip the||
3250|180|D|missed dose. Take your next dose at the regular time. Do not||
3250|181|D|double the dose to catch up.||
3250|182|B|||
3250|183|R|STORAGE:  Store at room temperature away from light and moisture.||
3250|184|R|Do not store in the bathroom. Keep all medications away from||
3250|185|R|children and pets.||
3250|186|R|   Do not flush medications down the toilet or pour them into a||
3250|187|R|drain unless instructed to do so. Properly discard this product||
3250|188|R|when it is expired or no longer needed. Consult your pharmacist||
3250|189|R|or local waste disposal company.||
3250|190|B|||
3250|191|A|Information last revised June 2024.||
3250|192|A|Copyright(c) 2025 First Databank, Inc.||
3250|193|B|||
3252|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3252|002|Z|does NOT have all possible information about this product. This||
3252|003|Z|information does not assure that this product is safe, effective,||
3252|004|Z|or appropriate for you. This information is not individual||
3252|005|Z|medical advice and does not substitute for the advice of your||
3252|006|Z|health care professional. Always ask your health care||
3252|007|Z|professional for complete information about this product and your||
3252|008|Z|specific health needs.||
3252|009|B|||
3252|010|T|LIDOCAINE/PRILOCAINE DISC - TOPICAL||
3252|011|F|(LYE-doe-kane/PRILL-oh-cane)||
3252|012|B|||
3252|013|C|COMMON BRAND NAME(S): Emla||
3252|014|B|||
3252|015|U|USES:  This medication is a patch that contains 2 amide-type||
3252|016|U|anesthetics for numbing a small area, lidocaine and prilocaine.||
3252|017|U|It is used on normal, unbroken skin to prevent pain before||
3252|018|U|certain procedures such as inserting a needle for injections or||
3252|019|U|drawing blood. It is also used before certain vaccinations||
3252|020|U|(measles/mumps/rubella-MMR,||
3252|021|U|diphtheria/pertussis/tetanus/poliovirus-DPTP, H. influenzae b,||
3252|022|U|hepatitis B). It works by temporarily numbing the skin and||
3252|023|U|surrounding area.||
3252|024|U|   This medication should not be used in premature infants||
3252|025|U|(infants born before 37 weeks of pregnancy).||
3252|026|B|||
3252|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3252|028|H|from your pharmacist before you start using lidocaine/prilocaine||
3252|029|H|disc and each time you get a refill. If you have any questions,||
3252|030|H|ask your doctor or pharmacist.||
3252|031|H|   Clean and dry the skin before applying the patch. Peel away||
3252|032|H|the protective liner and place the disc on the procedure site as||
3252|033|H|directed by your doctor, usually 1 hour before the procedure. Do||
3252|034|H|not touch the white round part that contains the medication.||
3252|035|H|Firmly press down on the edges of the patch to make sure it is||
3252|036|H|well attached. Gently press on the center of the patch. Using a||
3252|037|H|ballpoint pen, mark on the patch the time it was placed.||
3252|038|H|   Remove the patch and clean the area thoroughly, usually||
3252|039|H|shortly before the procedure or as directed by your doctor. The||
3252|040|H|length of time for the medication to stay on the skin depends on||
3252|041|H|your age and the type of procedure you are having. Do not leave||
3252|042|H|it in place for longer than directed since the chance for side||
3252|043|H|effects may be increased. Carefully fold the patch in half with||
3252|044|H|the sticky sides together and discard out of reach of children||
3252|045|H|and pets. Do not re-use the patch. Wash hands immediately after||
3252|046|H|use unless you are treating an area on the hands.||
3252|047|H|   This patch may be harmful if placed in the mouth or swallowed.||
3252|048|H|If you are applying this product on a child, make sure the patch||
3252|049|H|stays in place and that your child does not put the patch in||
3252|050|H|his/her mouth. You may want to use a second covering to prevent||
3252|051|H|the child from touching the patch.||
3252|052|H|   Use this medication only on normal, intact skin. Do not use on||
3252|053|H|open wounds/cuts/scrapes/burns/rashes (including diaper rash) or||
3252|054|H|mucous membranes. Do not use this product in the ears or near the||
3252|055|H|eyes. Avoid getting the product in your eyes, nose, ears, or||
3252|056|H|mouth. If this medication gets in the eyes, rinse the affected||
3252|057|H|eye right away and completely with water or saline. Numbness in||
3252|058|H|the eye can lead to injury because you cannot feel particles in||
3252|059|H|the eye or other dangers. Protect the eye until feeling returns.||
3252|060|H|   The numbing effect should start within 1 hour. The area may be||
3252|061|H|numb for several hours after removing the patch. Protect the area||
3252|062|H|from injury. Be careful not to bump, rub, or scratch the area or||
3252|063|H|expose it to heat/cold until feeling returns.||
3252|064|B|||
3252|065|S|SIDE EFFECTS:  Redness, swelling, tingling, burning, or||
3252|066|S|lightening of the skin may occur. If any of these effects last or||
3252|067|S|get worse, tell your doctor or pharmacist promptly.||
3252|068|S|   Remember that this medication has been prescribed because your||
3252|069|S|doctor has judged that the benefit to you is greater than the||
3252|070|S|risk of side effects. Many people using this medication do not||
3252|071|S|have serious side effects.||
3252|072|S|   Tell your doctor right away if you have any serious side||
3252|073|S|effects, including: blistering of the skin where the patch is||
3252|074|S|applied.||
3252|075|S|   Remove the patch and get medical help right away if you have||
3252|076|S|any very serious side effects, including: slow/shallow breathing,||
3252|077|S|dizziness, fainting, fast/slow/irregular heartbeat, mental/mood||
3252|078|S|changes (such as confusion, nervousness), seizure, severe||
3252|079|S|drowsiness, pale/bluish/gray skin, unusual tiredness, shortness||
3252|080|S|of breath.||
3252|081|S|   A very serious allergic reaction to this drug is rare.||
3252|082|S|However, get medical help right away if you notice any symptoms||
3252|083|S|of a serious allergic reaction, including: rash, itching/swelling||
3252|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3252|085|S|breathing.||
3252|086|S|   This is not a complete list of possible side effects. If you||
3252|087|S|notice other effects not listed above, contact your doctor or||
3252|088|S|pharmacist.||
3252|089|S|   In the US -||
3252|090|S|   Call your doctor for medical advice about side effects. You||
3252|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3252|092|S|www.fda.gov/medwatch.||
3252|093|S|   In Canada - Call your doctor for medical advice about side||
3252|094|S|effects. You may report side effects to Health Canada at||
3252|095|S|1-866-234-2345.||
3252|096|B|||
3252|097|P|PRECAUTIONS:  Before using this product, tell your doctor or||
3252|098|P|pharmacist if you are allergic to lidocaine or prilocaine; or to||
3252|099|P|any other amide anesthetics (such as bupivacaine); or if you have||
3252|100|P|any other allergies. This product may contain inactive||
3252|101|P|ingredients, which can cause allergic reactions or other||
3252|102|P|problems. Talk to your pharmacist for more details.||
3252|103|P|   Before using this medication, tell your doctor or pharmacist||
3252|104|P|your medical history, especially of: a certain blood disorder||
3252|105|P|(methemoglobinemia), heart disease (such as irregular heartbeat),||
3252|106|P|kidney disease, liver disease, skin problems (such as infection,||
3252|107|P|dermatitis, eczema).||
3252|108|P|   If you are going to have an MRI test, tell testing personnel||
3252|109|P|that you are using this patch. Some patches may contain metals||
3252|110|P|that can cause serious burns during an MRI. Ask your doctor||
3252|111|P|whether you will need to remove your patch before the test and||
3252|112|P|apply a new patch afterward, and how to do so properly.||
3252|113|P|   Older adults may be more sensitive to the side effects of this||
3252|114|P|drug, especially dizziness.||
3252|115|P|   During pregnancy, this medication should be used only when||
3252|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
3252|117|P|   Lidocaine passes into breast milk. It is unknown if prilocaine||
3252|118|P|passes into breast milk. Consult your doctor before||
3252|119|P|breastfeeding.||
3252|120|B|||
3252|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3252|122|I|medications work or increase your risk for serious side effects.||
3252|123|I|This document does not contain all possible drug interactions.||
3252|124|I|Keep a list of all the products you use (including||
3252|125|I|prescription/nonprescription drugs and herbal products) and share||
3252|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
3252|127|I|the dosage of any medicines without your doctor's approval.||
3252|128|B|||
3252|129|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3252|130|O|has overdosed and has serious symptoms such as passing out or||
3252|131|O|trouble breathing, call 911. Otherwise, call a poison control||
3252|132|O|center right away. US residents can call 1-800-222-1222. Canada||
3252|133|O|residents can call 1-844-764-7669. Symptoms of overdose may||
3252|134|O|include: seizures, loss of consciousness.||
3252|135|B|||
3252|136|N|NOTES:  Do not share this medication with others.||
3252|137|B|||
3252|138|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
3252|139|D|right away for a new dosing schedule.||
3252|140|B|||
3252|141|R|STORAGE:  Store at room temperature. Keep all medications away||
3252|142|R|from children and pets.||
3252|143|R|   Do not flush medications down the toilet or pour them into a||
3252|144|R|drain unless instructed to do so. Properly discard this product||
3252|145|R|when it is expired or no longer needed. Consult your pharmacist||
3252|146|R|or local waste disposal company.||
3252|147|B|||
3252|148|A|Information last revised May 2024.||
3252|149|A|Copyright(c) 2025 First Databank, Inc.||
3252|150|B|||
3253|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3253|002|Z|does NOT have all possible information about this product. This||
3253|003|Z|information does not assure that this product is safe, effective,||
3253|004|Z|or appropriate for you. This information is not individual||
3253|005|Z|medical advice and does not substitute for the advice of your||
3253|006|Z|health care professional. Always ask your health care||
3253|007|Z|professional for complete information about this product and your||
3253|008|Z|specific health needs.||
3253|009|B|||
3253|010|T|HYDROCORTISONE PROBUTATE - TOPICAL||
3253|011|F|(HYE-droe-KOR-ti-sone proe-BUE-tate)||
3253|012|B|||
3253|013|C|COMMON BRAND NAME(S): Pandel||
3253|014|B|||
3253|015|U|USES:  This medication is used to treat a variety of skin||
3253|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
3253|017|U|Hydrocortisone probutate reduces the swelling, itching, and||
3253|018|U|redness that can occur in these types of conditions. This||
3253|019|U|medication is a medium-strength corticosteroid. Do not use this||
3253|020|U|medication to treat diaper rash.||
3253|021|B|||
3253|022|H|HOW TO USE:  Use this medication on the skin only. However, do||
3253|023|H|not use it on the face, groin, or underarms unless directed to do||
3253|024|H|so by your doctor.||
3253|025|H|   Wash and dry your hands before using. Clean and dry the||
3253|026|H|affected area. Apply a thin film of medication to the affected||
3253|027|H|area and gently rub in as directed by your doctor, usually 1 to 2||
3253|028|H|times daily. Do not bandage, cover, or wrap the area unless||
3253|029|H|directed to do so by your doctor.||
3253|030|H|   After applying the medication, wash your hands. Avoid getting||
3253|031|H|this medication in the eyes, nose, or mouth. If you get the||
3253|032|H|medication in these areas, rinse with plenty of water.||
3253|033|H|   Use this medication only for the condition for which it was||
3253|034|H|prescribed. Do not use it for longer than prescribed.||
3253|035|H|   Tell your doctor if your condition lasts or gets worse after 2||
3253|036|H|weeks.||
3253|037|B|||
3253|038|S|SIDE EFFECTS:  Stinging, burning, irritation, dryness, numbness,||
3253|039|S|tingling, or redness at the application site may occur. Acne,||
3253|040|S|excessive hair growth, small red bumps on the skin||
3253|041|S|(folliculitis), skin thinning/discoloration, or stretch marks may||
3253|042|S|also occur. If any of these effects last or get worse, notify||
3253|043|S|your doctor or pharmacist promptly.||
3253|044|S|   Remember that this medication has been prescribed because your||
3253|045|S|doctor has judged that the benefit to you is greater than the||
3253|046|S|risk of side effects. Many people using this medication do not||
3253|047|S|have serious side effects.||
3253|048|S|   Rarely, it is possible this medication will be absorbed from||
3253|049|S|the skin into the bloodstream. This can lead to side effects of||
3253|050|S|too much corticosteroid. These side effects are more likely in||
3253|051|S|children, and in people who use this medication for a long time||
3253|052|S|or over large areas of the skin. Tell your doctor right away if||
3253|053|S|any of the following side effects occur: unusual/extreme||
3253|054|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
3253|055|S|thirst/urination, vision problems.||
3253|056|S|   A very serious allergic reaction to this drug is rare.||
3253|057|S|However, get medical help right away if you notice any symptoms||
3253|058|S|of a serious allergic reaction, including: rash, itching/swelling||
3253|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3253|060|S|breathing.||
3253|061|S|   This is not a complete list of possible side effects. If you||
3253|062|S|notice other effects not listed above, contact your doctor or||
3253|063|S|pharmacist.||
3253|064|S|   In the US -||
3253|065|S|   Call your doctor for medical advice about side effects. You||
3253|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3253|067|S|www.fda.gov/medwatch.||
3253|068|S|   In Canada - Call your doctor for medical advice about side||
3253|069|S|effects. You may report side effects to Health Canada at||
3253|070|S|1-866-234-2345.||
3253|071|B|||
3253|072|P|PRECAUTIONS:  Before using hydrocortisone probutate, tell your||
3253|073|P|doctor or pharmacist if you are allergic to it; or to other||
3253|074|P|corticosteroids (such as prednisone, triamcinolone); or if you||
3253|075|P|have any other allergies. This product may contain inactive||
3253|076|P|ingredients, which can cause allergic reactions or other||
3253|077|P|problems. Talk to your pharmacist for more details.||
3253|078|P|   Before using this medication, tell your doctor or pharmacist||
3253|079|P|your medical history.||
3253|080|P|   Do not use if there is an infection or sore in the area to be||
3253|081|P|treated. Skin infections can become worse when this medication is||
3253|082|P|used. Notify your doctor promptly if redness, swelling, or||
3253|083|P|irritation does not improve.||
3253|084|P|   Rarely, using corticosteroid medications for a long time or||
3253|085|P|over large areas of skin can make it more difficult for your body||
3253|086|P|to respond to physical stress. Before having surgery or emergency||
3253|087|P|treatment, or if you get a serious illness/injury, tell your||
3253|088|P|doctor or dentist that you are using this medication or have used||
3253|089|P|this medication within the past few months.||
3253|090|P|   Though it is unlikely, this medication may temporarily slow||
3253|091|P|down a child's growth if used for a long time. See the doctor||
3253|092|P|regularly so your child's height can be checked.||
3253|093|P|   During pregnancy, this medication should be used only when||
3253|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
3253|095|P|   It is unknown if this drug passes into breast milk when||
3253|096|P|applied to the skin. Similar medications pass into breast milk||
3253|097|P|when taken by mouth. Consult your doctor before breastfeeding.||
3253|098|B|||
3253|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3253|100|I|medications work or increase your risk for serious side effects.||
3253|101|I|This document does not contain all possible drug interactions.||
3253|102|I|Keep a list of all the products you use (including||
3253|103|I|prescription/nonprescription drugs and herbal products) and share||
3253|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
3253|105|I|the dosage of any medicines without your doctor's approval.||
3253|106|B|||
3253|107|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3253|108|O|has overdosed and has serious symptoms such as passing out or||
3253|109|O|trouble breathing, call 911. Otherwise, call a poison control||
3253|110|O|center right away. US residents can call 1-800-222-1222. Canada||
3253|111|O|residents can call 1-844-764-7669.||
3253|112|B|||
3253|113|N|NOTES:  Do not share this medication with others.||
3253|114|N|   This medication has been prescribed for your current condition||
3253|115|N|only. Do not use it later for other skin problems unless told to||
3253|116|N|do so by your doctor. A different medication may be necessary in||
3253|117|N|those cases.||
3253|118|N|   Lab and/or medical tests (such as adrenal gland function) may||
3253|119|N|be done while you are using this medication, especially if you||
3253|120|N|use this drug for an extended period of time or apply it over||
3253|121|N|large areas of the body. Keep all medical and lab appointments.||
3253|122|N|Consult your doctor for more details.||
3253|123|B|||
3253|124|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3253|125|D|If it is near the time of the next dose, skip the missed dose.||
3253|126|D|Use your next dose at the regular time. Do not double the dose to||
3253|127|D|catch up.||
3253|128|B|||
3253|129|R|STORAGE:  Store at room temperature. Keep all medications away||
3253|130|R|from children and pets.||
3253|131|R|   Do not flush medications down the toilet or pour them into a||
3253|132|R|drain unless instructed to do so. Properly discard this product||
3253|133|R|when it is expired or no longer needed. Consult your pharmacist||
3253|134|R|or local waste disposal company.||
3253|135|B|||
3253|136|A|Information last revised May 2024.||
3253|137|A|Copyright(c) 2025 First Databank, Inc.||
3253|138|B|||
3262|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3262|002|Z|does NOT have all possible information about this product. This||
3262|003|Z|information does not assure that this product is safe, effective,||
3262|004|Z|or appropriate for you. This information is not individual||
3262|005|Z|medical advice and does not substitute for the advice of your||
3262|006|Z|health care professional. Always ask your health care||
3262|007|Z|professional for complete information about this product and your||
3262|008|Z|specific health needs.||
3262|009|B|||
3262|010|T|CICLOPIROX LACQUER - TOPICAL||
3262|011|F|(cyc-low-PIE-rocks)||
3262|012|B|||
3262|013|C|COMMON BRAND NAME(S): Penlac||
3262|014|B|||
3262|015|U|USES:  This medication is used to treat fungal infections of the||
3262|016|U|fingernails and toenails. It is used as part of a treatment||
3262|017|U|program that may include the removal of unattached, infected||
3262|018|U|nails by a health care professional. Ciclopirox works by stopping||
3262|019|U|the growth of fungus.||
3262|020|B|||
3262|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3262|022|H|from your pharmacist before you start using ciclopirox and each||
3262|023|H|time you get a refill. If you have any questions, ask your doctor||
3262|024|H|or pharmacist.||
3262|025|H|   Before starting treatment, remove any loose nail material||
3262|026|H|using nail clippers or a file. If you have diabetes or numbness||
3262|027|H|in your fingers/toes, talk to your doctor before filing or||
3262|028|H|trimming your nails. It may be safer for your doctor to file or||
3262|029|H|remove your nails.||
3262|030|H|   Use this medication on the nails and skin next to the nails||
3262|031|H|only. Apply ciclopirox as directed by your doctor, usually once||
3262|032|H|daily at bedtime. Using the applicator provided, apply this||
3262|033|H|medication evenly over the entire affected nail and to the area||
3262|034|H|of the skin next to the nail (5 millimeters or 1/5 of an inch||
3262|035|H|around the nail). If the applicator can reach the undersurface of||
3262|036|H|the nail and the skin under the nail, apply the medication to||
3262|037|H|those areas as well. Avoid contact with skin that is not right||
3262|038|H|next to the affected nail. Do not use nail cosmetic products||
3262|039|H|(such as nail polish) on the treated nails.||
3262|040|H|   Do not apply the medication in the eyes, nose, or mouth, or||
3262|041|H|inside the vagina. If you do get the medication in those areas,||
3262|042|H|rinse with plenty of water.||
3262|043|H|   Let the medication dry (around 30 seconds) before putting on||
3262|044|H|socks or stockings. Do not wash the treated area for at least 8||
3262|045|H|hours.||
3262|046|H|   Every 7 days, remove the medication from the nail by applying||
3262|047|H|alcohol. Then trim the nail and file away any loose nail||
3262|048|H|material.||
3262|049|H|   This medication is flammable until dry. Avoid smoking or being||
3262|050|H|near open flames while using the medication and until the||
3262|051|H|medication has dried.||
3262|052|H|   Use this medication regularly in order to get the most benefit||
3262|053|H|from it. To help you remember, use it at the same time each day.||
3262|054|H|   Continue to use this medication for the full time prescribed,||
3262|055|H|even if symptoms disappear. Stopping the medication too early may||
3262|056|H|result in a return of the infection.||
3262|057|H|   Tell your doctor if your condition gets worse or if it does||
3262|058|H|not get better after 6 months of treatment. It may take up to one||
3262|059|H|year for the nail to be clear or almost clear.||
3262|060|B|||
3262|061|S|SIDE EFFECTS:  Redness/burning of treated skin or changes in||
3262|062|S|shape/color of nail may occur. If any of these effects last or||
3262|063|S|get worse, tell your doctor or pharmacist promptly.||
3262|064|S|   Remember that this medication has been prescribed because your||
3262|065|S|doctor has judged that the benefit to you is greater than the||
3262|066|S|risk of side effects. Many people using this medication do not||
3262|067|S|have serious side effects.||
3262|068|S|   Tell your doctor right away if you have any serious side||
3262|069|S|effects, including: blistering/swelling/oozing at the application||
3262|070|S|site.||
3262|071|S|   A very serious allergic reaction to this drug is rare.||
3262|072|S|However, get medical help right away if you notice any symptoms||
3262|073|S|of a serious allergic reaction, including: rash, itching/swelling||
3262|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3262|075|S|breathing.||
3262|076|S|   This is not a complete list of possible side effects. If you||
3262|077|S|notice other effects not listed above, contact your doctor or||
3262|078|S|pharmacist.||
3262|079|S|   In the US -||
3262|080|S|   Call your doctor for medical advice about side effects. You||
3262|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3262|082|S|www.fda.gov/medwatch.||
3262|083|S|   In Canada - Call your doctor for medical advice about side||
3262|084|S|effects. You may report side effects to Health Canada at||
3262|085|S|1-866-234-2345.||
3262|086|B|||
3262|087|P|PRECAUTIONS:  Before using ciclopirox, tell your doctor or||
3262|088|P|pharmacist if you are allergic to it; or if you have any other||
3262|089|P|allergies. This product may contain inactive ingredients, which||
3262|090|P|can cause allergic reactions or other problems. Talk to your||
3262|091|P|pharmacist for more details.||
3262|092|P|   Before using this medication, tell your doctor or pharmacist||
3262|093|P|your medical history, especially of: diabetes, numbness in||
3262|094|P|fingers/toes (such as diabetic neuropathy).||
3262|095|P|   Before having surgery, tell your doctors or dentist about all||
3262|096|P|the products you use (including prescription drugs,||
3262|097|P|nonprescription drugs, and herbal products).||
3262|098|P|   During pregnancy, this medication should be used only when||
3262|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
3262|100|P|   It is unknown if this medication passes into breast milk.||
3262|101|P|Consult your doctor before breastfeeding.||
3262|102|B|||
3262|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3262|104|I|medications work or increase your risk for serious side effects.||
3262|105|I|This document does not contain all possible drug interactions.||
3262|106|I|Keep a list of all the products you use (including||
3262|107|I|prescription/nonprescription drugs and herbal products) and share||
3262|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
3262|109|I|the dosage of any medicines without your doctor's approval.||
3262|110|B|||
3262|111|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3262|112|O|has overdosed and has serious symptoms such as passing out or||
3262|113|O|trouble breathing, call 911. Otherwise, call a poison control||
3262|114|O|center right away. US residents can call 1-800-222-1222. Canada||
3262|115|O|residents can call 1-844-764-7669.||
3262|116|B|||
3262|117|N|NOTES:  Do not share this medication with others.||
3262|118|N|   This medication has been prescribed for your current condition||
3262|119|N|only. Do not use it later for another infection unless your||
3262|120|N|doctor tells you to.||
3262|121|B|||
3262|122|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3262|123|D|If it is near the time of the next dose, skip the missed dose.||
3262|124|D|Use your next dose at the regular time. Do not double the dose to||
3262|125|D|catch up.||
3262|126|B|||
3262|127|R|STORAGE:  Store at room temperature away from light, heat, or||
3262|128|R|open flame. Keep the medication in the original carton to protect||
3262|129|R|from light. Keep all medications away from children and pets.||
3262|130|R|   Do not flush medications down the toilet or pour them into a||
3262|131|R|drain unless instructed to do so. Properly discard this product||
3262|132|R|when it is expired or no longer needed. Consult your pharmacist||
3262|133|R|or local waste disposal company.||
3262|134|B|||
3262|135|A|Information last revised July 2025.||
3262|136|A|Copyright(c) 2025 First Databank, Inc.||
3262|137|B|||
3268|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3268|002|Z|does NOT have all possible information about this product. This||
3268|003|Z|information does not assure that this product is safe, effective,||
3268|004|Z|or appropriate for you. This information is not individual||
3268|005|Z|medical advice and does not substitute for the advice of your||
3268|006|Z|health care professional. Always ask your health care||
3268|007|Z|professional for complete information about this product and your||
3268|008|Z|specific health needs.||
3268|009|B|||
3268|010|T|NELFINAVIR - ORAL||
3268|011|F|(nell-FIN-uh-veer)||
3268|012|B|||
3268|013|C|COMMON BRAND NAME(S): Viracept||
3268|014|B|||
3268|015|U|USES:  This drug is used with other HIV medications to help||
3268|016|U|control HIV infection. It helps to decrease the amount of HIV in||
3268|017|U|your body so your immune system can work better. This lowers your||
3268|018|U|chance of getting HIV complications (such as new infections,||
3268|019|U|cancer) and improves your quality of life. Nelfinavir belongs to||
3268|020|U|a class of drugs known as protease inhibitors.||
3268|021|U|   Nelfinavir is not a cure for HIV infection. To decrease your||
3268|022|U|risk of spreading HIV disease to others, continue to take all HIV||
3268|023|U|medications exactly as prescribed by your doctor. Use an||
3268|024|U|effective barrier method (latex or polyurethane condoms/dental||
3268|025|U|dams) during sexual activity as directed by your doctor. Do not||
3268|026|U|share personal items (such as needles/syringes, toothbrushes, and||
3268|027|U|razors) that may have contacted blood or other body fluids.||
3268|028|U|Consult your doctor or pharmacist for more details.||
3268|029|B|||
3268|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3268|031|H|from your pharmacist before you start using nelfinavir and each||
3268|032|H|time you get a refill. If you have any questions, ask your doctor||
3268|033|H|or pharmacist.||
3268|034|H|   Take this medication by mouth with a meal as directed by your||
3268|035|H|doctor, usually 2 to 3 times daily.||
3268|036|H|   If you are unable to swallow tablets, you may crush your dose||
3268|037|H|and take it with food. The tablets may also be dissolved in a||
3268|038|H|small amount of water. If dissolved in water, stir the mixture||
3268|039|H|well and drink all of it right away. Rinse your container with||
3268|040|H|more water and drink the rinse liquid to be sure you receive the||
3268|041|H|entire dose. Do not mix with acidic food or juices (such as||
3268|042|H|orange juice, apple juice/sauce) since this may make the medicine||
3268|043|H|taste bitter.||
3268|044|H|   The dosage is based on your weight, medical condition, other||
3268|045|H|medications, and response to treatment.||
3268|046|H|   For the best effect, take this medication at evenly spaced||
3268|047|H|times. To help you remember, take this medication at the same||
3268|048|H|times every day.||
3268|049|H|   It is very important to keep taking this medication (and other||
3268|050|H|HIV medications) exactly as prescribed by your doctor. Do not||
3268|051|H|take more or less of this drug than prescribed or stop taking it||
3268|052|H|(or other HIV medicines) even for a short time unless directed to||
3268|053|H|do so by your doctor. Skipping or changing your dose without||
3268|054|H|approval from your doctor may cause the amount of virus to||
3268|055|H|increase, make the infection more difficult to treat, or worsen||
3268|056|H|side effects.||
3268|057|B|||
3268|058|S|SIDE EFFECTS:  Diarrhea is a common side effect of this||
3268|059|S|medication. If you have diarrhea, ask your doctor or pharmacist||
3268|060|S|about ways to lessen this side effect, such as using||
3268|061|S|anti-diarrhea medicine. Nausea or gas may also occur. If any of||
3268|062|S|these effects last or get worse, tell your doctor or pharmacist||
3268|063|S|promptly.||
3268|064|S|   Remember that this medication has been prescribed because your||
3268|065|S|doctor has judged that the benefit to you is greater than the||
3268|066|S|risk of side effects. Many people using this medication do not||
3268|067|S|have serious side effects.||
3268|068|S|   As your immune system gets stronger, it can begin to fight off||
3268|069|S|infections you already had, possibly causing disease symptoms to||
3268|070|S|come back. You could also have symptoms if your immune system||
3268|071|S|becomes overactive. This reaction may happen at any time (soon||
3268|072|S|after starting HIV treatment or many months later). Tell your||
3268|073|S|doctor right away if you have any serious symptoms, including:||
3268|074|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
3268|075|S|that doesn't go away, headaches that are severe or don't go away,||
3268|076|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
3268|077|S|changes, signs of infection (such as sore throat that doesn't go||
3268|078|S|away, fever, chills, swollen lymph nodes, non-healing skin||
3268|079|S|sores), signs of an overactive thyroid (such as irritability,||
3268|080|S|nervousness, heat intolerance, fast/pounding/irregular heartbeat.||
3268|081|S|   Get medical help right away if you have any very serious side||
3268|082|S|effects, including: nausea/vomiting that doesn't stop, symptoms||
3268|083|S|of a heart attack (such as chest/jaw/left arm pain, shortness of||
3268|084|S|breath, unusual sweating), easy bruising/bleeding,||
3268|085|S|stomach/abdominal pain, dark urine, yellowing eyes/skin.||
3268|086|S|   This medication may rarely make your blood sugar rise, which||
3268|087|S|can cause or worsen diabetes. Tell your doctor right away if you||
3268|088|S|have symptoms of high blood sugar such as increased||
3268|089|S|thirst/urination. If you already have diabetes, check your blood||
3268|090|S|sugar regularly as directed and share the results with your||
3268|091|S|doctor. Your doctor may need to adjust your diabetes medication,||
3268|092|S|exercise program, or diet.||
3268|093|S|   Changes in body fat may occur while you are taking this||
3268|094|S|medication (such as increased fat in the upper back and stomach||
3268|095|S|areas, decreased fat in the arms and legs). The cause and||
3268|096|S|long-term effects of these changes are unknown. Discuss the risks||
3268|097|S|and benefits of treatment with your doctor, as well as the||
3268|098|S|possible use of exercise to reduce this side effect.||
3268|099|S|   A very serious allergic reaction to this drug is rare.||
3268|100|S|However, get medical help right away if you notice any symptoms||
3268|101|S|of a serious allergic reaction, including: rash, itching/swelling||
3268|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3268|103|S|breathing.||
3268|104|S|   This is not a complete list of possible side effects. If you||
3268|105|S|notice other effects not listed above, contact your doctor or||
3268|106|S|pharmacist.||
3268|107|S|   In the US -||
3268|108|S|   Call your doctor for medical advice about side effects. You||
3268|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3268|110|S|www.fda.gov/medwatch.||
3268|111|S|   In Canada - Call your doctor for medical advice about side||
3268|112|S|effects. You may report side effects to Health Canada at||
3268|113|S|1-866-234-2345.||
3268|114|B|||
3268|115|P|PRECAUTIONS:  Before taking nelfinavir, tell your doctor or||
3268|116|P|pharmacist if you are allergic to it; or if you have any other||
3268|117|P|allergies. This product may contain inactive ingredients, which||
3268|118|P|can cause allergic reactions or other problems. Talk to your||
3268|119|P|pharmacist for more details.||
3268|120|P|   Before using this medication, tell your doctor or pharmacist||
3268|121|P|your medical history, especially of: diabetes, heart problems||
3268|122|P|(coronary artery disease, heart attack), lipid problems (high||
3268|123|P|cholesterol or triglycerides/fats), hemophilia, liver problems.||
3268|124|P|   Before having surgery, tell your doctor or dentist about all||
3268|125|P|the products you use (including prescription drugs,||
3268|126|P|nonprescription drugs, and herbal products).||
3268|127|P|   Children may be more sensitive to the side effects of this||
3268|128|P|drug, especially diarrhea or rash.||
3268|129|P|   Tell your doctor if you are pregnant before using this||
3268|130|P|medication. Treatment can lower the risk of passing HIV infection||
3268|131|P|to your baby. Discuss the risks and benefits with your doctor.||
3268|132|P|   This medication passes into breast milk and may have||
3268|133|P|undesirable effects on a nursing infant. Breastfeeding is not||
3268|134|P|recommended while using this medication. Breast milk may also||
3268|135|P|transmit HIV. Consult your doctor before breastfeeding.||
3268|136|B|||
3268|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3268|138|I|medications work or increase your risk for serious side effects.||
3268|139|I|This document does not contain all possible drug interactions.||
3268|140|I|Keep a list of all the products you use (including||
3268|141|I|prescription/nonprescription drugs and herbal products) and share||
3268|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
3268|143|I|the dosage of any medicines without your doctor's approval.||
3268|144|I|   Some products that may interact with this drug include:||
3268|145|I|orlistat, certain drugs to lower acid in the stomach (proton pump||
3268|146|I|inhibitors such as lansoprazole, omeprazole).||
3268|147|I|   Nelfinavir can slow down the removal of other medications from||
3268|148|I|your body, which may affect how they work. Examples of affected||
3268|149|I|drugs include alfuzosin, certain antiarrhythmics (amiodarone,||
3268|150|I|quinidine), certain benzodiazepines (midazolam, triazolam),||
3268|151|I|domperidone, eletriptan, eplerenone, ergot alkaloids (such as||
3268|152|I|dihydroergotamine, ergonovine, ergotamine, methylergonovine),||
3268|153|I|isavuconazonium, lurasidone, naloxegol, pimozide, ranolazine,||
3268|154|I|regorafenib, tacrolimus, drugs to treat erectile dysfunction-ED||
3268|155|I|or pulmonary hypertension (such as sildenafil, vardenafil),||
3268|156|I|salmeterol, certain "statin" cholesterol drugs (lovastatin,||
3268|157|I|simvastatin), suvorexant, among others.||
3268|158|I|   Other medications can affect the removal of nelfinavir from||
3268|159|I|your body, which may affect how nelfinavir works. Examples||
3268|160|I|include apalutamide, certain anti-seizure drugs (carbamazepine,||
3268|161|I|phenobarbital, primidone), rifampin, St. John's wort, among||
3268|162|I|others.||
3268|163|I|   This medication may decrease the effectiveness of hormonal||
3268|164|I|birth control such as pills, patch, or ring. This could cause||
3268|165|I|pregnancy. Discuss with your doctor or pharmacist if you should||
3268|166|I|use reliable backup birth control methods while using this||
3268|167|I|medication. Also tell your doctor if you have any new spotting or||
3268|168|I|breakthrough bleeding, because these may be signs that your birth||
3268|169|I|control is not working well.||
3268|170|B|||
3268|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3268|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3268|173|O|poison control center right away. US residents can call||
3268|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3268|175|B|||
3268|176|N|NOTES:  Do not share this medication with others.||
3268|177|N|   Lab and/or medical tests (such as liver function, viral load,||
3268|178|N|T-cell counts, triglycerides/cholesterol, blood sugar) should be||
3268|179|N|done while you are taking this medication. Keep all medical and||
3268|180|N|lab appointments. Consult your doctor for more details.||
3268|181|B|||
3268|182|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3268|183|D|remember. If it is near the time of the next dose, skip the||
3268|184|D|missed dose. Take your next dose at the regular time. Do not||
3268|185|D|double the dose to catch up.||
3268|186|B|||
3268|187|R|STORAGE:  Store in the original container at room temperature||
3268|188|R|away from light and moisture. Do not store in the bathroom. Keep||
3268|189|R|all medications away from children and pets.||
3268|190|R|   Do not flush medications down the toilet or pour them into a||
3268|191|R|drain unless instructed to do so. Properly discard this product||
3268|192|R|when it is expired or no longer needed. Consult your pharmacist||
3268|193|R|or local waste disposal company.||
3268|194|B|||
3268|195|A|Information last revised April 2025.||
3268|196|A|Copyright(c) 2025 First Databank, Inc.||
3268|197|B|||
3269|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3269|002|Z|does NOT have all possible information about this product. This||
3269|003|Z|information does not assure that this product is safe, effective,||
3269|004|Z|or appropriate for you. This information is not individual||
3269|005|Z|medical advice and does not substitute for the advice of your||
3269|006|Z|health care professional. Always ask your health care||
3269|007|Z|professional for complete information about this product and your||
3269|008|Z|specific health needs.||
3269|009|B|||
3269|010|T|CEFDINIR SUSPENSION - ORAL||
3269|011|F|(SEFF-dih-neer)||
3269|012|B|||
3269|013|C|COMMON BRAND NAME(S): Omnicef||
3269|014|B|||
3269|015|U|USES:  Cefdinir is used to treat a wide variety of bacterial||
3269|016|U|infections. This medication is known as a cephalosporin||
3269|017|U|antibiotic. It works by stopping the growth of bacteria.||
3269|018|U|   This antibiotic treats only bacterial infections. It will not||
3269|019|U|work for viral infections (such as common cold, flu). Using any||
3269|020|U|antibiotic when it is not needed can cause it to not work for||
3269|021|U|future infections.||
3269|022|B|||
3269|023|H|HOW TO USE:  Take this medication by mouth with or without food||
3269|024|H|as directed by your doctor, usually once a day or twice a day||
3269|025|H|(every 12 hours). Shake the bottle well before each dose.||
3269|026|H|   The dosage is based on your medical condition and response to||
3269|027|H|treatment. Children's dosage is also based on weight.||
3269|028|H|   For the best effect, take this antibiotic at evenly spaced||
3269|029|H|times. To help you remember, take this medication at the same||
3269|030|H|time(s) every day.||
3269|031|H|   Continue to use this medication until the full prescribed||
3269|032|H|amount is finished, even if symptoms disappear after a few days.||
3269|033|H|Stopping the medication too early may result in a return of the||
3269|034|H|infection.||
3269|035|H|   Some medications can bind with cefdinir preventing its full||
3269|036|H|absorption. If you take antacids containing magnesium or||
3269|037|H|aluminum, iron supplements, or vitamin/mineral products, take||
3269|038|H|them at least 2 hours apart from cefdinir. However,||
3269|039|H|iron-fortified infant formulas do not bind with cefdinir and can||
3269|040|H|be given at the same time.||
3269|041|H|   Tell your doctor if your condition lasts or gets worse.||
3269|042|B|||
3269|043|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, headache, or diaper||
3269|044|S|rash in young children may occur. If any of these effects last or||
3269|045|S|get worse, notify your doctor or pharmacist promptly.||
3269|046|S|   This medication may cause your stools to turn a reddish color,||
3269|047|S|especially if you also take iron products. This is harmless.||
3269|048|S|   Remember that this medication has been prescribed because your||
3269|049|S|doctor has judged that the benefit to you is greater than the||
3269|050|S|risk of side effects. Many people using this medication do not||
3269|051|S|have serious side effects.||
3269|052|S|   Tell your doctor right away if you have any serious side||
3269|053|S|effects, including: signs of liver disease (such as||
3269|054|S|nausea/vomiting that doesn't stop, loss of appetite,||
3269|055|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), unusual||
3269|056|S|tiredness, new signs of infection (such as sore throat that||
3269|057|S|doesn't go away, fever, chills), easy bruising/bleeding, signs of||
3269|058|S|kidney problems (such as change in the amount of urine),||
3269|059|S|mental/mood changes (such as confusion).||
3269|060|S|   This medication may rarely cause a severe intestinal condition||
3269|061|S|due to a bacteria called C. difficile. This condition may occur||
3269|062|S|during treatment or weeks to months after treatment has stopped.||
3269|063|S|Tell your doctor right away if you develop: diarrhea that doesn't||
3269|064|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
3269|065|S|stool.||
3269|066|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
3269|067|S|products because they may make symptoms worse.||
3269|068|S|   Use of this medication for prolonged or repeated periods may||
3269|069|S|result in oral thrush or a new vaginal yeast infection (oral or||
3269|070|S|vaginal fungal infection). Contact your doctor if you notice||
3269|071|S|white patches in your mouth, a change in vaginal discharge or||
3269|072|S|other new symptoms.||
3269|073|S|   A very serious allergic reaction to this drug is rare.||
3269|074|S|However, get medical help right away if you notice any symptoms||
3269|075|S|of a serious allergic reaction, including: rash, itching/swelling||
3269|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3269|077|S|breathing.||
3269|078|S|   This is not a complete list of possible side effects. If you||
3269|079|S|notice other effects not listed above, contact your doctor or||
3269|080|S|pharmacist.||
3269|081|S|   In the US -||
3269|082|S|   Call your doctor for medical advice about side effects. You||
3269|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3269|084|S|www.fda.gov/medwatch.||
3269|085|S|   In Canada - Call your doctor for medical advice about side||
3269|086|S|effects. You may report side effects to Health Canada at||
3269|087|S|1-866-234-2345.||
3269|088|B|||
3269|089|P|PRECAUTIONS:  Before taking cefdinir, tell your doctor or||
3269|090|P|pharmacist if you are allergic to it; or to penicillins or other||
3269|091|P|cephalosporin antibiotics (such as cephalexin); or if you have||
3269|092|P|any other allergies. This product may contain inactive||
3269|093|P|ingredients, which can cause allergic reactions or other||
3269|094|P|problems. Talk to your pharmacist for more details.||
3269|095|P|   Before using this medication, tell your doctor or pharmacist||
3269|096|P|your medical history, especially of: kidney disease, intestinal||
3269|097|P|disease (colitis).||
3269|098|P|   This medicine contains sugar which may increase blood sugar||
3269|099|P|levels if you have diabetes. Consult your doctor or pharmacist||
3269|100|P|for more information.||
3269|101|P|   Cefdinir may cause live bacterial vaccines (such as typhoid||
3269|102|P|vaccine) to not work well. Tell your health care professional||
3269|103|P|that you are using cefdinir before having any||
3269|104|P|immunizations/vaccinations.||
3269|105|P|   Before having surgery, tell your doctor or dentist about all||
3269|106|P|the products you use (including prescription drugs,||
3269|107|P|nonprescription drugs, and herbal products).||
3269|108|P|   During pregnancy, this medication should be used only when||
3269|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
3269|110|P|   This drug does not pass into breast milk. Consult your doctor||
3269|111|P|before breastfeeding.||
3269|112|B|||
3269|113|I|DRUG INTERACTIONS:  See also How to Use section.||
3269|114|I|   Drug interactions may change how your medications work or||
3269|115|I|increase your risk for serious side effects. This document does||
3269|116|I|not contain all possible drug interactions. Keep a list of all||
3269|117|I|the products you use (including prescription/nonprescription||
3269|118|I|drugs and herbal products) and share it with your doctor and||
3269|119|I|pharmacist. Do not start, stop, or change the dosage of any||
3269|120|I|medicines without your doctor's approval.||
3269|121|I|   This medication may interfere with certain lab tests (such as||
3269|122|I|certain diabetic urine tests), possibly causing false test||
3269|123|I|results. Make sure lab personnel and all your doctors know you||
3269|124|I|use this drug.||
3269|125|B|||
3269|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3269|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3269|128|O|poison control center right away. US residents can call||
3269|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3269|130|O|Symptoms of overdose may include severe vomiting, seizures.||
3269|131|B|||
3269|132|N|NOTES:  Do not share this medication with others.||
3269|133|N|   This medication has been prescribed for your current condition||
3269|134|N|only. Do not use it later for another infection unless your||
3269|135|N|doctor tells you to.||
3269|136|N|   Lab and/or medical tests (such as kidney function) may be done||
3269|137|N|while you are taking this medication. Keep all medical and lab||
3269|138|N|appointments. Consult your doctor for more details.||
3269|139|B|||
3269|140|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3269|141|D|If it is near the time of the next dose, skip the missed dose.||
3269|142|D|Use your next dose at the regular time. Do not double the dose to||
3269|143|D|catch up.||
3269|144|B|||
3269|145|R|STORAGE:  Store at room temperature. Discard any unused portion||
3269|146|R|after 10 days. Keep all medications away from children and pets.||
3269|147|R|   Do not flush medications down the toilet or pour them into a||
3269|148|R|drain unless instructed to do so. Properly discard this product||
3269|149|R|when it is expired or no longer needed. Consult your pharmacist||
3269|150|R|or local waste disposal company.||
3269|151|B|||
3269|152|A|Information last revised May 2025.||
3269|153|A|Copyright(c) 2025 First Databank, Inc.||
3269|154|B|||
3271|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3271|002|Z|does NOT have all possible information about this product. This||
3271|003|Z|information does not assure that this product is safe, effective,||
3271|004|Z|or appropriate for you. This information is not individual||
3271|005|Z|medical advice and does not substitute for the advice of your||
3271|006|Z|health care professional. Always ask your health care||
3271|007|Z|professional for complete information about this product and your||
3271|008|Z|specific health needs.||
3271|009|B|||
3271|010|T|FONDAPARINUX - INJECTION||
3271|011|F|(FON-da-PAR-in-ux)||
3271|012|B|||
3271|013|C|COMMON BRAND NAME(S): Arixtra||
3271|014|B|||
3271|015|W|WARNING:  People using this medication may bleed near the spinal||
3271|016|W|cord after certain spinal procedures. Bleeding in this area can||
3271|017|W|cause paralysis that lasts a long time or could become permanent.||
3271|018|W|Talk with your doctor about the benefits and risks before any||
3271|019|W|spinal procedure. Your doctor may direct you to stop this||
3271|020|W|medication for a certain amount of time before and after the||
3271|021|W|procedure. Carefully follow your doctor's directions.||
3271|022|W|   The risk of bleeding may be higher if you have a deformed||
3271|023|W|spine, or have had spinal procedures/surgery before (such as||
3271|024|W|epidural catheter placement, difficult epidural/spinal puncture),||
3271|025|W|or are taking other drugs that can cause bleeding/bruising||
3271|026|W|(including antiplatelet drugs such as clopidogrel, "blood||
3271|027|W|thinners" such as warfarin/rivaroxaban, nonsteroidal||
3271|028|W|anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your||
3271|029|W|doctor right away if you notice symptoms such as back pain, leg||
3271|030|W|numbness/tingling/weakness, loss of control of the bowels or||
3271|031|W|bladder (incontinence).||
3271|032|B|||
3271|033|U|USES:  Fondaparinux is used to treat serious blood clots in the||
3271|034|U|legs and/or lungs. It is usually used with another "blood||
3271|035|U|thinner" medication (warfarin). If untreated, blood clots can||
3271|036|U|travel to the lungs, heart, or brain, causing serious (possibly||
3271|037|U|fatal) breathing problems, heart attack, or stroke. This drug may||
3271|038|U|also be used to prevent blood clots after certain surgeries with||
3271|039|U|an increased risk of blood clots (such as hip fracture,||
3271|040|U|abdominal, knee/hip replacement).||
3271|041|U|   Fondaparinux is known as a "blood thinner" (anticoagulant). It||
3271|042|U|is a drug similar to heparin that works by blocking certain||
3271|043|U|natural substances in the blood that cause clotting.||
3271|044|B|||
3271|045|V|OTHER USES:  This section contains uses of this drug that are not||
3271|046|V|listed in the approved professional labeling for the drug but||
3271|047|V|that may be prescribed by your health care professional. Use this||
3271|048|V|drug for a condition that is listed in this section only if it||
3271|049|V|has been so prescribed by your health care professional.||
3271|050|V|   This drug may also be used for certain types of heart attack||
3271|051|V|or a specific type of chest pain called unstable angina.||
3271|052|B|||
3271|053|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3271|054|H|from your pharmacist before you start using fondaparinux and each||
3271|055|H|time you get a refill. Ask your health care professional how to||
3271|056|H|prepare and use this medication. If you have any questions, ask||
3271|057|H|your doctor or pharmacist.||
3271|058|H|   Inject this medication under the skin as directed by your||
3271|059|H|doctor, usually once daily. The injection is given in the||
3271|060|H|stomach/abdomen. Do not inject into a muscle. The dosage and||
3271|061|H|length of treatment are based on your medical condition, weight,||
3271|062|H|and response to treatment.||
3271|063|H|   Before using, check this product for particles or||
3271|064|H|discoloration. If either is present, do not use the liquid. Do||
3271|065|H|not mix any other medication in the same injection. Before||
3271|066|H|injecting each dose, clean the skin you are going to inject into||
3271|067|H|(the injection site) with rubbing alcohol. Change the injection||
3271|068|H|site each time to lessen injury under the skin. To lessen||
3271|069|H|bruising, do not rub the injection site after a shot. Learn how||
3271|070|H|to store and discard medical supplies safely.||
3271|071|H|   When treating a blood clot, another "blood thinner" (warfarin)||
3271|072|H|is usually started within 3 days after you start using||
3271|073|H|fondaparinux. Your doctor will direct you to use both of these||
3271|074|H|medications until the warfarin is working well. Do not stop||
3271|075|H|either of these medications until your doctor directs you to||
3271|076|H|stop.||
3271|077|H|   To prevent blood clots due to surgery, your doctor may direct||
3271|078|H|you to start using this medication after surgery (such as 6 to 8||
3271|079|H|hours after knee/hip replacement surgery) and continue for||
3271|080|H|several days. Follow your doctor's directions closely. Starting||
3271|081|H|this medication too soon after surgery may increase the risk of||
3271|082|H|serious bleeding.||
3271|083|H|   This medication may also be given by injection into a vein by||
3271|084|H|a health care professional, as directed by your doctor.||
3271|085|H|   Use this medication regularly to get the most benefit from it.||
3271|086|H|To help you remember, use it at the same time each day.||
3271|087|B|||
3271|088|S|SIDE EFFECTS:  Pain, bruising, redness, and swelling at the||
3271|089|S|injection site may occur. Headache, nausea, vomiting, swelling of||
3271|090|S|the hands/feet, or fever may also occur. If any of these effects||
3271|091|S|last or get worse, tell your doctor or pharmacist promptly.||
3271|092|S|   Remember that this medication has been prescribed because your||
3271|093|S|doctor has judged that the benefit to you is greater than the||
3271|094|S|risk of side effects. Many people using this medication do not||
3271|095|S|have serious side effects.||
3271|096|S|   Tell your doctor right away if you have any serious side||
3271|097|S|effects, including: easy bleeding/bruising, dark urine, yellow||
3271|098|S|eyes/skin.||
3271|099|S|   This medication may rarely cause serious bleeding. (See also||
3271|100|S|Warning section.) Tell your doctor right away if you have any||
3271|101|S|signs of serious bleeding, including: shortness of breath,||
3271|102|S|coughing up blood, chest pain, cold/blue fingers or toes, unusual||
3271|103|S|dizziness, fainting, fast/irregular heartbeat, joint/muscle pain,||
3271|104|S|mental/mood changes (such as confusion), numbness/tingling,||
3271|105|S|severe stomach/abdominal pain, bloody/black/tarry stools,||
3271|106|S|red/pinkish urine, vomit that looks like coffee grounds.||
3271|107|S|   Get medical help right away if you have any very serious side||
3271|108|S|effects, including: headache that is severe or doesn't go away,||
3271|109|S|vision problems, weakness on one side of the body, trouble||
3271|110|S|speaking, seizures, difficulty moving.||
3271|111|S|   A very serious allergic reaction to this drug is rare.||
3271|112|S|However, get medical help right away if you notice any symptoms||
3271|113|S|of a serious allergic reaction, including: rash, itching/swelling||
3271|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3271|115|S|breathing.||
3271|116|S|   This is not a complete list of possible side effects. If you||
3271|117|S|notice other effects not listed above, contact your doctor or||
3271|118|S|pharmacist.||
3271|119|S|   In the US -||
3271|120|S|   Call your doctor for medical advice about side effects. You||
3271|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3271|122|S|www.fda.gov/medwatch.||
3271|123|S|   In Canada - Call your doctor for medical advice about side||
3271|124|S|effects. You may report side effects to Health Canada at||
3271|125|S|1-866-234-2345.||
3271|126|B|||
3271|127|P|PRECAUTIONS:  See also Warning section.||
3271|128|P|   Before using fondaparinux, tell your doctor or pharmacist if||
3271|129|P|you are allergic to it; or if you have any other allergies. This||
3271|130|P|product may contain inactive ingredients (such as dry natural||
3271|131|P|rubber/latex in the needle cover on the prefilled syringe), which||
3271|132|P|can cause allergic reactions or other problems. Talk to your||
3271|133|P|pharmacist for more details.||
3271|134|P|   Before using fondaparinux, tell your doctor or pharmacist your||
3271|135|P|medical history, especially of: infection in the heart (bacterial||
3271|136|P|endocarditis), current serious bleeding (such as bleeding ulcer),||
3271|137|P|low platelet count because of antiplatelet antibody,||
3271|138|P|bleeding/blood problems (such as low blood count/platelets), a||
3271|139|P|past blood-clotting problem because of heparin (heparin-induced||
3271|140|P|thrombocytopenia), a certain eye problem (diabetic retinopathy),||
3271|141|P|high blood pressure, kidney disease, seizures, stomach/intestinal||
3271|142|P|problems (such as recent ulcers, colitis), stroke, recent spinal||
3271|143|P|procedures or puncture, spine problems (such as spinal||
3271|144|P|deformity), recent surgery (especially on the eye, brain, or||
3271|145|P|spine), low body weight (less than 50 kilograms/110 pounds).||
3271|146|P|   Before having surgery, tell your doctor or dentist about all||
3271|147|P|the products you use (including prescription drugs,||
3271|148|P|nonprescription drugs, and herbal products).||
3271|149|P|   Limit alcohol while taking this drug because it may increase||
3271|150|P|the risk of stomach bleeding.||
3271|151|P|   To lower the chance of getting cut, bruised, or injured, use||
3271|152|P|caution with sharp objects like razors and nail cutters, and||
3271|153|P|avoid activities such as contact sports.||
3271|154|P|   Older adults may be more sensitive to the side effects of this||
3271|155|P|drug, especially bleeding.||
3271|156|P|   During pregnancy, this medication should be used only when||
3271|157|P|clearly needed. Discuss the risks and benefits with your doctor.||
3271|158|P|If you become pregnant or think you may be pregnant, tell your||
3271|159|P|doctor right away.||
3271|160|P|   It is unknown if this drug passes into breast milk. Consult||
3271|161|P|your doctor before breastfeeding.||
3271|162|B|||
3271|163|I|DRUG INTERACTIONS:  See also Warning section.||
3271|164|I|   Drug interactions may change how your medications work or||
3271|165|I|increase your risk for serious side effects. This document does||
3271|166|I|not contain all possible drug interactions. Keep a list of all||
3271|167|I|the products you use (including prescription/nonprescription||
3271|168|I|drugs and herbal products) and share it with your doctor and||
3271|169|I|pharmacist. Do not start, stop, or change the dosage of any||
3271|170|I|medicines without your doctor's approval.||
3271|171|I|   Some products that may interact with this drug include:||
3271|172|I|mifepristone, other drugs that can cause bleeding/bruising||
3271|173|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
3271|174|I|ketorolac, "blood thinners" such as rivaroxaban).||
3271|175|I|   Check all prescription and nonprescription medicine labels||
3271|176|I|carefully since many medications contain pain relievers/fever||
3271|177|I|reducers (NSAIDs such as ibuprofen, naproxen, aspirin) which can||
3271|178|I|increase the risk of bleeding when used with fondaparinux.||
3271|179|I|However, if your doctor has told you to take low-dose aspirin to||
3271|180|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
3271|181|I|you should keep taking the aspirin unless your doctor tells you||
3271|182|I|not to. Ask your doctor or pharmacist for more details.||
3271|183|B|||
3271|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3271|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3271|186|O|poison control center right away. US residents can call||
3271|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3271|188|O|Symptoms of overdose may include: excessive bleeding and||
3271|189|O|bruising.||
3271|190|B|||
3271|191|N|NOTES:  Do not share this medication with others.||
3271|192|N|   Lab and/or medical tests (such as complete blood count, kidney||
3271|193|N|function) should be done while you are using this medication.||
3271|194|N|Keep all medical and lab appointments. Consult your doctor for||
3271|195|N|more details.||
3271|196|B|||
3271|197|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3271|198|D|If it is near the time of the next dose, skip the missed dose.||
3271|199|D|Use your next dose at the regular time. Do not double the dose to||
3271|200|D|catch up.||
3271|201|B|||
3271|202|R|STORAGE:  Store at room temperature. Discard any unused portion||
3271|203|R|after use. Keep all medications away from children and pets.||
3271|204|R|   Do not flush medications down the toilet or pour them into a||
3271|205|R|drain unless instructed to do so. Properly discard this product||
3271|206|R|when it is expired or no longer needed. Consult your pharmacist||
3271|207|R|or local waste disposal company.||
3271|208|B|||
3271|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
3271|210|M|medical emergency. For information about enrolling in MedicAlert,||
3271|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3271|212|B|||
3271|213|A|Information last revised December 2024.||
3271|214|A|Copyright(c) 2025 First Databank, Inc.||
3271|215|B|||
3273|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3273|002|Z|does NOT have all possible information about this product. This||
3273|003|Z|information does not assure that this product is safe, effective,||
3273|004|Z|or appropriate for you. This information is not individual||
3273|005|Z|medical advice and does not substitute for the advice of your||
3273|006|Z|health care professional. Always ask your health care||
3273|007|Z|professional for complete information about this product and your||
3273|008|Z|specific health needs.||
3273|009|B|||
3273|010|T|NILUTAMIDE - ORAL||
3273|011|F|(nye-LOO-tuh-mide)||
3273|012|B|||
3273|013|C|COMMON BRAND NAME(S): Nilandron||
3273|014|B|||
3273|015|W|WARNING:  Rarely, nilutamide has caused severe (sometimes fatal)||
3273|016|W|lung problems (interstitial pneumonitis). Get medical help right||
3273|017|W|away if you develop symptoms of lung problems (such as cough,||
3273|018|W|trouble breathing, chest pain, fever). Lung problems can happen||
3273|019|W|at any time while you are taking nilutamide, but they occur most||
3273|020|W|often during the first 3 months of treatment. Your doctor will||
3273|021|W|tell you whether to stop or continue nilutamide.||
3273|022|W|   Your doctor may have you get a chest X-ray and breathing tests||
3273|023|W|before you start nilutamide.||
3273|024|B|||
3273|025|U|USES:  This medication is used to treat prostate cancer.||
3273|026|U|Nilutamide belongs to a class of drugs known as anti-androgens||
3273|027|U|(anti-testosterone). Testosterone, a natural hormone, helps||
3273|028|U|prostate cancer to grow and spread. Nilutamide works by blocking||
3273|029|U|the effects of testosterone, thereby slowing the growth and||
3273|030|U|spread of prostate cancer.||
3273|031|B|||
3273|032|H|HOW TO USE:  Take this medication by mouth with or without food||
3273|033|H|as directed by your doctor, usually once daily. If you are taking||
3273|034|H|nilutamide after surgery, it is usually started on the day of||
3273|035|H|surgery or the day after. After 30 days of treatment, your doctor||
3273|036|H|will usually decrease your dose.||
3273|037|H|   The dosage is based on your medical condition and response to||
3273|038|H|treatment. The length of treatment depends on how your body and||
3273|039|H|the cancer respond to nilutamide and other treatments.||
3273|040|H|   Use this medication regularly to get the most benefit from it.||
3273|041|H|To help you remember, take it at the same time each day. Do not||
3273|042|H|stop any medications for your prostate cancer unless told to do||
3273|043|H|so by your doctor. Stopping your medications could allow the||
3273|044|H|cancer to spread more rapidly.||
3273|045|H|   Since this drug can be absorbed through the skin and lungs and||
3273|046|H|may harm an unborn baby, women who are pregnant or who may become||
3273|047|H|pregnant should not handle this medication or breathe the dust||
3273|048|H|from the tablets.||
3273|049|H|   Tell your doctor if your condition lasts or gets worse (such||
3273|050|H|as urination becomes more difficult, bone pain increases).||
3273|051|B|||
3273|052|S|SIDE EFFECTS:  See also Warning section.||
3273|053|S|   Because nilutamide may be used with other medications, the||
3273|054|S|side effects may be due to any one medicine or the combination of||
3273|055|S|medications. Hot flashes, sweating, dizziness, loss of sexual||
3273|056|S|interest/ability, vision changes (such as difficulty seeing when||
3273|057|S|moving into the dark or light, changes in color vision), stomach||
3273|058|S|pain, constipation, nausea, signs of alcohol intolerance (such as||
3273|059|S|flushing, tiredness) dry skin, increased sensitivity to||
3273|060|S|touch/pain, and loss of body hair may occur. If any of these||
3273|061|S|effects last or get worse, tell your doctor or pharmacist||
3273|062|S|promptly.||
3273|063|S|   Remember that this medication has been prescribed because your||
3273|064|S|doctor has judged that the benefit to you is greater than the||
3273|065|S|risk of side effects. Many people using this medication do not||
3273|066|S|have serious side effects.||
3273|067|S|   Rarely, nilutamide has caused severe (sometimes fatal) liver||
3273|068|S|problems. Get medical help right away if you develop symptoms of||
3273|069|S|liver problems (such as nausea/vomiting that doesn't stop, loss||
3273|070|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
3273|071|S|urine). Liver problems can happen at any time while taking||
3273|072|S|nilutamide, but they occur most often during the first 3-4 months||
3273|073|S|of treatment. Your doctor will tell you whether to stop or||
3273|074|S|continue nilutamide. Your doctor will monitor your liver function||
3273|075|S|with blood tests before you start and while you are taking||
3273|076|S|nilutamide. Keep all medical and lab appointments.||
3273|077|S|   A very serious allergic reaction to this drug is rare.||
3273|078|S|However, get medical help right away if you notice any symptoms||
3273|079|S|of a serious allergic reaction, including: rash, itching/swelling||
3273|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3273|081|S|breathing.||
3273|082|S|   This is not a complete list of possible side effects. If you||
3273|083|S|notice other effects not listed above, contact your doctor or||
3273|084|S|pharmacist.||
3273|085|S|   In the US -||
3273|086|S|   Call your doctor for medical advice about side effects. You||
3273|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3273|088|S|www.fda.gov/medwatch.||
3273|089|S|   In Canada - Call your doctor for medical advice about side||
3273|090|S|effects. You may report side effects to Health Canada at||
3273|091|S|1-866-234-2345.||
3273|092|B|||
3273|093|P|PRECAUTIONS:  Before taking nilutamide, tell your doctor or||
3273|094|P|pharmacist if you are allergic to it; or if you have any other||
3273|095|P|allergies. This product may contain inactive ingredients, which||
3273|096|P|can cause allergic reactions or other problems. Talk to your||
3273|097|P|pharmacist for more details.||
3273|098|P|   Before using this medication, tell your doctor or pharmacist||
3273|099|P|your medical history, especially of: lung disease (such as||
3273|100|P|asthma, chronic obstructive pulmonary disease-COPD, emphysema),||
3273|101|P|liver problems.||
3273|102|P|   This drug may rarely make you dizzy or drowsy or cause vision||
3273|103|P|changes. Alcohol or marijuana (cannabis) can make you more dizzy||
3273|104|P|or drowsy. Do not drive, use machinery, or do anything that needs||
3273|105|P|alertness or clear vision until you can do it safely. You may||
3273|106|P|also develop intolerance to alcohol while taking this medication.||
3273|107|P|Avoid alcoholic beverages. Talk to your doctor if you are using||
3273|108|P|marijuana (cannabis).||
3273|109|P|   Before having surgery, tell your doctor or dentist about all||
3273|110|P|the products you use (including prescription drugs,||
3273|111|P|nonprescription drugs, and herbal products).||
3273|112|P|   Nilutamide should not be used by women, especially during||
3273|113|P|pregnancy or breastfeeding. It may harm an unborn or||
3273|114|P|breastfeeding baby. Consult your doctor for more details.||
3273|115|B|||
3273|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3273|117|I|medications work or increase your risk for serious side effects.||
3273|118|I|This document does not contain all possible drug interactions.||
3273|119|I|Keep a list of all the products you use (including||
3273|120|I|prescription/nonprescription drugs and herbal products) and share||
3273|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
3273|122|I|the dosage of any medicines without your doctor's approval.||
3273|123|I|   Some of the products that may interact with this drug include:||
3273|124|I|testosterone (patch, gel, injection), anabolic steroids||
3273|125|I|(including over-the-counter androgens/anabolics/testosterone||
3273|126|I|precursors), DHEA, phenytoin, warfarin.||
3273|127|B|||
3273|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3273|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3273|130|O|poison control center right away. US residents can call||
3273|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3273|132|B|||
3273|133|N|NOTES:  Do not share this medication with others.||
3273|134|N|   Lab and/or medical tests (such as liver function, blood PSA||
3273|135|N|test) should be done before you start taking this medication and||
3273|136|N|while you are taking it. Keep all medical and lab appointments.||
3273|137|N|Consult your doctor for more details. (See also Warning section.)||
3273|138|B|||
3273|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3273|140|D|remember. If it is near the time of the next dose, skip the||
3273|141|D|missed dose. Take your next dose at the regular time. Do not||
3273|142|D|double the dose to catch up.||
3273|143|B|||
3273|144|R|STORAGE:  Store at room temperature away from light and moisture.||
3273|145|R|Do not store in the bathroom. Keep all medications away from||
3273|146|R|children and pets.||
3273|147|R|   Do not flush medications down the toilet or pour them into a||
3273|148|R|drain unless instructed to do so. Properly discard this product||
3273|149|R|when it is expired or no longer needed. Consult your pharmacist||
3273|150|R|or local waste disposal company.||
3273|151|B|||
3273|152|A|Information last revised May 2024.||
3273|153|A|Copyright(c) 2025 First Databank, Inc.||
3273|154|B|||
3274|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3274|002|Z|does NOT have all possible information about this product. This||
3274|003|Z|information does not assure that this product is safe, effective,||
3274|004|Z|or appropriate for you. This information is not individual||
3274|005|Z|medical advice and does not substitute for the advice of your||
3274|006|Z|health care professional. Always ask your health care||
3274|007|Z|professional for complete information about this product and your||
3274|008|Z|specific health needs.||
3274|009|B|||
3274|010|T|RISPERIDONE DISINTEGRATING TABLET - ORAL||
3274|011|F|(riss-PAIR-ih-doan)||
3274|012|B|||
3274|013|C|COMMON BRAND NAME(S): Risperdal M||
3274|014|B|||
3274|015|W|WARNING:  There may be a slightly increased risk of serious,||
3274|016|W|possibly fatal side effects (such as stroke, heart failure,||
3274|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
3274|018|W|by older adults with dementia. This medication is not approved||
3274|019|W|for the treatment of dementia-related behavior problems. Discuss||
3274|020|W|the risks and benefits of this medication, as well as other||
3274|021|W|effective and possibly safer treatments for dementia-related||
3274|022|W|behavior problems, with the doctor.||
3274|023|W|   If you are using risperidone in combination with other||
3274|024|W|medication to treat depression, also carefully read the drug||
3274|025|W|information for the other medication.||
3274|026|B|||
3274|027|U|USES:  This medication is used to treat certain mental/mood||
3274|028|U|disorders (such as schizophrenia, bipolar disorder, irritability||
3274|029|U|associated with autistic disorder). Risperidone belongs to a||
3274|030|U|class of drugs known as atypical antipsychotics. It works by||
3274|031|U|helping to restore the balance of certain natural substances in||
3274|032|U|the brain.||
3274|033|B|||
3274|034|V|OTHER USES:  This section contains uses of this drug that are not||
3274|035|V|listed in the approved professional labeling for the drug but||
3274|036|V|that may be prescribed by your health care professional. Use this||
3274|037|V|drug for a condition that is listed in this section only if it||
3274|038|V|has been so prescribed by your health care professional.||
3274|039|V|   This medication may also be used for other mental/mood||
3274|040|V|disorders (such as obsessive-compulsive disorder, depression).||
3274|041|B|||
3274|042|H|HOW TO USE:  Take this medication by mouth with or without food||
3274|043|H|as directed by your doctor, usually once or twice daily.||
3274|044|H|   This medication comes in a blister pack. Do not remove the||
3274|045|H|tablet from the packaging until you are ready to take it. With||
3274|046|H|dry hands, peel back the foil on the blister pack to carefully||
3274|047|H|remove the tablet. Do not try to push the tablet through the foil||
3274|048|H|because doing so can damage the tablet. Place the tablet on your||
3274|049|H|tongue right away and allow it to dissolve on your tongue. Do not||
3274|050|H|split or chew the tablet. After the tablet has melted on the||
3274|051|H|tongue, it can be swallowed with or without water.||
3274|052|H|   The dosage is based on your age, medical condition, response||
3274|053|H|to treatment, and other medications you may be taking. Be sure to||
3274|054|H|tell your doctor and pharmacist about all the products you use||
3274|055|H|(including prescription drugs, nonprescription drugs, and herbal||
3274|056|H|products). To reduce your risk of side effects, your doctor may||
3274|057|H|direct you to start this medication at a low dose and gradually||
3274|058|H|increase your dose. Follow your doctor's instructions carefully.||
3274|059|H|   Take this medication regularly to get the most benefit from||
3274|060|H|it. To help you remember, take it at the same time(s) each day.||
3274|061|H|Keep taking this medication even if you feel well. Do not stop||
3274|062|H|taking this medication without consulting your doctor.||
3274|063|H|   Tell your doctor if your condition lasts or gets worse.||
3274|064|B|||
3274|065|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, drooling,||
3274|066|S|nausea, weight gain, or tiredness may occur. If any of these||
3274|067|S|effects last or get worse, tell your doctor or pharmacist||
3274|068|S|promptly.||
3274|069|S|   Dizziness and lightheadedness can increase the risk of||
3274|070|S|falling. Get up slowly when rising from a sitting or lying||
3274|071|S|position.||
3274|072|S|   Remember that this medication has been prescribed because your||
3274|073|S|doctor has judged that the benefit to you is greater than the||
3274|074|S|risk of side effects. Many people using this medication do not||
3274|075|S|have serious side effects.||
3274|076|S|   Tell your doctor right away if you have any serious side||
3274|077|S|effects, including: difficulty swallowing, muscle spasms, shaking||
3274|078|S|(tremor), mental/mood changes (such as anxiety, restlessness),||
3274|079|S|interrupted breathing during sleep.||
3274|080|S|   This medication may rarely make your blood sugar rise, which||
3274|081|S|can cause or worsen diabetes. Tell your doctor right away if you||
3274|082|S|have symptoms of high blood sugar such as increased||
3274|083|S|thirst/urination. If you already have diabetes, check your blood||
3274|084|S|sugar regularly as directed and share the results with your||
3274|085|S|doctor. Your doctor may need to adjust your diabetes medication,||
3274|086|S|exercise program, or diet.||
3274|087|S|   This drug may also cause significant weight gain and a rise in||
3274|088|S|your blood cholesterol (or triglyceride) levels. These effects,||
3274|089|S|along with diabetes, may increase your risk for developing heart||
3274|090|S|disease. Discuss the risks and benefits of treatment with your||
3274|091|S|doctor. (See also Notes section.)||
3274|092|S|   Risperidone may rarely cause a condition known as tardive||
3274|093|S|dyskinesia. In some cases, this condition may be permanent. Tell||
3274|094|S|your doctor right away if you develop any unusual/uncontrolled||
3274|095|S|movements (especially of the face, lips, mouth, tongue, arms or||
3274|096|S|legs).||
3274|097|S|   This medication may increase a certain natural substance||
3274|098|S|(prolactin) made by your body. For females, this increase in||
3274|099|S|prolactin may result in unwanted breast milk, missed/stopped||
3274|100|S|periods, or difficulty becoming pregnant. For males, it may||
3274|101|S|result in decreased sexual ability, inability to produce sperm,||
3274|102|S|or enlarged breasts. If you develop any of these symptoms, tell||
3274|103|S|your doctor right away.||
3274|104|S|   Get medical help right away if you have any very serious side||
3274|105|S|effects, including: severe dizziness, fainting, seizures.||
3274|106|S|   This medication may rarely cause a very serious condition||
3274|107|S|called neuroleptic malignant syndrome (NMS). Get medical help||
3274|108|S|right away if you have any of the following symptoms: fever,||
3274|109|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
3274|110|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
3274|111|S|signs of kidney problems (such as change in the amount of urine).||
3274|112|S|   Rarely, males may have a painful or prolonged erection lasting||
3274|113|S|4 or more hours. If this occurs, stop using this drug and get||
3274|114|S|medical help right away, or permanent problems could occur.||
3274|115|S|   A very serious allergic reaction to this drug is rare.||
3274|116|S|However, get medical help right away if you notice any symptoms||
3274|117|S|of a serious allergic reaction, including: fever, swollen lymph||
3274|118|S|nodes, rash, itching/swelling (especially of the||
3274|119|S|face/tongue/throat), severe dizziness, trouble breathing.||
3274|120|S|   This is not a complete list of possible side effects. If you||
3274|121|S|notice other effects not listed above, contact your doctor or||
3274|122|S|pharmacist.||
3274|123|S|   In the US -||
3274|124|S|   Call your doctor for medical advice about side effects. You||
3274|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3274|126|S|www.fda.gov/medwatch.||
3274|127|S|   In Canada - Call your doctor for medical advice about side||
3274|128|S|effects. You may report side effects to Health Canada at||
3274|129|S|1-866-234-2345.||
3274|130|B|||
3274|131|P|PRECAUTIONS:  Before taking risperidone, tell your doctor or||
3274|132|P|pharmacist if you are allergic to it; or to paliperidone; or if||
3274|133|P|you have any other allergies. This product may contain inactive||
3274|134|P|ingredients, which can cause allergic reactions or other||
3274|135|P|problems. Talk to your pharmacist for more details.||
3274|136|P|   Before using this medication, tell your doctor or pharmacist||
3274|137|P|your medical history, especially of: liver disease, kidney||
3274|138|P|disease, seizures, difficulty swallowing, low white blood cell||
3274|139|P|count, Parkinson's disease, dementia, certain eye problems||
3274|140|P|(cataracts, glaucoma), personal or family history of diabetes,||
3274|141|P|heart disease, high cholesterol/triglyceride levels, breathing||
3274|142|P|trouble during sleep (sleep apnea).||
3274|143|P|   Risperidone may cause a condition that affects the heart||
3274|144|P|rhythm (QT prolongation). QT prolongation can rarely cause||
3274|145|P|serious (rarely fatal) fast/irregular heartbeat and other||
3274|146|P|symptoms (such as severe dizziness, fainting) that need medical||
3274|147|P|attention right away.||
3274|148|P|   The risk of QT prolongation may be increased if you have||
3274|149|P|certain medical conditions or are taking other drugs that may||
3274|150|P|cause QT prolongation. Before using risperidone, tell your doctor||
3274|151|P|or pharmacist of all the drugs you take and if you have any of||
3274|152|P|the following conditions: certain heart problems (heart failure,||
3274|153|P|slow heartbeat, QT prolongation in the EKG), family history of||
3274|154|P|certain heart problems (QT prolongation in the EKG, sudden||
3274|155|P|cardiac death).||
3274|156|P|   Low levels of potassium or magnesium in the blood may also||
3274|157|P|increase your risk of QT prolongation. This risk may increase if||
3274|158|P|you use certain drugs (such as diuretics/"water pills") or if you||
3274|159|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3274|160|P|Talk to your doctor about using risperidone safely.||
3274|161|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3274|162|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3274|163|P|machinery, or do anything that needs alertness until you can do||
3274|164|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
3274|165|P|are using marijuana (cannabis).||
3274|166|P|   Before having surgery (including cataract/glaucoma eye||
3274|167|P|surgery), tell your doctor or dentist if you are taking or have||
3274|168|P|ever taken this medication, and about all the other products you||
3274|169|P|use (including prescription drugs, nonprescription drugs, and||
3274|170|P|herbal products).||
3274|171|P|   This medication may contain aspartame. If you have||
3274|172|P|phenylketonuria (PKU) or any other condition that requires you to||
3274|173|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
3274|174|P|doctor or pharmacist about using this medication safely.||
3274|175|P|   This medication may make you sweat less, making you more||
3274|176|P|likely to get heat stroke. Avoid doing things that may cause you||
3274|177|P|to overheat, such as hard work or exercise in hot weather, or||
3274|178|P|using hot tubs. When the weather is hot, drink a lot of fluids||
3274|179|P|and dress lightly. If you overheat, quickly look for a place to||
3274|180|P|cool down and rest. Get medical help right away if you have a||
3274|181|P|fever that does not go away, mental/mood changes, headache, or||
3274|182|P|dizziness.||
3274|183|P|   Older adults may be more sensitive to the side effects of this||
3274|184|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
3274|185|P|prolongation (see above). Drowsiness, dizziness, and||
3274|186|P|lightheadedness can increase the risk of falling.||
3274|187|P|   During pregnancy, this medication should be used only when||
3274|188|P|clearly needed. Babies born to mothers who have used this drug||
3274|189|P|during the last 3 months of pregnancy may rarely develop symptoms||
3274|190|P|including muscle stiffness or shakiness, drowsiness,||
3274|191|P|feeding/breathing difficulties, or constant crying. If you notice||
3274|192|P|any of these symptoms in your newborn especially during their||
3274|193|P|first month, tell the doctor right away.||
3274|194|P|   Since untreated mental/mood problems (such as schizophrenia,||
3274|195|P|bipolar disorder, depression) can be a serious condition, do not||
3274|196|P|stop taking this medication unless directed by your doctor. If||
3274|197|P|you are planning pregnancy, become pregnant, or think you may be||
3274|198|P|pregnant, immediately discuss with your doctor the benefits and||
3274|199|P|risks of using this medication during pregnancy.||
3274|200|P|   This medication passes into breast milk and may have||
3274|201|P|undesirable effects on a nursing infant. Tell the doctor right||
3274|202|P|away if your baby develops symptoms such as muscle stiffness or||
3274|203|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
3274|204|P|your doctor before breastfeeding.||
3274|205|B|||
3274|206|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3274|207|I|medications work or increase your risk for serious side effects.||
3274|208|I|This document does not contain all possible drug interactions.||
3274|209|I|Keep a list of all the products you use (including||
3274|210|I|prescription/nonprescription drugs and herbal products) and share||
3274|211|I|it with your doctor and pharmacist. Do not start, stop, or change||
3274|212|I|the dosage of any medicines without your doctor's approval.||
3274|213|I|   A product that may interact with this drug is: metoclopramide.||
3274|214|I|   Tell your doctor or pharmacist if you are taking other||
3274|215|I|products that cause drowsiness such as opioid pain or cough||
3274|216|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3274|217|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3274|218|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3274|219|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
3274|220|I|diphenhydramine).||
3274|221|I|   Check the labels on all your medicines (such as allergy or||
3274|222|I|cough-and-cold products) because they may contain ingredients||
3274|223|I|that cause drowsiness. Ask your pharmacist about using those||
3274|224|I|products safely.||
3274|225|B|||
3274|226|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3274|227|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3274|228|O|poison control center right away. US residents can call||
3274|229|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3274|230|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
3274|231|O|fast/irregular heartbeat, unusual/uncontrolled movements,||
3274|232|O|seizures.||
3274|233|B|||
3274|234|N|NOTES:  Do not share this medication with others.||
3274|235|N|   Lab and/or medical tests (such as blood sugar, weight, blood||
3274|236|N|pressure, blood cholesterol/triglyceride levels) should be done||
3274|237|N|while you are taking this medication. Keep all medical and lab||
3274|238|N|appointments. Consult your doctor for more details.||
3274|239|B|||
3274|240|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3274|241|D|remember. If it is near the time of the next dose, skip the||
3274|242|D|missed dose. Take your next dose at the regular time. Do not||
3274|243|D|double the dose to catch up.||
3274|244|B|||
3274|245|R|STORAGE:  Store at room temperature away from light and moisture.||
3274|246|R|Do not store in the bathroom. Keep all medications away from||
3274|247|R|children and pets.||
3274|248|R|   Do not flush medications down the toilet or pour them into a||
3274|249|R|drain unless instructed to do so. Properly discard this product||
3274|250|R|when it is expired or no longer needed. Consult your pharmacist||
3274|251|R|or local waste disposal company.||
3274|252|B|||
3274|253|A|Information last revised May 2024.||
3274|254|A|Copyright(c) 2025 First Databank, Inc.||
3274|255|B|||
3279|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3279|002|Z|does NOT have all possible information about this product. This||
3279|003|Z|information does not assure that this product is safe, effective,||
3279|004|Z|or appropriate for you. This information is not individual||
3279|005|Z|medical advice and does not substitute for the advice of your||
3279|006|Z|health care professional. Always ask your health care||
3279|007|Z|professional for complete information about this product and your||
3279|008|Z|specific health needs.||
3279|009|B|||
3279|010|T|DOCOSANOL - TOPICAL||
3279|011|F|(doe-COE-sah-noll)||
3279|012|B|||
3279|013|C|COMMON BRAND NAME(S): Abreva||
3279|014|B|||
3279|015|U|USES:  Docosanol is used to treat "cold sores/fever blisters"||
3279|016|U|(herpes labialis). It can speed up healing of the sores and||
3279|017|U|decrease symptoms (such as tingling, pain, burning, itching). It||
3279|018|U|works by blocking the virus that causes the cold sores (herpes||
3279|019|U|simplex) from entering the healthy skin cells and growing in||
3279|020|U|number. This medication does not cure herpes and does not prevent||
3279|021|U|passing the infection to someone else. It does not prevent a||
3279|022|U|future occurrence.||
3279|023|U|   Do not use this medication to treat canker sores (sores found||
3279|024|U|commonly in the mouth), shingles, or genital herpes.||
3279|025|B|||
3279|026|H|HOW TO USE:  Follow all directions on the product package, or use||
3279|027|H|as directed by your doctor. Use this medication at the first||
3279|028|H|signs of a cold sore (such as tingling, burning, redness, or a||
3279|029|H|bump). Wash and dry your hands before applying the medication.||
3279|030|H|Clean and dry the affected areas. Apply a thin layer of||
3279|031|H|medication to completely cover the area of the cold sore or the||
3279|032|H|area of tingling/itching/redness/swelling and rub in gently,||
3279|033|H|usually 5 times a day every 3-4 hours, or as directed by your||
3279|034|H|doctor. Wash your hands with soap and water after applying. If||
3279|035|H|you have any questions, ask your doctor or pharmacist.||
3279|036|H|   Apply to skin only. Do not apply this medication in or near||
3279|037|H|the eyes since this medication can irritate the eyes. If you do||
3279|038|H|get medication in your eyes, flush with plenty of water. Do not||
3279|039|H|apply inside the mouth or nose.||
3279|040|H|   Remove any cosmetics from the affected area before applying.||
3279|041|H|You may apply cosmetics after applying but use a separate||
3279|042|H|applicator (such as a disposable cotton swab) on infected areas||
3279|043|H|to prevent spreading the infection. If you accidentally wipe off||
3279|044|H|the medication, reapply as soon as possible.||
3279|045|H|   Dosage is based on your medical condition, type of infection,||
3279|046|H|and response to treatment. Do not use this drug more often or for||
3279|047|H|longer than directed.||
3279|048|H|   Use this medication regularly to get the most benefit from it.||
3279|049|H|This medication works best when the amount of drug absorbed by||
3279|050|H|the skin stays at a constant level. Use this drug at evenly||
3279|051|H|spaced intervals. To help you remember, use it at the same times||
3279|052|H|each day.||
3279|053|H|   Cold sores (herpes) can spread easily. Docosanol does not||
3279|054|H|prevent the spread of herpes. Avoid close physical contact with||
3279|055|H|others (such as kissing) during an outbreak until the cold sores||
3279|056|H|have completely healed. Also, try not to touch the cold sore, and||
3279|057|H|wash your hands if you do touch the cold sore.||
3279|058|H|   Stop using this medication and tell your doctor if your cold||
3279|059|H|sores get worse or last for more than 10 days.||
3279|060|B|||
3279|061|S|SIDE EFFECTS:  Redness or swelling may occur. If any of these||
3279|062|S|effects last or get worse, tell your doctor or pharmacist||
3279|063|S|promptly.||
3279|064|S|   If your doctor has directed you to use this medication,||
3279|065|S|remember that your doctor has judged that the benefit to you is||
3279|066|S|greater than the risk of side effects. Many people using this||
3279|067|S|medication do not have serious side effects.||
3279|068|S|   A very serious allergic reaction to this drug is rare.||
3279|069|S|However, get medical help right away if you notice any symptoms||
3279|070|S|of a serious allergic reaction, including: rash, itching/swelling||
3279|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3279|072|S|breathing.||
3279|073|S|   This is not a complete list of possible side effects. If you||
3279|074|S|notice other effects not listed above, contact your doctor or||
3279|075|S|pharmacist.||
3279|076|S|   In the US -||
3279|077|S|   Call your doctor for medical advice about side effects. You||
3279|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3279|079|S|www.fda.gov/medwatch.||
3279|080|S|   In Canada - Call your doctor for medical advice about side||
3279|081|S|effects. You may report side effects to Health Canada at||
3279|082|S|1-866-234-2345.||
3279|083|B|||
3279|084|P|PRECAUTIONS:  Before using docosanol, tell your doctor or||
3279|085|P|pharmacist if you are allergic to it; or if you have any other||
3279|086|P|allergies. This product may contain inactive ingredients, which||
3279|087|P|can cause allergic reactions or other problems. Talk to your||
3279|088|P|pharmacist for more details.||
3279|089|P|   During pregnancy, this medication should be used only when||
3279|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
3279|091|P|   It is unknown if this drug passes into breast milk. Consult||
3279|092|P|your doctor before breastfeeding.||
3279|093|B|||
3279|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3279|095|I|medications work or increase your risk for serious side effects.||
3279|096|I|This document does not contain all possible drug interactions.||
3279|097|I|Keep a list of all the products you use (including||
3279|098|I|prescription/nonprescription drugs and herbal products) and share||
3279|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
3279|100|I|the dosage of any medicines without your doctor's approval.||
3279|101|B|||
3279|102|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3279|103|O|has overdosed and has serious symptoms such as passing out or||
3279|104|O|trouble breathing, call 911. Otherwise, call a poison control||
3279|105|O|center right away. US residents can call 1-800-222-1222. Canada||
3279|106|O|residents can call 1-844-764-7669.||
3279|107|B|||
3279|108|N|NOTES:  Do not share this medication with others. Doing so may||
3279|109|N|spread the infection.||
3279|110|N|   Cold sore outbreaks can be caused by many factors such as||
3279|111|N|stress, hormonal changes (such as pregnancy, menstrual period),||
3279|112|N|injury/surgery on the mouth (such as dental work), tiredness,||
3279|113|N|sunlight, cold weather, or fever/cold/flu.||
3279|114|B|||
3279|115|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3279|116|D|If it is near the time of the next dose, skip the missed dose.||
3279|117|D|Use your next dose at the regular time. Do not double the dose to||
3279|118|D|catch up.||
3279|119|B|||
3279|120|R|STORAGE:  Store at room temperature. Protect from freezing. If||
3279|121|R|you have any questions about storage, ask your pharmacist. Keep||
3279|122|R|all medications away from children and pets.||
3279|123|R|   Do not flush medications down the toilet or pour them into a||
3279|124|R|drain unless instructed to do so. Properly discard this product||
3279|125|R|when it is expired or no longer needed. Consult your pharmacist||
3279|126|R|or local waste disposal company.||
3279|127|B|||
3279|128|A|Information last revised May 2024.||
3279|129|A|Copyright(c) 2025 First Databank, Inc.||
3279|130|B|||
3281|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3281|002|Z|does NOT have all possible information about this product. This||
3281|003|Z|information does not assure that this product is safe, effective,||
3281|004|Z|or appropriate for you. This information is not individual||
3281|005|Z|medical advice and does not substitute for the advice of your||
3281|006|Z|health care professional. Always ask your health care||
3281|007|Z|professional for complete information about this product and your||
3281|008|Z|specific health needs.||
3281|009|B|||
3281|010|T|ENALAPRIL - ORAL||
3281|011|F|(e-NAL-a-pril)||
3281|012|B|||
3281|013|C|COMMON BRAND NAME(S): Vasotec||
3281|014|B|||
3281|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
3281|016|W|unborn baby if used during pregnancy. It is important to prevent||
3281|017|W|pregnancy while taking this medication. Consult your doctor for||
3281|018|W|more details and to discuss the use of reliable forms of birth||
3281|019|W|control while taking this medication. If you are planning||
3281|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
3281|021|W|your doctor right away.||
3281|022|B|||
3281|023|U|USES:  Enalapril is used to treat high blood pressure. Lowering||
3281|024|U|high blood pressure helps prevent strokes, heart attacks, and||
3281|025|U|kidney problems. It is also used to treat heart failure and to||
3281|026|U|help prevent people with a certain heart problem (left||
3281|027|U|ventricular dysfunction) from developing heart failure.||
3281|028|U|   Enalapril belongs to a class of drugs known as ACE inhibitors.||
3281|029|U|It works by relaxing blood vessels so blood can flow more easily.||
3281|030|B|||
3281|031|V|OTHER USES:  This section contains uses of this drug that are not||
3281|032|V|listed in the approved professional labeling for the drug but||
3281|033|V|that may be prescribed by your health care professional. Use this||
3281|034|V|drug for a condition that is listed in this section only if it||
3281|035|V|has been so prescribed by your health care professional.||
3281|036|V|   This medication may also be used for kidney disease and to||
3281|037|V|help protect the kidneys from harm due to diabetes.||
3281|038|B|||
3281|039|H|HOW TO USE:  Take this medication by mouth with or without food||
3281|040|H|as directed by your doctor, usually once or twice daily.||
3281|041|H|   If you are using the suspension form of this medication, shake||
3281|042|H|the bottle well before each dose. Carefully measure the dose||
3281|043|H|using a special measuring device/spoon. Do not use a household||
3281|044|H|spoon because you may not get the correct dose.||
3281|045|H|   The dosage is based on your medical condition and response to||
3281|046|H|treatment. Children's dosage is also based on weight.||
3281|047|H|   Use this medication regularly in order to get the most benefit||
3281|048|H|from it. To help you remember, take it at the same time(s) each||
3281|049|H|day. Keep taking this medication even if you feel well. Most||
3281|050|H|people with high blood pressure do not feel sick.||
3281|051|H|   For the treatment of high blood pressure, it may take several||
3281|052|H|weeks before you get the full benefit of this medication. For the||
3281|053|H|treatment of heart failure, it may take weeks to months before||
3281|054|H|you get the full benefit of this medication. Tell your doctor if||
3281|055|H|your condition does not get better or if it gets worse (for||
3281|056|H|example, your blood pressure readings remain high or increase).||
3281|057|B|||
3281|058|S|SIDE EFFECTS:  Dizziness, lightheadedness, or weakness may occur||
3281|059|S|as your body adjusts to the medication. Dry cough may also occur.||
3281|060|S|If any of these effects last or get worse, tell your doctor or||
3281|061|S|pharmacist promptly.||
3281|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
3281|063|S|slowly when rising from a sitting or lying position.||
3281|064|S|   Remember that this medication has been prescribed because your||
3281|065|S|doctor has judged that the benefit to you is greater than the||
3281|066|S|risk of side effects. Many people using this medication do not||
3281|067|S|have serious side effects.||
3281|068|S|   Tell your doctor right away if you have any serious side||
3281|069|S|effects, including: fainting, symptoms of a high potassium blood||
3281|070|S|level (such as muscle weakness, slow/irregular heartbeat).||
3281|071|S|   Although enalapril may be used to prevent kidney problems or||
3281|072|S|treat people who have kidney problems, it may also rarely cause||
3281|073|S|serious kidney problems or make them worse. Your doctor will||
3281|074|S|check your kidney function while you are taking enalapril. Tell||
3281|075|S|your doctor right away if you have any signs of kidney problems||
3281|076|S|such as a change in the amount of urine.||
3281|077|S|   This drug may rarely cause serious (possibly fatal) liver||
3281|078|S|problems. Get medical help right away if you have any symptoms of||
3281|079|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
3281|080|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
3281|081|S|urine.||
3281|082|S|   A very serious allergic reaction to this drug is rare.||
3281|083|S|However, get medical help right away if you notice any symptoms||
3281|084|S|of a serious allergic reaction, including: rash, itching/swelling||
3281|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3281|086|S|breathing.||
3281|087|S|   This is not a complete list of possible side effects. If you||
3281|088|S|notice other effects not listed above, contact your doctor or||
3281|089|S|pharmacist.||
3281|090|S|   In the US -||
3281|091|S|   Call your doctor for medical advice about side effects. You||
3281|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3281|093|S|www.fda.gov/medwatch.||
3281|094|S|   In Canada - Call your doctor for medical advice about side||
3281|095|S|effects. You may report side effects to Health Canada at||
3281|096|S|1-866-234-2345.||
3281|097|B|||
3281|098|P|PRECAUTIONS:  Before taking enalapril, tell your doctor or||
3281|099|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
3281|100|P|(such as benazepril); or if you have any other allergies. This||
3281|101|P|product may contain inactive ingredients, which can cause||
3281|102|P|allergic reactions or other problems. Talk to your pharmacist for||
3281|103|P|more details.||
3281|104|P|   Before using this medication, tell your doctor or pharmacist||
3281|105|P|your medical history, especially of: history of an allergic||
3281|106|P|reaction which included swelling of the face/lips/tongue/throat||
3281|107|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
3281|108|P|dialysis), high level of potassium in the blood.||
3281|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3281|110|P|can make you more dizzy. Do not drive, use machinery, or do||
3281|111|P|anything that needs alertness until you can do it safely. Limit||
3281|112|P|alcoholic beverages. Talk to your doctor if you are using||
3281|113|P|marijuana (cannabis).||
3281|114|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
3281|115|P|and cause you to feel lightheaded. Tell your doctor if you have||
3281|116|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
3281|117|P|of fluids unless your doctor tells you not to.||
3281|118|P|   Before having surgery, tell your doctor or dentist about all||
3281|119|P|the products you use (including prescription drugs,||
3281|120|P|nonprescription drugs, and herbal products).||
3281|121|P|   This product may increase your potassium levels. Before using||
3281|122|P|potassium supplements or salt substitutes that contain potassium,||
3281|123|P|consult your doctor or pharmacist.||
3281|124|P|   Older adults may be more sensitive to the side effects of this||
3281|125|P|drug, including dizziness and increases in potassium level.||
3281|126|P|   Tell your doctor if you are pregnant or plan to become||
3281|127|P|pregnant. You should not become pregnant while using enalapril.||
3281|128|P|Enalapril may harm an unborn baby. If you become pregnant, talk||
3281|129|P|to your doctor right away about the risks and benefits of this||
3281|130|P|medication. (See also Warning section.)||
3281|131|P|   This medication passes into breast milk but is unlikely to||
3281|132|P|harm a nursing infant. Consult your doctor before breastfeeding.||
3281|133|B|||
3281|134|I|DRUG INTERACTIONS:  See also Precautions section.||
3281|135|I|   Drug interactions may change how your medications work or||
3281|136|I|increase your risk for serious side effects. This document does||
3281|137|I|not contain all possible drug interactions. Keep a list of all||
3281|138|I|the products you use (including prescription/nonprescription||
3281|139|I|drugs and herbal products) and share it with your doctor and||
3281|140|I|pharmacist. Do not start, stop, or change the dosage of any||
3281|141|I|medicines without your doctor's approval.||
3281|142|I|   Some products that may interact with this drug include:||
3281|143|I|aliskiren, certain drugs that weaken the immune system/increase||
3281|144|I|the risk of infection (such as everolimus, sirolimus), lithium,||
3281|145|I|drugs that may increase the level of potassium in the blood (such||
3281|146|I|as ARBs including losartan/valsartan, birth control pills||
3281|147|I|containing drospirenone), sacubitril.||
3281|148|I|   Some products have ingredients that could raise your blood||
3281|149|I|pressure or worsen your heart failure. Tell your pharmacist what||
3281|150|I|products you are using, and ask how to use them safely||
3281|151|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
3281|152|I|ibuprofen/naproxen).||
3281|153|I|   A very serious reaction may occur if you are getting||
3281|154|I|injections for bee/wasp sting allergy (desensitization) and are||
3281|155|I|also taking enalapril. Make sure all your doctors know which||
3281|156|I|medicines you are using.||
3281|157|B|||
3281|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3281|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3281|160|O|poison control center right away. US residents can call||
3281|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3281|162|O|Symptoms of overdose may include: severe dizziness, fainting.||
3281|163|B|||
3281|164|N|NOTES:  Do not share this medication with others.||
3281|165|N|   Lifestyle changes such as stress reduction programs, exercise||
3281|166|N|and dietary changes may increase the effectiveness of this||
3281|167|N|medicine. Talk to your doctor or pharmacist about lifestyle||
3281|168|N|changes that might benefit you.||
3281|169|N|   Lab and/or medical tests (such as kidney function, potassium||
3281|170|N|levels) should be done while you are taking this medication. Keep||
3281|171|N|all medical and lab appointments. Consult your doctor for more||
3281|172|N|details.||
3281|173|N|   Check your blood pressure regularly while taking this||
3281|174|N|medication. Learn how to monitor your own blood pressure at home,||
3281|175|N|and share the results with your doctor.||
3281|176|B|||
3281|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3281|178|D|remember. If it is near the time of the next dose, skip the||
3281|179|D|missed dose. Take your next dose at the regular time. Do not||
3281|180|D|double the dose to catch up.||
3281|181|B|||
3281|182|R|STORAGE:  Store tablets at room temperature away from light and||
3281|183|R|moisture. Do not store in the bathroom. Store the suspension in||
3281|184|R|the refrigerator. Discard any unused suspension after 30 days.||
3281|185|R|Keep all medications away from children and pets.||
3281|186|R|   Do not flush medications down the toilet or pour them into a||
3281|187|R|drain unless instructed to do so. Properly discard this product||
3281|188|R|when it is expired or no longer needed. Consult your pharmacist||
3281|189|R|or local waste disposal company.||
3281|190|B|||
3281|191|A|Information last revised September 2024.||
3281|192|A|Copyright(c) 2025 First Databank, Inc.||
3281|193|B|||
3282|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3282|002|Z|does NOT have all possible information about this product. This||
3282|003|Z|information does not assure that this product is safe, effective,||
3282|004|Z|or appropriate for you. This information is not individual||
3282|005|Z|medical advice and does not substitute for the advice of your||
3282|006|Z|health care professional. Always ask your health care||
3282|007|Z|professional for complete information about this product and your||
3282|008|Z|specific health needs.||
3282|009|B|||
3282|010|T|PSEUDOEPHEDRINE/LORATADINE 24-HOUR TABLET - ORAL||
3282|011|F|(sue-doh-eff-ED-rin/lor-AT-uh-deen)||
3282|012|B|||
3282|013|C|COMMON BRAND NAME(S): Claritin-D||
3282|014|B|||
3282|015|U|USES:  Loratadine is an antihistamine which provides relief of||
3282|016|U|seasonal allergy symptoms such as watery and itching eyes, runny||
3282|017|U|nose, and sneezing. Pseudoephedrine is a decongestant which helps||
3282|018|U|relieve a stuffy nose, promotes sinus draining, and improves||
3282|019|U|breathing.||
3282|020|U|   This medication is not recommended for use in children under||
3282|021|U|12 years of age due to the high amount of pseudoephedrine.||
3282|022|B|||
3282|023|H|HOW TO USE:  Take this medication by mouth usually once daily; or||
3282|024|H|take as directed by your doctor. Take with a full glass of water.||
3282|025|H|Swallow the tablets whole. Do not crush or chew the tablets.||
3282|026|H|Doing so can release all of the drug at once, increasing the risk||
3282|027|H|of side effects.||
3282|028|H|   Do not increase your dose or take this more often than||
3282|029|H|directed.||
3282|030|H|   Tell your doctor if your condition does not get better or if||
3282|031|H|it gets worse.||
3282|032|B|||
3282|033|S|SIDE EFFECTS:  Dry mouth, mild stomach upset, trouble sleeping,||
3282|034|S|dizziness, headache, nervousness, loss of appetite, or thirst may||
3282|035|S|occur. If any of these effects last or get worse, tell your||
3282|036|S|doctor or pharmacist promptly.||
3282|037|S|   If your doctor has directed you to use this medication,||
3282|038|S|remember that your doctor has judged that the benefit to you is||
3282|039|S|greater than the risk of side effects. Many people using this||
3282|040|S|medication do not have serious side effects.||
3282|041|S|   This medication may raise your blood pressure. Check your||
3282|042|S|blood pressure regularly and tell your doctor if the results are||
3282|043|S|high.||
3282|044|S|   Tell your doctor right away if you have any serious side||
3282|045|S|effects, including: fast/irregular heartbeat, uncontrolled||
3282|046|S|shaking or tremor, mental/mood changes (such as confusion),||
3282|047|S|difficulty urinating.||
3282|048|S|   Get medical help right away if you have any very serious side||
3282|049|S|effects, including: seizures.||
3282|050|S|   A very serious allergic reaction to this drug is rare.||
3282|051|S|However, get medical help right away if you notice any symptoms||
3282|052|S|of a serious allergic reaction, including: rash, itching/swelling||
3282|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3282|054|S|breathing.||
3282|055|S|   This is not a complete list of possible side effects. If you||
3282|056|S|notice other effects not listed above, contact your doctor or||
3282|057|S|pharmacist.||
3282|058|S|   In the US -||
3282|059|S|   Call your doctor for medical advice about side effects. You||
3282|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3282|061|S|www.fda.gov/medwatch.||
3282|062|S|   In Canada - Call your doctor for medical advice about side||
3282|063|S|effects. You may report side effects to Health Canada at||
3282|064|S|1-866-234-2345.||
3282|065|B|||
3282|066|P|PRECAUTIONS:  Before taking loratadine with pseudoephedrine, tell||
3282|067|P|your doctor or pharmacist if you are allergic to it; or to||
3282|068|P|desloratadine; or if you have any other allergies. Also, tell||
3282|069|P|your doctor if you have had serious side effects from similar||
3282|070|P|medications (such as other decongestants, including||
3282|071|P|phenylephrine). This product may contain inactive ingredients,||
3282|072|P|which can cause allergic reactions or other problems. Talk to||
3282|073|P|your pharmacist for more details.||
3282|074|P|   Before using this medication, tell your doctor or pharmacist||
3282|075|P|your medical history, especially of: kidney disease, liver||
3282|076|P|disease, problems urinating (such as due to enlarged prostate),||
3282|077|P|high blood pressure, diabetes, heart problems (such as coronary||
3282|078|P|artery disease), thyroid problems (hyperthyroidism), glaucoma.||
3282|079|P|   This drug may make you dizzy. Alcohol or marijuana can make||
3282|080|P|you more dizzy. Do not drive, use machinery, or do anything that||
3282|081|P|needs alertness until you can do it safely. Limit alcoholic||
3282|082|P|beverages. Talk to your doctor if you are using marijuana.||
3282|083|P|   Before having surgery, tell your doctor or dentist about all||
3282|084|P|the products you use (including prescription drugs,||
3282|085|P|nonprescription drugs, and herbal products).||
3282|086|P|   Older adults may be more sensitive to the side effects of this||
3282|087|P|drug, especially fast/irregular heartbeat, dizziness, problems||
3282|088|P|urinating, trouble sleeping, or confusion. Dizziness, trouble||
3282|089|P|sleeping, and confusion can increase the risk of falling.||
3282|090|P|   During pregnancy, this medication should be used only when||
3282|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
3282|092|P|   This medication passes into breast milk. Consult your doctor||
3282|093|P|before breastfeeding.||
3282|094|B|||
3282|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3282|096|I|medications work or increase your risk for serious side effects.||
3282|097|I|This document does not contain all possible drug interactions.||
3282|098|I|Keep a list of all the products you use (including||
3282|099|I|prescription/nonprescription drugs and herbal products) and share||
3282|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
3282|101|I|the dosage of any medicines without your doctor's approval.||
3282|102|I|   Taking MAO inhibitors with this medication may cause a serious||
3282|103|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
3282|104|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
3282|105|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
3282|106|I|selegiline, tranylcypromine) during treatment with this||
3282|107|I|medication. Most MAO inhibitors should also not be taken for two||
3282|108|I|weeks before treatment with this medication. Ask your doctor when||
3282|109|I|to start or stop taking this medication.||
3282|110|I|   Check the labels on all your medicines (such as cough-and-cold||
3282|111|I|products) because they may contain similar ingredients||
3282|112|I|(decongestants such as phenylephrine). Ask your pharmacist about||
3282|113|I|using those products safely.||
3282|114|I|   Loratadine is very similar to desloratadine. Do not use||
3282|115|I|medications containing desloratadine while using loratadine.||
3282|116|I|   This medication may interfere with certain lab tests (such as||
3282|117|I|allergy skin testing), possibly causing false test results. Make||
3282|118|I|sure lab personnel and all your doctors know you use this drug.||
3282|119|B|||
3282|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3282|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3282|122|O|poison control center right away. US residents can call||
3282|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3282|124|O|Symptoms of overdose may include: irregular or unusually slow or||
3282|125|O|fast heartbeat, unusual nervousness or excitement, and seizures.||
3282|126|B|||
3282|127|N|NOTES:  Do not share this medication with others.||
3282|128|B|||
3282|129|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3282|130|D|If it is near the time of the next dose, skip the missed dose.||
3282|131|D|Use your next dose at the regular time. Do not double the dose to||
3282|132|D|catch up.||
3282|133|B|||
3282|134|R|STORAGE:  Store at room temperature away from light and moisture.||
3282|135|R|Do not store in the bathroom. Keep all medications away from||
3282|136|R|children and pets.||
3282|137|R|   Do not flush medications down the toilet or pour them into a||
3282|138|R|drain unless instructed to do so. Properly discard this product||
3282|139|R|when it is expired or no longer needed. Consult your pharmacist||
3282|140|R|or local waste disposal company.||
3282|141|B|||
3282|142|A|Information last revised November 2025.||
3282|143|A|Copyright(c) 2025 First Databank, Inc.||
3282|144|B|||
3288|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3288|002|Z|does NOT have all possible information about this product. This||
3288|003|Z|information does not assure that this product is safe, effective,||
3288|004|Z|or appropriate for you. This information is not individual||
3288|005|Z|medical advice and does not substitute for the advice of your||
3288|006|Z|health care professional. Always ask your health care||
3288|007|Z|professional for complete information about this product and your||
3288|008|Z|specific health needs.||
3288|009|B|||
3288|010|T|DOXERCALCIFEROL - ORAL||
3288|011|F|(dox-er-kal-SIF-e-role)||
3288|012|B|||
3288|013|C|COMMON BRAND NAME(S): Hectorol||
3288|014|B|||
3288|015|U|USES:  This medication is used to treat people with serious||
3288|016|U|kidney disease who have high levels of a certain natural||
3288|017|U|substance (parathyroid hormone-PTH), which your body normally||
3288|018|U|makes. High PTH levels affect the balance of other minerals in||
3288|019|U|your body (calcium and phosphorus) and may result in weak bones.||
3288|020|U|Doxercalciferol is a man-made form of vitamin D. It works by||
3288|021|U|decreasing PTH levels and increasing calcium/phosphorus levels in||
3288|022|U|the body.||
3288|023|B|||
3288|024|H|HOW TO USE:  Take this medication by mouth with or without food||
3288|025|H|as directed by your doctor, usually 3 times a week on dialysis||
3288|026|H|days (such as Monday, Wednesday, Friday).||
3288|027|H|   The dosage is based on your medical condition, lab tests, and||
3288|028|H|response to treatment. Do not increase your dose, take it more||
3288|029|H|often, or stop taking this medication without your doctor's||
3288|030|H|approval.||
3288|031|H|   It is very important to follow the diet recommended by your||
3288|032|H|doctor to get the most benefit from this medication and to||
3288|033|H|prevent serious side effects. Do not take more than 2 grams of||
3288|034|H|calcium a day while you are taking this medication. Sources of||
3288|035|H|calcium include your diet, phosphate binders, or calcium||
3288|036|H|supplements. If you have any questions about how much calcium you||
3288|037|H|take in a day, ask your doctor or pharmacist. Do not take other||
3288|038|H|supplements/vitamins (such as vitamin D) unless otherwise||
3288|039|H|directed by your doctor. (See also Drug Interactions section.)||
3288|040|H|   Use this medication regularly to get the most benefit from it.||
3288|041|H|To help you remember, take it at the same time each day that you||
3288|042|H|have a prescribed dose.||
3288|043|B|||
3288|044|S|SIDE EFFECTS:  Headache, upset stomach, constipation, nausea,||
3288|045|S|vomiting, or tiredness may occur. If any of these effects last or||
3288|046|S|get worse, tell your doctor or pharmacist promptly.||
3288|047|S|   Remember that this medication has been prescribed because your||
3288|048|S|doctor has judged that the benefit to you is greater than the||
3288|049|S|risk of side effects. Many people using this medication do not||
3288|050|S|have serious side effects.||
3288|051|S|   Tell your doctor right away if you have any serious side||
3288|052|S|effects, including: bone/joint/muscle pain, loss of appetite,||
3288|053|S|increased thirst, increased urination, fast/slow/irregular||
3288|054|S|heartbeat, mental/mood changes (such as drowsiness,||
3288|055|S|disturbed/irrational thoughts or beliefs), metallic taste in||
3288|056|S|mouth, weakness, unexplained weight gain or loss.||
3288|057|S|   A very serious allergic reaction to this drug is rare.||
3288|058|S|However, get medical help right away if you notice any symptoms||
3288|059|S|of a serious allergic reaction, including: rash, itching/swelling||
3288|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3288|061|S|breathing.||
3288|062|S|   This is not a complete list of possible side effects. If you||
3288|063|S|notice other effects not listed above, contact your doctor or||
3288|064|S|pharmacist.||
3288|065|S|   In the US -||
3288|066|S|   Call your doctor for medical advice about side effects. You||
3288|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3288|068|S|www.fda.gov/medwatch.||
3288|069|S|   In Canada - Call your doctor for medical advice about side||
3288|070|S|effects. You may report side effects to Health Canada at||
3288|071|S|1-866-234-2345.||
3288|072|B|||
3288|073|P|PRECAUTIONS:  Before taking doxercalciferol, tell your doctor or||
3288|074|P|pharmacist if you are allergic to it; or to vitamin D products;||
3288|075|P|or if you have any other allergies. This product may contain||
3288|076|P|inactive ingredients, which can cause allergic reactions or other||
3288|077|P|problems. Talk to your pharmacist for more details.||
3288|078|P|   Before using this medication, tell your doctor or pharmacist||
3288|079|P|your medical history, especially of: heart problems (such as||
3288|080|P|irregular heartbeat), liver disease, high calcium blood levels||
3288|081|P|(hypercalcemia), high phosphate blood levels (hyperphosphatemia),||
3288|082|P|seizure.||
3288|083|P|   Before having surgery, tell your doctor or dentist about all||
3288|084|P|the products you use (including prescription drugs,||
3288|085|P|nonprescription drugs, and herbal products).||
3288|086|P|   During pregnancy, this medication should be used only when||
3288|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
3288|088|P|   It is unknown if this medication passes into breast milk.||
3288|089|P|However, similar drugs pass into breast milk. Consult your doctor||
3288|090|P|before breastfeeding.||
3288|091|B|||
3288|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3288|093|I|medications work or increase your risk for serious side effects.||
3288|094|I|This document does not contain all possible drug interactions.||
3288|095|I|Keep a list of all the products you use (including||
3288|096|I|prescription/nonprescription drugs and herbal products) and share||
3288|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
3288|098|I|the dosage of any medicines without your doctor's approval.||
3288|099|I|   A product that may interact with this drug is: burosumab.||
3288|100|I|   Certain medications (such as bile acid sequestrants such as||
3288|101|I|cholestyramine/colestipol, mineral oil, orlistat) can decrease||
3288|102|I|the effect of doxercalciferol if taken at the same time. Avoid||
3288|103|I|taking these medications within 2 hours before or after this||
3288|104|I|medication.||
3288|105|I|   Check the labels on all your prescription and||
3288|106|I|nonprescription/herbal products (such as antacids, laxatives,||
3288|107|I|vitamins/nutritional supplements) because they may contain||
3288|108|I|calcium, magnesium, phosphate, or vitamin D. Ask your pharmacist||
3288|109|I|about using those products safely.||
3288|110|B|||
3288|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3288|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3288|113|O|poison control center right away. US residents can call||
3288|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3288|115|O|Symptoms of overdose may include: metallic taste in the mouth,||
3288|116|O|irregular heartbeat, severe mental/mood changes.||
3288|117|B|||
3288|118|N|NOTES:  Do not share this medication with others.||
3288|119|N|   Lab and/or medical tests (such as PTH levels,||
3288|120|N|calcium/magnesium/phosphorus levels) should be done while you are||
3288|121|N|taking this medication. Keep all medical and lab appointments.||
3288|122|N|Consult your doctor for more details.||
3288|123|B|||
3288|124|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3288|125|D|remember. Ask your doctor or pharmacist right away for a new||
3288|126|D|dosing schedule. Do not double the dose to catch up.||
3288|127|B|||
3288|128|R|STORAGE:  Store at room temperature away from light and moisture.||
3288|129|R|Do not store in the bathroom. Keep all medications away from||
3288|130|R|children and pets.||
3288|131|R|   Do not flush medications down the toilet or pour them into a||
3288|132|R|drain unless instructed to do so. Properly discard this product||
3288|133|R|when it is expired or no longer needed. Consult your pharmacist||
3288|134|R|or local waste disposal company.||
3288|135|B|||
3288|136|A|Information last revised May 2024.||
3288|137|A|Copyright(c) 2025 First Databank, Inc.||
3288|138|B|||
3294|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3294|002|Z|does NOT have all possible information about this product. This||
3294|003|Z|information does not assure that this product is safe, effective,||
3294|004|Z|or appropriate for you. This information is not individual||
3294|005|Z|medical advice and does not substitute for the advice of your||
3294|006|Z|health care professional. Always ask your health care||
3294|007|Z|professional for complete information about this product and your||
3294|008|Z|specific health needs.||
3294|009|B|||
3294|010|T|LOPINAVIR/RITONAVIR SOLUTION - ORAL||
3294|011|F|(loe-PIN-a-vir/ri-TOE-na-vir)||
3294|012|B|||
3294|013|C|COMMON BRAND NAME(S): Kaletra||
3294|014|B|||
3294|015|U|USES:  This combination product contains two medications:||
3294|016|U|lopinavir and ritonavir. This product is used with other HIV||
3294|017|U|medications to help control HIV infection. It helps to decrease||
3294|018|U|the amount of HIV in your body so your immune system can work||
3294|019|U|better. This lowers your chance of getting HIV complications||
3294|020|U|(such as new infections, cancer) and improves your quality of||
3294|021|U|life. Both lopinavir and ritonavir belong to a class of drugs||
3294|022|U|known as HIV protease inhibitors. Ritonavir increases ("boosts")||
3294|023|U|the levels of lopinavir. This helps lopinavir work better.||
3294|024|U|   Because this solution contains other ingredients (alcohol and||
3294|025|U|propylene glycol) that may cause side effects, it is not||
3294|026|U|recommended for premature (pre-term) newborns right after birth||
3294|027|U|or full-term newborns younger than 14 days of age, unless your||
3294|028|U|doctor thinks it is right for your baby. Discuss the risks and||
3294|029|U|benefits with your doctor.||
3294|030|U|   Lopinavir/ritonavir is not a cure for HIV infection. To||
3294|031|U|decrease your risk of spreading HIV disease to others, continue||
3294|032|U|to take all HIV medications exactly as prescribed by your doctor.||
3294|033|U|Use an effective barrier method (latex or polyurethane||
3294|034|U|condoms/dental dams) during sexual activity as directed by your||
3294|035|U|doctor. Do not share personal items (such as needles/syringes,||
3294|036|U|toothbrushes, and razors) that may have contacted blood or other||
3294|037|U|body fluids. Consult your doctor or pharmacist for more details.||
3294|038|B|||
3294|039|V|OTHER USES:  This section contains uses of this drug that are not||
3294|040|V|listed in the approved professional labeling for the drug but||
3294|041|V|that may be prescribed by your health care professional. Use this||
3294|042|V|drug for a condition that is listed in this section only if it||
3294|043|V|has been so prescribed by your health care professional.||
3294|044|V|   This product may also be used to lessen the risk of HIV||
3294|045|V|infection after contact with the virus (for example, due to a||
3294|046|V|needle stick). Ask your doctor for more details.||
3294|047|B|||
3294|048|H|HOW TO USE:  Read the Medication Guide and, if available, the||
3294|049|H|Patient Information Leaflet provided by your pharmacist before||
3294|050|H|you start taking lopinavir/ritonavir and each time you get a||
3294|051|H|refill. If you have any questions, ask your doctor or pharmacist.||
3294|052|H|   Take this medication by mouth with food as directed by your||
3294|053|H|doctor, usually twice daily. Carefully measure the dose with a||
3294|054|H|special measuring device/spoon. Do not use a household spoon||
3294|055|H|because you may not get the correct dose.||
3294|056|H|   If you are using a feeding tube, ask your doctor or pharmacist||
3294|057|H|if this medication may be given through your feeding tube.||
3294|058|H|   The dosage is based on your medical condition, response to||
3294|059|H|treatment, and other medications you may be taking. Be sure to||
3294|060|H|tell your doctor and pharmacist about all the products you use||
3294|061|H|(including prescription drugs, nonprescription drugs, and herbal||
3294|062|H|products).||
3294|063|H|   Children's dosage is also based on age and body size.||
3294|064|H|Once-daily dosing of this medication is not recommended for||
3294|065|H|children younger than 18 years of age.||
3294|066|H|   If you are taking didanosine in addition to this product, take||
3294|067|H|it one hour before or two hours after taking this product.||
3294|068|H|   It is very important to keep taking this medication (and other||
3294|069|H|HIV medications) exactly as prescribed by your doctor. Do not||
3294|070|H|skip any doses.||
3294|071|H|   For the best effect, take this medication at evenly spaced||
3294|072|H|times. To help you remember, take this medication at the same||
3294|073|H|times every day.||
3294|074|H|   Do not take more or less of this drug than prescribed or stop||
3294|075|H|taking it (or other HIV medicines) even for a short time unless||
3294|076|H|directed to do so by your doctor. Doing so may cause the amount||
3294|077|H|of virus to increase, make the infection more difficult to treat||
3294|078|H|(resistant), or worsen side effects.||
3294|079|B|||
3294|080|S|SIDE EFFECTS:  Diarrhea, headache, nausea, vomiting, stomach||
3294|081|S|upset, drowsiness, dizziness, a bad taste in the mouth, and||
3294|082|S|trouble sleeping may occur. If any of these effects last or get||
3294|083|S|worse, tell your doctor or pharmacist promptly.||
3294|084|S|   Remember that this medication has been prescribed because your||
3294|085|S|doctor has judged that the benefit to you is greater than the||
3294|086|S|risk of side effects. Many people using this medication do not||
3294|087|S|have serious side effects.||
3294|088|S|   As your immune system gets stronger, it can begin to fight off||
3294|089|S|infections you already had, possibly causing disease symptoms to||
3294|090|S|come back. You could also have symptoms if your immune system||
3294|091|S|becomes overactive. This reaction may happen at any time (soon||
3294|092|S|after starting HIV treatment or many months later). Tell your||
3294|093|S|doctor right away if you have any serious symptoms, including:||
3294|094|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
3294|095|S|that doesn't go away, headaches that are severe or don't go away,||
3294|096|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
3294|097|S|changes, signs of infection (such as sore throat that doesn't go||
3294|098|S|away, fever, chills, swollen lymph nodes, non-healing skin||
3294|099|S|sores), signs of an overactive thyroid (such as irritability,||
3294|100|S|nervousness, heat intolerance, fast/pounding/irregular||
3294|101|S|heartbeat).||
3294|102|S|   Tell your doctor right away if you have any serious side||
3294|103|S|effects, including: nausea/vomiting that doesn't stop, fever that||
3294|104|S|doesn't go away, increased thirst, increased urination, blurred||
3294|105|S|vision, confusion, stomach/abdominal pain, yellowing eyes/skin,||
3294|106|S|dark urine.||
3294|107|S|   Get medical help right away if you have any very serious side||
3294|108|S|effects, including: symptoms of a heart attack (such as||
3294|109|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
3294|110|S|severe dizziness, fainting, slow/fast/irregular heartbeat, severe||
3294|111|S|drowsiness, difficulty breathing, seizures, muscle weakness,||
3294|112|S|signs of kidney problems (such as change in the amount of urine).||
3294|113|S|   Changes in body fat may occur while you are taking this||
3294|114|S|medication (such as increased fat in the upper back and stomach||
3294|115|S|areas, decreased fat in the arms and legs). The cause and||
3294|116|S|long-term effects of these changes are unknown. Discuss the risks||
3294|117|S|and benefits of treatment with your doctor, as well as the||
3294|118|S|possible use of exercise to reduce this side effect.||
3294|119|S|   This medication may cause an increase in blood fat levels||
3294|120|S|(cholesterol and triglycerides). Cholesterol and triglyceride||
3294|121|S|testing should be done before and occasionally during treatment||
3294|122|S|with this medication. Consult your doctor or pharmacist for more||
3294|123|S|information.||
3294|124|S|   A very serious allergic reaction to this drug is rare.||
3294|125|S|However, get medical help right away if you notice any symptoms||
3294|126|S|of a serious allergic reaction, including: rash, itching/swelling||
3294|127|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3294|128|S|breathing.||
3294|129|S|   This is not a complete list of possible side effects. If you||
3294|130|S|notice other effects not listed above, contact your doctor or||
3294|131|S|pharmacist.||
3294|132|S|   In the US -||
3294|133|S|   Call your doctor for medical advice about side effects. You||
3294|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3294|135|S|www.fda.gov/medwatch.||
3294|136|S|   In Canada - Call your doctor for medical advice about side||
3294|137|S|effects. You may report side effects to Health Canada at||
3294|138|S|1-866-234-2345.||
3294|139|B|||
3294|140|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
3294|141|P|pharmacist if you are allergic to either lopinavir or ritonavir;||
3294|142|P|or if you have any other allergies. This product may contain||
3294|143|P|inactive ingredients, which can cause allergic reactions or other||
3294|144|P|problems. Talk to your pharmacist for more details.||
3294|145|P|   Before using this medication, tell your doctor or pharmacist||
3294|146|P|your medical history, especially of: liver disease, diabetes,||
3294|147|P|pancreatitis, high blood fat levels (cholesterol/triglycerides),||
3294|148|P|heart problems (coronary artery disease, heart attack), bleeding||
3294|149|P|problems (such as hemophilia), previous infection with certain||
3294|150|P|diseases (such as hepatitis B infection, hepatitis C infection,||
3294|151|P|tuberculosis).||
3294|152|P|   Lopinavir/ritonavir may cause a condition that affects the||
3294|153|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
3294|154|P|serious (rarely fatal) fast/irregular heartbeat and other||
3294|155|P|symptoms (such as severe dizziness, fainting) that need medical||
3294|156|P|attention right away.||
3294|157|P|   The risk of QT prolongation may be increased if you have||
3294|158|P|certain medical conditions or are taking other drugs that may||
3294|159|P|cause QT prolongation. Before using lopinavir/ritonavir, tell||
3294|160|P|your doctor or pharmacist of all the drugs you take and if you||
3294|161|P|have any of the following conditions: certain heart problems||
3294|162|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
3294|163|P|family history of certain heart problems (QT prolongation in the||
3294|164|P|EKG, sudden cardiac death).||
3294|165|P|   Low levels of potassium or magnesium in the blood may also||
3294|166|P|increase your risk of QT prolongation. This risk may increase if||
3294|167|P|you use certain drugs (such as diuretics/"water pills") or if you||
3294|168|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3294|169|P|Talk to your doctor about using lopinavir/ritonavir safely.||
3294|170|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3294|171|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3294|172|P|machinery, or do anything that needs alertness until you can do||
3294|173|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
3294|174|P|are using marijuana (cannabis).||
3294|175|P|   Before having surgery, tell your doctor or dentist about all||
3294|176|P|the products you use (including prescription drugs,||
3294|177|P|nonprescription drugs, and herbal products).||
3294|178|P|   Children may be more sensitive to the side effects of this||
3294|179|P|drug, especially severe drowsiness and breathing changes. The||
3294|180|P|alcohol in this product may cause an accidental overdose that||
3294|181|P|could be serious. The propylene glycol in this product may also||
3294|182|P|cause serious side effects in children, especially in premature||
3294|183|P|(pre-term) newborns and full-term newborns less than 14 days old.||
3294|184|P|   Older adults may be more sensitive to the side effects of this||
3294|185|P|drug, especially QT prolongation (see above).||
3294|186|P|   Tell your doctor if you are pregnant before using this||
3294|187|P|medication. Treatment can lower the risk of passing HIV infection||
3294|188|P|to your baby. The solution form of this medication is not||
3294|189|P|recommended during pregnancy since it contains alcohol. The||
3294|190|P|tablet form of this medication may be used. Discuss the risks and||
3294|191|P|benefits with your doctor.||
3294|192|P|   This medication passes into breast milk. Because breast milk||
3294|193|P|may transmit HIV, consult your doctor before breastfeeding.||
3294|194|B|||
3294|195|I|DRUG INTERACTIONS:  See also How to Use section.||
3294|196|I|   Drug interactions may change how your medications work or||
3294|197|I|increase your risk for serious side effects. This document does||
3294|198|I|not contain all possible drug interactions. Keep a list of all||
3294|199|I|the products you use (including prescription/nonprescription||
3294|200|I|drugs and herbal products) and share it with your doctor and||
3294|201|I|pharmacist. Do not start, stop, or change the dosage of any||
3294|202|I|medicines without your doctor's approval.||
3294|203|I|   Lopinavir/ritonavir interacts with many medications. Some||
3294|204|I|products that may interact with this drug include: cobicistat,||
3294|205|I|certain HIV medications (such as fosamprenavir, tipranavir),||
3294|206|I|orlistat.||
3294|207|I|   Other medications can affect the removal of||
3294|208|I|lopinavir/ritonavir from your body, which may affect how||
3294|209|I|lopinavir/ritonavir works. Examples include apalutamide,||
3294|210|I|rifampin, St. John's wort, among others.||
3294|211|I|   Lopinavir/ritonavir can speed up or slow down the removal of||
3294|212|I|other medications from your body, which may affect how they work.||
3294|213|I|Examples of affected drugs include certain alpha blockers (such||
3294|214|I|as alfuzosin, tamsulosin), certain inhaled drugs to treat||
3294|215|I|breathing problems (such as fluticasone, salmeterol), drugs to||
3294|216|I|treat erectile dysfunction-ED or pulmonary hypertension (such as||
3294|217|I|sildenafil, tadalafil), ergot drugs (such as ergotamine,||
3294|218|I|dihydroergotamine), pimozide, rivaroxaban, certain sedatives||
3294|219|I|(such as midazolam, triazolam), certain statins (such as||
3294|220|I|lovastatin, simvastatin), among others.||
3294|221|I|   Lopinavir/ritonavir solution contains alcohol. Severe nausea||
3294|222|I|and vomiting may occur if you are also taking certain drugs that||
3294|223|I|interact with alcohol (such as disulfiram, metronidazole,||
3294|224|I|tinidazole). Consult your doctor or pharmacist for details.||
3294|225|I|   This medication may decrease the effectiveness of hormonal||
3294|226|I|birth control such as pills, patch, or ring. This could cause||
3294|227|I|pregnancy. Discuss with your doctor or pharmacist if you should||
3294|228|I|use reliable backup birth control methods while using this||
3294|229|I|medication. Also tell your doctor if you have any new spotting or||
3294|230|I|breakthrough bleeding, because these may be signs that your birth||
3294|231|I|control is not working well.||
3294|232|I|   Tell your doctor or pharmacist if you are taking other||
3294|233|I|products that cause drowsiness including other drugs that contain||
3294|234|I|alcohol, marijuana (cannabis), antihistamines (such as||
3294|235|I|cetirizine, diphenhydramine), drugs for sleep or anxiety (such as||
3294|236|I|alprazolam, diazepam, zolpidem), muscle relaxants, and opioid||
3294|237|I|pain relievers (such as codeine).||
3294|238|I|   Check the labels on all your medicines (such as allergy or||
3294|239|I|cough-and-cold products) because they may contain ingredients||
3294|240|I|that cause drowsiness. Ask your pharmacist about using those||
3294|241|I|products safely.||
3294|242|I|   Many drugs besides lopinavir/ritonavir may affect the heart||
3294|243|I|rhythm (QT prolongation), including pacritinib, among others.||
3294|244|B|||
3294|245|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3294|246|O|as passing out or trouble breathing, or if a child accidentally||
3294|247|O|swallows this medication, call 911. Otherwise, call a poison||
3294|248|O|control center right away. US residents can call 1-800-222-1222.||
3294|249|O|Canada residents can call 1-844-764-7669. Symptoms of overdose||
3294|250|O|may include: numbness or tingling in the arms/hands/legs/feet, a||
3294|251|O|change in amount of urine, severe drowsiness/dizziness, loss of||
3294|252|O|consciousness, shallow breathing.||
3294|253|B|||
3294|254|N|NOTES:  Do not share this medication with others.||
3294|255|N|   Lab and/or medical tests (such as liver function, blood count,||
3294|256|N|blood cholesterol/triglyceride levels, blood sugar) should be||
3294|257|N|done while you are taking this medication. Keep all medical and||
3294|258|N|lab appointments. Consult your doctor for more details.||
3294|259|N|   Lopinavir/ritonavir is available in tablets, capsules, and||
3294|260|N|oral solution. Do not switch types of this medication without||
3294|261|N|instructions on how to do so by your doctor.||
3294|262|B|||
3294|263|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3294|264|D|remember. If it is near the time of the next dose, skip the||
3294|265|D|missed dose. Take your next dose at the regular time. Do not||
3294|266|D|double the dose to catch up.||
3294|267|B|||
3294|268|R|STORAGE:  Different brands of this medication have different||
3294|269|R|storage needs. Check the product package for instructions on how||
3294|270|R|to store your brand, or ask your pharmacist. Keep all medications||
3294|271|R|away from children and pets.||
3294|272|R|   Do not flush medications down the toilet or pour them into a||
3294|273|R|drain unless instructed to do so. Properly discard this product||
3294|274|R|when it is expired or no longer needed. Consult your pharmacist||
3294|275|R|or local waste disposal company.||
3294|276|B|||
3294|277|A|Information last revised April 2025.||
3294|278|A|Copyright(c) 2025 First Databank, Inc.||
3294|279|B|||
3295|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3295|002|Z|does NOT have all possible information about this product. This||
3295|003|Z|information does not assure that this product is safe, effective,||
3295|004|Z|or appropriate for you. This information is not individual||
3295|005|Z|medical advice and does not substitute for the advice of your||
3295|006|Z|health care professional. Always ask your health care||
3295|007|Z|professional for complete information about this product and your||
3295|008|Z|specific health needs.||
3295|009|B|||
3295|010|T|AMOXICILLIN - ORAL||
3295|011|F|(a-MOX-i-SIL-in)||
3295|012|B|||
3295|013|C|COMMON BRAND NAME(S): Amoxil||
3295|014|B|||
3295|015|U|USES:  Amoxicillin is used to treat a wide variety of bacterial||
3295|016|U|infections. This medication is a penicillin-type antibiotic. It||
3295|017|U|works by stopping the growth of bacteria.||
3295|018|U|   This antibiotic treats only bacterial infections. It will not||
3295|019|U|work for viral infections (such as common cold, flu). Using any||
3295|020|U|antibiotic when it is not needed can cause it to not work for||
3295|021|U|future infections.||
3295|022|U|   Amoxicillin is also used with other medications to treat||
3295|023|U|stomach/intestinal ulcers caused by the bacteria H. pylori and to||
3295|024|U|prevent the ulcers from returning.||
3295|025|B|||
3295|026|V|OTHER USES:  This section contains uses of this drug that are not||
3295|027|V|listed in the approved US professional labeling for the drug but||
3295|028|V|that may be prescribed by your health care professional. Use this||
3295|029|V|drug for a condition that is listed in this section only if it||
3295|030|V|has been so prescribed by your health care professional.||
3295|031|V|   This drug may also be used before medical/dental procedures by||
3295|032|V|people with certain heart conditions (such as heart valve||
3295|033|V|disease) to reduce the risk of a serious heart infection.||
3295|034|B|||
3295|035|H|HOW TO USE:  Take this medication by mouth with or without food||
3295|036|H|as directed by your doctor, usually every 8 or 12 hours. The||
3295|037|H|dosage is based on your medical condition and response to||
3295|038|H|treatment.||
3295|039|H|   Drink plenty of fluids while using this medication unless your||
3295|040|H|doctor tells you otherwise.||
3295|041|H|   For the best effect, take this antibiotic at evenly spaced||
3295|042|H|times. To help you remember, take this medication at the same||
3295|043|H|time(s) every day.||
3295|044|H|   Continue to take this medication until the full prescribed||
3295|045|H|amount is finished, even if symptoms disappear after a few days.||
3295|046|H|Stopping the medication too early may result in a return of the||
3295|047|H|infection.||
3295|048|H|   Tell your doctor if your condition lasts or gets worse.||
3295|049|B|||
3295|050|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. If any of||
3295|051|S|these effects last or get worse, tell your doctor or pharmacist||
3295|052|S|promptly.||
3295|053|S|   Remember that this medication has been prescribed because your||
3295|054|S|doctor has judged that the benefit to you is greater than the||
3295|055|S|risk of side effects. Many people using this medication do not||
3295|056|S|have serious side effects.||
3295|057|S|   Use of this medication for prolonged or repeated periods may||
3295|058|S|result in oral thrush or a new vaginal yeast infection (oral or||
3295|059|S|vaginal fungal infection). Contact your doctor if you notice||
3295|060|S|white patches in your mouth, a change in vaginal discharge or||
3295|061|S|other new symptoms.||
3295|062|S|   Tell your doctor right away if you have any serious side||
3295|063|S|effects, including: signs of liver disease (such as||
3295|064|S|nausea/vomiting that doesn't stop, loss of appetite,||
3295|065|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
3295|066|S|bruising or bleeding.||
3295|067|S|   This medication may rarely cause a severe intestinal condition||
3295|068|S|due to a bacteria called C. difficile. This condition may occur||
3295|069|S|during treatment or weeks to months after treatment has stopped.||
3295|070|S|Tell your doctor right away if you develop: diarrhea that doesn't||
3295|071|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
3295|072|S|stool.||
3295|073|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
3295|074|S|products because they may make symptoms worse.||
3295|075|S|   A very serious allergic reaction to this drug is rare.||
3295|076|S|However, get medical help right away if you notice any symptoms||
3295|077|S|of a serious allergic reaction, including: fever that doesn't go||
3295|078|S|away, new or worsening lymph node swelling, rash,||
3295|079|S|itching/swelling (especially of the face/tongue/throat), severe||
3295|080|S|dizziness, trouble breathing.||
3295|081|S|   Amoxicillin can commonly cause a mild rash that is usually not||
3295|082|S|serious. However, you may not be able to tell it apart from a||
3295|083|S|rare rash that could be a sign of a severe allergic reaction. Get||
3295|084|S|medical help right away if you develop any rash.||
3295|085|S|   This is not a complete list of possible side effects. If you||
3295|086|S|notice other effects not listed above, contact your doctor or||
3295|087|S|pharmacist.||
3295|088|S|   In the US -||
3295|089|S|   Call your doctor for medical advice about side effects. You||
3295|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3295|091|S|www.fda.gov/medwatch.||
3295|092|S|   In Canada - Call your doctor for medical advice about side||
3295|093|S|effects. You may report side effects to Health Canada at||
3295|094|S|1-866-234-2345.||
3295|095|B|||
3295|096|P|PRECAUTIONS:  Before taking amoxicillin, tell your doctor or||
3295|097|P|pharmacist if you are allergic to it; or to penicillin or||
3295|098|P|cephalosporin antibiotics; or if you have any other allergies.||
3295|099|P|This product may contain inactive ingredients, which can cause||
3295|100|P|allergic reactions or other problems. Talk to your pharmacist for||
3295|101|P|more details.||
3295|102|P|   Before using this medication, tell your doctor or pharmacist||
3295|103|P|your medical history, especially of: kidney disease, a certain||
3295|104|P|type of viral infection (infectious mononucleosis).||
3295|105|P|   Amoxicillin may cause live bacterial vaccines (such as typhoid||
3295|106|P|vaccine) to not work well. Tell your health care professional||
3295|107|P|that you are using amoxicillin before having any||
3295|108|P|immunizations/vaccinations.||
3295|109|P|   Before having surgery, tell your doctor or dentist about all||
3295|110|P|the products you use (including prescription drugs,||
3295|111|P|nonprescription drugs, and herbal products).||
3295|112|P|   During pregnancy, this medication should be used only when||
3295|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
3295|114|P|   Amoxicillin passes into breast milk. Consult your doctor||
3295|115|P|before breastfeeding.||
3295|116|B|||
3295|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3295|118|I|medications work or increase your risk for serious side effects.||
3295|119|I|This document does not contain all possible drug interactions.||
3295|120|I|Keep a list of all the products you use (including||
3295|121|I|prescription/nonprescription drugs and herbal products) and share||
3295|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
3295|123|I|the dosage of any medicines without your doctor's approval.||
3295|124|I|   A product that may interact with this drug is: methotrexate.||
3295|125|I|   This medication may interfere with certain lab tests (such as||
3295|126|I|certain diabetic urine tests), possibly causing false test||
3295|127|I|results. Make sure lab personnel and all your doctors know you||
3295|128|I|use this drug.||
3295|129|B|||
3295|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3295|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3295|132|O|poison control center right away. US residents can call||
3295|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3295|134|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
3295|135|O|severe vomiting, a severe decrease in the amount of urine, or||
3295|136|O|seizures.||
3295|137|B|||
3295|138|N|NOTES:  Do not share this medication with others.||
3295|139|N|   This medication has been prescribed for your current condition||
3295|140|N|only. Do not use it later for another infection unless your||
3295|141|N|doctor tells you to.||
3295|142|N|   With prolonged treatment, lab and/or medical tests (such as||
3295|143|N|kidney/liver function, complete blood counts) may be done while||
3295|144|N|you are taking this medication. Keep all medical and lab||
3295|145|N|appointments. Consult your doctor for more details.||
3295|146|B|||
3295|147|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3295|148|D|If it is near the time of the next dose, skip the missed dose.||
3295|149|D|Use your next dose at the regular time. Do not double the dose to||
3295|150|D|catch up.||
3295|151|B|||
3295|152|R|STORAGE:  Store at room temperature away from light and moisture.||
3295|153|R|Do not store in the bathroom. Keep all medications away from||
3295|154|R|children and pets.||
3295|155|R|   Do not flush medications down the toilet or pour them into a||
3295|156|R|drain unless instructed to do so. Properly discard this product||
3295|157|R|when it is expired or no longer needed. Consult your pharmacist||
3295|158|R|or local waste disposal company.||
3295|159|B|||
3295|160|A|Information last revised May 2024.||
3295|161|A|Copyright(c) 2025 First Databank, Inc.||
3295|162|B|||
3301|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3301|002|Z|does NOT have all possible information about this product. This||
3301|003|Z|information does not assure that this product is safe, effective,||
3301|004|Z|or appropriate for you. This information is not individual||
3301|005|Z|medical advice and does not substitute for the advice of your||
3301|006|Z|health care professional. Always ask your health care||
3301|007|Z|professional for complete information about this product and your||
3301|008|Z|specific health needs.||
3301|009|B|||
3301|010|T|MYCOPHENOLATE MOFETIL SUSPENSION - ORAL||
3301|011|F|(my-coh-FEN-oh-late MOW-fet-ill)||
3301|012|B|||
3301|013|C|COMMON BRAND NAME(S): Cellcept, Myhibbin||
3301|014|B|||
3301|015|W|WARNING:  Mycophenolate may lower your ability to fight||
3301|016|W|infections. This may make you more likely to get a serious||
3301|017|W|(rarely fatal) infection or make any infection you have worse.||
3301|018|W|Tell your doctor right away if you have any signs of infection||
3301|019|W|(such as sore throat that doesn't go away, fever, chills,||
3301|020|W|burning/painful/urgent urination, change in the amount of urine).||
3301|021|W|   Mycophenolate may rarely cause cancer (such as lymphoma, skin||
3301|022|W|cancer). Protect your skin from the sun. Avoid prolonged sun||
3301|023|W|exposure, tanning booths, and sunlamps. Use a sunscreen and wear||
3301|024|W|protective clothing when outdoors. Tell your doctor right away if||
3301|025|W|you have any of the following symptoms of cancer: swollen lymph||
3301|026|W|nodes, sudden weight loss, night sweats, change in appearance or||
3301|027|W|size of moles, or unusual skin changes/growth.||
3301|028|W|   Mycophenolate may harm an unborn baby. When using||
3301|029|W|mycophenolate, men and women must use reliable forms of birth||
3301|030|W|control. See also Precautions section.||
3301|031|B|||
3301|032|U|USES:  Mycophenolate is used in combination with other||
3301|033|U|medications to keep your body from attacking and rejecting your||
3301|034|U|transplanted organ (such as kidney, liver, heart). It belongs to||
3301|035|U|a class of medications called immunosuppressants. It works by||
3301|036|U|weakening your body's defense system (immune system) to help your||
3301|037|U|body accept the new organ as if it were your own.||
3301|038|B|||
3301|039|V|OTHER USES:  This section contains uses of this drug that are not||
3301|040|V|listed in the approved professional labeling for the drug but||
3301|041|V|that may be prescribed by your health care professional. Use this||
3301|042|V|drug for a condition that is listed in this section only if it||
3301|043|V|has been so prescribed by your health care professional.||
3301|044|V|   This drug may also be used for immune system disorders.||
3301|045|B|||
3301|046|H|HOW TO USE:  Read the Medication Guide and, if available, the||
3301|047|H|Instructions for Use provided by your pharmacist before you start||
3301|048|H|taking mycophenolate and each time you get a refill. If you have||
3301|049|H|any questions, ask your doctor or pharmacist.||
3301|050|H|   Take this medication by mouth as directed by your doctor,||
3301|051|H|usually twice daily on an empty stomach, 1 hour before or 2 hours||
3301|052|H|after meals.||
3301|053|H|   Shake the bottle well before each dose. Carefully measure the||
3301|054|H|dose using a special measuring device/spoon. Do not use a||
3301|055|H|household spoon because you may not get the correct dose. Do not||
3301|056|H|mix the suspension with any other medication.||
3301|057|H|   Avoid getting any of the suspension on your skin or in your||
3301|058|H|eyes. If contact occurs, wash the affected skin area well with||
3301|059|H|soap and water or rinse your eyes with plain water. Consult your||
3301|060|H|pharmacist for details.||
3301|061|H|   Since this drug can be absorbed through the skin and may harm||
3301|062|H|an unborn baby, women who are pregnant or who may become pregnant||
3301|063|H|should not handle this medication.||
3301|064|H|   The dosage is based on your medical condition and response to||
3301|065|H|treatment. Children's dosage is also based on body size.||
3301|066|H|   Use this medication regularly to get the most benefit from it.||
3301|067|H|To help you remember, take it at the same times each day.||
3301|068|H|   Keep taking this medication even if you feel well. Do not stop||
3301|069|H|taking mycophenolate without first talking to your doctor.||
3301|070|H|   Certain products may make it harder for your body to absorb||
3301|071|H|mycophenolate if they are taken at the same time. Do not take||
3301|072|H|this medication at the same time as antacids containing aluminum||
3301|073|H|and/or magnesium, cholestyramine, colestipol, or calcium-free||
3301|074|H|phosphate binders (such as aluminum products, lanthanum,||
3301|075|H|sevelamer). Ask your pharmacist for more details.||
3301|076|H|   Do not change brands or forms of mycophenolate unless directed||
3301|077|H|by your doctor.||
3301|078|B|||
3301|079|S|SIDE EFFECTS:  See also Warning section.||
3301|080|S|   Constipation, nausea, headache, diarrhea, vomiting, stomach||
3301|081|S|upset, gas, tremor, dizziness, drowsiness, or trouble sleeping||
3301|082|S|may occur. If any of these effects last or get worse, tell your||
3301|083|S|doctor or pharmacist promptly.||
3301|084|S|   Remember that this medication has been prescribed because your||
3301|085|S|doctor has judged that the benefit to you is greater than the||
3301|086|S|risk of side effects. Many people using this medication do not||
3301|087|S|have serious side effects.||
3301|088|S|   Tell your doctor right away if you have any serious side||
3301|089|S|effects, including: unusual tiredness, fast/irregular heartbeat,||
3301|090|S|easy bleeding/bruising, swelling of the feet or ankles, joint||
3301|091|S|pain/stiffness, muscle pain.||
3301|092|S|   Get medical help right away if you have any very serious side||
3301|093|S|effects, including: stomach/abdominal pain that doesn't go away,||
3301|094|S|black stools, vomit that looks like coffee grounds, chest pain,||
3301|095|S|shortness of breath/rapid breathing.||
3301|096|S|   This medication may increase your risk of getting a rare but||
3301|097|S|very serious (possibly fatal) brain infection (progressive||
3301|098|S|multifocal leukoencephalopathy-PML). Get medical help right away||
3301|099|S|if you have any of these side effects: clumsiness, loss of||
3301|100|S|coordination/balance, weakness, sudden change in your thinking||
3301|101|S|(such as confusion, difficulty concentrating, memory loss),||
3301|102|S|difficulty talking/walking, seizure, vision changes.||
3301|103|S|   A very serious allergic reaction to this drug is rare.||
3301|104|S|However, get medical help right away if you notice any symptoms||
3301|105|S|of a serious allergic reaction, including: rash, itching/swelling||
3301|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3301|107|S|breathing.||
3301|108|S|   This is not a complete list of possible side effects. If you||
3301|109|S|notice other effects not listed above, contact your doctor or||
3301|110|S|pharmacist.||
3301|111|S|   In the US -||
3301|112|S|   Call your doctor for medical advice about side effects. You||
3301|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3301|114|S|www.fda.gov/medwatch.||
3301|115|S|   In Canada - Call your doctor for medical advice about side||
3301|116|S|effects. You may report side effects to Health Canada at||
3301|117|S|1-866-234-2345.||
3301|118|B|||
3301|119|P|PRECAUTIONS:  See also Warning section.||
3301|120|P|   Before taking mycophenolate mofetil, tell your doctor or||
3301|121|P|pharmacist if you are allergic to it; or to mycophenolic acid; or||
3301|122|P|to mycophenolate sodium; or if you have any other allergies. This||
3301|123|P|product may contain inactive ingredients, which can cause||
3301|124|P|allergic reactions or other problems. Talk to your pharmacist for||
3301|125|P|more details.||
3301|126|P|   Before using this medication, tell your doctor or pharmacist||
3301|127|P|your medical history, especially of: cancer, liver disease (such||
3301|128|P|as hepatitis B, hepatitis C), kidney disease, current/past||
3301|129|P|infections (such as herpes, shingles), stomach/intestinal||
3301|130|P|problems (such as ulcers), rare genetic disorders (such as||
3301|131|P|Lesch-Nyhan or Kelley-Seegmiller syndromes).||
3301|132|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3301|133|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3301|134|P|machinery, or do anything that needs alertness until you can do||
3301|135|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
3301|136|P|are using marijuana (cannabis).||
3301|137|P|   This medication may contain aspartame. If you have||
3301|138|P|phenylketonuria (PKU) or any other condition that requires you to||
3301|139|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
3301|140|P|doctor or pharmacist about using this medication safely.||
3301|141|P|   Mycophenolate can make you more likely to get infections or||
3301|142|P|may make current infections worse. Stay away from anyone who has||
3301|143|P|an infection that may easily spread (such as chickenpox,||
3301|144|P|COVID-19, measles, flu). Talk to your doctor if you have been||
3301|145|P|exposed to an infection or for more details.||
3301|146|P|   Tell your health care professional that you are using||
3301|147|P|mycophenolate mofetil before having any||
3301|148|P|immunizations/vaccinations. Avoid contact with people who have||
3301|149|P|recently received live vaccines (such as flu vaccine inhaled||
3301|150|P|through the nose).||
3301|151|P|   To lower the chance of getting cut, bruised, or injured, use||
3301|152|P|caution with sharp objects like razors and nail cutters, and||
3301|153|P|avoid activities such as contact sports.||
3301|154|P|   Before having surgery, tell your doctor or dentist about all||
3301|155|P|the products you use (including prescription drugs,||
3301|156|P|nonprescription drugs, and herbal products).||
3301|157|P|   Do not donate blood while using mycophenolate and for 6 weeks||
3301|158|P|after stopping this drug. Do not donate sperm while using||
3301|159|P|mycophenolate and for 90 days after stopping this drug.||
3301|160|P|   Since this drug can be absorbed through the skin and lungs and||
3301|161|P|may harm an unborn baby, women who are pregnant or who may become||
3301|162|P|pregnant should not handle this medication or breathe the powder||
3301|163|P|from this medication before it is mixed into a suspension.||
3301|164|P|   Tell your doctor if you are pregnant or plan to become||
3301|165|P|pregnant. You should not become pregnant while using||
3301|166|P|mycophenolate. Mycophenolate may harm an unborn baby. Your doctor||
3301|167|P|should order a pregnancy test before you start this medication.||
3301|168|P|Women using this medication should ask about reliable forms of||
3301|169|P|birth control during treatment and for 6 weeks after the last||
3301|170|P|dose. Men using this medication should ask about reliable forms||
3301|171|P|of birth control during treatment and for 3 months after the last||
3301|172|P|dose. If you or your partner becomes pregnant, talk to your||
3301|173|P|doctor right away about the risks and benefits of this||
3301|174|P|medication.||
3301|175|P|   It is unknown if this drug passes into breast milk. Because of||
3301|176|P|the possible risk to the infant, breastfeeding is not recommended||
3301|177|P|while using this drug. Consult your doctor before breastfeeding.||
3301|178|B|||
3301|179|I|DRUG INTERACTIONS:  See also How to Use section.||
3301|180|I|   Drug interactions may change how your medications work or||
3301|181|I|increase your risk for serious side effects. This document does||
3301|182|I|not contain all possible drug interactions. Keep a list of all||
3301|183|I|the products you use (including prescription/nonprescription||
3301|184|I|drugs and herbal products) and share it with your doctor and||
3301|185|I|pharmacist. Do not start, stop, or change the dosage of any||
3301|186|I|medicines without your doctor's approval.||
3301|187|I|   Some products that may interact with this drug include: other||
3301|188|I|drugs that weaken the immune system/increase the risk of||
3301|189|I|infection (such as natalizumab, rituximab).||
3301|190|I|   This medication may decrease the effectiveness of hormonal||
3301|191|I|birth control such as pills, patch, or ring. This could cause||
3301|192|I|pregnancy. Discuss with your doctor or pharmacist about using a||
3301|193|I|reliable backup birth control method while using this medication.||
3301|194|I|Also tell your doctor if you have any new spotting or||
3301|195|I|breakthrough bleeding, because these may be signs that your birth||
3301|196|I|control is not working well.||
3301|197|B|||
3301|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3301|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3301|200|O|poison control center right away. US residents can call||
3301|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3301|202|B|||
3301|203|N|NOTES:  Do not share this medication with others.||
3301|204|N|   Lab and/or medical tests (such as blood counts, drug levels,||
3301|205|N|kidney function, pregnancy test) should be done while you are||
3301|206|N|taking this medication. Keep all medical and lab appointments.||
3301|207|N|Consult your doctor for more details.||
3301|208|N|   Attend a transplant education class or support group. Learn to||
3301|209|N|recognize the signs and symptoms of organ rejection and tell your||
3301|210|N|doctor right away if they occur.||
3301|211|B|||
3301|212|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3301|213|D|remember. If it is near the time of the next dose, skip the||
3301|214|D|missed dose. Take your next dose at the regular time. Do not||
3301|215|D|double the dose to catch up.||
3301|216|B|||
3301|217|R|STORAGE:  Different brands of this medication have different||
3301|218|R|storage needs. Check the product package for instructions on how||
3301|219|R|to store your brand, or ask your pharmacist. Once the bottle is||
3301|220|R|opened, this medication expires after 60 days. Keep all||
3301|221|R|medications away from children and pets.||
3301|222|R|   Do not flush medications down the toilet or pour them into a||
3301|223|R|drain unless instructed to do so. Properly discard this product||
3301|224|R|when it is expired or no longer needed. Consult your pharmacist||
3301|225|R|or local waste disposal company.||
3301|226|B|||
3301|227|M|MEDICAL ALERT:  Your condition can cause complications in a||
3301|228|M|medical emergency. For information about enrolling in MedicAlert,||
3301|229|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3301|230|B|||
3301|231|A|Information last revised May 2025.||
3301|232|A|Copyright(c) 2025 First Databank, Inc.||
3301|233|B|||
3303|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3303|002|Z|does NOT have all possible information about this product. This||
3303|003|Z|information does not assure that this product is safe, effective,||
3303|004|Z|or appropriate for you. This information is not individual||
3303|005|Z|medical advice and does not substitute for the advice of your||
3303|006|Z|health care professional. Always ask your health care||
3303|007|Z|professional for complete information about this product and your||
3303|008|Z|specific health needs.||
3303|009|B|||
3303|010|T|ANTI-THYMOCYTE GLOBULIN (RABBIT) - INJECTION||
3303|011|F|(AN-ti THIGH-mow-site GLOB-ue-lin)||
3303|012|B|||
3303|013|C|COMMON BRAND NAME(S): Thymoglobulin||
3303|014|B|||
3303|015|U|USES:  This medication is used to prevent and treat rejection of||
3303|016|U|a kidney transplant. This medication belongs to a class of drugs||
3303|017|U|known as immunosuppressants. It works by decreasing your body's||
3303|018|U|natural defense (immune system). This helps prevent your body||
3303|019|U|from rejecting the kidney transplant so it can work normally.||
3303|020|B|||
3303|021|V|OTHER USES:  This section contains uses of this drug that are not||
3303|022|V|listed in the approved professional labeling for the drug but||
3303|023|V|that may be prescribed by your health care professional. Use this||
3303|024|V|drug for a condition that is listed in this section only if it||
3303|025|V|has been so prescribed by your health care professional.||
3303|026|V|   This drug may also be used for certain blood disorders||
3303|027|V|(aplastic anemia, myelodysplastic syndrome).||
3303|028|B|||
3303|029|H|HOW TO USE:  Before receiving this medication, you may be||
3303|030|H|directed to take other medicines (such as acetaminophen,||
3303|031|H|antibiotic, antihistamine, corticosteroid) to decrease side||
3303|032|H|effects during your treatment.||
3303|033|H|   This medication is given by a health care professional as||
3303|034|H|directed by your doctor. The dosage is based on your weight,||
3303|035|H|medical condition, lab tests, and response to treatment. It is||
3303|036|H|slowly injected into a vein, usually over at least 4 to 6 hours.||
3303|037|H|Tell your doctor or nurse right away if you notice redness, pain,||
3303|038|H|or swelling during your injection.||
3303|039|H|   Follow your doctor's directions for taking your other||
3303|040|H|medications to help prevent your body from rejecting the kidney||
3303|041|H|transplant or to prevent infection. Ask your doctor or pharmacist||
3303|042|H|if you are not sure how to take any of your medicines.||
3303|043|B|||
3303|044|S|SIDE EFFECTS:  Nausea, fever, chills, diarrhea, dizziness,||
3303|045|S|headache, or tiredness may occur. Redness, pain, or swelling at||
3303|046|S|the injection site may also occur. If any of these effects last||
3303|047|S|or get worse, tell your doctor promptly.||
3303|048|S|   People using this medication may have serious side effects.||
3303|049|S|However, you have been prescribed this drug because your doctor||
3303|050|S|has judged that the benefit to you is greater than the risk of||
3303|051|S|side effects. Careful monitoring by your doctor may decrease your||
3303|052|S|risk.||
3303|053|S|   Tell your doctor right away if you have any serious side||
3303|054|S|effects, including: easy bruising/bleeding, fast/irregular||
3303|055|S|heartbeat, joint/muscle pain, severe stomach/abdominal pain,||
3303|056|S|weakness.||
3303|057|S|   Because this drug works by weakening the immune system, it may||
3303|058|S|lower your ability to fight infections. This may make you more||
3303|059|S|likely to get a serious (rarely fatal) infection or make any||
3303|060|S|infection you have worse. Tell your doctor right away if you have||
3303|061|S|any signs of infection (such as sore throat that doesn't go away,||
3303|062|S|fever, chills, pain when urinating).||
3303|063|S|   This medication may increase the risk of developing certain||
3303|064|S|types of cancer. Consult your doctor for details.||
3303|065|S|   A very serious allergic reaction to this drug is rare.||
3303|066|S|However, get medical help right away if you notice any symptoms||
3303|067|S|of a serious allergic reaction, including: rash, itching/swelling||
3303|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3303|069|S|breathing.||
3303|070|S|   This is not a complete list of possible side effects. If you||
3303|071|S|notice other effects not listed above, contact your doctor or||
3303|072|S|pharmacist.||
3303|073|S|   In the US -||
3303|074|S|   Call your doctor for medical advice about side effects. You||
3303|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3303|076|S|www.fda.gov/medwatch.||
3303|077|S|   In Canada - Call your doctor for medical advice about side||
3303|078|S|effects. You may report side effects to Health Canada at||
3303|079|S|1-866-234-2345.||
3303|080|B|||
3303|081|P|PRECAUTIONS:  Before receiving this medication, tell your doctor||
3303|082|P|or pharmacist if you are allergic to it; or to rabbit proteins;||
3303|083|P|or if you have had a severe reaction to other immune globulins;||
3303|084|P|or if you have any other allergies. This product may contain||
3303|085|P|inactive ingredients, which can cause allergic reactions or other||
3303|086|P|problems. Talk to your pharmacist for more details.||
3303|087|P|   Tell your doctor your medical history, especially of:||
3303|088|P|bleeding/blood clotting problems, recent/current infections.||
3303|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3303|090|P|can make you more dizzy. Do not drive, use machinery, or do||
3303|091|P|anything that needs alertness until you can do it safely. Limit||
3303|092|P|alcoholic beverages. Talk to your doctor if you are using||
3303|093|P|marijuana (cannabis).||
3303|094|P|   This medication can make you more likely to get infections or||
3303|095|P|may make current infections worse. Stay away from anyone who has||
3303|096|P|an infection that may easily spread (such as chickenpox,||
3303|097|P|COVID-19, measles, flu). Talk to your doctor if you have been||
3303|098|P|exposed to an infection or for more details.||
3303|099|P|   Tell your health care professional that you are using this||
3303|100|P|medication before having any immunizations/vaccinations. Avoid||
3303|101|P|contact with people who have recently received live vaccines||
3303|102|P|(such as flu vaccine inhaled through the nose).||
3303|103|P|   To lower the chance of getting cut, bruised, or injured, use||
3303|104|P|caution with sharp objects like razors and nail cutters, and||
3303|105|P|avoid activities such as contact sports.||
3303|106|P|   This medication may increase your risk of developing skin||
3303|107|P|cancer. Limit your time in the sun. Avoid tanning booths and||
3303|108|P|sunlamps. Use sunscreen and wear protective clothing when||
3303|109|P|outdoors. Your doctor may direct you to avoid phototherapy while||
3303|110|P|you use this product. Ask your doctor for details.||
3303|111|P|   Before having surgery, tell your doctor or dentist about all||
3303|112|P|the products you use (including prescription drugs,||
3303|113|P|nonprescription drugs, and herbal products).||
3303|114|P|   During pregnancy, this medication should be used only when||
3303|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
3303|116|P|   It is unknown if this drug passes into breast milk. Consult||
3303|117|P|your doctor before breastfeeding.||
3303|118|B|||
3303|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3303|120|I|medications work or increase your risk for serious side effects.||
3303|121|I|This document does not contain all possible drug interactions.||
3303|122|I|Keep a list of all the products you use (including||
3303|123|I|prescription/nonprescription drugs and herbal products) and share||
3303|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
3303|125|I|the dosage of any medicines without your doctor's approval.||
3303|126|I|   Some products that may interact with this drug include: other||
3303|127|I|drugs that weaken the immune system (such as azathioprine,||
3303|128|I|cyclosporine, cancer chemotherapy).||
3303|129|I|   This medication may interfere with certain lab tests, possibly||
3303|130|I|causing false test results. Make sure lab personnel and all your||
3303|131|I|doctors know you use this drug.||
3303|132|B|||
3303|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3303|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3303|135|O|poison control center right away. US residents can call||
3303|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3303|137|B|||
3303|138|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
3303|139|N|should be done while you are using this medication. Keep all||
3303|140|N|medical and lab appointments. Consult your doctor for more||
3303|141|N|details.||
3303|142|B|||
3303|143|D|MISSED DOSE:  It is important to get each dose of this medication||
3303|144|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
3303|145|D|right away for a new dosing schedule.||
3303|146|B|||
3303|147|R|STORAGE:  Not applicable. This medication is given in a hospital||
3303|148|R|or clinic and will not be stored at home.||
3303|149|B|||
3303|150|M|MEDICAL ALERT:  Your condition can cause complications in a||
3303|151|M|medical emergency. For information about enrolling in MedicAlert,||
3303|152|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3303|153|B|||
3303|154|A|Information last revised May 2025.||
3303|155|A|Copyright(c) 2025 First Databank, Inc.||
3303|156|B|||
3309|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3309|002|Z|does NOT have all possible information about this product. This||
3309|003|Z|information does not assure that this product is safe, effective,||
3309|004|Z|or appropriate for you. This information is not individual||
3309|005|Z|medical advice and does not substitute for the advice of your||
3309|006|Z|health care professional. Always ask your health care||
3309|007|Z|professional for complete information about this product and your||
3309|008|Z|specific health needs.||
3309|009|B|||
3309|010|T|METFORMIN SOLUTION - ORAL||
3309|011|F|(met-FOR-min)||
3309|012|B|||
3309|013|C|COMMON BRAND NAME(S): Riomet||
3309|014|B|||
3309|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
3309|016|W|cause a serious (sometimes fatal) condition called lactic||
3309|017|W|acidosis. Lactic acidosis is more likely if you are an older||
3309|018|W|adult, if you have kidney or liver disease, dehydration, heart||
3309|019|W|failure, heavy alcohol use, if you have surgery, if you have||
3309|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
3309|021|W|you are using certain drugs. For some conditions, your doctor may||
3309|022|W|tell you to stop taking this medication for a short time. Ask||
3309|023|W|your doctor or pharmacist for more details.||
3309|024|W|   Stop taking this medication and get medical help right away if||
3309|025|W|you have any symptoms of lactic acidosis, such as unusual||
3309|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
3309|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
3309|028|W|or stomach pain with nausea/vomiting/diarrhea.||
3309|029|B|||
3309|030|U|USES:  Metformin is used with a proper diet and exercise program||
3309|031|U|and possibly with other medications to control high blood sugar.||
3309|032|U|It is used in patients with type 2 diabetes. Controlling high||
3309|033|U|blood sugar helps prevent kidney damage, blindness, nerve||
3309|034|U|problems, loss of limbs, and sexual function problems. Proper||
3309|035|U|control of diabetes may also lessen your risk of a heart attack||
3309|036|U|or stroke. Metformin works by helping to restore your body's||
3309|037|U|proper response to the insulin you naturally produce. It also||
3309|038|U|decreases the amount of sugar that your liver makes and that your||
3309|039|U|stomach/intestines absorb.||
3309|040|B|||
3309|041|V|OTHER USES:  This section contains uses of this drug that are not||
3309|042|V|listed in the approved professional labeling for the drug but||
3309|043|V|that may be prescribed by your health care professional. Use this||
3309|044|V|drug for a condition that is listed in this section only if it||
3309|045|V|has been so prescribed by your health care professional.||
3309|046|V|   This drug may also be used with lifestyle changes such as diet||
3309|047|V|and exercise to keep people who are at high risk for diabetes||
3309|048|V|from becoming diabetic. It may also be used by women with a||
3309|049|V|certain disease of the ovaries (polycystic ovarian syndrome).||
3309|050|V|Metformin may make menstrual cycles more regular and increase||
3309|051|V|fertility.||
3309|052|B|||
3309|053|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3309|054|H|from your pharmacist before you start taking metformin and each||
3309|055|H|time you get a refill. If you have any questions, consult your||
3309|056|H|doctor or pharmacist.||
3309|057|H|   Take this medication by mouth as directed by your doctor,||
3309|058|H|usually 1 to 3 times a day with meals. Drink plenty of fluids||
3309|059|H|while taking this medication unless otherwise directed by your||
3309|060|H|doctor.||
3309|061|H|   Carefully measure your dose with a special measuring||
3309|062|H|device/spoon. Do not use a household spoon because you may not||
3309|063|H|get the correct dose.||
3309|064|H|   The dosage is based on your medical condition, response to||
3309|065|H|treatment, and other medications you may be taking. Be sure to||
3309|066|H|tell your doctor and pharmacist about all the products you use||
3309|067|H|(including prescription drugs, nonprescription drugs, and herbal||
3309|068|H|products). To reduce your risk of side effects (such as upset||
3309|069|H|stomach), your doctor may direct you to start this medication at||
3309|070|H|a low dose and gradually increase your dose. Follow your doctor's||
3309|071|H|instructions carefully.||
3309|072|H|   Take this medication regularly in order to get the most||
3309|073|H|benefit from it. Remember to use it at the same times each day.||
3309|074|H|   Tell your doctor if your condition does not get better or if||
3309|075|H|it gets worse (your blood sugar is too high or too low).||
3309|076|B|||
3309|077|S|SIDE EFFECTS:  See also Warning section.||
3309|078|S|   Nausea, vomiting, stomach upset, diarrhea, weakness, or a||
3309|079|S|metallic taste in the mouth may occur. If any of these effects||
3309|080|S|last or get worse, tell your doctor or pharmacist promptly. If||
3309|081|S|stomach symptoms return later (after taking the same dose for||
3309|082|S|several days or weeks), tell your doctor right away. Stomach||
3309|083|S|symptoms that occur after the first days of your treatment may be||
3309|084|S|signs of lactic acidosis.||
3309|085|S|   Remember that this medication has been prescribed because your||
3309|086|S|doctor has judged that the benefit to you is greater than the||
3309|087|S|risk of side effects. Many people using this medication do not||
3309|088|S|have serious side effects.||
3309|089|S|   Metformin does not usually cause low blood sugar||
3309|090|S|(hypoglycemia). Low blood sugar may occur if this drug is||
3309|091|S|prescribed with other diabetes medications, or if you do not get||
3309|092|S|enough calories from food, or if you do unusually heavy exercise.||
3309|093|S|Talk with your doctor or pharmacist about whether the dose of||
3309|094|S|your other diabetes medication(s) needs to be lowered. Symptoms||
3309|095|S|of low blood sugar include sudden sweating, shaking, fast||
3309|096|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
3309|097|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
3309|098|S|treat low blood sugar. If you don't have these reliable forms of||
3309|099|S|glucose, rapidly raise your blood sugar by eating a quick source||
3309|100|S|of sugar such as table sugar, honey, or candy, or drink fruit||
3309|101|S|juice or non-diet soda. Tell your doctor right away about the||
3309|102|S|reaction and the use of this product. To help prevent low blood||
3309|103|S|sugar, eat meals on a regular schedule, and do not skip meals.||
3309|104|S|Check with your doctor or pharmacist to find out what you should||
3309|105|S|do if you miss a meal.||
3309|106|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
3309|107|S|thirst/urination. If these symptoms occur, tell your doctor right||
3309|108|S|away. Your doctor may need to adjust your diabetes medication,||
3309|109|S|exercise program, or diet.||
3309|110|S|   Stop taking this medication and tell your doctor right away if||
3309|111|S|this very serious side effect occurs: lactic acidosis (see||
3309|112|S|Warning section).||
3309|113|S|   A very serious allergic reaction to this drug is rare.||
3309|114|S|However, get medical help right away if you notice any symptoms||
3309|115|S|of a serious allergic reaction, including: rash, itching/swelling||
3309|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3309|117|S|breathing.||
3309|118|S|   This is not a complete list of possible side effects. If you||
3309|119|S|notice other effects not listed above, contact your doctor or||
3309|120|S|pharmacist.||
3309|121|S|   In the US -||
3309|122|S|   Call your doctor for medical advice about side effects. You||
3309|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3309|124|S|www.fda.gov/medwatch.||
3309|125|S|   In Canada - Call your doctor for medical advice about side||
3309|126|S|effects. You may report side effects to Health Canada at||
3309|127|S|1-866-234-2345.||
3309|128|B|||
3309|129|P|PRECAUTIONS:  See also Warning section.||
3309|130|P|   Before taking this medication, tell your doctor or pharmacist||
3309|131|P|if you are allergic to metformin; or if you have any other||
3309|132|P|allergies. This product may contain inactive ingredients, which||
3309|133|P|can cause allergic reactions or other problems. Talk to your||
3309|134|P|pharmacist for more details.||
3309|135|P|   Before using this medication, tell your doctor or pharmacist||
3309|136|P|your medical history, especially of: severe breathing problems||
3309|137|P|(such as obstructive lung disease, severe asthma), blood problems||
3309|138|P|(such as anemia, vitamin B12 deficiency), kidney disease, liver||
3309|139|P|disease.||
3309|140|P|   Before having surgery or any X-ray/scanning procedure using||
3309|141|P|iodinated contrast, tell your doctor or dentist about all the||
3309|142|P|products you use (including prescription drugs, nonprescription||
3309|143|P|drugs, and herbal products). You may need to stop this medication||
3309|144|P|for a short time for the surgery/procedure. Ask your doctor or||
3309|145|P|dentist for instructions before your surgery/procedure.||
3309|146|P|   You may experience blurred vision, dizziness, or drowsiness||
3309|147|P|due to extremely low or high blood sugar. Do not drive, use||
3309|148|P|machinery, or do anything that needs alertness or clear vision||
3309|149|P|until you can do it safely.||
3309|150|P|   Limit alcohol while using this medication because it can||
3309|151|P|increase your risk of lactic acidosis and developing low blood||
3309|152|P|sugar.||
3309|153|P|   High fever, "water pills" (diuretics such as||
3309|154|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
3309|155|P|may cause dehydration and increase your risk of lactic acidosis.||
3309|156|P|Stop taking this medication and tell your doctor right away if||
3309|157|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
3309|158|P|fluids to prevent dehydration unless your doctor directs you||
3309|159|P|otherwise.||
3309|160|P|   It may be harder to control your blood sugar when your body is||
3309|161|P|stressed (such as due to fever, infection, injury, or surgery).||
3309|162|P|Consult your doctor because increased stress may require a change||
3309|163|P|in your treatment plan, medications, or blood sugar testing.||
3309|164|P|   Older adults may be at greater risk for side effects such as||
3309|165|P|low blood sugar or lactic acidosis.||
3309|166|P|   During pregnancy, this medication should be used only when||
3309|167|P|clearly needed. Discuss the risks and benefits with your doctor.||
3309|168|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
3309|169|P|your doctor for managing your blood sugar while pregnant. Your||
3309|170|P|doctor may change your diabetes treatment during your pregnancy||
3309|171|P|(such as diet and medications including insulin).||
3309|172|P|   Metformin can cause changes in the menstrual cycle (promote||
3309|173|P|ovulation) and increase the risk of becoming pregnant. Consult||
3309|174|P|your doctor or pharmacist about the use of reliable birth control||
3309|175|P|while using this medication.||
3309|176|P|   Metformin passes into breast milk in small amounts. Consult||
3309|177|P|your doctor before breastfeeding.||
3309|178|B|||
3309|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3309|180|I|medications work or increase your risk for serious side effects.||
3309|181|I|This document does not contain all possible drug interactions.||
3309|182|I|Keep a list of all the products you use (including||
3309|183|I|prescription/nonprescription drugs and herbal products) and share||
3309|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
3309|185|I|the dosage of any medicines without your doctor's approval.||
3309|186|I|   Beta-blocker medications (such as metoprolol, propranolol,||
3309|187|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
3309|188|I|heartbeat you would usually feel when your blood sugar falls too||
3309|189|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
3309|190|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
3309|191|I|   Many drugs can affect your blood sugar, making it harder to||
3309|192|I|control. Before you start, stop, or change any medication, talk||
3309|193|I|with your doctor or pharmacist about how the medication may||
3309|194|I|affect your blood sugar. Check your blood sugar regularly as||
3309|195|I|directed and share the results with your doctor. Tell your doctor||
3309|196|I|right away if you have symptoms of high or low blood sugar. (See||
3309|197|I|also Side Effects section.) Your doctor may need to adjust your||
3309|198|I|diabetes medication, exercise program, or diet.||
3309|199|B|||
3309|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3309|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3309|202|O|poison control center right away. US residents can call||
3309|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3309|204|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
3309|205|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
3309|206|O|rapid breathing, slow/irregular heartbeat.||
3309|207|B|||
3309|208|N|NOTES:  Do not share this medication with others.||
3309|209|N|   Attend a diabetes education program to learn more about how to||
3309|210|N|manage your diabetes with medications, diet, exercise, and||
3309|211|N|regular medical exams.||
3309|212|N|   Learn the symptoms of high and low blood sugar and how to||
3309|213|N|treat low blood sugar. Check your blood sugar regularly as||
3309|214|N|directed and share the results with your doctor.||
3309|215|N|   Lab and/or medical tests (such as kidney function, liver||
3309|216|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
3309|217|N|should be done before you start taking this medication and while||
3309|218|N|you are taking it. Keep all medical and lab appointments. Consult||
3309|219|N|your doctor for more details.||
3309|220|B|||
3309|221|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3309|222|D|remember. If it is near the time of the next dose, skip the||
3309|223|D|missed dose. Take your next dose at the regular time. Do not||
3309|224|D|double the dose to catch up.||
3309|225|B|||
3309|226|R|STORAGE:  Store at room temperature. Keep all medications away||
3309|227|R|from children and pets.||
3309|228|R|   Do not flush medications down the toilet or pour them into a||
3309|229|R|drain unless instructed to do so. Properly discard this product||
3309|230|R|when it is expired or no longer needed. Consult your pharmacist||
3309|231|R|or local waste disposal company.||
3309|232|B|||
3309|233|M|MEDICAL ALERT:  Your condition can cause complications in a||
3309|234|M|medical emergency. For information about enrolling in MedicAlert,||
3309|235|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3309|236|B|||
3309|237|A|Information last revised November 2025.||
3309|238|A|Copyright(c) 2025 First Databank, Inc.||
3309|239|B|||
3311|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3311|002|Z|does NOT have all possible information about this product. This||
3311|003|Z|information does not assure that this product is safe, effective,||
3311|004|Z|or appropriate for you. This information is not individual||
3311|005|Z|medical advice and does not substitute for the advice of your||
3311|006|Z|health care professional. Always ask your health care||
3311|007|Z|professional for complete information about this product and your||
3311|008|Z|specific health needs.||
3311|009|B|||
3311|010|T|HORSE CHESTNUT (Aesculus hippocastanum) - ORAL||
3311|011|B|||
3311|012|U|USES:  Horse chestnut has been used for swelling and pain due to||
3311|013|U|varicose veins and poor circulation in the legs.||
3311|014|U|   Some herbal/dietary supplement products have been found to||
3311|015|U|contain possibly harmful impurities/additives. Check with your||
3311|016|U|pharmacist for more details about the brand you use.||
3311|017|U|   The FDA has not reviewed this product for safety or||
3311|018|U|effectiveness. Consult your doctor or pharmacist for more||
3311|019|U|details.||
3311|020|B|||
3311|021|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
3311|022|H|directions on the product package. Check the label carefully to||
3311|023|H|make sure you have the correct product. Horse chestnut seed||
3311|024|H|extract is different than whole horse chestnut seeds. Do not take||
3311|025|H|the raw seeds, bark, flowers, or leaves of horse chestnut by||
3311|026|H|mouth because these products are poisonous. Use only standardized||
3311|027|H|horse chestnut seed extract products that have had the toxin||
3311|028|H|removed. If you have any questions, ask your doctor or||
3311|029|H|pharmacist.||
3311|030|H|   This herbal product should only be used short-term. It should||
3311|031|H|not be used for more than 3 months.||
3311|032|H|   If your condition lasts or gets worse, or if you think you may||
3311|033|H|have a serious medical problem, get medical help right away.||
3311|034|B|||
3311|035|S|SIDE EFFECTS:  Upset stomach, headache, and dizziness may occur.||
3311|036|S|If any of these effects last or get worse, tell your doctor or||
3311|037|S|pharmacist promptly.||
3311|038|S|   This product may cause your urine to turn red. This is||
3311|039|S|harmless.||
3311|040|S|   Tell your doctor right away if you have any serious side||
3311|041|S|effects, including: easy or unusual bleeding/bruising.||
3311|042|S|   A very serious allergic reaction to this product is rare.||
3311|043|S|However, get medical help right away if you notice any symptoms||
3311|044|S|of a serious allergic reaction, including: rash, itching/swelling||
3311|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3311|046|S|breathing.||
3311|047|S|   This is not a complete list of possible side effects. If you||
3311|048|S|notice other effects not listed above, contact your doctor or||
3311|049|S|pharmacist.||
3311|050|S|   In the US -||
3311|051|S|   Call your doctor for medical advice about side effects. You||
3311|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3311|053|S|www.fda.gov/medwatch.||
3311|054|S|   In Canada - Call your doctor for medical advice about side||
3311|055|S|effects. You may report side effects to Health Canada at||
3311|056|S|1-866-234-2345.||
3311|057|B|||
3311|058|P|PRECAUTIONS:  Before taking horse chestnut, tell your doctor or||
3311|059|P|pharmacist if you are allergic to it; or if you have any other||
3311|060|P|allergies. People allergic to latex should not take horse||
3311|061|P|chestnut because they may be at greater risk of having an||
3311|062|P|allergic reaction to it. This product may contain inactive||
3311|063|P|ingredients, which can cause allergic reactions or other||
3311|064|P|problems. Talk to your pharmacist for more details.||
3311|065|P|   If you have any of the following health problems, consult your||
3311|066|P|doctor or pharmacist before using this product: bleeding or||
3311|067|P|clotting problems, kidney problems, liver problems,||
3311|068|P|stomach/intestinal problems (such as infection/inflammatory||
3311|069|P|disease of the gut).||
3311|070|P|   This product may make you dizzy. Alcohol or marijuana||
3311|071|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
3311|072|P|or do anything that needs alertness until you can do it safely.||
3311|073|P|Limit alcoholic beverages. Talk to your doctor if you are using||
3311|074|P|marijuana (cannabis).||
3311|075|P|   Liquid products may contain sugar and/or alcohol. Caution is||
3311|076|P|advised if you have diabetes, alcohol dependence, or liver||
3311|077|P|disease. Ask your doctor or pharmacist about using this product||
3311|078|P|safely.||
3311|079|P|   This product is not recommended for use during pregnancy.||
3311|080|P|Consult your doctor before using this product.||
3311|081|P|   It is unknown if this product passes into breast milk. Consult||
3311|082|P|your doctor before breastfeeding.||
3311|083|B|||
3311|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3311|085|I|medications work or increase your risk for serious side effects.||
3311|086|I|This document does not contain all possible drug interactions.||
3311|087|I|Keep a list of all the products you use (including||
3311|088|I|prescription/nonprescription drugs and herbal products) and share||
3311|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
3311|090|I|the dosage of any medicines without your doctor's approval.||
3311|091|I|   Some drugs that may interact with this product include: "blood||
3311|092|I|thinners" (such as warfarin, heparin), anti-platelet drugs (such||
3311|093|I|as clopidogrel), nonsteroidal anti-inflammatory drugs (NSAIDs||
3311|094|I|such as ibuprofen, naproxen), herbal products that may increase||
3311|095|I|the risk of bleeding (such as danshen, garlic, ginseng).||
3311|096|I|   Aspirin may also increase the risk of bleeding when used with||
3311|097|I|this product. If your doctor has told you to take low-dose||
3311|098|I|aspirin to prevent heart attack or stroke (usually 81-162||
3311|099|I|milligrams a day), you should keep taking the aspirin unless your||
3311|100|I|doctor tells you not to. Ask your doctor or pharmacist for more||
3311|101|I|details.||
3311|102|B|||
3311|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3311|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3311|105|O|poison control center right away. US residents can call||
3311|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3311|107|B|||
3311|108|N|NOTES:  Keep all medical and lab appointments.||
3311|109|B|||
3311|110|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3311|111|D|remember. If it is near the time of the next dose, skip the||
3311|112|D|missed dose. Take your next dose at the regular time. Do not||
3311|113|D|double the dose to catch up.||
3311|114|B|||
3311|115|R|STORAGE:  Refer to storage information printed on the package. If||
3311|116|R|you have any questions about storage, ask your pharmacist. Keep||
3311|117|R|all medications and herbal products away from children and pets.||
3311|118|R|   Do not flush medications down the toilet or pour them into a||
3311|119|R|drain unless instructed to do so. Properly discard this product||
3311|120|R|when it is expired or no longer needed. Consult your pharmacist||
3311|121|R|or local waste disposal company.||
3311|122|B|||
3311|123|A|Information last revised May 2025.||
3311|124|A|Copyright(c) 2025 First Databank, Inc.||
3311|125|B|||
3312|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3312|002|Z|does NOT have all possible information about this product. This||
3312|003|Z|information does not assure that this product is safe, effective,||
3312|004|Z|or appropriate for you. This information is not individual||
3312|005|Z|medical advice and does not substitute for the advice of your||
3312|006|Z|health care professional. Always ask your health care||
3312|007|Z|professional for complete information about this product and your||
3312|008|Z|specific health needs.||
3312|009|B|||
3312|010|T|GREEN TEA (Camellia sinensis) - ORAL||
3312|011|B|||
3312|012|U|USES:  Green tea contains caffeine and it has been used to||
3312|013|U|increase alertness. Green tea has also been used to reduce the||
3312|014|U|risk of cancer, to lower cholesterol, and to reduce the risk or||
3312|015|U|delay Parkinson's disease.||
3312|016|U|   Some herbal/diet supplement products have been found to||
3312|017|U|contain possibly harmful impurities/additives. Check with your||
3312|018|U|pharmacist for more details regarding the particular brand you||
3312|019|U|use.||
3312|020|U|   The FDA has not reviewed this product for safety or||
3312|021|U|effectiveness. Consult your doctor or pharmacist for more||
3312|022|U|details.||
3312|023|B|||
3312|024|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
3312|025|H|directions on the product package. If you have any questions, ask||
3312|026|H|your doctor or pharmacist.||
3312|027|H|   If you suddenly stop using this medication, you may have||
3312|028|H|withdrawal symptoms (such as headache, mental/mood changes such||
3312|029|H|as irritability/nervousness). To help prevent withdrawal, your||
3312|030|H|doctor may lower your dose slowly. Withdrawal is more likely if||
3312|031|H|you have used green tea for a long time or in high doses. Tell||
3312|032|H|your doctor or pharmacist right away if you have withdrawal.||
3312|033|H|   This product can decrease the amount of iron you get from||
3312|034|H|food/supplements. If you have low iron levels, do not take green||
3312|035|H|tea with meals or iron supplements. Take this product between||
3312|036|H|meals.||
3312|037|H|   This product contains caffeine. Avoid drinking large amounts||
3312|038|H|of beverages containing caffeine (coffee, tea, colas), eating||
3312|039|H|large amounts of chocolate, or taking nonprescription products||
3312|040|H|that contain caffeine.||
3312|041|H|   If your condition lasts or gets worse, or if you think you may||
3312|042|H|have a serious medical problem, get medical help right away.||
3312|043|B|||
3312|044|S|SIDE EFFECTS:  Nausea, diarrhea, upset stomach, headache, and||
3312|045|S|dizziness may occur. If any of these effects last or get worse,||
3312|046|S|contact your doctor promptly.||
3312|047|S|   Tell your doctor right away if you have any serious side||
3312|048|S|effects, including: fast/irregular heartbeat, mental/mood changes||
3312|049|S|(such as nervousness, confusion), trouble sleeping, restlessness,||
3312|050|S|shakiness (tremor), seizures, signs of liver problems (such as||
3312|051|S|nausea/vomiting that doesn't stop, loss of appetite,||
3312|052|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
3312|053|S|   A very serious allergic reaction to this product is rare.||
3312|054|S|However, get medical help right away if you notice any symptoms||
3312|055|S|of a serious allergic reaction, including: rash, itching/swelling||
3312|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3312|057|S|breathing.||
3312|058|S|   This is not a complete list of possible side effects. If you||
3312|059|S|notice other effects not listed above, contact your doctor or||
3312|060|S|pharmacist.||
3312|061|S|   In the US -||
3312|062|S|   Call your doctor for medical advice about side effects. You||
3312|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3312|064|S|www.fda.gov/medwatch.||
3312|065|S|   In Canada - Call your doctor for medical advice about side||
3312|066|S|effects. You may report side effects to Health Canada at||
3312|067|S|1-866-234-2345.||
3312|068|B|||
3312|069|P|PRECAUTIONS:  Before taking green tea, tell your doctor or||
3312|070|P|pharmacist if you are allergic to it; or if you have any other||
3312|071|P|allergies. This product may contain inactive ingredients, which||
3312|072|P|can cause allergic reactions or other problems. Talk to your||
3312|073|P|pharmacist for more details.||
3312|074|P|   If you have any of the following health problems, consult your||
3312|075|P|doctor or pharmacist before using this product: anemia (iron||
3312|076|P|deficiency anemia), bleeding problems, diabetes, a certain eye||
3312|077|P|condition (glaucoma), heart problems (such as irregular||
3312|078|P|heartbeat, recent heart attack), stomach/intestinal problems||
3312|079|P|(such as ulcers, reflux disease-GERD), liver problems,||
3312|080|P|mental/mood disorder (such as anxiety, panic attacks), low levels||
3312|081|P|of calcium in the blood, bone problems such as osteoporosis.||
3312|082|P|   Liquid preparations of this product may contain sugar and/or||
3312|083|P|alcohol. Caution is advised if you have diabetes, alcohol||
3312|084|P|dependence, or liver disease. Ask your doctor or pharmacist about||
3312|085|P|using this product safely.||
3312|086|P|   Children may be more sensitive to the side effects of this||
3312|087|P|product, especially the effects of caffeine in this product.||
3312|088|P|   During pregnancy, consult your doctor before using this||
3312|089|P|product. Green tea contains caffeine. It is recommended that||
3312|090|P|women limit caffeine during pregnancy. This product may also||
3312|091|P|decrease folic acid. Discuss the risks and benefits with your||
3312|092|P|doctor.||
3312|093|P|   This product may pass into breast milk and have undesirable||
3312|094|P|effects on a nursing infant. Consult your doctor before||
3312|095|P|breastfeeding.||
3312|096|B|||
3312|097|I|DRUG INTERACTIONS:  See also How to Use section.||
3312|098|I|   Drug interactions may change how your medications work or||
3312|099|I|increase your risk for serious side effects. This document does||
3312|100|I|not contain all possible drug interactions. Keep a list of all||
3312|101|I|the products you use (including prescription/nonprescription||
3312|102|I|drugs and herbal products) and share it with your doctor and||
3312|103|I|pharmacist. Do not start, stop, or change the dosage of any||
3312|104|I|medicines without your doctor's approval.||
3312|105|I|   Some drugs that may interact with this product are: "blood||
3312|106|I|thinners" (such as warfarin), theophylline.||
3312|107|I|   This product can slow down the removal of other medications||
3312|108|I|from your body, which may affect how they work. An example of an||
3312|109|I|affected drug is fezolinetant, among others.||
3312|110|I|   Check the labels on all your medicines (such as cough-and-cold||
3312|111|I|products, diet aids, headache medicines) because they may contain||
3312|112|I|caffeine or other stimulants (such as ephedra/ma huang,||
3312|113|I|phenylpropanolamine) that could increase your heart rate or blood||
3312|114|I|pressure. Ask your pharmacist about using those products safely.||
3312|115|I|   This product may interfere with certain medical/lab tests||
3312|116|I|(such as chemical stress tests using adenosine/dipyridamole,||
3312|117|I|urine tests for calcium/catecholamines, lung function test),||
3312|118|I|possibly causing false test results. Make sure lab personnel and||
3312|119|I|all your doctors know you use this product.||
3312|120|B|||
3312|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3312|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3312|123|O|poison control center right away. US residents can call||
3312|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3312|125|O|Symptoms of overdose may include: seizures, irregular heartbeat.||
3312|126|B|||
3312|127|N|NOTES:  Keep all medical and lab appointments.||
3312|128|B|||
3312|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3312|130|D|remember. If it is near the time of the next dose, skip the||
3312|131|D|missed dose. Take your next dose at the regular time. Do not||
3312|132|D|double the dose to catch up.||
3312|133|B|||
3312|134|R|STORAGE:  Refer to storage information printed on the package. If||
3312|135|R|you have any questions about storage, ask your pharmacist. Keep||
3312|136|R|all medications and herbal products away from children and pets.||
3312|137|R|   Do not flush medications down the toilet or pour them into a||
3312|138|R|drain unless instructed to do so. Properly discard this product||
3312|139|R|when it is expired or no longer needed. Consult your pharmacist||
3312|140|R|or local waste disposal company.||
3312|141|B|||
3312|142|A|Information last revised September 2025.||
3312|143|A|Copyright(c) 2025 First Databank, Inc.||
3312|144|B|||
3313|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3313|002|Z|does NOT have all possible information about this product. This||
3313|003|Z|information does not assure that this product is safe, effective,||
3313|004|Z|or appropriate for you. This information is not individual||
3313|005|Z|medical advice and does not substitute for the advice of your||
3313|006|Z|health care professional. Always ask your health care||
3313|007|Z|professional for complete information about this product and your||
3313|008|Z|specific health needs.||
3313|009|B|||
3313|010|T|EVENING PRIMROSE OIL - ORAL||
3313|011|B|||
3313|012|U|USES:  Evening primrose oil has been used for breast pain||
3313|013|U|(including breast pain related to the menstrual cycle).||
3313|014|U|   Evening primrose oil has not been shown to be effective for||
3313|015|U|preventing or treating cancer. If you have cancer or think you||
3313|016|U|may have cancer, consult your doctor.||
3313|017|U|   Some herbal/dietary supplement products have been found to||
3313|018|U|contain possibly harmful impurities/additives. Check with your||
3313|019|U|pharmacist for more details about the brand you use.||
3313|020|U|   The FDA has not reviewed this product for safety or||
3313|021|U|effectiveness. Consult your doctor or pharmacist for more||
3313|022|U|details.||
3313|023|B|||
3313|024|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
3313|025|H|directions on the product package. If you have any questions, ask||
3313|026|H|your doctor or pharmacist.||
3313|027|H|   If your condition lasts or gets worse, or if you think you may||
3313|028|H|have a serious medical problem, get medical help right away.||
3313|029|B|||
3313|030|S|SIDE EFFECTS:  Upset stomach, nausea, soft stools, or headache||
3313|031|S|may occur. If any of these effects last or get worse, tell your||
3313|032|S|doctor or pharmacist promptly.||
3313|033|S|   A very serious allergic reaction to this product is rare.||
3313|034|S|However, get medical help right away if you notice any symptoms||
3313|035|S|of a serious allergic reaction, including: rash, itching/swelling||
3313|036|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3313|037|S|breathing.||
3313|038|S|   This is not a complete list of possible side effects. If you||
3313|039|S|notice other effects not listed above, contact your doctor or||
3313|040|S|pharmacist.||
3313|041|S|   In the US -||
3313|042|S|   Call your doctor for medical advice about side effects. You||
3313|043|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3313|044|S|www.fda.gov/medwatch.||
3313|045|S|   In Canada - Call your doctor for medical advice about side||
3313|046|S|effects. You may report side effects to Health Canada at||
3313|047|S|1-866-234-2345.||
3313|048|B|||
3313|049|P|PRECAUTIONS:  Before taking evening primrose oil, tell your||
3313|050|P|doctor or pharmacist if you are allergic to it; or if you have||
3313|051|P|any other allergies. This product may contain inactive||
3313|052|P|ingredients, which can cause allergic reactions or other||
3313|053|P|problems. Talk to your pharmacist for more details.||
3313|054|P|   If you have any of the following health problems, consult your||
3313|055|P|doctor or pharmacist before using this product: bleeding or||
3313|056|P|clotting problems.||
3313|057|P|   Liquid products may contain sugar and/or alcohol. Caution is||
3313|058|P|advised if you have diabetes, alcohol dependence, or liver||
3313|059|P|disease. Ask your doctor or pharmacist about using this product||
3313|060|P|safely.||
3313|061|P|   Before having surgery, tell your doctor or dentist about all||
3313|062|P|the products you use (including prescription drugs,||
3313|063|P|nonprescription drugs, and herbal products).||
3313|064|P|   This product is not recommended for use during pregnancy.||
3313|065|P|Consult your doctor before using this product.||
3313|066|P|   This product passes into breast milk, but is unlikely to harm||
3313|067|P|a nursing infant. Consult your doctor before breastfeeding.||
3313|068|B|||
3313|069|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3313|070|I|medications work or increase your risk for serious side effects.||
3313|071|I|This document does not contain all possible drug interactions.||
3313|072|I|Keep a list of all the products you use (including||
3313|073|I|prescription/nonprescription drugs and herbal products) and share||
3313|074|I|it with your doctor and pharmacist. Do not start, stop, or change||
3313|075|I|the dosage of any medicines without your doctor's approval.||
3313|076|I|   Some products that may interact with this drug are:||
3313|077|I|medications/herbal products that may increase your risk of||
3313|078|I|bleeding (including "blood thinners" such as warfarin and||
3313|079|I|heparin, anti-platelet drugs such as clopidogrel, nonsteroidal||
3313|080|I|anti-inflammatory drugs-NSAIDs such as ibuprofen, herbals such as||
3313|081|I|danshen/garlic/ginger).||
3313|082|I|   Aspirin may also increase the risk of bleeding when used with||
3313|083|I|this product. If your doctor has told you to take low-dose||
3313|084|I|aspirin to prevent heart attack or stroke (usually 81-162||
3313|085|I|milligrams a day), you should keep taking the aspirin unless your||
3313|086|I|doctor tells you not to. Ask your doctor or pharmacist for more||
3313|087|I|details.||
3313|088|I|   This product may interfere with certain lab tests (such as||
3313|089|I|bleeding time, cholesterol levels), possibly causing false test||
3313|090|I|results. Make sure lab personnel and all your doctors know you||
3313|091|I|use this product.||
3313|092|B|||
3313|093|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3313|094|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3313|095|O|poison control center right away. US residents can call||
3313|096|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3313|097|B|||
3313|098|N|NOTES:  Keep all medical and lab appointments.||
3313|099|B|||
3313|100|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3313|101|D|remember. If it is near the time of the next dose, skip the||
3313|102|D|missed dose. Take your next dose at the regular time. Do not||
3313|103|D|double the dose to catch up.||
3313|104|B|||
3313|105|R|STORAGE:  Refer to storage information printed on the package. If||
3313|106|R|you have any questions about storage, ask your pharmacist. Keep||
3313|107|R|all medications and herbal products away from children and pets.||
3313|108|R|   Do not flush medications down the toilet or pour them into a||
3313|109|R|drain unless instructed to do so. Properly discard this product||
3313|110|R|when it is expired or no longer needed. Consult your pharmacist||
3313|111|R|or local waste disposal company.||
3313|112|B|||
3313|113|A|Information last revised February 2025.||
3313|114|A|Copyright(c) 2025 First Databank, Inc.||
3313|115|B|||
3314|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3314|002|Z|does NOT have all possible information about this product. This||
3314|003|Z|information does not assure that this product is safe, effective,||
3314|004|Z|or appropriate for you. This information is not individual||
3314|005|Z|medical advice and does not substitute for the advice of your||
3314|006|Z|health care professional. Always ask your health care||
3314|007|Z|professional for complete information about this product and your||
3314|008|Z|specific health needs.||
3314|009|B|||
3314|010|T|CRANBERRY (Vaccinium macrocarpon) - ORAL||
3314|011|B|||
3314|012|U|USES:  Cranberry has been used for reducing the risk of "bladder||
3314|013|U|infections" (urinary tract infections). It has also been used for||
3314|014|U|decreasing the smell of urine in people who are unable to control||
3314|015|U|urination (incontinent).||
3314|016|U|   This product should not be used alone to treat bladder||
3314|017|U|infections. It may not work, and the delay could allow the||
3314|018|U|infection to worsen.||
3314|019|U|   Some herbal/diet supplement products have been found to||
3314|020|U|contain possibly harmful impurities/additives. Check with your||
3314|021|U|pharmacist for more details about the brand you use.||
3314|022|U|   The FDA has not reviewed this product for safety or||
3314|023|U|effectiveness. Consult your doctor or pharmacist for more||
3314|024|U|details.||
3314|025|B|||
3314|026|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
3314|027|H|directions and warnings on the product package. If you have any||
3314|028|H|questions, ask your doctor or pharmacist.||
3314|029|H|   If you are taking a chewable form of this product, chew||
3314|030|H|thoroughly before swallowing.||
3314|031|H|   Tell your doctor if your condition lasts or gets worse. Also,||
3314|032|H|tell your doctor if you have any symptoms of a urinary||
3314|033|H|tract/bladder infection, including fever or||
3314|034|H|burning/painful/frequent urination. You may need medication (such||
3314|035|H|as antibiotics) to treat your infection. If you think you may||
3314|036|H|have a serious medical problem, get medical help right away.||
3314|037|B|||
3314|038|S|SIDE EFFECTS:  Stomach upset or diarrhea may occur with very||
3314|039|S|large doses. If any of these effects last or get worse, tell your||
3314|040|S|doctor or pharmacist promptly.||
3314|041|S|   Tell your doctor right away if you have any serious side||
3314|042|S|effects, including: severe stomach/abdominal pain.||
3314|043|S|   A very serious allergic reaction to this product is rare.||
3314|044|S|However, get medical help right away if you notice any symptoms||
3314|045|S|of a serious allergic reaction, including: rash, itching/swelling||
3314|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3314|047|S|breathing.||
3314|048|S|   This is not a complete list of possible side effects. If you||
3314|049|S|notice other effects not listed above, contact your doctor or||
3314|050|S|pharmacist.||
3314|051|S|   In the US -||
3314|052|S|   Call your doctor for medical advice about side effects. You||
3314|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3314|054|S|www.fda.gov/medwatch.||
3314|055|S|   In Canada - Call your doctor for medical advice about side||
3314|056|S|effects. You may report side effects to Health Canada at||
3314|057|S|1-866-234-2345.||
3314|058|B|||
3314|059|P|PRECAUTIONS:  Before taking cranberry, tell your doctor or||
3314|060|P|pharmacist if you are allergic to it; or if you have any other||
3314|061|P|allergies. This product may contain inactive ingredients, which||
3314|062|P|can cause allergic reactions or other problems. Talk to your||
3314|063|P|pharmacist for more details.||
3314|064|P|   If you have any of the following health problems, consult your||
3314|065|P|doctor or pharmacist before using this product: current/past||
3314|066|P|kidney stones.||
3314|067|P|   Liquid products and chewable forms of this product may contain||
3314|068|P|sugar. Liquid forms may also contain alcohol. Caution is advised||
3314|069|P|if you have diabetes, liver disease, or any other condition that||
3314|070|P|requires you to limit/avoid these substances in your diet. Ask||
3314|071|P|your doctor or pharmacist about using this product safely.||
3314|072|P|   Before having surgery, tell your doctor or dentist about all||
3314|073|P|the products you use (including prescription drugs,||
3314|074|P|nonprescription drugs, and herbal products).||
3314|075|P|   During pregnancy, this product should be used only when||
3314|076|P|clearly needed. Discuss the risks and benefits with your doctor.||
3314|077|P|   It is unknown if this product passes into breast milk. Consult||
3314|078|P|your doctor before breastfeeding.||
3314|079|B|||
3314|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3314|081|I|medications work or increase your risk for serious side effects.||
3314|082|I|This document does not contain all possible drug interactions.||
3314|083|I|Keep a list of all the products you use (including||
3314|084|I|prescription/nonprescription drugs and herbal products) and share||
3314|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
3314|086|I|the dosage of any medicines without your doctor's approval.||
3314|087|B|||
3314|088|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3314|089|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3314|090|O|poison control center right away. US residents can call||
3314|091|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3314|092|B|||
3314|093|N|NOTES:  Keep all medical and lab appointments.||
3314|094|B|||
3314|095|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3314|096|D|If it is near the time of the next dose, skip the missed dose.||
3314|097|D|Use your next dose at the regular time. Do not double the dose to||
3314|098|D|catch up.||
3314|099|B|||
3314|100|R|STORAGE:  Refer to storage information printed on the package. If||
3314|101|R|you have any questions about storage, ask your pharmacist. Keep||
3314|102|R|all medications and herbal products away from children and pets.||
3314|103|R|   Do not flush medications down the toilet or pour them into a||
3314|104|R|drain unless instructed to do so. Properly discard this product||
3314|105|R|when it is expired or no longer needed. Consult your pharmacist||
3314|106|R|or local waste disposal company.||
3314|107|B|||
3314|108|A|Information last revised May 2024.||
3314|109|A|Copyright(c) 2025 First Databank, Inc.||
3314|110|B|||
3321|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3321|002|Z|does NOT have all possible information about this product. This||
3321|003|Z|information does not assure that this product is safe, effective,||
3321|004|Z|or appropriate for you. This information is not individual||
3321|005|Z|medical advice and does not substitute for the advice of your||
3321|006|Z|health care professional. Always ask your health care||
3321|007|Z|professional for complete information about this product and your||
3321|008|Z|specific health needs.||
3321|009|B|||
3321|010|T|MOXIFLOXACIN - OPHTHALMIC||
3321|011|F|(mox-ih-FLOX-uh-sin)||
3321|012|B|||
3321|013|C|COMMON BRAND NAME(S): Vigamox||
3321|014|B|||
3321|015|U|USES:  This medication is a quinolone antibiotic used for eye||
3321|016|U|infections.||
3321|017|B|||
3321|018|H|HOW TO USE:  Use this medication in the affected eye(s) as||
3321|019|H|directed by your doctor, usually 3 times a day.||
3321|020|H|   To apply eye drops, wash hands first. To avoid contamination,||
3321|021|H|do not touch the dropper tip or let it touch your eye or any||
3321|022|H|other surface.||
3321|023|H|   Do not wear contact lenses while you are using this medicine.||
3321|024|H|Sterilize contact lenses according to manufacturer's directions||
3321|025|H|and check with your doctor before using them again.||
3321|026|H|   Tilt your head back, gaze upward and pull down the lower||
3321|027|H|eyelid to make a pouch. Place the dropper directly over eye and||
3321|028|H|instill the prescribed number of drops. Look downward and gently||
3321|029|H|close your eye for 1 to 2 minutes. Place one finger at the corner||
3321|030|H|of the eye near the nose and apply gentle pressure. This will||
3321|031|H|prevent the medication from draining away from the eye. Try not||
3321|032|H|to blink and do not rub the eye. Do not rinse the dropper.||
3321|033|H|   If you are using other kinds of eye drops, wait at least five||
3321|034|H|minutes before applying the other medications.||
3321|035|H|   Wait several minutes for your vision to clear before driving||
3321|036|H|or operating machinery.||
3321|037|H|   Use this medication regularly to get the most benefit from it.||
3321|038|H|To help you remember, use it at the same times each day. Continue||
3321|039|H|to use this medication for the full time prescribed, even if||
3321|040|H|symptoms disappear after a few days. Stopping the medication too||
3321|041|H|early may result in a return of the infection.||
3321|042|H|   Tell you doctor if your condition does not get better in 7||
3321|043|H|days.||
3321|044|B|||
3321|045|S|SIDE EFFECTS:  Blurred vision, watery eyes, eye||
3321|046|S|pain/dryness/redness/itchiness may occur. If any of these effects||
3321|047|S|last or get worse, tell your doctor.||
3321|048|S|   Remember that this medication has been prescribed because your||
3321|049|S|doctor has judged that the benefit to you is greater than the||
3321|050|S|risk of side effects. Many people using this medication do not||
3321|051|S|have serious side effects.||
3321|052|S|   Use of this medication for prolonged or repeated periods may||
3321|053|S|result in a new fungal eye infection. Do not use it for longer||
3321|054|S|than prescribed. Contact your doctor if you notice new or||
3321|055|S|worsening symptoms.||
3321|056|S|   Tell your doctor right away if you have any serious side||
3321|057|S|effects, including: swelling of the eye.||
3321|058|S|   A very serious allergic reaction to this drug is rare.||
3321|059|S|However, get medical help right away if you notice any symptoms||
3321|060|S|of a serious allergic reaction, including: rash, itching/swelling||
3321|061|S|(especially of the face/tongue/throat), dizziness, trouble||
3321|062|S|breathing.||
3321|063|S|   This is not a complete list of possible side effects. If you||
3321|064|S|notice other effects not listed above, contact your doctor or||
3321|065|S|pharmacist.||
3321|066|S|   In the US -||
3321|067|S|   Call your doctor for medical advice about side effects. You||
3321|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3321|069|S|www.fda.gov/medwatch.||
3321|070|S|   In Canada - Call your doctor for medical advice about side||
3321|071|S|effects. You may report side effects to Health Canada at||
3321|072|S|1-866-234-2345.||
3321|073|B|||
3321|074|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
3321|075|P|pharmacist if you are allergic to it; or to quinolone antibiotics||
3321|076|P|(such as ciprofloxacin); or if you have any other allergies. This||
3321|077|P|product may contain inactive ingredients, which can cause||
3321|078|P|allergic reactions or other problems. Talk to your pharmacist for||
3321|079|P|more details.||
3321|080|P|   Before using this medication, tell your doctor or pharmacist||
3321|081|P|your medical history.||
3321|082|P|   After you apply this drug, your vision may become temporarily||
3321|083|P|blurred or unstable. Do not drive, use machinery, or do anything||
3321|084|P|that needs clear vision until you can do it safely.||
3321|085|P|   During pregnancy, this medication should be used only when||
3321|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
3321|087|P|   It is unknown if this drug passes into breast milk. Consult||
3321|088|P|your doctor before breastfeeding.||
3321|089|B|||
3321|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3321|091|I|medications work or increase your risk for serious side effects.||
3321|092|I|This document does not contain all possible drug interactions.||
3321|093|I|Keep a list of all the products you use (including||
3321|094|I|prescription/nonprescription drugs and herbal products) and share||
3321|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
3321|096|I|the dosage of any medicines without your doctor's approval.||
3321|097|B|||
3321|098|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3321|099|O|has overdosed and has serious symptoms such as passing out or||
3321|100|O|trouble breathing, call 911. Otherwise, call a poison control||
3321|101|O|center right away. US residents can call 1-800-222-1222. Canada||
3321|102|O|residents can call 1-844-764-7669.||
3321|103|B|||
3321|104|N|NOTES:  This medication has been prescribed for your current||
3321|105|N|condition only. Do not use it later for another infection unless||
3321|106|N|your doctor tells you to.||
3321|107|N|   Do not share this medication with others.||
3321|108|B|||
3321|109|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3321|110|D|If it is near the time of the next dose, skip the missed dose.||
3321|111|D|Use your next dose at the regular time. Do not double the dose to||
3321|112|D|catch up.||
3321|113|B|||
3321|114|R|STORAGE:  Store in the refrigerator or at room temperature. Do||
3321|115|R|not freeze. Keep all medications away from children and pets.||
3321|116|R|   Do not flush medications down the toilet or pour them into a||
3321|117|R|drain unless instructed to do so. Properly discard this product||
3321|118|R|when it is expired or no longer needed. Consult your pharmacist||
3321|119|R|or local waste disposal company.||
3321|120|B|||
3321|121|A|Information last revised November 2024.||
3321|122|A|Copyright(c) 2025 First Databank, Inc.||
3321|123|B|||
3324|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3324|002|Z|does NOT have all possible information about this product. This||
3324|003|Z|information does not assure that this product is safe, effective,||
3324|004|Z|or appropriate for you. This information is not individual||
3324|005|Z|medical advice and does not substitute for the advice of your||
3324|006|Z|health care professional. Always ask your health care||
3324|007|Z|professional for complete information about this product and your||
3324|008|Z|specific health needs.||
3324|009|B|||
3324|010|T|CYPROHEPTADINE - ORAL||
3324|011|F|(SYE-proe-HEP-ta-deen)||
3324|012|B|||
3324|013|C|COMMON BRAND NAME(S): Periactin||
3324|014|B|||
3324|015|U|USES:  Cyproheptadine is an antihistamine used to relieve allergy||
3324|016|U|symptoms such as watery eyes, runny nose, itching eyes/nose,||
3324|017|U|sneezing, hives, and itching. It works by blocking a certain||
3324|018|U|natural substance (histamine) that your body makes during an||
3324|019|U|allergic reaction. This medication also blocks another natural||
3324|020|U|substance in your body (serotonin).||
3324|021|U|   This medication should not be used in newborn or premature||
3324|022|U|infants.||
3324|023|B|||
3324|024|H|HOW TO USE:  Take this medication by mouth with or without food||
3324|025|H|as directed by your doctor, usually 2 to 3 times a day. If you||
3324|026|H|are using the liquid form of this medication, carefully measure||
3324|027|H|the dose using a special measuring device/spoon. Do not use a||
3324|028|H|household spoon because you may not get the correct dose.||
3324|029|H|   The dosage is based on your age, medical condition, and||
3324|030|H|response to treatment. Children's dosage may also be based on||
3324|031|H|weight and body size. Do not increase your dose or take this||
3324|032|H|medication more often than directed.||
3324|033|H|   Tell your doctor if your condition does not get better or if||
3324|034|H|it gets worse.||
3324|035|B|||
3324|036|S|SIDE EFFECTS:  Drowsiness, dizziness, blurred vision,||
3324|037|S|constipation, or dry mouth/nose/throat may occur. If any of these||
3324|038|S|effects last or get worse, tell your doctor or pharmacist||
3324|039|S|promptly.||
3324|040|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
3324|041|S|chips, chew (sugarless) gum, drink water, or use a saliva||
3324|042|S|substitute.||
3324|043|S|   Remember that this medication has been prescribed because your||
3324|044|S|doctor has judged that the benefit to you is greater than the||
3324|045|S|risk of side effects. Many people using this medication do not||
3324|046|S|have serious side effects.||
3324|047|S|   Tell your doctor right away if you have any serious side||
3324|048|S|effects, including: mental/mood changes (such as restlessness,||
3324|049|S|confusion, hallucinations), shaking (tremor), difficulty||
3324|050|S|urinating, fast/irregular heartbeat.||
3324|051|S|   Get medical help right away if you have any very serious side||
3324|052|S|effects, including: seizures.||
3324|053|S|   A very serious allergic reaction to this drug is rare.||
3324|054|S|However, get medical help right away if you notice any symptoms||
3324|055|S|of a serious allergic reaction, including: rash, itching/swelling||
3324|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3324|057|S|breathing.||
3324|058|S|   This is not a complete list of possible side effects. If you||
3324|059|S|notice other effects not listed above, contact your doctor or||
3324|060|S|pharmacist.||
3324|061|S|   In the US -||
3324|062|S|   Call your doctor for medical advice about side effects. You||
3324|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3324|064|S|www.fda.gov/medwatch.||
3324|065|S|   In Canada - Call your doctor for medical advice about side||
3324|066|S|effects. You may report side effects to Health Canada at||
3324|067|S|1-866-234-2345.||
3324|068|B|||
3324|069|P|PRECAUTIONS:  Before taking cyproheptadine, tell your doctor or||
3324|070|P|pharmacist if you are allergic to it; or if you have any other||
3324|071|P|allergies. This product may contain inactive ingredients, which||
3324|072|P|can cause allergic reactions or other problems. Talk to your||
3324|073|P|pharmacist for more details.||
3324|074|P|   Before using this medication, tell your doctor or pharmacist||
3324|075|P|your medical history, especially of: breathing problems (such as||
3324|076|P|asthma, emphysema), high pressure in the eye (glaucoma), heart||
3324|077|P|disease, high blood pressure, kidney disease, seizures,||
3324|078|P|stomach/intestine problems (such as ulcers, blockage), overactive||
3324|079|P|thyroid (hyperthyroidism), difficulty urinating (for example, due||
3324|080|P|to enlarged prostate).||
3324|081|P|   This drug may make you dizzy or drowsy or blur your vision.||
3324|082|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
3324|083|P|drowsy. Do not drive, use machinery, or do anything that needs||
3324|084|P|alertness or clear vision until you can do it safely. Avoid||
3324|085|P|alcoholic beverages. Talk to your doctor if you are using||
3324|086|P|marijuana (cannabis).||
3324|087|P|   Before having surgery, tell your doctor or dentist about all||
3324|088|P|the products you use (including prescription drugs,||
3324|089|P|nonprescription drugs, and herbal products).||
3324|090|P|   Liquid products may contain alcohol and/or sugar. Caution is||
3324|091|P|advised if you have diabetes, liver disease, or any other||
3324|092|P|condition that requires you to limit/avoid these substances in||
3324|093|P|your diet. Ask your doctor or pharmacist about using this product||
3324|094|P|safely.||
3324|095|P|   Children may be more sensitive to the side effects of this||
3324|096|P|drug. This drug can often cause excitement in young children||
3324|097|P|instead of drowsiness.||
3324|098|P|   Older adults may be more sensitive to the side effects of this||
3324|099|P|drug, especially drowsiness, dizziness, constipation, confusion,||
3324|100|P|or trouble urinating. Drowsiness, dizziness, and confusion can||
3324|101|P|increase the risk of falling.||
3324|102|P|   During pregnancy, this medication should be used only when||
3324|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
3324|104|P|   It is unknown if this medication passes into breast milk.||
3324|105|P|Consult your doctor before breastfeeding.||
3324|106|B|||
3324|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3324|108|I|medications work or increase your risk for serious side effects.||
3324|109|I|This document does not contain all possible drug interactions.||
3324|110|I|Keep a list of all the products you use (including||
3324|111|I|prescription/nonprescription drugs and herbal products) and share||
3324|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
3324|113|I|the dosage of any medicines without your doctor's approval.||
3324|114|I|   Tell your doctor or pharmacist if you are taking other||
3324|115|I|products that cause drowsiness such as opioid pain or cough||
3324|116|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
3324|117|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
3324|118|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
3324|119|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
3324|120|I|diphenhydramine).||
3324|121|I|   Check the labels on all your medicines (such as allergy or||
3324|122|I|cough-and-cold products) because they may contain ingredients||
3324|123|I|that cause drowsiness. Ask your pharmacist about using those||
3324|124|I|products safely.||
3324|125|I|   Do not use with any other antihistamines applied to the skin||
3324|126|I|(such as diphenhydramine cream, ointment, spray) because||
3324|127|I|increased side effects may occur.||
3324|128|I|   This medication may interfere with certain lab tests (such as||
3324|129|I|allergy skin testing, metyrapone test), possibly causing false||
3324|130|I|test results. Make sure lab personnel and all your doctors know||
3324|131|I|you use this drug.||
3324|132|B|||
3324|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3324|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3324|135|O|poison control center right away. US residents can call||
3324|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3324|137|O|Symptoms of overdose may include: severe drowsiness, seizures,||
3324|138|O|widened pupils. In children, mental/mood changes (such as||
3324|139|O|restlessness, irritability, hallucinations) may occur before||
3324|140|O|drowsiness.||
3324|141|B|||
3324|142|N|NOTES:  Do not share this medication with others.||
3324|143|B|||
3324|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3324|145|D|remember. If it is near the time of the next dose, skip the||
3324|146|D|missed dose. Take your next dose at the regular time. Do not||
3324|147|D|double the dose to catch up.||
3324|148|B|||
3324|149|R|STORAGE:  Store at room temperature away from light and moisture.||
3324|150|R|Do not freeze the liquid form of this medication. Do not store in||
3324|151|R|the bathroom. Keep all medications away from children and pets.||
3324|152|R|   Do not flush medications down the toilet or pour them into a||
3324|153|R|drain unless instructed to do so. Properly discard this product||
3324|154|R|when it is expired or no longer needed. Consult your pharmacist||
3324|155|R|or local waste disposal company.||
3324|156|B|||
3324|157|A|Information last revised October 2024.||
3324|158|A|Copyright(c) 2025 First Databank, Inc.||
3324|159|B|||
3326|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3326|002|Z|does NOT have all possible information about this product. This||
3326|003|Z|information does not assure that this product is safe, effective,||
3326|004|Z|or appropriate for you. This information is not individual||
3326|005|Z|medical advice and does not substitute for the advice of your||
3326|006|Z|health care professional. Always ask your health care||
3326|007|Z|professional for complete information about this product and your||
3326|008|Z|specific health needs.||
3326|009|B|||
3326|010|T|FLUCONAZOLE 150 MG - ORAL||
3326|011|F|(floo-KON-a-zole)||
3326|012|B|||
3326|013|C|COMMON BRAND NAME(S): Diflucan||
3326|014|B|||
3326|015|U|USES:  Fluconazole is used to treat vaginal yeast infections. It||
3326|016|U|works by stopping the growth of common types of vaginal yeast||
3326|017|U|(fungus). This medication belongs to a class of drugs called||
3326|018|U|azole antifungals.||
3326|019|B|||
3326|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3326|021|H|from your pharmacist before you start taking fluconazole and each||
3326|022|H|time you get a refill. If you have any questions, ask your doctor||
3326|023|H|or pharmacist.||
3326|024|H|   Take this medication by mouth with or without food as directed||
3326|025|H|by your doctor, usually as a single dose at any time of the day.||
3326|026|H|   In Canada, some brands of this medication are available||
3326|027|H|without a prescription. Before taking over-the-counter||
3326|028|H|fluconazole, read the product instructions and talk to your||
3326|029|H|doctor if this is your first vaginal yeast infection, if this is||
3326|030|H|your second infection within 2 months, or if you are considering||
3326|031|H|treatment for a girl under 12 years old.||
3326|032|H|   The effect of this medication continues for several days. Tell||
3326|033|H|your doctor if your condition does not get better after a few||
3326|034|H|days or if it gets worse. If you think you may have a serious||
3326|035|H|medical problem, get medical help right away.||
3326|036|B|||
3326|037|S|SIDE EFFECTS:  Nausea, diarrhea, stomach pain, headache, or||
3326|038|S|dizziness may occur. If any of these effects last or get worse,||
3326|039|S|tell your doctor or pharmacist promptly.||
3326|040|S|   If your doctor has directed you to use this product, remember||
3326|041|S|that your doctor has judged that the benefit to you is greater||
3326|042|S|than the risk of side effects. Many people using this product do||
3326|043|S|not have serious side effects.||
3326|044|S|   Get medical help right away if you have any very serious side||
3326|045|S|effects, including: fast/irregular heartbeat, severe dizziness,||
3326|046|S|fainting.||
3326|047|S|   This drug may rarely cause serious liver disease. Get medical||
3326|048|S|help right away if you develop any signs of liver disease,||
3326|049|S|including: nausea/vomiting that doesn't stop, severe||
3326|050|S|stomach/abdominal pain, yellowing eyes/skin, dark urine, unusual||
3326|051|S|tiredness.||
3326|052|S|   A very serious allergic reaction to this drug is rare.||
3326|053|S|However, get medical help right away if you notice any symptoms||
3326|054|S|of a serious allergic reaction, including: fever, swollen lymph||
3326|055|S|nodes, rash, itching/swelling (especially of the||
3326|056|S|face/tongue/throat), severe dizziness, trouble breathing.||
3326|057|S|   This is not a complete list of possible side effects. If you||
3326|058|S|notice other effects not listed above, contact your doctor or||
3326|059|S|pharmacist.||
3326|060|S|   In the US -||
3326|061|S|   Call your doctor for medical advice about side effects. You||
3326|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3326|063|S|www.fda.gov/medwatch.||
3326|064|S|   In Canada - Call your doctor for medical advice about side||
3326|065|S|effects. You may report side effects to Health Canada at||
3326|066|S|1-866-234-2345.||
3326|067|B|||
3326|068|P|PRECAUTIONS:  Before taking fluconazole, tell your doctor or||
3326|069|P|pharmacist if you are allergic to it; or to other azole||
3326|070|P|antifungal drugs (such as ketoconazole, itraconazole); or if you||
3326|071|P|have any other allergies. This product may contain inactive||
3326|072|P|ingredients, which can cause allergic reactions or other||
3326|073|P|problems. Talk to your pharmacist for more details.||
3326|074|P|   Before using this medication, tell your doctor or pharmacist||
3326|075|P|your medical history, especially of: liver disease, kidney||
3326|076|P|disease.||
3326|077|P|   Fluconazole may cause a condition that affects the heart||
3326|078|P|rhythm (QT prolongation). QT prolongation can rarely cause||
3326|079|P|serious (rarely fatal) fast/irregular heartbeat and other||
3326|080|P|symptoms (such as severe dizziness, fainting) that need medical||
3326|081|P|attention right away.||
3326|082|P|   The risk of QT prolongation may be increased if you have||
3326|083|P|certain medical conditions or are taking other drugs that may||
3326|084|P|cause QT prolongation. Before using fluconazole, tell your doctor||
3326|085|P|or pharmacist of all the drugs you take and if you have any of||
3326|086|P|the following conditions: certain heart problems (heart failure,||
3326|087|P|slow heartbeat, QT prolongation in the EKG), family history of||
3326|088|P|certain heart problems (QT prolongation in the EKG, sudden||
3326|089|P|cardiac death).||
3326|090|P|   Low levels of potassium or magnesium in the blood may also||
3326|091|P|increase your risk of QT prolongation. This risk may increase if||
3326|092|P|you use certain drugs (such as diuretics/"water pills") or if you||
3326|093|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3326|094|P|Talk to your doctor about using fluconazole safely.||
3326|095|P|   Although uncommon, this drug may make you dizzy. Alcohol or||
3326|096|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
3326|097|P|machinery, or do anything that needs alertness until you can do||
3326|098|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
3326|099|P|are using marijuana (cannabis).||
3326|100|P|   Before having surgery, tell your doctor or dentist about all||
3326|101|P|the products you use (including prescription drugs,||
3326|102|P|nonprescription drugs, and herbal products).||
3326|103|P|   Older adults may be more sensitive to the side effects of this||
3326|104|P|drug, especially QT prolongation (see above).||
3326|105|P|   During pregnancy, this medication should be used only when||
3326|106|P|clearly needed. It may harm an unborn baby if taken during the||
3326|107|P|first 3 months of pregnancy. Discuss the risks and benefits with||
3326|108|P|your doctor, and ask if you should use a medication applied in or||
3326|109|P|around the vagina instead.||
3326|110|P|   Fluconazole passes into breast milk but is unlikely to harm a||
3326|111|P|nursing infant. Consult your doctor before breastfeeding.||
3326|112|B|||
3326|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3326|114|I|medications work or increase your risk for serious side effects.||
3326|115|I|This document does not contain all possible drug interactions.||
3326|116|I|Keep a list of all the products you use (including||
3326|117|I|prescription/nonprescription drugs and herbal products) and share||
3326|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
3326|119|I|the dosage of any medicines without your doctor's approval.||
3326|120|I|   Products that may interact with this drug include:||
3326|121|I|clopidogrel.||
3326|122|I|   Many drugs besides fluconazole may affect the heart rhythm (QT||
3326|123|I|prolongation), including pimozide, quinidine, macrolide||
3326|124|I|antibiotics (such as erythromycin), among others.||
3326|125|I|   Fluconazole can slow down the removal of other medications||
3326|126|I|from your body, which can affect how they work. Examples of||
3326|127|I|affected drugs include abrocitinib, deuruxolitinib, domperidone,||
3326|128|I|flibanserin, lemborexant, lomitapide, macitentan, mavacamten,||
3326|129|I|nirogacestat, rilzabrutinib, taletrectinib, among others.||
3326|130|B|||
3326|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3326|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3326|133|O|poison control center right away. US residents can call||
3326|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3326|135|O|Symptoms of overdose may include: hallucinations, mental/mood||
3326|136|O|changes.||
3326|137|B|||
3326|138|N|NOTES:  Not applicable.||
3326|139|B|||
3326|140|D|MISSED DOSE:  Not applicable.||
3326|141|B|||
3326|142|R|STORAGE:  Store at room temperature away from light and moisture.||
3326|143|R|Do not store in the bathroom. Keep all medications away from||
3326|144|R|children and pets.||
3326|145|R|   Do not flush medications down the toilet or pour them into a||
3326|146|R|drain unless instructed to do so. Properly discard this product||
3326|147|R|when it is expired or no longer needed. Consult your pharmacist||
3326|148|R|or local waste disposal company.||
3326|149|B|||
3326|150|A|Information last revised September 2025.||
3326|151|A|Copyright(c) 2025 First Databank, Inc.||
3326|152|B|||
3330|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3330|002|Z|does NOT have all possible information about this product. This||
3330|003|Z|information does not assure that this product is safe, effective,||
3330|004|Z|or appropriate for you. This information is not individual||
3330|005|Z|medical advice and does not substitute for the advice of your||
3330|006|Z|health care professional. Always ask your health care||
3330|007|Z|professional for complete information about this product and your||
3330|008|Z|specific health needs.||
3330|009|B|||
3330|010|T|EMTRICITABINE - ORAL||
3330|011|F|(em-tri-SITE-ah-bean)||
3330|012|B|||
3330|013|C|COMMON BRAND NAME(S): Emtriva||
3330|014|B|||
3330|015|W|WARNING:  This medication is not approved for the treatment of||
3330|016|W|hepatitis B virus infection. If you have hepatitis B infection in||
3330|017|W|addition to HIV, your hepatitis symptoms may get worse or become||
3330|018|W|very serious if you stop taking emtricitabine. Talk with your||
3330|019|W|doctor before stopping this medication. Your doctor will perform||
3330|020|W|liver function tests for several months after you stop||
3330|021|W|emtricitabine. Tell your doctor right away if you develop||
3330|022|W|symptoms of worsening liver problems.||
3330|023|B|||
3330|024|U|USES:  Emtricitabine is used with other HIV medications to help||
3330|025|U|control HIV infection. It helps to decrease the amount of HIV in||
3330|026|U|your body so your immune system can work better. This lowers your||
3330|027|U|chance of getting HIV complications (such as new infections,||
3330|028|U|cancer) and improves your quality of life. Emtricitabine belongs||
3330|029|U|to a class of drugs known as nucleoside reverse transcriptase||
3330|030|U|inhibitors-NRTI.||
3330|031|U|   Emtricitabine is not a cure for HIV infection. To decrease||
3330|032|U|your risk of spreading HIV disease to others, continue to take||
3330|033|U|all HIV medications exactly as prescribed by your doctor. Use an||
3330|034|U|effective barrier method (latex or polyurethane condoms/dental||
3330|035|U|dams) during sexual activity as directed by your doctor. Do not||
3330|036|U|share personal items (such as needles/syringes, toothbrushes, and||
3330|037|U|razors) that may have contacted blood or other body fluids.||
3330|038|U|Consult your doctor or pharmacist for more details.||
3330|039|B|||
3330|040|V|OTHER USES:  This section contains uses of this drug that are not||
3330|041|V|listed in the approved professional labeling for the drug but||
3330|042|V|that may be prescribed by your health care professional. Use this||
3330|043|V|drug for a condition that is listed in this section only if it||
3330|044|V|has been so prescribed by your health care professional.||
3330|045|V|   This product may also be used to lessen the risk of HIV||
3330|046|V|infection after contact with the virus (for example, due to a||
3330|047|V|needle stick). Ask your doctor for more details.||
3330|048|B|||
3330|049|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3330|050|H|from your pharmacist before you start taking emtricitabine and||
3330|051|H|each time you get a refill. If you have any questions, ask your||
3330|052|H|doctor or pharmacist.||
3330|053|H|   Take this medication by mouth with or without food as directed||
3330|054|H|by your doctor, usually once daily. If you are using the liquid||
3330|055|H|form of this medication, carefully measure the dose using a||
3330|056|H|special measuring device/spoon. Do not use a household spoon||
3330|057|H|because you may not get the correct dose.||
3330|058|H|   The dosage is based on your medical condition, dosage form||
3330|059|H|(capsule or liquid), and response to treatment. Children's dosage||
3330|060|H|may also be based on weight. Do not switch between the capsule||
3330|061|H|and liquid forms.||
3330|062|H|   For the best effect, take this medication at evenly spaced||
3330|063|H|times. To help you remember, take this medication at the same||
3330|064|H|time every day.||
3330|065|H|   It is very important to keep taking this medication (and other||
3330|066|H|HIV medications) exactly as prescribed by your doctor. Do not||
3330|067|H|skip any doses. Refill your medication before you run out.||
3330|068|H|   Do not take more or less of this drug than prescribed or stop||
3330|069|H|taking it (or other HIV medicines) even for a short time unless||
3330|070|H|directed to do so by your doctor. Skipping or changing your dose||
3330|071|H|without approval from your doctor may cause the amount of virus||
3330|072|H|to increase, make the infection more difficult to treat||
3330|073|H|(resistant), or worsen side effects.||
3330|074|B|||
3330|075|S|SIDE EFFECTS:  Headache, diarrhea, trouble sleeping, or darkening||
3330|076|S|skin color on palms of hands and soles of feet may occur. If any||
3330|077|S|of these effects last or get worse, tell your doctor or||
3330|078|S|pharmacist promptly.||
3330|079|S|   Remember that this medication has been prescribed because your||
3330|080|S|doctor has judged that the benefit to you is greater than the||
3330|081|S|risk of side effects. Many people using this medication do not||
3330|082|S|have serious side effects.||
3330|083|S|   As your immune system gets stronger, it can begin to fight off||
3330|084|S|infections you already had, possibly causing disease symptoms to||
3330|085|S|come back. You could also have symptoms if your immune system||
3330|086|S|becomes overactive. This reaction may happen at any time (soon||
3330|087|S|after starting HIV treatment or many months later). Tell your||
3330|088|S|doctor right away if you have any serious symptoms, including:||
3330|089|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
3330|090|S|that doesn't go away, headaches that are severe or don't go away,||
3330|091|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
3330|092|S|changes, signs of infection (such as sore throat that doesn't go||
3330|093|S|away, fever, chills, swollen lymph nodes, non-healing skin||
3330|094|S|sores), signs of an overactive thyroid (such as irritability,||
3330|095|S|nervousness, heat intolerance, fast/pounding/irregular||
3330|096|S|heartbeat).||
3330|097|S|   Tell your doctor right away if you have any serious side||
3330|098|S|effects, including: mental/mood changes (such as depression).||
3330|099|S|   Rarely, this medication can cause severe (sometimes fatal)||
3330|100|S|liver and blood problems (lactic acidosis). Tell your doctor||
3330|101|S|right away if you develop symptoms of liver problems (such as||
3330|102|S|nausea/vomiting that doesn't stop, loss of appetite,||
3330|103|S|stomach/abdominal pain, yellowing eyes/skin, dark urine) or||
3330|104|S|lactic acidosis (such as deep/rapid breathing, drowsiness,||
3330|105|S|nausea/vomiting, unusual weakness).||
3330|106|S|   A very serious allergic reaction to this drug is rare.||
3330|107|S|However, get medical help right away if you notice any symptoms||
3330|108|S|of a serious allergic reaction, including: rash, itching/swelling||
3330|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3330|110|S|breathing.||
3330|111|S|   This is not a complete list of possible side effects. If you||
3330|112|S|notice other effects not listed above, contact your doctor or||
3330|113|S|pharmacist.||
3330|114|S|   In the US -||
3330|115|S|   Call your doctor for medical advice about side effects. You||
3330|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3330|117|S|www.fda.gov/medwatch.||
3330|118|S|   In Canada - Call your doctor for medical advice about side||
3330|119|S|effects. You may report side effects to Health Canada at||
3330|120|S|1-866-234-2345.||
3330|121|B|||
3330|122|P|PRECAUTIONS:  Before taking emtricitabine, tell your doctor or||
3330|123|P|pharmacist if you are allergic to it; or if you have any other||
3330|124|P|allergies. This product may contain inactive ingredients, which||
3330|125|P|can cause allergic reactions or other problems. Talk to your||
3330|126|P|pharmacist for more details.||
3330|127|P|   Before using this medication, tell your doctor or pharmacist||
3330|128|P|your medical history, especially of: kidney problems, liver||
3330|129|P|problems (such as hepatitis, cirrhosis), alcohol use.||
3330|130|P|   Before having surgery, tell your doctors or dentist about all||
3330|131|P|the products you use (including prescription drugs,||
3330|132|P|nonprescription drugs, and herbal products).||
3330|133|P|   Older adults may be more sensitive to the side effects of this||
3330|134|P|drug.||
3330|135|P|   Tell your doctor if you are pregnant before using this||
3330|136|P|medication. Treatment can lower the risk of passing HIV infection||
3330|137|P|to your baby. Discuss the risks and benefits with your doctor.||
3330|138|P|   This medication passes into breast milk, but is unlikely to||
3330|139|P|harm a nursing infant. Because breast milk may transmit HIV,||
3330|140|P|consult your doctor before breastfeeding.||
3330|141|B|||
3330|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3330|143|I|medications work or increase your risk for serious side effects.||
3330|144|I|This document does not contain all possible drug interactions.||
3330|145|I|Keep a list of all the products you use (including||
3330|146|I|prescription/nonprescription drugs and herbal products) and share||
3330|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
3330|148|I|the dosage of any medicines without your doctor's approval.||
3330|149|I|   A product that may interact with this drug is: orlistat.||
3330|150|I|   Lamivudine is similar to emtricitabine and should not be taken||
3330|151|I|with this medication. Check the labels on all your HIV medicines||
3330|152|I|because they may contain the same ingredients as found in this||
3330|153|I|product. Do not take other products that contain emtricitabine.||
3330|154|B|||
3330|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3330|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3330|157|O|poison control center right away. US residents can call||
3330|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3330|159|B|||
3330|160|N|NOTES:  Do not share this medication with others.||
3330|161|N|   Lab and/or medical tests (such as liver tests, viral load,||
3330|162|N|T-cell counts, test for hepatitis B virus) should be done before||
3330|163|N|you start taking this medication and while you are taking it.||
3330|164|N|Keep all medical and lab appointments.||
3330|165|B|||
3330|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3330|167|D|remember. If it is near the time of the next dose, skip the||
3330|168|D|missed dose. Take your next dose at the regular time. Do not||
3330|169|D|double the dose to catch up.||
3330|170|B|||
3330|171|R|STORAGE:  Keep this medication in the original container. Store||
3330|172|R|the capsules at room temperature away from light and moisture. Do||
3330|173|R|not store in the bathroom. Store the oral solution in the||
3330|174|R|refrigerator. Do not freeze. This solution may also be stored at||
3330|175|R|room temperature if needed. If the solution is stored at room||
3330|176|R|temperature, discard after 3 months. Keep all medications away||
3330|177|R|from children and pets.||
3330|178|R|   Do not flush medications down the toilet or pour them into a||
3330|179|R|drain unless instructed to do so. Properly discard this product||
3330|180|R|when it is expired or no longer needed. Consult your pharmacist||
3330|181|R|or local waste disposal company.||
3330|182|B|||
3330|183|A|Information last revised April 2025.||
3330|184|A|Copyright(c) 2025 First Databank, Inc.||
3330|185|B|||
3333|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3333|002|Z|does NOT have all possible information about this product. This||
3333|003|Z|information does not assure that this product is safe, effective,||
3333|004|Z|or appropriate for you. This information is not individual||
3333|005|Z|medical advice and does not substitute for the advice of your||
3333|006|Z|health care professional. Always ask your health care||
3333|007|Z|professional for complete information about this product and your||
3333|008|Z|specific health needs.||
3333|009|B|||
3333|010|T|BETAMETHASONE/CALCIPOTRIENE (CALCIPOTRIOL) - TOPICAL||
3333|011|F|(BAY-ta-METH-a-sone/KAL-si-poe-TRYE-een/KAL-si-poe-TRYE-ol)||
3333|012|B|||
3333|013|C|COMMON BRAND NAME(S): Enstilar, Taclonex||
3333|014|B|||
3333|015|U|USES:  This medication is used to treat psoriasis. It helps to||
3333|016|U|reduce the redness, thickening, and scaling of the skin that||
3333|017|U|occurs with this condition. Healthy skin lowers your risk for||
3333|018|U|infection and protects you against the environment. This product||
3333|019|U|contains 2 drugs. Betamethasone is a very strong corticosteroid||
3333|020|U|drug that works by decreasing swelling, redness, and itching.||
3333|021|U|Calcipotriene is a form of vitamin D. It is also known as||
3333|022|U|calcipotriol in other countries. It works by slowing down the||
3333|023|U|growth of skin cells so that they don't build up into thickened,||
3333|024|U|scaly skin patches.||
3333|025|U|   This product should not be used if you have certain types of||
3333|026|U|psoriasis (skin patches with pus-filled blisters, psoriasis over||
3333|027|U|most of your body with intense redness/shedding/oozing). Consult||
3333|028|U|your doctor for more information.||
3333|029|B|||
3333|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3333|031|H|from your pharmacist before you start using this product and each||
3333|032|H|time you get a refill. If you have any questions, ask your doctor||
3333|033|H|or pharmacist.||
3333|034|H|   This medication is for use on the skin only. Apply a thin||
3333|035|H|layer to the affected area(s) as directed by your doctor, usually||
3333|036|H|once daily. Rub it in gently and completely. Wash your hands||
3333|037|H|after using, unless you are using this medication to treat the||
3333|038|H|hands. Avoid getting any medication in the eyes or mouth. If this||
3333|039|H|occurs, rinse right away with water. Do not apply this product to||
3333|040|H|the face, underarms, or groin area. Do not use this medication||
3333|041|H|for more than 4 weeks if you are using the ointment or foam (or 8||
3333|042|H|weeks if you are using the cream) unless directed by your doctor.||
3333|043|H|   If you are using the ointment, because of the increased risk||
3333|044|H|of side effects, adults should not use more than 100 grams of the||
3333|045|H|ointment per week unless directed and closely monitored by the||
3333|046|H|doctor. Also, children and teenagers should not use more than 60||
3333|047|H|grams of the ointment per week.||
3333|048|H|   If you are using the foam, shake the can before using. Do not||
3333|049|H|use more than 60 grams of the foam every 4 days. The foam is||
3333|050|H|flammable until dry. Avoid smoking or being near open flames||
3333|051|H|while using the foam and until the medication has dried.||
3333|052|H|   If you are using the cream, do not use more than 100 grams of||
3333|053|H|the cream per week.||
3333|054|H|   Do not bandage, wrap, or cover the treated area unless your||
3333|055|H|doctor instructs you to do so. Do not apply this medication to||
3333|056|H|large areas of damaged skin or use it in skin folds. Do not apply||
3333|057|H|more of this medication than prescribed or use it more often or||
3333|058|H|for longer than directed. Doing so may increase the amount of||
3333|059|H|medication that is absorbed into your bloodstream, an effect that||
3333|060|H|may increase your risk of side effects.||
3333|061|H|   Tell your doctor if your condition does not get better or if||
3333|062|H|it gets worse. It may take a week to see any improvement and||
3333|063|H|several weeks to see the full benefit of this medication.||
3333|064|B|||
3333|065|S|SIDE EFFECTS:  Itching, burning, redness, or irritation of the||
3333|066|S|skin may occur. If any of these effects last or get worse, tell||
3333|067|S|your doctor or pharmacist promptly.||
3333|068|S|   Remember that this medication has been prescribed because your||
3333|069|S|doctor has judged that the benefit to you is greater than the||
3333|070|S|risk of side effects. Many people using this medication do not||
3333|071|S|have serious side effects.||
3333|072|S|   Tell your doctor right away if you have any serious side||
3333|073|S|effects, including: skin thinning/discoloration/"stretch marks",||
3333|074|S|small red bumps on the skin (folliculitis), worsening of||
3333|075|S|psoriasis.||
3333|076|S|   This product may rarely cause an increase in the level of||
3333|077|S|calcium in your blood. Tell your doctor right away if you notice||
3333|078|S|any of the following unlikely but serious side effects:||
3333|079|S|mental/mood changes, unexplained constipation.||
3333|080|S|   Rarely, it is possible this medication will be absorbed from||
3333|081|S|the skin into the bloodstream. This can lead to side effects of||
3333|082|S|too much corticosteroid. These side effects are more likely in||
3333|083|S|children, and in people who use this medication for a long time||
3333|084|S|or over large areas of the skin. Tell your doctor right away if||
3333|085|S|any of the following side effects occur: unusual/extreme||
3333|086|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
3333|087|S|thirst/urination, vision problems.||
3333|088|S|   A very serious allergic reaction to this drug is rare.||
3333|089|S|However, get medical help right away if you notice any symptoms||
3333|090|S|of a serious allergic reaction, including: rash, itching/swelling||
3333|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3333|092|S|breathing.||
3333|093|S|   This is not a complete list of possible side effects. If you||
3333|094|S|notice other effects not listed above, contact your doctor or||
3333|095|S|pharmacist.||
3333|096|S|   In the US -||
3333|097|S|   Call your doctor for medical advice about side effects. You||
3333|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3333|099|S|www.fda.gov/medwatch.||
3333|100|S|   In Canada - Call your doctor for medical advice about side||
3333|101|S|effects. You may report side effects to Health Canada at||
3333|102|S|1-866-234-2345.||
3333|103|B|||
3333|104|P|PRECAUTIONS:  Before using this product, tell your doctor or||
3333|105|P|pharmacist if you are allergic to betamethasone or calcipotriene;||
3333|106|P|or if you have any other allergies. This product may contain||
3333|107|P|inactive ingredients, which can cause allergic reactions or other||
3333|108|P|problems. Talk to your pharmacist for more details.||
3333|109|P|   Before using this medication, tell your doctor or pharmacist||
3333|110|P|your medical history, especially of: a certain mineral imbalance||
3333|111|P|(high calcium blood level), thin skin in the areas to be treated.||
3333|112|P|   If you have a skin infection or a skin reaction other than||
3333|113|P|psoriasis (such as bacterial skin infection, chickenpox, herpes||
3333|114|P|simplex), it should be treated before you start this medication.||
3333|115|P|Betamethasone and other corticosteroid drugs can slow down your||
3333|116|P|body's response to antibiotic drugs and make it more difficult to||
3333|117|P|clear an infection.||
3333|118|P|   This medication may make you more sensitive to the sun. Limit||
3333|119|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
3333|120|P|sunscreen and wear protective clothing when outdoors. Tell your||
3333|121|P|doctor right away if you get sunburned or have skin||
3333|122|P|blisters/redness. Your doctor may direct you to limit or avoid||
3333|123|P|phototherapy while you use this product. Ask your doctor for||
3333|124|P|details.||
3333|125|P|   Rarely, using corticosteroid medications for a long time or||
3333|126|P|over large areas of skin can make it more difficult for your body||
3333|127|P|to respond to physical stress. Before having surgery or emergency||
3333|128|P|treatment, or if you get a serious illness/injury, tell your||
3333|129|P|doctor or dentist that you are using this medication or have used||
3333|130|P|this medication within the past few months.||
3333|131|P|   Though it is unlikely, this medication may temporarily slow||
3333|132|P|down a child's growth if used for a long time. See the doctor||
3333|133|P|regularly so your child's height can be checked.||
3333|134|P|   During pregnancy, this medication should be used only when||
3333|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
3333|136|P|   It is unknown if this drug passes into breast milk. Consult||
3333|137|P|your doctor before breastfeeding.||
3333|138|B|||
3333|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3333|140|I|medications work or increase your risk for serious side effects.||
3333|141|I|This document does not contain all possible drug interactions.||
3333|142|I|Keep a list of all the products you use (including||
3333|143|I|prescription/nonprescription drugs and herbal products) and share||
3333|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
3333|145|I|the dosage of any medicines without your doctor's approval.||
3333|146|B|||
3333|147|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
3333|148|O|has overdosed and has serious symptoms such as passing out or||
3333|149|O|trouble breathing, call 911. Otherwise, call a poison control||
3333|150|O|center right away. US residents can call 1-800-222-1222. Canada||
3333|151|O|residents can call 1-844-764-7669.||
3333|152|B|||
3333|153|N|NOTES:  Do not share this medication with others.||
3333|154|N|   Lab and/or medical tests (such as adrenal gland function) may||
3333|155|N|be done while you are using this medication, especially if you||
3333|156|N|use it for an extended period of time or apply it over large||
3333|157|N|areas of the body. Consult your doctor for more details.||
3333|158|N|   Try to identify and reduce the triggers that may worsen your||
3333|159|N|psoriasis (such as stress, skin injury). Discuss with your doctor||
3333|160|N|additional ways to control symptoms, such as using a moisturizer||
3333|161|N|to treat dry, itching skin.||
3333|162|B|||
3333|163|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3333|164|D|If it is near the time of the next dose, skip the missed dose.||
3333|165|D|Use your next dose at the regular time. Do not double the dose to||
3333|166|D|catch up.||
3333|167|B|||
3333|168|R|STORAGE:  Different brands of this medication have different||
3333|169|R|storage needs. Check the product package for instructions on how||
3333|170|R|to store your brand, or ask your pharmacist. Also, check the||
3333|171|R|product instructions about how long you may store the product||
3333|172|R|once it has been opened. The foam product is flammable. Keep it||
3333|173|R|away from heat and open flame. Do not puncture the foam can. Keep||
3333|174|R|all medications away from children and pets.||
3333|175|R|   Do not flush medications down the toilet or pour them into a||
3333|176|R|drain unless instructed to do so. Properly discard this product||
3333|177|R|when it is expired or no longer needed. Consult your pharmacist||
3333|178|R|or local waste disposal company.||
3333|179|B|||
3333|180|A|Information last revised July 2025.||
3333|181|A|Copyright(c) 2025 First Databank, Inc.||
3333|182|B|||
3341|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3341|002|Z|does NOT have all possible information about this product. This||
3341|003|Z|information does not assure that this product is safe, effective,||
3341|004|Z|or appropriate for you. This information is not individual||
3341|005|Z|medical advice and does not substitute for the advice of your||
3341|006|Z|health care professional. Always ask your health care||
3341|007|Z|professional for complete information about this product and your||
3341|008|Z|specific health needs.||
3341|009|B|||
3341|010|T|OXALIPLATIN - INJECTION||
3341|011|F|(ox-AL-ih-plah-tin)||
3341|012|B|||
3341|013|C|COMMON BRAND NAME(S): Eloxatin||
3341|014|B|||
3341|015|W|WARNING:  Oxaliplatin may rarely cause a severe (possibly fatal)||
3341|016|W|allergic reaction within minutes after a dose. Get medical help||
3341|017|W|right away if you develop any signs of an allergic reaction (such||
3341|018|W|as rash, itching, swelling, trouble breathing, swelling of||
3341|019|W|throat, dizziness).||
3341|020|B|||
3341|021|U|USES:  This medication is used to treat advanced cancer of the||
3341|022|U|colon and rectum. Oxaliplatin is a chemotherapy drug that||
3341|023|U|contains platinum. It is used to slow or stop cancer cell growth.||
3341|024|B|||
3341|025|V|OTHER USES:  This section contains uses of this drug that are not||
3341|026|V|listed in the approved professional labeling for the drug but||
3341|027|V|that may be prescribed by your health care professional. Use this||
3341|028|V|drug for a condition that is listed in this section only if it||
3341|029|V|has been so prescribed by your health care professional.||
3341|030|V|   This drug may also be used for other types of cancer (such as||
3341|031|V|testicular cancer).||
3341|032|B|||
3341|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3341|034|H|from your health care professional before you receive||
3341|035|H|oxaliplatin.||
3341|036|H|   This medication is usually given by infusion into a vein over||
3341|037|H|at least 2 hours by a health care professional. It is usually||
3341|038|H|given every 2 weeks along with other medications (such as||
3341|039|H|5-fluorouracil and leucovorin). The dosage is based on your||
3341|040|H|medical condition, body size, and response to treatment.||
3341|041|B|||
3341|042|S|SIDE EFFECTS:  Diarrhea, changes in taste, mouth sores,||
3341|043|S|nosebleeds, tiredness, headache, dizziness, or trouble sleeping||
3341|044|S|may occur. Nausea and vomiting may be severe in some patients.||
3341|045|S|Your doctor may prescribe medication to prevent or relieve nausea||
3341|046|S|and vomiting. Eating several small meals, not eating before||
3341|047|S|treatment, or limiting activity may help lessen some of these||
3341|048|S|effects. If any of these effects last or get worse, tell your||
3341|049|S|doctor or pharmacist promptly.||
3341|050|S|   Temporary hair loss may rarely occur. Normal hair growth||
3341|051|S|should return after treatment has ended.||
3341|052|S|   Remember that this medication has been prescribed because your||
3341|053|S|doctor has judged that the benefit to you is greater than the||
3341|054|S|risk of side effects. Many people using this medication do not||
3341|055|S|have serious side effects.||
3341|056|S|   Tell your doctor right away if you have any serious side||
3341|057|S|effects, including: pain/redness/swelling at the injection site,||
3341|058|S|easy or unusual bruising/bleeding, mental/mood changes (such as||
3341|059|S|depression), signs of dehydration (such as decreased urination,||
3341|060|S|increased thirst, dry mouth), muscle||
3341|061|S|pain/tenderness/weakness/cramps, signs of kidney problems (such||
3341|062|S|as change in the amount of urine), pain/redness/swelling of the||
3341|063|S|arms/legs, groin/calf pain.||
3341|064|S|   Oxaliplatin can sometimes affect how your nerves work||
3341|065|S|(peripheral neuropathy). Tell your doctor right away if you||
3341|066|S|develop: sensitivity to cold, trouble||
3341|067|S|breathing/swallowing/speaking, jaw tightness, strange feeling in||
3341|068|S|your tongue, eye pain, chest pressure, numbness/tingling/"pins||
3341|069|S|and needles" sensation of the hands/feet/mouth/throat.||
3341|070|S|   You may lessen these types of nerve problems by avoiding cold||
3341|071|S|drinks and ice and by dressing warmly. Tell your doctor right||
3341|072|S|away if your nerve problems begin to interfere with your normal||
3341|073|S|daily activities (such as walking, writing, eating).||
3341|074|S|   Get medical help right away if you have any very serious side||
3341|075|S|effects, including: severe dizziness, fainting, fast/irregular||
3341|076|S|heartbeat, dry cough, shortness of breath, chest pain, black||
3341|077|S|stools, vomit that looks like coffee grounds, vision changes||
3341|078|S|(such as blurred vision, temporary vision loss), seizures, sudden||
3341|079|S|confusion.||
3341|080|S|   This medication can lower your body's ability to fight an||
3341|081|S|infection. Tell your doctor right away if you develop any signs||
3341|082|S|of an infection (such as sore throat that doesn't go away, fever,||
3341|083|S|chills).||
3341|084|S|   A very serious allergic reaction to this drug is rare.||
3341|085|S|However, get medical help right away if you notice any symptoms||
3341|086|S|of a serious allergic reaction, including: rash, itching/swelling||
3341|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3341|088|S|breathing.||
3341|089|S|   This is not a complete list of possible side effects. If you||
3341|090|S|notice other effects not listed above, contact your doctor or||
3341|091|S|pharmacist.||
3341|092|S|   In the US -||
3341|093|S|   Call your doctor for medical advice about side effects. You||
3341|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3341|095|S|www.fda.gov/medwatch.||
3341|096|S|   In Canada - Call your doctor for medical advice about side||
3341|097|S|effects. You may report side effects to Health Canada at||
3341|098|S|1-866-234-2345.||
3341|099|B|||
3341|100|P|PRECAUTIONS:  Before using oxaliplatin, tell your doctor or||
3341|101|P|pharmacist if you are allergic to it; or to other||
3341|102|P|platinum-containing products (such as cisplatin, carboplatin); or||
3341|103|P|if you have any other allergies. This product may contain||
3341|104|P|inactive ingredients, which can cause allergic reactions or other||
3341|105|P|problems. Talk to your pharmacist for more details.||
3341|106|P|   Before using this medication, tell your doctor or pharmacist||
3341|107|P|your medical history, especially of: kidney problems, blood||
3341|108|P|disorders, bone marrow problems, nerve disorders.||
3341|109|P|   Oxaliplatin may cause a condition that affects the heart||
3341|110|P|rhythm (QT prolongation). QT prolongation can rarely cause||
3341|111|P|serious (rarely fatal) fast/irregular heartbeat and other||
3341|112|P|symptoms (such as severe dizziness, fainting) that need medical||
3341|113|P|attention right away.||
3341|114|P|   The risk of QT prolongation may be increased if you have||
3341|115|P|certain medical conditions or are taking other drugs that may||
3341|116|P|cause QT prolongation. Before using oxaliplatin, tell your doctor||
3341|117|P|or pharmacist of all the drugs you take and if you have any of||
3341|118|P|the following conditions: certain heart problems (heart failure,||
3341|119|P|slow heartbeat, QT prolongation in the EKG), family history of||
3341|120|P|certain heart problems (QT prolongation in the EKG, sudden||
3341|121|P|cardiac death).||
3341|122|P|   Low levels of potassium or magnesium in the blood may also||
3341|123|P|increase your risk of QT prolongation. This risk may increase if||
3341|124|P|you use certain drugs (such as diuretics/"water pills") or if you||
3341|125|P|have conditions such as severe sweating, diarrhea, or vomiting.||
3341|126|P|Talk to your doctor about using oxaliplatin safely.||
3341|127|P|   This drug may make you dizzy or cause vision changes. Alcohol||
3341|128|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
3341|129|P|use machinery, or do anything that needs alertness or clear||
3341|130|P|vision until you can do it safely. Limit alcoholic beverages.||
3341|131|P|Talk to your doctor if you are using marijuana (cannabis).||
3341|132|P|   Tell your health care professional that you are using||
3341|133|P|oxaliplatin before having any immunizations/vaccinations. Avoid||
3341|134|P|contact with people who have recently received live vaccines||
3341|135|P|(such as flu vaccine inhaled through the nose).||
3341|136|P|   Before having surgery, tell your doctor or dentist about all||
3341|137|P|the products you use (including prescription drugs,||
3341|138|P|nonprescription drugs, and herbal products).||
3341|139|P|   To lower your risk of getting cut, bruised, or injured, use||
3341|140|P|caution with sharp objects like razors and nail cutters, and||
3341|141|P|avoid activities such as contact sports.||
3341|142|P|   Older adults may be more sensitive to the side effects of this||
3341|143|P|drug, especially diarrhea, dehydration, low white blood cell||
3341|144|P|count, tiredness, fainting, and QT prolongation (see above).||
3341|145|P|   This medication can affect fertility in both males and||
3341|146|P|females. Ask your doctor for more details.||
3341|147|P|   Tell your doctor if you are pregnant or plan to become||
3341|148|P|pregnant. You should not become pregnant while using oxaliplatin.||
3341|149|P|Oxaliplatin may harm an unborn baby. Your doctor should order a||
3341|150|P|pregnancy test before you start this medication. Women using this||
3341|151|P|medication should ask about reliable forms of birth control||
3341|152|P|during treatment and for 9 months after the last dose. Men using||
3341|153|P|this medication should ask about reliable forms of birth control||
3341|154|P|during treatment and for 6 months after the last dose. If you or||
3341|155|P|your partner becomes pregnant, talk to your doctor right away||
3341|156|P|about the risks and benefits of this medication.||
3341|157|P|   It is unknown if oxaliplatin passes into breast milk. Because||
3341|158|P|of the possible risk to the infant, breastfeeding is not||
3341|159|P|recommended while using this medication and for 3 months after||
3341|160|P|the last dose. Consult your doctor before breastfeeding.||
3341|161|B|||
3341|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3341|163|I|medications work or increase your risk for serious side effects.||
3341|164|I|This document does not contain all possible drug interactions.||
3341|165|I|Keep a list of all the products you use (including||
3341|166|I|prescription/nonprescription drugs and herbal products) and share||
3341|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
3341|168|I|the dosage of any medicines without your doctor's approval.||
3341|169|I|   Some products that may interact with this drug include:||
3341|170|I|aminoglycosides (such as gentamicin, amikacin), amphotericin B,||
3341|171|I|nonsteroidal anti-inflammatory drugs (such as ibuprofen),||
3341|172|I|tacrolimus.||
3341|173|B|||
3341|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3341|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3341|176|O|poison control center right away. US residents can call||
3341|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3341|178|O|Symptoms of overdose may include: severe vomiting, chest pain,||
3341|179|O|shortness of breath, wheezing, very slow heartbeat,||
3341|180|O|numbness/tingling of the arms/legs.||
3341|181|B|||
3341|182|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
3341|183|N|liver/kidney function) should be done while you are using this||
3341|184|N|medication. Keep all medical and lab appointments. Consult your||
3341|185|N|doctor for more details.||
3341|186|B|||
3341|187|D|MISSED DOSE:  It is important to get each dose of this medication||
3341|188|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
3341|189|D|right away for a new dosing schedule.||
3341|190|B|||
3341|191|R|STORAGE:  Not applicable. This medication is given in a clinic||
3341|192|R|and will not be stored at home.||
3341|193|B|||
3341|194|M|MEDICAL ALERT:  Your condition can cause complications in a||
3341|195|M|medical emergency. For information about enrolling in MedicAlert,||
3341|196|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
3341|197|B|||
3341|198|A|Information last revised May 2025.||
3341|199|A|Copyright(c) 2025 First Databank, Inc.||
3341|200|B|||
3343|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3343|002|Z|does NOT have all possible information about this product. This||
3343|003|Z|information does not assure that this product is safe, effective,||
3343|004|Z|or appropriate for you. This information is not individual||
3343|005|Z|medical advice and does not substitute for the advice of your||
3343|006|Z|health care professional. Always ask your health care||
3343|007|Z|professional for complete information about this product and your||
3343|008|Z|specific health needs.||
3343|009|B|||
3343|010|T|ZINC SULFATE - ORAL||
3343|011|F|(zink SUL-fate)||
3343|012|B|||
3343|013|C|COMMON BRAND NAME(S): Orazinc, Zincate||
3343|014|B|||
3343|015|U|USES:  This product is a mineral used to treat or prevent low||
3343|016|U|levels of zinc.||
3343|017|B|||
3343|018|H|HOW TO USE:  Take this product by mouth as directed by your||
3343|019|H|doctor or the product package. Take this product 1 hour before or||
3343|020|H|2 hours after meals. It may be taken with food if it upsets your||
3343|021|H|stomach. Avoid milk, bran, grains, or cereals within 2 hours of||
3343|022|H|taking this product.||
3343|023|H|   Use this product regularly in order to get the most benefit||
3343|024|H|from it. To help you remember, use it at the same time(s) each||
3343|025|H|day.||
3343|026|B|||
3343|027|S|SIDE EFFECTS:  Nausea, stomach upset, heartburn may occur. If any||
3343|028|S|of these effects last or get worse, tell your doctor or||
3343|029|S|pharmacist promptly.||
3343|030|S|   If your doctor has directed you to use this product, remember||
3343|031|S|that your doctor has judged that the benefit to you is greater||
3343|032|S|than the risk of side effects. Many people using this product do||
3343|033|S|not have serious side effects.||
3343|034|S|   Tell your doctor right away if you have any serious side||
3343|035|S|effects, including: signs of infection (such as sore throat that||
3343|036|S|doesn't go away, fever, chills), sores in mouth, unusual||
3343|037|S|tiredness, weakness.||
3343|038|S|   A very serious allergic reaction to this product is rare.||
3343|039|S|However, get medical help right away if you notice any symptoms||
3343|040|S|of a serious allergic reaction, including: rash, itching/swelling||
3343|041|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3343|042|S|breathing.||
3343|043|S|   This is not a complete list of possible side effects. If you||
3343|044|S|notice other effects not listed above, contact your doctor or||
3343|045|S|pharmacist.||
3343|046|S|   In the US -||
3343|047|S|   Call your doctor for medical advice about side effects. You||
3343|048|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3343|049|S|www.fda.gov/medwatch.||
3343|050|S|   In Canada - Call your doctor for medical advice about side||
3343|051|S|effects. You may report side effects to Health Canada at||
3343|052|S|1-866-234-2345.||
3343|053|B|||
3343|054|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
3343|055|P|pharmacist if you have any allergies. This product may contain||
3343|056|P|inactive ingredients, which can cause allergic reactions or other||
3343|057|P|problems. Talk to your pharmacist for more details.||
3343|058|P|   Before using this product, tell your doctor or pharmacist your||
3343|059|P|medical history, especially of: low blood levels of copper.||
3343|060|P|   Before having surgery, tell your doctor or dentist about all||
3343|061|P|the products you use (including prescription drugs,||
3343|062|P|nonprescription drugs, and herbal products).||
3343|063|P|   Tell your doctor if you are pregnant before using this||
3343|064|P|product.||
3343|065|P|   This product passes into breast milk. Consult your doctor||
3343|066|P|before breastfeeding.||
3343|067|B|||
3343|068|I|DRUG INTERACTIONS:  Drug interactions may change how your||
3343|069|I|medications work or increase your risk for serious side effects.||
3343|070|I|This document does not contain all possible drug interactions.||
3343|071|I|Keep a list of all the products you use (including||
3343|072|I|prescription/nonprescription drugs and herbal products) and share||
3343|073|I|it with your doctor and pharmacist. Do not start, stop, or change||
3343|074|I|the dosage of any medicines without your doctor's approval.||
3343|075|I|   This product can decrease the absorption of certain drugs,||
3343|076|I|especially if you take them around the same time. These drugs||
3343|077|I|include bisphosphonates (such as alendronate), penicillamine,||
3343|078|I|quinolone antibiotics (such as ciprofloxacin, levofloxacin),||
3343|079|I|tetracycline antibiotics (such as doxycycline, minocycline),||
3343|080|I|thyroid medications (such as levothyroxine), among others. Ask||
3343|081|I|your doctor or pharmacist how long you should wait between doses||
3343|082|I|of this product and your other medications and to find a dosing||
3343|083|I|schedule that works for all your medications.||
3343|084|B|||
3343|085|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3343|086|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3343|087|O|poison control center right away. US residents can call||
3343|088|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3343|089|O|Symptoms of overdose may include severe nausea, vomiting,||
3343|090|O|dizziness, fainting, and shortness of breath.||
3343|091|B|||
3343|092|N|NOTES:  It is important to maintain a well balanced diet while||
3343|093|N|taking this medicine.||
3343|094|N|   Foods containing good sources of zinc include lean red meats,||
3343|095|N|seafood, peas, and beans.||
3343|096|N|   Lab tests (such as zinc and copper levels) should be done||
3343|097|N|while you are taking this product. Keep all medical and lab||
3343|098|N|appointments. Consult your doctor for more details.||
3343|099|B|||
3343|100|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
3343|101|D|If it is near the time of the next dose, skip the missed dose.||
3343|102|D|Use your next dose at the regular time. Do not double the dose to||
3343|103|D|catch up.||
3343|104|B|||
3343|105|R|STORAGE:  Store at room temperature away from light and moisture.||
3343|106|R|Do not store in the bathroom. Keep all medications away from||
3343|107|R|children and pets.||
3343|108|R|   Do not flush medications down the toilet or pour them into a||
3343|109|R|drain unless instructed to do so. Properly discard this product||
3343|110|R|when it is expired or no longer needed. Consult your pharmacist||
3343|111|R|or local waste disposal company.||
3343|112|B|||
3343|113|A|Information last revised October 2025.||
3343|114|A|Copyright(c) 2025 First Databank, Inc.||
3343|115|B|||
3352|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3352|002|Z|does NOT have all possible information about this product. This||
3352|003|Z|information does not assure that this product is safe, effective,||
3352|004|Z|or appropriate for you. This information is not individual||
3352|005|Z|medical advice and does not substitute for the advice of your||
3352|006|Z|health care professional. Always ask your health care||
3352|007|Z|professional for complete information about this product and your||
3352|008|Z|specific health needs.||
3352|009|B|||
3352|010|T|CODEINE EXTENDED-RELEASE - ORAL||
3352|011|F|(KOE-deen)||
3352|012|B|||
3352|013|W|WARNING:  Codeine has a risk for abuse and addiction, which can||
3352|014|W|lead to overdose and death. Codeine may also cause severe,||
3352|015|W|possibly fatal, breathing problems. To lower your risk, your||
3352|016|W|doctor should have you take the smallest dose of codeine that||
3352|017|W|works, and take it for the shortest possible time. See also How||
3352|018|W|to Use section for more information about addiction.||
3352|019|W|   Ask your doctor or pharmacist if you should have medication||
3352|020|W|available to treat opioid overdose (such as naloxone, nalmefene).||
3352|021|W|Teach your family or household members about the signs of an||
3352|022|W|opioid overdose and how to treat it.||
3352|023|W|   The risk for severe breathing problems is higher when you||
3352|024|W|start this medication and after a dose increase, or if you take||
3352|025|W|the wrong dose/strength. Taking this medication with alcohol or||
3352|026|W|other drugs that can cause drowsiness or breathing problems may||
3352|027|W|cause very serious side effects, including death. Also, other||
3352|028|W|medications can affect the removal of codeine from your body,||
3352|029|W|which may affect how codeine works. Be sure you know how to take||
3352|030|W|codeine and what other drugs you should avoid taking with it. See||
3352|031|W|also Drug Interactions section. Get medical help right away if||
3352|032|W|any of these very serious side effects occur: slow/shallow||
3352|033|W|breathing, unusual lightheadedness, severe drowsiness/dizziness,||
3352|034|W|difficulty waking up.||
3352|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
3352|036|W|or abuse. If someone accidentally swallows this drug, get medical||
3352|037|W|help right away.||
3352|038|W|   Before using this medication, women of childbearing age should||
3352|039|W|talk with their doctor(s) about the risks and benefits. Tell your||
3352|040|W|doctor if you are pregnant or if you plan to become pregnant.||
3352|041|W|During pregnancy, this medication should be used only when||
3352|042|W|clearly needed. It may slightly increase the risk of birth||
3352|043|W|defects if used during the first two months of pregnancy. Also,||
3352|044|W|using it for a long time or in high doses near the expected||
3352|045|W|delivery date may harm the unborn baby. To lessen the risk, take||
3352|046|W|the smallest effective dose for the shortest possible time.||
3352|047|W|Babies born to mothers who use this drug for a long time may||
3352|048|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
3352|049|W|doctor right away if you notice any symptoms in your newborn baby||
3352|050|W|such as crying that doesn't stop, slow/shallow breathing,||
3352|051|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
3352|052|W|difficulty gaining weight.||
3352|053|W|   Children younger than 18 years should not use products that||
3352|054|W|contain codeine. Some children are more sensitive to codeine and||
3352|055|W|have had very serious (rarely fatal) breathing problems such as||
3352|056|W|slow/shallow breathing (see also Side Effects section). The risk||
3352|057|W|is greater in children who are obese or have breathing problems,||
3352|058|W|or after certain surgeries (including tonsil/adenoid removal).||
3352|059|W|Talk with your doctor or pharmacist about the risks and benefits||
3352|060|W|of this medication.||
3352|061|B|||
3352|062|U|USES:  See also Warning section.||
3352|063|U|   Codeine extended-release is a long-acting medication used to||
3352|064|U|help relieve mild to moderate pain. Codeine belongs to a class of||
3352|065|U|drugs known as opioid analgesics. It works in the brain to change||
3352|066|U|how your body feels and responds to pain.||
3352|067|U|   Do not use the extended-release form of codeine to relieve||
3352|068|U|pain that will go away in a few days. This medication is not for||
3352|069|U|occasional ("as needed") use.||
3352|070|B|||
3352|071|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3352|072|H|from your pharmacist before you start taking this medication and||
3352|073|H|each time you get a refill. If you have any questions, ask your||
3352|074|H|doctor or pharmacist.||
3352|075|H|   Take this medication by mouth on a regular schedule as||
3352|076|H|directed by your doctor, usually every 12 hours, but not as||
3352|077|H|needed for sudden (breakthrough) pain. Do not crush, chew, or||
3352|078|H|dissolve extended-release tablets. Doing so can release all of||
3352|079|H|the drug at once, increasing the risk of side effects. Also, do||
3352|080|H|not split the tablets unless they have a score line and your||
3352|081|H|doctor or pharmacist tells you to do so. Swallow the whole or||
3352|082|H|split tablet without crushing, chewing, or dissolving.||
3352|083|H|   You may take this drug with or without food. If you have||
3352|084|H|nausea, it may help to take this drug with food. Ask your doctor||
3352|085|H|or pharmacist about other ways to decrease nausea (such as lying||
3352|086|H|down for 1 to 2 hours with as little head movement as possible).||
3352|087|H|   The dosage is based on your medical condition and response to||
3352|088|H|treatment. Do not increase your dose or use this drug more often||
3352|089|H|or for longer than prescribed, because your risk of side effects||
3352|090|H|may increase. Properly stop the medication when so directed.||
3352|091|H|   Before you start using this medication, ask your doctor or||
3352|092|H|pharmacist if you should stop or change how you use your other||
3352|093|H|opioid medication(s). Other pain relievers (such as||
3352|094|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
3352|095|H|or pharmacist about using codeine safely with other drugs.||
3352|096|H|   Suddenly stopping this medication may cause withdrawal,||
3352|097|H|especially if you have used it for a long time or in high doses.||
3352|098|H|To prevent withdrawal, your doctor may lower your dose slowly.||
3352|099|H|Tell your doctor or pharmacist right away if you have any||
3352|100|H|withdrawal symptoms such as restlessness, mental/mood changes||
3352|101|H|(including anxiety, trouble sleeping, thoughts of suicide),||
3352|102|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
3352|103|H|aches, or sudden changes in behavior.||
3352|104|H|   When this medication is used for a long time, it may not work||
3352|105|H|as well. Talk with your doctor if this medication stops working||
3352|106|H|well.||
3352|107|H|   Though it helps many people, this medication may sometimes||
3352|108|H|cause addiction. This risk may be higher if you have a||
3352|109|H|mental/mood disorder or a substance use disorder (such as overuse||
3352|110|H|of or addiction to drugs/alcohol). Take this medication exactly||
3352|111|H|as prescribed to lower the risk of addiction. Ask your doctor or||
3352|112|H|pharmacist for more details.||
3352|113|H|   Tell your doctor if your pain does not get better or if it||
3352|114|H|gets worse, or if you have any new pain.||
3352|115|B|||
3352|116|S|SIDE EFFECTS:  See also Warning section.||
3352|117|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
3352|118|S|drowsiness, or sweating may occur. If any of these effects last||
3352|119|S|or get worse, tell your doctor or pharmacist promptly.||
3352|120|S|   To prevent constipation, eat dietary fiber, drink enough||
3352|121|S|water, and exercise. You may also need to take a laxative. Ask||
3352|122|S|your pharmacist which type of laxative is right for you.||
3352|123|S|   To reduce the risk of dizziness and lightheadedness, get up||
3352|124|S|slowly when rising from a sitting or lying position.||
3352|125|S|   Remember that this medication has been prescribed because your||
3352|126|S|doctor has judged that the benefit to you is greater than the||
3352|127|S|risk of side effects. Many people using this medication do not||
3352|128|S|have serious side effects.||
3352|129|S|   Tell your doctor right away if you have any serious side||
3352|130|S|effects, including: interrupted breathing during sleep (sleep||
3352|131|S|apnea), mental/mood changes (such as agitation, depression,||
3352|132|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
3352|133|S|fast/slow heartbeat, vision changes, signs of your adrenal glands||
3352|134|S|not working well (such as loss of appetite, unusual tiredness,||
3352|135|S|weight loss), trouble swallowing.||
3352|136|S|   Get medical help right away if you have any very serious side||
3352|137|S|effects, including: fainting, seizure.||
3352|138|S|   Codeine is changed into a strong opioid drug (morphine) in||
3352|139|S|your body. In some people, this change happens faster and more||
3352|140|S|completely than usual, which increases the risk of very serious||
3352|141|S|side effects. Get medical help right away if you notice any of||
3352|142|S|the following: slow/shallow breathing, severe||
3352|143|S|drowsiness/difficulty waking up, confusion.||
3352|144|S|   A very serious allergic reaction to this drug is rare.||
3352|145|S|However, get medical help right away if you notice any symptoms||
3352|146|S|of a serious allergic reaction, including: rash, itching/swelling||
3352|147|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3352|148|S|breathing.||
3352|149|S|   This is not a complete list of possible side effects. If you||
3352|150|S|notice other effects not listed above, contact your doctor or||
3352|151|S|pharmacist.||
3352|152|S|   In the US -||
3352|153|S|   Call your doctor for medical advice about side effects. You||
3352|154|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3352|155|S|www.fda.gov/medwatch.||
3352|156|S|   In Canada - Call your doctor for medical advice about side||
3352|157|S|effects. You may report side effects to Health Canada at||
3352|158|S|1-866-234-2345.||
3352|159|B|||
3352|160|P|PRECAUTIONS:  Before taking codeine, tell your doctor or||
3352|161|P|pharmacist if you are allergic to it; or to other opioid pain||
3352|162|P|medications (such as morphine); or if you have any other||
3352|163|P|allergies. This product may contain inactive ingredients, which||
3352|164|P|can cause allergic reactions or other problems. Talk to your||
3352|165|P|pharmacist for more details.||
3352|166|P|   Before using this medication, tell your doctor or pharmacist||
3352|167|P|your medical history, especially of: brain disorders (such as||
3352|168|P|head injury, tumor, seizures), breathing problems (such as||
3352|169|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
3352|170|P|gallbladder disease, kidney disease, liver disease, mental/mood||
3352|171|P|disorders (such as confusion, depression, thoughts of suicide),||
3352|172|P|personal or family history of a substance use disorder (such as||
3352|173|P|overuse of or addiction to drugs/alcohol), obesity,||
3352|174|P|stomach/intestinal problems (such as blockage, constipation,||
3352|175|P|diarrhea due to infection, paralytic ileus), disease of the||
3352|176|P|pancreas (pancreatitis), difficulty urinating (such as due to||
3352|177|P|enlarged prostate).||
3352|178|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
3352|179|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
3352|180|P|machinery, or do anything that needs alertness until you can do||
3352|181|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
3352|182|P|are using marijuana (cannabis).||
3352|183|P|   Before having surgery, tell your doctor or dentist about all||
3352|184|P|the products you use (including prescription drugs,||
3352|185|P|nonprescription drugs, and herbal products).||
3352|186|P|   Older adults may be more sensitive to the side effects of this||
3352|187|P|drug, especially confusion, dizziness, drowsiness, and||
3352|188|P|slow/shallow breathing.||
3352|189|P|   During pregnancy, this medication should be used only when||
3352|190|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
3352|191|P|benefits with your doctor. (See also Warning section.)||
3352|192|P|   This medication passes into breast milk and may have||
3352|193|P|undesirable effects on a nursing infant, such as unusual||
3352|194|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
3352|195|P|limpness. Consult your doctor before breastfeeding.||
3352|196|B|||
3352|197|I|DRUG INTERACTIONS:  See also Warning section.||
3352|198|I|   Drug interactions may change how your medications work or||
3352|199|I|increase your risk for serious side effects. This document does||
3352|200|I|not contain all possible drug interactions. Keep a list of all||
3352|201|I|the products you use (including prescription/nonprescription||
3352|202|I|drugs and herbal products) and share it with your doctor and||
3352|203|I|pharmacist. Do not start, stop, or change the dosage of any||
3352|204|I|medicines without your doctor's approval.||
3352|205|I|   Some products that may interact with this drug include:||
3352|206|I|certain pain medications (mixed opioid agonist-antagonists such||
3352|207|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
3352|208|I|samidorphan.||
3352|209|I|   The risk of serious side effects (such as slow/shallow||
3352|210|I|breathing, severe drowsiness/dizziness) may be increased if this||
3352|211|I|medication is taken with other products that may also cause||
3352|212|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
3352|213|I|if you are taking other products such as other opioid pain or||
3352|214|I|cough relievers (such as morphine, hydrocodone), alcohol,||
3352|215|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
3352|216|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
3352|217|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
3352|218|I|cetirizine, diphenhydramine).||
3352|219|I|   Check the labels on all your medicines (such as allergy or||
3352|220|I|cough-and-cold products) because they may contain ingredients||
3352|221|I|that cause drowsiness. Ask your pharmacist about using those||
3352|222|I|products safely.||
3352|223|I|   Other medications can affect the removal of codeine from your||
3352|224|I|body, which may affect how codeine works. Examples include azole||
3352|225|I|antifungals (such as ketoconazole), bupropion, fluoxetine,||
3352|226|I|macrolide antibiotics (such as erythromycin), paroxetine,||
3352|227|I|quinidine, rifamycins (such as rifabutin, rifampin), ritonavir,||
3352|228|I|certain drugs used to treat seizures (such as carbamazepine,||
3352|229|I|phenytoin), among others.||
3352|230|I|   This medication may interfere with certain lab tests (such as||
3352|231|I|amylase/lipase levels), possibly causing false test results. Make||
3352|232|I|sure lab personnel and all your doctors know you use this drug.||
3352|233|B|||
3352|234|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3352|235|O|as passing out or trouble breathing, give them naloxone or||
3352|236|O|nalmefene if available, then call 911. If the person is awake and||
3352|237|O|has no symptoms, call a poison control center right away. US||
3352|238|O|residents can call 1-800-222-1222. Canada residents can call||
3352|239|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
3352|240|O|breathing, slow heartbeat, severe drowsiness, coma.||
3352|241|B|||
3352|242|N|NOTES:  Do not share this medication with others. Sharing it is||
3352|243|N|against the law.||
3352|244|N|   This medication has been prescribed for your current condition||
3352|245|N|only. Do not use it later for another condition unless your||
3352|246|N|doctor directs you to do so. A different medication may be||
3352|247|N|necessary in that case.||
3352|248|B|||
3352|249|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3352|250|D|remember. If it is near the time of the next dose, skip the||
3352|251|D|missed dose. Take your next dose at the regular time. Do not||
3352|252|D|double the dose to catch up.||
3352|253|B|||
3352|254|R|STORAGE:  Store at room temperature away from light and moisture.||
3352|255|R|Do not store in the bathroom. Keep all medications away from||
3352|256|R|children and pets.||
3352|257|R|   Do not flush medications down the toilet or pour them into a||
3352|258|R|drain unless instructed to do so. Properly discard this product||
3352|259|R|when it is expired or no longer needed. Consult your pharmacist||
3352|260|R|or local waste disposal company.||
3352|261|B|||
3352|262|A|Information last revised August 2025.||
3352|263|A|Copyright(c) 2025 First Databank, Inc.||
3352|264|B|||
3372|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
3372|002|Z|does NOT have all possible information about this product. This||
3372|003|Z|information does not assure that this product is safe, effective,||
3372|004|Z|or appropriate for you. This information is not individual||
3372|005|Z|medical advice and does not substitute for the advice of your||
3372|006|Z|health care professional. Always ask your health care||
3372|007|Z|professional for complete information about this product and your||
3372|008|Z|specific health needs.||
3372|009|B|||
3372|010|T|LOSARTAN/HYDROCHLOROTHIAZIDE - ORAL||
3372|011|F|(low-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)||
3372|012|B|||
3372|013|C|COMMON BRAND NAME(S): Hyzaar||
3372|014|B|||
3372|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
3372|016|W|unborn baby if used during pregnancy. It is important to prevent||
3372|017|W|pregnancy while taking this medication. Consult your doctor for||
3372|018|W|more details and to discuss the use of reliable forms of birth||
3372|019|W|control while taking this medication. If you are planning||
3372|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
3372|021|W|your doctor right away.||
3372|022|B|||
3372|023|U|USES:  This drug is used to treat high blood pressure. It is also||
3372|024|U|used to lower the risk of strokes in patients with high blood||
3372|025|U|pressure and an enlarged heart. Lowering high blood pressure||
3372|026|U|helps prevent strokes, heart attacks, and kidney problems. This||
3372|027|U|product contains two medications: losartan and||
3372|028|U|hydrochlorothiazide. Losartan is an angiotensin receptor blocker||
3372|029|U|(ARB) and works by relaxing blood vessels so that blood can flow||
3372|030|U|more easily. Hydrochlorothiazide is a "water pill" (diuretic)||
3372|031|U|that causes you to make more urine, which helps your body get rid||
3372|032|U|of extra salt and water.||
3372|033|B|||
3372|034|V|OTHER USES:  This section contains uses of this drug that are not||
3372|035|V|listed in the approved professional labeling for the drug but||
3372|036|V|that may be prescribed by your health care professional. Use this||
3372|037|V|drug for a condition that is listed in this section only if it||
3372|038|V|has been so prescribed by your health care professional.||
3372|039|V|   This drug may also be used for heart failure.||
3372|040|B|||
3372|041|H|HOW TO USE:  Read the Patient Information Leaflet if available||
3372|042|H|from your pharmacist before you start taking||
3372|043|H|losartan/hydrochlorothiazide and each time you get a refill. If||
3372|044|H|you have any questions, ask your doctor or pharmacist.||
3372|045|H|   Take this medication by mouth with or without food as directed||
3372|046|H|by your doctor, usually once daily. If this medication causes you||
3372|047|H|to urinate more often, it is best to take it at least 4 hours||
3372|048|H|before your bedtime to prevent having to get up to urinate.||
3372|049|H|   If you also take certain drugs to lower your cholesterol (bile||
3372|050|H|acid-binding resins such as cholestyramine or colestipol), take||
3372|051|H|losartan/hydrochlorothiazide at least 4 hours before or at least||
3372|052|H|4 to 6 hours after these medications.||
3372|053|H|   The dosage is based on your medical condition and response to||
3372|054|H|treatment.||
3372|055|H|   Use this medication regularly to get the most benefit from it.||
3372|056|H|To help you remember, take it at the same time each day. Keep||
3372|057|H|taking this medication even if you feel well. Most people with||
3372|058|H|high blood pressure do not feel sick.||
3372|059|H|   Tell your doctor if your condition does not get better or if||
3372|060|H|it gets worse (for example, your blood pressure readings remain||
3372|061|H|high or increase).||
3372|062|B|||
3372|063|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
3372|064|S|body adjusts to the medication. If any of these effects last or||
3372|065|S|get worse, tell your doctor or pharmacist promptly.||
3372|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
3372|067|S|slowly when rising from a sitting or lying position.||
3372|068|S|   Remember that this medication has been prescribed because your||
3372|069|S|doctor has judged that the benefit to you is greater than the||
3372|070|S|risk of side effects. Many people using this medication do not||
3372|071|S|have serious side effects.||
3372|072|S|   This product may cause dehydration and electrolyte imbalance.||
3372|073|S|Tell your doctor right away if you have any symptoms of||
3372|074|S|dehydration or electrolyte imbalance, including unusual dry||
3372|075|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
3372|076|S|heartbeat, or confusion.||
3372|077|S|   Tell your doctor right away if you have any serious side||
3372|078|S|effects, including: fainting, decrease in vision, eye pain, signs||
3372|079|S|of kidney problems (such as change in the amount of urine).||
3372|080|S|   A very serious allergic reaction to this drug is rare.||
3372|081|S|However, get medical help right away if you notice any symptoms||
3372|082|S|of a serious allergic reaction, including: rash, itching/swelling||
3372|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
3372|084|S|breathing.||
3372|085|S|   This is not a complete list of possible side effects. If you||
3372|086|S|notice other effects not listed above, contact your doctor or||
3372|087|S|pharmacist.||
3372|088|S|   In the US -||
3372|089|S|   Call your doctor for medical advice about side effects. You||
3372|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
3372|091|S|www.fda.gov/medwatch.||
3372|092|S|   In Canada - Call your doctor for medical advice about side||
3372|093|S|effects. You may report side effects to Health Canada at||
3372|094|S|1-866-234-2345.||
3372|095|B|||
3372|096|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
3372|097|P|pharmacist if you are allergic to losartan or||
3372|098|P|hydrochlorothiazide; or if you have any other allergies. This||
3372|099|P|product may contain inactive ingredients, which can cause||
3372|100|P|allergic reactions or other problems. Talk to your pharmacist for||
3372|101|P|more details.||
3372|102|P|   Before using this medication, tell your doctor or pharmacist||
3372|103|P|your medical history, especially of: gout, kidney disease, liver||
3372|104|P|disease, lupus, dehydration, high level of potassium in the||
3372|105|P|blood, skin cancer.||
3372|106|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
3372|107|P|can make you more dizzy. Do not drive, use machinery, or do||
3372|108|P|anything that needs alertness until you can do it safely. Limit||
3372|109|P|alcoholic beverages. Talk to your doctor if you are using||
3372|110|P|marijuana (cannabis).||
3372|111|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
3372|112|P|and cause you to feel lightheaded. Tell your doctor if you have||
3372|113|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
3372|114|P|of fluids unless your doctor tells you not to.||
3372|115|P|   If you have diabetes, this product may affect your blood||
3372|116|P|sugar. Check your blood sugar regularly as directed and share the||
3372|117|P|results with your doctor. Your doctor may need to adjust your||
3372|118|P|diabetes medication, exercise program, or diet.||
3372|119|P|   This medication may make you more sensitive to the sun. It may||
3372|120|P|also increase your risk for skin cancer, especially if you take||
3372|121|P|it for a long time. Limit your time in the sun. Avoid tanning||
3372|122|P|booths and sunlamps. Use sunscreen and wear protective clothing||
3372|123|P|when outdoors. Tell your doctor right away if you get sunburned,||
3372|124|P|have skin blisters/redness, or notice new or changed moles/skin||
3372|125|P|lesions.||
3372|126|P|   This product may affect your potassium levels. Before using||
3372|127|P|potassium supplements or salt substitutes that contain potassium,||
3372|128|P|consult your doctor or pharmacist.||
3372|129|P|   Before having surgery, tell your doctor or dentist about all||
3372|130|P|the products you use (including prescription drugs,||
3372|131|P|nonprescription drugs, and herbal products).||
3372|132|P|   Older adults may be more sensitive to the side effects of this||
3372|133|P|drug, especially dizziness and change in the amount of urine||
3372|134|P|(kidney problems).||
3372|135|P|   Tell your doctor if you are pregnant or plan to become||
3372|136|P|pregnant. You should not become pregnant while using this||
3372|137|P|product. Losartan may harm an unborn baby. If you become||
3372|138|P|pregnant, talk to your doctor right away about the risks and||
3372|139|P|benefits of this medication. (See also Warning section.)||
3372|140|P|   It is unknown if losartan passes into breast milk.||
3372|141|P|Hydrochlorothiazide passes into breast milk, but is unlikely to||
3372|142|P|harm a nursing infant. Consult your doctor before breastfeeding.||
3372|143|B|||
3372|144|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
3372|145|I|   Drug interactions may change how your medications work or||
3372|146|I|increase your risk for serious side effects. This document does||
3372|147|I|not contain all possible drug interactions. Keep a list of all||
3372|148|I|the products you use (including prescription/nonprescription||
3372|149|I|drugs and herbal products) and share it with your doctor and||
3372|150|I|pharmacist. Do not start, stop, or change the dosage of any||
3372|151|I|medicines without your doctor's approval.||
3372|152|I|   Some products that may interact with this drug include:||
3372|153|I|aliskiren, dofetilide, lithium, drugs that may increase the level||
3372|154|I|of potassium in the blood (such as sparsentan, ACE inhibitors||
3372|155|I|including benazepril/lisinopril, birth control pills containing||
3372|156|I|drospirenone).||
3372|157|I|   Some products have ingredients that could raise your blood||
3372|158|I|pressure or worsen your heart failure. Tell your pharmacist what||
3372|159|I|products you are using, and ask how to use them safely||
3372|160|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
3372|161|I|ibuprofen/naproxen).||
3372|162|I|   This medication may interfere with certain lab tests (such as||
3372|163|I|parathyroid function), possibly causing false test results. Make||
3372|164|I|sure lab personnel and all your doctors know you use this drug.||
3372|165|B|||
3372|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
3372|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
3372|168|O|poison control center right away. US residents can call||
3372|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
3372|170|O|Symptoms of overdose may include: severe dizziness, fainting.||
3372|171|B|||
3372|172|N|NOTES:  Do not share this medication with others.||
3372|173|N|   Lifestyle changes such as stress reduction programs, exercise,||
3372|174|N|and dietary changes may increase the effectiveness of this||
3372|175|N|medicine. Talk to your doctor or pharmacist about lifestyle||
3372|176|N|changes that might benefit you.||
3372|177|N|   Lab and/or medical tests (such as kidney function, potassium||
3372|178|N|levels, skin exams, cholesterol levels) should be done while you||
3372|179|N|are taking this medication. Keep all medical and lab||
3372|180|N|appointments. Consult your doctor for more details.||
3372|181|N|   Check your blood pressure regularly while taking this||
3372|182|N|medication. Learn how to monitor your own blood pressure, and||
3372|183|N|share the results with your doctor.||
3372|184|B|||
3372|185|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
3372|186|D|remember. If it is near the time of the next dose, skip the||
3372|187|D|missed dose. Take your next dose at the regular time. Do not||
3372|188|D|double the dose to catch up.||
3372|189|B|||
3372|190|R|STORAGE:  Store at room temperature away from light and moisture.||
3372|191|R|Do not store in the bathroom. Keep all medications away from||
3372|192|R|children and pets.||
3372|193|R|   Do not flush medications down the toilet or pour them into a||
3372|194|R|drain unless instructed to do so. Properly discard this product||
3372|195|R|when it is expired or no longer needed. Consult your pharmacist||
3372|196|R|or local waste disposal company.||
3372|197|B|||
3372|198|A|Information last revised March 2025.||
3372|199|A|Copyright(c) 2025 First Databank, Inc.||
3372|200|B|||
4004|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4004|002|Z|does NOT have all possible information about this product. This||
4004|003|Z|information does not assure that this product is safe, effective,||
4004|004|Z|or appropriate for you. This information is not individual||
4004|005|Z|medical advice and does not substitute for the advice of your||
4004|006|Z|health care professional. Always ask your health care||
4004|007|Z|professional for complete information about this product and your||
4004|008|Z|specific health needs.||
4004|009|B|||
4004|010|T|HYOSCYAMINE - SUBLINGUAL||
4004|011|F|(hi-oh-SYE-uh-meen)||
4004|012|B|||
4004|013|C|COMMON BRAND NAME(S): Levsin-SL||
4004|014|B|||
4004|015|U|USES:  Hyoscyamine is used to treat a variety of||
4004|016|U|stomach/intestinal problems such as cramps and irritable bowel||
4004|017|U|syndrome. It is also used to treat other conditions such as||
4004|018|U|bladder and bowel control problems, cramping pain caused by||
4004|019|U|kidney stones and gallstones, and Parkinson's disease. In||
4004|020|U|addition, it is used to decrease side effects of certain||
4004|021|U|medications (drugs used to treat myasthenia gravis) and||
4004|022|U|insecticides.||
4004|023|U|   This medication works by decreasing acid production in the||
4004|024|U|stomach, slowing down the natural movements of the gut, and||
4004|025|U|relaxing muscles in many organs (such as the stomach, intestines,||
4004|026|U|bladder, kidney, gallbladder). Hyoscyamine also lessens the||
4004|027|U|amount of certain body fluids (such as saliva, sweat). This||
4004|028|U|medication belongs to a class of drugs known as||
4004|029|U|anticholinergics/antispasmodics.||
4004|030|B|||
4004|031|H|HOW TO USE:  Place this medication under the tongue and allow it||
4004|032|H|to dissolve. This medication may also be swallowed whole or||
4004|033|H|chewed. It may be taken with or without meals. Take it as||
4004|034|H|prescribed by your doctor.||
4004|035|H|   The dosage is based on your medical condition and response to||
4004|036|H|treatment. Do not increase your dose or take it more often than||
4004|037|H|prescribed without consulting your doctor. Adults and children 12||
4004|038|H|years and older should not take more than 1.5 milligrams in 24||
4004|039|H|hours. Children aged 2 to 12 years should not take more than 0.75||
4004|040|H|milligrams in 24 hours. Ask your doctor or pharmacist for more||
4004|041|H|information.||
4004|042|H|   Antacids lower the absorption of hyoscyamine. If you use||
4004|043|H|antacids, take them after meals and take hyoscyamine before||
4004|044|H|meals; or take antacids at least 1 hour after taking hyoscyamine.||
4004|045|H|   Drink plenty of fluids while taking this medication unless||
4004|046|H|your doctor directs you otherwise.||
4004|047|H|   Tell your doctor if your condition lasts or gets worse.||
4004|048|B|||
4004|049|S|SIDE EFFECTS:  Dizziness, drowsiness, blurred vision, dry mouth,||
4004|050|S|headache, trouble sleeping, constipation, flushing, dry skin, and||
4004|051|S|decreased sweating may occur. If any of these effects last or get||
4004|052|S|worse, tell your doctor or pharmacist promptly.||
4004|053|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
4004|054|S|chips, chew (sugarless) gum, drink water or use a saliva||
4004|055|S|substitute.||
4004|056|S|   Remember that this medication has been prescribed because your||
4004|057|S|doctor has judged that the benefit to you is greater than the||
4004|058|S|risk of side effects. Many people using this medication do not||
4004|059|S|have serious side effects.||
4004|060|S|   Tell your doctor right away if you have any serious side||
4004|061|S|effects, including: mental/mood changes (such as confusion,||
4004|062|S|unusual excitement), fast/irregular heartbeat, difficulty||
4004|063|S|urinating, decreased sexual ability, loss of coordination,||
4004|064|S|trouble speaking, vomiting.||
4004|065|S|   Get medical help right away if you have any very serious side||
4004|066|S|effects, including: eye pain/swelling/redness, vision changes||
4004|067|S|(such as seeing rainbows around lights at night).||
4004|068|S|   A very serious allergic reaction to this drug is rare.||
4004|069|S|However, get medical help right away if you notice any symptoms||
4004|070|S|of a serious allergic reaction, including: rash, itching/swelling||
4004|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4004|072|S|breathing.||
4004|073|S|   This is not a complete list of possible side effects. If you||
4004|074|S|notice other effects not listed above, contact your doctor or||
4004|075|S|pharmacist.||
4004|076|S|   In the US -||
4004|077|S|   Call your doctor for medical advice about side effects. You||
4004|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4004|079|S|www.fda.gov/medwatch.||
4004|080|S|   In Canada - Call your doctor for medical advice about side||
4004|081|S|effects. You may report side effects to Health Canada at||
4004|082|S|1-866-234-2345.||
4004|083|B|||
4004|084|P|PRECAUTIONS:  Before taking hyoscyamine, tell your doctor or||
4004|085|P|pharmacist if you are allergic to it; or to atropine; or if you||
4004|086|P|have any other allergies. This product may contain inactive||
4004|087|P|ingredients, which can cause allergic reactions or other||
4004|088|P|problems. Talk to your pharmacist for more details.||
4004|089|P|   Before using this medication, tell your doctor or pharmacist||
4004|090|P|your medical history, especially of: personal or family history||
4004|091|P|of glaucoma (angle-closure type), enlarged prostate, urinary||
4004|092|P|blockage problems, certain stomach/intestinal problems (such as||
4004|093|P|slow gut, blockage, severe ulcerative colitis, infection),||
4004|094|P|overactive thyroid, heart problems (such as coronary heart||
4004|095|P|disease, heart failure, fast heartbeat, arrhythmias), high blood||
4004|096|P|pressure, kidney disease, heartburn problems (acid reflux, hiatal||
4004|097|P|hernia), certain nervous system problem (autonomic neuropathy),||
4004|098|P|myasthenia gravis.||
4004|099|P|   Contact lens wearers may need to use wetting eye drops since||
4004|100|P|this medication can cause dry eyes.||
4004|101|P|   This drug may make you dizzy or drowsy or blur your vision.||
4004|102|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
4004|103|P|drowsy. Do not drive, use machinery, or do anything that needs||
4004|104|P|alertness or clear vision until you can do it safely. Limit||
4004|105|P|alcoholic beverages. Talk to your doctor if you are using||
4004|106|P|marijuana (cannabis).||
4004|107|P|   Before having surgery, tell your doctor or dentist about all||
4004|108|P|the products you use (including prescription drugs,||
4004|109|P|nonprescription drugs, and herbal products).||
4004|110|P|   This drug may make you sweat less, making you more likely to||
4004|111|P|get heat stroke. Avoid doing things that may cause you to||
4004|112|P|overheat, such as hard work or exercise in hot weather, or using||
4004|113|P|hot tubs. When the weather is hot, drink a lot of fluids and||
4004|114|P|dress lightly. If you overheat, quickly look for a place to cool||
4004|115|P|down and rest. Get medical help right away if you have a fever||
4004|116|P|that does not go away, mental/mood changes, headache, or||
4004|117|P|dizziness.||
4004|118|P|   Older adults may be more sensitive to the side effects of this||
4004|119|P|drug, especially confusion, drowsiness, unusual excitement,||
4004|120|P|constipation, and difficulty urinating. Confusion and drowsiness||
4004|121|P|can increase the risk of falling.||
4004|122|P|   Children may be more sensitive to the side effects of this||
4004|123|P|drug.||
4004|124|P|   During pregnancy, hyoscyamine should be used only when clearly||
4004|125|P|needed. Discuss the risks and benefits with your doctor.||
4004|126|P|   This drug passes into breast milk. Consult your doctor before||
4004|127|P|breastfeeding.||
4004|128|B|||
4004|129|I|DRUG INTERACTIONS:  See also How to Use section.||
4004|130|I|   Drug interactions may change how your medications work or||
4004|131|I|increase your risk for serious side effects. This document does||
4004|132|I|not contain all possible drug interactions. Keep a list of all||
4004|133|I|the products you use (including prescription/nonprescription||
4004|134|I|drugs and herbal products) and share it with your doctor and||
4004|135|I|pharmacist. Do not start, stop, or change the dosage of any||
4004|136|I|medicines without your doctor's approval.||
4004|137|I|   Some products that may interact with this drug are: certain||
4004|138|I|azole anti-fungal drugs (ketoconazole, itraconazole),||
4004|139|I|bisphosphonate drugs (such as alendronate, risedronate),||
4004|140|I|corticosteroids (such as prednisone), digoxin (slow-dissolving||
4004|141|I|tablets), potassium tablets/capsules, pramlintide.||
4004|142|I|   Tell your doctor or pharmacist if you are taking other||
4004|143|I|products that cause drowsiness such as opioid pain or cough||
4004|144|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4004|145|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4004|146|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4004|147|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
4004|148|I|diphenhydramine).||
4004|149|I|   Check the labels on all your medicines (such as allergy or||
4004|150|I|cough-and-cold products) because they may contain ingredients||
4004|151|I|that cause drowsiness. Ask your pharmacist about using those||
4004|152|I|products safely.||
4004|153|I|   This medication may interfere with certain lab tests, possibly||
4004|154|I|causing false test results. Make sure lab personnel and all your||
4004|155|I|doctors know you use this drug.||
4004|156|B|||
4004|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4004|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4004|159|O|poison control center right away. US residents can call||
4004|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4004|161|O|Symptoms of overdose may include hot/dry skin, fever, unusual||
4004|162|O|excitement, fast/irregular heartbeat, seizures.||
4004|163|B|||
4004|164|N|NOTES:  Do not share this medication with others.||
4004|165|N|   Management of digestive disorders may include lifestyle||
4004|166|N|changes such as stress reduction programs, exercise, stopping||
4004|167|N|smoking, and dietary changes to increase the effectiveness of||
4004|168|N|this medicine. Talk to your doctor or pharmacist about lifestyle||
4004|169|N|changes that might benefit you.||
4004|170|B|||
4004|171|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4004|172|D|remember. If it is near the time of the next dose, skip the||
4004|173|D|missed dose. Take your next dose at the regular time. Do not||
4004|174|D|double the dose to catch up.||
4004|175|B|||
4004|176|R|STORAGE:  Store at room temperature away from light and moisture.||
4004|177|R|Do not store in the bathroom. Keep all medications away from||
4004|178|R|children and pets.||
4004|179|R|   Do not flush medications down the toilet or pour them into a||
4004|180|R|drain unless instructed to do so. Properly discard this product||
4004|181|R|when it is expired or no longer needed. Consult your pharmacist||
4004|182|R|or local waste disposal company.||
4004|183|B|||
4004|184|A|Information last revised October 2025.||
4004|185|A|Copyright(c) 2025 First Databank, Inc.||
4004|186|B|||
4005|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4005|002|Z|does NOT have all possible information about this product. This||
4005|003|Z|information does not assure that this product is safe, effective,||
4005|004|Z|or appropriate for you. This information is not individual||
4005|005|Z|medical advice and does not substitute for the advice of your||
4005|006|Z|health care professional. Always ask your health care||
4005|007|Z|professional for complete information about this product and your||
4005|008|Z|specific health needs.||
4005|009|B|||
4005|010|T|CLONAZEPAM DISINTEGRATING TABLET - ORAL||
4005|011|F|(klo-NAY-zeh-pam)||
4005|012|B|||
4005|013|C|COMMON BRAND NAME(S): Klonopin||
4005|014|B|||
4005|015|W|WARNING:  Clonazepam has a risk for abuse and addiction, which||
4005|016|W|can lead to overdose and death. Taking this medication with||
4005|017|W|alcohol or other drugs that can cause drowsiness or breathing||
4005|018|W|problems (especially opioid medications such as codeine,||
4005|019|W|hydrocodone) may cause very serious side effects, including||
4005|020|W|death. To lower your risk, your doctor should have you take the||
4005|021|W|smallest dose of clonazepam that works, and take it for the||
4005|022|W|shortest possible time. Be sure you know how to take clonazepam||
4005|023|W|and what other drugs you should avoid taking with it. See also||
4005|024|W|Drug Interactions section. Get medical help right away if any of||
4005|025|W|these very serious side effects occur: slow/shallow breathing,||
4005|026|W|unusual lightheadedness, severe drowsiness/dizziness, difficulty||
4005|027|W|waking up.||
4005|028|W|   Suddenly stopping this medication may cause serious (possibly||
4005|029|W|fatal) withdrawal, especially if you have used it for a long time||
4005|030|W|or in high doses. To prevent withdrawal, your doctor may lower||
4005|031|W|your dose slowly. Tell your doctor or pharmacist right away if||
4005|032|W|you have any withdrawal symptoms such as headaches, trouble||
4005|033|W|sleeping, restlessness, hallucinations/confusion, depression,||
4005|034|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
4005|035|W|to months.||
4005|036|B|||
4005|037|U|USES:  Clonazepam is used to prevent and control seizures. This||
4005|038|U|medication is known as an anticonvulsant or antiepileptic drug.||
4005|039|U|It is also used to treat panic attacks. Clonazepam works by||
4005|040|U|calming your brain and nerves. It belongs to a class of drugs||
4005|041|U|called benzodiazepines.||
4005|042|B|||
4005|043|V|OTHER USES:  This section contains uses of this drug that are not||
4005|044|V|listed in the approved professional labeling for the drug but||
4005|045|V|that may be prescribed by your health care professional. Use this||
4005|046|V|drug for a condition that is listed in this section only if it||
4005|047|V|has been so prescribed by your health care professional.||
4005|048|V|   This drug may also be used for anxiety disorders or movement||
4005|049|V|disorders (such as tremors, akathisia).||
4005|050|B|||
4005|051|H|HOW TO USE:  See also Warning section.||
4005|052|H|   Read the Medication Guide provided by your pharmacist before||
4005|053|H|you start taking clonazepam and each time you get a refill. If||
4005|054|H|you have any questions, ask your doctor or pharmacist.||
4005|055|H|   Take this medication by mouth as directed by your doctor,||
4005|056|H|usually 2 or 3 times daily.||
4005|057|H|   Do not remove the tablet from its pouch until you are ready to||
4005|058|H|take it. Dry your hands before handling the medication. Open the||
4005|059|H|pouch and peel back the foil layer. Do not push the tablet||
4005|060|H|through the foil because it may get damaged. Place the dose in||
4005|061|H|your mouth where it will quickly dissolve. You can then swallow||
4005|062|H|it with saliva or water. You do not need to take this medication||
4005|063|H|with water.||
4005|064|H|   The dosage is based on your medical condition, age, and||
4005|065|H|response to treatment. Children's dosage is also based on weight.||
4005|066|H|Older adults usually start with a lower dose to decrease the risk||
4005|067|H|of side effects. Do not increase your dose, take it more often,||
4005|068|H|or take it for a longer time than directed.||
4005|069|H|   Take this medication regularly to get the most benefit from||
4005|070|H|it. To help you remember, take it at the same times each day.||
4005|071|H|   Do not stop taking this medication without consulting your||
4005|072|H|doctor. Some conditions may become worse when this drug is||
4005|073|H|suddenly stopped. Your dose may need to be gradually decreased.||
4005|074|H|   When this medication is used for a long time, it may not work||
4005|075|H|as well. Talk with your doctor if this medication stops working||
4005|076|H|well.||
4005|077|H|   Though it helps many people, this medication may sometimes||
4005|078|H|cause addiction. This risk may be higher if you have a substance||
4005|079|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
4005|080|H|Take this medication exactly as prescribed to lower the risk of||
4005|081|H|addiction. Ask your doctor or pharmacist for more details.||
4005|082|H|   If you have several different types of seizure disorders, you||
4005|083|H|may experience a worsening of seizures when you first start using||
4005|084|H|clonazepam. Consult your doctor right away if this happens. Your||
4005|085|H|doctor may need to add or adjust the dose of your other||
4005|086|H|medications to control the seizures.||
4005|087|H|   Tell your doctor if your condition lasts or gets worse.||
4005|088|B|||
4005|089|S|SIDE EFFECTS:  See also Warning section.||
4005|090|S|   Drowsiness, dizziness, tiredness, loss of coordination, or||
4005|091|S|increased saliva production may occur. If any of these effects||
4005|092|S|last or get worse, tell your doctor or pharmacist promptly.||
4005|093|S|   Remember that this medication has been prescribed because your||
4005|094|S|doctor has judged that the benefit to you is greater than the||
4005|095|S|risk of side effects. Many people using this medication do not||
4005|096|S|have serious side effects.||
4005|097|S|   A small number of people who take anticonvulsants for any||
4005|098|S|condition (such as seizures, bipolar disorder, pain) may||
4005|099|S|experience depression, suicidal thoughts/attempts, or other||
4005|100|S|mental/mood problems. Tell your doctor right away if you or your||
4005|101|S|family/caregiver notice any unusual/sudden changes in your mood,||
4005|102|S|thoughts, or behavior, including: confusion, memory problems,||
4005|103|S|signs of depression, suicidal thoughts/attempts, thoughts about||
4005|104|S|harming yourself.||
4005|105|S|   A very serious allergic reaction to this drug is rare.||
4005|106|S|However, get medical help right away if you notice any symptoms||
4005|107|S|of a serious allergic reaction, including: rash, itching/swelling||
4005|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4005|109|S|breathing.||
4005|110|S|   This is not a complete list of possible side effects. If you||
4005|111|S|notice other effects not listed above, contact your doctor or||
4005|112|S|pharmacist.||
4005|113|S|   In the US -||
4005|114|S|   Call your doctor for medical advice about side effects. You||
4005|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4005|116|S|www.fda.gov/medwatch.||
4005|117|S|   In Canada - Call your doctor for medical advice about side||
4005|118|S|effects. You may report side effects to Health Canada at||
4005|119|S|1-866-234-2345.||
4005|120|B|||
4005|121|P|PRECAUTIONS:  Before taking clonazepam, tell your doctor or||
4005|122|P|pharmacist if you are allergic to it; or to other benzodiazepines||
4005|123|P|(such as diazepam, lorazepam); or if you have any other||
4005|124|P|allergies. This product may contain inactive ingredients, which||
4005|125|P|can cause allergic reactions or other problems. Talk to your||
4005|126|P|pharmacist for more details.||
4005|127|P|   Before using this medication, tell your doctor or pharmacist||
4005|128|P|your medical history, especially of: a certain type of eye||
4005|129|P|problem (narrow angle glaucoma), a certain blood disorder||
4005|130|P|(porphyria), liver disease, kidney disease, lung/breathing||
4005|131|P|problems, mental/mood problems (such as depression, thoughts of||
4005|132|P|suicide), personal or family history of a substance use disorder||
4005|133|P|(such as overuse of or addiction to drugs/alcohol).||
4005|134|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4005|135|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4005|136|P|machinery, or do anything that needs alertness until you can do||
4005|137|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
4005|138|P|are using marijuana (cannabis).||
4005|139|P|   Before having surgery, tell your doctor or dentist about all||
4005|140|P|the products you use (including prescription drugs,||
4005|141|P|nonprescription drugs, and herbal products).||
4005|142|P|   For children, the long-term effects on physical and||
4005|143|P|mental/behavioral development are uncertain and may not be seen||
4005|144|P|until after many years. Discuss the risks and benefits of||
4005|145|P|treatment with clonazepam with your doctor.||
4005|146|P|   Older adults may be more sensitive to the effects of this||
4005|147|P|drug, especially drowsiness and confusion. These side effects can||
4005|148|P|increase the risk of falling.||
4005|149|P|   During pregnancy, this medication should be used only when||
4005|150|P|clearly needed. It may harm an unborn baby. Newborn babies of||
4005|151|P|mothers who use this medication late in pregnancy may have||
4005|152|P|symptoms such as slow/shallow breathing, nonstop crying, shaking,||
4005|153|P|or trouble feeding. However, since untreated seizures are a||
4005|154|P|serious condition that can harm both a pregnant woman and her||
4005|155|P|unborn baby, do not stop taking this medication unless directed||
4005|156|P|by your doctor. If you are planning pregnancy, become pregnant,||
4005|157|P|or think you may be pregnant, talk to your doctor right away||
4005|158|P|about the risks and benefits of this medication.||
4005|159|P|   This drug passes into breast milk and may have undesirable||
4005|160|P|effects on a nursing infant. Consult your doctor before||
4005|161|P|breastfeeding.||
4005|162|B|||
4005|163|I|DRUG INTERACTIONS:  See also Warning section.||
4005|164|I|   Drug interactions may change how your medications work or||
4005|165|I|increase your risk for serious side effects. This document does||
4005|166|I|not contain all possible drug interactions. Keep a list of all||
4005|167|I|the products you use (including prescription/nonprescription||
4005|168|I|drugs and herbal products) and share it with your doctor and||
4005|169|I|pharmacist. Do not start, stop, or change the dosage of any||
4005|170|I|medicines without your doctor's approval.||
4005|171|I|   Products that may interact with this drug include: orlistat,||
4005|172|I|sodium oxybate.||
4005|173|I|   The risk of serious side effects (such as slow/shallow||
4005|174|I|breathing, severe drowsiness/dizziness) may be increased if this||
4005|175|I|medication is taken with other products that may also cause||
4005|176|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
4005|177|I|if you are taking other products such as opioid pain or cough||
4005|178|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4005|179|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4005|180|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4005|181|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
4005|182|I|diphenhydramine).||
4005|183|I|   Check the labels on all your medicines (such as allergy or||
4005|184|I|cough-and-cold products) because they may contain ingredients||
4005|185|I|that cause drowsiness. Ask your pharmacist about using those||
4005|186|I|products safely.||
4005|187|B|||
4005|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4005|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4005|190|O|poison control center right away. US residents can call||
4005|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4005|192|O|Symptoms of overdose may include: severe drowsiness, confusion,||
4005|193|O|loss of consciousness, slowed/decreased reflexes.||
4005|194|B|||
4005|195|N|NOTES:  Do not share this medication with others. Sharing it is||
4005|196|N|against the law.||
4005|197|N|   Lab and/or medical tests (such as liver function, complete||
4005|198|N|blood count) should be done while you are taking this medication.||
4005|199|N|Keep all medical and lab appointments. Consult your doctor for||
4005|200|N|more details.||
4005|201|B|||
4005|202|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4005|203|D|remember. If it is near the time of the next dose, skip the||
4005|204|D|missed dose. Take your next dose at the regular time. Do not||
4005|205|D|double the dose to catch up.||
4005|206|B|||
4005|207|R|STORAGE:  Store at room temperature away from light and moisture.||
4005|208|R|Do not store in the bathroom. Keep all medications away from||
4005|209|R|children and pets.||
4005|210|R|   Do not flush medications down the toilet or pour them into a||
4005|211|R|drain unless instructed to do so. Properly discard this product||
4005|212|R|when it is expired or no longer needed. Consult your pharmacist||
4005|213|R|or local waste disposal company.||
4005|214|B|||
4005|215|M|MEDICAL ALERT:  Your condition can cause complications in a||
4005|216|M|medical emergency. For information about enrolling in MedicAlert,||
4005|217|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4005|218|B|||
4005|219|A|Information last revised September 2024.||
4005|220|A|Copyright(c) 2025 First Databank, Inc.||
4005|221|B|||
4006|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4006|002|Z|does NOT have all possible information about this product. This||
4006|003|Z|information does not assure that this product is safe, effective,||
4006|004|Z|or appropriate for you. This information is not individual||
4006|005|Z|medical advice and does not substitute for the advice of your||
4006|006|Z|health care professional. Always ask your health care||
4006|007|Z|professional for complete information about this product and your||
4006|008|Z|specific health needs.||
4006|009|B|||
4006|010|T|NITRAZEPAM - ORAL||
4006|011|F|(nye-TRAY-zeh-pam)||
4006|012|B|||
4006|013|W|WARNING:  Nitrazepam has a risk for abuse and addiction, which||
4006|014|W|can lead to overdose and death. Taking this medication with||
4006|015|W|alcohol or other drugs that can cause drowsiness or breathing||
4006|016|W|problems (especially opioid medications such as codeine,||
4006|017|W|hydrocodone) may cause very serious side effects, including||
4006|018|W|death. To lower your risk, your doctor should have you take the||
4006|019|W|smallest dose of nitrazepam that works, and take it for the||
4006|020|W|shortest possible time. Be sure you know how to take nitrazepam||
4006|021|W|and what other drugs you should avoid taking with it. See also||
4006|022|W|Drug Interactions section. Get medical help right away if any of||
4006|023|W|these very serious side effects occur: slow/shallow breathing,||
4006|024|W|unusual lightheadedness, severe drowsiness/dizziness, difficulty||
4006|025|W|waking up.||
4006|026|W|   Suddenly stopping this medication may cause serious (possibly||
4006|027|W|fatal) withdrawal, especially if you have used it for a long time||
4006|028|W|or in high doses. To prevent withdrawal, your doctor may lower||
4006|029|W|your dose slowly. Tell your doctor or pharmacist right away if||
4006|030|W|you have any withdrawal symptoms such as headaches, trouble||
4006|031|W|sleeping, restlessness, hallucinations/confusion, depression,||
4006|032|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
4006|033|W|to months.||
4006|034|B|||
4006|035|U|USES:  This medication is used by adults for the short-term||
4006|036|U|treatment of trouble sleeping (insomnia). It may help you fall||
4006|037|U|asleep faster and decrease the number of times you awaken during||
4006|038|U|the night. It may also help you sleep for a longer time.||
4006|039|U|Nitrazepam is also used by children and infants to treat a||
4006|040|U|certain type of seizure (myoclonic).||
4006|041|U|   This medication belongs to a class of drugs called||
4006|042|U|benzodiazepines, which act on the brain to produce a calming||
4006|043|U|effect. It works by enhancing the effects of a certain natural||
4006|044|U|chemical in the body (GABA).||
4006|045|B|||
4006|046|H|HOW TO USE:  See also Warning section.||
4006|047|H|   To treat insomnia, take this medication by mouth with or||
4006|048|H|without food as directed by your doctor, usually before bedtime.||
4006|049|H|This medication can be chewed or dissolved in liquid if you are||
4006|050|H|unable to swallow it whole.||
4006|051|H|   Do not use this medication if you have less than 7 to 8 hours||
4006|052|H|to sleep. Doing so increases the risk of daytime drowsiness and||
4006|053|H|temporary memory loss.||
4006|054|H|   To treat seizures in infants and children, give the medication||
4006|055|H|by mouth as directed by your doctor, usually 3 times a day.||
4006|056|H|   The dosage is based on your medical condition and response to||
4006|057|H|treatment. Nitrazepam is not usually used for more than 7 to 10||
4006|058|H|days when treating insomnia. Long-term use can cause the||
4006|059|H|medication to build up in your body, increase side effects, and||
4006|060|H|cause dependence. It can make your insomnia worse after you stop||
4006|061|H|taking the medication (rebound insomnia).||
4006|062|H|   Though it helps many people, this medication may sometimes||
4006|063|H|cause addiction. This risk may be higher if you have a substance||
4006|064|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
4006|065|H|Do not increase your dose, take it more often, or use it for a||
4006|066|H|longer time than prescribed. Properly stop the medication when so||
4006|067|H|directed.||
4006|068|H|   When used for an extended period, this medication may not work||
4006|069|H|as well and may require different dosing. Talk with your doctor||
4006|070|H|if this medication stops working well.||
4006|071|H|   Tell your doctor if you continue to have trouble sleeping or||
4006|072|H|your child's seizures last or get worse.||
4006|073|B|||
4006|074|S|SIDE EFFECTS:  See also Warning section.||
4006|075|S|   Drowsiness, dizziness, loss of coordination, headache,||
4006|076|S|lightheadedness, nightmares, trouble walking, or falling may||
4006|077|S|occur. To reduce the risk of injury from falling, take this||
4006|078|S|medication right before going to bed. If any of these effects||
4006|079|S|last or get worse, tell your doctor or pharmacist promptly.||
4006|080|S|   This medication may make you sleepy during the day. Tell your||
4006|081|S|doctor if you have daytime drowsiness. Your dose may need to be||
4006|082|S|adjusted. Some people, particularly children, may experience||
4006|083|S|excitability rather than drowsiness.||
4006|084|S|   To reduce the risk of dizziness and lightheadedness, get up||
4006|085|S|slowly when rising from a sitting or lying position.||
4006|086|S|   Remember that this medication has been prescribed because your||
4006|087|S|doctor has judged that the benefit to you is greater than the||
4006|088|S|risk of side effects. Many people using this medication do not||
4006|089|S|have serious side effects.||
4006|090|S|   Tell your doctor right away if you have any serious side||
4006|091|S|effects, including: nausea/vomiting that doesn't stop,||
4006|092|S|mental/mood changes (such as confusion, hallucinations,||
4006|093|S|agitation, anxiety, depression, thoughts of suicide), memory||
4006|094|S|problems, fast/pounding/irregular heartbeat, fainting, muscle||
4006|095|S|spasms, dark urine, stomach/abdominal pain, yellowing eyes/skin,||
4006|096|S|signs of infection (such as sore throat that doesn't go away,||
4006|097|S|fever, chills).||
4006|098|S|   Rarely, after taking this drug, people have gotten out of bed||
4006|099|S|and driven vehicles while not fully awake ("sleep-driving").||
4006|100|S|People have also sleepwalked, prepared/eaten food, made phone||
4006|101|S|calls, or had sex while not fully awake. Often, these people do||
4006|102|S|not remember these events. This problem can be dangerous to you||
4006|103|S|or to others. If you find out that you have done any of these||
4006|104|S|activities after taking this medication, tell your doctor right||
4006|105|S|away. Your risk is increased if you use alcohol or other||
4006|106|S|medications that can make you drowsy while taking nitrazepam.||
4006|107|S|   A very serious allergic reaction to this drug is rare.||
4006|108|S|However, get medical help right away if you notice any symptoms||
4006|109|S|of a serious allergic reaction, including: rash, itching/swelling||
4006|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4006|111|S|breathing.||
4006|112|S|   This is not a complete list of possible side effects. If you||
4006|113|S|notice other effects not listed above, contact your doctor or||
4006|114|S|pharmacist.||
4006|115|S|   In the US -||
4006|116|S|   Call your doctor for medical advice about side effects. You||
4006|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4006|118|S|www.fda.gov/medwatch.||
4006|119|S|   In Canada - Call your doctor for medical advice about side||
4006|120|S|effects. You may report side effects to Health Canada at||
4006|121|S|1-866-234-2345.||
4006|122|B|||
4006|123|P|PRECAUTIONS:  Before taking nitrazepam, tell your doctor or||
4006|124|P|pharmacist if you are allergic to it; or to other benzodiazepines||
4006|125|P|(such as diazepam, temazepam); or if you have any other||
4006|126|P|allergies. This product may contain inactive ingredients, which||
4006|127|P|can cause allergic reactions or other problems. Talk to your||
4006|128|P|pharmacist for more details.||
4006|129|P|   Before using this medication, tell your doctor or pharmacist||
4006|130|P|your medical history, especially of: breathing problems (such as||
4006|131|P|asthma, chronic obstructive pulmonary disease-COPD, sleep apnea),||
4006|132|P|a certain muscle disorder (myasthenia gravis), mental/mood||
4006|133|P|disorders (such as uncontrolled aggression/anger, depression,||
4006|134|P|moderate/severe personality disorder), personal or family history||
4006|135|P|of a substance use disorder (such as overuse of or addiction to||
4006|136|P|drugs/alcohol), kidney disease, liver disease, stroke, an unusual||
4006|137|P|reaction to drugs that cause calmness/drowsiness (such as||
4006|138|P|excitement, agitation, hallucinations).||
4006|139|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4006|140|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4006|141|P|machinery, or do anything that needs alertness until you can do||
4006|142|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
4006|143|P|are using marijuana (cannabis).||
4006|144|P|   Before having surgery, tell your doctor or dentist about all||
4006|145|P|the products you use (including prescription drugs,||
4006|146|P|nonprescription drugs, and herbal products).||
4006|147|P|   Older adults may be more sensitive to the side effects of this||
4006|148|P|drug, especially memory problems and increased risk of falls (due||
4006|149|P|to drowsiness, dizziness, and loss of coordination).||
4006|150|P|   Infants/young children may be at risk for lung infection due||
4006|151|P|to difficulty swallowing, which may lead to saliva getting in the||
4006|152|P|lungs (aspiration).||
4006|153|P|   Tell your doctor if you are pregnant or plan to become||
4006|154|P|pregnant. You should not become pregnant while using nitrazepam.||
4006|155|P|Nitrazepam may harm an unborn baby. Newborn babies of mothers who||
4006|156|P|use this medication late in pregnancy may have symptoms such as||
4006|157|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
4006|158|P|feeding. If you become pregnant, talk to your doctor right away||
4006|159|P|about the risks and benefits of this medication.||
4006|160|P|   It is unknown if this drug passes into breast milk. However,||
4006|161|P|similar drugs pass into breast milk. Consult your doctor before||
4006|162|P|breastfeeding.||
4006|163|B|||
4006|164|I|DRUG INTERACTIONS:  See also Warning section.||
4006|165|I|   Drug interactions may change how your medications work or||
4006|166|I|increase your risk for serious side effects. This document does||
4006|167|I|not contain all possible drug interactions. Keep a list of all||
4006|168|I|the products you use (including prescription/nonprescription||
4006|169|I|drugs and herbal products) and share it with your doctor and||
4006|170|I|pharmacist. Do not start, stop, or change the dosage of any||
4006|171|I|medicines without your doctor's approval.||
4006|172|I|   Some products that may interact with this drug are: orlistat,||
4006|173|I|sodium oxybate.||
4006|174|I|   Other medications can affect the removal of nitrazepam from||
4006|175|I|your body, which may affect how nitrazepam works. Examples||
4006|176|I|include cimetidine, macrolide antibiotics (such as erythromycin),||
4006|177|I|among others.||
4006|178|I|   The risk of serious side effects (such as slow/shallow||
4006|179|I|breathing, severe drowsiness/dizziness) may be increased if this||
4006|180|I|medication is taken with other products that may also cause||
4006|181|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
4006|182|I|if you are taking other products such as opioid pain or cough||
4006|183|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4006|184|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
4006|185|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4006|186|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
4006|187|I|diphenhydramine).||
4006|188|I|   Check the labels on all your medicines (such as allergy or||
4006|189|I|cough-and-cold products) because they may contain ingredients||
4006|190|I|that cause drowsiness. Ask your pharmacist about using those||
4006|191|I|products safely.||
4006|192|B|||
4006|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4006|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4006|195|O|poison control center right away. US residents can call||
4006|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4006|197|O|Symptoms of overdose may include: extreme drowsiness, confusion,||
4006|198|O|decreased muscle reflexes.||
4006|199|B|||
4006|200|N|NOTES:  Do not share this medication with others. Sharing it is||
4006|201|N|against the law.||
4006|202|N|   Consult your doctor or pharmacist for ways to improve your||
4006|203|N|sleep without medication, such as avoiding caffeine and alcohol||
4006|204|N|close to bedtime, avoiding daytime naps, and avoiding going to||
4006|205|N|bed too early each night.||
4006|206|N|   This medication has been prescribed for your current condition||
4006|207|N|only. Do not use it later for another condition unless told to do||
4006|208|N|so by your doctor. A different medication may be necessary in||
4006|209|N|that case.||
4006|210|B|||
4006|211|D|MISSED DOSE:  If you are using this medication to treat seizures||
4006|212|D|and miss a dose, give it as soon as you remember. If it is near||
4006|213|D|the time of the next dose, skip the missed dose. Give your child||
4006|214|D|the next dose at the regular time. Do not double the dose to||
4006|215|D|catch up. If you are using this medication for trouble sleeping||
4006|216|D|and miss a dose, take it as soon as you remember. If you do not||
4006|217|D|have 8 hours to sleep, skip the missed dose. Take your next dose||
4006|218|D|at the regular time.||
4006|219|B|||
4006|220|R|STORAGE:  Store at room temperature away from light and moisture.||
4006|221|R|Do not store in the bathroom. Keep all medications away from||
4006|222|R|children and pets.||
4006|223|R|   Do not flush medications down the toilet or pour them into a||
4006|224|R|drain unless instructed to do so. Properly discard this product||
4006|225|R|when it is expired or no longer needed. Consult your pharmacist||
4006|226|R|or local waste disposal company.||
4006|227|B|||
4006|228|A|Information last revised May 2025.||
4006|229|A|Copyright(c) 2025 First Databank, Inc.||
4006|230|B|||
4007|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4007|002|Z|does NOT have all possible information about this product. This||
4007|003|Z|information does not assure that this product is safe, effective,||
4007|004|Z|or appropriate for you. This information is not individual||
4007|005|Z|medical advice and does not substitute for the advice of your||
4007|006|Z|health care professional. Always ask your health care||
4007|007|Z|professional for complete information about this product and your||
4007|008|Z|specific health needs.||
4007|009|B|||
4007|010|T|CABERGOLINE - ORAL||
4007|011|F|(ka-BER-goe-leen)||
4007|012|B|||
4007|013|C|COMMON BRAND NAME(S): Dostinex||
4007|014|B|||
4007|015|U|USES:  This medication is used to treat high levels of prolactin||
4007|016|U|hormone in your body. High levels of prolactin in women can cause||
4007|017|U|symptoms such as unwanted breast milk and missed periods and can||
4007|018|U|cause difficulty becoming pregnant. High levels of prolactin in||
4007|019|U|men can cause symptoms such as enlarged breasts and decreased||
4007|020|U|sexual ability/desire. Cabergoline is an ergot medication and||
4007|021|U|works by blocking the release of prolactin from the pituitary||
4007|022|U|gland.||
4007|023|B|||
4007|024|H|HOW TO USE:  Take this medication by mouth with or without food||
4007|025|H|as directed by your doctor, usually twice a week.||
4007|026|H|   The dosage is based on your medical condition, labs (prolactin||
4007|027|H|levels), and response to treatment. Your doctor will start you at||
4007|028|H|a low dose and slowly increase your dose over several months to||
4007|029|H|help decrease side effects. Follow your doctor's instructions||
4007|030|H|carefully.||
4007|031|H|   Take this medication regularly to get the most benefit from||
4007|032|H|it. To help you remember, mark your calendar with a reminder.||
4007|033|H|   Tell your doctor if your condition lasts or gets worse.||
4007|034|B|||
4007|035|S|SIDE EFFECTS:  Nausea, vomiting, stomach upset, constipation,||
4007|036|S|dizziness, lightheadedness, or tiredness may occur. If any of||
4007|037|S|these effects last or get worse, tell your doctor or pharmacist||
4007|038|S|promptly.||
4007|039|S|   To reduce the risk of dizziness and lightheadedness, get up||
4007|040|S|slowly when rising from a sitting or lying position.||
4007|041|S|   Remember that this medication has been prescribed because your||
4007|042|S|doctor has judged that the benefit to you is greater than the||
4007|043|S|risk of side effects. Many people using this medication do not||
4007|044|S|have serious side effects.||
4007|045|S|   Tell your doctor right away if you have any serious side||
4007|046|S|effects, including: cough that doesn't go away, mental/mood||
4007|047|S|changes (such as nervousness), unusual strong urges (such as||
4007|048|S|increased gambling, increased sexual urges), vision changes,||
4007|049|S|painful menses, breast pain, symptoms of heart failure (such as||
4007|050|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
4007|051|S|unusual/sudden weight gain).||
4007|052|S|   Get medical help right away if you have any very serious side||
4007|053|S|effects, including: chest pain, signs of kidney problems (such as||
4007|054|S|change in the amount of urine, lower back/flank pain).||
4007|055|S|   A very serious allergic reaction to this drug is rare.||
4007|056|S|However, get medical help right away if you notice any symptoms||
4007|057|S|of a serious allergic reaction, including: rash, itching/swelling||
4007|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4007|059|S|breathing.||
4007|060|S|   This is not a complete list of possible side effects. If you||
4007|061|S|notice other effects not listed above, contact your doctor or||
4007|062|S|pharmacist.||
4007|063|S|   In the US -||
4007|064|S|   Call your doctor for medical advice about side effects. You||
4007|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4007|066|S|www.fda.gov/medwatch.||
4007|067|S|   In Canada - Call your doctor for medical advice about side||
4007|068|S|effects. You may report side effects to Health Canada at||
4007|069|S|1-866-234-2345.||
4007|070|B|||
4007|071|P|PRECAUTIONS:  Before taking cabergoline, tell your doctor or||
4007|072|P|pharmacist if you are allergic to it; or to other ergot||
4007|073|P|medications (such as ergotamine); or if you have any other||
4007|074|P|allergies. This product may contain inactive ingredients, which||
4007|075|P|can cause allergic reactions or other problems. Talk to your||
4007|076|P|pharmacist for more details.||
4007|077|P|   Before using this medication, tell your doctor or pharmacist||
4007|078|P|your medical history, especially of: liver disease, high blood||
4007|079|P|pressure (hypertension), heart valve disease, abnormal||
4007|080|P|scarring/thickening of the lining in the lungs/heart/behind the||
4007|081|P|abdomen (pulmonary/pericardial/retroperitoneal fibrosis).||
4007|082|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4007|083|P|can make you more dizzy. Do not drive, use machinery, or do||
4007|084|P|anything that needs alertness until you can do it safely. Limit||
4007|085|P|alcoholic beverages. Talk to your doctor if you are using||
4007|086|P|marijuana (cannabis).||
4007|087|P|   Before having surgery, tell your doctor or dentist about all||
4007|088|P|the products you use (including prescription drugs,||
4007|089|P|nonprescription drugs, and herbal products).||
4007|090|P|   During pregnancy, this medication should be used only when||
4007|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
4007|092|P|   It is unknown if this medication passes into breast milk.||
4007|093|P|Breastfeeding is not recommended while using this medication.||
4007|094|P|Consult your doctor before breastfeeding.||
4007|095|B|||
4007|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4007|097|I|medications work or increase your risk for serious side effects.||
4007|098|I|This document does not contain all possible drug interactions.||
4007|099|I|Keep a list of all the products you use (including||
4007|100|I|prescription/nonprescription drugs and herbal products) and share||
4007|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
4007|102|I|the dosage of any medicines without your doctor's approval.||
4007|103|I|   Some products that may interact with this drug include:||
4007|104|I|metoclopramide, prochlorperazine.||
4007|105|I|   Other medications can affect the removal of cabergoline from||
4007|106|I|your body, which may affect how cabergoline works. Examples||
4007|107|I|include certain azole antifungals (such as itraconazole,||
4007|108|I|ketoconazole, posaconazole), cobicistat, ritonavir, among others.||
4007|109|B|||
4007|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4007|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4007|112|O|poison control center right away. US residents can call||
4007|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4007|114|O|Symptoms of overdose may include severe dizziness, fainting,||
4007|115|O|mental/mood changes (such as hallucinations).||
4007|116|B|||
4007|117|N|NOTES:  Do not share this medication with others.||
4007|118|N|   Lab and/or medical tests (such as prolactin levels, EKG)||
4007|119|N|should be done before you start taking this medication and while||
4007|120|N|you are taking it. Keep all medical and lab appointments. Consult||
4007|121|N|your doctor for more details.||
4007|122|B|||
4007|123|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4007|124|D|remember. If it is near the time of the next dose, skip the||
4007|125|D|missed dose. Take your next dose at the regular time. Do not||
4007|126|D|double the dose to catch up.||
4007|127|B|||
4007|128|R|STORAGE:  Store at room temperature away from light and moisture.||
4007|129|R|Do not store in the bathroom. Keep all medications away from||
4007|130|R|children and pets.||
4007|131|R|   Do not flush medications down the toilet or pour them into a||
4007|132|R|drain unless instructed to do so. Properly discard this product||
4007|133|R|when it is expired or no longer needed. Consult your pharmacist||
4007|134|R|or local waste disposal company.||
4007|135|B|||
4007|136|A|Information last revised March 2025.||
4007|137|A|Copyright(c) 2025 First Databank, Inc.||
4007|138|B|||
4008|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4008|002|Z|does NOT have all possible information about this product. This||
4008|003|Z|information does not assure that this product is safe, effective,||
4008|004|Z|or appropriate for you. This information is not individual||
4008|005|Z|medical advice and does not substitute for the advice of your||
4008|006|Z|health care professional. Always ask your health care||
4008|007|Z|professional for complete information about this product and your||
4008|008|Z|specific health needs.||
4008|009|B|||
4008|010|T|EPINEPHRINE - INJECTION||
4008|011|F|(EP-i-NEF-rin)||
4008|012|B|||
4008|013|C|COMMON BRAND NAME(S): Auvi-Q, Epipen, Symjepi, Twinject||
4008|014|B|||
4008|015|U|USES:  This medication is used in emergencies to treat very||
4008|016|U|serious allergic reactions to insect stings/bites, foods, drugs,||
4008|017|U|or other substances. Epinephrine works quickly to improve||
4008|018|U|breathing, stimulate the heart, raise a dropping blood pressure,||
4008|019|U|reverse hives, and reduce swelling of the face, lips, and throat.||
4008|020|B|||
4008|021|H|HOW TO USE:  Read the Patient Information Leaflet and||
4008|022|H|Instructions for Use provided by your pharmacist before you need||
4008|023|H|to use epinephrine and each time you get a refill. If you have||
4008|024|H|any questions, ask your doctor or pharmacist.||
4008|025|H|   Keep this product near you at all times. When you receive it||
4008|026|H|and before you need to use it, check that the product comes out||
4008|027|H|of its carrying case easily. If it does not, consult your||
4008|028|H|pharmacist.||
4008|029|H|   The solution in this product should be clear. From time to||
4008|030|H|time, check this product visually for particles or discoloration.||
4008|031|H|If it has turned cloudy or pink/brown in color, do not use the||
4008|032|H|product. Discard and replace it.||
4008|033|H|   Different brands of this medication have different directions||
4008|034|H|for preparing and using this medication. Learn ahead of time how||
4008|035|H|to properly inject this medication so you will be ready if you||
4008|036|H|need to use it. Also, make sure a family member, caregiver, or||
4008|037|H|other responsible person knows where you keep this medication and||
4008|038|H|how to use it in case you cannot inject the medication yourself.||
4008|039|H|The dosage is based on your medical condition, weight, and||
4008|040|H|response to treatment.||
4008|041|H|   Inject this medication into the thigh as directed by your||
4008|042|H|doctor and the manufacturer. This medication can be injected||
4008|043|H|through clothing if needed. This medication acts quickly but does||
4008|044|H|not last long. After injecting epinephrine, get medical help||
4008|045|H|right away. Tell the health care professional that you have given||
4008|046|H|yourself an injection of epinephrine. You may need another dose||
4008|047|H|of epinephrine if your symptoms do not get better, or if they||
4008|048|H|return after one dose.||
4008|049|H|   Avoid injecting this medication into the hands, feet,||
4008|050|H|buttocks, or areas of your body other than the thigh. If this||
4008|051|H|accidentally happens, get medical help right away. For infants||
4008|052|H|and young children, be sure to hold their leg firmly in place||
4008|053|H|before and during the injection to prevent injury. Discard the||
4008|054|H|injector properly after use.||
4008|055|B|||
4008|056|S|SIDE EFFECTS:  Fast/pounding heartbeat, nervousness, sweating,||
4008|057|S|nausea, vomiting, trouble breathing, headache, dizziness,||
4008|058|S|anxiety, shakiness, or pale skin may occur. If any of these||
4008|059|S|effects last or get worse, tell your doctor or pharmacist||
4008|060|S|promptly.||
4008|061|S|   Remember that this medication has been prescribed because your||
4008|062|S|doctor has judged that the benefit to you is greater than the||
4008|063|S|risk of side effects. Many people using this medication do not||
4008|064|S|have serious side effects.||
4008|065|S|   Tell your doctor right away if you have any serious side||
4008|066|S|effects, including: irregular heartbeat, signs of infection at||
4008|067|S|the injection site (such as redness that doesn't go away, warmth,||
4008|068|S|swelling, or pain).||
4008|069|S|   Get medical help right away if you have any very serious side||
4008|070|S|effects, including: chest pain, fainting, vision changes,||
4008|071|S|seizures, confusion.||
4008|072|S|   This is not a complete list of possible side effects. If you||
4008|073|S|notice other effects not listed above, contact your doctor or||
4008|074|S|pharmacist.||
4008|075|S|   In the US -||
4008|076|S|   Call your doctor for medical advice about side effects. You||
4008|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4008|078|S|www.fda.gov/medwatch.||
4008|079|S|   In Canada - Call your doctor for medical advice about side||
4008|080|S|effects. You may report side effects to Health Canada at||
4008|081|S|1-866-234-2345.||
4008|082|B|||
4008|083|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
4008|084|P|pharmacist if you are allergic to it; or if you have any other||
4008|085|P|allergies. This product may contain inactive ingredients, which||
4008|086|P|can cause allergic reactions or other problems. Talk to your||
4008|087|P|pharmacist for more details.||
4008|088|P|   This product may contain sulfites. However, if you have a||
4008|089|P|sulfite allergy, you should still use this medication during an||
4008|090|P|emergency. Since epinephrine can save your life, using it is more||
4008|091|P|important than avoiding any sulfite-related problems.||
4008|092|P|   Before using this medication, tell your doctor or pharmacist||
4008|093|P|your medical history, especially of: heart problems (such as||
4008|094|P|angina, irregular heartbeat), high blood pressure, thyroid||
4008|095|P|disease, diabetes.||
4008|096|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4008|097|P|can make you more dizzy. Do not drive, use machinery, or do||
4008|098|P|anything that needs alertness until you can do it safely. Limit||
4008|099|P|alcoholic beverages. Talk to your doctor if you are using||
4008|100|P|marijuana (cannabis).||
4008|101|P|   Older adults may be more sensitive to the side effects of this||
4008|102|P|drug, especially a rapid rise in blood pressure.||
4008|103|P|   If you are pregnant, this drug can be used the same way as if||
4008|104|P|you were not pregnant.||
4008|105|P|   It is unknown if this medication passes into breast milk, but||
4008|106|P|it is unlikely to harm a nursing infant. Consult your doctor||
4008|107|P|before breastfeeding.||
4008|108|B|||
4008|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4008|110|I|medications work or increase your risk for serious side effects.||
4008|111|I|This document does not contain all possible drug interactions.||
4008|112|I|Keep a list of all the products you use (including||
4008|113|I|prescription/nonprescription drugs and herbal products) and share||
4008|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
4008|115|I|the dosage of any medicines without your doctor's approval.||
4008|116|B|||
4008|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4008|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4008|119|O|poison control center right away. US residents can call||
4008|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4008|121|O|Symptoms of overdose may include: irregular heartbeat, fainting,||
4008|122|O|vision changes, confusion, seizures.||
4008|123|B|||
4008|124|N|NOTES:  Do not share this medication with others.||
4008|125|B|||
4008|126|D|MISSED DOSE:  Not applicable.||
4008|127|B|||
4008|128|R|STORAGE:  Store at room temperature. Do not refrigerate or||
4008|129|R|freeze. Keep the product in the carrying case/original packaging||
4008|130|R|to protect from light. Avoid extreme heat and cold (such as||
4008|131|R|storing in your vehicle). From time to time, check the expiration||
4008|132|R|date and replace the unit before it expires. Keep all medications||
4008|133|R|away from children and pets.||
4008|134|R|   Do not flush medications down the toilet or pour them into a||
4008|135|R|drain unless instructed to do so. Properly discard this||
4008|136|R|medication when it is expired or no longer needed. Consult your||
4008|137|R|pharmacist or local waste disposal company.||
4008|138|B|||
4008|139|A|Information last revised July 2024.||
4008|140|A|Copyright(c) 2025 First Databank, Inc.||
4008|141|B|||
4010|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4010|002|Z|does NOT have all possible information about this product. This||
4010|003|Z|information does not assure that this product is safe, effective,||
4010|004|Z|or appropriate for you. This information is not individual||
4010|005|Z|medical advice and does not substitute for the advice of your||
4010|006|Z|health care professional. Always ask your health care||
4010|007|Z|professional for complete information about this product and your||
4010|008|Z|specific health needs.||
4010|009|B|||
4010|010|T|FELODIPINE EXTENDED-RELEASE - ORAL||
4010|011|F|(fell-OH-dih-peen)||
4010|012|B|||
4010|013|C|COMMON BRAND NAME(S): Plendil||
4010|014|B|||
4010|015|U|USES:  Felodipine is used to treat high blood pressure||
4010|016|U|(hypertension). Lowering high blood pressure helps prevent||
4010|017|U|strokes, heart attacks, and kidney problems. Felodipine is known||
4010|018|U|as a calcium channel blocker. By blocking calcium, this||
4010|019|U|medication relaxes and widens blood vessels so blood can flow||
4010|020|U|more easily.||
4010|021|B|||
4010|022|V|OTHER USES:  This section contains uses of this drug that are not||
4010|023|V|listed in the approved professional labeling for the drug but||
4010|024|V|that may be prescribed by your health care professional. Use this||
4010|025|V|drug for a condition that is listed in this section only if it||
4010|026|V|has been so prescribed by your health care professional.||
4010|027|V|   This drug may also be used to reduce the risk of chest pain||
4010|028|V|(angina).||
4010|029|B|||
4010|030|H|HOW TO USE:  Take this medication by mouth on an empty stomach as||
4010|031|H|directed by your doctor, usually once a day. If stomach upset||
4010|032|H|occurs, felodipine may be taken with a light meal. The dosage is||
4010|033|H|based on your medical condition and response to treatment.||
4010|034|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
4010|035|H|Doing so can release all of the drug at once, increasing the risk||
4010|036|H|of side effects.||
4010|037|H|   Use this medication regularly in order to get the most benefit||
4010|038|H|from it. Remember to use it at the same time each day as||
4010|039|H|directed. Keep taking this medication even if you feel well. Most||
4010|040|H|people with high blood pressure do not feel sick.||
4010|041|H|   This drug is not effective if you use it only when chest pain||
4010|042|H|occurs. It is very important to take this medication regularly as||
4010|043|H|prescribed to help prevent chest pain.||
4010|044|H|   Avoid eating grapefruit or drinking grapefruit juice while||
4010|045|H|using this medication unless your doctor or pharmacist says you||
4010|046|H|may do so safely. Grapefruit can increase the chance of side||
4010|047|H|effects with this medicine. Ask your doctor or pharmacist for||
4010|048|H|more details.||
4010|049|H|   Do not stop taking this medication without consulting your||
4010|050|H|doctor. Some conditions may become worse when the drug is||
4010|051|H|suddenly stopped. Your dose may need to be gradually decreased.||
4010|052|B|||
4010|053|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, flushing, or||
4010|054|S|stomach upset may occur as your body adjusts to the medication.||
4010|055|S|If any of these effects last or get worse, tell your doctor or||
4010|056|S|pharmacist promptly.||
4010|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
4010|058|S|slowly when rising from a sitting or lying position.||
4010|059|S|   Remember that this medication has been prescribed because your||
4010|060|S|doctor has judged that the benefit to you is greater than the||
4010|061|S|risk of side effects. Many people using this medication do not||
4010|062|S|have serious side effects.||
4010|063|S|   Although unlikely, felodipine may cause mild swelling of the||
4010|064|S|gums. Massage your gums and brush and floss your teeth regularly||
4010|065|S|to minimize this problem. See your dentist regularly.||
4010|066|S|   Tell your doctor right away if you have any serious side||
4010|067|S|effects, including: swelling of the hands/ankles/feet (edema),||
4010|068|S|fast/irregular heartbeat, fainting.||
4010|069|S|   Although this medication is effective in preventing chest pain||
4010|070|S|(angina), some people who already have severe heart disease may||
4010|071|S|rarely develop worsening chest pain or a heart attack after||
4010|072|S|starting this medication or increasing the dose. Get medical help||
4010|073|S|right away if you experience: worsening chest pain, symptoms of a||
4010|074|S|heart attack (such as chest/jaw/left arm pain, shortness of||
4010|075|S|breath, unusual sweating).||
4010|076|S|   A very serious allergic reaction to this drug is rare.||
4010|077|S|However, get medical help right away if you notice any symptoms||
4010|078|S|of a serious allergic reaction, including: rash, itching/swelling||
4010|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4010|080|S|breathing.||
4010|081|S|   This is not a complete list of possible side effects. If you||
4010|082|S|notice other effects not listed above, contact your doctor or||
4010|083|S|pharmacist.||
4010|084|S|   In the US -||
4010|085|S|   Call your doctor for medical advice about side effects. You||
4010|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4010|087|S|www.fda.gov/medwatch.||
4010|088|S|   In Canada - Call your doctor for medical advice about side||
4010|089|S|effects. You may report side effects to Health Canada at||
4010|090|S|1-866-234-2345.||
4010|091|B|||
4010|092|P|PRECAUTIONS:  Before taking felodipine, tell your doctor or||
4010|093|P|pharmacist if you are allergic to it; or if you have any other||
4010|094|P|allergies. This product may contain inactive ingredients, which||
4010|095|P|can cause allergic reactions or other problems. Talk to your||
4010|096|P|pharmacist for more details.||
4010|097|P|   Before using this medication, tell your doctor or pharmacist||
4010|098|P|your medical history, especially of: heart disease (such as heart||
4010|099|P|failure), liver disease, swelling of the arms and legs (edema).||
4010|100|P|   Before having surgery, tell your doctor or dentist about all||
4010|101|P|the products you use (including prescription drugs,||
4010|102|P|nonprescription drugs, and herbal products).||
4010|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4010|104|P|can make you more dizzy. Do not drive, use machinery, or do||
4010|105|P|anything that needs alertness until you can do it safely. Limit||
4010|106|P|alcoholic beverages. Talk to your doctor if you are using||
4010|107|P|marijuana (cannabis).||
4010|108|P|   Older adults may be more sensitive to the side effects of this||
4010|109|P|drug, especially dizziness.||
4010|110|P|   During pregnancy, this medication should be used only when||
4010|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
4010|112|P|   It is unknown if this drug passes into breast milk. Consult||
4010|113|P|your doctor before breastfeeding.||
4010|114|B|||
4010|115|I|DRUG INTERACTIONS:  See also How to Use section.||
4010|116|I|   Drug interactions may change how your medications work or||
4010|117|I|increase your risk for serious side effects. This document does||
4010|118|I|not contain all possible drug interactions. Keep a list of all||
4010|119|I|the products you use (including prescription/nonprescription||
4010|120|I|drugs and herbal products) and share it with your doctor and||
4010|121|I|pharmacist. Do not start, stop, or change the dosage of any||
4010|122|I|medicines without your doctor's approval.||
4010|123|I|   Other medications can affect the removal of felodipine from||
4010|124|I|your body, which may affect how felodipine works. Examples||
4010|125|I|include azole antifungals (such as itraconazole, ketoconazole),||
4010|126|I|macrolide antibiotics (such as erythromycin), among others.||
4010|127|I|   Some products have ingredients that could raise your blood||
4010|128|I|pressure. Tell your pharmacist what products you are using, and||
4010|129|I|ask how to use them safely (especially cough-and-cold products,||
4010|130|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
4010|131|B|||
4010|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4010|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4010|134|O|poison control center right away. US residents can call||
4010|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4010|136|O|Symptoms of overdose may include: severe dizziness, slow||
4010|137|O|heartbeat, severe weakness.||
4010|138|B|||
4010|139|N|NOTES:  Do not share this medication with others.||
4010|140|N|   Lifestyle changes such as stress reduction programs, exercise,||
4010|141|N|and dietary changes may increase the effectiveness of this||
4010|142|N|medicine. Talk to your doctor or pharmacist about lifestyle||
4010|143|N|changes that might benefit you.||
4010|144|N|   Have your blood pressure checked regularly while taking this||
4010|145|N|medication. It may be best to learn how to monitor your own blood||
4010|146|N|pressure. Discuss with your doctor and inform him/her of your||
4010|147|N|blood pressure readings.||
4010|148|B|||
4010|149|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4010|150|D|If it is near the time of the next dose, skip the missed dose.||
4010|151|D|Use your next dose at the regular time. Do not double the dose to||
4010|152|D|catch up.||
4010|153|B|||
4010|154|R|STORAGE:  Store at room temperature away from light and moisture.||
4010|155|R|Do not store in the bathroom. Keep all medications away from||
4010|156|R|children and pets.||
4010|157|R|   Do not flush medications down the toilet or pour them into a||
4010|158|R|drain unless instructed to do so. Properly discard this product||
4010|159|R|when it is expired or no longer needed. Consult your pharmacist||
4010|160|R|or local waste disposal company.||
4010|161|B|||
4010|162|M|MEDICAL ALERT:  Your condition can cause complications in a||
4010|163|M|medical emergency. For information about enrolling in MedicAlert,||
4010|164|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4010|165|B|||
4010|166|A|Information last revised May 2024.||
4010|167|A|Copyright(c) 2025 First Databank, Inc.||
4010|168|B|||
4011|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4011|002|Z|does NOT have all possible information about this product. This||
4011|003|Z|information does not assure that this product is safe, effective,||
4011|004|Z|or appropriate for you. This information is not individual||
4011|005|Z|medical advice and does not substitute for the advice of your||
4011|006|Z|health care professional. Always ask your health care||
4011|007|Z|professional for complete information about this product and your||
4011|008|Z|specific health needs.||
4011|009|B|||
4011|010|T|CEFPROZIL - ORAL||
4011|011|F|(seff-PRO-zill)||
4011|012|B|||
4011|013|C|COMMON BRAND NAME(S): Cefzil||
4011|014|B|||
4011|015|U|USES:  Cefprozil is used to treat a wide variety of bacterial||
4011|016|U|infections. This medication is known as a cephalosporin||
4011|017|U|antibiotic. It works by stopping the growth of bacteria.||
4011|018|U|   This antibiotic treats only bacterial infections. It will not||
4011|019|U|work for viral infections (such as common cold, flu). Using any||
4011|020|U|antibiotic when it is not needed can cause it to not work for||
4011|021|U|future infections.||
4011|022|B|||
4011|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
4011|024|H|doctor, usually once or twice daily. You may take this medicine||
4011|025|H|with food if stomach upset occurs. The dosage is based on your||
4011|026|H|medical condition and response to treatment. Children's dosage is||
4011|027|H|also based on weight.||
4011|028|H|   For the best effect, take this antibiotic at evenly spaced||
4011|029|H|times. To help you remember, take this medication at the same||
4011|030|H|time(s) every day.||
4011|031|H|   Continue to take this medication until the full prescribed||
4011|032|H|amount is finished, even if symptoms disappear after a few days.||
4011|033|H|Stopping the medication too early may result in a return of the||
4011|034|H|infection.||
4011|035|H|   Tell your doctor if your condition lasts or gets worse.||
4011|036|B|||
4011|037|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach pain, or||
4011|038|S|dizziness may occur. If any of these effects last or get worse,||
4011|039|S|tell your doctor or pharmacist promptly.||
4011|040|S|   Remember that this medication has been prescribed because your||
4011|041|S|doctor has judged that the benefit to you is greater than the||
4011|042|S|risk of side effects. Many people using this medication do not||
4011|043|S|have serious side effects.||
4011|044|S|   Tell your doctor right away if you have any serious side||
4011|045|S|effects, including: nausea/vomiting that doesn't stop, unusual||
4011|046|S|tiredness/weakness, yellowing of the eyes/skin, severe||
4011|047|S|stomach/abdominal pain, dark urine, signs of kidney problems||
4011|048|S|(such as change in the amount of urine), signs of new infection||
4011|049|S|(such as sore throat that doesn't go away, fever), easy||
4011|050|S|bruising/bleeding, mental/mood changes (such as confusion).||
4011|051|S|   This medication may rarely cause a severe intestinal condition||
4011|052|S|due to a bacteria called C. difficile. This condition may occur||
4011|053|S|during treatment or weeks to months after treatment has stopped.||
4011|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
4011|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
4011|056|S|stool.||
4011|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4011|058|S|products because they may make symptoms worse.||
4011|059|S|   Use of this medication for prolonged or repeated periods may||
4011|060|S|result in oral thrush or a new vaginal yeast infection (oral or||
4011|061|S|vaginal fungal infection). Contact your doctor if you notice||
4011|062|S|white patches in your mouth, a change in vaginal discharge or||
4011|063|S|other new symptoms.||
4011|064|S|   A very serious allergic reaction to this drug is rare.||
4011|065|S|However, get medical help right away if you notice any symptoms||
4011|066|S|of a serious allergic reaction, including: rash, itching/swelling||
4011|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4011|068|S|breathing.||
4011|069|S|   This is not a complete list of possible side effects. If you||
4011|070|S|notice other effects not listed above, contact your doctor or||
4011|071|S|pharmacist.||
4011|072|S|   In the US -||
4011|073|S|   Call your doctor for medical advice about side effects. You||
4011|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4011|075|S|www.fda.gov/medwatch.||
4011|076|S|   In Canada - Call your doctor for medical advice about side||
4011|077|S|effects. You may report side effects to Health Canada at||
4011|078|S|1-866-234-2345.||
4011|079|B|||
4011|080|P|PRECAUTIONS:  Before taking cefprozil, tell your doctor or||
4011|081|P|pharmacist if you are allergic to it; or to penicillins or other||
4011|082|P|cephalosporin antibiotics (such as cephalexin); or if you have||
4011|083|P|any other allergies. This product may contain inactive||
4011|084|P|ingredients, which can cause allergic reactions or other||
4011|085|P|problems. Talk to your pharmacist for more details.||
4011|086|P|   Before using this medication, tell your doctor or pharmacist||
4011|087|P|your medical history, especially of: kidney disease, intestinal||
4011|088|P|disease (colitis).||
4011|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4011|090|P|can make you more dizzy. Do not drive, use machinery, or do||
4011|091|P|anything that needs alertness until you can do it safely. Limit||
4011|092|P|alcoholic beverages. Talk to your doctor if you are using||
4011|093|P|marijuana (cannabis).||
4011|094|P|   Cefprozil may cause live bacterial vaccines (such as typhoid||
4011|095|P|vaccine) to not work well. Tell your health care professional||
4011|096|P|that you are using cefprozil before having any||
4011|097|P|immunizations/vaccinations.||
4011|098|P|   Before having surgery, tell your doctor or dentist about all||
4011|099|P|the products you use (including prescription drugs,||
4011|100|P|nonprescription drugs, and herbal products).||
4011|101|P|   Older adults may be more sensitive to the side effects of this||
4011|102|P|drug.||
4011|103|P|   Children may be more sensitive to the side effects of this||
4011|104|P|drug, especially rash.||
4011|105|P|   During pregnancy, this medication should be used only when||
4011|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
4011|107|P|   This medication passes into breast milk. Consult your doctor||
4011|108|P|before breastfeeding.||
4011|109|B|||
4011|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4011|111|I|medications work or increase your risk for serious side effects.||
4011|112|I|This document does not contain all possible drug interactions.||
4011|113|I|Keep a list of all the products you use (including||
4011|114|I|prescription/nonprescription drugs and herbal products) and share||
4011|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
4011|116|I|the dosage of any medicines without your doctor's approval.||
4011|117|I|   This medication may interfere with certain lab tests (such as||
4011|118|I|certain diabetic urine tests, blood glucose tests), possibly||
4011|119|I|causing false test results. Make sure lab personnel and all your||
4011|120|I|doctors know you use this drug.||
4011|121|B|||
4011|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4011|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4011|124|O|poison control center right away. US residents can call||
4011|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4011|126|O|Symptoms of overdose may include seizures.||
4011|127|B|||
4011|128|N|NOTES:  Do not share this medication with others.||
4011|129|N|   This medication has been prescribed for your current condition||
4011|130|N|only. Do not use it later for another infection unless your||
4011|131|N|doctor tells you to.||
4011|132|B|||
4011|133|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4011|134|D|remember. If it is near the time of the next dose, skip the||
4011|135|D|missed dose. Take your next dose at the regular time. Do not||
4011|136|D|double the dose to catch up.||
4011|137|B|||
4011|138|R|STORAGE:  Store at room temperature away from light and moisture.||
4011|139|R|Do not store in the bathroom. Keep all medications away from||
4011|140|R|children and pets.||
4011|141|R|   Do not flush medications down the toilet or pour them into a||
4011|142|R|drain unless instructed to do so. Properly discard this product||
4011|143|R|when it is expired or no longer needed. Consult your pharmacist||
4011|144|R|or local waste disposal company.||
4011|145|B|||
4011|146|A|Information last revised August 2024.||
4011|147|A|Copyright(c) 2025 First Databank, Inc.||
4011|148|B|||
4012|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4012|002|Z|does NOT have all possible information about this product. This||
4012|003|Z|information does not assure that this product is safe, effective,||
4012|004|Z|or appropriate for you. This information is not individual||
4012|005|Z|medical advice and does not substitute for the advice of your||
4012|006|Z|health care professional. Always ask your health care||
4012|007|Z|professional for complete information about this product and your||
4012|008|Z|specific health needs.||
4012|009|B|||
4012|010|T|DIPHENHYDRAMINE - INJECTION||
4012|011|F|(dye-fen-HI-druh-meen)||
4012|012|B|||
4012|013|C|COMMON BRAND NAME(S): Benadryl||
4012|014|B|||
4012|015|U|USES:  Diphenhydramine injection is an antihistamine used to||
4012|016|U|treat life-threatening allergic reactions (anaphylaxis) along||
4012|017|U|with epinephrine and other treatments. It is also used to relieve||
4012|018|U|symptoms of household allergies, hay fever and the common cold||
4012|019|U|when medication cannot be given by mouth. Common allergy symptoms||
4012|020|U|relieved by antihistamines include rash, itching, watery eyes,||
4012|021|U|itchy eyes/nose/throat, cough, runny nose and sneezing.||
4012|022|U|   It is also used to treat nausea, vomiting and dizziness caused||
4012|023|U|by motion sickness when medication cannot be given by mouth.||
4012|024|U|Diphenhydramine works by blocking a certain natural substance||
4012|025|U|(histamine) that your body makes during an allergic reaction. Its||
4012|026|U|drying effects on such symptoms as watery eyes and runny nose are||
4012|027|U|caused by blocking another natural substance made by your body||
4012|028|U|(acetylcholine).||
4012|029|U|   Diphenhydramine should not be used in newborns or premature||
4012|030|U|infants because of an increased risk of side effects. It should||
4012|031|U|not be used for common cold symptoms in children less than 6||
4012|032|U|years of age due to the risk of serious side effects, such as||
4012|033|U|slow/shallow breathing. Cough-and-cold products have not been||
4012|034|U|shown to be safe or effective in children younger than 6.||
4012|035|B|||
4012|036|V|OTHER USES:  This section contains uses of this drug that are not||
4012|037|V|listed in the approved professional labeling for the drug but||
4012|038|V|that may be prescribed by your health care professional. Use this||
4012|039|V|drug for a condition that is listed in this section only if it||
4012|040|V|has been so prescribed by your health care professional.||
4012|041|V|   This drug may also be used for shaking (tremor) and muscle||
4012|042|V|stiffness caused by Parkinson's disease when medication cannot be||
4012|043|V|given by mouth. It may also be used for side effects of certain||
4012|044|V|psychiatric drugs such as involuntary movements and muscle||
4012|045|V|stiffness (such as EPS).||
4012|046|B|||
4012|047|H|HOW TO USE:  This medication is given by injection into a vein or||
4012|048|H|into a muscle as directed by your doctor. The dosage is based on||
4012|049|H|your medical condition and response to treatment. Do not use this||
4012|050|H|medication more often than prescribed.||
4012|051|H|   Do not inject this medication into the skin or just under the||
4012|052|H|skin because it can destroy the skin and tissues around the||
4012|053|H|injection site (necrosis).||
4012|054|H|   If you are giving this medication to yourself at home, learn||
4012|055|H|all preparation and usage instructions from your health care||
4012|056|H|professional. Before using, check this product for particles or||
4012|057|H|discoloration. If either is present, do not use the liquid. Learn||
4012|058|H|how to store and discard medical supplies safely.||
4012|059|H|   Tell your doctor if your condition does not get better or if||
4012|060|H|it gets worse.||
4012|061|B|||
4012|062|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, irritability,||
4012|063|S|stomach upset, blurred vision, decreased coordination,||
4012|064|S|constipation, or dry mouth/nose/throat may occur. These effects||
4012|065|S|may decrease as your body adjusts to the medication. If any of||
4012|066|S|these effects last or get worse, tell your doctor or pharmacist||
4012|067|S|promptly.||
4012|068|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
4012|069|S|chips, chew (sugarless) gum, drink water or use a saliva||
4012|070|S|substitute.||
4012|071|S|   To reduce the risk of dizziness and lightheadedness, get up||
4012|072|S|slowly when rising from a sitting or lying position.||
4012|073|S|   Remember that this medication has been prescribed because your||
4012|074|S|doctor has judged that the benefit to you is greater than the||
4012|075|S|risk of side effects. Many people using this medication do not||
4012|076|S|have serious side effects.||
4012|077|S|   Tell your doctor right away if you have any serious side||
4012|078|S|effects, including: mental/mood changes (such as restlessness,||
4012|079|S|confusion), pounding/irregular heartbeat, ringing in the ears,||
4012|080|S|seizure, difficulty urinating.||
4012|081|S|   A very serious allergic reaction to this drug is rare.||
4012|082|S|However, get medical help right away if you notice any symptoms||
4012|083|S|of a serious allergic reaction, including: rash, itching/swelling||
4012|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4012|085|S|breathing.||
4012|086|S|   This is not a complete list of possible side effects. If you||
4012|087|S|notice other effects not listed above, contact your doctor or||
4012|088|S|pharmacist.||
4012|089|S|   In the US -||
4012|090|S|   Call your doctor for medical advice about side effects. You||
4012|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4012|092|S|www.fda.gov/medwatch.||
4012|093|S|   In Canada - Call your doctor for medical advice about side||
4012|094|S|effects. You may report side effects to Health Canada at||
4012|095|S|1-866-234-2345.||
4012|096|B|||
4012|097|P|PRECAUTIONS:  Before using diphenhydramine, tell your doctor or||
4012|098|P|pharmacist if you are allergic to it; or to dimenhydrinate; or if||
4012|099|P|you have any other allergies. This product may contain inactive||
4012|100|P|ingredients, which can cause allergic reactions or other||
4012|101|P|problems. Talk to your pharmacist for more details.||
4012|102|P|   Before using this medication, tell your doctor or pharmacist||
4012|103|P|your medical history, especially of: breathing problems (such as||
4012|104|P|asthma, emphysema), glaucoma, heart problems, high blood||
4012|105|P|pressure, liver disease, mental/mood disorders, seizures, stomach||
4012|106|P|problems (such as ulcers, obstruction), overactive thyroid,||
4012|107|P|difficulty urinating (such as due to enlarged prostate, urinary||
4012|108|P|retention).||
4012|109|P|   This drug may make you dizzy or drowsy or blur your vision.||
4012|110|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
4012|111|P|drowsy. Do not drive, use machinery, or do anything that needs||
4012|112|P|alertness or clear vision until you can do it safely. Limit||
4012|113|P|alcoholic beverages. Talk to your doctor if you are using||
4012|114|P|marijuana (cannabis).||
4012|115|P|   Before having surgery, tell your doctor or dentist about all||
4012|116|P|the products you use (including prescription drugs,||
4012|117|P|nonprescription drugs, and herbal products).||
4012|118|P|   Children may be more sensitive to the side effects of this||
4012|119|P|drug. This drug can often cause excitement in young children||
4012|120|P|instead of drowsiness.||
4012|121|P|   Older adults may be more sensitive to the side effects of this||
4012|122|P|drug, especially drowsiness, dizziness, low blood pressure,||
4012|123|P|confusion, constipation, or trouble urinating. Drowsiness,||
4012|124|P|dizziness, and confusion can increase the risk of falling.||
4012|125|P|   During pregnancy, this medication should be used only when||
4012|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
4012|127|P|   This drug passes into breast milk and may have undesirable||
4012|128|P|effects on a nursing infant. Consult your doctor before||
4012|129|P|breastfeeding.||
4012|130|B|||
4012|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4012|132|I|medications work or increase your risk for serious side effects.||
4012|133|I|This document does not contain all possible drug interactions.||
4012|134|I|Keep a list of all the products you use (including||
4012|135|I|prescription/nonprescription drugs and herbal products) and share||
4012|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
4012|137|I|the dosage of any medicines without your doctor's approval.||
4012|138|I|   Some products that may interact with this drug include:||
4012|139|I|antihistamines applied to the skin (such as diphenhydramine||
4012|140|I|cream, ointment, spray).||
4012|141|I|   Tell your doctor or pharmacist if you are taking other||
4012|142|I|products that cause drowsiness such as opioid pain or cough||
4012|143|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4012|144|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4012|145|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4012|146|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
4012|147|I|chlorpheniramine).||
4012|148|I|   Check the labels on all your medicines (such as allergy or||
4012|149|I|cough-and-cold products) because they may contain ingredients||
4012|150|I|that cause drowsiness. Ask your pharmacist about using those||
4012|151|I|products safely.||
4012|152|I|   This medication may interfere with certain lab tests (such as||
4012|153|I|allergy skin test), possibly causing false test results. Make||
4012|154|I|sure lab personnel and all your doctors know you use this drug.||
4012|155|B|||
4012|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4012|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4012|158|O|poison control center right away. US residents can call||
4012|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4012|160|O|Symptoms of overdose may include: severe drowsiness, seizures,||
4012|161|O|widened pupils. In children, mental/mood changes (such as||
4012|162|O|restlessness, irritability, hallucinations) may occur before||
4012|163|O|drowsiness.||
4012|164|B|||
4012|165|N|NOTES:  Do not share this medication with others.||
4012|166|B|||
4012|167|D|MISSED DOSE:  If you miss a dose, use it as soon you remember. If||
4012|168|D|it is near the time of your next dose, skip the missed dose. Use||
4012|169|D|your next dose at the regular time. Do not double the dose to||
4012|170|D|catch up.||
4012|171|B|||
4012|172|R|STORAGE:  Store at room temperature away from light. Keep all||
4012|173|R|medications away from children and pets.||
4012|174|R|   Do not flush medications down the toilet or pour them into a||
4012|175|R|drain unless instructed to do so. Properly discard this product||
4012|176|R|when it is expired or no longer needed. Consult your pharmacist||
4012|177|R|or local waste disposal company.||
4012|178|B|||
4012|179|A|Information last revised October 2024.||
4012|180|A|Copyright(c) 2025 First Databank, Inc.||
4012|181|B|||
4016|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4016|002|Z|does NOT have all possible information about this product. This||
4016|003|Z|information does not assure that this product is safe, effective,||
4016|004|Z|or appropriate for you. This information is not individual||
4016|005|Z|medical advice and does not substitute for the advice of your||
4016|006|Z|health care professional. Always ask your health care||
4016|007|Z|professional for complete information about this product and your||
4016|008|Z|specific health needs.||
4016|009|B|||
4016|010|T|CLINDAMYCIN/BENZOYL PEROXIDE - TOPICAL||
4016|011|F|(KLIN-da-MYE-sin/BEN-zoh-ill per-OX-ide)||
4016|012|B|||
4016|013|C|COMMON BRAND NAME(S): Benzaclin, Duac, Onexton||
4016|014|B|||
4016|015|U|USES:  This combination medication is used to treat a certain||
4016|016|U|type of acne (inflammatory acne vulgaris). It helps to decrease||
4016|017|U|the number of acne pimples. Clindamycin is an antibiotic that||
4016|018|U|stops the growth of acne-causing bacteria. Benzoyl peroxide can||
4016|019|U|also stop the growth of bacteria as well as reduce oil production||
4016|020|U|in the skin, helping keep your pores open.||
4016|021|B|||
4016|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4016|023|H|from your pharmacist before you start using clindamycin/benzoyl||
4016|024|H|peroxide and each time you get a refill. If you have any||
4016|025|H|questions, ask your doctor or pharmacist.||
4016|026|H|   Before using this medication, wash the affected skin gently||
4016|027|H|with mild, non-medicated cleanser, rinse with warm water, and pat||
4016|028|H|dry. Apply a thin layer of this medication to the affected areas||
4016|029|H|of the skin as directed by your doctor. Be careful to avoid your||
4016|030|H|eyes, mouth, inside your nose, and any areas of broken skin. Wash||
4016|031|H|your hands after each use.||
4016|032|H|   Use this medication regularly to get the most benefit from it.||
4016|033|H|To help you remember, use it at the same time(s) each day.||
4016|034|H|   Do not increase your dose or use this drug more often or for||
4016|035|H|longer than prescribed. Your condition will not improve any||
4016|036|H|faster, and your risk of side effects will increase.||
4016|037|H|   It may take up to 6 weeks to see a decrease in acne and up to||
4016|038|H|12 weeks to see the full benefit of the medication.||
4016|039|H|   Tell your doctor if your condition does not get better or if||
4016|040|H|it gets worse.||
4016|041|B|||
4016|042|S|SIDE EFFECTS:  Dry skin, redness, burning, itching, or skin||
4016|043|S|peeling may occur. If any of these effects last or get worse,||
4016|044|S|tell your doctor or pharmacist promptly.||
4016|045|S|   You can use skin moisturizing creams or lotions to help reduce||
4016|046|S|many of the side effects listed above.||
4016|047|S|   Remember that this medication has been prescribed because your||
4016|048|S|doctor has judged that the benefit to you is greater than the||
4016|049|S|risk of side effects. Many people using this medication do not||
4016|050|S|have serious side effects.||
4016|051|S|   This medication may be absorbed into your bloodstream and very||
4016|052|S|rarely cause a severe intestinal condition due to a bacteria||
4016|053|S|called C. difficile. This condition may occur during treatment or||
4016|054|S|weeks to months after treatment has stopped. Tell your doctor||
4016|055|S|right away if you develop: diarrhea that doesn't stop, abdominal||
4016|056|S|or stomach pain/cramping, blood/mucus in your stool.||
4016|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4016|058|S|products because they may make symptoms worse.||
4016|059|S|   A very serious allergic reaction to this drug is rare.||
4016|060|S|However, get medical help right away if you notice any symptoms||
4016|061|S|of a serious allergic reaction, including: rash, itching/swelling||
4016|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4016|063|S|breathing.||
4016|064|S|   This is not a complete list of possible side effects. If you||
4016|065|S|notice other effects not listed above, contact your doctor or||
4016|066|S|pharmacist.||
4016|067|S|   In the US -||
4016|068|S|   Call your doctor for medical advice about side effects. You||
4016|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4016|070|S|www.fda.gov/medwatch.||
4016|071|S|   In Canada - Call your doctor for medical advice about side||
4016|072|S|effects. You may report side effects to Health Canada at||
4016|073|S|1-866-234-2345.||
4016|074|B|||
4016|075|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
4016|076|P|pharmacist if you are allergic to benzoyl peroxide; or to||
4016|077|P|clindamycin; or to lincomycin; or if you have any other||
4016|078|P|allergies. This product may contain inactive ingredients, which||
4016|079|P|can cause allergic reactions or other problems. Talk to your||
4016|080|P|pharmacist for more details.||
4016|081|P|   Before using this medication, tell your doctor or pharmacist||
4016|082|P|your medical history, especially of: intestinal disorders (such||
4016|083|P|as regional enteritis, ulcerative colitis, antibiotic-associated||
4016|084|P|colitis, C. difficile-associated diarrhea).||
4016|085|P|   This medication may make you more sensitive to the sun. Limit||
4016|086|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4016|087|P|sunscreen and wear protective clothing when outdoors. Tell your||
4016|088|P|doctor right away if you get sunburned or have skin||
4016|089|P|blisters/redness.||
4016|090|P|   This medication may bleach hair or colored fabric. Avoid||
4016|091|P|contact with hair or clothing.||
4016|092|P|   During pregnancy, this medication should be used only when||
4016|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
4016|094|P|   It is unknown if this form of clindamycin and benzoyl peroxide||
4016|095|P|passes into breast milk. If using this medication on the breast,||
4016|096|P|avoid using ointment forms of this medication. Consult your||
4016|097|P|doctor before breastfeeding.||
4016|098|B|||
4016|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4016|100|I|medications work or increase your risk for serious side effects.||
4016|101|I|This document does not contain all possible drug interactions.||
4016|102|I|Keep a list of all the products you use (including||
4016|103|I|prescription/nonprescription drugs and herbal products) and share||
4016|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
4016|105|I|the dosage of any medicines without your doctor's approval.||
4016|106|I|   Some products that may interact with this drug include: other||
4016|107|I|acne medications used on the skin (such as dapsone).||
4016|108|B|||
4016|109|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
4016|110|O|has overdosed and has serious symptoms such as passing out or||
4016|111|O|trouble breathing, call 911. Otherwise, call a poison control||
4016|112|O|center right away. US residents can call 1-800-222-1222. Canada||
4016|113|O|residents can call 1-844-764-7669.||
4016|114|B|||
4016|115|N|NOTES:  Do not share this medication with others.||
4016|116|B|||
4016|117|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4016|118|D|If it is near the time of the next dose, skip the missed dose.||
4016|119|D|Use your next dose at the regular time. Do not double the dose to||
4016|120|D|catch up.||
4016|121|B|||
4016|122|R|STORAGE:  Different brands of this medication have different||
4016|123|R|storage needs. Check the product package for instructions on how||
4016|124|R|to store your brand, or ask your pharmacist. This medication is||
4016|125|R|good for a limited time after you receive it. Discard any unused||
4016|126|R|medication by the expiration date your pharmacist provides. Keep||
4016|127|R|all medications away from children and pets.||
4016|128|R|   Do not flush medications down the toilet or pour them into a||
4016|129|R|drain unless instructed to do so. Properly discard this product||
4016|130|R|when it is expired or no longer needed. Consult your pharmacist||
4016|131|R|or local waste disposal company.||
4016|132|B|||
4016|133|A|Information last revised October 2024.||
4016|134|A|Copyright(c) 2025 First Databank, Inc.||
4016|135|B|||
4019|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4019|002|Z|does NOT have all possible information about this product. This||
4019|003|Z|information does not assure that this product is safe, effective,||
4019|004|Z|or appropriate for you. This information is not individual||
4019|005|Z|medical advice and does not substitute for the advice of your||
4019|006|Z|health care professional. Always ask your health care||
4019|007|Z|professional for complete information about this product and your||
4019|008|Z|specific health needs.||
4019|009|B|||
4019|010|T|LEVETIRACETAM - ORAL||
4019|011|F|(lev-eh-turr-RASS-ih-tam)||
4019|012|B|||
4019|013|C|COMMON BRAND NAME(S): Keppra||
4019|014|B|||
4019|015|U|USES:  Levetiracetam is used to treat seizures (epilepsy). It||
4019|016|U|belongs to a class of drugs known as anticonvulsants.||
4019|017|U|Levetiracetam may decrease the number of seizures you have.||
4019|018|B|||
4019|019|H|HOW TO USE:  Read the Medication Guide and, if available, the||
4019|020|H|Patient Information Leaflet provided by your pharmacist before||
4019|021|H|you start taking levetiracetam and each time you get a refill. If||
4019|022|H|you have any questions, ask your doctor or pharmacist.||
4019|023|H|   Take the liquid and regular-release tablets by mouth as||
4019|024|H|directed by your doctor, usually twice daily with or without||
4019|025|H|food. Crushing or chewing the tablet may cause a bitter taste.||
4019|026|H|   If you are using the liquid form of this medication, carefully||
4019|027|H|measure the dose using a special measuring device/spoon. Do not||
4019|028|H|use a household spoon because you may not get the correct dose.||
4019|029|H|   If you are using the extended-release tablets, take this||
4019|030|H|medication as directed by your doctor, usually once daily.||
4019|031|H|Swallow the extended-release tablets whole. Do not crush or chew||
4019|032|H|the tablets. Doing so can release all of the drug at once,||
4019|033|H|increasing the risk of side effects.||
4019|034|H|   The dosage is based on your medical condition and response to||
4019|035|H|treatment. Children's dosage is also based on weight. To reduce||
4019|036|H|your risk of side effects (such as dizziness and drowsiness),||
4019|037|H|your doctor may direct you to start this medication at a low dose||
4019|038|H|and gradually increase your dose. Follow your doctor's||
4019|039|H|instructions carefully.||
4019|040|H|   Use this medication regularly to get the most benefit from it.||
4019|041|H|To help you remember, take it at the same times each day.||
4019|042|H|   Do not increase your dose or use this drug more often or for||
4019|043|H|longer than prescribed. Your condition will not improve any||
4019|044|H|faster, and your risk of side effects will increase.||
4019|045|H|   Do not stop taking this medication without consulting your||
4019|046|H|doctor. Your seizures may become worse when the drug is suddenly||
4019|047|H|stopped. Your dose should be gradually decreased.||
4019|048|H|   Tell your doctor if your seizures lasts, change, or gets||
4019|049|H|worse.||
4019|050|B|||
4019|051|S|SIDE EFFECTS:  Drowsiness, dizziness, unusual tiredness, or||
4019|052|S|weakness may occur. These side effects are more common during the||
4019|053|S|first 4 weeks and usually lessen as your body adjusts to the||
4019|054|S|medication. If any of these effects last or get worse, tell your||
4019|055|S|doctor or pharmacist promptly.||
4019|056|S|   Remember that this medication has been prescribed because your||
4019|057|S|doctor has judged that the benefit to you is greater than the||
4019|058|S|risk of side effects. Many people using this medication do not||
4019|059|S|have serious side effects.||
4019|060|S|   Tell your doctor right away if you have any serious side||
4019|061|S|effects, such as: loss of coordination (such as difficulty||
4019|062|S|walking and controlling muscles), mental/mood changes (such as||
4019|063|S|irritability, aggression, agitation, anger, anxiety), signs of||
4019|064|S|anemia (such as unusual tiredness that doesn't go away, pale||
4019|065|S|skin, fast breathing, fast heartbeat), easy bruising/bleeding.||
4019|066|S|   A small number of people who take anticonvulsants for any||
4019|067|S|condition (such as seizures, bipolar disorder, pain) may||
4019|068|S|experience depression, suicidal thoughts/attempts, or other||
4019|069|S|mental/mood problems. Tell your doctor right away if you or your||
4019|070|S|family/caregiver notice any unusual/sudden changes in your mood,||
4019|071|S|thoughts, or behavior including signs of depression, suicidal||
4019|072|S|thoughts/attempts, thoughts about harming yourself.||
4019|073|S|   Levetiracetam can commonly cause a rash that is usually not||
4019|074|S|serious. However, you may not be able to tell it apart from a||
4019|075|S|rare rash that could be a sign of a severe reaction. Tell your||
4019|076|S|doctor right away if you develop any rash.||
4019|077|S|   A very serious allergic reaction to this drug is rare.||
4019|078|S|However, get medical help right away if you notice any symptoms||
4019|079|S|of a serious allergic reaction, such as: fever, swollen lymph||
4019|080|S|nodes, rash, itching/swelling (especially of the||
4019|081|S|face/tongue/throat), severe dizziness, trouble breathing.||
4019|082|S|   This is not a complete list of possible side effects. If you||
4019|083|S|notice other effects not listed above, contact your doctor or||
4019|084|S|pharmacist.||
4019|085|S|   In the US -||
4019|086|S|   Call your doctor for medical advice about side effects. You||
4019|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4019|088|S|www.fda.gov/medwatch.||
4019|089|S|   In Canada - Call your doctor for medical advice about side||
4019|090|S|effects. You may report side effects to Health Canada at||
4019|091|S|1-866-234-2345.||
4019|092|B|||
4019|093|P|PRECAUTIONS:  Before taking levetiracetam, tell your doctor or||
4019|094|P|pharmacist if you are allergic to it; or if you have any other||
4019|095|P|allergies. This product may contain inactive ingredients, which||
4019|096|P|can cause allergic reactions or other problems. Talk to your||
4019|097|P|pharmacist for more details.||
4019|098|P|   Before using this medication, tell your doctor or pharmacist||
4019|099|P|your medical history, especially of: kidney disease (such as||
4019|100|P|dialysis treatment), mental/mood disorders (such as depression).||
4019|101|P|   This drug may make you dizzy or drowsy, especially during the||
4019|102|P|first month of treatment. Alcohol or marijuana (cannabis) can||
4019|103|P|make you more dizzy or drowsy. Do not drive, use machinery, ride||
4019|104|P|a bicycle, or do anything that needs alertness until you can do||
4019|105|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
4019|106|P|are using marijuana (cannabis).||
4019|107|P|   Before having surgery, tell your doctor or dentist about all||
4019|108|P|the products you use (including prescription drugs,||
4019|109|P|nonprescription drugs, and herbal products).||
4019|110|P|   Children may be more sensitive to the side effects of the||
4019|111|P|drug, especially mental/mood changes (such as irritability,||
4019|112|P|aggression, agitation, anger, anxiety, depression, thoughts of||
4019|113|P|suicide). Children younger than 4 years may be at greater risk||
4019|114|P|for increased blood pressure while using this drug (see also||
4019|115|P|Notes section).||
4019|116|P|   Older adults may be more sensitive to the side effects of this||
4019|117|P|drug, especially drowsiness, dizziness or loss of coordination.||
4019|118|P|These side effects can increase the risk of falling.||
4019|119|P|   During pregnancy, this medication should be used only when||
4019|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
4019|121|P|   This medication passes into breast milk. Consult your doctor||
4019|122|P|before breastfeeding.||
4019|123|B|||
4019|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4019|125|I|medications work or increase your risk for serious side effects.||
4019|126|I|This document does not contain all possible drug interactions.||
4019|127|I|Keep a list of all the products you use (including||
4019|128|I|prescription/nonprescription drugs and herbal products) and share||
4019|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
4019|130|I|the dosage of any medicines without your doctor's approval.||
4019|131|I|   A product that may interact with this drug is: orlistat.||
4019|132|B|||
4019|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4019|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4019|135|O|poison control center right away. US residents can call||
4019|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4019|137|O|Symptoms of overdose may include slow/shallow breathing, loss of||
4019|138|O|consciousness.||
4019|139|B|||
4019|140|N|NOTES:  Do not share this medication with others.||
4019|141|N|   Lab and/or medical tests (such as kidney function, complete||
4019|142|N|blood count) may be done while you are taking this medication. In||
4019|143|N|children younger than 4 years, blood pressure may also be||
4019|144|N|monitored. Consult your doctor for more details.||
4019|145|B|||
4019|146|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4019|147|D|remember. If it is near the time of the next dose, skip the||
4019|148|D|missed dose. Take your next dose at the regular time. Do not||
4019|149|D|double the dose to catch up.||
4019|150|B|||
4019|151|R|STORAGE:  Store at room temperature away from light and moisture.||
4019|152|R|Do not store in the bathroom. Keep all medications away from||
4019|153|R|children and pets.||
4019|154|R|   Do not flush medications down the toilet or pour them into a||
4019|155|R|drain unless instructed to do so. Properly discard this product||
4019|156|R|when it is expired or no longer needed. Consult your pharmacist||
4019|157|R|or local waste disposal company.||
4019|158|B|||
4019|159|M|MEDICAL ALERT:  Your condition can cause complications in a||
4019|160|M|medical emergency. For information about enrolling in MedicAlert,||
4019|161|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4019|162|B|||
4019|163|A|Information last revised August 2024.||
4019|164|A|Copyright(c) 2025 First Databank, Inc.||
4019|165|B|||
4021|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4021|002|Z|does NOT have all possible information about this product. This||
4021|003|Z|information does not assure that this product is safe, effective,||
4021|004|Z|or appropriate for you. This information is not individual||
4021|005|Z|medical advice and does not substitute for the advice of your||
4021|006|Z|health care professional. Always ask your health care||
4021|007|Z|professional for complete information about this product and your||
4021|008|Z|specific health needs.||
4021|009|B|||
4021|010|T|METHYLPREDNISOLONE SODIUM SUCCINATE - INJECTION||
4021|011|F|(METH-il-pred-NIS-oh-lone SOE-dee-um SUX-i-nate)||
4021|012|B|||
4021|013|C|COMMON BRAND NAME(S): Solu-Medrol||
4021|014|B|||
4021|015|U|USES:  This medication is used to treat conditions such as||
4021|016|U|arthritis, blood disorders, severe allergic reactions, certain||
4021|017|U|cancers, eye conditions, skin/kidney/intestinal/lung diseases,||
4021|018|U|and immune system disorders. It decreases your immune system's||
4021|019|U|response to various diseases to reduce symptoms such as swelling,||
4021|020|U|pain, and allergic-type reactions. Methylprednisolone is a||
4021|021|U|corticosteroid hormone. This injectable form of||
4021|022|U|methylprednisolone is used when a similar drug cannot be taken by||
4021|023|U|mouth or when a very fast response is needed, especially in||
4021|024|U|patients with severe medical conditions. Talk to your doctor||
4021|025|U|about the risks and benefits of methylprednisolone, especially if||
4021|026|U|it is to be injected near your spine (epidural). Rare but serious||
4021|027|U|side effects may occur with epidural use.||
4021|028|U|   Methylprednisolone may also be used with other medications in||
4021|029|U|hormone disorders.||
4021|030|B|||
4021|031|V|OTHER USES:  This section contains uses of this drug that are not||
4021|032|V|listed in the approved professional labeling for the drug but||
4021|033|V|that may be prescribed by your health care professional. Use this||
4021|034|V|drug for a condition that is listed in this section only if it||
4021|035|V|has been so prescribed by your health care professional.||
4021|036|V|   Methylprednisolone may also be used for COVID-19, but is only||
4021|037|V|effective in hospitalized patients who need supplemental oxygen||
4021|038|V|or a mechanical ventilator to breathe.||
4021|039|B|||
4021|040|H|HOW TO USE:  This medication is usually given by slow injection||
4021|041|H|into a vein or directly into a muscle, as directed by your||
4021|042|H|doctor. The dosage is based on your medical condition and||
4021|043|H|response to treatment. Do not increase your dose or use this drug||
4021|044|H|more often than prescribed without consulting your doctor. Your||
4021|045|H|condition will not improve any faster, and your risk of side||
4021|046|H|effects will increase.||
4021|047|H|   If you are using this medication at home, learn all||
4021|048|H|preparation and usage instructions from your health care||
4021|049|H|professional. Before using, check this product for particles or||
4021|050|H|discoloration. If either is present, do not use the liquid. Learn||
4021|051|H|how to store and discard medical supplies safely.||
4021|052|H|   Do not stop using this medication without consulting your||
4021|053|H|doctor. Some conditions may become worse when this drug is||
4021|054|H|suddenly stopped. Your dose may need to be gradually decreased.||
4021|055|H|   If you suddenly stop using this medication, you may have||
4021|056|H|withdrawal symptoms (such as weakness, weight loss, nausea,||
4021|057|H|muscle pain, headache, tiredness, dizziness). To help prevent||
4021|058|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
4021|059|H|more likely if you have used methylprednisolone for a long time||
4021|060|H|or in high doses. Tell your doctor or pharmacist right away if||
4021|061|H|you have withdrawal. See also Precautions section.||
4021|062|H|   Tell your doctor if your condition does not get better or if||
4021|063|H|it gets worse.||
4021|064|B|||
4021|065|S|SIDE EFFECTS:  Nausea, vomiting, heartburn, headache, dizziness,||
4021|066|S|trouble sleeping, appetite changes, increased sweating, acne, or||
4021|067|S|pain/redness/swelling at the injection site may occur. If any of||
4021|068|S|these effects last or get worse, tell your doctor or pharmacist||
4021|069|S|promptly.||
4021|070|S|   Remember that this medication has been prescribed because your||
4021|071|S|doctor has judged that the benefit to you is greater than the||
4021|072|S|risk of side effects. Many people using this medication do not||
4021|073|S|have serious side effects.||
4021|074|S|   This medication may make your blood sugar rise, which can||
4021|075|S|cause or worsen diabetes. Tell your doctor right away if you have||
4021|076|S|symptoms of high blood sugar such as increased thirst/urination.||
4021|077|S|If you already have diabetes, check your blood sugar regularly as||
4021|078|S|directed and share the results with your doctor. Your doctor may||
4021|079|S|need to adjust your diabetes medication, exercise program, or||
4021|080|S|diet.||
4021|081|S|   This medication may lower your ability to fight infections.||
4021|082|S|This may make you more likely to get a serious (rarely fatal)||
4021|083|S|infection or make any infection you have worse. Tell your doctor||
4021|084|S|right away if you have any signs of infection (such as sore||
4021|085|S|throat that doesn't go away, fever, chills, white patches in the||
4021|086|S|mouth).||
4021|087|S|   Tell your doctor right away if you have any serious side||
4021|088|S|effects, including: unusual weight gain, menstrual period||
4021|089|S|changes, bone/joint pain, easy bruising/bleeding, mental/mood||
4021|090|S|changes (such as mood swings, depression, agitation), muscle||
4021|091|S|weakness/pain, puffy face, slow wound healing, swelling of the||
4021|092|S|ankles/feet/hands, thinning skin, unusual hair/skin growth,||
4021|093|S|vision problems, fast/slow/irregular heartbeat, symptoms of||
4021|094|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
4021|095|S|black/tarry stools, vomit that looks like coffee grounds),||
4021|096|S|red/purple spots on the skin.||
4021|097|S|   Get medical help right away if you have any very serious side||
4021|098|S|effects, including: seizures.||
4021|099|S|   This medication may rarely cause serious liver problems. Tell||
4021|100|S|your doctor right way if you experience: nausea/vomiting that||
4021|101|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
4021|102|S|eyes/skin, dark urine.||
4021|103|S|   A very serious allergic reaction to this drug is rare.||
4021|104|S|However, get medical help right away if you notice any symptoms||
4021|105|S|of a serious allergic reaction, including: rash, itching/swelling||
4021|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4021|107|S|breathing.||
4021|108|S|   This is not a complete list of possible side effects. If you||
4021|109|S|notice other effects not listed above, contact your doctor or||
4021|110|S|pharmacist.||
4021|111|S|   In the US -||
4021|112|S|   Call your doctor for medical advice about side effects. You||
4021|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4021|114|S|www.fda.gov/medwatch.||
4021|115|S|   In Canada - Call your doctor for medical advice about side||
4021|116|S|effects. You may report side effects to Health Canada at||
4021|117|S|1-866-234-2345.||
4021|118|B|||
4021|119|P|PRECAUTIONS:  Before using methylprednisolone, tell your doctor||
4021|120|P|or pharmacist if you are allergic to it; or to prednisone; or if||
4021|121|P|you have any other allergies. This product may contain inactive||
4021|122|P|ingredients (such as lactose or cow's milk protein found in some||
4021|123|P|products), which can cause allergic reactions or other problems.||
4021|124|P|Talk to your pharmacist for more details.||
4021|125|P|   Before using this medication, tell your doctor or pharmacist||
4021|126|P|your medical history, especially of: bleeding problems, blood||
4021|127|P|clots, brittle bones (osteoporosis), diabetes, eye diseases (such||
4021|128|P|as cataracts, glaucoma, herpes infection of the eye), heart||
4021|129|P|problems (such as heart failure, recent heart attack), high blood||
4021|130|P|pressure, current/ past infections (such as those caused by||
4021|131|P|tuberculosis, threadworm, herpes, fungus), kidney disease, liver||
4021|132|P|disease (such as hepatitis B), mental/mood conditions (such as||
4021|133|P|psychosis, anxiety, depression), stomach/intestinal problems||
4021|134|P|(such as diverticulitis, ulcer, ulcerative colitis), seizures, a||
4021|135|P|certain adrenal gland tumor (pheochromocytoma).||
4021|136|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4021|137|P|can make you more dizzy. Do not drive, use machinery, or do||
4021|138|P|anything that needs alertness until you can do it safely. Talk to||
4021|139|P|your doctor if you are using marijuana (cannabis).||
4021|140|P|   This medication may cause stomach bleeding. Daily use of||
4021|141|P|alcohol while using this medication may increase your risk for||
4021|142|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
4021|143|P|or pharmacist for more information.||
4021|144|P|   Methylprednisolone can make you more likely to get infections||
4021|145|P|or may make current infections worse. Stay away from anyone who||
4021|146|P|has an infection that may easily spread (such as chickenpox,||
4021|147|P|COVID-19, measles, flu). Talk to your doctor if you have been||
4021|148|P|exposed to an infection or for more details.||
4021|149|P|   Tell your health care professional that you are using||
4021|150|P|methylprednisolone before having any immunizations, vaccinations,||
4021|151|P|or skin tests. Avoid contact with people who have recently||
4021|152|P|received live vaccines (such as flu vaccine inhaled through the||
4021|153|P|nose).||
4021|154|P|   Before having surgery, tell your doctor or dentist about all||
4021|155|P|the products you use (including prescription drugs,||
4021|156|P|nonprescription drugs, and herbal products).||
4021|157|P|   Using corticosteroid medications for a long time can make it||
4021|158|P|more difficult for your body to respond to physical stress.||
4021|159|P|Before having surgery or emergency treatment, or if you get a||
4021|160|P|serious illness/injury, tell your doctor or dentist that you are||
4021|161|P|using this medication or have used this medication within the||
4021|162|P|past 12 months. Tell your doctor right away if you develop||
4021|163|P|unusual/extreme tiredness or weight loss. If you will be using||
4021|164|P|this medication for a long time, carry a warning card or medical||
4021|165|P|ID bracelet that identifies your use of this medication. See also||
4021|166|P|Medical Alert section.||
4021|167|P|   Older adults may be more sensitive to the side effects of this||
4021|168|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
4021|169|P|mental/mood changes (such as confusion).||
4021|170|P|   This medication may slow down a child's growth if used for a||
4021|171|P|long time. Consult the doctor or pharmacist for more details. See||
4021|172|P|the doctor regularly so your child's height and growth can be||
4021|173|P|checked.||
4021|174|P|   During pregnancy, this medication should be used only when||
4021|175|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
4021|176|P|risks and benefits with your doctor. Infants born to mothers who||
4021|177|P|use this medication for a long time during pregnancy may have||
4021|178|P|hormone problems. Tell your doctor right away if you notice||
4021|179|P|symptoms such as nausea/vomiting that doesn't stop, severe||
4021|180|P|diarrhea, or weakness in your newborn.||
4021|181|P|   This medication passes into breast milk but is unlikely to||
4021|182|P|harm a nursing infant. Consult your doctor before breastfeeding.||
4021|183|B|||
4021|184|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4021|185|I|medications work or increase your risk for serious side effects.||
4021|186|I|This document does not contain all possible drug interactions.||
4021|187|I|Keep a list of all the products you use (including||
4021|188|I|prescription/nonprescription drugs and herbal products) and share||
4021|189|I|it with your doctor and pharmacist. Do not start, stop, or change||
4021|190|I|the dosage of any medicines without your doctor's approval.||
4021|191|I|   Some products that may interact with this drug include:||
4021|192|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
4021|193|I|also cause bleeding/bruising (including antiplatelet drugs such||
4021|194|I|as clopidogrel, "blood thinners" such as warfarin/dabigatran,||
4021|195|I|NSAIDs such as ibuprofen, celecoxib, aspirin, salicylates).||
4021|196|I|   If your doctor has told you to take low-dose aspirin to||
4021|197|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
4021|198|I|you should keep taking the aspirin unless your doctor tells you||
4021|199|I|not to. Ask your doctor or pharmacist for more details.||
4021|200|I|   Other medications can affect the removal of methylprednisolone||
4021|201|I|from your body, which may affect how methylprednisolone works.||
4021|202|I|Examples include azole antifungals (such as ketoconazole),||
4021|203|I|cyclosporine, estrogens, HIV protease inhibitors (such as||
4021|204|I|darunavir), macrolide antibiotics (such as erythromycin),||
4021|205|I|ritonavir, St. John's wort, some drugs used to treat seizures||
4021|206|I|(such as phenytoin, phenobarbital), among others.||
4021|207|I|   This medication may interfere with certain lab tests (such as||
4021|208|I|skin tests), possibly causing false test results. Make sure lab||
4021|209|I|personnel and all your doctors know you use this drug.||
4021|210|B|||
4021|211|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4021|212|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4021|213|O|poison control center right away. US residents can call||
4021|214|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4021|215|B|||
4021|216|N|NOTES:  Do not share this medication with others.||
4021|217|N|   If this medication is used for a long time, lab and/or medical||
4021|218|N|tests (such as blood sugar/mineral levels, blood pressure, eye||
4021|219|N|exams, bone density tests, height/weight measurements) should be||
4021|220|N|done while you are using this medication. Keep all medical and||
4021|221|N|lab appointments. Consult your doctor for more details.||
4021|222|N|   This medication may cause bone loss (osteoporosis) when used||
4021|223|N|for a long time. Lifestyle changes that may help reduce the risk||
4021|224|N|of bone problems include doing weight-bearing exercise, stopping||
4021|225|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
4021|226|N|D. Talk to your doctor for more details.||
4021|227|B|||
4021|228|D|MISSED DOSE:  It is important to get each dose of this medication||
4021|229|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
4021|230|D|right away for a new dosing schedule. Do not double the dose to||
4021|231|D|catch up.||
4021|232|B|||
4021|233|R|STORAGE:  Store the unmixed medication at room temperature away||
4021|234|R|from light. Store the mixed medication at room temperature away||
4021|235|R|from light. Discard any unused portion after 48 hours. Keep all||
4021|236|R|medications away from children and pets.||
4021|237|R|   Do not flush medications down the toilet or pour them into a||
4021|238|R|drain unless instructed to do so. Properly discard this product||
4021|239|R|when it is expired or no longer needed. Consult your pharmacist||
4021|240|R|or local waste disposal company.||
4021|241|B|||
4021|242|A|Information last revised September 2025.||
4021|243|A|Copyright(c) 2025 First Databank, Inc.||
4021|244|B|||
4025|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4025|002|Z|does NOT have all possible information about this product. This||
4025|003|Z|information does not assure that this product is safe, effective,||
4025|004|Z|or appropriate for you. This information is not individual||
4025|005|Z|medical advice and does not substitute for the advice of your||
4025|006|Z|health care professional. Always ask your health care||
4025|007|Z|professional for complete information about this product and your||
4025|008|Z|specific health needs.||
4025|009|B|||
4025|010|T|LOPERAMIDE - ORAL||
4025|011|F|(low-PAIR-uh-mide)||
4025|012|B|||
4025|013|C|COMMON BRAND NAME(S): Imodium||
4025|014|B|||
4025|015|W|WARNING:  Improper use of this medication (overuse or abuse) may||
4025|016|W|cause serious harm, such as fast/irregular heartbeat or death. Do||
4025|017|W|not increase your dose, take it more often, or take it for longer||
4025|018|W|than directed. Taking loperamide with certain other medications||
4025|019|W|may also cause harm. See also Precautions, Drug Interactions, and||
4025|020|W|Overdose sections.||
4025|021|W|   This medication should not be used by children younger than 2||
4025|022|W|years due to an increased risk of side effects (such as||
4025|023|W|slow/shallow breathing, fast/irregular heartbeat).||
4025|024|B|||
4025|025|U|USES:  See also Warning section.||
4025|026|U|   This medication is used to treat sudden diarrhea (including||
4025|027|U|traveler's diarrhea). It works by slowing down the movement of||
4025|028|U|the gut. This decreases the number of bowel movements and makes||
4025|029|U|the stool less watery. Loperamide is also used to reduce the||
4025|030|U|amount of discharge in patients who have undergone an ileostomy.||
4025|031|U|It is also used to treat on-going diarrhea in people with||
4025|032|U|inflammatory bowel disease.||
4025|033|U|   Loperamide treats only the symptoms, not the cause of the||
4025|034|U|diarrhea (such as infection). Treatment of other symptoms and the||
4025|035|U|cause of the diarrhea should be determined by your doctor.||
4025|036|B|||
4025|037|H|HOW TO USE:  See also Warning section.||
4025|038|H|   If you are using the over-the-counter product to self-treat,||
4025|039|H|read all the directions on the product package before taking this||
4025|040|H|medication. If your doctor has prescribed this medication, follow||
4025|041|H|your doctor's directions and the directions on your prescription||
4025|042|H|label.||
4025|043|H|   Take this medication by mouth, usually after each loose stool,||
4025|044|H|or as directed by your doctor. The dosage is based on your||
4025|045|H|condition and response to treatment. Children's dosage is also||
4025|046|H|based on age and weight. Adults should not use more than 8||
4025|047|H|milligrams in 24 hours if self-treating, or 16 milligrams in 24||
4025|048|H|hours if under a doctor's direction.||
4025|049|H|   If you are taking the chewable tablet, take this medication on||
4025|050|H|an empty stomach. The chewable tablets should be chewed||
4025|051|H|thoroughly before swallowing.||
4025|052|H|   If you are using the rapidly dissolving tablets, dry your||
4025|053|H|hands before opening the blister pack to carefully remove a||
4025|054|H|tablet. Do not push the tablet through the blister pack. Place||
4025|055|H|the tablet on the tongue, allow it to dissolve completely, then||
4025|056|H|swallow it with saliva. Do not crush, split, or break the tablet||
4025|057|H|before taking it. Do not remove the tablet from the blister pack||
4025|058|H|until just before taking. No water is needed to take this||
4025|059|H|medication.||
4025|060|H|   Diarrhea can cause dehydration. Drink plenty of fluids and||
4025|061|H|minerals (electrolytes) to replace what is lost. Tell your doctor||
4025|062|H|right away if you develop signs of dehydration (such as extreme||
4025|063|H|thirst, decreased urination, muscle cramps, weakness, fainting).||
4025|064|H|You may also need to change to a bland diet during this time to||
4025|065|H|reduce irritation to your stomach/intestines. Consult your doctor||
4025|066|H|or pharmacist for more information.||
4025|067|H|   Tell your doctor if your diarrhea does not get better after 2||
4025|068|H|days, if your condition gets worse, or if you develop new||
4025|069|H|symptoms. If you develop blood in the stool, fever, or an||
4025|070|H|uncomfortable fullness/swelling of the stomach/abdomen, or if you||
4025|071|H|think you may have a serious medical problem, get medical help||
4025|072|H|right away.||
4025|073|H|   If you are taking this medication under your doctor's||
4025|074|H|direction for ongoing diarrhea, tell your doctor if your diarrhea||
4025|075|H|continues after 10 days of treatment.||
4025|076|B|||
4025|077|S|SIDE EFFECTS:  Dizziness, drowsiness, tiredness, or constipation||
4025|078|S|may occur. If any of these effects last or get worse, tell your||
4025|079|S|doctor promptly.||
4025|080|S|   If your doctor has prescribed this medication, remember that||
4025|081|S|your doctor has judged that the benefit to you is greater than||
4025|082|S|the risk of side effects. Many people using this medication do||
4025|083|S|not have serious side effects.||
4025|084|S|   Stop taking this medication and get medical help right away if||
4025|085|S|you have any very serious side effects, including: severe||
4025|086|S|constipation/nausea/vomiting, stomach/abdominal pain,||
4025|087|S|uncomfortable fullness of the stomach/abdomen, fast/irregular||
4025|088|S|heartbeat, severe dizziness, fainting.||
4025|089|S|   A very serious allergic reaction to this drug is rare.||
4025|090|S|However, get medical help right away if you notice any symptoms||
4025|091|S|of a serious allergic reaction, including: rash, itching/swelling||
4025|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4025|093|S|breathing.||
4025|094|S|   This is not a complete list of possible side effects. If you||
4025|095|S|notice other effects not listed above, contact your doctor or||
4025|096|S|pharmacist.||
4025|097|S|   In the US -||
4025|098|S|   Call your doctor for medical advice about side effects. You||
4025|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4025|100|S|www.fda.gov/medwatch.||
4025|101|S|   In Canada - Call your doctor for medical advice about side||
4025|102|S|effects. You may report side effects to Health Canada at||
4025|103|S|1-866-234-2345.||
4025|104|B|||
4025|105|P|PRECAUTIONS:  Before taking loperamide, tell your doctor or||
4025|106|P|pharmacist if you are allergic to it; or if you have any other||
4025|107|P|allergies. This product may contain inactive ingredients, which||
4025|108|P|can cause allergic reactions or other problems. Talk to your||
4025|109|P|pharmacist for more details.||
4025|110|P|   If you have any of the following health problems, consult your||
4025|111|P|doctor or pharmacist before using this medication:||
4025|112|P|stomach/abdominal pain without diarrhea, bowel obstruction (such||
4025|113|P|as ileus, megacolon, abdominal distention), black/tarry stool,||
4025|114|P|blood/mucus in your stool, high fever, HIV infection/AIDS, liver||
4025|115|P|problems, certain stomach/intestinal infections (such as||
4025|116|P|Salmonella, Shigella), certain type of bowel disease (acute||
4025|117|P|ulcerative colitis).||
4025|118|P|   The rapidly dissolving tablets may contain aspartame or||
4025|119|P|phenylalanine. If you have phenylketonuria (PKU) or any other||
4025|120|P|condition that requires you to restrict your intake of aspartame||
4025|121|P|or phenylalanine, consult your doctor or pharmacist regarding the||
4025|122|P|safe use of this medicine.||
4025|123|P|   Antibiotics may rarely cause a severe intestinal condition due||
4025|124|P|to a bacteria called C. difficile. Symptoms include: diarrhea||
4025|125|P|that doesn't stop, abdominal or stomach pain/cramping, or||
4025|126|P|blood/mucus in your stool. This condition may occur during||
4025|127|P|treatment or weeks to months after treatment has stopped. This||
4025|128|P|medication may make this condition worse. Do not use this||
4025|129|P|anti-diarrhea product, especially after recent antibiotic use, if||
4025|130|P|you have the above symptoms without talking with your doctor||
4025|131|P|first.||
4025|132|P|   Loperamide may cause a condition that affects the heart rhythm||
4025|133|P|(QT prolongation). QT prolongation can rarely cause serious||
4025|134|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
4025|135|P|as severe dizziness, fainting) that need medical attention right||
4025|136|P|away.||
4025|137|P|   The risk of QT prolongation may be increased if you have||
4025|138|P|certain medical conditions or are taking other drugs that may||
4025|139|P|cause QT prolongation. Before using loperamide, tell your doctor||
4025|140|P|or pharmacist of all the drugs you take and if you have any of||
4025|141|P|the following conditions: certain heart problems (heart failure,||
4025|142|P|slow heartbeat, QT prolongation in the EKG), family history of||
4025|143|P|certain heart problems (QT prolongation in the EKG, sudden||
4025|144|P|cardiac death).||
4025|145|P|   Low levels of potassium or magnesium in the blood may also||
4025|146|P|increase your risk of QT prolongation. This risk may increase if||
4025|147|P|you use certain drugs (such as diuretics/"water pills") or if you||
4025|148|P|have conditions such as severe sweating, diarrhea, or vomiting.||
4025|149|P|Talk to your doctor about using loperamide safely.||
4025|150|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4025|151|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4025|152|P|machinery, or do anything that needs alertness until you can do||
4025|153|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
4025|154|P|are using marijuana (cannabis).||
4025|155|P|   Older adults may be more sensitive to the side effects of this||
4025|156|P|drug, especially QT prolongation (see above).||
4025|157|P|   Children may be more sensitive to the side effects of this||
4025|158|P|drug, especially drowsiness. Children are also at a higher risk||
4025|159|P|for dehydration. See also Warning and How to Use sections.||
4025|160|P|   During pregnancy, this medication should be used only if||
4025|161|P|clearly needed. Discuss the risks and benefits with your doctor.||
4025|162|P|   This drug passes into breast milk but is unlikely to harm a||
4025|163|P|nursing infant. Consult your doctor before breastfeeding.||
4025|164|B|||
4025|165|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4025|166|I|medications work or increase your risk for serious side effects.||
4025|167|I|This document does not contain all possible drug interactions.||
4025|168|I|Keep a list of all the products you use (including||
4025|169|I|prescription/nonprescription drugs and herbal products) and share||
4025|170|I|it with your doctor and pharmacist. Do not start, stop, or change||
4025|171|I|the dosage of any medicines without your doctor's approval.||
4025|172|I|   Some products that may interact with this drug include:||
4025|173|I|pramlintide, recent/current antibiotic use, cholestyramine,||
4025|174|I|ritonavir.||
4025|175|I|   Many drugs besides loperamide may affect the heart rhythm (QT||
4025|176|I|prolongation), including amiodarone, chlorpromazine, haloperidol,||
4025|177|I|methadone, moxifloxacin, pentamidine, procainamide, quinidine,||
4025|178|I|sotalol, thioridazine, ziprasidone, among others.||
4025|179|B|||
4025|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4025|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4025|182|O|poison control center right away. US residents can call||
4025|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4025|184|O|Symptoms of overdose may include: difficult urination, slowed||
4025|185|O|breathing, deep sleep, fast/irregular heartbeat, severe||
4025|186|O|dizziness, fainting.||
4025|187|B|||
4025|188|N|NOTES:  If your doctor has prescribed this medication for you, do||
4025|189|N|not share it with others.||
4025|190|B|||
4025|191|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
4025|192|D|(not "as needed") and you miss a dose, take it as soon as you||
4025|193|D|remember. If it is near the time of the next dose, skip the||
4025|194|D|missed dose. Take your next dose at the regular time. Do not||
4025|195|D|double the dose to catch up.||
4025|196|B|||
4025|197|R|STORAGE:  Store at room temperature away from light and moisture.||
4025|198|R|Do not store in the bathroom. Keep all medications away from||
4025|199|R|children and pets.||
4025|200|R|   Do not flush medications down the toilet or pour them into a||
4025|201|R|drain unless instructed to do so. Properly discard this product||
4025|202|R|when it is expired or no longer needed. Consult your pharmacist||
4025|203|R|or local waste disposal company.||
4025|204|B|||
4025|205|A|Information last revised November 2024.||
4025|206|A|Copyright(c) 2025 First Databank, Inc.||
4025|207|B|||
4027|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4027|002|Z|does NOT have all possible information about this product. This||
4027|003|Z|information does not assure that this product is safe, effective,||
4027|004|Z|or appropriate for you. This information is not individual||
4027|005|Z|medical advice and does not substitute for the advice of your||
4027|006|Z|health care professional. Always ask your health care||
4027|007|Z|professional for complete information about this product and your||
4027|008|Z|specific health needs.||
4027|009|B|||
4027|010|T|METHYLTESTOSTERONE W/ ESTROGEN - ORAL||
4027|011|F|(METH-ill-tess-TOSS-ter-own/ESS-trow-jen)||
4027|012|B|||
4027|013|C|COMMON BRAND NAME(S): Covaryx, Estratest H.S., EEMT, Menogen H.S.||
4027|014|B|||
4027|015|W|WARNING:  Estrogens given alone and with another hormone||
4027|016|W|(progestin) for replacement therapy after menopause have||
4027|017|W|sometimes caused rare but very serious side effects. Discuss the||
4027|018|W|risks and benefits of hormone treatment and your personal health||
4027|019|W|history with your doctor.||
4027|020|W|   Estrogens have been reported to increase the chance of cancer||
4027|021|W|of the uterus (endometrial cancer). Taking a progestin with||
4027|022|W|estrogen decreases this risk. Tell your doctor right away if you||
4027|023|W|have any unusual vaginal bleeding.||
4027|024|W|   In postmenopausal women, estrogens, taken with or without a||
4027|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
4027|026|W|stroke, dementia, and serious blood clots. When used along with a||
4027|027|W|progestin, estrogens also increase the risk of heart disease||
4027|028|W|(such as heart attacks). Some of these risks appear to depend on||
4027|029|W|the length of time this drug is used and the amount of estrogen||
4027|030|W|per dose. This medication should be used for the shortest||
4027|031|W|possible length of time at the lowest effective dose, so you can||
4027|032|W|obtain the benefits and reduce the chance of serious side effects||
4027|033|W|from long-term treatment. Discuss the details with your doctor||
4027|034|W|and check with him/her regularly (such as every 3 to 6 months) to||
4027|035|W|see if you still need to take this medication.||
4027|036|W|   Products that contain estrogen should not be used to prevent||
4027|037|W|heart disease or dementia.||
4027|038|W|   If you use this drug for an extended period, you should have a||
4027|039|W|complete physical exam at regular intervals (such as once a year)||
4027|040|W|or as directed by your doctor. See Notes section.||
4027|041|B|||
4027|042|U|USES:  This medication is used for the short-term treatment of||
4027|043|U|menopause symptoms. It helps reduce episodes of flushing and||
4027|044|U|sweating of the upper body and face, commonly called hot flashes.||
4027|045|U|It also helps treat dryness, itching, and burning around the||
4027|046|U|vagina. These symptoms occur when a woman's body no longer||
4027|047|U|produces the usual amount of hormone (estrogen) at the age when||
4027|048|U|monthly menstrual periods normally stop. This medication is a||
4027|049|U|combination of 2 hormones, estrogen and methyltestosterone.||
4027|050|U|   If you need treatment only for vaginal menopause symptoms,||
4027|051|U|products applied directly inside the vagina should be considered||
4027|052|U|before medications that are taken by mouth, absorbed through the||
4027|053|U|skin, or injected.||
4027|054|B|||
4027|055|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4027|056|H|from your pharmacist before you start using this medication and||
4027|057|H|each time you get a refill. If you have any questions, ask your||
4027|058|H|doctor or pharmacist.||
4027|059|H|   Take this medication by mouth as directed by your doctor. This||
4027|060|H|medication is usually taken on a cycle, once a day for 21 days||
4027|061|H|followed by no medication for 7 days. Follow your dosing schedule||
4027|062|H|carefully. This drug should be used for the shortest possible||
4027|063|H|length of time. See also Warning section.||
4027|064|H|   This medication may be taken with or without food. You may||
4027|065|H|take it with food or immediately after a meal to prevent stomach||
4027|066|H|upset.||
4027|067|H|   Take this medication regularly in order to get the most||
4027|068|H|benefit from it. Remember to take it at the same time each day as||
4027|069|H|directed. The dosage is based on your medical condition and||
4027|070|H|response to treatment.||
4027|071|H|   Tell your doctor if your condition does not get better or if||
4027|072|H|it gets worse.||
4027|073|B|||
4027|074|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, stomach||
4027|075|S|upset, bloating, nausea, weight changes, increased/decreased||
4027|076|S|interest in sex, or breast tenderness may occur. If any of these||
4027|077|S|effects last or get worse, tell your doctor or pharmacist||
4027|078|S|promptly.||
4027|079|S|   This medication may raise your blood pressure. Check your||
4027|080|S|blood pressure regularly and tell your doctor if the results are||
4027|081|S|high. Your doctor may control your blood pressure with||
4027|082|S|medication.||
4027|083|S|   Remember that this medication has been prescribed because your||
4027|084|S|doctor has judged that the benefit to you is greater than the||
4027|085|S|risk of side effects. Many people using this medication do not||
4027|086|S|have serious side effects.||
4027|087|S|   Tell your doctor right away if you have any serious side||
4027|088|S|effects, including: signs of liver disease (such as||
4027|089|S|nausea/vomiting that doesn't stop, yellowing eyes/skin,||
4027|090|S|stomach/abdominal pain, dark urine), mental/mood changes (such as||
4027|091|S|severe depression, memory loss), breast lumps, swelling of||
4027|092|S|hands/feet, unusual vaginal bleeding (such as spotting,||
4027|093|S|breakthrough bleeding, prolonged/recurrent bleeding), unusual||
4027|094|S|vaginal discharge/itching/odor, changes in skin color, unusual||
4027|095|S|tiredness, worsening of seizures.||
4027|096|S|   Women may experience signs of masculinization (male||
4027|097|S|characteristics) from methyltestosterone. To prevent these||
4027|098|S|changes from becoming permanent, stop taking this medication and||
4027|099|S|tell your doctor right away if any of the following occur:||
4027|100|S|hoarseness, deepening of the voice, facial hair growth, new or||
4027|101|S|worsening acne, an enlarged clitoris, menstrual period changes.||
4027|102|S|   This medication may rarely cause serious (sometimes fatal)||
4027|103|S|problems from blood clots (such as heart attack, stroke, blood||
4027|104|S|clots in the lungs or legs). Get medical help right away if you||
4027|105|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
4027|106|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
4027|107|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
4027|108|S|trouble speaking, weakness on one side of the body, sudden vision||
4027|109|S|changes.||
4027|110|S|   A very serious allergic reaction to this drug is rare.||
4027|111|S|However, get medical help right away if you notice any symptoms||
4027|112|S|of a serious allergic reaction, including: rash, itching/swelling||
4027|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4027|114|S|breathing.||
4027|115|S|   This is not a complete list of possible side effects. If you||
4027|116|S|notice other effects not listed above, contact your doctor or||
4027|117|S|pharmacist.||
4027|118|S|   In the US -||
4027|119|S|   Call your doctor for medical advice about side effects. You||
4027|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4027|121|S|www.fda.gov/medwatch.||
4027|122|S|   In Canada - Call your doctor for medical advice about side||
4027|123|S|effects. You may report side effects to Health Canada at||
4027|124|S|1-866-234-2345.||
4027|125|B|||
4027|126|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
4027|127|P|pharmacist if you are allergic to methyltestosterone or estrogen;||
4027|128|P|or if you have any other allergies. This product may contain||
4027|129|P|inactive ingredients, which can cause allergic reactions or other||
4027|130|P|problems. Talk to your pharmacist for more details.||
4027|131|P|   Before using this medication, tell your doctor or pharmacist||
4027|132|P|your medical history, especially of: vaginal bleeding of unknown||
4027|133|P|cause, certain cancers (such as breast cancer, cancer of the||
4027|134|P|uterus or ovaries), blood clotting disorders (such as protein C||
4027|135|P|or protein S deficiency), current/history of blood clots (such as||
4027|136|P|in the legs, eyes, lungs), liver problems, family medical history||
4027|137|P|(especially breast lumps, cancer, blood clots), family or||
4027|138|P|personal history of a certain swelling disorder (angioedema),||
4027|139|P|asthma, diabetes, seizures, migraine headaches, heart disease||
4027|140|P|(such as high blood pressure, heart failure, heart attack),||
4027|141|P|stroke, kidney disease, underactive thyroid (hypothyroidism), a||
4027|142|P|certain hormone problem (hypoparathyroidism), mineral imbalance||
4027|143|P|(low or high calcium blood level), mental/mood disorders (such as||
4027|144|P|dementia, depression), high blood pressure during pregnancy||
4027|145|P|(toxemia), yellowing eyes/skin (cholestatic jaundice) during||
4027|146|P|pregnancy or with past estrogen use, uterus problems (such as||
4027|147|P|uterine fibroids, endometriosis), high blood cholesterol/fat||
4027|148|P|(triglyceride) levels, gallbladder disease, obesity, certain||
4027|149|P|blood disorder (porphyria), lupus.||
4027|150|P|   If you have diabetes, this medication may make it harder to||
4027|151|P|control your blood sugar levels. Monitor your blood sugar||
4027|152|P|regularly as directed by your doctor. Tell your doctor the||
4027|153|P|results and of any symptoms such as increased thirst/urination,||
4027|154|P|weakness, or fainting. Your anti-diabetic medication or diet may||
4027|155|P|need to be adjusted.||
4027|156|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4027|157|P|can make you more dizzy. Do not drive, use machinery, or do||
4027|158|P|anything that needs alertness until you can do it safely. Limit||
4027|159|P|alcoholic beverages. Talk to your doctor if you are using||
4027|160|P|marijuana (cannabis).||
4027|161|P|   If you are nearsighted or wear contact lenses, you may develop||
4027|162|P|vision problems or trouble wearing your contact lenses. Contact||
4027|163|P|your eye doctor if these problems occur.||
4027|164|P|   This medication may cause blotchy, dark areas on your face and||
4027|165|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
4027|166|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
4027|167|P|wear protective clothing when outdoors.||
4027|168|P|   Do not smoke cigarettes or use tobacco. Estrogens combined||
4027|169|P|with smoking further increase your risk for stroke, blood clots,||
4027|170|P|high blood pressure, and heart attacks, especially in women older||
4027|171|P|than 35.||
4027|172|P|   If you will be having surgery or will be confined to a chair||
4027|173|P|or bed for a long time (such as on a long plane flight), notify||
4027|174|P|your doctor beforehand. Special precautions may need to be taken||
4027|175|P|in these circumstances (such as stopping this medication) because||
4027|176|P|of the increased risk for blood clots. Consult your doctor for||
4027|177|P|details.||
4027|178|P|   This medication must not be used during pregnancy. It may harm||
4027|179|P|the unborn baby. If you become pregnant or think you may be||
4027|180|P|pregnant, tell your doctor right away.||
4027|181|P|   This medication is not effective for preventing a miscarriage||
4027|182|P|and should not be used for this purpose.||
4027|183|P|   It is unknown if methyltestosterone passes into breast milk.||
4027|184|P|Estrogen passes into breast milk. Because of the possible risk to||
4027|185|P|the infant, breastfeeding is not recommended while using this||
4027|186|P|medication. Consult your doctor before breastfeeding.||
4027|187|B|||
4027|188|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4027|189|I|medications work or increase your risk for serious side effects.||
4027|190|I|This document does not contain all possible drug interactions.||
4027|191|I|Keep a list of all the products you use (including||
4027|192|I|prescription/nonprescription drugs and herbal products) and share||
4027|193|I|it with your doctor and pharmacist. Do not start, stop, or change||
4027|194|I|the dosage of any medicines without your doctor's approval.||
4027|195|I|   Some products that may interact with this drug include:||
4027|196|I|anastrozole, "blood thinner" (warfarin), corticosteroids (such as||
4027|197|I|prednisone), exemestane, fezolinetant, ospemifene, raloxifene,||
4027|198|I|tamoxifen, tranexamic acid.||
4027|199|I|   Other medications can affect the removal of estrogens from||
4027|200|I|your body, which may affect how this medication works. Examples||
4027|201|I|include azole antifungals (such as itraconazole), macrolide||
4027|202|I|antibiotics (such as erythromycin), rifamycins (such as||
4027|203|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
4027|204|I|as carbamazepine, phenytoin), among others.||
4027|205|I|   This medication may interfere with certain lab tests, possibly||
4027|206|I|causing false test results. Make sure lab personnel and all your||
4027|207|I|doctors know you use this drug.||
4027|208|B|||
4027|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4027|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4027|211|O|poison control center right away. US residents can call||
4027|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4027|213|O|Symptoms of overdose may include: severe nausea/vomiting, unusual||
4027|214|O|vaginal bleeding.||
4027|215|B|||
4027|216|N|NOTES:  Do not share this medication with others. Regular||
4027|217|N|complete physical exams which include lab and/or medical tests||
4027|218|N|(such as blood pressure, breast exam/mammogram, pelvic exam, Pap||
4027|219|N|smear) should be done while you are taking this medication.||
4027|220|N|Follow your doctor's instructions for examining your breasts, and||
4027|221|N|report any lumps right away. Keep all medical and lab||
4027|222|N|appointments. Consult your doctor for more details.||
4027|223|N|   Lifestyle changes (such as reducing stress, eating a low||
4027|224|N|fat/low salt diet, losing weight if you are overweight) to||
4027|225|N|control or prevent high blood pressure, high cholesterol, and||
4027|226|N|diabetes help to prevent heart disease and strokes. Keep your||
4027|227|N|mind active with mental exercises to help prevent dementia.||
4027|228|N|Discuss with your doctor lifestyle changes that might benefit||
4027|229|N|you.||
4027|230|N|   You can also manage hot flashes by keeping a cool body||
4027|231|N|temperature (such as by using a fan, drinking cool beverages,||
4027|232|N|dressing lightly/in layers, avoiding hot/spicy foods). Limiting||
4027|233|N|caffeine and alcohol, exercising regularly, and learning||
4027|234|N|relaxation techniques may help reduce hot flashes. Vaginal||
4027|235|N|lubricants can help lessen discomfort during intercourse.||
4027|236|B|||
4027|237|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4027|238|D|remember. If it is near the time of the next dose, skip the||
4027|239|D|missed dose. Take your next dose at the regular time. Do not||
4027|240|D|double the dose to catch up.||
4027|241|B|||
4027|242|R|STORAGE:  Store at room temperature away from light and moisture.||
4027|243|R|Do not store in the bathroom. Keep all medications away from||
4027|244|R|children and pets.||
4027|245|R|   Do not flush medications down the toilet or pour them into a||
4027|246|R|drain unless instructed to do so. Properly discard this product||
4027|247|R|when it is expired or no longer needed. Consult your pharmacist||
4027|248|R|or local waste disposal company.||
4027|249|B|||
4027|250|A|Information last revised March 2025.||
4027|251|A|Copyright(c) 2025 First Databank, Inc.||
4027|252|B|||
4037|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4037|002|Z|does NOT have all possible information about this product. This||
4037|003|Z|information does not assure that this product is safe, effective,||
4037|004|Z|or appropriate for you. This information is not individual||
4037|005|Z|medical advice and does not substitute for the advice of your||
4037|006|Z|health care professional. Always ask your health care||
4037|007|Z|professional for complete information about this product and your||
4037|008|Z|specific health needs.||
4037|009|B|||
4037|010|T|GLYBURIDE - ORAL||
4037|011|F|(GLYE-bure-ide)||
4037|012|B|||
4037|013|C|COMMON BRAND NAME(S): Diabeta, Glycron, Glynase, Micronase||
4037|014|B|||
4037|015|U|USES:  Glyburide is used with a proper diet and exercise program||
4037|016|U|to control high blood sugar in people with type 2 diabetes. It||
4037|017|U|may also be used with other diabetes medications. Controlling||
4037|018|U|high blood sugar helps prevent kidney damage, blindness, nerve||
4037|019|U|problems, loss of limbs, and sexual function problems. Proper||
4037|020|U|control of diabetes may also lessen your risk of a heart attack||
4037|021|U|or stroke. Glyburide belongs to the class of drugs known as||
4037|022|U|sulfonylureas. It lowers blood sugar by causing the release of||
4037|023|U|your body's natural insulin.||
4037|024|B|||
4037|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4037|026|H|from your pharmacist before you start taking glyburide and each||
4037|027|H|time you get a refill. If you have any questions, ask your doctor||
4037|028|H|or pharmacist.||
4037|029|H|   Glyburide comes in different types of tablets which provide||
4037|030|H|different amounts of the medication. Do not switch between||
4037|031|H|different forms or brands of this medication unless directed by||
4037|032|H|your doctor.||
4037|033|H|   Take this medication by mouth with breakfast or the first main||
4037|034|H|meal of the day as directed by your doctor, usually once daily.||
4037|035|H|Some patients, especially those taking higher doses, may be||
4037|036|H|directed to take this drug twice a day. The dosage is based on||
4037|037|H|your medical condition and response to treatment.||
4037|038|H|   To reduce your risk of side effects, your doctor may direct||
4037|039|H|you to start this medication at a low dose and gradually increase||
4037|040|H|your dose. Follow your doctor's instructions carefully.||
4037|041|H|   If you are also taking colesevelam, take glyburide at least 4||
4037|042|H|hours before colesevelam.||
4037|043|H|   Use this medication regularly to get the most benefit from it.||
4037|044|H|To help you remember, use it at the same time(s) each day.||
4037|045|H|   Tell your doctor if your condition does not get better or if||
4037|046|H|it gets worse (your blood sugar is too high or too low).||
4037|047|B|||
4037|048|S|SIDE EFFECTS:  Nausea, heartburn, stomach fullness, and weight||
4037|049|S|gain may occur. If any of these effects last or get worse, tell||
4037|050|S|your doctor or pharmacist promptly.||
4037|051|S|   Remember that this medication has been prescribed because your||
4037|052|S|doctor has judged that the benefit to you is greater than the||
4037|053|S|risk of side effects. Many people using this medication do not||
4037|054|S|have serious side effects.||
4037|055|S|   Tell your doctor right away if you have any serious side||
4037|056|S|effects, including: signs of infection (such as sore throat that||
4037|057|S|doesn't go away, fever, chills), easy bleeding/bruising, stomach||
4037|058|S|pain, yellowing eyes/skin, dark urine, unusual||
4037|059|S|tiredness/weakness, unusual/sudden weight gain, mental/mood||
4037|060|S|changes, swelling of the hands or feet, seizures.||
4037|061|S|   This medication can cause low blood sugar (hypoglycemia). This||
4037|062|S|may occur if you do not get enough calories from food or if you||
4037|063|S|do unusually heavy exercise. Symptoms of low blood sugar include||
4037|064|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
4037|065|S|dizziness, or tingling hands/feet. It is a good habit to carry||
4037|066|S|glucose tablets or gel to treat low blood sugar. If you don't||
4037|067|S|have these reliable forms of glucose, rapidly raise your blood||
4037|068|S|sugar by eating a quick source of sugar such as table sugar,||
4037|069|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
4037|070|S|doctor right away about the reaction and the use of this product.||
4037|071|S|To help prevent low blood sugar, eat meals on a regular schedule,||
4037|072|S|and do not skip meals. Check with your doctor or pharmacist to||
4037|073|S|find out what you should do if you miss a meal.||
4037|074|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
4037|075|S|thirst/urination. If these symptoms occur, tell your doctor right||
4037|076|S|away. Your doctor may need to adjust your diabetes medication,||
4037|077|S|exercise program, or diet.||
4037|078|S|   A very serious allergic reaction to this drug is rare.||
4037|079|S|However, get medical help right away if you notice any symptoms||
4037|080|S|of a serious allergic reaction, including: rash, itching/swelling||
4037|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4037|082|S|breathing.||
4037|083|S|   This is not a complete list of possible side effects. If you||
4037|084|S|notice other effects not listed above, contact your doctor or||
4037|085|S|pharmacist.||
4037|086|S|   In the US -||
4037|087|S|   Call your doctor for medical advice about side effects. You||
4037|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4037|089|S|www.fda.gov/medwatch.||
4037|090|S|   In Canada - Call your doctor for medical advice about side||
4037|091|S|effects. You may report side effects to Health Canada at||
4037|092|S|1-866-234-2345.||
4037|093|B|||
4037|094|P|PRECAUTIONS:  Before taking glyburide, tell your doctor or||
4037|095|P|pharmacist if you are allergic to it or if you have any other||
4037|096|P|allergies. This product may contain inactive ingredients, which||
4037|097|P|can cause allergic reactions or other problems. Talk to your||
4037|098|P|pharmacist for more details.||
4037|099|P|   Before using this medication, tell your doctor or pharmacist||
4037|100|P|your medical history, especially of: liver disease, kidney||
4037|101|P|disease, thyroid disease, certain hormonal conditions||
4037|102|P|(adrenal/pituitary insufficiency, syndrome of inappropriate||
4037|103|P|antidiuretic hormone-SIADH), electrolyte imbalance||
4037|104|P|(hyponatremia), a certain nervous system problem (autonomic||
4037|105|P|neuropathy).||
4037|106|P|   You may experience blurred vision, dizziness, or drowsiness||
4037|107|P|due to extremely low or high blood sugar. Do not drive, use||
4037|108|P|machinery, or do anything that needs alertness or clear vision||
4037|109|P|until you can do it safely.||
4037|110|P|   Limit alcohol while taking this medication because it can||
4037|111|P|increase the risk of developing low blood sugar. Rarely, alcohol||
4037|112|P|can interact with glyburide and cause a serious reaction||
4037|113|P|(disulfiram-like reaction) with symptoms such as facial flushing,||
4037|114|P|nausea, vomiting, dizziness, or stomach pain. Consult your doctor||
4037|115|P|or pharmacist about the safe use of alcohol.||
4037|116|P|   It may be harder to control your blood sugar when your body is||
4037|117|P|stressed (such as due to fever, infection, injury, or surgery).||
4037|118|P|Consult your doctor because this may require a change in your||
4037|119|P|treatment plan, medications, or blood sugar testing.||
4037|120|P|   This medication may make you more sensitive to the sun. Limit||
4037|121|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4037|122|P|sunscreen and wear protective clothing when outdoors. Tell your||
4037|123|P|doctor right away if you get sunburned or have skin||
4037|124|P|blisters/redness.||
4037|125|P|   Before having surgery, tell your doctor or dentist about all||
4037|126|P|the products you use (including prescription drugs,||
4037|127|P|nonprescription drugs, and herbal products).||
4037|128|P|   Older adults may be more sensitive to the side effects of this||
4037|129|P|drug, especially low blood sugar.||
4037|130|P|   During pregnancy, this medication should be used only when||
4037|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
4037|132|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
4037|133|P|your doctor for managing your blood sugar while pregnant. Your||
4037|134|P|doctor may change your diabetes treatment during your pregnancy||
4037|135|P|(such as diet and medications including insulin).||
4037|136|P|   It is unknown if this medication passes into breast milk.||
4037|137|P|However, similar drugs pass into breast milk. Consult your doctor||
4037|138|P|before breastfeeding.||
4037|139|B|||
4037|140|I|DRUG INTERACTIONS:  See also How To Use section.||
4037|141|I|   Drug interactions may change how your medications work or||
4037|142|I|increase your risk for serious side effects. This document does||
4037|143|I|not contain all possible drug interactions. Keep a list of all||
4037|144|I|the products you use (including prescription/nonprescription||
4037|145|I|drugs and herbal products) and share it with your doctor and||
4037|146|I|pharmacist. Do not start, stop, or change the dosage of any||
4037|147|I|medicines without your doctor's approval.||
4037|148|I|   A product that may interact with this drug is: bosentan.||
4037|149|I|   Many drugs can affect your blood sugar, making it harder to||
4037|150|I|control. Before you start, stop, or change any medication, talk||
4037|151|I|with your doctor or pharmacist about how the medication may||
4037|152|I|affect your blood sugar. Check your blood sugar regularly as||
4037|153|I|directed and share the results with your doctor. Tell your doctor||
4037|154|I|right away if you have symptoms of high or low blood sugar. (See||
4037|155|I|also Side Effects section.) Your doctor may need to adjust your||
4037|156|I|diabetes medication, exercise program, or diet.||
4037|157|I|   Beta-blocker medications (including metoprolol, propranolol,||
4037|158|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
4037|159|I|heartbeat you would usually feel when your blood sugar falls too||
4037|160|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
4037|161|I|dizziness, hunger, or sweating are unaffected by these drugs.||
4037|162|B|||
4037|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4037|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4037|165|O|poison control center right away. US residents can call||
4037|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4037|167|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
4037|168|O|sweating, loss of consciousness.||
4037|169|B|||
4037|170|N|NOTES:  Do not share this medication with others.||
4037|171|N|   Attend a diabetes education program to learn more about how to||
4037|172|N|manage your diabetes with medications, diet, exercise, and||
4037|173|N|regular medical exams.||
4037|174|N|   Learn the symptoms of high and low blood sugar and how to||
4037|175|N|treat low blood sugar. Check your blood sugar regularly as||
4037|176|N|directed.||
4037|177|N|   Lab and/or medical tests (such as liver/kidney function,||
4037|178|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
4037|179|N|should be done while you are taking this medication. Keep all||
4037|180|N|medical and lab appointments. Consult your doctor for more||
4037|181|N|details.||
4037|182|B|||
4037|183|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
4037|184|D|you remember. If it is near the time of the next dose, skip the||
4037|185|D|missed dose. Take your next dose at the regular time. Do not||
4037|186|D|double the dose to catch up.||
4037|187|B|||
4037|188|R|STORAGE:  Store at room temperature away from light and moisture.||
4037|189|R|Do not store in the bathroom. Keep all medications away from||
4037|190|R|children and pets.||
4037|191|R|   Do not flush medications down the toilet or pour them into a||
4037|192|R|drain unless instructed to do so. Properly discard this product||
4037|193|R|when it is expired or no longer needed. Consult your pharmacist||
4037|194|R|or local waste disposal company.||
4037|195|B|||
4037|196|M|MEDICAL ALERT:  Your condition can cause complications in a||
4037|197|M|medical emergency. For information about enrolling in MedicAlert,||
4037|198|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4037|199|B|||
4037|200|A|Information last revised November 2025.||
4037|201|A|Copyright(c) 2025 First Databank, Inc.||
4037|202|B|||
4038|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4038|002|Z|does NOT have all possible information about this product. This||
4038|003|Z|information does not assure that this product is safe, effective,||
4038|004|Z|or appropriate for you. This information is not individual||
4038|005|Z|medical advice and does not substitute for the advice of your||
4038|006|Z|health care professional. Always ask your health care||
4038|007|Z|professional for complete information about this product and your||
4038|008|Z|specific health needs.||
4038|009|B|||
4038|010|T|IRON/VITAMIN C SUSTAINED-RELEASE - ORAL||
4038|011|F|(EYE-urn/Vitamin C)||
4038|012|B|||
4038|013|C|COMMON BRAND NAME(S): Fero-Grad, Folitab||
4038|014|B|||
4038|015|W|WARNING:  Accidental overdose of iron-containing products is a||
4038|016|W|leading cause of fatal poisoning in children under 6 years of||
4038|017|W|age. Keep this product out of reach of children. If overdose does||
4038|018|W|occur, get medical help right away or call a poison control||
4038|019|W|center.||
4038|020|B|||
4038|021|U|USES:  This medication is an iron supplement used to treat or||
4038|022|U|prevent low blood levels of iron (such as those caused by anemia||
4038|023|U|or during pregnancy). Ascorbic acid (vitamin C) improves the||
4038|024|U|absorption of iron from the stomach.||
4038|025|B|||
4038|026|H|HOW TO USE:  Take this medication by mouth, usually once daily or||
4038|027|H|as directed by your doctor.||
4038|028|H|   This medication is best taken on an empty stomach 1 hour||
4038|029|H|before or 2 hours after meals. If stomach upset occurs, you may||
4038|030|H|take this medication with food. Avoid taking antacids, dairy||
4038|031|H|products, tea, or coffee within 2 hours before or after this||
4038|032|H|medication because they will decrease its effectiveness.||
4038|033|H|   Swallow this medication with a full glass of water (8 ounces||
4038|034|H|or 240 milliliters) unless your doctor directs you otherwise.||
4038|035|H|Swallow the tablets whole. Do not crush or chew the tablets.||
4038|036|H|Doing so can release all of the drug at once, increasing the risk||
4038|037|H|of side effects. Do not lie down for at least 10 minutes after||
4038|038|H|taking this medication.||
4038|039|H|   Use this medication regularly in order to get the most benefit||
4038|040|H|from it. To help you remember, take it at the same time each day.||
4038|041|B|||
4038|042|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
4038|043|S|occur. These effects are usually temporary and may disappear as||
4038|044|S|your body adjusts to this medication. If any of these effects||
4038|045|S|last or get worse, tell your doctor or pharmacist promptly.||
4038|046|S|   Iron may cause your stools to turn black, which is not||
4038|047|S|harmful.||
4038|048|S|   If your doctor has prescribed this medication, remember that||
4038|049|S|your doctor has judged that the benefit to you is greater than||
4038|050|S|the risk of side effects. Many people using this medication do||
4038|051|S|not have serious side effects.||
4038|052|S|   A very serious allergic reaction to this drug is rare.||
4038|053|S|However, get medical help right away if you notice any symptoms||
4038|054|S|of a serious allergic reaction, including: rash, itching/swelling||
4038|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4038|056|S|breathing.||
4038|057|S|   This is not a complete list of possible side effects. If you||
4038|058|S|notice other effects not listed above, contact your doctor or||
4038|059|S|pharmacist.||
4038|060|S|   In the US -||
4038|061|S|   Call your doctor for medical advice about side effects. You||
4038|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4038|063|S|www.fda.gov/medwatch.||
4038|064|S|   In Canada - Call your doctor for medical advice about side||
4038|065|S|effects. You may report side effects to Health Canada at||
4038|066|S|1-866-234-2345.||
4038|067|B|||
4038|068|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
4038|069|P|pharmacist if you are allergic to it; or if you have any other||
4038|070|P|allergies. This product may contain inactive ingredients, which||
4038|071|P|can cause allergic reactions or other problems. Talk to your||
4038|072|P|pharmacist for more details.||
4038|073|P|   Before taking this medication, tell your doctor or pharmacist||
4038|074|P|your medical history, especially of: certain metabolic disorders||
4038|075|P|(such as hemochromatosis, hemosiderosis), use/abuse of alcohol,||
4038|076|P|stomach/intestinal problems (such as ulcers, colitis).||
4038|077|P|   If your particular brand of iron supplement also contains||
4038|078|P|folic acid, be sure to tell your doctor or pharmacist if you have||
4038|079|P|vitamin B12 deficiency (pernicious anemia) before taking it.||
4038|080|P|   Before having surgery, tell your doctor or dentist about all||
4038|081|P|the products you use (including prescription drugs,||
4038|082|P|nonprescription drugs, and herbal products).||
4038|083|P|   During pregnancy, this medication should be used only when||
4038|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
4038|085|P|   This medication passes into breast milk. Consult your doctor||
4038|086|P|before breastfeeding.||
4038|087|B|||
4038|088|I|DRUG INTERACTIONS:  See also How To Use section.||
4038|089|I|   Drug interactions may change how your medications work or||
4038|090|I|increase your risk for serious side effects. This document does||
4038|091|I|not contain all possible drug interactions. Keep a list of all||
4038|092|I|the products you use (including prescription/nonprescription||
4038|093|I|drugs and herbal products) and share it with your doctor and||
4038|094|I|pharmacist. Do not start, stop, or change the dosage of any||
4038|095|I|medicines without your doctor's approval.||
4038|096|I|   This product can decrease the absorption of certain drugs,||
4038|097|I|especially if you take them around the same time. These drugs||
4038|098|I|include bisphosphonates (such as alendronate), levodopa,||
4038|099|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
4038|100|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
4038|101|I|minocycline), thyroid medications (such as levothyroxine), among||
4038|102|I|others. Ask your doctor or pharmacist how long you should wait||
4038|103|I|between doses of this product and your other medications and to||
4038|104|I|find a dosing schedule that works for all your medications.||
4038|105|I|   This medication may interfere with certain lab tests (such as||
4038|106|I|tests for blood in the stools), possibly causing false test||
4038|107|I|results. Make sure lab personnel and all your doctors know you||
4038|108|I|use this drug.||
4038|109|B|||
4038|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4038|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4038|112|O|poison control center right away. US residents can call||
4038|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4038|114|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
4038|115|O|diarrhea.||
4038|116|B|||
4038|117|N|NOTES:  Do not share this medication with others.||
4038|118|N|   Lab and/or medical tests (such as complete blood count) may be||
4038|119|N|done while you are taking this product. Keep all medical and lab||
4038|120|N|appointments. Consult your doctor for more details.||
4038|121|N|   There are many iron supplement products available. Some can be||
4038|122|N|purchased without a prescription. Consult your doctor or||
4038|123|N|pharmacist for more details.||
4038|124|N|   This medication is not a substitute for a proper diet. It is||
4038|125|N|important to maintain a well-balanced diet. Foods rich in iron||
4038|126|N|include beans, nuts, asparagus, oatmeal, red meat, dried peaches,||
4038|127|N|and pork liver.||
4038|128|B|||
4038|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4038|130|D|remember. If it is near the time of the next dose, skip the||
4038|131|D|missed dose. Take your next dose at the regular time. Do not||
4038|132|D|double the dose to catch up.||
4038|133|B|||
4038|134|R|STORAGE:  Store at room temperature away from light and moisture.||
4038|135|R|Do not store in the bathroom. Keep all medications away from||
4038|136|R|children and pets.||
4038|137|R|   Do not flush medications down the toilet or pour them into a||
4038|138|R|drain unless instructed to do so. Properly discard this product||
4038|139|R|when it is expired or no longer needed. Consult your pharmacist||
4038|140|R|or local waste disposal company.||
4038|141|B|||
4038|142|A|Information last revised October 2025.||
4038|143|A|Copyright(c) 2025 First Databank, Inc.||
4038|144|B|||
4041|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4041|002|Z|does NOT have all possible information about this product. This||
4041|003|Z|information does not assure that this product is safe, effective,||
4041|004|Z|or appropriate for you. This information is not individual||
4041|005|Z|medical advice and does not substitute for the advice of your||
4041|006|Z|health care professional. Always ask your health care||
4041|007|Z|professional for complete information about this product and your||
4041|008|Z|specific health needs.||
4041|009|B|||
4041|010|T|ROPINIROLE - ORAL||
4041|011|F|(row-PIN-uh-roll)||
4041|012|B|||
4041|013|C|COMMON BRAND NAME(S): Requip||
4041|014|B|||
4041|015|U|USES:  This medication is used alone or with other medications to||
4041|016|U|treat Parkinson's disease. It can improve your ability to move||
4041|017|U|and decrease shakiness (tremor), stiffness, slowed movement, and||
4041|018|U|unsteadiness. It may also decrease the number of episodes of not||
4041|019|U|being able to move ("on-off syndrome").||
4041|020|U|   Ropinirole is also used to treat restless legs syndrome (RLS).||
4041|021|U|It may improve your sleep by decreasing the urge to move your||
4041|022|U|legs and decreasing uncomfortable/unpleasant feelings in the||
4041|023|U|legs.||
4041|024|U|   This medication works by helping to restore the balance of a||
4041|025|U|certain natural substance (dopamine) in the brain.||
4041|026|B|||
4041|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4041|028|H|from your pharmacist before you start taking ropinirole and each||
4041|029|H|time you get a refill. If you have any questions, ask your doctor||
4041|030|H|or pharmacist.||
4041|031|H|   If you are taking this medication for Parkinson's disease,||
4041|032|H|take this medication by mouth with or without food as directed by||
4041|033|H|your doctor, usually 3 times a day. Taking this medication with||
4041|034|H|food may reduce nausea. To reduce your risk of side effects (such||
4041|035|H|as drowsiness, low blood pressure), your doctor may direct you to||
4041|036|H|start this medication at a low dose and gradually increase your||
4041|037|H|dose. Follow your doctor's instructions carefully.||
4041|038|H|   If you are using this medication for RLS, take this medication||
4041|039|H|by mouth with or without food as directed by your doctor, usually||
4041|040|H|once daily (1 to 3 hours before bedtime).||
4041|041|H|   Use this medication regularly to get the most benefit from it.||
4041|042|H|To help you remember, use it at the same time(s) each day. Take||
4041|043|H|this medication as prescribed. Do not increase your dose or take||
4041|044|H|it more often than directed.||
4041|045|H|   If you stop taking this medication for several days, you may||
4041|046|H|need to increase your dose slowly back to your previous dosage.||
4041|047|H|Talk with your doctor about how to restart the medication.||
4041|048|H|   Do not stop taking this medication without consulting your||
4041|049|H|doctor. Some conditions may become worse when this medication is||
4041|050|H|suddenly stopped. Also, if you suddenly stop using this||
4041|051|H|medication, you may have withdrawal symptoms (such as anxiety,||
4041|052|H|depression, confusion, fever, muscle stiffness). To help prevent||
4041|053|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
4041|054|H|more likely if you have used ropinirole for a long time or in||
4041|055|H|high doses. Tell your doctor or pharmacist right away if you have||
4041|056|H|withdrawal.||
4041|057|H|   If you are taking this medication for RLS, tell your doctor if||
4041|058|H|your symptoms increase or get worse in the early morning, or if||
4041|059|H|you start getting symptoms earlier in the evening or late||
4041|060|H|afternoon. Your doctor may need to change your treatment.||
4041|061|H|   The dosage is based on your medical condition and response to||
4041|062|H|treatment. It may take a few weeks for this medication to take||
4041|063|H|effect. Tell your doctor if your condition does not get better or||
4041|064|H|if it gets worse.||
4041|065|B|||
4041|066|S|SIDE EFFECTS:  Nausea, vomiting, constipation, dizziness,||
4041|067|S|drowsiness, weakness, unusual sweating, headache, and dry mouth||
4041|068|S|may occur. If these effects last or get worse, tell your doctor||
4041|069|S|promptly.||
4041|070|S|   Remember that this medication has been prescribed because your||
4041|071|S|doctor has judged that the benefit to you is greater than the||
4041|072|S|risk of side effects. Many people using this medication do not||
4041|073|S|have serious side effects.||
4041|074|S|   You may also develop a sudden drop in blood pressure, which||
4041|075|S|can cause dizziness, nausea, and fainting. This is more likely||
4041|076|S|when you are first starting the medication or when your dose is||
4041|077|S|increased, or when you get up suddenly. To lower your risk, get||
4041|078|S|up slowly from a sitting or lying position.||
4041|079|S|   This medication may also raise your blood pressure. Check your||
4041|080|S|blood pressure regularly and tell your doctor if the results are||
4041|081|S|high.||
4041|082|S|   Tell your doctor right away if you have any serious side||
4041|083|S|effects, including: difficulty moving or walking, mental/mood||
4041|084|S|changes (such as confusion, agitation, hallucinations), muscle||
4041|085|S|cramps/spasms, decreased sexual ability, unusual strong urges||
4041|086|S|(such as increased gambling, increased sexual urges), swelling of||
4041|087|S|the ankles/feet, chest pain, unusually fast/slow/irregular||
4041|088|S|heartbeat, vision changes.||
4041|089|S|   Some people taking ropinirole have fallen asleep suddenly||
4041|090|S|during their usual daily activities (such as talking on the||
4041|091|S|phone, driving). In some cases, sleep occurred without any||
4041|092|S|feelings of drowsiness beforehand. This sleep effect may occur||
4041|093|S|anytime during treatment with ropinirole even if you have used||
4041|094|S|this medication for a long time. If you experience increased||
4041|095|S|sleepiness or fall asleep during the day, do not drive or take||
4041|096|S|part in other possibly dangerous activities until you have||
4041|097|S|discussed this effect with your doctor. Your risk of this sleep||
4041|098|S|effect is increased by using alcohol or other medications that||
4041|099|S|can make you drowsy. See also Precautions section.||
4041|100|S|   A very serious allergic reaction to this drug is rare.||
4041|101|S|However, get medical help right away if you notice any symptoms||
4041|102|S|of a serious allergic reaction, including: rash, itching/swelling||
4041|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4041|104|S|breathing.||
4041|105|S|   This is not a complete list of possible side effects. If you||
4041|106|S|notice other effects not listed above, contact your doctor or||
4041|107|S|pharmacist.||
4041|108|S|   In the US -||
4041|109|S|   Call your doctor for medical advice about side effects. You||
4041|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4041|111|S|www.fda.gov/medwatch.||
4041|112|S|   In Canada - Call your doctor for medical advice about side||
4041|113|S|effects. You may report side effects to Health Canada at||
4041|114|S|1-866-234-2345.||
4041|115|B|||
4041|116|P|PRECAUTIONS:  Before taking ropinirole, tell your doctor or||
4041|117|P|pharmacist if you are allergic to it; or if you have any other||
4041|118|P|allergies. This product may contain inactive ingredients, which||
4041|119|P|can cause allergic reactions or other problems. Talk to your||
4041|120|P|pharmacist for more details.||
4041|121|P|   Before using this medication, tell your doctor or pharmacist||
4041|122|P|your medical history, especially of: heart problems (including||
4041|123|P|irregular heartbeat), mental/mood disorders (such as confusion,||
4041|124|P|hallucinations, psychoses, schizophrenia), difficulty walking,||
4041|125|P|kidney problems, liver problems, high or low blood pressure,||
4041|126|P|sleep disorder (such as sleep apnea, narcolepsy).||
4041|127|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4041|128|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4041|129|P|machinery, or do anything that needs alertness until you can do||
4041|130|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
4041|131|P|are using marijuana (cannabis). See also Side Effects section.||
4041|132|P|   Before having surgery, tell your doctor or dentist about all||
4041|133|P|the products you use (including prescription drugs,||
4041|134|P|nonprescription drugs, and herbal products).||
4041|135|P|   Older adults may be more sensitive to the side effects of this||
4041|136|P|drug, especially mental/mood changes (such as hallucinations),||
4041|137|P|nausea, and vomiting.||
4041|138|P|   During pregnancy, this medication should be used only when||
4041|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
4041|140|P|   It is unknown if this medication passes into breast milk.||
4041|141|P|Consult your doctor before breastfeeding.||
4041|142|B|||
4041|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4041|144|I|medications work or increase your risk for serious side effects.||
4041|145|I|This document does not contain all possible drug interactions.||
4041|146|I|Keep a list of all the products you use (including||
4041|147|I|prescription/nonprescription drugs and herbal products) and share||
4041|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
4041|149|I|the dosage of any medicines without your doctor's approval.||
4041|150|I|   A product that may interact with this drug is: metoclopramide.||
4041|151|I|   Other medications can affect the removal of ropinirole from||
4041|152|I|your body, which may affect how ropinirole works. Examples||
4041|153|I|include cimetidine, fluvoxamine, mexiletine, omeprazole, among||
4041|154|I|others.||
4041|155|I|   Tell your doctor or pharmacist if you are taking other||
4041|156|I|products that cause drowsiness such as opioid pain or cough||
4041|157|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4041|158|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4041|159|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4041|160|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
4041|161|I|diphenhydramine).||
4041|162|I|   Check the labels on all your medicines (such as allergy or||
4041|163|I|cough-and-cold products) because they may contain ingredients||
4041|164|I|that cause drowsiness. Ask your pharmacist about using those||
4041|165|I|products safely.||
4041|166|I|   Cigarette smoking decreases the level of this medication in||
4041|167|I|your bloodstream. Tell your doctor if you smoke or if you have||
4041|168|I|recently stopped smoking.||
4041|169|B|||
4041|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4041|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4041|172|O|poison control center right away. US residents can call||
4041|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4041|174|B|||
4041|175|N|NOTES:  Do not share this medication with others.||
4041|176|B|||
4041|177|D|MISSED DOSE:  If you are taking this for Parkinson's and you miss||
4041|178|D|a dose, take it as soon as you remember. If it is almost time for||
4041|179|D|the next dose, skip the missed dose. Take your next dose at the||
4041|180|D|regular time. Do not double the dose to catch up.||
4041|181|D|   If you are taking this for RLS and you miss a dose, skip the||
4041|182|D|missed dose. Take your next dose at the regular time. Do not||
4041|183|D|double the dose to catch up.||
4041|184|B|||
4041|185|R|STORAGE:  Store at room temperature away from light and moisture.||
4041|186|R|Do not store in the bathroom. Keep all medications away from||
4041|187|R|children and pets.||
4041|188|R|   Do not flush medications down the toilet or pour them into a||
4041|189|R|drain unless instructed to do so. Properly discard this product||
4041|190|R|when it is expired or no longer needed. Consult your pharmacist||
4041|191|R|or local waste disposal company.||
4041|192|B|||
4041|193|A|Information last revised May 2024.||
4041|194|A|Copyright(c) 2025 First Databank, Inc.||
4041|195|B|||
4043|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4043|002|Z|does NOT have all possible information about this product. This||
4043|003|Z|information does not assure that this product is safe, effective,||
4043|004|Z|or appropriate for you. This information is not individual||
4043|005|Z|medical advice and does not substitute for the advice of your||
4043|006|Z|health care professional. Always ask your health care||
4043|007|Z|professional for complete information about this product and your||
4043|008|Z|specific health needs.||
4043|009|B|||
4043|010|T|BUMETANIDE - ORAL||
4043|011|F|(bue-MET-a-nide)||
4043|012|B|||
4043|013|C|COMMON BRAND NAME(S): Bumex||
4043|014|B|||
4043|015|W|WARNING:  Bumetanide is a very strong medication. Using too much||
4043|016|W|of this drug can lead to dehydration and electrolyte imbalance.||
4043|017|W|It is important that you are closely monitored by your doctor||
4043|018|W|while using this medication. Tell your doctor right away if you||
4043|019|W|have any symptoms of dehydration or electrolyte imbalance,||
4043|020|W|including unusual dry mouth/thirst, muscle cramps/weakness,||
4043|021|W|slow/fast/irregular heartbeat, or confusion.||
4043|022|B|||
4043|023|U|USES:  Bumetanide is used to reduce extra fluid in the body||
4043|024|U|(edema) caused by conditions such as heart failure, liver||
4043|025|U|disease, and kidney disease. Getting rid of extra water helps to||
4043|026|U|reduce fluid in the lungs so that you can breathe easier. It also||
4043|027|U|helps to decrease swelling of the arms, legs, and||
4043|028|U|stomach/abdomen. Bumetanide is a "water pill" (diuretic). It||
4043|029|U|causes your body to get rid of extra water by increasing the||
4043|030|U|amount of urine you make.||
4043|031|B|||
4043|032|V|OTHER USES:  This section contains uses of this drug that are not||
4043|033|V|listed in the approved professional labeling for the drug but||
4043|034|V|that may be prescribed by your health care professional. Use this||
4043|035|V|drug for a condition that is listed in this section only if it||
4043|036|V|has been so prescribed by your health care professional.||
4043|037|V|   This medication may also be used for high blood pressure.||
4043|038|B|||
4043|039|H|HOW TO USE:  Take this medication by mouth as directed by your||
4043|040|H|doctor, usually once or twice daily. If you take this drug too||
4043|041|H|close to bedtime, you may need to wake up to urinate. It is best||
4043|042|H|to take this medication at least 4 hours before your bedtime.||
4043|043|H|   The dosage is based on your medical condition and response to||
4043|044|H|treatment.||
4043|045|H|   Take this medication regularly to get the most benefit from||
4043|046|H|it. To help you remember, take it at the same time(s) of the day||
4043|047|H|as directed. Do not increase your dose or use this drug more||
4043|048|H|often or for longer than prescribed. Your condition will not||
4043|049|H|improve any faster, and your risk of side effects will increase.||
4043|050|H|   Tell your doctor if your condition does not get better or if||
4043|051|H|it gets worse.||
4043|052|B|||
4043|053|S|SIDE EFFECTS:  See also Warning section.||
4043|054|S|   Dizziness or lightheadedness may occur as your body adjusts to||
4043|055|S|the medication. If either of these effects lasts or gets worse,||
4043|056|S|tell your doctor or pharmacist promptly.||
4043|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
4043|058|S|slowly when rising from a sitting or lying position.||
4043|059|S|   Remember that this medication has been prescribed because your||
4043|060|S|doctor has judged that the benefit to you is greater than the||
4043|061|S|risk of side effects. Many people using this medication do not||
4043|062|S|have serious side effects.||
4043|063|S|   Tell your doctor right away if you have any serious side||
4043|064|S|effects, including: numbness/tingling/pain/redness/swelling of||
4043|065|S|the arms/legs, fainting, hearing changes (such as ringing in the||
4043|066|S|ears, decreased hearing), easy bruising/bleeding, signs of kidney||
4043|067|S|problems (such as change in the amount of urine).||
4043|068|S|   A very serious allergic reaction to this drug is rare.||
4043|069|S|However, get medical help right away if you notice any symptoms||
4043|070|S|of a serious allergic reaction, including: rash, itching/swelling||
4043|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4043|072|S|breathing.||
4043|073|S|   This is not a complete list of possible side effects. If you||
4043|074|S|notice other effects not listed above, contact your doctor or||
4043|075|S|pharmacist.||
4043|076|S|   In the US -||
4043|077|S|   Call your doctor for medical advice about side effects. You||
4043|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4043|079|S|www.fda.gov/medwatch.||
4043|080|S|   In Canada - Call your doctor for medical advice about side||
4043|081|S|effects. You may report side effects to Health Canada at||
4043|082|S|1-866-234-2345.||
4043|083|B|||
4043|084|P|PRECAUTIONS:  Before taking bumetanide, tell your doctor or||
4043|085|P|pharmacist if you are allergic to it; or if you have any other||
4043|086|P|allergies. This product may contain inactive ingredients, which||
4043|087|P|can cause allergic reactions or other problems. Talk to your||
4043|088|P|pharmacist for more details.||
4043|089|P|   Before using this medication, tell your doctor or pharmacist||
4043|090|P|your medical history, especially of: kidney problems (such as||
4043|091|P|inability to make urine), liver problems, gout.||
4043|092|P|   If you have diabetes, bumetanide may affect your blood sugar.||
4043|093|P|Check your blood sugar regularly as directed and share the||
4043|094|P|results with your doctor. Your doctor may need to adjust your||
4043|095|P|diabetes medication or diet.||
4043|096|P|   This drug may reduce the potassium levels in your blood. Ask||
4043|097|P|your doctor about adding potassium to your diet. A potassium||
4043|098|P|supplement may be prescribed by your doctor.||
4043|099|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4043|100|P|can make you more dizzy. Do not drive, use machinery, or do||
4043|101|P|anything that needs alertness until you can do it safely. Limit||
4043|102|P|alcoholic beverages. Talk to your doctor if you are using||
4043|103|P|marijuana (cannabis).||
4043|104|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
4043|105|P|and cause you to feel lightheaded. Tell your doctor if you have||
4043|106|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
4043|107|P|of fluids unless your doctor tells you not to.||
4043|108|P|   Before having surgery, tell your doctor or dentist about all||
4043|109|P|the products you use (including prescription drugs,||
4043|110|P|nonprescription drugs, and herbal products).||
4043|111|P|   Older adults may be more sensitive to the effects of this||
4043|112|P|drug, especially dizziness and water/mineral loss.||
4043|113|P|   During pregnancy, this drug should be used only when clearly||
4043|114|P|needed. Discuss the risks and benefits with your doctor.||
4043|115|P|   It is unknown if this drug passes into breast milk. Consult||
4043|116|P|your doctor before breastfeeding.||
4043|117|B|||
4043|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4043|119|I|medications work or increase your risk for serious side effects.||
4043|120|I|This document does not contain all possible drug interactions.||
4043|121|I|Keep a list of all the products you use (including||
4043|122|I|prescription/nonprescription drugs and herbal products) and share||
4043|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
4043|124|I|the dosage of any medicines without your doctor's approval.||
4043|125|I|   Some products that may interact with this drug are:||
4043|126|I|desmopressin, lithium, probenecid.||
4043|127|I|   Some products have ingredients that could raise your blood||
4043|128|I|pressure or worsen your swelling. Tell your pharmacist what||
4043|129|I|products you are using, and ask how to use them safely||
4043|130|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
4043|131|I|ibuprofen/naproxen).||
4043|132|B|||
4043|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4043|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4043|135|O|poison control center right away. US residents can call||
4043|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4043|137|O|Symptoms of overdose may include: fainting, severe weakness, a||
4043|138|O|severe decrease in the amount of urine.||
4043|139|B|||
4043|140|N|NOTES:  Do not share this medication with others.||
4043|141|N|   Lifestyle changes that may help this medication work better||
4043|142|N|include exercising, stopping smoking, and eating a||
4043|143|N|low-cholesterol/low-fat diet. Consult your doctor for more||
4043|144|N|details.||
4043|145|N|   Lab and/or medical tests (such as kidney function, blood||
4043|146|N|mineral levels such as potassium) should be done while you are||
4043|147|N|taking this medication. Keep all medical and lab appointments.||
4043|148|N|Consult your doctor for more details.||
4043|149|N|   Check your blood pressure and pulse (heart rate) regularly||
4043|150|N|while using this medication. Learn how to check your own blood||
4043|151|N|pressure and pulse at home, and share the results with your||
4043|152|N|doctor.||
4043|153|B|||
4043|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4043|155|D|remember. If it is near the time of the next dose, skip the||
4043|156|D|missed dose. Take your next dose at the regular time. Do not||
4043|157|D|double the dose to catch up.||
4043|158|B|||
4043|159|R|STORAGE:  Store at room temperature away from light and moisture.||
4043|160|R|Do not store in the bathroom. Keep all medications away from||
4043|161|R|children and pets.||
4043|162|R|   Do not flush medications down the toilet or pour them into a||
4043|163|R|drain unless instructed to do so. Properly discard this product||
4043|164|R|when it is expired or no longer needed. Consult your pharmacist||
4043|165|R|or local waste disposal company.||
4043|166|B|||
4043|167|A|Information last revised October 2025.||
4043|168|A|Copyright(c) 2025 First Databank, Inc.||
4043|169|B|||
4047|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4047|002|Z|does NOT have all possible information about this product. This||
4047|003|Z|information does not assure that this product is safe, effective,||
4047|004|Z|or appropriate for you. This information is not individual||
4047|005|Z|medical advice and does not substitute for the advice of your||
4047|006|Z|health care professional. Always ask your health care||
4047|007|Z|professional for complete information about this product and your||
4047|008|Z|specific health needs.||
4047|009|B|||
4047|010|T|MIRTAZAPINE - ORAL||
4047|011|F|(mer-TAZE-uh-peen)||
4047|012|B|||
4047|013|C|COMMON BRAND NAME(S): Remeron||
4047|014|B|||
4047|015|W|WARNING:  Antidepressant medications are used to treat a variety||
4047|016|W|of conditions, including depression and other mental/mood||
4047|017|W|disorders. These medications can help prevent suicidal||
4047|018|W|thoughts/attempts and provide other important benefits. However,||
4047|019|W|studies have shown that a small number of people (especially||
4047|020|W|people younger than 25) who take antidepressants for any||
4047|021|W|condition may experience worsening depression, other mental/mood||
4047|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
4047|023|W|talk with the doctor about the risks and benefits of||
4047|024|W|antidepressant medication (especially for people younger than||
4047|025|W|25), even if treatment is not for a mental/mood condition.||
4047|026|W|   Tell the doctor right away if you notice worsening||
4047|027|W|depression/other psychiatric conditions, unusual behavior changes||
4047|028|W|(including possible suicidal thoughts/attempts), or other||
4047|029|W|mental/mood changes (including new/worsening anxiety, panic||
4047|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
4047|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
4047|032|W|especially watchful for these symptoms when a new antidepressant||
4047|033|W|is started or when the dose is changed.||
4047|034|B|||
4047|035|U|USES:  This medication is used to treat depression. Mirtazapine||
4047|036|U|works by helping to restore the balance of certain natural||
4047|037|U|substances in the brain.||
4047|038|B|||
4047|039|H|HOW TO USE:  Read the Medication Guide provided by your||
4047|040|H|pharmacist before you start using mirtazapine and each time you||
4047|041|H|get a refill. If you have any questions, ask your doctor or||
4047|042|H|pharmacist.||
4047|043|H|   Take this medication by mouth with or without food as directed||
4047|044|H|by your doctor, usually once daily at bedtime. The dosage is||
4047|045|H|based on your medical condition and response to treatment.||
4047|046|H|   Use this medication regularly in order to get the most benefit||
4047|047|H|from it. To help you remember, take it at the same time each day.||
4047|048|H|It may take 1 to 4 weeks to notice improvement in your symptoms.||
4047|049|H|Do not increase your dose or take it more often than prescribed.||
4047|050|H|   Keep taking this medication even if you feel well. Do not stop||
4047|051|H|taking this medication without consulting your doctor. Some||
4047|052|H|conditions may become worse when you suddenly stop this drug.||
4047|053|H|Your dose may need to be gradually decreased.||
4047|054|H|   Tell your doctor if your condition does not get better or if||
4047|055|H|it gets worse.||
4047|056|B|||
4047|057|S|SIDE EFFECTS:  See also the Warning section.||
4047|058|S|   Dizziness, drowsiness, lightheadedness, increased appetite,||
4047|059|S|weight gain, dry mouth, or constipation may occur. If any of||
4047|060|S|these effects last or get worse, tell your doctor or pharmacist||
4047|061|S|promptly.||
4047|062|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
4047|063|S|chips, chew (sugarless) gum, drink water or use a saliva||
4047|064|S|substitute.||
4047|065|S|   To reduce the risk of dizziness and lightheadedness, get up||
4047|066|S|slowly when rising from a sitting or lying position.||
4047|067|S|   Remember that this medication has been prescribed because your||
4047|068|S|doctor has judged that the benefit to you is greater than the||
4047|069|S|risk of side effects. Many people using this medication do not||
4047|070|S|have serious side effects.||
4047|071|S|   Tell your doctor right away if you have any serious side||
4047|072|S|effects, including: swelling of the hands/feet, shaking (tremor),||
4047|073|S|confusion.||
4047|074|S|   Get medical help right away if you have any very serious side||
4047|075|S|effects, including: fast/irregular heartbeat, severe dizziness,||
4047|076|S|fainting, eye pain/swelling/redness, widened pupils, vision||
4047|077|S|changes (such as seeing rainbows around lights at night, blurred||
4047|078|S|vision).||
4047|079|S|   This medication may increase serotonin and rarely cause a very||
4047|080|S|serious condition called serotonin syndrome/toxicity. The risk||
4047|081|S|increases if you are also taking other drugs that increase||
4047|082|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
4047|083|S|take (see Drug Interactions section). Get medical help right away||
4047|084|S|if you develop some of the following symptoms: fast heartbeat,||
4047|085|S|hallucinations, loss of coordination, severe dizziness, severe||
4047|086|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
4047|087|S|unusual agitation/restlessness.||
4047|088|S|   A very serious allergic reaction to this drug is rare.||
4047|089|S|However, get medical help right away if you notice any symptoms||
4047|090|S|of a serious allergic reaction, including: fever, swollen lymph||
4047|091|S|nodes, rash, itching/swelling (especially of the||
4047|092|S|face/tongue/throat), severe dizziness, trouble breathing.||
4047|093|S|   This is not a complete list of possible side effects. If you||
4047|094|S|notice other effects not listed above, contact your doctor or||
4047|095|S|pharmacist.||
4047|096|S|   In the US -||
4047|097|S|   Call your doctor for medical advice about side effects. You||
4047|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4047|099|S|www.fda.gov/medwatch.||
4047|100|S|   In Canada - Call your doctor for medical advice about side||
4047|101|S|effects. You may report side effects to Health Canada at||
4047|102|S|1-866-234-2345.||
4047|103|B|||
4047|104|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
4047|105|P|pharmacist if you are allergic to it, or if you have any other||
4047|106|P|allergies. This product may contain inactive ingredients, which||
4047|107|P|can cause allergic reactions or other problems. Talk to your||
4047|108|P|pharmacist for more details.||
4047|109|P|   Before using this medication, tell your doctor or pharmacist||
4047|110|P|your medical history, especially of: history or family history of||
4047|111|P|psychiatric disorders (such as bipolar/manic-depressive||
4047|112|P|disorder), history or family history of suicide attempts, liver||
4047|113|P|disease, kidney disease, seizures, high blood cholesterol or||
4047|114|P|triglyceride levels, heart disease (such as recent heart attack,||
4047|115|P|angina), stroke, severe loss of body fluids (dehydration), low||
4047|116|P|blood pressure, personal or family history of glaucoma||
4047|117|P|(angle-closure type).||
4047|118|P|   Mirtazapine may cause a condition that affects the heart||
4047|119|P|rhythm (QT prolongation). QT prolongation can rarely cause||
4047|120|P|serious (rarely fatal) fast/irregular heartbeat and other||
4047|121|P|symptoms (such as severe dizziness, fainting) that need medical||
4047|122|P|attention right away.||
4047|123|P|   The risk of QT prolongation may be increased if you have||
4047|124|P|certain medical conditions or are taking other drugs that may||
4047|125|P|cause QT prolongation. Before using mirtazapine, tell your doctor||
4047|126|P|or pharmacist of all the drugs you take and if you have any of||
4047|127|P|the following conditions: certain heart problems (heart failure,||
4047|128|P|slow heartbeat, QT prolongation in the EKG), family history of||
4047|129|P|certain heart problems (QT prolongation in the EKG, sudden||
4047|130|P|cardiac death).||
4047|131|P|   Low levels of potassium or magnesium in the blood may also||
4047|132|P|increase your risk of QT prolongation. This risk may increase if||
4047|133|P|you use certain drugs (such as diuretics/"water pills") or if you||
4047|134|P|have conditions such as severe sweating, diarrhea, or vomiting.||
4047|135|P|Talk to your doctor about using mirtazapine safely.||
4047|136|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4047|137|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4047|138|P|machinery, or do anything that needs alertness until you can do||
4047|139|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
4047|140|P|are using marijuana (cannabis).||
4047|141|P|   Older adults may be more sensitive to the side effects of this||
4047|142|P|drug, especially drowsiness and QT prolongation (see above).||
4047|143|P|   During pregnancy, this medication should be used only when||
4047|144|P|clearly needed. If this medication is used during the last 3||
4047|145|P|months of pregnancy, rarely your newborn may develop symptoms||
4047|146|P|including feeding or breathing difficulties, seizures, muscle||
4047|147|P|stiffness, jitteriness or constant crying. Report any such||
4047|148|P|symptoms to your doctor promptly. However, since untreated||
4047|149|P|mental/mood disorders (such as depression) can be a serious||
4047|150|P|condition, do not stop taking this medication unless your doctor||
4047|151|P|directs you to do so. If you are planning pregnancy, become||
4047|152|P|pregnant, or think you may be pregnant, discuss with your doctor||
4047|153|P|right away the benefits and risks of using this medication during||
4047|154|P|pregnancy.||
4047|155|P|   This drug passes into breast milk. Consult your doctor before||
4047|156|P|breastfeeding.||
4047|157|B|||
4047|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4047|159|I|medications work or increase your risk for serious side effects.||
4047|160|I|This document does not contain all possible drug interactions.||
4047|161|I|Keep a list of all the products you use (including||
4047|162|I|prescription/nonprescription drugs and herbal products) and share||
4047|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
4047|164|I|the dosage of any medicines without your doctor's approval.||
4047|165|I|   Taking MAO inhibitors with this medication may cause a serious||
4047|166|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
4047|167|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
4047|168|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
4047|169|I|selegiline, tranylcypromine) during treatment with this||
4047|170|I|medication. Most MAO inhibitors should also not be taken for two||
4047|171|I|weeks before and after treatment with this medication. Ask your||
4047|172|I|doctor when to start or stop taking this medication.||
4047|173|I|   The risk of serotonin syndrome/toxicity increases if you are||
4047|174|I|also taking other drugs that increase serotonin. Examples include||
4047|175|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
4047|176|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
4047|177|I|SNRIs such as duloxetine/venlafaxine), tryptophan, among others.||
4047|178|I|The risk of serotonin syndrome/toxicity may be more likely when||
4047|179|I|you start or increase the dose of these drugs.||
4047|180|I|   Tell your doctor or pharmacist if you are taking other||
4047|181|I|products that cause drowsiness including alcohol, marijuana||
4047|182|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
4047|183|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
4047|184|I|zolpidem), muscle relaxants (such as carisoprodol,||
4047|185|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
4047|186|I|hydrocodone).||
4047|187|I|   Check the labels on all your medicines (such as allergy or||
4047|188|I|cough-and-cold products) because they may contain ingredients||
4047|189|I|that cause drowsiness. Ask your pharmacist about using those||
4047|190|I|products safely.||
4047|191|B|||
4047|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4047|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4047|194|O|poison control center right away. US residents can call||
4047|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4047|196|O|Symptoms of overdose may include: very fast/irregular heartbeat,||
4047|197|O|severe dizziness, fainting.||
4047|198|B|||
4047|199|N|NOTES:  Lab and/or medical tests should be done while you are||
4047|200|N|taking this medication. Keep all medical and lab appointments.||
4047|201|N|Consult your doctor for more details.||
4047|202|N|   Do not share this medication with others.||
4047|203|B|||
4047|204|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4047|205|D|If it is near the time of the next dose, skip the missed dose.||
4047|206|D|Use your next dose at the regular time. Do not double the dose to||
4047|207|D|catch up.||
4047|208|B|||
4047|209|R|STORAGE:  Store at room temperature away from light and moisture.||
4047|210|R|Do not store in the bathroom. Keep all medications away from||
4047|211|R|children and pets.||
4047|212|R|   Do not flush medications down the toilet or pour them into a||
4047|213|R|drain unless instructed to do so. Properly discard this product||
4047|214|R|when it is expired or no longer needed. Consult your pharmacist||
4047|215|R|or local waste disposal company.||
4047|216|B|||
4047|217|A|Information last revised May 2024.||
4047|218|A|Copyright(c) 2025 First Databank, Inc.||
4047|219|B|||
4049|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4049|002|Z|does NOT have all possible information about this product. This||
4049|003|Z|information does not assure that this product is safe, effective,||
4049|004|Z|or appropriate for you. This information is not individual||
4049|005|Z|medical advice and does not substitute for the advice of your||
4049|006|Z|health care professional. Always ask your health care||
4049|007|Z|professional for complete information about this product and your||
4049|008|Z|specific health needs.||
4049|009|B|||
4049|010|T|DICLOFENAC SODIUM ENTERIC-COATED TABLET - ORAL||
4049|011|F|(dye-KLOE-fen-ack SOE-dee-um)||
4049|012|B|||
4049|013|C|COMMON BRAND NAME(S): Voltaren||
4049|014|B|||
4049|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
4049|016|W|diclofenac) may rarely increase the risk of a heart attack or||
4049|017|W|stroke. This effect can happen at any time while taking this drug||
4049|018|W|but is more likely if you take it for a long time. The risk may||
4049|019|W|be greater in older adults or if you have heart disease or||
4049|020|W|increased risk for heart disease (for example, due to smoking,||
4049|021|W|family history of heart disease, or conditions such as high blood||
4049|022|W|pressure or diabetes). Do not take this drug right before or||
4049|023|W|after heart bypass surgery (CABG).||
4049|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
4049|025|W|bleeding from the stomach or intestines. This effect can occur||
4049|026|W|without warning symptoms at any time while taking this drug.||
4049|027|W|Older adults may be at higher risk for this effect.||
4049|028|W|   Stop taking diclofenac and get medical help right away if you||
4049|029|W|notice any of these rare but serious side effects:||
4049|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
4049|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
4049|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
4049|033|W|side of the body, trouble speaking, sudden vision changes.||
4049|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
4049|035|W|of taking this drug.||
4049|036|B|||
4049|037|U|USES:  See also Warning section.||
4049|038|U|   The enteric-coated tablet form of diclofenac is used to reduce||
4049|039|U|pain, swelling (inflammation), and joint stiffness from||
4049|040|U|arthritis. Reducing these symptoms helps you do more of your||
4049|041|U|normal daily activities.||
4049|042|U|   Diclofenac is known as a nonsteroidal anti-inflammatory drug||
4049|043|U|(NSAID). It works by blocking your body's production of certain||
4049|044|U|natural substances that cause inflammation. This effect helps to||
4049|045|U|decrease swelling, pain, or fever.||
4049|046|U|   Ask your doctor about non-drug treatments and/or using other||
4049|047|U|medications to treat your pain.||
4049|048|B|||
4049|049|V|OTHER USES:  This section contains uses of this drug that are not||
4049|050|V|listed in the approved professional labeling for the drug but||
4049|051|V|that may be prescribed by your health care professional. Use this||
4049|052|V|drug for a condition that is listed in this section only if it||
4049|053|V|has been so prescribed by your health care professional.||
4049|054|V|   This medication may also be used for gout, bursitis, or||
4049|055|V|tendonitis.||
4049|056|B|||
4049|057|H|HOW TO USE:  Read the Medication Guide provided by your||
4049|058|H|pharmacist before you start taking diclofenac and each time you||
4049|059|H|get a refill. If you have any questions, ask your doctor or||
4049|060|H|pharmacist.||
4049|061|H|   Take this medication by mouth as directed by your doctor,||
4049|062|H|usually 2-4 times a day. Take this medication with a full glass||
4049|063|H|of water (8 ounces/240 milliliters) unless your doctor directs||
4049|064|H|you otherwise. Do not lie down for at least 10 minutes after||
4049|065|H|taking this medication. If stomach upset occurs while taking this||
4049|066|H|medication, you may take it with food, milk, or an antacid.||
4049|067|H|However, this may slow absorption and delay pain relief.||
4049|068|H|   Swallow the tablets whole. Do not crush, chew, or break the||
4049|069|H|tablets. Doing so can increase stomach upset.||
4049|070|H|   There are different brands and forms of this medication||
4049|071|H|available. Because different forms do not have the same effects||
4049|072|H|at equal strengths, do not switch forms of diclofenac unless your||
4049|073|H|doctor tells you to.||
4049|074|H|   The dosage is based on your medical condition, response to||
4049|075|H|treatment, and other medications you may be taking. To reduce||
4049|076|H|your risk of stomach bleeding and other side effects, take this||
4049|077|H|medication at the lowest effective dose for the shortest possible||
4049|078|H|time. Do not increase your dose or take this drug more often or||
4049|079|H|for longer than prescribed. Discuss the risks and benefits with||
4049|080|H|your doctor or pharmacist.||
4049|081|H|   For certain conditions (such as arthritis), it may take up to||
4049|082|H|2 weeks of taking this drug regularly until you get the full||
4049|083|H|benefit.||
4049|084|H|   Tell your doctor if your condition gets worse.||
4049|085|B|||
4049|086|S|SIDE EFFECTS:  See also Warning section.||
4049|087|S|   Upset stomach, nausea, heartburn, diarrhea, constipation, gas,||
4049|088|S|headache, drowsiness, dizziness, or blurred vision may occur. If||
4049|089|S|any of these effects last or get worse, tell your doctor or||
4049|090|S|pharmacist promptly.||
4049|091|S|   Remember that this medication has been prescribed because your||
4049|092|S|doctor has judged that the benefit to you is greater than the||
4049|093|S|risk of side effects. Many people using this medication do not||
4049|094|S|have serious side effects.||
4049|095|S|   This medication may raise your blood pressure. Check your||
4049|096|S|blood pressure regularly and tell your doctor if the results are||
4049|097|S|high.||
4049|098|S|   Tell your doctor right away if you have any serious side||
4049|099|S|effects, including: hearing changes (such as ringing in the||
4049|100|S|ears), mental/mood changes, easy bleeding/bruising,||
4049|101|S|difficult/painful swallowing, signs of kidney problems (such as||
4049|102|S|change in the amount of urine, pink/bloody urine), symptoms of||
4049|103|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
4049|104|S|unusual/sudden weight gain).||
4049|105|S|   Diclofenac may rarely cause serious (possibly fatal) liver||
4049|106|S|disease. Get medical help right away if you have any symptoms of||
4049|107|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
4049|108|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
4049|109|S|urine.||
4049|110|S|   A very serious allergic reaction to this drug is rare.||
4049|111|S|However, get medical help right away if you notice any symptoms||
4049|112|S|of a serious allergic reaction, including: fever, swollen lymph||
4049|113|S|nodes, rash, itching/swelling (especially of the||
4049|114|S|face/tongue/throat), severe dizziness, trouble breathing.||
4049|115|S|   This is not a complete list of possible side effects. If you||
4049|116|S|notice other effects not listed above, contact your doctor or||
4049|117|S|pharmacist.||
4049|118|S|   In the US -||
4049|119|S|   Call your doctor for medical advice about side effects. You||
4049|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4049|121|S|www.fda.gov/medwatch.||
4049|122|S|   In Canada - Call your doctor for medical advice about side||
4049|123|S|effects. You may report side effects to Health Canada at||
4049|124|S|1-866-234-2345.||
4049|125|B|||
4049|126|P|PRECAUTIONS:  See also Warning section.||
4049|127|P|   Before taking diclofenac, tell your doctor or pharmacist if||
4049|128|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
4049|129|P|ibuprofen, naproxen, celecoxib); or if you have any other||
4049|130|P|allergies. This product may contain inactive ingredients, which||
4049|131|P|can cause allergic reactions or other problems. Talk to your||
4049|132|P|pharmacist for more details.||
4049|133|P|   Before using this medication, tell your doctor or pharmacist||
4049|134|P|your medical history, especially of: asthma (including a history||
4049|135|P|of worsening breathing after taking aspirin or other NSAIDs),||
4049|136|P|blood disorders (such as anemia, bleeding/clotting problems),||
4049|137|P|growths in the nose (nasal polyps), heart disease (such as||
4049|138|P|previous heart attack), high blood pressure, liver disease,||
4049|139|P|stroke, swelling (edema, fluid retention),||
4049|140|P|stomach/intestinal/esophagus problems (such as bleeding,||
4049|141|P|heartburn, ulcers).||
4049|142|P|   Kidney problems can sometimes occur with the use of NSAID||
4049|143|P|medications, including diclofenac. Problems are more likely to||
4049|144|P|occur if you are dehydrated, have heart failure or kidney||
4049|145|P|disease, are an older adult, or if you take certain medications||
4049|146|P|(see also Drug Interactions section). Drink plenty of fluids as||
4049|147|P|directed by your doctor to prevent dehydration and tell your||
4049|148|P|doctor right away if you have pink/bloody urine or any unusual||
4049|149|P|change in the amount of urine.||
4049|150|P|   This drug may make you dizzy or drowsy or cause blurred||
4049|151|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
4049|152|P|Do not drive, use machinery, or do anything that needs alertness||
4049|153|P|or clear vision until you can do it safely. Limit alcoholic||
4049|154|P|beverages. Talk to your doctor if you are using marijuana||
4049|155|P|(cannabis).||
4049|156|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
4049|157|P|and tobacco, especially when combined with this medicine, may||
4049|158|P|increase your risk for stomach bleeding. Limit alcohol and stop||
4049|159|P|smoking.||
4049|160|P|   This medication may make you more sensitive to the sun. Limit||
4049|161|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4049|162|P|sunscreen and wear protective clothing when outdoors. Tell your||
4049|163|P|doctor right away if you get sunburned or have skin||
4049|164|P|blisters/redness.||
4049|165|P|   Before having surgery, tell your doctor or dentist about all||
4049|166|P|the products you use (including prescription drugs,||
4049|167|P|nonprescription drugs, and herbal products).||
4049|168|P|   Older adults may be at greater risk for stomach/intestinal||
4049|169|P|bleeding, kidney problems, heart attack, and stroke while using||
4049|170|P|this drug.||
4049|171|P|   Before using this medication, women of childbearing age should||
4049|172|P|talk with their doctor(s) about the benefits and risks. Tell your||
4049|173|P|doctor if you are pregnant or if you plan to become pregnant.||
4049|174|P|This medication may harm an unborn baby and cause problems with||
4049|175|P|normal labor/delivery. It is not recommended for use in pregnancy||
4049|176|P|from 20 weeks until delivery. If your doctor decides that you||
4049|177|P|need to use this medication between 20 and 30 weeks of pregnancy,||
4049|178|P|you should use the lowest effective dose for the shortest||
4049|179|P|possible time. You should not use this medication after 30 weeks||
4049|180|P|of pregnancy.||
4049|181|P|   This medication passes into breast milk. Consult your doctor||
4049|182|P|before breastfeeding.||
4049|183|B|||
4049|184|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4049|185|I|medications work or increase your risk for serious side effects.||
4049|186|I|This document does not contain all possible drug interactions.||
4049|187|I|Keep a list of all the products you use (including||
4049|188|I|prescription/nonprescription drugs and herbal products) and share||
4049|189|I|it with your doctor and pharmacist. Do not start, stop, or change||
4049|190|I|the dosage of any medicines without your doctor's approval.||
4049|191|I|   Some products that may interact with this drug are: aliskiren,||
4049|192|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
4049|193|I|receptor blockers (such as losartan, valsartan), cidofovir,||
4049|194|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
4049|195|I|methotrexate, "water pills" (diuretics such as furosemide).||
4049|196|I|   This medication may increase the risk of bleeding when taken||
4049|197|I|with other drugs that also may cause bleeding. Examples include||
4049|198|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
4049|199|I|dabigatran/enoxaparin/warfarin, among others.||
4049|200|I|   Check all prescription and nonprescription medicine labels||
4049|201|I|carefully since many medications contain pain relievers/fever||
4049|202|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
4049|203|I|naproxen). These drugs are similar to diclofenac and may increase||
4049|204|I|your risk of side effects if taken together. However, if your||
4049|205|I|doctor has told you to take low-dose aspirin to prevent heart||
4049|206|I|attack or stroke (usually 81-162 milligrams a day), you should||
4049|207|I|keep taking the aspirin unless your doctor tells you not to. Ask||
4049|208|I|your doctor or pharmacist for more details.||
4049|209|B|||
4049|210|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4049|211|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4049|212|O|poison control center right away. US residents can call||
4049|213|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4049|214|O|Symptoms of overdose may include: severe stomach pain,||
4049|215|O|slow/shallow breathing, extreme drowsiness.||
4049|216|B|||
4049|217|N|NOTES:  Do not share this medication with others.||
4049|218|N|   Lab and/or medical tests (such as complete blood count,||
4049|219|N|liver/kidney function, blood pressure) may be done while you are||
4049|220|N|using this medication. Keep all medical and lab appointments.||
4049|221|N|Consult your doctor for more details.||
4049|222|N|   Lifestyle changes (such as weight loss if needed,||
4049|223|N|strengthening/conditioning exercises) may help improve your||
4049|224|N|flexibility and joint function. Consult your doctor for specific||
4049|225|N|instructions.||
4049|226|B|||
4049|227|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4049|228|D|remember. If it is near the time of the next dose, skip the||
4049|229|D|missed dose. Take your next dose at the regular time. Do not||
4049|230|D|double the dose to catch up.||
4049|231|B|||
4049|232|R|STORAGE:  Store at room temperature away from light and moisture.||
4049|233|R|Do not store in the bathroom. Keep all medications away from||
4049|234|R|children and pets.||
4049|235|R|   Do not flush medications down the toilet or pour them into a||
4049|236|R|drain unless instructed to do so. Properly discard this product||
4049|237|R|when it is expired or no longer needed. Consult your pharmacist||
4049|238|R|or local waste disposal company.||
4049|239|B|||
4049|240|A|Information last revised September 2024.||
4049|241|A|Copyright(c) 2025 First Databank, Inc.||
4049|242|B|||
4050|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4050|002|Z|does NOT have all possible information about this product. This||
4050|003|Z|information does not assure that this product is safe, effective,||
4050|004|Z|or appropriate for you. This information is not individual||
4050|005|Z|medical advice and does not substitute for the advice of your||
4050|006|Z|health care professional. Always ask your health care||
4050|007|Z|professional for complete information about this product and your||
4050|008|Z|specific health needs.||
4050|009|B|||
4050|010|T|CLOXACILLIN - ORAL||
4050|011|F|(klox-a-SIL-in)||
4050|012|B|||
4050|013|C|COMMON BRAND NAME(S): Tegopen||
4050|014|B|||
4050|015|U|USES:  Cloxacillin is used to treat a wide variety of bacterial||
4050|016|U|infections. This medication is a type of penicillin antibiotic.||
4050|017|U|It works by stopping the growth of bacteria.||
4050|018|U|   This antibiotic treats only bacterial infections. It will not||
4050|019|U|work for viral infections (such as common cold, flu). Using any||
4050|020|U|antibiotic when it is not needed can cause it to not work for||
4050|021|U|future infections.||
4050|022|B|||
4050|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
4050|024|H|doctor. This medication is best absorbed when taken on an empty||
4050|025|H|stomach (1 hour before or 2 hours after meals).||
4050|026|H|   If you are using the liquid suspension form of this medicine,||
4050|027|H|shake the bottle well before each dose.||
4050|028|H|   The dosage is based on your medical condition and response to||
4050|029|H|treatment. Children's dosage is also based on weight and age.||
4050|030|H|   For the best effect, take this antibiotic at evenly spaced||
4050|031|H|times. To help you remember, take this medication at the same||
4050|032|H|time(s) every day.||
4050|033|H|   Continue to take this medication until the full prescribed||
4050|034|H|amount is finished, even if symptoms disappear after a few days.||
4050|035|H|Stopping the medication too early may result in a return of the||
4050|036|H|infection.||
4050|037|H|   Tell your doctor if your condition lasts or gets worse.||
4050|038|B|||
4050|039|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, diarrhea, gas,||
4050|040|S|and mouth sores may occur. If any of these effects last or get||
4050|041|S|worse, tell your doctor or pharmacist promptly.||
4050|042|S|   Although uncommon, you may develop a black, "hairy" tongue||
4050|043|S|while taking this medication. This effect is harmless and usually||
4050|044|S|goes away after treatment. Maintain good oral hygiene, and brush||
4050|045|S|your tongue with a soft toothbrush twice a day. Consult your||
4050|046|S|doctor or pharmacist for more information.||
4050|047|S|   Remember that this medication has been prescribed because your||
4050|048|S|doctor has judged that the benefit to you is greater than the||
4050|049|S|risk of side effects. Many people using this medication do not||
4050|050|S|have serious side effects.||
4050|051|S|   Tell your doctor right away if you have any serious side||
4050|052|S|effects, including: nausea/vomiting that doesn't stop, unusual||
4050|053|S|tiredness, muscle aches, joint pain/swelling, easy||
4050|054|S|bruising/bleeding, signs of kidney problems (such as change in||
4050|055|S|the amount of urine, pink urine), dark urine, stomach/abdominal||
4050|056|S|pain, yellowing eyes/skin.||
4050|057|S|   This medication may rarely cause a severe intestinal condition||
4050|058|S|due to a bacteria called C. difficile. This condition may occur||
4050|059|S|during treatment or weeks to months after treatment has stopped.||
4050|060|S|Tell your doctor right away if you develop: diarrhea that doesn't||
4050|061|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
4050|062|S|stool.||
4050|063|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4050|064|S|products because they may make symptoms worse.||
4050|065|S|   Use of this medication for prolonged or repeated periods may||
4050|066|S|result in oral thrush or a new vaginal yeast infection (oral or||
4050|067|S|vaginal fungal infection). Contact your doctor if you notice||
4050|068|S|white patches in your mouth, a change in vaginal discharge or||
4050|069|S|other new symptoms.||
4050|070|S|   A very serious allergic reaction to this drug is rare.||
4050|071|S|However, get medical help right away if you notice any symptoms||
4050|072|S|of a serious allergic reaction, including: fever that doesn't go||
4050|073|S|away, new or worsening lymph node swelling, rash,||
4050|074|S|itching/swelling (especially of the face/tongue/throat), severe||
4050|075|S|dizziness, trouble breathing.||
4050|076|S|   This is not a complete list of possible side effects. If you||
4050|077|S|notice other effects not listed above, contact your doctor or||
4050|078|S|pharmacist.||
4050|079|S|   In the US -||
4050|080|S|   Call your doctor for medical advice about side effects. You||
4050|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4050|082|S|www.fda.gov/medwatch.||
4050|083|S|   In Canada - Call your doctor for medical advice about side||
4050|084|S|effects. You may report side effects to Health Canada at||
4050|085|S|1-866-234-2345.||
4050|086|B|||
4050|087|P|PRECAUTIONS:  Before taking cloxacillin, tell your doctor or||
4050|088|P|pharmacist if you are allergic to it; or to other antibiotics||
4050|089|P|including penicillin-type medications (such as amoxicillin,||
4050|090|P|ampicillin, penicillin) or cephalosporins (such as cephalexin,||
4050|091|P|cefuroxime); or if you have any other allergies. This product may||
4050|092|P|contain inactive ingredients, which can cause allergic reactions||
4050|093|P|or other problems. Talk to your pharmacist for more details.||
4050|094|P|   Before using this medication, tell your doctor or pharmacist||
4050|095|P|your medical history, especially of: kidney problems.||
4050|096|P|   Cloxacillin may cause live bacterial vaccines (such as typhoid||
4050|097|P|vaccine) to not work well. Tell your health care professional||
4050|098|P|that you are using cloxacillin before having any||
4050|099|P|immunizations/vaccinations.||
4050|100|P|   Older adults may be more sensitive to the side effects of this||
4050|101|P|drug.||
4050|102|P|   Newborns may be more sensitive to the side effects of this||
4050|103|P|drug.||
4050|104|P|   During pregnancy, this medication should be used only when||
4050|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
4050|106|P|   This drug passes into breast milk. Consult your doctor before||
4050|107|P|breastfeeding.||
4050|108|B|||
4050|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4050|110|I|medications work or increase your risk for serious side effects.||
4050|111|I|This document does not contain all possible drug interactions.||
4050|112|I|Keep a list of all the products you use (including||
4050|113|I|prescription/nonprescription drugs and herbal products) and share||
4050|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
4050|115|I|the dosage of any medicines without your doctor's approval.||
4050|116|I|   Some products that may interact with this drug are: fusidic||
4050|117|I|acid, methotrexate, tetracyclines, warfarin, khat, guar gum.||
4050|118|I|   This medication may interfere with certain lab tests (such as||
4050|119|I|certain diabetic urine tests), possibly causing false test||
4050|120|I|results. Make sure lab personnel and all your doctors know you||
4050|121|I|use this drug.||
4050|122|B|||
4050|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4050|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4050|125|O|poison control center right away. US residents can call||
4050|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4050|127|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
4050|128|O|severe vomiting.||
4050|129|B|||
4050|130|N|NOTES:  Do not share this medication with others.||
4050|131|N|   This medication has been prescribed for your current condition||
4050|132|N|only. Do not use it later for another infection unless your||
4050|133|N|doctor tells you to.||
4050|134|N|   With long-term treatment, lab and/or medical tests (such as||
4050|135|N|kidney and liver function, complete blood counts) should be done||
4050|136|N|while you are taking this medication. Keep all medical and lab||
4050|137|N|appointments. Consult your doctor for more details.||
4050|138|B|||
4050|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4050|140|D|remember. If it is near the time of the next dose, skip the||
4050|141|D|missed dose. Take your next dose at the regular time. Do not||
4050|142|D|double the dose to catch up.||
4050|143|B|||
4050|144|R|STORAGE:  Store the capsules at room temperature away from light||
4050|145|R|and moisture. Do not store in the bathroom. Store the suspension||
4050|146|R|in the refrigerator. Discard any unused portion of the suspension||
4050|147|R|after 14 days. Keep all medications away from children and pets.||
4050|148|R|   Do not flush medications down the toilet or pour them into a||
4050|149|R|drain unless instructed to do so. Properly discard this product||
4050|150|R|when it is expired or no longer needed. Consult your pharmacist||
4050|151|R|or local waste disposal company.||
4050|152|B|||
4050|153|A|Information last revised September 2024.||
4050|154|A|Copyright(c) 2025 First Databank, Inc.||
4050|155|B|||
4051|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4051|002|Z|does NOT have all possible information about this product. This||
4051|003|Z|information does not assure that this product is safe, effective,||
4051|004|Z|or appropriate for you. This information is not individual||
4051|005|Z|medical advice and does not substitute for the advice of your||
4051|006|Z|health care professional. Always ask your health care||
4051|007|Z|professional for complete information about this product and your||
4051|008|Z|specific health needs.||
4051|009|B|||
4051|010|T|NARATRIPTAN - ORAL||
4051|011|F|(nair-uh-TRIP-tan)||
4051|012|B|||
4051|013|C|COMMON BRAND NAME(S): Amerge||
4051|014|B|||
4051|015|U|USES:  This medication is used to treat migraines. It helps to||
4051|016|U|relieve headaches, pain and other symptoms of migraines,||
4051|017|U|including sensitivity to light/sound, nausea, and vomiting.||
4051|018|U|Prompt treatment allows you to get back to your normal routine||
4051|019|U|and may decrease your need for other pain medications.||
4051|020|U|Naratriptan does not prevent future migraines or reduce how often||
4051|021|U|you may get a headache.||
4051|022|U|   Naratriptan belongs to a group of drugs called triptans. It||
4051|023|U|affects a certain natural chemical (serotonin) that constricts||
4051|024|U|blood vessels in the brain. It may also block other pain pathways||
4051|025|U|in the brain.||
4051|026|B|||
4051|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4051|028|H|from your pharmacist before you start using naratriptan and each||
4051|029|H|time you get a refill. If you have any questions, ask your doctor||
4051|030|H|or pharmacist.||
4051|031|H|   Take one tablet by mouth with or without food as directed by||
4051|032|H|your doctor, usually at the first sign of a migraine. Do not take||
4051|033|H|naratriptan to prevent a migraine. If there is no improvement in||
4051|034|H|your symptoms, do not take any more doses of this medication||
4051|035|H|before talking to your doctor. If your symptoms are only partly||
4051|036|H|relieved, or if your headache comes back, you may take a second||
4051|037|H|dose after 4 hours or as directed by your doctor. Do not take||
4051|038|H|more than 5 milligrams in a 24-hour period.||
4051|039|H|   If you have never taken this medication before and you have||
4051|040|H|risk factors for heart disease (see Precautions), you may be||
4051|041|H|advised to take your first dose in your doctor's office in order||
4051|042|H|to monitor for rare but serious heart problems (such as heart||
4051|043|H|attack).||
4051|044|H|   The dosage is based on your medical condition and response to||
4051|045|H|treatment. Tell your doctor if your condition does not get better||
4051|046|H|or if it gets worse.||
4051|047|H|   If you are using drugs for migraine attacks on 10 or more days||
4051|048|H|each month, the drugs may actually make your headaches worse||
4051|049|H|(medication overuse headache). Do not use medications more often||
4051|050|H|or for longer than directed. Tell your doctor if you need to use||
4051|051|H|this medication more often, or if the medication is not working||
4051|052|H|as well, or if your headaches get worse.||
4051|053|B|||
4051|054|S|SIDE EFFECTS:  Flushing, sensations of||
4051|055|S|tingling/numbness/prickling/heat, weakness, drowsiness, or||
4051|056|S|dizziness may occur. If any of these effects last or get worse,||
4051|057|S|tell your doctor or pharmacist promptly.||
4051|058|S|   Remember that this medication has been prescribed because your||
4051|059|S|doctor has judged that the benefit to you is greater than the||
4051|060|S|risk of side effects. Many people using this medication do not||
4051|061|S|have serious side effects.||
4051|062|S|   This medication may raise your blood pressure. Check your||
4051|063|S|blood pressure regularly and tell your doctor if the results are||
4051|064|S|high.||
4051|065|S|   Tell your doctor right away if you have any serious side||
4051|066|S|effects, including: blue fingers/toes/nails, cold sensation of||
4051|067|S|hands/feet, hearing changes, mental/mood changes.||
4051|068|S|   Naratriptan can commonly cause chest/jaw/neck tightness, pain,||
4051|069|S|or pressure that is usually not serious. However, these side||
4051|070|S|effects are like symptoms of a heart attack, which may include||
4051|071|S|chest/jaw/left arm pain, shortness of breath, or unusual||
4051|072|S|sweating. Get medical help right away if these or other serious||
4051|073|S|side effects occur, including: fast/irregular heartbeat,||
4051|074|S|fainting, severe stomach/abdominal pain, bloody diarrhea, signs||
4051|075|S|of a stroke (such as weakness on one side of the body, trouble||
4051|076|S|speaking, sudden vision changes, confusion).||
4051|077|S|   This medication may increase serotonin and rarely cause a very||
4051|078|S|serious condition called serotonin syndrome/toxicity. The risk||
4051|079|S|increases if you are also taking other drugs that increase||
4051|080|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
4051|081|S|take (see Drug Interactions section). Get medical help right away||
4051|082|S|if you develop some of the following symptoms: fast heartbeat,||
4051|083|S|hallucinations, loss of coordination, severe dizziness, severe||
4051|084|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
4051|085|S|unusual agitation/restlessness.||
4051|086|S|   A very serious allergic reaction to this drug is rare.||
4051|087|S|However, get medical help right away if you notice any symptoms||
4051|088|S|of a serious allergic reaction, including: rash, itching/swelling||
4051|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4051|090|S|breathing.||
4051|091|S|   This is not a complete list of possible side effects. If you||
4051|092|S|notice other effects not listed above, contact your doctor or||
4051|093|S|pharmacist.||
4051|094|S|   In the US -||
4051|095|S|   Call your doctor for medical advice about side effects. You||
4051|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4051|097|S|www.fda.gov/medwatch.||
4051|098|S|   In Canada - Call your doctor for medical advice about side||
4051|099|S|effects. You may report side effects to Health Canada at||
4051|100|S|1-866-234-2345.||
4051|101|B|||
4051|102|P|PRECAUTIONS:  Before taking naratriptan, tell your doctor or||
4051|103|P|pharmacist if you are allergic to it; or to other triptan||
4051|104|P|migraine drugs; or it you have other allergies. This product may||
4051|105|P|contain inactive ingredients, which can cause allergic reactions||
4051|106|P|or other problems. Talk to your pharmacist for more details.||
4051|107|P|   Before using this medication, tell your doctor or pharmacist||
4051|108|P|your medical history, especially of: heart disease (such as chest||
4051|109|P|pain, heart attack, irregular heartbeat), decreased blood flow in||
4051|110|P|the brain (such as stroke, transient ischemic attack), blood||
4051|111|P|circulation disease (such as ischemic bowel disease, Raynaud's||
4051|112|P|disease), certain types of headaches (hemiplegic or basilar||
4051|113|P|migraine), kidney disease, liver disease.||
4051|114|P|   Tell your doctor if you have the following risk factors for||
4051|115|P|heart disease: diabetes, family history of heart disease, high||
4051|116|P|blood pressure, high cholesterol, overweight, smoker, female||
4051|117|P|after menopause, male over age 40.||
4051|118|P|   If you are at high risk for heart disease, your doctor may||
4051|119|P|want to check your heart before prescribing naratriptan.||
4051|120|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4051|121|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4051|122|P|machinery, or do anything that needs alertness until you can do||
4051|123|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
4051|124|P|are using marijuana (cannabis).||
4051|125|P|   Before having surgery, tell your doctor or dentist about all||
4051|126|P|the products you use (including prescription drugs,||
4051|127|P|nonprescription drugs, and herbal products).||
4051|128|P|   The risk of heart disease and high blood pressure increases||
4051|129|P|with age. Older adults may be more sensitive to the side effects||
4051|130|P|of this drug, especially increased blood pressure and heart||
4051|131|P|problems.||
4051|132|P|   During pregnancy, this medication should be used only when||
4051|133|P|clearly needed. Discuss the risks and benefits with your doctor.||
4051|134|P|   It is unknown if this drug passes into breast milk. Consult||
4051|135|P|your doctor before breastfeeding.||
4051|136|B|||
4051|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4051|138|I|medications work or increase your risk for serious side effects.||
4051|139|I|This document does not contain all possible drug interactions.||
4051|140|I|Keep a list of all the products you use (including||
4051|141|I|prescription/nonprescription drugs and herbal products) and share||
4051|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
4051|143|I|the dosage of any medicines without your doctor's approval.||
4051|144|I|   If you also take any ergotamine medication (such as||
4051|145|I|dihydroergotamine) or any other "triptan" drugs (such as||
4051|146|I|zolmitriptan, rizatriptan), you will need to separate your||
4051|147|I|naratriptan dose from your dose of these other medications in||
4051|148|I|order to lessen the chance of serious side effects. Ask you||
4051|149|I|doctor how long you should wait between your doses of these||
4051|150|I|drugs.||
4051|151|I|   The risk of serotonin syndrome/toxicity increases if you are||
4051|152|I|also taking other drugs that increase serotonin. Examples include||
4051|153|I|street drugs such as MDMA/"ecstasy,"St. John's wort, certain||
4051|154|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
4051|155|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
4051|156|I|serotonin syndrome/toxicity may be more likely when you start or||
4051|157|I|increase the dose of these drugs.||
4051|158|B|||
4051|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4051|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4051|161|O|poison control center right away. US residents can call||
4051|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4051|163|B|||
4051|164|N|NOTES:  Take this medication only as needed when a migraine||
4051|165|N|occurs, as directed by your doctor. This medication should not be||
4051|166|N|taken on a regular schedule. Never increase your dose of this||
4051|167|N|medication or take it more often than prescribed by your doctor.||
4051|168|N|   Certain foods/beverages or food additives (such as red wine,||
4051|169|N|cheese, chocolate, monosodium glutamate) as well as some||
4051|170|N|lifestyle patterns (such as irregular eating/sleeping habits,||
4051|171|N|stress) may bring about a migraine headache. Avoiding these||
4051|172|N|"triggers" may help decrease the frequency of migraine headaches.||
4051|173|N|Consult your doctor for more details.||
4051|174|N|   Lab and/or medical tests (such as blood pressure) may be done||
4051|175|N|while you are taking this medication. Keep all medical and lab||
4051|176|N|appointments. Consult your doctor for more details.||
4051|177|B|||
4051|178|D|MISSED DOSE:  Not applicable.||
4051|179|B|||
4051|180|R|STORAGE:  Store at room temperature away from light and moisture.||
4051|181|R|Do not store in the bathroom. Keep all medications away from||
4051|182|R|children and pets.||
4051|183|R|   Do not flush medications down the toilet or pour them into a||
4051|184|R|drain unless instructed to do so. Properly discard this product||
4051|185|R|when it is expired or no longer needed. Consult your pharmacist||
4051|186|R|or local waste disposal company.||
4051|187|B|||
4051|188|A|Information last revised November 2024.||
4051|189|A|Copyright(c) 2025 First Databank, Inc.||
4051|190|B|||
4052|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4052|002|Z|does NOT have all possible information about this product. This||
4052|003|Z|information does not assure that this product is safe, effective,||
4052|004|Z|or appropriate for you. This information is not individual||
4052|005|Z|medical advice and does not substitute for the advice of your||
4052|006|Z|health care professional. Always ask your health care||
4052|007|Z|professional for complete information about this product and your||
4052|008|Z|specific health needs.||
4052|009|B|||
4052|010|T|NAFTIFINE - TOPICAL||
4052|011|F|(NAFF-teh-feen)||
4052|012|B|||
4052|013|C|COMMON BRAND NAME(S): Naftin||
4052|014|B|||
4052|015|U|USES:  This medication is used to treat a variety of fungal skin||
4052|016|U|infections such as ringworm, athlete's foot, and jock itch.||
4052|017|U|Naftifine is an antifungal that works by preventing the growth of||
4052|018|U|fungus.||
4052|019|B|||
4052|020|H|HOW TO USE:  Use this medication on the skin only. Clean and||
4052|021|H|thoroughly dry the area to be treated. Apply a thin layer of the||
4052|022|H|medication to and around the affected area and gently rub in as||
4052|023|H|directed by your doctor, usually once daily if you are using the||
4052|024|H|cream, or twice daily (morning and evening) if you are using the||
4052|025|H|gel. Wash your hands after using unless the area to be treated||
4052|026|H|includes the hands. Do not wrap, cover, or bandage the area||
4052|027|H|unless directed to do so by your doctor.||
4052|028|H|   Do not use the medication in the eyes, nose, mouth, or inside||
4052|029|H|the vagina. If you do get the medication in those areas, flush||
4052|030|H|with plenty of water.||
4052|031|H|   Length of treatment is based on your medical condition and||
4052|032|H|response to treatment.||
4052|033|H|   Do not apply more often or use longer than prescribed. This||
4052|034|H|may increase the risk of side effects.||
4052|035|H|   Use this medication regularly to get the most benefit from it.||
4052|036|H|To help you remember, use it at the same time(s) each day.||
4052|037|H|   Continue to use this medication until the full prescribed||
4052|038|H|treatment period is finished, even if symptoms disappear after a||
4052|039|H|few days. Stopping the medication too early may result in a||
4052|040|H|return of the infection.||
4052|041|H|   Tell your doctor if your condition gets worse or if it does||
4052|042|H|not get better.||
4052|043|B|||
4052|044|S|SIDE EFFECTS:  Burning, stinging, irritation, redness, dry skin,||
4052|045|S|or itching at application site may occur. If any of these effects||
4052|046|S|last or get worse, tell your doctor or pharmacist promptly.||
4052|047|S|   Remember that this medication has been prescribed because your||
4052|048|S|doctor has judged that the benefit to you is greater than the||
4052|049|S|risk of side effects. Many people using this medication do not||
4052|050|S|have serious side effects.||
4052|051|S|   A very serious allergic reaction to this drug is rare.||
4052|052|S|However, get medical help right away if you notice any symptoms||
4052|053|S|of a serious allergic reaction, including: rash, itching/swelling||
4052|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4052|055|S|breathing.||
4052|056|S|   This is not a complete list of possible side effects. If you||
4052|057|S|notice other effects not listed above, contact your doctor or||
4052|058|S|pharmacist.||
4052|059|S|   In the US -||
4052|060|S|   Call your doctor for medical advice about side effects. You||
4052|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4052|062|S|www.fda.gov/medwatch.||
4052|063|S|   In Canada - Call your doctor for medical advice about side||
4052|064|S|effects. You may report side effects to Health Canada at||
4052|065|S|1-866-234-2345.||
4052|066|B|||
4052|067|P|PRECAUTIONS:  Before using naftifine, tell your doctor or||
4052|068|P|pharmacist if you are allergic to it; or to other allylamine||
4052|069|P|antifungals (such as terbinafine); or if you have any other||
4052|070|P|allergies. This product may contain inactive ingredients, which||
4052|071|P|can cause allergic reactions or other problems. Talk to your||
4052|072|P|pharmacist for more details.||
4052|073|P|   Before using this medication, tell your doctor or pharmacist||
4052|074|P|your medical history.||
4052|075|P|   Before having surgery, tell your doctor or dentist about all||
4052|076|P|the products you use (including prescription drugs,||
4052|077|P|nonprescription drugs, and herbal products).||
4052|078|P|   During pregnancy, this medication should be used only when||
4052|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
4052|080|P|   It is unknown if this drug passes into breast milk. Consult||
4052|081|P|your doctor before breastfeeding.||
4052|082|B|||
4052|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4052|084|I|medications work or increase your risk for serious side effects.||
4052|085|I|This document does not contain all possible drug interactions.||
4052|086|I|Keep a list of all the products you use (including||
4052|087|I|prescription/nonprescription drugs and herbal products) and share||
4052|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
4052|089|I|the dosage of any medicines without your doctor's approval.||
4052|090|B|||
4052|091|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
4052|092|O|has overdosed and has serious symptoms such as passing out or||
4052|093|O|trouble breathing, call 911. Otherwise, call a poison control||
4052|094|O|center right away. US residents can call 1-800-222-1222. Canada||
4052|095|O|residents can call 1-844-764-7669.||
4052|096|B|||
4052|097|N|NOTES:  Do not share this medication with others.||
4052|098|N|   This medication has been prescribed for your current condition||
4052|099|N|only. Do not use it later for another infection unless your||
4052|100|N|doctor tells you to.||
4052|101|B|||
4052|102|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4052|103|D|If it is near the time of the next dose, skip the missed dose.||
4052|104|D|Use your next dose at the regular time. Do not double the dose to||
4052|105|D|catch up.||
4052|106|B|||
4052|107|R|STORAGE:  Store at room temperature. Keep all medications away||
4052|108|R|from children and pets.||
4052|109|R|   Do not flush medications down the toilet or pour them into a||
4052|110|R|drain unless instructed to do so. Properly discard this product||
4052|111|R|when it is expired or no longer needed. Consult your pharmacist||
4052|112|R|or local waste disposal company.||
4052|113|B|||
4052|114|A|Information last revised November 2024.||
4052|115|A|Copyright(c) 2025 First Databank, Inc.||
4052|116|B|||
4060|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4060|002|Z|does NOT have all possible information about this product. This||
4060|003|Z|information does not assure that this product is safe, effective,||
4060|004|Z|or appropriate for you. This information is not individual||
4060|005|Z|medical advice and does not substitute for the advice of your||
4060|006|Z|health care professional. Always ask your health care||
4060|007|Z|professional for complete information about this product and your||
4060|008|Z|specific health needs.||
4060|009|B|||
4060|010|T|TAMSULOSIN CAPSULE - ORAL||
4060|011|F|(tam-SOO-loe-sin)||
4060|012|B|||
4060|013|C|COMMON BRAND NAME(S): Flomax||
4060|014|B|||
4060|015|U|USES:  Tamsulosin is used by men to treat the symptoms of an||
4060|016|U|enlarged prostate (benign prostatic hyperplasia-BPH). It does not||
4060|017|U|shrink the prostate, but it works by relaxing the muscles in the||
4060|018|U|prostate and the bladder. This helps to relieve symptoms of BPH||
4060|019|U|such as difficulty in beginning the flow of urine, weak stream,||
4060|020|U|and the need to urinate often or urgently (including during the||
4060|021|U|middle of the night). Tamsulosin belongs to a class of drugs||
4060|022|U|known as alpha blockers.||
4060|023|U|   Do not use this medication to treat high blood pressure.||
4060|024|B|||
4060|025|V|OTHER USES:  This section contains uses of this drug that are not||
4060|026|V|listed in the approved professional labeling for the drug but||
4060|027|V|that may be prescribed by your health care professional. Use this||
4060|028|V|drug for a condition that is listed in this section only if it||
4060|029|V|has been so prescribed by your health care professional.||
4060|030|V|   This drug may also be used to help your body "pass," or get||
4060|031|V|rid of, kidney stones through urination. It may also be used for||
4060|032|V|bladder problems in women.||
4060|033|B|||
4060|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4060|035|H|from your pharmacist before you start taking this medication and||
4060|036|H|each time you get a refill. If you have any questions, ask your||
4060|037|H|doctor or pharmacist.||
4060|038|H|   Take this medication by mouth as directed by your doctor,||
4060|039|H|usually once daily, 30 minutes after the same meal each day.||
4060|040|H|Swallow this medication whole. Do not crush, chew, or open the||
4060|041|H|capsules.||
4060|042|H|   The dosage is based on your medical condition and response to||
4060|043|H|treatment.||
4060|044|H|   Tamsulosin may cause a sudden drop in your blood pressure,||
4060|045|H|which could lead to dizziness or fainting. This risk is higher||
4060|046|H|when you first start taking this drug, after your doctor||
4060|047|H|increases your dose, or if you restart treatment after you stop||
4060|048|H|taking it. During these times, avoid situations where you may be||
4060|049|H|injured if you faint.||
4060|050|H|   Take this medication regularly to get the most benefit from||
4060|051|H|it. To help you remember, take it at the same time each day.||
4060|052|H|   If you have not taken this drug for several days, contact your||
4060|053|H|doctor to see if you need to be restarted at a lower dose.||
4060|054|H|   It may take up to 4 weeks before your symptoms improve. Tell||
4060|055|H|your doctor if your condition does not get better or if it gets||
4060|056|H|worse.||
4060|057|B|||
4060|058|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness,||
4060|059|S|runny/stuffy nose, or ejaculation problems may occur. If any of||
4060|060|S|these effects last or get worse, tell your doctor or pharmacist||
4060|061|S|promptly.||
4060|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
4060|063|S|slowly when rising from a sitting or lying position.||
4060|064|S|   Remember that this medication has been prescribed because your||
4060|065|S|doctor has judged that the benefit to you is greater than the||
4060|066|S|risk of side effects. Many people using this medication do not||
4060|067|S|have serious side effects.||
4060|068|S|   Tell your doctor right away if you have any serious side||
4060|069|S|effects, including: fainting.||
4060|070|S|   Rarely, males may have a painful or prolonged erection lasting||
4060|071|S|4 or more hours. If this occurs, stop using this drug and get||
4060|072|S|medical help right away, or permanent problems could occur.||
4060|073|S|   A very serious allergic reaction to this drug is rare.||
4060|074|S|However, get medical help right away if you notice any symptoms||
4060|075|S|of a serious allergic reaction, including: rash, itching/swelling||
4060|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4060|077|S|breathing.||
4060|078|S|   This is not a complete list of possible side effects. If you||
4060|079|S|notice other effects not listed above, contact your doctor or||
4060|080|S|pharmacist.||
4060|081|S|   In the US -||
4060|082|S|   Call your doctor for medical advice about side effects. You||
4060|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4060|084|S|www.fda.gov/medwatch.||
4060|085|S|   In Canada - Call your doctor for medical advice about side||
4060|086|S|effects. You may report side effects to Health Canada at||
4060|087|S|1-866-234-2345.||
4060|088|B|||
4060|089|P|PRECAUTIONS:  Before taking tamsulosin, tell your doctor or||
4060|090|P|pharmacist if you are allergic to it; or if you have any other||
4060|091|P|allergies. This product may contain inactive ingredients, which||
4060|092|P|can cause allergic reactions or other problems. Talk to your||
4060|093|P|pharmacist for more details.||
4060|094|P|   Before using this medication, tell your doctor or pharmacist||
4060|095|P|your medical history, especially of: low blood pressure, certain||
4060|096|P|eye problems (cataracts, glaucoma).||
4060|097|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4060|098|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4060|099|P|machinery, or do anything that needs alertness until you can do||
4060|100|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
4060|101|P|are using marijuana (cannabis).||
4060|102|P|   Before having surgery (including cataract/glaucoma eye||
4060|103|P|surgery), tell your doctor or dentist if you are taking or have||
4060|104|P|ever taken this medication, and about all the other products you||
4060|105|P|use (including prescription drugs, nonprescription drugs, and||
4060|106|P|herbal products).||
4060|107|P|   Older adults may be more sensitive to the side effects of this||
4060|108|P|drug, especially dizziness and low blood pressure when getting up||
4060|109|P|from a sitting or lying position. These side effects can increase||
4060|110|P|the risk of falling.||
4060|111|P|   During pregnancy, this medication should be used only when||
4060|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
4060|113|P|   It is unknown if this medication passes into breast milk.||
4060|114|P|Consult your doctor before breastfeeding.||
4060|115|B|||
4060|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4060|117|I|medications work or increase your risk for serious side effects.||
4060|118|I|This document does not contain all possible drug interactions.||
4060|119|I|Keep a list of all the products you use (including||
4060|120|I|prescription/nonprescription drugs and herbal products) and share||
4060|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
4060|122|I|the dosage of any medicines without your doctor's approval.||
4060|123|I|   Some products that may interact with this drug include: other||
4060|124|I|alpha blocker drugs (such as prazosin, terazosin).||
4060|125|I|   If you are also taking a drug to treat erectile dysfunction-ED||
4060|126|I|or pulmonary hypertension (such as sildenafil, tadalafil), your||
4060|127|I|blood pressure may get too low which can lead to dizziness or||
4060|128|I|fainting. Your doctor may need to adjust your medications to||
4060|129|I|minimize this risk.||
4060|130|I|   Other medications can affect the removal of tamsulosin from||
4060|131|I|your body, which may affect how tamsulosin works. Examples||
4060|132|I|include adagrasib, azole antifungals (such as itraconazole,||
4060|133|I|ketoconazole), clarithromycin, cobicistat, HIV protease||
4060|134|I|inhibitors (such as lopinavir), mifepristone, ribociclib,||
4060|135|I|ritonavir, among others.||
4060|136|B|||
4060|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4060|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4060|139|O|poison control center right away. US residents can call||
4060|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4060|141|O|Symptoms of overdose may include: severe dizziness, fainting.||
4060|142|B|||
4060|143|N|NOTES:  Do not share this medication with others.||
4060|144|N|   Lab and/or medical tests (such as prostate exams, blood||
4060|145|N|pressure) should be done while you are taking this medication.||
4060|146|N|Keep all medical and lab appointments. Consult your doctor for||
4060|147|N|more details.||
4060|148|B|||
4060|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4060|150|D|remember. If it is near the time of the next dose, skip the||
4060|151|D|missed dose. Take your next dose at the regular time. Do not||
4060|152|D|double the dose to catch up.||
4060|153|B|||
4060|154|R|STORAGE:  Store at room temperature away from light and moisture.||
4060|155|R|Do not store in the bathroom. Keep all medications away from||
4060|156|R|children and pets.||
4060|157|R|   Do not flush medications down the toilet or pour them into a||
4060|158|R|drain unless instructed to do so. Properly discard this product||
4060|159|R|when it is expired or no longer needed. Consult your pharmacist||
4060|160|R|or local waste disposal company.||
4060|161|B|||
4060|162|A|Information last revised November 2024.||
4060|163|A|Copyright(c) 2025 First Databank, Inc.||
4060|164|B|||
4061|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4061|002|Z|does NOT have all possible information about this product. This||
4061|003|Z|information does not assure that this product is safe, effective,||
4061|004|Z|or appropriate for you. This information is not individual||
4061|005|Z|medical advice and does not substitute for the advice of your||
4061|006|Z|health care professional. Always ask your health care||
4061|007|Z|professional for complete information about this product and your||
4061|008|Z|specific health needs.||
4061|009|B|||
4061|010|T|GLIMEPIRIDE - ORAL||
4061|011|F|(glye-MEP-ir-ide)||
4061|012|B|||
4061|013|C|COMMON BRAND NAME(S): Amaryl||
4061|014|B|||
4061|015|U|USES:  Glimepiride is used with a proper diet and exercise||
4061|016|U|program to control high blood sugar in people with type 2||
4061|017|U|diabetes. It may also be used with other diabetes medications.||
4061|018|U|Controlling high blood sugar helps prevent kidney damage,||
4061|019|U|blindness, nerve problems, loss of limbs, and sexual function||
4061|020|U|problems. Proper control of diabetes may also lessen your risk of||
4061|021|U|a heart attack or stroke. Glimepiride belongs to the class of||
4061|022|U|drugs known as sulfonylureas. It lowers blood sugar by causing||
4061|023|U|the release of your body's natural insulin.||
4061|024|B|||
4061|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4061|026|H|from your pharmacist before you start taking glimepiride and each||
4061|027|H|time you get a refill. If you have any questions, ask your doctor||
4061|028|H|or pharmacist.||
4061|029|H|   Take this medication by mouth with breakfast or the first main||
4061|030|H|meal of the day, as directed by your doctor, usually once daily.||
4061|031|H|The dosage is based on your medical condition and response to||
4061|032|H|treatment.||
4061|033|H|   Use this medication regularly to get the most benefit from it.||
4061|034|H|To help you remember, take it at the same time each day.||
4061|035|H|   To reduce your risk of side effects, your doctor may direct||
4061|036|H|you to start this medication at a low dose and gradually increase||
4061|037|H|your dose. Follow your doctor's instructions carefully.||
4061|038|H|   Colesevelam can decrease the absorption of glimepiride. If you||
4061|039|H|are taking colesevelam, take glimepiride at least 4 hours before||
4061|040|H|taking colesevelam.||
4061|041|H|   Tell your doctor if your condition does not get better or if||
4061|042|H|it gets worse (your blood sugar is too high or too low).||
4061|043|B|||
4061|044|S|SIDE EFFECTS:  Nausea and upset stomach may occur. If either of||
4061|045|S|these effects lasts or gets worse, tell your doctor or pharmacist||
4061|046|S|promptly.||
4061|047|S|   Remember that this medication has been prescribed because your||
4061|048|S|doctor has judged that the benefit to you is greater than the||
4061|049|S|risk of side effects. Many people using this medication do not||
4061|050|S|have serious side effects.||
4061|051|S|   Tell your doctor right away if you have any serious side||
4061|052|S|effects, including: yellowing eyes/skin, stomach/abdominal pain,||
4061|053|S|dark urine, unusual tiredness/weakness, easy bleeding/bruising,||
4061|054|S|signs of infection (such as sore throat that doesn't go away,||
4061|055|S|fever, chills), mental/mood changes, unusual/sudden weight gain,||
4061|056|S|seizures.||
4061|057|S|   This medication can cause low blood sugar (hypoglycemia). This||
4061|058|S|may occur if you do not get enough calories from food or if you||
4061|059|S|do unusually heavy exercise. Symptoms of low blood sugar include||
4061|060|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
4061|061|S|dizziness, or tingling hands/feet. It is a good habit to carry||
4061|062|S|glucose tablets or gel to treat low blood sugar. If you don't||
4061|063|S|have these reliable forms of glucose, rapidly raise your blood||
4061|064|S|sugar by eating a quick source of sugar such as table sugar,||
4061|065|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
4061|066|S|doctor right away about the reaction and the use of this product.||
4061|067|S|To help prevent low blood sugar, eat meals on a regular schedule,||
4061|068|S|and do not skip meals. Check with your doctor or pharmacist to||
4061|069|S|find out what you should do if you miss a meal.||
4061|070|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
4061|071|S|thirst/urination. If these symptoms occur, tell your doctor right||
4061|072|S|away. Your doctor may need to adjust your diabetes medication,||
4061|073|S|exercise program, or diet.||
4061|074|S|   A very serious allergic reaction to this drug is rare.||
4061|075|S|However, get medical help right away if you notice any symptoms||
4061|076|S|of a serious allergic reaction, including: rash, itching/swelling||
4061|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4061|078|S|breathing.||
4061|079|S|   This is not a complete list of possible side effects. If you||
4061|080|S|notice other effects not listed above, contact your doctor or||
4061|081|S|pharmacist.||
4061|082|S|   In the US -||
4061|083|S|   Call your doctor for medical advice about side effects. You||
4061|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4061|085|S|www.fda.gov/medwatch.||
4061|086|S|   In Canada - Call your doctor for medical advice about side||
4061|087|S|effects. You may report side effects to Health Canada at||
4061|088|S|1-866-234-2345.||
4061|089|B|||
4061|090|P|PRECAUTIONS:  Before taking glimepiride, tell your doctor or||
4061|091|P|pharmacist if you are allergic to it; or if you have any other||
4061|092|P|allergies. This product may contain inactive ingredients, which||
4061|093|P|can cause allergic reactions or other problems. Talk to your||
4061|094|P|pharmacist for more details.||
4061|095|P|   Before using this medication, tell your doctor or pharmacist||
4061|096|P|your medical history, especially of: liver disease, kidney||
4061|097|P|disease, thyroid disease, certain hormonal conditions||
4061|098|P|(adrenal/pituitary insufficiency, syndrome of inappropriate||
4061|099|P|secretion of antidiuretic hormone-SIADH), electrolyte imbalance||
4061|100|P|(hyponatremia).||
4061|101|P|   You may experience blurred vision, dizziness, or drowsiness||
4061|102|P|due to extremely low or high blood sugar. Do not drive, use||
4061|103|P|machinery, or do anything that needs alertness or clear vision||
4061|104|P|until you can do it safely.||
4061|105|P|   Limit alcohol while taking this medication because it can||
4061|106|P|increase your risk of developing low blood sugar.||
4061|107|P|   It may be harder to control your blood sugar when your body is||
4061|108|P|stressed (such as due to fever, infection, injury, or surgery).||
4061|109|P|Consult your doctor because this may require a change in your||
4061|110|P|treatment plan, medications, or blood sugar testing.||
4061|111|P|   This medication may make you more sensitive to the sun. Limit||
4061|112|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4061|113|P|sunscreen and wear protective clothing when outdoors. Tell your||
4061|114|P|doctor right away if you get sunburned or have skin||
4061|115|P|blisters/redness.||
4061|116|P|   Before having surgery, tell your doctor or dentist about all||
4061|117|P|the products you use (including prescription drugs,||
4061|118|P|nonprescription drugs, and herbal products).||
4061|119|P|   Older adults may be more sensitive to the side effects of this||
4061|120|P|drug, especially low blood sugar.||
4061|121|P|   During pregnancy, this medication should be used only when||
4061|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
4061|123|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
4061|124|P|your doctor for managing your blood sugar while pregnant. Your||
4061|125|P|doctor may change your diabetes treatment during your pregnancy||
4061|126|P|(such as diet and medications including insulin).||
4061|127|P|   It is unknown if this medication passes into breast milk.||
4061|128|P|Because of the possible risk to the infant, breastfeeding is not||
4061|129|P|recommended while using this medication. Consult your doctor||
4061|130|P|before breastfeeding.||
4061|131|B|||
4061|132|I|DRUG INTERACTIONS:  See also How to Use section.||
4061|133|I|   Drug interactions may change how your medications work or||
4061|134|I|increase your risk for serious side effects. This document does||
4061|135|I|not contain all possible drug interactions. Keep a list of all||
4061|136|I|the products you use (including prescription/nonprescription||
4061|137|I|drugs and herbal products) and share it with your doctor and||
4061|138|I|pharmacist. Do not start, stop, or change the dosage of any||
4061|139|I|medicines without your doctor's approval.||
4061|140|I|   Many drugs can affect your blood sugar, making it harder to||
4061|141|I|control. Before you start, stop, or change any medication, talk||
4061|142|I|with your doctor or pharmacist about how the medication may||
4061|143|I|affect your blood sugar. Check your blood sugar regularly as||
4061|144|I|directed and share the results with your doctor. Tell your doctor||
4061|145|I|right away if you have symptoms of high or low blood sugar. (See||
4061|146|I|also Side Effects section.) Your doctor may need to adjust your||
4061|147|I|diabetes medication, exercise program, or diet.||
4061|148|I|   Beta-blocker medications (including metoprolol, propranolol,||
4061|149|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
4061|150|I|heartbeat you would usually feel when your blood sugar falls too||
4061|151|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
4061|152|I|dizziness, hunger, or sweating are unaffected by these drugs.||
4061|153|B|||
4061|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4061|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4061|156|O|poison control center right away. US residents can call||
4061|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4061|158|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
4061|159|O|sweating, loss of consciousness.||
4061|160|B|||
4061|161|N|NOTES:  Do not share this medication with others.||
4061|162|N|   Attend a diabetes education program to learn more about how to||
4061|163|N|manage your diabetes with medications, diet, exercise, and||
4061|164|N|regular medical exams.||
4061|165|N|   Learn the symptoms of high and low blood sugar and how to||
4061|166|N|treat low blood sugar. Check your blood sugar regularly as||
4061|167|N|directed.||
4061|168|N|   Lab and/or medical tests (such as liver/kidney function,||
4061|169|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
4061|170|N|should be done while you are taking this medication. Keep all||
4061|171|N|medical and lab appointments. Consult your doctor for more||
4061|172|N|details.||
4061|173|B|||
4061|174|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
4061|175|D|you remember. If it is near the time of the next dose, skip the||
4061|176|D|missed dose. Take your next dose at the regular time. Do not||
4061|177|D|double the dose to catch up.||
4061|178|B|||
4061|179|R|STORAGE:  Store at room temperature away from light and moisture.||
4061|180|R|Do not store in the bathroom. Keep all medications away from||
4061|181|R|children and pets.||
4061|182|R|   Do not flush medications down the toilet or pour them into a||
4061|183|R|drain unless instructed to do so. Properly discard this product||
4061|184|R|when it is expired or no longer needed. Consult your pharmacist||
4061|185|R|or local waste disposal company.||
4061|186|B|||
4061|187|M|MEDICAL ALERT:  Your condition can cause complications in a||
4061|188|M|medical emergency. For information about enrolling in MedicAlert,||
4061|189|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4061|190|B|||
4061|191|A|Information last revised November 2025.||
4061|192|A|Copyright(c) 2025 First Databank, Inc.||
4061|193|B|||
4063|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4063|002|Z|does NOT have all possible information about this product. This||
4063|003|Z|information does not assure that this product is safe, effective,||
4063|004|Z|or appropriate for you. This information is not individual||
4063|005|Z|medical advice and does not substitute for the advice of your||
4063|006|Z|health care professional. Always ask your health care||
4063|007|Z|professional for complete information about this product and your||
4063|008|Z|specific health needs.||
4063|009|B|||
4063|010|T|PYRETHRINS AND PIPERONYL BUTOXIDE - TOPICAL||
4063|011|F|(pie-RETH-rins and pip-ER-oh-nill byoo-TOX-ide)||
4063|012|B|||
4063|013|C|COMMON BRAND NAME(S): Medi-Lice||
4063|014|B|||
4063|015|U|USES:  This medication is used to treat lice, which are tiny||
4063|016|U|insects that can infest and irritate the scalp (head lice), the||
4063|017|U|pubic area (crabs), or the body. This medication works by||
4063|018|U|paralyzing and killing lice.||
4063|019|B|||
4063|020|H|HOW TO USE:  Review the manufacturer's instruction sheet and||
4063|021|H|carefully follow all directions for your product. If any of this||
4063|022|H|information is unclear, talk to your doctor or pharmacist. Do not||
4063|023|H|use more drug than recommended.||
4063|024|H|   This medication is for use on the outside of the body only.||
4063|025|H|Avoid applying this drug to the eyes, nose, mouth, or vagina. If||
4063|026|H|this product gets in these areas, rinse with plenty of water. If||
4063|027|H|irritation occurs, tell your doctor promptly.||
4063|028|H|   Do not use this product on eyelashes or eyebrows. Check with||
4063|029|H|your doctor if these areas have lice.||
4063|030|H|   If applying this product to an infant, cover the infant's||
4063|031|H|hands and feet after applying the drug to make sure this product||
4063|032|H|does not get in the infant's mouth.||
4063|033|H|   Apply this drug in an area with good air flow (such as near an||
4063|034|H|open window).||
4063|035|H|   Apply this drug to the skin once, thoroughly covering the||
4063|036|H|affected area. Leave on for about 10 minutes or as long as||
4063|037|H|directed by your doctor. Then wash the affected area with warm||
4063|038|H|water and soap.||
4063|039|H|   Rinse and dry with a clean towel. For hairy areas, use a nit||
4063|040|H|removal comb (a fine-toothed comb) as directed. Wash hands||
4063|041|H|immediately after use.||
4063|042|H|   Because this product does not affect the eggs (nits) laid by||
4063|043|H|lice, repeat the application once 7 to 10 days later to kill any||
4063|044|H|newly hatched lice.||
4063|045|H|   Tell your doctor if your condition lasts or gets worse after||
4063|046|H|the 2 treatments with this medication.||
4063|047|B|||
4063|048|S|SIDE EFFECTS:  Skin irritation may occur. If this effect lasts or||
4063|049|S|gets worse, tell your doctor or pharmacist promptly.||
4063|050|S|   If your doctor has directed you to use this medication,||
4063|051|S|remember that your doctor has judged that the benefit to you is||
4063|052|S|greater than the risk of side effects. Many people using this||
4063|053|S|medication do not have serious side effects.||
4063|054|S|   A very serious allergic reaction to this drug is rare.||
4063|055|S|However, get medical help right away if you notice any symptoms||
4063|056|S|of a serious allergic reaction, including: rash, itching/swelling||
4063|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4063|058|S|breathing.||
4063|059|S|   This is not a complete list of possible side effects. If you||
4063|060|S|notice other effects not listed above, contact your doctor or||
4063|061|S|pharmacist.||
4063|062|S|   In the US -||
4063|063|S|   Call your doctor for medical advice about side effects. You||
4063|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4063|065|S|www.fda.gov/medwatch.||
4063|066|S|   In Canada - Call your doctor for medical advice about side||
4063|067|S|effects. You may report side effects to Health Canada at||
4063|068|S|1-866-234-2345.||
4063|069|B|||
4063|070|P|PRECAUTIONS:  Before using pyrethrins/piperonyl butoxide, tell||
4063|071|P|your doctor or pharmacist if you are allergic to it; or to||
4063|072|P|chrysanthemum or ragweed; or if you have any other allergies.||
4063|073|P|This product may contain inactive ingredients, which can cause||
4063|074|P|allergic reactions or other problems. Talk to your pharmacist for||
4063|075|P|more details.||
4063|076|P|   Before using this medication, tell your doctor or pharmacist||
4063|077|P|your medical history, especially of: skin infections.||
4063|078|P|   Constant or hard scratching of the skin/scalp may lead to a||
4063|079|P|bacterial skin infection. Tell your doctor right away if you||
4063|080|P|develop worsening redness or pus.||
4063|081|P|   During pregnancy, this medication should be used only when||
4063|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
4063|083|P|   It is unknown if this drug passes into breast milk. Consult||
4063|084|P|your doctor before breastfeeding.||
4063|085|B|||
4063|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4063|087|I|medications work or increase your risk for serious side effects.||
4063|088|I|This document does not contain all possible drug interactions.||
4063|089|I|Keep a list of all the products you use (including||
4063|090|I|prescription/nonprescription drugs and herbal products) and share||
4063|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
4063|092|I|the dosage of any medicines without your doctor's approval.||
4063|093|B|||
4063|094|O|OVERDOSE:  This medicine may be harmful if inhaled or swallowed.||
4063|095|O|If someone has overdosed and has serious symptoms such as passing||
4063|096|O|out or trouble breathing, call 911. Otherwise, call a poison||
4063|097|O|control center right away. US residents can call 1-800-222-1222.||
4063|098|O|Canada residents can call 1-844-764-7669. Symptoms of overdose||
4063|099|O|may include: nausea, vomiting, diarrhea, unusual drowsiness.||
4063|100|B|||
4063|101|N|NOTES:  Do not share this medication with anyone else unless||
4063|102|N|directed by your doctor.||
4063|103|N|   To avoid giving lice to another person or getting them again,||
4063|104|N|all headwear, scarves, coats, and bed linens should be||
4063|105|N|machine-washed with hot water and dried in a dryer (at high||
4063|106|N|setting) for at least 20 minutes. These items may also be dry||
4063|107|N|cleaned, sealed in a plastic bag for 2 weeks, or sprayed with a||
4063|108|N|disinfectant that kills lice. Brushes and combs should be soaked||
4063|109|N|in hot water (hotter than 130 degrees F/54 degrees C) for 10||
4063|110|N|minutes, soaked in alcohol for 1 hour, or thrown away. Furniture||
4063|111|N|and floors should be thoroughly vacuumed.||
4063|112|N|   People who are in close contact with the infected person, such||
4063|113|N|as members of the same household, should also be checked for lice||
4063|114|N|and nits. Treatment may be considered to prevent infestation,||
4063|115|N|even if live lice are not found on them.||
4063|116|B|||
4063|117|D|MISSED DOSE:  If you miss a dose, consult your doctor or||
4063|118|D|pharmacist.||
4063|119|B|||
4063|120|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
4063|121|R|medications away from children and pets.||
4063|122|R|   Do not flush medications down the toilet or pour them into a||
4063|123|R|drain unless instructed to do so. Properly discard this product||
4063|124|R|when it is expired or no longer needed. Consult your pharmacist||
4063|125|R|or local waste disposal company.||
4063|126|B|||
4063|127|A|Information last revised September 2024.||
4063|128|A|Copyright(c) 2025 First Databank, Inc.||
4063|129|B|||
4065|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4065|002|Z|does NOT have all possible information about this product. This||
4065|003|Z|information does not assure that this product is safe, effective,||
4065|004|Z|or appropriate for you. This information is not individual||
4065|005|Z|medical advice and does not substitute for the advice of your||
4065|006|Z|health care professional. Always ask your health care||
4065|007|Z|professional for complete information about this product and your||
4065|008|Z|specific health needs.||
4065|009|B|||
4065|010|T|RIFAPENTINE - ORAL||
4065|011|F|(riff-uh-PEN-teen)||
4065|012|B|||
4065|013|C|COMMON BRAND NAME(S): Priftin||
4065|014|B|||
4065|015|U|USES:  This medication is used with other medications to treat||
4065|016|U|active tuberculosis (TB) of the lungs. It may also be used with||
4065|017|U|another medication (isoniazid) to prevent active TB infections in||
4065|018|U|people who are infected with the bacteria (people with positive||
4065|019|U|TB skin test). Rifapentine is known as a rifamycin antibiotic. It||
4065|020|U|works by stopping the growth of bacteria.||
4065|021|U|   This antibiotic treats only bacterial infections. It will not||
4065|022|U|work for viral infections (such as common cold, flu). Using any||
4065|023|U|antibiotic when it is not needed can cause it to not work for||
4065|024|U|future infections.||
4065|025|B|||
4065|026|H|HOW TO USE:  Read the Medication Guide provided by your||
4065|027|H|pharmacist before you start taking rifapentine and each time you||
4065|028|H|get a refill. If you have any questions, ask your doctor or||
4065|029|H|pharmacist.||
4065|030|H|   Take this medication by mouth with food as directed by your||
4065|031|H|doctor, usually once or twice weekly. Taking this medication with||
4065|032|H|food will help to decrease side effects such as stomach upset,||
4065|033|H|nausea, and vomiting and also increase the absorption of this||
4065|034|H|medication.||
4065|035|H|   The dosage is based on your weight, medical condition, and||
4065|036|H|response to treatment.||
4065|037|H|   For the best effect, take this antibiotic at evenly spaced||
4065|038|H|times. To help you remember, take it on the same day(s) and time||
4065|039|H|each week. Mark your calendar with a reminder.||
4065|040|H|   Continue to take this medication (and other TB medications)||
4065|041|H|until the full prescribed amount is finished, even if symptoms||
4065|042|H|disappear. Stopping the medication too early or skipping doses||
4065|043|H|may result in a return of the infection and cause the infection||
4065|044|H|to be more difficult to treat (resistant).||
4065|045|H|   Tell your doctor if your condition lasts or gets worse.||
4065|046|B|||
4065|047|S|SIDE EFFECTS:  Stomach upset, nausea, vomiting, loss of appetite,||
4065|048|S|or headache may occur. If any of these effects last or get worse,||
4065|049|S|tell your doctor or pharmacist promptly.||
4065|050|S|   This medication may cause urine, sweat, saliva, or tears to||
4065|051|S|turn reddish. This effect is harmless and will disappear when the||
4065|052|S|medication is stopped. However, dentures and contact lenses may||
4065|053|S|be permanently stained.||
4065|054|S|   Remember that this medication has been prescribed because your||
4065|055|S|doctor has judged that the benefit to you is greater than the||
4065|056|S|risk of side effects. Many people using this medication do not||
4065|057|S|have serious side effects.||
4065|058|S|   Tell your doctor right away if you have any serious side||
4065|059|S|effects, including: symptoms of liver disease (such as||
4065|060|S|nausea/vomiting that doesn't stop, unusual tiredness/weakness,||
4065|061|S|severe stomach/abdominal pain, yellowing eyes/skin, dark urine),||
4065|062|S|painful/swollen joints, dark/bloody urine, easy||
4065|063|S|bleeding/bruising, unusual tiredness.||
4065|064|S|   This medication may rarely cause a severe intestinal condition||
4065|065|S|due to a bacteria called C. difficile. This condition may occur||
4065|066|S|during treatment or weeks to months after treatment has stopped.||
4065|067|S|Tell your doctor right away if you develop: diarrhea that doesn't||
4065|068|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
4065|069|S|stool.||
4065|070|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4065|071|S|products because they may make symptoms worse.||
4065|072|S|   A very serious allergic reaction to this drug is rare.||
4065|073|S|However, get medical help right away if you notice any symptoms||
4065|074|S|of a serious allergic reaction, including: fever that doesn't go||
4065|075|S|away, new or worsening lymph node swelling, rash,||
4065|076|S|itching/swelling (especially of the face/tongue/throat), severe||
4065|077|S|dizziness, trouble breathing.||
4065|078|S|   This is not a complete list of possible side effects. If you||
4065|079|S|notice other effects not listed above, contact your doctor or||
4065|080|S|pharmacist.||
4065|081|S|   In the US -||
4065|082|S|   Call your doctor for medical advice about side effects. You||
4065|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4065|084|S|www.fda.gov/medwatch.||
4065|085|S|   In Canada - Call your doctor for medical advice about side||
4065|086|S|effects. You may report side effects to Health Canada at||
4065|087|S|1-866-234-2345.||
4065|088|B|||
4065|089|P|PRECAUTIONS:  Before taking rifapentine, tell your doctor or||
4065|090|P|pharmacist if you are allergic to it; or to other rifamycins||
4065|091|P|(such as rifampin); or if you have any other allergies. This||
4065|092|P|product may contain inactive ingredients, which can cause||
4065|093|P|allergic reactions or other problems. Talk to your pharmacist for||
4065|094|P|more details.||
4065|095|P|   Before using this medication, tell your doctor or pharmacist||
4065|096|P|your medical history, especially of: HIV infection, a certain||
4065|097|P|blood disorder (porphyria), liver disease, alcohol use.||
4065|098|P|   Alcohol may increase the risk of liver disease. Avoid||
4065|099|P|alcoholic beverages while using this medication.||
4065|100|P|   Before having surgery, tell your doctor or dentist about all||
4065|101|P|the products you use (including prescription drugs,||
4065|102|P|nonprescription drugs, and herbal products).||
4065|103|P|   Rifapentine may cause live bacterial vaccines (such as typhoid||
4065|104|P|vaccine) to not work well. Tell your health care professional||
4065|105|P|that you are using rifapentine before having any||
4065|106|P|immunizations/vaccinations.||
4065|107|P|   During pregnancy, this medication should be used only when||
4065|108|P|clearly needed. When this drug is taken during the last few weeks||
4065|109|P|of pregnancy, the risk of bleeding in both mother and infant may||
4065|110|P|be increased. Tell your doctor right away if you notice any||
4065|111|P|bleeding in your newborn. Discuss the risks and benefits with||
4065|112|P|your doctor.||
4065|113|P|   It is unknown if rifapentine passes into breast milk. However,||
4065|114|P|similar drugs pass into breast milk. Consult your doctor before||
4065|115|P|breastfeeding.||
4065|116|B|||
4065|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4065|118|I|medications work or increase your risk for serious side effects.||
4065|119|I|This document does not contain all possible drug interactions.||
4065|120|I|Keep a list of all the products you use (including||
4065|121|I|prescription/nonprescription drugs and herbal products) and share||
4065|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
4065|123|I|the dosage of any medicines without your doctor's approval.||
4065|124|I|   Rifapentine can speed up the removal of other medications from||
4065|125|I|your body, which may affect how they work. Examples of affected||
4065|126|I|drugs include digoxin, phenytoin, ranolazine, tacrolimus, "blood||
4065|127|I|thinners" (such as warfarin), calcium channel blockers (such as||
4065|128|I|diltiazem, verapamil), HIV NNRTIs (such as etravirine,||
4065|129|I|nevirapine), HIV protease inhibitors (such as atazanavir,||
4065|130|I|darunavir), among others.||
4065|131|I|   This medication may decrease the effectiveness of hormonal||
4065|132|I|birth control such as pills, patch, or ring. This could cause||
4065|133|I|pregnancy. Discuss with your doctor or pharmacist if you should||
4065|134|I|use reliable backup birth control methods while using this||
4065|135|I|medication. Also tell your doctor if you have any new spotting or||
4065|136|I|breakthrough bleeding, because these may be signs that your birth||
4065|137|I|control is not working well.||
4065|138|I|   This medication may interfere with certain lab tests (such as||
4065|139|I|folate and vitamin B12 levels), possibly causing false test||
4065|140|I|results. Make sure lab personnel and all your doctors know you||
4065|141|I|use this drug.||
4065|142|B|||
4065|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4065|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4065|145|O|poison control center right away. US residents can call||
4065|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4065|147|B|||
4065|148|N|NOTES:  Do not share this medication with others.||
4065|149|N|   Lab and/or medical tests (such as sputum test, liver function,||
4065|150|N|bilirubin levels, complete blood count) should be done while you||
4065|151|N|are taking this medication. Keep all medical and lab||
4065|152|N|appointments. Consult your doctor for more details.||
4065|153|B|||
4065|154|D|MISSED DOSE:  It is important to take each dose of this||
4065|155|D|medication as scheduled. If you miss a dose and remember on the||
4065|156|D|same day, take it as soon as you remember. If you remember on the||
4065|157|D|next day or later, ask your doctor or pharmacist right away for a||
4065|158|D|new dosing schedule. Do not double the dose to catch up.||
4065|159|B|||
4065|160|R|STORAGE:  Store at room temperature away from light and moisture.||
4065|161|R|Do not store in the bathroom. Keep all medications away from||
4065|162|R|children and pets.||
4065|163|R|   Do not flush medications down the toilet or pour them into a||
4065|164|R|drain unless instructed to do so. Properly discard this product||
4065|165|R|when it is expired or no longer needed. Consult your pharmacist||
4065|166|R|or local waste disposal company.||
4065|167|B|||
4065|168|A|Information last revised March 2025.||
4065|169|A|Copyright(c) 2025 First Databank, Inc.||
4065|170|B|||
4070|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4070|002|Z|does NOT have all possible information about this product. This||
4070|003|Z|information does not assure that this product is safe, effective,||
4070|004|Z|or appropriate for you. This information is not individual||
4070|005|Z|medical advice and does not substitute for the advice of your||
4070|006|Z|health care professional. Always ask your health care||
4070|007|Z|professional for complete information about this product and your||
4070|008|Z|specific health needs.||
4070|009|B|||
4070|010|T|PROPAFENONE - ORAL||
4070|011|F|(pro-puh-FEN-own)||
4070|012|B|||
4070|013|C|COMMON BRAND NAME(S): Rythmol||
4070|014|B|||
4070|015|W|WARNING:  Though this medication often gives great benefits to||
4070|016|W|people with irregular heartbeat, it may rarely cause a serious||
4070|017|W|new irregular heartbeat. When starting treatment with this drug,||
4070|018|W|your doctor may recommend that you stay in the hospital for||
4070|019|W|proper monitoring and emergency medical treatment if needed. Talk||
4070|020|W|with your doctor about the benefits and risks of taking this||
4070|021|W|medication.||
4070|022|B|||
4070|023|U|USES:  This medication is used to treat certain types of serious||
4070|024|U|(possibly fatal) irregular heartbeat (such as paroxysmal||
4070|025|U|supraventricular tachycardia and atrial fibrillation). It is used||
4070|026|U|to restore normal heart rhythm and maintain a regular, steady||
4070|027|U|heartbeat. Propafenone is known as an anti-arrhythmic drug. It||
4070|028|U|works by blocking the activity of certain electrical signals in||
4070|029|U|the heart that can cause an irregular heartbeat. Treating an||
4070|030|U|irregular heartbeat can decrease the risk for blood clots, and||
4070|031|U|this effect can reduce your risk of heart attack or stroke.||
4070|032|B|||
4070|033|H|HOW TO USE:  Take this medication by mouth with or without food||
4070|034|H|as directed by your doctor, usually every 8 hours.||
4070|035|H|   The dosage is based on your medical condition and response to||
4070|036|H|treatment.||
4070|037|H|   Use this medication regularly to get the most benefit from it.||
4070|038|H|To help you remember, take it at the same times each day.||
4070|039|H|   Avoid eating grapefruit or drinking grapefruit juice while||
4070|040|H|using this medication unless your doctor or pharmacist says you||
4070|041|H|may do so safely. Grapefruit can increase the chance of side||
4070|042|H|effects with this medicine. Ask your doctor or pharmacist for||
4070|043|H|more details.||
4070|044|H|   Tell your doctor if your condition does not get better or if||
4070|045|H|it gets worse.||
4070|046|B|||
4070|047|S|SIDE EFFECTS:  See also Warning section.||
4070|048|S|   Dizziness, headache, metallic/salty taste in the mouth,||
4070|049|S|nausea/vomiting, constipation, anxiety, and tiredness may occur.||
4070|050|S|If any of these effects last or get worse, tell your doctor or||
4070|051|S|pharmacist promptly.||
4070|052|S|   Remember that this medication has been prescribed because your||
4070|053|S|doctor has judged that the benefit to you is greater than the||
4070|054|S|risk of side effects. Many people using this medication do not||
4070|055|S|have serious side effects.||
4070|056|S|   Tell your doctor right away if you have any serious side||
4070|057|S|effects, including: signs of infection (such as sore throat that||
4070|058|S|doesn't go away, fever, chills), signs of liver problems (such as||
4070|059|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
4070|060|S|yellowing eyes/skin, dark urine), worsening symptoms of heart||
4070|061|S|failure (such as shortness of breath, swelling ankles/feet,||
4070|062|S|unusual tiredness, unusual/sudden weight gain).||
4070|063|S|   Get medical help right away if you have any very serious side||
4070|064|S|effects, including: fainting, faster/more irregular heartbeat,||
4070|065|S|severe dizziness.||
4070|066|S|   A very serious allergic reaction to this drug is rare.||
4070|067|S|However, get medical help right away if you notice any symptoms||
4070|068|S|of a serious allergic reaction, including: rash, itching/swelling||
4070|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4070|070|S|breathing.||
4070|071|S|   This is not a complete list of possible side effects. If you||
4070|072|S|notice other effects not listed above, contact your doctor or||
4070|073|S|pharmacist.||
4070|074|S|   In the US -||
4070|075|S|   Call your doctor for medical advice about side effects. You||
4070|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4070|077|S|www.fda.gov/medwatch.||
4070|078|S|   In Canada - Call your doctor for medical advice about side||
4070|079|S|effects. You may report side effects to Health Canada at||
4070|080|S|1-866-234-2345.||
4070|081|B|||
4070|082|P|PRECAUTIONS:  Before taking propafenone, tell your doctor or||
4070|083|P|pharmacist if you are allergic to it; or if you have any other||
4070|084|P|allergies. This product may contain inactive ingredients, which||
4070|085|P|can cause allergic reactions or other problems. Talk to your||
4070|086|P|pharmacist for more details.||
4070|087|P|   Before using this medication, tell your doctor or pharmacist||
4070|088|P|your medical history, especially of: breathing problems (such as||
4070|089|P|asthma, chronic bronchitis, emphysema), kidney problems, liver||
4070|090|P|problems, myasthenia gravis, a certain inherited heart condition||
4070|091|P|(Brugada Syndrome).||
4070|092|P|   Propafenone may cause a condition that affects the heart||
4070|093|P|rhythm (QT prolongation). QT prolongation can rarely cause||
4070|094|P|serious (rarely fatal) fast/irregular heartbeat and other||
4070|095|P|symptoms (such as severe dizziness, fainting) that need medical||
4070|096|P|attention right away.||
4070|097|P|   The risk of QT prolongation may be increased if you have||
4070|098|P|certain medical conditions or are taking other drugs that may||
4070|099|P|cause QT prolongation. Before using propafenone, tell your doctor||
4070|100|P|or pharmacist of all the drugs you take and if you have any of||
4070|101|P|the following conditions: certain heart problems (heart failure,||
4070|102|P|slow heartbeat, QT prolongation in the EKG), family history of||
4070|103|P|certain heart problems (QT prolongation in the EKG, sudden||
4070|104|P|cardiac death).||
4070|105|P|   Low levels of potassium or magnesium in the blood may also||
4070|106|P|increase your risk of QT prolongation. This risk may increase if||
4070|107|P|you use certain drugs (such as diuretics/"water pills") or if you||
4070|108|P|have conditions such as severe sweating, diarrhea, or vomiting.||
4070|109|P|Talk to your doctor about using propafenone safely.||
4070|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4070|111|P|can make you more dizzy. Do not drive, use machinery, or do||
4070|112|P|anything that needs alertness until you can do it safely. Limit||
4070|113|P|alcoholic beverages. Talk to your doctor if you are using||
4070|114|P|marijuana (cannabis).||
4070|115|P|   Before having surgery, tell your doctor or dentist about all||
4070|116|P|the products you use (including prescription drugs,||
4070|117|P|nonprescription drugs, and herbal products).||
4070|118|P|   Older adults may be more sensitive to the side effects of this||
4070|119|P|drug, especially QT prolongation (see above).||
4070|120|P|   This medication can affect fertility in males. Ask your doctor||
4070|121|P|for more details.||
4070|122|P|   During pregnancy, this medication should be used only when||
4070|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
4070|124|P|   This medication passes into breast milk. Consult your doctor||
4070|125|P|before breastfeeding.||
4070|126|B|||
4070|127|I|DRUG INTERACTIONS:  See also How to Use section.||
4070|128|I|   Drug interactions may change how your medications work or||
4070|129|I|increase your risk for serious side effects. This document does||
4070|130|I|not contain all possible drug interactions. Keep a list of all||
4070|131|I|the products you use (including prescription/nonprescription||
4070|132|I|drugs and herbal products) and share it with your doctor and||
4070|133|I|pharmacist. Do not start, stop, or change the dosage of any||
4070|134|I|medicines without your doctor's approval.||
4070|135|I|   Many drugs besides propafenone may affect the heart rhythm (QT||
4070|136|I|prolongation), including amiodarone, dofetilide, flecainide,||
4070|137|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
4070|138|I|(such as clarithromycin, erythromycin), among others.||
4070|139|I|   Other medications can affect the removal of propafenone from||
4070|140|I|your body, which may affect how propafenone works. Examples||
4070|141|I|include desipramine, ketoconazole, orlistat, phenobarbital,||
4070|142|I|phenytoin, ritonavir, certain HIV protease inhibitors (such as||
4070|143|I|tipranavir), among others.||
4070|144|I|   Propafenone can slow down the removal of other medications||
4070|145|I|from your body, which may affect how they work. Examples of||
4070|146|I|affected drugs include digoxin, fezolinetant, imipramine,||
4070|147|I|metoprolol, propranolol, warfarin, among others.||
4070|148|B|||
4070|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4070|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4070|151|O|poison control center right away. US residents can call||
4070|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4070|153|O|Symptoms of overdose may include: severe dizziness, very slow||
4070|154|O|heartbeat, new irregular heartbeat, fainting.||
4070|155|B|||
4070|156|N|NOTES:  Do not share this medication with others.||
4070|157|N|   Lab and/or medical tests (such as EKG) should be done while||
4070|158|N|you are taking this medication. Keep all medical and lab||
4070|159|N|appointments. Consult your doctor for more details.||
4070|160|B|||
4070|161|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4070|162|D|remember. If it is near the time of the next dose, skip the||
4070|163|D|missed dose. Take your next dose at the regular time. Do not||
4070|164|D|double the dose to catch up.||
4070|165|B|||
4070|166|R|STORAGE:  Store at room temperature away from light and moisture.||
4070|167|R|Do not store in the bathroom. Keep all medications away from||
4070|168|R|children and pets.||
4070|169|R|   Do not flush medications down the toilet or pour them into a||
4070|170|R|drain unless instructed to do so. Properly discard this product||
4070|171|R|when it is expired or no longer needed. Consult your pharmacist||
4070|172|R|or local waste disposal company.||
4070|173|B|||
4070|174|M|MEDICAL ALERT:  Your condition can cause complications in a||
4070|175|M|medical emergency. For information about enrolling in MedicAlert,||
4070|176|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4070|177|B|||
4070|178|A|Information last revised May 2025.||
4070|179|A|Copyright(c) 2025 First Databank, Inc.||
4070|180|B|||
4071|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4071|002|Z|does NOT have all possible information about this product. This||
4071|003|Z|information does not assure that this product is safe, effective,||
4071|004|Z|or appropriate for you. This information is not individual||
4071|005|Z|medical advice and does not substitute for the advice of your||
4071|006|Z|health care professional. Always ask your health care||
4071|007|Z|professional for complete information about this product and your||
4071|008|Z|specific health needs.||
4071|009|B|||
4071|010|T|SULFADIAZINE - ORAL||
4071|011|F|(sull-fuh-DYE-uh-zeen)||
4071|012|B|||
4071|013|U|USES:  This medication is used to treat and prevent a wide||
4071|014|U|variety of infections. Sulfadiazine belongs to the class of drugs||
4071|015|U|known as sulfa antibiotics. It works by stopping the growth of||
4071|016|U|bacteria and other organisms.||
4071|017|U|   This antibiotic treats only certain types of infections. It||
4071|018|U|will not work for viral infections (such as common cold, flu).||
4071|019|U|Unnecessary use or misuse of any antibiotic can lead to its||
4071|020|U|decreased effectiveness.||
4071|021|U|   This medication should not be used in infants younger than 2||
4071|022|U|months because of the risk of serious side effects, unless||
4071|023|U|treatment is for a very serious infection (congenital||
4071|024|U|toxoplasmosis).||
4071|025|B|||
4071|026|H|HOW TO USE:  Take this medication by mouth with a full glass of||
4071|027|H|water (8 ounces or 240 milliliters) as directed by your doctor.||
4071|028|H|Drink plenty of fluids during treatment with this medication||
4071|029|H|unless your doctor advises you otherwise. This will help prevent||
4071|030|H|unlikely side effects such as crystals appearing in the urine and||
4071|031|H|kidney stones.||
4071|032|H|   The dosage is based on your medical condition, weight, and||
4071|033|H|response to treatment.||
4071|034|H|   For the best effect, take this antibiotic at evenly spaced||
4071|035|H|times. To help you remember, take this medication at the same||
4071|036|H|time(s) every day.||
4071|037|H|   Continue to take this medication for the full time prescribed,||
4071|038|H|even if symptoms disappear after a few days. Stopping the||
4071|039|H|medication too early may result in a return of the infection.||
4071|040|H|   Tell your doctor if your condition lasts or gets worse.||
4071|041|B|||
4071|042|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, loss of appetite, or||
4071|043|S|headache may occur. If any of these effects last or get worse,||
4071|044|S|tell your doctor or pharmacist promptly.||
4071|045|S|   Remember that this medication has been prescribed because your||
4071|046|S|doctor has judged that the benefit to you is greater than the||
4071|047|S|risk of side effects. Many people using this medication do not||
4071|048|S|have serious side effects.||
4071|049|S|   Tell your doctor right away if you have any serious side||
4071|050|S|effects, including: mental/mood changes (such as depression,||
4071|051|S|hallucinations), signs of kidney problems (such as change in the||
4071|052|S|amount of urine, crystals in the urine, painful urination),||
4071|053|S|lump/growth/swelling in the front of the neck (goiter), signs of||
4071|054|S|low blood sugar (such as shaking, dizziness, blurred vision,||
4071|055|S|unusual hunger).||
4071|056|S|   This medication may rarely cause a severe intestinal condition||
4071|057|S|due to a bacteria called C. difficile. This condition may occur||
4071|058|S|during treatment or weeks to months after treatment has stopped.||
4071|059|S|Tell your doctor right away if you develop: diarrhea that doesn't||
4071|060|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
4071|061|S|stool.||
4071|062|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4071|063|S|products because they may make symptoms worse.||
4071|064|S|   Use of this medication for prolonged or repeated periods may||
4071|065|S|result in oral thrush or a new vaginal yeast infection. Contact||
4071|066|S|your doctor if you notice white patches in your mouth, a change||
4071|067|S|in vaginal discharge, or other new symptoms.||
4071|068|S|   Get medical help right away if you have any very serious side||
4071|069|S|effects, including: headache that is severe or doesn't go away,||
4071|070|S|confusion, neck stiffness, seizures.||
4071|071|S|   This medication may rarely cause serious (possibly fatal)||
4071|072|S|allergic reactions and other side effects such as a severe||
4071|073|S|peeling skin rash (such as Stevens-Johnson syndrome), blood||
4071|074|S|disorders (such as agranulocytosis, aplastic anemia), liver||
4071|075|S|damage, or lung injury. Get medical help right away if you notice||
4071|076|S|any of the following: cough that doesn't go away, nausea/vomiting||
4071|077|S|that doesn't stop, skin rash/blisters, itching/swelling||
4071|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4071|079|S|breathing, signs of a new infection (such as sore throat that||
4071|080|S|doesn't go away, fever), pale skin, easy bleeding/bruising,||
4071|081|S|yellowing eyes/skin, unusual tiredness, dark urine,||
4071|082|S|stomach/abdominal pain, joint pain.||
4071|083|S|   This is not a complete list of possible side effects. If you||
4071|084|S|notice other effects not listed above, contact your doctor or||
4071|085|S|pharmacist.||
4071|086|S|   In the US -||
4071|087|S|   Call your doctor for medical advice about side effects. You||
4071|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4071|089|S|www.fda.gov/medwatch.||
4071|090|S|   In Canada - Call your doctor for medical advice about side||
4071|091|S|effects. You may report side effects to Health Canada at||
4071|092|S|1-866-234-2345.||
4071|093|B|||
4071|094|P|PRECAUTIONS:  Before taking sulfadiazine, tell your doctor or||
4071|095|P|pharmacist if you are allergic to it; or to sulfa medications; or||
4071|096|P|if you have any other allergies. This product may contain||
4071|097|P|inactive ingredients, which can cause allergic reactions or other||
4071|098|P|problems. Talk to your pharmacist for more details.||
4071|099|P|   Before using this medication, tell your doctor or pharmacist||
4071|100|P|your medical history, especially of: certain metabolic disorders||
4071|101|P|(porphyria, G6PD deficiency), kidney disease, liver disease,||
4071|102|P|severe allergies, asthma, diabetes, blood disorders (such as||
4071|103|P|anemia due to folate vitamin deficiency), decreased bone marrow||
4071|104|P|function (bone marrow suppression).||
4071|105|P|   Sulfadiazine may cause live bacterial vaccines (such as||
4071|106|P|typhoid vaccine) to not work well. Tell your health care||
4071|107|P|professional that you are using sulfadiazine before having any||
4071|108|P|immunizations/vaccinations.||
4071|109|P|   This medication may make you more sensitive to the sun. Limit||
4071|110|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4071|111|P|sunscreen and wear protective clothing when outdoors. Get medical||
4071|112|P|help right away if you get sunburned or have skin||
4071|113|P|blisters/redness.||
4071|114|P|   Older adults may be more sensitive to the side effects of the||
4071|115|P|drug, especially skin reactions and blood disorders.||
4071|116|P|   During pregnancy, this medication should be used only when||
4071|117|P|clearly needed. This medication should not be used near the||
4071|118|P|expected delivery date because of possible harm to the unborn||
4071|119|P|baby. Discuss the risks and benefits with your doctor.||
4071|120|P|   This drug passes into breast milk. This drug may have||
4071|121|P|undesirable effects on infants who are ill or premature or have||
4071|122|P|certain disorders (jaundice, high blood levels of bilirubin, G6PD||
4071|123|P|deficiency). Breastfeeding is not recommended for infants with||
4071|124|P|these conditions. Consult your doctor before breastfeeding.||
4071|125|B|||
4071|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4071|127|I|medications work or increase your risk for serious side effects.||
4071|128|I|This document does not contain all possible drug interactions.||
4071|129|I|Keep a list of all the products you use (including||
4071|130|I|prescription/nonprescription drugs and herbal products) and share||
4071|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
4071|132|I|the dosage of any medicines without your doctor's approval.||
4071|133|I|   Some products that may interact with this drug include:||
4071|134|I|methenamine, methotrexate, PABA taken by mouth, warfarin.||
4071|135|B|||
4071|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4071|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4071|138|O|poison control center right away. US residents can call||
4071|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4071|140|O|Symptoms of overdose may include: dizziness, drowsiness, blood in||
4071|141|O|the urine, fever, loss of consciousness.||
4071|142|B|||
4071|143|N|NOTES:  Do not share this medication with others.||
4071|144|N|   This medication has been prescribed for your current condition||
4071|145|N|only. Do not use it later for another infection unless your||
4071|146|N|doctor tells you to.||
4071|147|N|   If you are using this medication for an extended period, lab||
4071|148|N|and/or medical tests (such as complete blood count, kidney||
4071|149|N|function) should be done while you are taking this medication.||
4071|150|N|Keep all medical and lab appointments. Consult your doctor for||
4071|151|N|more details.||
4071|152|B|||
4071|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4071|154|D|remember. If it is near the time of the next dose, skip the||
4071|155|D|missed dose. Take your next dose at the regular time. Do not||
4071|156|D|double the dose to catch up.||
4071|157|B|||
4071|158|R|STORAGE:  Store at room temperature away from light and moisture.||
4071|159|R|Do not store in the bathroom. Keep all medications away from||
4071|160|R|children and pets.||
4071|161|R|   Do not flush medications down the toilet or pour them into a||
4071|162|R|drain unless instructed to do so. Properly discard this product||
4071|163|R|when it is expired or no longer needed. Consult your pharmacist||
4071|164|R|or local waste disposal company.||
4071|165|B|||
4071|166|A|Information last revised January 2025.||
4071|167|A|Copyright(c) 2025 First Databank, Inc.||
4071|168|B|||
4072|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4072|002|Z|does NOT have all possible information about this product. This||
4072|003|Z|information does not assure that this product is safe, effective,||
4072|004|Z|or appropriate for you. This information is not individual||
4072|005|Z|medical advice and does not substitute for the advice of your||
4072|006|Z|health care professional. Always ask your health care||
4072|007|Z|professional for complete information about this product and your||
4072|008|Z|specific health needs.||
4072|009|B|||
4072|010|T|NEOMYCIN/POLYMYXIN/HYDROCORTISONE SUSPENSION - OPHTHALMIC/OTIC||
4072|011|F|(nee-oh-MY-sin/paw-lee-MIX-in/hi-dro-KORT-ih-sown)||
4072|012|B|||
4072|013|C|COMMON BRAND NAME(S): Cortisporin||
4072|014|B|||
4072|015|U|USES:  This medication is used to treat or prevent bacterial eye||
4072|016|U|infections. This product contains neomycin and polymyxin, which||
4072|017|U|are antibiotics that work by stopping the growth of bacteria. It||
4072|018|U|also contains hydrocortisone, which is an anti-inflammatory||
4072|019|U|corticosteroid that works by reducing swelling.||
4072|020|U|   This medication treats/prevents only bacterial eye infections.||
4072|021|U|It will not work for other types of eye infections. Unnecessary||
4072|022|U|use or overuse of any antibiotic can lead to its decreased||
4072|023|U|effectiveness.||
4072|024|B|||
4072|025|V|OTHER USES:  This section contains uses of this drug that are not||
4072|026|V|listed in the approved professional labeling for the drug but||
4072|027|V|that may be prescribed by your health care professional. Use this||
4072|028|V|drug for a condition that is listed in this section only if it||
4072|029|V|has been so prescribed by your health care professional.||
4072|030|V|   This drug may also be used for bacterial ear infections.||
4072|031|B|||
4072|032|H|HOW TO USE:  EYE: To apply eye drops, wash your hands first. To||
4072|033|H|avoid contamination, do not touch the dropper tip or let it touch||
4072|034|H|your eye or any other surface. Shake the bottle well before each||
4072|035|H|dose.||
4072|036|H|   Do not wear contact lenses while you are using this medicine.||
4072|037|H|Sterilize contact lenses according to manufacturer's directions||
4072|038|H|and check with your doctor before you begin using them again.||
4072|039|H|   Tilt your head back, look upward, and pull down the lower||
4072|040|H|eyelid to make a pouch. Hold the dropper directly over your eye||
4072|041|H|and place one drop into the pouch. Look downward and gently close||
4072|042|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
4072|043|H|your eye (near the nose) and apply gentle pressure. This will||
4072|044|H|prevent the medication from draining out. Try not to blink and do||
4072|045|H|not rub your eye. Repeat these steps for your other eye if so||
4072|046|H|directed and if your dose is for more than 1 drop. The dosage is||
4072|047|H|based on your medical condition and response to treatment.||
4072|048|H|   Do not rinse the dropper. Replace the dropper cap after each||
4072|049|H|use.||
4072|050|H|   If you are using another kind of eye medication (such as drops||
4072|051|H|or ointments), wait at least 5 minutes before applying other||
4072|052|H|medications. Use eye drops before eye ointments to allow the eye||
4072|053|H|drops to enter the eye.||
4072|054|H|   Wait several minutes for your vision to clear before driving||
4072|055|H|or operating machinery.||
4072|056|H|   Do not use this medication more often than prescribed or for||
4072|057|H|longer than 10 days unless directed by your doctor.||
4072|058|H|   EAR: Use this medication as directed by your doctor, usually 3||
4072|059|H|or 4 times a day. Do not use this medication more often than||
4072|060|H|prescribed or for longer than 10 days. The ear canal should be||
4072|061|H|clean and dry before using this medication.||
4072|062|H|   For accuracy and to avoid contamination, have another person||
4072|063|H|insert the drops if possible. Before using, hold the container in||
4072|064|H|your hand for a few minutes in order to warm it. This will||
4072|065|H|minimize dizziness.||
4072|066|H|   To apply ear drops, wash your hands first. To avoid||
4072|067|H|contamination, do not touch the dropper tip or let it touch your||
4072|068|H|ear or any other surface. Shake the container well before using.||
4072|069|H|   Lie on your side with the treated ear upward. Hold the dropper||
4072|070|H|directly over the ear and place the prescribed number of drops||
4072|071|H|into the ear canal. To help the drops roll into the ear of an||
4072|072|H|adult, hold the earlobe up and back. For children, hold the||
4072|073|H|earlobe down and back. Keep the head tilted with the treated ear||
4072|074|H|upward for 5 minutes, or insert a soft cotton plug if so||
4072|075|H|directed. Another way to give this medication is to place a||
4072|076|H|cotton wick in the ear canal and moisten it with the prescribed||
4072|077|H|number of drops as often as directed. The wick should be replaced||
4072|078|H|at least once a day.||
4072|079|H|   Repeat the above steps for the other ear if so directed. Do||
4072|080|H|not rinse the dropper. Replace the cap after use.||
4072|081|H|   Use this medication regularly in order to get the most benefit||
4072|082|H|from it. To help you remember, use it at the same times each day.||
4072|083|H|Continue to use this medication for the full time prescribed,||
4072|084|H|even if symptoms disappear after a few days. Stopping the||
4072|085|H|medication too early may result in a return of the infection.||
4072|086|H|   Tell your doctor if your condition does not get better after 2||
4072|087|H|days of treatment.||
4072|088|B|||
4072|089|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
4072|090|S|eye/ear for a minute or two when applied. If this effect lasts or||
4072|091|S|gets worsen, tell your doctor or pharmacist promptly.||
4072|092|S|   Remember that this medication has been prescribed because your||
4072|093|S|doctor has judged that the benefit to you is greater than the||
4072|094|S|risk of side effects. Many people using this medication do not||
4072|095|S|have serious side effects.||
4072|096|S|   Use of this medication for prolonged/repeated periods may||
4072|097|S|result in a new fungal eye/ear infection and may increase your||
4072|098|S|risk for other eye/ear problems (such as glaucoma, cataracts,||
4072|099|S|hearing loss). Do not use this medication for longer than||
4072|100|S|prescribed. Tell your doctor right away if any of these unlikely||
4072|101|S|but serious side effects occur: new or worsening eye/ear symptoms||
4072|102|S|(such as discharge, swelling, redness), vision/hearing problems,||
4072|103|S|eye pain.||
4072|104|S|   A very serious allergic reaction to this drug is rare.||
4072|105|S|However, get medical help right away if you notice any symptoms||
4072|106|S|of a serious allergic reaction, including: rash, itching/swelling||
4072|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4072|108|S|breathing.||
4072|109|S|   This is not a complete list of possible side effects. If you||
4072|110|S|notice other effects not listed above, contact your doctor or||
4072|111|S|pharmacist.||
4072|112|S|   In the US -||
4072|113|S|   Call your doctor for medical advice about side effects. You||
4072|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4072|115|S|www.fda.gov/medwatch.||
4072|116|S|   In Canada - Call your doctor for medical advice about side||
4072|117|S|effects. You may report side effects to Health Canada at||
4072|118|S|1-866-234-2345.||
4072|119|B|||
4072|120|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
4072|121|P|pharmacist if you are allergic to neomycin, polymyxin, or||
4072|122|P|hydrocortisone; or to aminoglycoside antibiotics (such as||
4072|123|P|gentamicin, tobramycin); or to corticosteroids (such as||
4072|124|P|dexamethasone, prednisone); or if you have any other allergies.||
4072|125|P|This product may contain inactive ingredients (such as||
4072|126|P|preservatives like benzalkonium chloride, thimerosal), which can||
4072|127|P|cause allergic reactions or other problems. Talk to your||
4072|128|P|pharmacist for more details.||
4072|129|P|   Before using this medication, tell your doctor or pharmacist||
4072|130|P|your medical history, especially of: other ear problems (such as||
4072|131|P|a hole in your eardrum, middle ear infection), an eye/ear||
4072|132|P|infection not caused by bacteria (such as viral, fungal,||
4072|133|P|mycobacterial), other eye problems (such as glaucoma).||
4072|134|P|   If you are using this medication to treat the eyes, your||
4072|135|P|vision may become temporarily blurred or unstable after applying.||
4072|136|P|Do not drive, use machinery, or do anything that needs clear||
4072|137|P|vision until you can do it safely.||
4072|138|P|   During pregnancy, this medication should be used only when||
4072|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
4072|140|P|   It is unknown if this drug passes into breast milk. Consult||
4072|141|P|your doctor before breastfeeding.||
4072|142|B|||
4072|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4072|144|I|medications work or increase your risk for serious side effects.||
4072|145|I|This document does not contain all possible drug interactions.||
4072|146|I|Keep a list of all the products you use (including||
4072|147|I|prescription/nonprescription drugs and herbal products) and share||
4072|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
4072|149|I|the dosage of any medicines without your doctor's approval.||
4072|150|B|||
4072|151|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
4072|152|O|has overdosed and has serious symptoms such as passing out or||
4072|153|O|trouble breathing, call 911. Otherwise, call a poison control||
4072|154|O|center right away. US residents can call 1-800-222-1222. Canada||
4072|155|O|residents can call 1-844-764-7669.||
4072|156|B|||
4072|157|N|NOTES:  Do not share this medication with others.||
4072|158|N|   This medication has been prescribed for your current condition||
4072|159|N|only. Throw away the unused medication after treatment is||
4072|160|N|completed. Do not use it later for another infection unless your||
4072|161|N|doctor tells you to.||
4072|162|N|   If you are using this medication to treat an eye infection,||
4072|163|N|and you use it for 10 days or longer, lab and/or medical tests||
4072|164|N|(such as eye exams) should be done while you are using this||
4072|165|N|medication. Keep all medical and lab appointments. Consult your||
4072|166|N|doctor for more details.||
4072|167|N|   If you are using this medication to treat an ear infection, it||
4072|168|N|is important to keep the infected ear(s) clean and dry. Try not||
4072|169|N|to get the infected ear(s) wet when bathing. Avoid swimming||
4072|170|N|unless your doctor tells you otherwise.||
4072|171|B|||
4072|172|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4072|173|D|If it is near the time of the next dose, skip the missed dose.||
4072|174|D|Use your next dose at the regular time. Do not double the dose to||
4072|175|D|catch up.||
4072|176|B|||
4072|177|R|STORAGE:  Store at room temperature. Keep all medications away||
4072|178|R|from children and pets.||
4072|179|R|   Do not flush medications down the toilet or pour them into a||
4072|180|R|drain unless instructed to do so. Properly discard this product||
4072|181|R|when it is expired or no longer needed. Consult your pharmacist||
4072|182|R|or local waste disposal company.||
4072|183|B|||
4072|184|A|Information last revised November 2024.||
4072|185|A|Copyright(c) 2025 First Databank, Inc.||
4072|186|B|||
4073|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4073|002|Z|does NOT have all possible information about this product. This||
4073|003|Z|information does not assure that this product is safe, effective,||
4073|004|Z|or appropriate for you. This information is not individual||
4073|005|Z|medical advice and does not substitute for the advice of your||
4073|006|Z|health care professional. Always ask your health care||
4073|007|Z|professional for complete information about this product and your||
4073|008|Z|specific health needs.||
4073|009|B|||
4073|010|T|DEMECLOCYCLINE - ORAL||
4073|011|F|(dem-eh-klo-SYE-kleen)||
4073|012|B|||
4073|013|C|COMMON BRAND NAME(S): Declomycin||
4073|014|B|||
4073|015|U|USES:  Demeclocycline is used to treat a wide variety of||
4073|016|U|bacterial infections, including those that cause acne. This||
4073|017|U|medication is known as a tetracycline antibiotic. It works by||
4073|018|U|stopping the growth of bacteria.||
4073|019|U|   This antibiotic treats only bacterial infections. It will not||
4073|020|U|work for viral infections (such as common cold, flu). Using any||
4073|021|U|antibiotic when it is not needed can cause it to not work for||
4073|022|U|future infections.||
4073|023|B|||
4073|024|V|OTHER USES:  This section contains uses of this drug that are not||
4073|025|V|listed in the approved professional labeling for the drug but||
4073|026|V|that may be prescribed by your health care professional. Use this||
4073|027|V|drug for a condition that is listed in this section only if it||
4073|028|V|has been so prescribed by your health care professional.||
4073|029|V|   This drug may also be used for a certain hormone imbalance||
4073|030|V|(Syndrome of Inappropriate Antidiuretic Hormone-SIADH) which||
4073|031|V|causes your body to retain water and your urine to be more||
4073|032|V|concentrated than it should be.||
4073|033|B|||
4073|034|H|HOW TO USE:  Take this medication by mouth on an empty stomach||
4073|035|H|(at least 1 hour before or 2 hours after a meal) as directed by||
4073|036|H|your doctor, usually 2 to 4 times a day. Take each dose with a||
4073|037|H|full glass of water (8 ounces or 240 milliliters) unless your||
4073|038|H|doctor directs you otherwise. Do not lie down for at least 10||
4073|039|H|minutes after taking this drug. For this reason, do not take it||
4073|040|H|right before bedtime.||
4073|041|H|   If stomach upset occurs, ask your doctor if you can take this||
4073|042|H|medication with food.||
4073|043|H|   Take this medication 2 to 3 hours before or after taking any||
4073|044|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
4073|045|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
4073|046|H|sucralfate, vitamins/minerals, dairy products (such as milk,||
4073|047|H|yogurt), and juice with added calcium. These products bind with||
4073|048|H|demeclocycline, preventing your body from fully absorbing the||
4073|049|H|drug.||
4073|050|H|   The dosage is based on your medical condition and response to||
4073|051|H|treatment. Children's dosage may also be based on weight.||
4073|052|H|   For the best effect, take this antibiotic at evenly spaced||
4073|053|H|times. To help you remember, take this medication at the same||
4073|054|H|time(s) every day.||
4073|055|H|   If you are taking this medication to treat an infection,||
4073|056|H|continue to take it until the full prescribed amount is finished,||
4073|057|H|even if symptoms disappear after a few days. Stopping the||
4073|058|H|medication too early may result in a return of the infection.||
4073|059|H|   Tell your doctor if your condition lasts or gets worse. If you||
4073|060|H|are using this medication to treat SIADH, you should notice an||
4073|061|H|increase in the amount of urine within 5 days.||
4073|062|B|||
4073|063|S|SIDE EFFECTS:  Diarrhea, loss of appetite, nausea, vomiting,||
4073|064|S|headache, dizziness, lightheadedness, or rectal discomfort may||
4073|065|S|occur. If any of these effects last or get worse, tell your||
4073|066|S|doctor or pharmacist promptly.||
4073|067|S|   Remember that this medication has been prescribed because your||
4073|068|S|doctor has judged that the benefit to you is greater than the||
4073|069|S|risk of side effects. Many people using this medication do not||
4073|070|S|have serious side effects.||
4073|071|S|   Tell your doctor right away if you have any serious side||
4073|072|S|effects, including: darkening of the skin and other areas of the||
4073|073|S|body (such as lips, inside of the mouth), difficult/painful||
4073|074|S|swallowing, unusual increase in the amount of urine (except for||
4073|075|S|the expected increase in urination if you are treating SIADH),||
4073|076|S|unusual decrease in the amount of urine or no urine, unusual||
4073|077|S|thirst, weakness, unusual tiredness, brown/gray tooth||
4073|078|S|discoloration, hearing changes (such as ringing in the ears,||
4073|079|S|decreased hearing), easy bruising/bleeding, new signs of||
4073|080|S|infection (such as sore throat that doesn't go away, fever,||
4073|081|S|chills), signs of liver disease (such as nausea/vomiting that||
4073|082|S|doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark||
4073|083|S|urine).||
4073|084|S|   Tetracycline drugs such as demeclocycline may rarely cause||
4073|085|S|increased pressure around the brain (intracranial||
4073|086|S|hypertension-IH). The risk of this side effect is greater for||
4073|087|S|women of childbearing age who are overweight or who have had IH||
4073|088|S|in the past. If IH develops, it usually goes away after||
4073|089|S|demeclocycline is stopped; however, there is a chance of||
4073|090|S|permanent vision loss or blindness. Get medical help right away||
4073|091|S|if you have: nausea/vomiting that doesn't stop, headache that is||
4073|092|S|severe or doesn't go away, vision changes (such as blurred/double||
4073|093|S|vision, decreased vision, sudden blindness).||
4073|094|S|   This medication may rarely cause a severe intestinal condition||
4073|095|S|due to a bacteria called C. difficile. This condition may occur||
4073|096|S|during treatment or weeks to months after treatment has stopped.||
4073|097|S|Tell your doctor right away if you develop: diarrhea that doesn't||
4073|098|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
4073|099|S|stool.||
4073|100|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4073|101|S|products because they may make symptoms worse.||
4073|102|S|   Use of this medication for prolonged or repeated periods may||
4073|103|S|result in oral thrush or a new vaginal yeast infection. Contact||
4073|104|S|your doctor if you notice white patches in your mouth, a change||
4073|105|S|in vaginal discharge, or other new symptoms.||
4073|106|S|   A very serious allergic reaction to this drug is rare.||
4073|107|S|However, get medical help right away if you notice any symptoms||
4073|108|S|of a serious allergic reaction, including: rash, skin||
4073|109|S|sores/blisters, itching/swelling (especially of the||
4073|110|S|face/tongue/throat), severe dizziness, trouble breathing, new or||
4073|111|S|worsening swelling/pain in the joints, chest pain, fast/irregular||
4073|112|S|heartbeat.||
4073|113|S|   This is not a complete list of possible side effects. If you||
4073|114|S|notice other effects not listed above, contact your doctor or||
4073|115|S|pharmacist.||
4073|116|S|   In the US -||
4073|117|S|   Call your doctor for medical advice about side effects. You||
4073|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4073|119|S|www.fda.gov/medwatch.||
4073|120|S|   In Canada - Call your doctor for medical advice about side||
4073|121|S|effects. You may report side effects to Health Canada at||
4073|122|S|1-866-234-2345.||
4073|123|B|||
4073|124|P|PRECAUTIONS:  See also Side Effects section.||
4073|125|P|   Before taking demeclocycline, tell your doctor or pharmacist||
4073|126|P|if you are allergic to it; or to other tetracycline medication||
4073|127|P|(such as doxycycline, minocycline, tetracycline); or if you have||
4073|128|P|any other allergies. This product may contain inactive||
4073|129|P|ingredients, which can cause allergic reactions or other||
4073|130|P|problems. Talk to your pharmacist for more details.||
4073|131|P|   Before using this medication, tell your doctor or pharmacist||
4073|132|P|your medical history, especially of: kidney disease, liver||
4073|133|P|disease, problems swallowing, esophagus problems (such as||
4073|134|P|esophageal ulcers, hiatal hernia, acid reflux disease-GERD),||
4073|135|P|lupus, a certain hormone imbalance called "water diabetes"||
4073|136|P|(diabetes insipidus).||
4073|137|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4073|138|P|can make you more dizzy. Do not drive, use machinery, or do||
4073|139|P|anything that needs alertness until you can do it safely. Limit||
4073|140|P|alcoholic beverages. Talk to your doctor if you are using||
4073|141|P|marijuana (cannabis).||
4073|142|P|   Demeclocycline may cause live bacterial vaccines (such as||
4073|143|P|typhoid vaccine) to not work well. Tell your health care||
4073|144|P|professional that you are using demeclocycline before having any||
4073|145|P|immunizations/vaccinations.||
4073|146|P|   This medication may make you more sensitive to the sun. Limit||
4073|147|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4073|148|P|sunscreen and wear protective clothing when outdoors. Get medical||
4073|149|P|help right away if you get sunburned or have skin||
4073|150|P|blisters/redness.||
4073|151|P|   Before having surgery, tell your doctor or dentist about all||
4073|152|P|the products you use (including prescription drugs,||
4073|153|P|nonprescription drugs, and herbal products).||
4073|154|P|   This medication should not be used by children younger than 8||
4073|155|P|years of age because it may cause permanent tooth discoloration||
4073|156|P|and other problems. Tooth discoloration has also occurred in||
4073|157|P|older children and young adults. Consult your doctor for more||
4073|158|P|information.||
4073|159|P|   Tell your doctor if you are pregnant or plan to become||
4073|160|P|pregnant. You should not become pregnant while using||
4073|161|P|demeclocycline. Demeclocycline may harm an unborn baby. If you||
4073|162|P|become pregnant, talk to your doctor right away about the risks||
4073|163|P|and benefits of this medication.||
4073|164|P|   This medication passes into breast milk. Consult your doctor||
4073|165|P|before breastfeeding.||
4073|166|B|||
4073|167|I|DRUG INTERACTIONS:  See also How to Use section.||
4073|168|I|   Drug interactions may change how your medications work or||
4073|169|I|increase your risk for serious side effects. This document does||
4073|170|I|not contain all possible drug interactions. Keep a list of all||
4073|171|I|the products you use (including prescription/nonprescription||
4073|172|I|drugs and herbal products) and share it with your doctor and||
4073|173|I|pharmacist. Do not start, stop, or change the dosage of any||
4073|174|I|medicines without your doctor's approval.||
4073|175|I|   Some products that may interact with this drug are: retinoid||
4073|176|I|medications taken by mouth (such as acitretin, isotretinoin),||
4073|177|I|strontium.||
4073|178|I|   This medication may interfere with certain lab tests (such as||
4073|179|I|some urine tests for sugar), possibly causing false test results.||
4073|180|I|Make sure lab personnel and all your doctors know you use this||
4073|181|I|drug.||
4073|182|B|||
4073|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4073|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4073|185|O|poison control center right away. US residents can call||
4073|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4073|187|B|||
4073|188|N|NOTES:  Do not share this medication with others.||
4073|189|N|   This medication has been prescribed for your current condition||
4073|190|N|only. Do not use it later for another infection unless your||
4073|191|N|doctor tells you to.||
4073|192|N|   With long-term use or if this medication is used to treat||
4073|193|N|SIADH, lab and/or medical tests (such as complete blood count,||
4073|194|N|kidney/liver function, mineral levels) should be done while you||
4073|195|N|are taking this medication. Keep all medical and lab||
4073|196|N|appointments. Consult your doctor for more details.||
4073|197|B|||
4073|198|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4073|199|D|remember. If it is near the time of the next dose, skip the||
4073|200|D|missed dose. Take your next dose at the regular time. Do not||
4073|201|D|double the dose to catch up.||
4073|202|B|||
4073|203|R|STORAGE:  Store at room temperature away from light and moisture.||
4073|204|R|Do not store in the bathroom. Keep all medications away from||
4073|205|R|children and pets.||
4073|206|R|   Do not flush medications down the toilet or pour them into a||
4073|207|R|drain unless instructed to do so. Properly discard this product||
4073|208|R|when it is expired or no longer needed. Taking outdated||
4073|209|R|demeclocycline can result in serious illness. Consult your||
4073|210|R|pharmacist or local waste disposal company.||
4073|211|B|||
4073|212|A|Information last revised September 2025.||
4073|213|A|Copyright(c) 2025 First Databank, Inc.||
4073|214|B|||
4075|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4075|002|Z|does NOT have all possible information about this product. This||
4075|003|Z|information does not assure that this product is safe, effective,||
4075|004|Z|or appropriate for you. This information is not individual||
4075|005|Z|medical advice and does not substitute for the advice of your||
4075|006|Z|health care professional. Always ask your health care||
4075|007|Z|professional for complete information about this product and your||
4075|008|Z|specific health needs.||
4075|009|B|||
4075|010|T|RAMIPRIL - ORAL||
4075|011|F|(RAM-ih-prill)||
4075|012|B|||
4075|013|C|COMMON BRAND NAME(S): Altace||
4075|014|B|||
4075|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
4075|016|W|unborn baby if used during pregnancy. It is important to prevent||
4075|017|W|pregnancy while taking this medication. Consult your doctor for||
4075|018|W|more details and to discuss the use of reliable forms of birth||
4075|019|W|control while taking this medication. If you are planning||
4075|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
4075|021|W|your doctor right away.||
4075|022|B|||
4075|023|U|USES:  Ramipril is used to treat high blood pressure||
4075|024|U|(hypertension). Lowering high blood pressure helps prevent||
4075|025|U|strokes, heart attacks, and kidney problems. Ramipril is also||
4075|026|U|used to improve survival after a heart attack. It may also be||
4075|027|U|used in high risk patients (such as patients with heart||
4075|028|U|disease/diabetes) to help prevent heart attacks and strokes. This||
4075|029|U|medication may also be used to treat heart failure in patients||
4075|030|U|who have had a recent heart attack.||
4075|031|U|   Ramipril is an ACE inhibitor and works by relaxing blood||
4075|032|U|vessels so that blood can flow more easily.||
4075|033|B|||
4075|034|V|OTHER USES:  This section contains uses of this drug that are not||
4075|035|V|listed in the approved professional labeling for the drug but||
4075|036|V|that may be prescribed by your health care professional. Use this||
4075|037|V|drug for a condition that is listed in this section only if it||
4075|038|V|has been so prescribed by your health care professional.||
4075|039|V|   This medication may also be used for kidney disease and to||
4075|040|V|help protect the kidneys from harm due to diabetes.||
4075|041|B|||
4075|042|H|HOW TO USE:  Take this medication by mouth with or without food||
4075|043|H|as directed by your doctor, usually once or twice daily. Swallow||
4075|044|H|the capsule whole.||
4075|045|H|   If you have difficulty swallowing the capsule, the capsule may||
4075|046|H|be opened and the contents sprinkled onto cool applesauce (about||
4075|047|H|4 ounces) or mixed in half a glass of water or apple juice (4||
4075|048|H|ounces/120 milliliters). Swallow or drink the whole mixture right||
4075|049|H|away (or within 24 hours of mixing if stored at room temperature||
4075|050|H|or within 48 hours if stored in the refrigerator).||
4075|051|H|   The dosage is based on your medical condition and response to||
4075|052|H|treatment.||
4075|053|H|   To reduce your risk of side effects, your doctor may direct||
4075|054|H|you to start this medication at a low dose and gradually increase||
4075|055|H|your dose. Follow your doctor's instructions carefully.||
4075|056|H|   Use this medication regularly in order to get the most benefit||
4075|057|H|from it. To help you remember, take it at the same time(s) each||
4075|058|H|day. Keep taking this medication even if you feel well. Most||
4075|059|H|people with high blood pressure do not feel sick.||
4075|060|H|   For the treatment of high blood pressure, it may take several||
4075|061|H|weeks before you get the full benefit of this medication. Tell||
4075|062|H|your doctor if your condition does not get better or if it gets||
4075|063|H|worse (for example, your blood pressure readings remain high or||
4075|064|H|increase).||
4075|065|B|||
4075|066|S|SIDE EFFECTS:  Dizziness, lightheadedness, or tiredness may occur||
4075|067|S|as your body adjusts to the medication. Dry cough may also occur.||
4075|068|S|If any of these effects last or get worse, tell your doctor or||
4075|069|S|pharmacist promptly.||
4075|070|S|   To reduce the risk of dizziness and lightheadedness, get up||
4075|071|S|slowly when rising from a sitting or lying position.||
4075|072|S|   Remember that this medication has been prescribed because your||
4075|073|S|doctor has judged that the benefit to you is greater than the||
4075|074|S|risk of side effects. Many people using this medication do not||
4075|075|S|have serious side effects.||
4075|076|S|   Tell your doctor right away if you have any serious side||
4075|077|S|effects, including: fainting, symptoms of a high potassium blood||
4075|078|S|level (such as muscle weakness, slow/irregular heartbeat).||
4075|079|S|   Although ramipril may be used to prevent kidney problems or||
4075|080|S|treat people who have kidney problems, it may also rarely cause||
4075|081|S|serious kidney problems or make them worse. Your doctor will||
4075|082|S|check your kidney function while you are taking ramipril. Tell||
4075|083|S|your doctor right away if you have any signs of kidney problems||
4075|084|S|such as a change in the amount of urine.||
4075|085|S|   This drug may rarely cause serious (possibly fatal) liver||
4075|086|S|problems. Get medical help right away if you have any symptoms of||
4075|087|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
4075|088|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
4075|089|S|urine.||
4075|090|S|   A very serious allergic reaction to this drug is rare.||
4075|091|S|However, get medical help right away if you notice any symptoms||
4075|092|S|of a serious allergic reaction, including: rash, itching/swelling||
4075|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4075|094|S|breathing.||
4075|095|S|   This is not a complete list of possible side effects. If you||
4075|096|S|notice other effects not listed above, contact your doctor or||
4075|097|S|pharmacist.||
4075|098|S|   In the US -||
4075|099|S|   Call your doctor for medical advice about side effects. You||
4075|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4075|101|S|www.fda.gov/medwatch.||
4075|102|S|   In Canada - Call your doctor for medical advice about side||
4075|103|S|effects. You may report side effects to Health Canada at||
4075|104|S|1-866-234-2345.||
4075|105|B|||
4075|106|P|PRECAUTIONS:  Before taking ramipril, tell your doctor or||
4075|107|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
4075|108|P|(such as benazepril); or if you have any other allergies. This||
4075|109|P|product may contain inactive ingredients, which can cause||
4075|110|P|allergic reactions or other problems. Talk to your pharmacist for||
4075|111|P|more details.||
4075|112|P|   Before using this medication, tell your doctor or pharmacist||
4075|113|P|your medical history, especially of: history of an allergic||
4075|114|P|reaction which included swelling of the face/lips/tongue/throat||
4075|115|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
4075|116|P|dialysis), high level of potassium in the blood.||
4075|117|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4075|118|P|can make you more dizzy. Do not drive, use machinery, or do||
4075|119|P|anything that needs alertness until you can do it safely. Limit||
4075|120|P|alcoholic beverages. Talk to your doctor if you are using||
4075|121|P|marijuana (cannabis).||
4075|122|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
4075|123|P|and cause you to feel lightheaded. Tell your doctor if you have||
4075|124|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
4075|125|P|of fluids unless your doctor tells you not to.||
4075|126|P|   Before having surgery, tell your doctor or dentist about all||
4075|127|P|the products you use (including prescription drugs,||
4075|128|P|nonprescription drugs, and herbal products).||
4075|129|P|   This product may increase your potassium levels. Before using||
4075|130|P|potassium supplements or salt substitutes that contain potassium,||
4075|131|P|consult your doctor or pharmacist.||
4075|132|P|   Older adults may be more sensitive to the side effects of this||
4075|133|P|drug, including dizziness and increases in potassium level.||
4075|134|P|   Tell your doctor if you are pregnant or plan to become||
4075|135|P|pregnant. You should not become pregnant while using ramipril.||
4075|136|P|Ramipril may harm an unborn baby. If you become pregnant, talk to||
4075|137|P|your doctor right away about the risks and benefits of this||
4075|138|P|medication. (See also Warning section.)||
4075|139|P|   It is unknown if this medication passes into breast milk.||
4075|140|P|Consult your doctor before breastfeeding.||
4075|141|B|||
4075|142|I|DRUG INTERACTIONS:  See also Precautions section.||
4075|143|I|   Drug interactions may change how your medications work or||
4075|144|I|increase your risk for serious side effects. This document does||
4075|145|I|not contain all possible drug interactions. Keep a list of all||
4075|146|I|the products you use (including prescription/nonprescription||
4075|147|I|drugs and herbal products) and share it with your doctor and||
4075|148|I|pharmacist. Do not start, stop, or change the dosage of any||
4075|149|I|medicines without your doctor's approval.||
4075|150|I|   Some products that may interact with this drug include:||
4075|151|I|aliskiren, certain drugs that weaken the immune system/increase||
4075|152|I|the risk of infection (such as everolimus, sirolimus), lithium,||
4075|153|I|drugs that may increase the level of potassium in the blood (such||
4075|154|I|as ARBs including losartan/valsartan, birth control pills||
4075|155|I|containing drospirenone), sacubitril, telmisartan.||
4075|156|I|   Some products have ingredients that could raise your blood||
4075|157|I|pressure or worsen your heart failure. Tell your pharmacist what||
4075|158|I|products you are using, and ask how to use them safely||
4075|159|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
4075|160|I|ibuprofen/naproxen).||
4075|161|I|   A very serious reaction may occur if you are getting||
4075|162|I|injections for bee/wasp sting allergy (desensitization) and are||
4075|163|I|also taking ramipril. Make sure all your doctors know which||
4075|164|I|medicines you are using.||
4075|165|B|||
4075|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4075|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4075|168|O|poison control center right away. US residents can call||
4075|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4075|170|O|Symptoms of overdose may include: severe dizziness, fainting.||
4075|171|B|||
4075|172|N|NOTES:  Do not share this medication with others.||
4075|173|N|   Lifestyle changes such as stress reduction programs, exercise||
4075|174|N|and dietary changes may increase the effectiveness of this||
4075|175|N|medicine. Talk to your doctor or pharmacist about lifestyle||
4075|176|N|changes that might benefit you.||
4075|177|N|   Lab and/or medical tests (such as kidney function, potassium||
4075|178|N|levels) should be done while you are taking this medication. Keep||
4075|179|N|all medical and lab appointments. Consult your doctor for more||
4075|180|N|details.||
4075|181|N|   Check your blood pressure regularly while taking this||
4075|182|N|medication. Learn how to monitor your own blood pressure at home,||
4075|183|N|and share the results with your doctor.||
4075|184|B|||
4075|185|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4075|186|D|remember. If it is near the time of the next dose, skip the||
4075|187|D|missed dose. Take your next dose at the regular time. Do not||
4075|188|D|double the dose to catch up.||
4075|189|B|||
4075|190|R|STORAGE:  Store at room temperature away from light and moisture.||
4075|191|R|Do not store in the bathroom. Keep all medications away from||
4075|192|R|children and pets.||
4075|193|R|   Do not flush medications down the toilet or pour them into a||
4075|194|R|drain unless instructed to do so. Properly discard this product||
4075|195|R|when it is expired or no longer needed. Consult your pharmacist||
4075|196|R|or local waste disposal company.||
4075|197|B|||
4075|198|A|Information last revised September 2024.||
4075|199|A|Copyright(c) 2025 First Databank, Inc.||
4075|200|B|||
4081|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4081|002|Z|does NOT have all possible information about this product. This||
4081|003|Z|information does not assure that this product is safe, effective,||
4081|004|Z|or appropriate for you. This information is not individual||
4081|005|Z|medical advice and does not substitute for the advice of your||
4081|006|Z|health care professional. Always ask your health care||
4081|007|Z|professional for complete information about this product and your||
4081|008|Z|specific health needs.||
4081|009|B|||
4081|010|T|BUTALBITAL/ACETAMINOPHEN - ORAL||
4081|011|F|(bue-TAL-bi-tal/a-SEET-a-MIN-oh-fen)||
4081|012|B|||
4081|013|C|COMMON BRAND NAME(S): Phrenilin||
4081|014|B|||
4081|015|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
4081|016|W|too much acetaminophen may cause serious (possibly fatal) liver||
4081|017|W|disease. Adults should not take more than 4000 milligrams (4||
4081|018|W|grams) of acetaminophen a day. People with liver problems and||
4081|019|W|children should take less acetaminophen. Ask your doctor or||
4081|020|W|pharmacist how much acetaminophen is safe to take.||
4081|021|W|   Do not use with any other drug containing acetaminophen||
4081|022|W|without asking your doctor or pharmacist first. Acetaminophen is||
4081|023|W|in many nonprescription and prescription medications (such as||
4081|024|W|pain/fever drugs or cough-and-cold products). Check the labels on||
4081|025|W|all your medicines to see if they contain acetaminophen, and ask||
4081|026|W|your pharmacist if you are unsure.||
4081|027|W|   Get medical help right away if you take too much acetaminophen||
4081|028|W|(overdose), even if you feel well. Overdose symptoms may include||
4081|029|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
4081|030|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
4081|031|W|   Daily alcohol use, especially when combined with||
4081|032|W|acetaminophen, may damage your liver. Avoid alcohol.||
4081|033|B|||
4081|034|U|USES:  This combination medication is used to treat tension||
4081|035|U|headaches. Acetaminophen helps to decrease the pain from the||
4081|036|U|headache. Butalbital is a sedative that helps to decrease anxiety||
4081|037|U|and cause sleepiness and relaxation.||
4081|038|B|||
4081|039|H|HOW TO USE:  See also Warning section.||
4081|040|H|   Take this medication by mouth with or without food as directed||
4081|041|H|by your doctor, usually every 4 hours as needed. Do not take more||
4081|042|H|than 300 milligrams of butalbital in a 24-hour period.||
4081|043|H|   The dosage is based on your medical condition and response to||
4081|044|H|treatment. This medication works best if it is used as the first||
4081|045|H|signs of a headache occur. If you wait until the headache has||
4081|046|H|worsened, the medication may not work as well.||
4081|047|H|   If you suddenly stop using this medication, you may have||
4081|048|H|withdrawal symptoms (such as nausea/vomiting, mental/mood||
4081|049|H|changes, seizures). To help prevent withdrawal, your doctor may||
4081|050|H|lower your dose slowly. Withdrawal is more likely if you have||
4081|051|H|used this medication for a long time or in high doses. Tell your||
4081|052|H|doctor or pharmacist right away if you have withdrawal.||
4081|053|H|   Though it helps many people, this medication may sometimes||
4081|054|H|cause addiction. This risk may be higher if you have a substance||
4081|055|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
4081|056|H|Do not increase your dose, take it more often, or use it for a||
4081|057|H|longer time than prescribed. Properly stop the medication when so||
4081|058|H|directed.||
4081|059|H|   Tell your doctor if you notice increased use of this||
4081|060|H|medication, a worsening of headaches, an increase in the number||
4081|061|H|of headaches, the medication not working as well, or use of this||
4081|062|H|medication for more than 2 headache episodes a week. Do not take||
4081|063|H|more than recommended. Your doctor may need to change your||
4081|064|H|medication and/or add a separate medication to prevent the||
4081|065|H|headaches.||
4081|066|B|||
4081|067|S|SIDE EFFECTS:  See also Warning section.||
4081|068|S|   Nausea, vomiting, abdominal pain, lightheadedness, dizziness,||
4081|069|S|or drowsiness may occur. If any of these effects last or get||
4081|070|S|worse, tell your doctor or pharmacist promptly.||
4081|071|S|   To reduce the risk of dizziness and lightheadedness, get up||
4081|072|S|slowly when rising from a sitting or lying position.||
4081|073|S|   Remember that this medication has been prescribed because your||
4081|074|S|doctor has judged that the benefit to you is greater than the||
4081|075|S|risk of side effects. Many people using this medication do not||
4081|076|S|have serious side effects.||
4081|077|S|   Tell your doctor right away if you have any serious side||
4081|078|S|effects, including: shortness of breath, mental/mood changes,||
4081|079|S|fainting, seizure, fast heartbeat, easy bruising/bleeding.||
4081|080|S|   A very serious allergic reaction to this drug is rare.||
4081|081|S|However, get medical help right away if you notice any symptoms||
4081|082|S|of a serious allergic reaction, including: rash, itching/swelling||
4081|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4081|084|S|breathing.||
4081|085|S|   This is not a complete list of possible side effects. If you||
4081|086|S|notice other effects not listed above, contact your doctor or||
4081|087|S|pharmacist.||
4081|088|S|   In the US -||
4081|089|S|   Call your doctor for medical advice about side effects. You||
4081|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4081|091|S|www.fda.gov/medwatch.||
4081|092|S|   In Canada - Call your doctor for medical advice about side||
4081|093|S|effects. You may report side effects to Health Canada at||
4081|094|S|1-866-234-2345.||
4081|095|B|||
4081|096|P|PRECAUTIONS:  See also Warning section.||
4081|097|P|   Before taking this medication, tell your doctor or pharmacist||
4081|098|P|if you are allergic to acetaminophen or butalbital; or to other||
4081|099|P|barbiturates (such as phenobarbital); or if you have any other||
4081|100|P|allergies. This product may contain inactive ingredients, which||
4081|101|P|can cause allergic reactions or other problems. Talk to your||
4081|102|P|pharmacist for more details.||
4081|103|P|   Before using this medication, tell your doctor or pharmacist||
4081|104|P|your medical history, especially of: breathing problems (such as||
4081|105|P|bronchopneumonia), a certain enzyme disorder (porphyria), liver||
4081|106|P|disease, kidney disease, personal or family history of a||
4081|107|P|substance use disorder (such as overuse of or addiction to||
4081|108|P|drugs/alcohol), mental/mood disorders, abdominal/intestinal||
4081|109|P|problems.||
4081|110|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4081|111|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4081|112|P|machinery, or do anything that needs alertness until you can do||
4081|113|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
4081|114|P|are using marijuana (cannabis).||
4081|115|P|   Before having surgery, tell your doctor or dentist about all||
4081|116|P|the products you use (including prescription drugs,||
4081|117|P|nonprescription drugs, and herbal products).||
4081|118|P|   Older adults may be more sensitive to the side effects of this||
4081|119|P|drug, especially drowsiness. This side effect can increase the||
4081|120|P|risk of falling.||
4081|121|P|   During pregnancy, this medication should be used only when||
4081|122|P|clearly needed. Using it for long periods or in high doses near||
4081|123|P|the expected delivery date is not recommended because of possible||
4081|124|P|harm to the unborn baby. Discuss the risks and benefits with your||
4081|125|P|doctor. Infants born to mothers who have used this medication for||
4081|126|P|an extended time may have withdrawal symptoms such as||
4081|127|P|irritability, abnormal/nonstop crying, vomiting, seizures, or||
4081|128|P|diarrhea. Tell your doctor right away if you notice any of these||
4081|129|P|symptoms in your newborn.||
4081|130|P|   This drug passes into breast milk and could have undesirable||
4081|131|P|effects on a nursing infant. Consult your doctor before||
4081|132|P|breastfeeding.||
4081|133|B|||
4081|134|I|DRUG INTERACTIONS:  See also Warning section.||
4081|135|I|   Drug interactions may change how your medications work or||
4081|136|I|increase your risk for serious side effects. This document does||
4081|137|I|not contain all possible drug interactions. Keep a list of all||
4081|138|I|the products you use (including prescription/nonprescription||
4081|139|I|drugs and herbal products) and share it with your doctor and||
4081|140|I|pharmacist. Do not start, stop, or change the dosage of any||
4081|141|I|medicines without your doctor's approval.||
4081|142|I|   Some products that may interact with this drug include:||
4081|143|I|darunavir, sodium oxybate, anti-seizure drugs (such as||
4081|144|I|phenytoin), isoniazid, ketoconazole, levoketoconazole,||
4081|145|I|phenothiazines (such as chlorpromazine).||
4081|146|I|   This drug can speed up the removal of other drugs from your||
4081|147|I|body, which may affect how they work. Examples of affected drugs||
4081|148|I|include doxycycline, estrogen, felodipine, lonafarnib, quinidine,||
4081|149|I|rilpivirine, tamoxifen, theophylline, voriconazole, "blood||
4081|150|I|thinners" (such as warfarin), certain beta blockers (such as||
4081|151|I|metoprolol), corticosteroids (such as prednisone), among others.||
4081|152|I|   Tell your doctor or pharmacist if you are taking other||
4081|153|I|products that cause drowsiness such as opioid pain or cough||
4081|154|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4081|155|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
4081|156|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4081|157|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
4081|158|I|diphenhydramine).||
4081|159|I|   Check the labels on all your medicines (such as allergy or||
4081|160|I|cough-and-cold products) because they may contain ingredients||
4081|161|I|that cause drowsiness. Ask your pharmacist about using those||
4081|162|I|products safely.||
4081|163|I|   This medication may decrease the effectiveness of hormonal||
4081|164|I|birth control such as pills, patch, or ring. This could cause||
4081|165|I|pregnancy. Discuss with your doctor or pharmacist if you should||
4081|166|I|use reliable backup birth control methods while using this||
4081|167|I|medication. Also tell your doctor if you have any new spotting or||
4081|168|I|breakthrough bleeding, because these may be signs that your birth||
4081|169|I|control is not working well.||
4081|170|I|   This medication may interfere with certain lab tests (such as||
4081|171|I|urine 5-HIAA levels), possibly causing false test results. Make||
4081|172|I|sure lab personnel and all your doctors know you use this drug.||
4081|173|B|||
4081|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4081|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4081|176|O|poison control center right away. US residents can call||
4081|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4081|178|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
4081|179|O|slow/shallow breathing, nausea, vomiting, loss of appetite,||
4081|180|O|sweating, stomach/abdominal pain, extreme tiredness, yellowing||
4081|181|O|eyes/skin, dark urine.||
4081|182|B|||
4081|183|N|NOTES:  Do not share this medication with others.||
4081|184|N|   Massage, hot baths, and other relaxation methods can help with||
4081|185|N|tension headaches. Consult your doctor or pharmacist for more||
4081|186|N|details.||
4081|187|N|   Lab and/or medical tests (such as liver/kidney function) may||
4081|188|N|be done while you are taking this medication. Keep all medical||
4081|189|N|and lab appointments. Consult your doctor for more details.||
4081|190|B|||
4081|191|D|MISSED DOSE:  Not applicable.||
4081|192|B|||
4081|193|R|STORAGE:  Store at room temperature away from light and moisture.||
4081|194|R|Do not store in the bathroom. Keep all medications away from||
4081|195|R|children and pets.||
4081|196|R|   Do not flush medications down the toilet or pour them into a||
4081|197|R|drain unless instructed to do so. Properly discard this product||
4081|198|R|when it is expired or no longer needed. Consult your pharmacist||
4081|199|R|or local waste disposal company.||
4081|200|B|||
4081|201|A|Information last revised May 2025.||
4081|202|A|Copyright(c) 2025 First Databank, Inc.||
4081|203|B|||
4087|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4087|002|Z|does NOT have all possible information about this product. This||
4087|003|Z|information does not assure that this product is safe, effective,||
4087|004|Z|or appropriate for you. This information is not individual||
4087|005|Z|medical advice and does not substitute for the advice of your||
4087|006|Z|health care professional. Always ask your health care||
4087|007|Z|professional for complete information about this product and your||
4087|008|Z|specific health needs.||
4087|009|B|||
4087|010|T|CARISOPRODOL - ORAL||
4087|011|F|(kar-iss-oh-PRO-dole)||
4087|012|B|||
4087|013|C|COMMON BRAND NAME(S): Soma||
4087|014|B|||
4087|015|U|USES:  Carisoprodol is used short-term to treat muscle pain and||
4087|016|U|discomfort. It is usually used along with rest, physical therapy,||
4087|017|U|and other treatments. It works by helping to relax the muscles.||
4087|018|B|||
4087|019|H|HOW TO USE:  Take this medication by mouth with or without food||
4087|020|H|as directed by your doctor. Do not increase your dose or use this||
4087|021|H|drug more often or for longer than prescribed. Your condition||
4087|022|H|will not improve any faster, and your risk of side effects will||
4087|023|H|increase.||
4087|024|H|   The dosage is based on your medical condition and response to||
4087|025|H|treatment. This medication should only be used short-term (for 3||
4087|026|H|weeks or less) unless directed by your doctor.||
4087|027|H|   If you suddenly stop using this medication, you may have||
4087|028|H|withdrawal symptoms (such as stomach cramps, trouble sleeping,||
4087|029|H|headache, nausea). To help prevent withdrawal, your doctor may||
4087|030|H|lower your dose slowly. Withdrawal is more likely if you have||
4087|031|H|used carisoprodol for a long time or in high doses. Tell your||
4087|032|H|doctor or pharmacist right away if you have withdrawal.||
4087|033|H|   Though it helps many people, this medication may sometimes||
4087|034|H|cause addiction. This risk may be higher if you have a substance||
4087|035|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
4087|036|H|Take this medication exactly as prescribed to lower the risk of||
4087|037|H|addiction. Ask your doctor or pharmacist for more details.||
4087|038|H|   Tell your doctor if your condition lasts after 2 to 3 weeks or||
4087|039|H|if it gets worse.||
4087|040|B|||
4087|041|S|SIDE EFFECTS:  Dizziness, drowsiness, or headache may occur. If||
4087|042|S|any of these effects last or get worse, tell your doctor or||
4087|043|S|pharmacist promptly.||
4087|044|S|   Remember that this medication has been prescribed because your||
4087|045|S|doctor has judged that the benefit to you is greater than the||
4087|046|S|risk of side effects. Many people using this medication do not||
4087|047|S|have serious side effects.||
4087|048|S|   Tell your doctor right away if you have any serious side||
4087|049|S|effects, including: confusion.||
4087|050|S|   A very serious allergic reaction to this drug is rare.||
4087|051|S|However, get medical help right away if you notice any symptoms||
4087|052|S|of a serious allergic reaction, including: rash, itching/swelling||
4087|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4087|054|S|breathing.||
4087|055|S|   This is not a complete list of possible side effects. If you||
4087|056|S|notice other effects not listed above, contact your doctor or||
4087|057|S|pharmacist.||
4087|058|S|   In the US -||
4087|059|S|   Call your doctor for medical advice about side effects. You||
4087|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4087|061|S|www.fda.gov/medwatch.||
4087|062|S|   In Canada - Call your doctor for medical advice about side||
4087|063|S|effects. You may report side effects to Health Canada at||
4087|064|S|1-866-234-2345.||
4087|065|B|||
4087|066|P|PRECAUTIONS:  Before taking carisoprodol, tell your doctor or||
4087|067|P|pharmacist if you are allergic to it; or to meprobamate,||
4087|068|P|tybamate, or mebutamate; or if you have any other allergies. This||
4087|069|P|product may contain inactive ingredients, which can cause||
4087|070|P|allergic reactions or other problems. Talk to your pharmacist for||
4087|071|P|more details.||
4087|072|P|   Before using this medication, tell your doctor or pharmacist||
4087|073|P|your medical history, especially of: a certain blood disorder||
4087|074|P|(acute intermittent porphyria), kidney disease, liver disease,||
4087|075|P|seizure, personal or family history of a substance use disorder||
4087|076|P|(such as overuse of or addiction to drugs/alcohol).||
4087|077|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4087|078|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4087|079|P|machinery, or do anything that needs alertness until you can do||
4087|080|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
4087|081|P|are using marijuana (cannabis).||
4087|082|P|   Before having surgery, tell your doctor or dentist about all||
4087|083|P|the products you use (including prescription drugs,||
4087|084|P|nonprescription drugs, and herbal products).||
4087|085|P|   Older adults may be more sensitive to the side effects of this||
4087|086|P|drug, especially drowsiness, or confusion. These side effects can||
4087|087|P|increase the risk of falling.||
4087|088|P|   During pregnancy, this medication should be used only when||
4087|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
4087|090|P|   This medication passes into breast milk and may have||
4087|091|P|undesirable effects on a nursing infant. Consult your doctor||
4087|092|P|before breastfeeding.||
4087|093|B|||
4087|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4087|095|I|medications work or increase your risk for serious side effects.||
4087|096|I|This document does not contain all possible drug interactions.||
4087|097|I|Keep a list of all the products you use (including||
4087|098|I|prescription/nonprescription drugs and herbal products) and share||
4087|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
4087|100|I|the dosage of any medicines without your doctor's approval.||
4087|101|I|   Tell your doctor or pharmacist if you are taking other||
4087|102|I|products that cause drowsiness such as opioid pain or cough||
4087|103|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4087|104|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4087|105|I|lorazepam, zolpidem), other muscle relaxants (such as||
4087|106|I|cyclobenzaprine, methocarbamol), or antihistamines (such as||
4087|107|I|cetirizine, diphenhydramine).||
4087|108|I|   Check the labels on all your medicines (such as allergy or||
4087|109|I|cough-and-cold products) because they may contain ingredients||
4087|110|I|that cause drowsiness. Ask your pharmacist about using those||
4087|111|I|products safely.||
4087|112|B|||
4087|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4087|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4087|115|O|poison control center right away. US residents can call||
4087|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4087|117|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
4087|118|O|seizures, slow/shallow breathing, mental/mood changes (such as||
4087|119|O|confusion, hallucinations), inability to move your legs/arms,||
4087|120|O|shaky/unsteady movement, vision changes (such as blurred vision).||
4087|121|B|||
4087|122|N|NOTES:  Do not share this medication with others. Sharing it is||
4087|123|N|against the law.||
4087|124|N|   This medication has been prescribed for your current condition||
4087|125|N|only. Do not use it later for another condition unless your||
4087|126|N|doctor directs you to do so. A different medication may be||
4087|127|N|necessary in that case.||
4087|128|B|||
4087|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4087|130|D|remember. If it is near the time of the next dose, skip the||
4087|131|D|missed dose. Take your next dose at the regular time. Do not||
4087|132|D|double the dose to catch up.||
4087|133|B|||
4087|134|R|STORAGE:  Store at room temperature away from light and moisture.||
4087|135|R|Do not store in the bathroom. Keep all medications away from||
4087|136|R|children and pets.||
4087|137|R|   Do not flush medications down the toilet or pour them into a||
4087|138|R|drain unless instructed to do so. Properly discard this product||
4087|139|R|when it is expired or no longer needed. Consult your pharmacist||
4087|140|R|or local waste disposal company.||
4087|141|B|||
4087|142|A|Information last revised May 2024.||
4087|143|A|Copyright(c) 2025 First Databank, Inc.||
4087|144|B|||
4092|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4092|002|Z|does NOT have all possible information about this product. This||
4092|003|Z|information does not assure that this product is safe, effective,||
4092|004|Z|or appropriate for you. This information is not individual||
4092|005|Z|medical advice and does not substitute for the advice of your||
4092|006|Z|health care professional. Always ask your health care||
4092|007|Z|professional for complete information about this product and your||
4092|008|Z|specific health needs.||
4092|009|B|||
4092|010|T|FENOFIBRATE - ORAL||
4092|011|F|(fen-oh-FYE-brate)||
4092|012|B|||
4092|013|C|COMMON BRAND NAME(S): Tricor, Triglide||
4092|014|B|||
4092|015|U|USES:  Fenofibrate is used along with a proper diet to help lower||
4092|016|U|"bad" cholesterol and fats (such as LDL, triglycerides) and raise||
4092|017|U|"good" cholesterol (HDL) in the blood. It works by increasing the||
4092|018|U|natural substance (enzyme) that breaks down fats in the blood.||
4092|019|U|Fenofibrate belongs to a group of drugs known as "fibrates."||
4092|020|U|Lowering triglycerides in people with very high triglyceride||
4092|021|U|blood levels may decrease the risk of pancreas disease||
4092|022|U|(pancreatitis). However, fenofibrate might not lower your risk of||
4092|023|U|a heart attack or stroke. Talk to your doctor about the risks and||
4092|024|U|benefits of fenofibrate.||
4092|025|U|   In addition to eating a proper diet (such as a||
4092|026|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
4092|027|U|help this medication work better include exercising, losing||
4092|028|U|weight if overweight, and stopping smoking. Consult your doctor||
4092|029|U|for more details.||
4092|030|B|||
4092|031|H|HOW TO USE:  Take this medication by mouth as directed by your||
4092|032|H|doctor, usually once daily. The manufacturer directs to swallow||
4092|033|H|this medication whole. However, many similar drugs||
4092|034|H|(immediate-release capsules/tablets) can be crushed/chewed.||
4092|035|H|Follow your doctor's directions on how to take this medication.||
4092|036|H|   Fenofibrate comes in different types of capsules and tablets||
4092|037|H|which provide different amounts of the medication. Do not switch||
4092|038|H|between different forms or brands of this medication unless||
4092|039|H|directed by your doctor. Some forms of this drug should be taken||
4092|040|H|with food but others may be taken with or without food. Ask your||
4092|041|H|pharmacist about your brand of fenofibrate. It is important to||
4092|042|H|take this medication correctly so that the drug has the greatest||
4092|043|H|benefit.||
4092|044|H|   The dosage is based on your medical condition and response to||
4092|045|H|treatment.||
4092|046|H|   If you are also taking certain other drugs to lower your||
4092|047|H|cholesterol (bile acid-binding resins such as cholestyramine or||
4092|048|H|colestipol), take fenofibrate at least 1 hour before or at least||
4092|049|H|4 to 6 hours after taking these medications. These medications||
4092|050|H|can bind to fenofibrate, preventing your body from fully||
4092|051|H|absorbing the drug.||
4092|052|H|   Take this medication regularly to get the most benefit from||
4092|053|H|it. To help you remember, take it at the same time each day. Do||
4092|054|H|not increase your dose or use this drug more often or for longer||
4092|055|H|than prescribed. Your cholesterol/triglycerides level will not||
4092|056|H|lower faster, and your risk of side effects will increase. Keep||
4092|057|H|taking this medication even if you feel well. Most people with||
4092|058|H|high cholesterol/triglycerides do not feel sick.||
4092|059|H|   It is very important to continue to follow your doctor's||
4092|060|H|advice about diet and exercise. It may take up to 2 months before||
4092|061|H|you get the full benefit of this medication.||
4092|062|B|||
4092|063|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
4092|064|S|because your doctor has judged that the benefit to you is greater||
4092|065|S|than the risk of side effects. Many people using this medication||
4092|066|S|do not have serious side effects.||
4092|067|S|   This medication may rarely cause gallstones and liver||
4092|068|S|problems. If you notice any of the following unlikely but serious||
4092|069|S|side effects, tell your doctor right away: nausea/vomiting that||
4092|070|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
4092|071|S|eyes/skin, dark urine.||
4092|072|S|   This drug may rarely cause muscle problems (which can rarely||
4092|073|S|lead to a very serious condition called rhabdomyolysis). Tell||
4092|074|S|your doctor right away if you develop any of these symptoms:||
4092|075|S|muscle pain/tenderness/weakness (especially with fever or unusual||
4092|076|S|tiredness), signs of kidney problems (such as change in the||
4092|077|S|amount of urine).||
4092|078|S|   Rarely, this medication has caused severe lowering of HDL||
4092|079|S|("good" cholesterol) levels. This is the opposite of what should||
4092|080|S|happen to your HDL levels (paradoxical reaction). Your HDL||
4092|081|S|cholesterol levels should be checked regularly. Keep all of your||
4092|082|S|lab appointments.||
4092|083|S|   Tell your doctor right away if you have any serious side||
4092|084|S|effects, including: easy bleeding/bruising, unusual tiredness.||
4092|085|S|   Get medical help right away if you have any very serious side||
4092|086|S|effects, including: chest pain, sudden pain/redness/swelling||
4092|087|S|usually in the leg, signs of infection (such as sore throat that||
4092|088|S|doesn't go away, fever, swollen lymph nodes, chills).||
4092|089|S|   A very serious allergic reaction to this drug is rare.||
4092|090|S|However, get medical help right away if you notice any symptoms||
4092|091|S|of a serious allergic reaction, including: rash, itching/swelling||
4092|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4092|093|S|breathing.||
4092|094|S|   This is not a complete list of possible side effects. If you||
4092|095|S|notice other effects not listed above, contact your doctor or||
4092|096|S|pharmacist.||
4092|097|S|   In the US -||
4092|098|S|   Call your doctor for medical advice about side effects. You||
4092|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4092|100|S|www.fda.gov/medwatch.||
4092|101|S|   In Canada - Call your doctor for medical advice about side||
4092|102|S|effects. You may report side effects to Health Canada at||
4092|103|S|1-866-234-2345.||
4092|104|B|||
4092|105|P|PRECAUTIONS:  Before taking fenofibrate, tell your doctor or||
4092|106|P|pharmacist if you are allergic to it; or to other "fibrates"||
4092|107|P|(such as fenofibric acid); or if you have any other allergies.||
4092|108|P|This product may contain inactive ingredients (such as soy),||
4092|109|P|which can cause allergic reactions or other problems. Talk to||
4092|110|P|your pharmacist for more details.||
4092|111|P|   Before using this medication, tell your doctor or pharmacist||
4092|112|P|your medical history, especially of: kidney disease, gallbladder||
4092|113|P|disease, liver disease (such as biliary cholangitis, hepatitis),||
4092|114|P|alcohol use.||
4092|115|P|   Before having surgery, tell your doctor or dentist about all||
4092|116|P|the products you use (including prescription drugs,||
4092|117|P|nonprescription drugs, and herbal products).||
4092|118|P|   Older adults may be more sensitive to the side effects of this||
4092|119|P|drug, especially muscle problems.||
4092|120|P|   During pregnancy, this medication should be used only when||
4092|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
4092|122|P|   It is unknown if this medication passes into breast milk.||
4092|123|P|Because of the possible risk to the infant, breastfeeding is not||
4092|124|P|recommended while using this medication and for 5 days after the||
4092|125|P|last dose. Consult your doctor before breastfeeding.||
4092|126|B|||
4092|127|I|DRUG INTERACTIONS:  See also How to Use section.||
4092|128|I|   Drug interactions may change how your medications work or||
4092|129|I|increase your risk for serious side effects. This document does||
4092|130|I|not contain all possible drug interactions. Keep a list of all||
4092|131|I|the products you use (including prescription/nonprescription||
4092|132|I|drugs and herbal products) and share it with your doctor and||
4092|133|I|pharmacist. Do not start, stop, or change the dosage of any||
4092|134|I|medicines without your doctor's approval.||
4092|135|I|   Some products that may interact with this drug include: "blood||
4092|136|I|thinners" (such as warfarin).||
4092|137|I|   Fenofibrate is very similar to fenofibric acid. Do not use||
4092|138|I|medications containing fenofibric acid while using fenofibrate.||
4092|139|B|||
4092|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4092|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4092|142|O|poison control center right away. US residents can call||
4092|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4092|144|B|||
4092|145|N|NOTES:  Do not share this medication with others.||
4092|146|N|   Lab and/or medical tests (such as cholesterol/triglyceride||
4092|147|N|levels, kidney/liver function, complete blood count) should be||
4092|148|N|done while you are taking this medication. Keep all medical and||
4092|149|N|lab appointments. Consult your doctor for more details. (See also||
4092|150|N|Side Effects section.)||
4092|151|B|||
4092|152|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
4092|153|D|next dose at the regular time. Do not double the dose to catch||
4092|154|D|up.||
4092|155|B|||
4092|156|R|STORAGE:  Store at room temperature away from light and moisture.||
4092|157|R|Different brands of this medication have different storage needs.||
4092|158|R|Check the product package for instructions on how to store your||
4092|159|R|brand, or ask your pharmacist. Do not store in the bathroom. Keep||
4092|160|R|all medications away from children and pets.||
4092|161|R|   Do not flush medications down the toilet or pour them into a||
4092|162|R|drain unless instructed to do so. Properly discard this product||
4092|163|R|when it is expired or no longer needed. Consult your pharmacist||
4092|164|R|or local waste disposal company.||
4092|165|B|||
4092|166|A|Information last revised June 2025.||
4092|167|A|Copyright(c) 2025 First Databank, Inc.||
4092|168|B|||
4094|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4094|002|Z|does NOT have all possible information about this product. This||
4094|003|Z|information does not assure that this product is safe, effective,||
4094|004|Z|or appropriate for you. This information is not individual||
4094|005|Z|medical advice and does not substitute for the advice of your||
4094|006|Z|health care professional. Always ask your health care||
4094|007|Z|professional for complete information about this product and your||
4094|008|Z|specific health needs.||
4094|009|B|||
4094|010|T|METHYLPHENIDATE SUSTAINED-ACTION LA - ORAL||
4094|011|F|(METH-il-FEN-i-date)||
4094|012|B|||
4094|013|C|COMMON BRAND NAME(S): Ritalin LA||
4094|014|B|||
4094|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
4094|016|W|serious (possibly fatal) heart and blood pressure problems.||
4094|017|W|   This medication can be habit-forming and should be used||
4094|018|W|cautiously by people who have mental/mood disorders or a||
4094|019|W|substance use disorder (such as overuse of or addiction to||
4094|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
4094|021|W|you have a personal or family history of a substance use||
4094|022|W|disorder. Do not increase your dose, use it more often, or use it||
4094|023|W|for a longer time or in a different way than prescribed. Doing so||
4094|024|W|may result in a decrease in the effect of this drug, drug||
4094|025|W|dependence, or abnormal thoughts/behavior.||
4094|026|W|   Your doctor may monitor you for a while after the medication||
4094|027|W|is stopped, especially if you have taken this drug for a long||
4094|028|W|time or in high doses. (See also How to Use section.)||
4094|029|B|||
4094|030|U|USES:  This medication is used to treat attention deficit||
4094|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
4094|032|U|of certain natural substances in the brain. Methylphenidate||
4094|033|U|belongs to a class of drugs known as stimulants. It can help||
4094|034|U|increase your ability to pay attention, stay focused on an||
4094|035|U|activity, and control behavior problems. It may also help you to||
4094|036|U|organize your tasks and improve listening skills.||
4094|037|B|||
4094|038|V|OTHER USES:  This section contains uses of this drug that are not||
4094|039|V|listed in the approved professional labeling for the drug but||
4094|040|V|that may be prescribed by your health care professional. Use this||
4094|041|V|drug for a condition that is listed in this section only if it||
4094|042|V|has been so prescribed by your health care professional.||
4094|043|V|   This drug may also be used for a certain sleep disorder||
4094|044|V|(narcolepsy).||
4094|045|B|||
4094|046|H|HOW TO USE:  Read the Medication Guide provided by your||
4094|047|H|pharmacist before you start taking methylphenidate and each time||
4094|048|H|you get a refill. If you have any questions, ask your doctor or||
4094|049|H|pharmacist.||
4094|050|H|   There are different brands and forms of this medication||
4094|051|H|available. They may not have the same effects and may not be||
4094|052|H|interchangeable. Do not change brands or forms without consulting||
4094|053|H|your doctor or pharmacist.||
4094|054|H|   Take this medication by mouth as directed by your doctor,||
4094|055|H|usually once daily before or with breakfast. If you have upset||
4094|056|H|stomach, you may take this medication with food. Taking this||
4094|057|H|medication late in the day may cause trouble sleeping (insomnia).||
4094|058|H|   Do not break, crush, or chew this medication. Doing so can||
4094|059|H|release all of the drug at once, increasing the risk of side||
4094|060|H|effects. Swallow the capsules whole. If you have trouble||
4094|061|H|swallowing the capsule, you may open the capsule and carefully||
4094|062|H|sprinkle its contents on a spoonful of cool applesauce. Swallow||
4094|063|H|all of the mixture right away without chewing it. Then drink a||
4094|064|H|glass of cool liquid to make sure you have swallowed all of the||
4094|065|H|dose. Do not prepare the mixture ahead of time.||
4094|066|H|   Do not drink alcoholic beverages while you are taking this||
4094|067|H|medication. Drinking alcohol may increase the amount of this||
4094|068|H|medication in your body which may cause serious side effects.||
4094|069|H|   Take this medication regularly to get the most benefit from||
4094|070|H|it. To help you remember, take it at the same time each day.||
4094|071|H|   The dosage is based on your medical condition and response to||
4094|072|H|treatment. Your doctor may direct you to gradually increase or||
4094|073|H|decrease your dose. Also, if you have used it for a long time, do||
4094|074|H|not suddenly stop using this drug without consulting your doctor.||
4094|075|H|   If you suddenly stop using this medication, you may have||
4094|076|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
4094|077|H|other mental/mood changes). To help prevent withdrawal, your||
4094|078|H|doctor may lower your dose slowly. Withdrawal is more likely if||
4094|079|H|you have used methylphenidate for a long time or in high doses.||
4094|080|H|Tell your doctor or pharmacist right away if you have withdrawal.||
4094|081|H|   When used for a long time, this medication may not work as||
4094|082|H|well. Talk with your doctor if this medication stops working||
4094|083|H|well.||
4094|084|H|   Though it helps many people, this medication may sometimes||
4094|085|H|cause addiction. This risk may be higher if you have a substance||
4094|086|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
4094|087|H|Take this medication exactly as prescribed to lower the risk of||
4094|088|H|addiction. Ask your doctor or pharmacist for more details.||
4094|089|H|   Tell your doctor if your condition does not get better or if||
4094|090|H|it gets worse.||
4094|091|B|||
4094|092|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
4094|093|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
4094|094|S|If any of these effects last or get worse, tell your doctor or||
4094|095|S|pharmacist promptly.||
4094|096|S|   Remember that this medication has been prescribed because your||
4094|097|S|doctor has judged that the benefit to you is greater than the||
4094|098|S|risk of side effects. Many people using this medication do not||
4094|099|S|have serious side effects.||
4094|100|S|   This medication may raise your blood pressure. Check your||
4094|101|S|blood pressure regularly and tell your doctor if the results are||
4094|102|S|high.||
4094|103|S|   Tell your doctor right away if you have any serious side||
4094|104|S|effects, including: signs of blood flow problems in the fingers||
4094|105|S|or toes (such as coldness, numbness, pain, or skin color||
4094|106|S|changes), unusual wounds on the fingers or toes,||
4094|107|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
4094|108|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
4094|109|S|thoughts of suicide), uncontrolled muscle movements (such as||
4094|110|S|twitching, shaking), sudden outbursts of words/sounds that are||
4094|111|S|hard to control, vision changes (such as blurred vision), slow||
4094|112|S|healing sores/ulcers on the tips of fingers/toes.||
4094|113|S|   Get medical help right away if you have any very serious side||
4094|114|S|effects, including: fainting, seizure, symptoms of a heart attack||
4094|115|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
4094|116|S|sweating), symptoms of a stroke (such as weakness on one side of||
4094|117|S|the body, trouble speaking, sudden vision changes, confusion).||
4094|118|S|   Rarely, males (including young boys and teens) may have a||
4094|119|S|painful or prolonged erection lasting 4 or more hours while using||
4094|120|S|this medication. Caregivers/parents should also be watchful for||
4094|121|S|this serious side effect in boys. If a painful or prolonged||
4094|122|S|erection occurs, stop using this drug and get medical help right||
4094|123|S|away, or permanent problems could occur. Ask your doctor or||
4094|124|S|pharmacist for more details.||
4094|125|S|   A very serious allergic reaction to this drug is rare.||
4094|126|S|However, get medical help right away if you notice any symptoms||
4094|127|S|of a serious allergic reaction, including: rash, itching/swelling||
4094|128|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4094|129|S|breathing.||
4094|130|S|   This is not a complete list of possible side effects. If you||
4094|131|S|notice other effects not listed above, contact your doctor or||
4094|132|S|pharmacist.||
4094|133|S|   In the US -||
4094|134|S|   Call your doctor for medical advice about side effects. You||
4094|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4094|136|S|www.fda.gov/medwatch.||
4094|137|S|   In Canada - Call your doctor for medical advice about side||
4094|138|S|effects. You may report side effects to Health Canada at||
4094|139|S|1-866-234-2345.||
4094|140|B|||
4094|141|P|PRECAUTIONS:  See also Warning section.||
4094|142|P|   Before taking methylphenidate, tell your doctor or pharmacist||
4094|143|P|if you are allergic to it; or to dexmethylphenidate; or if you||
4094|144|P|have any other allergies. This product may contain inactive||
4094|145|P|ingredients, which can cause allergic reactions or other||
4094|146|P|problems. Talk to your pharmacist for more details.||
4094|147|P|   Before using this medication, tell your doctor or pharmacist||
4094|148|P|your medical history, especially of: high blood pressure, blood||
4094|149|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
4094|150|P|problems (such as irregular heartbeat, heart failure, previous||
4094|151|P|heart attack, problems with heart structure), family history of||
4094|152|P|heart problems (such as sudden cardiac death, irregular||
4094|153|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
4094|154|P|agitation), personal/family history of mental/mood disorders||
4094|155|P|(such as bipolar disorder, depression, psychosis, suicidal||
4094|156|P|thoughts), personal/family history of uncontrolled muscle||
4094|157|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
4094|158|P|(hyperthyroidism), seizure disorder, throat/stomach/intestinal||
4094|159|P|problems (such as narrowing/blockage).||
4094|160|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4094|161|P|can make you more dizzy. Do not drive, use machinery, or do||
4094|162|P|anything that needs alertness until you can do it safely. Avoid||
4094|163|P|alcoholic beverages. Talk to your doctor if you are using||
4094|164|P|marijuana (cannabis).||
4094|165|P|   Before having surgery, tell your doctor or dentist about all||
4094|166|P|the products you use (including prescription drugs,||
4094|167|P|nonprescription drugs, and herbal products).||
4094|168|P|   Some brands of this medication may contain sugar. Caution is||
4094|169|P|advised if you have diabetes, fructose intolerance, or any other||
4094|170|P|condition that requires you to limit/avoid sugar in your diet.||
4094|171|P|Ask your doctor or pharmacist about using this medication safely.||
4094|172|P|   Children (especially those younger than 6) may be more||
4094|173|P|sensitive to the side effects of this drug, especially weight||
4094|174|P|loss. If used for a long time, this drug may affect a child's||
4094|175|P|growth rate, weight, and final adult height. To reduce the risk,||
4094|176|P|the doctor may recommend briefly stopping the medication from||
4094|177|P|time to time. Check the child's weight and height regularly, and||
4094|178|P|consult your doctor or pharmacist for more details.||
4094|179|P|   Older adults may be more sensitive to the side effects of this||
4094|180|P|drug, especially trouble sleeping, weight loss, or chest pain.||
4094|181|P|   During pregnancy, methylphenidate should be used only when||
4094|182|P|clearly needed. Discuss the risks and benefits with your doctor.||
4094|183|P|   This medication passes into breast milk. Consult your doctor||
4094|184|P|before breastfeeding.||
4094|185|B|||
4094|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4094|187|I|medications work or increase your risk for serious side effects.||
4094|188|I|This document does not contain all possible drug interactions.||
4094|189|I|Keep a list of all the products you use (including||
4094|190|I|prescription/nonprescription drugs and herbal products) and share||
4094|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
4094|192|I|the dosage of any medicines without your doctor's approval.||
4094|193|I|   Taking MAO inhibitors with this medication may cause a serious||
4094|194|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
4094|195|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
4094|196|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
4094|197|I|selegiline, tranylcypromine) during treatment with this||
4094|198|I|medication. Most MAO inhibitors should also not be taken for two||
4094|199|I|weeks before treatment with this medication. Ask your doctor when||
4094|200|I|to start or stop taking this medication.||
4094|201|I|   Avoid alcohol when using this medication because it may cause||
4094|202|I|the medication to be released too quickly and increase the risk||
4094|203|I|of side effects.||
4094|204|I|   Some brands of this drug may be affected by a change in the||
4094|205|I|amount of acid in your stomach. If you are taking a product to||
4094|206|I|decrease stomach acid (such as antacids, ranitidine, omeprazole),||
4094|207|I|check with your pharmacist to see if your brand may be affected.||
4094|208|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
4094|209|I|use medications containing dexmethylphenidate while using||
4094|210|I|methylphenidate.||
4094|211|I|   This medication may interfere with certain medical/lab tests||
4094|212|I|(such as brain scan for Parkinson's disease), possibly causing||
4094|213|I|false test results. Make sure lab personnel and all your doctors||
4094|214|I|know you use this drug.||
4094|215|B|||
4094|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4094|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4094|218|O|poison control center right away. US residents can call||
4094|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4094|220|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
4094|221|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
4094|222|O|loss of consciousness.||
4094|223|B|||
4094|224|N|NOTES:  Do not share this medication with others. Sharing it is||
4094|225|N|against the law.||
4094|226|N|   Lab and/or medical tests (such as blood pressure, complete||
4094|227|N|blood count, height/weight monitoring in children) may be done||
4094|228|N|while you are taking this medication. Keep all medical and lab||
4094|229|N|appointments. Consult your doctor for more details.||
4094|230|B|||
4094|231|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4094|232|D|remember. If it is near bedtime or near the time of the next||
4094|233|D|dose, skip the missed dose. Take your next dose at the regular||
4094|234|D|time. Do not double the dose to catch up.||
4094|235|B|||
4094|236|R|STORAGE:  Store this medication at room temperature away from||
4094|237|R|light and moisture. Do not store in the bathroom. Keep all||
4094|238|R|medications away from children and pets.||
4094|239|R|   Do not flush medications down the toilet or pour them into a||
4094|240|R|drain unless instructed to do so. Properly discard this product||
4094|241|R|when it is expired or no longer needed. Consult your pharmacist||
4094|242|R|or local waste disposal company.||
4094|243|B|||
4094|244|A|Information last revised July 2025.||
4094|245|A|Copyright(c) 2025 First Databank, Inc.||
4094|246|B|||
4105|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4105|002|Z|does NOT have all possible information about this product. This||
4105|003|Z|information does not assure that this product is safe, effective,||
4105|004|Z|or appropriate for you. This information is not individual||
4105|005|Z|medical advice and does not substitute for the advice of your||
4105|006|Z|health care professional. Always ask your health care||
4105|007|Z|professional for complete information about this product and your||
4105|008|Z|specific health needs.||
4105|009|B|||
4105|010|T|CHLORZOXAZONE - ORAL||
4105|011|F|(klor-ZOX-a-zone)||
4105|012|B|||
4105|013|C|COMMON BRAND NAME(S): Paraflex||
4105|014|B|||
4105|015|U|USES:  Chlorzoxazone is used to treat muscle spasms/pain. It is||
4105|016|U|usually used along with rest, physical therapy, and other||
4105|017|U|treatment. It works by helping to relax the muscles.||
4105|018|B|||
4105|019|H|HOW TO USE:  Take this medication by mouth with or without food||
4105|020|H|as directed by your doctor. Do not increase your dose or use this||
4105|021|H|drug more often or for longer than prescribed. Your condition||
4105|022|H|will not improve any faster, and your risk of side effects will||
4105|023|H|increase.||
4105|024|H|   The dosage is based on your medical condition and response to||
4105|025|H|treatment.||
4105|026|H|   Tell your doctor if your condition does not get better or if||
4105|027|H|it gets worse.||
4105|028|B|||
4105|029|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, tiredness,||
4105|030|S|upset stomach, or headache may occur. If any of these effects||
4105|031|S|last or get worse, tell your doctor or pharmacist promptly.||
4105|032|S|   This medication may rarely cause your urine to turn orange or||
4105|033|S|reddish-purple. This effect is harmless and will disappear when||
4105|034|S|the medication is stopped.||
4105|035|S|   Remember that this medication has been prescribed because your||
4105|036|S|doctor has judged that the benefit to you is greater than the||
4105|037|S|risk of side effects. Many people using this medication do not||
4105|038|S|have serious side effects.||
4105|039|S|   Tell your doctor right away if you have any serious side||
4105|040|S|effects, including: confusion, black/bloody stools, vomit that||
4105|041|S|looks like coffee grounds, easy bruising/bleeding.||
4105|042|S|   This medication may rarely cause very serious (possibly fatal)||
4105|043|S|liver disease. Stop taking this medication and get medical help||
4105|044|S|right away if you develop symptoms of liver disease, including:||
4105|045|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
4105|046|S|yellowing eyes/skin, dark urine.||
4105|047|S|   A very serious allergic reaction to this drug is rare.||
4105|048|S|However, get medical help right away if you notice any symptoms||
4105|049|S|of a serious allergic reaction, including: rash, itching/swelling||
4105|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4105|051|S|breathing.||
4105|052|S|   This is not a complete list of possible side effects. If you||
4105|053|S|notice other effects not listed above, contact your doctor or||
4105|054|S|pharmacist.||
4105|055|S|   In the US -||
4105|056|S|   Call your doctor for medical advice about side effects. You||
4105|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4105|058|S|www.fda.gov/medwatch.||
4105|059|S|   In Canada - Call your doctor for medical advice about side||
4105|060|S|effects. You may report side effects to Health Canada at||
4105|061|S|1-866-234-2345.||
4105|062|B|||
4105|063|P|PRECAUTIONS:  Before taking chlorzoxazone, tell your doctor or||
4105|064|P|pharmacist if you are allergic to it; or if you have any other||
4105|065|P|allergies. This product may contain inactive ingredients, which||
4105|066|P|can cause allergic reactions or other problems. Talk to your||
4105|067|P|pharmacist for more details.||
4105|068|P|   Before using this medication, tell your doctor or pharmacist||
4105|069|P|your medical history, especially of: liver disease.||
4105|070|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4105|071|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4105|072|P|machinery, or do anything that needs alertness until you can do||
4105|073|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
4105|074|P|are using marijuana (cannabis).||
4105|075|P|   Before having surgery, tell your doctor or dentist about all||
4105|076|P|the products you use (including prescription drugs,||
4105|077|P|nonprescription drugs, and herbal products).||
4105|078|P|   Older adults may be more sensitive to the side effects of this||
4105|079|P|drug, especially drowsiness, or confusion. These side effects can||
4105|080|P|increase the risk of falling.||
4105|081|P|   During pregnancy, this medication should be used only when||
4105|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
4105|083|P|   It is unknown if this drug passes into breast milk. Consult||
4105|084|P|your doctor before breastfeeding.||
4105|085|B|||
4105|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4105|087|I|medications work or increase your risk for serious side effects.||
4105|088|I|This document does not contain all possible drug interactions.||
4105|089|I|Keep a list of all the products you use (including||
4105|090|I|prescription/nonprescription drugs and herbal products) and share||
4105|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
4105|092|I|the dosage of any medicines without your doctor's approval.||
4105|093|I|   Tell your doctor or pharmacist if you are taking other||
4105|094|I|products that cause drowsiness such as opioid pain or cough||
4105|095|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4105|096|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4105|097|I|lorazepam, zolpidem), other muscle relaxants (such as||
4105|098|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
4105|099|I|cetirizine, diphenhydramine).||
4105|100|I|   Check the labels on all your medicines (such as allergy or||
4105|101|I|cough-and-cold products) because they may contain ingredients||
4105|102|I|that cause drowsiness. Ask your pharmacist about using those||
4105|103|I|products safely.||
4105|104|B|||
4105|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4105|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4105|107|O|poison control center right away. US residents can call||
4105|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4105|109|O|Symptoms of overdose may include: nausea/vomiting, severe||
4105|110|O|drowsiness, muscle weakness, fast/irregular breathing.||
4105|111|B|||
4105|112|N|NOTES:  Do not share this medication with others.||
4105|113|N|   This medication has been prescribed for your current condition||
4105|114|N|only. Do not use it later for another condition unless your||
4105|115|N|doctor directs you to do so. A different medication may be||
4105|116|N|necessary in that case.||
4105|117|N|   If you are taking this medication for a long time, lab and/or||
4105|118|N|medical tests (such as liver function) should be done while you||
4105|119|N|are taking this medication. Keep all medical and lab||
4105|120|N|appointments. Consult your doctor for more details.||
4105|121|B|||
4105|122|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4105|123|D|remember. If it is near the time of the next dose, skip the||
4105|124|D|missed dose. Take your next dose at the regular time. Do not||
4105|125|D|double the dose to catch up.||
4105|126|B|||
4105|127|R|STORAGE:  Store at room temperature away from light and moisture.||
4105|128|R|Do not store in the bathroom. Keep all medications away from||
4105|129|R|children and pets.||
4105|130|R|   Do not flush medications down the toilet or pour them into a||
4105|131|R|drain unless instructed to do so. Properly discard this product||
4105|132|R|when it is expired or no longer needed. Consult your pharmacist||
4105|133|R|or local waste disposal company.||
4105|134|B|||
4105|135|A|Information last revised May 2025.||
4105|136|A|Copyright(c) 2025 First Databank, Inc.||
4105|137|B|||
4106|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4106|002|Z|does NOT have all possible information about this product. This||
4106|003|Z|information does not assure that this product is safe, effective,||
4106|004|Z|or appropriate for you. This information is not individual||
4106|005|Z|medical advice and does not substitute for the advice of your||
4106|006|Z|health care professional. Always ask your health care||
4106|007|Z|professional for complete information about this product and your||
4106|008|Z|specific health needs.||
4106|009|B|||
4106|010|T|MULTIVITAMINS/FLUORIDE DROPS - ORAL||
4106|011|F|(multivitamins/FLOOR-ide)||
4106|012|B|||
4106|013|U|USES:  This medication is a combination product of vitamins and||
4106|014|U|fluoride. It is used in infants and children to treat or prevent||
4106|015|U|deficiency due to poor diet or low levels of fluoride in drinking||
4106|016|U|water and other sources. Vitamins are important building blocks||
4106|017|U|of the body and help keep you in good health. Fluoride is used to||
4106|018|U|prevent dental cavities.||
4106|019|B|||
4106|020|H|HOW TO USE:  Take this medication by mouth, usually once daily or||
4106|021|H|as directed by the doctor. It is best taken at least 2 hours||
4106|022|H|before or after taking any products containing calcium (including||
4106|023|H|milk, yogurt, other dairy products) or aluminum/magnesium||
4106|024|H|hydroxide (such as certain antacids/laxatives) since these may||
4106|025|H|decrease its effectiveness.||
4106|026|H|   Some brands of this medication should be shaken well before||
4106|027|H|each dose. Check your manufacturer's bottle for specific||
4106|028|H|directions. Carefully measure the dose using the specially marked||
4106|029|H|medicine dropper provided. Drops may be swallowed directly, added||
4106|030|H|to a small amount of liquid, or mixed with a small amount of food||
4106|031|H|such as applesauce.||
4106|032|H|   The fluoride in this liquid product can be absorbed directly||
4106|033|H|into the teeth as you swallow it, as well as being absorbed into||
4106|034|H|your body from your stomach. It is best not to eat, drink, or||
4106|035|H|rinse your mouth for 30 minutes after taking this product.||
4106|036|H|   Take this medication regularly in order to get the most||
4106|037|H|benefit from it. To help you remember, take it at the same time||
4106|038|H|each day. Do not take more than the prescribed dose.||
4106|039|B|||
4106|040|S|SIDE EFFECTS:  Stomach upset, constipation, or nausea may occur.||
4106|041|S|If any of these effects last or get worse, tell the doctor or||
4106|042|S|pharmacist promptly.||
4106|043|S|   If your teeth become mottled or stained, notify the dentist or||
4106|044|S|doctor. This may be a result of too much fluoride.||
4106|045|S|   Remember that this medication has been prescribed because your||
4106|046|S|doctor has judged that the benefit to you is greater than the||
4106|047|S|risk of side effects. Many people using this medication do not||
4106|048|S|have serious side effects.||
4106|049|S|   A very serious allergic reaction to this drug is rare.||
4106|050|S|However, get medical help right away if you notice any symptoms||
4106|051|S|of a serious allergic reaction, including: rash, itching/swelling||
4106|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4106|053|S|breathing.||
4106|054|S|   This is not a complete list of possible side effects. If you||
4106|055|S|notice other effects not listed above, contact your doctor or||
4106|056|S|pharmacist.||
4106|057|S|   In the US -||
4106|058|S|   Call your doctor for medical advice about side effects. You||
4106|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4106|060|S|www.fda.gov/medwatch.||
4106|061|S|   In Canada - Call your doctor for medical advice about side||
4106|062|S|effects. You may report side effects to Health Canada at||
4106|063|S|1-866-234-2345.||
4106|064|B|||
4106|065|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
4106|066|P|pharmacist if you are allergic to any of its ingredients; or if||
4106|067|P|you have any other allergies. This product may contain inactive||
4106|068|P|ingredients, which can cause allergic reactions or other||
4106|069|P|problems. Talk to your pharmacist for more details.||
4106|070|P|   Before taking this medication, tell your doctor or pharmacist||
4106|071|P|your medical history.||
4106|072|P|   Before having surgery, tell your doctor or dentist about all||
4106|073|P|the products you use (including prescription drugs,||
4106|074|P|nonprescription drugs, and herbal products).||
4106|075|P|   Tell your doctor if you are pregnant before taking this||
4106|076|P|medication.||
4106|077|P|   This product passes into breast milk. Consult your doctor||
4106|078|P|before breastfeeding.||
4106|079|B|||
4106|080|I|DRUG INTERACTIONS:  See also How to Use section.||
4106|081|I|   Drug interactions may change how your medications work or||
4106|082|I|increase your risk for serious side effects. This document does||
4106|083|I|not contain all possible drug interactions. Keep a list of all||
4106|084|I|the products you use (including prescription/nonprescription||
4106|085|I|drugs and herbal products) and share it with your doctor and||
4106|086|I|pharmacist. Do not start, stop, or change the dosage of any||
4106|087|I|medicines without your doctor's approval.||
4106|088|B|||
4106|089|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4106|090|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4106|091|O|poison control center right away. US residents can call||
4106|092|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4106|093|O|Symptoms of overdose may include: nausea, vomiting, stomach pain.||
4106|094|B|||
4106|095|N|NOTES:  Do not share this medication with others.||
4106|096|N|   This product is not a substitute for a proper diet. Remember||
4106|097|N|that it is best to get your vitamins from healthy foods. It is||
4106|098|N|important to maintain a well-balanced diet.||
4106|099|N|   Check the fluoride content of your water supply by asking||
4106|100|N|local town or city officials. Fluoride supplements are not||
4106|101|N|necessary if the fluoride content in the water supply is greater||
4106|102|N|than 0.6 parts per million. If your water supply changes, check||
4106|103|N|with your doctor or dentist to determine if extra fluoride is||
4106|104|N|still necessary.||
4106|105|B|||
4106|106|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4106|107|D|remember. If it is near the time of the next dose, skip the||
4106|108|D|missed dose. Take your next dose at the regular time. Do not||
4106|109|D|double the dose to catch up.||
4106|110|B|||
4106|111|R|STORAGE:  Store in the original container away from heat and||
4106|112|R|moisture. Do not store in the bathroom. Keep all medications away||
4106|113|R|from children and pets.||
4106|114|R|   Do not flush medications down the toilet or pour them into a||
4106|115|R|drain unless instructed to do so. Properly discard this product||
4106|116|R|when it is expired or no longer needed. Consult your pharmacist||
4106|117|R|or local waste disposal company.||
4106|118|B|||
4106|119|A|Information last revised October 2025.||
4106|120|A|Copyright(c) 2025 First Databank, Inc.||
4106|121|B|||
4108|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4108|002|Z|does NOT have all possible information about this product. This||
4108|003|Z|information does not assure that this product is safe, effective,||
4108|004|Z|or appropriate for you. This information is not individual||
4108|005|Z|medical advice and does not substitute for the advice of your||
4108|006|Z|health care professional. Always ask your health care||
4108|007|Z|professional for complete information about this product and your||
4108|008|Z|specific health needs.||
4108|009|B|||
4108|010|T|CYCLOSPORINE MICROEMULSION CAPSULE - ORAL||
4108|011|F|(SYE-kloe-SPOR-in MY-crow-ee-MULL-shun)||
4108|012|B|||
4108|013|C|COMMON BRAND NAME(S): Gengraf, Neoral||
4108|014|B|||
4108|015|W|WARNING:  Cyclosporine lowers your ability to fight infections.||
4108|016|W|This may make you more likely to get a serious (rarely fatal)||
4108|017|W|infection or make any infection you have worse. This effect may||
4108|018|W|also increase your risk of getting certain types of cancer (such||
4108|019|W|as skin cancer, lymphoma). Tell your doctor right away if you||
4108|020|W|have any signs of infection or cancer such as sore throat that||
4108|021|W|doesn't go away, fever, chills, burning/frequent urination,||
4108|022|W|unusual skin changes, change in appearance or size of moles,||
4108|023|W|unusual weight loss, swollen lymph nodes, unusual lumps, night||
4108|024|W|sweats.||
4108|025|W|   Cyclosporine can also cause high blood pressure and kidney||
4108|026|W|problems. The risk of both problems increases with higher doses||
4108|027|W|and longer treatment with this drug. Your doctor will monitor||
4108|028|W|your blood pressure and kidney function while you take this||
4108|029|W|medication.||
4108|030|W|   Psoriasis patients who have had certain previous treatments||
4108|031|W|(such as coal tar, methotrexate, radiation treatment, light||
4108|032|W|treatment with PUVA/UVB) are at increased risk to develop skin||
4108|033|W|cancer. Talk to your doctor of the risks and benefits of this||
4108|034|W|medication.||
4108|035|W|   Different brands of this medication may deliver different||
4108|036|W|amounts of medication. Do not switch brands of cyclosporine||
4108|037|W|without your doctor's permission and directions.||
4108|038|B|||
4108|039|U|USES:  Cyclosporine is used to prevent organ rejection in people||
4108|040|U|who have received a liver, kidney, or heart transplant. It is||
4108|041|U|usually taken along with other medications to allow your new||
4108|042|U|organ to function normally. Cyclosporine is also used to treat||
4108|043|U|severe cases of rheumatoid arthritis and plaque psoriasis. In||
4108|044|U|these conditions, the body's defense system (immune system)||
4108|045|U|attacks healthy tissues. Cyclosporine belongs to a class of drugs||
4108|046|U|known as immunosuppressants. It works by weakening the immune||
4108|047|U|system to help your body accept the new organ as if it were your||
4108|048|U|own (in the case of an organ transplant) and to prevent further||
4108|049|U|damage to your joints (in the case of rheumatoid arthritis) or||
4108|050|U|skin (in the case of psoriasis).||
4108|051|B|||
4108|052|V|OTHER USES:  This section contains uses of this drug that are not||
4108|053|V|listed in the approved professional labeling for the drug but||
4108|054|V|that may be prescribed by your health care professional. Use this||
4108|055|V|drug for a condition that is listed in this section only if it||
4108|056|V|has been so prescribed by your health care professional.||
4108|057|V|   This drug may also be used to reduce the risk of rejection in||
4108|058|V|other types of organ transplants (such as cornea, pancreas) or||
4108|059|V|bone marrow transplant. It may also be used for other conditions||
4108|060|V|that are affected by the body's immune system (such as Crohn's||
4108|061|V|disease).||
4108|062|B|||
4108|063|H|HOW TO USE:  Take this medication by mouth as directed by your||
4108|064|H|doctor, usually twice daily. You may take this medication with or||
4108|065|H|without food, but it is important to choose one way and take this||
4108|066|H|medication the same way with every dose.||
4108|067|H|   The dosage is based on your weight, medical condition, lab||
4108|068|H|tests, and response to treatment.||
4108|069|H|   Avoid eating grapefruit or drinking grapefruit juice while||
4108|070|H|using this medication unless your doctor or pharmacist says you||
4108|071|H|may do so safely. Grapefruit can increase the chance of side||
4108|072|H|effects with this medicine. Ask your doctor or pharmacist for||
4108|073|H|more details.||
4108|074|H|   Use this medication regularly to get the most benefit from it.||
4108|075|H|To help you remember, take it at the same times each day.||
4108|076|H|   It may take up to 4 months before you get the full benefit of||
4108|077|H|this drug for the treatment of rheumatoid arthritis and||
4108|078|H|psoriasis.||
4108|079|H|   Tell your doctor if your condition does not get better (in 4||
4108|080|H|to 8 weeks for arthritis and in 2 to 4 weeks for psoriasis) or if||
4108|081|H|it gets worse.||
4108|082|B|||
4108|083|S|SIDE EFFECTS:  See also Warning section.||
4108|084|S|   Shaking, headache, dizziness, unusual growth of body hair,||
4108|085|S|nausea/vomiting, diarrhea, stomach upset, or flushing may occur.||
4108|086|S|If any of these effects last or get worse, tell your doctor or||
4108|087|S|pharmacist promptly.||
4108|088|S|   Unusual growth and swelling of the gums may occur. Brush your||
4108|089|S|teeth and floss daily to reduce this problem. See your dentist||
4108|090|S|regularly.||
4108|091|S|   Remember that this medication has been prescribed because your||
4108|092|S|doctor has judged that the benefit to you is greater than the||
4108|093|S|risk of side effects. Many people using this medication do not||
4108|094|S|have serious side effects.||
4108|095|S|   This medication may raise your blood pressure. Check your||
4108|096|S|blood pressure regularly and tell your doctor if the results are||
4108|097|S|high. Your doctor may control your blood pressure with||
4108|098|S|medication.||
4108|099|S|   Tell your doctor right away if you have any serious side||
4108|100|S|effects, including: signs of kidney problems (such as a change in||
4108|101|S|the amount of urine), signs of liver disease (such as||
4108|102|S|nausea/vomiting that doesn't stop, dark urine, yellowing||
4108|103|S|eyes/skin, stomach/abdominal pain), easy bruising/bleeding,||
4108|104|S|unusual tiredness, muscle weakness/spasms, slow/irregular||
4108|105|S|heartbeat, numb/tingling skin, severe leg pain.||
4108|106|S|   Get medical help right away if you have any very serious side||
4108|107|S|effects, including: mental/mood changes (such as confusion,||
4108|108|S|difficulty concentrating), vision changes, problems with speech,||
4108|109|S|clumsiness, loss of coordination, weakness on one side of the||
4108|110|S|body, seizures, chest pain.||
4108|111|S|   A very serious allergic reaction to this drug is rare.||
4108|112|S|However, get medical help right away if you notice any symptoms||
4108|113|S|of a serious allergic reaction, including: rash, itching/swelling||
4108|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4108|115|S|breathing.||
4108|116|S|   This is not a complete list of possible side effects. If you||
4108|117|S|notice other effects not listed above, contact your doctor or||
4108|118|S|pharmacist.||
4108|119|S|   In the US -||
4108|120|S|   Call your doctor for medical advice about side effects. You||
4108|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4108|122|S|www.fda.gov/medwatch.||
4108|123|S|   In Canada - Call your doctor for medical advice about side||
4108|124|S|effects. You may report side effects to Health Canada at||
4108|125|S|1-866-234-2345.||
4108|126|B|||
4108|127|P|PRECAUTIONS:  Before taking cyclosporine, tell your doctor or||
4108|128|P|pharmacist if you are allergic to it; or if you have any other||
4108|129|P|allergies. This product may contain inactive ingredients, which||
4108|130|P|can cause allergic reactions or other problems. Talk to your||
4108|131|P|pharmacist for more details.||
4108|132|P|   Before using this medication, tell your doctor or pharmacist||
4108|133|P|your medical history, especially of: kidney disease, liver||
4108|134|P|disease, high blood pressure, cancer, skin lesions of unknown||
4108|135|P|cause, radiation treatment (including light treatment with PUVA||
4108|136|P|or UVB), mineral imbalance (such as low level of magnesium or||
4108|137|P|high level of potassium), recent/current infections, high||
4108|138|P|cholesterol/triglycerides levels.||
4108|139|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4108|140|P|can make you more dizzy. Do not drive, use machinery, or do||
4108|141|P|anything that needs alertness until you can do it safely. Limit||
4108|142|P|alcoholic beverages. Talk to your doctor if you are using||
4108|143|P|marijuana (cannabis).||
4108|144|P|   This medication may contain alcohol. Caution is advised if you||
4108|145|P|are pregnant or breastfeeding or have liver disease, alcohol||
4108|146|P|dependence, or any other condition that requires you to||
4108|147|P|limit/avoid alcohol in your diet. Ask your doctor or pharmacist||
4108|148|P|about using this product safely.||
4108|149|P|   Cyclosporine can make you more likely to get infections or may||
4108|150|P|make current infections worse. Stay away from anyone who has an||
4108|151|P|infection that may easily spread (such as chickenpox, COVID-19,||
4108|152|P|measles, flu). Talk to your doctor if you have been exposed to an||
4108|153|P|infection or for more details.||
4108|154|P|   Tell your health care professional that you are using||
4108|155|P|cyclosporine before having any immunizations/vaccinations. Avoid||
4108|156|P|contact with people who have recently received live vaccines||
4108|157|P|(such as flu vaccine inhaled through the nose).||
4108|158|P|   This medication may increase your risk of developing skin||
4108|159|P|cancer. Limit your time in the sun. Avoid tanning booths and||
4108|160|P|sunlamps. Use sunscreen and wear protective clothing when||
4108|161|P|outdoors. Your doctor may direct you to avoid phototherapy while||
4108|162|P|you use this product. Ask your doctor for details.||
4108|163|P|   This product may increase your potassium levels. Before using||
4108|164|P|potassium supplements or salt substitutes that contain potassium,||
4108|165|P|consult your doctor or pharmacist.||
4108|166|P|   Before having surgery, tell your doctor or dentist about all||
4108|167|P|the products you use (including prescription drugs,||
4108|168|P|nonprescription drugs, and herbal products).||
4108|169|P|   Older adults may be at greater risk for kidney problems or||
4108|170|P|high blood pressure while using this drug.||
4108|171|P|   During pregnancy, this medication should be used only when||
4108|172|P|clearly needed. It may harm an unborn baby or cause other||
4108|173|P|problems with the baby such as being born too early (premature)||
4108|174|P|or having low birth weight. Discuss the risks and benefits with||
4108|175|P|your doctor.||
4108|176|P|   This medication passes into breast milk. Consult your doctor||
4108|177|P|before breastfeeding.||
4108|178|B|||
4108|179|I|DRUG INTERACTIONS:  See also How to Use section.||
4108|180|I|   Drug interactions may change how your medications work or||
4108|181|I|increase your risk for serious side effects. This document does||
4108|182|I|not contain all possible drug interactions. Keep a list of all||
4108|183|I|the products you use (including prescription/nonprescription||
4108|184|I|drugs and herbal products) and share it with your doctor and||
4108|185|I|pharmacist. Do not start, stop, or change the dosage of any||
4108|186|I|medicines without your doctor's approval.||
4108|187|I|   Some products that may interact with this drug include: coal||
4108|188|I|tar, orlistat, other drugs that weaken the immune system/increase||
4108|189|I|the risk of infection (such as natalizumab, rituximab,||
4108|190|I|tofacitinib), drugs that may increase potassium levels (such as||
4108|191|I|potassium supplements, certain diuretics/"water pills" including||
4108|192|I|amiloride, spironolactone), tacrolimus.||
4108|193|I|   Other medications can affect the removal of cyclosporine from||
4108|194|I|your body, which may affect how cyclosporine works. Examples||
4108|195|I|include bosentan, mifepristone, St. John's wort, ritonavir, among||
4108|196|I|others.||
4108|197|I|   This medication can slow down the removal of other medications||
4108|198|I|from your body, which may affect how they work. Examples of||
4108|199|I|affected drugs include aliskiren, dabigatran, dronedarone,||
4108|200|I|elagolix, resmetirom, certain statins (such as pitavastatin,||
4108|201|I|simvastatin), voxilaprevir, among others.||
4108|202|B|||
4108|203|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4108|204|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4108|205|O|poison control center right away. US residents can call||
4108|206|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4108|207|B|||
4108|208|N|NOTES:  Do not share this medication with others.||
4108|209|N|   Lab and/or medical tests (such as kidney/liver function, blood||
4108|210|N|pressure, blood mineral levels, cyclosporine blood levels,||
4108|211|N|complete blood count, uric acid levels, lipid levels, skin exam)||
4108|212|N|should be done while you are taking this medication. Keep all||
4108|213|N|medical and lab appointments. Consult your doctor for more||
4108|214|N|details.||
4108|215|N|   If you have had an organ transplant, it is recommended that||
4108|216|N|you attend a transplant education class or support group. Learn||
4108|217|N|the symptoms of organ rejection such as a feeling of being ill,||
4108|218|N|fever, pain around the transplanted organ, and signs of a failing||
4108|219|N|transplanted organ (a decrease in the amount of urine with kidney||
4108|220|N|transplant, yellowing of the skin/eyes with liver transplant,||
4108|221|N|shortness of breath/inability to exercise with heart transplant).||
4108|222|N|Get medical help right away if these symptoms of rejection occur.||
4108|223|B|||
4108|224|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4108|225|D|remember. If it is near the time of the next dose, skip the||
4108|226|D|missed dose. Take your next dose at the regular time. Do not||
4108|227|D|double the dose to catch up.||
4108|228|B|||
4108|229|R|STORAGE:  Store in the original blister pack at room temperature||
4108|230|R|away from heat and moisture. Do not store in the bathroom. Keep||
4108|231|R|all medications away from children and pets.||
4108|232|R|   Do not flush medications down the toilet or pour them into a||
4108|233|R|drain unless instructed to do so. Properly discard this product||
4108|234|R|when it is expired or no longer needed. Consult your pharmacist||
4108|235|R|or local waste disposal company.||
4108|236|B|||
4108|237|M|MEDICAL ALERT:  Your condition can cause complications in a||
4108|238|M|medical emergency. For information about enrolling in MedicAlert,||
4108|239|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4108|240|B|||
4108|241|A|Information last revised May 2025.||
4108|242|A|Copyright(c) 2025 First Databank, Inc.||
4108|243|B|||
4112|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4112|002|Z|does NOT have all possible information about this product. This||
4112|003|Z|information does not assure that this product is safe, effective,||
4112|004|Z|or appropriate for you. This information is not individual||
4112|005|Z|medical advice and does not substitute for the advice of your||
4112|006|Z|health care professional. Always ask your health care||
4112|007|Z|professional for complete information about this product and your||
4112|008|Z|specific health needs.||
4112|009|B|||
4112|010|T|DESMOPRESSIN 0.1 MG/ML SPRAY - NASAL||
4112|011|F|(dess-mow-PRESS-in)||
4112|012|B|||
4112|013|C|COMMON BRAND NAME(S): DDAVP||
4112|014|B|||
4112|015|W|WARNING:  Desmopressin can rarely cause a low level of sodium in||
4112|016|W|the blood (hyponatremia), which can be serious or even fatal.||
4112|017|W|Drinking too much liquid, using certain medications (such as||
4112|018|W|"water pills"/diuretics including furosemide, corticosteroids||
4112|019|W|such as prednisone), being 65 years or older, or having certain||
4112|020|W|medical conditions may increase the risk of low sodium in the||
4112|021|W|blood. Lab tests (such as urine tests, sodium blood levels) must||
4112|022|W|be done before you start using this medication and while you are||
4112|023|W|using it. Keep all medical and lab appointments.||
4112|024|W|   Tell your doctor right away if you develop symptoms of low||
4112|025|W|sodium in the blood, such as nausea, vomiting, headache, muscle||
4112|026|W|weakness/cramps, unusual tiredness, unusual drowsiness,||
4112|027|W|dizziness, restlessness, mental/mood changes including||
4112|028|W|confusion/irritability.||
4112|029|W|   Get medical help right away if you have any very serious side||
4112|030|W|effects, including seizure or trouble breathing.||
4112|031|B|||
4112|032|U|USES:  Desmopressin is used to control the amount of urine your||
4112|033|U|kidneys make. Normally, the amount of urine you make is||
4112|034|U|controlled by a certain substance in the body called vasopressin.||
4112|035|U|In people who have "water diabetes" (diabetes insipidus) or||
4112|036|U|certain kinds of head injury or brain surgery, the body does not||
4112|037|U|make enough vasopressin. Desmopressin is a man-made form of||
4112|038|U|vasopressin and is used to replace a low level of vasopressin.||
4112|039|U|This medication helps to control increased thirst and too much||
4112|040|U|urination due to these conditions, and helps prevent dehydration.||
4112|041|U|   Desmopressin products applied in the nose are no longer||
4112|042|U|indicated to control nighttime bedwetting in children because of||
4112|043|U|the increased risk of developing a serious side effect (a low||
4112|044|U|level of sodium in the blood).||
4112|045|B|||
4112|046|H|HOW TO USE:  Read the Patient Information Leaflet and||
4112|047|H|instructions that come with this product before you start using||
4112|048|H|desmopressin and each time you get a refill. If you have any||
4112|049|H|questions, consult your doctor or pharmacist.||
4112|050|H|   Follow the instructions on how to properly prime the bottle if||
4112|051|H|you are using it for the first time or if you have not used it||
4112|052|H|for a week or more. Spray this medication in the nose, usually 1||
4112|053|H|to 3 times a day as directed by your doctor. If the dose is more||
4112|054|H|than 1 spray, spray half the dose in each nostril. For example,||
4112|055|H|if the dose is 2 sprays, give 1 spray in each nostril.||
4112|056|H|   Keep track of the number of sprays used from each container.||
4112|057|H|Discard the container after you have used the number of sprays||
4112|058|H|specified on the package.||
4112|059|H|   If a child is using this medication, a parent or other||
4112|060|H|responsible adult should supervise and help the child use this||
4112|061|H|medication properly.||
4112|062|H|   Limit drinking of water and other fluids while using this||
4112|063|H|medication, especially in children and older adults. Consult your||
4112|064|H|doctor for details. If you find that you are drinking more fluids||
4112|065|H|than directed, tell your doctor right away. Your treatment will||
4112|066|H|need to be adjusted.||
4112|067|H|   Dosage is based on your medical condition and response to||
4112|068|H|treatment. Do not use more desmopressin or use it more often than||
4112|069|H|prescribed.||
4112|070|H|   Use this medication regularly to get the most benefit from it.||
4112|071|H|To help you remember, use it at the same time(s) each day.||
4112|072|H|   Tell your doctor if your condition does not get better or if||
4112|073|H|this medication stops working well.||
4112|074|B|||
4112|075|S|SIDE EFFECTS:  See also Warning section.||
4112|076|S|   Headache, runny/stuffy nose, nausea, upset stomach, or||
4112|077|S|flushing of the face may occur. If any of these effects last or||
4112|078|S|get worse, tell your doctor or pharmacist promptly.||
4112|079|S|   Remember that this medication has been prescribed because your||
4112|080|S|doctor has judged that the benefit to you is greater than the||
4112|081|S|risk of side effects. Many people using this medication do not||
4112|082|S|have serious side effects.||
4112|083|S|   A very serious allergic reaction to this drug is rare.||
4112|084|S|However, get medical help right away if you notice any symptoms||
4112|085|S|of a serious allergic reaction, including: rash, itching/swelling||
4112|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4112|087|S|breathing.||
4112|088|S|   This is not a complete list of possible side effects. If you||
4112|089|S|notice other effects not listed above, contact your doctor or||
4112|090|S|pharmacist.||
4112|091|S|   In the US -||
4112|092|S|   Call your doctor for medical advice about side effects. You||
4112|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4112|094|S|www.fda.gov/medwatch.||
4112|095|S|   In Canada - Call your doctor for medical advice about side||
4112|096|S|effects. You may report side effects to Health Canada at||
4112|097|S|1-866-234-2345.||
4112|098|B|||
4112|099|P|PRECAUTIONS:  Before using desmopressin, tell your doctor or||
4112|100|P|pharmacist if you are allergic to it; or if you have any other||
4112|101|P|allergies. This product may contain inactive ingredients, which||
4112|102|P|can cause allergic reactions or other problems. Talk to your||
4112|103|P|pharmacist for more details.||
4112|104|P|   Before using this medication, tell your doctor or pharmacist||
4112|105|P|your medical history, especially of: kidney disease, heart||
4112|106|P|problems (such as blocked blood vessels, heart failure), high||
4112|107|P|blood pressure, conditions that may increase your risk of||
4112|108|P|fluid/mineral imbalance (such as cystic fibrosis), the urge to||
4112|109|P|drink too much water without being thirsty, a low level of sodium||
4112|110|P|in the blood (hyponatremia), bleeding/clotting problems.||
4112|111|P|   If you become dehydrated, your doctor will correct that||
4112|112|P|condition first before starting treatment with desmopressin.||
4112|113|P|   Limit alcohol because it can interfere with how well||
4112|114|P|desmopressin works.||
4112|115|P|   Changes inside the nose (such as scarring, swelling,||
4112|116|P|congestion, or blockage) may affect how well desmopressin is||
4112|117|P|absorbed. Tell your doctor if you have any of these changes||
4112|118|P|inside the nose because your doctor may need to adjust your||
4112|119|P|treatment.||
4112|120|P|   Tell the doctor right away if you develop any illness that can||
4112|121|P|cause water/mineral imbalance (including fever, diarrhea,||
4112|122|P|vomiting, infections such as the flu) or if you experience||
4112|123|P|conditions that require drinking more fluids (for example,||
4112|124|P|exposure to very hot weather, strenuous exercise, heavy||
4112|125|P|sweating). The doctor may need to stop or adjust desmopressin||
4112|126|P|treatment, especially in children and older adults.||
4112|127|P|   Children may be more sensitive to the side effects of this||
4112|128|P|drug, especially water/mineral imbalance and a low level of||
4112|129|P|sodium in the blood.||
4112|130|P|   Older adults may be at greater risk for water/mineral||
4112|131|P|imbalance and a low level of sodium in the blood while using this||
4112|132|P|drug.||
4112|133|P|   During pregnancy, this medication should be used only when||
4112|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
4112|135|P|   This medication passes into breast milk. Consult your doctor||
4112|136|P|before breastfeeding.||
4112|137|B|||
4112|138|I|DRUG INTERACTIONS:  See also Warning section.||
4112|139|I|   Drug interactions may change how your medications work or||
4112|140|I|increase your risk for serious side effects. This document does||
4112|141|I|not contain all possible drug interactions. Keep a list of all||
4112|142|I|the products you use (including prescription/nonprescription||
4112|143|I|drugs and herbal products) and share it with your doctor and||
4112|144|I|pharmacist. Do not start, stop, or change the dosage of any||
4112|145|I|medicines without your doctor's approval.||
4112|146|I|   Some products that may interact with this drug are:||
4112|147|I|corticosteroids that are taken by mouth or inhaled (such as||
4112|148|I|fluticasone, prednisone), tolvaptan, "water pills"/diuretics||
4112|149|I|(such as furosemide).||
4112|150|B|||
4112|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4112|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4112|153|O|poison control center right away. US residents can call||
4112|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4112|155|O|Symptoms of overdose may include: headache that is severe or||
4112|156|O|doesn't go away, confusion, drowsiness, sudden weight gain.||
4112|157|B|||
4112|158|N|NOTES:  Do not share this medication with others.||
4112|159|N|   Lab and/or medical tests (such as urine tests, sodium blood||
4112|160|N|level) may be done while you are using this medication. Keep all||
4112|161|N|medical and lab appointments. Consult your doctor for more||
4112|162|N|details.||
4112|163|B|||
4112|164|D|MISSED DOSE:  If you use 1 dose daily and miss a dose, use it as||
4112|165|D|soon as you remember. If you do not remember until the next day,||
4112|166|D|skip the missed dose. Use your next dose at the regular time. Do||
4112|167|D|not double the dose to catch up.||
4112|168|D|   If you use more than 1 dose daily and miss a dose, use it as||
4112|169|D|soon as you remember. If it is near the time of the next dose,||
4112|170|D|skip the missed dose. Use your next dose at the regular time. Do||
4112|171|D|not double the dose to catch up.||
4112|172|B|||
4112|173|R|STORAGE:  Store at room temperature away from light. Keep the||
4112|174|R|bottle upright. Keep all medications away from children and pets.||
4112|175|R|   Do not flush medications down the toilet or pour them into a||
4112|176|R|drain unless instructed to do so. Properly discard this product||
4112|177|R|when it is expired or no longer needed. Consult your pharmacist||
4112|178|R|or local waste disposal company.||
4112|179|B|||
4112|180|A|Information last revised January 2025.||
4112|181|A|Copyright(c) 2025 First Databank, Inc.||
4112|182|B|||
4115|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4115|002|Z|does NOT have all possible information about this product. This||
4115|003|Z|information does not assure that this product is safe, effective,||
4115|004|Z|or appropriate for you. This information is not individual||
4115|005|Z|medical advice and does not substitute for the advice of your||
4115|006|Z|health care professional. Always ask your health care||
4115|007|Z|professional for complete information about this product and your||
4115|008|Z|specific health needs.||
4115|009|B|||
4115|010|T|NORELGESTROMIN/ETHINYL ESTRADIOL PATCH - TRANSDERMAL||
4115|011|F|(NOR-el-JES-troe-min/ETH-i-nil ES-tra-DYE-ol)||
4115|012|B|||
4115|013|C|COMMON BRAND NAME(S): Ortho Evra||
4115|014|B|||
4115|015|W|WARNING:  Smoking raises your risk of stroke, heart attack, blood||
4115|016|W|clots, and high blood pressure from hormonal birth control (such||
4115|017|W|as the pill, patch, ring). The risk of these serious problems is||
4115|018|W|higher if you are obese and increases with age and with the||
4115|019|W|number of cigarettes you smoke. Do not use this medication if you||
4115|020|W|are obese, or if you smoke cigarettes/use tobacco and are over 35||
4115|021|W|years old.||
4115|022|W|   The amount of estrogen you receive when using the patch is||
4115|023|W|higher than the amount from most birth control pills. This may||
4115|024|W|increase the risk for blood clots or other side effects from the||
4115|025|W|patch compared to oral contraceptives. Talk to your doctor for||
4115|026|W|more details.||
4115|027|B|||
4115|028|U|USES:  This patch contains combination hormone medication and is||
4115|029|U|used to prevent pregnancy. It contains 2 hormones: a progestin||
4115|030|U|(norelgestromin) and an estrogen (ethinyl estradiol).||
4115|031|U|   This product does not protect against sexually transmitted||
4115|032|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
4115|033|U|an effective barrier method (latex or polyurethane condom/dental||
4115|034|U|dams) during sexual activity will help to decrease your risk of||
4115|035|U|infection.||
4115|036|B|||
4115|037|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
4115|038|H|your pharmacist before you start using this medication and each||
4115|039|H|time you get a refill. The leaflet contains very important||
4115|040|H|information on how to properly use and dispose of the patch. If||
4115|041|H|you have any questions, ask your doctor or pharmacist.||
4115|042|H|   Do not cut or damage the patch. Remove the patch from the foil||
4115|043|H|pouch and apply as directed by the manufacturer to clean, dry||
4115|044|H|skin on the upper outer arm, abdomen, buttock, or upper body||
4115|045|H|where it will not be rubbed by tight clothing. Do not apply the||
4115|046|H|patch to your breasts or on red/cut/irritated skin. Do not use||
4115|047|H|lotions, creams, oils, powders, or make-up at the patch site,||
4115|048|H|since it may not stick properly or may fall off.||
4115|049|H|   If this is your first time using this medication, apply the||
4115|050|H|patch on the first Sunday following the beginning of your||
4115|051|H|menstrual period or on the first day of your period. If your||
4115|052|H|period begins on a Sunday, begin on that day. For the first cycle||
4115|053|H|of use only, use a backup form of non-hormonal birth control||
4115|054|H|(such as condoms, spermicide) for the first 7 days to prevent||
4115|055|H|pregnancy until the medication has enough time to work. If you||
4115|056|H|start using the patch on the first day of your period, you do not||
4115|057|H|need to use backup birth control the first week.||
4115|058|H|   Change the patch once a week on the same day. Remove the used||
4115|059|H|patch before placing a new one. Apply the patch to a different||
4115|060|H|area with each change to avoid skin irritation. After wearing||
4115|061|H|patches for 3 weeks in a row, do not wear a patch during week 4.||
4115|062|H|You should have your period during this time. After not wearing a||
4115|063|H|patch for a week, apply a new patch whether or not you have your||
4115|064|H|period. If you do not get your period, consult your doctor. Do||
4115|065|H|not go longer than 7 days without a patch, since this will||
4115|066|H|increase your chance of pregnancy. To help you remember, mark||
4115|067|H|your calendar to remind yourself when to change or leave off||
4115|068|H|patches.||
4115|069|H|   If the patch falls off, re-apply it or apply a new patch||
4115|070|H|within 24 hours. If the patch is not replaced within 24 hours, or||
4115|071|H|if you are not sure how long it has been off, start a new cycle||
4115|072|H|by applying a new patch and use a backup form of non-hormonal||
4115|073|H|birth control (such as condoms, spermicide) for the next 7 days||
4115|074|H|to prevent pregnancy.||
4115|075|H|   After removing each patch, fold it in half so it sticks to||
4115|076|H|itself, and discard in the trash away from children and pets. Do||
4115|077|H|not flush the patch down the toilet.||
4115|078|H|   Ask your doctor or pharmacist about how to switch from other||
4115|079|H|forms of hormonal birth control (such as birth control pills) to||
4115|080|H|this product. If any information is unclear, consult the Patient||
4115|081|H|Information Leaflet or your doctor or pharmacist.||
4115|082|B|||
4115|083|S|SIDE EFFECTS:  Skin irritation at the application site, nausea,||
4115|084|S|vomiting, headache, bloating, breast tenderness, swelling of the||
4115|085|S|ankles/feet (fluid retention), or weight change may occur.||
4115|086|S|Vaginal bleeding between periods (spotting) may occur, especially||
4115|087|S|during the first few months of use. If any of these effects last||
4115|088|S|or get worse, tell your doctor or pharmacist promptly. If you||
4115|089|S|miss 2 periods in a row (or 1 period if the patch has not been||
4115|090|S|used properly), talk to your doctor about a pregnancy test.||
4115|091|S|   Remember that this medication has been prescribed because your||
4115|092|S|doctor has judged that the benefit to you is greater than the||
4115|093|S|risk of side effects. Many people using this medication do not||
4115|094|S|have serious side effects.||
4115|095|S|   This medication may raise your blood pressure. Check your||
4115|096|S|blood pressure regularly and tell your doctor if the results are||
4115|097|S|high.||
4115|098|S|   Tell your doctor right away if you have any serious side||
4115|099|S|effects, including: lumps in the breast, mental/mood changes||
4115|100|S|(such as new/worsening depression), severe stomach/abdominal||
4115|101|S|pain, unusual changes in vaginal bleeding (such as continuous||
4115|102|S|spotting, sudden heavy bleeding, missed periods), dark urine,||
4115|103|S|yellowing eyes/skin.||
4115|104|S|   This medication may rarely cause serious (sometimes fatal)||
4115|105|S|problems from blood clots (such as heart attack, stroke, blood||
4115|106|S|clots in the lungs or legs). Get medical help right away if you||
4115|107|S|have: chest/jaw/left arm pain, confusion, sudden||
4115|108|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
4115|109|S|trouble speaking, shortness of breath/rapid breathing,||
4115|110|S|sudden/severe headaches, unusual sweating, weakness on one side||
4115|111|S|of the body, sudden vision changes.||
4115|112|S|   A very serious allergic reaction to this drug is rare.||
4115|113|S|However, get medical help right away if you notice any symptoms||
4115|114|S|of a serious allergic reaction, including: rash, itching/swelling||
4115|115|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4115|116|S|breathing.||
4115|117|S|   This is not a complete list of possible side effects. If you||
4115|118|S|notice other effects not listed above, contact your doctor or||
4115|119|S|pharmacist.||
4115|120|S|   In the US -||
4115|121|S|   Call your doctor for medical advice about side effects. You||
4115|122|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4115|123|S|www.fda.gov/medwatch.||
4115|124|S|   In Canada - Call your doctor for medical advice about side||
4115|125|S|effects. You may report side effects to Health Canada at||
4115|126|S|1-866-234-2345.||
4115|127|B|||
4115|128|P|PRECAUTIONS:  See also Warning section.||
4115|129|P|   Before using this medication patch, tell your doctor or||
4115|130|P|pharmacist if you are allergic to ethinyl estradiol or||
4115|131|P|norelgestromin; or to other estrogens or progestins; or if you||
4115|132|P|have any other allergies. This product may contain inactive||
4115|133|P|ingredients, which can cause allergic reactions or other||
4115|134|P|problems. Talk to your pharmacist for more details.||
4115|135|P|   Before using this medication, tell your doctor or pharmacist||
4115|136|P|your medical history, especially of: blood clots (for example, in||
4115|137|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
4115|138|P|C or protein S deficiency), high blood pressure, abnormal breast||
4115|139|P|exam, cancer (especially endometrial or breast cancer), high||
4115|140|P|cholesterol or triglyceride (blood fat) levels, depression,||
4115|141|P|diabetes, family or personal history of a certain swelling||
4115|142|P|disorder (angioedema), gallbladder problems, severe||
4115|143|P|headaches/migraines, heart problems (such as heart valve disease,||
4115|144|P|irregular heartbeat, previous heart attack), history of yellowing||
4115|145|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
4115|146|P|birth control (such as pills, patch), liver disease (including||
4115|147|P|tumors), stroke, swelling (edema), thyroid problems, unexplained||
4115|148|P|vaginal bleeding.||
4115|149|P|   If you weigh more than 198 pounds (90 kilograms), this patch||
4115|150|P|may not work well for you. Make sure your doctor knows your||
4115|151|P|current weight, and ask about which form of birth control will||
4115|152|P|work best for you.||
4115|153|P|   If you have diabetes, this medication may affect your blood||
4115|154|P|sugar. Check your blood sugar regularly as directed and share the||
4115|155|P|results with your doctor. Tell your doctor right away if you have||
4115|156|P|symptoms of high blood sugar such as increased thirst/urination.||
4115|157|P|Your doctor may need to adjust your diabetes medication, exercise||
4115|158|P|program, or diet.||
4115|159|P|   Tell your doctor if you just had or will be having surgery or||
4115|160|P|if you will be confined to a bed or chair for a long time (such||
4115|161|P|as a long plane flight). These conditions increase your risk of||
4115|162|P|getting blood clots, especially if you are using hormonal birth||
4115|163|P|control. You may need to stop this medication for a time or take||
4115|164|P|special precautions.||
4115|165|P|   Before having surgery, tell your doctor or dentist about all||
4115|166|P|the products you use (including prescription drugs,||
4115|167|P|nonprescription drugs, and herbal products).||
4115|168|P|   This product may cause blotchy, dark areas on your face and||
4115|169|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
4115|170|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
4115|171|P|wear protective clothing when outdoors.||
4115|172|P|   If you are nearsighted or wear contact lenses, you may develop||
4115|173|P|vision problems or trouble wearing your contact lenses. Contact||
4115|174|P|your eye doctor if these problems occur.||
4115|175|P|   If you are going to have an MRI test, tell testing personnel||
4115|176|P|that you are using this patch. Some patches may contain metals||
4115|177|P|that can cause serious burns during an MRI. Ask your doctor||
4115|178|P|whether you will need to remove your patch before the test and||
4115|179|P|apply a new patch afterward, and how to do so properly.||
4115|180|P|   This medication must not be used during pregnancy. If you||
4115|181|P|become pregnant or think you may be pregnant, tell your doctor||
4115|182|P|right away. If you have just given birth or had a pregnancy||
4115|183|P|loss/abortion after the first 3 months, talk with your doctor||
4115|184|P|about reliable forms of birth control, and find out when it is||
4115|185|P|safe to start using birth control that contains a form of||
4115|186|P|estrogen, such as this medication.||
4115|187|P|   A small amount of this medication passes into breast milk and||
4115|188|P|may have undesirable effects on a nursing infant. Consult your||
4115|189|P|doctor before breastfeeding.||
4115|190|B|||
4115|191|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4115|192|I|medications work or increase your risk for serious side effects.||
4115|193|I|This document does not contain all possible drug interactions.||
4115|194|I|Keep a list of all the products you use (including||
4115|195|I|prescription/nonprescription drugs and herbal products) and share||
4115|196|I|it with your doctor and pharmacist. Do not start, stop, or change||
4115|197|I|the dosage of any medicines without your doctor's approval.||
4115|198|I|   Some products that may interact with this drug include:||
4115|199|I|aromatase inhibitors (such as anastrozole, exemestane),||
4115|200|I|fezolinetant, ospemifene, tamoxifen, tizanidine, tranexamic acid.||
4115|201|I|   Some drugs may cause hormonal birth control to work less well||
4115|202|I|by decreasing the amount of birth control hormones in your body.||
4115|203|I|This effect can result in pregnancy. Examples include||
4115|204|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
4115|205|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
4115|206|I|seizures (such as barbiturates, carbamazepine, felbamate,||
4115|207|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
4115|208|I|nevirapine), among others.||
4115|209|I|   Tell your doctor when you start any new drug, and discuss if||
4115|210|I|you should use reliable backup birth control. Also tell your||
4115|211|I|doctor if you have any new spotting or breakthrough bleeding,||
4115|212|I|because these may be signs that your birth control is not working||
4115|213|I|well.||
4115|214|I|   This medication may interfere with certain lab tests (such as||
4115|215|I|blood clotting factors, thyroid), possibly causing false test||
4115|216|I|results. Make sure lab personnel and all your doctors know you||
4115|217|I|use this drug.||
4115|218|B|||
4115|219|O|OVERDOSE:  This medication patch may be harmful if chewed or||
4115|220|O|swallowed. If someone has overdosed, remove the patch if||
4115|221|O|possible. For serious symptoms such as passing out or trouble||
4115|222|O|breathing, call 911. Otherwise, call a poison control center||
4115|223|O|right away. US residents can call 1-800-222-1222. Canada||
4115|224|O|residents can call 1-844-764-7669.||
4115|225|B|||
4115|226|N|NOTES:  Do not share this medication with others.||
4115|227|N|   Regular complete physical exams which include lab and/or||
4115|228|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
4115|229|N|Pap smear) should be done while you are using this medication.||
4115|230|N|Follow your doctor's instructions for examining your breasts, and||
4115|231|N|report any lumps right away. Keep all medical and lab||
4115|232|N|appointments. Consult your doctor for more details.||
4115|233|B|||
4115|234|D|MISSED DOSE:  If the patch comes off or if you forget to remove||
4115|235|D|it at the proper time, refer to the product package information||
4115|236|D|or How to Use section for instructions. You may need to use||
4115|237|D|backup birth control (such as condoms, spermicide) to prevent||
4115|238|D|pregnancy. Ask your doctor or pharmacist if you have any||
4115|239|D|questions.||
4115|240|D|   If you have trouble remembering to change your patch, or if||
4115|241|D|the patch often comes off, contact your doctor to discuss||
4115|242|D|switching to another form of birth control.||
4115|243|B|||
4115|244|R|STORAGE:  Store in the protective pouches at room temperature||
4115|245|R|away from light and moisture. Keep all medications away from||
4115|246|R|children and pets.||
4115|247|R|   Do not flush medications down the toilet or pour them into a||
4115|248|R|drain unless instructed to do so. Properly discard this product||
4115|249|R|when it is expired or no longer needed. (See also How to Use||
4115|250|R|section.)||
4115|251|B|||
4115|252|A|Information last revised October 2025.||
4115|253|A|Copyright(c) 2025 First Databank, Inc.||
4115|254|B|||
4123|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4123|002|Z|does NOT have all possible information about this product. This||
4123|003|Z|information does not assure that this product is safe, effective,||
4123|004|Z|or appropriate for you. This information is not individual||
4123|005|Z|medical advice and does not substitute for the advice of your||
4123|006|Z|health care professional. Always ask your health care||
4123|007|Z|professional for complete information about this product and your||
4123|008|Z|specific health needs.||
4123|009|B|||
4123|010|T|SODIUM BICARBONATE - ORAL||
4123|011|F|(SOE-dee-um bye-KAR-bo-nate)||
4123|012|B|||
4123|013|U|USES:  Sodium bicarbonate reduces stomach acid. It is used as an||
4123|014|U|antacid to treat heartburn, indigestion, and upset stomach.||
4123|015|U|Sodium bicarbonate is a very quick-acting antacid. It should be||
4123|016|U|used only for temporary relief. If you need to treat long-term||
4123|017|U|stomach acid problems (such as peptic ulcer disease, GERD), talk||
4123|018|U|with your doctor about other medications.||
4123|019|U|   Sodium bicarbonate is the active ingredient in baking soda.||
4123|020|B|||
4123|021|V|OTHER USES:  This section contains uses of this drug that are not||
4123|022|V|listed in the approved professional labeling for the drug but||
4123|023|V|that may be prescribed by your health care professional. Use this||
4123|024|V|drug for a condition that is listed in this section only if it||
4123|025|V|has been so prescribed by your health care professional.||
4123|026|V|   This drug may also be used to reduce the risk of gout and||
4123|027|V|kidney stones. It makes the urine less acidic, which helps the||
4123|028|V|kidneys get rid of uric acid. Uric acid can cause gout or kidney||
4123|029|V|stones. This drug can make some medications (such as||
4123|030|V|sulfonamides) work better or can help your body get rid of too||
4123|031|V|much medication (such as phenobarbital). This drug may also be||
4123|032|V|used for certain metabolic problems (such as acidosis) caused by||
4123|033|V|kidney disease.||
4123|034|B|||
4123|035|H|HOW TO USE:  Take this medication by mouth, usually every 4 hours||
4123|036|H|as needed or as directed by your doctor. Some tablets should be||
4123|037|H|dissolved in a glass of water before swallowing. Other tablets||
4123|038|H|may be swallowed whole or dissolved in water before swallowing.||
4123|039|H|Follow all directions on the product package for the product you||
4123|040|H|are taking. If you have any questions, ask your doctor or||
4123|041|H|pharmacist.||
4123|042|H|   If you are self-treating and your acid problems last or get||
4123|043|H|worse after you have used this product for 2 weeks, or if you||
4123|044|H|think you may have a serious medical problem, get medical help||
4123|045|H|right away. If you are using this medication regularly on a daily||
4123|046|H|basis for more than 2 weeks, you may have a medical problem that||
4123|047|H|needs different treatment. Ask your doctor if this is the right||
4123|048|H|medication for you.||
4123|049|H|   If your doctor has directed you to take this medication for||
4123|050|H|acidosis or to alkalinize your urine, your dosage is based on||
4123|051|H|your medical condition and response to treatment. To get the most||
4123|052|H|benefit from this medication, take it regularly, exactly as||
4123|053|H|directed. It is usually taken by mouth several times a day. To||
4123|054|H|help you remember, take it at the same times each day. Do not||
4123|055|H|increase the dose, take it more often, or keep taking this for||
4123|056|H|longer than prescribed.||
4123|057|B|||
4123|058|S|SIDE EFFECTS:  Nausea, bloating, or gas may occur. If any of||
4123|059|S|these effects last or get worse, tell your doctor or pharmacist||
4123|060|S|promptly.||
4123|061|S|   If your doctor has directed you to use this medication,||
4123|062|S|remember that your doctor has judged that the benefit to you is||
4123|063|S|greater than the risk of side effects. Many people using this||
4123|064|S|medication do not have serious side effects.||
4123|065|S|   Tell your doctor right away if you have any serious side||
4123|066|S|effects, including: swelling hands/ankles/feet, unusual weight||
4123|067|S|gain.||
4123|068|S|   When taken with sodium bicarbonate, large doses of calcium||
4123|069|S|from your diet, medications, or supplements can rarely cause a||
4123|070|S|serious problem called milk-alkali syndrome. Ask your doctor or||
4123|071|S|pharmacist about using calcium products safely while you are||
4123|072|S|using this medication. Tell your doctor right away if you have||
4123|073|S|any serious side effects, including: dizziness, muscle||
4123|074|S|aches/spasms, mental/mood changes (such as confusion,||
4123|075|S|irritability, memory problems), vomiting, weakness, signs of||
4123|076|S|kidney problems (such as change in the amount of urine).||
4123|077|S|   Get medical help right away if you have any very serious side||
4123|078|S|effects, including: chest pain, seizures.||
4123|079|S|   A very serious allergic reaction to this drug is rare.||
4123|080|S|However, get medical help right away if you notice any symptoms||
4123|081|S|of a serious allergic reaction, including: rash, itching/swelling||
4123|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4123|083|S|breathing.||
4123|084|S|   This is not a complete list of possible side effects. If you||
4123|085|S|notice other effects not listed above, contact your doctor or||
4123|086|S|pharmacist.||
4123|087|S|   In the US -||
4123|088|S|   Call your doctor for medical advice about side effects. You||
4123|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4123|090|S|www.fda.gov/medwatch.||
4123|091|S|   In Canada - Call your doctor for medical advice about side||
4123|092|S|effects. You may report side effects to Health Canada at||
4123|093|S|1-866-234-2345.||
4123|094|B|||
4123|095|P|PRECAUTIONS:  Before taking sodium bicarbonate, tell your doctor||
4123|096|P|or pharmacist if you are allergic to it; or if you have any other||
4123|097|P|allergies. This product may contain inactive ingredients, which||
4123|098|P|can cause allergic reactions or other problems. Talk to your||
4123|099|P|pharmacist for more details.||
4123|100|P|   Before using this medication, tell your doctor or pharmacist||
4123|101|P|your medical history, especially of: kidney problems, heart||
4123|102|P|failure, low calcium levels, swollen ankles/legs/feet due to||
4123|103|P|retaining water (peripheral edema).||
4123|104|P|   Because this medication contains salt (sodium), do not use it||
4123|105|P|if you are on a salt-restricted diet.||
4123|106|P|   Before having surgery, tell your doctor or dentist about all||
4123|107|P|the products you use (including prescription drugs,||
4123|108|P|nonprescription drugs, and herbal products).||
4123|109|P|   During pregnancy, this medication should be used only when||
4123|110|P|clearly needed. This medication may worsen high blood pressure||
4123|111|P|during pregnancy. Discuss the risks and benefits with your||
4123|112|P|doctor.||
4123|113|P|   This medication may pass into breast milk. Consult your doctor||
4123|114|P|before breastfeeding.||
4123|115|B|||
4123|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4123|117|I|medications work or increase your risk for serious side effects.||
4123|118|I|This document does not contain all possible drug interactions.||
4123|119|I|Keep a list of all the products you use (including||
4123|120|I|prescription/nonprescription drugs and herbal products) and share||
4123|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
4123|122|I|the dosage of any medicines without your doctor's approval.||
4123|123|I|   Antacids can interfere with the absorption of many other||
4123|124|I|drugs. Be sure to check with your pharmacist before taking||
4123|125|I|antacids with any other medication.||
4123|126|B|||
4123|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4123|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4123|129|O|poison control center right away. US residents can call||
4123|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4123|131|O|Symptoms of overdose may include: muscle spasms, seizures.||
4123|132|B|||
4123|133|N|NOTES:  Lab and/or medical tests (such as||
4123|134|N|calcium/potassium/sodium levels, bicarbonate levels) should be||
4123|135|N|done if you are taking large doses or taking this medication for||
4123|136|N|more than 2 weeks. Keep all medical and lab appointments. Consult||
4123|137|N|your doctor for more details.||
4123|138|B|||
4123|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4123|140|D|remember. If it is near the time of the next dose, skip the||
4123|141|D|missed dose. Take your next dose at the regular time. Do not||
4123|142|D|double the dose to catch up.||
4123|143|B|||
4123|144|R|STORAGE:  Store at room temperature away from light and moisture.||
4123|145|R|Do not store in the bathroom. Keep all medications away from||
4123|146|R|children and pets.||
4123|147|R|   Do not flush medications down the toilet or pour them into a||
4123|148|R|drain unless instructed to do so. Properly discard this product||
4123|149|R|when it is expired or no longer needed. Consult your pharmacist||
4123|150|R|or local waste disposal company.||
4123|151|B|||
4123|152|A|Information last revised October 2025.||
4123|153|A|Copyright(c) 2025 First Databank, Inc.||
4123|154|B|||
4125|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4125|002|Z|does NOT have all possible information about this product. This||
4125|003|Z|information does not assure that this product is safe, effective,||
4125|004|Z|or appropriate for you. This information is not individual||
4125|005|Z|medical advice and does not substitute for the advice of your||
4125|006|Z|health care professional. Always ask your health care||
4125|007|Z|professional for complete information about this product and your||
4125|008|Z|specific health needs.||
4125|009|B|||
4125|010|T|NEOMYCIN/GRAMICIDIN/NYSTATIN/TRIAMCINOLONE - TOPICAL||
4125|011|F|(nee-oh-MY-sin/gram-ih-SYE-din/NYE-stat-in/tri-am-SIN-oh-lone)||
4125|012|B|||
4125|013|U|USES:  This combination medication is used to treat skin||
4125|014|U|infections and to reduce symptoms (such as redness, irritation,||
4125|015|U|swelling, and itching) caused by the infection. Neomycin and||
4125|016|U|gramicidin are antibiotics that work by stopping the growth of||
4125|017|U|bacteria. Nystatin is an antifungal that works by slowing or||
4125|018|U|stopping the growth of fungi and yeasts. Triamcinolone is a||
4125|019|U|corticosteroid that helps reduce skin redness, swelling, and||
4125|020|U|itching.||
4125|021|B|||
4125|022|H|HOW TO USE:  This medication is for use on the skin only. Wash||
4125|023|H|your hands before using. Avoid getting this product in your eyes||
4125|024|H|or inside the mouth. If this occurs, wipe off the medication and||
4125|025|H|rinse thoroughly with water. Do not use inside the nose unless||
4125|026|H|directed by your doctor.||
4125|027|H|   Clean and dry the affected area as directed. Apply a small||
4125|028|H|amount of medication in a thin layer on the skin and rub in||
4125|029|H|gently as directed by your doctor, usually 2 to 3 times daily.||
4125|030|H|Wash your hands after use.||
4125|031|H|   Do not bandage, wrap, or cover the treated area unless you are||
4125|032|H|instructed to do so by your doctor. If this medication is applied||
4125|033|H|to the groin area, do not use tight-fitting plastic||
4125|034|H|pants/diapers/garments for incontinence (loss of control of your||
4125|035|H|bladder or bowels). Doing so may increase the absorption of this||
4125|036|H|product through the skin and increase the risk for side effects.||
4125|037|H|   Do not use large amounts of this medication, apply it more||
4125|038|H|often, or use it for a longer time than directed. Your condition||
4125|039|H|may not improve faster, and the risk for side effects may be||
4125|040|H|increased.||
4125|041|H|   Use this medication regularly in order to get the most benefit||
4125|042|H|from it. To help you remember, use it at the same times each day.||
4125|043|H|   Tell your doctor if your condition does not get better or if||
4125|044|H|it gets worse after 1 week.||
4125|045|B|||
4125|046|S|SIDE EFFECTS:  Burning, redness, irritation, or itching of the||
4125|047|S|skin may occur. If any of these effects last or get worse, tell||
4125|048|S|your doctor or pharmacist promptly.||
4125|049|S|   Remember that this medication has been prescribed because your||
4125|050|S|doctor has judged that the benefit to you is greater than the||
4125|051|S|risk of side effects. Many people using this medication do not||
4125|052|S|have serious side effects.||
4125|053|S|   Tell your doctor right away if you have any serious side||
4125|054|S|effects, including: acne, balance/hearing problems,||
4125|055|S|extreme/unwanted hair growth, small red bumps on the skin||
4125|056|S|(folliculitis), skin thinning/discoloration, stretch marks.||
4125|057|S|   Rarely, it is possible this medication will be absorbed from||
4125|058|S|the skin into the bloodstream. This can lead to side effects of||
4125|059|S|too much corticosteroid. These side effects are more likely in||
4125|060|S|children, and in people who use this medication for a long time||
4125|061|S|or over large areas of the skin. Tell your doctor right away if||
4125|062|S|any of the following side effects occur: unusual/extreme||
4125|063|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
4125|064|S|thirst/urination, vision problems.||
4125|065|S|   A very serious allergic reaction to this drug is rare.||
4125|066|S|However, get medical help right away if you notice any symptoms||
4125|067|S|of a serious allergic reaction, including: rash, itching/swelling||
4125|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4125|069|S|breathing.||
4125|070|S|   This is not a complete list of possible side effects. If you||
4125|071|S|notice other effects not listed above, contact your doctor or||
4125|072|S|pharmacist.||
4125|073|S|   In the US -||
4125|074|S|   Call your doctor for medical advice about side effects. You||
4125|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4125|076|S|www.fda.gov/medwatch.||
4125|077|S|   In Canada - Call your doctor for medical advice about side||
4125|078|S|effects. You may report side effects to Health Canada at||
4125|079|S|1-866-234-2345.||
4125|080|B|||
4125|081|P|PRECAUTIONS:  Before using this product, tell your doctor or||
4125|082|P|pharmacist if you are allergic to any of its ingredients; or if||
4125|083|P|you have any other allergies. This product may contain inactive||
4125|084|P|ingredients, which can cause allergic reactions or other||
4125|085|P|problems. Talk to your pharmacist for more details.||
4125|086|P|   This medication should not be used to treat an infection in||
4125|087|P|the outer ear canal if the eardrum is torn (perforated) or if the||
4125|088|P|inner ear is infected.||
4125|089|P|   Before using this medication, tell your doctor or pharmacist||
4125|090|P|your medical history, especially of: poor blood circulation, a||
4125|091|P|weakened immune system, other skin conditions (including eczema,||
4125|092|P|psoriasis, viral skin infections such as shingles, chickenpox,||
4125|093|P|cold sores), tuberculosis.||
4125|094|P|   Rarely, using corticosteroid medications for a long time or||
4125|095|P|over large areas of skin can make it more difficult for your body||
4125|096|P|to respond to physical stress. Before having surgery or emergency||
4125|097|P|treatment, or if you get a serious illness/injury, tell your||
4125|098|P|doctor or dentist that you are using this medication or have used||
4125|099|P|this medication within the past few months.||
4125|100|P|   Though it is unlikely, this medication may temporarily slow||
4125|101|P|down a child's growth if used for a long time. See the doctor||
4125|102|P|regularly so your child's height can be checked.||
4125|103|P|   During pregnancy, this medication should be used only when||
4125|104|P|clearly needed. Discuss the risks and benefits with your doctor||
4125|105|P|   It is unknown if this drug passes into breast milk. Consult||
4125|106|P|your doctor before breastfeeding.||
4125|107|B|||
4125|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4125|109|I|medications work or increase your risk for serious side effects.||
4125|110|I|This document does not contain all possible drug interactions.||
4125|111|I|Keep a list of all the products you use (including||
4125|112|I|prescription/nonprescription drugs and herbal products) and share||
4125|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
4125|114|I|the dosage of any medicines without your doctor's approval.||
4125|115|I|   Some products that may interact with this drug are:||
4125|116|I|aminoglycoside antibiotics (such as gentamicin, tobramycin).||
4125|117|B|||
4125|118|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
4125|119|O|has overdosed and has serious symptoms such as passing out or||
4125|120|O|trouble breathing, call 911. Otherwise, call a poison control||
4125|121|O|center right away. US residents can call 1-800-222-1222. Canada||
4125|122|O|residents can call 1-844-764-7669.||
4125|123|B|||
4125|124|N|NOTES:  Do not share this medication with others.||
4125|125|N|   Lab and/or medical tests (such as adrenal gland function) may||
4125|126|N|be done while you are using this medication, especially if you||
4125|127|N|use this drug for an extended period of time or apply it over||
4125|128|N|large areas of the body. Keep all medical and lab appointments.||
4125|129|N|Consult your doctor for more details.||
4125|130|N|   This medication has been prescribed for your current condition||
4125|131|N|only. Do not use it later for another infection unless your||
4125|132|N|doctor tells you to.||
4125|133|B|||
4125|134|D|MISSED DOSE:  If you miss a dose, apply the medication as soon as||
4125|135|D|you remember. If it is near the time of the next dose, skip the||
4125|136|D|missed dose. Use your next dose at the regular time. Do not apply||
4125|137|D|more than the usual amount to make up for the missed dose.||
4125|138|B|||
4125|139|R|STORAGE:  Store at room temperature. Keep all medications away||
4125|140|R|from children and pets.||
4125|141|R|   Do not flush medications down the toilet or pour them into a||
4125|142|R|drain unless instructed to do so. Properly discard this product||
4125|143|R|when it is expired or no longer needed. Consult your pharmacist||
4125|144|R|or local waste disposal company.||
4125|145|B|||
4125|146|A|Information last revised November 2024.||
4125|147|A|Copyright(c) 2025 First Databank, Inc.||
4125|148|B|||
4128|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4128|002|Z|does NOT have all possible information about this product. This||
4128|003|Z|information does not assure that this product is safe, effective,||
4128|004|Z|or appropriate for you. This information is not individual||
4128|005|Z|medical advice and does not substitute for the advice of your||
4128|006|Z|health care professional. Always ask your health care||
4128|007|Z|professional for complete information about this product and your||
4128|008|Z|specific health needs.||
4128|009|B|||
4128|010|T|PYRIMETHAMINE - ORAL||
4128|011|F|(pir-ih-METH-uh-meen)||
4128|012|B|||
4128|013|C|COMMON BRAND NAME(S): Daraprim||
4128|014|B|||
4128|015|U|USES:  This medication is used with other medication (such as a||
4128|016|U|sulfonamide) to treat a serious parasite infection||
4128|017|U|(toxoplasmosis) of the body, brain, or eye or to prevent||
4128|018|U|toxoplasmosis infection in people with HIV infection.||
4128|019|U|Pyrimethamine belongs to a class of drugs known as||
4128|020|U|antiparasitics. It works by killing parasites.||
4128|021|B|||
4128|022|V|OTHER USES:  This section contains uses of this drug that are not||
4128|023|V|listed in the approved professional labeling for the drug but||
4128|024|V|that may be prescribed by your health care professional. Use this||
4128|025|V|drug for a condition that is listed in this section only if it||
4128|026|V|has been so prescribed by your health care professional.||
4128|027|V|   This drug may also be used with other medications (such as||
4128|028|V|dapsone) for pneumocystis pneumonia in people with AIDS.||
4128|029|B|||
4128|030|H|HOW TO USE:  Take this medication by mouth as directed by your||
4128|031|H|doctor, usually once or twice daily. Take this medication with||
4128|032|H|food to decrease nausea and vomiting. If vomiting is severe or||
4128|033|H|continues, your doctor may lower your dose or direct you to stop||
4128|034|H|taking this medication. Your doctor will prescribe another||
4128|035|H|medication (folic/folinic acid) to prevent blood problems caused||
4128|036|H|by pyrimethamine. Follow your doctor's directions carefully.||
4128|037|H|Drink plenty of fluids to prevent kidney problems if you are||
4128|038|H|taking a "sulfa" medication with pyrimethamine.||
4128|039|H|   This medication works best when the amount of drug in your||
4128|040|H|body is kept at a constant level. Take this drug and other||
4128|041|H|antiparasitic drugs regularly, exactly as prescribed by your||
4128|042|H|doctor. To help you remember, take it at the same time(s) each||
4128|043|H|day.||
4128|044|H|   The dosage is based on the type of infection, your medical||
4128|045|H|condition, age, and response to treatment. The length of time you||
4128|046|H|will take this medication depends on your infection. Your dose||
4128|047|H|must be carefully adjusted by your doctor to treat your infection||
4128|048|H|and prevent serious side effects. Follow your doctor's directions||
4128|049|H|carefully.||
4128|050|H|   Do not take more or less of this drug than prescribed. Do not||
4128|051|H|stop taking it before completing this prescription unless||
4128|052|H|directed to do so by your doctor, even if you feel better.||
4128|053|H|Skipping or changing your dose without approval from your doctor||
4128|054|H|may cause the amount of parasites to increase, make the infection||
4128|055|H|more difficult to treat (resistant), or worsen side effects.||
4128|056|H|   Tell your doctor if your condition lasts or gets worse.||
4128|057|B|||
4128|058|S|SIDE EFFECTS:  See also How to Use section.||
4128|059|S|   Nausea, vomiting, and loss of appetite may occur. If any of||
4128|060|S|these effects last or get worse, tell your doctor or pharmacist||
4128|061|S|promptly.||
4128|062|S|   Remember that this medication has been prescribed because your||
4128|063|S|doctor has judged that the benefit to you is greater than the||
4128|064|S|risk of side effects. Many people using this medication do not||
4128|065|S|have serious side effects.||
4128|066|S|   Some people using this medication may develop serious side||
4128|067|S|effects including blood problems, especially at higher doses.||
4128|068|S|This risk can be reduced with the use of folic/folinic acid and||
4128|069|S|regular blood tests. Tell your doctor right away if you have any||
4128|070|S|serious side effects, including: easy bruising/bleeding, signs of||
4128|071|S|infection (such as sore throat that doesn't go away, fever,||
4128|072|S|chills), signs of low red blood cell count (such as unusual||
4128|073|S|tiredness, pale lips/nails/skin, fast heartbeat, rapid||
4128|074|S|breathing), swollen/painful tongue.||
4128|075|S|   Get medical help right away if you have any very serious side||
4128|076|S|effects, including: bloody/pink urine, chest pain,||
4128|077|S|slow/fast/irregular heartbeat.||
4128|078|S|   A very serious allergic reaction to this drug is rare.||
4128|079|S|However, get medical help right away if you notice any symptoms||
4128|080|S|of a serious allergic reaction, including: rash, itching/swelling||
4128|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4128|082|S|breathing.||
4128|083|S|   This is not a complete list of possible side effects. If you||
4128|084|S|notice other effects not listed above, contact your doctor or||
4128|085|S|pharmacist.||
4128|086|S|   In the US -||
4128|087|S|   Call your doctor for medical advice about side effects. You||
4128|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4128|089|S|www.fda.gov/medwatch.||
4128|090|S|   In Canada - Call your doctor for medical advice about side||
4128|091|S|effects. You may report side effects to Health Canada at||
4128|092|S|1-866-234-2345.||
4128|093|B|||
4128|094|P|PRECAUTIONS:  Before taking pyrimethamine, tell your doctor or||
4128|095|P|pharmacist if you are allergic to it; or if you have any other||
4128|096|P|allergies. This product may contain inactive ingredients, which||
4128|097|P|can cause allergic reactions or other problems. Talk to your||
4128|098|P|pharmacist for more details.||
4128|099|P|   Before using this medication, tell your doctor or pharmacist||
4128|100|P|your medical history, especially of: seizures, kidney problems,||
4128|101|P|liver problems, a certain type of low red blood cell count||
4128|102|P|(megaloblastic anemia due to low blood folate), low folic acid||
4128|103|P|levels from other conditions (such as malnutrition, problems with||
4128|104|P|absorption of food, alcoholism), low red/white blood cell counts,||
4128|105|P|low blood-clotting cell (platelet) count.||
4128|106|P|   Before having surgery, tell your doctor or dentist about all||
4128|107|P|the products you use (including prescription drugs,||
4128|108|P|nonprescription drugs, and herbal products).||
4128|109|P|   During pregnancy, this medication should be used only when||
4128|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
4128|111|P|Folic acid is very important during pregnancy. Your doctor will||
4128|112|P|prescribe folic/folinic acid to prevent low folate levels.||
4128|113|P|   This medication passes into breast milk. Consult your doctor||
4128|114|P|before breastfeeding.||
4128|115|B|||
4128|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4128|117|I|medications work or increase your risk for serious side effects.||
4128|118|I|This document does not contain all possible drug interactions.||
4128|119|I|Keep a list of all the products you use (including||
4128|120|I|prescription/nonprescription drugs and herbal products) and share||
4128|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
4128|122|I|the dosage of any medicines without your doctor's approval.||
4128|123|I|   Some products that may interact with this drug include:||
4128|124|I|lorazepam, penicillamine, sulfa drugs (such as sulfamethoxazole),||
4128|125|I|drugs that can lower folate levels (such as phenytoin,||
4128|126|I|trimethoprim), drugs that can lower blood counts (such as||
4128|127|I|proguanil, zidovudine, chemotherapy including daunorubicin,||
4128|128|I|cytosine).||
4128|129|I|   This medication can slow down the removal of other medications||
4128|130|I|from your body, which may affect how they work. An example of an||
4128|131|I|affected drug is dofetilide, among others.||
4128|132|B|||
4128|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4128|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4128|135|O|poison control center right away. US residents can call||
4128|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4128|137|O|Symptoms of overdose may include: abdominal pain, severe/repeated||
4128|138|O|vomiting, vomiting blood, seizures, slow/shallow breathing,||
4128|139|O|inability to wake up.||
4128|140|B|||
4128|141|N|NOTES:  Do not share this medication with others.||
4128|142|N|   Lab and/or medical tests (such as complete blood count, liver||
4128|143|N|function) should be done while you are taking this medication.||
4128|144|N|Keep all medical and lab appointments. Consult your doctor for||
4128|145|N|more details.||
4128|146|B|||
4128|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4128|148|D|remember. If it is near the time of the next dose, skip the||
4128|149|D|missed dose. Take your next dose at the regular time. Do not||
4128|150|D|double the dose to catch up.||
4128|151|B|||
4128|152|R|STORAGE:  Store at room temperature away from light and moisture.||
4128|153|R|Do not store in the bathroom. Keep all medications away from||
4128|154|R|children and pets.||
4128|155|R|   Do not flush medications down the toilet or pour them into a||
4128|156|R|drain unless instructed to do so. Properly discard this product||
4128|157|R|when it is expired or no longer needed. Consult your pharmacist||
4128|158|R|or local waste disposal company.||
4128|159|B|||
4128|160|A|Information last revised August 2025.||
4128|161|A|Copyright(c) 2025 First Databank, Inc.||
4128|162|B|||
4132|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4132|002|Z|does NOT have all possible information about this product. This||
4132|003|Z|information does not assure that this product is safe, effective,||
4132|004|Z|or appropriate for you. This information is not individual||
4132|005|Z|medical advice and does not substitute for the advice of your||
4132|006|Z|health care professional. Always ask your health care||
4132|007|Z|professional for complete information about this product and your||
4132|008|Z|specific health needs.||
4132|009|B|||
4132|010|T|GRANISETRON - INJECTION||
4132|011|F|(gra-NIS-e-tron)||
4132|012|B|||
4132|013|C|COMMON BRAND NAME(S): Kytril||
4132|014|B|||
4132|015|U|USES:  This medication is used alone or with other medications to||
4132|016|U|prevent nausea and vomiting caused by cancer drug treatment||
4132|017|U|(chemotherapy). It is also used to prevent and treat nausea and||
4132|018|U|vomiting after surgery in adults.||
4132|019|U|   Granisetron works by blocking one of the body's natural||
4132|020|U|substances (serotonin) that can cause vomiting.||
4132|021|B|||
4132|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4132|023|H|from your pharmacist before you start using granisetron and each||
4132|024|H|time you get a refill. If you have any questions, ask your doctor||
4132|025|H|or pharmacist.||
4132|026|H|   This drug is given into a vein as directed by your doctor,||
4132|027|H|usually 30 minutes before cancer chemotherapy or||
4132|028|H|before/during/after surgery. The drug may be given directly into||
4132|029|H|a vein over 30 seconds, or it may be mixed in an IV fluid and||
4132|030|H|given into a vein over a longer time (5 minutes).||
4132|031|H|   If you are giving this medication to yourself at home, learn||
4132|032|H|all preparation and usage instructions from your health care||
4132|033|H|professional. Before using, check this product for particles or||
4132|034|H|discoloration. If either is present, do not use the liquid. Learn||
4132|035|H|how to store and discard medical supplies safely.||
4132|036|H|   Do not mix granisetron with other drugs in the same injection||
4132|037|H|or inject other drugs into the same vein at the same time. If you||
4132|038|H|have questions about using this medication properly, consult your||
4132|039|H|pharmacist.||
4132|040|H|   Dosage is based on your medical condition and response to||
4132|041|H|treatment. The dosage may also be based on weight. Use this||
4132|042|H|medication exactly as directed to get the most benefit from it.||
4132|043|H|Do not use more medication or use it more often than prescribed.||
4132|044|H|Ask your doctor or pharmacist if you have questions.||
4132|045|H|   Tell your doctor if your nausea does not get better or if it||
4132|046|H|gets worse.||
4132|047|B|||
4132|048|S|SIDE EFFECTS:  Headache, diarrhea, dizziness, fever, or||
4132|049|S|pain/redness/swelling at the injection site may occur. If any of||
4132|050|S|these effects last or get worse, tell your doctor promptly.||
4132|051|S|   Remember that this medication has been prescribed because your||
4132|052|S|doctor has judged that the benefit to you is greater than the||
4132|053|S|risk of side effects. Many people using this medication do not||
4132|054|S|have serious side effects.||
4132|055|S|   Tell your doctor right away if you have any serious side||
4132|056|S|effects, including: stomach/abdominal pain.||
4132|057|S|   Get medical help right away if you have any very serious side||
4132|058|S|effects, including: chest pain, fast/irregular heartbeat, severe||
4132|059|S|dizziness, fainting.||
4132|060|S|   This medication may increase serotonin and rarely cause a very||
4132|061|S|serious condition called serotonin syndrome/toxicity. The risk||
4132|062|S|increases if you are also taking other drugs that increase||
4132|063|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
4132|064|S|take (see Drug Interactions section). Get medical help right away||
4132|065|S|if you develop some of the following symptoms: fast heartbeat,||
4132|066|S|hallucinations, loss of coordination, severe dizziness, severe||
4132|067|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
4132|068|S|unusual agitation/restlessness.||
4132|069|S|   A very serious allergic reaction to this drug is rare.||
4132|070|S|However, get medical help right away if you notice any symptoms||
4132|071|S|of a serious allergic reaction, including: rash, itching/swelling||
4132|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4132|073|S|breathing.||
4132|074|S|   This is not a complete list of possible side effects. If you||
4132|075|S|notice other effects not listed above, contact your doctor or||
4132|076|S|pharmacist.||
4132|077|S|   In the US -||
4132|078|S|   Call your doctor for medical advice about side effects. You||
4132|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4132|080|S|www.fda.gov/medwatch.||
4132|081|S|   In Canada - Call your doctor for medical advice about side||
4132|082|S|effects. You may report side effects to Health Canada at||
4132|083|S|1-866-234-2345.||
4132|084|B|||
4132|085|P|PRECAUTIONS:  Before using granisetron, tell your doctor or||
4132|086|P|pharmacist if you are allergic to it; or to other anti-nausea||
4132|087|P|serotonin blockers (such as dolasetron, ondansetron); or if you||
4132|088|P|have any other allergies. This product may contain inactive||
4132|089|P|ingredients, which can cause allergic reactions or other||
4132|090|P|problems. Talk to your pharmacist for more details.||
4132|091|P|   Before using this medication, tell your doctor or pharmacist||
4132|092|P|your medical history, especially of: stomach/intestinal problems||
4132|093|P|(such as recent surgery, ileus, swelling).||
4132|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4132|095|P|can make you more dizzy. Do not drive, use machinery, or do||
4132|096|P|anything that needs alertness until you can do it safely. Avoid||
4132|097|P|alcoholic beverages. Talk to your doctor if you are using||
4132|098|P|marijuana (cannabis).||
4132|099|P|   Granisetron may cause a condition that affects the heart||
4132|100|P|rhythm (QT prolongation). QT prolongation can rarely cause||
4132|101|P|serious (rarely fatal) fast/irregular heartbeat and other||
4132|102|P|symptoms (such as severe dizziness, fainting) that need medical||
4132|103|P|attention right away.||
4132|104|P|   The risk of QT prolongation may be increased if you have||
4132|105|P|certain medical conditions or are taking other drugs that may||
4132|106|P|cause QT prolongation. Before using granisetron, tell your doctor||
4132|107|P|or pharmacist of all the drugs you take and if you have any of||
4132|108|P|the following conditions: certain heart problems (heart failure,||
4132|109|P|slow heartbeat, QT prolongation in the EKG), family history of||
4132|110|P|certain heart problems (QT prolongation in the EKG, sudden||
4132|111|P|cardiac death).||
4132|112|P|   Low levels of potassium or magnesium in the blood may also||
4132|113|P|increase your risk of QT prolongation. This risk may increase if||
4132|114|P|you use certain drugs (such as diuretics/"water pills") or if you||
4132|115|P|have conditions such as severe sweating, diarrhea, or vomiting.||
4132|116|P|Talk to your doctor about using granisetron safely.||
4132|117|P|   Older adults may be more sensitive to the side effects of this||
4132|118|P|drug, especially QT prolongation (see above).||
4132|119|P|   During pregnancy, this medication should be used only when||
4132|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
4132|121|P|   It is unknown if this drug passes into breast milk. Consult||
4132|122|P|your doctor before breastfeeding.||
4132|123|B|||
4132|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4132|125|I|medications work or increase your risk for serious side effects.||
4132|126|I|This document does not contain all possible drug interactions.||
4132|127|I|Keep a list of all the products you use (including||
4132|128|I|prescription/nonprescription drugs and herbal products) and share||
4132|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
4132|130|I|the dosage of any medicines without your doctor's approval.||
4132|131|I|   A product that may interact with this drug is: apomorphine.||
4132|132|I|   Many drugs besides granisetron may affect the heart rhythm (QT||
4132|133|I|prolongation), including amiodarone, dofetilide, pimozide,||
4132|134|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
4132|135|I|erythromycin), among others.||
4132|136|I|   The risk of serotonin syndrome/toxicity increases if you are||
4132|137|I|also taking other drugs that increase serotonin. Examples include||
4132|138|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
4132|139|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
4132|140|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
4132|141|I|serotonin syndrome/toxicity may be more likely when you start or||
4132|142|I|increase the dose of these drugs.||
4132|143|B|||
4132|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4132|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4132|146|O|poison control center right away. US residents can call||
4132|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4132|148|B|||
4132|149|N|NOTES:  Do not share this medication with others.||
4132|150|B|||
4132|151|D|MISSED DOSE:  Tell your doctor if you miss your dose or did not||
4132|152|D|use your dose at the correct time before your scheduled||
4132|153|D|chemotherapy appointment or surgery. Your treatment or surgery||
4132|154|D|may need to be rescheduled.||
4132|155|B|||
4132|156|R|STORAGE:  Consult the product instructions and your pharmacist||
4132|157|R|for storage details. Keep all medications away from children and||
4132|158|R|pets.||
4132|159|R|   Do not flush medications down the toilet or pour them into a||
4132|160|R|drain unless instructed to do so. Properly discard this product||
4132|161|R|when it is expired or no longer needed. Consult your pharmacist||
4132|162|R|or local waste disposal company.||
4132|163|B|||
4132|164|A|Information last revised November 2024.||
4132|165|A|Copyright(c) 2025 First Databank, Inc.||
4132|166|B|||
4133|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4133|002|Z|does NOT have all possible information about this product. This||
4133|003|Z|information does not assure that this product is safe, effective,||
4133|004|Z|or appropriate for you. This information is not individual||
4133|005|Z|medical advice and does not substitute for the advice of your||
4133|006|Z|health care professional. Always ask your health care||
4133|007|Z|professional for complete information about this product and your||
4133|008|Z|specific health needs.||
4133|009|B|||
4133|010|T|METHOTREXATE - INJECTION||
4133|011|F|(meth-oh-TREX-ate)||
4133|012|B|||
4133|013|C|COMMON BRAND NAME(S): Abitrexate||
4133|014|B|||
4133|015|W|WARNING:  Methotrexate has rarely caused serious (sometimes||
4133|016|W|fatal) side effects. This medication should be used only to treat||
4133|017|W|cancer or severe diseases caused by an overactive immune system||
4133|018|W|(such as psoriasis, rheumatoid arthritis).||
4133|019|W|   Methotrexate formulations with preservatives must not be used||
4133|020|W|for high-dose treatment or injected into the area around the||
4133|021|W|spinal cord (intrathecal).||
4133|022|W|   Methotrexate has caused birth defects and death in unborn||
4133|023|W|babies. Women must avoid becoming pregnant while using this||
4133|024|W|medication. Pregnant women who have psoriasis or rheumatoid||
4133|025|W|arthritis must not use methotrexate. (See also Precautions||
4133|026|W|section.)||
4133|027|W|   If you have kidney problems or excess body water (ascites,||
4133|028|W|pleural effusion), you must be closely monitored and your dose||
4133|029|W|may be adjusted or stopped by your doctor.||
4133|030|W|   Methotrexate (usually at high dosages) has rarely caused||
4133|031|W|severe (sometimes fatal) blood/bone marrow problems (decreasing||
4133|032|W|your body's ability to fight infections) and stomach/intestinal||
4133|033|W|disease (such as bleeding) when used at the same time as||
4133|034|W|non-steroidal anti-inflammatory drugs (NSAIDs such as||
4133|035|W|indomethacin, ketoprofen). NSAIDs should not be used with||
4133|036|W|high-dose methotrexate. Caution is advised if you also take||
4133|037|W|aspirin. NSAIDs/aspirin may be used with low-dose methotrexate||
4133|038|W|such as for the treatment of rheumatoid arthritis if directed by||
4133|039|W|your doctor. If your doctor has told you to take low-dose aspirin||
4133|040|W|to prevent heart attack or stroke (usually 81-162 milligrams a||
4133|041|W|day), you should keep taking the aspirin unless your doctor tells||
4133|042|W|you not to. Ask your doctor or pharmacist for more details on the||
4133|043|W|safe use of these drugs (such as close monitoring by your doctor,||
4133|044|W|keeping the same doses of NSAIDs).||
4133|045|W|   In rare instances, this drug may also cause liver problems||
4133|046|W|when it is used for long periods of time. If you are using||
4133|047|W|methotrexate long term, a liver biopsy is usually recommended.||
4133|048|W|   Methotrexate use has rarely caused serious (sometimes fatal)||
4133|049|W|side effects, such as lung problems, lung infections||
4133|050|W|(Pneumocystis jiroveci pneumonia), skin reactions, diarrhea, and||
4133|051|W|mouth sores (ulcerative stomatitis). (See also Side Effects||
4133|052|W|section.)||
4133|053|W|   Lumps (tumors/abnormal growths) may very rarely appear during||
4133|054|W|methotrexate use. The drug must be stopped and treatment may be||
4133|055|W|needed. Tell your doctor right away if new lumps/growths occur.||
4133|056|W|   When used to treat tumors, methotrexate sometimes causes side||
4133|057|W|effects due to the rapid destruction of cancer cells (tumor lysis||
4133|058|W|syndrome). To lower your risk, drink plenty of fluids unless your||
4133|059|W|doctor directs you otherwise. Also, your doctor may prescribe an||
4133|060|W|additional medication. Tell your doctor right away if you have||
4133|061|W|symptoms such as irregular heartbeat, low back/side pain, signs||
4133|062|W|of kidney problems (such as pink/bloody urine, change in the||
4133|063|W|amount of urine, painful urination), or muscle spasms/weakness.||
4133|064|W|   When this medication is used with radiation treatment, it may||
4133|065|W|rarely increase the risk of tissue and bone damage. Discuss the||
4133|066|W|risks and benefits of your treatment with your doctor.||
4133|067|B|||
4133|068|U|USES:  Methotrexate is used to treat certain types of cancer,||
4133|069|U|severe psoriasis, or rheumatoid arthritis. It may also be used to||
4133|070|U|treat a certain type of arthritis in children (polyarticular||
4133|071|U|juvenile idiopathic arthritis - pJIA). Methotrexate belongs to a||
4133|072|U|class of drugs known as antimetabolites. It works by slowing or||
4133|073|U|stopping the growth of cancer cells and blocking the immune||
4133|074|U|system from attacking healthy tissue.||
4133|075|U|   Early treatment of rheumatoid arthritis with methotrexate||
4133|076|U|helps to reduce further joint damage and to preserve joint||
4133|077|U|function.||
4133|078|B|||
4133|079|V|OTHER USES:  This section contains uses of this drug that are not||
4133|080|V|listed in the approved professional labeling for the drug but||
4133|081|V|that may be prescribed by your health care professional. Use this||
4133|082|V|drug for a condition that is listed in this section only if it||
4133|083|V|has been so prescribed by your health care professional.||
4133|084|V|   This medication may also be used for lupus, psoriatic||
4133|085|V|arthritis, Crohn's disease, and ectopic pregnancy.||
4133|086|B|||
4133|087|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4133|088|H|from your pharmacist before you start using methotrexate and each||
4133|089|H|time you get a refill. If you have any questions, ask your doctor||
4133|090|H|or pharmacist.||
4133|091|H|   This medication is given by injection as directed by your||
4133|092|H|doctor. The dosage, method of injection, and how often you||
4133|093|H|receive this medication are based on your medical condition and||
4133|094|H|response to treatment. For the treatment of rheumatoid arthritis||
4133|095|H|or psoriasis, this medication is given by injection as directed||
4133|096|H|by your doctor, usually once a week.||
4133|097|H|   For some conditions (such as rheumatoid arthritis), you may be||
4133|098|H|taught to give yourself injections at home. In this case, learn||
4133|099|H|all preparation and usage instructions from your health care||
4133|100|H|professional. If you have any questions, ask your health care||
4133|101|H|professional.||
4133|102|H|   Before using, check this product for particles or||
4133|103|H|discoloration. If either is present, do not use the liquid.||
4133|104|H|   Learn how to store and discard medical supplies safely.||
4133|105|B|||
4133|106|S|SIDE EFFECTS:  See also Warning section.||
4133|107|S|   Nausea, vomiting, stomach pain, drowsiness, or dizziness may||
4133|108|S|occur. If any of these effects last or get worse, tell your||
4133|109|S|doctor or pharmacist promptly.||
4133|110|S|   Temporary hair loss may occur. Normal hair growth should||
4133|111|S|return after treatment has ended.||
4133|112|S|   Remember that this medication has been prescribed because your||
4133|113|S|doctor has judged that the benefit to you is greater than the||
4133|114|S|risk of side effects. Many people using this medication do not||
4133|115|S|have serious side effects.||
4133|116|S|   Tell your doctor right away if you have any serious side||
4133|117|S|effects, including: mouth sores, diarrhea, signs of anemia (such||
4133|118|S|as unusual tiredness, pale skin), signs of liver problems (such||
4133|119|S|as nausea/vomiting that doesn't stop, dark urine,||
4133|120|S|stomach/abdominal pain, yellowing eyes/skin), easy||
4133|121|S|bruising/bleeding, black stools, swollen lymph nodes, bone pain,||
4133|122|S|unusual pain and discoloration of the skin, signs of kidney||
4133|123|S|problems (such as change in the amount of urine), dry cough,||
4133|124|S|muscle weakness.||
4133|125|S|   Get medical help right away if you have any very serious side||
4133|126|S|effects, including: irregular heartbeat, vision changes, weakness||
4133|127|S|on one side of the body, severe headache, neck stiffness,||
4133|128|S|mental/mood changes, seizures.||
4133|129|S|   This medication may lower your ability to fight infections.||
4133|130|S|This may make you more likely to get a serious (rarely fatal)||
4133|131|S|infection or make any infection you have worse. Tell your doctor||
4133|132|S|right away if you have any signs of infection (such as sore||
4133|133|S|throat that doesn't go away, fever, chills).||
4133|134|S|   A very serious allergic reaction to this drug is rare.||
4133|135|S|However, get medical help right away if you notice any symptoms||
4133|136|S|of a serious allergic reaction, including: rash, itching/swelling||
4133|137|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4133|138|S|breathing.||
4133|139|S|   This is not a complete list of possible side effects. If you||
4133|140|S|notice other effects not listed above, contact your doctor or||
4133|141|S|pharmacist.||
4133|142|S|   In the US -||
4133|143|S|   Call your doctor for medical advice about side effects. You||
4133|144|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4133|145|S|www.fda.gov/medwatch.||
4133|146|S|   In Canada - Call your doctor for medical advice about side||
4133|147|S|effects. You may report side effects to Health Canada at||
4133|148|S|1-866-234-2345.||
4133|149|B|||
4133|150|P|PRECAUTIONS:  See also Warning section.||
4133|151|P|   Before using methotrexate, tell your doctor or pharmacist if||
4133|152|P|you are allergic to it; or if you have any other allergies. This||
4133|153|P|product may contain inactive ingredients, which can cause||
4133|154|P|allergic reactions or other problems. Talk to your pharmacist for||
4133|155|P|more details.||
4133|156|P|   Before using this medication, tell your doctor or pharmacist||
4133|157|P|your medical history, especially of: liver disease, kidney||
4133|158|P|disease, lung disease (such as pulmonary fibrosis), alcohol use,||
4133|159|P|suppressed immune system, blood cell/bone marrow disorders,||
4133|160|P|stomach/intestinal diseases (such as peptic ulcer, ulcerative||
4133|161|P|colitis), any active infection (including chickenpox or recent||
4133|162|P|exposure to it), folic acid deficiency.||
4133|163|P|   Methotrexate can make you more likely to get infections or may||
4133|164|P|make current infections worse. Stay away from anyone who has an||
4133|165|P|infection that may easily spread (such as chickenpox, COVID-19,||
4133|166|P|measles, flu). Talk to your doctor if you have been exposed to an||
4133|167|P|infection or for more details.||
4133|168|P|   Tell your health care professional that you are using||
4133|169|P|methotrexate before having any immunizations/vaccinations. Avoid||
4133|170|P|contact with people who have recently received live vaccines||
4133|171|P|(such as flu vaccine inhaled through the nose).||
4133|172|P|   To lower the chance of getting cut, bruised, or injured, use||
4133|173|P|caution with sharp objects like razors and nail cutters, and||
4133|174|P|avoid activities such as contact sports.||
4133|175|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4133|176|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4133|177|P|machinery, or do anything that needs alertness until you can do||
4133|178|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
4133|179|P|are using marijuana (cannabis).||
4133|180|P|   Before having surgery, tell your doctor or dentist about all||
4133|181|P|the products you use (including prescription drugs,||
4133|182|P|nonprescription drugs, and herbal products).||
4133|183|P|   Children may be more sensitive to the side effects of this||
4133|184|P|drug, especially seizures.||
4133|185|P|   This medication may make you more sensitive to the sun. Limit||
4133|186|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4133|187|P|sunscreen and wear protective clothing when outdoors. Tell your||
4133|188|P|doctor right away if you get sunburned or have skin||
4133|189|P|blisters/redness.||
4133|190|P|   This medication can affect fertility in both males and||
4133|191|P|females. Ask your doctor for more details.||
4133|192|P|   Methotrexate must not be used during pregnancy. It may harm an||
4133|193|P|unborn baby. Your doctor should order a pregnancy test before you||
4133|194|P|start this medication. You should not become pregnant while using||
4133|195|P|methotrexate. Women using this medication should ask about||
4133|196|P|reliable forms of birth control during treatment and for 6 months||
4133|197|P|after the last dose. Men using this medication should ask about||
4133|198|P|reliable forms of birth control during treatment and for 3 months||
4133|199|P|after the last dose. If you or your partner become pregnant, or||
4133|200|P|think you are pregnant, talk to your doctor right away about the||
4133|201|P|risks and benefits of this medication.||
4133|202|P|   Methotrexate passes into breast milk and may harm a nursing||
4133|203|P|infant. Breastfeeding is not recommended while using this||
4133|204|P|medication and for at least 1 week after the last dose. Consult||
4133|205|P|your doctor before breastfeeding.||
4133|206|B|||
4133|207|I|DRUG INTERACTIONS:  See also Warning section.||
4133|208|I|   Drug interactions may change how your medications work or||
4133|209|I|increase your risk for serious side effects. This document does||
4133|210|I|not contain all possible drug interactions. Keep a list of all||
4133|211|I|the products you use (including prescription/nonprescription||
4133|212|I|drugs and herbal products) and share it with your doctor and||
4133|213|I|pharmacist. Do not start, stop, or change the dosage of any||
4133|214|I|medicines without your doctor's approval.||
4133|215|I|   Some products that may interact with this drug include:||
4133|216|I|acitretin, asparaginase, leflunomide.||
4133|217|I|   Other medications can affect the removal of methotrexate from||
4133|218|I|your body, which may affect how methotrexate works. Examples||
4133|219|I|include penicillins, probenecid, proton pump inhibitors-PPIs||
4133|220|I|(such as esomeprazole, omeprazole, pantoprazole), sulfa||
4133|221|I|medications, among others.||
4133|222|B|||
4133|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4133|224|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4133|225|O|poison control center right away. US residents can call||
4133|226|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4133|227|O|Symptoms of overdose may include severe nausea and vomiting, and||
4133|228|O|bloody stools.||
4133|229|B|||
4133|230|N|NOTES:  Do not share this medication with others.||
4133|231|N|   Lab and/or medical tests (such as complete blood cell counts,||
4133|232|N|liver/kidney function, pregnancy test, chest X-ray) should be||
4133|233|N|done before you start using this medication and while you are||
4133|234|N|using it. Keep all medical and lab appointments. Consult your||
4133|235|N|doctor for more details.||
4133|236|B|||
4133|237|D|MISSED DOSE:  It is important to get each dose of this medication||
4133|238|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
4133|239|D|right away for a new dosing schedule. Do not double the dose to||
4133|240|D|catch up.||
4133|241|B|||
4133|242|R|STORAGE:  Consult the product instructions and your pharmacist||
4133|243|R|for storage details. Keep all medications away from children and||
4133|244|R|pets.||
4133|245|R|   Do not flush medications down the toilet or pour them into a||
4133|246|R|drain unless instructed to do so. Properly discard this product||
4133|247|R|when it is expired or no longer needed. Consult your pharmacist||
4133|248|R|or local waste disposal company.||
4133|249|B|||
4133|250|M|MEDICAL ALERT:  Your condition can cause complications in a||
4133|251|M|medical emergency. For information about enrolling in MedicAlert,||
4133|252|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4133|253|B|||
4133|254|A|Information last revised August 2025.||
4133|255|A|Copyright(c) 2025 First Databank, Inc.||
4133|256|B|||
4136|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4136|002|Z|does NOT have all possible information about this product. This||
4136|003|Z|information does not assure that this product is safe, effective,||
4136|004|Z|or appropriate for you. This information is not individual||
4136|005|Z|medical advice and does not substitute for the advice of your||
4136|006|Z|health care professional. Always ask your health care||
4136|007|Z|professional for complete information about this product and your||
4136|008|Z|specific health needs.||
4136|009|B|||
4136|010|T|MITOXANTRONE - INJECTION||
4136|011|F|(my-toe-ZAN-trone)||
4136|012|B|||
4136|013|C|COMMON BRAND NAME(S): Novantrone||
4136|014|B|||
4136|015|W|WARNING:  Mitoxantrone must be given only by injection into a||
4136|016|W|vein. Do not give by injection into a muscle, under the skin, or||
4136|017|W|into the spinal cord. If this medication accidentally leaks into||
4136|018|W|the skin/muscle around the injection site, it may cause severe||
4136|019|W|damage. Tell your doctor right away if you notice redness, pain,||
4136|020|W|or swelling at or near the injection site.||
4136|021|W|   This medication may rarely cause serious (rarely fatal) heart||
4136|022|W|problems (including heart failure). This effect may occur during||
4136|023|W|treatment or months to years after treatment is completed. The||
4136|024|W|risk of heart problems is affected by your dose, medical history||
4136|025|W|(including previous heart disease, radiation treatment to the||
4136|026|W|chest area, or if you have MS-multiple sclerosis), and previous||
4136|027|W|use of this and other drugs (including doxorubicin or||
4136|028|W|daunorubicin). Tell your doctor right away if you notice symptoms||
4136|029|W|such as irregular heartbeat, shortness of breath, swelling||
4136|030|W|ankles/feet, unusual tiredness, or unusual/sudden weight gain.||
4136|031|W|   Very rarely, people who are treated with this type of||
4136|032|W|medication have developed new cancers (such as secondary||
4136|033|W|leukemia). The risk may be increased when this medication is||
4136|034|W|given with certain anti-cancer drugs or radiation treatment.||
4136|035|W|Consult your doctor for more details.||
4136|036|W|   Lab and/or medical tests (such as complete blood count,||
4136|037|W|heart/liver function tests, ECG) should be done before you start||
4136|038|W|treatment with this medication and while you are using it. Keep||
4136|039|W|all medical and lab appointments. Consult your doctor for more||
4136|040|W|details.||
4136|041|B|||
4136|042|U|USES:  Mitoxantrone is used to treat leukemia and other cancers.||
4136|043|U|It is also used to treat multiple sclerosis. It belongs to a||
4136|044|U|class of drugs known as anthracenediones and works by slowing or||
4136|045|U|stopping the growth of certain cells (including cancer cells and||
4136|046|U|cells that affect the body's natural defenses).||
4136|047|B|||
4136|048|H|HOW TO USE:  Read the Medication Guide provided by your||
4136|049|H|pharmacist before you start receiving mitoxantrone and each time||
4136|050|H|you get a refill. If you have any questions, ask your doctor or||
4136|051|H|pharmacist.||
4136|052|H|   This medication is given by injection into a vein by a health||
4136|053|H|care professional as directed by your doctor. The dosage is based||
4136|054|H|on your medical condition, body size, and response to treatment.||
4136|055|H|   If this medication touches your skin, immediately wash the||
4136|056|H|area well with soap and water. If this medication gets in your||
4136|057|H|eye, open the eyelid and flush with water for 15 minutes, then||
4136|058|H|get medical help right away.||
4136|059|B|||
4136|060|S|SIDE EFFECTS:  See also Warning section.||
4136|061|S|   Nausea, vomiting, diarrhea, headache, or unusual tiredness may||
4136|062|S|occur. In some cases, your doctor may prescribe medication to||
4136|063|S|prevent or relieve nausea and vomiting. Eating several small||
4136|064|S|meals, not eating before treatment, or limiting activity may help||
4136|065|S|lessen some of these effects. If these effects last or get worse,||
4136|066|S|tell your doctor or pharmacist promptly.||
4136|067|S|   Pain or sores in the mouth and throat may occur. Brush your||
4136|068|S|teeth gently/carefully, avoid using mouthwash that contains||
4136|069|S|alcohol, and rinse your mouth often with cool water mixed with||
4136|070|S|baking soda or salt. It may also be best to eat soft, moist||
4136|071|S|foods.||
4136|072|S|   Temporary hair thinning/loss may occur. Normal hair growth||
4136|073|S|should return after treatment has ended.||
4136|074|S|   This medication may cause your urine to turn blue-green. The||
4136|075|S|white part of your eyes may also turn a bluish color. These||
4136|076|S|effects are temporary, normal, and harmless.||
4136|077|S|   People using this medication may have serious side effects.||
4136|078|S|However, you have been prescribed this drug because your doctor||
4136|079|S|has judged that the benefit to you is greater than the risk of||
4136|080|S|side effects. Careful monitoring by your doctor may decrease your||
4136|081|S|risk.||
4136|082|S|   Severe nausea, vomiting, or diarrhea may rarely cause||
4136|083|S|dehydration. Tell your doctor right away if you notice any||
4136|084|S|symptoms of dehydration such as unusual decreased urination,||
4136|085|S|unusual dry mouth/increased thirst, lack of tears,||
4136|086|S|dizziness/lightheadedness, or pale/wrinkled skin.||
4136|087|S|   Tell your doctor right away if you have any serious side||
4136|088|S|effects, including: menstrual changes (such as stopped periods),||
4136|089|S|unusual bleeding/bruising (such as small red spots on the skin,||
4136|090|S|black/bloody stools, bloody urine, vomit that looks like coffee||
4136|091|S|grounds), numbness/tingling feelings, seizure.||
4136|092|S|   This medication can lower the body's ability to fight an||
4136|093|S|infection. Tell your doctor right away if you develop any signs||
4136|094|S|of an infection (such as sore throat that doesn't go away, fever,||
4136|095|S|chills).||
4136|096|S|   A very serious allergic reaction to this drug is rare.||
4136|097|S|However, get medical help right away if you notice any symptoms||
4136|098|S|of a serious allergic reaction, including: rash, itching/swelling||
4136|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4136|100|S|breathing.||
4136|101|S|   This is not a complete list of possible side effects. If you||
4136|102|S|notice other effects not listed above, contact your doctor or||
4136|103|S|pharmacist.||
4136|104|S|   In the US -||
4136|105|S|   Call your doctor for medical advice about side effects. You||
4136|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4136|107|S|www.fda.gov/medwatch.||
4136|108|S|   In Canada - Call your doctor for medical advice about side||
4136|109|S|effects. You may report side effects to Health Canada at||
4136|110|S|1-866-234-2345.||
4136|111|B|||
4136|112|P|PRECAUTIONS:  Before using mitoxantrone, tell your doctor or||
4136|113|P|pharmacist if you are allergic to it; or if you have any other||
4136|114|P|allergies. This product may contain inactive ingredients, which||
4136|115|P|can cause allergic reactions or other problems. Talk to your||
4136|116|P|pharmacist for more details.||
4136|117|P|   Before using this medication, tell your doctor or pharmacist||
4136|118|P|your medical history, especially of: blood/bleeding disorders||
4136|119|P|(such as anemia, low blood cell counts), heart disease (such as||
4136|120|P|heart failure, irregular heartbeat), liver disease, radiation||
4136|121|P|treatment, recent/current infection.||
4136|122|P|   Tell your health care professional that you are using||
4136|123|P|mitoxantrone before having any immunizations/vaccinations. Avoid||
4136|124|P|contact with people who have recently received live vaccines||
4136|125|P|(such as flu vaccine inhaled through the nose).||
4136|126|P|   Mitoxantrone can make you more likely to get infections or may||
4136|127|P|make current infections worse. Stay away from anyone who has an||
4136|128|P|infection that may easily spread (such as chickenpox, COVID-19,||
4136|129|P|measles, flu). Talk to your doctor if you have been exposed to an||
4136|130|P|infection or for more details.||
4136|131|P|   To lower your risk of getting cut, bruised, or injured, use||
4136|132|P|caution with sharp objects like razors and nail cutters, and||
4136|133|P|avoid activities such as contact sports.||
4136|134|P|   Before having surgery, tell your doctor or dentist about all||
4136|135|P|the products you use (including prescription drugs,||
4136|136|P|nonprescription drugs, and herbal products).||
4136|137|P|   Tell your doctor if you are pregnant or plan to become||
4136|138|P|pregnant. You should not become pregnant while using||
4136|139|P|mitoxantrone. Mitoxantrone may harm an unborn baby. Your doctor||
4136|140|P|should order a pregnancy test before you start this medication.||
4136|141|P|Men and women using this medication should ask about reliable||
4136|142|P|forms of birth control during treatment. If you or your partner||
4136|143|P|becomes pregnant, talk to your doctor right away about the risks||
4136|144|P|and benefits of this medication.||
4136|145|P|   This medication passes into breast milk and could have||
4136|146|P|undesirable effects on a nursing infant. Breastfeeding is not||
4136|147|P|recommended while using this medication. Consult your doctor||
4136|148|P|before breastfeeding.||
4136|149|B|||
4136|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4136|151|I|medications work or increase your risk for serious side effects.||
4136|152|I|This document does not contain all possible drug interactions.||
4136|153|I|Keep a list of all the products you use (including||
4136|154|I|prescription/nonprescription drugs and herbal products) and share||
4136|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
4136|156|I|the dosage of any medicines without your doctor's approval.||
4136|157|I|   Some products that may interact with this drug include: other||
4136|158|I|anti-cancer drugs (especially anthracyclines such as||
4136|159|I|doxorubicin).||
4136|160|B|||
4136|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4136|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4136|163|O|poison control center right away. US residents can call||
4136|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4136|165|B|||
4136|166|N|NOTES:  Keep all medical and lab appointments.||
4136|167|B|||
4136|168|D|MISSED DOSE:  It is important to get each dose of this medication||
4136|169|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
4136|170|D|right away for a new dosing schedule.||
4136|171|B|||
4136|172|R|STORAGE:  Not applicable. This medication is given in a clinic||
4136|173|R|and will not be stored at home.||
4136|174|B|||
4136|175|M|MEDICAL ALERT:  Your condition can cause complications in a||
4136|176|M|medical emergency. For information about enrolling in MedicAlert,||
4136|177|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4136|178|B|||
4136|179|A|Information last revised May 2025.||
4136|180|A|Copyright(c) 2025 First Databank, Inc.||
4136|181|B|||
4143|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4143|002|Z|does NOT have all possible information about this product. This||
4143|003|Z|information does not assure that this product is safe, effective,||
4143|004|Z|or appropriate for you. This information is not individual||
4143|005|Z|medical advice and does not substitute for the advice of your||
4143|006|Z|health care professional. Always ask your health care||
4143|007|Z|professional for complete information about this product and your||
4143|008|Z|specific health needs.||
4143|009|B|||
4143|010|T|ESOMEPRAZOLE DELAYED-RELEASE CAPSULE - ORAL||
4143|011|F|(ES-oh-MEP-ra-zole)||
4143|012|B|||
4143|013|C|COMMON BRAND NAME(S): Nexium||
4143|014|B|||
4143|015|U|USES:  Esomeprazole is used to treat certain stomach and||
4143|016|U|esophagus problems (such as acid reflux, ulcers). It works by||
4143|017|U|decreasing the amount of acid your stomach makes. It relieves||
4143|018|U|symptoms such as heartburn, difficulty swallowing, and cough.||
4143|019|U|This medication helps heal acid damage to the stomach and||
4143|020|U|esophagus, helps prevent ulcers, and may help prevent cancer of||
4143|021|U|the esophagus. Esomeprazole belongs to a class of drugs known as||
4143|022|U|proton pump inhibitors (PPIs).||
4143|023|U|   If you are self-treating with this medication,||
4143|024|U|over-the-counter esomeprazole products are used to treat frequent||
4143|025|U|heartburn (occurring 2 or more days a week). Since it may take 1||
4143|026|U|to 4 days to have full effect, these products do not relieve||
4143|027|U|heartburn right away.||
4143|028|U|   For over-the-counter products, carefully read the package||
4143|029|U|instructions to make sure the product is right for you. Check the||
4143|030|U|ingredients on the label even if you have used the product||
4143|031|U|before. The manufacturer may have changed the ingredients. Also,||
4143|032|U|products with similar brand names may contain different||
4143|033|U|ingredients meant for different purposes. Taking the wrong||
4143|034|U|product could harm you.||
4143|035|B|||
4143|036|H|HOW TO USE:  Read the Medication Guide and the Patient||
4143|037|H|Information Leaflet if available from your pharmacist before you||
4143|038|H|start taking esomeprazole and each time you get a refill. If you||
4143|039|H|have any questions, ask your doctor or pharmacist.||
4143|040|H|   Take this medication by mouth as directed by your doctor,||
4143|041|H|usually once daily, at least 1 hour before a meal. If you are||
4143|042|H|self-treating, follow all directions on the product package. The||
4143|043|H|dosage and length of treatment are based on your medical||
4143|044|H|condition and response to treatment. Do not increase your dose or||
4143|045|H|take this drug more often than directed. If you have any||
4143|046|H|questions, ask your doctor or pharmacist.||
4143|047|H|   Do not crush or chew this medication. Swallow the capsules||
4143|048|H|whole. If you have difficulty swallowing this medication whole,||
4143|049|H|you may open the capsule and sprinkle the contents into a||
4143|050|H|tablespoon of unheated applesauce. Swallow the applesauce mixture||
4143|051|H|right away without chewing it. Do not prepare the mixture ahead||
4143|052|H|of time for later use. Doing so may destroy the drug.||
4143|053|H|   If needed, antacids may be taken along with this medication.||
4143|054|H|If you are also taking sucralfate, take esomeprazole at least 30||
4143|055|H|minutes before sucralfate.||
4143|056|H|   Use this medication regularly to get the most benefit from it.||
4143|057|H|To help you remember, take it at the same time each day. Continue||
4143|058|H|to take this medication for the prescribed length of treatment||
4143|059|H|even if you are feeling better. If you are self-treating with the||
4143|060|H|over-the-counter product, do not take it for more than 14 days||
4143|061|H|unless directed by your doctor.||
4143|062|H|   Tell your doctor if your condition lasts or gets worse. If you||
4143|063|H|are self-treating, tell your doctor if your heartburn lasts after||
4143|064|H|14 days or if you need to use this medication more than once||
4143|065|H|every 4 months. The risk of side effects goes up over time. Ask||
4143|066|H|your doctor how long you should take this medication. If you||
4143|067|H|think you may have a serious medical problem, get medical help||
4143|068|H|right away.||
4143|069|B|||
4143|070|S|SIDE EFFECTS:  See also Precautions section.||
4143|071|S|   Headache or abdominal pain may occur. If any of these effects||
4143|072|S|last or get worse, tell your doctor or pharmacist promptly.||
4143|073|S|   Remember that this medication has been prescribed because your||
4143|074|S|doctor has judged that the benefit to you is greater than the||
4143|075|S|risk of side effects. Many people using this medication do not||
4143|076|S|have serious side effects.||
4143|077|S|   Tell your doctor right away if you have any serious side||
4143|078|S|effects, including: symptoms of a low magnesium blood level (such||
4143|079|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
4143|080|S|(such as rash on nose and cheeks, new or worsening joint pain),||
4143|081|S|signs of kidney problems (such as change in the amount of urine,||
4143|082|S|pink/bloody urine).||
4143|083|S|   This medication may rarely cause a severe intestinal condition||
4143|084|S|due to a bacteria called C. difficile. This condition may occur||
4143|085|S|during treatment or weeks to months after treatment has stopped.||
4143|086|S|Tell your doctor right away if you develop: diarrhea that doesn't||
4143|087|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
4143|088|S|stool.||
4143|089|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4143|090|S|products because they may make symptoms worse.||
4143|091|S|   Rarely, proton pump inhibitors (such as esomeprazole) have||
4143|092|S|caused vitamin B-12 deficiency. The risk is increased if they are||
4143|093|S|taken every day for a long time (3 years or longer). Tell your||
4143|094|S|doctor right away if you develop symptoms of vitamin B-12||
4143|095|S|deficiency (such as unusual weakness, sore tongue, or||
4143|096|S|numbness/tingling of the hands/feet).||
4143|097|S|   A very serious allergic reaction to this drug is rare.||
4143|098|S|However, get medical help right away if you notice any symptoms||
4143|099|S|of a serious allergic reaction, including: fever, swollen lymph||
4143|100|S|nodes, rash, itching/swelling (especially of the||
4143|101|S|face/tongue/throat), severe dizziness, trouble breathing.||
4143|102|S|   This is not a complete list of possible side effects. If you||
4143|103|S|notice other effects not listed above, contact your doctor or||
4143|104|S|pharmacist.||
4143|105|S|   In the US -||
4143|106|S|   Call your doctor for medical advice about side effects. You||
4143|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4143|108|S|www.fda.gov/medwatch.||
4143|109|S|   In Canada - Call your doctor for medical advice about side||
4143|110|S|effects. You may report side effects to Health Canada at||
4143|111|S|1-866-234-2345.||
4143|112|B|||
4143|113|P|PRECAUTIONS:  Before taking esomeprazole, tell your doctor or||
4143|114|P|pharmacist if you are allergic to it; or to similar drugs (such||
4143|115|P|as lansoprazole, omeprazole); or if you have any other allergies.||
4143|116|P|This product may contain inactive ingredients, which can cause||
4143|117|P|allergic reactions or other problems. Talk to your pharmacist for||
4143|118|P|more details.||
4143|119|P|   Before using this medication, tell your doctor or pharmacist||
4143|120|P|your medical history, especially of: liver disease, lupus.||
4143|121|P|   Some symptoms may actually be signs of a more serious||
4143|122|P|condition. Get medical help right away if you have: heartburn||
4143|123|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
4143|124|P|pain (especially with shortness of breath, unusual sweating),||
4143|125|P|unexplained weight loss.||
4143|126|P|   In addition, before you self-treat with this medication, get||
4143|127|P|medical help right away if you have any of these signs of a||
4143|128|P|serious condition: trouble/pain swallowing food, bloody vomit,||
4143|129|P|vomit that looks like coffee grounds, bloody/black stools,||
4143|130|P|heartburn for over 3 months, frequent chest pain, frequent||
4143|131|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
4143|132|P|pain.||
4143|133|P|   Before having surgery, tell your doctor or dentist about all||
4143|134|P|the products you use (including prescription drugs,||
4143|135|P|nonprescription drugs, and herbal products).||
4143|136|P|   Proton pump inhibitors (such as esomeprazole) may increase||
4143|137|P|your risk for bone fractures, especially with longer use, higher||
4143|138|P|doses, and in older adults. Talk with your doctor or pharmacist||
4143|139|P|about ways to prevent bone loss/fracture, such as by taking||
4143|140|P|calcium (such as calcium citrate) and vitamin D supplements.||
4143|141|P|   Older adults may be more sensitive to the side effects of this||
4143|142|P|drug, especially bone loss and fractures (see above), and C.||
4143|143|P|difficile infection (see Side Effects section).||
4143|144|P|   Children may be more sensitive to the side effects of this||
4143|145|P|drug, especially fever, cough, and infections of the||
4143|146|P|nose/throat/airways.||
4143|147|P|   During pregnancy, this medication should be used only when||
4143|148|P|clearly needed. Discuss the risks and benefits with your doctor.||
4143|149|P|   It is unknown if this medication passes into breast milk.||
4143|150|P|However, similar drugs pass into breast milk. The effects on a||
4143|151|P|nursing infant are unknown. Consult your doctor before||
4143|152|P|breastfeeding.||
4143|153|B|||
4143|154|I|DRUG INTERACTIONS:  See also How to Use section.||
4143|155|I|   Drug interactions may change how your medications work or||
4143|156|I|increase your risk for serious side effects. This document does||
4143|157|I|not contain all possible drug interactions. Keep a list of all||
4143|158|I|the products you use (including prescription/nonprescription||
4143|159|I|drugs and herbal products) and share it with your doctor and||
4143|160|I|pharmacist. Do not start, stop, or change the dosage of any||
4143|161|I|medicines without your doctor's approval.||
4143|162|I|   Some products that may interact with this drug include:||
4143|163|I|clopidogrel, methotrexate (especially high-dose treatment),||
4143|164|I|rifampin, St John's wort.||
4143|165|I|   Some products need stomach acid so that the body can absorb||
4143|166|I|them properly. Esomeprazole decreases stomach acid, so it may||
4143|167|I|change how well these products work. Some affected products||
4143|168|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
4143|169|I|pazopanib, rilpivirine, sparsentan, certain azole antifungals||
4143|170|I|(itraconazole, ketoconazole, posaconazole), among others.||
4143|171|I|   Esomeprazole is very similar to omeprazole. Do not use any||
4143|172|I|medications containing omeprazole while using esomeprazole.||
4143|173|I|   This medication may interfere with certain lab tests, possibly||
4143|174|I|causing false test results. Make sure lab personnel and all your||
4143|175|I|doctors know you use this drug.||
4143|176|B|||
4143|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4143|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4143|179|O|poison control center right away. US residents can call||
4143|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4143|181|O|Symptoms of overdose may include: confusion, extreme sweating,||
4143|182|O|blurred vision, or unusually fast heartbeat.||
4143|183|B|||
4143|184|N|NOTES:  If your doctor has prescribed this medication for you, do||
4143|185|N|not share it with others.||
4143|186|N|   If your doctor instructs you to use this medication regularly||
4143|187|N|for a long time, lab and/or medical tests (such as a magnesium||
4143|188|N|blood test, vitamin B-12 levels) may be done while you are taking||
4143|189|N|this medication. Keep all medical and lab appointments. Consult||
4143|190|N|your doctor for more details.||
4143|191|B|||
4143|192|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4143|193|D|remember. If it is near the time of the next dose, skip the||
4143|194|D|missed dose. Take your next dose at the regular time. Do not||
4143|195|D|double the dose to catch up.||
4143|196|B|||
4143|197|R|STORAGE:  Store at room temperature away from moisture. Do not||
4143|198|R|store in the bathroom. Keep all medications away from children||
4143|199|R|and pets.||
4143|200|R|   Do not flush medications down the toilet or pour them into a||
4143|201|R|drain unless instructed to do so. Properly discard this product||
4143|202|R|when it is expired or no longer needed. Consult your pharmacist||
4143|203|R|or local waste disposal company.||
4143|204|B|||
4143|205|A|Information last revised April 2025.||
4143|206|A|Copyright(c) 2025 First Databank, Inc.||
4143|207|B|||
4146|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4146|002|Z|does NOT have all possible information about this product. This||
4146|003|Z|information does not assure that this product is safe, effective,||
4146|004|Z|or appropriate for you. This information is not individual||
4146|005|Z|medical advice and does not substitute for the advice of your||
4146|006|Z|health care professional. Always ask your health care||
4146|007|Z|professional for complete information about this product and your||
4146|008|Z|specific health needs.||
4146|009|B|||
4146|010|T|BALSALAZIDE - ORAL||
4146|011|F|(bal-SAL-a-zide)||
4146|012|B|||
4146|013|C|COMMON BRAND NAME(S): Colazal||
4146|014|B|||
4146|015|U|USES:  Balsalazide is used to treat a certain bowel disease||
4146|016|U|(ulcerative colitis). It helps to reduce symptoms of ulcerative||
4146|017|U|colitis such as diarrhea, rectal bleeding, and stomach pain.||
4146|018|U|Balsalazide belongs to a class of drugs known as||
4146|019|U|aminosalicylates. It works by decreasing swelling in the colon.||
4146|020|B|||
4146|021|H|HOW TO USE:  Take this medication by mouth with or without food||
4146|022|H|as directed by your doctor, usually 3 times daily. The dosage is||
4146|023|H|based on your age, medical condition, and response to treatment.||
4146|024|H|   Drink plenty of fluids during treatment with this medication||
4146|025|H|unless otherwise directed by your doctor. This will help prevent||
4146|026|H|kidney stones.||
4146|027|H|   If you have trouble swallowing the capsules, you may open them||
4146|028|H|and sprinkle the contents onto a spoonful of applesauce. Swallow||
4146|029|H|the food/medication mixture right away. Do not prepare a supply||
4146|030|H|in advance.||
4146|031|H|   Use this medication regularly to get the most benefit from it.||
4146|032|H|To help you remember, take it at the same times each day.||
4146|033|H|   Tell your doctor if your condition does not get better or if||
4146|034|H|it gets worse.||
4146|035|B|||
4146|036|S|SIDE EFFECTS:  Headache, nausea, vomiting, joint pain, diarrhea,||
4146|037|S|abdominal pain, fever, sore throat, trouble sleeping, or loss of||
4146|038|S|appetite may occur. If any of these effects last or get worse,||
4146|039|S|tell your doctor or pharmacist promptly.||
4146|040|S|   Remember that this medication has been prescribed because your||
4146|041|S|doctor has judged that the benefit to you is greater than the||
4146|042|S|risk of side effects. Many people using this medication do not||
4146|043|S|have serious side effects.||
4146|044|S|   Rarely, balsalazide can worsen ulcerative colitis. Tell your||
4146|045|S|doctor right away if your symptoms worsen after starting this||
4146|046|S|medication (for example, if you have increased abdominal pain,||
4146|047|S|rectal bleeding).||
4146|048|S|   Tell your doctor right away if you have any serious side||
4146|049|S|effects, including: nausea/vomiting that doesn't stop, signs of||
4146|050|S|kidney problems (such as change in the amount of urine),||
4146|051|S|yellowing eyes/skin, dark urine, unusual/extreme tiredness,||
4146|052|S|severe stomach/abdominal pain, burning/painful urination,||
4146|053|S|fast/pounding heartbeat.||
4146|054|S|   A very serious allergic reaction to this drug is rare.||
4146|055|S|However, get medical help right away if you notice any symptoms||
4146|056|S|of a serious allergic reaction, including: fever, swollen lymph||
4146|057|S|nodes, rash, itching/swelling (especially of the||
4146|058|S|face/tongue/throat), severe dizziness, trouble breathing.||
4146|059|S|   This is not a complete list of possible side effects. If you||
4146|060|S|notice other effects not listed above, contact your doctor or||
4146|061|S|pharmacist.||
4146|062|S|   In the US -||
4146|063|S|   Call your doctor for medical advice about side effects. You||
4146|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4146|065|S|www.fda.gov/medwatch.||
4146|066|S|   In Canada - Call your doctor for medical advice about side||
4146|067|S|effects. You may report side effects to Health Canada at||
4146|068|S|1-866-234-2345.||
4146|069|B|||
4146|070|P|PRECAUTIONS:  Before taking balsalazide, tell your doctor or||
4146|071|P|pharmacist if you are allergic to it; or to other||
4146|072|P|aminosalicylates (such as mesalamine, olsalazine); or to||
4146|073|P|salicylates (such as aspirin, salsalate); or to sulfasalazine; or||
4146|074|P|if you have any other allergies. This product may contain||
4146|075|P|inactive ingredients, which can cause allergic reactions or other||
4146|076|P|problems. Talk to your pharmacist for more details.||
4146|077|P|   Before using this medication, tell your doctor or pharmacist||
4146|078|P|your medical history, especially of: a certain stomach/intestinal||
4146|079|P|condition (pyloric stenosis), liver disease, kidney disease.||
4146|080|P|   This medication may make you more sensitive to the sun,||
4146|081|P|especially if you have skin problems (such as atopic dermatitis,||
4146|082|P|eczema). Limit your time in the sun. Avoid tanning booths and||
4146|083|P|sunlamps. Use sunscreen and wear protective clothing when||
4146|084|P|outdoors. Tell your doctor right away if you get sunburned or||
4146|085|P|have skin blisters/redness.||
4146|086|P|   Before having surgery, tell your doctor or dentist about all||
4146|087|P|the products you use (including prescription drugs,||
4146|088|P|nonprescription drugs, and herbal products).||
4146|089|P|   This medication contains sodium. Consult your doctor or||
4146|090|P|pharmacist if you are on a salt-restricted diet or if you have a||
4146|091|P|condition that could be worsened by an increase in salt intake||
4146|092|P|(such as heart failure).||
4146|093|P|   This medication is similar to aspirin. Children and teenagers||
4146|094|P|younger than 18 years should not take aspirin if they have||
4146|095|P|chickenpox, flu, or any undiagnosed illness or if they have||
4146|096|P|recently received a vaccine. In these cases, taking aspirin||
4146|097|P|increases the risk of Reye's syndrome, a rare but serious||
4146|098|P|illness.||
4146|099|P|   During pregnancy, this medication should be used only when||
4146|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
4146|101|P|   This medication may pass into breast milk. Consult your doctor||
4146|102|P|before breastfeeding.||
4146|103|B|||
4146|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4146|105|I|medications work or increase your risk for serious side effects.||
4146|106|I|This document does not contain all possible drug interactions.||
4146|107|I|Keep a list of all the products you use (including||
4146|108|I|prescription/nonprescription drugs and herbal products) and share||
4146|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
4146|110|I|the dosage of any medicines without your doctor's approval.||
4146|111|I|   A product that may interact with this drug is:||
4146|112|I|dichlorphenamide.||
4146|113|I|   Balsalazide is very similar to mesalamine. Do not use||
4146|114|I|mesalamine medications taken by mouth while using balsalazide.||
4146|115|I|   This medication may interfere with certain lab tests||
4146|116|I|(including urine normetanephrine levels), possibly causing false||
4146|117|I|test results. Make sure lab personnel and all your doctors know||
4146|118|I|you use this drug.||
4146|119|B|||
4146|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4146|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4146|122|O|poison control center right away. US residents can call||
4146|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4146|124|B|||
4146|125|N|NOTES:  Do not share this medication with others.||
4146|126|N|   Lab and/or medical tests (such as kidney/liver function) may||
4146|127|N|be done while you are taking this medication. Keep all medical||
4146|128|N|and lab appointments. Consult your doctor for more details.||
4146|129|B|||
4146|130|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4146|131|D|remember. If it is near the time of the next dose, skip the||
4146|132|D|missed dose. Take your next dose at the regular time. Do not||
4146|133|D|double the dose to catch up.||
4146|134|B|||
4146|135|R|STORAGE:  Store at room temperature away from light and moisture.||
4146|136|R|Do not store in the bathroom. Keep all medications away from||
4146|137|R|children and pets.||
4146|138|R|   Do not flush medications down the toilet or pour them into a||
4146|139|R|drain unless instructed to do so. Properly discard this product||
4146|140|R|when it is expired or no longer needed. Consult your pharmacist||
4146|141|R|or local waste disposal company.||
4146|142|B|||
4146|143|A|Information last revised May 2024.||
4146|144|A|Copyright(c) 2025 First Databank, Inc.||
4146|145|B|||
4154|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4154|002|Z|does NOT have all possible information about this product. This||
4154|003|Z|information does not assure that this product is safe, effective,||
4154|004|Z|or appropriate for you. This information is not individual||
4154|005|Z|medical advice and does not substitute for the advice of your||
4154|006|Z|health care professional. Always ask your health care||
4154|007|Z|professional for complete information about this product and your||
4154|008|Z|specific health needs.||
4154|009|B|||
4154|010|T|LINEZOLID - INJECTION||
4154|011|F|(lin-AYZ-oh-lid)||
4154|012|B|||
4154|013|C|COMMON BRAND NAME(S): Zyvox||
4154|014|B|||
4154|015|U|USES:  Linezolid is an antibiotic used to treat certain serious||
4154|016|U|bacterial infections. It works by stopping the growth of||
4154|017|U|bacteria.||
4154|018|U|   Linezolid also belongs to a class of drugs known as MAO||
4154|019|U|inhibitors. It can increase the levels of certain natural||
4154|020|U|substances in the body (such as dopamine, norepinephrine,||
4154|021|U|serotonin) which can increase the chance of certain side effects||
4154|022|U|and food and drug interactions. See How to Use, Side Effects, and||
4154|023|U|Drug Interactions sections for more details.||
4154|024|B|||
4154|025|H|HOW TO USE:  This medication is given by injection into a vein as||
4154|026|H|directed by your doctor, usually every 12 hours. It should be||
4154|027|H|injected slowly over 30 minutes to 2 hours. The dosage is based||
4154|028|H|on your medical condition and response to treatment. Children's||
4154|029|H|dosage is also based on age and weight, and they may be directed||
4154|030|H|to use this medication every 8 hours.||
4154|031|H|   If you are using this medication at home, learn all||
4154|032|H|preparation and usage instructions from your health care||
4154|033|H|professional. Before using, check this product for particles or||
4154|034|H|discoloration. If either is present, do not use the liquid. Learn||
4154|035|H|how to store and discard medical supplies safely.||
4154|036|H|   To prevent a very serious high blood pressure reaction, it is||
4154|037|H|very important that you follow a special diet recommended by your||
4154|038|H|doctor or dietician to limit your intake of tyramine while you||
4154|039|H|are using this medicine. Avoid foods and beverages that are high||
4154|040|H|in tyramine, including aged cheeses, dried/aged meats and||
4154|041|H|sausages (such as salami, liverwurst), preserved fish (such as||
4154|042|H|pickled herring), products that contain large amounts of yeast||
4154|043|H|(such as bouillon cubes, powdered soup/gravy, homemade or||
4154|044|H|sourdough bread), fermented foods (such as sauerkraut, kim chee),||
4154|045|H|most soybean products (such as soy sauce, tofu), broad/fava||
4154|046|H|beans, red wine, sherry, tap beers, and vermouth. Consult your||
4154|047|H|doctor or dietician for more details and a complete list of other||
4154|048|H|foods that contain tyramine which you should limit or avoid.||
4154|049|H|   For the best effect, use this antibiotic at evenly spaced||
4154|050|H|times. To help you remember, use this medication at the same||
4154|051|H|time(s) every day.||
4154|052|H|   Continue to use this medication until the full prescribed||
4154|053|H|treatment period is finished, even if symptoms disappear after a||
4154|054|H|few days. Stopping the medication too early may result in a||
4154|055|H|return of the infection.||
4154|056|H|   Tell your doctor if your condition lasts or gets worse.||
4154|057|B|||
4154|058|S|SIDE EFFECTS:  Diarrhea, headache, nausea, vomiting, or dizziness||
4154|059|S|may occur. If any of these effects last or get worse, tell your||
4154|060|S|doctor or pharmacist promptly.||
4154|061|S|   Remember that this medication has been prescribed because your||
4154|062|S|doctor has judged that the benefit to you is greater than the||
4154|063|S|risk of side effects. Many people using this medication do not||
4154|064|S|have serious side effects.||
4154|065|S|   Tell your doctor right away if you have any serious side||
4154|066|S|effects, including: deep/fast breathing, unusual drowsiness,||
4154|067|S|nausea/vomiting that doesn't stop, numbness/tingling of the||
4154|068|S|hands/feet, unusual tiredness, easy bruising/bleeding, muscle||
4154|069|S|pain/tenderness/weakness.||
4154|070|S|   Get medical help right away if you have any very serious side||
4154|071|S|effects, including: muscle stiffness, increased sweating, vision||
4154|072|S|changes (such as blurred vision, change in color vision, loss of||
4154|073|S|vision), mental/mood changes (such as agitation, confusion),||
4154|074|S|seizure.||
4154|075|S|   This medication may rarely cause a severe intestinal condition||
4154|076|S|due to a bacteria called C. difficile. This condition may occur||
4154|077|S|during treatment or weeks to months after treatment has stopped.||
4154|078|S|Tell your doctor right away if you develop: diarrhea that doesn't||
4154|079|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
4154|080|S|stool.||
4154|081|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4154|082|S|products because they may make symptoms worse.||
4154|083|S|   Use of this medication for prolonged or repeated periods may||
4154|084|S|result in oral thrush or a new yeast infection. Contact your||
4154|085|S|doctor if you notice white patches in your mouth, a change in||
4154|086|S|vaginal discharge, or other new symptoms.||
4154|087|S|   This medication may increase serotonin and rarely cause a very||
4154|088|S|serious condition called serotonin syndrome/toxicity. The risk||
4154|089|S|increases if you are also using other drugs that increase||
4154|090|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
4154|091|S|use. Get medical help right away if you develop some of the||
4154|092|S|following symptoms: fast heartbeat, hallucinations, loss of||
4154|093|S|coordination, severe dizziness, severe nausea/vomiting/diarrhea,||
4154|094|S|twitching muscles, unexplained fever, unusual||
4154|095|S|agitation/restlessness.||
4154|096|S|   This drug may rarely cause an attack of extremely high blood||
4154|097|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
4154|098|S|food interactions can increase this risk (see How to Use and Drug||
4154|099|S|Interactions sections). Get medical help right away if any of||
4154|100|S|these serious side effects occur: severe headache,||
4154|101|S|fast/slow/irregular/pounding heartbeat, chest pain, neck||
4154|102|S|stiffness/soreness, severe nausea/vomiting, sweating/clammy skin||
4154|103|S|(sometimes with fever), widened pupils, vision changes (such as||
4154|104|S|double/blurred vision), sudden sensitivity to light||
4154|105|S|(photophobia).||
4154|106|S|   A very serious allergic reaction to this drug is rare.||
4154|107|S|However, get medical help right away if you notice any symptoms||
4154|108|S|of a serious allergic reaction, including: rash, itching/swelling||
4154|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4154|110|S|breathing.||
4154|111|S|   This is not a complete list of possible side effects. If you||
4154|112|S|notice other effects not listed above, contact your doctor or||
4154|113|S|pharmacist.||
4154|114|S|   In the US -||
4154|115|S|   Call your doctor for medical advice about side effects. You||
4154|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4154|117|S|www.fda.gov/medwatch.||
4154|118|S|   In Canada - Call your doctor for medical advice about side||
4154|119|S|effects. You may report side effects to Health Canada at||
4154|120|S|1-866-234-2345.||
4154|121|B|||
4154|122|P|PRECAUTIONS:  Before using linezolid, tell your doctor or||
4154|123|P|pharmacist if you are allergic to it; or if you have any other||
4154|124|P|allergies. This product may contain inactive ingredients, which||
4154|125|P|can cause allergic reactions or other problems. Talk to your||
4154|126|P|pharmacist for more details.||
4154|127|P|   Before using this medication, tell your doctor or pharmacist||
4154|128|P|your medical history, especially of: high blood pressure,||
4154|129|P|blood/bone marrow problems (such as low red/white blood cells and||
4154|130|P|platelets), kidney problems, liver problems, certain tumor||
4154|131|P|conditions (such as pheochromocytoma, carcinoid syndrome),||
4154|132|P|overactive thyroid, seizures.||
4154|133|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4154|134|P|can make you more dizzy. Do not drive, use machinery, or do||
4154|135|P|anything that needs alertness until you can do it safely. Limit||
4154|136|P|alcoholic beverages. Talk to your doctor if you are using||
4154|137|P|marijuana (cannabis).||
4154|138|P|   If you have diabetes, linezolid may lower your blood sugar.||
4154|139|P|Check your blood sugar regularly as directed and share the||
4154|140|P|results with your doctor. Tell your doctor right away if you have||
4154|141|P|symptoms of low blood sugar such as sudden sweating, shaking,||
4154|142|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
4154|143|P|hands/feet. Your doctor may need to adjust your diabetes||
4154|144|P|medication, exercise program, or diet.||
4154|145|P|   Linezolid may cause live bacterial vaccines (such as typhoid||
4154|146|P|vaccine) to not work well. Tell your health care professional||
4154|147|P|that you are using linezolid before having any||
4154|148|P|immunizations/vaccinations.||
4154|149|P|   Before having surgery, tell your doctor or dentist about all||
4154|150|P|the products you use (including prescription drugs,||
4154|151|P|nonprescription drugs, and herbal products).||
4154|152|P|   During pregnancy, this medication should be used only when||
4154|153|P|clearly needed. Discuss the risks and benefits with your doctor.||
4154|154|P|   This medication passes into breast milk and may have||
4154|155|P|undesirable effects on a nursing infant. Consult your doctor||
4154|156|P|before breastfeeding.||
4154|157|B|||
4154|158|I|DRUG INTERACTIONS:  See also How to Use section.||
4154|159|I|   Drug interactions may change how your medications work or||
4154|160|I|increase your risk for serious side effects. This document does||
4154|161|I|not contain all possible drug interactions. Keep a list of all||
4154|162|I|the products you use (including prescription/nonprescription||
4154|163|I|drugs and herbal products) and share it with your doctor and||
4154|164|I|pharmacist. Do not start, stop, or change the dosage of any||
4154|165|I|medicines without your doctor's approval.||
4154|166|I|   Some products that may interact with this drug include: diet||
4154|167|I|pills/appetite suppressants (such as diethylpropion), drugs for||
4154|168|I|attention deficit disorder (such as atomoxetine,||
4154|169|I|methylphenidate), apraclonidine, bupropion, buspirone,||
4154|170|I|carbamazepine, cyclobenzaprine, deutetrabenazine, a certain||
4154|171|I|combination product (dextromethorphan/quinidine), maprotiline,||
4154|172|I|methyldopa, metoclopramide, certain opioid pain relievers (such||
4154|173|I|as fentanyl, meperidine, methadone, tapentadol), certain drugs||
4154|174|I|for Parkinson's disease (such as entacapone, levodopa,||
4154|175|I|tolcapone), certain supplements (such as tryptophan, tyramine),||
4154|176|I|tetrabenazine, tricyclic antidepressants (such as amitriptyline,||
4154|177|I|doxepin), valbenazine.||
4154|178|I|   The risk of serotonin syndrome/toxicity increases if you are||
4154|179|I|also using other drugs that increase serotonin. Examples include||
4154|180|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
4154|181|I|antidepressants (including mirtazapine, SSRIs such as||
4154|182|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
4154|183|I|tramadol, certain "triptans" used to treat migraine headaches||
4154|184|I|(such as rizatriptan, sumatriptan, zolmitriptan), among others.||
4154|185|I|The risk of serotonin syndrome/toxicity may be more likely when||
4154|186|I|you start or increase the dose of these drugs.||
4154|187|I|   Some products can interact with linezolid if you use them||
4154|188|I|together, or even if you use them weeks before or after using||
4154|189|I|linezolid. Tell your doctor or pharmacist if you use anything in||
4154|190|I|the list of products that may interact with this drug, or any of||
4154|191|I|the products that increase serotonin, within 2 weeks before or||
4154|192|I|after using linezolid. Also tell them if you have taken||
4154|193|I|fluoxetine within 5 weeks before starting linezolid. Ask your||
4154|194|I|doctor how much time to wait between starting or stopping any of||
4154|195|I|these drugs and starting linezolid.||
4154|196|I|   Taking other MAO inhibitors with this medication may cause a||
4154|197|I|serious (possibly fatal) drug interaction. Do not take any other||
4154|198|I|MAO inhibitors (isocarboxazid, metaxalone, methylene blue,||
4154|199|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
4154|200|I|selegiline, tranylcypromine) during treatment with this||
4154|201|I|medication. Most MAO inhibitors should also not be taken for two||
4154|202|I|weeks before and after treatment with this medication. Ask your||
4154|203|I|doctor when to start or stop using this medication.||
4154|204|I|   Before using linezolid, report the use of drugs that may||
4154|205|I|increase the risk of extremely high blood pressure (hypertensive||
4154|206|I|crisis) when combined with linezolid, including herbal products||
4154|207|I|(such as ephedra/ma huang), allergy and cold products (including||
4154|208|I|decongestants such as phenylephrine/pseudoephedrine), and||
4154|209|I|stimulants (such as amphetamines, ephedrine, epinephrine).||
4154|210|I|Linezolid should not be used with any of these medications. Talk||
4154|211|I|to your doctor or pharmacist for more details.||
4154|212|B|||
4154|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4154|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4154|215|O|poison control center right away. US residents can call||
4154|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4154|217|B|||
4154|218|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
4154|219|N|blood sodium levels) may be done while you are taking this||
4154|220|N|medication. Eye tests should also be done if you take linezolid||
4154|221|N|for 3 months or more, or if you have vision changes. Keep all||
4154|222|N|medical and lab appointments.||
4154|223|B|||
4154|224|D|MISSED DOSE:  It is important to get each dose of this medication||
4154|225|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
4154|226|D|right away for a new dosing schedule. Do not double the dose to||
4154|227|D|catch up.||
4154|228|B|||
4154|229|R|STORAGE:  Store at room temperature. Protect from light and||
4154|230|R|freezing. Keep the infusion bags in the foil outer wrap until||
4154|231|R|ready to use. Keep all medications away from children and pets.||
4154|232|R|   Do not flush medications down the toilet or pour them into a||
4154|233|R|drain unless instructed to do so. Properly discard this product||
4154|234|R|when it is expired or no longer needed. Consult your pharmacist||
4154|235|R|or local waste disposal company.||
4154|236|B|||
4154|237|A|Information last revised November 2024.||
4154|238|A|Copyright(c) 2025 First Databank, Inc.||
4154|239|B|||
4156|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4156|002|Z|does NOT have all possible information about this product. This||
4156|003|Z|information does not assure that this product is safe, effective,||
4156|004|Z|or appropriate for you. This information is not individual||
4156|005|Z|medical advice and does not substitute for the advice of your||
4156|006|Z|health care professional. Always ask your health care||
4156|007|Z|professional for complete information about this product and your||
4156|008|Z|specific health needs.||
4156|009|B|||
4156|010|T|SODIUM FLUORIDE 0.02% RINSE - DENTAL||
4156|011|F|(SO-dee-um FLOOR-ide)||
4156|012|B|||
4156|013|C|COMMON BRAND NAME(S): Phos-Flur||
4156|014|B|||
4156|015|U|USES:  This medication is applied to teeth to prevent cavities.||
4156|016|U|Fluoride is a mineral that works by making the teeth stronger and||
4156|017|U|more resistant to decay caused by acid and bacteria.||
4156|018|U|   Do not use this medication in children younger than 6 years||
4156|019|U|unless directed to do so by your dentist/doctor.||
4156|020|B|||
4156|021|H|HOW TO USE:  Use this rinse once daily (usually at bedtime) or as||
4156|022|H|directed by your dentist/doctor. After brushing your teeth, place||
4156|023|H|2 teaspoonfuls (10 milliliters) of the solution into your mouth,||
4156|024|H|swish vigorously for 1 minute, and spit it out. Do not swallow||
4156|025|H|the medication unless instructed to do so by your dentist/doctor.||
4156|026|H|   Carefully watch children during use and teach proper rinsing||
4156|027|H|habits to avoid swallowing.||
4156|028|H|   To get the most benefit, you should not eat, drink, or rinse||
4156|029|H|your mouth for at least 30 minutes after using the solution.||
4156|030|H|   Dosage is based on age and the amount of fluoride in your||
4156|031|H|drinking water. Do not exceed the recommended dose without||
4156|032|H|checking with your dentist/doctor. Doing so will not do more to||
4156|033|H|prevent cavities but may lead to side effects instead.||
4156|034|H|   Use this medication regularly to get the most benefit from it.||
4156|035|H|To help you remember, use it at the same time each day.||
4156|036|H|   Do not treat this medication like a normal mouthwash: do not||
4156|037|H|use it more often than prescribed, or just to freshen your||
4156|038|H|breath.||
4156|039|B|||
4156|040|S|SIDE EFFECTS:  Tell your dentist/doctor right away if you notice||
4156|041|S|any changes in the color or appearance of your teeth. These||
4156|042|S|effects may be a result of too much fluoride.||
4156|043|S|   If your doctor or dentist has directed you to use this||
4156|044|S|medication, remember that your doctor or dentist has judged that||
4156|045|S|the benefit to you is greater than the risk of side effects. Many||
4156|046|S|people using this medication do not have serious side effects.||
4156|047|S|   A very serious allergic reaction to this drug is rare.||
4156|048|S|However, get medical help right away if you notice any symptoms||
4156|049|S|of a serious allergic reaction, including: rash, itching/swelling||
4156|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4156|051|S|breathing.||
4156|052|S|   This is not a complete list of possible side effects. If you||
4156|053|S|notice other effects not listed above, contact your doctor or||
4156|054|S|pharmacist.||
4156|055|S|   In the US -||
4156|056|S|   Call your doctor for medical advice about side effects. You||
4156|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4156|058|S|www.fda.gov/medwatch.||
4156|059|S|   In Canada - Call your doctor for medical advice about side||
4156|060|S|effects. You may report side effects to Health Canada at||
4156|061|S|1-866-234-2345.||
4156|062|B|||
4156|063|P|PRECAUTIONS:  Before using sodium fluoride, tell your doctor or||
4156|064|P|pharmacist if you are allergic to it; or if you have any other||
4156|065|P|allergies. This product may contain inactive ingredients, which||
4156|066|P|can cause allergic reactions or other problems. Talk to your||
4156|067|P|pharmacist for more details.||
4156|068|P|   Before using this medication, tell your doctor or pharmacist||
4156|069|P|your medical history, especially of: mouth problems (such as||
4156|070|P|sores, mucositis).||
4156|071|P|   Children may be more sensitive to the side effects of this||
4156|072|P|drug, especially if they swallow this medication.||
4156|073|P|   Tell your doctor if you are pregnant before using this||
4156|074|P|medication.||
4156|075|P|   This medication passes into breast milk. Consult your doctor||
4156|076|P|before breastfeeding.||
4156|077|B|||
4156|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4156|079|I|medications work or increase your risk for serious side effects.||
4156|080|I|This document does not contain all possible drug interactions.||
4156|081|I|Keep a list of all the products you use (including||
4156|082|I|prescription/nonprescription drugs and herbal products) and share||
4156|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
4156|084|I|the dosage of any medicines without your doctor's approval.||
4156|085|B|||
4156|086|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4156|087|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4156|088|O|poison control center right away. US residents can call||
4156|089|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4156|090|O|Symptoms of overdose may include: burning in the mouth, sore||
4156|091|O|tongue, nausea, vomiting, diarrhea, increased saliva, stomach||
4156|092|O|pain/cramping, muscle weakness, shaking, seizures.||
4156|093|B|||
4156|094|N|NOTES:  Do not share this medication with others.||
4156|095|N|   Using this medication does not replace good dental habits.||
4156|096|N|Continue to brush and floss your teeth regularly as directed by||
4156|097|N|your dentist, and have regular dental checkups.||
4156|098|B|||
4156|099|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4156|100|D|If it is near the time of the next dose, skip the missed dose.||
4156|101|D|Use your next dose at the regular time. Do not double the dose to||
4156|102|D|catch up.||
4156|103|B|||
4156|104|R|STORAGE:  Store at room temperature. Keep all medications away||
4156|105|R|from children and pets.||
4156|106|R|   Do not flush medications down the toilet or pour them into a||
4156|107|R|drain unless instructed to do so. Properly discard this product||
4156|108|R|when it is expired or no longer needed. Consult your pharmacist||
4156|109|R|or local waste disposal company.||
4156|110|B|||
4156|111|A|Information last revised May 2024.||
4156|112|A|Copyright(c) 2025 First Databank, Inc.||
4156|113|B|||
4157|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4157|002|Z|does NOT have all possible information about this product. This||
4157|003|Z|information does not assure that this product is safe, effective,||
4157|004|Z|or appropriate for you. This information is not individual||
4157|005|Z|medical advice and does not substitute for the advice of your||
4157|006|Z|health care professional. Always ask your health care||
4157|007|Z|professional for complete information about this product and your||
4157|008|Z|specific health needs.||
4157|009|B|||
4157|010|T|IMMUNE GLOBULIN - INTRAMUSCULAR||
4157|011|F|(ih-MYOON GLOB-you-lin)||
4157|012|B|||
4157|013|C|COMMON BRAND NAME(S): Baygam, Gamastan, Gammar||
4157|014|B|||
4157|015|W|WARNING:  This medication may rarely cause serious problems from||
4157|016|W|blood clots (such as heart attack, stroke, blood clots in the||
4157|017|W|lungs or legs). You may be at increased risk for blood clots if||
4157|018|W|you are an older adult, are severely dehydrated, have a catheter||
4157|019|W|in a vein close to your heart for giving medications, or have a||
4157|020|W|history of blood clots, heart/blood vessel disease, heart||
4157|021|W|failure, stroke, or if you are immobile (such as very long plane||
4157|022|W|flights or bedridden). If you use estrogen-containing products,||
4157|023|W|these may also increase your risk. Before using this medication,||
4157|024|W|discuss the risks and benefits and if you have any of these||
4157|025|W|conditions, report them to your doctor or pharmacist.||
4157|026|W|   Being adequately hydrated before and after receiving this||
4157|027|W|medication may help reduce your risk of blood clots.||
4157|028|W|   Get medical help right away if any of these side effects||
4157|029|W|occur: shortness of breath/rapid breathing, chest/jaw/left arm||
4157|030|W|pain, unusual sweating, sudden dizziness/fainting,||
4157|031|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
4157|032|W|trouble speaking, weakness on one side of the body, sudden vision||
4157|033|W|changes, or confusion.||
4157|034|B|||
4157|035|U|USES:  This medication is used to provide protection (antibodies)||
4157|036|U|against certain virus infections (hepatitis A, measles,||
4157|037|U|chickenpox, rubella) in people who have not been vaccinated or||
4157|038|U|have not had the infection before. It is also used to strengthen||
4157|039|U|the body's natural defense system (immune system) to lower the||
4157|040|U|risk of infection in persons with a certain immune system problem||
4157|041|U|(immunoglobulin deficiency). This medication is made from healthy||
4157|042|U|human blood that has high levels of certain defensive substances||
4157|043|U|(antibodies), which help fight infections. Routine vaccination is||
4157|044|U|usually the best way to protect against infection. Talk with your||
4157|045|U|doctor about a recommended vaccination schedule.||
4157|046|B|||
4157|047|H|HOW TO USE:  This medication is injected into a muscle as||
4157|048|H|directed by your doctor. The dosage and schedule of injections||
4157|049|H|depends on your medical condition, weight, and response to||
4157|050|H|treatment. Large doses (more than 10 milliliters) should be||
4157|051|H|divided into 2 or more injections and given at separate injection||
4157|052|H|sites.||
4157|053|H|   This medication is given as soon as possible after you have||
4157|054|H|had contact with (been exposed to) someone with hepatitis A,||
4157|055|H|measles, chicken pox, or rubella. If you wait too long after||
4157|056|H|being exposed, the medication may not be effective. Not everyone||
4157|057|H|who is exposed to these infections should receive immunoglobulin.||
4157|058|H|Discuss the risks and benefits with your doctor.||
4157|059|H|   If you are traveling to an area where hepatitis A is common,||
4157|060|H|this medication may be given along with the hepatitis A vaccine||
4157|061|H|(in a separate injection). This medication will help protect you||
4157|062|H|until your body can make antibodies from the vaccine. If you||
4157|063|H|cannot use the hepatitis A vaccine, you may need to receive more||
4157|064|H|doses of immune globulin if you are staying in the area for a||
4157|065|H|long time (more than 3 months). Do not receive live virus||
4157|066|H|vaccines (such as measles vaccine) at the same time as immune||
4157|067|H|globulin. (See also Precautions section.) Ask your doctor or||
4157|068|H|pharmacist for more details and a recommended vaccination||
4157|069|H|schedule.||
4157|070|H|   If you are giving this medication to yourself at home, learn||
4157|071|H|all preparation and usage instructions from your health care||
4157|072|H|professional. Before using, check this product for particles or||
4157|073|H|discoloration. If either is present, do not use the liquid. Learn||
4157|074|H|how to store and discard medical supplies safely.||
4157|075|H|   If you are using this medication for an immune system problem,||
4157|076|H|it is given as directed by your doctor, usually every 3 to 4||
4157|077|H|weeks. Use this medication regularly in order to get the most||
4157|078|H|benefit from it. Keep all your medical/lab appointments.||
4157|079|B|||
4157|080|S|SIDE EFFECTS:  See also Warning section.||
4157|081|S|   Muscle stiffness, redness, warmth, pain, and tenderness at the||
4157|082|S|injection site may occur. Fever, chills, headache, and joint pain||
4157|083|S|may also occur. If any of these effects last or get worse, tell||
4157|084|S|your doctor or pharmacist promptly.||
4157|085|S|   Remember that this medication has been prescribed because your||
4157|086|S|doctor has judged that the benefit to you is greater than the||
4157|087|S|risk of side effects. Many people using this medication do not||
4157|088|S|have serious side effects.||
4157|089|S|   Tell your doctor right away if you have any serious side||
4157|090|S|effects, including: unusual tiredness, signs of kidney problems||
4157|091|S|(such as change in the amount of urine, pink/bloody/frothy||
4157|092|S|urine), sudden weight gain.||
4157|093|S|   A very serious allergic reaction to this drug is rare.||
4157|094|S|However, get medical help right away if you notice any symptoms||
4157|095|S|of a serious allergic reaction, including: rash, itching/swelling||
4157|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4157|097|S|breathing.||
4157|098|S|   This is not a complete list of possible side effects. If you||
4157|099|S|notice other effects not listed above, contact your doctor or||
4157|100|S|pharmacist.||
4157|101|S|   In the US -||
4157|102|S|   Call your doctor for medical advice about side effects. You||
4157|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4157|104|S|www.fda.gov/medwatch.||
4157|105|S|   In Canada - Call your doctor for medical advice about side||
4157|106|S|effects. You may report side effects to Health Canada at||
4157|107|S|1-866-234-2345.||
4157|108|B|||
4157|109|P|PRECAUTIONS:  See also Warning section.||
4157|110|P|   Before using this medication, tell your doctor or pharmacist||
4157|111|P|if you are allergic to it; or to other immunoglobulin products||
4157|112|P|(such as IVIG); or if you have any other allergies. This product||
4157|113|P|may contain inactive ingredients, which can cause allergic||
4157|114|P|reactions or other problems. Talk to your pharmacist for more||
4157|115|P|details.||
4157|116|P|   Before using this medication, tell your doctor or pharmacist||
4157|117|P|your medical history, especially of: a certain immune system||
4157|118|P|problem (immunoglobulin A deficiency), bleeding/blood clotting||
4157|119|P|problems (such as low platelets, hemophilia), kidney disease.||
4157|120|P|   Tell your doctor of any recent or planned||
4157|121|P|immunizations/vaccinations. This medication may prevent a good||
4157|122|P|response to certain live viral vaccines (such as measles, mumps,||
4157|123|P|rubella, varicella). If you have recently received any of these||
4157|124|P|vaccines, your doctor may have you tested for a response or have||
4157|125|P|you vaccinated again later. If you plan on getting any of these||
4157|126|P|vaccines, your doctor will instruct you about the best time to||
4157|127|P|receive them so you get a good response.||
4157|128|P|   This medication is made from human blood. Even though the||
4157|129|P|blood is carefully tested, and this medication goes through a||
4157|130|P|special manufacturing process, there is an extremely small chance||
4157|131|P|that you may get infections from the medication (for example,||
4157|132|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
4157|133|P|more information.||
4157|134|P|   Before having surgery, tell your doctor or dentist about all||
4157|135|P|the products you use (including prescription drugs,||
4157|136|P|nonprescription drugs, and herbal products).||
4157|137|P|   During pregnancy, this medication should be used only when||
4157|138|P|clearly needed. Discuss the risks and benefits with your doctor.||
4157|139|P|   It is unknown if this drug passes into breast milk. Consult||
4157|140|P|your doctor before breastfeeding.||
4157|141|B|||
4157|142|I|DRUG INTERACTIONS:  See also Warning section.||
4157|143|I|   Drug interactions may change how your medications work or||
4157|144|I|increase your risk for serious side effects. This document does||
4157|145|I|not contain all possible drug interactions. Keep a list of all||
4157|146|I|the products you use (including prescription/nonprescription||
4157|147|I|drugs and herbal products) and share it with your doctor and||
4157|148|I|pharmacist. Do not start, stop, or change the dosage of any||
4157|149|I|medicines without your doctor's approval.||
4157|150|I|   Some products that may interact with this drug include: drugs||
4157|151|I|that may harm the kidneys (including aminoglycosides such as||
4157|152|I|gentamicin).||
4157|153|B|||
4157|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4157|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4157|156|O|poison control center right away. US residents can call||
4157|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4157|158|B|||
4157|159|N|NOTES:  Do not share this medication with others.||
4157|160|N|   Lab and/or medical tests (such as kidney function) may be done||
4157|161|N|while you are using this medication. Keep all medical and lab||
4157|162|N|appointments. Consult your doctor for more details.||
4157|163|B|||
4157|164|D|MISSED DOSE:  Because this medication provides protection for||
4157|165|D|only a limited time (1 to 3 months), additional doses may be||
4157|166|D|necessary based on the situation. Discuss this with your doctor.||
4157|167|B|||
4157|168|R|STORAGE:  Store in the refrigerator. Do not freeze. Discard any||
4157|169|R|unused portion. Keep all medications away from children and pets.||
4157|170|R|   Do not flush medications down the toilet or pour them into a||
4157|171|R|drain unless instructed to do so. Properly discard this product||
4157|172|R|when it is expired or no longer needed. Consult your pharmacist||
4157|173|R|or local waste disposal company.||
4157|174|B|||
4157|175|A|Information last revised June 2025.||
4157|176|A|Copyright(c) 2025 First Databank, Inc.||
4157|177|B|||
4169|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4169|002|Z|does NOT have all possible information about this product. This||
4169|003|Z|information does not assure that this product is safe, effective,||
4169|004|Z|or appropriate for you. This information is not individual||
4169|005|Z|medical advice and does not substitute for the advice of your||
4169|006|Z|health care professional. Always ask your health care||
4169|007|Z|professional for complete information about this product and your||
4169|008|Z|specific health needs.||
4169|009|B|||
4169|010|T|HEPATITIS A VACCINE - INJECTION||
4169|011|F|(hep-uh-TIE-tuss A)||
4169|012|B|||
4169|013|C|COMMON BRAND NAME(S): Havrix, Vaqta||
4169|014|B|||
4169|015|U|USES:  This vaccine is used to help prevent hepatitis A.||
4169|016|U|Hepatitis A infection can be mild with no symptoms or a severe||
4169|017|U|illness that can rarely cause liver failure and death.||
4169|018|U|Vaccination is the best way to protect against this infection.||
4169|019|U|This vaccine works by increasing the body's natural defense||
4169|020|U|(immunity) against the virus.||
4169|021|U|   The vaccine is recommended for people aged 12 months and||
4169|022|U|older, especially those at an increased risk of getting the||
4169|023|U|infection. Those at an increased risk include people who live||
4169|024|U|with or spend much time with people with hepatitis A infections,||
4169|025|U|institutional or daycare workers, lab workers, people with||
4169|026|U|multiple sex partners, men who have sex with men, sex workers,||
4169|027|U|injecting and non-injecting drug abusers, and people traveling to||
4169|028|U|high-risk areas.||
4169|029|U|   Vaccines may not fully protect everyone who receives them.||
4169|030|B|||
4169|031|H|HOW TO USE:  Read all vaccine information available from your||
4169|032|H|health care professional before receiving the vaccine. If you||
4169|033|H|have any questions, ask your health care professional.||
4169|034|H|   This vaccine is given by injection into a muscle by a health||
4169|035|H|care professional. It is given in the upper arm for children and||
4169|036|H|adults and in the thigh for infants.||
4169|037|H|   Vaccines are usually given in a series of doses to provide the||
4169|038|H|best protection. Closely follow the vaccination schedule provided||
4169|039|H|by your health care professional. To help you remember, mark your||
4169|040|H|calendar with a reminder.||
4169|041|H|   This vaccine may be given at the same time as other vaccines.||
4169|042|B|||
4169|043|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
4169|044|S|fever, tiredness, headache, nausea, and loss of appetite may||
4169|045|S|occur. If any of these effects last or get worse, tell your||
4169|046|S|health care professional promptly.||
4169|047|S|   Rarely, some people have symptoms such as fainting, dizziness,||
4169|048|S|vision changes, or ringing in the ears just after getting a||
4169|049|S|vaccine injection. Tell your health care professional right away||
4169|050|S|if you have any of these symptoms. Sitting or lying down may||
4169|051|S|help, since these symptoms usually don't last long.||
4169|052|S|   Remember that this vaccine has been prescribed because your||
4169|053|S|health care professional has judged that the benefit to you is||
4169|054|S|greater than the risk of side effects. Many people using this||
4169|055|S|vaccine do not have serious side effects.||
4169|056|S|   A very serious allergic reaction to this vaccine is rare.||
4169|057|S|However, get medical help right away if you notice any symptoms||
4169|058|S|of a serious allergic reaction, including: rash, itching/swelling||
4169|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4169|060|S|breathing.||
4169|061|S|   This is not a complete list of possible side effects. If you||
4169|062|S|notice other effects not listed above, contact your health care||
4169|063|S|professional.||
4169|064|S|   Contact the health care professional for medical advice about||
4169|065|S|side effects. The following numbers do not provide medical||
4169|066|S|advice, but in the US you may report side effects to the Vaccine||
4169|067|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
4169|068|S|Canada, you may call the Vaccine Safety Section at Public Health||
4169|069|S|Agency of Canada at 1-866-844-0018.||
4169|070|B|||
4169|071|P|PRECAUTIONS:  Before you receive this vaccine, tell your health||
4169|072|P|care professional if you are allergic to it; or if you have any||
4169|073|P|other allergies. This product may contain inactive ingredients||
4169|074|P|(such as neomycin, formalin, latex in some vials/prefilled||
4169|075|P|syringes), which can cause allergic reactions or other problems.||
4169|076|P|Talk to your health care professional for more details.||
4169|077|P|   Before receiving this vaccine, tell your health care||
4169|078|P|professional your medical history, especially of: current||
4169|079|P|fever/illness, immune system disorders (such as due to HIV||
4169|080|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
4169|081|P|radiation treatment), vaccination history (including previous||
4169|082|P|reactions to any vaccines).||
4169|083|P|   During pregnancy, this vaccine should be used only when||
4169|084|P|clearly needed. Discuss the risks and benefits with your health||
4169|085|P|care professional.||
4169|086|P|   It is unknown if this vaccine passes into breast milk. Consult||
4169|087|P|your health care professional before breastfeeding.||
4169|088|B|||
4169|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4169|090|I|medications work or increase your risk for serious side effects.||
4169|091|I|This document does not contain all possible drug interactions.||
4169|092|I|Keep a list of all the products you use (including||
4169|093|I|prescription/nonprescription drugs and herbal products) and share||
4169|094|I|it with your health care professional. Do not start, stop, or||
4169|095|I|change the dosage of any medicines without your doctor's||
4169|096|I|approval.||
4169|097|I|   Some products that may interact with this vaccine are: drugs||
4169|098|I|that weaken the immune system (including cyclosporine,||
4169|099|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
4169|100|I|prednisone).||
4169|101|B|||
4169|102|O|OVERDOSE:  Not applicable.||
4169|103|B|||
4169|104|N|NOTES:  Lab and/or medical tests (such as hepatitis A antibody||
4169|105|N|levels) may be done while you are using this vaccine. Keep all||
4169|106|N|medical and lab appointments. Consult your health care||
4169|107|N|professional for more details.||
4169|108|N|   Keep vaccine records for yourself and your children and||
4169|109|N|provide them to the health care professionals to prevent||
4169|110|N|unnecessary re-vaccinations.||
4169|111|B|||
4169|112|D|MISSED DOSE:  It is important that you get each vaccination as||
4169|113|D|scheduled. Ask when you should get each dose and mark your||
4169|114|D|calendar with a reminder. If you miss a dose, call the health||
4169|115|D|care professional to reschedule.||
4169|116|B|||
4169|117|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
4169|118|R|medications away from children and pets.||
4169|119|R|   Do not flush medications down the toilet or pour them into a||
4169|120|R|drain unless instructed to do so. Properly discard this product||
4169|121|R|when it is expired or no longer needed. Consult your pharmacist||
4169|122|R|or local waste disposal company.||
4169|123|B|||
4169|124|A|Information last revised January 2025.||
4169|125|A|Copyright(c) 2025 First Databank, Inc.||
4169|126|B|||
4170|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4170|002|Z|does NOT have all possible information about this product. This||
4170|003|Z|information does not assure that this product is safe, effective,||
4170|004|Z|or appropriate for you. This information is not individual||
4170|005|Z|medical advice and does not substitute for the advice of your||
4170|006|Z|health care professional. Always ask your health care||
4170|007|Z|professional for complete information about this product and your||
4170|008|Z|specific health needs.||
4170|009|B|||
4170|010|T|PRAMOXINE/HYDROCORTISONE FOAM - TOPICAL||
4170|011|F|(pram-OX-een/hi-dro-KOR-tih-sown)||
4170|012|B|||
4170|013|C|COMMON BRAND NAME(S): Epifoam||
4170|014|B|||
4170|015|U|USES:  This product contains 2 medications. Pramoxine is an||
4170|016|U|anesthetic that is used on the skin to relieve minor pain,||
4170|017|U|itching, and discomfort. It works by temporarily numbing the||
4170|018|U|area. Hydrocortisone is a corticosteroid that reduces redness,||
4170|019|U|swelling, and itching. This combination medication is used to||
4170|020|U|treat certain skin conditions such as eczema, psoriasis, rash,||
4170|021|U|cuts, scrapes, insect bites, or minor burns. This product is||
4170|022|U|available in different strengths and forms (such as aerosol foam,||
4170|023|U|cream, ointment, lotion). The type of medication used depends on||
4170|024|U|the location of your condition and the type of skin problem being||
4170|025|U|treated. Creams are the most often used form. Lotions may be||
4170|026|U|better for hairy areas. Ointments may be better for dry areas and||
4170|027|U|when a stronger effect or skin protection is desired. Foams can||
4170|028|U|be easier and less messy to apply.||
4170|029|B|||
4170|030|H|HOW TO USE:  Follow all instructions in the product package,||
4170|031|H|including any instructions for cleaning the container after use.||
4170|032|H|Before each use, shake the foam canister well for 5-10 seconds.||
4170|033|H|Before applying the medication, clean the affected area with mild||
4170|034|H|soap and water, rinse well, and pat dry. Apply a small amount of||
4170|035|H|the foam to the affected area as directed by your doctor, usually||
4170|036|H|3 to 4 times a day. You may need to press the applicator a few||
4170|037|H|times before foam appears. You can apply the foam directly to the||
4170|038|H|area, or apply a small amount to a pad and use it to apply the||
4170|039|H|foam to the affected area. Do not use the foam or insert any part||
4170|040|H|of the foam canister in the anus or vagina.||
4170|041|H|   This medication is for use on the skin only, as directed by||
4170|042|H|your doctor. Do not use more of this product, use it more often,||
4170|043|H|or keep using it longer than prescribed because doing so may||
4170|044|H|increase the risk of side effects. Wash hands immediately after||
4170|045|H|use, unless the area being treated includes the hands. Avoid||
4170|046|H|getting the product in your eyes, nose, ears or mouth. If the||
4170|047|H|medication gets in these areas, rinse the area immediately with||
4170|048|H|clean water.||
4170|049|H|   Do not cover the area with waterproof bandages or plastic,||
4170|050|H|apply heat, or use the product on large areas of the body unless||
4170|051|H|directed to do so by your doctor. If used in the diaper area on||
4170|052|H|an infant, do not use tight-fitting diapers or plastic pants.||
4170|053|H|These may increase the risk of side effects.||
4170|054|H|   How often the medication is applied and for how long depends||
4170|055|H|on your condition and response to treatment. Use this medication||
4170|056|H|regularly in order to get the most benefit from it. To help you||
4170|057|H|remember, use it at the same times each day.||
4170|058|H|   If you have been using this medication for a long time or in||
4170|059|H|high doses, do not suddenly stop using it without your doctor's||
4170|060|H|approval. Some conditions may become worse when this drug is||
4170|061|H|suddenly stopped. Your dose may need to be gradually decreased.||
4170|062|H|   Tell your doctor if your condition does not get better or if||
4170|063|H|it gets worse.||
4170|064|B|||
4170|065|S|SIDE EFFECTS:  Redness, burning, or itching at the application||
4170|066|S|site may occur. If any of these effects last or get worse,||
4170|067|S|contact your doctor or pharmacist promptly.||
4170|068|S|   Remember that this medication has been prescribed because your||
4170|069|S|doctor has judged that the benefit to you is greater than the||
4170|070|S|risk of side effects. Many people using this medication do not||
4170|071|S|have serious side effects.||
4170|072|S|   Tell your doctor right away if you have any serious side||
4170|073|S|effects, including: change in skin appearance (such as its color,||
4170|074|S|thickness), signs of skin infection (such as a feeling of heat at||
4170|075|S|the area, tenderness, pus), signs of infection (such as sore||
4170|076|S|throat that doesn't go away, fever, chills).||
4170|077|S|   A very serious allergic reaction to this drug is rare.||
4170|078|S|However, get medical help right away if you notice any symptoms||
4170|079|S|of a serious allergic reaction, including: rash, itching/swelling||
4170|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4170|081|S|breathing.||
4170|082|S|   This is not a complete list of possible side effects. If you||
4170|083|S|notice other effects not listed above, contact your doctor or||
4170|084|S|pharmacist.||
4170|085|S|   In the US -||
4170|086|S|   Call your doctor for medical advice about side effects. You||
4170|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4170|088|S|www.fda.gov/medwatch.||
4170|089|S|   In Canada - Call your doctor for medical advice about side||
4170|090|S|effects. You may report side effects to Health Canada at||
4170|091|S|1-866-234-2345.||
4170|092|B|||
4170|093|P|PRECAUTIONS:  Before using this product, tell your doctor or||
4170|094|P|pharmacist if you are allergic to pramoxine; or to||
4170|095|P|hydrocortisone; or if you have any other allergies. This product||
4170|096|P|may contain inactive ingredients, which can cause allergic||
4170|097|P|reactions or other problems. Talk to your pharmacist for more||
4170|098|P|details.||
4170|099|P|   Before using this medication, tell your doctor or pharmacist||
4170|100|P|your medical history, especially of: immune system problems (such||
4170|101|P|as low white blood cells), diabetes, infections (especially skin||
4170|102|P|infections), kidney disease, liver disease.||
4170|103|P|   Children may be more sensitive to the effects of too much||
4170|104|P|corticosteroid medication. Consult your doctor for more details.||
4170|105|P|   During pregnancy, this medication should be used only when||
4170|106|P|clearly needed. It should not be used for a long time or in large||
4170|107|P|amounts. Discuss the risks and benefits with your doctor.||
4170|108|P|   It is unknown if this medication passes into breast milk.||
4170|109|P|Consult your doctor before breastfeeding.||
4170|110|B|||
4170|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4170|112|I|medications work or increase your risk for serious side effects.||
4170|113|I|This document does not contain all possible drug interactions.||
4170|114|I|Keep a list of all the products you use (including||
4170|115|I|prescription/nonprescription drugs and herbal products) and share||
4170|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
4170|117|I|the dosage of any medicines without your doctor's approval.||
4170|118|B|||
4170|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
4170|120|O|has overdosed and has serious symptoms such as passing out or||
4170|121|O|trouble breathing, call 911. Otherwise, call a poison control||
4170|122|O|center right away. US residents can call 1-800-222-1222. Canada||
4170|123|O|residents can call 1-844-764-7669.||
4170|124|B|||
4170|125|N|NOTES:  Do not share this medication with others.||
4170|126|N|   This medication has been prescribed for your current condition||
4170|127|N|only. Do not use it later for another condition unless told to do||
4170|128|N|so by your doctor. A different medication may be necessary in||
4170|129|N|that case.||
4170|130|N|   Tell all your doctors that you use (or have used) this||
4170|131|N|medication.||
4170|132|B|||
4170|133|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
4170|134|D|unless it is almost time for the next dose. In that case, skip||
4170|135|D|the missed dose. Use your next dose at the regular time. Do not||
4170|136|D|double the dose to catch up.||
4170|137|B|||
4170|138|R|STORAGE:  Store the foam canister upright at room temperature||
4170|139|R|away from high heat. Do not refrigerate. The contents of this||
4170|140|R|container are under pressure. Do not burn or puncture the aerosol||
4170|141|R|container. Keep all medications away from children and pets.||
4170|142|R|   Do not flush medications down the toilet or pour them into a||
4170|143|R|drain unless instructed to do so. Properly discard this product||
4170|144|R|when it is expired or no longer needed. Consult your pharmacist||
4170|145|R|or local waste disposal company.||
4170|146|B|||
4170|147|A|Information last revised May 2025.||
4170|148|A|Copyright(c) 2025 First Databank, Inc.||
4170|149|B|||
4172|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4172|002|Z|does NOT have all possible information about this product. This||
4172|003|Z|information does not assure that this product is safe, effective,||
4172|004|Z|or appropriate for you. This information is not individual||
4172|005|Z|medical advice and does not substitute for the advice of your||
4172|006|Z|health care professional. Always ask your health care||
4172|007|Z|professional for complete information about this product and your||
4172|008|Z|specific health needs.||
4172|009|B|||
4172|010|T|DEXTROMETHORPHAN/DECONGESTANT/ANTIHISTAMINE - ORAL||
4172|011|B|||
4172|012|U|USES:  This combination medication is used to treat symptoms||
4172|013|U|caused by the common cold, flu, allergies, hay fever, or other||
4172|014|U|breathing illnesses (such as sinusitis, bronchitis).||
4172|015|U|Dextromethorphan is a cough suppressant that affects a certain||
4172|016|U|part of the brain (cough center), reducing the urge to cough.||
4172|017|U|Decongestants help relieve stuffy nose symptoms. Antihistamines||
4172|018|U|relieve watery eyes, itchy eyes/nose/throat, runny nose, and||
4172|019|U|sneezing.||
4172|020|U|   Cough-and-cold products have not been shown to be safe or||
4172|021|U|effective in children younger than 6 years. Do not use this||
4172|022|U|product to treat cold symptoms in children younger than 6 years||
4172|023|U|unless specifically directed by the doctor. Some products (such||
4172|024|U|as long-acting tablets/capsules) are not recommended for use in||
4172|025|U|children younger than 12 years. Ask your doctor or pharmacist for||
4172|026|U|more details about using your product safely.||
4172|027|U|   These products do not cure or shorten the length of the common||
4172|028|U|cold and may cause serious side effects. To decrease the risk for||
4172|029|U|serious side effects, carefully follow all dosage directions. Do||
4172|030|U|not use this product to make a child sleepy. Do not give other||
4172|031|U|cough-and-cold medication that might contain the same or similar||
4172|032|U|ingredients (see also Drug Interactions section). Ask the doctor||
4172|033|U|or pharmacist about other ways to relieve cough and cold symptoms||
4172|034|U|(such as drinking enough fluids, using a humidifier or saline||
4172|035|U|nose drops/spray).||
4172|036|B|||
4172|037|H|HOW TO USE:  If you are taking the over-the-counter product, read||
4172|038|H|all directions on the product package before taking this||
4172|039|H|medication. If you have any questions, consult your pharmacist.||
4172|040|H|If your doctor has prescribed this medication, take it as||
4172|041|H|directed.||
4172|042|H|   Take this medication by mouth with or without food with a full||
4172|043|H|glass of water (8 ounces or 240 milliliters) or as directed by||
4172|044|H|your doctor. This medication may be taken with food or milk if||
4172|045|H|stomach upset occurs.||
4172|046|H|   If you are using the liquid form, use a medication measuring||
4172|047|H|device to carefully measure the prescribed dose. Do not use a||
4172|048|H|household spoon. If your liquid form is a suspension, shake the||
4172|049|H|bottle well before each dose.||
4172|050|H|   If you are taking the extended-release capsules, swallow them||
4172|051|H|whole. Do not crush or chew extended-release capsules or tablets.||
4172|052|H|Doing so can release all of the drug at once, increasing the risk||
4172|053|H|of side effects. Also, do not split extended-release tablets||
4172|054|H|unless they have a score line and your doctor or pharmacist tells||
4172|055|H|you to do so. Swallow the whole or split tablet without crushing||
4172|056|H|or chewing.||
4172|057|H|   Chewable forms of this medication should be chewed thoroughly||
4172|058|H|before swallowing.||
4172|059|H|   If you are taking the powder, mix it thoroughly in the proper||
4172|060|H|amount of liquid and stir well. Drink all of the liquid right||
4172|061|H|away. Do not prepare a supply for future use.||
4172|062|H|   The dosage is based on your age, medical condition and||
4172|063|H|response to treatment. If you are taking this medication for||
4172|064|H|allergy or hay fever symptoms, take it regularly in order to get||
4172|065|H|the most benefit from it.||
4172|066|H|   Improper use of this medication (abuse) may result in serious||
4172|067|H|harm (such as brain damage, seizure, death). Do not increase your||
4172|068|H|dose, take it more often, or use it for a longer time than||
4172|069|H|directed.||
4172|070|H|   Tell your doctor if your condition lasts or gets worse.||
4172|071|B|||
4172|072|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, blurred vision,||
4172|073|S|upset stomach, nausea, constipation, or dry mouth/nose/throat may||
4172|074|S|occur. If any of these effects last or get worse, notify your||
4172|075|S|doctor or pharmacist promptly.||
4172|076|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
4172|077|S|chips, chew (sugarless) gum, drink water, or use a saliva||
4172|078|S|substitute. This medication can dry up and thicken mucus in your||
4172|079|S|lungs, making it more difficult to breathe and clear your lungs.||
4172|080|S|To help prevent this effect, drink plenty of fluids unless||
4172|081|S|otherwise directed by your doctor.||
4172|082|S|   To reduce the risk of dizziness and lightheadedness, get up||
4172|083|S|slowly when rising from a sitting or lying position.||
4172|084|S|   If your doctor has prescribed this medication, remember that||
4172|085|S|your doctor has judged that the benefit to you is greater than||
4172|086|S|the risk of side effects. Many people using this medication do||
4172|087|S|not have serious side effects.||
4172|088|S|   This medication may raise your blood pressure. Check your||
4172|089|S|blood pressure regularly and tell your doctor if the results are||
4172|090|S|high.||
4172|091|S|   Tell your doctor right away if you have any serious side||
4172|092|S|effects, including: mental/mood changes (such as confusion,||
4172|093|S|hallucinations), ringing in the ears, shaking (tremors), trouble||
4172|094|S|urinating, weakness, easy bruising/bleeding, fast/slow/irregular||
4172|095|S|heartbeat, seizure.||
4172|096|S|   A very serious allergic reaction to this drug is rare.||
4172|097|S|However, get medical help right away if you notice any symptoms||
4172|098|S|of a serious allergic reaction, including: rash, itching/swelling||
4172|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4172|100|S|breathing.||
4172|101|S|   This is not a complete list of possible side effects. If you||
4172|102|S|notice other effects not listed above, contact your doctor or||
4172|103|S|pharmacist.||
4172|104|S|   In the US -||
4172|105|S|   Call your doctor for medical advice about side effects. You||
4172|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4172|107|S|www.fda.gov/medwatch.||
4172|108|S|   In Canada - Call your doctor for medical advice about side||
4172|109|S|effects. You may report side effects to Health Canada at||
4172|110|S|1-866-234-2345.||
4172|111|B|||
4172|112|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
4172|113|P|pharmacist if you are allergic to it; or if you have any other||
4172|114|P|allergies. This product may contain inactive ingredients, which||
4172|115|P|can cause allergic reactions or other problems. Talk to your||
4172|116|P|pharmacist for more details.||
4172|117|P|   Before using this medication, tell your doctor or pharmacist||
4172|118|P|your medical history, especially of: breathing problems (such as||
4172|119|P|asthma, emphysema), diabetes, a certain eye problem (glaucoma),||
4172|120|P|heart problems, high blood pressure, kidney problems, liver||
4172|121|P|disease, seizures, stomach/intestinal problems (such as ulcers,||
4172|122|P|blockage), overactive thyroid (hyperthyroidism), urination||
4172|123|P|problems (such as trouble urinating due to enlarged prostate,||
4172|124|P|urinary retention).||
4172|125|P|   This drug may make you dizzy or drowsy or blur your vision.||
4172|126|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
4172|127|P|drowsy. Do not drive, use machinery, or do anything that needs||
4172|128|P|alertness or clear vision until you can do it safely. Limit||
4172|129|P|alcoholic beverages. Talk to your doctor if you are using||
4172|130|P|marijuana (cannabis).||
4172|131|P|   This medicine may contain aspartame. If you have||
4172|132|P|phenylketonuria (PKU) or any other condition that requires you to||
4172|133|P|restrict your intake of aspartame (or phenylalanine), consult||
4172|134|P|your doctor or pharmacist regarding the safe use of this||
4172|135|P|medicine.||
4172|136|P|   Liquid preparations of this product may contain sugar and/or||
4172|137|P|alcohol. Caution is advised if you have diabetes, alcohol||
4172|138|P|dependence, or liver disease. Ask your doctor or pharmacist about||
4172|139|P|the safe use of this product.||
4172|140|P|   Before having surgery, tell your doctor or dentist about all||
4172|141|P|the products you use (including prescription drugs,||
4172|142|P|nonprescription drugs, and herbal products).||
4172|143|P|   Older adults may be more sensitive to the side effects of this||
4172|144|P|drug, especially dizziness, drowsiness, mental/mood changes,||
4172|145|P|constipation, fast heartbeat, trouble urinating, or blood||
4172|146|P|pressure changes. Dizziness, drowsiness, and confusion can||
4172|147|P|increase the risk of falling.||
4172|148|P|   Children may be more sensitive to the side effects of||
4172|149|P|antihistamines. In young children, this medication may cause||
4172|150|P|agitation/excitement instead of drowsiness.||
4172|151|P|   During pregnancy, this medication should be used only when||
4172|152|P|clearly needed. Discuss the risks and benefits with your doctor.||
4172|153|P|   This medication may pass into breast milk. Consult your doctor||
4172|154|P|before breastfeeding.||
4172|155|B|||
4172|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4172|157|I|medications work or increase your risk for serious side effects.||
4172|158|I|This document does not contain all possible drug interactions.||
4172|159|I|Keep a list of all the products you use (including||
4172|160|I|prescription/nonprescription drugs and herbal products) and share||
4172|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
4172|162|I|the dosage of any medicines without your doctor's approval.||
4172|163|I|   Taking certain MAO inhibitors with this medication may cause a||
4172|164|I|serious (possibly fatal) drug interaction. Avoid taking||
4172|165|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
4172|166|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
4172|167|I|tranylcypromine during treatment with this medication. Most MAO||
4172|168|I|inhibitors should also not be taken for two weeks before and||
4172|169|I|after treatment with this medication. Ask your doctor when to||
4172|170|I|start or stop taking this medication.||
4172|171|I|   Some products that may interact with this drug are:||
4172|172|I|antihistamines applied to the skin (such as diphenhydramine||
4172|173|I|cream, ointment, spray), rolapitant.||
4172|174|I|   Tell your doctor or pharmacist if you are taking other||
4172|175|I|products that cause drowsiness such as opioid pain or cough||
4172|176|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4172|177|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4172|178|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4172|179|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
4172|180|I|diphenhydramine).||
4172|181|I|   Check the labels on all your medicines (such as allergy or||
4172|182|I|cough-and-cold products) because they may contain ingredients||
4172|183|I|that cause drowsiness. Ask your pharmacist about using those||
4172|184|I|products safely.||
4172|185|I|   This medication may interfere with certain medical/lab tests||
4172|186|I|(such as brain scan for Parkinson's disease, urine drug screening||
4172|187|I|tests, allergy skin test), possibly causing false test results.||
4172|188|I|Make sure lab personnel and all your doctors know you use this||
4172|189|I|drug.||
4172|190|B|||
4172|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4172|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4172|193|O|poison control center right away. US residents can call||
4172|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4172|195|O|Symptoms of overdose may include: agitation, confusion, flushing,||
4172|196|O|hallucinations, large pupils, muscle twitching, seizures. In||
4172|197|O|children, excitement may occur first, and may be followed by loss||
4172|198|O|of coordination, drowsiness, loss of consciousness, seizures.||
4172|199|B|||
4172|200|N|NOTES:  If your doctor has prescribed this medication, do not||
4172|201|N|share it with others.||
4172|202|N|   Keep all medical and lab appointments.||
4172|203|B|||
4172|204|D|MISSED DOSE:  If you are taking this product on a regular||
4172|205|D|schedule and miss a dose, take it as soon as you remember. If it||
4172|206|D|is near the time of the next dose, skip the missed dose. Take||
4172|207|D|your next dose at the regular time. Do not double the dose to||
4172|208|D|catch up.||
4172|209|B|||
4172|210|R|STORAGE:  Store at room temperature away from light and moisture.||
4172|211|R|Do not store in the bathroom. Do not freeze liquid forms of this||
4172|212|R|medication. Keep all medications away from children and pets.||
4172|213|R|   Do not flush medications down the toilet or pour them into a||
4172|214|R|drain unless instructed to do so. Properly discard this product||
4172|215|R|when it is expired or no longer needed. Consult your pharmacist||
4172|216|R|or local waste disposal company.||
4172|217|B|||
4172|218|A|Information last revised July 2025.||
4172|219|A|Copyright(c) 2025 First Databank, Inc.||
4172|220|B|||
4174|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4174|002|Z|does NOT have all possible information about this product. This||
4174|003|Z|information does not assure that this product is safe, effective,||
4174|004|Z|or appropriate for you. This information is not individual||
4174|005|Z|medical advice and does not substitute for the advice of your||
4174|006|Z|health care professional. Always ask your health care||
4174|007|Z|professional for complete information about this product and your||
4174|008|Z|specific health needs.||
4174|009|B|||
4174|010|T|CALCITONIN SPRAY - NASAL||
4174|011|F|(KAL-si-TOE-nin)||
4174|012|B|||
4174|013|C|COMMON BRAND NAME(S): Fortical, Miacalcin||
4174|014|B|||
4174|015|U|USES:  This medication is used to treat brittle bone disease||
4174|016|U|(osteoporosis) in women who are at least 5 years past "the change||
4174|017|U|of life" (menopause). Calcitonin works by slowing bone loss to||
4174|018|U|help maintain strong bones and reduce your risk of fractures.||
4174|019|U|   This product has been withdrawn from the Canadian market due||
4174|020|U|to safety problems.||
4174|021|B|||
4174|022|H|HOW TO USE:  Read the patient and product information sheets if||
4174|023|H|available from your pharmacist before you start using calcitonin||
4174|024|H|and each time you get a refill. If you have any questions, ask||
4174|025|H|your doctor or pharmacist.||
4174|026|H|   This medication is for use in the nose as directed, usually||
4174|027|H|one spray in one nostril each day, alternating nostrils daily. It||
4174|028|H|is recommended to use this medication at the lowest effective||
4174|029|H|dosage and for the shortest possible duration to treat your||
4174|030|H|condition. Patients treated long-term with this medication have||
4174|031|H|shown a rare risk of developing cancer. Discuss the benefits and||
4174|032|H|risks of long term treatment with this medication.||
4174|033|H|   Remove a new bottle from the refrigerator and allow it to||
4174|034|H|reach room temperature. Follow the instructions on how to prime||
4174|035|H|the pump the first time you use a new bottle. Once the pump is||
4174|036|H|primed, it does not have to be reprimed if the bottle is properly||
4174|037|H|stored in an upright position. Consult your pharmacist if you||
4174|038|H|have any questions.||
4174|039|H|   To use the nasal spray, remove the protective cap, keep your||
4174|040|H|head upright and insert the tip into a nostril. Press down firmly||
4174|041|H|on the pump to deliver the medication. Replace the protective||
4174|042|H|cap. Use the other nostril the next day.||
4174|043|H|   Use this medication regularly in order to get the most benefit||
4174|044|H|from it. Remember to use it at the same time each day.||
4174|045|B|||
4174|046|S|SIDE EFFECTS:  (See also How to Use section).||
4174|047|S|   Runny nose, nose bleeds, nasal irritation, dry nose with||
4174|048|S|crusting, headache, dizziness, nausea, flushing of the face, or||
4174|049|S|back pain may occur. If any of these effects last or get worse,||
4174|050|S|notify your doctor or pharmacist promptly.||
4174|051|S|   Remember that this medication has been prescribed because your||
4174|052|S|doctor has judged that the benefit to you is greater than the||
4174|053|S|risk of side effects. Many people using this medication do not||
4174|054|S|have serious side effects.||
4174|055|S|   Tell your doctor right away if you have any serious side||
4174|056|S|effects, including: nasal sores, muscle cramps/spasms,||
4174|057|S|numbness/tingling of the arms/legs.||
4174|058|S|   Get medical help right away if you have any very serious side||
4174|059|S|effects, including: seizures.||
4174|060|S|   A very serious allergic reaction to this drug is rare.||
4174|061|S|However, get medical help right away if you notice any symptoms||
4174|062|S|of a serious allergic reaction, including: rash, itching/swelling||
4174|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4174|064|S|breathing.||
4174|065|S|   This is not a complete list of possible side effects. If you||
4174|066|S|notice other effects not listed above, contact your doctor or||
4174|067|S|pharmacist.||
4174|068|S|   In the US -||
4174|069|S|   Call your doctor for medical advice about side effects. You||
4174|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4174|071|S|www.fda.gov/medwatch.||
4174|072|S|   In Canada - Call your doctor for medical advice about side||
4174|073|S|effects. You may report side effects to Health Canada at||
4174|074|S|1-866-234-2345.||
4174|075|B|||
4174|076|P|PRECAUTIONS:  Before taking calcitonin, tell your doctor or||
4174|077|P|pharmacist if you are allergic to it; or if you have any other||
4174|078|P|allergies. This product may contain inactive ingredients, which||
4174|079|P|can cause allergic reactions or other problems. Talk to your||
4174|080|P|pharmacist for more details.||
4174|081|P|   Before using this medication, tell your doctor or pharmacist||
4174|082|P|your medical history, especially of: low level of calcium in the||
4174|083|P|blood.||
4174|084|P|   This medication is used mainly in women after menopause. It is||
4174|085|P|unlikely to be used during pregnancy or breastfeeding. Consult||
4174|086|P|your doctor if you have any questions about this product.||
4174|087|B|||
4174|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4174|089|I|medications work or increase your risk for serious side effects.||
4174|090|I|This document does not contain all possible drug interactions.||
4174|091|I|Keep a list of all the products you use (including||
4174|092|I|prescription/nonprescription drugs and herbal products) and share||
4174|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
4174|094|I|the dosage of any medicines without your doctor's approval.||
4174|095|I|   A product that may interact with this drug is: lithium.||
4174|096|B|||
4174|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4174|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4174|099|O|poison control center right away. US residents can call||
4174|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4174|101|B|||
4174|102|N|NOTES:  Do not share this medication with others.||
4174|103|N|   Lifestyle changes that help promote healthy bones include||
4174|104|N|increasing weight-bearing exercise, stopping smoking, limiting||
4174|105|N|alcohol, and eating well-balanced meals that contain adequate||
4174|106|N|calcium and vitamin D. Since you may also need to take calcium||
4174|107|N|and vitamin D supplements and make lifestyle changes, consult||
4174|108|N|your doctor for specific advice.||
4174|109|N|   Lab and/or medical tests (such as bone density tests, nasal||
4174|110|N|exams) should be done while you are using this medication. Keep||
4174|111|N|all medical and lab appointments. Consult your doctor for more||
4174|112|N|details.||
4174|113|B|||
4174|114|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4174|115|D|If it is near the time of the next dose, skip the missed dose.||
4174|116|D|Use your next dose at the regular time. Do not double the dose to||
4174|117|D|catch up.||
4174|118|B|||
4174|119|R|STORAGE:  Store unopened bottles in the refrigerator. Do not||
4174|120|R|freeze. Once the bottle is opened and the pump is primed, store||
4174|121|R|at room temperature in an upright position away from light and||
4174|122|R|moisture. Discard the unused portion after the number of||
4174|123|R|days/doses noted on the package. If you are unsure when to||
4174|124|R|discard your brand, ask your pharmacist. Keep all medications||
4174|125|R|away from children and pets.||
4174|126|R|   Do not flush medications down the toilet or pour them into a||
4174|127|R|drain unless instructed to do so. Properly discard this product||
4174|128|R|when it is expired or no longer needed. Consult your pharmacist||
4174|129|R|or local waste disposal company.||
4174|130|B|||
4174|131|A|Information last revised May 2024.||
4174|132|A|Copyright(c) 2025 First Databank, Inc.||
4174|133|B|||
4179|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4179|002|Z|does NOT have all possible information about this product. This||
4179|003|Z|information does not assure that this product is safe, effective,||
4179|004|Z|or appropriate for you. This information is not individual||
4179|005|Z|medical advice and does not substitute for the advice of your||
4179|006|Z|health care professional. Always ask your health care||
4179|007|Z|professional for complete information about this product and your||
4179|008|Z|specific health needs.||
4179|009|B|||
4179|010|T|FLUCONAZOLE - INJECTION||
4179|011|F|(floo-KON-a-zole)||
4179|012|B|||
4179|013|C|COMMON BRAND NAME(S): Diflucan||
4179|014|B|||
4179|015|U|USES:  Fluconazole is an azole antifungal used to prevent and||
4179|016|U|treat a variety of fungal infections. It works by stopping the||
4179|017|U|growth of fungus.||
4179|018|B|||
4179|019|H|HOW TO USE:  This medication is given by injection into a vein as||
4179|020|H|directed by your doctor, usually once daily. The dosage is based||
4179|021|H|on your medical condition and response to treatment. Children's||
4179|022|H|dosage is also based on weight.||
4179|023|H|   If you are giving this medication to yourself at home, learn||
4179|024|H|all preparation and usage instructions from your health care||
4179|025|H|professional. Before using, check this product for particles or||
4179|026|H|discoloration. If either is present, do not use the liquid. Learn||
4179|027|H|how to store and discard medical supplies safely.||
4179|028|H|   This medication works best when the amount of medicine in your||
4179|029|H|body is kept at a constant level. Use this drug at evenly spaced||
4179|030|H|intervals.||
4179|031|H|   Continue to take this medication until the full prescribed||
4179|032|H|amount is finished, even if symptoms disappear. Stopping the||
4179|033|H|medication too early may result in a return of the infection.||
4179|034|H|   Tell your doctor if your condition lasts or gets worse.||
4179|035|B|||
4179|036|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach/abdominal||
4179|037|S|pain, hair loss, or headache may occur. If any of these effects||
4179|038|S|last or get worse, tell your doctor promptly.||
4179|039|S|   Remember that this medication has been prescribed because your||
4179|040|S|doctor has judged that the benefit to you is greater than the||
4179|041|S|risk of side effects. Many people using this medication do not||
4179|042|S|have serious side effects.||
4179|043|S|   Tell your doctor right away if you have any serious side||
4179|044|S|effects, including: easy bruising/bleeding, signs of your adrenal||
4179|045|S|glands not working well (such as loss of appetite, unusual||
4179|046|S|tiredness, weight loss).||
4179|047|S|   Get medical help right away if you have any very serious side||
4179|048|S|effects, including: severe dizziness, fainting, fast/irregular||
4179|049|S|heartbeat, seizures.||
4179|050|S|   This drug may rarely cause serious (possibly fatal) liver||
4179|051|S|disease. Get medical help right away if you develop any signs of||
4179|052|S|liver disease, including: nausea/vomiting that doesn't stop,||
4179|053|S|severe stomach/abdominal pain, yellowing eyes/skin, dark urine.||
4179|054|S|   A very serious allergic reaction to this drug is rare.||
4179|055|S|However, get medical help right away if you notice any symptoms||
4179|056|S|of a serious allergic reaction, including: fever that doesn't go||
4179|057|S|away, new or worsening lymph node swelling, rash,||
4179|058|S|itching/swelling (especially of the face/tongue/throat), severe||
4179|059|S|dizziness, trouble breathing.||
4179|060|S|   This is not a complete list of possible side effects. If you||
4179|061|S|notice other effects not listed above, contact your doctor or||
4179|062|S|pharmacist.||
4179|063|S|   In the US -||
4179|064|S|   Call your doctor for medical advice about side effects. You||
4179|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4179|066|S|www.fda.gov/medwatch.||
4179|067|S|   In Canada - Call your doctor for medical advice about side||
4179|068|S|effects. You may report side effects to Health Canada at||
4179|069|S|1-866-234-2345.||
4179|070|B|||
4179|071|P|PRECAUTIONS:  Before using fluconazole, tell your doctor or||
4179|072|P|pharmacist if you are allergic to it; or to other azole||
4179|073|P|antifungal drugs (such as itraconazole); or if you have any other||
4179|074|P|allergies. This product may contain inactive ingredients, which||
4179|075|P|can cause allergic reactions or other problems. Talk to your||
4179|076|P|pharmacist for more details.||
4179|077|P|   Before using this medication, tell your doctor or pharmacist||
4179|078|P|your medical history, especially of: liver disease, kidney||
4179|079|P|disease.||
4179|080|P|   Fluconazole may cause a condition that affects the heart||
4179|081|P|rhythm (QT prolongation). QT prolongation can rarely cause||
4179|082|P|serious (rarely fatal) fast/irregular heartbeat and other||
4179|083|P|symptoms (such as severe dizziness, fainting) that need medical||
4179|084|P|attention right away.||
4179|085|P|   The risk of QT prolongation may be increased if you have||
4179|086|P|certain medical conditions or are taking other drugs that may||
4179|087|P|cause QT prolongation. Before using fluconazole, tell your doctor||
4179|088|P|or pharmacist of all the drugs you take and if you have any of||
4179|089|P|the following conditions: certain heart problems (heart failure,||
4179|090|P|slow heartbeat, QT prolongation in the EKG), family history of||
4179|091|P|certain heart problems (QT prolongation in the EKG, sudden||
4179|092|P|cardiac death).||
4179|093|P|   Low levels of potassium or magnesium in the blood may also||
4179|094|P|increase your risk of QT prolongation. This risk may increase if||
4179|095|P|you use certain drugs (such as diuretics/"water pills") or if you||
4179|096|P|have conditions such as severe sweating, diarrhea, or vomiting.||
4179|097|P|Talk to your doctor about using fluconazole safely.||
4179|098|P|   Older adults may be more sensitive to the side effects of this||
4179|099|P|drug, especially QT prolongation (see above).||
4179|100|P|   Tell your doctor if you are pregnant or plan to become||
4179|101|P|pregnant. You should not become pregnant while using fluconazole.||
4179|102|P|Fluconazole may harm an unborn baby, especially during the first||
4179|103|P|3 months of pregnancy. Ask about reliable forms of birth control||
4179|104|P|while using this medication and for 1 week after the last dose.||
4179|105|P|If you become pregnant, talk to your doctor right away about the||
4179|106|P|risks and benefits of this medication.||
4179|107|P|   This drug passes into breast milk. Consult your doctor before||
4179|108|P|breastfeeding.||
4179|109|B|||
4179|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4179|111|I|medications work or increase your risk for serious side effects.||
4179|112|I|This document does not contain all possible drug interactions.||
4179|113|I|Keep a list of all the products you use (including||
4179|114|I|prescription/nonprescription drugs and herbal products) and share||
4179|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
4179|116|I|the dosage of any medicines without your doctor's approval.||
4179|117|I|   A product that may interact with this drug is: clopidogrel.||
4179|118|I|   Many drugs besides fluconazole may affect the heart rhythm (QT||
4179|119|I|prolongation), including pimozide, quinidine, macrolide||
4179|120|I|antibiotics (such as erythromycin), among others.||
4179|121|I|   Fluconazole can slow down the removal of other medications||
4179|122|I|from your body, which can affect how they work. Examples of||
4179|123|I|affected drugs include abrocitinib, deuruxolitinib, domperidone,||
4179|124|I|flibanserin, lemborexant, lomitapide, macitentan, mavacamten,||
4179|125|I|nirogacestat, rilzabrutinib, taletrectinib, among others.||
4179|126|B|||
4179|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4179|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4179|129|O|poison control center right away. US residents can call||
4179|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4179|131|O|Symptoms of overdose may include: hallucinations, mental/mood||
4179|132|O|changes.||
4179|133|B|||
4179|134|N|NOTES:  Lab and/or medical tests (such as liver function) should||
4179|135|N|be done while you are using this medication. Keep all medical and||
4179|136|N|lab appointments. Consult your doctor for more details.||
4179|137|B|||
4179|138|D|MISSED DOSE:  It is important to get each dose of this medication||
4179|139|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
4179|140|D|right away for a new dosing schedule. Do not double the dose to||
4179|141|D|catch up.||
4179|142|B|||
4179|143|R|STORAGE:  Consult the product instructions and your pharmacist||
4179|144|R|for storage details. Keep all medications away from children and||
4179|145|R|pets.||
4179|146|R|   Do not flush medications down the toilet or pour them into a||
4179|147|R|drain unless instructed to do so. Properly discard this product||
4179|148|R|when it is expired or no longer needed. Consult your pharmacist||
4179|149|R|or local waste disposal company.||
4179|150|B|||
4179|151|A|Information last revised September 2025.||
4179|152|A|Copyright(c) 2025 First Databank, Inc.||
4179|153|B|||
4186|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4186|002|Z|does NOT have all possible information about this product. This||
4186|003|Z|information does not assure that this product is safe, effective,||
4186|004|Z|or appropriate for you. This information is not individual||
4186|005|Z|medical advice and does not substitute for the advice of your||
4186|006|Z|health care professional. Always ask your health care||
4186|007|Z|professional for complete information about this product and your||
4186|008|Z|specific health needs.||
4186|009|B|||
4186|010|T|INDOMETHACIN - ORAL LIQUID||
4186|011|F|(in-doh-METH-uh-sin)||
4186|012|B|||
4186|013|C|COMMON BRAND NAME(S): Indocin||
4186|014|B|||
4186|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
4186|016|W|indomethacin) may rarely increase the risk for a heart attack or||
4186|017|W|stroke. This effect can happen at any time while taking this drug||
4186|018|W|but is more likely if you take it for a long time. The risk may||
4186|019|W|be greater in older adults or if you have heart disease or||
4186|020|W|increased risk for heart disease (for example, due to smoking,||
4186|021|W|family history of heart disease, or conditions such as high blood||
4186|022|W|pressure or diabetes). Do not take this drug right before or||
4186|023|W|after heart bypass surgery (CABG).||
4186|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
4186|025|W|bleeding from the stomach or intestines. This effect can occur||
4186|026|W|without warning symptoms at any time while taking this drug.||
4186|027|W|Older adults may be at higher risk for this effect. (See also||
4186|028|W|Precautions and Drug Interactions sections.)||
4186|029|W|   Stop taking indomethacin and get medical help right away if||
4186|030|W|you notice any of the following rare but serious side effects:||
4186|031|W|stomach/abdominal pain that doesn't go away, bloody or||
4186|032|W|black/tarry stools, vomit that looks like coffee grounds,||
4186|033|W|chest/jaw/left arm pain, shortness of breath, unusual sweating,||
4186|034|W|weakness on one side of the body, sudden vision changes, trouble||
4186|035|W|speaking.||
4186|036|W|   Talk with your doctor or pharmacist about the risks and||
4186|037|W|benefits of treatment with this medication.||
4186|038|B|||
4186|039|U|USES:  Indomethacin is used to relieve pain, swelling, and joint||
4186|040|U|stiffness caused by arthritis, gout, bursitis, and tendonitis.||
4186|041|U|Reducing these symptoms helps you do more of your normal daily||
4186|042|U|activities. This medication is known as a nonsteroidal||
4186|043|U|anti-inflammatory drug (NSAID).||
4186|044|U|   If you are treating a chronic condition such as arthritis, ask||
4186|045|U|your doctor about non-drug treatments and/or using other||
4186|046|U|medications to treat your pain. See also Warning section.||
4186|047|B|||
4186|048|V|OTHER USES:  This section contains uses of this drug that are not||
4186|049|V|listed in the approved professional labeling for the drug but||
4186|050|V|that may be prescribed by your health care professional. Use this||
4186|051|V|drug for a condition that is listed in this section only if it||
4186|052|V|has been so prescribed by your health care professional.||
4186|053|V|   This medication may also be used to relieve pain caused by||
4186|054|V|inflammation of the pouch surrounding the heart and other||
4186|055|V|conditions, as prescribed by your doctor.||
4186|056|B|||
4186|057|H|HOW TO USE:  Read the Medication Guide provided by your||
4186|058|H|pharmacist before you start using indomethacin and each time you||
4186|059|H|get a refill. If you have any questions, ask your doctor or||
4186|060|H|pharmacist.||
4186|061|H|   Shake the bottle well before each dose. Measure the dose out||
4186|062|H|carefully with a medication spoon/cup. Take this medication||
4186|063|H|either with food, right after meals, or with antacids to prevent||
4186|064|H|stomach upset.||
4186|065|H|   The dosage is based on your medical condition and response to||
4186|066|H|treatment. Children's dosage is also based on weight. To lessen||
4186|067|H|side effect risks (such as stomach bleeding), use this medication||
4186|068|H|at the lowest effective dose for the shortest possible length of||
4186|069|H|time. Do not increase your dose or take it more often than||
4186|070|H|prescribed. For chronic conditions such as arthritis, keep taking||
4186|071|H|it as directed by your doctor. Discuss the risks and benefits||
4186|072|H|with your doctor or pharmacist.||
4186|073|H|   In certain conditions (such as arthritis), it may take up to 4||
4186|074|H|weeks when this drug is taken regularly before you notice the||
4186|075|H|full benefits.||
4186|076|H|   If you are taking this drug on an "as needed" basis (not on a||
4186|077|H|regular schedule), remember that pain medications work best if||
4186|078|H|they are used as the first signs of pain occur. If you wait until||
4186|079|H|the pain has worsened, the medication may not work as well.||
4186|080|H|   Tell your doctor if your condition gets worse.||
4186|081|B|||
4186|082|S|SIDE EFFECTS:  See also Warning section.||
4186|083|S|   Upset stomach, heartburn, headache, drowsiness, or dizziness||
4186|084|S|may occur. If any of these effects last or get worse, tell your||
4186|085|S|doctor or pharmacist promptly.||
4186|086|S|   Remember that this medication has been prescribed because your||
4186|087|S|doctor has judged that the benefit to you is greater than the||
4186|088|S|risk of side effects. Many people using this medication do not||
4186|089|S|have serious side effects.||
4186|090|S|   This medication may raise your blood pressure. Check your||
4186|091|S|blood pressure regularly and tell your doctor if the results are||
4186|092|S|high.||
4186|093|S|   Tell your doctor right away if you have any serious side||
4186|094|S|effects, including: hearing changes (such as ringing in the||
4186|095|S|ears), mental/mood changes (such as confusion, hallucinations),||
4186|096|S|difficult/painful swallowing, signs of kidney problems (such as||
4186|097|S|change in the amount of urine), symptoms of heart failure (such||
4186|098|S|as swelling ankles/feet, unusual tiredness, unusual/sudden weight||
4186|099|S|gain).||
4186|100|S|   This drug may rarely cause serious (possibly fatal) liver||
4186|101|S|disease. Get medical help right away if you have any symptoms of||
4186|102|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
4186|103|S|of appetite, dark urine, severe stomach/abdominal pain, yellowing||
4186|104|S|eyes/skin.||
4186|105|S|   A very serious allergic reaction to this drug is rare.||
4186|106|S|However, get medical help right away if you notice any symptoms||
4186|107|S|of a serious allergic reaction, including: fever, swollen lymph||
4186|108|S|nodes, rash, itching/swelling (especially of the||
4186|109|S|face/tongue/throat), severe dizziness, trouble breathing.||
4186|110|S|   This is not a complete list of possible side effects. If you||
4186|111|S|notice other effects not listed above, contact your doctor or||
4186|112|S|pharmacist.||
4186|113|S|   In the US -||
4186|114|S|   Call your doctor for medical advice about side effects. You||
4186|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4186|116|S|www.fda.gov/medwatch.||
4186|117|S|   In Canada - Call your doctor for medical advice about side||
4186|118|S|effects. You may report side effects to Health Canada at||
4186|119|S|1-866-234-2345.||
4186|120|B|||
4186|121|P|PRECAUTIONS:  Before taking indomethacin, tell your doctor or||
4186|122|P|pharmacist if you are allergic to it; or to aspirin or other||
4186|123|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
4186|124|P|any other allergies. This product may contain inactive||
4186|125|P|ingredients, which can cause allergic reactions or other||
4186|126|P|problems. Talk to your pharmacist for more details.||
4186|127|P|   Before using this medication, tell your doctor or pharmacist||
4186|128|P|your medical history, especially of: asthma (including a history||
4186|129|P|of worsening breathing after taking aspirin or other NSAIDs),||
4186|130|P|bleeding or clotting problems, growths in the nose (nasal||
4186|131|P|polyps), heart disease (such as previous heart attack), high||
4186|132|P|blood pressure, liver disease, stomach/intestinal/esophagus||
4186|133|P|problems (such as bleeding, ulcers, recurring heartburn), stroke.||
4186|134|P|   Kidney problems can sometimes occur with the use of NSAID||
4186|135|P|medications, including indomethacin. Problems are more likely to||
4186|136|P|occur if you are dehydrated, have heart failure or kidney||
4186|137|P|disease, are an older adult, or if you take certain medications||
4186|138|P|(see also Drug Interactions section). Drink plenty of fluids as||
4186|139|P|directed by your doctor to prevent dehydration and tell your||
4186|140|P|doctor right away if you have a change in the amount of urine.||
4186|141|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4186|142|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4186|143|P|machinery, or do anything that needs alertness until you can do||
4186|144|P|it safely. Talk to your doctor if you are using marijuana||
4186|145|P|(cannabis).||
4186|146|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
4186|147|P|and tobacco, especially when combined with this medicine, may||
4186|148|P|increase your risk for stomach bleeding. Limit alcohol and stop||
4186|149|P|smoking. Consult your doctor or pharmacist for more information.||
4186|150|P|   Before having surgery, tell your doctor or dentist about all||
4186|151|P|the products you use (including prescription drugs,||
4186|152|P|nonprescription drugs, and herbal products).||
4186|153|P|   This medication may make you more sensitive to the sun. Limit||
4186|154|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4186|155|P|sunscreen and wear protective clothing when outdoors. Tell your||
4186|156|P|doctor right away if you get sunburned or have skin||
4186|157|P|blisters/redness.||
4186|158|P|   Older adults may be at greater risk for stomach/intestinal||
4186|159|P|bleeding, kidney problems, heart attack, stroke, and mental/mood||
4186|160|P|changes while using this drug.||
4186|161|P|   Children may be more sensitive to the side effects of this||
4186|162|P|drug, especially serious liver problems. Caution is advised when||
4186|163|P|this drug is used by children. Discuss the risks and benefits of||
4186|164|P|treatment with your doctor.||
4186|165|P|   Before using this medication, women of childbearing age should||
4186|166|P|talk with their doctor(s) about the benefits and risks. Tell your||
4186|167|P|doctor if you are pregnant or if you plan to become pregnant.||
4186|168|P|This medication may harm an unborn baby and cause problems with||
4186|169|P|normal labor/delivery. It is not recommended for use in pregnancy||
4186|170|P|from 20 weeks until delivery. If your doctor decides that you||
4186|171|P|need to use this medication between 20 and 30 weeks of pregnancy,||
4186|172|P|you should use the lowest effective dose for the shortest||
4186|173|P|possible time. You should not use this medication after 30 weeks||
4186|174|P|of pregnancy.||
4186|175|P|   This drug passes into breast milk and may have undesirable||
4186|176|P|effects on a nursing infant. Consult your doctor before||
4186|177|P|breastfeeding.||
4186|178|B|||
4186|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4186|180|I|medications work or increase your risk for serious side effects.||
4186|181|I|This document does not contain all possible drug interactions.||
4186|182|I|Keep a list of all the products you use (including||
4186|183|I|prescription/nonprescription drugs and herbal products) and share||
4186|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
4186|185|I|the dosage of any medicines without your doctor's approval.||
4186|186|I|   Some products that may interact with this drug include:||
4186|187|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
4186|188|I|angiotensin II receptor blockers (such as valsartan, losartan),||
4186|189|I|cidofovir, corticosteroids (such as prednisone), lithium,||
4186|190|I|methotrexate, "water pills" (diuretics such as furosemide).||
4186|191|I|   This medication may increase the risk of bleeding when taken||
4186|192|I|with other drugs that also may cause bleeding. Examples include||
4186|193|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
4186|194|I|dabigatran/enoxaparin/warfarin, among others.||
4186|195|I|   Check all prescription and nonprescription medicine labels||
4186|196|I|carefully since many medications contain pain relievers/fever||
4186|197|I|reducers (aspirin, NSAIDs such as celecoxib, diflunisal,||
4186|198|I|ibuprofen, or ketorolac). These drugs are similar to indomethacin||
4186|199|I|and may increase your risk of side effects if taken together.||
4186|200|I|However, if your doctor has told you to take low-dose aspirin to||
4186|201|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
4186|202|I|you should keep taking the aspirin unless your doctor tells you||
4186|203|I|not to. Ask your doctor or pharmacist for more details.||
4186|204|I|   This medication may interfere with certain lab tests, possibly||
4186|205|I|causing false test results. Make sure lab personnel and all your||
4186|206|I|doctors know you use this drug.||
4186|207|B|||
4186|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4186|209|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4186|210|O|poison control center right away. US residents can call||
4186|211|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4186|212|O|Symptoms of overdose may include: severe stomach pain, vomit that||
4186|213|O|looks like coffee grounds, extreme drowsiness, slow or shallow||
4186|214|O|breathing, confusion, seizures.||
4186|215|B|||
4186|216|N|NOTES:  Do not share this medication with others.||
4186|217|N|   Lab and/or medical tests (such as blood pressure, complete||
4186|218|N|blood count, liver/kidney function) may be done while you are||
4186|219|N|taking this medication. Keep all medical and lab appointments.||
4186|220|N|Consult your doctor for more details.||
4186|221|N|   Non-drug treatment for arthritis that is approved by your||
4186|222|N|doctor (such as weight loss if needed, strengthening and||
4186|223|N|conditioning exercises) may help improve your flexibility, range||
4186|224|N|of motion, and joint function. Consult your doctor for specific||
4186|225|N|instructions.||
4186|226|B|||
4186|227|D|MISSED DOSE:  If you are prescribed this drug on a regular||
4186|228|D|schedule (not just "as needed") and you miss a dose, take it as||
4186|229|D|soon as you remember. If it is near the time of the next dose,||
4186|230|D|skip the missed dose. Take your next dose at the regular time. Do||
4186|231|D|not double the dose to catch up.||
4186|232|B|||
4186|233|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
4186|234|R|medications away from children and pets.||
4186|235|R|   Do not flush medications down the toilet or pour them into a||
4186|236|R|drain unless instructed to do so. Properly discard this product||
4186|237|R|when it is expired or no longer needed. Consult your pharmacist||
4186|238|R|or local waste disposal company.||
4186|239|B|||
4186|240|A|Information last revised May 2025.||
4186|241|A|Copyright(c) 2025 First Databank, Inc.||
4186|242|B|||
4187|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4187|002|Z|does NOT have all possible information about this product. This||
4187|003|Z|information does not assure that this product is safe, effective,||
4187|004|Z|or appropriate for you. This information is not individual||
4187|005|Z|medical advice and does not substitute for the advice of your||
4187|006|Z|health care professional. Always ask your health care||
4187|007|Z|professional for complete information about this product and your||
4187|008|Z|specific health needs.||
4187|009|B|||
4187|010|T|DEXRAZOXANE - INJECTION||
4187|011|F|(DEX-ra-ZOX-ane)||
4187|012|B|||
4187|013|C|COMMON BRAND NAME(S): Zinecard||
4187|014|B|||
4187|015|U|USES:  Dexrazoxane is used to reduce the risk and severity of||
4187|016|U|heart damage caused by doxorubicin treatment and similar cancer||
4187|017|U|chemotherapy medications. Heart damage limits the length of time||
4187|018|U|you can be treated with doxorubicin. Dexrazoxane allows you to||
4187|019|U|continue doxorubicin treatment for longer. When used for this||
4187|020|U|purpose, dexrazoxane treatment is usually started after you have||
4187|021|U|received several doses of doxorubicin. It is usually not given||
4187|022|U|with the first doses of doxorubicin since doing so may reduce the||
4187|023|U|effectiveness of doxorubicin.||
4187|024|B|||
4187|025|V|OTHER USES:  This section contains uses of this drug that are not||
4187|026|V|listed in the approved professional labeling for the drug but||
4187|027|V|that may be prescribed by your health care professional. Use this||
4187|028|V|drug for a condition that is listed in this section only if it||
4187|029|V|has been so prescribed by your health care professional.||
4187|030|V|   Dexrazoxane is also available in another brand that is used to||
4187|031|V|reduce serious tissue injury if doxorubicin or a related||
4187|032|V|chemotherapy drug has leaked out of the vein into the surrounding||
4187|033|V|tissue.||
4187|034|B|||
4187|035|H|HOW TO USE:  This medication is given by injection into a vein by||
4187|036|H|a health care professional. It is given as directed by your||
4187|037|H|doctor, usually over 15 minutes.||
4187|038|H|   The dosage is based on your medical condition and response to||
4187|039|H|treatment.||
4187|040|B|||
4187|041|S|SIDE EFFECTS:  Pain at the injection site may occur. If this||
4187|042|S|effect lasts or gets worse, tell your doctor or pharmacist||
4187|043|S|promptly.||
4187|044|S|   Remember that this medication has been prescribed because your||
4187|045|S|doctor has judged that the benefit to you is greater than the||
4187|046|S|risk of side effects. Many people using this medication do not||
4187|047|S|have serious side effects.||
4187|048|S|   Tell your doctor right away if you have any serious side||
4187|049|S|effects, including: signs of infection (such as sore throat that||
4187|050|S|doesn't go away, fever, chills), easy bruising/bleeding.||
4187|051|S|   Very rarely, people with cancer who have been treated with||
4187|052|S|this medication have developed other cancers (such as leukemia,||
4187|053|S|lymphoma). Consult your doctor for more details.||
4187|054|S|   A very serious allergic reaction to this drug is rare.||
4187|055|S|However, get medical help right away if you notice any symptoms||
4187|056|S|of a serious allergic reaction, including: rash, itching/swelling||
4187|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4187|058|S|breathing.||
4187|059|S|   This is not a complete list of possible side effects. If you||
4187|060|S|notice other effects not listed above, contact your doctor or||
4187|061|S|pharmacist.||
4187|062|S|   In the US -||
4187|063|S|   Call your doctor for medical advice about side effects. You||
4187|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4187|065|S|www.fda.gov/medwatch.||
4187|066|S|   In Canada - Call your doctor for medical advice about side||
4187|067|S|effects. You may report side effects to Health Canada at||
4187|068|S|1-866-234-2345.||
4187|069|B|||
4187|070|P|PRECAUTIONS:  Before using dexrazoxane, tell your doctor or||
4187|071|P|pharmacist if you are allergic to it; or if you have any other||
4187|072|P|allergies. This product may contain inactive ingredients, which||
4187|073|P|can cause allergic reactions or other problems. Talk to your||
4187|074|P|pharmacist for more details.||
4187|075|P|   Before using this medication, tell your doctor or pharmacist||
4187|076|P|your medical history, especially of: kidney disease, liver||
4187|077|P|disease.||
4187|078|P|   Before having surgery, tell your doctor or dentist about all||
4187|079|P|the products you use (including prescription drugs,||
4187|080|P|nonprescription drugs, and herbal products).||
4187|081|P|   Tell your doctor if you are pregnant or plan to become||
4187|082|P|pregnant. You should not become pregnant while using dexrazoxane.||
4187|083|P|Dexrazoxane may harm an unborn baby. Your doctor should order a||
4187|084|P|pregnancy test before you start this medication. Women using this||
4187|085|P|medication should ask about reliable forms of birth control||
4187|086|P|during treatment and for at least 6 months after the last dose.||
4187|087|P|Men using this medication should ask about reliable forms of||
4187|088|P|birth control during treatment and for at least 3 months after||
4187|089|P|the last dose. If you or your partner becomes pregnant, talk to||
4187|090|P|your doctor right away about the risks and benefits of this||
4187|091|P|medication.||
4187|092|P|   It is unknown if this drug passes into breast milk. Because of||
4187|093|P|the possible risk to the infant, breastfeeding is not recommended||
4187|094|P|while using this drug and for 2 weeks after the last dose.||
4187|095|P|Consult your doctor before breastfeeding.||
4187|096|B|||
4187|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4187|098|I|medications work or increase your risk for serious side effects.||
4187|099|I|This document does not contain all possible drug interactions.||
4187|100|I|Keep a list of all the products you use (including||
4187|101|I|prescription/nonprescription drugs and herbal products) and share||
4187|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
4187|103|I|the dosage of any medicines without your doctor's approval.||
4187|104|B|||
4187|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4187|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4187|107|O|poison control center right away. US residents can call||
4187|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4187|109|B|||
4187|110|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
4187|111|N|heart function) should be done while you are using this||
4187|112|N|medication. Keep all medical and lab appointments. Consult your||
4187|113|N|doctor for more details.||
4187|114|B|||
4187|115|D|MISSED DOSE:  It is important to get each dose of this medication||
4187|116|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
4187|117|D|right away for a new dosing schedule.||
4187|118|B|||
4187|119|R|STORAGE:  Not applicable. This medication is given in a clinic||
4187|120|R|and will not be stored at home.||
4187|121|B|||
4187|122|A|Information last revised June 2025.||
4187|123|A|Copyright(c) 2025 First Databank, Inc.||
4187|124|B|||
4196|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4196|002|Z|does NOT have all possible information about this product. This||
4196|003|Z|information does not assure that this product is safe, effective,||
4196|004|Z|or appropriate for you. This information is not individual||
4196|005|Z|medical advice and does not substitute for the advice of your||
4196|006|Z|health care professional. Always ask your health care||
4196|007|Z|professional for complete information about this product and your||
4196|008|Z|specific health needs.||
4196|009|B|||
4196|010|T|NEOMYCIN/COLISTIN/HYDROCORTISONE/THONZONIUM SUSPENSION - OTIC||
4196|011|F|(nee-oh-MY-sin/koh-LIH-stin/hi-dro-KOR-tih-sown/thon-ZHO-nee-um)||
4196|012|B|||
4196|013|C|COMMON BRAND NAME(S): Cortisporin-TC||
4196|014|B|||
4196|015|U|USES:  This ear drop is used to treat outer ear infections caused||
4196|016|U|by bacteria (also known as swimmer's ear). This product contains||
4196|017|U|neomycin and colistin, which are antibiotics that work by||
4196|018|U|stopping the growth of bacteria. It also contains hydrocortisone,||
4196|019|U|which is an anti-inflammatory corticosteroid that works by||
4196|020|U|reducing ear swelling and discomfort, and thonzonium, which helps||
4196|021|U|this medication pass through dead cells and pus inside the ear.||
4196|022|U|   This medication treats only bacterial ear infections. It will||
4196|023|U|not work for other types of ear infections. Unnecessary use or||
4196|024|U|overuse of any antibiotic can lead to its decreased||
4196|025|U|effectiveness.||
4196|026|B|||
4196|027|H|HOW TO USE:  Use this medication in the infected ear as directed||
4196|028|H|by your doctor, usually 3 or 4 times a day. The ear canal should||
4196|029|H|be clean and dry before using this medication. Use in the ear||
4196|030|H|only. Do not use in the eyes.||
4196|031|H|   To make sure that the right amount of medication is given, and||
4196|032|H|to avoid touching the ear with the dropper, have another person||
4196|033|H|give the drops if possible. To lower the risk of dizziness, hold||
4196|034|H|the container in your hand for a few minutes in order to warm it.||
4196|035|H|   To apply ear drops, wash your hands first. To avoid||
4196|036|H|contamination, do not touch the dropper tip or let it touch your||
4196|037|H|ear or any other surface. Shake the container well before using.||
4196|038|H|   Lie on your side with the treated ear upward. Hold the dropper||
4196|039|H|directly over the ear and place the prescribed number of drops||
4196|040|H|into the ear canal. To help the drops roll into the ear of an||
4196|041|H|adult, hold the earlobe up and back. For children, hold the||
4196|042|H|earlobe down and back. Keep the head tilted with the treated ear||
4196|043|H|upward for 5 minutes or insert a soft cotton plug if so directed.||
4196|044|H|Another way to give this medication is to place a cotton wick in||
4196|045|H|the ear canal and moisten it with the prescribed number of drops||
4196|046|H|as often as directed. The wick should be replaced at least once a||
4196|047|H|day.||
4196|048|H|   Repeat the above steps for the other ear if so directed. Do||
4196|049|H|not rinse the dropper. Replace the cap after use.||
4196|050|H|   Use this medication regularly in order to get the most benefit||
4196|051|H|from it. To help you remember, use it at the same times each day.||
4196|052|H|Continue to use this medication for the full time prescribed,||
4196|053|H|even if symptoms disappear after a few days. Stopping the||
4196|054|H|medication too early may result in a return of the infection.||
4196|055|H|   Do not use this medication more often than prescribed or||
4196|056|H|continue to use it for longer than 10 days.||
4196|057|H|   Tell your doctor if your condition lasts or gets worse.||
4196|058|B|||
4196|059|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
4196|060|S|ear for a minute or two when applied. If these effects last or||
4196|061|S|get worse, tell your doctor or pharmacist promptly.||
4196|062|S|   Remember that this medication has been prescribed because your||
4196|063|S|doctor has judged that the benefit to you is greater than the||
4196|064|S|risk of side effects. Many people using this medication do not||
4196|065|S|have serious side effects.||
4196|066|S|   Tell your doctor right away if you have any serious side||
4196|067|S|effects, including: hearing problems (such as hearing loss).||
4196|068|S|   Use of this medication for prolonged or repeated periods may||
4196|069|S|result in a new fungal ear infection. Do not use it for longer||
4196|070|S|than prescribed. Contact your doctor if you notice new or||
4196|071|S|worsening symptoms.||
4196|072|S|   A very serious allergic reaction to this drug is rare.||
4196|073|S|However, get medical help right away if you notice any symptoms||
4196|074|S|of a serious allergic reaction, including: rash, itching/swelling||
4196|075|S|(especially of the face/tongue/throat), redness of the ears,||
4196|076|S|severe dizziness, trouble breathing.||
4196|077|S|   This is not a complete list of possible side effects. If you||
4196|078|S|notice other effects not listed above, contact your doctor or||
4196|079|S|pharmacist.||
4196|080|S|   In the US -||
4196|081|S|   Call your doctor for medical advice about side effects. You||
4196|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4196|083|S|www.fda.gov/medwatch.||
4196|084|S|   In Canada - Call your doctor for medical advice about side||
4196|085|S|effects. You may report side effects to Health Canada at||
4196|086|S|1-866-234-2345.||
4196|087|B|||
4196|088|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
4196|089|P|pharmacist if you are allergic to neomycin, colistin,||
4196|090|P|hydrocortisone, or thonzonium; or to aminoglycoside antibiotics||
4196|091|P|(such as gentamicin, tobramycin); or to corticosteroids (such as||
4196|092|P|dexamethasone, prednisone); or if you have any other allergies.||
4196|093|P|This product may contain inactive ingredients (such as||
4196|094|P|preservatives like thimerosal), which can cause allergic||
4196|095|P|reactions or other problems. Talk to your pharmacist for more||
4196|096|P|details.||
4196|097|P|   Before using this medication, tell your doctor or pharmacist||
4196|098|P|your medical history, especially of: other ear problems (such as||
4196|099|P|a hole in your eardrum, middle ear infection), an ear infection||
4196|100|P|caused by a virus (such as herpes simplex, varicella).||
4196|101|P|   This medication should be used only if clearly needed during||
4196|102|P|pregnancy. Discuss the risks and benefits with your doctor.||
4196|103|P|   It is unknown if this medication passes into breast milk.||
4196|104|P|Consult your doctor before breastfeeding.||
4196|105|B|||
4196|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4196|107|I|medications work or increase your risk for serious side effects.||
4196|108|I|This document does not contain all possible drug interactions.||
4196|109|I|Keep a list of all the products you use (including||
4196|110|I|prescription/nonprescription drugs and herbal products) and share||
4196|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
4196|112|I|the dosage of any medicines without your doctor's approval.||
4196|113|B|||
4196|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4196|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4196|116|O|poison control center right away. US residents can call||
4196|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
4196|118|O|medicine may be harmful if swallowed.||
4196|119|B|||
4196|120|N|NOTES:  Do not share this medication with others.||
4196|121|N|   This medication has been prescribed for your current condition||
4196|122|N|only. Do not use it later for another infection unless your||
4196|123|N|doctor tells you to.||
4196|124|N|   It is important to keep the infected ear(s) clean and dry. Try||
4196|125|N|not to get the infected ear(s) wet when bathing. Avoid swimming||
4196|126|N|unless your doctor tells you otherwise.||
4196|127|B|||
4196|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4196|129|D|If it is near the time of the next dose, skip the missed dose.||
4196|130|D|Use your next dose at the regular time. Do not double the dose to||
4196|131|D|catch up.||
4196|132|B|||
4196|133|R|STORAGE:  Store at room temperature away from heat and light.||
4196|134|R|Keep all medications away from children and pets.||
4196|135|R|   Do not flush medications down the toilet or pour them into a||
4196|136|R|drain unless instructed to do so. Properly discard this product||
4196|137|R|when it is expired or no longer needed. Consult your pharmacist||
4196|138|R|or local waste disposal company.||
4196|139|B|||
4196|140|A|Information last revised May 2024.||
4196|141|A|Copyright(c) 2025 First Databank, Inc.||
4196|142|B|||
4198|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4198|002|Z|does NOT have all possible information about this product. This||
4198|003|Z|information does not assure that this product is safe, effective,||
4198|004|Z|or appropriate for you. This information is not individual||
4198|005|Z|medical advice and does not substitute for the advice of your||
4198|006|Z|health care professional. Always ask your health care||
4198|007|Z|professional for complete information about this product and your||
4198|008|Z|specific health needs.||
4198|009|B|||
4198|010|T|FLUOCINOLONE/TRETINOIN/HYDROQUINONE - TOPICAL||
4198|011|F|(FLOO-oh-SIN-oh-lone/tret-ih-NO-in/hi-dro-KWIN-own)||
4198|012|B|||
4198|013|C|COMMON BRAND NAME(S): Tri-Luma||
4198|014|B|||
4198|015|U|USES:  This combination medication is used to treat melasma on||
4198|016|U|the face. Melasma is a condition of dark patchy areas on the||
4198|017|U|skin, especially on the cheeks and forehead. It sometimes occurs||
4198|018|U|with hormone changes. This product contains 3 different kinds of||
4198|019|U|medication. Hydroquinone is a reversible skin bleaching agent.||
4198|020|U|Tretinoin is a retinoid that increases skin shedding.||
4198|021|U|Fluocinolone is a medium strength corticosteroid that reduces||
4198|022|U|swelling, itching, and redness.||
4198|023|U|   This medication may improve your melasma, but it is not a||
4198|024|U|cure. Continued exposure to some of the causes of melasma (such||
4198|025|U|as sunlight, estrogen-type birth control hormones) may cause it||
4198|026|U|to return.||
4198|027|B|||
4198|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4198|029|H|from your pharmacist before you start using this product and each||
4198|030|H|time you get a refill. If you have any questions, ask your doctor||
4198|031|H|or pharmacist.||
4198|032|H|   Before using, apply a small amount of this medicine to an area||
4198|033|H|of unbroken skin, and check the area within 24 hours for any||
4198|034|H|serious side effects. If the test area is itching, red, puffy, or||
4198|035|H|blistering, do not use this product and contact your doctor. If||
4198|036|H|there is just mild redness, then treatment with this product may||
4198|037|H|begin.||
4198|038|H|   Before using, gently wash your face and neck with a mild||
4198|039|H|soapless cleanser. Rinse and pat dry the skin.||
4198|040|H|   Apply a thin layer of medication to the affected area,||
4198|041|H|including about 1/2 inch (1.5 centimeters) of normal-appearing||
4198|042|H|skin around the affected area as directed by your doctor, usually||
4198|043|H|once daily 30 minutes before bedtime. Rub the medication into the||
4198|044|H|skin gently and completely. Do not bandage, cover, or wrap the||
4198|045|H|area unless directed to do so by your doctor.||
4198|046|H|   This medication may make the treated areas of skin more||
4198|047|H|sensitive to the sun. Avoid prolonged sun exposure, tanning||
4198|048|H|booths, and sunlamps. Use a sunscreen of SPF 30 or greater and||
4198|049|H|wear protective clothing on the treated areas of skin when||
4198|050|H|outdoors, even on cloudy or hazy days.||
4198|051|H|   If you experience dry skin from using this product, you may||
4198|052|H|use a skin moisturizer in the morning after washing your face.||
4198|053|H|You may also use a moisturizer and cosmetics during the day while||
4198|054|H|using this medication.||
4198|055|H|   Avoid getting this product in your eyes or on the inside of||
4198|056|H|your nose or mouth. If you do get this medication in those areas,||
4198|057|H|flush with plenty of water. If severe irritation occurs, seek||
4198|058|H|medical attention promptly.||
4198|059|H|   Use this medication regularly to get the most benefit from it.||
4198|060|H|To help you remember, use it at the same time each night.||
4198|061|H|   It may take up to 4 weeks to notice significant improvement.||
4198|062|H|However, this medication is not recommended for long-term use||
4198|063|H|(such as longer than 8 weeks) without stopping the medication for||
4198|064|H|short periods. Tell your doctor if your condition lasts or gets||
4198|065|H|worse after 4 weeks of treatment.||
4198|066|B|||
4198|067|S|SIDE EFFECTS:  See also How to Use.||
4198|068|S|   Mild burning, stinging, redness, dryness, or acne may occur.||
4198|069|S|If any of these effects last or get worse, tell your doctor or||
4198|070|S|pharmacist promptly.||
4198|071|S|   Remember that this medication has been prescribed because your||
4198|072|S|doctor has judged that the benefit to you is greater than the||
4198|073|S|risk of side effects. Many people using this medication do not||
4198|074|S|have serious side effects.||
4198|075|S|   Tell your doctor right away if you have any serious side||
4198|076|S|effects, including: blistering, skin cracking/shedding, "spider||
4198|077|S|veins" (telangiectasia), stretch marks, other skin discoloration||
4198|078|S|(besides melasma), small red bumps on the skin (folliculitis),||
4198|079|S|blue-black darkening of the skin, numbness/tingling of||
4198|080|S|hands/feet, increased pain/touch sensitivity.||
4198|081|S|   Rarely, it is possible this medication will be absorbed from||
4198|082|S|the skin into the bloodstream. This can lead to side effects of||
4198|083|S|too much corticosteroid. These side effects are more likely in||
4198|084|S|children and people who use this medication for a long time or||
4198|085|S|over large areas of the skin. Tell your doctor right away if any||
4198|086|S|of the following side effects occur: unusual/extreme tiredness,||
4198|087|S|weight loss, headache, swelling ankles/feet, increased||
4198|088|S|thirst/urination, vision problems.||
4198|089|S|   A very serious allergic reaction to this drug is rare.||
4198|090|S|However, get medical help right away if you notice any symptoms||
4198|091|S|of a serious allergic reaction, including: rash, itching/swelling||
4198|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4198|093|S|breathing.||
4198|094|S|   This is not a complete list of possible side effects. If you||
4198|095|S|notice any other effects not listed above, contact your doctor or||
4198|096|S|pharmacist.||
4198|097|S|   In the US -||
4198|098|S|   Call your doctor for medical advice about side effects. You||
4198|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4198|100|S|www.fda.gov/medwatch.||
4198|101|S|   In Canada - Call your doctor for medical advice about side||
4198|102|S|effects. You may report side effects to Health Canada at||
4198|103|S|1-866-234-2345.||
4198|104|B|||
4198|105|P|PRECAUTIONS:  Before using fluocinolone/tretinoin/hydroquinone,||
4198|106|P|tell your doctor or pharmacist if you are allergic to it; or to||
4198|107|P|other corticosteroids (such as hydrocortisone, prednisone); or to||
4198|108|P|vitamin A-related drugs (other retinoids such as isotretinoin);||
4198|109|P|or if you have any other allergies. This product may contain||
4198|110|P|inactive ingredients (such as sulfites), which can cause allergic||
4198|111|P|reactions or other problems. Talk to your pharmacist for more||
4198|112|P|details.||
4198|113|P|   Before using this medication, tell your doctor or pharmacist||
4198|114|P|your medical history, especially of: asthma, open sores or broken||
4198|115|P|areas of skin (especially on the face or hands), other skin||
4198|116|P|conditions (such as eczema, psoriasis).||
4198|117|P|   Too much bleaching of the skin might occur in some cases,||
4198|118|P|resulting in an undesirable cosmetic effect in those with darker||
4198|119|P|skin. Consult your doctor or pharmacist for more details.||
4198|120|P|   Rarely, using corticosteroid medications for a long time can||
4198|121|P|make it more difficult for your body to respond to physical||
4198|122|P|stress. Before having surgery or emergency treatment, or if you||
4198|123|P|get a serious illness/injury, tell your doctor or dentist that||
4198|124|P|you are using this medication or have used this medication within||
4198|125|P|the past few months.||
4198|126|P|   Though it is unlikely, this medication may temporarily slow||
4198|127|P|down a child's growth if used for a long time. See the doctor||
4198|128|P|regularly so your child's height can be checked.||
4198|129|P|   During pregnancy, this medication should be used only when||
4198|130|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
4198|131|P|benefits with your doctor.||
4198|132|P|   It is unknown if these drugs pass into breast milk when||
4198|133|P|applied to the skin. Consult your doctor before breastfeeding.||
4198|134|B|||
4198|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4198|136|I|medications work or increase your risk for serious side effects.||
4198|137|I|This document does not contain all possible drug interactions.||
4198|138|I|Keep a list of all the products you use (including||
4198|139|I|prescription/nonprescription drugs and herbal products) and share||
4198|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
4198|141|I|the dosage of any medicines without your doctor's approval.||
4198|142|I|   Some products that may interact with this drug are: other||
4198|143|I|medicated skin products (such as soaps, cleansers, skin||
4198|144|I|medications, skin-drying cosmetics), hormone-based birth control||
4198|145|I|products (such as birth control pills, hormone implants).||
4198|146|B|||
4198|147|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
4198|148|O|has overdosed and has serious symptoms such as passing out or||
4198|149|O|trouble breathing, call 911. Otherwise, call a poison control||
4198|150|O|center right away. US residents can call 1-800-222-1222. Canada||
4198|151|O|residents can call 1-844-764-7669.||
4198|152|B|||
4198|153|N|NOTES:  Do not share this medication with others.||
4198|154|N|   This medication has been prescribed for your current condition||
4198|155|N|only. Do not use it later for another skin problem unless told to||
4198|156|N|do so by your doctor. A different medication may be necessary in||
4198|157|N|that case.||
4198|158|N|   Lab and/or medical tests (such as adrenal gland function) may||
4198|159|N|be done while you are using this medication, especially if you||
4198|160|N|use this drug for an extended period of time or apply it over||
4198|161|N|large areas of the body. Keep all medical and lab appointments.||
4198|162|N|Consult your doctor for more details.||
4198|163|B|||
4198|164|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4198|165|D|If it is near the time of the next dose, skip the missed dose.||
4198|166|D|Use your next dose at the regular time. Do not double the dose to||
4198|167|D|catch up.||
4198|168|B|||
4198|169|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
4198|170|R|medications away from children and pets.||
4198|171|R|   Do not flush medications down the toilet or pour them into a||
4198|172|R|drain unless instructed to do so. Properly discard this product||
4198|173|R|when it is expired or no longer needed. Consult your pharmacist||
4198|174|R|or local waste disposal company.||
4198|175|B|||
4198|176|A|Information last revised May 2024.||
4198|177|A|Copyright(c) 2025 First Databank, Inc.||
4198|178|B|||
4202|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4202|002|Z|does NOT have all possible information about this product. This||
4202|003|Z|information does not assure that this product is safe, effective,||
4202|004|Z|or appropriate for you. This information is not individual||
4202|005|Z|medical advice and does not substitute for the advice of your||
4202|006|Z|health care professional. Always ask your health care||
4202|007|Z|professional for complete information about this product and your||
4202|008|Z|specific health needs.||
4202|009|B|||
4202|010|T|SODIUM PHENYLBUTYRATE - ORAL||
4202|011|F|(SOE-dee-um FEN-il-BUE-ti-rate)||
4202|012|B|||
4202|013|C|COMMON BRAND NAME(S): Buphenyl||
4202|014|B|||
4202|015|U|USES:  This medication is used along with diet changes for||
4202|016|U|long-term treatment of a certain inherited disorder (urea cycle||
4202|017|U|disorder). Sodium phenylbutyrate helps remove a certain chemical||
4202|018|U|(ammonia) from the body. Too much ammonia in the body can cause||
4202|019|U|brain damage and sometimes death.||
4202|020|U|   This medication should not be used to treat sudden, severely||
4202|021|U|high levels of ammonia in the body. Get medical help right away||
4202|022|U|if you have sudden symptoms of too much ammonia (such as trouble||
4202|023|U|thinking, nausea, vomiting, irritability, trouble speaking,||
4202|024|U|trouble walking, fainting).||
4202|025|B|||
4202|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4202|027|H|from your pharmacist before you start using sodium phenylbutyrate||
4202|028|H|and each time you get a refill. If you have any questions, ask||
4202|029|H|your doctor or pharmacist.||
4202|030|H|   Take this medication by mouth exactly as directed by your||
4202|031|H|doctor. The dosage is based on your weight or body size, medical||
4202|032|H|condition, and response to treatment. The total daily dose should||
4202|033|H|be divided into equal amounts and taken with each meal or feeding||
4202|034|H|(such as 3 to 6 times daily). Do not increase or decrease your||
4202|035|H|dose without your doctor's approval.||
4202|036|H|   Use this medication regularly to get the most benefit from it.||
4202|037|H|To help you remember, take it at the same times each day.||
4202|038|B|||
4202|039|S|SIDE EFFECTS:  Loss of appetite or menstrual changes||
4202|040|S|(delayed/irregular/absent periods) may occur. If any of these||
4202|041|S|effects last or get worse, tell your doctor or pharmacist||
4202|042|S|promptly.||
4202|043|S|   Remember that this medication has been prescribed because your||
4202|044|S|doctor has judged that the benefit to you is greater than the||
4202|045|S|risk of side effects. Many people using this medication do not||
4202|046|S|have serious side effects.||
4202|047|S|   Tell your doctor right away if you have any serious side||
4202|048|S|effects, including: drowsiness/lightheadedness, fast/pounding||
4202|049|S|heartbeat, mental/mood changes (such as confusion), unusual||
4202|050|S|tiredness.||
4202|051|S|   A very serious allergic reaction to this drug is rare.||
4202|052|S|However, get medical help right away if you notice any symptoms||
4202|053|S|of a serious allergic reaction, including: rash, itching/swelling||
4202|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4202|055|S|breathing.||
4202|056|S|   This is not a complete list of possible side effects. If you||
4202|057|S|notice other effects not listed above, contact your doctor or||
4202|058|S|pharmacist.||
4202|059|S|   In the US -||
4202|060|S|   Call your doctor for medical advice about side effects. You||
4202|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4202|062|S|www.fda.gov/medwatch.||
4202|063|S|   In Canada - Call your doctor for medical advice about side||
4202|064|S|effects. You may report side effects to Health Canada at||
4202|065|S|1-866-234-2345.||
4202|066|B|||
4202|067|P|PRECAUTIONS:  Before taking sodium phenylbutyrate, tell your||
4202|068|P|doctor or pharmacist if you are allergic to it; or if you have||
4202|069|P|any other allergies. This product may contain inactive||
4202|070|P|ingredients, which can cause allergic reactions or other||
4202|071|P|problems. Talk to your pharmacist for more details.||
4202|072|P|   Before using this medication, tell your doctor or pharmacist||
4202|073|P|your medical history, especially of: a certain heart problem||
4202|074|P|(heart failure), kidney disease, liver disease, swelling (edema).||
4202|075|P|   This medication contains salt (sodium). Before taking this||
4202|076|P|medication, tell your doctor or pharmacist if you are on a||
4202|077|P|low-salt diet.||
4202|078|P|   Before having surgery, tell your doctor or dentist about all||
4202|079|P|the products you use (including prescription drugs,||
4202|080|P|nonprescription drugs, and herbal products).||
4202|081|P|   During pregnancy, this medication should be used only when||
4202|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
4202|083|P|   It is unknown if this medication passes into breast milk.||
4202|084|P|Consult your doctor before breastfeeding.||
4202|085|B|||
4202|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4202|087|I|medications work or increase your risk for serious side effects.||
4202|088|I|This document does not contain all possible drug interactions.||
4202|089|I|Keep a list of all the products you use (including||
4202|090|I|prescription/nonprescription drugs and herbal products) and share||
4202|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
4202|092|I|the dosage of any medicines without your doctor's approval.||
4202|093|B|||
4202|094|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4202|095|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4202|096|O|poison control center right away. US residents can call||
4202|097|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4202|098|B|||
4202|099|N|NOTES:  Do not share this medication with others.||
4202|100|N|   Lab and/or medical tests (such as plasma ammonia/amino acid||
4202|101|N|levels, complete blood count, blood potassium level, urine tests,||
4202|102|N|drug levels) should be done while you are taking this medication.||
4202|103|N|Keep all medical and lab appointments. Consult your doctor for||
4202|104|N|more details.||
4202|105|B|||
4202|106|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4202|107|D|remember. If it is near the time of the next dose, skip the||
4202|108|D|missed dose. Take your next dose at the regular time. Do not||
4202|109|D|double the dose to catch up.||
4202|110|B|||
4202|111|R|STORAGE:  Store at room temperature away from light and moisture.||
4202|112|R|Do not store in the bathroom. Keep all medications away from||
4202|113|R|children and pets.||
4202|114|R|   Do not flush medications down the toilet or pour them into a||
4202|115|R|drain unless instructed to do so. Properly discard this product||
4202|116|R|when it is expired or no longer needed. Consult your pharmacist||
4202|117|R|or local waste disposal company.||
4202|118|B|||
4202|119|A|Information last revised January 2025.||
4202|120|A|Copyright(c) 2025 First Databank, Inc.||
4202|121|B|||
4207|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4207|002|Z|does NOT have all possible information about this product. This||
4207|003|Z|information does not assure that this product is safe, effective,||
4207|004|Z|or appropriate for you. This information is not individual||
4207|005|Z|medical advice and does not substitute for the advice of your||
4207|006|Z|health care professional. Always ask your health care||
4207|007|Z|professional for complete information about this product and your||
4207|008|Z|specific health needs.||
4207|009|B|||
4207|010|T|DIHYDROERGOTAMINE - NASAL||
4207|011|F|(dye-HI-dro-er-GOT-uh-meen)||
4207|012|B|||
4207|013|C|COMMON BRAND NAME(S): Migranal||
4207|014|B|||
4207|015|W|WARNING:  This medication has rarely caused a very serious lack||
4207|016|W|of blood flow to the hands and feet (peripheral ischemia) or to||
4207|017|W|the brain, which could cause a stroke. The risk is increased when||
4207|018|W|this medication is taken with other drugs that can affect the||
4207|019|W|removal of dihydroergotamine from your body. Examples include||
4207|020|W|azole antifungals (such as ketoconazole, itraconazole),||
4207|021|W|cobicistat, mifepristone, certain antidepressants (such as||
4207|022|W|nefazodone), macrolide antibiotics (such as clarithromycin,||
4207|023|W|erythromycin, troleandomycin), HIV protease inhibitors (such as||
4207|024|W|ritonavir, nelfinavir, indinavir), SSRIs (such as fluoxetine,||
4207|025|W|paroxetine, fluvoxamine), among others.||
4207|026|B|||
4207|027|U|USES:  This medication is used to treat migraine headache||
4207|028|U|attacks. It helps relieve headache pain and other symptoms such||
4207|029|U|as sensitivity to light or sound. Prompt treatment allows you to||
4207|030|U|get back to your normal routine sooner and may decrease your need||
4207|031|U|for other pain medications. This medication is not used to||
4207|032|U|prevent migraines from occurring.||
4207|033|U|   Dihydroergotamine belongs to a class of drugs known as ergot||
4207|034|U|alkaloids. It may work by narrowing the blood vessels in the||
4207|035|U|brain. It may also block other pain pathways in the brain.||
4207|036|B|||
4207|037|H|HOW TO USE:  Read the Patient Information Leaflet or Medication||
4207|038|H|Guide provided by your pharmacist before you start using||
4207|039|H|dihydroergotamine and each time you get a refill. Follow the||
4207|040|H|illustrated directions for the proper use of this medication. If||
4207|041|H|you have any questions, ask your doctor or pharmacist.||
4207|042|H|   Learn all preparation and usage instructions in the product||
4207|043|H|package. If any of the information is unclear, consult your||
4207|044|H|doctor or pharmacist.||
4207|045|H|   This medication comes in individual nasal spray vials. Each||
4207|046|H|vial contains enough medication to treat a single migraine||
4207|047|H|attack. Do not use more than 4 sprays for a single attack. Before||
4207|048|H|using each nasal spray vial, prime the pump by spraying 4 times||
4207|049|H|into the air, away from the face.||
4207|050|H|   At the first sign of a migraine, spray this medication into||
4207|051|H|the nostrils. Do not inject this medication. Use 1 spray into||
4207|052|H|each nostril. Do not tilt your head back, sniff through your||
4207|053|H|nose, or blow your nose while spraying or immediately after. Use||
4207|054|H|another spray into each nostril 15 minutes after the first||
4207|055|H|sprays, or use as directed by your doctor. After using the||
4207|056|H|medication, you should lie down and relax in a quiet, darkened||
4207|057|H|room. The maximum number of sprays you can use for a single||
4207|058|H|attack is 4 sprays (two in each nostril). You should feel some||
4207|059|H|relief within 30 minutes of using this medication.||
4207|060|H|   The dosage is based on your medical condition and response to||
4207|061|H|treatment. Ask your doctor how often you can use this medication||
4207|062|H|to treat your migraine headaches. Do not increase your dose or||
4207|063|H|use this drug more often or for longer than prescribed. Your||
4207|064|H|condition will not improve any faster, and your risk of side||
4207|065|H|effects will increase.||
4207|066|H|   This medication works best if it is used as the first signs of||
4207|067|H|the headache occur. If you wait until the headache has worsened,||
4207|068|H|the medication may not work as well. Use only as needed to treat||
4207|069|H|migraine attacks when they occur. It is not meant for long-term||
4207|070|H|daily use.||
4207|071|H|   If you have never used this medication before and you have||
4207|072|H|risk factors for heart disease (see Precautions), you may need to||
4207|073|H|be monitored for rare but serious side effects (such as chest||
4207|074|H|pain) when you take the first dose. Your doctor may ask you to||
4207|075|H|take the first dose in the office.||
4207|076|H|   If you also take "triptan" or other ergot medications (such as||
4207|077|H|sumatriptan, methysergide), wait 24 hours before and after taking||
4207|078|H|dihydroergotamine. Consult your doctor or pharmacist for more||
4207|079|H|details and for advice on how to time your doses of these||
4207|080|H|medications.||
4207|081|H|   If you are using drugs for migraine attacks on 10 or more days||
4207|082|H|each month, the drugs may actually make your headaches worse||
4207|083|H|(medication overuse headache). Do not use medications more often||
4207|084|H|or for longer than directed. Tell your doctor if you need to use||
4207|085|H|this medication more often, or if the medication is not working||
4207|086|H|as well, or if your headaches get worse.||
4207|087|B|||
4207|088|S|SIDE EFFECTS:  See also Warning section.||
4207|089|S|   Sore nose/throat, stuffy/runny nose, changes in taste,||
4207|090|S|dizziness, or nausea may occur. If any of these effects last or||
4207|091|S|get worse, tell your doctor or pharmacist promptly.||
4207|092|S|   Remember that this medication has been prescribed because your||
4207|093|S|doctor has judged that the benefit to you is greater than the||
4207|094|S|risk of side effects. Many people using this medication do not||
4207|095|S|have serious side effects.||
4207|096|S|   This medication may raise your blood pressure. Check your||
4207|097|S|blood pressure regularly and tell your doctor if the results are||
4207|098|S|high.||
4207|099|S|   This medication may rarely cause a very serious lack of blood||
4207|100|S|flow. Stop using dihydroergotamine and tell your doctor right||
4207|101|S|away if you have any serious side effects, including: slow/fast||
4207|102|S|heartbeat, weakness in the legs, muscle pain in the arms/legs,||
4207|103|S|tingling/numbness, feeling of coldness in the hands/feet, blue||
4207|104|S|fingers/toes, severe stomach/abdominal pain.||
4207|105|S|   Get medical help right away if you have any very serious side||
4207|106|S|effects, including: jaw/left arm pain, chest pain/pressure,||
4207|107|S|sudden tiredness, weakness on one side of the body, trouble||
4207|108|S|speaking, vision changes, mental/mood changes (such as||
4207|109|S|confusion).||
4207|110|S|   A very serious allergic reaction to this drug is rare.||
4207|111|S|However, get medical help right away if you notice any symptoms||
4207|112|S|of a serious allergic reaction, including: rash, itching/swelling||
4207|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4207|114|S|breathing.||
4207|115|S|   This is not a complete list of possible side effects. If you||
4207|116|S|notice other effects not listed above, contact your doctor or||
4207|117|S|pharmacist.||
4207|118|S|   In the US -||
4207|119|S|   Call your doctor for medical advice about side effects. You||
4207|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4207|121|S|www.fda.gov/medwatch.||
4207|122|S|   In Canada - Call your doctor for medical advice about side||
4207|123|S|effects. You may report side effects to Health Canada at||
4207|124|S|1-866-234-2345.||
4207|125|B|||
4207|126|P|PRECAUTIONS:  Before using dihydroergotamine, tell your doctor or||
4207|127|P|pharmacist if you are allergic to it; or to other ergot alkaloids||
4207|128|P|(such as ergotamine, methysergide, bromocriptine); or if you have||
4207|129|P|any other allergies. This product may contain inactive||
4207|130|P|ingredients, which can cause allergic reactions or other||
4207|131|P|problems. Talk to your pharmacist for more details.||
4207|132|P|   Before using this medication, tell your doctor or pharmacist||
4207|133|P|your medical history, especially: heart disease (such as chest||
4207|134|P|pain/angina, heart attack), high blood pressure, high||
4207|135|P|cholesterol, diabetes, smoking/tobacco use, family history of||
4207|136|P|heart disease, stroke, blood circulation disease (such as||
4207|137|P|peripheral arterial disease, Raynaud's disease), severe blood||
4207|138|P|infection (sepsis), stomach/intestinal problems (such as ischemic||
4207|139|P|bowel syndrome), kidney disease, liver disease, headaches with||
4207|140|P|unusual symptoms or certain types of headache||
4207|141|P|(hemiplegic/basilar), recent blood vessel surgery, permanent||
4207|142|P|ending of menstrual periods due to age/surgery/hormonal changes||
4207|143|P|(post-menopausal), nasal problems (such as chronic congestion,||
4207|144|P|nasal allergies).||
4207|145|P|   If you are at high risk for heart disease, your doctor may||
4207|146|P|want to check your heart before prescribing dihydroergotamine and||
4207|147|P|give your first dose in the office.||
4207|148|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4207|149|P|can make you more dizzy. Do not drive, use machinery, or do||
4207|150|P|anything that needs alertness until you can do it safely. Limit||
4207|151|P|alcoholic beverages. Talk to your doctor if you are using||
4207|152|P|marijuana (cannabis).||
4207|153|P|   Using tobacco/nicotine products while using this medication||
4207|154|P|can increase the risk of serious side effects such as heart||
4207|155|P|problems (such as chest pain, fast/slow/irregular heartbeat) and||
4207|156|P|decreased blood supply to the brain/hands/feet. Do not use||
4207|157|P|tobacco while taking this medication. If you smoke, talk to your||
4207|158|P|doctor about how to stop smoking.||
4207|159|P|   Before having surgery, tell your doctor or dentist about all||
4207|160|P|the products you use (including prescription drugs,||
4207|161|P|nonprescription drugs, and herbal products).||
4207|162|P|   Tell your doctor if you are pregnant or plan to become||
4207|163|P|pregnant. You should not become pregnant while using||
4207|164|P|dihydroergotamine. Dihydroergotamine may harm an unborn baby. If||
4207|165|P|you become pregnant, talk to your doctor right away about the||
4207|166|P|risks and benefits of this medication.||
4207|167|P|   This drug may pass into breast milk. Because of the possible||
4207|168|P|risk to the infant, breastfeeding is not recommended while using||
4207|169|P|this drug and for 3 days after the last dose. Consult your doctor||
4207|170|P|before breastfeeding.||
4207|171|B|||
4207|172|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
4207|173|I|   Drug interactions may change how your medications work or||
4207|174|I|increase your risk for serious side effects. This document does||
4207|175|I|not contain all possible drug interactions. Keep a list of all||
4207|176|I|the products you use (including prescription/nonprescription||
4207|177|I|drugs and herbal products) and share it with your doctor and||
4207|178|I|pharmacist. Do not start, stop, or change the dosage of any||
4207|179|I|medicines without your doctor's approval.||
4207|180|I|   Some products have ingredients that could raise your heart||
4207|181|I|rate or blood pressure. Tell your pharmacist what products you||
4207|182|I|are using, and ask how to use them safely (especially||
4207|183|I|cough-and-cold products, bronchodilators, stimulants, diet aids,||
4207|184|I|or other migraine medications).||
4207|185|B|||
4207|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4207|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4207|188|O|poison control center right away. US residents can call||
4207|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4207|190|O|Symptoms of overdose may include: severe/sudden numbness, blue or||
4207|191|O|purple hands/feet, slow/difficult breathing, confusion, seizures.||
4207|192|B|||
4207|193|N|NOTES:  Do not share this medication with others.||
4207|194|N|   Lab and/or medical tests (such as EKG) may need to be done||
4207|195|N|while you are using this medication. Keep all medical and lab||
4207|196|N|appointments. Consult your doctor for more details.||
4207|197|N|   Certain foods/beverages or food additives (such as red wine,||
4207|198|N|cheese, chocolate, monosodium glutamate, alcohol) as well as some||
4207|199|N|lifestyle patterns (such as irregular eating/sleeping habits,||
4207|200|N|stress) may bring about a migraine headache. Avoiding these||
4207|201|N|"triggers" may help decrease the frequency of migraine headaches.||
4207|202|N|Consult your doctor for more details.||
4207|203|B|||
4207|204|D|MISSED DOSE:  Take this medication only as needed when a migraine||
4207|205|D|occurs, as directed by your doctor. This medication is not taken||
4207|206|D|on a regular schedule.||
4207|207|B|||
4207|208|R|STORAGE:  Store at room temperature away from heat and light. Do||
4207|209|R|not freeze or refrigerate. Once the nasal spray vial is opened,||
4207|210|R|this medication expires after 8 hours. Keep all medications away||
4207|211|R|from children and pets.||
4207|212|R|   Do not flush medications down the toilet or pour them into a||
4207|213|R|drain unless instructed to do so. Properly discard this product||
4207|214|R|when it is expired or no longer needed. Consult your pharmacist||
4207|215|R|or local waste disposal company.||
4207|216|B|||
4207|217|A|Information last revised July 2025.||
4207|218|A|Copyright(c) 2025 First Databank, Inc.||
4207|219|B|||
4217|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4217|002|Z|does NOT have all possible information about this product. This||
4217|003|Z|information does not assure that this product is safe, effective,||
4217|004|Z|or appropriate for you. This information is not individual||
4217|005|Z|medical advice and does not substitute for the advice of your||
4217|006|Z|health care professional. Always ask your health care||
4217|007|Z|professional for complete information about this product and your||
4217|008|Z|specific health needs.||
4217|009|B|||
4217|010|T|LAMOTRIGINE CHEWABLE/DISPERSIBLE TABLET - ORAL||
4217|011|F|(lam-OH-try-jeen)||
4217|012|B|||
4217|013|C|COMMON BRAND NAME(S): Lamictal||
4217|014|B|||
4217|015|W|WARNING:  Rarely, serious (sometimes fatal) skin rashes have||
4217|016|W|occurred while taking this medication. These rashes are more||
4217|017|W|common in children than in adults. Rashes may be more likely if||
4217|018|W|you start at too high a dose, if you increase your dose too||
4217|019|W|quickly, or if you take this medication with certain other||
4217|020|W|anti-seizure medications (valproic acid, divalproex). These||
4217|021|W|rashes may occur anytime during use, but most serious rashes have||
4217|022|W|occurred within 2 to 8 weeks of starting lamotrigine.||
4217|023|W|   Get medical help right away if you develop any type of skin||
4217|024|W|rash, or if you have other signs of a serious allergic reaction||
4217|025|W|such as hives, fever, swollen lymph nodes, severe dizziness,||
4217|026|W|painful sores in the mouth or around the eyes, swelling of the||
4217|027|W|face/tongue/throat, trouble breathing, or liver problems||
4217|028|W|(symptoms include stomach/abdominal pain, nausea/vomiting that||
4217|029|W|continues, dark urine, yellowing eyes/skin). Your doctor will||
4217|030|W|tell you if you should stop taking lamotrigine. Even after you||
4217|031|W|stop taking this, it is still possible for a rash to become||
4217|032|W|life-threatening or cause permanent scars or other problems.||
4217|033|B|||
4217|034|U|USES:  Lamotrigine is used alone or with other medications to||
4217|035|U|prevent and control seizures. It may also be used to help prevent||
4217|036|U|the extreme mood swings of bipolar disorder in adults.||
4217|037|U|   Lamotrigine is known as an anticonvulsant or antiepileptic||
4217|038|U|drug. It is thought to work by restoring the balance of certain||
4217|039|U|natural substances in the brain.||
4217|040|U|   This drug is not approved for use in children younger than 2||
4217|041|U|years due to an increased risk of side effects (such as||
4217|042|U|infections).||
4217|043|B|||
4217|044|V|OTHER USES:  This section contains uses of this drug that are not||
4217|045|V|listed in the approved professional labeling for the drug but||
4217|046|V|that may be prescribed by your health care professional. Use this||
4217|047|V|drug for a condition that is listed in this section only if it||
4217|048|V|has been so prescribed by your health care professional.||
4217|049|V|   This medication may also be used for nerve pain.||
4217|050|B|||
4217|051|H|HOW TO USE:  Read the Medication Guide and, if available, the||
4217|052|H|Patient Information Leaflet provided by your pharmacist before||
4217|053|H|you start taking lamotrigine and each time you get a refill. If||
4217|054|H|you have any questions, ask your doctor or pharmacist.||
4217|055|H|   Take this medication by mouth with or without food as directed||
4217|056|H|by your doctor. The chewable/dispersible tablets may be swallowed||
4217|057|H|whole, chewed, or mixed in water or fruit juice. If the tablets||
4217|058|H|are chewed, drink a small amount of water or juice to help you||
4217|059|H|swallow all of the medication. To disperse the tablets, add your||
4217|060|H|dose to a small amount of liquid (enough to cover the medication)||
4217|061|H|in a glass or spoon. Wait 1 minute until the tablets are||
4217|062|H|completely dissolved, stir, then drink the entire mixture right||
4217|063|H|away. Use only whole tablets. Do not use partial tablets.||
4217|064|H|   The dosage is based on your medical condition, response to||
4217|065|H|treatment, and other medications you may be taking. Children's||
4217|066|H|dosage is also based on weight. Be sure to tell your doctor and||
4217|067|H|pharmacist about all the products you use (including prescription||
4217|068|H|drugs, nonprescription drugs, and herbal products).||
4217|069|H|   It is very important to follow your doctor's dosing||
4217|070|H|instructions exactly. The dose must be increased slowly. It may||
4217|071|H|take several weeks or months to reach the best dose for you and||
4217|072|H|to get the full benefit from this medication. Take this||
4217|073|H|medication regularly in order to get the most benefit from it. To||
4217|074|H|help you remember, take it at the same time(s) each day.||
4217|075|H|   Do not stop taking this medication without consulting your||
4217|076|H|doctor. Some conditions may become worse when the drug is||
4217|077|H|suddenly stopped. Your dose may need to be gradually decreased.||
4217|078|H|Also, if you have stopped taking this medication, do not restart||
4217|079|H|lamotrigine without consulting your doctor.||
4217|080|H|   Tell your doctor if your condition does not get better or if||
4217|081|H|it gets worse.||
4217|082|B|||
4217|083|S|SIDE EFFECTS:  See also Warning section.||
4217|084|S|   Dizziness, drowsiness, headache, vomiting, or upset stomach||
4217|085|S|may occur. If any of these effects last or get worse, tell your||
4217|086|S|doctor or pharmacist promptly.||
4217|087|S|   Remember that this medication has been prescribed because your||
4217|088|S|doctor has judged that the benefit to you is greater than the||
4217|089|S|risk of side effects. Many people using this medication do not||
4217|090|S|have serious side effects.||
4217|091|S|   A small number of people who take anticonvulsants for any||
4217|092|S|condition (such as seizures, bipolar disorder, pain) may||
4217|093|S|experience depression, suicidal thoughts/attempts, or other||
4217|094|S|mental/mood problems. Tell your doctor right away if you or your||
4217|095|S|family/caregiver notice any unusual/sudden changes in your mood,||
4217|096|S|thoughts, or behavior including signs of depression, suicidal||
4217|097|S|thoughts/attempts, thoughts about harming yourself.||
4217|098|S|   Get medical help right away if you have any very serious side||
4217|099|S|effects, including: fainting, fast/slow/irregular/pounding||
4217|100|S|heartbeat, easy or unusual bruising/bleeding, stiff neck, vision||
4217|101|S|problems, loss of coordination, muscle pain/tenderness/weakness,||
4217|102|S|signs of kidney problems (such as change in the amount of urine).||
4217|103|S|   This is not a complete list of possible side effects. If you||
4217|104|S|notice other effects not listed above, contact your doctor or||
4217|105|S|pharmacist.||
4217|106|S|   In the US -||
4217|107|S|   Call your doctor for medical advice about side effects. You||
4217|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4217|109|S|www.fda.gov/medwatch.||
4217|110|S|   In Canada - Call your doctor for medical advice about side||
4217|111|S|effects. You may report side effects to Health Canada at||
4217|112|S|1-866-234-2345.||
4217|113|B|||
4217|114|P|PRECAUTIONS:  Before taking lamotrigine, tell your doctor or||
4217|115|P|pharmacist if you are allergic to it; or if you have any other||
4217|116|P|allergies. This product may contain inactive ingredients, which||
4217|117|P|can cause allergic reactions or other problems. Talk to your||
4217|118|P|pharmacist for more details.||
4217|119|P|   Before using this medication, tell your doctor or pharmacist||
4217|120|P|your medical history, especially of: kidney disease, liver||
4217|121|P|disease, heart problems (such as irregular heartbeat, heart||
4217|122|P|block, heart failure).||
4217|123|P|   This drug may make you dizzy or drowsy or blur your vision.||
4217|124|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
4217|125|P|drowsy. Do not drive, use machinery, or do anything that needs||
4217|126|P|alertness or clear vision until you can do it safely. Limit||
4217|127|P|alcoholic beverages. Talk to your doctor if you are using||
4217|128|P|marijuana (cannabis).||
4217|129|P|   Children may be at greater risk for skin rashes while taking||
4217|130|P|this drug. See also Warning section.||
4217|131|P|   Before having surgery, tell your doctor or dentist about all||
4217|132|P|the products you use (including prescription drugs,||
4217|133|P|nonprescription drugs, and herbal products).||
4217|134|P|   Older adults may be more sensitive to the side effects of this||
4217|135|P|drug, especially dizziness, loss of coordination, or fainting.||
4217|136|P|These side effects can increase the risk of falling.||
4217|137|P|   During pregnancy, this medication should be used only when||
4217|138|P|clearly needed. Discuss the risks and benefits with your doctor.||
4217|139|P|   This drug passes into breast milk and may have undesirable||
4217|140|P|effects on a nursing infant. Consult your doctor before||
4217|141|P|breastfeeding.||
4217|142|B|||
4217|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4217|144|I|medications work or increase your risk for serious side effects.||
4217|145|I|This document does not contain all possible drug interactions.||
4217|146|I|Keep a list of all the products you use (including||
4217|147|I|prescription/nonprescription drugs and herbal products) and share||
4217|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
4217|149|I|the dosage of any medicines without your doctor's approval.||
4217|150|I|   Some products that may interact with this drug include:||
4217|151|I|dofetilide, orlistat.||
4217|152|I|   Other medications can affect the removal of lamotrigine from||
4217|153|I|your body, which may affect how lamotrigine works. Examples||
4217|154|I|include hormonal birth control (such as pills, patches),||
4217|155|I|estrogens, other medications to treat seizures (such as||
4217|156|I|phenobarbital, primidone, valproic acid), rifampin, ritonavir,||
4217|157|I|among others. Your doctor may need to adjust your dose of||
4217|158|I|lamotrigine if you are on these medications.||
4217|159|I|   This medication may decrease the effectiveness of hormonal||
4217|160|I|birth control such as pills, patch, or ring. This could cause||
4217|161|I|pregnancy. Discuss with your doctor or pharmacist if you should||
4217|162|I|use reliable backup birth control methods while using this||
4217|163|I|medication. Also tell your doctor if you have any new spotting or||
4217|164|I|breakthrough bleeding, because these may be signs that your birth||
4217|165|I|control is not working well.||
4217|166|I|   Tell your doctor or pharmacist if you are taking other||
4217|167|I|products that cause drowsiness including alcohol, marijuana||
4217|168|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
4217|169|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
4217|170|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
4217|171|I|codeine).||
4217|172|I|   Check the labels on all your medicines (such as allergy or||
4217|173|I|cough-and-cold products) because they may contain ingredients||
4217|174|I|that cause drowsiness. Ask your pharmacist about using those||
4217|175|I|products safely.||
4217|176|I|   This medication may interfere with certain lab tests (such as||
4217|177|I|urine drug screening tests), possibly causing false test results.||
4217|178|I|Make sure lab personnel and all your doctors know you use this||
4217|179|I|drug.||
4217|180|B|||
4217|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4217|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4217|183|O|poison control center right away. US residents can call||
4217|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4217|185|O|Symptoms of overdose may include: severe drowsiness, unusual eye||
4217|186|O|movements, loss of consciousness.||
4217|187|B|||
4217|188|N|NOTES:  Do not share this medication with others.||
4217|189|N|   Lab and/or medical tests (such as liver/kidney function,||
4217|190|N|complete blood count) may be done while you are taking this||
4217|191|N|medication. Keep all medical and lab appointments. Consult your||
4217|192|N|doctor for more details.||
4217|193|N|   There are different types of this medication available. Some||
4217|194|N|do not have the same effects. There are also some medications||
4217|195|N|that sound the same as this product. Make sure you have the right||
4217|196|N|product before taking it.||
4217|197|B|||
4217|198|D|MISSED DOSE:  It is important to take each dose at the scheduled||
4217|199|D|time. If you miss a dose, take it as soon as you remember. If it||
4217|200|D|is near the time of the next dose, skip the missed dose. Take||
4217|201|D|your next dose at the regular time. Do not double the dose to||
4217|202|D|catch up.||
4217|203|B|||
4217|204|R|STORAGE:  Store at room temperature away from light and moisture.||
4217|205|R|Do not store in the bathroom. Keep all medications away from||
4217|206|R|children and pets.||
4217|207|R|   Do not flush medications down the toilet or pour them into a||
4217|208|R|drain unless instructed to do so. Properly discard this product||
4217|209|R|when it is expired or no longer needed. Consult your pharmacist||
4217|210|R|or local waste disposal company.||
4217|211|B|||
4217|212|M|MEDICAL ALERT:  Your condition can cause complications in a||
4217|213|M|medical emergency. For information about enrolling in MedicAlert,||
4217|214|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4217|215|B|||
4217|216|A|Information last revised October 2024.||
4217|217|A|Copyright(c) 2025 First Databank, Inc.||
4217|218|B|||
4222|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4222|002|Z|does NOT have all possible information about this product. This||
4222|003|Z|information does not assure that this product is safe, effective,||
4222|004|Z|or appropriate for you. This information is not individual||
4222|005|Z|medical advice and does not substitute for the advice of your||
4222|006|Z|health care professional. Always ask your health care||
4222|007|Z|professional for complete information about this product and your||
4222|008|Z|specific health needs.||
4222|009|B|||
4222|010|T|IPRATROPIUM 0.03% SPRAY - NASAL||
4222|011|F|(IP-ra-TROE-pee-um)||
4222|012|B|||
4222|013|C|COMMON BRAND NAME(S): Atrovent||
4222|014|B|||
4222|015|U|USES:  Ipratropium is used to treat a runny nose that occurs||
4222|016|U|throughout the year. It works by reducing the amount of||
4222|017|U|fluid/mucus released from inside your nose.||
4222|018|U|   This medication does not relieve symptoms of stuffy nose,||
4222|019|U|sneezing, or postnasal drip.||
4222|020|B|||
4222|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4222|022|H|from your pharmacist before you start using ipratropium and each||
4222|023|H|time you get a refill. Learn how to use this spray properly. If||
4222|024|H|you have any questions, ask your doctor or pharmacist.||
4222|025|H|   Follow the instructions for priming the spray if you are using||
4222|026|H|it for the first time or if you have not used it for more than 24||
4222|027|H|hours. When priming the spray, make sure to spray away from the||
4222|028|H|face so that you do not get the medication into your eyes.||
4222|029|H|   Gently blow your nose before using this drug. Spray this||
4222|030|H|medication into the nose as directed by your doctor, usually 2 or||
4222|031|H|3 times a day in each nostril.||
4222|032|H|   The dosage is based on your medical condition and response to||
4222|033|H|treatment.||
4222|034|H|   Avoid getting this medication into your eyes. It may cause eye||
4222|035|H|pain/irritation, temporary blurred vision, and other vision||
4222|036|H|changes. If this medication does get into your eyes, flush your||
4222|037|H|eyes with water for a few minutes. Tell your doctor right away if||
4222|038|H|any symptoms occur.||
4222|039|H|   Use this medication regularly in order to get the most benefit||
4222|040|H|from it. This medication works best if used at evenly spaced||
4222|041|H|intervals. To help you remember, use it at the same times each||
4222|042|H|day. Do not increase your dose, use this medication more often,||
4222|043|H|or stop using it without first consulting your doctor.||
4222|044|H|   If the spray gets clogged, hold the nasal tip under warm||
4222|045|H|running water for about a minute. Dry the nasal tip and prime the||
4222|046|H|spray again. Do not use a sharp object to clear the spray.||
4222|047|H|   You may start to feel better on the first day after using this||
4222|048|H|medication, but it may take up to 2 weeks before you get the full||
4222|049|H|benefit of this medication. Tell your doctor if your condition||
4222|050|H|does not get better or if it gets worse.||
4222|051|B|||
4222|052|S|SIDE EFFECTS:  See also How to Use section.||
4222|053|S|   Dry/bloody nose, dry mouth/throat, throat irritation, bad||
4222|054|S|taste in mouth, nausea, dizziness, or constipation may occur. If||
4222|055|S|any of these effects last or get worse, tell your doctor or||
4222|056|S|pharmacist promptly.||
4222|057|S|   Remember that this medication has been prescribed because your||
4222|058|S|doctor has judged that the benefit to you is greater than the||
4222|059|S|risk of side effects. Many people using this medication do not||
4222|060|S|have serious side effects.||
4222|061|S|   Tell your doctor right away if you have any serious side||
4222|062|S|effects, including: difficult/painful urination, fast/pounding||
4222|063|S|heartbeat.||
4222|064|S|   Get medical help right away if you have any very serious side||
4222|065|S|effects, including: eye pain/swelling/redness, vision changes||
4222|066|S|(such as seeing rainbows around lights at night, blurred vision).||
4222|067|S|   A very serious allergic reaction to this product is rare.||
4222|068|S|However, get medical help right away if you notice any symptoms||
4222|069|S|of a serious allergic reaction, including: rash, itching/swelling||
4222|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4222|071|S|breathing.||
4222|072|S|   This is not a complete list of possible side effects. If you||
4222|073|S|notice other effects not listed above, contact your doctor or||
4222|074|S|pharmacist.||
4222|075|S|   In the US -||
4222|076|S|   Call your doctor for medical advice about side effects. You||
4222|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4222|078|S|www.fda.gov/medwatch.||
4222|079|S|   In Canada - Call your doctor for medical advice about side||
4222|080|S|effects. You may report side effects to Health Canada at||
4222|081|S|1-866-234-2345.||
4222|082|B|||
4222|083|P|PRECAUTIONS:  Before using ipratropium, tell your doctor or||
4222|084|P|pharmacist if you are allergic to it or to tiotropium; or to||
4222|085|P|atropine or other belladonna-type drugs; or if you have any other||
4222|086|P|allergies. This product may contain inactive ingredients, which||
4222|087|P|can cause allergic reactions or other problems. Talk to your||
4222|088|P|pharmacist for more details.||
4222|089|P|   Before using this medication, tell your doctor or pharmacist||
4222|090|P|your medical history, especially of: personal or family history||
4222|091|P|of glaucoma (angle-closure type), difficulty urinating (for||
4222|092|P|example, due to enlarged prostate).||
4222|093|P|   Although unlikely, this drug may make you dizzy or blur your||
4222|094|P|vision or cause other vision changes. Alcohol or marijuana||
4222|095|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
4222|096|P|or do anything that needs alertness or clear vision until you can||
4222|097|P|do it safely. Limit alcoholic beverages. Talk to your doctor if||
4222|098|P|you are using marijuana (cannabis).||
4222|099|P|   Before having surgery, tell your doctor or dentist about all||
4222|100|P|the products you use (including prescription drugs,||
4222|101|P|nonprescription drugs, and herbal products).||
4222|102|P|   Older adults may be more sensitive to the side effects of this||
4222|103|P|drug, especially problems urinating or constipation.||
4222|104|P|   During pregnancy, this medication should be used only when||
4222|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
4222|106|P|   It is unknown if this medication passes into breast milk.||
4222|107|P|Consult your doctor before breastfeeding.||
4222|108|B|||
4222|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4222|110|I|medications work or increase your risk for serious side effects.||
4222|111|I|This document does not contain all possible drug interactions.||
4222|112|I|Keep a list of all the products you use (including||
4222|113|I|prescription/nonprescription drugs and herbal products) and share||
4222|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
4222|115|I|the dosage of any medicines without your doctor's approval.||
4222|116|B|||
4222|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4222|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4222|119|O|poison control center right away. US residents can call||
4222|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4222|121|B|||
4222|122|N|NOTES:  Do not share this medication with others.||
4222|123|B|||
4222|124|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4222|125|D|If it is near the time of the next dose, skip the missed dose.||
4222|126|D|Use your next dose at the regular time. Do not double the dose to||
4222|127|D|catch up.||
4222|128|B|||
4222|129|R|STORAGE:  Store at room temperature with the cap on. Do not||
4222|130|R|refrigerate or freeze. Keep all medications away from children||
4222|131|R|and pets.||
4222|132|R|   Do not flush medications down the toilet or pour them into a||
4222|133|R|drain unless instructed to do so. Properly discard this product||
4222|134|R|when it is expired or no longer needed. Consult your pharmacist||
4222|135|R|or local waste disposal company.||
4222|136|B|||
4222|137|A|Information last revised November 2024.||
4222|138|A|Copyright(c) 2025 First Databank, Inc.||
4222|139|B|||
4235|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4235|002|Z|does NOT have all possible information about this product. This||
4235|003|Z|information does not assure that this product is safe, effective,||
4235|004|Z|or appropriate for you. This information is not individual||
4235|005|Z|medical advice and does not substitute for the advice of your||
4235|006|Z|health care professional. Always ask your health care||
4235|007|Z|professional for complete information about this product and your||
4235|008|Z|specific health needs.||
4235|009|B|||
4235|010|T|CIPROFLOXACIN SUSPENSION - ORAL||
4235|011|F|(SIP-roe-FLOX-a-sin)||
4235|012|B|||
4235|013|C|COMMON BRAND NAME(S): Cipro||
4235|014|B|||
4235|015|W|WARNING:  Quinolone antibiotics (including ciprofloxacin) may||
4235|016|W|cause serious and possibly permanent tendon damage (such as||
4235|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
4235|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
4235|019|W|help right away if you have any of the following symptoms:||
4235|020|W|pain/numbness/burning/tingling/weakness in your||
4235|021|W|arms/hands/legs/feet, changes in how you sense||
4235|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
4235|023|W|headache, vision changes, shaking (tremors), seizures,||
4235|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
4235|025|W|hallucinations, depression, rare thoughts of suicide).||
4235|026|W|   Tendon damage may occur during or after treatment with this||
4235|027|W|medication. Stop exercising, rest, and get medical help right||
4235|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
4235|029|W|risk for tendon problems is greater if you are over 60 years of||
4235|030|W|age, if you are taking corticosteroids (such as prednisone), or||
4235|031|W|if you have a kidney, heart, or lung transplant.||
4235|032|W|   This medication may make a certain muscle condition||
4235|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
4235|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
4235|035|W|unsteady walk) or trouble breathing.||
4235|036|W|   Discuss the risks and benefits with your doctor before using||
4235|037|W|this medication.||
4235|038|B|||
4235|039|U|USES:  This medication is used to treat a variety of bacterial||
4235|040|U|infections. Ciprofloxacin belongs to a class of drugs called||
4235|041|U|quinolone antibiotics. It works by stopping the growth of||
4235|042|U|bacteria.||
4235|043|U|   This antibiotic treats only bacterial infections. It will not||
4235|044|U|work for virus infections (such as common cold, flu). Using any||
4235|045|U|antibiotic when it is not needed can cause it to not work for||
4235|046|U|future infections.||
4235|047|B|||
4235|048|H|HOW TO USE:  Read the Medication Guide and, if available, the||
4235|049|H|Patient Information Leaflet provided by your pharmacist before||
4235|050|H|you start taking ciprofloxacin and each time you get a refill. If||
4235|051|H|you have any questions, ask your doctor or pharmacist.||
4235|052|H|   This medication may be taken with or without food as directed||
4235|053|H|by your doctor, usually twice a day (every 12 hours).||
4235|054|H|   Shake the container well for 15 seconds before pouring each||
4235|055|H|dose. Carefully measure the dose using a special measuring||
4235|056|H|device/spoon. Do not use a household spoon because you may not||
4235|057|H|get the correct dose. Do not chew the contents of the suspension.||
4235|058|H|   Do not use the suspension with feeding tubes because the||
4235|059|H|suspension may clog the tube.||
4235|060|H|   The dosage and length of treatment is based on your medical||
4235|061|H|condition and response to treatment. Drink plenty of fluids while||
4235|062|H|taking this medication unless your doctor tells you otherwise.||
4235|063|H|   Take this medication at least 2 hours before or 6 hours after||
4235|064|H|taking other products that may bind to it, decreasing its||
4235|065|H|effectiveness. Ask your pharmacist about the other products you||
4235|066|H|take. Some examples include: quinapril, sevelamer, sucralfate,||
4235|067|H|vitamins/minerals (including iron and zinc supplements), and||
4235|068|H|products containing magnesium, aluminum, or calcium (such as||
4235|069|H|antacids, calcium supplements).||
4235|070|H|   Calcium-rich foods, including dairy products (such as milk,||
4235|071|H|yogurt) or juice with added calcium, can also decrease the effect||
4235|072|H|of this medication. Take this medication at least 2 hours before||
4235|073|H|or 6 hours after eating calcium-rich foods, unless you are eating||
4235|074|H|these foods as part of a larger meal that contains other||
4235|075|H|(non-calcium-rich) foods. These other foods decrease the calcium||
4235|076|H|binding effect.||
4235|077|H|   Ciprofloxacin may increase and/or prolong the effects of||
4235|078|H|caffeine. Avoid drinking large amounts of beverages containing||
4235|079|H|caffeine (coffee, tea, colas), eating large amounts of chocolate,||
4235|080|H|or taking nonprescription products that contain caffeine.||
4235|081|H|   Ask your doctor or pharmacist about safely using nutritional||
4235|082|H|supplements/replacements with this medication.||
4235|083|H|   For the best effect, take this antibiotic at evenly spaced||
4235|084|H|times. To help you remember, take this medication at the same||
4235|085|H|time(s) every day.||
4235|086|H|   Continue to take this medication until the full prescribed||
4235|087|H|amount is finished, even if symptoms disappear after a few days.||
4235|088|H|Stopping the medication too early may result in a return of the||
4235|089|H|infection.||
4235|090|H|   Tell your doctor if your condition lasts or gets worse.||
4235|091|B|||
4235|092|S|SIDE EFFECTS:  See also Warning section.||
4235|093|S|   Nausea, diarrhea, dizziness, lightheadedness, headache, or||
4235|094|S|trouble sleeping may occur. If any of these effects last or get||
4235|095|S|worse, tell your doctor or pharmacist promptly.||
4235|096|S|   Remember that this medication has been prescribed because your||
4235|097|S|doctor has judged that the benefit to you is greater than the||
4235|098|S|risk of side effects. Many people using this medication do not||
4235|099|S|have serious side effects.||
4235|100|S|   Tell your doctor right away if you have any serious side||
4235|101|S|effects, including: unusual bruising/bleeding, signs of a new||
4235|102|S|infection (such as sore throat that doesn't go away, fever),||
4235|103|S|signs of kidney problems (such as change in the amount of urine,||
4235|104|S|red/pink urine), signs of liver problems (such as nausea/vomiting||
4235|105|S|that doesn't stop, unusual tiredness, stomach/abdominal pain,||
4235|106|S|yellowing eyes/skin, dark urine).||
4235|107|S|   Get medical help right away if you have any very serious side||
4235|108|S|effects, including: severe dizziness, fainting, fast/irregular||
4235|109|S|heartbeat, signs of a tear/break in the main blood vessel called||
4235|110|S|the aorta (such as sudden/severe pain in the stomach/chest/back,||
4235|111|S|shortness of breath).||
4235|112|S|   This medication may rarely cause a severe intestinal condition||
4235|113|S|due to a bacteria called C. difficile. This condition may occur||
4235|114|S|during treatment or weeks to months after treatment has stopped.||
4235|115|S|Tell your doctor right away if you develop: diarrhea that doesn't||
4235|116|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
4235|117|S|stool.||
4235|118|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4235|119|S|products because they may make symptoms worse.||
4235|120|S|   Use of this medication for prolonged or repeated periods may||
4235|121|S|result in oral thrush or a new yeast infection. Contact your||
4235|122|S|doctor if you notice white patches in your mouth, a change in||
4235|123|S|vaginal discharge, or other new symptoms.||
4235|124|S|   A very serious allergic reaction to this drug is rare.||
4235|125|S|However, get medical help right away if you notice any symptoms||
4235|126|S|of a serious allergic reaction, including: rash, itching/swelling||
4235|127|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4235|128|S|breathing.||
4235|129|S|   This is not a complete list of possible side effects. If you||
4235|130|S|notice other effects not listed above, contact your doctor or||
4235|131|S|pharmacist.||
4235|132|S|   In the US -||
4235|133|S|   Call your doctor for medical advice about side effects. You||
4235|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4235|135|S|www.fda.gov/medwatch.||
4235|136|S|   In Canada - Call your doctor for medical advice about side||
4235|137|S|effects. You may report side effects to Health Canada at||
4235|138|S|1-866-234-2345.||
4235|139|B|||
4235|140|P|PRECAUTIONS:  Before taking ciprofloxacin, tell your doctor or||
4235|141|P|pharmacist if you are allergic to it; or to other quinolone||
4235|142|P|antibiotics such as norfloxacin, gemifloxacin, levofloxacin,||
4235|143|P|moxifloxacin, or ofloxacin; or if you have any other allergies.||
4235|144|P|This product may contain inactive ingredients, which can cause||
4235|145|P|allergic reactions or other problems. Talk to your pharmacist for||
4235|146|P|more details.||
4235|147|P|   Before using this medication, tell your doctor or pharmacist||
4235|148|P|your medical history, especially of: diabetes, heart problems||
4235|149|P|(such as recent heart attack), joint/tendon problems (such as||
4235|150|P|tendonitis, bursitis), kidney disease, liver disease, mental/mood||
4235|151|P|disorders (such as depression), myasthenia gravis, nerve problems||
4235|152|P|(such as peripheral neuropathy), seizures, conditions that||
4235|153|P|increase your risk of seizures (such as brain/head injury, brain||
4235|154|P|tumors, cerebral atherosclerosis), blood vessel problems (such as||
4235|155|P|aneurysm or blockage of the aorta or other blood vessels,||
4235|156|P|hardening of the arteries), high blood pressure, certain genetic||
4235|157|P|conditions (Marfan syndrome, Ehlers-Danlos syndrome).||
4235|158|P|   Ciprofloxacin may cause a condition that affects the heart||
4235|159|P|rhythm (QT prolongation). QT prolongation can rarely cause||
4235|160|P|serious (rarely fatal) fast/irregular heartbeat and other||
4235|161|P|symptoms (such as severe dizziness, fainting) that need medical||
4235|162|P|attention right away.||
4235|163|P|   The risk of QT prolongation may be increased if you have||
4235|164|P|certain medical conditions or are taking other drugs that may||
4235|165|P|cause QT prolongation. Before using ciprofloxacin, tell your||
4235|166|P|doctor or pharmacist of all the drugs you take and if you have||
4235|167|P|any of the following conditions: certain heart problems (heart||
4235|168|P|failure, slow heartbeat, QT prolongation in the EKG), family||
4235|169|P|history of certain heart problems (QT prolongation in the EKG,||
4235|170|P|sudden cardiac death).||
4235|171|P|   Low levels of potassium or magnesium in the blood may also||
4235|172|P|increase your risk of QT prolongation. This risk may increase if||
4235|173|P|you use certain drugs (such as diuretics/"water pills") or if you||
4235|174|P|have conditions such as severe sweating, diarrhea, or vomiting.||
4235|175|P|Talk to your doctor about using ciprofloxacin safely.||
4235|176|P|   This medication may rarely cause serious changes in blood||
4235|177|P|sugar, especially if you have diabetes. Check your blood sugar||
4235|178|P|regularly as directed and share the results with your doctor.||
4235|179|P|Watch for symptoms of high blood sugar such as increased||
4235|180|P|thirst/urination. Ciprofloxacin may increase the||
4235|181|P|blood-sugar-lowering effects of the medication glyburide. Also||
4235|182|P|watch for symptoms of low blood sugar such as sudden sweating,||
4235|183|P|shaking, fast heartbeat, hunger, blurred vision, dizziness, or||
4235|184|P|tingling hands/feet. It is a good habit to carry glucose tablets||
4235|185|P|or gel to treat low blood sugar. If you don't have these reliable||
4235|186|P|forms of glucose, rapidly raise your blood sugar by eating a||
4235|187|P|quick source of sugar such as table sugar, honey, or candy, or by||
4235|188|P|drinking fruit juice or non- diet soda. Tell your doctor right||
4235|189|P|away about the reaction and the use of this product. To help||
4235|190|P|prevent low blood sugar, eat meals on a regular schedule, and do||
4235|191|P|not skip meals. Your doctor may need to switch you to another||
4235|192|P|antibiotic or adjust your diabetes medications if any reaction||
4235|193|P|occurs.||
4235|194|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4235|195|P|can make you more dizzy. Do not drive, use machinery, or do||
4235|196|P|anything that needs alertness until you can do it safely. Limit||
4235|197|P|alcoholic beverages. Talk to your doctor if you are using||
4235|198|P|marijuana (cannabis).||
4235|199|P|   This medication may make you more sensitive to the sun. Limit||
4235|200|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4235|201|P|sunscreen and wear protective clothing when outdoors. Tell your||
4235|202|P|doctor right away if you get sunburned or have skin||
4235|203|P|blisters/redness.||
4235|204|P|   Ciprofloxacin may cause live bacterial vaccines (such as||
4235|205|P|typhoid vaccine) to not work well. Tell your health care||
4235|206|P|professional that you are using ciprofloxacin before having any||
4235|207|P|immunizations/vaccinations.||
4235|208|P|   Before having surgery, tell your doctor or dentist about all||
4235|209|P|the products you use (including prescription drugs,||
4235|210|P|nonprescription drugs, and herbal products).||
4235|211|P|   This medication contains sucrose. It is not recommended if you||
4235|212|P|have a rare hereditary metabolic condition (such as fructose||
4235|213|P|intolerance, sucrase-isomaltase deficiency, glucose-galactose||
4235|214|P|malabsorption).||
4235|215|P|   Children may be more sensitive to the side effects of this||
4235|216|P|drug, especially joint/tendon problems.||
4235|217|P|   Older adults may be at greater risk for tendon problems||
4235|218|P|(especially if they are also taking corticosteroids such as||
4235|219|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
4235|220|P|tear/break in the main blood vessel (aorta).||
4235|221|P|   During pregnancy, this medication should be used only when||
4235|222|P|clearly needed. Discuss the risks and benefits with your doctor.||
4235|223|P|   This medication passes into breast milk and may have||
4235|224|P|undesirable effects on a nursing infant. Consult your doctor||
4235|225|P|before breastfeeding.||
4235|226|B|||
4235|227|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
4235|228|I|   Drug interactions may change how your medications work or||
4235|229|I|increase your risk for serious side effects. This document does||
4235|230|I|not contain all possible drug interactions. Keep a list of all||
4235|231|I|the products you use (including prescription/nonprescription||
4235|232|I|drugs and herbal products) and share it with your doctor and||
4235|233|I|pharmacist. Do not start, stop, or change the dosage of any||
4235|234|I|medicines without your doctor's approval.||
4235|235|I|   Some products that may interact with this drug include: "blood||
4235|236|I|thinners" (such as acenocoumarol, warfarin), strontium.||
4235|237|I|   Many drugs besides ciprofloxacin may affect the heart rhythm||
4235|238|I|(QT prolongation), including amiodarone, dofetilide, quinidine,||
4235|239|I|procainamide, sotalol, among others.||
4235|240|I|   This medication can slow down the removal of other medications||
4235|241|I|from your body, which may affect how they work. Examples of||
4235|242|I|affected drugs include duloxetine, fezolinetant, pirfenidone,||
4235|243|I|tasimelteon, tizanidine, vorasidenib, among others.||
4235|244|B|||
4235|245|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4235|246|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4235|247|O|poison control center right away. US residents can call||
4235|248|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4235|249|B|||
4235|250|N|NOTES:  Do not share this medication with others.||
4235|251|N|   This medication has been prescribed for your current condition||
4235|252|N|only. Do not use it later for another infection unless your||
4235|253|N|doctor tells you to.||
4235|254|N|   Lab and/or medical tests (such as kidney function, blood||
4235|255|N|counts, cultures) should be done while you are taking this||
4235|256|N|medication. Keep all medical and lab appointments. Consult your||
4235|257|N|doctor for more details.||
4235|258|N|   Do not change brands of this medication without asking your||
4235|259|N|doctor or pharmacist. Not all brands have the same effects.||
4235|260|B|||
4235|261|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4235|262|D|remember. If it is less than 6 hours before the next dose, skip||
4235|263|D|the missed dose. Take your next dose at the regular time. Do not||
4235|264|D|double the dose to catch up.||
4235|265|B|||
4235|266|R|STORAGE:  Store upright in the refrigerator or at room||
4235|267|R|temperature. Do not freeze. Discard any unused portion after 14||
4235|268|R|days. Keep all medications away from children and pets.||
4235|269|R|   Do not flush medications down the toilet or pour them into a||
4235|270|R|drain unless instructed to do so. Properly discard this product||
4235|271|R|when it is expired or no longer needed. Consult your pharmacist||
4235|272|R|or local waste disposal company.||
4235|273|B|||
4235|274|A|Information last revised September 2025.||
4235|275|A|Copyright(c) 2025 First Databank, Inc.||
4235|276|B|||
4241|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4241|002|Z|does NOT have all possible information about this product. This||
4241|003|Z|information does not assure that this product is safe, effective,||
4241|004|Z|or appropriate for you. This information is not individual||
4241|005|Z|medical advice and does not substitute for the advice of your||
4241|006|Z|health care professional. Always ask your health care||
4241|007|Z|professional for complete information about this product and your||
4241|008|Z|specific health needs.||
4241|009|B|||
4241|010|T|IBUPROFEN 40 MG/ML DROPS - ORAL||
4241|011|F|(EYE-bue-PROE-fen)||
4241|012|B|||
4241|013|C|COMMON BRAND NAME(S): Motrin||
4241|014|B|||
4241|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
4241|016|W|ibuprofen) may rarely increase the risk for a heart attack or||
4241|017|W|stroke. This effect can happen at any time while taking this drug||
4241|018|W|but is more likely if you take it for a long time. The risk may||
4241|019|W|be greater in older adults or if you have heart disease or||
4241|020|W|increased risk for heart disease (for example, due to smoking,||
4241|021|W|family history of heart disease, or conditions such as high blood||
4241|022|W|pressure or diabetes). Do not take this drug right before or||
4241|023|W|after heart bypass surgery (CABG).||
4241|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
4241|025|W|from the stomach or intestines. This effect can occur without||
4241|026|W|warning at any time while taking this drug. Older adults may be||
4241|027|W|at higher risk for this effect.||
4241|028|W|   Stop taking ibuprofen and get medical help right away if you||
4241|029|W|notice any of these rare but serious side effects:||
4241|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
4241|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
4241|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
4241|033|W|side of the body, trouble speaking, sudden vision changes.||
4241|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
4241|035|W|of taking this drug.||
4241|036|B|||
4241|037|U|USES:  Ibuprofen is used to relieve pain from various conditions||
4241|038|U|such as headache, dental pain, menstrual cramps, muscle aches, or||
4241|039|U|arthritis. It is also used to reduce fever and to relieve minor||
4241|040|U|aches and pain due to the common cold or flu. Ibuprofen is a||
4241|041|U|nonsteroidal anti-inflammatory drug (NSAID). It works by blocking||
4241|042|U|your body's production of certain natural substances that cause||
4241|043|U|inflammation. This effect helps to decrease swelling, pain, or||
4241|044|U|fever.||
4241|045|U|   If you are treating a chronic condition such as arthritis, ask||
4241|046|U|your doctor about non-drug treatments and/or using other||
4241|047|U|medications to treat your pain. See also Warning section.||
4241|048|U|   This form of ibuprofen is intended for use by children. Do not||
4241|049|U|give this medication to a child younger than 6 months unless||
4241|050|U|directed by the doctor.||
4241|051|U|   Check the ingredients on the label even if you have used the||
4241|052|U|product before. The manufacturer may have changed the||
4241|053|U|ingredients. Also, products with similar names may contain||
4241|054|U|different ingredients meant for different purposes. Taking the||
4241|055|U|wrong product could harm you.||
4241|056|B|||
4241|057|H|HOW TO USE:  Read and follow all directions on the product||
4241|058|H|package before using this medication. If you have any questions,||
4241|059|H|ask your doctor or pharmacist.||
4241|060|H|   Take this medication by mouth as directed by your doctor or||
4241|061|H|the package label, usually every 6 to 8 hours as needed. Shake||
4241|062|H|the bottle well before each dose. Carefully measure the dose||
4241|063|H|using the provided dropper/syringe. Do not use a household spoon||
4241|064|H|because you may not get the correct dose. If you have stomach||
4241|065|H|upset while taking this medication, take it with food or milk.||
4241|066|H|   The dosage is based on your medical condition and response to||
4241|067|H|treatment. To reduce your risk of stomach bleeding and other side||
4241|068|H|effects, take this medication at the lowest effective dose for||
4241|069|H|the shortest possible time. Do not increase your dose or take||
4241|070|H|this drug more often than directed by your doctor or the package||
4241|071|H|label.||
4241|072|H|   Children's dosage is based on weight. Read the package||
4241|073|H|directions to find the proper dose for your child's weight.||
4241|074|H|Consult the pharmacist or doctor if you have questions or if you||
4241|075|H|need help choosing a nonprescription product.||
4241|076|H|   If you are using this drug "as needed" (not on a regular||
4241|077|H|schedule), remember that pain medications work best if they are||
4241|078|H|used as the first signs of pain occur. If you wait until the pain||
4241|079|H|has worsened, the medication may not work as well.||
4241|080|H|   If your condition lasts or gets worse, or if you think you may||
4241|081|H|have a serious medical problem, get medical help right away. If||
4241|082|H|you are using the nonprescription product to treat yourself or a||
4241|083|H|child for fever or pain, consult the doctor right away if fever||
4241|084|H|gets worse or lasts more than 3 days, or if pain gets worse or||
4241|085|H|lasts more than 10 days.||
4241|086|B|||
4241|087|S|SIDE EFFECTS:  See also Warning section.||
4241|088|S|   Upset stomach, nausea, vomiting, headache, diarrhea,||
4241|089|S|constipation, dizziness, or drowsiness may occur. If any of these||
4241|090|S|effects last or get worse, tell your doctor or pharmacist||
4241|091|S|promptly.||
4241|092|S|   If your doctor has directed you to use this medication,||
4241|093|S|remember that your doctor has judged that the benefit to you is||
4241|094|S|greater than the risk of side effects. Many people using this||
4241|095|S|medication do not have serious side effects.||
4241|096|S|   This medication may raise your blood pressure. Check your||
4241|097|S|blood pressure regularly and tell your doctor if the results are||
4241|098|S|high.||
4241|099|S|   Tell your doctor right away if you have any serious side||
4241|100|S|effects, including: easy bruising/bleeding, hearing changes (such||
4241|101|S|as ringing in the ears), mental/mood changes, unexplained stiff||
4241|102|S|neck, signs of kidney problems (such as change in the amount of||
4241|103|S|urine), vision changes, symptoms of heart failure (such as||
4241|104|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
4241|105|S|gain).||
4241|106|S|   This drug may rarely cause serious (possibly fatal) liver||
4241|107|S|disease. Get medical help right away if you have any symptoms of||
4241|108|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
4241|109|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
4241|110|S|eyes/skin.||
4241|111|S|   A very serious allergic reaction to this drug is rare.||
4241|112|S|However, get medical help right away if you notice any symptoms||
4241|113|S|of a serious allergic reaction, including: fever, swollen lymph||
4241|114|S|nodes, rash, itching/swelling (especially of the||
4241|115|S|face/tongue/throat), severe dizziness, trouble breathing.||
4241|116|S|   This is not a complete list of possible side effects. If you||
4241|117|S|notice other effects not listed above, contact your doctor or||
4241|118|S|pharmacist.||
4241|119|S|   In the US -||
4241|120|S|   Call your doctor for medical advice about side effects. You||
4241|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4241|122|S|www.fda.gov/medwatch.||
4241|123|S|   In Canada - Call your doctor for medical advice about side||
4241|124|S|effects. You may report side effects to Health Canada at||
4241|125|S|1-866-234-2345.||
4241|126|B|||
4241|127|P|PRECAUTIONS:  Before using ibuprofen, tell the doctor or||
4241|128|P|pharmacist if you are allergic to it; or to aspirin or other||
4241|129|P|NSAIDs (such as naproxen, celecoxib); or if you have any other||
4241|130|P|allergies. This product may contain inactive ingredients, which||
4241|131|P|can cause allergic reactions or other problems. Talk to your||
4241|132|P|pharmacist for more details.||
4241|133|P|   Before using this medication, tell your doctor or pharmacist||
4241|134|P|your medical history, especially of: asthma (including a history||
4241|135|P|of worsening breathing after taking aspirin or other NSAIDs),||
4241|136|P|blood disorders (such as anemia, bleeding/clotting problems),||
4241|137|P|growths in the nose (nasal polyps), heart disease (such as||
4241|138|P|previous heart attack), high blood pressure, liver disease,||
4241|139|P|stroke, throat/stomach/intestinal problems (such as bleeding,||
4241|140|P|heartburn, ulcers).||
4241|141|P|   Kidney problems can sometimes occur with the use of NSAID||
4241|142|P|medications, including ibuprofen. Problems are more likely to||
4241|143|P|occur if you are dehydrated, have heart failure or kidney||
4241|144|P|disease, are an older adult, or if you take certain medications||
4241|145|P|(see also Drug Interactions section). Drink plenty of fluids as||
4241|146|P|directed by your doctor to prevent dehydration and tell your||
4241|147|P|doctor right away if you have a change in the amount of urine.||
4241|148|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4241|149|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4241|150|P|machinery, or do anything that needs alertness until you can do||
4241|151|P|it safely. Talk to your doctor if you are using marijuana||
4241|152|P|(cannabis).||
4241|153|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
4241|154|P|and tobacco, especially when combined with this medicine, may||
4241|155|P|increase your risk for stomach bleeding. Limit alcohol and stop||
4241|156|P|smoking. Consult your doctor or pharmacist for more information.||
4241|157|P|   This medication may make you more sensitive to the sun. Limit||
4241|158|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4241|159|P|sunscreen and wear protective clothing when outdoors. Tell your||
4241|160|P|doctor right away if you get sunburned or have skin||
4241|161|P|blisters/redness.||
4241|162|P|   This product may contain sugar and/or aspartame. Caution is||
4241|163|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
4241|164|P|condition that requires you to limit/avoid these substances in||
4241|165|P|your diet. Ask your doctor or pharmacist about using this product||
4241|166|P|safely.||
4241|167|P|   Before having surgery, tell your doctor or dentist about all||
4241|168|P|the products you use (including prescription drugs,||
4241|169|P|nonprescription drugs, and herbal products).||
4241|170|P|   Older adults may be at greater risk for stomach/intestinal||
4241|171|P|bleeding, kidney problems, heart attack, and stroke while using||
4241|172|P|this drug.||
4241|173|P|   Before using this medication, women of childbearing age should||
4241|174|P|talk with their doctor(s) about the benefits and risks. Tell your||
4241|175|P|doctor if you are pregnant or if you plan to become pregnant.||
4241|176|P|This medication may harm an unborn baby and cause problems with||
4241|177|P|normal labor/delivery. It is not recommended for use in pregnancy||
4241|178|P|from 20 weeks until delivery. If your doctor decides that you||
4241|179|P|need to use this medication between 20 and 30 weeks of pregnancy,||
4241|180|P|you should use the lowest effective dose for the shortest||
4241|181|P|possible time. You should not use this medication after 30 weeks||
4241|182|P|of pregnancy.||
4241|183|P|   This medication passes into breast milk, but is unlikely to||
4241|184|P|harm a nursing infant. Consult your doctor before breastfeeding.||
4241|185|B|||
4241|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4241|187|I|medications work or increase your risk for serious side effects.||
4241|188|I|This document does not contain all possible drug interactions.||
4241|189|I|Keep a list of all the products you use (including||
4241|190|I|prescription/nonprescription drugs and herbal products) and share||
4241|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
4241|192|I|the dosage of any medicines without your doctor's approval.||
4241|193|I|   Some products that may interact with this drug include:||
4241|194|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
4241|195|I|angiotensin II receptor blockers (such as valsartan, losartan),||
4241|196|I|cidofovir, corticosteroids (such as prednisone), lithium, "water||
4241|197|I|pills" (diuretics such as furosemide).||
4241|198|I|   This medication may increase the risk of bleeding when taken||
4241|199|I|with other drugs that also may cause bleeding. Examples include||
4241|200|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
4241|201|I|dabigatran/enoxaparin/warfarin, among others.||
4241|202|I|   Check all prescription and nonprescription medicine labels||
4241|203|I|carefully since many medications contain pain relievers/fever||
4241|204|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
4241|205|I|or naproxen). These drugs are similar to ibuprofen and may||
4241|206|I|increase your risk of side effects if taken together. However, if||
4241|207|I|your doctor has told you to take low-dose aspirin to prevent||
4241|208|I|heart attack or stroke (usually 81-162 milligrams a day), you||
4241|209|I|should keep taking the aspirin unless your doctor tells you not||
4241|210|I|to. Daily use of ibuprofen may decrease aspirin's ability to||
4241|211|I|prevent heart attack/stroke. Talk to your doctor about using a||
4241|212|I|different medication (such as acetaminophen) to treat pain/fever.||
4241|213|I|If you must take ibuprofen, talk to your doctor about taking||
4241|214|I|immediate-release aspirin (not enteric-coated/EC) while taking||
4241|215|I|ibuprofen. Take ibuprofen at least 8 hours before or at least 2||
4241|216|I|hours after your aspirin dose. Do not increase your daily dose of||
4241|217|I|aspirin or change the way you take aspirin/other medications||
4241|218|I|without your doctor's approval.||
4241|219|B|||
4241|220|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4241|221|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4241|222|O|poison control center right away. US residents can call||
4241|223|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4241|224|O|Symptoms of overdose may include: severe stomach pain, trouble||
4241|225|O|breathing, extreme drowsiness.||
4241|226|B|||
4241|227|N|NOTES:  Lab and/or medical tests (such as blood pressure, kidney||
4241|228|N|function) may be done while you are taking this medication. Keep||
4241|229|N|all medical and lab appointments. Consult your doctor for more||
4241|230|N|details.||
4241|231|B|||
4241|232|D|MISSED DOSE:  If you are using this drug on a regular schedule||
4241|233|D|(not just "as needed") and you miss a dose, take it as soon as||
4241|234|D|you remember. If it is near the time of the next dose, skip the||
4241|235|D|missed dose. Take your next dose at the regular time. Do not||
4241|236|D|double the dose to catch up.||
4241|237|B|||
4241|238|R|STORAGE:  Store at room temperature away from light and moisture.||
4241|239|R|Do not store in the bathroom. Keep all medications away from||
4241|240|R|children and pets.||
4241|241|R|   Do not flush medications down the toilet or pour them into a||
4241|242|R|drain unless instructed to do so. Properly discard this product||
4241|243|R|when it is expired or no longer needed. Consult your pharmacist||
4241|244|R|or local waste disposal company.||
4241|245|B|||
4241|246|A|Information last revised August 2024.||
4241|247|A|Copyright(c) 2025 First Databank, Inc.||
4241|248|B|||
4244|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4244|002|Z|does NOT have all possible information about this product. This||
4244|003|Z|information does not assure that this product is safe, effective,||
4244|004|Z|or appropriate for you. This information is not individual||
4244|005|Z|medical advice and does not substitute for the advice of your||
4244|006|Z|health care professional. Always ask your health care||
4244|007|Z|professional for complete information about this product and your||
4244|008|Z|specific health needs.||
4244|009|B|||
4244|010|T|DIAZEPAM - RECTAL||
4244|011|F|(dye-AZ-e-pam)||
4244|012|B|||
4244|013|C|COMMON BRAND NAME(S): Diastat||
4244|014|B|||
4244|015|W|WARNING:  Diazepam has a risk for abuse and addiction, which can||
4244|016|W|lead to overdose and death. Using this medication with alcohol or||
4244|017|W|other drugs that can cause drowsiness or breathing problems||
4244|018|W|(especially opioid medications such as codeine, hydrocodone) may||
4244|019|W|cause very serious side effects, including death. To lower your||
4244|020|W|risk, your doctor should have you use the smallest dose of||
4244|021|W|diazepam that works, and use it for the shortest possible time.||
4244|022|W|Be sure you know how to use diazepam and what other drugs you||
4244|023|W|should avoid taking with it. See also Drug Interactions section.||
4244|024|W|Get medical help right away if any of these very serious side||
4244|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
4244|026|W|severe drowsiness/dizziness, difficulty waking up.||
4244|027|W|   This medication should not be used regularly. If you use it||
4244|028|W|regularly, suddenly stopping this medication may cause serious||
4244|029|W|(possibly fatal) withdrawal, especially if you have used it for a||
4244|030|W|long time or in high doses. To prevent withdrawal, your doctor||
4244|031|W|may lower your dose slowly. Tell your doctor or pharmacist right||
4244|032|W|away if you have any withdrawal symptoms such as headaches,||
4244|033|W|trouble sleeping, restlessness, hallucinations/confusion,||
4244|034|W|depression, nausea, or seizures. Withdrawal symptoms may||
4244|035|W|sometimes last weeks to months.||
4244|036|B|||
4244|037|U|USES:  This medication is used to treat episodes of increased||
4244|038|U|seizures (such as cluster or breakthrough seizures) in people who||
4244|039|U|are already taking medications to control their seizures. This||
4244|040|U|product is only recommended for short-term treatment of seizure||
4244|041|U|attacks. It is not for ongoing daily use to prevent seizures.||
4244|042|U|Uncontrolled seizures can turn into serious (possibly fatal)||
4244|043|U|seizures that do not stop (status epilepticus).||
4244|044|U|   This medication is not recommended for children younger than 6||
4244|045|U|months of age because of the risk of serious side effects.||
4244|046|U|   Diazepam works by calming the brain and nerves. It belongs to||
4244|047|U|a class of drugs known as benzodiazepines.||
4244|048|B|||
4244|049|H|HOW TO USE:  See also Warning section.||
4244|050|H|   Read the Patient/Caregiver Information Leaflet if available||
4244|051|H|from your pharmacist before you start using this product and each||
4244|052|H|time you get a refill. If you have any questions, ask your doctor||
4244|053|H|or pharmacist.||
4244|054|H|   This drug is given rectally by a caregiver trained to||
4244|055|H|recognize the difference between your cluster and ordinary||
4244|056|H|seizures. You and your caregiver must be comfortable with||
4244|057|H|following all instructions from your doctor, pharmacist, and the||
4244|058|H|product package. Be sure you understand when this medication||
4244|059|H|should be used, how to use it, and how to check for side||
4244|060|H|effects/seizure control.||
4244|061|H|   Before using, check the syringe for the correct dose. For some||
4244|062|H|brands, your pharmacist should set the correct dose and lock the||
4244|063|H|syringe in the "ready" position before giving you the product.||
4244|064|H|For those brands, check to see if the correct dose is in the||
4244|065|H|display window and the word "ready" is at the bottom of the||
4244|066|H|syringe barrel. Also, for all products, look to make sure you||
4244|067|H|have the correct syringe tip (for example, a smaller tip for a||
4244|068|H|child) and that there are no cracks around the syringe tip.||
4244|069|H|Return the product to the pharmacist if there is a problem or if||
4244|070|H|you have any questions.||
4244|071|H|   Cracks can cause the medication to leak out and not provide||
4244|072|H|the correct amount of medication. If you see a crack, use a||
4244|073|H|different syringe. Cracks can appear over time, so keep checking||
4244|074|H|your syringes to make sure you have good ones ready to use.||
4244|075|H|   The dosage is based on age, weight, medical condition, and||
4244|076|H|response to treatment. In some cases, a second dose may be||
4244|077|H|prescribed and given 4 to 12 hours after the first dose. Usually,||
4244|078|H|this medication should not be used to treat more than 5 episodes||
4244|079|H|per month and no more than one episode every 5 days. Do not stop||
4244|080|H|taking your regular seizure control medications when you are||
4244|081|H|given this drug.||
4244|082|H|   Though it helps many people, this medication may sometimes||
4244|083|H|cause addiction. This risk may be higher if you have a substance||
4244|084|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
4244|085|H|Take this medication exactly as prescribed to lower the risk of||
4244|086|H|addiction. Ask your doctor or pharmacist for more details.||
4244|087|H|   Get emergency help right away if seizures continue after using||
4244|088|H|this product (for example, no change 15 minutes after the dose is||
4244|089|H|given), or if there is a change in the person's breathing,||
4244|090|H|coloring, behavior, or condition that alarms you.||
4244|091|B|||
4244|092|S|SIDE EFFECTS:  See also Warning section.||
4244|093|S|   Drowsiness, dizziness, or unsteadiness may occur. If any of||
4244|094|S|these effects last or get worse, tell your doctor or pharmacist||
4244|095|S|promptly.||
4244|096|S|   Remember that this medication has been prescribed because your||
4244|097|S|doctor has judged that the benefit to you is greater than the||
4244|098|S|risk of side effects. Many people using this medication do not||
4244|099|S|have serious side effects. Stay with the patient for at least 4||
4244|100|S|hours after giving the medication and watch for any side effects.||
4244|101|S|   Tell your doctor right away if you have any serious side||
4244|102|S|effects, including: mental/mood changes (such as anxiety,||
4244|103|S|restlessness, hallucinations), trouble speaking, trouble walking.||
4244|104|S|   Get medical help right away if you have any very serious side||
4244|105|S|effects, including: slow/shallow breathing.||
4244|106|S|   A very serious allergic reaction to this drug is rare.||
4244|107|S|However, get medical help right away if you notice any symptoms||
4244|108|S|of a serious allergic reaction, including: rash, itching/swelling||
4244|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4244|110|S|breathing.||
4244|111|S|   This is not a complete list of possible side effects. If you||
4244|112|S|notice other effects not listed above, contact your doctor or||
4244|113|S|pharmacist.||
4244|114|S|   In the US -||
4244|115|S|   Call your doctor for medical advice about side effects. You||
4244|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4244|117|S|www.fda.gov/medwatch.||
4244|118|S|   In Canada - Call your doctor for medical advice about side||
4244|119|S|effects. You may report side effects to Health Canada at||
4244|120|S|1-866-234-2345.||
4244|121|B|||
4244|122|P|PRECAUTIONS:  Before using diazepam, tell your doctor or||
4244|123|P|pharmacist if you are allergic to it; or to other benzodiazepines||
4244|124|P|(such as oxazepam, temazepam); or if you have any other||
4244|125|P|allergies. This product may contain inactive ingredients, which||
4244|126|P|can cause allergic reactions or other problems. Talk to your||
4244|127|P|pharmacist for more details.||
4244|128|P|   Before using this medication, tell your doctor or pharmacist||
4244|129|P|your medical history, especially of: a certain muscle disease||
4244|130|P|(myasthenia gravis), lung/breathing problems (such as asthma,||
4244|131|P|pneumonia, COPD, sleep apnea), mental/mood disorders (such as||
4244|132|P|depression, thoughts of suicide, psychosis), personal or family||
4244|133|P|history of a substance use disorder (such as overuse of or||
4244|134|P|addiction to drugs/alcohol), glaucoma, brain problems that could||
4244|135|P|affect breathing (such as decreased consciousness, head injury),||
4244|136|P|kidney disease, liver disease.||
4244|137|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4244|138|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4244|139|P|machinery, ride a bicycle, or do anything that needs alertness||
4244|140|P|until you can do it safely. Avoid alcoholic beverages. Talk to||
4244|141|P|your doctor if you are using marijuana (cannabis).||
4244|142|P|   Before having surgery, tell your doctor or dentist about all||
4244|143|P|the products you use (including prescription drugs,||
4244|144|P|nonprescription drugs, and herbal products).||
4244|145|P|   Older adults may be more sensitive to the side effects of this||
4244|146|P|drug, especially drowsiness and loss of coordination. These side||
4244|147|P|effects can increase the risk of falling.||
4244|148|P|   During pregnancy, this medication should be used only when||
4244|149|P|clearly needed. It may harm an unborn baby. Newborn babies of||
4244|150|P|mothers who use this medication late in pregnancy may have||
4244|151|P|symptoms such as slow/shallow breathing, nonstop crying, shaking,||
4244|152|P|or trouble feeding. However, since untreated seizures are a||
4244|153|P|serious condition that can harm both a pregnant woman and her||
4244|154|P|unborn baby, do not stop using this medication unless directed by||
4244|155|P|your doctor. If you are planning pregnancy, become pregnant, or||
4244|156|P|think you may be pregnant, talk to your doctor right away about||
4244|157|P|the risks and benefits of this medication.||
4244|158|P|   This drug passes into breast milk and may have undesirable||
4244|159|P|effects on a nursing infant. Consult your doctor before||
4244|160|P|breastfeeding.||
4244|161|B|||
4244|162|I|DRUG INTERACTIONS:  See also Warning section.||
4244|163|I|   Drug interactions may change how your medications work or||
4244|164|I|increase your risk for serious side effects. This document does||
4244|165|I|not contain all possible drug interactions. Keep a list of all||
4244|166|I|the products you use (including prescription/nonprescription||
4244|167|I|drugs and herbal products) and share it with your doctor and||
4244|168|I|pharmacist. Do not start, stop, or change the dosage of any||
4244|169|I|medicines without your doctor's approval.||
4244|170|I|   Some products that may interact with this drug include:||
4244|171|I|clozapine, fluvoxamine, sodium oxybate.||
4244|172|I|   The risk of serious side effects (such as slow/shallow||
4244|173|I|breathing, severe drowsiness/dizziness) may be increased if this||
4244|174|I|medication is used with other products that may also cause||
4244|175|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
4244|176|I|if you are taking other products such as opioid pain or cough||
4244|177|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4244|178|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4244|179|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4244|180|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
4244|181|I|diphenhydramine).||
4244|182|I|   Check the labels on all your medicines (such as allergy or||
4244|183|I|cough-and-cold products) because they may contain ingredients||
4244|184|I|that cause drowsiness. Ask your pharmacist about using those||
4244|185|I|products safely.||
4244|186|B|||
4244|187|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
4244|188|O|has overdosed and has serious symptoms such as passing out or||
4244|189|O|trouble breathing, call 911. Otherwise, call a poison control||
4244|190|O|center right away. US residents can call 1-800-222-1222. Canada||
4244|191|O|residents can call 1-844-764-7669. Symptoms of overdose may||
4244|192|O|include: severe drowsiness, confusion, slow reflexes,||
4244|193|O|slow/shallow breathing, fainting, loss of consciousness.||
4244|194|B|||
4244|195|N|NOTES:  Do not share this medication with others. Sharing it is||
4244|196|N|against the law.||
4244|197|B|||
4244|198|D|MISSED DOSE:  Not applicable.||
4244|199|B|||
4244|200|R|STORAGE:  Store at room temperature. Keep all medications away||
4244|201|R|from children and pets.||
4244|202|R|   Do not flush medications down the toilet or pour them into a||
4244|203|R|drain unless instructed to do so. Properly discard this product||
4244|204|R|when it is expired or no longer needed. For more details, read||
4244|205|R|the Patient/Caregiver Information Leaflet, or consult your||
4244|206|R|pharmacist or local waste disposal company.||
4244|207|B|||
4244|208|M|MEDICAL ALERT:  Your condition can cause complications in a||
4244|209|M|medical emergency. For information about enrolling in MedicAlert,||
4244|210|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4244|211|B|||
4244|212|A|Information last revised January 2025.||
4244|213|A|Copyright(c) 2025 First Databank, Inc.||
4244|214|B|||
4247|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4247|002|Z|does NOT have all possible information about this product. This||
4247|003|Z|information does not assure that this product is safe, effective,||
4247|004|Z|or appropriate for you. This information is not individual||
4247|005|Z|medical advice and does not substitute for the advice of your||
4247|006|Z|health care professional. Always ask your health care||
4247|007|Z|professional for complete information about this product and your||
4247|008|Z|specific health needs.||
4247|009|B|||
4247|010|T|SALMETEROL DISK INHALER - ORAL INHALATION||
4247|011|F|(sal-MET-er-all)||
4247|012|B|||
4247|013|C|COMMON BRAND NAME(S): Serevent Diskus||
4247|014|B|||
4247|015|W|WARNING:  Rarely, when treating asthma, serious (sometimes fatal)||
4247|016|W|asthma-related breathing problems have occurred with the use of||
4247|017|W|long-acting inhaled beta agonists (such as salmeterol). In||
4247|018|W|patients with asthma, this drug should only be prescribed when||
4247|019|W|one long-term medication (such as inhaled corticosteroids) does||
4247|020|W|not control breathing problems or when more than one long-term||
4247|021|W|medication is clearly needed to control breathing problems.||
4247|022|W|Salmeterol must not be used alone to treat asthma. Before using||
4247|023|W|this medication, it is important to learn how to use it properly.||
4247|024|W|Discuss the risks and benefits of treatment with this medication||
4247|025|W|with your doctor.||
4247|026|W|   Once asthma symptoms are controlled, if possible, your doctor||
4247|027|W|may stop treatment with salmeterol and continue only your other||
4247|028|W|asthma medications (such as inhaled corticosteroids). Follow your||
4247|029|W|doctor's directions carefully.||
4247|030|B|||
4247|031|U|USES:  Salmeterol is used as a long-term (maintenance) treatment||
4247|032|U|to prevent or decrease wheezing and trouble breathing caused by||
4247|033|U|asthma or ongoing lung disease (chronic obstructive pulmonary||
4247|034|U|disease-COPD, which includes chronic bronchitis and emphysema).||
4247|035|U|It should only be used long-term if your asthma symptoms are not||
4247|036|U|controlled by your other asthma medications (such as inhaled||
4247|037|U|corticosteroids). Salmeterol must not be used alone to treat||
4247|038|U|asthma. (See also Warning section.) It is also used to prevent||
4247|039|U|asthma brought on by exercise (bronchospasm). Salmeterol works by||
4247|040|U|relaxing the muscles around the airways so that they open up and||
4247|041|U|you can breathe more easily. Controlling symptoms of breathing||
4247|042|U|problems can decrease time lost from work or school.||
4247|043|U|   This medication does not work right away and should not be||
4247|044|U|used for sudden attacks of breathing trouble. Your doctor must||
4247|045|U|prescribe a quick-relief medicine/inhaler (such as albuterol) for||
4247|046|U|sudden shortness of breath/asthma attacks while you are on this||
4247|047|U|medication. You should always have a quick-relief inhaler with||
4247|048|U|you. Consult your doctor or pharmacist for more details.||
4247|049|U|   This medication should be used in combination with other||
4247|050|U|medications such as long-acting inhaled corticosteroids. However,||
4247|051|U|it should not be used with other long-acting inhaled beta||
4247|052|U|agonists (such as formoterol, combination salmeterol/fluticasone)||
4247|053|U|since this may increase your risk for side effects.||
4247|054|U|   It is recommended that children and teenagers, who need to use||
4247|055|U|salmeterol to treat their asthma, should use a combination||
4247|056|U|salmeterol/fluticasone product. Check with your child's doctor to||
4247|057|U|see if this product is the right product for your child.||
4247|058|U|   In patients with asthma, this medication should not be used||
4247|059|U|when breathing problems can be controlled with inhaled||
4247|060|U|corticosteroids (such as flunisolide, fluticasone) and occasional||
4247|061|U|use of quick-relief inhalers. (See also Warning section.)||
4247|062|U|   If you are regularly taking corticosteroids by mouth (such as||
4247|063|U|prednisone), you should not stop using them or use this inhaled||
4247|064|U|medication instead. Continue to follow your doctor's instructions||
4247|065|U|for taking the corticosteroids by mouth.||
4247|066|B|||
4247|067|H|HOW TO USE:  Read the Medication Guide provided by your||
4247|068|H|pharmacist before you start using salmeterol and each time you||
4247|069|H|get a refill. Follow the illustrated directions for the proper||
4247|070|H|use of this medication. If you have any questions, ask your||
4247|071|H|doctor or pharmacist.||
4247|072|H|   Always activate and use this device in a level, horizontal||
4247|073|H|position.||
4247|074|H|   Inhale this medication by mouth as directed by your doctor,||
4247|075|H|usually twice daily (in the morning and evening, 12 hours apart).||
4247|076|H|You may or may not taste/feel the drug when you inhale. Either is||
4247|077|H|normal. Never exhale into the device. Do not use with a spacer.||
4247|078|H|Never wash the mouthpiece or any part of the device.||
4247|079|H|   If you are using other inhalers at the same time, wait at||
4247|080|H|least 1 minute between the use of each medication.||
4247|081|H|   The dosage is based on your medical condition and response to||
4247|082|H|treatment. Use this medication regularly to receive the most||
4247|083|H|benefit from it. To help you remember, use it at the same times||
4247|084|H|each day. Do not use it more often than prescribed or use more||
4247|085|H|than 1 inhalation twice daily since this may increase the risk of||
4247|086|H|side effects.||
4247|087|H|   Do not stop taking this medication or change your dose without||
4247|088|H|consulting your doctor. Some conditions may become worse when the||
4247|089|H|drug is suddenly stopped. Your dose may need to be gradually||
4247|090|H|decreased.||
4247|091|H|   If you have been using a quick-relief inhaler on a regular||
4247|092|H|daily schedule (such as 4 times daily), you must stop this||
4247|093|H|schedule and only use it as needed for sudden shortness of||
4247|094|H|breath/asthma attacks. Consult your doctor for details.||
4247|095|H|   If you are only using this medication occasionally to prevent||
4247|096|H|asthma brought on by exercise (bronchospasm), use it at least 30||
4247|097|H|minutes before exercise, and do not use another dose for at least||
4247|098|H|12 hours. If you have sudden asthma/shortness of breath, use a||
4247|099|H|quick-relief inhaler (such as albuterol). Consult your doctor for||
4247|100|H|details.||
4247|101|H|   Learn which of your inhalers you should use every day||
4247|102|H|(controller drugs) and which you should use if your breathing||
4247|103|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
4247|104|H|time what you should do if you have new or worsening cough or||
4247|105|H|shortness of breath, wheezing, increased sputum, worsening peak||
4247|106|H|flow meter readings, waking up at night with trouble breathing,||
4247|107|H|if you use your quick-relief inhaler more often (more than 2 days||
4247|108|H|a week), or if your quick-relief inhaler does not seem to be||
4247|109|H|working well. Learn when you can treat sudden breathing problems||
4247|110|H|by yourself and when you must get medical help right away.||
4247|111|H|   Tell your doctor if your symptoms do not get better or if they||
4247|112|H|get worse.||
4247|113|B|||
4247|114|S|SIDE EFFECTS:  Hoarseness, throat irritation, headache, rapid||
4247|115|S|heartbeat, nervousness, cough, dry mouth/throat, or upset stomach||
4247|116|S|may occur. If any of these effects last or get worse, tell your||
4247|117|S|doctor or pharmacist promptly.||
4247|118|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
4247|119|S|chips, chew (sugarless) gum, drink water, or use a saliva||
4247|120|S|substitute.||
4247|121|S|   Remember that this medication has been prescribed because your||
4247|122|S|doctor has judged that the benefit to you is greater than the||
4247|123|S|risk of side effects. Many people using this medication do not||
4247|124|S|have serious side effects.||
4247|125|S|   This medication may raise your blood pressure. Check your||
4247|126|S|blood pressure regularly and tell your doctor if the results are||
4247|127|S|high.||
4247|128|S|   Rarely, this medication may cause sudden breathing||
4247|129|S|problems/asthma right after you use it. If this occurs, use your||
4247|130|S|quick-relief inhaler and get medical help right away.||
4247|131|S|   Get medical help right away if you have any very serious side||
4247|132|S|effects, including: chest pain, fast/slow/irregular heartbeat,||
4247|133|S|severe dizziness, fainting, seizures.||
4247|134|S|   A very serious allergic reaction to this product is rare.||
4247|135|S|However, get medical help right away if you notice any symptoms||
4247|136|S|of a serious allergic reaction, including: rash, itching/swelling||
4247|137|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4247|138|S|breathing.||
4247|139|S|   This is not a complete list of possible side effects. If you||
4247|140|S|notice other effects not listed above, contact your doctor or||
4247|141|S|pharmacist.||
4247|142|S|   In the US -||
4247|143|S|   Call your doctor for medical advice about side effects. You||
4247|144|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4247|145|S|www.fda.gov/medwatch.||
4247|146|S|   In Canada - Call your doctor for medical advice about side||
4247|147|S|effects. You may report side effects to Health Canada at||
4247|148|S|1-866-234-2345.||
4247|149|B|||
4247|150|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
4247|151|P|pharmacist if you are allergic to it; or if you have any other||
4247|152|P|allergies. This product may contain inactive ingredients, which||
4247|153|P|can cause allergic reactions or other problems. Talk to your||
4247|154|P|pharmacist for more details.||
4247|155|P|   Before using this drug, tell your doctor or pharmacist your||
4247|156|P|medical history, especially of: heart problems (such as angina,||
4247|157|P|irregular heartbeat), high blood pressure, diabetes, liver||
4247|158|P|problems, seizures, thyroid problems (such as overactive||
4247|159|P|thyroid).||
4247|160|P|   Salmeterol may cause a condition that affects the heart rhythm||
4247|161|P|(QT prolongation). QT prolongation can rarely cause serious||
4247|162|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
4247|163|P|as severe dizziness, fainting) that need medical attention right||
4247|164|P|away.||
4247|165|P|   The risk of QT prolongation may be increased if you have||
4247|166|P|certain medical conditions or are taking other drugs that may||
4247|167|P|cause QT prolongation. Before using salmeterol, tell your doctor||
4247|168|P|or pharmacist of all the drugs you take and if you have any of||
4247|169|P|the following conditions: certain heart problems (heart failure,||
4247|170|P|slow heartbeat, QT prolongation in the EKG), family history of||
4247|171|P|certain heart problems (QT prolongation in the EKG, sudden||
4247|172|P|cardiac death).||
4247|173|P|   Low levels of potassium or magnesium in the blood may also||
4247|174|P|increase your risk of QT prolongation. This risk may increase if||
4247|175|P|you use certain drugs (such as diuretics/"water pills") or if you||
4247|176|P|have conditions such as severe sweating, diarrhea, or vomiting.||
4247|177|P|Talk to your doctor about using salmeterol safely.||
4247|178|P|   Before having surgery, tell your doctor or dentist about all||
4247|179|P|the products you use (including prescription drugs,||
4247|180|P|nonprescription drugs, and herbal products).||
4247|181|P|   Older adults may be more sensitive to the side effects of this||
4247|182|P|drug, especially QT prolongation (see above).||
4247|183|P|   During pregnancy, this medication should be used only when||
4247|184|P|clearly needed. Discuss the risks and benefits with your doctor.||
4247|185|P|   It is unknown if this medication passes into breast milk.||
4247|186|P|Consult your doctor before breastfeeding.||
4247|187|B|||
4247|188|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4247|189|I|medications work or increase your risk for serious side effects.||
4247|190|I|This document does not contain all possible drug interactions.||
4247|191|I|Keep a list of all the products you use (including||
4247|192|I|prescription/nonprescription drugs and herbal products) and share||
4247|193|I|it with your doctor and pharmacist. Do not start, stop, or change||
4247|194|I|the dosage of any medicines without your doctor's approval.||
4247|195|I|   Many drugs besides salmeterol may affect the heart rhythm (QT||
4247|196|I|prolongation), including amiodarone, dofetilide, pimozide,||
4247|197|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
4247|198|I|erythromycin), among others. Before using salmeterol, report all||
4247|199|I|medications you are currently using to your doctor or pharmacist.||
4247|200|I|   Other medications can affect the removal of salmeterol from||
4247|201|I|your body, which may affect how salmeterol works. Examples||
4247|202|I|include cobicistat, nefazodone, ritonavir, telithromycin, azole||
4247|203|I|antifungals (such as ketoconazole, itraconazole), macrolide||
4247|204|I|antibiotics (such as clarithromycin), HIV protease inhibitors||
4247|205|I|(such as atazanavir, darunavir), among others.||
4247|206|B|||
4247|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4247|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4247|209|O|poison control center right away. US residents can call||
4247|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4247|211|O|Symptoms of overdose may include chest pain, fast/irregular||
4247|212|O|heartbeat, headache, fainting.||
4247|213|B|||
4247|214|N|NOTES:  Do not share this medication with others.||
4247|215|N|   Lab and/or medical tests (such as lung function) may be done||
4247|216|N|while you are using this medication. Keep all medical and lab||
4247|217|N|appointments. Consult your doctor for more details.||
4247|218|N|   Learn to use a peak flow meter, use it daily, and promptly||
4247|219|N|report worsening asthma (such as readings in the yellow/red||
4247|220|N|range, or increased use of quick-relief inhalers).||
4247|221|N|   Avoid allergens/irritants such as smoke, pollen, pet dander,||
4247|222|N|dust, or molds that may worsen asthma and other breathing||
4247|223|N|problems. Ask your doctor or pharmacist if you should have an||
4247|224|N|annual flu shot.||
4247|225|B|||
4247|226|D|MISSED DOSE:  If you are on a prescribed schedule and miss a||
4247|227|D|dose, skip the missed dose. Use your next dose at the regular||
4247|228|D|time. Do not double the dose to catch up.||
4247|229|B|||
4247|230|R|STORAGE:  Different brands of this medication have different||
4247|231|R|storage needs. Check the product package for instructions on how||
4247|232|R|to store your brand, or ask your pharmacist. Keep all medications||
4247|233|R|away from children and pets.||
4247|234|R|   Do not flush medications down the toilet or pour them into a||
4247|235|R|drain unless instructed to do so. Properly discard this product||
4247|236|R|when it is expired or no longer needed. Consult your pharmacist||
4247|237|R|or local waste disposal company.||
4247|238|B|||
4247|239|M|MEDICAL ALERT:  Your condition can cause complications in a||
4247|240|M|medical emergency. For information about enrolling in MedicAlert,||
4247|241|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4247|242|B|||
4247|243|A|Information last revised February 2025.||
4247|244|A|Copyright(c) 2025 First Databank, Inc.||
4247|245|B|||
4249|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4249|002|Z|does NOT have all possible information about this product. This||
4249|003|Z|information does not assure that this product is safe, effective,||
4249|004|Z|or appropriate for you. This information is not individual||
4249|005|Z|medical advice and does not substitute for the advice of your||
4249|006|Z|health care professional. Always ask your health care||
4249|007|Z|professional for complete information about this product and your||
4249|008|Z|specific health needs.||
4249|009|B|||
4249|010|T|MULTIVITAMINS (INCLUDES PRENATAL VITAMINS) LIQUID - ORAL||
4249|011|B|||
4249|012|W|WARNING:  If your brand of multivitamin contains iron, it is||
4249|013|W|important to keep this product out of reach of children.||
4249|014|W|Accidental overdose of iron-containing products is a leading||
4249|015|W|cause of fatal poisoning in children younger than 6 years. If||
4249|016|W|overdose does occur, get medical help right away or call a poison||
4249|017|W|control center.||
4249|018|B|||
4249|019|U|USES:  This medication is a multivitamin product used to treat or||
4249|020|U|prevent vitamin deficiency due to poor diet, certain illnesses,||
4249|021|U|or during pregnancy. Vitamins are important building blocks of||
4249|022|U|the body and help keep you in good health.||
4249|023|B|||
4249|024|H|HOW TO USE:  Take this medication by mouth, usually once daily or||
4249|025|H|as directed. Follow all directions on the product package, or||
4249|026|H|take as directed by your doctor. Do not take more than the||
4249|027|H|recommended dosage. If you have any questions, ask your doctor or||
4249|028|H|pharmacist.||
4249|029|H|   Carefully measure the dose using a special measuring||
4249|030|H|device/spoon. Do not use a household spoon because you may not||
4249|031|H|get the correct dose. If your liquid is a suspension, shake the||
4249|032|H|bottle well before each dose.||
4249|033|H|   Take this medication regularly in order to get the most||
4249|034|H|benefit from it. To help you remember, take it at the same time||
4249|035|H|each day.||
4249|036|B|||
4249|037|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
4249|038|S|occur. These effects are usually temporary and may disappear as||
4249|039|S|your body adjusts to this medication. If any of these effects||
4249|040|S|last or get worse, tell your doctor or pharmacist promptly.||
4249|041|S|   If your doctor has directed you to use this medication,||
4249|042|S|remember that your doctor has judged that the benefit to you is||
4249|043|S|greater than the risk of side effects. Many people using this||
4249|044|S|medication do not have serious side effects.||
4249|045|S|   A very serious allergic reaction to this drug is rare.||
4249|046|S|However, get medical help right away if you notice any symptoms||
4249|047|S|of a serious allergic reaction, including: rash, itching/swelling||
4249|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4249|049|S|breathing.||
4249|050|S|   This is not a complete list of possible side effects. If you||
4249|051|S|notice other effects not listed above, contact your doctor or||
4249|052|S|pharmacist.||
4249|053|S|   In the US -||
4249|054|S|   Call your doctor for medical advice about side effects. You||
4249|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4249|056|S|www.fda.gov/medwatch.||
4249|057|S|   In Canada - Call your doctor for medical advice about side||
4249|058|S|effects. You may report side effects to Health Canada at||
4249|059|S|1-866-234-2345.||
4249|060|B|||
4249|061|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
4249|062|P|pharmacist if you are allergic to any of its ingredients; or if||
4249|063|P|you have any other allergies. This product may contain inactive||
4249|064|P|ingredients, which can cause allergic reactions or other||
4249|065|P|problems. Talk to your pharmacist for more details.||
4249|066|P|   Before taking this medication, tell your doctor or pharmacist||
4249|067|P|your medical history, especially of: use/abuse of alcohol, liver||
4249|068|P|problems, stomach/intestinal problems (such as ulcer, colitis).||
4249|069|P|   If your brand of multivitamin also contains folic acid, be||
4249|070|P|sure to tell your doctor or pharmacist if you have vitamin B12||
4249|071|P|deficiency (pernicious anemia) before taking it. Folic acid may||
4249|072|P|affect certain lab tests for vitamin B12 deficiency without||
4249|073|P|treating this anemia. Untreated vitamin B12 deficiency may result||
4249|074|P|in serious nerve problems (such as peripheral neuropathy).||
4249|075|P|Consult your doctor or pharmacist for details.||
4249|076|P|   Liquid preparations of this product may contain sugar and/or||
4249|077|P|alcohol. Caution is advised if you have diabetes, alcohol||
4249|078|P|dependence, or liver disease. Ask your doctor or pharmacist about||
4249|079|P|using this product safely.||
4249|080|P|   Before having surgery, tell your doctor or dentist about all||
4249|081|P|the products you use (including prescription drugs,||
4249|082|P|nonprescription drugs, and herbal products).||
4249|083|P|   Tell your doctor if you are pregnant before using this||
4249|084|P|medication.||
4249|085|P|   This medication passes into breast milk. Consult your doctor||
4249|086|P|before breastfeeding.||
4249|087|B|||
4249|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4249|089|I|medications work or increase your risk for serious side effects.||
4249|090|I|This document does not contain all possible drug interactions.||
4249|091|I|Keep a list of all the products you use (including||
4249|092|I|prescription/nonprescription drugs and herbal products) and share||
4249|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
4249|094|I|the dosage of any medicines without your doctor's approval.||
4249|095|I|   If your brand of multivitamin also contains calcium, iron,||
4249|096|I|magnesium, or zinc, then it can decrease the absorption of||
4249|097|I|certain drugs, especially if you take them around the same time.||
4249|098|I|These drugs include bisphosphonates (such as alendronate),||
4249|099|I|levodopa, penicillamine, quinolone antibiotics (such as||
4249|100|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
4249|101|I|doxycycline, minocycline), thyroid medications (such as||
4249|102|I|levothyroxine), among others. Ask your doctor or pharmacist how||
4249|103|I|long you should wait between doses of this product and your other||
4249|104|I|medications and to find a dosing schedule that works for all your||
4249|105|I|medications.||
4249|106|B|||
4249|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4249|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4249|109|O|poison control center right away. US residents can call||
4249|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4249|111|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
4249|112|O|diarrhea.||
4249|113|B|||
4249|114|N|NOTES:  Keep all medical and lab appointments.||
4249|115|N|   This product is not a substitute for a proper diet. Remember||
4249|116|N|that it is best to get your vitamins from healthy foods. Maintain||
4249|117|N|a well-balanced diet and follow any dietary guidelines as||
4249|118|N|directed by your doctor.||
4249|119|B|||
4249|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4249|121|D|remember. If it is near the time of the next dose, skip the||
4249|122|D|missed dose. Take your next dose at the regular time. Do not||
4249|123|D|double the dose to catch up.||
4249|124|B|||
4249|125|R|STORAGE:  Different brands of this medication have different||
4249|126|R|storage needs. Check the product package for instructions on how||
4249|127|R|to store your brand, or ask your pharmacist. Keep all medications||
4249|128|R|away from children and pets.||
4249|129|R|   Do not flush medications down the toilet or pour them into a||
4249|130|R|drain unless instructed to do so. Properly discard this product||
4249|131|R|when it is expired or no longer needed. Consult your pharmacist||
4249|132|R|or local waste disposal company.||
4249|133|B|||
4249|134|A|Information last revised October 2025.||
4249|135|A|Copyright(c) 2025 First Databank, Inc.||
4249|136|B|||
4250|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4250|002|Z|does NOT have all possible information about this product. This||
4250|003|Z|information does not assure that this product is safe, effective,||
4250|004|Z|or appropriate for you. This information is not individual||
4250|005|Z|medical advice and does not substitute for the advice of your||
4250|006|Z|health care professional. Always ask your health care||
4250|007|Z|professional for complete information about this product and your||
4250|008|Z|specific health needs.||
4250|009|B|||
4250|010|T|FAMOTIDINE/CALCIUM CARBONATE/MAGNESIUM HYDROXIDE - CHEWABLE||
4250|011|F|(fam-OH-ti-deen/KAL-see-um KAR-bo-nate/||
4250|012|F|mag-NEE-zee-um hye-DROX-ide)||
4250|013|B|||
4250|014|C|COMMON BRAND NAME(S): Pepcid Complete||
4250|015|B|||
4250|016|U|USES:  This combination of three medications is used to treat||
4250|017|U|heartburn and other symptoms caused by too much acid in the||
4250|018|U|stomach (acid indigestion). Famotidine is a drug that blocks acid||
4250|019|U|release in the stomach and can help stop heartburn and acid||
4250|020|U|indigestion from coming back. Calcium carbonate and magnesium||
4250|021|U|hydroxide are antacids that work quickly to lower acid in the||
4250|022|U|stomach and stop heartburn.||
4250|023|B|||
4250|024|H|HOW TO USE:  Chew one tablet completely and swallow as needed to||
4250|025|H|stop/prevent the symptoms of heartburn and indigestion, or take||
4250|026|H|as directed by your doctor. Do not swallow the tablets whole.||
4250|027|H|   Do not take more than 2 tablets within 24 hours. Follow all||
4250|028|H|directions on the product package. If you have any questions, ask||
4250|029|H|your doctor or pharmacist.||
4250|030|H|   Tell your doctor if your symptoms last or if they get worse.||
4250|031|H|Do not take this medicine for more than 14 days in a row without||
4250|032|H|talking with your doctor.||
4250|033|B|||
4250|034|S|SIDE EFFECTS:  Diarrhea, headache, constipation, or stomach||
4250|035|S|cramps may occur. If any of these effects last or get worse, tell||
4250|036|S|your doctor or pharmacist promptly.||
4250|037|S|   If your doctor has directed you to use this medication,||
4250|038|S|remember that your doctor has judged that the benefit to you is||
4250|039|S|greater than the risk of side effects. Many people using this||
4250|040|S|medication do not have serious side effects.||
4250|041|S|   Tell your doctor right away if you have any serious side||
4250|042|S|effects, including: easy bruising/bleeding, signs of infection||
4250|043|S|(such as sore throat that doesn't go away, fever, chills),||
4250|044|S|mental/mood changes (such as restlessness, confusion, depression,||
4250|045|S|hallucinations).||
4250|046|S|   Get medical help right away if you have any very serious side||
4250|047|S|effects, including: fast/slow/irregular heartbeat, severe||
4250|048|S|dizziness, fainting, seizure.||
4250|049|S|   A very serious allergic reaction to this drug is rare.||
4250|050|S|However, get medical help right away if you notice any symptoms||
4250|051|S|of a serious allergic reaction, including: rash, itching/swelling||
4250|052|S|(especially of the face/tongue/throat), trouble breathing.||
4250|053|S|   This is not a complete list of possible side effects. If you||
4250|054|S|notice any other effects not listed above, contact your doctor or||
4250|055|S|pharmacist.||
4250|056|S|   In the US -||
4250|057|S|   Call your doctor for medical advice about side effects. You||
4250|058|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4250|059|S|www.fda.gov/medwatch.||
4250|060|S|   In Canada - Call your doctor for medical advice about side||
4250|061|S|effects. You may report side effects to Health Canada at||
4250|062|S|1-866-234-2345.||
4250|063|B|||
4250|064|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
4250|065|P|pharmacist if you are allergic to famotidine; or to other H2||
4250|066|P|blockers (such as cimetidine, ranitidine); or to other antacids||
4250|067|P|containing calcium/magnesium; or if you have any other allergies.||
4250|068|P|This product may contain inactive ingredients, which can cause||
4250|069|P|allergic reactions or other problems. Talk to your pharmacist for||
4250|070|P|more details.||
4250|071|P|   If you have any of the following health problems, consult your||
4250|072|P|doctor or pharmacist before using this product: kidney problems,||
4250|073|P|liver problems, other stomach problems (such as tumors).||
4250|074|P|   Some symptoms may actually be signs of a more serious||
4250|075|P|condition. Get medical help right away if you have: heartburn||
4250|076|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
4250|077|P|pain (especially with shortness of breath, unusual sweating),||
4250|078|P|unexplained weight loss.||
4250|079|P|   In addition, before you self-treat with this medication, get||
4250|080|P|medical help right away if you have any of these signs of a||
4250|081|P|serious condition: trouble/pain swallowing food, bloody vomit,||
4250|082|P|vomit that looks like coffee grounds, bloody/black stools,||
4250|083|P|heartburn for over 3 months, frequent chest pain, frequent||
4250|084|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
4250|085|P|pain.||
4250|086|P|   Do not use this medication in children younger than 12 unless||
4250|087|P|directed by the doctor.||
4250|088|P|   Older adults may be more sensitive to the side effects of this||
4250|089|P|drug, especially mental/mood changes (such as confusion),||
4250|090|P|seizure, or unusual tiredness.||
4250|091|P|   During pregnancy, this medication should be used only when||
4250|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
4250|093|P|Tell your doctor if you are pregnant before using this||
4250|094|P|medication.||
4250|095|P|   This drug passes into breast milk. Consult your doctor before||
4250|096|P|breastfeeding.||
4250|097|B|||
4250|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4250|099|I|medications work or increase your risk for serious side effects.||
4250|100|I|This document does not contain all possible drug interactions.||
4250|101|I|Keep a list of all the products you use (including||
4250|102|I|prescription/nonprescription drugs and herbal products) and share||
4250|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
4250|104|I|the dosage of any medicines without your doctor's approval.||
4250|105|I|   A product that may interact with this drug is: fezolinetant.||
4250|106|I|   Some products need stomach acid so that the body can absorb||
4250|107|I|them properly. Famotidine and antacids decrease stomach acid, so||
4250|108|I|this medication may change how well these products work. Some||
4250|109|I|affected products include atazanavir, dasatinib, certain azole||
4250|110|I|antifungals (such as itraconazole, ketoconazole),||
4250|111|I|levoketoconazole, pazopanib, sparsentan, among others.||
4250|112|I|   The calcium and magnesium in this product can decrease the||
4250|113|I|absorption of certain drugs, especially if you take them around||
4250|114|I|the same time. These drugs include bisphosphonates (such as||
4250|115|I|alendronate), penicillamine, quinolone antibiotics (such as||
4250|116|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
4250|117|I|doxycycline, minocycline), thyroid medications (such as||
4250|118|I|levothyroxine), among others. Ask your doctor or pharmacist how||
4250|119|I|long you should wait between doses of this product and your other||
4250|120|I|medications and to find a dosing schedule that works for all your||
4250|121|I|medications.||
4250|122|I|   Do not take this medication with other products that contain||
4250|123|I|famotidine or other H2 blockers (cimetidine, nizatidine,||
4250|124|I|ranitidine).||
4250|125|B|||
4250|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4250|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4250|128|O|poison control center right away. US residents can call||
4250|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4250|130|B|||
4250|131|N|NOTES:  Lifestyle changes such as stress reduction programs,||
4250|132|N|stopping smoking, limiting alcohol, and diet changes (such as||
4250|133|N|avoiding caffeine and certain spices) may help this medication||
4250|134|N|work better. Talk to your doctor or pharmacist about lifestyle||
4250|135|N|changes that might benefit you.||
4250|136|B|||
4250|137|D|MISSED DOSE:  Not applicable.||
4250|138|B|||
4250|139|R|STORAGE:  Store at room temperature away from light and moisture.||
4250|140|R|Do not store in the bathroom. Keep all medications away from||
4250|141|R|children and pets.||
4250|142|R|   Do not flush medications down the toilet or pour them into a||
4250|143|R|drain unless instructed to do so. Properly discard this product||
4250|144|R|when it is expired or no longer needed. Consult your pharmacist||
4250|145|R|or local waste disposal company.||
4250|146|B|||
4250|147|A|Information last revised October 2025.||
4250|148|A|Copyright(c) 2025 First Databank, Inc.||
4250|149|B|||
4253|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4253|002|Z|does NOT have all possible information about this product. This||
4253|003|Z|information does not assure that this product is safe, effective,||
4253|004|Z|or appropriate for you. This information is not individual||
4253|005|Z|medical advice and does not substitute for the advice of your||
4253|006|Z|health care professional. Always ask your health care||
4253|007|Z|professional for complete information about this product and your||
4253|008|Z|specific health needs.||
4253|009|B|||
4253|010|T|MOMETASONE SPRAY - NASAL||
4253|011|F|(mow-MET-uh-sown)||
4253|012|B|||
4253|013|C|COMMON BRAND NAME(S): Nasonex||
4253|014|B|||
4253|015|U|USES:  Mometasone is used to prevent and treat seasonal and||
4253|016|U|year-round allergy symptoms (such as stuffy/runny nose, itching,||
4253|017|U|and sneezing). It is also used to treat certain growths in the||
4253|018|U|nose (nasal polyps). Mometasone belongs to a class of drugs known||
4253|019|U|as corticosteroids. It works by reducing swelling (inflammation)||
4253|020|U|in the nasal passages.||
4253|021|B|||
4253|022|V|OTHER USES:  This section contains uses of this drug that are not||
4253|023|V|listed in the approved US professional labeling for the drug but||
4253|024|V|that may be prescribed by your health care professional. Use this||
4253|025|V|drug for a condition that is listed in this section only if it||
4253|026|V|has been so prescribed by your health care professional.||
4253|027|V|   This drug may also be used for sinus inflammation (sinusitis).||
4253|028|V|It should be used with an antibiotic if sinusitis is caused by a||
4253|029|V|bacterial infection.||
4253|030|B|||
4253|031|H|HOW TO USE:  If you are using the over-the-counter product to||
4253|032|H|self-treat, read and follow all directions on the product package||
4253|033|H|before using this medication. If you have any questions, consult||
4253|034|H|your pharmacist. If your doctor has prescribed this medication,||
4253|035|H|use it as directed.||
4253|036|H|   Read the Patient Information Leaflet if available from your||
4253|037|H|pharmacist before you start using mometasone and each time you||
4253|038|H|get a refill. Follow the illustrated directions for the proper||
4253|039|H|use of this medication. If you have any questions, ask your||
4253|040|H|doctor or pharmacist.||
4253|041|H|   Use this medication in the nose as directed by your doctor or||
4253|042|H|the product package, usually once or twice daily. Do not spray in||
4253|043|H|the eyes or mouth. Gently blow your nose before using this drug.||
4253|044|H|Shake the bottle well before each use. Follow the instructions to||
4253|045|H|properly prime the spray pump.||
4253|046|H|   Remove the protective cap before use. Close one nostril by||
4253|047|H|pressing it with your finger. Tilt your head forward and||
4253|048|H|carefully insert the nasal applicator into the other nostril.||
4253|049|H|Press down firmly on the bottle to deliver the prescribed number||
4253|050|H|of sprays. Do not spray directly onto the middle wall of your||
4253|051|H|nose (nasal septum). Breathe in gently through your nose and out||
4253|052|H|through your mouth. Repeat in the other nostril. Wipe the||
4253|053|H|applicator tip and replace the plastic cap. Avoid blowing your||
4253|054|H|nose for 15 minutes after using this medication. If a child is||
4253|055|H|using this medication, an adult should supervise the child.||
4253|056|H|   The dosage is based on your age, medical condition, and||
4253|057|H|response to treatment. Do not increase your dose or use this drug||
4253|058|H|more often or for longer than directed. Your condition will not||
4253|059|H|improve any faster, and your risk of side effects will increase.||
4253|060|H|Children may need to use this drug for a shorter amount of time||
4253|061|H|to lower the risk of side effects. If a child is using the||
4253|062|H|over-the-counter product, read the package information to see how||
4253|063|H|long it may be used and when you should check with the doctor.||
4253|064|H|   This medication does not work right away. Some people will||
4253|065|H|feel this medication working within 1 to 2 days, but it may take||
4253|066|H|up to 2 weeks before the full benefit of this drug takes effect.||
4253|067|H|When using mometasone to prevent seasonal allergy symptoms, you||
4253|068|H|may need to start this medication 2 to 4 weeks before pollen||
4253|069|H|season begins. Ask your doctor or pharmacist if you should also||
4253|070|H|use other medications (such as nose drops/spray, allergy drugs||
4253|071|H|taken by mouth) along with this drug until it takes full effect.||
4253|072|H|   Keep track of the number of sprays used from the bottle.||
4253|073|H|Discard the bottle after you have used the number of sprays||
4253|074|H|specified on the manufacturer's package. Follow the package||
4253|075|H|instructions to unblock the spray tip if needed and to clean the||
4253|076|H|spray bottle.||
4253|077|H|   Tell your doctor if your symptoms do not get better or if they||
4253|078|H|get worse.||
4253|079|B|||
4253|080|S|SIDE EFFECTS:  See also Precautions.||
4253|081|S|   Nose/throat dryness or irritation, blood-tinged mucus/phlegm,||
4253|082|S|and nosebleeds may occur. If any of these side effects last or||
4253|083|S|get worse, tell your doctor or pharmacist promptly.||
4253|084|S|   If your doctor has prescribed this medication, remember that||
4253|085|S|your doctor has judged that the benefit to you is greater than||
4253|086|S|the risk of side effects. Many people using this medication do||
4253|087|S|not have serious side effects.||
4253|088|S|   Tell your doctor right away if you have any serious side||
4253|089|S|effects, including: pain/sores in your nose, white patches in||
4253|090|S|your nose/mouth, painful swallowing/trouble swallowing.||
4253|091|S|   Rarely, it is possible that corticosteroids given in the nose||
4253|092|S|will be absorbed into the bloodstream. This can lead to side||
4253|093|S|effects of too much corticosteroid. These side effects are more||
4253|094|S|likely in children and people who use this medication for a long||
4253|095|S|time and in high doses. Tell your doctor right away if any of the||
4253|096|S|following side effects occur: unusual/extreme tiredness, weight||
4253|097|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
4253|098|S|vision problems.||
4253|099|S|   A very serious allergic reaction to this drug is rare.||
4253|100|S|However, get medical help right away if you notice any symptoms||
4253|101|S|of a serious allergic reaction, including: rash, itching/swelling||
4253|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4253|103|S|breathing.||
4253|104|S|   This is not a complete list of possible side effects. If you||
4253|105|S|notice other effects not listed above, contact your doctor or||
4253|106|S|pharmacist.||
4253|107|S|   In the US -||
4253|108|S|   Call your doctor for medical advice about side effects. You||
4253|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4253|110|S|www.fda.gov/medwatch.||
4253|111|S|   In Canada - Call your doctor for medical advice about side||
4253|112|S|effects. You may report side effects to Health Canada at||
4253|113|S|1-866-234-2345.||
4253|114|B|||
4253|115|P|PRECAUTIONS:  Before using mometasone, tell your doctor or||
4253|116|P|pharmacist if you are allergic to it; or if you have any other||
4253|117|P|allergies. This product may contain inactive ingredients, which||
4253|118|P|can cause allergic reactions or other problems. Talk to your||
4253|119|P|pharmacist for more details.||
4253|120|P|   Before using this medication, tell your doctor or pharmacist||
4253|121|P|your medical history, especially of: eye problems (such as||
4253|122|P|glaucoma, cataracts), infections (including tuberculosis, herpes||
4253|123|P|eye infection), recent nose problems (such as injury, ulcers,||
4253|124|P|surgery).||
4253|125|P|   Stay away from anyone who has an infection that may easily||
4253|126|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
4253|127|P|doctor if you have been exposed to an infection or for more||
4253|128|P|details.||
4253|129|P|   Rarely, using corticosteroid medications for a long time can||
4253|130|P|make it more difficult for your body to respond to physical||
4253|131|P|stress. Before having surgery or emergency treatment, or if you||
4253|132|P|get a serious illness/injury, tell your doctor or dentist that||
4253|133|P|you are using this medication or have used this medication within||
4253|134|P|the past few months.||
4253|135|P|   Before having surgery, tell your doctor or dentist about all||
4253|136|P|the products you use (including prescription drugs,||
4253|137|P|nonprescription drugs, and herbal products).||
4253|138|P|   Though it is unlikely, this medication may temporarily slow||
4253|139|P|down a child's growth if used for a long time. See the doctor||
4253|140|P|regularly so your child's height can be checked.||
4253|141|P|   During pregnancy, this medication should be used only when||
4253|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
4253|143|P|   It is unknown if this drug passes into breast milk. Consult||
4253|144|P|your doctor before breastfeeding.||
4253|145|B|||
4253|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4253|147|I|medications work or increase your risk for serious side effects.||
4253|148|I|This document does not contain all possible drug interactions.||
4253|149|I|Keep a list of all the products you use (including||
4253|150|I|prescription/nonprescription drugs and herbal products) and share||
4253|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
4253|152|I|the dosage of any medicines without your doctor's approval.||
4253|153|B|||
4253|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4253|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4253|156|O|poison control center right away. US residents can call||
4253|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4253|158|B|||
4253|159|N|NOTES:  If you are using this medication for a long time, lab||
4253|160|N|and/or medical tests (such as nose/eye exams, height measurement||
4253|161|N|in children) may be done. Keep all medical and lab appointments.||
4253|162|N|Consult your doctor for more details.||
4253|163|B|||
4253|164|D|MISSED DOSE:  If you are using this product on a regular schedule||
4253|165|D|and miss a dose, use it as soon as you remember. If it is near||
4253|166|D|the time of the next dose, skip the missed dose. Use your next||
4253|167|D|dose at the regular time. Do not double the dose to catch up.||
4253|168|B|||
4253|169|R|STORAGE:  Different brands of this medication have different||
4253|170|R|storage needs. Check the product package for instructions on how||
4253|171|R|to store your brand, or ask your pharmacist. Keep all medications||
4253|172|R|away from children and pets.||
4253|173|R|   Do not flush medications down the toilet or pour them into a||
4253|174|R|drain unless instructed to do so. Properly discard this product||
4253|175|R|when it is expired or no longer needed. Consult your pharmacist||
4253|176|R|or local waste disposal company.||
4253|177|B|||
4253|178|A|Information last revised February 2025.||
4253|179|A|Copyright(c) 2025 First Databank, Inc.||
4253|180|B|||
4262|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4262|002|Z|does NOT have all possible information about this product. This||
4262|003|Z|information does not assure that this product is safe, effective,||
4262|004|Z|or appropriate for you. This information is not individual||
4262|005|Z|medical advice and does not substitute for the advice of your||
4262|006|Z|health care professional. Always ask your health care||
4262|007|Z|professional for complete information about this product and your||
4262|008|Z|specific health needs.||
4262|009|B|||
4262|010|T|TERBINAFINE SOLUTION - TOPICAL||
4262|011|F|(ter-BIN-uh-feen)||
4262|012|B|||
4262|013|C|COMMON BRAND NAME(S): Lamisil||
4262|014|B|||
4262|015|U|USES:  This medication is used to treat a variety of fungal skin||
4262|016|U|infections such as ringworm, athlete's foot, and jock itch. This||
4262|017|U|medication is also used to treat a skin condition known as||
4262|018|U|pityriasis (tinea versicolor), a fungal infection that causes a||
4262|019|U|lightening or darkening of the skin of the neck, chest, arms, or||
4262|020|U|legs. Terbinafine is an antifungal that works by preventing the||
4262|021|U|growth of fungus.||
4262|022|B|||
4262|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
4262|024|H|thoroughly dry the area to be treated. Apply enough medication to||
4262|025|H|wet the skin on and around the affected area, usually once or||
4262|026|H|twice daily as directed on the product package. If you have any||
4262|027|H|questions, ask your doctor or pharmacist. If your doctor has||
4262|028|H|prescribed this medication to you, then use as directed. Wash||
4262|029|H|your hands after using unless the area being treated includes the||
4262|030|H|hands. Do not wrap, cover, or bandage the area unless directed to||
4262|031|H|do so by your doctor.||
4262|032|H|   Do not use the medication in the eyes, nose, or mouth, or||
4262|033|H|inside the vagina. If you do get the medication in those areas,||
4262|034|H|flush with plenty of water.||
4262|035|H|   Do not use this medication on the scalp or nails unless||
4262|036|H|otherwise directed by your doctor.||
4262|037|H|   Do not use the spray form of this medication on the face.||
4262|038|H|   The dosage and length of treatment depends on the type of||
4262|039|H|infection being treated.||
4262|040|H|   Do not apply more often or use longer than directed. This may||
4262|041|H|increase the risk of side effects.||
4262|042|H|   Use this medication regularly to get the most benefit from it.||
4262|043|H|To help you remember, use it at the same time(s) each day.||
4262|044|H|   Continue to use this medication as directed until the full||
4262|045|H|treatment period is finished, even if symptoms disappear after a||
4262|046|H|few days. Stopping the medication too early may result in a||
4262|047|H|return of the infection.||
4262|048|H|   Your condition may continue to improve after stopping the||
4262|049|H|medication as directed. Tell your doctor if your condition gets||
4262|050|H|worse or if it does not get better after 1 week of treatment.||
4262|051|B|||
4262|052|S|SIDE EFFECTS:  Burning, irritation, redness, or itching at the||
4262|053|S|application site may occur. If any of these effects last or get||
4262|054|S|worse, tell your doctor or pharmacist promptly.||
4262|055|S|   If your doctor has prescribed this medication, remember that||
4262|056|S|your doctor has judged that the benefit to you is greater than||
4262|057|S|the risk of side effects. Many people using this medication do||
4262|058|S|not have serious side effects.||
4262|059|S|   Tell your doctor right away if you have any serious side||
4262|060|S|effects, including: blistering/swelling/oozing at the application||
4262|061|S|site.||
4262|062|S|   A very serious allergic reaction to this drug is rare.||
4262|063|S|However, get medical help right away if you notice any symptoms||
4262|064|S|of a serious allergic reaction, including: rash, itching/swelling||
4262|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4262|066|S|breathing.||
4262|067|S|   This is not a complete list of possible side effects. If you||
4262|068|S|notice other effects not listed above, contact your doctor or||
4262|069|S|pharmacist.||
4262|070|S|   In the US -||
4262|071|S|   Call your doctor for medical advice about side effects. You||
4262|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4262|073|S|www.fda.gov/medwatch.||
4262|074|S|   In Canada - Call your doctor for medical advice about side||
4262|075|S|effects. You may report side effects to Health Canada at||
4262|076|S|1-866-234-2345.||
4262|077|B|||
4262|078|P|PRECAUTIONS:  Before using terbinafine, tell your doctor or||
4262|079|P|pharmacist if you are allergic to it; or to other allylamine||
4262|080|P|antifungals (such as naftifine); or if you have any other||
4262|081|P|allergies. This product may contain inactive ingredients, which||
4262|082|P|can cause allergic reactions or other problems. Talk to your||
4262|083|P|pharmacist for more details.||
4262|084|P|   Before using this medication, tell your doctor or pharmacist||
4262|085|P|your medical history, especially of: broken skin (lesions).||
4262|086|P|   During pregnancy, this medication should be used only when||
4262|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
4262|088|P|   It is unknown if this drug passes into breast milk when||
4262|089|P|applied to the skin. Other forms of this medication pass into||
4262|090|P|breast milk when taken by mouth. Consult your doctor before||
4262|091|P|breastfeeding.||
4262|092|B|||
4262|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4262|094|I|medications work or increase your risk for serious side effects.||
4262|095|I|This document does not contain all possible drug interactions.||
4262|096|I|Keep a list of all the products you use (including||
4262|097|I|prescription/nonprescription drugs and herbal products) and share||
4262|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
4262|099|I|the dosage of any medicines without your doctor's approval.||
4262|100|B|||
4262|101|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
4262|102|O|has overdosed and has serious symptoms such as passing out or||
4262|103|O|trouble breathing, call 911. Otherwise, call a poison control||
4262|104|O|center right away. US residents can call 1-800-222-1222. Canada||
4262|105|O|residents can call 1-844-764-7669.||
4262|106|B|||
4262|107|N|NOTES:  Do not share this medication with others.||
4262|108|N|   If your doctor has directed you to use this medication, use it||
4262|109|N|for your current condition only. Do not use it later for another||
4262|110|N|infection unless your doctor tells you to.||
4262|111|N|   If you are treating athlete's foot, make sure to wear||
4262|112|N|well-fitting, ventilated shoes. Also, change shoes and socks at||
4262|113|N|least once daily.||
4262|114|N|   When this medication is used to treat pityriasis, your normal||
4262|115|N|skin color may not return right away. It may take several months||
4262|116|N|after treatment is completed for your natural skin color to||
4262|117|N|return.||
4262|118|B|||
4262|119|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4262|120|D|If it is near the time of the next dose, skip the missed dose.||
4262|121|D|Use your next dose at the regular time. Do not double the dose to||
4262|122|D|catch up.||
4262|123|B|||
4262|124|R|STORAGE:  Store at room temperature away from heat and open||
4262|125|R|flame. Do not puncture the bottle. Do not refrigerate. Keep all||
4262|126|R|medications away from children and pets.||
4262|127|R|   Do not flush medications down the toilet or pour them into a||
4262|128|R|drain unless instructed to do so. Properly discard this product||
4262|129|R|when it is expired or no longer needed. Consult your pharmacist||
4262|130|R|or local waste disposal company.||
4262|131|B|||
4262|132|A|Information last revised November 2024.||
4262|133|A|Copyright(c) 2025 First Databank, Inc.||
4262|134|B|||
4269|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4269|002|Z|does NOT have all possible information about this product. This||
4269|003|Z|information does not assure that this product is safe, effective,||
4269|004|Z|or appropriate for you. This information is not individual||
4269|005|Z|medical advice and does not substitute for the advice of your||
4269|006|Z|health care professional. Always ask your health care||
4269|007|Z|professional for complete information about this product and your||
4269|008|Z|specific health needs.||
4269|009|B|||
4269|010|T|CEFDINIR - ORAL||
4269|011|F|(SEFF-dih-neer)||
4269|012|B|||
4269|013|C|COMMON BRAND NAME(S): Omnicef||
4269|014|B|||
4269|015|U|USES:  Cefdinir is used to treat a wide variety of bacterial||
4269|016|U|infections. This medication is known as a cephalosporin||
4269|017|U|antibiotic. It works by stopping the growth of bacteria.||
4269|018|U|   This antibiotic treats only bacterial infections. It will not||
4269|019|U|work for viral infections (such as common cold, flu). Using any||
4269|020|U|antibiotic when it is not needed can cause it to not work for||
4269|021|U|future infections.||
4269|022|B|||
4269|023|H|HOW TO USE:  Take this medication by mouth with or without food||
4269|024|H|as directed by your doctor, usually once a day or twice a day||
4269|025|H|(every 12 hours).||
4269|026|H|   The dosage is based on your medical condition and response to||
4269|027|H|treatment.||
4269|028|H|   For the best effect, take this antibiotic at evenly spaced||
4269|029|H|times. To help you remember, take this medication at the same||
4269|030|H|time(s) every day.||
4269|031|H|   Continue to use this medication until the full prescribed||
4269|032|H|amount is finished, even if symptoms disappear after a few days.||
4269|033|H|Stopping the medication too early may result in a return of the||
4269|034|H|infection.||
4269|035|H|   Some medications can bind with cefdinir preventing its full||
4269|036|H|absorption. If you take antacids containing magnesium or||
4269|037|H|aluminum, iron supplements, or vitamin/mineral products, take||
4269|038|H|them at least 2 hours apart from cefdinir.||
4269|039|H|   Tell your doctor if your condition lasts or gets worse.||
4269|040|B|||
4269|041|S|SIDE EFFECTS:  Diarrhea, headache, or nausea may occur. If any of||
4269|042|S|these effects last or get worse, tell your doctor or pharmacist||
4269|043|S|promptly.||
4269|044|S|   This medication may cause your stools to turn a reddish color,||
4269|045|S|especially if you also take iron products. This is harmless.||
4269|046|S|   Remember that this medication has been prescribed because your||
4269|047|S|doctor has judged that the benefit to you is greater than the||
4269|048|S|risk of side effects. Many people using this medication do not||
4269|049|S|have serious side effects.||
4269|050|S|   Tell your doctor right away if you have any serious side||
4269|051|S|effects, including: signs of liver disease (such as||
4269|052|S|nausea/vomiting that doesn't stop, loss of appetite,||
4269|053|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), unusual||
4269|054|S|tiredness, new signs of infection (such as sore throat that||
4269|055|S|doesn't go away, fever, chills), easy bruising/bleeding, signs of||
4269|056|S|kidney problems (such as change in the amount of urine),||
4269|057|S|mental/mood changes (such as confusion).||
4269|058|S|   This medication may rarely cause a severe intestinal condition||
4269|059|S|due to a bacteria called C. difficile. This condition may occur||
4269|060|S|during treatment or weeks to months after treatment has stopped.||
4269|061|S|Tell your doctor right away if you develop: diarrhea that doesn't||
4269|062|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
4269|063|S|stool.||
4269|064|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4269|065|S|products because they may make symptoms worse.||
4269|066|S|   Use of this medication for prolonged or repeated periods may||
4269|067|S|result in oral thrush or a new vaginal yeast infection (oral or||
4269|068|S|vaginal fungal infection). Contact your doctor if you notice||
4269|069|S|white patches in your mouth, a change in vaginal discharge or||
4269|070|S|other new symptoms.||
4269|071|S|   A very serious allergic reaction to this drug is rare.||
4269|072|S|However, get medical help right away if you notice any symptoms||
4269|073|S|of a serious allergic reaction, including: rash, itching/swelling||
4269|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4269|075|S|breathing.||
4269|076|S|   This is not a complete list of possible side effects. If you||
4269|077|S|notice other effects not listed above, contact your doctor or||
4269|078|S|pharmacist.||
4269|079|S|   In the US -||
4269|080|S|   Call your doctor for medical advice about side effects. You||
4269|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4269|082|S|www.fda.gov/medwatch.||
4269|083|S|   In Canada - Call your doctor for medical advice about side||
4269|084|S|effects. You may report side effects to Health Canada at||
4269|085|S|1-866-234-2345.||
4269|086|B|||
4269|087|P|PRECAUTIONS:  Before taking cefdinir, tell your doctor or||
4269|088|P|pharmacist if you are allergic to it; or to penicillins or other||
4269|089|P|cephalosporin antibiotics (such as cephalexin); or if you have||
4269|090|P|any other allergies. This product may contain inactive||
4269|091|P|ingredients, which can cause allergic reactions or other||
4269|092|P|problems. Talk to your pharmacist for more details.||
4269|093|P|   Before using this medication, tell your doctor or pharmacist||
4269|094|P|your medical history, especially of: kidney disease, intestinal||
4269|095|P|disease (colitis).||
4269|096|P|   Cefdinir may cause live bacterial vaccines (such as typhoid||
4269|097|P|vaccine) to not work well. Tell your health care professional||
4269|098|P|that you are using cefdinir before having any||
4269|099|P|immunizations/vaccinations.||
4269|100|P|   Before having surgery, tell your doctor or dentist about all||
4269|101|P|the products you use (including prescription drugs,||
4269|102|P|nonprescription drugs, and herbal products).||
4269|103|P|   During pregnancy, this medication should be used only when||
4269|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
4269|105|P|   This drug does not pass into breast milk. Consult your doctor||
4269|106|P|before breastfeeding.||
4269|107|B|||
4269|108|I|DRUG INTERACTIONS:  See also How to Use section.||
4269|109|I|   Drug interactions may change how your medications work or||
4269|110|I|increase your risk for serious side effects. This document does||
4269|111|I|not contain all possible drug interactions. Keep a list of all||
4269|112|I|the products you use (including prescription/nonprescription||
4269|113|I|drugs and herbal products) and share it with your doctor and||
4269|114|I|pharmacist. Do not start, stop, or change the dosage of any||
4269|115|I|medicines without your doctor's approval.||
4269|116|I|   This medication may interfere with certain lab tests (such as||
4269|117|I|certain diabetic urine tests), possibly causing false test||
4269|118|I|results. Make sure lab personnel and all your doctors know you||
4269|119|I|use this drug.||
4269|120|B|||
4269|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4269|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4269|123|O|poison control center right away. US residents can call||
4269|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4269|125|O|Symptoms of overdose may include severe vomiting, seizures.||
4269|126|B|||
4269|127|N|NOTES:  Do not share this medication with others.||
4269|128|N|   This medication has been prescribed for your current condition||
4269|129|N|only. Do not use it later for another infection unless your||
4269|130|N|doctor tells you to.||
4269|131|N|   Lab and/or medical tests (such as kidney function) may be done||
4269|132|N|while you are taking this medication. Keep all medical and lab||
4269|133|N|appointments. Consult your doctor for more details.||
4269|134|B|||
4269|135|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4269|136|D|If it is near the time of the next dose, skip the missed dose.||
4269|137|D|Use your next dose at the regular time. Do not double the dose to||
4269|138|D|catch up.||
4269|139|B|||
4269|140|R|STORAGE:  Store at room temperature away from light and moisture.||
4269|141|R|Do not store in the bathroom. Keep all medications away from||
4269|142|R|children and pets.||
4269|143|R|   Do not flush medications down the toilet or pour them into a||
4269|144|R|drain unless instructed to do so. Properly discard this product||
4269|145|R|when it is expired or no longer needed. Consult your pharmacist||
4269|146|R|or local waste disposal company.||
4269|147|B|||
4269|148|A|Information last revised May 2025.||
4269|149|A|Copyright(c) 2025 First Databank, Inc.||
4269|150|B|||
4273|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4273|002|Z|does NOT have all possible information about this product. This||
4273|003|Z|information does not assure that this product is safe, effective,||
4273|004|Z|or appropriate for you. This information is not individual||
4273|005|Z|medical advice and does not substitute for the advice of your||
4273|006|Z|health care professional. Always ask your health care||
4273|007|Z|professional for complete information about this product and your||
4273|008|Z|specific health needs.||
4273|009|B|||
4273|010|T|TRASTUZUMAB - INJECTION||
4273|011|F|(tras-TOOZ-ue-mab)||
4273|012|B|||
4273|013|C|COMMON BRAND NAME(S): Herceptin, Hercessi, Herzuma, Kanjinti,||
4273|014|C|Ogivri, Trazimera||
4273|015|B|||
4273|016|W|WARNING:  Trastuzumab may cause serious heart problems, including||
4273|017|W|heart failure. The risk of heart problems is increased if you||
4273|018|W|also use an anthracycline (such as doxorubicin). Your doctor may||
4273|019|W|stop treatment with this medication if heart problems occur.||
4273|020|W|   Reactions may happen with your injection, usually during or||
4273|021|W|within 24 hours of the dose. Careful monitoring may decrease your||
4273|022|W|risk. Tell your health care professional right away if you have||
4273|023|W|symptoms such as fever, chills, flushing, headache,||
4273|024|W|nausea/vomiting, trouble breathing, dizziness, weakness, or||
4273|025|W|feeling faint. Your doctor may slow down or temporarily stop your||
4273|026|W|injection.||
4273|027|W|   Trastuzumab can cause serious (possibly fatal) harm to an||
4273|028|W|unborn baby if used during pregnancy. Discuss reliable forms of||
4273|029|W|birth control with your doctor.||
4273|030|B|||
4273|031|U|USES:  Trastuzumab is used to treat certain types of breast,||
4273|032|U|stomach, or esophagus cancer. Trastuzumab belongs to a class of||
4273|033|U|medications known as monoclonal antibodies. It works by slowing||
4273|034|U|or stopping the growth of cancer cells.||
4273|035|U|   This monograph is about the following trastuzumab products:||
4273|036|U|trastuzumab, trastuzumab-anns, trastuzumab-dkst,||
4273|037|U|trastuzumab-dttb, trastuzumab-pkrb, trastuzumab-qyyp,||
4273|038|U|trastuzumab-strf.||
4273|039|B|||
4273|040|H|HOW TO USE:  This medication is given by slow injection into a||
4273|041|H|vein by a health care professional, usually once every week or||
4273|042|H|once every 3 weeks. The first injection is given over at least 90||
4273|043|H|minutes.||
4273|044|H|   The dosage is based on your medical condition, response to||
4273|045|H|treatment, weight, and other medications you may be taking. Be||
4273|046|H|sure to tell your doctor and pharmacist about all the products||
4273|047|H|you use (including prescription drugs, nonprescription drugs, and||
4273|048|H|herbal products).||
4273|049|H|   Use this medication regularly to get the most benefit from it.||
4273|050|H|To help you remember, mark your calendar with a reminder.||
4273|051|H|   Your doctor may prescribe other medications (such as||
4273|052|H|acetaminophen, diphenhydramine) for you to take before each dose||
4273|053|H|to help prevent serious side effects. Follow your doctor's||
4273|054|H|directions carefully.||
4273|055|B|||
4273|056|S|SIDE EFFECTS:  See also Warning section.||
4273|057|S|   Redness/irritation at the injection site, diarrhea,||
4273|058|S|muscle/joint/back pain, stomach/abdominal pain, headache, trouble||
4273|059|S|sleeping, nausea, vomiting, mouth sores, and loss of appetite may||
4273|060|S|occur. Nausea and vomiting can be severe. In some cases, your||
4273|061|S|doctor may prescribe medication to prevent or relieve nausea and||
4273|062|S|vomiting. Eating several small meals, not eating before||
4273|063|S|treatment, or limiting activity may help lessen some of these||
4273|064|S|effects. If any of these effects last or get worse, tell your||
4273|065|S|doctor or pharmacist promptly.||
4273|066|S|   Remember that this medication has been prescribed because your||
4273|067|S|doctor has judged that the benefit to you is greater than the||
4273|068|S|risk of side effects. Many people using this medication do not||
4273|069|S|have serious side effects.||
4273|070|S|   Tell your doctor right away if you have any serious side||
4273|071|S|effects, including: symptoms of heart failure (such as shortness||
4273|072|S|of breath, swelling ankles/feet, unusual tiredness,||
4273|073|S|unusual/sudden weight gain), bone pain, numbness/tingling,||
4273|074|S|mental/mood changes, fast/irregular heartbeat, easy||
4273|075|S|bruising/bleeding.||
4273|076|S|   Get medical help right away if you have any very serious side||
4273|077|S|effects, including: chest pain, weakness on one side of the body,||
4273|078|S|trouble speaking, vision changes, confusion.||
4273|079|S|   This medication may lower your ability to fight infections.||
4273|080|S|This may make you more likely to get a serious (rarely fatal)||
4273|081|S|infection or make any infection you have worse. Tell your doctor||
4273|082|S|right away if you have any signs of infection (such as sore||
4273|083|S|throat that doesn't go away, fever, chills).||
4273|084|S|   Trastuzumab can commonly cause a rash that is usually not||
4273|085|S|serious. However, you may not be able to tell it apart from a||
4273|086|S|rare rash that could be a sign of a severe reaction. Tell your||
4273|087|S|doctor right away if you develop any rash.||
4273|088|S|   A very serious allergic reaction to this drug is rare.||
4273|089|S|However, get medical help right away if you notice any symptoms||
4273|090|S|of a serious allergic reaction, including: rash, itching/swelling||
4273|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4273|092|S|breathing.||
4273|093|S|   This is not a complete list of possible side effects. If you||
4273|094|S|notice other effects not listed above, contact your doctor or||
4273|095|S|pharmacist.||
4273|096|S|   In the US -||
4273|097|S|   Call your doctor for medical advice about side effects. You||
4273|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4273|099|S|www.fda.gov/medwatch.||
4273|100|S|   In Canada - Call your doctor for medical advice about side||
4273|101|S|effects. You may report side effects to Health Canada at||
4273|102|S|1-866-234-2345.||
4273|103|B|||
4273|104|P|PRECAUTIONS:  See also Warning section.||
4273|105|P|   Before using trastuzumab, tell your doctor or pharmacist if||
4273|106|P|you are allergic to it; or to any trastuzumab, trastuzumab||
4273|107|P|deruxtecan, trastuzumab emtansine, or trastuzumab-hyaluronidase||
4273|108|P|products; or if you have any other allergies. This product may||
4273|109|P|contain inactive ingredients, which can cause allergic reactions||
4273|110|P|or other problems. Talk to your pharmacist for more details.||
4273|111|P|   Before using this medication, tell your doctor or pharmacist||
4273|112|P|your medical history, especially of: current/recent infection,||
4273|113|P|heart disease, lung problems, previous cancer treatments||
4273|114|P|(including radiation treatment).||
4273|115|P|   Trastuzumab can make you more likely to get infections or may||
4273|116|P|make current infections worse. Stay away from anyone who has an||
4273|117|P|infection that may easily spread (such as chickenpox, COVID-19,||
4273|118|P|measles, flu). Talk to your doctor if you have been exposed to an||
4273|119|P|infection or for more details.||
4273|120|P|   Tell your health care professional that you are using||
4273|121|P|trastuzumab before having any immunizations/vaccinations. Avoid||
4273|122|P|contact with people who have recently received live vaccines||
4273|123|P|(such as flu vaccine inhaled through the nose).||
4273|124|P|   To lower the chance of getting cut, bruised, or injured, use||
4273|125|P|caution with sharp objects like razors and nail cutters, and||
4273|126|P|avoid activities such as contact sports.||
4273|127|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4273|128|P|can make you more dizzy. Do not drive, use machinery, or do||
4273|129|P|anything that needs alertness until you can do it safely. Limit||
4273|130|P|alcoholic beverages. Talk to your doctor if you are using||
4273|131|P|marijuana (cannabis).||
4273|132|P|   Before having surgery, tell your doctor or dentist about all||
4273|133|P|the products you use (including prescription drugs,||
4273|134|P|nonprescription drugs, and herbal products).||
4273|135|P|   Older adults may be at greater risk for heart problems (such||
4273|136|P|as heart failure) while using this drug.||
4273|137|P|   Tell your doctor if you are pregnant or plan to become||
4273|138|P|pregnant. You should not become pregnant while using trastuzumab.||
4273|139|P|Trastuzumab may harm an unborn baby. Your doctor should order a||
4273|140|P|pregnancy test before you start this medication. Ask about||
4273|141|P|reliable forms of birth control while using this medication and||
4273|142|P|for 7 months after the last dose. If you become pregnant, talk to||
4273|143|P|your doctor right away about the risks and benefits of this||
4273|144|P|medication.||
4273|145|P|   It is unknown if this drug passes into breast milk. Consult||
4273|146|P|your doctor before breastfeeding while using this medication and||
4273|147|P|for 7 months after stopping treatment.||
4273|148|B|||
4273|149|I|DRUG INTERACTIONS:  See also Warning section.||
4273|150|I|   Drug interactions may change how your medications work or||
4273|151|I|increase your risk for serious side effects. This document does||
4273|152|I|not contain all possible drug interactions. Keep a list of all||
4273|153|I|the products you use (including prescription/nonprescription||
4273|154|I|drugs and herbal products) and share it with your doctor and||
4273|155|I|pharmacist. Do not start, stop, or change the dosage of any||
4273|156|I|medicines without your doctor's approval.||
4273|157|I|   Trastuzumab is very similar to trastuzumab deruxtecan,||
4273|158|I|trastuzumab emtansine, and trastuzumab-hyaluronidase. Do not use||
4273|159|I|a trastuzumab deruxtecan, trastuzumab emtansine, or||
4273|160|I|trastuzumab-hyaluronidase product while using a trastuzumab||
4273|161|I|product.||
4273|162|B|||
4273|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4273|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4273|165|O|poison control center right away. US residents can call||
4273|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4273|167|B|||
4273|168|N|NOTES:  Lab and/or medical tests (such as heart exams, complete||
4273|169|N|blood count) should be done before you start using this||
4273|170|N|medication and while you are using it. Keep all medical and lab||
4273|171|N|appointments.||
4273|172|B|||
4273|173|D|MISSED DOSE:  It is important to get each dose of this medication||
4273|174|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
4273|175|D|right away for a new dosing schedule.||
4273|176|B|||
4273|177|R|STORAGE:  Not applicable. This medication is given in a hospital||
4273|178|R|or clinic and will not be stored at home.||
4273|179|B|||
4273|180|M|MEDICAL ALERT:  Your condition can cause complications in a||
4273|181|M|medical emergency. For information about enrolling in MedicAlert,||
4273|182|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4273|183|B|||
4273|184|A|Information last revised May 2025.||
4273|185|A|Copyright(c) 2025 First Databank, Inc.||
4273|186|B|||
4274|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4274|002|Z|does NOT have all possible information about this product. This||
4274|003|Z|information does not assure that this product is safe, effective,||
4274|004|Z|or appropriate for you. This information is not individual||
4274|005|Z|medical advice and does not substitute for the advice of your||
4274|006|Z|health care professional. Always ask your health care||
4274|007|Z|professional for complete information about this product and your||
4274|008|Z|specific health needs.||
4274|009|B|||
4274|010|T|ARIPIPRAZOLE - ORAL||
4274|011|F|(AR-i-PIP-ra-zole)||
4274|012|B|||
4274|013|C|COMMON BRAND NAME(S): Abilify||
4274|014|B|||
4274|015|W|WARNING:  If you are using aripiprazole in combination with other||
4274|016|W|medication to treat depression, also carefully read the drug||
4274|017|W|information for the other medication.||
4274|018|W|   There may be a slightly increased risk of serious, possibly||
4274|019|W|fatal side effects (such as stroke, heart failure, fast/irregular||
4274|020|W|heartbeat, pneumonia) when this medication is used by older||
4274|021|W|adults with dementia. This medication is not approved for the||
4274|022|W|treatment of dementia-related behavior problems. Discuss the||
4274|023|W|risks and benefits of this medication, as well as other effective||
4274|024|W|and possibly safer treatments for dementia-related behavior||
4274|025|W|problems, with the doctor.||
4274|026|B|||
4274|027|U|USES:  This medication is used to treat certain mental/mood||
4274|028|U|disorders (such as bipolar disorder, schizophrenia, Tourette's||
4274|029|U|syndrome, and irritability associated with autistic disorder). It||
4274|030|U|may also be used in combination with other medication to treat||
4274|031|U|depression. Aripiprazole belongs to a class of drugs known as||
4274|032|U|atypical antipsychotics. It works by helping to restore the||
4274|033|U|balance of certain natural substances in the brain.||
4274|034|B|||
4274|035|V|OTHER USES:  This section contains uses of this drug that are not||
4274|036|V|listed in the approved professional labeling for the drug but||
4274|037|V|that may be prescribed by your health care professional. Use this||
4274|038|V|drug for a condition that is listed in this section only if it||
4274|039|V|has been so prescribed by your health care professional.||
4274|040|V|   This medication may also be used for obsessive-compulsive||
4274|041|V|disorder.||
4274|042|B|||
4274|043|H|HOW TO USE:  Read the Medication Guide and, if available, the||
4274|044|H|Patient Information Leaflet provided by your pharmacist before||
4274|045|H|you start taking aripiprazole and each time you get a refill. If||
4274|046|H|you have any questions, ask your doctor or pharmacist.||
4274|047|H|   Take this medication by mouth with or without food as directed||
4274|048|H|by your doctor, usually once daily. The dosage is based on your||
4274|049|H|medical condition, response to treatment, age, and other||
4274|050|H|medications you may be taking. Be sure to tell your doctor and||
4274|051|H|pharmacist about all the products you use (including prescription||
4274|052|H|drugs, nonprescription drugs, and herbal products). To reduce||
4274|053|H|your risk of side effects, your doctor may direct you to start||
4274|054|H|this medication at a low dose and gradually increase your dose.||
4274|055|H|Follow your doctor's instructions carefully.||
4274|056|H|   The manufacturer directs to swallow this medication whole.||
4274|057|H|However, many similar drugs (immediate-release tablets) can be||
4274|058|H|split/crushed. Follow your doctor's direction on how to take this||
4274|059|H|medication.||
4274|060|H|   If you are using the liquid form of this medication, carefully||
4274|061|H|measure the dose using a special measuring device/cup. Do not use||
4274|062|H|a household spoon because you may not get the correct dose.||
4274|063|H|   Do not increase your dose or use this drug more often or for||
4274|064|H|longer than prescribed. Your condition will not improve any||
4274|065|H|faster, and your risk of side effects will increase.||
4274|066|H|   It may take several weeks before you get the full benefit of||
4274|067|H|this drug. Use this medication regularly to get the most benefit||
4274|068|H|from it. To help you remember, take it at the same time each day.||
4274|069|H|   Keep taking this medication even if you feel well. Do not stop||
4274|070|H|taking this medication without consulting your doctor. Some||
4274|071|H|conditions may become worse when this drug is suddenly stopped.||
4274|072|H|Your dose may need to be gradually decreased.||
4274|073|H|   Tell your doctor if your condition does not get better or if||
4274|074|H|it gets worse.||
4274|075|B|||
4274|076|S|SIDE EFFECTS:  See also Warning section.||
4274|077|S|   Dizziness, lightheadedness, drowsiness, nausea, vomiting,||
4274|078|S|tiredness, excess saliva/drooling, blurred vision, weight gain,||
4274|079|S|constipation, headache, and trouble sleeping may occur. If any of||
4274|080|S|these effects last or get worse, tell your doctor or pharmacist||
4274|081|S|promptly.||
4274|082|S|   Dizziness and lightheadedness can increase the risk of||
4274|083|S|falling. Get up slowly when rising from a sitting or lying||
4274|084|S|position.||
4274|085|S|   Remember that this medication has been prescribed because your||
4274|086|S|doctor has judged that the benefit to you is greater than the||
4274|087|S|risk of side effects. Many people using this medication do not||
4274|088|S|have serious side effects.||
4274|089|S|   Tell your doctor right away if you have any serious side||
4274|090|S|effects, including: fainting, mental/mood changes (such as||
4274|091|S|increased anxiety, depression, suicidal thoughts), trouble||
4274|092|S|swallowing, restlessness (especially in the legs), shaking||
4274|093|S|(tremor), muscle spasm, mask-like expression of the face,||
4274|094|S|seizures, trouble controlling certain urges (such as gambling,||
4274|095|S|sex, eating or shopping), interrupted breathing during sleep.||
4274|096|S|   This medication may rarely make your blood sugar rise, which||
4274|097|S|can cause or worsen diabetes. Tell your doctor right away if you||
4274|098|S|have symptoms of high blood sugar such as increased||
4274|099|S|thirst/urination. If you already have diabetes, check your blood||
4274|100|S|sugar regularly as directed and share the results with your||
4274|101|S|doctor. Your doctor may need to adjust your diabetes medication,||
4274|102|S|exercise program, or diet.||
4274|103|S|   This medication may rarely cause a condition called tardive||
4274|104|S|dyskinesia. In some cases, this condition may be permanent. Tell||
4274|105|S|your doctor right away if you develop any unusual uncontrolled||
4274|106|S|movements (especially of the face, mouth, tongue, arms, or legs).||
4274|107|S|   This medication may rarely cause a very serious condition||
4274|108|S|called neuroleptic malignant syndrome (NMS). Get medical help||
4274|109|S|right away if you have any of the following symptoms: fever,||
4274|110|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
4274|111|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
4274|112|S|signs of kidney problems (such as change in the amount of urine).||
4274|113|S|   A very serious allergic reaction to this drug is rare.||
4274|114|S|However, get medical help right away if you notice any symptoms||
4274|115|S|of a serious allergic reaction, including: fever, swollen lymph||
4274|116|S|nodes, rash, itching/swelling (especially of the||
4274|117|S|face/tongue/throat), severe dizziness, trouble breathing.||
4274|118|S|   This is not a complete list of possible side effects. If you||
4274|119|S|notice other effects not listed above, contact your doctor or||
4274|120|S|pharmacist.||
4274|121|S|   In the US -||
4274|122|S|   Call your doctor for medical advice about side effects. You||
4274|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4274|124|S|www.fda.gov/medwatch.||
4274|125|S|   In Canada - Call your doctor for medical advice about side||
4274|126|S|effects. You may report side effects to Health Canada at||
4274|127|S|1-866-234-2345.||
4274|128|B|||
4274|129|P|PRECAUTIONS:  See also Warning section.||
4274|130|P|   Before taking aripiprazole, tell your doctor or pharmacist if||
4274|131|P|you are allergic to it; or if you have any other allergies. This||
4274|132|P|product may contain inactive ingredients (such as propylene||
4274|133|P|glycol), which can cause allergic reactions or other problems.||
4274|134|P|Talk to your pharmacist for more details.||
4274|135|P|   Before using this medication, tell your doctor or pharmacist||
4274|136|P|your medical history, especially of: problems with blood flow in||
4274|137|P|the brain (such as cerebrovascular disease, stroke), diabetes||
4274|138|P|(including family history), heart problems (such as low blood||
4274|139|P|pressure, coronary artery disease, heart failure, irregular||
4274|140|P|heartbeat), nervous system problems (such as dementia, NMS,||
4274|141|P|seizures), obesity, low white blood cell count (including history||
4274|142|P|of low white blood cell count caused by medications), swallowing||
4274|143|P|problems, breathing trouble during sleep (sleep apnea).||
4274|144|P|   This drug may make you dizzy or drowsy or blur your vision.||
4274|145|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
4274|146|P|drowsy. Do not drive, use machinery, or do anything that needs||
4274|147|P|alertness or clear vision until you can do it safely. Avoid||
4274|148|P|alcoholic beverages. Talk to your doctor if you are using||
4274|149|P|marijuana (cannabis).||
4274|150|P|   This medication may make you sweat less, making you more||
4274|151|P|likely to get heat stroke. Avoid doing things that may cause you||
4274|152|P|to overheat, such as hard work or exercise in hot weather, or||
4274|153|P|using hot tubs. When the weather is hot, drink a lot of fluids||
4274|154|P|and dress lightly. If you overheat, quickly look for a place to||
4274|155|P|cool down and rest. Get medical help right away if you have a||
4274|156|P|fever that does not go away, mental/mood changes, headache, or||
4274|157|P|dizziness.||
4274|158|P|   Liquid preparations of this product may contain sugar. Caution||
4274|159|P|is advised if you have diabetes. Ask your doctor or pharmacist||
4274|160|P|about using this product safely.||
4274|161|P|   Older adults may be more sensitive to the side effects of this||
4274|162|P|drug, especially seizures, drowsiness, dizziness,||
4274|163|P|lightheadedness, confusion, tardive dyskinesia, swallowing||
4274|164|P|problems, and other serious (rarely fatal) side effects. (See||
4274|165|P|also Warning section.) Drowsiness, dizziness, lightheadedness,||
4274|166|P|and confusion can increase the risk of falling.||
4274|167|P|   Before having surgery, tell your doctor or dentist about all||
4274|168|P|the products you use (including prescription drugs,||
4274|169|P|nonprescription drugs, and herbal products).||
4274|170|P|   During pregnancy, this medication should be used only when||
4274|171|P|clearly needed. Babies born to mothers who have used this drug||
4274|172|P|during the last 3 months of pregnancy may rarely develop symptoms||
4274|173|P|including muscle stiffness or shakiness, drowsiness,||
4274|174|P|feeding/breathing difficulties, or constant crying. If you notice||
4274|175|P|any of these symptoms in your newborn especially during their||
4274|176|P|first month, tell the doctor right away.||
4274|177|P|   Since untreated mental/mood problems (such as bipolar||
4274|178|P|disorder, schizophrenia) can be a serious condition, do not stop||
4274|179|P|taking this medication unless directed by your doctor. If you are||
4274|180|P|planning pregnancy, become pregnant, or think you may be||
4274|181|P|pregnant, immediately discuss with your doctor the benefits and||
4274|182|P|risks of using this medication during pregnancy.||
4274|183|P|   This medication passes into breast milk. Consult your doctor||
4274|184|P|before breastfeeding.||
4274|185|B|||
4274|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4274|187|I|medications work or increase your risk for serious side effects.||
4274|188|I|This document does not contain all possible drug interactions.||
4274|189|I|Keep a list of all the products you use (including||
4274|190|I|prescription/nonprescription drugs and herbal products) and share||
4274|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
4274|192|I|the dosage of any medicines without your doctor's approval.||
4274|193|I|   A product that may interact with this drug is: metoclopramide.||
4274|194|I|   Tell your doctor or pharmacist if you are taking other||
4274|195|I|products that cause drowsiness such as opioid pain or cough||
4274|196|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4274|197|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4274|198|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4274|199|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
4274|200|I|diphenhydramine).||
4274|201|I|   Check the labels on all your medicines (such as allergy or||
4274|202|I|cough-and-cold products) because they may contain ingredients||
4274|203|I|that cause drowsiness. Ask your pharmacist about using those||
4274|204|I|products safely.||
4274|205|B|||
4274|206|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4274|207|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4274|208|O|poison control center right away. US residents can call||
4274|209|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4274|210|O|Symptoms of overdose may include: very fast heartbeat, loss of||
4274|211|O|consciousness.||
4274|212|B|||
4274|213|N|NOTES:  Do not share this medication with others.||
4274|214|N|   Lab and/or medical tests (such as blood sugar, weight,||
4274|215|N|cholesterol/triglyceride levels) may be done before you start||
4274|216|N|taking this medication and while you are taking it. Keep all||
4274|217|N|medical and lab appointments. Consult your doctor for more||
4274|218|N|details.||
4274|219|B|||
4274|220|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4274|221|D|remember. If it is near the time of the next dose, skip the||
4274|222|D|missed dose. Take your next dose at the regular time. Do not||
4274|223|D|double the dose to catch up.||
4274|224|B|||
4274|225|R|STORAGE:  Store at room temperature away from light and moisture.||
4274|226|R|Do not store in the bathroom. For the liquid form, once the||
4274|227|R|bottle is opened, the medication expires after 6 months. Keep all||
4274|228|R|medications away from children and pets.||
4274|229|R|   Do not flush medications down the toilet or pour them into a||
4274|230|R|drain unless instructed to do so. Properly discard this product||
4274|231|R|when it is expired or no longer needed. Consult your pharmacist||
4274|232|R|or local waste disposal company.||
4274|233|B|||
4274|234|A|Information last revised April 2025.||
4274|235|A|Copyright(c) 2025 First Databank, Inc.||
4274|236|B|||
4279|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4279|002|Z|does NOT have all possible information about this product. This||
4279|003|Z|information does not assure that this product is safe, effective,||
4279|004|Z|or appropriate for you. This information is not individual||
4279|005|Z|medical advice and does not substitute for the advice of your||
4279|006|Z|health care professional. Always ask your health care||
4279|007|Z|professional for complete information about this product and your||
4279|008|Z|specific health needs.||
4279|009|B|||
4279|010|T|VALGANCICLOVIR- ORAL||
4279|011|F|(val-gan-SIGH-klow-veer)||
4279|012|B|||
4279|013|C|COMMON BRAND NAME(S): Valcyte||
4279|014|B|||
4279|015|W|WARNING:  Valganciclovir turns into the drug ganciclovir inside||
4279|016|W|your body. Ganciclovir can decrease bone marrow function. This||
4279|017|W|serious, possibly life-threatening side effect may lead to a low||
4279|018|W|number of blood cells such as red cells, white cells, and||
4279|019|W|platelets. This effect can cause anemia, decrease your body's||
4279|020|W|ability to fight an infection, and cause bleeding problems. Your||
4279|021|W|doctor will check the results of your blood tests and adjust your||
4279|022|W|treatment to reduce your risk for these side effects. Get medical||
4279|023|W|help right away if you develop signs of anemia (such as unusual||
4279|024|W|tiredness, fast breathing, pale skin, fast heartbeat), signs of||
4279|025|W|infection (such as sore throat that doesn't go away, fever,||
4279|026|W|chills), and signs of bleeding (such as easy bruising/bleeding,||
4279|027|W|nose bleeds, bleeding gums, bloody/black/tarry stools, vomit that||
4279|028|W|looks like coffee grounds).||
4279|029|W|   Ganciclovir may reduce fertility in men and women. It may also||
4279|030|W|harm an unborn baby. Talk to your doctor for more details.||
4279|031|W|   Ganciclovir has caused tumors in lab animals. Although there||
4279|032|W|is no information in humans, valganciclovir should be considered||
4279|033|W|cancer-causing (carcinogenic). See also How to Use and||
4279|034|W|Precautions sections.||
4279|035|B|||
4279|036|U|USES:  Valganciclovir is an anti-viral drug. It is changed in the||
4279|037|U|body to the active form of the drug called ganciclovir. It is||
4279|038|U|used to prevent disease caused by a virus called cytomegalovirus||
4279|039|U|(CMV) in people who have received organ transplants. CMV disease||
4279|040|U|can lead to serious infections in the body, including an||
4279|041|U|infection in the eye, called CMV retinitis, that can cause||
4279|042|U|blindness. Valganciclovir works by slowing the growth of the CMV||
4279|043|U|virus. It helps prevent the spread of infection to other areas of||
4279|044|U|the body.||
4279|045|U|   Valganciclovir is also used to treat CMV retinitis in people||
4279|046|U|with advanced HIV disease (AIDS). This medication helps control||
4279|047|U|CMV retinitis and decrease the risk of blindness.||
4279|048|U|   Valganciclovir is not a cure for CMV disease. Some people may||
4279|049|U|have worsening CMV retinitis even with treatment. It is important||
4279|050|U|to have your eyes checked regularly by your doctor.||
4279|051|B|||
4279|052|V|OTHER USES:  This section contains uses of this drug that are not||
4279|053|V|listed in the approved professional labeling for the drug but||
4279|054|V|that may be prescribed by your health care professional. Use this||
4279|055|V|drug for a condition that is listed in this section only if it||
4279|056|V|has been so prescribed by your health care professional.||
4279|057|V|   This drug may also be used to reduce the risk of CMV disease||
4279|058|V|in people receiving cancer chemotherapy treatment.||
4279|059|B|||
4279|060|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4279|061|H|from your pharmacist before you start taking valganciclovir and||
4279|062|H|each time you get a refill. If you have any questions, ask your||
4279|063|H|doctor or pharmacist.||
4279|064|H|   Take this medication by mouth with food as directed by your||
4279|065|H|doctor, usually 1 to 2 times a day. Swallow the tablets whole. Do||
4279|066|H|not crush or break the tablets.||
4279|067|H|   If you are using the liquid form of this medication, shake the||
4279|068|H|bottle well before each dose. Carefully measure the dose using||
4279|069|H|the special measuring device provided. Do not use a household||
4279|070|H|spoon because you may not get the correct dose.||
4279|071|H|   Wash your hands well after handling this drug. Avoid contact||
4279|072|H|with broken/crushed tablets and the liquid form of this||
4279|073|H|medication on your skin, in your mucous membranes and eyes, and||
4279|074|H|avoid breathing in the dust from the tablets. If contact should||
4279|075|H|occur, wash the area thoroughly with soap and water. If this||
4279|076|H|medication gets in your eyes, rinse them thoroughly with plain||
4279|077|H|water.||
4279|078|H|   The dosage and length of treatment is based on your medical||
4279|079|H|condition. Children's dosage is also based on body size. The||
4279|080|H|doctor should keep track of your child's height and weight to||
4279|081|H|make sure that the dose is right for them.||
4279|082|H|   This medication works best when the amount of drug in your||
4279|083|H|body is kept at a constant level. Take this drug at evenly spaced||
4279|084|H|intervals. To help you remember, take it at the same time(s) each||
4279|085|H|day.||
4279|086|H|   Keep taking this medication exactly as prescribed by your||
4279|087|H|doctor. Do not change your dose or stop taking it even for a||
4279|088|H|short time unless directed to do so by your doctor. Changing or||
4279|089|H|skipping your dose without approval from your doctor may increase||
4279|090|H|the risk of side effects or make the infection worse.||
4279|091|H|   Do not take ganciclovir instead of valganciclovir on your own||
4279|092|H|without consulting your doctor or pharmacist. The effects and the||
4279|093|H|dosages of ganciclovir and valganciclovir are not equal.||
4279|094|H|   Tell your doctor if your condition gets worse (such as||
4279|095|H|worsening vision).||
4279|096|B|||
4279|097|S|SIDE EFFECTS:  See also Warning section.||
4279|098|S|   Diarrhea, upset stomach, dizziness, drowsiness, unsteadiness,||
4279|099|S|or shaking (tremors) may occur. If any of these effects last or||
4279|100|S|get worse, tell your doctor or pharmacist promptly.||
4279|101|S|   Remember that this medication has been prescribed because your||
4279|102|S|doctor has judged that the benefit to you is greater than the||
4279|103|S|risk of side effects. Many people using this medication do not||
4279|104|S|have serious side effects.||
4279|105|S|   Tell your doctor right away if you have any serious side||
4279|106|S|effects, including: mental/mood changes (such as confusion,||
4279|107|S|hallucinations), signs of kidney problems (such as change in the||
4279|108|S|amount of urine), seizures.||
4279|109|S|   A very serious allergic reaction to this drug is rare.||
4279|110|S|However, get medical help right away if you notice any symptoms||
4279|111|S|of a serious allergic reaction, including: rash, itching/swelling||
4279|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4279|113|S|breathing.||
4279|114|S|   This is not a complete list of possible side effects. If you||
4279|115|S|notice other effects not listed above, contact your doctor or||
4279|116|S|pharmacist.||
4279|117|S|   In the US -||
4279|118|S|   Call your doctor for medical advice about side effects. You||
4279|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4279|120|S|www.fda.gov/medwatch.||
4279|121|S|   In Canada - Call your doctor for medical advice about side||
4279|122|S|effects. You may report side effects to Health Canada at||
4279|123|S|1-866-234-2345.||
4279|124|B|||
4279|125|P|PRECAUTIONS:  Before taking valganciclovir, tell your doctor or||
4279|126|P|pharmacist if you are allergic to it; or to ganciclovir or||
4279|127|P|acyclovir; or if you have any other allergies. This product may||
4279|128|P|contain inactive ingredients, which can cause allergic reactions||
4279|129|P|or other problems. Talk to your pharmacist for more details.||
4279|130|P|   Before using this medication, tell your doctor or pharmacist||
4279|131|P|your medical history, especially of: kidney problems (such as||
4279|132|P|kidney dialysis), a low number of blood cells (red or white blood||
4279|133|P|cells, platelets), radiation treatment.||
4279|134|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4279|135|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4279|136|P|machinery, or do anything that needs alertness until you can do||
4279|137|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
4279|138|P|are using marijuana (cannabis).||
4279|139|P|   Valganciclovir can make you more likely to get infections or||
4279|140|P|may make current infections worse. Stay away from anyone who has||
4279|141|P|an infection that may easily spread (such as chickenpox,||
4279|142|P|COVID-19, measles, flu). Talk to your doctor if you have been||
4279|143|P|exposed to an infection or for more details.||
4279|144|P|   Tell your health care professional that you are using||
4279|145|P|valganciclovir before having any immunizations/vaccinations.||
4279|146|P|Avoid contact with people who have recently received live||
4279|147|P|vaccines (such as flu vaccine inhaled through the nose).||
4279|148|P|   To lower the chance of getting cut, bruised, or injured, use||
4279|149|P|caution with sharp objects like razors and nail cutters, and||
4279|150|P|avoid activities such as contact sports.||
4279|151|P|   Older adults may be at greater risk for kidney problems while||
4279|152|P|using this drug.||
4279|153|P|   Women who are pregnant or who may become pregnant should not||
4279|154|P|handle this medication.||
4279|155|P|   During pregnancy, this medication should be used only when||
4279|156|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
4279|157|P|benefits with your doctor. Women of childbearing age should have||
4279|158|P|a pregnancy test before starting this medication. To prevent||
4279|159|P|pregnancy, men with female partners should always use effective||
4279|160|P|barrier protection (such as latex or polyurethane condoms) during||
4279|161|P|all sexual activity during treatment and for at least 90 days||
4279|162|P|after stopping the medication. Women of childbearing age who are||
4279|163|P|taking valganciclovir should use reliable forms of birth control||
4279|164|P|(such as birth control pills and condoms) during treatment and||
4279|165|P|for at least 30 days after stopping the medication. Consult your||
4279|166|P|doctor for more details.||
4279|167|P|   It is unknown if this medication passes into breast milk.||
4279|168|P|Because of the possible risk to the infant, breastfeeding is not||
4279|169|P|recommended while using this medication. Consult your doctor||
4279|170|P|before breastfeeding.||
4279|171|B|||
4279|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4279|173|I|medications work or increase your risk for serious side effects.||
4279|174|I|This document does not contain all possible drug interactions.||
4279|175|I|Keep a list of all the products you use (including||
4279|176|I|prescription/nonprescription drugs and herbal products) and share||
4279|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
4279|178|I|the dosage of any medicines without your doctor's approval.||
4279|179|I|   Some products that may interact with this drug include:||
4279|180|I|imipenem/cilastatin, maribavir.||
4279|181|I|   You may be taking other drugs that decrease bone marrow||
4279|182|I|function and lower your number of blood cells (such as cancer||
4279|183|I|chemotherapy, trimethoprim/sulfamethoxazole, zidovudine) or other||
4279|184|I|drugs that may cause kidney problems (such as cyclosporine). Your||
4279|185|I|doctor or pharmacist will monitor you closely and adjust your||
4279|186|I|medications to decrease your risk of serious side effects.||
4279|187|I|   Valganciclovir is very similar to ganciclovir. Do not use||
4279|188|I|medications containing ganciclovir while using valganciclovir.||
4279|189|B|||
4279|190|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4279|191|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4279|192|O|poison control center right away. US residents can call||
4279|193|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4279|194|B|||
4279|195|N|NOTES:  Do not share this medication with others.||
4279|196|N|   Lab and/or medical tests (such as complete blood count, kidney||
4279|197|N|function, eye exams) should be done while you are taking this||
4279|198|N|medication. Keep all medical and lab appointments. Consult your||
4279|199|N|doctor for more details.||
4279|200|B|||
4279|201|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4279|202|D|remember. If it is near the time of the next dose, skip the||
4279|203|D|missed dose. Take your next dose at the regular time. Do not||
4279|204|D|double the dose to catch up.||
4279|205|B|||
4279|206|R|STORAGE:  Store the tablets at room temperature away from light||
4279|207|R|and moisture. Do not store in the bathroom.||
4279|208|R|   Store the liquid form of this medication in the refrigerator.||
4279|209|R|Do not freeze. The medication expires 49 days after it was||
4279|210|R|prepared by the pharmacy.||
4279|211|R|   Keep all medications away from children and pets.||
4279|212|R|   Do not flush medications down the toilet or pour them into a||
4279|213|R|drain unless instructed to do so. Properly discard this product||
4279|214|R|when it is expired or no longer needed. Consult your pharmacist||
4279|215|R|or local waste disposal company.||
4279|216|B|||
4279|217|A|Information last revised May 2025.||
4279|218|A|Copyright(c) 2025 First Databank, Inc.||
4279|219|B|||
4281|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4281|002|Z|does NOT have all possible information about this product. This||
4281|003|Z|information does not assure that this product is safe, effective,||
4281|004|Z|or appropriate for you. This information is not individual||
4281|005|Z|medical advice and does not substitute for the advice of your||
4281|006|Z|health care professional. Always ask your health care||
4281|007|Z|professional for complete information about this product and your||
4281|008|Z|specific health needs.||
4281|009|B|||
4281|010|T|QUINAPRIL/HYDROCHLOROTHIAZIDE - ORAL||
4281|011|F|(KWIN-a-pril/HYE-droe-KLOR-oh-THYE-a-zide)||
4281|012|B|||
4281|013|C|COMMON BRAND NAME(S): Accuretic||
4281|014|B|||
4281|015|W|WARNING:  Quinapril can cause serious (possibly fatal) harm to an||
4281|016|W|unborn baby if used during pregnancy. It is important to prevent||
4281|017|W|pregnancy while taking this product. Consult your doctor for more||
4281|018|W|details and to discuss the use of reliable forms of birth control||
4281|019|W|while taking this product. If you are planning pregnancy, become||
4281|020|W|pregnant, or think you may be pregnant, tell your doctor right||
4281|021|W|away.||
4281|022|B|||
4281|023|U|USES:  This product is used to treat high blood pressure.||
4281|024|U|Lowering high blood pressure helps prevent strokes, heart||
4281|025|U|attacks, and kidney problems.||
4281|026|U|   This product contains 2 medications: quinapril and||
4281|027|U|hydrochlorothiazide. Quinapril belongs to a class of drugs known||
4281|028|U|as ACE inhibitors and works by relaxing blood vessels so blood||
4281|029|U|can flow more easily. Hydrochlorothiazide belongs to a class of||
4281|030|U|drugs known as diuretics/"water pills." It works by causing you||
4281|031|U|to make more urine. This helps your body get rid of extra salt||
4281|032|U|and water.||
4281|033|B|||
4281|034|V|OTHER USES:  This section contains uses of this drug that are not||
4281|035|V|listed in the approved professional labeling for the drug but||
4281|036|V|that may be prescribed by your health care professional. Use this||
4281|037|V|drug for a condition that is listed in this section only if it||
4281|038|V|has been so prescribed by your health care professional.||
4281|039|V|   This drug may also be used for heart failure.||
4281|040|B|||
4281|041|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4281|042|H|from your pharmacist before you start taking||
4281|043|H|quinapril/hydrochlorothiazide and each time you get a refill. If||
4281|044|H|you have any questions, ask your doctor or pharmacist.||
4281|045|H|   Take this medication by mouth with or without food as directed||
4281|046|H|by your doctor, usually once daily in the morning. If you take||
4281|047|H|this drug too close to bedtime, you may need to wake up to||
4281|048|H|urinate. It is best to take this medication at least 4 hours||
4281|049|H|before your bedtime.||
4281|050|H|   The dosage is based on your medical condition and response to||
4281|051|H|treatment.||
4281|052|H|   Take this medication regularly to get the most benefit from||
4281|053|H|it. To help you remember, take it at the same time each day. Keep||
4281|054|H|taking this medication even if you feel well. Most people with||
4281|055|H|high blood pressure do not feel sick.||
4281|056|H|   It may take several weeks before you get the full benefit of||
4281|057|H|this product.||
4281|058|H|   This product contains magnesium which may interfere with the||
4281|059|H|absorption of some medications. See the Drug Interactions section||
4281|060|H|and consult your pharmacist for more information.||
4281|061|H|   If you also take certain drugs to lower your cholesterol (bile||
4281|062|H|acid-binding resins such as cholestyramine or colestipol), take||
4281|063|H|this product at least 4 hours before or at least 4 to 6 hours||
4281|064|H|after these medications.||
4281|065|H|   Tell your doctor if your condition does not get better or if||
4281|066|H|it gets worse (your blood pressure readings remain high or||
4281|067|H|increase).||
4281|068|B|||
4281|069|S|SIDE EFFECTS:  Tiredness, headache, dizziness, or lightheadedness||
4281|070|S|may occur as your body adjusts to the medication. Dry cough may||
4281|071|S|also occur. If any of these effects last or get worse, tell your||
4281|072|S|doctor or pharmacist promptly.||
4281|073|S|   To reduce the risk of dizziness and lightheadedness, get up||
4281|074|S|slowly when rising from a sitting or lying position.||
4281|075|S|   Remember that this medication has been prescribed because your||
4281|076|S|doctor has judged that the benefit to you is greater than the||
4281|077|S|risk of side effects. Many people using this medication do not||
4281|078|S|have serious side effects.||
4281|079|S|   This product may cause dehydration and electrolyte imbalance.||
4281|080|S|Tell your doctor right away if you have any symptoms of||
4281|081|S|dehydration or electrolyte imbalance, including unusual dry||
4281|082|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
4281|083|S|heartbeat, or confusion.||
4281|084|S|   Tell your doctor right away if you have any serious side||
4281|085|S|effects, including: signs of kidney problems (such as change in||
4281|086|S|the amount of urine), fainting, decrease in vision, eye pain.||
4281|087|S|   This drug may rarely cause serious (possibly fatal) liver||
4281|088|S|problems. Get medical help right away if you have any symptoms of||
4281|089|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
4281|090|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
4281|091|S|urine.||
4281|092|S|   A very serious allergic reaction to this drug is rare.||
4281|093|S|However, get medical help right away if you notice any symptoms||
4281|094|S|of a serious allergic reaction, including: rash, itching/swelling||
4281|095|S|(especially of the face/tongue/throat/neck), severe dizziness,||
4281|096|S|trouble breathing.||
4281|097|S|   This is not a complete list of possible side effects. If you||
4281|098|S|notice other effects not listed above, contact your doctor or||
4281|099|S|pharmacist.||
4281|100|S|   In the US -||
4281|101|S|   Call your doctor for medical advice about side effects. You||
4281|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4281|103|S|www.fda.gov/medwatch.||
4281|104|S|   In Canada - Call your doctor for medical advice about side||
4281|105|S|effects. You may report side effects to Health Canada at||
4281|106|S|1-866-234-2345.||
4281|107|B|||
4281|108|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
4281|109|P|pharmacist if you are allergic to either quinapril or||
4281|110|P|hydrochlorothiazide; or to other ACE inhibitors (such as||
4281|111|P|captopril, lisinopril); or to thiazides (such as chlorothiazide);||
4281|112|P|or if you have any other allergies. This product may contain||
4281|113|P|inactive ingredients, which can cause allergic reactions or other||
4281|114|P|problems. Talk to your pharmacist for more details.||
4281|115|P|   Before using this medication, tell your doctor or pharmacist||
4281|116|P|your medical history, especially of: history of an allergic||
4281|117|P|reaction which included swelling of the face/lips/tongue/throat||
4281|118|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
4281|119|P|dialysis), gout, kidney problems, liver disease, dehydration,||
4281|120|P|untreated mineral imbalances (such as high or low potassium),||
4281|121|P|lupus, skin cancer.||
4281|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4281|123|P|can make you more dizzy. Do not drive, use machinery, or do||
4281|124|P|anything that needs alertness until you can do it safely. Limit||
4281|125|P|alcoholic beverages. Talk to your doctor if you are using||
4281|126|P|marijuana (cannabis).||
4281|127|P|   Before having surgery, tell your doctor or dentist about all||
4281|128|P|the products you use (including prescription drugs,||
4281|129|P|nonprescription drugs, and herbal products).||
4281|130|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
4281|131|P|and cause you to feel lightheaded. Tell your doctor if you have||
4281|132|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
4281|133|P|of fluids unless your doctor tells you not to.||
4281|134|P|   This medication may make you more sensitive to the sun. It may||
4281|135|P|also increase your risk for skin cancer, especially if you take||
4281|136|P|it for a long time. Limit your time in the sun. Avoid tanning||
4281|137|P|booths and sunlamps. Use sunscreen and wear protective clothing||
4281|138|P|when outdoors. Tell your doctor right away if you get sunburned,||
4281|139|P|have skin blisters/redness, or notice new or changed moles/skin||
4281|140|P|lesions.||
4281|141|P|   This product may affect your potassium levels. Before using||
4281|142|P|potassium supplements or salt substitutes containing potassium,||
4281|143|P|consult your doctor or pharmacist.||
4281|144|P|   If you have diabetes, this product may affect your blood||
4281|145|P|sugar. Check your blood sugar regularly as directed and share the||
4281|146|P|results with your doctor. Tell your doctor right away if you have||
4281|147|P|symptoms of high blood sugar such as increased thirst/urination.||
4281|148|P|Your doctor may need to adjust your diabetes medication, exercise||
4281|149|P|program, or diet.||
4281|150|P|   Older adults may be more sensitive to the side effects of this||
4281|151|P|drug, especially change in the amount of urine (kidney problems)||
4281|152|P|and dizziness.||
4281|153|P|   Tell your doctor if you are pregnant or plan to become||
4281|154|P|pregnant. You should not become pregnant while using this||
4281|155|P|product. Quinapril may harm an unborn baby. If you become||
4281|156|P|pregnant, talk to your doctor right away about the risks and||
4281|157|P|benefits of this medication. (See also Warning section.)||
4281|158|P|   This medication passes into breast milk. Consult your doctor||
4281|159|P|before breastfeeding.||
4281|160|B|||
4281|161|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
4281|162|I|   Drug interactions may change how your medications work or||
4281|163|I|increase your risk for serious side effects. This document does||
4281|164|I|not contain all possible drug interactions. Keep a list of all||
4281|165|I|the products you use (including prescription/nonprescription||
4281|166|I|drugs and herbal products) and share it with your doctor and||
4281|167|I|pharmacist. Do not start, stop, or change the dosage of any||
4281|168|I|medicines without your doctor's approval.||
4281|169|I|   Some products that may interact with this drug are: aliskiren,||
4281|170|I|dofetilide, lithium, gold injections, sacubitril, certain drugs||
4281|171|I|that weaken the immune system/increase the risk of infection||
4281|172|I|(such as everolimus, sirolimus), drugs that may increase the||
4281|173|I|level of potassium in the blood (such as ARBs including||
4281|174|I|losartan/valsartan, birth control pills containing drospirenone).||
4281|175|I|   This product contains magnesium which can interfere with your||
4281|176|I|body's ability to absorb certain drugs, especially if you take||
4281|177|I|them around the same time. These drugs include quinolone||
4281|178|I|antibiotics (such as ciprofloxacin, levofloxacin), tetracycline||
4281|179|I|antibiotics (such as doxycycline, minocycline), thyroid||
4281|180|I|medications (such as levothyroxine), and drugs for osteoporosis||
4281|181|I|(bisphosphonates such as alendronate). This is not a complete||
4281|182|I|list. Ask your doctor or pharmacist how long to wait between||
4281|183|I|doses and when you should take your medications.||
4281|184|I|   Some products have ingredients that could raise your blood||
4281|185|I|pressure. Tell your pharmacist what products you are using, and||
4281|186|I|ask how to use them safely (especially cough-and-cold products,||
4281|187|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
4281|188|I|   A very serious reaction may occur if you are getting||
4281|189|I|injections for bee/wasp sting allergy (desensitization) and are||
4281|190|I|also taking quinapril/hydrochlorothiazide. Make sure all your||
4281|191|I|doctors know which medicines you are using.||
4281|192|I|   This product may interfere with certain lab tests (such as||
4281|193|I|parathyroid function), possibly causing false test results. Make||
4281|194|I|sure lab personnel and all your doctors know you use this||
4281|195|I|product.||
4281|196|B|||
4281|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4281|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4281|199|O|poison control center right away. US residents can call||
4281|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4281|201|O|Symptoms of overdose may include severe dizziness, weakness,||
4281|202|O|fainting.||
4281|203|B|||
4281|204|N|NOTES:  Do not share this medication with others.||
4281|205|N|   Lifestyle changes that may help this medication work better||
4281|206|N|include exercising, stopping smoking, and eating a||
4281|207|N|low-cholesterol/low-fat diet. Consult your doctor for more||
4281|208|N|details.||
4281|209|N|   Lab and/or medical tests (such as sodium and potassium levels,||
4281|210|N|kidney function, skin exams, cholesterol levels) should be done||
4281|211|N|while you are taking this medication. Keep all medical and lab||
4281|212|N|appointments. Consult your doctor for more details.||
4281|213|N|   Check your blood pressure and pulse (heart rate) regularly||
4281|214|N|while taking this medication. Learn how to check your own blood||
4281|215|N|pressure and pulse at home, and share the results with your||
4281|216|N|doctor.||
4281|217|B|||
4281|218|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4281|219|D|remember. If it is near the time of the next dose, skip the||
4281|220|D|missed dose. Take your next dose at the regular time. Do not||
4281|221|D|double the dose to catch up.||
4281|222|B|||
4281|223|R|STORAGE:  Store at room temperature away from light and moisture.||
4281|224|R|Do not store in the bathroom. Keep all medications away from||
4281|225|R|children and pets.||
4281|226|R|   Do not flush medications down the toilet or pour them into a||
4281|227|R|drain unless instructed to do so. Properly discard this product||
4281|228|R|when it is expired or no longer needed. Consult your pharmacist||
4281|229|R|or local waste disposal company.||
4281|230|B|||
4281|231|A|Information last revised March 2025.||
4281|232|A|Copyright(c) 2025 First Databank, Inc.||
4281|233|B|||
4284|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4284|002|Z|does NOT have all possible information about this product. This||
4284|003|Z|information does not assure that this product is safe, effective,||
4284|004|Z|or appropriate for you. This information is not individual||
4284|005|Z|medical advice and does not substitute for the advice of your||
4284|006|Z|health care professional. Always ask your health care||
4284|007|Z|professional for complete information about this product and your||
4284|008|Z|specific health needs.||
4284|009|B|||
4284|010|T|ROSUVASTATIN - ORAL||
4284|011|F|(roe-SUE-vuh-stah-tin)||
4284|012|B|||
4284|013|C|COMMON BRAND NAME(S): Crestor, Ezallor Sprinkle||
4284|014|B|||
4284|015|U|USES:  Rosuvastatin is used along with a proper diet to help||
4284|016|U|lower "bad" cholesterol and fats (such as LDL, triglycerides) and||
4284|017|U|raise "good" cholesterol (HDL) in the blood. It belongs to a||
4284|018|U|group of drugs known as "statins." It works by reducing the||
4284|019|U|amount of cholesterol made by the liver. Lowering "bad"||
4284|020|U|cholesterol and triglycerides and raising "good" cholesterol||
4284|021|U|decreases the risk of heart disease and helps to prevent strokes||
4284|022|U|and heart attacks.||
4284|023|U|   In addition to eating a proper diet (such as a low||
4284|024|U|cholesterol/low-fat diet), other lifestyle changes that may help||
4284|025|U|this medication work better include exercising, losing weight if||
4284|026|U|overweight, and stopping smoking. Talk with your doctor for more||
4284|027|U|details.||
4284|028|B|||
4284|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4284|030|H|from your pharmacist before you start taking rosuvastatin and||
4284|031|H|each time you get a refill. If you have any questions, ask your||
4284|032|H|doctor or pharmacist.||
4284|033|H|   Take this medication by mouth with or without food as directed||
4284|034|H|by your doctor, usually once daily.||
4284|035|H|   If you are taking the capsule form of this medication, swallow||
4284|036|H|the capsules whole. Do not crush or chew the capsules. If you||
4284|037|H|have trouble swallowing the capsules, read and follow the||
4284|038|H|manufacturer's Instructions for Use leaflet. You may carefully||
4284|039|H|open the capsule and sprinkle the contents on 1 teaspoonful of||
4284|040|H|soft food (such as applesauce, or chocolate- or vanilla-flavored||
4284|041|H|pudding). Swallow all of the mixture without chewing. Use/discard||
4284|042|H|the mixture within 60 minutes. Do not prepare a supply in||
4284|043|H|advance.||
4284|044|H|   The dosage is based on your medical condition, response to||
4284|045|H|treatment, age, race, and other medications you may be taking. Be||
4284|046|H|sure to tell your doctor and pharmacist about all the products||
4284|047|H|you use (including prescription drugs, nonprescription drugs, and||
4284|048|H|herbal products). If you are of Asian descent, your doctor may||
4284|049|H|direct you to start with a lower dose because you may be more||
4284|050|H|sensitive to its effects.||
4284|051|H|   Antacids containing aluminum or magnesium can reduce the||
4284|052|H|absorption of this drug. If taking this type of antacid, take it||
4284|053|H|at least 2 hours after this medication.||
4284|054|H|   Take this medication regularly in order to get the most||
4284|055|H|benefit from it. Remember to take it at the same time each day.||
4284|056|H|Keep taking this medication even if you feel well. Most people||
4284|057|H|with high cholesterol or triglycerides do not feel sick.||
4284|058|H|   It is very important to continue to follow your doctor's||
4284|059|H|advice about diet and exercise. It may take up to 4 weeks before||
4284|060|H|you get the full benefit of this drug.||
4284|061|B|||
4284|062|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
4284|063|S|because your doctor has judged that the benefit to you is greater||
4284|064|S|than the risk of side effects. Many people using this medication||
4284|065|S|do not have serious side effects.||
4284|066|S|   A very small number of people taking rosuvastatin may have||
4284|067|S|mild memory problems or confusion. If these rare effects occur,||
4284|068|S|talk to your doctor.||
4284|069|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
4284|070|S|doctor about the benefits and risks.||
4284|071|S|   Tell your doctor right away if you have any serious side||
4284|072|S|effects, including: foamy urine.||
4284|073|S|   This drug may rarely cause muscle problems (which can rarely||
4284|074|S|lead to very serious conditions called rhabdomyolysis and||
4284|075|S|autoimmune myopathy). Tell your doctor right away if you develop||
4284|076|S|any of these symptoms during treatment and if these symptoms last||
4284|077|S|after your doctor stops this drug: muscle||
4284|078|S|pain/tenderness/weakness (especially with fever or unusual||
4284|079|S|tiredness), signs of kidney problems (such as change in the||
4284|080|S|amount of urine).||
4284|081|S|   This medication may rarely cause liver problems. Tell your||
4284|082|S|doctor right away if you develop symptoms of liver problems,||
4284|083|S|including: nausea/vomiting that doesn't stop, yellowing||
4284|084|S|eyes/skin, dark urine, stomach/abdominal pain.||
4284|085|S|   A very serious allergic reaction to this drug is rare.||
4284|086|S|However, get medical help right away if you notice any symptoms||
4284|087|S|of a serious allergic reaction, including: rash, itching/swelling||
4284|088|S|(especially of the face/tongue/throat), dizziness, trouble||
4284|089|S|breathing.||
4284|090|S|   This is not a complete list of possible side effects. If you||
4284|091|S|notice other effects not listed above, contact your doctor or||
4284|092|S|pharmacist.||
4284|093|S|   In the US -||
4284|094|S|   Call your doctor for medical advice about side effects. You||
4284|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4284|096|S|www.fda.gov/medwatch.||
4284|097|S|   In Canada - Call your doctor for medical advice about side||
4284|098|S|effects. You may report side effects to Health Canada at||
4284|099|S|1-866-234-2345.||
4284|100|B|||
4284|101|P|PRECAUTIONS:  Before taking rosuvastatin, tell your doctor or||
4284|102|P|pharmacist if you are allergic to it; or if you have any other||
4284|103|P|allergies. This product may contain inactive ingredients, which||
4284|104|P|can cause allergic reactions or other problems. Talk to your||
4284|105|P|pharmacist for more details.||
4284|106|P|   Before using this medication, tell your doctor or pharmacist||
4284|107|P|your medical history, especially of: liver disease, kidney||
4284|108|P|disease, alcohol use.||
4284|109|P|   Before having surgery, tell your doctor or dentist about all||
4284|110|P|the products you use (including prescription drugs,||
4284|111|P|nonprescription drugs, and herbal products).||
4284|112|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
4284|113|P|your risk for liver problems, especially when combined with||
4284|114|P|rosuvastatin. Ask your doctor or pharmacist for more information.||
4284|115|P|   Older adults may be more sensitive to the side effects of this||
4284|116|P|drug, especially muscle problems.||
4284|117|P|   During pregnancy, this medication should be used only when||
4284|118|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
4284|119|P|benefits with your doctor.||
4284|120|P|   This medication passes into breast milk. Because of the||
4284|121|P|possible risk to the infant, breastfeeding is not recommended||
4284|122|P|while using this medication. Consult your doctor before||
4284|123|P|breastfeeding.||
4284|124|B|||
4284|125|I|DRUG INTERACTIONS:  See also How to Use section.||
4284|126|I|   Drug interactions may change how your medications work or||
4284|127|I|increase your risk for serious side effects. This document does||
4284|128|I|not contain all possible drug interactions. Keep a list of all||
4284|129|I|the products you use (including prescription/nonprescription||
4284|130|I|drugs and herbal products) and share it with your doctor and||
4284|131|I|pharmacist. Do not start, stop, or change the dosage of any||
4284|132|I|medicines without your doctor's approval.||
4284|133|I|   Some products that may interact with this drug include:||
4284|134|I|daptomycin, gemfibrozil.||
4284|135|I|   Other medications can affect the removal of rosuvastatin from||
4284|136|I|your body, which may affect how rosuvastatin works. Examples||
4284|137|I|include ledipasvir, sofosbuvir/velpatasvir/voxilaprevir, among||
4284|138|I|others.||
4284|139|I|   Do not take any red yeast rice products while you are taking||
4284|140|I|rosuvastatin because some red yeast rice products may also||
4284|141|I|contain a statin called lovastatin. Taking rosuvastatin and red||
4284|142|I|yeast rice products together can increase your risk of serious||
4284|143|I|muscle and liver problems.||
4284|144|B|||
4284|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4284|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4284|147|O|poison control center right away. US residents can call||
4284|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4284|149|B|||
4284|150|N|NOTES:  Do not share this medication with others.||
4284|151|N|   Lab and/or medical tests (such as blood||
4284|152|N|cholesterol/triglyceride levels, liver function) should be done||
4284|153|N|while you are taking this medication. Keep all medical and lab||
4284|154|N|appointments. Consult your doctor for more details.||
4284|155|B|||
4284|156|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4284|157|D|remember. If it is within 12 hours of the next dose, skip the||
4284|158|D|missed dose. Take your next dose at the regular time. Do not||
4284|159|D|double the dose to catch up.||
4284|160|B|||
4284|161|R|STORAGE:  Store at room temperature away from light and moisture.||
4284|162|R|Do not store in the bathroom. Keep all medications away from||
4284|163|R|children and pets.||
4284|164|R|   Do not flush medications down the toilet or pour them into a||
4284|165|R|drain unless instructed to do so. Properly discard this product||
4284|166|R|when it is expired or no longer needed. Consult your pharmacist||
4284|167|R|or local waste disposal company.||
4284|168|B|||
4284|169|A|Information last revised May 2024.||
4284|170|A|Copyright(c) 2025 First Databank, Inc.||
4284|171|B|||
4289|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4289|002|Z|does NOT have all possible information about this product. This||
4289|003|Z|information does not assure that this product is safe, effective,||
4289|004|Z|or appropriate for you. This information is not individual||
4289|005|Z|medical advice and does not substitute for the advice of your||
4289|006|Z|health care professional. Always ask your health care||
4289|007|Z|professional for complete information about this product and your||
4289|008|Z|specific health needs.||
4289|009|B|||
4289|010|T|DICLOFENAC 3% - TOPICAL||
4289|011|F|(dye-KLOE-fen-ak)||
4289|012|B|||
4289|013|C|COMMON BRAND NAME(S): Solaraze||
4289|014|B|||
4289|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
4289|016|W|diclofenac) may rarely increase the risk for a heart attack or||
4289|017|W|stroke. This effect can happen at any time while using this drug||
4289|018|W|but is more likely if you use it for a long time. The risk may be||
4289|019|W|greater in older adults or if you have heart disease or increased||
4289|020|W|risk for heart disease (for example, due to smoking, family||
4289|021|W|history of heart disease, or conditions such as high blood||
4289|022|W|pressure or diabetes). Do not use this drug right before or after||
4289|023|W|heart bypass surgery (CABG).||
4289|024|W|   Stop using diclofenac and get medical help right away if you||
4289|025|W|notice any of these rare but serious side effects: chest/jaw/left||
4289|026|W|arm pain, shortness of breath, unusual sweating, confusion,||
4289|027|W|weakness on one side of the body, trouble speaking, sudden vision||
4289|028|W|changes.||
4289|029|W|   Talk to your doctor or pharmacist about the benefits and risks||
4289|030|W|of using this drug.||
4289|031|B|||
4289|032|U|USES:  See also Warning section.||
4289|033|U|   This medication is used to treat a certain skin condition||
4289|034|U|(actinic keratoses). Diclofenac is known as a nonsteroidal||
4289|035|U|anti-inflammatory drug (NSAID).||
4289|036|B|||
4289|037|H|HOW TO USE:  Read the Medication Guide provided by your||
4289|038|H|pharmacist before you start using diclofenac and each time you||
4289|039|H|get a refill. If you have any questions, ask your doctor or||
4289|040|H|pharmacist.||
4289|041|H|   This medication is for use on the skin only. Wash and dry your||
4289|042|H|hands before applying the medication. Gently apply enough||
4289|043|H|medication to cover the affected skin well as directed by your||
4289|044|H|doctor, usually 2 times daily. This medication is usually applied||
4289|045|H|for 60 to 90 days. Wash your hands after using, unless you are||
4289|046|H|using this medication to treat the hands.||
4289|047|H|   The dosage is based on your medical condition and response to||
4289|048|H|treatment. To reduce your risk of side effects, use this||
4289|049|H|medication at the lowest effective dose for the shortest possible||
4289|050|H|time. Do not increase your dose or use this drug more often or||
4289|051|H|for longer than prescribed. Discuss the risks and benefits with||
4289|052|H|your doctor or pharmacist.||
4289|053|H|   Do not apply the medication in or around the eyes, open skin||
4289|054|H|wounds, or infected/scraped/burned skin. If you do get the||
4289|055|H|medication in those areas, flush with plenty of water.||
4289|056|H|   Use this medication regularly to get the most benefit from it.||
4289|057|H|To help you remember, use it at the same times each day.||
4289|058|H|   Tell your doctor if your condition lasts or gets worse. It may||
4289|059|H|take up to 30 days after finishing the medication for the skin to||
4289|060|H|completely heal.||
4289|061|B|||
4289|062|S|SIDE EFFECTS:  See also Warning section.||
4289|063|S|   Rash, scaling, dry skin, swelling, or itching may occur at the||
4289|064|S|application site. If any of these effects last or get worse, tell||
4289|065|S|your doctor or pharmacist promptly.||
4289|066|S|   Remember that this medication has been prescribed because your||
4289|067|S|doctor has judged that the benefit to you is greater than the||
4289|068|S|risk of side effects. Many people using this medication do not||
4289|069|S|have serious side effects.||
4289|070|S|   This medication may raise your blood pressure. Check your||
4289|071|S|blood pressure regularly and tell your doctor if the results are||
4289|072|S|high.||
4289|073|S|   Tell your doctor right away if you have any serious side||
4289|074|S|effects, including: signs of kidney problems (such as change in||
4289|075|S|the amount of urine), symptoms of heart failure (such as swelling||
4289|076|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
4289|077|S|   Other medications similar to this medication may rarely cause||
4289|078|S|serious bleeding from the stomach or intestines. If you notice||
4289|079|S|any of the following rare but very serious side effects, stop||
4289|080|S|using this medication and get medical help right away:||
4289|081|S|stomach/abdominal pain that doesn't go away, black/bloody stools,||
4289|082|S|vomit that looks like coffee grounds.||
4289|083|S|   This drug may rarely cause serious (possibly fatal) liver||
4289|084|S|disease. Get medical help right away if you have any symptoms of||
4289|085|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
4289|086|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
4289|087|S|urine.||
4289|088|S|   A very serious allergic reaction to this drug is rare.||
4289|089|S|However, get medical help right away if you notice any symptoms||
4289|090|S|of a serious allergic reaction, including: fever, swollen lymph||
4289|091|S|nodes, rash, itching/swelling (especially of the||
4289|092|S|face/tongue/throat), severe dizziness, trouble breathing.||
4289|093|S|   This is not a complete list of possible side effects. If you||
4289|094|S|notice other effects not listed above, contact your doctor or||
4289|095|S|pharmacist.||
4289|096|S|   In the US -||
4289|097|S|   Call your doctor for medical advice about side effects. You||
4289|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4289|099|S|www.fda.gov/medwatch.||
4289|100|S|   In Canada - Call your doctor for medical advice about side||
4289|101|S|effects. You may report side effects to Health Canada at||
4289|102|S|1-866-234-2345.||
4289|103|B|||
4289|104|P|PRECAUTIONS:  See also Warning section.||
4289|105|P|   Before using diclofenac, tell your doctor or pharmacist if you||
4289|106|P|are allergic to it; or to aspirin or other NSAIDs (such as||
4289|107|P|ibuprofen, naproxen, celecoxib); or if you have any other||
4289|108|P|allergies. This product may contain inactive ingredients (such as||
4289|109|P|benzyl alcohol), which can cause allergic reactions or other||
4289|110|P|problems. Talk to your pharmacist for more details.||
4289|111|P|   Before using this medication, tell your doctor or pharmacist||
4289|112|P|your medical history, especially of: asthma (including a history||
4289|113|P|of worsening breathing after taking aspirin or other NSAIDs),||
4289|114|P|liver disease, stomach/intestine problems (such as bleeding,||
4289|115|P|ulcers), heart disease (such as previous heart attack), high||
4289|116|P|blood pressure, stroke, swelling (edema, fluid retention),||
4289|117|P|diabetes, blood disorders (such as anemia), bleeding/clotting||
4289|118|P|problems, growths in the nose (nasal polyps).||
4289|119|P|   Kidney problems can sometimes occur with the use of NSAID||
4289|120|P|medications, including diclofenac. Problems are more likely to||
4289|121|P|occur if you are dehydrated, have heart failure or kidney||
4289|122|P|disease, are an older adult, or if you take certain medications||
4289|123|P|(see also Drug Interactions section). Drink plenty of fluids as||
4289|124|P|directed by your doctor to prevent dehydration and tell your||
4289|125|P|doctor right away if you have a change in the amount of urine.||
4289|126|P|   Before having surgery, tell your doctor or dentist about all||
4289|127|P|the products you use (including prescription drugs,||
4289|128|P|nonprescription drugs, and herbal products).||
4289|129|P|   This medicine may rarely cause stomach bleeding. Daily use of||
4289|130|P|alcohol and tobacco while using this medicine may increase your||
4289|131|P|risk for stomach bleeding. Limit alcohol and stop smoking. Ask||
4289|132|P|your doctor or pharmacist about how much alcohol you may safely||
4289|133|P|drink.||
4289|134|P|   Your condition may get worse when exposed to the sun. Limit||
4289|135|P|your time in the sun. Avoid tanning booths and sunlamps. Wear||
4289|136|P|protective clothing when outdoors. Ask your doctor if you should||
4289|137|P|use sunscreen along with this medication.||
4289|138|P|   Older adults may be at greater risk for stomach/intestinal||
4289|139|P|bleeding, kidney problems, heart attack, and stroke while using||
4289|140|P|this drug.||
4289|141|P|   Before using this medication, women of childbearing age should||
4289|142|P|talk with their doctor(s) about the benefits and risks. Tell your||
4289|143|P|doctor if you are pregnant or if you plan to become pregnant.||
4289|144|P|This medication may harm an unborn baby and cause problems with||
4289|145|P|normal labor/delivery. It is not recommended for use in pregnancy||
4289|146|P|from 20 weeks until delivery. If your doctor decides that you||
4289|147|P|need to use this medication between 20 and 30 weeks of pregnancy,||
4289|148|P|you should use the lowest effective dose for the shortest||
4289|149|P|possible time. You should not use this medication after 30 weeks||
4289|150|P|of pregnancy.||
4289|151|P|   It is unknown if this form of diclofenac passes into breast||
4289|152|P|milk. Consult your doctor before breastfeeding.||
4289|153|B|||
4289|154|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4289|155|I|medications work or increase your risk for serious side effects.||
4289|156|I|This document does not contain all possible drug interactions.||
4289|157|I|Keep a list of all the products you use (including||
4289|158|I|prescription/nonprescription drugs and herbal products) and share||
4289|159|I|it with your doctor and pharmacist. Do not start, stop, or change||
4289|160|I|the dosage of any medicines without your doctor's approval.||
4289|161|I|   Some products that may interact with this drug include:||
4289|162|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
4289|163|I|angiotensin II receptor blockers (such as valsartan, losartan),||
4289|164|I|cidofovir, corticosteroids (such as dexamethasone, prednisone),||
4289|165|I|lithium, methotrexate, "water pills" (diuretics such as||
4289|166|I|furosemide).||
4289|167|I|   This medication may increase the risk of bleeding when used||
4289|168|I|with other drugs that also may cause bleeding. Examples include||
4289|169|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
4289|170|I|dabigatran/enoxaparin/warfarin, among others.||
4289|171|I|   Check all prescription and nonprescription medicine labels||
4289|172|I|carefully since many medications contain pain relievers/fever||
4289|173|I|reducers (aspirin, NSAIDs such as ibuprofen, naproxen, or||
4289|174|I|ketorolac). These drugs are similar to diclofenac and may||
4289|175|I|increase your risk of side effects if taken together. However, if||
4289|176|I|your doctor has told you to take low-dose aspirin to prevent||
4289|177|I|heart attack or stroke (usually 81-162 milligrams a day), you||
4289|178|I|should keep taking the aspirin unless your doctor tells you not||
4289|179|I|to. Ask your doctor or pharmacist for more details.||
4289|180|B|||
4289|181|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
4289|182|O|has overdosed and has serious symptoms such as passing out or||
4289|183|O|trouble breathing, call 911. Otherwise, call a poison control||
4289|184|O|center right away. US residents can call 1-800-222-1222. Canada||
4289|185|O|residents can call 1-844-764-7669. Symptoms of overdose may||
4289|186|O|include: severe stomach pain, change in the amount of urine,||
4289|187|O|slow/shallow breathing.||
4289|188|B|||
4289|189|N|NOTES:  Do not share this medication with others.||
4289|190|N|   Lab and/or medical tests (such as blood pressure, complete||
4289|191|N|blood count, liver/kidney function) should be done while you are||
4289|192|N|using this medication. Keep all medical and lab appointments.||
4289|193|N|Consult your doctor for more details.||
4289|194|B|||
4289|195|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4289|196|D|If it is near the time of the next dose, skip the missed dose.||
4289|197|D|Use your next dose at the regular time. Do not double the dose to||
4289|198|D|catch up.||
4289|199|B|||
4289|200|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
4289|201|R|medications away from children and pets.||
4289|202|R|   Do not flush medications down the toilet or pour them into a||
4289|203|R|drain unless instructed to do so. Properly discard this product||
4289|204|R|when it is expired or no longer needed. Consult your pharmacist||
4289|205|R|or local waste disposal company.||
4289|206|B|||
4289|207|A|Information last revised November 2025.||
4289|208|A|Copyright(c) 2025 First Databank, Inc.||
4289|209|B|||
4300|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4300|002|Z|does NOT have all possible information about this product. This||
4300|003|Z|information does not assure that this product is safe, effective,||
4300|004|Z|or appropriate for you. This information is not individual||
4300|005|Z|medical advice and does not substitute for the advice of your||
4300|006|Z|health care professional. Always ask your health care||
4300|007|Z|professional for complete information about this product and your||
4300|008|Z|specific health needs.||
4300|009|B|||
4300|010|T|LEVONORGESTREL-RELEASING 5 YEAR SYSTEM - INTRAUTERINE||
4300|011|F|(LEE-voe-nor-JES-trel)||
4300|012|B|||
4300|013|C|COMMON BRAND NAME(S): Kyleena||
4300|014|B|||
4300|015|U|USES:  This product is a small, flexible device that is placed in||
4300|016|U|the womb (uterus) to prevent pregnancy. It is used by women who||
4300|017|U|want to use a reversible birth control method that works for a||
4300|018|U|long time (up to 5 years). It is also used to treat heavy||
4300|019|U|menstrual bleeding in women who choose to use this birth control||
4300|020|U|method. The device slowly releases a hormone (levonorgestrel)||
4300|021|U|that is similar to a hormone that women normally make. This||
4300|022|U|device and hormone helps prevent pregnancy.||
4300|023|U|   This product does not protect against sexually transmitted||
4300|024|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
4300|025|U|an effective barrier method (latex or polyurethane condom/dental||
4300|026|U|dams) during sexual activity will help to decrease your risk of||
4300|027|U|infection.||
4300|028|B|||
4300|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4300|030|H|from your pharmacist before you start using this product. If you||
4300|031|H|have any questions, ask your doctor or pharmacist.||
4300|032|H|   This device is placed in your uterus by a health care provider||
4300|033|H|during an in-office visit. It is left in place for up to 5 years.||
4300|034|H|Schedule a follow-up visit 4 to 6 weeks after the device is||
4300|035|H|placed to make sure it is still in the proper position.||
4300|036|H|   Ask your doctor if you need to use a backup form of birth||
4300|037|H|control for the first 7 days after this device is placed to||
4300|038|H|prevent pregnancy until the device has enough time to work.||
4300|039|H|   This device may sometimes move out of place or come out by||
4300|040|H|itself. After each menstrual period, check to make sure it is in||
4300|041|H|the proper position. Learn how to carefully check the position of||
4300|042|H|this device from the Patient Information Leaflet and/or your||
4300|043|H|health care provider. If it comes out or if you cannot feel the||
4300|044|H|threads, contact your doctor promptly and use a backup form of||
4300|045|H|non-hormonal birth control (such as condoms, spermicide) to||
4300|046|H|prevent pregnancy until otherwise directed by your doctor.||
4300|047|H|   If you wish to continue this method of birth control after 5||
4300|048|H|years, the used device may be removed and replaced with a new||
4300|049|H|one. Either way, the used device should be removed after 5 years.||
4300|050|H|Your health care provider can remove this device whenever you||
4300|051|H|want to stop using this method of birth control.||
4300|052|B|||
4300|053|S|SIDE EFFECTS:  Pain, bleeding, or dizziness during and after||
4300|054|S|placement of the device may occur. Cramps, irregular menstrual||
4300|055|S|periods, and vaginal bleeding between periods (spotting) may||
4300|056|S|occur, especially during the first few weeks of use. Headache,||
4300|057|S|nausea, breast tenderness, or weight gain may also occur. If any||
4300|058|S|of these effects last or get worse, tell your doctor promptly.||
4300|059|S|   After your body adjusts to this product, it is normal to have||
4300|060|S|fewer bleeding days during your menstrual periods, and some women||
4300|061|S|stop having periods altogether. This will not affect your ability||
4300|062|S|to become pregnant after stopping use of this product.||
4300|063|S|   Remember that this medication device has been prescribed||
4300|064|S|because your doctor has judged that the benefit to you is greater||
4300|065|S|than the risk of side effects. Many people using this device do||
4300|066|S|not have serious side effects.||
4300|067|S|   Tell your doctor right away if you have any serious side||
4300|068|S|effects, including: stomach/abdominal pain, vomiting, lumps in||
4300|069|S|the breast, mental/mood changes (such as new/worsening||
4300|070|S|depression), unusual changes in vaginal bleeding (such as||
4300|071|S|continuous spotting, sudden heavy bleeding, missed periods), dark||
4300|072|S|urine, yellowing eyes/skin, unusual headaches (including||
4300|073|S|headaches with vision changes/lack of coordination, worsening of||
4300|074|S|migraines, sudden/very severe headaches).||
4300|075|S|   Using an intrauterine device (IUD) may increase your risk for||
4300|076|S|a rare but serious pelvic infection (pelvic inflammatory||
4300|077|S|disease-PID), which can cause permanent damage to sex organs and||
4300|078|S|infertility. The risk is greater in women who have multiple||
4300|079|S|sexual partners, or infection with a sexually transmitted disease||
4300|080|S|(STD), or who have had PID in the past (see also Precautions||
4300|081|S|section). Tell your doctor right away if you experience symptoms||
4300|082|S|of PID, including: unexplained fever/chills, lower||
4300|083|S|abdominal/pelvic pain, pain during sexual intercourse, genital||
4300|084|S|sores, unusual vaginal discharge.||
4300|085|S|   A very serious allergic reaction to this drug is rare.||
4300|086|S|However, get medical help right away if you notice any symptoms||
4300|087|S|of a serious allergic reaction, including: rash, itching/swelling||
4300|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4300|089|S|breathing.||
4300|090|S|   This is not a complete list of possible side effects. If you||
4300|091|S|notice other effects not listed above, contact your doctor or||
4300|092|S|pharmacist.||
4300|093|S|   In the US -||
4300|094|S|   Call your doctor for medical advice about side effects. You||
4300|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4300|096|S|www.fda.gov/medwatch.||
4300|097|S|   In Canada - Call your doctor for medical advice about side||
4300|098|S|effects. You may report side effects to Health Canada at||
4300|099|S|1-866-234-2345.||
4300|100|B|||
4300|101|P|PRECAUTIONS:  Before using this medication device, tell your||
4300|102|P|doctor or pharmacist if you are allergic to levonorgestrel, or to||
4300|103|P|any other progestins (such as norethindrone, desogestrel); or if||
4300|104|P|you have any other allergies. This product may contain inactive||
4300|105|P|ingredients, which can cause allergic reactions or other||
4300|106|P|problems. Talk to your pharmacist for more details.||
4300|107|P|   Before using this product, tell your doctor or pharmacist your||
4300|108|P|medical history, especially of: recent pregnancy, current||
4300|109|P|breastfeeding, bleeding/blood disorders, high blood pressure,||
4300|110|P|abnormal breast exam, cancer (especially endometrial or breast||
4300|111|P|cancer), depression, diabetes, severe headaches/migraines, heart||
4300|112|P|problems (such as heart valve disease, irregular heartbeat,||
4300|113|P|previous heart attack), liver disease (including tumors),||
4300|114|P|previous pregnancy outside the uterus (ectopic pregnancy),||
4300|115|P|stroke, unexplained vaginal bleeding, uterus problems (such as||
4300|116|P|fibroids, pelvic inflammatory disease-PID), conditions that||
4300|117|P|weaken the immune system/increase the risk of infection (such as||
4300|118|P|HIV, leukemia, IV drug abuse).||
4300|119|P|   If you or partner have other sexual partners, this device may||
4300|120|P|not be the best birth control method for you. If you or your||
4300|121|P|partner get a sexually transmitted disease (including HIV,||
4300|122|P|gonorrhea, chlamydia), contact your doctor right away. Ask your||
4300|123|P|doctor if you should continue to use this device for birth||
4300|124|P|control.||
4300|125|P|   Before having surgery, tell your doctor or dentist about all||
4300|126|P|the products you use (including prescription drugs,||
4300|127|P|nonprescription drugs, and herbal products). Also, if you are||
4300|128|P|going to have an MRI test, tell testing personnel that you are||
4300|129|P|using this device. They may need to adjust your MRI test.||
4300|130|P|   This device should not be used during pregnancy. If you become||
4300|131|P|pregnant or think you may be pregnant, tell your doctor right||
4300|132|P|away.||
4300|133|P|   Levonorgestrel passes into breast milk. Consult your doctor||
4300|134|P|before breastfeeding.||
4300|135|B|||
4300|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4300|137|I|medications work or increase your risk for serious side effects.||
4300|138|I|This document does not contain all possible drug interactions.||
4300|139|I|Keep a list of all the products you use (including||
4300|140|I|prescription/nonprescription drugs and herbal products) and share||
4300|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
4300|142|I|the dosage of any medicines without your doctor's approval.||
4300|143|B|||
4300|144|O|OVERDOSE:  This medication device may be harmful if swallowed. If||
4300|145|O|someone has swallowed it and has serious symptoms such as passing||
4300|146|O|out or trouble breathing, call 911. Otherwise, call a poison||
4300|147|O|control center right away. US residents can call 1-800-222-1222.||
4300|148|O|Canada residents can call 1-844-764-7669.||
4300|149|B|||
4300|150|N|NOTES:  You should have regular complete physical exams including||
4300|151|N|blood pressure, breast exam, pelvic exam, and screening for||
4300|152|N|cervical cancer (Pap smear). Follow your doctor's instructions||
4300|153|N|for examining your breasts, and report any lumps right away. Keep||
4300|154|N|all medical and lab appointments. Consult your doctor for more||
4300|155|N|details.||
4300|156|B|||
4300|157|D|MISSED DOSE:  Not applicable.||
4300|158|B|||
4300|159|R|STORAGE:  Before use, store at room temperature. Keep all||
4300|160|R|medications and medical devices away from children and pets.||
4300|161|R|   Do not flush medications down the toilet or pour them into a||
4300|162|R|drain unless instructed to do so. Properly discard this product||
4300|163|R|when it is expired or no longer needed. Consult your pharmacist||
4300|164|R|or local waste disposal company.||
4300|165|B|||
4300|166|A|Information last revised October 2025.||
4300|167|A|Copyright(c) 2025 First Databank, Inc.||
4300|168|B|||
4301|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4301|002|Z|does NOT have all possible information about this product. This||
4301|003|Z|information does not assure that this product is safe, effective,||
4301|004|Z|or appropriate for you. This information is not individual||
4301|005|Z|medical advice and does not substitute for the advice of your||
4301|006|Z|health care professional. Always ask your health care||
4301|007|Z|professional for complete information about this product and your||
4301|008|Z|specific health needs.||
4301|009|B|||
4301|010|T|PIMECROLIMUS - TOPICAL||
4301|011|F|(pim-eck-row-LEE-muss)||
4301|012|B|||
4301|013|C|COMMON BRAND NAME(S): Elidel||
4301|014|B|||
4301|015|W|WARNING:  The long-term safety of this drug is not known. There||
4301|016|W|have been rare reports of cancer (such as skin cancer, lymphoma)||
4301|017|W|in patients using pimecrolimus on the skin. It is unknown if||
4301|018|W|pimecrolimus caused these cancers. Because of this possible risk,||
4301|019|W|this drug should be used only if other drugs have not worked or||
4301|020|W|if your doctor decides that other medications should not be used||
4301|021|W|for your condition. Pimecrolimus should be used on the skin for||
4301|022|W|short treatment periods only. If needed, treatment may be||
4301|023|W|repeated with breaks in between. Use the smallest amount that||
4301|024|W|will treat your condition properly, and apply only on the||
4301|025|W|affected skin. This medication should not be used by children||
4301|026|W|younger than 2 years. Discuss the risks, benefits, and proper use||
4301|027|W|of this medication with your doctor. Tell your doctor right away||
4301|028|W|if you develop any of the following: unusual skin changes, change||
4301|029|W|in the appearance/size of moles, unusual growths/lumps, or||
4301|030|W|swollen lymph nodes.||
4301|031|B|||
4301|032|U|USES:  Pimecrolimus is used to treat certain skin conditions such||
4301|033|U|as eczema (atopic dermatitis) in people who should not use or||
4301|034|U|have not responded to other eczema medications (such as topical||
4301|035|U|steroids). Eczema is an allergic-type condition that causes red,||
4301|036|U|irritated, and itchy skin. This drug works by changing the skin's||
4301|037|U|defense (immune) system, thereby decreasing the allergic reaction||
4301|038|U|that causes eczema. Pimecrolimus belongs to a class of drugs||
4301|039|U|known as topical calcineurin inhibitors (TCIs).||
4301|040|B|||
4301|041|V|OTHER USES:  This section contains uses of this drug that are not||
4301|042|V|listed in the approved professional labeling for the drug but||
4301|043|V|that may be prescribed by your health care professional. Use this||
4301|044|V|drug for a condition that is listed in this section only if it||
4301|045|V|has been so prescribed by your health care professional.||
4301|046|V|   This medication may also be used for a certain skin condition||
4301|047|V|that causes patchy loss of skin coloring (vitiligo).||
4301|048|B|||
4301|049|H|HOW TO USE:  Read the Medication Guide provided by your||
4301|050|H|pharmacist before you start using pimecrolimus and each time you||
4301|051|H|get a refill. If you have any questions, ask your doctor or||
4301|052|H|pharmacist.||
4301|053|H|   Wash your hands with soap and water before using this||
4301|054|H|medication. Apply a thin layer to the affected areas of skin as||
4301|055|H|directed by your doctor, usually twice daily. Rub the medication||
4301|056|H|into the skin gently and completely. Wash your hands after using||
4301|057|H|this product unless your hands are being treated. If your doctor||
4301|058|H|recommends a moisturizer, apply it after this medication.||
4301|059|H|   Pimecrolimus is for use on the skin only. Avoid getting this||
4301|060|H|medication in your eyes or on the inside of your nose or mouth.||
4301|061|H|Do not apply this medication to open wounds or infected areas. Do||
4301|062|H|not cover the treated area with plastic or waterproof bandages||
4301|063|H|unless directed to do so by your doctor. Do not bathe, shower or||
4301|064|H|swim right after applying this medication.||
4301|065|H|   Use this medication exactly as directed. Your doctor may||
4301|066|H|instruct you to stop using it once your eczema has cleared up and||
4301|067|H|to start using it again if signs or symptoms reappear. Consult||
4301|068|H|your doctor for details.||
4301|069|H|   Tell your doctor if your condition does not get better after 6||
4301|070|H|weeks of using this medication or if your condition gets worse at||
4301|071|H|any time.||
4301|072|B|||
4301|073|S|SIDE EFFECTS:  Mild burning or irritation at the application site||
4301|074|S|may occur during the first few days of treatment. Headache may||
4301|075|S|also occur. If any of these effects last or get worse, tell your||
4301|076|S|doctor or pharmacist promptly.||
4301|077|S|   Remember that this medication has been prescribed because your||
4301|078|S|doctor has judged that the benefit to you is greater than the||
4301|079|S|risk of side effects. Many people using this medication do not||
4301|080|S|have serious side effects.||
4301|081|S|   Tell your doctor right away if you have any serious side||
4301|082|S|effects, including: signs of infection (such as sore throat that||
4301|083|S|doesn't go away, fever, chills).||
4301|084|S|   A very serious allergic reaction to this drug is rare.||
4301|085|S|However, get medical help right away if you notice any symptoms||
4301|086|S|of a serious allergic reaction, including: rash, itching/swelling||
4301|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4301|088|S|breathing.||
4301|089|S|   This is not a complete list of possible side effects. If you||
4301|090|S|notice other effects not listed above, contact your doctor or||
4301|091|S|pharmacist.||
4301|092|S|   In the US -||
4301|093|S|   Call your doctor for medical advice about side effects. You||
4301|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4301|095|S|www.fda.gov/medwatch.||
4301|096|S|   In Canada - Call your doctor for medical advice about side||
4301|097|S|effects. You may report side effects to Health Canada at||
4301|098|S|1-866-234-2345.||
4301|099|B|||
4301|100|P|PRECAUTIONS:  Before using pimecrolimus, tell your doctor or||
4301|101|P|pharmacist if you are allergic to it; or if you have any other||
4301|102|P|allergies. This product may contain inactive ingredients, which||
4301|103|P|can cause allergic reactions or other problems. Talk to your||
4301|104|P|pharmacist for more details.||
4301|105|P|   Before using this medication, tell your doctor or pharmacist||
4301|106|P|your medical history, especially of: use of light therapy (such||
4301|107|P|as UVA or UVB), cancer (such as skin cancer), other skin||
4301|108|P|conditions (such as Netherton's syndrome, skin infections||
4301|109|P|including herpes, shingles), immune system problems (such as||
4301|110|P|HIV).||
4301|111|P|   This medication may make you more sensitive to the sun. Limit||
4301|112|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4301|113|P|sunscreen and wear protective clothing when outdoors. Tell your||
4301|114|P|doctor right away if you get sunburned or have skin||
4301|115|P|blisters/redness.||
4301|116|P|   Before having surgery, tell your doctor or dentist about all||
4301|117|P|the products you use (including prescription drugs,||
4301|118|P|nonprescription drugs, and herbal products).||
4301|119|P|   During pregnancy, this medication should be used only when||
4301|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
4301|121|P|   It is unknown if this medication passes into breast milk.||
4301|122|P|Consult your doctor before breastfeeding.||
4301|123|B|||
4301|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4301|125|I|medications work or increase your risk for serious side effects.||
4301|126|I|This document does not contain all possible drug interactions.||
4301|127|I|Keep a list of all the products you use (including||
4301|128|I|prescription/nonprescription drugs and herbal products) and share||
4301|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
4301|130|I|the dosage of any medicines without your doctor's approval.||
4301|131|B|||
4301|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4301|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4301|134|O|poison control center right away. US residents can call||
4301|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
4301|136|O|medication may be harmful if swallowed.||
4301|137|B|||
4301|138|N|NOTES:  Do not share this medication with others.||
4301|139|N|   This medication has been prescribed for your current condition||
4301|140|N|only. Do not use it later for another condition unless your||
4301|141|N|doctor tells you to.||
4301|142|B|||
4301|143|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4301|144|D|If it is near the time of the next dose, skip the missed dose.||
4301|145|D|Use your next dose at the regular time. Do not double the dose to||
4301|146|D|catch up.||
4301|147|B|||
4301|148|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
4301|149|R|medications away from children and pets.||
4301|150|R|   Do not flush medications down the toilet or pour them into a||
4301|151|R|drain unless instructed to do so. Properly discard this product||
4301|152|R|when it is expired or no longer needed. Consult your pharmacist||
4301|153|R|or local waste disposal company.||
4301|154|B|||
4301|155|A|Information last revised May 2025.||
4301|156|A|Copyright(c) 2025 First Databank, Inc.||
4301|157|B|||
4303|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4303|002|Z|does NOT have all possible information about this product. This||
4303|003|Z|information does not assure that this product is safe, effective,||
4303|004|Z|or appropriate for you. This information is not individual||
4303|005|Z|medical advice and does not substitute for the advice of your||
4303|006|Z|health care professional. Always ask your health care||
4303|007|Z|professional for complete information about this product and your||
4303|008|Z|specific health needs.||
4303|009|B|||
4303|010|T|PNEUMOCOCCAL POLYSACCHARIDE VACCINE - INJECTION||
4303|011|F|(NEU-mo-KOK-al paa-lee-SA-kr-ide)||
4303|012|B|||
4303|013|C|COMMON BRAND NAME(S): Pneumovax 23, Pnu-Imune 23||
4303|014|B|||
4303|015|U|USES:  This vaccine is used to help prevent pneumococcal disease,||
4303|016|U|an infection caused by a certain bacteria (Streptococcus||
4303|017|U|pneumoniae). This bacteria can cause ear infections or other more||
4303|018|U|serious infections (such as pneumonia, meningitis, blood||
4303|019|U|infection). Vaccination is the best way to protect against this||
4303|020|U|disease. This vaccine works by increasing the body's natural||
4303|021|U|defense (immunity) against the bacteria.||
4303|022|U|   Vaccines may not fully protect everyone who receives them.||
4303|023|B|||
4303|024|H|HOW TO USE:  Read all vaccine information available from your||
4303|025|H|health care professional before receiving the vaccine. If you||
4303|026|H|have any questions, ask your health care professional.||
4303|027|H|   This vaccine is given by injection into a muscle or under the||
4303|028|H|skin by a health care professional. It is given in the upper arm||
4303|029|H|or thigh.||
4303|030|B|||
4303|031|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
4303|032|S|muscle/joint aches, fever, nausea, or vomiting may occur. If any||
4303|033|S|of these effects last or get worse, tell your health care||
4303|034|S|professional promptly.||
4303|035|S|   Rarely, some people have symptoms such as fainting, dizziness,||
4303|036|S|vision changes, or ringing in the ears just after getting a||
4303|037|S|vaccine injection. Tell your health care professional right away||
4303|038|S|if you have any of these symptoms. Sitting or lying down may||
4303|039|S|help, since these symptoms usually don't last long.||
4303|040|S|   Remember that this vaccine has been prescribed because your||
4303|041|S|health care professional has judged that the benefit to you is||
4303|042|S|greater than the risk of side effects. Many people using this||
4303|043|S|vaccine do not have serious side effects.||
4303|044|S|   A very serious allergic reaction to this vaccine is rare.||
4303|045|S|However, get medical help right away if you notice any symptoms||
4303|046|S|of a serious allergic reaction, including: rash, itching/swelling||
4303|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4303|048|S|breathing.||
4303|049|S|   This is not a complete list of possible side effects. If you||
4303|050|S|notice any other effects not listed, contact your health care||
4303|051|S|professional.||
4303|052|S|   Contact the health care professional for medical advice about||
4303|053|S|side effects. The following numbers do not provide medical||
4303|054|S|advice, but in the US you may report side effects to the Vaccine||
4303|055|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
4303|056|S|Canada, you may call the Vaccine Safety Section at Public Health||
4303|057|S|Agency of Canada at 1-866-844-0018.||
4303|058|B|||
4303|059|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
4303|060|P|care professional if you are allergic to it; or if you have any||
4303|061|P|other allergies. This product may contain inactive ingredients||
4303|062|P|(such as the preservative phenol, latex or dry natural rubber in||
4303|063|P|the vial stopper), which can cause allergic reactions or other||
4303|064|P|problems. Talk to your health care professional for more details.||
4303|065|P|   Before receiving this vaccine, tell your health care||
4303|066|P|professional your medical history, especially of: current||
4303|067|P|fever/illness, immune system disorders (such as due to HIV||
4303|068|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
4303|069|P|radiation treatment), vaccination history (including previous||
4303|070|P|reactions to any vaccines).||
4303|071|P|   During pregnancy, this vaccine should be used only when||
4303|072|P|clearly needed. Discuss the risks and benefits with your health||
4303|073|P|care professional.||
4303|074|P|   It is unknown if this vaccine passes into breast milk. Consult||
4303|075|P|your health care professional before breastfeeding.||
4303|076|B|||
4303|077|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4303|078|I|medications work or increase your risk for serious side effects.||
4303|079|I|This document does not contain all possible drug interactions.||
4303|080|I|Keep a list of all the products you use (including||
4303|081|I|prescription/nonprescription drugs and herbal products) and share||
4303|082|I|it with your health care professional. Do not start, stop, or||
4303|083|I|change the dosage of any medicines without your doctor's||
4303|084|I|approval.||
4303|085|I|   Some products that may interact with this vaccine are: drugs||
4303|086|I|that weaken the immune system (including cyclosporine,||
4303|087|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
4303|088|I|prednisone).||
4303|089|B|||
4303|090|O|OVERDOSE:  Not applicable.||
4303|091|B|||
4303|092|N|NOTES:  Keep all medical and lab appointments.||
4303|093|N|   Keep vaccine records for yourself and your children and||
4303|094|N|provide them to the health care professionals to prevent||
4303|095|N|unnecessary re-vaccinations.||
4303|096|B|||
4303|097|D|MISSED DOSE:  Not applicable.||
4303|098|B|||
4303|099|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
4303|100|R|medications away from children and pets.||
4303|101|R|   Do not flush medications down the toilet or pour them into a||
4303|102|R|drain unless instructed to do so. Properly discard this product||
4303|103|R|when it is expired or no longer needed. Consult your pharmacist||
4303|104|R|or local waste disposal company.||
4303|105|B|||
4303|106|A|Information last revised February 2025.||
4303|107|A|Copyright(c) 2025 First Databank, Inc.||
4303|108|B|||
4304|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4304|002|Z|does NOT have all possible information about this product. This||
4304|003|Z|information does not assure that this product is safe, effective,||
4304|004|Z|or appropriate for you. This information is not individual||
4304|005|Z|medical advice and does not substitute for the advice of your||
4304|006|Z|health care professional. Always ask your health care||
4304|007|Z|professional for complete information about this product and your||
4304|008|Z|specific health needs.||
4304|009|B|||
4304|010|T|IPRATROPIUM/ALBUTEROL (SALBUTAMOL) SOLUTION - INHALATION||
4304|011|F|(IP-ra-TROE-pee-um/al-BUE-ter-ol/sal-BUE-ta-mol)||
4304|012|B|||
4304|013|C|COMMON BRAND NAME(S): DuoNeb||
4304|014|B|||
4304|015|U|USES:  This product is used to treat and prevent symptoms||
4304|016|U|(wheezing and shortness of breath) caused by ongoing lung disease||
4304|017|U|(chronic obstructive pulmonary disease-COPD which includes||
4304|018|U|bronchitis and emphysema). This product contains 2 medications:||
4304|019|U|ipratropium and albuterol (also known as salbutamol). Both drugs||
4304|020|U|work by relaxing the muscles around the airways so that they open||
4304|021|U|up and you can breathe more easily. Controlling symptoms of||
4304|022|U|breathing problems can decrease time lost from work or school.||
4304|023|B|||
4304|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4304|025|H|from your pharmacist before you start using this product and each||
4304|026|H|time you get a refill. This medication is used with a special||
4304|027|H|machine called a nebulizer that changes the solution to a fine||
4304|028|H|mist that you inhale. Learn how to prepare the solution and use||
4304|029|H|the nebulizer properly. If a child is using this medication, a||
4304|030|H|parent or other responsible adult should supervise the child. If||
4304|031|H|you have any questions, ask your doctor, pharmacist, or||
4304|032|H|respiratory therapist.||
4304|033|H|   This product should be clear and colorless. Before using,||
4304|034|H|check this product for particles or discoloration. If either is||
4304|035|H|present, do not use the liquid.||
4304|036|H|   Inhale this medication into your lungs using the nebulizer as||
4304|037|H|directed by your doctor, usually 4 times a day. Avoid getting||
4304|038|H|this medication into your eyes. It may cause eye pain/irritation,||
4304|039|H|temporary blurred vision, and other vision changes. It is||
4304|040|H|recommended that you use a mouthpiece rather than a face mask||
4304|041|H|with the nebulizer or that you close your eyes during use. Each||
4304|042|H|treatment usually takes about 5 to 15 minutes. Use this||
4304|043|H|medication only through a nebulizer. Do not swallow or inject the||
4304|044|H|solution. To prevent infections, clean the nebulizer and||
4304|045|H|mouthpiece/face mask according to the manufacturer's directions.||
4304|046|H|   The US brand does not require any mixing before use. The||
4304|047|H|Canadian brand can be used unmixed or if directed, may be mixed||
4304|048|H|with sterile saline just before use. Once a vial is opened, throw||
4304|049|H|away any unused solution.||
4304|050|H|   The dosage is based on your medical condition and response to||
4304|051|H|treatment. Do not increase your dose or use this drug more often||
4304|052|H|than prescribed without your doctor's approval. Using too much of||
4304|053|H|this medication will increase your risk of serious (possibly||
4304|054|H|fatal) side effects.||
4304|055|H|   Rinse your mouth after treatment to prevent dry mouth and||
4304|056|H|throat irritation.||
4304|057|H|   Use this medication regularly to get the most benefit from it.||
4304|058|H|This medication works best if used at evenly spaced intervals. To||
4304|059|H|help you remember, use it at the same times each day.||
4304|060|H|   Learn which of your inhalers/medications you should use every||
4304|061|H|day and which you should use if your breathing suddenly worsens||
4304|062|H|(quick-relief drugs). Ask your doctor ahead of time what you||
4304|063|H|should do if you have new or worsening cough or shortness of||
4304|064|H|breath, wheezing, increased sputum, waking up at night with||
4304|065|H|trouble breathing, if you use your quick-relief inhaler more||
4304|066|H|often, or if your quick-relief inhaler does not seem to be||
4304|067|H|working well. Learn when you can treat sudden breathing problems||
4304|068|H|by yourself and when you must get medical help right away.||
4304|069|H|   Tell your doctor if your symptoms do not get better or if they||
4304|070|H|get worse.||
4304|071|B|||
4304|072|S|SIDE EFFECTS:  See also How to Use section.||
4304|073|S|   Headache, dizziness, nausea, dry mouth, shaking (tremors),||
4304|074|S|nervousness, or constipation may occur. If any of these effects||
4304|075|S|last or get worse, tell your doctor or pharmacist promptly.||
4304|076|S|   Remember that this medication has been prescribed because your||
4304|077|S|doctor has judged that the benefit to you is greater than the||
4304|078|S|risk of side effects. Many people using this medication do not||
4304|079|S|have serious side effects.||
4304|080|S|   This medication may raise your blood pressure. Check your||
4304|081|S|blood pressure regularly and tell your doctor if the results are||
4304|082|S|high.||
4304|083|S|   Rarely, this medication may cause severe sudden worsening of||
4304|084|S|breathing problems right after use. If you have sudden worsening||
4304|085|S|of breathing, get medical help right away.||
4304|086|S|   Tell your doctor right away if you have any serious side||
4304|087|S|effects, including: difficult/painful urination, muscle cramps.||
4304|088|S|   Get medical help right away if you have any very serious side||
4304|089|S|effects, including: chest pain, fast/pounding/irregular||
4304|090|S|heartbeat, rapid breathing, confusion, eye pain/swelling/redness,||
4304|091|S|vision changes (such as seeing rainbows around lights at night,||
4304|092|S|blurred vision).||
4304|093|S|   A very serious allergic reaction to this product is rare.||
4304|094|S|However, get medical help right away if you notice any symptoms||
4304|095|S|of a serious allergic reaction, including: rash, itching/swelling||
4304|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4304|097|S|breathing.||
4304|098|S|   This is not a complete list of possible side effects. If you||
4304|099|S|notice other effects not listed above, contact your doctor or||
4304|100|S|pharmacist.||
4304|101|S|   In the US -||
4304|102|S|   Call your doctor for medical advice about side effects. You||
4304|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4304|104|S|www.fda.gov/medwatch.||
4304|105|S|   In Canada - Call your doctor for medical advice about side||
4304|106|S|effects. You may report side effects to Health Canada at||
4304|107|S|1-866-234-2345.||
4304|108|B|||
4304|109|P|PRECAUTIONS:  Before using this product, tell your doctor or||
4304|110|P|pharmacist if you are allergic to ipratropium or albuterol||
4304|111|P|(salbutamol); or to tiotropium; or to atropine or other||
4304|112|P|belladonna-type drugs; or to levalbuterol; or if you have any||
4304|113|P|other allergies. This product may contain inactive ingredients,||
4304|114|P|which can cause allergic reactions or other problems. Talk to||
4304|115|P|your pharmacist for more details.||
4304|116|P|   Before using this medication, tell your doctor or pharmacist||
4304|117|P|your medical history, especially of: high blood pressure, heart||
4304|118|P|disease (such as chest pain, heart attack, irregular heartbeat),||
4304|119|P|personal or family history of glaucoma (angle-closure type),||
4304|120|P|difficulty urinating (for example, due to enlarged prostate),||
4304|121|P|seizure, overactive thyroid (hyperthyroidism), diabetes.||
4304|122|P|   This drug may make you dizzy or blur your vision or cause||
4304|123|P|vision changes. Alcohol or marijuana (cannabis) can make you more||
4304|124|P|dizzy. Do not drive, use machinery, or do anything that needs||
4304|125|P|alertness or clear vision until you can do it safely. Limit||
4304|126|P|alcoholic beverages. Talk to your doctor if you are using||
4304|127|P|marijuana (cannabis).||
4304|128|P|   Before having surgery, tell your doctor or dentist about all||
4304|129|P|the products you use (including prescription drugs,||
4304|130|P|nonprescription drugs, and herbal products).||
4304|131|P|   Older adults may be more sensitive to the side effects of this||
4304|132|P|drug, especially problems urinating or constipation.||
4304|133|P|   During pregnancy, this medication should be used only when||
4304|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
4304|135|P|   It is unknown if this medication passes into breast milk.||
4304|136|P|Consult your doctor before breastfeeding.||
4304|137|B|||
4304|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4304|139|I|medications work or increase your risk for serious side effects.||
4304|140|I|This document does not contain all possible drug interactions.||
4304|141|I|Keep a list of all the products you use (including||
4304|142|I|prescription/nonprescription drugs and herbal products) and share||
4304|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
4304|144|I|the dosage of any medicines without your doctor's approval.||
4304|145|I|   Albuterol is very similar to levalbuterol. Do not use||
4304|146|I|medications containing levalbuterol while using albuterol.||
4304|147|B|||
4304|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4304|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4304|150|O|poison control center right away. US residents can call||
4304|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4304|152|O|Symptoms of overdose may include: chest pain, fast/irregular||
4304|153|O|heartbeat, seizures.||
4304|154|B|||
4304|155|N|NOTES:  Do not share this medication with others.||
4304|156|N|   Lab and/or medical tests (such as lung function, blood||
4304|157|N|pressure) may be done while you are using this medication. Keep||
4304|158|N|all medical and lab appointments. Consult your doctor for more||
4304|159|N|details.||
4304|160|B|||
4304|161|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4304|162|D|If it is near the time of the next dose, skip the missed dose.||
4304|163|D|Use your next dose at the regular time. Do not double the dose to||
4304|164|D|catch up.||
4304|165|B|||
4304|166|R|STORAGE:  Different brands of this medication have different||
4304|167|R|storage needs. Check the product package for instructions on how||
4304|168|R|to store your brand, or ask your pharmacist. Keep all medications||
4304|169|R|away from children and pets.||
4304|170|R|   Do not flush medications down the toilet or pour them into a||
4304|171|R|drain unless instructed to do so. Properly discard this product||
4304|172|R|when it is expired or no longer needed. Consult your pharmacist||
4304|173|R|or local waste disposal company.||
4304|174|B|||
4304|175|M|MEDICAL ALERT:  Your condition can cause complications in a||
4304|176|M|medical emergency. For information about enrolling in MedicAlert,||
4304|177|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4304|178|B|||
4304|179|A|Information last revised February 2025.||
4304|180|A|Copyright(c) 2025 First Databank, Inc.||
4304|181|B|||
4309|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4309|002|Z|does NOT have all possible information about this product. This||
4309|003|Z|information does not assure that this product is safe, effective,||
4309|004|Z|or appropriate for you. This information is not individual||
4309|005|Z|medical advice and does not substitute for the advice of your||
4309|006|Z|health care professional. Always ask your health care||
4309|007|Z|professional for complete information about this product and your||
4309|008|Z|specific health needs.||
4309|009|B|||
4309|010|T|GLIPIZIDE/METFORMIN - ORAL||
4309|011|F|(GLIP-i-zide/met-FOR-min)||
4309|012|B|||
4309|013|C|COMMON BRAND NAME(S): Metaglip||
4309|014|B|||
4309|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
4309|016|W|cause a serious (sometimes fatal) condition called lactic||
4309|017|W|acidosis. Lactic acidosis is more likely if you are an older||
4309|018|W|adult, if you have kidney or liver disease, dehydration, heart||
4309|019|W|failure, heavy alcohol use, if you have surgery, if you have||
4309|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
4309|021|W|you are using certain drugs. For some conditions, your doctor may||
4309|022|W|tell you to stop taking this medication for a short time. Ask||
4309|023|W|your doctor or pharmacist for more details.||
4309|024|W|   Stop taking this medication and get medical help right away if||
4309|025|W|you have any symptoms of lactic acidosis, such as unusual||
4309|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
4309|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
4309|028|W|or stomach pain with nausea/vomiting/diarrhea.||
4309|029|B|||
4309|030|U|USES:  This diabetes medication is a combination of 2 drugs||
4309|031|U|(glipizide and metformin). It is used along with a diet and||
4309|032|U|exercise program to control high blood sugar in patients with||
4309|033|U|type 2 diabetes.||
4309|034|U|   Glipizide is a sulfonylurea and works by stimulating the||
4309|035|U|release of your body's natural insulin and by decreasing the||
4309|036|U|amount of sugar that your liver makes. Metformin is a biguanide||
4309|037|U|and works by decreasing the amount of sugar that your liver makes||
4309|038|U|and that your stomach/intestines absorb. Both of these||
4309|039|U|medications work by helping to restore your body's proper||
4309|040|U|response to the insulin you naturally produce.||
4309|041|U|   Controlling high blood sugar helps prevent kidney damage,||
4309|042|U|blindness, nerve problems, loss of limbs, and sexual function||
4309|043|U|problems. Proper control of diabetes may also lessen your risk of||
4309|044|U|a heart attack or stroke.||
4309|045|B|||
4309|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4309|047|H|from your pharmacist before you start using this medication and||
4309|048|H|each time you get a refill. If you have any questions, ask your||
4309|049|H|doctor or pharmacist.||
4309|050|H|   Take this medication by mouth as directed by your doctor,||
4309|051|H|usually once or twice a day with meals. Drink plenty of fluids||
4309|052|H|while taking this medication unless otherwise directed by your||
4309|053|H|doctor.||
4309|054|H|   The dosage is based on your medical condition, response to||
4309|055|H|treatment, and other medications you may be taking. Be sure to||
4309|056|H|tell your doctor and pharmacist about all the products you use||
4309|057|H|(including prescription drugs, nonprescription drugs, and herbal||
4309|058|H|products). To reduce your risk of side effects (such as upset||
4309|059|H|stomach), your doctor may direct you to start this medication at||
4309|060|H|a low dose and gradually increase your dose. Follow your doctor's||
4309|061|H|instructions carefully.||
4309|062|H|   Colesevelam can decrease the absorption of glipizide. If you||
4309|063|H|are taking colesevelam, take this product at least 4 hours before||
4309|064|H|taking colesevelam.||
4309|065|H|   Use this medication regularly in order to get the most benefit||
4309|066|H|from it. Remember to use it at the same time(s) each day.||
4309|067|H|   Tell your doctor if your condition lasts or gets worse (for||
4309|068|H|example, if you have high/low blood sugar). It may take up to 2||
4309|069|H|weeks before the full benefit of this drug takes effect.||
4309|070|B|||
4309|071|S|SIDE EFFECTS:  See also Warning section.||
4309|072|S|   Nausea, diarrhea, stomach upset, muscle aches, or headache may||
4309|073|S|occur. If any of these effects last or get worse, tell your||
4309|074|S|doctor or pharmacist promptly. If stomach symptoms return later||
4309|075|S|(after you are on the same dose for several days or weeks), tell||
4309|076|S|your doctor right away. Stomach symptoms that occur after the||
4309|077|S|first days of your treatment may be a sign of lactic acidosis.||
4309|078|S|   Remember that this medication has been prescribed because your||
4309|079|S|doctor has judged that the benefit to you is greater than the||
4309|080|S|risk of side effects. Many people using this medication do not||
4309|081|S|have serious side effects.||
4309|082|S|   Tell your doctor right away if you have any serious side||
4309|083|S|effects, including: nausea that doesn't stop, easy||
4309|084|S|bleeding/bruising, signs of infection (such as sore throat that||
4309|085|S|doesn't go away, fever, chills), severe stomach/abdominal pain,||
4309|086|S|yellowing eyes/skin, dark urine.||
4309|087|S|   This medication can cause low blood sugar (hypoglycemia). This||
4309|088|S|may occur if you do not get enough calories from food or if you||
4309|089|S|do unusually heavy exercise. Symptoms of low blood sugar include||
4309|090|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
4309|091|S|dizziness, or tingling hands/feet. It is a good habit to carry||
4309|092|S|glucose tablets or gel to treat low blood sugar. If you don't||
4309|093|S|have these reliable forms of glucose, rapidly raise your blood||
4309|094|S|sugar by eating a quick source of sugar such as table sugar,||
4309|095|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
4309|096|S|doctor right away about the reaction and the use of this product.||
4309|097|S|To help prevent low blood sugar, eat meals on a regular schedule,||
4309|098|S|and do not skip meals. Check with your doctor or pharmacist to||
4309|099|S|find out what you should do if you miss a meal.||
4309|100|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
4309|101|S|thirst/urination. If these symptoms occur, tell your doctor right||
4309|102|S|away. Your doctor may need to adjust your diabetes medication,||
4309|103|S|exercise program, or diet.||
4309|104|S|   A very serious allergic reaction to this drug is rare.||
4309|105|S|However, get medical help right away if you notice any symptoms||
4309|106|S|of a serious allergic reaction, including: rash, itching/swelling||
4309|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4309|108|S|breathing.||
4309|109|S|   This is not a complete list of possible side effects. If you||
4309|110|S|notice other effects not listed above, contact your doctor or||
4309|111|S|pharmacist.||
4309|112|S|   In the US -||
4309|113|S|   Call your doctor for medical advice about side effects. You||
4309|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4309|115|S|www.fda.gov/medwatch.||
4309|116|S|   In Canada - Call your doctor for medical advice about side||
4309|117|S|effects. You may report side effects to Health Canada at||
4309|118|S|1-866-234-2345.||
4309|119|B|||
4309|120|P|PRECAUTIONS:  See also Warning section.||
4309|121|P|   Before taking this medication, tell your doctor or pharmacist||
4309|122|P|if you are allergic to glipizide or metformin; or if you have any||
4309|123|P|other allergies. This product may contain inactive ingredients,||
4309|124|P|which can cause allergic reactions or other problems. Talk to||
4309|125|P|your pharmacist for more details.||
4309|126|P|   Before using this medication, tell your doctor or pharmacist||
4309|127|P|your medical history, especially of: alcohol use, severe||
4309|128|P|breathing problems (such as obstructive lung disease, severe||
4309|129|P|asthma), blood problems (such as anemia, vitamin B12 deficiency),||
4309|130|P|electrolyte imbalance (hyponatremia), fertility problems (such as||
4309|131|P|ovulation problems), kidney disease, certain hormonal conditions||
4309|132|P|(adrenal/pituitary insufficiency, thyroid disease, syndrome of||
4309|133|P|inappropriate antidiuretic hormone-SIADH).||
4309|134|P|   Before having surgery or any X-ray/scanning procedure using||
4309|135|P|iodinated contrast, tell your doctor or dentist about all the||
4309|136|P|products you use (including prescription drugs, nonprescription||
4309|137|P|drugs, and herbal products). You may need to stop this medication||
4309|138|P|for a short time for the surgery/procedure. Ask your doctor or||
4309|139|P|dentist for instructions before your surgery/procedure.||
4309|140|P|   You may experience blurred vision, dizziness, or drowsiness||
4309|141|P|due to extremely low or high blood sugar. Do not drive, use||
4309|142|P|machinery, or do anything that needs alertness or clear vision||
4309|143|P|until you can do it safely.||
4309|144|P|   Limit alcohol while taking this medication because it can||
4309|145|P|increase the risk of developing hypoglycemia and lactic acidosis.||
4309|146|P|Rarely, alcohol can interact with glipizide and cause a serious||
4309|147|P|reaction (disulfiram-like reaction) with symptoms such as facial||
4309|148|P|flushing, nausea, vomiting, dizziness, or stomach pain. Consult||
4309|149|P|your doctor or pharmacist about using alcohol safely.||
4309|150|P|   It may be harder to control your blood sugar when your body is||
4309|151|P|stressed (such as due to fever, infection, injury, or surgery).||
4309|152|P|Consult your doctor because this may require a change in your||
4309|153|P|treatment plan, medications, or blood sugar testing.||
4309|154|P|   This medication may make you more sensitive to the sun. Limit||
4309|155|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4309|156|P|sunscreen and wear protective clothing when outdoors. Tell your||
4309|157|P|doctor right away if you get sunburned or have skin||
4309|158|P|blisters/redness.||
4309|159|P|   Older adults may be at greater risk for lactic acidosis or low||
4309|160|P|blood sugar while using this drug.||
4309|161|P|   This medication can cause changes in the menstrual cycle||
4309|162|P|(promote ovulation) and increase the risk of becoming pregnant.||
4309|163|P|Consult your doctor or pharmacist about the use of reliable birth||
4309|164|P|control while using this medication.||
4309|165|P|   During pregnancy, this medication should be used only when||
4309|166|P|clearly needed. Discuss the risks and benefits with your doctor.||
4309|167|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
4309|168|P|your doctor for managing your blood sugar while pregnant. Your||
4309|169|P|doctor may change your diabetes treatment during your pregnancy||
4309|170|P|(such as diet and medications including insulin).||
4309|171|P|   This drug passes into breast milk and could have undesirable||
4309|172|P|effects on a nursing infant. Consult your doctor before||
4309|173|P|breastfeeding.||
4309|174|B|||
4309|175|I|DRUG INTERACTIONS:  See also How to Use section.||
4309|176|I|   Drug interactions may change how your medications work or||
4309|177|I|increase your risk for serious side effects. This document does||
4309|178|I|not contain all possible drug interactions. Keep a list of all||
4309|179|I|the products you use (including prescription/nonprescription||
4309|180|I|drugs and herbal products) and share it with your doctor and||
4309|181|I|pharmacist. Do not start, stop, or change the dosage of any||
4309|182|I|medicines without your doctor's approval.||
4309|183|I|   Many drugs can affect your blood sugar, making it harder to||
4309|184|I|control. Before you start, stop, or change any medication, talk||
4309|185|I|with your doctor or pharmacist about how the medication may||
4309|186|I|affect your blood sugar. Check your blood sugar regularly as||
4309|187|I|directed and share the results with your doctor. Tell your doctor||
4309|188|I|right away if you have symptoms of high or low blood sugar. (See||
4309|189|I|also Side Effects section.) Your doctor may need to adjust your||
4309|190|I|diabetes medication, exercise program, or diet.||
4309|191|I|   Beta-blocker medications (such as metoprolol, propranolol,||
4309|192|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
4309|193|I|heartbeat you would usually feel when your blood sugar falls too||
4309|194|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
4309|195|I|dizziness, hunger, or sweating are unaffected by these drugs.||
4309|196|B|||
4309|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4309|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4309|199|O|poison control center right away. US residents can call||
4309|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4309|201|O|Overdose can cause lactic acidosis and low blood sugar. Symptoms||
4309|202|O|of overdose may include: rapid breathing, severe drowsiness,||
4309|203|O|slow/irregular heartbeat.||
4309|204|B|||
4309|205|N|NOTES:  Do not share this medication with others.||
4309|206|N|   Attend a diabetes education program to learn more about how to||
4309|207|N|manage your diabetes with medications, diet, exercise, and||
4309|208|N|regular medical exams.||
4309|209|N|   Learn the symptoms of high and low blood sugar and how to||
4309|210|N|treat low blood sugar. Check your blood sugar regularly as||
4309|211|N|directed and share the results with your doctor.||
4309|212|N|   Lab and/or medical tests (such as kidney function, liver||
4309|213|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
4309|214|N|should be done before you start taking this medication and while||
4309|215|N|you are taking it. Keep all medical and lab appointments. Consult||
4309|216|N|your doctor for more details.||
4309|217|B|||
4309|218|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
4309|219|D|you remember. If it is near the time of the next dose, skip the||
4309|220|D|missed dose. Take your next dose at the regular time. Do not||
4309|221|D|double the dose to catch up.||
4309|222|B|||
4309|223|R|STORAGE:  Store at room temperature away from light and moisture.||
4309|224|R|Do not store in the bathroom. Keep all medications away from||
4309|225|R|children and pets.||
4309|226|R|   Do not flush medications down the toilet or pour them into a||
4309|227|R|drain unless instructed to do so. Properly discard this product||
4309|228|R|when it is expired or no longer needed. Consult your pharmacist||
4309|229|R|or local waste disposal company.||
4309|230|B|||
4309|231|M|MEDICAL ALERT:  Your condition can cause complications in a||
4309|232|M|medical emergency. For information about enrolling in MedicAlert,||
4309|233|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4309|234|B|||
4309|235|A|Information last revised November 2025.||
4309|236|A|Copyright(c) 2025 First Databank, Inc.||
4309|237|B|||
4310|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4310|002|Z|does NOT have all possible information about this product. This||
4310|003|Z|information does not assure that this product is safe, effective,||
4310|004|Z|or appropriate for you. This information is not individual||
4310|005|Z|medical advice and does not substitute for the advice of your||
4310|006|Z|health care professional. Always ask your health care||
4310|007|Z|professional for complete information about this product and your||
4310|008|Z|specific health needs.||
4310|009|B|||
4310|010|T|ALENDRONATE 70 MG WEEKLY SOLUTION - ORAL||
4310|011|F|(a-LEN-droe-nate)||
4310|012|B|||
4310|013|C|COMMON BRAND NAME(S): Fosamax||
4310|014|B|||
4310|015|U|USES:  Alendronate is used to treat certain types of bone loss||
4310|016|U|(osteoporosis) in adults. Osteoporosis causes bones to become||
4310|017|U|thinner and break more easily. This medication works by slowing||
4310|018|U|bone loss. This effect helps maintain strong bones and reduce the||
4310|019|U|risk of broken bones (fractures). Alendronate belongs to a class||
4310|020|U|of drugs called bisphosphonates.||
4310|021|B|||
4310|022|H|HOW TO USE:  Read the Medication Guide provided by your||
4310|023|H|pharmacist before you start taking alendronate and each time you||
4310|024|H|get a refill. Follow the instructions very closely to make sure||
4310|025|H|your body absorbs as much drug as possible and to reduce the risk||
4310|026|H|of injury to your esophagus. If you have any questions, ask your||
4310|027|H|doctor or pharmacist.||
4310|028|H|   Take this medication by mouth as directed by your doctor,||
4310|029|H|usually once a week. Choose the day of the week that best fits||
4310|030|H|your schedule and take it on that day each week.||
4310|031|H|   Take this medication after getting up for the day and before||
4310|032|H|taking your first food, beverage, or other medication. Drink at||
4310|033|H|least 2 ounces (60 milliliters) of plain water after taking||
4310|034|H|liquid alendronate. Then stay fully upright (sitting, standing,||
4310|035|H|or walking) for at least 30 minutes and do not lie down until||
4310|036|H|after your first food of the day. Alendronate works only if taken||
4310|037|H|on an empty stomach. Wait at least 30 minutes (preferably 1 to 2||
4310|038|H|hours) after taking the medication before you eat or drink||
4310|039|H|anything other than plain water.||
4310|040|H|   Do not take this medication at bedtime or before rising for||
4310|041|H|the day. It may not be absorbed and you may have side effects.||
4310|042|H|   Calcium or iron supplements, vitamins, antacids, coffee, tea,||
4310|043|H|soda, mineral water, juice with added calcium, and food can||
4310|044|H|decrease the absorption of alendronate. Do not take these for at||
4310|045|H|least 30 minutes (preferably 1 to 2 hours) after taking||
4310|046|H|alendronate.||
4310|047|H|   Take this medication regularly to get the most benefit from||
4310|048|H|it. To help you remember, take it on the same day each week. Mark||
4310|049|H|your calendar with a reminder. Talk to your doctor about the||
4310|050|H|risks and benefits of long-term use of this medication.||
4310|051|B|||
4310|052|S|SIDE EFFECTS:  Stomach pain, constipation, diarrhea, gas, or||
4310|053|S|nausea may occur. If any of these effects last or get worse, tell||
4310|054|S|your doctor or pharmacist promptly.||
4310|055|S|   Remember that this medication has been prescribed because your||
4310|056|S|doctor has judged that the benefit to you is greater than the||
4310|057|S|risk of side effects. Many people using this medication do not||
4310|058|S|have serious side effects.||
4310|059|S|   Tell your doctor right away if you have any serious side||
4310|060|S|effects, including: jaw/ear pain, swelling of||
4310|061|S|joints/hands/ankles/feet, increased or severe bone/joint/muscle||
4310|062|S|pain, new or unusual hip/thigh/groin pain, black/tarry stools,||
4310|063|S|vomit that looks like coffee grounds.||
4310|064|S|   This medication may rarely cause serious irritation and ulcers||
4310|065|S|of the esophagus. If you notice any of the following unlikely but||
4310|066|S|very serious side effects, stop taking alendronate and talk to||
4310|067|S|your doctor or pharmacist right away: new or worsening heartburn,||
4310|068|S|chest pain, pain or difficulty when swallowing.||
4310|069|S|   A very serious allergic reaction to this drug is rare.||
4310|070|S|However, get medical help right away if you notice any symptoms||
4310|071|S|of a serious allergic reaction, including: rash, itching/swelling||
4310|072|S|(especially of the face/tongue/throat), dizziness, trouble||
4310|073|S|breathing.||
4310|074|S|   This is not a complete list of possible side effects. If you||
4310|075|S|notice other effects not listed above, contact your doctor or||
4310|076|S|pharmacist.||
4310|077|S|   In the US -||
4310|078|S|   Call your doctor for medical advice about side effects. You||
4310|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4310|080|S|www.fda.gov/medwatch.||
4310|081|S|   In Canada - Call your doctor for medical advice about side||
4310|082|S|effects. You may report side effects to Health Canada at||
4310|083|S|1-866-234-2345.||
4310|084|B|||
4310|085|P|PRECAUTIONS:  Before taking alendronate, tell your doctor or||
4310|086|P|pharmacist if you are allergic to it; or to other||
4310|087|P|bisphosphonates; or if you have any other allergies. This product||
4310|088|P|may contain inactive ingredients, which can cause allergic||
4310|089|P|reactions or other problems. Talk to your pharmacist for more||
4310|090|P|details.||
4310|091|P|   Before using this medication, tell your doctor or pharmacist||
4310|092|P|your medical history, especially of: disorders of the esophagus||
4310|093|P|(such as esophageal stricture or achalasia), trouble swallowing,||
4310|094|P|trouble standing or sitting upright for at least 30 minutes, low||
4310|095|P|calcium levels, kidney problems, stomach/intestinal disorders||
4310|096|P|(such as ulcers).||
4310|097|P|   Some people taking alendronate may have serious jawbone||
4310|098|P|problems. Your doctor should check your mouth before you start||
4310|099|P|this medication. Tell your dentist that you are taking this||
4310|100|P|medication before you have any dental work done. To help prevent||
4310|101|P|jawbone problems, have regular dental exams and learn how to keep||
4310|102|P|your teeth and gums healthy. If you have jaw pain, tell your||
4310|103|P|doctor and dentist right away.||
4310|104|P|   Before having any surgery (especially dental procedures), tell||
4310|105|P|your doctor and dentist about this medication and all other||
4310|106|P|products you use (including prescription drugs, nonprescription||
4310|107|P|drugs, and herbal products). Your doctor or dentist may tell you||
4310|108|P|to stop taking alendronate before your surgery. Follow all||
4310|109|P|instructions about stopping or starting this medication.||
4310|110|P|   This drug is not recommended for use in children. Studies have||
4310|111|P|shown that many children who took this drug had severe side||
4310|112|P|effects such as vomiting, fever, and flu-like symptoms.||
4310|113|P|   Tell your doctor if you are pregnant or plan to become||
4310|114|P|pregnant. Alendronate may stay in your body for many years. You||
4310|115|P|should not become pregnant while using alendronate. Discuss the||
4310|116|P|risks and benefits with your doctor.||
4310|117|P|   It is unknown if this medication passes into breast milk.||
4310|118|P|Consult your doctor before breastfeeding.||
4310|119|B|||
4310|120|I|DRUG INTERACTIONS:  See also How to Use section.||
4310|121|I|   Drug interactions may change how your medications work or||
4310|122|I|increase your risk for serious side effects. This document does||
4310|123|I|not contain all possible drug interactions. Keep a list of all||
4310|124|I|the products you use (including prescription/nonprescription||
4310|125|I|drugs and herbal products) and share it with your doctor and||
4310|126|I|pharmacist. Do not start, stop, or change the dosage of any||
4310|127|I|medicines without your doctor's approval.||
4310|128|B|||
4310|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4310|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4310|131|O|poison control center right away. US residents can call||
4310|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4310|133|O|Symptoms of overdose may include: severe stomach pain, painful||
4310|134|O|heartburn, pain in the esophagus (chest pain), muscle||
4310|135|O|weakness/cramps, mental/mood changes.||
4310|136|B|||
4310|137|N|NOTES:  Do not share this medication with others.||
4310|138|N|   Lifestyle changes that help promote healthy bones include||
4310|139|N|increasing weight-bearing exercise, stopping smoking, limiting||
4310|140|N|alcohol, and eating well-balanced meals that contain adequate||
4310|141|N|calcium and vitamin D. You may also need to take calcium and||
4310|142|N|vitamin D supplements. Consult your doctor for specific advice.||
4310|143|N|   Lab and/or medical tests (X-rays, height measurement, blood||
4310|144|N|mineral levels) should be done while you are taking this||
4310|145|N|medication. Keep all medical and lab appointments. Consult your||
4310|146|N|doctor for more details.||
4310|147|B|||
4310|148|D|MISSED DOSE:  If you miss a dose, take it the next morning after||
4310|149|D|you remember. Then go back to your weekly dosing schedule on your||
4310|150|D|usual day of the week. Do not take two doses on the same day.||
4310|151|B|||
4310|152|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
4310|153|R|medications away from children and pets.||
4310|154|R|   Do not flush medications down the toilet or pour them into a||
4310|155|R|drain unless instructed to do so. Properly discard this product||
4310|156|R|when it is expired or no longer needed. Consult your pharmacist||
4310|157|R|or local waste disposal company.||
4310|158|B|||
4310|159|A|Information last revised September 2025.||
4310|160|A|Copyright(c) 2025 First Databank, Inc.||
4310|161|B|||
4312|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4312|002|Z|does NOT have all possible information about this product. This||
4312|003|Z|information does not assure that this product is safe, effective,||
4312|004|Z|or appropriate for you. This information is not individual||
4312|005|Z|medical advice and does not substitute for the advice of your||
4312|006|Z|health care professional. Always ask your health care||
4312|007|Z|professional for complete information about this product and your||
4312|008|Z|specific health needs.||
4312|009|B|||
4312|010|T|HAWTHORN (Crataegus laevigata) - ORAL||
4312|011|B|||
4312|012|U|USES:  Hawthorn has been used for heart failure, chest pain||
4312|013|U|(angina), and high blood pressure. You should see a doctor for||
4312|014|U|these conditions before using this product.||
4312|015|U|   Some herbal/diet supplement products have been found to||
4312|016|U|contain possibly harmful impurities/additives. Check with your||
4312|017|U|pharmacist for more details about the brand you use.||
4312|018|U|   The FDA has not reviewed this product for safety or||
4312|019|U|effectiveness. Consult your doctor or pharmacist for more||
4312|020|U|details.||
4312|021|B|||
4312|022|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
4312|023|H|directions and warnings on the product package. If you have any||
4312|024|H|questions, ask your doctor or pharmacist.||
4312|025|H|   If your condition lasts or gets worse, or if you think you may||
4312|026|H|have a serious medical problem, get medical help right away.||
4312|027|B|||
4312|028|S|SIDE EFFECTS:  Nausea, stomach upset, dizziness, drowsiness,||
4312|029|S|sweating, trouble sleeping, or headache may occur. If any of||
4312|030|S|these effects last or get worse, tell your doctor or pharmacist||
4312|031|S|promptly.||
4312|032|S|   Tell your doctor right away if you have any serious side||
4312|033|S|effects, including: fast/pounding heartbeat, shortness of breath,||
4312|034|S|mental/mood changes (such as agitation).||
4312|035|S|   A very serious allergic reaction to this product is rare.||
4312|036|S|However, get medical help right away if you notice any symptoms||
4312|037|S|of a serious allergic reaction, including: rash, itching/swelling||
4312|038|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4312|039|S|breathing.||
4312|040|S|   This is not a complete list of possible side effects. If you||
4312|041|S|notice other effects not listed above, contact your doctor or||
4312|042|S|pharmacist.||
4312|043|S|   In the US -||
4312|044|S|   Call your doctor for medical advice about side effects. You||
4312|045|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4312|046|S|www.fda.gov/medwatch.||
4312|047|S|   In Canada - Call your doctor for medical advice about side||
4312|048|S|effects. You may report side effects to Health Canada at||
4312|049|S|1-866-234-2345.||
4312|050|B|||
4312|051|P|PRECAUTIONS:  Before taking hawthorn, tell your doctor or||
4312|052|P|pharmacist if you are allergic to it; or if you have any other||
4312|053|P|allergies. This product may contain inactive ingredients, which||
4312|054|P|can cause allergic reactions or other problems. Talk to your||
4312|055|P|pharmacist for more details.||
4312|056|P|   If you have any of the following health problems, consult your||
4312|057|P|doctor or pharmacist before using this product: heart disease||
4312|058|P|(such as heart failure, angina), low blood pressure.||
4312|059|P|   This product may make you dizzy or drowsy. Alcohol or||
4312|060|P|marijuana (cannabis) can make you more dizzy or drowsy. Do not||
4312|061|P|drive, use machinery, or do anything that needs alertness until||
4312|062|P|you can do it safely. Limit alcoholic beverages. Talk to your||
4312|063|P|doctor if you are using marijuana (cannabis).||
4312|064|P|   Liquid forms of this product may contain sugar and/or alcohol.||
4312|065|P|Caution is advised if you have diabetes, alcohol dependence, or||
4312|066|P|liver disease. Ask your doctor or pharmacist about using this||
4312|067|P|product safely.||
4312|068|P|   Hawthorn is not recommended for use during pregnancy. Consult||
4312|069|P|your doctor for more details.||
4312|070|P|   It is unknown if this product passes into breast milk. Consult||
4312|071|P|your doctor before breastfeeding.||
4312|072|B|||
4312|073|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4312|074|I|medications work or increase your risk for serious side effects.||
4312|075|I|This document does not contain all possible drug interactions.||
4312|076|I|Keep a list of all the products you use (including||
4312|077|I|prescription/nonprescription drugs and herbal products) and share||
4312|078|I|it with your doctor and pharmacist. Do not start, stop, or change||
4312|079|I|the dosage of any medicines without your doctor's approval.||
4312|080|I|   Some drugs that may interact with this product are: alpha||
4312|081|I|blockers (such as prazosin), drugs to treat erectile||
4312|082|I|dysfunction-ED or pulmonary hypertension (such as sildenafil,||
4312|083|I|tadalafil), drugs to treat high blood pressure (including beta||
4312|084|I|blockers such as atenolol, calcium channel blockers such as||
4312|085|I|diltiazem), heart medications (including digoxin, nitrates such||
4312|086|I|as isosorbide dinitrate).||
4312|087|I|   Tell your doctor or pharmacist if you are taking other||
4312|088|I|products that cause drowsiness such as opioid pain or cough||
4312|089|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4312|090|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4312|091|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4312|092|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
4312|093|I|diphenhydramine).||
4312|094|I|   Check the labels on all your medicines (such as allergy or||
4312|095|I|cough-and-cold products) because they may contain ingredients||
4312|096|I|that cause drowsiness. Ask your pharmacist about using those||
4312|097|I|products safely.||
4312|098|B|||
4312|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4312|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4312|101|O|poison control center right away. US residents can call||
4312|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4312|103|O|Symptoms of overdose may include: severe dizziness, severe||
4312|104|O|drowsiness.||
4312|105|B|||
4312|106|N|NOTES:  Keep all medical and lab appointments.||
4312|107|B|||
4312|108|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4312|109|D|remember. If it is near the time of the next dose, skip the||
4312|110|D|missed dose. Take your next dose at the regular time. Do not||
4312|111|D|double the dose to catch up.||
4312|112|B|||
4312|113|R|STORAGE:  Refer to storage information printed on the package. If||
4312|114|R|you have any questions about storage, ask your pharmacist. Keep||
4312|115|R|all medications and herbal products away from children and pets.||
4312|116|R|   Do not flush medications down the toilet or pour them into a||
4312|117|R|drain unless instructed to do so. Properly discard this product||
4312|118|R|when it is expired or no longer needed. Consult your pharmacist||
4312|119|R|or local waste disposal company.||
4312|120|B|||
4312|121|A|Information last revised May 2024.||
4312|122|A|Copyright(c) 2025 First Databank, Inc.||
4312|123|B|||
4317|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4317|002|Z|does NOT have all possible information about this product. This||
4317|003|Z|information does not assure that this product is safe, effective,||
4317|004|Z|or appropriate for you. This information is not individual||
4317|005|Z|medical advice and does not substitute for the advice of your||
4317|006|Z|health care professional. Always ask your health care||
4317|007|Z|professional for complete information about this product and your||
4317|008|Z|specific health needs.||
4317|009|B|||
4317|010|T|CIPROFLOXACIN SUSTAINED-RELEASE - ORAL||
4317|011|F|(SIP-roe-FLOX-a-sin)||
4317|012|B|||
4317|013|C|COMMON BRAND NAME(S): Cipro XR||
4317|014|B|||
4317|015|W|WARNING:  Quinolone antibiotics (including ciprofloxacin) may||
4317|016|W|cause serious and possibly permanent tendon damage (such as||
4317|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
4317|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
4317|019|W|help right away if you have any of the following symptoms:||
4317|020|W|pain/numbness/burning/tingling/weakness in your||
4317|021|W|arms/hands/legs/feet, changes in how you sense||
4317|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
4317|023|W|headache, vision changes, shaking (tremors), seizures,||
4317|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
4317|025|W|hallucinations, depression, rare thoughts of suicide).||
4317|026|W|   Tendon damage may occur during or after treatment with this||
4317|027|W|medication. Stop exercising, rest, and get medical help right||
4317|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
4317|029|W|risk for tendon problems is greater if you are over 60 years of||
4317|030|W|age, if you are taking corticosteroids (such as prednisone), or||
4317|031|W|if you have a kidney, heart, or lung transplant.||
4317|032|W|   This medication may make a certain muscle condition||
4317|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
4317|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
4317|035|W|unsteady walk) or trouble breathing.||
4317|036|W|   Discuss the risks and benefits with your doctor before using||
4317|037|W|this medication.||
4317|038|B|||
4317|039|U|USES:  This medication is used to treat kidney or urinary tract||
4317|040|U|infections. Ciprofloxacin belongs to a class of drugs called||
4317|041|U|quinolone antibiotics. It works by stopping the growth of||
4317|042|U|bacteria.||
4317|043|U|   This antibiotic treats only bacterial infections. It will not||
4317|044|U|work for virus infections (such as common cold, flu). Using any||
4317|045|U|antibiotic when it is not needed can cause it to not work for||
4317|046|U|future infections.||
4317|047|B|||
4317|048|H|HOW TO USE:  Read the Medication Guide and, if available, the||
4317|049|H|Patient Information Leaflet provided by your pharmacist before||
4317|050|H|you start taking ciprofloxacin and each time you get a refill. If||
4317|051|H|you have any questions, ask your doctor or pharmacist.||
4317|052|H|   Take this medication by mouth with or without food as directed||
4317|053|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
4317|054|H|not crush or chew the tablets. Doing so can release all of the||
4317|055|H|drug at once, increasing the risk of side effects.||
4317|056|H|   The dosage and length of treatment is based on your medical||
4317|057|H|condition and response to treatment. Drink plenty of fluids while||
4317|058|H|taking this medication unless your doctor tells you otherwise.||
4317|059|H|   Take this medication at least 2 hours before or 6 hours after||
4317|060|H|taking other products that may bind to it, decreasing its||
4317|061|H|effectiveness. Ask your pharmacist about the other products you||
4317|062|H|take. Some examples include: quinapril, sevelamer, sucralfate,||
4317|063|H|vitamins/minerals (including iron and zinc supplements), and||
4317|064|H|products containing magnesium, aluminum, or calcium (such as||
4317|065|H|antacids, calcium supplements).||
4317|066|H|   Calcium-rich foods, including dairy products (such as milk,||
4317|067|H|yogurt) or juice with added calcium, can also decrease the effect||
4317|068|H|of this medication. Take this medication at least 2 hours before||
4317|069|H|or 6 hours after eating calcium-rich foods, unless you are eating||
4317|070|H|these foods as part of a larger meal that contains other||
4317|071|H|(non-calcium-rich) foods. These other foods decrease the calcium||
4317|072|H|binding effect.||
4317|073|H|   Ciprofloxacin may increase and/or prolong the effects of||
4317|074|H|caffeine. Avoid drinking large amounts of beverages containing||
4317|075|H|caffeine (coffee, tea, colas), eating large amounts of chocolate,||
4317|076|H|or taking nonprescription products that contain caffeine.||
4317|077|H|   Ask your doctor or pharmacist about safely using nutritional||
4317|078|H|supplements/replacements with this medication.||
4317|079|H|   For the best effect, take this antibiotic at evenly spaced||
4317|080|H|times. To help you remember, take this medication at the same||
4317|081|H|time(s) every day.||
4317|082|H|   Continue to take this medication until the full prescribed||
4317|083|H|amount is finished, even if symptoms disappear after a few days.||
4317|084|H|Stopping the medication too early may result in a return of the||
4317|085|H|infection.||
4317|086|H|   Tell your doctor if your condition lasts or gets worse.||
4317|087|B|||
4317|088|S|SIDE EFFECTS:  See also Warning section.||
4317|089|S|   Nausea, diarrhea, dizziness, lightheadedness, headache, or||
4317|090|S|trouble sleeping may occur. If any of these effects last or get||
4317|091|S|worse, tell your doctor or pharmacist promptly.||
4317|092|S|   Remember that this medication has been prescribed because your||
4317|093|S|doctor has judged that the benefit to you is greater than the||
4317|094|S|risk of side effects. Many people using this medication do not||
4317|095|S|have serious side effects.||
4317|096|S|   Tell your doctor right away if you have any serious side||
4317|097|S|effects, including: unusual bruising/bleeding, signs of a new||
4317|098|S|infection (such as sore throat that doesn't go away, fever),||
4317|099|S|signs of kidney problems (such as change in the amount of urine,||
4317|100|S|red/pink urine), signs of liver problems (such as nausea/vomiting||
4317|101|S|that doesn't stop, unusual tiredness, stomach/abdominal pain,||
4317|102|S|yellowing eyes/skin, dark urine).||
4317|103|S|   Get medical help right away if you have any very serious side||
4317|104|S|effects, including: severe dizziness, fainting, fast/irregular||
4317|105|S|heartbeat, signs of a tear/break in the main blood vessel called||
4317|106|S|the aorta (such as sudden/severe pain in the stomach/chest/back,||
4317|107|S|shortness of breath).||
4317|108|S|   This medication may rarely cause a severe intestinal condition||
4317|109|S|due to a bacteria called C. difficile. This condition may occur||
4317|110|S|during treatment or weeks to months after treatment has stopped.||
4317|111|S|Tell your doctor right away if you develop: diarrhea that doesn't||
4317|112|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
4317|113|S|stool.||
4317|114|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
4317|115|S|products because they may make symptoms worse.||
4317|116|S|   Use of this medication for prolonged or repeated periods may||
4317|117|S|result in oral thrush or a new yeast infection. Contact your||
4317|118|S|doctor if you notice white patches in your mouth, a change in||
4317|119|S|vaginal discharge, or other new symptoms.||
4317|120|S|   A very serious allergic reaction to this drug is rare.||
4317|121|S|However, get medical help right away if you notice any symptoms||
4317|122|S|of a serious allergic reaction, including: rash, itching/swelling||
4317|123|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4317|124|S|breathing.||
4317|125|S|   This is not a complete list of possible side effects. If you||
4317|126|S|notice other effects not listed above, contact your doctor or||
4317|127|S|pharmacist.||
4317|128|S|   In the US -||
4317|129|S|   Call your doctor for medical advice about side effects. You||
4317|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4317|131|S|www.fda.gov/medwatch.||
4317|132|S|   In Canada - Call your doctor for medical advice about side||
4317|133|S|effects. You may report side effects to Health Canada at||
4317|134|S|1-866-234-2345.||
4317|135|B|||
4317|136|P|PRECAUTIONS:  Before taking ciprofloxacin, tell your doctor or||
4317|137|P|pharmacist if you are allergic to it; or to other quinolone||
4317|138|P|antibiotics such as norfloxacin, gemifloxacin, levofloxacin,||
4317|139|P|moxifloxacin, or ofloxacin; or if you have any other allergies.||
4317|140|P|This product may contain inactive ingredients, which can cause||
4317|141|P|allergic reactions or other problems. Talk to your pharmacist for||
4317|142|P|more details.||
4317|143|P|   Before using this medication, tell your doctor or pharmacist||
4317|144|P|your medical history, especially of: diabetes, heart problems||
4317|145|P|(such as recent heart attack), joint/tendon problems (such as||
4317|146|P|tendonitis, bursitis), kidney disease, liver disease, mental/mood||
4317|147|P|disorders (such as depression), myasthenia gravis, nerve problems||
4317|148|P|(such as peripheral neuropathy), seizures, conditions that||
4317|149|P|increase your risk of seizures (such as brain/head injury, brain||
4317|150|P|tumors, cerebral atherosclerosis), blood vessel problems (such as||
4317|151|P|aneurysm or blockage of the aorta or other blood vessels,||
4317|152|P|hardening of the arteries), high blood pressure, certain genetic||
4317|153|P|conditions (Marfan syndrome, Ehlers-Danlos syndrome).||
4317|154|P|   Ciprofloxacin may cause a condition that affects the heart||
4317|155|P|rhythm (QT prolongation). QT prolongation can rarely cause||
4317|156|P|serious (rarely fatal) fast/irregular heartbeat and other||
4317|157|P|symptoms (such as severe dizziness, fainting) that need medical||
4317|158|P|attention right away.||
4317|159|P|   The risk of QT prolongation may be increased if you have||
4317|160|P|certain medical conditions or are taking other drugs that may||
4317|161|P|cause QT prolongation. Before using ciprofloxacin, tell your||
4317|162|P|doctor or pharmacist of all the drugs you take and if you have||
4317|163|P|any of the following conditions: certain heart problems (heart||
4317|164|P|failure, slow heartbeat, QT prolongation in the EKG), family||
4317|165|P|history of certain heart problems (QT prolongation in the EKG,||
4317|166|P|sudden cardiac death).||
4317|167|P|   Low levels of potassium or magnesium in the blood may also||
4317|168|P|increase your risk of QT prolongation. This risk may increase if||
4317|169|P|you use certain drugs (such as diuretics/"water pills") or if you||
4317|170|P|have conditions such as severe sweating, diarrhea, or vomiting.||
4317|171|P|Talk to your doctor about using ciprofloxacin safely.||
4317|172|P|   This medication may rarely cause serious changes in blood||
4317|173|P|sugar, especially if you have diabetes. Check your blood sugar||
4317|174|P|regularly as directed and share the results with your doctor.||
4317|175|P|Watch for symptoms of high blood sugar such as increased||
4317|176|P|thirst/urination. Ciprofloxacin may increase the||
4317|177|P|blood-sugar-lowering effects of the medication glyburide. Also||
4317|178|P|watch for symptoms of low blood sugar such as sudden sweating,||
4317|179|P|shaking, fast heartbeat, hunger, blurred vision, dizziness, or||
4317|180|P|tingling hands/feet. It is a good habit to carry glucose tablets||
4317|181|P|or gel to treat low blood sugar. If you don't have these reliable||
4317|182|P|forms of glucose, rapidly raise your blood sugar by eating a||
4317|183|P|quick source of sugar such as table sugar, honey, or candy, or by||
4317|184|P|drinking fruit juice or non- diet soda. Tell your doctor right||
4317|185|P|away about the reaction and the use of this product. To help||
4317|186|P|prevent low blood sugar, eat meals on a regular schedule, and do||
4317|187|P|not skip meals. Your doctor may need to switch you to another||
4317|188|P|antibiotic or adjust your diabetes medications if any reaction||
4317|189|P|occurs.||
4317|190|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4317|191|P|can make you more dizzy. Do not drive, use machinery, or do||
4317|192|P|anything that needs alertness until you can do it safely. Limit||
4317|193|P|alcoholic beverages. Talk to your doctor if you are using||
4317|194|P|marijuana (cannabis).||
4317|195|P|   This medication may make you more sensitive to the sun. Limit||
4317|196|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4317|197|P|sunscreen and wear protective clothing when outdoors. Tell your||
4317|198|P|doctor right away if you get sunburned or have skin||
4317|199|P|blisters/redness.||
4317|200|P|   Ciprofloxacin may cause live bacterial vaccines (such as||
4317|201|P|typhoid vaccine) to not work well. Tell your health care||
4317|202|P|professional that you are using ciprofloxacin before having any||
4317|203|P|immunizations/vaccinations.||
4317|204|P|   Before having surgery, tell your doctor or dentist about all||
4317|205|P|the products you use (including prescription drugs,||
4317|206|P|nonprescription drugs, and herbal products).||
4317|207|P|   Children may be more sensitive to the side effects of this||
4317|208|P|drug, especially joint/tendon problems.||
4317|209|P|   Older adults may be at greater risk for tendon problems||
4317|210|P|(especially if they are also taking corticosteroids such as||
4317|211|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
4317|212|P|tear/break in the main blood vessel (aorta).||
4317|213|P|   During pregnancy, this medication should be used only when||
4317|214|P|clearly needed. Discuss the risks and benefits with your doctor.||
4317|215|P|   This medication passes into breast milk and may have||
4317|216|P|undesirable effects on a nursing infant. Consult your doctor||
4317|217|P|before breastfeeding.||
4317|218|B|||
4317|219|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
4317|220|I|   Drug interactions may change how your medications work or||
4317|221|I|increase your risk for serious side effects. This document does||
4317|222|I|not contain all possible drug interactions. Keep a list of all||
4317|223|I|the products you use (including prescription/nonprescription||
4317|224|I|drugs and herbal products) and share it with your doctor and||
4317|225|I|pharmacist. Do not start, stop, or change the dosage of any||
4317|226|I|medicines without your doctor's approval.||
4317|227|I|   Some products that may interact with this drug include: "blood||
4317|228|I|thinners" (such as acenocoumarol, warfarin), strontium.||
4317|229|I|   Many drugs besides ciprofloxacin may affect the heart rhythm||
4317|230|I|(QT prolongation), including amiodarone, dofetilide, quinidine,||
4317|231|I|procainamide, sotalol, among others.||
4317|232|I|   This medication can slow down the removal of other medications||
4317|233|I|from your body, which may affect how they work. Examples of||
4317|234|I|affected drugs include duloxetine, fezolinetant, pirfenidone,||
4317|235|I|tasimelteon, tizanidine, vorasidenib, among others.||
4317|236|B|||
4317|237|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4317|238|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4317|239|O|poison control center right away. US residents can call||
4317|240|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4317|241|B|||
4317|242|N|NOTES:  Do not share this medication with others.||
4317|243|N|   This medication has been prescribed for your current condition||
4317|244|N|only. Do not use it later for another infection unless your||
4317|245|N|doctor tells you to.||
4317|246|N|   Lab and/or medical tests (such as kidney function, blood||
4317|247|N|counts, cultures) should be done while you are taking this||
4317|248|N|medication. Keep all medical and lab appointments. Consult your||
4317|249|N|doctor for more details.||
4317|250|N|   Do not change brands of this medication without asking your||
4317|251|N|doctor or pharmacist. Not all brands have the same effects.||
4317|252|B|||
4317|253|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4317|254|D|remember. If it is less than 8 hours before the next dose, skip||
4317|255|D|the missed dose. Take your next dose at the regular time. Do not||
4317|256|D|double the dose to catch up.||
4317|257|B|||
4317|258|R|STORAGE:  Store at room temperature away from light and moisture.||
4317|259|R|Do not store in the bathroom. Keep all medications away from||
4317|260|R|children and pets.||
4317|261|R|   Do not flush medications down the toilet or pour them into a||
4317|262|R|drain unless instructed to do so. Properly discard this product||
4317|263|R|when it is expired or no longer needed. Consult your pharmacist||
4317|264|R|or local waste disposal company.||
4317|265|B|||
4317|266|A|Information last revised September 2025.||
4317|267|A|Copyright(c) 2025 First Databank, Inc.||
4317|268|B|||
4321|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4321|002|Z|does NOT have all possible information about this product. This||
4321|003|Z|information does not assure that this product is safe, effective,||
4321|004|Z|or appropriate for you. This information is not individual||
4321|005|Z|medical advice and does not substitute for the advice of your||
4321|006|Z|health care professional. Always ask your health care||
4321|007|Z|professional for complete information about this product and your||
4321|008|Z|specific health needs.||
4321|009|B|||
4321|010|T|GATIFLOXACIN - OPHTHALMIC||
4321|011|F|(gat-ih-FLOX-uh-sin)||
4321|012|B|||
4321|013|C|COMMON BRAND NAME(S): Zymar||
4321|014|B|||
4321|015|U|USES:  This medication is a quinolone antibiotic used for eye||
4321|016|U|infections (such as conjunctivitis).||
4321|017|U|   This medication treats only bacterial eye infections. It will||
4321|018|U|not work for other types of eye infections. Unnecessary use or||
4321|019|U|misuse of any antibiotic can lead to its decreased effectiveness.||
4321|020|B|||
4321|021|H|HOW TO USE:  Use this medication in the affected eye(s) as||
4321|022|H|directed by your doctor, usually 3 times a day for the first 2||
4321|023|H|days and then 2 times a day for the next 5 days.||
4321|024|H|   For best results, use exactly as directed for the full time||
4321|025|H|prescribed. Stopping this medication too soon may result in a||
4321|026|H|return of the infection.||
4321|027|H|   To apply eye drops, wash hands first. To avoid contamination,||
4321|028|H|do not touch the dropper tip or let it touch your eye or any||
4321|029|H|other surface.||
4321|030|H|   Tilt your head back, gaze upward and pull down the lower||
4321|031|H|eyelid to make a pouch. Place the dropper directly over eye and||
4321|032|H|instill the prescribed number of drops. Look downward and gently||
4321|033|H|close your eye for 1 to 2 minutes. Place one finger at the corner||
4321|034|H|of the eye near the nose and apply gentle pressure. This will||
4321|035|H|prevent the medication from draining away from the eye. Try not||
4321|036|H|to blink and do not rub the eye. Do not rinse the dropper.||
4321|037|H|   If you are using other kinds of eye drops, wait at least five||
4321|038|H|minutes before applying the other medications.||
4321|039|H|   Wait several minutes for your vision to clear before driving||
4321|040|H|or operating machinery.||
4321|041|H|   Do not wear contact lenses while you are using this medicine.||
4321|042|H|Sterilize contact lenses according to manufacturer's directions||
4321|043|H|and check with your doctor before using them.||
4321|044|H|   Tell your doctor if your condition does not get better in 7||
4321|045|H|days.||
4321|046|B|||
4321|047|S|SIDE EFFECTS:  Blurred vision, watery eyes, headache, eye||
4321|048|S|irritation/pain/dryness/redness, bad taste in mouth may occur. If||
4321|049|S|any of these effects last or get worse, tell your doctor or||
4321|050|S|pharmacist promptly.||
4321|051|S|   Remember that this medication has been prescribed because your||
4321|052|S|doctor has judged that the benefit to you is greater than the||
4321|053|S|risk of side effects. Many people using this medication do not||
4321|054|S|have serious side effects.||
4321|055|S|   Tell your doctor right away if you have any serious side||
4321|056|S|effects, including: eye redness that doesn't go away, swelling of||
4321|057|S|the eye or eyelid.||
4321|058|S|   Use of this medication for prolonged or repeated periods may||
4321|059|S|result in a new fungal eye infection. Do not use this medication||
4321|060|S|for longer than prescribed. Contact your doctor if you notice new||
4321|061|S|or worsening symptoms.||
4321|062|S|   A very serious allergic reaction to this drug is rare.||
4321|063|S|However, get medical help right away if you notice any symptoms||
4321|064|S|of a serious allergic reaction, including: rash, itching/swelling||
4321|065|S|(especially of the face/tongue/throat), dizziness, trouble||
4321|066|S|breathing.||
4321|067|S|   This is not a complete list of possible side effects. If you||
4321|068|S|notice other effects not listed above, contact your doctor or||
4321|069|S|pharmacist.||
4321|070|S|   In the US -||
4321|071|S|   Call your doctor for medical advice about side effects. You||
4321|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4321|073|S|www.fda.gov/medwatch.||
4321|074|S|   In Canada - Call your doctor for medical advice about side||
4321|075|S|effects. You may report side effects to Health Canada at||
4321|076|S|1-866-234-2345.||
4321|077|B|||
4321|078|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
4321|079|P|pharmacist if you are allergic to it; or to quinolone antibiotics||
4321|080|P|(such as ciprofloxacin); or if you have any other allergies. This||
4321|081|P|product may contain inactive ingredients, which can cause||
4321|082|P|allergic reactions or other problems. Talk to your pharmacist for||
4321|083|P|more details.||
4321|084|P|   Before using this medication, tell your doctor or pharmacist||
4321|085|P|your medical history.||
4321|086|P|   After you apply this drug, your vision may become temporarily||
4321|087|P|blurred. Do not drive, use machinery, or do anything that needs||
4321|088|P|clear vision until you can do it safely.||
4321|089|P|   During pregnancy, this medication should be used only when||
4321|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
4321|091|P|   It is unknown if this medication passes into breast milk.||
4321|092|P|Consult your doctor before breastfeeding.||
4321|093|B|||
4321|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4321|095|I|medications work or increase your risk for serious side effects.||
4321|096|I|This document does not contain all possible drug interactions.||
4321|097|I|Keep a list of all the products you use (including||
4321|098|I|prescription/nonprescription drugs and herbal products) and share||
4321|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
4321|100|I|the dosage of any medicines without your doctor's approval.||
4321|101|B|||
4321|102|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
4321|103|O|has overdosed and has serious symptoms such as passing out or||
4321|104|O|trouble breathing, call 911. Otherwise, call a poison control||
4321|105|O|center right away. US residents can call 1-800-222-1222. Canada||
4321|106|O|residents can call 1-844-764-7669.||
4321|107|B|||
4321|108|N|NOTES:  This medication has been prescribed for your current||
4321|109|N|condition only. Do not use it later for another infection unless||
4321|110|N|your doctor tells you to.||
4321|111|N|   Do not share this medication with others.||
4321|112|B|||
4321|113|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4321|114|D|If it is near the time of the next dose, skip the missed dose.||
4321|115|D|Use your next dose at the regular time. Do not double the dose to||
4321|116|D|catch up.||
4321|117|B|||
4321|118|R|STORAGE:  Different brands of this medication have different||
4321|119|R|storage needs. Check the product package for instructions on how||
4321|120|R|to store your brand, or ask your pharmacist. Keep all medications||
4321|121|R|away from children and pets.||
4321|122|R|   Do not flush medications down the toilet or pour them into a||
4321|123|R|drain unless instructed to do so. Properly discard this product||
4321|124|R|when it is expired or no longer needed. Consult your pharmacist||
4321|125|R|or local waste disposal company.||
4321|126|B|||
4321|127|A|Information last revised November 2024.||
4321|128|A|Copyright(c) 2025 First Databank, Inc.||
4321|129|B|||
4326|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4326|002|Z|does NOT have all possible information about this product. This||
4326|003|Z|information does not assure that this product is safe, effective,||
4326|004|Z|or appropriate for you. This information is not individual||
4326|005|Z|medical advice and does not substitute for the advice of your||
4326|006|Z|health care professional. Always ask your health care||
4326|007|Z|professional for complete information about this product and your||
4326|008|Z|specific health needs.||
4326|009|B|||
4326|010|T|GRISEOFULVIN SUSPENSION - ORAL||
4326|011|F|(GRISS-ee-oh-FULL-vin)||
4326|012|B|||
4326|013|C|COMMON BRAND NAME(S): Grifulvin V||
4326|014|B|||
4326|015|U|USES:  This medication is used to treat fungal infections of the||
4326|016|U|skin, hair, and nails that do not respond to creams/lotions.||
4326|017|U|Clearing such infections will get rid of symptoms such as||
4326|018|U|itching, red/peeling/scaly skin, and discolored nails. This||
4326|019|U|medication works by stopping the growth of fungi. It does not||
4326|020|U|treat infections due to bacteria or yeast.||
4326|021|B|||
4326|022|H|HOW TO USE:  Shake the bottle well before each dose. Take this||
4326|023|H|medication by mouth as directed by your doctor. For the best||
4326|024|H|absorption, it is best taken with or after a meal containing a||
4326|025|H|moderate amount of fat. Talk to your doctor or pharmacist about||
4326|026|H|specific dietary instructions, especially if you are on a low-fat||
4326|027|H|diet.||
4326|028|H|   The dosage is based on your medical condition and response to||
4326|029|H|treatment. Children's dosage is also based on weight. The length||
4326|030|H|of treatment depends on the type of infection you have. It may||
4326|031|H|take several weeks to months to complete treatment for infections||
4326|032|H|of the scalp, feet, and body. Nail infections may require several||
4326|033|H|months to a year or longer to treat.||
4326|034|H|   Antifungal medications work best when the amount of medicine||
4326|035|H|in your body is kept at a constant level. Take this drug at||
4326|036|H|evenly spaced intervals.||
4326|037|H|   Continue to take this medication for the full time prescribed,||
4326|038|H|even if symptoms disappear after a few days. Stopping the||
4326|039|H|medication too early may result in a return of the infection.||
4326|040|H|   Tell your doctor if your condition lasts or gets worse.||
4326|041|B|||
4326|042|S|SIDE EFFECTS:  Headache, nausea, vomiting, diarrhea, stomach||
4326|043|S|upset, tiredness, dizziness, or trouble sleeping may occur. If||
4326|044|S|any of these effects last or get worse, tell your doctor or||
4326|045|S|pharmacist promptly.||
4326|046|S|   Remember that this medication has been prescribed because your||
4326|047|S|doctor has judged that the benefit to you is greater than the||
4326|048|S|risk of side effects. Many people using this medication do not||
4326|049|S|have serious side effects.||
4326|050|S|   Tell your doctor right away if you have any serious side||
4326|051|S|effects, including: numbness/tingling of the hands/feet,||
4326|052|S|mental/mood changes (such as confusion, trouble doing normal||
4326|053|S|activities), hearing changes, butterfly-shaped facial rash||
4326|054|S|(around the nose and cheeks), joint/muscle pain, signs of liver||
4326|055|S|disease (such as nausea/vomiting that doesn't stop,||
4326|056|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
4326|057|S|of kidney problems (such as change in the amount of urine, frothy||
4326|058|S|urine), signs of infection (such as sore throat that doesn't go||
4326|059|S|away, fever, chills).||
4326|060|S|   Use of this medication for prolonged or repeated periods may||
4326|061|S|result in oral thrush or a new vaginal yeast infection (oral or||
4326|062|S|vaginal fungal infection). Contact your doctor if you notice||
4326|063|S|white patches in your mouth, a change in vaginal discharge, or||
4326|064|S|other new symptoms.||
4326|065|S|   A very serious allergic reaction to this drug is rare.||
4326|066|S|However, get medical help right away if you notice any symptoms||
4326|067|S|of a serious allergic reaction, including: rash, itching/swelling||
4326|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4326|069|S|breathing.||
4326|070|S|   This is not a complete list of possible side effects. If you||
4326|071|S|notice other effects not listed above, contact your doctor or||
4326|072|S|pharmacist.||
4326|073|S|   In the US -||
4326|074|S|   Call your doctor for medical advice about side effects. You||
4326|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4326|076|S|www.fda.gov/medwatch.||
4326|077|S|   In Canada - Call your doctor for medical advice about side||
4326|078|S|effects. You may report side effects to Health Canada at||
4326|079|S|1-866-234-2345.||
4326|080|B|||
4326|081|P|PRECAUTIONS:  Before taking griseofulvin, tell your doctor or||
4326|082|P|pharmacist if you are allergic to it; or if you have any other||
4326|083|P|allergies. This product may contain inactive ingredients, which||
4326|084|P|can cause allergic reactions or other problems. Talk to your||
4326|085|P|pharmacist for more details.||
4326|086|P|   Before using this medication, tell your doctor or pharmacist||
4326|087|P|your medical history, especially of: a certain blood disorder||
4326|088|P|(porphyria), liver disease, lupus.||
4326|089|P|   This drug may make you dizzy or less alert. Alcohol or||
4326|090|P|marijuana (cannabis) can make you more dizzy or much less alert.||
4326|091|P|Do not drive, use machinery, or do anything that needs alertness||
4326|092|P|until you can do it safely. Avoid alcoholic beverages while you||
4326|093|P|are taking this drug unless your doctor gives permission.||
4326|094|P|Drinking alcohol during treatment with this drug could result in||
4326|095|P|a fast heartbeat and flushing of the skin. Talk to your doctor if||
4326|096|P|you are using marijuana (cannabis).||
4326|097|P|   This medication may make you more sensitive to the sun. Limit||
4326|098|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
4326|099|P|sunscreen and wear protective clothing when outdoors. Tell your||
4326|100|P|doctor right away if you get sunburned or have skin||
4326|101|P|blisters/redness.||
4326|102|P|   Tell your doctor if you are pregnant or plan to become||
4326|103|P|pregnant. You should not become pregnant while using||
4326|104|P|griseofulvin. Griseofulvin may harm an unborn baby. Ask about||
4326|105|P|reliable forms of birth control while using this medication and||
4326|106|P|for 1 month after the last dose. If you become pregnant, talk to||
4326|107|P|your doctor right away about the risks and benefits of this||
4326|108|P|medication. (See also Drug Interactions section.)||
4326|109|P|   The effects of this drug on human sperm are unknown. However,||
4326|110|P|based on animal cell studies, the manufacturer recommends waiting||
4326|111|P|for a period of time after completing griseofulvin treatment||
4326|112|P|before trying to father a child. Discuss the risks and benefits||
4326|113|P|with your doctor, and ask how long to wait after your last dose||
4326|114|P|before trying to father a child.||
4326|115|P|   It is unknown if this drug passes into breast milk. Consult||
4326|116|P|your doctor before breastfeeding.||
4326|117|B|||
4326|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4326|119|I|medications work or increase your risk for serious side effects.||
4326|120|I|This document does not contain all possible drug interactions.||
4326|121|I|Keep a list of all the products you use (including||
4326|122|I|prescription/nonprescription drugs and herbal products) and share||
4326|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
4326|124|I|the dosage of any medicines without your doctor's approval.||
4326|125|I|   Some products that may interact with this drug are:||
4326|126|I|barbiturates (such as phenobarbital), warfarin.||
4326|127|I|   This medication may decrease the effectiveness of hormonal||
4326|128|I|birth control such as pills, patch, or ring. This could cause||
4326|129|I|pregnancy. Discuss with your doctor or pharmacist if you should||
4326|130|I|use reliable backup birth control methods while using this||
4326|131|I|medication. Also tell your doctor if you have any new spotting or||
4326|132|I|breakthrough bleeding, because these may be signs that your birth||
4326|133|I|control is not working well.||
4326|134|B|||
4326|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4326|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4326|137|O|poison control center right away. US residents can call||
4326|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4326|139|B|||
4326|140|N|NOTES:  Do not share this medication with others.||
4326|141|N|   This medication has been prescribed for your current condition||
4326|142|N|only. Do not use it later for another infection unless your||
4326|143|N|doctor tells you to.||
4326|144|N|   Lab and/or medical tests (such as kidney/liver function,||
4326|145|N|complete blood count) should be done while you are taking this||
4326|146|N|medication. Keep all medical and lab appointments. Consult your||
4326|147|N|doctor for more details.||
4326|148|N|   Ask your doctor or pharmacist about ways to control the||
4326|149|N|infection and to prevent re-infection. Fungus spreads easily in||
4326|150|N|warm, moist areas. Follow good hygiene (for example wash and dry||
4326|151|N|the infected area completely, and do not share articles of||
4326|152|N|clothing or objects that come in contact with the infected area).||
4326|153|B|||
4326|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4326|155|D|remember. If it is near the time of the next dose, skip the||
4326|156|D|missed dose. Take your next dose at the regular time. Do not||
4326|157|D|double the dose to catch up.||
4326|158|B|||
4326|159|R|STORAGE:  Store at room temperature. Keep all medications away||
4326|160|R|from children and pets.||
4326|161|R|   Do not flush medications down the toilet or pour them into a||
4326|162|R|drain unless instructed to do so. Properly discard this product||
4326|163|R|when it is expired or no longer needed. Consult your pharmacist||
4326|164|R|or local waste disposal company.||
4326|165|B|||
4326|166|A|Information last revised May 2025.||
4326|167|A|Copyright(c) 2025 First Databank, Inc.||
4326|168|B|||
4330|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4330|002|Z|does NOT have all possible information about this product. This||
4330|003|Z|information does not assure that this product is safe, effective,||
4330|004|Z|or appropriate for you. This information is not individual||
4330|005|Z|medical advice and does not substitute for the advice of your||
4330|006|Z|health care professional. Always ask your health care||
4330|007|Z|professional for complete information about this product and your||
4330|008|Z|specific health needs.||
4330|009|B|||
4330|010|T|ATAZANAVIR - ORAL||
4330|011|F|(A-ta-ZAN-a-vir)||
4330|012|B|||
4330|013|C|COMMON BRAND NAME(S): Reyataz||
4330|014|B|||
4330|015|U|USES:  This drug is used with other HIV medications to help||
4330|016|U|control HIV infection. It helps to decrease the amount of HIV in||
4330|017|U|your body so your immune system can work better. This lowers your||
4330|018|U|chance of getting HIV complications (such as new infections,||
4330|019|U|cancer) and improves your quality of life.||
4330|020|U|   Atazanavir belongs to a class of drugs known as protease||
4330|021|U|inhibitors. It may be given with certain other medications (such||
4330|022|U|as cobicistat, ritonavir) to increase ("boost") the levels of||
4330|023|U|atazanavir. This helps atazanavir work better.||
4330|024|U|   Atazanavir is not a cure for HIV infection. To decrease your||
4330|025|U|risk of spreading HIV disease to others, continue to take all HIV||
4330|026|U|medications exactly as prescribed by your doctor. Use an||
4330|027|U|effective barrier method (latex or polyurethane condoms/dental||
4330|028|U|dams) during sexual activity as directed by your doctor. Do not||
4330|029|U|share personal items (such as needles/syringes, toothbrushes, and||
4330|030|U|razors) that may have contacted blood or other body fluids.||
4330|031|U|Consult your doctor or pharmacist for more details.||
4330|032|B|||
4330|033|V|OTHER USES:  This section contains uses of this drug that are not||
4330|034|V|listed in the approved professional labeling for the drug but||
4330|035|V|that may be prescribed by your health care professional. Use this||
4330|036|V|drug for a condition that is listed in this section only if it||
4330|037|V|has been so prescribed by your health care professional.||
4330|038|V|   This product may also be used to lessen the risk of HIV||
4330|039|V|infection after contact with the virus (for example, due to a||
4330|040|V|needle stick). Ask your doctor for more details.||
4330|041|B|||
4330|042|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4330|043|H|from your pharmacist before you start taking atazanavir and each||
4330|044|H|time you get a refill. If you have any questions, ask your doctor||
4330|045|H|or pharmacist.||
4330|046|H|   Take this medication by mouth as directed by your doctor,||
4330|047|H|usually once daily with food. Do not open, crush, or chew the||
4330|048|H|capsules. Swallow the capsules whole.||
4330|049|H|   If you are taking atazanavir with certain other medications||
4330|050|H|(such as cobicistat, ritonavir), take them at the same time.||
4330|051|H|   Since this medication may cause kidney problems, drink plenty||
4330|052|H|of fluids during treatment to lower your risk.||
4330|053|H|   The dosage is based on your medical condition, response to||
4330|054|H|treatment, and other medications you may be taking. Children's||
4330|055|H|dosage is also based on weight. Be sure to tell your doctor and||
4330|056|H|pharmacist about all the products you use (including prescription||
4330|057|H|drugs, nonprescription drugs, and herbal products). If you are||
4330|058|H|directed to take ritonavir with this medication, take them both||
4330|059|H|at the same time.||
4330|060|H|   If you are taking antacids or buffered forms of drugs (such as||
4330|061|H|buffered aspirin), take atazanavir at least 2 hours before or 1||
4330|062|H|hour after these medications.||
4330|063|H|   For the best effect, take this medication at evenly spaced||
4330|064|H|times. To help you remember, take this medication at the same||
4330|065|H|time every day.||
4330|066|H|   It is very important to keep taking this medication (and other||
4330|067|H|HIV medications) exactly as prescribed by your doctor. Do not||
4330|068|H|skip any doses. Do not take more or less of this drug than||
4330|069|H|prescribed or stop taking it (or other HIV medicines) even for a||
4330|070|H|short time unless directed to do so by your doctor. Doing so may||
4330|071|H|cause the amount of virus to increase, make the infection more||
4330|072|H|difficult to treat (resistant), or worsen side effects.||
4330|073|B|||
4330|074|S|SIDE EFFECTS:  Headache or nausea may occur. If either of these||
4330|075|S|effects lasts or gets worse, tell your doctor or pharmacist||
4330|076|S|promptly.||
4330|077|S|   Remember that this medication has been prescribed because your||
4330|078|S|doctor has judged that the benefit to you is greater than the||
4330|079|S|risk of side effects. Many people using this medication do not||
4330|080|S|have serious side effects.||
4330|081|S|   As your immune system gets stronger, it can begin to fight off||
4330|082|S|infections you already had, possibly causing disease symptoms to||
4330|083|S|come back. You could also have symptoms if your immune system||
4330|084|S|becomes overactive. This reaction may happen at any time (soon||
4330|085|S|after starting HIV treatment or many months later). Tell your||
4330|086|S|doctor right away if you have any serious symptoms, including:||
4330|087|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
4330|088|S|that doesn't go away, headaches that are severe or don't go away,||
4330|089|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
4330|090|S|changes, signs of infection (such as sore throat that doesn't go||
4330|091|S|away, fever, chills, swollen lymph nodes, non-healing skin||
4330|092|S|sores), signs of an overactive thyroid (such as irritability,||
4330|093|S|nervousness, heat intolerance, fast/pounding/irregular||
4330|094|S|heartbeat).||
4330|095|S|   Tell your doctor right away if you have any serious side||
4330|096|S|effects, including: increased thirst/urination, dizziness,||
4330|097|S|lightheadedness, signs of kidney problems (such as pain in||
4330|098|S|side/back/abdomen, painful urination, blood in the urine, change||
4330|099|S|in the amount of urine), signs of liver problems (such as||
4330|100|S|nausea/vomiting that doesn't stop, loss of appetite,||
4330|101|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
4330|102|S|   Changes in body fat may occur while you are taking this||
4330|103|S|medication (such as increased fat in the upper back and stomach||
4330|104|S|areas, decreased fat in the arms and legs). The cause and||
4330|105|S|long-term effects of these changes are unknown. Discuss the risks||
4330|106|S|and benefits of treatment with your doctor, as well as the||
4330|107|S|possible use of exercise to reduce this side effect.||
4330|108|S|   Get medical help right away if you have any very serious side||
4330|109|S|effects, including: signs of a heart attack (such as||
4330|110|S|chest/jaw/left arm pain, shortness of breath, unusual sweating).||
4330|111|S|   Atazanavir can commonly cause a rash that is usually not||
4330|112|S|serious. However, you may not be able to tell it apart from a||
4330|113|S|rare rash that could be a sign of a severe reaction. Get medical||
4330|114|S|help right away if you develop any rash.||
4330|115|S|   A very serious allergic reaction to this drug is rare.||
4330|116|S|However, get medical help right away if you notice any symptoms||
4330|117|S|of a serious allergic reaction, including: rash, itching/swelling||
4330|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4330|119|S|breathing.||
4330|120|S|   This is not a complete list of possible side effects. If you||
4330|121|S|notice other effects not listed above, contact your doctor or||
4330|122|S|pharmacist.||
4330|123|S|   In the US -||
4330|124|S|   Call your doctor for medical advice about side effects. You||
4330|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4330|126|S|www.fda.gov/medwatch.||
4330|127|S|   In Canada - Call your doctor for medical advice about side||
4330|128|S|effects. You may report side effects to Health Canada at||
4330|129|S|1-866-234-2345.||
4330|130|B|||
4330|131|P|PRECAUTIONS:  Before taking atazanavir, tell your doctor or||
4330|132|P|pharmacist if you are allergic to it; or if you have any other||
4330|133|P|allergies. This product may contain inactive ingredients, which||
4330|134|P|can cause allergic reactions or other problems. Talk to your||
4330|135|P|pharmacist for more details.||
4330|136|P|   Before using this medication, tell your doctor or pharmacist||
4330|137|P|your medical history, especially of: liver problems (including||
4330|138|P|hepatitis B or C infections), kidney problems (including kidney||
4330|139|P|stones), heart problems (such as heart rhythm problems, irregular||
4330|140|P|heartbeat, coronary artery disease, heart attack), diabetes, a||
4330|141|P|certain bleeding problem (hemophilia).||
4330|142|P|   Atazanavir may increase the level of cholesterol and fats||
4330|143|P|(triglycerides) in your blood. HIV infection can also cause this||
4330|144|P|effect. This could increase your risk for heart problems such as||
4330|145|P|a heart attack. Discuss the risks and benefits of treatment with||
4330|146|P|your doctor and ways to lower your risk of heart disease. Tell||
4330|147|P|your doctor if you have heart problems, if you smoke, or if you||
4330|148|P|have other conditions that increase your risk of heart disease||
4330|149|P|such as high blood pressure, diabetes, or high||
4330|150|P|cholesterol/triglyceride levels.||
4330|151|P|   Before having surgery, tell your doctors or dentist about all||
4330|152|P|the products you use (including prescription drugs,||
4330|153|P|nonprescription drugs, and herbal products).||
4330|154|P|   Atazanavir should not be given to children younger than 3||
4330|155|P|months because of the risk of very serious side effects.||
4330|156|P|   Tell your doctor if you are pregnant before using this||
4330|157|P|medication. Treatment can lower the risk of passing HIV infection||
4330|158|P|to your baby. Discuss the risks and benefits with your doctor.||
4330|159|P|   This medication passes into breast milk. Because breast milk||
4330|160|P|may transmit HIV, consult your doctor before breastfeeding.||
4330|161|B|||
4330|162|I|DRUG INTERACTIONS:  See also How to Use section.||
4330|163|I|   Drug interactions may change how your medications work or||
4330|164|I|increase your risk for serious side effects. This document does||
4330|165|I|not contain all possible drug interactions. Keep a list of all||
4330|166|I|the products you use (including prescription/nonprescription||
4330|167|I|drugs and herbal products) and share it with your doctor and||
4330|168|I|pharmacist. Do not start, stop, or change the dosage of any||
4330|169|I|medicines without your doctor's approval.||
4330|170|I|   Some products that may interact with this drug include:||
4330|171|I|certain medications used to treat chronic hepatitis C (such as||
4330|172|I|elbasvir/grazoprevir, glecaprevir/pibrentasvir), a certain||
4330|173|I|combination HIV medication||
4330|174|I|(elvitegravir/cobicistat/emtricitabine/tenofovir), nevirapine,||
4330|175|I|orlistat.||
4330|176|I|   Other medications can affect the removal of atazanavir from||
4330|177|I|your body, which may affect how atazanavir works. Examples||
4330|178|I|include apalutamide, bosentan, efavirenz, etravirine, lumacaftor,||
4330|179|I|certain rifamycins (such as rifampin, rifapentine), certain drugs||
4330|180|I|used to treat seizures (such as carbamazepine, phenobarbital,||
4330|181|I|phenytoin, primidone), St. John's wort, among others.||
4330|182|I|   Atazanavir can slow down the removal of other medications from||
4330|183|I|your body, which may affect how they work. Examples of affected||
4330|184|I|drugs include certain alpha blockers (such as alfuzosin,||
4330|185|I|silodosin), certain benzodiazepines (midazolam, triazolam), ergot||
4330|186|I|alkaloids (such as dihydroergotamine, ergotamine), irinotecan,||
4330|187|I|lomitapide, pimozide, certain drugs to treat erectile||
4330|188|I|dysfunction-ED or pulmonary hypertension (such as avanafil,||
4330|189|I|sildenafil), certain "statin" cholesterol drugs (lovastatin,||
4330|190|I|simvastatin), salmeterol, among others.||
4330|191|I|   Prescription and nonprescription drugs to treat heartburn,||
4330|192|I|indigestion, or ulcers (including H2 blockers such as famotidine,||
4330|193|I|proton pump inhibitors such as lansoprazole/omeprazole) reduce||
4330|194|I|stomach acid and decrease the absorption of atazanavir. This may||
4330|195|I|prevent atazanavir from working well. Ask your doctor or||
4330|196|I|pharmacist how to use these medications safely.||
4330|197|I|   This medication may decrease the effectiveness of hormonal||
4330|198|I|birth control such as pills, patch, or ring. This could cause||
4330|199|I|pregnancy. Discuss with your doctor or pharmacist if you should||
4330|200|I|use reliable backup birth control methods while using this||
4330|201|I|medication. Also tell your doctor if you have any new spotting or||
4330|202|I|breakthrough bleeding, because these may be signs that your birth||
4330|203|I|control is not working well.||
4330|204|B|||
4330|205|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4330|206|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4330|207|O|poison control center right away. US residents can call||
4330|208|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4330|209|O|Symptoms of overdose may include: severe dizziness,||
4330|210|O|lightheadedness.||
4330|211|B|||
4330|212|N|NOTES:  Do not share this medication with others.||
4330|213|N|   Lab and/or medical tests (such as viral load, T-cell counts,||
4330|214|N|kidney/liver function, cholesterol/triglyceride levels, blood||
4330|215|N|sugar levels) should be done while you are taking this||
4330|216|N|medication. Keep all medical and lab appointments. Consult your||
4330|217|N|doctor for more details.||
4330|218|B|||
4330|219|D|MISSED DOSE:  It is important not to miss doses of this drug. If||
4330|220|D|you miss a dose, take it as soon as you remember. If it is less||
4330|221|D|than 6 hours before the next dose, skip the missed dose. Take||
4330|222|D|your next dose at the regular time. Do not double the dose to||
4330|223|D|catch up.||
4330|224|B|||
4330|225|R|STORAGE:  Store at room temperature away from light and moisture.||
4330|226|R|Do not store in the bathroom. Keep all medications away from||
4330|227|R|children and pets.||
4330|228|R|   Do not flush medications down the toilet or pour them into a||
4330|229|R|drain unless instructed to do so. Properly discard this product||
4330|230|R|when it is expired or no longer needed. Consult your pharmacist||
4330|231|R|or local waste disposal company.||
4330|232|B|||
4330|233|A|Information last revised April 2025.||
4330|234|A|Copyright(c) 2025 First Databank, Inc.||
4330|235|B|||
4333|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4333|002|Z|does NOT have all possible information about this product. This||
4333|003|Z|information does not assure that this product is safe, effective,||
4333|004|Z|or appropriate for you. This information is not individual||
4333|005|Z|medical advice and does not substitute for the advice of your||
4333|006|Z|health care professional. Always ask your health care||
4333|007|Z|professional for complete information about this product and your||
4333|008|Z|specific health needs.||
4333|009|B|||
4333|010|T|FLUTICASONE DISK INHALER - ORAL INHALATION||
4333|011|F|(floo-TIK-a-sone)||
4333|012|B|||
4333|013|C|COMMON BRAND NAME(S): Flovent Rotadisk||
4333|014|B|||
4333|015|U|USES:  Fluticasone is used to control and prevent symptoms (such||
4333|016|U|as wheezing and shortness of breath) caused by asthma. It works||
4333|017|U|by reducing swelling (inflammation) of the airways in the lungs||
4333|018|U|to make breathing easier. Controlling symptoms of asthma helps||
4333|019|U|you maintain your normal activities and decreases time lost from||
4333|020|U|work or school. Fluticasone belongs to a class of drugs known as||
4333|021|U|corticosteroids.||
4333|022|U|   This medication must be used regularly to be effective. It||
4333|023|U|does not work right away and should not be used to relieve sudden||
4333|024|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
4333|025|U|inhaler (such as albuterol, also called salbutamol in some||
4333|026|U|countries) as prescribed.||
4333|027|B|||
4333|028|V|OTHER USES:  This section contains uses of this drug that are not||
4333|029|V|listed in the approved professional labeling for the drug but||
4333|030|V|that may be prescribed by your health care professional. Use this||
4333|031|V|drug for a condition that is listed in this section only if it||
4333|032|V|has been so prescribed by your health care professional.||
4333|033|V|   Fluticasone may also be used with other medications to control||
4333|034|V|symptoms of ongoing lung disease (such as chronic bronchitis,||
4333|035|V|emphysema, COPD). It may also be used for a certain esophagus||
4333|036|V|problem (eosinophilic esophagitis).||
4333|037|B|||
4333|038|H|HOW TO USE:  Read the Patient Information Leaflet and||
4333|039|H|Instructions for Use provided by your pharmacist before you start||
4333|040|H|using this medication and each time you get a refill. Follow the||
4333|041|H|illustrated directions for the proper use of this medication. If||
4333|042|H|you have any questions, ask your doctor or pharmacist.||
4333|043|H|   Hold this device in a level, flat position. Inhale this||
4333|044|H|medication by mouth as directed by your doctor, usually twice a||
4333|045|H|day (in the morning and evening). The dosage is based on your||
4333|046|H|medical condition and response to treatment.||
4333|047|H|   It is important to inhale each dose deeply to get the right||
4333|048|H|amount of drug into your lungs. You may or may not taste/feel the||
4333|049|H|drug when you inhale. Either is normal. Do not breathe out||
4333|050|H|(exhale) into the inhaler device.||
4333|051|H|   If two inhalations are prescribed, wait at least one minute||
4333|052|H|between them. If you are using other inhalers at the same time,||
4333|053|H|wait at least 1 minute between the use of each medication, and||
4333|054|H|use this drug (the corticosteroid) last.||
4333|055|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
4333|056|H|from developing, gargle, rinse your mouth with water and spit out||
4333|057|H|after each use. Do not swallow the rinse water.||
4333|058|H|   Do not take the inhaler apart or wash the mouthpiece or any||
4333|059|H|part of the device. Close the device after each use.||
4333|060|H|   Use this medication regularly to get the most benefit from it.||
4333|061|H|This medication works best if used at evenly spaced intervals. To||
4333|062|H|help you remember, use it at the same times each day. Do not||
4333|063|H|increase your dose, use this medication more often, or stop using||
4333|064|H|it without first consulting your doctor.||
4333|065|H|   If you are regularly taking a different corticosteroid by||
4333|066|H|mouth (such as prednisone), you should not stop taking it unless||
4333|067|H|directed by your doctor. Some conditions (such as asthma,||
4333|068|H|allergies) may become worse when the drug is suddenly stopped. If||
4333|069|H|you suddenly stop taking the drug, you may also have withdrawal||
4333|070|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
4333|071|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
4333|072|H|doctor may slowly lower the dose of your old medication after you||
4333|073|H|begin using fluticasone. Tell your doctor or pharmacist right||
4333|074|H|away if you have withdrawal. See also Precautions section.||
4333|075|H|   It may take up to 2 weeks or longer before the full benefit of||
4333|076|H|this drug takes effect. Tell your doctor if your condition does||
4333|077|H|not get better or if it gets worse.||
4333|078|H|   Learn which of your inhalers you should use every day||
4333|079|H|(controller drugs) and which you should use if your breathing||
4333|080|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
4333|081|H|time what you should do if you have new or worsening cough or||
4333|082|H|shortness of breath, wheezing, increased sputum, worsening peak||
4333|083|H|flow meter readings, waking up at night with trouble breathing,||
4333|084|H|if you use your quick-relief inhaler more often (more than 2 days||
4333|085|H|a week), or if your quick-relief inhaler does not seem to be||
4333|086|H|working well. Learn when you can treat sudden breathing problems||
4333|087|H|by yourself and when you must get medical help right away.||
4333|088|B|||
4333|089|S|SIDE EFFECTS:  Hoarseness, throat irritation, or headache may||
4333|090|S|occur. If any of these effects last or get worse, tell your||
4333|091|S|doctor or pharmacist promptly.||
4333|092|S|   Remember that this medication has been prescribed because your||
4333|093|S|doctor has judged that the benefit to you is greater than the||
4333|094|S|risk of side effects. Many people using this medication do not||
4333|095|S|have serious side effects.||
4333|096|S|   Tell your doctor right away if you have any serious side||
4333|097|S|effects, including: white patches in your mouth/on your tongue,||
4333|098|S|signs of infection (such as sore throat that doesn't go away,||
4333|099|S|fever, chills), vision problems, increased thirst/urination, easy||
4333|100|S|bruising/bleeding, mental/mood changes (such as depression, mood||
4333|101|S|swings, agitation), bone pain.||
4333|102|S|   Rarely, this medication may cause sudden severe||
4333|103|S|wheezing/trouble breathing immediately after you use it. If this||
4333|104|S|occurs, use your quick-relief inhaler and get medical help right||
4333|105|S|away.||
4333|106|S|   A very serious allergic reaction to this drug is rare.||
4333|107|S|However, get medical help right away if you notice any symptoms||
4333|108|S|of a serious allergic reaction, including: rash, itching/swelling||
4333|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4333|110|S|breathing.||
4333|111|S|   This is not a complete list of possible side effects. If you||
4333|112|S|notice other effects not listed above, contact your doctor or||
4333|113|S|pharmacist.||
4333|114|S|   In the US -||
4333|115|S|   Call your doctor for medical advice about side effects. You||
4333|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4333|117|S|www.fda.gov/medwatch.||
4333|118|S|   In Canada - Call your doctor for medical advice about side||
4333|119|S|effects. You may report side effects to Health Canada at||
4333|120|S|1-866-234-2345.||
4333|121|B|||
4333|122|P|PRECAUTIONS:  Before using fluticasone, tell your doctor or||
4333|123|P|pharmacist if you are allergic to it; or if you have any other||
4333|124|P|allergies. This product may contain inactive ingredients (such as||
4333|125|P|lactose, milk proteins), which can cause allergic reactions or||
4333|126|P|other problems. Talk to your pharmacist for more details.||
4333|127|P|   Before using this medication, tell your doctor or pharmacist||
4333|128|P|your medical history, especially of: current/past infections||
4333|129|P|(such as tuberculosis, herpes), certain eye problems (cataracts,||
4333|130|P|glaucoma, herpes infection of the eye), bone loss (osteoporosis),||
4333|131|P|liver disease.||
4333|132|P|   This medication may mask signs of infection. It can make you||
4333|133|P|more likely to get infections or may make current infections||
4333|134|P|worse. Stay away from anyone who has an infection that may easily||
4333|135|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
4333|136|P|doctor if you have been exposed to an infection or for more||
4333|137|P|details.||
4333|138|P|   If you have switched from a corticosteroid taken by mouth||
4333|139|P|(such as prednisone tablets) to this inhaler within the past 12||
4333|140|P|months, or if you have been using this product in||
4333|141|P|higher-than-usual doses for a long time, it may be more difficult||
4333|142|P|for your body to respond to physical stress. Before having||
4333|143|P|surgery or emergency treatment, or if you get a serious||
4333|144|P|illness/injury, tell your doctor or dentist that you are using||
4333|145|P|this medication or have used a corticosteroid taken by mouth||
4333|146|P|within the past 12 months. Tell your doctor right away if you||
4333|147|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
4333|148|P|card or medical ID bracelet that says you use (or have used)||
4333|149|P|corticosteroid medications.||
4333|150|P|   Before having surgery, tell your doctor or dentist about all||
4333|151|P|the products you use (including prescription drugs,||
4333|152|P|nonprescription drugs, and herbal products).||
4333|153|P|   This medication may temporarily slow down a child's growth if||
4333|154|P|used for a long time. However, poorly controlled asthma can also||
4333|155|P|slow down growth. See the doctor regularly so your child's height||
4333|156|P|can be checked.||
4333|157|P|   During pregnancy, this medication should be used only when||
4333|158|P|clearly needed. Discuss the risks and benefits with your doctor.||
4333|159|P|   It is unknown if this drug passes into breast milk. Consult||
4333|160|P|your doctor before breastfeeding.||
4333|161|B|||
4333|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4333|163|I|medications work or increase your risk for serious side effects.||
4333|164|I|This document does not contain all possible drug interactions.||
4333|165|I|Keep a list of all the products you use (including||
4333|166|I|prescription/nonprescription drugs and herbal products) and share||
4333|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
4333|168|I|the dosage of any medicines without your doctor's approval.||
4333|169|I|   A product that may interact with this drug is: desmopressin.||
4333|170|I|   Other medications can affect the removal of fluticasone from||
4333|171|I|your body, which may affect how fluticasone works. Examples||
4333|172|I|include some azole antifungals (such as ketoconazole), HIV||
4333|173|I|protease inhibitors (such as lopinavir), ritonavir, among others.||
4333|174|B|||
4333|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4333|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4333|177|O|poison control center right away. US residents can call||
4333|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4333|179|B|||
4333|180|N|NOTES:  Do not share this medication with others.||
4333|181|N|   Lab and/or medical tests (such as lung function, eye exams,||
4333|182|N|bone density tests, cortisol levels) should be done while you are||
4333|183|N|using this medication. Keep all medical and lab appointments.||
4333|184|N|Consult your doctor for more details.||
4333|185|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
4333|186|N|mold that can worsen breathing problems. Because the flu virus||
4333|187|N|can also worsen breathing problems, ask your doctor or pharmacist||
4333|188|N|if you should have a flu shot every year.||
4333|189|N|   This medication may cause bone loss (osteoporosis) in adults||
4333|190|N|when used for a long time. Lifestyle changes that may help reduce||
4333|191|N|the risk of bone problems include doing weight-bearing exercise,||
4333|192|N|stopping smoking, limiting alcohol, and getting enough calcium||
4333|193|N|and vitamin D. Talk to your doctor for more details.||
4333|194|B|||
4333|195|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4333|196|D|If it is near the time of the next dose, skip the missed dose.||
4333|197|D|Use your next dose at the regular time. Do not double the dose to||
4333|198|D|catch up.||
4333|199|B|||
4333|200|R|STORAGE:  Different brands of this medication have different||
4333|201|R|storage needs. Check the product package for instructions on how||
4333|202|R|to store your brand, or ask your pharmacist. Keep all medications||
4333|203|R|away from children and pets.||
4333|204|R|   Do not flush medications down the toilet or pour them into a||
4333|205|R|drain unless instructed to do so. Properly discard this product||
4333|206|R|when it is expired or no longer needed. Consult your pharmacist||
4333|207|R|or local waste disposal company.||
4333|208|B|||
4333|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
4333|210|M|medical emergency. For information about enrolling in MedicAlert,||
4333|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4333|212|B|||
4333|213|A|Information last revised September 2025.||
4333|214|A|Copyright(c) 2025 First Databank, Inc.||
4333|215|B|||
4341|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4341|002|Z|does NOT have all possible information about this product. This||
4341|003|Z|information does not assure that this product is safe, effective,||
4341|004|Z|or appropriate for you. This information is not individual||
4341|005|Z|medical advice and does not substitute for the advice of your||
4341|006|Z|health care professional. Always ask your health care||
4341|007|Z|professional for complete information about this product and your||
4341|008|Z|specific health needs.||
4341|009|B|||
4341|010|T|LEUPROLIDE MONTHLY (7.5 MG) - SUBCUTANEOUS INJECTION||
4341|011|F|(LOO-proe-lide)||
4341|012|B|||
4341|013|C|COMMON BRAND NAME(S): Eligard||
4341|014|B|||
4341|015|U|USES:  Leuprolide is used to treat advanced prostate cancer. It||
4341|016|U|is not a cure. Most types of prostate cancer need the hormone||
4341|017|U|testosterone to grow and spread. Leuprolide works by reducing the||
4341|018|U|amount of testosterone that the body makes. This helps slow or||
4341|019|U|stop the growth of cancer cells and helps relieve symptoms such||
4341|020|U|as painful/difficult urination. Talk to your doctor about the||
4341|021|U|risks and benefits of treatment.||
4341|022|B|||
4341|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4341|024|H|from your pharmacist before you start using leuprolide and each||
4341|025|H|time you get a refill. If you have any questions, ask your doctor||
4341|026|H|or pharmacist.||
4341|027|H|   This medication is given by injection under the skin by a||
4341|028|H|healthcare professional as directed by your doctor, usually once||
4341|029|H|a month. This product slowly releases the medication into your||
4341|030|H|blood over a 1-month period.||
4341|031|H|   Use this medication regularly to get the most benefit from it.||
4341|032|H|To help you remember, mark your calendar with a reminder.||
4341|033|H|   During the first few weeks of treatment, your hormone levels||
4341|034|H|will actually go up before they go down. This is a normal||
4341|035|H|response to this medication. Your symptoms may get worse for a||
4341|036|H|few weeks. If you have prostate cancer that has spread to the||
4341|037|H|spine or caused urinary blockage, you may require closer||
4341|038|H|monitoring by your doctor, especially when you first start||
4341|039|H|treatment. Tell your doctor right away if you have any bone pain,||
4341|040|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
4341|041|H|painful/difficult urination, unusual weakness, or inability to||
4341|042|H|move.||
4341|043|B|||
4341|044|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
4341|045|S|sweats, tiredness, swelling of the ankles/feet, increased||
4341|046|S|urination at night, dizziness, or mild burning/pain/bruising at||
4341|047|S|the injection site may occur. If any of these effects last or get||
4341|048|S|worse, tell your doctor or pharmacist promptly.||
4341|049|S|   Rarely, shrinking of the testicles, breast||
4341|050|S|tenderness/swelling, or reduced sexual interest/ability may also||
4341|051|S|occur as a result of lowered testosterone levels. Talk to your||
4341|052|S|doctor if these effects occur.||
4341|053|S|   Remember that this medication has been prescribed because your||
4341|054|S|doctor has judged that the benefit to you is greater than the||
4341|055|S|risk of side effects. Many people using this medication do not||
4341|056|S|have serious side effects.||
4341|057|S|   Tell your doctor right away if you have any serious side||
4341|058|S|effects, including: new/worsening bone pain, easily broken bones,||
4341|059|S|increased thirst/urination, mental/mood changes (such as||
4341|060|S|depression, thoughts of suicide, mood swings, aggression), signs||
4341|061|S|of liver disease (such as nausea/vomiting that doesn't stop, loss||
4341|062|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
4341|063|S|urine).||
4341|064|S|   Get medical help right away if you have any very serious side||
4341|065|S|effects, including: symptoms of a heart attack (such as||
4341|066|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
4341|067|S|signs of a stroke (such as weakness on one side of the body,||
4341|068|S|trouble speaking, sudden vision changes, confusion), seizures,||
4341|069|S|fast/irregular heartbeat, severe dizziness, fainting.||
4341|070|S|   A very serious allergic reaction to this drug is rare.||
4341|071|S|However, get medical help right away if you notice any symptoms||
4341|072|S|of a serious allergic reaction, including: fever, swollen lymph||
4341|073|S|nodes, rash, itching/swelling (especially of the||
4341|074|S|face/tongue/throat), severe dizziness, trouble breathing.||
4341|075|S|   This is not a complete list of possible side effects. If you||
4341|076|S|notice other effects not listed above, contact your doctor or||
4341|077|S|pharmacist.||
4341|078|S|   In the US -||
4341|079|S|   Call your doctor for medical advice about side effects. You||
4341|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4341|081|S|www.fda.gov/medwatch.||
4341|082|S|   In Canada - Call your doctor for medical advice about side||
4341|083|S|effects. You may report side effects to Health Canada at||
4341|084|S|1-866-234-2345.||
4341|085|B|||
4341|086|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
4341|087|P|pharmacist if you are allergic to it; or to similar drugs (such||
4341|088|P|as histrelin, triptorelin); or if you have any other allergies.||
4341|089|P|This product may contain inactive ingredients, which can cause||
4341|090|P|allergic reactions or other problems. Talk to your pharmacist for||
4341|091|P|more details.||
4341|092|P|   Before using this medication, tell your doctor or pharmacist||
4341|093|P|your medical history, especially of: diabetes, heart disease||
4341|094|P|(such as heart attack), stroke, high cholesterol, mental/mood||
4341|095|P|problems (such as depression), seizures.||
4341|096|P|   Leuprolide may weaken your bones and increase your risk for||
4341|097|P|bone loss (osteoporosis) if used for a long time. Before using||
4341|098|P|this medication, tell your doctor or pharmacist if you have||
4341|099|P|osteoporosis or if you have any of the following risk factors for||
4341|100|P|osteoporosis: long-term alcohol use, smoking, family history of||
4341|101|P|osteoporosis and broken bones, use of certain medications (for||
4341|102|P|example, corticosteroids such as prednisone, certain anti-seizure||
4341|103|P|drugs such as phenytoin).||
4341|104|P|   Leuprolide may cause a condition that affects the heart rhythm||
4341|105|P|(QT prolongation). QT prolongation can rarely cause serious||
4341|106|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
4341|107|P|as severe dizziness, fainting) that need medical attention right||
4341|108|P|away.||
4341|109|P|   The risk of QT prolongation may be increased if you have||
4341|110|P|certain medical conditions or are taking other drugs that may||
4341|111|P|cause QT prolongation. Before using leuprolide, tell your doctor||
4341|112|P|or pharmacist of all the drugs you take and if you have any of||
4341|113|P|the following conditions: certain heart problems (heart failure,||
4341|114|P|slow heartbeat, QT prolongation in the EKG), family history of||
4341|115|P|certain heart problems (QT prolongation in the EKG, sudden||
4341|116|P|cardiac death).||
4341|117|P|   Low levels of potassium or magnesium in the blood may also||
4341|118|P|increase your risk of QT prolongation. This risk may increase if||
4341|119|P|you use certain drugs (such as diuretics/"water pills") or if you||
4341|120|P|have conditions such as severe sweating, diarrhea, or vomiting.||
4341|121|P|Talk to your doctor about using leuprolide safely.||
4341|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4341|123|P|can make you more dizzy. Do not drive, use machinery, or do||
4341|124|P|anything that needs alertness until you can do it safely. Limit||
4341|125|P|alcoholic beverages. Talk to your doctor if you are using||
4341|126|P|marijuana (cannabis).||
4341|127|P|   Before having surgery, tell your doctor or dentist about all||
4341|128|P|the products you use (including prescription drugs,||
4341|129|P|nonprescription drugs, and herbal products).||
4341|130|P|   Older adults may be more sensitive to the side effects of this||
4341|131|P|drug, especially QT prolongation (see above).||
4341|132|P|   This medication can affect fertility in males. Ask your doctor||
4341|133|P|for more details.||
4341|134|P|   This medication must not be used during pregnancy. It may harm||
4341|135|P|an unborn baby. It is important to prevent pregnancy while using||
4341|136|P|this medication. Consult your doctor for more details and to||
4341|137|P|discuss using reliable forms of non-hormonal birth control (such||
4341|138|P|as condoms, diaphragm with spermicide) while using this||
4341|139|P|medication. If you become pregnant or think you may be pregnant,||
4341|140|P|tell your doctor right away.||
4341|141|P|   It is unknown if leuprolide passes into breast milk. Because||
4341|142|P|of the possible risk to the infant, breastfeeding is not||
4341|143|P|recommended while using this medication. Consult your doctor||
4341|144|P|before breastfeeding.||
4341|145|B|||
4341|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4341|147|I|medications work or increase your risk for serious side effects.||
4341|148|I|This document does not contain all possible drug interactions.||
4341|149|I|Keep a list of all the products you use (including||
4341|150|I|prescription/nonprescription drugs and herbal products) and share||
4341|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
4341|152|I|the dosage of any medicines without your doctor's approval.||
4341|153|I|   This medication may interfere with certain lab tests, possibly||
4341|154|I|causing false test results. Make sure lab personnel and all your||
4341|155|I|doctors know you use this drug.||
4341|156|B|||
4341|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4341|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4341|159|O|poison control center right away. US residents can call||
4341|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4341|161|B|||
4341|162|N|NOTES:  Do not share this medication with others.||
4341|163|N|   Lab and/or medical tests (such as blood testosterone level,||
4341|164|N|PSA blood test, blood glucose, cholesterol/triglyceride levels)||
4341|165|N|should be done while you are using this medication. Keep all||
4341|166|N|medical and lab appointments. Consult your doctor for more||
4341|167|N|details.||
4341|168|B|||
4341|169|D|MISSED DOSE:  It is important to get each dose of this medication||
4341|170|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
4341|171|D|right away for a new dosing schedule. Do not double the dose to||
4341|172|D|catch up.||
4341|173|B|||
4341|174|R|STORAGE:  Not applicable. This medication is given in a clinic or||
4341|175|R|doctor's office and will not be stored at home.||
4341|176|B|||
4341|177|A|Information last revised October 2024.||
4341|178|A|Copyright(c) 2025 First Databank, Inc.||
4341|179|B|||
4343|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4343|002|Z|does NOT have all possible information about this product. This||
4343|003|Z|information does not assure that this product is safe, effective,||
4343|004|Z|or appropriate for you. This information is not individual||
4343|005|Z|medical advice and does not substitute for the advice of your||
4343|006|Z|health care professional. Always ask your health care||
4343|007|Z|professional for complete information about this product and your||
4343|008|Z|specific health needs.||
4343|009|B|||
4343|010|T|HEME IRON POLYPEPTIDE/FOLIC ACID - ORAL||
4343|011|F|(heem iron poly-PEP-tide/FOE-lick)||
4343|012|B|||
4343|013|C|COMMON BRAND NAME(S): Proferrin-Forte||
4343|014|B|||
4343|015|W|WARNING:  Accidental overdose of iron-containing products is a||
4343|016|W|leading cause of fatal poisoning in children younger than 6||
4343|017|W|years. Keep this product out of reach of children. If overdose||
4343|018|W|does occur, get medical help right away or call a poison control||
4343|019|W|center.||
4343|020|B|||
4343|021|U|USES:  Heme iron polypeptide is a form of iron supplement. It is||
4343|022|U|used to treat or prevent iron deficiency anemia (low red blood||
4343|023|U|cell count). Certain medical conditions may increase the risk of||
4343|024|U|iron deficiency (such as pregnancy, certain types of surgery,||
4343|025|U|chemotherapy, kidney failure).||
4343|026|U|   This medication is typically used in people who cannot absorb||
4343|027|U|or tolerate regular iron products (such as ferrous sulfate).||
4343|028|U|   Folic acid is a B-vitamin used to treat certain anemias due to||
4343|029|U|poor diet, pregnancy, and other conditions.||
4343|030|B|||
4343|031|H|HOW TO USE:  Take this medication by mouth usually once or twice||
4343|032|H|daily with or without meals; or as directed by your doctor. Take||
4343|033|H|this medication with a full glass (8 ounces or 240 milliliters)||
4343|034|H|of water, unless otherwise directed by your doctor. Do not lie||
4343|035|H|down for at least 10 minutes after taking this medication.||
4343|036|H|   The dosage depends on your medical condition and response to||
4343|037|H|treatment.||
4343|038|B|||
4343|039|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
4343|040|S|because your doctor has judged that the benefit to you is greater||
4343|041|S|than the risk of side effects. Many people using this medication||
4343|042|S|do not have serious side effects.||
4343|043|S|   A very serious allergic reaction to this product is rare.||
4343|044|S|However, get medical help right away if you notice any symptoms||
4343|045|S|of a serious allergic reaction, including: rash, itching/swelling||
4343|046|S|(especially of the face/tongue/throat), dizziness, trouble||
4343|047|S|breathing.||
4343|048|S|   This is not a complete list of possible side effects. If you||
4343|049|S|notice any unusual effects, contact your doctor or pharmacist.||
4343|050|S|   In the US -||
4343|051|S|   Call your doctor for medical advice about side effects. You||
4343|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4343|053|S|www.fda.gov/medwatch.||
4343|054|S|   In Canada - Call your doctor for medical advice about side||
4343|055|S|effects. You may report side effects to Health Canada at||
4343|056|S|1-866-234-2345.||
4343|057|B|||
4343|058|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
4343|059|P|pharmacist if you are allergic to it; or to meat products; or if||
4343|060|P|you have any other allergies. This product may contain inactive||
4343|061|P|ingredients, which can cause allergic reactions or other||
4343|062|P|problems. Talk to your pharmacist for more details.||
4343|063|P|   Before using this medication, tell your doctor or pharmacist||
4343|064|P|your medical history, especially of: iron metabolism disorders||
4343|065|P|(such as hemochromatosis), other types of anemia (such as||
4343|066|P|pernicious anemia).||
4343|067|P|   This product is made from the red blood cells of cows. If you||
4343|068|P|prefer not to use products made from animal sources, consult your||
4343|069|P|doctor regarding other products that contain iron.||
4343|070|P|   Before having surgery, tell your doctor or dentist about all||
4343|071|P|the products you use (including prescription drugs,||
4343|072|P|nonprescription drugs, and herbal products).||
4343|073|P|   This medication is safe to use during pregnancy when taken as||
4343|074|P|directed by your doctor.||
4343|075|P|   It is unknown if the iron in this product passes into breast||
4343|076|P|milk. Folic acid passes into breast milk. Consult your doctor||
4343|077|P|before breastfeeding.||
4343|078|B|||
4343|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
4343|080|I|medications work or increase your risk for serious side effects.||
4343|081|I|This document does not contain all possible drug interactions.||
4343|082|I|Keep a list of all the products you use (including||
4343|083|I|prescription/nonprescription drugs and herbal products) and share||
4343|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
4343|085|I|the dosage of any medicines without your doctor's approval.||
4343|086|I|   Some drugs that may interact with this product include:||
4343|087|I|antacids.||
4343|088|I|   This product can decrease the absorption of certain drugs,||
4343|089|I|especially if you take them around the same time. These drugs||
4343|090|I|include bisphosphonates (such as alendronate), levodopa,||
4343|091|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
4343|092|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
4343|093|I|minocycline), thyroid medications (such as levothyroxine), among||
4343|094|I|others. Ask your doctor or pharmacist how long you should wait||
4343|095|I|between doses of this product and your other medications and to||
4343|096|I|find a dosing schedule that works for all your medications.||
4343|097|I|   This product may interfere with certain lab tests (such as||
4343|098|I|testing for blood in stools), possibly causing false test||
4343|099|I|results. Make sure lab personnel and all your doctors know you||
4343|100|I|use this product.||
4343|101|B|||
4343|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4343|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4343|104|O|poison control center right away. US residents can call||
4343|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4343|106|O|Symptoms of overdose may include: vomiting, severe stomach upset.||
4343|107|B|||
4343|108|N|NOTES:  Lab and/or medical tests (such as vitamin B12 levels) may||
4343|109|N|be done while you are taking this medication. Keep all medical||
4343|110|N|and lab appointments. Consult your doctor for more details.||
4343|111|N|   Do not share this medication with others.||
4343|112|B|||
4343|113|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
4343|114|D|If it is near the time of the next dose, skip the missed dose.||
4343|115|D|Use your next dose at the regular time. Do not double the dose to||
4343|116|D|catch up.||
4343|117|B|||
4343|118|R|STORAGE:  Store at room temperature away from light and moisture.||
4343|119|R|Do not store in the bathroom. Keep all medications away from||
4343|120|R|children and pets.||
4343|121|R|   Do not flush medications down the toilet or pour them into a||
4343|122|R|drain unless instructed to do so. Properly discard this product||
4343|123|R|when it is expired or no longer needed. Consult your pharmacist||
4343|124|R|or local waste disposal company.||
4343|125|B|||
4343|126|A|Information last revised October 2025.||
4343|127|A|Copyright(c) 2025 First Databank, Inc.||
4343|128|B|||
4352|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4352|002|Z|does NOT have all possible information about this product. This||
4352|003|Z|information does not assure that this product is safe, effective,||
4352|004|Z|or appropriate for you. This information is not individual||
4352|005|Z|medical advice and does not substitute for the advice of your||
4352|006|Z|health care professional. Always ask your health care||
4352|007|Z|professional for complete information about this product and your||
4352|008|Z|specific health needs.||
4352|009|B|||
4352|010|T|HYDROCODONE/ACETAMINOPHEN - ORAL||
4352|011|F|(HYE-droe-KOE-done/a-SEET-a-MIN-oh-fen)||
4352|012|B|||
4352|013|C|COMMON BRAND NAME(S): Lortab, Norco, Vicodin||
4352|014|B|||
4352|015|W|WARNING:  Hydrocodone/acetaminophen has a risk for abuse and||
4352|016|W|addiction, which can lead to overdose and death.||
4352|017|W|Hydrocodone/acetaminophen may also cause severe, possibly fatal,||
4352|018|W|breathing problems. To lower your risk, your doctor should have||
4352|019|W|you take the smallest dose of hydrocodone/acetaminophen that||
4352|020|W|works, and take it for the shortest possible time. See also How||
4352|021|W|to Use section for more information about addiction.||
4352|022|W|   Ask your doctor or pharmacist if you should have medication||
4352|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
4352|024|W|Teach your family or household members about the signs of an||
4352|025|W|opioid overdose and how to treat it.||
4352|026|W|   The risk for severe breathing problems is higher when you||
4352|027|W|start this medication and after a dose increase, or if you take||
4352|028|W|the wrong dose/strength. Taking this medication with alcohol or||
4352|029|W|other drugs that can cause drowsiness or breathing problems may||
4352|030|W|cause very serious side effects, including death. Also, other||
4352|031|W|medications can affect the removal of hydrocodone/acetaminophen||
4352|032|W|from your body, which may affect how it works. Be sure you know||
4352|033|W|how to take hydrocodone/acetaminophen and what other drugs you||
4352|034|W|should avoid taking with it. See also Drug Interactions section.||
4352|035|W|Get medical help right away if any of these very serious side||
4352|036|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
4352|037|W|severe drowsiness/dizziness, difficulty waking up.||
4352|038|W|   Keep this medicine in a safe place to prevent theft, misuse,||
4352|039|W|or abuse. If someone accidentally swallows this drug, get medical||
4352|040|W|help right away.||
4352|041|W|   One ingredient in this product is acetaminophen. Taking too||
4352|042|W|much acetaminophen may cause serious (possibly fatal) liver||
4352|043|W|disease. Adults should not take more than 4000 milligrams (4||
4352|044|W|grams) of acetaminophen a day. People with liver problems and||
4352|045|W|children should take less acetaminophen. Ask your doctor or||
4352|046|W|pharmacist how much acetaminophen is safe to take.||
4352|047|W|   Do not use with any other drug containing acetaminophen||
4352|048|W|without asking your doctor or pharmacist first. Acetaminophen is||
4352|049|W|in many nonprescription and prescription medications (such as||
4352|050|W|pain/fever drugs or cough-and-cold products). Check the labels on||
4352|051|W|all your medicines to see if they contain acetaminophen, and ask||
4352|052|W|your pharmacist if you are unsure.||
4352|053|W|   Get medical help right away if you take too much acetaminophen||
4352|054|W|(overdose), even if you feel well. Overdose symptoms may include||
4352|055|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
4352|056|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
4352|057|W|   Daily alcohol use, especially when combined with||
4352|058|W|acetaminophen, may damage your liver. Avoid alcohol.||
4352|059|W|   Before using this medication, women of childbearing age should||
4352|060|W|talk with their doctor(s) about the risks and benefits. Tell your||
4352|061|W|doctor if you are pregnant or if you plan to become pregnant.||
4352|062|W|During pregnancy, this medication should be used only when||
4352|063|W|clearly needed. It may slightly increase the risk of birth||
4352|064|W|defects if used during the first two months of pregnancy. Also,||
4352|065|W|using it for a long time or in high doses near the expected||
4352|066|W|delivery date may harm the unborn baby. To lessen the risk, take||
4352|067|W|the smallest effective dose for the shortest possible time.||
4352|068|W|Babies born to mothers who use this drug for a long time may||
4352|069|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
4352|070|W|doctor right away if you notice any symptoms in your newborn baby||
4352|071|W|such as crying that doesn't stop, slow/shallow breathing,||
4352|072|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
4352|073|W|difficulty gaining weight.||
4352|074|B|||
4352|075|U|USES:  This combination medication is used to relieve moderate to||
4352|076|U|severe pain. It contains an opioid pain reliever (hydrocodone)||
4352|077|U|and a non-opioid pain reliever (acetaminophen). Hydrocodone works||
4352|078|U|in the brain to change how your body feels and responds to pain.||
4352|079|U|Acetaminophen can also reduce a fever.||
4352|080|B|||
4352|081|H|HOW TO USE:  See also Warning section.||
4352|082|H|   Read the Medication Guide and, if available, the Patient||
4352|083|H|Information Leaflet provided by your pharmacist before you start||
4352|084|H|taking this medication and each time you get a refill. If you||
4352|085|H|have any questions, ask your doctor or pharmacist.||
4352|086|H|   Take this medication by mouth as directed by your doctor. You||
4352|087|H|may take this drug with or without food. If you have nausea, it||
4352|088|H|may help to take this drug with food. Ask your doctor or||
4352|089|H|pharmacist about other ways to decrease nausea (such as lying||
4352|090|H|down for 1 to 2 hours with as little head movement as possible).||
4352|091|H|   If you are using a liquid form of this medication, use a||
4352|092|H|medication measuring device to carefully measure the prescribed||
4352|093|H|dose. Do not use a household spoon because you may not get the||
4352|094|H|correct dose.||
4352|095|H|   The dosage is based on your medical condition and response to||
4352|096|H|treatment. Children's dosage is also based on weight. Do not||
4352|097|H|increase your dose, take the medication more often, or take it||
4352|098|H|for a longer time than prescribed. Properly stop the medication||
4352|099|H|when so directed.||
4352|100|H|   Pain medications work best if they are used as the first signs||
4352|101|H|of pain occur. If you wait until the pain has worsened, the||
4352|102|H|medication may not work as well.||
4352|103|H|   If you have ongoing pain (such as due to cancer), your doctor||
4352|104|H|may direct you to also take long-acting opioid medications. In||
4352|105|H|that case, this medication might be used for sudden||
4352|106|H|(breakthrough) pain only as needed. Other pain relievers (such as||
4352|107|H|ibuprofen, naproxen) may also be prescribed. Ask your doctor or||
4352|108|H|pharmacist about using this product safely with other drugs.||
4352|109|H|   Suddenly stopping this medication may cause withdrawal,||
4352|110|H|especially if you have used it for a long time or in high doses.||
4352|111|H|To prevent withdrawal, your doctor may lower your dose slowly.||
4352|112|H|Tell your doctor or pharmacist right away if you have any||
4352|113|H|withdrawal symptoms such as restlessness, mental/mood changes||
4352|114|H|(including anxiety, trouble sleeping, thoughts of suicide),||
4352|115|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
4352|116|H|aches, or sudden changes in behavior.||
4352|117|H|   When this medication is used for a long time, it may not work||
4352|118|H|as well. Talk with your doctor if this medication stops working||
4352|119|H|well.||
4352|120|H|   Though it helps many people, this medication may sometimes||
4352|121|H|cause addiction. This risk may be higher if you have a||
4352|122|H|mental/mood disorder or a substance use disorder (such as overuse||
4352|123|H|of or addiction to drugs/alcohol). Take this medication exactly||
4352|124|H|as prescribed to lower the risk of addiction. Ask your doctor or||
4352|125|H|pharmacist for more details.||
4352|126|H|   Tell your doctor if your pain does not get better or if it||
4352|127|H|gets worse, or if you have any new pain.||
4352|128|B|||
4352|129|S|SIDE EFFECTS:  See also Warning section.||
4352|130|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
4352|131|S|drowsiness may occur. Some of these side effects may decrease||
4352|132|S|after you have been using this medication for a while. If any of||
4352|133|S|these effects last or get worse, tell your doctor or pharmacist||
4352|134|S|promptly.||
4352|135|S|   To prevent constipation, eat dietary fiber, drink enough||
4352|136|S|water, and exercise. You may also need to take a laxative. Ask||
4352|137|S|your pharmacist which type of laxative is right for you.||
4352|138|S|   To reduce the risk of dizziness and lightheadedness, get up||
4352|139|S|slowly when rising from a sitting or lying position.||
4352|140|S|   Remember that this medication has been prescribed because your||
4352|141|S|doctor has judged that the benefit to you is greater than the||
4352|142|S|risk of side effects. Many people using this medication do not||
4352|143|S|have serious side effects.||
4352|144|S|   Tell your doctor right away if you have any serious side||
4352|145|S|effects, including: interrupted breathing during sleep (sleep||
4352|146|S|apnea), mental/mood changes (such as agitation, confusion,||
4352|147|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
4352|148|S|signs of your adrenal glands not working well (such as loss of||
4352|149|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
4352|150|S|   Get medical help right away if you have any very serious side||
4352|151|S|effects, including: fainting, seizure, slow/shallow breathing,||
4352|152|S|severe drowsiness/difficulty waking up.||
4352|153|S|   A very serious allergic reaction to this drug is rare.||
4352|154|S|However, get medical help right away if you notice any symptoms||
4352|155|S|of a serious allergic reaction, including: rash, itching/swelling||
4352|156|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4352|157|S|breathing.||
4352|158|S|   This is not a complete list of possible side effects. If you||
4352|159|S|notice other effects not listed above, contact your doctor or||
4352|160|S|pharmacist.||
4352|161|S|   In the US -||
4352|162|S|   Call your doctor for medical advice about side effects. You||
4352|163|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4352|164|S|www.fda.gov/medwatch.||
4352|165|S|   In Canada - Call your doctor for medical advice about side||
4352|166|S|effects. You may report side effects to Health Canada at||
4352|167|S|1-866-234-2345.||
4352|168|B|||
4352|169|P|PRECAUTIONS:  See also Warning section.||
4352|170|P|   Before taking this medication, tell your doctor or pharmacist||
4352|171|P|if you are allergic to it; or to other opioids (such as||
4352|172|P|benzhydrocodone, hydromorphone, morphine, codeine); or if you||
4352|173|P|have any other allergies. This product may contain inactive||
4352|174|P|ingredients, which can cause allergic reactions or other||
4352|175|P|problems. Talk to your pharmacist for more details.||
4352|176|P|   Before using this medication, tell your doctor or pharmacist||
4352|177|P|your medical history, especially of: brain disorders (such as||
4352|178|P|head injury, tumor, seizures), breathing problems (such as||
4352|179|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
4352|180|P|kidney disease, liver disease, mental/mood disorders (such as||
4352|181|P|confusion, depression, thoughts of suicide), personal or family||
4352|182|P|history of a substance use disorder (such as overuse of or||
4352|183|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
4352|184|P|blockage, constipation, diarrhea due to infection, paralytic||
4352|185|P|ileus), difficulty urinating (such as due to enlarged prostate),||
4352|186|P|gallbladder disease, disease of the pancreas (pancreatitis).||
4352|187|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
4352|188|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
4352|189|P|machinery, or do anything that needs alertness until you can do||
4352|190|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
4352|191|P|are using marijuana (cannabis).||
4352|192|P|   Liquid products may contain sugar and alcohol. Caution is||
4352|193|P|advised if you have diabetes, alcohol dependence, liver disease,||
4352|194|P|or any other condition that requires you to limit/avoid these||
4352|195|P|substances in your diet. Ask your doctor or pharmacist about||
4352|196|P|using this product safely.||
4352|197|P|   Before having surgery, tell your doctor or dentist about all||
4352|198|P|the products you use (including prescription drugs,||
4352|199|P|nonprescription drugs, and herbal products).||
4352|200|P|   Children may be more sensitive to the side effects of this||
4352|201|P|drug, especially slow/shallow breathing.||
4352|202|P|   Older adults may be more sensitive to the side effects of this||
4352|203|P|drug, especially confusion, dizziness, drowsiness, and||
4352|204|P|slow/shallow breathing.||
4352|205|P|   During pregnancy, this medication should be used only when||
4352|206|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
4352|207|P|benefits with your doctor.||
4352|208|P|   This medication passes into breast milk and may have||
4352|209|P|undesirable effects on a nursing infant. Tell the doctor right||
4352|210|P|away if your baby develops unusual sleepiness, difficulty||
4352|211|P|feeding, or trouble breathing. Consult your doctor before||
4352|212|P|breastfeeding.||
4352|213|B|||
4352|214|I|DRUG INTERACTIONS:  See also Warning section.||
4352|215|I|   Drug interactions may change how your medications work or||
4352|216|I|increase your risk for serious side effects. This document does||
4352|217|I|not contain all possible drug interactions. Keep a list of all||
4352|218|I|the products you use (including prescription/nonprescription||
4352|219|I|drugs and herbal products) and share it with your doctor and||
4352|220|I|pharmacist. Do not start, stop, or change the dosage of any||
4352|221|I|medicines without your doctor's approval.||
4352|222|I|   Some products that may interact with this drug are: certain||
4352|223|I|pain medications (mixed opioid agonist/antagonists such as||
4352|224|I|butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.||
4352|225|I|   The risk of serious side effects (such as slow/shallow||
4352|226|I|breathing, severe drowsiness/dizziness) may be increased if this||
4352|227|I|medication is taken with other products that may also cause||
4352|228|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
4352|229|I|if you are taking other products such as other opioid pain or||
4352|230|I|cough relievers (such as codeine, oxycodone), alcohol, marijuana||
4352|231|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
4352|232|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4352|233|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
4352|234|I|diphenhydramine).||
4352|235|I|   Check the labels on all your medicines (such as allergy or||
4352|236|I|cough-and-cold products) because they may contain ingredients||
4352|237|I|that cause drowsiness. Ask your pharmacist about using those||
4352|238|I|products safely.||
4352|239|I|   Other medications can affect the removal of||
4352|240|I|hydrocodone/acetaminophen from your body, which may affect how it||
4352|241|I|works. Examples include azole antifungals (such as ketoconazole),||
4352|242|I|macrolide antibiotics (such as erythromycin), levoketoconazole,||
4352|243|I|mifepristone, HIV medications (such as tipranavir), rifamycins||
4352|244|I|(such as rifabutin, rifampin), ritonavir, certain drugs used to||
4352|245|I|treat seizures (such as carbamazepine, phenytoin), among others.||
4352|246|I|   This medication may interfere with certain lab tests (such as||
4352|247|I|amylase/lipase levels), possibly causing false test results. Make||
4352|248|I|sure lab personnel and all your doctors know you use this drug.||
4352|249|B|||
4352|250|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4352|251|O|as passing out or trouble breathing, give them naloxone or||
4352|252|O|nalmefene if available, then call 911. If the person is awake and||
4352|253|O|has no symptoms, call a poison control center right away. US||
4352|254|O|residents can call 1-800-222-1222. Canada residents can call||
4352|255|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
4352|256|O|breathing, nausea, vomiting, loss of appetite, sweating,||
4352|257|O|stomach/abdominal pain, extreme tiredness, slow heartbeat,||
4352|258|O|yellowing eyes/skin, dark urine, coma.||
4352|259|B|||
4352|260|N|NOTES:  Do not share this medication with others. Sharing it is||
4352|261|N|against the law.||
4352|262|N|   This medication has been prescribed for your current condition||
4352|263|N|only. Do not use it later for another condition unless your||
4352|264|N|doctor directs you to do so. A different medication may be||
4352|265|N|necessary in that case.||
4352|266|B|||
4352|267|D|MISSED DOSE:  If you are taking this product on a regular||
4352|268|D|schedule and miss a dose, take it as soon as you remember. If it||
4352|269|D|is near the time of the next dose, skip the missed dose. Take||
4352|270|D|your next dose at the regular time. Do not double the dose to||
4352|271|D|catch up.||
4352|272|B|||
4352|273|R|STORAGE:  Store at room temperature away from light and moisture.||
4352|274|R|Do not store in the bathroom. Keep all medications away from||
4352|275|R|children and pets.||
4352|276|R|   Do not flush medications down the toilet or pour them into a||
4352|277|R|drain unless instructed to do so. Properly discard this product||
4352|278|R|when it is expired or no longer needed. For more details, read||
4352|279|R|the Medication Guide, or consult your pharmacist or local waste||
4352|280|R|disposal company.||
4352|281|B|||
4352|282|A|Information last revised August 2025.||
4352|283|A|Copyright(c) 2025 First Databank, Inc.||
4352|284|B|||
4367|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4367|002|Z|does NOT have all possible information about this product. This||
4367|003|Z|information does not assure that this product is safe, effective,||
4367|004|Z|or appropriate for you. This information is not individual||
4367|005|Z|medical advice and does not substitute for the advice of your||
4367|006|Z|health care professional. Always ask your health care||
4367|007|Z|professional for complete information about this product and your||
4367|008|Z|specific health needs.||
4367|009|B|||
4367|010|T|DIAZEPAM - ORAL||
4367|011|F|(dye-AZ-e-pam)||
4367|012|B|||
4367|013|C|COMMON BRAND NAME(S): Valium||
4367|014|B|||
4367|015|W|WARNING:  Diazepam has a risk for abuse and addiction, which can||
4367|016|W|lead to overdose and death. Taking this medication with alcohol||
4367|017|W|or other drugs that can cause drowsiness or breathing problems||
4367|018|W|(especially opioid medications such as codeine, hydrocodone) may||
4367|019|W|cause very serious side effects, including death. To lower your||
4367|020|W|risk, your doctor should have you take the smallest dose of||
4367|021|W|diazepam that works, and take it for the shortest possible time.||
4367|022|W|Be sure you know how to take diazepam and what other drugs you||
4367|023|W|should avoid taking with it. See also Drug Interactions section.||
4367|024|W|Get medical help right away if any of these very serious side||
4367|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
4367|026|W|severe drowsiness/dizziness, difficulty waking up.||
4367|027|W|   Suddenly stopping this medication may cause serious (possibly||
4367|028|W|fatal) withdrawal, especially if you have used it for a long time||
4367|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
4367|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
4367|031|W|you have any withdrawal symptoms such as headaches, trouble||
4367|032|W|sleeping, restlessness, hallucinations/confusion, depression,||
4367|033|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
4367|034|W|to months.||
4367|035|B|||
4367|036|U|USES:  Diazepam is used to treat anxiety, alcohol withdrawal, and||
4367|037|U|seizures. It is also used to relieve muscle spasms and to provide||
4367|038|U|sedation before medical procedures. This medication works by||
4367|039|U|calming the brain and nerves. Diazepam belongs to a class of||
4367|040|U|drugs known as benzodiazepines.||
4367|041|B|||
4367|042|H|HOW TO USE:  See also Warning section.||
4367|043|H|   Read the Medication Guide provided by your pharmacist before||
4367|044|H|you start taking diazepam and each time you get a refill. If you||
4367|045|H|have any questions, ask your doctor or pharmacist.||
4367|046|H|   Take this medication by mouth with or without food as directed||
4367|047|H|by your doctor. If you are using the liquid form of this||
4367|048|H|medication, carefully measure the dose using a special measuring||
4367|049|H|device/spoon. Do not use a household spoon because you may not||
4367|050|H|get the correct dose.||
4367|051|H|   If you are using the concentrated solution, use the medicine||
4367|052|H|dropper provided and mix the measured dose with a small amount of||
4367|053|H|liquid or soft food (such as applesauce, pudding). Take all of||
4367|054|H|the mixture right away. Do not store the mixture for later use.||
4367|055|H|   The dosage is based on your medical condition, age, and||
4367|056|H|response to treatment. Do not increase your dose or use this drug||
4367|057|H|more often or for longer than prescribed. Your condition will not||
4367|058|H|improve any faster, and your risk of side effects will increase.||
4367|059|H|Properly stop the medication when so directed.||
4367|060|H|   When this medication is used for a long time, it may not work||
4367|061|H|as well. Talk with your doctor if this medication stops working||
4367|062|H|well.||
4367|063|H|   Though it helps many people, this medication may sometimes||
4367|064|H|cause addiction. This risk may be higher if you have a substance||
4367|065|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
4367|066|H|Take this medication exactly as prescribed to lower the risk of||
4367|067|H|addiction. Ask your doctor or pharmacist for more details.||
4367|068|H|   Avoid eating grapefruit or drinking grapefruit juice while||
4367|069|H|using this medication unless your doctor or pharmacist says you||
4367|070|H|may do so safely. Grapefruit can increase the chance of side||
4367|071|H|effects with this medicine. Ask your doctor or pharmacist for||
4367|072|H|more details.||
4367|073|H|   If directed by your doctor, take this medication regularly to||
4367|074|H|get the most benefit from it. To help you remember, take it at||
4367|075|H|the same time(s) each day.||
4367|076|H|   Tell your doctor if your condition lasts or gets worse.||
4367|077|B|||
4367|078|S|SIDE EFFECTS:  See also Warning section.||
4367|079|S|   Drowsiness, dizziness, tiredness, blurred vision, or||
4367|080|S|unsteadiness may occur. If any of these effects last or get||
4367|081|S|worse, tell your doctor or pharmacist promptly.||
4367|082|S|   Remember that this medication has been prescribed because your||
4367|083|S|doctor has judged that the benefit to you is greater than the||
4367|084|S|risk of side effects. Many people using this medication do not||
4367|085|S|have serious side effects.||
4367|086|S|   Tell your doctor right away if you have any serious side||
4367|087|S|effects, including: mental/mood changes (such as memory problems,||
4367|088|S|agitation, hallucinations, confusion, restlessness, depression),||
4367|089|S|trouble speaking, trouble walking, muscle weakness, shaking||
4367|090|S|(tremors), trouble urinating, yellowing eyes/skin, signs of||
4367|091|S|infection (such as sore throat that doesn't go away, fever,||
4367|092|S|chills).||
4367|093|S|   Get medical help right away if you have any very serious side||
4367|094|S|effects, including: slow/shallow breathing.||
4367|095|S|   A very serious allergic reaction to this drug is rare.||
4367|096|S|However, get medical help right away if you notice any symptoms||
4367|097|S|of a serious allergic reaction, including: rash, itching/swelling||
4367|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4367|099|S|breathing.||
4367|100|S|   This is not a complete list of possible side effects. If you||
4367|101|S|notice other effects not listed above, contact your doctor or||
4367|102|S|pharmacist.||
4367|103|S|   In the US -||
4367|104|S|   Call your doctor for medical advice about side effects. You||
4367|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4367|106|S|www.fda.gov/medwatch.||
4367|107|S|   In Canada - Call your doctor for medical advice about side||
4367|108|S|effects. You may report side effects to Health Canada at||
4367|109|S|1-866-234-2345.||
4367|110|B|||
4367|111|P|PRECAUTIONS:  Before taking diazepam, tell your doctor or||
4367|112|P|pharmacist if you are allergic to it; or to other benzodiazepines||
4367|113|P|(such as oxazepam, temazepam); or if you have any other||
4367|114|P|allergies. This product may contain inactive ingredients, which||
4367|115|P|can cause allergic reactions or other problems. Talk to your||
4367|116|P|pharmacist for more details.||
4367|117|P|   Before using this medication, tell your doctor or pharmacist||
4367|118|P|your medical history, especially of: a certain muscle disease||
4367|119|P|(myasthenia gravis), lung/breathing problems (such as COPD, sleep||
4367|120|P|apnea), mental/mood disorders (such as depression, thoughts of||
4367|121|P|suicide, psychosis), personal or family history of a substance||
4367|122|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
4367|123|P|glaucoma, liver disease, kidney disease.||
4367|124|P|   This drug may make you dizzy or drowsy or blur your vision.||
4367|125|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
4367|126|P|drowsy. Do not drive, use machinery, or do anything that needs||
4367|127|P|alertness or clear vision until you can do it safely. Avoid||
4367|128|P|alcoholic beverages. Talk to your doctor if you are using||
4367|129|P|marijuana (cannabis).||
4367|130|P|   Some liquid products may contain alcohol. Ask your doctor or||
4367|131|P|pharmacist about using this product safely.||
4367|132|P|   Before having surgery, tell your doctor or dentist about all||
4367|133|P|the products you use (including prescription drugs,||
4367|134|P|nonprescription drugs, and herbal products).||
4367|135|P|   For some children, instead of having a calming effect,||
4367|136|P|diazepam may have the opposite effect, causing mental/mood||
4367|137|P|changes (such as agitation, hallucinations, restlessness).||
4367|138|P|   Older adults may be more sensitive to the side effects of this||
4367|139|P|drug, especially drowsiness and loss of coordination. These side||
4367|140|P|effects can increase the risk of falling. For some older adults,||
4367|141|P|instead of having a calming effect, diazepam may have the||
4367|142|P|opposite effect, causing mental/mood changes (such as agitation,||
4367|143|P|hallucinations, restlessness).||
4367|144|P|   Tell your doctor if you are pregnant or plan to become||
4367|145|P|pregnant. You should not become pregnant while using diazepam.||
4367|146|P|Diazepam may harm an unborn baby. Newborn babies of mothers who||
4367|147|P|use this medication late in pregnancy may have symptoms such as||
4367|148|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
4367|149|P|feeding. If you become pregnant, talk to your doctor right away||
4367|150|P|about the risks and benefits of this medication.||
4367|151|P|   This medication passes into breast milk and may have||
4367|152|P|undesirable effects on a nursing infant. Breastfeeding is not||
4367|153|P|recommended while using this medication. Consult your doctor||
4367|154|P|before breastfeeding.||
4367|155|B|||
4367|156|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
4367|157|I|   Drug interactions may change how your medications work or||
4367|158|I|increase your risk for serious side effects. This document does||
4367|159|I|not contain all possible drug interactions. Keep a list of all||
4367|160|I|the products you use (including prescription/nonprescription||
4367|161|I|drugs and herbal products) and share it with your doctor and||
4367|162|I|pharmacist. Do not start, stop, or change the dosage of any||
4367|163|I|medicines without your doctor's approval.||
4367|164|I|   Some products that may interact with this drug include:||
4367|165|I|clozapine, fluvoxamine, orlistat, sodium oxybate.||
4367|166|I|   The risk of serious side effects (such as slow/shallow||
4367|167|I|breathing, severe drowsiness/dizziness) may be increased if this||
4367|168|I|medication is taken with other products that may also cause||
4367|169|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
4367|170|I|if you are taking other products such as opioid pain or cough||
4367|171|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
4367|172|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
4367|173|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
4367|174|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
4367|175|I|diphenhydramine).||
4367|176|I|   Check the labels on all your medicines (such as allergy or||
4367|177|I|cough-and-cold products) because they may contain ingredients||
4367|178|I|that cause drowsiness. Ask your pharmacist about using those||
4367|179|I|products safely.||
4367|180|I|   This medication may interfere with certain lab tests, possibly||
4367|181|I|causing false test results. Make sure lab personnel and all your||
4367|182|I|doctors know you use this drug.||
4367|183|B|||
4367|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4367|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4367|186|O|poison control center right away. US residents can call||
4367|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4367|188|O|Symptoms of overdose may include: severe drowsiness, slow||
4367|189|O|reflexes, slow/shallow breathing, fainting, loss of||
4367|190|O|consciousness.||
4367|191|B|||
4367|192|N|NOTES:  Do not share this medication with others. Sharing it is||
4367|193|N|against the law.||
4367|194|N|   If this drug is used for a long period of time, lab and/or||
4367|195|N|medical tests (such as liver function, complete blood count) may||
4367|196|N|be done while you are taking this medication. Keep all medical||
4367|197|N|and lab appointments.||
4367|198|B|||
4367|199|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4367|200|D|remember. If it is near the time of the next dose, skip the||
4367|201|D|missed dose. Take your next dose at the regular time. Do not||
4367|202|D|double the dose to catch up.||
4367|203|B|||
4367|204|R|STORAGE:  Store at room temperature away from light and moisture.||
4367|205|R|Do not store in the bathroom. For the concentrated solution, once||
4367|206|R|the bottle is opened, the medication expires after 90 days. Keep||
4367|207|R|all medications away from children and pets.||
4367|208|R|   Do not flush medications down the toilet or pour them into a||
4367|209|R|drain unless instructed to do so. Properly discard this product||
4367|210|R|when it is expired or no longer needed. Consult your pharmacist||
4367|211|R|or local waste disposal company.||
4367|212|B|||
4367|213|M|MEDICAL ALERT:  Your condition can cause complications in a||
4367|214|M|medical emergency. For information about enrolling in MedicAlert,||
4367|215|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
4367|216|B|||
4367|217|A|Information last revised January 2025.||
4367|218|A|Copyright(c) 2025 First Databank, Inc.||
4367|219|B|||
4372|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
4372|002|Z|does NOT have all possible information about this product. This||
4372|003|Z|information does not assure that this product is safe, effective,||
4372|004|Z|or appropriate for you. This information is not individual||
4372|005|Z|medical advice and does not substitute for the advice of your||
4372|006|Z|health care professional. Always ask your health care||
4372|007|Z|professional for complete information about this product and your||
4372|008|Z|specific health needs.||
4372|009|B|||
4372|010|T|VALSARTAN/HYDROCHLOROTHIAZIDE - ORAL||
4372|011|F|(val-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)||
4372|012|B|||
4372|013|C|COMMON BRAND NAME(S): Diovan HCT||
4372|014|B|||
4372|015|W|WARNING:  Valsartan can cause serious (possibly fatal) harm to an||
4372|016|W|unborn baby if used during pregnancy. It is important to prevent||
4372|017|W|pregnancy while taking this medication. Consult your doctor for||
4372|018|W|more details and to discuss the use of reliable forms of birth||
4372|019|W|control while taking this medication. If you are planning||
4372|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
4372|021|W|your doctor right away.||
4372|022|B|||
4372|023|U|USES:  This drug is used to treat high blood pressure. Lowering||
4372|024|U|high blood pressure helps prevent strokes, heart attacks, and||
4372|025|U|kidney problems. This product contains two medications: valsartan||
4372|026|U|and hydrochlorothiazide. Valsartan is an angiotensin receptor||
4372|027|U|blocker (ARB) and works by relaxing blood vessels so that blood||
4372|028|U|can flow more easily. Hydrochlorothiazide is a "water pill"||
4372|029|U|(diuretic) that causes you to make more urine, which helps your||
4372|030|U|body get rid of extra salt and water.||
4372|031|B|||
4372|032|V|OTHER USES:  This section contains uses of this drug that are not||
4372|033|V|listed in the approved professional labeling for the drug but||
4372|034|V|that may be prescribed by your health care professional. Use this||
4372|035|V|drug for a condition that is listed in this section only if it||
4372|036|V|has been so prescribed by your health care professional.||
4372|037|V|   This drug may also be used for heart failure.||
4372|038|B|||
4372|039|H|HOW TO USE:  Read the Patient Information Leaflet if available||
4372|040|H|from your pharmacist before you start taking this medication and||
4372|041|H|each time you get a refill. If you have any questions, ask your||
4372|042|H|doctor or pharmacist.||
4372|043|H|   Take this medication by mouth with or without food as directed||
4372|044|H|by your doctor, usually once daily. If this medication causes you||
4372|045|H|to urinate more often, it is best to take it at least 4 hours||
4372|046|H|before your bedtime to prevent having to get up to urinate.||
4372|047|H|   If you also take certain drugs to lower your cholesterol (bile||
4372|048|H|acid-binding resins such as cholestyramine or colestipol), take||
4372|049|H|this product at least 4 hours before or at least 4 to 6 hours||
4372|050|H|after these medications.||
4372|051|H|   The dosage is based on your medical condition and response to||
4372|052|H|treatment.||
4372|053|H|   Use this medication regularly to get the most benefit from it.||
4372|054|H|To help you remember, take it at the same time each day. Keep||
4372|055|H|taking this medication even if you feel well. Most people with||
4372|056|H|high blood pressure do not feel sick.||
4372|057|H|   Tell your doctor if your condition does not get better or if||
4372|058|H|it gets worse (your blood pressure readings remain high or||
4372|059|H|increase).||
4372|060|B|||
4372|061|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
4372|062|S|body adjusts to the medication. If either of these effects lasts||
4372|063|S|or gets worse, tell your doctor or pharmacist promptly.||
4372|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
4372|065|S|slowly when rising from a sitting or lying position.||
4372|066|S|   Remember that this medication has been prescribed because your||
4372|067|S|doctor has judged that the benefit to you is greater than the||
4372|068|S|risk of side effects. Many people using this medication do not||
4372|069|S|have serious side effects.||
4372|070|S|   This product may cause dehydration and electrolyte imbalance.||
4372|071|S|Tell your doctor right away if you have any symptoms of||
4372|072|S|dehydration or electrolyte imbalance, including unusual dry||
4372|073|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
4372|074|S|heartbeat, or confusion.||
4372|075|S|   Tell your doctor right away if you have any serious side||
4372|076|S|effects, including: fainting, decrease in vision, eye pain, signs||
4372|077|S|of kidney problems (such as change in the amount of urine).||
4372|078|S|   A very serious allergic reaction to this drug is rare.||
4372|079|S|However, get medical help right away if you notice any symptoms||
4372|080|S|of a serious allergic reaction, including: rash, itching/swelling||
4372|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
4372|082|S|breathing.||
4372|083|S|   This is not a complete list of possible side effects. If you||
4372|084|S|notice other effects not listed above, contact your doctor or||
4372|085|S|pharmacist.||
4372|086|S|   In the US -||
4372|087|S|   Call your doctor for medical advice about side effects. You||
4372|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
4372|089|S|www.fda.gov/medwatch.||
4372|090|S|   In Canada - Call your doctor for medical advice about side||
4372|091|S|effects. You may report side effects to Health Canada at||
4372|092|S|1-866-234-2345.||
4372|093|B|||
4372|094|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
4372|095|P|pharmacist if you are allergic to valsartan or||
4372|096|P|hydrochlorothiazide; or if you have any other allergies. This||
4372|097|P|product may contain inactive ingredients, which can cause||
4372|098|P|allergic reactions or other problems. Talk to your pharmacist for||
4372|099|P|more details.||
4372|100|P|   Before using this medication, tell your doctor or pharmacist||
4372|101|P|your medical history, especially of: gout, kidney disease, liver||
4372|102|P|disease, lupus, dehydration, high level of potassium in the||
4372|103|P|blood, skin cancer.||
4372|104|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
4372|105|P|can make you more dizzy. Do not drive, use machinery, or do||
4372|106|P|anything that needs alertness until you can do it safely. Limit||
4372|107|P|alcoholic beverages. Talk to your doctor if you are using||
4372|108|P|marijuana (cannabis).||
4372|109|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
4372|110|P|and cause you to feel lightheaded. Tell your doctor if you have||
4372|111|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
4372|112|P|of fluids unless your doctor tells you not to.||
4372|113|P|   If you have diabetes, this product may affect your blood||
4372|114|P|sugar. Check your blood sugar regularly as directed and share the||
4372|115|P|results with your doctor. Your doctor may need to adjust your||
4372|116|P|diabetes medication, exercise program, or diet.||
4372|117|P|   This medication may make you more sensitive to the sun. It may||
4372|118|P|also increase your risk for skin cancer, especially if you take||
4372|119|P|it for a long time. Limit your time in the sun. Avoid tanning||
4372|120|P|booths and sunlamps. Use sunscreen and wear protective clothing||
4372|121|P|when outdoors. Tell your doctor right away if you get sunburned,||
4372|122|P|have skin blisters/redness, or notice new or changed moles/skin||
4372|123|P|lesions.||
4372|124|P|   This product may affect your potassium levels. Before using||
4372|125|P|potassium supplements or salt substitutes that contain potassium,||
4372|126|P|consult your doctor or pharmacist.||
4372|127|P|   Before having surgery, tell your doctor or dentist about all||
4372|128|P|the products you use (including prescription drugs,||
4372|129|P|nonprescription drugs, and herbal products).||
4372|130|P|   Older adults may be more sensitive to the side effects of this||
4372|131|P|drug, especially dizziness and change in the amount of urine||
4372|132|P|(kidney problems).||
4372|133|P|   Tell your doctor if you are pregnant or plan to become||
4372|134|P|pregnant. You should not become pregnant while using||
4372|135|P|valsartan/hydrochlorothiazide. Valsartan may harm an unborn baby.||
4372|136|P|If you become pregnant, talk to your doctor right away about the||
4372|137|P|risks and benefits of this medication. (See also Warning||
4372|138|P|section.)||
4372|139|P|   It is unknown if valsartan passes into breast milk.||
4372|140|P|Hydrochlorothiazide passes into breast milk, but is unlikely to||
4372|141|P|harm a nursing infant. Consult your doctor before breastfeeding.||
4372|142|B|||
4372|143|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
4372|144|I|   Drug interactions may change how your medications work or||
4372|145|I|increase your risk for serious side effects. This document does||
4372|146|I|not contain all possible drug interactions. Keep a list of all||
4372|147|I|the products you use (including prescription/nonprescription||
4372|148|I|drugs and herbal products) and share it with your doctor and||
4372|149|I|pharmacist. Do not start, stop, or change the dosage of any||
4372|150|I|medicines without your doctor's approval.||
4372|151|I|   Some products that may interact with this drug include:||
4372|152|I|aliskiren, dofetilide, lithium, drugs that may increase the level||
4372|153|I|of potassium in the blood (such as sparsentan, ACE inhibitors||
4372|154|I|including benazepril/lisinopril, birth control pills containing||
4372|155|I|drospirenone).||
4372|156|I|   Some products have ingredients that could raise your blood||
4372|157|I|pressure or worsen your heart failure. Tell your pharmacist what||
4372|158|I|products you are using, and ask how to use them safely||
4372|159|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
4372|160|I|ibuprofen/naproxen).||
4372|161|I|   This medication may interfere with certain lab tests (such as||
4372|162|I|parathyroid function), possibly causing false test results. Make||
4372|163|I|sure lab personnel and all your doctors know you use this drug.||
4372|164|B|||
4372|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
4372|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
4372|167|O|poison control center right away. US residents can call||
4372|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
4372|169|O|Symptoms of overdose may include: severe dizziness, fainting.||
4372|170|B|||
4372|171|N|NOTES:  Do not share this medication with others.||
4372|172|N|   Lifestyle changes that may help this medication work better||
4372|173|N|include exercising, stopping smoking, and eating a||
4372|174|N|low-cholesterol/low-fat diet. Consult your doctor for more||
4372|175|N|details.||
4372|176|N|   Lab and/or medical tests (such as kidney function, potassium||
4372|177|N|levels, skin exams, cholesterol levels) should be done while you||
4372|178|N|are taking this product. Keep all medical and lab appointments.||
4372|179|N|   Check your blood pressure regularly while taking this||
4372|180|N|medication. Learn how to monitor your own blood pressure, and||
4372|181|N|share the results with your doctor.||
4372|182|B|||
4372|183|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
4372|184|D|remember. If it is near the time of the next dose, skip the||
4372|185|D|missed dose. Take your next dose at the regular time. Do not||
4372|186|D|double the dose to catch up.||
4372|187|B|||
4372|188|R|STORAGE:  Store at room temperature away from light and moisture.||
4372|189|R|Do not store in the bathroom. Keep all medications away from||
4372|190|R|children and pets.||
4372|191|R|   Do not flush medications down the toilet or pour them into a||
4372|192|R|drain unless instructed to do so. Properly discard this product||
4372|193|R|when it is expired or no longer needed. Consult your pharmacist||
4372|194|R|or local waste disposal company.||
4372|195|B|||
4372|196|A|Information last revised March 2025.||
4372|197|A|Copyright(c) 2025 First Databank, Inc.||
4372|198|B|||
5003|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5003|002|Z|does NOT have all possible information about this product. This||
5003|003|Z|information does not assure that this product is safe, effective,||
5003|004|Z|or appropriate for you. This information is not individual||
5003|005|Z|medical advice and does not substitute for the advice of your||
5003|006|Z|health care professional. Always ask your health care||
5003|007|Z|professional for complete information about this product and your||
5003|008|Z|specific health needs.||
5003|009|B|||
5003|010|T|OLSALAZINE - ORAL||
5003|011|F|(ohl-SAL-uh-zeen)||
5003|012|B|||
5003|013|C|COMMON BRAND NAME(S): Dipentum||
5003|014|B|||
5003|015|U|USES:  Olsalazine is used to treat a certain type of bowel||
5003|016|U|disease called ulcerative colitis. It does not cure ulcerative||
5003|017|U|colitis, but it may decrease symptoms such as stomach pain,||
5003|018|U|diarrhea, and rectal bleeding caused by irritation/swelling of||
5003|019|U|the colon/rectum. After an attack is treated, olsalazine is used||
5003|020|U|to increase the amount of time between attacks.||
5003|021|U|   Olsalazine is an aminosalicylate anti-inflammatory drug. It is||
5003|022|U|believed to work by blocking the production of certain natural||
5003|023|U|substances (such as prostaglandins) that may cause pain and||
5003|024|U|swelling.||
5003|025|B|||
5003|026|V|OTHER USES:  This section contains uses of this drug that are not||
5003|027|V|listed in the approved professional labeling for the drug but||
5003|028|V|that may be prescribed by your health care professional. Use this||
5003|029|V|drug for a condition that is listed in this section only if it||
5003|030|V|has been so prescribed by your health care professional.||
5003|031|V|   This drug may also be used for another type of bowel disease||
5003|032|V|called Crohn's disease.||
5003|033|B|||
5003|034|H|HOW TO USE:  Take this medication by mouth as directed by your||
5003|035|H|doctor, usually twice a day about 12 hours apart. Take with food||
5003|036|H|or after meals to prevent stomach upset. The dosage is based on||
5003|037|H|your medical condition and response to treatment.||
5003|038|H|   Drink plenty of fluids during treatment with this medication||
5003|039|H|unless otherwise directed by your doctor. This will help prevent||
5003|040|H|kidney stones.||
5003|041|H|   Use this medication regularly in order to get the most benefit||
5003|042|H|from it. To help you remember, take it at the same times each||
5003|043|H|day.||
5003|044|H|   Tell your doctor if your condition does not get better or if||
5003|045|H|it gets worse.||
5003|046|B|||
5003|047|S|SIDE EFFECTS:  Headache, nausea, vomiting, or loss of appetite||
5003|048|S|may occur. If any of these effects last or get worse, tell your||
5003|049|S|doctor or pharmacist promptly.||
5003|050|S|   Remember that this medication has been prescribed because your||
5003|051|S|doctor has judged that the benefit to you is greater than the||
5003|052|S|risk of side effects. Many people using this medication do not||
5003|053|S|have serious side effects.||
5003|054|S|   Tell your doctor right away if diarrhea occurs. Your doctor||
5003|055|S|may need to lower your dose or prescribe another medication to||
5003|056|S|treat the diarrhea.||
5003|057|S|   Tell your doctor right away if you have any serious side||
5003|058|S|effects, including: nausea/vomiting that doesn't stop, severe||
5003|059|S|stomach/abdominal pain, pale stools, unusual tiredness, signs of||
5003|060|S|kidney problems (such as change in the amount of urine, blood in||
5003|061|S|the urine), dark urine, yellowing eyes/skin, easy||
5003|062|S|bruising/bleeding.||
5003|063|S|   A very serious allergic reaction to this drug is rare.||
5003|064|S|However, get medical help right away if you notice any symptoms||
5003|065|S|of a serious allergic reaction, including: fever, swollen lymph||
5003|066|S|nodes, rash, itching/swelling (especially of the||
5003|067|S|face/tongue/throat), severe dizziness, trouble breathing.||
5003|068|S|   This is not a complete list of possible side effects. If you||
5003|069|S|notice other effects not listed above, contact your doctor or||
5003|070|S|pharmacist.||
5003|071|S|   In the US -||
5003|072|S|   Call your doctor for medical advice about side effects. You||
5003|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5003|074|S|www.fda.gov/medwatch.||
5003|075|S|   In Canada - Call your doctor for medical advice about side||
5003|076|S|effects. You may report side effects to Health Canada at||
5003|077|S|1-866-234-2345.||
5003|078|B|||
5003|079|P|PRECAUTIONS:  Before taking olsalazine, tell your doctor or||
5003|080|P|pharmacist if you are allergic to it; or to aspirin or related||
5003|081|P|drugs (salicylates such as mesalamine, NSAIDs such as ibuprofen,||
5003|082|P|balsalazide, sulfasalazine); or if you have any other allergies.||
5003|083|P|This product may contain inactive ingredients, which can cause||
5003|084|P|allergic reactions or other problems. Talk to your pharmacist for||
5003|085|P|more details.||
5003|086|P|   Before using this medication, tell your doctor or pharmacist||
5003|087|P|your medical history, especially of: asthma, growths in the nose||
5003|088|P|(nasal polyps), kidney problems, liver problems, radiation||
5003|089|P|treatment in the pelvic area.||
5003|090|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
5003|091|P|may increase your risk for stomach bleeding, especially when||
5003|092|P|combined with this medicine. Check with your doctor or pharmacist||
5003|093|P|for more information.||
5003|094|P|   This medication is similar to aspirin. Children and teenagers||
5003|095|P|younger than 18 years should not take aspirin or aspirin-related||
5003|096|P|medications (such as salicylates) if they have chickenpox, flu,||
5003|097|P|or any undiagnosed illness, or if they have just been given a||
5003|098|P|live virus vaccine (such as varicella vaccine), without first||
5003|099|P|consulting a doctor about Reye's syndrome, a rare but serious||
5003|100|P|illness.||
5003|101|P|   This medication may make you more sensitive to the sun. Limit||
5003|102|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5003|103|P|sunscreen and wear protective clothing when outdoors. Tell your||
5003|104|P|doctor right away if you get sunburned or have skin||
5003|105|P|blisters/redness.||
5003|106|P|   Before having surgery, tell your doctor or dentist about all||
5003|107|P|the products you use (including prescription drugs,||
5003|108|P|nonprescription drugs, and herbal products).||
5003|109|P|   During pregnancy, this drug should be used only when clearly||
5003|110|P|needed. Discuss the risks and benefits with your doctor.||
5003|111|P|   This drug may pass into breast milk and could have undesirable||
5003|112|P|effects on a nursing infant. Consult your doctor before||
5003|113|P|breastfeeding.||
5003|114|B|||
5003|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5003|116|I|medications work or increase your risk for serious side effects.||
5003|117|I|This document does not contain all possible drug interactions.||
5003|118|I|Keep a list of all the products you use (including||
5003|119|I|prescription/nonprescription drugs and herbal products) and share||
5003|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
5003|121|I|the dosage of any medicines without your doctor's approval.||
5003|122|I|   Some products that may interact with this drug include:||
5003|123|I|mercaptopurine, thioguanine.||
5003|124|I|   Olsalazine is very similar to mesalamine. Do not use||
5003|125|I|mesalamine medications taken by mouth while using olsalazine.||
5003|126|I|   This medication may interfere with certain lab tests (such as||
5003|127|I|urine normetanephrine levels), possibly causing false test||
5003|128|I|results. Make sure lab personnel and all your doctors know you||
5003|129|I|use this drug.||
5003|130|B|||
5003|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5003|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5003|133|O|poison control center right away. US residents can call||
5003|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5003|135|B|||
5003|136|N|NOTES:  Do not share this medication with others.||
5003|137|N|   Lab and/or medical tests (such as kidney/liver function) may||
5003|138|N|be done while you are taking this medication. Keep all medical||
5003|139|N|and lab appointments. Consult your doctor for more details.||
5003|140|B|||
5003|141|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5003|142|D|remember. If it is near the time of the next dose, skip the||
5003|143|D|missed dose. Take your next dose at the regular time. Do not||
5003|144|D|double the dose to catch up.||
5003|145|B|||
5003|146|R|STORAGE:  Store at room temperature away from light and moisture.||
5003|147|R|Do not store in the bathroom. Keep all medications away from||
5003|148|R|children and pets.||
5003|149|R|   Do not flush medications down the toilet or pour them into a||
5003|150|R|drain unless instructed to do so. Properly discard this product||
5003|151|R|when it is expired or no longer needed. Consult your pharmacist||
5003|152|R|or local waste disposal company.||
5003|153|B|||
5003|154|A|Information last revised November 2025.||
5003|155|A|Copyright(c) 2025 First Databank, Inc.||
5003|156|B|||
5005|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5005|002|Z|does NOT have all possible information about this product. This||
5005|003|Z|information does not assure that this product is safe, effective,||
5005|004|Z|or appropriate for you. This information is not individual||
5005|005|Z|medical advice and does not substitute for the advice of your||
5005|006|Z|health care professional. Always ask your health care||
5005|007|Z|professional for complete information about this product and your||
5005|008|Z|specific health needs.||
5005|009|B|||
5005|010|T|OXCARBAZEPINE - ORAL||
5005|011|F|(ox-kar-BAY-zih-peen)||
5005|012|B|||
5005|013|C|COMMON BRAND NAME(S): Trileptal||
5005|014|B|||
5005|015|U|USES:  Oxcarbazepine is used alone or with other medications to||
5005|016|U|treat seizure disorders (epilepsy).||
5005|017|B|||
5005|018|V|OTHER USES:  This section contains uses of this drug that are not||
5005|019|V|listed in the approved professional labeling for the drug but||
5005|020|V|that may be prescribed by your health care professional. Use this||
5005|021|V|drug for a condition that is listed in this section only if it||
5005|022|V|has been so prescribed by your health care professional.||
5005|023|V|   This drug may also be used for certain types of nerve pain||
5005|024|V|(such as trigeminal neuralgia).||
5005|025|B|||
5005|026|H|HOW TO USE:  Read the Medication Guide provided by your||
5005|027|H|pharmacist before you start using oxcarbazepine and each time you||
5005|028|H|get a refill. If you have any questions, ask your doctor or||
5005|029|H|pharmacist.||
5005|030|H|   Take this medication by mouth with or without food as directed||
5005|031|H|by your doctor, usually twice daily. The dosage is based on your||
5005|032|H|medical condition, response to treatment, and other medications||
5005|033|H|you may be taking. Children's dosage is also based on weight. To||
5005|034|H|reduce your risk of side effects, your doctor may direct you to||
5005|035|H|start this medication at a low dose and gradually increase your||
5005|036|H|dose. Follow your doctor's instructions carefully. Be sure to||
5005|037|H|tell your doctor and pharmacist about all the products you use||
5005|038|H|(including prescription drugs, nonprescription drugs, and herbal||
5005|039|H|products).||
5005|040|H|   Use this medication regularly to get the most benefit from it.||
5005|041|H|To help you remember, take it at the same times each day.||
5005|042|H|   Do not stop taking this medication without consulting your||
5005|043|H|doctor. Some conditions (such as seizures) may become worse when||
5005|044|H|this drug is suddenly stopped. Your dose may need to be gradually||
5005|045|H|decreased.||
5005|046|H|   Tell your doctor if your seizures get worse.||
5005|047|B|||
5005|048|S|SIDE EFFECTS:  Dizziness, drowsiness, tiredness, nausea/vomiting,||
5005|049|S|stomach/abdominal pain, headache, trouble sleeping, or||
5005|050|S|constipation may occur. If any of these effects last or get||
5005|051|S|worse, tell your doctor or pharmacist promptly.||
5005|052|S|   Remember that this medication has been prescribed because your||
5005|053|S|doctor has judged that the benefit to you is greater than the||
5005|054|S|risk of side effects. Many people using this medication do not||
5005|055|S|have serious side effects.||
5005|056|S|   A small number of people who take anticonvulsants for any||
5005|057|S|condition (such as seizure, bipolar disorder, pain) may||
5005|058|S|experience depression, suicidal thoughts/attempts, or other||
5005|059|S|mental/mood problems. Tell your doctor right away if you or your||
5005|060|S|family/caregiver notice any unusual/sudden changes in your mood,||
5005|061|S|thoughts, or behavior including signs of depression, suicidal||
5005|062|S|thoughts/attempts, thoughts about harming yourself.||
5005|063|S|   Tell your doctor right away if you have any serious side||
5005|064|S|effects, including: loss of coordination, vision changes (such as||
5005|065|S|double vision), rapid/uncontrollable eye movements, shaking||
5005|066|S|(tremor), easy bleeding/bruising, unusual tiredness.||
5005|067|S|   Get medical help right away if you have any very serious side||
5005|068|S|effects, including: signs of infection ((such as sore throat that||
5005|069|S|doesn't go away, fever, swollen lymph nodes, chills), symptoms of||
5005|070|S|low sodium level (severe nausea, extreme drowsiness, confusion,||
5005|071|S|seizures).||
5005|072|S|   Oxcarbazepine may rarely cause very serious (possibly fatal)||
5005|073|S|skin reactions. Some people in certain ethnic groups (including||
5005|074|S|people of Asian/South Asian descent) are at greater risk. Your||
5005|075|S|doctor may order a blood test to measure your risk before you||
5005|076|S|start this medication. If the blood test shows you are at greater||
5005|077|S|risk, your doctor should discuss the risks and benefits of||
5005|078|S|oxcarbazepine and other treatment choices with you. Such skin||
5005|079|S|reactions have developed mostly within the first few months of||
5005|080|S|treatment. Get medical help right away if you develop symptoms of||
5005|081|S|a serious skin reaction such as skin rash/blisters/peeling,||
5005|082|S|itching, or swelling. Ask your doctor or pharmacist for more||
5005|083|S|details.||
5005|084|S|   A very serious allergic reaction to this drug is rare.||
5005|085|S|However, get medical help right away if you notice any symptoms||
5005|086|S|of a serious allergic reaction, including: rash, itching/swelling||
5005|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5005|088|S|breathing.||
5005|089|S|   This is not a complete list of possible side effects. If you||
5005|090|S|notice other effects not listed above, contact your doctor or||
5005|091|S|pharmacist.||
5005|092|S|   In the US -||
5005|093|S|   Call your doctor for medical advice about side effects. You||
5005|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5005|095|S|www.fda.gov/medwatch.||
5005|096|S|   In Canada - Call your doctor for medical advice about side||
5005|097|S|effects. You may report side effects to Health Canada at||
5005|098|S|1-866-234-2345.||
5005|099|B|||
5005|100|P|PRECAUTIONS:  Before taking oxcarbazepine, tell your doctor or||
5005|101|P|pharmacist if you are allergic to it; or to carbamazepine or||
5005|102|P|eslicarbazepine; or to other anti-seizure medications (such as||
5005|103|P|fosphenytoin, phenobarbital, phenytoin, primidone); or if you||
5005|104|P|have any other allergies. This product may contain inactive||
5005|105|P|ingredients, which can cause allergic reactions or other||
5005|106|P|problems. Talk to your pharmacist for more details.||
5005|107|P|   Before using this medication, tell your doctor or pharmacist||
5005|108|P|your medical history, especially of: kidney disease, mineral||
5005|109|P|imbalance (low level of sodium in the blood).||
5005|110|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5005|111|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5005|112|P|machinery, or do anything that needs alertness until you can do||
5005|113|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5005|114|P|are using marijuana (cannabis).||
5005|115|P|   Before having surgery, tell your doctor or dentist about all||
5005|116|P|the products you use (including prescription drugs,||
5005|117|P|nonprescription drugs, and herbal products).||
5005|118|P|   Younger children may be more sensitive to the side effects of||
5005|119|P|this drug, especially infections.||
5005|120|P|   During pregnancy, this medication should be used only when||
5005|121|P|clearly needed. It may harm an unborn baby. However, since||
5005|122|P|untreated seizures are a serious condition that can harm both a||
5005|123|P|pregnant woman and her unborn baby, do not stop taking this||
5005|124|P|medication unless directed by your doctor. If you are planning||
5005|125|P|pregnancy, become pregnant, or think you may be pregnant, discuss||
5005|126|P|with your doctor right away the benefits and risks of using this||
5005|127|P|medication during pregnancy. Since hormonal birth control may not||
5005|128|P|work if taken with this medication (see also Drug Interactions||
5005|129|P|section), discuss reliable forms of birth control with your||
5005|130|P|doctor.||
5005|131|P|   This medication passes into breast milk but is unlikely to||
5005|132|P|harm a nursing infant. Consult your doctor before breastfeeding.||
5005|133|B|||
5005|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5005|135|I|medications work or increase your risk for serious side effects.||
5005|136|I|This document does not contain all possible drug interactions.||
5005|137|I|Keep a list of all the products you use (including||
5005|138|I|prescription/nonprescription drugs and herbal products) and share||
5005|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
5005|140|I|the dosage of any medicines without your doctor's approval.||
5005|141|I|   A product that may interact with this drug is: orlistat.||
5005|142|I|   This medication can speed up or slow down the removal of other||
5005|143|I|medications from your body, which may affect how they work.||
5005|144|I|Examples of affected drugs include cabotegravir, cobicistat,||
5005|145|I|elvitegravir, sofosbuvir, rilpivirine, among others.||
5005|146|I|   This medication may decrease the effectiveness of hormonal||
5005|147|I|birth control such as pills, patch, or ring. This could cause||
5005|148|I|pregnancy. Discuss with your doctor or pharmacist if you should||
5005|149|I|use reliable backup birth control methods while using this||
5005|150|I|medication. Also tell your doctor if you have any new spotting or||
5005|151|I|breakthrough bleeding, because these may be signs that your birth||
5005|152|I|control is not working well.||
5005|153|I|   Tell your doctor or pharmacist if you are taking other||
5005|154|I|products that cause drowsiness including alcohol, marijuana||
5005|155|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
5005|156|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
5005|157|I|zolpidem), muscle relaxants (such as carisoprodol,||
5005|158|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
5005|159|I|hydrocodone).||
5005|160|I|   Check the labels on all your medicines (such as allergy or||
5005|161|I|cough-and-cold products) because they may contain ingredients||
5005|162|I|that cause drowsiness. Ask your pharmacist about using those||
5005|163|I|products safely.||
5005|164|I|   Oxcarbazepine is very similar to eslicarbazepine. Do not use||
5005|165|I|medications containing eslicarbazepine while using oxcarbazepine.||
5005|166|B|||
5005|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5005|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5005|169|O|poison control center right away. US residents can call||
5005|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5005|171|B|||
5005|172|N|NOTES:  Do not share this medication with others.||
5005|173|N|   Lab and/or medical tests (such as sodium levels, complete||
5005|174|N|blood count) should be done while you are taking this medication.||
5005|175|N|Keep all medical and lab appointments. Consult your doctor for||
5005|176|N|more details.||
5005|177|B|||
5005|178|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5005|179|D|remember. If it is near the time of the next dose, skip the||
5005|180|D|missed dose. Take your next dose at the regular time. Do not||
5005|181|D|double the dose to catch up.||
5005|182|B|||
5005|183|R|STORAGE:  Store at room temperature away from light and moisture.||
5005|184|R|Do not store in the bathroom. Keep all medications away from||
5005|185|R|children and pets.||
5005|186|R|   Do not flush medications down the toilet or pour them into a||
5005|187|R|drain unless instructed to do so. Properly discard this product||
5005|188|R|when it is expired or no longer needed. Consult your pharmacist||
5005|189|R|or local waste disposal company.||
5005|190|B|||
5005|191|M|MEDICAL ALERT:  Your condition can cause complications in a||
5005|192|M|medical emergency. For information about enrolling in MedicAlert,||
5005|193|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5005|194|B|||
5005|195|A|Information last revised May 2025.||
5005|196|A|Copyright(c) 2025 First Databank, Inc.||
5005|197|B|||
5006|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5006|002|Z|does NOT have all possible information about this product. This||
5006|003|Z|information does not assure that this product is safe, effective,||
5006|004|Z|or appropriate for you. This information is not individual||
5006|005|Z|medical advice and does not substitute for the advice of your||
5006|006|Z|health care professional. Always ask your health care||
5006|007|Z|professional for complete information about this product and your||
5006|008|Z|specific health needs.||
5006|009|B|||
5006|010|T|BROMAZEPAM - ORAL||
5006|011|F|(broe-MAZ-e-PAM)||
5006|012|B|||
5006|013|W|WARNING:  Bromazepam has a risk for abuse and addiction, which||
5006|014|W|can lead to overdose and death. Taking this medication with||
5006|015|W|alcohol or other drugs that can cause drowsiness or breathing||
5006|016|W|problems (especially opioid medications such as codeine,||
5006|017|W|hydrocodone) may cause very serious side effects, including||
5006|018|W|death. To lower your risk, your doctor should have you take the||
5006|019|W|smallest dose of bromazepam that works, and take it for the||
5006|020|W|shortest possible time. Be sure you know how to take bromazepam||
5006|021|W|and what other drugs you should avoid taking with it. See also||
5006|022|W|Drug Interactions section. Get medical help right away if any of||
5006|023|W|these very serious side effects occur: slow/shallow breathing,||
5006|024|W|unusual lightheadedness, severe drowsiness/dizziness, difficulty||
5006|025|W|waking up.||
5006|026|W|   Suddenly stopping this medication may cause serious (possibly||
5006|027|W|fatal) withdrawal, especially if you have used it for a long time||
5006|028|W|or in high doses. To prevent withdrawal, your doctor may lower||
5006|029|W|your dose slowly. Tell your doctor or pharmacist right away if||
5006|030|W|you have any withdrawal symptoms such as headaches, trouble||
5006|031|W|sleeping, restlessness, hallucinations/confusion, depression,||
5006|032|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
5006|033|W|to months.||
5006|034|B|||
5006|035|U|USES:  This medication is used for the short-term treatment of||
5006|036|U|anxiety. Bromazepam belongs to a class of drugs known as||
5006|037|U|benzodiazepines. It acts on the brain and nerves (central nervous||
5006|038|U|system) to produce a calming effect.||
5006|039|B|||
5006|040|H|HOW TO USE:  See also Warning section.||
5006|041|H|   Take this medication by mouth with or without food as directed||
5006|042|H|by your doctor.||
5006|043|H|   The dosage is based on your medical condition and response to||
5006|044|H|treatment. If your doctor directs you to take this medication on||
5006|045|H|a schedule, use it regularly to get the most benefit from it. To||
5006|046|H|help you remember, use it at the same time(s) each day.||
5006|047|H|   When this medication is used for a long time, it may not work||
5006|048|H|as well. Talk with your doctor if this medication stops working||
5006|049|H|well.||
5006|050|H|   Though it helps many people, this medication may sometimes||
5006|051|H|cause addiction. This risk may be higher if you have a substance||
5006|052|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
5006|053|H|Take this medication exactly as prescribed to lower the risk of||
5006|054|H|addiction. Ask your doctor or pharmacist for more details.||
5006|055|H|   Tell your doctor if your condition lasts or gets worse.||
5006|056|B|||
5006|057|S|SIDE EFFECTS:  See also Warning section.||
5006|058|S|   Drowsiness, dizziness, or loss of coordination may occur. If||
5006|059|S|any of these effects last or get worse, tell your doctor or||
5006|060|S|pharmacist promptly.||
5006|061|S|   Remember that this medication has been prescribed because your||
5006|062|S|doctor has judged that the benefit to you is greater than the||
5006|063|S|risk of side effects. Many people using this medication do not||
5006|064|S|have serious side effects.||
5006|065|S|   Tell your doctor right away if you have any serious side||
5006|066|S|effects, including: mental/mood changes (such as irritability,||
5006|067|S|agitation, depression), memory loss.||
5006|068|S|   Get medical help right away if you have any very serious side||
5006|069|S|effects, including: slow/shallow breathing.||
5006|070|S|   A very serious allergic reaction to this drug is rare.||
5006|071|S|However, get medical help right away if you notice any symptoms||
5006|072|S|of a serious allergic reaction, including: rash, itching/swelling||
5006|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5006|074|S|breathing.||
5006|075|S|   This is not a complete list of possible side effects. If you||
5006|076|S|notice other effects not listed above, contact your doctor or||
5006|077|S|pharmacist.||
5006|078|S|   In the US -||
5006|079|S|   Call your doctor for medical advice about side effects. You||
5006|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5006|081|S|www.fda.gov/medwatch.||
5006|082|S|   In Canada - Call your doctor for medical advice about side||
5006|083|S|effects. You may report side effects to Health Canada at||
5006|084|S|1-866-234-2345.||
5006|085|B|||
5006|086|P|PRECAUTIONS:  Before taking bromazepam, tell your doctor or||
5006|087|P|pharmacist if you are allergic to it; or to other benzodiazepines||
5006|088|P|(such as diazepam, lorazepam); or if you have any other||
5006|089|P|allergies. This product may contain inactive ingredients, which||
5006|090|P|can cause allergic reactions or other problems. Talk to your||
5006|091|P|pharmacist for more details.||
5006|092|P|   Before using this medication, tell your doctor or pharmacist||
5006|093|P|your medical history, especially of: a certain muscle/nerve||
5006|094|P|condition (myasthenia gravis), mental/mood disorders (such as||
5006|095|P|depression, psychosis), kidney disease, liver disease, personal||
5006|096|P|or family history of a substance use disorder (such as overuse of||
5006|097|P|or addiction to drugs/alcohol), glaucoma, lung/breathing problems||
5006|098|P|(chronic obstructive pulmonary disorder-COPD, sleep apnea).||
5006|099|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5006|100|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5006|101|P|machinery, or do anything that needs alertness until you can do||
5006|102|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5006|103|P|are using marijuana (cannabis).||
5006|104|P|   Before having surgery, tell your doctor or dentist about all||
5006|105|P|the products you use (including prescription drugs,||
5006|106|P|nonprescription drugs, and herbal products).||
5006|107|P|   Older adults may be more sensitive to the side effects of this||
5006|108|P|drug, especially drowsiness.||
5006|109|P|   Tell your doctor if you are pregnant or plan to become||
5006|110|P|pregnant. You should not become pregnant while using bromazepam.||
5006|111|P|Bromazepam may harm an unborn baby. Newborn babies of mothers who||
5006|112|P|use this medication late in pregnancy may have symptoms such as||
5006|113|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
5006|114|P|feeding. If you become pregnant, talk to your doctor right away||
5006|115|P|about the risks and benefits of this medication.||
5006|116|P|   This medication passes into breast milk and may have||
5006|117|P|undesirable effects on a nursing infant. Breastfeeding is not||
5006|118|P|recommended while using this medication. Consult your doctor||
5006|119|P|before breastfeeding.||
5006|120|B|||
5006|121|I|DRUG INTERACTIONS:  See also Warning section.||
5006|122|I|   Drug interactions may change how your medications work or||
5006|123|I|increase your risk for serious side effects. This document does||
5006|124|I|not contain all possible drug interactions. Keep a list of all||
5006|125|I|the products you use (including prescription/nonprescription||
5006|126|I|drugs and herbal products) and share it with your doctor and||
5006|127|I|pharmacist. Do not start, stop, or change the dosage of any||
5006|128|I|medicines without your doctor's approval.||
5006|129|I|   The risk of serious side effects (such as slow/shallow||
5006|130|I|breathing, severe drowsiness/dizziness) may be increased if this||
5006|131|I|medication is taken with other products that may also cause||
5006|132|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5006|133|I|if you are taking other products such as opioid pain or cough||
5006|134|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5006|135|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
5006|136|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5006|137|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5006|138|I|diphenhydramine).||
5006|139|I|   Check the labels on all your medicines (such as allergy or||
5006|140|I|cough-and-cold products) because they may contain ingredients||
5006|141|I|that cause drowsiness. Ask your pharmacist about using those||
5006|142|I|products safely.||
5006|143|B|||
5006|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5006|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5006|146|O|poison control center right away. US residents can call||
5006|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5006|148|O|Symptoms of overdose may include: slow/shallow breathing, severe||
5006|149|O|dizziness/drowsiness, loss of consciousness.||
5006|150|B|||
5006|151|N|NOTES:  Do not share this medication with others. Sharing it is||
5006|152|N|against the law.||
5006|153|N|   Lab and/or medical tests (such as complete blood count, liver||
5006|154|N|function) may be done while you are taking this medication. Keep||
5006|155|N|all medical and lab appointments. Consult your doctor for more||
5006|156|N|details.||
5006|157|B|||
5006|158|D|MISSED DOSE:  If you take this medication regularly and miss a||
5006|159|D|dose, take it as soon as you remember. If it is near the time of||
5006|160|D|the next dose, skip the missed dose. Take your next dose at the||
5006|161|D|regular time. Do not double the dose to catch up.||
5006|162|B|||
5006|163|R|STORAGE:  Store at room temperature away from light and moisture.||
5006|164|R|Do not store in the bathroom. Keep all medications away from||
5006|165|R|children and pets.||
5006|166|R|   Do not flush medications down the toilet or pour them into a||
5006|167|R|drain unless instructed to do so. Properly discard this product||
5006|168|R|when it is expired or no longer needed. Consult your pharmacist||
5006|169|R|or local waste disposal company.||
5006|170|B|||
5006|171|A|Information last revised May 2024.||
5006|172|A|Copyright(c) 2025 First Databank, Inc.||
5006|173|B|||
5007|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5007|002|Z|does NOT have all possible information about this product. This||
5007|003|Z|information does not assure that this product is safe, effective,||
5007|004|Z|or appropriate for you. This information is not individual||
5007|005|Z|medical advice and does not substitute for the advice of your||
5007|006|Z|health care professional. Always ask your health care||
5007|007|Z|professional for complete information about this product and your||
5007|008|Z|specific health needs.||
5007|009|B|||
5007|010|T|PRAMIPEXOLE - ORAL||
5007|011|F|(pram-ih-PEX-ole)||
5007|012|B|||
5007|013|C|COMMON BRAND NAME(S): Mirapex||
5007|014|B|||
5007|015|U|USES:  Pramipexole is used alone or with other medications to||
5007|016|U|treat Parkinson's disease. It can improve your ability to move||
5007|017|U|and decrease shakiness (tremor), stiffness, slowed movement, and||
5007|018|U|unsteadiness. It may also decrease the number of episodes of not||
5007|019|U|being able to move ("on-off syndrome").||
5007|020|U|   This medication is also used to treat a certain medical||
5007|021|U|condition (restless legs syndrome - RLS) that causes an unusual||
5007|022|U|urge to move the legs. Symptoms usually occur at night along with||
5007|023|U|uncomfortable/unpleasant feelings in the legs. This medication||
5007|024|U|can decrease these symptoms and thereby improve sleep.||
5007|025|U|   Pramipexole is a dopamine agonist that works by helping to||
5007|026|U|restore the balance of a certain natural substance (dopamine) in||
5007|027|U|the brain.||
5007|028|B|||
5007|029|V|OTHER USES:  This section contains uses of this drug that are not||
5007|030|V|listed in the approved professional labeling for the drug but||
5007|031|V|that may be prescribed by your health care professional. Use this||
5007|032|V|drug for a condition that is listed in this section only if it||
5007|033|V|has been so prescribed by your health care professional.||
5007|034|V|   This medication may also be used for a certain painful||
5007|035|V|condition (fibromyalgia).||
5007|036|B|||
5007|037|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5007|038|H|from your pharmacist before you start taking pramipexole and each||
5007|039|H|time you get a refill. If you have any questions, ask your doctor||
5007|040|H|or pharmacist.||
5007|041|H|   Take this medication by mouth with or without food, as||
5007|042|H|directed by your doctor. Taking this medication with food may||
5007|043|H|lessen nausea. To reduce your risk of side effects (such as||
5007|044|H|drowsiness, low blood pressure), your doctor may direct you to||
5007|045|H|start this medication at a low dose and gradually increase your||
5007|046|H|dose. Follow your doctor's instructions carefully.||
5007|047|H|   The dosage is based on your medical condition and response to||
5007|048|H|treatment. Use this medication regularly to get the most benefit||
5007|049|H|from it. To help you remember, take it at the same time(s) each||
5007|050|H|day. Do not increase your dose or take it more often than||
5007|051|H|directed.||
5007|052|H|   Do not stop taking this medication without consulting your||
5007|053|H|doctor. Some conditions may become worse when this medication is||
5007|054|H|suddenly stopped. Also, if you suddenly stop using this||
5007|055|H|medication, you may have withdrawal symptoms (such as anxiety,||
5007|056|H|depression, confusion, fever, muscle stiffness). To help prevent||
5007|057|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
5007|058|H|more likely if you have used pramipexole for a long time or in||
5007|059|H|high doses. Tell your doctor or pharmacist right away if you have||
5007|060|H|withdrawal.||
5007|061|H|   If you temporarily stop taking this medication, you may need||
5007|062|H|to start this medication again at a low dose and gradually||
5007|063|H|increase your dose. Talk with your doctor about how to restart||
5007|064|H|this medication.||
5007|065|H|   It may take a few weeks for the effects of this medication to||
5007|066|H|be noticed. Tell your doctor if your condition does not get||
5007|067|H|better or if it gets worse.||
5007|068|B|||
5007|069|S|SIDE EFFECTS:  Nausea, dizziness, drowsiness, lightheadedness,||
5007|070|S|trouble sleeping, constipation, headache, or dry mouth may occur.||
5007|071|S|If these effects last or get worse, tell your doctor or||
5007|072|S|pharmacist promptly.||
5007|073|S|   To reduce the risk of dizziness and lightheadedness, get up||
5007|074|S|slowly when rising from a sitting or lying position.||
5007|075|S|   Remember that this medication has been prescribed because your||
5007|076|S|doctor has judged that the benefit to you is greater than the||
5007|077|S|risk of side effects. Many people using this medication do not||
5007|078|S|have serious side effects.||
5007|079|S|   Tell your doctor right away if you have any serious side||
5007|080|S|effects, including: fainting, mental/mood changes (such as||
5007|081|S|confusion, agitation, hallucinations), unusual strong urges (such||
5007|082|S|as increased gambling, increased sexual urges), increased||
5007|083|S|difficulty moving/walking, muscle cramps/spasm, unusual posture||
5007|084|S|changes (such as the neck or body bending forward), restlessness,||
5007|085|S|decreased sexual ability, increased shakiness (tremor)/stiffness,||
5007|086|S|swelling of the ankles/feet.||
5007|087|S|   Get medical help right away if you have any very serious side||
5007|088|S|effects, including: chest pain, fever, unusually||
5007|089|S|fast/slow/irregular heartbeat, muscle pain/weakness, unusual||
5007|090|S|tiredness, signs of kidney problems (such as change in the amount||
5007|091|S|of urine), vision changes.||
5007|092|S|   Some people taking pramipexole have fallen asleep suddenly||
5007|093|S|during their usual daily activities (such as talking on the||
5007|094|S|phone, driving). In some cases, sleep occurred without any||
5007|095|S|feelings of drowsiness beforehand. This sleep effect may occur||
5007|096|S|anytime during treatment with pramipexole even if you have used||
5007|097|S|this medication for a long time. If you experience increased||
5007|098|S|sleepiness or fall asleep during the day, do not drive or take||
5007|099|S|part in other possibly dangerous activities until you have||
5007|100|S|discussed this effect with your doctor. Your risk of this sleep||
5007|101|S|effect is increased by using alcohol or other medications that||
5007|102|S|can make you drowsy. See also Precautions section.||
5007|103|S|   A very serious allergic reaction to this drug is rare.||
5007|104|S|However, get medical help right away if you notice any symptoms||
5007|105|S|of a serious allergic reaction, including: rash, itching/swelling||
5007|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5007|107|S|breathing.||
5007|108|S|   This is not a complete list of possible side effects. If you||
5007|109|S|notice other effects not listed above, contact your doctor or||
5007|110|S|pharmacist.||
5007|111|S|   In the US -||
5007|112|S|   Call your doctor for medical advice about side effects. You||
5007|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5007|114|S|www.fda.gov/medwatch.||
5007|115|S|   In Canada - Call your doctor for medical advice about side||
5007|116|S|effects. You may report side effects to Health Canada at||
5007|117|S|1-866-234-2345.||
5007|118|B|||
5007|119|P|PRECAUTIONS:  Before taking pramipexole, tell your doctor or||
5007|120|P|pharmacist if you are allergic to it; or if you have any other||
5007|121|P|allergies. This product may contain inactive ingredients, which||
5007|122|P|can cause allergic reactions or other problems. Talk to your||
5007|123|P|pharmacist for more details.||
5007|124|P|   Before using this medication, tell your doctor or pharmacist||
5007|125|P|your medical history, especially of: low blood pressure, heart||
5007|126|P|problems (such as irregular heartbeat, heart failure), kidney||
5007|127|P|problems, mental/mood disorders (such as confusion,||
5007|128|P|hallucinations, psychosis, schizophrenia), sleep disorder (such||
5007|129|P|as sleep apnea, narcolepsy).||
5007|130|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5007|131|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5007|132|P|machinery, or do anything that needs alertness until you can do||
5007|133|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5007|134|P|are using marijuana (cannabis). See also Side Effects section.||
5007|135|P|   Before having surgery, tell your doctor or dentist about all||
5007|136|P|the products you use (including prescription drugs,||
5007|137|P|nonprescription drugs, and herbal products).||
5007|138|P|   Older adults may be at a greater risk for dizziness and||
5007|139|P|hallucinations while using this drug.||
5007|140|P|   During pregnancy, this medication should be used only when||
5007|141|P|clearly needed. Discuss the risks and benefits with your doctor.||
5007|142|P|   It is unknown if this medication passes into breast milk.||
5007|143|P|Consult your doctor before breastfeeding.||
5007|144|B|||
5007|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5007|146|I|medications work or increase your risk for serious side effects.||
5007|147|I|This document does not contain all possible drug interactions.||
5007|148|I|Keep a list of all the products you use (including||
5007|149|I|prescription/nonprescription drugs and herbal products) and share||
5007|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
5007|151|I|the dosage of any medicines without your doctor's approval.||
5007|152|I|   Some products that may interact with this drug include:||
5007|153|I|antipsychotics (such as chlorpromazine, haloperidol,||
5007|154|I|thiothixene), cimetidine, metoclopramide.||
5007|155|I|   Tell your doctor or pharmacist if you are taking other||
5007|156|I|products that cause drowsiness including alcohol, marijuana||
5007|157|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
5007|158|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
5007|159|I|zolpidem), muscle relaxants (such as carisoprodol,||
5007|160|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
5007|161|I|hydrocodone).||
5007|162|I|   Check the labels on all your medicines (such as allergy or||
5007|163|I|cough-and-cold products) because they may contain ingredients||
5007|164|I|that cause drowsiness. Ask your pharmacist about using those||
5007|165|I|products safely.||
5007|166|B|||
5007|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5007|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5007|169|O|poison control center right away. US residents can call||
5007|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5007|171|B|||
5007|172|N|NOTES:  Do not share this medication with others.||
5007|173|B|||
5007|174|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5007|175|D|remember. If it is near the time of the next dose, skip the||
5007|176|D|missed dose. Take your next dose at the regular time. Do not||
5007|177|D|double the dose to catch up.||
5007|178|B|||
5007|179|R|STORAGE:  Store at room temperature away from light and moisture.||
5007|180|R|Do not store in the bathroom. Keep all medications away from||
5007|181|R|children and pets.||
5007|182|R|   Do not flush medications down the toilet or pour them into a||
5007|183|R|drain unless instructed to do so. Properly discard this product||
5007|184|R|when it is expired or no longer needed. Consult your pharmacist||
5007|185|R|or local waste disposal company.||
5007|186|B|||
5007|187|A|Information last revised October 2024.||
5007|188|A|Copyright(c) 2025 First Databank, Inc.||
5007|189|B|||
5011|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5011|002|Z|does NOT have all possible information about this product. This||
5011|003|Z|information does not assure that this product is safe, effective,||
5011|004|Z|or appropriate for you. This information is not individual||
5011|005|Z|medical advice and does not substitute for the advice of your||
5011|006|Z|health care professional. Always ask your health care||
5011|007|Z|professional for complete information about this product and your||
5011|008|Z|specific health needs.||
5011|009|B|||
5011|010|T|CEFPODOXIME PROXETIL - ORAL||
5011|011|F|(seff-poh-DOX-eem PROX-eh-til)||
5011|012|B|||
5011|013|C|COMMON BRAND NAME(S): Vantin||
5011|014|B|||
5011|015|U|USES:  This medication is used to treat a wide variety of||
5011|016|U|bacterial infections. This medication is known as a cephalosporin||
5011|017|U|antibiotic. It works by stopping the growth of bacteria.||
5011|018|U|   This antibiotic treats only bacterial infections. It will not||
5011|019|U|work for viral infections (such as common cold, flu). Using any||
5011|020|U|antibiotic when it is not needed can cause it to not work for||
5011|021|U|future infections.||
5011|022|B|||
5011|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
5011|024|H|doctor, usually every 12 hours.||
5011|025|H|   If you are using the tablet form of this medication, take it||
5011|026|H|with food to help increase the absorption of the drug.||
5011|027|H|   If you are using the suspension form of this medication, take||
5011|028|H|it with or without food. Shake the bottle well before each dose.||
5011|029|H|   The dosage is based on your medical condition and response to||
5011|030|H|treatment. Children's dosage is also based on weight.||
5011|031|H|   Medications that reduce stomach acid (such as antacids, proton||
5011|032|H|pump inhibitors/PPIs, H2 blockers) may make cefpodoxime work less||
5011|033|H|well. Ask your doctor or pharmacist for more details.||
5011|034|H|   For the best effect, take this antibiotic at evenly spaced||
5011|035|H|times. To help you remember, take this medication at the same||
5011|036|H|time(s) every day.||
5011|037|H|   Continue to take this medication until the full prescribed||
5011|038|H|amount is finished, even if symptoms disappear after a few days.||
5011|039|H|Stopping the medication too early may result in a return of the||
5011|040|H|infection.||
5011|041|H|   Tell your doctor if your condition lasts or gets worse.||
5011|042|B|||
5011|043|S|SIDE EFFECTS:  Diarrhea, nausea/vomiting, or headache may occur.||
5011|044|S|If any of these effects last or get worse, tell your doctor or||
5011|045|S|pharmacist promptly.||
5011|046|S|   Remember that this medication has been prescribed because your||
5011|047|S|doctor has judged that the benefit to you is greater than the||
5011|048|S|risk of side effects. Many people using this medication do not||
5011|049|S|have serious side effects.||
5011|050|S|   Tell your doctor right away if you have any serious side||
5011|051|S|effects, including: nausea/vomiting that doesn't stop, swelling||
5011|052|S|of the ankles/feet, tiredness, fast/pounding heartbeat, trouble||
5011|053|S|breathing, new signs of infection (such as sore throat that||
5011|054|S|doesn't go away, fever, chills), dark urine, yellowing eyes/skin,||
5011|055|S|easy bruising/bleeding, signs of kidney problems (such as change||
5011|056|S|in the amount of urine).||
5011|057|S|   Get medical help right away if you have any very serious side||
5011|058|S|effects, including: vision changes, trouble speaking, mental/mood||
5011|059|S|changes (such as confusion).||
5011|060|S|   This medication may rarely cause a severe intestinal condition||
5011|061|S|due to a bacteria called C. difficile. This condition may occur||
5011|062|S|during treatment or weeks to months after treatment has stopped.||
5011|063|S|Tell your doctor right away if you develop: diarrhea that doesn't||
5011|064|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
5011|065|S|stool.||
5011|066|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
5011|067|S|products because they may make symptoms worse.||
5011|068|S|   Use of this medication for prolonged or repeated periods may||
5011|069|S|result in oral thrush or a new vaginal yeast infection. Contact||
5011|070|S|your doctor if you notice white patches in your mouth, a change||
5011|071|S|in vaginal discharge, or other new symptoms.||
5011|072|S|   A very serious allergic reaction to this drug is rare.||
5011|073|S|However, get medical help right away if you notice any symptoms||
5011|074|S|of a serious allergic reaction, including: rash, itching/swelling||
5011|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5011|076|S|breathing.||
5011|077|S|   This is not a complete list of possible side effects. If you||
5011|078|S|notice other effects not listed above, contact your doctor or||
5011|079|S|pharmacist.||
5011|080|S|   In the US -||
5011|081|S|   Call your doctor for medical advice about side effects. You||
5011|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5011|083|S|www.fda.gov/medwatch.||
5011|084|S|   In Canada - Call your doctor for medical advice about side||
5011|085|S|effects. You may report side effects to Health Canada at||
5011|086|S|1-866-234-2345.||
5011|087|B|||
5011|088|P|PRECAUTIONS:  Before taking cefpodoxime proxetil, tell your||
5011|089|P|doctor or pharmacist if you are allergic to it; or to penicillins||
5011|090|P|or other cephalosporin antibiotics (such as cephalexin); or if||
5011|091|P|you have any other allergies. This product may contain inactive||
5011|092|P|ingredients, which can cause allergic reactions or other||
5011|093|P|problems. Talk to your pharmacist for more details.||
5011|094|P|   Before using this medication, tell your doctor or pharmacist||
5011|095|P|your medical history, especially of: kidney disease,||
5011|096|P|stomach/intestinal disease (such as colitis).||
5011|097|P|   This medication may cause live bacterial vaccines (such as||
5011|098|P|typhoid vaccine) to not work well. Tell your health care||
5011|099|P|professional that you are using this medication before having any||
5011|100|P|immunizations/vaccinations.||
5011|101|P|   Older adults may be at greater risk for side effects while||
5011|102|P|using this drug.||
5011|103|P|   During pregnancy, this medication should be used only when||
5011|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
5011|105|P|   This drug passes into breast milk and could have undesirable||
5011|106|P|effects on a nursing infant. Consult your doctor before||
5011|107|P|breastfeeding.||
5011|108|B|||
5011|109|I|DRUG INTERACTIONS:  See also How To Use section.||
5011|110|I|   Drug interactions may change how your medications work or||
5011|111|I|increase your risk for serious side effects. This document does||
5011|112|I|not contain all possible drug interactions. Keep a list of all||
5011|113|I|the products you use (including prescription/nonprescription||
5011|114|I|drugs and herbal products) and share it with your doctor and||
5011|115|I|pharmacist. Do not start, stop, or change the dosage of any||
5011|116|I|medicines without your doctor's approval.||
5011|117|I|   This medication may interfere with certain lab tests (such as||
5011|118|I|Coombs' test, certain urine glucose tests), possibly causing||
5011|119|I|false test results. Make sure lab personnel and all your doctors||
5011|120|I|know you use this drug.||
5011|121|B|||
5011|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5011|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5011|124|O|poison control center right away. US residents can call||
5011|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5011|126|B|||
5011|127|N|NOTES:  Do not share this medication with others.||
5011|128|N|   This medication has been prescribed for your current condition||
5011|129|N|only. Do not use it later for another infection unless your||
5011|130|N|doctor tells you to.||
5011|131|B|||
5011|132|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5011|133|D|remember. If it is near the time of the next dose, skip the||
5011|134|D|missed dose. Take your next dose at the regular time. Do not||
5011|135|D|double the dose to catch up.||
5011|136|B|||
5011|137|R|STORAGE:  Store the tablets at room temperature away from light||
5011|138|R|and moisture. Do not store in the bathroom. Store the suspension||
5011|139|R|in the refrigerator. Do not freeze. Discard any unused suspension||
5011|140|R|after 14 day. Keep all medications away from children and pets.||
5011|141|R|   Do not flush medications down the toilet or pour them into a||
5011|142|R|drain unless instructed to do so. Properly discard this product||
5011|143|R|when it is expired or no longer needed. Consult your pharmacist||
5011|144|R|or local waste disposal company.||
5011|145|B|||
5011|146|A|Information last revised June 2025.||
5011|147|A|Copyright(c) 2025 First Databank, Inc.||
5011|148|B|||
5013|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5013|002|Z|does NOT have all possible information about this product. This||
5013|003|Z|information does not assure that this product is safe, effective,||
5013|004|Z|or appropriate for you. This information is not individual||
5013|005|Z|medical advice and does not substitute for the advice of your||
5013|006|Z|health care professional. Always ask your health care||
5013|007|Z|professional for complete information about this product and your||
5013|008|Z|specific health needs.||
5013|009|B|||
5013|010|T|CARTEOLOL SOLUTION - OPHTHALMIC||
5013|011|F|(kar-TEE-oh-lol)||
5013|012|B|||
5013|013|C|COMMON BRAND NAME(S): Ocupress||
5013|014|B|||
5013|015|U|USES:  Carteolol is used alone or with other medications to treat||
5013|016|U|high pressure inside the eye due to glaucoma (open-angle type) or||
5013|017|U|other eye diseases (such as ocular hypertension). Lowering high||
5013|018|U|pressure inside the eye helps to prevent blindness. Carteolol is||
5013|019|U|a beta blocker. It is thought to work by reducing the amount of||
5013|020|U|fluid made in the eye.||
5013|021|B|||
5013|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
5013|023|H|directed by your doctor, usually twice daily. Use in the eye||
5013|024|H|only. Do not swallow or inject.||
5013|025|H|   Dosage is based on your medical condition and response to||
5013|026|H|treatment. Follow your doctor's directions on how to use this||
5013|027|H|medication.||
5013|028|H|   To apply eye drops, wash your hands first. To avoid||
5013|029|H|contamination, do not touch the dropper tip or let it touch your||
5013|030|H|eye or any other surface.||
5013|031|H|   Before using, check this product for cloudiness, particles, or||
5013|032|H|brown discoloration. If you see any of these things, do not use||
5013|033|H|the liquid.||
5013|034|H|   The preservative in this product may be absorbed by contact||
5013|035|H|lenses. If you wear contact lenses, remove them before using your||
5013|036|H|eye drops. Wait at least 15 minutes after using this medication||
5013|037|H|before putting your contact lenses back in.||
5013|038|H|   Tilt your head back, look upward, and pull down the lower||
5013|039|H|eyelid to make a pouch. Hold the dropper directly over the eye||
5013|040|H|and place one drop in the pouch. Look downward and gently close||
5013|041|H|your eyes for 1-2 minutes. Place one finger at the corner of the||
5013|042|H|eye near the nose and apply gentle pressure. This will prevent||
5013|043|H|the medication from draining out. Try not to blink and do not rub||
5013|044|H|the eye. Repeat these steps for your other eye if directed by||
5013|045|H|your doctor.||
5013|046|H|   Do not rinse the dropper. Replace the dropper cap after each||
5013|047|H|use.||
5013|048|H|   If you are using another kind of eye medication (such as drops||
5013|049|H|or ointments), wait at least 10 minutes before applying other||
5013|050|H|medications. Use the eye drops before eye ointments to allow the||
5013|051|H|eye drops to enter the eye.||
5013|052|H|   Wait several minutes for your vision to clear before driving||
5013|053|H|or operating machinery.||
5013|054|H|   Use this medication regularly in order to get the most benefit||
5013|055|H|from it. To help you remember, use it at the same times each day.||
5013|056|H|Keep using this medication even if you feel well. Most people||
5013|057|H|with high pressure in the eye do not feel sick.||
5013|058|B|||
5013|059|S|SIDE EFFECTS:  Temporary blurred vision or temporary||
5013|060|S|burning/stinging/itching/redness of the eye may occur. If any of||
5013|061|S|these effects last or get worse, tell your doctor or pharmacist||
5013|062|S|promptly.||
5013|063|S|   Remember that this medication has been prescribed because your||
5013|064|S|doctor has judged that the benefit to you is greater than the||
5013|065|S|risk of side effects. Many people using this medication do not||
5013|066|S|have serious side effects.||
5013|067|S|   Tell your doctor right away if you have any serious side||
5013|068|S|effects, including: eye pain/swelling/discharge, eye sensitivity||
5013|069|S|to light, mental/mood changes (such as depression), new or||
5013|070|S|worsening symptoms of heart failure (such as swelling||
5013|071|S|ankles/feet, unusual tiredness, unusual/sudden weight gain),||
5013|072|S|slow/irregular heartbeat, dizziness.||
5013|073|S|   Get medical help right away if you have any very serious side||
5013|074|S|effects, including: wheezing/difficulty breathing, chest pain,||
5013|075|S|fainting, weakness on one side of the body, trouble speaking,||
5013|076|S|seizures, confusion, sudden vision changes.||
5013|077|S|   A very serious allergic reaction to this drug is rare.||
5013|078|S|However, get medical help right away if you notice any symptoms||
5013|079|S|of a serious allergic reaction, including: rash, itching/swelling||
5013|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5013|081|S|breathing.||
5013|082|S|   This is not a complete list of possible side effects. If you||
5013|083|S|notice other effects not listed above, contact your doctor or||
5013|084|S|pharmacist.||
5013|085|S|   In the US -||
5013|086|S|   Call your doctor for medical advice about side effects. You||
5013|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5013|088|S|www.fda.gov/medwatch.||
5013|089|S|   In Canada - Call your doctor for medical advice about side||
5013|090|S|effects. You may report side effects to Health Canada at||
5013|091|S|1-866-234-2345.||
5013|092|B|||
5013|093|P|PRECAUTIONS:  Before using carteolol, tell your doctor or||
5013|094|P|pharmacist if you are allergic to it; or to other beta blockers||
5013|095|P|(such as timolol); or if you have any other allergies. This||
5013|096|P|product may contain inactive ingredients (such as preservatives)||
5013|097|P|which can cause allergic reactions or other problems. Talk to||
5013|098|P|your pharmacist for more details.||
5013|099|P|   Before using this medication, tell your doctor or pharmacist||
5013|100|P|your medical history, especially of: lung disease/breathing||
5013|101|P|problems (such as asthma, chronic obstructive pulmonary||
5013|102|P|disease-COPD), slow/irregular heartbeat (such as bradycardia, AV||
5013|103|P|block), heart disease (such as chest pain, heart attack, heart||
5013|104|P|failure), diabetes, overactive thyroid (such as hyperthyroidism),||
5013|105|P|blood circulation problems (such as Raynaud's disease, peripheral||
5013|106|P|vascular disease), low blood flow to the brain (cerebral||
5013|107|P|insufficiency, stroke), mental/mood disorders (such as||
5013|108|P|depression), certain nerve/muscle problems (such as myasthenia||
5013|109|P|gravis), history of severe allergic reactions (such as||
5013|110|P|anaphylaxis, atopy).||
5013|111|P|   If you develop an eye infection or injury, or have eye||
5013|112|P|surgery, check with your doctor about whether you should continue||
5013|113|P|to use your current bottle of carteolol. You may be advised to||
5013|114|P|start using a new bottle.||
5013|115|P|   After you apply this drug, your vision may become temporarily||
5013|116|P|blurred. Do not drive, use machinery, or do anything that needs||
5013|117|P|clear vision until you can do it safely.||
5013|118|P|   Before having surgery, tell your doctor or dentist about all||
5013|119|P|the products you use (including prescription drugs,||
5013|120|P|nonprescription drugs, and herbal products).||
5013|121|P|   This product may prevent the fast/pounding heartbeat you would||
5013|122|P|usually feel when your blood sugar level falls too low||
5013|123|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
5013|124|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
5013|125|P|blood sugar level, such as dizziness and sweating, are not||
5013|126|P|affected by this drug.||
5013|127|P|   If you have diabetes, this product may make it harder to||
5013|128|P|control your blood sugar levels. Check your blood sugar levels||
5013|129|P|regularly as directed by your doctor. Tell your doctor right away||
5013|130|P|if you have symptoms of high blood sugar such as increased||
5013|131|P|thirst/urination. Your doctor may need to adjust your diabetes||
5013|132|P|medication, exercise program, or diet.||
5013|133|P|   During pregnancy, this medication should be used only when||
5013|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
5013|135|P|   It is unknown if this medication passes into breast milk.||
5013|136|P|Consult your doctor before breastfeeding.||
5013|137|B|||
5013|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5013|139|I|medications work or increase your risk for serious side effects.||
5013|140|I|This document does not contain all possible drug interactions.||
5013|141|I|Keep a list of all the products you use (including||
5013|142|I|prescription/nonprescription drugs and herbal products) and share||
5013|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
5013|144|I|the dosage of any medicines without your doctor's approval.||
5013|145|I|   Some products that may interact with this drug include: alpha||
5013|146|I|blockers (such as prazosin), beta blockers taken by mouth (such||
5013|147|I|as atenolol, metoprolol), clonidine, digoxin, epinephrine,||
5013|148|I|certain drugs for high blood pressure (such as methyldopa).||
5013|149|B|||
5013|150|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5013|151|O|has overdosed and has serious symptoms such as passing out or||
5013|152|O|trouble breathing, call 911. Otherwise, call a poison control||
5013|153|O|center right away. US residents can call 1-800-222-1222. Canada||
5013|154|O|residents can call 1-844-764-7669. Symptoms of overdose may||
5013|155|O|include: slow/irregular heart beat, dizziness, fainting,||
5013|156|O|difficulty breathing.||
5013|157|B|||
5013|158|N|NOTES:  Do not share this medication with others.||
5013|159|N|   Lab and/or medical tests (such as eye exams, heart rate)||
5013|160|N|should be done while you are using this medication. Keep all||
5013|161|N|medical and lab appointments. Consult your doctor for more||
5013|162|N|details.||
5013|163|B|||
5013|164|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5013|165|D|If it is near the time of the next dose, skip the missed dose.||
5013|166|D|Use your next dose at the regular time. Do not double the dose to||
5013|167|D|catch up.||
5013|168|B|||
5013|169|R|STORAGE:  Store at room temperature away from light. Do not||
5013|170|R|freeze. Keep all medications away from children and pets.||
5013|171|R|   Do not flush medications down the toilet or pour them into a||
5013|172|R|drain unless instructed to do so. Properly discard this product||
5013|173|R|when it is expired or no longer needed. Consult your pharmacist||
5013|174|R|or local waste disposal company.||
5013|175|B|||
5013|176|A|Information last revised November 2024.||
5013|177|A|Copyright(c) 2025 First Databank, Inc.||
5013|178|B|||
5015|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5015|002|Z|does NOT have all possible information about this product. This||
5015|003|Z|information does not assure that this product is safe, effective,||
5015|004|Z|or appropriate for you. This information is not individual||
5015|005|Z|medical advice and does not substitute for the advice of your||
5015|006|Z|health care professional. Always ask your health care||
5015|007|Z|professional for complete information about this product and your||
5015|008|Z|specific health needs.||
5015|009|B|||
5015|010|T|ERYTHROMYCIN DELAYED-RELEASE - ORAL||
5015|011|F|(e-RITH-roe-MYE-sin base)||
5015|012|B|||
5015|013|C|COMMON BRAND NAME(S): Ery-Tab, Eryc, PCE||
5015|014|B|||
5015|015|U|USES:  Erythromycin is used to treat a wide variety of bacterial||
5015|016|U|infections. It may also be used to prevent certain bacterial||
5015|017|U|infections. Erythromycin is known as a macrolide antibiotic. It||
5015|018|U|works by stopping the growth of bacteria.||
5015|019|U|   This antibiotic treats or prevents only bacterial infections.||
5015|020|U|It will not work for viral infections (such as common cold, flu).||
5015|021|U|Using any antibiotic when it is not needed can cause it to not||
5015|022|U|work for future infections.||
5015|023|B|||
5015|024|V|OTHER USES:  This section contains uses of this drug that are not||
5015|025|V|listed in the approved professional labeling for the drug but||
5015|026|V|that may be prescribed by your health care professional. Use this||
5015|027|V|drug for a condition that is listed in this section only if it||
5015|028|V|has been so prescribed by your health care professional.||
5015|029|V|   This drug may also be used for a certain type of stomach||
5015|030|V|condition involving slowed digestion (gastroparesis).||
5015|031|B|||
5015|032|H|HOW TO USE:  Take this medication by mouth as directed by your||
5015|033|H|doctor. This medication is best absorbed when taken on an empty||
5015|034|H|stomach. If nausea occurs, you may take it with food or milk.||
5015|035|H|Swallow the medication whole. Do not crush, chew, or break it.||
5015|036|H|   The dosage and length of treatment are based on your medical||
5015|037|H|condition and response to treatment. Children's dosage is also||
5015|038|H|based on age and weight.||
5015|039|H|   For the best effect, take this antibiotic at evenly spaced||
5015|040|H|times. To help you remember, take this medication at the same||
5015|041|H|time(s) every day.||
5015|042|H|   If you are using this medication to treat an infection,||
5015|043|H|continue to take this medication until the full prescribed amount||
5015|044|H|is finished, even if symptoms disappear after a few days.||
5015|045|H|Stopping the medication too early may result in a return of the||
5015|046|H|infection. Tell your doctor if your condition lasts or gets||
5015|047|H|worse.||
5015|048|H|   If you are taking this medication to prevent certain bacterial||
5015|049|H|infections, take it exactly as directed by your doctor. Do not||
5015|050|H|stop taking the medication without your doctor's approval.||
5015|051|B|||
5015|052|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach pain/cramping,||
5015|053|S|and loss of appetite may occur. Taking this medication with food||
5015|054|S|may lessen these symptoms. If any of these effects last or get||
5015|055|S|worse, tell your doctor or pharmacist promptly.||
5015|056|S|   Remember that this medication has been prescribed because your||
5015|057|S|doctor has judged that the benefit to you is greater than the||
5015|058|S|risk of side effects. Many people using this medication do not||
5015|059|S|have serious side effects.||
5015|060|S|   Tell your doctor right away if you have any serious side||
5015|061|S|effects, including: signs of liver disease (such as||
5015|062|S|nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
5015|063|S|urine, severe stomach/abdominal pain), unusual tiredness, muscle||
5015|064|S|weakness, trouble speaking, blurred vision, drooping eyelids,||
5015|065|S|hearing loss.||
5015|066|S|   Get medical help right away if you have any very serious side||
5015|067|S|effects, including: severe dizziness, fainting, fast/irregular||
5015|068|S|heartbeat.||
5015|069|S|   This medication may rarely cause a severe intestinal condition||
5015|070|S|due to a bacteria called C. difficile. This condition may occur||
5015|071|S|during treatment or weeks to months after treatment has stopped.||
5015|072|S|Tell your doctor right away if you develop: diarrhea that doesn't||
5015|073|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
5015|074|S|stool.||
5015|075|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
5015|076|S|products because they may make symptoms worse.||
5015|077|S|   Use of this medication for prolonged or repeated periods may||
5015|078|S|result in oral thrush or a new yeast infection. Contact your||
5015|079|S|doctor if you notice white patches in your mouth, a change in||
5015|080|S|vaginal discharge or other new symptoms.||
5015|081|S|   A very serious allergic reaction to this drug is rare.||
5015|082|S|However, get medical help right away if you notice any symptoms||
5015|083|S|of a serious allergic reaction, including: rash, itching/swelling||
5015|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5015|085|S|breathing.||
5015|086|S|   This is not a complete list of possible side effects. If you||
5015|087|S|notice other effects not listed above, contact your doctor or||
5015|088|S|pharmacist.||
5015|089|S|   In the US -||
5015|090|S|   Call your doctor for medical advice about side effects. You||
5015|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5015|092|S|www.fda.gov/medwatch.||
5015|093|S|   In Canada - Call your doctor for medical advice about side||
5015|094|S|effects. You may report side effects to Health Canada at||
5015|095|S|1-866-234-2345.||
5015|096|B|||
5015|097|P|PRECAUTIONS:  Before taking erythromycin, tell your doctor or||
5015|098|P|pharmacist if you are allergic to it; or to other macrolide||
5015|099|P|antibiotics (such as azithromycin, clarithromycin); or if you||
5015|100|P|have any other allergies. This product may contain inactive||
5015|101|P|ingredients, which can cause allergic reactions or other||
5015|102|P|problems. Talk to your pharmacist for more details.||
5015|103|P|   Before using this medication, tell your doctor or pharmacist||
5015|104|P|your medical history, especially of: liver disease, kidney||
5015|105|P|disease, a certain type of muscle disease (myasthenia gravis).||
5015|106|P|   Erythromycin may cause a condition that affects the heart||
5015|107|P|rhythm (QT prolongation). QT prolongation can rarely cause||
5015|108|P|serious (rarely fatal) fast/irregular heartbeat and other||
5015|109|P|symptoms (such as severe dizziness, fainting) that need medical||
5015|110|P|attention right away.||
5015|111|P|   The risk of QT prolongation may be increased if you have||
5015|112|P|certain medical conditions or are taking other drugs that may||
5015|113|P|cause QT prolongation. Before using erythromycin, tell your||
5015|114|P|doctor or pharmacist of all the drugs you take and if you have||
5015|115|P|any of the following conditions: certain heart problems (heart||
5015|116|P|failure, slow heartbeat, QT prolongation in the EKG), family||
5015|117|P|history of certain heart problems (QT prolongation in the EKG,||
5015|118|P|sudden cardiac death).||
5015|119|P|   Low levels of potassium or magnesium in the blood may also||
5015|120|P|increase your risk of QT prolongation. This risk may increase if||
5015|121|P|you use certain drugs (such as diuretics/"water pills") or if you||
5015|122|P|have conditions such as severe sweating, diarrhea, or vomiting.||
5015|123|P|Talk to your doctor about using erythromycin safely.||
5015|124|P|   Erythromycin may cause live bacterial vaccines (such as||
5015|125|P|typhoid vaccine) to not work well. Tell your health care||
5015|126|P|professional that you are using erythromycin before having any||
5015|127|P|immunizations/vaccinations.||
5015|128|P|   Before having surgery, tell your doctor or dentist about all||
5015|129|P|the products you use (including prescription drugs,||
5015|130|P|nonprescription drugs, and herbal products).||
5015|131|P|   Some erythromycin products may contain sodium. Ask your doctor||
5015|132|P|or pharmacist for more information if you are on a||
5015|133|P|salt-restricted diet or if you have a condition that could be||
5015|134|P|worsened by an increase in salt intake (such as heart failure).||
5015|135|P|   Older adults may be more sensitive to the side effects of this||
5015|136|P|drug, especially hearing loss and QT prolongation (see above).||
5015|137|P|   Tell your doctor if you are pregnant before using this||
5015|138|P|medication.||
5015|139|P|   This medication passes into breast milk. Consult your doctor||
5015|140|P|before breastfeeding.||
5015|141|B|||
5015|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5015|143|I|medications work or increase your risk for serious side effects.||
5015|144|I|This document does not contain all possible drug interactions.||
5015|145|I|Keep a list of all the products you use (including||
5015|146|I|prescription/nonprescription drugs and herbal products) and share||
5015|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
5015|148|I|the dosage of any medicines without your doctor's approval.||
5015|149|I|   A product that may interact with this drug is: digoxin.||
5015|150|I|   Many drugs besides erythromycin may affect the heart rhythm||
5015|151|I|(QT prolongation), including amiodarone, dofetilide, pimozide,||
5015|152|I|procainamide, propafenone, quinidine, sotalol, among others.||
5015|153|I|   Other medications can affect the removal of erythromycin from||
5015|154|I|your body, which may affect how erythromycin works. Examples||
5015|155|I|include azole antifungals (such as itraconazole, ketoconazole),||
5015|156|I|certain calcium channel blockers (such as diltiazem, verapamil),||
5015|157|I|certain anti-seizure medications (such as carbamazepine,||
5015|158|I|phenytoin), among others.||
5015|159|I|   Erythromycin can slow down the removal of other drugs from||
5015|160|I|your body, which may affect how they work. Examples of affected||
5015|161|I|drugs include bromocriptine, colchicine, certain benzodiazepines||
5015|162|I|(such as midazolam, triazolam), eletriptan, ergot alkaloids (such||
5015|163|I|as ergotamine, dihydroergotamine), certain drugs to treat||
5015|164|I|erectile dysfunction-ED or pulmonary hypertension (such as||
5015|165|I|sildenafil, tadalafil), certain "statin" drugs (such as||
5015|166|I|lovastatin, simvastatin), vinblastine, among others.||
5015|167|I|   This medication may interfere with certain lab tests (such as||
5015|168|I|urine tests), possibly causing false test results. Make sure lab||
5015|169|I|personnel and all your doctors know you use this drug.||
5015|170|B|||
5015|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5015|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5015|173|O|poison control center right away. US residents can call||
5015|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5015|175|B|||
5015|176|N|NOTES:  Do not share this medication with others.||
5015|177|N|   This medication has been prescribed for your current condition||
5015|178|N|only. Do not use it later for another infection unless your||
5015|179|N|doctor tells you to.||
5015|180|B|||
5015|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5015|182|D|remember. If it is near the time of the next dose, skip the||
5015|183|D|missed dose. Take your next dose at the regular time. Do not||
5015|184|D|double the dose to catch up.||
5015|185|B|||
5015|186|R|STORAGE:  Store at room temperature away from light and moisture.||
5015|187|R|Do not store in the bathroom. Keep all medications away from||
5015|188|R|children and pets.||
5015|189|R|   Do not flush medications down the toilet or pour them into a||
5015|190|R|drain unless instructed to do so. Properly discard this product||
5015|191|R|when it is expired or no longer needed. Consult your pharmacist||
5015|192|R|or local waste disposal company.||
5015|193|B|||
5015|194|A|Information last revised July 2025.||
5015|195|A|Copyright(c) 2025 First Databank, Inc.||
5015|196|B|||
5016|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5016|002|Z|does NOT have all possible information about this product. This||
5016|003|Z|information does not assure that this product is safe, effective,||
5016|004|Z|or appropriate for you. This information is not individual||
5016|005|Z|medical advice and does not substitute for the advice of your||
5016|006|Z|health care professional. Always ask your health care||
5016|007|Z|professional for complete information about this product and your||
5016|008|Z|specific health needs.||
5016|009|B|||
5016|010|T|CLINDAMYCIN SUPPOSITORY - VAGINAL||
5016|011|F|(KLIN-da-MYE-sin)||
5016|012|B|||
5016|013|C|COMMON BRAND NAME(S): Cleocin||
5016|014|B|||
5016|015|U|USES:  This medication is used to treat a certain type of vaginal||
5016|016|U|infection (bacterial vaginosis) in women who are not pregnant.||
5016|017|U|Clindamycin is an antibiotic which works by stopping the growth||
5016|018|U|of bacteria.||
5016|019|B|||
5016|020|H|HOW TO USE:  Read the Patient Information Leaflet for||
5016|021|H|instructions on the proper use of this medication. Consult your||
5016|022|H|doctor or pharmacist if you have any questions.||
5016|023|H|   This product is for vaginal use only. Unwrap the suppository||
5016|024|H|and place it in the applicator. Insert the applicator high into||
5016|025|H|the vagina and press the plunger to release the medication. Use||
5016|026|H|this product as directed by your doctor, usually once a day at||
5016|027|H|bedtime for 3 days. Clean the applicator with warm soapy water||
5016|028|H|and rinse well. Do not boil or use hot water to clean the||
5016|029|H|applicator. You may also insert the suppository into the vagina||
5016|030|H|without using the applicator. Ask your doctor or pharmacist for||
5016|031|H|instructions.||
5016|032|H|   To prevent medication from leaking out of the vagina, lie down||
5016|033|H|as soon as possible after use.||
5016|034|H|   Antibiotics work best when the amount of medicine in your body||
5016|035|H|is kept at a constant level. Use this drug at evenly spaced||
5016|036|H|intervals.||
5016|037|H|   Continue to use this medication for the full time prescribed,||
5016|038|H|even if symptoms disappear after a few days. Stopping the||
5016|039|H|medication too early may result in a return of the infection.||
5016|040|H|   Tell your doctor if your condition lasts or gets worse.||
5016|041|B|||
5016|042|S|SIDE EFFECTS:  Mild diarrhea or stomach upset may occur. If any||
5016|043|S|of these effects last or get worse, tell your doctor or||
5016|044|S|pharmacist promptly.||
5016|045|S|   Although unlikely, vaginal pain/itching/discharge may occur or||
5016|046|S|worsen. These symptoms may be due to a new vaginal infection||
5016|047|S|(such as a yeast/fungal infection, trichomonas infection). This||
5016|048|S|medication may rarely cause a fungal infection in another part of||
5016|049|S|your body (such as oral thrush). Contact your doctor if you||
5016|050|S|notice a change in vaginal discharge, white patches in your||
5016|051|S|mouth, or other new symptoms.||
5016|052|S|   Remember that this medication has been prescribed because your||
5016|053|S|doctor has judged that the benefit to you is greater than the||
5016|054|S|risk of side effects. Many people using this medication do not||
5016|055|S|have serious side effects.||
5016|056|S|   Tell your doctor right away if you have any serious side||
5016|057|S|effects, including: pain when you urinate, lower back pain,||
5016|058|S|menstrual problems, abnormal vaginal bleeding.||
5016|059|S|   A very small amount of this medication may be absorbed into||
5016|060|S|your blood and may rarely cause a severe intestinal condition due||
5016|061|S|to a bacteria called C. difficile. This condition may occur||
5016|062|S|during treatment or weeks to months after treatment has stopped.||
5016|063|S|Tell your doctor right away if you develop: diarrhea that doesn't||
5016|064|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
5016|065|S|stool.||
5016|066|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
5016|067|S|products because they may make symptoms worse.||
5016|068|S|   A very serious allergic reaction to this drug is rare.||
5016|069|S|However, get medical help right away if you notice any symptoms||
5016|070|S|of a serious allergic reaction, including: rash, itching/swelling||
5016|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5016|072|S|breathing.||
5016|073|S|   This is not a complete list of possible side effects. If you||
5016|074|S|notice other effects not listed above, contact your doctor or||
5016|075|S|pharmacist.||
5016|076|S|   In the US -||
5016|077|S|   Call your doctor for medical advice about side effects. You||
5016|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5016|079|S|www.fda.gov/medwatch.||
5016|080|S|   In Canada - Call your doctor for medical advice about side||
5016|081|S|effects. You may report side effects to Health Canada at||
5016|082|S|1-866-234-2345.||
5016|083|B|||
5016|084|P|PRECAUTIONS:  Before using clindamycin, tell your doctor or||
5016|085|P|pharmacist if you are allergic to it; or to lincomycin; or if you||
5016|086|P|have any other allergies. This product may contain inactive||
5016|087|P|ingredients, which can cause allergic reactions or other||
5016|088|P|problems. Talk to your pharmacist for more details.||
5016|089|P|   Before using this medication, tell your doctor or pharmacist||
5016|090|P|your medical history, especially of: intestinal diseases (such as||
5016|091|P|C. difficile-associated diarrhea, enteritis, ulcerative colitis).||
5016|092|P|   Do not have vaginal intercourse or use tampons or douches||
5016|093|P|while using this medication because they can cause the||
5016|094|P|suppositories to not work as well.||
5016|095|P|   This product can weaken rubber products such as latex condoms||
5016|096|P|and diaphragms and lead to their failure. Do not use these||
5016|097|P|products during treatment with this medication and for 72 hours||
5016|098|P|after treatment is over. Consult your doctor about other forms of||
5016|099|P|barrier protection/birth control (such as polyurethane condoms)||
5016|100|P|during this time.||
5016|101|P|   During pregnancy, this medication should be used only when||
5016|102|P|clearly needed. Oral antibiotics have been used to treat vaginal||
5016|103|P|infections during pregnancy, especially high-risk pregnancies||
5016|104|P|(such as pregnancies with a risk of early childbirth). Consult||
5016|105|P|your doctor for more details and to discuss the risks and||
5016|106|P|benefits.||
5016|107|P|   It is unknown if the medication in this product passes into||
5016|108|P|breast milk. Consult your doctor before breastfeeding.||
5016|109|B|||
5016|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5016|111|I|medications work or increase your risk for serious side effects.||
5016|112|I|This document does not contain all possible drug interactions.||
5016|113|I|Keep a list of all the products you use (including||
5016|114|I|prescription/nonprescription drugs and herbal products) and share||
5016|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
5016|116|I|the dosage of any medicines without your doctor's approval.||
5016|117|B|||
5016|118|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5016|119|O|has overdosed and has serious symptoms such as passing out or||
5016|120|O|trouble breathing, call 911. Otherwise, call a poison control||
5016|121|O|center right away. US residents can call 1-800-222-1222. Canada||
5016|122|O|residents can call 1-844-764-7669.||
5016|123|B|||
5016|124|N|NOTES:  Do not share this medication with others.||
5016|125|N|   This medication has been prescribed for your current condition||
5016|126|N|only. Do not use it later for another infection unless your||
5016|127|N|doctor tells you to.||
5016|128|B|||
5016|129|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5016|130|D|If it is near the time of the next dose, skip the missed dose.||
5016|131|D|Use your next dose at the regular time. Do not double the dose to||
5016|132|D|catch up.||
5016|133|B|||
5016|134|R|STORAGE:  Store at room temperature away from moisture. Do not||
5016|135|R|store in the bathroom. Keep all medications away from children||
5016|136|R|and pets.||
5016|137|R|   Do not flush medications down the toilet or pour them into a||
5016|138|R|drain unless instructed to do so. Properly discard this product||
5016|139|R|when it is expired or no longer needed. Consult your pharmacist||
5016|140|R|or local waste disposal company.||
5016|141|B|||
5016|142|A|Information last revised January 2025.||
5016|143|A|Copyright(c) 2025 First Databank, Inc.||
5016|144|B|||
5017|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5017|002|Z|does NOT have all possible information about this product. This||
5017|003|Z|information does not assure that this product is safe, effective,||
5017|004|Z|or appropriate for you. This information is not individual||
5017|005|Z|medical advice and does not substitute for the advice of your||
5017|006|Z|health care professional. Always ask your health care||
5017|007|Z|professional for complete information about this product and your||
5017|008|Z|specific health needs.||
5017|009|B|||
5017|010|T|FOLLITROPIN ALFA - INJECTION||
5017|011|F|(FOL-i-TROE-pin AL-fa)||
5017|012|B|||
5017|013|C|COMMON BRAND NAME(S): Gonal-F RFF||
5017|014|B|||
5017|015|U|USES:  This medication contains follicle-stimulating hormone||
5017|016|U|(FSH) and is used to treat certain fertility problems in women.||
5017|017|U|Follitropin alfa helps stimulate healthy ovaries to produce eggs.||
5017|018|U|This medication is usually used in combination with another||
5017|019|U|hormone (hCG) to bring about the growth and release of a mature||
5017|020|U|egg (ovulation).||
5017|021|U|   This medication is not recommended for women whose ovaries no||
5017|022|U|longer make eggs properly (primary ovarian failure).||
5017|023|B|||
5017|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
5017|025|H|Instructions for Use if available from your pharmacist before you||
5017|026|H|start using follitropin alfa and each time you get a refill. Ask||
5017|027|H|your health care professional how to prepare and use this||
5017|028|H|medication. If you have any questions, ask your doctor or||
5017|029|H|pharmacist.||
5017|030|H|   Inject this medication under the skin or into a muscle as||
5017|031|H|directed by your doctor, usually once a day. The injection is||
5017|032|H|given in the upper arms, thighs, or abdomen. Your doctor may||
5017|033|H|direct you to use this medication in a treatment cycle (for||
5017|034|H|example, only on certain days each month). The dosage is based on||
5017|035|H|your medical condition, response to treatment, and labs.||
5017|036|H|   Once mixed, use the liquid right away. Do not shake the vial.||
5017|037|H|Before using, check this product for particles or discoloration.||
5017|038|H|If either is present, do not use the liquid. Before injecting||
5017|039|H|each dose, clean the skin you are going to inject into (the||
5017|040|H|injection site) with rubbing alcohol. Change the injection site||
5017|041|H|each time to lessen injury under the skin. To lessen bruising, do||
5017|042|H|not rub the injection site after a shot. Learn how to store and||
5017|043|H|discard medical supplies safely.||
5017|044|H|   Use this medication exactly as directed by your doctor to get||
5017|045|H|the most benefit from it. Do not increase your dose or use this||
5017|046|H|drug more often or for longer than prescribed.||
5017|047|B|||
5017|048|S|SIDE EFFECTS:  Headache, mild stomach/abdominal pain, bloating,||
5017|049|S|redness/pain at the injection site, or breast tenderness/pain may||
5017|050|S|occur. If any of these effects last or get worse, tell your||
5017|051|S|doctor or pharmacist promptly.||
5017|052|S|   Remember that this medication has been prescribed because your||
5017|053|S|doctor has judged that the benefit to you is greater than the||
5017|054|S|risk of side effects. Many people using this medication do not||
5017|055|S|have serious side effects.||
5017|056|S|   Tell your doctor right away if you have any serious side||
5017|057|S|effects, including: bleeding from the vagina/uterus, swelling of||
5017|058|S|ankles/hands/feet.||
5017|059|S|   Get medical help right away if you have any very serious side||
5017|060|S|effects, including: shortness of breath/rapid breathing,||
5017|061|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
5017|062|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
5017|063|S|sudden severe headache, trouble speaking, weakness on one side of||
5017|064|S|the body, sudden vision changes.||
5017|065|S|   This medication may cause a condition known as ovarian||
5017|066|S|hyperstimulation syndrome (OHSS). This condition may occur during||
5017|067|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
5017|068|S|build up in the stomach, chest, and heart area. Get medical help||
5017|069|S|right away if you develop the following side effects: severe pain||
5017|070|S|or swelling in the lower abdominal (pelvic) area, severe||
5017|071|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
5017|072|S|urination.||
5017|073|S|   A very serious allergic reaction to this drug is rare.||
5017|074|S|However, get medical help right away if you notice any symptoms||
5017|075|S|of a serious allergic reaction, including: rash, itching/swelling||
5017|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5017|077|S|breathing.||
5017|078|S|   This is not a complete list of possible side effects. If you||
5017|079|S|notice other effects not listed above, contact your doctor or||
5017|080|S|pharmacist.||
5017|081|S|   In the US -||
5017|082|S|   Call your doctor for medical advice about side effects. You||
5017|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5017|084|S|www.fda.gov/medwatch.||
5017|085|S|   In Canada - Call your doctor for medical advice about side||
5017|086|S|effects. You may report side effects to Health Canada at||
5017|087|S|1-866-234-2345.||
5017|088|B|||
5017|089|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
5017|090|P|pharmacist if you are allergic to it; or to other products||
5017|091|P|containing follicle-stimulating hormone (FSH); or if you have any||
5017|092|P|other allergies. This product may contain inactive ingredients,||
5017|093|P|which can cause allergic reactions or other problems. Talk to||
5017|094|P|your pharmacist for more details.||
5017|095|P|   Before using this medication, tell your doctor or pharmacist||
5017|096|P|your medical history, especially of: other fertility problems||
5017|097|P|(such as primary ovarian failure), abnormal bleeding from the||
5017|098|P|vagina/uterus, thyroid problems, adrenal gland problems, cancer||
5017|099|P|of the reproductive organs (such as breast, uterus, ovary), tumor||
5017|100|P|in the brain (such as pituitary tumor), ovarian cysts or enlarged||
5017|101|P|ovaries, blood clots, stroke, certain heart diseases (such as||
5017|102|P|angina, heart attack), lung problems (such as asthma).||
5017|103|P|   Before having surgery, tell your doctor or dentist about all||
5017|104|P|the products you use (including prescription drugs,||
5017|105|P|nonprescription drugs, and herbal products).||
5017|106|P|   Multiple births may occur as a result of this treatment.||
5017|107|P|Consult your doctor for more details.||
5017|108|P|   Stop using this medication when you become pregnant. This||
5017|109|P|medication must not be used during pregnancy. If you think you||
5017|110|P|may be pregnant, tell your doctor right away.||
5017|111|P|   It is unknown if this drug passes into breast milk. Consult||
5017|112|P|your doctor before breastfeeding.||
5017|113|B|||
5017|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5017|115|I|medications work or increase your risk for serious side effects.||
5017|116|I|This document does not contain all possible drug interactions.||
5017|117|I|Keep a list of all the products you use (including||
5017|118|I|prescription/nonprescription drugs and herbal products) and share||
5017|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
5017|120|I|the dosage of any medicines without your doctor's approval.||
5017|121|I|   A product that may interact with this drug is: gonadorelin.||
5017|122|B|||
5017|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5017|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5017|125|O|poison control center right away. US residents can call||
5017|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5017|127|B|||
5017|128|N|NOTES:  Do not share this medication with others.||
5017|129|N|   Lab and/or medical tests (such as vaginal ultrasound, hormone||
5017|130|N|levels, liver tests) may be done while you are using this||
5017|131|N|medication. Keep all medical and lab appointments. Consult your||
5017|132|N|doctor for more details.||
5017|133|B|||
5017|134|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
5017|135|D|right away for a new dosing schedule. Do not double the dose to||
5017|136|D|catch up.||
5017|137|B|||
5017|138|R|STORAGE:  Store in the refrigerator or at room temperature away||
5017|139|R|from light. Do not freeze. Keep all medications away from||
5017|140|R|children and pets.||
5017|141|R|   Do not flush medications down the toilet or pour them into a||
5017|142|R|drain unless instructed to do so. Properly discard this product||
5017|143|R|when it is expired or no longer needed. Consult your pharmacist||
5017|144|R|or local waste disposal company.||
5017|145|B|||
5017|146|A|Information last revised September 2024.||
5017|147|A|Copyright(c) 2025 First Databank, Inc.||
5017|148|B|||
5018|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5018|002|Z|does NOT have all possible information about this product. This||
5018|003|Z|information does not assure that this product is safe, effective,||
5018|004|Z|or appropriate for you. This information is not individual||
5018|005|Z|medical advice and does not substitute for the advice of your||
5018|006|Z|health care professional. Always ask your health care||
5018|007|Z|professional for complete information about this product and your||
5018|008|Z|specific health needs.||
5018|009|B|||
5018|010|T|FENTANYL - TRANSDERMAL||
5018|011|F|(FEN-ta-nil)||
5018|012|B|||
5018|013|C|COMMON BRAND NAME(S): Duragesic||
5018|014|B|||
5018|015|W|WARNING:  Fentanyl has a risk for abuse and addiction, which can||
5018|016|W|lead to overdose and death. Fentanyl may also cause severe,||
5018|017|W|possibly fatal, breathing problems. Do not use transdermal||
5018|018|W|patches unless you have been regularly using moderate to large||
5018|019|W|amounts of opioid pain medication. Otherwise, it may cause||
5018|020|W|overdose (even death). To lower your risk, your doctor should||
5018|021|W|have you use the smallest dose of fentanyl that works, and use it||
5018|022|W|for the shortest possible time. See also How to Use section for||
5018|023|W|more information about addiction.||
5018|024|W|   Ask your doctor or pharmacist if you should have medication||
5018|025|W|available to treat opioid overdose (such as naloxone, nalmefene).||
5018|026|W|Teach your family or household members about the signs of an||
5018|027|W|opioid overdose and how to treat it.||
5018|028|W|   The risk for severe breathing problems is higher when you||
5018|029|W|start this medication and after a dose increase, or if you use||
5018|030|W|the wrong dose/strength. Using this medication with alcohol or||
5018|031|W|other drugs that can cause drowsiness or breathing problems may||
5018|032|W|cause very serious side effects, including death. Be sure you||
5018|033|W|know how to use fentanyl and what other drugs you should avoid||
5018|034|W|using with it. See also Drug Interactions section. Get medical||
5018|035|W|help right away if any of these very serious side effects occur:||
5018|036|W|slow/shallow breathing, unusual lightheadedness, severe||
5018|037|W|drowsiness/dizziness, difficulty waking up.||
5018|038|W|   Do not use this medication to relieve mild, short-term, or||
5018|039|W|sudden pain (such as due to headache/migraine, dental/medical||
5018|040|W|procedures), or pain after surgery (including same-day surgery||
5018|041|W|when you do not need to stay in the hospital overnight). This||
5018|042|W|medication is not for occasional ("as needed") use.||
5018|043|W|   Since they are not used the same way, different forms of||
5018|044|W|fentanyl (including lozenges, buccal tablets, patches) do not||
5018|045|W|have the same effects at equal strengths and should not be||
5018|046|W|substituted for each other. Tell your doctor or pharmacist of all||
5018|047|W|medications that you use, especially of drugs that can affect how||
5018|048|W|fentanyl works. Do not start, stop, or change the dosage of any||
5018|049|W|medicines you are using without your doctor's approval.||
5018|050|W|   Carefully follow the manufacturer's instructions for using||
5018|051|W|fentanyl transdermal patches. The patches are for use on the skin||
5018|052|W|only. Raising your skin/body temperature, using cut or damaged||
5018|053|W|fentanyl patches, or using the patch improperly (such as by||
5018|054|W|chewing it) may cause fatal overdose. Avoid increasing your skin||
5018|055|W|temperature at/near the application site by using products such||
5018|056|W|as heating pads, electric blankets, hot tubs, heat lamps, or||
5018|057|W|tanning lamps. Avoid taking hot baths and sunbathing. However,||
5018|058|W|you may bathe, shower, or swim while wearing the patch as long as||
5018|059|W|you avoid hot water.||
5018|060|W|   Before using this medication, women of childbearing age should||
5018|061|W|talk with their doctor(s) about the risks and benefits. Tell your||
5018|062|W|doctor if you are pregnant or if you plan to become pregnant.||
5018|063|W|During pregnancy, this medication should be used only when||
5018|064|W|clearly needed. It may slightly increase the risk of birth||
5018|065|W|defects if used during the first two months of pregnancy. Also,||
5018|066|W|using it for a long time or in high doses near the expected||
5018|067|W|delivery date may harm the unborn baby. To lessen the risk, use||
5018|068|W|the smallest effective dose for the shortest possible time.||
5018|069|W|Babies born to mothers who use this drug for a long time may||
5018|070|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
5018|071|W|doctor right away if you notice any symptoms in your newborn baby||
5018|072|W|such as crying that doesn't stop, slow/shallow breathing,||
5018|073|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
5018|074|W|difficulty gaining weight.||
5018|075|W|   Keep this medicine in a safe place to prevent theft, misuse,||
5018|076|W|or abuse. This medication is not recommended for use by children||
5018|077|W|younger than 2 years. Some manufacturers recommend that this||
5018|078|W|product should not be used by children younger than 18 years. If||
5018|079|W|someone accidentally swallows this drug, get medical help right||
5018|080|W|away.||
5018|081|B|||
5018|082|U|USES:  This medication is used to help relieve severe ongoing||
5018|083|U|pain (such as due to cancer). Fentanyl belongs to a class of||
5018|084|U|drugs known as opioid analgesics. It works in the brain to change||
5018|085|U|how your body feels and responds to pain.||
5018|086|U|   Do not use the patch form of fentanyl to relieve pain that is||
5018|087|U|mild or that will go away in a few days. This medication is not||
5018|088|U|for occasional ("as needed") use.||
5018|089|B|||
5018|090|H|HOW TO USE:  See also Warning section.||
5018|091|H|   Read the Medication Guide and, if available, the Instructions||
5018|092|H|for Use provided by your pharmacist before you start using this||
5018|093|H|medication and each time you get a refill. Learn how to properly||
5018|094|H|use, store, and discard the patches. If you have any questions,||
5018|095|H|ask your doctor or pharmacist.||
5018|096|H|   Use this medication on a regular schedule as directed by your||
5018|097|H|doctor, not as needed for sudden (breakthrough) pain.||
5018|098|H|   Before you start using this medication, ask your doctor or||
5018|099|H|pharmacist if you should stop or change how you use your other||
5018|100|H|opioid medication(s). It may take up to 24 hours before you have||
5018|101|H|pain relief from fentanyl patches. Other pain relievers (such as||
5018|102|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
5018|103|H|or pharmacist about using fentanyl safely with other drugs.||
5018|104|H|   Apply this medication to the skin as directed by your doctor.||
5018|105|H|Do not apply on burns, cuts, irritated skin, or skin that has||
5018|106|H|been exposed to radiation (x-ray treatment). Select a dry,||
5018|107|H|non-hairy area on a flat part of your body, such as the chest,||
5018|108|H|sides, back, or upper arms. In young children or in people unable||
5018|109|H|to think clearly (such as due to dementia), apply the patch on||
5018|110|H|the upper back to lessen the chance it might be removed or placed||
5018|111|H|in the mouth. If there is hair on the skin, use scissors to clip||
5018|112|H|the hair as close as possible to the skin. Do not shave hair||
5018|113|H|since this might cause skin irritation. If needed, use water to||
5018|114|H|clean the area. Do not use soap, oils, lotions, or alcohol on the||
5018|115|H|application site. Dry the skin well before applying the patch.||
5018|116|H|   The patch is usually changed every 72 hours. To avoid||
5018|117|H|irritation, apply to a different area each time. Be sure to||
5018|118|H|remove the old patch before applying a new patch. The used patch||
5018|119|H|still contains enough fentanyl to cause serious harm, even kill a||
5018|120|H|child or pet, so fold it in half with the sticky sides together||
5018|121|H|and discard properly. Do not let children see you apply a patch,||
5018|122|H|and do not apply the patch where children can see it. Children||
5018|123|H|have found patches that have fallen off or removed patches on||
5018|124|H|sleeping adults and put them in their mouths or on their bodies||
5018|125|H|with fatal results. (See also Warning section).||
5018|126|H|   Do not use the patch if it appears to be broken, cut, or||
5018|127|H|damaged. Remove from the sealed pouch, peel off the protective||
5018|128|H|liner, and apply right away to the skin. Press firmly in place||
5018|129|H|with the palm of the hand for 30 seconds, making sure the contact||
5018|130|H|is complete (especially around the edges). If your prescribed||
5018|131|H|dose is for more than one patch, make sure the edges of the||
5018|132|H|patches do not touch or overlap. Wash your hands after applying||
5018|133|H|the patch.||
5018|134|H|   If you have problems with the patch not sticking at the||
5018|135|H|application site, you may tape the edges in place with first aid||
5018|136|H|tape. If this problem lasts, ask your doctor for advice. If the||
5018|137|H|patch falls off before 72 hours, a new patch may be applied to a||
5018|138|H|different skin site. Be sure to let your doctor know if this||
5018|139|H|happens.||
5018|140|H|   If you accidentally touch the sticky layer to your skin or||
5018|141|H|handle a cut or damaged patch, wash the area well with clear||
5018|142|H|water. If the patch comes off and accidentally sticks to the skin||
5018|143|H|of another person, immediately remove the patch, wash the area||
5018|144|H|with water, and get medical help for them right away. Do not use||
5018|145|H|soap, alcohol, or other products to wash the area.||
5018|146|H|   The dosage is based on your medical condition and response to||
5018|147|H|treatment. Do not apply more patches than directed, change them||
5018|148|H|more often, or use them for a longer time than prescribed.||
5018|149|H|   Suddenly stopping this medication may cause withdrawal,||
5018|150|H|especially if you have used it for a long time or in high doses.||
5018|151|H|To prevent withdrawal, your doctor may lower your dose slowly.||
5018|152|H|Tell your doctor or pharmacist right away if you have any||
5018|153|H|withdrawal symptoms such as restlessness, mental/mood changes||
5018|154|H|(including anxiety, trouble sleeping, thoughts of suicide),||
5018|155|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
5018|156|H|aches, or sudden changes in behavior.||
5018|157|H|   When this medication is used for a long time, it may not work||
5018|158|H|as well. Talk with your doctor if this medication stops working||
5018|159|H|well.||
5018|160|H|   Though it helps many people, this medication may sometimes||
5018|161|H|cause addiction. This risk may be higher if you have a||
5018|162|H|mental/mood disorder or a substance use disorder (such as overuse||
5018|163|H|of or addiction to drugs/alcohol). Use this medication exactly as||
5018|164|H|prescribed to lower the risk of addiction. Ask your doctor or||
5018|165|H|pharmacist for more details.||
5018|166|H|   Tell your doctor if your pain does not get better or if it||
5018|167|H|gets worse, or if you have any new pain.||
5018|168|B|||
5018|169|S|SIDE EFFECTS:  See also Warning section.||
5018|170|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
5018|171|S|drowsiness, or headache may occur. Mild irritation, itching, or||
5018|172|S|redness at the application site may also occur. Some of these||
5018|173|S|side effects may decrease after you have been using this||
5018|174|S|medication for a while. If any of these effects last or get||
5018|175|S|worse, tell your doctor or pharmacist promptly.||
5018|176|S|   To prevent constipation, eat dietary fiber, drink enough||
5018|177|S|water, and exercise. You may also need to take a laxative. Ask||
5018|178|S|your pharmacist which type of laxative is right for you.||
5018|179|S|   To reduce the risk of dizziness and lightheadedness, get up||
5018|180|S|slowly when rising from a sitting or lying position.||
5018|181|S|   Remember that this medication has been prescribed because your||
5018|182|S|doctor has judged that the benefit to you is greater than the||
5018|183|S|risk of side effects. Many people using this medication do not||
5018|184|S|have serious side effects.||
5018|185|S|   Tell your doctor right away if you have any serious side||
5018|186|S|effects, including: interrupted breathing during sleep (sleep||
5018|187|S|apnea), mental/mood changes (such as agitation, confusion,||
5018|188|S|hallucinations), severe stomach/abdominal pain, difficulty||
5018|189|S|urinating, slow/fast/pounding heartbeat, signs of your adrenal||
5018|190|S|glands not working well (such as loss of appetite, unusual||
5018|191|S|tiredness, weight loss), trouble swallowing.||
5018|192|S|   Get medical help right away if you have any very serious side||
5018|193|S|effects, including: fainting, seizure, slow/shallow breathing,||
5018|194|S|severe drowsiness/difficulty waking up.||
5018|195|S|   This medication may increase serotonin and rarely cause a very||
5018|196|S|serious condition called serotonin syndrome/toxicity. The risk||
5018|197|S|increases if you are also taking other drugs that increase||
5018|198|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
5018|199|S|take (see Drug Interactions section). Get medical help right away||
5018|200|S|if you develop some of the following symptoms: fast heartbeat,||
5018|201|S|hallucinations, loss of coordination, severe dizziness, severe||
5018|202|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
5018|203|S|unusual agitation/restlessness.||
5018|204|S|   A very serious allergic reaction to this drug is rare.||
5018|205|S|However, get medical help right away if you notice any symptoms||
5018|206|S|of a serious allergic reaction, including: rash, itching/swelling||
5018|207|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5018|208|S|breathing.||
5018|209|S|   This is not a complete list of possible side effects. If you||
5018|210|S|notice other effects not listed above, contact your doctor or||
5018|211|S|pharmacist.||
5018|212|S|   In the US -||
5018|213|S|   Call your doctor for medical advice about side effects. You||
5018|214|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5018|215|S|www.fda.gov/medwatch.||
5018|216|S|   In Canada - Call your doctor for medical advice about side||
5018|217|S|effects. You may report side effects to Health Canada at||
5018|218|S|1-866-234-2345.||
5018|219|B|||
5018|220|P|PRECAUTIONS:  Before using fentanyl, tell your doctor or||
5018|221|P|pharmacist if you are allergic to it; or to adhesives; or if you||
5018|222|P|have any other allergies. This product may contain inactive||
5018|223|P|ingredients, which can cause allergic reactions or other||
5018|224|P|problems. Talk to your pharmacist for more details.||
5018|225|P|   Before using this medication, tell your doctor or pharmacist||
5018|226|P|your medical history, especially of: brain disorders (such as||
5018|227|P|head injury, tumor, seizures), breathing problems (such as||
5018|228|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
5018|229|P|kidney disease, liver disease, mental/mood disorders (such as||
5018|230|P|confusion, depression), personal or family history of a substance||
5018|231|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
5018|232|P|stomach/intestinal problems (such as blockage, constipation,||
5018|233|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
5018|234|P|(such as due to enlarged prostate), disease of the pancreas||
5018|235|P|(pancreatitis), gallbladder disease, slow/fast/irregular||
5018|236|P|heartbeat.||
5018|237|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5018|238|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5018|239|P|machinery, or do anything that needs alertness until you can do||
5018|240|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5018|241|P|are using marijuana (cannabis).||
5018|242|P|   Tell your doctor promptly if you develop a fever, since this||
5018|243|P|rise in body temperature may cause overdose (see also Warning||
5018|244|P|section). Avoid activities that might cause your body temperature||
5018|245|P|to rise. (such as doing strenuous work/exercise in hot weather).||
5018|246|P|   Before having surgery, tell your doctor or dentist about all||
5018|247|P|the products you use (including prescription drugs,||
5018|248|P|nonprescription drugs, and herbal products).||
5018|249|P|   If you are going to have an MRI test, tell testing personnel||
5018|250|P|that you are using this patch. Some patches may contain metals||
5018|251|P|that can cause serious burns during an MRI. Ask your doctor||
5018|252|P|whether you will need to remove your patch before the test and||
5018|253|P|apply a new patch afterward, and how to do so properly.||
5018|254|P|   Older adults may be more sensitive to the side effects of this||
5018|255|P|drug, especially confusion, dizziness, drowsiness, and||
5018|256|P|slow/shallow breathing.||
5018|257|P|   During pregnancy, this medication should be used only when||
5018|258|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
5018|259|P|benefits with your doctor. (See also Warning section.)||
5018|260|P|   This drug passes into breast milk and may have undesirable||
5018|261|P|effects on a nursing infant. Tell the doctor right away if your||
5018|262|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
5018|263|P|breathing. Consult your doctor before breastfeeding.||
5018|264|B|||
5018|265|I|DRUG INTERACTIONS:  See also Warning section.||
5018|266|I|   Drug interactions may change how your medications work or||
5018|267|I|increase your risk for serious side effects. This document does||
5018|268|I|not contain all possible drug interactions. Keep a list of all||
5018|269|I|the products you use (including prescription/nonprescription||
5018|270|I|drugs and herbal products) and share it with your doctor and||
5018|271|I|pharmacist. Do not start, stop, or change the dosage of any||
5018|272|I|medicines without your doctor's approval.||
5018|273|I|   Some products that may interact with this drug include:||
5018|274|I|certain pain medications (mixed opioid agonist-antagonists such||
5018|275|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
5018|276|I|samidorphan.||
5018|277|I|   Other medications can affect the removal of fentanyl from your||
5018|278|I|body, which may affect how fentanyl works. Examples include azole||
5018|279|I|antifungals (such as itraconazole, ketoconazole), calcium channel||
5018|280|I|blockers (such as diltiazem, verapamil), HIV protease inhibitors||
5018|281|I|(such as nelfinavir), macrolide antibiotics (such as||
5018|282|I|erythromycin), mifepristone, nefazodone, rifamycins (such as||
5018|283|I|rifabutin), ritonavir, certain drugs used to treat seizures (such||
5018|284|I|as carbamazepine, phenytoin), among others.||
5018|285|I|   Taking MAO inhibitors with this medication may cause a serious||
5018|286|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
5018|287|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
5018|288|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
5018|289|I|selegiline, tranylcypromine) during treatment with this||
5018|290|I|medication. Most MAO inhibitors should also not be taken for two||
5018|291|I|weeks before treatment with this medication. Ask your doctor when||
5018|292|I|to start or stop taking this medication.||
5018|293|I|   The risk of serious side effects (such as slow/shallow||
5018|294|I|breathing, severe drowsiness/dizziness) may be increased if this||
5018|295|I|medication is used with other products that may also cause||
5018|296|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5018|297|I|if you are taking other products such as other opioid pain or||
5018|298|I|cough relievers (such as codeine, hydrocodone), alcohol,||
5018|299|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
5018|300|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
5018|301|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
5018|302|I|cetirizine, diphenhydramine).||
5018|303|I|   Check the labels on all your medicines (such as allergy or||
5018|304|I|cough-and-cold products) because they may contain ingredients||
5018|305|I|that cause drowsiness. Ask your pharmacist about using those||
5018|306|I|products safely.||
5018|307|I|   The risk of serotonin syndrome/toxicity increases if you are||
5018|308|I|also taking other drugs that increase serotonin. Some examples||
5018|309|I|are street drugs such as MDMA/ "ecstasy," St. John's wort,||
5018|310|I|certain antidepressants (such as SSRIs like||
5018|311|I|fluoxetine/paroxetine, SNRIs like duloxetine/venlafaxine), among||
5018|312|I|others. The risk of serotonin syndrome/toxicity may be more||
5018|313|I|likely when you start or increase the dose of these drugs.||
5018|314|I|   This medication may interfere with certain lab tests (such as||
5018|315|I|amylase/lipase levels), possibly causing false test results. Make||
5018|316|I|sure lab personnel and all your doctors know you use this drug.||
5018|317|B|||
5018|318|O|OVERDOSE:  This medication patch may be harmful if chewed or||
5018|319|O|swallowed. If someone has overdosed, remove the patch if||
5018|320|O|possible. For serious symptoms such as passing out or trouble||
5018|321|O|breathing, give them naloxone or nalmefene if available, then||
5018|322|O|call 911. If the person is awake and has no symptoms, call a||
5018|323|O|poison control center right away. US residents can call||
5018|324|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5018|325|O|Symptoms of overdose may include: slow/shallow breathing, slow||
5018|326|O|heartbeat, coma.||
5018|327|B|||
5018|328|N|NOTES:  Do not share this medication with others. Sharing it is||
5018|329|N|against the law.||
5018|330|N|   This medication has been prescribed for your current condition||
5018|331|N|only. Do not use it later for another condition unless told to do||
5018|332|N|so by your doctor. A different medication may be necessary in||
5018|333|N|that case.||
5018|334|B|||
5018|335|D|MISSED DOSE:  If you leave a patch on for more than 3 days (72||
5018|336|D|hours), remove the patch and apply a new patch as soon as you||
5018|337|D|remember. Do not double the dose to catch up.||
5018|338|B|||
5018|339|R|STORAGE:  Store at room temperature. Keep the medication in the||
5018|340|R|protective pouch until ready to use. Keep all medications away||
5018|341|R|from children and pets. See also Warning section.||
5018|342|R|   Do not flush medications down the toilet or pour them into a||
5018|343|R|drain unless instructed to do so. Properly discard this product||
5018|344|R|when it is expired or no longer needed (see also How to Use||
5018|345|R|section). For more details, read the Instructions for Use, or||
5018|346|R|consult your pharmacist or local waste disposal company.||
5018|347|B|||
5018|348|A|Information last revised August 2025.||
5018|349|A|Copyright(c) 2025 First Databank, Inc.||
5018|350|B|||
5019|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5019|002|Z|does NOT have all possible information about this product. This||
5019|003|Z|information does not assure that this product is safe, effective,||
5019|004|Z|or appropriate for you. This information is not individual||
5019|005|Z|medical advice and does not substitute for the advice of your||
5019|006|Z|health care professional. Always ask your health care||
5019|007|Z|professional for complete information about this product and your||
5019|008|Z|specific health needs.||
5019|009|B|||
5019|010|T|TIAGABINE - ORAL||
5019|011|F|(tye-AG-a-been)||
5019|012|B|||
5019|013|C|COMMON BRAND NAME(S): Gabitril||
5019|014|B|||
5019|015|U|USES:  Tiagabine is used with other medications to treat certain||
5019|016|U|types of seizures (focal seizures). It works by reducing the||
5019|017|U|spread of seizure activity in the brain. This medication is known||
5019|018|U|as an anticonvulsant or anti-epileptic drug.||
5019|019|U|   When tiagabine has been used for conditions other than||
5019|020|U|epilepsy, serious reactions (including seizures in people who||
5019|021|U|have never had them) have occurred. Talk to your doctor for more||
5019|022|U|details.||
5019|023|B|||
5019|024|H|HOW TO USE:  Read the Medication Guide provided by your||
5019|025|H|pharmacist before you start taking tiagabine and each time you||
5019|026|H|get a refill. If you have any questions, ask your doctor or||
5019|027|H|pharmacist.||
5019|028|H|   Take this medication by mouth with food as directed by your||
5019|029|H|doctor. To reduce your risk of side effects, your doctor may||
5019|030|H|direct you to start this medication at a low dose and gradually||
5019|031|H|increase your dose. During the first week of treatment, this||
5019|032|H|medication is usually taken once a day. On the following weeks,||
5019|033|H|your doctor may increase your dose to 2 to 4 times daily. Follow||
5019|034|H|your doctor's instructions carefully.||
5019|035|H|   Tiagabine is not usually used by itself. Do not stop your||
5019|036|H|other anti-seizure medication unless your doctor tells you to do||
5019|037|H|so.||
5019|038|H|   The dosage is based on your medical condition, response to||
5019|039|H|treatment, and other medications you may be taking. Be sure to||
5019|040|H|tell your doctor and pharmacist about all the products you use||
5019|041|H|(including prescription drugs, nonprescription drugs, and herbal||
5019|042|H|products).||
5019|043|H|   Take this medication regularly to get the most benefit from||
5019|044|H|it. To help you remember, take it at the same times each day.||
5019|045|H|   Do not stop taking this medication without consulting your||
5019|046|H|doctor. Some conditions (such as seizures) may become worse when||
5019|047|H|this drug is suddenly stopped. Your dose may need to be gradually||
5019|048|H|decreased.||
5019|049|H|   If you stop taking this medication for several days, talk with||
5019|050|H|your doctor about how to restart it. You may need to restart with||
5019|051|H|a low dose and slowly increase your dose again.||
5019|052|H|   Tell your doctor if your seizures get worse.||
5019|053|B|||
5019|054|S|SIDE EFFECTS:  Dizziness, drowsiness, stomach pain, diarrhea,||
5019|055|S|nervousness, tiredness, or shaking may occur. If any of these||
5019|056|S|effects last or get worse, tell your doctor or pharmacist||
5019|057|S|promptly.||
5019|058|S|   Remember that this medication has been prescribed because your||
5019|059|S|doctor has judged that the benefit to you is greater than the||
5019|060|S|risk of side effects. Many people using this medication do not||
5019|061|S|have serious side effects.||
5019|062|S|   Tell your doctor right away if you have any serious side||
5019|063|S|effects, including: weakness, trouble concentrating/paying||
5019|064|S|attention, trouble speaking, confusion.||
5019|065|S|   A small number of people who take anticonvulsants for any||
5019|066|S|condition (such as seizure, bipolar disorder, pain) may||
5019|067|S|experience depression, suicidal thoughts/attempts, or other||
5019|068|S|mental/mood problems. Tell your doctor right away if you or your||
5019|069|S|family/caregiver notice any unusual/sudden changes in your mood,||
5019|070|S|thoughts, or behavior including signs of depression, suicidal||
5019|071|S|thoughts/attempts, thoughts about harming yourself.||
5019|072|S|   Get medical help right away if you have a seizure that doesn't||
5019|073|S|stop (status epilepticus). This is a very rare but very serious||
5019|074|S|side effect.||
5019|075|S|   A very serious allergic reaction to this drug is rare.||
5019|076|S|However, get medical help right away if you notice any symptoms||
5019|077|S|of a serious allergic reaction, including: rash, itching/swelling||
5019|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5019|079|S|breathing.||
5019|080|S|   This is not a complete list of possible side effects. If you||
5019|081|S|notice other effects not listed above, contact your doctor or||
5019|082|S|pharmacist.||
5019|083|S|   In the US -||
5019|084|S|   Call your doctor for medical advice about side effects. You||
5019|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5019|086|S|www.fda.gov/medwatch.||
5019|087|S|   In Canada - Call your doctor for medical advice about side||
5019|088|S|effects. You may report side effects to Health Canada at||
5019|089|S|1-866-234-2345.||
5019|090|B|||
5019|091|P|PRECAUTIONS:  Before taking tiagabine, tell your doctor or||
5019|092|P|pharmacist if you are allergic to it; or if you have any other||
5019|093|P|allergies. This product may contain inactive ingredients, which||
5019|094|P|can cause allergic reactions or other problems. Talk to your||
5019|095|P|pharmacist for more details.||
5019|096|P|   Before using this medication, tell your doctor or pharmacist||
5019|097|P|your medical history, especially of: liver disease, mental/mood||
5019|098|P|disorders (such as depression, suicidal thoughts), seizure that||
5019|099|P|doesn't stop (status epilepticus).||
5019|100|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5019|101|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5019|102|P|machinery, or do anything that needs alertness until you can do||
5019|103|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5019|104|P|are using marijuana (cannabis).||
5019|105|P|   Before having surgery, tell your doctor or dentist about all||
5019|106|P|the products you use (including prescription drugs,||
5019|107|P|nonprescription drugs, and herbal products).||
5019|108|P|   Older adults may be more sensitive to the side effects of this||
5019|109|P|drug, especially dizziness or confusion. These effects can||
5019|110|P|increase the risk of falling.||
5019|111|P|   During pregnancy, this medication should be used only when||
5019|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
5019|113|P|   It is unknown if this drug passes into breast milk. Consult||
5019|114|P|your doctor before breastfeeding.||
5019|115|B|||
5019|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5019|117|I|medications work or increase your risk for serious side effects.||
5019|118|I|This document does not contain all possible drug interactions.||
5019|119|I|Keep a list of all the products you use (including||
5019|120|I|prescription/nonprescription drugs and herbal products) and share||
5019|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
5019|122|I|the dosage of any medicines without your doctor's approval.||
5019|123|I|   A product that may interact with this drug is: orlistat.||
5019|124|I|   Tell your doctor or pharmacist if you are taking other||
5019|125|I|products that cause drowsiness including alcohol, marijuana||
5019|126|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
5019|127|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
5019|128|I|zolpidem), muscle relaxants (such as carisoprodol,||
5019|129|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
5019|130|I|hydrocodone).||
5019|131|I|   Check the labels on all your medicines (such as allergy or||
5019|132|I|cough-and-cold products) because they may contain ingredients||
5019|133|I|that cause drowsiness. Ask your pharmacist about using those||
5019|134|I|products safely.||
5019|135|B|||
5019|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5019|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5019|138|O|poison control center right away. US residents can call||
5019|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5019|140|O|Symptoms of overdose may include: severe drowsiness, uncontrolled||
5019|141|O|seizure, slow/shallow breathing, loss of consciousness.||
5019|142|B|||
5019|143|N|NOTES:  Do not share this medication with others.||
5019|144|N|   Lab and/or medical tests (such as tiagabine blood levels)||
5019|145|N|should be done while you are taking this medication. Keep all||
5019|146|N|medical and lab appointments.||
5019|147|B|||
5019|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5019|149|D|remember. If it is near the time of the next dose, skip the||
5019|150|D|missed dose. Take your next dose at the regular time. Do not||
5019|151|D|double the dose to catch up. If you miss taking this medication||
5019|152|D|for several days, contact your doctor for instructions.||
5019|153|B|||
5019|154|R|STORAGE:  Store at room temperature away from light and moisture.||
5019|155|R|Do not store in the bathroom. Keep all medications away from||
5019|156|R|children and pets.||
5019|157|R|   Do not flush medications down the toilet or pour them into a||
5019|158|R|drain unless instructed to do so. Properly discard this product||
5019|159|R|when it is expired or no longer needed. Consult your pharmacist||
5019|160|R|or local waste disposal company.||
5019|161|B|||
5019|162|M|MEDICAL ALERT:  Your condition can cause complications in a||
5019|163|M|medical emergency. For information about enrolling in MedicAlert,||
5019|164|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5019|165|B|||
5019|166|A|Information last revised May 2024.||
5019|167|A|Copyright(c) 2025 First Databank, Inc.||
5019|168|B|||
5021|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5021|002|Z|does NOT have all possible information about this product. This||
5021|003|Z|information does not assure that this product is safe, effective,||
5021|004|Z|or appropriate for you. This information is not individual||
5021|005|Z|medical advice and does not substitute for the advice of your||
5021|006|Z|health care professional. Always ask your health care||
5021|007|Z|professional for complete information about this product and your||
5021|008|Z|specific health needs.||
5021|009|B|||
5021|010|T|DEXAMETHASONE - ORAL||
5021|011|F|(dex-uh-METH-uh-sown)||
5021|012|B|||
5021|013|C|COMMON BRAND NAME(S): Decadron||
5021|014|B|||
5021|015|U|USES:  Dexamethasone is used to treat conditions such as||
5021|016|U|arthritis, blood/hormone disorders, allergic reactions, skin||
5021|017|U|diseases, eye problems, breathing problems, bowel disorders,||
5021|018|U|cancer, and immune system disorders. It is also used as a test||
5021|019|U|for an adrenal gland disorder (Cushing's syndrome).||
5021|020|U|   Dexamethasone belongs to a class of drugs known as||
5021|021|U|corticosteroids. It decreases your immune system's response to||
5021|022|U|various diseases to reduce symptoms such as swelling and||
5021|023|U|allergic-type reactions.||
5021|024|B|||
5021|025|V|OTHER USES:  This section contains uses of this drug that are not||
5021|026|V|listed in the approved professional labeling for the drug but||
5021|027|V|that may be prescribed by your health care professional. Use this||
5021|028|V|drug for a condition that is listed in this section only if it||
5021|029|V|has been so prescribed by your health care professional.||
5021|030|V|   This drug may also be used to reduce the risk of nausea and||
5021|031|V|vomiting caused by cancer chemotherapy.||
5021|032|V|   Dexamethasone may also be used for COVID-19, but is only||
5021|033|V|effective in hospitalized patients who need supplemental oxygen||
5021|034|V|or a mechanical ventilator to breathe.||
5021|035|B|||
5021|036|H|HOW TO USE:  Take this medication by mouth as directed by your||
5021|037|H|doctor. Take with food or milk to prevent stomach upset. Take the||
5021|038|H|tablet form of this medication with a full glass of water (8||
5021|039|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
5021|040|H|If you are using the liquid form of this medication, carefully||
5021|041|H|measure the dose using a special measuring device/spoon. Do not||
5021|042|H|use a household spoon because you may not get the correct dose.||
5021|043|H|   If you take this medication once daily, take it in the morning||
5021|044|H|before 9 AM. If you are taking this medication every other day or||
5021|045|H|on another schedule besides a daily one, it may help to mark your||
5021|046|H|calendar with a reminder.||
5021|047|H|   The dosage and length of treatment are based on your medical||
5021|048|H|condition and response to treatment. Take this medication exactly||
5021|049|H|as prescribed. Follow the dosing schedule carefully. Your doctor||
5021|050|H|may attempt to reduce your dose slowly from time to time to||
5021|051|H|minimize side effects.||
5021|052|H|   Do not stop taking this medication without consulting your||
5021|053|H|doctor. Some conditions may become worse when this drug is||
5021|054|H|suddenly stopped. Also, you may experience symptoms such as||
5021|055|H|nausea, dizziness, weakness, or muscle/joint pain. To prevent||
5021|056|H|these symptoms while you are stopping treatment with this drug,||
5021|057|H|your doctor may reduce your dose gradually. Consult your doctor||
5021|058|H|or pharmacist for more details. Report any new or worsening||
5021|059|H|symptoms right away.||
5021|060|H|   Tell your doctor if your condition does not get better or if||
5021|061|H|it gets worse.||
5021|062|B|||
5021|063|S|SIDE EFFECTS:  Stomach upset, heartburn, headache, trouble||
5021|064|S|sleeping, or increased appetite may occur. If any of these||
5021|065|S|effects last or get worse, tell your doctor or pharmacist||
5021|066|S|promptly.||
5021|067|S|   Remember that this medication has been prescribed because your||
5021|068|S|doctor has judged that the benefit to you is greater than the||
5021|069|S|risk of side effects. Many people using this medication do not||
5021|070|S|have serious side effects.||
5021|071|S|   Tell your doctor right away if you have any serious side||
5021|072|S|effects, including: signs of infection (such as sore throat that||
5021|073|S|doesn't go away, fever, chills), bone/joint pain,||
5021|074|S|fast/slow/irregular heartbeat, eye pain/pressure, vision||
5021|075|S|problems, unusual weight gain, puffy face, swelling of the||
5021|076|S|ankles/feet, symptoms of stomach/intestinal bleeding (such as||
5021|077|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
5021|078|S|coffee grounds), mental/mood changes (such as depression, mood||
5021|079|S|swings, agitation), menstrual period changes, muscle pain/cramps,||
5021|080|S|weakness, easy bruising/bleeding, slow wound healing, thinning||
5021|081|S|skin, seizures, red/purple spots on the skin.||
5021|082|S|   This medication may rarely make your blood sugar rise, which||
5021|083|S|can cause or worsen diabetes. Tell your doctor right away if you||
5021|084|S|have symptoms of high blood sugar such as increased||
5021|085|S|thirst/urination. If you already have diabetes, check your blood||
5021|086|S|sugar regularly as directed and share the results with your||
5021|087|S|doctor. Your doctor may need to adjust your diabetes medication,||
5021|088|S|exercise program, or diet.||
5021|089|S|   A very serious allergic reaction to this drug is rare.||
5021|090|S|However, get medical help right away if you notice any symptoms||
5021|091|S|of a serious allergic reaction, including: rash, itching/swelling||
5021|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5021|093|S|breathing.||
5021|094|S|   This is not a complete list of possible side effects. If you||
5021|095|S|notice other effects not listed above, contact your doctor or||
5021|096|S|pharmacist.||
5021|097|S|   In the US -||
5021|098|S|   Call your doctor for medical advice about side effects. You||
5021|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5021|100|S|www.fda.gov/medwatch.||
5021|101|S|   In Canada - Call your doctor for medical advice about side||
5021|102|S|effects. You may report side effects to Health Canada at||
5021|103|S|1-866-234-2345.||
5021|104|B|||
5021|105|P|PRECAUTIONS:  Before taking dexamethasone, tell your doctor or||
5021|106|P|pharmacist if you are allergic to it; or if you have any other||
5021|107|P|allergies. This product may contain inactive ingredients, which||
5021|108|P|can cause allergic reactions or other problems. Talk to your||
5021|109|P|pharmacist for more details.||
5021|110|P|   Before using this medication, tell your doctor or pharmacist||
5021|111|P|your medical history, especially of: infections (such as||
5021|112|P|tuberculosis, herpes, fungal infections), kidney disease, liver||
5021|113|P|disease (such as hepatitis B), mental/mood disorders (such as||
5021|114|P|psychosis, anxiety, depression), mineral imbalance (such as low||
5021|115|P|level of potassium/calcium in the blood), thyroid disease,||
5021|116|P|stomach/intestinal problems (such as ulcer, ulcerative colitis,||
5021|117|P|diverticulitis, unexplained diarrhea), high blood pressure, heart||
5021|118|P|problems (such as heart failure, recent heart attack), diabetes,||
5021|119|P|eye diseases (such as cataracts, glaucoma), bone loss||
5021|120|P|(osteoporosis), blood clots, a certain adrenal gland tumor||
5021|121|P|(pheochromocytoma).||
5021|122|P|   Using corticosteroid medications for a long time can make it||
5021|123|P|more difficult for your body to respond to physical stress.||
5021|124|P|Before having surgery or emergency treatment, or if you get a||
5021|125|P|serious illness/injury, tell your doctor or dentist that you are||
5021|126|P|using this medication or have used this medication within the||
5021|127|P|past 12 months. Tell your doctor right away if you develop||
5021|128|P|unusual/extreme tiredness or weight loss. If you will be using||
5021|129|P|this medication for a long time, carry a warning card or medical||
5021|130|P|ID bracelet that identifies your use of this medication.||
5021|131|P|   This medication may mask signs of infection. It can make you||
5021|132|P|more likely to get infections or may make current infections||
5021|133|P|worse. Stay away from anyone who has an infection that may easily||
5021|134|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
5021|135|P|doctor if you have been exposed to an infection or for more||
5021|136|P|details.||
5021|137|P|   This medication may cause stomach bleeding. Daily use of||
5021|138|P|alcohol while using this medication may increase your risk for||
5021|139|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
5021|140|P|or pharmacist for more information.||
5021|141|P|   Tell your health care professional that you are using||
5021|142|P|dexamethasone before having any immunizations/vaccinations. Avoid||
5021|143|P|contact with people who have recently received live vaccines||
5021|144|P|(such as flu vaccine inhaled through the nose).||
5021|145|P|   The liquid form of this medication may contain sugar and/or||
5021|146|P|alcohol. Caution is advised if you have diabetes, liver disease,||
5021|147|P|or any other condition that requires you to limit/avoid these||
5021|148|P|substances in your diet. Ask your doctor or pharmacist about||
5021|149|P|using this product safely.||
5021|150|P|   Older adults may be more sensitive to the side effects of this||
5021|151|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
5021|152|P|mental/mood changes (such as confusion).||
5021|153|P|   This medication may slow down a child's growth if used for a||
5021|154|P|long time. Consult the doctor or pharmacist for more details. See||
5021|155|P|the doctor regularly so your child's height and growth can be||
5021|156|P|checked.||
5021|157|P|   During pregnancy, this medication should be used only when||
5021|158|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
5021|159|P|risks and benefits with your doctor. Infants born to mothers who||
5021|160|P|have been using this medication for an extended time may have||
5021|161|P|hormone problems. Tell your doctor right away if you notice||
5021|162|P|symptoms such as nausea/vomiting that doesn't stop, severe||
5021|163|P|diarrhea, or weakness in your newborn.||
5021|164|P|   It is unknown if this medication passes into breast milk.||
5021|165|P|Consult your doctor before breastfeeding.||
5021|166|B|||
5021|167|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5021|168|I|medications work or increase your risk for serious side effects.||
5021|169|I|This document does not contain all possible drug interactions.||
5021|170|I|Keep a list of all the products you use (including||
5021|171|I|prescription/nonprescription drugs and herbal products) and share||
5021|172|I|it with your doctor and pharmacist. Do not start, stop, or change||
5021|173|I|the dosage of any medicines without your doctor's approval.||
5021|174|I|   Some products that may interact with this drug include:||
5021|175|I|aldesleukin, desmopressin, drugs that can cause bleeding/bruising||
5021|176|I|(including antiplatelet drugs such as clopidogrel, "blood||
5021|177|I|thinners" such as dabigatran/warfarin, NSAIDs such as||
5021|178|I|aspirin/celecoxib/ibuprofen), mifepristone.||
5021|179|I|   This medication can speed up the removal of other medications||
5021|180|I|from your body, which may affect how they work. Examples of||
5021|181|I|affected drugs include certain cancer drugs (such as dasatinib,||
5021|182|I|lapatinib, sunitinib), praziquantel, rilpivirine, among others.||
5021|183|I|   If your doctor has told you to take low-dose aspirin to||
5021|184|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
5021|185|I|you should keep taking the aspirin unless your doctor tells you||
5021|186|I|not to. Ask your doctor or pharmacist for more details.||
5021|187|I|   This medication may interfere with certain lab tests||
5021|188|I|(including skin tests), possibly causing false test results. Make||
5021|189|I|sure lab personnel and all your doctors know you use this drug.||
5021|190|B|||
5021|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5021|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5021|193|O|poison control center right away. US residents can call||
5021|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5021|195|B|||
5021|196|N|NOTES:  Do not share this medication with others.||
5021|197|N|   If this medication is used for a long time, lab and/or medical||
5021|198|N|tests (such as blood mineral levels, blood glucose, complete||
5021|199|N|blood count, bone density tests, blood pressure, eye exams)||
5021|200|N|should be done while you are taking this medication. Keep all||
5021|201|N|medical and lab appointments. Consult your doctor for more||
5021|202|N|details.||
5021|203|N|   This medication may cause bone loss (osteoporosis) when used||
5021|204|N|for a long time. Lifestyle changes that may help reduce the risk||
5021|205|N|of bone problems include doing weight-bearing exercise, stopping||
5021|206|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
5021|207|N|D. Talk to your doctor for more details.||
5021|208|B|||
5021|209|D|MISSED DOSE:  If you are taking this medication daily and on a||
5021|210|D|regular schedule, and you miss a dose, take it as soon as you||
5021|211|D|remember. If it is near the time of the next dose, skip the||
5021|212|D|missed dose. Take your next dose at the regular time. Do not||
5021|213|D|double the dose to catch up.||
5021|214|D|   If you are taking this medication every other day or are||
5021|215|D|slowly reducing your dose, and you miss a dose, ask your doctor||
5021|216|D|or pharmacist right away for a new dosing schedule.||
5021|217|B|||
5021|218|R|STORAGE:  Store at room temperature away from light and moisture.||
5021|219|R|Do not store in the bathroom. Keep all medications away from||
5021|220|R|children and pets.||
5021|221|R|   Do not flush medications down the toilet or pour them into a||
5021|222|R|drain unless instructed to do so. Properly discard this product||
5021|223|R|when it is expired or no longer needed. Consult your pharmacist||
5021|224|R|or local waste disposal company.||
5021|225|B|||
5021|226|M|MEDICAL ALERT:  Your condition can cause complications in a||
5021|227|M|medical emergency. For information about enrolling in MedicAlert,||
5021|228|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5021|229|B|||
5021|230|A|Information last revised September 2025.||
5021|231|A|Copyright(c) 2025 First Databank, Inc.||
5021|232|B|||
5025|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5025|002|Z|does NOT have all possible information about this product. This||
5025|003|Z|information does not assure that this product is safe, effective,||
5025|004|Z|or appropriate for you. This information is not individual||
5025|005|Z|medical advice and does not substitute for the advice of your||
5025|006|Z|health care professional. Always ask your health care||
5025|007|Z|professional for complete information about this product and your||
5025|008|Z|specific health needs.||
5025|009|B|||
5025|010|T|DIFENOXIN/ATROPINE - ORAL||
5025|011|F|(DYE-fen-OX-in/AT-roe-peen)||
5025|012|B|||
5025|013|C|COMMON BRAND NAME(S): Motofen||
5025|014|B|||
5025|015|U|USES:  This medication is used to treat diarrhea. It helps to||
5025|016|U|decrease the number and frequency of bowel movements. It works by||
5025|017|U|slowing the movement of the intestines. Difenoxin is similar to||
5025|018|U|opioid pain relievers, but it acts mainly to slow the gut.||
5025|019|U|Atropine belongs to a class of drugs known as anticholinergics,||
5025|020|U|which help to dry up body fluids and also slow gut movement.||
5025|021|U|   This medication should not be used to treat diarrhea caused by||
5025|022|U|certain types of infection (such as C. difficile-associated||
5025|023|U|diarrhea following antibiotic therapy). Talk to your doctor for||
5025|024|U|more details.||
5025|025|U|   This drug is not recommended for use in children younger than||
5025|026|U|2 years due to an increased risk of very serious side effects.||
5025|027|B|||
5025|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
5025|029|H|doctor, usually after each loose stool, or every 3 or 4 hours as||
5025|030|H|needed. The dosage is based on your medical condition and||
5025|031|H|response to treatment. For adults, do not take more than 8||
5025|032|H|milligrams of difenoxin in any 24-hour period. If you need to||
5025|033|H|continue treatment once your diarrhea is controlled, your doctor||
5025|034|H|may direct you to lower your dosage. Do not increase your dose,||
5025|035|H|take it more often, or use it for longer than prescribed.||
5025|036|H|   It is important that you drink the proper amount of fluids and||
5025|037|H|minerals (electrolytes) to prevent dehydration. Tell your doctor||
5025|038|H|right away if you develop signs of dehydration (such as extreme||
5025|039|H|thirst, decreased urination, muscle cramps, weakness, fainting).||
5025|040|H|You may also need to change to a bland diet during this time to||
5025|041|H|reduce irritation to your stomach/intestines. Consult your doctor||
5025|042|H|or pharmacist for more information.||
5025|043|H|   If you suddenly stop using this medication, you may have||
5025|044|H|withdrawal symptoms (such as stomach cramps, nausea, vomiting).||
5025|045|H|To help prevent withdrawal, your doctor may lower your dose||
5025|046|H|slowly. Withdrawal is more likely if you have used this||
5025|047|H|medication for a long time or in high doses. Tell your doctor or||
5025|048|H|pharmacist right away if you have withdrawal.||
5025|049|H|   Tell your doctor if your condition does not get better after 2||
5025|050|H|days.||
5025|051|B|||
5025|052|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, tiredness,||
5025|053|S|blurred vision, dry mouth, and loss of appetite may occur. If any||
5025|054|S|of these effects last or get worse, tell your doctor or||
5025|055|S|pharmacist promptly.||
5025|056|S|   Remember that this medication has been prescribed because your||
5025|057|S|doctor has judged that the benefit to you is greater than the||
5025|058|S|risk of side effects. Many people using this medication do not||
5025|059|S|have serious side effects.||
5025|060|S|   Tell your doctor right away if you have any serious side||
5025|061|S|effects, including: stomach/abdominal pain or swelling, severe||
5025|062|S|nausea, vomiting, mental/mood changes (such as confusion,||
5025|063|S|depression), restlessness, numbness/tingling of arms/legs.||
5025|064|S|   Get medical help right away if you have any very serious side||
5025|065|S|effects, including: eye pain/swelling/redness, vision changes||
5025|066|S|(such as seeing rainbows around lights at night, blurred vision).||
5025|067|S|   A very serious allergic reaction to this drug is rare.||
5025|068|S|However, get medical help right away if you notice any symptoms||
5025|069|S|of a serious allergic reaction, including: rash, itching/swelling||
5025|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5025|071|S|breathing.||
5025|072|S|   This is not a complete list of possible side effects. If you||
5025|073|S|notice other effects not listed above, contact your doctor or||
5025|074|S|pharmacist.||
5025|075|S|   In the US -||
5025|076|S|   Call your doctor for medical advice about side effects. You||
5025|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5025|078|S|www.fda.gov/medwatch.||
5025|079|S|   In Canada - Call your doctor for medical advice about side||
5025|080|S|effects. You may report side effects to Health Canada at||
5025|081|S|1-866-234-2345.||
5025|082|B|||
5025|083|P|PRECAUTIONS:  Before taking difenoxin with atropine, tell your||
5025|084|P|doctor or pharmacist if you are allergic to either drug; or to||
5025|085|P|hyoscyamine; or if you have any other allergies. This product may||
5025|086|P|contain inactive ingredients, which can cause allergic reactions||
5025|087|P|or other problems. Talk to your pharmacist for more details.||
5025|088|P|   Before using this medication, tell your doctor or pharmacist||
5025|089|P|your medical history, especially of: liver disease (such as||
5025|090|P|obstructive jaundice, cirrhosis), current dehydration or mineral||
5025|091|P|imbalance, a certain type of bowel disease (ulcerative colitis),||
5025|092|P|personal or family history of glaucoma (angle-closure type).||
5025|093|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5025|094|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5025|095|P|machinery, or do anything that needs alertness until you can do||
5025|096|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5025|097|P|are using marijuana (cannabis).||
5025|098|P|   Before having surgery, tell your doctor or dentist about all||
5025|099|P|the products you use (including prescription drugs,||
5025|100|P|nonprescription drugs, and herbal products).||
5025|101|P|   Children, especially those with Down's syndrome, may be more||
5025|102|P|sensitive to the side effects of this product. Very serious||
5025|103|P|(possibly fatal) effects may occur if too much of this medication||
5025|104|P|is taken by children.||
5025|105|P|   During pregnancy, this medication should be used only when||
5025|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
5025|107|P|   This medication passes into breast milk. Consult your doctor||
5025|108|P|before breastfeeding.||
5025|109|B|||
5025|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5025|111|I|medications work or increase your risk for serious side effects.||
5025|112|I|This document does not contain all possible drug interactions.||
5025|113|I|Keep a list of all the products you use (including||
5025|114|I|prescription/nonprescription drugs and herbal products) and share||
5025|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
5025|116|I|the dosage of any medicines without your doctor's approval.||
5025|117|I|   Some products that may interact with this drug are:||
5025|118|I|ambenonium, MAO inhibitors (isocarboxazid, linezolid, metaxalone,||
5025|119|I|methylene blue, moclobemide, phenelzine, procarbazine,||
5025|120|I|rasagiline, safinamide, selegiline, tranylcypromine), naltrexone,||
5025|121|I|potassium tablets/capsules, pramlintide.||
5025|122|I|   Tell your doctor or pharmacist if you are taking other||
5025|123|I|products that cause drowsiness such as opioid pain or cough||
5025|124|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5025|125|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5025|126|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5025|127|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5025|128|I|diphenhydramine).||
5025|129|I|   Check the labels on all your medicines (such as allergy or||
5025|130|I|cough-and-cold products) because they may contain ingredients||
5025|131|I|that cause drowsiness. Ask your pharmacist about using those||
5025|132|I|products safely.||
5025|133|B|||
5025|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5025|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5025|136|O|poison control center right away. US residents can call||
5025|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5025|138|O|Symptoms of overdose may include: severe drowsiness, muscle||
5025|139|O|weakness, fast heartbeat, high fever, unusually||
5025|140|O|fast/slow/irregular breathing, seizures, loss of consciousness.||
5025|141|B|||
5025|142|N|NOTES:  Do not share this medication with others. Sharing it is||
5025|143|N|against the law.||
5025|144|B|||
5025|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5025|146|D|remember. If it is near the time of the next dose, skip the||
5025|147|D|missed dose. Take your next dose at the regular time. Do not||
5025|148|D|double the dose to catch up.||
5025|149|B|||
5025|150|R|STORAGE:  Store at room temperature away from light and moisture.||
5025|151|R|Do not store in the bathroom. Keep all medications away from||
5025|152|R|children and pets.||
5025|153|R|   Do not flush medications down the toilet or pour them into a||
5025|154|R|drain unless instructed to do so. Properly discard this product||
5025|155|R|when it is expired or no longer needed. Consult your pharmacist||
5025|156|R|or local waste disposal company.||
5025|157|B|||
5025|158|A|Information last revised November 2024.||
5025|159|A|Copyright(c) 2025 First Databank, Inc.||
5025|160|B|||
5026|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5026|002|Z|does NOT have all possible information about this product. This||
5026|003|Z|information does not assure that this product is safe, effective,||
5026|004|Z|or appropriate for you. This information is not individual||
5026|005|Z|medical advice and does not substitute for the advice of your||
5026|006|Z|health care professional. Always ask your health care||
5026|007|Z|professional for complete information about this product and your||
5026|008|Z|specific health needs.||
5026|009|B|||
5026|010|T|ERGOTAMINE/CAFFEINE - RECTAL||
5026|011|F|(er-GOT-uh-meen/KAF-een)||
5026|012|B|||
5026|013|C|COMMON BRAND NAME(S): Cafergot, Migergot||
5026|014|B|||
5026|015|W|WARNING:  This medication has rarely caused a very serious lack||
5026|016|W|of blood flow to the hands and feet (peripheral ischemia) or to||
5026|017|W|the brain, which could cause a stroke. The risk is increased when||
5026|018|W|this medication is taken with other drugs that can affect the||
5026|019|W|removal of ergotamine from your body. Examples include azole||
5026|020|W|antifungals (such as ketoconazole, itraconazole), cobicistat,||
5026|021|W|mifepristone, certain antidepressants (such as nefazodone),||
5026|022|W|macrolide antibiotics (such as clarithromycin, erythromycin,||
5026|023|W|troleandomycin), HIV protease inhibitors (such as ritonavir,||
5026|024|W|nelfinavir, indinavir), SSRIs (such as fluoxetine, paroxetine,||
5026|025|W|fluvoxamine), among others.||
5026|026|B|||
5026|027|U|USES:  This combination medication is used to treat or prevent a||
5026|028|U|certain type of headache (vascular headaches such as migraine||
5026|029|U|headaches and cluster headaches). Ergotamine helps narrow widened||
5026|030|U|blood vessels in the head, which reduces the throbbing effects of||
5026|031|U|vascular headaches. Caffeine increases the effects of ergotamine||
5026|032|U|by also narrowing the widened blood vessels in the head.||
5026|033|U|   The suppository form is used when medications cannot be taken||
5026|034|U|by mouth (for example, due to nausea and vomiting).||
5026|035|B|||
5026|036|H|HOW TO USE:  Unwrap and insert one suppository rectally as||
5026|037|H|directed by your doctor. Remain lying down for a few minutes, and||
5026|038|H|avoid having a bowel movement for an hour or longer so the drug||
5026|039|H|will be absorbed. The suppository is for rectal use only.||
5026|040|H|   If the suppository is exposed to heat and softens, chill in||
5026|041|H|ice-cold water before unwrapping and using the suppository.||
5026|042|H|   The dosage is based on your medical condition and response to||
5026|043|H|treatment. This medication works best if it is used as the first||
5026|044|H|signs of the headache occur. If you wait until the headache has||
5026|045|H|worsened, the medication may not work as well.||
5026|046|H|   This medication usually should be used only as needed. It is||
5026|047|H|not meant for long-term daily use. The maximum dose is 2||
5026|048|H|suppositories for a single headache attack and 5 suppositories in||
5026|049|H|any 7-day period.||
5026|050|H|   If you suddenly stop using this medication, you may have||
5026|051|H|withdrawal symptoms (such as rebound headaches). This headache||
5026|052|H|may be different from your original headache and may last a few||
5026|053|H|days. To help prevent withdrawal, your doctor may lower your dose||
5026|054|H|slowly. Withdrawal is more likely if you have used this||
5026|055|H|medication for a long time (more than a few weeks) or in high||
5026|056|H|doses. Tell your doctor or pharmacist right away if you have||
5026|057|H|withdrawal.||
5026|058|H|   If you are using drugs for migraine attacks on 10 or more days||
5026|059|H|each month, the drugs may actually make your headaches worse||
5026|060|H|(medication overuse headache). Do not use medications more often||
5026|061|H|or for longer than directed. Tell your doctor if you need to use||
5026|062|H|this medication more often, or if the medication is not working||
5026|063|H|as well, or if your headaches get worse.||
5026|064|B|||
5026|065|S|SIDE EFFECTS:  Nausea, vomiting, restlessness, trouble sleeping,||
5026|066|S|and dizziness may occur. If any of these effects last or get||
5026|067|S|worse, tell your doctor or pharmacist promptly.||
5026|068|S|   Remember that this medication has been prescribed because your||
5026|069|S|doctor has judged that the benefit to you is greater than the||
5026|070|S|risk of side effects. Many people using this medication do not||
5026|071|S|have serious side effects.||
5026|072|S|   This medication may raise your blood pressure. Check your||
5026|073|S|blood pressure regularly and tell your doctor if the results are||
5026|074|S|high.||
5026|075|S|   Tell your doctor right away if you have any serious side||
5026|076|S|effects, including: rectal pain/bleeding, slow/fast/irregular||
5026|077|S|heartbeat, tingling/pain/coldness in the fingers/toes, whitish||
5026|078|S|fingers/toes/nails, loss of feeling in the fingers/toes, bluish||
5026|079|S|hands/feet, muscle pain/weakness, severe stomach/abdominal pain,||
5026|080|S|lower back pain, signs of kidney problems (such as change in the||
5026|081|S|amount of urine).||
5026|082|S|   Get medical help right away if you have any very serious side||
5026|083|S|effects, including: chest pain, vision changes, confusion,||
5026|084|S|trouble speaking.||
5026|085|S|   A very serious allergic reaction to this drug is rare.||
5026|086|S|However, get medical help right away if you notice any symptoms||
5026|087|S|of a serious allergic reaction, including: rash, itching/swelling||
5026|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5026|089|S|breathing.||
5026|090|S|   This is not a complete list of possible side effects. If you||
5026|091|S|notice other effects not listed above, contact your doctor or||
5026|092|S|pharmacist.||
5026|093|S|   In the US -||
5026|094|S|   Call your doctor for medical advice about side effects. You||
5026|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5026|096|S|www.fda.gov/medwatch.||
5026|097|S|   In Canada - Call your doctor for medical advice about side||
5026|098|S|effects. You may report side effects to Health Canada at||
5026|099|S|1-866-234-2345.||
5026|100|B|||
5026|101|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
5026|102|P|pharmacist if you are allergic to ergotamine or caffeine; or to||
5026|103|P|other ergot alkaloids (such as dihydroergotamine) or to other||
5026|104|P|xanthine drugs (such as theophylline); or if you have any other||
5026|105|P|allergies. This product may contain inactive ingredients, which||
5026|106|P|can cause allergic reactions or other problems. Talk to your||
5026|107|P|pharmacist for more details.||
5026|108|P|   Before using this medication, tell your doctor or pharmacist||
5026|109|P|your medical history, especially of: blood circulation disease||
5026|110|P|(for example, peripheral vascular disease such as||
5026|111|P|arteriosclerosis, thrombophlebitis, Raynaud's disease), high||
5026|112|P|blood pressure, nutrient deficiency (malnutrition), heart/blood||
5026|113|P|vessel disease (such as coronary artery disease, stroke, heart||
5026|114|P|attack, abnormal heart rhythm), liver disease, kidney disease,||
5026|115|P|severe infection, severe itching, smoking/tobacco use, diarrhea,||
5026|116|P|diabetes, stomach problems (such as ulcers).||
5026|117|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5026|118|P|can make you more dizzy. Do not drive, use machinery, or do||
5026|119|P|anything that needs alertness until you can do it safely. Limit||
5026|120|P|alcoholic beverages. Talk to your doctor if you are using||
5026|121|P|marijuana (cannabis). Remember that alcohol may be a cause of||
5026|122|P|headaches.||
5026|123|P|   Using tobacco/nicotine products while using this medication||
5026|124|P|can increase the risk of serious side effects such as heart||
5026|125|P|problems (including chest pain, fast/slow/irregular heartbeat)||
5026|126|P|and decreased blood flow to the brain/hands/feet. Do not use||
5026|127|P|tobacco while taking this medication. If you smoke, talk to your||
5026|128|P|doctor about how to stop smoking.||
5026|129|P|   Before having surgery or certain medical procedures (such as a||
5026|130|P|heart stress test or a procedure to restore a normal heart rhythm||
5026|131|P|if you have an unusually fast heartbeat), tell your doctor or||
5026|132|P|dentist that you use this medication and about all the products||
5026|133|P|you use (including prescription drugs, nonprescription drugs, and||
5026|134|P|herbal products).||
5026|135|P|   This medication must not be used during pregnancy. It may harm||
5026|136|P|an unborn baby. Discuss the use of reliable forms of birth||
5026|137|P|control (such as condoms, birth control pills) with your doctor.||
5026|138|P|If you become pregnant or think you may be pregnant, tell your||
5026|139|P|doctor right away.||
5026|140|P|   This drug may pass into breast milk and could have undesirable||
5026|141|P|effects on a nursing infant. Breastfeeding is not recommended||
5026|142|P|while using this drug. Consult your doctor before breastfeeding.||
5026|143|B|||
5026|144|I|DRUG INTERACTIONS:  See also Warning section.||
5026|145|I|   Drug interactions may change how your medications work or||
5026|146|I|increase your risk for serious side effects. This document does||
5026|147|I|not contain all possible drug interactions. Keep a list of all||
5026|148|I|the products you use (including prescription/nonprescription||
5026|149|I|drugs and herbal products) and share it with your doctor and||
5026|150|I|pharmacist. Do not start, stop, or change the dosage of any||
5026|151|I|medicines without your doctor's approval.||
5026|152|I|   If you also take "triptan" migraine drugs (such as||
5026|153|I|sumatriptan, rizatriptan), you will need to separate your||
5026|154|I|"triptan" dose from your dose of this medication to reduce the||
5026|155|I|risk of serious side effects. Ask your doctor how long you should||
5026|156|I|wait between your doses of these drugs.||
5026|157|I|   Some products may contain caffeine or ingredients that could||
5026|158|I|raise your heart rate or blood pressure. Certain beverages (such||
5026|159|I|as coffee, colas, energy drinks) may also contain caffeine. Tell||
5026|160|I|your pharmacist what products you are using, and ask how to use||
5026|161|I|them safely (especially cough-and-cold products, bronchodilators,||
5026|162|I|stimulants, diet aids, or other headache medications).||
5026|163|I|   This medication may interfere with certain medical/lab tests||
5026|164|I|(such as dipyridamole-thallium imaging tests, urine catecholamine||
5026|165|I|levels, urine 5-HIAA levels), possibly causing false test||
5026|166|I|results. Make sure lab personnel and all your doctors know you||
5026|167|I|use this drug.||
5026|168|B|||
5026|169|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5026|170|O|has overdosed and has serious symptoms such as passing out or||
5026|171|O|trouble breathing, call 911. Otherwise, call a poison control||
5026|172|O|center right away. US residents can call 1-800-222-1222. Canada||
5026|173|O|residents can call 1-844-764-7669. Symptoms of overdose may||
5026|174|O|include: severe dizziness/drowsiness, loss of feeling in the||
5026|175|O|fingers/toes, rapid/weak heartbeat, bluish hands/feet, seizures.||
5026|176|B|||
5026|177|N|NOTES:  Do not share this medication with others.||
5026|178|N|   Certain foods/beverages or food additives (such as red wine,||
5026|179|N|cheese, chocolate, monosodium glutamate, alcohol) as well as some||
5026|180|N|lifestyle patterns (such as irregular eating/sleeping habits,||
5026|181|N|stress) may bring about a migraine headache. Avoiding these||
5026|182|N|"triggers" may help decrease the frequency of migraine headaches.||
5026|183|N|Consult your doctor for more details.||
5026|184|B|||
5026|185|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5026|186|D|If it is near the time of the next dose, skip the missed dose.||
5026|187|D|Use your next dose at the regular time. Do not double the dose to||
5026|188|D|catch up.||
5026|189|B|||
5026|190|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
5026|191|R|medications away from children and pets.||
5026|192|R|   Do not flush medications down the toilet or pour them into a||
5026|193|R|drain unless instructed to do so. Properly discard this product||
5026|194|R|when it is expired or no longer needed. Consult your pharmacist||
5026|195|R|or local waste disposal company.||
5026|196|B|||
5026|197|A|Information last revised May 2025.||
5026|198|A|Copyright(c) 2025 First Databank, Inc.||
5026|199|B|||
5030|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5030|002|Z|does NOT have all possible information about this product. This||
5030|003|Z|information does not assure that this product is safe, effective,||
5030|004|Z|or appropriate for you. This information is not individual||
5030|005|Z|medical advice and does not substitute for the advice of your||
5030|006|Z|health care professional. Always ask your health care||
5030|007|Z|professional for complete information about this product and your||
5030|008|Z|specific health needs.||
5030|009|B|||
5030|010|T|BRINZOLAMIDE SUSPENSION - OPHTHALMIC||
5030|011|F|(brin-ZOE-la-mide)||
5030|012|B|||
5030|013|C|COMMON BRAND NAME(S): Azopt||
5030|014|B|||
5030|015|U|USES:  Brinzolamide is used to treat high pressure inside the eye||
5030|016|U|due to glaucoma (open angle-type) or other eye diseases (such as||
5030|017|U|ocular hypertension). Lowering high pressure inside the eye helps||
5030|018|U|to prevent blindness. This medication works by decreasing the||
5030|019|U|amount of fluid within the eye. It belongs to a class of drugs||
5030|020|U|known as carbonic anhydrase inhibitors.||
5030|021|B|||
5030|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
5030|023|H|directed by your doctor, usually 3 times a day. Shake the bottle||
5030|024|H|well before using.||
5030|025|H|   To apply eye drops, wash your hands first. To avoid||
5030|026|H|contamination, do not touch the dropper tip or let it touch your||
5030|027|H|eye or any other surface.||
5030|028|H|   The preservative in this product may be absorbed by contact||
5030|029|H|lenses. If you wear contact lenses, remove them before using your||
5030|030|H|eye drops. Wait at least 15 minutes after each dose before||
5030|031|H|putting your lenses back in.||
5030|032|H|   Tilt your head back, look upward, and pull down the lower||
5030|033|H|eyelid to make a pouch. Hold the dropper directly over your eye||
5030|034|H|and place one drop into the pouch. Look downward and gently close||
5030|035|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
5030|036|H|your eye (near the nose) and apply gentle pressure. This will||
5030|037|H|prevent the medication from draining out. Try not to blink and do||
5030|038|H|not rub your eye. Repeat these steps for your other eye if so||
5030|039|H|directed.||
5030|040|H|   Do not rinse the dropper. Replace the dropper cap after each||
5030|041|H|use.||
5030|042|H|   If you are using another kind of eye medication (such as drops||
5030|043|H|or ointments), wait at least 10 minutes before applying other||
5030|044|H|medications. Use eye drops before eye ointments to allow the eye||
5030|045|H|drops to enter the eye.||
5030|046|H|   Wait several minutes for your vision to clear before driving||
5030|047|H|or operating machinery.||
5030|048|H|   Use this medication regularly in order to get the most benefit||
5030|049|H|from it. Remember to use it at the same times each day. Keep||
5030|050|H|using brinzolamide even if you feel well. Most people with||
5030|051|H|glaucoma or high pressure in the eye do not feel sick.||
5030|052|B|||
5030|053|S|SIDE EFFECTS:  Temporary blurred vision, bitter/sour/unusual||
5030|054|S|taste in your mouth, dry eyes, temporary||
5030|055|S|discomfort/itching/redness of the eye, feeling as if something is||
5030|056|S|in your eye, eye discharge, and headache may occur. If any of||
5030|057|S|these effects last or get worse, notify your doctor or pharmacist||
5030|058|S|promptly.||
5030|059|S|   Remember that this medication has been prescribed because your||
5030|060|S|doctor has judged that the benefit to you is greater than the||
5030|061|S|risk of side effects. Many people using this medication do not||
5030|062|S|have serious side effects.||
5030|063|S|   Tell your doctor right away if you have any serious side||
5030|064|S|effects, including: nausea or vomiting that doesn't stop, eye or||
5030|065|S|eyelid swelling/pain, stomach/side/back pain, yellowing||
5030|066|S|eyes/skin, dark urine, easy bruising or bleeding, unusual||
5030|067|S|tiredness, signs of infection (such as sore throat that doesn't||
5030|068|S|go away, fever, chills).||
5030|069|S|   A very serious allergic reaction to this drug is rare.||
5030|070|S|However, get medical help right away if you notice any symptoms||
5030|071|S|of a serious allergic reaction, including: rash, itching/swelling||
5030|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5030|073|S|breathing.||
5030|074|S|   This is not a complete list of possible side effects. If you||
5030|075|S|notice other effects not listed above, contact your doctor or||
5030|076|S|pharmacist.||
5030|077|S|   In the US -||
5030|078|S|   Call your doctor for medical advice about side effects. You||
5030|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5030|080|S|www.fda.gov/medwatch.||
5030|081|S|   In Canada - Call your doctor for medical advice about side||
5030|082|S|effects. You may report side effects to Health Canada at||
5030|083|S|1-866-234-2345.||
5030|084|B|||
5030|085|P|PRECAUTIONS:  Before using brinzolamide, tell your doctor or||
5030|086|P|pharmacist if you are allergic to it; or if you have any other||
5030|087|P|allergies. This product may contain inactive ingredients, which||
5030|088|P|can cause allergic reactions or other problems. Talk to your||
5030|089|P|pharmacist for more details.||
5030|090|P|   Before using this medication, tell your doctor or pharmacist||
5030|091|P|your medical history, especially of: other eye conditions, kidney||
5030|092|P|problems, liver disease.||
5030|093|P|   If you develop an eye infection or injury, or have eye||
5030|094|P|surgery, check with your doctor about whether you should continue||
5030|095|P|to use your current bottle of brinzolamide. You may be advised to||
5030|096|P|start using a new bottle.||
5030|097|P|   Before having surgery, tell your doctor or dentist about all||
5030|098|P|the products you use (including prescription drugs,||
5030|099|P|nonprescription drugs, and herbal products).||
5030|100|P|   After you apply this drug, your vision may become temporarily||
5030|101|P|blurred or unstable. Do not drive, use machinery, or do anything||
5030|102|P|that needs clear vision until you can do it safely.||
5030|103|P|   During pregnancy, this medication should be used only when||
5030|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
5030|105|P|   It is unknown if this drug passes into breast milk. Consult||
5030|106|P|your doctor before breastfeeding.||
5030|107|B|||
5030|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5030|109|I|medications work or increase your risk for serious side effects.||
5030|110|I|This document does not contain all possible drug interactions.||
5030|111|I|Keep a list of all the products you use (including||
5030|112|I|prescription/nonprescription drugs and herbal products) and share||
5030|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
5030|114|I|the dosage of any medicines without your doctor's approval.||
5030|115|B|||
5030|116|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5030|117|O|has overdosed and has serious symptoms such as passing out or||
5030|118|O|trouble breathing, call 911. Otherwise, call a poison control||
5030|119|O|center right away. US residents can call 1-800-222-1222. Canada||
5030|120|O|residents can call 1-844-764-7669.||
5030|121|B|||
5030|122|N|NOTES:  Do not share this medication with others.||
5030|123|N|   Lab and/or medical tests (such as eye exams) should be done||
5030|124|N|while you are using this medication. Keep all medical and lab||
5030|125|N|appointments. Consult your doctor for more details.||
5030|126|B|||
5030|127|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5030|128|D|If it is near the time of the next dose, skip the missed dose.||
5030|129|D|Use your next dose at the regular time. Do not double the dose to||
5030|130|D|catch up.||
5030|131|B|||
5030|132|R|STORAGE:  Store at room temperature or in the refrigerator. Keep||
5030|133|R|all medications away from children and pets.||
5030|134|R|   Do not flush medications down the toilet or pour them into a||
5030|135|R|drain unless instructed to do so. Properly discard this product||
5030|136|R|when it is expired or no longer needed. Consult your pharmacist||
5030|137|R|or local waste disposal company.||
5030|138|B|||
5030|139|A|Information last revised May 2024.||
5030|140|A|Copyright(c) 2025 First Databank, Inc.||
5030|141|B|||
5032|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5032|002|Z|does NOT have all possible information about this product. This||
5032|003|Z|information does not assure that this product is safe, effective,||
5032|004|Z|or appropriate for you. This information is not individual||
5032|005|Z|medical advice and does not substitute for the advice of your||
5032|006|Z|health care professional. Always ask your health care||
5032|007|Z|professional for complete information about this product and your||
5032|008|Z|specific health needs.||
5032|009|B|||
5032|010|T|PILOCARPINE SOLUTION - OPHTHALMIC||
5032|011|F|(PYE-loe-KAR-peen)||
5032|012|B|||
5032|013|C|COMMON BRAND NAME(S): Isopto Carpine, Pilocar||
5032|014|B|||
5032|015|U|USES:  This medication is used alone or with other medications to||
5032|016|U|treat high pressure inside the eye due to glaucoma or other eye||
5032|017|U|diseases (such as ocular hypertension). Lowering high pressure||
5032|018|U|inside the eye helps to prevent blindness, vision loss, and nerve||
5032|019|U|damage. This medication may also be used during certain eye||
5032|020|U|surgeries and to reverse the effects of drugs used to enlarge the||
5032|021|U|pupil (such as during an eye exam). Pilocarpine works by causing||
5032|022|U|the pupil of the eye to shrink and decreasing the amount of fluid||
5032|023|U|within the eye.||
5032|024|B|||
5032|025|H|HOW TO USE:  Use this medication in the affected eye(s) as||
5032|026|H|directed by your doctor, usually 3 to 4 times a day.||
5032|027|H|   To apply eye drops, wash your hands first. To avoid||
5032|028|H|contamination, do not touch the dropper tip or let it touch your||
5032|029|H|eye or any other surface.||
5032|030|H|   If you are wearing contact lenses, remove them before using||
5032|031|H|eye drops. Wait at least 10 minutes before replacing your contact||
5032|032|H|lenses.||
5032|033|H|   Tilt your head back, look upward, and pull down the lower||
5032|034|H|eyelid to make a pouch. Hold the dropper directly over your eye||
5032|035|H|and place one drop into the pouch. Let go of the eyelid and||
5032|036|H|gently close your eyes. Place one finger at the corner of your||
5032|037|H|eye (near the nose) and apply gentle pressure for 1 to 2 minutes.||
5032|038|H|This will prevent the medication from draining out. Try not to||
5032|039|H|blink and do not rub your eye. Repeat these steps for your other||
5032|040|H|eye if so directed or if your dose is for more than 1 drop.||
5032|041|H|   Remove extra solution around the eye with a tissue and wash||
5032|042|H|your hands to remove any medicine that may be on them. Do not||
5032|043|H|rinse the dropper. Replace the dropper cap after each use.||
5032|044|H|   If you are using another kind of eye medication (such as drops||
5032|045|H|or ointments), wait at least 5 minutes before using the other||
5032|046|H|medication. Use eye drops before ointments to allow the eye drops||
5032|047|H|to enter the eye.||
5032|048|H|   Wait several minutes for your vision to clear before driving||
5032|049|H|or operating machinery.||
5032|050|H|   If your doctor has prescribed this medication to treat||
5032|051|H|glaucoma or high pressure in the eyes, use it regularly in order||
5032|052|H|to get the most benefit from it. Most people with glaucoma or||
5032|053|H|high pressure in the eyes do not have any symptoms. To help you||
5032|054|H|remember, use it at the same time(s) each day.||
5032|055|B|||
5032|056|S|SIDE EFFECTS:  Temporary irritation/burning/stinging of the eye,||
5032|057|S|temporary blurred vision, poor vision in dim light, headache, or||
5032|058|S|brow ache may occur. If any of these effects last or get worse,||
5032|059|S|tell your doctor or pharmacist promptly.||
5032|060|S|   Remember that this medication has been prescribed because your||
5032|061|S|doctor has judged that the benefit to you is greater than the||
5032|062|S|risk of side effects. Many people using this medication do not||
5032|063|S|have serious side effects.||
5032|064|S|   Tell your doctor right away if you have any serious side||
5032|065|S|effects, including: eye pain, vision changes (such as seeing||
5032|066|S|floaters/flashes of light).||
5032|067|S|   A very serious allergic reaction to this drug is rare.||
5032|068|S|However, get medical help right away if you notice any symptoms||
5032|069|S|of a serious allergic reaction, including: rash, itching/swelling||
5032|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5032|071|S|breathing.||
5032|072|S|   This is not a complete list of possible side effects. If you||
5032|073|S|notice other effects not listed above, contact your doctor or||
5032|074|S|pharmacist.||
5032|075|S|   In the US -||
5032|076|S|   Call your doctor for medical advice about side effects. You||
5032|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5032|078|S|www.fda.gov/medwatch.||
5032|079|S|   In Canada - Call your doctor for medical advice about side||
5032|080|S|effects. You may report side effects to Health Canada at||
5032|081|S|1-866-234-2345.||
5032|082|B|||
5032|083|P|PRECAUTIONS:  Before using pilocarpine, tell your doctor or||
5032|084|P|pharmacist if you are allergic to it; or to preservatives (such||
5032|085|P|as benzalkonium chloride); or if you have any other allergies.||
5032|086|P|This product may contain inactive ingredients, which can cause||
5032|087|P|allergic reactions or other problems. Talk to your pharmacist for||
5032|088|P|more details.||
5032|089|P|   Before using this medication, tell your doctor or pharmacist||
5032|090|P|your medical history, especially of: other eye problems (such as||
5032|091|P|iritis, detached retina).||
5032|092|P|   After you apply this drug, your vision may become temporarily||
5032|093|P|blurred. Vision in dim light may be affected. Do not drive||
5032|094|P|(especially at night), use machinery, or do anything that needs||
5032|095|P|clear vision until you can do it safely.||
5032|096|P|   Before having surgery, tell your doctor or dentist about all||
5032|097|P|the products you use (including prescription drugs,||
5032|098|P|nonprescription drugs, and herbal products).||
5032|099|P|   During pregnancy, this drug should be used only when clearly||
5032|100|P|needed. Discuss the risks and benefits with your doctor.||
5032|101|P|   It is unknown if this medication passes into breast milk.||
5032|102|P|Consult your doctor before breastfeeding.||
5032|103|B|||
5032|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5032|105|I|medications work or increase your risk for serious side effects.||
5032|106|I|This document does not contain all possible drug interactions.||
5032|107|I|Keep a list of all the products you use (including||
5032|108|I|prescription/nonprescription drugs and herbal products) and share||
5032|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
5032|110|I|the dosage of any medicines without your doctor's approval.||
5032|111|B|||
5032|112|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5032|113|O|has overdosed and has serious symptoms such as passing out or||
5032|114|O|trouble breathing, call 911. Otherwise, call a poison control||
5032|115|O|center right away. US residents can call 1-800-222-1222. Canada||
5032|116|O|residents can call 1-844-764-7669. Symptoms of overdose may||
5032|117|O|include: increased saliva or sweating, tremors, slow heartbeat,||
5032|118|O|dizziness.||
5032|119|B|||
5032|120|N|NOTES:  Do not share this medication with others.||
5032|121|N|   Lab and/or medical tests (such as eye exams) should be done||
5032|122|N|while you are using this medication. Keep all medical and lab||
5032|123|N|appointments. Consult your doctor for more details.||
5032|124|B|||
5032|125|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
5032|126|D|remember. If it is near the time of the next dose, skip the||
5032|127|D|missed dose. Use your next dose at the regular time. Do not||
5032|128|D|double the dose to catch up.||
5032|129|B|||
5032|130|R|STORAGE:  Different brands of this medication have different||
5032|131|R|storage needs. Check the product package for instructions on how||
5032|132|R|to store your brand, or ask your pharmacist. Keep all medications||
5032|133|R|away from children and pets.||
5032|134|R|   If you are using the single-use containers, discard any unused||
5032|135|R|medication immediately after use.||
5032|136|R|   Do not flush medications down the toilet or pour them into a||
5032|137|R|drain unless instructed to do so. Properly discard this product||
5032|138|R|when it is expired or no longer needed. Consult your pharmacist||
5032|139|R|or local waste disposal company.||
5032|140|B|||
5032|141|A|Information last revised January 2025.||
5032|142|A|Copyright(c) 2025 First Databank, Inc.||
5032|143|B|||
5034|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5034|002|Z|does NOT have all possible information about this product. This||
5034|003|Z|information does not assure that this product is safe, effective,||
5034|004|Z|or appropriate for you. This information is not individual||
5034|005|Z|medical advice and does not substitute for the advice of your||
5034|006|Z|health care professional. Always ask your health care||
5034|007|Z|professional for complete information about this product and your||
5034|008|Z|specific health needs.||
5034|009|B|||
5034|010|T|MOLINDONE - ORAL||
5034|011|F|(moe-LIN-done)||
5034|012|B|||
5034|013|C|COMMON BRAND NAME(S): Moban||
5034|014|B|||
5034|015|W|WARNING:  There may be a slightly increased risk of serious,||
5034|016|W|possibly fatal side effects (such as heart failure,||
5034|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
5034|018|W|by older adults with dementia. This medication is not approved||
5034|019|W|for the treatment of dementia-related behavior problems. Discuss||
5034|020|W|the risks and benefits of this medication, as well as other||
5034|021|W|effective and possibly safer treatments for dementia-related||
5034|022|W|behavior problems, with the doctor.||
5034|023|B|||
5034|024|U|USES:  This medication is used to treat certain mental/mood||
5034|025|U|disorders (such as schizophrenia). Molindone belongs to a class||
5034|026|U|of drugs known as antipsychotics. It works by helping to restore||
5034|027|U|the balance of certain natural substances in the brain.||
5034|028|B|||
5034|029|H|HOW TO USE:  Take this medication by mouth with or without food||
5034|030|H|as directed by your doctor, usually 1 to 4 times daily.||
5034|031|H|   The dosage is based on your medical condition and response to||
5034|032|H|treatment. To reduce your risk of side effects such as drowsiness||
5034|033|H|and shaking (tremor), your doctor may direct you to start this||
5034|034|H|medication at a low dose and gradually increase your dose. Follow||
5034|035|H|your doctor's directions carefully.||
5034|036|H|   Molindone tablets contain a small amount of calcium, which can||
5034|037|H|interfere with your body's ability to absorb certain drugs,||
5034|038|H|especially if you take them around the same time. Examples of||
5034|039|H|these drugs include quinolone antibiotics (such as ciprofloxacin,||
5034|040|H|levofloxacin), tetracycline antibiotics (such as doxycycline,||
5034|041|H|minocycline), levodopa, phenytoin, thyroid medications (such as||
5034|042|H|levothyroxine), and drugs for osteoporosis (bisphosphonates such||
5034|043|H|as alendronate). Ask your doctor or pharmacist how long to wait||
5034|044|H|between doses and when you should take your medications.||
5034|045|H|   Take this medication regularly to get the most benefit from||
5034|046|H|it. To help you remember, take it at the same time(s) each day.||
5034|047|H|Do not stop taking this medication without consulting your||
5034|048|H|doctor. Your condition may become worse when this drug is||
5034|049|H|suddenly stopped. Your doctor may reduce your dose gradually.||
5034|050|H|   Although you may notice some improvement in your symptoms soon||
5034|051|H|after starting this medication, it may take several weeks to||
5034|052|H|months before you get the full benefit of this drug.||
5034|053|H|   Tell your doctor if your condition does not get better or if||
5034|054|H|it gets worse.||
5034|055|B|||
5034|056|S|SIDE EFFECTS:  See also Warning section.||
5034|057|S|   Drowsiness, dizziness, lightheadedness, constipation, dry||
5034|058|S|mouth, or blurred vision may occur. If any of these effects last||
5034|059|S|or get worse, tell your doctor or pharmacist promptly.||
5034|060|S|   Dizziness and lightheadedness can increase the risk of||
5034|061|S|falling. Get up slowly when rising from a sitting or lying||
5034|062|S|position.||
5034|063|S|   Tell your doctor right away if any of these side effects||
5034|064|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
5034|065|S|mask-like expression of the face, drooling/trouble swallowing, or||
5034|066|S|shuffling walk. Your doctor may prescribe another medication to||
5034|067|S|decrease these side effects.||
5034|068|S|   Remember that this medication has been prescribed because your||
5034|069|S|doctor has judged that the benefit to you is greater than the||
5034|070|S|risk of side effects. Many people using this medication do not||
5034|071|S|have serious side effects.||
5034|072|S|   Tell your doctor right away if you have any serious side||
5034|073|S|effects, including: depression/suicidal thoughts, fainting,||
5034|074|S|difficulty urinating, signs of infection (such as sore throat||
5034|075|S|that doesn't go away, fever, chills), symptoms of liver disease||
5034|076|S|(such as nausea/vomiting that doesn't stop, loss of appetite,||
5034|077|S|yellowing eyes/skin), severe stomach/abdominal pain.||
5034|078|S|   This medication may cause a condition called tardive||
5034|079|S|dyskinesia. In some cases, this condition may be permanent. Tell||
5034|080|S|your doctor right away if you develop any unusual uncontrolled||
5034|081|S|movements (especially of the face, mouth, tongue, arms, or legs).||
5034|082|S|   In rare cases, molindone may increase your level of a certain||
5034|083|S|chemical made by the body (prolactin). For females, this increase||
5034|084|S|in prolactin may result in unwanted breast milk, missed/stopped||
5034|085|S|periods, or difficulty becoming pregnant. For males, it may||
5034|086|S|result in decreased sexual ability, inability to produce sperm,||
5034|087|S|or enlarged breasts. If you develop any of these symptoms, tell||
5034|088|S|your doctor right away.||
5034|089|S|   Rarely, males may have a painful or prolonged erection lasting||
5034|090|S|4 or more hours. If this occurs, stop using this drug and get||
5034|091|S|medical help right away, or permanent problems could occur.||
5034|092|S|   Get medical help right away if you have any very serious side||
5034|093|S|effects, including: seizures.||
5034|094|S|   This medication may rarely cause a very serious condition||
5034|095|S|called neuroleptic malignant syndrome (NMS). Get medical help||
5034|096|S|right away if you have any of the following symptoms: fever,||
5034|097|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
5034|098|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
5034|099|S|signs of kidney problems (such as change in the amount of urine).||
5034|100|S|   A very serious allergic reaction to this drug is rare.||
5034|101|S|However, get medical help right away if you notice any symptoms||
5034|102|S|of a serious allergic reaction, including: rash, itching/swelling||
5034|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5034|104|S|breathing.||
5034|105|S|   This is not a complete list of possible side effects. If you||
5034|106|S|notice other effects not listed above, contact your doctor or||
5034|107|S|pharmacist.||
5034|108|S|   In the US -||
5034|109|S|   Call your doctor for medical advice about side effects. You||
5034|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5034|111|S|www.fda.gov/medwatch.||
5034|112|S|   In Canada - Call your doctor for medical advice about side||
5034|113|S|effects. You may report side effects to Health Canada at||
5034|114|S|1-866-234-2345.||
5034|115|B|||
5034|116|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
5034|117|P|pharmacist if you are allergic to it; or if you have any other||
5034|118|P|allergies. This product may contain inactive ingredients, which||
5034|119|P|can cause allergic reactions or other problems. Talk to your||
5034|120|P|pharmacist for more details.||
5034|121|P|   Before using this medication, tell your doctor or pharmacist||
5034|122|P|your medical history, especially of: blood problems (such as a||
5034|123|P|low white blood cell count), a certain eye condition (glaucoma),||
5034|124|P|heart problems (such as slow/fast/irregular heartbeat, low blood||
5034|125|P|pressure), slow movement of the gut/intestines (such as chronic||
5034|126|P|constipation, blockage), liver disease, brain||
5034|127|P|disorder/tumor/injury, drug/alcohol/substance abuse, breast||
5034|128|P|cancer, Parkinson's disease, a certain severe reaction to other||
5034|129|P|antipsychotic-type medications (neuroleptic malignant||
5034|130|P|syndrome-NMS), difficulty urinating (such as due to prostate||
5034|131|P|problems).||
5034|132|P|   This drug may make you dizzy or drowsy or blur your vision.||
5034|133|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
5034|134|P|drowsy. Do not drive, use machinery, or do anything that needs||
5034|135|P|alertness or clear vision until you can do it safely. Limit||
5034|136|P|alcoholic beverages. Talk to your doctor if you are using||
5034|137|P|marijuana (cannabis).||
5034|138|P|   Before having surgery, tell your doctor or dentist about all||
5034|139|P|the products you use (including prescription drugs,||
5034|140|P|nonprescription drugs, and herbal products).||
5034|141|P|   Molindone may make you sweat less, making you more likely to||
5034|142|P|get heat stroke. Avoid doing things that may cause you to||
5034|143|P|overheat, such as hard work or exercise in hot weather, or using||
5034|144|P|hot tubs. When the weather is hot, drink a lot of fluids and||
5034|145|P|dress lightly. If you overheat, quickly look for a place to cool||
5034|146|P|down and rest. Get medical help right away if you have a fever||
5034|147|P|that does not go away, mental/mood changes, headache, or||
5034|148|P|dizziness.||
5034|149|P|   Older adults may be more sensitive to the side effects of this||
5034|150|P|drug, especially drowsiness, dizziness, lightheadedness, muscle||
5034|151|P|spasm/stiffness, and uncontrolled movements (tardive dyskinesia).||
5034|152|P|Drowsiness, dizziness, and lightheadedness can increase the risk||
5034|153|P|of falling.||
5034|154|P|   During pregnancy, this medication should be used only when||
5034|155|P|clearly needed. Babies born to mothers who have used this drug||
5034|156|P|during the last 3 months of pregnancy may rarely develop symptoms||
5034|157|P|including muscle stiffness or shakiness, drowsiness,||
5034|158|P|feeding/breathing difficulties, or constant crying. If you notice||
5034|159|P|any of these symptoms in your newborn, especially during their||
5034|160|P|first month, tell the doctor right away.||
5034|161|P|   Since untreated mental/mood problems (such as schizophrenia)||
5034|162|P|can be a serious condition, do not stop taking this medication||
5034|163|P|unless directed by your doctor. If you are planning pregnancy,||
5034|164|P|become pregnant, or think you may be pregnant, discuss with your||
5034|165|P|doctor right away the benefits and risks of using this medication||
5034|166|P|during pregnancy.||
5034|167|P|   It is unknown if this drug passes into breast milk. Consult||
5034|168|P|your doctor before breastfeeding.||
5034|169|B|||
5034|170|I|DRUG INTERACTIONS:  See also How to Use section.||
5034|171|I|   Drug interactions may change how your medications work or||
5034|172|I|increase your risk for serious side effects. This document does||
5034|173|I|not contain all possible drug interactions. Keep a list of all||
5034|174|I|the products you use (including prescription/nonprescription||
5034|175|I|drugs and herbal products) and share it with your doctor and||
5034|176|I|pharmacist. Do not start, stop, or change the dosage of any||
5034|177|I|medicines without your doctor's approval.||
5034|178|I|   Tell your doctor or pharmacist if you are taking other||
5034|179|I|products that cause drowsiness such as opioid pain or cough||
5034|180|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5034|181|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5034|182|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5034|183|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5034|184|I|diphenhydramine).||
5034|185|I|   Check the labels on all your medicines (such as allergy or||
5034|186|I|cough-and-cold products) because they may contain ingredients||
5034|187|I|that cause drowsiness. Ask your pharmacist about using those||
5034|188|I|products safely.||
5034|189|B|||
5034|190|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5034|191|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5034|192|O|poison control center right away. US residents can call||
5034|193|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5034|194|O|Symptoms of overdose may include: slow/shallow breathing,||
5034|195|O|inability to wake up (coma).||
5034|196|B|||
5034|197|N|NOTES:  Do not share this medication with others.||
5034|198|N|   Lab and/or medical tests may be done while you are taking this||
5034|199|N|medication. Keep all medical and lab appointments.||
5034|200|B|||
5034|201|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5034|202|D|remember. If it is near the time of the next dose, skip the||
5034|203|D|missed dose. Take your next dose at the regular time. Do not||
5034|204|D|double the dose to catch up.||
5034|205|B|||
5034|206|R|STORAGE:  Store at room temperature away from light and moisture.||
5034|207|R|Do not store in the bathroom. Keep all medications away from||
5034|208|R|children and pets.||
5034|209|R|   Do not flush medications down the toilet or pour them into a||
5034|210|R|drain unless instructed to do so. Properly discard this product||
5034|211|R|when it is expired or no longer needed. Consult your pharmacist||
5034|212|R|or local waste disposal company.||
5034|213|B|||
5034|214|A|Information last revised May 2025.||
5034|215|A|Copyright(c) 2025 First Databank, Inc.||
5034|216|B|||
5037|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5037|002|Z|does NOT have all possible information about this product. This||
5037|003|Z|information does not assure that this product is safe, effective,||
5037|004|Z|or appropriate for you. This information is not individual||
5037|005|Z|medical advice and does not substitute for the advice of your||
5037|006|Z|health care professional. Always ask your health care||
5037|007|Z|professional for complete information about this product and your||
5037|008|Z|specific health needs.||
5037|009|B|||
5037|010|T|INSULIN ASPART PROTAMINE/INSULIN ASPART - INJECTION||
5037|011|F|(IN-sue-lin AS-part PRO-tah-meen/ IN-sue-lin AS-part)||
5037|012|B|||
5037|013|C|COMMON BRAND NAME(S): Novolog Mix||
5037|014|B|||
5037|015|U|USES:  Insulin aspart protamine/insulin aspart is used along with||
5037|016|U|a proper diet and exercise program to control high blood sugar in||
5037|017|U|people with diabetes. This product is a combination of two||
5037|018|U|man-made insulins: intermediate-acting insulin aspart protamine||
5037|019|U|and rapid-acting insulin aspart. This combination starts working||
5037|020|U|faster and lasts for a longer time than regular insulin.||
5037|021|U|   Insulin is a natural substance that allows the body to||
5037|022|U|properly use sugar from the diet. It replaces the insulin that||
5037|023|U|your body no longer produces, thereby lowering your blood sugar.||
5037|024|U|Controlling high blood sugar helps prevent kidney damage,||
5037|025|U|blindness, nerve problems, loss of limbs, and sexual function||
5037|026|U|problems. Proper control of diabetes may also lessen your risk of||
5037|027|U|a heart attack or stroke.||
5037|028|B|||
5037|029|H|HOW TO USE:  Read the Patient Information Leaflet and||
5037|030|H|Instructions for Use if available from your pharmacist before you||
5037|031|H|start using this medication and each time you get a refill. Ask||
5037|032|H|your health care professional how to prepare and use this||
5037|033|H|medication. If you have any questions, ask your doctor or||
5037|034|H|pharmacist.||
5037|035|H|   Inject this medication under the skin as directed by your||
5037|036|H|doctor, usually twice daily (15 minutes or less before the||
5037|037|H|morning and evening meal). Because this product contains a||
5037|038|H|short-acting insulin, not eating right after a dose of this||
5037|039|H|insulin may lead to low blood sugar (hypoglycemia). The injection||
5037|040|H|is given in the stomach area, the thigh, the buttocks, or the||
5037|041|H|back of the upper arm. Do not inject into a vein or muscle||
5037|042|H|because very low blood sugar may occur.||
5037|043|H|   The dosage is based on your medical condition and response to||
5037|044|H|treatment. Measure each dose very carefully because even small||
5037|045|H|changes in the amount of insulin may have a large effect on your||
5037|046|H|blood sugar.||
5037|047|H|   Before using, gently roll and turn the vial between your palms||
5037|048|H|at least 10 times. If using a cartridge or pen, turn it upside||
5037|049|H|down and right side up so that the glass ball moves from one end||
5037|050|H|to the other for at least 10 times. Do not shake the container.||
5037|051|H|Check this product for particles or discoloration. If either is||
5037|052|H|present, do not use the insulin. This product should look evenly||
5037|053|H|cloudy/milky after mixing. Do not use if you see clumps of white||
5037|054|H|material, a "frosty" appearance, or particles stuck to the sides||
5037|055|H|of the product.||
5037|056|H|   Before injecting each dose, clean the skin you are going to||
5037|057|H|inject into (the injection site) with rubbing alcohol. Change the||
5037|058|H|injection site each time to lessen injury under the skin (for||
5037|059|H|example, pits/lumps or thickened skin). Do not inject into skin||
5037|060|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
5037|061|H|not rub the injection site after a shot. Do not inject cold||
5037|062|H|insulin because this can be painful. The insulin container you||
5037|063|H|are currently using can be kept at room temperature. Learn how to||
5037|064|H|store and discard medical supplies safely.||
5037|065|H|   Do not mix this product with other insulins or use it in an||
5037|066|H|insulin pump.||
5037|067|H|   Do not change brands or types of insulin without directions on||
5037|068|H|how to do so from your doctor.||
5037|069|H|   Do not share your pen device with another person, even if the||
5037|070|H|needle is changed. You may give other people a serious infection,||
5037|071|H|or get a serious infection from them.||
5037|072|H|   Use this medication regularly to get the most benefit from it.||
5037|073|H|To help you remember, use it at the same times each day.||
5037|074|H|   Tell your doctor if your condition does not get better or if||
5037|075|H|it gets worse (your blood sugar is too high or too low).||
5037|076|B|||
5037|077|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
5037|078|S|irritation) or weight gain may occur. If any of these effects||
5037|079|S|last or get worse, tell your doctor or pharmacist promptly.||
5037|080|S|   Remember that this medication has been prescribed because your||
5037|081|S|doctor has judged that the benefit to you is greater than the||
5037|082|S|risk of side effects. Many people using this medication do not||
5037|083|S|have serious side effects.||
5037|084|S|   Tell your doctor right away if you have any serious side||
5037|085|S|effects, including: signs of low potassium level in the blood||
5037|086|S|(such as muscle cramps, weakness, irregular heartbeat).||
5037|087|S|   This medication can cause low blood sugar (hypoglycemia). This||
5037|088|S|may occur if you do not get enough calories from food or if you||
5037|089|S|do unusually heavy exercise. Symptoms of low blood sugar include||
5037|090|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
5037|091|S|dizziness, or tingling hands/feet. It is a good habit to carry||
5037|092|S|glucose tablets or gel to treat low blood sugar. If you don't||
5037|093|S|have these reliable forms of glucose, rapidly raise your blood||
5037|094|S|sugar by eating a quick source of sugar such as table sugar,||
5037|095|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
5037|096|S|doctor right away about the reaction and the use of this product.||
5037|097|S|To help prevent low blood sugar, eat meals on a regular schedule,||
5037|098|S|and do not skip meals. Check with your doctor or pharmacist to||
5037|099|S|find out what you should do if you miss a meal.||
5037|100|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
5037|101|S|thirst/urination. If these symptoms occur, tell your doctor right||
5037|102|S|away. Your doctor may need to adjust your diabetes medication,||
5037|103|S|exercise program, or diet.||
5037|104|S|   A very serious allergic reaction to this drug is rare.||
5037|105|S|However, get medical help right away if you notice any symptoms||
5037|106|S|of a serious allergic reaction, including: rash, itching/swelling||
5037|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5037|108|S|breathing.||
5037|109|S|   This is not a complete list of possible side effects. If you||
5037|110|S|notice other effects not listed above, contact your doctor or||
5037|111|S|pharmacist.||
5037|112|S|   In the US -||
5037|113|S|   Call your doctor for medical advice about side effects. You||
5037|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5037|115|S|www.fda.gov/medwatch.||
5037|116|S|   In Canada - Call your doctor for medical advice about side||
5037|117|S|effects. You may report side effects to Health Canada at||
5037|118|S|1-866-234-2345.||
5037|119|B|||
5037|120|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
5037|121|P|pharmacist if you are allergic to it; or to other insulins; or if||
5037|122|P|you have any other allergies. This product may contain inactive||
5037|123|P|ingredients, which can cause allergic reactions or other||
5037|124|P|problems. Talk to your pharmacist for more details.||
5037|125|P|   Before using this medication, tell your doctor or pharmacist||
5037|126|P|your medical history, especially of: kidney disease, liver||
5037|127|P|disease.||
5037|128|P|   Do not use this medication when you have low blood sugar.||
5037|129|P|   You may experience blurred vision, dizziness, or drowsiness||
5037|130|P|due to extremely low or high blood sugar. Do not drive, use||
5037|131|P|machinery, or do anything that needs alertness or clear vision||
5037|132|P|until you can do it safely.||
5037|133|P|   Limit alcohol while taking this medication because it can||
5037|134|P|increase the risk of developing low blood sugar.||
5037|135|P|   It may be harder to control your blood sugar when your body is||
5037|136|P|stressed (such as due to fever, infection, injury, or surgery).||
5037|137|P|Consult your doctor because this may require a change in your||
5037|138|P|treatment plan, medications, or blood sugar testing.||
5037|139|P|   Before having surgery, tell your doctor or dentist about all||
5037|140|P|the products you use (including prescription drugs,||
5037|141|P|nonprescription drugs, and herbal products).||
5037|142|P|   Check your blood sugar before and after exercise. You may need||
5037|143|P|a snack before exercising.||
5037|144|P|   If traveling across more than two time zones, ask your doctor||
5037|145|P|about how to adjust your insulin schedule.||
5037|146|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
5037|147|P|cause or worsen diabetes. Discuss a plan with your doctor for||
5037|148|P|managing your blood sugar while pregnant. Your doctor may change||
5037|149|P|your diabetes treatment during your pregnancy (such as diet and||
5037|150|P|medications including insulin).||
5037|151|P|   This medication passes into breast milk, but is unlikely to||
5037|152|P|harm a nursing infant. Consult your doctor before breastfeeding.||
5037|153|P|Your insulin needs may change while breastfeeding.||
5037|154|B|||
5037|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5037|156|I|medications work or increase your risk for serious side effects.||
5037|157|I|This document does not contain all possible drug interactions.||
5037|158|I|Keep a list of all the products you use (including||
5037|159|I|prescription/nonprescription drugs and herbal products) and share||
5037|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
5037|161|I|the dosage of any medicines without your doctor's approval.||
5037|162|I|   Beta-blocker medications (such as metoprolol, propranolol,||
5037|163|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
5037|164|I|heartbeat you would usually feel when your blood sugar falls too||
5037|165|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
5037|166|I|dizziness, hunger, or sweating are unaffected by these drugs.||
5037|167|I|   Many drugs can affect your blood sugar, making it harder to||
5037|168|I|control. Before you start, stop, or change any medication, talk||
5037|169|I|with your doctor or pharmacist about how the medication may||
5037|170|I|affect your blood sugar. Check your blood sugar regularly as||
5037|171|I|directed and share the results with your doctor. Tell your doctor||
5037|172|I|right away if you have symptoms of high or low blood sugar. (See||
5037|173|I|also Side Effects section.) Your doctor may need to adjust your||
5037|174|I|diabetes medication, exercise program, or diet.||
5037|175|B|||
5037|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5037|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5037|178|O|poison control center right away. US residents can call||
5037|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5037|180|O|Symptoms of overdose may include: very fast heartbeat, vision||
5037|181|O|changes, unexplained heavy sweating, agitation, fainting,||
5037|182|O|seizures.||
5037|183|B|||
5037|184|N|NOTES:  Do not share this medication, needles, or syringes with||
5037|185|N|others.||
5037|186|N|   Attend a diabetes education program to learn more about how to||
5037|187|N|manage your diabetes with medications, diet, exercise, and||
5037|188|N|regular medical exams.||
5037|189|N|   Learn the symptoms of high and low blood sugar and how to||
5037|190|N|treat low blood sugar. Check your blood sugar regularly as||
5037|191|N|directed and share the results with your doctor.||
5037|192|N|   Lab and/or medical tests (such as fasting blood glucose,||
5037|193|N|hemoglobin A1c) should be done while you are taking this||
5037|194|N|medication. Keep all medical and lab appointments.||
5037|195|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
5037|196|B|||
5037|197|D|MISSED DOSE:  It is very important to follow your insulin regimen||
5037|198|D|exactly. Ask your doctor ahead of time what you should do if you||
5037|199|D|miss a dose of insulin.||
5037|200|B|||
5037|201|R|STORAGE:  Different brands of this medication have different||
5037|202|R|storage needs. Check the product package for instructions on how||
5037|203|R|to store your brand, or ask your pharmacist. Protect insulin from||
5037|204|R|light and heat. Do not store in the bathroom. Do not freeze, and||
5037|205|R|do not use insulin that has been frozen. Throw away all insulin||
5037|206|R|products after the expiration date on the package, or after the||
5037|207|R|specified number of days after it has been opened or kept at room||
5037|208|R|temperature, whichever date is earlier. Keep all medications away||
5037|209|R|from children and pets.||
5037|210|R|   Do not flush medications down the toilet or pour them into a||
5037|211|R|drain unless instructed to do so. Properly discard this product||
5037|212|R|when it is expired or no longer needed. Consult your pharmacist||
5037|213|R|or local waste disposal company.||
5037|214|B|||
5037|215|M|MEDICAL ALERT:  Your condition can cause complications in a||
5037|216|M|medical emergency. For information about enrolling in MedicAlert,||
5037|217|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5037|218|B|||
5037|219|A|Information last revised May 2025.||
5037|220|A|Copyright(c) 2025 First Databank, Inc.||
5037|221|B|||
5038|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5038|002|Z|does NOT have all possible information about this product. This||
5038|003|Z|information does not assure that this product is safe, effective,||
5038|004|Z|or appropriate for you. This information is not individual||
5038|005|Z|medical advice and does not substitute for the advice of your||
5038|006|Z|health care professional. Always ask your health care||
5038|007|Z|professional for complete information about this product and your||
5038|008|Z|specific health needs.||
5038|009|B|||
5038|010|T|SODIUM FLUORIDE - ORAL||
5038|011|F|(SO-dee-um FLOOR-ide)||
5038|012|B|||
5038|013|C|COMMON BRAND NAME(S): Fluor-A-Day, Karidium, Luride||
5038|014|B|||
5038|015|U|USES:  This medication is used to prevent cavities. It makes||
5038|016|U|teeth stronger and more resistant to decay caused by acid and||
5038|017|U|bacteria. Talk to your dentist or doctor about the benefits and||
5038|018|U|risks of this product.||
5038|019|U|   This medication is not recommended for use in children younger||
5038|020|U|than 3 years old.||
5038|021|U|   This medication is not recommended for use in areas where the||
5038|022|U|fluoride content in the water supply is greater than 0.6 parts||
5038|023|U|per million. See Notes section for more information.||
5038|024|B|||
5038|025|H|HOW TO USE:  Take this medication by mouth as directed by your||
5038|026|H|doctor/dentist, usually once daily.||
5038|027|H|   The dosage is based on your age and the fluoride content in||
5038|028|H|your water supply.||
5038|029|H|   If you are using the liquid form of this medication, measure||
5038|030|H|the dose carefully using the specially marked medicine dropper||
5038|031|H|that is provided. Drops may be swallowed directly, added to a||
5038|032|H|small amount of juice, or mixed with a small amount of food such||
5038|033|H|as applesauce. Do not mix with food containing milk or other||
5038|034|H|dairy products.||
5038|035|H|   If you are using the chewable form of this medication, chew or||
5038|036|H|dissolve it in the mouth before swallowing so that the teeth will||
5038|037|H|also absorb the fluoride. Take the chewable form at bedtime after||
5038|038|H|brushing your teeth or as directed by your doctor/dentist. For||
5038|039|H|best results, do not rinse your mouth, eat, or drink for 30||
5038|040|H|minutes after taking this medication.||
5038|041|H|   Take this medication 1 hour apart from products that contain||
5038|042|H|calcium, aluminum, or magnesium. Some examples include dairy||
5038|043|H|products (such as milk, yogurt), antacids, laxatives, and||
5038|044|H|vitamins/minerals. These products can bind with fluoride,||
5038|045|H|preventing its full absorption.||
5038|046|H|   Use this medication regularly in order to get the most benefit||
5038|047|H|from it. To help you remember, take it at the same time each day.||
5038|048|B|||
5038|049|S|SIDE EFFECTS:  Stomach upset may occur. If this effect lasts or||
5038|050|S|gets worse, tell your doctor/dentist or pharmacist promptly.||
5038|051|S|   Tell your doctor/dentist right away if your teeth become||
5038|052|S|stained or pitted. This is often a result of too much fluoride.||
5038|053|S|   Remember that this medication has been prescribed because your||
5038|054|S|doctor or dentist has judged that the benefit to you is greater||
5038|055|S|than the risk of side effects. Many people using this medication||
5038|056|S|do not have serious side effects.||
5038|057|S|   A very serious allergic reaction to this drug is rare.||
5038|058|S|However, get medical help right away if you notice any symptoms||
5038|059|S|of a serious allergic reaction, including: rash, itching/swelling||
5038|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5038|061|S|breathing.||
5038|062|S|   This is not a complete list of possible side effects. If you||
5038|063|S|notice other effects not listed above, contact your||
5038|064|S|doctor/dentist or pharmacist.||
5038|065|S|   In the US -||
5038|066|S|   Call your doctor for medical advice about side effects. You||
5038|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5038|068|S|www.fda.gov/medwatch.||
5038|069|S|   In Canada - Call your doctor for medical advice about side||
5038|070|S|effects. You may report side effects to Health Canada at||
5038|071|S|1-866-234-2345.||
5038|072|B|||
5038|073|P|PRECAUTIONS:  Before taking this medication, tell your||
5038|074|P|doctor/dentist or pharmacist if you are allergic to it; or if you||
5038|075|P|have any other allergies. This product may contain inactive||
5038|076|P|ingredients, which can cause allergic reactions or other||
5038|077|P|problems. Talk to your pharmacist for more details.||
5038|078|P|   Before using this medication, tell your doctor/dentist or||
5038|079|P|pharmacist your medical history, especially of: mouth problems||
5038|080|P|(such as sores, mucositis).||
5038|081|P|   Before having surgery, tell your doctor or dentist about all||
5038|082|P|the products you use (including prescription drugs,||
5038|083|P|nonprescription drugs, and herbal products).||
5038|084|P|   Tell your doctor if you are pregnant before using this||
5038|085|P|medication.||
5038|086|P|   This medication passes into breast milk. Consult your doctor||
5038|087|P|before breastfeeding.||
5038|088|B|||
5038|089|I|DRUG INTERACTIONS:  See also How to Use section.||
5038|090|I|   Drug interactions may change how your medications work or||
5038|091|I|increase your risk for serious side effects. This document does||
5038|092|I|not contain all possible drug interactions. Keep a list of all||
5038|093|I|the products you use (including prescription/nonprescription||
5038|094|I|drugs and herbal products) and share it with your doctor and||
5038|095|I|pharmacist. Do not start, stop, or change the dosage of any||
5038|096|I|medicines without your doctor's approval.||
5038|097|B|||
5038|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5038|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5038|100|O|poison control center right away. US residents can call||
5038|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5038|102|O|Symptoms of overdose may include: burning in the mouth, sore||
5038|103|O|tongue, nausea, vomiting, diarrhea, increased saliva, stomach||
5038|104|O|pain/cramping, muscle weakness, shaking, seizures.||
5038|105|B|||
5038|106|N|NOTES:  Do not share this medication with others.||
5038|107|N|   Taking this medication does not replace good dental habits.||
5038|108|N|Continue to brush and floss your teeth regularly as directed by||
5038|109|N|your dentist, and have regular dental checkups.||
5038|110|N|   Check the fluoride content of your water supply by asking your||
5038|111|N|local water provider. Fluoride supplements are not necessary if||
5038|112|N|the fluoride content in the water supply is greater than 0.6||
5038|113|N|parts per million. If your water supply changes or if you move,||
5038|114|N|check with your doctor or dentist to determine if extra fluoride||
5038|115|N|is still necessary.||
5038|116|B|||
5038|117|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5038|118|D|remember. If it is near the time of the next dose, skip the||
5038|119|D|missed dose. Take your next dose at the regular time. Do not||
5038|120|D|double the dose to catch up.||
5038|121|B|||
5038|122|R|STORAGE:  Store at room temperature away from heat and moisture.||
5038|123|R|Store the liquid form in the original plastic container. Do not||
5038|124|R|store in the bathroom. Keep all medications away from children||
5038|125|R|and pets.||
5038|126|R|   Do not flush medications down the toilet or pour them into a||
5038|127|R|drain unless instructed to do so. Properly discard this product||
5038|128|R|when it is expired or no longer needed. Consult your pharmacist||
5038|129|R|or local waste disposal company.||
5038|130|B|||
5038|131|A|Information last revised November 2025.||
5038|132|A|Copyright(c) 2025 First Databank, Inc.||
5038|133|B|||
5039|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5039|002|Z|does NOT have all possible information about this product. This||
5039|003|Z|information does not assure that this product is safe, effective,||
5039|004|Z|or appropriate for you. This information is not individual||
5039|005|Z|medical advice and does not substitute for the advice of your||
5039|006|Z|health care professional. Always ask your health care||
5039|007|Z|professional for complete information about this product and your||
5039|008|Z|specific health needs.||
5039|009|B|||
5039|010|T|TRETINOIN CREAM - TOPICAL||
5039|011|F|(tret-ih-NO-in)||
5039|012|B|||
5039|013|C|COMMON BRAND NAME(S): Renova||
5039|014|B|||
5039|015|U|USES:  This medication is used to improve the appearance of the||
5039|016|U|skin by reducing fine lines and wrinkles, reducing roughness, and||
5039|017|U|improving skin color. It should be used with a skin care and||
5039|018|U|sunlight-avoidance program that includes moisturizer and daily||
5039|019|U|use of an effective sunscreen (minimum SPF 15).||
5039|020|U|   Tretinoin belongs to a class of medications called retinoids.||
5039|021|U|It works by affecting the growth of skin cells. Tretinoin does||
5039|022|U|not repair sun-damaged skin or reverse aging due to sun exposure.||
5039|023|B|||
5039|024|V|OTHER USES:  This section contains uses of this drug that are not||
5039|025|V|listed in the approved professional labeling for the drug but||
5039|026|V|that may be prescribed by your health care professional. Use this||
5039|027|V|drug for a condition that is listed in this section only if it||
5039|028|V|has been so prescribed by your health care professional.||
5039|029|V|   This drug may also be used for other skin conditions,||
5039|030|V|including acne.||
5039|031|B|||
5039|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5039|033|H|from your pharmacist before you start using this medication and||
5039|034|H|each time you get a refill. If you have any questions, ask your||
5039|035|H|doctor or pharmacist||
5039|036|H|   Gently clean your face with a mild or soapless cleanser and||
5039|037|H|pat skin dry. Wait 20 to 30 minutes before applying this||
5039|038|H|medication. Apply a pea-sized amount of cream, using just enough||
5039|039|H|to cover your entire face lightly as directed by your doctor,||
5039|040|H|usually once a day before bedtime. Be careful to avoid your eyes,||
5039|041|H|nostrils and mouth. Do not wash your face or apply another skin||
5039|042|H|care product for at least 1 hour after using this product.||
5039|043|H|   Do not use more of this medication than prescribed or use it||
5039|044|H|more often. It will not give you faster or better results, but||
5039|045|H|will increase the risk of developing redness, peeling and pain.||
5039|046|H|Do not use on cut, scraped, sunburned, or eczema-affected skin.||
5039|047|H|   Avoid getting this medication in your eyes. If this medication||
5039|048|H|gets into your eyes, flush with large amounts of water. Call your||
5039|049|H|doctor if eye irritation develops. Wash your hands after using||
5039|050|H|the medication to avoid accidentally getting it in your eyes.||
5039|051|H|   Effects of this medication will appear slowly, with most||
5039|052|H|improvement seen in the first 6 months of use.||
5039|053|H|   If used for acne, your condition may get worse at first and||
5039|054|H|then get better.||
5039|055|B|||
5039|056|S|SIDE EFFECTS:  Warmth or stinging may occur right after applying||
5039|057|S|the medication. Skin redness, dryness, itching, scaling, mild||
5039|058|S|burning, or worsening of acne may occur during the first 2 to 4||
5039|059|S|weeks of using the medication. These effects usually decrease||
5039|060|S|with continued use. A daytime moisturizer may be helpful for very||
5039|061|S|dry skin (see Notes). If any of these effects last or get worse,||
5039|062|S|tell your doctor or pharmacist promptly.||
5039|063|S|   Remember that this medication has been prescribed because your||
5039|064|S|doctor has judged that the benefit to you is greater than the||
5039|065|S|risk of side effects. Many people using this medication do not||
5039|066|S|have serious side effects.||
5039|067|S|   Tell your doctor right away if you have any serious side||
5039|068|S|effects, including: blistering/crusting of the skin, severe||
5039|069|S|burning/swelling of the skin, darkening or lightening of skin||
5039|070|S|color.||
5039|071|S|   A very serious allergic reaction to this drug is rare.||
5039|072|S|However, get medical help right away if you notice any symptoms||
5039|073|S|of a serious allergic reaction, including: rash, itching/swelling||
5039|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5039|075|S|breathing.||
5039|076|S|   This is not a complete list of possible side effects. If you||
5039|077|S|notice other effects not listed above, contact your doctor or||
5039|078|S|pharmacist.||
5039|079|S|   In the US -||
5039|080|S|   Call your doctor for medical advice about side effects. You||
5039|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5039|082|S|www.fda.gov/medwatch.||
5039|083|S|   In Canada - Call your doctor for medical advice about side||
5039|084|S|effects. You may report side effects to Health Canada at||
5039|085|S|1-866-234-2345.||
5039|086|B|||
5039|087|P|PRECAUTIONS:  Before using tretinoin, tell your doctor or||
5039|088|P|pharmacist if you are allergic to it; or to vitamin A-related||
5039|089|P|drugs (other retinoids such as isotretinoin); or if you have any||
5039|090|P|other allergies. This product may contain inactive ingredients,||
5039|091|P|which can cause allergic reactions or other problems. Talk to||
5039|092|P|your pharmacist for more details.||
5039|093|P|   Before using this medication, tell your doctor or pharmacist||
5039|094|P|your medical history, especially of: eczema.||
5039|095|P|   This medication may make you more sensitive to the sun. Limit||
5039|096|P|your time in the sun. Avoid tanning booths and sunlamps. Weather||
5039|097|P|extremes such as wind or cold may also be irritating to the skin.||
5039|098|P|Use sunscreen daily and wear protective clothing when outdoors.||
5039|099|P|Tell your doctor right away if you get sunburned or have skin||
5039|100|P|blisters/redness. Wait until your skin has completely recovered||
5039|101|P|from a sunburn before using tretinoin.||
5039|102|P|   Avoid electrolysis, waxing and chemical depilatories for hair||
5039|103|P|removal on the treated areas while using this product.||
5039|104|P|   Before having surgery, tell your doctor or dentist about all||
5039|105|P|the products you use (including prescription drugs,||
5039|106|P|nonprescription drugs, and herbal products).||
5039|107|P|   During pregnancy, this medication should be used only when||
5039|108|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
5039|109|P|benefits with your doctor.||
5039|110|P|   It is unknown if this drug passes into breast milk. Consult||
5039|111|P|your doctor before breastfeeding.||
5039|112|B|||
5039|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5039|114|I|medications work or increase your risk for serious side effects.||
5039|115|I|This document does not contain all possible drug interactions.||
5039|116|I|Keep a list of all the products you use (including||
5039|117|I|prescription/nonprescription drugs and herbal products) and share||
5039|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
5039|119|I|the dosage of any medicines without your doctor's approval.||
5039|120|I|   Avoid using other skin products that are harsh, irritating, or||
5039|121|I|drying on the treated area. These products include hair perming||
5039|122|I|solutions, alcohol/lime/menthol-containing products (such as||
5039|123|I|astringents, toners, shaving lotion), medicated or abrasive soaps||
5039|124|I|or cleansers, soaps and cosmetics with a strong drying effect||
5039|125|I|(such as alpha hydroxy acids, glycolic acid), and products||
5039|126|I|containing sulfur, resorcinol, or salicylic acid.||
5039|127|I|   Benzoyl peroxide should not be applied at the same time as||
5039|128|I|this medication.||
5039|129|B|||
5039|130|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5039|131|O|has overdosed and has serious symptoms such as passing out or||
5039|132|O|trouble breathing, call 911. Otherwise, call a poison control||
5039|133|O|center right away. US residents can call 1-800-222-1222. Canada||
5039|134|O|residents can call 1-844-764-7669.||
5039|135|B|||
5039|136|N|NOTES:  Cosmetics may be used 1 hour after applying tretinoin. Be||
5039|137|N|sure to clean skin well before applying the medication. Daily||
5039|138|N|moisturizer should be used to protect your skin from dryness.||
5039|139|N|   Do not share this medication with others.||
5039|140|B|||
5039|141|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5039|142|D|If it is near the time of the next dose, skip the missed dose.||
5039|143|D|Use your next dose at the regular time. Do not double the dose to||
5039|144|D|catch up.||
5039|145|B|||
5039|146|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
5039|147|R|medications away from children and pets.||
5039|148|R|   Do not flush medications down the toilet or pour them into a||
5039|149|R|drain unless instructed to do so. Properly discard this product||
5039|150|R|when it is expired or no longer needed. Consult your pharmacist||
5039|151|R|or local waste disposal company.||
5039|152|B|||
5039|153|A|Information last revised November 2024.||
5039|154|A|Copyright(c) 2025 First Databank, Inc.||
5039|155|B|||
5041|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5041|002|Z|does NOT have all possible information about this product. This||
5041|003|Z|information does not assure that this product is safe, effective,||
5041|004|Z|or appropriate for you. This information is not individual||
5041|005|Z|medical advice and does not substitute for the advice of your||
5041|006|Z|health care professional. Always ask your health care||
5041|007|Z|professional for complete information about this product and your||
5041|008|Z|specific health needs.||
5041|009|B|||
5041|010|T|CARBIDOPA/LEVODOPA SUSTAINED-RELEASE TABLET - ORAL||
5041|011|F|(KAR-bi-DOE-pa/LEE-voe-DOE-pa)||
5041|012|B|||
5041|013|C|COMMON BRAND NAME(S): Sinemet CR||
5041|014|B|||
5041|015|U|USES:  This combination medication is used to treat symptoms of||
5041|016|U|Parkinson's disease or Parkinson-like symptoms (such as||
5041|017|U|shakiness, stiffness, difficulty moving). Parkinson's disease is||
5041|018|U|thought to be caused by too little of a naturally occurring||
5041|019|U|substance (dopamine) in the brain. Levodopa changes into dopamine||
5041|020|U|in the brain, helping to control movement. Carbidopa prevents the||
5041|021|U|breakdown of levodopa in the bloodstream so more levodopa can||
5041|022|U|enter the brain. Carbidopa can also reduce some of levodopa's||
5041|023|U|side effects such as nausea and vomiting.||
5041|024|B|||
5041|025|H|HOW TO USE:  Take this medication by mouth with or without food||
5041|026|H|as directed by your doctor, usually 2 to 3 times a day. Doses are||
5041|027|H|usually taken 4 to 8 hours apart while awake.||
5041|028|H|   Do not crush or chew this medication. Doing so can release all||
5041|029|H|of the drug at once, increasing the risk of side effects. Also,||
5041|030|H|do not split the tablets unless they have a score line and your||
5041|031|H|doctor or pharmacist tells you to do so. Swallow the whole or||
5041|032|H|split tablet without crushing or chewing.||
5041|033|H|   Taking this medication with food may help to decrease nausea.||
5041|034|H|It is best to avoid a high-protein diet (it decreases the amount||
5041|035|H|of levodopa that your body takes in) during treatment, unless||
5041|036|H|directed otherwise by your doctor. Separate your dose of this||
5041|037|H|medication by as many hours as possible from any iron supplements||
5041|038|H|or products containing iron (such as multivitamins with minerals)||
5041|039|H|you may take. Iron can reduce the amount of this medication||
5041|040|H|absorbed by the body. Consult your doctor or pharmacist for more||
5041|041|H|details.||
5041|042|H|   The dosage is based on your medical condition and response to||
5041|043|H|treatment. If you are switching from immediate-release||
5041|044|H|levodopa/carbidopa to this product, your doctor may slightly||
5041|045|H|increase your dose of this medication to get the same response.||
5041|046|H|This medication may take a little longer to work in the morning||
5041|047|H|than the immediate-release medication because it is absorbed more||
5041|048|H|slowly. Let your doctor know if this becomes a problem.||
5041|049|H|   Use this medication regularly to get the most benefit from it.||
5041|050|H|To help you remember, take it at the same times each day.||
5041|051|H|   Your doctor may also prescribe immediate-release||
5041|052|H|carbidopa/levodopa or carbidopa alone to be taken with this||
5041|053|H|medication. Make sure you understand your dosing schedule and||
5041|054|H|follow it closely.||
5041|055|H|   Some patients may experience a "wearing-off" (worsening of||
5041|056|H|symptoms) before the next dose is due. An "on-off" effect might||
5041|057|H|also occur, in which sudden short periods of stiffness occur. If||
5041|058|H|these effects occur, contact your doctor for possible dose||
5041|059|H|adjustments that may help to lessen this effect.||
5041|060|H|   Do not stop taking this medication without consulting your||
5041|061|H|doctor. Some conditions may become worse when this medication is||
5041|062|H|suddenly stopped. Also, if you suddenly stop using this||
5041|063|H|medication, you may have withdrawal symptoms (such as anxiety,||
5041|064|H|depression, confusion, fever, muscle stiffness). To help prevent||
5041|065|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
5041|066|H|more likely if you have used this medication for a long time or||
5041|067|H|in high doses. Tell your doctor or pharmacist right away if you||
5041|068|H|have withdrawal.||
5041|069|H|   Tell your doctor if your condition does not get better or if||
5041|070|H|it gets worse.||
5041|071|B|||
5041|072|S|SIDE EFFECTS:  Dizziness, lightheadedness, nausea, vomiting, loss||
5041|073|S|of appetite, trouble sleeping, unusual dreams, or headache may||
5041|074|S|occur. If any of these effects last or get worse, tell your||
5041|075|S|doctor or pharmacist promptly.||
5041|076|S|   This medication may cause saliva, urine, or sweat to turn a||
5041|077|S|dark color. This effect is harmless, but your clothes may be||
5041|078|S|stained.||
5041|079|S|   To reduce the risk of dizziness and lightheadedness, get up||
5041|080|S|slowly when rising from a sitting or lying position.||
5041|081|S|   Remember that this medication has been prescribed because your||
5041|082|S|doctor has judged that the benefit to you is greater than the||
5041|083|S|risk of side effects. Many people using this medication do not||
5041|084|S|have serious side effects.||
5041|085|S|   Some people taking this medication have fallen asleep suddenly||
5041|086|S|during their usual daily activities (such as talking on the||
5041|087|S|phone, driving). In some cases, sleep occurred without any||
5041|088|S|feelings of drowsiness beforehand. This sleep effect may occur||
5041|089|S|anytime during treatment with this medication even if you have||
5041|090|S|used this medication for a long time. If you experience increased||
5041|091|S|sleepiness or fall asleep during the day, do not drive or do||
5041|092|S|other possibly dangerous activities until you have discussed this||
5041|093|S|effect with your doctor. Your risk of this sleep effect is||
5041|094|S|increased by using alcohol or other medications that can make you||
5041|095|S|drowsy. See also Precautions section.||
5041|096|S|   Tell your doctor right away if you have any serious side||
5041|097|S|effects, including: new/worsening movements you can't||
5041|098|S|control/spasms, greatly increased eye blinking/twitching, vision||
5041|099|S|changes (such as blurred vision, double vision), eye pain, severe||
5041|100|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
5041|101|S|coffee grounds, mental/mood changes (such as confusion,||
5041|102|S|agitation, hallucinations), signs of infection (such as sore||
5041|103|S|throat that doesn't go away, fever, chills), easy||
5041|104|S|bleeding/bruising, unusual tiredness, tingling of the hands/feet,||
5041|105|S|unusual strong urges (such as increased gambling, increased||
5041|106|S|sexual urges).||
5041|107|S|   Get medical help right away if you have any very serious side||
5041|108|S|effects, including: chest pain, fainting.||
5041|109|S|   Abruptly stopping or reducing the dose of this medication may||
5041|110|S|rarely cause a very serious condition called neuroleptic||
5041|111|S|malignant syndrome (NMS). Get medical help right away if you have||
5041|112|S|any of the following symptoms: fever, unusual muscle stiffness,||
5041|113|S|severe confusion, sweating, fast/irregular heartbeat.||
5041|114|S|   A very serious allergic reaction to this drug is rare.||
5041|115|S|However, get medical help right away if you notice any symptoms||
5041|116|S|of a serious allergic reaction, including: rash, itching/swelling||
5041|117|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5041|118|S|breathing.||
5041|119|S|   This is not a complete list of possible side effects. If you||
5041|120|S|notice other effects not listed above, contact your doctor or||
5041|121|S|pharmacist.||
5041|122|S|   In the US -||
5041|123|S|   Call your doctor for medical advice about side effects. You||
5041|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5041|125|S|www.fda.gov/medwatch.||
5041|126|S|   In Canada - Call your doctor for medical advice about side||
5041|127|S|effects. You may report side effects to Health Canada at||
5041|128|S|1-866-234-2345.||
5041|129|B|||
5041|130|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
5041|131|P|pharmacist if you are allergic to carbidopa or levodopa; or to||
5041|132|P|foscarbidopa or foslevodopa; or if you have any other allergies.||
5041|133|P|This product may contain inactive ingredients, which can cause||
5041|134|P|allergic reactions or other problems. Talk to your pharmacist for||
5041|135|P|more details.||
5041|136|P|   Before using this medication, tell your doctor or pharmacist||
5041|137|P|your medical history, especially of: liver disease, glaucoma,||
5041|138|P|breathing problems (such as asthma), heart disease (such as heart||
5041|139|P|attack, irregular heartbeat), kidney disease, stomach/intestinal||
5041|140|P|ulcer, mental/mood disorders (such as depression, schizophrenia),||
5041|141|P|blood disorders, seizures, sleep disorders.||
5041|142|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5041|143|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5041|144|P|machinery, or do anything that needs alertness until you can do||
5041|145|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5041|146|P|are using marijuana (cannabis). See also Side Effects section.||
5041|147|P|   Before having surgery, tell your doctor or dentist about all||
5041|148|P|the products you use (including prescription drugs,||
5041|149|P|nonprescription drugs, and herbal products).||
5041|150|P|   During pregnancy, this medication should be used only when||
5041|151|P|clearly needed. Discuss the risks and benefits with your doctor.||
5041|152|P|   Levodopa passes into breast milk. It is unknown if carbidopa||
5041|153|P|passes into breast milk. Consult your doctor before||
5041|154|P|breastfeeding.||
5041|155|B|||
5041|156|I|DRUG INTERACTIONS:  See also How to Use section.||
5041|157|I|   Drug interactions may change how your medications work or||
5041|158|I|increase your risk for serious side effects. This document does||
5041|159|I|not contain all possible drug interactions. Keep a list of all||
5041|160|I|the products you use (including prescription/nonprescription||
5041|161|I|drugs and herbal products) and share it with your doctor and||
5041|162|I|pharmacist. Do not start, stop, or change the dosage of any||
5041|163|I|medicines without your doctor's approval.||
5041|164|I|   Taking MAO inhibitors with this medication may cause a serious||
5041|165|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
5041|166|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
5041|167|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
5041|168|I|treatment with this medication. Most MAO inhibitors should also||
5041|169|I|not be taken for two weeks before treatment with this medication.||
5041|170|I|However, certain MAO inhibitors (rasagiline, safinamide,||
5041|171|I|selegiline) may be used with careful monitoring by your doctor.||
5041|172|I|Ask your doctor when to start or stop taking this medication.||
5041|173|I|   This medication may interfere with certain lab tests (such as||
5041|174|I|urine catecholamine/glucose/ketone tests), possibly causing false||
5041|175|I|test results. Make sure lab personnel and all your doctors know||
5041|176|I|you use this drug.||
5041|177|B|||
5041|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5041|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5041|180|O|poison control center right away. US residents can call||
5041|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5041|182|O|Symptoms of overdose may include: severe dizziness, irregular||
5041|183|O|heartbeat, mental/mood changes (such as agitation).||
5041|184|B|||
5041|185|N|NOTES:  Do not share this medication with others.||
5041|186|N|   Lab and/or medical tests (such as complete blood count,||
5041|187|N|heart/kidney/liver function, blood pressure) should be done while||
5041|188|N|you are taking this medication. Keep all medical and lab||
5041|189|N|appointments. Consult your doctor for more details.||
5041|190|B|||
5041|191|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5041|192|D|remember. If it is near the time of the next dose, skip the||
5041|193|D|missed dose. Take your next dose at the regular time. Do not||
5041|194|D|double the dose to catch up.||
5041|195|B|||
5041|196|R|STORAGE:  Store at room temperature away from light and moisture.||
5041|197|R|Do not store in the bathroom. Keep all medications away from||
5041|198|R|children and pets.||
5041|199|R|   Do not flush medications down the toilet or pour them into a||
5041|200|R|drain unless instructed to do so. Properly discard this product||
5041|201|R|when it is expired or no longer needed. Consult your pharmacist||
5041|202|R|or local waste disposal company.||
5041|203|B|||
5041|204|A|Information last revised May 2025.||
5041|205|A|Copyright(c) 2025 First Databank, Inc.||
5041|206|B|||
5046|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5046|002|Z|does NOT have all possible information about this product. This||
5046|003|Z|information does not assure that this product is safe, effective,||
5046|004|Z|or appropriate for you. This information is not individual||
5046|005|Z|medical advice and does not substitute for the advice of your||
5046|006|Z|health care professional. Always ask your health care||
5046|007|Z|professional for complete information about this product and your||
5046|008|Z|specific health needs.||
5046|009|B|||
5046|010|T|FLUOROURACIL - TOPICAL||
5046|011|F|(flewr-oh-YOUR-uh-sill)||
5046|012|B|||
5046|013|C|COMMON BRAND NAME(S): Efudex, Fluoroplex||
5046|014|B|||
5046|015|U|USES:  This medication is used on the skin to treat pre-cancerous||
5046|016|U|and cancerous skin growths. Fluorouracil belongs to a class of||
5046|017|U|medications known as anti-metabolites. It works by blocking the||
5046|018|U|growth of abnormal cells that cause the skin condition.||
5046|019|B|||
5046|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5046|021|H|from your pharmacist before you start using this medication and||
5046|022|H|each time you get a refill. If you have any questions, ask your||
5046|023|H|doctor or pharmacist.||
5046|024|H|   Use this medication as directed by your doctor. Before you||
5046|025|H|apply this medication to the skin, clean the affected area and||
5046|026|H|dry well. Wait 10 minutes, then apply a small amount of||
5046|027|H|medication to the affected skin, using just enough to cover the||
5046|028|H|area with a thin film. Wash your hands immediately after applying||
5046|029|H|this medication, even if you have used gloves.||
5046|030|H|   The treated area may become unsightly during treatment and in||
5046|031|H|some cases for several weeks after treatment. Do not cover the||
5046|032|H|area with tight dressings or plastic bandages. Check with your||
5046|033|H|doctor whether you may cover the treated area loosely with gauze.||
5046|034|H|   Avoid applying this medication in or around the eyes or||
5046|035|H|eyelids. Also, do not apply this medication inside the nose or||
5046|036|H|mouth. If you do get the medication in these areas, rinse with||
5046|037|H|plenty of water.||
5046|038|H|   This medication may cause serious harm (even death) in pets.||
5046|039|H|Keep this medication securely away from pets, and do not allow||
5046|040|H|pets to lick the area where the medication was applied. Contact||
5046|041|H|your vet right away if your pet comes into contact with this||
5046|042|H|medication.||
5046|043|H|   Use this medication exactly as prescribed. Do not stop using||
5046|044|H|this medication without consulting your doctor. Do not increase||
5046|045|H|your dose or use it more often than directed. Your condition will||
5046|046|H|not clear faster, but side effects will be increased.||
5046|047|H|   Tell your doctor if your condition gets worse or if it does||
5046|048|H|not get better.||
5046|049|B|||
5046|050|S|SIDE EFFECTS:  Skin irritation, burning, redness, dryness, pain,||
5046|051|S|swelling, tenderness, or changes in skin color may occur at the||
5046|052|S|site of application. Eye irritation (such as stinging, watering),||
5046|053|S|trouble sleeping, irritability, temporary hair loss, or abnormal||
5046|054|S|taste in the mouth may also occur. If any of these effects last||
5046|055|S|or get worse, tell your doctor or pharmacist promptly.||
5046|056|S|   Remember that this medication has been prescribed because your||
5046|057|S|doctor has judged that the benefit to you is greater than the||
5046|058|S|risk of side effects. Many people using this medication do not||
5046|059|S|have serious side effects.||
5046|060|S|   Tell your doctor right away if you have any serious side||
5046|061|S|effects, including: stomach/abdominal pain, bloody diarrhea,||
5046|062|S|vomiting, signs of infection (such as sore throat that doesn't go||
5046|063|S|away, fever, chills), easy bruising/bleeding, mouth sores.||
5046|064|S|   A very serious allergic reaction to this drug is rare.||
5046|065|S|However, get medical help right away if you notice any symptoms||
5046|066|S|of a serious allergic reaction, including: rash, itching/swelling||
5046|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5046|068|S|breathing.||
5046|069|S|   This is not a complete list of possible side effects. If you||
5046|070|S|notice other effects not listed above, contact your doctor or||
5046|071|S|pharmacist.||
5046|072|S|   In the US -||
5046|073|S|   Call your doctor for medical advice about side effects. You||
5046|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5046|075|S|www.fda.gov/medwatch.||
5046|076|S|   In Canada - Call your doctor for medical advice about side||
5046|077|S|effects. You may report side effects to Health Canada at||
5046|078|S|1-866-234-2345.||
5046|079|B|||
5046|080|P|PRECAUTIONS:  Before using fluorouracil, tell your doctor or||
5046|081|P|pharmacist if you are allergic to it; or to flucytosine; or to||
5046|082|P|capecitabine; or if you have any other allergies. This product||
5046|083|P|may contain inactive ingredients (such as peanut oil found in||
5046|084|P|some brands), which can cause allergic reactions or other||
5046|085|P|problems. Talk to your pharmacist for more details.||
5046|086|P|   Before using this medication, tell your doctor or pharmacist||
5046|087|P|your medical history, especially of: a certain enzyme deficiency||
5046|088|P|(dihydropyrimidine dehydrogenase - DPD),||
5046|089|P|red/irritated/infected/open sores on skin.||
5046|090|P|   This medication may make you more sensitive to the sun. Limit||
5046|091|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5046|092|P|sunscreen and wear protective clothing when outdoors. After using||
5046|093|P|fluorouracil cream, wait 2 hours before applying sunscreen or||
5046|094|P|moisturizer to the treated area. Do not use other skin products||
5046|095|P|including creams, lotions, medications, or cosmetics unless||
5046|096|P|instructed by your doctor to do so. Tell your doctor right away||
5046|097|P|if you get sunburned or have skin blisters/redness.||
5046|098|P|   Before having surgery, tell your doctor or dentist about all||
5046|099|P|the products you use (including prescription drugs,||
5046|100|P|nonprescription drugs, and herbal products).||
5046|101|P|   This medication must not be used during pregnancy. It may harm||
5046|102|P|an unborn baby. Discuss the use of reliable forms of birth||
5046|103|P|control with your doctor. If you become pregnant or think you may||
5046|104|P|be pregnant, tell your doctor right away.||
5046|105|P|   It is unknown if this medication passes into breast milk.||
5046|106|P|Because of the possible risk to the infant, breastfeeding is not||
5046|107|P|recommended while using this medication. Consult your doctor||
5046|108|P|before breastfeeding.||
5046|109|B|||
5046|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5046|111|I|medications work or increase your risk for serious side effects.||
5046|112|I|This document does not contain all possible drug interactions.||
5046|113|I|Keep a list of all the products you use (including||
5046|114|I|prescription/nonprescription drugs and herbal products) and share||
5046|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
5046|116|I|the dosage of any medicines without your doctor's approval.||
5046|117|B|||
5046|118|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5046|119|O|has overdosed and has serious symptoms such as passing out or||
5046|120|O|trouble breathing, call 911. Otherwise, call a poison control||
5046|121|O|center right away. US residents can call 1-800-222-1222. Canada||
5046|122|O|residents can call 1-844-764-7669.||
5046|123|B|||
5046|124|N|NOTES:  Do not share this medication with others.||
5046|125|N|   This medication must be used under close medical supervision.||
5046|126|N|Be sure to keep all your medical appointments so your doctor can||
5046|127|N|monitor your progress or any side effects.||
5046|128|N|   Discard any unused medication when the treatment is finished.||
5046|129|N|Do not use it for any other skin conditions unless directed to do||
5046|130|N|so by your doctor.||
5046|131|N|   There are different brands and forms of this medication||
5046|132|N|available. Not all have identical effects. Do not change brands||
5046|133|N|or forms without consulting your doctor or pharmacist.||
5046|134|B|||
5046|135|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5046|136|D|If it is near the time of the next dose, skip the missed dose.||
5046|137|D|Use your next dose at the regular time. Do not double the dose to||
5046|138|D|catch up.||
5046|139|B|||
5046|140|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
5046|141|R|medications away from children and pets.||
5046|142|R|   Do not flush medications down the toilet or pour them into a||
5046|143|R|drain unless instructed to do so. Properly discard this product||
5046|144|R|when it is expired or no longer needed. Consult your pharmacist||
5046|145|R|or local waste disposal company.||
5046|146|B|||
5046|147|A|Information last revised November 2024.||
5046|148|A|Copyright(c) 2025 First Databank, Inc.||
5046|149|B|||
5047|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5047|002|Z|does NOT have all possible information about this product. This||
5047|003|Z|information does not assure that this product is safe, effective,||
5047|004|Z|or appropriate for you. This information is not individual||
5047|005|Z|medical advice and does not substitute for the advice of your||
5047|006|Z|health care professional. Always ask your health care||
5047|007|Z|professional for complete information about this product and your||
5047|008|Z|specific health needs.||
5047|009|B|||
5047|010|T|VENLAFAXINE - ORAL||
5047|011|F|(ven-luh-FAX-een)||
5047|012|B|||
5047|013|C|COMMON BRAND NAME(S): Effexor||
5047|014|B|||
5047|015|W|WARNING:  Antidepressant medications are used to treat a variety||
5047|016|W|of conditions, including depression and other mental/mood||
5047|017|W|disorders. These medications can help prevent suicidal||
5047|018|W|thoughts/attempts and provide other important benefits. However,||
5047|019|W|a small number of people (especially people younger than 25) who||
5047|020|W|take antidepressants for any condition may experience worsening||
5047|021|W|depression, other mental/mood symptoms, or suicidal||
5047|022|W|thoughts/attempts. It is very important to talk with the doctor||
5047|023|W|about the risks and benefits of antidepressant medication||
5047|024|W|(especially for people younger than 25), even if treatment is not||
5047|025|W|for a mental/mood condition.||
5047|026|W|   Tell the doctor right away if you notice worsening||
5047|027|W|depression/other psychiatric conditions, unusual behavior changes||
5047|028|W|(including possible suicidal thoughts/attempts), or other||
5047|029|W|mental/mood changes (including new/worsening anxiety, panic||
5047|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
5047|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
5047|032|W|especially watchful for these symptoms when a new antidepressant||
5047|033|W|is started or when the dose is changed.||
5047|034|B|||
5047|035|U|USES:  This medication is used to treat depression. Venlafaxine||
5047|036|U|belongs to a class of drugs known as serotonin-norepinephrine||
5047|037|U|reuptake inhibitors (SNRIs). It works by helping to restore the||
5047|038|U|balance of certain natural substances (serotonin and||
5047|039|U|norepinephrine) in the brain.||
5047|040|B|||
5047|041|V|OTHER USES:  This section contains uses of this drug that are not||
5047|042|V|listed in the approved professional labeling for the drug but||
5047|043|V|that may be prescribed by your health care professional. Use this||
5047|044|V|drug for a condition that is listed in this section only if it||
5047|045|V|has been so prescribed by your health care professional.||
5047|046|V|   This drug may also be used for anxiety, panic attacks, or||
5047|047|V|nerve pain. It may also be used for hot flashes that occur with||
5047|048|V|menopause.||
5047|049|B|||
5047|050|H|HOW TO USE:  Read the Medication Guide provided by your||
5047|051|H|pharmacist before you start using venlafaxine and each time you||
5047|052|H|get a refill. If you have any questions, ask your doctor or||
5047|053|H|pharmacist.||
5047|054|H|   Take this medication by mouth as directed by your doctor,||
5047|055|H|usually 2 to 3 times daily with food.||
5047|056|H|   The dosage is based on your medical condition and response to||
5047|057|H|treatment. To reduce your risk of side effects, your doctor may||
5047|058|H|direct you to start this medication at a low dose and gradually||
5047|059|H|increase your dose. Follow your doctor's instructions carefully.||
5047|060|H|Take this medication regularly to get the most benefit from it.||
5047|061|H|To help you remember, take it at the same times each day.||
5047|062|H|   Keep taking this medication even if you feel well. Do not stop||
5047|063|H|taking this medication without consulting your doctor. Some||
5047|064|H|conditions may become worse when this drug is suddenly stopped.||
5047|065|H|Also, you may experience symptoms such as confusion, mood swings,||
5047|066|H|blurred vision, headache, tiredness, sleep changes, and brief||
5047|067|H|feelings similar to electric shock. Your dose may need to be||
5047|068|H|gradually decreased to reduce side effects. Report any new or||
5047|069|H|worsening symptoms right away.||
5047|070|H|   It may take several weeks to feel the benefit of this||
5047|071|H|medication. Tell your doctor if your condition lasts or gets||
5047|072|H|worse.||
5047|073|B|||
5047|074|S|SIDE EFFECTS:  See also Warning section.||
5047|075|S|   Nausea, drowsiness, dizziness, dry mouth, constipation, loss||
5047|076|S|of appetite, blurred vision, nervousness, trouble sleeping,||
5047|077|S|unusual sweating, or yawning may occur. If any of these effects||
5047|078|S|last or get worse, tell your doctor promptly.||
5047|079|S|   Remember that this medication has been prescribed because your||
5047|080|S|doctor has judged that the benefit to you is greater than the||
5047|081|S|risk of side effects. Many people using this medication do not||
5047|082|S|have serious side effects.||
5047|083|S|   This medication may raise your blood pressure. Check your||
5047|084|S|blood pressure regularly and tell your doctor if the results are||
5047|085|S|high.||
5047|086|S|   Tell your doctor right away if you have any serious side||
5047|087|S|effects, including: easy bleeding/bruising, decreased interest in||
5047|088|S|sex, changes in sexual ability, muscle cramps/weakness, shaking||
5047|089|S|(tremor).||
5047|090|S|   Get medical help right away if you have any very serious side||
5047|091|S|effects, including: cough that doesn't go away, shortness of||
5047|092|S|breath, chest pain, severe/pounding headache, black stools, vomit||
5047|093|S|that looks like coffee grounds, eye pain/swelling/redness,||
5047|094|S|widened pupils, vision changes (such as seeing rainbows around||
5047|095|S|lights at night), seizure.||
5047|096|S|   This medication may increase serotonin and rarely cause a very||
5047|097|S|serious condition called serotonin syndrome/toxicity. The risk||
5047|098|S|increases if you are also taking other drugs that increase||
5047|099|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
5047|100|S|take (see Drug Interactions section). Get medical help right away||
5047|101|S|if you develop some of the following symptoms: fast heartbeat,||
5047|102|S|hallucinations, loss of coordination, severe dizziness, severe||
5047|103|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
5047|104|S|unusual agitation/restlessness.||
5047|105|S|   A very serious allergic reaction to this drug is rare.||
5047|106|S|However, get medical help right away if you notice any symptoms||
5047|107|S|of a serious allergic reaction, including: rash, itching/swelling||
5047|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5047|109|S|breathing.||
5047|110|S|   This is not a complete list of possible side effects. If you||
5047|111|S|notice other effects not listed above, contact your doctor or||
5047|112|S|pharmacist.||
5047|113|S|   In the US -||
5047|114|S|   Call your doctor for medical advice about side effects. You||
5047|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5047|116|S|www.fda.gov/medwatch.||
5047|117|S|   In Canada - Call your doctor for medical advice about side||
5047|118|S|effects. You may report side effects to Health Canada at||
5047|119|S|1-866-234-2345.||
5047|120|B|||
5047|121|P|PRECAUTIONS:  Before taking venlafaxine, tell your doctor or||
5047|122|P|pharmacist if you are allergic to it; or to desvenlafaxine; or if||
5047|123|P|you have any other allergies. This product may contain inactive||
5047|124|P|ingredients, which can cause allergic reactions or other||
5047|125|P|problems. Talk to your pharmacist for more details.||
5047|126|P|   Before using this medication, tell your doctor or pharmacist||
5047|127|P|your medical history, especially of: bleeding problems, personal||
5047|128|P|or family history of glaucoma (angle-closure type), high blood||
5047|129|P|pressure, heart problems (such as heart failure, previous heart||
5047|130|P|attack), high cholesterol, kidney disease, liver disease, seizure||
5047|131|P|disorder, thyroid disease.||
5047|132|P|   This drug may make you dizzy or drowsy or blur your vision.||
5047|133|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
5047|134|P|drowsy. Do not drive, use machinery, or do anything that needs||
5047|135|P|alertness or clear vision until you can do it safely. Avoid||
5047|136|P|alcoholic beverages. Talk to your doctor if you are using||
5047|137|P|marijuana (cannabis).||
5047|138|P|   Before having surgery, tell your doctor or dentist about all||
5047|139|P|the products you use (including prescription drugs,||
5047|140|P|nonprescription drugs, and herbal products).||
5047|141|P|   Older adults may be more sensitive to the side effects of this||
5047|142|P|drug, especially bleeding and dizziness when standing. Older||
5047|143|P|adults may also be more likely to develop a type of salt||
5047|144|P|imbalance (hyponatremia), especially if they are taking "water||
5047|145|P|pills" (diuretics). Dizziness and salt imbalance can increase the||
5047|146|P|risk of falling.||
5047|147|P|   Children may be more sensitive to the side effects of the||
5047|148|P|drug, especially loss of appetite and weight loss. Monitor weight||
5047|149|P|and height in children who are taking this drug.||
5047|150|P|   During pregnancy, this medication should be used only when||
5047|151|P|clearly needed. It may harm an unborn baby. Also, babies born to||
5047|152|P|mothers who have used this drug during the last 3 months of||
5047|153|P|pregnancy may rarely develop withdrawal symptoms such as||
5047|154|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
5047|155|P|constant crying. If you notice any of these symptoms in your||
5047|156|P|newborn, tell the doctor promptly.||
5047|157|P|   Since untreated mental/mood problems (such as depression,||
5047|158|P|anxiety, panic attacks) can be a serious condition, do not stop||
5047|159|P|taking this medication unless directed by your doctor. If you are||
5047|160|P|planning pregnancy, become pregnant, or think you may be||
5047|161|P|pregnant, immediately discuss the benefits and risks of using||
5047|162|P|this medication during pregnancy with your doctor.||
5047|163|P|   This drug passes into breast milk and may have undesirable||
5047|164|P|effects on a nursing infant. Consult your doctor before||
5047|165|P|breastfeeding.||
5047|166|B|||
5047|167|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5047|168|I|medications work or increase your risk for serious side effects.||
5047|169|I|This document does not contain all possible drug interactions.||
5047|170|I|Keep a list of all the products you use (including||
5047|171|I|prescription/nonprescription drugs and herbal products) and share||
5047|172|I|it with your doctor and pharmacist. Do not start, stop, or change||
5047|173|I|the dosage of any medicines without your doctor's approval.||
5047|174|I|   Some products that may interact with this drug are: other||
5047|175|I|drugs that can cause bleeding/bruising (including antiplatelet||
5047|176|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
5047|177|I|"blood thinners" such as dabigatran/warfarin).||
5047|178|I|   Aspirin can increase the risk of bleeding when used with this||
5047|179|I|medication. However, if your doctor has told you to take low-dose||
5047|180|I|aspirin to prevent heart attack or stroke (usually 81-162||
5047|181|I|milligrams a day), you should keep taking the aspirin unless your||
5047|182|I|doctor tells you not to. Ask your doctor or pharmacist for more||
5047|183|I|details.||
5047|184|I|   Taking MAO inhibitors with this medication may cause a serious||
5047|185|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
5047|186|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
5047|187|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
5047|188|I|selegiline, tranylcypromine) during treatment with this||
5047|189|I|medication. Most MAO inhibitors should also not be taken for two||
5047|190|I|weeks before and at least 7 days after treatment with this||
5047|191|I|medication. Ask your doctor when to start or stop taking this||
5047|192|I|medication.||
5047|193|I|   The risk of serotonin syndrome/toxicity increases if you are||
5047|194|I|also taking other drugs that increase serotonin. Examples include||
5047|195|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
5047|196|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
5047|197|I|other SNRIs such as duloxetine/milnacipran), tryptophan, among||
5047|198|I|others. The risk of serotonin syndrome/toxicity may be more||
5047|199|I|likely when you start or increase the dose of these drugs.||
5047|200|I|   Tell your doctor or pharmacist if you are taking other||
5047|201|I|products that cause drowsiness such as opioid pain or cough||
5047|202|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5047|203|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5047|204|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5047|205|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5047|206|I|diphenhydramine).||
5047|207|I|   Check the labels on all your medicines (such as allergy or||
5047|208|I|cough-and-cold products) because they may contain ingredients||
5047|209|I|that cause drowsiness. Ask your pharmacist about using those||
5047|210|I|products safely.||
5047|211|I|   Venlafaxine is very similar to desvenlafaxine. Do not take||
5047|212|I|medications containing desvenlafaxine while using venlafaxine.||
5047|213|I|   This medication may interfere with certain lab tests||
5047|214|I|(including urine tests for amphetamines), possibly causing false||
5047|215|I|test results. Make sure lab personnel and all your doctors know||
5047|216|I|you use this drug.||
5047|217|B|||
5047|218|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5047|219|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5047|220|O|poison control center right away. US residents can call||
5047|221|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5047|222|O|Symptoms of overdose may include: severe drowsiness, seizures,||
5047|223|O|fast/irregular heartbeat.||
5047|224|B|||
5047|225|N|NOTES:  Do not share this medication with others.||
5047|226|N|   Lab and/or medical tests (such as blood pressure, cholesterol)||
5047|227|N|should be done while you are taking this medication. Keep all||
5047|228|N|medical and lab appointments. Consult your doctor for more||
5047|229|N|details.||
5047|230|B|||
5047|231|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5047|232|D|remember. If it is near the time of the next dose, skip the||
5047|233|D|missed dose. Take your next dose at the regular time. Do not||
5047|234|D|double the dose to catch up.||
5047|235|B|||
5047|236|R|STORAGE:  Store at room temperature away from light and moisture.||
5047|237|R|Do not store in the bathroom. Keep all medications away from||
5047|238|R|children and pets.||
5047|239|R|   Do not flush medications down the toilet or pour them into a||
5047|240|R|drain unless instructed to do so. Properly discard this product||
5047|241|R|when it is expired or no longer needed. Consult your pharmacist||
5047|242|R|or local waste disposal company.||
5047|243|B|||
5047|244|A|Information last revised May 2024.||
5047|245|A|Copyright(c) 2025 First Databank, Inc.||
5047|246|B|||
5048|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5048|002|Z|does NOT have all possible information about this product. This||
5048|003|Z|information does not assure that this product is safe, effective,||
5048|004|Z|or appropriate for you. This information is not individual||
5048|005|Z|medical advice and does not substitute for the advice of your||
5048|006|Z|health care professional. Always ask your health care||
5048|007|Z|professional for complete information about this product and your||
5048|008|Z|specific health needs.||
5048|009|B|||
5048|010|T|ISOSORBIDE MONONITRATE - ORAL||
5048|011|F|(EYE-soe-SOR-bide MON-oh-NYE-trate)||
5048|012|B|||
5048|013|C|COMMON BRAND NAME(S): ISMO, Monoket||
5048|014|B|||
5048|015|U|USES:  Isosorbide mononitrate is used to prevent chest pain||
5048|016|U|(angina) in patients with a certain heart condition (coronary||
5048|017|U|artery disease). This medication belongs to a class of drugs||
5048|018|U|known as nitrates. It works by relaxing and widening blood||
5048|019|U|vessels so blood can flow more easily to the heart.||
5048|020|U|   This medication will not relieve chest pain once it occurs.||
5048|021|U|Also, it is not intended to be taken just before physical||
5048|022|U|activities (such as exercise or sexual intercourse) to prevent||
5048|023|U|chest pain. Other medications may be prescribed by your doctor||
5048|024|U|for these conditions. Consult your doctor for more details.||
5048|025|B|||
5048|026|H|HOW TO USE:  Take this medication by mouth as directed by your||
5048|027|H|doctor, usually twice a day. Each day, take the first dose when||
5048|028|H|you wake up, then take the second dose 7 hours later. It is||
5048|029|H|important to take the drug at the same times each day. Do not||
5048|030|H|change the dosing times unless directed by your doctor.||
5048|031|H|   Use this medication regularly to get the most benefit from it.||
5048|032|H|To help you remember, take it at the same times each day. Do not||
5048|033|H|stop taking it without consulting your doctor. Some conditions||
5048|034|H|may become worse when the drug is suddenly stopped. Your dose may||
5048|035|H|need to be gradually decreased.||
5048|036|H|   Although unlikely, when this medication is used for a long||
5048|037|H|time, it may not work as well and may require different dosing.||
5048|038|H|Tell your doctor if this medication stops working well (for||
5048|039|H|example, you have more frequent or worsening chest pain).||
5048|040|B|||
5048|041|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, nausea, and||
5048|042|S|flushing may occur as your body adjusts to this medication. If||
5048|043|S|any of these effects last or get worse, tell your doctor or||
5048|044|S|pharmacist promptly.||
5048|045|S|   Headache is often a sign that this medication is working. Your||
5048|046|S|doctor may recommend treating headaches with an over-the-counter||
5048|047|S|pain reliever (such as acetaminophen, aspirin). If headaches||
5048|048|S|continue or become severe, tell your doctor promptly.||
5048|049|S|   To reduce the risk of dizziness and lightheadedness, get up||
5048|050|S|slowly when rising from a sitting or lying position.||
5048|051|S|   Remember that this medication has been prescribed because your||
5048|052|S|doctor has judged that the benefit to you is greater than the||
5048|053|S|risk of side effects. Many people using this medication do not||
5048|054|S|have serious side effects.||
5048|055|S|   Tell your doctor right away if you have any serious side||
5048|056|S|effects, including: fainting, fast/irregular/pounding heartbeat.||
5048|057|S|   A very serious allergic reaction to this drug is rare.||
5048|058|S|However, get medical help right away if you notice any symptoms||
5048|059|S|of a serious allergic reaction, including: rash, itching/swelling||
5048|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5048|061|S|breathing.||
5048|062|S|   This is not a complete list of possible side effects. If you||
5048|063|S|notice other effects not listed above, contact your doctor or||
5048|064|S|pharmacist.||
5048|065|S|   In the US -||
5048|066|S|   Call your doctor for medical advice about side effects. You||
5048|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5048|068|S|www.fda.gov/medwatch.||
5048|069|S|   In Canada - Call your doctor for medical advice about side||
5048|070|S|effects. You may report side effects to Health Canada at||
5048|071|S|1-866-234-2345.||
5048|072|B|||
5048|073|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
5048|074|P|pharmacist if you are allergic to it; or to similar drugs (such||
5048|075|P|as isosorbide dinitrate, nitroglycerin); or if you have any other||
5048|076|P|allergies. This product may contain inactive ingredients, which||
5048|077|P|can cause allergic reactions or other problems. Talk to your||
5048|078|P|pharmacist for more details.||
5048|079|P|   Before using this medication, tell your doctor or pharmacist||
5048|080|P|your medical history, especially of: low blood pressure.||
5048|081|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5048|082|P|can make you more dizzy. Do not drive, use machinery, or do||
5048|083|P|anything that needs alertness until you can do it safely. Limit||
5048|084|P|alcoholic beverages. Talk to your doctor if you are using||
5048|085|P|marijuana (cannabis).||
5048|086|P|   Before having surgery, tell your doctor or dentist about all||
5048|087|P|the products you use (including prescription drugs,||
5048|088|P|nonprescription drugs, and herbal products).||
5048|089|P|   Older adults may be more sensitive to the side effects of this||
5048|090|P|medication, especially dizziness and lightheadedness, which could||
5048|091|P|increase the risk of falls.||
5048|092|P|   During pregnancy, this medication should be used only when||
5048|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
5048|094|P|   It is unknown if this medication passes into breast milk.||
5048|095|P|Consult your doctor before breastfeeding.||
5048|096|B|||
5048|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5048|098|I|medications work or increase your risk for serious side effects.||
5048|099|I|This document does not contain all possible drug interactions.||
5048|100|I|Keep a list of all the products you use (including||
5048|101|I|prescription/nonprescription drugs and herbal products) and share||
5048|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
5048|103|I|the dosage of any medicines without your doctor's approval.||
5048|104|I|   Some products that may interact with this drug include: drugs||
5048|105|I|to treat erectile dysfunction-ED or pulmonary hypertension (such||
5048|106|I|as sildenafil, tadalafil), riociguat, vericiguat.||
5048|107|I|   Some products have ingredients that could worsen your heart||
5048|108|I|failure. Tell your pharmacist what products you are using, and||
5048|109|I|ask how to use them safely (especially cough-and-cold products,||
5048|110|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
5048|111|I|   Isosorbide mononitrate is very similar to isosorbide||
5048|112|I|dinitrate. Do not use medications containing isosorbide dinitrate||
5048|113|I|while using isosorbide mononitrate.||
5048|114|I|   This medication may interfere with certain lab tests (such as||
5048|115|I|cholesterol levels), possibly causing false test results. Make||
5048|116|I|sure lab personnel and all your doctors know you use this drug.||
5048|117|B|||
5048|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5048|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5048|120|O|poison control center right away. US residents can call||
5048|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5048|122|O|Symptoms of overdose may include: slow heartbeat, vision changes,||
5048|123|O|severe nausea/vomiting, sweating, cold/clammy skin, bluish||
5048|124|O|fingers/toes/lips.||
5048|125|B|||
5048|126|N|NOTES:  Do not share this medication with others.||
5048|127|N|   Lab and/or medical tests (such as blood pressure) should be||
5048|128|N|done while you are taking this medication. Keep all medical and||
5048|129|N|lab appointments. Consult your doctor for more details.||
5048|130|N|   Lifestyle changes such as dietary changes, exercise, and not||
5048|131|N|smoking may help this drug work better. Talk to your doctor or||
5048|132|N|pharmacist about lifestyle changes that might benefit you.||
5048|133|B|||
5048|134|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5048|135|D|remember. If it is within 2 hours of the next dose, skip the||
5048|136|D|missed dose. Take your next dose at the regular time. Do not||
5048|137|D|double the dose to catch up.||
5048|138|B|||
5048|139|R|STORAGE:  Store at room temperature away from light and moisture.||
5048|140|R|Do not store in the bathroom. Keep all medications away from||
5048|141|R|children and pets.||
5048|142|R|   Do not flush medications down the toilet or pour them into a||
5048|143|R|drain unless instructed to do so. Properly discard this product||
5048|144|R|when it is expired or no longer needed. Consult your pharmacist||
5048|145|R|or local waste disposal company.||
5048|146|B|||
5048|147|M|MEDICAL ALERT:  Your condition can cause complications in a||
5048|148|M|medical emergency. For information about enrolling in MedicAlert,||
5048|149|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5048|150|B|||
5048|151|A|Information last revised May 2024.||
5048|152|A|Copyright(c) 2025 First Databank, Inc.||
5048|153|B|||
5049|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5049|002|Z|does NOT have all possible information about this product. This||
5049|003|Z|information does not assure that this product is safe, effective,||
5049|004|Z|or appropriate for you. This information is not individual||
5049|005|Z|medical advice and does not substitute for the advice of your||
5049|006|Z|health care professional. Always ask your health care||
5049|007|Z|professional for complete information about this product and your||
5049|008|Z|specific health needs.||
5049|009|B|||
5049|010|T|NABUMETONE - ORAL||
5049|011|F|(nab-YOU-meh-tone)||
5049|012|B|||
5049|013|C|COMMON BRAND NAME(S): Relafen||
5049|014|B|||
5049|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
5049|016|W|nabumetone) may rarely increase the risk for a heart attack or||
5049|017|W|stroke. This effect can happen at any time while taking this drug||
5049|018|W|but is more likely if you take it for a long time. The risk may||
5049|019|W|be greater in older adults or if you have heart disease or||
5049|020|W|increased risk for heart disease (for example, due to smoking,||
5049|021|W|family history of heart disease, or conditions such as high blood||
5049|022|W|pressure or diabetes). Do not take this drug right before or||
5049|023|W|after heart bypass surgery (CABG).||
5049|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
5049|025|W|bleeding from the stomach or intestines. This effect can occur||
5049|026|W|without warning symptoms at any time while taking this drug.||
5049|027|W|Older adults may be at higher risk for this effect. (See also||
5049|028|W|Precautions and Drug Interactions sections.)||
5049|029|W|   Stop taking nabumetone and get medical help right away if you||
5049|030|W|notice any of the following rare but serious side effects:||
5049|031|W|stomach/abdominal pain that doesn't go away, bloody or||
5049|032|W|black/tarry stools, vomit that looks like coffee grounds,||
5049|033|W|chest/jaw/left arm pain, shortness of breath, unusual sweating,||
5049|034|W|weakness on one side of the body, sudden vision changes, trouble||
5049|035|W|speaking.||
5049|036|W|   Talk with your doctor or pharmacist about the risks and||
5049|037|W|benefits of treatment with this medication.||
5049|038|B|||
5049|039|U|USES:  Nabumetone is used to reduce pain, swelling, and joint||
5049|040|U|stiffness from arthritis. This medication is known as a||
5049|041|U|nonsteroidal anti-inflammatory drug (NSAID).||
5049|042|U|   If you are treating a chronic condition such as arthritis, ask||
5049|043|U|your doctor about non-drug treatments and/or using other||
5049|044|U|medications to treat your pain. See also Warning section.||
5049|045|B|||
5049|046|V|OTHER USES:  This section contains uses of this drug that are not||
5049|047|V|listed in the approved professional labeling for the drug but||
5049|048|V|that may be prescribed by your health care professional. Use this||
5049|049|V|drug for a condition that is listed in this section only if it||
5049|050|V|has been so prescribed by your health care professional.||
5049|051|V|   This drug may also be used for gout attacks.||
5049|052|B|||
5049|053|H|HOW TO USE:  Read the Medication Guide provided by your||
5049|054|H|pharmacist before you start using nabumetone and each time you||
5049|055|H|get a refill. If you have any questions, ask your doctor or||
5049|056|H|pharmacist.||
5049|057|H|   Take this medication by mouth as directed by your doctor,||
5049|058|H|usually once or twice daily with a full glass of water (8 ounces||
5049|059|H|or 240 milliliters). Do not lie down for at least 10 minutes||
5049|060|H|after taking this drug. To prevent stomach upset, take it with||
5049|061|H|food, milk, or an antacid.||
5049|062|H|   The dosage is based on your medical condition and response to||
5049|063|H|treatment. To minimize side effect risks (such as stomach||
5049|064|H|bleeding), use this medication at the lowest effective dose for||
5049|065|H|the shortest possible length of time. Do not increase your dose||
5049|066|H|or take it more often than prescribed. For chronic conditions||
5049|067|H|such as arthritis, keep taking it as directed by your doctor.||
5049|068|H|Discuss the risks and benefits with your doctor or pharmacist.||
5049|069|H|   In certain conditions (such as arthritis), it may take up to 2||
5049|070|H|weeks when this drug is taken regularly before you notice the||
5049|071|H|full benefits.||
5049|072|H|   If you are taking this drug on an "as needed" basis (not on a||
5049|073|H|regular schedule), remember that pain medications work best if||
5049|074|H|they are used as the first signs of pain occur. If you wait until||
5049|075|H|the pain has worsened, the medication may not work as well.||
5049|076|H|   Tell your doctor if your condition gets worse.||
5049|077|B|||
5049|078|S|SIDE EFFECTS:  See also Warning section.||
5049|079|S|   Upset stomach, nausea, vomiting, constipation, diarrhea, gas,||
5049|080|S|dizziness, drowsiness, or headache may occur. If any of these||
5049|081|S|effects last or get worse, tell your doctor or pharmacist||
5049|082|S|promptly.||
5049|083|S|   Remember that this medication has been prescribed because your||
5049|084|S|doctor has judged that the benefit to you is greater than the||
5049|085|S|risk of side effects. Many people using this medication do not||
5049|086|S|have serious side effects.||
5049|087|S|   This medication may raise your blood pressure. Check your||
5049|088|S|blood pressure regularly and tell your doctor if the results are||
5049|089|S|high.||
5049|090|S|   Tell your doctor right away if you have any serious side||
5049|091|S|effects, including: hearing changes (such as ringing in the||
5049|092|S|ears), mental/mood changes, difficult/painful swallowing, signs||
5049|093|S|of kidney problems (such as change in the amount of urine),||
5049|094|S|symptoms of heart failure (such as swelling ankles/feet, unusual||
5049|095|S|tiredness, unusual/sudden weight gain).||
5049|096|S|   This drug may rarely cause serious (possibly fatal) liver||
5049|097|S|disease. If you notice any of the following highly unlikely but||
5049|098|S|very serious side effects, stop taking nabumetone and consult||
5049|099|S|your doctor or pharmacist right away: nausea/vomiting that||
5049|100|S|doesn't stop, dark urine, severe stomach/abdominal pain,||
5049|101|S|yellowing eyes/skin.||
5049|102|S|   A very serious allergic reaction to this drug is rare.||
5049|103|S|However, get medical help right away if you notice any symptoms||
5049|104|S|of a serious allergic reaction, including: fever, swollen lymph||
5049|105|S|nodes, rash, itching/swelling (especially of the||
5049|106|S|face/tongue/throat), severe dizziness, trouble breathing.||
5049|107|S|   This is not a complete list of possible side effects. If you||
5049|108|S|notice other effects not listed above, contact your doctor or||
5049|109|S|pharmacist.||
5049|110|S|   In the US -||
5049|111|S|   Call your doctor for medical advice about side effects. You||
5049|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5049|113|S|www.fda.gov/medwatch.||
5049|114|S|   In Canada - Call your doctor for medical advice about side||
5049|115|S|effects. You may report side effects to Health Canada at||
5049|116|S|1-866-234-2345.||
5049|117|B|||
5049|118|P|PRECAUTIONS:  See also Warning section.||
5049|119|P|   Before taking nabumetone, tell your doctor or pharmacist if||
5049|120|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
5049|121|P|ibuprofen, naproxen, celecoxib); or if you have any other||
5049|122|P|allergies. This product may contain inactive ingredients, which||
5049|123|P|can cause allergic reactions or other problems. Talk to your||
5049|124|P|pharmacist for more details.||
5049|125|P|   Before using this medication, tell your doctor or pharmacist||
5049|126|P|your medical history, especially of: asthma (including a history||
5049|127|P|of worsening breathing after taking aspirin or other NSAIDs),||
5049|128|P|bleeding or clotting problems, growths in the nose (nasal||
5049|129|P|polyps), heart disease (such as previous heart attack), high||
5049|130|P|blood pressure, liver disease, stroke,||
5049|131|P|stomach/intestinal/esophagus problems (such as bleeding, ulcers,||
5049|132|P|recurring heartburn).||
5049|133|P|   Kidney problems can sometimes occur with the use of NSAID||
5049|134|P|medications, including nabumetone. Problems are more likely to||
5049|135|P|occur if you are dehydrated, have heart failure or kidney||
5049|136|P|disease, are an older adult, or if you take certain medications||
5049|137|P|(see also Drug Interactions section). Drink plenty of fluids as||
5049|138|P|directed by your doctor to prevent dehydration and tell your||
5049|139|P|doctor right away if you have a change in the amount of urine.||
5049|140|P|   Before having surgery, tell your doctor or dentist about all||
5049|141|P|the products you use (including prescription drugs,||
5049|142|P|nonprescription drugs, and herbal products).||
5049|143|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5049|144|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5049|145|P|machinery, or do anything that needs alertness until you can do||
5049|146|P|it safely. Talk to your doctor if you are using marijuana||
5049|147|P|(cannabis).||
5049|148|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
5049|149|P|and tobacco, especially when combined with this medicine, may||
5049|150|P|increase your risk for stomach bleeding. Limit alcohol and stop||
5049|151|P|smoking. Consult your doctor or pharmacist for more information.||
5049|152|P|   This medication may make you more sensitive to the sun. Limit||
5049|153|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5049|154|P|sunscreen and wear protective clothing when outdoors. Tell your||
5049|155|P|doctor right away if you get sunburned or have skin||
5049|156|P|blisters/redness.||
5049|157|P|   Older adults may be at greater risk for stomach/intestinal||
5049|158|P|bleeding, kidney problems, heart attack, and stroke while using||
5049|159|P|this drug.||
5049|160|P|   Before using this medication, women of childbearing age should||
5049|161|P|talk with their doctor(s) about the benefits and risks. Tell your||
5049|162|P|doctor if you are pregnant or if you plan to become pregnant.||
5049|163|P|This medication may harm an unborn baby and cause problems with||
5049|164|P|normal labor/delivery. It is not recommended for use in pregnancy||
5049|165|P|from 20 weeks until delivery. If your doctor decides that you||
5049|166|P|need to use this medication between 20 and 30 weeks of pregnancy,||
5049|167|P|you should use the lowest effective dose for the shortest||
5049|168|P|possible time. You should not use this medication after 30 weeks||
5049|169|P|of pregnancy.||
5049|170|P|   It is unknown if this drug passes into breast milk. Consult||
5049|171|P|your doctor before breastfeeding.||
5049|172|B|||
5049|173|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5049|174|I|medications work or increase your risk for serious side effects.||
5049|175|I|This document does not contain all possible drug interactions.||
5049|176|I|Keep a list of all the products you use (including||
5049|177|I|prescription/nonprescription drugs and herbal products) and share||
5049|178|I|it with your doctor and pharmacist. Do not start, stop, or change||
5049|179|I|the dosage of any medicines without your doctor's approval.||
5049|180|I|   Some products that may interact with this drug include:||
5049|181|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
5049|182|I|angiotensin II receptor blockers (such as losartan, valsartan),||
5049|183|I|cidofovir, corticosteroids (such as prednisone), lithium,||
5049|184|I|methotrexate, "water pills" (diuretics such as furosemide).||
5049|185|I|   This medication may increase the risk of bleeding when taken||
5049|186|I|with other drugs that also may cause bleeding. Examples include||
5049|187|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
5049|188|I|dabigatran/enoxaparin/warfarin, among others.||
5049|189|I|   Check all prescription and nonprescription medicine labels||
5049|190|I|carefully since many medications contain pain relievers/fever||
5049|191|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
5049|192|I|ketorolac). These drugs are similar to nabumetone and may||
5049|193|I|increase your risk of side effects if taken together. However, if||
5049|194|I|your doctor has told you to take low-dose aspirin to prevent||
5049|195|I|heart attack or stroke (usually 81-162 milligrams a day), you||
5049|196|I|should keep taking the aspirin unless your doctor tells you not||
5049|197|I|to. Ask your doctor or pharmacist for more details.||
5049|198|B|||
5049|199|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5049|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5049|201|O|poison control center right away. US residents can call||
5049|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5049|203|O|Symptoms of overdose may include: severe stomach pain, vomit that||
5049|204|O|looks like coffee grounds, extreme drowsiness, loss of||
5049|205|O|consciousness, slowed or shallow breathing.||
5049|206|B|||
5049|207|N|NOTES:  Do not share this medication with others.||
5049|208|N|   Lab and/or medical tests (such as blood pressure, complete||
5049|209|N|blood count, liver/kidney function) may be done while you are||
5049|210|N|taking this medication. Keep all medical and lab appointments.||
5049|211|N|Consult your doctor for more details.||
5049|212|N|   Non-drug treatment for arthritis that is approved by your||
5049|213|N|doctor (such as weight loss if needed, strengthening and||
5049|214|N|conditioning exercises) may help improve your flexibility, range||
5049|215|N|of motion, and joint function. Consult your doctor for specific||
5049|216|N|instructions.||
5049|217|B|||
5049|218|D|MISSED DOSE:  If you are prescribed this drug on a regular||
5049|219|D|schedule (not just "as needed") and you miss a dose, take it as||
5049|220|D|soon as you remember. If it is near the time of the next dose,||
5049|221|D|skip the missed dose. Take your next dose at the regular time. Do||
5049|222|D|not double the dose to catch up.||
5049|223|B|||
5049|224|R|STORAGE:  Store at room temperature away from light and moisture.||
5049|225|R|Do not store in the bathroom. Keep all medications away from||
5049|226|R|children and pets.||
5049|227|R|   Do not flush medications down the toilet or pour them into a||
5049|228|R|drain unless instructed to do so. Properly discard this product||
5049|229|R|when it is expired or no longer needed. Consult your pharmacist||
5049|230|R|or local waste disposal company.||
5049|231|B|||
5049|232|A|Information last revised May 2025.||
5049|233|A|Copyright(c) 2025 First Databank, Inc.||
5049|234|B|||
5050|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5050|002|Z|does NOT have all possible information about this product. This||
5050|003|Z|information does not assure that this product is safe, effective,||
5050|004|Z|or appropriate for you. This information is not individual||
5050|005|Z|medical advice and does not substitute for the advice of your||
5050|006|Z|health care professional. Always ask your health care||
5050|007|Z|professional for complete information about this product and your||
5050|008|Z|specific health needs.||
5050|009|B|||
5050|010|T|AMOXICILLIN/CLAVULANIC ACID SUSPENSION - ORAL||
5050|011|F|(a-MOX-i-SIL-in/KLAV-ue-LAN-ik AS-id)||
5050|012|B|||
5050|013|C|COMMON BRAND NAME(S): Augmentin||
5050|014|B|||
5050|015|U|USES:  Amoxicillin/clavulanic acid is a combination||
5050|016|U|penicillin-type antibiotic used to treat a wide variety of||
5050|017|U|bacterial infections. It works by stopping the growth of||
5050|018|U|bacteria.||
5050|019|U|   This antibiotic treats only bacterial infections. It will not||
5050|020|U|work for viral infections (such as common cold, flu). Using any||
5050|021|U|antibiotic when it is not needed can cause it to not work for||
5050|022|U|future infections.||
5050|023|B|||
5050|024|H|HOW TO USE:  Shake the bottle well before each dose. Carefully||
5050|025|H|measure the dose using a special measuring device/spoon. Do not||
5050|026|H|use a household spoon because you may not get the correct dose.||
5050|027|H|Take this medication with a meal or snack as directed by the||
5050|028|H|doctor. Depending on your specific product, this medication is||
5050|029|H|usually taken every 8 or 12 hours.||
5050|030|H|   The dosage is based on your age, weight, medical condition,||
5050|031|H|and response to treatment.||
5050|032|H|   For the best effect, take this antibiotic at evenly spaced||
5050|033|H|times. To help you remember, take this medication at the same||
5050|034|H|time(s) every day.||
5050|035|H|   Continue to take this medication until the full prescribed||
5050|036|H|amount is finished, even if symptoms disappear after a few days.||
5050|037|H|Stopping the medication too early may result in a return of the||
5050|038|H|infection.||
5050|039|H|   Tell the doctor if your condition lasts or gets worse.||
5050|040|B|||
5050|041|S|SIDE EFFECTS:  Diarrhea, nausea, or vomiting may occur. If any of||
5050|042|S|these effects last or get worse, tell the doctor or pharmacist||
5050|043|S|promptly. Taking this medication with food will help to reduce||
5050|044|S|stomach upset.||
5050|045|S|   Remember that this medication has been prescribed because your||
5050|046|S|doctor has judged that the benefit to you is greater than the||
5050|047|S|risk of side effects. Many people using this medication do not||
5050|048|S|have serious side effects.||
5050|049|S|   Tell your doctor right away if you have any serious side||
5050|050|S|effects, including: signs of liver disease (such as||
5050|051|S|nausea/vomiting that doesn't stop, loss of appetite,||
5050|052|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
5050|053|S|bruising/bleeding, unusual tiredness.||
5050|054|S|   This medication may rarely cause a severe intestinal condition||
5050|055|S|due to a bacteria called C. difficile. This condition may occur||
5050|056|S|during treatment or weeks to months after treatment has stopped.||
5050|057|S|Tell your doctor right away if you develop: diarrhea that doesn't||
5050|058|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
5050|059|S|stool.||
5050|060|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
5050|061|S|products because they may make symptoms worse.||
5050|062|S|   Use of this medication for prolonged or repeated periods may||
5050|063|S|result in oral thrush or a new yeast infection. Contact the||
5050|064|S|doctor if you notice white patches in your mouth, a change in||
5050|065|S|vaginal discharge or other new symptoms.||
5050|066|S|   A very serious allergic reaction to this drug is rare.||
5050|067|S|However, get medical help right away if you notice any symptoms||
5050|068|S|of a serious allergic reaction, including: fever that doesn't go||
5050|069|S|away, new or worsening lymph node swelling, rash,||
5050|070|S|itching/swelling (especially of the face/tongue/throat), severe||
5050|071|S|dizziness, trouble breathing.||
5050|072|S|   Amoxicillin can commonly cause a mild rash that is usually not||
5050|073|S|serious. However, you may not be able to tell it apart from a||
5050|074|S|rare rash that could be a sign of a severe allergic reaction. Get||
5050|075|S|medical help right away if you develop any rash.||
5050|076|S|   This is not a complete list of possible side effects. If you||
5050|077|S|notice other effects not listed above, contact the doctor or||
5050|078|S|pharmacist.||
5050|079|S|   In the US -||
5050|080|S|   Call your doctor for medical advice about side effects. You||
5050|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5050|082|S|www.fda.gov/medwatch.||
5050|083|S|   In Canada - Call your doctor for medical advice about side||
5050|084|S|effects. You may report side effects to Health Canada at||
5050|085|S|1-866-234-2345.||
5050|086|B|||
5050|087|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
5050|088|P|pharmacist if you are allergic to amoxicillin or clavulanic acid;||
5050|089|P|or to penicillin or cephalosporin antibiotics; or if you have any||
5050|090|P|other allergies. This product may contain inactive ingredients,||
5050|091|P|which can cause allergic reactions or other problems. Talk to||
5050|092|P|your pharmacist for more details.||
5050|093|P|   Before using this medication, tell the doctor or pharmacist||
5050|094|P|your medical history, especially of: liver disease (including||
5050|095|P|liver problems caused by previous use of amoxicillin/clavulanic||
5050|096|P|acid), kidney disease, a certain type of viral infection||
5050|097|P|(infectious mononucleosis).||
5050|098|P|   This medication may contain aspartame. If you have||
5050|099|P|phenylketonuria (PKU) or any other condition that requires you to||
5050|100|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
5050|101|P|doctor or pharmacist about using this medication safely.||
5050|102|P|   Before having surgery, tell your doctor or dentist about all||
5050|103|P|the products you use (including prescription drugs,||
5050|104|P|nonprescription drugs, and herbal products).||
5050|105|P|   This product may cause live bacterial vaccines (such as||
5050|106|P|typhoid vaccine) to not work well. Tell your health care||
5050|107|P|professional that you are using this medication before having any||
5050|108|P|immunizations/vaccinations.||
5050|109|P|   During pregnancy, this medication should be used only when||
5050|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
5050|111|P|   This medication passes into breast milk. Consult your doctor||
5050|112|P|before breastfeeding.||
5050|113|B|||
5050|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5050|115|I|medications work or increase your risk for serious side effects.||
5050|116|I|This document does not contain all possible drug interactions.||
5050|117|I|Keep a list of all the products you use (including||
5050|118|I|prescription/nonprescription drugs and herbal products) and share||
5050|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
5050|120|I|the dosage of any medicines without your doctor's approval.||
5050|121|I|   A product that may interact with this drug is: methotrexate.||
5050|122|I|   This medication may interfere with certain lab tests (such as||
5050|123|I|certain urine glucose tests), possibly causing false test||
5050|124|I|results. Make sure lab personnel and all your doctors know you||
5050|125|I|use this drug.||
5050|126|B|||
5050|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5050|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5050|129|O|poison control center right away. US residents can call||
5050|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5050|131|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
5050|132|O|severe vomiting, change in the amount of urine.||
5050|133|B|||
5050|134|N|NOTES:  Do not share this medication with others.||
5050|135|N|   This medication has been prescribed for your current condition||
5050|136|N|only. Do not use it later for another infection unless your||
5050|137|N|doctor tells you to.||
5050|138|N|   With long-term treatment, lab and/or medical tests (such as||
5050|139|N|kidney/liver function, complete blood counts) may be done while||
5050|140|N|you are taking this medication. Keep all medical and lab||
5050|141|N|appointments. Consult your doctor for more details.||
5050|142|B|||
5050|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5050|144|D|remember. If it is near the time of the next dose, skip the||
5050|145|D|missed dose. Take your next dose at the regular time. Do not||
5050|146|D|double the dose to catch up.||
5050|147|B|||
5050|148|R|STORAGE:  Refrigerate the suspension. The unused portion of some||
5050|149|R|brands should be discarded after 7 days. For other brands, the||
5050|150|R|unused portion should be discarded after 10 days. Check with your||
5050|151|R|pharmacist regarding your specific brand and how long to store it||
5050|152|R|before discarding. Keep all medications away from children and||
5050|153|R|pets.||
5050|154|R|   Do not flush medications down the toilet or pour them into a||
5050|155|R|drain unless instructed to do so. Properly discard this product||
5050|156|R|when it is expired or no longer needed. Consult your pharmacist||
5050|157|R|or local waste disposal company.||
5050|158|B|||
5050|159|A|Information last revised May 2024.||
5050|160|A|Copyright(c) 2025 First Databank, Inc.||
5050|161|B|||
5051|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5051|002|Z|does NOT have all possible information about this product. This||
5051|003|Z|information does not assure that this product is safe, effective,||
5051|004|Z|or appropriate for you. This information is not individual||
5051|005|Z|medical advice and does not substitute for the advice of your||
5051|006|Z|health care professional. Always ask your health care||
5051|007|Z|professional for complete information about this product and your||
5051|008|Z|specific health needs.||
5051|009|B|||
5051|010|T|ZOLMITRIPTAN - ORAL||
5051|011|F|(ZOLE-mi-TRIP-tan)||
5051|012|B|||
5051|013|C|COMMON BRAND NAME(S): Zomig||
5051|014|B|||
5051|015|U|USES:  Zolmitriptan is used to treat migraines. It helps to||
5051|016|U|relieve headache, pain, and other migraine symptoms (including||
5051|017|U|nausea, vomiting, sensitivity to light/sound). Prompt treatment||
5051|018|U|helps you return to your normal routine and may decrease your||
5051|019|U|need for other pain medications. Zolmitriptan belongs to a class||
5051|020|U|of drugs known as triptans. It affects a certain natural||
5051|021|U|substance (serotonin) that causes narrowing of blood vessels in||
5051|022|U|the brain. It may also relieve pain by affecting certain nerves||
5051|023|U|in the brain.||
5051|024|U|   Zolmitriptan does not prevent future migraines or lessen how||
5051|025|U|often you get migraine attacks.||
5051|026|B|||
5051|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5051|028|H|from your pharmacist before you start taking zolmitriptan and||
5051|029|H|each time you get a refill. If you have any questions, ask your||
5051|030|H|doctor or pharmacist.||
5051|031|H|   Take this medication by mouth with or without food as directed||
5051|032|H|by your doctor, at the first sign of a migraine. The dosage is||
5051|033|H|based on your medical condition, response to treatment, and other||
5051|034|H|medications you may be taking. Be sure to tell your doctor about||
5051|035|H|all the products you use, including prescription drugs,||
5051|036|H|nonprescription drugs, and herbal products.||
5051|037|H|   If there is no improvement in your symptoms, do not take more||
5051|038|H|doses of this medication before talking to your doctor. If your||
5051|039|H|symptoms are only partly relieved, or if your headache comes||
5051|040|H|back, you may take another dose at least two hours after the||
5051|041|H|first dose. Do not take more than 10 milligrams in a 24-hour||
5051|042|H|period. Some patients may be directed to not take more than 5||
5051|043|H|milligrams in a 24-hour period. Follow your doctor's instructions||
5051|044|H|carefully.||
5051|045|H|   If you have a higher risk for heart problems (see||
5051|046|H|Precautions), your doctor may perform a heart exam before you||
5051|047|H|start taking zolmitriptan. He/she may also direct you to take||
5051|048|H|your first dose of this medication in the office/clinic to||
5051|049|H|monitor for serious side effects (such as chest pain). Talk to||
5051|050|H|your doctor for details.||
5051|051|H|   If you are using drugs for migraine attacks on 10 or more days||
5051|052|H|each month, the drugs may actually make your headaches worse||
5051|053|H|(medication overuse headache). Do not use medications more often||
5051|054|H|or for longer than directed. Tell your doctor if you need to use||
5051|055|H|this medication more often, or if the medication is not working||
5051|056|H|as well, or if your headaches get worse.||
5051|057|B|||
5051|058|S|SIDE EFFECTS:  Tingling/numbness, nausea, dry mouth, weakness,||
5051|059|S|drowsiness, or dizziness may occur. If any of these effects last||
5051|060|S|or get worse, tell your doctor or pharmacist promptly.||
5051|061|S|   Remember that this medication has been prescribed because your||
5051|062|S|doctor has judged that the benefit to you is greater than the||
5051|063|S|risk of side effects. Many people using this medication do not||
5051|064|S|have serious side effects.||
5051|065|S|   This medication may raise your blood pressure. Check your||
5051|066|S|blood pressure regularly and tell your doctor if the results are||
5051|067|S|high.||
5051|068|S|   Tell your doctor right away if you have any serious side||
5051|069|S|effects, including: blue fingers/toes/nails, cold hands/feet.||
5051|070|S|   Zolmitriptan can commonly cause chest/jaw/neck tightness,||
5051|071|S|pain, or pressure that is usually not serious. However, these||
5051|072|S|side effects are like symptoms of a heart attack, which may||
5051|073|S|include chest/jaw/left arm pain, shortness of breath, or unusual||
5051|074|S|sweating. Get medical help right away if these or other serious||
5051|075|S|side effects occur, including: fast/irregular heartbeat,||
5051|076|S|fainting, severe stomach/abdominal pain, bloody diarrhea, signs||
5051|077|S|of a stroke (such as weakness on one side of the body, trouble||
5051|078|S|speaking, sudden vision changes, confusion).||
5051|079|S|   This medication may increase serotonin and rarely cause a very||
5051|080|S|serious condition called serotonin syndrome/toxicity. The risk||
5051|081|S|increases if you are also taking other drugs that increase||
5051|082|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
5051|083|S|take (see Drug Interactions section). Get medical help right away||
5051|084|S|if you develop some of the following symptoms: fast heartbeat,||
5051|085|S|hallucinations, loss of coordination, severe dizziness, severe||
5051|086|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
5051|087|S|unusual agitation/restlessness.||
5051|088|S|   A very serious allergic reaction to this drug is rare.||
5051|089|S|However, get medical help right away if you notice any symptoms||
5051|090|S|of a serious allergic reaction, including: rash, itching/swelling||
5051|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5051|092|S|breathing.||
5051|093|S|   This is not a complete list of possible side effects. If you||
5051|094|S|notice other effects not listed above, contact your doctor or||
5051|095|S|pharmacist.||
5051|096|S|   In the US -||
5051|097|S|   Call your doctor for medical advice about side effects. You||
5051|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5051|099|S|www.fda.gov/medwatch.||
5051|100|S|   In Canada - Call your doctor for medical advice about side||
5051|101|S|effects. You may report side effects to Health Canada at||
5051|102|S|1-866-234-2345.||
5051|103|B|||
5051|104|P|PRECAUTIONS:  Before using zolmitriptan, tell your doctor or||
5051|105|P|pharmacist if you are allergic to it; or if you have any other||
5051|106|P|allergies. This product may contain inactive ingredients, which||
5051|107|P|can cause allergic reactions or other problems. Talk to your||
5051|108|P|pharmacist for more details.||
5051|109|P|   Before using this medication, tell your doctor or pharmacist||
5051|110|P|your medical history, especially of: blood circulation problems||
5051|111|P|(for example, in your legs, arms/hands, or stomach), certain||
5051|112|P|types of headaches (hemiplegic or basilar migraine), heart||
5051|113|P|problems (such as chest pain, irregular heartbeat, previous heart||
5051|114|P|attack), liver disease, seizure, stroke or "mini-stroke"||
5051|115|P|(transient ischemic attack).||
5051|116|P|   Certain conditions can increase your risk for heart problems.||
5051|117|P|Tell your doctor if you have any of these conditions, including:||
5051|118|P|high blood pressure, high cholesterol, diabetes, family history||
5051|119|P|of heart disease, overweight, smoker, postmenopausal (women), age||
5051|120|P|more than 40 years (men).||
5051|121|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5051|122|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5051|123|P|machinery, or do anything that needs alertness until you can do||
5051|124|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5051|125|P|are using marijuana (cannabis).||
5051|126|P|   Before having surgery, tell your doctor or dentist about all||
5051|127|P|the products you use (including prescription drugs,||
5051|128|P|nonprescription drugs, and herbal products).||
5051|129|P|   The risk of heart disease, liver disease, and high blood||
5051|130|P|pressure increases with age. Older adults may be more sensitive||
5051|131|P|to the side effects of this drug, especially increased blood||
5051|132|P|pressure and heart problems.||
5051|133|P|   During pregnancy, this medication should be used only when||
5051|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
5051|135|P|   It is unknown if this drug passes into breast milk. Consult||
5051|136|P|your doctor before breastfeeding.||
5051|137|B|||
5051|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5051|139|I|medications work or increase your risk for serious side effects.||
5051|140|I|This document does not contain all possible drug interactions.||
5051|141|I|Keep a list of all the products you use (including||
5051|142|I|prescription/nonprescription drugs and herbal products) and share||
5051|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
5051|144|I|the dosage of any medicines without your doctor's approval.||
5051|145|I|   Taking MAO inhibitors with this medication may cause a serious||
5051|146|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
5051|147|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
5051|148|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
5051|149|I|selegiline, tranylcypromine) during treatment with this||
5051|150|I|medication. Most MAO inhibitors should also not be taken for two||
5051|151|I|weeks before treatment with this medication. Ask your doctor when||
5051|152|I|to start or stop taking this medication.||
5051|153|I|   The risk of serotonin syndrome/toxicity increases if you are||
5051|154|I|also taking other drugs that increase serotonin. Examples include||
5051|155|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
5051|156|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
5051|157|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
5051|158|I|serotonin syndrome/toxicity may be more likely when you start or||
5051|159|I|increase the dose of these drugs.||
5051|160|I|   If you also take any ergotamine medication (such as||
5051|161|I|dihydroergotamine) or other "triptan" drugs (such as sumatriptan,||
5051|162|I|rizatriptan), you will need to separate your zolmitriptan dose||
5051|163|I|from your dose of these other medications to lessen the chance of||
5051|164|I|serious side effects. Ask your doctor how long you should wait||
5051|165|I|between your doses of these drugs.||
5051|166|B|||
5051|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5051|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5051|169|O|poison control center right away. US residents can call||
5051|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5051|171|B|||
5051|172|N|NOTES:  Do not share this medication with others.||
5051|173|N|   Certain foods, beverages, or food additives (such as red wine,||
5051|174|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
5051|175|N|patterns such as irregular eating/sleeping habits or stress may||
5051|176|N|bring on a migraine headache. Avoiding these "triggers" may help||
5051|177|N|lessen migraine attacks. Consult your doctor for more details.||
5051|178|N|   Lab and/or medical tests (such as blood pressure) may be done||
5051|179|N|while you are taking this medication. Keep all medical and lab||
5051|180|N|appointments. Consult your doctor for more details.||
5051|181|B|||
5051|182|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
5051|183|B|||
5051|184|R|STORAGE:  Store at room temperature away from light and moisture.||
5051|185|R|Do not store in the bathroom. Keep all medications away from||
5051|186|R|children and pets.||
5051|187|R|   Do not flush medications down the toilet or pour them into a||
5051|188|R|drain unless instructed to do so. Properly discard this product||
5051|189|R|when it is expired or no longer needed. Consult your pharmacist||
5051|190|R|or local waste disposal company.||
5051|191|B|||
5051|192|A|Information last revised May 2024.||
5051|193|A|Copyright(c) 2025 First Databank, Inc.||
5051|194|B|||
5052|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5052|002|Z|does NOT have all possible information about this product. This||
5052|003|Z|information does not assure that this product is safe, effective,||
5052|004|Z|or appropriate for you. This information is not individual||
5052|005|Z|medical advice and does not substitute for the advice of your||
5052|006|Z|health care professional. Always ask your health care||
5052|007|Z|professional for complete information about this product and your||
5052|008|Z|specific health needs.||
5052|009|B|||
5052|010|T|FLUCONAZOLE - ORAL||
5052|011|F|(floo-KON-a-zole)||
5052|012|B|||
5052|013|C|COMMON BRAND NAME(S): Diflucan||
5052|014|B|||
5052|015|U|USES:  Fluconazole is used to prevent and treat a variety of||
5052|016|U|fungal and yeast infections. It belongs to a class of drugs||
5052|017|U|called azole antifungals. It works by stopping the growth of||
5052|018|U|certain types of fungus.||
5052|019|B|||
5052|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5052|021|H|from your pharmacist before you start taking fluconazole and each||
5052|022|H|time you get a refill. If you have any questions, ask your doctor||
5052|023|H|or pharmacist.||
5052|024|H|   Take this medication by mouth with or without food as directed||
5052|025|H|by your doctor, usually once daily. The dosage is based on your||
5052|026|H|medical condition and response to treatment. Children's dosage is||
5052|027|H|also based on weight.||
5052|028|H|   If you are taking the liquid suspension form of this||
5052|029|H|medication, shake the bottle well before each dose. Carefully||
5052|030|H|measure the dose using a special measuring device/spoon. Do not||
5052|031|H|use a household spoon because you may not get the correct dose.||
5052|032|H|   This medication works best when the amount of medicine in your||
5052|033|H|body is kept at a constant level. Take it at the same time each||
5052|034|H|day as directed.||
5052|035|H|   Continue to take this medication until the full prescribed||
5052|036|H|amount is finished, even if symptoms disappear after a few days.||
5052|037|H|Stopping the medication too early may result in a return of the||
5052|038|H|infection.||
5052|039|H|   Tell your doctor if your condition lasts or gets worse.||
5052|040|B|||
5052|041|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach upset/pain,||
5052|042|S|headache, dizziness, or hair loss may occur. If any of these||
5052|043|S|effects last or get worse, tell your doctor or pharmacist||
5052|044|S|promptly.||
5052|045|S|   Remember that this medication has been prescribed because your||
5052|046|S|doctor has judged that the benefit to you is greater than the||
5052|047|S|risk of side effects. Many people using this medication do not||
5052|048|S|have serious side effects.||
5052|049|S|   Tell your doctor right away if you have any serious side||
5052|050|S|effects, including: signs of your adrenal glands not working well||
5052|051|S|(such as loss of appetite, unusual tiredness, weight loss).||
5052|052|S|   Get medical help right away if you have any very serious side||
5052|053|S|effects, including: fast/irregular heartbeat, severe dizziness,||
5052|054|S|fainting.||
5052|055|S|   This drug may rarely cause serious liver disease. Get medical||
5052|056|S|help right away if you develop any signs of liver disease,||
5052|057|S|including: nausea/vomiting that doesn't stop, severe||
5052|058|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
5052|059|S|   A very serious allergic reaction to this drug is rare.||
5052|060|S|However, get medical help right away if you notice any symptoms||
5052|061|S|of a serious allergic reaction, including: fever that doesn't go||
5052|062|S|away, new or worsening lymph node swelling, rash,||
5052|063|S|itching/swelling (especially of the face/tongue/throat), severe||
5052|064|S|dizziness, trouble breathing.||
5052|065|S|   This is not a complete list of possible side effects. If you||
5052|066|S|notice other effects not listed above, contact your doctor or||
5052|067|S|pharmacist.||
5052|068|S|   In the US -||
5052|069|S|   Call your doctor for medical advice about side effects. You||
5052|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5052|071|S|www.fda.gov/medwatch.||
5052|072|S|   In Canada - Call your doctor for medical advice about side||
5052|073|S|effects. You may report side effects to Health Canada at||
5052|074|S|1-866-234-2345.||
5052|075|B|||
5052|076|P|PRECAUTIONS:  Before taking fluconazole, tell your doctor or||
5052|077|P|pharmacist if you are allergic to it; or to other azole||
5052|078|P|antifungal drugs (such as ketoconazole, itraconazole); or if you||
5052|079|P|have any other allergies. This product may contain inactive||
5052|080|P|ingredients, which can cause allergic reactions or other||
5052|081|P|problems. Talk to your pharmacist for more details.||
5052|082|P|   Before using this medication, tell your doctor or pharmacist||
5052|083|P|your medical history, especially of: liver disease, kidney||
5052|084|P|disease.||
5052|085|P|   Fluconazole may cause a condition that affects the heart||
5052|086|P|rhythm (QT prolongation). QT prolongation can rarely cause||
5052|087|P|serious (rarely fatal) fast/irregular heartbeat and other||
5052|088|P|symptoms (such as severe dizziness, fainting) that need medical||
5052|089|P|attention right away.||
5052|090|P|   The risk of QT prolongation may be increased if you have||
5052|091|P|certain medical conditions or are taking other drugs that may||
5052|092|P|cause QT prolongation. Before using fluconazole, tell your doctor||
5052|093|P|or pharmacist of all the drugs you take and if you have any of||
5052|094|P|the following conditions: certain heart problems (heart failure,||
5052|095|P|slow heartbeat, QT prolongation in the EKG), family history of||
5052|096|P|certain heart problems (QT prolongation in the EKG, sudden||
5052|097|P|cardiac death).||
5052|098|P|   Low levels of potassium or magnesium in the blood may also||
5052|099|P|increase your risk of QT prolongation. This risk may increase if||
5052|100|P|you use certain drugs (such as diuretics/"water pills") or if you||
5052|101|P|have conditions such as severe sweating, diarrhea, or vomiting.||
5052|102|P|Talk to your doctor about using fluconazole safely.||
5052|103|P|   Although uncommon, this drug may make you dizzy. Alcohol or||
5052|104|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
5052|105|P|machinery, or do anything that needs alertness until you can do||
5052|106|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5052|107|P|are using marijuana (cannabis).||
5052|108|P|   Before having surgery, tell your doctor or dentist about all||
5052|109|P|the products you use (including prescription drugs,||
5052|110|P|nonprescription drugs, and herbal products).||
5052|111|P|   Older adults may be more sensitive to the side effects of this||
5052|112|P|drug, especially rash, vomiting, diarrhea, and QT prolongation||
5052|113|P|(see above).||
5052|114|P|   Tell your doctor if you are pregnant or plan to become||
5052|115|P|pregnant. You should not become pregnant while using fluconazole.||
5052|116|P|Fluconazole may harm an unborn baby, especially during the first||
5052|117|P|3 months of pregnancy. Ask about reliable forms of birth control||
5052|118|P|while using this medication and for 1 week after the last dose.||
5052|119|P|For the treatment of vaginal yeast infections, medications||
5052|120|P|applied in or around the vagina should be considered before this||
5052|121|P|medication. If you become pregnant, talk to your doctor right||
5052|122|P|away about the risks and benefits of this medication.||
5052|123|P|   Fluconazole passes into breast milk but is unlikely to harm a||
5052|124|P|nursing infant. Consult your doctor before breastfeeding.||
5052|125|B|||
5052|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5052|127|I|medications work or increase your risk for serious side effects.||
5052|128|I|This document does not contain all possible drug interactions.||
5052|129|I|Keep a list of all the products you use (including||
5052|130|I|prescription/nonprescription drugs and herbal products) and share||
5052|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
5052|132|I|the dosage of any medicines without your doctor's approval.||
5052|133|I|   Products that may interact with this drug include:||
5052|134|I|clopidogrel.||
5052|135|I|   Many drugs besides fluconazole may affect the heart rhythm (QT||
5052|136|I|prolongation), including pimozide, quinidine, macrolide||
5052|137|I|antibiotics (such as erythromycin), among others.||
5052|138|I|   Fluconazole can slow down the removal of other medications||
5052|139|I|from your body, which can affect how they work. Examples of||
5052|140|I|affected drugs include abrocitinib, deuruxolitinib, domperidone,||
5052|141|I|flibanserin, lemborexant, lomitapide, macitentan, mavacamten,||
5052|142|I|nirogacestat, rilzabrutinib, taletrectinib, among others.||
5052|143|B|||
5052|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5052|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5052|146|O|poison control center right away. US residents can call||
5052|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5052|148|O|Symptoms of overdose may include: hallucinations, mental/mood||
5052|149|O|changes.||
5052|150|B|||
5052|151|N|NOTES:  Do not share this medication with others.||
5052|152|N|   This medication has been prescribed for your current condition||
5052|153|N|only. Do not use it later for another infection unless your||
5052|154|N|doctor tells you to.||
5052|155|N|   Lab and/or medical tests (such as liver function) should be||
5052|156|N|done while you are taking this medication. Keep all medical and||
5052|157|N|lab appointments. Consult your doctor for more details.||
5052|158|B|||
5052|159|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5052|160|D|remember. If it is near the time of the next dose, skip the||
5052|161|D|missed dose. Take your next dose at the regular time. Do not||
5052|162|D|double the dose to catch up.||
5052|163|B|||
5052|164|R|STORAGE:  Store the tablets at room temperature away from light||
5052|165|R|and moisture. Do not store in the bathroom. Store the liquid||
5052|166|R|suspension at room temperature or in the refrigerator. Do not||
5052|167|R|freeze. Discard any unused suspension after 14 days. Keep all||
5052|168|R|medications away from children and pets.||
5052|169|R|   Do not flush medications down the toilet or pour them into a||
5052|170|R|drain unless instructed to do so. Properly discard this product||
5052|171|R|when it is expired or no longer needed. Consult your pharmacist||
5052|172|R|or local waste disposal company.||
5052|173|B|||
5052|174|A|Information last revised September 2025.||
5052|175|A|Copyright(c) 2025 First Databank, Inc.||
5052|176|B|||
5053|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5053|002|Z|does NOT have all possible information about this product. This||
5053|003|Z|information does not assure that this product is safe, effective,||
5053|004|Z|or appropriate for you. This information is not individual||
5053|005|Z|medical advice and does not substitute for the advice of your||
5053|006|Z|health care professional. Always ask your health care||
5053|007|Z|professional for complete information about this product and your||
5053|008|Z|specific health needs.||
5053|009|B|||
5053|010|T|PROCHLORPERAZINE - RECTAL||
5053|011|F|(PROE-klor-PER-a-zeen)||
5053|012|B|||
5053|013|C|COMMON BRAND NAME(S): Compazine||
5053|014|B|||
5053|015|W|WARNING:  There may be a slightly increased risk of serious,||
5053|016|W|possibly fatal side effects (such as heart failure,||
5053|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
5053|018|W|by older adults with dementia. This medication is not approved||
5053|019|W|for the treatment of dementia-related behavior problems. Discuss||
5053|020|W|the risks and benefits of this medication with the doctor.||
5053|021|B|||
5053|022|U|USES:  This medication is used to treat severe nausea and||
5053|023|U|vomiting from certain causes (for example, after surgery or||
5053|024|U|cancer treatment). Prochlorperazine belongs to a class of drugs||
5053|025|U|known as phenothiazines.||
5053|026|U|   This medication is not recommended for use in children younger||
5053|027|U|than 2 years or in children going through surgery.||
5053|028|B|||
5053|029|H|HOW TO USE:  Unwrap and insert one suppository rectally as||
5053|030|H|directed by your doctor, usually 2 times a day. Remain lying down||
5053|031|H|for a few minutes after using this medication, and avoid having a||
5053|032|H|bowel movement for an hour or longer so the drug will be||
5053|033|H|absorbed. The suppository is for rectal use only.||
5053|034|H|   The dosage is based on your age, medical condition, and||
5053|035|H|response to treatment. Children's dosage may also be based on||
5053|036|H|weight. Do not increase your dose or use this medication more||
5053|037|H|often than directed.||
5053|038|H|   Tell your doctor if your condition lasts or gets worse.||
5053|039|B|||
5053|040|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, blurred||
5053|041|S|vision, constipation, or dry mouth may occur. If any of these||
5053|042|S|effects last or get worse, tell your doctor or pharmacist||
5053|043|S|promptly.||
5053|044|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
5053|045|S|chips, chew (sugarless) gum, drink water, or use a saliva||
5053|046|S|substitute.||
5053|047|S|   To reduce the risk of dizziness and lightheadedness, get up||
5053|048|S|slowly when rising from a sitting or lying position.||
5053|049|S|   Remember that this medication has been prescribed because your||
5053|050|S|doctor has judged that the benefit to you is greater than the||
5053|051|S|risk of side effects. Many people using this medication do not||
5053|052|S|have serious side effects.||
5053|053|S|   Tell your doctor right away if you have any serious side||
5053|054|S|effects, including: nausea/vomiting that doesn't stop,||
5053|055|S|mental/mood changes (such as agitation, restlessness),||
5053|056|S|unusual/uncontrolled movements (such as fixed upward stare, neck||
5053|057|S|twisting, tongue movements, muscle spasms), shaking (tremor),||
5053|058|S|difficulty urinating, enlarged/tender breasts, unusual breast||
5053|059|S|milk production, weakness, easy bleeding/bruising, signs of||
5053|060|S|infection (such as sore throat that doesn't go away, fever,||
5053|061|S|chills), severe stomach/abdominal pain, yellowing eyes/skin.||
5053|062|S|   Get medical help right away if you have any very serious side||
5053|063|S|effects, including: seizures.||
5053|064|S|   This medication may rarely cause a very serious condition||
5053|065|S|called neuroleptic malignant syndrome (NMS). Get medical help||
5053|066|S|right away if you have any of the following symptoms: fever,||
5053|067|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
5053|068|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
5053|069|S|signs of kidney problems (such as change in the amount of urine).||
5053|070|S|   A very serious allergic reaction to this drug is rare.||
5053|071|S|However, get medical help right away if you notice any symptoms||
5053|072|S|of a serious allergic reaction, including: rash, itching/swelling||
5053|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5053|074|S|breathing.||
5053|075|S|   This is not a complete list of possible side effects. If you||
5053|076|S|notice other effects not listed above, contact your doctor or||
5053|077|S|pharmacist.||
5053|078|S|   In the US -||
5053|079|S|   Call your doctor for medical advice about side effects. You||
5053|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5053|081|S|www.fda.gov/medwatch.||
5053|082|S|   In Canada - Call your doctor for medical advice about side||
5053|083|S|effects. You may report side effects to Health Canada at||
5053|084|S|1-866-234-2345.||
5053|085|B|||
5053|086|P|PRECAUTIONS:  Before using prochlorperazine, tell your doctor or||
5053|087|P|pharmacist if you are allergic to it; or to other phenothiazines||
5053|088|P|(such as chlorpromazine); or if you have any other allergies.||
5053|089|P|This product may contain inactive ingredients, which can cause||
5053|090|P|allergic reactions or other problems. Talk to your pharmacist for||
5053|091|P|more details.||
5053|092|P|   Before using this medication, tell your doctor or pharmacist||
5053|093|P|your medical history, especially of: breathing problems (such as||
5053|094|P|asthma, chronic obstructive pulmonary disease-COPD), blood/immune||
5053|095|P|system disorders (such as bone marrow depression), high pressure||
5053|096|P|in the eye (glaucoma), heart disease (such as irregular||
5053|097|P|heartbeat), liver disease, kidney disease, certain brain||
5053|098|P|disorders (such as Reye's syndrome, seizures), stomach/intestine||
5053|099|P|problems (such as blockage), difficulty urinating (for example,||
5053|100|P|due to enlarged prostate), a certain adrenal gland tumor||
5053|101|P|(pheochromocytoma).||
5053|102|P|   This drug may make you dizzy or drowsy or blur your vision.||
5053|103|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
5053|104|P|drowsy. Do not drive, use machinery, or do anything that needs||
5053|105|P|alertness or clear vision until you can do it safely. Avoid||
5053|106|P|alcoholic beverages. Talk to your doctor if you are using||
5053|107|P|marijuana (cannabis).||
5053|108|P|   Before having surgery, tell your doctor or dentist about all||
5053|109|P|the products you use (including prescription drugs,||
5053|110|P|nonprescription drugs, and herbal products).||
5053|111|P|   This medication may make you more sensitive to the sun. Limit||
5053|112|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5053|113|P|sunscreen and wear protective clothing when outdoors. Tell your||
5053|114|P|doctor right away if you get sunburned or have skin||
5053|115|P|blisters/redness.||
5053|116|P|   This medication may make you sweat less, making you more||
5053|117|P|likely to get heat stroke. Avoid doing things that may cause you||
5053|118|P|to overheat, such as hard work or exercise in hot weather, or||
5053|119|P|using hot tubs. When the weather is hot, drink a lot of fluids||
5053|120|P|and dress lightly. If you overheat, quickly look for a place to||
5053|121|P|cool down and rest. Get medical help right away if you have a||
5053|122|P|fever that does not go away, mental/mood changes, headache, or||
5053|123|P|dizziness.||
5053|124|P|   Children may be more sensitive to the side effects of this||
5053|125|P|drug, especially uncontrolled movements. They may be at greater||
5053|126|P|risk when they are sick (such as having viral infection,||
5053|127|P|dehydration).||
5053|128|P|   Older adults may be more sensitive to the side effects of this||
5053|129|P|drug, especially low blood pressure, constipation, urinary||
5053|130|P|problems, and nerve/muscle problems.||
5053|131|P|   During pregnancy, this medication should be used only when||
5053|132|P|clearly needed. Discuss the risks and benefits with your doctor.||
5053|133|P|Babies born to mothers who have used this drug during the last 3||
5053|134|P|months of pregnancy may rarely develop symptoms including muscle||
5053|135|P|stiffness or shakiness, drowsiness, feeding/breathing||
5053|136|P|difficulties, or constant crying. If you notice any of these||
5053|137|P|symptoms in your newborn anytime during their first month, tell||
5053|138|P|the doctor right away.||
5053|139|P|   It is unknown if prochlorperazine passes into breast milk.||
5053|140|P|However, similar drugs pass into breast milk. Consult your doctor||
5053|141|P|before breastfeeding.||
5053|142|B|||
5053|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5053|144|I|medications work or increase your risk for serious side effects.||
5053|145|I|This document does not contain all possible drug interactions.||
5053|146|I|Keep a list of all the products you use (including||
5053|147|I|prescription/nonprescription drugs and herbal products) and share||
5053|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
5053|149|I|the dosage of any medicines without your doctor's approval.||
5053|150|I|   Some products that may interact with this drug include:||
5053|151|I|cabergoline, dofetilide, metoclopramide.||
5053|152|I|   Tell your doctor or pharmacist if you are taking other||
5053|153|I|products that cause drowsiness such as opioid pain or cough||
5053|154|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5053|155|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5053|156|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5053|157|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5053|158|I|diphenhydramine).||
5053|159|I|   Check the labels on all your medicines (such as allergy or||
5053|160|I|cough-and-cold products) because they may contain ingredients||
5053|161|I|that cause drowsiness. Ask your pharmacist about using those||
5053|162|I|products safely.||
5053|163|I|   This medication may interfere with certain lab tests (such as||
5053|164|I|phenylketonuria, certain pregnancy tests), possibly causing false||
5053|165|I|test results. Make sure lab personnel and all your doctors know||
5053|166|I|you use this drug.||
5053|167|B|||
5053|168|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5053|169|O|has overdosed and has serious symptoms such as passing out or||
5053|170|O|trouble breathing, call 911. Otherwise, call a poison control||
5053|171|O|center right away. US residents can call 1-800-222-1222. Canada||
5053|172|O|residents can call 1-844-764-7669. Symptoms of overdose may||
5053|173|O|include: mental/mood changes (such as restlessness, agitation),||
5053|174|O|severe drowsiness, seizures, irregular heartbeat.||
5053|175|B|||
5053|176|N|NOTES:  Do not share this medication with others.||
5053|177|N|   Lab and/or medical tests may be done while you are using this||
5053|178|N|medication. Keep all medical and lab appointments. Consult your||
5053|179|N|doctor for more details.||
5053|180|B|||
5053|181|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5053|182|D|If it is near the time of the next dose, skip the missed dose.||
5053|183|D|Use your next dose at the regular time. Do not double the dose to||
5053|184|D|catch up.||
5053|185|B|||
5053|186|R|STORAGE:  Store at room temperature away from light. Keep all||
5053|187|R|medications away from children and pets.||
5053|188|R|   Do not flush medications down the toilet or pour them into a||
5053|189|R|drain unless instructed to do so. Properly discard this product||
5053|190|R|when it is expired or no longer needed. Consult your pharmacist||
5053|191|R|or local waste disposal company.||
5053|192|B|||
5053|193|A|Information last revised May 2025.||
5053|194|A|Copyright(c) 2025 First Databank, Inc.||
5053|195|B|||
5060|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5060|002|Z|does NOT have all possible information about this product. This||
5060|003|Z|information does not assure that this product is safe, effective,||
5060|004|Z|or appropriate for you. This information is not individual||
5060|005|Z|medical advice and does not substitute for the advice of your||
5060|006|Z|health care professional. Always ask your health care||
5060|007|Z|professional for complete information about this product and your||
5060|008|Z|specific health needs.||
5060|009|B|||
5060|010|T|TERAZOSIN - ORAL||
5060|011|F|(ter-AY-zoe-sin)||
5060|012|B|||
5060|013|C|COMMON BRAND NAME(S): Hytrin, Tezruly||
5060|014|B|||
5060|015|U|USES:  Terazosin is used alone or with other drugs to treat high||
5060|016|U|blood pressure (hypertension). Lowering high blood pressure helps||
5060|017|U|prevent strokes, heart attacks, and kidney problems. This||
5060|018|U|medication works by relaxing blood vessels so blood can flow more||
5060|019|U|easily.||
5060|020|U|   Terazosin is also used in men to treat the symptoms of an||
5060|021|U|enlarged prostate (benign prostatic hyperplasia-BPH). It does not||
5060|022|U|shrink the prostate, but it works by relaxing the muscles in the||
5060|023|U|prostate and part of the bladder. This helps to relieve symptoms||
5060|024|U|of BPH such as difficulty in beginning the flow of urine, weak||
5060|025|U|stream, and the need to urinate often or urgently (including||
5060|026|U|during the middle of the night).||
5060|027|U|   Terazosin belongs to a class of drugs known as alpha blockers.||
5060|028|B|||
5060|029|V|OTHER USES:  This section contains uses of this drug that are not||
5060|030|V|listed in the approved professional labeling for the drug but||
5060|031|V|that may be prescribed by your health care professional. Use this||
5060|032|V|drug for a condition that is listed in this section only if it||
5060|033|V|has been so prescribed by your health care professional.||
5060|034|V|   This drug may also be used to help your body "pass," or get||
5060|035|V|rid of, kidney stones through urination. It may also be used for||
5060|036|V|bladder problems in women.||
5060|037|B|||
5060|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5060|039|H|from your pharmacist before you start taking terazosin and each||
5060|040|H|time you get a refill. If you have any questions, ask your doctor||
5060|041|H|or pharmacist.||
5060|042|H|   Take this medication by mouth with or without food as directed||
5060|043|H|by your doctor, usually once daily at bedtime.||
5060|044|H|   If you are using the liquid form of this medication, carefully||
5060|045|H|measure the dose using a special measuring device/spoon. Do not||
5060|046|H|use a household spoon because you may not get the correct dose.||
5060|047|H|   If you are taking this drug for the first time, do not take||
5060|048|H|more than 1 milligram to start. Terazosin may cause a sudden drop||
5060|049|H|in your blood pressure, which could lead to dizziness or||
5060|050|H|fainting. This risk is higher when taking your first dose. To||
5060|051|H|avoid injury related to dizziness or fainting, take your first||
5060|052|H|dose of terazosin at bedtime.||
5060|053|H|   Your doctor will start this medication at a low dose and||
5060|054|H|gradually increase your dose. Any time your dose is increased or||
5060|055|H|if you restart treatment after you have stopped it, take your||
5060|056|H|first dose at bedtime unless otherwise directed to lessen the||
5060|057|H|risk of injury related to dizziness or fainting. Also during||
5060|058|H|these times, avoid situations where you may be injured if you||
5060|059|H|faint.||
5060|060|H|   The dosage is based on your medical condition and response to||
5060|061|H|treatment.||
5060|062|H|   Take this medication regularly to get the most benefit from||
5060|063|H|it. To help you remember, take it at the same time each day. If||
5060|064|H|you miss taking terazosin for a few days, you may need to restart||
5060|065|H|treatment at the low dose and gradually increase your dose again.||
5060|066|H|Consult your doctor for more details.||
5060|067|H|   If you are taking this medication for high blood pressure,||
5060|068|H|keep taking this medication even if you feel well. Most people||
5060|069|H|with high blood pressure do not feel sick.||
5060|070|H|   If you are taking this drug for an enlarged prostate, it may||
5060|071|H|take 2 to 4 weeks to see an improvement in your symptoms, and up||
5060|072|H|to 6 weeks before you see the full benefit of this drug.||
5060|073|H|   Tell your doctor if your condition does not get better or if||
5060|074|H|it gets worse (for example, your blood pressure readings remain||
5060|075|H|high or increase).||
5060|076|B|||
5060|077|S|SIDE EFFECTS:  Dizziness, lightheadedness, tiredness, nausea,||
5060|078|S|drowsiness, blurred vision, headache, or stuffy nose may occur.||
5060|079|S|If any of these effects last or get worse, tell your doctor or||
5060|080|S|pharmacist promptly.||
5060|081|S|   To reduce the risk of dizziness and lightheadedness, get up||
5060|082|S|slowly when rising from a sitting or lying position.||
5060|083|S|   Remember that this medication has been prescribed because your||
5060|084|S|doctor has judged that the benefit to you is greater than the||
5060|085|S|risk of side effects. Many people using this medication do not||
5060|086|S|have serious side effects.||
5060|087|S|   Tell your doctor right away if you have any serious side||
5060|088|S|effects, including: fainting, fast/irregular heartbeat,||
5060|089|S|burning/tingling in the hands/feet, sexual function problems,||
5060|090|S|swelling of the ankles/hands/feet, unexpected weight gain.||
5060|091|S|   Rarely, males may have a painful or prolonged erection lasting||
5060|092|S|4 or more hours. If this occurs, stop using this drug and get||
5060|093|S|medical help right away, or permanent problems could occur.||
5060|094|S|   A very serious allergic reaction to this drug is rare.||
5060|095|S|However, get medical help right away if you notice any symptoms||
5060|096|S|of a serious allergic reaction, including: rash, itching/swelling||
5060|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5060|098|S|breathing.||
5060|099|S|   This is not a complete list of possible side effects. If you||
5060|100|S|notice other effects not listed above, contact your doctor or||
5060|101|S|pharmacist.||
5060|102|S|   In the US -||
5060|103|S|   Call your doctor for medical advice about side effects. You||
5060|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5060|105|S|www.fda.gov/medwatch.||
5060|106|S|   In Canada - Call your doctor for medical advice about side||
5060|107|S|effects. You may report side effects to Health Canada at||
5060|108|S|1-866-234-2345.||
5060|109|B|||
5060|110|P|PRECAUTIONS:  Before taking terazosin, tell your doctor or||
5060|111|P|pharmacist if you are allergic to it; or to other alpha blockers||
5060|112|P|such as doxazosin or prazosin; or if you have any other||
5060|113|P|allergies. This product may contain inactive ingredients, which||
5060|114|P|can cause allergic reactions or other problems. Talk to your||
5060|115|P|pharmacist for more details.||
5060|116|P|   Before using this medication, tell your doctor or pharmacist||
5060|117|P|your medical history, especially of: low blood pressure/fainting,||
5060|118|P|certain eye problems (cataracts, glaucoma).||
5060|119|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5060|120|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5060|121|P|machinery, or do anything that needs alertness until you can do||
5060|122|P|it safely. You should avoid driving or hazardous tasks for 12||
5060|123|P|hours after the first dose, after your dose is increased, and||
5060|124|P|when this medication is restarted after it has been stopped.||
5060|125|P|Limit alcoholic beverages. Talk to your doctor if you are using||
5060|126|P|marijuana (cannabis).||
5060|127|P|   Before having surgery (including cataract/glaucoma eye||
5060|128|P|surgery), tell your doctor or dentist if you are taking or have||
5060|129|P|ever taken this medication, and about all the other products you||
5060|130|P|use (including prescription drugs, nonprescription drugs, and||
5060|131|P|herbal products).||
5060|132|P|   Older adults may be more sensitive to the side effects of this||
5060|133|P|drug, especially dizziness, fainting, and low blood pressure when||
5060|134|P|getting up from a sitting or lying position. These side effects||
5060|135|P|can increase the risk of falling.||
5060|136|P|   During pregnancy, this medication should be used only when||
5060|137|P|clearly needed. Discuss the risks and benefits with your doctor.||
5060|138|P|   It is unknown if this drug passes into breast milk. Consult||
5060|139|P|your doctor before breastfeeding.||
5060|140|B|||
5060|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5060|142|I|medications work or increase your risk for serious side effects.||
5060|143|I|This document does not contain all possible drug interactions.||
5060|144|I|Keep a list of all the products you use (including||
5060|145|I|prescription/nonprescription drugs and herbal products) and share||
5060|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
5060|147|I|the dosage of any medicines without your doctor's approval.||
5060|148|I|   Some products that may interact with this drug include: other||
5060|149|I|alpha blocker drugs (such as prazosin, tamsulosin).||
5060|150|I|   If you are also taking a drug to treat erectile dysfunction-ED||
5060|151|I|or pulmonary hypertension (such as sildenafil, tadalafil), your||
5060|152|I|blood pressure may get too low which can lead to dizziness or||
5060|153|I|fainting. Your doctor may need to adjust your medications to||
5060|154|I|minimize this risk.||
5060|155|I|   Some products have ingredients that could raise your blood||
5060|156|I|pressure. Tell your pharmacist what products you are using, and||
5060|157|I|ask how to use them safely (especially cough-and-cold products,||
5060|158|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
5060|159|B|||
5060|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5060|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5060|162|O|poison control center right away. US residents can call||
5060|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5060|164|O|Symptoms of overdose may include: severe dizziness, fainting.||
5060|165|B|||
5060|166|N|NOTES:  Do not share this medication with others.||
5060|167|N|   If you have high blood pressure, lifestyle changes that may||
5060|168|N|help this medication work better include exercising, stopping||
5060|169|N|smoking, and eating a low-cholesterol/low-fat diet. Consult your||
5060|170|N|doctor for more details.||
5060|171|N|   Have your blood pressure checked regularly while taking this||
5060|172|N|medication. Learn how to monitor your own blood pressure at home,||
5060|173|N|and share the results with your doctor.||
5060|174|N|   Lab and/or medical tests (such as prostate exams, blood||
5060|175|N|pressure) should be done while you are taking this medication.||
5060|176|N|Keep all medical and lab appointments. Consult your doctor for||
5060|177|N|more details.||
5060|178|B|||
5060|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5060|180|D|remember. If it is near the time of the next dose, skip the||
5060|181|D|missed dose. Take your next dose at the regular time. Do not||
5060|182|D|double the dose to catch up. See also How to Use section.||
5060|183|B|||
5060|184|R|STORAGE:  Store at room temperature away from light and moisture.||
5060|185|R|Do not store in the bathroom. Keep all medications away from||
5060|186|R|children and pets.||
5060|187|R|   Do not flush medications down the toilet or pour them into a||
5060|188|R|drain unless instructed to do so. Properly discard this product||
5060|189|R|when it is expired or no longer needed. Consult your pharmacist||
5060|190|R|or local waste disposal company.||
5060|191|B|||
5060|192|A|Information last revised April 2025.||
5060|193|A|Copyright(c) 2025 First Databank, Inc.||
5060|194|B|||
5061|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5061|002|Z|does NOT have all possible information about this product. This||
5061|003|Z|information does not assure that this product is safe, effective,||
5061|004|Z|or appropriate for you. This information is not individual||
5061|005|Z|medical advice and does not substitute for the advice of your||
5061|006|Z|health care professional. Always ask your health care||
5061|007|Z|professional for complete information about this product and your||
5061|008|Z|specific health needs.||
5061|009|B|||
5061|010|T|ACARBOSE - ORAL||
5061|011|F|(AY-kar-bose)||
5061|012|B|||
5061|013|C|COMMON BRAND NAME(S): Precose||
5061|014|B|||
5061|015|U|USES:  Acarbose is used with a proper diet and exercise program||
5061|016|U|to control high blood sugar in people with type 2 diabetes.||
5061|017|U|Controlling high blood sugar helps prevent kidney damage,||
5061|018|U|blindness, nerve problems, loss of limbs, and sexual function||
5061|019|U|problems. Proper control of diabetes may also lessen your risk of||
5061|020|U|a heart attack or stroke. Acarbose works in your intestines to||
5061|021|U|slow the breakdown and absorption of carbohydrates from foods||
5061|022|U|that you eat. This effect helps lessen your blood sugar rise||
5061|023|U|after a meal.||
5061|024|B|||
5061|025|H|HOW TO USE:  Take this medication by mouth as directed by your||
5061|026|H|doctor, usually 3 times daily with the first bite of a meal. The||
5061|027|H|dosage is based on your medical condition and response to||
5061|028|H|treatment. To reduce your risk of side effects, your doctor may||
5061|029|H|direct you to start this medication at a low dose and gradually||
5061|030|H|increase your dose. Follow your doctor's instructions carefully.||
5061|031|H|   Use this medication regularly to get the most benefit from it.||
5061|032|H|To help you remember, take it at the same times each day.||
5061|033|H|   Tell your doctor if your condition does not get better or if||
5061|034|H|it gets worse (your blood sugar is too high or too low).||
5061|035|B|||
5061|036|S|SIDE EFFECTS:  Diarrhea, gas, or abdominal discomfort/pain may||
5061|037|S|occur as your body adjusts to this medication during the first||
5061|038|S|few weeks. These side effects usually lessen with time. If any of||
5061|039|S|these effects last or get worse, tell your doctor or pharmacist||
5061|040|S|promptly.||
5061|041|S|   Remember that this medication has been prescribed because your||
5061|042|S|doctor has judged that the benefit to you is greater than the||
5061|043|S|risk of side effects. Many people using this medication do not||
5061|044|S|have serious side effects.||
5061|045|S|   Tell your doctor right away if you have any serious side||
5061|046|S|effects, including: signs of liver problems (such as||
5061|047|S|nausea/vomiting that doesn't stop, loss of appetite,||
5061|048|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
5061|049|S|   Acarbose does not usually cause low blood sugar||
5061|050|S|(hypoglycemia). Low blood sugar may occur if this drug is||
5061|051|S|prescribed with other diabetes medications, or if you do not get||
5061|052|S|enough calories from food, or if you do unusually heavy exercise.||
5061|053|S|Talk with your doctor or pharmacist about whether the dose of||
5061|054|S|your other diabetes medication(s) needs to be lowered. Symptoms||
5061|055|S|of low blood sugar include sudden sweating, shaking, fast||
5061|056|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
5061|057|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
5061|058|S|treat low blood sugar. If you don't have these reliable forms of||
5061|059|S|glucose, rapidly raise your blood sugar by eating some honey or||
5061|060|S|drinking a glass of orange juice. Do not use table sugar or drink||
5061|061|S|non-diet soda to relieve these symptoms because acarbose slows||
5061|062|S|the breakdown of table sugar. Tell your doctor right away about||
5061|063|S|the reaction and the use of this product. To help prevent low||
5061|064|S|blood sugar, eat meals on a regular schedule and do not skip||
5061|065|S|meals. Check with your doctor or pharmacist to find out what you||
5061|066|S|should do if you miss a meal.||
5061|067|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
5061|068|S|thirst/urination. If these symptoms occur, tell your doctor right||
5061|069|S|away. Your doctor may need to adjust your diabetes medication,||
5061|070|S|exercise program, or diet.||
5061|071|S|   This medication may rarely cause a serious intestinal||
5061|072|S|condition (pneumatosis cystoides intestinalis). Tell your doctor||
5061|073|S|right away if you develop: diarrhea that doesn't stop,||
5061|074|S|constipation, blood/mucus in stool.||
5061|075|S|   A very serious allergic reaction to this drug is rare.||
5061|076|S|However, get medical help right away if you notice any symptoms||
5061|077|S|of a serious allergic reaction, including: rash, itching/swelling||
5061|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5061|079|S|breathing.||
5061|080|S|   This is not a complete list of possible side effects. If you||
5061|081|S|notice other effects not listed above, contact your doctor or||
5061|082|S|pharmacist.||
5061|083|S|   In the US -||
5061|084|S|   Call your doctor for medical advice about side effects. You||
5061|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5061|086|S|www.fda.gov/medwatch.||
5061|087|S|   In Canada - Call your doctor for medical advice about side||
5061|088|S|effects. You may report side effects to Health Canada at||
5061|089|S|1-866-234-2345.||
5061|090|B|||
5061|091|P|PRECAUTIONS:  Before taking acarbose, tell your doctor or||
5061|092|P|pharmacist if you are allergic to it; or if you have any other||
5061|093|P|allergies. This product may contain inactive ingredients, which||
5061|094|P|can cause allergic reactions or other problems. Talk to your||
5061|095|P|pharmacist for more details.||
5061|096|P|   Before using this medication, tell your doctor or pharmacist||
5061|097|P|your medical history, especially of: intestine/bowel problems||
5061|098|P|(such as inflammatory bowel disease, blockage, ulcers), kidney||
5061|099|P|problems, liver disease.||
5061|100|P|   You may experience blurred vision, dizziness, or drowsiness||
5061|101|P|due to extremely low or high blood sugar. Do not drive, use||
5061|102|P|machinery, or do anything that needs alertness or clear vision||
5061|103|P|until you can do it safely.||
5061|104|P|   Limit alcohol while taking this medication because it can||
5061|105|P|increase your risk of developing low blood sugar.||
5061|106|P|   It may be harder to control your blood sugar when your body is||
5061|107|P|stressed (such as due to fever, infection, injury, or surgery).||
5061|108|P|Consult your doctor because this may require a change in your||
5061|109|P|treatment plan, medications, or blood sugar testing.||
5061|110|P|   Before having surgery, tell your doctor or dentist about all||
5061|111|P|the products you use (including prescription drugs,||
5061|112|P|nonprescription drugs, and herbal products).||
5061|113|P|   During pregnancy, this medication should be used only when||
5061|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
5061|115|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
5061|116|P|your doctor for managing your blood sugar while pregnant. Your||
5061|117|P|doctor may change your diabetes treatment during your pregnancy||
5061|118|P|(such as diet and medications including insulin).||
5061|119|P|   It is unknown if this medication passes into breast milk.||
5061|120|P|Consult your doctor before breastfeeding.||
5061|121|B|||
5061|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5061|123|I|medications work or increase your risk for serious side effects.||
5061|124|I|This document does not contain all possible drug interactions.||
5061|125|I|Keep a list of all the products you use (including||
5061|126|I|prescription/nonprescription drugs and herbal products) and share||
5061|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
5061|128|I|the dosage of any medicines without your doctor's approval.||
5061|129|I|   Some products that may interact with this drug are: charcoal||
5061|130|I|products taken by mouth, digestive enzyme products (such as||
5061|131|I|amylase, pancreatin), pramlintide.||
5061|132|I|   Beta blocker medications (such as metoprolol, propranolol,||
5061|133|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
5061|134|I|heartbeat you would usually feel when your blood sugar falls too||
5061|135|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
5061|136|I|dizziness, hunger, or sweating, are not affected by these drugs.||
5061|137|I|   Many drugs can affect your blood sugar, making it harder to||
5061|138|I|control. Before you start, stop, or change any medication, talk||
5061|139|I|with your doctor or pharmacist about how the medication may||
5061|140|I|affect your blood sugar. Check your blood sugar regularly as||
5061|141|I|directed and share the results with your doctor. Tell your doctor||
5061|142|I|right away if you have symptoms of high or low blood sugar. (See||
5061|143|I|also Side Effects section.) Your doctor may need to adjust your||
5061|144|I|diabetes medication, exercise program, or diet.||
5061|145|B|||
5061|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5061|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5061|148|O|poison control center right away. US residents can call||
5061|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5061|150|B|||
5061|151|N|NOTES:  Do not share this medication with others.||
5061|152|N|   Attend a diabetes education program to learn more about how to||
5061|153|N|manage your diabetes with medications, diet, exercise, and||
5061|154|N|regular medical exams.||
5061|155|N|   Learn the symptoms of high and low blood sugar and how to||
5061|156|N|treat low blood sugar. Check your blood sugar regularly as||
5061|157|N|directed.||
5061|158|N|   Lab and/or medical tests (such as kidney/liver function,||
5061|159|N|hemoglobin A1c) should be done while you are taking this||
5061|160|N|medication. Keep all medical and lab appointments.||
5061|161|B|||
5061|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5061|163|D|remember. If it is near the time of the next dose, skip the||
5061|164|D|missed dose. Take your next dose at the regular time. Do not||
5061|165|D|double the dose to catch up.||
5061|166|B|||
5061|167|R|STORAGE:  Store at room temperature away from light and moisture.||
5061|168|R|Do not store in the bathroom. Keep all medications away from||
5061|169|R|children and pets.||
5061|170|R|   Do not flush medications down the toilet or pour them into a||
5061|171|R|drain unless instructed to do so. Properly discard this product||
5061|172|R|when it is expired or no longer needed. Consult your pharmacist||
5061|173|R|or local waste disposal company.||
5061|174|B|||
5061|175|M|MEDICAL ALERT:  Your condition can cause complications in a||
5061|176|M|medical emergency. For information about enrolling in MedicAlert,||
5061|177|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5061|178|B|||
5061|179|A|Information last revised May 2025.||
5061|180|A|Copyright(c) 2025 First Databank, Inc.||
5061|181|B|||
5063|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5063|002|Z|does NOT have all possible information about this product. This||
5063|003|Z|information does not assure that this product is safe, effective,||
5063|004|Z|or appropriate for you. This information is not individual||
5063|005|Z|medical advice and does not substitute for the advice of your||
5063|006|Z|health care professional. Always ask your health care||
5063|007|Z|professional for complete information about this product and your||
5063|008|Z|specific health needs.||
5063|009|B|||
5063|010|T|PYRETHRINS AND PIPERONYL BUTOXIDE SHAMPOO - TOPICAL||
5063|011|F|(pie-RETH-rins and pip-ER-oh-nill byoo-TOX-ide)||
5063|012|B|||
5063|013|C|COMMON BRAND NAME(S): Medi-Lice, R & C||
5063|014|B|||
5063|015|U|USES:  This medication is used to treat lice, which are tiny||
5063|016|U|insects that can infest and irritate the scalp (head lice), the||
5063|017|U|pubic area (crabs), or the body. This medication works by||
5063|018|U|paralyzing and killing lice.||
5063|019|B|||
5063|020|H|HOW TO USE:  Review the manufacturer's instruction sheet and||
5063|021|H|carefully follow all directions for your product. If any of this||
5063|022|H|information is unclear, talk to your doctor or pharmacist. Do not||
5063|023|H|use more drug than recommended.||
5063|024|H|   This medication is for use on the outside of the body only.||
5063|025|H|Avoid applying this drug to the eyes, nose, mouth, or vagina. If||
5063|026|H|this product gets in these areas, rinse with plenty of water. If||
5063|027|H|irritation occurs, tell your doctor promptly.||
5063|028|H|   Do not use this product on eyelashes or eyebrows. Check with||
5063|029|H|your doctor if these areas have lice.||
5063|030|H|   If applying this product to an infant, cover the infant's||
5063|031|H|hands and feet after applying the drug to make sure this product||
5063|032|H|does not get in the infant's mouth.||
5063|033|H|   Apply this drug in an area with good air flow (such as near an||
5063|034|H|open window).||
5063|035|H|   Apply this drug to the hair and scalp once, thoroughly||
5063|036|H|covering the affected area. Using a small amount of water, work||
5063|037|H|the product into the hair and scalp to form a lather. Leave on||
5063|038|H|for about 10 minutes or as long as directed by your doctor.||
5063|039|H|   Rinse and dry with a clean towel. Use a nit removal comb (a||
5063|040|H|fine-toothed comb) as directed to remove nits (lice eggs) from||
5063|041|H|hair. Wash hands immediately after use.||
5063|042|H|   Because this product does not affect the eggs (nits) laid by||
5063|043|H|lice, repeat the application once 7 to 10 days later to kill any||
5063|044|H|newly hatched lice.||
5063|045|H|   Tell your doctor if your condition lasts or gets worse after||
5063|046|H|the 2 treatments with this medication.||
5063|047|B|||
5063|048|S|SIDE EFFECTS:  Skin irritation may occur. If this effect lasts or||
5063|049|S|gets worse, tell your doctor or pharmacist promptly.||
5063|050|S|   If your doctor has directed you to use this medication,||
5063|051|S|remember that your doctor has judged that the benefit to you is||
5063|052|S|greater than the risk of side effects. Many people using this||
5063|053|S|medication do not have serious side effects.||
5063|054|S|   A very serious allergic reaction to this drug is rare.||
5063|055|S|However, get medical help right away if you notice any symptoms||
5063|056|S|of a serious allergic reaction, including: rash, itching/swelling||
5063|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5063|058|S|breathing.||
5063|059|S|   This is not a complete list of possible side effects. If you||
5063|060|S|notice other effects not listed above, contact your doctor or||
5063|061|S|pharmacist.||
5063|062|S|   In the US -||
5063|063|S|   Call your doctor for medical advice about side effects. You||
5063|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5063|065|S|www.fda.gov/medwatch.||
5063|066|S|   In Canada - Call your doctor for medical advice about side||
5063|067|S|effects. You may report side effects to Health Canada at||
5063|068|S|1-866-234-2345.||
5063|069|B|||
5063|070|P|PRECAUTIONS:  Before using pyrethrins/piperonyl butoxide, tell||
5063|071|P|your doctor or pharmacist if you are allergic to it; or to||
5063|072|P|chrysanthemum or ragweed; or if you have any other allergies.||
5063|073|P|This product may contain inactive ingredients, which can cause||
5063|074|P|allergic reactions or other problems. Talk to your pharmacist for||
5063|075|P|more details.||
5063|076|P|   Before using this medication, tell your doctor or pharmacist||
5063|077|P|your medical history, especially of: skin infections.||
5063|078|P|   Constant or hard scratching of the skin/scalp may lead to a||
5063|079|P|bacterial skin infection. Tell your doctor right away if you||
5063|080|P|develop worsening redness or pus.||
5063|081|P|   During pregnancy, this medication should be used only when||
5063|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
5063|083|P|   It is unknown if this drug passes into breast milk. Consult||
5063|084|P|your doctor before breastfeeding.||
5063|085|B|||
5063|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5063|087|I|medications work or increase your risk for serious side effects.||
5063|088|I|This document does not contain all possible drug interactions.||
5063|089|I|Keep a list of all the products you use (including||
5063|090|I|prescription/nonprescription drugs and herbal products) and share||
5063|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
5063|092|I|the dosage of any medicines without your doctor's approval.||
5063|093|B|||
5063|094|O|OVERDOSE:  This medicine may be harmful if inhaled or swallowed.||
5063|095|O|If someone has overdosed and has serious symptoms such as passing||
5063|096|O|out or trouble breathing, call 911. Otherwise, call a poison||
5063|097|O|control center right away. US residents can call 1-800-222-1222.||
5063|098|O|Canada residents can call 1-844-764-7669. Symptoms of overdose||
5063|099|O|may include: nausea, vomiting, diarrhea, unusual drowsiness.||
5063|100|B|||
5063|101|N|NOTES:  Do not share this medication with anyone else unless||
5063|102|N|directed by your doctor.||
5063|103|N|   To avoid giving lice to another person or getting them again,||
5063|104|N|all headwear, scarves, coats, and bed linens should be||
5063|105|N|machine-washed with hot water and dried in a dryer (at high||
5063|106|N|setting) for at least 20 minutes. These items may also be dry||
5063|107|N|cleaned, sealed in a plastic bag for 2 weeks, or sprayed with a||
5063|108|N|disinfectant that kills lice. Brushes and combs should be soaked||
5063|109|N|in hot water (hotter than 130 degrees F/54 degrees C) for 10||
5063|110|N|minutes, soaked in alcohol for 1 hour, or thrown away. Furniture||
5063|111|N|and floors should be thoroughly vacuumed.||
5063|112|N|   People who are in close contact with the infected person, such||
5063|113|N|as members of the same household, should also be checked for lice||
5063|114|N|and nits. Treatment may be considered to prevent infestation even||
5063|115|N|if live lice are not found on them.||
5063|116|B|||
5063|117|D|MISSED DOSE:  If you miss a dose, consult your doctor or||
5063|118|D|pharmacist.||
5063|119|B|||
5063|120|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
5063|121|R|medications away from children and pets.||
5063|122|R|   Do not flush medications down the toilet or pour them into a||
5063|123|R|drain unless instructed to do so. Properly discard this product||
5063|124|R|when it is expired or no longer needed. Consult your pharmacist||
5063|125|R|or local waste disposal company.||
5063|126|B|||
5063|127|A|Information last revised May 2024.||
5063|128|A|Copyright(c) 2025 First Databank, Inc.||
5063|129|B|||
5065|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5065|002|Z|does NOT have all possible information about this product. This||
5065|003|Z|information does not assure that this product is safe, effective,||
5065|004|Z|or appropriate for you. This information is not individual||
5065|005|Z|medical advice and does not substitute for the advice of your||
5065|006|Z|health care professional. Always ask your health care||
5065|007|Z|professional for complete information about this product and your||
5065|008|Z|specific health needs.||
5065|009|B|||
5065|010|T|CYCLOSERINE - ORAL||
5065|011|F|(sye-klo-SER-een)||
5065|012|B|||
5065|013|C|COMMON BRAND NAME(S): Seromycin||
5065|014|B|||
5065|015|U|USES:  This medication is used with other medications to treat||
5065|016|U|tuberculosis (TB). In some cases, it may also be used to treat||
5065|017|U|urinary tract infections (UTIs). It works by stopping the growth||
5065|018|U|of bacteria.||
5065|019|U|   This antibiotic treats only bacterial infections. It will not||
5065|020|U|work for viral infections (such as common cold, flu). Using any||
5065|021|U|antibiotic when it is not needed can cause it to not work for||
5065|022|U|future infections.||
5065|023|B|||
5065|024|H|HOW TO USE:  Take this medication by mouth with or without food||
5065|025|H|as directed by your doctor, usually twice daily (every 12 hours).||
5065|026|H|   The dosage is based on your weight, medical condition,||
5065|027|H|cycloserine blood levels, and response to treatment.||
5065|028|H|   For the best effect, take this antibiotic at evenly spaced||
5065|029|H|times. To help you remember, take this medication at the same||
5065|030|H|time(s) every day.||
5065|031|H|   Continue to take this medication (and other TB medications)||
5065|032|H|until the full prescribed amount is finished, even if symptoms||
5065|033|H|disappear. Stopping the medication too early or skipping doses||
5065|034|H|may result in a return of the infection and cause the infection||
5065|035|H|to be more difficult to treat (resistant).||
5065|036|H|   Your doctor may also direct you to take vitamin B6||
5065|037|H|(pyridoxine) to help prevent certain side effects from||
5065|038|H|cycloserine. Follow your doctor's instructions carefully.||
5065|039|H|   Tell your doctor if your condition lasts or gets worse.||
5065|040|B|||
5065|041|S|SIDE EFFECTS:  Headache, drowsiness, dizziness, or shaking||
5065|042|S|(tremor) may occur. If any of these effects last or get worse,||
5065|043|S|tell your doctor or pharmacist promptly.||
5065|044|S|   Remember that this medication has been prescribed because your||
5065|045|S|doctor has judged that the benefit to you is greater than the||
5065|046|S|risk of side effects. Many people using this medication do not||
5065|047|S|have serious side effects.||
5065|048|S|   Tell your doctor right away if you have any serious side||
5065|049|S|effects, including: weakness, mental/mood changes (such as||
5065|050|S|confusion, agitation, hallucination, depression, thoughts of||
5065|051|S|suicide), numb/tingling skin, seizures, irregular heartbeat,||
5065|052|S|symptoms of heart failure (such as shortness of breath, swelling||
5065|053|S|ankles/feet, unusual tiredness, unusual/sudden weight gain), pale||
5065|054|S|skin.||
5065|055|S|   A very serious allergic reaction to this drug is rare.||
5065|056|S|However, get medical help right away if you notice any symptoms||
5065|057|S|of a serious allergic reaction, including: rash, itching/swelling||
5065|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5065|059|S|breathing.||
5065|060|S|   This is not a complete list of possible side effects. If you||
5065|061|S|notice other effects not listed above, contact your doctor or||
5065|062|S|pharmacist.||
5065|063|S|   In the US -||
5065|064|S|   Call your doctor for medical advice about side effects. You||
5065|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5065|066|S|www.fda.gov/medwatch.||
5065|067|S|   In Canada - Call your doctor for medical advice about side||
5065|068|S|effects. You may report side effects to Health Canada at||
5065|069|S|1-866-234-2345.||
5065|070|B|||
5065|071|P|PRECAUTIONS:  Before taking cycloserine, tell your doctor or||
5065|072|P|pharmacist if you are allergic to it; or if you have any other||
5065|073|P|allergies. This product may contain inactive ingredients, which||
5065|074|P|can cause allergic reactions or other problems. Talk to your||
5065|075|P|pharmacist for more details.||
5065|076|P|   Before using this medication, tell your doctor or pharmacist||
5065|077|P|your medical history, especially of: seizures, mental/mood||
5065|078|P|disorders (such as depression, anxiety, psychosis), kidney||
5065|079|P|disease, liver disease, alcohol use.||
5065|080|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5065|081|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5065|082|P|machinery, or do anything that needs alertness until you can do||
5065|083|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5065|084|P|are using marijuana (cannabis).||
5065|085|P|   Cycloserine may cause live bacterial vaccines (such as typhoid||
5065|086|P|vaccine) to not work well. Tell your health care professional||
5065|087|P|that you are using cycloserine before having any||
5065|088|P|immunizations/vaccinations.||
5065|089|P|   Before having surgery, tell your doctor or dentist about all||
5065|090|P|the products you use (including prescription drugs,||
5065|091|P|nonprescription drugs, and herbal products).||
5065|092|P|   During pregnancy, this medication should be used only when||
5065|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
5065|094|P|   This medication passes into breast milk but is unlikely to||
5065|095|P|harm a nursing infant. Consult your doctor before breastfeeding.||
5065|096|B|||
5065|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5065|098|I|medications work or increase your risk for serious side effects.||
5065|099|I|This document does not contain all possible drug interactions.||
5065|100|I|Keep a list of all the products you use (including||
5065|101|I|prescription/nonprescription drugs and herbal products) and share||
5065|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
5065|103|I|the dosage of any medicines without your doctor's approval.||
5065|104|I|   Tell your doctor or pharmacist if you are taking other||
5065|105|I|products that cause drowsiness including alcohol, marijuana||
5065|106|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
5065|107|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
5065|108|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
5065|109|I|codeine).||
5065|110|I|   Check the labels on all your medicines (such as allergy or||
5065|111|I|cough-and-cold products) because they may contain ingredients||
5065|112|I|that cause drowsiness. Ask your pharmacist about using those||
5065|113|I|products safely.||
5065|114|B|||
5065|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5065|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5065|117|O|poison control center right away. US residents can call||
5065|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5065|119|O|Symptoms of overdose may include: numb/tingling skin, confusion,||
5065|120|O|agitation, hallucinations, seizures.||
5065|121|B|||
5065|122|N|NOTES:  Do not share this medication with others.||
5065|123|N|   Lab and/or medical tests (such as sputum test, cycloserine||
5065|124|N|blood levels, kidney/liver function, complete blood count) should||
5065|125|N|be done while you are taking this medication. Keep all medical||
5065|126|N|and lab appointments. Consult your doctor for more details.||
5065|127|B|||
5065|128|D|MISSED DOSE:  It is important to take each dose of this||
5065|129|D|medication as scheduled. If you miss a dose, take it as soon as||
5065|130|D|you remember. If it is near the time of the next dose, skip the||
5065|131|D|missed dose. Take your next dose at the regular time. Do not||
5065|132|D|double the dose to catch up.||
5065|133|B|||
5065|134|R|STORAGE:  Store at room temperature away from light and moisture.||
5065|135|R|Do not store in the bathroom. Keep all medications away from||
5065|136|R|children and pets.||
5065|137|R|   Do not flush medications down the toilet or pour them into a||
5065|138|R|drain unless instructed to do so. Properly discard this product||
5065|139|R|when it is expired or no longer needed. Consult your pharmacist||
5065|140|R|or local waste disposal company.||
5065|141|B|||
5065|142|A|Information last revised May 2024.||
5065|143|A|Copyright(c) 2025 First Databank, Inc.||
5065|144|B|||
5069|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5069|002|Z|does NOT have all possible information about this product. This||
5069|003|Z|information does not assure that this product is safe, effective,||
5069|004|Z|or appropriate for you. This information is not individual||
5069|005|Z|medical advice and does not substitute for the advice of your||
5069|006|Z|health care professional. Always ask your health care||
5069|007|Z|professional for complete information about this product and your||
5069|008|Z|specific health needs.||
5069|009|B|||
5069|010|T|FOSCARNET SODIUM - INJECTION||
5069|011|F|(foss-KAR-net)||
5069|012|B|||
5069|013|C|COMMON BRAND NAME(S): Foscavir||
5069|014|B|||
5069|015|W|WARNING:  This medication is used only for cytomegalovirus (CMV)||
5069|016|W|eye infections and acyclovir-resistant herpes infections.||
5069|017|W|   Foscarnet may cause serious side effects such as kidney||
5069|018|W|problems and seizures due to mineral/electrolyte imbalance. You||
5069|019|W|may be given fluids and/or minerals/electrolytes while receiving||
5069|020|W|this medication. Your doctor should check your kidney function||
5069|021|W|and lab tests while you are using this medication to decrease the||
5069|022|W|risk of these side effects. Tell your doctor right away if you||
5069|023|W|have any of signs of kidney problems or mineral/electrolyte||
5069|024|W|imbalance, such as change in the amount of urine,||
5069|025|W|numbness/tingling of arms/legs, tingling around the mouth,||
5069|026|W|seizures, muscle cramps/spasms, mental/mood changes, weakness, or||
5069|027|W|irregular heartbeat.||
5069|028|B|||
5069|029|U|USES:  This medication is used to control cytomegalovirus (CMV)||
5069|030|U|eye infections (CMV retinitis) in persons with AIDS. This||
5069|031|U|medication is an antiviral that works by stopping the growth of||
5069|032|U|viruses. Controlling CMV retinitis can help decrease the risk of||
5069|033|U|blindness from the infection. Foscarnet is sometimes combined||
5069|034|U|with another antiviral drug, ganciclovir, when the CMV infection||
5069|035|U|does not respond to either drug used alone for treatment.||
5069|036|U|   This medication is also used to treat herpes infections (HSV)||
5069|037|U|that do not respond to treatment with acyclovir||
5069|038|U|(acyclovir-resistant).||
5069|039|U|   This medication is not a cure for CMV or HSV diseases.||
5069|040|B|||
5069|041|V|OTHER USES:  This section contains uses of this drug that are not||
5069|042|V|listed in the approved professional labeling for the drug but||
5069|043|V|that may be prescribed by your health care professional. Use this||
5069|044|V|drug for a condition that is listed in this section only if it||
5069|045|V|has been so prescribed by your health care professional.||
5069|046|V|   This drug may also be used to reduce the risk of CMV disease||
5069|047|V|in people receiving cancer treatment (such as chemotherapy).||
5069|048|B|||
5069|049|H|HOW TO USE:  This medication is given by injection into a vein by||
5069|050|H|a health care professional. It is given as directed by your||
5069|051|H|doctor, usually 2 to 3 times a day for the first 2 to 3 weeks of||
5069|052|H|treatment, then once a day thereafter. It is usually infused||
5069|053|H|slowly over 1 to 2 hours using an infusion pump. Infusing this||
5069|054|H|medication too quickly can result in serious side effects.||
5069|055|H|   The dosage is based on your weight, medical condition, and||
5069|056|H|response to treatment.||
5069|057|H|   If you are using this medication at home, learn all||
5069|058|H|preparation and usage instruction from your health care||
5069|059|H|professional. Do not mix this product with any other medications.||
5069|060|H|Before using, check this product for particles or discoloration.||
5069|061|H|If either is present, do not use the liquid.||
5069|062|H|   To prevent kidney damage, it is important to drink plenty of||
5069|063|H|fluids while using this medication. Fluids may be given by||
5069|064|H|injection into a vein to make sure you get enough.||
5069|065|H|   Antivirals work best when the amount of medicine in your body||
5069|066|H|is kept at a constant level. Use this drug at evenly spaced||
5069|067|H|intervals.||
5069|068|H|   It is very important to keep using this medication exactly as||
5069|069|H|prescribed by your doctor. Stopping treatment too soon may result||
5069|070|H|in ineffective treatment.||
5069|071|H|   Do not use more of this drug or infuse it more often or faster||
5069|072|H|than prescribed by your doctor. Your condition will not improve||
5069|073|H|faster, and you may experience side effects.||
5069|074|H|   If skin contact with this drug occurs, flush with plenty of||
5069|075|H|water. If irritation occurs, contact your doctor right away.||
5069|076|H|   Learn how to store and discard medical supplies safely.||
5069|077|B|||
5069|078|S|SIDE EFFECTS:  See also Warning section.||
5069|079|S|   Nausea, vomiting, headache, diarrhea, dizziness, or||
5069|080|S|swelling/pain at the injection site may occur. If any of these||
5069|081|S|effects last or get worse, tell your doctor or pharmacist||
5069|082|S|promptly.||
5069|083|S|   Remember that this medication has been prescribed because your||
5069|084|S|doctor has judged that the benefit to you is greater than the||
5069|085|S|risk of side effects. Many people using this medication do not||
5069|086|S|have serious side effects.||
5069|087|S|   Tell your doctor right away if you have any serious side||
5069|088|S|effects, including: new vision problems, fast breathing, unusual||
5069|089|S|tiredness, painful urination, irritation/sores on the penis,||
5069|090|S|vaginal irritation/sores, signs of infection (such as sore throat||
5069|091|S|that doesn't go away, fever, chills).||
5069|092|S|   A very serious allergic reaction to this drug is rare.||
5069|093|S|However, get medical help right away if you notice any symptoms||
5069|094|S|of a serious allergic reaction, including: rash, itching/swelling||
5069|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5069|096|S|breathing.||
5069|097|S|   This is not a complete list of possible side effects. If you||
5069|098|S|notice other effects not listed above, contact your doctor or||
5069|099|S|pharmacist.||
5069|100|S|   In the US -||
5069|101|S|   Call your doctor for medical advice about side effects. You||
5069|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5069|103|S|www.fda.gov/medwatch.||
5069|104|S|   In Canada - Call your doctor for medical advice about side||
5069|105|S|effects. You may report side effects to Health Canada at||
5069|106|S|1-866-234-2345.||
5069|107|B|||
5069|108|P|PRECAUTIONS:  Before using foscarnet, tell your doctor or||
5069|109|P|pharmacist if you are allergic to it; or if you have any other||
5069|110|P|allergies. This product may contain inactive ingredients, which||
5069|111|P|can cause allergic reactions or other problems. Talk to your||
5069|112|P|pharmacist for more details.||
5069|113|P|   Before using this medication, tell your doctor or pharmacist||
5069|114|P|your medical history, especially of: liver disease, kidney||
5069|115|P|disease (including being on dialysis), dehydration, low||
5069|116|P|electrolyte levels (calcium, magnesium, potassium, phosphate),||
5069|117|P|nervous system problems (such as a history of seizures), a low||
5069|118|P|sodium diet.||
5069|119|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5069|120|P|can make you more dizzy. Do not drive, use machinery, or do||
5069|121|P|anything that needs alertness until you can do it safely. Limit||
5069|122|P|alcoholic beverages. Talk to your doctor if you are using||
5069|123|P|marijuana (cannabis).||
5069|124|P|   Before having surgery, tell your doctor or dentist about all||
5069|125|P|the products you use (including prescription drugs,||
5069|126|P|nonprescription drugs, and herbal products).||
5069|127|P|   Children may be more sensitive to the side effects of this||
5069|128|P|drug, especially the effects on developing bones.||
5069|129|P|   Older adults may be more sensitive to the side effects of this||
5069|130|P|drug, especially kidney problems.||
5069|131|P|   During pregnancy, this medication should be used only when||
5069|132|P|clearly needed. Discuss the risks and benefits with your doctor.||
5069|133|P|   It is unknown if this drug passes into breast milk. Because of||
5069|134|P|the possible risk to the infant, breastfeeding is not recommended||
5069|135|P|while using this drug. Consult your doctor before breastfeeding.||
5069|136|B|||
5069|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5069|138|I|medications work or increase your risk for serious side effects.||
5069|139|I|This document does not contain all possible drug interactions.||
5069|140|I|Keep a list of all the products you use (including||
5069|141|I|prescription/nonprescription drugs and herbal products) and share||
5069|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
5069|143|I|the dosage of any medicines without your doctor's approval.||
5069|144|I|   Some products that may interact with this drug include: drugs||
5069|145|I|that may harm the kidneys (including amphotericin B, cidofovir,||
5069|146|I|aminoglycosides such as amikacin/gentamicin/tobramycin),||
5069|147|I|pentamidine, "water pills" (diuretics), zidovudine.||
5069|148|B|||
5069|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5069|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5069|151|O|poison control center right away. US residents can call||
5069|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5069|153|O|Symptoms of overdose may include: seizures, tingling around the||
5069|154|O|mouth, numbness/tingling in arms/legs.||
5069|155|B|||
5069|156|N|NOTES:  Do not share this medication with others.||
5069|157|N|   This medication is usually first given in the hospital where||
5069|158|N|your condition can be monitored closely. Lab and/or medical tests||
5069|159|N|(such as kidney function, blood mineral levels, complete blood||
5069|160|N|count, eye exams) should be done while you are using this||
5069|161|N|medication. Keep all medical and lab appointments. Consult your||
5069|162|N|doctor for more details.||
5069|163|B|||
5069|164|D|MISSED DOSE:  It is important to get this medication as||
5069|165|D|scheduled. If you miss a dose, ask your doctor or pharmacist||
5069|166|D|right away for a new dosing schedule. Do not double the dose to||
5069|167|D|catch up.||
5069|168|B|||
5069|169|R|STORAGE:  Store at room temperature away from heat. Keep all||
5069|170|R|medications away from children and pets.||
5069|171|R|   Do not flush medications down the toilet or pour them into a||
5069|172|R|drain unless instructed to do so. Properly discard this product||
5069|173|R|when it is expired or no longer needed. Consult your pharmacist||
5069|174|R|or local waste disposal company.||
5069|175|B|||
5069|176|A|Information last revised May 2025.||
5069|177|A|Copyright(c) 2025 First Databank, Inc.||
5069|178|B|||
5072|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5072|002|Z|does NOT have all possible information about this product. This||
5072|003|Z|information does not assure that this product is safe, effective,||
5072|004|Z|or appropriate for you. This information is not individual||
5072|005|Z|medical advice and does not substitute for the advice of your||
5072|006|Z|health care professional. Always ask your health care||
5072|007|Z|professional for complete information about this product and your||
5072|008|Z|specific health needs.||
5072|009|B|||
5072|010|T|NEOMYCIN/POLYMYXIN/DEXAMETHASONE DROPS - OPHTHALMIC||
5072|011|F|(nee-oh-MY-sin/paw-lee-MIX-in/dex-uh-METH-uh-sown)||
5072|012|B|||
5072|013|C|COMMON BRAND NAME(S): Maxitrol||
5072|014|B|||
5072|015|U|USES:  This medication is used to treat conditions involving||
5072|016|U|swelling (inflammation) of the eyes and to treat or prevent||
5072|017|U|bacterial eye infections. This product contains neomycin and||
5072|018|U|polymyxin, antibiotics that work by stopping the growth of||
5072|019|U|bacteria. It also contains dexamethasone, an anti-inflammatory||
5072|020|U|corticosteroid that works by reducing swelling.||
5072|021|U|   This medication treats/prevents only bacterial eye infections.||
5072|022|U|It will not work for other types of eye infections and may worsen||
5072|023|U|them (such as infections caused by viruses, fungi, mycobacteria).||
5072|024|U|Unnecessary use or overuse of any antibiotic can lead to its||
5072|025|U|decreased effectiveness.||
5072|026|B|||
5072|027|H|HOW TO USE:  Use this medication in the affected eye(s) as||
5072|028|H|directed by your doctor, usually 4 to 6 times a day. To apply eye||
5072|029|H|drops, wash your hands first. To avoid contamination, do not||
5072|030|H|touch the dropper tip or let it touch your eye or any other||
5072|031|H|surface. Shake the bottle well before each dose.||
5072|032|H|   Do not wear contact lenses while you are using this medicine.||
5072|033|H|Sterilize contact lenses according to manufacturer's directions||
5072|034|H|and check with your doctor before you begin using them again.||
5072|035|H|   Tilt your head back, look upward, and pull down the lower||
5072|036|H|eyelid to make a pouch. Hold the dropper directly over your eye||
5072|037|H|and place one drop into the pouch. Look downward and gently close||
5072|038|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
5072|039|H|your eye (near the nose) and apply gentle pressure. This will||
5072|040|H|prevent the medication from draining out. Try not to blink and do||
5072|041|H|not rub your eye. Repeat these steps if your dose is for more||
5072|042|H|than 1 drop and for your other eye if so directed. The dosage is||
5072|043|H|based on your medical condition and response to treatment.||
5072|044|H|   Do not rinse the dropper. Replace the dropper cap after each||
5072|045|H|use.||
5072|046|H|   If you are using another kind of eye medication (such as drops||
5072|047|H|or ointments), wait at least 5 minutes before applying other||
5072|048|H|medications. Use eye drops before eye ointments to allow the eye||
5072|049|H|drops to enter the eye.||
5072|050|H|   Do not use this medication more often than prescribed or for||
5072|051|H|longer than 10 days unless directed by your doctor.||
5072|052|H|   Wait several minutes for your vision to clear before driving||
5072|053|H|or operating machinery.||
5072|054|H|   Use this medication regularly in order to get the most benefit||
5072|055|H|from it. To help you remember, use it at the same times each day.||
5072|056|H|Continue to use this medication for the full time prescribed,||
5072|057|H|even if symptoms disappear after a few days. Stopping the||
5072|058|H|medication too early may result in a return of the infection.||
5072|059|H|   Tell your doctor if your condition does not get better in a||
5072|060|H|few days.||
5072|061|B|||
5072|062|S|SIDE EFFECTS:  Stinging/burning of the eyes for 1 to 2 minutes||
5072|063|S|may occur when this medication is applied. If any of these||
5072|064|S|effects last or get worse, tell your doctor or pharmacist||
5072|065|S|promptly.||
5072|066|S|   Remember that this medication has been prescribed because your||
5072|067|S|doctor has judged that the benefit to you is greater than the||
5072|068|S|risk of side effects. Many people using this medication do not||
5072|069|S|have serious side effects.||
5072|070|S|   Use of this medication for prolonged/repeated periods may||
5072|071|S|result in a new fungal eye infection and may increase your risk||
5072|072|S|for other eye problems (such as glaucoma, cataracts, delayed||
5072|073|S|wound healing). Do not use this medication for longer than||
5072|074|S|prescribed. Tell your doctor right away if any of these unlikely||
5072|075|S|but serious side effects occur: new or worsening eye symptoms||
5072|076|S|(such as discharge, swelling, redness), vision problems, eye||
5072|077|S|pain.||
5072|078|S|   A very serious allergic reaction to this drug is rare.||
5072|079|S|However, get medical help right away if you notice any symptoms||
5072|080|S|of a serious allergic reaction, including: rash, itching/swelling||
5072|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5072|082|S|breathing.||
5072|083|S|   This is not a complete list of possible side effects. If you||
5072|084|S|notice other effects not listed above, contact your doctor or||
5072|085|S|pharmacist.||
5072|086|S|   In the US -||
5072|087|S|   Call your doctor for medical advice about side effects. You||
5072|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5072|089|S|www.fda.gov/medwatch.||
5072|090|S|   In Canada - Call your doctor for medical advice about side||
5072|091|S|effects. You may report side effects to Health Canada at||
5072|092|S|1-866-234-2345.||
5072|093|B|||
5072|094|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
5072|095|P|pharmacist if you are allergic to neomycin, polymyxin, or||
5072|096|P|dexamethasone; or to aminoglycoside antibiotics (such as||
5072|097|P|gentamicin, tobramycin); or to corticosteroids (such as||
5072|098|P|hydrocortisone, prednisone); or if you have any other allergies.||
5072|099|P|This product may contain inactive ingredients (such as||
5072|100|P|preservatives like benzalkonium chloride), which can cause||
5072|101|P|allergic reactions or other problems. Talk to your pharmacist for||
5072|102|P|more details.||
5072|103|P|   Before using this medication, tell your doctor or pharmacist||
5072|104|P|your medical history, especially of: other eye problems (such as||
5072|105|P|glaucoma).||
5072|106|P|   After you apply this drug, your vision may become temporarily||
5072|107|P|blurred or unstable. Do not drive, use machinery, or do anything||
5072|108|P|that needs clear vision until you can do it safely.||
5072|109|P|   During pregnancy, this medication should be used only when||
5072|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
5072|111|P|   It is unknown if this drug passes into breast milk. Consult||
5072|112|P|your doctor before breastfeeding.||
5072|113|B|||
5072|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5072|115|I|medications work or increase your risk for serious side effects.||
5072|116|I|This document does not contain all possible drug interactions.||
5072|117|I|Keep a list of all the products you use (including||
5072|118|I|prescription/nonprescription drugs and herbal products) and share||
5072|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
5072|120|I|the dosage of any medicines without your doctor's approval.||
5072|121|B|||
5072|122|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5072|123|O|has overdosed and has serious symptoms such as passing out or||
5072|124|O|trouble breathing, call 911. Otherwise, call a poison control||
5072|125|O|center right away. US residents can call 1-800-222-1222. Canada||
5072|126|O|residents can call 1-844-764-7669.||
5072|127|B|||
5072|128|N|NOTES:  Do not share this medication with others.||
5072|129|N|   This medication has been prescribed for your current condition||
5072|130|N|only. Throw away the unused medication after treatment is||
5072|131|N|completed. Do not use it later for another infection unless your||
5072|132|N|doctor tells you to.||
5072|133|N|   If you use this medication for 10 days or longer, lab and/or||
5072|134|N|medical tests (such as eye exams) should be done while you are||
5072|135|N|using this medication. Keep all medical and lab appointments.||
5072|136|N|Consult your doctor for more details.||
5072|137|B|||
5072|138|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5072|139|D|If it is near the time of the next dose, skip the missed dose.||
5072|140|D|Use your next dose at the regular time. Do not double the dose to||
5072|141|D|catch up.||
5072|142|B|||
5072|143|R|STORAGE:  Store at room temperature. Some brands may also need to||
5072|144|R|be stored upright. Check the product package for instructions on||
5072|145|R|how to store your brand, or ask your pharmacist. Throw away this||
5072|146|R|medication and do not use it if the solution turns brown or||
5072|147|R|cloudy or contains particles. Keep all medications away from||
5072|148|R|children and pets.||
5072|149|R|   Do not flush medications down the toilet or pour them into a||
5072|150|R|drain unless instructed to do so. Properly discard this product||
5072|151|R|when it is expired or no longer needed. Consult your pharmacist||
5072|152|R|or local waste disposal company.||
5072|153|B|||
5072|154|A|Information last revised November 2024.||
5072|155|A|Copyright(c) 2025 First Databank, Inc.||
5072|156|B|||
5073|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5073|002|Z|does NOT have all possible information about this product. This||
5073|003|Z|information does not assure that this product is safe, effective,||
5073|004|Z|or appropriate for you. This information is not individual||
5073|005|Z|medical advice and does not substitute for the advice of your||
5073|006|Z|health care professional. Always ask your health care||
5073|007|Z|professional for complete information about this product and your||
5073|008|Z|specific health needs.||
5073|009|B|||
5073|010|T|DOXYCYCLINE 20 MG - ORAL||
5073|011|F|(dox-ee-SYE-kleen)||
5073|012|B|||
5073|013|C|COMMON BRAND NAME(S): Periostat||
5073|014|B|||
5073|015|U|USES:  This product is used in patients with gum disease||
5073|016|U|(periodontitis) after a certain dental procedure (scaling and||
5073|017|U|root planing). It helps to improve tooth attachment and reduce||
5073|018|U|gum pockets.||
5073|019|U|   Doxycycline belongs to the class of antibiotics known as||
5073|020|U|tetracyclines. At this low dosage, this medication does not treat||
5073|021|U|bacterial infections, but it may help to prevent breakdown of gum||
5073|022|U|tissue. Antibiotics do not work for viral infections (such as||
5073|023|U|common cold, flu). Unnecessary use or misuse of any antibiotic||
5073|024|U|can lead to its decreased effectiveness.||
5073|025|B|||
5073|026|H|HOW TO USE:  This medication is best taken by mouth on an empty||
5073|027|H|stomach (at least 1 hour before or 2 hours after a meal) as||
5073|028|H|directed by your doctor, usually 1 or 2 times daily. Take this||
5073|029|H|medication with a full glass of water (8 ounces/240 milliliters)||
5073|030|H|unless directed otherwise. If stomach upset occurs, taking it||
5073|031|H|with food or milk may help. However, doxycycline may not work as||
5073|032|H|well if you take it with food or milk (or anything high in||
5073|033|H|calcium - more details below), so ask your doctor or pharmacist||
5073|034|H|if you may take it that way. Do not lie down for at least 10||
5073|035|H|minutes after taking this medication.||
5073|036|H|   Take this medication 2 to 3 hours before or after taking any||
5073|037|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
5073|038|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
5073|039|H|sucralfate, vitamins/minerals, dairy products (such as milk,||
5073|040|H|yogurt), and juice with added calcium. These products bind with||
5073|041|H|doxycycline, preventing your body from fully absorbing the drug.||
5073|042|H|   For the best effect, take this antibiotic at evenly spaced||
5073|043|H|times. To help you remember, take this medication at the same||
5073|044|H|time(s) every day.||
5073|045|B|||
5073|046|S|SIDE EFFECTS:  Stomach upset, diarrhea, nausea, or vomiting may||
5073|047|S|occur. If any of these effects last or get worse, tell your||
5073|048|S|doctor or pharmacist promptly.||
5073|049|S|   Remember that this medication has been prescribed because your||
5073|050|S|doctor has judged that the benefit to you is greater than the||
5073|051|S|risk of side effects. Many people using this medication do not||
5073|052|S|have serious side effects.||
5073|053|S|   Tell your doctor right away if you have any serious side||
5073|054|S|effects, including: painful/difficult swallowing, signs of kidney||
5073|055|S|problems (such as change in the amount of urine).||
5073|056|S|   Tetracycline drugs such as doxycycline may rarely cause||
5073|057|S|increased pressure around the brain (intracranial||
5073|058|S|hypertension-IH). The risk of this side effect is greater for||
5073|059|S|women of childbearing age who are overweight or who have had IH||
5073|060|S|in the past. If IH develops, it usually goes away after||
5073|061|S|doxycycline is stopped; however, there is a chance of permanent||
5073|062|S|vision loss or blindness. Get medical help right away if you||
5073|063|S|have: headache that is severe or doesn't go away, nausea/vomiting||
5073|064|S|that doesn't stop, vision changes (such as blurred/double vision,||
5073|065|S|decreased vision, sudden blindness).||
5073|066|S|   This medication may rarely cause a severe intestinal condition||
5073|067|S|due to a bacteria called C. difficile. This condition may occur||
5073|068|S|during treatment or weeks to months after treatment has stopped.||
5073|069|S|Tell your doctor right away if you develop: diarrhea that doesn't||
5073|070|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
5073|071|S|stool.||
5073|072|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
5073|073|S|products because they may make symptoms worse.||
5073|074|S|   Use of this medication for prolonged or repeated periods may||
5073|075|S|result in oral thrush or a new vaginal yeast infection. Contact||
5073|076|S|your doctor if you notice white patches in your mouth, a change||
5073|077|S|in vaginal discharge, or other new symptoms.||
5073|078|S|   A very serious allergic reaction to this drug is rare.||
5073|079|S|However, get medical help right away if you notice any symptoms||
5073|080|S|of a serious allergic reaction, including: fever that doesn't go||
5073|081|S|away, new or worsening lymph node swelling, rash,||
5073|082|S|itching/swelling (especially of the face/tongue/throat), severe||
5073|083|S|dizziness, trouble breathing.||
5073|084|S|   This is not a complete list of possible side effects. If you||
5073|085|S|notice other effects not listed above, contact your doctor or||
5073|086|S|pharmacist.||
5073|087|S|   In the US -||
5073|088|S|   Call your doctor for medical advice about side effects. You||
5073|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5073|090|S|www.fda.gov/medwatch.||
5073|091|S|   In Canada - Call your doctor for medical advice about side||
5073|092|S|effects. You may report side effects to Health Canada at||
5073|093|S|1-866-234-2345.||
5073|094|B|||
5073|095|P|PRECAUTIONS:  See also Side Effects section.||
5073|096|P|   Before taking doxycycline, tell your doctor or pharmacist if||
5073|097|P|you are allergic to it; or to other tetracyclines (such as||
5073|098|P|minocycline); or if you have any other allergies. This product||
5073|099|P|may contain inactive ingredients, which can cause allergic||
5073|100|P|reactions or other problems. Talk to your pharmacist for more||
5073|101|P|details.||
5073|102|P|   Before using this medication, tell your doctor or pharmacist||
5073|103|P|your medical history, especially of: trouble swallowing,||
5073|104|P|esophagus problems (such as hiatal hernia or reflux/heartburn).||
5073|105|P|   Doxycycline may cause live bacterial vaccines (such as typhoid||
5073|106|P|vaccine) to not work well. Tell your health care professional||
5073|107|P|that you are using doxycycline before having any||
5073|108|P|immunizations/vaccinations.||
5073|109|P|   Before having surgery, tell your doctor or dentist about all||
5073|110|P|the products you use (including prescription drugs,||
5073|111|P|nonprescription drugs, and herbal products).||
5073|112|P|   This medication may make you more sensitive to the sun. Limit||
5073|113|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5073|114|P|sunscreen and wear protective clothing when outdoors. Tell your||
5073|115|P|doctor right away if you get sunburned or have skin||
5073|116|P|blisters/redness.||
5073|117|P|   Children younger than 8 years may be more sensitive to the||
5073|118|P|side effects of doxycycline, especially tooth discoloration.||
5073|119|P|Tooth discoloration has also occurred in older children and young||
5073|120|P|adults. Discuss the risks and benefits of this medication with||
5073|121|P|the doctor.||
5073|122|P|   Tell your doctor if you are pregnant or plan to become||
5073|123|P|pregnant. You should not become pregnant while using doxycycline.||
5073|124|P|Doxycycline may harm an unborn baby. If you become pregnant, talk||
5073|125|P|to your doctor right away about the risks and benefits of this||
5073|126|P|medication.||
5073|127|P|   This medication passes into breast milk. Consult your doctor||
5073|128|P|before breastfeeding.||
5073|129|B|||
5073|130|I|DRUG INTERACTIONS:  See also How to Use section.||
5073|131|I|   Drug interactions may change how your medications work or||
5073|132|I|increase your risk for serious side effects. This document does||
5073|133|I|not contain all possible drug interactions. Keep a list of all||
5073|134|I|the products you use (including prescription/nonprescription||
5073|135|I|drugs and herbal products) and share it with your doctor and||
5073|136|I|pharmacist. Do not start, stop, or change the dosage of any||
5073|137|I|medicines without your doctor's approval.||
5073|138|I|   Some products that may interact with this drug include:||
5073|139|I|retinoid medications taken by mouth (such as acitretin,||
5073|140|I|isotretinoin), strontium.||
5073|141|I|   This medication may interfere with certain lab tests (such as||
5073|142|I|urine catecholamine levels), possibly causing false test results.||
5073|143|I|Make sure lab personnel and all your doctors know you use this||
5073|144|I|drug.||
5073|145|B|||
5073|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5073|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5073|148|O|poison control center right away. US residents can call||
5073|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5073|150|B|||
5073|151|N|NOTES:  Do not share this medication with others.||
5073|152|N|   This medication has been prescribed for your current condition||
5073|153|N|only. Do not use it later for another condition unless told to do||
5073|154|N|so by your doctor. A different medication may be necessary in||
5073|155|N|those cases.||
5073|156|N|   Proper dental hygiene may help prevent tooth and gum problems.||
5073|157|N|Discuss with your dentist.||
5073|158|N|   Lab and/or medical tests (such as dental exams, liver/kidney||
5073|159|N|function) may be done while you are taking this medication. Keep||
5073|160|N|all medical and lab appointments. Consult your doctor for more||
5073|161|N|details.||
5073|162|B|||
5073|163|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5073|164|D|remember. If it is near the time of the next dose, skip the||
5073|165|D|missed dose. Take your next dose at the regular time. Do not||
5073|166|D|double the dose to catch up.||
5073|167|B|||
5073|168|R|STORAGE:  Store at room temperature away from light and moisture.||
5073|169|R|Do not store in the bathroom. Keep all medications away from||
5073|170|R|children and pets.||
5073|171|R|   Do not flush medications down the toilet or pour them into a||
5073|172|R|drain unless instructed to do so. Properly discard this product||
5073|173|R|when it is expired or no longer needed. Taking outdated||
5073|174|R|tetracycline-related drugs can result in serious illness. Consult||
5073|175|R|your pharmacist or local waste disposal company.||
5073|176|B|||
5073|177|A|Information last revised September 2025.||
5073|178|A|Copyright(c) 2025 First Databank, Inc.||
5073|179|B|||
5075|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5075|002|Z|does NOT have all possible information about this product. This||
5075|003|Z|information does not assure that this product is safe, effective,||
5075|004|Z|or appropriate for you. This information is not individual||
5075|005|Z|medical advice and does not substitute for the advice of your||
5075|006|Z|health care professional. Always ask your health care||
5075|007|Z|professional for complete information about this product and your||
5075|008|Z|specific health needs.||
5075|009|B|||
5075|010|T|BENAZEPRIL/HYDROCHLOROTHIAZIDE - ORAL||
5075|011|F|(ben-AZ-e-pril/HYE-droe-KLOR-oh-THYE-a-zide)||
5075|012|B|||
5075|013|C|COMMON BRAND NAME(S): Lotensin HCT||
5075|014|B|||
5075|015|W|WARNING:  This drug can cause serious harm to an unborn baby||
5075|016|W|(possibly fatal) if used during pregnancy. It is important to||
5075|017|W|prevent pregnancy while taking this medication. Consult your||
5075|018|W|doctor for more details and to discuss the use of reliable forms||
5075|019|W|of birth control while taking this medication. If you are||
5075|020|W|planning pregnancy, become pregnant, or think you may be||
5075|021|W|pregnant, contact your doctor right away.||
5075|022|B|||
5075|023|U|USES:  This medication is a combination of two drugs, an ACE||
5075|024|U|inhibitor (benazepril) and a "water pill"/diuretic||
5075|025|U|(hydrochlorothiazide). It is used to treat high blood pressure||
5075|026|U|(hypertension). Benazepril works by relaxing blood vessels,||
5075|027|U|causing them to widen. The hydrochlorothiazide diuretic increases||
5075|028|U|the amount of urine you make, which decreases excess water and||
5075|029|U|salt in your body. Lowering high blood pressure helps prevent||
5075|030|U|strokes, heart attacks, and kidney problems.||
5075|031|B|||
5075|032|V|OTHER USES:  This section contains uses of this drug that are not||
5075|033|V|listed in the approved professional labeling for the drug but||
5075|034|V|that may be prescribed by your health care professional. Use this||
5075|035|V|drug for a condition that is listed in this section only if it||
5075|036|V|has been so prescribed by your health care professional.||
5075|037|V|   This drug may also be used for heart failure.||
5075|038|B|||
5075|039|H|HOW TO USE:  Take this medication by mouth with or without food||
5075|040|H|as directed by your doctor, usually once a day. If this||
5075|041|H|medication causes you to urinate more often, it is best to take||
5075|042|H|it at least 4 hours before your bedtime to prevent having to get||
5075|043|H|up to urinate.||
5075|044|H|   If you are also taking cholestyramine or colestipol, take||
5075|045|H|benazepril/hydrochlorothiazide at least 4 hours before or at||
5075|046|H|least 4 to 6 hours after either of those drugs.||
5075|047|H|   The dosage is based on your medical condition and response to||
5075|048|H|treatment. For the treatment of high blood pressure, it may take||
5075|049|H|2 weeks before the full benefit of this drug occurs or several||
5075|050|H|weeks to months when used for heart failure.||
5075|051|H|   Use this medication regularly in order to get the most benefit||
5075|052|H|from it. To help you remember, take it at the same time each day.||
5075|053|H|Keep taking this medication even if you feel well. Most people||
5075|054|H|with high blood pressure do not feel sick.||
5075|055|H|   Tell your doctor if your condition does not get better or if||
5075|056|H|it gets worse (your blood pressure readings remain high or||
5075|057|H|increase).||
5075|058|B|||
5075|059|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, headache,||
5075|060|S|tiredness, blurred vision, dry cough, or vomiting may occur as||
5075|061|S|your body adjusts to the medication. If any of these effects last||
5075|062|S|or get worse, tell your doctor or pharmacist promptly.||
5075|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
5075|064|S|slowly when rising from a sitting or lying position.||
5075|065|S|   Remember that this medication has been prescribed because your||
5075|066|S|doctor has judged that the benefit to you is greater than the||
5075|067|S|risk of side effects. Many people using this medication do not||
5075|068|S|have serious side effects.||
5075|069|S|   This medication may cause dehydration and electrolyte||
5075|070|S|imbalance. Tell your doctor right away if you have any symptoms||
5075|071|S|of dehydration or electrolyte imbalance, including unusual dry||
5075|072|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
5075|073|S|heartbeat, or confusion.||
5075|074|S|   Tell your doctor right away if you have any serious side||
5075|075|S|effects, including: fainting, decreased sexual ability, tingling||
5075|076|S|or numbness of the hands/feet, decrease in vision, eye pain,||
5075|077|S|signs of kidney problems (such as change in the amount of urine).||
5075|078|S|   This product may rarely cause serious (possibly fatal) liver||
5075|079|S|problems. Get medical help right away if you have any symptoms of||
5075|080|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
5075|081|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
5075|082|S|urine.||
5075|083|S|   A very serious allergic reaction to this drug is rare.||
5075|084|S|However, get medical help right away if you notice any symptoms||
5075|085|S|of a serious allergic reaction, including: rash, itching/swelling||
5075|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5075|087|S|breathing.||
5075|088|S|   This is not a complete list of possible side effects. If you||
5075|089|S|notice other effects not listed above, contact your doctor or||
5075|090|S|pharmacist.||
5075|091|S|   In the US -||
5075|092|S|   Call your doctor for medical advice about side effects. You||
5075|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5075|094|S|www.fda.gov/medwatch.||
5075|095|S|   In Canada - Call your doctor for medical advice about side||
5075|096|S|effects. You may report side effects to Health Canada at||
5075|097|S|1-866-234-2345.||
5075|098|B|||
5075|099|P|PRECAUTIONS:  Before taking benazepril with hydrochlorothiazide,||
5075|100|P|tell your doctor or pharmacist if you are allergic to it; or to||
5075|101|P|other ACE inhibitors (such as captopril, lisinopril); or if you||
5075|102|P|have any other allergies (including an allergic reaction after||
5075|103|P|exposure to certain membranes used for blood filtering). This||
5075|104|P|product may contain inactive ingredients, which can cause||
5075|105|P|allergic reactions or other problems. Talk to your pharmacist for||
5075|106|P|more details.||
5075|107|P|   Before using this medication, tell your doctor or pharmacist||
5075|108|P|your medical history, especially of: kidney disease (such as||
5075|109|P|anuria), liver disease, history of an allergic reaction which||
5075|110|P|included swelling of the face/lips/tongue/throat (angioedema),||
5075|111|P|severe loss of body fluids (dehydration through excessive||
5075|112|P|sweating, vomiting, or diarrhea), mineral/electrolyte problems||
5075|113|P|(such as imbalance of sodium, potassium, magnesium, calcium),||
5075|114|P|gout, lupus, asthma, skin cancer.||
5075|115|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5075|116|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5075|117|P|machinery, or do anything that needs alertness until you can do||
5075|118|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5075|119|P|are using marijuana (cannabis).||
5075|120|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
5075|121|P|and cause you to feel lightheaded. Tell your doctor if you have||
5075|122|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
5075|123|P|of fluids unless your doctor tells you not to.||
5075|124|P|   This product may affect your potassium levels. Before using||
5075|125|P|potassium supplements or salt substitutes that contain potassium,||
5075|126|P|consult your doctor or pharmacist.||
5075|127|P|   Before having surgery, tell your doctor or dentist about all||
5075|128|P|the products you use (including prescription drugs,||
5075|129|P|nonprescription drugs, and herbal products).||
5075|130|P|   This medication may make you more sensitive to the sun. It may||
5075|131|P|also increase your risk for skin cancer, especially if you take||
5075|132|P|it for a long time. Limit your time in the sun. Avoid tanning||
5075|133|P|booths and sunlamps. Use sunscreen and wear protective clothing||
5075|134|P|when outdoors. Tell your doctor right away if you get sunburned,||
5075|135|P|have skin blisters/redness, or notice new or changed moles/skin||
5075|136|P|lesions.||
5075|137|P|   If you have diabetes, hydrochlorothiazide may affect your||
5075|138|P|blood sugar. Check your blood sugar regularly as directed and||
5075|139|P|share the results with your doctor. Tell your doctor right away||
5075|140|P|if you have symptoms of high blood sugar such as increased||
5075|141|P|thirst/urination. Your doctor may need to adjust your diabetes||
5075|142|P|medication, exercise program, or diet.||
5075|143|P|   Older adults may be more sensitive to the side effects of this||
5075|144|P|drug, especially dizziness and change in the amount of urine||
5075|145|P|(kidney problems).||
5075|146|P|   Tell your doctor if you are pregnant or plan to become||
5075|147|P|pregnant. You should not become pregnant while using this||
5075|148|P|medication. Benazepril may harm an unborn baby. If you become||
5075|149|P|pregnant, talk to your doctor right away about the risks and||
5075|150|P|benefits of this medication. See also Warning section.||
5075|151|P|   This product passes into breast milk. Consult your doctor||
5075|152|P|before breastfeeding.||
5075|153|B|||
5075|154|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
5075|155|I|   Drug interactions may change how your medications work or||
5075|156|I|increase your risk for serious side effects. This document does||
5075|157|I|not contain all possible drug interactions. Keep a list of all||
5075|158|I|the products you use (including prescription/nonprescription||
5075|159|I|drugs and herbal products) and share it with your doctor and||
5075|160|I|pharmacist. Do not start, stop, or change the dosage of any||
5075|161|I|medicines without your doctor's approval.||
5075|162|I|   Some products that may interact with this drug are: aliskiren,||
5075|163|I|dofetilide, certain drugs that weaken the immune system/increase||
5075|164|I|the risk of infection (such as everolimus, sirolimus), drugs that||
5075|165|I|may increase the level of potassium in the blood (such as ARBs||
5075|166|I|including losartan/valsartan, birth control pills containing||
5075|167|I|drospirenone), lithium, probenecid, gold injections, sacubitril.||
5075|168|I|   A very serious reaction may occur if you are getting||
5075|169|I|injections for bee/wasp sting allergy (desensitization) and are||
5075|170|I|also taking benazepril with hydrochlorothiazide. Make sure all||
5075|171|I|your doctors know which medicines you are using.||
5075|172|I|   Some products have ingredients that could raise your blood||
5075|173|I|pressure or worsen your heart failure. Tell your pharmacist what||
5075|174|I|products you are using, and ask how to use them safely||
5075|175|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
5075|176|I|ibuprofen/naproxen).||
5075|177|B|||
5075|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5075|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5075|180|O|poison control center right away. US residents can call||
5075|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5075|182|O|Symptoms of overdose may include: unusually fast or slow||
5075|183|O|heartbeat, severe dizziness, or fainting.||
5075|184|B|||
5075|185|N|NOTES:  Do not share this medication with others. Lifestyle||
5075|186|N|changes such as stress reduction programs, exercise and dietary||
5075|187|N|changes may increase the effectiveness of this medicine. Talk to||
5075|188|N|your doctor or pharmacist about lifestyle changes that might||
5075|189|N|benefit you.||
5075|190|N|   Lab and/or medical tests (such as kidney function, potassium||
5075|191|N|blood level, skin exams, cholesterol levels) should be done while||
5075|192|N|you are taking this medication. Keep all medical and lab||
5075|193|N|appointments. Consult your doctor for more details.||
5075|194|N|   Check your blood pressure regularly while taking this||
5075|195|N|medication, especially when you first start this drug or when||
5075|196|N|your dose is changed. Learn how to monitor your own blood||
5075|197|N|pressure at home, and share the results with your doctor.||
5075|198|B|||
5075|199|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5075|200|D|If it is near the time of the next dose, skip the missed dose.||
5075|201|D|Use your next dose at the regular time. Do not double the dose to||
5075|202|D|catch up.||
5075|203|B|||
5075|204|R|STORAGE:  Store at room temperature away from light and moisture.||
5075|205|R|Do not store in the bathroom. Keep all medications away from||
5075|206|R|children and pets.||
5075|207|R|   Do not flush medications down the toilet or pour them into a||
5075|208|R|drain unless instructed to do so. Properly discard this product||
5075|209|R|when it is expired or no longer needed. Consult your pharmacist||
5075|210|R|or local waste disposal company.||
5075|211|B|||
5075|212|A|Information last revised April 2025.||
5075|213|A|Copyright(c) 2025 First Databank, Inc.||
5075|214|B|||
5081|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5081|002|Z|does NOT have all possible information about this product. This||
5081|003|Z|information does not assure that this product is safe, effective,||
5081|004|Z|or appropriate for you. This information is not individual||
5081|005|Z|medical advice and does not substitute for the advice of your||
5081|006|Z|health care professional. Always ask your health care||
5081|007|Z|professional for complete information about this product and your||
5081|008|Z|specific health needs.||
5081|009|B|||
5081|010|T|CODEINE/BUTALBITAL/ASPIRIN/CAFFEINE - ORAL||
5081|011|F|(KOE-deen/byou-TAL-bih-tall/AS-pir-in/KAF-een)||
5081|012|B|||
5081|013|C|COMMON BRAND NAME(S): Fiorinal with Codeine #3||
5081|014|B|||
5081|015|W|WARNING:  Codeine has a risk for abuse and addiction, which can||
5081|016|W|lead to overdose and death. Codeine may also cause severe,||
5081|017|W|possibly fatal, breathing problems. To lower your risk, your||
5081|018|W|doctor should have you take the smallest dose of codeine that||
5081|019|W|works, and take it for the shortest possible time. See also How||
5081|020|W|to Use section for more information about addiction.||
5081|021|W|   Ask your doctor or pharmacist if you should have medication||
5081|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
5081|023|W|Teach your family or household members about the signs of an||
5081|024|W|opioid overdose and how to treat it.||
5081|025|W|   The risk for severe breathing problems is higher when you||
5081|026|W|start this medication and after a dose increase, or if you take||
5081|027|W|the wrong dose/strength. Taking this medication with alcohol or||
5081|028|W|other drugs that can cause drowsiness or breathing problems may||
5081|029|W|cause very serious side effects, including death. Also, other||
5081|030|W|medications can affect the removal of codeine from your body,||
5081|031|W|which may affect how codeine works. Be sure you know how to take||
5081|032|W|this medication and what other drugs you should avoid taking with||
5081|033|W|it. See also Drug Interactions section. Get medical help right||
5081|034|W|away if any of these very serious side effects occur:||
5081|035|W|slow/shallow breathing, unusual lightheadedness, severe||
5081|036|W|drowsiness/dizziness, difficulty waking up.||
5081|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
5081|038|W|or abuse. If someone accidentally swallows this medication, get||
5081|039|W|medical help right away.||
5081|040|W|   Children younger than 18 years should not use products that||
5081|041|W|contain codeine. Some children are more sensitive to codeine and||
5081|042|W|have had very serious (rarely fatal) breathing problems such as||
5081|043|W|slow/shallow breathing (see also Side Effects section). The risk||
5081|044|W|is greater in children who are obese or have breathing problems,||
5081|045|W|or after certain surgeries (including tonsil/adenoid removal).||
5081|046|W|Talk with your doctor or pharmacist about the risks and benefits||
5081|047|W|of this medication.||
5081|048|B|||
5081|049|U|USES:  See also Warning section.||
5081|050|U|   This combination medication is used to treat tension||
5081|051|U|headaches. Codeine is an opioid pain reliever that acts on||
5081|052|U|certain centers in the brain to give you pain relief. Aspirin||
5081|053|U|helps to decrease the pain from the headache. Caffeine helps||
5081|054|U|increase the effects of aspirin. Butalbital is a sedative that||
5081|055|U|helps to decrease anxiety and cause sleepiness and relaxation.||
5081|056|B|||
5081|057|V|OTHER USES:  This section contains uses of this drug that are not||
5081|058|V|listed in the approved professional labeling for the drug but||
5081|059|V|that may be prescribed by your health care professional. Use this||
5081|060|V|drug for a condition that is listed in this section only if it||
5081|061|V|has been so prescribed by your health care professional.||
5081|062|V|   This drug may also be used for migraine headaches.||
5081|063|B|||
5081|064|H|HOW TO USE:  Read the Medication Guide provided by your||
5081|065|H|pharmacist before you start taking this product and each time you||
5081|066|H|get a refill. If you have any questions, ask your doctor or||
5081|067|H|pharmacist.||
5081|068|H|   Take this medication by mouth as directed by your doctor,||
5081|069|H|usually every 4 hours as needed. Do not take more than 6 capsules||
5081|070|H|in a 24-hour period. Use the smallest effective dose. Take with a||
5081|071|H|full glass of water (8 ounces or 240 milliliters) unless your||
5081|072|H|doctor directs you otherwise. Do not lie down for at least 10||
5081|073|H|minutes after taking this medication. If you have nausea, you may||
5081|074|H|take this medication with food. Ask your doctor or pharmacist||
5081|075|H|about other ways to decrease nausea (such as lying down for 1-2||
5081|076|H|hours with as little head movement as possible).||
5081|077|H|   The dosage is based on your medical condition, age, and||
5081|078|H|response to treatment. This medication works best if it is used||
5081|079|H|as the first signs of a headache occur. If you wait until the||
5081|080|H|headache has worsened, the medication may not work as well.||
5081|081|H|   Do not increase your dose or use this drug more often or for||
5081|082|H|longer than prescribed, because your risk of side effects may||
5081|083|H|increase. Properly stop the medication when so directed.||
5081|084|H|   Suddenly stopping this medication may cause withdrawal,||
5081|085|H|especially if you have used it for a long time or in high doses.||
5081|086|H|To prevent withdrawal, your doctor may lower your dose slowly.||
5081|087|H|Tell your doctor or pharmacist right away if you have any||
5081|088|H|withdrawal symptoms such as restlessness, mental/mood changes||
5081|089|H|(including anxiety, trouble sleeping, thoughts of suicide),||
5081|090|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
5081|091|H|aches, or sudden changes in behavior.||
5081|092|H|   Though it helps many people, this medication may sometimes||
5081|093|H|cause addiction. This risk may be higher if you have a||
5081|094|H|mental/mood disorder or a substance use disorder (such as overuse||
5081|095|H|of or addiction to drugs/alcohol). Take this medication exactly||
5081|096|H|as prescribed to lower the risk of addiction. Ask your doctor or||
5081|097|H|pharmacist for more details.||
5081|098|H|   Tell your doctor if you notice increased use of this||
5081|099|H|medication, a worsening of headaches, an increase in the number||
5081|100|H|of headaches, the medication not working as well, use of this||
5081|101|H|medication for more than 2 headache episodes a week, or if you||
5081|102|H|have any new pain. Your doctor may need to change your medication||
5081|103|H|and/or add a separate medication to prevent the headaches.||
5081|104|B|||
5081|105|S|SIDE EFFECTS:  See also Warning section.||
5081|106|S|   Nausea, vomiting, stomach upset, gas, shaking (tremor),||
5081|107|S|constipation, dry mouth, lightheadedness, dizziness, drowsiness,||
5081|108|S|or trouble sleeping may occur. If any of these effects last or||
5081|109|S|get worse, notify your doctor or pharmacist promptly.||
5081|110|S|   To reduce the risk of dizziness and lightheadedness, get up||
5081|111|S|slowly when rising from a sitting or lying position.||
5081|112|S|   To prevent constipation, eat dietary fiber, drink enough||
5081|113|S|water, and exercise. You may also need to take a laxative. Ask||
5081|114|S|your pharmacist which type of laxative is right for you.||
5081|115|S|   Remember that this medication has been prescribed because your||
5081|116|S|doctor has judged that the benefit to you is greater than the||
5081|117|S|risk of side effects. Many people using this medication do not||
5081|118|S|have serious side effects.||
5081|119|S|   Tell your doctor right away if you have any serious side||
5081|120|S|effects, including: interrupted breathing during sleep (sleep||
5081|121|S|apnea), mental/mood changes, fast/irregular heartbeat, increased||
5081|122|S|thirst/urination, hearing changes (such as ringing in the ears),||
5081|123|S|easy bruising/bleeding, heartburn, discomfort when swallowing,||
5081|124|S|dark urine, yellowing eyes/skin, signs of kidney problems (such||
5081|125|S|as change in the amount of urine), signs of your adrenal glands||
5081|126|S|not working well (such as loss of appetite, unusual tiredness,||
5081|127|S|weight loss).||
5081|128|S|   Get medical help right away if you have any very serious side||
5081|129|S|effects, including: fainting, seizure, black stools, severe||
5081|130|S|stomach/abdominal pain, vomit that looks like coffee grounds,||
5081|131|S|trouble speaking, weakness on one side of the body.||
5081|132|S|   Codeine is changed into a strong opioid drug (morphine) in||
5081|133|S|your body. In some people, this change happens faster and more||
5081|134|S|completely than usual, which increases the risk of very serious||
5081|135|S|side effects. Get medical help right away if you notice any of||
5081|136|S|the following: slow/shallow breathing, severe||
5081|137|S|drowsiness/difficulty waking up, confusion.||
5081|138|S|   A very serious allergic reaction to this drug is rare.||
5081|139|S|However, get medical help right away if you notice any symptoms||
5081|140|S|of a serious allergic reaction, including: fever, swollen lymph||
5081|141|S|nodes, rash, itching/swelling (especially of the||
5081|142|S|face/tongue/throat), severe dizziness, trouble breathing.||
5081|143|S|   This is not a complete list of possible side effects. If you||
5081|144|S|notice other effects not listed above, contact your doctor or||
5081|145|S|pharmacist.||
5081|146|S|   In the US -||
5081|147|S|   Call your doctor for medical advice about side effects. You||
5081|148|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5081|149|S|www.fda.gov/medwatch.||
5081|150|S|   In Canada - Call your doctor for medical advice about side||
5081|151|S|effects. You may report side effects to Health Canada at||
5081|152|S|1-866-234-2345.||
5081|153|B|||
5081|154|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
5081|155|P|pharmacist if you are allergic to aspirin, caffeine, codeine, or||
5081|156|P|butalbital; or to other barbiturates (such as phenobarbital),||
5081|157|P|salicylates (such as salsalate), nonsteroidal anti-inflammatory||
5081|158|P|drugs (such as ibuprofen), opioid pain medications (such as||
5081|159|P|morphine) or xanthine derivatives (such as theophylline); or if||
5081|160|P|you have any other allergies. This product may contain inactive||
5081|161|P|ingredients, which can cause allergic reactions or other||
5081|162|P|problems. Talk to your pharmacist for more details.||
5081|163|P|   Before using this medication, tell your doctor or pharmacist||
5081|164|P|your medical history, especially of: asthma (including a history||
5081|165|P|of worsening breathing with runny/stuffy nose after taking||
5081|166|P|aspirin or other NSAIDs), brain disorders (such as seizures, head||
5081|167|P|injury, tumor, increased intracranial pressure), breathing||
5081|168|P|problems (such as chronic obstructive pulmonary disease-COPD,||
5081|169|P|sleep apnea), bleeding/blood clotting disorders (such as||
5081|170|P|hemophilia, von Willebrand's disease, thrombocytopenia), a||
5081|171|P|certain enzyme disorder (porphyria), disease of the pancreas||
5081|172|P|(such as pancreatitis), heart disease (such as irregular||
5081|173|P|heartbeat, recent heart attack), certain enzyme deficiencies||
5081|174|P|(pyruvate kinase or G6-PD deficiency), gout, liver disease,||
5081|175|P|kidney disease, heartburn, growths in the nose (nasal polyps), a||
5081|176|P|certain spinal problem (kyphoscoliosis), gallbladder disease,||
5081|177|P|personal or family history of a substance use disorder (such as||
5081|178|P|overuse of or addiction to drugs/alcohol), mental/mood disorders,||
5081|179|P|stomach/intestinal problems (such as stomach/intestinal ulcers,||
5081|180|P|infectious diarrhea, colitis), adrenal gland problem (such as||
5081|181|P|Addison's disease), difficulty urinating (such as due to enlarged||
5081|182|P|prostate or urethral stricture), underactive thyroid||
5081|183|P|(hypothyroidism), recent bowel/abdominal surgery, obesity.||
5081|184|P|   Before having surgery or certain medical procedures (such as a||
5081|185|P|heart stress test or a procedure to restore a normal heart rhythm||
5081|186|P|if you have an unusually fast heartbeat), tell your doctor or||
5081|187|P|dentist that you use this medication and about all the products||
5081|188|P|you use (including prescription drugs, nonprescription drugs, and||
5081|189|P|herbal products).||
5081|190|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5081|191|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5081|192|P|machinery, or do anything that needs alertness until you can do||
5081|193|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5081|194|P|are using marijuana (cannabis).||
5081|195|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
5081|196|P|and tobacco, especially when combined with this medicine, may||
5081|197|P|increase your risk for stomach bleeding. Avoid alcohol and stop||
5081|198|P|smoking. Consult your doctor or pharmacist for more information.||
5081|199|P|   This medication contains aspirin. Children and teenagers less||
5081|200|P|than 18 years old should not take aspirin if they have||
5081|201|P|chickenpox, flu, or any undiagnosed illness, or if they have just||
5081|202|P|been given a live virus vaccine, without first consulting a||
5081|203|P|doctor about Reye's syndrome, a rare but serious illness.||
5081|204|P|   Older adults may be more sensitive to the side effects of this||
5081|205|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
5081|206|P|breathing, stomach/intestinal bleeding and ulcers, and trouble||
5081|207|P|falling asleep. Confusion, dizziness, drowsiness and trouble||
5081|208|P|falling asleep can increase the risk of falling.||
5081|209|P|   Before using this medication, women of childbearing age should||
5081|210|P|talk with their doctor(s) about the benefits and risks. Tell your||
5081|211|P|doctor if you are pregnant or if you plan to become pregnant.||
5081|212|P|This medication may harm an unborn baby and cause problems with||
5081|213|P|normal labor/delivery. It is not recommended for use in pregnancy||
5081|214|P|from 20 weeks until delivery. If your doctor decides that you||
5081|215|P|need to use this medication between 20 and 30 weeks of pregnancy,||
5081|216|P|you should use the lowest effective dose for the shortest||
5081|217|P|possible time. You should not use this medication after 30 weeks||
5081|218|P|of pregnancy.||
5081|219|P|   This drug passes into breast milk and could have undesirable||
5081|220|P|effects on a nursing infant. Breastfeeding is not recommended||
5081|221|P|while using this drug. Consult your doctor before breastfeeding.||
5081|222|B|||
5081|223|I|DRUG INTERACTIONS:  See also Warning section.||
5081|224|I|   Drug interactions may change how your medications work or||
5081|225|I|increase your risk for serious side effects. This document does||
5081|226|I|not contain all possible drug interactions. Keep a list of all||
5081|227|I|the products you use (including prescription/nonprescription||
5081|228|I|drugs and herbal products) and share it with your doctor and||
5081|229|I|pharmacist. Do not start, stop, or change the dosage of any||
5081|230|I|medicines without your doctor's approval.||
5081|231|I|   Some products that may interact with this drug include:||
5081|232|I|acetazolamide, antacids, certain antibiotics (including||
5081|233|I|penicillin, sulfonamides such as sulfamethoxazole), certain drugs||
5081|234|I|used to treat gout (including uricosuric drugs such as||
5081|235|I|probenecid), darunavir, dichlorphenamide, lithium,||
5081|236|I|6-mercaptopurine, methotrexate, methoxyflurane, mifepristone,||
5081|237|I|naltrexone, other medications for pain (such as morphine,||
5081|238|I|nalbuphine, pentazocine), samidorphan, sodium oxybate.||
5081|239|I|   This medication may increase the risk of bleeding when taken||
5081|240|I|with other drugs that also may cause bleeding. Examples include||
5081|241|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
5081|242|I|dabigatran/enoxaparin/warfarin, among others.||
5081|243|I|   This drug can speed up the removal of other drugs from your||
5081|244|I|body, which may affect how they work. Examples of affected drugs||
5081|245|I|include doxycycline, estrogen, felodipine, lonafarnib, quinidine,||
5081|246|I|rilpivirine, tamoxifen, theophylline, certain beta blockers (such||
5081|247|I|as metoprolol), corticosteroids (such as prednisone), among||
5081|248|I|others.||
5081|249|I|   The risk of serious side effects (such as slow/shallow||
5081|250|I|breathing, severe drowsiness/dizziness) may be increased if this||
5081|251|I|medication is taken with other products that may also cause||
5081|252|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5081|253|I|if you are taking other products such as other opioid pain or||
5081|254|I|cough relievers (such as morphine, hydrocodone), alcohol,||
5081|255|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
5081|256|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
5081|257|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
5081|258|I|cetirizine, diphenhydramine).||
5081|259|I|   Check the labels on all your medicines (such as allergy or||
5081|260|I|cough-and-cold products, other headache medications) because they||
5081|261|I|may contain aspirin, caffeine or ingredients that cause||
5081|262|I|drowsiness. Certain beverages (such as coffee, colas, tea) may||
5081|263|I|also contain caffeine. Ask your pharmacist about using those||
5081|264|I|products safely.||
5081|265|I|   Check all prescription and nonprescription medicine labels||
5081|266|I|carefully since many medications contain pain relievers/fever||
5081|267|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
5081|268|I|naproxen). These drugs are similar to this medication and may||
5081|269|I|increase your risk of side effects if taken together. Ask your||
5081|270|I|doctor or pharmacist for more details.||
5081|271|I|   Other medications can affect the removal of this product from||
5081|272|I|your body, which may affect how this product works. Examples||
5081|273|I|include azole antifungals (such as ketoconazole), bupropion,||
5081|274|I|fluoxetine, macrolide antibiotics (such as erythromycin), HIV||
5081|275|I|medications (such as ritonavir), paroxetine, rifamycins (such as||
5081|276|I|rifabutin, rifampin), certain drugs used to treat seizures (such||
5081|277|I|as carbamazepine, phenytoin), among others.||
5081|278|I|   This medication may decrease the effectiveness of hormonal||
5081|279|I|birth control such as pills, patch, or ring. This could cause||
5081|280|I|pregnancy. Discuss with your doctor or pharmacist if you should||
5081|281|I|use reliable backup birth control methods while using this||
5081|282|I|medication. Also tell your doctor if you have any new spotting or||
5081|283|I|breakthrough bleeding, because these may be signs that your birth||
5081|284|I|control is not working well.||
5081|285|I|   This medication may interfere with certain medical/lab tests||
5081|286|I|(such as fasting blood glucose, cholesterol levels, prothrombin||
5081|287|I|time, urine 5-HIAA levels, amylase and lipase levels, certain||
5081|288|I|urine glucose tests, dipyridamole-thallium imaging tests),||
5081|289|I|possibly causing false test results. Make sure lab personnel and||
5081|290|I|all your doctors know you use this drug.||
5081|291|B|||
5081|292|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5081|293|O|as passing out or trouble breathing, give them naloxone or||
5081|294|O|nalmefene if available, then call 911. If the person is awake and||
5081|295|O|has no symptoms, call a poison control center right away. US||
5081|296|O|residents can call 1-800-222-1222. Canada residents can call||
5081|297|O|1-844-764-7669. Symptoms of overdose may include: nausea/vomiting||
5081|298|O|that doesn't stop, severe drowsiness, slow/shallow breathing,||
5081|299|O|very small pupils, severe dizziness, ringing in the ears, coma.||
5081|300|B|||
5081|301|N|NOTES:  Do not share this medication with others. Sharing it is||
5081|302|N|against the law.||
5081|303|N|   Massage, hot baths, and other relaxation methods can help with||
5081|304|N|tension headaches. Consult your doctor or pharmacist for more||
5081|305|N|details.||
5081|306|N|   Lab and/or medical tests (such as liver/kidney function) may||
5081|307|N|be done while you are taking this medication. Keep all medical||
5081|308|N|and lab appointments. Consult your doctor for more details.||
5081|309|B|||
5081|310|D|MISSED DOSE:  Not applicable.||
5081|311|B|||
5081|312|R|STORAGE:  Store at room temperature away from light and moisture.||
5081|313|R|Do not store in the bathroom. Keep all medications away from||
5081|314|R|children and pets.||
5081|315|R|   Do not flush medications down the toilet or pour them into a||
5081|316|R|drain unless instructed to do so. Properly discard this product||
5081|317|R|when it is expired or no longer needed. Consult your pharmacist||
5081|318|R|or local waste disposal company.||
5081|319|B|||
5081|320|A|Information last revised August 2025.||
5081|321|A|Copyright(c) 2025 First Databank, Inc.||
5081|322|B|||
5083|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5083|002|Z|does NOT have all possible information about this product. This||
5083|003|Z|information does not assure that this product is safe, effective,||
5083|004|Z|or appropriate for you. This information is not individual||
5083|005|Z|medical advice and does not substitute for the advice of your||
5083|006|Z|health care professional. Always ask your health care||
5083|007|Z|professional for complete information about this product and your||
5083|008|Z|specific health needs.||
5083|009|B|||
5083|010|T|CROMOLYN - OPHTHALMIC||
5083|011|F|(CROW-mow-lin)||
5083|012|B|||
5083|013|C|COMMON BRAND NAME(S): Opticrom||
5083|014|B|||
5083|015|U|USES:  This medication is used to treat certain allergic eye||
5083|016|U|conditions (vernal keratoconjunctivitis, vernal conjunctivitis,||
5083|017|U|vernal keratitis). It prevents itching of the eyes that can occur||
5083|018|U|with these conditions. Cromolyn is known as a mast cell||
5083|019|U|stabilizer. It works by blocking certain natural substances||
5083|020|U|(histamine, SRS-A) that cause allergic symptoms.||
5083|021|B|||
5083|022|V|OTHER USES:  This section contains uses of this drug that are not||
5083|023|V|listed in the approved professional labeling for the drug but||
5083|024|V|that may be prescribed by your health care professional. Use this||
5083|025|V|drug for a condition that is listed in this section only if it||
5083|026|V|has been so prescribed by your health care professional.||
5083|027|V|   This drug may also be used for other eye conditions (such as||
5083|028|V|allergic conjunctivitis, giant papillary conjunctivitis).||
5083|029|B|||
5083|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5083|031|H|from your pharmacist before you start using cromolyn and each||
5083|032|H|time you get a refill. If you have any questions, ask your doctor||
5083|033|H|or pharmacist.||
5083|034|H|   Use this medication in the affected eye(s) as directed by your||
5083|035|H|doctor, usually 4 times daily. Treatment may be continued for as||
5083|036|H|long as 3 months.||
5083|037|H|   To apply eye drops, wash your hands first. To avoid||
5083|038|H|contamination, do not touch the dropper tip or let it touch your||
5083|039|H|eye or any other surface.||
5083|040|H|   It is best to avoid wearing contact lenses while using this||
5083|041|H|medication.||
5083|042|H|   Tilt your head back, look upward, and pull down the lower||
5083|043|H|eyelid to make a pouch. Hold the dropper directly over the eye||
5083|044|H|and place 1 drop into the pouch. Look downward and gently close||
5083|045|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
5083|046|H|the eye near the nose and apply gentle pressure. This will||
5083|047|H|prevent the medication from draining away from the eye. Try not||
5083|048|H|to blink and do not rub the eye. Repeat these steps if your dose||
5083|049|H|is for more than 1 drop and for the other eye if so directed.||
5083|050|H|   Do not rinse the dropper. Replace the dropper cap tightly||
5083|051|H|after each use.||
5083|052|H|   If you are using another kind of eye medication (such as drops||
5083|053|H|or ointments), wait at least 5 minutes before applying other||
5083|054|H|medications. Use eye drops before eye ointments to allow the eye||
5083|055|H|drops to enter the eye.||
5083|056|H|   Wait several minutes for your vision to clear before driving||
5083|057|H|or operating machinery.||
5083|058|H|   Use this medication regularly in order to get the most benefit||
5083|059|H|from it. To help you remember, use it at the same times each day.||
5083|060|H|Keep using it for the full time prescribed.||
5083|061|H|   It may take up to several days of continued use to see a||
5083|062|H|relief in symptoms and up to 6 weeks for full benefit. If||
5083|063|H|immediate relief of symptoms (itching) is needed, use other||
5083|064|H|quick-relief medication (such as eye drops containing||
5083|065|H|antihistamines, decongestants, or nonsteroidal anti-inflammatory||
5083|066|H|drugs-NSAIDs) along with cromolyn as directed by your doctor.||
5083|067|H|Tell your doctor if your condition lasts or gets worse.||
5083|068|B|||
5083|069|S|SIDE EFFECTS:  Burning or stinging of the eye may occur. If any||
5083|070|S|of these effects last or get worse, tell your doctor or||
5083|071|S|pharmacist promptly.||
5083|072|S|   Remember that this medication has been prescribed because your||
5083|073|S|doctor has judged that the benefit to you is greater than the||
5083|074|S|risk of side effects. Many people using this medication do not||
5083|075|S|have serious side effects.||
5083|076|S|   A very serious allergic reaction to this drug is rare.||
5083|077|S|However, get medical help right away if you notice any symptoms||
5083|078|S|of a serious allergic reaction, including: rash, itching/swelling||
5083|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5083|080|S|breathing.||
5083|081|S|   This is not a complete list of possible side effects. If you||
5083|082|S|notice other effects not listed above, contact your doctor or||
5083|083|S|pharmacist.||
5083|084|S|   In the US -||
5083|085|S|   Call your doctor for medical advice about side effects. You||
5083|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5083|087|S|www.fda.gov/medwatch.||
5083|088|S|   In Canada - Call your doctor for medical advice about side||
5083|089|S|effects. You may report side effects to Health Canada at||
5083|090|S|1-866-234-2345.||
5083|091|B|||
5083|092|P|PRECAUTIONS:  Before using cromolyn, tell your doctor or||
5083|093|P|pharmacist if you are allergic to it; or if you have any other||
5083|094|P|allergies. This product may contain inactive ingredients (such as||
5083|095|P|preservatives like benzalkonium chloride), which can cause||
5083|096|P|allergic reactions or other problems. Talk to your pharmacist for||
5083|097|P|more details.||
5083|098|P|   Before using this medication, tell your doctor or pharmacist||
5083|099|P|your medical history, especially of: contact lens use.||
5083|100|P|   After you apply this drug, your vision may become temporarily||
5083|101|P|blurred. Do not drive, use machinery, or do anything that needs||
5083|102|P|clear vision until you can do it safely.||
5083|103|P|   Before having surgery, tell your doctor or dentist about all||
5083|104|P|the products you use (including prescription drugs,||
5083|105|P|nonprescription drugs, and herbal products).||
5083|106|P|   During pregnancy, this medication should be used only when||
5083|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
5083|108|P|   It is unknown if this drug passes into breast milk. Consult||
5083|109|P|your doctor before breastfeeding.||
5083|110|B|||
5083|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5083|112|I|medications work or increase your risk for serious side effects.||
5083|113|I|This document does not contain all possible drug interactions.||
5083|114|I|Keep a list of all the products you use (including||
5083|115|I|prescription/nonprescription drugs and herbal products) and share||
5083|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
5083|117|I|the dosage of any medicines without your doctor's approval.||
5083|118|B|||
5083|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5083|120|O|has overdosed and has serious symptoms such as passing out or||
5083|121|O|trouble breathing, call 911. Otherwise, call a poison control||
5083|122|O|center right away. US residents can call 1-800-222-1222. Canada||
5083|123|O|residents can call 1-844-764-7669.||
5083|124|B|||
5083|125|N|NOTES:  Avoid allergens that may be the cause of your allergies.||
5083|126|N|Some common allergens that cause allergic eye conditions include||
5083|127|N|pollen, grasses, weeds, dust mites, and pet dander.||
5083|128|N|   Do not share this medication with others.||
5083|129|N|   This medication has been prescribed for your current condition||
5083|130|N|only. Do not use it later for another condition unless directed||
5083|131|N|to do so by your doctor. A different medication may be necessary||
5083|132|N|in that case.||
5083|133|B|||
5083|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5083|135|D|If it is near the time of the next dose, skip the missed dose.||
5083|136|D|Use your next dose at the regular time. Do not double the dose to||
5083|137|D|catch up.||
5083|138|B|||
5083|139|R|STORAGE:  Store dropper bottle upright at room temperature away||
5083|140|R|from light. Discard any remaining solution after 4 weeks if||
5083|141|R|directed to do so by the product manufacturer. Keep all||
5083|142|R|medications away from children and pets.||
5083|143|R|   Do not flush medications down the toilet or pour them into a||
5083|144|R|drain unless instructed to do so. Properly discard this product||
5083|145|R|when it is expired or no longer needed. Consult your pharmacist||
5083|146|R|or local waste disposal company.||
5083|147|B|||
5083|148|A|Information last revised May 2024.||
5083|149|A|Copyright(c) 2025 First Databank, Inc.||
5083|150|B|||
5084|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5084|002|Z|does NOT have all possible information about this product. This||
5084|003|Z|information does not assure that this product is safe, effective,||
5084|004|Z|or appropriate for you. This information is not individual||
5084|005|Z|medical advice and does not substitute for the advice of your||
5084|006|Z|health care professional. Always ask your health care||
5084|007|Z|professional for complete information about this product and your||
5084|008|Z|specific health needs.||
5084|009|B|||
5084|010|T|ASPIRIN/DIPYRIDAMOLE SUSTAINED-RELEASE - ORAL||
5084|011|F|(AS-pir-in/DYE-pir-ID-a-mole)||
5084|012|B|||
5084|013|C|COMMON BRAND NAME(S): Aggrenox||
5084|014|B|||
5084|015|U|USES:  This medication is used to reduce the risk of stroke in||
5084|016|U|patients who have had "mini-strokes" (transient ischemic attacks)||
5084|017|U|or a previous stroke due to a blood clot and are at high risk for||
5084|018|U|another stroke. It contains two medications: a very low dose of||
5084|019|U|aspirin (25 milligrams per tablet) and dipyridamole in a||
5084|020|U|slow-release form.||
5084|021|U|   Low-dose aspirin and dipyridamole are antiplatelet drugs that||
5084|022|U|work to keep blood flowing to the brain by stopping platelets||
5084|023|U|from clumping together. This helps prevent the platelets from||
5084|024|U|forming blood clots, which can lodge in the brain and cause a||
5084|025|U|certain type of stroke (ischemic stroke).||
5084|026|B|||
5084|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5084|028|H|from your pharmacist before you start taking this product and||
5084|029|H|each time you get a refill. If you have any questions, ask your||
5084|030|H|doctor or pharmacist.||
5084|031|H|   Take this medication by mouth with or without food as directed||
5084|032|H|by your doctor, usually twice daily (morning and evening).||
5084|033|H|Swallow the capsule whole. Do not crush or chew the capsules.||
5084|034|H|Doing so can release all of the drug at once, increasing the risk||
5084|035|H|of side effects.||
5084|036|H|   Take this medication with a full glass of water (8 ounces or||
5084|037|H|240 milliliters) unless your doctor directs you otherwise.||
5084|038|H|   The dosage is based on your medical condition and response to||
5084|039|H|treatment. If you have certain side effects (such as severe||
5084|040|H|headache) when you first start taking this medication, your||
5084|041|H|doctor may temporarily change your dose. Carefully follow your||
5084|042|H|doctor's directions. Use this medication regularly to get the||
5084|043|H|most benefit from it. To help you remember, take it at the same||
5084|044|H|times each day.||
5084|045|H|   Do not try to replace this combination medication with aspirin||
5084|046|H|and dipyridamole taken separately. You would not be able to get||
5084|047|H|the right dose and slow-release dosage form, so the separate||
5084|048|H|medications would not work as well as this combination||
5084|049|H|medication. Consult your pharmacist for more information.||
5084|050|B|||
5084|051|S|SIDE EFFECTS:  Headache, nausea, vomiting, diarrhea, abdominal||
5084|052|S|pain, heartburn, and dizziness may occur. Talk with your doctor||
5084|053|S|if you have a severe headache when you first start taking this||
5084|054|S|medication. Your doctor may change your dose for the first week||
5084|055|S|to lessen headache (see also How to Use section). If any of these||
5084|056|S|effects last or get worse, tell your doctor or pharmacist||
5084|057|S|promptly.||
5084|058|S|   To reduce the risk of dizziness and lightheadedness, get up||
5084|059|S|slowly when rising from a sitting or lying position.||
5084|060|S|   Remember that this medication has been prescribed because your||
5084|061|S|doctor has judged that the benefit to you is greater than the||
5084|062|S|risk of side effects. Many people using this medication do not||
5084|063|S|have serious side effects.||
5084|064|S|   Tell your doctor right away if you have any serious side||
5084|065|S|effects, including: easy bleeding/bruising, uncontrolled bleeding||
5084|066|S|from gums or nose, fast/slow/irregular heartbeat, loss of||
5084|067|S|appetite, dark urine, yellowing eyes/skin, unusual tiredness,||
5084|068|S|unusual weakness, signs of kidney problems (such as change in the||
5084|069|S|amount of urine).||
5084|070|S|   This drug may rarely cause serious bleeding from the stomach||
5084|071|S|or intestines. If you notice any of the following serious side||
5084|072|S|effects, stop taking this medication and consult your doctor or||
5084|073|S|pharmacist right away: stomach/abdominal pain that doesn't go||
5084|074|S|away, black stools, vomit that looks like coffee grounds.||
5084|075|S|   Get medical help right away if you have any very serious side||
5084|076|S|effects, including: fainting, symptoms of a heart attack (such as||
5084|077|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
5084|078|S|signs of bleeding in the brain or stroke (such as weakness on one||
5084|079|S|side of the body, trouble speaking, sudden vision changes,||
5084|080|S|confusion).||
5084|081|S|   A very serious allergic reaction to this drug is rare.||
5084|082|S|However, get medical help right away if you notice any symptoms||
5084|083|S|of a serious allergic reaction, including: fever, swollen lymph||
5084|084|S|nodes, rash, itching/swelling (especially of the||
5084|085|S|face/tongue/throat), severe dizziness, trouble breathing.||
5084|086|S|   This is not a complete list of possible side effects. If you||
5084|087|S|notice other effects not listed above, contact your doctor or||
5084|088|S|pharmacist.||
5084|089|S|   In the US -||
5084|090|S|   Call your doctor for medical advice about side effects. You||
5084|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5084|092|S|www.fda.gov/medwatch.||
5084|093|S|   In Canada - Call your doctor for medical advice about side||
5084|094|S|effects. You may report side effects to Health Canada at||
5084|095|S|1-866-234-2345.||
5084|096|B|||
5084|097|P|PRECAUTIONS:  Before taking this medication, tell your doctor if||
5084|098|P|you are allergic to dipyridamole; or to aspirin; or to other||
5084|099|P|salicylates (such as choline salicylate); or to NSAIDs (such as||
5084|100|P|ibuprofen, naproxen); or if you have any other allergies. This||
5084|101|P|product may contain inactive ingredients, which can cause||
5084|102|P|allergic reactions or other problems. Talk to your pharmacist for||
5084|103|P|more details.||
5084|104|P|   Before using this medication, tell your doctor or pharmacist||
5084|105|P|your medical history, especially of: asthma (including a history||
5084|106|P|of worsening breathing after taking aspirin or other NSAIDs),||
5084|107|P|bleeding problems (such as hemophilia, vitamin K deficiency, low||
5084|108|P|platelets), low blood pressure (hypotension), heart problems||
5084|109|P|(such as angina, heart attack), stomach problems (such as ulcers,||
5084|110|P|heartburn), kidney disease, liver disease, a certain muscle||
5084|111|P|problem (myasthenia gravis), growths in the nose (nasal polyps),||
5084|112|P|bleeding in the brain.||
5084|113|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5084|114|P|can make you more dizzy. Do not drive, use machinery, or do||
5084|115|P|anything that needs alertness until you can do it safely. Talk to||
5084|116|P|your doctor if you are using marijuana (cannabis).||
5084|117|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
5084|118|P|and tobacco while using this medicine may increase your risk for||
5084|119|P|stomach bleeding. Limit alcohol and stop smoking. Ask your doctor||
5084|120|P|or pharmacist about how much alcohol you may safely drink.||
5084|121|P|   Before having surgery, tell your doctor or dentist about all||
5084|122|P|the products you use (including prescription drugs,||
5084|123|P|nonprescription drugs, and herbal products). Your doctor may||
5084|124|P|instruct you to stop aspirin/dipyridamole 10 days before surgery.||
5084|125|P|Do not stop taking this medication without first talking with the||
5084|126|P|doctor who prescribed it.||
5084|127|P|   The amount of aspirin in this medication may not be enough to||
5084|128|P|prevent heart attack. If you need aspirin to prevent heart||
5084|129|P|attack, consult your doctor or pharmacist for more information.||
5084|130|P|   This drug contains aspirin. Children and teenagers younger||
5084|131|P|than 18 should not take aspirin if they have chickenpox, flu, or||
5084|132|P|any undiagnosed illness or if they have recently received a||
5084|133|P|vaccine. In these cases, taking aspirin increases the risk of||
5084|134|P|Reye's syndrome, a rare but serious illness.||
5084|135|P|   Older adults may be more sensitive to the side effects of this||
5084|136|P|drug, especially dizziness and bleeding.||
5084|137|P|   During pregnancy, this medication should be used only when||
5084|138|P|clearly needed. Discuss the risks and benefits with your doctor.||
5084|139|P|   Aspirin and dipyridamole pass into breast milk. Consult your||
5084|140|P|doctor before breastfeeding.||
5084|141|B|||
5084|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5084|143|I|medications work or increase your risk for serious side effects.||
5084|144|I|This document does not contain all possible drug interactions.||
5084|145|I|Keep a list of all the products you use (including||
5084|146|I|prescription/nonprescription drugs and herbal products) and share||
5084|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
5084|148|I|the dosage of any medicines without your doctor's approval.||
5084|149|I|   Some products that may interact with this drug include:||
5084|150|I|corticosteroids (such as prednisone), mifepristone, ginkgo||
5084|151|I|biloba, other drugs that can cause bleeding/bruising (including||
5084|152|I|antiplatelet drugs such as clopidogrel, NSAIDs such as||
5084|153|I|ibuprofen/naproxen, "blood thinners" such as||
5084|154|I|warfarin/dabigatran), riociguat.||
5084|155|I|   Check all prescription and nonprescription medicine labels||
5084|156|I|carefully since many medications contain pain relievers/fever||
5084|157|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
5084|158|I|naproxen). These drugs are similar to this medication and may||
5084|159|I|increase your risk of side effects if taken together. However, if||
5084|160|I|your doctor has told you to take low-dose aspirin to prevent||
5084|161|I|heart attack (usually 81-162 milligrams a day), ask your doctor||
5084|162|I|if you should keep taking the aspirin. The low dose of aspirin in||
5084|163|I|this product may not be enough to protect against heart attack.||
5084|164|I|Ask your doctor or pharmacist for more details.||
5084|165|I|   This medication may interfere with certain medical/lab tests||
5084|166|I|(such as chemical stress tests using adenosine/dipyridamole),||
5084|167|I|possibly causing false test results. Make sure lab personnel and||
5084|168|I|all your doctors know you use this drug.||
5084|169|B|||
5084|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5084|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5084|172|O|poison control center right away. US residents can call||
5084|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5084|174|O|Symptoms of overdose may include: ringing in the ears, flushing,||
5084|175|O|sweating, restlessness, weakness, dizziness, fast heartbeat.||
5084|176|B|||
5084|177|N|NOTES:  Do not share this medication with others.||
5084|178|B|||
5084|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5084|180|D|remember. If it is near the time of the next dose, skip the||
5084|181|D|missed dose. Take your next dose at the regular time. Do not||
5084|182|D|double the dose to catch up.||
5084|183|B|||
5084|184|R|STORAGE:  Store at room temperature away from light and moisture.||
5084|185|R|Do not store in the bathroom. Keep all medications away from||
5084|186|R|children and pets.||
5084|187|R|   Do not flush medications down the toilet or pour them into a||
5084|188|R|drain unless instructed to do so. Properly discard this product||
5084|189|R|when it is expired or no longer needed. Consult your pharmacist||
5084|190|R|or local waste disposal company.||
5084|191|B|||
5084|192|M|MEDICAL ALERT:  Your condition can cause complications in a||
5084|193|M|medical emergency. For information about enrolling in MedicAlert,||
5084|194|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5084|195|B|||
5084|196|A|Information last revised November 2025.||
5084|197|A|Copyright(c) 2025 First Databank, Inc.||
5084|198|B|||
5087|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5087|002|Z|does NOT have all possible information about this product. This||
5087|003|Z|information does not assure that this product is safe, effective,||
5087|004|Z|or appropriate for you. This information is not individual||
5087|005|Z|medical advice and does not substitute for the advice of your||
5087|006|Z|health care professional. Always ask your health care||
5087|007|Z|professional for complete information about this product and your||
5087|008|Z|specific health needs.||
5087|009|B|||
5087|010|T|ORPHENADRINE/ASPIRIN/CAFFEINE - ORAL||
5087|011|F|(or-FEN-a-dreen/AS-pir-in/KAF-een)||
5087|012|B|||
5087|013|C|COMMON BRAND NAME(S): Norgesic Forte||
5087|014|B|||
5087|015|U|USES:  This medication is a combination of orphenadrine, aspirin,||
5087|016|U|and caffeine. It is used to treat muscle pain. It is usually used||
5087|017|U|along with rest, physical therapy, and other treatment.||
5087|018|U|   Orphenadrine relieves muscle pain. Aspirin relieves pain and||
5087|019|U|decreases swelling. Caffeine may help increase the effects of||
5087|020|U|aspirin on pain.||
5087|021|B|||
5087|022|H|HOW TO USE:  Take this medication by mouth as directed by your||
5087|023|H|doctor. Do not increase your dose or use this drug more often or||
5087|024|H|for longer than prescribed. Your condition will not improve any||
5087|025|H|faster, and your risk of side effects will increase.||
5087|026|H|   If you have stomach upset while taking this medication, take||
5087|027|H|it with food or milk. Take this medication with a full glass of||
5087|028|H|water (8 ounces/240 milliliters) unless your doctor directs you||
5087|029|H|otherwise. Do not lie down for 10 minutes after taking this||
5087|030|H|medication.||
5087|031|H|   The dosage is based on your medical condition and response to||
5087|032|H|treatment. Use the smallest effective dose.||
5087|033|H|   This medication contains caffeine. Avoid drinking large||
5087|034|H|amounts of beverages containing caffeine (coffee, tea, colas),||
5087|035|H|eating large amounts of chocolate, or taking nonprescription||
5087|036|H|products that contain caffeine.||
5087|037|H|   Tell your doctor if your condition lasts or if it gets worse.||
5087|038|B|||
5087|039|S|SIDE EFFECTS:  Dry mouth, dizziness, drowsiness, lightheadedness,||
5087|040|S|blurred vision, upset stomach, heartburn, nausea, vomiting,||
5087|041|S|constipation, or trouble sleeping may occur. If any of these||
5087|042|S|effects last or get worse, tell your doctor or pharmacist||
5087|043|S|promptly.||
5087|044|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
5087|045|S|chips, chew (sugarless) gum, drink water, or use a saliva||
5087|046|S|substitute.||
5087|047|S|   Remember that this medication has been prescribed because your||
5087|048|S|doctor has judged that the benefit to you is greater than the||
5087|049|S|risk of side effects. Many people using this medication do not||
5087|050|S|have serious side effects.||
5087|051|S|   Tell your doctor right away if you have any serious side||
5087|052|S|effects, including: mental/mood changes (such as confusion,||
5087|053|S|anxiety, hallucinations, nervousness, agitation), shaking||
5087|054|S|(tremor), fast/pounding/irregular heartbeat, hearing changes||
5087|055|S|(such as ringing in the ears, difficulty hearing), difficulty||
5087|056|S|urinating, easy bleeding/bruising, fainting, eye pain, unusual||
5087|057|S|tiredness, signs of kidney problems (such as change in the amount||
5087|058|S|of urine), yellowing eyes/skin, dark urine.||
5087|059|S|   This drug may rarely cause serious bleeding from the stomach||
5087|060|S|or intestines. If you notice any of the following unlikely but||
5087|061|S|serious side effects, stop taking this medication and get medical||
5087|062|S|help right away: stomach/abdominal pain that doesn't go away,||
5087|063|S|black stools, vomit that looks like coffee grounds.||
5087|064|S|   A very serious allergic reaction to this drug is rare.||
5087|065|S|However, get medical help right away if you notice any symptoms||
5087|066|S|of a serious allergic reaction, including: fever, swollen lymph||
5087|067|S|nodes, rash, itching/swelling (especially of the||
5087|068|S|face/tongue/throat), severe dizziness, trouble breathing.||
5087|069|S|   This is not a complete list of possible side effects. If you||
5087|070|S|notice other effects not listed above, contact your doctor or||
5087|071|S|pharmacist.||
5087|072|S|   In the US -||
5087|073|S|   Call your doctor for medical advice about side effects. You||
5087|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5087|075|S|www.fda.gov/medwatch.||
5087|076|S|   In Canada - Call your doctor for medical advice about side||
5087|077|S|effects. You may report side effects to Health Canada at||
5087|078|S|1-866-234-2345.||
5087|079|B|||
5087|080|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
5087|081|P|pharmacist if you are allergic to orphenadrine, aspirin, or||
5087|082|P|caffeine; or to other nonsteroidal anti-inflammatory drugs-NSAIDs||
5087|083|P|(such as ibuprofen, naproxen, celecoxib); or to other salicylates||
5087|084|P|(such as choline salicylate); or if you have any other allergies.||
5087|085|P|This product may contain inactive ingredients, which can cause||
5087|086|P|allergic reactions or other problems. Talk to your pharmacist for||
5087|087|P|more details.||
5087|088|P|   Before using this medication, tell your doctor or pharmacist||
5087|089|P|your medical history, especially of: high pressure in the eye||
5087|090|P|(glaucoma), stomach/intestine/esophagus problems (such as ulcers,||
5087|091|P|blockage, difficulty swallowing, heartburn), difficulty urinating||
5087|092|P|(such as due to enlarged prostate), a certain type of||
5087|093|P|muscle/nerve disease (myasthenia gravis), asthma (including a||
5087|094|P|history of worsening breathing with runny/stuffy nose after||
5087|095|P|taking aspirin or other NSAIDs), growths in the nose (nasal||
5087|096|P|polyps), bleeding/blood clotting problems (such as hemophilia,||
5087|097|P|thrombocytopenia), gout, heart problems (such as fast/irregular||
5087|098|P|heartbeat, heart failure, heart attack), high blood pressure,||
5087|099|P|kidney disease, liver disease, mental/mood disorders (such as||
5087|100|P|anxiety, nervousness), certain enzyme deficiencies (such as||
5087|101|P|pyruvate kinase or G6PD deficiency).||
5087|102|P|   This drug may make you dizzy or drowsy or cause blurred||
5087|103|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
5087|104|P|or drowsy. Do not drive, use machinery, or do anything that needs||
5087|105|P|alertness or clear vision until you can do it safely. Limit||
5087|106|P|alcoholic beverages. Talk to your doctor if you are using||
5087|107|P|marijuana (cannabis).||
5087|108|P|   Before having surgery or certain medical procedures (such as a||
5087|109|P|heart stress test or a procedure to restore a normal heart rhythm||
5087|110|P|if you have an unusually fast heartbeat), tell your doctor or||
5087|111|P|dentist that you use this medication and about all the products||
5087|112|P|you use (including prescription drugs, nonprescription drugs, and||
5087|113|P|herbal products).||
5087|114|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
5087|115|P|and tobacco, especially when combined with this product, may||
5087|116|P|increase your risk for stomach bleeding. Limit alcoholic||
5087|117|P|beverages and stop smoking. Consult your doctor or pharmacist for||
5087|118|P|more information.||
5087|119|P|   This drug contains aspirin. Children and teenagers younger||
5087|120|P|than 18 years should not take aspirin if they have chickenpox,||
5087|121|P|flu, or any undiagnosed illness or if they have recently received||
5087|122|P|a vaccine. In these cases, taking aspirin increases the risk of||
5087|123|P|Reye's syndrome, a rare but serious illness.||
5087|124|P|   Older adults may be more sensitive to the side effects of this||
5087|125|P|drug, especially confusion, stomach ulcer/bleeding, constipation,||
5087|126|P|drowsiness, or trouble urinating. Confusion and drowsiness can||
5087|127|P|increase the risk of falling.||
5087|128|P|   Before using this medication, women of childbearing age should||
5087|129|P|talk with their doctor(s) about the benefits and risks. Tell your||
5087|130|P|doctor if you are pregnant or if you plan to become pregnant.||
5087|131|P|This medication may harm an unborn baby and cause problems with||
5087|132|P|normal labor/delivery. It is not recommended for use in pregnancy||
5087|133|P|from 20 weeks until delivery. If your doctor decides that you||
5087|134|P|need to use this medication between 20 and 30 weeks of pregnancy,||
5087|135|P|you should use the lowest effective dose for the shortest||
5087|136|P|possible time. You should not use this medication after 30 weeks||
5087|137|P|of pregnancy.||
5087|138|P|   This medication passes into breast milk and may harm a nursing||
5087|139|P|infant. Breastfeeding is not recommended while using this||
5087|140|P|medication. Consult your doctor before breastfeeding.||
5087|141|B|||
5087|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5087|143|I|medications work or increase your risk for serious side effects.||
5087|144|I|This document does not contain all possible drug interactions.||
5087|145|I|Keep a list of all the products you use (including||
5087|146|I|prescription/nonprescription drugs and herbal products) and share||
5087|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
5087|148|I|the dosage of any medicines without your doctor's approval.||
5087|149|I|   Some products that may interact with this drug are:||
5087|150|I|dichlorphenamide, methotrexate, mifepristone, vemurafenib.||
5087|151|I|   This medication may increase the risk of bleeding when taken||
5087|152|I|with other drugs that also may cause bleeding. Examples include||
5087|153|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
5087|154|I|dabigatran/enoxaparin/warfarin, among others.||
5087|155|I|   Check all prescription and nonprescription medicine labels||
5087|156|I|carefully since many medications contain pain relievers/fever||
5087|157|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
5087|158|I|naproxen). These drugs are similar to this medication and may||
5087|159|I|increase your risk of side effects if taken together. Ask your||
5087|160|I|doctor or pharmacist for more details.||
5087|161|I|   Tell your doctor or pharmacist if you are taking other||
5087|162|I|products that cause drowsiness such as opioid pain or cough||
5087|163|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5087|164|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5087|165|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5087|166|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5087|167|I|diphenhydramine).||
5087|168|I|   Check the labels on all your medicines (such as allergy or||
5087|169|I|cough-and-cold products) because they may contain ingredients||
5087|170|I|that cause drowsiness. Ask your pharmacist about using those||
5087|171|I|products safely.||
5087|172|I|   This medication may interfere with certain medical/lab tests||
5087|173|I|(such as dipyridamole-thallium imaging tests, certain urine||
5087|174|I|tests), possibly causing false test results. Make sure lab||
5087|175|I|personnel and all your doctors know you use this drug.||
5087|176|B|||
5087|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5087|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5087|179|O|poison control center right away. US residents can call||
5087|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5087|181|O|Symptoms of overdose may include: unusual excitement,||
5087|182|O|fast/irregular heartbeat, seizures, rapid breathing, mental/mood||
5087|183|O|changes (such as confusion), change in the amount of urine.||
5087|184|B|||
5087|185|N|NOTES:  Do not share this medication with others.||
5087|186|N|   This medication has been prescribed for your current condition||
5087|187|N|only. Do not use it later for another condition unless your||
5087|188|N|doctor tells you to. A different medication may be necessary in||
5087|189|N|that case.||
5087|190|N|   If you are taking this medication for a long time, lab and/or||
5087|191|N|medical tests (such as liver/kidney function, blood count) may be||
5087|192|N|done. Keep all medical and lab appointments. Consult your doctor||
5087|193|N|for more details.||
5087|194|B|||
5087|195|D|MISSED DOSE:  If you are taking this medication on a regular||
5087|196|D|schedule and miss a dose, take it as soon as you remember. If it||
5087|197|D|is near the time of the next dose, skip the missed dose. Take||
5087|198|D|your next dose at the regular time. Do not double the dose to||
5087|199|D|catch up.||
5087|200|B|||
5087|201|R|STORAGE:  Store at room temperature away from light and moisture.||
5087|202|R|Do not store in the bathroom. Keep all medications away from||
5087|203|R|children and pets.||
5087|204|R|   Do not flush medications down the toilet or pour them into a||
5087|205|R|drain unless instructed to do so. Properly discard this product||
5087|206|R|when it is expired or no longer needed. Consult your pharmacist||
5087|207|R|or local waste disposal company.||
5087|208|B|||
5087|209|A|Information last revised May 2024.||
5087|210|A|Copyright(c) 2025 First Databank, Inc.||
5087|211|B|||
5090|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5090|002|Z|does NOT have all possible information about this product. This||
5090|003|Z|information does not assure that this product is safe, effective,||
5090|004|Z|or appropriate for you. This information is not individual||
5090|005|Z|medical advice and does not substitute for the advice of your||
5090|006|Z|health care professional. Always ask your health care||
5090|007|Z|professional for complete information about this product and your||
5090|008|Z|specific health needs.||
5090|009|B|||
5090|010|T|METOCLOPRAMIDE - INJECTION||
5090|011|F|(MET-oh-KLOE-pra-mide)||
5090|012|B|||
5090|013|C|COMMON BRAND NAME(S): Reglan||
5090|014|B|||
5090|015|W|WARNING:  This medication may cause a serious movement disorder||
5090|016|W|called tardive dyskinesia. In some cases, this condition may be||
5090|017|W|permanent. The risk of tardive dyskinesia is increased with the||
5090|018|W|longer use of the medication and the more medication that you||
5090|019|W|receive. The risk is also increased in older adults (especially||
5090|020|W|women) and in people with diabetes. Metoclopramide comes in||
5090|021|W|different forms (such as tablets, solution). Do not use||
5090|022|W|metoclopramide products for longer than 12 weeks. Talk to your||
5090|023|W|doctor about the risks and benefits of this medication.||
5090|024|W|   Tell your doctor right away if you develop any unusual||
5090|025|W|uncontrolled movements (especially of the face, mouth, tongue,||
5090|026|W|arms or legs). There is no treatment for tardive dyskinesia, but||
5090|027|W|in some cases the symptoms may lessen or stop once metoclopramide||
5090|028|W|is stopped.||
5090|029|B|||
5090|030|U|USES:  Metoclopramide is used to prevent nausea and vomiting from||
5090|031|U|surgery or chemotherapy. It is also used by people with diabetes||
5090|032|U|who have slow emptying of their stomachs (gastroparesis).||
5090|033|U|Treating gastroparesis can decrease symptoms of nausea, vomiting,||
5090|034|U|and stomach/abdominal fullness. Metoclopramide may also be used||
5090|035|U|in certain procedures where stomach emptying is needed.||
5090|036|U|Metoclopramide works by blocking a natural substance (dopamine)||
5090|037|U|which can cause nausea and vomiting. It also speeds up stomach||
5090|038|U|emptying and movement of the upper intestines.||
5090|039|U|   This drug is not recommended for use in children younger than||
5090|040|U|1 year due to an increased risk of serious side effects (such as||
5090|041|U|muscle spasms/uncontrolled muscle movements). Ask the doctor or||
5090|042|U|pharmacist for details.||
5090|043|B|||
5090|044|H|HOW TO USE:  See also Warning section.||
5090|045|H|   Read the Medication Guide provided by your pharmacist before||
5090|046|H|you start using metoclopramide and each time you get a refill. If||
5090|047|H|you have any questions, ask your doctor or pharmacist.||
5090|048|H|   This medication is given by injection into a muscle or vein by||
5090|049|H|a health care professional.||
5090|050|H|   The dosage is based on your medical condition, response to||
5090|051|H|treatment, age, weight and other medications you may be taking.||
5090|052|H|Be sure to tell your doctor and pharmacist about all the products||
5090|053|H|you use (including prescription drugs, nonprescription drugs, and||
5090|054|H|herbal products).||
5090|055|H|   If you suddenly stop using this medication, you may have||
5090|056|H|withdrawal symptoms (such as dizziness, nervousness, headaches).||
5090|057|H|To help prevent withdrawal, your doctor may lower your dose||
5090|058|H|slowly. Withdrawal is more likely if you have used metoclopramide||
5090|059|H|for a long time or in high doses. Tell your doctor or pharmacist||
5090|060|H|right away if you have withdrawal.||
5090|061|H|   Tell your doctor right away if your condition lasts or gets||
5090|062|H|worse.||
5090|063|B|||
5090|064|S|SIDE EFFECTS:  See also Warning section.||
5090|065|S|   Drowsiness, dizziness, tiredness, trouble sleeping, headache,||
5090|066|S|flushing, or diarrhea may occur. If any of these effects last or||
5090|067|S|get worse, tell your doctor or pharmacist promptly.||
5090|068|S|   Remember that this medication has been prescribed because your||
5090|069|S|doctor has judged that the benefit to you is greater than the||
5090|070|S|risk of side effects. Many people using this medication do not||
5090|071|S|have serious side effects.||
5090|072|S|   This medication may raise your blood pressure. Check your||
5090|073|S|blood pressure regularly and tell your doctor if the results are||
5090|074|S|high.||
5090|075|S|   Tell your doctor right away if you have any serious side||
5090|076|S|effects, including: mental/mood changes (such as anxiety,||
5090|077|S|confusion, depression, thoughts of suicide), inability to keep||
5090|078|S|still/need to pace, muscle spasms/uncontrolled muscle movements||
5090|079|S|(such as twisting neck, arching back), Parkinson-like symptoms||
5090|080|S|(such as shaking, slowed/difficult movement, mask-like facial||
5090|081|S|expression), swelling of the hands/feet, decreased sexual||
5090|082|S|ability, enlarged/tender breasts (in men), changes in||
5090|083|S|menstruation in women, abnormal breast milk production.||
5090|084|S|   This medication may rarely cause a very serious condition||
5090|085|S|called neuroleptic malignant syndrome (NMS). Get medical help||
5090|086|S|right away if you have any of the following symptoms: fever,||
5090|087|S|muscle stiffness, severe confusion, sweating, fast/irregular||
5090|088|S|heartbeat.||
5090|089|S|   A very serious allergic reaction to this drug is rare.||
5090|090|S|However, get medical help right away if you notice any symptoms||
5090|091|S|of a serious allergic reaction, including: rash, itching/swelling||
5090|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5090|093|S|breathing.||
5090|094|S|   This is not a complete list of possible side effects. If you||
5090|095|S|notice other effects not listed above, contact your doctor or||
5090|096|S|pharmacist.||
5090|097|S|   In the US -||
5090|098|S|   Call your doctor for medical advice about side effects. You||
5090|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5090|100|S|www.fda.gov/medwatch.||
5090|101|S|   In Canada - Call your doctor for medical advice about side||
5090|102|S|effects. You may report side effects to Health Canada at||
5090|103|S|1-866-234-2345.||
5090|104|B|||
5090|105|P|PRECAUTIONS:  Before using metoclopramide, tell your doctor or||
5090|106|P|pharmacist if you are allergic to it; or if you have any other||
5090|107|P|allergies. This product may contain inactive ingredients, which||
5090|108|P|can cause allergic reactions or other problems. Talk to your||
5090|109|P|pharmacist for more details.||
5090|110|P|   Before using this medication, tell your doctor or pharmacist||
5090|111|P|your medical history, especially of: history of movement/muscle||
5090|112|P|disorders (such as tardive dyskinesia, dystonia) caused by a||
5090|113|P|medication, bleeding/blockage/hole in the intestines/stomach, a||
5090|114|P|certain adrenal gland tumor (pheochromocytoma), seizures,||
5090|115|P|mental/mood problems (such as depression, thoughts of suicide),||
5090|116|P|Parkinson's disease, high blood pressure, heart failure, liver||
5090|117|P|disease, kidney problems, a certain blood enzyme problem||
5090|118|P|(NADH-cytochrome b5 reductase deficiency), breast cancer.||
5090|119|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5090|120|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5090|121|P|machinery, or do anything that needs alertness until you can do||
5090|122|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5090|123|P|are using marijuana (cannabis).||
5090|124|P|   Before having surgery, tell your doctor or dentist about all||
5090|125|P|the products you use (including prescription drugs,||
5090|126|P|nonprescription drugs, and herbal products).||
5090|127|P|   If you have diabetes, this product may make it harder to||
5090|128|P|control your blood sugar. Check your blood sugar regularly as||
5090|129|P|directed and share the results with your doctor. Tell your doctor||
5090|130|P|right away if you have high or low blood sugar. Your doctor may||
5090|131|P|need to adjust your diabetes medication, exercise program, or||
5090|132|P|diet.||
5090|133|P|   Children may be more sensitive to the side effects of this||
5090|134|P|drug, especially muscle spasms/uncontrolled muscle movements.||
5090|135|P|   Older adults may be more sensitive to the effects of this||
5090|136|P|drug, especially drowsiness, tardive dyskinesia, and||
5090|137|P|Parkinson-like side effects. Drowsiness can increase the risk of||
5090|138|P|falling.||
5090|139|P|   During pregnancy, this medication should be used only when||
5090|140|P|clearly needed. Discuss the risks and benefits with your doctor.||
5090|141|P|   This drug passes into breast milk and may have undesirable||
5090|142|P|effects on a nursing infant. Consult your doctor before||
5090|143|P|breastfeeding.||
5090|144|B|||
5090|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5090|146|I|medications work or increase your risk for serious side effects.||
5090|147|I|This document does not contain all possible drug interactions.||
5090|148|I|Keep a list of all the products you use (including||
5090|149|I|prescription/nonprescription drugs and herbal products) and share||
5090|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
5090|151|I|the dosage of any medicines without your doctor's approval.||
5090|152|I|   Some products that may interact with this drug include:||
5090|153|I|antipsychotic drugs (such as aripiprazole, haloperidol),||
5090|154|I|atovaquone, dopamine agonists (such as cabergoline, pergolide,||
5090|155|I|ropinirole), fosfomycin, MAO inhibitors (isocarboxazid,||
5090|156|I|linezolid, metaxalone, methylene blue, moclobemide, phenelzine,||
5090|157|I|procarbazine, rasagiline, safinamide, selegiline,||
5090|158|I|tranylcypromine), pramlintide, phenothiazines (such as||
5090|159|I|promethazine, prochlorperazine), rivastigmine.||
5090|160|I|   Metoclopramide causes food and medication to move through your||
5090|161|I|stomach more quickly, which may affect the absorption of some||
5090|162|I|drugs. Talk to your doctor or pharmacist to see if any of the||
5090|163|I|drugs that you are taking may be affected.||
5090|164|I|   Tell your doctor or pharmacist if you are taking other||
5090|165|I|products that cause drowsiness, including alcohol, marijuana||
5090|166|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
5090|167|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
5090|168|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
5090|169|I|codeine).||
5090|170|I|   Check the labels on all your medicines (such as allergy or||
5090|171|I|cough-and-cold products) because they may contain ingredients||
5090|172|I|that cause drowsiness. Ask your pharmacist about using those||
5090|173|I|products safely.||
5090|174|B|||
5090|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5090|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5090|177|O|poison control center right away. US residents can call||
5090|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5090|179|B|||
5090|180|N|NOTES:  Keep all medical and lab appointments.||
5090|181|B|||
5090|182|D|MISSED DOSE:  It is important to get each dose of this medication||
5090|183|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
5090|184|D|right away for a new dosing schedule.||
5090|185|B|||
5090|186|R|STORAGE:  Not applicable. This medication is given in a hospital||
5090|187|R|and will not be stored at home.||
5090|188|B|||
5090|189|A|Information last revised August 2024.||
5090|190|A|Copyright(c) 2025 First Databank, Inc.||
5090|191|B|||
5092|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5092|002|Z|does NOT have all possible information about this product. This||
5092|003|Z|information does not assure that this product is safe, effective,||
5092|004|Z|or appropriate for you. This information is not individual||
5092|005|Z|medical advice and does not substitute for the advice of your||
5092|006|Z|health care professional. Always ask your health care||
5092|007|Z|professional for complete information about this product and your||
5092|008|Z|specific health needs.||
5092|009|B|||
5092|010|T|FLUVASTATIN - ORAL||
5092|011|F|(FLEW-vuh-stat-in)||
5092|012|B|||
5092|013|C|COMMON BRAND NAME(S): Lescol||
5092|014|B|||
5092|015|U|USES:  Fluvastatin is used along with a proper diet to help lower||
5092|016|U|"bad" cholesterol and fats (such as LDL, triglycerides) and raise||
5092|017|U|"good" cholesterol (HDL) in the blood. It belongs to a group of||
5092|018|U|drugs known as "statins." It works by reducing the amount of||
5092|019|U|cholesterol made by the liver. Lowering "bad" cholesterol and||
5092|020|U|triglycerides and raising "good" cholesterol decreases the risk||
5092|021|U|of heart disease and helps prevent strokes and heart attacks.||
5092|022|U|   In addition to eating a proper diet (such as a||
5092|023|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
5092|024|U|help this medication work better include exercising, losing||
5092|025|U|weight if overweight, and stopping smoking. Consult your doctor||
5092|026|U|for more details.||
5092|027|B|||
5092|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5092|029|H|from your pharmacist before you start taking fluvastatin and each||
5092|030|H|time you get a refill. If you have any questions, ask your doctor||
5092|031|H|or pharmacist.||
5092|032|H|   Take this medication by mouth with or without food as directed||
5092|033|H|by your doctor, usually once daily in the evening. Some patients||
5092|034|H|may be directed to take this medication twice daily. Do not open||
5092|035|H|the capsules.||
5092|036|H|   The dosage is based on your medical condition, response to||
5092|037|H|treatment, age, and other medications you may be taking. Be sure||
5092|038|H|to tell your doctor and pharmacist about all the products you use||
5092|039|H|(including prescription drugs, nonprescription drugs, and herbal||
5092|040|H|products).||
5092|041|H|   If you also take certain other drugs to lower your cholesterol||
5092|042|H|(bile acid-binding resins such as cholestyramine or colestipol),||
5092|043|H|take fluvastatin at least 1 hour before or at least 4 hours after||
5092|044|H|taking these medications. These products can react with||
5092|045|H|fluvastatin, preventing its full absorption.||
5092|046|H|   Take this medication regularly in order to get the most||
5092|047|H|benefit from it. Remember to take it at the same time(s) each||
5092|048|H|day. Keep taking this medication even if you feel well. Most||
5092|049|H|people with high cholesterol or triglycerides do not feel sick.||
5092|050|H|   It is very important to continue to follow your doctor's||
5092|051|H|advice about diet and exercise. It may take up to 4 weeks before||
5092|052|H|you get the full benefit of this drug.||
5092|053|B|||
5092|054|S|SIDE EFFECTS:  Stomach upset may occur. If this effect lasts or||
5092|055|S|gets worse, tell your doctor or pharmacist promptly.||
5092|056|S|   Remember that this medication has been prescribed because your||
5092|057|S|doctor has judged that the benefit to you is greater than the||
5092|058|S|risk of side effects. Many people using this medication do not||
5092|059|S|have serious side effects.||
5092|060|S|   A very small number of people taking fluvastatin may have mild||
5092|061|S|memory problems or confusion. If these rare effects occur, talk||
5092|062|S|to your doctor.||
5092|063|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
5092|064|S|doctor about the benefits and risks.||
5092|065|S|   This drug may rarely cause muscle problems (which can rarely||
5092|066|S|lead to very serious conditions called rhabdomyolysis and||
5092|067|S|autoimmune myopathy). Tell your doctor right away if you develop||
5092|068|S|any of these symptoms during treatment and if these symptoms last||
5092|069|S|after your doctor stops this drug: muscle||
5092|070|S|pain/tenderness/weakness (especially with fever or unusual||
5092|071|S|tiredness), signs of kidney problems (such as change in the||
5092|072|S|amount of urine).||
5092|073|S|   This medication may rarely cause liver problems. Tell your||
5092|074|S|doctor right away if you develop symptoms of liver problems,||
5092|075|S|including: nausea/vomiting that doesn't stop, yellowing||
5092|076|S|eyes/skin, dark urine, stomach/abdominal pain.||
5092|077|S|   A very serious allergic reaction to this drug is rare.||
5092|078|S|However, get medical help right away if you notice any symptoms||
5092|079|S|of a serious allergic reaction, including: rash, itching/swelling||
5092|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5092|081|S|breathing.||
5092|082|S|   This is not a complete list of possible side effects. If you||
5092|083|S|notice other effects not listed above, contact your doctor or||
5092|084|S|pharmacist.||
5092|085|S|   In the US -||
5092|086|S|   Call your doctor for medical advice about side effects. You||
5092|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5092|088|S|www.fda.gov/medwatch.||
5092|089|S|   In Canada - Call your doctor for medical advice about side||
5092|090|S|effects. You may report side effects to Health Canada at||
5092|091|S|1-866-234-2345.||
5092|092|B|||
5092|093|P|PRECAUTIONS:  Before taking fluvastatin, tell your doctor or||
5092|094|P|pharmacist if you are allergic to it; or if you have any other||
5092|095|P|allergies. This product may contain inactive ingredients, which||
5092|096|P|can cause allergic reactions or other problems. Talk to your||
5092|097|P|pharmacist for more details.||
5092|098|P|   Before using this medication, tell your doctor or pharmacist||
5092|099|P|your medical history, especially of: liver disease, kidney||
5092|100|P|disease, alcohol use.||
5092|101|P|   Before having surgery, tell your doctor or dentist about all||
5092|102|P|the products you use (including prescription drugs,||
5092|103|P|nonprescription drugs, and herbal products).||
5092|104|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
5092|105|P|your risk for liver problems, especially when combined with||
5092|106|P|fluvastatin. Ask your doctor or pharmacist for more information.||
5092|107|P|   Older adults may be more sensitive to the side effects of this||
5092|108|P|drug, especially muscle problems.||
5092|109|P|   During pregnancy, this medication should be used only when||
5092|110|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
5092|111|P|benefits with your doctor.||
5092|112|P|   It is unknown if this medication passes into breast milk.||
5092|113|P|Because of the possible risk to the infant, breastfeeding is not||
5092|114|P|recommended while using this medication. Consult your doctor||
5092|115|P|before breastfeeding.||
5092|116|B|||
5092|117|I|DRUG INTERACTIONS:  See also How to Use section.||
5092|118|I|   Drug interactions may change how your medications work or||
5092|119|I|increase your risk for serious side effects. This document does||
5092|120|I|not contain all possible drug interactions. Keep a list of all||
5092|121|I|the products you use (including prescription/nonprescription||
5092|122|I|drugs and herbal products) and share it with your doctor and||
5092|123|I|pharmacist. Do not start, stop, or change the dosage of any||
5092|124|I|medicines without your doctor's approval.||
5092|125|I|   Some products that may interact with this drug include:||
5092|126|I|colchicine, daptomycin, gemfibrozil, phenytoin.||
5092|127|I|   Do not take any red yeast rice products while you are taking||
5092|128|I|fluvastatin because some red yeast rice products may also contain||
5092|129|I|a statin called lovastatin. Taking fluvastatin and red yeast rice||
5092|130|I|products together can increase your risk of serious muscle and||
5092|131|I|liver problems.||
5092|132|B|||
5092|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5092|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5092|135|O|poison control center right away. US residents can call||
5092|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5092|137|B|||
5092|138|N|NOTES:  Do not share this medication with others.||
5092|139|N|   Lab and/or medical tests (such as blood||
5092|140|N|cholesterol/triglyceride levels, liver function) should be done||
5092|141|N|while you are taking this medication. Keep all medical and lab||
5092|142|N|appointments. Consult your doctor for more details.||
5092|143|B|||
5092|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5092|145|D|remember. If it is near the time of the next dose, skip the||
5092|146|D|missed dose. Take your next dose at the regular time. Do not||
5092|147|D|double the dose to catch up.||
5092|148|B|||
5092|149|R|STORAGE:  Store at room temperature away from light and moisture.||
5092|150|R|Do not store in the bathroom. Keep all medications away from||
5092|151|R|children and pets.||
5092|152|R|   Do not flush medications down the toilet or pour them into a||
5092|153|R|drain unless instructed to do so. Properly discard this product||
5092|154|R|when it is expired or no longer needed. Consult your pharmacist||
5092|155|R|or local waste disposal company.||
5092|156|B|||
5092|157|A|Information last revised May 2024.||
5092|158|A|Copyright(c) 2025 First Databank, Inc.||
5092|159|B|||
5094|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5094|002|Z|does NOT have all possible information about this product. This||
5094|003|Z|information does not assure that this product is safe, effective,||
5094|004|Z|or appropriate for you. This information is not individual||
5094|005|Z|medical advice and does not substitute for the advice of your||
5094|006|Z|health care professional. Always ask your health care||
5094|007|Z|professional for complete information about this product and your||
5094|008|Z|specific health needs.||
5094|009|B|||
5094|010|T|METHYLPHENIDATE SUSTAINED-ACTION, OSMOTIC - ORAL||
5094|011|F|(METH-il-FEN-i-date)||
5094|012|B|||
5094|013|C|COMMON BRAND NAME(S): Concerta||
5094|014|B|||
5094|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
5094|016|W|serious (possibly fatal) heart and blood pressure problems.||
5094|017|W|   This medication can be habit-forming and should be used||
5094|018|W|cautiously by people who have mental/mood disorders or a||
5094|019|W|substance use disorder (such as overuse of or addiction to||
5094|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
5094|021|W|you have a personal or family history of a substance use||
5094|022|W|disorder. Do not increase your dose, use it more often, or use it||
5094|023|W|for a longer time or in a different way than prescribed. Doing so||
5094|024|W|may result in a decrease in the effect of this drug, drug||
5094|025|W|dependence, or abnormal thoughts/behavior.||
5094|026|W|   Your doctor may monitor you for a while after the medication||
5094|027|W|is stopped, especially if you have taken this drug for a long||
5094|028|W|time or in high doses. (See also How to Use section.)||
5094|029|B|||
5094|030|U|USES:  This medication is used to treat attention deficit||
5094|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
5094|032|U|of certain natural substances in the brain. Methylphenidate||
5094|033|U|belongs to a class of drugs known as stimulants. It can help||
5094|034|U|increase your ability to pay attention, stay focused on an||
5094|035|U|activity, and control behavior problems. It may also help you to||
5094|036|U|organize your tasks and improve listening skills.||
5094|037|B|||
5094|038|V|OTHER USES:  This section contains uses of this drug that are not||
5094|039|V|listed in the approved professional labeling for the drug but||
5094|040|V|that may be prescribed by your health care professional. Use this||
5094|041|V|drug for a condition that is listed in this section only if it||
5094|042|V|has been so prescribed by your health care professional.||
5094|043|V|   This drug may also be used for a certain sleep disorder||
5094|044|V|(narcolepsy).||
5094|045|B|||
5094|046|H|HOW TO USE:  Read the Medication Guide provided by your||
5094|047|H|pharmacist before you start taking methylphenidate and each time||
5094|048|H|you get a refill. If you have any questions, ask your doctor or||
5094|049|H|pharmacist.||
5094|050|H|   Take this medication by mouth with or without food as directed||
5094|051|H|by your doctor, usually once daily in the morning. Taking this||
5094|052|H|medication late in the day may cause trouble sleeping (insomnia).||
5094|053|H|   Swallow this medication with a full glass of liquid (8||
5094|054|H|ounces/240 milliliters). Swallow the tablets whole. Do not crush||
5094|055|H|or chew the tablets. Doing so can release all of the drug at||
5094|056|H|once, increasing the risk of side effects.||
5094|057|H|   Take this medication regularly to get the most benefit from||
5094|058|H|it. To help you remember, take it at the same time each day.||
5094|059|H|   The dosage is based on your medical condition and response to||
5094|060|H|treatment. Your doctor may direct you to gradually increase or||
5094|061|H|decrease your dose. Also, if you have used it for a long time, do||
5094|062|H|not suddenly stop using this drug without consulting your doctor.||
5094|063|H|   If you suddenly stop using this medication, you may have||
5094|064|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
5094|065|H|other mental/mood changes). To help prevent withdrawal, your||
5094|066|H|doctor may lower your dose slowly. Withdrawal is more likely if||
5094|067|H|you have used methylphenidate for a long time or in high doses.||
5094|068|H|Tell your doctor or pharmacist right away if you have withdrawal.||
5094|069|H|   When used for a long time, this medication may not work as||
5094|070|H|well. Talk with your doctor if this medication stops working||
5094|071|H|well.||
5094|072|H|   Though it helps many people, this medication may sometimes||
5094|073|H|cause addiction. This risk may be higher if you have a substance||
5094|074|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
5094|075|H|Take this medication exactly as prescribed to lower the risk of||
5094|076|H|addiction. Ask your doctor or pharmacist for more details.||
5094|077|H|   Tell your doctor if your condition does not get better or if||
5094|078|H|it gets worse.||
5094|079|B|||
5094|080|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
5094|081|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
5094|082|S|If any of these effects last or get worse, tell your doctor or||
5094|083|S|pharmacist promptly.||
5094|084|S|   An empty tablet shell may appear in your stool. This effect is||
5094|085|S|harmless because your body has already absorbed the medication.||
5094|086|S|   Remember that this medication has been prescribed because your||
5094|087|S|doctor has judged that the benefit to you is greater than the||
5094|088|S|risk of side effects. Many people using this medication do not||
5094|089|S|have serious side effects.||
5094|090|S|   This medication may raise your blood pressure. Check your||
5094|091|S|blood pressure regularly and tell your doctor if the results are||
5094|092|S|high.||
5094|093|S|   Tell your doctor right away if you have any serious side||
5094|094|S|effects, including: signs of blood flow problems in the fingers||
5094|095|S|or toes (such as coldness, numbness, pain, or skin color||
5094|096|S|changes), unusual wounds on the fingers or toes,||
5094|097|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
5094|098|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
5094|099|S|thoughts of suicide), uncontrolled muscle movements (such as||
5094|100|S|twitching, shaking), sudden outbursts of words/sounds that are||
5094|101|S|hard to control, vision changes (such as blurred vision).||
5094|102|S|   Get medical help right away if you have any very serious side||
5094|103|S|effects, including: fainting, seizure, symptoms of a heart attack||
5094|104|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
5094|105|S|sweating), symptoms of a stroke (such as weakness on one side of||
5094|106|S|the body, trouble speaking, sudden vision changes, confusion).||
5094|107|S|   Rarely, males (including young boys and teens) may have a||
5094|108|S|painful or prolonged erection lasting 4 or more hours while using||
5094|109|S|this medication. Caregivers/parents should also be watchful for||
5094|110|S|this serious side effect in boys. If a painful or prolonged||
5094|111|S|erection occurs, stop using this drug and get medical help right||
5094|112|S|away, or permanent problems could occur. Ask your doctor or||
5094|113|S|pharmacist for more details.||
5094|114|S|   A very serious allergic reaction to this drug is rare.||
5094|115|S|However, get medical help right away if you notice any symptoms||
5094|116|S|of a serious allergic reaction, including: rash, itching/swelling||
5094|117|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5094|118|S|breathing.||
5094|119|S|   This is not a complete list of possible side effects. If you||
5094|120|S|notice other effects not listed above, contact your doctor or||
5094|121|S|pharmacist.||
5094|122|S|   In the US -||
5094|123|S|   Call your doctor for medical advice about side effects. You||
5094|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5094|125|S|www.fda.gov/medwatch.||
5094|126|S|   In Canada - Call your doctor for medical advice about side||
5094|127|S|effects. You may report side effects to Health Canada at||
5094|128|S|1-866-234-2345.||
5094|129|B|||
5094|130|P|PRECAUTIONS:  See also Warning section.||
5094|131|P|   Before taking methylphenidate, tell your doctor or pharmacist||
5094|132|P|if you are allergic to it; or to dexmethylphenidate; or if you||
5094|133|P|have any other allergies. This product may contain inactive||
5094|134|P|ingredients, which can cause allergic reactions or other||
5094|135|P|problems. Talk to your pharmacist for more details.||
5094|136|P|   Before using this medication, tell your doctor or pharmacist||
5094|137|P|your medical history, especially of: high blood pressure, blood||
5094|138|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
5094|139|P|problems (such as irregular heartbeat, heart failure, previous||
5094|140|P|heart attack, problems with heart structure), family history of||
5094|141|P|heart problems (such as sudden cardiac death, irregular||
5094|142|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
5094|143|P|agitation), personal/family history of mental/mood disorders||
5094|144|P|(such as bipolar disorder, depression, psychosis, suicidal||
5094|145|P|thoughts), personal/family history of uncontrolled muscle||
5094|146|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
5094|147|P|(hyperthyroidism), seizure disorder, throat/stomach/intestinal||
5094|148|P|problems (such as narrowing/blockage).||
5094|149|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5094|150|P|can make you more dizzy. Do not drive, use machinery, or do||
5094|151|P|anything that needs alertness until you can do it safely. Limit||
5094|152|P|alcoholic beverages. Talk to your doctor if you are using||
5094|153|P|marijuana (cannabis).||
5094|154|P|   Before having surgery, tell your doctor or dentist about all||
5094|155|P|the products you use (including prescription drugs,||
5094|156|P|nonprescription drugs, and herbal products).||
5094|157|P|   Children (especially those younger than 6) may be more||
5094|158|P|sensitive to the side effects of this drug, especially weight||
5094|159|P|loss. If used for a long time, this drug may affect a child's||
5094|160|P|growth rate, weight, and final adult height. To reduce the risk,||
5094|161|P|the doctor may recommend briefly stopping the medication from||
5094|162|P|time to time. Check the child's weight and height regularly, and||
5094|163|P|consult your doctor or pharmacist for more details.||
5094|164|P|   Older adults may be more sensitive to the side effects of this||
5094|165|P|drug, especially trouble sleeping, weight loss, or chest pain.||
5094|166|P|   During pregnancy, methylphenidate should be used only when||
5094|167|P|clearly needed. Discuss the risks and benefits with your doctor.||
5094|168|P|   This medication passes into breast milk. Consult your doctor||
5094|169|P|before breastfeeding.||
5094|170|B|||
5094|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5094|172|I|medications work or increase your risk for serious side effects.||
5094|173|I|This document does not contain all possible drug interactions.||
5094|174|I|Keep a list of all the products you use (including||
5094|175|I|prescription/nonprescription drugs and herbal products) and share||
5094|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
5094|177|I|the dosage of any medicines without your doctor's approval.||
5094|178|I|   Taking MAO inhibitors with this medication may cause a serious||
5094|179|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
5094|180|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
5094|181|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
5094|182|I|selegiline, tranylcypromine) during treatment with this||
5094|183|I|medication. Most MAO inhibitors should also not be taken for two||
5094|184|I|weeks before treatment with this medication. Ask your doctor when||
5094|185|I|to start or stop taking this medication.||
5094|186|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
5094|187|I|use medications containing dexmethylphenidate while using||
5094|188|I|methylphenidate.||
5094|189|I|   This medication may interfere with certain medical/lab tests||
5094|190|I|(such as brain scan for Parkinson's disease), possibly causing||
5094|191|I|false test results. Make sure lab personnel and all your doctors||
5094|192|I|know you use this drug.||
5094|193|B|||
5094|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5094|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5094|196|O|poison control center right away. US residents can call||
5094|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5094|198|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
5094|199|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
5094|200|O|loss of consciousness.||
5094|201|B|||
5094|202|N|NOTES:  Do not share this medication with others. Sharing it is||
5094|203|N|against the law.||
5094|204|N|   Lab and/or medical tests (such as blood pressure, complete||
5094|205|N|blood count, height/weight monitoring in children) may be done||
5094|206|N|while you are taking this medication. Keep all medical and lab||
5094|207|N|appointments. Consult your doctor for more details.||
5094|208|N|   There are different brands and forms of this medication||
5094|209|N|available. Not all have the same effects. Do not change brands or||
5094|210|N|forms without consulting your doctor or pharmacist.||
5094|211|B|||
5094|212|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5094|213|D|remember. If it is near bedtime or near the time of the next||
5094|214|D|dose, skip the missed dose. Take your next dose at the regular||
5094|215|D|time. Do not double the dose to catch up.||
5094|216|B|||
5094|217|R|STORAGE:  Store this medication at room temperature away from||
5094|218|R|light and moisture. Do not store in the bathroom. Keep all||
5094|219|R|medications away from children and pets.||
5094|220|R|   Do not flush medications down the toilet or pour them into a||
5094|221|R|drain unless instructed to do so. Properly discard this product||
5094|222|R|when it is expired or no longer needed. Consult your pharmacist||
5094|223|R|or local waste disposal company.||
5094|224|B|||
5094|225|A|Information last revised July 2025.||
5094|226|A|Copyright(c) 2025 First Databank, Inc.||
5094|227|B|||
5095|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5095|002|Z|does NOT have all possible information about this product. This||
5095|003|Z|information does not assure that this product is safe, effective,||
5095|004|Z|or appropriate for you. This information is not individual||
5095|005|Z|medical advice and does not substitute for the advice of your||
5095|006|Z|health care professional. Always ask your health care||
5095|007|Z|professional for complete information about this product and your||
5095|008|Z|specific health needs.||
5095|009|B|||
5095|010|T|FLUOXETINE ENTERIC-COATED - ORAL||
5095|011|F|(flew-OX-eh-teen)||
5095|012|B|||
5095|013|C|COMMON BRAND NAME(S): Prozac Weekly||
5095|014|B|||
5095|015|W|WARNING:  Antidepressant medications are used to treat a variety||
5095|016|W|of conditions, including depression and other mental/mood||
5095|017|W|disorders. These medications can help prevent suicidal||
5095|018|W|thoughts/attempts and provide other important benefits. However,||
5095|019|W|studies have shown that a small number of people (especially||
5095|020|W|people younger than 25) who take antidepressants for any||
5095|021|W|condition may experience worsening depression, other mental/mood||
5095|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
5095|023|W|talk with the doctor about the risks and benefits of||
5095|024|W|antidepressant medication (especially for people younger than||
5095|025|W|25), even if treatment is not for a mental/mood condition.||
5095|026|W|   Tell the doctor right away if you notice worsening||
5095|027|W|depression/other psychiatric conditions, unusual behavior changes||
5095|028|W|(including possible suicidal thoughts/attempts), or other||
5095|029|W|mental/mood changes (including new/worsening anxiety, panic||
5095|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
5095|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
5095|032|W|especially watchful for these symptoms when a new antidepressant||
5095|033|W|is started or when the dose is changed.||
5095|034|B|||
5095|035|U|USES:  This long-acting form of fluoxetine is used to treat||
5095|036|U|depression in people who have been successfully treated with the||
5095|037|U|form of fluoxetine that is taken daily. Fluoxetine belongs to a||
5095|038|U|class of drugs known as selective serotonin reuptake inhibitors||
5095|039|U|(SSRIs). It works by helping to restore the balance of a certain||
5095|040|U|natural substance (serotonin) in the brain.||
5095|041|B|||
5095|042|V|OTHER USES:  This section contains uses of this drug that are not||
5095|043|V|listed in the approved professional labeling for the drug but||
5095|044|V|that may be prescribed by your health care professional. Use this||
5095|045|V|drug for a condition that is listed in this section only if it||
5095|046|V|has been so prescribed by your health care professional.||
5095|047|V|   This drug may also be used for post traumatic stress disorder||
5095|048|V|(PTSD), or for hot flashes that occur with menopause.||
5095|049|B|||
5095|050|H|HOW TO USE:  Read the Medication Guide provided by your||
5095|051|H|pharmacist before you start using fluoxetine and each time you||
5095|052|H|get a refill. If you have any questions, ask your doctor or||
5095|053|H|pharmacist.||
5095|054|H|   Take this medication by mouth with or without food as directed||
5095|055|H|by your doctor, usually once a week. Swallow the capsule whole.||
5095|056|H|Do not crush or chew the contents of the capsule. Start taking||
5095|057|H|this medication 7 days after your last dose of the form of||
5095|058|H|fluoxetine that is taken daily.||
5095|059|H|   The dosage is based on your medical condition and response to||
5095|060|H|treatment. Use this medication regularly to get the most benefit||
5095|061|H|from it. To help you remember, take it on the same day each week.||
5095|062|H|Mark your calendar with a reminder.||
5095|063|H|   Keep taking this medication even if you feel well. Do not stop||
5095|064|H|taking this medication without first consulting your doctor. Some||
5095|065|H|conditions may become worse when the drug is abruptly stopped.||
5095|066|H|Your dose may need to be gradually decreased.||
5095|067|H|   Tell your doctor if your condition does not get better or if||
5095|068|H|it gets worse.||
5095|069|B|||
5095|070|S|SIDE EFFECTS:  See also Warning section.||
5095|071|S|   Nausea, drowsiness, dizziness, anxiety, trouble sleeping, loss||
5095|072|S|of appetite, tiredness, sweating, or yawning may occur. If any of||
5095|073|S|these effects last or get worse, tell your doctor promptly.||
5095|074|S|   Remember that this medication has been prescribed because your||
5095|075|S|doctor has judged that the benefit to you is greater than the||
5095|076|S|risk of side effects. Many people using this medication do not||
5095|077|S|have serious side effects.||
5095|078|S|   Tell your doctor right away if you have any serious side||
5095|079|S|effects, including: unusual or severe mental/mood changes (such||
5095|080|S|as agitation, unusual high energy/excitement, thoughts of||
5095|081|S|suicide), easy bleeding/bruising, muscle weakness/spasm,||
5095|082|S|shakiness (tremor), decreased interest in sex, changes in sexual||
5095|083|S|ability, unusual weight loss.||
5095|084|S|   Get medical help right away if you have any very serious side||
5095|085|S|effects, including: black stools, vomit that looks like coffee||
5095|086|S|grounds, seizures, signs of kidney problems (such as change in||
5095|087|S|the amount of urine), eye pain/swelling/redness, widened pupils,||
5095|088|S|vision changes (such as seeing rainbows around lights at night,||
5095|089|S|blurred vision).||
5095|090|S|   If you have diabetes, fluoxetine may affect your blood sugar||
5095|091|S|levels. Monitor your blood sugar regularly and share the results||
5095|092|S|with your doctor. Your doctor may need to adjust your medication,||
5095|093|S|diet, and exercise when you start or stop fluoxetine.||
5095|094|S|   This medication may increase serotonin and rarely cause a very||
5095|095|S|serious condition called serotonin syndrome/toxicity. The risk||
5095|096|S|increases if you are also taking other drugs that increase||
5095|097|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
5095|098|S|take (see Drug Interactions section). Get medical help right away||
5095|099|S|if you develop some of the following symptoms: fast heartbeat,||
5095|100|S|hallucinations, loss of coordination, severe dizziness, severe||
5095|101|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
5095|102|S|unusual agitation/restlessness.||
5095|103|S|   Rarely, males may have a painful or prolonged erection lasting||
5095|104|S|4 or more hours. If this occurs, stop using this drug and get||
5095|105|S|medical help right away, or permanent problems could occur.||
5095|106|S|   A very serious allergic reaction to this drug is rare.||
5095|107|S|However, get medical help right away if you notice any symptoms||
5095|108|S|of a serious allergic reaction, including: rash, itching/swelling||
5095|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5095|110|S|breathing.||
5095|111|S|   This is not a complete list of possible side effects. If you||
5095|112|S|notice other effects not listed above, contact your doctor or||
5095|113|S|pharmacist.||
5095|114|S|   In the US -||
5095|115|S|   Call your doctor for medical advice about side effects. You||
5095|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5095|117|S|www.fda.gov/medwatch.||
5095|118|S|   In Canada - Call your doctor for medical advice about side||
5095|119|S|effects. You may report side effects to Health Canada at||
5095|120|S|1-866-234-2345.||
5095|121|B|||
5095|122|P|PRECAUTIONS:  Before taking fluoxetine, tell your doctor or||
5095|123|P|pharmacist if you are allergic to it; or if you have any other||
5095|124|P|allergies. This product may contain inactive ingredients, which||
5095|125|P|can cause allergic reactions or other problems. Talk to your||
5095|126|P|pharmacist for more details.||
5095|127|P|   Before using this medication, tell your doctor or pharmacist||
5095|128|P|your medical history, especially of: personal or family history||
5095|129|P|of bipolar/manic-depressive disorder, personal or family history||
5095|130|P|of suicide attempts, liver problems, diabetes, low sodium in the||
5095|131|P|blood (such as may occur while taking "water pills" - diuretics),||
5095|132|P|dehydration, seizures, intestinal ulcers/bleeding (peptic ulcer||
5095|133|P|disease), personal or family history of glaucoma (angle-closure||
5095|134|P|type).||
5095|135|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5095|136|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5095|137|P|machinery, or do anything that needs alertness until you can do||
5095|138|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5095|139|P|are using marijuana (cannabis).||
5095|140|P|   Before having surgery, tell your doctor or dentist about all||
5095|141|P|the products you use (including prescription drugs,||
5095|142|P|nonprescription drugs, and herbal products).||
5095|143|P|   Children may be more sensitive to the side effects of this||
5095|144|P|drug, especially weight loss. Monitor weight and height in||
5095|145|P|children who are taking this drug.||
5095|146|P|   Older adults may be more sensitive to the side effects of this||
5095|147|P|drug, especially bleeding and loss of coordination. Loss of||
5095|148|P|coordination can increase the risk of falling. Older adults may||
5095|149|P|also be more likely to develop low sodium in the blood,||
5095|150|P|especially if they are taking "water pills" (diuretics).||
5095|151|P|   During pregnancy, this medication should be used only when||
5095|152|P|clearly needed. It may harm an unborn baby. Also, babies born to||
5095|153|P|mothers who have used this drug during the last 3 months of||
5095|154|P|pregnancy may rarely develop withdrawal symptoms such as||
5095|155|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
5095|156|P|constant crying. If you notice any of these symptoms in your||
5095|157|P|newborn, tell the doctor promptly.||
5095|158|P|   Since untreated mental/mood problems (such as depression, post||
5095|159|P|traumatic stress disorder) can be a serious condition, do not||
5095|160|P|stop taking this medication unless directed by your doctor. If||
5095|161|P|you are planning pregnancy, become pregnant, or think you may be||
5095|162|P|pregnant, immediately discuss the benefits and risks of using||
5095|163|P|this medication during pregnancy with your doctor.||
5095|164|P|   This medication passes into breast milk and may have||
5095|165|P|undesirable effects on a nursing infant. Consult your doctor||
5095|166|P|before breastfeeding.||
5095|167|B|||
5095|168|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5095|169|I|medications work or increase your risk for serious side effects.||
5095|170|I|This document does not contain all possible drug interactions.||
5095|171|I|Keep a list of all the products you use (including||
5095|172|I|prescription/nonprescription drugs and herbal products) and share||
5095|173|I|it with your doctor and pharmacist. Do not start, stop, or change||
5095|174|I|the dosage of any medicines without your doctor's approval.||
5095|175|I|   Fluoxetine can stay in your body for many weeks after your||
5095|176|I|last dose and may interact with many other medications. Before||
5095|177|I|using any medication, tell your doctor or pharmacist if you have||
5095|178|I|taken fluoxetine in the previous 5 weeks.||
5095|179|I|   Some products that may interact with this drug are: other||
5095|180|I|drugs that can cause bleeding/bruising (including antiplatelet||
5095|181|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
5095|182|I|"blood thinners" such as dabigatran/warfarin).||
5095|183|I|   Taking MAO inhibitors with his medication may cause a serious||
5095|184|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
5095|185|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
5095|186|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
5095|187|I|selegiline, tranylcypromine) during treatment with this||
5095|188|I|medication. Most MAO inhibitors should also not be taken for 2||
5095|189|I|weeks before and at least 5 weeks after treatment with this||
5095|190|I|medication. Ask your doctor when to start or stop taking this||
5095|191|I|medication.||
5095|192|I|   This medication can slow down the removal of other medications||
5095|193|I|from your body, which may affect how they work. Examples of||
5095|194|I|affected drugs include pimozide, thioridazine, vinblastine,||
5095|195|I|antiarrhythmics (such as propafenone, flecainide), tricyclic||
5095|196|I|antidepressants (such as desipramine, imipramine), among others.||
5095|197|I|   Aspirin can increase the risk of bleeding when used with this||
5095|198|I|medication. However, if your doctor has told you to take low-dose||
5095|199|I|aspirin to prevent heart attack or stroke (usually 81-162||
5095|200|I|milligrams a day), you should keep taking the aspirin unless your||
5095|201|I|doctor tells you not to.||
5095|202|I|   The risk of serotonin syndrome/toxicity increases if you are||
5095|203|I|also taking other drugs that increase serotonin. Examples include||
5095|204|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
5095|205|I|antidepressants (including other SSRIs such as||
5095|206|I|citalopram/paroxetine, SNRIs such as duloxetine/venlafaxine),||
5095|207|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
5095|208|I|may be more likely when you start or increase the dose of these||
5095|209|I|drugs.||
5095|210|I|   Tell your doctor or pharmacist if you are taking other||
5095|211|I|products that cause drowsiness including alcohol, marijuana||
5095|212|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
5095|213|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
5095|214|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
5095|215|I|codeine). Check the labels on all your medicines (such as allergy||
5095|216|I|or cough-and-cold products) because they may contain ingredients||
5095|217|I|that cause drowsiness. Ask your pharmacist about using those||
5095|218|I|products safely.||
5095|219|I|   This medication may interfere with certain medical/lab tests||
5095|220|I|(such as brain scan for Parkinson's disease), possibly causing||
5095|221|I|false test results. Make sure lab personnel and all your doctors||
5095|222|I|know you use this drug.||
5095|223|B|||
5095|224|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5095|225|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5095|226|O|poison control center right away. US residents can call||
5095|227|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5095|228|O|Symptoms of overdose may include: fast/irregular heartbeat,||
5095|229|O|severe dizziness, fainting.||
5095|230|B|||
5095|231|N|NOTES:  Do not share this medication with others.||
5095|232|N|   Keep all medical and lab appointments.||
5095|233|B|||
5095|234|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
5095|235|D|right away for a new dosing schedule. Do not double the dose to||
5095|236|D|catch up.||
5095|237|B|||
5095|238|R|STORAGE:  Store at room temperature away from light and moisture.||
5095|239|R|Do not store in the bathroom. Keep all medications away from||
5095|240|R|children and pets.||
5095|241|R|   Do not flush medications down the toilet or pour them into a||
5095|242|R|drain unless instructed to do so. Properly discard this product||
5095|243|R|when it is expired or no longer needed. Consult your pharmacist||
5095|244|R|or local waste disposal company.||
5095|245|B|||
5095|246|A|Information last revised February 2025.||
5095|247|A|Copyright(c) 2025 First Databank, Inc.||
5095|248|B|||
5096|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5096|002|Z|does NOT have all possible information about this product. This||
5096|003|Z|information does not assure that this product is safe, effective,||
5096|004|Z|or appropriate for you. This information is not individual||
5096|005|Z|medical advice and does not substitute for the advice of your||
5096|006|Z|health care professional. Always ask your health care||
5096|007|Z|professional for complete information about this product and your||
5096|008|Z|specific health needs.||
5096|009|B|||
5096|010|T|GUAIFENESIN/DEXTROMETHORPHAN SUSTAINED-RELEASE TABLET - ORAL||
5096|011|F|(gweye-FEN-eh-sin/dex-trow-meth-OR-fan)||
5096|012|B|||
5096|013|C|COMMON BRAND NAME(S): Bidex-A, Humibid DM, Mucinex DM||
5096|014|B|||
5096|015|U|USES:  This combination medication is used to relieve coughs||
5096|016|U|caused by the common cold, bronchitis, and other breathing||
5096|017|U|illnesses. Guaifenesin belongs to a class of drugs known as||
5096|018|U|expectorants. It works by thinning and loosening mucus in the||
5096|019|U|airways, clearing congestion, and making breathing easier.||
5096|020|U|Dextromethorphan belongs to a class of drugs known as cough||
5096|021|U|suppressants. It acts on a part of the brain (cough center) to||
5096|022|U|reduce the urge to cough.||
5096|023|U|   If you are self-treating with this medication, it is important||
5096|024|U|to read the package instructions carefully before you start using||
5096|025|U|this product to be sure it is right for you. (See also||
5096|026|U|Precautions section.)||
5096|027|U|   Cough-and-cold products have not been shown to be safe or||
5096|028|U|effective in children younger than 6 years. This product||
5096|029|U|(sustained-release) is not recommended for use in children||
5096|030|U|younger than 12 years unless specifically directed by the doctor.||
5096|031|U|Ask your doctor or pharmacist for more details about using your||
5096|032|U|product safely.||
5096|033|U|   These products do not cure or shorten the length of the common||
5096|034|U|cold and may cause serious side effects. To decrease the risk for||
5096|035|U|serious side effects, carefully follow all dosage directions. Do||
5096|036|U|not use this product to make a child sleepy. Do not give other||
5096|037|U|cough-and-cold medication that might contain the same or similar||
5096|038|U|ingredients (see also Drug Interactions section). Ask the doctor||
5096|039|U|or pharmacist about other ways to relieve cough and cold symptoms||
5096|040|U|(such as drinking enough fluids, using a humidifier or saline||
5096|041|U|nose drops/spray).||
5096|042|B|||
5096|043|H|HOW TO USE:  Take this medication by mouth with or without food,||
5096|044|H|as directed by your doctor, usually every 12 hours with a full||
5096|045|H|glass of water. If you are self-treating, follow all directions||
5096|046|H|on the product package. If you have any questions, ask your||
5096|047|H|doctor or pharmacist.||
5096|048|H|   Dosage is based on your age, medical condition, and response||
5096|049|H|to treatment. Do not take more than 2 doses in 24 hours. Do not||
5096|050|H|increase your dose or take this drug more often than directed.||
5096|051|H|   Do not crush or chew this medication. Doing so can release all||
5096|052|H|of the drug at once, increasing the risk of side effects. Also,||
5096|053|H|do not split the tablets unless they have a score line and your||
5096|054|H|doctor or pharmacist tells you to do so. Swallow the whole or||
5096|055|H|split tablet without crushing or chewing.||
5096|056|H|   Drink plenty of fluids while taking this medication. Fluids||
5096|057|H|will help to break up mucus and clear congestion.||
5096|058|H|   Improper use of this medication (abuse) may result in serious||
5096|059|H|harm (such as brain damage, seizure, death). Do not increase your||
5096|060|H|dose, take it more often, or use it for a longer time than||
5096|061|H|directed.||
5096|062|H|   Tell your doctor if your cough returns, or if it is||
5096|063|H|accompanied by headache that doesn't go away, fever, severe sore||
5096|064|H|throat, rash, or if it lasts or gets worse after 7 days. These||
5096|065|H|may be signs of a serious medical problem. Get medical help right||
5096|066|H|away if you think you may have a serious medical problem.||
5096|067|B|||
5096|068|S|SIDE EFFECTS:  Dizziness, drowsiness, nausea, and vomiting may||
5096|069|S|occur. If any of these effects last or get worse, tell your||
5096|070|S|doctor or pharmacist promptly.||
5096|071|S|   If your doctor has directed you to use this medication,||
5096|072|S|remember that your doctor has judged that the benefit to you is||
5096|073|S|greater than the risk of side effects. Many people using this||
5096|074|S|medication do not have serious side effects.||
5096|075|S|   A very serious allergic reaction to this drug is rare.||
5096|076|S|However, get medical help right away if you notice any symptoms||
5096|077|S|of a serious allergic reaction, including: rash, itching/swelling||
5096|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5096|079|S|breathing.||
5096|080|S|   This is not a complete list of possible side effects. If you||
5096|081|S|notice other effects not listed above, contact your doctor or||
5096|082|S|pharmacist.||
5096|083|S|   In the US -||
5096|084|S|   Call your doctor for medical advice about side effects. You||
5096|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5096|086|S|www.fda.gov/medwatch.||
5096|087|S|   In Canada - Call your doctor for medical advice about side||
5096|088|S|effects. You may report side effects to Health Canada at||
5096|089|S|1-866-234-2345.||
5096|090|B|||
5096|091|P|PRECAUTIONS:  Before taking this drug, tell your doctor or||
5096|092|P|pharmacist if you are allergic to guaifenesin or||
5096|093|P|dextromethorphan; or if you have any other allergies. This||
5096|094|P|product may contain inactive ingredients, which can cause||
5096|095|P|allergic reactions or other problems. Talk to your pharmacist for||
5096|096|P|more details.||
5096|097|P|   Before using this medication, tell your doctor or pharmacist||
5096|098|P|your medical history, especially of: breathing problems (such as||
5096|099|P|emphysema, chronic bronchitis, asthma, smoker's cough), cough||
5096|100|P|with blood or large amounts of mucus, liver problems.||
5096|101|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5096|102|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5096|103|P|machinery, or do anything that needs alertness until you can do||
5096|104|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5096|105|P|are using marijuana (cannabis).||
5096|106|P|   Before having surgery, tell your doctor or dentist about all||
5096|107|P|the products you use (including prescription drugs,||
5096|108|P|nonprescription drugs, and herbal products).||
5096|109|P|   During pregnancy, this medication should be used only when||
5096|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
5096|111|P|   Dextromethorphan passes into breast milk. It is unknown if||
5096|112|P|guaifenesin passes into breast milk. Consult your doctor before||
5096|113|P|breastfeeding.||
5096|114|B|||
5096|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5096|116|I|medications work or increase your risk for serious side effects.||
5096|117|I|This document does not contain all possible drug interactions.||
5096|118|I|Keep a list of all the products you use (including||
5096|119|I|prescription/nonprescription drugs and herbal products) and share||
5096|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
5096|121|I|the dosage of any medicines without your doctor's approval.||
5096|122|I|   Taking certain MAO inhibitors with this medication may cause a||
5096|123|I|serious (possibly fatal) drug interaction. Avoid taking||
5096|124|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
5096|125|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
5096|126|I|tranylcypromine during treatment with this medication. Most MAO||
5096|127|I|inhibitors should also not be taken for two weeks before||
5096|128|I|treatment with this medication. Ask your doctor when to start or||
5096|129|I|stop taking this medication.||
5096|130|I|   A product that may interact with this drug is: rolapitant.||
5096|131|I|   Guaifenesin and dextromethorphan are available in both||
5096|132|I|prescription and nonprescription products. Check the labels of||
5096|133|I|all your medications to make sure you are not taking more than||
5096|134|I|one product containing guaifenesin or dextromethorphan.||
5096|135|I|   Guaifenesin may interfere with certain lab tests (such as||
5096|136|I|urine levels of certain acids), possibly causing false test||
5096|137|I|results. Make sure lab personnel and all your doctors know you||
5096|138|I|use this drug.||
5096|139|B|||
5096|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5096|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5096|142|O|poison control center right away. US residents can call||
5096|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5096|144|O|Symptoms of overdose may include: extreme drowsiness, blurred||
5096|145|O|vision, confusion, hallucinations, slow/shallow breathing,||
5096|146|O|seizures.||
5096|147|B|||
5096|148|N|NOTES:  If your doctor prescribed this medication, do not share||
5096|149|N|this medication with others.||
5096|150|N|   Keep all medical and lab appointments.||
5096|151|N|   This medication is for temporary use only. Do not take this||
5096|152|N|medication for more than 7 days unless your doctor tells you to||
5096|153|N|do so. Tell your doctor if your condition lasts longer than 7||
5096|154|N|days.||
5096|155|B|||
5096|156|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5096|157|D|remember. If it is near the time of the next dose, skip the||
5096|158|D|missed dose. Take your next dose at the regular time. Do not||
5096|159|D|double the dose to catch up.||
5096|160|B|||
5096|161|R|STORAGE:  Store at room temperature away from light and moisture.||
5096|162|R|Do not store in the bathroom. Keep all medications away from||
5096|163|R|children and pets.||
5096|164|R|   Do not flush medications down the toilet or pour them into a||
5096|165|R|drain unless instructed to do so. Properly discard this product||
5096|166|R|when it is expired or no longer needed. Consult your pharmacist||
5096|167|R|or local waste disposal company.||
5096|168|B|||
5096|169|A|Information last revised July 2025.||
5096|170|A|Copyright(c) 2025 First Databank, Inc.||
5096|171|B|||
5099|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5099|002|Z|does NOT have all possible information about this product. This||
5099|003|Z|information does not assure that this product is safe, effective,||
5099|004|Z|or appropriate for you. This information is not individual||
5099|005|Z|medical advice and does not substitute for the advice of your||
5099|006|Z|health care professional. Always ask your health care||
5099|007|Z|professional for complete information about this product and your||
5099|008|Z|specific health needs.||
5099|009|B|||
5099|010|T|ATROPINE SULFATE OINTMENT - OPHTHALMIC||
5099|011|F|(AT-roe-peen SUL-fate)||
5099|012|B|||
5099|013|U|USES:  This medication is used before eye examinations (such as||
5099|014|U|refraction) and to treat certain eye conditions (such as||
5099|015|U|uveitis). It belongs to a class of drugs known as||
5099|016|U|anticholinergics. Atropine works by widening (dilating) the pupil||
5099|017|U|of the eye.||
5099|018|B|||
5099|019|H|HOW TO USE:  Use this medication in the affected eye(s) as||
5099|020|H|directed by your doctor, usually 3 times a day.||
5099|021|H|   To apply eye ointments, wash hands first. To avoid||
5099|022|H|contamination, do not touch the tube tip or let it touch your eye||
5099|023|H|or any other surface. Tilt your head back, look upward, and||
5099|024|H|gently pull down the lower eyelid to make a pouch. Place a 1/4||
5099|025|H|inch (0.5 centimeter) strip of ointment into the pouch. Gently||
5099|026|H|close the eye and roll the eyeball in all directions to spread||
5099|027|H|the medication. Try not to blink and do not rub the eye.||
5099|028|H|   Repeat these steps for your other eye if so directed.||
5099|029|H|   Do not use the ointment if it has changed color.||
5099|030|H|   Wipe the tip of the ointment tube with a clean tissue to||
5099|031|H|remove extra medication before recapping it.||
5099|032|H|   If you are using another kind of eye medication (such as drops||
5099|033|H|or ointments), wait at least 5-10 minutes before applying other||
5099|034|H|medications. Use eye drops before eye ointments to allow the||
5099|035|H|drops to enter the eye.||
5099|036|H|   Wait several minutes for your vision to clear before driving||
5099|037|H|or operating machinery.||
5099|038|H|   If you are using this medication on a regular schedule, you||
5099|039|H|can get the most benefit from it by not missing any doses. To||
5099|040|H|help you remember, use it at the same times each day. Keep using||
5099|041|H|it for the full time prescribed.||
5099|042|H|   Tell your doctor if your condition does not get better or if||
5099|043|H|it gets worse.||
5099|044|B|||
5099|045|S|SIDE EFFECTS:  Burning/stinging/redness of the eye, eye||
5099|046|S|irritation, or temporary blurred vision may occur. If any of||
5099|047|S|these effects last or get worse, tell your doctor or pharmacist||
5099|048|S|promptly.||
5099|049|S|   Remember that this medication has been prescribed because your||
5099|050|S|doctor has judged that the benefit to you is greater than the||
5099|051|S|risk of side effects. Many people using this medication do not||
5099|052|S|have serious side effects.||
5099|053|S|   Tell your doctor right away if you have any serious side||
5099|054|S|effects, including: dizziness, fainting, new or increased eye||
5099|055|S|pressure/pain/swelling/discharge, slow/shallow breathing,||
5099|056|S|mental/mood changes (such as confusion, agitation),||
5099|057|S|fast/irregular heartbeat.||
5099|058|S|   A very serious allergic reaction to this product is rare.||
5099|059|S|However, get medical help right away if you notice any symptoms||
5099|060|S|of a serious allergic reaction, including: rash, itching/swelling||
5099|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5099|062|S|breathing.||
5099|063|S|   This is not a complete list of possible side effects. If you||
5099|064|S|notice other effects not listed above, contact your doctor or||
5099|065|S|pharmacist.||
5099|066|S|   In the US -||
5099|067|S|   Call your doctor for medical advice about side effects. You||
5099|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5099|069|S|www.fda.gov/medwatch.||
5099|070|S|   In Canada - Call your doctor for medical advice about side||
5099|071|S|effects. You may report side effects to Health Canada at||
5099|072|S|1-866-234-2345.||
5099|073|B|||
5099|074|P|PRECAUTIONS:  Before using atropine, tell your doctor or||
5099|075|P|pharmacist if you are allergic to it; or to belladonna alkaloids||
5099|076|P|(such as hyoscyamine, scopolamine); or if you have any other||
5099|077|P|allergies. This product may contain inactive ingredients, which||
5099|078|P|can cause allergic reactions or other problems. Talk to your||
5099|079|P|pharmacist for more details.||
5099|080|P|   Before using this medication, tell your doctor or pharmacist||
5099|081|P|your medical history, especially of: personal or family history||
5099|082|P|of glaucoma (angle-closure type), Down's syndrome, brain damage||
5099|083|P|or spastic paralysis (in children).||
5099|084|P|   After you apply this drug, your vision may become temporarily||
5099|085|P|blurred. Do not drive, use machinery, or do anything that needs||
5099|086|P|clear vision until you can do it safely.||
5099|087|P|   This medication may make your eyes more sensitive to light.||
5099|088|P|Protect your eyes in bright light. Use dark sunglasses when||
5099|089|P|outdoors.||
5099|090|P|   Infants or small children may be more sensitive to the side||
5099|091|P|effects of this drug. Do not allow this medication to get into||
5099|092|P|the child's mouth. Remember to wash your hands after each use.||
5099|093|P|   During pregnancy, this medication should be used only when||
5099|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
5099|095|P|   It is unknown if this drug passes into breast milk. Consult||
5099|096|P|your doctor before breastfeeding.||
5099|097|B|||
5099|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5099|099|I|medications work or increase your risk for serious side effects.||
5099|100|I|This document does not contain all possible drug interactions.||
5099|101|I|Keep a list of all the products you use (including||
5099|102|I|prescription/nonprescription drugs and herbal products) and share||
5099|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
5099|104|I|the dosage of any medicines without your doctor's approval.||
5099|105|B|||
5099|106|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5099|107|O|has overdosed and has serious symptoms such as passing out or||
5099|108|O|trouble breathing, call 911. Otherwise, call a poison control||
5099|109|O|center right away. US residents can call 1-800-222-1222. Canada||
5099|110|O|residents can call 1-844-764-7669. Symptoms of overdose may||
5099|111|O|include: flushed/dry skin, blurred vision, fast/irregular||
5099|112|O|heartbeat, fever, mental/mood changes (such as hallucinations),||
5099|113|O|loss of coordination.||
5099|114|B|||
5099|115|N|NOTES:  Do not share this medication with others.||
5099|116|B|||
5099|117|D|MISSED DOSE:  If you are using this drug on a regular schedule||
5099|118|D|and miss a dose, use it as soon as you remember. If it is near||
5099|119|D|the time of the next dose, skip the missed dose. Use your next||
5099|120|D|dose at the regular time. Do not double the dose to catch up.||
5099|121|B|||
5099|122|R|STORAGE:  Store at room temperature away from light. Do not||
5099|123|R|freeze. Keep all medications away from children and pets.||
5099|124|R|   Do not flush medications down the toilet or pour them into a||
5099|125|R|drain unless instructed to do so. Properly discard this product||
5099|126|R|when it is expired or no longer needed. Consult your pharmacist||
5099|127|R|or local waste disposal company.||
5099|128|B|||
5099|129|A|Information last revised October 2024.||
5099|130|A|Copyright(c) 2025 First Databank, Inc.||
5099|131|B|||
5105|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5105|002|Z|does NOT have all possible information about this product. This||
5105|003|Z|information does not assure that this product is safe, effective,||
5105|004|Z|or appropriate for you. This information is not individual||
5105|005|Z|medical advice and does not substitute for the advice of your||
5105|006|Z|health care professional. Always ask your health care||
5105|007|Z|professional for complete information about this product and your||
5105|008|Z|specific health needs.||
5105|009|B|||
5105|010|T|DANTROLENE - ORAL||
5105|011|F|(DAN-trow-leen)||
5105|012|B|||
5105|013|C|COMMON BRAND NAME(S): Dantrium||
5105|014|B|||
5105|015|W|WARNING:  Rarely, dantrolene may cause very serious (possibly||
5105|016|W|fatal) liver problems. The risk is greater if you use high doses||
5105|017|W|of dantrolene (over 400-800 milligrams per day), or are female,||
5105|018|W|older than 35 years, or taking other medications. Signs of liver||
5105|019|W|problems usually appear between 3-12 months of treatment. To||
5105|020|W|reduce your risk of this side effect, you should have regular||
5105|021|W|liver tests checked by your doctor. Tell your doctor right away||
5105|022|W|if you develop any of the following symptoms of liver disease:||
5105|023|W|nausea/vomiting that doesn't stop, stomach/abdominal pain, dark||
5105|024|W|urine, yellowing eyes/skin, unusual tiredness.||
5105|025|W|   To further reduce your risk of side effects, do not increase||
5105|026|W|your dose or take it more often or for longer than prescribed.||
5105|027|W|The lowest effective dose should be used. The manufacturer||
5105|028|W|recommends that if your condition does not improve after 45 days||
5105|029|W|of treatment, your doctor must be notified and dantrolene should||
5105|030|W|be stopped.||
5105|031|B|||
5105|032|U|USES:  This medication is used to treat muscle tightness and||
5105|033|U|cramping (spasms) caused by certain nerve disorders such as||
5105|034|U|spinal cord injury, stroke, cerebral palsy, and multiple||
5105|035|U|sclerosis. It works by relaxing the muscles. Dantrolene helps||
5105|036|U|reduce muscle pain and stiffness, improves your ability to move||
5105|037|U|around, and lets you do more of your daily activities.||
5105|038|U|   Dantrolene is also used with other treatments to prevent or||
5105|039|U|treat special cases of high fever (malignant hyperthermia)||
5105|040|U|related to anesthesia and surgery.||
5105|041|B|||
5105|042|V|OTHER USES:  This section contains uses of this drug that are not||
5105|043|V|listed in the approved professional labeling for the drug but||
5105|044|V|that may be prescribed by your health care professional. Use this||
5105|045|V|drug for a condition that is listed in this section only if it||
5105|046|V|has been so prescribed by your health care professional.||
5105|047|V|   This drug may also be used for a certain uncommon condition||
5105|048|V|(neuroleptic malignant syndrome) involving muscle stiffness,||
5105|049|V|fever, and fast heartbeat caused by psychiatric medications.||
5105|050|B|||
5105|051|H|HOW TO USE:  See also Warning section.||
5105|052|H|   Take this medication by mouth as directed by your doctor. For||
5105|053|H|the treatment of long-term muscle tightness/spasms, your doctor||
5105|054|H|may slowly increase your dose to lower your chance of side||
5105|055|H|effects until the right dose for you is determined.||
5105|056|H|   The dosage is based on your medical condition, weight, and||
5105|057|H|response to treatment. For the prevention and treatment of||
5105|058|H|malignant hyperthermia, treatment lasts for several days.||
5105|059|H|   Take this medication regularly to get the most benefit from||
5105|060|H|it. To help you remember, take it at the same times each day.||
5105|061|B|||
5105|062|S|SIDE EFFECTS:  See also Warning section.||
5105|063|S|   Drowsiness, dizziness, weakness, tiredness, nausea, and||
5105|064|S|diarrhea may occur as your body adjusts to this medication and||
5105|065|S|usually lessen after several days. Headache, constipation,||
5105|066|S|trouble speaking, and drooling may also occur. If any of these||
5105|067|S|effects last or get worse, tell your doctor or pharmacist||
5105|068|S|promptly.||
5105|069|S|   Remember that this medication has been prescribed because your||
5105|070|S|doctor has judged that the benefit to you is greater than the||
5105|071|S|risk of side effects. Many people using this medication do not||
5105|072|S|have serious side effects.||
5105|073|S|   Tell your doctor right away if you have any serious side||
5105|074|S|effects, including: constipation that is severe or doesn't go||
5105|075|S|away, vision changes, black/tarry stools, vomit that looks like||
5105|076|S|coffee grounds, mental/mood changes, trouble swallowing, problems||
5105|077|S|with urination, seizures, fast heartbeat, easy bruising/bleeding,||
5105|078|S|signs of infection (such as sore throat that doesn't go away,||
5105|079|S|fever, chills), chest pain, swelling of the ankles/feet.||
5105|080|S|   A very serious allergic reaction to this drug is rare.||
5105|081|S|However, get medical help right away if you notice any symptoms||
5105|082|S|of a serious allergic reaction, including: rash, itching/swelling||
5105|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5105|084|S|breathing.||
5105|085|S|   This is not a complete list of possible side effects. If you||
5105|086|S|notice other effects not listed above, contact your doctor or||
5105|087|S|pharmacist.||
5105|088|S|   In the US -||
5105|089|S|   Call your doctor for medical advice about side effects. You||
5105|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5105|091|S|www.fda.gov/medwatch.||
5105|092|S|   In Canada - Call your doctor for medical advice about side||
5105|093|S|effects. You may report side effects to Health Canada at||
5105|094|S|1-866-234-2345.||
5105|095|B|||
5105|096|P|PRECAUTIONS:  Before taking dantrolene, tell your doctor or||
5105|097|P|pharmacist if you are allergic to it; or if you have any other||
5105|098|P|allergies. This product may contain inactive ingredients, which||
5105|099|P|can cause allergic reactions or other problems. Talk to your||
5105|100|P|pharmacist for more details.||
5105|101|P|   Before using this medication, tell your doctor or pharmacist||
5105|102|P|your medical history, especially of: liver problems (such as||
5105|103|P|hepatitis, cirrhosis), breathing problems (such as chronic||
5105|104|P|obstructive pulmonary disease-COPD), heart problems.||
5105|105|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5105|106|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5105|107|P|machinery, or do anything that needs alertness until you can do||
5105|108|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5105|109|P|are using marijuana (cannabis).||
5105|110|P|   This medication may make you more sensitive to the sun. Limit||
5105|111|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5105|112|P|sunscreen and wear protective clothing when outdoors. Tell your||
5105|113|P|doctor right away if you get sunburned or have skin||
5105|114|P|blisters/redness.||
5105|115|P|   Before having surgery, tell your doctors or dentist about all||
5105|116|P|the products you use (including prescription drugs,||
5105|117|P|nonprescription drugs, and herbal products).||
5105|118|P|   During pregnancy, this medication should be used only when||
5105|119|P|clearly needed. Discuss the risks and benefits with your doctor.||
5105|120|P|   This medication passes into breast milk. Consult your doctor||
5105|121|P|before breastfeeding.||
5105|122|B|||
5105|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5105|124|I|medications work or increase your risk for serious side effects.||
5105|125|I|This document does not contain all possible drug interactions.||
5105|126|I|Keep a list of all the products you use (including||
5105|127|I|prescription/nonprescription drugs and herbal products) and share||
5105|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
5105|129|I|the dosage of any medicines without your doctor's approval.||
5105|130|I|   Tell your doctor or pharmacist if you are taking other||
5105|131|I|products that cause drowsiness such as opioid pain or cough||
5105|132|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5105|133|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5105|134|I|lorazepam, zolpidem), other muscle relaxants (such as||
5105|135|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
5105|136|I|cetirizine, diphenhydramine).||
5105|137|I|   Check the labels on all your medicines (such as allergy or||
5105|138|I|cough-and-cold products) because they may contain ingredients||
5105|139|I|that cause drowsiness. Ask your pharmacist about using those||
5105|140|I|products safely.||
5105|141|B|||
5105|142|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5105|143|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5105|144|O|poison control center right away. US residents can call||
5105|145|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5105|146|O|Symptoms of overdose may include: severe muscle weakness, severe||
5105|147|O|tiredness, severe drowsiness.||
5105|148|B|||
5105|149|N|NOTES:  Do not share this medication with others.||
5105|150|N|   Lab and/or medical tests (such as liver function) should be||
5105|151|N|done while you are taking this medication. Keep all medical and||
5105|152|N|lab appointments. Consult your doctor for more details.||
5105|153|B|||
5105|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5105|155|D|remember. If it is near the time of the next dose, skip the||
5105|156|D|missed dose. Take your next dose at the regular time. Do not||
5105|157|D|double the dose to catch up.||
5105|158|B|||
5105|159|R|STORAGE:  Store at room temperature away from light, moisture,||
5105|160|R|and heat. Do not store in the bathroom. Keep all medications away||
5105|161|R|from children and pets.||
5105|162|R|   Do not flush medications down the toilet or pour them into a||
5105|163|R|drain unless instructed to do so. Properly discard this product||
5105|164|R|when it is expired or no longer needed. Consult your pharmacist||
5105|165|R|or local waste disposal company.||
5105|166|B|||
5105|167|A|Information last revised May 2024.||
5105|168|A|Copyright(c) 2025 First Databank, Inc.||
5105|169|B|||
5106|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5106|002|Z|does NOT have all possible information about this product. This||
5106|003|Z|information does not assure that this product is safe, effective,||
5106|004|Z|or appropriate for you. This information is not individual||
5106|005|Z|medical advice and does not substitute for the advice of your||
5106|006|Z|health care professional. Always ask your health care||
5106|007|Z|professional for complete information about this product and your||
5106|008|Z|specific health needs.||
5106|009|B|||
5106|010|T|MAGNESIUM SUPPLEMENT - ORAL||
5106|011|F|(mag-NEE-zee-um)||
5106|012|B|||
5106|013|C|COMMON BRAND NAME(S): Uro-Mag||
5106|014|B|||
5106|015|U|USES:  This medication is a mineral supplement used to prevent||
5106|016|U|and treat low amounts of magnesium in the blood. Some brands are||
5106|017|U|also used to treat symptoms of too much stomach acid such as||
5106|018|U|stomach upset, heartburn, and acid indigestion. Magnesium is very||
5106|019|U|important for the normal functioning of cells, nerves, muscles,||
5106|020|U|bones, and the heart. Usually, a well-balanced diet provides||
5106|021|U|normal blood levels of magnesium. However, certain situations||
5106|022|U|cause your body to lose magnesium faster than you can replace it||
5106|023|U|from your diet. These situations include treatment with "water||
5106|024|U|pills" (diuretics such as furosemide, hydrochlorothiazide), a||
5106|025|U|poor diet, alcoholism, or other medical conditions (such as||
5106|026|U|severe diarrhea/vomiting, stomach/intestinal absorption problems,||
5106|027|U|poorly controlled diabetes).||
5106|028|B|||
5106|029|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
5106|030|H|directions on the product package. If you have any questions, ask||
5106|031|H|your doctor or pharmacist.||
5106|032|H|   It is best to take magnesium supplements with a meal to reduce||
5106|033|H|stomach upset and diarrhea unless otherwise directed by the||
5106|034|H|product instructions or your doctor.||
5106|035|H|   Take each dose with a full glass (8 ounces or 240 milliliters)||
5106|036|H|of water unless your doctor directs you otherwise. Swallow||
5106|037|H|extended-release capsules and delayed-release/enteric coated||
5106|038|H|tablets or capsules whole. Do not crush or chew extended-release||
5106|039|H|or delayed-release/enteric coated capsules or tablets. Doing so||
5106|040|H|can release all of the drug at once, increasing the risk of side||
5106|041|H|effects. Also, do not split extended-release tablets unless they||
5106|042|H|have a score line and your doctor or pharmacist tells you to do||
5106|043|H|so. Swallow the whole or split tablet without crushing or||
5106|044|H|chewing.||
5106|045|H|   If you are taking the chewable tablets, chew each tablet||
5106|046|H|thoroughly before swallowing.||
5106|047|H|   If you are taking the rapidly-dissolving tablet, allow the||
5106|048|H|tablet to dissolve on the tongue and then swallow, with or||
5106|049|H|without water.||
5106|050|H|   If you are using a liquid product, use a medication measuring||
5106|051|H|device to carefully measure the dose. Do not use a household||
5106|052|H|spoon because you may not get the correct dose. If you are using||
5106|053|H|a suspension, shake the bottle well before each dose.||
5106|054|H|   Take this medication regularly in order to get the most||
5106|055|H|benefit from it. Remember to take it at the same time(s) each||
5106|056|H|day. The dosage is based on your medical condition and response||
5106|057|H|to treatment. Do not increase your dose or take it more often||
5106|058|H|than directed on the product package or by your doctor. Too much||
5106|059|H|magnesium in the blood can cause serious side effects.||
5106|060|H|   Tell your doctor if symptoms of low magnesium blood levels||
5106|061|H|(such as muscle cramps, tiredness, irritability, depression) last||
5106|062|H|or get worse. If you think you may have a serious medical||
5106|063|H|problem, get medical help right away.||
5106|064|B|||
5106|065|S|SIDE EFFECTS:  Stomach upset and diarrhea may occur. Taking this||
5106|066|S|product with a meal helps to reduce these effects. If either of||
5106|067|S|these effects last or get worse, tell your doctor or pharmacist||
5106|068|S|promptly.||
5106|069|S|   If your doctor has directed you to use this medication,||
5106|070|S|remember that your doctor has judged that the benefit to you is||
5106|071|S|greater than the risk of side effects. Many people using this||
5106|072|S|medication do not have serious side effects.||
5106|073|S|   A very serious allergic reaction to this drug is rare.||
5106|074|S|However, get medical help right away if you notice any symptoms||
5106|075|S|of a serious allergic reaction, including: rash, itching/swelling||
5106|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5106|077|S|breathing.||
5106|078|S|   This is not a complete list of possible side effects. If you||
5106|079|S|notice other effects not listed above, contact your doctor or||
5106|080|S|pharmacist.||
5106|081|S|   In the US -||
5106|082|S|   Call your doctor for medical advice about side effects. You||
5106|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5106|084|S|www.fda.gov/medwatch.||
5106|085|S|   In Canada - Call your doctor for medical advice about side||
5106|086|S|effects. You may report side effects to Health Canada at||
5106|087|S|1-866-234-2345.||
5106|088|B|||
5106|089|P|PRECAUTIONS:  Before taking a magnesium supplement, tell your||
5106|090|P|doctor or pharmacist if you are allergic to it; or if you have||
5106|091|P|any other allergies. This product may contain inactive||
5106|092|P|ingredients, which can cause allergic reactions or other||
5106|093|P|problems. Talk to your pharmacist for more details.||
5106|094|P|   If you have the following health problem, consult your doctor||
5106|095|P|or pharmacist before using this product: kidney disease.||
5106|096|P|   Liquids, powders, or some other forms of this product may||
5106|097|P|contain sugar and/or aspartame. Liquid products may also contain||
5106|098|P|alcohol. Caution is advised if you have diabetes, alcohol||
5106|099|P|dependence, liver disease, phenylketonuria (PKU), or any other||
5106|100|P|condition that requires you to limit/avoid these substances in||
5106|101|P|your diet. Ask your doctor or pharmacist about using this product||
5106|102|P|safely.||
5106|103|P|   Before having surgery, tell your doctor or dentist about all||
5106|104|P|the products you use (including prescription drugs,||
5106|105|P|nonprescription drugs, and herbal products).||
5106|106|P|   During pregnancy, this product should be used only when||
5106|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
5106|108|P|   It is unknown if this product passes into breast milk. Consult||
5106|109|P|your doctor before breastfeeding.||
5106|110|B|||
5106|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5106|112|I|medications work or increase your risk for serious side effects.||
5106|113|I|This document does not contain all possible drug interactions.||
5106|114|I|Keep a list of all the products you use (including||
5106|115|I|prescription/nonprescription drugs and herbal products) and share||
5106|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
5106|117|I|the dosage of any medicines without your doctor's approval.||
5106|118|I|   This product can decrease the absorption of certain drugs,||
5106|119|I|especially if you take them around the same time. These drugs||
5106|120|I|include bisphosphonates (such as alendronate), penicillamine,||
5106|121|I|quinolone antibiotics (such as ciprofloxacin, levofloxacin),||
5106|122|I|tetracycline antibiotics (such as doxycycline, minocycline),||
5106|123|I|thyroid medications (such as levothyroxine), among others. Ask||
5106|124|I|your doctor or pharmacist how long you should wait between doses||
5106|125|I|of this product and your other medications and to find a dosing||
5106|126|I|schedule that works for all your medications.||
5106|127|I|   Check the labels on all your prescription and||
5106|128|I|nonprescription/herbal products (such as antacids, laxatives,||
5106|129|I|vitamins) because they may contain magnesium. Ask your pharmacist||
5106|130|I|about using those products safely.||
5106|131|B|||
5106|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5106|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5106|134|O|poison control center right away. US residents can call||
5106|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5106|136|O|Symptoms of overdose may include slow heartbeat, severe||
5106|137|O|drowsiness, dizziness, confusion, muscle weakness, loss of||
5106|138|O|consciousness.||
5106|139|B|||
5106|140|N|NOTES:  Lab and/or medical tests (such as magnesium blood levels,||
5106|141|N|kidney function) should be done while you are taking this||
5106|142|N|medication. Keep all medical and lab appointments. Consult your||
5106|143|N|doctor for more details.||
5106|144|N|   Magnesium supplements are available in different forms with||
5106|145|N|different amounts of magnesium. Many are available without a||
5106|146|N|prescription. Ask your doctor or pharmacist for help in selecting||
5106|147|N|the best product for you.||
5106|148|N|   Eat a well-balanced diet. Foods high in magnesium include||
5106|149|N|avocados, bananas, beans, whole grain cereals, green vegetables,||
5106|150|N|and nuts.||
5106|151|B|||
5106|152|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5106|153|D|remember. If it is near the time of the next dose, skip the||
5106|154|D|missed dose. Take your next dose at the regular time. Do not||
5106|155|D|double the dose to catch up.||
5106|156|B|||
5106|157|R|STORAGE:  Store at room temperature away from light and moisture.||
5106|158|R|Do not store in the bathroom. Keep all medications away from||
5106|159|R|children and pets.||
5106|160|R|   Do not flush medications down the toilet or pour them into a||
5106|161|R|drain unless instructed to do so. Properly discard this product||
5106|162|R|when it is expired or no longer needed. Consult your pharmacist||
5106|163|R|or local waste disposal company.||
5106|164|B|||
5106|165|A|Information last revised November 2025.||
5106|166|A|Copyright(c) 2025 First Databank, Inc.||
5106|167|B|||
5108|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5108|002|Z|does NOT have all possible information about this product. This||
5108|003|Z|information does not assure that this product is safe, effective,||
5108|004|Z|or appropriate for you. This information is not individual||
5108|005|Z|medical advice and does not substitute for the advice of your||
5108|006|Z|health care professional. Always ask your health care||
5108|007|Z|professional for complete information about this product and your||
5108|008|Z|specific health needs.||
5108|009|B|||
5108|010|T|CYCLOSPORINE SOLUTION - ORAL||
5108|011|F|(SYE-kloe-SPOR-in)||
5108|012|B|||
5108|013|C|COMMON BRAND NAME(S): Sandimmune||
5108|014|B|||
5108|015|W|WARNING:  Cyclosporine lowers your ability to fight infections.||
5108|016|W|This may make you more likely to get a serious (rarely fatal)||
5108|017|W|infection or make any infection you have worse. This effect may||
5108|018|W|also increase your risk of getting certain types of cancer (such||
5108|019|W|as skin cancer, lymphoma). Tell your doctor right away if you||
5108|020|W|have any signs of infection or cancer such as sore throat that||
5108|021|W|doesn't go away, fever, chills, burning/frequent urination,||
5108|022|W|unusual skin changes, change in appearance or size of moles,||
5108|023|W|unusual weight loss, swollen lymph nodes, unusual lumps, night||
5108|024|W|sweats.||
5108|025|W|   Cyclosporine can also cause high blood pressure and kidney||
5108|026|W|problems. The risk of both problems increases with higher doses||
5108|027|W|and longer treatment with this drug. Your doctor will monitor||
5108|028|W|your blood pressure and kidney function while you take this||
5108|029|W|medication.||
5108|030|W|   Psoriasis patients who have had certain previous treatments||
5108|031|W|(such as coal tar, methotrexate, radiation treatment, light||
5108|032|W|treatment with PUVA/UVB) are at increased risk to develop skin||
5108|033|W|cancer. Talk to your doctor of the risks and benefits of this||
5108|034|W|medication.||
5108|035|W|   Different brands of this medication may deliver different||
5108|036|W|amounts of medication. Do not switch brands of cyclosporine||
5108|037|W|without your doctor's permission and directions.||
5108|038|B|||
5108|039|U|USES:  Cyclosporine is used to prevent organ rejection in people||
5108|040|U|who have received a liver, kidney, or heart transplant. It is||
5108|041|U|usually taken along with other medications to allow your new||
5108|042|U|organ to function normally. Cyclosporine belongs to a class of||
5108|043|U|drugs known as immunosuppressants. It works by weakening the||
5108|044|U|immune system to help your body accept the new organ as if it||
5108|045|U|were your own.||
5108|046|B|||
5108|047|V|OTHER USES:  This section contains uses of this drug that are not||
5108|048|V|listed in the approved professional labeling for the drug but||
5108|049|V|that may be prescribed by your health care professional. Use this||
5108|050|V|drug for a condition that is listed in this section only if it||
5108|051|V|has been so prescribed by your health care professional.||
5108|052|V|   This drug may also be used to reduce the risk of rejection in||
5108|053|V|other types of organ transplants (such as cornea, pancreas) or||
5108|054|V|bone marrow transplant. It may also be used for other conditions||
5108|055|V|that are affected by the body's immune system (such as Crohn's||
5108|056|V|disease, rheumatoid arthritis, plaque psoriasis).||
5108|057|B|||
5108|058|H|HOW TO USE:  Take this medication by mouth as directed by your||
5108|059|H|doctor, usually once daily. You may take this medication with or||
5108|060|H|without food, but it is important to choose one way and take this||
5108|061|H|medication the same way with every dose.||
5108|062|H|   The dosage is based on your weight, medical condition, lab||
5108|063|H|tests, and response to treatment.||
5108|064|H|   Carefully measure the dose using the medicine syringe||
5108|065|H|provided. Do not use a household spoon because you may not get||
5108|066|H|the correct dose. To help improve the taste, you should mix the||
5108|067|H|measured dose with a glass of milk, chocolate milk, or orange||
5108|068|H|juice that is at room temperature. Do not switch the liquid you||
5108|069|H|use often. Make sure to use a glass cup and not a plastic cup.||
5108|070|H|Drink all of the mixture right away. Do not prepare a supply in||
5108|071|H|advance. To make sure you have taken all of the medication, rinse||
5108|072|H|the glass with more liquid, then mix and drink. Consult your||
5108|073|H|pharmacist if you have any questions.||
5108|074|H|   Dry the outside of the syringe after use. Do not rinse it with||
5108|075|H|water. If the syringe must be cleaned, make sure that it is||
5108|076|H|completely dry before using it again.||
5108|077|H|   Avoid eating grapefruit or drinking grapefruit juice while||
5108|078|H|using this medication unless your doctor or pharmacist says you||
5108|079|H|may do so safely. Grapefruit can increase the chance of side||
5108|080|H|effects with this medicine. Ask your doctor or pharmacist for||
5108|081|H|more details.||
5108|082|H|   Use this medication regularly to get the most benefit from it.||
5108|083|H|To help you remember, take it at the same time each day.||
5108|084|B|||
5108|085|S|SIDE EFFECTS:  See also Warning section.||
5108|086|S|   Shaking, headache, dizziness, unusual growth of body hair,||
5108|087|S|nausea/vomiting, diarrhea, stomach upset, or flushing may occur.||
5108|088|S|If any of these effects last or get worse, tell your doctor or||
5108|089|S|pharmacist promptly.||
5108|090|S|   Unusual growth and swelling of the gums may occur. Brush your||
5108|091|S|teeth and floss daily to reduce this problem. See your dentist||
5108|092|S|regularly.||
5108|093|S|   Remember that this medication has been prescribed because your||
5108|094|S|doctor has judged that the benefit to you is greater than the||
5108|095|S|risk of side effects. Many people using this medication do not||
5108|096|S|have serious side effects.||
5108|097|S|   This medication may raise your blood pressure. Check your||
5108|098|S|blood pressure regularly and tell your doctor if the results are||
5108|099|S|high. Your doctor may control your blood pressure with||
5108|100|S|medication.||
5108|101|S|   Tell your doctor right away if you have any serious side||
5108|102|S|effects, including: signs of kidney problems (such as a change in||
5108|103|S|the amount of urine), signs of liver disease (such as||
5108|104|S|nausea/vomiting that doesn't stop, dark urine, yellowing||
5108|105|S|eyes/skin, stomach/abdominal pain), easy bruising/bleeding,||
5108|106|S|unusual tiredness, muscle weakness/spasms, slow/irregular||
5108|107|S|heartbeat, numb/tingling skin, severe leg pain.||
5108|108|S|   Get medical help right away if you have any very serious side||
5108|109|S|effects, including: mental/mood changes (such as confusion,||
5108|110|S|difficulty concentrating), vision changes, problems with speech,||
5108|111|S|clumsiness, loss of coordination, weakness on one side of the||
5108|112|S|body, chest pain, seizures.||
5108|113|S|   A very serious allergic reaction to this drug is rare.||
5108|114|S|However, get medical help right away if you notice any symptoms||
5108|115|S|of a serious allergic reaction, including: rash, itching/swelling||
5108|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5108|117|S|breathing.||
5108|118|S|   This is not a complete list of possible side effects. If you||
5108|119|S|notice other effects not listed above, contact your doctor or||
5108|120|S|pharmacist.||
5108|121|S|   In the US -||
5108|122|S|   Call your doctor for medical advice about side effects. You||
5108|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5108|124|S|www.fda.gov/medwatch.||
5108|125|S|   In Canada - Call your doctor for medical advice about side||
5108|126|S|effects. You may report side effects to Health Canada at||
5108|127|S|1-866-234-2345.||
5108|128|B|||
5108|129|P|PRECAUTIONS:  Before taking cyclosporine, tell your doctor or||
5108|130|P|pharmacist if you are allergic to it; or if you have any other||
5108|131|P|allergies. This product may contain inactive ingredients, which||
5108|132|P|can cause allergic reactions or other problems. Talk to your||
5108|133|P|pharmacist for more details.||
5108|134|P|   Before using this medication, tell your doctor or pharmacist||
5108|135|P|your medical history, especially of: kidney disease, liver||
5108|136|P|disease, high blood pressure, cancer, skin lesions of unknown||
5108|137|P|cause, radiation treatment (including light treatment with PUVA||
5108|138|P|or UVB), mineral imbalance (such as low level of magnesium or||
5108|139|P|high level of potassium), recent/current infections, high||
5108|140|P|cholesterol/triglycerides levels.||
5108|141|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5108|142|P|can make you more dizzy. Do not drive, use machinery, or do||
5108|143|P|anything that needs alertness until you can do it safely. Limit||
5108|144|P|alcoholic beverages. Talk to your doctor if you are using||
5108|145|P|marijuana (cannabis).||
5108|146|P|   This medication may contain alcohol. Caution is advised if you||
5108|147|P|are pregnant or breastfeeding or have liver disease, alcohol||
5108|148|P|dependence, or any other condition that requires you to||
5108|149|P|limit/avoid alcohol in your diet. Ask your doctor or pharmacist||
5108|150|P|about using this product safely.||
5108|151|P|   Cyclosporine can make you more likely to get infections or may||
5108|152|P|make current infections worse. Stay away from anyone who has an||
5108|153|P|infection that may easily spread (such as chickenpox, COVID-19,||
5108|154|P|measles, flu). Talk to your doctor if you have been exposed to an||
5108|155|P|infection or for more details.||
5108|156|P|   Tell your health care professional that you are using||
5108|157|P|cyclosporine before having any immunizations/vaccinations. Avoid||
5108|158|P|contact with people who have recently received live vaccines||
5108|159|P|(such as flu vaccine inhaled through the nose).||
5108|160|P|   This medication may increase your risk of developing skin||
5108|161|P|cancer. Limit your time in the sun. Avoid tanning booths and||
5108|162|P|sunlamps. Use sunscreen and wear protective clothing when||
5108|163|P|outdoors. Your doctor may direct you to avoid phototherapy while||
5108|164|P|you use this product. Ask your doctor for details.||
5108|165|P|   This product may increase your potassium levels. Before using||
5108|166|P|potassium supplements or salt substitutes that contain potassium,||
5108|167|P|consult your doctor or pharmacist.||
5108|168|P|   Before having surgery, tell your doctor or dentist about all||
5108|169|P|the products you use (including prescription drugs,||
5108|170|P|nonprescription drugs, and herbal products).||
5108|171|P|   Older adults may be at greater risk for kidney problems or||
5108|172|P|high blood pressure while using this drug.||
5108|173|P|   During pregnancy, this medication should be used only when||
5108|174|P|clearly needed. It may harm an unborn baby or cause other||
5108|175|P|problems with the baby such as being born too early (premature)||
5108|176|P|or having low birth weight. Discuss the risks and benefits with||
5108|177|P|your doctor.||
5108|178|P|   This medication passes into breast milk. Consult your doctor||
5108|179|P|before breastfeeding.||
5108|180|B|||
5108|181|I|DRUG INTERACTIONS:  See also How to Use section.||
5108|182|I|   Drug interactions may change how your medications work or||
5108|183|I|increase your risk for serious side effects. This document does||
5108|184|I|not contain all possible drug interactions. Keep a list of all||
5108|185|I|the products you use (including prescription/nonprescription||
5108|186|I|drugs and herbal products) and share it with your doctor and||
5108|187|I|pharmacist. Do not start, stop, or change the dosage of any||
5108|188|I|medicines without your doctor's approval.||
5108|189|I|   Some products that may interact with this drug include: coal||
5108|190|I|tar, orlistat, other drugs that weaken the immune system/increase||
5108|191|I|the risk of infection (such as natalizumab, rituximab,||
5108|192|I|tofacitinib), drugs that may increase potassium levels (such as||
5108|193|I|potassium supplements, certain diuretics/"water pills" including||
5108|194|I|amiloride, spironolactone), tacrolimus.||
5108|195|I|   Other medications can affect the removal of cyclosporine from||
5108|196|I|your body, which may affect how cyclosporine works. Examples||
5108|197|I|include bosentan, mifepristone, St. John's wort, ritonavir, among||
5108|198|I|others.||
5108|199|I|   This medication can slow down the removal of other medications||
5108|200|I|from your body, which may affect how they work. Examples of||
5108|201|I|affected drugs include aliskiren, dabigatran, dronedarone,||
5108|202|I|elagolix, resmetirom, certain statins (such as pitavastatin,||
5108|203|I|simvastatin), voxilaprevir, among others.||
5108|204|B|||
5108|205|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5108|206|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5108|207|O|poison control center right away. US residents can call||
5108|208|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5108|209|B|||
5108|210|N|NOTES:  Do not share this medication with others.||
5108|211|N|   Lab and/or medical tests (such as kidney/liver function, blood||
5108|212|N|pressure, blood mineral levels, cyclosporine blood levels,||
5108|213|N|complete blood count, uric acid levels, lipid levels, skin exam)||
5108|214|N|should be done while you are taking this medication. Keep all||
5108|215|N|medical and lab appointments. Consult your doctor for more||
5108|216|N|details.||
5108|217|N|   If you have had an organ transplant, it is recommended that||
5108|218|N|you attend a transplant education class or support group. Learn||
5108|219|N|the symptoms of organ rejection such as a feeling of being ill,||
5108|220|N|fever, pain around the transplanted organ, and signs of a failing||
5108|221|N|transplanted organ (a decrease in the amount of urine with kidney||
5108|222|N|transplant, yellowing of the skin/eyes with liver transplant,||
5108|223|N|shortness of breath/inability to exercise with heart transplant).||
5108|224|N|Get medical help right away if these symptoms of rejection occur.||
5108|225|B|||
5108|226|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5108|227|D|remember. If it is near the time of the next dose, skip the||
5108|228|D|missed dose. Take your next dose at the regular time. Do not||
5108|229|D|double the dose to catch up.||
5108|230|B|||
5108|231|R|STORAGE:  Store in the original bottle at room temperature. Do||
5108|232|R|not refrigerate or freeze. Once the bottle has been opened, the||
5108|233|R|medication expires after 2 months. Do not store in the bathroom.||
5108|234|R|Keep all medications away from children and pets.||
5108|235|R|   Do not flush medications down the toilet or pour them into a||
5108|236|R|drain unless instructed to do so. Properly discard this product||
5108|237|R|when it is expired or no longer needed. Consult your pharmacist||
5108|238|R|or local waste disposal company.||
5108|239|B|||
5108|240|M|MEDICAL ALERT:  Your condition can cause complications in a||
5108|241|M|medical emergency. For information about enrolling in MedicAlert,||
5108|242|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5108|243|B|||
5108|244|A|Information last revised May 2025.||
5108|245|A|Copyright(c) 2025 First Databank, Inc.||
5108|246|B|||
5112|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5112|002|Z|does NOT have all possible information about this product. This||
5112|003|Z|information does not assure that this product is safe, effective,||
5112|004|Z|or appropriate for you. This information is not individual||
5112|005|Z|medical advice and does not substitute for the advice of your||
5112|006|Z|health care professional. Always ask your health care||
5112|007|Z|professional for complete information about this product and your||
5112|008|Z|specific health needs.||
5112|009|B|||
5112|010|T|DESMOPRESSIN - INJECTION||
5112|011|F|(dess-mow-PRESS-in)||
5112|012|B|||
5112|013|C|COMMON BRAND NAME(S): DDAVP||
5112|014|B|||
5112|015|W|WARNING:  Desmopressin can rarely cause a low level of sodium in||
5112|016|W|the blood (hyponatremia), which can be serious or even fatal.||
5112|017|W|Drinking too much liquid, using certain medications (such as||
5112|018|W|"water pills"/diuretics including furosemide, corticosteroids||
5112|019|W|such as prednisone), being 65 years or older, or having certain||
5112|020|W|medical conditions may increase the risk of low sodium in the||
5112|021|W|blood. Lab tests (such as urine tests, sodium blood levels) must||
5112|022|W|be done before you start using this medication and while you are||
5112|023|W|using it. Keep all medical and lab appointments.||
5112|024|W|   Tell your doctor right away if you develop symptoms of low||
5112|025|W|sodium in the blood, such as nausea, vomiting, headache, muscle||
5112|026|W|weakness/cramps, unusual tiredness, unusual drowsiness,||
5112|027|W|dizziness, restlessness, mental/mood changes including||
5112|028|W|confusion/irritability.||
5112|029|W|   Get medical help right away if you have any very serious side||
5112|030|W|effects, including seizure or trouble breathing.||
5112|031|B|||
5112|032|U|USES:  Desmopressin is used to control the amount of urine your||
5112|033|U|kidneys make. Normally, the amount of urine you make is||
5112|034|U|controlled by a certain substance in the body called vasopressin.||
5112|035|U|In people who have "water diabetes" (diabetes insipidus) or||
5112|036|U|certain kinds of head injury or brain surgery, the body does not||
5112|037|U|make enough vasopressin. Desmopressin is a man-made form of||
5112|038|U|vasopressin and is used to replace a low level of vasopressin.||
5112|039|U|This medication helps to control increased thirst and too much||
5112|040|U|urination due to these conditions, and helps prevent dehydration.||
5112|041|U|   Desmopressin is also used to control bleeding caused by||
5112|042|U|surgery or injuries in people with certain bleeding problems||
5112|043|U|(hemophilia A, type 1 von Willebrand's disease). It works by||
5112|044|U|helping the body with normal blood clotting.||
5112|045|B|||
5112|046|H|HOW TO USE:  When this medication is used to control bleeding, it||
5112|047|H|is given by injection into a vein by a health care professional.||
5112|048|H|It is given as directed by your doctor, usually over 15 to 30||
5112|049|H|minutes.||
5112|050|H|   When this medication is used to control increased thirst and||
5112|051|H|too much urination, it is given by injection into a vein or under||
5112|052|H|the skin as directed by your doctor, usually twice a day.||
5112|053|H|   The dosage is based on your medical condition and response to||
5112|054|H|treatment. Do not use more desmopressin or use it more often than||
5112|055|H|prescribed.||
5112|056|H|   If you are using this medication at home, learn all||
5112|057|H|preparation and usage instructions from your health care||
5112|058|H|professional. Before using, check this product for particles or||
5112|059|H|discoloration. If either is present, do not use the liquid. Learn||
5112|060|H|how to store and discard medical supplies safely.||
5112|061|H|   Use this medication regularly to get the most benefit from it.||
5112|062|H|To help you remember, use it at the same times each day.||
5112|063|H|   Limit drinking of water and other fluids while using this||
5112|064|H|medication, especially in children and older adults. Consult your||
5112|065|H|doctor for details. If you find that you are drinking more fluids||
5112|066|H|than directed, tell your doctor right away. Your treatment will||
5112|067|H|need to be adjusted.||
5112|068|H|   Tell your doctor if your condition does not get better or if||
5112|069|H|this medication stops working well.||
5112|070|B|||
5112|071|S|SIDE EFFECTS:  See also Warning section.||
5112|072|S|   Headache, nausea, upset stomach, flushing of the face, or||
5112|073|S|redness/pain/swelling at the injection site may occur. If any of||
5112|074|S|these effects last or get worse, tell your doctor or pharmacist||
5112|075|S|promptly.||
5112|076|S|   Rarely, desmopressin may affect your blood pressure. It may||
5112|077|S|cause an increase or decrease in your blood pressure. A temporary||
5112|078|S|drop in your blood pressure may result in dizziness and a fast||
5112|079|S|heartbeat. Ask your doctor for more details, especially if you||
5112|080|S|have heart problems or high or low blood pressure. Tell your||
5112|081|S|doctor promptly if changes in your blood pressure occur or if any||
5112|082|S|of these symptoms occur.||
5112|083|S|   Remember that this medication has been prescribed because your||
5112|084|S|doctor has judged that the benefit to you is greater than the||
5112|085|S|risk of side effects. Many people using this medication do not||
5112|086|S|have serious side effects.||
5112|087|S|   A very serious allergic reaction to this drug is rare.||
5112|088|S|However, get medical help right away if you notice any symptoms||
5112|089|S|of a serious allergic reaction, including: rash, itching/swelling||
5112|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5112|091|S|breathing.||
5112|092|S|   This is not a complete list of possible side effects. If you||
5112|093|S|notice other effects not listed above, contact your doctor or||
5112|094|S|pharmacist.||
5112|095|S|   In the US -||
5112|096|S|   Call your doctor for medical advice about side effects. You||
5112|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5112|098|S|www.fda.gov/medwatch.||
5112|099|S|   In Canada - Call your doctor for medical advice about side||
5112|100|S|effects. You may report side effects to Health Canada at||
5112|101|S|1-866-234-2345.||
5112|102|B|||
5112|103|P|PRECAUTIONS:  Before using desmopressin, tell your doctor or||
5112|104|P|pharmacist if you are allergic to it; or if you have any other||
5112|105|P|allergies. This product may contain inactive ingredients, which||
5112|106|P|can cause allergic reactions or other problems. Talk to your||
5112|107|P|pharmacist for more details.||
5112|108|P|   Before using this medication, tell your doctor or pharmacist||
5112|109|P|your medical history, especially of: kidney disease, high or low||
5112|110|P|blood pressure, heart problems (such as blocked blood vessels,||
5112|111|P|heart failure), conditions that may increase your risk of||
5112|112|P|fluid/mineral imbalance (such as cystic fibrosis), the urge to||
5112|113|P|drink too much water without being thirsty, a low level of sodium||
5112|114|P|in the blood (hyponatremia), history of blood clots.||
5112|115|P|   If you become dehydrated, your doctor will correct that||
5112|116|P|condition first before starting treatment with desmopressin.||
5112|117|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5112|118|P|can make you more dizzy. Do not drive, use machinery, or do||
5112|119|P|anything that needs alertness until you can do it safely. Limit||
5112|120|P|alcoholic beverages. Talk to your doctor if you are using||
5112|121|P|marijuana (cannabis). Alcohol can also interfere with how well||
5112|122|P|desmopressin works.||
5112|123|P|   Tell the doctor right away if you develop any illness that can||
5112|124|P|cause water/mineral imbalance (including fever, diarrhea,||
5112|125|P|vomiting, infections such as the flu) or if you experience||
5112|126|P|conditions that require drinking more fluids (for example,||
5112|127|P|exposure to very hot weather, strenuous exercise, heavy||
5112|128|P|sweating). The doctor may need to stop or adjust desmopressin||
5112|129|P|treatment, especially in children and older adults.||
5112|130|P|   Before having surgery, tell your doctor or dentist about all||
5112|131|P|the products you use (including prescription drugs,||
5112|132|P|nonprescription drugs, and herbal products).||
5112|133|P|   Children may be more sensitive to the side effects of this||
5112|134|P|drug, especially water/mineral imbalance and a low level of||
5112|135|P|sodium in the blood.||
5112|136|P|   Older adults may be at greater risk for water/mineral||
5112|137|P|imbalance and a low level of sodium in the blood while using this||
5112|138|P|drug.||
5112|139|P|   During pregnancy, this medication should be used only when||
5112|140|P|clearly needed. Discuss the risks and benefits with your doctor.||
5112|141|P|   This medication passes into breast milk. Consult your doctor||
5112|142|P|before breastfeeding.||
5112|143|B|||
5112|144|I|DRUG INTERACTIONS:  See also Warning section.||
5112|145|I|   Drug interactions may change how your medications work or||
5112|146|I|increase your risk for serious side effects. This document does||
5112|147|I|not contain all possible drug interactions. Keep a list of all||
5112|148|I|the products you use (including prescription/nonprescription||
5112|149|I|drugs and herbal products) and share it with your doctor and||
5112|150|I|pharmacist. Do not start, stop, or change the dosage of any||
5112|151|I|medicines without your doctor's approval.||
5112|152|I|   Some products that may interact with this drug are:||
5112|153|I|corticosteroids that are taken by mouth or inhaled (such as||
5112|154|I|fluticasone, prednisone), tolvaptan, "water pills"/diuretics||
5112|155|I|(such as furosemide).||
5112|156|B|||
5112|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5112|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5112|159|O|poison control center right away. US residents can call||
5112|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5112|161|O|Symptoms of overdose may include: headache that is severe or||
5112|162|O|doesn't go away, confusion, drowsiness, sudden weight gain.||
5112|163|B|||
5112|164|N|NOTES:  Do not share this medication with others.||
5112|165|N|   Lab and/or medical tests (such as urine tests, sodium blood||
5112|166|N|level, blood pressure, pulse) may be done while you are using||
5112|167|N|this medication. Keep all medical and lab appointments. Consult||
5112|168|N|your doctor for more details.||
5112|169|B|||
5112|170|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5112|171|D|If it is near the time of the next dose, skip the missed dose.||
5112|172|D|Use your next dose at the regular time. Do not double the dose to||
5112|173|D|catch up.||
5112|174|B|||
5112|175|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
5112|176|R|medications away from children and pets.||
5112|177|R|   Do not flush medications down the toilet or pour them into a||
5112|178|R|drain unless instructed to do so. Properly discard this product||
5112|179|R|when it is expired or no longer needed. Consult your pharmacist||
5112|180|R|or local waste disposal company.||
5112|181|B|||
5112|182|A|Information last revised November 2024.||
5112|183|A|Copyright(c) 2025 First Databank, Inc.||
5112|184|B|||
5115|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5115|002|Z|does NOT have all possible information about this product. This||
5115|003|Z|information does not assure that this product is safe, effective,||
5115|004|Z|or appropriate for you. This information is not individual||
5115|005|Z|medical advice and does not substitute for the advice of your||
5115|006|Z|health care professional. Always ask your health care||
5115|007|Z|professional for complete information about this product and your||
5115|008|Z|specific health needs.||
5115|009|B|||
5115|010|T|ETHINYL ESTRADIOL/DROSPIRENONE - ORAL||
5115|011|F|(ETH-in-il ess-tra-DYE-ole/droh-SPYE-re-none)||
5115|012|B|||
5115|013|C|COMMON BRAND NAME(S): Yasmin 28||
5115|014|B|||
5115|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
5115|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
5115|017|W|stroke, heart attack, blood clots, and high blood pressure from||
5115|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
5115|019|W|of these serious problems increases with age and with the number||
5115|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
5115|021|B|||
5115|022|U|USES:  This medication is a combination of 2 hormones: an||
5115|023|U|estrogen (ethinyl estradiol) and a progestin (drospirenone). This||
5115|024|U|product is used to prevent pregnancy.||
5115|025|U|   Besides preventing pregnancy, birth control pills may make||
5115|026|U|your periods more regular, decrease blood loss and painful||
5115|027|U|periods, and decrease your risk of ovarian cysts.||
5115|028|U|   This medication does not protect against sexually transmitted||
5115|029|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
5115|030|U|an effective barrier method (latex or polyurethane condom/dental||
5115|031|U|dams) during sexual activity will help to decrease your risk of||
5115|032|U|infection.||
5115|033|B|||
5115|034|V|OTHER USES:  This section contains uses of this drug that are not||
5115|035|V|listed in the approved US professional labeling for the drug but||
5115|036|V|that may be prescribed by your health care professional. Use this||
5115|037|V|drug for a condition that is listed in this section only if it||
5115|038|V|has been so prescribed by your health care professional.||
5115|039|V|   Birth control pills may also be used for premenstrual||
5115|040|V|dysphoric disorder (PMDD) or moderate acne if you have chosen to||
5115|041|V|use birth control pills as your method of pregnancy prevention.||
5115|042|B|||
5115|043|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
5115|044|H|your pharmacist before you start using this product and each time||
5115|045|H|you get a refill. The leaflet contains very important information||
5115|046|H|on when to take your pills and what to do if you miss a dose. If||
5115|047|H|you have any questions, ask your doctor or pharmacist.||
5115|048|H|   Take this medication by mouth as directed by your doctor, with||
5115|049|H|or without food, usually once daily. Pick a time of day that is||
5115|050|H|easy for you to remember, and take your pill at the same time||
5115|051|H|each day, 24 hours apart. Taking this medication after your||
5115|052|H|evening meal or at bedtime may help decrease stomach upset and||
5115|053|H|nausea.||
5115|054|H|   Follow the package instructions to find the first tablet,||
5115|055|H|start with the first tablet in the pack, and take them in the||
5115|056|H|correct order. Do not skip any doses. Pregnancy is more likely if||
5115|057|H|you miss pills, start a new pack late, or take your pill at a||
5115|058|H|different time of the day than usual.||
5115|059|H|   Vomiting or diarrhea can prevent your birth control pills from||
5115|060|H|working well. If you have vomiting or diarrhea, you may need to||
5115|061|H|use a backup birth control method (such as condoms, spermicide).||
5115|062|H|Follow the directions in the Patient Information Leaflet and||
5115|063|H|check with your doctor or pharmacist for more details.||
5115|064|H|   Your pill pack contains 21 pills with active medication (with||
5115|065|H|hormones). It may also contain 7 reminder pills (without||
5115|066|H|hormones) at the end of the pack. Take one active pill (with||
5115|067|H|hormones) once daily for 21 days in a row. If you are using a||
5115|068|H|product with 28 tablets, take a reminder pill once daily for 7||
5115|069|H|days in a row after you have taken the last active pill unless||
5115|070|H|otherwise directed by your doctor. If you are using a product||
5115|071|H|with 21 tablets, do not take any tablets for 7 days unless||
5115|072|H|otherwise directed by your doctor. You should have your period||
5115|073|H|usually within 3 days after you take the last active tablet in||
5115|074|H|the cycle. After you have taken the last reminder pill in the||
5115|075|H|pack or gone 7 days without taking an active tablet, start a new||
5115|076|H|pack the next day whether or not you have your period. If you do||
5115|077|H|not get your period, consult your doctor.||
5115|078|H|   If this is the first time you are using this medication and||
5115|079|H|you are not switching from another form of hormonal birth control||
5115|080|H|(such as patch, other birth control pills), take the first tablet||
5115|081|H|in the pack on the first Sunday following the beginning of your||
5115|082|H|menstrual period or on the first day of your period. If your||
5115|083|H|period begins on a Sunday, begin taking this medication on that||
5115|084|H|day. For the first cycle of use only, use a backup form of||
5115|085|H|non-hormonal birth control (such as condoms, spermicide) for the||
5115|086|H|first 7 days to prevent pregnancy until the medication has enough||
5115|087|H|time to work. If you start on the first day of your period, you||
5115|088|H|do not need to use backup birth control the first week.||
5115|089|H|   Ask your doctor or pharmacist for information about how to||
5115|090|H|switch from other forms of hormonal birth control (such as the||
5115|091|H|patch, other birth control pills) to this product.||
5115|092|B|||
5115|093|S|SIDE EFFECTS:  Nausea, vomiting, headache, bloating, breast||
5115|094|S|tenderness, swelling of the ankles/feet (fluid retention), or||
5115|095|S|weight change may occur. Vaginal bleeding between periods||
5115|096|S|(spotting) or missed/irregular periods may occur, especially||
5115|097|S|during the first few months of use. If any of these effects last||
5115|098|S|or get worse, tell your doctor promptly. If you miss 2 periods in||
5115|099|S|a row (or 1 period if the pill has not been used properly),||
5115|100|S|contact your doctor for a pregnancy test.||
5115|101|S|   Remember that this medication has been prescribed because your||
5115|102|S|doctor has judged that the benefit to you is greater than the||
5115|103|S|risk of side effects. Many people using this medication do not||
5115|104|S|have serious side effects.||
5115|105|S|   This medication may raise your blood pressure. Check your||
5115|106|S|blood pressure regularly and tell your doctor if the results are||
5115|107|S|high.||
5115|108|S|   Tell your doctor right away if you have any serious side||
5115|109|S|effects, including: unusual changes in vaginal bleeding (such as||
5115|110|S|continuous spotting, sudden heavy bleeding, missed periods),||
5115|111|S|symptoms of a high potassium blood level (such as muscle||
5115|112|S|weakness, slow/irregular heartbeat).||
5115|113|S|   This medication may rarely cause serious (sometimes fatal)||
5115|114|S|problems from blood clots (such as heart attack, stroke, blood||
5115|115|S|clots in the lungs or legs). Get medical help right away if you||
5115|116|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
5115|117|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
5115|118|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
5115|119|S|trouble speaking, weakness on one side of the body, sudden vision||
5115|120|S|changes.||
5115|121|S|   Get medical help right away if you have any very serious side||
5115|122|S|effects, including: lumps in the breast, severe stomach/abdominal||
5115|123|S|pain, dark urine, yellowing eyes/skin, mental/mood changes (such||
5115|124|S|as new/worsening depression, suicidal thoughts).||
5115|125|S|   A very serious allergic reaction to this drug is rare.||
5115|126|S|However, get medical help right away if you notice any symptoms||
5115|127|S|of a serious allergic reaction, including: rash, itching/swelling||
5115|128|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5115|129|S|breathing.||
5115|130|S|   This is not a complete list of possible side effects. If you||
5115|131|S|notice other effects not listed above, contact your doctor or||
5115|132|S|pharmacist.||
5115|133|S|   In the US -||
5115|134|S|   Call your doctor for medical advice about side effects. You||
5115|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5115|136|S|www.fda.gov/medwatch.||
5115|137|S|   In Canada - Call your doctor for medical advice about side||
5115|138|S|effects. You may report side effects to Health Canada at||
5115|139|S|1-866-234-2345.||
5115|140|B|||
5115|141|P|PRECAUTIONS:  See also Warning section.||
5115|142|P|   Before using this medication, tell your doctor or pharmacist||
5115|143|P|if you are allergic to ethinyl estradiol or drospirenone; or to||
5115|144|P|other estrogens or progestins; or if you have any other||
5115|145|P|allergies. This product may contain inactive ingredients, which||
5115|146|P|can cause allergic reactions or other problems. Talk to your||
5115|147|P|pharmacist for more details.||
5115|148|P|   Before using this product, tell your doctor or pharmacist your||
5115|149|P|medical history, especially of: adrenal gland problems, stroke,||
5115|150|P|blood clots (such as in the legs, eyes, lungs), high blood||
5115|151|P|pressure, abnormal breast exam, cancer (especially endometrial or||
5115|152|P|breast cancer), blood clotting disorders (such as protein C or||
5115|153|P|protein S deficiency), diabetes that has caused||
5115|154|P|kidney/eye/nerve/blood vessel disease, severe||
5115|155|P|headaches/migraines, family or personal history of a certain||
5115|156|P|swelling disorder (angioedema), heart problems (such as heart||
5115|157|P|valve disease, irregular heartbeat, previous heart attack),||
5115|158|P|kidney problems, liver problems (such as liver tumor, active||
5115|159|P|liver disease), history of yellowing eyes/skin (jaundice) during||
5115|160|P|pregnancy or while using birth control pills, unexplained vaginal||
5115|161|P|bleeding, high cholesterol or triglyceride (blood fat) levels,||
5115|162|P|depression, swelling (edema), gallbladder problems, obesity.||
5115|163|P|   If you have diabetes, this medication may affect your blood||
5115|164|P|sugar. Check your blood sugar regularly as directed and share the||
5115|165|P|results with your doctor. Tell your doctor right away if you have||
5115|166|P|symptoms of high blood sugar such as increased thirst/urination.||
5115|167|P|Your doctor may need to adjust your diabetes medication, exercise||
5115|168|P|program, or diet.||
5115|169|P|   Tell your doctor if you just had or will be having major||
5115|170|P|surgery, or if you will be confined to a chair or bed for a long||
5115|171|P|time (such as a long plane flight). These conditions increase||
5115|172|P|your risk of getting blood clots, especially if you are taking||
5115|173|P|hormonal birth control products. You may need to stop this||
5115|174|P|medication for a time or take special precautions.||
5115|175|P|   Before having surgery, tell your doctor or dentist about all||
5115|176|P|the products you use (including prescription drugs,||
5115|177|P|nonprescription drugs, and herbal products).||
5115|178|P|   This product may increase your potassium levels. Before using||
5115|179|P|potassium supplements or salt substitutes that contain potassium,||
5115|180|P|consult your doctor or pharmacist.||
5115|181|P|   This medication may cause blotchy, dark areas on your face and||
5115|182|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
5115|183|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
5115|184|P|wear protective clothing when outdoors.||
5115|185|P|   If you are nearsighted or wear contact lenses, you may develop||
5115|186|P|vision problems or trouble wearing your contact lenses. Contact||
5115|187|P|your eye doctor if these problems occur.||
5115|188|P|   It may take longer for you to become pregnant after you stop||
5115|189|P|taking birth control pills. Consult your doctor.||
5115|190|P|   This medication should not be used during pregnancy. If you||
5115|191|P|become pregnant or think you may be pregnant, tell your doctor||
5115|192|P|right away. If you have just given birth or had a pregnancy||
5115|193|P|loss/abortion after the first 3 months, talk with your doctor||
5115|194|P|about reliable forms of birth control, and find out when it is||
5115|195|P|safe to start using birth control that contains a form of||
5115|196|P|estrogen, such as this medication.||
5115|197|P|   This medication passes into breast milk and may harm a nursing||
5115|198|P|infant. Consult your doctor before breastfeeding.||
5115|199|B|||
5115|200|I|DRUG INTERACTIONS:  See also Precautions section.||
5115|201|I|   Drug interactions may change how your medications work or||
5115|202|I|increase your risk for serious side effects. This document does||
5115|203|I|not contain all possible drug interactions. Keep a list of all||
5115|204|I|the products you use (including prescription/nonprescription||
5115|205|I|drugs and herbal products) and share it with your doctor and||
5115|206|I|pharmacist. Do not start, stop, or change the dosage of any||
5115|207|I|medicines without your doctor's approval.||
5115|208|I|   Some products that may interact with this drug include:||
5115|209|I|aromatase inhibitors (such as anastrozole, exemestane),||
5115|210|I|atazanavir/cobicistat, fezolinetant, fosamprenavir, ospemifene,||
5115|211|I|tamoxifen, tizanidine, tranexamic acid.||
5115|212|I|   Drospirenone may raise your potassium blood level. Tell your||
5115|213|I|doctor if you are regularly taking other drugs/products that can||
5115|214|I|also raise your potassium level (including aliskiren, ACE||
5115|215|I|inhibitors such as enalapril/lisinopril, angiotensin receptor||
5115|216|I|blockers such as losartan/valsartan, heparin, NSAIDs such as||
5115|217|I|ibuprofen/naproxen, potassium-sparing "water pills"/diuretics||
5115|218|I|such as eplerenone/spironolactone/triamterene).||
5115|219|I|   Some drugs may cause hormonal birth control to work less well||
5115|220|I|by decreasing the amount of birth control hormones in your body.||
5115|221|I|This effect can result in pregnancy. Examples of these drugs||
5115|222|I|include griseofulvin, modafinil, rifamycins (such as rifampin),||
5115|223|I|ritonavir, St. John's wort, drugs used to treat seizures (such as||
5115|224|I|barbiturates, carbamazepine, felbamate, phenytoin, primidone,||
5115|225|I|topiramate), HIV drugs (such as nelfinavir, nevirapine), among||
5115|226|I|others. Ask your doctor or pharmacist for more details.||
5115|227|I|   Tell your doctor when you start any new drug, and discuss if||
5115|228|I|you should use reliable backup birth control. Also tell your||
5115|229|I|doctor if you have any new spotting or breakthrough bleeding,||
5115|230|I|because these may be signs that your birth control is not working||
5115|231|I|well.||
5115|232|I|   This medication may interfere with certain lab tests, possibly||
5115|233|I|causing false test results. Make sure lab personnel and all your||
5115|234|I|doctors know you use this drug.||
5115|235|B|||
5115|236|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5115|237|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5115|238|O|poison control center right away. US residents can call||
5115|239|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5115|240|O|Symptoms of overdose may include: severe nausea and vomiting,||
5115|241|O|sudden/unusual vaginal bleeding.||
5115|242|B|||
5115|243|N|NOTES:  Do not share this medication with others.||
5115|244|N|   Regular complete physical exams which include lab and/or||
5115|245|N|medical tests (such as potassium blood level, blood pressure,||
5115|246|N|breast exam, pelvic exam, Pap smear) should be done while you are||
5115|247|N|taking this medication. Follow your doctor's instructions for||
5115|248|N|examining your breasts, and report any lumps right away. Keep all||
5115|249|N|medical and lab appointments. Consult your doctor for more||
5115|250|N|details.||
5115|251|B|||
5115|252|D|MISSED DOSE:  Refer to the product package information for advice||
5115|253|D|on missed doses. You may need to use backup birth control (such||
5115|254|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
5115|255|D|pharmacist if you have any questions.||
5115|256|D|   If you often forget to take your pills as directed, contact||
5115|257|D|your doctor to discuss switching to another form of birth||
5115|258|D|control.||
5115|259|B|||
5115|260|R|STORAGE:  Store at room temperature away from light and moisture.||
5115|261|R|Do not store in the bathroom. Keep all medications away from||
5115|262|R|children and pets.||
5115|263|R|   Do not flush medications down the toilet or pour them into a||
5115|264|R|drain unless instructed to do so. Properly discard this product||
5115|265|R|when it is expired or no longer needed. Consult your pharmacist||
5115|266|R|or local waste disposal company.||
5115|267|B|||
5115|268|A|Information last revised October 2025.||
5115|269|A|Copyright(c) 2025 First Databank, Inc.||
5115|270|B|||
5119|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5119|002|Z|does NOT have all possible information about this product. This||
5119|003|Z|information does not assure that this product is safe, effective,||
5119|004|Z|or appropriate for you. This information is not individual||
5119|005|Z|medical advice and does not substitute for the advice of your||
5119|006|Z|health care professional. Always ask your health care||
5119|007|Z|professional for complete information about this product and your||
5119|008|Z|specific health needs.||
5119|009|B|||
5119|010|T|IVERMECTIN - ORAL||
5119|011|F|(EYE-ver-MEK-tin)||
5119|012|B|||
5119|013|C|COMMON BRAND NAME(S): Stromectol||
5119|014|B|||
5119|015|U|USES:  This medication is used to treat certain parasitic||
5119|016|U|roundworm infections. Curing parasitic infections helps to||
5119|017|U|improve your quality of life. In people with weakened defense||
5119|018|U|(immune) systems, curing roundworm infections can reduce the risk||
5119|019|U|of developing a severe or life-threatening infection. Ivermectin||
5119|020|U|belongs to a class of drugs known as antihelmintics. It works by||
5119|021|U|paralyzing and killing parasites.||
5119|022|U|   Ivermectin is not recommended for coronavirus disease, also||
5119|023|U|known as COVID-19, unless you are enrolled in a study. Talk to||
5119|024|U|your doctor about the risks and benefits.||
5119|025|B|||
5119|026|V|OTHER USES:  This section contains uses of this drug that are not||
5119|027|V|listed in the approved professional labeling for the drug but||
5119|028|V|that may be prescribed by your health care professional. Use this||
5119|029|V|drug for a condition that is listed in this section only if it||
5119|030|V|has been so prescribed by your health care professional.||
5119|031|V|   This drug may also be used for other parasitic infections,||
5119|032|V|including lice and scabies.||
5119|033|B|||
5119|034|H|HOW TO USE:  Take this medication by mouth with a full glass of||
5119|035|H|water (8 ounces or 240 milliliters) on an empty stomach (at least||
5119|036|H|1 hour before a meal). Take ivermectin as directed by your||
5119|037|H|doctor, usually as a single dose or a series of doses. The dosage||
5119|038|H|is based on your weight, medical condition, and response to||
5119|039|H|treatment.||
5119|040|H|   Tell your doctor if your condition lasts or gets worse.||
5119|041|B|||
5119|042|S|SIDE EFFECTS:  Headache, dizziness, muscle pain, nausea, or||
5119|043|S|diarrhea may occur. If you are being treated for "river||
5119|044|S|blindness" (onchocerciasis), you may experience reactions to the||
5119|045|S|dying parasites during the first 4 days of treatment, including||
5119|046|S|joint pain, tender/swollen lymph nodes, eye||
5119|047|S|swelling/redness/pain, weakness, vision changes, itching, rash,||
5119|048|S|and fever. If any of these effects last or get worse, tell your||
5119|049|S|doctor or pharmacist promptly.||
5119|050|S|   To reduce dizziness upon standing, get up slowly when rising||
5119|051|S|from a sitting or lying position.||
5119|052|S|   Remember that this medication has been prescribed because your||
5119|053|S|doctor has judged that the benefit to you is greater than the||
5119|054|S|risk of side effects. Many people using this medication do not||
5119|055|S|have serious side effects.||
5119|056|S|   Tell your doctor right away if you have any serious side||
5119|057|S|effects, including: neck/back pain, swelling||
5119|058|S|face/arms/hands/feet, chest pain, fast heartbeat, drowsiness,||
5119|059|S|confusion, seizures.||
5119|060|S|   A very serious allergic reaction to this drug is rare.||
5119|061|S|However, get medical help right away if you notice any symptoms||
5119|062|S|of a serious allergic reaction, including: rash, itching/swelling||
5119|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5119|064|S|breathing.||
5119|065|S|   This is not a complete list of possible side effects. If you||
5119|066|S|notice other effects not listed above, contact your doctor or||
5119|067|S|pharmacist.||
5119|068|S|   In the US -||
5119|069|S|   Call your doctor for medical advice about side effects. You||
5119|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5119|071|S|www.fda.gov/medwatch.||
5119|072|S|   In Canada - Call your doctor for medical advice about side||
5119|073|S|effects. You may report side effects to Health Canada at||
5119|074|S|1-866-234-2345.||
5119|075|B|||
5119|076|P|PRECAUTIONS:  Before taking ivermectin, tell your doctor or||
5119|077|P|pharmacist if you are allergic to it; or if you have any other||
5119|078|P|allergies. This product may contain inactive ingredients, which||
5119|079|P|can cause allergic reactions or other problems. Talk to your||
5119|080|P|pharmacist for more details.||
5119|081|P|   Before using this medication, tell your doctor or pharmacist||
5119|082|P|your medical history, especially of: liver problems.||
5119|083|P|   If you have traveled or lived in West or Central Africa, you||
5119|084|P|may be infected with certain parasites (such as Loa loa, African||
5119|085|P|trypanosomiasis) that could cause problems with ivermectin||
5119|086|P|treatment. These effects could rarely result in serious (possibly||
5119|087|P|fatal) effects on the brain (such as encephalopathy). Consult||
5119|088|P|your doctor for more information.||
5119|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5119|090|P|can make you more dizzy. Do not drive, use machinery, or do||
5119|091|P|anything that needs alertness until you can do it safely. Limit||
5119|092|P|alcoholic beverages. Talk to your doctor if you are using||
5119|093|P|marijuana (cannabis).||
5119|094|P|   Before having surgery, tell your doctor or dentist about all||
5119|095|P|the products you use (including prescription drugs,||
5119|096|P|nonprescription drugs, and herbal products).||
5119|097|P|   If you have a weakened immune system (such as due to HIV||
5119|098|P|infection), you may need repeat treatments with this medicine.||
5119|099|P|Talk to your doctor for more details.||
5119|100|P|   During pregnancy, this medication should be used only when||
5119|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
5119|102|P|   Ivermectin passes into breast milk. Consult your doctor before||
5119|103|P|breastfeeding.||
5119|104|B|||
5119|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5119|106|I|medications work or increase your risk for serious side effects.||
5119|107|I|This document does not contain all possible drug interactions.||
5119|108|I|Keep a list of all the products you use (including||
5119|109|I|prescription/nonprescription drugs and herbal products) and share||
5119|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
5119|111|I|the dosage of any medicines without your doctor's approval.||
5119|112|I|   Some of the products that may interact with this drug include:||
5119|113|I|barbiturates (such as phenobarbital, butalbital), benzodiazepines||
5119|114|I|(such as clonazepam, lorazepam), sodium oxybate (GHB), valproic||
5119|115|I|acid.||
5119|116|B|||
5119|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5119|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5119|119|O|poison control center right away. US residents can call||
5119|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5119|121|O|Symptoms of overdose may include: numbness, tingling, trouble||
5119|122|O|breathing, loss of coordination, seizures.||
5119|123|B|||
5119|124|N|NOTES:  Do not share this medication with others.||
5119|125|N|   Lab and/or medical tests (such as stool exams for intestinal||
5119|126|N|parasites) should be done while you are taking this medication.||
5119|127|N|If you are being treated for "river blindness," you may need more||
5119|128|N|medical examinations and repeated treatment because ivermectin||
5119|129|N|does not kill adult Onchocerca worms. Keep all medical and lab||
5119|130|N|appointments. Consult your doctor for more details.||
5119|131|B|||
5119|132|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5119|133|D|remember. If it is near the time of the next dose, skip the||
5119|134|D|missed dose. Take your next dose at the regular time. Do not||
5119|135|D|double the dose to catch up.||
5119|136|B|||
5119|137|R|STORAGE:  Store at room temperature away from light and moisture.||
5119|138|R|Do not store in the bathroom. Keep all medications away from||
5119|139|R|children and pets.||
5119|140|R|   Do not flush medications down the toilet or pour them into a||
5119|141|R|drain unless instructed to do so. Properly discard this product||
5119|142|R|when it is expired or no longer needed. Consult your pharmacist||
5119|143|R|or local waste disposal company.||
5119|144|B|||
5119|145|A|Information last revised May 2024.||
5119|146|A|Copyright(c) 2025 First Databank, Inc.||
5119|147|B|||
5123|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5123|002|Z|does NOT have all possible information about this product. This||
5123|003|Z|information does not assure that this product is safe, effective,||
5123|004|Z|or appropriate for you. This information is not individual||
5123|005|Z|medical advice and does not substitute for the advice of your||
5123|006|Z|health care professional. Always ask your health care||
5123|007|Z|professional for complete information about this product and your||
5123|008|Z|specific health needs.||
5123|009|B|||
5123|010|T|ALUMINUM/MAGNESIUM ANTACID - ORAL||
5123|011|F|(a-LOO-mi-num/mag-NEE-zee-um an-TAS-id)||
5123|012|B|||
5123|013|C|COMMON BRAND NAME(S): Gaviscon, Gelusil, Maalox, Mylanta, Wingel||
5123|014|B|||
5123|015|U|USES:  This medication is used to treat the symptoms of too much||
5123|016|U|stomach acid such as stomach upset, heartburn, and acid||
5123|017|U|indigestion. Aluminum and magnesium antacids work quickly to||
5123|018|U|lower the acid in the stomach. Liquid antacids usually work||
5123|019|U|faster/better than tablets or capsules.||
5123|020|U|   This medication works only on existing acid in the stomach. It||
5123|021|U|does not prevent acid production. It may be used alone or with||
5123|022|U|other medications that lower acid production (including H2||
5123|023|U|blockers such as cimetidine/ranitidine and proton pump inhibitors||
5123|024|U|such as omeprazole).||
5123|025|B|||
5123|026|H|HOW TO USE:  Take this medication by mouth, usually after meals||
5123|027|H|and at bedtime as needed. Follow all the directions on the||
5123|028|H|product package or use as directed by your doctor. If you have||
5123|029|H|any questions, ask your doctor or pharmacist.||
5123|030|H|   If you are taking the chewable tablets, chew thoroughly before||
5123|031|H|swallowing, then drink a full glass of water (8 ounces or 240||
5123|032|H|milliliters).||
5123|033|H|   If you are using the liquid form of this medication, shake the||
5123|034|H|bottle well before pouring each dose. Refrigerating the||
5123|035|H|suspension may improve the flavor. Do not freeze. The liquid form||
5123|036|H|works best if taken without other fluids. You can mix your dose||
5123|037|H|with a little water if needed.||
5123|038|H|   If your acid problems last or get worse after you have used||
5123|039|H|this product for 1 week, or if you think you have a serious||
5123|040|H|medical problem, get medical help right away. If you are using||
5123|041|H|this medication regularly on a daily basis for more than 2 weeks,||
5123|042|H|you may have a medical problem that needs different treatment.||
5123|043|H|Ask your doctor whether this is the right medication for you.||
5123|044|B|||
5123|045|S|SIDE EFFECTS:  Nausea, constipation, diarrhea, or headache may||
5123|046|S|occur. If any of these effects last or get worse, tell your||
5123|047|S|doctor or pharmacist promptly.||
5123|048|S|   The magnesium in this product can cause diarrhea. Using an||
5123|049|S|antacid that contains only aluminum along with this product can||
5123|050|S|help control diarrhea. The aluminum in this product can cause||
5123|051|S|constipation. To minimize constipation, drink plenty of fluids||
5123|052|S|and exercise. Diarrhea is more common with this product than||
5123|053|S|constipation.||
5123|054|S|   If your doctor has directed you to use this medication,||
5123|055|S|remember that your doctor has judged that the benefit to you is||
5123|056|S|greater than the risk of side effects. Many people using this||
5123|057|S|medication do not have serious side effects.||
5123|058|S|   Aluminum-containing antacids bind to phosphate, an important||
5123|059|S|body chemical, in the gut. This can cause low phosphate levels,||
5123|060|S|especially if you use this medication in large doses and for a||
5123|061|S|long time. Tell your doctor right away if you have any of the||
5123|062|S|following symptoms of low phosphate: loss of appetite, unusual||
5123|063|S|tiredness, muscle weakness.||
5123|064|S|   Tell your doctor right away if you have any serious side||
5123|065|S|effects, including: dizziness, fainting.||
5123|066|S|   Get medical help right away if you have any very serious side||
5123|067|S|effects, including: slow/shallow breathing, slow/irregular||
5123|068|S|heartbeat, mental/mood changes (such as confusion), deep sleep,||
5123|069|S|pain with urination.||
5123|070|S|   A very serious allergic reaction to this drug is rare.||
5123|071|S|However, get medical help right away if you notice any symptoms||
5123|072|S|of a serious allergic reaction, including: rash, itching/swelling||
5123|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5123|074|S|breathing.||
5123|075|S|   This is not a complete list of possible side effects. If you||
5123|076|S|notice other effects not listed above, contact your doctor or||
5123|077|S|pharmacist.||
5123|078|S|   In the US -||
5123|079|S|   Call your doctor for medical advice about side effects. You||
5123|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5123|081|S|www.fda.gov/medwatch.||
5123|082|S|   In Canada - Call your doctor for medical advice about side||
5123|083|S|effects. You may report side effects to Health Canada at||
5123|084|S|1-866-234-2345.||
5123|085|B|||
5123|086|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
5123|087|P|pharmacist if you are allergic to aluminum hydroxide; or to||
5123|088|P|magnesium; or if you have any other allergies. This product may||
5123|089|P|contain inactive ingredients, which can cause allergic reactions||
5123|090|P|or other problems. Talk to your pharmacist for more details.||
5123|091|P|   If you have any of the following health problems, consult your||
5123|092|P|doctor or pharmacist before using this product: frequent alcohol||
5123|093|P|use, dehydration/fluid restriction, kidney problems (including||
5123|094|P|kidney stones).||
5123|095|P|   This medicine may contain aspartame. If you have||
5123|096|P|phenylketonuria (PKU) or any other condition that requires you to||
5123|097|P|restrict your intake of aspartame (or phenylalanine), consult||
5123|098|P|your doctor or pharmacist about using this drug safely.||
5123|099|P|   Before having surgery, tell your doctor or dentist about all||
5123|100|P|the products you use (including prescription drugs,||
5123|101|P|nonprescription drugs, and herbal products).||
5123|102|P|   During pregnancy, this medication should be used only when||
5123|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
5123|104|P|   This medication may pass into breast milk. Consult your doctor||
5123|105|P|before breastfeeding.||
5123|106|B|||
5123|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5123|108|I|medications work or increase your risk for serious side effects.||
5123|109|I|This document does not contain all possible drug interactions.||
5123|110|I|Keep a list of all the products you use (including||
5123|111|I|prescription/nonprescription drugs and herbal products) and share||
5123|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
5123|113|I|the dosage of any medicines without your doctor's approval.||
5123|114|I|   Antacids can interfere with the absorption of many other||
5123|115|I|drugs. Be sure to check with your pharmacist before taking||
5123|116|I|antacids with any other medication.||
5123|117|B|||
5123|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5123|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5123|120|O|poison control center right away. US residents can call||
5123|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5123|122|B|||
5123|123|N|NOTES:  Keep all medical and lab appointments.||
5123|124|N|   Lifestyle changes such as stress reduction programs, stopping||
5123|125|N|smoking, limiting alcohol, and diet changes (such as avoiding||
5123|126|N|caffeine, fatty foods, certain spices) may increase the||
5123|127|N|effectiveness of this medication. Talk to your doctor or||
5123|128|N|pharmacist about lifestyle changes that might benefit you.||
5123|129|B|||
5123|130|D|MISSED DOSE:  If you are taking this product on a regular||
5123|131|D|schedule and miss a dose, take it as soon as you remember. If it||
5123|132|D|is near the time of the next dose, skip the missed dose. Take||
5123|133|D|your next dose at the regular time. Do not double the dose to||
5123|134|D|catch up.||
5123|135|B|||
5123|136|R|STORAGE:  Store at room temperature away from light and moisture.||
5123|137|R|Do not freeze. Do not store in the bathroom. Keep all medications||
5123|138|R|away from children and pets.||
5123|139|R|   Do not flush medications down the toilet or pour them into a||
5123|140|R|drain unless instructed to do so. Properly discard this product||
5123|141|R|when it is expired or no longer needed. Consult your pharmacist||
5123|142|R|or local waste disposal company.||
5123|143|B|||
5123|144|A|Information last revised October 2025.||
5123|145|A|Copyright(c) 2025 First Databank, Inc.||
5123|146|B|||
5126|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5126|002|Z|does NOT have all possible information about this product. This||
5126|003|Z|information does not assure that this product is safe, effective,||
5126|004|Z|or appropriate for you. This information is not individual||
5126|005|Z|medical advice and does not substitute for the advice of your||
5126|006|Z|health care professional. Always ask your health care||
5126|007|Z|professional for complete information about this product and your||
5126|008|Z|specific health needs.||
5126|009|B|||
5126|010|T|IRON/VITAMIN C/VITAMIN B12/FOLIC ACID - ORAL||
5126|011|F|(EYE-urn/vitamin C/vitamin B12/FOH-lik)||
5126|012|B|||
5126|013|W|WARNING:  Accidental overdose of iron-containing products is a||
5126|014|W|leading cause of fatal poisoning in children under 6 years. Keep||
5126|015|W|this product out of reach of children. If overdose does occur,||
5126|016|W|get medical help right away or call a poison control center.||
5126|017|B|||
5126|018|U|USES:  This combination product contains a mineral (iron) along||
5126|019|U|with 3 vitamins (vitamin C, vitamin B12, and folic acid). It is||
5126|020|U|used to treat or prevent a lack of these nutrients which may||
5126|021|U|occur in certain health conditions (such as anemia, pregnancy,||
5126|022|U|poor diet, surgery recovery). Iron is an important mineral that||
5126|023|U|the body needs to produce red blood cells. Vitamin C improves the||
5126|024|U|absorption of iron from the stomach. Vitamin B12 is important for||
5126|025|U|normal blood, cells, and nerves. Folic acid is needed to form||
5126|026|U|healthy cells, especially red blood cells.||
5126|027|U|   Women of childbearing age should maintain adequate amounts of||
5126|028|U|folic acid either through diet or supplements to prevent spinal||
5126|029|U|cord birth defects.||
5126|030|B|||
5126|031|H|HOW TO USE:  If you are taking the over-the-counter product, read||
5126|032|H|all directions on the product package before taking this||
5126|033|H|medication. Take this medication by mouth, usually once daily or||
5126|034|H|as directed by your doctor.||
5126|035|H|   This medication is best taken on an empty stomach 1 hour||
5126|036|H|before or 2 hours after meals. If stomach upset occurs, you may||
5126|037|H|take this medication with food. Avoid taking antacids, dairy||
5126|038|H|products, tea, or coffee within 2 hours before or after this||
5126|039|H|medication because they will decrease its effectiveness.||
5126|040|H|   Take with a full glass of water (8 ounces or 240 milliliters)||
5126|041|H|unless your doctor directs you otherwise. Do not lie down for at||
5126|042|H|least 10 minutes after taking this medication.||
5126|043|H|   If you are using the liquid form of this medication, carefully||
5126|044|H|measure the dose using a special measuring device/spoon. Do not||
5126|045|H|use a household spoon because you may not get the correct dose.||
5126|046|H|To prevent staining the teeth, you may mix the dose in a glass of||
5126|047|H|water or juice, and drink it through a straw. If your liquid form||
5126|048|H|is to be given by dropper, the dose may be placed well back on||
5126|049|H|the tongue and followed with water or juice. If your liquid form||
5126|050|H|is a suspension, shake the bottle well before each dose.||
5126|051|H|   If you are taking extended-release capsules, swallow the||
5126|052|H|capsules whole. Do not crush or chew the capsules. Doing so can||
5126|053|H|release all of the drug at once, increasing the risk of side||
5126|054|H|effects.||
5126|055|H|   Use this medication regularly in order to get the most benefit||
5126|056|H|from it. To help you remember, take it at the same time each day.||
5126|057|B|||
5126|058|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
5126|059|S|occur. These effects are usually temporary and may disappear as||
5126|060|S|your body adjusts to this medication. If any of these effects||
5126|061|S|last or get worse, tell your doctor or pharmacist promptly.||
5126|062|S|   Iron may cause your stools to turn black, which is not||
5126|063|S|harmful.||
5126|064|S|   If your doctor has prescribed this medication, remember that||
5126|065|S|your doctor has judged that the benefit to you is greater than||
5126|066|S|the risk of side effects. Many people using this medication do||
5126|067|S|not have serious side effects.||
5126|068|S|   A very serious allergic reaction to this drug is rare.||
5126|069|S|However, get medical help right away if you notice any symptoms||
5126|070|S|of a serious allergic reaction, including: rash, itching/swelling||
5126|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5126|072|S|breathing.||
5126|073|S|   This is not a complete list of possible side effects. If you||
5126|074|S|notice other effects not listed above, contact your doctor or||
5126|075|S|pharmacist.||
5126|076|S|   In the US -||
5126|077|S|   Call your doctor for medical advice about side effects. You||
5126|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5126|079|S|www.fda.gov/medwatch.||
5126|080|S|   In Canada - Call your doctor for medical advice about side||
5126|081|S|effects. You may report side effects to Health Canada at||
5126|082|S|1-866-234-2345.||
5126|083|B|||
5126|084|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
5126|085|P|pharmacist if you are allergic to any of its ingredients; or if||
5126|086|P|you have any other allergies. This product may contain inactive||
5126|087|P|ingredients, which can cause allergic reactions or other||
5126|088|P|problems. Talk to your pharmacist for more details.||
5126|089|P|   Before taking this medication, tell your doctor or pharmacist||
5126|090|P|your medical history, especially of: certain metabolic disorders||
5126|091|P|(such as hemochromatosis, hemosiderosis), use/abuse of alcohol,||
5126|092|P|stomach/intestinal problems (such as ulcers, colitis), vitamin||
5126|093|P|B12 deficiency (pernicious anemia).||
5126|094|P|   Before having surgery, tell your doctor or dentist about all||
5126|095|P|the products you use (including prescription drugs,||
5126|096|P|nonprescription drugs, and herbal products).||
5126|097|P|   During pregnancy, this medication should be used only when||
5126|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
5126|099|P|   This medication passes into breast milk. Consult your doctor||
5126|100|P|before breastfeeding.||
5126|101|B|||
5126|102|I|DRUG INTERACTIONS:  See also How To Use section.||
5126|103|I|   Drug interactions may change how your medications work or||
5126|104|I|increase your risk for serious side effects. This document does||
5126|105|I|not contain all possible drug interactions. Keep a list of all||
5126|106|I|the products you use (including prescription/nonprescription||
5126|107|I|drugs and herbal products) and share it with your doctor and||
5126|108|I|pharmacist. Do not start, stop, or change the dosage of any||
5126|109|I|medicines without your doctor's approval.||
5126|110|I|   This product can decrease the absorption of certain drugs,||
5126|111|I|especially if you take them around the same time. These drugs||
5126|112|I|include bisphosphonates (such as alendronate), levodopa,||
5126|113|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
5126|114|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
5126|115|I|minocycline), thyroid medications (such as levothyroxine), among||
5126|116|I|others. Ask your doctor or pharmacist how long you should wait||
5126|117|I|between doses of this product and your other medications and to||
5126|118|I|find a dosing schedule that works for all your medications.||
5126|119|I|   This medication may interfere with certain lab tests (such as||
5126|120|I|tests for blood in the stools), possibly causing false test||
5126|121|I|results. Make sure lab personnel and all your doctors know you||
5126|122|I|use this drug.||
5126|123|B|||
5126|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5126|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5126|126|O|poison control center right away. US residents can call||
5126|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5126|128|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
5126|129|O|diarrhea.||
5126|130|B|||
5126|131|N|NOTES:  If your doctor has prescribed this medication for you, do||
5126|132|N|not share it with others.||
5126|133|N|   Lab and/or medical tests (such as complete blood count,||
5126|134|N|vitamin B12 levels) may be done while you are taking this||
5126|135|N|product. Keep all medical and lab appointments. Consult your||
5126|136|N|doctor for more details.||
5126|137|N|   There are many iron supplement products available, both with||
5126|138|N|and without a prescription. Some brands also contain ingredients||
5126|139|N|(such as succinic acid, docusate) that might help your body||
5126|140|N|absorb more iron or decrease side effects. Consult your doctor or||
5126|141|N|pharmacist if you have questions about available iron supplements||
5126|142|N|or their ingredients.||
5126|143|N|   This medication is not a substitute for a proper diet. It is||
5126|144|N|important to maintain a well-balanced diet. Foods rich in iron||
5126|145|N|include beans, nuts, asparagus, oatmeal, red meat, dried peaches,||
5126|146|N|and pork liver. B vitamins (including folic acid) are naturally||
5126|147|N|found in leafy greens and other vegetables, meat, fish, poultry,||
5126|148|N|and enriched breads/cereals.||
5126|149|B|||
5126|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5126|151|D|remember. If it is near the time of the next dose, skip the||
5126|152|D|missed dose. Take your next dose at the regular time. Do not||
5126|153|D|double the dose to catch up.||
5126|154|B|||
5126|155|R|STORAGE:  Different brands of this medication have different||
5126|156|R|storage needs. Check the product package for instructions on how||
5126|157|R|to store your brand, or ask your pharmacist. Keep all medications||
5126|158|R|away from children and pets.||
5126|159|R|   Do not flush medications down the toilet or pour them into a||
5126|160|R|drain unless instructed to do so. Properly discard this product||
5126|161|R|when it is expired or no longer needed. Consult your pharmacist||
5126|162|R|or local waste disposal company.||
5126|163|B|||
5126|164|A|Information last revised October 2025.||
5126|165|A|Copyright(c) 2025 First Databank, Inc.||
5126|166|B|||
5128|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5128|002|Z|does NOT have all possible information about this product. This||
5128|003|Z|information does not assure that this product is safe, effective,||
5128|004|Z|or appropriate for you. This information is not individual||
5128|005|Z|medical advice and does not substitute for the advice of your||
5128|006|Z|health care professional. Always ask your health care||
5128|007|Z|professional for complete information about this product and your||
5128|008|Z|specific health needs.||
5128|009|B|||
5128|010|T|PRIMAQUINE - ORAL||
5128|011|F|(PRIM-uh-kwin)||
5128|012|B|||
5128|013|C|COMMON BRAND NAME(S): Primaquine||
5128|014|B|||
5128|015|U|USES:  Primaquine is used with other medications to prevent and||
5128|016|U|treat malaria caused by mosquito bites in countries where malaria||
5128|017|U|is common. Malaria parasites can enter the body through these||
5128|018|U|mosquito bites, and then live in body tissues such as red blood||
5128|019|U|cells or the liver. Primaquine is used after other medications||
5128|020|U|(such as chloroquine) have killed the malaria parasites living||
5128|021|U|inside red blood cells. Primaquine then kills the malaria||
5128|022|U|parasites living in other body tissues. This prevents the return||
5128|023|U|of the infection. Both drugs are needed for a complete cure.||
5128|024|U|Primaquine belongs to a class of drugs known as antimalarials.||
5128|025|U|   The United States Centers for Disease Control provide updated||
5128|026|U|guidelines and travel recommendations for the prevention and||
5128|027|U|treatment of malaria in different parts of the world. Discuss the||
5128|028|U|most recent information with your doctor before traveling to||
5128|029|U|areas where malaria occurs.||
5128|030|B|||
5128|031|V|OTHER USES:  This section contains uses of this drug that are not||
5128|032|V|listed in the approved professional labeling for the drug but||
5128|033|V|that may be prescribed by your health care professional. Use this||
5128|034|V|drug for a condition that is listed in this section only if it||
5128|035|V|has been so prescribed by your health care professional.||
5128|036|V|   This drug may also be used for pneumocystis pneumonia (PCP) in||
5128|037|V|people with AIDS.||
5128|038|B|||
5128|039|H|HOW TO USE:  Take this medication by mouth as directed by your||
5128|040|H|doctor, usually once daily. Take with food to prevent stomach||
5128|041|H|upset. Follow your doctor's directions exactly. Primaquine is||
5128|042|H|usually taken for 2 weeks after you have left the malarious area.||
5128|043|H|It is started during the last 1 to 2 weeks of your other malaria||
5128|044|H|treatment or immediately after you have finished your other||
5128|045|H|treatment. Primaquine should not be taken for more than 14 days||
5128|046|H|for malaria treatment.||
5128|047|H|   The dosage is based on the kind of infection you have and your||
5128|048|H|response to treatment. Take this medication regularly. To help||
5128|049|H|you remember, take it at the same time every day.||
5128|050|H|   It is very important to keep taking this medication exactly as||
5128|051|H|prescribed by your doctor. Do not take more or less of this drug||
5128|052|H|than prescribed. Do not stop taking it before completing||
5128|053|H|treatment, even if you feel better, unless directed to do so by||
5128|054|H|your doctor. Skipping or changing your dose without approval from||
5128|055|H|your doctor may cause prevention/treatment to be ineffective,||
5128|056|H|cause the amount of parasite to increase, make the infection more||
5128|057|H|difficult to treat (resistant), or worsen side effects.||
5128|058|H|   It is important to prevent mosquito bites (such as by using||
5128|059|H|appropriate insect repellents, wearing clothes that cover most of||
5128|060|H|the body, remaining in air-conditioned or well-screened areas,||
5128|061|H|using mosquito nets, using insect-killing spray). Buy insect||
5128|062|H|repellent before traveling. The most effective insect repellents||
5128|063|H|contain diethyltoluamide (DEET). Ask your doctor or pharmacist to||
5128|064|H|recommend the appropriate strengths of mosquito repellent for||
5128|065|H|you/your children.||
5128|066|H|   No drug treatment is completely effective in preventing||
5128|067|H|malaria. Get medical help right away if you develop symptoms of||
5128|068|H|malaria (such as fever, chills, headache, other flu-like||
5128|069|H|symptoms), especially while in the malarious area and even after||
5128|070|H|completing this prescription. Quick treatment of malaria||
5128|071|H|infection is needed to prevent serious, possibly fatal, outcomes.||
5128|072|H|   When using primaquine phosphate for treatment of infection,||
5128|073|H|tell your doctor if your condition lasts or gets worse.||
5128|074|B|||
5128|075|S|SIDE EFFECTS:  Nausea, vomiting, dizziness, stomach upset, and||
5128|076|S|abdominal cramps may occur. If any of these effects last or get||
5128|077|S|worse, tell your doctor or pharmacist promptly.||
5128|078|S|   Remember that this medication has been prescribed because your||
5128|079|S|doctor has judged that the benefit to you is greater than the||
5128|080|S|risk of side effects. Many people using this medication do not||
5128|081|S|have serious side effects.||
5128|082|S|   Tell your doctor right away if you have any serious side||
5128|083|S|effects, including: signs of infection (such as sore throat that||
5128|084|S|doesn't go away, fever, chills), signs of a sudden loss of red||
5128|085|S|blood cells (such as unusual tiredness, brown urine, pale||
5128|086|S|lips/nails/skin, fast heartbeat, rapid breathing), signs of a||
5128|087|S|certain blood problem (methemoglobinemia, including bluish||
5128|088|S|skin/lips/nails, headache, shortness of breath, lightheadedness,||
5128|089|S|weakness, confusion, chest pain, sudden pounding heartbeat).||
5128|090|S|   Get medical help right away if you have any very serious side||
5128|091|S|effects, including: fast/irregular heartbeat, severe dizziness,||
5128|092|S|fainting.||
5128|093|S|   A very serious allergic reaction to this drug is rare.||
5128|094|S|However, get medical help right away if you notice any symptoms||
5128|095|S|of a serious allergic reaction, including: rash, itching/swelling||
5128|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5128|097|S|breathing.||
5128|098|S|   This is not a complete list of possible side effects. If you||
5128|099|S|notice other effects not listed above, contact your doctor or||
5128|100|S|pharmacist.||
5128|101|S|   In the US -||
5128|102|S|   Call your doctor for medical advice about side effects. You||
5128|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5128|104|S|www.fda.gov/medwatch.||
5128|105|S|   In Canada - Call your doctor for medical advice about side||
5128|106|S|effects. You may report side effects to Health Canada at||
5128|107|S|1-866-234-2345.||
5128|108|B|||
5128|109|P|PRECAUTIONS:  Before taking primaquine, tell your doctor or||
5128|110|P|pharmacist if you are allergic to it; or to tafenoquine; or if||
5128|111|P|you have any other allergies. This product may contain inactive||
5128|112|P|ingredients, which can cause allergic reactions or other||
5128|113|P|problems. Talk to your pharmacist for more details.||
5128|114|P|   Before using this medication, tell your doctor or pharmacist||
5128|115|P|your medical history, especially of: immune system disease (such||
5128|116|P|as lupus, rheumatoid arthritis), blood problems (such as low||
5128|117|P|white blood cell counts, anemia), history of blood problems due||
5128|118|P|to primaquine (such as hemolytic anemia, methemoglobinemia),||
5128|119|P|personal/family history of favism, low levels of certain blood||
5128|120|P|enzymes (glucose-6-phosphate dehydrogenase-G6PD, NADH||
5128|121|P|methemoglobin reductase).||
5128|122|P|   Your doctor may order a blood test to see if you have any||
5128|123|P|enzyme deficiency before starting primaquine.||
5128|124|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5128|125|P|can make you more dizzy. Do not drive, use machinery, or do||
5128|126|P|anything that needs alertness until you can do it safely. Limit||
5128|127|P|alcoholic beverages. Talk to your doctor if you are using||
5128|128|P|marijuana (cannabis).||
5128|129|P|   Primaquine may cause a condition that affects the heart rhythm||
5128|130|P|(QT prolongation). QT prolongation can rarely cause serious||
5128|131|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
5128|132|P|as severe dizziness, fainting) that need medical attention right||
5128|133|P|away.||
5128|134|P|   The risk of QT prolongation may be increased if you have||
5128|135|P|certain medical conditions or are taking other drugs that may||
5128|136|P|cause QT prolongation. Before using primaquine, tell your doctor||
5128|137|P|or pharmacist of all the drugs you take and if you have any of||
5128|138|P|the following conditions: certain heart problems (heart failure,||
5128|139|P|slow heartbeat, QT prolongation in the EKG), family history of||
5128|140|P|certain heart problems (QT prolongation in the EKG, sudden||
5128|141|P|cardiac death).||
5128|142|P|   Low levels of potassium or magnesium in the blood may also||
5128|143|P|increase your risk of QT prolongation. This risk may increase if||
5128|144|P|you use certain drugs (such as diuretics/"water pills") or if you||
5128|145|P|have conditions such as severe sweating, diarrhea, or vomiting.||
5128|146|P|Talk to your doctor about using primaquine safely.||
5128|147|P|   Before having surgery, tell your doctor or dentist about all||
5128|148|P|the products you use (including prescription drugs,||
5128|149|P|nonprescription drugs, and herbal products).||
5128|150|P|   Older adults may be more sensitive to the side effects of this||
5128|151|P|drug, especially QT prolongation (see above).||
5128|152|P|   This medication must not be used during pregnancy. It may harm||
5128|153|P|an unborn baby. Women of childbearing age should have a pregnancy||
5128|154|P|test before starting this medication. It is important to prevent||
5128|155|P|pregnancy during and after treatment with primaquine. Men and||
5128|156|P|women must use reliable forms of birth control (such as condoms,||
5128|157|P|birth control pills) during treatment. Men should continue to use||
5128|158|P|birth control for at least 3 months after the end of treatment.||
5128|159|P|Women should continue to use birth control for at least 1||
5128|160|P|menstrual cycle after the end of treatment. If you become||
5128|161|P|pregnant or think you may be pregnant, tell your doctor right||
5128|162|P|away. While you are pregnant, traveling to an area with malaria||
5128|163|P|puts you and your infant at a much higher risk for death and||
5128|164|P|other problems. The CDC recommends continuing your other malaria||
5128|165|P|treatment (such as chloroquine) throughout pregnancy until||
5128|166|P|delivery to prevent harm to your unborn baby (hemolytic anemia).||
5128|167|P|After delivery, you may finish treatment with primaquine. Discuss||
5128|168|P|the risks and benefits with your doctor.||
5128|169|P|   This medication passes into breast milk and may increase the||
5128|170|P|risk of hemolytic anemia in a nursing infant with G6PD||
5128|171|P|deficiency. The doctor should test your infant for G6PD||
5128|172|P|deficiency before you start breastfeeding. Because of the||
5128|173|P|possible risk to the infant, breastfeeding is not recommended||
5128|174|P|while using this medication if your baby has G6PD deficiency or||
5128|175|P|if your baby has not been tested. Consult your doctor before||
5128|176|P|breastfeeding.||
5128|177|B|||
5128|178|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5128|179|I|medications work or increase your risk for serious side effects.||
5128|180|I|This document does not contain all possible drug interactions.||
5128|181|I|Keep a list of all the products you use (including||
5128|182|I|prescription/nonprescription drugs and herbal products) and share||
5128|183|I|it with your doctor and pharmacist. Do not start, stop, or change||
5128|184|I|the dosage of any medicines without your doctor's approval.||
5128|185|I|   Some products that may interact with this drug include:||
5128|186|I|penicillamine, quinacrine, drugs that may cause decreased blood||
5128|187|I|cells (such as trimethoprim, zidovudine, pyrimethamine,||
5128|188|I|azathioprine).||
5128|189|B|||
5128|190|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5128|191|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5128|192|O|poison control center right away. US residents can call||
5128|193|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5128|194|O|Symptoms of overdose may include: extreme drowsiness, seizures,||
5128|195|O|fast/irregular heartbeat.||
5128|196|B|||
5128|197|N|NOTES:  Do not share this medication with others.||
5128|198|N|   Lab and/or medical tests (such as G6PD blood test, blood cell||
5128|199|N|counts) should be done before you start taking this medication||
5128|200|N|and while you are taking it. Keep all medical and lab||
5128|201|N|appointments. Consult your doctor for more details.||
5128|202|B|||
5128|203|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5128|204|D|remember. If it is near the time of the next dose, skip the||
5128|205|D|missed dose. Take your next dose at the regular time. Do not||
5128|206|D|double the dose to catch up.||
5128|207|B|||
5128|208|R|STORAGE:  Store at room temperature away from light and moisture.||
5128|209|R|Do not store in the bathroom. Keep all medications away from||
5128|210|R|children and pets.||
5128|211|R|   Do not flush medications down the toilet or pour them into a||
5128|212|R|drain unless instructed to do so. Properly discard this product||
5128|213|R|when it is expired or no longer needed. Consult your pharmacist||
5128|214|R|or local waste disposal company.||
5128|215|B|||
5128|216|A|Information last revised April 2025.||
5128|217|A|Copyright(c) 2025 First Databank, Inc.||
5128|218|B|||
5130|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5130|002|Z|does NOT have all possible information about this product. This||
5130|003|Z|information does not assure that this product is safe, effective,||
5130|004|Z|or appropriate for you. This information is not individual||
5130|005|Z|medical advice and does not substitute for the advice of your||
5130|006|Z|health care professional. Always ask your health care||
5130|007|Z|professional for complete information about this product and your||
5130|008|Z|specific health needs.||
5130|009|B|||
5130|010|T|SULFACETAMIDE/SULFUR CREAM - TOPICAL||
5130|011|F|(sull-fuh-SEET-uh-mide/SULL-fur)||
5130|012|B|||
5130|013|C|COMMON BRAND NAME(S): Avar, Plexion SCT||
5130|014|B|||
5130|015|U|USES:  This medication is used to treat acne and other skin||
5130|016|U|conditions (such as rosacea, seborrheic dermatitis). It helps to||
5130|017|U|relieve the symptoms of skin irritation caused by these||
5130|018|U|conditions. This product contains a combination of two drugs,||
5130|019|U|sulfacetamide and sulfur. Both sulfacetamide and sulfur stop the||
5130|020|U|growth of bacteria on the skin surface. Sulfur also has a drying||
5130|021|U|effect on the skin that helps the skin to shed old cells.||
5130|022|B|||
5130|023|H|HOW TO USE:  This medication is for use on the skin only.||
5130|024|H|   The directions for use of this product vary depending on the||
5130|025|H|brand that you are prescribed. Follow the directions provided by||
5130|026|H|your doctor or pharmacist.||
5130|027|H|   Avoid getting any of this medication in the eyes or inside the||
5130|028|H|nose or mouth.||
5130|029|H|   Tell your doctor if your condition does not get better or if||
5130|030|H|it gets worse.||
5130|031|B|||
5130|032|S|SIDE EFFECTS:  Mild redness and dry skin may occur. If either of||
5130|033|S|these effects lasts or gets worse, tell your doctor or pharmacist||
5130|034|S|promptly.||
5130|035|S|   Remember that this medication has been prescribed because your||
5130|036|S|doctor has judged that the benefit to you is greater than the||
5130|037|S|risk of side effects. Many people using this medication do not||
5130|038|S|have serious side effects.||
5130|039|S|   Stop using this medication and tell your doctor right away if||
5130|040|S|you have any serious side effects, including: skin irritation,||
5130|041|S|scaling of the skin, signs of infection (such as sore throat that||
5130|042|S|doesn't go away, fever, chills), unusual weakness, easy||
5130|043|S|bleeding/bruising, yellowing eyes/skin.||
5130|044|S|   You may be at increased risk for side effects if this||
5130|045|S|medication is used on raw or broken skin. Consult your doctor for||
5130|046|S|details.||
5130|047|S|   A very serious allergic reaction to this drug is rare.||
5130|048|S|However, get medical help right away if you notice any symptoms||
5130|049|S|of a serious allergic reaction, including: rash, itching/swelling||
5130|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5130|051|S|breathing.||
5130|052|S|   This is not a complete list of possible side effects. If you||
5130|053|S|notice other effects not listed above, contact your doctor or||
5130|054|S|pharmacist.||
5130|055|S|   In the US -||
5130|056|S|   Call your doctor for medical advice about side effects. You||
5130|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5130|058|S|www.fda.gov/medwatch.||
5130|059|S|   In Canada - Call your doctor for medical advice about side||
5130|060|S|effects. You may report side effects to Health Canada at||
5130|061|S|1-866-234-2345.||
5130|062|B|||
5130|063|P|PRECAUTIONS:  Before using sulfacetamide with sulfur, tell your||
5130|064|P|doctor or pharmacist if you are allergic to either of these||
5130|065|P|drugs; or to sulfa medications; or if you have any other||
5130|066|P|allergies. This product may contain inactive ingredients, which||
5130|067|P|can cause allergic reactions or other problems. Talk to your||
5130|068|P|pharmacist for more details.||
5130|069|P|   Before using this medication, tell your doctor or pharmacist||
5130|070|P|your medical history, especially of: kidney problems, cracked||
5130|071|P|skin or open wounds (especially on the face or hands).||
5130|072|P|   During pregnancy, this medication should be used only when||
5130|073|P|clearly needed. Discuss the risks and benefits with your doctor.||
5130|074|P|   It is unknown if the drugs in this product pass into breast||
5130|075|P|milk when applied to the skin. Consult your doctor before||
5130|076|P|breastfeeding.||
5130|077|B|||
5130|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5130|079|I|medications work or increase your risk for serious side effects.||
5130|080|I|This document does not contain all possible drug interactions.||
5130|081|I|Keep a list of all the products you use (including||
5130|082|I|prescription/nonprescription drugs and herbal products) and share||
5130|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
5130|084|I|the dosage of any medicines without your doctor's approval.||
5130|085|I|   Some products that may interact with this drug are: skin||
5130|086|I|products containing silver (such as silver sulfadiazine).||
5130|087|B|||
5130|088|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5130|089|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5130|090|O|poison control center right away. US residents can call||
5130|091|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
5130|092|O|medicine may be harmful if swallowed.||
5130|093|B|||
5130|094|N|NOTES:  Do not share this medication with others.||
5130|095|B|||
5130|096|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5130|097|D|If it is near the time of the next dose, skip the missed dose.||
5130|098|D|Use your next dose at the regular time. Do not double the dose to||
5130|099|D|catch up.||
5130|100|B|||
5130|101|R|STORAGE:  Store at room temperature. Keep all medications away||
5130|102|R|from children and pets.||
5130|103|R|   Do not flush medications down the toilet or pour them into a||
5130|104|R|drain unless instructed to do so. Properly discard this product||
5130|105|R|when it is expired or no longer needed. Consult your pharmacist||
5130|106|R|or local waste disposal company.||
5130|107|B|||
5130|108|A|Information last revised April 2025.||
5130|109|A|Copyright(c) 2025 First Databank, Inc.||
5130|110|B|||
5133|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5133|002|Z|does NOT have all possible information about this product. This||
5133|003|Z|information does not assure that this product is safe, effective,||
5133|004|Z|or appropriate for you. This information is not individual||
5133|005|Z|medical advice and does not substitute for the advice of your||
5133|006|Z|health care professional. Always ask your health care||
5133|007|Z|professional for complete information about this product and your||
5133|008|Z|specific health needs.||
5133|009|B|||
5133|010|T|INTERFERON ALFA - INJECTION||
5133|011|F|(in-ter-FEER-on AL-fuh)||
5133|012|B|||
5133|013|C|COMMON BRAND NAME(S): Alferon N, Intron A, Roferon-A||
5133|014|B|||
5133|015|W|WARNING:  This medication can rarely cause or worsen serious||
5133|016|W|(rarely fatal) medical conditions, including mental/mood||
5133|017|W|conditions (such as depression), immune system problems||
5133|018|W|(autoimmune conditions such as lupus or rheumatoid arthritis),||
5133|019|W|circulation problems, or infections. If your medical history||
5133|020|W|includes any of these conditions, tell your doctor promptly.||
5133|021|W|Also, tell your doctor right away if any serious symptoms or side||
5133|022|W|effects occur (see Side Effects section).||
5133|023|W|   This medication may be combined with ribavirin to treat||
5133|024|W|chronic hepatitis C. Ribavirin may cause harm to an unborn baby||
5133|025|W|or death. Women must avoid pregnancy while they or their male||
5133|026|W|partners are using ribavirin. Ribavirin may cause a blood||
5133|027|W|disorder (hemolytic anemia), which can worsen heart disease. If||
5133|028|W|you are using this medication with ribavirin to treat chronic||
5133|029|W|hepatitis C, also carefully read the drug information for||
5133|030|W|ribavirin.||
5133|031|B|||
5133|032|U|USES:  This medication is used to treat various cancers (such as||
5133|033|U|leukemia, melanoma, AIDS-related Kaposi's sarcoma). It is also||
5133|034|U|used to treat virus infections (such as chronic hepatitis B,||
5133|035|U|chronic hepatitis C, condylomata acuminata). This medication is||
5133|036|U|the same as a protein that your body naturally produces||
5133|037|U|(interferon). In the body, it is thought to work by affecting||
5133|038|U|cell function/growth and the body's natural defenses (immune||
5133|039|U|system) in many ways. Adding more interferon may help your body||
5133|040|U|fight off cancer or virus infections.||
5133|041|B|||
5133|042|H|HOW TO USE:  Read the Medication Guide provided by your||
5133|043|H|pharmacist before you start using this drug and each time you get||
5133|044|H|a refill. If you have any questions, consult your doctor or||
5133|045|H|pharmacist.||
5133|046|H|   This medication is given by injection into a muscle or under||
5133|047|H|the skin as directed by your doctor. It is best used in the||
5133|048|H|evening before bedtime to reduce side effects. Change the||
5133|049|H|injection site each time to lessen injury under the skin. This||
5133|050|H|medication may also be given by injection into a vein or directly||
5133|051|H|into a lesion, usually by a health care professional. The dosage||
5133|052|H|is based on your medical condition and response to treatment.||
5133|053|H|   If you are giving this medication to yourself at home, learn||
5133|054|H|all preparation and usage instructions from your health care||
5133|055|H|professional. Do not shake the medication. Before using, check||
5133|056|H|this product for particles or discoloration. If either is||
5133|057|H|present, do not use the liquid. Learn how to store and discard||
5133|058|H|medical supplies safely.||
5133|059|H|   Drink plenty of fluids while using this medication unless||
5133|060|H|otherwise directed by your doctor.||
5133|061|H|   Use this medication regularly to get the most benefit from it.||
5133|062|H|To help you remember, use it at the same time each evening that||
5133|063|H|you have a scheduled dose.||
5133|064|H|   Different brands of interferon alfa can result in different||
5133|065|H|amounts of medication in the blood. This medication comes in||
5133|066|H|different forms (a powder in a vial, a solution in a vial, and a||
5133|067|H|multidose pen). The way you inject this medication depends on the||
5133|068|H|form you are using. Follow your doctor's directions carefully. Do||
5133|069|H|not switch brands without your doctor's permission.||
5133|070|B|||
5133|071|S|SIDE EFFECTS:  Injection site reactions (pain/swelling/redness),||
5133|072|S|headache, tiredness, diarrhea, upset stomach, loss of appetite,||
5133|073|S|back pain, dizziness, dry mouth, taste changes, nausea, or||
5133|074|S|vomiting may occur. If any of these effects last or get worse,||
5133|075|S|tell your doctor or pharmacist promptly.||
5133|076|S|   Flu-like symptoms such as fever, chills, and muscle aches may||
5133|077|S|occur, especially when you first start this medication. These||
5133|078|S|symptoms usually last about 1 day after the injection and improve||
5133|079|S|or go away after a few weeks of continued use. You can reduce||
5133|080|S|these side effects by injecting this medicine at bedtime and||
5133|081|S|using a fever reducer/pain reliever such as acetaminophen before||
5133|082|S|each dose. Consult your doctor or pharmacist for more||
5133|083|S|information.||
5133|084|S|   Tooth and gum problems may sometimes occur during treatment.||
5133|085|S|Having a dry mouth can worsen this side effect. Prevent dry mouth||
5133|086|S|by drinking plenty of water or using a saliva substitute. Brush||
5133|087|S|your teeth well at least twice a day and have regular dental||
5133|088|S|exams. If you experience vomiting during treatment, rinse your||
5133|089|S|mouth afterwards to lessen the chance of tooth and gum problems.||
5133|090|S|   Temporary hair loss may occur. Normal hair growth should||
5133|091|S|return after treatment has ended.||
5133|092|S|   Remember that this medication has been prescribed because your||
5133|093|S|doctor has judged that the benefit to you is greater than the||
5133|094|S|risk of side effects. Many people using this medication do not||
5133|095|S|have serious side effects.||
5133|096|S|   Tell your doctor right away if you have any serious side||
5133|097|S|effects, including: nausea/vomiting that doesn't stop, feeling||
5133|098|S|too hot or cold (more than others around you), fast/irregular||
5133|099|S|heartbeat, increased thirst/urination, menstrual changes||
5133|100|S|(absent/delayed/irregular periods), numbness/tingling of||
5133|101|S|hands/feet, swelling (especially of face/hands/feet), trouble||
5133|102|S|sleeping, trouble walking, vision changes (such as blurred||
5133|103|S|vision, partial loss of vision), easy bleeding/bruising, signs of||
5133|104|S|infection (such as sore throat that doesn't go away, fever,||
5133|105|S|chills), stomach/abdominal pain, dark urine, black/tarry stools,||
5133|106|S|yellowing eyes/skin.||
5133|107|S|   Get medical help right away if any of these very serious side||
5133|108|S|effects occur: chest pain, seizures, weakness on one side of the||
5133|109|S|body, trouble speaking.||
5133|110|S|   This drug may cause you to develop serious mental/mood changes||
5133|111|S|that may get worse during treatment or after your last dose. Tell||
5133|112|S|your doctor right away if you have symptoms such as confusion,||
5133|113|S|depression, thoughts of suicide or hurting others, unusual||
5133|114|S|irritability, or aggressive behavior. If this occurs, psychiatric||
5133|115|S|therapy and monitoring is recommended during and after treatment||
5133|116|S|with this medication.||
5133|117|S|   A very serious allergic reaction to this drug is rare.||
5133|118|S|However, get medical help right away if you notice any symptoms||
5133|119|S|of a serious allergic reaction, including: rash, itching/swelling||
5133|120|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5133|121|S|breathing.||
5133|122|S|   This is not a complete list of possible side effects. If you||
5133|123|S|notice other effects not listed above, contact your doctor or||
5133|124|S|pharmacist.||
5133|125|S|   In the US -||
5133|126|S|   Call your doctor for medical advice about side effects. You||
5133|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5133|128|S|www.fda.gov/medwatch.||
5133|129|S|   In Canada - Call your doctor for medical advice about side||
5133|130|S|effects. You may report side effects to Health Canada at||
5133|131|S|1-866-234-2345.||
5133|132|B|||
5133|133|P|PRECAUTIONS:  See also Warning section.||
5133|134|P|   Before using interferon alfa, tell your doctor or pharmacist||
5133|135|P|if you are allergic to it; or if you have any other allergies.||
5133|136|P|This product may contain inactive ingredients (such as albumin),||
5133|137|P|which can cause allergic reactions or other problems. Talk to||
5133|138|P|your pharmacist for more details.||
5133|139|P|   Before using this medication, tell your doctor or pharmacist||
5133|140|P|your medical history, especially of: blood cell disorders (such||
5133|141|P|as anemia, neutropenia, thrombocytopenia), blood clots, cancer,||
5133|142|P|diabetes, eye problems, heart disease (such as angina, irregular||
5133|143|P|heartbeat), high blood pressure, HIV infection, immune system||
5133|144|P|diseases (such as lupus, psoriasis, rheumatoid arthritis),||
5133|145|P|intestinal disease (such as colitis), kidney disease, liver||
5133|146|P|disease (such as autoimmune hepatitis, decompensated liver||
5133|147|P|disease), lung diseases (such as chronic obstructive pulmonary||
5133|148|P|disease-COPD, asthma, pneumonia), mental/mood disorders (such as||
5133|149|P|anxiety, depression), high blood triglyceride levels,||
5133|150|P|pancreatitis, seizure disorder, thyroid disease, use/abuse of||
5133|151|P|drugs/alcohol.||
5133|152|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5133|153|P|can make you more dizzy. Do not drive, use machinery, or do||
5133|154|P|anything that needs alertness until you can do it safely. Limit||
5133|155|P|alcoholic beverages. Talk to your doctor if you are using||
5133|156|P|marijuana (cannabis).||
5133|157|P|   Tell your health care professional that you are using||
5133|158|P|interferon alfa before having any immunizations/vaccinations.||
5133|159|P|Avoid contact with people who have recently received live||
5133|160|P|vaccines (such as flu vaccine inhaled through the nose).||
5133|161|P|   To lower your risk of getting cut, bruised, or injured, use||
5133|162|P|caution with sharp objects like razors and nail cutters, and||
5133|163|P|avoid activities such as contact sports.||
5133|164|P|   Before having surgery, tell your doctor or dentist about all||
5133|165|P|the products you use (including prescription drugs,||
5133|166|P|nonprescription drugs, and herbal products).||
5133|167|P|   Children may be more sensitive to the side effects of this||
5133|168|P|drug, especially mental/mood changes (such as severe depression,||
5133|169|P|thoughts/attempts of suicide). Interferon and ribavirin may also||
5133|170|P|slow down a child's rate of growth. Normal weight gain and rate||
5133|171|P|of growth usually return after treatment is completed but the||
5133|172|P|final adult height may be lower than expected. Monitor your||
5133|173|P|child's height and weight periodically during treatment.||
5133|174|P|   Older adults may be more sensitive to the effects of the drug,||
5133|175|P|especially dizziness, mental/mood changes, and effects on the||
5133|176|P|heart.||
5133|177|P|   During pregnancy, interferon alfa should be used only when||
5133|178|P|clearly needed. Discuss the risks and benefits with your doctor.||
5133|179|P|   Interferon alfa, when used in combination with ribavirin, must||
5133|180|P|not be used during pregnancy by either the pregnant woman or her||
5133|181|P|male partner. The combination may cause harm to an unborn baby.||
5133|182|P|Reliable forms of birth control must be used whenever at least||
5133|183|P|one sexual partner is using these medicines together. Female||
5133|184|P|patients should keep using birth control for 9 months after||
5133|185|P|stopping treatment. Male patients should keep using birth control||
5133|186|P|for 6 months after stopping treatment. If you or your partner||
5133|187|P|become pregnant, or if you think you or your partner may be||
5133|188|P|pregnant, tell your doctor right away.||
5133|189|P|   It is unknown if this drug passes into breast milk. Consult||
5133|190|P|your doctor before breastfeeding.||
5133|191|B|||
5133|192|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5133|193|I|medications work or increase your risk for serious side effects.||
5133|194|I|This document does not contain all possible drug interactions.||
5133|195|I|Keep a list of all the products you use (including||
5133|196|I|prescription/nonprescription drugs and herbal products) and share||
5133|197|I|it with your doctor and pharmacist. Do not start, stop, or change||
5133|198|I|the dosage of any medicines without your doctor's approval.||
5133|199|I|   Some products that may interact with this drug include:||
5133|200|I|barbiturates (such as phenobarbital), colchicine, drugs that may||
5133|201|I|affect your immune system (such as cancer chemotherapy,||
5133|202|I|aldesleukin, cyclosporine), hydroxyurea, theophyllines (such as||
5133|203|I|aminophylline, theophylline).||
5133|204|B|||
5133|205|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5133|206|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5133|207|O|poison control center right away. US residents can call||
5133|208|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5133|209|O|Symptoms of overdose may include: nausea/vomiting that doesn't||
5133|210|O|stop, chest pain, stomach/abdominal pain, dark urine.||
5133|211|B|||
5133|212|N|NOTES:  Do not share this medication with others.||
5133|213|N|   Lab and/or medical tests (such as blood counts,||
5133|214|N|thyroid/kidney/liver function, triglyceride levels, eye exams)||
5133|215|N|should be done before you start using this medication and while||
5133|216|N|you are using it. Depending on your medical history, other tests||
5133|217|N|(such as EKG) may be needed. Keep all medical and lab||
5133|218|N|appointments. Consult your doctor for more details.||
5133|219|N|   Do not change brands of interferon without checking with your||
5133|220|N|doctor or pharmacist. Other interferons may not have the same||
5133|221|N|effects on your disease.||
5133|222|B|||
5133|223|D|MISSED DOSE:  It is important to get each dose of this medication||
5133|224|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
5133|225|D|right away for a new dosing schedule. Do not double the dose to||
5133|226|D|catch up.||
5133|227|B|||
5133|228|R|STORAGE:  Store in the refrigerator away from light and moisture.||
5133|229|R|Do not freeze. Keep all medications away from children and pets.||
5133|230|R|Consult the product instructions or your pharmacist for more||
5133|231|R|storage details once this medication is mixed.||
5133|232|R|   The multidose pen may be used for up to 4 weeks after the||
5133|233|R|first injection. Do not leave this medication outside of the||
5133|234|R|refrigerator for more than 48 hours. After 4 weeks of use,||
5133|235|R|discard the pen, even if it still contains unused solution.||
5133|236|R|   Do not flush medications down the toilet or pour them into a||
5133|237|R|drain unless instructed to do so. Properly discard this product||
5133|238|R|when it is expired or no longer needed. Consult your pharmacist||
5133|239|R|or local waste disposal company.||
5133|240|B|||
5133|241|A|Information last revised May 2025.||
5133|242|A|Copyright(c) 2025 First Databank, Inc.||
5133|243|B|||
5135|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5135|002|Z|does NOT have all possible information about this product. This||
5135|003|Z|information does not assure that this product is safe, effective,||
5135|004|Z|or appropriate for you. This information is not individual||
5135|005|Z|medical advice and does not substitute for the advice of your||
5135|006|Z|health care professional. Always ask your health care||
5135|007|Z|professional for complete information about this product and your||
5135|008|Z|specific health needs.||
5135|009|B|||
5135|010|T|IFOSFAMIDE - INJECTION||
5135|011|F|(eye-FOSS-fuh-mide)||
5135|012|B|||
5135|013|C|COMMON BRAND NAME(S): Ifex||
5135|014|B|||
5135|015|W|WARNING:  Ifosfamide may cause serious (even fatal) side effects||
5135|016|W|(including urinary problems such as hemorrhagic cystitis,||
5135|017|W|mental/mood changes, blood/bone marrow disorders), which may||
5135|018|W|require your treatment with this medication to be stopped. Tell||
5135|019|W|your doctor right away if you develop symptoms such as||
5135|020|W|pink/bloody urine, frequent/painful urination, severe drowsiness,||
5135|021|W|confusion, unusual changes in behavior, or hallucinations.||
5135|022|W|Blood/bone marrow disorders can affect your body's ability to||
5135|023|W|stop bleeding, or fight infection. Tell your doctor right away if||
5135|024|W|you develop easy bruising/bleeding or signs of infection (such as||
5135|025|W|sore throat that doesn't go away, fever, chills).||
5135|026|B|||
5135|027|U|USES:  Ifosfamide is used to treat various cancers. It works by||
5135|028|U|slowing or stopping the growth of cancer cells.||
5135|029|B|||
5135|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5135|031|H|from your pharmacist before you start using ifosfamide and each||
5135|032|H|time you get a refill. If you have any questions, ask your doctor||
5135|033|H|or pharmacist.||
5135|034|H|   This medication is given by a health care professional. It is||
5135|035|H|injected slowly into a vein over 30 minutes. The dosage is based||
5135|036|H|on your medical condition, body size, and response to treatment.||
5135|037|H|   If this medication touches your skin, immediately wash the||
5135|038|H|area well with soap and water. If this medication gets in your||
5135|039|H|eye, open the eyelid and flush with water for 15 minutes, then||
5135|040|H|get medical help right away.||
5135|041|H|   To help prevent urinary problems, drink plenty of fluids and||
5135|042|H|urinate often unless otherwise directed by your doctor. Your||
5135|043|H|doctor may also prescribe other medication (such as mesna,||
5135|044|H|intravenous fluids) to decrease the risk.||
5135|045|B|||
5135|046|S|SIDE EFFECTS:  See also Warning section.||
5135|047|S|   Nausea, vomiting, diarrhea, stomach/abdominal pain, loss of||
5135|048|S|appetite, or redness/pain/swelling at the injection site may||
5135|049|S|occur. Nausea and vomiting can be severe. In some cases, your||
5135|050|S|doctor may prescribe medication to prevent or relieve nausea and||
5135|051|S|vomiting. Eating several small meals, not eating before||
5135|052|S|treatment, avoiding alcoholic beverages, or limiting activity may||
5135|053|S|help lessen some of these effects. If these effects last or get||
5135|054|S|worse, tell your doctor or pharmacist promptly.||
5135|055|S|   Severe nausea, vomiting, and diarrhea may rarely cause||
5135|056|S|dehydration. Contact your doctor promptly if you notice any||
5135|057|S|symptoms of dehydration such as unusual decreased urination,||
5135|058|S|unusual dry mouth/increased thirst, lack of tears,||
5135|059|S|dizziness/lightheadedness, or pale/wrinkled skin.||
5135|060|S|   Pain or sores in the mouth and throat may occur. Brush your||
5135|061|S|teeth gently/carefully, avoid using mouthwash that contains||
5135|062|S|alcohol, and rinse your mouth often with cool water mixed with||
5135|063|S|baking soda or salt. It may also be best to eat soft, moist||
5135|064|S|foods.||
5135|065|S|   Temporary hair loss may occur. Normal hair growth should||
5135|066|S|return after treatment has ended.||
5135|067|S|   People using this medication may have serious side effects.||
5135|068|S|However, you have been prescribed this drug because your doctor||
5135|069|S|has judged that the benefit to you is greater than the risk of||
5135|070|S|side effects. Careful monitoring by your doctor may decrease your||
5135|071|S|risk.||
5135|072|S|   Tell your doctor right away if you have any serious side||
5135|073|S|effects, including: numbness/tingling in the hands/feet, signs of||
5135|074|S|heart problems (such as fast/slow/irregular heartbeat, shortness||
5135|075|S|of breath, swelling ankles/feet, unusual tiredness,||
5135|076|S|unusual/sudden weight gain), change in the amount of urine,||
5135|077|S|vision changes (such as decreased/blurred vision),||
5135|078|S|irregular/stopped menstrual periods (women).||
5135|079|S|   Rarely, people who are treated with this medication have||
5135|080|S|developed other cancers (such as leukemia). Talk with your doctor||
5135|081|S|for more details.||
5135|082|S|   Get medical help right away if you have any very serious side||
5135|083|S|effects, including: seizure.||
5135|084|S|   A very serious allergic reaction to this drug is rare.||
5135|085|S|However, get medical help right away if you notice any symptoms||
5135|086|S|of a serious allergic reaction, including: rash, itching/swelling||
5135|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5135|088|S|breathing.||
5135|089|S|   This is not a complete list of possible side effects. If you||
5135|090|S|notice other effects not listed above, contact your doctor or||
5135|091|S|pharmacist.||
5135|092|S|   In the US -||
5135|093|S|   Call your doctor for medical advice about side effects. You||
5135|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5135|095|S|www.fda.gov/medwatch.||
5135|096|S|   In Canada - Call your doctor for medical advice about side||
5135|097|S|effects. You may report side effects to Health Canada at||
5135|098|S|1-866-234-2345.||
5135|099|B|||
5135|100|P|PRECAUTIONS:  Before using ifosfamide, tell your doctor or||
5135|101|P|pharmacist if you are allergic to it; or if you have any other||
5135|102|P|allergies. This product may contain inactive ingredients, which||
5135|103|P|can cause allergic reactions or other problems. Talk to your||
5135|104|P|pharmacist for more details.||
5135|105|P|   Before using this medication, tell your doctor or pharmacist||
5135|106|P|your medical history, especially of: blood/bleeding problems||
5135|107|P|(such as anemia, low blood cell counts), current infection, heart||
5135|108|P|problems (such as fast/irregular heartbeat, heart failure),||
5135|109|P|kidney disease, liver disease, radiation treatment, problems with||
5135|110|P|urination (such as blockage).||
5135|111|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
5135|112|P|can make you more drowsy. Do not drive, use machinery, or do||
5135|113|P|anything that needs alertness until you can do it safely. Limit||
5135|114|P|alcoholic beverages. Talk to your doctor if you are using||
5135|115|P|marijuana (cannabis).||
5135|116|P|   Ifosfamide can make you more likely to get infections or may||
5135|117|P|make current infections worse. Stay away from anyone who has an||
5135|118|P|infection that may easily spread (such as chickenpox, COVID-19,||
5135|119|P|measles, flu). Talk to your doctor if you have been exposed to an||
5135|120|P|infection or for more details.||
5135|121|P|   Tell your health care professional that you are using||
5135|122|P|ifosfamide before having any immunizations/vaccinations. Avoid||
5135|123|P|contact with people who have recently received live vaccines||
5135|124|P|(such as flu vaccine inhaled through the nose).||
5135|125|P|   This medication may make a wound heal more slowly than usual.||
5135|126|P|To lower your risk of getting cut, bruised, or injured, use||
5135|127|P|caution with sharp objects like razors and nail cutters, and||
5135|128|P|avoid activities such as contact sports.||
5135|129|P|   Before having surgery, tell your doctor or dentist about all||
5135|130|P|the products you use (including prescription drugs,||
5135|131|P|nonprescription drugs, and herbal products).||
5135|132|P|   This medication can affect fertility in both males and||
5135|133|P|females. Ask your doctor for more details.||
5135|134|P|   Tell your doctor if you are pregnant or plan to become||
5135|135|P|pregnant. You should not become pregnant while using ifosfamide.||
5135|136|P|Ifosfamide may harm an unborn baby. Your doctor should order a||
5135|137|P|pregnancy test before you start this medication. Women using this||
5135|138|P|medication should ask about reliable forms of birth control||
5135|139|P|during treatment and for 12 months after the last dose. Men using||
5135|140|P|this medication should ask about reliable forms of birth control||
5135|141|P|during treatment and for 6 months after the last dose. If you or||
5135|142|P|your partner becomes pregnant, talk to your doctor right away||
5135|143|P|about the risks and benefits of this medication.||
5135|144|P|   This medication passes into breast milk and may have||
5135|145|P|undesirable effects on a nursing infant. Breastfeeding is not||
5135|146|P|recommended while using this medication and for 1 week after the||
5135|147|P|last dose. Consult your doctor before breastfeeding.||
5135|148|B|||
5135|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5135|150|I|medications work or increase your risk for serious side effects.||
5135|151|I|This document does not contain all possible drug interactions.||
5135|152|I|Keep a list of all the products you use (including||
5135|153|I|prescription/nonprescription drugs and herbal products) and share||
5135|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
5135|155|I|the dosage of any medicines without your doctor's approval.||
5135|156|B|||
5135|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5135|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5135|159|O|poison control center right away. US residents can call||
5135|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5135|161|B|||
5135|162|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
5135|163|N|blood salt/mineral levels, kidney function) should be done before||
5135|164|N|you start using this medication and while you are using it. Keep||
5135|165|N|all medical and lab appointments. Consult your doctor for more||
5135|166|N|details.||
5135|167|B|||
5135|168|D|MISSED DOSE:  It is important to get each dose of this medication||
5135|169|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
5135|170|D|right away for a new dosing schedule.||
5135|171|B|||
5135|172|R|STORAGE:  Not applicable. This medication is given in a hospital||
5135|173|R|or clinic and will not be stored at home.||
5135|174|B|||
5135|175|M|MEDICAL ALERT:  Your condition can cause complications in a||
5135|176|M|medical emergency. For information about enrolling in MedicAlert,||
5135|177|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5135|178|B|||
5135|179|A|Information last revised December 2024.||
5135|180|A|Copyright(c) 2025 First Databank, Inc.||
5135|181|B|||
5136|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5136|002|Z|does NOT have all possible information about this product. This||
5136|003|Z|information does not assure that this product is safe, effective,||
5136|004|Z|or appropriate for you. This information is not individual||
5136|005|Z|medical advice and does not substitute for the advice of your||
5136|006|Z|health care professional. Always ask your health care||
5136|007|Z|professional for complete information about this product and your||
5136|008|Z|specific health needs.||
5136|009|B|||
5136|010|T|FLUDARABINE - INJECTION||
5136|011|F|(flew-DARE-uh-bean)||
5136|012|B|||
5136|013|C|COMMON BRAND NAME(S): Fludara||
5136|014|B|||
5136|015|U|USES:  This medication is used to treat leukemia and other||
5136|016|U|cancers. It works by slowing or stopping the growth of cancer||
5136|017|U|cells.||
5136|018|B|||
5136|019|H|HOW TO USE:  This medication is given by a health care||
5136|020|H|professional. It is injected slowly into a vein over 30 minutes.||
5136|021|H|   The dosage is based on your medical condition, body size, and||
5136|022|H|response to treatment. Your doctor will check your blood counts||
5136|023|H|to make sure you can receive your next cycle. Keep all||
5136|024|H|medical/lab appointments.||
5136|025|H|   If this medication touches your skin, immediately wash the||
5136|026|H|area well with soap and water. If this medication gets in your||
5136|027|H|eye, open the eyelid and flush with water, then get medical help||
5136|028|H|right away.||
5136|029|B|||
5136|030|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, muscle||
5136|031|S|aches, tiredness, loss of appetite, and pain/redness at the||
5136|032|S|injection site may occur. Nausea and vomiting can be severe. In||
5136|033|S|some cases, your doctor may prescribe medication to prevent or||
5136|034|S|relieve nausea and vomiting. Eating several small meals, not||
5136|035|S|eating before treatment, or limiting activity may help lessen||
5136|036|S|some of these effects. If any of these effects last or get worse,||
5136|037|S|tell your doctor or pharmacist promptly.||
5136|038|S|   Many people using this medication may have serious side||
5136|039|S|effects. However, you have been prescribed this drug because your||
5136|040|S|doctor has judged that the benefit to you is greater than the||
5136|041|S|risk of side effects. Careful monitoring by your doctor may||
5136|042|S|decrease your risk.||
5136|043|S|   Pain or sores in the mouth and throat may occur. Brush your||
5136|044|S|teeth gently/carefully, avoid using mouthwash that contains||
5136|045|S|alcohol, and rinse your mouth often with cool water mixed with||
5136|046|S|baking soda or salt. It may also be best to eat soft, moist||
5136|047|S|foods.||
5136|048|S|   Tell your doctor right away if you have any serious side||
5136|049|S|effects, including: easy bleeding/bruising, fast/irregular||
5136|050|S|heartbeat, swelling ankles/feet.||
5136|051|S|   Fludarabine may rarely cause severe (sometimes fatal) central||
5136|052|S|nervous system problems. Symptoms may not occur until weeks after||
5136|053|S|your last treatment. Tell your doctor right away if you notice||
5136|054|S|any vision changes, seizures, agitation, confusion, or||
5136|055|S|numbness/tingling.||
5136|056|S|   This medication may lower your ability to fight infections.||
5136|057|S|This may make you more likely to get a serious (rarely fatal)||
5136|058|S|infection or make any infection you have worse. Tell your doctor||
5136|059|S|right away if you have any signs of infection (such as sore||
5136|060|S|throat that doesn't go away, fever, chills).||
5136|061|S|   Fludarabine sometimes causes side effects due to the rapid||
5136|062|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
5136|063|S|risk, your doctor may add a medication and tell you to drink||
5136|064|S|plenty of fluids. Tell your doctor right away if you have||
5136|065|S|symptoms such as: low back/side pain (flank pain), signs of||
5136|066|S|kidney problems (such as painful urination, pink/bloody urine,||
5136|067|S|change in the amount of urine), muscle spasms/weakness.||
5136|068|S|   Get medical help right away if you have any very serious side||
5136|069|S|effects, including: cough that doesn't go away,||
5136|070|S|bloody/black/tarry stool, coughing up blood, painful/difficult||
5136|071|S|breathing, chest pain.||
5136|072|S|   A very serious allergic reaction to this drug is rare.||
5136|073|S|However, get medical help right away if you notice any symptoms||
5136|074|S|of a serious allergic reaction, including: rash, itching/swelling||
5136|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5136|076|S|breathing.||
5136|077|S|   This is not a complete list of possible side effects. If you||
5136|078|S|notice other effects not listed above, contact your doctor or||
5136|079|S|pharmacist.||
5136|080|S|   In the US -||
5136|081|S|   Call your doctor for medical advice about side effects. You||
5136|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5136|083|S|www.fda.gov/medwatch.||
5136|084|S|   In Canada - Call your doctor for medical advice about side||
5136|085|S|effects. You may report side effects to Health Canada at||
5136|086|S|1-866-234-2345.||
5136|087|B|||
5136|088|P|PRECAUTIONS:  Before using fludarabine, tell your doctor or||
5136|089|P|pharmacist if you are allergic to it; or if you have any other||
5136|090|P|allergies. This product may contain inactive ingredients, which||
5136|091|P|can cause allergic reactions or other problems. Talk to your||
5136|092|P|pharmacist for more details.||
5136|093|P|   Before using this medication, tell your doctor or pharmacist||
5136|094|P|your medical history, especially of: current infections, certain||
5136|095|P|virus illnesses (herpes, chickenpox), blood disorders (such as||
5136|096|P|anemia, clotting problems), kidney problems.||
5136|097|P|   Tell your health care professional that you are using||
5136|098|P|fludarabine before having any immunizations/vaccinations. Avoid||
5136|099|P|contact with people who have recently received live vaccines||
5136|100|P|(such as flu vaccine inhaled through the nose).||
5136|101|P|   Fludarabine can make you more likely to get infections or may||
5136|102|P|make current infections worse. Stay away from anyone who has an||
5136|103|P|infection that may easily spread (such as chickenpox, COVID-19,||
5136|104|P|measles, flu). Talk to your doctor if you have been exposed to an||
5136|105|P|infection or for more details.||
5136|106|P|   To lower your chance of getting cut, bruised, or injured, use||
5136|107|P|caution with sharp objects like razors and nail cutters, and||
5136|108|P|avoid activities such as contact sports.||
5136|109|P|   Older adults may be at greater risk for side effects (such as||
5136|110|P|infection, bleeding) while using this drug.||
5136|111|P|   Tell your doctor if you are pregnant or plan to become||
5136|112|P|pregnant. You should not become pregnant while using fludarabine.||
5136|113|P|Fludarabine may harm an unborn baby. Your doctor should order a||
5136|114|P|pregnancy test before you start this medication. Women using this||
5136|115|P|medication should ask about reliable forms of birth control||
5136|116|P|during treatment and for 6 months after the last dose. Men using||
5136|117|P|this medication should ask about reliable forms of birth control||
5136|118|P|during treatment and for some time after the last dose. If you or||
5136|119|P|your partner becomes pregnant, talk to your doctor right away||
5136|120|P|about the risks and benefits of this medication.||
5136|121|P|   It is unknown if this medication passes into breast milk.||
5136|122|P|Because of the possible risk to the infant, breastfeeding is not||
5136|123|P|recommended while using this medication and for 1 week after the||
5136|124|P|last dose. Consult your doctor before breastfeeding.||
5136|125|B|||
5136|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5136|127|I|medications work or increase your risk for serious side effects.||
5136|128|I|This document does not contain all possible drug interactions.||
5136|129|I|Keep a list of all the products you use (including||
5136|130|I|prescription/nonprescription drugs and herbal products) and share||
5136|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
5136|132|I|the dosage of any medicines without your doctor's approval.||
5136|133|I|   Some products that may interact with this drug include: "blood||
5136|134|I|thinners" (such as warfarin, enoxaparin), live vaccines (such as||
5136|135|I|flu vaccine inhaled through the nose, typhoid/polio vaccine taken||
5136|136|I|by mouth), pentostatin, other drugs that weaken the immune||
5136|137|I|system/increase the risk of infection (such as natalizumab,||
5136|138|I|rituximab), salicylates/NSAIDs (such as aspirin, ibuprofen,||
5136|139|I|naproxen).||
5136|140|I|   Check all prescription and nonprescription medicine labels||
5136|141|I|carefully since many contain pain relievers/fever reducers||
5136|142|I|(NSAIDs such as ibuprofen, naproxen, and aspirin) that can||
5136|143|I|increase your risk of bleeding. However, if your doctor has told||
5136|144|I|you to take low-dose aspirin to prevent heart attack or stroke||
5136|145|I|(usually 81-162 milligrams a day), you should keep taking the||
5136|146|I|aspirin unless your doctor tells you not to. Ask your doctor or||
5136|147|I|pharmacist for more details.||
5136|148|B|||
5136|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5136|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5136|151|O|poison control center right away. US residents can call||
5136|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5136|153|B|||
5136|154|N|NOTES:  Lab and/or medical tests (such as complete blood count)||
5136|155|N|should be done while you are using this medication. Keep all||
5136|156|N|medical and lab appointments. Consult your doctor for more||
5136|157|N|details.||
5136|158|B|||
5136|159|D|MISSED DOSE:  It is important to get each dose of this medication||
5136|160|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
5136|161|D|right away for a new dosing schedule.||
5136|162|B|||
5136|163|R|STORAGE:  Consult the product instructions and your pharmacist||
5136|164|R|for storage details. Keep all medications away from children and||
5136|165|R|pets.||
5136|166|R|   Do not flush medications down the toilet or pour them into a||
5136|167|R|drain unless instructed to do so. Properly discard this product||
5136|168|R|when it is expired or no longer needed. Consult your pharmacist||
5136|169|R|or local waste disposal company.||
5136|170|B|||
5136|171|M|MEDICAL ALERT:  Your condition can cause complications in a||
5136|172|M|medical emergency. For information about enrolling in MedicAlert,||
5136|173|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5136|174|B|||
5136|175|A|Information last revised May 2025.||
5136|176|A|Copyright(c) 2025 First Databank, Inc.||
5136|177|B|||
5137|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5137|002|Z|does NOT have all possible information about this product. This||
5137|003|Z|information does not assure that this product is safe, effective,||
5137|004|Z|or appropriate for you. This information is not individual||
5137|005|Z|medical advice and does not substitute for the advice of your||
5137|006|Z|health care professional. Always ask your health care||
5137|007|Z|professional for complete information about this product and your||
5137|008|Z|specific health needs.||
5137|009|B|||
5137|010|T|LEUPROLIDE MONTHLY (3.75 MG) - INJECTION||
5137|011|F|(LOO-proe-lide)||
5137|012|B|||
5137|013|C|COMMON BRAND NAME(S): Lupron Depot||
5137|014|B|||
5137|015|U|USES:  Leuprolide is used to treat certain disorders (such as||
5137|016|U|endometriosis, uterine fibroids). For the treatment of uterine||
5137|017|U|fibroids, leuprolide is usually given with iron to help improve||
5137|018|U|anemia that is caused by too much vaginal bleeding. Leuprolide||
5137|019|U|helps to reduce symptoms such as pelvic pain, painful/heavy||
5137|020|U|menstrual periods, and abdominal bloating. It works by shrinking||
5137|021|U|the abnormal tissue that causes these symptoms. The abnormal||
5137|022|U|tissue needs the hormone estrogen to grow and spread. Leuprolide||
5137|023|U|helps to decrease the amount of estrogen that is made in the||
5137|024|U|body.||
5137|025|B|||
5137|026|V|OTHER USES:  This section contains uses of this drug that are not||
5137|027|V|listed in the approved professional labeling for the drug but||
5137|028|V|that may be prescribed by your health care professional. Use this||
5137|029|V|drug for a condition that is listed in this section only if it||
5137|030|V|has been so prescribed by your health care professional.||
5137|031|V|   This drug may also be used for prostate cancer.||
5137|032|B|||
5137|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5137|034|H|from your pharmacist before you start using leuprolide and each||
5137|035|H|time you get a refill. If you have any questions, ask your doctor||
5137|036|H|or pharmacist.||
5137|037|H|   This medication is given by injection into a muscle by a||
5137|038|H|health care professional. It is given as directed by your doctor,||
5137|039|H|usually once every month. This product slowly releases the||
5137|040|H|medication into your blood over a 1-month period.||
5137|041|H|   The length of treatment is based on your medical condition,||
5137|042|H|response to treatment, and lab tests.||
5137|043|H|   Use this medication regularly to get the most benefit from it.||
5137|044|H|To help you remember, mark your calendar with a reminder.||
5137|045|H|   During the first few weeks of treatment, your hormone levels||
5137|046|H|will actually go up before they go down. This is a normal||
5137|047|H|response to this medication. Your symptoms may get worse for a||
5137|048|H|few weeks.||
5137|049|H|   Tell your doctor if your condition does not get better or if||
5137|050|H|it gets worse. It may take at least 3 months for your symptoms to||
5137|051|H|get better.||
5137|052|B|||
5137|053|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
5137|054|S|sweats, tiredness, headache, upset stomach, breast changes, acne,||
5137|055|S|joint/muscle aches, trouble sleeping, reduced sexual interest,||
5137|056|S|vaginal discomfort/dryness, swelling of the ankles/feet,||
5137|057|S|dizziness, or mild burning/pain/bruising at the injection site||
5137|058|S|may occur. If any of these effects last or get worse, tell your||
5137|059|S|doctor or pharmacist promptly.||
5137|060|S|   When this medication is used regularly, your menstrual period||
5137|061|S|should stop (or bleeding should get lighter). Menstrual periods||
5137|062|S|usually return within 3 months after treatment is stopped. Tell||
5137|063|S|your doctor promptly if regular periods continue during treatment||
5137|064|S|with leuprolide.||
5137|065|S|   Remember that this medication has been prescribed because your||
5137|066|S|doctor has judged that the benefit to you is greater than the||
5137|067|S|risk of side effects. Many people using this medication do not||
5137|068|S|have serious side effects.||
5137|069|S|   Tell your doctor right away if you have any serious side||
5137|070|S|effects, including: mental/mood changes (such as depression,||
5137|071|S|thoughts of suicide, mood swings, aggression), new/worsening bone||
5137|072|S|pain, easily broken bones.||
5137|073|S|   Get medical help right away if you have any very serious side||
5137|074|S|effects, including: seizures.||
5137|075|S|   A very serious allergic reaction to this drug is rare.||
5137|076|S|However, get medical help right away if you notice any symptoms||
5137|077|S|of a serious allergic reaction, including: fever, swollen lymph||
5137|078|S|nodes, rash, itching/swelling (especially of the||
5137|079|S|face/tongue/throat), severe dizziness, trouble breathing.||
5137|080|S|   This is not a complete list of possible side effects. If you||
5137|081|S|notice other effects not listed above, contact your doctor or||
5137|082|S|pharmacist.||
5137|083|S|   In the US -||
5137|084|S|   Call your doctor for medical advice about side effects. You||
5137|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5137|086|S|www.fda.gov/medwatch.||
5137|087|S|   In Canada - Call your doctor for medical advice about side||
5137|088|S|effects. You may report side effects to Health Canada at||
5137|089|S|1-866-234-2345.||
5137|090|B|||
5137|091|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
5137|092|P|pharmacist if you are allergic to it; or to similar drugs (such||
5137|093|P|as histrelin, triptorelin); or if you have any other allergies.||
5137|094|P|This product may contain inactive ingredients, which can cause||
5137|095|P|allergic reactions or other problems. Talk to your pharmacist for||
5137|096|P|more details.||
5137|097|P|   Before using this medication, tell your doctor or pharmacist||
5137|098|P|your medical history, especially of: high blood fat levels (such||
5137|099|P|as high cholesterol/triglycerides), mental/mood problems (such as||
5137|100|P|depression), vaginal bleeding of unknown cause, seizures.||
5137|101|P|   Leuprolide may weaken your bones and increase your risk for||
5137|102|P|bone loss (osteoporosis) if used for a long time. Before using||
5137|103|P|this medication, tell your doctor or pharmacist if you have||
5137|104|P|osteoporosis or if you have any of the following risk factors for||
5137|105|P|osteoporosis: long-term alcohol use, smoking, family history of||
5137|106|P|osteoporosis and broken bones, use of certain medications (for||
5137|107|P|example, corticosteroids such as prednisone, certain anti-seizure||
5137|108|P|drugs such as phenytoin).||
5137|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5137|110|P|can make you more dizzy. Do not drive, use machinery, or do||
5137|111|P|anything that needs alertness until you can do it safely. Limit||
5137|112|P|alcoholic beverages. Talk to your doctor if you are using||
5137|113|P|marijuana (cannabis).||
5137|114|P|   This medication must not be used during pregnancy. It may harm||
5137|115|P|an unborn baby. It is important to prevent pregnancy while using||
5137|116|P|this medication. Consult your doctor for more details and to||
5137|117|P|discuss using reliable forms of non-hormonal birth control (such||
5137|118|P|as condoms, diaphragm with spermicide) while using this||
5137|119|P|medication. If you become pregnant or think you may be pregnant,||
5137|120|P|tell your doctor right away.||
5137|121|P|   It is unknown if leuprolide passes into breast milk. Because||
5137|122|P|of the possible risk to the infant, breastfeeding is not||
5137|123|P|recommended while using this medication. Consult your doctor||
5137|124|P|before breastfeeding.||
5137|125|B|||
5137|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5137|127|I|medications work or increase your risk for serious side effects.||
5137|128|I|This document does not contain all possible drug interactions.||
5137|129|I|Keep a list of all the products you use (including||
5137|130|I|prescription/nonprescription drugs and herbal products) and share||
5137|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
5137|132|I|the dosage of any medicines without your doctor's approval.||
5137|133|I|   This medication may interfere with certain lab tests, possibly||
5137|134|I|causing false test results. Make sure lab personnel and all your||
5137|135|I|doctors know you use this drug.||
5137|136|B|||
5137|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5137|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5137|139|O|poison control center right away. US residents can call||
5137|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5137|141|B|||
5137|142|N|NOTES:  Do not share this medication with others.||
5137|143|N|   Lab and/or medical tests (such as hormone levels, bone tests,||
5137|144|N|cholesterol/triglyceride blood levels) should be done while you||
5137|145|N|are using this medication. Keep all medical and lab appointments.||
5137|146|N|Consult your doctor for more details.||
5137|147|B|||
5137|148|D|MISSED DOSE:  It is important to get each dose of this medication||
5137|149|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
5137|150|D|right away for a new dosing schedule. Do not double the dose to||
5137|151|D|catch up.||
5137|152|B|||
5137|153|R|STORAGE:  Not applicable. This medication is given in a clinic or||
5137|154|R|doctor's office and will not be stored at home.||
5137|155|B|||
5137|156|A|Information last revised October 2024.||
5137|157|A|Copyright(c) 2025 First Databank, Inc.||
5137|158|B|||
5138|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5138|002|Z|does NOT have all possible information about this product. This||
5138|003|Z|information does not assure that this product is safe, effective,||
5138|004|Z|or appropriate for you. This information is not individual||
5138|005|Z|medical advice and does not substitute for the advice of your||
5138|006|Z|health care professional. Always ask your health care||
5138|007|Z|professional for complete information about this product and your||
5138|008|Z|specific health needs.||
5138|009|B|||
5138|010|T|STAVUDINE - ORAL||
5138|011|F|(STAV-you-deen)||
5138|012|B|||
5138|013|C|COMMON BRAND NAME(S): Zerit||
5138|014|B|||
5138|015|W|WARNING:  Rarely, stavudine has caused a severe (sometimes fatal)||
5138|016|W|pancreas problem (pancreatitis) when used alone or with other HIV||
5138|017|W|medicines. Immediately tell your doctor if you develop symptoms||
5138|018|W|of pancreatitis (such as nausea/vomiting that doesn't stop,||
5138|019|W|stomach/abdominal/back pain).||
5138|020|W|   Rarely, stavudine has caused a severe (sometimes fatal) liver||
5138|021|W|and blood problem (lactic acidosis). Tell your doctor right away||
5138|022|W|if you develop symptoms of liver problems (such as nausea that||
5138|023|W|doesn't stop, stomach/abdominal pain, dark urine, yellowing||
5138|024|W|eyes/skin) or lactic acidosis (such as rapid breathing,||
5138|025|W|drowsiness, muscle aches). Pregnant women with HIV may be more||
5138|026|W|likely to have this problem.||
5138|027|W|   Do not use stavudine with didanosine because of the increased||
5138|028|W|risk of serious side effects.||
5138|029|B|||
5138|030|U|USES:  This drug is used with other HIV medications to help||
5138|031|U|control HIV infection. It helps to decrease the amount of HIV in||
5138|032|U|your body so your immune system can work better. This lowers your||
5138|033|U|chance of getting HIV complications (such as new infections,||
5138|034|U|cancer) and improves your quality of life. Stavudine belongs to a||
5138|035|U|class of drugs known as nucleoside reverse transcriptase||
5138|036|U|inhibitors (NRTI).||
5138|037|U|   Stavudine is not a cure for HIV infection. To decrease your||
5138|038|U|risk of spreading HIV disease to others, continue to take all HIV||
5138|039|U|medications exactly as prescribed by your doctor. Use an||
5138|040|U|effective barrier method (latex or polyurethane condoms/dental||
5138|041|U|dams) during sexual activity as directed by your doctor. Do not||
5138|042|U|share personal items (such as needles/syringes, toothbrushes, and||
5138|043|U|razors) that may have contacted blood or other body fluids.||
5138|044|U|Consult your doctor or pharmacist for more details.||
5138|045|B|||
5138|046|V|OTHER USES:  This section contains uses of this drug that are not||
5138|047|V|listed in the approved professional labeling for the drug but||
5138|048|V|that may be prescribed by your health care professional. Use this||
5138|049|V|drug for a condition that is listed in this section only if it||
5138|050|V|has been so prescribed by your health care professional.||
5138|051|V|   This product may also be used to lessen the risk of HIV||
5138|052|V|infection after contact with the virus (for example, due to a||
5138|053|V|needle stick). Ask your doctor for more details.||
5138|054|B|||
5138|055|H|HOW TO USE:  Read the Medication Guide and, if available, the||
5138|056|H|Patient Information Leaflet provided by your pharmacist before||
5138|057|H|you start using stavudine and each time you get a refill. If you||
5138|058|H|have any questions, ask your doctor or pharmacist.||
5138|059|H|   Take this medication by mouth with or without food as directed||
5138|060|H|by your doctor, usually every 12 hours.||
5138|061|H|   The dosage is based on your weight, medical condition, and||
5138|062|H|response to treatment.||
5138|063|H|   For the best effect, take this medication at evenly spaced||
5138|064|H|times. To help you remember, take this medication at the same||
5138|065|H|times every day.||
5138|066|H|   It is very important to keep taking this medication (and other||
5138|067|H|HIV medications) exactly as prescribed by your doctor. Do not||
5138|068|H|skip any doses. Refill your medication before you run out.||
5138|069|H|   Do not take more or less of this drug than prescribed or stop||
5138|070|H|taking it (or other HIV medicines) even for a short time unless||
5138|071|H|directed to do so by your doctor. Skipping or changing your dose||
5138|072|H|without approval from your doctor may cause the amount of virus||
5138|073|H|to increase, make the infection more difficult to treat||
5138|074|H|(resistant), or worsen side effects.||
5138|075|B|||
5138|076|S|SIDE EFFECTS:  See also Warning section.||
5138|077|S|   Headache or diarrhea may occur. If any of these effects last||
5138|078|S|or get worse, tell your doctor or pharmacist promptly.||
5138|079|S|   Remember that this medication has been prescribed because your||
5138|080|S|doctor has judged that the benefit to you is greater than the||
5138|081|S|risk of side effects. Many people using this medication do not||
5138|082|S|have serious side effects.||
5138|083|S|   As your immune system gets stronger, it can begin to fight off||
5138|084|S|infections you already had, possibly causing disease symptoms to||
5138|085|S|come back. You could also have symptoms if your immune system||
5138|086|S|becomes overactive. This reaction may happen at any time (soon||
5138|087|S|after starting HIV treatment or many months later). Tell your||
5138|088|S|doctor right away if you have any serious symptoms, including:||
5138|089|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
5138|090|S|that doesn't go away, headaches that are severe or don't go away,||
5138|091|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
5138|092|S|changes, signs of infection (such as sore throat that doesn't go||
5138|093|S|away, fever, chills, swollen lymph nodes, non-healing skin||
5138|094|S|sores), signs of an overactive thyroid (such as irritability,||
5138|095|S|nervousness, heat intolerance, fast/pounding/irregular||
5138|096|S|heartbeat).||
5138|097|S|   This medication can cause severe nerve problems in the||
5138|098|S|hands/feet/legs (peripheral neuropathy). Symptoms may include||
5138|099|S|numbness/tingling/pain, muscle weakness, or decreased muscle||
5138|100|S|control. If you experience any of these symptoms, contact your||
5138|101|S|doctor right away so that you can be monitored closely. Your||
5138|102|S|doctor may decide to reduce or stop your dose of stavudine.||
5138|103|S|   Changes in body fat (such as increased fat in the upper back||
5138|104|S|and stomach areas, decreased fat in the arms and legs) may occur||
5138|105|S|while you are taking HIV medication. The cause and long-term||
5138|106|S|effects of these changes are unknown. Discuss the risks and||
5138|107|S|benefits of therapy with your doctor, as well as the possible||
5138|108|S|role of exercise to reduce this side effect.||
5138|109|S|   A very serious allergic reaction to this drug is rare.||
5138|110|S|However, get medical help right away if you notice any symptoms||
5138|111|S|of a serious allergic reaction, including: rash, itching/swelling||
5138|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5138|113|S|breathing.||
5138|114|S|   This is not a complete list of possible side effects. If you||
5138|115|S|notice other effects not listed above, contact your doctor or||
5138|116|S|pharmacist.||
5138|117|S|   In the US -||
5138|118|S|   Call your doctor for medical advice about side effects. You||
5138|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5138|120|S|www.fda.gov/medwatch.||
5138|121|S|   In Canada - Call your doctor for medical advice about side||
5138|122|S|effects. You may report side effects to Health Canada at||
5138|123|S|1-866-234-2345.||
5138|124|B|||
5138|125|P|PRECAUTIONS:  Before taking stavudine, tell your doctor or||
5138|126|P|pharmacist if you are allergic to it; or if you have any other||
5138|127|P|allergies. This product may contain inactive ingredients, which||
5138|128|P|can cause allergic reactions or other problems. Talk to your||
5138|129|P|pharmacist for more details.||
5138|130|P|   Before using this medication, tell your doctor or pharmacist||
5138|131|P|your medical history, especially of: pancreatitis, kidney||
5138|132|P|problems, liver problems (such as hepatitis, cirrhosis), nerve||
5138|133|P|problems (such as peripheral neuropathy), alcohol use, gall||
5138|134|P|bladder problems (such as gall stones).||
5138|135|P|   Avoid alcoholic beverages because they may increase your risk||
5138|136|P|for liver problems and/or pancreatitis.||
5138|137|P|   Before having surgery, tell your doctor or dentist about all||
5138|138|P|the products you use (including prescription drugs,||
5138|139|P|nonprescription drugs, and herbal products).||
5138|140|P|   Older adults may be more sensitive to the side effects of this||
5138|141|P|drug, especially the increased risk of nerve problems.||
5138|142|P|   Tell your doctor if you are pregnant before using this||
5138|143|P|medication. Treatment can lower the risk of passing HIV infection||
5138|144|P|to your baby. Discuss the risks and benefits with your doctor.||
5138|145|P|   This medication passes into breast milk. Because breast milk||
5138|146|P|may transmit HIV, consult your doctor before breastfeeding.||
5138|147|B|||
5138|148|I|DRUG INTERACTIONS:  See also Warning section.||
5138|149|I|   Drug interactions may change how your medications work or||
5138|150|I|increase your risk for serious side effects. This document does||
5138|151|I|not contain all possible drug interactions. Keep a list of all||
5138|152|I|the products you use (including prescription/nonprescription||
5138|153|I|drugs and herbal products) and share it with your doctor and||
5138|154|I|pharmacist. Do not start, stop, or change the dosage of any||
5138|155|I|medicines without your doctor's approval.||
5138|156|I|   Some products that may interact with this drug include:||
5138|157|I|didanosine, doxorubicin, hydroxyurea, orlistat, zidovudine, drugs||
5138|158|I|that can cause nerve problems (such as isoniazid, vincristine).||
5138|159|B|||
5138|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5138|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5138|162|O|poison control center right away. US residents can call||
5138|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5138|164|B|||
5138|165|N|NOTES:  Do not share this medication with others.||
5138|166|N|   Lab and/or medical tests (such as kidney function, liver||
5138|167|N|tests, viral load, T-cell counts) should be done while you are||
5138|168|N|taking this medication. Keep all medical and lab appointments.||
5138|169|N|Consult your doctor for more details.||
5138|170|B|||
5138|171|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5138|172|D|remember. If it is near the time of the next dose, skip the||
5138|173|D|missed dose. Take your next dose at the regular time. Do not||
5138|174|D|double the dose to catch up.||
5138|175|B|||
5138|176|R|STORAGE:  Store at room temperature away from light and moisture.||
5138|177|R|Do not store in the bathroom. Keep all medications away from||
5138|178|R|children and pets.||
5138|179|R|   Do not flush medications down the toilet or pour them into a||
5138|180|R|drain unless instructed to do so. Properly discard this product||
5138|181|R|when it is expired or no longer needed. Consult your pharmacist||
5138|182|R|or local waste disposal company.||
5138|183|B|||
5138|184|A|Information last revised April 2025.||
5138|185|A|Copyright(c) 2025 First Databank, Inc.||
5138|186|B|||
5143|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5143|002|Z|does NOT have all possible information about this product. This||
5143|003|Z|information does not assure that this product is safe, effective,||
5143|004|Z|or appropriate for you. This information is not individual||
5143|005|Z|medical advice and does not substitute for the advice of your||
5143|006|Z|health care professional. Always ask your health care||
5143|007|Z|professional for complete information about this product and your||
5143|008|Z|specific health needs.||
5143|009|B|||
5143|010|T|PANTOPRAZOLE DELAYED-RELEASE - ORAL||
5143|011|F|(pan-TOE-pruh-zole)||
5143|012|B|||
5143|013|C|COMMON BRAND NAME(S): Protonix||
5143|014|B|||
5143|015|U|USES:  Pantoprazole is used to treat certain stomach and||
5143|016|U|esophagus problems (such as acid reflux). It works by decreasing||
5143|017|U|the amount of acid your stomach makes. This medication relieves||
5143|018|U|symptoms such as heartburn, difficulty swallowing, and cough. It||
5143|019|U|helps heal acid damage to the stomach and esophagus, helps||
5143|020|U|prevent ulcers, and may help prevent cancer of the esophagus.||
5143|021|U|Pantoprazole belongs to a class of drugs known as proton pump||
5143|022|U|inhibitors (PPIs).||
5143|023|B|||
5143|024|V|OTHER USES:  This section contains uses of this drug that are not||
5143|025|V|listed in the approved US professional labeling for the drug but||
5143|026|V|that may be prescribed by your health care professional. Use this||
5143|027|V|drug for a condition that is listed in this section only if it||
5143|028|V|has been so prescribed by your health care professional.||
5143|029|V|   This drug may also be used for stomach and intestinal ulcers.||
5143|030|B|||
5143|031|H|HOW TO USE:  Read the Medication Guide provided by your||
5143|032|H|pharmacist before you start taking pantoprazole and each time you||
5143|033|H|get a refill. If you have any questions, ask your doctor or||
5143|034|H|pharmacist.||
5143|035|H|   Take this medication by mouth as directed by your doctor,||
5143|036|H|usually once daily. The dosage and length of treatment are based||
5143|037|H|on your medical condition and response to treatment. Children's||
5143|038|H|dosage is also based on weight.||
5143|039|H|   If you are taking the tablets, you may take them with or||
5143|040|H|without food. Swallow the tablets whole. Do not split, crush, or||
5143|041|H|chew the medication. Doing so may destroy the drug.||
5143|042|H|   If you are taking the granules, take your dose 30 minutes||
5143|043|H|before a meal. To take it by mouth, open the packet and mix the||
5143|044|H|granules in applesauce or apple juice. Do not mix with other||
5143|045|H|foods or liquids. Do not crush or chew the granules. Sprinkle the||
5143|046|H|granules on 1 teaspoon (5 milliliters) of applesauce and swallow||
5143|047|H|all of the mixture right away (within 10 minutes). Follow with||
5143|048|H|sips of water. Or you can mix the granules with 1 teaspoon (5||
5143|049|H|milliliters) of apple juice in a small cup, stir for 5 seconds,||
5143|050|H|and swallow all of the mixture right away. To make sure you take||
5143|051|H|the entire dose, rinse the cup once or twice with apple juice to||
5143|052|H|mix any remaining granules, and swallow the juice. Do not prepare||
5143|053|H|the mixture ahead of time for later use.||
5143|054|H|   If you are giving the granules through a tube into the stomach||
5143|055|H|(nasogastric or gastric tube), ask your health care professional||
5143|056|H|for detailed instructions on how to properly mix and give it.||
5143|057|H|   If needed, antacids may be taken along with this medication.||
5143|058|H|If you are also taking sucralfate, take pantoprazole at least 30||
5143|059|H|minutes before sucralfate.||
5143|060|H|   Use this medication regularly to get the most benefit from it.||
5143|061|H|To help you remember, take it at the same time each day. Continue||
5143|062|H|to take this medication for the prescribed length of treatment||
5143|063|H|even if you are feeling better.||
5143|064|H|   Tell your doctor if your condition lasts or gets worse. The||
5143|065|H|risk of side effects goes up over time. Ask your doctor how long||
5143|066|H|you should take this medication.||
5143|067|B|||
5143|068|S|SIDE EFFECTS:  Headache or diarrhea may occur. If any of these||
5143|069|S|effects last or get worse, tell your doctor or pharmacist||
5143|070|S|promptly.||
5143|071|S|   Remember that this medication has been prescribed because your||
5143|072|S|doctor has judged that the benefit to you is greater than the||
5143|073|S|risk of side effects. Many people using this medication do not||
5143|074|S|have serious side effects.||
5143|075|S|   Tell your doctor right away if you have any serious side||
5143|076|S|effects, including: symptoms of a low magnesium blood level (such||
5143|077|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
5143|078|S|(such as rash on nose and cheeks, new or worsening joint pain),||
5143|079|S|signs of kidney problems (such as change in the amount of urine,||
5143|080|S|pink/bloody urine).||
5143|081|S|   This medication may rarely cause a severe intestinal condition||
5143|082|S|due to a bacteria called C. difficile. This condition may occur||
5143|083|S|during treatment or weeks to months after treatment has stopped.||
5143|084|S|Tell your doctor right away if you develop: diarrhea that doesn't||
5143|085|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
5143|086|S|stool.||
5143|087|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
5143|088|S|products because they may make symptoms worse.||
5143|089|S|   Rarely, proton pump inhibitors (such as pantoprazole) have||
5143|090|S|caused vitamin B-12 deficiency. The risk is increased if they are||
5143|091|S|taken every day for a long time (3 years or longer). Tell your||
5143|092|S|doctor right away if you develop symptoms of vitamin B-12||
5143|093|S|deficiency (such as unusual weakness, sore tongue, or||
5143|094|S|numbness/tingling of the hands/feet).||
5143|095|S|   A very serious allergic reaction to this drug is rare.||
5143|096|S|However, get medical help right away if you notice any symptoms||
5143|097|S|of a serious allergic reaction, including: fever, swollen lymph||
5143|098|S|nodes, rash, itching/swelling (especially of the||
5143|099|S|face/tongue/throat), severe dizziness, trouble breathing.||
5143|100|S|   This is not a complete list of possible side effects. If you||
5143|101|S|notice other effects not listed above, contact your doctor or||
5143|102|S|pharmacist.||
5143|103|S|   In the US -||
5143|104|S|   Call your doctor for medical advice about side effects. You||
5143|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5143|106|S|www.fda.gov/medwatch.||
5143|107|S|   In Canada - Call your doctor for medical advice about side||
5143|108|S|effects. You may report side effects to Health Canada at||
5143|109|S|1-866-234-2345.||
5143|110|B|||
5143|111|P|PRECAUTIONS:  Before taking pantoprazole, tell your doctor or||
5143|112|P|pharmacist if you are allergic to it; or to similar drugs (such||
5143|113|P|as lansoprazole, omeprazole); or if you have any other allergies.||
5143|114|P|This product may contain inactive ingredients, which can cause||
5143|115|P|allergic reactions or other problems. Talk to your pharmacist for||
5143|116|P|more details.||
5143|117|P|   Before using this medication, tell your doctor or pharmacist||
5143|118|P|your medical history, especially of: liver disease, lupus.||
5143|119|P|   Some symptoms may actually be signs of a more serious||
5143|120|P|condition. Get medical help right away if you have: heartburn||
5143|121|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
5143|122|P|pain (especially with shortness of breath, unusual sweating),||
5143|123|P|unexplained weight loss.||
5143|124|P|   Before having surgery, tell your doctor or dentist about all||
5143|125|P|the products you use (including prescription drugs,||
5143|126|P|nonprescription drugs, and herbal products).||
5143|127|P|   Proton pump inhibitors (such as pantoprazole) may increase||
5143|128|P|your risk for bone fractures, especially with longer use, higher||
5143|129|P|doses, and in older adults. Talk with your doctor or pharmacist||
5143|130|P|about ways to prevent bone loss/fracture, such as by taking||
5143|131|P|calcium (such as calcium citrate) and vitamin D supplements.||
5143|132|P|   Older adults may be more sensitive to the side effects of this||
5143|133|P|drug, especially bone loss and fractures (see above), and C.||
5143|134|P|difficile infection (see Side Effects section).||
5143|135|P|   During pregnancy, this medication should be used only when||
5143|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
5143|137|P|   This medication passes into breast milk. Consult your doctor||
5143|138|P|before breastfeeding.||
5143|139|B|||
5143|140|I|DRUG INTERACTIONS:  See also How to Use section.||
5143|141|I|   Drug interactions may change how your medications work or||
5143|142|I|increase your risk for serious side effects. This document does||
5143|143|I|not contain all possible drug interactions. Keep a list of all||
5143|144|I|the products you use (including prescription/nonprescription||
5143|145|I|drugs and herbal products) and share it with your doctor and||
5143|146|I|pharmacist. Do not start, stop, or change the dosage of any||
5143|147|I|medicines without your doctor's approval.||
5143|148|I|   A product that may interact with this drug is: methotrexate||
5143|149|I|(especially high-dose treatment).||
5143|150|I|   Some products need stomach acid so that the body can absorb||
5143|151|I|them properly. Pantoprazole decreases stomach acid, so it may||
5143|152|I|change how well these products work. Some affected products||
5143|153|I|include ampicillin, atazanavir, erlotinib, levoketoconazole,||
5143|154|I|nelfinavir, pazopanib, rilpivirine, sparsentan, certain azole||
5143|155|I|antifungals (itraconazole, ketoconazole, posaconazole), among||
5143|156|I|others.||
5143|157|I|   This medication may interfere with certain lab tests (such as||
5143|158|I|urine test for tetrahydrocannabinol-THC, blood test to find||
5143|159|I|certain tumors), possibly causing false test results. Make sure||
5143|160|I|lab personnel and all your doctors know you use this drug.||
5143|161|B|||
5143|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5143|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5143|164|O|poison control center right away. US residents can call||
5143|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5143|166|B|||
5143|167|N|NOTES:  Do not share this medication with others.||
5143|168|N|   If your doctor instructs you to use this medication regularly||
5143|169|N|for a long time, lab and/or medical tests (such as a magnesium||
5143|170|N|blood test, vitamin B-12 levels) may be done while you are taking||
5143|171|N|this medication. Keep all medical and lab appointments. Consult||
5143|172|N|your doctor for more details.||
5143|173|B|||
5143|174|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5143|175|D|remember. If it is near the time of the next dose, skip the||
5143|176|D|missed dose. Take your next dose at the regular time. Do not||
5143|177|D|double the dose to catch up.||
5143|178|B|||
5143|179|R|STORAGE:  Store at room temperature away from light and moisture.||
5143|180|R|Do not store in the bathroom. Keep all medications away from||
5143|181|R|children and pets.||
5143|182|R|   Do not flush medications down the toilet or pour them into a||
5143|183|R|drain unless instructed to do so. Properly discard this product||
5143|184|R|when it is expired or no longer needed. Consult your pharmacist||
5143|185|R|or local waste disposal company.||
5143|186|B|||
5143|187|A|Information last revised August 2024.||
5143|188|A|Copyright(c) 2025 First Databank, Inc.||
5143|189|B|||
5146|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5146|002|Z|does NOT have all possible information about this product. This||
5146|003|Z|information does not assure that this product is safe, effective,||
5146|004|Z|or appropriate for you. This information is not individual||
5146|005|Z|medical advice and does not substitute for the advice of your||
5146|006|Z|health care professional. Always ask your health care||
5146|007|Z|professional for complete information about this product and your||
5146|008|Z|specific health needs.||
5146|009|B|||
5146|010|T|INFLIXIMAB - INJECTION||
5146|011|F|(in-FLIX-i-mab)||
5146|012|B|||
5146|013|C|COMMON BRAND NAME(S): Avsola, Inflectra, Remicade, Renflexis||
5146|014|B|||
5146|015|W|WARNING:  This medication can decrease your body's ability to||
5146|016|W|fight an infection. This effect can lead to very serious||
5146|017|W|(possibly fatal) infections (such as fungal infections, bacterial||
5146|018|W|infections including tuberculosis). You should have a||
5146|019|W|tuberculosis (TB) skin test before and during treatment with this||
5146|020|W|medication. Also tell your doctor your medical history,||
5146|021|W|especially of past/recent/current infections. You should also||
5146|022|W|tell your doctor if you have lived or traveled in areas where||
5146|023|W|certain fungal infections (such as coccidioidomycosis,||
5146|024|W|histoplasmosis) are common or if you have been near someone with||
5146|025|W|tuberculosis. Areas where these types of fungal infections are||
5146|026|W|commonly found include the Ohio and Mississippi River valleys and||
5146|027|W|the southwestern United States. See Side Effects section for||
5146|028|W|symptoms of infections to watch out for, and get medical help||
5146|029|W|right away if you have any of these symptoms.||
5146|030|W|   The immune system also helps prevent and control cancer. There||
5146|031|W|is a very small risk (especially in children/teens/young adults)||
5146|032|W|of developing cancer (such as lymphoma, skin cancer) due to this||
5146|033|W|medication or due to your medical condition. A rare, mostly fatal||
5146|034|W|cancer (hepatosplenic T-cell lymphoma) has occurred in people||
5146|035|W|receiving this medication along with certain other drugs||
5146|036|W|(azathioprine or 6-mercaptopurine) to treat Crohn's disease or||
5146|037|W|ulcerative colitis. Talk to your doctor about the risks and||
5146|038|W|benefits of treatment. Tell your doctor right away if you have||
5146|039|W|symptoms such as unusual lumps/growths, swollen lymph nodes,||
5146|040|W|swollen or painful abdomen, unexplained weight loss, fever that||
5146|041|W|doesn't go away, or night sweats.||
5146|042|B|||
5146|043|U|USES:  This medication is used to treat certain types of||
5146|044|U|arthritis (rheumatoid arthritis, arthritis of the spine,||
5146|045|U|psoriatic arthritis), certain bowel diseases (Crohn's disease,||
5146|046|U|ulcerative colitis), and a certain severe skin disease (chronic||
5146|047|U|plaque psoriasis). In these conditions, the body's defense system||
5146|048|U|(immune system) attacks healthy tissues. Infliximab works by||
5146|049|U|blocking the actions of a certain natural substance (tumor||
5146|050|U|necrosis factor alpha) in the body. This helps to decrease||
5146|051|U|swelling (inflammation) and weaken your immune system, which||
5146|052|U|slows or stops the damage from the disease.||
5146|053|U|   This monograph is about the following infliximab products:||
5146|054|U|infliximab, infliximab-abda, infliximab-axxq, and||
5146|055|U|infliximab-dyyb.||
5146|056|B|||
5146|057|H|HOW TO USE:  Read the Medication Guide provided by your||
5146|058|H|pharmacist before you start using infliximab and each time you||
5146|059|H|get a refill. If you have any questions, ask your doctor or||
5146|060|H|pharmacist.||
5146|061|H|   This medication is given by injection into a vein over at||
5146|062|H|least 2 hours as directed by your doctor. The dosage is based on||
5146|063|H|your medical condition, weight, and response to treatment. After||
5146|064|H|the first dose, this medication is usually given again after 2||
5146|065|H|weeks and 6 weeks, then every 8 weeks (or every 6 weeks for||
5146|066|H|arthritis of the spine), as directed by your doctor.||
5146|067|H|   Infusion reactions may happen during the infusion of this||
5146|068|H|drug. Your doctor may prescribe other medications before each||
5146|069|H|treatment to help prevent these side effects. Tell your doctor||
5146|070|H|right away if you have any symptoms of infusion reactions such as||
5146|071|H|pain/swelling at the injection site, shortness of breath,||
5146|072|H|flushing, chills, fever, or headache. Your doctor may give you||
5146|073|H|other medications to help with these side effects or may slow||
5146|074|H|down or stop your treatment for some time.||
5146|075|H|   If you are using this medication at home, learn all||
5146|076|H|preparation and usage instructions from your health care||
5146|077|H|professional. Do not shake this medication. Before using, check||
5146|078|H|this product for particles or discoloration. If either is||
5146|079|H|present, do not use the liquid. Learn how to store and discard||
5146|080|H|medical supplies safely.||
5146|081|H|   Use this medication regularly to get the most benefit from it.||
5146|082|H|To help you remember, mark your calendar with a reminder.||
5146|083|H|   Tell your doctor if your condition lasts or gets worse.||
5146|084|B|||
5146|085|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
5146|086|S|   Headache, stomach pain, or nausea may occur. If any of these||
5146|087|S|effects last or get worse, tell your doctor or pharmacist||
5146|088|S|promptly.||
5146|089|S|   Remember that this medication has been prescribed because your||
5146|090|S|doctor has judged that the benefit to you is greater than the||
5146|091|S|risk of side effects. Many people using this medication do not||
5146|092|S|have serious side effects.||
5146|093|S|   Tell your doctor right away if you have any serious side||
5146|094|S|effects, including: joint/muscle pain, easy bruising/bleeding,||
5146|095|S|seizures, confusion, muscle weakness, numbness/tingling of||
5146|096|S|arms/legs, butterfly-shaped facial rash, pain/redness/swelling of||
5146|097|S|arms or legs, new or worsening symptoms of heart failure (such as||
5146|098|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
5146|099|S|unusual/sudden weight gain).||
5146|100|S|   Tell your doctor right away if you develop signs of infection||
5146|101|S|while using this drug, such as: cough/sore throat that doesn't go||
5146|102|S|away, fever, chills, night sweats, painful/frequent urination,||
5146|103|S|unusual vaginal discharge, white patches in the mouth (oral||
5146|104|S|thrush).||
5146|105|S|   This drug may rarely cause serious (possibly fatal) liver||
5146|106|S|disease. Get medical help right away if you have any symptoms of||
5146|107|S|liver damage, such as: unusual tiredness, nausea/vomiting that||
5146|108|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
5146|109|S|eyes/skin, dark urine.||
5146|110|S|   Heart problems (such as heart attack) may happen during the||
5146|111|S|infusion of this drug and for up to 24 hours afterward. Get||
5146|112|S|medical help right away if you have any symptoms of heart||
5146|113|S|problems such as chest/jaw/left arm pain, shortness of breath,||
5146|114|S|unusual sweating, lightheadedness, dizziness, fainting, vision||
5146|115|S|changes, or fast/irregular/slow heartbeat.||
5146|116|S|   A very serious allergic reaction to this drug is rare.||
5146|117|S|However, get medical help right away if you notice any symptoms||
5146|118|S|of a serious allergic reaction, including: rash, itching/swelling||
5146|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5146|120|S|breathing, difficulty swallowing.||
5146|121|S|   This is not a complete list of possible side effects. If you||
5146|122|S|notice other effects not listed above, contact your doctor or||
5146|123|S|pharmacist.||
5146|124|S|   In the US -||
5146|125|S|   Call your doctor for medical advice about side effects. You||
5146|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5146|127|S|www.fda.gov/medwatch.||
5146|128|S|   In Canada - Call your doctor for medical advice about side||
5146|129|S|effects. You may report side effects to Health Canada at||
5146|130|S|1-866-234-2345.||
5146|131|B|||
5146|132|P|PRECAUTIONS:  Before using infliximab, tell your doctor or||
5146|133|P|pharmacist if you are allergic to it; or to other infliximab||
5146|134|P|products; or if you have any other allergies. This product may||
5146|135|P|contain inactive ingredients, which can cause allergic reactions||
5146|136|P|or other problems. Talk to your pharmacist for more details.||
5146|137|P|   Before using this medication, tell your doctor or pharmacist||
5146|138|P|your medical history, especially of: tuberculosis (previous||
5146|139|P|infection or positive skin test), past/recent/current infections||
5146|140|P|(such as cold sores, valley fever), heart disease (such as heart||
5146|141|P|failure), blood/bone marrow disorder (such as leukopenia,||
5146|142|P|thrombocytopenia), nervous system disorder (such as||
5146|143|P|numbness/tingling, seizures, multiple sclerosis), cancer (such as||
5146|144|P|breast cancer, skin cancer, lymphoma), a certain lung disorder||
5146|145|P|(chronic obstructive pulmonary disease-COPD), liver disease (such||
5146|146|P|as hepatitis B), light treatment for psoriasis (phototherapy).||
5146|147|P|   Before having surgery, tell your doctor or dentist about all||
5146|148|P|the products you use (including prescription drugs,||
5146|149|P|nonprescription drugs, and herbal products).||
5146|150|P|   Infliximab can make you more likely to get infections or may||
5146|151|P|make current infections worse. Stay away from anyone who has an||
5146|152|P|infection that may easily spread (such as chickenpox, COVID-19,||
5146|153|P|measles, flu). Talk to your doctor if you have been exposed to an||
5146|154|P|infection or for more details.||
5146|155|P|   Tell your health care professional that you are using||
5146|156|P|infliximab before having any immunizations/vaccinations. Avoid||
5146|157|P|contact with people who have recently received live vaccines||
5146|158|P|(such as flu vaccine inhaled through the nose).||
5146|159|P|   Older adults may be more sensitive to the side effects of this||
5146|160|P|drug, especially risk for infections.||
5146|161|P|   During pregnancy, this medication should be used only when||
5146|162|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
5146|163|P|benefits with your doctor. Mothers who have used this medication||
5146|164|P|during pregnancy should ask a doctor about||
5146|165|P|immunizations/vaccinations for their newborn babies.||
5146|166|P|   This drug may pass into breast milk, but it is unlikely to||
5146|167|P|harm a nursing infant. Consult your doctor before breastfeeding.||
5146|168|B|||
5146|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5146|170|I|medications work or increase your risk for serious side effects.||
5146|171|I|This document does not contain all possible drug interactions.||
5146|172|I|Keep a list of all the products you use (including||
5146|173|I|prescription/nonprescription drugs and herbal products) and share||
5146|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
5146|175|I|the dosage of any medicines without your doctor's approval.||
5146|176|I|   Some products that may interact with this drug are: other||
5146|177|I|drugs that weaken the immune system/increase the risk of||
5146|178|I|infection (such as abatacept, anakinra), treatment with weakened||
5146|179|I|bacteria/viruses (such as live vaccines, BCG for bladder cancer).||
5146|180|B|||
5146|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5146|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5146|183|O|poison control center right away. US residents can call||
5146|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5146|185|B|||
5146|186|N|NOTES:  Do not share this medication with others.||
5146|187|N|   Lab and/or medical tests (such as complete blood count, liver||
5146|188|N|function, skin exams, Pap smear) should be done while you are||
5146|189|N|using this medication. Keep all medical and lab appointments.||
5146|190|N|Consult your doctor for more details.||
5146|191|B|||
5146|192|D|MISSED DOSE:  It is important to get each dose of this medication||
5146|193|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
5146|194|D|right away for a new dosing schedule. Do not double the dose to||
5146|195|D|catch up.||
5146|196|B|||
5146|197|R|STORAGE:  Consult the product instructions and your pharmacist||
5146|198|R|for storage details. Keep all medications away from children and||
5146|199|R|pets.||
5146|200|R|   Do not flush medications down the toilet or pour them into a||
5146|201|R|drain unless instructed to do so. Properly discard this product||
5146|202|R|when it is expired or no longer needed. Consult your pharmacist||
5146|203|R|or local waste disposal company.||
5146|204|B|||
5146|205|M|MEDICAL ALERT:  Your condition can cause complications in a||
5146|206|M|medical emergency. For information about enrolling in MedicAlert,||
5146|207|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5146|208|B|||
5146|209|A|Information last revised May 2025.||
5146|210|A|Copyright(c) 2025 First Databank, Inc.||
5146|211|B|||
5154|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5154|002|Z|does NOT have all possible information about this product. This||
5154|003|Z|information does not assure that this product is safe, effective,||
5154|004|Z|or appropriate for you. This information is not individual||
5154|005|Z|medical advice and does not substitute for the advice of your||
5154|006|Z|health care professional. Always ask your health care||
5154|007|Z|professional for complete information about this product and your||
5154|008|Z|specific health needs.||
5154|009|B|||
5154|010|T|LINEZOLID SUSPENSION - ORAL||
5154|011|F|(lin-AYZ-oh-lid)||
5154|012|B|||
5154|013|C|COMMON BRAND NAME(S): Zyvox||
5154|014|B|||
5154|015|U|USES:  Linezolid is an antibiotic used to treat certain serious||
5154|016|U|bacterial infections. It works by stopping the growth of||
5154|017|U|bacteria.||
5154|018|U|   This antibiotic treats only bacterial infections. It will not||
5154|019|U|work for viral infections (such as common cold, flu). Using any||
5154|020|U|antibiotic when it is not needed can cause it to not work for||
5154|021|U|future infections.||
5154|022|U|   Linezolid also belongs to a class of drugs known as MAO||
5154|023|U|inhibitors. It can increase the levels of certain natural||
5154|024|U|substances in the body (such as dopamine, norepinephrine,||
5154|025|U|serotonin) which can increase the chance of certain side effects||
5154|026|U|and food and drug interactions. See How to Use, Side Effects, and||
5154|027|U|Drug Interactions sections for more details.||
5154|028|B|||
5154|029|H|HOW TO USE:  Take this medication by mouth with or without food||
5154|030|H|as directed by your doctor, usually every 12 hours. The dosage is||
5154|031|H|based on your medical condition and response to treatment.||
5154|032|H|Children's dosage is also based on age and weight, and they may||
5154|033|H|be directed to take this medication every 8 hours.||
5154|034|H|   Before taking each dose, mix the suspension by gently turning||
5154|035|H|the bottle upside down 3 to 5 times. Do not shake this||
5154|036|H|medication. Carefully measure the dose using a special measuring||
5154|037|H|device/spoon. Do not use a household spoon because you may not||
5154|038|H|get the correct dose.||
5154|039|H|   To prevent a very serious high blood pressure reaction, it is||
5154|040|H|very important that you follow a special diet recommended by your||
5154|041|H|doctor or dietician to limit your intake of tyramine while you||
5154|042|H|are taking this medicine. Avoid foods and beverages that are high||
5154|043|H|in tyramine, including aged cheeses, dried/aged meats and||
5154|044|H|sausages (such as salami, liverwurst), preserved fish (such as||
5154|045|H|pickled herring), products that contain large amounts of yeast||
5154|046|H|(such as bouillon cubes, powdered soup/gravy, homemade or||
5154|047|H|sourdough bread), fermented foods (such as sauerkraut, kim chee),||
5154|048|H|most soybean products (such as soy sauce, tofu), broad/fava||
5154|049|H|beans, red wine, sherry, tap beers, and vermouth. Consult your||
5154|050|H|doctor or dietician for more details and a complete list of other||
5154|051|H|foods that contain tyramine which you should limit or avoid.||
5154|052|H|   For the best effect, take this antibiotic at evenly spaced||
5154|053|H|times. To help you remember, take this medication at the same||
5154|054|H|time(s) every day.||
5154|055|H|   Continue to take this medication until the full prescribed||
5154|056|H|amount is finished, even if symptoms disappear after a few days.||
5154|057|H|Stopping the medication too early may result in a return of the||
5154|058|H|infection.||
5154|059|H|   Tell your doctor if your condition lasts or gets worse.||
5154|060|B|||
5154|061|S|SIDE EFFECTS:  Diarrhea, headache, nausea, vomiting, or dizziness||
5154|062|S|may occur. If any of these effects last or get worse, tell your||
5154|063|S|doctor or pharmacist promptly.||
5154|064|S|   Remember that this medication has been prescribed because your||
5154|065|S|doctor has judged that the benefit to you is greater than the||
5154|066|S|risk of side effects. Many people using this medication do not||
5154|067|S|have serious side effects.||
5154|068|S|   Tell your doctor right away if you have any serious side||
5154|069|S|effects, including: deep/fast breathing, unusual drowsiness,||
5154|070|S|nausea/vomiting that doesn't stop, numbness/tingling of the||
5154|071|S|hands/feet, unusual tiredness, easy bruising/bleeding, muscle||
5154|072|S|pain/tenderness/weakness.||
5154|073|S|   Get medical help right away if you have any very serious side||
5154|074|S|effects, including: muscle stiffness, increased sweating, vision||
5154|075|S|changes (such as blurred vision, change in color vision, loss of||
5154|076|S|vision), mental/mood changes (such as agitation, confusion),||
5154|077|S|seizure.||
5154|078|S|   This medication may rarely cause a severe intestinal condition||
5154|079|S|due to a bacteria called C. difficile. This condition may occur||
5154|080|S|during treatment or weeks to months after treatment has stopped.||
5154|081|S|Tell your doctor right away if you develop: diarrhea that doesn't||
5154|082|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
5154|083|S|stool.||
5154|084|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
5154|085|S|products because they may make symptoms worse.||
5154|086|S|   Use of this medication for prolonged or repeated periods may||
5154|087|S|result in oral thrush or a new yeast infection. Contact your||
5154|088|S|doctor if you notice white patches in your mouth, a change in||
5154|089|S|vaginal discharge, or other new symptoms.||
5154|090|S|   This medication may increase serotonin and rarely cause a very||
5154|091|S|serious condition called serotonin syndrome/toxicity. The risk||
5154|092|S|increases if you are also taking other drugs that increase||
5154|093|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
5154|094|S|take. Get medical help right away if you develop some of the||
5154|095|S|following symptoms: fast heartbeat, hallucinations, loss of||
5154|096|S|coordination, severe dizziness, severe nausea/vomiting/diarrhea,||
5154|097|S|twitching muscles, unexplained fever, unusual||
5154|098|S|agitation/restlessness.||
5154|099|S|   This drug may rarely cause an attack of extremely high blood||
5154|100|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
5154|101|S|food interactions can increase this risk (see How to Use and Drug||
5154|102|S|Interactions sections). Get medical help right away if any of||
5154|103|S|these serious side effects occur: severe headache,||
5154|104|S|fast/slow/irregular/pounding heartbeat, chest pain, neck||
5154|105|S|stiffness/soreness, severe nausea/vomiting, sweating/clammy skin||
5154|106|S|(sometimes with fever), widened pupils, vision changes (such as||
5154|107|S|double/blurred vision), sudden sensitivity to light||
5154|108|S|(photophobia).||
5154|109|S|   A very serious allergic reaction to this drug is rare.||
5154|110|S|However, get medical help right away if you notice any symptoms||
5154|111|S|of a serious allergic reaction, including: rash, itching/swelling||
5154|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5154|113|S|breathing.||
5154|114|S|   This is not a complete list of possible side effects. If you||
5154|115|S|notice other effects not listed above, contact your doctor or||
5154|116|S|pharmacist.||
5154|117|S|   In the US -||
5154|118|S|   Call your doctor for medical advice about side effects. You||
5154|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5154|120|S|www.fda.gov/medwatch.||
5154|121|S|   In Canada - Call your doctor for medical advice about side||
5154|122|S|effects. You may report side effects to Health Canada at||
5154|123|S|1-866-234-2345.||
5154|124|B|||
5154|125|P|PRECAUTIONS:  Before taking linezolid, tell your doctor or||
5154|126|P|pharmacist if you are allergic to it; or if you have any other||
5154|127|P|allergies. This product may contain inactive ingredients, which||
5154|128|P|can cause allergic reactions or other problems. Talk to your||
5154|129|P|pharmacist for more details.||
5154|130|P|   Before using this medication, tell your doctor or pharmacist||
5154|131|P|your medical history, especially of: high blood pressure,||
5154|132|P|blood/bone marrow problems (such as low red/white blood cells and||
5154|133|P|platelets), kidney problems, liver problems, certain tumor||
5154|134|P|conditions (such as pheochromocytoma, carcinoid syndrome),||
5154|135|P|overactive thyroid, seizures.||
5154|136|P|   This medication may contain aspartame. If you have||
5154|137|P|phenylketonuria (PKU) or any other condition that requires you to||
5154|138|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
5154|139|P|doctor or pharmacist about using this medication safely.||
5154|140|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5154|141|P|can make you more dizzy. Do not drive, use machinery, or do||
5154|142|P|anything that needs alertness until you can do it safely. Limit||
5154|143|P|alcoholic beverages. Talk to your doctor if you are using||
5154|144|P|marijuana (cannabis).||
5154|145|P|   If you have diabetes, linezolid may lower your blood sugar.||
5154|146|P|Check your blood sugar regularly as directed and share the||
5154|147|P|results with your doctor. Tell your doctor right away if you have||
5154|148|P|symptoms of low blood sugar such as sudden sweating, shaking,||
5154|149|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
5154|150|P|hands/feet. Your doctor may need to adjust your diabetes||
5154|151|P|medication, exercise program, or diet.||
5154|152|P|   Linezolid may cause live bacterial vaccines (such as typhoid||
5154|153|P|vaccine) to not work well. Tell your health care professional||
5154|154|P|that you are using linezolid before having any||
5154|155|P|immunizations/vaccinations.||
5154|156|P|   Before having surgery, tell your doctor or dentist about all||
5154|157|P|the products you use (including prescription drugs,||
5154|158|P|nonprescription drugs, and herbal products).||
5154|159|P|   During pregnancy, this medication should be used only when||
5154|160|P|clearly needed. Discuss the risks and benefits with your doctor.||
5154|161|P|   This medication passes into breast milk and may have||
5154|162|P|undesirable effects on a nursing infant. Consult your doctor||
5154|163|P|before breastfeeding.||
5154|164|B|||
5154|165|I|DRUG INTERACTIONS:  See also How to Use section.||
5154|166|I|   Drug interactions may change how your medications work or||
5154|167|I|increase your risk for serious side effects. This document does||
5154|168|I|not contain all possible drug interactions. Keep a list of all||
5154|169|I|the products you use (including prescription/nonprescription||
5154|170|I|drugs and herbal products) and share it with your doctor and||
5154|171|I|pharmacist. Do not start, stop, or change the dosage of any||
5154|172|I|medicines without your doctor's approval.||
5154|173|I|   Some products that may interact with this drug include: diet||
5154|174|I|pills/appetite suppressants (such as diethylpropion), drugs for||
5154|175|I|attention deficit disorder (such as atomoxetine,||
5154|176|I|methylphenidate), apraclonidine, bupropion, buspirone,||
5154|177|I|carbamazepine, cyclobenzaprine, deutetrabenazine, a certain||
5154|178|I|combination product (dextromethorphan/quinidine), maprotiline,||
5154|179|I|methyldopa, metoclopramide, certain opioid pain relievers (such||
5154|180|I|as fentanyl, meperidine, methadone, tapentadol), certain drugs||
5154|181|I|for Parkinson's disease (such as entacapone, levodopa,||
5154|182|I|tolcapone), certain supplements (such as tryptophan, tyramine),||
5154|183|I|tetrabenazine, tricyclic antidepressants (such as amitriptyline,||
5154|184|I|doxepin), valbenazine.||
5154|185|I|   The risk of serotonin syndrome/toxicity increases if you are||
5154|186|I|also taking other drugs that increase serotonin. Examples include||
5154|187|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
5154|188|I|antidepressants (including mirtazapine, SSRIs such as||
5154|189|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
5154|190|I|tramadol, certain "triptans" used to treat migraine headaches||
5154|191|I|(such as rizatriptan, sumatriptan, zolmitriptan), among others.||
5154|192|I|The risk of serotonin syndrome/toxicity may be more likely when||
5154|193|I|you start or increase the dose of these drugs.||
5154|194|I|   Some products can interact with linezolid if you take them||
5154|195|I|together, or even if you take them weeks before or after taking||
5154|196|I|linezolid. Tell your doctor or pharmacist if you take anything in||
5154|197|I|the list of products that may interact with this drug, or any of||
5154|198|I|the products that increase serotonin, within 2 weeks before or||
5154|199|I|after taking linezolid. Also tell them if you have taken||
5154|200|I|fluoxetine within 5 weeks before starting linezolid. Ask your||
5154|201|I|doctor how much time to wait between starting or stopping any of||
5154|202|I|these drugs and starting linezolid.||
5154|203|I|   Taking other MAO inhibitors with this medication may cause a||
5154|204|I|serious (possibly fatal) drug interaction. Do not take any other||
5154|205|I|MAO inhibitors (isocarboxazid, metaxalone, methylene blue,||
5154|206|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
5154|207|I|selegiline, tranylcypromine) during treatment with this||
5154|208|I|medication. Most MAO inhibitors should also not be taken for two||
5154|209|I|weeks before and after treatment with this medication. Ask your||
5154|210|I|doctor when to start or stop taking this medication.||
5154|211|I|   Before using linezolid, report the use of drugs that may||
5154|212|I|increase the risk of extremely high blood pressure (hypertensive||
5154|213|I|crisis) when combined with linezolid, including herbal products||
5154|214|I|(such as ephedra/ma huang), allergy and cold products (including||
5154|215|I|decongestants such as phenylephrine/pseudoephedrine), and||
5154|216|I|stimulants (such as amphetamines, ephedrine, epinephrine).||
5154|217|I|Linezolid should not be used with any of these medications. Talk||
5154|218|I|to your doctor or pharmacist for more details.||
5154|219|B|||
5154|220|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5154|221|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5154|222|O|poison control center right away. US residents can call||
5154|223|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5154|224|B|||
5154|225|N|NOTES:  Do not share this medication with others.||
5154|226|N|   This medication has been prescribed for your current condition||
5154|227|N|only. Do not use it later for another infection unless your||
5154|228|N|doctor tells you to.||
5154|229|N|   Lab and/or medical tests (such as complete blood count, blood||
5154|230|N|sodium levels) may be done while you are taking this medication.||
5154|231|N|Eye tests should also be done if you take linezolid for 3 months||
5154|232|N|or more, or if you have vision changes. Keep all medical and lab||
5154|233|N|appointments.||
5154|234|B|||
5154|235|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5154|236|D|remember. If it is near the time of the next dose, skip the||
5154|237|D|missed dose. Take your next dose at the regular time. Do not||
5154|238|D|double the dose to catch up.||
5154|239|B|||
5154|240|R|STORAGE:  Store the suspension at room temperature away from||
5154|241|R|light and moisture. Do not store in the bathroom. Discard any||
5154|242|R|unused portion after 21 days. Keep all medications away from||
5154|243|R|children and pets.||
5154|244|R|   Do not flush medications down the toilet or pour them into a||
5154|245|R|drain unless instructed to do so. Properly discard this product||
5154|246|R|when it is expired or no longer needed. Consult your pharmacist||
5154|247|R|or local waste disposal company.||
5154|248|B|||
5154|249|A|Information last revised August 2024.||
5154|250|A|Copyright(c) 2025 First Databank, Inc.||
5154|251|B|||
5157|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5157|002|Z|does NOT have all possible information about this product. This||
5157|003|Z|information does not assure that this product is safe, effective,||
5157|004|Z|or appropriate for you. This information is not individual||
5157|005|Z|medical advice and does not substitute for the advice of your||
5157|006|Z|health care professional. Always ask your health care||
5157|007|Z|professional for complete information about this product and your||
5157|008|Z|specific health needs.||
5157|009|B|||
5157|010|T|CMV IMMUNE GLOBULIN - INTRAVENOUS||
5157|011|F|(CMV ih-MYOON GLOB-you-lin)||
5157|012|B|||
5157|013|C|COMMON BRAND NAME(S): Cytogam||
5157|014|B|||
5157|015|W|WARNING:  This medication may rarely cause serious problems from||
5157|016|W|blood clots (such as heart attack, stroke, blood clots in the||
5157|017|W|lungs or legs). You may be at increased risk for blood clots if||
5157|018|W|you are an older adult, are severely dehydrated, have a catheter||
5157|019|W|in a vein close to your heart for giving medications, or have a||
5157|020|W|history of blood clots, heart/blood vessel disease, heart||
5157|021|W|failure, stroke, or if you are immobile (such as very long plane||
5157|022|W|flights or bedridden). If you use estrogen-containing products,||
5157|023|W|these may also increase your risk. Before using this medication,||
5157|024|W|discuss the risks and benefits and if you have any of these||
5157|025|W|conditions, report them to your doctor or pharmacist.||
5157|026|W|   The risk of blood clots may be decreased by infusing this||
5157|027|W|medication more slowly or by using a less concentrated form of||
5157|028|W|this medication if available. Being adequately hydrated before||
5157|029|W|receiving this medication may also help reduce this risk.||
5157|030|W|   Get medical help right away if any of these side effects||
5157|031|W|occur: shortness of breath/rapid breathing, chest/jaw/left arm||
5157|032|W|pain, unusual sweating, sudden dizziness/fainting,||
5157|033|W|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
5157|034|W|trouble speaking, weakness on one side of the body, sudden vision||
5157|035|W|changes, or confusion.||
5157|036|B|||
5157|037|U|USES:  This medication is used to prevent a certain serious viral||
5157|038|U|infection (cytomegalovirus-CMV) in persons having an organ||
5157|039|U|transplant (kidney, heart, liver, lung, pancreas). During the||
5157|040|U|transplant process, the body's defense system (immune system) is||
5157|041|U|weakened to prevent the body from attacking (rejecting) the new||
5157|042|U|organ. A weakened immune system increases the risk of a serious,||
5157|043|U|possibly fatal infection with CMV. This medication is made from||
5157|044|U|healthy human blood that has a high level of certain defensive||
5157|045|U|substances (antibodies) that help fight CMV. This medication is||
5157|046|U|often used with the antiviral medication ganciclovir.||
5157|047|B|||
5157|048|H|HOW TO USE:  This medication is given by slow infusion into a||
5157|049|H|vein. It is given as directed by your doctor, usually every 2 to||
5157|050|H|4 weeks, with the first dose given within 3 days of the||
5157|051|H|transplant. The dosage and frequency depends on your medical||
5157|052|H|condition, weight, and response to treatment.||
5157|053|H|   Your health care professional will start the medication slowly||
5157|054|H|while monitoring you closely. If you have few or no side effects,||
5157|055|H|the medication will be given faster. Tell your health care||
5157|056|H|professional right away if you experience any side effects such||
5157|057|H|as flushing, chills, muscle cramps, back/joint pain, fever,||
5157|058|H|nausea, vomiting, or shortness of breath. The infusion may need||
5157|059|H|to be stopped or given more slowly.||
5157|060|H|   If you are giving this medication to yourself at home, learn||
5157|061|H|all preparation and usage instructions from your health care||
5157|062|H|professional. Before using, check this product for particles or||
5157|063|H|discoloration. If either is present, do not use the liquid. Learn||
5157|064|H|how to store and discard medical supplies safely.||
5157|065|H|   Use this medication regularly in order to get the most benefit||
5157|066|H|from it. Keep all your medical/lab appointments.||
5157|067|B|||
5157|068|S|SIDE EFFECTS:  See also Warning section.||
5157|069|S|   Flushing, chills, muscle cramps, back/joint pain, fever,||
5157|070|S|nausea/vomiting may occur. Tell your doctor or health care||
5157|071|S|professional right away if any of these effects occur, last, or||
5157|072|S|get worse. Pain, redness, and swelling at the injection site may||
5157|073|S|also occur. If these effects continue or become bothersome, tell||
5157|074|S|your doctor.||
5157|075|S|   Remember that this medication has been prescribed because your||
5157|076|S|doctor has judged that the benefit to you is greater than the||
5157|077|S|risk of side effects. Many people using this medication do not||
5157|078|S|have serious side effects.||
5157|079|S|   Tell your doctor right away if you have any serious side||
5157|080|S|effects, including: easy bleeding/bruising, fast/irregular||
5157|081|S|heartbeat, unusual tiredness, signs of kidney problems (such as||
5157|082|S|change in the amount of urine, pink/bloody/frothy urine), sudden||
5157|083|S|weight gain.||
5157|084|S|   Treatment with this medication may rarely cause an||
5157|085|S|inflammation of the brain (aseptic meningitis syndrome) several||
5157|086|S|hours to 2 days after your treatment. Get medical help right away||
5157|087|S|if you develop severe headache, stiff neck, drowsiness, high||
5157|088|S|fever, sensitivity to light, eye pain, or severe nausea/vomiting.||
5157|089|S|   Lung problems may occur 1 to 6 hours after your treatment. You||
5157|090|S|will be monitored closely for any lung problems after your||
5157|091|S|treatment.||
5157|092|S|   A very serious allergic reaction to this drug is rare.||
5157|093|S|However, get medical help right away if you notice any symptoms||
5157|094|S|of a serious allergic reaction, including: rash, itching/swelling||
5157|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5157|096|S|breathing.||
5157|097|S|   This is not a complete list of possible side effects. If you||
5157|098|S|notice other effects not listed above, contact your doctor or||
5157|099|S|pharmacist.||
5157|100|S|   In the US -||
5157|101|S|   Call your doctor for medical advice about side effects. You||
5157|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5157|103|S|www.fda.gov/medwatch.||
5157|104|S|   In Canada - Call your doctor for medical advice about side||
5157|105|S|effects. You may report side effects to Health Canada at||
5157|106|S|1-866-234-2345.||
5157|107|B|||
5157|108|P|PRECAUTIONS:  See also Warning section.||
5157|109|P|   Before receiving this medication, tell your doctor or||
5157|110|P|pharmacist if you are allergic to it; or to other immunoglobulin||
5157|111|P|products (such as IgG); or if you have any other allergies. This||
5157|112|P|product may contain inactive ingredients, which can cause||
5157|113|P|allergic reactions or other problems. Talk to your pharmacist for||
5157|114|P|more details.||
5157|115|P|   Before using this medication, tell your doctor or pharmacist||
5157|116|P|your medical history, especially of: certain immune system||
5157|117|P|problems (immunoglobulin A deficiency, monoclonal gammopathies),||
5157|118|P|diabetes, high blood pressure, high blood fats (triglycerides),||
5157|119|P|migraines, current blood infection (sepsis), kidney disease,||
5157|120|P|severe loss of body fluids (dehydration).||
5157|121|P|   Tell your doctor of any recent or planned||
5157|122|P|immunizations/vaccinations. This medication may prevent a good||
5157|123|P|response to certain live viral vaccines (such as measles, mumps,||
5157|124|P|rubella, varicella). If you have recently received any of these||
5157|125|P|vaccines, your doctor may have you tested for a response or have||
5157|126|P|you vaccinated again later. If you plan on getting any of these||
5157|127|P|vaccines, your doctor will instruct you about the best time to||
5157|128|P|receive them so you get a good response.||
5157|129|P|   This medication is made from human blood. Even though the||
5157|130|P|blood is carefully tested, and this medication goes through a||
5157|131|P|special manufacturing process, there is an extremely small chance||
5157|132|P|that you may get infections from the medication (for example,||
5157|133|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
5157|134|P|more information.||
5157|135|P|   Before having surgery, tell your doctor or dentist about all||
5157|136|P|the products you use (including prescription drugs,||
5157|137|P|nonprescription drugs, and herbal products).||
5157|138|P|   During pregnancy, this medication should be used only when||
5157|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
5157|140|P|   It is unknown if this drug passes into breast milk. Consult||
5157|141|P|your doctor before breastfeeding.||
5157|142|B|||
5157|143|I|DRUG INTERACTIONS:  See also Warning section.||
5157|144|I|   Drug interactions may change how your medications work or||
5157|145|I|increase your risk for serious side effects. This document does||
5157|146|I|not contain all possible drug interactions. Keep a list of all||
5157|147|I|the products you use (including prescription/nonprescription||
5157|148|I|drugs and herbal products) and share it with your doctor and||
5157|149|I|pharmacist. Do not start, stop, or change the dosage of any||
5157|150|I|medicines without your doctor's approval.||
5157|151|I|   Some products that may interact with this drug include: drugs||
5157|152|I|that may harm the kidney (for example, aminoglycosides such as||
5157|153|I|gentamicin), "water pills" (diuretics such as furosemide).||
5157|154|B|||
5157|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5157|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5157|157|O|poison control center right away. US residents can call||
5157|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5157|159|B|||
5157|160|N|NOTES:  Lab and/or medical tests (such as kidney function, urine||
5157|161|N|volume) should be done while you are using this medication. Keep||
5157|162|N|all medical and lab appointments. Consult your doctor for more||
5157|163|N|details.||
5157|164|B|||
5157|165|D|MISSED DOSE:  It is important to get each dose of this medication||
5157|166|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
5157|167|D|right away for a new dosing schedule. Do not double the dose to||
5157|168|D|catch up.||
5157|169|B|||
5157|170|R|STORAGE:  Store in the refrigerator. Once the vial is opened,||
5157|171|R|this medication expires after 6 hours. Discard any unused||
5157|172|R|portion. Keep all medications away from children and pets.||
5157|173|R|   Do not flush medications down the toilet or pour them into a||
5157|174|R|drain unless instructed to do so. Properly discard this product||
5157|175|R|when it is expired or no longer needed. Consult your pharmacist||
5157|176|R|or local waste disposal company.||
5157|177|B|||
5157|178|A|Information last revised June 2025.||
5157|179|A|Copyright(c) 2025 First Databank, Inc.||
5157|180|B|||
5168|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5168|002|Z|does NOT have all possible information about this product. This||
5168|003|Z|information does not assure that this product is safe, effective,||
5168|004|Z|or appropriate for you. This information is not individual||
5168|005|Z|medical advice and does not substitute for the advice of your||
5168|006|Z|health care professional. Always ask your health care||
5168|007|Z|professional for complete information about this product and your||
5168|008|Z|specific health needs.||
5168|009|B|||
5168|010|T|CARVEDILOL - ORAL||
5168|011|F|(KAR-ve-DIL-ol)||
5168|012|B|||
5168|013|C|COMMON BRAND NAME(S): Coreg||
5168|014|B|||
5168|015|W|WARNING:  Do not stop taking this medication without consulting||
5168|016|W|your doctor. Some conditions may become worse when you suddenly||
5168|017|W|stop this drug. Some people who have suddenly stopped taking||
5168|018|W|similar drugs have had chest pain, heart attack, and irregular||
5168|019|W|heartbeat. If your doctor decides you should no longer use this||
5168|020|W|drug, your doctor may direct you to gradually decrease your dose||
5168|021|W|over 1 to 2 weeks.||
5168|022|W|   When gradually stopping this medication, it is recommended||
5168|023|W|that you temporarily limit physical activity to decrease strain||
5168|024|W|on the heart. Get medical help right away if you develop chest||
5168|025|W|pain/tightness/pressure, chest pain spreading to the||
5168|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
5168|027|W|fast/irregular heartbeat.||
5168|028|B|||
5168|029|U|USES:  Carvedilol is used to treat high blood pressure and heart||
5168|030|U|failure. It is also used after a heart attack to improve the||
5168|031|U|chance of survival if your heart is not pumping well. Lowering||
5168|032|U|high blood pressure helps prevent strokes, heart attacks, and||
5168|033|U|kidney problems.||
5168|034|U|   This drug works by blocking the action of certain natural||
5168|035|U|substances in your body, such as epinephrine, on the heart and||
5168|036|U|blood vessels. This effect lowers your heart rate, blood||
5168|037|U|pressure, and strain on your heart. Carvedilol belongs to a class||
5168|038|U|of drugs known as alpha and beta blockers.||
5168|039|B|||
5168|040|V|OTHER USES:  This section contains uses of this drug that are not||
5168|041|V|listed in the approved professional labeling for the drug but||
5168|042|V|that may be prescribed by your health care professional. Use this||
5168|043|V|drug for a condition that is listed in this section only if it||
5168|044|V|has been so prescribed by your health care professional.||
5168|045|V|   This drug may also be used for irregular heartbeat. It may||
5168|046|V|also be used after a heart attack to reduce the risk of another||
5168|047|V|heart attack.||
5168|048|B|||
5168|049|H|HOW TO USE:  See also Warning section.||
5168|050|H|   Read the Patient Information Leaflet if available from your||
5168|051|H|pharmacist before you start taking carvedilol and each time you||
5168|052|H|get a refill. If you have any questions, ask your doctor or||
5168|053|H|pharmacist.||
5168|054|H|   Take this medication by mouth with food as directed by your||
5168|055|H|doctor, usually twice daily.||
5168|056|H|   The dosage is based on your medical condition and response to||
5168|057|H|treatment. To reduce your risk of side effects, your doctor may||
5168|058|H|direct you to start this medication at a low dose and gradually||
5168|059|H|increase your dose. Follow your doctor's instructions carefully.||
5168|060|H|   Take this medication regularly to get the most benefit from||
5168|061|H|it. To help you remember, take it at the same times each day.||
5168|062|H|   For the treatment of high blood pressure, it may take 1 to 2||
5168|063|H|weeks before you get the full benefit of this drug. Keep taking||
5168|064|H|this medication even if you feel well. Most people with high||
5168|065|H|blood pressure do not feel sick.||
5168|066|H|   Tell your doctor if your condition does not get better or if||
5168|067|H|it gets worse (for example, your blood pressure readings remain||
5168|068|H|high or increase, you have worsening symptoms of heart failure||
5168|069|H|like increased shortness of breath).||
5168|070|B|||
5168|071|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
5168|072|S|   Dizziness, lightheadedness, drowsiness, diarrhea, impotence,||
5168|073|S|or tiredness may occur. If any of these effects last or get||
5168|074|S|worse, tell your doctor or pharmacist promptly.||
5168|075|S|   To reduce the risk of dizziness and lightheadedness, get up||
5168|076|S|slowly when rising from a sitting or lying position. The risk of||
5168|077|S|dizziness is highest within 1 hour after you take your dose.||
5168|078|S|Taking this medication with food and starting treatment with a||
5168|079|S|low dose and slowly increasing your dose as directed by your||
5168|080|S|doctor help to reduce the risk of dizziness.||
5168|081|S|   This drug may reduce blood flow to your hands and feet,||
5168|082|S|causing them to feel cold. Smoking may worsen this effect. Dress||
5168|083|S|warmly and avoid tobacco use.||
5168|084|S|   Remember that this medication has been prescribed because your||
5168|085|S|doctor has judged that the benefit to you is greater than the||
5168|086|S|risk of side effects. Many people using this medication do not||
5168|087|S|have serious side effects.||
5168|088|S|   Tell your doctor right away if you have any serious side||
5168|089|S|effects, including: very slow heartbeat, fainting, unusual||
5168|090|S|weakness, signs of kidney problems (such as change in the amount||
5168|091|S|of urine), numbness/tingling of the hands/feet, blue||
5168|092|S|fingers/toes, easy bruising/bleeding, mental/mood changes (such||
5168|093|S|as confusion, depression), seizures.||
5168|094|S|   Although this medication may be used to treat heart failure,||
5168|095|S|some people may rarely develop new or worsening symptoms of heart||
5168|096|S|failure, especially at the start of carvedilol treatment. Tell||
5168|097|S|your doctor right away if you develop any of these serious side||
5168|098|S|effects: shortness of breath, swelling ankles/feet, unusual||
5168|099|S|tiredness, unusual/sudden weight gain.||
5168|100|S|   A very serious allergic reaction to this drug is rare.||
5168|101|S|However, get medical help right away if you notice any symptoms||
5168|102|S|of a serious allergic reaction, including: rash, itching/swelling||
5168|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5168|104|S|breathing.||
5168|105|S|   This is not a complete list of possible side effects. If you||
5168|106|S|notice other effects not listed above, contact your doctor or||
5168|107|S|pharmacist.||
5168|108|S|   In the US -||
5168|109|S|   Call your doctor for medical advice about side effects. You||
5168|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5168|111|S|www.fda.gov/medwatch.||
5168|112|S|   In Canada - Call your doctor for medical advice about side||
5168|113|S|effects. You may report side effects to Health Canada at||
5168|114|S|1-866-234-2345.||
5168|115|B|||
5168|116|P|PRECAUTIONS:  Before taking carvedilol, tell your doctor or||
5168|117|P|pharmacist if you are allergic to it; or if you have any other||
5168|118|P|allergies. This product may contain inactive ingredients, which||
5168|119|P|can cause allergic reactions or other problems. Talk to your||
5168|120|P|pharmacist for more details.||
5168|121|P|   Before using this medication, tell your doctor or pharmacist||
5168|122|P|your medical history, especially of: certain types of||
5168|123|P|heartbeat/heart rhythm problems (such as slow/irregular||
5168|124|P|heartbeat, sick sinus syndrome, second- or third-degree||
5168|125|P|atrioventricular block), breathing problems (such as asthma,||
5168|126|P|chronic bronchitis, emphysema), severe heart failure requiring||
5168|127|P|hospitalization, liver disease, kidney disease, blood circulation||
5168|128|P|problems (such as Raynaud's disease, peripheral vascular||
5168|129|P|disease), serious allergic reactions including those needing||
5168|130|P|treatment with epinephrine, overactive thyroid disease||
5168|131|P|(hyperthyroidism), a certain adrenal gland tumor||
5168|132|P|(pheochromocytoma), other heart problems (such as Prinzmetal's||
5168|133|P|variant angina), a certain muscle disease (myasthenia gravis),||
5168|134|P|certain eye problems (cataracts, glaucoma).||
5168|135|P|   This drug may make you dizzy or drowsy or cause you to faint.||
5168|136|P|This is most likely to occur within 1 hour after taking your||
5168|137|P|dose, especially when you start carvedilol treatment or any time||
5168|138|P|your doctor increases your dose. During these periods, avoid||
5168|139|P|driving and doing hazardous tasks. Do not drive, use machinery,||
5168|140|P|or do anything that needs alertness until you can do it safely.||
5168|141|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
5168|142|P|drowsy. Limit alcoholic beverages. Talk to your doctor if you are||
5168|143|P|using marijuana (cannabis).||
5168|144|P|   People who wear contact lenses may have dry eyes while taking||
5168|145|P|this medication.||
5168|146|P|   Before having surgery (including cataract/glaucoma eye||
5168|147|P|surgery), tell your doctor or dentist if you are taking or have||
5168|148|P|ever taken this medication, and about all the other products you||
5168|149|P|use (including prescription drugs, nonprescription drugs, and||
5168|150|P|herbal products).||
5168|151|P|   This product may prevent the fast/pounding heartbeat you would||
5168|152|P|usually feel when your blood sugar level falls too low||
5168|153|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
5168|154|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
5168|155|P|blood sugar level, such as dizziness and sweating, are not||
5168|156|P|affected by this drug.||
5168|157|P|   If you have diabetes, this product may make it harder to||
5168|158|P|control your blood sugar levels. Check your blood sugar levels||
5168|159|P|regularly as directed by your doctor. Tell your doctor right away||
5168|160|P|if you have symptoms of high blood sugar such as increased||
5168|161|P|thirst/urination. Your doctor may need to adjust your diabetes||
5168|162|P|medication, exercise program, or diet.||
5168|163|P|   Children may be at greater risk for low blood sugar||
5168|164|P|(hypoglycemia) while using this drug, especially if they are||
5168|165|P|vomiting or not eating regularly. To help prevent low blood||
5168|166|P|sugar, make sure children eat regularly. If your child cannot eat||
5168|167|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
5168|168|P|as sweating, shaking), tell the doctor right away.||
5168|169|P|   Older adults may be more sensitive to the side effects of this||
5168|170|P|drug, especially dizziness and lightheadedness.||
5168|171|P|   Tell your doctor if you are pregnant or plan to become||
5168|172|P|pregnant. You should not become pregnant while using carvedilol.||
5168|173|P|Carvedilol may harm an unborn baby. If you become pregnant, talk||
5168|174|P|to your doctor right away about the risks and benefits of this||
5168|175|P|medication.||
5168|176|P|   It is unknown if carvedilol passes into breast milk. However,||
5168|177|P|it is unlikely to pass into breast milk in large amounts. There||
5168|178|P|is a low risk that it may have undesirable effects on a nursing||
5168|179|P|infant. Consult your doctor before breastfeeding.||
5168|180|B|||
5168|181|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5168|182|I|medications work or increase your risk for serious side effects.||
5168|183|I|This document does not contain all possible drug interactions.||
5168|184|I|Keep a list of all the products you use (including||
5168|185|I|prescription/nonprescription drugs and herbal products) and share||
5168|186|I|it with your doctor and pharmacist. Do not start, stop, or change||
5168|187|I|the dosage of any medicines without your doctor's approval.||
5168|188|I|   One product that may interact with this drug is: fingolimod.||
5168|189|I|   Some products have ingredients that could raise your heart||
5168|190|I|rate or blood pressure or worsen your heart failure. Tell your||
5168|191|I|pharmacist what products you are using, and ask how to use them||
5168|192|I|safely (especially cough-and-cold products, diet aids, or NSAIDs||
5168|193|I|such as ibuprofen/naproxen).||
5168|194|B|||
5168|195|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5168|196|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5168|197|O|poison control center right away. US residents can call||
5168|198|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5168|199|O|Symptoms of overdose may include: very slow heartbeat, severe||
5168|200|O|dizziness, fainting, slow/shallow breathing, seizures.||
5168|201|B|||
5168|202|N|NOTES:  Do not share this medication with others.||
5168|203|N|   Lifestyle changes that may help this medication work better||
5168|204|N|include exercising, stopping smoking, and eating a||
5168|205|N|low-cholesterol/low-fat diet. Consult your doctor for more||
5168|206|N|details.||
5168|207|N|   Have your blood pressure and pulse (heart rate) checked||
5168|208|N|regularly while taking this medication. Learn how to monitor your||
5168|209|N|own blood pressure and pulse at home, and share the results with||
5168|210|N|your doctor.||
5168|211|N|   Lab and/or medical tests (such as kidney/liver function)||
5168|212|N|should be done while you are taking this medication. Keep all||
5168|213|N|medical and lab appointments. Consult your doctor for more||
5168|214|N|details.||
5168|215|B|||
5168|216|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5168|217|D|remember. If it is near the time of the next dose, skip the||
5168|218|D|missed dose. Take your next dose at the regular time. Do not||
5168|219|D|double the dose to catch up.||
5168|220|B|||
5168|221|R|STORAGE:  Store at room temperature away from light and moisture.||
5168|222|R|Do not store in the bathroom. Keep all medications away from||
5168|223|R|children and pets.||
5168|224|R|   Do not flush medications down the toilet or pour them into a||
5168|225|R|drain unless instructed to do so. Properly discard this product||
5168|226|R|when it is expired or no longer needed. Consult your pharmacist||
5168|227|R|or local waste disposal company.||
5168|228|B|||
5168|229|A|Information last revised August 2024.||
5168|230|A|Copyright(c) 2025 First Databank, Inc.||
5168|231|B|||
5169|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5169|002|Z|does NOT have all possible information about this product. This||
5169|003|Z|information does not assure that this product is safe, effective,||
5169|004|Z|or appropriate for you. This information is not individual||
5169|005|Z|medical advice and does not substitute for the advice of your||
5169|006|Z|health care professional. Always ask your health care||
5169|007|Z|professional for complete information about this product and your||
5169|008|Z|specific health needs.||
5169|009|B|||
5169|010|T|DIPHTHERIA/TETANUS/PERTUSSIS VACCINE (PEDIATRIC) - INJECTION||
5169|011|F|(dip-THEER-ee-uh/TET-un-us/per-TUSS-iss)||
5169|012|B|||
5169|013|C|COMMON BRAND NAME(S): Daptacel, Infanrix, Tripedia||
5169|014|B|||
5169|015|U|USES:  This vaccine is used to help prevent diphtheria, tetanus||
5169|016|U|(lockjaw), and pertussis (whooping cough). Vaccination is the||
5169|017|U|best way to protect against these life-threatening diseases. This||
5169|018|U|vaccine works by increasing the body's natural defense (immunity)||
5169|019|U|against the bacteria.||
5169|020|U|   This vaccine is usually given to children between 6 weeks and||
5169|021|U|7 years old.||
5169|022|U|   Vaccines may not fully protect everyone who receives them.||
5169|023|B|||
5169|024|H|HOW TO USE:  Read all vaccine information available from your||
5169|025|H|health care professional before receiving the vaccine. If you||
5169|026|H|have any questions, ask your health care professional.||
5169|027|H|   This vaccine is given by injection into a muscle by a health||
5169|028|H|care professional. It is given in the upper arm for children and||
5169|029|H|in the thigh for infants.||
5169|030|H|   Vaccines are usually given in a series of doses to provide the||
5169|031|H|best protection. Closely follow the vaccination schedule provided||
5169|032|H|by your health care professional. To help you remember, mark your||
5169|033|H|calendar with a reminder.||
5169|034|H|   This vaccine may be given at the same time as other vaccines.||
5169|035|B|||
5169|036|S|SIDE EFFECTS:  Fever, irritability, vomiting, loss of appetite,||
5169|037|S|sleepiness, diarrhea, or pain/swelling/redness at the injection||
5169|038|S|site may occur. If any of these effects last or get worse, tell||
5169|039|S|the health care professional promptly.||
5169|040|S|   Rarely, some people have symptoms such as fainting, dizziness,||
5169|041|S|vision changes, or ringing in the ears just after getting a||
5169|042|S|vaccine injection. Tell the health care professional right away||
5169|043|S|if your child has any of these symptoms. Sitting or lying down||
5169|044|S|may help, since these symptoms usually don't last long.||
5169|045|S|   Remember that this vaccine has been prescribed because the||
5169|046|S|health care professional has judged that the benefit to your||
5169|047|S|child is greater than the risk of side effects. Many people using||
5169|048|S|this vaccine do not have serious side effects.||
5169|049|S|   Tell your health care professional right away if your child||
5169|050|S|has any serious side effects, including: high fever (105 degrees||
5169|051|S|F/40 degrees C or higher), nonstop crying (beginning within 48||
5169|052|S|hours of the injection and lasting longer than 3 hours),||
5169|053|S|seizures, little or no response to sound/touch, weak/floppy||
5169|054|S|muscles, severe pain/swelling at the injection site.||
5169|055|S|   A very serious allergic reaction to this vaccine is rare.||
5169|056|S|However, get medical help right away if you notice any symptoms||
5169|057|S|of a serious allergic reaction, including: rash, itching/swelling||
5169|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5169|059|S|breathing.||
5169|060|S|   This is not a complete list of possible side effects. If you||
5169|061|S|notice other effects not listed above, contact the health care||
5169|062|S|professional.||
5169|063|S|   Contact the health care professional for medical advice about||
5169|064|S|side effects. The following numbers do not provide medical||
5169|065|S|advice, but in the US you may report side effects to the Vaccine||
5169|066|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
5169|067|S|Canada, you may call the Vaccine Safety Section at Public Health||
5169|068|S|Agency of Canada at 1-866-844-0018.||
5169|069|B|||
5169|070|P|PRECAUTIONS:  Before your child receives this vaccine, tell the||
5169|071|P|health care professional if your child is allergic to it; or if||
5169|072|P|your child has any other allergies. This product may contain||
5169|073|P|inactive ingredients (such as latex found in some brands), which||
5169|074|P|can cause allergic reactions or other problems. Talk to your||
5169|075|P|health care professional for more details.||
5169|076|P|   Before receiving this vaccine, tell the health care||
5169|077|P|professional your child's medical history, especially of: current||
5169|078|P|fever/illness, nervous system disorders (such as seizures,||
5169|079|P|encephalopathy, Guillain-Barre syndrome), immune system disorders||
5169|080|P|(such as due to HIV infection, certain cancers such as||
5169|081|P|leukemia/lymphoma, cancer or radiation treatment), vaccination||
5169|082|P|history (including previous reactions to any vaccines).||
5169|083|P|   This vaccine is not usually used by adults. It is unlikely to||
5169|084|P|be used during pregnancy or breastfeeding. Consult the health||
5169|085|P|care professional if you have any questions about this vaccine.||
5169|086|B|||
5169|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5169|088|I|medications work or increase your risk for serious side effects.||
5169|089|I|This document does not contain all possible drug interactions.||
5169|090|I|Keep a list of all the products you use (including||
5169|091|I|prescription/nonprescription drugs and herbal products) and share||
5169|092|I|it with your health care professional. Do not start, stop, or||
5169|093|I|change the dosage of any medicines without your doctor's||
5169|094|I|approval.||
5169|095|I|   Some products that may interact with this vaccine are: drugs||
5169|096|I|that weaken the immune system (including cyclosporine,||
5169|097|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
5169|098|I|prednisone).||
5169|099|B|||
5169|100|O|OVERDOSE:  Not applicable.||
5169|101|B|||
5169|102|N|NOTES:  Keep all medical and lab appointments.||
5169|103|N|   Keep vaccine records for yourself and your children and||
5169|104|N|provide them to the health care professionals to prevent||
5169|105|N|unnecessary re-vaccinations.||
5169|106|B|||
5169|107|D|MISSED DOSE:  It is important that your child gets each||
5169|108|D|vaccination as scheduled. Ask when your child should get each||
5169|109|D|dose and mark your calendar with a reminder. If your child misses||
5169|110|D|a dose, call the health care professional to reschedule.||
5169|111|B|||
5169|112|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
5169|113|R|medications away from children and pets.||
5169|114|R|   Do not flush medications down the toilet or pour them into a||
5169|115|R|drain unless instructed to do so. Properly discard this product||
5169|116|R|when it is expired or no longer needed. Consult your pharmacist||
5169|117|R|or local waste disposal company.||
5169|118|B|||
5169|119|A|Information last revised February 2025.||
5169|120|A|Copyright(c) 2025 First Databank, Inc.||
5169|121|B|||
5172|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5172|002|Z|does NOT have all possible information about this product. This||
5172|003|Z|information does not assure that this product is safe, effective,||
5172|004|Z|or appropriate for you. This information is not individual||
5172|005|Z|medical advice and does not substitute for the advice of your||
5172|006|Z|health care professional. Always ask your health care||
5172|007|Z|professional for complete information about this product and your||
5172|008|Z|specific health needs.||
5172|009|B|||
5172|010|T|PROMETHAZINE/PHENYLEPHRINE/CODEINE - ORAL||
5172|011|F|(pro-METH-uh-zeen/fen-ill-EFF-rin/KOE-deen)||
5172|012|B|||
5172|013|C|COMMON BRAND NAME(S): Phenergan VC w/Codeine||
5172|014|B|||
5172|015|W|WARNING:  This medication has a risk for abuse and addiction,||
5172|016|W|which can lead to overdose and death. This medication may also||
5172|017|W|cause severe, possibly fatal, breathing problems. To lower your||
5172|018|W|risk, your doctor should have you take the smallest dose that||
5172|019|W|works, and take it for the shortest possible time. See also How||
5172|020|W|to Use section for more information about addiction.||
5172|021|W|   The risk for severe breathing problems is higher when you||
5172|022|W|start this medication, or if you take the wrong dose or take more||
5172|023|W|of this medication than prescribed. Taking this medication with||
5172|024|W|alcohol or other drugs that can cause drowsiness or breathing||
5172|025|W|problems may cause very serious side effects, including death.||
5172|026|W|Also, other medications can affect the removal of this product||
5172|027|W|from your body, which may affect how it works. Be sure you know||
5172|028|W|how to take this product and what other drugs you should avoid||
5172|029|W|taking with it. See also Drug Interactions section. Get medical||
5172|030|W|help right away if any of these very serious side effects occur:||
5172|031|W|slow/shallow breathing, unusual lightheadedness, severe||
5172|032|W|drowsiness/dizziness, difficulty waking up.||
5172|033|W|   Keep this medicine in a safe place to prevent theft, misuse,||
5172|034|W|or abuse. If someone accidentally swallows this drug, get medical||
5172|035|W|help right away.||
5172|036|W|   Before using this medication, women of childbearing age should||
5172|037|W|talk with their doctor(s) about the risks and benefits. Tell your||
5172|038|W|doctor if you are pregnant or think you may be pregnant. During||
5172|039|W|pregnancy, this medication is not recommended. It may slightly||
5172|040|W|increase the risk of birth defects if used during the first two||
5172|041|W|months of pregnancy. Also, using it for a long time or in high||
5172|042|W|doses near the expected delivery date may harm the unborn baby.||
5172|043|W|To lessen the risk, take the smallest effective dose for the||
5172|044|W|shortest possible time. Babies born to mothers who use this drug||
5172|045|W|for a long time may develop severe (possibly fatal) withdrawal||
5172|046|W|symptoms. Tell the doctor right away if you notice any symptoms||
5172|047|W|in your newborn baby such as crying that doesn't stop,||
5172|048|W|slow/shallow breathing, irritability, shaking, vomiting,||
5172|049|W|diarrhea, poor feeding, or difficulty gaining weight.||
5172|050|B|||
5172|051|U|USES:  This combination medication is used to treat symptoms||
5172|052|U|caused by the common cold, flu, allergies, or other breathing||
5172|053|U|illnesses (such as sinusitis, bronchitis). Promethazine is an||
5172|054|U|antihistamine that relieves watery eyes, itchy eyes/nose/throat,||
5172|055|U|runny nose, and sneezing. Phenylephrine is a decongestant that||
5172|056|U|relieves stuffy nose symptoms. Codeine is an opioid cough||
5172|057|U|suppressant (antitussive) that affects a certain part of the||
5172|058|U|brain, reducing the urge to cough.||
5172|059|U|   Opioid cough suppressants should not be used by children||
5172|060|U|younger than 18 years. Children are at higher risk for serious||
5172|061|U|(even fatal) side effects, especially breathing problems. Talk||
5172|062|U|with the doctor about the risks and benefits of this medication.||
5172|063|U|   Cough-and-cold products do not cure colds. Cough due to a||
5172|064|U|common cold often does not need to be treated with medicine. Ask||
5172|065|U|your doctor or pharmacist about other ways to relieve cough and||
5172|066|U|cold symptoms, such as drinking enough fluids, using a||
5172|067|U|humidifier, or saline nose drops/spray.||
5172|068|B|||
5172|069|H|HOW TO USE:  Read the Medication Guide provided by your||
5172|070|H|pharmacist before you start taking||
5172|071|H|promethazine/phenylephrine/codeine and each time you get a||
5172|072|H|refill. If you have any questions, ask your doctor or pharmacist.||
5172|073|H|   Take this medication by mouth with or without food as directed||
5172|074|H|by your doctor, usually every 4 to 6 hours as needed. This||
5172|075|H|medication can be taken with food if stomach upset occurs. Drink||
5172|076|H|plenty of fluids when you use this medication unless otherwise||
5172|077|H|directed by your doctor.||
5172|078|H|   Carefully measure the dose using a special measuring||
5172|079|H|device/spoon. Do not use a household spoon because you may not||
5172|080|H|get the correct dose.||
5172|081|H|   Do not increase your dose or use this product more often or||
5172|082|H|for longer than prescribed. Your condition will not improve any||
5172|083|H|faster, and your risk of side effects will increase.||
5172|084|H|   If you suddenly stop using this medication, you may have||
5172|085|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
5172|086|H|nose, nausea, sweating, muscle aches). To help prevent||
5172|087|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
5172|088|H|more likely if you have used this medication for a long time||
5172|089|H|(more than a few weeks) or in high doses. Tell your doctor or||
5172|090|H|pharmacist right away if you have withdrawal.||
5172|091|H|   Though it helps many people, this medication may sometimes||
5172|092|H|cause addiction. This risk may be higher if you have a||
5172|093|H|mental/mood disorder or a substance use disorder (such as overuse||
5172|094|H|of or addiction to drugs/alcohol). Take this medication exactly||
5172|095|H|as prescribed to lower the risk of addiction. Ask your doctor or||
5172|096|H|pharmacist for more details.||
5172|097|H|   When used for an extended time, this medication may not work||
5172|098|H|as well and may require different dosing. Talk with your doctor||
5172|099|H|if this medication stops working well.||
5172|100|H|   Tell your doctor if your cough does not get better in 5 days.||
5172|101|H|Also, tell your doctor if your condition gets worse, or if you||
5172|102|H|have a headache that doesn't go away, fever, or rash. These may||
5172|103|H|be symptoms of a serious medical problem and should be checked by||
5172|104|H|a doctor.||
5172|105|B|||
5172|106|S|SIDE EFFECTS:  See also Warning section.||
5172|107|S|   Drowsiness, dizziness, headache, lightheadedness, blurred||
5172|108|S|vision, upset stomach, nausea, nervousness, trouble sleeping,||
5172|109|S|constipation, or dry mouth may occur. If any of these effects||
5172|110|S|last or get worse, tell your doctor or pharmacist promptly.||
5172|111|S|   To reduce the risk of dizziness and lightheadedness, get up||
5172|112|S|slowly when rising from a sitting or lying position.||
5172|113|S|   This medication can dry up and thicken mucus in your lungs,||
5172|114|S|making it more difficult to breathe and clear your lungs. To help||
5172|115|S|prevent this effect, drink plenty of fluids unless otherwise||
5172|116|S|directed by your doctor.||
5172|117|S|   Remember that this medication has been prescribed because your||
5172|118|S|doctor has judged that the benefit to you is greater than the||
5172|119|S|risk of side effects. Many people using this medication do not||
5172|120|S|have serious side effects.||
5172|121|S|   This medication may raise your blood pressure. Check your||
5172|122|S|blood pressure regularly and tell your doctor if the results are||
5172|123|S|high.||
5172|124|S|   Tell your doctor right away if you have any serious side||
5172|125|S|effects, including: interrupted breathing during sleep (sleep||
5172|126|S|apnea), involuntary behaviors/movements (such as fixed upward||
5172|127|S|stare, neck twisting, tongue movements), mental/mood changes||
5172|128|S|(such as hallucinations), ringing in the ears, shaking (tremors),||
5172|129|S|trouble urinating, weakness, trouble swallowing.||
5172|130|S|   Get medical help right away if you have any very serious side||
5172|131|S|effects, including: nausea/vomiting that doesn't stop, chest||
5172|132|S|pain, easy bruising/bleeding, slow heartbeat, severe abdominal||
5172|133|S|pain, yellowing eyes/skin.||
5172|134|S|   Codeine is changed into a strong opioid drug (morphine) in||
5172|135|S|your body. In some people, this change happens faster and more||
5172|136|S|completely than usual, which increases the risk of very serious||
5172|137|S|side effects. Get medical help right away if you notice any of||
5172|138|S|the following: slow/shallow breathing, severe||
5172|139|S|drowsiness/difficulty waking up, confusion.||
5172|140|S|   This medication may rarely cause a very serious condition||
5172|141|S|called neuroleptic malignant syndrome (NMS). Get medical help||
5172|142|S|right away if you have any of the following symptoms: fever,||
5172|143|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
5172|144|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
5172|145|S|signs of kidney problems (such as change in the amount of urine).||
5172|146|S|   A very serious allergic reaction to this drug is rare.||
5172|147|S|However, get medical help right away if you notice any symptoms||
5172|148|S|of a serious allergic reaction, including: rash, itching/swelling||
5172|149|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5172|150|S|breathing.||
5172|151|S|   This is not a complete list of possible side effects. If you||
5172|152|S|notice other side effects not listed above, contact your doctor||
5172|153|S|or pharmacist.||
5172|154|S|   In the US -||
5172|155|S|   Call your doctor for medical advice about side effects. You||
5172|156|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5172|157|S|www.fda.gov/medwatch.||
5172|158|S|   In Canada - Call your doctor for medical advice about side||
5172|159|S|effects. You may report side effects to Health Canada at||
5172|160|S|1-866-234-2345.||
5172|161|B|||
5172|162|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
5172|163|P|pharmacist if you are allergic to any of its ingredients; or to||
5172|164|P|opioid pain relievers (such as morphine); or if you have any||
5172|165|P|other allergies. This product may contain inactive ingredients,||
5172|166|P|which can cause allergic reactions or other problems. Talk to||
5172|167|P|your pharmacist for more details.||
5172|168|P|   Before using this medication, tell your doctor or pharmacist||
5172|169|P|your medical history, especially of: abdominal problems (such as||
5172|170|P|chronic constipation, ileus, pancreatitis), gallbladder disease,||
5172|171|P|adrenal gland problem (such as Addison's disease), blood/immune||
5172|172|P|system problems (such as bone marrow depression), brain disorders||
5172|173|P|(such as seizures, head injury, tumor, increased intracranial||
5172|174|P|pressure), breathing problems (such as asthma, emphysema, sleep||
5172|175|P|apnea), diabetes, glaucoma, heart problems (such as angina,||
5172|176|P|irregular heartbeat), high blood pressure, kidney disease, liver||
5172|177|P|disease, mental/mood problems (such as depression, psychosis), a||
5172|178|P|certain spinal problem (kyphoscoliosis), obesity,||
5172|179|P|stomach/intestinal problems (such as ulcers, blockage), thyroid||
5172|180|P|disease, trouble urinating (such as due to enlarged prostate or||
5172|181|P|urethral stricture), personal or family history of a substance||
5172|182|P|use disorder (such as overuse of or addiction to drugs/alcohol).||
5172|183|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5172|184|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5172|185|P|machinery, or do anything that needs alertness until you can do||
5172|186|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5172|187|P|are using marijuana (cannabis).||
5172|188|P|   Before having surgery, tell your doctor or dentist about all||
5172|189|P|the products you use (including prescription drugs,||
5172|190|P|nonprescription drugs, and herbal products).||
5172|191|P|   This medication may make you more sensitive to the sun. Limit||
5172|192|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5172|193|P|sunscreen and wear protective clothing when outdoors. Tell your||
5172|194|P|doctor right away if you get sunburned or have skin||
5172|195|P|blisters/redness.||
5172|196|P|   This medication may contain sugar and/or alcohol. Caution is||
5172|197|P|advised if you have diabetes, alcohol dependence, or liver||
5172|198|P|disease. Ask your doctor or pharmacist about using this product||
5172|199|P|safely.||
5172|200|P|   Older adults may be more sensitive to the effects of the drug,||
5172|201|P|especially dizziness, drowsiness, confusion, constipation,||
5172|202|P|trouble urinating, trouble sleeping, fast/irregular heartbeat, or||
5172|203|P|slow/shallow breathing. Dizziness, drowsiness, and confusion can||
5172|204|P|increase the risk of falling.||
5172|205|P|   Tell your doctor if you are pregnant or think you may be||
5172|206|P|pregnant. During pregnancy, this product is not recommended. It||
5172|207|P|may harm an unborn baby. Talk to your doctor about the risks and||
5172|208|P|benefits of this medication. See also Warning section.||
5172|209|P|   This product passes into breast milk and may have undesirable||
5172|210|P|effects on a nursing infant (such as unusual sleepiness,||
5172|211|P|difficulty feeding, trouble breathing, or unusual limpness).||
5172|212|P|Consult your doctor before breastfeeding.||
5172|213|B|||
5172|214|I|DRUG INTERACTIONS:  See also Warning section.||
5172|215|I|   Drug interactions may change how your medications work or||
5172|216|I|increase your risk for serious side effects. This document does||
5172|217|I|not contain all possible drug interactions. Keep a list of all||
5172|218|I|the products you use (including prescription/nonprescription||
5172|219|I|drugs and herbal products) and share it with your doctor and||
5172|220|I|pharmacist. Do not start, stop, or change the dosage of any||
5172|221|I|medicines without your doctor's approval.||
5172|222|I|   Some products that may interact with this drug include:||
5172|223|I|antihistamines applied to the skin (such as diphenhydramine||
5172|224|I|cream, ointment, spray), cimetidine, metoclopramide, naltrexone,||
5172|225|I|samidorphan.||
5172|226|I|   Taking MAO inhibitors with this medication may cause a serious||
5172|227|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
5172|228|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
5172|229|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
5172|230|I|selegiline, tranylcypromine) during treatment with this||
5172|231|I|medication. Most MAO inhibitors should also not be taken for two||
5172|232|I|weeks before treatment with this medication. Ask your doctor when||
5172|233|I|to start or stop taking this medication.||
5172|234|I|   The risk of serious side effects (such as slow/shallow||
5172|235|I|breathing, severe drowsiness/dizziness) may be increased if this||
5172|236|I|medication is taken with other products that may also cause||
5172|237|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5172|238|I|if you are taking other products such as other opioid pain or||
5172|239|I|cough relievers (such as morphine, hydrocodone), alcohol,||
5172|240|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
5172|241|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
5172|242|I|carisoprodol, cyclobenzaprine), or other antihistamines (such as||
5172|243|I|cetirizine, diphenhydramine).||
5172|244|I|   Check the labels on all your medicines (such as allergy or||
5172|245|I|cough-and-cold products) because they may contain ingredients||
5172|246|I|that cause drowsiness. Ask your pharmacist about using those||
5172|247|I|products safely.||
5172|248|I|   Other medications can affect the removal of||
5172|249|I|promethazine/phenylephrine/codeine from your body, which may||
5172|250|I|affect how promethazine/phenylephrine/codeine works. Examples||
5172|251|I|include azole antifungals (such as ketoconazole), bupropion,||
5172|252|I|fluoxetine, macrolide antibiotics (such as erythromycin),||
5172|253|I|paroxetine, quinidine, rifamycins (such as rifabutin, rifampin),||
5172|254|I|ritonavir, certain drugs used to treat seizures (such as||
5172|255|I|carbamazepine, phenytoin), among others.||
5172|256|I|   This medication may interfere with certain lab tests (such as||
5172|257|I|some pregnancy tests, blood sugar tests, amylase/lipase levels,||
5172|258|I|allergy skin test), possibly causing false test results. Make||
5172|259|I|sure lab personnel and all your doctors know you use this drug.||
5172|260|B|||
5172|261|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5172|262|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5172|263|O|poison control center right away. US residents can call||
5172|264|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5172|265|O|Symptoms of overdose may include: confusion, cold/clammy skin,||
5172|266|O|fast/slow/irregular heartbeat, slow/shallow breathing, seizures,||
5172|267|O|fainting, coma.||
5172|268|B|||
5172|269|N|NOTES:  Do not share this medication with others. Sharing it is||
5172|270|N|against the law.||
5172|271|B|||
5172|272|D|MISSED DOSE:  If you are prescribed this medication on a regular||
5172|273|D|schedule and miss a dose, take it as soon as you remember. If it||
5172|274|D|is near the time of the next dose, skip the missed dose. Take||
5172|275|D|your next dose at the regular time. Do not double the dose to||
5172|276|D|catch up.||
5172|277|B|||
5172|278|R|STORAGE:  Store at room temperature away from light and moisture.||
5172|279|R|Do not store in the bathroom. Do not freeze. Keep all medications||
5172|280|R|away from children and pets.||
5172|281|R|   Do not flush medications down the toilet or pour them into a||
5172|282|R|drain unless instructed to do so. Properly discard this product||
5172|283|R|when it is expired or no longer needed. Consult your pharmacist||
5172|284|R|or local waste disposal company.||
5172|285|B|||
5172|286|A|Information last revised August 2025.||
5172|287|A|Copyright(c) 2025 First Databank, Inc.||
5172|288|B|||
5174|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5174|002|Z|does NOT have all possible information about this product. This||
5174|003|Z|information does not assure that this product is safe, effective,||
5174|004|Z|or appropriate for you. This information is not individual||
5174|005|Z|medical advice and does not substitute for the advice of your||
5174|006|Z|health care professional. Always ask your health care||
5174|007|Z|professional for complete information about this product and your||
5174|008|Z|specific health needs.||
5174|009|B|||
5174|010|T|SODIUM CLODRONATE - ORAL||
5174|011|F|(SO-dee-um KLOD-row-nate)||
5174|012|B|||
5174|013|U|USES:  Sodium clodronate is used with other drugs to reduce the||
5174|014|U|breakdown of bone caused by cancer that has spread to the bones.||
5174|015|U|It is also used to treat a high level of calcium in the blood||
5174|016|U|that may occur with some cancers. Sodium clodronate works by||
5174|017|U|slowing bone loss and by decreasing the amount of calcium||
5174|018|U|released from your bones into your blood. This medication belongs||
5174|019|U|to a class of drugs called bisphosphonates.||
5174|020|B|||
5174|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5174|022|H|from your pharmacist before you start taking sodium clodronate||
5174|023|H|and each time you get a refill. If you have any questions, ask||
5174|024|H|your doctor or pharmacist.||
5174|025|H|   Take this medication by mouth without food as directed by your||
5174|026|H|doctor, usually 1 to 2 times a day. Take it on an empty stomach||
5174|027|H|at least 1 to 2 hours before or 1 to 2 hours after eating. The||
5174|028|H|timing depends on the brand you use, so follow the directions for||
5174|029|H|your brand.||
5174|030|H|   Take sodium clodronate with a full glass of plain water (6 to||
5174|031|H|8 ounces, 180 to 240 milliliters). Do not take it with milk or||
5174|032|H|any other beverage. Swallow this medication whole. After taking||
5174|033|H|this medication, stay fully upright (sitting, standing, or||
5174|034|H|walking) and do not lie down for at least 30 minutes.||
5174|035|H|   Do not take sodium clodronate at the same time as food or||
5174|036|H|other medications because they may prevent its absorption. Take||
5174|037|H|this medication 1 to 2 hours (depending on your brand) before or||
5174|038|H|1 to 2 hours after taking any products that contain aluminum,||
5174|039|H|calcium, iron, magnesium, or zinc. Some examples include||
5174|040|H|antacids, quinapril, vitamins/minerals, dairy products (such as||
5174|041|H|milk, yogurt), and juice with added calcium.||
5174|042|H|   Drink plenty of fluids during treatment with this medication||
5174|043|H|unless otherwise directed by your doctor.||
5174|044|H|   The dosage is based on your medical condition and response to||
5174|045|H|treatment. Do not take more of this medication than prescribed.||
5174|046|H|   Take this medication regularly to get the most benefit from||
5174|047|H|it. To help you remember, take it at the same time(s) each day.||
5174|048|B|||
5174|049|S|SIDE EFFECTS:  Nausea or diarrhea may rarely occur. If any of||
5174|050|S|these effects last or get worse, tell your doctor or pharmacist||
5174|051|S|promptly.||
5174|052|S|   Remember that this medication has been prescribed because your||
5174|053|S|doctor has judged that the benefit to you is greater than the||
5174|054|S|risk of side effects. Many people using this medication do not||
5174|055|S|have serious side effects.||
5174|056|S|   Tell your doctor right away if you have any serious side||
5174|057|S|effects, including: new or worsening bone/joint/muscle pain, new||
5174|058|S|or unusual hip/thigh/groin pain, mouth/jaw pain, muscle spasms,||
5174|059|S|mental/mood changes.||
5174|060|S|   Medications similar to sodium clodronate may rarely cause||
5174|061|S|irritation and ulcers in your stomach or esophagus. Get medical||
5174|062|S|help right away if any of these very serious side effects occur:||
5174|063|S|new/severe/worsening heartburn, chest pain, difficult/painful||
5174|064|S|swallowing, stomach/abdominal pain, black/tarry stools, vomit||
5174|065|S|that looks like coffee grounds.||
5174|066|S|   A very serious allergic reaction to this drug is rare.||
5174|067|S|However, get medical help right away if you notice any symptoms||
5174|068|S|of a serious allergic reaction, including: rash, itching/swelling||
5174|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5174|070|S|breathing.||
5174|071|S|   This is not a complete list of possible side effects. If you||
5174|072|S|notice other effects not listed above, contact your doctor or||
5174|073|S|pharmacist.||
5174|074|S|   In the US -||
5174|075|S|   Call your doctor for medical advice about side effects. You||
5174|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5174|077|S|www.fda.gov/medwatch.||
5174|078|S|   In Canada - Call your doctor for medical advice about side||
5174|079|S|effects. You may report side effects to Health Canada at||
5174|080|S|1-866-234-2345.||
5174|081|B|||
5174|082|P|PRECAUTIONS:  Before taking sodium clodronate, tell your doctor||
5174|083|P|or pharmacist if you are allergic to it; or to other||
5174|084|P|bisphosphonates (such as alendronate); or if you have any other||
5174|085|P|allergies. This product may contain inactive ingredients (such as||
5174|086|P|soya lecithin from soybeans found in some brands), which can||
5174|087|P|cause allergic reactions or other problems. Some people who are||
5174|088|P|allergic to peanuts may also be allergic to soy. Talk to your||
5174|089|P|pharmacist for more details.||
5174|090|P|   Before using this medication, tell your doctor or pharmacist||
5174|091|P|your medical history, especially of: kidney disease, inability to||
5174|092|P|sit upright or stand for at least 30 minutes, difficult/painful||
5174|093|P|swallowing, esophagus/stomach/intestinal problems (such as||
5174|094|P|heartburn, ulcers, colitis).||
5174|095|P|   Some people taking sodium clodronate may have serious jawbone||
5174|096|P|problems. Your doctor should check your mouth before you start||
5174|097|P|this medication. Tell your dentist that you are taking this||
5174|098|P|medication before you have any dental work done. To help prevent||
5174|099|P|jawbone problems, have regular dental exams and learn how to keep||
5174|100|P|your teeth and gums healthy. If you have jaw pain, tell your||
5174|101|P|doctor and dentist right away.||
5174|102|P|   Before having any surgery (especially dental procedures), tell||
5174|103|P|your doctor and dentist about this medication and all other||
5174|104|P|products you use (including prescription drugs, nonprescription||
5174|105|P|drugs, and herbal products). Your doctor or dentist may tell you||
5174|106|P|to stop taking sodium clodronate before your surgery. Ask for||
5174|107|P|specific instructions about stopping or starting this medication.||
5174|108|P|   Tell your doctor if you are pregnant or plan to become||
5174|109|P|pregnant. Sodium clodronate may stay in your body for many years.||
5174|110|P|You should not become pregnant while using sodium clodronate.||
5174|111|P|Sodium clodronate may harm an unborn baby. If you become||
5174|112|P|pregnant, talk to your doctor right away about the risks and||
5174|113|P|benefits of this medication.||
5174|114|P|   It is unknown if this medication passes into breast milk.||
5174|115|P|Consult your doctor before breastfeeding.||
5174|116|B|||
5174|117|I|DRUG INTERACTIONS:  See also the How to Use section.||
5174|118|I|   Drug interactions may change how your medications work or||
5174|119|I|increase your risk for serious side effects. This document does||
5174|120|I|not contain all possible drug interactions. Keep a list of all||
5174|121|I|the products you use (including prescription/nonprescription||
5174|122|I|drugs and herbal products) and share it with your doctor and||
5174|123|I|pharmacist. Do not start, stop, or change the dosage of any||
5174|124|I|medicines without your doctor's approval.||
5174|125|I|   This medication may interfere with certain lab tests (such as||
5174|126|I|bone imaging tests), possibly causing false test results. Make||
5174|127|I|sure lab personnel and all your doctors know you use this drug.||
5174|128|B|||
5174|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5174|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5174|131|O|poison control center right away. US residents can call||
5174|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5174|133|O|Symptoms of overdose may include: muscle spasms, mental/mood||
5174|134|O|changes.||
5174|135|B|||
5174|136|N|NOTES:  Do not share this medication with others.||
5174|137|N|   Eat well-balanced meals that contain adequate calcium and||
5174|138|N|vitamin D. Consult your doctor or pharmacist for more details.||
5174|139|N|   Lab and/or medical tests (such as calcium and other blood||
5174|140|N|mineral levels, kidney/liver function) should be done while you||
5174|141|N|are taking this medication. Keep all medical and lab||
5174|142|N|appointments. Consult your doctor for more details.||
5174|143|B|||
5174|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
5174|145|D|on an empty stomach. If it is near the time of the next dose,||
5174|146|D|skip the missed dose. Take your next dose at the regular time. Do||
5174|147|D|not double the dose to catch up.||
5174|148|B|||
5174|149|R|STORAGE:  Store at room temperature away from light and moisture.||
5174|150|R|Do not store in the bathroom. Keep all medications away from||
5174|151|R|children and pets.||
5174|152|R|   Do not flush medications down the toilet or pour them into a||
5174|153|R|drain unless instructed to do so. Properly discard this product||
5174|154|R|when it is expired or no longer needed. Consult your pharmacist||
5174|155|R|or local waste disposal company.||
5174|156|B|||
5174|157|A|Information last revised September 2025.||
5174|158|A|Copyright(c) 2025 First Databank, Inc.||
5174|159|B|||
5179|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5179|002|Z|does NOT have all possible information about this product. This||
5179|003|Z|information does not assure that this product is safe, effective,||
5179|004|Z|or appropriate for you. This information is not individual||
5179|005|Z|medical advice and does not substitute for the advice of your||
5179|006|Z|health care professional. Always ask your health care||
5179|007|Z|professional for complete information about this product and your||
5179|008|Z|specific health needs.||
5179|009|B|||
5179|010|T|AMPHOTERICIN - INJECTION||
5179|011|F|(AM-foe-TER-i-sin)||
5179|012|B|||
5179|013|C|COMMON BRAND NAME(S): Fungizone||
5179|014|B|||
5179|015|W|WARNING:  Amphotericin should be used only to treat serious,||
5179|016|W|possibly fatal fungal infections. This medication should not be||
5179|017|W|used for less severe infections in limited areas of the body||
5179|018|W|(such as fungal infection of the mouth/esophagus, vaginal yeast||
5179|019|W|infections) in patients with normal white blood cell counts.||
5179|020|B|||
5179|021|U|USES:  See also Warning section.||
5179|022|U|   This medication is used to treat a variety of serious,||
5179|023|U|possibly fatal fungal infections. It works by stopping the growth||
5179|024|U|of fungi.||
5179|025|B|||
5179|026|V|OTHER USES:  This section contains uses of this drug that are not||
5179|027|V|listed in the approved professional labeling for the drug but||
5179|028|V|that may be prescribed by your health care professional. Use this||
5179|029|V|drug for a condition that is listed in this section only if it||
5179|030|V|has been so prescribed by your health care professional.||
5179|031|V|   This drug may also be used to reduce the risk of fungal||
5179|032|V|infections in people with fevers and low white blood cell||
5179|033|V|(neutrophil) counts or people with weakened immune systems (such||
5179|034|V|as due to HIV, organ transplant, or cancer).||
5179|035|B|||
5179|036|H|HOW TO USE:  This medication is usually given by injection into a||
5179|037|H|vein as directed by your doctor, usually once a day or every||
5179|038|H|other day. It should be injected slowly over 2 to 6 hours. Your||
5179|039|H|doctor may give you a smaller dose first to test your response to||
5179|040|H|the medication. The dosage is based on your medical condition,||
5179|041|H|weight, response to the test dose, and response to treatment. If||
5179|042|H|this medication is stopped for 7 days or longer, then it should||
5179|043|H|be restarted at the lowest dose and slowly increased.||
5179|044|H|   If you are giving this medication to yourself at home, learn||
5179|045|H|all preparation and usage instructions from your health care||
5179|046|H|professional. Before using, check this product for particles or||
5179|047|H|discoloration. If either is present, do not use the liquid. Learn||
5179|048|H|how to store and discard medical supplies safely.||
5179|049|H|   Infusion reactions may happen during the infusion of this||
5179|050|H|drug. Your doctor may prescribe other medications (including||
5179|051|H|acetaminophen, diphenhydramine, corticosteroids such as||
5179|052|H|hydrocortisone) before each treatment to help prevent these side||
5179|053|H|effects. Tell your doctor right away if you have any symptoms of||
5179|054|H|infusion reactions such as fever, shaking, chills, flushing, loss||
5179|055|H|of appetite, dizziness, nausea, vomiting, headache, shortness of||
5179|056|H|breath, or fast breathing. Your doctor may give you other||
5179|057|H|medications to help with these side effects.||
5179|058|H|   It may be necessary to continue this medication for several||
5179|059|H|weeks to several months in order to treat certain infections.||
5179|060|H|Stopping the medication too early may result in a return of the||
5179|061|H|infection.||
5179|062|H|   Tell your doctor if your condition lasts or gets worse.||
5179|063|B|||
5179|064|S|SIDE EFFECTS:  See also How to Use section.||
5179|065|S|   Remember that this medication has been prescribed because your||
5179|066|S|doctor has judged that the benefit to you is greater than the||
5179|067|S|risk of side effects. Many people using this medication do not||
5179|068|S|have serious side effects.||
5179|069|S|   Tell your doctor right away if you have any serious side||
5179|070|S|effects, including: swelling/pain at injection site, muscle/joint||
5179|071|S|pain, unusual tiredness, weakness, muscle cramping, signs of||
5179|072|S|kidney problems (such as change in the amount of urine, painful||
5179|073|S|urination), numbness/tingling of arms/legs, vision changes,||
5179|074|S|hearing changes (such as ringing in the ears), signs of liver||
5179|075|S|problems (such as dark urine, stomach/abdominal pain, yellowing||
5179|076|S|eyes/skin), swelling ankles/feet, fast/slow/irregular heartbeat,||
5179|077|S|cold sweats, blue lips, easy bruising/bleeding, other signs of||
5179|078|S|infection (such as sore throat that doesn't go away, fever,||
5179|079|S|chills), mental/mood changes, seizures, black stools, vomit that||
5179|080|S|looks like coffee grounds.||
5179|081|S|   A very serious allergic reaction to this drug is rare.||
5179|082|S|However, get medical help right away if you notice any symptoms||
5179|083|S|of a serious allergic reaction, including: rash, itching/swelling||
5179|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5179|085|S|breathing.||
5179|086|S|   This is not a complete list of possible side effects. If you||
5179|087|S|notice other effects not listed above, contact your doctor or||
5179|088|S|pharmacist.||
5179|089|S|   In the US -||
5179|090|S|   Call your doctor for medical advice about side effects. You||
5179|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5179|092|S|www.fda.gov/medwatch.||
5179|093|S|   In Canada - Call your doctor for medical advice about side||
5179|094|S|effects. You may report side effects to Health Canada at||
5179|095|S|1-866-234-2345.||
5179|096|B|||
5179|097|P|PRECAUTIONS:  Before using amphotericin, tell your doctor or||
5179|098|P|pharmacist if you are allergic to it; or if you have any other||
5179|099|P|allergies. This product may contain inactive ingredients, which||
5179|100|P|can cause allergic reactions or other problems. Talk to your||
5179|101|P|pharmacist for more details.||
5179|102|P|   Before using this medication, tell your doctor or pharmacist||
5179|103|P|your medical history, especially of: white blood cell (leukocyte)||
5179|104|P|transfusions, heart disease (such as irregular heartbeat, heart||
5179|105|P|failure), liver disease, kidney disease.||
5179|106|P|   Before having surgery, tell your doctor or dentist about all||
5179|107|P|the products you use (including prescription drugs,||
5179|108|P|nonprescription drugs, and herbal products).||
5179|109|P|   During pregnancy, this medication should be used only when||
5179|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
5179|111|P|   It is unknown if this drug passes into breast milk. Consult||
5179|112|P|your doctor before breastfeeding.||
5179|113|B|||
5179|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5179|115|I|medications work or increase your risk for serious side effects.||
5179|116|I|This document does not contain all possible drug interactions.||
5179|117|I|Keep a list of all the products you use (including||
5179|118|I|prescription/nonprescription drugs and herbal products) and share||
5179|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
5179|120|I|the dosage of any medicines without your doctor's approval.||
5179|121|I|   Some products that may interact with this drug include:||
5179|122|I|anti-cancer drugs (such as mechlorethamine, nitrogen mustard),||
5179|123|I|azole antifungals (such as ketoconazole, itraconazole),||
5179|124|I|cidofovir, digoxin, flucytosine, medications that affect the||
5179|125|I|kidneys (including pentamidine, tacrolimus, aminoglycosides such||
5179|126|I|as gentamicin), muscle relaxants (such as tubocurarine),||
5179|127|I|zidovudine.||
5179|128|B|||
5179|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5179|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5179|131|O|poison control center right away. US residents can call||
5179|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5179|133|O|Symptoms of overdose may include: dizziness, fainting, slow||
5179|134|O|heartbeat, trouble breathing.||
5179|135|B|||
5179|136|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
5179|137|N|potassium/magnesium levels, complete blood counts) should be done||
5179|138|N|while you are using this medication. Keep all medical and lab||
5179|139|N|appointments. Consult your doctor for more details.||
5179|140|B|||
5179|141|D|MISSED DOSE:  It is important to get each dose of this medication||
5179|142|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
5179|143|D|right away for a new dosing schedule. Do not double the dose to||
5179|144|D|catch up.||
5179|145|B|||
5179|146|R|STORAGE:  Consult the product instructions and your pharmacist||
5179|147|R|for storage details. Keep all medications away from children and||
5179|148|R|pets.||
5179|149|R|   Do not flush medications down the toilet or pour them into a||
5179|150|R|drain unless instructed to do so. Properly discard this product||
5179|151|R|when it is expired or no longer needed. Consult your pharmacist||
5179|152|R|or local waste disposal company.||
5179|153|B|||
5179|154|A|Information last revised May 2025.||
5179|155|A|Copyright(c) 2025 First Databank, Inc.||
5179|156|B|||
5181|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5181|002|Z|does NOT have all possible information about this product. This||
5181|003|Z|information does not assure that this product is safe, effective,||
5181|004|Z|or appropriate for you. This information is not individual||
5181|005|Z|medical advice and does not substitute for the advice of your||
5181|006|Z|health care professional. Always ask your health care||
5181|007|Z|professional for complete information about this product and your||
5181|008|Z|specific health needs.||
5181|009|B|||
5181|010|T|ERYTHROMYCIN GEL - TOPICAL||
5181|011|F|(eh-rith-row-MY-sin)||
5181|012|B|||
5181|013|C|COMMON BRAND NAME(S): A/T/S, Emgel, Erygel||
5181|014|B|||
5181|015|U|USES:  This medication is used to treat acne. It helps to reduce||
5181|016|U|the number of pimples. Erythromycin is an antibiotic||
5181|017|U|(macrolide-type). It works by stopping the growth of bacteria.||
5181|018|U|This product contains a large amount of alcohol which dries extra||
5181|019|U|oils from the skin.||
5181|020|B|||
5181|021|H|HOW TO USE:  This medication is for use on the skin only. Clean||
5181|022|H|and dry the affected area as directed. Then apply a thin layer of||
5181|023|H|the medication on the skin as directed by your doctor, usually||
5181|024|H|once or twice a day. Wash your hands after use.||
5181|025|H|   Do not use large amounts or apply this more often or for a||
5181|026|H|longer period than directed. Your condition will not clear||
5181|027|H|faster, but the risk of side effects may be increased.||
5181|028|H|   Use this medication regularly in order to get the most benefit||
5181|029|H|from it. Remember to use it at the same time(s) each day.||
5181|030|H|   Avoid getting this medication in your eyes or inside the nose||
5181|031|H|or mouth. If this occurs, rinse thoroughly with water.||
5181|032|H|   Tell your doctor if your condition does not get better or if||
5181|033|H|it gets worse. It may take up to 3 months of regular use before||
5181|034|H|the full benefits of this medication take effect.||
5181|035|B|||
5181|036|S|SIDE EFFECTS:  Burning, redness, itching, or dry/peeling/oily||
5181|037|S|skin may occur, especially in the first few days as your body||
5181|038|S|adjusts to the medication. Eye irritation may also occur. If any||
5181|039|S|of these effects last or get worse, tell your doctor or||
5181|040|S|pharmacist promptly.||
5181|041|S|   Remember that this medication has been prescribed because your||
5181|042|S|doctor has judged that the benefit to you is greater than the||
5181|043|S|risk of side effects. Many people using this medication do not||
5181|044|S|have serious side effects.||
5181|045|S|   Rarely, use of this medication may result in other types of||
5181|046|S|skin infections (fungal or other bacterial infections). Contact||
5181|047|S|your doctor if you notice any unusual skin irritation or other||
5181|048|S|symptoms.||
5181|049|S|   A very serious allergic reaction to this drug is rare.||
5181|050|S|However, get medical help right away if you notice any symptoms||
5181|051|S|of a serious allergic reaction, including: rash, itching/swelling||
5181|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5181|053|S|breathing.||
5181|054|S|   This is not a complete list of possible side effects. If you||
5181|055|S|notice other effects not listed above, contact your doctor or||
5181|056|S|pharmacist.||
5181|057|S|   In the US -||
5181|058|S|   Call your doctor for medical advice about side effects. You||
5181|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5181|060|S|www.fda.gov/medwatch.||
5181|061|S|   In Canada - Call your doctor for medical advice about side||
5181|062|S|effects. You may report side effects to Health Canada at||
5181|063|S|1-866-234-2345.||
5181|064|B|||
5181|065|P|PRECAUTIONS:  Before using erythromycin, tell your doctor or||
5181|066|P|pharmacist if you are allergic to it; or to other antibiotics||
5181|067|P|(such as azithromycin, clarithromycin); or if you have any other||
5181|068|P|allergies. This product may contain inactive ingredients, which||
5181|069|P|can cause allergic reactions or other problems. Talk to your||
5181|070|P|pharmacist for more details.||
5181|071|P|   Before using this medication, tell your doctor or pharmacist||
5181|072|P|your medical history.||
5181|073|P|   During pregnancy, this medication should be used only when||
5181|074|P|clearly needed. Discuss the risks and benefits with your doctor.||
5181|075|P|   It is unknown if this medication passes into breast milk.||
5181|076|P|Consult your doctor before breastfeeding.||
5181|077|B|||
5181|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5181|079|I|medications work or increase your risk for serious side effects.||
5181|080|I|This document does not contain all possible drug interactions.||
5181|081|I|Keep a list of all the products you use (including||
5181|082|I|prescription/nonprescription drugs and herbal products) and share||
5181|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
5181|084|I|the dosage of any medicines without your doctor's approval.||
5181|085|I|   A product that may interact with this drug is: disulfiram.||
5181|086|B|||
5181|087|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5181|088|O|has overdosed and has serious symptoms such as passing out or||
5181|089|O|trouble breathing, call 911. Otherwise, call a poison control||
5181|090|O|center right away. US residents can call 1-800-222-1222. Canada||
5181|091|O|residents can call 1-844-764-7669.||
5181|092|B|||
5181|093|N|NOTES:  Do not share this medication with others.||
5181|094|N|   For the best results, this medication is often used as part of||
5181|095|N|a total skin care program. Follow your doctor's recommendations.||
5181|096|B|||
5181|097|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5181|098|D|If it is near the time of the next dose, skip the missed dose.||
5181|099|D|Use your next dose at the regular time. Do not double the dose to||
5181|100|D|catch up.||
5181|101|B|||
5181|102|R|STORAGE:  Store at room temperature. This medication is||
5181|103|R|flammable. Keep it away from heat and open flame. Keep all||
5181|104|R|medications away from children and pets.||
5181|105|R|   Do not flush medications down the toilet or pour them into a||
5181|106|R|drain unless instructed to do so. Properly discard this product||
5181|107|R|when it is expired or no longer needed. Consult your pharmacist||
5181|108|R|or local waste disposal company.||
5181|109|B|||
5181|110|A|Information last revised July 2025.||
5181|111|A|Copyright(c) 2025 First Databank, Inc.||
5181|112|B|||
5185|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5185|002|Z|does NOT have all possible information about this product. This||
5185|003|Z|information does not assure that this product is safe, effective,||
5185|004|Z|or appropriate for you. This information is not individual||
5185|005|Z|medical advice and does not substitute for the advice of your||
5185|006|Z|health care professional. Always ask your health care||
5185|007|Z|professional for complete information about this product and your||
5185|008|Z|specific health needs.||
5185|009|B|||
5185|010|T|HYDROCORTISONE ENEMA - RECTAL||
5185|011|F|(HYE-droe-KOR-ti-sone)||
5185|012|B|||
5185|013|C|COMMON BRAND NAME(S): Cortenema||
5185|014|B|||
5185|015|U|USES:  This medication is used to treat the symptoms of a certain||
5185|016|U|intestinal problem called ulcerative colitis. It is not a cure||
5185|017|U|for this condition, but it is usually used with other treatments||
5185|018|U|to manage this problem. Hydrocortisone enemas help to decrease||
5185|019|U|diarrhea and bloody stools by reducing swelling (inflammation) in||
5185|020|U|the rectum and colon. Hydrocortisone belongs to a class of drugs||
5185|021|U|called corticosteroids.||
5185|022|B|||
5185|023|H|HOW TO USE:  Read the directions for use that come with this||
5185|024|H|product. If you have any questions, ask your doctor or||
5185|025|H|pharmacist.||
5185|026|H|   Use this product in the rectum as directed by your doctor,||
5185|027|H|usually once nightly before bedtime. The usual length of||
5185|028|H|treatment is 2 to 3 weeks or until symptoms go away (remission).||
5185|029|H|In some cases, remission may take up to 2 or 3 months. The dosage||
5185|030|H|and length of treatment are based on your medical condition and||
5185|031|H|response to treatment.||
5185|032|H|   For best results, use after a bowel movement. Shake the bottle||
5185|033|H|thoroughly before use. Lie on your left side with your right knee||
5185|034|H|bent toward the chest. Gently insert the applicator tip into the||
5185|035|H|rectum. Gently but firmly squeeze the bottle so that all of the||
5185|036|H|drug flows into the rectum. Remain lying on your left side for at||
5185|037|H|least 30 minutes. Keep the medicine in your rectum for at least 1||
5185|038|H|hour and overnight if possible.||
5185|039|H|   Use this medication regularly as prescribed to get the most||
5185|040|H|benefit from it. It may take 3 to 5 days to notice an||
5185|041|H|improvement.||
5185|042|H|   Do not use more of this product, use it more often, or use it||
5185|043|H|for longer than prescribed. Your condition will not improve any||
5185|044|H|faster, and your risk of side effects may increase. If you have||
5185|045|H|been using this medication for a long time (more than 3 weeks),||
5185|046|H|do not stop using it without consulting your doctor. Some||
5185|047|H|conditions may become worse when this drug is suddenly stopped.||
5185|048|H|Your dose may need to be gradually decreased.||
5185|049|H|   Tell your doctor if your condition does not get better after 2||
5185|050|H|to 3 weeks of treatment or if it gets worse.||
5185|051|B|||
5185|052|S|SIDE EFFECTS:  Pain or burning in the rectum, dizziness,||
5185|053|S|menstrual period changes, trouble sleeping, unusual weight gain,||
5185|054|S|increased sweating, acne, or unusual hair growth may occur. If||
5185|055|S|any of these effects last or get worse, tell your doctor or||
5185|056|S|pharmacist promptly.||
5185|057|S|   Remember that this medication has been prescribed because your||
5185|058|S|doctor has judged that the benefit to you is greater than the||
5185|059|S|risk of side effects. Many people using this medication do not||
5185|060|S|have serious side effects.||
5185|061|S|   Tell your doctor right away if you have any serious side||
5185|062|S|effects, including: rectal bleeding that doesn't stop, headache||
5185|063|S|that doesn't go away, swelling ankles/feet, increased||
5185|064|S|thirst/urination, vision problems, puffy face, thinning skin,||
5185|065|S|unusual skin growths, slow wound healing, unusual||
5185|066|S|bruising/bleeding, symptoms of stomach/intestinal bleeding (such||
5185|067|S|as stomach/abdominal pain, black/tarry stools, vomit that looks||
5185|068|S|like coffee grounds), severe heartburn, bone pain, easily broken||
5185|069|S|bones, mental/mood changes (such as depression, mood swings,||
5185|070|S|agitation), muscle weakness/pain, irregular heartbeat, signs of||
5185|071|S|infection (such as sore throat that doesn't go away, fever,||
5185|072|S|chills, painful urination, worsening redness/irritation near the||
5185|073|S|anus), seizures.||
5185|074|S|   A very serious allergic reaction to this drug is rare.||
5185|075|S|However, get medical help right away if you notice any symptoms||
5185|076|S|of a serious allergic reaction, including: rash, itching/swelling||
5185|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5185|078|S|breathing.||
5185|079|S|   This is not a complete list of possible side effects. If you||
5185|080|S|notice other effects not listed above, contact your doctor or||
5185|081|S|pharmacist.||
5185|082|S|   In the US -||
5185|083|S|   Call your doctor for medical advice about side effects. You||
5185|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5185|085|S|www.fda.gov/medwatch.||
5185|086|S|   In Canada - Call your doctor for medical advice about side||
5185|087|S|effects. You may report side effects to Health Canada at||
5185|088|S|1-866-234-2345.||
5185|089|B|||
5185|090|P|PRECAUTIONS:  Before using hydrocortisone, tell your doctor or||
5185|091|P|pharmacist if you are allergic to it; or to other corticosteroids||
5185|092|P|(such as prednisone); or if you have any other allergies. This||
5185|093|P|product may contain inactive ingredients, which can cause||
5185|094|P|allergic reactions or other problems. Talk to your pharmacist for||
5185|095|P|more details.||
5185|096|P|   Before using this medication, tell your doctor or pharmacist||
5185|097|P|your medical history, especially of: other stomach/intestinal||
5185|098|P|problems (such as ulcers, blockage, bleeding, infection, recent||
5185|099|P|surgery), infections (such as tuberculosis, fungal infections),||
5185|100|P|certain eye conditions (cataracts, glaucoma, herpes infection of||
5185|101|P|the eye), heart problems (such as heart failure, recent heart||
5185|102|P|attack), high blood pressure, liver disease, kidney disease,||
5185|103|P|thyroid problems (overactive or underactive thyroid disease),||
5185|104|P|diabetes, bone loss (osteoporosis), bleeding or blood clotting||
5185|105|P|problems, mental/mood conditions (such as psychosis, depression),||
5185|106|P|low potassium or calcium blood levels, a certain muscle/nerve||
5185|107|P|disease (myasthenia gravis).||
5185|108|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5185|109|P|can make you more dizzy. Do not drive, use machinery, or do||
5185|110|P|anything that needs alertness until you can do it safely. Limit||
5185|111|P|alcoholic beverages to also decrease the risk of||
5185|112|P|stomach/intestinal bleeding. Talk to your doctor if you are using||
5185|113|P|marijuana (cannabis).||
5185|114|P|   Using corticosteroid medications for a long time can make it||
5185|115|P|more difficult for your body to respond to physical stress.||
5185|116|P|Before having surgery or emergency treatment, or if you get a||
5185|117|P|serious illness/injury, tell your doctor or dentist that you are||
5185|118|P|using this medication or have used this medication within the||
5185|119|P|past 12 months. Tell your doctor right away if you develop||
5185|120|P|unusual/extreme tiredness or weight loss. If you will be using||
5185|121|P|this medication for a long time, carry a warning card or medical||
5185|122|P|ID bracelet that identifies your use of this medication.||
5185|123|P|   Tell your health care professional that you are using||
5185|124|P|hydrocortisone before having any immunizations, vaccinations, or||
5185|125|P|skin tests. Avoid contact with people who have recently received||
5185|126|P|live vaccines (such as flu vaccine inhaled through the nose).||
5185|127|P|   This drug can make you more likely to get infections or may||
5185|128|P|make current infections worse. Stay away from anyone who has an||
5185|129|P|infection that may easily spread (such as chickenpox, COVID-19,||
5185|130|P|measles, flu). Talk to your doctor if you have been exposed to an||
5185|131|P|infection or for more details.||
5185|132|P|   If you have diabetes, this drug may affect your blood sugar.||
5185|133|P|Check your blood sugar regularly as directed and share the||
5185|134|P|results with your doctor. Tell your doctor right away if you have||
5185|135|P|symptoms of high blood sugar such as increased thirst/urination.||
5185|136|P|Your doctor may need to adjust your diabetes medication, exercise||
5185|137|P|program, or diet.||
5185|138|P|   Older adults may be more sensitive to the side effects of this||
5185|139|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
5185|140|P|mental/mood changes (such as confusion).||
5185|141|P|   This medication may slow down a child's growth if used for a||
5185|142|P|long time. Consult the doctor or pharmacist for more details. See||
5185|143|P|the doctor regularly so your child's height and growth can be||
5185|144|P|checked.||
5185|145|P|   During pregnancy, this medication should be used only when||
5185|146|P|clearly needed and not for prolonged periods. Other forms of||
5185|147|P|hydrocortisone (given by mouth or by injection) may harm an||
5185|148|P|unborn baby. Discuss the risks and benefits with your doctor.||
5185|149|P|Infants born to mothers who have been using this medication for||
5185|150|P|an extended time may have low levels of the natural||
5185|151|P|corticosteroid hormone in their bodies and may need more||
5185|152|P|monitoring. Tell your doctor right away if you notice symptoms||
5185|153|P|such as vomiting, severe diarrhea, or weakness in your newborn.||
5185|154|P|   It is unknown if this drug passes into breast milk. However,||
5185|155|P|it is unlikely to harm a nursing infant. Consult your doctor||
5185|156|P|before breastfeeding.||
5185|157|B|||
5185|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5185|159|I|medications work or increase your risk for serious side effects.||
5185|160|I|This document does not contain all possible drug interactions.||
5185|161|I|Keep a list of all the products you use (including||
5185|162|I|prescription/nonprescription drugs and herbal products) and share||
5185|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
5185|164|I|the dosage of any medicines without your doctor's approval.||
5185|165|I|   Some products that may interact with this drug include:||
5185|166|I|aldesleukin, "blood thinners" (such as warfarin), desmopressin.||
5185|167|I|   Check all prescription and nonprescription medicine labels||
5185|168|I|carefully since many medications contain pain relievers/fever||
5185|169|I|reducers (including aspirin, salicylates, NSAIDs such as||
5185|170|I|ibuprofen, naproxen) that may increase your risk of bleeding when||
5185|171|I|taken with corticosteroids. However, if your doctor has told you||
5185|172|I|to take low-dose aspirin to prevent heart attack or stroke||
5185|173|I|(usually 81-162 milligrams a day), you should keep taking the||
5185|174|I|aspirin unless your doctor tells you not to. Ask your doctor or||
5185|175|I|pharmacist for more details.||
5185|176|B|||
5185|177|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5185|178|O|has overdosed and has serious symptoms such as passing out or||
5185|179|O|trouble breathing, call 911. Otherwise, call a poison control||
5185|180|O|center right away. US residents can call 1-800-222-1222. Canada||
5185|181|O|residents can call 1-844-764-7669.||
5185|182|B|||
5185|183|N|NOTES:  Do not share this medication with others.||
5185|184|N|   Lab and/or medical tests (such as sigmoidoscopy, colonoscopy,||
5185|185|N|adrenal gland function) should be done while you are using this||
5185|186|N|medication. Keep all medical and lab appointments. Consult your||
5185|187|N|doctor for more details.||
5185|188|N|   If you use this medication for a long time, wear or carry||
5185|189|N|identification stating that you are using it.||
5185|190|B|||
5185|191|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5185|192|D|If it is near the time of the next dose, skip the missed dose.||
5185|193|D|Use your next dose at the regular time. Do not double the dose to||
5185|194|D|catch up.||
5185|195|B|||
5185|196|R|STORAGE:  Store at room temperature. Keep all medications away||
5185|197|R|from children and pets.||
5185|198|R|   Do not flush medications down the toilet or pour them into a||
5185|199|R|drain unless instructed to do so. Properly discard this product||
5185|200|R|when it is expired or no longer needed. Consult your pharmacist||
5185|201|R|or local waste disposal company.||
5185|202|B|||
5185|203|A|Information last revised May 2025.||
5185|204|A|Copyright(c) 2025 First Databank, Inc.||
5185|205|B|||
5186|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5186|002|Z|does NOT have all possible information about this product. This||
5186|003|Z|information does not assure that this product is safe, effective,||
5186|004|Z|or appropriate for you. This information is not individual||
5186|005|Z|medical advice and does not substitute for the advice of your||
5186|006|Z|health care professional. Always ask your health care||
5186|007|Z|professional for complete information about this product and your||
5186|008|Z|specific health needs.||
5186|009|B|||
5186|010|T|INDOMETHACIN - ORAL||
5186|011|F|(in-doh-METH-uh-sin)||
5186|012|B|||
5186|013|C|COMMON BRAND NAME(S): Indocin||
5186|014|B|||
5186|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
5186|016|W|indomethacin) may rarely increase the risk for a heart attack or||
5186|017|W|stroke. This effect can happen at any time while taking this drug||
5186|018|W|but is more likely if you take it for a long time. The risk may||
5186|019|W|be greater in older adults or if you have heart disease or||
5186|020|W|increased risk for heart disease (for example, due to smoking,||
5186|021|W|family history of heart disease, or conditions such as high blood||
5186|022|W|pressure or diabetes). Do not take this drug right before or||
5186|023|W|after heart bypass surgery (CABG).||
5186|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
5186|025|W|bleeding from the stomach or intestines. This effect can occur||
5186|026|W|without warning symptoms at any time while taking this drug.||
5186|027|W|Older adults may be at higher risk for this effect. (See also||
5186|028|W|Precautions and Drug Interactions sections.)||
5186|029|W|   Stop taking indomethacin and get medical help right away if||
5186|030|W|you notice any of the following rare but serious side effects:||
5186|031|W|stomach/abdominal pain that doesn't go away, bloody or||
5186|032|W|black/tarry stools, vomit that looks like coffee grounds,||
5186|033|W|chest/jaw/left arm pain, shortness of breath, unusual sweating,||
5186|034|W|weakness on one side of the body, sudden vision changes, trouble||
5186|035|W|speaking.||
5186|036|W|   Talk with your doctor or pharmacist about the risks and||
5186|037|W|benefits of treatment with this medication.||
5186|038|B|||
5186|039|U|USES:  Indomethacin is used to relieve pain, swelling, and joint||
5186|040|U|stiffness caused by arthritis, gout, bursitis, and tendonitis. It||
5186|041|U|is also used to relieve pain from various other conditions. This||
5186|042|U|medication is known as a nonsteroidal anti-inflammatory drug||
5186|043|U|(NSAID). It works by blocking your body's production of certain||
5186|044|U|natural substances that cause inflammation. This effect helps to||
5186|045|U|decrease swelling and pain.||
5186|046|U|   If you are treating a chronic condition such as arthritis, ask||
5186|047|U|your doctor about non-drug treatments and/or using other||
5186|048|U|medications to treat your pain. See also Warning section.||
5186|049|B|||
5186|050|V|OTHER USES:  This section contains uses of this drug that are not||
5186|051|V|listed in the approved professional labeling for the drug but||
5186|052|V|that may be prescribed by your health care professional. Use this||
5186|053|V|drug for a condition that is listed in this section only if it||
5186|054|V|has been so prescribed by your health care professional.||
5186|055|V|   This medication may also be used to relieve pain caused by||
5186|056|V|inflammation of the pouch surrounding the heart and other||
5186|057|V|conditions, as prescribed by your doctor.||
5186|058|B|||
5186|059|H|HOW TO USE:  Read the Medication Guide provided by your||
5186|060|H|pharmacist before you start using indomethacin and each time you||
5186|061|H|get a refill. If you have any questions, ask your doctor or||
5186|062|H|pharmacist.||
5186|063|H|   Take this medication by mouth as directed by your doctor,||
5186|064|H|usually 2 to 3 times a day with a full glass of water (8 ounces||
5186|065|H|or 240 milliliters). Do not lie down for at least 10 minutes||
5186|066|H|after taking this drug. If stomach upset occurs while taking this||
5186|067|H|medication, take it with food, milk, or an antacid.||
5186|068|H|   The dosage is based on your medical condition and response to||
5186|069|H|treatment. Children's dosage is also based on weight. To reduce||
5186|070|H|your risk of stomach bleeding and other side effects, take this||
5186|071|H|medication at the lowest effective dose for the shortest possible||
5186|072|H|time. Do not increase your dose or use this drug more often or||
5186|073|H|for longer than prescribed. For ongoing conditions such as||
5186|074|H|arthritis, keep taking this medication as directed. Discuss the||
5186|075|H|risks and benefits with your doctor or pharmacist.||
5186|076|H|   In certain conditions (such as arthritis), it may take up to 4||
5186|077|H|weeks when this drug is taken regularly before you notice the||
5186|078|H|full benefits.||
5186|079|H|   If you are taking this drug on an "as needed" basis (not on a||
5186|080|H|regular schedule), remember that pain medications work best if||
5186|081|H|they are used as the first signs of pain occur. If you wait until||
5186|082|H|the pain has worsened, the medication may not work as well.||
5186|083|H|   Tell your doctor if your condition gets worse.||
5186|084|B|||
5186|085|S|SIDE EFFECTS:  See also Warning section.||
5186|086|S|   Upset stomach, heartburn, headache, drowsiness, or dizziness||
5186|087|S|may occur. If any of these effects last or get worse, tell your||
5186|088|S|doctor or pharmacist promptly.||
5186|089|S|   Remember that this medication has been prescribed because your||
5186|090|S|doctor has judged that the benefit to you is greater than the||
5186|091|S|risk of side effects. Many people using this medication do not||
5186|092|S|have serious side effects.||
5186|093|S|   This medication may raise your blood pressure. Check your||
5186|094|S|blood pressure regularly and tell your doctor if the results are||
5186|095|S|high.||
5186|096|S|   Tell your doctor right away if you have any serious side||
5186|097|S|effects, including: hearing changes (such as ringing in the||
5186|098|S|ears), mental/mood changes (such as confusion, hallucinations),||
5186|099|S|difficult/painful swallowing, signs of kidney problems (such as||
5186|100|S|change in the amount of urine), symptoms of heart failure (such||
5186|101|S|as swelling ankles/feet, unusual tiredness, unusual/sudden weight||
5186|102|S|gain).||
5186|103|S|   This drug may rarely cause serious (possibly fatal) liver||
5186|104|S|disease. Get medical help right away if you have any symptoms of||
5186|105|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
5186|106|S|of appetite, dark urine, severe stomach/abdominal pain, yellowing||
5186|107|S|eyes/skin.||
5186|108|S|   A very serious allergic reaction to this drug is rare.||
5186|109|S|However, get medical help right away if you notice any symptoms||
5186|110|S|of a serious allergic reaction, including: fever, swollen lymph||
5186|111|S|nodes, rash, itching/swelling (especially of the||
5186|112|S|face/tongue/throat), severe dizziness, trouble breathing.||
5186|113|S|   This is not a complete list of possible side effects. If you||
5186|114|S|notice other effects not listed above, contact your doctor or||
5186|115|S|pharmacist.||
5186|116|S|   In the US -||
5186|117|S|   Call your doctor for medical advice about side effects. You||
5186|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5186|119|S|www.fda.gov/medwatch.||
5186|120|S|   In Canada - Call your doctor for medical advice about side||
5186|121|S|effects. You may report side effects to Health Canada at||
5186|122|S|1-866-234-2345.||
5186|123|B|||
5186|124|P|PRECAUTIONS:  Before taking indomethacin, tell your doctor or||
5186|125|P|pharmacist if you are allergic to it; or to aspirin or other||
5186|126|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
5186|127|P|any other allergies. This product may contain inactive||
5186|128|P|ingredients, which can cause allergic reactions or other||
5186|129|P|problems. Talk to your pharmacist for more details.||
5186|130|P|   Before using this medication, tell your doctor or pharmacist||
5186|131|P|your medical history, especially of: asthma (including a history||
5186|132|P|of worsening breathing after taking aspirin or other NSAIDs),||
5186|133|P|bleeding or clotting problems, growths in the nose (nasal||
5186|134|P|polyps), heart disease (such as previous heart attack), high||
5186|135|P|blood pressure, liver disease, stomach/intestinal/esophagus||
5186|136|P|problems (such as bleeding, ulcers, recurring heartburn), stroke.||
5186|137|P|   Kidney problems can sometimes occur with the use of NSAID||
5186|138|P|medications, including indomethacin. Problems are more likely to||
5186|139|P|occur if you are dehydrated, have heart failure or kidney||
5186|140|P|disease, are an older adult, or if you take certain medications||
5186|141|P|(see also Drug Interactions section). Drink plenty of fluids as||
5186|142|P|directed by your doctor to prevent dehydration and tell your||
5186|143|P|doctor right away if you have a change in the amount of urine.||
5186|144|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5186|145|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5186|146|P|machinery, or do anything that needs alertness until you can do||
5186|147|P|it safely. Talk to your doctor if you are using marijuana||
5186|148|P|(cannabis).||
5186|149|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
5186|150|P|and tobacco, especially when combined with this medicine, may||
5186|151|P|increase your risk for stomach bleeding. Limit alcohol and stop||
5186|152|P|smoking. Consult your doctor or pharmacist for more information.||
5186|153|P|   Before having surgery, tell your doctor or dentist about all||
5186|154|P|the products you use (including prescription drugs,||
5186|155|P|nonprescription drugs, and herbal products).||
5186|156|P|   This medication may make you more sensitive to the sun. Limit||
5186|157|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5186|158|P|sunscreen and wear protective clothing when outdoors. Tell your||
5186|159|P|doctor right away if you get sunburned or have skin||
5186|160|P|blisters/redness.||
5186|161|P|   Older adults may be at greater risk for stomach/intestinal||
5186|162|P|bleeding, kidney problems, heart attack, stroke, and mental/mood||
5186|163|P|changes while using this drug.||
5186|164|P|   Children may be more sensitive to the side effects of this||
5186|165|P|drug, especially serious liver problems. Caution is advised when||
5186|166|P|this drug is used by children. Discuss the risks and benefits of||
5186|167|P|treatment with your doctor.||
5186|168|P|   Before using this medication, women of childbearing age should||
5186|169|P|talk with their doctor(s) about the benefits and risks. Tell your||
5186|170|P|doctor if you are pregnant or if you plan to become pregnant.||
5186|171|P|This medication may harm an unborn baby and cause problems with||
5186|172|P|normal labor/delivery. It is not recommended for use in pregnancy||
5186|173|P|from 20 weeks until delivery. If your doctor decides that you||
5186|174|P|need to use this medication between 20 and 30 weeks of pregnancy,||
5186|175|P|you should use the lowest effective dose for the shortest||
5186|176|P|possible time. You should not use this medication after 30 weeks||
5186|177|P|of pregnancy.||
5186|178|P|   This drug passes into breast milk and may have undesirable||
5186|179|P|effects on a nursing infant. Consult your doctor before||
5186|180|P|breastfeeding.||
5186|181|B|||
5186|182|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5186|183|I|medications work or increase your risk for serious side effects.||
5186|184|I|This document does not contain all possible drug interactions.||
5186|185|I|Keep a list of all the products you use (including||
5186|186|I|prescription/nonprescription drugs and herbal products) and share||
5186|187|I|it with your doctor and pharmacist. Do not start, stop, or change||
5186|188|I|the dosage of any medicines without your doctor's approval.||
5186|189|I|   Some products that may interact with this drug include:||
5186|190|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
5186|191|I|angiotensin II receptor blockers (such as valsartan, losartan),||
5186|192|I|cidofovir, corticosteroids (such as prednisone), lithium,||
5186|193|I|methotrexate, "water pills" (diuretics such as furosemide).||
5186|194|I|   This medication may increase the risk of bleeding when taken||
5186|195|I|with other drugs that also may cause bleeding. Examples include||
5186|196|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
5186|197|I|dabigatran/enoxaparin/warfarin, among others.||
5186|198|I|   Check all prescription and nonprescription medicine labels||
5186|199|I|carefully since many medications contain pain relievers/fever||
5186|200|I|reducers (aspirin, NSAIDs such as celecoxib, diflunisal,||
5186|201|I|ibuprofen, or ketorolac). These drugs are similar to indomethacin||
5186|202|I|and may increase your risk of side effects if taken together.||
5186|203|I|However, if your doctor has told you to take low-dose aspirin to||
5186|204|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
5186|205|I|you should keep taking the aspirin unless your doctor tells you||
5186|206|I|not to. Ask your doctor or pharmacist for more details.||
5186|207|I|   This medication may interfere with certain lab tests, possibly||
5186|208|I|causing false test results. Make sure lab personnel and all your||
5186|209|I|doctors know you use this drug.||
5186|210|B|||
5186|211|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5186|212|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5186|213|O|poison control center right away. US residents can call||
5186|214|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5186|215|O|Symptoms of overdose may include: severe stomach pain, vomit that||
5186|216|O|looks like coffee grounds, extreme drowsiness, slow or shallow||
5186|217|O|breathing, confusion, seizures.||
5186|218|B|||
5186|219|N|NOTES:  Do not share this medication with others.||
5186|220|N|   Lab and/or medical tests (such as blood pressure, complete||
5186|221|N|blood count, liver/kidney function) may be done while you are||
5186|222|N|taking this medication. Keep all medical and lab appointments.||
5186|223|N|Consult your doctor for more details.||
5186|224|N|   Non-drug treatment for arthritis that is approved by your||
5186|225|N|doctor (such as weight loss if needed, strengthening and||
5186|226|N|conditioning exercises) may help improve your flexibility, range||
5186|227|N|of motion, and joint function. Consult your doctor for specific||
5186|228|N|instructions.||
5186|229|B|||
5186|230|D|MISSED DOSE:  If you are prescribed this drug on a regular||
5186|231|D|schedule (not just "as needed") and you miss a dose, take it as||
5186|232|D|soon as you remember. If it is near the time of the next dose,||
5186|233|D|skip the missed dose. Take your next dose at the regular time. Do||
5186|234|D|not double the dose to catch up.||
5186|235|B|||
5186|236|R|STORAGE:  Store at room temperature away from light and moisture.||
5186|237|R|Do not store in the bathroom. Keep all medications away from||
5186|238|R|children and pets.||
5186|239|R|   Do not flush medications down the toilet or pour them into a||
5186|240|R|drain unless instructed to do so. Properly discard this product||
5186|241|R|when it is expired or no longer needed. Consult your pharmacist||
5186|242|R|or local waste disposal company.||
5186|243|B|||
5186|244|A|Information last revised May 2025.||
5186|245|A|Copyright(c) 2025 First Databank, Inc.||
5186|246|B|||
5194|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5194|002|Z|does NOT have all possible information about this product. This||
5194|003|Z|information does not assure that this product is safe, effective,||
5194|004|Z|or appropriate for you. This information is not individual||
5194|005|Z|medical advice and does not substitute for the advice of your||
5194|006|Z|health care professional. Always ask your health care||
5194|007|Z|professional for complete information about this product and your||
5194|008|Z|specific health needs.||
5194|009|B|||
5194|010|T|MEPERIDINE - ORAL||
5194|011|F|(me-PER-i-deen)||
5194|012|B|||
5194|013|C|COMMON BRAND NAME(S): Demerol||
5194|014|B|||
5194|015|W|WARNING:  Meperidine has a risk for abuse and addiction, which||
5194|016|W|can lead to overdose and death. Meperidine may also cause severe,||
5194|017|W|possibly fatal, breathing problems. To lower your risk, your||
5194|018|W|doctor should have you take the smallest dose of meperidine that||
5194|019|W|works, and take it for the shortest possible time. See also How||
5194|020|W|to Use section for more information about addiction.||
5194|021|W|   Ask your doctor or pharmacist if you should have medication||
5194|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
5194|023|W|Teach your family or household members about the signs of an||
5194|024|W|opioid overdose and how to treat it.||
5194|025|W|   The risk for severe breathing problems is higher when you||
5194|026|W|start this medication and after a dose increase, or if you take||
5194|027|W|the wrong dose/strength. Taking this medication with alcohol or||
5194|028|W|other drugs that can cause drowsiness or breathing problems may||
5194|029|W|cause very serious side effects, including death. Also, other||
5194|030|W|medications can affect the removal of meperidine from your body,||
5194|031|W|which may affect how meperidine works. Be sure you know how to||
5194|032|W|take meperidine and what other drugs you should avoid taking with||
5194|033|W|it. See also Drug Interactions section. Get medical help right||
5194|034|W|away if any of these very serious side effects occur:||
5194|035|W|slow/shallow breathing, unusual lightheadedness, severe||
5194|036|W|drowsiness/dizziness, difficulty waking up.||
5194|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
5194|038|W|or abuse. If someone accidentally swallows this drug, get medical||
5194|039|W|help right away.||
5194|040|W|   Before using this medication, women of childbearing age should||
5194|041|W|talk with their doctor(s) about the risks and benefits. Tell your||
5194|042|W|doctor if you are pregnant or if you plan to become pregnant.||
5194|043|W|During pregnancy, this medication should be used only when||
5194|044|W|clearly needed. It may slightly increase the risk of birth||
5194|045|W|defects if used during the first two months of pregnancy. Also,||
5194|046|W|using it for a long time or in high doses near the expected||
5194|047|W|delivery date may harm the unborn baby. To lessen the risk, take||
5194|048|W|the smallest effective dose for the shortest possible time.||
5194|049|W|Babies born to mothers who use this drug for a long time may||
5194|050|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
5194|051|W|doctor right away if you notice any symptoms in your newborn baby||
5194|052|W|such as crying that doesn't stop, slow/shallow breathing,||
5194|053|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
5194|054|W|difficulty gaining weight.||
5194|055|B|||
5194|056|U|USES:  Meperidine is used to help relieve moderate to severe||
5194|057|U|pain. It belongs to a class of drugs known as opioid analgesics||
5194|058|U|and is similar to morphine. It works in the brain to change how||
5194|059|U|your body feels and responds to pain.||
5194|060|U|   Meperidine should not be used to treat long-term or ongoing||
5194|061|U|pain. It should only be used to treat sudden episodes of moderate||
5194|062|U|to severe pain. See also Precautions section.||
5194|063|U|   This drug is not recommended for use in newborns due to an||
5194|064|U|increased risk of serious side effects. Ask the doctor or||
5194|065|U|pharmacist for details.||
5194|066|B|||
5194|067|H|HOW TO USE:  Read the Medication Guide provided by your||
5194|068|H|pharmacist before you start taking meperidine and each time you||
5194|069|H|get a refill. If you have any questions, ask your doctor or||
5194|070|H|pharmacist.||
5194|071|H|   Take this medication by mouth as directed by your doctor,||
5194|072|H|usually every 3 to 4 hours as needed. You may take this drug with||
5194|073|H|or without food. If you have nausea, it may help to take this||
5194|074|H|drug with food. Ask your doctor or pharmacist about other ways to||
5194|075|H|decrease nausea (such as lying down for 1 to 2 hours with as||
5194|076|H|little head movement as possible).||
5194|077|H|   If you are using the liquid form of this medication, carefully||
5194|078|H|measure the dose using a special measuring device/spoon. Do not||
5194|079|H|use a household spoon because you may not get the correct dose.||
5194|080|H|Make sure not to confuse the dose of meperidine liquid in||
5194|081|H|milligrams (mg) with the dose in milliliters (mL). Ask your||
5194|082|H|pharmacist or doctor to show you the right way to measure your||
5194|083|H|dose. Mix your dose with one-half glass of water (4 ounces/120||
5194|084|H|milliliters) and drink right away. Mixing your dose in water||
5194|085|H|before you take it will prevent your mouth from becoming numb.||
5194|086|H|   The dosage is based on your medical condition, response to||
5194|087|H|treatment, and other medications you may be taking. Children's||
5194|088|H|dosage is also based on weight. Be sure to tell your doctor and||
5194|089|H|pharmacist about all the products you use (including prescription||
5194|090|H|drugs, nonprescription drugs, and herbal products). Do not||
5194|091|H|increase your dose or use this drug more often or for longer than||
5194|092|H|prescribed because your risk of side effects may increase.||
5194|093|H|Properly stop the medication when so directed.||
5194|094|H|   Pain medications work best if they are used as the first signs||
5194|095|H|of pain occur. If you wait until the pain has worsened, the||
5194|096|H|medication may not work as well.||
5194|097|H|   Suddenly stopping this medication may cause withdrawal,||
5194|098|H|especially if you have used it for a long time or in high doses.||
5194|099|H|To prevent withdrawal, your doctor may lower your dose slowly.||
5194|100|H|Tell your doctor or pharmacist right away if you have any||
5194|101|H|withdrawal symptoms such as restlessness, mental/mood changes||
5194|102|H|(including anxiety, trouble sleeping, thoughts of suicide),||
5194|103|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
5194|104|H|aches, or sudden changes in behavior.||
5194|105|H|   When this medication is used for a long time, it may not work||
5194|106|H|as well. Talk with your doctor if this medication stops working||
5194|107|H|well.||
5194|108|H|   Though it helps many people, this medication may sometimes||
5194|109|H|cause addiction. This risk may be higher if you have a||
5194|110|H|mental/mood disorder or a substance use disorder (such as overuse||
5194|111|H|of or addiction to drugs/alcohol). Take this medication exactly||
5194|112|H|as prescribed to lower the risk of addiction. Ask your doctor or||
5194|113|H|pharmacist for more details.||
5194|114|H|   Tell your doctor if your pain does not get better or if it||
5194|115|H|gets worse, or if you have any new pain.||
5194|116|B|||
5194|117|S|SIDE EFFECTS:  See also Warning section.||
5194|118|S|   Nausea, vomiting, constipation, sweating, lightheadedness,||
5194|119|S|dizziness, or drowsiness may occur. If any of these effects last||
5194|120|S|or get worse, tell your doctor or pharmacist promptly.||
5194|121|S|   To prevent constipation, eat dietary fiber, drink enough||
5194|122|S|water, and exercise. You may also need to take a laxative. Ask||
5194|123|S|your pharmacist which type of laxative is right for you.||
5194|124|S|   To reduce the risk of dizziness and lightheadedness, get up||
5194|125|S|slowly when rising from a sitting or lying position.||
5194|126|S|   Remember that this medication has been prescribed because your||
5194|127|S|doctor has judged that the benefit to you is greater than the||
5194|128|S|risk of side effects. Many people using this medication do not||
5194|129|S|have serious side effects.||
5194|130|S|   Tell your doctor right away if you have any serious side||
5194|131|S|effects, including: interrupted breathing during sleep (sleep||
5194|132|S|apnea), mental/mood changes (such as agitation, confusion,||
5194|133|S|hallucinations), trouble swallowing, stomach/abdominal pain,||
5194|134|S|difficulty urinating, slow/irregular/fast heartbeat, shaking||
5194|135|S|(tremors), vision changes, signs of your adrenal glands not||
5194|136|S|working well (such as loss of appetite, unusual tiredness, weight||
5194|137|S|loss).||
5194|138|S|   Get medical help right away if you have any very serious side||
5194|139|S|effects, including: fainting, seizure, severe||
5194|140|S|drowsiness/difficulty waking up.||
5194|141|S|   This medication may increase serotonin and rarely cause a very||
5194|142|S|serious condition called serotonin syndrome/toxicity. The risk||
5194|143|S|increases if you are also taking other drugs that increase||
5194|144|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
5194|145|S|take (see Drug Interactions section). Get medical help right away||
5194|146|S|if you develop some of the following symptoms: fast heartbeat,||
5194|147|S|hallucinations, loss of coordination, severe dizziness, severe||
5194|148|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
5194|149|S|unusual agitation/restlessness.||
5194|150|S|   A very serious allergic reaction to this drug is rare.||
5194|151|S|However, get medical help right away if you notice any symptoms||
5194|152|S|of a serious allergic reaction, including: rash, itching/swelling||
5194|153|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5194|154|S|breathing.||
5194|155|S|   This is not a complete list of possible side effects. If you||
5194|156|S|notice other effects not listed above, contact your doctor or||
5194|157|S|pharmacist.||
5194|158|S|   In the US -||
5194|159|S|   Call your doctor for medical advice about side effects. You||
5194|160|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5194|161|S|www.fda.gov/medwatch.||
5194|162|S|   In Canada - Call your doctor for medical advice about side||
5194|163|S|effects. You may report side effects to Health Canada at||
5194|164|S|1-866-234-2345.||
5194|165|B|||
5194|166|P|PRECAUTIONS:  Before taking meperidine, tell your doctor or||
5194|167|P|pharmacist if you are allergic to it; or if you have any other||
5194|168|P|allergies. This product may contain inactive ingredients, which||
5194|169|P|can cause allergic reactions or other problems. Talk to your||
5194|170|P|pharmacist for more details.||
5194|171|P|   Before taking this medication, tell your doctor or pharmacist||
5194|172|P|your medical history, especially of: brain disorders (such as||
5194|173|P|head injury, tumor, seizures), breathing problems (such as||
5194|174|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
5194|175|P|gallbladder disease, kidney disease, liver disease, mental/mood||
5194|176|P|disorders (such as confusion, depression, thoughts of suicide),||
5194|177|P|personal or family history of a substance use disorder (such as||
5194|178|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
5194|179|P|problems (such as blockage, constipation, diarrhea due to||
5194|180|P|infection, paralytic ileus), disease of the pancreas||
5194|181|P|(pancreatitis), difficulty urinating (such as due to enlarged||
5194|182|P|prostate), a certain adrenal gland tumor (pheochromocytoma),||
5194|183|P|heart problems (such as fast/irregular heartbeat), sickle cell||
5194|184|P|anemia.||
5194|185|P|   Meperidine is usually used only for a short time. Repeated or||
5194|186|P|high doses may cause drug levels to build up in the body and||
5194|187|P|cause serious side effects such as seizures and shaking. Caution||
5194|188|P|is advised if this medication is used for conditions that require||
5194|189|P|long-term or high-dosage treatment (such as sickle cell anemia,||
5194|190|P|burns, cancer). Consult your doctor or pharmacist for details.||
5194|191|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5194|192|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5194|193|P|machinery, or do anything that needs alertness until you can do||
5194|194|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5194|195|P|are using marijuana (cannabis).||
5194|196|P|   Before having surgery, tell your doctor or dentist about all||
5194|197|P|the products you use (including prescription drugs,||
5194|198|P|nonprescription drugs, and herbal products).||
5194|199|P|   Older adults may be more sensitive to the side effects of this||
5194|200|P|drug, especially confusion, dizziness, drowsiness, and||
5194|201|P|slow/shallow breathing.||
5194|202|P|   Children may be more sensitive to the side effects of this||
5194|203|P|drug, especially severe drowsiness and slow/shallow breathing.||
5194|204|P|   During pregnancy, this medication should be used only when||
5194|205|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
5194|206|P|benefits with your doctor. (See also Warning section.)||
5194|207|P|   This drug passes into breast milk and may have undesirable||
5194|208|P|effects on a nursing infant. Tell the doctor right away if your||
5194|209|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
5194|210|P|breathing. Consult your doctor before breastfeeding.||
5194|211|B|||
5194|212|I|DRUG INTERACTIONS:  See also Warning section.||
5194|213|I|   Drug interactions may change how your medications work or||
5194|214|I|increase your risk for serious side effects. This document does||
5194|215|I|not contain all possible drug interactions. Keep a list of all||
5194|216|I|the products you use (including prescription/nonprescription||
5194|217|I|drugs and herbal products) and share it with your doctor and||
5194|218|I|pharmacist. Do not start, stop, or change the dosage of any||
5194|219|I|medicines without your doctor's approval.||
5194|220|I|   Some products that may interact with this drug include:||
5194|221|I|certain pain medications (mixed opioid agonist-antagonists such||
5194|222|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
5194|223|I|samidorphan.||
5194|224|I|   Taking MAO inhibitors with this medication may cause a serious||
5194|225|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
5194|226|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
5194|227|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
5194|228|I|selegiline, tranylcypromine) during treatment with this||
5194|229|I|medication. Most MAO inhibitors should also not be taken for two||
5194|230|I|weeks before treatment with this medication. Ask your doctor when||
5194|231|I|to start or stop taking this medication.||
5194|232|I|   The risk of serious side effects (such as slow/shallow||
5194|233|I|breathing, severe drowsiness/dizziness) may be increased if this||
5194|234|I|medication is used with other products that may also cause||
5194|235|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5194|236|I|if you are taking other products such as other opioid pain or||
5194|237|I|cough relievers (such as codeine, hydrocodone), alcohol,||
5194|238|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
5194|239|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
5194|240|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
5194|241|I|cetirizine, diphenhydramine).||
5194|242|I|   Check the labels on all your medicines (such as allergy or||
5194|243|I|cough-and-cold products) because they may contain ingredients||
5194|244|I|that cause drowsiness. Ask your pharmacist about using those||
5194|245|I|products safely.||
5194|246|I|   The risk of serotonin syndrome/toxicity increases if you are||
5194|247|I|also taking other drugs that increase serotonin. Examples include||
5194|248|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
5194|249|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
5194|250|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
5194|251|I|serotonin syndrome/toxicity may be more likely when you start or||
5194|252|I|increase the dose of these drugs.||
5194|253|I|   Other medications can affect the removal of meperidine from||
5194|254|I|your body, which may affect how meperidine works. Examples||
5194|255|I|include azole antifungals (such as ketoconazole), macrolide||
5194|256|I|antibiotics (such as erythromycin), mifepristone, rifamycins||
5194|257|I|(such as rifabutin), ritonavir, drugs used to treat seizures||
5194|258|I|(such as carbamazepine, phenytoin), among others.||
5194|259|I|   This medication may interfere with certain lab tests (such as||
5194|260|I|amylase/lipase tests), possibly causing false test results. Make||
5194|261|I|sure lab personnel and all your doctors know you use this drug.||
5194|262|B|||
5194|263|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5194|264|O|as passing out or trouble breathing, give them naloxone or||
5194|265|O|nalmefene if available, then call 911. If the person is awake and||
5194|266|O|has no symptoms, call a poison control center right away. US||
5194|267|O|residents can call 1-800-222-1222. Canada residents can call||
5194|268|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
5194|269|O|breathing, severe drowsiness, coma.||
5194|270|B|||
5194|271|N|NOTES:  Do not share this medication with others. Sharing it is||
5194|272|N|against the law.||
5194|273|N|   This medication has been prescribed for your current condition||
5194|274|N|only. Do not use it later for another condition unless your||
5194|275|N|doctor directs you to do so. A different medication may be||
5194|276|N|necessary in that case.||
5194|277|B|||
5194|278|D|MISSED DOSE:  Not applicable.||
5194|279|B|||
5194|280|R|STORAGE:  Store at room temperature away from light and moisture.||
5194|281|R|Do not store in the bathroom. Keep all medications away from||
5194|282|R|children and pets.||
5194|283|R|   Do not flush medications down the toilet or pour them into a||
5194|284|R|drain unless instructed to do so. Properly discard this product||
5194|285|R|when it is expired or no longer needed. For more details, read||
5194|286|R|the Medication Guide, or consult your pharmacist or local waste||
5194|287|R|disposal company.||
5194|288|B|||
5194|289|A|Information last revised August 2025.||
5194|290|A|Copyright(c) 2025 First Databank, Inc.||
5194|291|B|||
5196|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5196|002|Z|does NOT have all possible information about this product. This||
5196|003|Z|information does not assure that this product is safe, effective,||
5196|004|Z|or appropriate for you. This information is not individual||
5196|005|Z|medical advice and does not substitute for the advice of your||
5196|006|Z|health care professional. Always ask your health care||
5196|007|Z|professional for complete information about this product and your||
5196|008|Z|specific health needs.||
5196|009|B|||
5196|010|T|CIPROFLOXACIN/HYDROCORTISONE SUSPENSION - OTIC||
5196|011|F|(SIP-roe-FLOX-a-sin/hi-dro-KOR-tih-sown)||
5196|012|B|||
5196|013|C|COMMON BRAND NAME(S): Cipro HC||
5196|014|B|||
5196|015|U|USES:  This medication is used to treat bacterial ear infections.||
5196|016|U|It is used to treat outer ear infections (also known as swimmer's||
5196|017|U|ear) in children and adults. This medication contains a||
5196|018|U|combination of ciprofloxacin (a quinolone-type antibiotic) and||
5196|019|U|hydrocortisone (an anti-inflammatory corticosteroid). This ear||
5196|020|U|drop works by stopping the growth of bacteria and reducing ear||
5196|021|U|swelling and discomfort.||
5196|022|U|   This medication treats only bacterial ear infections. It will||
5196|023|U|not work for other types of ear infections. Unnecessary use or||
5196|024|U|overuse of any antibiotic can lead to its decreased||
5196|025|U|effectiveness.||
5196|026|B|||
5196|027|H|HOW TO USE:  Use this medication as directed by your doctor,||
5196|028|H|usually twice daily (every 12 hours). The ear canal should be||
5196|029|H|clean and dry before using this medication.||
5196|030|H|   To make sure that the right amount of medication is given, and||
5196|031|H|to avoid touching the ear with the dropper, have another person||
5196|032|H|give the drops if possible. To lower the risk of dizziness, hold||
5196|033|H|the container in your hand for a few minutes in order to warm it.||
5196|034|H|   To apply ear drops, wash your hands first. To avoid||
5196|035|H|contamination, do not touch the dropper tip or let it touch your||
5196|036|H|ear or any other surface. Shake the container well before using.||
5196|037|H|   Lie on your side with the treated ear upward. Hold the dropper||
5196|038|H|directly over the ear, and place the prescribed number of drops||
5196|039|H|into the ear canal. To help the drops roll into the ear of an||
5196|040|H|adult, hold the earlobe up and back. For children, hold the||
5196|041|H|earlobe down and back. Keep the head tilted with the treated ear||
5196|042|H|upward for about 1 minute, or insert a soft cotton plug if so||
5196|043|H|directed. Repeat the above steps for the other ear if so||
5196|044|H|directed. Do not rinse the dropper. Replace the cap after use.||
5196|045|H|   Use this medication regularly in order to get the most benefit||
5196|046|H|from it. To help you remember, use it at the same times each day.||
5196|047|H|Continue to use this medication for the full time prescribed,||
5196|048|H|even if symptoms disappear after a few days. Stopping the||
5196|049|H|medication too early may result in a return of the infection.||
5196|050|H|   Tell your doctor if your condition lasts or gets worse after 7||
5196|051|H|days of treatment. Report any fluid you find in the ear after||
5196|052|H|treatment is completed.||
5196|053|H|   Do not use in the eye.||
5196|054|B|||
5196|055|S|SIDE EFFECTS:  Headache may occur with the use of this||
5196|056|S|medication. If this effect lasts or gets worse, tell your doctor||
5196|057|S|or pharmacist promptly.||
5196|058|S|   Remember that this medication has been prescribed because your||
5196|059|S|doctor has judged that the benefit to you is greater than the||
5196|060|S|risk of side effects. Many people using this medication do not||
5196|061|S|have serious side effects.||
5196|062|S|   Use of this medication for prolonged or repeated periods may||
5196|063|S|result in a new fungal ear infection. Do not use this medication||
5196|064|S|for longer than prescribed. Contact your doctor if you notice new||
5196|065|S|or worsening symptoms.||
5196|066|S|   A very serious allergic reaction to this drug is rare.||
5196|067|S|However, get medical help right away if you notice any symptoms||
5196|068|S|of a serious allergic reaction, including: rash, itching/swelling||
5196|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5196|070|S|breathing.||
5196|071|S|   This is not a complete list of possible side effects. If you||
5196|072|S|notice other effects not listed above, contact your doctor or||
5196|073|S|pharmacist.||
5196|074|S|   In the US -||
5196|075|S|   Call your doctor for medical advice about side effects. You||
5196|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5196|077|S|www.fda.gov/medwatch.||
5196|078|S|   In Canada - Call your doctor for medical advice about side||
5196|079|S|effects. You may report side effects to Health Canada at||
5196|080|S|1-866-234-2345.||
5196|081|B|||
5196|082|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
5196|083|P|pharmacist if you are allergic to quinolone antibiotics (such as||
5196|084|P|ciprofloxacin, levofloxacin), or to corticosteroids (such as||
5196|085|P|hydrocortisone, prednisone); or if you have any other allergies.||
5196|086|P|This product may contain inactive ingredients, which can cause||
5196|087|P|allergic reactions or other problems. Talk to your pharmacist for||
5196|088|P|more details.||
5196|089|P|   Before using this medication, tell your doctor or pharmacist||
5196|090|P|your medical history, especially of: a hole in your ear drum, an||
5196|091|P|ear infection caused by a virus (such as herpes simplex,||
5196|092|P|varicella).||
5196|093|P|   During pregnancy, this medication should be used only when||
5196|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
5196|095|P|   This medication passes into breast milk but is unlikely to||
5196|096|P|harm a nursing infant. Consult your doctor before breastfeeding.||
5196|097|B|||
5196|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5196|099|I|medications work or increase your risk for serious side effects.||
5196|100|I|This document does not contain all possible drug interactions.||
5196|101|I|Keep a list of all the products you use (including||
5196|102|I|prescription/nonprescription drugs and herbal products) and share||
5196|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
5196|104|I|the dosage of any medicines without your doctor's approval.||
5196|105|B|||
5196|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5196|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5196|108|O|poison control center right away. US residents can call||
5196|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
5196|110|O|medicine may be harmful if swallowed.||
5196|111|B|||
5196|112|N|NOTES:  Do not share this medication with others.||
5196|113|N|   This medication has been prescribed for your current condition||
5196|114|N|only. Throw away the unused medication after treatment is||
5196|115|N|completed. Do not use it later for another infection unless your||
5196|116|N|doctor tells you to.||
5196|117|N|   It is important to keep the infected ear(s) clean and dry. Try||
5196|118|N|not to get the infected ear(s) wet when bathing. Avoid swimming||
5196|119|N|unless your doctor tells you otherwise.||
5196|120|B|||
5196|121|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5196|122|D|If it is near the time of the next dose, skip the missed dose.||
5196|123|D|Use your next dose at the regular time. Do not double the dose to||
5196|124|D|catch up.||
5196|125|B|||
5196|126|R|STORAGE:  Store at room temperature away from light. Do not||
5196|127|R|freeze. Keep all medications away from children and pets.||
5196|128|R|   Do not flush medications down the toilet or pour them into a||
5196|129|R|drain unless instructed to do so. Properly discard this product||
5196|130|R|when it is expired or no longer needed. Consult your pharmacist||
5196|131|R|or local waste disposal company.||
5196|132|B|||
5196|133|A|Information last revised May 2024.||
5196|134|A|Copyright(c) 2025 First Databank, Inc.||
5196|135|B|||
5202|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5202|002|Z|does NOT have all possible information about this product. This||
5202|003|Z|information does not assure that this product is safe, effective,||
5202|004|Z|or appropriate for you. This information is not individual||
5202|005|Z|medical advice and does not substitute for the advice of your||
5202|006|Z|health care professional. Always ask your health care||
5202|007|Z|professional for complete information about this product and your||
5202|008|Z|specific health needs.||
5202|009|B|||
5202|010|T|SODIUM PHENYLBUTYRATE POWDER - ORAL||
5202|011|F|(SOE-dee-um FEN-il-BUE-ti-rate)||
5202|012|B|||
5202|013|C|COMMON BRAND NAME(S): Buphenyl||
5202|014|B|||
5202|015|U|USES:  This medication is used along with diet changes for||
5202|016|U|long-term treatment of a certain inherited disorder (urea cycle||
5202|017|U|disorder). Sodium phenylbutyrate helps remove a certain chemical||
5202|018|U|(ammonia) from the body. Too much ammonia in the body can cause||
5202|019|U|brain damage and sometimes death.||
5202|020|U|   This medication should not be used to treat sudden, severely||
5202|021|U|high levels of ammonia in the body. Get medical help right away||
5202|022|U|if you have sudden symptoms of too much ammonia (such as trouble||
5202|023|U|thinking, nausea, vomiting, irritability, trouble speaking,||
5202|024|U|trouble walking, fainting).||
5202|025|B|||
5202|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5202|027|H|from your pharmacist before you start using sodium phenylbutyrate||
5202|028|H|and each time you get a refill. If you have any questions, ask||
5202|029|H|your doctor or pharmacist.||
5202|030|H|   Take this medication by mouth or by feeding tube||
5202|031|H|(nasogastric/gastric), exactly as directed by your doctor. Shake||
5202|032|H|the bottle lightly before each use. Using the measuring device||
5202|033|H|provided, measure out the dose prescribed by your doctor. Mix||
5202|034|H|with solid or liquid food, and take all of the mixture right||
5202|035|H|away.||
5202|036|H|   The dosage is based on your weight or body size, medical||
5202|037|H|condition, and response to treatment. The total daily dose should||
5202|038|H|be divided into equal amounts and taken with each meal or feeding||
5202|039|H|(such as 3 to 6 times daily). Do not increase or decrease your||
5202|040|H|dose without your doctor's approval.||
5202|041|H|   Use this medication regularly to get the most benefit from it.||
5202|042|H|To help you remember, take it at the same times each day.||
5202|043|B|||
5202|044|S|SIDE EFFECTS:  Loss of appetite or menstrual changes||
5202|045|S|(delayed/irregular/absent periods) may occur. If any of these||
5202|046|S|effects last or get worse, tell your doctor or pharmacist||
5202|047|S|promptly.||
5202|048|S|   Remember that this medication has been prescribed because your||
5202|049|S|doctor has judged that the benefit to you is greater than the||
5202|050|S|risk of side effects. Many people using this medication do not||
5202|051|S|have serious side effects.||
5202|052|S|   Tell your doctor right away if you have any serious side||
5202|053|S|effects, including: drowsiness/lightheadedness, fast/pounding||
5202|054|S|heartbeat, mental/mood changes (such as confusion), unusual||
5202|055|S|tiredness.||
5202|056|S|   A very serious allergic reaction to this drug is rare.||
5202|057|S|However, get medical help right away if you notice any symptoms||
5202|058|S|of a serious allergic reaction, including: rash, itching/swelling||
5202|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5202|060|S|breathing.||
5202|061|S|   This is not a complete list of possible side effects. If you||
5202|062|S|notice other effects not listed above, contact your doctor or||
5202|063|S|pharmacist.||
5202|064|S|   In the US -||
5202|065|S|   Call your doctor for medical advice about side effects. You||
5202|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5202|067|S|www.fda.gov/medwatch.||
5202|068|S|   In Canada - Call your doctor for medical advice about side||
5202|069|S|effects. You may report side effects to Health Canada at||
5202|070|S|1-866-234-2345.||
5202|071|B|||
5202|072|P|PRECAUTIONS:  Before taking sodium phenylbutyrate, tell your||
5202|073|P|doctor or pharmacist if you are allergic to it; or if you have||
5202|074|P|any other allergies. This product may contain inactive||
5202|075|P|ingredients, which can cause allergic reactions or other||
5202|076|P|problems. Talk to your pharmacist for more details.||
5202|077|P|   Before using this medication, tell your doctor or pharmacist||
5202|078|P|your medical history, especially of: a certain heart problem||
5202|079|P|(heart failure), kidney disease, liver disease, swelling (edema).||
5202|080|P|   This medication contains salt (sodium). Before taking this||
5202|081|P|medication, tell your doctor or pharmacist if you are on a||
5202|082|P|low-salt diet.||
5202|083|P|   Before having surgery, tell your doctor or dentist about all||
5202|084|P|the products you use (including prescription drugs,||
5202|085|P|nonprescription drugs, and herbal products).||
5202|086|P|   During pregnancy, this medication should be used only when||
5202|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
5202|088|P|   It is unknown if this medication passes into breast milk.||
5202|089|P|Consult your doctor before breastfeeding.||
5202|090|B|||
5202|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5202|092|I|medications work or increase your risk for serious side effects.||
5202|093|I|This document does not contain all possible drug interactions.||
5202|094|I|Keep a list of all the products you use (including||
5202|095|I|prescription/nonprescription drugs and herbal products) and share||
5202|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
5202|097|I|the dosage of any medicines without your doctor's approval.||
5202|098|B|||
5202|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5202|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5202|101|O|poison control center right away. US residents can call||
5202|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5202|103|B|||
5202|104|N|NOTES:  Do not share this medication with others.||
5202|105|N|   Lab and/or medical tests (such as plasma ammonia/amino acid||
5202|106|N|levels, complete blood count, blood potassium level, urine tests,||
5202|107|N|drug levels) should be done while you are taking this medication.||
5202|108|N|Keep all medical and lab appointments. Consult your doctor for||
5202|109|N|more details.||
5202|110|B|||
5202|111|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5202|112|D|remember. If it is near the time of the next dose, skip the||
5202|113|D|missed dose. Take your next dose at the regular time. Do not||
5202|114|D|double the dose to catch up.||
5202|115|B|||
5202|116|R|STORAGE:  Store at room temperature away from light and moisture.||
5202|117|R|Do not store in the bathroom. Keep all medications away from||
5202|118|R|children and pets.||
5202|119|R|   Do not flush medications down the toilet or pour them into a||
5202|120|R|drain unless instructed to do so. Properly discard this product||
5202|121|R|when it is expired or no longer needed. Consult your pharmacist||
5202|122|R|or local waste disposal company.||
5202|123|B|||
5202|124|A|Information last revised January 2025.||
5202|125|A|Copyright(c) 2025 First Databank, Inc.||
5202|126|B|||
5204|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5204|002|Z|does NOT have all possible information about this product. This||
5204|003|Z|information does not assure that this product is safe, effective,||
5204|004|Z|or appropriate for you. This information is not individual||
5204|005|Z|medical advice and does not substitute for the advice of your||
5204|006|Z|health care professional. Always ask your health care||
5204|007|Z|professional for complete information about this product and your||
5204|008|Z|specific health needs.||
5204|009|B|||
5204|010|T|CETIRIZINE - ORAL||
5204|011|F|(seh-TEER-ah-zeen)||
5204|012|B|||
5204|013|C|COMMON BRAND NAME(S): Zyrtec||
5204|014|B|||
5204|015|U|USES:  Cetirizine is an antihistamine used to relieve allergy||
5204|016|U|symptoms such as watery eyes, runny nose, itching eyes/nose,||
5204|017|U|sneezing, hives, and itching. It works by blocking a certain||
5204|018|U|natural substance (histamine) that your body makes during an||
5204|019|U|allergic reaction.||
5204|020|U|   Cetirizine does not prevent hives or prevent/treat a serious||
5204|021|U|allergic reaction (such as anaphylaxis). If your doctor has||
5204|022|U|prescribed epinephrine to treat allergic reactions, always carry||
5204|023|U|your epinephrine injector with you. Do not use cetirizine in||
5204|024|U|place of your epinephrine.||
5204|025|B|||
5204|026|H|HOW TO USE:  If you are taking the over-the-counter product to||
5204|027|H|self-treat, read all directions on the product package before||
5204|028|H|taking this medication. If you have any questions, consult your||
5204|029|H|pharmacist. If your doctor has prescribed this medication, take||
5204|030|H|it as directed, usually once daily.||
5204|031|H|   If you are using the chewable tablets, chew each tablet well||
5204|032|H|and swallow. If you are using the rapidly-dissolving tablet,||
5204|033|H|allow the tablet to dissolve on the tongue and then swallow, with||
5204|034|H|or without water. If you are using the liquid form of this||
5204|035|H|medication, measure the dose carefully using a special measuring||
5204|036|H|device/spoon. Do not use a household spoon because you may not||
5204|037|H|get the correct dose.||
5204|038|H|   The dosage is based on your age, medical condition, and||
5204|039|H|response to treatment. Do not increase your dose or take this||
5204|040|H|medication more often than directed.||
5204|041|H|   Tell your doctor if your allergy symptoms do not get better,||
5204|042|H|if your hives do not improve after 3 days of treatment, or if||
5204|043|H|your hives last more than 6 weeks. Get medical help right away if||
5204|044|H|your condition gets worse or if you think you have a serious||
5204|045|H|medical problem (such as a very serious allergic||
5204|046|H|reaction/anaphylaxis).||
5204|047|B|||
5204|048|S|SIDE EFFECTS:  Drowsiness, tiredness, and dry mouth may occur.||
5204|049|S|Stomach pain may also occur, especially in children. If any of||
5204|050|S|these effects last or get worse, tell your doctor or pharmacist||
5204|051|S|promptly.||
5204|052|S|   If your doctor has prescribed this medication, remember that||
5204|053|S|your doctor has judged that the benefit to you is greater than||
5204|054|S|the risk of side effects. Many people using this medication do||
5204|055|S|not have serious side effects.||
5204|056|S|   Tell your doctor right away if you have any serious side||
5204|057|S|effects, including: difficulty urinating, weakness.||
5204|058|S|   Rarely, severe itching may occur after stopping the long-term||
5204|059|S|use of this medication (taking the medication for a few months to||
5204|060|S|years). Talk to your doctor about the risks and benefits of this||
5204|061|S|medication, especially if you are using it regularly for a long||
5204|062|S|time. Tell your doctor right away if itching occurs after||
5204|063|S|stopping the medication.||
5204|064|S|   A very serious allergic reaction to this drug is rare.||
5204|065|S|However, get medical help right away if you notice any symptoms||
5204|066|S|of a serious allergic reaction, including: rash, itching/swelling||
5204|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5204|068|S|breathing.||
5204|069|S|   This is not a complete list of possible side effects. If you||
5204|070|S|notice other effects not listed above, contact your doctor or||
5204|071|S|pharmacist.||
5204|072|S|   In the US -||
5204|073|S|   Call your doctor for medical advice about side effects. You||
5204|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5204|075|S|www.fda.gov/medwatch.||
5204|076|S|   In Canada - Call your doctor for medical advice about side||
5204|077|S|effects. You may report side effects to Health Canada at||
5204|078|S|1-866-234-2345.||
5204|079|B|||
5204|080|P|PRECAUTIONS:  Before taking cetirizine, tell your doctor or||
5204|081|P|pharmacist if you are allergic to it; or to hydroxyzine; or to||
5204|082|P|levocetirizine; or if you have any other allergies. This product||
5204|083|P|may contain inactive ingredients, which can cause allergic||
5204|084|P|reactions or other problems. Talk to your pharmacist for more||
5204|085|P|details.||
5204|086|P|   Before using this medication, tell your doctor or pharmacist||
5204|087|P|your medical history, especially of: difficulty urinating (such||
5204|088|P|as due to an enlarged prostate), kidney disease, liver disease.||
5204|089|P|   If you are using this medication to treat hives, tell your||
5204|090|P|doctor right away if you have any of these other symptoms because||
5204|091|P|they may be signs of a more serious condition: hives that are an||
5204|092|P|unusual color, hives that look bruised or blistered, hives that||
5204|093|P|do not itch.||
5204|094|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
5204|095|P|can make you more drowsy. Do not drive, use machinery, or do||
5204|096|P|anything that needs alertness until you can do it safely. Avoid||
5204|097|P|alcoholic beverages. Talk to your doctor if you are using||
5204|098|P|marijuana (cannabis).||
5204|099|P|   Liquid products may contain sugar. Caution is advised if you||
5204|100|P|have diabetes. Ask your doctor or pharmacist about using this||
5204|101|P|product safely.||
5204|102|P|   Before having surgery, tell your doctor or dentist about all||
5204|103|P|the products you use (including prescription drugs,||
5204|104|P|nonprescription drugs, and herbal products).||
5204|105|P|   During pregnancy, this medication should be used only when||
5204|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
5204|107|P|   This medication passes into breast milk. Consult your doctor||
5204|108|P|before breastfeeding.||
5204|109|B|||
5204|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5204|111|I|medications work or increase your risk for serious side effects.||
5204|112|I|This document does not contain all possible drug interactions.||
5204|113|I|Keep a list of all the products you use (including||
5204|114|I|prescription/nonprescription drugs and herbal products) and share||
5204|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
5204|116|I|the dosage of any medicines without your doctor's approval.||
5204|117|I|   Tell your doctor or pharmacist if you are taking other||
5204|118|I|products that cause drowsiness such as opioid pain or cough||
5204|119|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5204|120|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5204|121|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5204|122|I|cyclobenzaprine), or other antihistamines (such as||
5204|123|I|chlorpheniramine, diphenhydramine).||
5204|124|I|   Check the labels on all your medicines (such as allergy or||
5204|125|I|cough-and-cold products) because they may contain ingredients||
5204|126|I|that cause drowsiness. Ask your pharmacist about using those||
5204|127|I|products safely.||
5204|128|I|   Do not use with any other antihistamines applied to the skin||
5204|129|I|(such as diphenhydramine cream, ointment, spray) because||
5204|130|I|increased side effects may occur.||
5204|131|I|   Cetirizine is very similar to hydroxyzine and levocetirizine.||
5204|132|I|Do not use these medications while using cetirizine.||
5204|133|I|   This medication may interfere with certain lab tests (such as||
5204|134|I|allergy skin testing), possibly causing false test results. Make||
5204|135|I|sure lab personnel and all your doctors know you use this drug.||
5204|136|B|||
5204|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5204|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5204|139|O|poison control center right away. US residents can call||
5204|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5204|141|O|Symptoms of overdose may include: severe drowsiness. In children,||
5204|142|O|mental/mood changes (such as restlessness, irritability) may||
5204|143|O|occur before drowsiness.||
5204|144|B|||
5204|145|N|NOTES:  Keep all medical and lab appointments.||
5204|146|B|||
5204|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5204|148|D|remember. If it is near the time of the next dose, skip the||
5204|149|D|missed dose. Take your next dose at the regular time. Do not||
5204|150|D|double the dose to catch up.||
5204|151|B|||
5204|152|R|STORAGE:  Store at room temperature away from light and moisture.||
5204|153|R|Do not store in the bathroom. Different brands of this medication||
5204|154|R|may have different storage needs. Check the product package for||
5204|155|R|instructions on how to store your brand, or ask your pharmacist.||
5204|156|R|Keep all medications away from children and pets.||
5204|157|R|   Do not flush medications down the toilet or pour them into a||
5204|158|R|drain unless instructed to do so. Properly discard this product||
5204|159|R|when it is expired or no longer needed. Consult your pharmacist||
5204|160|R|or local waste disposal company.||
5204|161|B|||
5204|162|A|Information last revised May 2025.||
5204|163|A|Copyright(c) 2025 First Databank, Inc.||
5204|164|B|||
5217|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5217|002|Z|does NOT have all possible information about this product. This||
5217|003|Z|information does not assure that this product is safe, effective,||
5217|004|Z|or appropriate for you. This information is not individual||
5217|005|Z|medical advice and does not substitute for the advice of your||
5217|006|Z|health care professional. Always ask your health care||
5217|007|Z|professional for complete information about this product and your||
5217|008|Z|specific health needs.||
5217|009|B|||
5217|010|T|VIGABATRIN POWDER PACKETS - ORAL||
5217|011|F|(vye-GAB-uh-trin)||
5217|012|B|||
5217|013|C|COMMON BRAND NAME(S): Sabril||
5217|014|B|||
5217|015|W|WARNING:  Serious vision problems may occur while taking this||
5217|016|W|medication and may be permanent even after you stop taking the||
5217|017|W|medication. To prevent vision problems from getting worse, your||
5217|018|W|doctor must find any eye problems as early as possible. Also,||
5217|019|W|tell your doctor if you have a history of vision problems. It is||
5217|020|W|very important that you have an eye exam before or within 4 weeks||
5217|021|W|of starting this medication, then every 3 months thereafter while||
5217|022|W|you are taking this medication. You should also have an eye exam||
5217|023|W|3 to 6 months after stopping this medication. Follow your||
5217|024|W|doctor's directions carefully and keep all medical/eye/lab||
5217|025|W|appointments. Tell your doctor right away if you have any changes||
5217|026|W|in vision (such as loss of vision, blurred vision, double vision,||
5217|027|W|sensitivity to light, eye pain).||
5217|028|W|   To receive vigabatrin in the United States, you must||
5217|029|W|understand, agree to, and carefully follow the requirements of||
5217|030|W|the REMS Program for this medication. If you live in Canada or||
5217|031|W|any other country, consult your doctor and pharmacist for your||
5217|032|W|country's regulations.||
5217|033|B|||
5217|034|U|USES:  Vigabatrin is used to treat babies, one month to 2 years||
5217|035|U|old who have a condition known as infantile spasms. Vigabatrin||
5217|036|U|has also been used in combination with other medications to treat||
5217|037|U|seizure disorders (epilepsy). Vigabatrin decreases the number of||
5217|038|U|seizures in adults and children who have not been able to control||
5217|039|U|their seizures with other treatment. Vigabatrin is an||
5217|040|U|anticonvulsant. It is thought to work by stopping the breakdown||
5217|041|U|of a natural calming substance (GABA) in the brain.||
5217|042|B|||
5217|043|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
5217|044|H|sheet provided by your pharmacist before you start taking||
5217|045|H|vigabatrin and each time you get a refill. If you have any||
5217|046|H|questions, ask your doctor or pharmacist.||
5217|047|H|   Mix the contents of the packet with water as directed by the||
5217|048|H|Instructions for Use sheet. Measure the dose using the supplied||
5217|049|H|oral syringe. Do not use a household spoon because you may not||
5217|050|H|get the correct dose. Use the dose right after mixing. Do not mix||
5217|051|H|in advance or store for future use. Discard any unused||
5217|052|H|medication.||
5217|053|H|   Take this medication by mouth with or without food as directed||
5217|054|H|by your doctor, usually twice a day.||
5217|055|H|   The dosage is based on your medical condition and response to||
5217|056|H|treatment. Children's dosage is also based on weight. Your doctor||
5217|057|H|may direct you to take a low dose at first, gradually increasing||
5217|058|H|the dose to lower the chance of side effects such as drowsiness||
5217|059|H|and confusion. Your doctor will adjust your dose to find the best||
5217|060|H|dose for you. Follow your doctor's directions carefully.||
5217|061|H|   Take this medication regularly to get the most benefit from||
5217|062|H|it. To help you remember, take it at the same times each day.||
5217|063|H|   Do not increase your dose or take this medication more often||
5217|064|H|than prescribed. Your condition will not improve any faster, and||
5217|065|H|the risk of serious side effects may be increased. Do not stop||
5217|066|H|taking this medication without consulting your doctor. Your||
5217|067|H|condition may become worse when the drug is suddenly stopped.||
5217|068|H|Your dose may need to be gradually decreased.||
5217|069|H|   For infantile spasms, tell the doctor if your infant's spasms||
5217|070|H|get worse or do not get better within 2 to 4 weeks. For seizures,||
5217|071|H|tell your doctor if your seizures get worse or do not get better||
5217|072|H|within 3 months.||
5217|073|B|||
5217|074|S|SIDE EFFECTS:  See also Warning section.||
5217|075|S|   Drowsiness, dizziness, and difficulty concentrating may occur,||
5217|076|S|especially during the first few days as your body adjusts to the||
5217|077|S|medication. Children may become restless or excited. Nausea,||
5217|078|S|vomiting, stomach upset, diarrhea, headache, weight gain, and||
5217|079|S|tiredness may also occur. If any of these effects last or get||
5217|080|S|worse, tell your doctor or pharmacist promptly.||
5217|081|S|   Remember that this medication has been prescribed because your||
5217|082|S|doctor has judged that the benefit to you is greater than the||
5217|083|S|risk of side effects. Many people using this medication do not||
5217|084|S|have serious side effects.||
5217|085|S|   Tell your doctor right away if you have any serious side||
5217|086|S|effects, including: shakiness (tremor), swelling ankles/feet,||
5217|087|S|tingling/numbness, shortness of breath, fast heartbeat.||
5217|088|S|   A small number of people who take anticonvulsants for any||
5217|089|S|condition (such as seizure, bipolar disorder, pain) may||
5217|090|S|experience depression, suicidal thoughts/attempts, or other||
5217|091|S|mental/mood problems. Tell your doctor right away if you or your||
5217|092|S|family/caregiver notice any unusual/sudden changes in your mood,||
5217|093|S|thoughts, or behavior including signs of depression, suicidal||
5217|094|S|thoughts/attempts, thoughts about harming yourself.||
5217|095|S|   A very serious allergic reaction to this drug is rare.||
5217|096|S|However, get medical help right away if you notice any symptoms||
5217|097|S|of a serious allergic reaction, including: rash, itching/swelling||
5217|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5217|099|S|breathing.||
5217|100|S|   This is not a complete list of possible side effects. If you||
5217|101|S|notice other effects not listed above, contact your doctor or||
5217|102|S|pharmacist.||
5217|103|S|   In the US -||
5217|104|S|   Call your doctor for medical advice about side effects. You||
5217|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5217|106|S|www.fda.gov/medwatch.||
5217|107|S|   In Canada - Call your doctor for medical advice about side||
5217|108|S|effects. You may report side effects to Health Canada at||
5217|109|S|1-866-234-2345.||
5217|110|B|||
5217|111|P|PRECAUTIONS:  Before taking vigabatrin, tell your doctor or||
5217|112|P|pharmacist if you are allergic to it; or if you have any other||
5217|113|P|allergies. This product may contain inactive ingredients, which||
5217|114|P|can cause allergic reactions or other problems. Talk to your||
5217|115|P|pharmacist for more details.||
5217|116|P|   Before using this medication, tell your doctor or pharmacist||
5217|117|P|your medical history, especially of: eye problems (such as visual||
5217|118|P|field defect, glaucoma, macular degeneration, optic nerve||
5217|119|P|problem), mental/mood problems (such as depression, psychosis),||
5217|120|P|kidney disease, low red blood cell count (anemia).||
5217|121|P|   This drug may make you dizzy or drowsy or cause vision||
5217|122|P|problems. Alcohol or marijuana (cannabis) can make you more dizzy||
5217|123|P|or drowsy. Do not drive, use machinery, or do anything that needs||
5217|124|P|alertness or clear vision until you can do it safely. Avoid||
5217|125|P|alcoholic beverages. Talk to your doctor if you are using||
5217|126|P|marijuana (cannabis).||
5217|127|P|   MRI tests of the brain in infants have shown changes after||
5217|128|P|they are given vigabatrin. It is not known if these changes are||
5217|129|P|harmful. Consult your doctor for more details. If your infant is||
5217|130|P|going to have an MRI test, notify testing personnel that your||
5217|131|P|infant is using this medication.||
5217|132|P|   Before having surgery, tell your doctor or dentist about all||
5217|133|P|the products you use (including prescription drugs,||
5217|134|P|nonprescription drugs, and herbal products).||
5217|135|P|   Older adults may be at greater risk for side effects (such as||
5217|136|P|confusion) while using this drug. Confusion can increase the risk||
5217|137|P|of falling.||
5217|138|P|   Tell your doctor if you are pregnant or plan to become||
5217|139|P|pregnant. You should not become pregnant while using vigabatrin.||
5217|140|P|Vigabatrin may harm an unborn baby. Ask about reliable forms of||
5217|141|P|birth control while using this medication. If you become||
5217|142|P|pregnant, talk to your doctor right away about the risks and||
5217|143|P|benefits of this medication.||
5217|144|P|   This medication passes into breast milk in small amounts.||
5217|145|P|Consult your doctor before breastfeeding.||
5217|146|B|||
5217|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5217|148|I|medications work or increase your risk for serious side effects.||
5217|149|I|This document does not contain all possible drug interactions.||
5217|150|I|Keep a list of all the products you use (including||
5217|151|I|prescription/nonprescription drugs and herbal products) and share||
5217|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
5217|153|I|the dosage of any medicines without your doctor's approval.||
5217|154|I|   Some products that may interact with this drug include: drugs||
5217|155|I|that can harm the eye (retinotoxic drugs such as chloroquine,||
5217|156|I|hydroxychloroquine, phenothiazines including thioridazine),||
5217|157|I|orlistat.||
5217|158|I|   Tell your doctor or pharmacist if you are taking other||
5217|159|I|products that cause drowsiness including alcohol, marijuana||
5217|160|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
5217|161|I|drugs for sleep or anxiety (such as alprazolam, clonazepam,||
5217|162|I|diazepam, zolpidem), muscle relaxants, and opioid pain relievers||
5217|163|I|(such as codeine).||
5217|164|I|   Check the labels on all your medicines (such as allergy or||
5217|165|I|cough-and-cold products) because they may contain ingredients||
5217|166|I|that cause drowsiness. Ask your pharmacist about using those||
5217|167|I|products safely.||
5217|168|I|   This medication may interfere with certain lab tests (such as||
5217|169|I|liver function tests), possibly causing false test results. Make||
5217|170|I|sure lab personnel and all your doctors know you use this drug.||
5217|171|B|||
5217|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5217|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5217|174|O|poison control center right away. US residents can call||
5217|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5217|176|O|Symptoms of overdose may include: slow/shallow breathing, loss of||
5217|177|O|consciousness.||
5217|178|B|||
5217|179|N|NOTES:  Do not share this medication with others.||
5217|180|N|   Lab and/or medical tests (such as eye exams, kidney function,||
5217|181|N|complete blood count) should be done while you are taking this||
5217|182|N|medication. Keep all medical and lab appointments. Consult your||
5217|183|N|doctor for more details.||
5217|184|B|||
5217|185|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5217|186|D|remember. If it is near the time of the next dose, skip the||
5217|187|D|missed dose. Take your next dose at the regular time. Do not||
5217|188|D|double the dose to catch up.||
5217|189|B|||
5217|190|R|STORAGE:  Store at room temperature away from light and moisture.||
5217|191|R|Do not store in the bathroom. Do not open the packets until you||
5217|192|R|are ready to use the medication. Keep all medications away from||
5217|193|R|children and pets.||
5217|194|R|   Do not flush medications down the toilet or pour them into a||
5217|195|R|drain unless instructed to do so. Properly discard this product||
5217|196|R|when it is expired or no longer needed. Consult your pharmacist||
5217|197|R|or local waste disposal company.||
5217|198|B|||
5217|199|M|MEDICAL ALERT:  Your condition can cause complications in a||
5217|200|M|medical emergency. For information about enrolling in MedicAlert,||
5217|201|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5217|202|B|||
5217|203|A|Information last revised November 2024.||
5217|204|A|Copyright(c) 2025 First Databank, Inc.||
5217|205|B|||
5221|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5221|002|Z|does NOT have all possible information about this product. This||
5221|003|Z|information does not assure that this product is safe, effective,||
5221|004|Z|or appropriate for you. This information is not individual||
5221|005|Z|medical advice and does not substitute for the advice of your||
5221|006|Z|health care professional. Always ask your health care||
5221|007|Z|professional for complete information about this product and your||
5221|008|Z|specific health needs.||
5221|009|B|||
5221|010|T|METHENAMINE MANDELATE/SODIUM ACID PHOSPHATE - ORAL||
5221|011|F|(meth-EN-uh-meen MAN-duh-late/SO-dee-um FOSS-fate)||
5221|012|B|||
5221|013|C|COMMON BRAND NAME(S): Uroqid-Acid No.2||
5221|014|B|||
5221|015|U|USES:  This medication is used to prevent or control returning||
5221|016|U|urinary tract infections caused by certain bacteria. It is not||
5221|017|U|used to treat an active infection. Antibiotics must be used first||
5221|018|U|to treat and cure the infection. Methenamine is a drug that stops||
5221|019|U|the growth of bacteria in urine. Sodium acid phosphate helps to||
5221|020|U|make the urine acidic. When the urine is acidic, methenamine||
5221|021|U|turns into formaldehyde to kill the bacteria.||
5221|022|U|   This drug is effective only against bacterial infections in||
5221|023|U|the urinary tract. It will not work for other types of bacterial||
5221|024|U|infections (such as in the blood) or for viral infections (such||
5221|025|U|as the common cold or flu). Unnecessary use or misuse of any||
5221|026|U|antibacterial drug can lead to its decreased effectiveness.||
5221|027|B|||
5221|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
5221|029|H|doctor, usually 4 times daily at the beginning of treatment, then||
5221|030|H|2 to 4 times daily. Take with a full glass (8 ounces or 240||
5221|031|H|milliliters) of water. The dosage is based on your medical||
5221|032|H|condition and response to treatment.||
5221|033|H|   Methenamine works better if your urine is more acidic. Your||
5221|034|H|doctor may test the acidity of your urine (urine pH). If||
5221|035|H|necessary, your doctor may recommend ways to increase urine||
5221|036|H|acidity (such as by taking vitamin C/drinking cranberry juice,||
5221|037|H|limiting foods that decrease acidity/increase alkalinity such as||
5221|038|H|milk products/most fruits, adjusting alkalinizing medications).||
5221|039|H|See also Drug Interactions section. Follow your doctor's||
5221|040|H|instructions.||
5221|041|H|   For the best effect, take this drug at evenly spaced times. To||
5221|042|H|help you remember, take this medication at the same time(s) every||
5221|043|H|day.||
5221|044|H|   Tell your doctor if symptoms of a urinary tract infection||
5221|045|H|return (such as burning/painful/frequent urination).||
5221|046|B|||
5221|047|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, abdominal cramps, and||
5221|048|S|loss of appetite may occur. If any of these effects last or get||
5221|049|S|worse, tell your doctor or pharmacist promptly.||
5221|050|S|   Painful or difficult urination may occur with this medication,||
5221|051|S|although less often. Report these side effects to your doctor,||
5221|052|S|who may need to lower your dose of this medication or change your||
5221|053|S|treatment to make your urine less acidic.||
5221|054|S|   Remember that this medication has been prescribed because your||
5221|055|S|doctor has judged that the benefit to you is greater than the||
5221|056|S|risk of side effects. Many people using this medication do not||
5221|057|S|have serious side effects.||
5221|058|S|   Taking higher than recommended doses of methenamine may cause||
5221|059|S|bladder irritation, painful/frequent urination, and bloody/pink||
5221|060|S|urine. Tell your doctor right away if you have any of these||
5221|061|S|symptoms.||
5221|062|S|   Tell your doctor right away if you have any serious side||
5221|063|S|effects, including: vomiting that doesn't stop, mouth sores,||
5221|064|S|unusual headache, ringing in the ears, muscle cramps, swelling of||
5221|065|S|the arms/legs/feet, shortness of breath, confusion, bone/joint||
5221|066|S|pain, dizziness, seizures, unusual tiredness/weakness,||
5221|067|S|numbness/tingling/pain/weakness of hands/feet/legs,||
5221|068|S|numbness/tingling around lips, fast/irregular heartbeat, unusual||
5221|069|S|weight gain, signs of kidney problems (such as change in the||
5221|070|S|amount of urine), unusual thirst.||
5221|071|S|   A very serious allergic reaction to this drug is rare.||
5221|072|S|However, get medical help right away if you notice any symptoms||
5221|073|S|of a serious allergic reaction, including: rash, itching/swelling||
5221|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5221|075|S|breathing.||
5221|076|S|   This is not a complete list of possible side effects. If you||
5221|077|S|notice other effects not listed above, contact your doctor or||
5221|078|S|pharmacist.||
5221|079|S|   In the US -||
5221|080|S|   Call your doctor for medical advice about side effects. You||
5221|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5221|082|S|www.fda.gov/medwatch.||
5221|083|S|   In Canada - Call your doctor for medical advice about side||
5221|084|S|effects. You may report side effects to Health Canada at||
5221|085|S|1-866-234-2345.||
5221|086|B|||
5221|087|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
5221|088|P|pharmacist if you are allergic to methenamine or sodium acid||
5221|089|P|phosphate; or to formaldehyde; or if you have any other||
5221|090|P|allergies. This product may contain inactive ingredients, which||
5221|091|P|can cause allergic reactions or other problems. Talk to your||
5221|092|P|pharmacist for more details.||
5221|093|P|   Before using this medication, tell your doctor or pharmacist||
5221|094|P|your medical history, especially of: kidney problems, liver||
5221|095|P|problems, dehydration, high blood levels of certain minerals||
5221|096|P|(sodium or phosphate), heart failure, swelling of ankles/feet,||
5221|097|P|fluid in the lungs (pulmonary edema), high blood pressure, high||
5221|098|P|blood pressure during pregnancy, parathyroid problems, disease of||
5221|099|P|the pancreas (pancreatitis), metabolic imbalance (metabolic||
5221|100|P|acidosis).||
5221|101|P|   This product contains a large amount of sodium. It should be||
5221|102|P|used with caution if you are on a low-sodium diet.||
5221|103|P|   Before having surgery, tell your doctor or dentist about all||
5221|104|P|the products you use (including prescription drugs,||
5221|105|P|nonprescription drugs, and herbal products).||
5221|106|P|   During pregnancy, this medication should be used only when||
5221|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
5221|108|P|   This drug passes into breast milk and the effect on a nursing||
5221|109|P|infant is unknown. Consult your doctor before breastfeeding.||
5221|110|B|||
5221|111|I|DRUG INTERACTIONS:  See also How to Use section.||
5221|112|I|   Drug interactions may change how your medications work or||
5221|113|I|increase your risk for serious side effects. This document does||
5221|114|I|not contain all possible drug interactions. Keep a list of all||
5221|115|I|the products you use (including prescription/nonprescription||
5221|116|I|drugs and herbal products) and share it with your doctor and||
5221|117|I|pharmacist. Do not start, stop, or change the dosage of any||
5221|118|I|medicines without your doctor's approval.||
5221|119|I|   Some products that may interact with this drug include:||
5221|120|I|burosumab, sulfonamide drugs (including sulfa antibiotics such as||
5221|121|I|sulfamethizole), corticosteroids (such as corticotropin,||
5221|122|I|fludrocortisone), products that decrease the amount of acid in||
5221|123|I|the urine (urinary alkalinizers such as antacids, sodium||
5221|124|I|bicarbonate, potassium or sodium citrate, carbonic anhydrase||
5221|125|I|inhibitors such as acetazolamide).||
5221|126|I|   Antacids containing aluminum, calcium, or magnesium can also||
5221|127|I|bind to phosphate, which can cause this drug to be less||
5221|128|I|effective.||
5221|129|I|   This medication when used with salicylates (such as high doses||
5221|130|I|of aspirin) may lead to increased blood salicylate levels and||
5221|131|I|possible side effects. If you are taking high doses of||
5221|132|I|salicylates, tell your doctor so your treatment can be adjusted.||
5221|133|I|If your doctor has told you to take low-dose aspirin to prevent||
5221|134|I|heart attack or stroke (usually 81-162 milligrams a day), you||
5221|135|I|should keep taking the aspirin unless your doctor tells you not||
5221|136|I|to. Ask your doctor or pharmacist for more details.||
5221|137|I|   This medication may interfere with certain lab tests, possibly||
5221|138|I|causing false test results. Make sure lab personnel and all your||
5221|139|I|doctors know you use this drug.||
5221|140|B|||
5221|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5221|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5221|143|O|poison control center right away. US residents can call||
5221|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5221|145|B|||
5221|146|N|NOTES:  Do not share this medication with others.||
5221|147|N|   Lab and/or medical tests (such as urine tests, kidney/liver||
5221|148|N|function, blood mineral levels) should be done while you are||
5221|149|N|taking this medication. Keep all medical and lab appointments.||
5221|150|N|Consult your doctor for more details.||
5221|151|N|   This medication has been prescribed for your current condition||
5221|152|N|only. Do not use it later for another infection unless your||
5221|153|N|doctor tells you to.||
5221|154|B|||
5221|155|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5221|156|D|remember. If it is near the time of the next dose, skip the||
5221|157|D|missed dose. Take your next dose at the regular time. Do not||
5221|158|D|double the dose to catch up.||
5221|159|B|||
5221|160|R|STORAGE:  Store at room temperature away from light and moisture.||
5221|161|R|Do not store in the bathroom. Keep all medications away from||
5221|162|R|children and pets.||
5221|163|R|   Do not flush medications down the toilet or pour them into a||
5221|164|R|drain unless instructed to do so. Properly discard this product||
5221|165|R|when it is expired or no longer needed. Consult your pharmacist||
5221|166|R|or local waste disposal company.||
5221|167|B|||
5221|168|A|Information last revised November 2025.||
5221|169|A|Copyright(c) 2025 First Databank, Inc.||
5221|170|B|||
5222|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5222|002|Z|does NOT have all possible information about this product. This||
5222|003|Z|information does not assure that this product is safe, effective,||
5222|004|Z|or appropriate for you. This information is not individual||
5222|005|Z|medical advice and does not substitute for the advice of your||
5222|006|Z|health care professional. Always ask your health care||
5222|007|Z|professional for complete information about this product and your||
5222|008|Z|specific health needs.||
5222|009|B|||
5222|010|T|IPRATROPIUM SOLUTION - INHALATION||
5222|011|F|(IP-ra-TROE-pee-um)||
5222|012|B|||
5222|013|C|COMMON BRAND NAME(S): Atrovent||
5222|014|B|||
5222|015|U|USES:  Ipratropium is used to control and prevent symptoms||
5222|016|U|(wheezing and shortness of breath) caused by ongoing lung disease||
5222|017|U|(chronic obstructive pulmonary disease-COPD which includes||
5222|018|U|bronchitis and emphysema). It works by relaxing the muscles||
5222|019|U|around the airways so that they open up and you can breathe more||
5222|020|U|easily. Controlling symptoms of breathing problems can decrease||
5222|021|U|time lost from work or school.||
5222|022|U|   For preventing symptoms of lung disease, this medication must||
5222|023|U|be used regularly to be effective. Use your quick-relief inhaler||
5222|024|U|or nebulized solution (such as albuterol, also called salbutamol||
5222|025|U|in some countries) for wheezing or sudden shortness of breath||
5222|026|U|unless otherwise directed by your doctor. Ipratropium does not||
5222|027|U|work as fast as your quick-relief medication, but may sometimes||
5222|028|U|be used together with your quick-relief medication to relieve||
5222|029|U|symptoms of wheezing or sudden shortness of breath if so||
5222|030|U|prescribed by your doctor.||
5222|031|B|||
5222|032|V|OTHER USES:  This section contains uses of this drug that are not||
5222|033|V|listed in the approved professional labeling for the drug but||
5222|034|V|that may be prescribed by your health care professional. Use this||
5222|035|V|drug for a condition that is listed in this section only if it||
5222|036|V|has been so prescribed by your health care professional.||
5222|037|V|   This drug may also be used to control symptoms (such as||
5222|038|V|wheezing and sudden shortness of breath) caused by asthma.||
5222|039|B|||
5222|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5222|041|H|from your pharmacist before you start using ipratropium and each||
5222|042|H|time you get a refill. This medication is used with a special||
5222|043|H|machine called a nebulizer that changes the solution to a fine||
5222|044|H|mist that you inhale. Learn how to prepare the solution and use||
5222|045|H|the nebulizer properly. If a child is using this medication, a||
5222|046|H|parent or other responsible adult should supervise the child. If||
5222|047|H|you have any questions, ask your doctor, pharmacist, or||
5222|048|H|respiratory therapist.||
5222|049|H|   This product should be clear and colorless. Before using,||
5222|050|H|check this product for particles or discoloration. If either is||
5222|051|H|present, do not use the liquid.||
5222|052|H|   Inhale this medication into your lungs using the nebulizer as||
5222|053|H|directed by your doctor, usually 3 to 4 times a day (6 to 8 hours||
5222|054|H|apart). Avoid getting this medication into your eyes. It may||
5222|055|H|cause eye pain/irritation, temporary blurred vision, and other||
5222|056|H|vision changes. It is recommended that you use a mouthpiece||
5222|057|H|rather than a face mask with the nebulizer or that you close your||
5222|058|H|eyes during use. Each treatment usually takes about 5 to 15||
5222|059|H|minutes. Use this medication only through a nebulizer. Do not||
5222|060|H|swallow or inject the solution. To prevent infections, clean the||
5222|061|H|nebulizer and mouthpiece/face mask according to the||
5222|062|H|manufacturer's directions.||
5222|063|H|   Rinse your mouth after treatment to prevent dry mouth and||
5222|064|H|throat irritation.||
5222|065|H|   Ipratropium may be mixed with other medications (such as||
5222|066|H|albuterol) or saline if directed by your doctor. Follow your||
5222|067|H|doctor's instructions carefully. Once a vial is opened, throw||
5222|068|H|away any unused solution.||
5222|069|H|   Dosage is based on your medical condition and response to||
5222|070|H|treatment.||
5222|071|H|   If you are directed to use this medication regularly, it works||
5222|072|H|best if used at evenly spaced intervals. To help you remember,||
5222|073|H|use it at the same times each day. Do not increase your dose, use||
5222|074|H|this medication more often, or stop using it without first||
5222|075|H|consulting your doctor.||
5222|076|H|   Tell your doctor if your symptoms do not get better or if they||
5222|077|H|get worse.||
5222|078|H|   Learn which of your inhalers/medications you should use every||
5222|079|H|day and which you should use if your breathing suddenly worsens||
5222|080|H|(quick-relief drugs). Ask your doctor ahead of time what you||
5222|081|H|should do if you have new or worsening cough or shortness of||
5222|082|H|breath, wheezing, increased sputum, waking up at night with||
5222|083|H|trouble breathing, if you use your quick-relief inhaler more||
5222|084|H|often, or if your quick-relief inhaler does not seem to be||
5222|085|H|working well. Learn when you can treat sudden breathing problems||
5222|086|H|by yourself and when you must get medical help right away.||
5222|087|B|||
5222|088|S|SIDE EFFECTS:  See also How to Use section.||
5222|089|S|   Dizziness, nausea, stomach upset, dry mouth, or constipation||
5222|090|S|may occur. If any of these effects last or get worse, tell your||
5222|091|S|doctor or pharmacist promptly.||
5222|092|S|   Remember that this medication has been prescribed because your||
5222|093|S|doctor has judged that the benefit to you is greater than the||
5222|094|S|risk of side effects. Many people using this medication do not||
5222|095|S|have serious side effects.||
5222|096|S|   Rarely, this medication may cause severe sudden worsening of||
5222|097|S|breathing problems right after use. If you have sudden worsening||
5222|098|S|of breathing, use your quick-relief medication and get medical||
5222|099|S|help right away.||
5222|100|S|   Tell your doctor right away if you have any serious side||
5222|101|S|effects, including: fast/pounding heartbeat, difficult/painful||
5222|102|S|urination.||
5222|103|S|   Get medical help right away if you have any very serious side||
5222|104|S|effects, including: eye pain/swelling/redness, vision changes||
5222|105|S|(such as seeing rainbows around lights at night, blurred vision).||
5222|106|S|   A very serious allergic reaction to this product is rare.||
5222|107|S|However, get medical help right away if you notice any symptoms||
5222|108|S|of a serious allergic reaction, including: rash, itching/swelling||
5222|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5222|110|S|breathing.||
5222|111|S|   This is not a complete list of possible side effects. If you||
5222|112|S|notice other effects not listed above, contact your doctor or||
5222|113|S|pharmacist.||
5222|114|S|   In the US -||
5222|115|S|   Call your doctor for medical advice about side effects. You||
5222|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5222|117|S|www.fda.gov/medwatch.||
5222|118|S|   In Canada - Call your doctor for medical advice about side||
5222|119|S|effects. You may report side effects to Health Canada at||
5222|120|S|1-866-234-2345.||
5222|121|B|||
5222|122|P|PRECAUTIONS:  Before using ipratropium, tell your doctor or||
5222|123|P|pharmacist if you are allergic to it or to tiotropium; or to||
5222|124|P|atropine or other belladonna-type drugs; or if you have any other||
5222|125|P|allergies. This product may contain inactive ingredients, which||
5222|126|P|can cause allergic reactions or other problems. Talk to your||
5222|127|P|pharmacist for more details.||
5222|128|P|   Before using this medication, tell your doctor or pharmacist||
5222|129|P|your medical history, especially of: personal or family history||
5222|130|P|of glaucoma (angle-closure type), difficulty urinating (for||
5222|131|P|example, due to enlarged prostate).||
5222|132|P|   This drug may make you dizzy or blur your vision or cause||
5222|133|P|vision changes. Alcohol or marijuana (cannabis) can make you more||
5222|134|P|dizzy. Do not drive, use machinery, or do anything that needs||
5222|135|P|alertness or clear vision until you can do it safely. Limit||
5222|136|P|alcoholic beverages. Talk to your doctor if you are using||
5222|137|P|marijuana (cannabis).||
5222|138|P|   Before having surgery, tell your doctor or dentist about all||
5222|139|P|the products you use (including prescription drugs,||
5222|140|P|nonprescription drugs, and herbal products).||
5222|141|P|   Older adults may be more sensitive to the side effects of this||
5222|142|P|drug, especially problems urinating or constipation.||
5222|143|P|   During pregnancy, this medication should be used only when||
5222|144|P|clearly needed. Discuss the risks and benefits with your doctor.||
5222|145|P|   It is unknown if this medication passes into breast milk.||
5222|146|P|Consult your doctor before breastfeeding.||
5222|147|B|||
5222|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5222|149|I|medications work or increase your risk for serious side effects.||
5222|150|I|This document does not contain all possible drug interactions.||
5222|151|I|Keep a list of all the products you use (including||
5222|152|I|prescription/nonprescription drugs and herbal products) and share||
5222|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
5222|154|I|the dosage of any medicines without your doctor's approval.||
5222|155|B|||
5222|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5222|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5222|158|O|poison control center right away. US residents can call||
5222|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5222|160|B|||
5222|161|N|NOTES:  Do not share this medication with others.||
5222|162|B|||
5222|163|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5222|164|D|If it is near the time of the next dose, skip the missed dose.||
5222|165|D|Use your next dose at the regular time. Do not double the dose to||
5222|166|D|catch up.||
5222|167|B|||
5222|168|R|STORAGE:  Store at room temperature away from light. Keep the||
5222|169|R|medication in the foil pouch until ready to use. Keep all||
5222|170|R|medications away from children and pets.||
5222|171|R|   Do not flush medications down the toilet or pour them into a||
5222|172|R|drain unless instructed to do so. Properly discard this product||
5222|173|R|when it is expired or no longer needed. Consult your pharmacist||
5222|174|R|or local waste disposal company.||
5222|175|B|||
5222|176|M|MEDICAL ALERT:  Your condition can cause complications in a||
5222|177|M|medical emergency. For information about enrolling in MedicAlert,||
5222|178|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5222|179|B|||
5222|180|A|Information last revised January 2025.||
5222|181|A|Copyright(c) 2025 First Databank, Inc.||
5222|182|B|||
5223|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5223|002|Z|does NOT have all possible information about this product. This||
5223|003|Z|information does not assure that this product is safe, effective,||
5223|004|Z|or appropriate for you. This information is not individual||
5223|005|Z|medical advice and does not substitute for the advice of your||
5223|006|Z|health care professional. Always ask your health care||
5223|007|Z|professional for complete information about this product and your||
5223|008|Z|specific health needs.||
5223|009|B|||
5223|010|T|AZITHROMYCIN SUSPENSION - ORAL||
5223|011|F|(ay-ZITH-roe-MYE-sin)||
5223|012|B|||
5223|013|C|COMMON BRAND NAME(S): Zithromax||
5223|014|B|||
5223|015|U|USES:  Azithromycin is used to treat a wide variety of bacterial||
5223|016|U|infections. It is a macrolide-type antibiotic. It works by||
5223|017|U|stopping the growth of bacteria.||
5223|018|U|   This medication will not work for viral infections (such as||
5223|019|U|common cold, flu). Unnecessary use or misuse of any antibiotic||
5223|020|U|can lead to its decreased effectiveness.||
5223|021|B|||
5223|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5223|023|H|from your pharmacist before you start taking azithromycin and||
5223|024|H|each time you get a refill. If you have any questions, ask your||
5223|025|H|doctor or pharmacist.||
5223|026|H|   Take this medication by mouth as directed by your doctor,||
5223|027|H|usually once daily with or without food. You may take this||
5223|028|H|medication with food if stomach upset occurs. The dosage is based||
5223|029|H|on your medical condition and response to treatment. Children's||
5223|030|H|dosage is also based on weight.||
5223|031|H|   Shake the suspension well before using. Carefully measure the||
5223|032|H|dose using a special measuring device/spoon. Do not use a||
5223|033|H|household spoon because you may not get the correct dose. If your||
5223|034|H|child vomits the 1-day treatment dose within 30 minutes, call||
5223|035|H|your doctor to see if you need to repeat the dose.||
5223|036|H|   For the best effect, take this antibiotic at evenly spaced||
5223|037|H|times. To help you remember, take this medication at the same||
5223|038|H|time(s) every day.||
5223|039|H|   Continue to take this medication until the full prescribed||
5223|040|H|amount is finished, even if symptoms disappear after a few days.||
5223|041|H|Stopping the medication too early may result in a return of the||
5223|042|H|infection.||
5223|043|H|   Tell your doctor if your condition lasts or gets worse.||
5223|044|B|||
5223|045|S|SIDE EFFECTS:  Stomach upset, diarrhea/loose stools, nausea,||
5223|046|S|vomiting, or abdominal pain may occur. If any of these effects||
5223|047|S|last or get worse, tell your doctor or pharmacist promptly.||
5223|048|S|   Remember that this medication has been prescribed because your||
5223|049|S|doctor has judged that the benefit to you is greater than the||
5223|050|S|risk of side effects. Many people using this medication do not||
5223|051|S|have serious side effects.||
5223|052|S|   Tell your doctor right away if you have any serious side||
5223|053|S|effects, including: hearing changes (such as decreased hearing,||
5223|054|S|deafness), eye problems (such as drooping eyelids, blurred||
5223|055|S|vision), difficulty speaking/swallowing, muscle weakness, signs||
5223|056|S|of liver problems (such as nausea/vomiting that doesn't stop,||
5223|057|S|unusual tiredness, severe stomach/abdominal pain, yellowing||
5223|058|S|eyes/skin, dark urine).||
5223|059|S|   Get medical help right away if you have any very serious side||
5223|060|S|effects, including: fast/irregular heartbeat, severe dizziness,||
5223|061|S|fainting.||
5223|062|S|   This medication may rarely cause a severe intestinal condition||
5223|063|S|due to a bacteria called C. difficile. This condition may occur||
5223|064|S|during treatment or weeks to months after treatment has stopped.||
5223|065|S|Tell your doctor right away if you develop: diarrhea that doesn't||
5223|066|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
5223|067|S|stool.||
5223|068|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
5223|069|S|products because they may make symptoms worse.||
5223|070|S|   Use of this medication for prolonged or repeated periods may||
5223|071|S|result in oral thrush or a new yeast infection. Contact your||
5223|072|S|doctor if you notice white patches in your mouth, a change in||
5223|073|S|vaginal discharge, or other new symptoms.||
5223|074|S|   A very serious allergic reaction to this drug is rare.||
5223|075|S|However, get medical help right away if you notice any symptoms||
5223|076|S|of a serious allergic reaction, including: fever that doesn't go||
5223|077|S|away, new or worsening lymph node swelling, rash,||
5223|078|S|itching/swelling (especially of the face/tongue/throat), severe||
5223|079|S|dizziness, trouble breathing.||
5223|080|S|   An allergic reaction to this medication may return even if you||
5223|081|S|stop the drug. If you have an allergic reaction, continue to||
5223|082|S|watch for any of the above symptoms for several days after your||
5223|083|S|last dose.||
5223|084|S|   This is not a complete list of possible side effects. If you||
5223|085|S|notice other effects not listed above, contact your doctor or||
5223|086|S|pharmacist.||
5223|087|S|   In the US -||
5223|088|S|   Call your doctor for medical advice about side effects. You||
5223|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5223|090|S|www.fda.gov/medwatch.||
5223|091|S|   In Canada - Call your doctor for medical advice about side||
5223|092|S|effects. You may report side effects to Health Canada at||
5223|093|S|1-866-234-2345.||
5223|094|B|||
5223|095|P|PRECAUTIONS:  Before taking azithromycin, tell your doctor or||
5223|096|P|pharmacist if you are allergic to it; or to other antibiotics||
5223|097|P|(such as erythromycin, clarithromycin, telithromycin); or if you||
5223|098|P|have any other allergies. This product may contain inactive||
5223|099|P|ingredients, which can cause allergic reactions or other||
5223|100|P|problems. Talk to your pharmacist for more details.||
5223|101|P|   Before using this medication, tell your doctor or pharmacist||
5223|102|P|your medical history, especially of: liver disease, kidney||
5223|103|P|disease, a certain muscle disease (myasthenia gravis).||
5223|104|P|   Azithromycin may cause a condition that affects the heart||
5223|105|P|rhythm (QT prolongation). QT prolongation can rarely cause||
5223|106|P|serious (rarely fatal) fast/irregular heartbeat and other||
5223|107|P|symptoms (such as severe dizziness, fainting) that need medical||
5223|108|P|attention right away.||
5223|109|P|   The risk of QT prolongation may be increased if you have||
5223|110|P|certain medical conditions or are taking other drugs that may||
5223|111|P|cause QT prolongation. Before using azithromycin, tell your||
5223|112|P|doctor or pharmacist of all the drugs you take and if you have||
5223|113|P|any of the following conditions: certain heart problems (heart||
5223|114|P|failure, slow heartbeat, QT prolongation in the EKG), family||
5223|115|P|history of certain heart problems (QT prolongation in the EKG,||
5223|116|P|sudden cardiac death).||
5223|117|P|   Low levels of potassium or magnesium in the blood may also||
5223|118|P|increase your risk of QT prolongation. This risk may increase if||
5223|119|P|you use certain drugs (such as diuretics/"water pills") or if you||
5223|120|P|have conditions such as severe sweating, diarrhea, or vomiting.||
5223|121|P|Talk to your doctor about using azithromycin safely.||
5223|122|P|   Azithromycin may cause live bacterial vaccines (such as||
5223|123|P|typhoid vaccine) to not work well. Tell your health care||
5223|124|P|professional that you are using azithromycin before having any||
5223|125|P|immunizations/vaccinations.||
5223|126|P|   Before having surgery, tell your doctor or dentist about all||
5223|127|P|the products you use (including prescription drugs,||
5223|128|P|nonprescription drugs, and herbal products).||
5223|129|P|   Older adults may be more sensitive to the side effects of this||
5223|130|P|drug, especially QT prolongation (see above).||
5223|131|P|   Babies (especially younger than 6 weeks) may be at higher risk||
5223|132|P|for a certain serious stomach problem. Contact your child's||
5223|133|P|doctor right away if your child vomits or becomes irritable with||
5223|134|P|feeding.||
5223|135|P|   During pregnancy, this medication should be used only when||
5223|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
5223|137|P|   This drug passes into breast milk. Consult your doctor before||
5223|138|P|breastfeeding.||
5223|139|B|||
5223|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5223|141|I|medications work or increase your risk for serious side effects.||
5223|142|I|This document does not contain all possible drug interactions.||
5223|143|I|Keep a list of all the products you use (including||
5223|144|I|prescription/nonprescription drugs and herbal products) and share||
5223|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
5223|146|I|the dosage of any medicines without your doctor's approval.||
5223|147|I|   This medication can slow down the removal of other medications||
5223|148|I|from your body, which may affect how they work. Examples of||
5223|149|I|affected drugs include colchicine, among others.||
5223|150|I|   Many drugs besides azithromycin may affect the heart rhythm||
5223|151|I|(QT prolongation), including amiodarone, chloroquine,||
5223|152|I|disopyramide, dofetilide, dronedarone, hydroxychloroquine,||
5223|153|I|ibutilide, pimozide, procainamide, quinidine, sotalol, among||
5223|154|I|others.||
5223|155|B|||
5223|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5223|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5223|158|O|poison control center right away. US residents can call||
5223|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5223|160|B|||
5223|161|N|NOTES:  Do not share this medication with others.||
5223|162|N|   This medication has been prescribed for your current condition||
5223|163|N|only. Do not use it later for another infection unless your||
5223|164|N|doctor tells you to.||
5223|165|B|||
5223|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5223|167|D|remember. If it is near the time of the next dose, skip the||
5223|168|D|missed dose. Take your next dose at the regular time. Do not||
5223|169|D|double the dose to catch up.||
5223|170|B|||
5223|171|R|STORAGE:  Store at room temperature. Discard any unused portion||
5223|172|R|after 10 days. Keep all medications away from children and pets.||
5223|173|R|   Do not flush medications down the toilet or pour them into a||
5223|174|R|drain unless instructed to do so. Properly discard this product||
5223|175|R|when it is expired or no longer needed. Consult your pharmacist||
5223|176|R|or local waste disposal company.||
5223|177|B|||
5223|178|A|Information last revised December 2024.||
5223|179|A|Copyright(c) 2025 First Databank, Inc.||
5223|180|B|||
5224|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5224|002|Z|does NOT have all possible information about this product. This||
5224|003|Z|information does not assure that this product is safe, effective,||
5224|004|Z|or appropriate for you. This information is not individual||
5224|005|Z|medical advice and does not substitute for the advice of your||
5224|006|Z|health care professional. Always ask your health care||
5224|007|Z|professional for complete information about this product and your||
5224|008|Z|specific health needs.||
5224|009|B|||
5224|010|T|FLUPENTIXOL - ORAL||
5224|011|F|(flew-pen-TICK-sole)||
5224|012|B|||
5224|013|W|WARNING:  This medication may rarely cause a serious, possibly||
5224|014|W|fatal condition called neuroleptic malignant syndrome (NMS). Get||
5224|015|W|medical help right away if you have any of the following||
5224|016|W|symptoms: fever, muscle stiffness/pain/tenderness/weakness,||
5224|017|W|severe tiredness, severe confusion, sweating, fast/irregular||
5224|018|W|heartbeat, dark urine, signs of kidney problems (such as change||
5224|019|W|in the amount of urine).||
5224|020|W|   There may be a slightly increased risk of serious, possibly||
5224|021|W|fatal side effects (such as heart failure, fast/irregular||
5224|022|W|heartbeat, pneumonia) when this medication is used by older||
5224|023|W|adults with dementia. This medication is not approved for the||
5224|024|W|treatment of dementia-related behavior problems. Discuss the||
5224|025|W|risks and benefits of this medication, as well as other effective||
5224|026|W|and possibly safer treatments for dementia-related behavior||
5224|027|W|problems, with the doctor.||
5224|028|B|||
5224|029|U|USES:  This medication is used to treat certain mental/mood||
5224|030|U|disorders (such as schizophrenia, psychosis). Flupentixol belongs||
5224|031|U|to a class of drugs known as antipsychotics. It works by helping||
5224|032|U|to restore the balance of certain natural substances in the||
5224|033|U|brain.||
5224|034|B|||
5224|035|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5224|036|H|from your pharmacist before you start taking flupentixol and each||
5224|037|H|time you get a refill. If you have any questions, ask your doctor||
5224|038|H|or pharmacist.||
5224|039|H|   Take this medication by mouth with or without food as directed||
5224|040|H|by your doctor, usually 3 times daily.||
5224|041|H|   The dosage is based on your medical condition and response to||
5224|042|H|treatment. Your doctor will adjust your dose to find the best||
5224|043|H|dose for you. Your doctor may direct you to take a low dose at||
5224|044|H|first, increasing the dose gradually to lower the chance of side||
5224|045|H|effects such as stiff muscles. Follow your doctor's instructions||
5224|046|H|carefully.||
5224|047|H|   Take this medication regularly in order to get the most||
5224|048|H|benefit from it. To help you remember, take it at the same times||
5224|049|H|each day. This medication may not work right away. It may take 2||
5224|050|H|to 4 weeks before you get the full benefits.||
5224|051|H|   Do not stop taking this medication without consulting your||
5224|052|H|doctor. Your condition may become worse when the drug is suddenly||
5224|053|H|stopped. Your dose may need to be gradually decreased.||
5224|054|H|   Tell your doctor if your condition lasts or gets worse.||
5224|055|B|||
5224|056|S|SIDE EFFECTS:  See also Warning section.||
5224|057|S|   Drowsiness, dizziness, lightheadedness, restlessness, or||
5224|058|S|trouble sleeping may occur. If any of these effects last or get||
5224|059|S|worse, tell your doctor or pharmacist promptly.||
5224|060|S|   Dizziness and lightheadedness can increase the risk of||
5224|061|S|falling. Get up slowly when rising from a sitting or lying||
5224|062|S|position.||
5224|063|S|   Tell your doctor right away if any of these side effects||
5224|064|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
5224|065|S|mask-like expression of the face, drooling/trouble swallowing, or||
5224|066|S|shuffling walk. Your doctor may prescribe another medication to||
5224|067|S|decrease these side effects.||
5224|068|S|   Remember that this medication has been prescribed because your||
5224|069|S|doctor has judged that the benefit to you is greater than the||
5224|070|S|risk of side effects. Many people using this medication do not||
5224|071|S|have serious side effects.||
5224|072|S|   Tell your doctor right away if you have any serious side||
5224|073|S|effects, including: unusual mental/mood changes (such as||
5224|074|S|depression, mania, worsening of psychosis), difficult urination,||
5224|075|S|vision problems, signs of infection (such as sore throat that||
5224|076|S|doesn't go away, fever, chills), easy bruising/bleeding,||
5224|077|S|stomach/abdominal pain, yellowing eyes/skin, severe constipation.||
5224|078|S|   Rarely, this medication may increase your level of a certain||
5224|079|S|hormone (prolactin). For females, this effect may result in||
5224|080|S|unwanted breast milk, missing/stopped menstrual periods, or||
5224|081|S|difficulty becoming pregnant. For males, it may result in||
5224|082|S|decreased sexual ability, inability to produce sperm, or enlarged||
5224|083|S|breasts. If you develop any of these symptoms, tell your doctor||
5224|084|S|right away.||
5224|085|S|   Rarely, males may have a painful or prolonged erection lasting||
5224|086|S|4 or more hours. If this occurs, stop using this drug and get||
5224|087|S|medical help right away, or permanent problems could occur.||
5224|088|S|   This medication may rarely cause a condition known as tardive||
5224|089|S|dyskinesia. In some cases, this condition may be permanent. Tell||
5224|090|S|your doctor right away if you develop any unusual/uncontrolled||
5224|091|S|movements (especially of the face, mouth, tongue, arms, or legs).||
5224|092|S|   Get medical help right away if you have any very serious side||
5224|093|S|effects, including: chest pain, severe dizziness, fainting,||
5224|094|S|seizures.||
5224|095|S|   A very serious allergic reaction to this drug is rare.||
5224|096|S|However, get medical help right away if you notice any symptoms||
5224|097|S|of a serious allergic reaction, including: rash, itching/swelling||
5224|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5224|099|S|breathing.||
5224|100|S|   This is not a complete list of possible side effects. If you||
5224|101|S|notice other effects not listed above, contact your doctor or||
5224|102|S|pharmacist.||
5224|103|S|   In the US -||
5224|104|S|   Call your doctor for medical advice about side effects. You||
5224|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5224|106|S|www.fda.gov/medwatch.||
5224|107|S|   In Canada - Call your doctor for medical advice about side||
5224|108|S|effects. You may report side effects to Health Canada at||
5224|109|S|1-866-234-2345.||
5224|110|B|||
5224|111|P|PRECAUTIONS:  Before taking flupentixol, tell your doctor or||
5224|112|P|pharmacist if you are allergic to it; or to other thioxanthenes||
5224|113|P|(such as thiothixene, zuclopenthixol); or if you have any other||
5224|114|P|allergies. This product may contain inactive ingredients, which||
5224|115|P|can cause allergic reactions or other problems. Talk to your||
5224|116|P|pharmacist for more details.||
5224|117|P|   Before using this medication, tell your doctor or pharmacist||
5224|118|P|your medical history, especially of: blood problems (such as low||
5224|119|P|white blood cell count, anemia), high or low blood pressure,||
5224|120|P|brain problems (injury/tumor, confusion with difficulty staying||
5224|121|P|awake), blood flow problems (such as chest pain, heart attack,||
5224|122|P|stroke), breast cancer, glaucoma, slowed gut movement (such as||
5224|123|P|chronic constipation, ileus, blockage), kidney problems, liver||
5224|124|P|problems, Parkinson's disease, a certain adrenal gland tumor||
5224|125|P|(pheochromocytoma), seizures, difficulty urinating (such as due||
5224|126|P|to enlarged prostate), drug/alcohol dependency.||
5224|127|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5224|128|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5224|129|P|machinery, or do anything that needs alertness until you can do||
5224|130|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5224|131|P|are using marijuana (cannabis).||
5224|132|P|   Before having surgery, tell your doctor or dentist about all||
5224|133|P|the products you use (including prescription drugs,||
5224|134|P|nonprescription drugs, and herbal products).||
5224|135|P|   This medication may make you more sensitive to the sun. Limit||
5224|136|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5224|137|P|sunscreen and wear protective clothing when outdoors. Tell your||
5224|138|P|doctor right away if you get sunburned or have skin||
5224|139|P|blisters/redness.||
5224|140|P|   This medication may make you sweat less, making you more||
5224|141|P|likely to get heat stroke. Avoid doing things that may cause you||
5224|142|P|to overheat, such as hard work or exercise in hot weather, or||
5224|143|P|using hot tubs. When the weather is hot, drink a lot of fluids||
5224|144|P|and dress lightly. If you overheat, quickly look for a place to||
5224|145|P|cool down and rest. Get medical help right away if you have a||
5224|146|P|fever that does not go away, mental/mood changes, headache, or||
5224|147|P|dizziness.||
5224|148|P|   Avoid contact with certain pesticides (organophosphates).||
5224|149|P|   Flupentixol may cause a condition that affects the heart||
5224|150|P|rhythm (QT prolongation). QT prolongation can rarely cause||
5224|151|P|serious (rarely fatal) fast/irregular heartbeat and other||
5224|152|P|symptoms (such as severe dizziness, fainting) that need medical||
5224|153|P|attention right away.||
5224|154|P|   The risk of QT prolongation may be increased if you have||
5224|155|P|certain medical conditions or are taking other drugs that may||
5224|156|P|cause QT prolongation. Before using flupentixol, tell your doctor||
5224|157|P|or pharmacist of all the drugs you take and if you have any of||
5224|158|P|the following conditions: certain heart problems (heart failure,||
5224|159|P|slow heartbeat, QT prolongation in the EKG), family history of||
5224|160|P|certain heart problems (QT prolongation in the EKG, sudden||
5224|161|P|cardiac death).||
5224|162|P|   Low levels of potassium or magnesium in the blood may also||
5224|163|P|increase your risk of QT prolongation. This risk may increase if||
5224|164|P|you use certain drugs (such as diuretics/"water pills") or if you||
5224|165|P|have conditions such as severe sweating, diarrhea, or vomiting.||
5224|166|P|Talk to your doctor about using flupentixol safely.||
5224|167|P|   Older adults may be more sensitive to the side effects of this||
5224|168|P|drug, especially drowsiness, dizziness, lightheadedness, muscle||
5224|169|P|spasms/stiffness/twitching, uncontrolled movements (tardive||
5224|170|P|dyskinesia), and QT prolongation (see above). Drowsiness,||
5224|171|P|dizziness, and lightheadedness can increase the risk of falling.||
5224|172|P|   During pregnancy, this medication should be used only when||
5224|173|P|clearly needed. Babies born to mothers who have used this drug||
5224|174|P|during the last 3 months of pregnancy may rarely develop symptoms||
5224|175|P|including muscle stiffness or shakiness, drowsiness,||
5224|176|P|feeding/breathing difficulties, or constant crying. If you notice||
5224|177|P|any of these symptoms in your newborn especially during their||
5224|178|P|first month, tell the doctor right away.||
5224|179|P|   Since untreated mental/mood problems (such as schizophrenia,||
5224|180|P|psychosis) can be a serious condition, do not stop taking this||
5224|181|P|medication unless directed by your doctor. If you are planning||
5224|182|P|pregnancy, become pregnant, or think you may be pregnant,||
5224|183|P|immediately discuss with your doctor the benefits and risks of||
5224|184|P|using this medication during pregnancy.||
5224|185|P|   Flupentixol passes into breast milk and may harm a nursing||
5224|186|P|infant. Breastfeeding is not recommended while using this||
5224|187|P|medication. Consult your doctor before breastfeeding.||
5224|188|B|||
5224|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5224|190|I|medications work or increase your risk for serious side effects.||
5224|191|I|This document does not contain all possible drug interactions.||
5224|192|I|Keep a list of all the products you use (including||
5224|193|I|prescription/nonprescription drugs and herbal products) and share||
5224|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
5224|195|I|the dosage of any medicines without your doctor's approval.||
5224|196|I|   A product that may interact with this drug is: lithium.||
5224|197|I|   Many drugs besides flupentixol may affect the heart rhythm (QT||
5224|198|I|prolongation), including amiodarone, dofetilide, pimozide,||
5224|199|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
5224|200|I|erythromycin), among others.||
5224|201|I|   Tell your doctor or pharmacist if you are taking other||
5224|202|I|products that cause drowsiness such as opioid pain or cough||
5224|203|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5224|204|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5224|205|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5224|206|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5224|207|I|diphenhydramine).||
5224|208|I|   Check the labels on all your medicines (such as allergy or||
5224|209|I|cough-and-cold products) because they may contain ingredients||
5224|210|I|that cause drowsiness. Ask your pharmacist about using those||
5224|211|I|products safely.||
5224|212|B|||
5224|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5224|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5224|215|O|poison control center right away. US residents can call||
5224|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5224|217|O|Symptoms of overdose may include: loss of consciousness,||
5224|218|O|seizures, fast/irregular heartbeat, slow/shallow breathing.||
5224|219|B|||
5224|220|N|NOTES:  Do not share this medication with others.||
5224|221|N|   Lab and/or medical tests (such as liver function, complete||
5224|222|N|blood counts) may be done while you are taking this medication.||
5224|223|N|Keep all medical and lab appointments. Consult your doctor for||
5224|224|N|more details.||
5224|225|B|||
5224|226|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5224|227|D|remember. If it is less than 6 hours before the next dose, skip||
5224|228|D|the missed dose. Take your next dose at the regular time. Do not||
5224|229|D|double the dose to catch up.||
5224|230|B|||
5224|231|R|STORAGE:  Store at room temperature away from light and moisture.||
5224|232|R|Do not store in the bathroom. Keep all medications away from||
5224|233|R|children and pets.||
5224|234|R|   Do not flush medications down the toilet or pour them into a||
5224|235|R|drain unless instructed to do so. Properly discard this product||
5224|236|R|when it is expired or no longer needed. Consult your pharmacist||
5224|237|R|or local waste disposal company.||
5224|238|B|||
5224|239|A|Information last revised May 2025.||
5224|240|A|Copyright(c) 2025 First Databank, Inc.||
5224|241|B|||
5225|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5225|002|Z|does NOT have all possible information about this product. This||
5225|003|Z|information does not assure that this product is safe, effective,||
5225|004|Z|or appropriate for you. This information is not individual||
5225|005|Z|medical advice and does not substitute for the advice of your||
5225|006|Z|health care professional. Always ask your health care||
5225|007|Z|professional for complete information about this product and your||
5225|008|Z|specific health needs.||
5225|009|B|||
5225|010|T|NICARDIPINE - ORAL||
5225|011|F|(nye-KAR-di-peen)||
5225|012|B|||
5225|013|C|COMMON BRAND NAME(S): Cardene||
5225|014|B|||
5225|015|U|USES:  Nicardipine is used with or without other medications to||
5225|016|U|treat high blood pressure (hypertension). Lowering high blood||
5225|017|U|pressure helps prevent strokes, heart attacks, and kidney||
5225|018|U|problems. Nicardipine is called a calcium channel blocker. It||
5225|019|U|works by relaxing blood vessels so blood can flow more easily.||
5225|020|U|   Nicardipine is also used to prevent certain types of chest||
5225|021|U|pain (angina). It may help to increase your ability to exercise||
5225|022|U|and decrease the frequency of angina attacks. This medication||
5225|023|U|must be taken regularly to be effective. It should not be used to||
5225|024|U|treat attacks of chest pain when they occur. Use other||
5225|025|U|medications (such as sublingual nitroglycerin) to relieve attacks||
5225|026|U|of chest pain as directed by your doctor. Consult your doctor or||
5225|027|U|pharmacist for details.||
5225|028|B|||
5225|029|H|HOW TO USE:  Take this medication by mouth with or without food||
5225|030|H|as directed by your doctor, usually 3 times daily.||
5225|031|H|   The dosage is based on your medical condition and response to||
5225|032|H|treatment. Your doctor may gradually increase your dose. Follow||
5225|033|H|your doctor's instructions carefully.||
5225|034|H|   Use this medication regularly to get the most benefit from it.||
5225|035|H|To help you remember, take it at the same times each day. Keep||
5225|036|H|taking this medication even if you feel well. Most people with||
5225|037|H|high blood pressure do not feel sick.||
5225|038|H|   Tell your doctor if your condition does not get better or if||
5225|039|H|it gets worse (for example, your blood pressure readings remain||
5225|040|H|high or increase, your chest pain is more frequent or severe).||
5225|041|B|||
5225|042|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, flushing, or||
5225|043|S|swelling ankles/feet may occur. If any of these effects last or||
5225|044|S|get worse, tell your doctor or pharmacist promptly.||
5225|045|S|   To reduce the risk of dizziness and lightheadedness, get up||
5225|046|S|slowly when rising from a sitting or lying position.||
5225|047|S|   Remember that this medication has been prescribed because your||
5225|048|S|doctor has judged that the benefit to you is greater than the||
5225|049|S|risk of side effects. Many people using this medication do not||
5225|050|S|have serious side effects.||
5225|051|S|   Tell your doctor right away if you have any serious side||
5225|052|S|effects, including: fainting, fast/irregular/pounding heartbeat,||
5225|053|S|vision changes.||
5225|054|S|   Although this medication is effective in preventing chest pain||
5225|055|S|(angina), some people who already have severe heart disease may||
5225|056|S|rarely develop worsening chest pain or a heart attack after||
5225|057|S|starting this medication or increasing the dose. Get medical help||
5225|058|S|right away if you experience: worsening chest pain, symptoms of a||
5225|059|S|heart attack (such as chest/jaw/left arm pain, shortness of||
5225|060|S|breath, unusual sweating).||
5225|061|S|   A very serious allergic reaction to this drug is rare.||
5225|062|S|However, get medical help right away if you notice any symptoms||
5225|063|S|of a serious allergic reaction, including: rash, itching/swelling||
5225|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5225|065|S|breathing.||
5225|066|S|   This is not a complete list of possible side effects. If you||
5225|067|S|notice other effects not listed above, contact your doctor or||
5225|068|S|pharmacist.||
5225|069|S|   In the US -||
5225|070|S|   Call your doctor for medical advice about side effects. You||
5225|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5225|072|S|www.fda.gov/medwatch.||
5225|073|S|   In Canada - Call your doctor for medical advice about side||
5225|074|S|effects. You may report side effects to Health Canada at||
5225|075|S|1-866-234-2345.||
5225|076|B|||
5225|077|P|PRECAUTIONS:  Before taking nicardipine, tell your doctor or||
5225|078|P|pharmacist if you are allergic to it; or if you have any other||
5225|079|P|allergies. This product may contain inactive ingredients, which||
5225|080|P|can cause allergic reactions or other problems. Talk to your||
5225|081|P|pharmacist for more details.||
5225|082|P|   Before using this medication, tell your doctor or pharmacist||
5225|083|P|your medical history, especially of: a certain structural heart||
5225|084|P|problem (aortic stenosis), liver disease, kidney disease.||
5225|085|P|   Before having surgery, tell your doctor or dentist about all||
5225|086|P|the products you use (including prescription drugs,||
5225|087|P|nonprescription drugs, and herbal products).||
5225|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5225|089|P|can make you more dizzy. Do not drive, use machinery, or do||
5225|090|P|anything that needs alertness until you can do it safely. Limit||
5225|091|P|alcoholic beverages. Talk to your doctor if you are using||
5225|092|P|marijuana (cannabis).||
5225|093|P|   During pregnancy, this medication should be used only when||
5225|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
5225|095|P|   It is unknown if this drug passes into breast milk. Consult||
5225|096|P|your doctor before breastfeeding.||
5225|097|B|||
5225|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5225|099|I|medications work or increase your risk for serious side effects.||
5225|100|I|This document does not contain all possible drug interactions.||
5225|101|I|Keep a list of all the products you use (including||
5225|102|I|prescription/nonprescription drugs and herbal products) and share||
5225|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
5225|104|I|the dosage of any medicines without your doctor's approval.||
5225|105|I|   Other medications can affect the removal of nicardipine from||
5225|106|I|your body, which may affect how nicardipine works. Examples||
5225|107|I|include cimetidine, azole antifungals (such as itraconazole),||
5225|108|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
5225|109|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
5225|110|I|as phenytoin), among others.||
5225|111|I|   Some products have ingredients that could raise your heart||
5225|112|I|rate or blood pressure. Tell your pharmacist what products you||
5225|113|I|are using, and ask how to use them safely (especially||
5225|114|I|cough-and-cold products, diet aids, or NSAIDs such as||
5225|115|I|ibuprofen/naproxen).||
5225|116|B|||
5225|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5225|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5225|119|O|poison control center right away. US residents can call||
5225|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5225|121|B|||
5225|122|N|NOTES:  Do not share this medication with others.||
5225|123|N|   Talk with your doctor about making changes to your lifestyle||
5225|124|N|that may help this medication work better (such as stress||
5225|125|N|reduction programs, exercise, and dietary changes.)||
5225|126|N|   Lab and/or medical tests (such as liver function, blood||
5225|127|N|pressure, electrocardiograms) may be done while you are taking||
5225|128|N|this medication. Keep all medical and lab appointments. Consult||
5225|129|N|your doctor for more details.||
5225|130|N|   Check your blood pressure regularly while taking this||
5225|131|N|medication, especially when you first start this drug or when||
5225|132|N|your doctor changes your dose. Learn how to monitor your own||
5225|133|N|blood pressure at home, and share the results with your doctor.||
5225|134|B|||
5225|135|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5225|136|D|remember. If it is near the time of the next dose, skip the||
5225|137|D|missed dose. Take your next dose at the regular time. Do not||
5225|138|D|double the dose to catch up.||
5225|139|B|||
5225|140|R|STORAGE:  Store at room temperature away from light and moisture.||
5225|141|R|Do not store in the bathroom. Keep all medications away from||
5225|142|R|children and pets.||
5225|143|R|   Do not flush medications down the toilet or pour them into a||
5225|144|R|drain unless instructed to do so. Properly discard this product||
5225|145|R|when it is expired or no longer needed. Consult your pharmacist||
5225|146|R|or local waste disposal company.||
5225|147|B|||
5225|148|M|MEDICAL ALERT:  Your condition can cause complications in a||
5225|149|M|medical emergency. For information about enrolling in MedicAlert,||
5225|150|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5225|151|B|||
5225|152|A|Information last revised May 2024.||
5225|153|A|Copyright(c) 2025 First Databank, Inc.||
5225|154|B|||
5239|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5239|002|Z|does NOT have all possible information about this product. This||
5239|003|Z|information does not assure that this product is safe, effective,||
5239|004|Z|or appropriate for you. This information is not individual||
5239|005|Z|medical advice and does not substitute for the advice of your||
5239|006|Z|health care professional. Always ask your health care||
5239|007|Z|professional for complete information about this product and your||
5239|008|Z|specific health needs.||
5239|009|B|||
5239|010|T|TRAMADOL - ORAL||
5239|011|F|(TRAH-muh-dall)||
5239|012|B|||
5239|013|C|COMMON BRAND NAME(S): Qdolo, Ultram||
5239|014|B|||
5239|015|W|WARNING:  Tramadol has a risk for abuse and addiction, which can||
5239|016|W|lead to overdose and death. Tramadol may also cause severe,||
5239|017|W|possibly fatal, breathing problems. To lower your risk, your||
5239|018|W|doctor should have you take the smallest dose of tramadol that||
5239|019|W|works, and take it for the shortest possible time. See also How||
5239|020|W|to Use section for more information about addiction.||
5239|021|W|   Ask your doctor or pharmacist if you should have medication||
5239|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
5239|023|W|Teach your family or household members about the signs of an||
5239|024|W|opioid overdose and how to treat it.||
5239|025|W|   The risk for severe breathing problems is higher when you||
5239|026|W|start this medication and after a dose increase, or if you take||
5239|027|W|the wrong dose/strength. Taking this medication with alcohol or||
5239|028|W|other drugs that can cause drowsiness or breathing problems may||
5239|029|W|cause very serious side effects, including death. Also, other||
5239|030|W|medications can affect the removal of tramadol from your body,||
5239|031|W|which may affect how tramadol works. Be sure you know how to take||
5239|032|W|tramadol and what other drugs you should avoid taking with it.||
5239|033|W|See also Drug Interactions section. Get medical help right away||
5239|034|W|if any of these very serious side effects occur: slow/shallow||
5239|035|W|breathing, unusual lightheadedness, severe drowsiness/dizziness,||
5239|036|W|difficulty waking up.||
5239|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
5239|038|W|or abuse. If someone accidentally swallows this drug, get medical||
5239|039|W|help right away.||
5239|040|W|   Before using this medication, women of childbearing age should||
5239|041|W|talk with their doctor(s) about the risks and benefits. Tell your||
5239|042|W|doctor if you are pregnant or if you plan to become pregnant.||
5239|043|W|During pregnancy, this medication should be used only when||
5239|044|W|clearly needed. It may slightly increase the risk of birth||
5239|045|W|defects if used during the first two months of pregnancy. Also,||
5239|046|W|using it for a long time or in high doses near the expected||
5239|047|W|delivery date may harm the unborn baby. To lessen the risk, take||
5239|048|W|the smallest effective dose for the shortest possible time.||
5239|049|W|Babies born to mothers who use this drug for a long time may||
5239|050|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
5239|051|W|doctor right away if you notice any symptoms in your newborn baby||
5239|052|W|such as crying that doesn't stop, slow/shallow breathing,||
5239|053|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
5239|054|W|difficulty gaining weight.||
5239|055|W|   Children younger than 18 years should not use products that||
5239|056|W|contain tramadol. Some children are more sensitive to tramadol||
5239|057|W|and have had very serious (rarely fatal) breathing problems such||
5239|058|W|as slow/shallow breathing (see also Side Effects section). The||
5239|059|W|risk is greater in children who are obese or have breathing||
5239|060|W|problems, or after certain surgeries (including tonsil/adenoid||
5239|061|W|removal). Talk with your doctor or pharmacist about the risks and||
5239|062|W|benefits of this medication.||
5239|063|B|||
5239|064|U|USES:  See also Warning section.||
5239|065|U|   This medication is used to help relieve moderate to moderately||
5239|066|U|severe pain. Tramadol belongs to a class of drugs known as opioid||
5239|067|U|analgesics. It works in the brain to change how your body feels||
5239|068|U|and responds to pain.||
5239|069|B|||
5239|070|H|HOW TO USE:  Read the Medication Guide provided by your||
5239|071|H|pharmacist before you start taking tramadol and each time you get||
5239|072|H|a refill. If you have any questions, ask your doctor or||
5239|073|H|pharmacist.||
5239|074|H|   Take this medication by mouth as directed by your doctor,||
5239|075|H|usually up to every 4 to 6 hours as needed for pain relief. You||
5239|076|H|may take this drug with or without food. If you have nausea, it||
5239|077|H|may help to take this drug with food. Ask your doctor or||
5239|078|H|pharmacist about other ways to decrease nausea (such as lying||
5239|079|H|down for 1 to 2 hours with as little head movement as possible).||
5239|080|H|   If you are using the liquid form of this medication, carefully||
5239|081|H|measure the dose using a special measuring device/spoon. Do not||
5239|082|H|use a household spoon because you may not get the correct dose.||
5239|083|H|Ask your doctor or pharmacist if you are not sure how to check or||
5239|084|H|measure the dose.||
5239|085|H|   The dosage is based on your medical condition and response to||
5239|086|H|treatment. To reduce your risk of side effects, your doctor may||
5239|087|H|direct you to start this medication at a low dose and gradually||
5239|088|H|increase your dose. Follow your doctor's instructions carefully.||
5239|089|H|The maximum recommended dose is 400 milligrams per day. If you||
5239|090|H|are older than 75 years, the maximum recommended dose is 300||
5239|091|H|milligrams per day. Do not increase your dose, take the||
5239|092|H|medication more often, or take it for a longer time than||
5239|093|H|prescribed. Properly stop the medication when so directed.||
5239|094|H|   Pain medications work best if they are used as the first signs||
5239|095|H|of pain occur. If you wait until the pain has worsened, the||
5239|096|H|medication may not work as well.||
5239|097|H|   If you have ongoing pain (such as due to arthritis), your||
5239|098|H|doctor may direct you to also take long-acting opioid||
5239|099|H|medications. In that case, this medication might be used for||
5239|100|H|sudden (breakthrough) pain only as needed. Other pain relievers||
5239|101|H|(such as acetaminophen, ibuprofen) may also be prescribed. Ask||
5239|102|H|your doctor or pharmacist about using tramadol safely with other||
5239|103|H|drugs.||
5239|104|H|   Suddenly stopping this medication may cause withdrawal,||
5239|105|H|especially if you have used it for a long time or in high doses.||
5239|106|H|To prevent withdrawal, your doctor may lower your dose slowly.||
5239|107|H|Tell your doctor or pharmacist right away if you have any||
5239|108|H|withdrawal symptoms such as restlessness, mental/mood changes||
5239|109|H|(including anxiety, trouble sleeping, thoughts of suicide),||
5239|110|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
5239|111|H|aches, or sudden changes in behavior.||
5239|112|H|   When this medication is used for a long time, it may not work||
5239|113|H|as well. Talk with your doctor if this medication stops working||
5239|114|H|well.||
5239|115|H|   Though it helps many people, this medication may sometimes||
5239|116|H|cause addiction. This risk may be higher if you have a||
5239|117|H|mental/mood disorder or a substance use disorder (such as overuse||
5239|118|H|of or addiction to drugs/alcohol). Take this medication exactly||
5239|119|H|as prescribed to lower the risk of addiction. Ask your doctor or||
5239|120|H|pharmacist for more details.||
5239|121|H|   Tell your doctor if your pain does not get better or if it||
5239|122|H|gets worse, or if you have any new pain.||
5239|123|B|||
5239|124|S|SIDE EFFECTS:  See also Warning section.||
5239|125|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
5239|126|S|drowsiness, or headache may occur. Some of these side effects may||
5239|127|S|decrease after you have been using this medication for a while.||
5239|128|S|If any of these effects last or get worse, tell your doctor or||
5239|129|S|pharmacist promptly.||
5239|130|S|   To prevent constipation, eat dietary fiber, drink enough||
5239|131|S|water, and exercise. You may also need to take a laxative. Ask||
5239|132|S|your pharmacist which type of laxative is right for you.||
5239|133|S|   To reduce the risk of dizziness and lightheadedness, get up||
5239|134|S|slowly when rising from a sitting or lying position.||
5239|135|S|   Remember that this medication has been prescribed because your||
5239|136|S|doctor has judged that the benefit to you is greater than the||
5239|137|S|risk of side effects. Many people using this medication do not||
5239|138|S|have serious side effects.||
5239|139|S|   Tell your doctor right away if you have any serious side||
5239|140|S|effects, including: interrupted breathing during sleep (sleep||
5239|141|S|apnea), mental/mood changes (such as agitation, hallucinations),||
5239|142|S|severe stomach/abdominal pain, difficulty urinating, signs of||
5239|143|S|your adrenal glands not working well (such as loss of appetite,||
5239|144|S|unusual tiredness, weight loss), trouble swallowing.||
5239|145|S|   Get medical help right away if you have any very serious side||
5239|146|S|effects, including: fast/irregular heartbeat, severe dizziness,||
5239|147|S|fainting, seizure.||
5239|148|S|   This medication may increase serotonin and rarely cause a very||
5239|149|S|serious condition called serotonin syndrome/toxicity. The risk||
5239|150|S|increases if you are also taking other drugs that increase||
5239|151|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
5239|152|S|take (see Drug Interactions section). Get medical help right away||
5239|153|S|if you develop some of the following symptoms: fast heartbeat,||
5239|154|S|hallucinations, loss of coordination, severe dizziness, severe||
5239|155|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
5239|156|S|unusual agitation/restlessness.||
5239|157|S|   Tramadol is changed into a strong opioid drug in your body. In||
5239|158|S|some people, this change happens faster and more completely than||
5239|159|S|usual, which increases the risk of very serious side effects. Get||
5239|160|S|medical help right away if you notice any of the following:||
5239|161|S|slow/shallow breathing, severe drowsiness/difficulty waking up,||
5239|162|S|confusion.||
5239|163|S|   A very serious allergic reaction to this drug is rare.||
5239|164|S|However, get medical help right away if you notice any of the||
5239|165|S|following symptoms: rash, itching/swelling (especially of the||
5239|166|S|face/tongue/throat), severe dizziness, trouble breathing.||
5239|167|S|   This is not a complete list of possible side effects. If you||
5239|168|S|notice other effects not listed above, contact your doctor or||
5239|169|S|pharmacist.||
5239|170|S|   In the US -||
5239|171|S|   Call your doctor for medical advice about side effects. You||
5239|172|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5239|173|S|www.fda.gov/medwatch.||
5239|174|S|   In Canada - Call your doctor for medical advice about side||
5239|175|S|effects. You may report side effects to Health Canada at||
5239|176|S|1-866-234-2345.||
5239|177|B|||
5239|178|P|PRECAUTIONS:  Before taking tramadol, tell your doctor or||
5239|179|P|pharmacist if you are allergic to it; or if you have any other||
5239|180|P|allergies. This product may contain inactive ingredients, which||
5239|181|P|can cause allergic reactions or other problems. Talk to your||
5239|182|P|pharmacist for more details.||
5239|183|P|   Before using this medication, tell your doctor or pharmacist||
5239|184|P|your medical history, especially of: brain disorders (such as||
5239|185|P|head injury, tumor, seizures), breathing problems (such as||
5239|186|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
5239|187|P|kidney disease, liver disease, diabetes, mental/mood disorders||
5239|188|P|(such as confusion, depression, suicidal thoughts), personal or||
5239|189|P|family history of a substance use disorder (such as overuse of or||
5239|190|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
5239|191|P|blockage, constipation, diarrhea due to infection, paralytic||
5239|192|P|ileus), difficulty urinating (such as due to enlarged prostate),||
5239|193|P|gallbladder disease, disease of the pancreas (pancreatitis),||
5239|194|P|obesity.||
5239|195|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5239|196|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5239|197|P|machinery, or do anything that needs alertness until you can do||
5239|198|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5239|199|P|are using marijuana (cannabis).||
5239|200|P|   Tramadol may cause a condition that affects the heart rhythm||
5239|201|P|(QT prolongation). QT prolongation can rarely cause serious||
5239|202|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
5239|203|P|as severe dizziness, fainting) that need medical attention right||
5239|204|P|away.||
5239|205|P|   The risk of QT prolongation may be increased if you have||
5239|206|P|certain medical conditions or are taking other drugs that may||
5239|207|P|cause QT prolongation. Before using tramadol, tell your doctor or||
5239|208|P|pharmacist of all the drugs you take and if you have any of the||
5239|209|P|following conditions: certain heart problems (heart failure, slow||
5239|210|P|heartbeat, QT prolongation in the EKG), family history of certain||
5239|211|P|heart problems (QT prolongation in the EKG, sudden cardiac||
5239|212|P|death).||
5239|213|P|   Low levels of potassium or magnesium in the blood may also||
5239|214|P|increase your risk of QT prolongation. This risk may increase if||
5239|215|P|you use certain drugs (such as diuretics/"water pills") or if you||
5239|216|P|have conditions such as severe sweating, diarrhea, or vomiting.||
5239|217|P|Talk to your doctor about using tramadol safely.||
5239|218|P|   Liquid products may contain sugar and/or aspartame. Caution is||
5239|219|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
5239|220|P|condition that requires you to limit/avoid these substances in||
5239|221|P|your diet. Ask your doctor or pharmacist about using this product||
5239|222|P|safely.||
5239|223|P|   Before having surgery, tell your doctor or dentist about all||
5239|224|P|the products you use (including prescription drugs,||
5239|225|P|nonprescription drugs, and herbal products).||
5239|226|P|   Some children may be more sensitive to very serious side||
5239|227|P|effects of tramadol, such as extreme sleepiness, confusion, or||
5239|228|P|slow/shallow/noisy breathing. (See also Warning section.)||
5239|229|P|   Older adults may be more sensitive to the side effects of this||
5239|230|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
5239|231|P|breathing, and QT prolongation (see above). Older adults may also||
5239|232|P|be more likely to develop a type of salt imbalance (hyponatremia)||
5239|233|P|while using this drug.||
5239|234|P|   During pregnancy, this medication should be used only when||
5239|235|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
5239|236|P|benefits with your doctor. (See also Warning section.)||
5239|237|P|   This medication passes into breast milk and may have||
5239|238|P|undesirable effects on a nursing infant (such as unusual||
5239|239|P|sleepiness, difficulty feeding, or trouble breathing).||
5239|240|P|Breastfeeding is not recommended while using this medication.||
5239|241|P|Consult your doctor before breastfeeding.||
5239|242|B|||
5239|243|I|DRUG INTERACTIONS:  See also Warning section.||
5239|244|I|   Drug interactions may change how your medications work or||
5239|245|I|increase your risk for serious side effects. This document does||
5239|246|I|not contain all possible drug interactions. Keep a list of all||
5239|247|I|the products you use (including prescription/nonprescription||
5239|248|I|drugs and herbal products) and share it with your doctor and||
5239|249|I|pharmacist. Do not start, stop, or change the dosage of any||
5239|250|I|medicines without your doctor's approval.||
5239|251|I|   Some products that may interact with this drug include:||
5239|252|I|certain pain medications (mixed opioid agonist-antagonists such||
5239|253|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
5239|254|I|samidorphan.||
5239|255|I|   Taking MAO inhibitors with this medication may cause a serious||
5239|256|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
5239|257|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
5239|258|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
5239|259|I|selegiline, tranylcypromine) during treatment with this||
5239|260|I|medication. Most MAO inhibitors should also not be taken for two||
5239|261|I|weeks before treatment with this medication. Ask your doctor when||
5239|262|I|to start or stop taking this medication.||
5239|263|I|   The risk of serotonin syndrome/toxicity increases if you are||
5239|264|I|also taking other drugs that increase serotonin. Examples include||
5239|265|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
5239|266|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
5239|267|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
5239|268|I|serotonin syndrome/toxicity may be more likely when you start or||
5239|269|I|increase the dose of these drugs.||
5239|270|I|   Other medications can affect the removal of tramadol from your||
5239|271|I|body, which may affect how tramadol works. Examples include azole||
5239|272|I|antifungals (such as itraconazole), macrolide antibiotics (such||
5239|273|I|as erythromycin), quinidine, rifamycins (such as rifampin),||
5239|274|I|ritonavir, drugs used to treat seizures (such as carbamazepine),||
5239|275|I|among others.||
5239|276|I|   The risk of serious side effects (such as slow/shallow||
5239|277|I|breathing, severe drowsiness/dizziness) may be increased if this||
5239|278|I|medication is taken with other products that may also cause||
5239|279|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5239|280|I|if you are taking other products such as other opioid pain or||
5239|281|I|cough relievers (such as codeine, hydrocodone), alcohol,||
5239|282|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
5239|283|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
5239|284|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
5239|285|I|cetirizine, diphenhydramine).||
5239|286|I|   Check the labels on all your medicines (such as allergy or||
5239|287|I|cough-and-cold products) because they may contain ingredients||
5239|288|I|that cause drowsiness. Ask your pharmacist about using those||
5239|289|I|products safely.||
5239|290|I|   This medication may interfere with certain lab tests (such as||
5239|291|I|amylase/lipase levels), possibly causing false test results. Make||
5239|292|I|sure lab personnel and all your doctors know you use this drug.||
5239|293|B|||
5239|294|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5239|295|O|as passing out or trouble breathing, give them naloxone or||
5239|296|O|nalmefene if available, then call 911. If the person is awake and||
5239|297|O|has no symptoms, call a poison control center right away. US||
5239|298|O|residents can call 1-800-222-1222. Canada residents can call||
5239|299|O|1-844-764-7669. Symptoms of overdose may include: slow breathing,||
5239|300|O|slow/irregular heartbeat, coma, seizure.||
5239|301|B|||
5239|302|N|NOTES:  Do not share this medication with others. Sharing it is||
5239|303|N|against the law.||
5239|304|N|   This medication has been prescribed for your current condition||
5239|305|N|only. Do not use it later for another condition unless told to do||
5239|306|N|so by your doctor. A different medication may be necessary in||
5239|307|N|that case.||
5239|308|B|||
5239|309|D|MISSED DOSE:  Not applicable.||
5239|310|B|||
5239|311|R|STORAGE:  Store at room temperature away from light and moisture.||
5239|312|R|Keep all medications away from children and pets.||
5239|313|R|   Do not flush medications down the toilet or pour them into a||
5239|314|R|drain unless instructed to do so. Properly discard this product||
5239|315|R|when it is expired or no longer needed. Consult your pharmacist||
5239|316|R|or local waste disposal company.||
5239|317|B|||
5239|318|A|Information last revised August 2025.||
5239|319|A|Copyright(c) 2025 First Databank, Inc.||
5239|320|B|||
5241|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5241|002|Z|does NOT have all possible information about this product. This||
5241|003|Z|information does not assure that this product is safe, effective,||
5241|004|Z|or appropriate for you. This information is not individual||
5241|005|Z|medical advice and does not substitute for the advice of your||
5241|006|Z|health care professional. Always ask your health care||
5241|007|Z|professional for complete information about this product and your||
5241|008|Z|specific health needs.||
5241|009|B|||
5241|010|T|NAPROXEN ENTERIC-COATED TABLET - ORAL||
5241|011|F|(nah-PROX-en)||
5241|012|B|||
5241|013|C|COMMON BRAND NAME(S): EC-Naprosyn||
5241|014|B|||
5241|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
5241|016|W|naproxen) may rarely increase the risk for a heart attack or||
5241|017|W|stroke. This effect can happen at any time while taking this drug||
5241|018|W|but is more likely if you take it for a long time. The risk may||
5241|019|W|be greater in older adults or if you have heart disease or||
5241|020|W|increased risk for heart disease (for example, due to smoking,||
5241|021|W|family history of heart disease, or conditions such as high blood||
5241|022|W|pressure or diabetes). Do not take this drug right before or||
5241|023|W|after heart bypass surgery (CABG).||
5241|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
5241|025|W|from the stomach or intestines. This effect can occur without||
5241|026|W|warning at any time while taking this drug. Older adults may be||
5241|027|W|at higher risk for this effect.||
5241|028|W|   Stop taking naproxen and get medical help right away if you||
5241|029|W|notice any of these rare but serious side effects:||
5241|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
5241|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
5241|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
5241|033|W|side of the body, trouble speaking, sudden vision changes.||
5241|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
5241|035|W|of taking this drug.||
5241|036|B|||
5241|037|U|USES:  Naproxen is used to relieve mild to moderate pain from||
5241|038|U|various conditions. It also reduces pain, swelling, and joint||
5241|039|U|stiffness from arthritis. This medication is known as a||
5241|040|U|nonsteroidal anti-inflammatory drug (NSAID). It works by blocking||
5241|041|U|your body's production of certain natural substances that cause||
5241|042|U|inflammation.||
5241|043|U|   If you are treating a chronic condition such as arthritis, ask||
5241|044|U|your doctor about non-drug treatments and/or using other||
5241|045|U|medications to treat your pain. See also Warning section.||
5241|046|U|   This form of naproxen is absorbed slowly and should not be||
5241|047|U|used for pain that needs quick relief (such as during a gout||
5241|048|U|attack). Ask your doctor or pharmacist about using a different||
5241|049|U|form of this drug or other medications for quick relief of pain.||
5241|050|B|||
5241|051|H|HOW TO USE:  Read the Medication Guide provided by your||
5241|052|H|pharmacist before you start using naproxen and each time you get||
5241|053|H|a refill. If you have any questions, ask your doctor or||
5241|054|H|pharmacist.||
5241|055|H|   Take this medication by mouth as directed by your doctor,||
5241|056|H|usually twice daily with or without food. Swallow this medication||
5241|057|H|whole. Do not break, crush, or chew the tablets. Doing so can||
5241|058|H|release the drug too quickly, increasing the risk of side||
5241|059|H|effects. Take this medication with a full glass of water (8||
5241|060|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
5241|061|H|Do not lie down for at least 10 minutes after taking this drug.||
5241|062|H|   The dosage is based on your medical condition and response to||
5241|063|H|treatment. To reduce your risk of stomach bleeding and other side||
5241|064|H|effects, take this medication at the lowest effective dose for||
5241|065|H|the shortest possible time. Do not increase your dose or take||
5241|066|H|this drug more often than directed. For ongoing conditions such||
5241|067|H|as arthritis, keep taking this medication as directed by your||
5241|068|H|doctor.||
5241|069|H|   For certain conditions (such as arthritis), it may take up to||
5241|070|H|two weeks of taking this drug regularly until you get the full||
5241|071|H|benefit.||
5241|072|H|   Tell your doctor if your condition does not get better or if||
5241|073|H|it gets worse.||
5241|074|B|||
5241|075|S|SIDE EFFECTS:  See also Warning section.||
5241|076|S|   Upset stomach, nausea, heartburn, headache, drowsiness, or||
5241|077|S|dizziness may occur. If any of these effects last or get worse,||
5241|078|S|tell your doctor or pharmacist promptly.||
5241|079|S|   Remember that this medication has been prescribed because your||
5241|080|S|doctor has judged that the benefit to you is greater than the||
5241|081|S|risk of side effects. Many people using this medication do not||
5241|082|S|have serious side effects.||
5241|083|S|   This medication may raise your blood pressure. Check your||
5241|084|S|blood pressure regularly and tell your doctor if the results are||
5241|085|S|high.||
5241|086|S|   Tell your doctor right away if you have any serious side||
5241|087|S|effects, including: easy bruising/bleeding, difficult/painful||
5241|088|S|swallowing, hearing changes (such as ringing in the ears),||
5241|089|S|mental/mood changes, signs of kidney problems (such as change in||
5241|090|S|the amount of urine), vision changes, symptoms of heart failure||
5241|091|S|(such as swelling ankles/feet, unusual tiredness, unusual/sudden||
5241|092|S|weight gain).||
5241|093|S|   This drug may rarely cause serious (possibly fatal) liver||
5241|094|S|disease. Get medical help right away if you have any symptoms of||
5241|095|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
5241|096|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
5241|097|S|eyes/skin.||
5241|098|S|   A very serious allergic reaction to this drug is rare.||
5241|099|S|However, get medical help right away if you notice any symptoms||
5241|100|S|of a serious allergic reaction, including: fever, swollen lymph||
5241|101|S|nodes, rash, itching/swelling (especially of the||
5241|102|S|face/tongue/throat), severe dizziness, trouble breathing.||
5241|103|S|   This is not a complete list of possible side effects. If you||
5241|104|S|notice other effects not listed above, contact your doctor or||
5241|105|S|pharmacist.||
5241|106|S|   In the US -||
5241|107|S|   Call your doctor for medical advice about side effects. You||
5241|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5241|109|S|www.fda.gov/medwatch.||
5241|110|S|   In Canada - Call your doctor for medical advice about side||
5241|111|S|effects. You may report side effects to Health Canada at||
5241|112|S|1-866-234-2345.||
5241|113|B|||
5241|114|P|PRECAUTIONS:  Before taking naproxen, tell your doctor or||
5241|115|P|pharmacist if you are allergic to it; or to aspirin or other||
5241|116|P|NSAIDs (such as ibuprofen, celecoxib); or if you have any other||
5241|117|P|allergies. This product may contain inactive ingredients, which||
5241|118|P|can cause allergic reactions or other problems. Talk to your||
5241|119|P|pharmacist for more details.||
5241|120|P|   Before taking this medication, tell your doctor or pharmacist||
5241|121|P|your medical history, especially of: asthma (including a history||
5241|122|P|of worsening breathing after taking aspirin or other NSAIDs),||
5241|123|P|blood disorders (such as anemia, bleeding/clotting problems),||
5241|124|P|growths in the nose (nasal polyps), heart disease (such as||
5241|125|P|previous heart attack), high blood pressure, liver disease,||
5241|126|P|stroke, throat/stomach/intestinal problems (such as bleeding,||
5241|127|P|heartburn, ulcers).||
5241|128|P|   Kidney problems can sometimes occur with the use of NSAID||
5241|129|P|medications, including naproxen. Problems are more likely to||
5241|130|P|occur if you are dehydrated, have heart failure or kidney||
5241|131|P|disease, are an older adult, or if you take certain medications||
5241|132|P|(see also Drug Interactions section). Drink plenty of fluids as||
5241|133|P|directed by your doctor to prevent dehydration and tell your||
5241|134|P|doctor right away if you have a change in the amount of urine.||
5241|135|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5241|136|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5241|137|P|machinery, or do anything that needs alertness until you can do||
5241|138|P|it safely. Talk to your doctor if you are using marijuana||
5241|139|P|(cannabis).||
5241|140|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
5241|141|P|and tobacco, especially when combined with this medicine, may||
5241|142|P|increase your risk for stomach bleeding. Limit alcohol and stop||
5241|143|P|smoking. Consult your doctor or pharmacist for more information.||
5241|144|P|   This medication may make you more sensitive to the sun. Limit||
5241|145|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5241|146|P|sunscreen and wear protective clothing when outdoors. Tell your||
5241|147|P|doctor right away if you get sunburned or have skin||
5241|148|P|blisters/redness.||
5241|149|P|   Before having surgery, tell your doctor or dentist about all||
5241|150|P|the products you use (including prescription drugs,||
5241|151|P|nonprescription drugs, and herbal products).||
5241|152|P|   Older adults may be at greater risk for stomach/intestinal||
5241|153|P|bleeding, kidney problems, heart attack, and stroke while using||
5241|154|P|this drug.||
5241|155|P|   Before using this medication, women of childbearing age should||
5241|156|P|talk with their doctor(s) about the benefits and risks. Tell your||
5241|157|P|doctor if you are pregnant or if you plan to become pregnant.||
5241|158|P|This medication may harm an unborn baby and cause problems with||
5241|159|P|normal labor/delivery. It is not recommended for use in pregnancy||
5241|160|P|from 20 weeks until delivery. If your doctor decides that you||
5241|161|P|need to use this medication between 20 and 30 weeks of pregnancy,||
5241|162|P|you should use the lowest effective dose for the shortest||
5241|163|P|possible time. You should not use this medication after 30 weeks||
5241|164|P|of pregnancy.||
5241|165|P|   This drug passes into breast milk and may have undesirable||
5241|166|P|effects on a nursing infant. Consult your doctor before||
5241|167|P|breastfeeding.||
5241|168|B|||
5241|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5241|170|I|medications work or increase your risk for serious side effects.||
5241|171|I|This document does not contain all possible drug interactions.||
5241|172|I|Keep a list of all the products you use (including||
5241|173|I|prescription/nonprescription drugs and herbal products) and share||
5241|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
5241|175|I|the dosage of any medicines without your doctor's approval.||
5241|176|I|   Products that may interact with this drug include: aliskiren,||
5241|177|I|ACE inhibitors (such as captopril, lisinopril), angiotensin II||
5241|178|I|receptor blockers (such as valsartan, losartan), cidofovir,||
5241|179|I|corticosteroids (such as prednisone), lithium, "water pills"||
5241|180|I|(diuretics such as furosemide).||
5241|181|I|   Do not take this medication with antacids or other drugs that||
5241|182|I|decrease stomach acid (including famotidine, ranitidine, proton||
5241|183|I|pump inhibitors such as omeprazole). These products may affect||
5241|184|I|the enteric coating of this drug, causing the medication to be||
5241|185|I|released too quickly and increasing the risk of side effects.||
5241|186|I|   This medication may increase the risk of bleeding when taken||
5241|187|I|with other drugs that also may cause bleeding. Examples include||
5241|188|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
5241|189|I|dabigatran/enoxaparin/warfarin, among others.||
5241|190|I|   Check all prescription and nonprescription medicine labels||
5241|191|I|carefully since many medications contain pain relievers/fever||
5241|192|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or||
5241|193|I|ketorolac). These drugs are similar to naproxen and may increase||
5241|194|I|your risk of side effects if taken together. However, if your||
5241|195|I|doctor has told you to take low-dose aspirin to prevent heart||
5241|196|I|attack or stroke (usually 81-162 milligrams a day), you should||
5241|197|I|keep taking the aspirin unless your doctor tells you not to.||
5241|198|I|Daily use of naproxen may decrease aspirin's ability to prevent||
5241|199|I|heart attack/stroke. Talk with your doctor about the risks and||
5241|200|I|benefits. Ask about other medications that can be used to treat||
5241|201|I|pain/fever.||
5241|202|I|   This medication may interfere with certain lab tests, possibly||
5241|203|I|causing false test results. Make sure lab personnel and all your||
5241|204|I|doctors know you use this drug..||
5241|205|B|||
5241|206|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5241|207|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5241|208|O|poison control center right away. US residents can call||
5241|209|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5241|210|O|Symptoms of overdose may include: severe stomach pain, extreme||
5241|211|O|drowsiness, seizures.||
5241|212|B|||
5241|213|N|NOTES:  Do not share this medication with others.||
5241|214|N|   Lab and/or medical tests (such as blood pressure, complete||
5241|215|N|blood count, liver/kidney function) may be done while you are||
5241|216|N|taking this medication. Keep all medical and lab appointments.||
5241|217|N|Consult your doctor for more details.||
5241|218|N|   If you have arthritis, lifestyle changes (such as weight loss||
5241|219|N|if needed, strengthening/conditioning exercises) may help improve||
5241|220|N|your flexibility and joint function. Consult your doctor for||
5241|221|N|specific instructions.||
5241|222|B|||
5241|223|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5241|224|D|remember. If it is near the time of the next dose, skip the||
5241|225|D|missed dose. Take your next dose at the regular time. Do not||
5241|226|D|double the dose to catch up.||
5241|227|B|||
5241|228|R|STORAGE:  Store at room temperature away from light and moisture.||
5241|229|R|Do not store in the bathroom. Keep all medications away from||
5241|230|R|children and pets.||
5241|231|R|   Do not flush medications down the toilet or pour them into a||
5241|232|R|drain unless instructed to do so. Properly discard this product||
5241|233|R|when it is expired or no longer needed. Consult your pharmacist||
5241|234|R|or local waste disposal company.||
5241|235|B|||
5241|236|A|Information last revised October 2024.||
5241|237|A|Copyright(c) 2025 First Databank, Inc.||
5241|238|B|||
5244|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5244|002|Z|does NOT have all possible information about this product. This||
5244|003|Z|information does not assure that this product is safe, effective,||
5244|004|Z|or appropriate for you. This information is not individual||
5244|005|Z|medical advice and does not substitute for the advice of your||
5244|006|Z|health care professional. Always ask your health care||
5244|007|Z|professional for complete information about this product and your||
5244|008|Z|specific health needs.||
5244|009|B|||
5244|010|T|LORAZEPAM - ORAL||
5244|011|F|(lor-AYE-zeh-pam)||
5244|012|B|||
5244|013|C|COMMON BRAND NAME(S): Ativan||
5244|014|B|||
5244|015|W|WARNING:  Lorazepam has a risk for abuse and addiction, which can||
5244|016|W|lead to overdose and death. Taking this medication with alcohol||
5244|017|W|or other drugs that can cause drowsiness or breathing problems||
5244|018|W|(especially opioid medications such as codeine, hydrocodone) may||
5244|019|W|cause very serious side effects, including death. To lower your||
5244|020|W|risk, your doctor should have you take the smallest dose of||
5244|021|W|lorazepam that works, and take it for the shortest possible time.||
5244|022|W|Be sure you know how to take lorazepam and what other drugs you||
5244|023|W|should avoid taking with it. See also Drug Interactions section.||
5244|024|W|Get medical help right away if any of these very serious side||
5244|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
5244|026|W|severe drowsiness/dizziness, difficulty waking up.||
5244|027|W|   Suddenly stopping this medication may cause serious (possibly||
5244|028|W|fatal) withdrawal, especially if you have used it for a long time||
5244|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
5244|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
5244|031|W|you have any withdrawal symptoms such as headaches, trouble||
5244|032|W|sleeping, restlessness, hallucinations/confusion, depression,||
5244|033|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
5244|034|W|to months.||
5244|035|B|||
5244|036|U|USES:  This medication is used to treat anxiety. Lorazepam||
5244|037|U|belongs to a class of drugs known as benzodiazepines which act on||
5244|038|U|the brain and nerves (central nervous system) to produce a||
5244|039|U|calming effect. This drug works by enhancing the effects of a||
5244|040|U|certain natural chemical in the body (GABA).||
5244|041|B|||
5244|042|V|OTHER USES:  This section contains uses of this drug that are not||
5244|043|V|listed in the approved professional labeling for the drug but||
5244|044|V|that may be prescribed by your health care professional. Use this||
5244|045|V|drug for a condition that is listed in this section only if it||
5244|046|V|has been so prescribed by your health care professional.||
5244|047|V|   If directed by your doctor, this drug may also be used for||
5244|048|V|sleeping trouble (insomnia) or to reduce the symptoms of alcohol||
5244|049|V|withdrawal. It may also be used to reduce the risk of nausea and||
5244|050|V|vomiting due to chemotherapy.||
5244|051|B|||
5244|052|H|HOW TO USE:  See also Warning section.||
5244|053|H|   Read the Medication Guide provided by your pharmacist before||
5244|054|H|you start taking lorazepam and each time you get a refill. If you||
5244|055|H|have any questions, ask your doctor or pharmacist.||
5244|056|H|   Take this medication by mouth with or without food as directed||
5244|057|H|by your doctor. The dosage is based on your medical condition,||
5244|058|H|age, and response to treatment.||
5244|059|H|   If directed by your doctor, use this medication regularly in||
5244|060|H|order to get the most benefit from it. To help you remember, use||
5244|061|H|it at the same time(s) each day.||
5244|062|H|   Do not suddenly stop using this drug without consulting your||
5244|063|H|doctor. Some conditions may become worse when this drug is||
5244|064|H|abruptly stopped. Your dose may need to be gradually decreased.||
5244|065|H|   When this medication is used for a long time, it may not work||
5244|066|H|as well. Talk with your doctor if this medication stops working||
5244|067|H|well.||
5244|068|H|   Though it helps many people, this medication may sometimes||
5244|069|H|cause addiction. This risk may be higher if you have a substance||
5244|070|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
5244|071|H|Take this medication exactly as prescribed to lower the risk of||
5244|072|H|addiction. Ask your doctor or pharmacist for more details.||
5244|073|H|   Tell your doctor if your condition lasts or gets worse.||
5244|074|B|||
5244|075|S|SIDE EFFECTS:  See also Warning section.||
5244|076|S|   Drowsiness, dizziness, loss of coordination, headache, nausea,||
5244|077|S|blurred vision, change in sexual interest/ability, constipation,||
5244|078|S|heartburn, or change in appetite may occur. If any of these||
5244|079|S|effects last or get worse, tell your doctor or pharmacist||
5244|080|S|promptly.||
5244|081|S|   Remember that this medication has been prescribed because your||
5244|082|S|doctor has judged that the benefit to you is greater than the||
5244|083|S|risk of side effects. Many people using this medication do not||
5244|084|S|have serious side effects.||
5244|085|S|   Tell your doctor right away if you have any serious side||
5244|086|S|effects, including: mental/mood changes (such as hallucinations,||
5244|087|S|depression, thoughts of suicide), trouble speaking, vision||
5244|088|S|changes, unusual weakness, trouble walking, memory problems,||
5244|089|S|signs of infection (such as sore throat that doesn't go away,||
5244|090|S|fever, chills).||
5244|091|S|   Get medical help right away if you have any very serious side||
5244|092|S|effects, including: seizures, slow/shallow breathing.||
5244|093|S|   This medication can rarely have the opposite of its usual||
5244|094|S|calming effect. Symptoms of this opposite effect may include||
5244|095|S|agitation, irritability, violent behavior, confusion,||
5244|096|S|restlessness, excitement, and talking more than normal. Tell your||
5244|097|S|doctor right away if you notice any of these effects.||
5244|098|S|   A very serious allergic reaction to this drug is rare.||
5244|099|S|However, get medical help right away if you notice any symptoms||
5244|100|S|of a serious allergic reaction, including: rash, itching/swelling||
5244|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5244|102|S|breathing.||
5244|103|S|   This is not a complete list of possible side effects. If you||
5244|104|S|notice other effects not listed above, contact your doctor or||
5244|105|S|pharmacist.||
5244|106|S|   In the US -||
5244|107|S|   Call your doctor for medical advice about side effects. You||
5244|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5244|109|S|www.fda.gov/medwatch.||
5244|110|S|   In Canada - Call your doctor for medical advice about side||
5244|111|S|effects. You may report side effects to Health Canada at||
5244|112|S|1-866-234-2345.||
5244|113|B|||
5244|114|P|PRECAUTIONS:  Before taking lorazepam, tell your doctor or||
5244|115|P|pharmacist if you are allergic to it; or to other benzodiazepines||
5244|116|P|(such as alprazolam, clonazepam, diazepam); or if you have any||
5244|117|P|other allergies. This product may contain inactive ingredients,||
5244|118|P|which can cause allergic reactions or other problems. Talk to||
5244|119|P|your pharmacist for more details.||
5244|120|P|   Before using this medication, tell your doctor or pharmacist||
5244|121|P|your medical history, especially of: kidney disease, liver||
5244|122|P|disease, glaucoma, lung/breathing problems (such as sleep apnea),||
5244|123|P|mental/mood disorders (such as depression, psychosis), personal||
5244|124|P|or family history of a substance use disorder (such as overuse of||
5244|125|P|or addiction to drugs/alcohol).||
5244|126|P|   This drug may make you dizzy or drowsy or blur your vision.||
5244|127|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
5244|128|P|drowsy. Do not drive, use machinery, or do anything that needs||
5244|129|P|alertness or clear vision until you can do it safely. Avoid||
5244|130|P|alcoholic beverages. Talk to your doctor if you are using||
5244|131|P|marijuana (cannabis).||
5244|132|P|   Before having surgery, tell your doctor or dentist about all||
5244|133|P|the products you use (including prescription drugs,||
5244|134|P|nonprescription drugs, and herbal products).||
5244|135|P|   Older adults may be more sensitive to the side effects of this||
5244|136|P|drug, especially loss of coordination and drowsiness. Loss of||
5244|137|P|coordination and drowsiness may increase the risk of falling.||
5244|138|P|Also, lorazepam may have the opposite of its usual calming effect||
5244|139|P|in older adults (see also Side Effects section).||
5244|140|P|   This drug may have the opposite of its usual calming effect in||
5244|141|P|children, causing restlessness, shaking, or mental/mood changes||
5244|142|P|(such as agitation, hallucinations).||
5244|143|P|   Tell your doctor if you are pregnant or plan to become||
5244|144|P|pregnant. You should not become pregnant while using lorazepam.||
5244|145|P|Lorazepam may harm an unborn baby. Newborn babies of mothers who||
5244|146|P|use this medication late in pregnancy may have symptoms such as||
5244|147|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
5244|148|P|feeding. If you become pregnant, talk to your doctor right away||
5244|149|P|about the risks and benefits of this medication.||
5244|150|P|   This drug passes into breast milk. Consult your doctor before||
5244|151|P|breastfeeding.||
5244|152|B|||
5244|153|I|DRUG INTERACTIONS:  See also Warning section.||
5244|154|I|   Drug interactions may change how your medications work or||
5244|155|I|increase your risk for serious side effects. This document does||
5244|156|I|not contain all possible drug interactions. Keep a list of all||
5244|157|I|the products you use (including prescription/nonprescription||
5244|158|I|drugs and herbal products) and share it with your doctor and||
5244|159|I|pharmacist. Do not start, stop, or change the dosage of any||
5244|160|I|medicines without your doctor's approval.||
5244|161|I|   Some products that may interact with this drug include:||
5244|162|I|clozapine, kava, sodium oxybate (also known as gamma||
5244|163|I|hydroxybutyrate or GHB).||
5244|164|I|   The risk of serious side effects (such as slow/shallow||
5244|165|I|breathing, severe drowsiness/dizziness) may be increased if this||
5244|166|I|medication is taken with other products that may also cause||
5244|167|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5244|168|I|if you are taking other products such as opioid pain or cough||
5244|169|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5244|170|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
5244|171|I|diazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5244|172|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5244|173|I|diphenhydramine).||
5244|174|I|   Check the labels on all your medicines (such as allergy or||
5244|175|I|cough-and-cold products) because they may contain ingredients||
5244|176|I|that cause drowsiness. Ask your pharmacist about using those||
5244|177|I|products safely.||
5244|178|B|||
5244|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5244|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5244|181|O|poison control center right away. US residents can call||
5244|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5244|183|O|Symptoms of overdose may include confusion, slow reflexes,||
5244|184|O|clumsiness, deep sleep, and loss of consciousness.||
5244|185|B|||
5244|186|N|NOTES:  Lifestyle changes such as starting a stress reduction||
5244|187|N|program may increase the effectiveness of this medication. Talk||
5244|188|N|to your doctor or pharmacist about lifestyle changes that might||
5244|189|N|benefit you.||
5244|190|N|   Do not share this medication with others. Sharing it is||
5244|191|N|against the law.||
5244|192|N|   Lab and/or medical tests (such as blood counts, liver||
5244|193|N|function) should be done while you are taking this medication.||
5244|194|N|Keep all medical and lab appointments. Consult your doctor for||
5244|195|N|more details.||
5244|196|B|||
5244|197|D|MISSED DOSE:  If you miss a dose and are taking more than 1 dose||
5244|198|D|daily, do not take it if it is almost time for the next dose.||
5244|199|D|Instead, skip the missed dose. Take your next dose at the regular||
5244|200|D|time. Do not double the dose to catch up. If you take it once||
5244|201|D|daily at bedtime and miss a dose, do not take it the following||
5244|202|D|morning. Call your doctor to find out what to do.||
5244|203|B|||
5244|204|R|STORAGE:  Store at room temperature away from light and moisture.||
5244|205|R|Do not store in the bathroom. Keep all medications away from||
5244|206|R|children and pets.||
5244|207|R|   Do not flush medications down the toilet or pour them into a||
5244|208|R|drain unless instructed to do so. Properly discard this product||
5244|209|R|when it is expired or no longer needed. Consult your pharmacist||
5244|210|R|or local waste disposal company.||
5244|211|B|||
5244|212|M|MEDICAL ALERT:  Your condition can cause complications in a||
5244|213|M|medical emergency. For information about enrolling in MedicAlert,||
5244|214|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5244|215|B|||
5244|216|A|Information last revised May 2025.||
5244|217|A|Copyright(c) 2025 First Databank, Inc.||
5244|218|B|||
5245|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5245|002|Z|does NOT have all possible information about this product. This||
5245|003|Z|information does not assure that this product is safe, effective,||
5245|004|Z|or appropriate for you. This information is not individual||
5245|005|Z|medical advice and does not substitute for the advice of your||
5245|006|Z|health care professional. Always ask your health care||
5245|007|Z|professional for complete information about this product and your||
5245|008|Z|specific health needs.||
5245|009|B|||
5245|010|T|BUDESONIDE BREATH-ACTIVATED INHALER - ORAL INHALATION||
5245|011|F|(bue-DES-oh-nide)||
5245|012|B|||
5245|013|C|COMMON BRAND NAME(S): Pulmicort||
5245|014|B|||
5245|015|U|USES:  Budesonide is used to control and prevent symptoms||
5245|016|U|(wheezing and shortness of breath) caused by asthma. This||
5245|017|U|medication belongs to a class of drugs known as corticosteroids.||
5245|018|U|It works directly in the lungs to make breathing easier by||
5245|019|U|reducing the irritation and swelling of the airways.||
5245|020|U|   This medication must be used regularly to be effective. It||
5245|021|U|does not work right away and should not be used to relieve sudden||
5245|022|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
5245|023|U|inhaler as prescribed.||
5245|024|B|||
5245|025|V|OTHER USES:  This section contains uses of this drug that are not||
5245|026|V|listed in the approved professional labeling for the drug but||
5245|027|V|that may be prescribed by your health care professional. Use this||
5245|028|V|drug for a condition that is listed in this section only if it||
5245|029|V|has been so prescribed by your health care professional.||
5245|030|V|   This drug may also be used for lung diseases such as||
5245|031|V|bronchitis and emphysema.||
5245|032|B|||
5245|033|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
5245|034|H|your pharmacist before you start using this medication and each||
5245|035|H|time you get a refill. Follow the illustrated directions for the||
5245|036|H|proper use of this medication. If you have any questions, ask||
5245|037|H|your doctor or pharmacist.||
5245|038|H|   Do not shake this product, and do not use a spacer with it.||
5245|039|H|Hold the device upright while using. If the inhaler device is||
5245|040|H|dropped or shaken, or if you accidentally breathe into the device||
5245|041|H|after the dose has been loaded, you will lose the dose. Load||
5245|042|H|another dose. Do not use the inhaler if it has been damaged or if||
5245|043|H|the mouthpiece has come off.||
5245|044|H|   Inhale this medication by mouth as directed by your doctor,||
5245|045|H|usually once or twice daily. Inhale deeply and forcefully while||
5245|046|H|using the device. Turn your mouth away from the device to breathe||
5245|047|H|out before inhaling. Do not exhale back into the device.||
5245|048|H|   If your prescribed dose is 2 puffs, wait at least one minute||
5245|049|H|between them. If you are using other inhalers at the same time,||
5245|050|H|wait at least 1 minute between the use of each medication, and||
5245|051|H|use this drug (the corticosteroid) last.||
5245|052|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
5245|053|H|from developing, gargle, rinse your mouth with water and spit out||
5245|054|H|after each use. Do not swallow the rinse water.||
5245|055|H|   Keep track of each dose of medication you use. Discard the||
5245|056|H|device after it has delivered the labeled number of doses or when||
5245|057|H|the red mark reaches the bottom of the dose indicator window.||
5245|058|H|   The dosage is based on your medical condition and response to||
5245|059|H|treatment. Use this medication regularly to get the most benefit||
5245|060|H|from it. To help you remember, use it at the same time(s) each||
5245|061|H|day. Do not increase your dose or use this drug more often or for||
5245|062|H|longer than prescribed. Your condition will not improve any||
5245|063|H|faster, and your risk of side effects will increase.||
5245|064|H|   Learn which of your inhalers you should use every day||
5245|065|H|(controller drugs) and which you should use if your breathing||
5245|066|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
5245|067|H|time what you should do if you have new or worsening cough or||
5245|068|H|shortness of breath, wheezing, increased sputum, worsening peak||
5245|069|H|flow meter readings, waking up at night with trouble breathing,||
5245|070|H|if you use your quick-relief inhaler more often (more than 2 days||
5245|071|H|a week), or if your quick-relief inhaler does not seem to be||
5245|072|H|working well. Learn when you can treat sudden breathing problems||
5245|073|H|by yourself and when you must get medical help right away.||
5245|074|H|   If you are regularly taking a different corticosteroid by||
5245|075|H|mouth (such as prednisone), you should not stop taking it unless||
5245|076|H|directed by your doctor. Some conditions (such as asthma,||
5245|077|H|allergies) may become worse when the drug is suddenly stopped. If||
5245|078|H|you suddenly stop taking the drug, you may also have withdrawal||
5245|079|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
5245|080|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
5245|081|H|doctor may slowly lower the dose of your old medication after you||
5245|082|H|begin using budesonide. Tell your doctor or pharmacist right away||
5245|083|H|if you have withdrawal. See also Precautions section.||
5245|084|H|   You may notice a benefit within 24 hours of starting this||
5245|085|H|drug. It may take 1 to 2 weeks before the full benefit of this||
5245|086|H|drug takes effect. Tell your doctor if your symptoms do not get||
5245|087|H|better or if they get worse.||
5245|088|B|||
5245|089|S|SIDE EFFECTS:  See also Precautions section.||
5245|090|S|   Dry/irritated throat, hoarseness, voice changes, nausea, bad||
5245|091|S|taste in the mouth, runny/stuffy nose, or nosebleeds may occur.||
5245|092|S|If any of these effects last or get worse, tell your doctor or||
5245|093|S|pharmacist promptly.||
5245|094|S|   Remember that this medication has been prescribed because your||
5245|095|S|doctor has judged that the benefit to you is greater than the||
5245|096|S|risk of side effects. Many people using this medication do not||
5245|097|S|have serious side effects.||
5245|098|S|   Rarely, this medication may cause sudden breathing||
5245|099|S|problems/asthma right after you use it. If this occurs, use your||
5245|100|S|quick-relief inhaler and get medical help right away.||
5245|101|S|   Because this drug works by weakening the immune system, it may||
5245|102|S|lower your ability to fight infections. This may make you more||
5245|103|S|likely to get a serious (rarely fatal) infection or make any||
5245|104|S|infection you have worse. Tell your doctor right away if you have||
5245|105|S|any signs of infection (such sore throat that doesn't go away,||
5245|106|S|fever, chills). Use of this medication for prolonged or repeated||
5245|107|S|periods may result in oral thrush (yeast infection). Contact your||
5245|108|S|doctor if you notice white patches in your mouth or on your||
5245|109|S|tongue.||
5245|110|S|   Tell your doctor right away if you have any serious side||
5245|111|S|effects, including: unusual tiredness, vision problems, easy||
5245|112|S|bruising/bleeding, puffy face, unusual hair growth, mental/mood||
5245|113|S|changes (such as depression, mood swings, agitation), muscle||
5245|114|S|weakness/pain, thinning skin, slow wound healing, increased||
5245|115|S|thirst/urination.||
5245|116|S|   A very serious allergic reaction to this product is rare.||
5245|117|S|However, get medical help right away if you notice any symptoms||
5245|118|S|of a serious allergic reaction, including: rash, itching/swelling||
5245|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5245|120|S|breathing.||
5245|121|S|   This is not a complete list of possible side effects. If you||
5245|122|S|notice other effects not listed above, contact your doctor or||
5245|123|S|pharmacist.||
5245|124|S|   In the US -||
5245|125|S|   Call your doctor for medical advice about side effects. You||
5245|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5245|127|S|www.fda.gov/medwatch.||
5245|128|S|   In Canada - Call your doctor for medical advice about side||
5245|129|S|effects. You may report side effects to Health Canada at||
5245|130|S|1-866-234-2345.||
5245|131|B|||
5245|132|P|PRECAUTIONS:  Before using budesonide, tell your doctor or||
5245|133|P|pharmacist if you are allergic to it; or if you have any other||
5245|134|P|allergies. This product may contain inactive ingredients (such as||
5245|135|P|lactose, milk proteins found in some brands), which can cause||
5245|136|P|allergic reactions or other problems. Talk to your pharmacist for||
5245|137|P|more details.||
5245|138|P|   Before using this medication, tell your doctor or pharmacist||
5245|139|P|your medical history, especially of: eye disease (such as||
5245|140|P|cataracts, glaucoma), high blood pressure, liver disease, thyroid||
5245|141|P|problems, diabetes, stomach/intestinal problems (such as||
5245|142|P|diverticulitis, ulcer), bone loss (osteoporosis), current/past||
5245|143|P|infections (such as tuberculosis, positive tuberculosis test,||
5245|144|P|herpes, fungal), bleeding problems, mental/mood conditions (such||
5245|145|P|as psychosis, anxiety, depression).||
5245|146|P|   If you have switched from a corticosteroid taken by mouth||
5245|147|P|(such as prednisone tablets) to this inhaler within the past 12||
5245|148|P|months, or if you have been using this product in||
5245|149|P|higher-than-usual doses for a long time, it may be more difficult||
5245|150|P|for your body to respond to physical stress. Before having||
5245|151|P|surgery or emergency treatment, or if you get a serious||
5245|152|P|illness/injury, tell your doctor or dentist that you are using||
5245|153|P|this medication or have used a corticosteroid taken by mouth||
5245|154|P|within the past 12 months. Tell your doctor right away if you||
5245|155|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
5245|156|P|card or medical ID bracelet that says you use (or have used)||
5245|157|P|corticosteroid medications.||
5245|158|P|   Before having surgery, tell your doctor or dentist about all||
5245|159|P|the products you use (including prescription drugs,||
5245|160|P|nonprescription drugs, and herbal products).||
5245|161|P|   This medication may mask signs of infection. It can make you||
5245|162|P|more likely to get infections or may make current infections||
5245|163|P|worse. Stay away from anyone who has an infection that may easily||
5245|164|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
5245|165|P|doctor if you have been exposed to an infection or for more||
5245|166|P|details.||
5245|167|P|   Tell your health care professional that you are using||
5245|168|P|budesonide before having any immunizations/vaccinations. Avoid||
5245|169|P|contact with people who have recently received live vaccines||
5245|170|P|(such as flu vaccine inhaled through the nose).||
5245|171|P|   This medication may temporarily slow down a child's growth if||
5245|172|P|used for a long time. However, poorly controlled asthma can also||
5245|173|P|slow down growth. See the doctor regularly so your child's height||
5245|174|P|can be checked.||
5245|175|P|   During pregnancy, this medication should be used only when||
5245|176|P|clearly needed. Discuss the risks and benefits with your doctor.||
5245|177|P|   This medication passes into breast milk. Consult your doctor||
5245|178|P|before breastfeeding.||
5245|179|B|||
5245|180|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5245|181|I|medications work or increase your risk for serious side effects.||
5245|182|I|This document does not contain all possible drug interactions.||
5245|183|I|Keep a list of all the products you use (including||
5245|184|I|prescription/nonprescription drugs and herbal products) and share||
5245|185|I|it with your doctor and pharmacist. Do not start, stop, or change||
5245|186|I|the dosage of any medicines without your doctor's approval.||
5245|187|I|   Some products that may interact with this drug include:||
5245|188|I|aldesleukin, desmopressin, mifepristone.||
5245|189|I|   This medication may interfere with certain lab tests (such as||
5245|190|I|skin tests), possibly causing false test results. Make sure lab||
5245|191|I|personnel and all your doctors know you use this drug.||
5245|192|B|||
5245|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5245|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5245|195|O|poison control center right away. US residents can call||
5245|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5245|197|B|||
5245|198|N|NOTES:  Do not share this medication with others.||
5245|199|N|   Lab and/or medical tests (such as cortisol levels, bone||
5245|200|N|density tests, eye exams, height/weight measurements) should be||
5245|201|N|done while you are using this medication. Keep all medical and||
5245|202|N|lab appointments. Consult your doctor for more details.||
5245|203|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
5245|204|N|mold that can worsen breathing problems. Because the flu virus||
5245|205|N|can also worsen breathing problems, ask your doctor or pharmacist||
5245|206|N|if you should have a flu shot every year.||
5245|207|N|   This medication may cause bone loss (osteoporosis) in adults||
5245|208|N|when used for a long time. Lifestyle changes that may help reduce||
5245|209|N|the risk of bone problems include doing weight-bearing exercise,||
5245|210|N|stopping smoking, limiting alcohol, and getting enough calcium||
5245|211|N|and vitamin D. Talk to your doctor for more details.||
5245|212|B|||
5245|213|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5245|214|D|If it is near the time of the next dose, skip the missed dose.||
5245|215|D|Use your next dose at the regular time. Do not double the dose to||
5245|216|D|catch up.||
5245|217|B|||
5245|218|R|STORAGE:  Store at room temperature away from light and moisture.||
5245|219|R|Do not store in the bathroom. Keep all medications away from||
5245|220|R|children and pets.||
5245|221|R|   Do not flush medications down the toilet or pour them into a||
5245|222|R|drain unless instructed to do so. Properly discard this product||
5245|223|R|when it is expired or no longer needed. Consult your pharmacist||
5245|224|R|or local waste disposal company.||
5245|225|B|||
5245|226|M|MEDICAL ALERT:  Your condition can cause complications in a||
5245|227|M|medical emergency. For information about enrolling in MedicAlert,||
5245|228|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5245|229|B|||
5245|230|A|Information last revised September 2025.||
5245|231|A|Copyright(c) 2025 First Databank, Inc.||
5245|232|B|||
5249|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5249|002|Z|does NOT have all possible information about this product. This||
5249|003|Z|information does not assure that this product is safe, effective,||
5249|004|Z|or appropriate for you. This information is not individual||
5249|005|Z|medical advice and does not substitute for the advice of your||
5249|006|Z|health care professional. Always ask your health care||
5249|007|Z|professional for complete information about this product and your||
5249|008|Z|specific health needs.||
5249|009|B|||
5249|010|T|MULTIVITAMINS (INCLUDES PRENATAL VITAMINS) CHEWABLE - ORAL||
5249|011|B|||
5249|012|W|WARNING:  If your brand of multivitamin contains iron, it is||
5249|013|W|important to keep this product out of reach of children.||
5249|014|W|Accidental overdose of iron-containing products is a leading||
5249|015|W|cause of fatal poisoning in children younger than 6 years. If||
5249|016|W|overdose does occur, get medical help right away or call a poison||
5249|017|W|control center.||
5249|018|B|||
5249|019|U|USES:  This medication is a multivitamin product used to treat or||
5249|020|U|prevent vitamin deficiency due to poor diet, certain illnesses,||
5249|021|U|or during pregnancy. Vitamins are important building blocks of||
5249|022|U|the body and help keep you in good health.||
5249|023|B|||
5249|024|H|HOW TO USE:  Chew this medication thoroughly and swallow, usually||
5249|025|H|once daily or as directed. Follow all directions on the product||
5249|026|H|package, or take as directed by your doctor. Do not take more||
5249|027|H|than the recommended dosage. If you have any questions, ask your||
5249|028|H|doctor or pharmacist.||
5249|029|H|   Take this medication regularly in order to get the most||
5249|030|H|benefit from it. To help you remember, take it at the same time||
5249|031|H|each day.||
5249|032|B|||
5249|033|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
5249|034|S|occur. These effects are usually temporary and may disappear as||
5249|035|S|your body adjusts to this medication. If any of these effects||
5249|036|S|last or get worse, tell your doctor or pharmacist promptly.||
5249|037|S|   If your doctor has prescribed this medication, remember that||
5249|038|S|your doctor has judged that the benefit to you is greater than||
5249|039|S|the risk of side effects. Many people using this medication do||
5249|040|S|not have serious side effects.||
5249|041|S|   A very serious allergic reaction to this drug is rare.||
5249|042|S|However, get medical help right away if you notice any symptoms||
5249|043|S|of a serious allergic reaction, including: rash, itching/swelling||
5249|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5249|045|S|breathing.||
5249|046|S|   This is not a complete list of possible side effects. If you||
5249|047|S|notice other effects not listed above, contact your doctor or||
5249|048|S|pharmacist.||
5249|049|S|   In the US -||
5249|050|S|   Call your doctor for medical advice about side effects. You||
5249|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5249|052|S|www.fda.gov/medwatch.||
5249|053|S|   In Canada - Call your doctor for medical advice about side||
5249|054|S|effects. You may report side effects to Health Canada at||
5249|055|S|1-866-234-2345.||
5249|056|B|||
5249|057|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
5249|058|P|pharmacist if you are allergic to any of its ingredients; or if||
5249|059|P|you have any other allergies. This product may contain inactive||
5249|060|P|ingredients, which can cause allergic reactions or other||
5249|061|P|problems. Talk to your pharmacist for more details.||
5249|062|P|   Before taking this medication, tell your doctor or pharmacist||
5249|063|P|your medical history, especially of: use/abuse of alcohol, liver||
5249|064|P|problems, stomach/intestinal problems (such as ulcer, colitis).||
5249|065|P|   If your brand of multivitamin also contains folic acid, be||
5249|066|P|sure to tell your doctor or pharmacist if you have vitamin B12||
5249|067|P|deficiency (pernicious anemia) before taking it. Folic acid may||
5249|068|P|affect certain lab tests for vitamin B12 deficiency without||
5249|069|P|treating this anemia. Untreated vitamin B12 deficiency may result||
5249|070|P|in serious nerve problems (such as peripheral neuropathy).||
5249|071|P|Consult your doctor or pharmacist for details.||
5249|072|P|   This medicine may contain aspartame. If you have||
5249|073|P|phenylketonuria (PKU) or any other condition that requires you to||
5249|074|P|restrict your intake of aspartame (or phenylalanine), consult||
5249|075|P|your doctor or pharmacist about using this drug safely.||
5249|076|P|   Before having surgery, tell your doctor or dentist about all||
5249|077|P|the products you use (including prescription drugs,||
5249|078|P|nonprescription drugs, and herbal products).||
5249|079|P|   Tell your doctor if you are pregnant before using this||
5249|080|P|medication.||
5249|081|P|   This medication passes into breast milk. Consult your doctor||
5249|082|P|before breastfeeding.||
5249|083|B|||
5249|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5249|085|I|medications work or increase your risk for serious side effects.||
5249|086|I|This document does not contain all possible drug interactions.||
5249|087|I|Keep a list of all the products you use (including||
5249|088|I|prescription/nonprescription drugs and herbal products) and share||
5249|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
5249|090|I|the dosage of any medicines without your doctor's approval.||
5249|091|I|   If your brand of multivitamin also contains calcium, iron,||
5249|092|I|magnesium, or zinc, then it can decrease the absorption of||
5249|093|I|certain drugs, especially if you take them around the same time.||
5249|094|I|These drugs include bisphosphonates (such as alendronate),||
5249|095|I|levodopa, penicillamine, quinolone antibiotics (such as||
5249|096|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
5249|097|I|doxycycline, minocycline), thyroid medications (such as||
5249|098|I|levothyroxine), among others. Ask your doctor or pharmacist how||
5249|099|I|long you should wait between doses of this product and your other||
5249|100|I|medications and to find a dosing schedule that works for all your||
5249|101|I|medications.||
5249|102|I|   This medication may interfere with certain lab tests, possibly||
5249|103|I|causing false test results. Make sure lab personnel and all your||
5249|104|I|doctors know you use this drug.||
5249|105|B|||
5249|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5249|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5249|108|O|poison control center right away. US residents can call||
5249|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5249|110|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
5249|111|O|diarrhea.||
5249|112|B|||
5249|113|N|NOTES:  Keep all medical and lab appointments.||
5249|114|N|   This product is not a substitute for a proper diet. Remember||
5249|115|N|that it is best to get your vitamins from healthy foods. Maintain||
5249|116|N|a well-balanced diet and follow any dietary guidelines as||
5249|117|N|directed by your doctor.||
5249|118|B|||
5249|119|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5249|120|D|remember. If it is near the time of the next dose, skip the||
5249|121|D|missed dose. Take your next dose at the regular time. Do not||
5249|122|D|double the dose to catch up.||
5249|123|B|||
5249|124|R|STORAGE:  Store at room temperature away from light and moisture.||
5249|125|R|Do not store in the bathroom. Keep all medications away from||
5249|126|R|children and pets.||
5249|127|R|   Do not flush medications down the toilet or pour them into a||
5249|128|R|drain unless instructed to do so. Properly discard this product||
5249|129|R|when it is expired or no longer needed. Consult your pharmacist||
5249|130|R|or local waste disposal company.||
5249|131|B|||
5249|132|A|Information last revised October 2025.||
5249|133|A|Copyright(c) 2025 First Databank, Inc.||
5249|134|B|||
5250|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5250|002|Z|does NOT have all possible information about this product. This||
5250|003|Z|information does not assure that this product is safe, effective,||
5250|004|Z|or appropriate for you. This information is not individual||
5250|005|Z|medical advice and does not substitute for the advice of your||
5250|006|Z|health care professional. Always ask your health care||
5250|007|Z|professional for complete information about this product and your||
5250|008|Z|specific health needs.||
5250|009|B|||
5250|010|T|RANITIDINE 75 MG - ORAL||
5250|011|F|(ran-IT-uh-deen)||
5250|012|B|||
5250|013|C|COMMON BRAND NAME(S): Acid Reducer, Zantac 75||
5250|014|B|||
5250|015|U|USES:  Ranitidine is known as an H2 blocker. It works by reducing||
5250|016|U|the amount of acid in your stomach. It is used to prevent and||
5250|017|U|treat heartburn and other symptoms caused by too much acid in the||
5250|018|U|stomach (acid indigestion).||
5250|019|U|   This drug has been withdrawn from the US market due to||
5250|020|U|problems with safety. A possible cancer-causing impurity has been||
5250|021|U|found in some ranitidine products.||
5250|022|B|||
5250|023|H|HOW TO USE:  To treat heartburn and acid indigestion, take 1||
5250|024|H|tablet with a glass of water as needed, unless otherwise directed||
5250|025|H|by your doctor. Swallow the tablet whole without chewing.||
5250|026|H|Ranitidine can be taken with or without food.||
5250|027|H|   To prevent heartburn and acid indigestion, take ranitidine||
5250|028|H|30-60 minutes before eating food or drinking beverages that can||
5250|029|H|cause indigestion.||
5250|030|H|   Do not take more than 2 tablets in 24 hours unless directed by||
5250|031|H|your doctor. Follow all directions on the product package. If you||
5250|032|H|have any questions, ask your doctor or pharmacist.||
5250|033|H|   Tell your doctor if your symptoms last or if they get worse.||
5250|034|H|Do not take this medicine for more than 14 days in a row without||
5250|035|H|talking with your doctor.||
5250|036|B|||
5250|037|S|SIDE EFFECTS:  Headache, constipation or diarrhea may occur. If||
5250|038|S|any of these effects last or get worse, tell your doctor or||
5250|039|S|pharmacist promptly.||
5250|040|S|   Tell your doctor right away if you have any serious side||
5250|041|S|effects, including: vomiting, severe stomach pain, dark urine,||
5250|042|S|yellowing eyes/skin.||
5250|043|S|   A very serious allergic reaction to this drug is rare.||
5250|044|S|However, get medical help right away if you notice any symptoms||
5250|045|S|of a serious allergic reaction, including: rash, itching/swelling||
5250|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5250|047|S|breathing.||
5250|048|S|   This is not a complete list of possible side effects. If you||
5250|049|S|notice other effects not listed above, contact your doctor or||
5250|050|S|pharmacist.||
5250|051|S|   In the US -||
5250|052|S|   Call your doctor for medical advice about side effects. You||
5250|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5250|054|S|www.fda.gov/medwatch.||
5250|055|S|   In Canada - Call your doctor for medical advice about side||
5250|056|S|effects. You may report side effects to Health Canada at||
5250|057|S|1-866-234-2345.||
5250|058|B|||
5250|059|P|PRECAUTIONS:  Before taking ranitidine, tell your doctor or||
5250|060|P|pharmacist if you are allergic to it; or to other H2 blockers||
5250|061|P|(such as cimetidine, famotidine); or if you have any other||
5250|062|P|allergies. This product may contain inactive ingredients, which||
5250|063|P|can cause allergic reactions or other problems. Talk to your||
5250|064|P|pharmacist for more details.||
5250|065|P|   Before using this medication, tell your doctor or pharmacist||
5250|066|P|your medical history, especially of: a certain blood disorder||
5250|067|P|(porphyria), kidney problems, liver problems, other stomach||
5250|068|P|problems (such as tumors).||
5250|069|P|   Some symptoms may actually be signs of a more serious||
5250|070|P|condition. Get medical help right away if you have: heartburn||
5250|071|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
5250|072|P|pain (especially with shortness of breath, unusual sweating),||
5250|073|P|unexplained weight loss.||
5250|074|P|   In addition, before you self-treat with this medication, get||
5250|075|P|medical help right away if you have any of these signs of a||
5250|076|P|serious condition: trouble/pain swallowing food, bloody vomit,||
5250|077|P|vomit that looks like coffee grounds, bloody/black stools,||
5250|078|P|heartburn for over 3 months, frequent chest pain, frequent||
5250|079|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
5250|080|P|pain.||
5250|081|P|   Do not use this medication in children younger than 12 unless||
5250|082|P|directed by the doctor.||
5250|083|P|   Older adults may be more sensitive to the side effects of this||
5250|084|P|drug, especially confusion.||
5250|085|P|   During pregnancy, this medication should only be used if||
5250|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
5250|087|P|Tell your doctor if you are pregnant before using this||
5250|088|P|medication.||
5250|089|P|   Ranitidine passes into breast milk. Consult your doctor before||
5250|090|P|breastfeeding.||
5250|091|B|||
5250|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5250|093|I|medications work or increase your risk for serious side effects.||
5250|094|I|This document does not contain all possible drug interactions.||
5250|095|I|Keep a list of all the products you use (including||
5250|096|I|prescription/nonprescription drugs and herbal products) and share||
5250|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
5250|098|I|the dosage of any medicines without your doctor's approval.||
5250|099|I|   Some products need stomach acid so that the body can absorb||
5250|100|I|them properly. Ranitidine decreases stomach acid, so it may||
5250|101|I|change how well these products work. Some affected products||
5250|102|I|include atazanavir, dasatinib, certain azole antifungals (such as||
5250|103|I|itraconazole, ketoconazole), levoketoconazole, pazopanib,||
5250|104|I|sparsentan, among others.||
5250|105|I|   Do not use this medication with other products that contain||
5250|106|I|ranitidine or other H2 blockers (cimetidine, famotidine,||
5250|107|I|nizatidine).||
5250|108|I|   This medication may interfere with certain lab tests (such as||
5250|109|I|urine protein tests), possibly causing false test results. Make||
5250|110|I|sure lab personnel and all your doctors know you use this drug.||
5250|111|B|||
5250|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5250|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5250|114|O|poison control center right away. US residents can call||
5250|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5250|116|B|||
5250|117|N|NOTES:  Lifestyle changes such as stress reduction programs,||
5250|118|N|stopping smoking, limiting alcohol, and diet changes (such as||
5250|119|N|avoiding caffeine and certain spices) may help this medication||
5250|120|N|work better. Talk to your doctor or pharmacist about lifestyle||
5250|121|N|changes that might benefit you.||
5250|122|B|||
5250|123|D|MISSED DOSE:  Not applicable.||
5250|124|B|||
5250|125|R|STORAGE:  Different brands of this medication have different||
5250|126|R|storage needs. Check the product package for instructions on how||
5250|127|R|to store your brand, or ask your pharmacist. Do not store in the||
5250|128|R|bathroom. Keep all medications away from children and pets.||
5250|129|R|   Do not flush medications down the toilet or pour them into a||
5250|130|R|drain unless instructed to do so. Properly discard this product||
5250|131|R|when it is expired or no longer needed. Consult your pharmacist||
5250|132|R|or local waste disposal company.||
5250|133|B|||
5250|134|A|Information last revised November 2024.||
5250|135|A|Copyright(c) 2025 First Databank, Inc.||
5250|136|B|||
5252|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5252|002|Z|does NOT have all possible information about this product. This||
5252|003|Z|information does not assure that this product is safe, effective,||
5252|004|Z|or appropriate for you. This information is not individual||
5252|005|Z|medical advice and does not substitute for the advice of your||
5252|006|Z|health care professional. Always ask your health care||
5252|007|Z|professional for complete information about this product and your||
5252|008|Z|specific health needs.||
5252|009|B|||
5252|010|T|CALAMINE LOTION - TOPICAL||
5252|011|F|(KAL-a-mine)||
5252|012|B|||
5252|013|U|USES:  This medication is used to relieve pain, itching, and||
5252|014|U|discomfort from minor skin irritations such as poison ivy, poison||
5252|015|U|oak, and poison sumac. It also helps to dry the oozing and||
5252|016|U|weeping caused by irritation due to these plants.||
5252|017|B|||
5252|018|H|HOW TO USE:  Use this medication on the skin only. Follow all||
5252|019|H|directions on the product package, or use as directed by your||
5252|020|H|doctor. Shake the bottle well before using. Apply the medication||
5252|021|H|with a cotton pad, and allow the medication to dry on the skin.||
5252|022|H|If you have any questions, ask your doctor or pharmacist.||
5252|023|H|   Avoid getting this medication in the eyes, mouth, nose, and||
5252|024|H|genital/anal areas. If you do get the medication in those areas,||
5252|025|H|flush with plenty of water.||
5252|026|H|   Tell your doctor if your condition gets worse or if it does||
5252|027|H|not get better within 7 days.||
5252|028|B|||
5252|029|S|SIDE EFFECTS:  If your doctor has directed you to use this||
5252|030|S|medication, remember that your doctor has judged that the benefit||
5252|031|S|to you is greater than the risk of side effects. Many people||
5252|032|S|using this medication do not have serious side effects.||
5252|033|S|   Tell your doctor right away if you have any serious side||
5252|034|S|effects, including: skin irritation.||
5252|035|S|   A very serious allergic reaction to this drug is rare.||
5252|036|S|However, get medical help right away if you notice any symptoms||
5252|037|S|of a serious allergic reaction, including: rash, itching/swelling||
5252|038|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5252|039|S|breathing.||
5252|040|S|   This is not a complete list of possible side effects. If you||
5252|041|S|notice other effects not listed above, contact your doctor or||
5252|042|S|pharmacist.||
5252|043|S|   In the US -||
5252|044|S|   Call your doctor for medical advice about side effects. You||
5252|045|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5252|046|S|www.fda.gov/medwatch.||
5252|047|S|   In Canada - Call your doctor for medical advice about side||
5252|048|S|effects. You may report side effects to Health Canada at||
5252|049|S|1-866-234-2345.||
5252|050|B|||
5252|051|P|PRECAUTIONS:  Before using calamine, tell your doctor or||
5252|052|P|pharmacist if you are allergic to it; or if you have any other||
5252|053|P|allergies. This product may contain inactive ingredients, which||
5252|054|P|can cause allergic reactions or other problems. Talk to your||
5252|055|P|pharmacist for more details.||
5252|056|P|   Tell your doctor if you are pregnant before using this||
5252|057|P|medication.||
5252|058|P|   It is unknown if this drug passes into breast milk. Consult||
5252|059|P|your doctor before breastfeeding.||
5252|060|B|||
5252|061|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5252|062|I|medications work or increase your risk for serious side effects.||
5252|063|I|This document does not contain all possible drug interactions.||
5252|064|I|Keep a list of all the products you use (including||
5252|065|I|prescription/nonprescription drugs and herbal products) and share||
5252|066|I|it with your doctor and pharmacist. Do not start, stop, or change||
5252|067|I|the dosage of any medicines without your doctor's approval.||
5252|068|B|||
5252|069|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5252|070|O|has overdosed and has serious symptoms such as passing out or||
5252|071|O|trouble breathing, call 911. Otherwise, call a poison control||
5252|072|O|center right away. US residents can call 1-800-222-1222. Canada||
5252|073|O|residents can call 1-844-764-7669.||
5252|074|B|||
5252|075|N|NOTES:  Keep all medical and lab appointments.||
5252|076|B|||
5252|077|D|MISSED DOSE:  Not applicable.||
5252|078|B|||
5252|079|R|STORAGE:  Refer to storage information printed on the package. If||
5252|080|R|you have any questions about storage, ask your pharmacist. Keep||
5252|081|R|all medications away from children and pets.||
5252|082|R|   Do not flush medications down the toilet or pour them into a||
5252|083|R|drain unless instructed to do so. Properly discard this product||
5252|084|R|when it is expired or no longer needed. Consult your pharmacist||
5252|085|R|or local waste disposal company.||
5252|086|B|||
5252|087|A|Information last revised November 2024.||
5252|088|A|Copyright(c) 2025 First Databank, Inc.||
5252|089|B|||
5253|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5253|002|Z|does NOT have all possible information about this product. This||
5253|003|Z|information does not assure that this product is safe, effective,||
5253|004|Z|or appropriate for you. This information is not individual||
5253|005|Z|medical advice and does not substitute for the advice of your||
5253|006|Z|health care professional. Always ask your health care||
5253|007|Z|professional for complete information about this product and your||
5253|008|Z|specific health needs.||
5253|009|B|||
5253|010|T|CLOBETASOL SCALP SOLUTION - TOPICAL||
5253|011|F|(kloe-BAY-ta-sol)||
5253|012|B|||
5253|013|C|COMMON BRAND NAME(S): Cormax, Temovate||
5253|014|B|||
5253|015|U|USES:  Clobetasol is used to treat certain scalp and skin||
5253|016|U|conditions (such as psoriasis, dermatitis, rash). Clobetasol||
5253|017|U|reduces the swelling, itching and redness that can occur in these||
5253|018|U|types of conditions. This medication is a very strong||
5253|019|U|(super-high-potency) corticosteroid.||
5253|020|B|||
5253|021|V|OTHER USES:  This section contains uses of this drug that are not||
5253|022|V|listed in the approved professional labeling for the drug but||
5253|023|V|that may be prescribed by your health care professional. Use this||
5253|024|V|drug for a condition that is listed in this section only if it||
5253|025|V|has been so prescribed by your health care professional.||
5253|026|V|   This drug may also be used for certain skin conditions (such||
5253|027|V|as eczema, psoriasis) on other parts of the body.||
5253|028|B|||
5253|029|H|HOW TO USE:  Apply this medication to the affected area of the||
5253|030|H|scalp as directed by your doctor, usually twice daily (in the||
5253|031|H|morning and evening).||
5253|032|H|   Use this medication only on the skin. However, do not use it||
5253|033|H|on the face, groin or underarms unless directed to do so by your||
5253|034|H|doctor.||
5253|035|H|   Wash and dry your hands before applying. Apply the prescribed||
5253|036|H|amount of medication to the affected area and gently rub in. Do||
5253|037|H|not bandage, wrap or cover the area.||
5253|038|H|   After applying the medication, wash your hands, unless you are||
5253|039|H|using this medication to treat the hands. If applying this||
5253|040|H|medication near the eyes, avoid getting it in the eyes because||
5253|041|H|this may worsen or cause glaucoma. Also, avoid getting the||
5253|042|H|medication in your nose or mouth. If you get the medication in||
5253|043|H|your eyes, nose, or mouth, rinse with plenty of water.||
5253|044|H|   Use this medication exactly as prescribed. Do not increase||
5253|045|H|your dose, take it more often, or use it for longer than 2 weeks||
5253|046|H|in a row. Do not apply more than 50 milliliters of medication in||
5253|047|H|a given week unless directed by your doctor. Doing so could||
5253|048|H|increase your risk of side effects.||
5253|049|H|   Tell your doctor if your condition lasts or gets worse after 2||
5253|050|H|weeks.||
5253|051|B|||
5253|052|S|SIDE EFFECTS:  Burning, stinging, itching, irritation, dryness,||
5253|053|S|or redness may occur when this medication is first applied to the||
5253|054|S|scalp/skin. This should disappear in a few days as your body||
5253|055|S|adjusts to the medication. If any of these effects last or get||
5253|056|S|worse, tell your doctor or pharmacist promptly.||
5253|057|S|   Remember that this medication has been prescribed because your||
5253|058|S|doctor has judged that the benefit to you is greater than the||
5253|059|S|risk of side effects. Many people using this medication do not||
5253|060|S|have serious side effects.||
5253|061|S|   Tell your doctor right away if you have any serious side||
5253|062|S|effects, including: stretch marks (striae), skin||
5253|063|S|thinning/discoloration, excessive hair growth, acne, small red||
5253|064|S|bumps on the skin (folliculitis).||
5253|065|S|   Skin infections can become worse when using this medication.||
5253|066|S|Tell your doctor if redness, swelling or irritation does not||
5253|067|S|improve.||
5253|068|S|   Rarely, it is possible this medication will be absorbed from||
5253|069|S|the skin into the bloodstream. This can lead to side effects of||
5253|070|S|too much corticosteroid. These side effects are more likely in||
5253|071|S|children, and in people who use this medication for a long time||
5253|072|S|or over large areas of the skin. Tell your doctor right away if||
5253|073|S|any of the following side effects occur: unusual/extreme||
5253|074|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
5253|075|S|thirst/urination, vision problems.||
5253|076|S|   A very serious allergic reaction to this drug is rare.||
5253|077|S|However, get medical help right away if you notice any symptoms||
5253|078|S|of a serious allergic reaction, including: rash, itching/swelling||
5253|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5253|080|S|breathing.||
5253|081|S|   This is not a complete list of possible side effects. If you||
5253|082|S|notice other effects not listed above, contact your doctor or||
5253|083|S|pharmacist.||
5253|084|S|   In the US -||
5253|085|S|   Call your doctor for medical advice about side effects. You||
5253|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5253|087|S|www.fda.gov/medwatch.||
5253|088|S|   In Canada - Call your doctor for medical advice about side||
5253|089|S|effects. You may report side effects to Health Canada at||
5253|090|S|1-866-234-2345.||
5253|091|B|||
5253|092|P|PRECAUTIONS:  Before using clobetasol, tell your doctor or||
5253|093|P|pharmacist if you are allergic to it; or to any other steroids||
5253|094|P|(such as hydrocortisone, dexamethasone); or if you have any other||
5253|095|P|allergies. This product may contain inactive ingredients, which||
5253|096|P|can cause allergic reactions or other problems. Talk to your||
5253|097|P|pharmacist for more details.||
5253|098|P|   Before using this medication, tell your doctor or pharmacist||
5253|099|P|your medical history, especially of: poor blood circulation,||
5253|100|P|diabetes, other skin/scalp conditions (such as rosacea, perioral||
5253|101|P|dermatitis), immune system problems.||
5253|102|P|   Do not use if there is an infection or sore in the area to be||
5253|103|P|treated.||
5253|104|P|   Rarely, using corticosteroid medications for a long time or||
5253|105|P|over large areas of skin can make it more difficult for your body||
5253|106|P|to respond to physical stress. Before having surgery or emergency||
5253|107|P|treatment, or if you get a serious illness/injury, tell your||
5253|108|P|doctor or dentist that you are using this medication or have used||
5253|109|P|this medication within the past few months.||
5253|110|P|   Though it is unlikely, this medication may temporarily slow||
5253|111|P|down a child's growth if used for a long time. See the doctor||
5253|112|P|regularly so your child's height can be checked.||
5253|113|P|   During pregnancy, this medication should be used only when||
5253|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
5253|115|P|   It is unknown if this drug passes into breast milk when||
5253|116|P|applied to the scalp/skin. Similar medications pass into breast||
5253|117|P|milk when taken by mouth. Consult your doctor before||
5253|118|P|breastfeeding.||
5253|119|B|||
5253|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5253|121|I|medications work or increase your risk for serious side effects.||
5253|122|I|This document does not contain all possible drug interactions.||
5253|123|I|Keep a list of all the products you use (including||
5253|124|I|prescription/nonprescription drugs and herbal products) and share||
5253|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
5253|126|I|the dosage of any medicines without your doctor's approval.||
5253|127|B|||
5253|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5253|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5253|130|O|poison control center right away. US residents can call||
5253|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
5253|132|O|medicine may be harmful if swallowed.||
5253|133|B|||
5253|134|N|NOTES:  Do not share this medication with others. This medication||
5253|135|N|has been prescribed for your current condition only. Do not use||
5253|136|N|it later for other skin problems unless told to do so by your||
5253|137|N|doctor. A different medication may be necessary in those cases.||
5253|138|N|   Lab and/or medical tests (such as adrenal gland function) may||
5253|139|N|be done while you are using this medication, especially if you||
5253|140|N|use this drug for an extended period of time or apply it over||
5253|141|N|large areas of the body. Keep all medical and lab appointments.||
5253|142|N|Consult your doctor for more details.||
5253|143|B|||
5253|144|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5253|145|D|If it is near the time of the next dose, skip the missed dose.||
5253|146|D|Use your next dose at the regular time. Do not double the dose to||
5253|147|D|catch up.||
5253|148|B|||
5253|149|R|STORAGE:  Store at room temperature away from heat and open||
5253|150|R|flame. Keep all medications away from children and pets.||
5253|151|R|   Do not flush medications down the toilet or pour them into a||
5253|152|R|drain unless instructed to do so. Properly discard this product||
5253|153|R|when it is expired or no longer needed. Consult your pharmacist||
5253|154|R|or local waste disposal company.||
5253|155|B|||
5253|156|A|Information last revised May 2024.||
5253|157|A|Copyright(c) 2025 First Databank, Inc.||
5253|158|B|||
5262|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5262|002|Z|does NOT have all possible information about this product. This||
5262|003|Z|information does not assure that this product is safe, effective,||
5262|004|Z|or appropriate for you. This information is not individual||
5262|005|Z|medical advice and does not substitute for the advice of your||
5262|006|Z|health care professional. Always ask your health care||
5262|007|Z|professional for complete information about this product and your||
5262|008|Z|specific health needs.||
5262|009|B|||
5262|010|T|ITRACONAZOLE SOLUTION - ORAL||
5262|011|F|(IT-ra-KON-a-zole)||
5262|012|B|||
5262|013|C|COMMON BRAND NAME(S): Sporanox||
5262|014|B|||
5262|015|W|WARNING:  Itraconazole may rarely cause or worsen heart failure.||
5262|016|W|Tell your doctor right away if you develop symptoms of heart||
5262|017|W|failure, such as shortness of breath, swelling ankles/feet,||
5262|018|W|unusual tiredness, or unusual/sudden weight gain. Consult your||
5262|019|W|doctor for more details.||
5262|020|W|   This medication can slow down the removal of other medications||
5262|021|W|from your body, which may cause very serious (possibly fatal)||
5262|022|W|side effects to occur. Examples of affected drugs include certain||
5262|023|W|"blood thinners" (such as ticagrelor), colchicine, certain drugs||
5262|024|W|to treat irregular heartbeat (such disopyramide, dofetilide,||
5262|025|W|dronedarone, quinidine), eplerenone, ergot alkaloids (such as||
5262|026|W|dihydroergotamine, ergotamine, methylergonovine), felodipine,||
5262|027|W|fesoterodine, irinotecan, ivabradine, lurasidone, methadone,||
5262|028|W|midazolam, nisoldipine, pimozide, ranolazine, certain "statin"||
5262|029|W|cholesterol drugs (such as lovastatin, simvastatin), solifenacin,||
5262|030|W|telithromycin, triazolam, among others. Be sure to tell your||
5262|031|W|doctor and pharmacist about all the products you use (including||
5262|032|W|prescription drugs, nonprescription drugs, and herbal products).||
5262|033|B|||
5262|034|U|USES:  Itraconazole solution is used to treat fungal infections||
5262|035|U|in the mouth and throat. It belongs to a class of drugs known as||
5262|036|U|azole antifungals. It works by stopping the growth of fungi.||
5262|037|B|||
5262|038|V|OTHER USES:  This section contains uses of this drug that are not||
5262|039|V|listed in the approved professional labeling for the drug but||
5262|040|V|that may be prescribed by your health care professional. Use this||
5262|041|V|drug for a condition that is listed in this section only if it||
5262|042|V|has been so prescribed by your health care professional.||
5262|043|V|   This drug may also be used for other fungal infections.||
5262|044|B|||
5262|045|H|HOW TO USE:  Take this medication by mouth without food as||
5262|046|H|directed by your doctor, usually once or twice daily. Swish the||
5262|047|H|solution in your mouth for several seconds, and then swallow.||
5262|048|H|   The dosage and length of treatment are based on your medical||
5262|049|H|condition and response to treatment.||
5262|050|H|   For the best effect, take this antifungal at evenly spaced||
5262|051|H|times. To help you remember, take this medication at the same||
5262|052|H|time(s) every day.||
5262|053|H|   Continue to take this medication until the full prescribed||
5262|054|H|amount is finished, even if symptoms disappear after a few days.||
5262|055|H|Stopping the medication too early may result in a return of the||
5262|056|H|infection.||
5262|057|H|   The capsule, tablet, and solution forms of this medication||
5262|058|H|deliver different amounts of medication and may be used for||
5262|059|H|different purposes. Do not switch between the different forms or||
5262|060|H|brands of this drug without your doctor's direction.||
5262|061|H|   Tell your doctor if your condition does not get better or if||
5262|062|H|it gets worse.||
5262|063|B|||
5262|064|S|SIDE EFFECTS:  See also Warning section.||
5262|065|S|   Nausea/vomiting, diarrhea, headache, stomach upset, or||
5262|066|S|dizziness may occur. If any of these effects last or get worse,||
5262|067|S|tell your doctor or pharmacist promptly.||
5262|068|S|   Remember that this medication has been prescribed because your||
5262|069|S|doctor has judged that the benefit to you is greater than the||
5262|070|S|risk of side effects. Many people using this medication do not||
5262|071|S|have serious side effects.||
5262|072|S|   This medication may raise your blood pressure. Check your||
5262|073|S|blood pressure regularly and tell your doctor if the results are||
5262|074|S|high.||
5262|075|S|   Tell your doctor right away if you have any serious side||
5262|076|S|effects, including: numbness/tingling of arms/legs, hearing loss,||
5262|077|S|mental/mood changes (such as depression).||
5262|078|S|   Itraconazole has rarely caused very serious (possibly fatal)||
5262|079|S|liver disease. Tell your doctor right away if you develop||
5262|080|S|symptoms of liver disease, such as: nausea/vomiting that doesn't||
5262|081|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
5262|082|S|eyes/skin, dark urine.||
5262|083|S|   Itraconazole can commonly cause a mild rash that is usually||
5262|084|S|not serious. However, you may not be able to tell it apart from a||
5262|085|S|rare rash that could be a sign of a severe allergic reaction. Get||
5262|086|S|medical help right away if you develop any rash.||
5262|087|S|   A very serious allergic reaction to this drug is rare.||
5262|088|S|However, get medical help right away if you notice any symptoms||
5262|089|S|of a serious allergic reaction, including: rash, itching/swelling||
5262|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5262|091|S|breathing.||
5262|092|S|   This is not a complete list of possible side effects. If you||
5262|093|S|notice other effects not listed above, contact your doctor or||
5262|094|S|pharmacist.||
5262|095|S|   In the US -||
5262|096|S|   Call your doctor for medical advice about side effects. You||
5262|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5262|098|S|www.fda.gov/medwatch.||
5262|099|S|   In Canada - Call your doctor for medical advice about side||
5262|100|S|effects. You may report side effects to Health Canada at||
5262|101|S|1-866-234-2345.||
5262|102|B|||
5262|103|P|PRECAUTIONS:  Before taking itraconazole, tell your doctor or||
5262|104|P|pharmacist if you are allergic to it; or to other azole||
5262|105|P|antifungals (such as ketoconazole); or if you have any other||
5262|106|P|allergies. This product may contain inactive ingredients, which||
5262|107|P|can cause allergic reactions or other problems. Talk to your||
5262|108|P|pharmacist for more details.||
5262|109|P|   Before using this medication, tell your doctor or pharmacist||
5262|110|P|your medical history, especially of: heart disease (such as heart||
5262|111|P|failure, coronary artery disease, heart valve disease), liver||
5262|112|P|disease, kidney disease, lung disease (such as chronic||
5262|113|P|obstructive pulmonary disease-COPD).||
5262|114|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5262|115|P|can make you more dizzy. Do not drive, use machinery, or do||
5262|116|P|anything that needs alertness until you can do it safely. Avoid||
5262|117|P|alcoholic beverages. Talk to your doctor if you are using||
5262|118|P|marijuana (cannabis). Alcohol may also increase the risk of||
5262|119|P|serious liver problems.||
5262|120|P|   Before having surgery, tell your doctor or dentist about all||
5262|121|P|the products you use (including prescription drugs,||
5262|122|P|nonprescription drugs, and herbal products).||
5262|123|P|   Older adults may be at greater risk for hearing loss while||
5262|124|P|using this drug.||
5262|125|P|   During pregnancy, this medication should be used only when||
5262|126|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
5262|127|P|benefits with your doctor. Ask about reliable forms of birth||
5262|128|P|control while taking this medication and for 2 months after||
5262|129|P|stopping treatment.||
5262|130|P|   Itraconazole passes into breast milk. Consult your doctor||
5262|131|P|before breastfeeding.||
5262|132|B|||
5262|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5262|134|I|medications work or increase your risk for serious side effects.||
5262|135|I|This document does not contain all possible drug interactions.||
5262|136|I|Keep a list of all the products you use (including||
5262|137|I|prescription/nonprescription drugs and herbal products) and share||
5262|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
5262|139|I|the dosage of any medicines without your doctor's approval.||
5262|140|I|   Itraconazole interacts with many medications. See also Warning||
5262|141|I|section.||
5262|142|I|   Other medications can affect the removal of itraconazole from||
5262|143|I|your body, which may affect how itraconazole works. Examples||
5262|144|I|include efavirenz, isoniazid, nevirapine, rifamycins (such as||
5262|145|I|rifabutin), certain drugs used to treat seizures (such as||
5262|146|I|phenytoin), among others.||
5262|147|B|||
5262|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5262|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5262|150|O|poison control center right away. US residents can call||
5262|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5262|152|B|||
5262|153|N|NOTES:  Do not share this medication with others.||
5262|154|N|   This medication has been prescribed for your current condition||
5262|155|N|only. Do not use it later to treat or prevent another infection||
5262|156|N|unless your doctor tells you to.||
5262|157|N|   Lab and/or medical tests (such as liver function, potassium||
5262|158|N|level, blood pressure) should be done before you start taking||
5262|159|N|this medication and while you are taking it. Keep all medical and||
5262|160|N|lab appointments. Consult your doctor for more details.||
5262|161|B|||
5262|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5262|163|D|remember. If it is near the time of the next dose, skip the||
5262|164|D|missed dose. Take your next dose at the regular time. Do not||
5262|165|D|double the dose to catch up.||
5262|166|B|||
5262|167|R|STORAGE:  Different brands of this medication have different||
5262|168|R|storage needs. Check the product package for instructions on how||
5262|169|R|to store your brand, or ask your pharmacist. Keep all medications||
5262|170|R|away from children and pets.||
5262|171|R|   Do not flush medications down the toilet or pour them into a||
5262|172|R|drain unless instructed to do so. Properly discard this product||
5262|173|R|when it is expired or no longer needed. Consult your pharmacist||
5262|174|R|or local waste disposal company.||
5262|175|B|||
5262|176|A|Information last revised October 2024.||
5262|177|A|Copyright(c) 2025 First Databank, Inc.||
5262|178|B|||
5269|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5269|002|Z|does NOT have all possible information about this product. This||
5269|003|Z|information does not assure that this product is safe, effective,||
5269|004|Z|or appropriate for you. This information is not individual||
5269|005|Z|medical advice and does not substitute for the advice of your||
5269|006|Z|health care professional. Always ask your health care||
5269|007|Z|professional for complete information about this product and your||
5269|008|Z|specific health needs.||
5269|009|B|||
5269|010|T|CEFUROXIME SUSPENSION - ORAL||
5269|011|F|(sef-you-ROX-eem)||
5269|012|B|||
5269|013|C|COMMON BRAND NAME(S): Ceftin||
5269|014|B|||
5269|015|U|USES:  Cefuroxime is used to treat a wide variety of bacterial||
5269|016|U|infections. This medication is known as a cephalosporin||
5269|017|U|antibiotic. It works by stopping the growth of bacteria.||
5269|018|U|   This antibiotic treats only bacterial infections. It will not||
5269|019|U|work for viral infections (such as common cold, flu). Using any||
5269|020|U|antibiotic when it is not needed can cause it to not work for||
5269|021|U|future infections.||
5269|022|B|||
5269|023|H|HOW TO USE:  Shake the bottle well before each dose. Measure the||
5269|024|H|dose out carefully with a medication spoon/cup. Take this||
5269|025|H|medication by mouth with food as directed by your doctor, usually||
5269|026|H|twice daily (every 12 hours). The dosage is based on your medical||
5269|027|H|condition and response to treatment. Children's dosage is also||
5269|028|H|based on weight.||
5269|029|H|   For the best effect, take this antibiotic at evenly spaced||
5269|030|H|times. To help you remember, take this medication at the same||
5269|031|H|time(s) every day.||
5269|032|H|   Continue to take this medication until the full prescribed||
5269|033|H|amount is finished, even if symptoms disappear after a few days.||
5269|034|H|Stopping the medication too early may result in a return of the||
5269|035|H|infection.||
5269|036|H|   Tell your doctor if your condition lasts or gets worse.||
5269|037|B|||
5269|038|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, strange taste in the||
5269|039|S|mouth, or stomach pain may occur. Diaper rash may occur in young||
5269|040|S|children. Dizziness and drowsiness may occur less often,||
5269|041|S|especially with higher doses. If any of these effects last or get||
5269|042|S|worse, tell your doctor or pharmacist promptly.||
5269|043|S|   Remember that this medication has been prescribed because your||
5269|044|S|doctor has judged that the benefit to you is greater than the||
5269|045|S|risk of side effects. Many people using this medication do not||
5269|046|S|have serious side effects.||
5269|047|S|   Tell your doctor right away if you have any serious side||
5269|048|S|effects, including: unusual tiredness/weakness, signs of liver||
5269|049|S|problems (such as nausea/vomiting that doesn't stop,||
5269|050|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
5269|051|S|of kidney problems (such as change in the amount of urine), signs||
5269|052|S|of new infection (such as sore throat that doesn't go away,||
5269|053|S|fever), easy bruising/bleeding, jerky movements, mental/mood||
5269|054|S|changes (such as confusion).||
5269|055|S|   This medication may rarely cause a severe intestinal condition||
5269|056|S|due to a bacteria called C. difficile. This condition may occur||
5269|057|S|during treatment or weeks to months after treatment has stopped.||
5269|058|S|Tell your doctor right away if you develop: diarrhea that doesn't||
5269|059|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
5269|060|S|stool.||
5269|061|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
5269|062|S|products because they may make symptoms worse.||
5269|063|S|   Use of this medication for prolonged or repeated periods may||
5269|064|S|result in oral thrush or a new vaginal yeast infection (oral or||
5269|065|S|vaginal fungal infection). Contact your doctor if you notice||
5269|066|S|white patches in your mouth, a change in vaginal discharge or||
5269|067|S|other new symptoms.||
5269|068|S|   A very serious allergic reaction to this drug is rare.||
5269|069|S|However, get medical help right away if you notice any symptoms||
5269|070|S|of a serious allergic reaction, including: rash, itching/swelling||
5269|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5269|072|S|breathing.||
5269|073|S|   This is not a complete list of possible side effects. If you||
5269|074|S|notice other effects not listed above, contact your doctor or||
5269|075|S|pharmacist.||
5269|076|S|   In the US -||
5269|077|S|   Call your doctor for medical advice about side effects. You||
5269|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5269|079|S|www.fda.gov/medwatch.||
5269|080|S|   In Canada - Call your doctor for medical advice about side||
5269|081|S|effects. You may report side effects to Health Canada at||
5269|082|S|1-866-234-2345.||
5269|083|B|||
5269|084|P|PRECAUTIONS:  Before taking cefuroxime, tell your doctor or||
5269|085|P|pharmacist if you are allergic to it; or to penicillins or other||
5269|086|P|cephalosporin antibiotics (such as cephalexin); or if you have||
5269|087|P|any other allergies. This product may contain inactive||
5269|088|P|ingredients, which can cause allergic reactions or other||
5269|089|P|problems. Talk to your pharmacist for more details.||
5269|090|P|   Before using this medication, tell your doctor or pharmacist||
5269|091|P|your medical history, especially of: kidney disease, intestinal||
5269|092|P|disease (colitis), liver disease, poor nutrition.||
5269|093|P|   This medicine may contain aspartame. If you have||
5269|094|P|phenylketonuria (PKU) or any other condition where you must||
5269|095|P|restrict your intake of aspartame (or phenylalanine), consult||
5269|096|P|your doctor or pharmacist regarding the safe use of this||
5269|097|P|medicine.||
5269|098|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5269|099|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5269|100|P|machinery, or do anything that needs alertness until you can do||
5269|101|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5269|102|P|are using marijuana (cannabis).||
5269|103|P|   Cefuroxime may cause live bacterial vaccines (such as typhoid||
5269|104|P|vaccine) to not work well. Tell your health care professional||
5269|105|P|that you are using cefuroxime before having any||
5269|106|P|immunizations/vaccinations.||
5269|107|P|   Before having surgery, tell your doctor or dentist about all||
5269|108|P|the products you use (including prescription drugs,||
5269|109|P|nonprescription drugs, and herbal products).||
5269|110|P|   Older adults may be more sensitive to the side effects of this||
5269|111|P|drug.||
5269|112|P|   During pregnancy, this medication should be used only when||
5269|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
5269|114|P|   This medication passes into breast milk. Consult your doctor||
5269|115|P|before breastfeeding.||
5269|116|B|||
5269|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5269|118|I|medications work or increase your risk for serious side effects.||
5269|119|I|This document does not contain all possible drug interactions.||
5269|120|I|Keep a list of all the products you use (including||
5269|121|I|prescription/nonprescription drugs and herbal products) and share||
5269|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
5269|123|I|the dosage of any medicines without your doctor's approval.||
5269|124|I|   This medication may interfere with certain lab tests (such as||
5269|125|I|certain diabetic urine tests, blood glucose tests), possibly||
5269|126|I|causing false test results. Make sure lab personnel and all your||
5269|127|I|doctors know you use this drug.||
5269|128|B|||
5269|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5269|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5269|131|O|poison control center right away. US residents can call||
5269|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5269|133|O|Symptoms of overdose may include seizures.||
5269|134|B|||
5269|135|N|NOTES:  Do not share this medication with others.||
5269|136|N|   This medication has been prescribed for your current condition||
5269|137|N|only. Do not use it later for another infection unless your||
5269|138|N|doctor tells you to.||
5269|139|B|||
5269|140|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5269|141|D|remember. If it is near the time of the next dose, skip the||
5269|142|D|missed dose. Take your next dose at the regular time. Do not||
5269|143|D|double the dose to catch up.||
5269|144|B|||
5269|145|R|STORAGE:  Store the suspension in a refrigerator. Do not freeze.||
5269|146|R|Discard any unused medication after 10 days. Keep all medications||
5269|147|R|away from children and pets.||
5269|148|R|   Do not flush medications down the toilet or pour them into a||
5269|149|R|drain unless instructed to do so. Properly discard this product||
5269|150|R|when it is expired or no longer needed. Consult your pharmacist||
5269|151|R|or local waste disposal company.||
5269|152|B|||
5269|153|A|Information last revised August 2024.||
5269|154|A|Copyright(c) 2025 First Databank, Inc.||
5269|155|B|||
5273|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5273|002|Z|does NOT have all possible information about this product. This||
5273|003|Z|information does not assure that this product is safe, effective,||
5273|004|Z|or appropriate for you. This information is not individual||
5273|005|Z|medical advice and does not substitute for the advice of your||
5273|006|Z|health care professional. Always ask your health care||
5273|007|Z|professional for complete information about this product and your||
5273|008|Z|specific health needs.||
5273|009|B|||
5273|010|T|TOPOTECAN - INJECTION||
5273|011|F|(TOE-poe-TEE-kan)||
5273|012|B|||
5273|013|C|COMMON BRAND NAME(S): Hycamtin||
5273|014|B|||
5273|015|W|WARNING:  Topotecan decreases bone marrow function, an effect||
5273|016|W|that may lead to a low number of blood cells such as red cells,||
5273|017|W|white cells, and platelets. This effect can cause anemia,||
5273|018|W|decrease your body's ability to fight an infection, or cause easy||
5273|019|W|bruising/bleeding. Tell your doctor right away if you develop any||
5273|020|W|of the following symptoms: unusual tiredness, pale skin, signs of||
5273|021|W|infection (such as sore throat that doesn't go away, fever,||
5273|022|W|chills), easy bruising/bleeding.||
5273|023|W|   Your doctor will order blood tests to monitor your bone marrow||
5273|024|W|function while you are using this medication. Keep all medical||
5273|025|W|and lab appointments.||
5273|026|B|||
5273|027|U|USES:  This medication is used to treat ovarian, lung, or||
5273|028|U|cervical cancer. It is a chemotherapy drug that works by slowing||
5273|029|U|or stopping the growth of cancer cells.||
5273|030|B|||
5273|031|V|OTHER USES:  This section contains uses of this drug that are not||
5273|032|V|listed in the approved professional labeling for the drug but||
5273|033|V|that may be prescribed by your health care professional. Use this||
5273|034|V|drug for a condition that is listed in this section only if it||
5273|035|V|has been so prescribed by your health care professional.||
5273|036|V|   This drug may also be used for other types of cancer (such as||
5273|037|V|bone cancer).||
5273|038|B|||
5273|039|H|HOW TO USE:  This medication is given by a health care||
5273|040|H|professional. It is injected slowly into a vein over 30 minutes.||
5273|041|H|The dosage is based on your medical condition, body size, lab||
5273|042|H|tests, and response to treatment.||
5273|043|B|||
5273|044|S|SIDE EFFECTS:  See also Warning section.||
5273|045|S|   Nausea, vomiting, constipation, diarrhea, abdominal pain,||
5273|046|S|weakness, tiredness, or mouth sores may occur. If any of these||
5273|047|S|effects last or get worse, tell your doctor or pharmacist||
5273|048|S|promptly.||
5273|049|S|   People using this medication may have serious side effects.||
5273|050|S|However, you have been prescribed this drug because your doctor||
5273|051|S|has judged that the benefit to you is greater than the risk of||
5273|052|S|side effects. Careful monitoring by your doctor may decrease your||
5273|053|S|risk.||
5273|054|S|   Tell your doctor right away if you have any serious side||
5273|055|S|effects, including: pain/redness/bruising at injection site,||
5273|056|S|signs of lung problems (such as cough, shortness of breath).||
5273|057|S|   A very serious allergic reaction to this drug is rare.||
5273|058|S|However, get medical help right away if you notice any symptoms||
5273|059|S|of a serious allergic reaction, including: rash, itching/swelling||
5273|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5273|061|S|breathing.||
5273|062|S|   This is not a complete list of possible side effects. If you||
5273|063|S|notice other effects not listed above, contact your doctor or||
5273|064|S|pharmacist.||
5273|065|S|   In the US -||
5273|066|S|   Call your doctor for medical advice about side effects. You||
5273|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5273|068|S|www.fda.gov/medwatch.||
5273|069|S|   In Canada - Call your doctor for medical advice about side||
5273|070|S|effects. You may report side effects to Health Canada at||
5273|071|S|1-866-234-2345.||
5273|072|B|||
5273|073|P|PRECAUTIONS:  Before using topotecan, tell your doctor or||
5273|074|P|pharmacist if you are allergic to it; or if you have any other||
5273|075|P|allergies. This product may contain inactive ingredients, which||
5273|076|P|can cause allergic reactions or other problems. Talk to your||
5273|077|P|pharmacist for more details.||
5273|078|P|   Before using this medication, tell your doctor or pharmacist||
5273|079|P|your medical history, especially of: kidney disease.||
5273|080|P|   This drug may make you feel weak or tired. Alcohol or||
5273|081|P|marijuana (cannabis) can make you more tired. Do not drive, use||
5273|082|P|machinery, or do anything that needs alertness until you can do||
5273|083|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5273|084|P|are using marijuana (cannabis).||
5273|085|P|   Topotecan can make you more likely to get infections or may||
5273|086|P|make current infections worse. Stay away from anyone who has an||
5273|087|P|infection that may easily spread (such as chickenpox, COVID-19,||
5273|088|P|measles, flu). Talk to your doctor if you have been exposed to an||
5273|089|P|infection or for more details.||
5273|090|P|   Tell your health care professional that you are using||
5273|091|P|topotecan before having any immunizations/vaccinations. Avoid||
5273|092|P|contact with people who have recently received live vaccines||
5273|093|P|(such as flu vaccine inhaled through the nose).||
5273|094|P|   To lower the chance of getting cut, bruised or injured, use||
5273|095|P|caution with sharp objects like razors and nail cutters, and||
5273|096|P|avoid activities such as contact sports.||
5273|097|P|   Before having surgery, tell your doctor or dentist about all||
5273|098|P|the products you use (including prescription drugs,||
5273|099|P|nonprescription drugs, and herbal products).||
5273|100|P|   This medication can affect fertility in both males and||
5273|101|P|females. Ask your doctor for more details.||
5273|102|P|   Tell your doctor if you are pregnant or plan to become||
5273|103|P|pregnant. You should not become pregnant while using topotecan.||
5273|104|P|Topotecan may harm an unborn baby. Women using this medication||
5273|105|P|should ask about reliable forms of birth control during treatment||
5273|106|P|and for 6 months after the last dose. Men using this medication||
5273|107|P|should ask about reliable forms of birth control during treatment||
5273|108|P|and for 3 months after the last dose. If you or your partner||
5273|109|P|becomes pregnant, talk to your doctor right away about the risks||
5273|110|P|and benefits of this medication.||
5273|111|P|   It is unknown if this drug passes into breast milk. Because of||
5273|112|P|the possible risk to the infant, breastfeeding is not recommended||
5273|113|P|while using this drug and for 1 week after the last dose. Consult||
5273|114|P|your doctor before breastfeeding.||
5273|115|B|||
5273|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5273|117|I|medications work or increase your risk for serious side effects.||
5273|118|I|This document does not contain all possible drug interactions.||
5273|119|I|Keep a list of all the products you use (including||
5273|120|I|prescription/nonprescription drugs and herbal products) and share||
5273|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
5273|122|I|the dosage of any medicines without your doctor's approval.||
5273|123|B|||
5273|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5273|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5273|126|O|poison control center right away. US residents can call||
5273|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5273|128|B|||
5273|129|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
5273|130|N|kidney/liver function) should be done while you are using this||
5273|131|N|medication. Keep all medical and lab appointments. Consult your||
5273|132|N|doctor for more details.||
5273|133|B|||
5273|134|D|MISSED DOSE:  It is important to get each dose of this medication||
5273|135|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
5273|136|D|right away for a new dosing schedule.||
5273|137|B|||
5273|138|R|STORAGE:  Not applicable. This medication is given in a clinic||
5273|139|R|and will not be stored at home.||
5273|140|B|||
5273|141|M|MEDICAL ALERT:  Your condition can cause complications in a||
5273|142|M|medical emergency. For information about enrolling in MedicAlert,||
5273|143|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5273|144|B|||
5273|145|A|Information last revised May 2024.||
5273|146|A|Copyright(c) 2025 First Databank, Inc.||
5273|147|B|||
5274|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5274|002|Z|does NOT have all possible information about this product. This||
5274|003|Z|information does not assure that this product is safe, effective,||
5274|004|Z|or appropriate for you. This information is not individual||
5274|005|Z|medical advice and does not substitute for the advice of your||
5274|006|Z|health care professional. Always ask your health care||
5274|007|Z|professional for complete information about this product and your||
5274|008|Z|specific health needs.||
5274|009|B|||
5274|010|T|ZIPRASIDONE - INJECTION||
5274|011|F|(zih-PRASS-ih-doan)||
5274|012|B|||
5274|013|C|COMMON BRAND NAME(S): Geodon||
5274|014|B|||
5274|015|W|WARNING:  There may be a slightly increased risk of serious,||
5274|016|W|possibly fatal side effects (such as stroke, heart failure,||
5274|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
5274|018|W|by older adults with dementia. This medication is not approved||
5274|019|W|for the treatment of dementia-related behavior problems. Discuss||
5274|020|W|the risks and benefits of this medication, as well as other||
5274|021|W|effective and possibly safer treatments for dementia-related||
5274|022|W|behavior problems, with the doctor.||
5274|023|B|||
5274|024|U|USES:  This medication is used to treat severe agitation||
5274|025|U|associated with a certain mental/mood disorder (schizophrenia).||
5274|026|U|Ziprasidone belongs to a class of drugs known as atypical||
5274|027|U|antipsychotics. It works by helping to restore the balance of||
5274|028|U|certain natural substances in the brain.||
5274|029|U|   Ziprasidone injection is used when quick relief of your||
5274|030|U|symptoms is required. It is not used together with the form of||
5274|031|U|this medication that is taken by mouth.||
5274|032|B|||
5274|033|H|HOW TO USE:  This medication is given by injection into a muscle||
5274|034|H|by a healthcare professional. The dose and frequency of use will||
5274|035|H|depend on your condition and response to treatment.||
5274|036|H|   This medication is intended for short-term control of severe||
5274|037|H|occurrences of agitation. If you require continuous treatment for||
5274|038|H|your condition, your doctor may switch you to an oral medication.||
5274|039|B|||
5274|040|S|SIDE EFFECTS:  Pain, swelling and redness at the injection site||
5274|041|S|may occur. Drowsiness, dizziness, lightheadedness, weakness,||
5274|042|S|nausea, vomiting, and headache may also occur. If any of these||
5274|043|S|effects last or get worse, tell your doctor or pharmacist||
5274|044|S|promptly.||
5274|045|S|   Dizziness and lightheadedness can increase the risk of||
5274|046|S|falling. Get up slowly when rising from a sitting or lying||
5274|047|S|position.||
5274|048|S|   Remember that this medication has been prescribed because your||
5274|049|S|doctor has judged that the benefit to you is greater than the||
5274|050|S|risk of side effects. Many people using this medication do not||
5274|051|S|have serious side effects.||
5274|052|S|   Tell your doctor right away if you have any serious side||
5274|053|S|effects, including: mental/mood changes (such as restlessness),||
5274|054|S|shaking (tremors), muscle spasms, difficulty swallowing, vision||
5274|055|S|problems, interrupted breathing during sleep.||
5274|056|S|   This drug may rarely make your blood sugar rise, which can||
5274|057|S|cause or worsen diabetes. Tell your doctor right away if you have||
5274|058|S|symptoms of high blood sugar such as increased thirst/urination.||
5274|059|S|If you already have diabetes, check your blood sugar regularly as||
5274|060|S|directed and share the results with your doctor. Your doctor may||
5274|061|S|need to adjust your diabetes medication, exercise program, or||
5274|062|S|diet.||
5274|063|S|   This drug may also rarely cause significant weight gain and a||
5274|064|S|rise in your blood cholesterol (or triglyceride) levels. These||
5274|065|S|effects, along with diabetes, may increase your risk for||
5274|066|S|developing heart disease. Discuss the risks and benefits of||
5274|067|S|treatment with your doctor.||
5274|068|S|   This drug may rarely cause a condition known as tardive||
5274|069|S|dyskinesia. In some cases, this condition may be permanent. Tell||
5274|070|S|your doctor right away if you develop any unusual uncontrolled||
5274|071|S|movements (especially of the face, mouth, tongue, arms or legs).||
5274|072|S|   This medication may increase a certain natural substance||
5274|073|S|(prolactin) made by your body. For females, this increase in||
5274|074|S|prolactin may result in unwanted breast milk, missed/stopped||
5274|075|S|periods, or difficulty becoming pregnant. For males, it may||
5274|076|S|result in decreased sexual ability, inability to produce sperm,||
5274|077|S|or enlarged breasts. If you develop any of these symptoms, tell||
5274|078|S|your doctor right away.||
5274|079|S|   Get medical help right away if you have any very serious side||
5274|080|S|effects, including: severe dizziness, fainting, seizures, signs||
5274|081|S|of liver damage (such as nausea/vomiting that doesn't stop, loss||
5274|082|S|of appetite, stomach/abdominal pain, yellowing eyes/skin).||
5274|083|S|   This medication may increase serotonin and rarely cause a very||
5274|084|S|serious condition called serotonin syndrome/toxicity. The risk||
5274|085|S|increases if you are also taking other drugs that increase||
5274|086|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
5274|087|S|take (see Drug Interactions section). Get medical help right away||
5274|088|S|if you develop some of the following symptoms: fast heartbeat,||
5274|089|S|hallucinations, loss of coordination, severe dizziness, severe||
5274|090|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
5274|091|S|unusual agitation/restlessness.||
5274|092|S|   This medication may rarely cause a very serious condition||
5274|093|S|called neuroleptic malignant syndrome (NMS). Get medical help||
5274|094|S|right away if you have any of the following symptoms: fever,||
5274|095|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
5274|096|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
5274|097|S|signs of kidney problems (such as change in the amount of urine).||
5274|098|S|   Rarely, males may have a painful or prolonged erection lasting||
5274|099|S|4 or more hours. If this occurs, stop using this drug and get||
5274|100|S|medical help right away, or permanent problems could occur.||
5274|101|S|   A very serious allergic reaction to this drug is rare.||
5274|102|S|However, get medical help right away if you notice any symptoms||
5274|103|S|of a serious allergic reaction, including: fever, swollen lymph||
5274|104|S|nodes, rash, itching/swelling (especially of the||
5274|105|S|face/tongue/throat), severe dizziness, trouble breathing.||
5274|106|S|   This is not a complete list of possible side effects. If you||
5274|107|S|notice other effects not listed above, contact your doctor or||
5274|108|S|pharmacist.||
5274|109|S|   In the US -||
5274|110|S|   Call your doctor for medical advice about side effects. You||
5274|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5274|112|S|www.fda.gov/medwatch.||
5274|113|S|   In Canada - Call your doctor for medical advice about side||
5274|114|S|effects. You may report side effects to Health Canada at||
5274|115|S|1-866-234-2345.||
5274|116|B|||
5274|117|P|PRECAUTIONS:  Before using ziprasidone, tell your doctor or||
5274|118|P|pharmacist if you are allergic to it; or if you have any other||
5274|119|P|allergies. This product may contain inactive ingredients, which||
5274|120|P|can cause allergic reactions or other problems. Talk to your||
5274|121|P|pharmacist for more details.||
5274|122|P|   Before using this medication, tell your doctor or pharmacist||
5274|123|P|your medical history, especially of: dementia, heart disease||
5274|124|P|(such as coronary artery disease, irregular heartbeat), diabetes||
5274|125|P|(including family history), seizures, obesity, difficulty||
5274|126|P|swallowing, low white blood cell count, kidney disease, breathing||
5274|127|P|trouble during sleep (sleep apnea).||
5274|128|P|   Ziprasidone may cause a condition that affects the heart||
5274|129|P|rhythm (QT prolongation). QT prolongation can rarely cause||
5274|130|P|serious (rarely fatal) fast/irregular heartbeat and other||
5274|131|P|symptoms (such as severe dizziness, fainting) that need medical||
5274|132|P|attention right away.||
5274|133|P|   The risk of QT prolongation may be increased if you have||
5274|134|P|certain medical conditions or are taking other drugs that may||
5274|135|P|cause QT prolongation. Before using ziprasidone, tell your doctor||
5274|136|P|or pharmacist of all the drugs you take and if you have any of||
5274|137|P|the following conditions: certain heart problems (heart failure,||
5274|138|P|slow heartbeat, QT prolongation in the EKG), family history of||
5274|139|P|certain heart problems (QT prolongation in the EKG, sudden||
5274|140|P|cardiac death).||
5274|141|P|   Low levels of potassium or magnesium in the blood may also||
5274|142|P|increase your risk of QT prolongation. This risk may increase if||
5274|143|P|you use certain drugs (such as diuretics/"water pills") or if you||
5274|144|P|have conditions such as severe sweating, diarrhea, or vomiting.||
5274|145|P|Talk to your doctor about using ziprasidone safely.||
5274|146|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5274|147|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5274|148|P|machinery, or do anything that needs alertness until you can do||
5274|149|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5274|150|P|are using marijuana (cannabis).||
5274|151|P|   Before having surgery, tell your doctor or dentist about all||
5274|152|P|the products you use (including prescription drugs,||
5274|153|P|nonprescription drugs, and herbal products).||
5274|154|P|   This medication may make you sweat less, making you more||
5274|155|P|likely to get heat stroke. Avoid doing things that may cause you||
5274|156|P|to overheat, such as hard work or exercise in hot weather, or||
5274|157|P|using hot tubs. When the weather is hot, drink a lot of fluids||
5274|158|P|and dress lightly. If you overheat, quickly look for a place to||
5274|159|P|cool down and rest. Get medical help right away if you have a||
5274|160|P|fever that does not go away, mental/mood changes, headache, or||
5274|161|P|dizziness.||
5274|162|P|   Older adults may be more sensitive to the side effects of this||
5274|163|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
5274|164|P|prolongation (see above). Drowsiness, dizziness, and||
5274|165|P|lightheadedness can increase the risk of falling.||
5274|166|P|   During pregnancy, this medication should be used only when||
5274|167|P|clearly needed. Babies born to mothers who have used this drug||
5274|168|P|during the last 3 months of pregnancy may rarely develop symptoms||
5274|169|P|including muscle stiffness or shakiness, drowsiness,||
5274|170|P|feeding/breathing difficulties, or constant crying. If you notice||
5274|171|P|any of these symptoms in your newborn especially during their||
5274|172|P|first month, tell the doctor right away.||
5274|173|P|   Since untreated mental/mood problems (such as schizophrenia)||
5274|174|P|can be a serious condition, do not stop taking this medication||
5274|175|P|unless directed by your doctor. If you are planning pregnancy,||
5274|176|P|become pregnant, or think you may be pregnant, immediately||
5274|177|P|discuss with your doctor the benefits and risks of using this||
5274|178|P|medication during pregnancy.||
5274|179|P|   It is unknown if this drug passes into breast milk. Because of||
5274|180|P|the possible risk to the infant, breastfeeding is not recommended||
5274|181|P|while using this drug. Consult your doctor before breastfeeding.||
5274|182|B|||
5274|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5274|184|I|medications work or increase your risk for serious side effects.||
5274|185|I|This document does not contain all possible drug interactions.||
5274|186|I|Keep a list of all the products you use (including||
5274|187|I|prescription/nonprescription drugs and herbal products) and share||
5274|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
5274|189|I|the dosage of any medicines without your doctor's approval.||
5274|190|I|   Some products that may interact with this drug are:||
5274|191|I|dolasetron, metoclopramide.||
5274|192|I|   The risk of serotonin syndrome/toxicity increases if you are||
5274|193|I|also taking other drugs that increase serotonin. Examples include||
5274|194|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
5274|195|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
5274|196|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
5274|197|I|serotonin syndrome/toxicity may be more likely when you start or||
5274|198|I|increase the dose of these drugs.||
5274|199|I|   Taking MAO inhibitors with this medication may cause a serious||
5274|200|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
5274|201|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
5274|202|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
5274|203|I|selegiline, tranylcypromine) during treatment with this||
5274|204|I|medication. Most MAO inhibitors should also not be taken for two||
5274|205|I|weeks before and aftertreatment with this medication. Ask your||
5274|206|I|doctor when to start or stop taking this medication.||
5274|207|I|   Many drugs besides ziprasidone may affect the heart rhythm (QT||
5274|208|I|prolongation), including amiodarone, dofetilide, moxifloxacin,||
5274|209|I|pimozide, procainamide, quinidine, sotalol, tacrolimus,||
5274|210|I|thioridazine, among others.||
5274|211|I|   Tell your doctor or pharmacist if you are taking other||
5274|212|I|products that cause drowsiness such as opioid pain or cough||
5274|213|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5274|214|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5274|215|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5274|216|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5274|217|I|diphenhydramine).||
5274|218|I|   Check the labels on all your medicines (such as allergy or||
5274|219|I|cough-and-cold products) because they may contain ingredients||
5274|220|I|that cause drowsiness. Ask your pharmacist about using those||
5274|221|I|products safely.||
5274|222|B|||
5274|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5274|224|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5274|225|O|poison control center right away. US residents can call||
5274|226|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5274|227|O|Symptoms of overdose may include: severe drowsiness,||
5274|228|O|unusual/uncontrolled movements.||
5274|229|B|||
5274|230|N|NOTES:  Lab and/or medical tests (such as blood mineral levels,||
5274|231|N|blood sugar, weight) should be done while you are using this||
5274|232|N|medication. Keep all medical and lab appointments. Consult your||
5274|233|N|doctor for more details.||
5274|234|B|||
5274|235|D|MISSED DOSE:  Not applicable.||
5274|236|B|||
5274|237|R|STORAGE:  Not applicable. This medication is given in a hospital||
5274|238|R|and will not be stored at home.||
5274|239|B|||
5274|240|A|Information last revised February 2025.||
5274|241|A|Copyright(c) 2025 First Databank, Inc.||
5274|242|B|||
5278|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5278|002|Z|does NOT have all possible information about this product. This||
5278|003|Z|information does not assure that this product is safe, effective,||
5278|004|Z|or appropriate for you. This information is not individual||
5278|005|Z|medical advice and does not substitute for the advice of your||
5278|006|Z|health care professional. Always ask your health care||
5278|007|Z|professional for complete information about this product and your||
5278|008|Z|specific health needs.||
5278|009|B|||
5278|010|T|OXYCODONE - ORAL||
5278|011|F|(ox-ee-KOH-doan)||
5278|012|B|||
5278|013|C|COMMON BRAND NAME(S): Roxicodone||
5278|014|B|||
5278|015|W|WARNING:  Oxycodone has a risk for abuse and addiction, which can||
5278|016|W|lead to overdose and death. Oxycodone may also cause severe,||
5278|017|W|possibly fatal, breathing problems. To lower your risk, your||
5278|018|W|doctor should have you take the smallest dose of oxycodone that||
5278|019|W|works, and take it for the shortest possible time. See also How||
5278|020|W|to Use section for more information about addiction.||
5278|021|W|   Ask your doctor or pharmacist if you should have medication||
5278|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
5278|023|W|Teach your family or household members about the signs of an||
5278|024|W|opioid overdose and how to treat it.||
5278|025|W|   The risk for severe breathing problems is higher when you||
5278|026|W|start this medication and after a dose increase, or if you take||
5278|027|W|the wrong dose/strength. Taking this medication with alcohol or||
5278|028|W|other drugs that can cause drowsiness or breathing problems may||
5278|029|W|cause very serious side effects, including death. Also, other||
5278|030|W|medications can affect the removal of oxycodone from your body,||
5278|031|W|which may affect how oxycodone works. Be sure you know how to||
5278|032|W|take oxycodone and what other drugs you should avoid taking with||
5278|033|W|it. See also Drug Interactions section. Get medical help right||
5278|034|W|away if any of these very serious side effects occur:||
5278|035|W|slow/shallow breathing, unusual lightheadedness, severe||
5278|036|W|drowsiness/dizziness, difficulty waking up.||
5278|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
5278|038|W|or abuse. If someone accidentally swallows this drug, get medical||
5278|039|W|help right away.||
5278|040|W|   Before using this medication, women of childbearing age should||
5278|041|W|talk with their doctor(s) about the risks and benefits. Tell your||
5278|042|W|doctor if you are pregnant or if you plan to become pregnant.||
5278|043|W|During pregnancy, this medication should be used only when||
5278|044|W|clearly needed. It may slightly increase the risk of birth||
5278|045|W|defects if used during the first two months of pregnancy. Also,||
5278|046|W|using it for a long time or in high doses near the expected||
5278|047|W|delivery date may harm the unborn baby. To lessen the risk, take||
5278|048|W|the smallest effective dose for the shortest possible time.||
5278|049|W|Babies born to mothers who use this drug for a long time may||
5278|050|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
5278|051|W|doctor right away if you notice any symptoms in your newborn baby||
5278|052|W|such as crying that doesn't stop, slow/shallow breathing,||
5278|053|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
5278|054|W|difficulty gaining weight.||
5278|055|B|||
5278|056|U|USES:  This medication is used to help relieve moderate to severe||
5278|057|U|pain. Oxycodone belongs to a class of drugs known as opioid||
5278|058|U|analgesics. It works in the brain to change how your body feels||
5278|059|U|and responds to pain.||
5278|060|B|||
5278|061|H|HOW TO USE:  Read the Medication Guide provided by your||
5278|062|H|pharmacist before you start taking oxycodone and each time you||
5278|063|H|get a refill. If you have any questions, ask your doctor or||
5278|064|H|pharmacist.||
5278|065|H|   Take this medication by mouth as directed by your doctor. You||
5278|066|H|may take this drug with or without food. If you have nausea, it||
5278|067|H|may help to take this drug with food. Ask your doctor or||
5278|068|H|pharmacist about other ways to decrease nausea (such as lying||
5278|069|H|down for 1 to 2 hours with as little head movement as possible).||
5278|070|H|   Avoid eating grapefruit or drinking grapefruit juice while||
5278|071|H|using this medication unless your doctor or pharmacist says you||
5278|072|H|may do so safely. Grapefruit can increase the chance of side||
5278|073|H|effects with this medicine. Ask your doctor or pharmacist for||
5278|074|H|more details.||
5278|075|H|   If you are using the liquid form of this medication, carefully||
5278|076|H|measure the dose using a special measuring device/spoon. Do not||
5278|077|H|use a household spoon because you may not get the correct dose.||
5278|078|H|Ask your doctor or pharmacist if you are not sure how to check or||
5278|079|H|measure the dose.||
5278|080|H|   The dosage is based on your medical condition and response to||
5278|081|H|treatment. Do not increase your dose, take the medication more||
5278|082|H|often, or take it for a longer time than prescribed. Properly||
5278|083|H|stop the medication when so directed.||
5278|084|H|   Pain medications work best if they are used when the first||
5278|085|H|signs of pain occur. If you wait until the pain has worsened, the||
5278|086|H|medication may not work as well.||
5278|087|H|   If you have ongoing pain (such as due to cancer), your doctor||
5278|088|H|may direct you to also take long-acting opioid medications. In||
5278|089|H|that case, this medication might be used for sudden||
5278|090|H|(breakthrough) pain only as needed. Other pain relievers (such as||
5278|091|H|acetaminophen, ibuprofen) may also be prescribed with this||
5278|092|H|medication. Ask your doctor or pharmacist about using oxycodone||
5278|093|H|safely with other drugs.||
5278|094|H|   Suddenly stopping this medication may cause withdrawal,||
5278|095|H|especially if you have used it for a long time or in high doses.||
5278|096|H|To prevent withdrawal, your doctor may lower your dose slowly.||
5278|097|H|Tell your doctor or pharmacist right away if you have any||
5278|098|H|withdrawal symptoms such as restlessness, mental/mood changes||
5278|099|H|(including anxiety, trouble sleeping, thoughts of suicide),||
5278|100|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
5278|101|H|aches, or sudden changes in behavior.||
5278|102|H|   When this medication is used for a long time, it may not work||
5278|103|H|as well. Talk with your doctor if this medication stops working||
5278|104|H|well.||
5278|105|H|   Though it helps many people, this medication may sometimes||
5278|106|H|cause addiction. This risk may be higher if you have a||
5278|107|H|mental/mood disorder or a substance use disorder (such as overuse||
5278|108|H|of or addiction to drugs/alcohol). Take this medication exactly||
5278|109|H|as prescribed to lower the risk of addiction. Ask your doctor or||
5278|110|H|pharmacist for more details.||
5278|111|H|   Tell your doctor if your pain does not get better or if it||
5278|112|H|gets worse, or if you have any new pain.||
5278|113|B|||
5278|114|S|SIDE EFFECTS:  See also Warning section.||
5278|115|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
5278|116|S|drowsiness may occur. Some of these side effects may decrease||
5278|117|S|after you have been using this medication for a while. If any of||
5278|118|S|these effects last or get worse, tell your doctor or pharmacist||
5278|119|S|promptly.||
5278|120|S|   To prevent constipation, eat dietary fiber, drink enough||
5278|121|S|water, and exercise. You may also need to take a laxative. Ask||
5278|122|S|your pharmacist which type of laxative is right for you.||
5278|123|S|   To reduce the risk of dizziness and lightheadedness, get up||
5278|124|S|slowly when rising from a sitting or lying position.||
5278|125|S|   Remember that this medication has been prescribed because your||
5278|126|S|doctor has judged that the benefit to you is greater than the||
5278|127|S|risk of side effects. Many people using this medication do not||
5278|128|S|have serious side effects.||
5278|129|S|   Tell your doctor right away if you have any serious side||
5278|130|S|effects, including: interrupted breathing during sleep (sleep||
5278|131|S|apnea), mental/mood changes (such as agitation, confusion,||
5278|132|S|hallucinations), severe stomach/abdominal pain, difficulty||
5278|133|S|urinating, signs of your adrenal glands not working well (such as||
5278|134|S|loss of appetite, unusual tiredness, weight loss), trouble||
5278|135|S|swallowing.||
5278|136|S|   Get medical help right away if you have any very serious side||
5278|137|S|effects, including: fainting, seizure, slow/shallow breathing,||
5278|138|S|severe drowsiness/difficulty waking up.||
5278|139|S|   A very serious allergic reaction to this drug is rare.||
5278|140|S|However, get medical help right away if you notice any symptoms||
5278|141|S|of a serious allergic reaction, including: rash, itching/swelling||
5278|142|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5278|143|S|breathing.||
5278|144|S|   This is not a complete list of possible side effects. If you||
5278|145|S|notice other effects not listed above, contact your doctor or||
5278|146|S|pharmacist.||
5278|147|S|   In the US -||
5278|148|S|   Call your doctor for medical advice about side effects. You||
5278|149|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5278|150|S|www.fda.gov/medwatch.||
5278|151|S|   In Canada - Call your doctor for medical advice about side||
5278|152|S|effects. You may report side effects to Health Canada at||
5278|153|S|1-866-234-2345.||
5278|154|B|||
5278|155|P|PRECAUTIONS:  Before taking oxycodone, tell your doctor or||
5278|156|P|pharmacist if you are allergic to it; or to other opioid pain||
5278|157|P|relievers (such as oxymorphone); or if you have any other||
5278|158|P|allergies. This product may contain inactive ingredients, which||
5278|159|P|can cause allergic reactions or other problems. Talk to your||
5278|160|P|pharmacist for more details.||
5278|161|P|   Before using this medication, tell your doctor or pharmacist||
5278|162|P|your medical history, especially of: brain disorders (such as||
5278|163|P|head injury, tumor, seizures), breathing problems (such as||
5278|164|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
5278|165|P|kidney disease, liver disease, mental/mood disorders (such as||
5278|166|P|confusion, depression), personal or family history of a substance||
5278|167|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
5278|168|P|stomach/intestinal problems (such as blockage, constipation,||
5278|169|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
5278|170|P|(such as due to enlarged prostate), gallbladder disease, disease||
5278|171|P|of the pancreas (pancreatitis).||
5278|172|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5278|173|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5278|174|P|machinery, or do anything that needs alertness until you can do||
5278|175|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5278|176|P|are using marijuana (cannabis).||
5278|177|P|   Before having surgery, tell your doctor or dentist about all||
5278|178|P|the products you use (including prescription drugs,||
5278|179|P|nonprescription drugs, and herbal products).||
5278|180|P|   Liquid products may contain sugar, aspartame, and/or alcohol.||
5278|181|P|Caution is advised if you have diabetes, alcohol dependence,||
5278|182|P|liver disease, phenylketonuria (PKU), or any other condition that||
5278|183|P|requires you to limit/avoid these substances in your diet. Ask||
5278|184|P|your doctor or pharmacist about using this product safely.||
5278|185|P|   Older adults may be more sensitive to the side effects of this||
5278|186|P|drug, especially confusion, dizziness, drowsiness, and||
5278|187|P|slow/shallow breathing.||
5278|188|P|   During pregnancy, this medication should be used only when||
5278|189|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
5278|190|P|benefits with your doctor. (See also Warning section.)||
5278|191|P|   This drug passes into breast milk and may have undesirable||
5278|192|P|effects on a nursing infant. Tell the doctor right away if your||
5278|193|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
5278|194|P|breathing. Consult your doctor before breastfeeding.||
5278|195|B|||
5278|196|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
5278|197|I|   Drug interactions may change how your medications work or||
5278|198|I|increase your risk for serious side effects. This document does||
5278|199|I|not contain all possible drug interactions. Keep a list of all||
5278|200|I|the products you use (including prescription/nonprescription||
5278|201|I|drugs and herbal products) and share it with your doctor and||
5278|202|I|pharmacist. Do not start, stop, or change the dosage of any||
5278|203|I|medicines without your doctor's approval.||
5278|204|I|   Some products that may interact with this drug include:||
5278|205|I|certain pain medications (mixed opioid agonist/antagonists such||
5278|206|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
5278|207|I|samidorphan.||
5278|208|I|   The risk of serious side effects (such as slow/shallow||
5278|209|I|breathing, severe drowsiness/dizziness) may be increased if this||
5278|210|I|medication is taken with other products that may also cause||
5278|211|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5278|212|I|if you are taking other products such as other opioid pain or||
5278|213|I|cough relievers (such as codeine, hydrocodone), alcohol,||
5278|214|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
5278|215|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
5278|216|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
5278|217|I|cetirizine, diphenhydramine).||
5278|218|I|   Check the labels on all your medicines (such as allergy or||
5278|219|I|cough-and-cold products) because they may contain ingredients||
5278|220|I|that cause drowsiness. Ask your pharmacist about using those||
5278|221|I|products safely.||
5278|222|I|   Other medications can affect the removal of oxycodone from||
5278|223|I|your body, which may affect how oxycodone works. Examples include||
5278|224|I|azole antifungals (such as ketoconazole), macrolide antibiotics||
5278|225|I|(such as erythromycin), mifepristone, HIV medications (such as||
5278|226|I|tipranavir), rifamycins (such as rifabutin, rifampin), ritonavir,||
5278|227|I|certain drugs used to treat seizures (such as carbamazepine,||
5278|228|I|phenytoin), among others.||
5278|229|I|   This medication may interfere with certain lab tests (such as||
5278|230|I|amylase/lipase levels), possibly causing false test results. Make||
5278|231|I|sure lab personnel and all your doctors know you use this drug.||
5278|232|B|||
5278|233|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5278|234|O|as passing out or trouble breathing, give them naloxone or||
5278|235|O|nalmefene if available, then call 911. If the person is awake and||
5278|236|O|has no symptoms, call a poison control center right away. US||
5278|237|O|residents can call 1-800-222-1222. Canada residents can call||
5278|238|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
5278|239|O|breathing, slow heartbeat, coma.||
5278|240|B|||
5278|241|N|NOTES:  Do not share this medication with others. Sharing it is||
5278|242|N|against the law.||
5278|243|N|   This medication has been prescribed for your current condition||
5278|244|N|only. Do not use it later for another condition unless told to do||
5278|245|N|so by your doctor. A different medication may be necessary in||
5278|246|N|that case.||
5278|247|B|||
5278|248|D|MISSED DOSE:  If you are taking this medication on a regular||
5278|249|D|schedule and miss a dose, take it as soon as you remember. If it||
5278|250|D|is near the time of the next dose, skip the missed dose. Take||
5278|251|D|your next dose at the regular time. Do not double the dose to||
5278|252|D|catch up.||
5278|253|B|||
5278|254|R|STORAGE:  Store at room temperature away from light and moisture.||
5278|255|R|Do not store in the bathroom. Keep all medications away from||
5278|256|R|children and pets. See also Warning section.||
5278|257|R|   Do not flush medications down the toilet or pour them into a||
5278|258|R|drain unless instructed to do so. Properly discard this product||
5278|259|R|when it is expired or no longer needed. For more details, read||
5278|260|R|the Medication Guide, or consult your pharmacist or local waste||
5278|261|R|disposal company.||
5278|262|B|||
5278|263|A|Information last revised August 2025.||
5278|264|A|Copyright(c) 2025 First Databank, Inc.||
5278|265|B|||
5279|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5279|002|Z|does NOT have all possible information about this product. This||
5279|003|Z|information does not assure that this product is safe, effective,||
5279|004|Z|or appropriate for you. This information is not individual||
5279|005|Z|medical advice and does not substitute for the advice of your||
5279|006|Z|health care professional. Always ask your health care||
5279|007|Z|professional for complete information about this product and your||
5279|008|Z|specific health needs.||
5279|009|B|||
5279|010|T|PALIVIZUMAB - INJECTION||
5279|011|F|(PAL-i-VIZ-ue-mab)||
5279|012|B|||
5279|013|C|COMMON BRAND NAME(S): Synagis||
5279|014|B|||
5279|015|U|USES:  Palivizumab is used in certain infants and young children||
5279|016|U|to prevent serious lung infections (such as pneumonia) that are||
5279|017|U|caused by a certain virus (respiratory syncytial virus-RSV).||
5279|018|U|Palivizumab works by preventing the growth of the virus. This||
5279|019|U|medication is not used to treat RSV infection, but should be||
5279|020|U|continued even if your child gets the RSV infection to prevent a||
5279|021|U|more serious infection.||
5279|022|B|||
5279|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5279|024|H|from your health care professional before your child starts||
5279|025|H|receiving palivizumab and before each injection. If you have any||
5279|026|H|questions, ask your doctor or pharmacist.||
5279|027|H|   This medication is given into a muscle (usually the thigh) by||
5279|028|H|a health care professional as directed by your child's doctor,||
5279|029|H|usually once a month during RSV season. The dosage is based on||
5279|030|H|your child's weight.||
5279|031|H|   Your child should receive this medication regularly to get the||
5279|032|H|most benefit from it. To help you remember, mark your calendar||
5279|033|H|with a reminder.||
5279|034|B|||
5279|035|S|SIDE EFFECTS:  Fever or pain/redness/swelling at the injection||
5279|036|S|site may occur. If any of these effects last or get worse, tell||
5279|037|S|your doctor or pharmacist promptly.||
5279|038|S|   Remember that this medication has been prescribed because the||
5279|039|S|doctor has judged that the benefit to your child is greater than||
5279|040|S|the risk of side effects. Many people using this medication do||
5279|041|S|not have serious side effects.||
5279|042|S|   A very serious allergic reaction to this drug is rare.||
5279|043|S|However, get medical help right away if you notice any symptoms||
5279|044|S|of a serious allergic reaction, including: rash, itching/swelling||
5279|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5279|046|S|breathing.||
5279|047|S|   This is not a complete list of possible side effects. If you||
5279|048|S|notice other effects not listed above, contact your doctor or||
5279|049|S|pharmacist.||
5279|050|S|   In the US -||
5279|051|S|   Call your doctor for medical advice about side effects. You||
5279|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5279|053|S|www.fda.gov/medwatch.||
5279|054|S|   In Canada - Call your doctor for medical advice about side||
5279|055|S|effects. You may report side effects to Health Canada at||
5279|056|S|1-866-234-2345.||
5279|057|B|||
5279|058|P|PRECAUTIONS:  Before using palivizumab, tell the doctor or||
5279|059|P|pharmacist if your child is allergic to it; or if your child has||
5279|060|P|any other allergies. This product may contain inactive||
5279|061|P|ingredients, which can cause allergic reactions or other||
5279|062|P|problems. Talk to your pharmacist for more details.||
5279|063|P|   Before using this medication, tell the doctor or pharmacist||
5279|064|P|your child's medical history, especially of: bleeding/blood||
5279|065|P|clotting problems (such as low platelets, coagulation disorder).||
5279|066|P|   Before having surgery (especially certain heart procedures),||
5279|067|P|tell the doctor or dentist about this medication and all the||
5279|068|P|products your child uses (including prescription drugs,||
5279|069|P|nonprescription drugs, and herbal products).||
5279|070|P|   This medication is not usually used by adults. It is unlikely||
5279|071|P|to be used during pregnancy or breastfeeding. Consult your doctor||
5279|072|P|if you have any questions about this medication||
5279|073|B|||
5279|074|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5279|075|I|medications work or increase your risk for serious side effects.||
5279|076|I|This document does not contain all possible drug interactions.||
5279|077|I|Keep a list of all the products you use (including||
5279|078|I|prescription/nonprescription drugs and herbal products) and share||
5279|079|I|it with your doctor and pharmacist. Do not start, stop, or change||
5279|080|I|the dosage of any medicines without your doctor's approval.||
5279|081|I|   This medication may interfere with certain lab tests (such as||
5279|082|I|RSV diagnostic tests, virus culture tests), possibly causing||
5279|083|I|false test results. Make sure lab personnel and all your doctors||
5279|084|I|know you use this drug.||
5279|085|B|||
5279|086|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5279|087|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5279|088|O|poison control center right away. US residents can call||
5279|089|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5279|090|B|||
5279|091|N|NOTES:  Keep all medical and lab appointments.||
5279|092|B|||
5279|093|D|MISSED DOSE:  It is important to get each dose of this medication||
5279|094|D|as scheduled. If your child misses a dose, ask the doctor or||
5279|095|D|pharmacist right away for a new dosing schedule.||
5279|096|B|||
5279|097|R|STORAGE:  Not applicable. This medication is given in a clinic||
5279|098|R|and will not be stored at home.||
5279|099|B|||
5279|100|A|Information last revised June 2025.||
5279|101|A|Copyright(c) 2025 First Databank, Inc.||
5279|102|B|||
5281|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5281|002|Z|does NOT have all possible information about this product. This||
5281|003|Z|information does not assure that this product is safe, effective,||
5281|004|Z|or appropriate for you. This information is not individual||
5281|005|Z|medical advice and does not substitute for the advice of your||
5281|006|Z|health care professional. Always ask your health care||
5281|007|Z|professional for complete information about this product and your||
5281|008|Z|specific health needs.||
5281|009|B|||
5281|010|T|TRANDOLAPRIL/VERAPAMIL EXTENDED-RELEASE - ORAL||
5281|011|F|(tran-DOL-a-pril/ver-AP-a-mil)||
5281|012|B|||
5281|013|C|COMMON BRAND NAME(S): Tarka||
5281|014|B|||
5281|015|W|WARNING:  Trandolapril can cause serious (possibly fatal) harm to||
5281|016|W|an unborn baby if used during pregnancy. It is important to||
5281|017|W|prevent pregnancy while taking this product. Consult your doctor||
5281|018|W|for more details and to discuss the use of reliable forms of||
5281|019|W|birth control while taking this product. If you are planning||
5281|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
5281|021|W|your doctor right away.||
5281|022|B|||
5281|023|U|USES:  This product is used to treat high blood pressure.||
5281|024|U|Lowering high blood pressure helps prevent strokes, heart||
5281|025|U|attacks, and kidney problems. This product contains 2||
5281|026|U|medications: trandolapril and verapamil. Trandolapril belongs to||
5281|027|U|a class of drugs known as ACE inhibitors. Verapamil belongs to a||
5281|028|U|class of drugs known as calcium channel blockers. They both work||
5281|029|U|by relaxing blood vessels so blood can flow more easily.||
5281|030|U|Verapamil may also lower your heart rate.||
5281|031|B|||
5281|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5281|033|H|from your pharmacist before you start taking||
5281|034|H|trandolapril/verapamil and each time you get a refill. If you||
5281|035|H|have any questions, ask your doctor or pharmacist.||
5281|036|H|   Take this medication by mouth with food as directed your||
5281|037|H|doctor, usually once or twice daily. Swallow the tablets whole.||
5281|038|H|Do not crush or chew the tablets. Doing so can release all of the||
5281|039|H|drug at once, increasing the risk of side effects.||
5281|040|H|   The dosage is based on your medical condition and response to||
5281|041|H|treatment.||
5281|042|H|   Take this medication regularly to get the most benefit from||
5281|043|H|it. To help you remember, take it at the same time(s) each day.||
5281|044|H|Keep taking this medication even if you feel well. Most people||
5281|045|H|with high blood pressure do not feel sick.||
5281|046|H|   Do not stop taking this medication without consulting your||
5281|047|H|doctor. Some conditions may become worse when this drug is||
5281|048|H|suddenly stopped. Your dose may need to be gradually decreased.||
5281|049|H|   It may take up to several weeks before you get the full||
5281|050|H|benefit of this medication.||
5281|051|H|   Tell your doctor if your condition does not get better or if||
5281|052|H|it gets worse (your blood pressure readings remain high or||
5281|053|H|increase).||
5281|054|B|||
5281|055|S|SIDE EFFECTS:  Dizziness, lightheadedness, or tiredness may occur||
5281|056|S|as your body adjusts to the medication. Dry cough, constipation,||
5281|057|S|or nausea may also occur. If any of these effects last or get||
5281|058|S|worse, tell your doctor or pharmacist promptly.||
5281|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
5281|060|S|slowly when rising from a sitting or lying position.||
5281|061|S|   Remember that this medication has been prescribed because your||
5281|062|S|doctor has judged that the benefit to you is greater than the||
5281|063|S|risk of side effects. Many people using this medication do not||
5281|064|S|have serious side effects.||
5281|065|S|   Tell your doctor right away if you have any serious side||
5281|066|S|effects, including: fainting, new or worsening symptoms of heart||
5281|067|S|failure (such as shortness of breath, swelling ankles/feet,||
5281|068|S|unusual tiredness, unusual/sudden weight gain), symptoms of a||
5281|069|S|high potassium blood level (such as muscle weakness,||
5281|070|S|slow/irregular heartbeat), signs of kidney problems (such as||
5281|071|S|change in the amount of urine).||
5281|072|S|   This drug may rarely cause serious (possibly fatal) liver||
5281|073|S|problems. Get medical help right away if you have any symptoms of||
5281|074|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
5281|075|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
5281|076|S|urine.||
5281|077|S|   A very serious allergic reaction to this drug is rare.||
5281|078|S|However, get medical help right away if you notice any symptoms||
5281|079|S|of a serious allergic reaction, including: rash, itching/swelling||
5281|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5281|081|S|breathing.||
5281|082|S|   This is not a complete list of possible side effects. If you||
5281|083|S|notice other effects not listed above, contact your doctor or||
5281|084|S|pharmacist.||
5281|085|S|   In the US -||
5281|086|S|   Call your doctor for medical advice about side effects. You||
5281|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5281|088|S|www.fda.gov/medwatch.||
5281|089|S|   In Canada - Call your doctor for medical advice about side||
5281|090|S|effects. You may report side effects to Health Canada at||
5281|091|S|1-866-234-2345.||
5281|092|B|||
5281|093|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
5281|094|P|pharmacist if you are allergic to trandolapril or verapamil; or||
5281|095|P|to other ACE inhibitors (such as benazepril, lisinopril); or if||
5281|096|P|you have any other allergies. This product may contain inactive||
5281|097|P|ingredients, which can cause allergic reactions or other||
5281|098|P|problems. Talk to your pharmacist for more details.||
5281|099|P|   Before using this medication, tell your doctor or pharmacist||
5281|100|P|your medical history, especially of: certain types of heart||
5281|101|P|rhythm problems (such as second- or third-degree atrioventricular||
5281|102|P|block, sick sinus syndrome unless you have a pacemaker,||
5281|103|P|Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome),||
5281|104|P|certain types of heart problems (such as aortic stenosis, heart||
5281|105|P|failure), certain muscle/nerve disorders (muscular dystrophy,||
5281|106|P|myasthenia gravis), history of an allergic reaction which||
5281|107|P|included swelling of the face/lips/tongue/throat (angioedema),||
5281|108|P|blood filtering procedures (such as LDL apheresis, dialysis),||
5281|109|P|liver disease, kidney disease, high level of potassium in the||
5281|110|P|blood.||
5281|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5281|112|P|can make you more dizzy. Do not drive, use machinery, or do||
5281|113|P|anything that needs alertness until you can do it safely. Limit||
5281|114|P|alcoholic beverages. Talk to your doctor if you are using||
5281|115|P|marijuana (cannabis).||
5281|116|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
5281|117|P|and cause you to feel lightheaded. Tell your doctor if you have||
5281|118|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
5281|119|P|of fluids unless your doctor tells you not to.||
5281|120|P|   This product may increase your potassium levels. Before using||
5281|121|P|potassium supplements or salt substitutes that contain potassium,||
5281|122|P|consult your doctor or pharmacist.||
5281|123|P|   Before having surgery, tell your doctor or dentist about all||
5281|124|P|the products you use (including prescription drugs,||
5281|125|P|nonprescription drugs, and herbal products).||
5281|126|P|   Older adults may be more sensitive to the side effects of this||
5281|127|P|drug, especially dizziness, increases in potassium level,||
5281|128|P|constipation, swelling ankles/feet, and change in the amount of||
5281|129|P|urine (kidney problems).||
5281|130|P|   Tell your doctor if you are pregnant or plan to become||
5281|131|P|pregnant. You should not become pregnant while using||
5281|132|P|trandolapril/verapamil. Trandolapril may harm an unborn baby. If||
5281|133|P|you become pregnant, talk to your doctor right away about the||
5281|134|P|risks and benefits of this medication. See also Warning section.||
5281|135|P|   Verapamil passes into breast milk. It is unknown if||
5281|136|P|trandolapril passes into breast milk. Consult your doctor before||
5281|137|P|breastfeeding.||
5281|138|B|||
5281|139|I|DRUG INTERACTIONS:  See also Precautions section.||
5281|140|I|   Drug interactions may change how your medications work or||
5281|141|I|increase your risk for serious side effects. This document does||
5281|142|I|not contain all possible drug interactions. Keep a list of all||
5281|143|I|the products you use (including prescription/nonprescription||
5281|144|I|drugs and herbal products) and share it with your doctor and||
5281|145|I|pharmacist. Do not start, stop, or change the dosage of any||
5281|146|I|medicines without your doctor's approval.||
5281|147|I|   Some products that may interact with this drug include:||
5281|148|I|aliskiren, clonidine, disopyramide, dofetilide, fingolimod, gold||
5281|149|I|injections, labetalol, lithium, sacubitril, certain drugs that||
5281|150|I|weaken the immune system/increase the risk of infection (such as||
5281|151|I|everolimus, sirolimus), drugs that may increase the level of||
5281|152|I|potassium in the blood (such as ARBs including||
5281|153|I|losartan/valsartan, birth control pills containing drospirenone).||
5281|154|I|   Other medications can affect the removal of verapamil from||
5281|155|I|your body, which may affect how this product works. Examples||
5281|156|I|include erythromycin, rifamycins (such as rifampin), ritonavir,||
5281|157|I|St. John's wort, among others.||
5281|158|I|   Verapamil can slow down the removal of other medications from||
5281|159|I|your body, which may affect how they work. Examples of affected||
5281|160|I|drugs include colchicine, elacestrant, fezolinetant, flibanserin,||
5281|161|I|ivabradine, lomitapide, midazolam, rilzabrutinib, taletrectinib,||
5281|162|I|triazolam, among others.||
5281|163|I|   Some products have ingredients that could raise your heart||
5281|164|I|rate or blood pressure. Tell your pharmacist what products you||
5281|165|I|are using, and ask how to use them safely (especially||
5281|166|I|cough-and-cold products, diet aids, or NSAIDs such as||
5281|167|I|ibuprofen/naproxen).||
5281|168|I|   A very serious reaction may occur if you are getting||
5281|169|I|injections for bee/wasp sting allergy (desensitization) and are||
5281|170|I|also taking trandolapril/verapamil. Make sure all your doctors||
5281|171|I|know which medicines you are using.||
5281|172|B|||
5281|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5281|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5281|175|O|poison control center right away. US residents can call||
5281|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5281|177|O|Symptoms of overdose may include: severe dizziness, fainting,||
5281|178|O|very slow heartbeat.||
5281|179|B|||
5281|180|N|NOTES:  Do not share this medication with others.||
5281|181|N|   Lifestyle changes that may help this medication work better||
5281|182|N|include exercising, stopping smoking, and eating a||
5281|183|N|low-cholesterol/low-fat diet. Consult your doctor for more||
5281|184|N|details.||
5281|185|N|   Lab and/or medical tests (such as kidney function, potassium||
5281|186|N|levels, liver function) should be done while you are taking this||
5281|187|N|medication. Keep all medical and lab appointments. Consult your||
5281|188|N|doctor for more details.||
5281|189|N|   Check your blood pressure and pulse (heart rate) regularly||
5281|190|N|while taking this medication. Learn how to check your own blood||
5281|191|N|pressure and pulse at home, and share the results with your||
5281|192|N|doctor.||
5281|193|B|||
5281|194|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5281|195|D|remember. If it is near the time of the next dose, skip the||
5281|196|D|missed dose. Take your next dose at the regular time. Do not||
5281|197|D|double the dose to catch up.||
5281|198|B|||
5281|199|R|STORAGE:  Store at room temperature away from light and moisture.||
5281|200|R|Do not store in the bathroom. Keep all medications away from||
5281|201|R|children and pets.||
5281|202|R|   Do not flush medications down the toilet or pour them into a||
5281|203|R|drain unless instructed to do so. Properly discard this product||
5281|204|R|when it is expired or no longer needed. Consult your pharmacist||
5281|205|R|or local waste disposal company.||
5281|206|B|||
5281|207|A|Information last revised September 2025.||
5281|208|A|Copyright(c) 2025 First Databank, Inc.||
5281|209|B|||
5282|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5282|002|Z|does NOT have all possible information about this product. This||
5282|003|Z|information does not assure that this product is safe, effective,||
5282|004|Z|or appropriate for you. This information is not individual||
5282|005|Z|medical advice and does not substitute for the advice of your||
5282|006|Z|health care professional. Always ask your health care||
5282|007|Z|professional for complete information about this product and your||
5282|008|Z|specific health needs.||
5282|009|B|||
5282|010|T|DIPHENHYDRAMINE - ORAL||
5282|011|F|(DYE-fen-HYE-dra-meen)||
5282|012|B|||
5282|013|C|COMMON BRAND NAME(S): Benadryl, Genahist, Naramin, Sominex, Unisom||
5282|014|B|||
5282|015|U|USES:  Diphenhydramine is an antihistamine used to relieve||
5282|016|U|symptoms of allergy, hay fever, and the common cold. These||
5282|017|U|symptoms include rash, itching, watery eyes, itchy||
5282|018|U|eyes/nose/throat, cough, runny nose, and sneezing. It is also||
5282|019|U|used to prevent and treat nausea, vomiting and dizziness caused||
5282|020|U|by motion sickness. Diphenhydramine can also be used to help you||
5282|021|U|relax and fall asleep.||
5282|022|U|   This medication works by blocking a certain natural substance||
5282|023|U|(histamine) that your body makes during an allergic reaction. Its||
5282|024|U|drying effects on such symptoms as watery eyes and runny nose are||
5282|025|U|caused by blocking another natural substance made by your body||
5282|026|U|(acetylcholine).||
5282|027|U|   Cough-and-cold products have not been shown to be safe or||
5282|028|U|effective in children younger than 6 years. Do not use this||
5282|029|U|product to treat cold symptoms in children younger than 6 years||
5282|030|U|unless specifically directed by the doctor. Some products (such||
5282|031|U|as long-acting tablets/capsules) are not recommended for use in||
5282|032|U|children younger than 12 years. Ask your doctor or pharmacist for||
5282|033|U|more details about using your product safely.||
5282|034|U|   These products do not cure or shorten the length of the common||
5282|035|U|cold and may cause serious side effects. To decrease the risk for||
5282|036|U|serious side effects, carefully follow all dosage directions. Do||
5282|037|U|not use this product to make a child sleepy. Do not give other||
5282|038|U|cough-and-cold medication that might contain the same or similar||
5282|039|U|ingredients (see also Drug Interactions section). Ask the doctor||
5282|040|U|or pharmacist about other ways to relieve cough and cold symptoms||
5282|041|U|(such as drinking enough fluids, using a humidifier or saline||
5282|042|U|nose drops/spray).||
5282|043|B|||
5282|044|V|OTHER USES:  This section contains uses of this drug that are not||
5282|045|V|listed in the approved professional labeling for the drug but||
5282|046|V|that may be prescribed by your health care professional. Use this||
5282|047|V|drug for a condition that is listed in this section only if it||
5282|048|V|has been so prescribed by your health care professional.||
5282|049|V|   This drug may also be used for shaking (tremor) and muscle||
5282|050|V|stiffness caused by Parkinson's disease. It may also be used for||
5282|051|V|side effects of certain psychiatric drugs such as involuntary||
5282|052|V|movements and muscle stiffness (such as EPS). It works by||
5282|053|V|blocking acetylcholine (see also Uses section).||
5282|054|B|||
5282|055|H|HOW TO USE:  Follow all directions on the product package. If||
5282|056|H|your doctor has prescribed this medication, take it as directed.||
5282|057|H|If you have any questions, ask your doctor or pharmacist.||
5282|058|H|   Take the tablet, capsule, or liquid form by mouth with or||
5282|059|H|without food. Measure liquid forms of this medication using a||
5282|060|H|special measuring device/spoon. Do not use a household spoon||
5282|061|H|because you may not get the correct dose. If you have a||
5282|062|H|single-dose form of this medication (such as a single-use||
5282|063|H|whistle), you do not need to measure the dose.||
5282|064|H|   The rapidly-dissolving tablet or strip should be allowed to||
5282|065|H|dissolve on the tongue and then swallowed, with or without water.||
5282|066|H|The chewable tablets should be chewed thoroughly before being||
5282|067|H|swallowed.||
5282|068|H|   The dosage is based on your age, medical condition, and||
5282|069|H|response to treatment. There are many brands and forms of||
5282|070|H|diphenhydramine available. Read the dosing instructions carefully||
5282|071|H|for each product because the amount of diphenhydramine may be||
5282|072|H|different between products. Do not increase your dose or take||
5282|073|H|this medication more often than directed.||
5282|074|H|   To prevent motion sickness, take your dose 30 minutes before||
5282|075|H|starting activity such as travel. To help you sleep, take your||
5282|076|H|dose about 30 minutes before bedtime. If you continue to have||
5282|077|H|difficulty sleeping for longer than 2 weeks, contact your doctor.||
5282|078|H|   Tell your doctor if your condition does not get better or if||
5282|079|H|it gets worse.||
5282|080|B|||
5282|081|S|SIDE EFFECTS:  Drowsiness, dizziness, constipation, stomach||
5282|082|S|upset, blurred vision, or dry mouth/nose/throat may occur. If any||
5282|083|S|of these effects last or get worse, tell your doctor or||
5282|084|S|pharmacist promptly.||
5282|085|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
5282|086|S|chips, chew (sugarless) gum, drink water, or use a saliva||
5282|087|S|substitute.||
5282|088|S|   If your doctor has directed you to use this medication,||
5282|089|S|remember that your doctor has judged that the benefit to you is||
5282|090|S|greater than the risk of side effects. Many people using this||
5282|091|S|medication do not have serious side effects.||
5282|092|S|   Tell your doctor right away if you have any serious side||
5282|093|S|effects, including: mental/mood changes (such as restlessness,||
5282|094|S|confusion), difficulty urinating, fast/irregular heartbeat.||
5282|095|S|   Get medical help right away if you have any very serious side||
5282|096|S|effects, including: seizures.||
5282|097|S|   A very serious allergic reaction to this drug is rare.||
5282|098|S|However, get medical help right away if you notice any symptoms||
5282|099|S|of a serious allergic reaction, including: rash, itching/swelling||
5282|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5282|101|S|breathing.||
5282|102|S|   This is not a complete list of possible side effects. If you||
5282|103|S|notice other effects not listed above, contact your doctor or||
5282|104|S|pharmacist.||
5282|105|S|   In the US -||
5282|106|S|   Call your doctor for medical advice about side effects. You||
5282|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5282|108|S|www.fda.gov/medwatch.||
5282|109|S|   In Canada - Call your doctor for medical advice about side||
5282|110|S|effects. You may report side effects to Health Canada at||
5282|111|S|1-866-234-2345.||
5282|112|B|||
5282|113|P|PRECAUTIONS:  Before taking diphenhydramine, tell your doctor or||
5282|114|P|pharmacist if you are allergic to it; or to dimenhydrinate; or if||
5282|115|P|you have any other allergies. This product may contain inactive||
5282|116|P|ingredients, which can cause allergic reactions or other||
5282|117|P|problems. Talk to your pharmacist for more details.||
5282|118|P|   Before using this medication, tell your doctor or pharmacist||
5282|119|P|your medical history, especially of: breathing problems (such as||
5282|120|P|asthma, emphysema), high pressure in the eye (glaucoma), heart||
5282|121|P|problems, high blood pressure, liver disease, seizures,||
5282|122|P|stomach/intestine problems (such as ulcers, blockage), overactive||
5282|123|P|thyroid (hyperthyroidism), difficulty urinating (for example, due||
5282|124|P|to enlarged prostate).||
5282|125|P|   This drug may make you dizzy or drowsy or blur your vision.||
5282|126|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
5282|127|P|drowsy. Do not drive, use machinery, or do anything that needs||
5282|128|P|alertness or clear vision until you can do it safely. Avoid||
5282|129|P|alcoholic beverages. Talk to your doctor if you are using||
5282|130|P|marijuana (cannabis).||
5282|131|P|   Before having surgery, tell your doctor or dentist about all||
5282|132|P|the products you use (including prescription drugs,||
5282|133|P|nonprescription drugs, and herbal products).||
5282|134|P|   Liquid products, chewable tablets, or dissolving||
5282|135|P|tablets/strips may contain sugar and/or aspartame. Liquid||
5282|136|P|products may also contain alcohol. Caution is advised if you have||
5282|137|P|diabetes, liver disease, phenylketonuria (PKU), or any other||
5282|138|P|condition that requires you to limit/avoid these substances in||
5282|139|P|your diet. Ask your doctor or pharmacist about using this product||
5282|140|P|safely.||
5282|141|P|   Children may be more sensitive to the side effects of this||
5282|142|P|drug. This drug can often cause excitement in young children||
5282|143|P|instead of drowsiness.||
5282|144|P|   Older adults may be more sensitive to the side effects of this||
5282|145|P|drug, especially drowsiness, dizziness, confusion, constipation,||
5282|146|P|or trouble urinating. Drowsiness, dizziness, and confusion can||
5282|147|P|increase the risk of falling.||
5282|148|P|   During pregnancy, this medication should be used only when||
5282|149|P|clearly needed. Discuss the risks and benefits with your doctor.||
5282|150|P|   This drug passes into breast milk and may have undesirable||
5282|151|P|effects on a nursing infant. Consult your doctor before||
5282|152|P|breastfeeding.||
5282|153|B|||
5282|154|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5282|155|I|medications work or increase your risk for serious side effects.||
5282|156|I|This document does not contain all possible drug interactions.||
5282|157|I|Keep a list of all the products you use (including||
5282|158|I|prescription/nonprescription drugs and herbal products) and share||
5282|159|I|it with your doctor and pharmacist. Do not start, stop, or change||
5282|160|I|the dosage of any medicines without your doctor's approval.||
5282|161|I|   Some products that may interact with this drug include:||
5282|162|I|antihistamines applied to the skin (such as diphenhydramine||
5282|163|I|cream, ointment, spray).||
5282|164|I|   Tell your doctor or pharmacist if you are taking other||
5282|165|I|products that cause drowsiness such as opioid pain or cough||
5282|166|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5282|167|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5282|168|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5282|169|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
5282|170|I|chlorpheniramine).||
5282|171|I|   Check the labels on all your medicines (such as allergy or||
5282|172|I|cough-and-cold products) because they may contain ingredients||
5282|173|I|that cause drowsiness. Ask your pharmacist about using those||
5282|174|I|products safely.||
5282|175|I|   This medication may interfere with certain lab tests (such as||
5282|176|I|allergy skin test), possibly causing false test results. Make||
5282|177|I|sure lab personnel and all your doctors know you use this drug.||
5282|178|B|||
5282|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5282|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5282|181|O|poison control center right away. US residents can call||
5282|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5282|183|O|Symptoms of overdose may include: severe drowsiness, seizures,||
5282|184|O|widened pupils. In children, mental/mood changes (such as||
5282|185|O|restlessness, irritability, hallucinations) may occur before||
5282|186|O|drowsiness.||
5282|187|B|||
5282|188|N|NOTES:  Keep all medical and lab appointments.||
5282|189|B|||
5282|190|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5282|191|D|remember. If it is near the time of your next dose, skip the||
5282|192|D|missed dose. Take your next dose at the regular time. Do not||
5282|193|D|double the dose to catch up.||
5282|194|B|||
5282|195|R|STORAGE:  Store at room temperature away from moisture and light.||
5282|196|R|Do not store in the bathroom. Do not freeze liquid forms of this||
5282|197|R|medication. Keep all medications away from children and pets.||
5282|198|R|   Do not flush medications down the toilet or pour them into a||
5282|199|R|drain unless instructed to do so. Properly discard this product||
5282|200|R|when it is expired or no longer needed. Consult your pharmacist||
5282|201|R|or local waste disposal company.||
5282|202|B|||
5282|203|A|Information last revised October 2024.||
5282|204|A|Copyright(c) 2025 First Databank, Inc.||
5282|205|B|||
5284|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5284|002|Z|does NOT have all possible information about this product. This||
5284|003|Z|information does not assure that this product is safe, effective,||
5284|004|Z|or appropriate for you. This information is not individual||
5284|005|Z|medical advice and does not substitute for the advice of your||
5284|006|Z|health care professional. Always ask your health care||
5284|007|Z|professional for complete information about this product and your||
5284|008|Z|specific health needs.||
5284|009|B|||
5284|010|T|EZETIMIBE - ORAL||
5284|011|F|(eh-ZET-ih-mibe)||
5284|012|B|||
5284|013|C|COMMON BRAND NAME(S): Zetia||
5284|014|B|||
5284|015|U|USES:  Ezetimibe is used along with a low cholesterol/low fat||
5284|016|U|diet and exercise to help lower cholesterol in the blood.||
5284|017|U|Ezetimibe may be used alone or with other drugs (such as||
5284|018|U|"statins" or fibrates). Ezetimibe works by reducing the amount of||
5284|019|U|cholesterol your body absorbs from your diet. Reducing||
5284|020|U|cholesterol may help prevent strokes and heart attacks.||
5284|021|B|||
5284|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5284|023|H|from your pharmacist before you start taking ezetimibe and each||
5284|024|H|time you get a refill. If you have any questions, ask your doctor||
5284|025|H|or pharmacist.||
5284|026|H|   Take this medication by mouth as directed by your doctor,||
5284|027|H|usually once daily with or without food.||
5284|028|H|   The dosage is based on your medical condition and response to||
5284|029|H|treatment.||
5284|030|H|   If taking a bile acid sequestrant (such as cholestyramine,||
5284|031|H|colestipol), take ezetimibe at least 2 hours before or 4 hours||
5284|032|H|after taking the bile acid sequestrant. These products may bind||
5284|033|H|to ezetimibe, preventing your body from fully absorbing the drug.||
5284|034|H|   Take this medication regularly to get the most benefit from||
5284|035|H|it. To help you remember, take it at the same time each day.||
5284|036|H|   Keep taking this medication even if you feel well. Most people||
5284|037|H|with high cholesterol do not feel sick. It may take up to 2 weeks||
5284|038|H|before you get the full benefit of this drug.||
5284|039|B|||
5284|040|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
5284|041|S|because your doctor has judged that the benefit to you is greater||
5284|042|S|than the risk of side effects. Many people using this medication||
5284|043|S|do not have serious side effects.||
5284|044|S|   This drug may increase the risk of liver damage (when taken||
5284|045|S|with a "statin") or muscle damage when taken with a fibrate or||
5284|046|S|"statin". Tell your doctor right away if you experience any of||
5284|047|S|the following symptoms: signs of liver problems (such as||
5284|048|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain,||
5284|049|S|yellowing eyes/skin, dark urine), muscle pain/tenderness/weakness||
5284|050|S|(especially with fever or unusual tiredness).||
5284|051|S|   A very serious allergic reaction to this drug is rare.||
5284|052|S|However, get medical help right away if you notice any symptoms||
5284|053|S|of a serious allergic reaction, including: rash, itching/swelling||
5284|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5284|055|S|breathing.||
5284|056|S|   This is not a complete list of possible side effects. If you||
5284|057|S|notice other effects not listed above, contact your doctor or||
5284|058|S|pharmacist.||
5284|059|S|   In the US -||
5284|060|S|   Call your doctor for medical advice about side effects. You||
5284|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5284|062|S|www.fda.gov/medwatch.||
5284|063|S|   In Canada - Call your doctor for medical advice about side||
5284|064|S|effects. You may report side effects to Health Canada at||
5284|065|S|1-866-234-2345.||
5284|066|B|||
5284|067|P|PRECAUTIONS:  Before taking ezetimibe, tell your doctor or||
5284|068|P|pharmacist if you are allergic to it; or if you have any other||
5284|069|P|allergies. This product may contain inactive ingredients, which||
5284|070|P|can cause allergic reactions or other problems. Talk to your||
5284|071|P|pharmacist for more details.||
5284|072|P|   Before using this medication, tell your doctor or pharmacist||
5284|073|P|your medical history, especially of: liver disease.||
5284|074|P|   Before having surgery, tell your doctor or dentist about all||
5284|075|P|the products you use (including prescription drugs,||
5284|076|P|nonprescription drugs, and herbal products).||
5284|077|P|   During pregnancy, this medication should be used only when||
5284|078|P|clearly needed. Discuss the risks and benefits with your doctor.||
5284|079|P|   This drug passes into breast milk. Consult your doctor before||
5284|080|P|breastfeeding.||
5284|081|B|||
5284|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5284|083|I|medications work or increase your risk for serious side effects.||
5284|084|I|This document does not contain all possible drug interactions.||
5284|085|I|Keep a list of all the products you use (including||
5284|086|I|prescription/nonprescription drugs and herbal products) and share||
5284|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
5284|088|I|the dosage of any medicines without your doctor's approval.||
5284|089|B|||
5284|090|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5284|091|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5284|092|O|poison control center right away. US residents can call||
5284|093|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5284|094|B|||
5284|095|N|NOTES:  Do not share this medication with others.||
5284|096|N|   Lab and/or medical tests (such as cholesterol levels, liver||
5284|097|N|function) should be done while you are taking this medication.||
5284|098|N|Keep all medical and lab appointments. Consult your doctor for||
5284|099|N|more details.||
5284|100|B|||
5284|101|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5284|102|D|If it is near the time of the next dose, skip the missed dose.||
5284|103|D|Use your next dose at the regular time. Do not double the dose to||
5284|104|D|catch up.||
5284|105|B|||
5284|106|R|STORAGE:  Store at room temperature away from light and moisture.||
5284|107|R|Do not store in the bathroom. Keep all medications away from||
5284|108|R|children and pets.||
5284|109|R|   Do not flush medications down the toilet or pour them into a||
5284|110|R|drain unless instructed to do so. Properly discard this product||
5284|111|R|when it is expired or no longer needed. Consult your pharmacist||
5284|112|R|or local waste disposal company.||
5284|113|B|||
5284|114|A|Information last revised July 2025.||
5284|115|A|Copyright(c) 2025 First Databank, Inc.||
5284|116|B|||
5287|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5287|002|Z|does NOT have all possible information about this product. This||
5287|003|Z|information does not assure that this product is safe, effective,||
5287|004|Z|or appropriate for you. This information is not individual||
5287|005|Z|medical advice and does not substitute for the advice of your||
5287|006|Z|health care professional. Always ask your health care||
5287|007|Z|professional for complete information about this product and your||
5287|008|Z|specific health needs.||
5287|009|B|||
5287|010|T|THIORIDAZINE - ORAL||
5287|011|F|(thigh-oh-RID-uh-zeen)||
5287|012|B|||
5287|013|C|COMMON BRAND NAME(S): Mellaril||
5287|014|B|||
5287|015|W|WARNING:  Thioridazine rarely has caused very serious (possibly||
5287|016|W|fatal) irregular heartbeat (QT prolongation in the EKG). It||
5287|017|W|should be used only in patients who have not shown improvement||
5287|018|W|with at least 2 other antipsychotic medications or who cannot||
5287|019|W|tolerate other antipsychotic medications. This medication should||
5287|020|W|not be used with other medications that can also cause a slow or||
5287|021|W|irregular heartbeat. (See also Drug Interactions.)||
5287|022|W|   There may be a slightly increased risk of serious, possibly||
5287|023|W|fatal side effects (such as heart failure, fast/irregular||
5287|024|W|heartbeat, pneumonia) when this medication is used by older||
5287|025|W|adults with dementia. This medication is not approved for the||
5287|026|W|treatment of dementia-related behavior problems. Discuss the||
5287|027|W|risks and benefits of this medication, as well as other effective||
5287|028|W|and possibly safer treatments for dementia-related behavior||
5287|029|W|problems, with the doctor.||
5287|030|B|||
5287|031|U|USES:  This medication is used to treat certain mental/mood||
5287|032|U|disorders (such as schizophrenia). Thioridazine belongs to a||
5287|033|U|class of drugs known as antipsychotics. It works by helping to||
5287|034|U|restore the balance of certain natural substances in the brain.||
5287|035|B|||
5287|036|V|OTHER USES:  This section contains uses of this drug that are not||
5287|037|V|listed in the approved professional labeling for the drug but||
5287|038|V|that may be prescribed by your health care professional. Use this||
5287|039|V|drug for a condition that is listed in this section only if it||
5287|040|V|has been so prescribed by your health care professional.||
5287|041|V|   This drug may also be used for short periods of time for very||
5287|042|V|severe depression when the patient is also anxious.||
5287|043|B|||
5287|044|H|HOW TO USE:  Take this medication by mouth with or without food||
5287|045|H|as directed by your doctor, usually 2 to 4 times a day. The||
5287|046|H|dosage is based on your medical condition and response to||
5287|047|H|treatment.||
5287|048|H|   Once your condition improves and you are better for a while,||
5287|049|H|your doctor may work with you to reduce your regular dose. This||
5287|050|H|may be done over time. Do not stop your medication or lower your||
5287|051|H|dose without talking with your doctor first. Some conditions may||
5287|052|H|become worse when the drug is stopped abruptly. Your dose may||
5287|053|H|need to be gradually reduced.||
5287|054|H|   Use this medication regularly in order to get the most benefit||
5287|055|H|from it. To help you remember, use it at the same times each day.||
5287|056|H|   Tell your doctor if your condition lasts or gets worse.||
5287|057|B|||
5287|058|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, difficulty||
5287|059|S|urinating, constipation, restlessness, headache, and blurred||
5287|060|S|vision may occur. If any of these effects last or get worse, tell||
5287|061|S|your doctor or pharmacist promptly.||
5287|062|S|   Dizziness and lightheadedness can increase the risk of||
5287|063|S|falling. Get up slowly when rising from a sitting or lying||
5287|064|S|position.||
5287|065|S|   Remember that this medication has been prescribed because your||
5287|066|S|doctor has judged that the benefit to you is greater than the||
5287|067|S|risk of side effects. Many people using this medication do not||
5287|068|S|have serious side effects.||
5287|069|S|   Tell your doctor right away if you have any serious side||
5287|070|S|effects, including: shaking (tremors), mask-like facial||
5287|071|S|expression, shuffling walk, muscle spasms, signs of infection||
5287|072|S|(such as sore throat that doesn't go away, fever, chills), vision||
5287|073|S|changes (such as vision loss, sudden difficulty seeing at night,||
5287|074|S|brown-tinged vision).||
5287|075|S|   Get medical help right away if you have any very serious side||
5287|076|S|effects, including: severe dizziness, fainting, slow heartbeat,||
5287|077|S|seizures.||
5287|078|S|   Thioridazine may rarely cause a condition known as tardive||
5287|079|S|dyskinesia. In some cases this condition may be permanent. Tell||
5287|080|S|your doctor right away if you develop any unusual/uncontrolled||
5287|081|S|movements (especially of the face, lips, tongue, arms or legs).||
5287|082|S|   In rare cases, thioridazine may increase your level of a||
5287|083|S|certain chemical made by the body (prolactin). For females, this||
5287|084|S|increase in prolactin may result in unwanted breast milk,||
5287|085|S|missed/stopped periods, or difficulty becoming pregnant. For||
5287|086|S|males, it may result in decreased sexual ability, inability to||
5287|087|S|produce sperm, or enlarged breasts. If you develop any of these||
5287|088|S|symptoms, tell your doctor right away.||
5287|089|S|   This medication may rarely cause a very serious condition||
5287|090|S|called neuroleptic malignant syndrome (NMS). Get medical help||
5287|091|S|right away if you have any of the following symptoms: fever,||
5287|092|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
5287|093|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
5287|094|S|signs of kidney problems (such as change in the amount of urine).||
5287|095|S|   A very serious allergic reaction to this drug is rare.||
5287|096|S|However, get medical help right away if you notice any symptoms||
5287|097|S|of a serious allergic reaction, including: rash, itching/swelling||
5287|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5287|099|S|breathing.||
5287|100|S|   This is not a complete list of possible side effects. If you||
5287|101|S|notice other effects not listed above, contact your doctor or||
5287|102|S|pharmacist.||
5287|103|S|   In the US -||
5287|104|S|   Call your doctor for medical advice about side effects. You||
5287|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5287|106|S|www.fda.gov/medwatch.||
5287|107|S|   In Canada - Call your doctor for medical advice about side||
5287|108|S|effects. You may report side effects to Health Canada at||
5287|109|S|1-866-234-2345.||
5287|110|B|||
5287|111|P|PRECAUTIONS:  Before taking thioridazine, tell your doctor or||
5287|112|P|pharmacist if you are allergic to it; or to other phenothiazines||
5287|113|P|(such as chlorpromazine); or if you have any other allergies.||
5287|114|P|This product may contain inactive ingredients, which can cause||
5287|115|P|allergic reactions or other problems. Talk to your pharmacist for||
5287|116|P|more details.||
5287|117|P|   Before using this medication, tell your doctor or pharmacist||
5287|118|P|your medical history, especially of: nervous system problems||
5287|119|P|(such as seizures, drug/alcohol overdose, severe drowsiness),||
5287|120|P|blood pressure problems, certain blood problems (such as low||
5287|121|P|white blood cell count), Parkinson's disease, low enzymes needed||
5287|122|P|to remove drugs from the body (slow hydroxylator).||
5287|123|P|   Thioridazine may cause a condition that affects the heart||
5287|124|P|rhythm (QT prolongation). QT prolongation can rarely cause||
5287|125|P|serious (rarely fatal) fast/irregular heartbeat and other||
5287|126|P|symptoms (such as severe dizziness, fainting) that need medical||
5287|127|P|attention right away.||
5287|128|P|   The risk of QT prolongation may be increased if you have||
5287|129|P|certain medical conditions or are taking other drugs that may||
5287|130|P|cause QT prolongation. Before using thioridazine, tell your||
5287|131|P|doctor or pharmacist of all the drugs you take and if you have||
5287|132|P|any of the following conditions: certain heart problems (heart||
5287|133|P|failure, slow heartbeat, QT prolongation in the EKG), family||
5287|134|P|history of certain heart problems (QT prolongation in the EKG,||
5287|135|P|sudden cardiac death).||
5287|136|P|   Low levels of potassium or magnesium in the blood may also||
5287|137|P|increase your risk of QT prolongation. This risk may increase if||
5287|138|P|you use certain drugs (such as diuretics/"water pills") or if you||
5287|139|P|have conditions such as severe sweating, diarrhea, or vomiting.||
5287|140|P|Talk to your doctor about using thioridazine safely.||
5287|141|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5287|142|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5287|143|P|machinery, or do anything that needs alertness until you can do||
5287|144|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
5287|145|P|are using marijuana (cannabis).||
5287|146|P|   Before having surgery, tell your doctor or dentist about all||
5287|147|P|the products you use (including prescription drugs,||
5287|148|P|nonprescription drugs, and herbal products).||
5287|149|P|   This medication may make you more sensitive to the sun. Limit||
5287|150|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
5287|151|P|sunscreen and wear protective clothing when outdoors. Tell your||
5287|152|P|doctor right away if you get sunburned or have skin||
5287|153|P|blisters/redness.||
5287|154|P|   Older adults may be more sensitive to the side effects of this||
5287|155|P|drug, especially dizziness, lightheadedness, drowsiness,||
5287|156|P|confusion, constipation, difficulty urinating, and QT||
5287|157|P|prolongation (see above). Dizziness, lightheadedness, drowsiness,||
5287|158|P|and confusion can increase the risk of falling.||
5287|159|P|   During pregnancy, this medication should be used only when||
5287|160|P|clearly needed. Babies born to mothers who have used this drug||
5287|161|P|during the last 3 months of pregnancy may rarely develop symptoms||
5287|162|P|including muscle stiffness or shakiness, drowsiness,||
5287|163|P|feeding/breathing difficulties, or constant crying. If you notice||
5287|164|P|any of these symptoms in your newborn especially during their||
5287|165|P|first month, tell the doctor right away.||
5287|166|P|   Since untreated mental/mood problems (such as schizophrenia,||
5287|167|P|depression) can be a serious condition, do not stop taking this||
5287|168|P|medication unless directed by your doctor. If you are planning||
5287|169|P|pregnancy, become pregnant, or think you may be pregnant,||
5287|170|P|immediately discuss with your doctor the benefits and risks of||
5287|171|P|using this medication during pregnancy.||
5287|172|P|   It is unknown if this drug passes into breast milk. Consult||
5287|173|P|your doctor before breastfeeding.||
5287|174|B|||
5287|175|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5287|176|I|medications work or increase your risk for serious side effects.||
5287|177|I|This document does not contain all possible drug interactions.||
5287|178|I|Keep a list of all the products you use (including||
5287|179|I|prescription/nonprescription drugs and herbal products) and share||
5287|180|I|it with your doctor and pharmacist. Do not start, stop, or change||
5287|181|I|the dosage of any medicines without your doctor's approval.||
5287|182|I|   Some products that may interact with this drug include:||
5287|183|I|cabergoline, lithium.||
5287|184|I|   Many drugs besides thioridazine may affect the heart rhythm||
5287|185|I|(QT prolongation), including amiodarone, dofetilide, pimozide,||
5287|186|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
5287|187|I|erythromycin), ziprasidone, among others.||
5287|188|I|   Other medications can affect the removal of thioridazine from||
5287|189|I|your body, which may affect how thioridazine works. Examples||
5287|190|I|include bupropion, cinacalcet, dacomitinib, duloxetine,||
5287|191|I|mirabegron, pindolol, propranolol, rolapitant, terbinafine,||
5287|192|I|certain SSRI antidepressants (such as fluoxetine, fluvoxamine,||
5287|193|I|paroxetine), among others.||
5287|194|I|   Thioridazine can speed up the removal of other drugs from your||
5287|195|I|body, which may affect how they work. Examples of affected drugs||
5287|196|I|include elacestrant, lonafarnib, mavacamten, among others.||
5287|197|I|   This medication may decrease the effectiveness of hormonal||
5287|198|I|birth control such as pills, patch, or ring. This could cause||
5287|199|I|pregnancy. Discuss with your doctor or pharmacist if you should||
5287|200|I|use reliable backup birth control methods while using this||
5287|201|I|medication. Also tell your doctor if you have any new spotting or||
5287|202|I|breakthrough bleeding, because these may be signs that your birth||
5287|203|I|control is not working well.||
5287|204|I|   Tell your doctor or pharmacist if you are taking other||
5287|205|I|products that cause drowsiness such as opioid pain or cough||
5287|206|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5287|207|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
5287|208|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5287|209|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5287|210|I|diphenhydramine).||
5287|211|I|   Check the labels on all your medicines (such as allergy or||
5287|212|I|cough-and-cold products) because they may contain ingredients||
5287|213|I|that cause drowsiness. Ask your pharmacist about using those||
5287|214|I|products safely.||
5287|215|B|||
5287|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5287|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5287|218|O|poison control center right away. US residents can call||
5287|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5287|220|B|||
5287|221|N|NOTES:  Do not share this medication with others.||
5287|222|N|   Lab and/or medical tests (such as eye exams, potassium levels,||
5287|223|N|EKG) may be done while you are taking this medication. Keep all||
5287|224|N|medical and lab appointments. Consult your doctor for more||
5287|225|N|details.||
5287|226|B|||
5287|227|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5287|228|D|remember. If it is near the time of the next dose, skip the||
5287|229|D|missed dose. Take your next dose at the regular time. Do not||
5287|230|D|double the dose to catch up.||
5287|231|B|||
5287|232|R|STORAGE:  Store at room temperature away from light and moisture.||
5287|233|R|Do not store in the bathroom. Keep all medications away from||
5287|234|R|children and pets.||
5287|235|R|   Do not flush medications down the toilet or pour them into a||
5287|236|R|drain unless instructed to do so. Properly discard this product||
5287|237|R|when it is expired or no longer needed. Consult your pharmacist||
5287|238|R|or local waste disposal company.||
5287|239|B|||
5287|240|A|Information last revised May 2025.||
5287|241|A|Copyright(c) 2025 First Databank, Inc.||
5287|242|B|||
5288|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5288|002|Z|does NOT have all possible information about this product. This||
5288|003|Z|information does not assure that this product is safe, effective,||
5288|004|Z|or appropriate for you. This information is not individual||
5288|005|Z|medical advice and does not substitute for the advice of your||
5288|006|Z|health care professional. Always ask your health care||
5288|007|Z|professional for complete information about this product and your||
5288|008|Z|specific health needs.||
5288|009|B|||
5288|010|T|ASCORBATE CALCIUM - ORAL||
5288|011|F|(a-SKOR-bate KAL-see-um)||
5288|012|B|||
5288|013|C|COMMON BRAND NAME(S): Ester-C||
5288|014|B|||
5288|015|U|USES:  Ascorbate calcium is a form of vitamin C that is used to||
5288|016|U|prevent or treat low levels of vitamin C in people who do not get||
5288|017|U|enough of the vitamin from their diets. This product also||
5288|018|U|contains calcium. Most people who eat a normal diet do not need||
5288|019|U|extra vitamin C. Low levels of vitamin C can result in a||
5288|020|U|condition called scurvy. Scurvy may cause symptoms such as rash,||
5288|021|U|muscle weakness, joint pain, tiredness, or tooth loss.||
5288|022|U|   Vitamin C plays an important role in the body. It is needed to||
5288|023|U|maintain the health of skin, cartilage, teeth, bone, and blood||
5288|024|U|vessels. It is also used to protect your body's cells from||
5288|025|U|damage. It is known as an antioxidant.||
5288|026|B|||
5288|027|V|OTHER USES:  This section contains uses of this drug that are not||
5288|028|V|listed in the approved professional labeling for the drug but||
5288|029|V|that may be prescribed by your health care professional. Use this||
5288|030|V|drug for a condition that is listed in this section only if it||
5288|031|V|has been so prescribed by your health care professional.||
5288|032|V|   Vitamin C may also be used with other vitamins for a certain||
5288|033|V|eye condition (macular degeneration).||
5288|034|B|||
5288|035|H|HOW TO USE:  Take this product by mouth with food, usually 1 to 2||
5288|036|H|times daily. Follow all directions on the product package, or||
5288|037|H|take as directed by your doctor. Take this product with a full||
5288|038|H|glass of water (8 ounces/240 milliliters) unless your doctor||
5288|039|H|directs you otherwise.||
5288|040|H|   If you are taking the chewable tablets, chew them thoroughly||
5288|041|H|and then swallow. If you are taking the sustained-release||
5288|042|H|tablets, swallow the medication whole. Do not crush, chew, or||
5288|043|H|break the tablets. If you are taking the powder, mix it||
5288|044|H|thoroughly in the proper amount of liquid and stir well. Drink||
5288|045|H|all of the liquid right away. Do not prepare a supply for future||
5288|046|H|use.||
5288|047|H|   The dosage is based on your medical condition and response to||
5288|048|H|treatment.||
5288|049|H|   Use this product regularly to get the most benefit from it. To||
5288|050|H|help you remember, take it at the same time(s) each day.||
5288|051|H|   If you think you may have a serious medical problem, get||
5288|052|H|medical help right away.||
5288|053|B|||
5288|054|S|SIDE EFFECTS:  Diarrhea, constipation, nausea, vomiting,||
5288|055|S|abdominal cramps/pain, or heartburn may occur. If any of these||
5288|056|S|effects last or get worse, tell your doctor or pharmacist||
5288|057|S|promptly.||
5288|058|S|   If your doctor has directed you to use this product, remember||
5288|059|S|that your doctor has judged that the benefit to you is greater||
5288|060|S|than the risk of side effects. Many people using this product do||
5288|061|S|not have serious side effects.||
5288|062|S|   Tell your doctor right away if you have any serious side||
5288|063|S|effects, including: painful urination, pink/bloody urine.||
5288|064|S|   A very serious allergic reaction to this drug is rare.||
5288|065|S|However, get medical help right away if you notice any symptoms||
5288|066|S|of a serious allergic reaction, including: rash, itching/swelling||
5288|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5288|068|S|breathing.||
5288|069|S|   This is not a complete list of possible side effects. If you||
5288|070|S|notice other effects not listed above, contact your doctor or||
5288|071|S|pharmacist.||
5288|072|S|   In the US -||
5288|073|S|   Call your doctor for medical advice about side effects. You||
5288|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5288|075|S|www.fda.gov/medwatch.||
5288|076|S|   In Canada - Call your doctor for medical advice about side||
5288|077|S|effects. You may report side effects to Health Canada at||
5288|078|S|1-866-234-2345.||
5288|079|B|||
5288|080|P|PRECAUTIONS:  Before taking ascorbate calcium, tell your doctor||
5288|081|P|or pharmacist if you are allergic to it; or if you have any other||
5288|082|P|allergies. This product may contain inactive ingredients, which||
5288|083|P|can cause allergic reactions or other problems. Talk to your||
5288|084|P|pharmacist for more details.||
5288|085|P|   Before using this product, tell your doctor or pharmacist your||
5288|086|P|medical history, especially of: kidney disease (such as kidney||
5288|087|P|stones), a certain enzyme deficiency (G6PD deficiency), high||
5288|088|P|calcium levels (hypercalcemia).||
5288|089|P|   Before having surgery, tell your doctor or dentist about all||
5288|090|P|the products you use (including prescription drugs,||
5288|091|P|nonprescription drugs, and herbal products).||
5288|092|P|   During pregnancy, vitamin C has been found to be safe when||
5288|093|P|used in recommended doses. Higher doses should be used during||
5288|094|P|pregnancy only if clearly needed. Discuss the risks and benefits||
5288|095|P|with your doctor.||
5288|096|P|   Vitamin C passes into breast milk and is considered to be safe||
5288|097|P|during breastfeeding when used in recommended doses. Consult your||
5288|098|P|doctor for more information.||
5288|099|B|||
5288|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5288|101|I|medications work or increase your risk for serious side effects.||
5288|102|I|This document does not contain all possible drug interactions.||
5288|103|I|Keep a list of all the products you use (including||
5288|104|I|prescription/nonprescription drugs and herbal products) and share||
5288|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
5288|106|I|the dosage of any medicines without your doctor's approval.||
5288|107|I|   The calcium in this product can decrease the absorption of||
5288|108|I|certain drugs, especially if you take them around the same time.||
5288|109|I|These drugs include bisphosphonates (such as alendronate),||
5288|110|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
5288|111|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
5288|112|I|minocycline), thyroid medications (such as levothyroxine), among||
5288|113|I|others. Ask your doctor or pharmacist how long you should wait||
5288|114|I|between doses of this product and your other medications and to||
5288|115|I|find a dosing schedule that works for all your medications.||
5288|116|I|   Check the labels on all your medicines and vitamins because||
5288|117|I|they may also contain vitamin C and/or calcium. Ask your||
5288|118|I|pharmacist about using those products safely.||
5288|119|I|   This medication may interfere with certain lab tests (such as||
5288|120|I|certain urine glucose tests), possibly causing false test||
5288|121|I|results. Make sure lab personnel and all your doctors know you||
5288|122|I|use this drug.||
5288|123|B|||
5288|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5288|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5288|126|O|poison control center right away. US residents can call||
5288|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5288|128|B|||
5288|129|N|NOTES:  Keep all medical and lab appointments.||
5288|130|N|   This product is not a substitute for a proper diet. It is best||
5288|131|N|to get your vitamins from healthy foods. Vitamin C is commonly||
5288|132|N|found in citrus fruit (such as oranges), tomatoes, brussels||
5288|133|N|sprouts, cauliflower, and broccoli, among others. Consult your||
5288|134|N|doctor, pharmacist, or nutritionist for more details.||
5288|135|B|||
5288|136|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5288|137|D|remember. If it is near the time of the next dose, skip the||
5288|138|D|missed dose. Take your next dose at the regular time. Do not||
5288|139|D|double the dose to catch up.||
5288|140|B|||
5288|141|R|STORAGE:  Different brands of this vitamin have different storage||
5288|142|R|needs. Check the product package for instructions on how to store||
5288|143|R|your brand, or ask your pharmacist. Keep all medications away||
5288|144|R|from children and pets.||
5288|145|R|   Do not flush medications down the toilet or pour them into a||
5288|146|R|drain unless instructed to do so. Properly discard this product||
5288|147|R|when it is expired or no longer needed. Consult your pharmacist||
5288|148|R|or local waste disposal company.||
5288|149|B|||
5288|150|A|Information last revised October 2025.||
5288|151|A|Copyright(c) 2025 First Databank, Inc.||
5288|152|B|||
5294|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5294|002|Z|does NOT have all possible information about this product. This||
5294|003|Z|information does not assure that this product is safe, effective,||
5294|004|Z|or appropriate for you. This information is not individual||
5294|005|Z|medical advice and does not substitute for the advice of your||
5294|006|Z|health care professional. Always ask your health care||
5294|007|Z|professional for complete information about this product and your||
5294|008|Z|specific health needs.||
5294|009|B|||
5294|010|T|OSELTAMIVIR - ORAL||
5294|011|F|(oss-el-TAM-eh-veer)||
5294|012|B|||
5294|013|C|COMMON BRAND NAME(S): Tamiflu||
5294|014|B|||
5294|015|U|USES:  Oseltamivir is used to treat symptoms caused by the flu||
5294|016|U|virus (influenza). It helps make the symptoms (such as stuffy||
5294|017|U|nose, cough, sore throat, fever/chills, aches, tiredness) less||
5294|018|U|severe and shortens the recovery time by 1-2 days.||
5294|019|U|   This medication may also be used to prevent the flu if you||
5294|020|U|have been exposed to someone who already has the flu (such as a||
5294|021|U|sick household member) or if there is a flu outbreak in the||
5294|022|U|community. Talk to your doctor for more details.||
5294|023|U|   This medication works by stopping the flu virus from growing.||
5294|024|U|It is not a substitute for the flu vaccine. (See also Notes||
5294|025|U|section.)||
5294|026|B|||
5294|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5294|028|H|from your pharmacist before you start taking this medicine. If||
5294|029|H|you have any questions, consult your doctor or pharmacist.||
5294|030|H|   Take this medication by mouth with or without food. You may||
5294|031|H|take it with food or milk to minimize stomach upset. Take this||
5294|032|H|medication as soon as flu symptoms appear or as soon as possible||
5294|033|H|after you have been exposed to the flu. Oseltamivir works best if||
5294|034|H|you start taking it within 2 days of either of these events.||
5294|035|H|   If you have the flu, take oseltamivir as directed by your||
5294|036|H|doctor, usually twice a day for 5 days.||
5294|037|H|   To prevent the flu, take oseltamivir as directed by your||
5294|038|H|doctor, usually once a day for at least 10 days. Follow your||
5294|039|H|doctor's instructions for how long to take this medicine.||
5294|040|H|   The dosage is based on your medical condition and response to||
5294|041|H|treatment. Children's dosage is also based on weight.||
5294|042|H|   If you cannot swallow the capsules, ask your doctor or||
5294|043|H|pharmacist about the liquid suspension form of oseltamivir. If||
5294|044|H|the liquid is not available and if directed by your doctor or||
5294|045|H|pharmacist, you may open up the capsule and mix the contents with||
5294|046|H|a small amount of sweetened liquid (such as regular/sugar-free||
5294|047|H|chocolate syrup, corn syrup, caramel topping, or light brown||
5294|048|H|sugar dissolved in water). Stir the mixture and take the entire||
5294|049|H|dose.||
5294|050|H|   For the best effect, take this medication at evenly spaced||
5294|051|H|times. To help you remember, take this medication at the same||
5294|052|H|time(s) every day. Continue to take this medication for the full||
5294|053|H|time prescribed, even if symptoms disappear after a few days.||
5294|054|H|Stopping the medication too early may result in a return of the||
5294|055|H|infection or failure to protect you from the flu.||
5294|056|H|   Tell your doctor if your condition lasts or gets worse or if||
5294|057|H|new symptoms appear.||
5294|058|B|||
5294|059|S|SIDE EFFECTS:  Nausea and vomiting may occur. If either of these||
5294|060|S|effects last or get worse, tell your doctor or pharmacist||
5294|061|S|promptly.||
5294|062|S|   Remember that this medication has been prescribed because your||
5294|063|S|doctor has judged that the benefit to you is greater than the||
5294|064|S|risk of side effects. Many people using this medication do not||
5294|065|S|have serious side effects.||
5294|066|S|   The flu itself or oseltamivir may rarely cause serious||
5294|067|S|mental/mood changes. This may be more likely in children. Tell||
5294|068|S|your doctor right away of any signs of unusual behavior,||
5294|069|S|including: confusion, agitation, self-injury.||
5294|070|S|   A very serious allergic reaction to this drug is rare.||
5294|071|S|However, get medical help right away if you notice any symptoms||
5294|072|S|of a serious allergic reaction, including: rash, itching/swelling||
5294|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5294|074|S|breathing.||
5294|075|S|   This is not a complete list of possible side effects. If you||
5294|076|S|notice other effects not listed above, contact your doctor or||
5294|077|S|pharmacist.||
5294|078|S|   In the US -||
5294|079|S|   Call your doctor for medical advice about side effects. You||
5294|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5294|081|S|www.fda.gov/medwatch.||
5294|082|S|   In Canada - Call your doctor for medical advice about side||
5294|083|S|effects. You may report side effects to Health Canada at||
5294|084|S|1-866-234-2345.||
5294|085|B|||
5294|086|P|PRECAUTIONS:  Before taking oseltamivir, tell your doctor or||
5294|087|P|pharmacist if you are allergic to it; or if you have any other||
5294|088|P|allergies. This product may contain inactive ingredients, which||
5294|089|P|can cause allergic reactions or other problems. Talk to your||
5294|090|P|pharmacist for more details.||
5294|091|P|   Before using this medication, tell your doctor or pharmacist||
5294|092|P|your medical history, especially of: kidney disease (including||
5294|093|P|dialysis treatment).||
5294|094|P|   Before having surgery, tell your doctor or dentist about all||
5294|095|P|the products you use (including prescription drugs,||
5294|096|P|nonprescription drugs, and herbal products).||
5294|097|P|   During pregnancy, this medication should be used only when||
5294|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
5294|099|P|   This medication passes into breast milk but is unlikely to||
5294|100|P|harm a nursing infant. Consult your doctor before breastfeeding.||
5294|101|B|||
5294|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5294|103|I|medications work or increase your risk for serious side effects.||
5294|104|I|This document does not contain all possible drug interactions.||
5294|105|I|Keep a list of all the products you use (including||
5294|106|I|prescription/nonprescription drugs and herbal products) and share||
5294|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
5294|108|I|the dosage of any medicines without your doctor's approval.||
5294|109|I|   Tell your doctor if you have received flu vaccine in the nose||
5294|110|I|within 2 weeks before treatment with this medication. This||
5294|111|I|medication may lower your protection from flu vaccine given in||
5294|112|I|the nose. Wait at least 2 days after ending treatment with this||
5294|113|I|medication before receiving flu vaccine given in the nose.||
5294|114|B|||
5294|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5294|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5294|117|O|poison control center right away. US residents can call||
5294|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5294|119|B|||
5294|120|N|NOTES:  Do not share this medication with others.||
5294|121|N|   This medication is not a substitute for the flu vaccine.||
5294|122|N|Consult your doctor about the risks and important benefits of||
5294|123|N|receiving a yearly flu shot to lower your chances of getting the||
5294|124|N|flu.||
5294|125|B|||
5294|126|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5294|127|D|remember. If it is within 2 hours of the next dose, skip the||
5294|128|D|missed dose. Take your next dose at the regular time. Do not||
5294|129|D|double the dose to catch up.||
5294|130|B|||
5294|131|R|STORAGE:  Store at room temperature away from light and moisture.||
5294|132|R|Do not store in the bathroom. Keep all medications away from||
5294|133|R|children and pets.||
5294|134|R|   Do not flush medications down the toilet or pour them into a||
5294|135|R|drain unless instructed to do so. Properly discard this product||
5294|136|R|when it is expired or no longer needed. Consult your pharmacist||
5294|137|R|or local waste disposal company.||
5294|138|B|||
5294|139|A|Information last revised August 2024.||
5294|140|A|Copyright(c) 2025 First Databank, Inc.||
5294|141|B|||
5296|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5296|002|Z|does NOT have all possible information about this product. This||
5296|003|Z|information does not assure that this product is safe, effective,||
5296|004|Z|or appropriate for you. This information is not individual||
5296|005|Z|medical advice and does not substitute for the advice of your||
5296|006|Z|health care professional. Always ask your health care||
5296|007|Z|professional for complete information about this product and your||
5296|008|Z|specific health needs.||
5296|009|B|||
5296|010|T|PALONOSETRON - INJECTION||
5296|011|F|(PAL-oh-NOE-se-tron)||
5296|012|B|||
5296|013|C|COMMON BRAND NAME(S): Aloxi||
5296|014|B|||
5296|015|U|USES:  This medication is used to prevent nausea and vomiting||
5296|016|U|caused by cancer drug treatment (chemotherapy). It is also used||
5296|017|U|to prevent nausea and vomiting after surgery. Palonosetron works||
5296|018|U|by blocking one of the body's natural substances (serotonin) that||
5296|019|U|causes vomiting.||
5296|020|B|||
5296|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5296|022|H|from your pharmacist before you start using palonosetron and each||
5296|023|H|time you get a refill. If you have any questions, ask your doctor||
5296|024|H|or pharmacist.||
5296|025|H|   This medication is given by injection into a vein by a health||
5296|026|H|care professional. It is given as directed by your doctor,||
5296|027|H|usually 30 minutes before the start of chemotherapy or right||
5296|028|H|before the start of surgery.||
5296|029|H|   The dosage is based on your medical condition and response to||
5296|030|H|treatment. Children's dosage is also based on weight.||
5296|031|H|   Tell your doctor if you vomit or feel nauseated.||
5296|032|B|||
5296|033|S|SIDE EFFECTS:  Pain, redness, or swelling at the injection site||
5296|034|S|may occur. Headache, constipation, or diarrhea may also occur. If||
5296|035|S|any of these effects last or get worse, tell your doctor or||
5296|036|S|pharmacist promptly.||
5296|037|S|   Remember that this medication has been prescribed because your||
5296|038|S|doctor has judged that the benefit to you is greater than the||
5296|039|S|risk of side effects. Many people using this medication do not||
5296|040|S|have serious side effects.||
5296|041|S|   This medication may increase serotonin and rarely cause a very||
5296|042|S|serious condition called serotonin syndrome/toxicity. The risk||
5296|043|S|increases if you are also taking other drugs that increase||
5296|044|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
5296|045|S|take (see Drug Interactions section). Get medical help right away||
5296|046|S|if you develop some of the following symptoms: fast heartbeat,||
5296|047|S|hallucinations, loss of coordination, severe dizziness, severe||
5296|048|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
5296|049|S|unusual agitation/restlessness.||
5296|050|S|   A very serious allergic reaction to this drug is rare.||
5296|051|S|However, get medical help right away if you notice any symptoms||
5296|052|S|of a serious allergic reaction, including: rash, itching/swelling||
5296|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5296|054|S|breathing.||
5296|055|S|   This is not a complete list of possible side effects. If you||
5296|056|S|notice other effects not listed above, contact your doctor or||
5296|057|S|pharmacist.||
5296|058|S|   In the US -||
5296|059|S|   Call your doctor for medical advice about side effects. You||
5296|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5296|061|S|www.fda.gov/medwatch.||
5296|062|S|   In Canada - Call your doctor for medical advice about side||
5296|063|S|effects. You may report side effects to Health Canada at||
5296|064|S|1-866-234-2345.||
5296|065|B|||
5296|066|P|PRECAUTIONS:  Before using palonosetron, tell your doctor or||
5296|067|P|pharmacist if you are allergic to it; or to other anti-nausea||
5296|068|P|serotonin blockers (such as ondansetron, granisetron); or if you||
5296|069|P|have any other allergies. This product may contain inactive||
5296|070|P|ingredients, which can cause allergic reactions or other||
5296|071|P|problems. Talk to your pharmacist for more details.||
5296|072|P|   Before using this medication, tell your doctor or pharmacist||
5296|073|P|your medical history.||
5296|074|P|   Before having surgery, tell your doctor or dentist about all||
5296|075|P|the products you use (including prescription drugs,||
5296|076|P|nonprescription drugs, and herbal products).||
5296|077|P|   During pregnancy, this medication should be used only when||
5296|078|P|clearly needed. Discuss the risks and benefits with your doctor.||
5296|079|P|   It is unknown if this medication passes into breast milk.||
5296|080|P|Consult your doctor before breastfeeding.||
5296|081|B|||
5296|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5296|083|I|medications work or increase your risk for serious side effects.||
5296|084|I|This document does not contain all possible drug interactions.||
5296|085|I|Keep a list of all the products you use (including||
5296|086|I|prescription/nonprescription drugs and herbal products) and share||
5296|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
5296|088|I|the dosage of any medicines without your doctor's approval.||
5296|089|I|   The risk of serotonin syndrome/toxicity increases if you are||
5296|090|I|also taking other drugs that increase serotonin. Examples include||
5296|091|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
5296|092|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
5296|093|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
5296|094|I|serotonin syndrome/toxicity may be more likely when you start or||
5296|095|I|increase the dose of these drugs.||
5296|096|B|||
5296|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5296|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5296|099|O|poison control center right away. US residents can call||
5296|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5296|101|B|||
5296|102|N|NOTES:  Not applicable.||
5296|103|B|||
5296|104|D|MISSED DOSE:  It is important to get each dose of this medication||
5296|105|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
5296|106|D|right away for a new dosing schedule. Do not double the dose to||
5296|107|D|catch up.||
5296|108|B|||
5296|109|R|STORAGE:  Not applicable. This medication is given in a clinic||
5296|110|R|and will not be stored at home.||
5296|111|B|||
5296|112|A|Information last revised August 2024.||
5296|113|A|Copyright(c) 2025 First Databank, Inc.||
5296|114|B|||
5298|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5298|002|Z|does NOT have all possible information about this product. This||
5298|003|Z|information does not assure that this product is safe, effective,||
5298|004|Z|or appropriate for you. This information is not individual||
5298|005|Z|medical advice and does not substitute for the advice of your||
5298|006|Z|health care professional. Always ask your health care||
5298|007|Z|professional for complete information about this product and your||
5298|008|Z|specific health needs.||
5298|009|B|||
5298|010|T|HYDROCODONE LIQUID - ORAL||
5298|011|F|(HYE-droe-KOE-done)||
5298|012|B|||
5298|013|W|WARNING:  This medication has a risk for abuse and addiction,||
5298|014|W|which can lead to overdose and death. This medication may also||
5298|015|W|cause severe, possibly fatal, breathing problems. To lower your||
5298|016|W|risk, your doctor should have you take the smallest dose that||
5298|017|W|works, and take it for the shortest possible time. See also How||
5298|018|W|to Use section for more information about addiction.||
5298|019|W|   The risk for severe breathing problems is higher when you||
5298|020|W|start this medication, or if you take the wrong dose or take more||
5298|021|W|of this medication than prescribed. Taking this medication with||
5298|022|W|alcohol or other drugs that can cause drowsiness or breathing||
5298|023|W|problems may cause very serious side effects, including death.||
5298|024|W|Also, other medications can affect the removal of this product||
5298|025|W|from your body, which may affect how it works. Be sure you know||
5298|026|W|how to take this product and what other drugs you should avoid||
5298|027|W|taking with it. See also Drug Interactions section. Get medical||
5298|028|W|help right away if any of these very serious side effects occur:||
5298|029|W|slow/shallow breathing, unusual lightheadedness, severe||
5298|030|W|drowsiness/dizziness, difficulty waking up.||
5298|031|W|   Keep this medicine in a safe place to prevent theft, misuse,||
5298|032|W|or abuse. If someone accidentally swallows this drug, get medical||
5298|033|W|help right away.||
5298|034|W|   Before using this medication, women of childbearing age should||
5298|035|W|talk with their doctor(s) about the risks and benefits. Tell your||
5298|036|W|doctor if you are pregnant or think you may be pregnant. During||
5298|037|W|pregnancy, this medication is not recommended. It may slightly||
5298|038|W|increase the risk of birth defects if used during the first two||
5298|039|W|months of pregnancy. Also, using it for a long time or in high||
5298|040|W|doses near the expected delivery date may harm the unborn baby.||
5298|041|W|To lessen the risk, take the smallest effective dose for the||
5298|042|W|shortest possible time. Babies born to mothers who use this drug||
5298|043|W|for a long time may develop severe (possibly fatal) withdrawal||
5298|044|W|symptoms. Tell the doctor right away if you notice any symptoms||
5298|045|W|in your newborn baby such as crying that doesn't stop,||
5298|046|W|slow/shallow breathing, irritability, shaking, vomiting,||
5298|047|W|diarrhea, poor feeding, or difficulty gaining weight.||
5298|048|B|||
5298|049|U|USES:  Hydrocodone is used to treat a dry cough caused by the||
5298|050|U|common cold or allergies. Hydrocodone is an opioid cough||
5298|051|U|suppressant (antitussive) that affects a certain part of the||
5298|052|U|brain, reducing the urge to cough. This medication is not usually||
5298|053|U|used for coughs with a lot of mucus. Coughing is a natural||
5298|054|U|response to help clear the lungs of mucus.||
5298|055|U|   Opioid cough suppressants should not be used by children||
5298|056|U|younger than 18 years. Children are at higher risk for serious||
5298|057|U|(even fatal) side effects, especially breathing problems. Talk||
5298|058|U|with the doctor about the risks and benefits of this medication.||
5298|059|U|   Cough-and-cold products do not cure colds. Cough due to a||
5298|060|U|common cold often does not need to be treated with medicine. Ask||
5298|061|U|your doctor or pharmacist about other ways to relieve cough and||
5298|062|U|cold symptoms, such as drinking enough fluids, using a||
5298|063|U|humidifier, or saline nose drops/spray.||
5298|064|B|||
5298|065|H|HOW TO USE:  Take this medication by mouth after meals, and at||
5298|066|H|bedtime with food or milk, as directed by your doctor. Wait at||
5298|067|H|least 4 hours between doses. Carefully measure the dose using a||
5298|068|H|special measuring device/spoon. Do not use a household spoon||
5298|069|H|because you may not get the correct dose.||
5298|070|H|   If you have nausea, ask your doctor or pharmacist about ways||
5298|071|H|to reduce it (such as lying down for 1 to 2 hours with as little||
5298|072|H|head movement as possible).||
5298|073|H|   The dosage is based on your medical condition and response to||
5298|074|H|treatment. Do not increase your dose or use this drug more often||
5298|075|H|or for longer than prescribed. Your condition will not improve||
5298|076|H|any faster, and your risk of side effects will increase.||
5298|077|H|   If you suddenly stop using this medication, you may have||
5298|078|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
5298|079|H|nose, nausea, sweating, muscle aches). To help prevent||
5298|080|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
5298|081|H|more likely if you have used hydrocodone for a long time (more||
5298|082|H|than a few weeks) or in high doses. Tell your doctor or||
5298|083|H|pharmacist right away if you have withdrawal.||
5298|084|H|   When this medication is used for a long time, it may not work||
5298|085|H|as well. Talk with your doctor if this medication stops working||
5298|086|H|well.||
5298|087|H|   Though it helps many people, this medication may sometimes||
5298|088|H|cause addiction. This risk may be higher if you have a||
5298|089|H|mental/mood disorder or a substance use disorder (such as overuse||
5298|090|H|of or addiction to drugs/alcohol). Take this medication exactly||
5298|091|H|as prescribed to lower the risk of addiction. Ask your doctor or||
5298|092|H|pharmacist for more details.||
5298|093|H|   Tell your doctor if your cough does not get better in 5 days||
5298|094|H|or if your condition gets worse.||
5298|095|B|||
5298|096|S|SIDE EFFECTS:  See also Warning section.||
5298|097|S|   Drowsiness, dizziness, lightheadedness, nausea, vomiting, or||
5298|098|S|constipation may occur. If any of these effects last or get||
5298|099|S|worse, tell your doctor or pharmacist promptly.||
5298|100|S|   To prevent constipation, eat dietary fiber, drink enough||
5298|101|S|water, and exercise. You may also need to take a laxative. Ask||
5298|102|S|your pharmacist which type of laxative is right for you.||
5298|103|S|   To reduce the risk of dizziness and lightheadedness, get up||
5298|104|S|slowly when rising from a sitting or lying position.||
5298|105|S|   Remember that this medication has been prescribed because your||
5298|106|S|doctor has judged that the benefit to you is greater than the||
5298|107|S|risk of side effects. Many people using this medication do not||
5298|108|S|have serious side effects.||
5298|109|S|   Tell your doctor right away if you have any serious side||
5298|110|S|effects, including: interrupted breathing during sleep (sleep||
5298|111|S|apnea), mental/mood changes (such as agitation, confusion,||
5298|112|S|hallucinations), stomach/abdominal pain, difficulty urinating,||
5298|113|S|signs of your adrenal glands not working well (such as loss of||
5298|114|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
5298|115|S|   Get medical help right away if you have any very serious side||
5298|116|S|effects, including: fainting, slow/shallow breathing, severe||
5298|117|S|drowsiness/difficulty waking up, seizure.||
5298|118|S|   A very serious allergic reaction to this drug is rare.||
5298|119|S|However, get medical help right away if you notice any symptoms||
5298|120|S|of a serious allergic reaction, including: rash, itching/swelling||
5298|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5298|122|S|breathing.||
5298|123|S|   This is not a complete list of possible side effects. If you||
5298|124|S|notice other side effects not listed above, contact your doctor||
5298|125|S|or pharmacist.||
5298|126|S|   In the US -||
5298|127|S|   Call your doctor for medical advice about side effects. You||
5298|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5298|129|S|www.fda.gov/medwatch.||
5298|130|S|   In Canada - Call your doctor for medical advice about side||
5298|131|S|effects. You may report side effects to Health Canada at||
5298|132|S|1-866-234-2345.||
5298|133|B|||
5298|134|P|PRECAUTIONS:  Before taking hydrocodone, tell your doctor or||
5298|135|P|pharmacist if you are allergic to it; or to other opioids (such||
5298|136|P|as benzhydrocodone, codeine, hydromorphone, morphine); or if you||
5298|137|P|have any other allergies. This product may contain inactive||
5298|138|P|ingredients, which can cause allergic reactions or other||
5298|139|P|problems. Talk to your pharmacist for more details.||
5298|140|P|   Before using this medication, tell your doctor or pharmacist||
5298|141|P|your medical history, especially of: adrenal gland problem (such||
5298|142|P|as Addison's disease), brain disorders (such as head injury,||
5298|143|P|tumor, seizures), breathing problems (such as asthma, sleep||
5298|144|P|apnea, chronic obstructive pulmonary disease-COPD), gallbladder||
5298|145|P|disease, kidney disease, liver disease, mental/mood disorders||
5298|146|P|(such as confusion, depression, thoughts of suicide), personal or||
5298|147|P|family history of a substance use disorder (such as overuse of or||
5298|148|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
5298|149|P|blockage, constipation, diarrhea due to infection, paralytic||
5298|150|P|ileus), disease of the pancreas (pancreatitis), difficulty||
5298|151|P|urinating (such as due to enlarged prostate).||
5298|152|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5298|153|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5298|154|P|machinery, or do anything that needs alertness until you can do||
5298|155|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5298|156|P|are using marijuana (cannabis).||
5298|157|P|   Before having surgery, tell your doctor or dentist about all||
5298|158|P|the products you use (including prescription drugs,||
5298|159|P|nonprescription drugs, and herbal products).||
5298|160|P|   This medication may contain sugar. Caution is advised if you||
5298|161|P|have diabetes. Ask your doctor or pharmacist about using this||
5298|162|P|product safely.||
5298|163|P|   Older adults may be more sensitive to the side effects of this||
5298|164|P|drug, especially confusion, dizziness, drowsiness, and||
5298|165|P|slow/shallow breathing.||
5298|166|P|   Tell your doctor if you are pregnant or think you may be||
5298|167|P|pregnant. During pregnancy, this product is not recommended. It||
5298|168|P|may harm an unborn baby. Talk to your doctor about the risks and||
5298|169|P|benefits of this medication. See also Warning section.||
5298|170|P|   This product passes into breast milk and may have undesirable||
5298|171|P|effects on a nursing infant (such as unusual sleepiness,||
5298|172|P|difficulty feeding, trouble breathing, or unusual limpness).||
5298|173|P|Breastfeeding is not recommended while using this product.||
5298|174|P|Consult your doctor before breastfeeding.||
5298|175|B|||
5298|176|I|DRUG INTERACTIONS:  See also Warning section.||
5298|177|I|   Drug interactions may change how your medications work or||
5298|178|I|increase your risk for serious side effects. This document does||
5298|179|I|not contain all possible drug interactions. Keep a list of all||
5298|180|I|the products you use (including prescription/nonprescription||
5298|181|I|drugs and herbal products) and share it with your doctor and||
5298|182|I|pharmacist. Do not start, stop, or change the dosage of any||
5298|183|I|medicines without your doctor's approval.||
5298|184|I|   Some products that may interact with this drug include:||
5298|185|I|certain pain medications (mixed opioid agonist-antagonists such||
5298|186|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
5298|187|I|samidorphan.||
5298|188|I|   The risk of serious side effects (such as slow/shallow||
5298|189|I|breathing, severe drowsiness/dizziness) may be increased if this||
5298|190|I|medication is taken with other products that may also cause||
5298|191|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5298|192|I|if you are taking other products such as other opioid pain or||
5298|193|I|cough relievers (such as codeine, hydromorphone), alcohol,||
5298|194|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
5298|195|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
5298|196|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
5298|197|I|cetirizine, diphenhydramine).||
5298|198|I|   Check the labels on all your medicines (such as allergy or||
5298|199|I|cough-and-cold products) because they may contain ingredients||
5298|200|I|that cause drowsiness. Ask your pharmacist about using those||
5298|201|I|products safely.||
5298|202|I|   Other medications can affect the removal of hydrocodone from||
5298|203|I|your body, which may affect how hydrocodone works. Examples||
5298|204|I|include azole antifungals (such as ketoconazole), macrolide||
5298|205|I|antibiotics (such as erythromycin), mifepristone, HIV medications||
5298|206|I|(such as tipranavir), rifamycins (such as rifabutin, rifampin),||
5298|207|I|ritonavir, certain drugs used to treat seizures (such as||
5298|208|I|carbamazepine, phenytoin), among others.||
5298|209|I|   This medication may interfere with certain lab tests (such as||
5298|210|I|amylase/lipase levels), possibly causing false test results. Make||
5298|211|I|sure lab personnel and all your doctors know you use this drug.||
5298|212|B|||
5298|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5298|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5298|215|O|poison control center right away. US residents can call||
5298|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5298|217|O|Symptoms of overdose may include: slow heartbeat, slow breathing,||
5298|218|O|coma.||
5298|219|B|||
5298|220|N|NOTES:  Do not share this medication with others. Sharing it is||
5298|221|N|against the law.||
5298|222|N|   This medication has been prescribed for your current condition||
5298|223|N|only. Do not use it later for another condition unless told to do||
5298|224|N|so by your doctor. A different medication may be necessary in||
5298|225|N|that case.||
5298|226|B|||
5298|227|D|MISSED DOSE:  If you are taking this on a regular schedule and||
5298|228|D|miss a dose, take it as soon as you remember. If it is near the||
5298|229|D|time of the next dose, skip the missed dose. Take your next dose||
5298|230|D|at the regular time. Do not double the dose to catch up.||
5298|231|B|||
5298|232|R|STORAGE:  Store at room temperature. Keep all medications away||
5298|233|R|from children and pets.||
5298|234|R|   Do not flush medications down the toilet or pour them into a||
5298|235|R|drain unless instructed to do so. Properly discard this product||
5298|236|R|when it is expired or no longer needed. Consult your pharmacist||
5298|237|R|or local waste disposal company.||
5298|238|B|||
5298|239|A|Information last revised August 2025.||
5298|240|A|Copyright(c) 2025 First Databank, Inc.||
5298|241|B|||
5301|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5301|002|Z|does NOT have all possible information about this product. This||
5301|003|Z|information does not assure that this product is safe, effective,||
5301|004|Z|or appropriate for you. This information is not individual||
5301|005|Z|medical advice and does not substitute for the advice of your||
5301|006|Z|health care professional. Always ask your health care||
5301|007|Z|professional for complete information about this product and your||
5301|008|Z|specific health needs.||
5301|009|B|||
5301|010|T|SIROLIMUS - ORAL||
5301|011|F|(sir-OH-li-mus)||
5301|012|B|||
5301|013|C|COMMON BRAND NAME(S): Rapamune||
5301|014|B|||
5301|015|W|WARNING:  Sirolimus lowers the body's ability to fight an||
5301|016|W|infection/disease (immunosuppression). This may increase your||
5301|017|W|risk of developing an infection or certain types of cancer (such||
5301|018|W|as skin cancer, lymphoma). To reduce the risk of these serious||
5301|019|W|side effects, take this medication at the lowest effective dose||
5301|020|W|as directed by your doctor. Keep all medical and lab||
5301|021|W|appointments.||
5301|022|W|   Tell your doctor right away if you develop any of the||
5301|023|W|following: unusual skin changes, change in the appearance/size of||
5301|024|W|moles, unusual growths/lumps, swollen lymph nodes, night sweats,||
5301|025|W|unexplained weight loss, signs of infection (such as sore throat||
5301|026|W|that doesn't go away, fever, chills).||
5301|027|W|   Sirolimus is not recommended for the prevention of rejection||
5301|028|W|of liver or lung transplants because it has rarely caused very||
5301|029|W|serious (possibly fatal) liver/lung problems in those cases.||
5301|030|B|||
5301|031|U|USES:  Sirolimus is used with other medications to prevent||
5301|032|U|rejection of a kidney transplant. This medication belongs to a||
5301|033|U|class of drugs known as immunosuppressants. It works by weakening||
5301|034|U|your body's defense system (immune system) to help your body||
5301|035|U|accept the new organ as if it were your own.||
5301|036|U|   Sirolimus may also be used to treat a certain lung disease||
5301|037|U|(lymphangioleiomyomatosis-LAM).||
5301|038|B|||
5301|039|V|OTHER USES:  This section contains uses of this drug that are not||
5301|040|V|listed in the approved professional labeling for the drug but||
5301|041|V|that may be prescribed by your health care professional. Use this||
5301|042|V|drug for a condition that is listed in this section only if it||
5301|043|V|has been so prescribed by your health care professional.||
5301|044|V|   This drug may also be used to reduce the risk of rejection of||
5301|045|V|a heart transplant.||
5301|046|B|||
5301|047|H|HOW TO USE:  Read the Medication Guide provided by your||
5301|048|H|pharmacist before you start taking sirolimus and each time you||
5301|049|H|get a refill. If you have any questions, ask your doctor or||
5301|050|H|pharmacist.||
5301|051|H|   Take this medication by mouth as directed by your doctor,||
5301|052|H|usually once daily. Swallow this medication whole. Do not crush,||
5301|053|H|chew, or split the tablets. If you have nausea or an upset||
5301|054|H|stomach, you may take this medication with food. However, it is||
5301|055|H|important to choose one way (with food or without food) and take||
5301|056|H|this medication the same way with every dose. Consult your doctor||
5301|057|H|or pharmacist for more details.||
5301|058|H|   The dosage is based on your weight, medical condition, lab||
5301|059|H|tests, and response to treatment.||
5301|060|H|   Take this medication regularly to get the most benefit from||
5301|061|H|it. To help you remember, take it at the same time each day.||
5301|062|H|   Do not increase your dose or take this medication more often||
5301|063|H|than prescribed. Your condition will not improve any faster, and||
5301|064|H|your risk of side effects will increase. Also, do not stop taking||
5301|065|H|this medication without consulting your doctor.||
5301|066|H|   If you are also taking cyclosporine, take sirolimus 4 hours||
5301|067|H|after your cyclosporine dose. Consult your pharmacist for more||
5301|068|H|information.||
5301|069|H|   Avoid eating grapefruit or drinking grapefruit juice while||
5301|070|H|using this medication unless your doctor or pharmacist says you||
5301|071|H|may do so safely. Grapefruit can increase the chance of side||
5301|072|H|effects with this medicine. Ask your doctor or pharmacist for||
5301|073|H|more details.||
5301|074|H|   If you are taking this medication to treat LAM, tell your||
5301|075|H|doctor if your condition gets worse.||
5301|076|B|||
5301|077|S|SIDE EFFECTS:  See also Warning section.||
5301|078|S|   Diarrhea, joint pain, shaking, acne, or trouble sleeping may||
5301|079|S|occur. If any of these effects last or get worse, tell your||
5301|080|S|doctor or pharmacist promptly.||
5301|081|S|   Remember that this medication has been prescribed because your||
5301|082|S|doctor has judged that the benefit to you is greater than the||
5301|083|S|risk of side effects. Many people using this medication do not||
5301|084|S|have serious side effects.||
5301|085|S|   Tell your doctor right away if you have any serious side||
5301|086|S|effects, including: nausea/vomiting that doesn't stop, yellowing||
5301|087|S|eyes/skin, dark urine, muscle pain/cramps, bone pain, increased||
5301|088|S|thirst/hunger, frequent urination, hearing problems (such as||
5301|089|S|hearing loss, ringing in the ears), unusual tiredness,||
5301|090|S|fast/slow/irregular heartbeat, easy bruising/bleeding,||
5301|091|S|mental/mood changes, swelling ankles/feet, severe headache,||
5301|092|S|dizziness, stomach/abdominal pain, missed/heavy/painful periods,||
5301|093|S|signs of kidney problems (such as change in the amount of urine,||
5301|094|S|frothy urine), pain/redness/swelling of arms or legs, swelling||
5301|095|S|abdomen.||
5301|096|S|   Get medical help right away if you have any very serious side||
5301|097|S|effects, including: chest pain, shortness of breath.||
5301|098|S|   This medication may increase your risk of getting a rare but||
5301|099|S|very serious (possibly fatal) brain infection (progressive||
5301|100|S|multifocal leukoencephalopathy-PML). Get medical help right away||
5301|101|S|if you have any of these side effects: clumsiness, loss of||
5301|102|S|coordination/balance, weakness, sudden change in your thinking||
5301|103|S|(such as confusion, difficulty concentrating, memory loss),||
5301|104|S|difficulty talking/walking, seizure, vision changes.||
5301|105|S|   Sirolimus may slow wound healing after surgery. Tell your||
5301|106|S|doctor right away if you have signs that your surgery wound is||
5301|107|S|not healing well (such as redness, swelling, pain). The risk of||
5301|108|S|poor wound healing is higher if you are obese.||
5301|109|S|   Sirolimus may cause your cholesterol/triglycerides to||
5301|110|S|increase. You may be required to have your||
5301|111|S|cholesterol/triglycerides checked periodically and/or take||
5301|112|S|another medication to control your cholesterol/triglycerides.||
5301|113|S|   Sirolimus can commonly cause a rash that is usually not||
5301|114|S|serious. However, you may not be able to tell it apart from a||
5301|115|S|rare rash that could be a sign of a severe reaction. Get medical||
5301|116|S|help right away if you develop any rash.||
5301|117|S|   A very serious allergic reaction to this drug is rare.||
5301|118|S|However, get medical help right away if you notice any symptoms||
5301|119|S|of a serious allergic reaction, including: rash, itching/swelling||
5301|120|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5301|121|S|breathing.||
5301|122|S|   This is not a complete list of possible side effects. If you||
5301|123|S|notice other effects not listed above, contact your doctor or||
5301|124|S|pharmacist.||
5301|125|S|   In the US -||
5301|126|S|   Call your doctor for medical advice about side effects. You||
5301|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5301|128|S|www.fda.gov/medwatch.||
5301|129|S|   In Canada - Call your doctor for medical advice about side||
5301|130|S|effects. You may report side effects to Health Canada at||
5301|131|S|1-866-234-2345.||
5301|132|B|||
5301|133|P|PRECAUTIONS:  Before taking sirolimus, tell your doctor or||
5301|134|P|pharmacist if you are allergic to it; or to temsirolimus; or if||
5301|135|P|you have any other allergies. This product may contain inactive||
5301|136|P|ingredients, which can cause allergic reactions or other||
5301|137|P|problems. Talk to your pharmacist for more details.||
5301|138|P|   Before using this medication, tell your doctor or pharmacist||
5301|139|P|your medical history, especially of: liver disease, high||
5301|140|P|cholesterol/triglyceride levels, cancer, any recent/current||
5301|141|P|infections.||
5301|142|P|   Sirolimus can make you more likely to get infections or may||
5301|143|P|make current infections worse. Stay away from anyone who has an||
5301|144|P|infection that may easily spread (such as chickenpox, COVID-19,||
5301|145|P|measles, flu). Talk to your doctor if you have been exposed to an||
5301|146|P|infection or for more details.||
5301|147|P|   Tell your health care professional that you are using||
5301|148|P|sirolimus before having any immunizations/vaccinations. Avoid||
5301|149|P|contact with people who have recently received live vaccines||
5301|150|P|(such as flu vaccine inhaled through the nose).||
5301|151|P|   This medication may increase your risk of developing skin||
5301|152|P|cancer. Limit your time in the sun. Avoid tanning booths and||
5301|153|P|sunlamps. Use sunscreen and wear protective clothing when||
5301|154|P|outdoors.||
5301|155|P|   Before having surgery, tell your doctor or dentist about all||
5301|156|P|the products you use (including prescription drugs,||
5301|157|P|nonprescription drugs, and herbal products).||
5301|158|P|   This medication can affect fertility in males. Ask your doctor||
5301|159|P|for more details.||
5301|160|P|   Tell your doctor if you are pregnant or plan to become||
5301|161|P|pregnant. You should not become pregnant while using sirolimus.||
5301|162|P|Sirolimus may harm an unborn baby. Ask about reliable forms of||
5301|163|P|birth control while using this medication and for 12 weeks after||
5301|164|P|the last dose. If you become pregnant, talk to your doctor right||
5301|165|P|away about the risks and benefits of this medication.||
5301|166|P|   This medication may pass into breast milk and may have||
5301|167|P|undesirable effects on a nursing infant. Breastfeeding is not||
5301|168|P|recommended while using this medication. Consult your doctor||
5301|169|P|before breastfeeding.||
5301|170|B|||
5301|171|I|DRUG INTERACTIONS:  See also How to Use section.||
5301|172|I|   Drug interactions may change how your medications work or||
5301|173|I|increase your risk for serious side effects. This document does||
5301|174|I|not contain all possible drug interactions. Keep a list of all||
5301|175|I|the products you use (including prescription/nonprescription||
5301|176|I|drugs and herbal products) and share it with your doctor and||
5301|177|I|pharmacist. Do not start, stop, or change the dosage of any||
5301|178|I|medicines without your doctor's approval.||
5301|179|I|   Some products that may interact with this drug include: ACE||
5301|180|I|inhibitors (such as benazepril, lisinopril), other drugs that||
5301|181|I|weaken the immune system/increase the risk of infection (such as||
5301|182|I|natalizumab, rituximab, tacrolimus).||
5301|183|I|   Other medications can affect the removal of sirolimus from||
5301|184|I|your body, which may affect how sirolimus works. Examples include||
5301|185|I|azole antifungals (such as itraconazole, ketoconazole,||
5301|186|I|voriconazole), enzalutamide, macrolide antibiotics (such as||
5301|187|I|clarithromycin, erythromycin), mifepristone, rifamycins (such as||
5301|188|I|rifampin, rifabutin), ritonavir, St. John's wort, among others.||
5301|189|I|   Sirolimus is very similar to temsirolimus. Do not use||
5301|190|I|medications containing temsirolimus while using sirolimus.||
5301|191|B|||
5301|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5301|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5301|194|O|poison control center right away. US residents can call||
5301|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5301|196|B|||
5301|197|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
5301|198|N|cholesterol/triglyceride levels, urine tests for protein,||
5301|199|N|sirolimus trough level) will be done while you are taking this||
5301|200|N|medication. Keep all medical and lab appointments. Consult your||
5301|201|N|doctor for more details.||
5301|202|N|   If you had an organ transplant, attend a transplant education||
5301|203|N|class or support group to learn more about the signs of organ||
5301|204|N|rejection such as a feeling of being ill, fever, or||
5301|205|N|tenderness/pain around the transplanted organ. Tell your doctor||
5301|206|N|right away if you notice any of these signs.||
5301|207|B|||
5301|208|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5301|209|D|remember. If it is near the time of the next dose, skip the||
5301|210|D|missed dose. Take your next dose at the regular time. Do not||
5301|211|D|double the dose to catch up.||
5301|212|B|||
5301|213|R|STORAGE:  Store at room temperature away from light and moisture.||
5301|214|R|Do not store in the bathroom. Keep all medications away from||
5301|215|R|children and pets.||
5301|216|R|   Do not flush medications down the toilet or pour them into a||
5301|217|R|drain unless instructed to do so. Properly discard this product||
5301|218|R|when it is expired or no longer needed. Consult your pharmacist||
5301|219|R|or local waste disposal company.||
5301|220|B|||
5301|221|M|MEDICAL ALERT:  Your condition can cause complications in a||
5301|222|M|medical emergency. For information about enrolling in MedicAlert,||
5301|223|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5301|224|B|||
5301|225|A|Information last revised May 2025.||
5301|226|A|Copyright(c) 2025 First Databank, Inc.||
5301|227|B|||
5303|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5303|002|Z|does NOT have all possible information about this product. This||
5303|003|Z|information does not assure that this product is safe, effective,||
5303|004|Z|or appropriate for you. This information is not individual||
5303|005|Z|medical advice and does not substitute for the advice of your||
5303|006|Z|health care professional. Always ask your health care||
5303|007|Z|professional for complete information about this product and your||
5303|008|Z|specific health needs.||
5303|009|B|||
5303|010|T|PNEUMOCOCCAL CONJUGATE VACCINE - INJECTION||
5303|011|F|(NEU-mo-KOK-al KON-jih-gut)||
5303|012|B|||
5303|013|C|COMMON BRAND NAME(S): Capvaxive, Prevnar 13, Prevnar 20||
5303|014|B|||
5303|015|U|USES:  This vaccine is used to help prevent pneumococcal disease,||
5303|016|U|an infection caused by a certain bacteria (Streptococcus||
5303|017|U|pneumoniae). This bacteria can cause ear infections or other more||
5303|018|U|serious infections (such as pneumonia, meningitis, blood||
5303|019|U|infection). Vaccination is the best way to protect against this||
5303|020|U|disease. This vaccine works by increasing the body's natural||
5303|021|U|defense (immunity) against the bacteria.||
5303|022|U|   Vaccines may not fully protect everyone who receives them.||
5303|023|B|||
5303|024|H|HOW TO USE:  Read all vaccine information available from your||
5303|025|H|health care professional before receiving the vaccine. If you||
5303|026|H|have any questions, ask your health care professional.||
5303|027|H|   This vaccine is given by injection into a muscle by a health||
5303|028|H|care professional. It is given in the upper arm for children and||
5303|029|H|adults and in the thigh for infants.||
5303|030|H|   Vaccines are usually given in a series of doses to provide the||
5303|031|H|best protection. In some cases, this vaccine may be given only||
5303|032|H|once. Closely follow the vaccination schedule provided by your||
5303|033|H|health care professional. To help you remember, mark your||
5303|034|H|calendar with a reminder.||
5303|035|B|||
5303|036|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
5303|037|S|muscle/joint aches, fever, tiredness, headache, irritability,||
5303|038|S|loss of appetite, nausea, or diarrhea may occur. If any of these||
5303|039|S|effects last or get worse, tell your health care professional||
5303|040|S|promptly.||
5303|041|S|   Rarely, some people have symptoms such as fainting, dizziness,||
5303|042|S|vision changes, or ringing in the ears just after getting a||
5303|043|S|vaccine injection. Tell your health care professional right away||
5303|044|S|if you have any of these symptoms. Sitting or lying down may||
5303|045|S|help, since these symptoms usually don't last long.||
5303|046|S|   Remember that this vaccine has been prescribed because your||
5303|047|S|health care professional has judged that the benefit to you is||
5303|048|S|greater than the risk of side effects. Many people using this||
5303|049|S|vaccine do not have serious side effects.||
5303|050|S|   Tell your health care professional right away if you have any||
5303|051|S|serious side effects, including: seizures.||
5303|052|S|   A very serious allergic reaction to this vaccine is rare.||
5303|053|S|However, get medical help right away if you notice any symptoms||
5303|054|S|of a serious allergic reaction, including: rash, itching/swelling||
5303|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5303|056|S|breathing.||
5303|057|S|   This is not a complete list of possible side effects. If you||
5303|058|S|notice other effects not listed above, contact your health care||
5303|059|S|professional.||
5303|060|S|   Contact the health care professional for medical advice about||
5303|061|S|side effects. The following numbers do not provide medical||
5303|062|S|advice, but in the US you may report side effects to the Vaccine||
5303|063|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
5303|064|S|Canada, you may call the Vaccine Safety Section at Public Health||
5303|065|S|Agency of Canada at 1-866-844-0018.||
5303|066|B|||
5303|067|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
5303|068|P|care professional if you are allergic to it; or if you have any||
5303|069|P|other allergies. This product may contain inactive ingredients||
5303|070|P|(such as latex or dry natural rubber that can be found in the||
5303|071|P|product packaging), which can cause allergic reactions or other||
5303|072|P|problems. Talk to your health care professional for more details.||
5303|073|P|   Before receiving this vaccine, tell your health care||
5303|074|P|professional your medical history, especially of: current||
5303|075|P|fever/illness, immune system disorders (such as due to HIV||
5303|076|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
5303|077|P|radiation treatment), vaccination history (including previous||
5303|078|P|reactions to any vaccines).||
5303|079|P|   During pregnancy, this vaccine should be used only when||
5303|080|P|clearly needed. Discuss the risks and benefits with your health||
5303|081|P|care professional.||
5303|082|P|   It is unknown if this vaccine passes into breast milk. Consult||
5303|083|P|your health care professional before breastfeeding.||
5303|084|B|||
5303|085|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5303|086|I|medications work or increase your risk for serious side effects.||
5303|087|I|This document does not contain all possible drug interactions.||
5303|088|I|Keep a list of all the products you use (including||
5303|089|I|prescription/nonprescription drugs and herbal products) and share||
5303|090|I|it with your health care professional. Do not start, stop, or||
5303|091|I|change the dosage of any medicines without your doctor's||
5303|092|I|approval.||
5303|093|I|   Some products that may interact with this vaccine are: drugs||
5303|094|I|that weaken the immune system (including cyclosporine,||
5303|095|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
5303|096|I|prednisone).||
5303|097|B|||
5303|098|O|OVERDOSE:  Not applicable.||
5303|099|B|||
5303|100|N|NOTES:  Keep all medical and lab appointments.||
5303|101|N|   Keep vaccine records for yourself and your children and||
5303|102|N|provide them to the health care professionals to prevent||
5303|103|N|unnecessary re-vaccinations.||
5303|104|B|||
5303|105|D|MISSED DOSE:  It is important that you get each vaccination as||
5303|106|D|scheduled. Ask when you should get each dose and mark your||
5303|107|D|calendar with a reminder. If you miss a dose, call the health||
5303|108|D|care professional to reschedule.||
5303|109|B|||
5303|110|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
5303|111|R|medications away from children and pets.||
5303|112|R|   Do not flush medications down the toilet or pour them into a||
5303|113|R|drain unless instructed to do so. Properly discard this product||
5303|114|R|when it is expired or no longer needed. Consult your pharmacist||
5303|115|R|or local waste disposal company.||
5303|116|B|||
5303|117|A|Information last revised February 2025.||
5303|118|A|Copyright(c) 2025 First Databank, Inc.||
5303|119|B|||
5310|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5310|002|Z|does NOT have all possible information about this product. This||
5310|003|Z|information does not assure that this product is safe, effective,||
5310|004|Z|or appropriate for you. This information is not individual||
5310|005|Z|medical advice and does not substitute for the advice of your||
5310|006|Z|health care professional. Always ask your health care||
5310|007|Z|professional for complete information about this product and your||
5310|008|Z|specific health needs.||
5310|009|B|||
5310|010|T|RISEDRONATE WEEKLY - ORAL||
5310|011|F|(riss-ED-row-nate)||
5310|012|B|||
5310|013|C|COMMON BRAND NAME(S): Actonel||
5310|014|B|||
5310|015|U|USES:  Risedronate is used to prevent and treat certain types of||
5310|016|U|bone loss (osteoporosis) in adults. Osteoporosis causes bones to||
5310|017|U|become thinner and break more easily. Your chance of developing||
5310|018|U|osteoporosis increases as you age, after menopause, or if you are||
5310|019|U|taking corticosteroid medications (such as prednisone) for a long||
5310|020|U|time.||
5310|021|U|   This medication works by slowing bone loss to help maintain||
5310|022|U|strong bones and reduce the risk of broken bones (fractures).||
5310|023|U|Risedronate belongs to a class of medications called||
5310|024|U|bisphosphonates.||
5310|025|B|||
5310|026|H|HOW TO USE:  Read the Medication Guide and, if available, the||
5310|027|H|Patient Information Leaflet provided by your pharmacist before||
5310|028|H|you start taking risedronate and each time you get a refill.||
5310|029|H|Follow the instructions very closely to make sure you absorb as||
5310|030|H|much of the drug as possible and reduce the risk of injury to||
5310|031|H|your esophagus. If you have any questions, ask your doctor or||
5310|032|H|pharmacist.||
5310|033|H|   Take this medication by mouth as directed by your doctor,||
5310|034|H|usually once per week. Choose the day of the week that best fits||
5310|035|H|your schedule. Take this medication after getting up for the day,||
5310|036|H|before taking your first food, beverage, or other medication. Do||
5310|037|H|not take it at bedtime or while you are still in bed.||
5310|038|H|   Take this medication with a full glass of plain water (6 to 8||
5310|039|H|ounces or 180 to 240 milliliters). Do not take it with any other||
5310|040|H|beverages. Swallow the tablet whole. Do not chew or suck on it.||
5310|041|H|Then stay fully upright (sitting, standing, or walking) for at||
5310|042|H|least 30 minutes and do not lie down until after your first food||
5310|043|H|of the day. Wait at least 30 minutes after taking risedronate||
5310|044|H|before you eat or drink anything other than plain water and||
5310|045|H|before taking any other medication by mouth.||
5310|046|H|   Calcium or iron supplements, vitamins with minerals, antacids||
5310|047|H|containing calcium/magnesium/aluminum, dairy products (such as||
5310|048|H|milk, yogurt), and juice with added calcium may interfere with||
5310|049|H|absorption of risedronate. Medications such as quinapril,||
5310|050|H|sucralfate, and bismuth subsalicylate may also interfere with||
5310|051|H|absorption. Do not take these products for at least 30 minutes||
5310|052|H|after taking risedronate.||
5310|053|H|   Take this medication regularly to get the most benefit from||
5310|054|H|it. To help you remember, take it on the same day each week. Mark||
5310|055|H|your calendar with a reminder. Talk to your doctor about the||
5310|056|H|risks and benefits of long-term use of this medication.||
5310|057|H|   Continue to take other medications for your condition as||
5310|058|H|directed by your doctor.||
5310|059|B|||
5310|060|S|SIDE EFFECTS:  Stomach upset may occur. If this effect lasts or||
5310|061|S|gets worse, tell your doctor or pharmacist promptly.||
5310|062|S|   Remember that this medication has been prescribed because your||
5310|063|S|doctor has judged that the benefit to you is greater than the||
5310|064|S|risk of side effects. Many people using this medication do not||
5310|065|S|have serious side effects.||
5310|066|S|   Tell your doctor right away if you have any serious side||
5310|067|S|effects, including: increased or severe bone/joint/muscle pain,||
5310|068|S|new or unusual hip/thigh/groin pain, jaw pain, eye/vision||
5310|069|S|problems.||
5310|070|S|   This medication may rarely cause irritation and ulcers in your||
5310|071|S|stomach or esophagus. Get medical help right away if any of these||
5310|072|S|serious side effects occur: new/severe/worsening heartburn, chest||
5310|073|S|pain, difficult or painful swallowing, severe stomach/abdominal||
5310|074|S|pain, black/tarry stools, vomit that looks like coffee grounds.||
5310|075|S|   A very serious allergic reaction to this drug is rare.||
5310|076|S|However, get medical help right away if you notice any symptoms||
5310|077|S|of a serious allergic reaction, including: rash, itching/swelling||
5310|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5310|079|S|breathing.||
5310|080|S|   This is not a complete list of possible side effects. If you||
5310|081|S|notice other effects not listed above, contact your doctor or||
5310|082|S|pharmacist.||
5310|083|S|   In the US -||
5310|084|S|   Call your doctor for medical advice about side effects. You||
5310|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5310|086|S|www.fda.gov/medwatch.||
5310|087|S|   In Canada - Call your doctor for medical advice about side||
5310|088|S|effects. You may report side effects to Health Canada at||
5310|089|S|1-866-234-2345.||
5310|090|B|||
5310|091|P|PRECAUTIONS:  Before taking risedronate, tell your doctor or||
5310|092|P|pharmacist if you are allergic to it; or to other bisphosphonates||
5310|093|P|(such as alendronate, etidronate, pamidronate); or if you have||
5310|094|P|any other allergies. This product may contain inactive||
5310|095|P|ingredients, which can cause allergic reactions or other||
5310|096|P|problems. Talk to your pharmacist for more details.||
5310|097|P|   Before using this medication, tell your doctor or pharmacist||
5310|098|P|your medical history, especially of: esophagus problems (such as||
5310|099|P|heartburn, narrowing of the esophagus, achalasia), difficult or||
5310|100|P|painful swallowing, low levels of calcium in the blood||
5310|101|P|(hypocalcemia), inability to sit upright or stand for at least 30||
5310|102|P|minutes, stomach/intestinal disorders (such as ulcers), severe||
5310|103|P|kidney disease.||
5310|104|P|   Some people taking risedronate may have serious jawbone||
5310|105|P|problems. Your doctor should check your mouth before you start||
5310|106|P|this medication. Tell your dentist that you are taking this||
5310|107|P|medication before you have any dental work done. To help prevent||
5310|108|P|jawbone problems, have regular dental exams and learn how to keep||
5310|109|P|your teeth and gums healthy. If you have jaw pain, tell your||
5310|110|P|doctor and dentist right away.||
5310|111|P|   Before having any surgery (especially dental procedures), tell||
5310|112|P|your doctor and dentist about this medication and all other||
5310|113|P|products you use (including prescription drugs, nonprescription||
5310|114|P|drugs, and herbal products). Your doctor or dentist may tell you||
5310|115|P|to stop taking risedronate before your surgery. Ask for specific||
5310|116|P|instructions about stopping or starting this medication.||
5310|117|P|   Tell your doctor if you are pregnant or plan to become||
5310|118|P|pregnant. Risedronate may stay in your body for many years. You||
5310|119|P|should not become pregnant while using risedronate. Discuss the||
5310|120|P|risks and benefits with your doctor.||
5310|121|P|   It is unknown if this drug passes into breast milk. Consult||
5310|122|P|your doctor before breastfeeding.||
5310|123|B|||
5310|124|I|DRUG INTERACTIONS:  See also How to Use section.||
5310|125|I|   Drug interactions may change how your medications work or||
5310|126|I|increase your risk for serious side effects. This document does||
5310|127|I|not contain all possible drug interactions. Keep a list of all||
5310|128|I|the products you use (including prescription/nonprescription||
5310|129|I|drugs and herbal products) and share it with your doctor and||
5310|130|I|pharmacist. Do not start, stop, or change the dosage of any||
5310|131|I|medicines without your doctor's approval.||
5310|132|I|   This medication may interfere with certain lab tests (such as||
5310|133|I|bone-imaging tests), possibly causing false test results. Make||
5310|134|I|sure lab personnel and all your doctors know you use this drug.||
5310|135|B|||
5310|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5310|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5310|138|O|poison control center right away. US residents can call||
5310|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5310|140|B|||
5310|141|N|NOTES:  Do not share this medication with others.||
5310|142|N|   Lifestyle changes that help promote healthy bones include||
5310|143|N|increasing weight-bearing exercise, stopping smoking, limiting||
5310|144|N|alcohol, and eating well-balanced meals that contain adequate||
5310|145|N|calcium and vitamin D. Since you may also need to take calcium||
5310|146|N|and vitamin D supplements and make lifestyle changes, consult||
5310|147|N|your doctor for specific advice.||
5310|148|N|   Lab and/or medical tests (x-rays, height, blood mineral||
5310|149|N|levels) should be done while you are taking this medication. Keep||
5310|150|N|all medical and lab appointments. Consult your doctor for more||
5310|151|N|details.||
5310|152|B|||
5310|153|D|MISSED DOSE:  If you miss a dose, do not take it later in the||
5310|154|D|day. Take it the next morning after you remember. Keep taking||
5310|155|D|your weekly dose on your originally scheduled day of the week. Do||
5310|156|D|not take two doses on the same day. Consult your doctor or||
5310|157|D|pharmacist if you have any questions.||
5310|158|B|||
5310|159|R|STORAGE:  Store at room temperature away from light and moisture.||
5310|160|R|Do not store in the bathroom. Keep all medications away from||
5310|161|R|children and pets.||
5310|162|R|   Do not flush medications down the toilet or pour them into a||
5310|163|R|drain unless instructed to do so. Properly discard this product||
5310|164|R|when it is expired or no longer needed. Consult your pharmacist||
5310|165|R|or local waste disposal company.||
5310|166|B|||
5310|167|A|Information last revised September 2025.||
5310|168|A|Copyright(c) 2025 First Databank, Inc.||
5310|169|B|||
5313|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5313|002|Z|does NOT have all possible information about this product. This||
5313|003|Z|information does not assure that this product is safe, effective,||
5313|004|Z|or appropriate for you. This information is not individual||
5313|005|Z|medical advice and does not substitute for the advice of your||
5313|006|Z|health care professional. Always ask your health care||
5313|007|Z|professional for complete information about this product and your||
5313|008|Z|specific health needs.||
5313|009|B|||
5313|010|T|GLUCOSAMINE - ORAL||
5313|011|F|(gloo-KOSE-a-meen)||
5313|012|B|||
5313|013|U|USES:  Glucosamine has been used for arthritis (osteoarthritis).||
5313|014|U|   Some herbal/diet supplement products have been found to||
5313|015|U|contain possibly harmful impurities/additives. Check with your||
5313|016|U|pharmacist for more details about the brand you use.||
5313|017|U|   The FDA has not reviewed this product for safety or||
5313|018|U|effectiveness. Consult your doctor or pharmacist for more||
5313|019|U|details.||
5313|020|B|||
5313|021|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
5313|022|H|directions and warnings on the product package. If you have any||
5313|023|H|questions, ask your doctor or pharmacist.||
5313|024|H|   If you are taking the powder, mix it thoroughly in the proper||
5313|025|H|amount of liquid and stir well. Drink all of the liquid right||
5313|026|H|away. Do not prepare a supply for future use.||
5313|027|H|   It may take 4 to 8 weeks for this product to start working.||
5313|028|H|Tell your doctor if your condition lasts or gets worse. If you||
5313|029|H|think you may have a serious medical problem, get medical help||
5313|030|H|right away.||
5313|031|B|||
5313|032|S|SIDE EFFECTS:  Diarrhea, constipation, nausea, vomiting, or||
5313|033|S|heartburn may occur. If any of these effects last or get worse,||
5313|034|S|tell your doctor or pharmacist promptly.||
5313|035|S|   If your doctor has directed you to use this medication,||
5313|036|S|remember that your doctor has judged that the benefit to you is||
5313|037|S|greater than the risk of side effects. Many people using this||
5313|038|S|medication do not have serious side effects.||
5313|039|S|   A very serious allergic reaction to this product is rare.||
5313|040|S|However, get medical help right away if you notice any symptoms||
5313|041|S|of a serious allergic reaction, including: rash, itching/swelling||
5313|042|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5313|043|S|breathing.||
5313|044|S|   This is not a complete list of possible side effects. If you||
5313|045|S|notice other effects not listed above, contact your doctor or||
5313|046|S|pharmacist.||
5313|047|S|   In the US -||
5313|048|S|   Call your doctor for medical advice about side effects. You||
5313|049|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5313|050|S|www.fda.gov/medwatch.||
5313|051|S|   In Canada - Call your doctor for medical advice about side||
5313|052|S|effects. You may report side effects to Health Canada at||
5313|053|S|1-866-234-2345.||
5313|054|B|||
5313|055|P|PRECAUTIONS:  Before taking glucosamine, tell your doctor or||
5313|056|P|pharmacist if you are allergic to it; or to shellfish (such as||
5313|057|P|shrimp, crab); or if you have any other allergies. This product||
5313|058|P|may contain inactive ingredients, which can cause allergic||
5313|059|P|reactions or other problems. Talk to your pharmacist for more||
5313|060|P|details.||
5313|061|P|   If you have any of the following health problems, consult your||
5313|062|P|doctor or pharmacist before using this product: diabetes, asthma.||
5313|063|P|   Liquid forms of this product may contain sugar, aspartame||
5313|064|P|and/or alcohol. Caution is advised if you have diabetes, liver||
5313|065|P|disease, phenylketonuria (PKU), or any other condition that||
5313|066|P|requires you to limit/avoid these substances in your diet. Ask||
5313|067|P|your doctor or pharmacist about using this product safely.||
5313|068|P|   Tell your doctor if you are pregnant before using this||
5313|069|P|medication.||
5313|070|P|   It is unknown if this product passes into breast milk. Consult||
5313|071|P|your doctor before breastfeeding.||
5313|072|B|||
5313|073|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5313|074|I|medications work or increase your risk for serious side effects.||
5313|075|I|This document does not contain all possible drug interactions.||
5313|076|I|Keep a list of all the products you use (including||
5313|077|I|prescription/nonprescription drugs and herbal products) and share||
5313|078|I|it with your doctor and pharmacist. Do not start, stop, or change||
5313|079|I|the dosage of any medicines without your doctor's approval.||
5313|080|I|   Some products that may interact with this drug include:||
5313|081|I|certain chemotherapy drugs (teniposide, doxorubicin).||
5313|082|B|||
5313|083|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5313|084|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5313|085|O|poison control center right away. US residents can call||
5313|086|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5313|087|B|||
5313|088|N|NOTES:  Keep all medical and lab appointments.||
5313|089|B|||
5313|090|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5313|091|D|If it is near the time of the next dose, skip the missed dose.||
5313|092|D|Use your next dose at the regular time. Do not double the dose to||
5313|093|D|catch up.||
5313|094|B|||
5313|095|R|STORAGE:  Refer to storage information printed on the package. If||
5313|096|R|you have any questions about storage, ask your pharmacist. Keep||
5313|097|R|all medications and herbal products away from children and pets.||
5313|098|R|   Do not flush medications down the toilet or pour them into a||
5313|099|R|drain unless instructed to do so. Properly discard this product||
5313|100|R|when it is expired or no longer needed. Consult your pharmacist||
5313|101|R|or local waste disposal company.||
5313|102|B|||
5313|103|A|Information last revised May 2024.||
5313|104|A|Copyright(c) 2025 First Databank, Inc.||
5313|105|B|||
5321|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5321|002|Z|does NOT have all possible information about this product. This||
5321|003|Z|information does not assure that this product is safe, effective,||
5321|004|Z|or appropriate for you. This information is not individual||
5321|005|Z|medical advice and does not substitute for the advice of your||
5321|006|Z|health care professional. Always ask your health care||
5321|007|Z|professional for complete information about this product and your||
5321|008|Z|specific health needs.||
5321|009|B|||
5321|010|T|GRAMICIDIN/POLYMYXIN B - OPHTHALMIC/OTIC||
5321|011|F|(gram-ih-SIE-din/paw-lee-MIX-in B)||
5321|012|B|||
5321|013|U|USES:  This medication is a combination of antibiotics used to||
5321|014|U|treat or prevent eye or ear infections.||
5321|015|B|||
5321|016|H|HOW TO USE:  For best results, use this medication exactly as||
5321|017|H|directed. This medication is used as directed by your doctor,||
5321|018|H|usually 2 to 4 times daily. It is important to use this drug at||
5321|019|H|evenly spaced intervals.||
5321|020|H|   Continue to use this medication for the full time prescribed,||
5321|021|H|even if symptoms disappear after a few days. Stopping the||
5321|022|H|medication too early may result in a return of the infection.||
5321|023|H|   Tell your doctor if your condition does not get better in||
5321|024|H|several days.||
5321|025|H|   EYE: To apply eye drops, wash your hands first. To avoid||
5321|026|H|contamination, do not touch the dropper tip or let it touch your||
5321|027|H|eye or any other surface.||
5321|028|H|   If you are wearing contact lenses, remove them before using||
5321|029|H|the eye drops. Tilt your head back, look upward, and pull down||
5321|030|H|the lower eyelid to make a pouch. Place the dropper directly over||
5321|031|H|the eye and apply the prescribed number of drops. Look downward||
5321|032|H|and gently close your eye for 1 to 2 minutes. Place one finger at||
5321|033|H|the inside corner of your eye near your nose and apply gentle||
5321|034|H|pressure. This will prevent the medication from draining away.||
5321|035|H|Try not to blink and do not rub the eye. Do not rinse the||
5321|036|H|dropper. Replace the cap tightly after use.||
5321|037|H|   If you are also using other eye drops, wait at least 5 minutes||
5321|038|H|before applying other medications.||
5321|039|H|   Wait several minutes for your vision to clear before driving||
5321|040|H|or operating machinery.||
5321|041|H|   EAR: To apply ear drops, wash your hands first. To avoid||
5321|042|H|contamination, do not touch the dropper tip or let it touch your||
5321|043|H|ear or any other surface. Lie on your side or tilt the affected||
5321|044|H|ear upward. Place the dropper directly over the ear and use the||
5321|045|H|prescribed number of drops.||
5321|046|H|   To roll drops into the ear, pull the ear lobe up and back for||
5321|047|H|adults, and down and back for children.||
5321|048|H|   Keep the head tilted for about 2 minutes or insert a soft||
5321|049|H|cotton plug if directed by your doctor. Do not rinse the dropper.||
5321|050|H|Replace the cap tightly after use.||
5321|051|B|||
5321|052|S|SIDE EFFECTS:  Redness, burning, stinging, or itching of the eye||
5321|053|S|or ear, or blurred vision may occur for a few minutes after||
5321|054|S|applying the drops. If any of these effects last or get worse,||
5321|055|S|tell your doctor or pharmacist promptly.||
5321|056|S|   Remember that this medication has been prescribed because your||
5321|057|S|doctor has judged that the benefit to you is greater than the||
5321|058|S|risk of side effects. Many people using this medication do not||
5321|059|S|have serious side effects.||
5321|060|S|   A very serious allergic reaction to this drug is rare.||
5321|061|S|However, get medical help right away if you notice any symptoms||
5321|062|S|of a serious allergic reaction, including: rash, severe||
5321|063|S|itching/swelling (especially of the face/tongue/throat),||
5321|064|S|dizziness, trouble breathing.||
5321|065|S|   This is not a complete list of possible side effects. If you||
5321|066|S|notice other effects not listed above, contact your doctor or||
5321|067|S|pharmacist.||
5321|068|S|   In the US -||
5321|069|S|   Call your doctor for medical advice about side effects. You||
5321|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5321|071|S|www.fda.gov/medwatch.||
5321|072|S|   In Canada - Call your doctor for medical advice about side||
5321|073|S|effects. You may report side effects to Health Canada at||
5321|074|S|1-866-234-2345.||
5321|075|B|||
5321|076|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
5321|077|P|pharmacist if you are allergic to it; or if you have any other||
5321|078|P|allergies. This product may contain inactive ingredients, which||
5321|079|P|can cause allergic reactions or other problems. Talk to your||
5321|080|P|pharmacist for more details.||
5321|081|P|   Before using this medication, tell your doctor or pharmacist||
5321|082|P|your medical history, especially of: other eye or ear problems.||
5321|083|P|   After you apply this drug, your vision may become temporarily||
5321|084|P|blurred. Do not drive, use machinery, or do anything that needs||
5321|085|P|clear vision until you can do it safely.||
5321|086|P|   During pregnancy, this medication should be used only when||
5321|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
5321|088|P|   It is unknown if this drug passes into breast milk. Consult||
5321|089|P|your doctor before breastfeeding.||
5321|090|B|||
5321|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5321|092|I|medications work or increase your risk for serious side effects.||
5321|093|I|This document does not contain all possible drug interactions.||
5321|094|I|Keep a list of all the products you use (including||
5321|095|I|prescription/nonprescription drugs and herbal products) and share||
5321|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
5321|097|I|the dosage of any medicines without your doctor's approval.||
5321|098|B|||
5321|099|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
5321|100|O|has overdosed and has serious symptoms such as passing out or||
5321|101|O|trouble breathing, call 911. Otherwise, call a poison control||
5321|102|O|center right away. US residents can call 1-800-222-1222. Canada||
5321|103|O|residents can call 1-844-764-7669.||
5321|104|B|||
5321|105|N|NOTES:  Do not share this medication with others.||
5321|106|B|||
5321|107|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5321|108|D|If it is near the time of the next dose, skip the missed dose.||
5321|109|D|Use your next dose at the regular time. Do not double the dose to||
5321|110|D|catch up.||
5321|111|B|||
5321|112|R|STORAGE:  Store at room temperature. Once the bottle is opened,||
5321|113|R|this medication expires after 30 days. Keep all medications away||
5321|114|R|from children and pets.||
5321|115|R|   Do not flush medications down the toilet or pour them into a||
5321|116|R|drain unless instructed to do so. Properly discard this product||
5321|117|R|when it is expired or no longer needed. Consult your pharmacist||
5321|118|R|or local waste disposal company.||
5321|119|B|||
5321|120|A|Information last revised November 2024.||
5321|121|A|Copyright(c) 2025 First Databank, Inc.||
5321|122|B|||
5324|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5324|002|Z|does NOT have all possible information about this product. This||
5324|003|Z|information does not assure that this product is safe, effective,||
5324|004|Z|or appropriate for you. This information is not individual||
5324|005|Z|medical advice and does not substitute for the advice of your||
5324|006|Z|health care professional. Always ask your health care||
5324|007|Z|professional for complete information about this product and your||
5324|008|Z|specific health needs.||
5324|009|B|||
5324|010|T|DESLORATADINE - ORAL||
5324|011|F|(des-lor-AT-uh-deen)||
5324|012|B|||
5324|013|C|COMMON BRAND NAME(S): Clarinex||
5324|014|B|||
5324|015|U|USES:  Desloratadine is an antihistamine used to relieve allergy||
5324|016|U|symptoms such as watery eyes, runny nose, itching eyes/nose,||
5324|017|U|sneezing, hives, and itching. It works by blocking a certain||
5324|018|U|natural substance (histamine) that your body makes during an||
5324|019|U|allergic reaction.||
5324|020|B|||
5324|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5324|022|H|from your pharmacist before you start taking desloratadine and||
5324|023|H|each time you get a refill. If you have any questions, ask your||
5324|024|H|doctor or pharmacist.||
5324|025|H|   Take this medication by mouth with or without food as directed||
5324|026|H|by your doctor, usually once daily.||
5324|027|H|   If you are using the rapidly-dissolving tablet, allow the||
5324|028|H|tablet to dissolve on the tongue and then swallow, with or||
5324|029|H|without water. Do not remove the tablet from the blister pack||
5324|030|H|until right before using. If you are using the liquid form of||
5324|031|H|this medication, carefully measure the dose using a special||
5324|032|H|measuring device/spoon. Do not use a household spoon because you||
5324|033|H|may not get the correct dose.||
5324|034|H|   The dosage is based on your age, medical condition, and||
5324|035|H|response to treatment. Do not increase your dose or take this||
5324|036|H|medication more often than directed.||
5324|037|H|   Tell your doctor if your condition does not get better or if||
5324|038|H|it gets worse.||
5324|039|B|||
5324|040|S|SIDE EFFECTS:  Sore throat, nausea, tiredness, stomach upset, or||
5324|041|S|muscle pain may occur. Fever, loss of appetite, diarrhea, or||
5324|042|S|trouble sleeping may also occur, especially in children. If any||
5324|043|S|of these effects last or get worse, tell your doctor or||
5324|044|S|pharmacist promptly.||
5324|045|S|   Remember that this medication has been prescribed because your||
5324|046|S|doctor has judged that the benefit to you is greater than the||
5324|047|S|risk of side effects. Many people using this medication do not||
5324|048|S|have serious side effects.||
5324|049|S|   A very serious allergic reaction to this drug is rare.||
5324|050|S|However, get medical help right away if you notice any symptoms||
5324|051|S|of a serious allergic reaction, including: rash, itching/swelling||
5324|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5324|053|S|breathing.||
5324|054|S|   This is not a complete list of possible side effects. If you||
5324|055|S|notice other effects not listed above, contact your doctor or||
5324|056|S|pharmacist.||
5324|057|S|   In the US -||
5324|058|S|   Call your doctor for medical advice about side effects. You||
5324|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5324|060|S|www.fda.gov/medwatch.||
5324|061|S|   In Canada - Call your doctor for medical advice about side||
5324|062|S|effects. You may report side effects to Health Canada at||
5324|063|S|1-866-234-2345.||
5324|064|B|||
5324|065|P|PRECAUTIONS:  Before taking desloratadine, tell your doctor or||
5324|066|P|pharmacist if you are allergic to it; or to loratadine; or if you||
5324|067|P|have any other allergies. This product may contain inactive||
5324|068|P|ingredients, which can cause allergic reactions or other||
5324|069|P|problems. Talk to your pharmacist for more details.||
5324|070|P|   Before using this medication, tell your doctor or pharmacist||
5324|071|P|your medical history, especially of: kidney disease, liver||
5324|072|P|disease.||
5324|073|P|   Desloratadine does not usually cause drowsiness when used at||
5324|074|P|recommended doses. However, do not drive, use machinery, or do||
5324|075|P|anything that needs alertness until you can do it safely.||
5324|076|P|   Before having surgery, tell your doctor or dentist about all||
5324|077|P|the products you use (including prescription drugs,||
5324|078|P|nonprescription drugs, and herbal products).||
5324|079|P|   Liquid products and the rapidly-dissolving tablets may contain||
5324|080|P|sugar. The rapidly-dissolving tablets may also contain aspartame.||
5324|081|P|Caution is advised if you have diabetes, phenylketonuria (PKU),||
5324|082|P|or any other condition that requires you to limit/avoid these||
5324|083|P|substances in your diet. Ask your doctor or pharmacist about||
5324|084|P|using this product safely.||
5324|085|P|   During pregnancy, this medication should be used only when||
5324|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
5324|087|P|   This drug passes into breast milk. Consult your doctor before||
5324|088|P|breastfeeding.||
5324|089|B|||
5324|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5324|091|I|medications work or increase your risk for serious side effects.||
5324|092|I|This document does not contain all possible drug interactions.||
5324|093|I|Keep a list of all the products you use (including||
5324|094|I|prescription/nonprescription drugs and herbal products) and share||
5324|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
5324|096|I|the dosage of any medicines without your doctor's approval.||
5324|097|I|   Desloratadine is very similar to loratadine. Do not use||
5324|098|I|medications containing loratadine while using desloratadine.||
5324|099|I|   This medication may interfere with certain lab tests (such as||
5324|100|I|allergy skin testing), possibly causing false test results. Make||
5324|101|I|sure lab personnel and all your doctors know you use this drug.||
5324|102|B|||
5324|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5324|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5324|105|O|poison control center right away. US residents can call||
5324|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5324|107|O|Symptoms of overdose may include: drowsiness.||
5324|108|B|||
5324|109|N|NOTES:  Do not share this medication with others.||
5324|110|B|||
5324|111|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5324|112|D|remember. If it is near the time of the next dose, skip the||
5324|113|D|missed dose. Take your next dose at the regular time. Do not||
5324|114|D|double the dose to catch up.||
5324|115|B|||
5324|116|R|STORAGE:  Store at room temperature away from light and moisture.||
5324|117|R|Do not store in the bathroom. Keep all medications away from||
5324|118|R|children and pets.||
5324|119|R|   Do not flush medications down the toilet or pour them into a||
5324|120|R|drain unless instructed to do so. Properly discard this product||
5324|121|R|when it is expired or no longer needed. Consult your pharmacist||
5324|122|R|or local waste disposal company.||
5324|123|B|||
5324|124|A|Information last revised April 2025.||
5324|125|A|Copyright(c) 2025 First Databank, Inc.||
5324|126|B|||
5326|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5326|002|Z|does NOT have all possible information about this product. This||
5326|003|Z|information does not assure that this product is safe, effective,||
5326|004|Z|or appropriate for you. This information is not individual||
5326|005|Z|medical advice and does not substitute for the advice of your||
5326|006|Z|health care professional. Always ask your health care||
5326|007|Z|professional for complete information about this product and your||
5326|008|Z|specific health needs.||
5326|009|B|||
5326|010|T|VORICONAZOLE - ORAL||
5326|011|F|(VOR-i-KON-a-zole)||
5326|012|B|||
5326|013|C|COMMON BRAND NAME(S): Vfend||
5326|014|B|||
5326|015|U|USES:  Voriconazole is used to treat a variety of fungal||
5326|016|U|infections. It belongs to a class of drugs known as azole||
5326|017|U|antifungals. It works by stopping the growth of fungi.||
5326|018|B|||
5326|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5326|020|H|from your pharmacist before you start taking voriconazole and||
5326|021|H|each time you get a refill. If you have any questions, ask your||
5326|022|H|doctor or pharmacist.||
5326|023|H|   Take this medication by mouth without food (at least 1 hour||
5326|024|H|before or 1 hour after meals) as directed by your doctor, usually||
5326|025|H|every 12 hours.||
5326|026|H|   The dosage and length of treatment are based on your medical||
5326|027|H|condition, weight, response to treatment, and other medications||
5326|028|H|you may be taking. Be sure to tell your doctor and pharmacist||
5326|029|H|about all the products you use (including prescription drugs,||
5326|030|H|nonprescription drugs, and herbal products).||
5326|031|H|   For the best effect, take this antifungal at evenly spaced||
5326|032|H|times. To help you remember, take this medication at the same||
5326|033|H|times every day.||
5326|034|H|   Continue to take this medication until the full prescribed||
5326|035|H|amount is finished, even if symptoms disappear after a few days.||
5326|036|H|Stopping the medication too early may result in a return of the||
5326|037|H|infection.||
5326|038|H|   Tell your doctor if your condition does not get better or if||
5326|039|H|it gets worse.||
5326|040|B|||
5326|041|S|SIDE EFFECTS:  Nausea/vomiting and headache may occur. If any of||
5326|042|S|these effects last or get worse, tell your doctor or pharmacist||
5326|043|S|promptly.||
5326|044|S|   Remember that this medication has been prescribed because your||
5326|045|S|doctor has judged that the benefit to you is greater than the||
5326|046|S|risk of side effects. Many people using this medication do not||
5326|047|S|have serious side effects.||
5326|048|S|   Tell your doctor right away if you have any serious side||
5326|049|S|effects, including: vision changes (such as blurred vision, color||
5326|050|S|vision changes), sensitivity of eyes to light (photophobia), eye||
5326|051|S|pain, signs of kidney problems (such as change in the amount of||
5326|052|S|urine), bone/joint pain, mental/mood changes (such as||
5326|053|S|hallucinations), swelling hands/ankles/feet, easy||
5326|054|S|bruising/bleeding, unusual skin changes, signs of your adrenal||
5326|055|S|glands not working well (such as loss of appetite, unusual||
5326|056|S|tiredness, weight loss).||
5326|057|S|   Get medical help right away if you have any very serious side||
5326|058|S|effects, including: fast/irregular heartbeat, severe dizziness,||
5326|059|S|fainting.||
5326|060|S|   Voriconazole has rarely caused very serious (possibly fatal)||
5326|061|S|liver disease. Tell your doctor right away if you develop||
5326|062|S|symptoms of liver disease, such as: nausea/vomiting that doesn't||
5326|063|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
5326|064|S|eyes/skin, dark urine.||
5326|065|S|   A very serious allergic reaction to this drug is rare.||
5326|066|S|However, get medical help right away if you notice any symptoms||
5326|067|S|of a serious allergic reaction, including: fever that doesn't go||
5326|068|S|away, new or worsening lymph node swelling, rash,||
5326|069|S|itching/swelling (especially of the face/tongue/throat), severe||
5326|070|S|dizziness, trouble breathing.||
5326|071|S|   Voriconazole can commonly cause a mild rash that is usually||
5326|072|S|not serious. However, you may not be able to tell it apart from a||
5326|073|S|rare rash that could be a sign of a severe allergic reaction. Get||
5326|074|S|medical help right away if you develop any rash.||
5326|075|S|   This is not a complete list of possible side effects. If you||
5326|076|S|notice other effects not listed above, contact your doctor or||
5326|077|S|pharmacist.||
5326|078|S|   In the US -||
5326|079|S|   Call your doctor for medical advice about side effects. You||
5326|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5326|081|S|www.fda.gov/medwatch.||
5326|082|S|   In Canada - Call your doctor for medical advice about side||
5326|083|S|effects. You may report side effects to Health Canada at||
5326|084|S|1-866-234-2345.||
5326|085|B|||
5326|086|P|PRECAUTIONS:  Before taking voriconazole, tell your doctor or||
5326|087|P|pharmacist if you are allergic to it; or to other azole||
5326|088|P|antifungals (such as itraconazole); or if you have any other||
5326|089|P|allergies. This product may contain inactive ingredients (such as||
5326|090|P|lactose), which can cause allergic reactions or other problems.||
5326|091|P|Talk to your pharmacist for more details.||
5326|092|P|   Before using this medication, tell your doctor or pharmacist||
5326|093|P|your medical history, especially of: liver disease, heart||
5326|094|P|problems (such as irregular heartbeat).||
5326|095|P|   Voriconazole may cause a condition that affects the heart||
5326|096|P|rhythm (QT prolongation). QT prolongation can rarely cause||
5326|097|P|serious (rarely fatal) fast/irregular heartbeat and other||
5326|098|P|symptoms (such as severe dizziness, fainting) that need medical||
5326|099|P|attention right away.||
5326|100|P|   The risk of QT prolongation may be increased if you have||
5326|101|P|certain medical conditions or are taking other drugs that may||
5326|102|P|cause QT prolongation. Before using voriconazole, tell your||
5326|103|P|doctor or pharmacist of all the drugs you take and if you have||
5326|104|P|any of the following conditions: certain heart problems (heart||
5326|105|P|failure, slow heartbeat, QT prolongation in the EKG), family||
5326|106|P|history of certain heart problems (QT prolongation in the EKG,||
5326|107|P|sudden cardiac death).||
5326|108|P|   Low levels of potassium or magnesium in the blood may also||
5326|109|P|increase your risk of QT prolongation. This risk may increase if||
5326|110|P|you use certain drugs (such as diuretics/"water pills") or if you||
5326|111|P|have conditions such as severe sweating, diarrhea, or vomiting.||
5326|112|P|Talk to your doctor about using voriconazole safely.||
5326|113|P|   This drug may cause vision changes. Do not drive, use||
5326|114|P|machinery, or do anything that needs clear vision until you can||
5326|115|P|do it safely. Do not drive at night.||
5326|116|P|   Avoid alcoholic beverages since they can increase the risk of||
5326|117|P|serious liver problems.||
5326|118|P|   This medication may make you more sensitive to the sun. It may||
5326|119|P|also increase your risk for skin cancer, especially if you take||
5326|120|P|it for a long time. Limit your time in the sun. Avoid tanning||
5326|121|P|booths and sunlamps. Use sunscreen and wear protective clothing||
5326|122|P|when outdoors. Tell your doctor right away if you get sunburned||
5326|123|P|or have skin blisters/redness, or notice new or changed||
5326|124|P|moles/skin lesions.||
5326|125|P|   Before having surgery, tell your doctor or dentist about all||
5326|126|P|the products you use (including prescription drugs,||
5326|127|P|nonprescription drugs, and herbal products).||
5326|128|P|   Older adults may be more sensitive to the side effects of this||
5326|129|P|drug, especially QT prolongation (see above).||
5326|130|P|   Children may be at greater risk for liver problems and being||
5326|131|P|more sensitive to the sun while using this drug (see above).||
5326|132|P|   Tell your doctor if you are pregnant or plan to become||
5326|133|P|pregnant. You should not become pregnant while using||
5326|134|P|voriconazole. Voriconazole may harm an unborn baby. Ask about||
5326|135|P|reliable forms of birth control while using this medication. If||
5326|136|P|you become pregnant, talk to your doctor right away about the||
5326|137|P|risks and benefits of this medication.||
5326|138|P|   It is unknown if this medication passes into breast milk.||
5326|139|P|Because of the possible risk to the infant, breastfeeding is not||
5326|140|P|recommended while using this medication. Consult your doctor||
5326|141|P|before breastfeeding.||
5326|142|B|||
5326|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5326|144|I|medications work or increase your risk for serious side effects.||
5326|145|I|This document does not contain all possible drug interactions.||
5326|146|I|Keep a list of all the products you use (including||
5326|147|I|prescription/nonprescription drugs and herbal products) and share||
5326|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
5326|149|I|the dosage of any medicines without your doctor's approval.||
5326|150|I|   Voriconazole can slow down the removal of other medications||
5326|151|I|from your body, which may affect how they work. Examples of||
5326|152|I|affected drugs include eletriptan, ergot alkaloids (such as||
5326|153|I|dihydroergotamine, ergotamine), certain drugs to treat irregular||
5326|154|I|heartbeat (such disopyramide, dronedarone, quinidine),||
5326|155|I|ivabradine, lurasidone, naloxegol, pimozide, ranolazine,||
5326|156|I|sirolimus, certain "statin" cholesterol drugs (such as||
5326|157|I|lovastatin, simvastatin), tolvaptan, among others.||
5326|158|I|   Other medications can affect the removal of voriconazole from||
5326|159|I|your body, which may affect how voriconazole works. Examples||
5326|160|I|include butalbital, efavirenz, mitotane, rifamycins (such as||
5326|161|I|rifabutin, rifampin), ritonavir, secobarbital, certain drugs used||
5326|162|I|to treat seizures (such as carbamazepine, phenobarbital), St.||
5326|163|I|John's wort, among others.||
5326|164|I|   Many drugs besides voriconazole may affect the heart rhythm||
5326|165|I|(QT prolongation), including pacritinib, among others.||
5326|166|B|||
5326|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5326|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5326|169|O|poison control center right away. US residents can call||
5326|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5326|171|B|||
5326|172|N|NOTES:  Do not share this medication with others.||
5326|173|N|   This medication has been prescribed for your current condition||
5326|174|N|only. Do not use it later for another infection unless your||
5326|175|N|doctor tells you to.||
5326|176|N|   Lab and/or medical tests (such as liver/kidney function, blood||
5326|177|N|mineral levels) should be done before you start taking this||
5326|178|N|medication and while you are taking it. Keep all medical and lab||
5326|179|N|appointments. Consult your doctor for more details.||
5326|180|B|||
5326|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5326|182|D|remember. If it is near the time of the next dose, skip the||
5326|183|D|missed dose. Take your next dose at the regular time. Do not||
5326|184|D|double the dose to catch up.||
5326|185|B|||
5326|186|R|STORAGE:  Store at room temperature away from light and moisture.||
5326|187|R|Do not store in the bathroom. Keep all medications away from||
5326|188|R|children and pets.||
5326|189|R|   Do not flush medications down the toilet or pour them into a||
5326|190|R|drain unless instructed to do so. Properly discard this product||
5326|191|R|when it is expired or no longer needed. Consult your pharmacist||
5326|192|R|or local waste disposal company.||
5326|193|B|||
5326|194|A|Information last revised April 2025.||
5326|195|A|Copyright(c) 2025 First Databank, Inc.||
5326|196|B|||
5330|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5330|002|Z|does NOT have all possible information about this product. This||
5330|003|Z|information does not assure that this product is safe, effective,||
5330|004|Z|or appropriate for you. This information is not individual||
5330|005|Z|medical advice and does not substitute for the advice of your||
5330|006|Z|health care professional. Always ask your health care||
5330|007|Z|professional for complete information about this product and your||
5330|008|Z|specific health needs.||
5330|009|B|||
5330|010|T|ADEFOVIR DIPIVOXIL - ORAL||
5330|011|F|(a-DEF-oh-vir DYE-piv-OX-il)||
5330|012|B|||
5330|013|C|COMMON BRAND NAME(S): Hepsera||
5330|014|B|||
5330|015|W|WARNING:  Severe worsening of hepatitis (rarely including death)||
5330|016|W|has occurred when treatment with adefovir dipivoxil is stopped.||
5330|017|W|When you are instructed to stop taking this medication, your||
5330|018|W|doctor will monitor you closely for signs of worsening hepatitis.||
5330|019|W|If you are instructed to stop taking this medication, be sure to||
5330|020|W|keep all doctor and lab appointments after you stop taking this||
5330|021|W|drug.||
5330|022|W|   Rarely, severe (sometimes fatal) liver and blood acid-base||
5330|023|W|balance problems (lactic acidosis) have occurred in patients||
5330|024|W|(especially if overweight) while using similar types of||
5330|025|W|medication (nucleoside analogs such as didanosine or stavudine).||
5330|026|W|Tell your doctor right away if you have unusual||
5330|027|W|weakness/tiredness, dark urine, yellowing eyes/skin,||
5330|028|W|stomach/abdominal pain, drowsiness, muscle aches/weakness,||
5330|029|W|fast/difficult breathing, or fast/irregular heartbeat.||
5330|030|W|   In patients with kidney disease, adefovir dipivoxil can cause||
5330|031|W|kidney problems. Tell your doctor right away if you develop signs||
5330|032|W|of kidney problems such as a change in the amount of urine.||
5330|033|W|   If you get or have HIV infection that is not being treated||
5330|034|W|with medication, adefovir dipivoxil may cause your HIV infection||
5330|035|W|to become untreatable with the usual HIV drugs (development of||
5330|036|W|HIV resistance). Talk to your doctor or pharmacist for more||
5330|037|W|details.||
5330|038|B|||
5330|039|U|USES:  This medication is used to treat a chronic viral infection||
5330|040|U|of the liver (hepatitis B). It works by slowing the growth of the||
5330|041|U|virus, helping to lower the amount of virus in your body. It is||
5330|042|U|not a cure for hepatitis B and does not prevent the passing of||
5330|043|U|hepatitis B to others.||
5330|044|U|   This medication is a nucleotide analog.||
5330|045|B|||
5330|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5330|047|H|from your pharmacist before you start taking adefovir and each||
5330|048|H|time you get a refill. If you have any questions, ask your doctor||
5330|049|H|or pharmacist.||
5330|050|H|   Take this medication by mouth with or without food as directed||
5330|051|H|by your doctor, usually once daily. The dosage is based on your||
5330|052|H|medical condition and response to treatment.||
5330|053|H|   Use this medication regularly to the get the most benefit from||
5330|054|H|it. To help you remember, take it at the same time each day. Do||
5330|055|H|not increase or decrease your dose or stop taking this medication||
5330|056|H|unless directed to do so by your doctor or pharmacist. Refill||
5330|057|H|your medication before it runs out.||
5330|058|H|   Treatment with adefovir alone is not appropriate for patients||
5330|059|H|infected with both hepatitis B and HIV. An HIV test is||
5330|060|H|recommended both before and during treatment to ensure you||
5330|061|H|receive appropriate treatment. Consult your doctor or pharmacist||
5330|062|H|for more information.||
5330|063|H|   Worsening of your condition, decreased response to treatment,||
5330|064|H|or infection by resistant strains of the virus may occur during||
5330|065|H|or after treatment. Tell your doctor right away of any new||
5330|066|H|symptoms that occur during or after treatment.||
5330|067|B|||
5330|068|S|SIDE EFFECTS:  See also Warning section.||
5330|069|S|   Weakness, headache, fever, increased cough, nausea, vomiting,||
5330|070|S|diarrhea, or gas may occur. If any of these effects last or get||
5330|071|S|worse, tell your doctor or pharmacist promptly.||
5330|072|S|   Remember that this medication has been prescribed because your||
5330|073|S|doctor has judged that the benefit to you is greater than the||
5330|074|S|risk of side effects. Many people using this medication do not||
5330|075|S|have serious side effects.||
5330|076|S|   Tell your doctor right away if you have any serious side||
5330|077|S|effects, including: signs of kidney problems (such as change in||
5330|078|S|the amount of urine).||
5330|079|S|   A very serious allergic reaction to this drug is rare.||
5330|080|S|However, get medical help right away if you notice any symptoms||
5330|081|S|of a serious allergic reaction, including: rash, itching/swelling||
5330|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5330|083|S|breathing.||
5330|084|S|   This is not a complete list of possible side effects. If you||
5330|085|S|notice other effects not listed above, contact your doctor or||
5330|086|S|pharmacist.||
5330|087|S|   In the US -||
5330|088|S|   Call your doctor for medical advice about side effects. You||
5330|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5330|090|S|www.fda.gov/medwatch.||
5330|091|S|   In Canada - Call your doctor for medical advice about side||
5330|092|S|effects. You may report side effects to Health Canada at||
5330|093|S|1-866-234-2345.||
5330|094|B|||
5330|095|P|PRECAUTIONS:  Before taking adefovir, tell your doctor or||
5330|096|P|pharmacist if you are allergic to it; or if you have any other||
5330|097|P|allergies. This product may contain inactive ingredients, which||
5330|098|P|can cause allergic reactions or other problems. Talk to your||
5330|099|P|pharmacist for more details.||
5330|100|P|   Before using this medication, tell your doctor or pharmacist||
5330|101|P|your medical history, especially of: HIV infection, kidney||
5330|102|P|problems, liver transplant.||
5330|103|P|   Before having surgery, tell your doctor or dentist about all||
5330|104|P|the products you use (including prescription drugs,||
5330|105|P|nonprescription drugs, and herbal products).||
5330|106|P|   During pregnancy, this medication should be used only when||
5330|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
5330|108|P|   It is unknown if this medication passes into breast milk.||
5330|109|P|Consult your doctor before breastfeeding.||
5330|110|B|||
5330|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5330|112|I|medications work or increase your risk for serious side effects.||
5330|113|I|This document does not contain all possible drug interactions.||
5330|114|I|Keep a list of all the products you use (including||
5330|115|I|prescription/nonprescription drugs and herbal products) and share||
5330|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
5330|117|I|the dosage of any medicines without your doctor's approval.||
5330|118|I|   A product that may interact with this drug is: cidofovir.||
5330|119|I|   Do not take products that contain tenofovir with this||
5330|120|I|medication.||
5330|121|B|||
5330|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5330|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5330|124|O|poison control center right away. US residents can call||
5330|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5330|126|B|||
5330|127|N|NOTES:  Do not share this medication with others.||
5330|128|N|   To avoid spreading hepatitis B to others, practice "safer sex"||
5330|129|N|and always use an effective barrier method (such as latex||
5330|130|N|condoms/dental dams) during sexual activity. Do not share||
5330|131|N|needles. Talk to your doctor or pharmacist for more details.||
5330|132|N|   Lab and/or medical tests (such as kidney/liver function, HIV||
5330|133|N|tests) may be done while you are taking this medication. Keep all||
5330|134|N|lab and medical appointments during and for several months after||
5330|135|N|treatment. Consult your doctor for more details.||
5330|136|B|||
5330|137|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5330|138|D|If it is near the time of the next dose, skip the missed dose.||
5330|139|D|Take your next dose at the regular time. Do not double the dose||
5330|140|D|to catch up.||
5330|141|B|||
5330|142|R|STORAGE:  Store in the original container at room temperature||
5330|143|R|away from light and moisture. Do not store in the bathroom. Keep||
5330|144|R|all medications away from children and pets.||
5330|145|R|   Do not flush medications down the toilet or pour them into a||
5330|146|R|drain unless instructed to do so. Properly discard this product||
5330|147|R|when it is expired or no longer needed. Consult your pharmacist||
5330|148|R|or local waste disposal company.||
5330|149|B|||
5330|150|A|Information last revised May 2024.||
5330|151|A|Copyright(c) 2025 First Databank, Inc.||
5330|152|B|||
5333|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5333|002|Z|does NOT have all possible information about this product. This||
5333|003|Z|information does not assure that this product is safe, effective,||
5333|004|Z|or appropriate for you. This information is not individual||
5333|005|Z|medical advice and does not substitute for the advice of your||
5333|006|Z|health care professional. Always ask your health care||
5333|007|Z|professional for complete information about this product and your||
5333|008|Z|specific health needs.||
5333|009|B|||
5333|010|T|BUDESONIDE CAPSULE - ORAL||
5333|011|F|(bue-DES-oh-nide)||
5333|012|B|||
5333|013|C|COMMON BRAND NAME(S): Entocort EC, Ortikos||
5333|014|B|||
5333|015|U|USES:  This medication is used to treat a certain bowel condition||
5333|016|U|(Crohn's disease). While budesonide does not cure this condition,||
5333|017|U|it may decrease symptoms such as pain and diarrhea. Budesonide is||
5333|018|U|an anti-inflammatory drug (corticosteroid hormone). It works by||
5333|019|U|decreasing the body's natural defense response (immune response).||
5333|020|B|||
5333|021|V|OTHER USES:  This section contains uses of this drug that are not||
5333|022|V|listed in the approved professional labeling for the drug but||
5333|023|V|that may be prescribed by your health care professional. Use this||
5333|024|V|drug for a condition that is listed in this section only if it||
5333|025|V|has been so prescribed by your health care professional.||
5333|026|V|   This drug may also be used for certain immune system||
5333|027|V|disorders.||
5333|028|B|||
5333|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5333|030|H|from your pharmacist before you start taking budesonide and each||
5333|031|H|time you get a refill. If you have any questions, ask your doctor||
5333|032|H|or pharmacist.||
5333|033|H|   Take this medication by mouth with or without food as directed||
5333|034|H|by your doctor, usually once daily in the morning. Swallow this||
5333|035|H|medication whole with a full glass of water (8 ounces/240||
5333|036|H|milliliters) unless your doctor directs you otherwise. Do not||
5333|037|H|crush or chew the capsules. Doing so can release all of the drug||
5333|038|H|at once, increasing the risk of side effects.||
5333|039|H|   If you have trouble swallowing the capsules whole, certain||
5333|040|H|brands may be opened and the contents sprinkled onto a||
5333|041|H|tablespoonful of soft, cool applesauce in a clean container. Stir||
5333|042|H|and take all of the mixture without chewing. Drink a full glass||
5333|043|H|of cool water (8 ounces/240 milliliters) to make sure you have||
5333|044|H|swallowed all of your dose. Take all of the mixture within 30||
5333|045|H|minutes after preparing it. Do not save the mixture for later||
5333|046|H|use. Ask your pharmacist if you have questions about your||
5333|047|H|particular brand.||
5333|048|H|   The dosage and length of treatment are based on your medical||
5333|049|H|condition, age, and response to treatment.||
5333|050|H|   Avoid eating grapefruit or drinking grapefruit juice while||
5333|051|H|using this medication unless your doctor or pharmacist says you||
5333|052|H|may do so safely. Grapefruit can increase the chance of side||
5333|053|H|effects with this medicine. Ask your doctor or pharmacist for||
5333|054|H|more details.||
5333|055|H|   If you are regularly taking a different corticosteroid by||
5333|056|H|mouth (such as prednisone), you should not stop taking it unless||
5333|057|H|directed by your doctor. Some conditions (such as asthma,||
5333|058|H|allergies) may become worse when the drug is suddenly stopped. If||
5333|059|H|you suddenly stop taking the drug, you may also have withdrawal||
5333|060|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
5333|061|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
5333|062|H|doctor may slowly lower the dose of your old medication after you||
5333|063|H|begin taking budesonide. Tell your doctor or pharmacist right||
5333|064|H|away if you have withdrawal. See also Precautions section.||
5333|065|H|   Use this medication regularly to get the most benefit from it.||
5333|066|H|To help you remember, take it at the same time each day. Do not||
5333|067|H|increase your dose or use this drug more often or for longer than||
5333|068|H|prescribed. Your condition will not improve any faster, and your||
5333|069|H|risk of side effects will increase.||
5333|070|H|   Do not stop taking this medication without consulting your||
5333|071|H|doctor. Some conditions may become worse when this drug is||
5333|072|H|suddenly stopped. Your dose may need to be gradually decreased.||
5333|073|H|   Tell your doctor if your condition does not get better or if||
5333|074|H|it gets worse.||
5333|075|B|||
5333|076|S|SIDE EFFECTS:  This medication usually has fewer side effects||
5333|077|S|than other corticosteroids because budesonide works in the gut||
5333|078|S|and only small amounts are absorbed into the body. Nausea,||
5333|079|S|abdominal pain, or headache may occur. If any of these effects||
5333|080|S|last or get worse, tell your doctor or pharmacist promptly.||
5333|081|S|   Remember that this medication has been prescribed because your||
5333|082|S|doctor has judged that the benefit to you is greater than the||
5333|083|S|risk of side effects. Many people using this medication do not||
5333|084|S|have serious side effects.||
5333|085|S|   Because this drug works by weakening the immune system, it may||
5333|086|S|lower your ability to fight infections. This may make you more||
5333|087|S|likely to get a serious (rarely fatal) infection or make any||
5333|088|S|infection you have worse. Tell your doctor right away if you have||
5333|089|S|any signs of infection (such as sore throat that doesn't go away,||
5333|090|S|fever, chills). This medication may sometimes cause oral thrush||
5333|091|S|or a new yeast infection. Contact your doctor if you notice white||
5333|092|S|patches in your mouth, a change in vaginal discharge, or other||
5333|093|S|new symptoms.||
5333|094|S|   Tell your doctor right away if you have any serious side||
5333|095|S|effects, including: easy bruising/bleeding, puffy face, unusual||
5333|096|S|weight gain, menstrual period changes, mental/mood changes (such||
5333|097|S|as depression, mood swings, agitation), muscle weakness/pain,||
5333|098|S|bone pain, thinning skin, slow wound healing, increased||
5333|099|S|thirst/urination, vision problems, symptoms of stomach/intestinal||
5333|100|S|bleeding (such as stomach/abdominal pain, black/tarry stools,||
5333|101|S|vomit that looks like coffee grounds), red/purple spots on the||
5333|102|S|skin.||
5333|103|S|   A very serious allergic reaction to this drug is rare.||
5333|104|S|However, get medical help right away if you notice any symptoms||
5333|105|S|of a serious allergic reaction, including: rash, itching/swelling||
5333|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5333|107|S|breathing.||
5333|108|S|   This is not a complete list of possible side effects. If you||
5333|109|S|notice other effects not listed above, contact your doctor or||
5333|110|S|pharmacist.||
5333|111|S|   In the US -||
5333|112|S|   Call your doctor for medical advice about side effects. You||
5333|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5333|114|S|www.fda.gov/medwatch.||
5333|115|S|   In Canada - Call your doctor for medical advice about side||
5333|116|S|effects. You may report side effects to Health Canada at||
5333|117|S|1-866-234-2345.||
5333|118|B|||
5333|119|P|PRECAUTIONS:  Before taking budesonide, tell your doctor if you||
5333|120|P|are allergic to it; or if you have any other allergies. This||
5333|121|P|product may contain inactive ingredients, which can cause||
5333|122|P|allergic reactions or other problems. Talk to your pharmacist for||
5333|123|P|more details.||
5333|124|P|   Before using this medication, tell your doctor or pharmacist||
5333|125|P|your medical history, especially of: eye problems (such as||
5333|126|P|cataracts, glaucoma), high blood pressure, liver problems (such||
5333|127|P|as hepatitis B), diabetes, stomach/intestinal problems (such as||
5333|128|P|diverticulitis, ulcer), bone loss (osteoporosis), current/past||
5333|129|P|infections (such as tuberculosis, herpes), bleeding problems,||
5333|130|P|mental/mood problems (such as psychosis, anxiety, depression), a||
5333|131|P|certain adrenal gland tumor (pheochromocytoma).||
5333|132|P|   Using corticosteroid medications for a long time can make it||
5333|133|P|more difficult for your body to respond to physical stress.||
5333|134|P|Before having surgery or emergency treatment, or if you get a||
5333|135|P|serious illness/injury, tell your doctor or dentist that you are||
5333|136|P|using this medication or have used this medication within the||
5333|137|P|past 12 months. Tell your doctor right away if you develop||
5333|138|P|unusual/extreme tiredness or weight loss. If you will be using||
5333|139|P|this medication for a long time, carry a warning card or medical||
5333|140|P|ID bracelet that identifies your use of this medication.||
5333|141|P|   Before having surgery, tell your doctor or dentist about all||
5333|142|P|the products you use (including prescription drugs,||
5333|143|P|nonprescription drugs, and herbal products).||
5333|144|P|   Daily use of alcohol while using this medicine may increase||
5333|145|P|your risk for stomach bleeding. Limit alcoholic beverages.||
5333|146|P|Consult your doctor or pharmacist for more information.||
5333|147|P|   This medication can make you more likely to get infections or||
5333|148|P|may make current infections worse. Stay away from anyone who has||
5333|149|P|an infection that may easily spread (such as chickenpox,||
5333|150|P|COVID-19, measles, flu). Talk to your doctor if you have been||
5333|151|P|exposed to an infection or for more details.||
5333|152|P|   Tell your health care professional that you are using||
5333|153|P|budesonide before having any immunizations/vaccinations. Avoid||
5333|154|P|contact with people who have recently received live vaccines||
5333|155|P|(such as flu vaccine inhaled through the nose).||
5333|156|P|   Older adults may be more sensitive to the side effects of this||
5333|157|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
5333|158|P|mental/mood changes (such as confusion).||
5333|159|P|   This medication may slow down a child's growth if used for a||
5333|160|P|long time. Consult the doctor or pharmacist for more details. See||
5333|161|P|the doctor regularly so your child's height and growth can be||
5333|162|P|checked.||
5333|163|P|   During pregnancy, this medication should be used only when||
5333|164|P|clearly needed. Discuss the risks and benefits with your doctor.||
5333|165|P|Babies born to mothers who have used corticosteroids for a long||
5333|166|P|time may develop hormone problems. Tell your doctor right away if||
5333|167|P|you notice symptoms such as nausea/vomiting that doesn't stop,||
5333|168|P|severe diarrhea, or weakness in your newborn.||
5333|169|P|   This medication passes into breast milk. Consult your doctor||
5333|170|P|before breastfeeding.||
5333|171|B|||
5333|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5333|173|I|medications work or increase your risk for serious side effects.||
5333|174|I|This document does not contain all possible drug interactions.||
5333|175|I|Keep a list of all the products you use (including||
5333|176|I|prescription/nonprescription drugs and herbal products) and share||
5333|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
5333|178|I|the dosage of any medicines without your doctor's approval.||
5333|179|I|   Some products that may interact with this drug are:||
5333|180|I|aldesleukin, desmopressin, mifepristone, drugs that can cause||
5333|181|I|bleeding/bruising (including antiplatelet drugs such as||
5333|182|I|clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs||
5333|183|I|such as aspirin/celecoxib/ibuprofen).||
5333|184|I|   If your doctor has told you to take low-dose aspirin to||
5333|185|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
5333|186|I|you should keep taking the aspirin unless your doctor tells you||
5333|187|I|not to. Ask your doctor or pharmacist for more details.||
5333|188|I|   This product may interfere with certain lab tests (such as||
5333|189|I|skin tests), possibly causing false test results. Make sure lab||
5333|190|I|personnel and all your doctors know you use this drug.||
5333|191|B|||
5333|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5333|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5333|194|O|poison control center right away. US residents can call||
5333|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5333|196|B|||
5333|197|N|NOTES:  Do not share this medication with others.||
5333|198|N|   If this medication is used for a long time, lab and/or medical||
5333|199|N|tests (such as blood count, bone density, eye exams,||
5333|200|N|height/weight measurements) may be done while you are taking it.||
5333|201|N|Keep all medical and lab appointments. Consult your doctor for||
5333|202|N|more details.||
5333|203|N|   This medication may cause bone loss (osteoporosis) when used||
5333|204|N|for a long time. Lifestyle changes that may help reduce the risk||
5333|205|N|of bone problems include doing weight-bearing exercise, stopping||
5333|206|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
5333|207|N|D. Talk to your doctor for more details.||
5333|208|B|||
5333|209|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5333|210|D|remember. If it is near the time of the next dose, skip the||
5333|211|D|missed dose. Take your next dose at the regular time. Do not||
5333|212|D|double the dose to catch up.||
5333|213|B|||
5333|214|R|STORAGE:  Store at room temperature away from light and moisture.||
5333|215|R|Do not store in the bathroom. Keep all medications away from||
5333|216|R|children and pets.||
5333|217|R|   Do not flush medications down the toilet or pour them into a||
5333|218|R|drain unless instructed to do so. Properly discard this product||
5333|219|R|when it is expired or no longer needed. Consult your pharmacist||
5333|220|R|or local waste disposal company.||
5333|221|B|||
5333|222|M|MEDICAL ALERT:  Your condition can cause complications in a||
5333|223|M|medical emergency. For information about enrolling in MedicAlert,||
5333|224|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5333|225|B|||
5333|226|A|Information last revised September 2025.||
5333|227|A|Copyright(c) 2025 First Databank, Inc.||
5333|228|B|||
5341|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5341|002|Z|does NOT have all possible information about this product. This||
5341|003|Z|information does not assure that this product is safe, effective,||
5341|004|Z|or appropriate for you. This information is not individual||
5341|005|Z|medical advice and does not substitute for the advice of your||
5341|006|Z|health care professional. Always ask your health care||
5341|007|Z|professional for complete information about this product and your||
5341|008|Z|specific health needs.||
5341|009|B|||
5341|010|T|LEUPROLIDE 3 MONTH (22.5 MG) - SUBCUTANEOUS INJECTION||
5341|011|F|(LOO-proe-lide)||
5341|012|B|||
5341|013|C|COMMON BRAND NAME(S): Eligard||
5341|014|B|||
5341|015|U|USES:  Leuprolide is used to treat advanced prostate cancer. It||
5341|016|U|is not a cure. Most types of prostate cancer need the hormone||
5341|017|U|testosterone to grow and spread. Leuprolide works by reducing the||
5341|018|U|amount of testosterone that the body makes. This helps slow or||
5341|019|U|stop the growth of cancer cells and helps relieve symptoms such||
5341|020|U|as painful/difficult urination. Talk to your doctor about the||
5341|021|U|risks and benefits of treatment.||
5341|022|B|||
5341|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
5341|024|H|from your pharmacist before you start using leuprolide and each||
5341|025|H|time you get a refill. If you have any questions, ask your doctor||
5341|026|H|or pharmacist.||
5341|027|H|   This medication is given by injection under the skin by a||
5341|028|H|health care professional as directed by your doctor, usually once||
5341|029|H|every 3 months. This product slowly releases the medication into||
5341|030|H|your blood over a 3-month period.||
5341|031|H|   Use this medication regularly to get the most benefit from it.||
5341|032|H|To help you remember, mark your calendar with a reminder.||
5341|033|H|   During the first few weeks of treatment, your hormone levels||
5341|034|H|will actually go up before they go down. This is a normal||
5341|035|H|response to this medication. Your symptoms may get worse for a||
5341|036|H|few weeks. If you have prostate cancer that has spread to the||
5341|037|H|spine or caused urinary blockage, you may require closer||
5341|038|H|monitoring by your doctor, especially when you first start||
5341|039|H|treatment. Tell your doctor right away if you have any bone pain,||
5341|040|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
5341|041|H|painful/difficult urination, unusual weakness, or inability to||
5341|042|H|move.||
5341|043|B|||
5341|044|S|SIDE EFFECTS:  Hot flashes (flushing), increased sweating, night||
5341|045|S|sweats, tiredness, swelling of the ankles/feet, increased||
5341|046|S|urination at night, dizziness, or mild burning/pain/bruising at||
5341|047|S|the injection site may occur. If any of these effects last or get||
5341|048|S|worse, tell your doctor or pharmacist promptly.||
5341|049|S|   Rarely, shrinking of the testicles, breast||
5341|050|S|tenderness/swelling, or reduced sexual interest/ability may also||
5341|051|S|occur as a result of lowered testosterone levels. Talk to your||
5341|052|S|doctor if these effects occur.||
5341|053|S|   Remember that this medication has been prescribed because your||
5341|054|S|doctor has judged that the benefit to you is greater than the||
5341|055|S|risk of side effects. Many people using this medication do not||
5341|056|S|have serious side effects.||
5341|057|S|   Tell your doctor right away if you have any serious side||
5341|058|S|effects, including: new/worsening bone pain, easily broken bones,||
5341|059|S|increased thirst/urination, mental/mood changes (such as||
5341|060|S|depression, thoughts of suicide, mood swings, aggression), signs||
5341|061|S|of liver disease (such as nausea/vomiting that doesn't stop, loss||
5341|062|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
5341|063|S|urine).||
5341|064|S|   Get medical help right away if you have any very serious side||
5341|065|S|effects, including: symptoms of a heart attack (such as||
5341|066|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
5341|067|S|signs of a stroke (such as weakness on one side of the body,||
5341|068|S|trouble speaking, sudden vision changes, confusion), seizures,||
5341|069|S|fast/irregular heartbeat, severe dizziness, fainting.||
5341|070|S|   A very serious allergic reaction to this drug is rare.||
5341|071|S|However, get medical help right away if you notice any symptoms||
5341|072|S|of a serious allergic reaction, including: fever, swollen lymph||
5341|073|S|nodes, rash, itching/swelling (especially of the||
5341|074|S|face/tongue/throat), severe dizziness, trouble breathing.||
5341|075|S|   This is not a complete list of possible side effects. If you||
5341|076|S|notice other effects not listed above, contact your doctor or||
5341|077|S|pharmacist.||
5341|078|S|   In the US -||
5341|079|S|   Call your doctor for medical advice about side effects. You||
5341|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5341|081|S|www.fda.gov/medwatch.||
5341|082|S|   In Canada - Call your doctor for medical advice about side||
5341|083|S|effects. You may report side effects to Health Canada at||
5341|084|S|1-866-234-2345.||
5341|085|B|||
5341|086|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
5341|087|P|pharmacist if you are allergic to it; or to similar drugs (such||
5341|088|P|as histrelin, triptorelin); or if you have any other allergies.||
5341|089|P|This product may contain inactive ingredients, which can cause||
5341|090|P|allergic reactions or other problems. Talk to your pharmacist for||
5341|091|P|more details.||
5341|092|P|   Before using this medication, tell your doctor or pharmacist||
5341|093|P|your medical history, especially of: diabetes, heart disease||
5341|094|P|(such as heart attack), stroke, high cholesterol, mental/mood||
5341|095|P|problems (such as depression), seizures.||
5341|096|P|   Leuprolide may weaken your bones and increase your risk for||
5341|097|P|bone loss (osteoporosis) if used for a long time. Before using||
5341|098|P|this medication, tell your doctor or pharmacist if you have||
5341|099|P|osteoporosis or if you have any of the following risk factors for||
5341|100|P|osteoporosis: long-term alcohol use, smoking, family history of||
5341|101|P|osteoporosis and broken bones, use of certain medications (for||
5341|102|P|example, corticosteroids such as prednisone, certain anti-seizure||
5341|103|P|drugs such as phenytoin).||
5341|104|P|   Leuprolide may cause a condition that affects the heart rhythm||
5341|105|P|(QT prolongation). QT prolongation can rarely cause serious||
5341|106|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
5341|107|P|as severe dizziness, fainting) that need medical attention right||
5341|108|P|away.||
5341|109|P|   The risk of QT prolongation may be increased if you have||
5341|110|P|certain medical conditions or are taking other drugs that may||
5341|111|P|cause QT prolongation. Before using leuprolide, tell your doctor||
5341|112|P|or pharmacist of all the drugs you take and if you have any of||
5341|113|P|the following conditions: certain heart problems (heart failure,||
5341|114|P|slow heartbeat, QT prolongation in the EKG), family history of||
5341|115|P|certain heart problems (QT prolongation in the EKG, sudden||
5341|116|P|cardiac death).||
5341|117|P|   Low levels of potassium or magnesium in the blood may also||
5341|118|P|increase your risk of QT prolongation. This risk may increase if||
5341|119|P|you use certain drugs (such as diuretics/"water pills") or if you||
5341|120|P|have conditions such as severe sweating, diarrhea, or vomiting.||
5341|121|P|Talk to your doctor about using leuprolide safely.||
5341|122|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5341|123|P|can make you more dizzy. Do not drive, use machinery, or do||
5341|124|P|anything that needs alertness until you can do it safely. Limit||
5341|125|P|alcoholic beverages. Talk to your doctor if you are using||
5341|126|P|marijuana (cannabis).||
5341|127|P|   Before having surgery, tell your doctor or dentist about all||
5341|128|P|the products you use (including prescription drugs,||
5341|129|P|nonprescription drugs, and herbal products).||
5341|130|P|   Older adults may be more sensitive to the side effects of this||
5341|131|P|drug, especially QT prolongation (see above).||
5341|132|P|   This medication can affect fertility in males. Ask your doctor||
5341|133|P|for more details.||
5341|134|P|   This medication must not be used during pregnancy. It may harm||
5341|135|P|an unborn baby. It is important to prevent pregnancy while using||
5341|136|P|this medication. Consult your doctor for more details and to||
5341|137|P|discuss using reliable forms of non-hormonal birth control (such||
5341|138|P|as condoms, diaphragm with spermicide) while using this||
5341|139|P|medication. If you become pregnant or think you may be pregnant,||
5341|140|P|tell your doctor right away.||
5341|141|P|   It is unknown if leuprolide passes into breast milk. Because||
5341|142|P|of the possible risk to the infant, breastfeeding is not||
5341|143|P|recommended while using this medication. Consult your doctor||
5341|144|P|before breastfeeding.||
5341|145|B|||
5341|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5341|147|I|medications work or increase your risk for serious side effects.||
5341|148|I|This document does not contain all possible drug interactions.||
5341|149|I|Keep a list of all the products you use (including||
5341|150|I|prescription/nonprescription drugs and herbal products) and share||
5341|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
5341|152|I|the dosage of any medicines without your doctor's approval.||
5341|153|I|   This medication may interfere with certain lab tests, possibly||
5341|154|I|causing false test results. Make sure lab personnel and all your||
5341|155|I|doctors know you use this drug.||
5341|156|B|||
5341|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5341|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5341|159|O|poison control center right away. US residents can call||
5341|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5341|161|B|||
5341|162|N|NOTES:  Do not share this medication with others.||
5341|163|N|   Lab and/or medical tests (such as blood testosterone level,||
5341|164|N|PSA blood test, blood glucose, cholesterol/triglyceride levels)||
5341|165|N|should be done while you are using this medication. Keep all||
5341|166|N|medical and lab appointments. Consult your doctor for more||
5341|167|N|details.||
5341|168|B|||
5341|169|D|MISSED DOSE:  It is important to get each dose of this medication||
5341|170|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
5341|171|D|right away for a new dosing schedule. Do not double the dose to||
5341|172|D|catch up.||
5341|173|B|||
5341|174|R|STORAGE:  Not applicable. This medication is given in a clinic or||
5341|175|R|doctor's office and will not be stored at home.||
5341|176|B|||
5341|177|A|Information last revised October 2024.||
5341|178|A|Copyright(c) 2025 First Databank, Inc.||
5341|179|B|||
5343|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5343|002|Z|does NOT have all possible information about this product. This||
5343|003|Z|information does not assure that this product is safe, effective,||
5343|004|Z|or appropriate for you. This information is not individual||
5343|005|Z|medical advice and does not substitute for the advice of your||
5343|006|Z|health care professional. Always ask your health care||
5343|007|Z|professional for complete information about this product and your||
5343|008|Z|specific health needs.||
5343|009|B|||
5343|010|T|HYDROXOCOBALAMIN - INJECTION||
5343|011|F|(hi-drox-oh-coe-BAL-ah-min)||
5343|012|B|||
5343|013|U|USES:  Hydroxocobalamin is a man-made injectable form of vitamin||
5343|014|U|B12 used to treat low levels (deficiency) of this vitamin.||
5343|015|U|Vitamin B12 helps your body use fat and carbohydrates for energy||
5343|016|U|and make new protein. It is also important for normal blood,||
5343|017|U|cells, and nerves. Most people get enough vitamin B12 in their||
5343|018|U|diet, but a deficiency may occur in certain health conditions||
5343|019|U|(such as poor nutrition, stomach/intestinal problems, infection,||
5343|020|U|cancer). Serious vitamin B12 deficiency may result in anemia,||
5343|021|U|stomach problems, and nerve damage.||
5343|022|B|||
5343|023|H|HOW TO USE:  This medication is given by injection into a muscle||
5343|024|H|as directed by your doctor. The dosage is based on your medical||
5343|025|H|condition and response to treatment. Injections may be given||
5343|026|H|daily when you first start treatment. Certain medical conditions||
5343|027|H|(such as pernicious anemia) may require you to continue receiving||
5343|028|H|injections every month.||
5343|029|H|   If you are giving this medication to yourself at home, learn||
5343|030|H|all preparation and usage instructions from your health care||
5343|031|H|professional. Before using, check this product for particles or||
5343|032|H|discoloration. If either is present, do not use the liquid. Learn||
5343|033|H|how to store and discard medical supplies safely.||
5343|034|B|||
5343|035|S|SIDE EFFECTS:  Pain at the injection site, mild diarrhea,||
5343|036|S|itching, or a feeling of swelling all over the body may occur. If||
5343|037|S|any of these effects last or get worse, tell your doctor or||
5343|038|S|pharmacist promptly.||
5343|039|S|   Remember that this medication has been prescribed because your||
5343|040|S|doctor has judged that the benefit to you is greater than the||
5343|041|S|risk of side effects. Many people using this medication do not||
5343|042|S|have serious side effects.||
5343|043|S|   This medication may cause low potassium levels in the blood||
5343|044|S|(hypokalemia). Tell your doctor right away if any of these||
5343|045|S|serious side effects occur: muscle cramps, weakness, irregular||
5343|046|S|heartbeat.||
5343|047|S|   People who have a rare blood disorder (polycythemia vera) may||
5343|048|S|rarely have symptoms related to this disorder while taking||
5343|049|S|hydroxocobalamin. Get medical help right away if any of these||
5343|050|S|very serious symptoms occur: chest pain (especially with||
5343|051|S|shortness of breath), weakness on one side of the body, sudden||
5343|052|S|vision changes, trouble speaking.||
5343|053|S|   A very serious allergic reaction to this drug is rare.||
5343|054|S|However, get medical help right away if you notice any symptoms||
5343|055|S|of a serious allergic reaction, including: rash, itching/swelling||
5343|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5343|057|S|breathing.||
5343|058|S|   This is not a complete list of possible side effects. If you||
5343|059|S|notice other effects not listed above, contact your doctor or||
5343|060|S|pharmacist.||
5343|061|S|   In the US -||
5343|062|S|   Call your doctor for medical advice about side effects. You||
5343|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5343|064|S|www.fda.gov/medwatch.||
5343|065|S|   In Canada - Call your doctor for medical advice about side||
5343|066|S|effects. You may report side effects to Health Canada at||
5343|067|S|1-866-234-2345.||
5343|068|B|||
5343|069|P|PRECAUTIONS:  Before using hydroxocobalamin, tell your doctor or||
5343|070|P|pharmacist if you are allergic to it; or to cobalt; or if you||
5343|071|P|have any other allergies. This product may contain inactive||
5343|072|P|ingredients, which can cause allergic reactions or other||
5343|073|P|problems. Talk to your pharmacist for more details.||
5343|074|P|   Before using this medication, tell your doctor or pharmacist||
5343|075|P|your medical history, especially of: low potassium blood levels||
5343|076|P|(hypokalemia), gout, a certain blood disorder (polycythemia||
5343|077|P|vera), a certain eye disease (Leber's disease), other||
5343|078|P|vitamin/mineral deficiencies (especially folic acid and iron).||
5343|079|P|   Before having surgery, tell your doctor or dentist about all||
5343|080|P|the products you use (including prescription drugs,||
5343|081|P|nonprescription drugs, and herbal products).||
5343|082|P|   During pregnancy, this medication should be used only when||
5343|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
5343|084|P|   Based on information from related drugs, this medication may||
5343|085|P|pass into breast milk. Consult your doctor before breastfeeding.||
5343|086|B|||
5343|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
5343|088|I|medications work or increase your risk for serious side effects.||
5343|089|I|This document does not contain all possible drug interactions.||
5343|090|I|Keep a list of all the products you use (including||
5343|091|I|prescription/nonprescription drugs and herbal products) and share||
5343|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
5343|093|I|the dosage of any medicines without your doctor's approval.||
5343|094|B|||
5343|095|O|OVERDOSE:  Overdose with this medication is very unlikely.||
5343|096|O|However, if someone has overdosed and has serious symptoms such||
5343|097|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5343|098|O|poison control center right away. US residents can call||
5343|099|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5343|100|B|||
5343|101|N|NOTES:  Do not share this medication with others.||
5343|102|N|   Lab and/or medical tests (such as blood potassium levels,||
5343|103|N|complete blood count, hematocrit, vitamin B12 levels) should be||
5343|104|N|done while you are using this medication. Keep all medical and||
5343|105|N|lab appointments. Consult your doctor for more details.||
5343|106|N|   This product is not a substitute for a proper diet. Remember||
5343|107|N|that it is best to get your vitamins from healthy foods. Vitamin||
5343|108|N|B12 is commonly found in many foods from animals, especially||
5343|109|N|liver, kidney, fish and shellfish, meat, and dairy foods.||
5343|110|B|||
5343|111|D|MISSED DOSE:  It is important to get each dose of this medication||
5343|112|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
5343|113|D|right away for a new dosing schedule. Do not double the dose to||
5343|114|D|catch up.||
5343|115|B|||
5343|116|R|STORAGE:  Consult the product instructions and your pharmacist||
5343|117|R|for storage details. Keep all medications away from children and||
5343|118|R|pets.||
5343|119|R|   Do not flush medications down the toilet or pour them into a||
5343|120|R|drain unless instructed to do so. Properly discard this product||
5343|121|R|when it is expired or no longer needed. Consult your pharmacist||
5343|122|R|or local waste disposal company.||
5343|123|B|||
5343|124|A|Information last revised November 2025.||
5343|125|A|Copyright(c) 2025 First Databank, Inc.||
5343|126|B|||
5352|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5352|002|Z|does NOT have all possible information about this product. This||
5352|003|Z|information does not assure that this product is safe, effective,||
5352|004|Z|or appropriate for you. This information is not individual||
5352|005|Z|medical advice and does not substitute for the advice of your||
5352|006|Z|health care professional. Always ask your health care||
5352|007|Z|professional for complete information about this product and your||
5352|008|Z|specific health needs.||
5352|009|B|||
5352|010|T|OXYCODONE/ACETAMINOPHEN - ORAL||
5352|011|F|(OX-i-KOE-done/a-SEET-a-MIN-oh-fen)||
5352|012|B|||
5352|013|C|COMMON BRAND NAME(S): Percocet||
5352|014|B|||
5352|015|W|WARNING:  Oxycodone/acetaminophen has a risk for abuse and||
5352|016|W|addiction, which can lead to overdose and death.||
5352|017|W|Oxycodone/acetaminophen may also cause severe, possibly fatal,||
5352|018|W|breathing problems. To lower your risk, your doctor should have||
5352|019|W|you take the smallest dose of oxycodone/acetaminophen that works,||
5352|020|W|and take it for the shortest possible time. See also How to Use||
5352|021|W|section for more information about addiction.||
5352|022|W|   Ask your doctor or pharmacist if you should have medication||
5352|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
5352|024|W|Teach your family or household members about the signs of an||
5352|025|W|opioid overdose and how to treat it.||
5352|026|W|   The risk for severe breathing problems is higher when you||
5352|027|W|start this medication and after a dose increase, or if you take||
5352|028|W|the wrong dose/strength. Taking this medication with alcohol or||
5352|029|W|other drugs that can cause drowsiness or breathing problems may||
5352|030|W|cause very serious side effects, including death. Also, other||
5352|031|W|medications can affect the removal of oxycodone/acetaminophen||
5352|032|W|from your body, which may affect how it works. Be sure you know||
5352|033|W|how to take oxycodone/acetaminophen and what other drugs you||
5352|034|W|should avoid taking with it. See also Drug Interactions section.||
5352|035|W|Get medical help right away if any of these very serious side||
5352|036|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
5352|037|W|severe drowsiness/dizziness, difficulty waking up.||
5352|038|W|   Keep this medicine in a safe place to prevent theft, misuse,||
5352|039|W|or abuse. If someone accidentally swallows this drug, get medical||
5352|040|W|help right away.||
5352|041|W|   One ingredient in this product is acetaminophen. Taking too||
5352|042|W|much acetaminophen may cause serious (possibly fatal) liver||
5352|043|W|disease. Adults should not take more than 4000 milligrams (4||
5352|044|W|grams) of acetaminophen a day. People with liver problems and||
5352|045|W|children should take less acetaminophen. Ask your doctor or||
5352|046|W|pharmacist how much acetaminophen is safe to take.||
5352|047|W|   Do not use with any other drug containing acetaminophen||
5352|048|W|without asking your doctor or pharmacist first. Acetaminophen is||
5352|049|W|in many nonprescription and prescription medications (such as||
5352|050|W|pain/fever drugs or cough-and-cold products). Check the labels on||
5352|051|W|all your medicines to see if they contain acetaminophen, and ask||
5352|052|W|your pharmacist if you are unsure.||
5352|053|W|   Get medical help right away if you take too much acetaminophen||
5352|054|W|(overdose), even if you feel well. Overdose symptoms may include||
5352|055|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
5352|056|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
5352|057|W|   Daily alcohol use, especially when combined with||
5352|058|W|acetaminophen, may damage your liver. Avoid alcohol.||
5352|059|W|   Before using this medication, women of childbearing age should||
5352|060|W|talk with their doctor(s) about the risks and benefits. Tell your||
5352|061|W|doctor if you are pregnant or if you plan to become pregnant.||
5352|062|W|During pregnancy, this medication should be used only when||
5352|063|W|clearly needed. It may slightly increase the risk of birth||
5352|064|W|defects if used during the first two months of pregnancy. Also,||
5352|065|W|using it for a long time or in high doses near the expected||
5352|066|W|delivery date may harm the unborn baby. To lessen the risk, take||
5352|067|W|the smallest effective dose for the shortest possible time.||
5352|068|W|Babies born to mothers who use this drug for a long time may||
5352|069|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
5352|070|W|doctor right away if you notice any symptoms in your newborn baby||
5352|071|W|such as crying that doesn't stop, slow/shallow breathing,||
5352|072|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
5352|073|W|difficulty gaining weight.||
5352|074|B|||
5352|075|U|USES:  This combination medication is used to help relieve||
5352|076|U|moderate to severe pain. It contains an opioid pain reliever||
5352|077|U|(oxycodone) and a non-opioid pain reliever (acetaminophen).||
5352|078|U|Oxycodone works in the brain to change how your body feels and||
5352|079|U|responds to pain. Acetaminophen can also reduce a fever.||
5352|080|B|||
5352|081|H|HOW TO USE:  See also Warning section.||
5352|082|H|   Read the Medication Guide provided by your pharmacist before||
5352|083|H|you start taking oxycodone/acetaminophen and each time you get a||
5352|084|H|refill. If you have any questions, ask your doctor or pharmacist.||
5352|085|H|   Take this medication by mouth as directed by your doctor. You||
5352|086|H|may take this drug with or without food. If you have nausea, it||
5352|087|H|may help to take this drug with food. Ask your doctor or||
5352|088|H|pharmacist about other ways to decrease nausea (such as lying||
5352|089|H|down for 1 to 2 hours with as little head movement as possible).||
5352|090|H|   Avoid eating grapefruit or drinking grapefruit juice while||
5352|091|H|using this medication unless your doctor or pharmacist says you||
5352|092|H|may do so safely. Grapefruit can increase the chance of side||
5352|093|H|effects with this medicine. Ask your doctor or pharmacist for||
5352|094|H|more details.||
5352|095|H|   If you are using a liquid form of this medication, use a||
5352|096|H|medication measuring device to carefully measure the prescribed||
5352|097|H|dose. Do not use a household spoon because you may not get the||
5352|098|H|correct dose.||
5352|099|H|   The dosage is based on your medical condition and response to||
5352|100|H|treatment. Do not increase your dose, take the medication more||
5352|101|H|often, or take it for a longer time than prescribed. Properly||
5352|102|H|stop the medication when so directed.||
5352|103|H|   Pain medications work best if they are used as the first signs||
5352|104|H|of pain occur. If you wait until the pain has worsened, the||
5352|105|H|medication may not work as well.||
5352|106|H|   If you have ongoing pain (such as due to cancer), your doctor||
5352|107|H|may direct you to also take long-acting opioid medications. In||
5352|108|H|that case, this medication might be used for sudden||
5352|109|H|(breakthrough) pain only as needed. Other pain relievers (such as||
5352|110|H|ibuprofen, naproxen) may also be prescribed with this medication.||
5352|111|H|Ask your doctor or pharmacist about using oxycodone safely with||
5352|112|H|other drugs.||
5352|113|H|   Suddenly stopping this medication may cause withdrawal,||
5352|114|H|especially if you have used it for a long time or in high doses.||
5352|115|H|To prevent withdrawal, your doctor may lower your dose slowly.||
5352|116|H|Tell your doctor or pharmacist right away if you have any||
5352|117|H|withdrawal symptoms such as restlessness, mental/mood changes||
5352|118|H|(including anxiety, trouble sleeping, thoughts of suicide),||
5352|119|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
5352|120|H|aches, or sudden changes in behavior.||
5352|121|H|   When this medication is used for a long time, it may not work||
5352|122|H|as well. Talk with your doctor if this medication stops working||
5352|123|H|well.||
5352|124|H|   Though it helps many people, this medication may sometimes||
5352|125|H|cause addiction. This risk may be higher if you have a||
5352|126|H|mental/mood disorder or a substance use disorder (such as overuse||
5352|127|H|of or addiction to drugs/alcohol). Take this medication exactly||
5352|128|H|as prescribed to lower the risk of addiction. Ask your doctor or||
5352|129|H|pharmacist for more details.||
5352|130|H|   Tell your doctor if your pain does not get better or if it||
5352|131|H|gets worse, or if you have any new pain.||
5352|132|B|||
5352|133|S|SIDE EFFECTS:  See also Warning section.||
5352|134|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
5352|135|S|drowsiness may occur. Some of these side effects may decrease||
5352|136|S|after you have been using this medication for a while. If any of||
5352|137|S|these effects last or get worse, tell your doctor or pharmacist||
5352|138|S|promptly.||
5352|139|S|   To prevent constipation, eat dietary fiber, drink enough||
5352|140|S|water, and exercise. You may also need to take a laxative. Ask||
5352|141|S|your pharmacist which type of laxative is right for you.||
5352|142|S|   To reduce the risk of dizziness and lightheadedness, get up||
5352|143|S|slowly when rising from a sitting or lying position.||
5352|144|S|   Remember that this medication has been prescribed because your||
5352|145|S|doctor has judged that the benefit to you is greater than the||
5352|146|S|risk of side effects. Many people using this medication do not||
5352|147|S|have serious side effects.||
5352|148|S|   Tell your doctor right away if you have any serious side||
5352|149|S|effects, including: interrupted breathing during sleep (sleep||
5352|150|S|apnea), mental/mood changes, severe stomach/abdominal pain,||
5352|151|S|difficulty urinating, signs of your adrenal glands not working||
5352|152|S|well (such as loss of appetite, unusual tiredness, weight loss),||
5352|153|S|trouble swallowing.||
5352|154|S|   Get medical help right away if you have any very serious side||
5352|155|S|effects, including: fainting, seizure, slow/shallow breathing,||
5352|156|S|severe drowsiness/difficulty waking up.||
5352|157|S|   A very serious allergic reaction to this drug is rare.||
5352|158|S|However, get medical help right away if you notice any symptoms||
5352|159|S|of a serious allergic reaction, including: rash, itching/swelling||
5352|160|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5352|161|S|breathing.||
5352|162|S|   This is not a complete list of possible side effects. If you||
5352|163|S|notice other effects not listed above, contact your doctor or||
5352|164|S|pharmacist.||
5352|165|S|   In the US -||
5352|166|S|   Call your doctor for medical advice about side effects. You||
5352|167|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5352|168|S|www.fda.gov/medwatch.||
5352|169|S|   In Canada - Call your doctor for medical advice about side||
5352|170|S|effects. You may report side effects to Health Canada at||
5352|171|S|1-866-234-2345.||
5352|172|B|||
5352|173|P|PRECAUTIONS:  See also Warning section.||
5352|174|P|   Before taking this medication, tell your doctor or pharmacist||
5352|175|P|if you are allergic to it; or to other opioids (such as morphine,||
5352|176|P|codeine, oxymorphone); or if you have any other allergies. This||
5352|177|P|product may contain inactive ingredients, which can cause||
5352|178|P|allergic reactions or other problems. Talk to your pharmacist for||
5352|179|P|more details.||
5352|180|P|   Before using this medication, tell your doctor or pharmacist||
5352|181|P|your medical history, especially of: brain disorders (such as||
5352|182|P|head injury, tumor, seizures), breathing problems (such as||
5352|183|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
5352|184|P|kidney disease, liver disease, mental/mood disorders (such as||
5352|185|P|confusion, depression), personal or family history of a substance||
5352|186|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
5352|187|P|stomach/intestinal problems (such as blockage, constipation,||
5352|188|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
5352|189|P|(such as due to enlarged prostate), gallbladder disease, disease||
5352|190|P|of the pancreas (pancreatitis).||
5352|191|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
5352|192|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
5352|193|P|machinery, or do anything that needs alertness until you can do||
5352|194|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
5352|195|P|are using marijuana (cannabis).||
5352|196|P|   Liquid products may contain sugar, aspartame, and/or alcohol.||
5352|197|P|Caution is advised if you have diabetes, alcohol dependence,||
5352|198|P|liver disease, phenylketonuria (PKU), or any other condition that||
5352|199|P|requires you to limit/avoid these substances in your diet. Ask||
5352|200|P|your doctor or pharmacist about using this product safely.||
5352|201|P|   Before having surgery, tell your doctor or dentist about all||
5352|202|P|the products you use (including prescription drugs,||
5352|203|P|nonprescription drugs, and herbal products).||
5352|204|P|   Older adults may be more sensitive to the side effects of this||
5352|205|P|drug, especially confusion, dizziness, drowsiness, and||
5352|206|P|slow/shallow breathing.||
5352|207|P|   During pregnancy, this medication should be used only when||
5352|208|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
5352|209|P|benefits with your doctor.||
5352|210|P|   This medication passes into breast milk and may have||
5352|211|P|undesirable effects on a nursing infant. Tell the doctor right||
5352|212|P|away if your baby develops unusual sleepiness, difficulty||
5352|213|P|feeding, or trouble breathing. Consult your doctor before||
5352|214|P|breastfeeding.||
5352|215|B|||
5352|216|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
5352|217|I|   Drug interactions may change how your medications work or||
5352|218|I|increase your risk for serious side effects. This document does||
5352|219|I|not contain all possible drug interactions. Keep a list of all||
5352|220|I|the products you use (including prescription/nonprescription||
5352|221|I|drugs and herbal products) and share it with your doctor and||
5352|222|I|pharmacist. Do not start, stop, or change the dosage of any||
5352|223|I|medicines without your doctor's approval.||
5352|224|I|   Some products that may interact with this drug are: certain||
5352|225|I|pain medications (mixed opioid agonist/antagonists such as||
5352|226|I|butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.||
5352|227|I|   The risk of serious side effects (such as slow/shallow||
5352|228|I|breathing, severe drowsiness/dizziness) may be increased if this||
5352|229|I|medication is taken with other products that may also cause||
5352|230|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5352|231|I|if you are taking other products such as other opioid pain or||
5352|232|I|cough relievers (such as codeine, hydrocodone), alcohol,||
5352|233|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
5352|234|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
5352|235|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
5352|236|I|cetirizine, diphenhydramine).||
5352|237|I|   Check the labels on all your medicines (such as allergy or||
5352|238|I|cough-and-cold products) because they may contain ingredients||
5352|239|I|that cause drowsiness. Ask your pharmacist about using those||
5352|240|I|products safely.||
5352|241|I|   Other medications can affect the removal of||
5352|242|I|oxycodone/acetaminophen from your body, which may affect how it||
5352|243|I|works. Examples include azole antifungals (such as ketoconazole),||
5352|244|I|macrolide antibiotics (such as erythromycin), levoketoconazole,||
5352|245|I|mifepristone, HIV medications (such as tipranavir), rifamycins||
5352|246|I|(such as rifabutin, rifampin), ritonavir, certain drugs used to||
5352|247|I|treat seizures (such as carbamazepine, phenytoin), among others.||
5352|248|I|   This medication may interfere with certain lab tests (such as||
5352|249|I|amylase/lipase levels), possibly causing false test results. Make||
5352|250|I|sure lab personnel and all your doctors know you use this drug.||
5352|251|B|||
5352|252|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5352|253|O|as passing out or trouble breathing, give them naloxone or||
5352|254|O|nalmefene if available, then call 911. If the person is awake and||
5352|255|O|has no symptoms, call a poison control center right away. US||
5352|256|O|residents can call 1-800-222-1222. Canada residents can call||
5352|257|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
5352|258|O|breathing, slow heartbeat, coma, nausea, vomiting, loss of||
5352|259|O|appetite, sweating, stomach/abdominal pain, extreme tiredness,||
5352|260|O|yellowing eyes/skin, dark urine.||
5352|261|B|||
5352|262|N|NOTES:  Do not share this medication with others. Sharing it is||
5352|263|N|against the law.||
5352|264|N|   This medication has been prescribed for your current condition||
5352|265|N|only. Do not use it later for another condition unless your||
5352|266|N|doctor directs you to do so. A different medication may be||
5352|267|N|necessary in that case.||
5352|268|B|||
5352|269|D|MISSED DOSE:  If you are taking this product on a regular||
5352|270|D|schedule and miss a dose, take it as soon as you remember. If it||
5352|271|D|is near the time of the next dose, skip the missed dose. Take||
5352|272|D|your next dose at the regular time. Do not double the dose to||
5352|273|D|catch up.||
5352|274|B|||
5352|275|R|STORAGE:  Store at room temperature away from light and moisture.||
5352|276|R|Different brands of this medication have different storage needs.||
5352|277|R|Check the product package for instructions on how to store your||
5352|278|R|brand, or ask your pharmacist. Keep all medications away from||
5352|279|R|children and pets.||
5352|280|R|   Do not flush medications down the toilet or pour them into a||
5352|281|R|drain unless instructed to do so. Properly discard this product||
5352|282|R|when it is expired or no longer needed. For more details, read||
5352|283|R|the Medication Guide, or consult your pharmacist or local waste||
5352|284|R|disposal company.||
5352|285|B|||
5352|286|A|Information last revised August 2025.||
5352|287|A|Copyright(c) 2025 First Databank, Inc.||
5352|288|B|||
5353|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5353|002|Z|does NOT have all possible information about this product. This||
5353|003|Z|information does not assure that this product is safe, effective,||
5353|004|Z|or appropriate for you. This information is not individual||
5353|005|Z|medical advice and does not substitute for the advice of your||
5353|006|Z|health care professional. Always ask your health care||
5353|007|Z|professional for complete information about this product and your||
5353|008|Z|specific health needs.||
5353|009|B|||
5353|010|T|ATENOLOL - ORAL||
5353|011|F|(a-TEN-oh-lol)||
5353|012|B|||
5353|013|C|COMMON BRAND NAME(S): Tenormin||
5353|014|B|||
5353|015|W|WARNING:  Do not stop taking this medication without consulting||
5353|016|W|your doctor. Some conditions may become worse when you suddenly||
5353|017|W|stop this drug. Some people who have suddenly stopped taking||
5353|018|W|similar drugs have had chest pain, heart attack, and irregular||
5353|019|W|heartbeat. If your doctor decides you should no longer use this||
5353|020|W|drug, your doctor may direct you to gradually decrease your dose||
5353|021|W|over 1 to 2 weeks.||
5353|022|W|   When gradually stopping this medication, it is recommended||
5353|023|W|that you temporarily limit physical activity to decrease strain||
5353|024|W|on the heart. Get medical help right away if you develop chest||
5353|025|W|pain/tightness/pressure, chest pain spreading to the||
5353|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
5353|027|W|fast/irregular heartbeat.||
5353|028|B|||
5353|029|U|USES:  Atenolol is used with or without other medications to||
5353|030|U|treat high blood pressure (hypertension). Lowering high blood||
5353|031|U|pressure helps prevent strokes, heart attacks, and kidney||
5353|032|U|problems. This medication is also used to treat chest pain||
5353|033|U|(angina) and to improve survival after a heart attack.||
5353|034|U|   Atenolol belongs to a class of drugs known as beta blockers.||
5353|035|U|It works by blocking the action of certain natural chemicals in||
5353|036|U|your body, such as epinephrine, on the heart and blood vessels.||
5353|037|U|This effect lowers the heart rate, blood pressure, and strain on||
5353|038|U|the heart.||
5353|039|B|||
5353|040|V|OTHER USES:  This section contains uses of this drug that are not||
5353|041|V|listed in the approved professional labeling for the drug but||
5353|042|V|that may be prescribed by your health care professional. Use this||
5353|043|V|drug for a condition that is listed in this section only if it||
5353|044|V|has been so prescribed by your health care professional.||
5353|045|V|   This drug may also be used for irregular heartbeat or alcohol||
5353|046|V|withdrawal symptoms. It may also be used to reduce the risk of||
5353|047|V|migraine headaches.||
5353|048|B|||
5353|049|H|HOW TO USE:  See also Warning section.||
5353|050|H|   Take this medication by mouth with or without food as directed||
5353|051|H|by your doctor, usually 1 to 2 times daily. The dosage is based||
5353|052|H|on your medical condition and response to treatment.||
5353|053|H|   Apple juice and orange juice may prevent your body from fully||
5353|054|H|absorbing atenolol. It is best to avoid drinking apple/orange||
5353|055|H|juice within 4 hours of taking atenolol, unless your doctor or||
5353|056|H|pharmacist tells you otherwise.||
5353|057|H|   Use this medication regularly in order to get the most benefit||
5353|058|H|from it. To help you remember, take it at the same time(s) each||
5353|059|H|day. Keep taking this medication even if you feel well. Most||
5353|060|H|people with high blood pressure do not feel sick.||
5353|061|H|   If this product is used for chest pain, it must be taken||
5353|062|H|regularly to be effective. It should not be used to treat chest||
5353|063|H|pain when it occurs. Use other medications (such as nitroglycerin||
5353|064|H|placed under the tongue) to relieve chest pain as directed by||
5353|065|H|your doctor.||
5353|066|H|   It may take 1 to 2 weeks before you get the full benefit of||
5353|067|H|this medication. Tell your doctor if your condition does not get||
5353|068|H|better or if it gets worse (for example, your blood pressure||
5353|069|H|readings remain high or increase, your chest pain occurs more||
5353|070|H|often).||
5353|071|B|||
5353|072|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
5353|073|S|   Dizziness, lightheadedness, tiredness, and nausea may occur.||
5353|074|S|If any of these effects last or get worse, tell your doctor or||
5353|075|S|pharmacist promptly.||
5353|076|S|   To reduce the risk of dizziness and lightheadedness, get up||
5353|077|S|slowly when rising from a sitting or lying position.||
5353|078|S|   This drug may reduce blood flow to your hands and feet,||
5353|079|S|causing them to feel cold. Smoking may worsen this effect. Dress||
5353|080|S|warmly and avoid tobacco use.||
5353|081|S|   Remember that this medication has been prescribed because your||
5353|082|S|doctor has judged that the benefit to you is greater than the||
5353|083|S|risk of side effects. Many people using this medication do not||
5353|084|S|have serious side effects.||
5353|085|S|   Tell your doctor right away if you have any serious side||
5353|086|S|effects, including: new or worsening symptoms of heart failure||
5353|087|S|(such as shortness of breath, swelling ankles/feet, unusual||
5353|088|S|tiredness, unusual/sudden weight gain), very slow heartbeat,||
5353|089|S|fainting, blue fingers/toes, mental/mood changes (such as||
5353|090|S|confusion, mood swings, depression).||
5353|091|S|   A very serious allergic reaction to this drug is rare.||
5353|092|S|However, get medical help right away if you notice any symptoms||
5353|093|S|of a serious allergic reaction, including: rash, itching/swelling||
5353|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5353|095|S|breathing.||
5353|096|S|   This is not a complete list of possible side effects. If you||
5353|097|S|notice other effects not listed above, contact your doctor or||
5353|098|S|pharmacist.||
5353|099|S|   In the US -||
5353|100|S|   Call your doctor for medical advice about side effects. You||
5353|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5353|102|S|www.fda.gov/medwatch.||
5353|103|S|   In Canada - Call your doctor for medical advice about side||
5353|104|S|effects. You may report side effects to Health Canada at||
5353|105|S|1-866-234-2345.||
5353|106|B|||
5353|107|P|PRECAUTIONS:  Before taking atenolol, tell your doctor or||
5353|108|P|pharmacist if you are allergic to it; or if you have any other||
5353|109|P|allergies. This product may contain inactive ingredients, which||
5353|110|P|can cause allergic reactions or other problems. Talk to your||
5353|111|P|pharmacist for more details.||
5353|112|P|   Before using this medication, tell your doctor or pharmacist||
5353|113|P|your medical history, especially of: certain types of heart||
5353|114|P|rhythm problems (such as slow heartbeat, second- or third-degree||
5353|115|P|atrioventricular block), breathing problems (such as asthma,||
5353|116|P|chronic bronchitis, emphysema), blood circulation problems (such||
5353|117|P|as Raynaud's disease, peripheral vascular disease), kidney||
5353|118|P|disease, heart failure, serious allergic reactions including||
5353|119|P|those needing treatment with epinephrine, a certain muscle||
5353|120|P|disease (myasthenia gravis).||
5353|121|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5353|122|P|can make you more dizzy. Do not drive, use machinery, or do||
5353|123|P|anything that needs alertness until you can do it safely. Limit||
5353|124|P|alcoholic beverages. Talk to your doctor if you are using||
5353|125|P|marijuana (cannabis).||
5353|126|P|   Before having surgery, tell your doctor or dentist about all||
5353|127|P|the products you use (including prescription drugs,||
5353|128|P|nonprescription drugs, and herbal products).||
5353|129|P|   This product may prevent the fast/pounding heartbeat you would||
5353|130|P|usually feel when your blood sugar level falls too low||
5353|131|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
5353|132|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
5353|133|P|blood sugar level, such as dizziness and sweating, are not||
5353|134|P|affected by this drug.||
5353|135|P|   If you have diabetes, this product may make it harder to||
5353|136|P|control your blood sugar levels. Check your blood sugar levels||
5353|137|P|regularly as directed by your doctor. Tell your doctor right away||
5353|138|P|if you have symptoms of high blood sugar such as increased||
5353|139|P|thirst/urination. Your doctor may need to adjust your diabetes||
5353|140|P|medication, exercise program, or diet.||
5353|141|P|   Children may be at greater risk for low blood sugar||
5353|142|P|(hypoglycemia) while using this drug, especially if they are||
5353|143|P|vomiting or not eating regularly. To help prevent low blood||
5353|144|P|sugar, make sure children eat regularly. If your child cannot eat||
5353|145|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
5353|146|P|as sweating, shaking), tell the doctor right away.||
5353|147|P|   Tell your doctor if you are pregnant or plan to become||
5353|148|P|pregnant. You should not become pregnant while using atenolol.||
5353|149|P|Atenolol may harm an unborn baby. If you become pregnant, talk to||
5353|150|P|your doctor right away about the risks and benefits of this||
5353|151|P|medication.||
5353|152|P|   This medication passes into breast milk and may have||
5353|153|P|undesirable effects on a nursing infant. Consult your doctor||
5353|154|P|before breastfeeding.||
5353|155|B|||
5353|156|I|DRUG INTERACTIONS:  See also How To Use section.||
5353|157|I|   Drug interactions may change how your medications work or||
5353|158|I|increase your risk for serious side effects. This document does||
5353|159|I|not contain all possible drug interactions. Keep a list of all||
5353|160|I|the products you use (including prescription/nonprescription||
5353|161|I|drugs and herbal products) and share it with your doctor and||
5353|162|I|pharmacist. Do not start, stop, or change the dosage of any||
5353|163|I|medicines without your doctor's approval.||
5353|164|I|   A product that may interact with this drug is: fingolimod.||
5353|165|I|   Some products have ingredients that could raise your heart||
5353|166|I|rate or blood pressure or worsen your heart failure. Tell your||
5353|167|I|pharmacist what products you are using, and ask how to use them||
5353|168|I|safely (especially cough-and-cold products, diet aids, or NSAIDs||
5353|169|I|such as ibuprofen/naproxen).||
5353|170|B|||
5353|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5353|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5353|173|O|poison control center right away. US residents can call||
5353|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5353|175|O|Symptoms of overdose may include: very slow heartbeat, severe||
5353|176|O|dizziness, severe weakness, fainting, trouble breathing.||
5353|177|B|||
5353|178|N|NOTES:  Do not share this medication with others.||
5353|179|N|   Lifestyle changes such as stress reduction programs, exercise||
5353|180|N|and dietary changes may increase the effectiveness of this||
5353|181|N|medicine. Talk to your doctor or pharmacist about lifestyle||
5353|182|N|changes that might benefit you.||
5353|183|N|   Check your blood pressure and pulse (heart rate) regularly||
5353|184|N|while taking this medication. Learn how to monitor your own blood||
5353|185|N|pressure and pulse at home, and share the results with your||
5353|186|N|doctor.||
5353|187|B|||
5353|188|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
5353|189|D|remember. If it is near the time of the next dose, skip the||
5353|190|D|missed dose. Take your next dose at the regular time. Do not||
5353|191|D|double the dose to catch up.||
5353|192|B|||
5353|193|R|STORAGE:  Store at room temperature away from light and moisture.||
5353|194|R|Do not store in the bathroom. Keep all medications away from||
5353|195|R|children and pets.||
5353|196|R|   Do not flush medications down the toilet or pour them into a||
5353|197|R|drain unless instructed to do so. Properly discard this product||
5353|198|R|when it is expired or no longer needed. Consult your pharmacist||
5353|199|R|or local waste disposal company.||
5353|200|B|||
5353|201|M|MEDICAL ALERT:  Your condition can cause complications in a||
5353|202|M|medical emergency. For information about enrolling in MedicAlert,||
5353|203|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
5353|204|B|||
5353|205|A|Information last revised October 2024.||
5353|206|A|Copyright(c) 2025 First Databank, Inc.||
5353|207|B|||
5367|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5367|002|Z|does NOT have all possible information about this product. This||
5367|003|Z|information does not assure that this product is safe, effective,||
5367|004|Z|or appropriate for you. This information is not individual||
5367|005|Z|medical advice and does not substitute for the advice of your||
5367|006|Z|health care professional. Always ask your health care||
5367|007|Z|professional for complete information about this product and your||
5367|008|Z|specific health needs.||
5367|009|B|||
5367|010|T|OXAZEPAM - ORAL||
5367|011|F|(ox-AZ-eh-pam)||
5367|012|B|||
5367|013|C|COMMON BRAND NAME(S): Serax||
5367|014|B|||
5367|015|W|WARNING:  Oxazepam has a risk for abuse and addiction, which can||
5367|016|W|lead to overdose and death. Taking this medication with alcohol||
5367|017|W|or other drugs that can cause drowsiness or breathing problems||
5367|018|W|(especially opioid medications such as codeine, hydrocodone) may||
5367|019|W|cause very serious side effects, including death. To lower your||
5367|020|W|risk, your doctor should have you take the smallest dose of||
5367|021|W|oxazepam that works, and take it for the shortest possible time.||
5367|022|W|Be sure you know how to take oxazepam and what other drugs you||
5367|023|W|should avoid taking with it. See also Drug Interactions section.||
5367|024|W|Get medical help right away if any of these very serious side||
5367|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
5367|026|W|severe drowsiness/dizziness, difficulty waking up.||
5367|027|W|   Suddenly stopping this medication may cause serious (possibly||
5367|028|W|fatal) withdrawal, especially if you have used it for a long time||
5367|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
5367|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
5367|031|W|you have any withdrawal symptoms such as headaches, trouble||
5367|032|W|sleeping, restlessness, hallucinations/confusion, depression,||
5367|033|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
5367|034|W|to months.||
5367|035|B|||
5367|036|U|USES:  Oxazepam is used to treat anxiety and also acute alcohol||
5367|037|U|withdrawal. This medication belongs to a class of drugs called||
5367|038|U|benzodiazepines which act on the brain and nerves (central||
5367|039|U|nervous system) to produce a calming and an anti-seizure effect.||
5367|040|U|It works by enhancing the effects of a certain natural substance||
5367|041|U|in the body (GABA).||
5367|042|U|   This medication may also be used for sleep (insomnia)||
5367|043|B|||
5367|044|H|HOW TO USE:  See also Warning section.||
5367|045|H|   Read the Medication Guide provided by your pharmacist before||
5367|046|H|you start taking oxazepam and each time you get a refill. If you||
5367|047|H|have any questions, ask your doctor or pharmacist.||
5367|048|H|   Take this medication by mouth as directed by your doctor. The||
5367|049|H|dosage is based on your medical condition, age, and response to||
5367|050|H|treatment.||
5367|051|H|   When this medication is used for a long time, it may not work||
5367|052|H|as well. Talk with your doctor if this medication stops working||
5367|053|H|well.||
5367|054|H|   Though it helps many people, this medication may sometimes||
5367|055|H|cause addiction. This risk may be higher if you have a substance||
5367|056|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
5367|057|H|Take this medication exactly as prescribed to lower the risk of||
5367|058|H|addiction. Ask your doctor or pharmacist for more details.||
5367|059|H|   Tell your doctor if your condition lasts or gets worse.||
5367|060|B|||
5367|061|S|SIDE EFFECTS:  See also Warning section.||
5367|062|S|   Drowsiness, dizziness, blurred vision, or headache may occur.||
5367|063|S|If any of these effects last or get worse, tell your doctor or||
5367|064|S|pharmacist promptly.||
5367|065|S|   Remember that this medication has been prescribed because your||
5367|066|S|doctor has judged that the benefit to you is greater than the||
5367|067|S|risk of side effects. Many people using this medication do not||
5367|068|S|have serious side effects.||
5367|069|S|   Tell your doctor right away if you have any serious side||
5367|070|S|effects, including: mental/mood changes, trouble speaking,||
5367|071|S|clumsiness, trouble walking, decreased/increased interest in sex,||
5367|072|S|tremor, trouble urinating, sleep disturbances, fainting, unusual||
5367|073|S|tiredness, signs of liver disease (such as nausea/vomiting that||
5367|074|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
5367|075|S|eyes/skin, dark urine), signs of infection (such as sore throat||
5367|076|S|that doesn't go away, fever, chills).||
5367|077|S|   A very serious allergic reaction to this drug is rare.||
5367|078|S|However, get medical help right away if you notice any symptoms||
5367|079|S|of a serious allergic reaction, including: rash, itching/swelling||
5367|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5367|081|S|breathing.||
5367|082|S|   This is not a complete list of possible side effects. If you||
5367|083|S|notice other effects not listed above, contact your doctor or||
5367|084|S|pharmacist.||
5367|085|S|   In the US -||
5367|086|S|   Call your doctor for medical advice about side effects. You||
5367|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5367|088|S|www.fda.gov/medwatch.||
5367|089|S|   In Canada - Call your doctor for medical advice about side||
5367|090|S|effects. You may report side effects to Health Canada at||
5367|091|S|1-866-234-2345.||
5367|092|B|||
5367|093|P|PRECAUTIONS:  Before taking oxazepam, tell your doctor or||
5367|094|P|pharmacist if you are allergic to it; or to other benzodiazepines||
5367|095|P|(such as diazepam, temazepam); or if you have any other||
5367|096|P|allergies. This product may contain inactive ingredients, which||
5367|097|P|can cause allergic reactions or other problems. Talk to your||
5367|098|P|pharmacist for more details.||
5367|099|P|   Before using this medication, tell your doctor or pharmacist||
5367|100|P|your medical history, especially of: liver disease, kidney||
5367|101|P|disease, lung/breathing problems (such as COPD, sleep apnea),||
5367|102|P|drug or alcohol abuse.||
5367|103|P|   This drug may make you dizzy or drowsy or blur your vision.||
5367|104|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
5367|105|P|drowsy. Do not drive, use machinery, or do anything that needs||
5367|106|P|alertness or clear vision until you can do it safely. Avoid||
5367|107|P|alcoholic beverages. Talk to your doctor if you are using||
5367|108|P|marijuana (cannabis).||
5367|109|P|   Older adults may be more sensitive to the side effects of this||
5367|110|P|drug, especially drowsiness. This side effect can increase the||
5367|111|P|risk of falling.||
5367|112|P|   Tell your doctor if you are pregnant or plan to become||
5367|113|P|pregnant. You should not become pregnant while using oxazepam.||
5367|114|P|Oxazepam may harm an unborn baby. Newborn babies of mothers who||
5367|115|P|use this medication late in pregnancy may have symptoms such as||
5367|116|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
5367|117|P|feeding. If you become pregnant, talk to your doctor right away||
5367|118|P|about the risks and benefits of this medication.||
5367|119|P|   This drug passes into breast milk and may have undesirable||
5367|120|P|effects on a nursing infant. Consult your doctor before||
5367|121|P|breastfeeding.||
5367|122|B|||
5367|123|I|DRUG INTERACTIONS:  See also Warning section.||
5367|124|I|   Drug interactions may change how your medications work or||
5367|125|I|increase your risk for serious side effects. This document does||
5367|126|I|not contain all possible drug interactions. Keep a list of all||
5367|127|I|the products you use (including prescription/nonprescription||
5367|128|I|drugs and herbal products) and share it with your doctor and||
5367|129|I|pharmacist. Do not start, stop, or change the dosage of any||
5367|130|I|medicines without your doctor's approval.||
5367|131|I|   Some products that may interact with this drug are: clozapine,||
5367|132|I|digoxin, kava, orlistat, sodium oxybate.||
5367|133|I|   The risk of serious side effects (such as slow/shallow||
5367|134|I|breathing, severe drowsiness/dizziness) may be increased if this||
5367|135|I|medication is taken with other products that may also cause||
5367|136|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
5367|137|I|if you are taking other products such as opioid pain or cough||
5367|138|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
5367|139|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
5367|140|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
5367|141|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
5367|142|I|diphenhydramine).||
5367|143|I|   Check the labels on all your medicines (such as allergy or||
5367|144|I|cough-and-cold products) because they may contain ingredients||
5367|145|I|that cause drowsiness. Ask your pharmacist about using those||
5367|146|I|products safely.||
5367|147|I|   Smoking can decrease the effectiveness of this drug (through||
5367|148|I|liver enzyme induction). Tell your doctor if you smoke or if you||
5367|149|I|have recently stopped smoking because your dose may need to be||
5367|150|I|adjusted.||
5367|151|B|||
5367|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5367|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5367|154|O|poison control center right away. US residents can call||
5367|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5367|156|O|Symptoms of overdose may include: severe drowsiness,||
5367|157|O|slowed/reduced reflexes, slowed breathing, fainting, loss of||
5367|158|O|consciousness.||
5367|159|B|||
5367|160|N|NOTES:  Do not share this medication with others. Sharing it is||
5367|161|N|against the law.||
5367|162|N|   If this drug is used for an extended period of time, lab||
5367|163|N|and/or medical tests (such as liver function, complete blood||
5367|164|N|count) may be done while you are taking this medication. Keep all||
5367|165|N|medical and lab appointments. Consult your doctor for more||
5367|166|N|details.||
5367|167|B|||
5367|168|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5367|169|D|If it is near the time of the next dose, skip the missed dose.||
5367|170|D|Use your next dose at the regular time. Do not double the dose to||
5367|171|D|catch up.||
5367|172|B|||
5367|173|R|STORAGE:  Store at room temperature away from light and moisture.||
5367|174|R|Do not store in the bathroom. Keep all medications away from||
5367|175|R|children and pets.||
5367|176|R|   Do not flush medications down the toilet or pour them into a||
5367|177|R|drain unless instructed to do so. Properly discard this product||
5367|178|R|when it is expired or no longer needed. Consult your pharmacist||
5367|179|R|or local waste disposal company.||
5367|180|B|||
5367|181|A|Information last revised May 2025.||
5367|182|A|Copyright(c) 2025 First Databank, Inc.||
5367|183|B|||
5372|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
5372|002|Z|does NOT have all possible information about this product. This||
5372|003|Z|information does not assure that this product is safe, effective,||
5372|004|Z|or appropriate for you. This information is not individual||
5372|005|Z|medical advice and does not substitute for the advice of your||
5372|006|Z|health care professional. Always ask your health care||
5372|007|Z|professional for complete information about this product and your||
5372|008|Z|specific health needs.||
5372|009|B|||
5372|010|T|IRBESARTAN/HYDROCHLOROTHIAZIDE - ORAL||
5372|011|F|(ir-be-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)||
5372|012|B|||
5372|013|C|COMMON BRAND NAME(S): Avalide||
5372|014|B|||
5372|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
5372|016|W|unborn baby if used during pregnancy. It is important to prevent||
5372|017|W|pregnancy while taking this medication. Consult your doctor for||
5372|018|W|more details and to discuss the use of reliable forms of birth||
5372|019|W|control while taking this medication. If you are planning||
5372|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
5372|021|W|your doctor right away.||
5372|022|B|||
5372|023|U|USES:  This drug is used to treat high blood pressure||
5372|024|U|(hypertension). Lowering high blood pressure helps prevent||
5372|025|U|strokes, heart attacks, and kidney problems. This product||
5372|026|U|contains two medications: irbesartan and hydrochlorothiazide.||
5372|027|U|Irbesartan is an angiotensin receptor blocker (ARB) and works by||
5372|028|U|relaxing blood vessels so that blood can flow more easily.||
5372|029|U|Hydrochlorothiazide is a "water pill" (diuretic) that causes you||
5372|030|U|to make more urine, which helps your body get rid of extra salt||
5372|031|U|and water.||
5372|032|B|||
5372|033|V|OTHER USES:  This section contains uses of this drug that are not||
5372|034|V|listed in the approved professional labeling for the drug but||
5372|035|V|that may be prescribed by your health care professional. Use this||
5372|036|V|drug for a condition that is listed in this section only if it||
5372|037|V|has been so prescribed by your health care professional.||
5372|038|V|   This drug may also be used for heart failure.||
5372|039|B|||
5372|040|H|HOW TO USE:  Take this medication by mouth as directed by your||
5372|041|H|doctor, usually once daily with or without food. If this||
5372|042|H|medication causes you to urinate more often, it is best to take||
5372|043|H|it at least 4 hours before your bedtime to prevent having to get||
5372|044|H|up to urinate.||
5372|045|H|   If you also take certain drugs to lower your cholesterol (bile||
5372|046|H|acid-binding resins such as cholestyramine or colestipol), take||
5372|047|H|irbesartan/hydrochlorothiazide at least 4 hours before or at||
5372|048|H|least 4 to 6 hours after these medications.||
5372|049|H|   The dosage is based on your medical condition and response to||
5372|050|H|treatment.||
5372|051|H|   Use this medication regularly to get the most benefit from it.||
5372|052|H|To help you remember, take it at the same time each day. Keep||
5372|053|H|taking this medication even if you feel well. Most people with||
5372|054|H|high blood pressure do not feel sick.||
5372|055|H|   Tell your doctor if your condition does not get better or if||
5372|056|H|it gets worse (your blood pressure readings remain high or||
5372|057|H|increase).||
5372|058|B|||
5372|059|S|SIDE EFFECTS:  Dizziness, lightheadedness, or upset stomach may||
5372|060|S|occur as your body adjusts to the medication. If any of these||
5372|061|S|effects last or get worse, tell your doctor or pharmacist||
5372|062|S|promptly.||
5372|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
5372|064|S|slowly when rising from a sitting or lying position.||
5372|065|S|   Remember that this medication has been prescribed because your||
5372|066|S|doctor has judged that the benefit to you is greater than the||
5372|067|S|risk of side effects. Many people using this medication do not||
5372|068|S|have serious side effects.||
5372|069|S|   This product may cause dehydration and electrolyte imbalance.||
5372|070|S|Tell your doctor right away if you have any symptoms of||
5372|071|S|dehydration or electrolyte imbalance, including unusual dry||
5372|072|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
5372|073|S|heartbeat, or confusion.||
5372|074|S|   Tell your doctor right away if you have any serious side||
5372|075|S|effects, including: fainting, decrease in vision, eye pain, signs||
5372|076|S|of kidney problems (such as change in the amount of urine).||
5372|077|S|   A very serious allergic reaction to this drug is rare.||
5372|078|S|However, get medical help right away if you notice any symptoms||
5372|079|S|of a serious allergic reaction, including: rash, itching/swelling||
5372|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
5372|081|S|breathing.||
5372|082|S|   This is not a complete list of possible side effects. If you||
5372|083|S|notice other effects not listed above, contact your doctor or||
5372|084|S|pharmacist.||
5372|085|S|   In the US -||
5372|086|S|   Call your doctor for medical advice about side effects. You||
5372|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
5372|088|S|www.fda.gov/medwatch.||
5372|089|S|   In Canada - Call your doctor for medical advice about side||
5372|090|S|effects. You may report side effects to Health Canada at||
5372|091|S|1-866-234-2345.||
5372|092|B|||
5372|093|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
5372|094|P|pharmacist if you are allergic to irbesartan or||
5372|095|P|hydrochlorothiazide; or if you have any other allergies. This||
5372|096|P|product may contain inactive ingredients, which can cause||
5372|097|P|allergic reactions or other problems. Talk to your pharmacist for||
5372|098|P|more details.||
5372|099|P|   Before using this medication, tell your doctor or pharmacist||
5372|100|P|your medical history, especially of: gout, kidney disease, liver||
5372|101|P|disease, lupus, dehydration, high level of potassium in the||
5372|102|P|blood, skin cancer.||
5372|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
5372|104|P|can make you more dizzy. Do not drive, use machinery, or do||
5372|105|P|anything that needs alertness until you can do it safely. Limit||
5372|106|P|alcoholic beverages. Talk to your doctor if you are using||
5372|107|P|marijuana (cannabis).||
5372|108|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
5372|109|P|and cause you to feel lightheaded. Tell your doctor if you have||
5372|110|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
5372|111|P|of fluids unless your doctor tells you not to.||
5372|112|P|   If you have diabetes, this product may affect your blood||
5372|113|P|sugar. Check your blood sugar regularly as directed and share the||
5372|114|P|results with your doctor. Your doctor may need to adjust your||
5372|115|P|diabetes medication, exercise program, or diet.||
5372|116|P|   This medication may make you more sensitive to the sun. It may||
5372|117|P|also increase your risk for skin cancer, especially if you take||
5372|118|P|it for a long time. Limit your time in the sun. Avoid tanning||
5372|119|P|booths and sunlamps. Use sunscreen and wear protective clothing||
5372|120|P|when outdoors. Tell your doctor right away if you get sunburned,||
5372|121|P|have skin blisters/redness, or notice new or changed moles/skin||
5372|122|P|lesions.||
5372|123|P|   This product may affect your potassium levels. Before using||
5372|124|P|potassium supplements or salt substitutes that contain potassium,||
5372|125|P|consult your doctor or pharmacist.||
5372|126|P|   Before having surgery, tell your doctor or dentist about all||
5372|127|P|the products you use (including prescription drugs,||
5372|128|P|nonprescription drugs, and herbal products).||
5372|129|P|   Older adults may be more sensitive to the side effects of this||
5372|130|P|drug, especially dizziness and change in the amount of urine||
5372|131|P|(kidney problems).||
5372|132|P|   Tell your doctor if you are pregnant or plan to become||
5372|133|P|pregnant. You should not become pregnant while using||
5372|134|P|irbesartan/hydrochlorothiazide. This medication may harm an||
5372|135|P|unborn baby. If you become pregnant, talk to your doctor right||
5372|136|P|away about the risks and benefits of this medication. (See also||
5372|137|P|Warning section.)||
5372|138|P|   It is unknown if irbesartan passes into breast milk.||
5372|139|P|Hydrochlorothiazide passes into breast milk, but is unlikely to||
5372|140|P|harm a nursing infant. Consult your doctor before breastfeeding.||
5372|141|B|||
5372|142|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
5372|143|I|   Drug interactions may change how your medications work or||
5372|144|I|increase your risk for serious side effects. This document does||
5372|145|I|not contain all possible drug interactions. Keep a list of all||
5372|146|I|the products you use (including prescription/nonprescription||
5372|147|I|drugs and herbal products) and share it with your doctor and||
5372|148|I|pharmacist. Do not start, stop, or change the dosage of any||
5372|149|I|medicines without your doctor's approval.||
5372|150|I|   Some products that may interact with this drug include:||
5372|151|I|aliskiren, dofetilide, lithium, drugs that may increase the level||
5372|152|I|of potassium in the blood (such as sparsentan, ACE inhibitors||
5372|153|I|including benazepril/lisinopril, birth control pills containing||
5372|154|I|drospirenone).||
5372|155|I|   Some products have ingredients that could raise your blood||
5372|156|I|pressure or worsen your heart failure. Tell your pharmacist what||
5372|157|I|products you are using, and ask how to use them safely||
5372|158|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
5372|159|I|ibuprofen/naproxen).||
5372|160|I|   This medication may interfere with certain lab tests (such as||
5372|161|I|parathyroid function), possibly causing false test results. Make||
5372|162|I|sure lab personnel and all your doctors know you use this drug.||
5372|163|B|||
5372|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
5372|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
5372|166|O|poison control center right away. US residents can call||
5372|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
5372|168|O|Symptoms of overdose may include: severe dizziness, fainting.||
5372|169|B|||
5372|170|N|NOTES:  Do not share this medication with others.||
5372|171|N|   Lifestyle changes such as stress reduction programs, exercise,||
5372|172|N|and dietary changes may increase the effectiveness of this||
5372|173|N|medicine. Talk to your doctor or pharmacist about lifestyle||
5372|174|N|changes that might benefit you.||
5372|175|N|   Lab and/or medical tests (such as kidney function, potassium||
5372|176|N|levels, skin exams, cholesterol levels) should be done while you||
5372|177|N|are taking this medication. Keep all medical and lab||
5372|178|N|appointments. Consult your doctor for more details.||
5372|179|N|   Check your blood pressure regularly while taking this||
5372|180|N|medication. Learn how to monitor your own blood pressure, and||
5372|181|N|share the results with your doctor.||
5372|182|B|||
5372|183|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
5372|184|D|If it is near the time of the next dose, skip the missed dose.||
5372|185|D|Use your next dose at the regular time. Do not double the dose to||
5372|186|D|catch up.||
5372|187|B|||
5372|188|R|STORAGE:  Store at room temperature away from light and moisture.||
5372|189|R|Do not store in the bathroom. Keep all medications away from||
5372|190|R|children and pets.||
5372|191|R|   Do not flush medications down the toilet or pour them into a||
5372|192|R|drain unless instructed to do so. Properly discard this product||
5372|193|R|when it is expired or no longer needed. Consult your pharmacist||
5372|194|R|or local waste disposal company.||
5372|195|B|||
5372|196|A|Information last revised March 2025.||
5372|197|A|Copyright(c) 2025 First Databank, Inc.||
5372|198|B|||
6004|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6004|002|Z|does NOT have all possible information about this product. This||
6004|003|Z|information does not assure that this product is safe, effective,||
6004|004|Z|or appropriate for you. This information is not individual||
6004|005|Z|medical advice and does not substitute for the advice of your||
6004|006|Z|health care professional. Always ask your health care||
6004|007|Z|professional for complete information about this product and your||
6004|008|Z|specific health needs.||
6004|009|B|||
6004|010|T|SCOPOLAMINE - TRANSDERMAL||
6004|011|F|(skoe-POL-a-meen)||
6004|012|B|||
6004|013|C|COMMON BRAND NAME(S): Transderm-Scop||
6004|014|B|||
6004|015|U|USES:  This skin patch is used to prevent nausea and vomiting||
6004|016|U|caused by motion sickness or recovery from anesthesia and||
6004|017|U|surgery. This medication works by correcting the imbalance of||
6004|018|U|natural substances (acetylcholine and norepinephrine) that can||
6004|019|U|occur in motion sickness. It also blocks certain signals to the||
6004|020|U|brain that can cause nausea and vomiting.||
6004|021|B|||
6004|022|H|HOW TO USE:  Read the Patient Information Leaflet and||
6004|023|H|Instructions for Use if available from your pharmacist before you||
6004|024|H|start using scopolamine and each time you get a refill. If you||
6004|025|H|have any questions, ask your doctor or pharmacist.||
6004|026|H|   Peel off the clear backing from the patch and apply the patch||
6004|027|H|firmly to a clean, dry, hairless area of the skin behind the ear.||
6004|028|H|The patch will slowly release the medication into your body over||
6004|029|H|3 days. Do not use the patch if it is broken, cut, or damaged.||
6004|030|H|After applying the patch, do not touch or apply pressure to the||
6004|031|H|patch, since doing so may cause the medication to leak out.||
6004|032|H|   If you are using the patch to prevent nausea and vomiting from||
6004|033|H|motion sickness, apply the patch as directed by your doctor,||
6004|034|H|usually at least 4 hours before the activity that causes motion||
6004|035|H|sickness. Replace the patch every 3 days until it is no longer||
6004|036|H|needed.||
6004|037|H|   If you are using the patch to prevent nausea and vomiting||
6004|038|H|after surgery, apply the patch as directed by your doctor,||
6004|039|H|usually the evening before surgery. If the surgery is for a||
6004|040|H|cesarean section, then the patch is usually applied 1 hour before||
6004|041|H|the procedure to reduce the baby's exposure to the drug. Remove||
6004|042|H|and throw away the patch as directed by your doctor, usually 24||
6004|043|H|hours after surgery.||
6004|044|H|   If the patch comes off or needs to be replaced, throw away the||
6004|045|H|old patch and place a new one behind the other ear, on a clean,||
6004|046|H|dry, hairless area. Use only one patch at a time. When throwing||
6004|047|H|away the old patch, fold it in half with the sticky side together||
6004|048|H|and throw away in the trash away from children and pets.||
6004|049|H|   This medication can cause temporary blurred vision and widened||
6004|050|H|pupils if it comes in contact with the eyes. After handling the||
6004|051|H|patch, always wash your hands thoroughly with soap and water.||
6004|052|H|Also wash the area behind the ear where the patch was removed.||
6004|053|H|   After stopping this medication, you may experience dizziness,||
6004|054|H|loss of balance, nausea/vomiting, headache, muscle weakness, or||
6004|055|H|slow heartbeat. If these effects occur, they usually appear 24||
6004|056|H|hours or more after you stop this medication. This is a result of||
6004|057|H|your body adjusting to being off the medication. Report any such||
6004|058|H|reactions to your doctor right away.||
6004|059|H|   Tell your doctor if your condition lasts or gets worse.||
6004|060|B|||
6004|061|S|SIDE EFFECTS:  Blurred vision and widened pupils may occur as||
6004|062|S|your body adjusts to the medication. Dry mouth, drowsiness,||
6004|063|S|dizziness, decreased sweating, constipation, and mild||
6004|064|S|itching/redness on application site may also occur. If any of||
6004|065|S|these effects last or get worse, tell your doctor or pharmacist||
6004|066|S|promptly.||
6004|067|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
6004|068|S|chips, chew (sugarless) gum, drink water, or use a saliva||
6004|069|S|substitute.||
6004|070|S|   Remember that this medication has been prescribed because your||
6004|071|S|doctor has judged that the benefit to you is greater than the||
6004|072|S|risk of side effects. Many people using this medication do not||
6004|073|S|have serious side effects.||
6004|074|S|   Remove the patch and tell your doctor right away if you have||
6004|075|S|any serious side effects, including: mental/mood changes (such as||
6004|076|S|confusion, agitation), difficulty urinating, fast/irregular||
6004|077|S|heartbeat.||
6004|078|S|   Remove the patch and get medical help right away if you have||
6004|079|S|any very serious side effects, including: eye||
6004|080|S|pain/swelling/redness, vision changes (such as seeing rainbows||
6004|081|S|around lights at night), seizures.||
6004|082|S|   A very serious allergic reaction to this drug is rare.||
6004|083|S|However, get medical help right away if you notice any symptoms||
6004|084|S|of a serious allergic reaction, including: rash, itching/swelling||
6004|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6004|086|S|breathing.||
6004|087|S|   This is not a complete list of possible side effects. If you||
6004|088|S|notice other effects not listed above, contact your doctor or||
6004|089|S|pharmacist.||
6004|090|S|   In the US -||
6004|091|S|   Call your doctor for medical advice about side effects. You||
6004|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6004|093|S|www.fda.gov/medwatch.||
6004|094|S|   In Canada - Call your doctor for medical advice about side||
6004|095|S|effects. You may report side effects to Health Canada at||
6004|096|S|1-866-234-2345.||
6004|097|B|||
6004|098|P|PRECAUTIONS:  Before using scopolamine, tell your doctor or||
6004|099|P|pharmacist if you are allergic to it; or to other belladonna||
6004|100|P|alkaloids (such as atropine); or if you have any other allergies.||
6004|101|P|This product may contain inactive ingredients, which can cause||
6004|102|P|allergic reactions or other problems. Talk to your pharmacist for||
6004|103|P|more details.||
6004|104|P|   Before using this medication, tell your doctor or pharmacist||
6004|105|P|your medical history, especially of: breathing problems (such as||
6004|106|P|asthma, emphysema), personal or family history of glaucoma||
6004|107|P|(angle-closure type), heart disease, high blood pressure,||
6004|108|P|seizures, stomach/intestine/esophagus problems (such as ulcers,||
6004|109|P|blockage, GERD), overactive thyroid (hyperthyroidism), difficulty||
6004|110|P|urinating (for example, due to enlarged prostate), mental/mood||
6004|111|P|disorders (such as psychosis, anxiety), kidney disease, liver||
6004|112|P|disease, myasthenia gravis, uncontrolled pain.||
6004|113|P|   This drug may make you dizzy or drowsy or blur your vision.||
6004|114|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
6004|115|P|drowsy. Do not drive, use machinery, participate in underwater||
6004|116|P|activities, or do anything that needs alertness or clear vision||
6004|117|P|until you can do it safely. Avoid alcoholic beverages. Talk to||
6004|118|P|your doctor if you are using marijuana (cannabis).||
6004|119|P|   Before having surgery, tell your doctor or dentist about all||
6004|120|P|the products you use (including prescription drugs,||
6004|121|P|nonprescription drugs, and herbal products).||
6004|122|P|   If you are going to have an MRI test, tell testing personnel||
6004|123|P|that you are using this patch. Some patches may contain metals||
6004|124|P|that can cause serious burns during an MRI. Ask your doctor||
6004|125|P|whether you will need to remove your patch before the test and||
6004|126|P|apply a new patch afterward, and how to do so properly.||
6004|127|P|   This medication may make you sweat less, making you more||
6004|128|P|likely to get heat stroke. Avoid doing things that may cause you||
6004|129|P|to overheat, such as hard work or exercise in hot weather, or||
6004|130|P|using hot tubs. When the weather is hot, drink a lot of fluids||
6004|131|P|and dress lightly. If you overheat, remove the patch and quickly||
6004|132|P|look for a place to cool down and rest. Get medical help right||
6004|133|P|away if you have a fever that does not go away, mental/mood||
6004|134|P|changes, headache, or dizziness.||
6004|135|P|   Older adults may be more sensitive to the side effects of this||
6004|136|P|drug, especially dizziness, drowsiness, heat strokes, and||
6004|137|P|mental/mood changes (such as confusion).||
6004|138|P|   Children may be more sensitive to the side effects of this||
6004|139|P|drug, especially dizziness, drowsiness, heat strokes, and||
6004|140|P|mental/mood changes (such as confusion).||
6004|141|P|   During pregnancy, this medication should be used only when||
6004|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
6004|143|P|   This medication passes into breast milk. Consult your doctor||
6004|144|P|before breastfeeding.||
6004|145|B|||
6004|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6004|147|I|medications work or increase your risk for serious side effects.||
6004|148|I|This document does not contain all possible drug interactions.||
6004|149|I|Keep a list of all the products you use (including||
6004|150|I|prescription/nonprescription drugs and herbal products) and share||
6004|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
6004|152|I|the dosage of any medicines without your doctor's approval.||
6004|153|I|   Some products that may interact with this drug include:||
6004|154|I|potassium tablets/capsules, pramlintide.||
6004|155|I|   Tell your doctor or pharmacist if you are taking other||
6004|156|I|products that cause drowsiness including alcohol, marijuana||
6004|157|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
6004|158|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
6004|159|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
6004|160|I|codeine).||
6004|161|I|   Check the labels on all your medicines (such as allergy or||
6004|162|I|cough-and-cold products) because they may contain ingredients||
6004|163|I|that cause drowsiness. Ask your pharmacist about using those||
6004|164|I|products safely.||
6004|165|I|   This medication may interfere with certain lab tests (such as||
6004|166|I|gastric secretion test), possibly causing false test results.||
6004|167|I|Make sure lab personnel and all your doctors know you use this||
6004|168|I|drug.||
6004|169|B|||
6004|170|O|OVERDOSE:  This medication patch may be harmful if chewed or||
6004|171|O|swallowed. If someone has overdosed, remove the patch if||
6004|172|O|possible. For serious symptoms such as passing out or trouble||
6004|173|O|breathing, call 911. Otherwise, call a poison control center||
6004|174|O|right away. US residents can call 1-800-222-1222. Canada||
6004|175|O|residents can call 1-844-764-7669. Symptoms of overdose may||
6004|176|O|include: severe drowsiness, mental/mood changes (confusion,||
6004|177|O|hallucinations), fast/irregular heartbeat, seizures, hot/dry||
6004|178|O|skin.||
6004|179|B|||
6004|180|N|NOTES:  Do not share this medication with others.||
6004|181|B|||
6004|182|D|MISSED DOSE:  If you forget to replace a patch at the scheduled||
6004|183|D|time, replace it as soon as you remember. Do not use more than||
6004|184|D|one patch at a time.||
6004|185|B|||
6004|186|R|STORAGE:  Store upright at room temperature. Keep all medications||
6004|187|R|away from children and pets.||
6004|188|R|   Do not flush medications down the toilet or pour them into a||
6004|189|R|drain unless instructed to do so. Properly discard this product||
6004|190|R|when it is expired or no longer needed. Consult your pharmacist||
6004|191|R|or local waste disposal company.||
6004|192|B|||
6004|193|A|Information last revised June 2025.||
6004|194|A|Copyright(c) 2025 First Databank, Inc.||
6004|195|B|||
6006|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6006|002|Z|does NOT have all possible information about this product. This||
6006|003|Z|information does not assure that this product is safe, effective,||
6006|004|Z|or appropriate for you. This information is not individual||
6006|005|Z|medical advice and does not substitute for the advice of your||
6006|006|Z|health care professional. Always ask your health care||
6006|007|Z|professional for complete information about this product and your||
6006|008|Z|specific health needs.||
6006|009|B|||
6006|010|T|CLONAZEPAM - ORAL||
6006|011|F|(klo-NAY-zeh-pam)||
6006|012|B|||
6006|013|C|COMMON BRAND NAME(S): Klonopin||
6006|014|B|||
6006|015|W|WARNING:  Clonazepam has a risk for abuse and addiction, which||
6006|016|W|can lead to overdose and death. Taking this medication with||
6006|017|W|alcohol or other drugs that can cause drowsiness or breathing||
6006|018|W|problems (especially opioid medications such as codeine,||
6006|019|W|hydrocodone) may cause very serious side effects, including||
6006|020|W|death. To lower your risk, your doctor should have you take the||
6006|021|W|smallest dose of clonazepam that works, and take it for the||
6006|022|W|shortest possible time. Be sure you know how to take clonazepam||
6006|023|W|and what other drugs you should avoid taking with it. See also||
6006|024|W|Drug Interactions section. Get medical help right away if any of||
6006|025|W|these very serious side effects occur: slow/shallow breathing,||
6006|026|W|unusual lightheadedness, severe drowsiness/dizziness, difficulty||
6006|027|W|waking up.||
6006|028|W|   Suddenly stopping this medication may cause serious (possibly||
6006|029|W|fatal) withdrawal, especially if you have used it for a long time||
6006|030|W|or in high doses. To prevent withdrawal, your doctor may lower||
6006|031|W|your dose slowly. Tell your doctor or pharmacist right away if||
6006|032|W|you have any withdrawal symptoms such as headaches, trouble||
6006|033|W|sleeping, restlessness, hallucinations/confusion, depression,||
6006|034|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
6006|035|W|to months.||
6006|036|B|||
6006|037|U|USES:  Clonazepam is used to prevent and control seizures. This||
6006|038|U|medication is known as an anticonvulsant or antiepileptic drug.||
6006|039|U|It is also used to treat panic attacks. Clonazepam works by||
6006|040|U|calming your brain and nerves. It belongs to a class of drugs||
6006|041|U|called benzodiazepines.||
6006|042|B|||
6006|043|V|OTHER USES:  This section contains uses of this drug that are not||
6006|044|V|listed in the approved professional labeling for the drug but||
6006|045|V|that may be prescribed by your health care professional. Use this||
6006|046|V|drug for a condition that is listed in this section only if it||
6006|047|V|has been so prescribed by your health care professional.||
6006|048|V|   This drug may also be used for anxiety disorders or movement||
6006|049|V|disorders (such as tremors, akathisia).||
6006|050|B|||
6006|051|H|HOW TO USE:  See also Warning section.||
6006|052|H|   Read the Medication Guide provided by your pharmacist before||
6006|053|H|you start taking clonazepam and each time you get a refill. If||
6006|054|H|you have any questions, ask your doctor or pharmacist.||
6006|055|H|   Take this medication by mouth as directed by your doctor,||
6006|056|H|usually 2 or 3 times daily. Swallow this medication whole with||
6006|057|H|water.||
6006|058|H|   The dosage is based on your medical condition, age, and||
6006|059|H|response to treatment. Children's dosage is also based on weight.||
6006|060|H|Older adults usually start with a lower dose to decrease the risk||
6006|061|H|of side effects. Do not increase your dose, take it more often,||
6006|062|H|or take it for a longer time than directed.||
6006|063|H|   Take this medication regularly to get the most benefit from||
6006|064|H|it. To help you remember, take it at the same times each day.||
6006|065|H|   Do not stop taking this medication without consulting your||
6006|066|H|doctor. Some conditions may become worse when this drug is||
6006|067|H|suddenly stopped. Your dose may need to be gradually decreased.||
6006|068|H|   When this medication is used for a long time, it may not work||
6006|069|H|as well. Talk with your doctor if this medication stops working||
6006|070|H|well.||
6006|071|H|   Though it helps many people, this medication may sometimes||
6006|072|H|cause addiction. This risk may be higher if you have a substance||
6006|073|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
6006|074|H|Take this medication exactly as prescribed to lower the risk of||
6006|075|H|addiction. Ask your doctor or pharmacist for more details.||
6006|076|H|   If you have several different types of seizure disorders, you||
6006|077|H|may experience a worsening of seizures when you first start using||
6006|078|H|clonazepam. Consult your doctor right away if this happens. Your||
6006|079|H|doctor may need to add or adjust the dose of your other||
6006|080|H|medications to control the seizures.||
6006|081|H|   Tell your doctor if your condition lasts or gets worse.||
6006|082|B|||
6006|083|S|SIDE EFFECTS:  See also Warning section.||
6006|084|S|   Drowsiness, dizziness, tiredness, loss of coordination, or||
6006|085|S|increased saliva production may occur. If any of these effects||
6006|086|S|last or get worse, tell your doctor or pharmacist promptly.||
6006|087|S|   Remember that this medication has been prescribed because your||
6006|088|S|doctor has judged that the benefit to you is greater than the||
6006|089|S|risk of side effects. Many people using this medication do not||
6006|090|S|have serious side effects.||
6006|091|S|   A small number of people who take anticonvulsants for any||
6006|092|S|condition (such as seizures, bipolar disorder, pain) may||
6006|093|S|experience depression, suicidal thoughts/attempts, or other||
6006|094|S|mental/mood problems. Tell your doctor right away if you or your||
6006|095|S|family/caregiver notice any unusual/sudden changes in your mood,||
6006|096|S|thoughts, or behavior, including: confusion, memory problems,||
6006|097|S|signs of depression, suicidal thoughts/attempts, thoughts about||
6006|098|S|harming yourself.||
6006|099|S|   A very serious allergic reaction to this drug is rare.||
6006|100|S|However, get medical help right away if you notice any symptoms||
6006|101|S|of a serious allergic reaction, including: rash, itching/swelling||
6006|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6006|103|S|breathing.||
6006|104|S|   This is not a complete list of possible side effects. If you||
6006|105|S|notice other effects not listed above, contact your doctor or||
6006|106|S|pharmacist.||
6006|107|S|   In the US -||
6006|108|S|   Call your doctor for medical advice about side effects. You||
6006|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6006|110|S|www.fda.gov/medwatch.||
6006|111|S|   In Canada - Call your doctor for medical advice about side||
6006|112|S|effects. You may report side effects to Health Canada at||
6006|113|S|1-866-234-2345.||
6006|114|B|||
6006|115|P|PRECAUTIONS:  Before taking clonazepam, tell your doctor or||
6006|116|P|pharmacist if you are allergic to it; or to other benzodiazepines||
6006|117|P|(such as diazepam, lorazepam); or if you have any other||
6006|118|P|allergies. This product may contain inactive ingredients, which||
6006|119|P|can cause allergic reactions or other problems. Talk to your||
6006|120|P|pharmacist for more details.||
6006|121|P|   Before using this medication, tell your doctor or pharmacist||
6006|122|P|your medical history, especially of: a certain type of eye||
6006|123|P|problem (narrow angle glaucoma), a certain blood disorder||
6006|124|P|(porphyria), liver disease, kidney disease, lung/breathing||
6006|125|P|problems, mental/mood problems (such as depression, thoughts of||
6006|126|P|suicide), personal or family history of a substance use disorder||
6006|127|P|(such as overuse of or addiction to drugs/alcohol).||
6006|128|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6006|129|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6006|130|P|machinery, or do anything that needs alertness until you can do||
6006|131|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6006|132|P|are using marijuana (cannabis).||
6006|133|P|   Before having surgery, tell your doctor or dentist about all||
6006|134|P|the products you use (including prescription drugs,||
6006|135|P|nonprescription drugs, and herbal products).||
6006|136|P|   For children, the long-term effects on physical and||
6006|137|P|mental/behavioral development are uncertain and may not be seen||
6006|138|P|until after many years. Discuss the risks and benefits of||
6006|139|P|treatment with clonazepam with your doctor.||
6006|140|P|   Older adults may be more sensitive to the effects of this||
6006|141|P|drug, especially drowsiness and confusion. These side effects can||
6006|142|P|increase the risk of falling.||
6006|143|P|   During pregnancy, this medication should be used only when||
6006|144|P|clearly needed. It may harm an unborn baby. Newborn babies of||
6006|145|P|mothers who use this medication late in pregnancy may have||
6006|146|P|symptoms such as slow/shallow breathing, nonstop crying, shaking,||
6006|147|P|or trouble feeding. However, since untreated seizures are a||
6006|148|P|serious condition that can harm both a pregnant woman and her||
6006|149|P|unborn baby, do not stop taking this medication unless directed||
6006|150|P|by your doctor. If you are planning pregnancy, become pregnant,||
6006|151|P|or think you may be pregnant, talk to your doctor right away||
6006|152|P|about the risks and benefits of this medication.||
6006|153|P|   This drug passes into breast milk and may have undesirable||
6006|154|P|effects on a nursing infant. Consult your doctor before||
6006|155|P|breastfeeding.||
6006|156|B|||
6006|157|I|DRUG INTERACTIONS:  See also Warning section.||
6006|158|I|   Drug interactions may change how your medications work or||
6006|159|I|increase your risk for serious side effects. This document does||
6006|160|I|not contain all possible drug interactions. Keep a list of all||
6006|161|I|the products you use (including prescription/nonprescription||
6006|162|I|drugs and herbal products) and share it with your doctor and||
6006|163|I|pharmacist. Do not start, stop, or change the dosage of any||
6006|164|I|medicines without your doctor's approval.||
6006|165|I|   Some products that may interact with this drug include:||
6006|166|I|orlistat, sodium oxybate.||
6006|167|I|   The risk of serious side effects (such as slow/shallow||
6006|168|I|breathing, severe drowsiness/dizziness) may be increased if this||
6006|169|I|medication is taken with other products that may also cause||
6006|170|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
6006|171|I|if you are taking other products such as opioid pain or cough||
6006|172|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6006|173|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
6006|174|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6006|175|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6006|176|I|diphenhydramine).||
6006|177|I|   Check the labels on all your medicines (such as allergy or||
6006|178|I|cough-and-cold products) because they may contain ingredients||
6006|179|I|that cause drowsiness. Ask your pharmacist about using those||
6006|180|I|products safely.||
6006|181|B|||
6006|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6006|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6006|184|O|poison control center right away. US residents can call||
6006|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6006|186|O|Symptoms of overdose may include: severe drowsiness, confusion,||
6006|187|O|loss of consciousness, slowed/decreased reflexes.||
6006|188|B|||
6006|189|N|NOTES:  Do not share this medication with others. Sharing it is||
6006|190|N|against the law.||
6006|191|N|   Lab and/or medical tests (such as liver function, complete||
6006|192|N|blood count) should be done while you are taking this medication.||
6006|193|N|Keep all medical and lab appointments. Consult your doctor for||
6006|194|N|more details.||
6006|195|B|||
6006|196|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6006|197|D|remember. If it is near the time of the next dose, skip the||
6006|198|D|missed dose. Take your next dose at the regular time. Do not||
6006|199|D|double the dose to catch up.||
6006|200|B|||
6006|201|R|STORAGE:  Store at room temperature away from light and moisture.||
6006|202|R|Do not store in the bathroom. Keep all medications away from||
6006|203|R|children and pets.||
6006|204|R|   Do not flush medications down the toilet or pour them into a||
6006|205|R|drain unless instructed to do so. Properly discard this product||
6006|206|R|when it is expired or no longer needed. Consult your pharmacist||
6006|207|R|or local waste disposal company.||
6006|208|B|||
6006|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
6006|210|M|medical emergency. For information about enrolling in MedicAlert,||
6006|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6006|212|B|||
6006|213|A|Information last revised May 2025.||
6006|214|A|Copyright(c) 2025 First Databank, Inc.||
6006|215|B|||
6010|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6010|002|Z|does NOT have all possible information about this product. This||
6010|003|Z|information does not assure that this product is safe, effective,||
6010|004|Z|or appropriate for you. This information is not individual||
6010|005|Z|medical advice and does not substitute for the advice of your||
6010|006|Z|health care professional. Always ask your health care||
6010|007|Z|professional for complete information about this product and your||
6010|008|Z|specific health needs.||
6010|009|B|||
6010|010|T|ISRADIPINE - ORAL||
6010|011|F|(is-RAD-i-peen)||
6010|012|B|||
6010|013|C|COMMON BRAND NAME(S): Dynacirc||
6010|014|B|||
6010|015|U|USES:  Isradipine is used with or without other medications to||
6010|016|U|treat high blood pressure (hypertension). Lowering high blood||
6010|017|U|pressure helps prevent strokes, heart attacks, and kidney||
6010|018|U|problems. Isradipine is called a calcium channel blocker. It||
6010|019|U|works by relaxing blood vessels so blood can flow more easily.||
6010|020|B|||
6010|021|H|HOW TO USE:  Take this medication by mouth with or without food||
6010|022|H|as directed by your doctor, usually twice daily.||
6010|023|H|   The dosage is based on your medical condition and response to||
6010|024|H|treatment. Your doctor may gradually increase your dose. Follow||
6010|025|H|your doctor's instructions carefully.||
6010|026|H|   Use this medication regularly to get the most benefit from it.||
6010|027|H|To help you remember, take it at the same times each day. Keep||
6010|028|H|taking this medication even if you feel well. Most people with||
6010|029|H|high blood pressure do not feel sick. It may take 2 to 4 weeks||
6010|030|H|before you get the full benefit of this drug.||
6010|031|H|   Tell your doctor if your condition does not get better or if||
6010|032|H|it gets worse (your blood pressure readings remain high or||
6010|033|H|increase).||
6010|034|B|||
6010|035|S|SIDE EFFECTS:  Dizziness, nausea, headache, tiredness, flushing,||
6010|036|S|and swelling of the ankles/feet may occur. If any of these||
6010|037|S|effects last or get worse, tell your doctor or pharmacist||
6010|038|S|promptly.||
6010|039|S|   To reduce the risk of dizziness and lightheadedness, get up||
6010|040|S|slowly when rising from a sitting or lying position.||
6010|041|S|   Remember that this medication has been prescribed because your||
6010|042|S|doctor has judged that the benefit to you is greater than the||
6010|043|S|risk of side effects. Many people using this medication do not||
6010|044|S|have serious side effects.||
6010|045|S|   Tell your doctor right away if you have any serious side||
6010|046|S|effects, including: fainting, fast/irregular/pounding heartbeat,||
6010|047|S|vision changes.||
6010|048|S|   Some people who already have severe heart disease may rarely||
6010|049|S|develop worsening chest pain or a heart attack after starting||
6010|050|S|this medication or increasing the dose. Get medical help right||
6010|051|S|away if you experience: worsening chest pain, symptoms of a heart||
6010|052|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
6010|053|S|unusual sweating).||
6010|054|S|   A very serious allergic reaction to this drug is rare.||
6010|055|S|However, get medical help right away if you notice any symptoms||
6010|056|S|of a serious allergic reaction, including: rash, itching/swelling||
6010|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6010|058|S|breathing.||
6010|059|S|   This is not a complete list of possible side effects. If you||
6010|060|S|notice other effects not listed above, contact your doctor or||
6010|061|S|pharmacist.||
6010|062|S|   In the US -||
6010|063|S|   Call your doctor for medical advice about side effects. You||
6010|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6010|065|S|www.fda.gov/medwatch.||
6010|066|S|   In Canada - Call your doctor for medical advice about side||
6010|067|S|effects. You may report side effects to Health Canada at||
6010|068|S|1-866-234-2345.||
6010|069|B|||
6010|070|P|PRECAUTIONS:  Before taking isradipine, tell your doctor or||
6010|071|P|pharmacist if you are allergic to it; or if you have any other||
6010|072|P|allergies. This product may contain inactive ingredients, which||
6010|073|P|can cause allergic reactions or other problems. Talk to your||
6010|074|P|pharmacist for more details.||
6010|075|P|   Before using this medication, tell your doctor or pharmacist||
6010|076|P|your medical history, especially of: certain structural heart||
6010|077|P|problem (aortic stenosis), liver disease, kidney disease.||
6010|078|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6010|079|P|can make you more dizzy. Do not drive, use machinery, or do||
6010|080|P|anything that needs alertness until you can do it safely. Limit||
6010|081|P|alcoholic beverages. Talk to your doctor if you are using||
6010|082|P|marijuana (cannabis).||
6010|083|P|   Before having surgery, tell your doctor or dentist about all||
6010|084|P|the products you use (including prescription drugs,||
6010|085|P|nonprescription drugs, and herbal products).||
6010|086|P|   During pregnancy, this medication should be used only when||
6010|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
6010|088|P|   It is unknown if this medication passes into breast milk.||
6010|089|P|Consult your doctor before breastfeeding.||
6010|090|B|||
6010|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6010|092|I|medications work or increase your risk for serious side effects.||
6010|093|I|This document does not contain all possible drug interactions.||
6010|094|I|Keep a list of all the products you use (including||
6010|095|I|prescription/nonprescription drugs and herbal products) and share||
6010|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
6010|097|I|the dosage of any medicines without your doctor's approval.||
6010|098|I|   Other medications can affect the removal of isradipine from||
6010|099|I|your body, which may affect how isradipine works. Examples||
6010|100|I|include cimetidine, azole antifungals (such as itraconazole),||
6010|101|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
6010|102|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
6010|103|I|as phenytoin), among others.||
6010|104|I|   Some products have ingredients that could raise your blood||
6010|105|I|pressure. Tell your pharmacist what products you are using, and||
6010|106|I|ask how to use them safely (especially cough-and-cold products,||
6010|107|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
6010|108|B|||
6010|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6010|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6010|111|O|poison control center right away. US residents can call||
6010|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6010|113|B|||
6010|114|N|NOTES:  Do not share this medication with others. Talk with your||
6010|115|N|doctor about making changes to your lifestyle that may help this||
6010|116|N|medication work better (such as stress reduction programs,||
6010|117|N|exercise, and dietary changes).||
6010|118|N|   Lab and/or medical tests (such as liver function, blood||
6010|119|N|pressure, electrocardiograms) may be done while you are taking||
6010|120|N|this medication. Keep all medical and lab appointments. Consult||
6010|121|N|your doctor for more details.||
6010|122|N|   There are different types of this medication available. They||
6010|123|N|may not have the same effects. Do not change types without||
6010|124|N|consulting your doctor or pharmacist.||
6010|125|N|   Have your blood pressure checked regularly while taking this||
6010|126|N|medication. Discuss with your doctor how to monitor your own||
6010|127|N|blood pressure.||
6010|128|B|||
6010|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6010|130|D|remember. If it is near the time of the next dose, skip the||
6010|131|D|missed dose. Take your next dose at the regular time. Do not||
6010|132|D|double the dose to catch up.||
6010|133|B|||
6010|134|R|STORAGE:  Store at room temperature away from light and moisture.||
6010|135|R|Do not store in the bathroom. Keep all medications away from||
6010|136|R|children and pets.||
6010|137|R|   Do not flush medications down the toilet or pour them into a||
6010|138|R|drain unless instructed to do so. Properly discard this product||
6010|139|R|when it is expired or no longer needed. Consult your pharmacist||
6010|140|R|or local waste disposal company.||
6010|141|B|||
6010|142|M|MEDICAL ALERT:  Your condition can cause complications in a||
6010|143|M|medical emergency. For information about enrolling in MedicAlert,||
6010|144|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6010|145|B|||
6010|146|A|Information last revised May 2024.||
6010|147|A|Copyright(c) 2025 First Databank, Inc.||
6010|148|B|||
6012|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6012|002|Z|does NOT have all possible information about this product. This||
6012|003|Z|information does not assure that this product is safe, effective,||
6012|004|Z|or appropriate for you. This information is not individual||
6012|005|Z|medical advice and does not substitute for the advice of your||
6012|006|Z|health care professional. Always ask your health care||
6012|007|Z|professional for complete information about this product and your||
6012|008|Z|specific health needs.||
6012|009|B|||
6012|010|T|PSEUDOEPHEDRINE - ORAL||
6012|011|F|(sue-doh-eff-ED-rin)||
6012|012|B|||
6012|013|C|COMMON BRAND NAME(S): Afrinol, Sudafed||
6012|014|B|||
6012|015|U|USES:  Pseudoephedrine is used for the temporary relief of stuffy||
6012|016|U|nose and sinus pain/pressure caused by infection (such as the||
6012|017|U|common cold, flu) or other breathing illnesses (such as hay||
6012|018|U|fever, allergies, bronchitis). Pseudoephedrine is a decongestant||
6012|019|U|(sympathomimetic). It works by narrowing the blood vessels to||
6012|020|U|decrease swelling and congestion.||
6012|021|U|   If you are self-treating with this medication, it is important||
6012|022|U|to read the manufacturer's package instructions carefully so you||
6012|023|U|know when to consult your doctor or pharmacist. (See also||
6012|024|U|Precautions section.)||
6012|025|U|   Cough-and-cold products have not been shown to be safe or||
6012|026|U|effective in children younger than 6 years. Do not use this||
6012|027|U|product in children younger than 6 years unless specifically||
6012|028|U|directed by the doctor. Long-acting tablets/capsules are not||
6012|029|U|recommended for use in children younger than 12 years. Ask your||
6012|030|U|doctor or pharmacist for more details about using your product||
6012|031|U|safely.||
6012|032|U|   These products do not cure or shorten the length of the common||
6012|033|U|cold and may cause serious side effects. To decrease the risk for||
6012|034|U|serious side effects, carefully follow all dosage directions. Do||
6012|035|U|not use this product to make a child sleepy. Do not give other||
6012|036|U|cough-and-cold medication that might contain the same or similar||
6012|037|U|decongestants (see also Drug Interactions section). Ask the||
6012|038|U|doctor or pharmacist about other ways to relieve cough and cold||
6012|039|U|symptoms (such as drinking enough fluids, using a humidifier or||
6012|040|U|saline nose drops/spray).||
6012|041|B|||
6012|042|V|OTHER USES:  This section contains uses of this drug that are not||
6012|043|V|listed in the approved professional labeling for the drug but||
6012|044|V|that may be prescribed by your health care professional. Use this||
6012|045|V|drug for a condition that is listed in this section only if it||
6012|046|V|has been so prescribed by your health care professional.||
6012|047|V|   Your doctor may direct you to use pseudoephedrine to decrease||
6012|048|V|pain and swelling in the ear or to help "open up" the ear canal||
6012|049|V|when there is a change in air pressure (such as during air||
6012|050|V|travel, underwater diving). Follow your doctor's directions||
6012|051|V|carefully.||
6012|052|B|||
6012|053|H|HOW TO USE:  If you are taking the over-the-counter product to||
6012|054|H|self-treat, read all directions on the product package before||
6012|055|H|taking this medication. If you have any questions, ask your||
6012|056|H|doctor or pharmacist. If your doctor has prescribed this||
6012|057|H|medication, take it as directed.||
6012|058|H|   Take this medication by mouth with or without food, usually||
6012|059|H|every 4 to 6 hours, as directed by the product package or by your||
6012|060|H|doctor. Do not take more than 4 doses in a day. The dosage is||
6012|061|H|based on your age, medical condition, and response to treatment.||
6012|062|H|Do not increase your dose or take this drug more often than||
6012|063|H|directed. Do not take more of this medication than recommended||
6012|064|H|for your age.||
6012|065|H|   If you are using the chewable tablets, chew each tablet well||
6012|066|H|and swallow. If you are using the liquid form of this medication,||
6012|067|H|measure the dose carefully using a special measuring device/cup.||
6012|068|H|Do not use a household spoon because you may not get the correct||
6012|069|H|dose.||
6012|070|H|   There are many brands and forms of pseudoephedrine available.||
6012|071|H|Some tablets should be swallowed with plenty of water. Check your||
6012|072|H|product package for specific directions. Read the dosing||
6012|073|H|instructions carefully for each product because the amount of||
6012|074|H|pseudoephedrine may be different between products. Do not take||
6012|075|H|more pseudoephedrine than recommended.||
6012|076|H|   Caffeine can increase the side effects of this medication.||
6012|077|H|Avoid drinking large amounts of beverages containing caffeine||
6012|078|H|(coffee, tea, colas), eating large amounts of chocolate, or||
6012|079|H|taking nonprescription products that contain caffeine.||
6012|080|H|   Tell your doctor if your symptoms do not get better after 7||
6012|081|H|days or if they get worse or return, or if you have a headache||
6012|082|H|that doesn't go away, fever, or rash. If you think you may have a||
6012|083|H|serious medical problem, get medical help right away.||
6012|084|B|||
6012|085|S|SIDE EFFECTS:  Nausea, vomiting, trouble sleeping, dizziness,||
6012|086|S|headache, or nervousness may occur. If any of these effects last||
6012|087|S|or get worse, tell your doctor or pharmacist promptly. Stop||
6012|088|S|taking this medication and tell your doctor promptly if you have||
6012|089|S|dizziness, nervousness, or trouble sleeping.||
6012|090|S|   If your doctor has directed you to use this medication,||
6012|091|S|remember that your doctor has judged that the benefit to you is||
6012|092|S|greater than the risk of side effects. Many people using this||
6012|093|S|medication do not have serious side effects.||
6012|094|S|   This medication may raise your blood pressure. Check your||
6012|095|S|blood pressure regularly and tell your doctor if the results are||
6012|096|S|high.||
6012|097|S|   Stop taking this medication and tell your doctor right away if||
6012|098|S|you have any serious side effects, including:||
6012|099|S|fast/irregular/pounding heartbeat, mental/mood changes (such as||
6012|100|S|anxiety, confusion, restlessness), shaking (tremor), difficulty||
6012|101|S|urinating.||
6012|102|S|   A very serious allergic reaction to this drug is rare.||
6012|103|S|However, get medical help right away if you notice any symptoms||
6012|104|S|of a serious allergic reaction, including: rash, itching/swelling||
6012|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6012|106|S|breathing.||
6012|107|S|   This is not a complete list of possible side effects. If you||
6012|108|S|notice other effects not listed above, contact your doctor or||
6012|109|S|pharmacist.||
6012|110|S|   In the US -||
6012|111|S|   Call your doctor for medical advice about side effects. You||
6012|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6012|113|S|www.fda.gov/medwatch.||
6012|114|S|   In Canada - Call your doctor for medical advice about side||
6012|115|S|effects. You may report side effects to Health Canada at||
6012|116|S|1-866-234-2345.||
6012|117|B|||
6012|118|P|PRECAUTIONS:  Before taking pseudoephedrine, tell your doctor or||
6012|119|P|pharmacist if you are allergic to it; or if you have any other||
6012|120|P|allergies. Also tell your doctor if you have had negative||
6012|121|P|reactions to other sympathomimetics (such as ephedrine,||
6012|122|P|phenylephrine). This product may contain inactive ingredients,||
6012|123|P|which can cause allergic reactions or other problems. Talk to||
6012|124|P|your pharmacist for more details.||
6012|125|P|   If you have any of the following health problems, consult your||
6012|126|P|doctor or pharmacist before using this product: diabetes, a||
6012|127|P|certain eye condition (glaucoma), heart problems (such as heart||
6012|128|P|attack, chest pain, heart failure), fast/irregular heart beat,||
6012|129|P|high blood pressure, kidney disease, overactive thyroid||
6012|130|P|(hyperthyroidism), difficulty urinating (such as due to enlarged||
6012|131|P|prostate).||
6012|132|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6012|133|P|can make you more dizzy. Do not drive, use machinery, or do||
6012|134|P|anything that needs alertness until you can do it safely. Limit||
6012|135|P|alcoholic beverages. Talk to your doctor if you are using||
6012|136|P|marijuana (cannabis).||
6012|137|P|   Liquid products, chewable tablets, or dissolving||
6012|138|P|tablets/strips may contain sugar and/or aspartame. Liquid||
6012|139|P|products may also contain alcohol. Caution is advised if you have||
6012|140|P|diabetes, alcohol dependence, liver disease, phenylketonuria||
6012|141|P|(PKU), or any other condition that requires you to limit/avoid||
6012|142|P|these substances in your diet. Ask your doctor or pharmacist||
6012|143|P|about using this product safely.||
6012|144|P|   Before having surgery, tell your doctor or dentist about all||
6012|145|P|the products you use (including prescription drugs,||
6012|146|P|nonprescription drugs, and herbal products).||
6012|147|P|   Older adults may be more sensitive to the side effects of this||
6012|148|P|drug, especially fast/irregular heartbeat, dizziness, problems||
6012|149|P|urinating, trouble sleeping, or confusion.||
6012|150|P|   Children may be more sensitive to the effects of this||
6012|151|P|medication, especially restlessness.||
6012|152|P|   During pregnancy, this medication should be used only when||
6012|153|P|clearly needed. Discuss the risks and benefits with your doctor.||
6012|154|P|   Pseudoephedrine passes into breast milk. Consult your doctor||
6012|155|P|before breastfeeding.||
6012|156|B|||
6012|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6012|158|I|medications work or increase your risk for serious side effects.||
6012|159|I|This document does not contain all possible drug interactions.||
6012|160|I|Keep a list of all the products you use (including||
6012|161|I|prescription/nonprescription drugs and herbal products) and share||
6012|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
6012|163|I|the dosage of any medicines without your doctor's approval.||
6012|164|I|   Taking MAO inhibitors with this medication may cause a serious||
6012|165|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
6012|166|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
6012|167|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
6012|168|I|selegiline, tranylcypromine) during treatment with this||
6012|169|I|medication. Most MAO inhibitors should also not be taken for two||
6012|170|I|weeks before treatment with this medication. Ask your doctor when||
6012|171|I|to start or stop taking this medication.||
6012|172|I|   Check the labels on all your medicines (such as allergy or||
6012|173|I|cough-and-cold products) because they may contain similar||
6012|174|I|ingredients (decongestants such as phenylephrine). Ask your||
6012|175|I|pharmacist about using those products safely.||
6012|176|B|||
6012|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6012|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6012|179|O|poison control center right away. US residents can call||
6012|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6012|181|O|Symptoms of overdose may include: slow/shallow breathing,||
6012|182|O|hallucinations, seizures.||
6012|183|B|||
6012|184|N|NOTES:  Keep all medical and lab appointments.||
6012|185|B|||
6012|186|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6012|187|D|remember. If it is near the time of the next dose, skip the||
6012|188|D|missed dose. Take your next dose at the regular time. Do not||
6012|189|D|double the dose to catch up.||
6012|190|B|||
6012|191|R|STORAGE:  Different brands of this medication have different||
6012|192|R|storage needs. Check the product package for instructions on how||
6012|193|R|to store your brand, or ask your pharmacist. Keep all medications||
6012|194|R|away from children and pets.||
6012|195|R|   Do not flush medications down the toilet or pour them into a||
6012|196|R|drain unless instructed to do so. Properly discard this product||
6012|197|R|when it is expired or no longer needed. Consult your pharmacist||
6012|198|R|or local waste disposal company.||
6012|199|B|||
6012|200|A|Information last revised November 2025.||
6012|201|A|Copyright(c) 2025 First Databank, Inc.||
6012|202|B|||
6013|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6013|002|Z|does NOT have all possible information about this product. This||
6013|003|Z|information does not assure that this product is safe, effective,||
6013|004|Z|or appropriate for you. This information is not individual||
6013|005|Z|medical advice and does not substitute for the advice of your||
6013|006|Z|health care professional. Always ask your health care||
6013|007|Z|professional for complete information about this product and your||
6013|008|Z|specific health needs.||
6013|009|B|||
6013|010|T|METOPROLOL/HYDROCHLOROTHIAZIDE - ORAL||
6013|011|F|(met-oh-PRO-lol/HYE-droe-KLOR-oh-THYE-a-zide)||
6013|012|B|||
6013|013|C|COMMON BRAND NAME(S): Lopressor HCT||
6013|014|B|||
6013|015|W|WARNING:  Do not stop taking this medication without consulting||
6013|016|W|your doctor. Some conditions may become worse when you suddenly||
6013|017|W|stop this drug. Some people who have suddenly stopped taking||
6013|018|W|similar drugs have had chest pain, heart attack, and irregular||
6013|019|W|heartbeat. If your doctor decides you should no longer use this||
6013|020|W|drug, your doctor may direct you to gradually decrease your dose||
6013|021|W|over 1 to 2 weeks.||
6013|022|W|   When gradually stopping this medication, it is recommended||
6013|023|W|that you temporarily limit physical activity to decrease strain||
6013|024|W|on the heart. Get medical help right away if you develop chest||
6013|025|W|pain/tightness/pressure, chest pain spreading to the||
6013|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
6013|027|W|fast/irregular heartbeat.||
6013|028|B|||
6013|029|U|USES:  This medication is used to treat high blood pressure||
6013|030|U|(hypertension). Lowering high blood pressure helps prevent||
6013|031|U|strokes, heart attacks, and kidney problems. This product||
6013|032|U|contains 2 medications, metoprolol and hydrochlorothiazide.||
6013|033|U|Metoprolol belongs to a class of drugs known as beta blockers. It||
6013|034|U|works by keeping certain natural chemicals such as epinephrine||
6013|035|U|from acting on the heart and blood vessels. This effect lowers||
6013|036|U|the heart rate, blood pressure, and strain on the heart.||
6013|037|U|Hydrochlorothiazide is a "water pill" (diuretic) and causes your||
6013|038|U|body to get rid of extra salt and water. This effect may increase||
6013|039|U|the amount of urine you make when you first start the medication.||
6013|040|B|||
6013|041|V|OTHER USES:  This section contains uses of this drug that are not||
6013|042|V|listed in the approved professional labeling for the drug but||
6013|043|V|that may be prescribed by your health care professional. Use this||
6013|044|V|drug for a condition that is listed in this section only if it||
6013|045|V|has been so prescribed by your health care professional.||
6013|046|V|   This drug may also be used for heart failure.||
6013|047|B|||
6013|048|H|HOW TO USE:  See also Warning section.||
6013|049|H|   Take this medication by mouth with or right after a meal as||
6013|050|H|directed by your doctor, usually 1 or 2 times daily.||
6013|051|H|   If you take this drug too close to bedtime, you may need to||
6013|052|H|wake up to urinate. It is best to take this medication at least 4||
6013|053|H|hours before your bedtime. Consult your doctor or pharmacist if||
6013|054|H|you have questions about when to take this medication.||
6013|055|H|   The dosage is based on your medical condition and response to||
6013|056|H|treatment.||
6013|057|H|   Use this medication regularly to get the most benefit from it.||
6013|058|H|To help you remember, take it at the same time(s) each day.||
6013|059|H|   It may take several weeks before you get the full benefit of||
6013|060|H|this medication. Keep taking this medication even if you feel||
6013|061|H|well. Most people with high blood pressure do not feel sick.||
6013|062|H|   If you also take certain drugs to lower your cholesterol (bile||
6013|063|H|acid-binding resins such as cholestyramine or colestipol), take||
6013|064|H|this product at least 4 hours before or at least 4 to 6 hours||
6013|065|H|after these medications.||
6013|066|H|   Tell your doctor if your condition does not get better or if||
6013|067|H|it gets worse (your blood pressure readings remain high or||
6013|068|H|increase).||
6013|069|B|||
6013|070|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
6013|071|S|   Dizziness, lightheadedness, drowsiness, headache, slow||
6013|072|S|heartbeat, tiredness, or diarrhea may occur. Some people may have||
6013|073|S|decreased sexual ability. If any of these effects last or get||
6013|074|S|worse, tell your doctor or pharmacist promptly.||
6013|075|S|   To reduce the risk of dizziness and lightheadedness, get up||
6013|076|S|slowly when rising from a sitting or lying position.||
6013|077|S|   This product may reduce blood flow to your hands and feet,||
6013|078|S|causing them to feel cold. Smoking may worsen this effect. Dress||
6013|079|S|warmly and avoid tobacco use.||
6013|080|S|   Remember that this medication has been prescribed because your||
6013|081|S|doctor has judged that the benefit to you is greater than the||
6013|082|S|risk of side effects. Many people using this medication do not||
6013|083|S|have serious side effects.||
6013|084|S|   This product may cause dehydration and electrolyte imbalance.||
6013|085|S|Tell your doctor right away if you have any symptoms of||
6013|086|S|dehydration or electrolyte imbalance, including unusual dry||
6013|087|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
6013|088|S|heartbeat, or confusion.||
6013|089|S|   Tell your doctor right away if you have any serious side||
6013|090|S|effects, including: very slow/irregular heartbeat, fainting,||
6013|091|S|mental/mood changes (such as depression, mood swings), toe/joint||
6013|092|S|pain, blue fingers/toes, decrease in vision, eye pain, signs of||
6013|093|S|kidney problems (such as change in the amount of urine).||
6013|094|S|   Although this medication may be used to treat heart failure,||
6013|095|S|some people may rarely develop new or worsening symptoms of heart||
6013|096|S|failure. Tell your doctor right away if you experience any of||
6013|097|S|these serious side effects: shortness of breath, swelling||
6013|098|S|ankles/feet, unusual tiredness, unusual/sudden weight gain.||
6013|099|S|   A very serious allergic reaction to this drug is rare.||
6013|100|S|However, get medical help right away if you notice any symptoms||
6013|101|S|of a serious allergic reaction, including: rash, itching/swelling||
6013|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6013|103|S|breathing.||
6013|104|S|   This is not a complete list of possible side effects. If you||
6013|105|S|notice other effects not listed above, contact your doctor or||
6013|106|S|pharmacist.||
6013|107|S|   In the US -||
6013|108|S|   Call your doctor for medical advice about side effects. You||
6013|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6013|110|S|www.fda.gov/medwatch.||
6013|111|S|   In Canada - Call your doctor for medical advice about side||
6013|112|S|effects. You may report side effects to Health Canada at||
6013|113|S|1-866-234-2345.||
6013|114|B|||
6013|115|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
6013|116|P|pharmacist if you are allergic to metoprolol or||
6013|117|P|hydrochlorothiazide; or if you have any other allergies. This||
6013|118|P|product may contain inactive ingredients, which can cause||
6013|119|P|allergic reactions or other problems. Talk to your pharmacist for||
6013|120|P|more details.||
6013|121|P|   Before using this medication, tell your doctor or pharmacist||
6013|122|P|your medical history, especially of: certain types of heart||
6013|123|P|rhythm problems (such as a slow heartbeat, second- or||
6013|124|P|third-degree atrioventricular block, sick sinus syndrome), blood||
6013|125|P|circulation problems (such as Raynaud's disease, peripheral||
6013|126|P|vascular disease), breathing problems (such as asthma, chronic||
6013|127|P|bronchitis, emphysema), liver disease, kidney disease (such as||
6013|128|P|anuria), lupus, serious allergic reactions including those||
6013|129|P|needing treatment with epinephrine, gout, a certain muscle/nerve||
6013|130|P|disease (myasthenia gravis), skin cancer.||
6013|131|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6013|132|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6013|133|P|machinery, or do anything that needs alertness until you can do||
6013|134|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
6013|135|P|are using marijuana (cannabis).||
6013|136|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
6013|137|P|and cause you to feel lightheaded. Tell your doctor if you have||
6013|138|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
6013|139|P|of fluids unless your doctor tells you not to.||
6013|140|P|   This medication may reduce the potassium levels in your blood.||
6013|141|P|Ask your doctor about adding potassium to your diet. Your doctor||
6013|142|P|may prescribe a potassium supplement.||
6013|143|P|   This product may prevent the fast/pounding heartbeat you would||
6013|144|P|usually feel when your blood sugar level falls too low||
6013|145|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
6013|146|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
6013|147|P|blood sugar level, such as dizziness and sweating, are not||
6013|148|P|affected by this drug.||
6013|149|P|   If you have diabetes, this product may make it harder to||
6013|150|P|control your blood sugar levels. Check your blood sugar levels||
6013|151|P|regularly as directed by your doctor. Tell your doctor right away||
6013|152|P|if you have symptoms of high blood sugar such as increased||
6013|153|P|thirst/urination. Your doctor may need to adjust your diabetes||
6013|154|P|medication, exercise program, or diet.||
6013|155|P|   This medication may make you more sensitive to the sun. It may||
6013|156|P|also increase your risk for skin cancer, especially if you take||
6013|157|P|it for a long time. Limit your time in the sun. Avoid tanning||
6013|158|P|booths and sunlamps. Use sunscreen and wear protective clothing||
6013|159|P|when outdoors. Tell your doctor right away if you get sunburned,||
6013|160|P|have skin blisters/redness, or notice new or changed moles/skin||
6013|161|P|lesions.||
6013|162|P|   Before having surgery, tell your doctor or dentist about all||
6013|163|P|the products you use (including prescription drugs,||
6013|164|P|nonprescription drugs, and herbal products).||
6013|165|P|   Older adults may be more sensitive to the side effects of this||
6013|166|P|drug, especially dizziness.||
6013|167|P|   During pregnancy, this medication should be used only when||
6013|168|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
6013|169|P|benefits with your doctor.||
6013|170|P|   Metoprolol and hydrochlorothiazide pass into breast milk, but||
6013|171|P|are unlikely to harm a nursing infant. Consult your doctor before||
6013|172|P|breastfeeding.||
6013|173|B|||
6013|174|I|DRUG INTERACTIONS:  See also How to Use section.||
6013|175|I|   Drug interactions may change how your medications work or||
6013|176|I|increase your risk for serious side effects. This document does||
6013|177|I|not contain all possible drug interactions. Keep a list of all||
6013|178|I|the products you use (including prescription/nonprescription||
6013|179|I|drugs and herbal products) and share it with your doctor and||
6013|180|I|pharmacist. Do not start, stop, or change the dosage of any||
6013|181|I|medicines without your doctor's approval.||
6013|182|I|   Some products that may interact with this drug are:||
6013|183|I|dofetilide, fingolimod, lithium.||
6013|184|I|   Other medications can affect the removal of metoprolol from||
6013|185|I|your body, which may affect how this product works. Examples||
6013|186|I|include lumefantrine, propafenone, quinidine, SSRI||
6013|187|I|antidepressants (such as fluoxetine, paroxetine), St. John's||
6013|188|I|wort, among others.||
6013|189|I|   Some products have ingredients that could raise your heart||
6013|190|I|rate or blood pressure or worsen your heart failure. Tell your||
6013|191|I|pharmacist what products you are using, and ask how to use them||
6013|192|I|safely (especially cough-and-cold products, diet aids, or NSAIDs||
6013|193|I|such as ibuprofen/naproxen).||
6013|194|I|   This product may interfere with certain lab tests (including||
6013|195|I|parathyroid, tyramine, and phentolamine), possibly causing false||
6013|196|I|test results. Make sure lab personnel and all your doctors know||
6013|197|I|you use this drug.||
6013|198|B|||
6013|199|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6013|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6013|201|O|poison control center right away. US residents can call||
6013|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6013|203|O|Symptoms of overdose may include: severe dizziness, fainting,||
6013|204|O|very slow heartbeat, trouble breathing.||
6013|205|B|||
6013|206|N|NOTES:  Do not share this medication with others.||
6013|207|N|   Talk with your doctor about making changes to your lifestyle||
6013|208|N|that may help this medication work better (such as stress||
6013|209|N|reduction programs, exercise, and dietary changes).||
6013|210|N|   Lab and/or medical tests (including kidney/liver function,||
6013|211|N|blood mineral levels such as potassium, skin exams, cholesterol||
6013|212|N|levels) should be done while you are taking this medication. Keep||
6013|213|N|all medical and lab appointments. Consult your doctor for more||
6013|214|N|details.||
6013|215|N|   Check your blood pressure and pulse (heart rate) regularly||
6013|216|N|while taking this medication. Learn how to check your own blood||
6013|217|N|pressure and pulse at home, and share the results with your||
6013|218|N|doctor.||
6013|219|B|||
6013|220|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6013|221|D|remember. If it is near the time of the next dose, skip the||
6013|222|D|missed dose. Take your next dose at the regular time. Do not||
6013|223|D|double the dose to catch up.||
6013|224|B|||
6013|225|R|STORAGE:  Store at room temperature away from light and moisture.||
6013|226|R|Do not store in the bathroom. Keep all medications away from||
6013|227|R|children and pets.||
6013|228|R|   Do not flush medications down the toilet or pour them into a||
6013|229|R|drain unless instructed to do so. Properly discard this product||
6013|230|R|when it is expired or no longer needed. Consult your pharmacist||
6013|231|R|or local waste disposal company.||
6013|232|B|||
6013|233|A|Information last revised March 2025.||
6013|234|A|Copyright(c) 2025 First Databank, Inc.||
6013|235|B|||
6019|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6019|002|Z|does NOT have all possible information about this product. This||
6019|003|Z|information does not assure that this product is safe, effective,||
6019|004|Z|or appropriate for you. This information is not individual||
6019|005|Z|medical advice and does not substitute for the advice of your||
6019|006|Z|health care professional. Always ask your health care||
6019|007|Z|professional for complete information about this product and your||
6019|008|Z|specific health needs.||
6019|009|B|||
6019|010|T|TOPIRAMATE - ORAL||
6019|011|F|(toe-PEER-uh-mate)||
6019|012|B|||
6019|013|C|COMMON BRAND NAME(S): Topamax||
6019|014|B|||
6019|015|U|USES:  Topiramate is used alone or with other medications to||
6019|016|U|prevent and control seizures (epilepsy). This medication is also||
6019|017|U|used to prevent migraine headaches and decrease how often you get||
6019|018|U|them. Topiramate will not treat a migraine headache once it||
6019|019|U|occurs. If you get a migraine headache, treat it as directed by||
6019|020|U|your doctor (such as by taking pain medication, lying down in a||
6019|021|U|dark room).||
6019|022|U|   Topiramate is known as an anticonvulsant or antiepileptic||
6019|023|U|drug.||
6019|024|B|||
6019|025|V|OTHER USES:  This section contains uses of this drug that are not||
6019|026|V|listed in the approved professional labeling for the drug but||
6019|027|V|that may be prescribed by your health care professional. Use this||
6019|028|V|drug for a condition that is listed in this section only if it||
6019|029|V|has been so prescribed by your health care professional.||
6019|030|V|   This drug may also be used for binge eating disorder (BED).||
6019|031|B|||
6019|032|H|HOW TO USE:  Read the Medication Guide and, if available, the||
6019|033|H|Patient Information Leaflet provided by your pharmacist before||
6019|034|H|you start taking topiramate and each time you get a refill. If||
6019|035|H|you have any questions, ask your doctor or pharmacist.||
6019|036|H|   Take this medication by mouth with or without food as directed||
6019|037|H|by your doctor, usually twice daily. Swallow the tablets whole||
6019|038|H|since breaking them may leave a bitter taste. To prevent kidney||
6019|039|H|stones from forming, drink plenty of liquids while taking this||
6019|040|H|medication unless your doctor instructs you otherwise.||
6019|041|H|   The dosage is based on your medical condition and response to||
6019|042|H|treatment. Children's dosage is also based on weight. Your doctor||
6019|043|H|will gradually increase your dose to reduce your risk of side||
6019|044|H|effects. For some conditions, you may start treatment with||
6019|045|H|topiramate once daily at bedtime and slowly increase your dose to||
6019|046|H|twice a day. It may take several weeks or months to reach the||
6019|047|H|best dose for you and to get the full benefit from this||
6019|048|H|medication.||
6019|049|H|   Take this medication regularly to get the most benefit from||
6019|050|H|it. To help you remember, take it at the same times each day. Do||
6019|051|H|not stop taking this medication without consulting your doctor.||
6019|052|H|Some conditions may become worse when this drug is suddenly||
6019|053|H|stopped. Your dose may need to be gradually decreased.||
6019|054|H|   Tell your doctor if your condition lasts or if it gets worse.||
6019|055|B|||
6019|056|S|SIDE EFFECTS:  Tiredness, drowsiness, dizziness, loss of||
6019|057|S|coordination, nervousness, tingling of the hands/feet, loss of||
6019|058|S|appetite, changes in how foods taste, diarrhea, or weight loss||
6019|059|S|may occur. If any of these effects last or get worse, tell your||
6019|060|S|doctor or pharmacist promptly.||
6019|061|S|   Remember that this medication has been prescribed because your||
6019|062|S|doctor has judged that the benefit to you is greater than the||
6019|063|S|risk of side effects. Many people using this medication do not||
6019|064|S|have serious side effects.||
6019|065|S|   Tell your doctor right away if you have any serious side||
6019|066|S|effects, including: bone pain, signs of kidney stones (such as||
6019|067|S|severe back/side/abdominal/groin pain, fever, chills,||
6019|068|S|painful/frequent urination, bloody/pink urine), unusual||
6019|069|S|bleeding/bruising, confusion, difficulty concentrating, memory||
6019|070|S|loss, difficulty speaking.||
6019|071|S|   Get medical help right away if you have any very serious side||
6019|072|S|effects, including: rapid breathing, fast/slow/irregular||
6019|073|S|heartbeat.||
6019|074|S|   A small number of people who take anticonvulsants for any||
6019|075|S|condition (such as seizures, bipolar disorder, pain) may||
6019|076|S|experience depression, suicidal thoughts/attempts, or other||
6019|077|S|mental/mood problems. Tell your doctor right away if you or your||
6019|078|S|family/caregiver notice any unusual/sudden changes in your mood,||
6019|079|S|thoughts, or behavior including signs of depression, suicidal||
6019|080|S|thoughts/attempts, thoughts about harming yourself.||
6019|081|S|   Rarely, topiramate may cause a very serious eye problem,||
6019|082|S|usually within 1 month of starting treatment. This eye problem||
6019|083|S|can lead to permanent blindness. Get medical help right away if||
6019|084|S|any of these side effects occur: sudden vision changes (such as||
6019|085|S|decreased vision, blurred vision), eye pain/redness.||
6019|086|S|   This medication can rarely cause a serious metabolic problem||
6019|087|S|(high amount of ammonia in the blood), especially if you are also||
6019|088|S|taking valproic acid. Tell your doctor right away if you||
6019|089|S|experience sudden/unexplained tiredness, vomiting, or mental||
6019|090|S|changes (such as decreased alertness).||
6019|091|S|   A very serious allergic reaction to this drug is rare.||
6019|092|S|However, get medical help right away if you notice any symptoms||
6019|093|S|of a serious allergic reaction, including: rash, itching/swelling||
6019|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6019|095|S|breathing.||
6019|096|S|   This is not a complete list of possible side effects. If you||
6019|097|S|notice other effects not listed above, contact your doctor or||
6019|098|S|pharmacist.||
6019|099|S|   In the US -||
6019|100|S|   Call your doctor for medical advice about side effects. You||
6019|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6019|102|S|www.fda.gov/medwatch.||
6019|103|S|   In Canada - Call your doctor for medical advice about side||
6019|104|S|effects. You may report side effects to Health Canada at||
6019|105|S|1-866-234-2345.||
6019|106|B|||
6019|107|P|PRECAUTIONS:  Before taking topiramate, tell your doctor or||
6019|108|P|pharmacist if you are allergic to it; or if you have any other||
6019|109|P|allergies. This product may contain inactive ingredients, which||
6019|110|P|can cause allergic reactions or other problems. Talk to your||
6019|111|P|pharmacist for more details.||
6019|112|P|   Before using this medication, tell your doctor or pharmacist||
6019|113|P|your medical history, especially of: a certain eye problem||
6019|114|P|(narrow angle glaucoma), kidney problems (such as kidney stones),||
6019|115|P|liver problems, mental/mood problems (such as depression,||
6019|116|P|thoughts of suicide), lung/breathing problems, a certain||
6019|117|P|metabolic imbalance (metabolic acidosis), long-term diarrhea, a||
6019|118|P|diet high in fat and low in carbohydrates (ketogenic diet),||
6019|119|P|brittle bones (osteoporosis).||
6019|120|P|   This drug may make you dizzy or drowsy or impair your||
6019|121|P|judgment. Alcohol or marijuana (cannabis) can worsen these||
6019|122|P|effects. Do not drive, use machinery, or do anything that needs||
6019|123|P|alertness until you can do it safely. Avoid alcoholic beverages.||
6019|124|P|Talk to your doctor if you are using marijuana (cannabis).||
6019|125|P|   This medication may make you sweat less, making you more||
6019|126|P|likely to get heat stroke. Avoid doing things that may cause you||
6019|127|P|to overheat, such as hard work or exercise in hot weather, or||
6019|128|P|using hot tubs. When the weather is hot, drink a lot of fluids||
6019|129|P|and dress lightly. If you overheat, quickly look for a place to||
6019|130|P|cool down and rest. Get medical help right away if you have a||
6019|131|P|fever that does not go away, mental/mood changes, headache, or||
6019|132|P|dizziness.||
6019|133|P|   Before having surgery, tell your doctor or dentist about all||
6019|134|P|the products you use (including prescription drugs,||
6019|135|P|nonprescription drugs, and herbal products).||
6019|136|P|   Children may be more sensitive to the side effects of this||
6019|137|P|drug, especially weakened bones, slowed growth rate, and||
6019|138|P|decreased sweating. Consult your doctor or pharmacist for more||
6019|139|P|details.||
6019|140|P|   Older adults may be more sensitive to the side effects of this||
6019|141|P|drug, especially dizziness. Dizziness can increase the risk of||
6019|142|P|falling.||
6019|143|P|   During pregnancy, this medication should be used only when||
6019|144|P|clearly needed. It may harm an unborn baby. Discuss the use of||
6019|145|P|reliable forms of birth control with your doctor (see also Drug||
6019|146|P|Interactions section). If you are planning pregnancy, become||
6019|147|P|pregnant, or think you may be pregnant, immediately talk to your||
6019|148|P|doctor about the benefits and risks of using this medication||
6019|149|P|during pregnancy. If you are taking this drug to treat seizures,||
6019|150|P|note that untreated seizures are a serious condition that can||
6019|151|P|harm both a pregnant woman and her unborn baby, so do not stop||
6019|152|P|taking this medication unless directed by your doctor.||
6019|153|P|   This medication passes into breast milk and may have||
6019|154|P|undesirable effects on a nursing infant. Consult your doctor||
6019|155|P|before breastfeeding.||
6019|156|B|||
6019|157|I|DRUG INTERACTIONS:  See also Side Effects section.||
6019|158|I|   Drug interactions may change how your medications work or||
6019|159|I|increase your risk for serious side effects. This document does||
6019|160|I|not contain all possible drug interactions. Keep a list of all||
6019|161|I|the products you use (including prescription/nonprescription||
6019|162|I|drugs and herbal products) and share it with your doctor and||
6019|163|I|pharmacist. Do not start, stop, or change the dosage of any||
6019|164|I|medicines without your doctor's approval.||
6019|165|I|   A product that may interact with this drug is: orlistat.||
6019|166|I|   This medication may decrease the effectiveness of hormonal||
6019|167|I|birth control such as pills, patch, or ring. This could cause||
6019|168|I|pregnancy. Discuss with your doctor or pharmacist if you should||
6019|169|I|use reliable backup birth control methods while using this||
6019|170|I|medication. Also tell your doctor if you have any new spotting or||
6019|171|I|breakthrough bleeding, because these may be signs that your birth||
6019|172|I|control is not working well.||
6019|173|I|   Tell your doctor or pharmacist if you are taking other||
6019|174|I|products that cause drowsiness including alcohol, marijuana||
6019|175|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
6019|176|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
6019|177|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
6019|178|I|codeine).||
6019|179|I|   Check the labels on all your medicines (such as allergy or||
6019|180|I|cough-and-cold products) because they may contain ingredients||
6019|181|I|that cause drowsiness. Ask your pharmacist about using those||
6019|182|I|products safely.||
6019|183|B|||
6019|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6019|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6019|186|O|poison control center right away. US residents can call||
6019|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6019|188|O|Symptoms of overdose may include: severe drowsiness, loss of||
6019|189|O|consciousness.||
6019|190|B|||
6019|191|N|NOTES:  Do not share this medication with others.||
6019|192|N|   Lab and/or medical tests (such as eye exams, bicarbonate blood||
6019|193|N|level) should be done while you are taking this medication. Keep||
6019|194|N|all medical and lab appointments.||
6019|195|B|||
6019|196|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6019|197|D|remember. If it is within 6 hours of the next dose, skip the||
6019|198|D|missed dose. Take your next dose at the regular time. Do not||
6019|199|D|double the dose to catch up. If you miss more than one dose, call||
6019|200|D|your doctor for advice.||
6019|201|B|||
6019|202|R|STORAGE:  Store at room temperature away from light and moisture.||
6019|203|R|Do not store in the bathroom. Keep all medications away from||
6019|204|R|children and pets.||
6019|205|R|   Do not flush medications down the toilet or pour them into a||
6019|206|R|drain unless instructed to do so. Properly discard this product||
6019|207|R|when it is expired or no longer needed. Consult your pharmacist||
6019|208|R|or local waste disposal company.||
6019|209|B|||
6019|210|M|MEDICAL ALERT:  Your condition can cause complications in a||
6019|211|M|medical emergency. For information about enrolling in MedicAlert,||
6019|212|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6019|213|B|||
6019|214|A|Information last revised September 2024.||
6019|215|A|Copyright(c) 2025 First Databank, Inc.||
6019|216|B|||
6021|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6021|002|Z|does NOT have all possible information about this product. This||
6021|003|Z|information does not assure that this product is safe, effective,||
6021|004|Z|or appropriate for you. This information is not individual||
6021|005|Z|medical advice and does not substitute for the advice of your||
6021|006|Z|health care professional. Always ask your health care||
6021|007|Z|professional for complete information about this product and your||
6021|008|Z|specific health needs.||
6021|009|B|||
6021|010|T|BECLOMETHASONE - NASAL||
6021|011|F|(BE-kloe-METH-a-sone)||
6021|012|B|||
6021|013|C|COMMON BRAND NAME(S): Beconase Aq, Vancenase Aq||
6021|014|B|||
6021|015|U|USES:  Beclomethasone is used to prevent and treat seasonal and||
6021|016|U|year-round allergy symptoms (such as stuffy/runny nose, itchy||
6021|017|U|eyes/nose/throat, sneezing). It may be used to treat symptoms||
6021|018|U|(such as stuffy/runny nose) caused by other triggers (such as||
6021|019|U|cigarette smoke, perfumes). It is also used to prevent the return||
6021|020|U|of growths in the nose (nasal polyps) after removal by surgery.||
6021|021|U|Beclomethasone belongs to a class of drugs known as||
6021|022|U|corticosteroids. It works by reducing swelling (inflammation) in||
6021|023|U|the nasal passages.||
6021|024|B|||
6021|025|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
6021|026|H|your pharmacist before you start using this medication and each||
6021|027|H|time you get a refill. Follow the illustrated directions for the||
6021|028|H|proper use of this medication. If you have any questions, ask||
6021|029|H|your doctor or pharmacist.||
6021|030|H|   Use this medication in the nose as directed by your doctor,||
6021|031|H|usually 1 or 2 sprays in each nostril twice a day. Avoid spraying||
6021|032|H|this medication in your eyes. Gently blow your nose before using||
6021|033|H|this drug. Shake the container well before each use. Follow the||
6021|034|H|instructions to properly prime the spray pump.||
6021|035|H|   To use the spray, first remove the safety clip and plastic||
6021|036|H|cap. Close one nostril by pressing it with your finger. Tilt your||
6021|037|H|head slightly forward and, keeping the bottle upright, carefully||
6021|038|H|insert the nasal applicator into the other nostril. Press down||
6021|039|H|firmly on the pump to deliver the prescribed number of sprays. Do||
6021|040|H|not spray directly onto the middle wall of your nose (nasal||
6021|041|H|septum). Breathe in gently through your nose and out through your||
6021|042|H|mouth. Repeat in the other nostril. Wipe the applicator tip and||
6021|043|H|replace the plastic cap and safety clip. Avoid blowing your nose||
6021|044|H|for 15 minutes after using this medication.||
6021|045|H|   The dosage is based on your medical condition and response to||
6021|046|H|treatment. Younger children may need a smaller dose and help from||
6021|047|H|an adult to use this medication properly. Use this medication||
6021|048|H|regularly in order to get the most benefit from it. To help you||
6021|049|H|remember, use it at the same times each day. Do not increase your||
6021|050|H|dose or use it more often than directed.||
6021|051|H|   This medication does not work right away. Some people will||
6021|052|H|feel this medication working within 3 days, but it may take up to||
6021|053|H|2 weeks before the full benefit of this drug takes effect. Ask||
6021|054|H|your doctor or pharmacist if you should also use other||
6021|055|H|medications (such as nose drops/spray, allergy drugs taken by||
6021|056|H|mouth) along with this drug until it takes full effect.||
6021|057|H|   Keep track of the number of sprays used from the bottle.||
6021|058|H|Discard the bottle after you have used the number of sprays||
6021|059|H|specified on the manufacturer's package. Do not pour any||
6021|060|H|remaining medication into another container. Follow the package||
6021|061|H|instructions to unblock the spray tip if needed and to clean the||
6021|062|H|spray bottle.||
6021|063|H|   Tell your doctor if your condition does not get better after 3||
6021|064|H|weeks or if it gets worse.||
6021|065|B|||
6021|066|S|SIDE EFFECTS:  Nose/throat dryness or irritation, sneezing,||
6021|067|S|nosebleeds, nausea, and unpleasant taste/smell may occur. If any||
6021|068|S|of these side effects last or get worse, tell your doctor or||
6021|069|S|pharmacist promptly.||
6021|070|S|   Remember that this medication has been prescribed because your||
6021|071|S|doctor has judged that the benefit to you is greater than the||
6021|072|S|risk of side effects. Many people using this medication do not||
6021|073|S|have serious side effects.||
6021|074|S|   Tell your doctor right away if you have any serious side||
6021|075|S|effects, including: loss of taste or smell, pain/sores in your||
6021|076|S|nose.||
6021|077|S|   Rarely, it is possible that corticosteroids given in the nose||
6021|078|S|will be absorbed into the bloodstream. This can lead to side||
6021|079|S|effects of too much corticosteroid. These side effects are more||
6021|080|S|likely in children and people who use this medication for a long||
6021|081|S|time and in high doses. Tell your doctor right away if any of the||
6021|082|S|following side effects occur: unusual/extreme tiredness, weight||
6021|083|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
6021|084|S|vision problems.||
6021|085|S|   Corticosteroids may weaken the body's ability to fight||
6021|086|S|infections. This may make you more likely to get a serious||
6021|087|S|(rarely fatal) infection or make any infection you have worse.||
6021|088|S|This effect might also rarely occur with corticosteroids inhaled||
6021|089|S|through the nose (such as beclomethasone). The risk may be||
6021|090|S|increased if high doses are used, especially when used for a long||
6021|091|S|time. Tell your doctor right away if you have any signs of||
6021|092|S|infection (such as sore throat that doesn't go away, fever,||
6021|093|S|chills, white patches inside the nose or on the back of the||
6021|094|S|throat).||
6021|095|S|   A very serious allergic reaction to this drug is rare.||
6021|096|S|However, get medical help right away if you notice any symptoms||
6021|097|S|of a serious allergic reaction, including: rash, itching/swelling||
6021|098|S|(especially of the face/tongue/throat), severe dizziness,||
6021|099|S|wheezing/trouble breathing.||
6021|100|S|   This is not a complete list of possible side effects. If you||
6021|101|S|notice other effects not listed above, contact your doctor or||
6021|102|S|pharmacist.||
6021|103|S|   In the US -||
6021|104|S|   Call your doctor for medical advice about side effects. You||
6021|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6021|106|S|www.fda.gov/medwatch.||
6021|107|S|   In Canada - Call your doctor for medical advice about side||
6021|108|S|effects. You may report side effects to Health Canada at||
6021|109|S|1-866-234-2345.||
6021|110|B|||
6021|111|P|PRECAUTIONS:  Before using nasal beclomethasone, tell your doctor||
6021|112|P|or pharmacist if you are allergic to it; or if you have any other||
6021|113|P|allergies. This product may contain inactive ingredients, which||
6021|114|P|can cause allergic reactions or other problems. Talk to your||
6021|115|P|pharmacist for more details.||
6021|116|P|   Before using this medication, tell your doctor or pharmacist||
6021|117|P|your medical history, especially of: eye problems (such as||
6021|118|P|glaucoma, cataracts), infections (including tuberculosis), recent||
6021|119|P|nose problems (such as injury, ulcers, surgery).||
6021|120|P|   Stay away from anyone who has an infection that may easily||
6021|121|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
6021|122|P|doctor if you have been exposed to an infection or for more||
6021|123|P|details.||
6021|124|P|   Rarely, using corticosteroid medications for a long time can||
6021|125|P|make it more difficult for your body to respond to physical||
6021|126|P|stress. Before having surgery or emergency treatment, or if you||
6021|127|P|get a serious illness/injury, tell your doctor or dentist that||
6021|128|P|you are using this medication or have used this medication within||
6021|129|P|the past few months.||
6021|130|P|   Before having surgery, tell your doctor or dentist about all||
6021|131|P|the products you use (including prescription drugs,||
6021|132|P|nonprescription drugs, and herbal products).||
6021|133|P|   Though it is unlikely, this medication may temporarily slow||
6021|134|P|down a child's growth if used for a long time. See the doctor||
6021|135|P|regularly so your child's height can be checked.||
6021|136|P|   During pregnancy, this medication should be used only when||
6021|137|P|clearly needed. Discuss the risks and benefits with your doctor.||
6021|138|P|   It is unknown if this medication passes into breast milk.||
6021|139|P|Consult your doctor before breastfeeding.||
6021|140|B|||
6021|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6021|142|I|medications work or increase your risk for serious side effects.||
6021|143|I|This document does not contain all possible drug interactions.||
6021|144|I|Keep a list of all the products you use (including||
6021|145|I|prescription/nonprescription drugs and herbal products) and share||
6021|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
6021|147|I|the dosage of any medicines without your doctor's approval.||
6021|148|I|   Check all prescription medicine labels carefully since similar||
6021|149|I|medications (other corticosteroids such as prednisone) may||
6021|150|I|increase your risk of side effects if taken together with this||
6021|151|I|drug. Ask your doctor or pharmacist if you have any questions||
6021|152|I|about your medications.||
6021|153|B|||
6021|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6021|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6021|156|O|poison control center right away. US residents can call||
6021|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6021|158|B|||
6021|159|N|NOTES:  Do not share this medication with others.||
6021|160|N|   If you use this medication for a long time, lab and/or medical||
6021|161|N|tests (such as nose exams, height measurement in children) may be||
6021|162|N|done while you are using this medication. Keep all medical and||
6021|163|N|lab appointments. Consult your doctor for more details.||
6021|164|N|   Avoid substances (such as pollen, pet dander, dust mites,||
6021|165|N|mold, and smoke) that can worsen allergy symptoms.||
6021|166|B|||
6021|167|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6021|168|D|If it is near the time of the next dose, skip the missed dose.||
6021|169|D|Use your next dose at the regular time. Do not double the dose to||
6021|170|D|catch up.||
6021|171|B|||
6021|172|R|STORAGE:  Store at room temperature with the safety clip and||
6021|173|R|protective cap in place. Keep container upright. Keep all||
6021|174|R|medications away from children and pets.||
6021|175|R|   Do not flush medications down the toilet or pour them into a||
6021|176|R|drain unless instructed to do so. Properly discard this product||
6021|177|R|when it is expired or no longer needed. Consult your pharmacist||
6021|178|R|or local waste disposal company.||
6021|179|B|||
6021|180|A|Information last revised May 2025.||
6021|181|A|Copyright(c) 2025 First Databank, Inc.||
6021|182|B|||
6022|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6022|002|Z|does NOT have all possible information about this product. This||
6022|003|Z|information does not assure that this product is safe, effective,||
6022|004|Z|or appropriate for you. This information is not individual||
6022|005|Z|medical advice and does not substitute for the advice of your||
6022|006|Z|health care professional. Always ask your health care||
6022|007|Z|professional for complete information about this product and your||
6022|008|Z|specific health needs.||
6022|009|B|||
6022|010|T|WARFARIN - ORAL||
6022|011|F|(WARF-uh-rin)||
6022|012|B|||
6022|013|C|COMMON BRAND NAME(S): Coumadin, Jantoven||
6022|014|B|||
6022|015|W|WARNING:  Warfarin can cause very serious (possibly fatal)||
6022|016|W|bleeding. This is more likely to occur when you first start||
6022|017|W|taking this medication or if you take too much warfarin.||
6022|018|W|   To decrease your risk for bleeding, your doctor or other||
6022|019|W|health care provider will monitor you closely and check your lab||
6022|020|W|results (INR test) to make sure you are not taking too much||
6022|021|W|warfarin. Keep all medical and lab appointments. Tell your doctor||
6022|022|W|right away if you notice any signs of serious bleeding. See also||
6022|023|W|Side Effects section.||
6022|024|B|||
6022|025|U|USES:  This medication is used to treat blood clots (such as in||
6022|026|U|deep vein thrombosis-DVT or pulmonary embolus-PE) and/or to||
6022|027|U|prevent new clots from forming in your body. Preventing harmful||
6022|028|U|blood clots helps to reduce the risk of a stroke or heart attack.||
6022|029|U|Conditions that increase your risk of developing blood clots||
6022|030|U|include a certain type of irregular heart rhythm (atrial||
6022|031|U|fibrillation), heart valve replacement, certain heart valve||
6022|032|U|problems (such as rheumatic heart disease), recent heart attack,||
6022|033|U|and certain surgeries (such as hip/knee replacement).||
6022|034|U|   Warfarin is commonly called a "blood thinner," but the more||
6022|035|U|correct term is "anticoagulant." It helps to keep blood flowing||
6022|036|U|smoothly in your body by decreasing the amount of certain||
6022|037|U|substances (clotting proteins) in your blood.||
6022|038|B|||
6022|039|H|HOW TO USE:  Read the Medication Guide provided by your||
6022|040|H|pharmacist before you start taking warfarin and each time you get||
6022|041|H|a refill. If you have any questions, ask your doctor or||
6022|042|H|pharmacist.||
6022|043|H|   Take this medication by mouth with or without food as directed||
6022|044|H|by your doctor or other health care professional, usually once a||
6022|045|H|day. It is very important to take it exactly as directed. Do not||
6022|046|H|increase the dose, take it more often, or stop using it unless||
6022|047|H|directed by your doctor.||
6022|048|H|   The dosage is based on your medical condition, lab tests (such||
6022|049|H|as INR), and response to treatment. Your doctor or other health||
6022|050|H|care provider will monitor you closely while you are taking this||
6022|051|H|medication to determine the right dose for you.||
6022|052|H|   Use this medication regularly to get the most benefit from it.||
6022|053|H|To help you remember, take it at the same time each day.||
6022|054|H|   It is important to eat a balanced, consistent diet while||
6022|055|H|taking warfarin. Some foods can affect how warfarin works in your||
6022|056|H|body and may affect your treatment and dose. Avoid sudden large||
6022|057|H|increases or decreases in your intake of foods high in vitamin K||
6022|058|H|(such as broccoli, cauliflower, cabbage, brussels sprouts, kale,||
6022|059|H|spinach, and other green leafy vegetables, liver, green tea,||
6022|060|H|certain vitamin supplements). If you are trying to lose weight,||
6022|061|H|check with your doctor before you try to go on a diet.||
6022|062|H|   Since this drug can be absorbed through the skin and lungs and||
6022|063|H|may harm an unborn baby, women who are pregnant or who may become||
6022|064|H|pregnant should not handle this medication or breathe the dust||
6022|065|H|from the tablets.||
6022|066|B|||
6022|067|S|SIDE EFFECTS:  Nausea, loss of appetite, or stomach/abdominal||
6022|068|S|pain may occur. If any of these effects last or get worse, tell||
6022|069|S|your doctor or pharmacist promptly.||
6022|070|S|   Remember that this medication has been prescribed because your||
6022|071|S|doctor has judged that the benefit to you is greater than the||
6022|072|S|risk of side effects. Many people using this medication do not||
6022|073|S|have serious side effects.||
6022|074|S|   This medication can cause serious bleeding if it affects your||
6022|075|S|blood clotting proteins too much (shown by unusually high INR lab||
6022|076|S|results). Even if your doctor stops your medication, this risk of||
6022|077|S|bleeding can continue for up to a week. Tell your doctor right||
6022|078|S|away if you have any signs of serious bleeding, including:||
6022|079|S|nosebleeds that happen often or don't stop, unusual||
6022|080|S|pain/swelling/discomfort, unusual/easy bruising, prolonged||
6022|081|S|bleeding from cuts or gums, unusually heavy/prolonged menstrual||
6022|082|S|flow, pink/dark urine, coughing up blood, vomit that is bloody or||
6022|083|S|looks like coffee grounds, severe headache, dizziness/fainting,||
6022|084|S|unusual tiredness/weakness, bloody/black/tarry stools, chest||
6022|085|S|pain, shortness of breath, difficulty swallowing.||
6022|086|S|   Tell your doctor right away if you have any serious side||
6022|087|S|effects, including: nausea/vomiting that doesn't stop, severe||
6022|088|S|stomach/abdominal pain, yellowing eyes/skin.||
6022|089|S|   This drug rarely has caused very serious (possibly fatal)||
6022|090|S|problems if its effects lead to small blood clots (usually at the||
6022|091|S|beginning of treatment). This can lead to severe skin/tissue||
6022|092|S|damage that may require surgery or amputation if left untreated.||
6022|093|S|Patients with certain blood conditions (protein C or S||
6022|094|S|deficiency) may be at greater risk. Get medical help right away||
6022|095|S|if any of these rare but serious side effects occur:||
6022|096|S|painful/red/purplish patches on the skin (such as on the toe,||
6022|097|S|breast, abdomen), signs of kidney problems (such as change in the||
6022|098|S|amount of urine), vision changes, confusion, trouble speaking,||
6022|099|S|weakness on one side of the body.||
6022|100|S|   A very serious allergic reaction to this drug is rare.||
6022|101|S|However, get medical help right away if you notice any symptoms||
6022|102|S|of a serious allergic reaction, including: rash, itching/swelling||
6022|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6022|104|S|breathing.||
6022|105|S|   This is not a complete list of possible side effects. If you||
6022|106|S|notice other effects not listed above, contact your doctor or||
6022|107|S|pharmacist.||
6022|108|S|   In the US -||
6022|109|S|   Call your doctor for medical advice about side effects. You||
6022|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6022|111|S|www.fda.gov/medwatch.||
6022|112|S|   In Canada - Call your doctor for medical advice about side||
6022|113|S|effects. You may report side effects to Health Canada at||
6022|114|S|1-866-234-2345.||
6022|115|B|||
6022|116|P|PRECAUTIONS:  Before taking warfarin, tell your doctor or||
6022|117|P|pharmacist if you are allergic to it; or if you have any other||
6022|118|P|allergies. This product may contain inactive ingredients, which||
6022|119|P|can cause allergic reactions or other problems. Talk to your||
6022|120|P|pharmacist for more details.||
6022|121|P|   Before using this medication, tell your doctor or pharmacist||
6022|122|P|your medical history, especially of: blood disorders (such as||
6022|123|P|anemia, hemophilia), bleeding problems (such as bleeding of the||
6022|124|P|stomach/intestines, bleeding in the brain), blood vessel||
6022|125|P|disorders (such as aneurysms), recent major injury/surgery,||
6022|126|P|kidney disease, liver disease, alcohol use, mental/mood disorders||
6022|127|P|(including memory problems), frequent falls/injuries.||
6022|128|P|   It is important that all your doctors and dentists know that||
6022|129|P|you take warfarin. Before having surgery or any medical/dental||
6022|130|P|procedures, tell your doctor or dentist that you are taking this||
6022|131|P|medication and about all the products you use (including||
6022|132|P|prescription drugs, nonprescription drugs, and herbal products).||
6022|133|P|   Avoid getting injections into the muscles. If you must have an||
6022|134|P|injection into a muscle (for example, a flu shot), it should be||
6022|135|P|given in the arm. This way, it will be easier to check for||
6022|136|P|bleeding and/or apply pressure bandages.||
6022|137|P|   This medication may cause stomach bleeding. Daily use of||
6022|138|P|alcohol while using this medicine will increase your risk for||
6022|139|P|stomach bleeding and may also affect how this medication works.||
6022|140|P|Limit alcoholic beverages. Ask your doctor or pharmacist about||
6022|141|P|how much alcohol you may safely drink.||
6022|142|P|   If you have not been eating well, if you have an illness or||
6022|143|P|infection that causes fever, vomiting, or diarrhea for more than||
6022|144|P|2 days, or if you start using any antibiotic medications, contact||
6022|145|P|your doctor or pharmacist right away because these conditions can||
6022|146|P|affect how warfarin works.||
6022|147|P|   This medication can cause heavy bleeding. To lower the chance||
6022|148|P|of getting cut, bruised, or injured, use great caution with sharp||
6022|149|P|objects like safety razors and nail cutters. Use an electric||
6022|150|P|razor when shaving and a soft toothbrush when brushing your||
6022|151|P|teeth. Avoid activities such as contact sports. If you fall or||
6022|152|P|injure yourself, especially if you hit your head, call your||
6022|153|P|doctor right away. Your doctor may need to check you.||
6022|154|P|   The FDA has stated that generic warfarin products are||
6022|155|P|interchangeable. However, consult your doctor or pharmacist||
6022|156|P|before switching warfarin products. Be careful not to take more||
6022|157|P|than one medication that contains warfarin unless specifically||
6022|158|P|directed by the doctor or health care provider who is monitoring||
6022|159|P|your warfarin treatment.||
6022|160|P|   Older adults may be at greater risk for bleeding while using||
6022|161|P|this drug.||
6022|162|P|   Tell your doctor if you are pregnant or plan to become||
6022|163|P|pregnant. You should not become pregnant while using warfarin.||
6022|164|P|Warfarin may harm an unborn baby. Your doctor should order a||
6022|165|P|pregnancy test before you start this medication. Ask about||
6022|166|P|reliable forms of birth control while using this medication and||
6022|167|P|for at least 1 month after the last dose. If you become pregnant,||
6022|168|P|talk to your doctor right away about the risks and benefits of||
6022|169|P|this medication. If you are planning pregnancy, discuss a plan||
6022|170|P|for managing your condition with your doctor before you become||
6022|171|P|pregnant. Your doctor may switch the type of medication you use||
6022|172|P|during pregnancy.||
6022|173|P|   Since this drug can be absorbed through the skin and lungs and||
6022|174|P|may harm an unborn baby, women who are pregnant or who may become||
6022|175|P|pregnant should not handle this medication or breathe the dust||
6022|176|P|from the tablets.||
6022|177|P|   Very small amounts of this medication may pass into breast||
6022|178|P|milk but is unlikely to harm a nursing infant. Consult your||
6022|179|P|doctor before breastfeeding.||
6022|180|B|||
6022|181|I|DRUG INTERACTIONS:  See also How to Use section.||
6022|182|I|   Drug interactions may change how your medications work or||
6022|183|I|increase your risk for serious side effects. This document does||
6022|184|I|not contain all possible drug interactions. Keep a list of all||
6022|185|I|the products you use (including prescription/nonprescription||
6022|186|I|drugs and herbal products) and share it with your doctor and||
6022|187|I|pharmacist. Do not start, stop, or change the dosage of any||
6022|188|I|medicines without your doctor's approval.||
6022|189|I|   Warfarin interacts with many prescription, nonprescription,||
6022|190|I|vitamin, and herbal products. This includes medications that are||
6022|191|I|applied to the skin or inside the vagina or rectum. The following||
6022|192|I|interactions listed do not contain all possible drug||
6022|193|I|interactions. The interactions with warfarin usually result in an||
6022|194|I|increase or decrease in the "blood-thinning" (anticoagulant)||
6022|195|I|effect. Your doctor or other health care professional should||
6022|196|I|closely monitor you to prevent serious bleeding or clotting||
6022|197|I|problems. While you are taking warfarin, it is very important to||
6022|198|I|tell your doctor or pharmacist of any changes in medications,||
6022|199|I|vitamins, or herbal products that you are taking.||
6022|200|I|   Some products that may interact with this drug include:||
6022|201|I|imatinib, marijuana (cannabis), dronabinol, mifepristone, other||
6022|202|I|drugs that can cause bleeding/bruising (including "blood||
6022|203|I|thinners" such as apixaban/dabigatran).||
6022|204|I|   Aspirin, aspirin-like drugs (salicylates), and nonsteroidal||
6022|205|I|anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen,||
6022|206|I|celecoxib) may have effects similar to warfarin. These drugs may||
6022|207|I|increase the risk of bleeding problems if taken during treatment||
6022|208|I|with warfarin. Carefully check all prescription/nonprescription||
6022|209|I|product labels (including drugs applied to the skin such as||
6022|210|I|pain-relieving creams) since the products may contain NSAIDs or||
6022|211|I|salicylates. Talk to your doctor about using a different||
6022|212|I|medication (such as acetaminophen) to treat pain/fever. However,||
6022|213|I|if your doctor has told you to take low-dose aspirin to prevent||
6022|214|I|heart attack or stroke (usually 81-162 milligrams a day), you||
6022|215|I|should keep taking the aspirin unless your doctor tells you not||
6022|216|I|to. Ask your doctor or pharmacist for more details.||
6022|217|I|   This medication may interfere with certain lab tests (such as||
6022|218|I|theophylline levels), possibly causing false test results. Make||
6022|219|I|sure lab personnel and all your doctors know you use this drug.||
6022|220|B|||
6022|221|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6022|222|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6022|223|O|poison control center right away. US residents can call||
6022|224|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6022|225|O|Symptoms of overdose may include: bloody/black/tarry stools,||
6022|226|O|pink/dark urine, unusual/prolonged bleeding.||
6022|227|B|||
6022|228|N|NOTES:  Do not share this medication with others.||
6022|229|N|   Lab and/or medical tests (such as INR, complete blood count)||
6022|230|N|must be done while you are taking this medication. Keep all||
6022|231|N|medical and lab appointments. Consult your doctor for more||
6022|232|N|details.||
6022|233|B|||
6022|234|D|MISSED DOSE:  For the best possible benefit, do not miss any||
6022|235|D|doses. If you miss a dose, take it as soon as you remember. If||
6022|236|D|you don't remember until the next day, skip the missed dose. Take||
6022|237|D|your next dose at the regular time. Do not double the dose to||
6022|238|D|catch up because this could increase your risk for bleeding. Keep||
6022|239|D|a record of missed doses to give to your doctor or pharmacist.||
6022|240|D|Contact your doctor or pharmacist if you miss 2 or more doses in||
6022|241|D|a row.||
6022|242|B|||
6022|243|R|STORAGE:  Store at room temperature away from light and moisture.||
6022|244|R|Do not store in the bathroom. Keep all medications away from||
6022|245|R|children and pets.||
6022|246|R|   Do not flush medications down the toilet or pour them into a||
6022|247|R|drain unless instructed to do so. Properly discard this product||
6022|248|R|when it is expired or no longer needed. Consult your pharmacist||
6022|249|R|or local waste disposal company.||
6022|250|B|||
6022|251|M|MEDICAL ALERT:  Your condition can cause complications in a||
6022|252|M|medical emergency. For information about enrolling in MedicAlert,||
6022|253|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6022|254|B|||
6022|255|A|Information last revised June 2025.||
6022|256|A|Copyright(c) 2025 First Databank, Inc.||
6022|257|B|||
6024|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6024|002|Z|does NOT have all possible information about this product. This||
6024|003|Z|information does not assure that this product is safe, effective,||
6024|004|Z|or appropriate for you. This information is not individual||
6024|005|Z|medical advice and does not substitute for the advice of your||
6024|006|Z|health care professional. Always ask your health care||
6024|007|Z|professional for complete information about this product and your||
6024|008|Z|specific health needs.||
6024|009|B|||
6024|010|T|CLONIDINE 0.025 MG - ORAL||
6024|011|F|(KLON-i-deen)||
6024|012|B|||
6024|013|U|USES:  This medication is used by women to help reduce a certain||
6024|014|U|symptom of menopause (hot flashes).||
6024|015|B|||
6024|016|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6024|017|H|from your pharmacist before you start taking clonidine and each||
6024|018|H|time you get a refill. If you have any questions, ask your doctor||
6024|019|H|or pharmacist.||
6024|020|H|   Take this medication by mouth with or without food as directed||
6024|021|H|by your doctor, usually twice daily.||
6024|022|H|   The dosage is based on your medical condition and response to||
6024|023|H|treatment.||
6024|024|H|   Use this medication regularly to get the most benefit from it.||
6024|025|H|To help you remember, take it at the same times each day.||
6024|026|H|   Do not stop taking this medication without consulting your||
6024|027|H|doctor. You may experience symptoms such as nervousness,||
6024|028|H|agitation, shaking, and headache. A rapid rise in blood pressure||
6024|029|H|may also occur if the drug is suddenly stopped. The risk is||
6024|030|H|greater if you have used this drug for a long time or in high||
6024|031|H|doses, or if you are also taking a beta blocker (such as||
6024|032|H|atenolol). There have also been rare reports of severe, possibly||
6024|033|H|fatal reactions (such as stroke) from stopping this drug too||
6024|034|H|quickly. It is important that you do not run out of clonidine or||
6024|035|H|miss any doses. Tell your doctor or pharmacist right away if you||
6024|036|H|are unable to take the medication (for example, due to vomiting).||
6024|037|H|To prevent any reactions while you are stopping treatment with||
6024|038|H|this drug, your doctor may reduce your dose gradually. Consult||
6024|039|H|your doctor or pharmacist for more details. Report any new or||
6024|040|H|worsening symptoms right away.||
6024|041|H|   It may take 2 to 4 weeks before you get the full benefit of||
6024|042|H|this medication. Tell your doctor if your symptoms do not get||
6024|043|H|better or if they get worse.||
6024|044|B|||
6024|045|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, dry mouth,||
6024|046|S|or constipation may occur. If any of these effects last or get||
6024|047|S|worse, tell your doctor or pharmacist promptly.||
6024|048|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
6024|049|S|chips, chew (sugarless) gum, drink water, or use a saliva||
6024|050|S|substitute.||
6024|051|S|   To reduce the risk of dizziness and lightheadedness, get up||
6024|052|S|slowly when rising from a sitting or lying position.||
6024|053|S|   Remember that this medication has been prescribed because your||
6024|054|S|doctor has judged that the benefit to you is greater than the||
6024|055|S|risk of side effects. Many people using this medication do not||
6024|056|S|have serious side effects.||
6024|057|S|   Tell your doctor right away if you have any serious side||
6024|058|S|effects, including: fainting, slow/irregular heartbeat,||
6024|059|S|mental/mood changes (such as irritability, depression).||
6024|060|S|   A very serious allergic reaction to this drug is rare.||
6024|061|S|However, get medical help right away if you notice any symptoms||
6024|062|S|of a serious allergic reaction, including: rash, itching/swelling||
6024|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6024|064|S|breathing.||
6024|065|S|   This is not a complete list of possible side effects. If you||
6024|066|S|notice other effects not listed above, contact your doctor or||
6024|067|S|pharmacist.||
6024|068|S|   In the US -||
6024|069|S|   Call your doctor for medical advice about side effects. You||
6024|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6024|071|S|www.fda.gov/medwatch.||
6024|072|S|   In Canada - Call your doctor for medical advice about side||
6024|073|S|effects. You may report side effects to Health Canada at||
6024|074|S|1-866-234-2345.||
6024|075|B|||
6024|076|P|PRECAUTIONS:  Before taking clonidine, tell your doctor or||
6024|077|P|pharmacist if you are allergic to it (including having a rash||
6024|078|P|while using clonidine patches); or if you have any other||
6024|079|P|allergies. This product may contain inactive ingredients, which||
6024|080|P|can cause allergic reactions or other problems. Talk to your||
6024|081|P|pharmacist for more details.||
6024|082|P|   Before using this medication, tell your doctor or pharmacist||
6024|083|P|your medical history, especially of: heart rhythm problems (such||
6024|084|P|as slow/irregular heartbeat), stroke, low blood pressure, kidney||
6024|085|P|disease.||
6024|086|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6024|087|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6024|088|P|machinery, or do anything that needs alertness until you can do||
6024|089|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6024|090|P|are using marijuana (cannabis).||
6024|091|P|   Before having surgery, tell your doctor or dentist about all||
6024|092|P|the products you use (including prescription drugs,||
6024|093|P|nonprescription drugs, and herbal products).||
6024|094|P|   Contact lens wearers may need to use wetting eye drops since||
6024|095|P|this medication can cause dry eyes.||
6024|096|P|   Older adults may be more sensitive to the side effects of this||
6024|097|P|product, especially dizziness, or drowsiness. These side effects||
6024|098|P|may increase the risk of falling.||
6024|099|P|   During pregnancy, this medication should be used only when||
6024|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
6024|101|P|   This drug passes into breast milk and may have undesirable||
6024|102|P|effects on a nursing infant. Consult your doctor before||
6024|103|P|breastfeeding.||
6024|104|B|||
6024|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6024|106|I|medications work or increase your risk for serious side effects.||
6024|107|I|This document does not contain all possible drug interactions.||
6024|108|I|Keep a list of all the products you use (including||
6024|109|I|prescription/nonprescription drugs and herbal products) and share||
6024|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
6024|111|I|the dosage of any medicines without your doctor's approval.||
6024|112|I|   Tell your doctor or pharmacist if you are taking other||
6024|113|I|products that cause drowsiness including alcohol, marijuana||
6024|114|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
6024|115|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
6024|116|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
6024|117|I|codeine).||
6024|118|I|   Check the labels on all your medicines (such as allergy or||
6024|119|I|cough-and-cold products) because they may contain ingredients||
6024|120|I|that cause drowsiness. Ask your pharmacist about using those||
6024|121|I|products safely.||
6024|122|B|||
6024|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6024|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6024|125|O|poison control center right away. US residents can call||
6024|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6024|127|O|Symptoms of overdose may include: severe dizziness/drowsiness,||
6024|128|O|fainting, slow/irregular heartbeat, slow/shallow breathing,||
6024|129|O|seizures.||
6024|130|B|||
6024|131|N|NOTES:  Do not share this medication with others.||
6024|132|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
6024|133|N|should be done while you are taking this medication. Keep all||
6024|134|N|medical and lab appointments. Consult your doctor for more||
6024|135|N|details.||
6024|136|B|||
6024|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6024|138|D|remember. If it is near the time of the next dose, skip the||
6024|139|D|missed dose. Take your next dose at the regular time. Do not||
6024|140|D|double the dose to catch up. If you miss 2 or more doses in a||
6024|141|D|row, contact your doctor right away.||
6024|142|B|||
6024|143|R|STORAGE:  Store at room temperature away from light and moisture.||
6024|144|R|Do not store in the bathroom. Keep all medications away from||
6024|145|R|children and pets.||
6024|146|R|   Do not flush medications down the toilet or pour them into a||
6024|147|R|drain unless instructed to do so. Properly discard this product||
6024|148|R|when it is expired or no longer needed. Consult your pharmacist||
6024|149|R|or local waste disposal company.||
6024|150|B|||
6024|151|A|Information last revised November 2024.||
6024|152|A|Copyright(c) 2025 First Databank, Inc.||
6024|153|B|||
6026|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6026|002|Z|does NOT have all possible information about this product. This||
6026|003|Z|information does not assure that this product is safe, effective,||
6026|004|Z|or appropriate for you. This information is not individual||
6026|005|Z|medical advice and does not substitute for the advice of your||
6026|006|Z|health care professional. Always ask your health care||
6026|007|Z|professional for complete information about this product and your||
6026|008|Z|specific health needs.||
6026|009|B|||
6026|010|T|METHYLERGONOVINE - ORAL||
6026|011|F|(METH-ill-er-go-NO-veen)||
6026|012|B|||
6026|013|C|COMMON BRAND NAME(S): Methergine||
6026|014|B|||
6026|015|U|USES:  This medication is used after childbirth to help stop||
6026|016|U|bleeding from the uterus. Methylergonovine belongs to a class of||
6026|017|U|drugs known as ergot alkaloids. It works by increasing the rate||
6026|018|U|and strength of contractions and the stiffness of the uterus||
6026|019|U|muscles. These effects help to decrease bleeding.||
6026|020|B|||
6026|021|H|HOW TO USE:  Take this medication by mouth with or without food||
6026|022|H|as directed by your doctor, usually 3 to 4 times daily for up to||
6026|023|H|1 week after delivery.||
6026|024|H|   Dosage is based on your medical condition and response to||
6026|025|H|treatment.||
6026|026|H|   Use this medication regularly to get the most benefit from it.||
6026|027|H|To help you remember, take it at the same times each day.||
6026|028|H|   Tell your doctor if your condition lasts or gets worse.||
6026|029|B|||
6026|030|S|SIDE EFFECTS:  Headache, nausea, vomiting, or dizziness may||
6026|031|S|occur. If any of these effects last or get worse, tell your||
6026|032|S|doctor or pharmacist promptly.||
6026|033|S|   Remember that this medication has been prescribed because your||
6026|034|S|doctor has judged that the benefit to you is greater than the||
6026|035|S|risk of side effects. Many people using this medication do not||
6026|036|S|have serious side effects.||
6026|037|S|   Tell your doctor right away if you have any serious side||
6026|038|S|effects, including: fast/slow heartbeat, shortness of breath,||
6026|039|S|cold hands/feet, pain/redness/swelling of arms or legs.||
6026|040|S|   Get medical help right away if you have any very serious side||
6026|041|S|effects, including: chest pain, vision changes, confusion,||
6026|042|S|seizures.||
6026|043|S|   A very serious allergic reaction to this drug is rare.||
6026|044|S|However, get medical help right away if you notice any symptoms||
6026|045|S|of a serious allergic reaction, including: rash, itching/swelling||
6026|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6026|047|S|breathing.||
6026|048|S|   This is not a complete list of possible side effects. If you||
6026|049|S|notice other effects not listed above, contact your doctor or||
6026|050|S|pharmacist.||
6026|051|S|   In the US -||
6026|052|S|   Call your doctor for medical advice about side effects. You||
6026|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6026|054|S|www.fda.gov/medwatch.||
6026|055|S|   In Canada - Call your doctor for medical advice about side||
6026|056|S|effects. You may report side effects to Health Canada at||
6026|057|S|1-866-234-2345.||
6026|058|B|||
6026|059|P|PRECAUTIONS:  Before taking methylergonovine, tell your doctor or||
6026|060|P|pharmacist if you are allergic to it; or to similar ergot||
6026|061|P|alkaloids (such as ergonovine); or if you have any other||
6026|062|P|allergies. This product may contain inactive ingredients, which||
6026|063|P|can cause allergic reactions or other problems. Talk to your||
6026|064|P|pharmacist for more details.||
6026|065|P|   Before using this medication, tell your doctor or pharmacist||
6026|066|P|your medical history, especially of: kidney disease, liver||
6026|067|P|disease, high blood pressure, heart disease (such as venoatrial||
6026|068|P|shunts, mitral valve stenosis, chest pain, recent heart attack),||
6026|069|P|diabetes, high cholesterol, smoking/tobacco use, blood vessel||
6026|070|P|disease (such as Raynaud's disease), complications during||
6026|071|P|pregnancy (such as preeclampsia, eclampsia).||
6026|072|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6026|073|P|can make you more dizzy. Do not drive, use machinery, or do||
6026|074|P|anything that needs alertness until you can do it safely. Limit||
6026|075|P|alcoholic beverages. Talk to your doctor if you are using||
6026|076|P|marijuana (cannabis).||
6026|077|P|   Before having surgery, tell your doctor or dentist about all||
6026|078|P|the products you use (including prescription drugs,||
6026|079|P|nonprescription drugs, and herbal products).||
6026|080|P|   This medication must not be used during pregnancy. It may harm||
6026|081|P|an unborn baby. Consult your doctor for more details.||
6026|082|P|   Methylergonovine passes into breast milk in small amounts and||
6026|083|P|may have undesirable effects on a nursing infant. Consult your||
6026|084|P|doctor before breastfeeding.||
6026|085|B|||
6026|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6026|087|I|medications work or increase your risk for serious side effects.||
6026|088|I|This document does not contain all possible drug interactions.||
6026|089|I|Keep a list of all the products you use (including||
6026|090|I|prescription/nonprescription drugs and herbal products) and share||
6026|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
6026|092|I|the dosage of any medicines without your doctor's approval.||
6026|093|I|   Some products that may interact with this drug include: other||
6026|094|I|ergot alkaloids (such as ergotamine, dihydroergotamine),||
6026|095|I|"triptan" migraine medications (such as eletriptan, rizatriptan,||
6026|096|I|sumatriptan).||
6026|097|I|   Other medications can affect the removal of methylergonovine||
6026|098|I|from your body, which may affect how methylergonovine works.||
6026|099|I|Examples include adagrasib, cobicistat, mifepristone, nefazodone,||
6026|100|I|azole antifungals (such as itraconazole, ketoconazole), macrolide||
6026|101|I|antibiotics (such as erythromycin, clarithromycin), HIV protease||
6026|102|I|inhibitors (such as lopinavir), ritonavir, among others.||
6026|103|B|||
6026|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6026|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6026|106|O|poison control center right away. US residents can call||
6026|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6026|108|O|Symptoms of overdose may include: severe headache, severe||
6026|109|O|dizziness, seizures, slow/shallow breathing, numbness/tingling of||
6026|110|O|arms/legs.||
6026|111|B|||
6026|112|N|NOTES:  Do not share this medication with others.||
6026|113|N|   Lab and/or medical tests (such as blood pressure) may be done||
6026|114|N|while you are taking this medication. Keep all medical and lab||
6026|115|N|appointments. Consult your doctor for more details.||
6026|116|B|||
6026|117|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6026|118|D|remember. If it is near the time of the next dose, skip the||
6026|119|D|missed dose. Take your next dose at the regular time. Do not||
6026|120|D|double the dose to catch up.||
6026|121|B|||
6026|122|R|STORAGE:  Store at room temperature away from light and moisture.||
6026|123|R|Do not store in the bathroom. Keep all medications away from||
6026|124|R|children and pets.||
6026|125|R|   Do not flush medications down the toilet or pour them into a||
6026|126|R|drain unless instructed to do so. Properly discard this product||
6026|127|R|when it is expired or no longer needed. Consult your pharmacist||
6026|128|R|or local waste disposal company.||
6026|129|B|||
6026|130|A|Information last revised October 2024.||
6026|131|A|Copyright(c) 2025 First Databank, Inc.||
6026|132|B|||
6030|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6030|002|Z|does NOT have all possible information about this product. This||
6030|003|Z|information does not assure that this product is safe, effective,||
6030|004|Z|or appropriate for you. This information is not individual||
6030|005|Z|medical advice and does not substitute for the advice of your||
6030|006|Z|health care professional. Always ask your health care||
6030|007|Z|professional for complete information about this product and your||
6030|008|Z|specific health needs.||
6030|009|B|||
6030|010|T|TIMOLOL/DORZOLAMIDE DROPS - OPHTHALMIC||
6030|011|F|(TIE-moh-lohl/door-ZOHL-uh-mide)||
6030|012|B|||
6030|013|C|COMMON BRAND NAME(S): Cosopt||
6030|014|B|||
6030|015|U|USES:  This product contains two drugs used to treat high||
6030|016|U|pressure inside the eye due to glaucoma (open angle-type) or||
6030|017|U|other eye diseases (such as ocular hypertension). Lowering high||
6030|018|U|pressure inside the eye helps to prevent blindness. This||
6030|019|U|medication works by decreasing the amount of fluid within the||
6030|020|U|eye. Timolol belongs to a class of drugs known as beta-blockers,||
6030|021|U|and dorzolamide belongs to a class of drugs known as carbonic||
6030|022|U|anhydrase inhibitors.||
6030|023|B|||
6030|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6030|025|H|from your pharmacist before you start using timolol/dorzolamide||
6030|026|H|and each time you get a refill. If you have any questions, ask||
6030|027|H|your doctor or pharmacist.||
6030|028|H|   Use this medication in the affected eye(s) as directed by your||
6030|029|H|doctor, usually 2 times a day.||
6030|030|H|   To apply eye drops, wash your hands first. To avoid||
6030|031|H|contamination, do not touch the dropper tip or let it touch your||
6030|032|H|eye or any other surface.||
6030|033|H|   Some products contain a preservative that may be absorbed by||
6030|034|H|contact lenses. If you are using a product with a preservative||
6030|035|H|and you wear contact lenses, remove the lenses before using the||
6030|036|H|eye drops. Wait at least 15 minutes before putting in your||
6030|037|H|contact lenses.||
6030|038|H|   Tilt your head back, look upward and pull down the lower||
6030|039|H|eyelid to make a pouch. Hold the dropper directly over your eye||
6030|040|H|and place one drop in your eye. Look downward and gently close||
6030|041|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
6030|042|H|your eye (near the nose) and apply gentle pressure. Try not to||
6030|043|H|blink and do not rub your eye. This will prevent the medication||
6030|044|H|from draining out. Repeat these steps for your other eye if so||
6030|045|H|directed.||
6030|046|H|   Do not rinse the dropper. Replace the dropper cap after each||
6030|047|H|use.||
6030|048|H|   If you are using another kind of eye medication (such as drops||
6030|049|H|or ointments), wait at least 5 minutes before applying other||
6030|050|H|medications. Use eye drops before eye ointments to allow the eye||
6030|051|H|drops to enter the eye.||
6030|052|H|   Wait several minutes for your vision to clear before driving||
6030|053|H|or operating machinery.||
6030|054|H|   Use this medication regularly in order to get the most benefit||
6030|055|H|from it. To help you remember, use it at the same times each day.||
6030|056|H|Keep using this medication even if you feel well. Most people||
6030|057|H|with glaucoma or high pressure in the eyes do not feel sick.||
6030|058|B|||
6030|059|S|SIDE EFFECTS:  Temporary blurred vision, temporary||
6030|060|S|burning/stinging/itching/redness of the eye, watery eyes, dry||
6030|061|S|eyes, feeling as if something is in the eye, sensitivity of eyes||
6030|062|S|to light, strange taste in the mouth, or headache may occur. If||
6030|063|S|any of these effects last or get worse, tell your doctor or||
6030|064|S|pharmacist promptly.||
6030|065|S|   Remember that this medication has been prescribed because your||
6030|066|S|doctor has judged that the benefit to you is greater than the||
6030|067|S|risk of side effects. Many people using this medication do not||
6030|068|S|have serious side effects.||
6030|069|S|   Tell your doctor right away if you have any serious side||
6030|070|S|effects, including: dizziness, slow/irregular heartbeat, muscle||
6030|071|S|weakness, mental/mood changes, coldness/numbness/pain in the||
6030|072|S|hands or feet, vision changes, signs of a kidney stone (such as||
6030|073|S|pain in the back/side/abdomen, nausea/vomiting, blood in the||
6030|074|S|urine), yellowing eyes/skin, dark urine, unusual||
6030|075|S|tiredness/weakness, easy bruising/bleeding, signs of infection||
6030|076|S|(such as sore throat that doesn't go away, fever, chills).||
6030|077|S|   Get medical help right away if you have any very serious side||
6030|078|S|effects, including: eye redness or discharge that doesn't stop,||
6030|079|S|eye or eyelid swelling, eye pain, sudden unexplained weight gain,||
6030|080|S|chest pain, weakness on one side of the body, trouble speaking,||
6030|081|S|confusion, severe dizziness, fainting.||
6030|082|S|   A very serious allergic reaction to this drug is rare.||
6030|083|S|However, get medical help right away if you notice any symptoms||
6030|084|S|of a serious allergic reaction, including: rash, itching/swelling||
6030|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6030|086|S|breathing.||
6030|087|S|   This is not a complete list of possible side effects. If you||
6030|088|S|notice other effects not listed above, contact your doctor or||
6030|089|S|pharmacist.||
6030|090|S|   In the US -||
6030|091|S|   Call your doctor for medical advice about side effects. You||
6030|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6030|093|S|www.fda.gov/medwatch.||
6030|094|S|   In Canada - Call your doctor for medical advice about side||
6030|095|S|effects. You may report side effects to Health Canada at||
6030|096|S|1-866-234-2345.||
6030|097|B|||
6030|098|P|PRECAUTIONS:  Before using timolol/dorzolamide, tell your doctor||
6030|099|P|or pharmacist if you are allergic to these drugs; or if you have||
6030|100|P|any other allergies. This product may contain inactive||
6030|101|P|ingredients (such as preservatives like benzalkonium chloride),||
6030|102|P|which can cause allergic reactions or other problems. Talk to||
6030|103|P|your pharmacist for more details.||
6030|104|P|   Before using this medication, tell your doctor or pharmacist||
6030|105|P|your medical history, especially of: lung disease (such as||
6030|106|P|asthma, chronic obstructive pulmonary disease), certain types of||
6030|107|P|irregular heartbeats (such as sinus bradycardia, second or third||
6030|108|P|degree AV block), certain types of heart disease (such as heart||
6030|109|P|failure), kidney disease (such as kidney stones), liver disease,||
6030|110|P|diabetes, overactive thyroid disease, muscle weakness disorders,||
6030|111|P|low blood flow to the brain (cerebrovascular insufficiency),||
6030|112|P|severe allergies.||
6030|113|P|   If you develop an eye infection or injury, or have eye||
6030|114|P|surgery, check with your doctor about whether you should continue||
6030|115|P|to use your current bottle of timolol/dorzolamide. You may be||
6030|116|P|advised to start using a new bottle.||
6030|117|P|   Before having surgery, tell your doctor or dentist about all||
6030|118|P|the products you use (including prescription drugs,||
6030|119|P|nonprescription drugs, and herbal products).||
6030|120|P|   This product may prevent the fast/pounding heartbeat you would||
6030|121|P|usually feel when your blood sugar level falls too low||
6030|122|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
6030|123|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
6030|124|P|blood sugar level, such as dizziness and sweating, are not||
6030|125|P|affected by this drug.||
6030|126|P|   If you have diabetes, this product may make it harder to||
6030|127|P|control your blood sugar levels. Check your blood sugar levels||
6030|128|P|regularly as directed by your doctor. Tell your doctor right away||
6030|129|P|if you have symptoms of high blood sugar such as increased||
6030|130|P|thirst/urination. Your doctor may need to adjust your diabetes||
6030|131|P|medication, exercise program, or diet.||
6030|132|P|   After you apply this drug, your vision may become temporarily||
6030|133|P|blurred. Do not drive, use machinery, or do anything that needs||
6030|134|P|clear vision until you can do it safely.||
6030|135|P|   During pregnancy, this medication should be used only when||
6030|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
6030|137|P|   Timolol passes into breast milk. It is unknown if dorzolamide||
6030|138|P|passes into breast milk. Consult your doctor before||
6030|139|P|breastfeeding.||
6030|140|B|||
6030|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6030|142|I|medications work or increase your risk for serious side effects.||
6030|143|I|This document does not contain all possible drug interactions.||
6030|144|I|Keep a list of all the products you use (including||
6030|145|I|prescription/nonprescription drugs and herbal products) and share||
6030|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
6030|147|I|the dosage of any medicines without your doctor's approval.||
6030|148|I|   Some products that may interact with this drug include: oral||
6030|149|I|beta-blockers (such as propranolol), oral carbonic anhydrase||
6030|150|I|inhibitors (such as acetazolamide, methazolamide), clonidine,||
6030|151|I|certain antidepressants (including SSRIs such as fluoxetine),||
6030|152|I|digoxin, epinephrine, methyldopa, quinidine.||
6030|153|B|||
6030|154|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6030|155|O|has overdosed and has serious symptoms such as passing out or||
6030|156|O|trouble breathing, call 911. Otherwise, call a poison control||
6030|157|O|center right away. US residents can call 1-800-222-1222. Canada||
6030|158|O|residents can call 1-844-764-7669. Symptoms of overdose may||
6030|159|O|include: trouble breathing or slow/irregular heartbeat.||
6030|160|B|||
6030|161|N|NOTES:  Do not share this medication with others.||
6030|162|N|   Lab and/or medical tests (such as eye exams) should be done||
6030|163|N|while you are using this medication. Keep all medical and lab||
6030|164|N|appointments. Consult your doctor for more details.||
6030|165|B|||
6030|166|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6030|167|D|If it is near the time of the next dose, skip the missed dose.||
6030|168|D|Use your next dose at the regular time. Do not double the dose to||
6030|169|D|catch up.||
6030|170|B|||
6030|171|R|STORAGE:  Store at room temperature away from light. Keep the||
6030|172|R|single-use vials in the foil pouch until ready to use. Once the||
6030|173|R|foil pouch is opened, this medication expires after 15 days. Keep||
6030|174|R|all medications away from children and pets.||
6030|175|R|   Do not flush medications down the toilet or pour them into a||
6030|176|R|drain unless instructed to do so. Properly discard this product||
6030|177|R|when it is expired or no longer needed. Consult your pharmacist||
6030|178|R|or local waste disposal company.||
6030|179|B|||
6030|180|A|Information last revised May 2025.||
6030|181|A|Copyright(c) 2025 First Databank, Inc.||
6030|182|B|||
6037|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6037|002|Z|does NOT have all possible information about this product. This||
6037|003|Z|information does not assure that this product is safe, effective,||
6037|004|Z|or appropriate for you. This information is not individual||
6037|005|Z|medical advice and does not substitute for the advice of your||
6037|006|Z|health care professional. Always ask your health care||
6037|007|Z|professional for complete information about this product and your||
6037|008|Z|specific health needs.||
6037|009|B|||
6037|010|T|INSULIN ASPART - INJECTION||
6037|011|F|(IN-su-lin AS-part)||
6037|012|B|||
6037|013|C|COMMON BRAND NAME(S): Kirsty, Merilog, NovoLog||
6037|014|B|||
6037|015|U|USES:  Insulin aspart is used with a proper diet and exercise||
6037|016|U|program to control high blood sugar in people with diabetes.||
6037|017|U|Controlling high blood sugar helps prevent kidney damage,||
6037|018|U|blindness, nerve problems, loss of limbs, and sexual function||
6037|019|U|problems. Proper control of diabetes may also lessen your risk of||
6037|020|U|a heart attack or stroke.||
6037|021|U|   Insulin aspart is a man-made product that is similar to human||
6037|022|U|insulin. It replaces the insulin that your body would normally||
6037|023|U|make. Insulin aspart starts working faster and lasts for a||
6037|024|U|shorter time than regular insulin. It works by helping blood||
6037|025|U|sugar (glucose) get into cells so your body can use it for||
6037|026|U|energy. This medication is usually used with a medium- or||
6037|027|U|long-acting insulin product.||
6037|028|U|   This monograph is about the following insulin aspart products:||
6037|029|U|insulin aspart, insulin aspart-szjj, and insulin aspart-xjhz.||
6037|030|B|||
6037|031|H|HOW TO USE:  Read the Patient Information Leaflet and||
6037|032|H|Instructions for Use if available from your pharmacist before you||
6037|033|H|start using this medication and each time you get a refill. Ask||
6037|034|H|your health care professional how to prepare and use this||
6037|035|H|medication. If you have any questions, ask your doctor or||
6037|036|H|pharmacist.||
6037|037|H|   Inject this medication under the skin as directed by your||
6037|038|H|doctor, usually 5 to 10 minutes before meals. Because this||
6037|039|H|insulin is fast-acting, do not use insulin aspart if you are||
6037|040|H|unable to eat right after the injection or if you have low blood||
6037|041|H|sugar. Not eating right after a dose of this insulin may lead to||
6037|042|H|low blood sugar (hypoglycemia). The injection is given in the||
6037|043|H|stomach area, the thigh, the buttocks, or the back of the upper||
6037|044|H|arm. Do not inject into a vein or muscle because very low blood||
6037|045|H|sugar may occur.||
6037|046|H|   The dosage is based on your medical condition and response to||
6037|047|H|treatment. Measure each dose very carefully because even small||
6037|048|H|changes in the amount of insulin may have a large effect on your||
6037|049|H|blood sugar.||
6037|050|H|   Before using, check this product for particles or||
6037|051|H|discoloration. If either is present, do not use the insulin.||
6037|052|H|Before injecting each dose, clean the skin you are going to||
6037|053|H|inject into (the injection site) with rubbing alcohol. Change the||
6037|054|H|injection site each time to lessen injury under the skin (for||
6037|055|H|example, pits/lumps or thickened skin). Do not inject into skin||
6037|056|H|that is red, swollen, itchy, or damaged. Do not inject cold||
6037|057|H|insulin because this can be painful. The insulin container you||
6037|058|H|are currently using can be kept at room temperature. Learn how to||
6037|059|H|store and discard medical supplies safely.||
6037|060|H|   Giving insulin aspart into a vein should only be done by a||
6037|061|H|health care professional. Very low blood sugar may result.||
6037|062|H|   If you are directed to inject this insulin with an infusion||
6037|063|H|pump, read the instruction manual and directions that come with||
6037|064|H|the infusion pump. If you have any questions, ask your health||
6037|065|H|care professional. Avoid exposing the pump or its tubing to||
6037|066|H|direct sunlight or other heat sources. Do not dilute insulin if||
6037|067|H|you are using an insulin pump.||
6037|068|H|   This medication may be mixed with certain other insulin||
6037|069|H|products such as NPH insulin. Always draw the insulin aspart into||
6037|070|H|the syringe first, then follow with the longer-acting insulin.||
6037|071|H|Never inject a mixture of different insulins into a vein. Consult||
6037|072|H|your health care professional about which products may be mixed,||
6037|073|H|the proper method for mixing insulin, and the proper way to||
6037|074|H|inject mixtures of insulin. Do not mix insulins if you are using||
6037|075|H|an insulin pump.||
6037|076|H|   Do not change brands or types of insulin without directions on||
6037|077|H|how to do so from your doctor.||
6037|078|H|   Do not share your pen device with another person, even if the||
6037|079|H|needle is changed. You may give other people a serious infection,||
6037|080|H|or get a serious infection from them.||
6037|081|H|   Use this medication regularly to get the most benefit from it.||
6037|082|H|To help you remember, use it at the same times each day.||
6037|083|H|   Tell your doctor if your condition does not get better or if||
6037|084|H|it gets worse (your blood sugar is too high or too low).||
6037|085|B|||
6037|086|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
6037|087|S|irritation) or weight gain may occur. If any of these effects||
6037|088|S|last or get worse, tell your doctor or pharmacist promptly.||
6037|089|S|   Remember that this medication has been prescribed because your||
6037|090|S|doctor has judged that the benefit to you is greater than the||
6037|091|S|risk of side effects. Many people using this medication do not||
6037|092|S|have serious side effects.||
6037|093|S|   Tell your doctor right away if you have any serious side||
6037|094|S|effects, including: signs of low potassium level in the blood||
6037|095|S|(such as muscle cramps, weakness, irregular heartbeat).||
6037|096|S|   This medication can cause low blood sugar (hypoglycemia). This||
6037|097|S|may occur if you do not get enough calories from food or if you||
6037|098|S|do unusually heavy exercise. Symptoms of low blood sugar include||
6037|099|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
6037|100|S|dizziness, or tingling hands/feet. It is a good habit to carry||
6037|101|S|glucose tablets or gel to treat low blood sugar. If you don't||
6037|102|S|have these reliable forms of glucose, rapidly raise your blood||
6037|103|S|sugar by eating a quick source of sugar such as table sugar,||
6037|104|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
6037|105|S|doctor right away about the reaction and the use of this product.||
6037|106|S|To help prevent low blood sugar, eat meals on a regular schedule,||
6037|107|S|and do not skip meals. Check with your doctor or pharmacist to||
6037|108|S|find out what you should do if you miss a meal.||
6037|109|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
6037|110|S|thirst/urination. If these symptoms occur, tell your doctor right||
6037|111|S|away. Your doctor may need to adjust your diabetes medication,||
6037|112|S|exercise program, or diet.||
6037|113|S|   A very serious allergic reaction to this drug is rare.||
6037|114|S|However, get medical help right away if you notice any symptoms||
6037|115|S|of a serious allergic reaction, including: rash, itching/swelling||
6037|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6037|117|S|breathing.||
6037|118|S|   This is not a complete list of possible side effects. If you||
6037|119|S|notice other effects not listed above, contact your doctor or||
6037|120|S|pharmacist.||
6037|121|S|   In the US -||
6037|122|S|   Call your doctor for medical advice about side effects. You||
6037|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6037|124|S|www.fda.gov/medwatch.||
6037|125|S|   In Canada - Call your doctor for medical advice about side||
6037|126|S|effects. You may report side effects to Health Canada at||
6037|127|S|1-866-234-2345.||
6037|128|B|||
6037|129|P|PRECAUTIONS:  Before using insulin aspart, tell your doctor or||
6037|130|P|pharmacist if you are allergic to it; or to other insulins; or if||
6037|131|P|you have any other allergies. This product may contain inactive||
6037|132|P|ingredients, which can cause allergic reactions or other||
6037|133|P|problems. Talk to your pharmacist for more details.||
6037|134|P|   Do not use this medication when you have low blood sugar||
6037|135|P|(hypoglycemia).||
6037|136|P|   Before using this medication, tell your doctor or pharmacist||
6037|137|P|your medical history, especially of: kidney disease, liver||
6037|138|P|disease, thyroid problems.||
6037|139|P|   You may experience blurred vision, dizziness, or drowsiness||
6037|140|P|due to extremely low or high blood sugar. Do not drive, use||
6037|141|P|machinery, or do anything that needs alertness or clear vision||
6037|142|P|until you can do it safely.||
6037|143|P|   Limit alcohol while taking this medication because it can||
6037|144|P|increase your risk of developing low blood sugar.||
6037|145|P|   It may be harder to control your blood sugar when your body is||
6037|146|P|stressed (such as due to fever, infection, injury, or surgery).||
6037|147|P|Consult your doctor because this may require a change in your||
6037|148|P|treatment plan, medications, or blood sugar testing.||
6037|149|P|   Before having surgery, tell your doctor or dentist about all||
6037|150|P|the products you use (including prescription drugs,||
6037|151|P|nonprescription drugs, and herbal products).||
6037|152|P|   Check your blood sugar before and after exercise. You may need||
6037|153|P|a snack beforehand.||
6037|154|P|   If traveling across time zones, ask your doctor about how to||
6037|155|P|adjust your insulin schedule. Take extra insulin and supplies||
6037|156|P|with you.||
6037|157|P|   Older adults may be more sensitive to the side effects of this||
6037|158|P|drug, especially low blood sugar.||
6037|159|P|   Children may be more sensitive to the side effects of this||
6037|160|P|drug, especially low blood sugar.||
6037|161|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
6037|162|P|cause or worsen diabetes. Discuss a plan with your doctor for||
6037|163|P|managing your blood sugar while pregnant. Your doctor may change||
6037|164|P|your diabetes treatment during your pregnancy (such as diet and||
6037|165|P|medications including insulin).||
6037|166|P|   This medication passes into breast milk, but is unlikely to||
6037|167|P|harm a nursing infant. Consult your doctor before breastfeeding.||
6037|168|P|Your insulin needs may change while breastfeeding.||
6037|169|B|||
6037|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6037|171|I|medications work or increase your risk for serious side effects.||
6037|172|I|This document does not contain all possible drug interactions.||
6037|173|I|Keep a list of all the products you use (including||
6037|174|I|prescription/nonprescription drugs and herbal products) and share||
6037|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
6037|176|I|the dosage of any medicines without your doctor's approval.||
6037|177|I|   Beta-blocker medications (such as metoprolol, propranolol,||
6037|178|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
6037|179|I|heartbeat you would usually feel when your blood sugar falls too||
6037|180|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
6037|181|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
6037|182|I|   Many drugs can affect your blood sugar levels, making it more||
6037|183|I|difficult to control your blood sugar. Before you start, stop, or||
6037|184|I|change any medication, talk with your doctor or pharmacist about||
6037|185|I|how the medication may affect your blood sugar. Check your blood||
6037|186|I|sugar regularly as directed by your doctor. Tell your doctor||
6037|187|I|about the results and of any symptoms of high or low blood sugar.||
6037|188|I|(See also Side Effects section.) Your doctor may need to adjust||
6037|189|I|your diabetes medication, exercise program, or diet.||
6037|190|B|||
6037|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6037|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6037|193|O|poison control center right away. US residents can call||
6037|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6037|195|O|Symptoms of overdose may include: signs of low blood sugar such||
6037|196|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
6037|197|B|||
6037|198|N|NOTES:  Do not share this medication, needles, or syringes with||
6037|199|N|others.||
6037|200|N|   Attend a diabetes education program to learn more about how to||
6037|201|N|manage your diabetes with medications, diet, exercise, and||
6037|202|N|regular medical exams.||
6037|203|N|   Learn the symptoms of high and low blood sugar and how to||
6037|204|N|treat low blood sugar. Check your blood sugar regularly as||
6037|205|N|directed and share the results with your doctor.||
6037|206|N|   Lab and/or medical tests (such as liver/kidney function,||
6037|207|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
6037|208|N|should be done while you are taking this medication. Keep all||
6037|209|N|medical and lab appointments.||
6037|210|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
6037|211|B|||
6037|212|D|MISSED DOSE:  It is very important to follow your insulin regimen||
6037|213|D|exactly. Ask your doctor ahead of time what you should do if you||
6037|214|D|miss a dose of insulin.||
6037|215|B|||
6037|216|R|STORAGE:  Different brands of this medication have different||
6037|217|R|storage needs. Check the product package for instructions on how||
6037|218|R|to store your brand, or ask your pharmacist. Protect insulin from||
6037|219|R|light and heat. Do not store in the bathroom. Do not freeze, and||
6037|220|R|do not use insulin that has been frozen. Throw away all insulin||
6037|221|R|aspart in use after 28 days, even if there is insulin left. Also||
6037|222|R|throw away all insulin products after the expiration date on the||
6037|223|R|package. Keep all medications away from children and pets.||
6037|224|R|   If using this drug in an insulin pump, do not store this drug||
6037|225|R|in the pump for more than 6 days. Doing so may lead to||
6037|226|R|ineffective treatment and high blood sugar. Do not expose the||
6037|227|R|insulin in your pump to direct sunlight or temperatures above||
6037|228|R|98.6 degrees F (37 degrees C).||
6037|229|R|   Do not flush medications down the toilet or pour them into a||
6037|230|R|drain unless instructed to do so. Properly discard this product||
6037|231|R|when it is expired or no longer needed. Consult your pharmacist||
6037|232|R|or local waste disposal company.||
6037|233|B|||
6037|234|M|MEDICAL ALERT:  Your condition can cause complications in a||
6037|235|M|medical emergency. For information about enrolling in MedicAlert,||
6037|236|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6037|237|B|||
6037|238|A|Information last revised August 2025.||
6037|239|A|Copyright(c) 2025 First Databank, Inc.||
6037|240|B|||
6038|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6038|002|Z|does NOT have all possible information about this product. This||
6038|003|Z|information does not assure that this product is safe, effective,||
6038|004|Z|or appropriate for you. This information is not individual||
6038|005|Z|medical advice and does not substitute for the advice of your||
6038|006|Z|health care professional. Always ask your health care||
6038|007|Z|professional for complete information about this product and your||
6038|008|Z|specific health needs.||
6038|009|B|||
6038|010|T|MULTIVITAMINS/FLUORIDE CHEWABLE TABLET - ORAL||
6038|011|F|(multivitamins/FLOOR-ide)||
6038|012|B|||
6038|013|U|USES:  This medication is a combination product of vitamins and||
6038|014|U|fluoride. It is used by children to treat or prevent deficiency||
6038|015|U|due to poor diet or low levels of fluoride in drinking water and||
6038|016|U|other sources. Vitamins are important building blocks of the body||
6038|017|U|and help keep you in good health. Fluoride is used to prevent||
6038|018|U|dental cavities.||
6038|019|B|||
6038|020|H|HOW TO USE:  Chew this medication thoroughly and swallow, usually||
6038|021|H|once daily at bedtime after brushing the teeth or as directed by||
6038|022|H|the doctor. If your child cannot safely chew and swallow this||
6038|023|H|tablet, consult your doctor or pharmacist for advice.||
6038|024|H|   Take this medication at least 2 hours before or after taking||
6038|025|H|any products containing calcium (including milk, yogurt, other||
6038|026|H|dairy products) or aluminum/magnesium hydroxide (such as certain||
6038|027|H|antacids/laxatives) since these may decrease its effectiveness.||
6038|028|H|   The fluoride in this chewable tablet can be absorbed directly||
6038|029|H|into the teeth during and after chewing, as well as being||
6038|030|H|absorbed into your body from your stomach. It is best not to eat,||
6038|031|H|drink, or rinse your mouth for 30 minutes after taking this.||
6038|032|H|   Take this medication regularly in order to get the most||
6038|033|H|benefit from it. To help you remember, take it at the same time||
6038|034|H|each day. Do not take more than the prescribed dose.||
6038|035|B|||
6038|036|S|SIDE EFFECTS:  Stomach upset, constipation, or nausea may occur.||
6038|037|S|If any of these effects last or get worse, tell the doctor or||
6038|038|S|pharmacist promptly.||
6038|039|S|   If your teeth become mottled or stained, notify the dentist or||
6038|040|S|doctor. This may be a result of too much fluoride.||
6038|041|S|   Remember that this medication has been prescribed because your||
6038|042|S|doctor has judged that the benefit to you is greater than the||
6038|043|S|risk of side effects. Many people using this medication do not||
6038|044|S|have serious side effects.||
6038|045|S|   A very serious allergic reaction to this drug is rare.||
6038|046|S|However, get medical help right away if you notice any symptoms||
6038|047|S|of a serious allergic reaction, including: rash, itching/swelling||
6038|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6038|049|S|breathing.||
6038|050|S|   This is not a complete list of possible side effects. If you||
6038|051|S|notice other effects not listed above, contact your doctor or||
6038|052|S|pharmacist.||
6038|053|S|   In the US -||
6038|054|S|   Call your doctor for medical advice about side effects. You||
6038|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6038|056|S|www.fda.gov/medwatch.||
6038|057|S|   In Canada - Call your doctor for medical advice about side||
6038|058|S|effects. You may report side effects to Health Canada at||
6038|059|S|1-866-234-2345.||
6038|060|B|||
6038|061|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
6038|062|P|pharmacist if you are allergic to any of its ingredients; or if||
6038|063|P|you have any other allergies. This product may contain inactive||
6038|064|P|ingredients, which can cause allergic reactions or other||
6038|065|P|problems. Talk to your pharmacist for more details.||
6038|066|P|   Before taking this medication, tell your doctor or pharmacist||
6038|067|P|your medical history.||
6038|068|P|   Before having surgery, tell your doctor or dentist about all||
6038|069|P|the products you use (including prescription drugs,||
6038|070|P|nonprescription drugs, and herbal products).||
6038|071|P|   Tell your doctor if you are pregnant before taking this||
6038|072|P|medication.||
6038|073|P|   This product passes into breast milk. Consult your doctor||
6038|074|P|before breastfeeding.||
6038|075|B|||
6038|076|I|DRUG INTERACTIONS:  See also How to Use section.||
6038|077|I|   Drug interactions may change how your medications work or||
6038|078|I|increase your risk for serious side effects. This document does||
6038|079|I|not contain all possible drug interactions. Keep a list of all||
6038|080|I|the products you use (including prescription/nonprescription||
6038|081|I|drugs and herbal products) and share it with your doctor and||
6038|082|I|pharmacist. Do not start, stop, or change the dosage of any||
6038|083|I|medicines without your doctor's approval.||
6038|084|B|||
6038|085|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6038|086|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6038|087|O|poison control center right away. US residents can call||
6038|088|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6038|089|O|Symptoms of overdose may include: nausea, vomiting, stomach pain.||
6038|090|B|||
6038|091|N|NOTES:  Do not share this medication with others.||
6038|092|N|   This product is not a substitute for a proper diet. Remember||
6038|093|N|that it is best to get your vitamins from healthy foods. It is||
6038|094|N|important to maintain a well-balanced diet.||
6038|095|N|   Check the fluoride content of your water supply by asking||
6038|096|N|local town or city officials. Fluoride supplements are not||
6038|097|N|necessary if the fluoride content in the water supply is greater||
6038|098|N|than 0.6 parts per million. If your water supply changes, check||
6038|099|N|with your doctor or dentist to determine if extra fluoride is||
6038|100|N|still necessary.||
6038|101|B|||
6038|102|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6038|103|D|remember. If it is near the time of the next dose, skip the||
6038|104|D|missed dose. Take your next dose at the regular time. Do not||
6038|105|D|double the dose to catch up.||
6038|106|B|||
6038|107|R|STORAGE:  Store at room temperature away from heat and moisture.||
6038|108|R|Do not store in the bathroom. Keep all medications away from||
6038|109|R|children and pets.||
6038|110|R|   Do not flush medications down the toilet or pour them into a||
6038|111|R|drain unless instructed to do so. Properly discard this product||
6038|112|R|when it is expired or no longer needed. Consult your pharmacist||
6038|113|R|or local waste disposal company.||
6038|114|B|||
6038|115|A|Information last revised October 2025.||
6038|116|A|Copyright(c) 2025 First Databank, Inc.||
6038|117|B|||
6039|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6039|002|Z|does NOT have all possible information about this product. This||
6039|003|Z|information does not assure that this product is safe, effective,||
6039|004|Z|or appropriate for you. This information is not individual||
6039|005|Z|medical advice and does not substitute for the advice of your||
6039|006|Z|health care professional. Always ask your health care||
6039|007|Z|professional for complete information about this product and your||
6039|008|Z|specific health needs.||
6039|009|B|||
6039|010|T|ADAPALENE - TOPICAL||
6039|011|F|(a-DAP-a-leen)||
6039|012|B|||
6039|013|C|COMMON BRAND NAME(S): Differin||
6039|014|B|||
6039|015|U|USES:  This medication is used to treat acne. It may decrease the||
6039|016|U|number and severity of acne pimples and promote quick healing of||
6039|017|U|pimples that do develop. Adapalene belongs to a class of||
6039|018|U|medications called retinoids. It works by affecting the growth of||
6039|019|U|cells and decreasing swelling and inflammation.||
6039|020|B|||
6039|021|H|HOW TO USE:  If you are using the over-the-counter product to||
6039|022|H|self-treat, read and follow all directions on the product package||
6039|023|H|before using this medication. If you have any questions, consult||
6039|024|H|your pharmacist. If your doctor has prescribed this medication,||
6039|025|H|use it as directed.||
6039|026|H|   Use this medication as directed by your doctor or the product||
6039|027|H|package, usually once daily at bedtime. Before using, gently||
6039|028|H|clean the affected skin with a mild or soapless cleanser and pat||
6039|029|H|dry.||
6039|030|H|   If you are using the gel, cream, or lotion, wash your hands||
6039|031|H|before and after applying this medication. Use your fingertips to||
6039|032|H|apply a small amount of medication in a thin layer. If you are||
6039|033|H|using the medicated swab, unwrap the swab and apply a thin layer||
6039|034|H|to the affected area(s).||
6039|035|H|   Use this medication on the skin only. Avoid getting this||
6039|036|H|medication in your eyes or on your lips. Do not apply to the||
6039|037|H|inner lip area or inside the nose/mouth. If this medication gets||
6039|038|H|into your eyes, flush with large amounts of water. Call your||
6039|039|H|doctor if eye irritation develops. Do not apply to cut, scraped,||
6039|040|H|or sunburned areas, or to skin affected by eczema (a skin||
6039|041|H|condition).||
6039|042|H|   During the first few weeks of using adapalene, your acne might||
6039|043|H|appear worse because the medication is working on pimples forming||
6039|044|H|inside the skin. It may take 8 to 12 weeks to notice results from||
6039|045|H|this medication.||
6039|046|H|   Use this medication regularly to get the most benefit from it.||
6039|047|H|To help you remember, use it at the same time each day. Do not||
6039|048|H|use a larger amount or use it more often than directed. Your skin||
6039|049|H|will not improve any faster, and your risk of developing side||
6039|050|H|effects (such as redness, peeling, or pain) will increase.||
6039|051|H|   This medication is available in different strengths and forms||
6039|052|H|(such as gel, cream, lotion). The best type of medication for you||
6039|053|H|to use will depend on the condition of your skin and your||
6039|054|H|response to treatment. Tell your doctor if your condition does||
6039|055|H|not get better or if it gets worse.||
6039|056|H|   Since this drug is absorbed through the skin and may harm an||
6039|057|H|unborn baby, women who are pregnant or who may become pregnant||
6039|058|H|should not handle this medication.||
6039|059|B|||
6039|060|S|SIDE EFFECTS:  A brief sensation of warmth or stinging may occur||
6039|061|S|right after applying the medication. Skin redness, dryness,||
6039|062|S|itching, scaling, mild burning, or worsening of acne may occur||
6039|063|S|during the first 2-4 weeks of using the medication. These effects||
6039|064|S|usually decrease with continued use. If any of these effects||
6039|065|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
6039|066|S|Your doctor may want you to decrease how often you use adapalene,||
6039|067|S|change the strength, or have you stop using it.||
6039|068|S|   If your doctor has directed you to use this medication,||
6039|069|S|remember that your doctor has judged that the benefit to you is||
6039|070|S|greater than the risk of side effects. Many people using this||
6039|071|S|medication do not have serious side effects.||
6039|072|S|   Tell your doctor right away if you have any serious side||
6039|073|S|effects, including: very red/irritated skin, an intense burning||
6039|074|S|sensation, eye redness and watering (conjunctivitis), eyelid||
6039|075|S|swelling, skin discoloration.||
6039|076|S|   A very serious allergic reaction to this drug is rare.||
6039|077|S|However, get medical help right away if you notice any symptoms||
6039|078|S|of a serious allergic reaction, including: rash, itching/swelling||
6039|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6039|080|S|breathing.||
6039|081|S|   This is not a complete list of possible side effects. If you||
6039|082|S|notice other effects not listed above, contact your doctor or||
6039|083|S|pharmacist.||
6039|084|S|   In the US -||
6039|085|S|   Call your doctor for medical advice about side effects. You||
6039|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6039|087|S|www.fda.gov/medwatch.||
6039|088|S|   In Canada - Call your doctor for medical advice about side||
6039|089|S|effects. You may report side effects to Health Canada at||
6039|090|S|1-866-234-2345.||
6039|091|B|||
6039|092|P|PRECAUTIONS:  Before using adapalene, tell your doctor or||
6039|093|P|pharmacist if you are allergic to it; or to vitamin A-related||
6039|094|P|drugs (other retinoids such as isotretinoin); or if you have any||
6039|095|P|other allergies. This product may contain inactive ingredients,||
6039|096|P|which can cause allergic reactions or other problems. Talk to||
6039|097|P|your pharmacist for more details.||
6039|098|P|   Before using this medication, tell your doctor or pharmacist||
6039|099|P|your medical history, especially of: eczema.||
6039|100|P|   This medication may make you more sensitive to the sun. Limit||
6039|101|P|your time in the sun. Avoid tanning booths and sunlamps. Weather||
6039|102|P|extremes such as wind or cold may also be irritating to the skin.||
6039|103|P|Use sunscreen daily and wear protective clothing when outdoors.||
6039|104|P|Tell your doctor right away if you get sunburned or have skin||
6039|105|P|blisters/redness. Wait until your skin has completely recovered||
6039|106|P|from a sunburn before using adapalene.||
6039|107|P|   Avoid electrolysis, waxing and chemical depilatories for hair||
6039|108|P|removal on the treated areas while using this product.||
6039|109|P|   Since this drug is absorbed through the skin and may harm an||
6039|110|P|unborn baby, women who are pregnant or who may become pregnant||
6039|111|P|should not handle this medication.||
6039|112|P|   Tell your doctor if you are pregnant or plan to become||
6039|113|P|pregnant. You should not become pregnant while using adapalene.||
6039|114|P|Adapalene may harm an unborn baby. If you become pregnant, talk||
6039|115|P|to your doctor right away about the risks and benefits of this||
6039|116|P|medication.||
6039|117|P|   It is unknown if this drug passes into breast milk. Consult||
6039|118|P|your doctor before breastfeeding.||
6039|119|B|||
6039|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6039|121|I|medications work or increase your risk for serious side effects.||
6039|122|I|This document does not contain all possible drug interactions.||
6039|123|I|Keep a list of all the products you use (including||
6039|124|I|prescription/nonprescription drugs and herbal products) and share||
6039|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
6039|126|I|the dosage of any medicines without your doctor's approval.||
6039|127|I|   Avoid using other skin products that are harsh, irritating, or||
6039|128|I|drying on the treated area. These products include hair perming||
6039|129|I|solutions, alcohol/lime/menthol-containing products (such as||
6039|130|I|astringents, toners, shaving lotion), medicated or abrasive soaps||
6039|131|I|or cleansers, soaps and cosmetics with a strong drying effect||
6039|132|I|(such as alpha hydroxy acids, glycolic acid), and products||
6039|133|I|containing sulfur, resorcinol, salicylic acid.||
6039|134|I|   If you have recently used products containing sulfur,||
6039|135|I|resorcinol or salicylic acid, use adapalene with caution. Wait||
6039|136|I|until the effects of such products on the skin have decreased||
6039|137|I|before using adapalene.||
6039|138|B|||
6039|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6039|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6039|141|O|poison control center right away. US residents can call||
6039|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
6039|143|O|medication may be harmful if swallowed.||
6039|144|B|||
6039|145|N|NOTES:  Do not share this medication with others.||
6039|146|N|   Cosmetics may be used, but clean skin thoroughly before||
6039|147|N|applying the medication.||
6039|148|N|   Some cosmetics and soaps may worsen your acne. Moisturizers||
6039|149|N|may be safe to use. When buying cosmetics, moisturizers or other||
6039|150|N|skin care products, check the label for "non-comedogenic" or||
6039|151|N|"non-acnegenic." These products are unlikely to worsen your acne.||
6039|152|N|Ask your doctor or pharmacist which products are safe to use.||
6039|153|N|Remember, acne is not caused by dirt. Cleaning your skin too||
6039|154|N|often or too vigorously can irritate your skin and worsen acne.||
6039|155|B|||
6039|156|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6039|157|D|If you don't remember until the next morning, skip the missed||
6039|158|D|dose. Use your next dose at the regular time. Do not double the||
6039|159|D|dose to catch up.||
6039|160|B|||
6039|161|R|STORAGE:  Store at room temperature. Avoid freezing. Different||
6039|162|R|forms of this medication may have different storage requirements.||
6039|163|R|Read the package labeling or ask your pharmacist for the storage||
6039|164|R|requirements for the product you are using. Keep all medications||
6039|165|R|away from children and pets.||
6039|166|R|   Do not flush medications down the toilet or pour them into a||
6039|167|R|drain unless instructed to do so. Properly discard this product||
6039|168|R|when it is expired or no longer needed. Consult your pharmacist||
6039|169|R|or local waste disposal company.||
6039|170|B|||
6039|171|A|Information last revised July 2025.||
6039|172|A|Copyright(c) 2025 First Databank, Inc.||
6039|173|B|||
6041|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6041|002|Z|does NOT have all possible information about this product. This||
6041|003|Z|information does not assure that this product is safe, effective,||
6041|004|Z|or appropriate for you. This information is not individual||
6041|005|Z|medical advice and does not substitute for the advice of your||
6041|006|Z|health care professional. Always ask your health care||
6041|007|Z|professional for complete information about this product and your||
6041|008|Z|specific health needs.||
6041|009|B|||
6041|010|T|LEVODOPA/BENSERAZIDE - ORAL||
6041|011|F|(LEE-voe-DOE-pa/ben-SER-a-zide)||
6041|012|B|||
6041|013|U|USES:  This combination medication is used to treat symptoms of||
6041|014|U|Parkinson's disease (such as shakiness, stiffness, difficulty||
6041|015|U|moving). Parkinson's disease is thought to be caused by too||
6041|016|U|little of a naturally occurring substance (dopamine) in the||
6041|017|U|brain. Levodopa changes into dopamine in the brain, helping to||
6041|018|U|control movement. Benserazide prevents the breakdown of levodopa||
6041|019|U|in the bloodstream so more levodopa can enter the brain.||
6041|020|U|Benserazide can also reduce some of levodopa's side effects such||
6041|021|U|as nausea and vomiting.||
6041|022|U|   This medication must not be used by people who are younger||
6041|023|U|than 25 years.||
6041|024|B|||
6041|025|H|HOW TO USE:  Take this medication by mouth with food as directed||
6041|026|H|by your doctor, usually 4 to 6 times a day. Swallow the capsules||
6041|027|H|whole and do not open them or dissolve them in liquid.||
6041|028|H|   It is best to avoid a high-protein diet (it decreases the||
6041|029|H|amount of levodopa that your body takes in) during treatment,||
6041|030|H|unless directed otherwise by your doctor. Separate your dose of||
6041|031|H|this medication by as many hours as possible from any iron||
6041|032|H|supplements or products containing iron (such as multivitamins||
6041|033|H|with minerals) you may take. Iron can reduce the amount of this||
6041|034|H|medication absorbed by the body. Consult your doctor or||
6041|035|H|pharmacist for more details.||
6041|036|H|   The dosage is based on your medical condition and response to||
6041|037|H|treatment. To reduce your risk of side effects, your doctor may||
6041|038|H|direct you to start this medication at a low dose and gradually||
6041|039|H|increase your dose. Follow your doctor's instructions carefully.||
6041|040|H|   Some patients may experience a "wearing-off" (worsening of||
6041|041|H|symptoms) before the next dose is due. An "on-off" effect might||
6041|042|H|also occur, in which sudden short periods of stiffness occur. If||
6041|043|H|these effects occur, contact your doctor for possible dose||
6041|044|H|adjustments that may help to lessen this effect.||
6041|045|H|   Do not stop taking this medication without consulting your||
6041|046|H|doctor. Some conditions may become worse when this medication is||
6041|047|H|suddenly stopped. Also, if you suddenly stop using this||
6041|048|H|medication, you may have withdrawal symptoms (such as anxiety,||
6041|049|H|depression, confusion, fever, muscle stiffness). To help prevent||
6041|050|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
6041|051|H|more likely if you have used this medication for a long time or||
6041|052|H|in high doses. Tell your doctor or pharmacist right away if you||
6041|053|H|have withdrawal.||
6041|054|H|   Use this medication regularly to get the most benefit from it.||
6041|055|H|To help you remember, take it at the same times each day.||
6041|056|H|   Tell your doctor if your condition does not get better or if||
6041|057|H|it gets worse.||
6041|058|B|||
6041|059|S|SIDE EFFECTS:  Dizziness, lightheadedness, nausea, vomiting, loss||
6041|060|S|of appetite, trouble sleeping, unusual dreams, or headache may||
6041|061|S|occur. If any of these effects last or get worse, tell your||
6041|062|S|doctor or pharmacist promptly.||
6041|063|S|   This medication may cause saliva, urine, or sweat to turn a||
6041|064|S|dark color. This effect is harmless, but your clothes may be||
6041|065|S|stained.||
6041|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
6041|067|S|slowly when rising from a sitting or lying position.||
6041|068|S|   Remember that this medication has been prescribed because your||
6041|069|S|doctor has judged that the benefit to you is greater than the||
6041|070|S|risk of side effects. Many people using this medication do not||
6041|071|S|have serious side effects.||
6041|072|S|   Some people taking this medication have fallen asleep suddenly||
6041|073|S|during their usual daily activities (such as talking on the||
6041|074|S|phone, driving). In some cases, sleep occurred without any||
6041|075|S|feelings of drowsiness beforehand. This sleep effect may occur||
6041|076|S|anytime during treatment with this medication even if you have||
6041|077|S|used this medication for a long time. If you experience increased||
6041|078|S|sleepiness or fall asleep during the day, do not drive or do||
6041|079|S|other possibly dangerous activities until you have discussed this||
6041|080|S|effect with your doctor. Your risk of this sleep effect is||
6041|081|S|increased by using alcohol or other medications that can make you||
6041|082|S|drowsy. See also Precautions section.||
6041|083|S|   Tell your doctor right away if you have any serious side||
6041|084|S|effects, including: new/worsening movements you can't||
6041|085|S|control/spasms, greatly increased eye blinking/twitching, vision||
6041|086|S|changes (such as blurred vision, double vision), eye pain, severe||
6041|087|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
6041|088|S|coffee grounds, mental/mood changes (such as confusion,||
6041|089|S|agitation, hallucinations), signs of infection (such as sore||
6041|090|S|throat that doesn't go away, fever, chills), easy||
6041|091|S|bleeding/bruising, unusual tiredness, tingling of the hands/feet,||
6041|092|S|unusual strong urges (such as increased gambling, increased||
6041|093|S|sexual urges).||
6041|094|S|   Get medical help right away if you have any very serious side||
6041|095|S|effects, including: chest pain, fainting.||
6041|096|S|   Abruptly stopping or reducing the dose of this medication may||
6041|097|S|rarely cause a very serious condition called neuroleptic||
6041|098|S|malignant syndrome (NMS). Get medical help right away if you have||
6041|099|S|any of the following symptoms: fever, unusual muscle stiffness,||
6041|100|S|severe confusion, sweating, fast/irregular heartbeat.||
6041|101|S|   A very serious allergic reaction to this drug is rare.||
6041|102|S|However, get medical help right away if you notice any symptoms||
6041|103|S|of a serious allergic reaction, including: rash, itching/swelling||
6041|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6041|105|S|breathing.||
6041|106|S|   This is not a complete list of possible side effects. If you||
6041|107|S|notice other effects not listed above, contact your doctor or||
6041|108|S|pharmacist.||
6041|109|S|   In the US -||
6041|110|S|   Call your doctor for medical advice about side effects. You||
6041|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6041|112|S|www.fda.gov/medwatch.||
6041|113|S|   In Canada - Call your doctor for medical advice about side||
6041|114|S|effects. You may report side effects to Health Canada at||
6041|115|S|1-866-234-2345.||
6041|116|B|||
6041|117|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
6041|118|P|pharmacist if you are allergic to levodopa or benserazide; or to||
6041|119|P|foslevodopa; or if you have any other allergies. This product may||
6041|120|P|contain inactive ingredients, which can cause allergic reactions||
6041|121|P|or other problems. Talk to your pharmacist for more details.||
6041|122|P|   Before using this medication, tell your doctor or pharmacist||
6041|123|P|your medical history, especially of: liver disease, glaucoma,||
6041|124|P|breathing problems (such as asthma), heart disease (such as||
6041|125|P|irregular heartbeat, heart attack), kidney disease,||
6041|126|P|stomach/intestinal ulcer, mental/mood disorders (such as||
6041|127|P|depression, schizophrenia), blood disorders, seizures, sleep||
6041|128|P|disorders.||
6041|129|P|   Before having surgery, tell your doctor or dentist about all||
6041|130|P|the products you use (including prescription drugs,||
6041|131|P|nonprescription drugs, and herbal products).||
6041|132|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6041|133|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6041|134|P|machinery, or do anything that needs alertness until you can do||
6041|135|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
6041|136|P|are using marijuana (cannabis). See also Side Effects section.||
6041|137|P|   This medication must not be used during pregnancy. It may harm||
6041|138|P|an unborn baby. It is important to prevent pregnancy while taking||
6041|139|P|this medication. Consult your doctor for more details and to||
6041|140|P|discuss the use of reliable forms of birth control (such as||
6041|141|P|condoms, birth control pills) while taking this medication. If||
6041|142|P|you become pregnant or think you may be pregnant, tell your||
6041|143|P|doctor right away.||
6041|144|P|   Levodopa passes into breast milk. It is unknown if benserazide||
6041|145|P|passes into breast milk. Consult your doctor before||
6041|146|P|breastfeeding.||
6041|147|B|||
6041|148|I|DRUG INTERACTIONS:  See also How to Use section.||
6041|149|I|   Drug interactions may change how your medications work or||
6041|150|I|increase your risk for serious side effects. This document does||
6041|151|I|not contain all possible drug interactions. Keep a list of all||
6041|152|I|the products you use (including prescription/nonprescription||
6041|153|I|drugs and herbal products) and share it with your doctor and||
6041|154|I|pharmacist. Do not start, stop, or change the dosage of any||
6041|155|I|medicines without your doctor's approval.||
6041|156|I|   Taking MAO inhibitors with this medication may cause a serious||
6041|157|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
6041|158|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
6041|159|I|moclobemide, phenelzine, procarbazine, tranylcypromine) during||
6041|160|I|treatment with this medication. Most MAO inhibitors should also||
6041|161|I|not be taken for two weeks before treatment with this medication.||
6041|162|I|However, certain MAO inhibitors (rasagiline, safinamide,||
6041|163|I|selegiline) may be used with careful monitoring by your doctor.||
6041|164|I|Ask your doctor when to start or stop taking this medication.||
6041|165|I|   This medication may interfere with certain lab tests (such as||
6041|166|I|urine catecholamine/glucose/ketone tests), possibly causing false||
6041|167|I|test results. Make sure lab personnel and all your doctors know||
6041|168|I|you use this drug.||
6041|169|B|||
6041|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6041|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6041|172|O|poison control center right away. US residents can call||
6041|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6041|174|O|Symptoms of overdose may include: severe dizziness, irregular||
6041|175|O|heartbeat, mental/mood changes (such as confusion).||
6041|176|B|||
6041|177|N|NOTES:  Do not share this medication with others.||
6041|178|N|   Lab and/or medical tests (such as complete blood count,||
6041|179|N|heart/liver/kidney function, blood pressure) should be done while||
6041|180|N|you are taking this medication. Keep all medical and lab||
6041|181|N|appointments. Consult your doctor for more details.||
6041|182|B|||
6041|183|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6041|184|D|remember. If it is near the time of the next dose, skip the||
6041|185|D|missed dose. Take your next dose at the regular time. Do not||
6041|186|D|double the dose to catch up.||
6041|187|B|||
6041|188|R|STORAGE:  Store at room temperature away from light and moisture.||
6041|189|R|Do not store in the bathroom. Keep all medications away from||
6041|190|R|children and pets.||
6041|191|R|   Do not flush medications down the toilet or pour them into a||
6041|192|R|drain unless instructed to do so. Properly discard this product||
6041|193|R|when it is expired or no longer needed. Consult your pharmacist||
6041|194|R|or local waste disposal company.||
6041|195|B|||
6041|196|A|Information last revised May 2025.||
6041|197|A|Copyright(c) 2025 First Databank, Inc.||
6041|198|B|||
6043|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6043|002|Z|does NOT have all possible information about this product. This||
6043|003|Z|information does not assure that this product is safe, effective,||
6043|004|Z|or appropriate for you. This information is not individual||
6043|005|Z|medical advice and does not substitute for the advice of your||
6043|006|Z|health care professional. Always ask your health care||
6043|007|Z|professional for complete information about this product and your||
6043|008|Z|specific health needs.||
6043|009|B|||
6043|010|T|BUMETANIDE - INJECTION||
6043|011|F|(bue-MET-a-nide)||
6043|012|B|||
6043|013|C|COMMON BRAND NAME(S): Bumex||
6043|014|B|||
6043|015|W|WARNING:  Bumetanide is a very strong medication. Using too much||
6043|016|W|of this drug can lead to dehydration and electrolyte imbalance.||
6043|017|W|It is important that you are closely monitored by your doctor||
6043|018|W|while using this medication. Tell your doctor right away if you||
6043|019|W|have any symptoms of dehydration or electrolyte imbalance,||
6043|020|W|including unusual dry mouth/thirst, muscle cramps/weakness,||
6043|021|W|slow/fast/irregular heartbeat, or confusion.||
6043|022|B|||
6043|023|U|USES:  Bumetanide is used to reduce extra fluid in the body||
6043|024|U|(edema) caused by conditions such as heart failure, liver||
6043|025|U|disease, and kidney disease. Getting rid of extra water helps to||
6043|026|U|reduce fluid in the lungs so that you can breathe easier. It also||
6043|027|U|helps to decrease swelling of the arms, legs, and||
6043|028|U|stomach/abdomen. This medication is known as a diuretic (the same||
6043|029|U|kind of drug as a "water pill"). It causes your body to get rid||
6043|030|U|of extra water by increasing the amount of urine you make.||
6043|031|B|||
6043|032|H|HOW TO USE:  This medication is given by injection into a vein or||
6043|033|H|into a muscle, as directed by your doctor. The dosage is based on||
6043|034|H|your medical condition and response to treatment. Do not increase||
6043|035|H|your dose, use this more often than prescribed, or stop using||
6043|036|H|this medication without consulting your doctor.||
6043|037|H|   If you are giving this medication to yourself at home, learn||
6043|038|H|all preparation and usage instructions from your health care||
6043|039|H|professional. Before using, check this product for particles or||
6043|040|H|discoloration. If either is present, do not use the liquid. Learn||
6043|041|H|how to store and discard medical supplies safely.||
6043|042|H|   If you use this drug too close to bedtime, you may need to||
6043|043|H|wake up to urinate. It is best to use this medication at least 4||
6043|044|H|hours before your bedtime. Consult your doctor or pharmacist if||
6043|045|H|you have questions about your dosing schedule.||
6043|046|H|   Tell your doctor if your condition lasts or gets worse.||
6043|047|B|||
6043|048|S|SIDE EFFECTS:  See also Warning section.||
6043|049|S|   Dizziness, lightheadedness, headache, tiredness, nausea, or||
6043|050|S|pain/redness at the injection site may occur. If any of these||
6043|051|S|effects last or get worse, tell your doctor or pharmacist||
6043|052|S|promptly.||
6043|053|S|   To reduce the risk of dizziness and lightheadedness, get up||
6043|054|S|slowly when rising from a sitting or lying position.||
6043|055|S|   Remember that this medication has been prescribed because your||
6043|056|S|doctor has judged that the benefit to you is greater than the||
6043|057|S|risk of side effects. Many people using this medication do not||
6043|058|S|have serious side effects.||
6043|059|S|   Tell your doctor right away if you have any serious side||
6043|060|S|effects, including: numbness/tingling/pain/redness/swelling of||
6043|061|S|the arms/legs, fainting, hearing changes (such as ringing in the||
6043|062|S|ears, decreased hearing), easy bruising/bleeding, signs of kidney||
6043|063|S|problems (such as change in the amount of urine).||
6043|064|S|   A very serious allergic reaction to this drug is rare.||
6043|065|S|However, get medical help right away if you notice any symptoms||
6043|066|S|of a serious allergic reaction, including: rash, itching/swelling||
6043|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6043|068|S|breathing.||
6043|069|S|   This is not a complete list of possible side effects. If you||
6043|070|S|notice other effects not listed above, contact your doctor or||
6043|071|S|pharmacist.||
6043|072|S|   In the US -||
6043|073|S|   Call your doctor for medical advice about side effects. You||
6043|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6043|075|S|www.fda.gov/medwatch.||
6043|076|S|   In Canada - Call your doctor for medical advice about side||
6043|077|S|effects. You may report side effects to Health Canada at||
6043|078|S|1-866-234-2345.||
6043|079|B|||
6043|080|P|PRECAUTIONS:  Before using bumetanide, tell your doctor or||
6043|081|P|pharmacist if you are allergic to it; or if you have any other||
6043|082|P|allergies. This product may contain inactive ingredients, which||
6043|083|P|can cause allergic reactions or other problems. Talk to your||
6043|084|P|pharmacist for more details.||
6043|085|P|   Before using this medication, tell your doctor or pharmacist||
6043|086|P|your medical history, especially of: kidney problems (such as||
6043|087|P|inability to make urine), liver problems, gout.||
6043|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6043|089|P|can make you more dizzy. Do not drive, use machinery, or do||
6043|090|P|anything that needs alertness until you can do it safely. Limit||
6043|091|P|alcoholic beverages. Talk to your doctor if you are using||
6043|092|P|marijuana (cannabis).||
6043|093|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
6043|094|P|and cause you to feel lightheaded. Tell your doctor if you have||
6043|095|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
6043|096|P|of fluids unless your doctor tells you not to.||
6043|097|P|   If you have diabetes, bumetanide may rarely make it harder to||
6043|098|P|control your blood sugar. Monitor your blood sugar levels||
6043|099|P|regularly and share the results with your doctor.||
6043|100|P|   This drug may reduce the potassium levels in your blood. Ask||
6043|101|P|your doctor about adding potassium to your diet. Your doctor may||
6043|102|P|prescribe a potassium supplement.||
6043|103|P|   Before having surgery, tell your doctor or dentist about all||
6043|104|P|the products you use (including prescription drugs,||
6043|105|P|nonprescription drugs, and herbal products).||
6043|106|P|   Older adults may be more sensitive to the effects of this||
6043|107|P|drug, especially dizziness and water/mineral loss.||
6043|108|P|   During pregnancy, this drug should be used only when clearly||
6043|109|P|needed. Discuss the risks and benefits with your doctor.||
6043|110|P|   It is unknown if this drug passes into breast milk. Consult||
6043|111|P|your doctor before breastfeeding.||
6043|112|B|||
6043|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6043|114|I|medications work or increase your risk for serious side effects.||
6043|115|I|This document does not contain all possible drug interactions.||
6043|116|I|Keep a list of all the products you use (including||
6043|117|I|prescription/nonprescription drugs and herbal products) and share||
6043|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
6043|119|I|the dosage of any medicines without your doctor's approval.||
6043|120|I|   Some products that may interact with this drug are:||
6043|121|I|desmopressin, lithium, probenecid.||
6043|122|I|   Some products have ingredients that could raise your blood||
6043|123|I|pressure or worsen your swelling. Tell your pharmacist what||
6043|124|I|products you are using, and ask how to use them safely||
6043|125|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
6043|126|I|ibuprofen/naproxen).||
6043|127|B|||
6043|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6043|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6043|130|O|poison control center right away. US residents can call||
6043|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6043|132|O|Symptoms of overdose may include: fainting, severe weakness, a||
6043|133|O|severe decrease in the amount of urine.||
6043|134|B|||
6043|135|N|NOTES:  Do not share this medication with others.||
6043|136|N|   Lab and/or medical tests (such as kidney function, blood||
6043|137|N|mineral levels such as potassium) should be done while you are||
6043|138|N|using this medication. Keep all medical and lab appointments.||
6043|139|N|Consult your doctor for more details.||
6043|140|B|||
6043|141|D|MISSED DOSE:  It is important to get each dose of this medication||
6043|142|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6043|143|D|right away for a new dosing schedule. Do not double the dose to||
6043|144|D|catch up.||
6043|145|B|||
6043|146|R|STORAGE:  Consult the product instructions and your pharmacist||
6043|147|R|for storage details. Keep all medications away from children and||
6043|148|R|pets.||
6043|149|R|   Do not flush medications down the toilet or pour them into a||
6043|150|R|drain unless instructed to do so. Properly discard this product||
6043|151|R|when it is expired or no longer needed. Consult your pharmacist||
6043|152|R|or local waste disposal company.||
6043|153|B|||
6043|154|A|Information last revised October 2025.||
6043|155|A|Copyright(c) 2025 First Databank, Inc.||
6043|156|B|||
6046|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6046|002|Z|does NOT have all possible information about this product. This||
6046|003|Z|information does not assure that this product is safe, effective,||
6046|004|Z|or appropriate for you. This information is not individual||
6046|005|Z|medical advice and does not substitute for the advice of your||
6046|006|Z|health care professional. Always ask your health care||
6046|007|Z|professional for complete information about this product and your||
6046|008|Z|specific health needs.||
6046|009|B|||
6046|010|T|THIOGUANINE - ORAL||
6046|011|F|(THYE-oh-GWA-neen)||
6046|012|B|||
6046|013|C|COMMON BRAND NAME(S): Tabloid||
6046|014|B|||
6046|015|U|USES:  Thioguanine is used to treat a certain type of cancer||
6046|016|U|(acute myeloid leukemia-AML). It is a chemotherapy drug that||
6046|017|U|works by slowing or stopping the growth of cancer cells.||
6046|018|B|||
6046|019|V|OTHER USES:  This section contains uses of this drug that are not||
6046|020|V|listed in the approved professional labeling for the drug but||
6046|021|V|that may be prescribed by your health care professional. Use this||
6046|022|V|drug for a condition that is listed in this section only if it||
6046|023|V|has been so prescribed by your health care professional.||
6046|024|V|   This drug may also be used for other types of leukemia and||
6046|025|V|brain tumor.||
6046|026|B|||
6046|027|H|HOW TO USE:  Take this medication by mouth with or without food||
6046|028|H|as directed by your doctor, usually once daily. Drink plenty of||
6046|029|H|fluids while taking this medication unless otherwise directed by||
6046|030|H|your doctor. Doing so may help decrease the risk of certain side||
6046|031|H|effects (kidney problems).||
6046|032|H|   The dosage is based on your medical condition, weight, and||
6046|033|H|response to treatment. Do not increase your dose or use this drug||
6046|034|H|more often or for longer than prescribed. Your condition will not||
6046|035|H|improve any faster, and your risk of serious side effects will||
6046|036|H|increase.||
6046|037|H|   Use this medication regularly to get the most benefit from it.||
6046|038|H|To help you remember, take it at the same time each day.||
6046|039|H|   Since this drug can be absorbed through the skin and lungs and||
6046|040|H|may harm an unborn baby, women who are pregnant or who may become||
6046|041|H|pregnant should not handle this medication or breathe the dust||
6046|042|H|from the tablets.||
6046|043|B|||
6046|044|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, and mouth||
6046|045|S|sores may occur. If any of these effects last or get worse, tell||
6046|046|S|your doctor or pharmacist promptly.||
6046|047|S|   People using this medication may have serious side effects.||
6046|048|S|However, you have been prescribed this drug because your doctor||
6046|049|S|has judged that the benefit to you is greater than the risk of||
6046|050|S|side effects. Careful monitoring by your doctor may decrease your||
6046|051|S|risk.||
6046|052|S|   Tell your doctor right away if you have any serious side||
6046|053|S|effects, including: joint pain/swelling, black stools, vomit that||
6046|054|S|looks like coffee grounds, symptoms of liver disease (such as||
6046|055|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
6046|056|S|yellowing eyes/skin, dark urine).||
6046|057|S|   This medication may decrease bone marrow function, an effect||
6046|058|S|that may lead to a low number of blood cells such as red cells,||
6046|059|S|white cells, and platelets. This effect can cause anemia,||
6046|060|S|decrease your body's ability to fight an infection, or cause easy||
6046|061|S|bruising/bleeding. Tell your doctor right away if you develop any||
6046|062|S|of the following symptoms: unusual tiredness, pale skin, signs of||
6046|063|S|infection (such as sore throat that doesn't go away, fever,||
6046|064|S|chills), easy bruising/bleeding.||
6046|065|S|   A very serious allergic reaction to this drug is rare.||
6046|066|S|However, get medical help right away if you notice any symptoms||
6046|067|S|of a serious allergic reaction, including: rash, itching/swelling||
6046|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6046|069|S|breathing.||
6046|070|S|   This is not a complete list of possible side effects. If you||
6046|071|S|notice other effects not listed above, contact your doctor or||
6046|072|S|pharmacist.||
6046|073|S|   In the US -||
6046|074|S|   Call your doctor for medical advice about side effects. You||
6046|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6046|076|S|www.fda.gov/medwatch.||
6046|077|S|   In Canada - Call your doctor for medical advice about side||
6046|078|S|effects. You may report side effects to Health Canada at||
6046|079|S|1-866-234-2345.||
6046|080|B|||
6046|081|P|PRECAUTIONS:  Before taking thioguanine, tell your doctor or||
6046|082|P|pharmacist if you are allergic to it; or if you have any other||
6046|083|P|allergies. This product may contain inactive ingredients, which||
6046|084|P|can cause allergic reactions or other problems. Talk to your||
6046|085|P|pharmacist for more details.||
6046|086|P|   Before using this medication, tell your doctor or pharmacist||
6046|087|P|your medical history, especially of: kidney disease, liver||
6046|088|P|disease, certain enzyme disorders (TPMT or NUDT15 deficiency).||
6046|089|P|   Thioguanine can make you more likely to get infections or may||
6046|090|P|make current infections worse. Stay away from anyone who has an||
6046|091|P|infection that may easily spread (such as chickenpox, COVID-19,||
6046|092|P|measles, flu). Talk to your doctor if you have been exposed to an||
6046|093|P|infection or for more details.||
6046|094|P|   Tell your health care professional that you are using||
6046|095|P|thioguanine before having any immunizations/vaccinations. Avoid||
6046|096|P|contact with people who have recently received live vaccines||
6046|097|P|(such as flu vaccine inhaled through the nose).||
6046|098|P|   To lower the chance of getting cut, bruised, or injured, use||
6046|099|P|caution with sharp objects like razors and nail cutters, and||
6046|100|P|avoid activities such as contact sports.||
6046|101|P|   Before having surgery, tell your doctor or dentist about all||
6046|102|P|the products you use (including prescription drugs,||
6046|103|P|nonprescription drugs, and herbal products).||
6046|104|P|   Since this drug can be absorbed through the skin and lungs and||
6046|105|P|may harm an unborn baby, women who are pregnant or who may become||
6046|106|P|pregnant should not handle this medication or breathe the dust||
6046|107|P|from the tablets.||
6046|108|P|   Tell your doctor if you are pregnant or plan to become||
6046|109|P|pregnant. You should not become pregnant while using thioguanine.||
6046|110|P|Thioguanine may harm an unborn baby. Ask about reliable forms of||
6046|111|P|birth control while using this medication. If you become||
6046|112|P|pregnant, talk to your doctor right away about the risks and||
6046|113|P|benefits of this medication.||
6046|114|P|   It is unknown if this drug passes into breast milk. Because of||
6046|115|P|the possible risk to the infant, breastfeeding is not recommended||
6046|116|P|while using this drug. Consult your doctor before breastfeeding.||
6046|117|B|||
6046|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6046|119|I|medications work or increase your risk for serious side effects.||
6046|120|I|This document does not contain all possible drug interactions.||
6046|121|I|Keep a list of all the products you use (including||
6046|122|I|prescription/nonprescription drugs and herbal products) and share||
6046|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
6046|124|I|the dosage of any medicines without your doctor's approval.||
6046|125|B|||
6046|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6046|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6046|128|O|poison control center right away. US residents can call||
6046|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6046|130|B|||
6046|131|N|NOTES:  Do not share this medication with others.||
6046|132|N|   Lab and/or medical tests (such as complete blood count,||
6046|133|N|liver/kidney function) should be done while you are taking this||
6046|134|N|medication. Keep all medical and lab appointments. Consult your||
6046|135|N|doctor for more details.||
6046|136|B|||
6046|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6046|138|D|remember. If it is near the time of the next dose, skip the||
6046|139|D|missed dose. Take your next dose at the regular time. Do not||
6046|140|D|double the dose to catch up.||
6046|141|B|||
6046|142|R|STORAGE:  Store at room temperature away from light and moisture.||
6046|143|R|Do not store in the bathroom. Keep all medications away from||
6046|144|R|children and pets.||
6046|145|R|   Do not flush medications down the toilet or pour them into a||
6046|146|R|drain unless instructed to do so. Properly discard this product||
6046|147|R|when it is expired or no longer needed. Consult your pharmacist||
6046|148|R|or local waste disposal company.||
6046|149|B|||
6046|150|M|MEDICAL ALERT:  Your condition can cause complications in a||
6046|151|M|medical emergency. For information about enrolling in MedicAlert,||
6046|152|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6046|153|B|||
6046|154|A|Information last revised May 2024.||
6046|155|A|Copyright(c) 2025 First Databank, Inc.||
6046|156|B|||
6048|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6048|002|Z|does NOT have all possible information about this product. This||
6048|003|Z|information does not assure that this product is safe, effective,||
6048|004|Z|or appropriate for you. This information is not individual||
6048|005|Z|medical advice and does not substitute for the advice of your||
6048|006|Z|health care professional. Always ask your health care||
6048|007|Z|professional for complete information about this product and your||
6048|008|Z|specific health needs.||
6048|009|B|||
6048|010|T|NITROGLYCERIN SPRAY - LINGUAL||
6048|011|F|(NYE-troe-GLIS-er-in)||
6048|012|B|||
6048|013|C|COMMON BRAND NAME(S): Nitrolingual||
6048|014|B|||
6048|015|U|USES:  This medication is used to relieve chest pain (angina) in||
6048|016|U|people that have a certain heart condition (coronary artery||
6048|017|U|disease). It may also be used before physical activities (such as||
6048|018|U|exercise, sexual activity) to help prevent chest pain.||
6048|019|U|   Nitroglycerin belongs to a class of drugs known as nitrates.||
6048|020|U|Angina occurs when the heart muscle is not getting enough blood.||
6048|021|U|This drug works by relaxing and widening blood vessels so blood||
6048|022|U|can flow more easily to the heart.||
6048|023|B|||
6048|024|H|HOW TO USE:  Ask your doctor now for exact instructions on how to||
6048|025|H|use your nitroglycerin and when to call for emergency medical||
6048|026|H|help (911).||
6048|027|H|   Read the Patient Information Leaflet available from your||
6048|028|H|pharmacist. Consult your doctor or pharmacist if you have any||
6048|029|H|questions.||
6048|030|H|   Before using this medication for the first time, spray the||
6048|031|H|pump into the air away from yourself, others, or open flame. This||
6048|032|H|is known as priming the pump. The number of times you need to||
6048|033|H|spray the pump to prime it depends on your brand. If you have not||
6048|034|H|used this medication for 6 weeks or more, you will need to prime||
6048|035|H|it again before use. Do not shake the container.||
6048|036|H|   Sit down before using this medication. Remove the plastic||
6048|037|H|cover. Hold the container upright with your finger on top of the||
6048|038|H|grooved button. Open your mouth, and bring the container as close||
6048|039|H|to your mouth as possible. Press the button to spray the||
6048|040|H|medication onto or under your tongue. Use 1 to 2 sprays as||
6048|041|H|directed by your doctor, then close your mouth. Do not inhale or||
6048|042|H|swallow the spray. Avoid eating, spitting, or rinsing your mouth||
6048|043|H|for 5 to 10 minutes after spraying.||
6048|044|H|   If you are using this medication to prevent chest pain before||
6048|045|H|physical activities, use it 5 to 10 minutes before the activity.||
6048|046|H|   If you are using this medication to relieve chest pain once it||
6048|047|H|occurs, use it as soon as possible. If your chest pain has not||
6048|048|H|improved or if it has worsened 5 minutes after you use this drug,||
6048|049|H|call emergency medical help (911). After calling the emergency||
6048|050|H|number, use another spray. Five minutes after the second spray,||
6048|051|H|if you still have chest pain and the ambulance has not arrived,||
6048|052|H|use a third spray. If your chest pain is not gone after 15||
6048|053|H|minutes and 3 doses of nitroglycerin, call emergency medical help||
6048|054|H|(911) if you have not called already. Do not use more than 3||
6048|055|H|sprays during an attack unless directed by your doctor.||
6048|056|H|   Periodically check the level of medication in the container so||
6048|057|H|you know when you need to order more medication.||
6048|058|B|||
6048|059|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, nausea, and||
6048|060|S|flushing may occur. If any of these effects last or get worse,||
6048|061|S|tell your doctor or pharmacist promptly.||
6048|062|S|   Headache is often a sign that this medication is working. Your||
6048|063|S|doctor may recommend treating headaches with an over-the-counter||
6048|064|S|pain reliever (such as acetaminophen, aspirin). If the headaches||
6048|065|S|continue or become severe, tell your doctor promptly.||
6048|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
6048|067|S|slowly when rising from a sitting or lying position.||
6048|068|S|   Remember that this medication has been prescribed because your||
6048|069|S|doctor has judged that the benefit to you is greater than the||
6048|070|S|risk of side effects. Many people using this medication do not||
6048|071|S|have serious side effects.||
6048|072|S|   Tell your doctor right away if you have any serious side||
6048|073|S|effects, including: fainting, fast/irregular/pounding heartbeat.||
6048|074|S|   A very serious allergic reaction to this drug is rare.||
6048|075|S|However, get medical help right away if you notice any symptoms||
6048|076|S|of a serious allergic reaction, including: rash, itching/swelling||
6048|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6048|078|S|breathing.||
6048|079|S|   This is not a complete list of possible side effects. If you||
6048|080|S|notice other effects not listed above, contact your doctor or||
6048|081|S|pharmacist.||
6048|082|S|   In the US -||
6048|083|S|   Call your doctor for medical advice about side effects. You||
6048|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6048|085|S|www.fda.gov/medwatch.||
6048|086|S|   In Canada - Call your doctor for medical advice about side||
6048|087|S|effects. You may report side effects to Health Canada at||
6048|088|S|1-866-234-2345.||
6048|089|B|||
6048|090|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6048|091|P|pharmacist if you are allergic to it; or to similar drugs (such||
6048|092|P|as isosorbide mononitrate); or to nitrites; or if you have any||
6048|093|P|other allergies. This product may contain inactive ingredients,||
6048|094|P|which can cause allergic reactions or other problems. Talk to||
6048|095|P|your pharmacist for more details.||
6048|096|P|   Before using this medication, tell your doctor or pharmacist||
6048|097|P|your medical history, especially of: recent head injury, anemia,||
6048|098|P|low blood pressure, dehydration, other heart problems (such as||
6048|099|P|recent heart attack).||
6048|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6048|101|P|can make you more dizzy. Do not drive, use machinery, or do||
6048|102|P|anything that needs alertness until you can do it safely. Limit||
6048|103|P|alcoholic beverages. Talk to your doctor if you are using||
6048|104|P|marijuana (cannabis).||
6048|105|P|   Before having surgery, tell your doctor or dentist about all||
6048|106|P|the products you use (including prescription drugs,||
6048|107|P|nonprescription drugs, and herbal products).||
6048|108|P|   Older adults may be more sensitive to the side effects of this||
6048|109|P|medication, especially dizziness and lightheadedness which could||
6048|110|P|increase the risk of falls.||
6048|111|P|   During pregnancy, this medication should be used only when||
6048|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
6048|113|P|   It is unknown if this medication passes into breast milk or if||
6048|114|P|it may harm a nursing infant. Consult your doctor before||
6048|115|P|breastfeeding.||
6048|116|B|||
6048|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6048|118|I|medications work or increase your risk for serious side effects.||
6048|119|I|This document does not contain all possible drug interactions.||
6048|120|I|Keep a list of all the products you use (including||
6048|121|I|prescription/nonprescription drugs and herbal products) and share||
6048|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
6048|123|I|the dosage of any medicines without your doctor's approval.||
6048|124|I|   Some products that may interact with this drug include: drugs||
6048|125|I|used to treat erectile dysfunction-ED or pulmonary hypertension||
6048|126|I|(such as sildenafil, tadalafil), certain drugs to treat migraine||
6048|127|I|headaches (ergot alkaloids such as ergotamine), riociguat,||
6048|128|I|vericiguat.||
6048|129|I|   This medication may interfere with certain lab tests (such as||
6048|130|I|blood cholesterol levels), possibly causing false test results.||
6048|131|I|Make sure lab personnel and all your doctors know you use this||
6048|132|I|drug.||
6048|133|B|||
6048|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6048|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6048|136|O|poison control center right away. US residents can call||
6048|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6048|138|O|Symptoms of overdose may include: slow heartbeat, vision changes,||
6048|139|O|severe nausea/vomiting, sweating, cold/clammy skin, bluish||
6048|140|O|fingers/toes/lips.||
6048|141|B|||
6048|142|N|NOTES:  Do not share this medication with others.||
6048|143|B|||
6048|144|D|MISSED DOSE:  Not applicable.||
6048|145|B|||
6048|146|R|STORAGE:  Store at room temperature away from heat. Keep all||
6048|147|R|medications away from children and pets.||
6048|148|R|   Do not flush medications down the toilet or pour them into a||
6048|149|R|drain unless instructed to do so. Properly discard this product||
6048|150|R|when it is expired or no longer needed. Consult your pharmacist||
6048|151|R|or local waste disposal company.||
6048|152|B|||
6048|153|M|MEDICAL ALERT:  Your condition can cause complications in a||
6048|154|M|medical emergency. For information about enrolling in MedicAlert,||
6048|155|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6048|156|B|||
6048|157|A|Information last revised January 2025.||
6048|158|A|Copyright(c) 2025 First Databank, Inc.||
6048|159|B|||
6049|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6049|002|Z|does NOT have all possible information about this product. This||
6049|003|Z|information does not assure that this product is safe, effective,||
6049|004|Z|or appropriate for you. This information is not individual||
6049|005|Z|medical advice and does not substitute for the advice of your||
6049|006|Z|health care professional. Always ask your health care||
6049|007|Z|professional for complete information about this product and your||
6049|008|Z|specific health needs.||
6049|009|B|||
6049|010|T|MEFENAMIC ACID - ORAL||
6049|011|F|(MEF-e-NAM-ik AS-id)||
6049|012|B|||
6049|013|C|COMMON BRAND NAME(S): Ponstel||
6049|014|B|||
6049|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
6049|016|W|mefenamic acid) may rarely increase the risk of a heart attack or||
6049|017|W|stroke. This effect can happen at any time while taking this drug||
6049|018|W|but is more likely if you take it for a long time. The risk may||
6049|019|W|be greater in older adults or if you have heart disease or||
6049|020|W|increased risk for heart disease (for example, due to smoking,||
6049|021|W|family history of heart disease, or conditions such as high blood||
6049|022|W|pressure or diabetes). Do not take this drug right before or||
6049|023|W|after heart bypass surgery (CABG).||
6049|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
6049|025|W|bleeding from the stomach or intestines. This effect can occur||
6049|026|W|without warning symptoms at any time while taking this drug.||
6049|027|W|Older adults may be at higher risk for this effect.||
6049|028|W|   Stop taking mefenamic acid and get medical help right away if||
6049|029|W|you notice any of these rare but serious side effects:||
6049|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
6049|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
6049|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
6049|033|W|side of the body, trouble speaking, sudden vision changes.||
6049|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
6049|035|W|of taking this drug.||
6049|036|B|||
6049|037|U|USES:  See also Warning section.||
6049|038|U|   Mefenamic acid is used for the short-term relief of mild to||
6049|039|U|moderate pain from various conditions such as headache, dental||
6049|040|U|pain, menstrual cramps, and muscle aches.||
6049|041|U|   Mefenamic acid is known as a nonsteroidal anti-inflammatory||
6049|042|U|drug (NSAID). It works by blocking your body's production of||
6049|043|U|certain natural substances that cause inflammation. This effect||
6049|044|U|helps to decrease swelling, pain, or fever.||
6049|045|B|||
6049|046|V|OTHER USES:  This section contains uses of this drug that are not||
6049|047|V|listed in the approved professional labeling for the drug but||
6049|048|V|that may be prescribed by your health care professional. Use this||
6049|049|V|drug for a condition that is listed in this section only if it||
6049|050|V|has been so prescribed by your health care professional.||
6049|051|V|   This medication may also be used for arthritis and gout||
6049|052|V|attacks.||
6049|053|B|||
6049|054|H|HOW TO USE:  Read the Medication Guide provided by your||
6049|055|H|pharmacist before you start taking mefenamic acid and each time||
6049|056|H|you get a refill. If you have any questions, ask your doctor or||
6049|057|H|pharmacist.||
6049|058|H|   Take this medication by mouth as directed by your doctor,||
6049|059|H|usually 4 times a day. Take this medication with a full glass of||
6049|060|H|water (8 ounces/240 milliliters) unless your doctor directs you||
6049|061|H|otherwise. Do not lie down for at least 10 minutes after taking||
6049|062|H|this medication. If stomach upset occurs while taking this||
6049|063|H|medication, take it with food or milk. Do not take mefenamic acid||
6049|064|H|with antacids unless directed by your doctor. Certain antacids||
6049|065|H|may change the amount of mefenamic acid absorbed by the body.||
6049|066|H|   The dosage and length of treatment are based on your medical||
6049|067|H|condition and response to treatment. To reduce your risk of||
6049|068|H|stomach bleeding and other side effects, take this medication at||
6049|069|H|the lowest effective dose for the shortest possible time. Do not||
6049|070|H|increase your dose or use this drug more often or for longer than||
6049|071|H|prescribed. This medication usually should not be taken for more||
6049|072|H|than 7 days at a time. Discuss the risks and benefits with your||
6049|073|H|doctor or pharmacist.||
6049|074|H|   If you are taking this drug "as needed" (not on a regular||
6049|075|H|schedule), remember that pain medications work best if they are||
6049|076|H|used as the first signs of pain occur. If you wait until the pain||
6049|077|H|has worsened, the medicine may not work as well.||
6049|078|H|   If you are using this medication for painful periods, take||
6049|079|H|your first dose as soon as your period starts, or pain begins.||
6049|080|H|Usually, you will only need to take it for the first 2 to 3 days||
6049|081|H|of your period.||
6049|082|H|   Tell your doctor if your condition lasts or gets worse.||
6049|083|B|||
6049|084|S|SIDE EFFECTS:  See also Warning section.||
6049|085|S|   Upset stomach, nausea, diarrhea, dizziness, drowsiness, or||
6049|086|S|blurred vision may occur. If any of these effects last or get||
6049|087|S|worse, tell your doctor or pharmacist promptly.||
6049|088|S|   Remember that this medication has been prescribed because your||
6049|089|S|doctor has judged that the benefit to you is greater than the||
6049|090|S|risk of side effects. Many people using this medication do not||
6049|091|S|have serious side effects.||
6049|092|S|   This medication may raise your blood pressure. Check your||
6049|093|S|blood pressure regularly and tell your doctor if the results are||
6049|094|S|high.||
6049|095|S|   Tell your doctor right away if you have any serious side||
6049|096|S|effects, including: hearing changes (such as ringing in the||
6049|097|S|ears), mental/mood changes, easy bleeding/bruising,||
6049|098|S|difficult/painful swallowing, signs of kidney problems (such as||
6049|099|S|change in the amount of urine, pink/bloody urine), symptoms of||
6049|100|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
6049|101|S|unusual/sudden weight gain).||
6049|102|S|   Mefenamic acid may rarely cause serious (possibly fatal) liver||
6049|103|S|disease. Get medical help right away if you have any symptoms of||
6049|104|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
6049|105|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
6049|106|S|urine.||
6049|107|S|   A very serious allergic reaction to this drug is rare.||
6049|108|S|However, get medical help right away if you notice any symptoms||
6049|109|S|of a serious allergic reaction, including: fever, swollen lymph||
6049|110|S|nodes, rash, itching/swelling (especially of the||
6049|111|S|face/tongue/throat), severe dizziness, trouble breathing.||
6049|112|S|   This is not a complete list of possible side effects. If you||
6049|113|S|notice other effects not listed above, contact your doctor or||
6049|114|S|pharmacist.||
6049|115|S|   In the US -||
6049|116|S|   Call your doctor for medical advice about side effects. You||
6049|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6049|118|S|www.fda.gov/medwatch.||
6049|119|S|   In Canada - Call your doctor for medical advice about side||
6049|120|S|effects. You may report side effects to Health Canada at||
6049|121|S|1-866-234-2345.||
6049|122|B|||
6049|123|P|PRECAUTIONS:  See also Warning section.||
6049|124|P|   Before taking mefenamic acid, tell your doctor or pharmacist||
6049|125|P|if you are allergic to it; or to aspirin or other NSAIDs (such as||
6049|126|P|ibuprofen, naproxen, celecoxib); or if you have any other||
6049|127|P|allergies. This product may contain inactive ingredients, which||
6049|128|P|can cause allergic reactions or other problems. Talk to your||
6049|129|P|pharmacist for more details.||
6049|130|P|   Before using this medication, tell your doctor or pharmacist||
6049|131|P|your medical history, especially of: asthma (including a history||
6049|132|P|of worsening breathing after taking aspirin or other NSAIDs),||
6049|133|P|bleeding/clotting problems, blood disorders (such as anemia),||
6049|134|P|growths in the nose (nasal polyps), heart disease (such as||
6049|135|P|previous heart attack), high blood fat levels||
6049|136|P|(cholesterol/triglyceride), high blood pressure, liver disease,||
6049|137|P|stroke, swelling (edema, fluid retention),||
6049|138|P|stomach/intestinal/esophagus problems (such as bleeding,||
6049|139|P|heartburn, ulcers).||
6049|140|P|   Kidney problems can sometimes occur with the use of NSAID||
6049|141|P|medications, including mefenamic acid. Problems are more likely||
6049|142|P|to occur if you are dehydrated, have heart failure or kidney||
6049|143|P|disease, are an older adult, or if you take certain medications||
6049|144|P|(see also Drug Interactions section). Drink plenty of fluids as||
6049|145|P|directed by your doctor to prevent dehydration and tell your||
6049|146|P|doctor right away if you have pink/bloody urine or any unusual||
6049|147|P|change in the amount of urine.||
6049|148|P|   This drug may make you dizzy, drowsy, or cause blurred vision.||
6049|149|P|Alcohol or marijuana (cannabis) can worsen these effects. Do not||
6049|150|P|drive, use machinery, or do anything that needs alertness or||
6049|151|P|clear vision until you can do it safely. Limit alcoholic||
6049|152|P|beverages. Talk to your doctor if you are using marijuana||
6049|153|P|(cannabis).||
6049|154|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
6049|155|P|and tobacco, especially when combined with this medicine, may||
6049|156|P|increase your risk for stomach bleeding. Limit alcohol and stop||
6049|157|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
6049|158|P|may safely drink.||
6049|159|P|   This medication may make you more sensitive to the sun. Limit||
6049|160|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
6049|161|P|sunscreen and wear protective clothing when outdoors. Tell your||
6049|162|P|doctor right away if you get sunburned or have skin||
6049|163|P|blisters/redness.||
6049|164|P|   Before having surgery, tell your doctor or dentist about all||
6049|165|P|the products you use (including prescription drugs,||
6049|166|P|nonprescription drugs, and herbal products).||
6049|167|P|   Older adults may be at greater risk for stomach/intestinal||
6049|168|P|bleeding, kidney problems, heart attack, and stroke while using||
6049|169|P|this drug.||
6049|170|P|   Before using this medication, women of childbearing age should||
6049|171|P|talk with their doctor(s) about the benefits and risks. Tell your||
6049|172|P|doctor if you are pregnant or if you plan to become pregnant.||
6049|173|P|This medication may harm an unborn baby and cause problems with||
6049|174|P|normal labor/delivery. It is not recommended for use in pregnancy||
6049|175|P|from 20 weeks until delivery. If your doctor decides that you||
6049|176|P|need to use this medication between 20 and 30 weeks of pregnancy,||
6049|177|P|you should use the lowest effective dose for the shortest||
6049|178|P|possible time. You should not use this medication after 30 weeks||
6049|179|P|of pregnancy.||
6049|180|P|   This drug passes into breast milk. Consult your doctor before||
6049|181|P|breastfeeding.||
6049|182|B|||
6049|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6049|184|I|medications work or increase your risk for serious side effects.||
6049|185|I|This document does not contain all possible drug interactions.||
6049|186|I|Keep a list of all the products you use (including||
6049|187|I|prescription/nonprescription drugs and herbal products) and share||
6049|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
6049|189|I|the dosage of any medicines without your doctor's approval.||
6049|190|I|   Some products that may interact with this drug are: aliskiren,||
6049|191|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
6049|192|I|receptor blockers (such as losartan, valsartan), cidofovir,||
6049|193|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
6049|194|I|methotrexate, "water pills" (diuretics such as furosemide).||
6049|195|I|   This medication may increase the risk of bleeding when taken||
6049|196|I|with other drugs that also may cause bleeding. Examples include||
6049|197|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
6049|198|I|dabigatran/enoxaparin/warfarin, among others.||
6049|199|I|   Check all prescription and nonprescription medicine labels||
6049|200|I|carefully since many medications contain pain relievers/fever||
6049|201|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
6049|202|I|naproxen). These drugs are similar to mefenamic acid and may||
6049|203|I|increase your risk of side effects if taken together. However, if||
6049|204|I|your doctor has told you to take low-dose aspirin to prevent||
6049|205|I|heart attack or stroke (usually 81-162 milligrams a day), you||
6049|206|I|should keep taking the aspirin unless your doctor tells you not||
6049|207|I|to. Ask your doctor or pharmacist for more details.||
6049|208|I|   This medication may interfere with certain lab tests (such as||
6049|209|I|urine bile test), possibly causing false test results. Make sure||
6049|210|I|lab personnel and all your doctors know you use this drug.||
6049|211|B|||
6049|212|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6049|213|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6049|214|O|poison control center right away. US residents can call||
6049|215|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6049|216|O|Symptoms of overdose may include: severe stomach pain,||
6049|217|O|slow/shallow breathing, extreme drowsiness.||
6049|218|B|||
6049|219|N|NOTES:  Do not share this medication with others.||
6049|220|N|   Lab and/or medical tests (such as complete blood count,||
6049|221|N|liver/kidney function, blood pressure) may be done while you are||
6049|222|N|using this medication. Keep all medical and lab appointments.||
6049|223|N|Consult your doctor for more details.||
6049|224|B|||
6049|225|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
6049|226|D|(not just "as needed") and you miss a dose, take it as soon as||
6049|227|D|you remember. If it is near the time of the next dose, skip the||
6049|228|D|missed dose. Take your next dose at the regular time. Do not||
6049|229|D|double the dose to catch up.||
6049|230|B|||
6049|231|R|STORAGE:  Store at room temperature away from light and moisture.||
6049|232|R|Do not store in the bathroom. Keep all medications away from||
6049|233|R|children and pets.||
6049|234|R|   Do not flush medications down the toilet or pour them into a||
6049|235|R|drain unless instructed to do so. Properly discard this product||
6049|236|R|when it is expired or no longer needed. Consult your pharmacist||
6049|237|R|or local waste disposal company.||
6049|238|B|||
6049|239|A|Information last revised September 2024.||
6049|240|A|Copyright(c) 2025 First Databank, Inc.||
6049|241|B|||
6051|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6051|002|Z|does NOT have all possible information about this product. This||
6051|003|Z|information does not assure that this product is safe, effective,||
6051|004|Z|or appropriate for you. This information is not individual||
6051|005|Z|medical advice and does not substitute for the advice of your||
6051|006|Z|health care professional. Always ask your health care||
6051|007|Z|professional for complete information about this product and your||
6051|008|Z|specific health needs.||
6051|009|B|||
6051|010|T|PIZOTIFEN - ORAL||
6051|011|F|(pizz-oh-TIFF-en)||
6051|012|B|||
6051|013|U|USES:  This medication is used to prevent a certain type of||
6051|014|U|headache (vascular headaches such as migraine headaches). It||
6051|015|U|helps to reduce the frequency and severity of your headaches.||
6051|016|U|   This medication should not be used to treat a migraine||
6051|017|U|headache after it has started or to prevent other types of||
6051|018|U|headaches such as tension headaches.||
6051|019|B|||
6051|020|H|HOW TO USE:  Take this medication by mouth with or without food||
6051|021|H|as directed by your doctor, usually 3 times daily. Your doctor||
6051|022|H|may direct you to start with 1 dose at bedtime, then slowly||
6051|023|H|increase your dose.||
6051|024|H|   The dosage is based on your medical condition and response to||
6051|025|H|treatment.||
6051|026|H|   Do not suddenly stop taking this medication without consulting||
6051|027|H|your doctor. "Rebound headaches" may occur when the drug is||
6051|028|H|suddenly stopped. Your dose should be gradually decreased over a||
6051|029|H|2-week period.||
6051|030|H|   When used for an extended period, this medication may not work||
6051|031|H|as well and may require different dosing. Talk with your doctor||
6051|032|H|if this medication stops working well.||
6051|033|H|   It may take up to 4 weeks to see whether the medication will||
6051|034|H|be effective for you. Tell your doctor if your headaches last,||
6051|035|H|get worse, or increase in number.||
6051|036|B|||
6051|037|S|SIDE EFFECTS:  Drowsiness, increased appetite, weight gain,||
6051|038|S|tiredness, nausea, headache, or dry mouth may occur. If any of||
6051|039|S|these effects last or get worse, tell your doctor or pharmacist||
6051|040|S|promptly.||
6051|041|S|   Remember that this medication has been prescribed because your||
6051|042|S|doctor has judged that the benefit to you is greater than the||
6051|043|S|risk of side effects. Many people using this medication do not||
6051|044|S|have serious side effects.||
6051|045|S|   Tell your doctor right away if you have any serious side||
6051|046|S|effects, including: nausea/vomiting that doesn't stop, eye pain,||
6051|047|S|dark urine, severe stomach/abdominal pain, yellowing eyes/skin,||
6051|048|S|vision changes, mental/mood changes (such as confusion,||
6051|049|S|depression, nervousness), swelling of the ankles/feet, decreased||
6051|050|S|sexual ability.||
6051|051|S|   A very serious allergic reaction to this drug is rare.||
6051|052|S|However, get medical help right away if you notice any symptoms||
6051|053|S|of a serious allergic reaction, including: rash, itching/swelling||
6051|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6051|055|S|breathing.||
6051|056|S|   This is not a complete list of possible side effects. If you||
6051|057|S|notice other effects not listed above, contact your doctor or||
6051|058|S|pharmacist.||
6051|059|S|   In the US -||
6051|060|S|   Call your doctor for medical advice about side effects. You||
6051|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6051|062|S|www.fda.gov/medwatch.||
6051|063|S|   In Canada - Call your doctor for medical advice about side||
6051|064|S|effects. You may report side effects to Health Canada at||
6051|065|S|1-866-234-2345.||
6051|066|B|||
6051|067|P|PRECAUTIONS:  Before taking pizotifen, tell your doctor or||
6051|068|P|pharmacist if you are allergic to it; or if you have any other||
6051|069|P|allergies. This product may contain inactive ingredients, which||
6051|070|P|can cause allergic reactions or other problems. Talk to your||
6051|071|P|pharmacist for more details.||
6051|072|P|   Before using this drug, tell your doctor your medical history,||
6051|073|P|especially of: stomach/intestinal blockage, glaucoma||
6051|074|P|(narrow-angle), difficulty urinating (such as due to enlarged||
6051|075|P|prostate), breathing problems (such as asthma, emphysema),||
6051|076|P|diabetes, heart/blood vessel disease (such as stroke, coronary||
6051|077|P|artery disease, irregular heart rhythm), high blood pressure||
6051|078|P|(hypertension), overactive thyroid (hyperthyroidism), kidney||
6051|079|P|disease, liver disease.||
6051|080|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6051|081|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6051|082|P|machinery, or do anything that needs alertness until you can do||
6051|083|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6051|084|P|are using marijuana (cannabis).||
6051|085|P|   Before having surgery, tell your doctor or dentist about all||
6051|086|P|the products you use (including prescription drugs,||
6051|087|P|nonprescription drugs, and herbal products).||
6051|088|P|   During pregnancy, this medication should be used only when||
6051|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
6051|090|P|   This drug may pass into breast milk and could have undesirable||
6051|091|P|effects on a nursing infant. Breastfeeding is not recommended||
6051|092|P|while using this drug. Consult your doctor before breastfeeding.||
6051|093|B|||
6051|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6051|095|I|medications work or increase your risk for serious side effects.||
6051|096|I|This document does not contain all possible drug interactions.||
6051|097|I|Keep a list of all the products you use (including||
6051|098|I|prescription/nonprescription drugs and herbal products) and share||
6051|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
6051|100|I|the dosage of any medicines without your doctor's approval.||
6051|101|I|   Some products that may interact with this drug are:||
6051|102|I|antihistamines applied to the skin (such as diphenhydramine||
6051|103|I|cream, ointment, spray).||
6051|104|I|   Taking MAO inhibitors with this medication may cause a serious||
6051|105|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
6051|106|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
6051|107|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
6051|108|I|selegiline, tranylcypromine) during treatment with this||
6051|109|I|medication. Most MAO inhibitors should also not be taken for two||
6051|110|I|weeks before treatment with this medication. Ask your doctor when||
6051|111|I|to start or stop taking this medication.||
6051|112|I|   Tell your doctor or pharmacist if you are taking other||
6051|113|I|products that cause drowsiness such as opioid pain or cough||
6051|114|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6051|115|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
6051|116|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6051|117|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6051|118|I|diphenhydramine).||
6051|119|I|   Check the labels on all your medicines (such as allergy or||
6051|120|I|cough-and-cold products) because they may contain ingredients||
6051|121|I|that cause drowsiness. Ask your pharmacist about using those||
6051|122|I|products safely.||
6051|123|B|||
6051|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6051|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6051|126|O|poison control center right away. US residents can call||
6051|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6051|128|O|Symptoms of overdose may include: extreme drowsiness, fast||
6051|129|O|heartbeat, nausea, loss of coordination.||
6051|130|B|||
6051|131|N|NOTES:  Do not share this medication with others.||
6051|132|N|   Lab and/or medical tests (such as kidney/liver function) may||
6051|133|N|be done while you are taking this medication. Keep all medical||
6051|134|N|and lab appointments. Consult your doctor for more details.||
6051|135|B|||
6051|136|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6051|137|D|remember. If it is near the time of the next dose, skip the||
6051|138|D|missed dose. Take your next dose at the regular time. Do not||
6051|139|D|double the dose to catch up.||
6051|140|B|||
6051|141|R|STORAGE:  Store at room temperature away from light and moisture.||
6051|142|R|Do not store in the bathroom. Keep all medications away from||
6051|143|R|children and pets.||
6051|144|R|   Do not flush medications down the toilet or pour them into a||
6051|145|R|drain unless instructed to do so. Properly discard this product||
6051|146|R|when it is expired or no longer needed. Consult your pharmacist||
6051|147|R|or local waste disposal company.||
6051|148|B|||
6051|149|A|Information last revised May 2024.||
6051|150|A|Copyright(c) 2025 First Databank, Inc.||
6051|151|B|||
6052|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6052|002|Z|does NOT have all possible information about this product. This||
6052|003|Z|information does not assure that this product is safe, effective,||
6052|004|Z|or appropriate for you. This information is not individual||
6052|005|Z|medical advice and does not substitute for the advice of your||
6052|006|Z|health care professional. Always ask your health care||
6052|007|Z|professional for complete information about this product and your||
6052|008|Z|specific health needs.||
6052|009|B|||
6052|010|T|CLOTRIMAZOLE LOZENGE - MUCOUS MEMBRANE (ORAL)||
6052|011|F|(kloe-TRIM-a-zole)||
6052|012|B|||
6052|013|C|COMMON BRAND NAME(S): Mycelex||
6052|014|B|||
6052|015|U|USES:  Clotrimazole lozenge is only approved for the treatment of||
6052|016|U|fungal infections of the mouth or throat. It may also be used to||
6052|017|U|prevent these infections in patients receiving treatments that||
6052|018|U|may weaken the body's immune system (such as chemotherapy).||
6052|019|U|Clotrimazole is known as an azole antifungal agent. It works by||
6052|020|U|stopping the growth of fungus.||
6052|021|B|||
6052|022|H|HOW TO USE:  Use this medication orally by placing it in your||
6052|023|H|mouth and allowing it to slowly dissolve over 15 to 30 minutes.||
6052|024|H|Do not chew or swallow the lozenge whole. Do not eat or drink||
6052|025|H|while this medication is in your mouth. If your child cannot||
6052|026|H|safely use this tablet, ask your doctor or pharmacist for advice.||
6052|027|H|   If you are using this medication to treat an oral fungal||
6052|028|H|infection, use it as directed by your doctor, usually five times||
6052|029|H|daily. If you have trouble swallowing or have pain while||
6052|030|H|swallowing, consult your doctor. Other medications may be needed.||
6052|031|H|   Continue to use this medication until the full prescribed||
6052|032|H|amount is finished, even if symptoms disappear after a few days.||
6052|033|H|Stopping the medication too early may result in a return of the||
6052|034|H|infection. Tell your doctor if your condition lasts or gets||
6052|035|H|worse.||
6052|036|H|   If you are using this medication to prevent an oral fungal||
6052|037|H|infection, use it as directed by your doctor, usually three times||
6052|038|H|daily. Continue to use it until the full number of days||
6052|039|H|prescribed.||
6052|040|H|   Antifungals work best when the amount of medicine in your body||
6052|041|H|is kept at a constant level. Take this drug at evenly spaced||
6052|042|H|intervals.||
6052|043|B|||
6052|044|S|SIDE EFFECTS:  Nausea, vomiting, mild itching, or an unpleasant||
6052|045|S|sensation in the mouth may occur. If any of these effects last or||
6052|046|S|get worse, notify your doctor or pharmacist promptly.||
6052|047|S|   Remember that this medication has been prescribed because your||
6052|048|S|doctor has judged that the benefit to you is greater than the||
6052|049|S|risk of side effects. Many people using this medication do not||
6052|050|S|have serious side effects.||
6052|051|S|   A very serious allergic reaction to this drug is rare.||
6052|052|S|However, get medical help right away if you notice any symptoms||
6052|053|S|of a serious allergic reaction, including: rash, itching/swelling||
6052|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6052|055|S|breathing.||
6052|056|S|   This is not a complete list of possible side effects. If you||
6052|057|S|notice other effects not listed above, contact your doctor or||
6052|058|S|pharmacist.||
6052|059|S|   In the US -||
6052|060|S|   Call your doctor for medical advice about side effects. You||
6052|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6052|062|S|www.fda.gov/medwatch.||
6052|063|S|   In Canada - Call your doctor for medical advice about side||
6052|064|S|effects. You may report side effects to Health Canada at||
6052|065|S|1-866-234-2345.||
6052|066|B|||
6052|067|P|PRECAUTIONS:  Before taking clotrimazole lozenges, tell your||
6052|068|P|doctor or pharmacist if you are allergic to clotrimazole; or to||
6052|069|P|other azole antifungal drugs (such as ketoconazole); or if you||
6052|070|P|have any other allergies. This product may contain inactive||
6052|071|P|ingredients, which can cause allergic reactions or other||
6052|072|P|problems. Talk to your pharmacist for more details.||
6052|073|P|   Before using this medication, tell your doctor or pharmacist||
6052|074|P|your medical history, especially of: liver disease.||
6052|075|P|   Before having surgery, tell your doctor or dentist about all||
6052|076|P|the products you use (including prescription drugs,||
6052|077|P|nonprescription drugs, and herbal products).||
6052|078|P|   During pregnancy, this medication should be used only when||
6052|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
6052|080|P|   It is unknown if this drug passes into breast milk. Consult||
6052|081|P|your doctor before breastfeeding.||
6052|082|B|||
6052|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6052|084|I|medications work or increase your risk for serious side effects.||
6052|085|I|This document does not contain all possible drug interactions.||
6052|086|I|Keep a list of all the products you use (including||
6052|087|I|prescription/nonprescription drugs and herbal products) and share||
6052|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
6052|089|I|the dosage of any medicines without your doctor's approval.||
6052|090|B|||
6052|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6052|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6052|093|O|poison control center right away. US residents can call||
6052|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6052|095|B|||
6052|096|N|NOTES:  Do not share this medication with others.||
6052|097|N|   This medication has been prescribed for your current condition||
6052|098|N|only. Do not use it later for another infection unless your||
6052|099|N|doctor tells you to.||
6052|100|N|   Lab and/or medical tests (such as liver function) may be done||
6052|101|N|while you are taking this medication. Keep all medical and lab||
6052|102|N|appointments. Consult your doctor for more details.||
6052|103|B|||
6052|104|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6052|105|D|If it is near the time of the next dose, skip the missed dose.||
6052|106|D|Use your next dose at the regular time. Do not double the dose to||
6052|107|D|catch up.||
6052|108|B|||
6052|109|R|STORAGE:  Store at room temperature away from heat and moisture.||
6052|110|R|Do not freeze. Do not store in the bathroom. Keep all medications||
6052|111|R|away from children and pets.||
6052|112|R|   Do not flush medications down the toilet or pour them into a||
6052|113|R|drain unless instructed to do so. Properly discard this product||
6052|114|R|when it is expired or no longer needed. Consult your pharmacist||
6052|115|R|or local waste disposal company.||
6052|116|B|||
6052|117|A|Information last revised May 2024.||
6052|118|A|Copyright(c) 2025 First Databank, Inc.||
6052|119|B|||
6053|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6053|002|Z|does NOT have all possible information about this product. This||
6053|003|Z|information does not assure that this product is safe, effective,||
6053|004|Z|or appropriate for you. This information is not individual||
6053|005|Z|medical advice and does not substitute for the advice of your||
6053|006|Z|health care professional. Always ask your health care||
6053|007|Z|professional for complete information about this product and your||
6053|008|Z|specific health needs.||
6053|009|B|||
6053|010|T|PROCHLORPERAZINE - ORAL||
6053|011|F|(PROE-klor-PER-a-zeen)||
6053|012|B|||
6053|013|C|COMMON BRAND NAME(S): Compazine||
6053|014|B|||
6053|015|W|WARNING:  There may be a slightly increased risk of serious,||
6053|016|W|possibly fatal side effects (such as heart failure,||
6053|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
6053|018|W|by older adults with dementia. This medication is not approved||
6053|019|W|for the treatment of dementia-related behavior problems. Discuss||
6053|020|W|the risks and benefits of this medication with the doctor.||
6053|021|B|||
6053|022|U|USES:  This medication is used to treat severe nausea and||
6053|023|U|vomiting from certain causes (for example, after surgery or||
6053|024|U|cancer treatment). Prochlorperazine belongs to a class of drugs||
6053|025|U|known as phenothiazines.||
6053|026|U|   This medication is not recommended for use in children younger||
6053|027|U|than 2 years or in children going through surgery.||
6053|028|B|||
6053|029|H|HOW TO USE:  Take this medication by mouth with or without food||
6053|030|H|as directed by your doctor, usually 3 to 4 times daily.||
6053|031|H|   The dosage is based on your age, medical condition, and||
6053|032|H|response to treatment. Children's dosage may also be based on||
6053|033|H|weight. Do not increase your dose or take this medication more||
6053|034|H|often than directed.||
6053|035|H|   Tell your doctor if your condition lasts or gets worse.||
6053|036|B|||
6053|037|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, blurred||
6053|038|S|vision, constipation, or dry mouth may occur. If any of these||
6053|039|S|effects last or get worse, tell your doctor or pharmacist||
6053|040|S|promptly.||
6053|041|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
6053|042|S|chips, chew (sugarless) gum, drink water, or use a saliva||
6053|043|S|substitute.||
6053|044|S|   To reduce the risk of dizziness and lightheadedness, get up||
6053|045|S|slowly when rising from a sitting or lying position.||
6053|046|S|   Remember that this medication has been prescribed because your||
6053|047|S|doctor has judged that the benefit to you is greater than the||
6053|048|S|risk of side effects. Many people using this medication do not||
6053|049|S|have serious side effects.||
6053|050|S|   Tell your doctor right away if you have any serious side||
6053|051|S|effects, including: nausea/vomiting that doesn't stop,||
6053|052|S|mental/mood changes (such as agitation, restlessness),||
6053|053|S|unusual/uncontrolled movements (such as fixed upward stare, neck||
6053|054|S|twisting, tongue movements, muscle spasms), shaking (tremor),||
6053|055|S|difficulty urinating, enlarged/tender breasts, unusual breast||
6053|056|S|milk production, weakness, easy bleeding/bruising, signs of||
6053|057|S|infection (such as sore throat that doesn't go away, fever,||
6053|058|S|chills), severe stomach/abdominal pain, yellowing eyes/skin.||
6053|059|S|   Get medical help right away if you have any very serious side||
6053|060|S|effects, including: seizures.||
6053|061|S|   This medication may rarely cause a very serious condition||
6053|062|S|called neuroleptic malignant syndrome (NMS). Get medical help||
6053|063|S|right away if you have any of the following symptoms: fever,||
6053|064|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
6053|065|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
6053|066|S|signs of kidney problems (such as change in the amount of urine).||
6053|067|S|   A very serious allergic reaction to this drug is rare.||
6053|068|S|However, get medical help right away if you notice any symptoms||
6053|069|S|of a serious allergic reaction, including: rash, itching/swelling||
6053|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6053|071|S|breathing.||
6053|072|S|   This is not a complete list of possible side effects. If you||
6053|073|S|notice other effects not listed above, contact your doctor or||
6053|074|S|pharmacist.||
6053|075|S|   In the US -||
6053|076|S|   Call your doctor for medical advice about side effects. You||
6053|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6053|078|S|www.fda.gov/medwatch.||
6053|079|S|   In Canada - Call your doctor for medical advice about side||
6053|080|S|effects. You may report side effects to Health Canada at||
6053|081|S|1-866-234-2345.||
6053|082|B|||
6053|083|P|PRECAUTIONS:  Before taking prochlorperazine, tell your doctor or||
6053|084|P|pharmacist if you are allergic to it; or to other phenothiazines||
6053|085|P|(such as chlorpromazine); or if you have any other allergies.||
6053|086|P|This product may contain inactive ingredients, which can cause||
6053|087|P|allergic reactions or other problems. Talk to your pharmacist for||
6053|088|P|more details.||
6053|089|P|   Before using this medication, tell your doctor or pharmacist||
6053|090|P|your medical history, especially of: breathing problems (such as||
6053|091|P|asthma, chronic obstructive pulmonary disease-COPD), blood/immune||
6053|092|P|system disorders (such as bone marrow depression), high pressure||
6053|093|P|in the eye (glaucoma), heart disease (such as irregular||
6053|094|P|heartbeat), liver disease, kidney disease, certain brain||
6053|095|P|disorders (such as Reye's syndrome, seizures), stomach/intestine||
6053|096|P|problems (such as blockage), difficulty urinating (for example,||
6053|097|P|due to enlarged prostate), a certain adrenal gland tumor||
6053|098|P|(pheochromocytoma).||
6053|099|P|   This drug may make you dizzy or drowsy or blur your vision.||
6053|100|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
6053|101|P|drowsy. Do not drive, use machinery, or do anything that needs||
6053|102|P|alertness or clear vision until you can do it safely. Avoid||
6053|103|P|alcoholic beverages. Talk to your doctor if you are using||
6053|104|P|marijuana (cannabis).||
6053|105|P|   Before having surgery, tell your doctor or dentist about all||
6053|106|P|the products you use (including prescription drugs,||
6053|107|P|nonprescription drugs, and herbal products).||
6053|108|P|   This medication may make you more sensitive to the sun. Limit||
6053|109|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
6053|110|P|sunscreen and wear protective clothing when outdoors. Tell your||
6053|111|P|doctor right away if you get sunburned or have skin||
6053|112|P|blisters/redness.||
6053|113|P|   This medication may make you sweat less, making you more||
6053|114|P|likely to get heat stroke. Avoid doing things that may cause you||
6053|115|P|to overheat, such as hard work or exercise in hot weather, or||
6053|116|P|using hot tubs. When the weather is hot, drink a lot of fluids||
6053|117|P|and dress lightly. If you overheat, quickly look for a place to||
6053|118|P|cool down and rest. Get medical help right away if you have a||
6053|119|P|fever that does not go away, mental/mood changes, headache, or||
6053|120|P|dizziness.||
6053|121|P|   Children may be more sensitive to the side effects of this||
6053|122|P|drug, especially uncontrolled movements. They may be at greater||
6053|123|P|risk when they are sick (such as having viral infection,||
6053|124|P|dehydration).||
6053|125|P|   Older adults may be more sensitive to the side effects of this||
6053|126|P|drug, especially low blood pressure, constipation, urinary||
6053|127|P|problems, and nerve/muscle problems.||
6053|128|P|   During pregnancy, this medication should be used only when||
6053|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
6053|130|P|Babies born to mothers who have used this drug during the last 3||
6053|131|P|months of pregnancy may rarely develop symptoms including muscle||
6053|132|P|stiffness or shakiness, drowsiness, feeding/breathing||
6053|133|P|difficulties, or constant crying. If you notice any of these||
6053|134|P|symptoms in your newborn anytime during their first month, tell||
6053|135|P|the doctor right away.||
6053|136|P|   It is unknown if prochlorperazine passes into breast milk.||
6053|137|P|However, similar drugs pass into breast milk. Consult your doctor||
6053|138|P|before breastfeeding.||
6053|139|B|||
6053|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6053|141|I|medications work or increase your risk for serious side effects.||
6053|142|I|This document does not contain all possible drug interactions.||
6053|143|I|Keep a list of all the products you use (including||
6053|144|I|prescription/nonprescription drugs and herbal products) and share||
6053|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
6053|146|I|the dosage of any medicines without your doctor's approval.||
6053|147|I|   Some products that may interact with this drug include:||
6053|148|I|cabergoline, dofetilide, metoclopramide.||
6053|149|I|   Tell your doctor or pharmacist if you are taking other||
6053|150|I|products that cause drowsiness such as opioid pain or cough||
6053|151|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6053|152|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
6053|153|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6053|154|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6053|155|I|diphenhydramine).||
6053|156|I|   Check the labels on all your medicines (such as allergy or||
6053|157|I|cough-and-cold products) because they may contain ingredients||
6053|158|I|that cause drowsiness. Ask your pharmacist about using those||
6053|159|I|products safely.||
6053|160|I|   This medication may interfere with certain lab tests (such as||
6053|161|I|phenylketonuria, certain pregnancy tests), possibly causing false||
6053|162|I|test results. Make sure lab personnel and all your doctors know||
6053|163|I|you use this drug.||
6053|164|B|||
6053|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6053|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6053|167|O|poison control center right away. US residents can call||
6053|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6053|169|O|Symptoms of overdose may include: mental/mood changes (such as||
6053|170|O|restlessness, agitation), severe drowsiness, seizures, irregular||
6053|171|O|heartbeat.||
6053|172|B|||
6053|173|N|NOTES:  Do not share this medication with others.||
6053|174|N|   Lab and/or medical tests may be done while you are taking this||
6053|175|N|medication. Keep all medical and lab appointments. Consult your||
6053|176|N|doctor for more details.||
6053|177|B|||
6053|178|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6053|179|D|remember. If it is near the time of the next dose, skip the||
6053|180|D|missed dose. Take your next dose at the regular time. Do not||
6053|181|D|double the dose to catch up.||
6053|182|B|||
6053|183|R|STORAGE:  Store at room temperature away from light and moisture.||
6053|184|R|Do not store in the bathroom. Keep all medications away from||
6053|185|R|children and pets.||
6053|186|R|   Do not flush medications down the toilet or pour them into a||
6053|187|R|drain unless instructed to do so. Properly discard this product||
6053|188|R|when it is expired or no longer needed. Consult your pharmacist||
6053|189|R|or local waste disposal company.||
6053|190|B|||
6053|191|A|Information last revised May 2025.||
6053|192|A|Copyright(c) 2025 First Databank, Inc.||
6053|193|B|||
6060|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6060|002|Z|does NOT have all possible information about this product. This||
6060|003|Z|information does not assure that this product is safe, effective,||
6060|004|Z|or appropriate for you. This information is not individual||
6060|005|Z|medical advice and does not substitute for the advice of your||
6060|006|Z|health care professional. Always ask your health care||
6060|007|Z|professional for complete information about this product and your||
6060|008|Z|specific health needs.||
6060|009|B|||
6060|010|T|PHENOXYBENZAMINE - ORAL||
6060|011|F|(fen-OX-ee-BEN-za-meen)||
6060|012|B|||
6060|013|C|COMMON BRAND NAME(S): Dibenzyline||
6060|014|B|||
6060|015|U|USES:  This medication is used to treat high blood pressure and||
6060|016|U|heavy sweating due to a certain adrenal gland tumor||
6060|017|U|(pheochromocytoma). Phenoxybenzamine belongs to a class of drugs||
6060|018|U|known as alpha blockers. It works by relaxing and widening blood||
6060|019|U|vessels so that blood can flow more easily.||
6060|020|B|||
6060|021|V|OTHER USES:  This section contains uses of this drug that are not||
6060|022|V|listed in the approved professional labeling for the drug but||
6060|023|V|that may be prescribed by your health care professional. Use this||
6060|024|V|drug for a condition that is listed in this section only if it||
6060|025|V|has been so prescribed by your health care professional.||
6060|026|V|   This drug may also be used for certain blood circulation||
6060|027|V|problems (such as Raynaud's syndrome) or for certain conditions||
6060|028|V|which involve difficulty urinating (such as neurogenic bladder,||
6060|029|V|partial prostatic obstruction).||
6060|030|B|||
6060|031|H|HOW TO USE:  Take this medication by mouth with or without food||
6060|032|H|as directed by your doctor, usually 2 to 3 times daily.||
6060|033|H|   The dosage is based on your medical condition and response to||
6060|034|H|treatment.||
6060|035|H|   Use this medication regularly in order to get the most benefit||
6060|036|H|from it. To help you remember, take it at the same times each||
6060|037|H|day. Keep taking this medication even if you feel well. Most||
6060|038|H|people with high blood pressure do not feel sick.||
6060|039|H|   Do not suddenly stop taking this medication without consulting||
6060|040|H|your doctor. Your condition may become worse when the drug is||
6060|041|H|suddenly stopped. Your dose may need to be gradually decreased.||
6060|042|H|   Tell your doctor if your condition does not get better or if||
6060|043|H|it gets worse (for example, your blood pressure readings remain||
6060|044|H|high or increase).||
6060|045|B|||
6060|046|S|SIDE EFFECTS:  Stomach upset, nausea, stuffy nose, drowsiness,||
6060|047|S|dizziness or decrease in pupil size may occur. If any of these||
6060|048|S|effects last or get worse, tell your doctor or pharmacist||
6060|049|S|promptly.||
6060|050|S|   To reduce the risk of dizziness and lightheadedness, get up||
6060|051|S|slowly when rising from a sitting or lying position.||
6060|052|S|   Remember that this medication has been prescribed because your||
6060|053|S|doctor has judged that the benefit to you is greater than the||
6060|054|S|risk of side effects. Many people using this medication do not||
6060|055|S|have serious side effects.||
6060|056|S|   Tell your doctor right away if you have any serious side||
6060|057|S|effects, including: fast heartbeat, fainting, sexual problems in||
6060|058|S|males (such as trouble ejaculating), weakness.||
6060|059|S|   Rarely, males may have a painful or prolonged erection lasting||
6060|060|S|4 or more hours. If this occurs, stop using this drug and get||
6060|061|S|medical help right away, or permanent problems could occur.||
6060|062|S|   A very serious allergic reaction to this drug is rare.||
6060|063|S|However, get medical help right away if you notice any symptoms||
6060|064|S|of a serious allergic reaction, including: rash, itching/swelling||
6060|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6060|066|S|breathing.||
6060|067|S|   This is not a complete list of possible side effects. If you||
6060|068|S|notice other effects not listed above, contact your doctor or||
6060|069|S|pharmacist.||
6060|070|S|   In the US -||
6060|071|S|   Call your doctor for medical advice about side effects. You||
6060|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6060|073|S|www.fda.gov/medwatch.||
6060|074|S|   In Canada - Call your doctor for medical advice about side||
6060|075|S|effects. You may report side effects to Health Canada at||
6060|076|S|1-866-234-2345.||
6060|077|B|||
6060|078|P|PRECAUTIONS:  Before taking phenoxybenzamine, tell your doctor or||
6060|079|P|pharmacist if you are allergic to it; or to other alpha blockers||
6060|080|P|(such as phentolamine); or if you have any other allergies. This||
6060|081|P|product may contain inactive ingredients, which can cause||
6060|082|P|allergic reactions or other problems. Talk to your pharmacist for||
6060|083|P|more details.||
6060|084|P|   Before using this medication, tell your doctor or pharmacist||
6060|085|P|your medical history, especially of: blood vessel disease (such||
6060|086|P|as cerebral arteriosclerosis, coronary artery disease), heart||
6060|087|P|disease (such as heart failure), kidney disease, lung infections,||
6060|088|P|certain eye problems (cataracts, glaucoma).||
6060|089|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6060|090|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6060|091|P|machinery, or do anything that needs alertness until you can do||
6060|092|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
6060|093|P|are using marijuana (cannabis).||
6060|094|P|   Before having surgery (including cataract/glaucoma eye||
6060|095|P|surgery), tell your doctor or dentist if you are taking or have||
6060|096|P|ever taken this medication, and about all the other products you||
6060|097|P|use (including prescription drugs, nonprescription drugs, and||
6060|098|P|herbal products).||
6060|099|P|   Older adults may be more sensitive to the side effects of this||
6060|100|P|drug, especially dizziness. Dizziness can increase the risk of||
6060|101|P|falling.||
6060|102|P|   During pregnancy, this medication should be used only when||
6060|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
6060|104|P|   It is unknown if this drug passes into breast milk. Consult||
6060|105|P|your doctor before breastfeeding.||
6060|106|B|||
6060|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6060|108|I|medications work or increase your risk for serious side effects.||
6060|109|I|This document does not contain all possible drug interactions.||
6060|110|I|Keep a list of all the products you use (including||
6060|111|I|prescription/nonprescription drugs and herbal products) and share||
6060|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
6060|113|I|the dosage of any medicines without your doctor's approval.||
6060|114|I|   Some products that may interact with this drug are: drugs to||
6060|115|I|treat erectile dysfunction-ED or pulmonary hypertension (such as||
6060|116|I|sildenafil, tadalafil), epinephrine, other alpha blockers (such||
6060|117|I|as prazosin), other drugs for high blood pressure (such as||
6060|118|I|diuretics, ACE inhibitors, beta blockers).||
6060|119|I|   Tell your doctor or pharmacist if you are taking other||
6060|120|I|products that cause drowsiness such as opioid pain or cough||
6060|121|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6060|122|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
6060|123|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6060|124|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6060|125|I|diphenhydramine).||
6060|126|I|   Check the labels on all your medicines (such as allergy or||
6060|127|I|cough-and-cold products) because they may contain ingredients||
6060|128|I|that cause drowsiness. Ask your pharmacist about using those||
6060|129|I|products safely.||
6060|130|I|   Some products have ingredients that could raise your blood||
6060|131|I|pressure. Tell your pharmacist what products you are using, and||
6060|132|I|ask how to use them safely (especially cough-and-cold products,||
6060|133|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
6060|134|B|||
6060|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6060|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6060|137|O|poison control center right away. US residents can call||
6060|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6060|139|O|Symptoms of overdose may include: fainting, severe weakness, fast||
6060|140|O|heartbeat.||
6060|141|B|||
6060|142|N|NOTES:  Do not share this medication with others.||
6060|143|N|   Have your blood pressure checked regularly while taking this||
6060|144|N|medication. Learn how to monitor your own blood pressure at home,||
6060|145|N|and share the results with your doctor.||
6060|146|B|||
6060|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6060|148|D|remember. If it is near the time of the next dose, skip the||
6060|149|D|missed dose. Take your next dose at the regular time. Do not||
6060|150|D|double the dose to catch up.||
6060|151|B|||
6060|152|R|STORAGE:  Store at room temperature away from light and moisture.||
6060|153|R|Do not store in the bathroom. Keep all medications away from||
6060|154|R|children and pets.||
6060|155|R|   Do not flush medications down the toilet or pour them into a||
6060|156|R|drain unless instructed to do so. Properly discard this product||
6060|157|R|when it is expired or no longer needed. Consult your pharmacist||
6060|158|R|or local waste disposal company.||
6060|159|B|||
6060|160|A|Information last revised August 2024.||
6060|161|A|Copyright(c) 2025 First Databank, Inc.||
6060|162|B|||
6061|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6061|002|Z|does NOT have all possible information about this product. This||
6061|003|Z|information does not assure that this product is safe, effective,||
6061|004|Z|or appropriate for you. This information is not individual||
6061|005|Z|medical advice and does not substitute for the advice of your||
6061|006|Z|health care professional. Always ask your health care||
6061|007|Z|professional for complete information about this product and your||
6061|008|Z|specific health needs.||
6061|009|B|||
6061|010|T|GLIPIZIDE EXTENDED-RELEASE - ORAL||
6061|011|F|(GLIP-i-zide)||
6061|012|B|||
6061|013|C|COMMON BRAND NAME(S): Glucotrol XL||
6061|014|B|||
6061|015|U|USES:  Glipizide is used with a proper diet and exercise program||
6061|016|U|to control high blood sugar in people with type 2 diabetes. It||
6061|017|U|may also be used with other diabetes medications. Controlling||
6061|018|U|high blood sugar helps prevent kidney damage, blindness, nerve||
6061|019|U|problems, loss of limbs, and sexual function problems. Proper||
6061|020|U|control of diabetes may also lessen your risk of a heart attack||
6061|021|U|or stroke. Glipizide belongs to the class of drugs known as||
6061|022|U|sulfonylureas. It lowers blood sugar by causing the release of||
6061|023|U|your body's natural insulin.||
6061|024|B|||
6061|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6061|026|H|from your pharmacist before you start taking glipizide and each||
6061|027|H|time you get a refill. If you have any questions, ask your doctor||
6061|028|H|or pharmacist.||
6061|029|H|   Take this medication by mouth with breakfast or the first main||
6061|030|H|meal of the day as directed by your doctor, usually once daily.||
6061|031|H|The dosage is based on your medical condition and response to||
6061|032|H|treatment.||
6061|033|H|   To reduce your risk of side effects, your doctor may direct||
6061|034|H|you to start this medication at a low dose and gradually increase||
6061|035|H|your dose. Follow your doctor's instructions carefully.||
6061|036|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
6061|037|H|Doing so can release all of the drug at once, increasing the risk||
6061|038|H|of side effects.||
6061|039|H|   Colesevelam can decrease the absorption of glipizide. If you||
6061|040|H|are taking colesevelam, take glipizide at least 4 hours before||
6061|041|H|taking colesevelam.||
6061|042|H|   Use this medication regularly to get the most benefit from it.||
6061|043|H|To help you remember, take it at the same time each day.||
6061|044|H|   Tell your doctor if your condition does not get better or if||
6061|045|H|it gets worse (your blood sugar is too high or too low).||
6061|046|B|||
6061|047|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, diarrhea,||
6061|048|S|constipation, upset stomach, gas, headache, and weight gain may||
6061|049|S|occur. If any of these effects last or get worse, tell your||
6061|050|S|doctor or pharmacist promptly.||
6061|051|S|   An empty tablet shell may appear in your stool. This effect is||
6061|052|S|harmless because your body has already absorbed the medication.||
6061|053|S|   Remember that this medication has been prescribed because your||
6061|054|S|doctor has judged that the benefit to you is greater than the||
6061|055|S|risk of side effects. Many people using this medication do not||
6061|056|S|have serious side effects.||
6061|057|S|   Tell your doctor right away if you have any serious side||
6061|058|S|effects, including: signs of infection (such as sore throat that||
6061|059|S|doesn't go away, fever, chills), easy bleeding/bruising, signs of||
6061|060|S|liver disease (such as stomach/abdominal pain, yellowing||
6061|061|S|eyes/skin, dark urine), unusual tiredness/weakness,||
6061|062|S|unusual/sudden weight gain, mental/mood changes, swelling||
6061|063|S|hands/feet, seizures.||
6061|064|S|   This medication can cause low blood sugar (hypoglycemia). This||
6061|065|S|may occur if you do not get enough calories from food or if you||
6061|066|S|do unusually heavy exercise. Symptoms of low blood sugar include||
6061|067|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
6061|068|S|dizziness, or tingling hands/feet. It is a good habit to carry||
6061|069|S|glucose tablets or gel to treat low blood sugar. If you don't||
6061|070|S|have these reliable forms of glucose, rapidly raise your blood||
6061|071|S|sugar by eating a quick source of sugar such as table sugar,||
6061|072|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
6061|073|S|doctor right away about the reaction and the use of this product.||
6061|074|S|To help prevent low blood sugar, eat meals on a regular schedule,||
6061|075|S|and do not skip meals. Check with your doctor or pharmacist to||
6061|076|S|find out what you should do if you miss a meal.||
6061|077|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
6061|078|S|thirst/urination. If these symptoms occur, tell your doctor right||
6061|079|S|away. Your doctor may need to adjust your diabetes medication,||
6061|080|S|exercise program, or diet.||
6061|081|S|   A very serious allergic reaction to this drug is rare.||
6061|082|S|However, get medical help right away if you notice any symptoms||
6061|083|S|of a serious allergic reaction, including: rash, itching/swelling||
6061|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6061|085|S|breathing.||
6061|086|S|   This is not a complete list of possible side effects. If you||
6061|087|S|notice other effects not listed above, contact your doctor or||
6061|088|S|pharmacist.||
6061|089|S|   In the US -||
6061|090|S|   Call your doctor for medical advice about side effects. You||
6061|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6061|092|S|www.fda.gov/medwatch.||
6061|093|S|   In Canada - Call your doctor for medical advice about side||
6061|094|S|effects. You may report side effects to Health Canada at||
6061|095|S|1-866-234-2345.||
6061|096|B|||
6061|097|P|PRECAUTIONS:  Before taking glipizide, tell your doctor or||
6061|098|P|pharmacist if you are allergic to it; or if you have any other||
6061|099|P|allergies. This product may contain inactive ingredients, which||
6061|100|P|can cause allergic reactions or other problems. Talk to your||
6061|101|P|pharmacist for more details.||
6061|102|P|   Before using this medication, tell your doctor or pharmacist||
6061|103|P|your medical history, especially of: liver disease, kidney||
6061|104|P|disease, thyroid disease, certain hormonal conditions||
6061|105|P|(adrenal/pituitary insufficiency, syndrome of inappropriate||
6061|106|P|secretion of antidiuretic hormone-SIADH), electrolyte imbalance||
6061|107|P|(hyponatremia), stomach/intestine problems (such as||
6061|108|P|gastrointestinal stenosis or stricture, impaired emptying).||
6061|109|P|   You may experience blurred vision, dizziness, or drowsiness||
6061|110|P|due to extremely low or high blood sugar. Do not drive, use||
6061|111|P|machinery, or do anything that needs alertness or clear vision||
6061|112|P|until you can do it safely.||
6061|113|P|   Limit alcohol while taking this medication because it can||
6061|114|P|increase your risk of developing low blood sugar. Alcohol can||
6061|115|P|rarely interact with glipizide and cause a serious reaction||
6061|116|P|(disulfiram-like reaction) with symptoms such as facial flushing,||
6061|117|P|nausea, vomiting, dizziness, or stomach pain. Consult your doctor||
6061|118|P|or pharmacist about the safe use of alcohol.||
6061|119|P|   It may be harder to control your blood sugar when your body is||
6061|120|P|stressed (such as due to fever, infection, injury, or surgery).||
6061|121|P|Consult your doctor because this may require a change in your||
6061|122|P|treatment plan, medications, or blood sugar testing.||
6061|123|P|   This medication may make you more sensitive to the sun. Limit||
6061|124|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
6061|125|P|sunscreen and wear protective clothing when outdoors. Tell your||
6061|126|P|doctor right away if you get sunburned or have skin||
6061|127|P|blisters/redness.||
6061|128|P|   Before having surgery, tell your doctor or dentist about all||
6061|129|P|the products you use (including prescription drugs,||
6061|130|P|nonprescription drugs, and herbal products).||
6061|131|P|   Older adults may be more sensitive to the side effects of this||
6061|132|P|drug, especially low blood sugar.||
6061|133|P|   During pregnancy, this medication should be used only when||
6061|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
6061|135|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
6061|136|P|your doctor for managing your blood sugar while pregnant. Your||
6061|137|P|doctor may change your diabetes treatment during your pregnancy||
6061|138|P|(such as diet and medications including insulin).||
6061|139|P|   It is unknown if this medication passes into breast milk.||
6061|140|P|However, similar drugs pass into breast milk. Consult your doctor||
6061|141|P|before breastfeeding.||
6061|142|B|||
6061|143|I|DRUG INTERACTIONS:  See also How to Use section.||
6061|144|I|   Drug interactions may change how your medications work or||
6061|145|I|increase your risk for serious side effects. This document does||
6061|146|I|not contain all possible drug interactions. Keep a list of all||
6061|147|I|the products you use (including prescription/nonprescription||
6061|148|I|drugs and herbal products) and share it with your doctor and||
6061|149|I|pharmacist. Do not start, stop, or change the dosage of any||
6061|150|I|medicines without your doctor's approval.||
6061|151|I|   Many drugs can affect your blood sugar, making it harder to||
6061|152|I|control. Before you start, stop, or change any medication, talk||
6061|153|I|with your doctor or pharmacist about how the medication may||
6061|154|I|affect your blood sugar. Check your blood sugar regularly as||
6061|155|I|directed and share the results with your doctor. Tell your doctor||
6061|156|I|right away if you have symptoms of high or low blood sugar. (See||
6061|157|I|also Side Effects section.) Your doctor may need to adjust your||
6061|158|I|diabetes medication, exercise program, or diet.||
6061|159|I|   Beta-blocker medications (including metoprolol, propranolol,||
6061|160|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
6061|161|I|heartbeat you would usually feel when your blood sugar falls too||
6061|162|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
6061|163|I|dizziness, hunger, or sweating are unaffected by these drugs.||
6061|164|B|||
6061|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6061|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6061|167|O|poison control center right away. US residents can call||
6061|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6061|169|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
6061|170|O|sweating, loss of consciousness.||
6061|171|B|||
6061|172|N|NOTES:  Do not share this medication with others.||
6061|173|N|   Attend a diabetes education program to learn more about how to||
6061|174|N|manage your diabetes with medications, diet, exercise, and||
6061|175|N|regular medical exams.||
6061|176|N|   Learn the symptoms of high and low blood sugar and how to||
6061|177|N|treat low blood sugar. Check your blood sugar regularly as||
6061|178|N|directed.||
6061|179|N|   Lab and/or medical tests (such as liver/kidney function,||
6061|180|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
6061|181|N|should be done while you are taking this medication. Keep all||
6061|182|N|medical and lab appointments. Consult your doctor for more||
6061|183|N|details.||
6061|184|B|||
6061|185|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
6061|186|D|you remember. If it is near the time of the next dose, skip the||
6061|187|D|missed dose. Take your next dose at the regular time. Do not||
6061|188|D|double the dose to catch up.||
6061|189|B|||
6061|190|R|STORAGE:  Store at room temperature away from light and moisture.||
6061|191|R|Do not store in the bathroom. Keep all medications away from||
6061|192|R|children and pets.||
6061|193|R|   Do not flush medications down the toilet or pour them into a||
6061|194|R|drain unless instructed to do so. Properly discard this product||
6061|195|R|when it is expired or no longer needed. Consult your pharmacist||
6061|196|R|or local waste disposal company.||
6061|197|B|||
6061|198|M|MEDICAL ALERT:  Your condition can cause complications in a||
6061|199|M|medical emergency. For information about enrolling in MedicAlert,||
6061|200|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6061|201|B|||
6061|202|A|Information last revised November 2025.||
6061|203|A|Copyright(c) 2025 First Databank, Inc.||
6061|204|B|||
6069|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6069|002|Z|does NOT have all possible information about this product. This||
6069|003|Z|information does not assure that this product is safe, effective,||
6069|004|Z|or appropriate for you. This information is not individual||
6069|005|Z|medical advice and does not substitute for the advice of your||
6069|006|Z|health care professional. Always ask your health care||
6069|007|Z|professional for complete information about this product and your||
6069|008|Z|specific health needs.||
6069|009|B|||
6069|010|T|RIBAVIRIN - INHALATION||
6069|011|F|(RYE-ba-VYE-rin)||
6069|012|B|||
6069|013|C|COMMON BRAND NAME(S): Virazole||
6069|014|B|||
6069|015|W|WARNING:  Caution is advised when using this medication in people||
6069|016|W|who are using a certain breathing device (ventilator). Read and||
6069|017|W|follow the manufacturer's directions for use and care of the||
6069|018|W|ventilator. Follow all directions from the manufacturer to||
6069|019|W|prevent particle buildup in the device. Doing so will help the||
6069|020|W|device work properly and may prevent serious side effects (such||
6069|021|W|as air pressure buildup inside the lungs).||
6069|022|W|   Rarely, sudden worsening of breathing problems may occur,||
6069|023|W|especially when this medication is first started. If this occurs,||
6069|024|W|treatment should be stopped. If you and the doctor decide to||
6069|025|W|restart ribavirin treatment, the doctor will monitor closely to||
6069|026|W|decrease the risk of side effects.||
6069|027|B|||
6069|028|U|USES:  This medication is an anti-viral drug used to treat||
6069|029|U|infants and young children who have a severe lung infection||
6069|030|U|caused by a certain virus (respiratory syncytial virus-RSV).||
6069|031|U|Nearly all children become infected with this virus before they||
6069|032|U|are 3 years old. Most cases are mild and do not require||
6069|033|U|anti-viral drugs. This medication is used to treat severe RSV||
6069|034|U|infections that need treatment in a hospital.||
6069|035|U|   Ribavirin for inhalation is not recommended for use in adults.||
6069|036|B|||
6069|037|H|HOW TO USE:  This medication is given by a health care||
6069|038|H|professional. It is given by continuous inhalation as directed by||
6069|039|H|the doctor, usually for 12 to18 hours a day for 3 to 7 days. A||
6069|040|H|special machine (small-particle aerosol generator) is used to||
6069|041|H|make a mist, which is then inhaled through the mouth or nose.||
6069|042|H|   Health care workers providing care to patients receiving this||
6069|043|H|medication should learn all precautions for handling/giving this||
6069|044|H|medication (such as wearing a mask, room ventilation). The||
6069|045|H|manufacturer recommends that health care workers who are pregnant||
6069|046|H|should consider avoiding direct care of patients using this||
6069|047|H|medication. This medication must not be used during pregnancy||
6069|048|H|since it may harm an unborn baby. Consult the manufacturer's||
6069|049|H|package or the hospital/occupational safety guidelines for||
6069|050|H|details.||
6069|051|B|||
6069|052|S|SIDE EFFECTS:  Chest soreness may occur. Redness/irritation of||
6069|053|S|the eye or eyelid may also occur. If any of these effects last or||
6069|054|S|get worse, tell the doctor or pharmacist promptly.||
6069|055|S|   Remember that this medication has been prescribed because the||
6069|056|S|doctor has judged that the benefit to your child is greater than||
6069|057|S|the risk of side effects. Many people using this medication do||
6069|058|S|not have serious side effects.||
6069|059|S|   Tell the doctor right away if your child has any serious side||
6069|060|S|effects, including: pale/bluish skin around the||
6069|061|S|mouth/lips/fingernails, worsening of breathing trouble,||
6069|062|S|slow/fast/irregular heartbeat.||
6069|063|S|   Get medical help right away if your child has any very serious||
6069|064|S|side effects, including: fainting, seizure.||
6069|065|S|   This medication may rarely cause anemia, usually within 1 to 2||
6069|066|S|weeks after treatment is started. Tell the doctor right away if||
6069|067|S|you notice any symptoms of anemia such as unusual tiredness or||
6069|068|S|fast/pounding heartbeat.||
6069|069|S|   A very serious allergic reaction to this drug is rare.||
6069|070|S|However, get medical help right away if you notice any symptoms||
6069|071|S|of a serious allergic reaction, including: rash, itching/swelling||
6069|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6069|073|S|breathing.||
6069|074|S|   This is not a complete list of possible side effects. If you||
6069|075|S|notice other effects not listed above, contact the doctor or||
6069|076|S|pharmacist.||
6069|077|S|   In the US -||
6069|078|S|   Call your doctor for medical advice about side effects. You||
6069|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6069|080|S|www.fda.gov/medwatch.||
6069|081|S|   In Canada - Call your doctor for medical advice about side||
6069|082|S|effects. You may report side effects to Health Canada at||
6069|083|S|1-866-234-2345.||
6069|084|B|||
6069|085|P|PRECAUTIONS:  Before your child receives ribavirin for||
6069|086|P|inhalation, tell the doctor or pharmacist if your child is||
6069|087|P|allergic to it; or if your child has any other allergies. This||
6069|088|P|product may contain inactive ingredients, which can cause||
6069|089|P|allergic reactions or other problems. Talk to your pharmacist for||
6069|090|P|more details.||
6069|091|P|   Before using this medication, tell the doctor or pharmacist||
6069|092|P|your child's medical history, especially of: breathing disorders||
6069|093|P|(such as asthma).||
6069|094|P|   Before having surgery, tell the doctor or dentist about all||
6069|095|P|the products your child uses (including prescription drugs,||
6069|096|P|nonprescription drugs, and herbal products).||
6069|097|P|   This product is not usually used by adults. It is unlikely to||
6069|098|P|be used during pregnancy or breastfeeding. Consult your doctor if||
6069|099|P|you have any questions about this product. (See also health care||
6069|100|P|worker information in How to Use section.)||
6069|101|B|||
6069|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6069|103|I|medications work or increase your risk for serious side effects.||
6069|104|I|This document does not contain all possible drug interactions.||
6069|105|I|Keep a list of all the products you use (including||
6069|106|I|prescription/nonprescription drugs and herbal products) and share||
6069|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
6069|108|I|the dosage of any medicines without your doctor's approval.||
6069|109|I|   Some products that may interact with this drug are: certain||
6069|110|I|HIV drugs (didanosine, stavudine, zidovudine).||
6069|111|B|||
6069|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6069|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6069|114|O|poison control center right away. US residents can call||
6069|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6069|116|B|||
6069|117|N|NOTES:  Lab and/or medical tests (such as lung function, blood||
6069|118|N|counts) should be done while your child is using this medication.||
6069|119|N|Keep all medical and lab appointments. Consult your doctor for||
6069|120|N|more details.||
6069|121|B|||
6069|122|D|MISSED DOSE:  If a dose is interrupted or stopped, ask your||
6069|123|D|doctor or pharmacist right away for a new dosing schedule.||
6069|124|B|||
6069|125|R|STORAGE:  Not applicable. This medication is given in a hospital||
6069|126|R|and will not be stored at home.||
6069|127|B|||
6069|128|A|Information last revised May 2024.||
6069|129|A|Copyright(c) 2025 First Databank, Inc.||
6069|130|B|||
6071|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6071|002|Z|does NOT have all possible information about this product. This||
6071|003|Z|information does not assure that this product is safe, effective,||
6071|004|Z|or appropriate for you. This information is not individual||
6071|005|Z|medical advice and does not substitute for the advice of your||
6071|006|Z|health care professional. Always ask your health care||
6071|007|Z|professional for complete information about this product and your||
6071|008|Z|specific health needs.||
6071|009|B|||
6071|010|T|SULFAMETHOXAZOLE/TRIMETHOPRIM - INJECTION||
6071|011|F|(SUL-fa-meth-OX-a-zole/trye-METH-oh-prim)||
6071|012|B|||
6071|013|C|COMMON BRAND NAME(S): Bactrim, Septra||
6071|014|B|||
6071|015|U|USES:  This medication is used to treat a wide variety of||
6071|016|U|bacterial infections. It is also used to treat a certain type of||
6071|017|U|pneumonia (pneumocystis pneumonia) in patients with a weakened||
6071|018|U|immune system. This medication is a combination of 2 antibiotics:||
6071|019|U|sulfamethoxazole and trimethoprim. It works by stopping the||
6071|020|U|growth of bacteria and the pneumocystis fungus.||
6071|021|U|   This medication should not be used by children less than 2||
6071|022|U|months of age due to the risk of serious side effects.||
6071|023|B|||
6071|024|H|HOW TO USE:  This medication is given by injection into a vein as||
6071|025|H|directed by your doctor. It is given by slow infusion over 60 to||
6071|026|H|90 minutes. The dosage is based on your medical condition,||
6071|027|H|weight, and response to treatment.||
6071|028|H|   If you are giving this medication to yourself at home, learn||
6071|029|H|all preparation and usage instructions from your health care||
6071|030|H|professional. Before using, check this product for particles or||
6071|031|H|discoloration. If either is present, do not use the liquid. Learn||
6071|032|H|how to store and discard medical supplies safely.||
6071|033|H|   Drink plenty of fluids while taking this medication to lower||
6071|034|H|the unlikely risk of kidney stones forming, unless your doctor||
6071|035|H|advises you otherwise.||
6071|036|H|   For the best effect, use this antibiotic at evenly spaced||
6071|037|H|times. To help you remember, use this medication at the same||
6071|038|H|time(s) every day.||
6071|039|H|   Continue to use this medication for the full time prescribed,||
6071|040|H|even if symptoms disappear after a few days. Stopping the||
6071|041|H|medication too early may result in a return of the infection.||
6071|042|H|   Tell your doctor if your condition lasts or gets worse.||
6071|043|B|||
6071|044|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, loss of appetite, and||
6071|045|S|pain/redness/swelling at the injection site may occur. If any of||
6071|046|S|these effects last or get worse, tell your doctor or pharmacist||
6071|047|S|promptly.||
6071|048|S|   Remember that this medication has been prescribed because your||
6071|049|S|doctor has judged that the benefit to you is greater than the||
6071|050|S|risk of side effects. Many people using this medication do not||
6071|051|S|have serious side effects.||
6071|052|S|   Tell your doctor right away if you have any serious side||
6071|053|S|effects, including: muscle weakness, mental/mood changes, signs||
6071|054|S|of kidney problems (such as change in the amount of urine, blood||
6071|055|S|in the urine), extreme drowsiness, signs of low blood sugar (such||
6071|056|S|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
6071|057|S|vision, dizziness, or tingling hands/feet).||
6071|058|S|   Get medical help right away if you have any very serious side||
6071|059|S|effects, including: headache that doesn't go away, neck||
6071|060|S|stiffness, seizures, slow/irregular heartbeat.||
6071|061|S|   This medication may rarely cause a severe intestinal condition||
6071|062|S|due to a bacteria called C. difficile. This condition may occur||
6071|063|S|during treatment or weeks to months after treatment has stopped.||
6071|064|S|Tell your doctor right away if you develop: diarrhea that doesn't||
6071|065|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
6071|066|S|stool.||
6071|067|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
6071|068|S|products because they may make symptoms worse.||
6071|069|S|   Use of this medication for prolonged or repeated periods may||
6071|070|S|result in oral thrush or a new yeast infection. Contact your||
6071|071|S|doctor if you notice white patches in your mouth, a change in||
6071|072|S|vaginal discharge, or other new symptoms.||
6071|073|S|   This medication may rarely cause serious (possibly fatal)||
6071|074|S|allergic reactions and other side effects such as a severe||
6071|075|S|peeling skin rash (such as Stevens-Johnson syndrome), blood||
6071|076|S|disorders (such as agranulocytosis, aplastic anemia), liver||
6071|077|S|damage, or lung injury. If you notice any of the following, get||
6071|078|S|medical help right away: sore throat or fever that doesn't go||
6071|079|S|away, cough that doesn't go away, nausea/vomiting that doesn't||
6071|080|S|stop, skin rash/blisters, itching/swelling (especially of the||
6071|081|S|face/tongue/throat), new or worsening lymph node swelling, severe||
6071|082|S|dizziness, paleness, chest pain, joint pain/aches, trouble||
6071|083|S|breathing, easy bleeding/bruising, yellowing eyes/skin, unusual||
6071|084|S|tiredness, dark urine.||
6071|085|S|   This is not a complete list of possible side effects. If you||
6071|086|S|notice other effects not listed above, contact your doctor or||
6071|087|S|pharmacist.||
6071|088|S|   In the US -||
6071|089|S|   Call your doctor for medical advice about side effects. You||
6071|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6071|091|S|www.fda.gov/medwatch.||
6071|092|S|   In Canada - Call your doctor for medical advice about side||
6071|093|S|effects. You may report side effects to Health Canada at||
6071|094|S|1-866-234-2345.||
6071|095|B|||
6071|096|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6071|097|P|pharmacist if you are allergic to sulfamethoxazole or||
6071|098|P|trimethoprim; or to sulfa medications; or if you have any other||
6071|099|P|allergies. This product may contain inactive ingredients (such as||
6071|100|P|benzyl alcohol or propylene glycol found in some brands), which||
6071|101|P|can cause allergic reactions or other problems. Talk to your||
6071|102|P|pharmacist for more details.||
6071|103|P|   Before using this medication, tell your doctor or pharmacist||
6071|104|P|your medical history, especially of: kidney disease, liver||
6071|105|P|disease, certain blood disorders (such as porphyria, anemia due||
6071|106|P|to folate vitamin deficiency), history of blood disorders caused||
6071|107|P|by trimethoprim or sulfa medications, vitamin deficiency (folate||
6071|108|P|or folic acid), severe allergies, asthma, decreased bone marrow||
6071|109|P|function (bone marrow suppression), a certain metabolic disorder||
6071|110|P|(G6PD deficiency), underactive thyroid, mineral imbalances (such||
6071|111|P|as high level of potassium or low level of sodium in the blood).||
6071|112|P|   This medication may cause live bacterial vaccines (such as||
6071|113|P|typhoid vaccine) to not work well. Tell your health care||
6071|114|P|professional that you are using this medication before having any||
6071|115|P|immunizations/vaccinations.||
6071|116|P|   Before having surgery, tell your doctor or dentist about all||
6071|117|P|the products you use (including prescription drugs,||
6071|118|P|nonprescription drugs, and herbal products).||
6071|119|P|   This medication may make you more sensitive to the sun. Limit||
6071|120|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
6071|121|P|sunscreen and wear protective clothing when outdoors. Get medical||
6071|122|P|help right away if you get sunburned or have skin||
6071|123|P|blisters/redness.||
6071|124|P|   If you have diabetes, this product may affect your blood||
6071|125|P|sugar. Check your blood sugar regularly as directed and share the||
6071|126|P|results with your doctor. Tell your doctor right away if you have||
6071|127|P|symptoms of low blood sugar (see Side Effects section). Your||
6071|128|P|doctor may need to adjust your diabetes medication, exercise||
6071|129|P|program, or diet.||
6071|130|P|   Older adults may be more sensitive to the side effects of this||
6071|131|P|drug, especially skin reactions, blood disorders, easy||
6071|132|P|bleeding/bruising, and a high potassium blood level.||
6071|133|P|   Patients with AIDS may be more sensitive to the side effects||
6071|134|P|of this drug, especially skin reactions, fever, and blood||
6071|135|P|disorders.||
6071|136|P|   Tell your doctor if you are pregnant or plan to become||
6071|137|P|pregnant. You should not become pregnant while using||
6071|138|P|sulfamethoxazole/trimethoprim. This medication may harm an unborn||
6071|139|P|baby. If you become pregnant, talk to your doctor right away||
6071|140|P|about the risks and benefits of this medication.||
6071|141|P|   This drug passes into breast milk. This drug may have||
6071|142|P|undesirable effects on infants who are ill or premature or have||
6071|143|P|certain disorders (jaundice, high blood levels of bilirubin, G6PD||
6071|144|P|deficiency). Breastfeeding is not recommended for infants with||
6071|145|P|these conditions. Consult your doctor before breastfeeding.||
6071|146|B|||
6071|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6071|148|I|medications work or increase your risk for serious side effects.||
6071|149|I|This document does not contain all possible drug interactions.||
6071|150|I|Keep a list of all the products you use (including||
6071|151|I|prescription/nonprescription drugs and herbal products) and share||
6071|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
6071|153|I|the dosage of any medicines without your doctor's approval.||
6071|154|I|   Some products that may interact with this drug include: "blood||
6071|155|I|thinners" (such as warfarin), dofetilide, methenamine,||
6071|156|I|methotrexate.||
6071|157|I|   This medication may interfere with certain lab tests, possibly||
6071|158|I|causing false test results. Make sure lab personnel and all your||
6071|159|I|doctors know you use this drug.||
6071|160|B|||
6071|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6071|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6071|163|O|poison control center right away. US residents can call||
6071|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6071|165|O|Symptoms of overdose may include: severe||
6071|166|O|nausea/vomiting/diarrhea, severe dizziness or drowsiness,||
6071|167|O|mental/mood changes.||
6071|168|B|||
6071|169|N|NOTES:  If you are using this drug for a long time, lab and/or||
6071|170|N|medical tests (such as complete blood count, kidney function,||
6071|171|N|potassium blood level, cultures) should be done while you are||
6071|172|N|using this medication. Keep all medical and lab appointments.||
6071|173|N|Consult your doctor for more details.||
6071|174|B|||
6071|175|D|MISSED DOSE:  It is important to get each dose of this medication||
6071|176|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6071|177|D|right away for a new dosing schedule. Do not double the dose to||
6071|178|D|catch up.||
6071|179|B|||
6071|180|R|STORAGE:  Consult the product instructions and your pharmacist||
6071|181|R|for storage details. Keep all medications away from children and||
6071|182|R|pets.||
6071|183|R|   Do not flush medications down the toilet or pour them into a||
6071|184|R|drain unless instructed to do so. Properly discard this product||
6071|185|R|when it is expired or no longer needed. Consult your pharmacist||
6071|186|R|or local waste disposal company.||
6071|187|B|||
6071|188|A|Information last revised May 2025.||
6071|189|A|Copyright(c) 2025 First Databank, Inc.||
6071|190|B|||
6072|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6072|002|Z|does NOT have all possible information about this product. This||
6072|003|Z|information does not assure that this product is safe, effective,||
6072|004|Z|or appropriate for you. This information is not individual||
6072|005|Z|medical advice and does not substitute for the advice of your||
6072|006|Z|health care professional. Always ask your health care||
6072|007|Z|professional for complete information about this product and your||
6072|008|Z|specific health needs.||
6072|009|B|||
6072|010|T|NEOMYCIN/POLYMYXIN/DEXAMETHASONE OINTMENT - OPHTHALMIC||
6072|011|F|(NEE-oh-MYE-sin/POL-ee-MIX-in/DEX-a-METH-a-sone)||
6072|012|B|||
6072|013|C|COMMON BRAND NAME(S): Maxitrol||
6072|014|B|||
6072|015|U|USES:  This medication is used to treat conditions involving||
6072|016|U|swelling (inflammation) of the eyes and to treat or prevent||
6072|017|U|bacterial eye infections. This product contains neomycin and||
6072|018|U|polymyxin, antibiotics that work by stopping the growth of||
6072|019|U|bacteria. It also contains dexamethasone, an anti-inflammatory||
6072|020|U|corticosteroid that works by reducing swelling.||
6072|021|U|   This medication treats/prevents only bacterial eye infections.||
6072|022|U|It will not work for other types of eye infections and may worsen||
6072|023|U|them (such as infections caused by viruses, fungi, mycobacteria).||
6072|024|U|Unnecessary use or overuse of any antibiotic can lead to its||
6072|025|U|decreased effectiveness.||
6072|026|B|||
6072|027|H|HOW TO USE:  Use this medication in the affected eye(s) as||
6072|028|H|directed by your doctor, usually 3 or 4 times a day.||
6072|029|H|   Do not wear contact lenses while you are using this medicine.||
6072|030|H|Sterilize contact lenses according to manufacturer's directions,||
6072|031|H|and check with your doctor before you begin using them again.||
6072|032|H|   To apply the eye ointment, wash your hands first. To avoid||
6072|033|H|contamination, do not touch the tube tip or let it touch your eye||
6072|034|H|or any other surface. Tilt your head back, look upward, and pull||
6072|035|H|down the lower eyelid to make a pouch. Place a 1/2 inch (1.5||
6072|036|H|centimeters) strip of ointment into the pouch by squeezing the||
6072|037|H|tube gently. Close the eye and roll the eyeball in all directions||
6072|038|H|to spread the medication. Try not to blink and do not rub the||
6072|039|H|eye. Repeat these steps for your other eye if so directed. Wipe||
6072|040|H|the tip of the ointment tube with a clean tissue to remove extra||
6072|041|H|medication before recapping it. Apply as often as directed by||
6072|042|H|your doctor.||
6072|043|H|   If you are using another kind of eye medication (such as drops||
6072|044|H|or ointments), apply the eye drops first and wait at least 5||
6072|045|H|minutes before applying this eye ointment. Use eye drops before||
6072|046|H|eye ointments to allow the eye drops to enter the eye. If you are||
6072|047|H|using another type of eye ointment, wait at least 10 minutes||
6072|048|H|after using this medication before applying it.||
6072|049|H|   Do not use this medication more often than prescribed or for||
6072|050|H|longer than 10 days unless directed by your doctor.||
6072|051|H|   Wait several minutes for your vision to clear before driving||
6072|052|H|or operating machinery.||
6072|053|H|   Use this medication regularly in order to get the most benefit||
6072|054|H|from it. To help you remember, use it at the same times each day.||
6072|055|H|Continue to use this medication for the full time prescribed,||
6072|056|H|even if symptoms disappear after a few days. Stopping the||
6072|057|H|medication too early may result in a return of the infection.||
6072|058|H|   Tell your doctor if your condition does not get better in a||
6072|059|H|few days.||
6072|060|B|||
6072|061|S|SIDE EFFECTS:  Stinging/burning of the eyes for 1 to 2 minutes or||
6072|062|S|temporary blurred vision may occur when this medication is||
6072|063|S|applied. If any of these effects last or get worse, tell your||
6072|064|S|doctor or pharmacist promptly.||
6072|065|S|   Remember that this medication has been prescribed because your||
6072|066|S|doctor has judged that the benefit to you is greater than the||
6072|067|S|risk of side effects. Many people using this medication do not||
6072|068|S|have serious side effects.||
6072|069|S|   Use of this medication for prolonged/repeated periods may||
6072|070|S|result in a new fungal eye infection and may increase your risk||
6072|071|S|for other eye problems (such as glaucoma, cataracts, delayed||
6072|072|S|wound healing). Do not use this medication for longer than||
6072|073|S|prescribed. Tell your doctor right away if any of these unlikely||
6072|074|S|but serious side effects occur: new or worsening eye symptoms||
6072|075|S|(such as discharge, swelling, redness), vision problems, eye||
6072|076|S|pain.||
6072|077|S|   A very serious allergic reaction to this drug is rare.||
6072|078|S|However, get medical help right away if you notice any symptoms||
6072|079|S|of a serious allergic reaction, including: rash, itching/swelling||
6072|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6072|081|S|breathing.||
6072|082|S|   This is not a complete list of possible side effects. If you||
6072|083|S|notice other effects not listed above, contact your doctor or||
6072|084|S|pharmacist.||
6072|085|S|   In the US -||
6072|086|S|   Call your doctor for medical advice about side effects. You||
6072|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6072|088|S|www.fda.gov/medwatch.||
6072|089|S|   In Canada - Call your doctor for medical advice about side||
6072|090|S|effects. You may report side effects to Health Canada at||
6072|091|S|1-866-234-2345.||
6072|092|B|||
6072|093|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6072|094|P|pharmacist if you are allergic to neomycin, polymyxin, or||
6072|095|P|dexamethasone; or to aminoglycoside antibiotics (such as||
6072|096|P|gentamicin, tobramycin); or to corticosteroids (such as||
6072|097|P|hydrocortisone, prednisone); or if you have any other allergies.||
6072|098|P|This product may contain inactive ingredients, which can cause||
6072|099|P|allergic reactions or other problems. Talk to your pharmacist for||
6072|100|P|more details.||
6072|101|P|   Before using this medication, tell your doctor or pharmacist||
6072|102|P|your medical history, especially of: other eye problems (such as||
6072|103|P|glaucoma).||
6072|104|P|   After you apply this drug, your vision may become temporarily||
6072|105|P|blurred. Do not drive, use machinery, or do anything that needs||
6072|106|P|clear vision until you can do it safely.||
6072|107|P|   During pregnancy, this medication should be used only when||
6072|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
6072|109|P|   It is unknown if this drug passes into breast milk. Consult||
6072|110|P|your doctor before breastfeeding.||
6072|111|B|||
6072|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6072|113|I|medications work or increase your risk for serious side effects.||
6072|114|I|This document does not contain all possible drug interactions.||
6072|115|I|Keep a list of all the products you use (including||
6072|116|I|prescription/nonprescription drugs and herbal products) and share||
6072|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
6072|118|I|the dosage of any medicines without your doctor's approval.||
6072|119|B|||
6072|120|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6072|121|O|has overdosed and has serious symptoms such as passing out or||
6072|122|O|trouble breathing, call 911. Otherwise, call a poison control||
6072|123|O|center right away. US residents can call 1-800-222-1222. Canada||
6072|124|O|residents can call 1-844-764-7669.||
6072|125|B|||
6072|126|N|NOTES:  Do not share this medication with others.||
6072|127|N|   This medication has been prescribed for your current condition||
6072|128|N|only. Throw away the unused medication after treatment is||
6072|129|N|completed. Do not use it later for another infection unless your||
6072|130|N|doctor tells you to.||
6072|131|N|   If you use this medication for 10 days or longer, lab and/or||
6072|132|N|medical tests (such as eye exams) should be done while you are||
6072|133|N|using this medication. Keep all medical and lab appointments.||
6072|134|N|Consult your doctor for more details.||
6072|135|B|||
6072|136|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6072|137|D|If it is near the time of the next dose, skip the missed dose.||
6072|138|D|Use your next dose at the regular time. Do not double the dose to||
6072|139|D|catch up.||
6072|140|B|||
6072|141|R|STORAGE:  Store at room temperature away from heat. Keep all||
6072|142|R|medications away from children and pets.||
6072|143|R|   Do not flush medications down the toilet or pour them into a||
6072|144|R|drain unless instructed to do so. Properly discard this product||
6072|145|R|when it is expired or no longer needed. Consult your pharmacist||
6072|146|R|or local waste disposal company.||
6072|147|B|||
6072|148|A|Information last revised November 2024.||
6072|149|A|Copyright(c) 2025 First Databank, Inc.||
6072|150|B|||
6075|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6075|002|Z|does NOT have all possible information about this product. This||
6075|003|Z|information does not assure that this product is safe, effective,||
6075|004|Z|or appropriate for you. This information is not individual||
6075|005|Z|medical advice and does not substitute for the advice of your||
6075|006|Z|health care professional. Always ask your health care||
6075|007|Z|professional for complete information about this product and your||
6075|008|Z|specific health needs.||
6075|009|B|||
6075|010|T|CAPTOPRIL/HYDROCHLOROTHIAZIDE - ORAL||
6075|011|F|(KAP-toe-pril/HYE-droe-KLOR-oh-THYE-a-zide)||
6075|012|B|||
6075|013|C|COMMON BRAND NAME(S): Capozide||
6075|014|B|||
6075|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
6075|016|W|unborn baby if used during pregnancy. It is important to prevent||
6075|017|W|pregnancy while taking this medication. Consult your doctor for||
6075|018|W|more details and to discuss the use of reliable forms of birth||
6075|019|W|control while taking this medication. If you are planning||
6075|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
6075|021|W|your doctor right away.||
6075|022|B|||
6075|023|U|USES:  This medication is used to treat high blood pressure||
6075|024|U|(hypertension). Lowering high blood pressure helps prevent||
6075|025|U|strokes, heart attacks, and kidney problems.||
6075|026|U|   This product contains two medications, captopril and||
6075|027|U|hydrochlorothiazide. Captopril belongs to a class of drugs known||
6075|028|U|as ACE inhibitors. It works by relaxing blood vessels so blood||
6075|029|U|can flow more easily. Hydrochlorothiazide is a "water pill"||
6075|030|U|(diuretic). This drug increases the amount of urine you make,||
6075|031|U|causing your body to get rid of extra salt and water.||
6075|032|B|||
6075|033|V|OTHER USES:  This section contains uses of this drug that are not||
6075|034|V|listed in the approved professional labeling for the drug but||
6075|035|V|that may be prescribed by your health care professional. Use this||
6075|036|V|drug for a condition that is listed in this section only if it||
6075|037|V|has been so prescribed by your health care professional.||
6075|038|V|   This drug may also be used for heart failure.||
6075|039|B|||
6075|040|H|HOW TO USE:  Take this medication by mouth on an empty stomach||
6075|041|H|(one hour before a meal) as directed by your doctor, usually once||
6075|042|H|daily. It is best to avoid taking this medication within 4 hours||
6075|043|H|of your bedtime to avoid having to get up to urinate. Consult||
6075|044|H|your doctor or pharmacist if you have questions about your dosing||
6075|045|H|schedule.||
6075|046|H|   The dosage is based on your medical condition and response to||
6075|047|H|treatment.||
6075|048|H|   If you are also taking cholestyramine or colestipol, take||
6075|049|H|captopril/hydrochlorothiazide at least 4 hours before or at least||
6075|050|H|4 to 6 hours after either of those drugs.||
6075|051|H|   Use this medication regularly in order to get the most benefit||
6075|052|H|from it. To help you remember, take it at the same time each day.||
6075|053|H|Do not skip doses or stop taking this medication unless directed||
6075|054|H|by your doctor. Keep taking this medication even if you feel||
6075|055|H|well. Most people with high blood pressure do not feel sick. It||
6075|056|H|may take up to 6 to 8 weeks before the full benefit of this drug||
6075|057|H|takes effect.||
6075|058|H|   Tell your doctor if your condition does not get better or if||
6075|059|H|it gets worse (your blood pressure readings remain high or||
6075|060|H|increase).||
6075|061|B|||
6075|062|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, or loss of||
6075|063|S|taste may occur as your body adjusts to the medication. Dry cough||
6075|064|S|may also occur. If any of these effects last or get worse, tell||
6075|065|S|your doctor or pharmacist promptly.||
6075|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
6075|067|S|slowly when rising from a sitting or lying position.||
6075|068|S|   Remember that this medication has been prescribed because your||
6075|069|S|doctor has judged that the benefit to you is greater than the||
6075|070|S|risk of side effects. Many people using this medication do not||
6075|071|S|have serious side effects.||
6075|072|S|   This product may cause dehydration and electrolyte imbalance.||
6075|073|S|Tell your doctor right away if you have any symptoms of||
6075|074|S|dehydration or electrolyte imbalance, including unusual dry||
6075|075|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
6075|076|S|heartbeat, or confusion.||
6075|077|S|   Tell your doctor right away if you have any serious side||
6075|078|S|effects, including: signs of infection (such as sore throat that||
6075|079|S|doesn't go away, fever, chills), fainting, easy||
6075|080|S|bruising/bleeding, numbness/tingling/swelling of the hands/feet,||
6075|081|S|muscle/joint aches, decrease in vision, eye pain, signs of kidney||
6075|082|S|problems (such as change in the amount of urine).||
6075|083|S|   This drug may rarely cause serious (possibly fatal) liver||
6075|084|S|problems. Get medical help right away if you have any symptoms of||
6075|085|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
6075|086|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
6075|087|S|urine.||
6075|088|S|   A very serious allergic reaction to this drug is rare.||
6075|089|S|However, get medical help right away if you notice any symptoms||
6075|090|S|of a serious allergic reaction, including: rash, itching/swelling||
6075|091|S|(especially of the face/tongue/throat/arms/legs), severe||
6075|092|S|dizziness, trouble breathing.||
6075|093|S|   This is not a complete list of possible side effects. If you||
6075|094|S|notice other effects not listed above, contact your doctor or||
6075|095|S|pharmacist.||
6075|096|S|   In the US -||
6075|097|S|   Call your doctor for medical advice about side effects. You||
6075|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6075|099|S|www.fda.gov/medwatch.||
6075|100|S|   In Canada - Call your doctor for medical advice about side||
6075|101|S|effects. You may report side effects to Health Canada at||
6075|102|S|1-866-234-2345.||
6075|103|B|||
6075|104|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
6075|105|P|pharmacist if you are allergic to either captopril or||
6075|106|P|hydrochlorothiazide; or to other ACE inhibitors (such as||
6075|107|P|enalapril, lisinopril); or to other thiazides (such as||
6075|108|P|chlorothiazide); or if you have any other allergies (including an||
6075|109|P|allergic reaction after exposure to certain membranes used for||
6075|110|P|blood filtering). This product may contain inactive ingredients,||
6075|111|P|which can cause allergic reactions or other problems. Talk to||
6075|112|P|your pharmacist for more details.||
6075|113|P|   Before using this medication, tell your doctor or pharmacist||
6075|114|P|your medical history, especially of: a history of an allergic||
6075|115|P|reaction that included swelling of the face/lips/tongue/throat||
6075|116|P|(angioedema), kidney problems, liver disease, gout, untreated||
6075|117|P|salt/mineral imbalance (such as imbalance of sodium, potassium,||
6075|118|P|magnesium, calcium), dehydration, collagen vascular disease (such||
6075|119|P|as lupus, scleroderma), recent nerve surgery (such as||
6075|120|P|sympathectomy), skin cancer.||
6075|121|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6075|122|P|can make you more dizzy. Do not drive, use machinery, or do||
6075|123|P|anything that needs alertness until you can do it safely. Limit||
6075|124|P|alcoholic beverages. Talk to your doctor if you are using||
6075|125|P|marijuana (cannabis).||
6075|126|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
6075|127|P|and cause you to feel lightheaded. Tell your doctor if you have||
6075|128|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
6075|129|P|of fluids unless your doctor tells you not to.||
6075|130|P|   This product may affect your potassium levels. Before using||
6075|131|P|potassium supplements or salt substitutes that contain potassium,||
6075|132|P|consult your doctor or pharmacist.||
6075|133|P|   Before having surgery, tell your doctor or dentist about all||
6075|134|P|the products you use (including prescription drugs,||
6075|135|P|nonprescription drugs, and herbal products).||
6075|136|P|   This medication may make you more sensitive to the sun. It may||
6075|137|P|also increase your risk for skin cancer, especially if you take||
6075|138|P|it for a long time. Limit your time in the sun. Avoid tanning||
6075|139|P|booths and sunlamps. Use sunscreen and wear protective clothing||
6075|140|P|when outdoors. Tell your doctor right away if you get sunburned,||
6075|141|P|have skin blisters/redness, or notice new or changed moles/skin||
6075|142|P|lesions.||
6075|143|P|   If you have diabetes, hydrochlorothiazide may affect your||
6075|144|P|blood sugar. Check your blood sugar regularly as directed and||
6075|145|P|share the results with your doctor. Tell your doctor right away||
6075|146|P|if you have symptoms of high blood sugar such as increased||
6075|147|P|thirst/urination. Your doctor may need to adjust your diabetes||
6075|148|P|medication, exercise program, or diet.||
6075|149|P|   Older adults may be more sensitive to the side effects of this||
6075|150|P|drug, especially dizziness and change in the amount of urine||
6075|151|P|(kidney problems).||
6075|152|P|   Tell your doctor if you are pregnant or plan to become||
6075|153|P|pregnant. You should not become pregnant while using this||
6075|154|P|medication. Captopril may harm an unborn baby. If you become||
6075|155|P|pregnant, talk to your doctor right away about the risks and||
6075|156|P|benefits of this medication. (See also Warning section.)||
6075|157|P|   This medication passes into breast milk. Consult your doctor||
6075|158|P|before breastfeeding.||
6075|159|B|||
6075|160|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
6075|161|I|   Drug interactions may change how your medications work or||
6075|162|I|increase your risk for serious side effects. This document does||
6075|163|I|not contain all possible drug interactions. Keep a list of all||
6075|164|I|the products you use (including prescription/nonprescription||
6075|165|I|drugs and herbal products) and share it with your doctor and||
6075|166|I|pharmacist. Do not start, stop, or change the dosage of any||
6075|167|I|medicines without your doctor's approval.||
6075|168|I|   Some products that may interact with this drug are: aliskiren,||
6075|169|I|dofetilide, certain drugs that weaken the immune system/increase||
6075|170|I|the risk of infection (such as everolimus, sirolimus), lithium,||
6075|171|I|probenecid, drugs that may increase the level of potassium in the||
6075|172|I|blood (such as ARBs including losartan/valsartan, birth control||
6075|173|I|pills containing drospirenone), other "water pills" (diuretics||
6075|174|I|such as amiloride, furosemide, triamterene), gold injections,||
6075|175|I|sacubitril.||
6075|176|I|   A very serious reaction may occur if you are getting||
6075|177|I|injections for bee/wasp sting allergy (desensitization) and are||
6075|178|I|also taking captopril with hydrochlorothiazide. Make sure all||
6075|179|I|your doctors know which medicines you are using.||
6075|180|I|   Some products have ingredients that could raise your blood||
6075|181|I|pressure or worsen your heart failure. Tell your pharmacist what||
6075|182|I|products you are using, and ask how to use them safely||
6075|183|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
6075|184|I|ibuprofen/naproxen).||
6075|185|I|   This medication may interfere with certain lab tests, possibly||
6075|186|I|causing false test results. Make sure lab personnel and all your||
6075|187|I|doctors know you use this drug.||
6075|188|B|||
6075|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6075|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6075|191|O|poison control center right away. US residents can call||
6075|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6075|193|O|Symptoms of overdose may include severe dizziness, weakness,||
6075|194|O|fainting.||
6075|195|B|||
6075|196|N|NOTES:  Do not share this medication with others.||
6075|197|N|   Lifestyle changes such as stress reduction programs, exercise,||
6075|198|N|and dietary changes may increase the effectiveness of this||
6075|199|N|medicine. Talk to your doctor or pharmacist about lifestyle||
6075|200|N|changes that might benefit you.||
6075|201|N|   Lab and/or medical tests (such as sodium and potassium blood||
6075|202|N|levels, kidney function, skin exams, cholesterol levels) should||
6075|203|N|be done while you are taking this medication. Keep all medical||
6075|204|N|and lab appointments. Consult your doctor for more details.||
6075|205|N|   Check your blood pressure regularly while taking this||
6075|206|N|medication, especially when you first start this drug or when||
6075|207|N|your dose is changed. Learn how to monitor your own blood||
6075|208|N|pressure at home, and share the results with your doctor.||
6075|209|B|||
6075|210|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6075|211|D|remember. If it is near the time of the next dose, skip the||
6075|212|D|missed dose. Take your next dose at the regular time. Do not||
6075|213|D|double the dose to catch up.||
6075|214|B|||
6075|215|R|STORAGE:  Store at room temperature away from light and moisture.||
6075|216|R|Do not store in the bathroom. Keep all medications away from||
6075|217|R|children and pets.||
6075|218|R|   Do not flush medications down the toilet or pour them into a||
6075|219|R|drain unless instructed to do so. Properly discard this product||
6075|220|R|when it is expired or no longer needed. Consult your pharmacist||
6075|221|R|or local waste disposal company.||
6075|222|B|||
6075|223|A|Information last revised April 2025.||
6075|224|A|Copyright(c) 2025 First Databank, Inc.||
6075|225|B|||
6080|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6080|002|Z|does NOT have all possible information about this product. This||
6080|003|Z|information does not assure that this product is safe, effective,||
6080|004|Z|or appropriate for you. This information is not individual||
6080|005|Z|medical advice and does not substitute for the advice of your||
6080|006|Z|health care professional. Always ask your health care||
6080|007|Z|professional for complete information about this product and your||
6080|008|Z|specific health needs.||
6080|009|B|||
6080|010|T|DEXTROAMPHETAMINE/AMPHETAMINE- ORAL||
6080|011|F|(DEX-troe-am-FET-a-meen/am-FET-a-meen)||
6080|012|B|||
6080|013|C|COMMON BRAND NAME(S): Adderall||
6080|014|B|||
6080|015|W|WARNING:  Misuse or abuse of amphetamine may cause serious||
6080|016|W|(possibly fatal) heart and blood pressure problems.||
6080|017|W|Amphetamine-type medications can be habit-forming. Use only as||
6080|018|W|directed. If you use this drug for a long time, you may become||
6080|019|W|dependent on it and may have withdrawal symptoms after stopping||
6080|020|W|the drug. Consult your doctor or pharmacist for more details.||
6080|021|W|(See also How to Use section).||
6080|022|B|||
6080|023|U|USES:  This combination medication is used to treat attention||
6080|024|U|deficit hyperactivity disorder - ADHD. It works by changing the||
6080|025|U|amounts of certain natural substances in the brain.||
6080|026|U|Amphetamine/dextroamphetamine belongs to a class of drugs known||
6080|027|U|as stimulants. It can help increase your ability to pay||
6080|028|U|attention, stay focused on an activity, and control behavior||
6080|029|U|problems. It may also help you to organize your tasks and improve||
6080|030|U|listening skills.||
6080|031|U|   This drug is also used to treat a certain sleeping disorder||
6080|032|U|(narcolepsy) to help you stay awake during the day. It should not||
6080|033|U|be used to treat tiredness or to hold off sleep in people who do||
6080|034|U|not have a sleep disorder.||
6080|035|B|||
6080|036|H|HOW TO USE:  Read the Medication Guide provided by your||
6080|037|H|pharmacist before you start taking amphetamine/dextroamphetamine||
6080|038|H|and each time you get a refill. If you have any questions, ask||
6080|039|H|your doctor or pharmacist.||
6080|040|H|   Take this medication by mouth with or without food as directed||
6080|041|H|by your doctor, usually 1 to 3 times a day. The first dose is||
6080|042|H|usually taken when you wake up in the morning. If more doses are||
6080|043|H|prescribed, take them as directed by your doctor, usually 4-6||
6080|044|H|hours apart. Taking this medication late in the day may cause||
6080|045|H|trouble sleeping (insomnia).||
6080|046|H|   The dosage is based on your medical condition and response to||
6080|047|H|treatment. Your doctor may adjust your dose to find the dose that||
6080|048|H|is best for you. Follow your doctor's instructions carefully.||
6080|049|H|   Use this medication regularly to get the most benefit from it.||
6080|050|H|To help you remember, take it at the same time(s) each day.||
6080|051|H|   During treatment, your doctor may occasionally recommend||
6080|052|H|stopping the medication for a short time to see whether there are||
6080|053|H|any changes in your behavior and whether the medication is still||
6080|054|H|needed.||
6080|055|H|   If you suddenly stop using this medication, you may have||
6080|056|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
6080|057|H|mental/mood changes such as depression). To help prevent||
6080|058|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
6080|059|H|more likely if you have used this medication for a long time or||
6080|060|H|in high doses. Tell your doctor or pharmacist right away if you||
6080|061|H|have withdrawal.||
6080|062|H|   Though it helps many people, this medication may sometimes||
6080|063|H|cause addiction. This risk may be higher if you have a substance||
6080|064|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
6080|065|H|Do not increase your dose, take it more often, or use it for a||
6080|066|H|longer time than prescribed. Properly stop the medication when so||
6080|067|H|directed.||
6080|068|H|   When this medication is used for a long time, it may not work||
6080|069|H|as well. Talk with your doctor if this medication stops working||
6080|070|H|well.||
6080|071|H|   Tell your doctor if your condition does not get better or if||
6080|072|H|it gets worse.||
6080|073|B|||
6080|074|S|SIDE EFFECTS:  Loss of appetite, weight loss, dry mouth, stomach||
6080|075|S|upset/pain, nausea/vomiting, dizziness, headache, diarrhea,||
6080|076|S|fever, nervousness, and trouble sleeping may occur. If any of||
6080|077|S|these effects last or get worse, tell your doctor promptly.||
6080|078|S|   Remember that this medication has been prescribed because your||
6080|079|S|doctor has judged that the benefit to you is greater than the||
6080|080|S|risk of side effects. Many people using this medication do not||
6080|081|S|have serious side effects.||
6080|082|S|   This medication may raise your blood pressure. Check your||
6080|083|S|blood pressure regularly and tell your doctor if the results are||
6080|084|S|high.||
6080|085|S|   Tell your doctor right away if you have any serious side||
6080|086|S|effects, including: signs of blood flow problems in the fingers||
6080|087|S|or toes (such as coldness, numbness, pain, or skin color||
6080|088|S|changes), unusual wounds on the fingers or toes,||
6080|089|S|mental/mood/behavior changes (such as agitation, aggression, mood||
6080|090|S|swings, depression, abnormal thoughts, thoughts of suicide),||
6080|091|S|uncontrolled movements, continuous chewing movements/teeth||
6080|092|S|grinding, outbursts of words/sounds, change in sexual||
6080|093|S|ability/desire, frequent/prolonged erections (in males).||
6080|094|S|   Get medical help right away if you have any very serious side||
6080|095|S|effects, including: shortness of breath, chest/jaw/left arm pain,||
6080|096|S|fainting, severe headache, fast/pounding/irregular heartbeat,||
6080|097|S|seizures, swelling of the ankles/feet, extreme tiredness, blurred||
6080|098|S|vision, weakness on one side of the body, trouble speaking,||
6080|099|S|confusion.||
6080|100|S|   This medication may increase serotonin and rarely cause a very||
6080|101|S|serious condition called serotonin syndrome/toxicity. The risk||
6080|102|S|increases if you are also taking other drugs that increase||
6080|103|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
6080|104|S|take (see Drug Interactions section). Get medical help right away||
6080|105|S|if you develop some of the following symptoms: fast heartbeat,||
6080|106|S|hallucinations, loss of coordination, severe dizziness, severe||
6080|107|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
6080|108|S|unusual agitation/restlessness.||
6080|109|S|   A very serious allergic reaction to this drug is rare.||
6080|110|S|However, get medical help right away if you notice any symptoms||
6080|111|S|of a serious allergic reaction, including: rash, itching/swelling||
6080|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6080|113|S|breathing.||
6080|114|S|   This is not a complete list of possible side effects. If you||
6080|115|S|notice other effects not listed above, contact your doctor or||
6080|116|S|pharmacist.||
6080|117|S|   In the US -||
6080|118|S|   Call your doctor for medical advice about side effects. You||
6080|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6080|120|S|www.fda.gov/medwatch.||
6080|121|S|   In Canada - Call your doctor for medical advice about side||
6080|122|S|effects. You may report side effects to Health Canada at||
6080|123|S|1-866-234-2345.||
6080|124|B|||
6080|125|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
6080|126|P|pharmacist if you are allergic to it; or to other sympathomimetic||
6080|127|P|drugs (such as lisdexamfetamine); or if you have any other||
6080|128|P|allergies. This product may contain inactive ingredients, which||
6080|129|P|can cause allergic reactions or other problems. Talk to your||
6080|130|P|pharmacist for more details.||
6080|131|P|   Before using this medication, tell your doctor or pharmacist||
6080|132|P|your medical history, especially of: blood circulation problems||
6080|133|P|(such as Raynaud's disease), certain mental/mood conditions (such||
6080|134|P|as severe agitation, psychosis), personal/family history of||
6080|135|P|mental/mood disorders (such as bipolar disorder, depression,||
6080|136|P|psychotic disorder, suicidal thoughts), heart problems (including||
6080|137|P|irregular heartbeat/rhythm, coronary artery disease, heart||
6080|138|P|failure, cardiomyopathy, problems with the heart structure such||
6080|139|P|as valve problems), family history of heart problems (such as||
6080|140|P|sudden death/irregular heartbeat/rhythm), history of stroke, high||
6080|141|P|blood pressure, overactive thyroid (hyperthyroidism), a certain||
6080|142|P|eye problem (glaucoma), seizures, personal or family history of a||
6080|143|P|substance use disorder (such as overuse of or addiction to||
6080|144|P|drugs/alcohol), personal or family history of uncontrolled muscle||
6080|145|P|movements (such as Tourette's syndrome), kidney disease, liver||
6080|146|P|disease.||
6080|147|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6080|148|P|can make you more dizzy. Do not drive, use machinery, or do||
6080|149|P|anything that needs alertness until you can do it safely. Limit||
6080|150|P|alcoholic beverages. Talk to your doctor if you are using||
6080|151|P|marijuana (cannabis).||
6080|152|P|   Before having surgery, tell your doctor or dentist about all||
6080|153|P|the products you use (including prescription drugs,||
6080|154|P|nonprescription drugs, and herbal products).||
6080|155|P|   Children may be more sensitive to the side effects of this||
6080|156|P|drug, especially weight loss. This medication may slow down a||
6080|157|P|child's growth. The doctor may recommend temporarily stopping the||
6080|158|P|medication from time to time to reduce this risk. Monitor your||
6080|159|P|child's weight and height. Consult your doctor or pharmacist for||
6080|160|P|more details.||
6080|161|P|   Older adults may be more sensitive to the side effects of this||
6080|162|P|drug, especially chest pain, trouble sleeping, or weight loss.||
6080|163|P|   During pregnancy, this medication should be used only when||
6080|164|P|clearly needed. Discuss the risks and benefits with your doctor.||
6080|165|P|Infants born to mothers who are dependent on this medication may||
6080|166|P|be born too soon (premature) and have low birth weight. They may||
6080|167|P|also have withdrawal symptoms. Tell your doctor right away if you||
6080|168|P|notice possible mood changes, agitation, or unusual tiredness in||
6080|169|P|your newborn.||
6080|170|P|   This medication passes into breast milk and may have||
6080|171|P|undesirable effects on a nursing infant. Breastfeeding is not||
6080|172|P|recommended while using this medication. Consult your doctor||
6080|173|P|before breastfeeding.||
6080|174|B|||
6080|175|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6080|176|I|medications work or increase your risk for serious side effects.||
6080|177|I|This document does not contain all possible drug interactions.||
6080|178|I|Keep a list of all the products you use (including||
6080|179|I|prescription/nonprescription drugs and herbal products) and share||
6080|180|I|it with your doctor and pharmacist. Do not start, stop, or change||
6080|181|I|the dosage of any medicines without your doctor's approval.||
6080|182|I|   Taking MAO inhibitors with this medication may cause a serious||
6080|183|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
6080|184|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
6080|185|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
6080|186|I|selegiline, tranylcypromine) during treatment with this||
6080|187|I|medication. Most MAO inhibitors should also not be taken for two||
6080|188|I|weeks before treatment with this medication. Ask your doctor when||
6080|189|I|to start or stop taking this medication.||
6080|190|I|   Some products have ingredients that could raise your heart||
6080|191|I|rate or blood pressure. Tell your pharmacist what products you||
6080|192|I|are using, and ask how to use them safely (especially||
6080|193|I|cough-and-cold products or diet aids).||
6080|194|I|   The risk of serotonin syndrome/toxicity increases if you are||
6080|195|I|also taking other drugs that increase serotonin. Examples include||
6080|196|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
6080|197|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
6080|198|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
6080|199|I|serotonin syndrome/toxicity may be more likely when you start or||
6080|200|I|increase the dose of these drugs.||
6080|201|I|   Dextroamphetamine is very similar to lisdexamfetamine. Do not||
6080|202|I|use medications containing lisdexamfetamine while using||
6080|203|I|dextroamphetamine.||
6080|204|I|   This medication may interfere with certain medical/lab tests||
6080|205|I|(such as blood and urine steroid levels, brain scan for||
6080|206|I|Parkinson's disease), possibly causing false test results. Make||
6080|207|I|sure lab personnel and all your doctors know you use this drug.||
6080|208|B|||
6080|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6080|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6080|211|O|poison control center right away. US residents can call||
6080|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6080|213|O|Symptoms of overdose may include: headache that is severe or||
6080|214|O|doesn't go away, severe mental/mood changes, seizures, severe||
6080|215|O|restlessness, fast breathing.||
6080|216|B|||
6080|217|N|NOTES:  Do not share this medication with others. Sharing it is||
6080|218|N|against the law.||
6080|219|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
6080|220|N|growth monitoring in children) may be done while you are taking||
6080|221|N|this medication. Keep all medical and lab appointments. Consult||
6080|222|N|your doctor for more details.||
6080|223|B|||
6080|224|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
6080|225|D|in the morning hours. If it is late in the afternoon or near the||
6080|226|D|time of the next dose, skip the missed dose. Take your next dose||
6080|227|D|at the regular time. Do not double the dose to catch up.||
6080|228|B|||
6080|229|R|STORAGE:  Store at room temperature away from light and moisture.||
6080|230|R|Do not store in the bathroom. Keep all medications away from||
6080|231|R|children and pets.||
6080|232|R|   Do not flush medications down the toilet or pour them into a||
6080|233|R|drain unless instructed to do so. Properly discard this product||
6080|234|R|when it is expired or no longer needed. Consult your pharmacist||
6080|235|R|or local waste disposal company.||
6080|236|B|||
6080|237|A|Information last revised October 2024.||
6080|238|A|Copyright(c) 2025 First Databank, Inc.||
6080|239|B|||
6081|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6081|002|Z|does NOT have all possible information about this product. This||
6081|003|Z|information does not assure that this product is safe, effective,||
6081|004|Z|or appropriate for you. This information is not individual||
6081|005|Z|medical advice and does not substitute for the advice of your||
6081|006|Z|health care professional. Always ask your health care||
6081|007|Z|professional for complete information about this product and your||
6081|008|Z|specific health needs.||
6081|009|B|||
6081|010|T|BUTALBITAL/ASPIRIN/CAFFEINE - ORAL||
6081|011|F|(bue-TAL-bi-tal/AS-pir-in/KAF-een)||
6081|012|B|||
6081|013|C|COMMON BRAND NAME(S): Fiorinal||
6081|014|B|||
6081|015|U|USES:  This combination medication is used to treat tension||
6081|016|U|headaches. Aspirin helps to decrease the pain from the headache.||
6081|017|U|Caffeine helps increase the effects of aspirin. Butalbital is a||
6081|018|U|sedative that helps to decrease anxiety and cause sleepiness and||
6081|019|U|relaxation.||
6081|020|B|||
6081|021|V|OTHER USES:  This section contains uses of this drug that are not||
6081|022|V|listed in the approved professional labeling for the drug but||
6081|023|V|that may be prescribed by your health care professional. Use this||
6081|024|V|drug for a condition that is listed in this section only if it||
6081|025|V|has been so prescribed by your health care professional.||
6081|026|V|   This drug may also be used for migraine headaches.||
6081|027|B|||
6081|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
6081|029|H|doctor, usually every 4 hours as needed. Do not take more than 6||
6081|030|H|capsules/tablets in a 24-hour period. Take with a full glass of||
6081|031|H|water (8 ounces or 240 milliliters) unless your doctor directs||
6081|032|H|you otherwise. Do not lie down for at least 10 minutes after||
6081|033|H|taking this medication. To help prevent stomach upset, take it||
6081|034|H|with food or milk.||
6081|035|H|   The dosage is based on your medical condition and response to||
6081|036|H|treatment. This medication works best if it is used as the first||
6081|037|H|signs of a headache occur. If you wait until the headache has||
6081|038|H|worsened, the medication may not work as well.||
6081|039|H|   If you suddenly stop using this medication, you may have||
6081|040|H|withdrawal symptoms (such as nausea/vomiting, mental/mood||
6081|041|H|changes, seizures). To help prevent withdrawal, your doctor may||
6081|042|H|lower your dose slowly. Withdrawal is more likely if you have||
6081|043|H|used this medication for a long time or in high doses. Tell your||
6081|044|H|doctor or pharmacist right away if you have withdrawal.||
6081|045|H|   Though it helps many people, this medication may sometimes||
6081|046|H|cause addiction. This risk may be higher if you have a substance||
6081|047|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
6081|048|H|Do not increase your dose, take it more often, or use it for a||
6081|049|H|longer time than prescribed. Use the smallest effective dose.||
6081|050|H|Properly stop the medication when so directed.||
6081|051|H|   Tell your doctor if you notice increased use of this||
6081|052|H|medication, a worsening of headaches, an increase in the number||
6081|053|H|of headaches, the medication not working as well, or use of this||
6081|054|H|medication for more than 2 headache episodes a week. Your doctor||
6081|055|H|may need to change your medication and/or add a separate||
6081|056|H|medication to prevent the headaches.||
6081|057|B|||
6081|058|S|SIDE EFFECTS:  Nausea, vomiting, stomach upset, gas, shaking||
6081|059|S|(tremor), lightheadedness, dizziness, or drowsiness may occur. If||
6081|060|S|any of these effects last or get worse, tell your doctor or||
6081|061|S|pharmacist promptly.||
6081|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
6081|063|S|slowly when rising from a sitting or lying position.||
6081|064|S|   Remember that this medication has been prescribed because your||
6081|065|S|doctor has judged that the benefit to you is greater than the||
6081|066|S|risk of side effects. Many people using this medication do not||
6081|067|S|have serious side effects.||
6081|068|S|   Tell your doctor right away if you have any serious side||
6081|069|S|effects, including: mental/mood changes, fainting, fast/irregular||
6081|070|S|heartbeat, increased thirst/urination, hearing changes (such as||
6081|071|S|ringing in the ears), easy bruising/bleeding, heartburn,||
6081|072|S|discomfort when swallowing, dark urine, yellowing eyes/skin,||
6081|073|S|signs of kidney problems (such as change in the amount of urine),||
6081|074|S|unusual tiredness.||
6081|075|S|   Get medical help right away if you have any very serious side||
6081|076|S|effects, including: black stools, severe stomach/abdominal pain,||
6081|077|S|vomit that looks like coffee grounds, trouble speaking, weakness||
6081|078|S|on one side of the body.||
6081|079|S|   A very serious allergic reaction to this drug is rare.||
6081|080|S|However, get medical help right away if you notice any symptoms||
6081|081|S|of a serious allergic reaction, including: fever, swollen lymph||
6081|082|S|nodes, rash, itching/swelling (especially of the||
6081|083|S|face/tongue/throat), severe dizziness, trouble breathing.||
6081|084|S|   This is not a complete list of possible side effects. If you||
6081|085|S|notice other effects not listed above, contact your doctor or||
6081|086|S|pharmacist.||
6081|087|S|   In the US -||
6081|088|S|   Call your doctor for medical advice about side effects. You||
6081|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6081|090|S|www.fda.gov/medwatch.||
6081|091|S|   In Canada - Call your doctor for medical advice about side||
6081|092|S|effects. You may report side effects to Health Canada at||
6081|093|S|1-866-234-2345.||
6081|094|B|||
6081|095|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
6081|096|P|pharmacist if you are allergic to aspirin, caffeine, or||
6081|097|P|butalbital; or to other barbiturates (such as phenobarbital),||
6081|098|P|salicylates (such as salsalate), nonsteroidal anti-inflammatory||
6081|099|P|drugs (such as ibuprofen), or xanthine derivatives (such as||
6081|100|P|theophylline); or if you have any other allergies. This product||
6081|101|P|may contain inactive ingredients, which can cause allergic||
6081|102|P|reactions or other problems. Talk to your pharmacist for more||
6081|103|P|details.||
6081|104|P|   Before using this medication, tell your doctor or pharmacist||
6081|105|P|your medical history, especially of: breathing problems (such as||
6081|106|P|bronchopneumonia), a certain enzyme disorder (porphyria), asthma||
6081|107|P|(including a history of worsening breathing with runny/stuffy||
6081|108|P|nose after taking aspirin or other NSAIDs), stomach/bowel||
6081|109|P|problems (such as stomach/intestinal ulcers), bleeding/blood||
6081|110|P|clotting disorders (such as hemophilia, von Willebrand's disease,||
6081|111|P|thrombocytopenia), liver disease, kidney disease, heartburn,||
6081|112|P|gout, growths in the nose (nasal polyps), personal or family||
6081|113|P|history of a substance use disorder (such as overuse of or||
6081|114|P|addiction to drugs/alcohol), certain enzyme deficiencies||
6081|115|P|(pyruvate kinase or G6-PD deficiency), mental/mood disorders,||
6081|116|P|heart disease (such as irregular heartbeat, recent heart attack).||
6081|117|P|   Before having surgery or certain medical procedures (such as a||
6081|118|P|heart stress test or a procedure to restore a normal heart rhythm||
6081|119|P|if you have an unusually fast heartbeat), tell your doctor or||
6081|120|P|dentist that you use this medication and about all the products||
6081|121|P|you use (including prescription drugs, nonprescription drugs, and||
6081|122|P|herbal products).||
6081|123|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6081|124|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6081|125|P|machinery, or do anything that needs alertness until you can do||
6081|126|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6081|127|P|are using marijuana (cannabis).||
6081|128|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
6081|129|P|and tobacco, especially when combined with this medicine, may||
6081|130|P|increase your risk for stomach bleeding. Limit alcohol and stop||
6081|131|P|smoking. Consult your doctor or pharmacist for more information.||
6081|132|P|   This medication contains aspirin. Children and teenagers less||
6081|133|P|than 18 years old should not take aspirin if they have||
6081|134|P|chickenpox, flu, or any undiagnosed illness, or if they have just||
6081|135|P|been given a live virus vaccine, without first consulting a||
6081|136|P|doctor about Reye's syndrome, a rare but serious illness.||
6081|137|P|   Older adults may be more sensitive to the side effects of this||
6081|138|P|drug, especially drowsiness, stomach/intestinal bleeding and||
6081|139|P|ulcers, and trouble falling asleep. Drowsiness and trouble||
6081|140|P|falling asleep can increase the risk of falling.||
6081|141|P|   Before using this medication, women of childbearing age should||
6081|142|P|talk with their doctor(s) about the benefits and risks. Tell your||
6081|143|P|doctor if you are pregnant or if you plan to become pregnant.||
6081|144|P|This medication may harm an unborn baby and cause problems with||
6081|145|P|normal labor/delivery. It is not recommended for use in pregnancy||
6081|146|P|from 20 weeks until delivery. If your doctor decides that you||
6081|147|P|need to use this medication between 20 and 30 weeks of pregnancy,||
6081|148|P|you should use the lowest effective dose for the shortest||
6081|149|P|possible time. You should not use this medication after 30 weeks||
6081|150|P|of pregnancy.||
6081|151|P|   This drug passes into breast milk and could have undesirable||
6081|152|P|effects on a nursing infant. Breastfeeding is not recommended||
6081|153|P|while using this drug. Consult your doctor before breastfeeding.||
6081|154|B|||
6081|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6081|156|I|medications work or increase your risk for serious side effects.||
6081|157|I|This document does not contain all possible drug interactions.||
6081|158|I|Keep a list of all the products you use (including||
6081|159|I|prescription/nonprescription drugs and herbal products) and share||
6081|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
6081|161|I|the dosage of any medicines without your doctor's approval.||
6081|162|I|   Some products that may interact with this drug include:||
6081|163|I|acetazolamide, darunavir, dichlorphenamide, lithium,||
6081|164|I|6-mercaptopurine, methotrexate, methoxyflurane, mifepristone,||
6081|165|I|phenytoin, sodium oxybate, certain antibiotics (including||
6081|166|I|penicillin, sulfonamides such as sulfamethoxazole), certain drugs||
6081|167|I|used to treat gout (including uricosuric drugs such as||
6081|168|I|probenecid).||
6081|169|I|   This medication may increase the risk of bleeding when taken||
6081|170|I|with other drugs that also may cause bleeding. Examples include||
6081|171|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
6081|172|I|dabigatran/enoxaparin/warfarin, among others.||
6081|173|I|   This drug can speed up the removal of other drugs from your||
6081|174|I|body, which may affect how they work. Examples of affected drugs||
6081|175|I|include doxycycline, estrogen, felodipine, lonafarnib, quinidine,||
6081|176|I|rilpivirine, tamoxifen, theophylline, voriconazole, certain beta||
6081|177|I|blockers (such as metoprolol), corticosteroids (such as||
6081|178|I|prednisone), among others.||
6081|179|I|   Tell your doctor or pharmacist if you are taking other||
6081|180|I|products that cause drowsiness such as opioid pain or cough||
6081|181|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6081|182|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
6081|183|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6081|184|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6081|185|I|diphenhydramine).||
6081|186|I|   Check the labels on all your medicines (allergy or||
6081|187|I|cough-and-cold products, other headache medications) because they||
6081|188|I|may contain aspirin, caffeine, or ingredients that cause||
6081|189|I|drowsiness. Also keep in mind that certain beverages (such as||
6081|190|I|coffee, colas, tea) contain caffeine. Ask your pharmacist about||
6081|191|I|using those products safely.||
6081|192|I|   Check all prescription and nonprescription medicine labels||
6081|193|I|carefully since many medications contain pain relievers/fever||
6081|194|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
6081|195|I|naproxen). These drugs are similar to this medication and may||
6081|196|I|increase your risk of side effects if taken together. Ask your||
6081|197|I|doctor or pharmacist for more details.||
6081|198|I|   This medication may decrease the effectiveness of hormonal||
6081|199|I|birth control such as pills, patch, or ring. This could cause||
6081|200|I|pregnancy. Discuss with your doctor or pharmacist if you should||
6081|201|I|use reliable backup birth control methods while using this||
6081|202|I|medication. Also tell your doctor if you have any new spotting or||
6081|203|I|breakthrough bleeding, because these may be signs that your birth||
6081|204|I|control is not working well.||
6081|205|I|   This medication may interfere with certain medical/lab tests||
6081|206|I|(such as fasting blood glucose, cholesterol levels, prothrombin||
6081|207|I|time, urine 5-HIAA levels, urine VMA levels, certain urine||
6081|208|I|glucose tests, dipyridamole-thallium imaging tests), possibly||
6081|209|I|causing false test results. Make sure lab personnel and all your||
6081|210|I|doctors know you use this drug.||
6081|211|B|||
6081|212|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6081|213|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6081|214|O|poison control center right away. US residents can call||
6081|215|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6081|216|O|Symptoms of overdose may include: nausea/vomiting that doesn't||
6081|217|O|stop, severe drowsiness, slow breathing, severe dizziness,||
6081|218|O|ringing in the ears.||
6081|219|B|||
6081|220|N|NOTES:  Do not share this medication with others. Sharing it is||
6081|221|N|against the law.||
6081|222|N|   Massage, hot baths, and other relaxation methods can help with||
6081|223|N|tension headaches. Consult your doctor or pharmacist for more||
6081|224|N|details.||
6081|225|N|   Lab and/or medical tests (such as liver/kidney function) may||
6081|226|N|be done while you are taking this medication. Keep all medical||
6081|227|N|and lab appointments. Consult your doctor for more details.||
6081|228|B|||
6081|229|D|MISSED DOSE:  Not applicable.||
6081|230|B|||
6081|231|R|STORAGE:  Store at room temperature away from light and moisture.||
6081|232|R|Do not store in the bathroom. Keep all medications away from||
6081|233|R|children and pets.||
6081|234|R|   Do not flush medications down the toilet or pour them into a||
6081|235|R|drain unless instructed to do so. Properly discard this product||
6081|236|R|when it is expired or no longer needed. Consult your pharmacist||
6081|237|R|or local waste disposal company.||
6081|238|B|||
6081|239|A|Information last revised February 2025.||
6081|240|A|Copyright(c) 2025 First Databank, Inc.||
6081|241|B|||
6083|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6083|002|Z|does NOT have all possible information about this product. This||
6083|003|Z|information does not assure that this product is safe, effective,||
6083|004|Z|or appropriate for you. This information is not individual||
6083|005|Z|medical advice and does not substitute for the advice of your||
6083|006|Z|health care professional. Always ask your health care||
6083|007|Z|professional for complete information about this product and your||
6083|008|Z|specific health needs.||
6083|009|B|||
6083|010|T|CROMOLYN NEBULIZER SOLUTION - INHALATION||
6083|011|F|(KROE-mo-lin)||
6083|012|B|||
6083|013|C|COMMON BRAND NAME(S): Intal||
6083|014|B|||
6083|015|U|USES:  This medication is used to prevent symptoms (wheezing and||
6083|016|U|shortness of breath) caused by asthma. It is also used to prevent||
6083|017|U|wheezing and shortness of breath caused by exercise,||
6083|018|U|cold/dry/polluted air, or allergens such as pollen. Controlling||
6083|019|U|breathing problems may decrease time lost from work or school. If||
6083|020|U|you use this medication you may not need to use other asthma||
6083|021|U|drugs (such as corticosteroids) as often.||
6083|022|U|   Cromolyn belongs to a class of medications called mast cell||
6083|023|U|stabilizers. It works by preventing release of certain natural||
6083|024|U|chemicals (such as histamines) that may cause swelling of the||
6083|025|U|airways and breathing problems.||
6083|026|U|   This medication must be used regularly to prevent asthma||
6083|027|U|symptoms. It does not work right away and should not be used to||
6083|028|U|relieve sudden asthma attacks. If an asthma attack occurs, use||
6083|029|U|your quick-relief inhaler as prescribed.||
6083|030|B|||
6083|031|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
6083|032|H|your pharmacist before you start using cromolyn and each time you||
6083|033|H|get a refill. Follow the illustrated directions for the proper||
6083|034|H|use of this medication. If you have any questions, ask your||
6083|035|H|doctor or pharmacist.||
6083|036|H|   This product is used with special breathing equipment (power||
6083|037|H|nebulizer with face mask or mouthpiece). Make sure you understand||
6083|038|H|how to use the machine and how to properly clean it to prevent||
6083|039|H|infections. A parent or other responsible adult should supervise||
6083|040|H|a child who is using this type of machine. Ask your doctor,||
6083|041|H|pharmacist, or respiratory therapist about the proper use of the||
6083|042|H|equipment with this medication.||
6083|043|H|   Before using, check this product for particles or||
6083|044|H|discoloration. If either is present, do not use the liquid. Do||
6083|045|H|not mix this medication with other solutions or products in the||
6083|046|H|nebulizer.||
6083|047|H|   Inhale this medication by mouth as directed by your doctor,||
6083|048|H|usually 4 times daily. If you are using this medication to||
6083|049|H|prevent breathing problems related to exercise, cold/dry air, or||
6083|050|H|allergens, use it within 10 to 15 minutes, but not more than 60||
6083|051|H|minutes, before exposure. The dosage is based on your medical||
6083|052|H|condition, your age, response to treatment, and use of other||
6083|053|H|asthma medications. Your doctor may lower your dose once the||
6083|054|H|medication starts to work. Follow your doctor's instructions||
6083|055|H|carefully.||
6083|056|H|   If you are using other inhaled medications, ask your doctor||
6083|057|H|when to use each of the medications and in what order you should||
6083|058|H|use them.||
6083|059|H|   Learn which of your inhalers/medications you should use every||
6083|060|H|day (controller drugs) and which you should use if your breathing||
6083|061|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
6083|062|H|time what you should do if you have new or worsening cough or||
6083|063|H|shortness of breath, wheezing, increased sputum, worsening peak||
6083|064|H|flow meter readings, waking up at night with trouble breathing,||
6083|065|H|if you use your quick-relief inhaler more often (more than 2 days||
6083|066|H|a week), or if your quick-relief inhaler does not seem to be||
6083|067|H|working well. Learn when you can treat sudden breathing problems||
6083|068|H|by yourself and when you must get medical help right away.||
6083|069|H|   Use this medication regularly in order to get the most benefit||
6083|070|H|from it. This medication works best if always used at evenly||
6083|071|H|spaced intervals. To help you remember, use it at the same times||
6083|072|H|each day. Do not increase your dose, use it more often, or stop||
6083|073|H|using this medication without first asking your doctor.||
6083|074|H|   It may take up to 4 weeks of regular use before the full||
6083|075|H|benefit of this drug takes effect.||
6083|076|B|||
6083|077|S|SIDE EFFECTS:  Coughing, stuffy nose, sneezing, headache, nausea,||
6083|078|S|or tearing may occur. If any of these effects last or get worse,||
6083|079|S|tell your doctor or pharmacist promptly.||
6083|080|S|   Remember that this medication has been prescribed because your||
6083|081|S|doctor has judged that the benefit to you is greater than the||
6083|082|S|risk of side effects. Many people using this medication do not||
6083|083|S|have serious side effects.||
6083|084|S|   Tell your doctor right away if you have any serious side||
6083|085|S|effects, including: dizziness, painful/frequent urination, joint||
6083|086|S|swelling/pain, swollen glands around the cheek (parotid gland),||
6083|087|S|muscle weakness, heartburn.||
6083|088|S|   Rarely, this medication may cause severe sudden worsening of||
6083|089|S|breathing problems/asthma immediately after use. If you have||
6083|090|S|sudden worsening of breathing, use your quick-relief inhaler and||
6083|091|S|get medical help right away.||
6083|092|S|   A very serious allergic reaction to this drug is rare.||
6083|093|S|However, get medical help right away if you notice any symptoms||
6083|094|S|of a serious allergic reaction, including: rash, itching/swelling||
6083|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6083|096|S|breathing.||
6083|097|S|   This is not a complete list of possible side effects. If you||
6083|098|S|notice other effects not listed above, contact your doctor or||
6083|099|S|pharmacist.||
6083|100|S|   In the US -||
6083|101|S|   Call your doctor for medical advice about side effects. You||
6083|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6083|103|S|www.fda.gov/medwatch.||
6083|104|S|   In Canada - Call your doctor for medical advice about side||
6083|105|S|effects. You may report side effects to Health Canada at||
6083|106|S|1-866-234-2345.||
6083|107|B|||
6083|108|P|PRECAUTIONS:  Before using cromolyn, tell your doctor or||
6083|109|P|pharmacist if you are allergic to it; or if you have any other||
6083|110|P|allergies. This product may contain inactive ingredients, which||
6083|111|P|can cause allergic reactions or other problems. Talk to your||
6083|112|P|pharmacist for more details.||
6083|113|P|   Before using this medication, tell your doctor or pharmacist||
6083|114|P|your medical history, especially of: liver problems, kidney||
6083|115|P|problems.||
6083|116|P|   Before having surgery, tell your doctor or dentist about all||
6083|117|P|the products you use (including prescription drugs,||
6083|118|P|nonprescription drugs, and herbal products).||
6083|119|P|   During pregnancy, this medication should be used only when||
6083|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
6083|121|P|   It is unknown if this drug passes into breast milk. Consult||
6083|122|P|your doctor before breastfeeding.||
6083|123|B|||
6083|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6083|125|I|medications work or increase your risk for serious side effects.||
6083|126|I|This document does not contain all possible drug interactions.||
6083|127|I|Keep a list of all the products you use (including||
6083|128|I|prescription/nonprescription drugs and herbal products) and share||
6083|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
6083|130|I|the dosage of any medicines without your doctor's approval.||
6083|131|B|||
6083|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6083|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6083|134|O|poison control center right away. US residents can call||
6083|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6083|136|B|||
6083|137|N|NOTES:  Do not share this medication with others.||
6083|138|N|   Learn to use a peak flow meter, use it daily, and promptly||
6083|139|N|report worsening asthma (such as readings in the yellow/red||
6083|140|N|range, increased use of quick-relief inhalers).||
6083|141|N|   Avoid substances that can worsen breathing problems by causing||
6083|142|N|irritation or allergic reaction, such as smoke, pollen, pet||
6083|143|N|dander, dust, and mold.||
6083|144|N|   Because the flu virus can worsen breathing problems, ask your||
6083|145|N|doctor or pharmacist if you should have a flu shot every year.||
6083|146|B|||
6083|147|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6083|148|D|Use the remaining doses for that day at evenly spaced intervals.||
6083|149|D|Do not double the dose to catch up.||
6083|150|B|||
6083|151|R|STORAGE:  Store at room temperature in the foil pouches away from||
6083|152|R|light. Keep all medications away from children and pets.||
6083|153|R|   Do not flush medications down the toilet or pour them into a||
6083|154|R|drain unless instructed to do so. Properly discard this product||
6083|155|R|when it is expired or no longer needed. Consult your pharmacist||
6083|156|R|or local waste disposal company.||
6083|157|B|||
6083|158|A|Information last revised November 2025.||
6083|159|A|Copyright(c) 2025 First Databank, Inc.||
6083|160|B|||
6084|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6084|002|Z|does NOT have all possible information about this product. This||
6084|003|Z|information does not assure that this product is safe, effective,||
6084|004|Z|or appropriate for you. This information is not individual||
6084|005|Z|medical advice and does not substitute for the advice of your||
6084|006|Z|health care professional. Always ask your health care||
6084|007|Z|professional for complete information about this product and your||
6084|008|Z|specific health needs.||
6084|009|B|||
6084|010|T|CILOSTAZOL - ORAL||
6084|011|F|(sye-LOE-sta-zol)||
6084|012|B|||
6084|013|C|COMMON BRAND NAME(S): Pletal||
6084|014|B|||
6084|015|W|WARNING:  Medications similar to cilostazol have caused serious||
6084|016|W|(possibly fatal) problems in people with a certain type of heart||
6084|017|W|disease (heart failure). Do not use cilostazol if you have heart||
6084|018|W|failure.||
6084|019|B|||
6084|020|U|USES:  Cilostazol is used to improve the symptoms of a certain||
6084|021|U|blood flow problem in the legs (intermittent claudication).||
6084|022|U|Cilostazol can decrease the muscle pain/cramps that occur during||
6084|023|U|exercise/walking. Claudication pain is caused by too little||
6084|024|U|oxygen getting to the muscles. Cilostazol can increase blood flow||
6084|025|U|and the amount of oxygen that gets to the muscles.||
6084|026|U|   Cilostazol is an antiplatelet drug and a vasodilator. It works||
6084|027|U|by stopping blood cells called platelets from sticking together||
6084|028|U|and prevents them from forming harmful clots. It also widens||
6084|029|U|blood vessels in the legs. Cilostazol helps the blood to move||
6084|030|U|more easily and keeps blood flowing smoothly in your body.||
6084|031|B|||
6084|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6084|033|H|from your pharmacist before you start taking cilostazol and each||
6084|034|H|time you get a refill. If you have any questions, ask your doctor||
6084|035|H|or pharmacist.||
6084|036|H|   Take this medication by mouth without food as directed by your||
6084|037|H|doctor, usually twice daily, at least 30 minutes before or 2||
6084|038|H|hours after breakfast and dinner. The dosage is based on your||
6084|039|H|medical condition, response to treatment, and other medications||
6084|040|H|you may be taking. Be sure to tell your doctor and pharmacist||
6084|041|H|about all the products you use (including prescription drugs,||
6084|042|H|nonprescription drugs, and herbal products).||
6084|043|H|   Use this medication regularly to get the most benefit from it.||
6084|044|H|Remember to use it at the same times each day.||
6084|045|H|   Your symptoms may improve in 2-4 weeks, but it may take up to||
6084|046|H|12 weeks before you get the full benefit of this drug.||
6084|047|H|   Tell your doctor if your condition lasts or gets worse.||
6084|048|B|||
6084|049|S|SIDE EFFECTS:  Headache, diarrhea, runny nose, and dizziness may||
6084|050|S|occur. If any of these effects last or get worse, tell your||
6084|051|S|doctor or pharmacist promptly.||
6084|052|S|   Remember that this medication has been prescribed because your||
6084|053|S|doctor has judged that the benefit to you is greater than the||
6084|054|S|risk of side effects. Many people using this medication do not||
6084|055|S|have serious side effects.||
6084|056|S|   Tell your doctor right away if you have any serious side||
6084|057|S|effects, including: swelling hands/feet, easy bruising/bleeding,||
6084|058|S|black/bloody stools, vomit that looks like coffee grounds, signs||
6084|059|S|of infection (such as sore throat that doesn't go away, fever,||
6084|060|S|chills).||
6084|061|S|   Get medical help right away if you have any very serious side||
6084|062|S|effects, including: chest/jaw/left arm pain, fainting,||
6084|063|S|fast/pounding/irregular heartbeat, severe dizziness, vision||
6084|064|S|changes, weakness on one side of the body, trouble speaking,||
6084|065|S|confusion.||
6084|066|S|   A very serious allergic reaction to this drug is rare.||
6084|067|S|However, get medical help right away if you notice any symptoms||
6084|068|S|of a serious allergic reaction, including: rash, itching/swelling||
6084|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6084|070|S|breathing.||
6084|071|S|   This is not a complete list of possible side effects. If you||
6084|072|S|notice other effects not listed above, contact your doctor or||
6084|073|S|pharmacist.||
6084|074|S|   In the US -||
6084|075|S|   Call your doctor for medical advice about side effects. You||
6084|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6084|077|S|www.fda.gov/medwatch.||
6084|078|S|   In Canada - Call your doctor for medical advice about side||
6084|079|S|effects. You may report side effects to Health Canada at||
6084|080|S|1-866-234-2345.||
6084|081|B|||
6084|082|P|PRECAUTIONS:  See also Warning section.||
6084|083|P|   Before taking cilostazol, tell your doctor or pharmacist if||
6084|084|P|you are allergic to it; or if you have any other allergies. This||
6084|085|P|product may contain inactive ingredients, which can cause||
6084|086|P|allergic reactions or other problems. Talk to your pharmacist for||
6084|087|P|more details.||
6084|088|P|   Before using this medication, tell your doctor or pharmacist||
6084|089|P|your medical history, especially of: serious/active bleeding||
6084|090|P|(such as bleeding ulcers, bleeding in the eye/brain), blood||
6084|091|P|disorders (such as hemophilia, low platelet counts), heart||
6084|092|P|disease (such as heart attack, chest pain, fast/irregular||
6084|093|P|heartbeat), stroke, kidney disease.||
6084|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6084|095|P|can make you more dizzy. Do not drive, use machinery, or do||
6084|096|P|anything that needs alertness until you can do it safely. Limit||
6084|097|P|alcoholic beverages. Talk to your doctor if you are using||
6084|098|P|marijuana (cannabis).||
6084|099|P|   To lower the chance of getting cut, bruised, or injured, use||
6084|100|P|caution with sharp objects like razors and nail cutters, and||
6084|101|P|avoid activities such as contact sports.||
6084|102|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
6084|103|P|while using this medicine may increase your risk for stomach||
6084|104|P|bleeding. Limit alcoholic beverages. Ask your doctor or||
6084|105|P|pharmacist about how much alcohol you may safely drink.||
6084|106|P|   Cilostazol may cause a condition that affects the heart rhythm||
6084|107|P|(QT prolongation). QT prolongation can rarely cause serious||
6084|108|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
6084|109|P|as severe dizziness, fainting) that need medical attention right||
6084|110|P|away.||
6084|111|P|   The risk of QT prolongation may be increased if you have||
6084|112|P|certain medical conditions or are taking other drugs that may||
6084|113|P|cause QT prolongation. Before using cilostazol, tell your doctor||
6084|114|P|or pharmacist of all the drugs you take and if you have any of||
6084|115|P|the following conditions: certain heart problems (heart failure,||
6084|116|P|slow heartbeat, QT prolongation in the EKG), family history of||
6084|117|P|certain heart problems (QT prolongation in the EKG, sudden||
6084|118|P|cardiac death).||
6084|119|P|   Low levels of potassium or magnesium in the blood may also||
6084|120|P|increase your risk of QT prolongation. This risk may increase if||
6084|121|P|you use certain drugs (such as diuretics/"water pills") or if you||
6084|122|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6084|123|P|Talk to your doctor about using cilostazol safely.||
6084|124|P|   Before having surgery, tell your doctor or dentist about all||
6084|125|P|the products you use (including prescription drugs,||
6084|126|P|nonprescription drugs, and herbal products).||
6084|127|P|   Older adults may be more sensitive to the side effects of this||
6084|128|P|drug, especially swelling of the hands/feet (fluid retention) or||
6084|129|P|QT prolongation (see above).||
6084|130|P|   During pregnancy, this medication should be used only when||
6084|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
6084|132|P|   It is unknown if this medication passes into breast milk.||
6084|133|P|Consult your doctor before breastfeeding.||
6084|134|B|||
6084|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6084|136|I|medications work or increase your risk for serious side effects.||
6084|137|I|This document does not contain all possible drug interactions.||
6084|138|I|Keep a list of all the products you use (including||
6084|139|I|prescription/nonprescription drugs and herbal products) and share||
6084|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
6084|141|I|the dosage of any medicines without your doctor's approval.||
6084|142|I|   Some products that may interact with this drug include: "blood||
6084|143|I|thinners" (such as heparin, warfarin), certain other antiplatelet||
6084|144|I|drugs (such as dipyridamole), tipranavir.||
6084|145|I|   This medication is sometimes used together with other drugs||
6084|146|I|that may increase your risk of bleeding. Examples are certain||
6084|147|I|antiplatelet drugs (such as aspirin, clopidogrel). Follow your||
6084|148|I|doctor's instructions carefully and continue your medications as||
6084|149|I|directed. Tell your doctor if you notice unusual bleeding.||
6084|150|I|Consult your doctor or pharmacist for more details.||
6084|151|I|   Check all prescription and nonprescription medicine labels||
6084|152|I|carefully since many medications contain pain relievers/fever||
6084|153|I|reducers (aspirin, NSAIDs such as ibuprofen/naproxen) which can||
6084|154|I|increase the risk of bleeding/antiplatelet effect when used with||
6084|155|I|cilostazol. However, if your doctor has told you to take low-dose||
6084|156|I|aspirin to prevent heart attack or stroke (usually 81-162||
6084|157|I|milligrams a day), you should keep taking the aspirin unless your||
6084|158|I|doctor tells you not to. Ask your doctor or pharmacist for more||
6084|159|I|details.||
6084|160|B|||
6084|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6084|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6084|163|O|poison control center right away. US residents can call||
6084|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6084|165|O|Symptoms of overdose may include: severe headache, very||
6084|166|O|fast/irregular heartbeat, severe dizziness.||
6084|167|B|||
6084|168|N|NOTES:  Do not share this medication with others.||
6084|169|N|   Talk with your doctor about an exercise program to improve||
6084|170|N|walking and decrease pain.||
6084|171|N|   Lab and/or medical tests (such as complete blood count) should||
6084|172|N|be done while you are taking this medication. Keep all medical||
6084|173|N|and lab appointments. Consult your doctor for more details.||
6084|174|B|||
6084|175|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6084|176|D|If it is near the time of the next dose, skip the missed dose.||
6084|177|D|Use your next dose at the regular time. Do not double the dose to||
6084|178|D|catch up.||
6084|179|B|||
6084|180|R|STORAGE:  Store at room temperature away from light and moisture.||
6084|181|R|Do not store in the bathroom. Keep all medications away from||
6084|182|R|children and pets.||
6084|183|R|   Do not flush medications down the toilet or pour them into a||
6084|184|R|drain unless instructed to do so. Properly discard this product||
6084|185|R|when it is expired or no longer needed. Consult your pharmacist||
6084|186|R|or local waste disposal company.||
6084|187|B|||
6084|188|M|MEDICAL ALERT:  Your condition can cause complications in a||
6084|189|M|medical emergency. For information about enrolling in MedicAlert,||
6084|190|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6084|191|B|||
6084|192|A|Information last revised May 2025.||
6084|193|A|Copyright(c) 2025 First Databank, Inc.||
6084|194|B|||
6087|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6087|002|Z|does NOT have all possible information about this product. This||
6087|003|Z|information does not assure that this product is safe, effective,||
6087|004|Z|or appropriate for you. This information is not individual||
6087|005|Z|medical advice and does not substitute for the advice of your||
6087|006|Z|health care professional. Always ask your health care||
6087|007|Z|professional for complete information about this product and your||
6087|008|Z|specific health needs.||
6087|009|B|||
6087|010|T|METHOCARBAMOL - INJECTION||
6087|011|F|(METH-oh-KAR-ba-mol)||
6087|012|B|||
6087|013|C|COMMON BRAND NAME(S): Robaxin||
6087|014|B|||
6087|015|U|USES:  This medication is used to treat muscle spasms/pain. It is||
6087|016|U|usually used along with rest, physical therapy, and other||
6087|017|U|treatment. It may work by causing drowsiness and helping to relax||
6087|018|U|the muscles.||
6087|019|B|||
6087|020|H|HOW TO USE:  This medication is given by injection into a vein or||
6087|021|H|into a muscle as directed by your doctor. The injection is given||
6087|022|H|by a health care professional. If you are receiving this||
6087|023|H|medication by injection into a vein, your doctor may have you lie||
6087|024|H|down during the injection and for at least 10 to 15 minutes after||
6087|025|H|the injection to decrease the risk of side effects.||
6087|026|B|||
6087|027|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness,||
6087|028|S|nausea/vomiting, or blurred vision may occur.||
6087|029|S|Pain/redness/irritation at the injection site may also occur. If||
6087|030|S|any of these effects last or get worse, tell your doctor or||
6087|031|S|pharmacist promptly.||
6087|032|S|   Remember that this medication has been prescribed because your||
6087|033|S|doctor has judged that the benefit to you is greater than the||
6087|034|S|risk of side effects. Many people using this medication do not||
6087|035|S|have serious side effects.||
6087|036|S|   Tell your doctor right away if you have any serious side||
6087|037|S|effects, including: fainting, slow heartbeat, signs of liver||
6087|038|S|problems (such as nausea/vomiting that doesn't stop, loss of||
6087|039|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
6087|040|S|urine), mental/mood changes (such as confusion, memory problems).||
6087|041|S|   Get medical help right away if you have any very serious side||
6087|042|S|effects, including: seizure.||
6087|043|S|   A very serious allergic reaction to this drug is rare.||
6087|044|S|However, get medical help right away if you notice any symptoms||
6087|045|S|of a serious allergic reaction, including: rash, itching/swelling||
6087|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6087|047|S|breathing.||
6087|048|S|   This is not a complete list of possible side effects. If you||
6087|049|S|notice other effects not listed above, contact your doctor or||
6087|050|S|pharmacist.||
6087|051|S|   In the US -||
6087|052|S|   Call your doctor for medical advice about side effects. You||
6087|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6087|054|S|www.fda.gov/medwatch.||
6087|055|S|   In Canada - Call your doctor for medical advice about side||
6087|056|S|effects. You may report side effects to Health Canada at||
6087|057|S|1-866-234-2345.||
6087|058|B|||
6087|059|P|PRECAUTIONS:  Before using methocarbamol, tell your doctor or||
6087|060|P|pharmacist if you are allergic to it; or if you have any other||
6087|061|P|allergies. This product may contain inactive ingredients, which||
6087|062|P|can cause allergic reactions or other problems. Talk to your||
6087|063|P|pharmacist for more details.||
6087|064|P|   Before using this medication, tell your doctor or pharmacist||
6087|065|P|your medical history, especially of: kidney disease, liver||
6087|066|P|problems, seizure disorder.||
6087|067|P|   This drug may make you dizzy or drowsy or cause blurred||
6087|068|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
6087|069|P|or drowsy. Do not drive, use machinery, or do anything that needs||
6087|070|P|alertness or clear vision until you can do it safely. Avoid||
6087|071|P|alcoholic beverages. Talk to your doctor if you are using||
6087|072|P|marijuana (cannabis).||
6087|073|P|   Before having surgery, tell your doctor or dentist about all||
6087|074|P|the products you use (including prescription drugs,||
6087|075|P|nonprescription drugs, and herbal products).||
6087|076|P|   Older adults may be more sensitive to the side effects of this||
6087|077|P|drug, especially confusion, dizziness, or drowsiness. These side||
6087|078|P|effects can increase the risk of falling.||
6087|079|P|   During pregnancy, this medication should be used only when||
6087|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
6087|081|P|   It is unknown if this medication passes into breast milk.||
6087|082|P|Consult your doctor before breastfeeding.||
6087|083|B|||
6087|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6087|085|I|medications work or increase your risk for serious side effects.||
6087|086|I|This document does not contain all possible drug interactions.||
6087|087|I|Keep a list of all the products you use (including||
6087|088|I|prescription/nonprescription drugs and herbal products) and share||
6087|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
6087|090|I|the dosage of any medicines without your doctor's approval.||
6087|091|I|   Tell your doctor or pharmacist if you are taking other||
6087|092|I|products that cause drowsiness such as opioid pain or cough||
6087|093|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6087|094|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
6087|095|I|lorazepam, zolpidem), other muscle relaxants (such as||
6087|096|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
6087|097|I|cetirizine, diphenhydramine).||
6087|098|I|   Check the labels on all your medicines (such as allergy or||
6087|099|I|cough-and-cold products) because they may contain ingredients||
6087|100|I|that cause drowsiness. Ask your pharmacist about using those||
6087|101|I|products safely.||
6087|102|I|   This medication may interfere with certain lab tests (such as||
6087|103|I|VMA or 5-HIAA urine screening tests), possibly causing false test||
6087|104|I|results. Make sure lab personnel and all your doctors know you||
6087|105|I|use this drug.||
6087|106|B|||
6087|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6087|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6087|109|O|poison control center right away. US residents can call||
6087|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6087|111|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
6087|112|O|seizure, loss of consciousness.||
6087|113|B|||
6087|114|N|NOTES:  Do not share this medication with others.||
6087|115|B|||
6087|116|D|MISSED DOSE:  Not applicable.||
6087|117|B|||
6087|118|R|STORAGE:  Not applicable. This medication is given in a hospital||
6087|119|R|or clinic or doctor's office and will not be stored at home.||
6087|120|B|||
6087|121|A|Information last revised May 2024.||
6087|122|A|Copyright(c) 2025 First Databank, Inc.||
6087|123|B|||
6090|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6090|002|Z|does NOT have all possible information about this product. This||
6090|003|Z|information does not assure that this product is safe, effective,||
6090|004|Z|or appropriate for you. This information is not individual||
6090|005|Z|medical advice and does not substitute for the advice of your||
6090|006|Z|health care professional. Always ask your health care||
6090|007|Z|professional for complete information about this product and your||
6090|008|Z|specific health needs.||
6090|009|B|||
6090|010|T|DOMPERIDONE - ORAL||
6090|011|F|(dome-PER-i-done)||
6090|012|B|||
6090|013|W|WARNING:  Domperidone has rarely caused very serious (possibly||
6090|014|W|fatal) heart rhythm disorder. The risk is greater in older adults||
6090|015|W|and in people who take more of the drug than recommended. Get||
6090|016|W|medical help right away if you develop symptoms of heart rhythm||
6090|017|W|disorder, such as severe dizziness, fainting, fast/slow/irregular||
6090|018|W|heartbeat. See also Precautions section.||
6090|019|B|||
6090|020|U|USES:  This medication is used to treat disorders caused by||
6090|021|U|decreased movement of the stomach and upper intestines (such as||
6090|022|U|diabetic gastroparesis, gastritis). It works by increasing||
6090|023|U|stomach emptying and movement of the upper intestines. Treating||
6090|024|U|these disorders can help decrease symptoms such as nausea,||
6090|025|U|vomiting, heartburn, and constant feeling of stomach fullness.||
6090|026|U|   This medication is also used to prevent side effects (such as||
6090|027|U|nausea, vomiting) from certain medications used to treat||
6090|028|U|Parkinson's disease (including levodopa, dopamine agonists such||
6090|029|U|as pergolide).||
6090|030|B|||
6090|031|V|OTHER USES:  This section contains uses of this drug that are not||
6090|032|V|listed in the approved professional labeling for the drug but||
6090|033|V|that may be prescribed by your health care professional. Use this||
6090|034|V|drug for a condition that is listed in this section only if it||
6090|035|V|has been so prescribed by your health care professional.||
6090|036|V|   This drug may also be used for nausea and vomiting from other||
6090|037|V|causes (such as chemotherapy, migraine headaches).||
6090|038|B|||
6090|039|H|HOW TO USE:  Take this medication by mouth as directed by your||
6090|040|H|doctor, usually 3 times daily (15 to 30 minutes before meals).||
6090|041|H|   The dosage is based on your medical condition and response to||
6090|042|H|treatment.||
6090|043|H|   Do not increase your dose or use this drug more often or for||
6090|044|H|longer than prescribed. Your condition will not improve any||
6090|045|H|faster, and your risk of serious side effects (such as irregular||
6090|046|H|heartbeat, tardive dyskinesia) will increase. See also Side||
6090|047|H|Effects and Warning section.||
6090|048|H|   Avoid eating grapefruit or drinking grapefruit juice while||
6090|049|H|using this medication unless your doctor or pharmacist says you||
6090|050|H|may do so safely. Grapefruit can increase the chance of side||
6090|051|H|effects with this medicine. Ask your doctor or pharmacist for||
6090|052|H|more details.||
6090|053|H|   Tell your doctor if your condition lasts or gets worse.||
6090|054|B|||
6090|055|S|SIDE EFFECTS:  See also Warning section.||
6090|056|S|   Headache, dry mouth, diarrhea, or abdominal cramping may||
6090|057|S|occur. If any of these effects last or get worse, tell your||
6090|058|S|doctor or pharmacist promptly.||
6090|059|S|   Remember that this medication has been prescribed because your||
6090|060|S|doctor has judged that the benefit to you is greater than the||
6090|061|S|risk of side effects. Many people using this medication do not||
6090|062|S|have serious side effects.||
6090|063|S|   Tell your doctor right away if you have any serious side||
6090|064|S|effects, including: swelling of the ankles/feet, unusual||
6090|065|S|tiredness, mental/mood changes (such as nervousness,||
6090|066|S|irritability, restlessness), hot flashes, breast swelling/pain,||
6090|067|S|unusual leakage of milk from the breast, changes in menstrual||
6090|068|S|periods, decreased sexual ability, drooling/trouble swallowing,||
6090|069|S|shaking (tremor), muscle spasm/stiffness, mask-like expression of||
6090|070|S|the face.||
6090|071|S|   Rarely, domperidone may cause face/muscle twitching and||
6090|072|S|uncontrollable movements (tardive dyskinesia). In some cases,||
6090|073|S|this condition may be permanent. Tell your doctor right away if||
6090|074|S|you develop any uncontrollable movements such as lip smacking,||
6090|075|S|mouth puckering, or other unusual movements.||
6090|076|S|   A very serious allergic reaction to this drug is rare.||
6090|077|S|However, get medical help right away if you notice any symptoms||
6090|078|S|of a serious allergic reaction, including: rash, itching/swelling||
6090|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6090|080|S|breathing.||
6090|081|S|   This is not a complete list of possible side effects. If you||
6090|082|S|notice other effects not listed above, contact your doctor or||
6090|083|S|pharmacist.||
6090|084|S|   In the US -||
6090|085|S|   Call your doctor for medical advice about side effects. You||
6090|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6090|087|S|www.fda.gov/medwatch.||
6090|088|S|   In Canada - Call your doctor for medical advice about side||
6090|089|S|effects. You may report side effects to Health Canada at||
6090|090|S|1-866-234-2345.||
6090|091|B|||
6090|092|P|PRECAUTIONS:  Before taking domperidone, tell your doctor or||
6090|093|P|pharmacist if you are allergic to it; or if you have any other||
6090|094|P|allergies. This product may contain inactive ingredients, which||
6090|095|P|can cause allergic reactions or other problems. Talk to your||
6090|096|P|pharmacist for more details.||
6090|097|P|   Before using this medication, tell your doctor or pharmacist||
6090|098|P|your medical history, especially of: recent stomach/intestinal||
6090|099|P|surgery, bleeding/blockage/hole in the intestines/stomach, a||
6090|100|P|certain tumor of the pituitary gland (prolactinoma), breast||
6090|101|P|cancer, liver disease, kidney disease, decreased or no stomach||
6090|102|P|acid (achlorhydria).||
6090|103|P|   Domperidone may cause a condition that affects the heart||
6090|104|P|rhythm (QT prolongation). QT prolongation can rarely cause||
6090|105|P|serious (rarely fatal) fast/irregular heartbeat and other||
6090|106|P|symptoms (such as severe dizziness, fainting) that need medical||
6090|107|P|attention right away.||
6090|108|P|   The risk of QT prolongation may be increased if you have||
6090|109|P|certain medical conditions or are taking other drugs that may||
6090|110|P|cause QT prolongation. Before using domperidone, tell your doctor||
6090|111|P|or pharmacist of all the drugs you take and if you have any of||
6090|112|P|the following conditions: certain heart problems (heart failure,||
6090|113|P|slow heartbeat, QT prolongation in the EKG), family history of||
6090|114|P|certain heart problems (QT prolongation in the EKG, sudden||
6090|115|P|cardiac death).||
6090|116|P|   Low levels of potassium or magnesium in the blood may also||
6090|117|P|increase your risk of QT prolongation. This risk may increase if||
6090|118|P|you use certain drugs (such as diuretics/"water pills") or if you||
6090|119|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6090|120|P|Talk to your doctor about using domperidone safely.||
6090|121|P|   Older adults may be at greater risk for very serious irregular||
6090|122|P|heartbeats (arrhythmias) and QT prolongation (see above).||
6090|123|P|   During pregnancy, this medication should be used only when||
6090|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
6090|125|P|   Domperidone passes into breast milk in small amounts. Consult||
6090|126|P|your doctor before breastfeeding.||
6090|127|B|||
6090|128|I|DRUG INTERACTIONS:  See also How to Use section.||
6090|129|I|   Drug interactions may change how your medications work or||
6090|130|I|increase your risk for serious side effects. This document does||
6090|131|I|not contain all possible drug interactions. Keep a list of all||
6090|132|I|the products you use (including prescription/nonprescription||
6090|133|I|drugs and herbal products) and share it with your doctor and||
6090|134|I|pharmacist. Do not start, stop, or change the dosage of any||
6090|135|I|medicines without your doctor's approval.||
6090|136|I|   A product that may interact with this drug is: pramlintide.||
6090|137|I|   Many drugs besides domperidone may affect the heart rhythm (QT||
6090|138|I|prolongation), such as amiodarone, bepridil, disopyramide,||
6090|139|I|dofetilide, droperidol, levomethadyl, mesoridazine, pimozide,||
6090|140|I|procainamide, quinidine, ranolazine, sotalol, thioridazine,||
6090|141|I|ziprasidone, among others.||
6090|142|I|   Other medications can affect the removal of domperidone from||
6090|143|I|your body, which may affect how domperidone works. Examples||
6090|144|I|include certain azole antifungals (such as ketoconazole,||
6090|145|I|voriconazole), cimetidine, cobicistat, certain macrolide||
6090|146|I|antibiotics (such as clarithromycin, erythromycin), HIV protease||
6090|147|I|inhibitors (such as nelfinavir), nefazodone, rifamycins (such as||
6090|148|I|rifabutin), ritonavir, certain drugs used to treat seizures (such||
6090|149|I|as carbamazepine), telithromycin, among others.||
6090|150|B|||
6090|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6090|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6090|153|O|poison control center right away. US residents can call||
6090|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6090|155|O|Symptoms of overdose may include: fast/slow/irregular heartbeat,||
6090|156|O|severe dizziness, drowsiness, muscle stiffness/spasm/twitching.||
6090|157|B|||
6090|158|N|NOTES:  Do not share this medication with others.||
6090|159|B|||
6090|160|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6090|161|D|remember. If it is near the time of the next dose, skip the||
6090|162|D|missed dose. Take your next dose at the regular time. Do not||
6090|163|D|double the dose to catch up.||
6090|164|B|||
6090|165|R|STORAGE:  Store at room temperature away from light and moisture.||
6090|166|R|Do not store in the bathroom. Keep all medications away from||
6090|167|R|children and pets.||
6090|168|R|   Do not flush medications down the toilet or pour them into a||
6090|169|R|drain unless instructed to do so. Properly discard this product||
6090|170|R|when it is expired or no longer needed. Consult your pharmacist||
6090|171|R|or local waste disposal company.||
6090|172|B|||
6090|173|A|Information last revised May 2025.||
6090|174|A|Copyright(c) 2025 First Databank, Inc.||
6090|175|B|||
6093|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6093|002|Z|does NOT have all possible information about this product. This||
6093|003|Z|information does not assure that this product is safe, effective,||
6093|004|Z|or appropriate for you. This information is not individual||
6093|005|Z|medical advice and does not substitute for the advice of your||
6093|006|Z|health care professional. Always ask your health care||
6093|007|Z|professional for complete information about this product and your||
6093|008|Z|specific health needs.||
6093|009|B|||
6093|010|T|CIPROFLOXACIN DROPS - OPHTHALMIC||
6093|011|F|(SIP-roe-FLOX-a-sin)||
6093|012|B|||
6093|013|C|COMMON BRAND NAME(S): Ciloxan||
6093|014|B|||
6093|015|U|USES:  This medication is used to treat eye infections.||
6093|016|U|Ciprofloxacin belongs to a class of drugs called quinolone||
6093|017|U|antibiotics. It works by stopping the growth of bacteria.||
6093|018|U|   This medication treats only bacterial eye infections. It will||
6093|019|U|not work for other types of eye infections. Unnecessary use or||
6093|020|U|overuse of any antibiotic can lead to its decreased||
6093|021|U|effectiveness.||
6093|022|B|||
6093|023|H|HOW TO USE:  To apply eye drops, wash your hands first. To avoid||
6093|024|H|contamination, do not touch the dropper tip or let it touch your||
6093|025|H|eye or any other surface.||
6093|026|H|   Do not wear contact lenses while you are using this medicine.||
6093|027|H|Sterilize contact lenses according to manufacturer's directions||
6093|028|H|and check with your doctor before using them.||
6093|029|H|   Tilt your head back, look upward and pull down the lower||
6093|030|H|eyelid to make a pouch. Hold the dropper directly over your eye||
6093|031|H|and place one drop into it. Look downward and gently close your||
6093|032|H|eyes for 1 to 2 minutes. Place one finger at the corner of your||
6093|033|H|eye (near the nose) and apply gentle pressure. This will prevent||
6093|034|H|the medication from draining out. Try not to blink and do not rub||
6093|035|H|your eye. Repeat these steps for your other eye if so directed,||
6093|036|H|and if your dose is for more than 1 drop.||
6093|037|H|   Do not rinse the dropper. Replace the dropper cap after each||
6093|038|H|use.||
6093|039|H|   If you are using another kind of eye medication (such as drops||
6093|040|H|or ointments), wait at least 5 minutes before applying other||
6093|041|H|medications. Use eye drops before eye ointments to allow the eye||
6093|042|H|drops to enter the eye.||
6093|043|H|   Wait several minutes for your vision to clear before driving||
6093|044|H|or operating machinery.||
6093|045|H|   Use this medication regularly in order to get the most benefit||
6093|046|H|from it. Continue to use this medication for the full time||
6093|047|H|prescribed, even if symptoms disappear after a few days. Stopping||
6093|048|H|the medication too early may result in a return of the infection.||
6093|049|H|   Tell your doctor if your condition lasts or gets worse.||
6093|050|B|||
6093|051|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
6093|052|S|eyes for a minute or two when applied. Eye discomfort, itching,||
6093|053|S|redness, tearing, eyelid crusting, feeling as if something is in||
6093|054|S|your eye, blurred vision, a bad taste in your mouth, or||
6093|055|S|sensitivity to light may occur. If any of these effects last or||
6093|056|S|get worse, tell your doctor or pharmacist promptly.||
6093|057|S|   White crystals may appear in the treated eye(s) after the||
6093|058|S|first few days of ciprofloxacin use, but usually go away in a few||
6093|059|S|weeks. This effect is harmless. Keep your scheduled appointments||
6093|060|S|so your doctor can closely monitor your eye infection. If you||
6093|061|S|notice any new or worsening eye symptoms (such as increased||
6093|062|S|discharge, eye pain), tell your doctor right away.||
6093|063|S|   Remember that this medication has been prescribed because your||
6093|064|S|doctor has judged that the benefit to you is greater than the||
6093|065|S|risk of side effects. Many people using this medication do not||
6093|066|S|have serious side effects.||
6093|067|S|   Use of this medication for prolonged or repeated periods may||
6093|068|S|result in a new fungal eye infection. Do not use it for longer||
6093|069|S|than prescribed. Contact your doctor if you notice new or||
6093|070|S|worsening symptoms.||
6093|071|S|   Tell your doctor right away if you have any serious side||
6093|072|S|effects, including: staining of the eyes, swelling in or around||
6093|073|S|the eye, eye pain, worsening vision.||
6093|074|S|   A very serious allergic reaction to this drug is rare.||
6093|075|S|However, get medical help right away if you notice any symptoms||
6093|076|S|of a serious allergic reaction, including: rash, itching/swelling||
6093|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6093|078|S|breathing.||
6093|079|S|   This is not a complete list of possible side effects. If you||
6093|080|S|notice other effects not listed above, contact your doctor or||
6093|081|S|pharmacist.||
6093|082|S|   In the US -||
6093|083|S|   Call your doctor for medical advice about side effects. You||
6093|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6093|085|S|www.fda.gov/medwatch.||
6093|086|S|   In Canada - Call your doctor for medical advice about side||
6093|087|S|effects. You may report side effects to Health Canada at||
6093|088|S|1-866-234-2345.||
6093|089|B|||
6093|090|P|PRECAUTIONS:  Before using ciprofloxacin, tell your doctor or||
6093|091|P|pharmacist if you are allergic to it; or to other quinolones||
6093|092|P|(such as levofloxacin, moxifloxacin); or if you have any other||
6093|093|P|allergies. This product may contain inactive ingredients (such as||
6093|094|P|preservatives like benzalkonium chloride), which can cause||
6093|095|P|allergic reactions or other problems. Talk to your pharmacist for||
6093|096|P|more details.||
6093|097|P|   Before using this medication, tell your doctor or pharmacist||
6093|098|P|your medical history, especially of: contact lens use, other eye||
6093|099|P|problems.||
6093|100|P|   After you apply this drug, your vision may become temporarily||
6093|101|P|blurred or unstable. Do not drive, use machinery, or do anything||
6093|102|P|that needs clear vision until you can do it safely.||
6093|103|P|   During pregnancy, this medication should be used only when||
6093|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
6093|105|P|   It is unknown if this medication passes into breast milk.||
6093|106|P|Consult your doctor before breastfeeding.||
6093|107|B|||
6093|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6093|109|I|medications work or increase your risk for serious side effects.||
6093|110|I|This document does not contain all possible drug interactions.||
6093|111|I|Keep a list of all the products you use (including||
6093|112|I|prescription/nonprescription drugs and herbal products) and share||
6093|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
6093|114|I|the dosage of any medicines without your doctor's approval.||
6093|115|B|||
6093|116|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6093|117|O|has overdosed and has serious symptoms such as passing out or||
6093|118|O|trouble breathing, call 911. Otherwise, call a poison control||
6093|119|O|center right away. US residents can call 1-800-222-1222. Canada||
6093|120|O|residents can call 1-844-764-7669.||
6093|121|B|||
6093|122|N|NOTES:  Do not share this medication with others.||
6093|123|N|   This medication has been prescribed for your current condition||
6093|124|N|only. Throw away the unused medication after treatment is||
6093|125|N|completed. Do not use it later for another infection unless your||
6093|126|N|doctor tells you to.||
6093|127|B|||
6093|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6093|129|D|If it is near the time of the next dose, skip the missed dose.||
6093|130|D|Use your next dose at the regular time. Do not double the dose to||
6093|131|D|catch up.||
6093|132|B|||
6093|133|R|STORAGE:  Store at room temperature away from light. Do not||
6093|134|R|freeze. Discard the solution if it changes color, becomes cloudy,||
6093|135|R|or develops particles. Keep all medications away from children||
6093|136|R|and pets.||
6093|137|R|   Do not flush medications down the toilet or pour them into a||
6093|138|R|drain unless instructed to do so. Properly discard this product||
6093|139|R|when it is expired or no longer needed. Consult your pharmacist||
6093|140|R|or local waste disposal company.||
6093|141|B|||
6093|142|A|Information last revised May 2024.||
6093|143|A|Copyright(c) 2025 First Databank, Inc.||
6093|144|B|||
6095|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6095|002|Z|does NOT have all possible information about this product. This||
6095|003|Z|information does not assure that this product is safe, effective,||
6095|004|Z|or appropriate for you. This information is not individual||
6095|005|Z|medical advice and does not substitute for the advice of your||
6095|006|Z|health care professional. Always ask your health care||
6095|007|Z|professional for complete information about this product and your||
6095|008|Z|specific health needs.||
6095|009|B|||
6095|010|T|PAROXETINE SUSPENSION - ORAL||
6095|011|F|(pa-ROX-e-teen)||
6095|012|B|||
6095|013|C|COMMON BRAND NAME(S): Paxil||
6095|014|B|||
6095|015|W|WARNING:  Antidepressant medications are used to treat a variety||
6095|016|W|of conditions, including depression and other mental/mood||
6095|017|W|disorders. These medications can help prevent suicidal||
6095|018|W|thoughts/attempts and provide other important benefits. However,||
6095|019|W|studies have shown that a small number of people (especially||
6095|020|W|people younger than 25) who take antidepressants for any||
6095|021|W|condition may experience worsening depression, other mental/mood||
6095|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
6095|023|W|talk with the doctor about the risks and benefits of||
6095|024|W|antidepressant medication (especially for people younger than||
6095|025|W|25), even if treatment is not for a mental/mood condition.||
6095|026|W|   Tell the doctor right away if you notice worsening||
6095|027|W|depression/other psychiatric conditions, unusual behavior changes||
6095|028|W|(including possible suicidal thoughts/attempts), or other||
6095|029|W|mental/mood changes (including new/worsening anxiety, panic||
6095|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
6095|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
6095|032|W|especially watchful for these symptoms when a new antidepressant||
6095|033|W|is started or when the dose is changed.||
6095|034|B|||
6095|035|U|USES:  This medication is used to treat certain mental/mood||
6095|036|U|disorders (such as depression, panic attacks, obsessive||
6095|037|U|compulsive disorder, anxiety disorders, post-traumatic stress||
6095|038|U|disorder). Paroxetine belongs to a class of drugs known as||
6095|039|U|selective serotonin reuptake inhibitors (SSRIs). It works by||
6095|040|U|helping to restore the balance of a certain natural substance||
6095|041|U|(serotonin) in the brain.||
6095|042|B|||
6095|043|V|OTHER USES:  This section contains uses of this drug that are not||
6095|044|V|listed in the approved professional labeling for the drug but||
6095|045|V|that may be prescribed by your health care professional. Use this||
6095|046|V|drug for a condition that is listed in this section only if it||
6095|047|V|has been so prescribed by your health care professional.||
6095|048|V|   This drug may also be used for a severe form of premenstrual||
6095|049|V|syndrome (premenstrual dysphoric disorder), or for hot flashes||
6095|050|V|that occur with menopause.||
6095|051|B|||
6095|052|H|HOW TO USE:  Read the Medication Guide provided by your||
6095|053|H|pharmacist before you start using paroxetine and each time you||
6095|054|H|get a refill. If you have any questions, consult your doctor or||
6095|055|H|pharmacist.||
6095|056|H|   Shake the bottle well before each dose. Measure the dose||
6095|057|H|carefully using a special measuring device/spoon. Do not use a||
6095|058|H|household spoon because you may not get the correct dose.||
6095|059|H|   Take this medication by mouth with or without food as directed||
6095|060|H|by your doctor, usually once daily in the morning. Taking this||
6095|061|H|medication with food may decrease nausea. If this medication||
6095|062|H|makes you sleepy during the day, talk to your doctor about taking||
6095|063|H|it in the evening.||
6095|064|H|   The dosage is based on your medical condition, response to||
6095|065|H|treatment, age, and other medications you may be taking. Be sure||
6095|066|H|to tell your doctor and pharmacist about all the products you use||
6095|067|H|(including prescription drugs, nonprescription drugs, and herbal||
6095|068|H|products). To reduce your risk of side effects, your doctor may||
6095|069|H|start you at a low dose and gradually increase your dose. Follow||
6095|070|H|your doctor's instructions carefully. Do not increase your dose||
6095|071|H|or use this drug more often or for longer than prescribed. Your||
6095|072|H|condition will not improve any faster, and your risk of side||
6095|073|H|effects will increase. Take this medication regularly to get the||
6095|074|H|most benefit from it. To help you remember, take it at the same||
6095|075|H|time each day.||
6095|076|H|   If you are taking paroxetine for premenstrual problems, your||
6095|077|H|doctor may direct you to take it every day of the month or just||
6095|078|H|for the 2 weeks before your period through the first full day of||
6095|079|H|your period.||
6095|080|H|   Keep taking this medication even if you feel well. Do not stop||
6095|081|H|taking this medication without consulting your doctor. Some||
6095|082|H|conditions may become worse when this drug is suddenly stopped.||
6095|083|H|Also, you may experience symptoms such as mood swings, headache,||
6095|084|H|tiredness, sleep changes, and brief feelings similar to electric||
6095|085|H|shock. To prevent these symptoms while you are stopping treatment||
6095|086|H|with this drug, your doctor may reduce your dose gradually.||
6095|087|H|Consult your doctor or pharmacist for more details. Report any||
6095|088|H|new or worsening symptoms right away.||
6095|089|H|   It may take up to several weeks before you feel the full||
6095|090|H|benefit of this drug.||
6095|091|H|   Tell your doctor if your condition does not get better or if||
6095|092|H|it gets worse.||
6095|093|B|||
6095|094|S|SIDE EFFECTS:  See also Warning section.||
6095|095|S|   Nausea, drowsiness, dizziness, trouble sleeping, loss of||
6095|096|S|appetite, weakness, dry mouth, sweating, blurred vision, and||
6095|097|S|yawning may occur. If any of these effects last or get worse,||
6095|098|S|tell your doctor or pharmacist promptly.||
6095|099|S|   Remember that this medication has been prescribed because your||
6095|100|S|doctor has judged that the benefit to you is greater than the||
6095|101|S|risk of side effects. Many people using this medication do not||
6095|102|S|have serious side effects.||
6095|103|S|   Tell your doctor right away if you have any serious side||
6095|104|S|effects, including: shaking (tremor), restlessness, inability to||
6095|105|S|keep still, decreased interest in sex, changes in sexual ability,||
6095|106|S|numbness/tingling, easy bleeding/bruising, fast/irregular||
6095|107|S|heartbeat, muscle weakness/spasm, seizures.||
6095|108|S|   Get medical help right away if you have any very serious side||
6095|109|S|effects, including: black stools, vomit that looks like coffee||
6095|110|S|grounds, eye pain/swelling/redness, widened pupils, vision||
6095|111|S|changes (such as seeing rainbows around lights at night).||
6095|112|S|   This medication may increase serotonin and rarely cause a very||
6095|113|S|serious condition called serotonin syndrome/toxicity. The risk||
6095|114|S|increases if you are also taking other drugs that increase||
6095|115|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
6095|116|S|take (see Drug Interactions section). Get medical help right away||
6095|117|S|if you develop some of the following symptoms: fast heartbeat,||
6095|118|S|hallucinations, loss of coordination, severe dizziness, severe||
6095|119|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
6095|120|S|unusual agitation/restlessness.||
6095|121|S|   Rarely, males may have a painful or prolonged erection lasting||
6095|122|S|4 or more hours. If this occurs, stop using this drug and get||
6095|123|S|medical help right away, or permanent problems could occur.||
6095|124|S|   A very serious allergic reaction to this drug is rare.||
6095|125|S|However, get medical help right away if you notice any symptoms||
6095|126|S|of a serious allergic reaction, including: rash, itching/swelling||
6095|127|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6095|128|S|breathing.||
6095|129|S|   This is not a complete list of possible side effects. If you||
6095|130|S|notice other effects not listed above, contact your doctor or||
6095|131|S|pharmacist.||
6095|132|S|   In the US -||
6095|133|S|   Call your doctor for medical advice about side effects. You||
6095|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6095|135|S|www.fda.gov/medwatch.||
6095|136|S|   In Canada - Call your doctor for medical advice about side||
6095|137|S|effects. You may report side effects to Health Canada at||
6095|138|S|1-866-234-2345.||
6095|139|B|||
6095|140|P|PRECAUTIONS:  Before taking paroxetine, tell your doctor or||
6095|141|P|pharmacist if you are allergic to it; or if you have any other||
6095|142|P|allergies. This product may contain inactive ingredients, which||
6095|143|P|can cause allergic reactions or other problems. Talk to your||
6095|144|P|pharmacist for more details.||
6095|145|P|   Before using this medication, tell your doctor or pharmacist||
6095|146|P|your medical history, especially of: personal or family history||
6095|147|P|of bipolar/manic-depressive disorder, personal or family history||
6095|148|P|of suicide attempts, liver problems, kidney problems, low sodium||
6095|149|P|in the blood, seizures, bleeding problems, personal or family||
6095|150|P|history of glaucoma (angle-closure type).||
6095|151|P|   This drug may make you dizzy or drowsy or blur your vision.||
6095|152|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
6095|153|P|drowsy. Do not drive, use machinery, or do anything that needs||
6095|154|P|alertness or clear vision until you can do it safely. Avoid||
6095|155|P|alcoholic beverages. Talk to your doctor if you are using||
6095|156|P|marijuana (cannabis).||
6095|157|P|   Before having surgery, tell your doctor or dentist about all||
6095|158|P|the products you use (including prescription drugs,||
6095|159|P|nonprescription drugs, and herbal products).||
6095|160|P|   Older adults may be more sensitive to the side effects of this||
6095|161|P|drug, especially bleeding or loss of coordination. Older adults||
6095|162|P|may also be more likely to develop a type of salt imbalance||
6095|163|P|(hyponatremia), especially if they are also taking "water pills"||
6095|164|P|(diuretics). Loss of coordination can increase the risk of||
6095|165|P|falling.||
6095|166|P|   Children may be more sensitive to the side effects of this||
6095|167|P|drug, especially loss of appetite and weight loss. Monitor weight||
6095|168|P|and height in children who are taking this drug.||
6095|169|P|   This medication is not recommended for use during pregnancy.||
6095|170|P|It may harm an unborn baby, and babies born to mothers who have||
6095|171|P|used it during the last 3 months of pregnancy may sometimes||
6095|172|P|develop withdrawal symptoms such as feeding/breathing||
6095|173|P|difficulties, seizures, muscle stiffness, or constant crying.||
6095|174|P|However, since untreated mental/mood problems (such as||
6095|175|P|depression, panic attack, obsessive-compulsive disorder, and||
6095|176|P|anxiety) can harm a pregnant woman and her unborn baby, do not||
6095|177|P|stop taking this medication unless directed by your doctor.||
6095|178|P|Instead, ask your doctor if a different medication would be right||
6095|179|P|for you. If you are planning pregnancy, become pregnant, or think||
6095|180|P|you may be pregnant, tell your doctor right away.||
6095|181|P|   This drug passes into breast milk. Consult your doctor before||
6095|182|P|breastfeeding.||
6095|183|B|||
6095|184|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6095|185|I|medications work or increase your risk for serious side effects.||
6095|186|I|This document does not contain all possible drug interactions.||
6095|187|I|Keep a list of all the products you use (including||
6095|188|I|prescription/nonprescription drugs and herbal products) and share||
6095|189|I|it with your doctor and pharmacist. Do not start, stop, or change||
6095|190|I|the dosage of any medicines without your doctor's approval.||
6095|191|I|   Some products that may interact with this drug are:||
6095|192|I|thioridazine, other drugs that can cause bleeding/bruising||
6095|193|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
6095|194|I|ibuprofen/naproxen, "blood thinners" such as||
6095|195|I|dabigatran/warfarin).||
6095|196|I|   Aspirin can increase the risk of bleeding when used with this||
6095|197|I|medication. However, if your doctor has told you to take low-dose||
6095|198|I|aspirin to prevent heart attack or stroke (usually 81-162||
6095|199|I|milligrams a day), you should keep taking the aspirin unless your||
6095|200|I|doctor tells you not to. Ask your doctor or pharmacist for more||
6095|201|I|details.||
6095|202|I|   This medication can slow down the removal of other medications||
6095|203|I|from your body, which may affect how they work. Examples of||
6095|204|I|affected drugs include atomoxetine, phenothiazines, pimozide,||
6095|205|I|risperidone, tamoxifen, tetrabenazine, antiarrhythmics such as||
6095|206|I|propafenone/flecainide, TCA antidepressants such as||
6095|207|I|desipramine/amitriptyline, among others.||
6095|208|I|   Taking MAO inhibitors with this medication may cause a serious||
6095|209|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
6095|210|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
6095|211|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
6095|212|I|selegiline, tranylcypromine) during treatment with this||
6095|213|I|medication. Most MAO inhibitors should also not be taken for two||
6095|214|I|weeks before and after treatment with this medication. Ask your||
6095|215|I|doctor when to start or stop taking this medication.||
6095|216|I|   The risk of serotonin syndrome/toxicity increases if you are||
6095|217|I|also taking other drugs that increase serotonin. Examples include||
6095|218|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
6095|219|I|antidepressants (including other SSRIs such as||
6095|220|I|citalopram/fluoxetine, SNRIs such as duloxetine/venlafaxine),||
6095|221|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
6095|222|I|may be more likely when you start or increase the dose of these||
6095|223|I|drugs.||
6095|224|I|   Tell your doctor or pharmacist if you are taking other||
6095|225|I|products that cause drowsiness including alcohol, marijuana||
6095|226|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
6095|227|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
6095|228|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
6095|229|I|codeine).||
6095|230|I|   Check the labels on all your medicines (such as allergy or||
6095|231|I|cough-and-cold products) because they may contain ingredients||
6095|232|I|that cause drowsiness. Ask your pharmacist about using those||
6095|233|I|products safely.||
6095|234|I|   This medication may interfere with certain medical/lab tests||
6095|235|I|(such as brain scan for Parkinson's disease), possibly causing||
6095|236|I|false test results. Make sure lab personnel and all your doctors||
6095|237|I|know you use this drug.||
6095|238|B|||
6095|239|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6095|240|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6095|241|O|poison control center right away. US residents can call||
6095|242|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6095|243|O|Symptoms of overdose may include: irregular heartbeat, fainting,||
6095|244|O|severe dizziness, seizures.||
6095|245|B|||
6095|246|N|NOTES:  Do not share this medication with others.||
6095|247|N|   Keep all medical and lab appointments.||
6095|248|B|||
6095|249|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6095|250|D|remember. If it is near the time of the next dose, skip the||
6095|251|D|missed dose. Take your next dose at the regular time. Do not||
6095|252|D|double the dose to catch up.||
6095|253|B|||
6095|254|R|STORAGE:  Store at room temperature. Keep all medications away||
6095|255|R|from children and pets.||
6095|256|R|   Do not flush medications down the toilet or pour them into a||
6095|257|R|drain unless instructed to do so. Properly discard this product||
6095|258|R|when it is expired or no longer needed. Consult your pharmacist||
6095|259|R|or local waste disposal company.||
6095|260|B|||
6095|261|A|Information last revised February 2025.||
6095|262|A|Copyright(c) 2025 First Databank, Inc.||
6095|263|B|||
6099|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6099|002|Z|does NOT have all possible information about this product. This||
6099|003|Z|information does not assure that this product is safe, effective,||
6099|004|Z|or appropriate for you. This information is not individual||
6099|005|Z|medical advice and does not substitute for the advice of your||
6099|006|Z|health care professional. Always ask your health care||
6099|007|Z|professional for complete information about this product and your||
6099|008|Z|specific health needs.||
6099|009|B|||
6099|010|T|CYCLOPENTOLATE SOLUTION - OPHTHALMIC||
6099|011|F|(SYE-kloe-PEN-toe-late)||
6099|012|B|||
6099|013|C|COMMON BRAND NAME(S): Cyclogyl||
6099|014|B|||
6099|015|U|USES:  This medication is used before eye examinations (such as||
6099|016|U|refraction exams). It belongs to a class of drugs known as||
6099|017|U|anticholinergics. Cyclopentolate works by temporarily widening||
6099|018|U|(dilating) the pupil of the eye and relaxing the muscles of the||
6099|019|U|eye.||
6099|020|B|||
6099|021|H|HOW TO USE:  Use this medication in the eye as directed by your||
6099|022|H|doctor, usually 40 to 50 minutes before the procedure. The dose||
6099|023|H|may need to be repeated in 5 to 10 minutes. This medication is||
6099|024|H|for use in the eye only. Do not take by mouth or inject.||
6099|025|H|   To apply eye drops, wash your hands first. To avoid||
6099|026|H|contamination, do not touch the dropper tip or let it touch your||
6099|027|H|eye or any other surface. If you are wearing contact lenses,||
6099|028|H|remove them before using eye drops. Ask your doctor when you can||
6099|029|H|start wearing them again. If you are using another kind of eye||
6099|030|H|medication (such as drops or ointments), ask your doctor when you||
6099|031|H|should start using them again.||
6099|032|H|   Tilt your head back, look upward, and pull down the lower||
6099|033|H|eyelid to make a pouch. Hold the dropper directly over your eye||
6099|034|H|and place 1 drop into the pouch. Look downward and gently close||
6099|035|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
6099|036|H|your eye (near the nose) and apply gentle pressure for 2 to 3||
6099|037|H|minutes. This will prevent the medication from draining away from||
6099|038|H|the eye and reduce side effects. Try not to blink and do not rub||
6099|039|H|your eye. Repeat these steps if your dose is for more than 1 drop||
6099|040|H|or for your other eye if so directed.||
6099|041|H|   Do not rinse the dropper. Replace cap after use.||
6099|042|H|   If you are using this medicine in a child's eye(s), do not get||
6099|043|H|any medicine in the child's mouth. Wash your hands and your||
6099|044|H|child's hands after use to remove any medicine from them.||
6099|045|H|   This medication may temporarily change digestion in infants.||
6099|046|H|Do not feed an infant for 4 hours after the infant's eye exam.||
6099|047|H|   This medication starts to work in minutes, and its effect||
6099|048|H|usually lasts 24 hours or sometimes longer. Tell your doctor if||
6099|049|H|you continue to have blurred vision, sensitivity to light, or||
6099|050|H|dilated pupils several days after your exam.||
6099|051|B|||
6099|052|S|SIDE EFFECTS:  Burning/stinging/redness of the eye, eye||
6099|053|S|irritation, or temporary blurred vision may occur. If any of||
6099|054|S|these effects last or get worse, tell your doctor or pharmacist||
6099|055|S|promptly.||
6099|056|S|   Remember that this medication has been prescribed because your||
6099|057|S|doctor has judged that the benefit to you is greater than the||
6099|058|S|risk of side effects. Many people using this medication do not||
6099|059|S|have serious side effects.||
6099|060|S|   Tell your doctor right away if you have any serious side||
6099|061|S|effects, including: dizziness, fainting, mental/mood changes||
6099|062|S|(such as confusion, hallucinations, restlessness, strange||
6099|063|S|behavior).||
6099|064|S|   Get medical help right away if you have any very serious side||
6099|065|S|effects, including: eye pain/swelling, vision changes (such as||
6099|066|S|seeing rainbows around lights at night), slow/shallow breathing,||
6099|067|S|fast/irregular heartbeat, seizures.||
6099|068|S|   A very serious allergic reaction to this drug is rare.||
6099|069|S|However, get medical help right away if you notice any symptoms||
6099|070|S|of a serious allergic reaction, including: rash, itching/swelling||
6099|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6099|072|S|breathing.||
6099|073|S|   This is not a complete list of possible side effects. If you||
6099|074|S|notice other effects not listed above, contact your doctor or||
6099|075|S|pharmacist.||
6099|076|S|   In the US -||
6099|077|S|   Call your doctor for medical advice about side effects. You||
6099|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6099|079|S|www.fda.gov/medwatch.||
6099|080|S|   In Canada - Call your doctor for medical advice about side||
6099|081|S|effects. You may report side effects to Health Canada at||
6099|082|S|1-866-234-2345.||
6099|083|B|||
6099|084|P|PRECAUTIONS:  Before using cyclopentolate, tell your doctor or||
6099|085|P|pharmacist if you are allergic to it; or to belladonna alkaloids||
6099|086|P|(such as atropine); or if you have any other allergies. This||
6099|087|P|product may contain inactive ingredients (such as preservatives||
6099|088|P|like benzalkonium chloride), which can cause allergic reactions||
6099|089|P|or other problems. Talk to your pharmacist for more details.||
6099|090|P|   Before using this medication, tell your doctor or pharmacist||
6099|091|P|your medical history, especially of: personal or family history||
6099|092|P|of glaucoma (angle-closure type), Down's syndrome, brain damage||
6099|093|P|or spastic paralysis (in children), heart disease.||
6099|094|P|   After you apply this drug, your vision may become temporarily||
6099|095|P|blurred. Do not drive, use machinery, or do anything that needs||
6099|096|P|clear vision until you can do it safely.||
6099|097|P|   This medication may make your eyes more sensitive to light.||
6099|098|P|Protect your eyes in bright light. Use dark sunglasses when||
6099|099|P|outdoors.||
6099|100|P|   Infants or small children may be more sensitive to the side||
6099|101|P|effects of this drug, especially mental/mood changes. If using||
6099|102|P|this medication in an infant, watch the infant closely for 30||
6099|103|P|minutes after the medication is applied.||
6099|104|P|   Older adults may be more sensitive to side effects of this||
6099|105|P|drug, especially increased pressure in the eye.||
6099|106|P|   During pregnancy, this medication should be used only when||
6099|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
6099|108|P|   It is unknown if this drug passes into breast milk. Consult||
6099|109|P|your doctor before breastfeeding.||
6099|110|B|||
6099|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6099|112|I|medications work or increase your risk for serious side effects.||
6099|113|I|This document does not contain all possible drug interactions.||
6099|114|I|Keep a list of all the products you use (including||
6099|115|I|prescription/nonprescription drugs and herbal products) and share||
6099|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
6099|117|I|the dosage of any medicines without your doctor's approval.||
6099|118|B|||
6099|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6099|120|O|has overdosed and has serious symptoms such as passing out or||
6099|121|O|trouble breathing, call 911. Otherwise, call a poison control||
6099|122|O|center right away. US residents can call 1-800-222-1222. Canada||
6099|123|O|residents can call 1-844-764-7669. Symptoms of overdose may||
6099|124|O|include: flushed/dry skin, blurred vision, fast/irregular||
6099|125|O|heartbeat, fever, mental/mood changes (such as hallucinations),||
6099|126|O|loss of coordination.||
6099|127|B|||
6099|128|N|NOTES:  Do not share this medication with others.||
6099|129|B|||
6099|130|D|MISSED DOSE:  Not applicable.||
6099|131|B|||
6099|132|R|STORAGE:  Store at room temperature. Do not freeze. If you are||
6099|133|R|using the single-use containers, discard any unused medication||
6099|134|R|immediately after use. Keep all medications away from children||
6099|135|R|and pets.||
6099|136|R|   Do not flush medications down the toilet or pour them into a||
6099|137|R|drain unless instructed to do so. Properly discard this product||
6099|138|R|when it is expired or no longer needed. Consult your pharmacist||
6099|139|R|or local waste disposal company.||
6099|140|B|||
6099|141|A|Information last revised May 2024.||
6099|142|A|Copyright(c) 2025 First Databank, Inc.||
6099|143|B|||
6105|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6105|002|Z|does NOT have all possible information about this product. This||
6105|003|Z|information does not assure that this product is safe, effective,||
6105|004|Z|or appropriate for you. This information is not individual||
6105|005|Z|medical advice and does not substitute for the advice of your||
6105|006|Z|health care professional. Always ask your health care||
6105|007|Z|professional for complete information about this product and your||
6105|008|Z|specific health needs.||
6105|009|B|||
6105|010|T|TIZANIDINE - ORAL||
6105|011|F|(tye-ZAN-i-deen)||
6105|012|B|||
6105|013|C|COMMON BRAND NAME(S): Zanaflex||
6105|014|B|||
6105|015|U|USES:  This medication is used to treat muscle spasms caused by||
6105|016|U|certain conditions (such as multiple sclerosis, spinal cord||
6105|017|U|injury). It works by helping to relax the muscles.||
6105|018|B|||
6105|019|H|HOW TO USE:  Take this medication by mouth as directed by your||
6105|020|H|doctor, usually every 6 to 8 hours.||
6105|021|H|   The dosage is based on your medical condition, response to||
6105|022|H|treatment, and other medications you may be taking. Be sure to||
6105|023|H|tell your doctor and pharmacist about all the products you use||
6105|024|H|(including prescription drugs, nonprescription drugs, and herbal||
6105|025|H|products). To reduce your risk of side effects, your doctor may||
6105|026|H|direct you to start this medication at a low dose and gradually||
6105|027|H|increase your dose. Follow your doctor's instructions carefully.||
6105|028|H|Do not take more than 36 milligrams a day or more than 3 doses in||
6105|029|H|a 24-hour period.||
6105|030|H|   Your body will absorb this medication differently depending on||
6105|031|H|whether you take it as a tablet or capsule, whether you take it||
6105|032|H|with food or on an empty stomach, or if you sprinkle the contents||
6105|033|H|of the capsule on food. Be sure to discuss with your doctor how||
6105|034|H|to take this medication to determine the best way to take your||
6105|035|H|dose, especially when changes to your dose are being considered||
6105|036|H|or if your doctor prescribes a different form of tizanidine (such||
6105|037|H|as tablet or capsule).||
6105|038|H|   If you suddenly stop using this medication, you may have||
6105|039|H|withdrawal symptoms (such as anxiety, tremor, increased blood||
6105|040|H|pressure/heart rate/muscle tenseness). To help prevent||
6105|041|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
6105|042|H|more likely if you have used tizanidine for a long time or in||
6105|043|H|high doses. Tell your doctor or pharmacist right away if you have||
6105|044|H|withdrawal.||
6105|045|H|   Tell your doctor if your condition does not get better or if||
6105|046|H|it gets worse.||
6105|047|B|||
6105|048|S|SIDE EFFECTS:  Dry mouth, drowsiness, dizziness, lightheadedness,||
6105|049|S|constipation, weakness, and tiredness may occur. If any of these||
6105|050|S|effects last or get worse, tell your doctor or pharmacist||
6105|051|S|promptly.||
6105|052|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
6105|053|S|chips, chew (sugarless) gum, drink water, or use a saliva||
6105|054|S|substitute.||
6105|055|S|   To reduce the risk of dizziness and lightheadedness, get up||
6105|056|S|slowly when rising from a sitting or lying position.||
6105|057|S|   Remember that this medication has been prescribed because your||
6105|058|S|doctor has judged that the benefit to you is greater than the||
6105|059|S|risk of side effects. Many people using this medication do not||
6105|060|S|have serious side effects.||
6105|061|S|   Tell your doctor right away if you have any serious side||
6105|062|S|effects, including: fainting, mental/mood changes (such as||
6105|063|S|hallucinations), slow/irregular heartbeat, vision changes (such||
6105|064|S|as blurred vision).||
6105|065|S|   Tizanidine has rarely caused very serious (rarely fatal) liver||
6105|066|S|disease. Tell your doctor right away if you develop symptoms of||
6105|067|S|liver disease, including: nausea/vomiting that doesn't stop,||
6105|068|S|severe stomach/abdominal pain, dark urine, yellowing eyes/skin.||
6105|069|S|   A very serious allergic reaction to this drug is rare.||
6105|070|S|However, get medical help right away if you notice any symptoms||
6105|071|S|of a serious allergic reaction, including: rash, itching/swelling||
6105|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6105|073|S|breathing.||
6105|074|S|   This is not a complete list of possible side effects. If you||
6105|075|S|notice other effects not listed above, contact your doctor or||
6105|076|S|pharmacist.||
6105|077|S|   In the US -||
6105|078|S|   Call your doctor for medical advice about side effects. You||
6105|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6105|080|S|www.fda.gov/medwatch.||
6105|081|S|   In Canada - Call your doctor for medical advice about side||
6105|082|S|effects. You may report side effects to Health Canada at||
6105|083|S|1-866-234-2345.||
6105|084|B|||
6105|085|P|PRECAUTIONS:  Before taking tizanidine, tell your doctor or||
6105|086|P|pharmacist if you are allergic to it; or if you have any other||
6105|087|P|allergies. This product may contain inactive ingredients, which||
6105|088|P|can cause allergic reactions or other problems. Talk to your||
6105|089|P|pharmacist for more details.||
6105|090|P|   Before using this medication, tell your doctor or pharmacist||
6105|091|P|your medical history, especially of: low blood pressure, kidney||
6105|092|P|disease, liver disease.||
6105|093|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6105|094|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6105|095|P|machinery, or do anything that needs alertness until you can do||
6105|096|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6105|097|P|are using marijuana (cannabis).||
6105|098|P|   Before having surgery, tell your doctor or dentist about all||
6105|099|P|the products you use (including prescription drugs,||
6105|100|P|nonprescription drugs, and herbal products).||
6105|101|P|   Older adults may be more sensitive to the side effects of this||
6105|102|P|drug, especially dizziness and drowsiness. These effects can||
6105|103|P|increase the risk of falling.||
6105|104|P|   During pregnancy, this medication should be used only when||
6105|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
6105|106|P|   It is unknown if this drug passes into breast milk. Consult||
6105|107|P|your doctor before breastfeeding.||
6105|108|B|||
6105|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6105|110|I|medications work or increase your risk for serious side effects.||
6105|111|I|This document does not contain all possible drug interactions.||
6105|112|I|Keep a list of all the products you use (including||
6105|113|I|prescription/nonprescription drugs and herbal products) and share||
6105|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
6105|115|I|the dosage of any medicines without your doctor's approval.||
6105|116|I|   Some products that may interact with this drug include:||
6105|117|I|certain drugs to treat high blood pressure (alpha agonists such||
6105|118|I|as clonidine, methyldopa).||
6105|119|I|   Other medications can affect the removal of tizanidine from||
6105|120|I|your body, which may affect how tizanidine works. Examples||
6105|121|I|include birth control pills, ciprofloxacin, enasidenib,||
6105|122|I|fluvoxamine, viloxazine, among others.||
6105|123|I|   Tell your doctor or pharmacist if you are taking other||
6105|124|I|products that cause drowsiness including alcohol, marijuana||
6105|125|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
6105|126|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
6105|127|I|zolpidem), other muscle relaxants, and opioid pain relievers||
6105|128|I|(such as codeine).||
6105|129|I|   Check the labels on all your medicines (such as allergy or||
6105|130|I|cough-and-cold products) because they may contain ingredients||
6105|131|I|that cause drowsiness. Ask your pharmacist about using those||
6105|132|I|products safely.||
6105|133|B|||
6105|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6105|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6105|136|O|poison control center right away. US residents can call||
6105|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6105|138|O|Symptoms of overdose may include: severe dizziness/drowsiness,||
6105|139|O|confusion, slow/shallow breathing, fainting.||
6105|140|B|||
6105|141|N|NOTES:  Do not share this medication with others.||
6105|142|N|   Lab and/or medical tests (such as blood pressure, liver||
6105|143|N|function) should be done while you are taking this medication.||
6105|144|N|Keep all medical and lab appointments. Consult your doctor for||
6105|145|N|more details.||
6105|146|B|||
6105|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6105|148|D|remember. If it is near the time of the next dose, skip the||
6105|149|D|missed dose. Take your next dose at the regular time. Do not||
6105|150|D|double the dose to catch up.||
6105|151|B|||
6105|152|R|STORAGE:  Store at room temperature away from light and moisture.||
6105|153|R|Do not store in the bathroom. Keep all medications away from||
6105|154|R|children and pets.||
6105|155|R|   Do not flush medications down the toilet or pour them into a||
6105|156|R|drain unless instructed to do so. Properly discard this product||
6105|157|R|when it is expired or no longer needed. Consult your pharmacist||
6105|158|R|or local waste disposal company.||
6105|159|B|||
6105|160|A|Information last revised October 2024.||
6105|161|A|Copyright(c) 2025 First Databank, Inc.||
6105|162|B|||
6106|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6106|002|Z|does NOT have all possible information about this product. This||
6106|003|Z|information does not assure that this product is safe, effective,||
6106|004|Z|or appropriate for you. This information is not individual||
6106|005|Z|medical advice and does not substitute for the advice of your||
6106|006|Z|health care professional. Always ask your health care||
6106|007|Z|professional for complete information about this product and your||
6106|008|Z|specific health needs.||
6106|009|B|||
6106|010|T|VITAMIN B COMPLEX - ORAL||
6106|011|B|||
6106|012|C|COMMON BRAND NAME(S): Nephro-vite, Nephrocaps, Triphrocaps||
6106|013|B|||
6106|014|U|USES:  This product is a combination of B vitamins used to treat||
6106|015|U|or prevent vitamin deficiency due to poor diet, certain||
6106|016|U|illnesses, alcoholism, or during pregnancy. Vitamins are||
6106|017|U|important building blocks of the body and help keep you in good||
6106|018|U|health. B vitamins include thiamine, riboflavin,||
6106|019|U|niacin/niacinamide, vitamin B6, vitamin B12, folic acid, and||
6106|020|U|pantothenic acid.||
6106|021|U|   Some brands of B vitamins also contain ingredients such as||
6106|022|U|vitamin C, vitamin E, biotin, or zinc. Consult your doctor or||
6106|023|U|pharmacist if you have questions about the ingredients in your||
6106|024|U|brand.||
6106|025|B|||
6106|026|H|HOW TO USE:  Take this medication by mouth, usually once daily or||
6106|027|H|as directed. Follow all directions on the product package. If you||
6106|028|H|have any questions, ask your doctor or pharmacist.||
6106|029|H|   If you are taking a brand that contains vitamin C, take this||
6106|030|H|medication by mouth with a full glass of water (8 ounces/240||
6106|031|H|milliliters) unless your doctor directs you otherwise.||
6106|032|H|   If you are taking chewable tablets, chew the tablet thoroughly||
6106|033|H|before swallowing.||
6106|034|H|   If you are taking extended-release capsules, swallow them||
6106|035|H|whole. Do not crush or chew extended-release capsules or tablets.||
6106|036|H|Doing so can release all of the drug at once, increasing the risk||
6106|037|H|of side effects. Swallow the whole tablet without crushing or||
6106|038|H|chewing.||
6106|039|H|   If you are taking a liquid product, use a medication-measuring||
6106|040|H|device to carefully measure the dose. Do not use a household||
6106|041|H|spoon. Some liquid products need to be shaken before each dose.||
6106|042|H|Some products that contain vitamin B12 need to be placed under||
6106|043|H|the tongue and held there before swallowing. Follow label||
6106|044|H|directions carefully to get the most benefit.||
6106|045|H|   Take this medication regularly in order to get the most||
6106|046|H|benefit from it. To help you remember, take it at the same time||
6106|047|H|each day.||
6106|048|B|||
6106|049|S|SIDE EFFECTS:  Mild upset stomach or flushing may occur. These||
6106|050|S|effects are usually temporary and may disappear as your body||
6106|051|S|adjusts to this product. If any of these effects last or get||
6106|052|S|worse, tell your doctor or pharmacist promptly.||
6106|053|S|   If your doctor has directed you to use this medication,||
6106|054|S|remember that your doctor has judged that the benefit to you is||
6106|055|S|greater than the risk of side effects. Many people using this||
6106|056|S|medication do not have serious side effects.||
6106|057|S|   A very serious allergic reaction to this drug is rare.||
6106|058|S|However, get medical help right away if you notice any symptoms||
6106|059|S|of a serious allergic reaction, including: rash, itching/swelling||
6106|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6106|061|S|breathing.||
6106|062|S|   This is not a complete list of possible side effects. If you||
6106|063|S|notice other effects not listed above, contact your doctor or||
6106|064|S|pharmacist.||
6106|065|S|   In the US -||
6106|066|S|   Call your doctor for medical advice about side effects. You||
6106|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6106|068|S|www.fda.gov/medwatch.||
6106|069|S|   In Canada - Call your doctor for medical advice about side||
6106|070|S|effects. You may report side effects to Health Canada at||
6106|071|S|1-866-234-2345.||
6106|072|B|||
6106|073|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
6106|074|P|pharmacist if you are allergic to any of its ingredients; or if||
6106|075|P|you have any other allergies. This product may contain inactive||
6106|076|P|ingredients, which can cause allergic reactions or other||
6106|077|P|problems. Talk to your pharmacist for more details.||
6106|078|P|   If you have any of the following health problems, consult your||
6106|079|P|doctor or pharmacist before using this product: diabetes, liver||
6106|080|P|problems, vitamin B12 deficiency (pernicious anemia).||
6106|081|P|   Chewable tablets or liquid products may contain aspartame. If||
6106|082|P|you have phenylketonuria (PKU) or any other condition that||
6106|083|P|requires you to restrict your intake of aspartame (or||
6106|084|P|phenylalanine), consult your doctor or pharmacist about using||
6106|085|P|this drug safely.||
6106|086|P|   Liquid forms of this product may contain sugar and/or alcohol.||
6106|087|P|Caution is advised if you have diabetes, alcohol dependence, or||
6106|088|P|liver disease. Ask your doctor or pharmacist about using this||
6106|089|P|product safely.||
6106|090|P|   Before having surgery, tell your doctor or dentist about all||
6106|091|P|the products you use (including prescription drugs,||
6106|092|P|nonprescription drugs, and herbal products).||
6106|093|P|   Tell your doctor if you are pregnant before using this||
6106|094|P|medication. This product is safe to take during pregnancy when||
6106|095|P|used as directed. Certain spinal cord birth defects may be||
6106|096|P|prevented by maintaining adequate amounts of folic acid during||
6106|097|P|pregnancy. Consult your doctor or pharmacist for details.||
6106|098|P|   This product passes into breast milk. Consult your doctor||
6106|099|P|before breastfeeding.||
6106|100|B|||
6106|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6106|102|I|medications work or increase your risk for serious side effects.||
6106|103|I|This document does not contain all possible drug interactions.||
6106|104|I|Keep a list of all the products you use (including||
6106|105|I|prescription/nonprescription drugs and herbal products) and share||
6106|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
6106|107|I|the dosage of any medicines without your doctor's approval.||
6106|108|I|   Some products that may interact with this drug are:||
6106|109|I|altretamine, cisplatin, certain anti-seizure drugs (such as||
6106|110|I|phenytoin), levodopa, other vitamin/nutritional supplements.||
6106|111|I|   This product may interfere with certain lab tests (such as||
6106|112|I|urobilinogen, intrinsic factor antibodies), possibly causing||
6106|113|I|false test results. Make sure lab personnel and all your doctors||
6106|114|I|know you use this product.||
6106|115|B|||
6106|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6106|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6106|118|O|poison control center right away. US residents can call||
6106|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6106|120|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
6106|121|O|diarrhea.||
6106|122|B|||
6106|123|N|NOTES:  Keep all medical and lab appointments.||
6106|124|N|   This product is not a substitute for a proper diet. Remember||
6106|125|N|that it is best to get your vitamins from healthy foods. B||
6106|126|N|vitamins are naturally found in leafy greens and other||
6106|127|N|vegetables, meat, fish, poultry, and enriched breads/cereals.||
6106|128|B|||
6106|129|D|MISSED DOSE:  If you are taking this product on a regular||
6106|130|D|schedule and miss a dose, take it as soon as you remember. If it||
6106|131|D|is near the time of the next dose, skip the missed dose. Take||
6106|132|D|your next dose at the regular time. Do not double the dose to||
6106|133|D|catch up.||
6106|134|B|||
6106|135|R|STORAGE:  Refer to storage information printed on the package. If||
6106|136|R|you have any questions about storage, ask your pharmacist. Keep||
6106|137|R|all medications away from children and pets.||
6106|138|R|   Do not flush medications down the toilet or pour them into a||
6106|139|R|drain unless instructed to do so. Properly discard this product||
6106|140|R|when it is expired or no longer needed. Consult your pharmacist||
6106|141|R|or local waste disposal company.||
6106|142|B|||
6106|143|A|Information last revised February 2025.||
6106|144|A|Copyright(c) 2025 First Databank, Inc.||
6106|145|B|||
6108|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6108|002|Z|does NOT have all possible information about this product. This||
6108|003|Z|information does not assure that this product is safe, effective,||
6108|004|Z|or appropriate for you. This information is not individual||
6108|005|Z|medical advice and does not substitute for the advice of your||
6108|006|Z|health care professional. Always ask your health care||
6108|007|Z|professional for complete information about this product and your||
6108|008|Z|specific health needs.||
6108|009|B|||
6108|010|T|TACROLIMUS - ORAL||
6108|011|F|(ta-KROE-li-mus)||
6108|012|B|||
6108|013|C|COMMON BRAND NAME(S): Prograf||
6108|014|B|||
6108|015|W|WARNING:  Tacrolimus lowers the body's ability to fight an||
6108|016|W|infection/disease (immunosuppression). This may increase your||
6108|017|W|risk of developing an infection or certain types of cancer (such||
6108|018|W|as skin cancer, lymphoma). To reduce the risk of these serious||
6108|019|W|side effects, take this medication at the lowest effective dose||
6108|020|W|as directed by your doctor. Keep all medical and lab||
6108|021|W|appointments.||
6108|022|W|   Tell your doctor right away if you develop any of the||
6108|023|W|following: unusual skin changes, change in the appearance/size of||
6108|024|W|moles, unusual growths/lumps, swollen lymph nodes, night sweats,||
6108|025|W|unexplained weight loss, signs of infection (such as sore throat||
6108|026|W|that doesn't go away, fever, chills).||
6108|027|B|||
6108|028|U|USES:  Tacrolimus is used with other medications to prevent||
6108|029|U|rejection of a kidney, heart, liver, or lung transplant. This||
6108|030|U|medication belongs to a class of drugs known as||
6108|031|U|immunosuppressants. It works by weakening your body's defense||
6108|032|U|system (immune system) to help your body accept the new organ as||
6108|033|U|if it were your own.||
6108|034|B|||
6108|035|V|OTHER USES:  This section contains uses of this drug that are not||
6108|036|V|listed in the approved professional labeling for the drug but||
6108|037|V|that may be prescribed by your health care professional. Use this||
6108|038|V|drug for a condition that is listed in this section only if it||
6108|039|V|has been so prescribed by your health care professional.||
6108|040|V|   This drug may also be used for a certain type of bowel||
6108|041|V|condition (fistulizing Crohn's disease) in people who cannot take||
6108|042|V|or have not been successfully treated by the usual treatment.||
6108|043|B|||
6108|044|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6108|045|H|from your pharmacist before you start taking tacrolimus and each||
6108|046|H|time you get a refill. If you have any questions, ask your doctor||
6108|047|H|or pharmacist.||
6108|048|H|   Take this medication by mouth with or without food as directed||
6108|049|H|by your doctor, usually every 12 hours. If you have nausea or an||
6108|050|H|upset stomach, you may take this drug with food, although this||
6108|051|H|may cause your body to absorb less of the drug. However, you must||
6108|052|H|choose one way (with food or without food) and always take this||
6108|053|H|medication the same way so that your body always absorbs the same||
6108|054|H|amount of drug. Consult your doctor or pharmacist for more||
6108|055|H|details.||
6108|056|H|   If you are taking the capsules, swallow them whole. Do not||
6108|057|H|open or crush the capsules.||
6108|058|H|   If you are using the granules, read the manufacturer's||
6108|059|H|Instructions for Use first. Use only non-plastic cups, spoons, or||
6108|060|H|oral syringes when preparing or taking a dose. Do not sprinkle||
6108|061|H|the granules on food. Open up the prescribed number of packets||
6108|062|H|for your dose and mix the granules in a cup with 1 to 2||
6108|063|H|tablespoons (15 to 30 milliliters) of room temperature water and||
6108|064|H|stir well. Drink the dose immediately. You may use an oral||
6108|065|H|syringe to give the dose. Rinse the cup or syringe with the same||
6108|066|H|amount of water and drink the rinse water to make sure the||
6108|067|H|complete dose is taken. Do not prepare the granule mixture ahead||
6108|068|H|of time. Do not save any of the mixture for later use.||
6108|069|H|   The dosage is based on your weight, medical condition, lab||
6108|070|H|tests (such as tacrolimus trough levels), and response to||
6108|071|H|treatment.||
6108|072|H|   Tacrolimus is available in different formulations (such as||
6108|073|H|immediate and extended-release). Do not switch between different||
6108|074|H|forms of tacrolimus without consulting your doctor.||
6108|075|H|   Do not increase your dose or take this medication more often||
6108|076|H|without your doctor's approval. Your condition will not improve||
6108|077|H|any faster and the risk of serious side effects may be increased.||
6108|078|H|Also, do not stop taking this medication without your doctor's||
6108|079|H|approval.||
6108|080|H|   Take this medication regularly in order to get the most||
6108|081|H|benefit from it. It is important to take all doses on time to||
6108|082|H|keep the amount of medicine in your body at a constant level.||
6108|083|H|Remember to take it at the same times each day.||
6108|084|H|   Avoid eating grapefruit or drinking grapefruit juice while||
6108|085|H|using this medication unless your doctor or pharmacist says you||
6108|086|H|may do so safely. Grapefruit can increase the chance of side||
6108|087|H|effects with this medicine. Ask your doctor or pharmacist for||
6108|088|H|more details.||
6108|089|H|   Since this drug can be absorbed through the skin and lungs and||
6108|090|H|may harm an unborn baby, women who are pregnant or who may become||
6108|091|H|pregnant should not handle this medication or breathe the dust||
6108|092|H|from the capsules.||
6108|093|H|   Tell your doctor if your condition gets worse.||
6108|094|B|||
6108|095|S|SIDE EFFECTS:  See also Warning section.||
6108|096|S|   Shaking, headache, diarrhea, nausea/vomiting, upset stomach,||
6108|097|S|loss of appetite, trouble sleeping, and numbness/tingling of the||
6108|098|S|hands/feet may occur. If any of these effects last or get worse,||
6108|099|S|tell your doctor or pharmacist promptly.||
6108|100|S|   Remember that this medication has been prescribed because your||
6108|101|S|doctor has judged that the benefit to you is greater than the||
6108|102|S|risk of side effects. Many people using this medication do not||
6108|103|S|have serious side effects.||
6108|104|S|   Tell your doctor right away if you have any serious side||
6108|105|S|effects, including: mental/mood changes, dizziness, signs of||
6108|106|S|kidney problems (such as change in the amount of urine), pounding||
6108|107|S|heartbeat, symptoms of heart failure (such as shortness of||
6108|108|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
6108|109|S|weight gain), hearing problems (such as hearing loss, ringing in||
6108|110|S|the ears), pain/redness/swelling of arms or legs, easy||
6108|111|S|bruising/bleeding, muscle pain/cramp/weakness, signs of liver||
6108|112|S|problems (such as nausea/vomiting that doesn't stop, yellowing||
6108|113|S|eyes/skin, dark urine, stomach/abdominal pain), severe leg pain.||
6108|114|S|   This medication may also increase your risk of getting a rare||
6108|115|S|but very serious (sometimes fatal) brain infection (progressive||
6108|116|S|multifocal leukoencephalopathy-PML). Get medical help right away||
6108|117|S|if any of these rare but very serious side effects occur:||
6108|118|S|clumsiness, loss of coordination, weakness, sudden change in your||
6108|119|S|thinking (such as confusion, difficulty concentrating),||
6108|120|S|difficulty moving your muscles, problems with speech, seizure,||
6108|121|S|vision changes.||
6108|122|S|   Get medical help right away if you have any very serious side||
6108|123|S|effects, including: fainting, fast/irregular heartbeat, severe||
6108|124|S|dizziness, chest/jaw/left arm pain, black stools, vomit that||
6108|125|S|looks like coffee grounds.||
6108|126|S|   This medication may raise your blood pressure. Check your||
6108|127|S|blood pressure regularly and tell your doctor if the results are||
6108|128|S|high. Your doctor may control your blood pressure with||
6108|129|S|medication.||
6108|130|S|   Tacrolimus may cause diabetes. Tell your doctor or pharmacist||
6108|131|S|if you experience any of the following symptoms of high blood||
6108|132|S|sugar: increased thirst/hunger, frequent urination.||
6108|133|S|   A very serious allergic reaction to this drug is rare.||
6108|134|S|However, get medical help right away if you notice any symptoms||
6108|135|S|of a serious allergic reaction, including: rash, itching/swelling||
6108|136|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6108|137|S|breathing.||
6108|138|S|   This is not a complete list of possible side effects. If you||
6108|139|S|notice other effects not listed above, contact your doctor or||
6108|140|S|pharmacist.||
6108|141|S|   In the US -||
6108|142|S|   Call your doctor for medical advice about side effects. You||
6108|143|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6108|144|S|www.fda.gov/medwatch.||
6108|145|S|   In Canada - Call your doctor for medical advice about side||
6108|146|S|effects. You may report side effects to Health Canada at||
6108|147|S|1-866-234-2345.||
6108|148|B|||
6108|149|P|PRECAUTIONS:  Before taking tacrolimus, tell your doctor or||
6108|150|P|pharmacist if you are allergic to it; or to other macrolide||
6108|151|P|medications (such as sirolimus); or if you have any other||
6108|152|P|allergies. This product may contain inactive ingredients, which||
6108|153|P|can cause allergic reactions or other problems. Talk to your||
6108|154|P|pharmacist for more details.||
6108|155|P|   Before using this medication, tell your doctor or pharmacist||
6108|156|P|your medical history, especially of: mineral imbalances (such as||
6108|157|P|high potassium), kidney disease, any recent/current infections,||
6108|158|P|cancer, liver disease, high blood pressure, diabetes.||
6108|159|P|   Tacrolimus may cause a condition that affects the heart rhythm||
6108|160|P|(QT prolongation). QT prolongation can rarely cause serious||
6108|161|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
6108|162|P|as severe dizziness, fainting) that need medical attention right||
6108|163|P|away.||
6108|164|P|   The risk of QT prolongation may be increased if you have||
6108|165|P|certain medical conditions or are taking other drugs that may||
6108|166|P|cause QT prolongation. Before using tacrolimus, tell your doctor||
6108|167|P|or pharmacist of all the drugs you take and if you have any of||
6108|168|P|the following conditions: certain heart problems (heart failure,||
6108|169|P|slow heartbeat, QT prolongation in the EKG), family history of||
6108|170|P|certain heart problems (QT prolongation in the EKG, sudden||
6108|171|P|cardiac death).||
6108|172|P|   Low levels of potassium or magnesium in the blood may also||
6108|173|P|increase your risk of QT prolongation. This risk may increase if||
6108|174|P|you use certain drugs (such as diuretics/"water pills") or if you||
6108|175|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6108|176|P|Talk to your doctor about using tacrolimus safely.||
6108|177|P|   This medication may increase your risk of developing skin||
6108|178|P|cancer. Limit your time in the sun. Avoid tanning booths and||
6108|179|P|sunlamps. Use sunscreen and wear protective clothing when||
6108|180|P|outdoors.||
6108|181|P|   Tacrolimus can make you more likely to get infections or may||
6108|182|P|make current infections worse. Stay away from anyone who has an||
6108|183|P|infection that may easily spread (such as chickenpox, COVID-19,||
6108|184|P|measles, flu). Talk to your doctor if you have been exposed to an||
6108|185|P|infection or for more details.||
6108|186|P|   Tell your health care professional that you are using||
6108|187|P|tacrolimus before having any immunizations/vaccinations. Avoid||
6108|188|P|contact with people who have recently received live vaccines||
6108|189|P|(such as flu vaccine inhaled through the nose).||
6108|190|P|   This drug may increase your potassium levels. Before using||
6108|191|P|potassium supplements or salt substitutes containing potassium,||
6108|192|P|consult your doctor or pharmacist.||
6108|193|P|   Before having surgery, tell your doctor or dentist about all||
6108|194|P|the products you use (including prescription drugs,||
6108|195|P|nonprescription drugs, and herbal products).||
6108|196|P|   Older adults may be more sensitive to the side effects of this||
6108|197|P|drug, especially QT prolongation (see above).||
6108|198|P|   Since this drug can be absorbed through the skin and lungs and||
6108|199|P|may harm an unborn baby, women who are pregnant or who may become||
6108|200|P|pregnant should not handle this medication or breathe the dust||
6108|201|P|from the capsules.||
6108|202|P|   Tell your doctor if you are pregnant or plan to become||
6108|203|P|pregnant. You should not become pregnant while using tacrolimus.||
6108|204|P|Tacrolimus may harm an unborn baby. Men and women using this||
6108|205|P|medication should ask about reliable forms of birth control||
6108|206|P|before and during treatment. If you or your partner becomes||
6108|207|P|pregnant, talk to your doctor right away about the risks and||
6108|208|P|benefits of this medication.||
6108|209|P|   This drug passes into breast milk and the effect on a nursing||
6108|210|P|infant is unknown. Consult your doctor before breastfeeding.||
6108|211|B|||
6108|212|I|DRUG INTERACTIONS:  See also How to Use section.||
6108|213|I|   Drug interactions may change how your medications work or||
6108|214|I|increase your risk for serious side effects. This document does||
6108|215|I|not contain all possible drug interactions. Keep a list of all||
6108|216|I|the products you use (including prescription/nonprescription||
6108|217|I|drugs and herbal products) and share it with your doctor and||
6108|218|I|pharmacist. Do not start, stop, or change the dosage of any||
6108|219|I|medicines without your doctor's approval.||
6108|220|I|   Some products that may interact with this drug include:||
6108|221|I|aluminum/magnesium antacid, cyclosporine, sirolimus,||
6108|222|I|temsirolimus, ziprasidone, other drugs that may increase the||
6108|223|I|level of potassium in the blood (such as "water pills" including||
6108|224|I|amiloride, spironolactone), other drugs that weaken the immune||
6108|225|I|system/increase the risk of infection (such as natalizumab,||
6108|226|I|rituximab).||
6108|227|I|   Other medications can affect the removal of tacrolimus from||
6108|228|I|your body, which may affect how tacrolimus works. Examples||
6108|229|I|include azole antifungals (such as itraconazole, voriconazole),||
6108|230|I|cimetidine, danazol, ethinyl estradiol, methylprednisolone,||
6108|231|I|nefazodone, HIV protease inhibitors (such as nelfinavir),||
6108|232|I|rifamycins (such as rifampin, rifabutin), ritonavir, St. John's||
6108|233|I|wort, certain anti-seizure drugs (such as phenobarbital,||
6108|234|I|phenytoin), among others.||
6108|235|B|||
6108|236|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6108|237|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6108|238|O|poison control center right away. US residents can call||
6108|239|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6108|240|B|||
6108|241|N|NOTES:  Lab and/or medical tests (such as potassium levels, blood||
6108|242|N|pressure, blood sugar, tacrolimus trough level, kidney/liver||
6108|243|N|function) will be done while you are taking this medication. Keep||
6108|244|N|all medical and lab appointments. Consult your doctor for more||
6108|245|N|details.||
6108|246|N|   If you have had an organ transplant, it is recommended that||
6108|247|N|you attend a transplant education class or support group. Learn||
6108|248|N|the signs of organ rejection such as a feeling of being ill,||
6108|249|N|fever, or tenderness/pain around the transplanted organ. Tell||
6108|250|N|your doctor right away if you notice any of these signs.||
6108|251|B|||
6108|252|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6108|253|D|remember. If it is near the time of the next dose, skip the||
6108|254|D|missed dose. Take your next dose at the regular time. Do not||
6108|255|D|double the dose to catch up.||
6108|256|B|||
6108|257|R|STORAGE:  Store at room temperature away from light and moisture.||
6108|258|R|Do not store in the bathroom. Keep all medications away from||
6108|259|R|children and pets.||
6108|260|R|   Do not flush medications down the toilet or pour them into a||
6108|261|R|drain unless instructed to do so. Properly discard this product||
6108|262|R|when it is expired or no longer needed. Consult your pharmacist||
6108|263|R|or local waste disposal company.||
6108|264|B|||
6108|265|M|MEDICAL ALERT:  Your condition can cause complications in a||
6108|266|M|medical emergency. For information about enrolling in MedicAlert,||
6108|267|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6108|268|B|||
6108|269|A|Information last revised May 2025.||
6108|270|A|Copyright(c) 2025 First Databank, Inc.||
6108|271|B|||
6109|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6109|002|Z|does NOT have all possible information about this product. This||
6109|003|Z|information does not assure that this product is safe, effective,||
6109|004|Z|or appropriate for you. This information is not individual||
6109|005|Z|medical advice and does not substitute for the advice of your||
6109|006|Z|health care professional. Always ask your health care||
6109|007|Z|professional for complete information about this product and your||
6109|008|Z|specific health needs.||
6109|009|B|||
6109|010|T|BULK-FORMING LAXATIVES - ORAL||
6109|011|B|||
6109|012|U|USES:  This medication is used to treat constipation. It||
6109|013|U|increases the bulk in your stool, an effect that helps to cause||
6109|014|U|movement of the intestines. It also works by increasing the||
6109|015|U|amount of water in the stool, making the stool softer and easier||
6109|016|U|to pass.||
6109|017|U|   Psyllium, one type of bulk-forming laxative, has also been||
6109|018|U|used along with a proper diet to treat high cholesterol.||
6109|019|B|||
6109|020|V|OTHER USES:  This section contains uses of this drug that are not||
6109|021|V|listed in the approved professional labeling for the drug but||
6109|022|V|that may be prescribed by your health care professional. Use this||
6109|023|V|drug for a condition that is listed in this section only if it||
6109|024|V|has been so prescribed by your health care professional.||
6109|025|V|   This drug may also be used to help relieve the symptoms of||
6109|026|V|irritable bowel syndrome.||
6109|027|B|||
6109|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
6109|029|H|doctor. If you are self-treating, follow all directions on the||
6109|030|H|product package. If you have any questions, ask your doctor or||
6109|031|H|pharmacist. To prevent choking from this medication, take it with||
6109|032|H|a full glass of water or other liquid (8 ounces/240 milliliters).||
6109|033|H|If you are taking the wafers, chew them thoroughly before||
6109|034|H|swallowing.||
6109|035|H|   For powder forms of this medication, measure each dose||
6109|036|H|according to the directions on the product label. Mix in a full||
6109|037|H|glass of water or other liquid (8 ounces/240 milliliters), stir||
6109|038|H|completely, and drink right away. You may add more liquid to the||
6109|039|H|mixture if it becomes too thick. When preparing the medication,||
6109|040|H|be careful not to breathe in the powder since it may rarely cause||
6109|041|H|an allergic reaction.||
6109|042|H|   Dosage is based on your age, medical condition, and response||
6109|043|H|to treatment. Do not increase your dose or take this drug more||
6109|044|H|often than directed.||
6109|045|H|   This product may decrease the absorption of other medications||
6109|046|H|you may be taking. Take this product at least 2 hours from your||
6109|047|H|other medications. Ask your doctor or pharmacist for more||
6109|048|H|information or if you have any questions.||
6109|049|H|   It may take 1 to 3 days before this medication starts working.||
6109|050|H|Use this medication regularly to get the most benefit from it. To||
6109|051|H|help you remember, take it at the same time(s) each day. Do not||
6109|052|H|take this medication for more than 7 days unless directed by your||
6109|053|H|doctor.||
6109|054|H|   Tell your doctor if your condition lasts or gets worse, or if||
6109|055|H|bleeding from the rectum occurs. If you think you may have a||
6109|056|H|serious medical problem, get medical help right away.||
6109|057|B|||
6109|058|S|SIDE EFFECTS:  Gas or stomach cramping may occur. If any of these||
6109|059|S|effects last or get worse, tell your doctor or pharmacist||
6109|060|S|promptly.||
6109|061|S|   If your doctor has directed you to use this product, remember||
6109|062|S|that your doctor has judged that the benefit to you is greater||
6109|063|S|than the risk of side effects. Many people using this medication||
6109|064|S|do not have serious side effects.||
6109|065|S|   This product must be taken with at least a full glass of water||
6109|066|S|or other liquid (8 ounces/240 milliliters) so that it will not||
6109|067|S|swell in the throat, causing choking. Get medical help right away||
6109|068|S|if after taking this product you have symptoms of choking such||
6109|069|S|as: chest pain, vomiting, difficulty swallowing/breathing.||
6109|070|S|   A very serious allergic reaction to this drug is rare.||
6109|071|S|However, get medical help right away if you notice any symptoms||
6109|072|S|of a serious allergic reaction, including: rash, itching/swelling||
6109|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6109|074|S|breathing.||
6109|075|S|   This is not a complete list of possible side effects. If you||
6109|076|S|notice other effects not listed above, contact your doctor or||
6109|077|S|pharmacist.||
6109|078|S|   In the US -||
6109|079|S|   Call your doctor for medical advice about side effects. You||
6109|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6109|081|S|www.fda.gov/medwatch.||
6109|082|S|   In Canada - Call your doctor for medical advice about side||
6109|083|S|effects. You may report side effects to Health Canada at||
6109|084|S|1-866-234-2345.||
6109|085|B|||
6109|086|P|PRECAUTIONS:  Before taking this bulk-forming laxative, tell your||
6109|087|P|doctor or pharmacist if you are allergic it; or if you have any||
6109|088|P|other allergies. This product may contain inactive ingredients,||
6109|089|P|which can cause allergic reactions or other problems. Talk to||
6109|090|P|your pharmacist for more details.||
6109|091|P|   Before using this medication, tell your doctor or pharmacist||
6109|092|P|your medical history, especially of: stomach/intestinal blockage,||
6109|093|P|difficulty swallowing, appendicitis or symptoms of appendicitis||
6109|094|P|(such as nausea/vomiting, sudden or unexplained stomach/abdominal||
6109|095|P|pain), a sudden change in bowel habits that lasts for longer than||
6109|096|P|2 weeks, bleeding from the rectum.||
6109|097|P|   Before having surgery, tell your doctor or dentist about all||
6109|098|P|the products you use (including prescription drugs,||
6109|099|P|nonprescription drugs, and herbal products).||
6109|100|P|   Some products may contain sugar and/or aspartame. Caution is||
6109|101|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
6109|102|P|condition that requires you to limit/avoid these substances in||
6109|103|P|your diet. Ask your doctor or pharmacist about using this product||
6109|104|P|safely.||
6109|105|P|   Tell your doctor if you are pregnant before using this||
6109|106|P|medication.||
6109|107|P|   It is unknown if this medication passes into breast milk.||
6109|108|P|Consult your doctor before breastfeeding.||
6109|109|B|||
6109|110|I|DRUG INTERACTIONS:  See also How To Use section.||
6109|111|I|   Drug interactions may change how your medications work or||
6109|112|I|increase your risk for serious side effects. This document does||
6109|113|I|not contain all possible drug interactions. Keep a list of all||
6109|114|I|the products you use (including prescription/nonprescription||
6109|115|I|drugs and herbal products) and share it with your doctor and||
6109|116|I|pharmacist. Do not start, stop, or change the dosage of any||
6109|117|I|medicines without your doctor's approval.||
6109|118|B|||
6109|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6109|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6109|121|O|poison control center right away. US residents can call||
6109|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6109|123|B|||
6109|124|N|NOTES:  Keep all medical and lab appointments.||
6109|125|N|   Lifestyle changes that may prevent or relieve constipation||
6109|126|N|include exercising, drinking enough water, and eating a proper||
6109|127|N|diet with fiber-rich foods such as bran, fresh fruits/vegetables.||
6109|128|N|Talk to your doctor or pharmacist about lifestyle changes that||
6109|129|N|might benefit you.||
6109|130|B|||
6109|131|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6109|132|D|remember. If it is near the time of the next dose, skip the||
6109|133|D|missed dose. Take your next dose at the regular time. Do not||
6109|134|D|double the dose to catch up.||
6109|135|B|||
6109|136|R|STORAGE:  Different brands of this medication have different||
6109|137|R|storage needs. Check the product package for instructions on how||
6109|138|R|to store your brand, or ask your pharmacist. Keep all medications||
6109|139|R|away from children and pets.||
6109|140|R|   Do not flush medications down the toilet or pour them into a||
6109|141|R|drain unless instructed to do so. Properly discard this product||
6109|142|R|when it is expired or no longer needed. Consult your pharmacist||
6109|143|R|or local waste disposal company.||
6109|144|B|||
6109|145|A|Information last revised May 2024.||
6109|146|A|Copyright(c) 2025 First Databank, Inc.||
6109|147|B|||
6110|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6110|002|Z|does NOT have all possible information about this product. This||
6110|003|Z|information does not assure that this product is safe, effective,||
6110|004|Z|or appropriate for you. This information is not individual||
6110|005|Z|medical advice and does not substitute for the advice of your||
6110|006|Z|health care professional. Always ask your health care||
6110|007|Z|professional for complete information about this product and your||
6110|008|Z|specific health needs.||
6110|009|B|||
6110|010|T|ZALEPLON - ORAL||
6110|011|F|(ZAL-e-plon)||
6110|012|B|||
6110|013|C|COMMON BRAND NAME(S): Sonata||
6110|014|B|||
6110|015|W|WARNING:  Rarely, after taking this drug, people have gotten out||
6110|016|W|of bed and driven vehicles while not fully awake||
6110|017|W|("sleep-driving"). People have also sleepwalked, prepared/eaten||
6110|018|W|food, made phone calls, or had sex while not fully awake. Often,||
6110|019|W|these people do not remember these events. This problem can be||
6110|020|W|dangerous (possibly fatal) to you or to others. If you find out||
6110|021|W|that you have done any of these activities after taking this||
6110|022|W|medication, tell your doctor right away. You should not take this||
6110|023|W|medication or similar medications (such as eszopiclone, zolpidem)||
6110|024|W|if you have this reaction to the medication.||
6110|025|B|||
6110|026|U|USES:  This medication is used for a short time to treat people||
6110|027|U|who have trouble falling asleep. If you have other sleep problems||
6110|028|U|such as not being able to sleep through the night, this||
6110|029|U|medication may not be right for you. Zaleplon is known as a||
6110|030|U|hypnotic. It works on certain centers in the brain to relax you||
6110|031|U|and help you fall asleep faster.||
6110|032|B|||
6110|033|H|HOW TO USE:  Read the Medication Guide provided by your||
6110|034|H|pharmacist before you start taking zaleplon and each time you get||
6110|035|H|a refill. If you have any questions, consult your doctor or||
6110|036|H|pharmacist.||
6110|037|H|   Take this medication by mouth as directed by your doctor.||
6110|038|H|Zaleplon works very quickly, so it is important to take it just||
6110|039|H|before or when you get into bed. Your doctor will work with you||
6110|040|H|to find the smallest dose that works for you.||
6110|041|H|   Zaleplon should not be used for naps. Do not take a dose of||
6110|042|H|this drug unless you have time for a full night's sleep of at||
6110|043|H|least 7 to 8 hours. If you have to wake up before that, you may||
6110|044|H|have some memory loss and may have trouble safely doing anything||
6110|045|H|that needs alertness, such as driving or operating machinery.||
6110|046|H|   You should not eat a very heavy/high-fat meal within 2 hours||
6110|047|H|before taking this medication since doing so may prevent the drug||
6110|048|H|from working properly.||
6110|049|H|   The dosage is based on your medical condition, age, and||
6110|050|H|response to treatment. Since this medication is usually||
6110|051|H|prescribed for a short time, your doctor will tell you when to||
6110|052|H|stop taking it or when to cut back.||
6110|053|H|   You may feel anxious or have trouble falling asleep in the||
6110|054|H|first day or two after stopping this medication (rebound||
6110|055|H|insomnia). Contact your doctor if you continue to have trouble||
6110|056|H|falling asleep several days after stopping zaleplon.||
6110|057|H|   If you suddenly stop using this medication, you may have||
6110|058|H|withdrawal symptoms (such as unusual depressed/anxious mood,||
6110|059|H|stomach/muscle cramps, vomiting, sweating, shakiness, or||
6110|060|H|seizures). To help prevent withdrawal, your doctor may lower your||
6110|061|H|dose slowly. Withdrawal is more likely if you have used zaleplon||
6110|062|H|for a long time (more than a few weeks) or in high doses. Tell||
6110|063|H|your doctor or pharmacist right away if you have withdrawal.||
6110|064|H|   Though it helps many people, this medication may sometimes||
6110|065|H|cause addiction. This risk may be higher if you have a substance||
6110|066|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
6110|067|H|Do not increase your dose, take it more often, or use it for a||
6110|068|H|longer time than prescribed. Properly stop the medication when so||
6110|069|H|directed.||
6110|070|H|   Tell your doctor if your condition lasts or gets worse.||
6110|071|B|||
6110|072|S|SIDE EFFECTS:  See also Warning section.||
6110|073|S|   Dizziness, drowsiness, short-term memory loss, or lack of||
6110|074|S|coordination may occur, especially during the first 2 hours after||
6110|075|S|you take the medication. Taking the medication properly just||
6110|076|S|before falling asleep will reduce your risk of these effects. If||
6110|077|S|any of these effects last or get worse, tell your doctor or||
6110|078|S|pharmacist promptly.||
6110|079|S|   To reduce the risk of dizziness and lightheadedness, get up||
6110|080|S|slowly when rising from a sitting or lying position.||
6110|081|S|   Remember that this medication has been prescribed because your||
6110|082|S|doctor has judged that the benefit to you is greater than the||
6110|083|S|risk of side effects. Many people using this medication do not||
6110|084|S|have serious side effects.||
6110|085|S|   Tell your doctor right away if you have any serious side||
6110|086|S|effects, including: mental/mood changes (such as agitation,||
6110|087|S|confusion, seeing/hearing things that are not there, rare||
6110|088|S|thoughts of suicide), unusual behavior.||
6110|089|S|   A very serious allergic reaction to this drug is rare.||
6110|090|S|However, get medical help right away if you notice any symptoms||
6110|091|S|of a serious allergic reaction, including: rash, itching/swelling||
6110|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6110|093|S|breathing.||
6110|094|S|   This is not a complete list of possible side effects. If you||
6110|095|S|notice other effects not listed above, contact your doctor or||
6110|096|S|pharmacist.||
6110|097|S|   In the US -||
6110|098|S|   Call your doctor for medical advice about side effects. You||
6110|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6110|100|S|www.fda.gov/medwatch.||
6110|101|S|   In Canada - Call your doctor for medical advice about side||
6110|102|S|effects. You may report side effects to Health Canada at||
6110|103|S|1-866-234-2345.||
6110|104|B|||
6110|105|P|PRECAUTIONS:  See also Warning section.||
6110|106|P|   Before taking zaleplon, tell your doctor or pharmacist if you||
6110|107|P|are allergic to it; or if you have any other allergies. This||
6110|108|P|product may contain inactive ingredients, which can cause||
6110|109|P|allergic reactions or other problems. Talk to your pharmacist for||
6110|110|P|more details.||
6110|111|P|   Before using this medication, tell your doctor or pharmacist||
6110|112|P|your medical history, especially of: liver problems, very||
6110|113|P|high/low blood pressure, breathing problems (such as asthma),||
6110|114|P|depression, personal or family history of a substance use||
6110|115|P|disorder (such as overuse of or addiction to drugs/alcohol).||
6110|116|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6110|117|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6110|118|P|machinery, or do anything that needs alertness until you can do||
6110|119|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6110|120|P|are using marijuana (cannabis).||
6110|121|P|   Before having surgery, tell your doctor or dentist about all||
6110|122|P|the products you use (including prescription drugs,||
6110|123|P|nonprescription drugs, and herbal products).||
6110|124|P|   Older adults may be more sensitive to the side effects of this||
6110|125|P|drug, especially memory problems, confusion, dizziness, lack of||
6110|126|P|coordination. Dizziness and lack of coordination can increase the||
6110|127|P|risk of falling.||
6110|128|P|   During pregnancy, this medication should be used only when||
6110|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
6110|130|P|   This medication passes into breast milk and may have||
6110|131|P|undesirable effects on a nursing infant. Consult your doctor||
6110|132|P|before breastfeeding.||
6110|133|B|||
6110|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6110|135|I|medications work or increase your risk for serious side effects.||
6110|136|I|This document does not contain all possible drug interactions.||
6110|137|I|Keep a list of all the products you use (including||
6110|138|I|prescription/nonprescription drugs and herbal products) and share||
6110|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
6110|140|I|the dosage of any medicines without your doctor's approval.||
6110|141|I|   Some products that may interact with this drug include:||
6110|142|I|melatonin, sodium oxybate.||
6110|143|I|   Other medications can affect the removal of zaleplon from your||
6110|144|I|body, which may affect how zaleplon works. Examples include azole||
6110|145|I|antifungals (such as ketoconazole), cimetidine, rifamycins (such||
6110|146|I|as rifabutin, rifampin), drugs used to treat seizures (such as||
6110|147|I|phenobarbital, phenytoin), among others.||
6110|148|I|   The risk of serious side effects (such as slow/shallow||
6110|149|I|breathing, severe drowsiness/dizziness) may be increased if this||
6110|150|I|medication is taken with other products that may also cause||
6110|151|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
6110|152|I|if you are taking other products such as opioid pain or cough||
6110|153|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6110|154|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
6110|155|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6110|156|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6110|157|I|diphenhydramine).||
6110|158|I|   Check the labels on all your medicines (such as allergy or||
6110|159|I|cough-and-cold products) because they may contain ingredients||
6110|160|I|that cause drowsiness. Ask your pharmacist about using those||
6110|161|I|products safely.||
6110|162|B|||
6110|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6110|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6110|165|O|poison control center right away. US residents can call||
6110|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6110|167|O|Symptoms of overdose may include confusion, loss of coordination,||
6110|168|O|slow/shallow breathing, and loss of consciousness.||
6110|169|B|||
6110|170|N|NOTES:  Do not share this medication with others. Sharing it is||
6110|171|N|against the law.||
6110|172|N|   Lifestyle changes may help improve your sleep (such as avoid||
6110|173|N|drinking beverages containing caffeine close to bedtime or taking||
6110|174|N|daytime naps). Consult your doctor or pharmacist for more||
6110|175|N|details.||
6110|176|B|||
6110|177|D|MISSED DOSE:  Not applicable.||
6110|178|B|||
6110|179|R|STORAGE:  Store at room temperature away from light and moisture.||
6110|180|R|Do not store in the bathroom. Keep all medications away from||
6110|181|R|children and pets.||
6110|182|R|   Do not flush medications down the toilet or pour them into a||
6110|183|R|drain unless instructed to do so. Properly discard this product||
6110|184|R|when it is expired or no longer needed. Consult your pharmacist||
6110|185|R|or local waste disposal company.||
6110|186|B|||
6110|187|A|Information last revised May 2024.||
6110|188|A|Copyright(c) 2025 First Databank, Inc.||
6110|189|B|||
6112|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6112|002|Z|does NOT have all possible information about this product. This||
6112|003|Z|information does not assure that this product is safe, effective,||
6112|004|Z|or appropriate for you. This information is not individual||
6112|005|Z|medical advice and does not substitute for the advice of your||
6112|006|Z|health care professional. Always ask your health care||
6112|007|Z|professional for complete information about this product and your||
6112|008|Z|specific health needs.||
6112|009|B|||
6112|010|T|DESMOPRESSIN - ORAL||
6112|011|F|(DES-moe-PRES-in)||
6112|012|B|||
6112|013|C|COMMON BRAND NAME(S): DDAVP||
6112|014|B|||
6112|015|W|WARNING:  Desmopressin can rarely cause a low level of sodium in||
6112|016|W|the blood (hyponatremia), which can be serious or even fatal.||
6112|017|W|Drinking too much liquid, using certain medications (such as||
6112|018|W|"water pills"/diuretics including furosemide, corticosteroids||
6112|019|W|such as prednisone), being 65 years or older, or having certain||
6112|020|W|medical conditions may increase the risk of low sodium in the||
6112|021|W|blood. Lab tests (such as urine tests, sodium blood levels) must||
6112|022|W|be done before you start using this medication and while you are||
6112|023|W|using it. Keep all medical and lab appointments.||
6112|024|W|   Tell your doctor right away if you develop symptoms of low||
6112|025|W|sodium in the blood, such as nausea, vomiting, headache, muscle||
6112|026|W|weakness/cramps, unusual tiredness, unusual drowsiness,||
6112|027|W|dizziness, restlessness, mental/mood changes including||
6112|028|W|confusion/irritability.||
6112|029|W|   Get medical help right away if you have any very serious side||
6112|030|W|effects, including seizure or trouble breathing.||
6112|031|B|||
6112|032|U|USES:  Desmopressin is used to control the amount of urine your||
6112|033|U|kidneys make. Normally, the amount of urine you make is||
6112|034|U|controlled by a certain substance in the body called vasopressin.||
6112|035|U|In people who have "water diabetes" (diabetes insipidus) or||
6112|036|U|certain kinds of head injury or brain surgery, the body does not||
6112|037|U|make enough vasopressin. Desmopressin is a man-made form of||
6112|038|U|vasopressin and is used to replace a low level of vasopressin.||
6112|039|U|This medication helps to control increased thirst and too much||
6112|040|U|urination due to these conditions, and helps prevent dehydration.||
6112|041|U|   Desmopressin is also used to control nighttime bedwetting in||
6112|042|U|children. It reduces how often your child urinates and decreases||
6112|043|U|the number of bedwetting episodes.||
6112|044|B|||
6112|045|H|HOW TO USE:  For the treatment of diabetes insipidus, take this||
6112|046|H|medication by mouth as directed by your doctor, usually 2 to 3||
6112|047|H|times a day.||
6112|048|H|   For the treatment of bedwetting, take this medication by mouth||
6112|049|H|as directed by your doctor, usually once a day at bedtime.||
6112|050|H|Children should limit the fluids they drink after dinner,||
6112|051|H|especially 1 hour before the desmopressin dose until the next||
6112|052|H|morning, or at least 8 hours after the dose. If your child wakes||
6112|053|H|up during the night, limit the amount that your child drinks.||
6112|054|H|   All patients taking desmopressin, especially children and||
6112|055|H|older adults, must limit drinking of water and other fluids.||
6112|056|H|Consult your doctor for details. If you find that you are||
6112|057|H|drinking more fluids than directed, tell your doctor right away.||
6112|058|H|Your treatment will need to be adjusted.||
6112|059|H|   Dosage is based on your medical condition and response to||
6112|060|H|treatment. Do not take more desmopressin or take it more often||
6112|061|H|than prescribed.||
6112|062|H|   Take this medication regularly to get the most benefit from||
6112|063|H|it. To help you remember, take it at the same time(s) each day.||
6112|064|H|   Tell your doctor if your condition does not get better or if||
6112|065|H|this medication stops working well.||
6112|066|B|||
6112|067|S|SIDE EFFECTS:  See also Warning section.||
6112|068|S|   Headache, nausea, upset stomach, or flushing of the face may||
6112|069|S|occur. If any of these effects last or get worse, tell your||
6112|070|S|doctor or pharmacist promptly.||
6112|071|S|   Remember that this medication has been prescribed because your||
6112|072|S|doctor has judged that the benefit to you is greater than the||
6112|073|S|risk of side effects. Many people using this medication do not||
6112|074|S|have serious side effects.||
6112|075|S|   A very serious allergic reaction to this drug is rare.||
6112|076|S|However, get medical help right away if you notice any symptoms||
6112|077|S|of a serious allergic reaction, including: rash, itching/swelling||
6112|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6112|079|S|breathing.||
6112|080|S|   This is not a complete list of possible side effects. If you||
6112|081|S|notice other effects not listed above, contact your doctor or||
6112|082|S|pharmacist.||
6112|083|S|   In the US -||
6112|084|S|   Call your doctor for medical advice about side effects. You||
6112|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6112|086|S|www.fda.gov/medwatch.||
6112|087|S|   In Canada - Call your doctor for medical advice about side||
6112|088|S|effects. You may report side effects to Health Canada at||
6112|089|S|1-866-234-2345.||
6112|090|B|||
6112|091|P|PRECAUTIONS:  Before taking desmopressin, tell your doctor or||
6112|092|P|pharmacist if you are allergic to it; or if you have any other||
6112|093|P|allergies. This product may contain inactive ingredients, which||
6112|094|P|can cause allergic reactions or other problems. Talk to your||
6112|095|P|pharmacist for more details.||
6112|096|P|   Before using this medication, tell your doctor or pharmacist||
6112|097|P|your medical history, especially of: kidney disease, high blood||
6112|098|P|pressure, heart problems (such as blocked blood vessels, heart||
6112|099|P|failure), conditions that may increase your risk of fluid/mineral||
6112|100|P|imbalance (such as cystic fibrosis), the urge to drink too much||
6112|101|P|water without being thirsty, a low level of sodium in the blood||
6112|102|P|(hyponatremia), bleeding/clotting problems.||
6112|103|P|   If you become dehydrated, your doctor will correct that||
6112|104|P|condition first before starting treatment with desmopressin.||
6112|105|P|   Limit alcohol because it can interfere with how well||
6112|106|P|desmopressin works.||
6112|107|P|   Tell the doctor right away if you develop any illness that can||
6112|108|P|cause water/mineral imbalance (including fever, diarrhea,||
6112|109|P|vomiting, infections such as the flu) or if you experience||
6112|110|P|conditions that require drinking more fluids (for example,||
6112|111|P|exposure to very hot weather, strenuous exercise, heavy||
6112|112|P|sweating). The doctor may need to stop or adjust desmopressin||
6112|113|P|treatment, especially in children and older adults.||
6112|114|P|   Before having surgery, tell your doctor or dentist about all||
6112|115|P|the products you use (including prescription drugs,||
6112|116|P|nonprescription drugs, and herbal products).||
6112|117|P|   Children may be more sensitive to the side effects of this||
6112|118|P|drug, especially water/mineral imbalance and a low level of||
6112|119|P|sodium in the blood.||
6112|120|P|   Older adults may be at greater risk for water/mineral||
6112|121|P|imbalance and a low level of sodium in the blood while using this||
6112|122|P|drug.||
6112|123|P|   During pregnancy, this medication should be used only when||
6112|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
6112|125|P|   This medication passes into breast milk. Consult your doctor||
6112|126|P|before breastfeeding.||
6112|127|B|||
6112|128|I|DRUG INTERACTIONS:  See also Warning section.||
6112|129|I|   Drug interactions may change how your medications work or||
6112|130|I|increase your risk for serious side effects. This document does||
6112|131|I|not contain all possible drug interactions. Keep a list of all||
6112|132|I|the products you use (including prescription/nonprescription||
6112|133|I|drugs and herbal products) and share it with your doctor and||
6112|134|I|pharmacist. Do not start, stop, or change the dosage of any||
6112|135|I|medicines without your doctor's approval.||
6112|136|I|   Some products that may interact with this drug are:||
6112|137|I|corticosteroids that are taken by mouth or inhaled (such as||
6112|138|I|fluticasone, prednisone), tolvaptan, "water pills"/diuretics||
6112|139|I|(such as furosemide).||
6112|140|B|||
6112|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6112|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6112|143|O|poison control center right away. US residents can call||
6112|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6112|145|O|Symptoms of overdose may include: headache that is severe or||
6112|146|O|doesn't go away, confusion, drowsiness, sudden weight gain.||
6112|147|B|||
6112|148|N|NOTES:  Do not share this medication with others.||
6112|149|N|   Lab and/or medical tests (such as urine tests, sodium blood||
6112|150|N|level) may be done while you are taking this medication. Keep all||
6112|151|N|medical and lab appointments. Consult your doctor for more||
6112|152|N|details.||
6112|153|B|||
6112|154|D|MISSED DOSE:  If you take 1 dose daily and miss a dose, take it||
6112|155|D|as soon as you remember. If you do not remember until the next||
6112|156|D|day, skip the missed dose. Take your next dose at the regular||
6112|157|D|time. Do not double the dose to catch up.||
6112|158|D|   If you take more than 1 dose daily and miss a dose, take it as||
6112|159|D|soon as you remember. If it is near the time of the next dose,||
6112|160|D|skip the missed dose. Take your next dose at the regular time. Do||
6112|161|D|not double the dose to catch up.||
6112|162|B|||
6112|163|R|STORAGE:  Store at room temperature away from light and moisture.||
6112|164|R|Do not store in the bathroom. Keep all medications away from||
6112|165|R|children and pets.||
6112|166|R|   Do not flush medications down the toilet or pour them into a||
6112|167|R|drain unless instructed to do so. Properly discard this product||
6112|168|R|when it is expired or no longer needed. Consult your pharmacist||
6112|169|R|or local waste disposal company.||
6112|170|B|||
6112|171|A|Information last revised November 2024.||
6112|172|A|Copyright(c) 2025 First Databank, Inc.||
6112|173|B|||
6118|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6118|002|Z|does NOT have all possible information about this product. This||
6118|003|Z|information does not assure that this product is safe, effective,||
6118|004|Z|or appropriate for you. This information is not individual||
6118|005|Z|medical advice and does not substitute for the advice of your||
6118|006|Z|health care professional. Always ask your health care||
6118|007|Z|professional for complete information about this product and your||
6118|008|Z|specific health needs.||
6118|009|B|||
6118|010|T|BENZONATATE- ORAL||
6118|011|F|(ben-ZOE-na-tate)||
6118|012|B|||
6118|013|C|COMMON BRAND NAME(S): Tessalon Perle, Zonatuss||
6118|014|B|||
6118|015|U|USES:  This medication is used to treat coughs caused by the||
6118|016|U|common cold and other breathing problems (such as pneumonia,||
6118|017|U|bronchitis, emphysema, asthma). It works by reducing the reflex||
6118|018|U|in the lungs that causes the urge to cough.||
6118|019|U|   Use of this medication is not recommended in children younger||
6118|020|U|than 10 years. Discuss the risks and benefits with your doctor.||
6118|021|B|||
6118|022|H|HOW TO USE:  Take this medication by mouth with or without food||
6118|023|H|as directed by your doctor, usually 3 times daily as needed.||
6118|024|H|   Swallow this medication whole. Do not chew, suck, or dissolve||
6118|025|H|this medication in your mouth. Doing so will cause a loss of||
6118|026|H|feeling in your mouth/throat and may cause choking or a severe||
6118|027|H|allergic reaction. (See also Side Effects section.) Do not eat or||
6118|028|H|drink until the numbness goes away. Get medical help right away||
6118|029|H|if the numbness lasts or gets worse.||
6118|030|H|   The dosage is based on your medical condition and response to||
6118|031|H|treatment. Do not take more of this drug than recommended. Doing||
6118|032|H|so will not make your cough go away faster but may result in||
6118|033|H|serious side effects.||
6118|034|H|   Tell your doctor if your condition lasts or gets worse.||
6118|035|B|||
6118|036|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, nausea, stomach||
6118|037|S|upset, constipation, and stuffy nose may occur. If any of these||
6118|038|S|effects last or get worse, tell your doctor or pharmacist||
6118|039|S|promptly.||
6118|040|S|   Remember that this medication has been prescribed because your||
6118|041|S|doctor has judged that the benefit to you is greater than the||
6118|042|S|risk of side effects. Many people using this medication do not||
6118|043|S|have serious side effects.||
6118|044|S|   Tell your doctor right away if you have any serious side||
6118|045|S|effects, including: mental/mood changes, loss of feeling in the||
6118|046|S|chest, burning in the eyes.||
6118|047|S|   A very serious allergic reaction to this drug is rare. The||
6118|048|S|possibility of an allergic reaction may increase if you chew,||
6118|049|S|suck, or dissolve this medication in your mouth. Get medical help||
6118|050|S|right away if you notice any symptoms of a serious allergic||
6118|051|S|reaction, including: rash, itching/swelling (especially of the||
6118|052|S|face/tongue/throat), severe dizziness, trouble breathing,||
6118|053|S|fainting.||
6118|054|S|   This is not a complete list of possible side effects. If you||
6118|055|S|notice other effects not listed above, contact your doctor or||
6118|056|S|pharmacist.||
6118|057|S|   In the US -||
6118|058|S|   Call your doctor for medical advice about side effects. You||
6118|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6118|060|S|www.fda.gov/medwatch.||
6118|061|S|   In Canada - Call your doctor for medical advice about side||
6118|062|S|effects. You may report side effects to Health Canada at||
6118|063|S|1-866-234-2345.||
6118|064|B|||
6118|065|P|PRECAUTIONS:  Before taking benzonatate, tell your doctor or||
6118|066|P|pharmacist if you are allergic to it; or to certain anesthetic||
6118|067|P|agents (such as procaine, tetracaine); or if you have any other||
6118|068|P|allergies. This product may contain inactive ingredients, which||
6118|069|P|can cause allergic reactions or other problems. Talk to your||
6118|070|P|pharmacist for more details.||
6118|071|P|   Before using this medication, tell your doctor or pharmacist||
6118|072|P|your medical history.||
6118|073|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6118|074|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6118|075|P|machinery, or do anything that needs alertness until you can do||
6118|076|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
6118|077|P|are using marijuana (cannabis).||
6118|078|P|   Before having surgery, tell your doctor or dentist about all||
6118|079|P|the products you use (including prescription drugs,||
6118|080|P|nonprescription drugs, and herbal products).||
6118|081|P|   During pregnancy, this medication should be used only when||
6118|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
6118|083|P|   It is unknown if this medication passes into breast milk.||
6118|084|P|Consult your doctor before breastfeeding.||
6118|085|B|||
6118|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6118|087|I|medications work or increase your risk for serious side effects.||
6118|088|I|This document does not contain all possible drug interactions.||
6118|089|I|Keep a list of all the products you use (including||
6118|090|I|prescription/nonprescription drugs and herbal products) and share||
6118|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
6118|092|I|the dosage of any medicines without your doctor's approval.||
6118|093|I|   Tell your doctor or pharmacist if you are taking other||
6118|094|I|products that cause drowsiness such as opioid pain or cough||
6118|095|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6118|096|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
6118|097|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6118|098|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6118|099|I|diphenhydramine).||
6118|100|I|   Check the labels on all your medicines (such as allergy or||
6118|101|I|cough-and-cold products) because they may contain ingredients||
6118|102|I|that cause drowsiness. Ask your pharmacist about using those||
6118|103|I|products safely.||
6118|104|B|||
6118|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6118|106|O|as passing out or trouble breathing, or if a child accidentally||
6118|107|O|swallows this medication, call 911. Otherwise, call a poison||
6118|108|O|control center right away. US residents can call 1-800-222-1222.||
6118|109|O|Canada residents can call 1-844-764-7669. Symptoms of overdose||
6118|110|O|may include: restlessness, shaking (tremors), seizures, inability||
6118|111|O|to wake up (coma).||
6118|112|B|||
6118|113|N|NOTES:  Do not share this medication with others.||
6118|114|B|||
6118|115|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
6118|116|D|next dose at the regular time. Do not double the dose to catch||
6118|117|D|up.||
6118|118|B|||
6118|119|R|STORAGE:  Store at room temperature away from light and moisture.||
6118|120|R|Do not store in the bathroom. Always store benzonatate in a||
6118|121|R|child-resistant container. Keep all medications away from||
6118|122|R|children and pets.||
6118|123|R|   Do not flush medications down the toilet or pour them into a||
6118|124|R|drain unless instructed to do so. Properly discard this product||
6118|125|R|when it is expired or no longer needed. Consult your pharmacist||
6118|126|R|or local waste disposal company.||
6118|127|B|||
6118|128|A|Information last revised May 2024.||
6118|129|A|Copyright(c) 2025 First Databank, Inc.||
6118|130|B|||
6125|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6125|002|Z|does NOT have all possible information about this product. This||
6125|003|Z|information does not assure that this product is safe, effective,||
6125|004|Z|or appropriate for you. This information is not individual||
6125|005|Z|medical advice and does not substitute for the advice of your||
6125|006|Z|health care professional. Always ask your health care||
6125|007|Z|professional for complete information about this product and your||
6125|008|Z|specific health needs.||
6125|009|B|||
6125|010|T|GENTAMICIN - TOPICAL||
6125|011|F|(JEN-ta-MYE-sin)||
6125|012|B|||
6125|013|C|COMMON BRAND NAME(S): Garamycin||
6125|014|B|||
6125|015|U|USES:  This medication is used to treat minor skin infections||
6125|016|U|(such as impetigo, folliculitis) or minor infections related to||
6125|017|U|some skin conditions (such as eczema, psoriasis, minor||
6125|018|U|burns/cuts/wounds). Gentamicin works by stopping the growth of||
6125|019|U|certain bacteria. It belongs to a class of drugs known as||
6125|020|U|aminoglycoside antibiotics.||
6125|021|U|   This antibiotic only treats bacterial infections. It will not||
6125|022|U|work for virus or fungus infections. Unnecessary use or overuse||
6125|023|U|of any antibiotic can lead to its decreased effectiveness.||
6125|024|B|||
6125|025|H|HOW TO USE:  This medication is for use on the skin only.||
6125|026|H|   Wash your hands before using. Clean and dry the affected area||
6125|027|H|as directed. If you are treating impetigo, remove any dried,||
6125|028|H|crusty skin to increase contact between the antibiotic and the||
6125|029|H|infected area. Then gently apply a small amount of medication in||
6125|030|H|a thin layer as directed by your doctor, usually 3 to 4 times a||
6125|031|H|day. You may cover the area with a sterile gauze bandage if so||
6125|032|H|directed. Keep the infected area clean. Wash your hands after||
6125|033|H|use, unless you are using this product to treat the hands.||
6125|034|H|   Avoid getting this medication in your eyes, nose, or mouth. If||
6125|035|H|this occurs, wipe off the medication and rinse thoroughly with||
6125|036|H|water.||
6125|037|H|   Dosage and length of treatment is based on your medical||
6125|038|H|condition and response to treatment.||
6125|039|H|   Use this medication regularly to get the most benefit from it.||
6125|040|H|To help you remember, use it at the same times each day. Do not||
6125|041|H|apply large amounts of this medication, use it more often, or use||
6125|042|H|it for longer than prescribed. Your condition will not improve||
6125|043|H|any faster, and your risk of side effects may increase.||
6125|044|H|   Continue to use this medication for the full time prescribed,||
6125|045|H|even if symptoms disappear after a few days. Stopping the||
6125|046|H|medication too early may result in a return of the infection.||
6125|047|H|   Tell your doctor if your skin infection lasts or if it gets||
6125|048|H|worse.||
6125|049|B|||
6125|050|S|SIDE EFFECTS:  Skin irritation, redness, and itching may occur.||
6125|051|S|If any of these effects last or get worse, tell your doctor or||
6125|052|S|pharmacist promptly.||
6125|053|S|   Remember that this medication has been prescribed because your||
6125|054|S|doctor has judged that the benefit to you is greater than the||
6125|055|S|risk of side effects. Many people using this medication do not||
6125|056|S|have serious side effects.||
6125|057|S|   Rarely, use of this medication for prolonged or repeated||
6125|058|S|periods may result in other types of skin infections (such as||
6125|059|S|fungal or other bacterial infections). Contact your doctor if you||
6125|060|S|notice any unusual skin symptoms or if your condition does not||
6125|061|S|improve.||
6125|062|S|   A very serious allergic reaction to this drug is rare.||
6125|063|S|However, get medical help right away if you notice any symptoms||
6125|064|S|of a serious allergic reaction, including: rash, itching/swelling||
6125|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6125|066|S|breathing.||
6125|067|S|   This is not a complete list of possible side effects. If you||
6125|068|S|notice other effects not listed above, contact your doctor or||
6125|069|S|pharmacist.||
6125|070|S|   In the US -||
6125|071|S|   Call your doctor for medical advice about side effects. You||
6125|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6125|073|S|www.fda.gov/medwatch.||
6125|074|S|   In Canada - Call your doctor for medical advice about side||
6125|075|S|effects. You may report side effects to Health Canada at||
6125|076|S|1-866-234-2345.||
6125|077|B|||
6125|078|P|PRECAUTIONS:  Before using gentamicin, tell your doctor or||
6125|079|P|pharmacist if you are allergic to it; or to other aminoglycoside||
6125|080|P|antibiotics (such as tobramycin, amikacin); or if you have any||
6125|081|P|other allergies. This product may contain inactive ingredients,||
6125|082|P|which can cause allergic reactions or other problems. Talk to||
6125|083|P|your pharmacist for more details.||
6125|084|P|   Before using this medication, tell your doctor or pharmacist||
6125|085|P|your medical history.||
6125|086|P|   Rarely, this medication may be absorbed into the blood if you||
6125|087|P|are applying it to large areas of skin, especially if the areas||
6125|088|P|are cracked, broken, or raw. Injured skin may absorb more of this||
6125|089|P|product, and the chance of serious side effects may increase.||
6125|090|P|Consult your doctor for more details.||
6125|091|P|   Before having surgery, tell your doctor or dentist about all||
6125|092|P|the products you use (including prescription drugs,||
6125|093|P|nonprescription drugs, and herbal products).||
6125|094|P|   During pregnancy, this medication should be used only when||
6125|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
6125|096|P|   It is unknown if this medication passes into breast milk.||
6125|097|P|However, this drug is unlikely to harm a nursing infant. Consult||
6125|098|P|your doctor before breastfeeding.||
6125|099|B|||
6125|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6125|101|I|medications work or increase your risk for serious side effects.||
6125|102|I|This document does not contain all possible drug interactions.||
6125|103|I|Keep a list of all the products you use (including||
6125|104|I|prescription/nonprescription drugs and herbal products) and share||
6125|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
6125|106|I|the dosage of any medicines without your doctor's approval.||
6125|107|B|||
6125|108|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6125|109|O|has overdosed and has serious symptoms such as passing out or||
6125|110|O|trouble breathing, call 911. Otherwise, call a poison control||
6125|111|O|center right away. US residents can call 1-800-222-1222. Canada||
6125|112|O|residents can call 1-844-764-7669.||
6125|113|B|||
6125|114|N|NOTES:  Do not share this medication with others.||
6125|115|N|   This medication has been prescribed for your current condition||
6125|116|N|only. Do not use it later for another infection unless your||
6125|117|N|doctor tells you to.||
6125|118|B|||
6125|119|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6125|120|D|If it is near the time of the next dose, skip the missed dose.||
6125|121|D|Use your next dose at the regular time. Do not double the dose to||
6125|122|D|catch up.||
6125|123|B|||
6125|124|R|STORAGE:  Store at room temperature. Keep all medications away||
6125|125|R|from children and pets.||
6125|126|R|   Do not flush medications down the toilet or pour them into a||
6125|127|R|drain unless instructed to do so. Properly discard this product||
6125|128|R|when it is expired or no longer needed. Consult your pharmacist||
6125|129|R|or local waste disposal company.||
6125|130|B|||
6125|131|A|Information last revised May 2024.||
6125|132|A|Copyright(c) 2025 First Databank, Inc.||
6125|133|B|||
6129|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6129|002|Z|does NOT have all possible information about this product. This||
6129|003|Z|information does not assure that this product is safe, effective,||
6129|004|Z|or appropriate for you. This information is not individual||
6129|005|Z|medical advice and does not substitute for the advice of your||
6129|006|Z|health care professional. Always ask your health care||
6129|007|Z|professional for complete information about this product and your||
6129|008|Z|specific health needs.||
6129|009|B|||
6129|010|T|SULFACETAMIDE SODIUM CREAM/GEL/LOTION - TOPICAL||
6129|011|F|(SUL-fa-SEET-a-mide SOE-dee-um)||
6129|012|B|||
6129|013|C|COMMON BRAND NAME(S): Ovace||
6129|014|B|||
6129|015|U|USES:  This medication is used to treat dandruff and other skin||
6129|016|U|conditions (such as seborrheic dermatitis). It is also used to||
6129|017|U|treat certain bacterial skin infections associated with these||
6129|018|U|conditions.||
6129|019|B|||
6129|020|H|HOW TO USE:  This medication is for use on the skin only. Avoid||
6129|021|H|getting any of this medication in the eyes, nose, or mouth.||
6129|022|H|   The directions for use of this product vary depending on the||
6129|023|H|brand that you are prescribed. Apply a thin layer to the affected||
6129|024|H|area as directed by your doctor, usually twice daily for 8 to 10||
6129|025|H|days. As your condition improves, your doctor may direct you to||
6129|026|H|continue treatment less often to keep it under control||
6129|027|H|(once/twice weekly or every other week). Tell your doctor if your||
6129|028|H|condition does not get better or if it gets worse.||
6129|029|B|||
6129|030|S|SIDE EFFECTS:  Irritation, stinging, and burning of the skin may||
6129|031|S|occur. If these effects last or get worse, tell your doctor||
6129|032|S|promptly.||
6129|033|S|   Remember that this medication has been prescribed because your||
6129|034|S|doctor has judged that the benefit to you is greater than the||
6129|035|S|risk of side effects. Many people using this medication do not||
6129|036|S|have serious side effects.||
6129|037|S|   Tell your doctor right away if you have any serious side||
6129|038|S|effects, including: severe redness/scaling of the skin,||
6129|039|S|muscle/joint aches, unusual tiredness, signs of liver problems||
6129|040|S|(such as nausea/vomiting that doesn't stop, yellowing eyes/skin,||
6129|041|S|stomach/abdominal pain), signs of infection (such as sore throat||
6129|042|S|that doesn't go away, fever, chills).||
6129|043|S|   A very serious allergic reaction to this drug is rare.||
6129|044|S|However, get medical help right away if you notice any symptoms||
6129|045|S|of a serious allergic reaction, including: rash, itching/swelling||
6129|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6129|047|S|breathing.||
6129|048|S|   This is not a complete list of possible side effects. If you||
6129|049|S|notice other effects not listed above, contact your doctor or||
6129|050|S|pharmacist.||
6129|051|S|   In the US -||
6129|052|S|   Call your doctor for medical advice about side effects. You||
6129|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6129|054|S|www.fda.gov/medwatch.||
6129|055|S|   In Canada - Call your doctor for medical advice about side||
6129|056|S|effects. You may report side effects to Health Canada at||
6129|057|S|1-866-234-2345.||
6129|058|B|||
6129|059|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6129|060|P|pharmacist if you are allergic to it; or to other sulfa drugs||
6129|061|P|such as sulfamethoxazole; or if you have any other allergies.||
6129|062|P|This product may contain inactive ingredients (such as sulfites),||
6129|063|P|which can cause allergic reactions or other problems. Talk to||
6129|064|P|your pharmacist for more details.||
6129|065|P|   Before using this medication, tell your doctor or pharmacist||
6129|066|P|your medical history, especially of: asthma.||
6129|067|P|   Use of this medication for prolonged or repeated periods may||
6129|068|P|result in a secondary infection (such as affecting the skin).||
6129|069|P|Consult your doctor or pharmacist.||
6129|070|P|   Before having surgery, tell your doctor or dentist about all||
6129|071|P|the products you use (including prescription drugs,||
6129|072|P|nonprescription drugs, and herbal products).||
6129|073|P|   During pregnancy, this medication should be used only when||
6129|074|P|clearly needed. Discuss the risks and benefits with your doctor.||
6129|075|P|   It is unknown if this drug passes into breast milk. Consult||
6129|076|P|your doctor before breastfeeding.||
6129|077|B|||
6129|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6129|079|I|medications work or increase your risk for serious side effects.||
6129|080|I|This document does not contain all possible drug interactions.||
6129|081|I|Keep a list of all the products you use (including||
6129|082|I|prescription/nonprescription drugs and herbal products) and share||
6129|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
6129|084|I|the dosage of any medicines without your doctor's approval.||
6129|085|I|   Some products that may interact with this drug include:||
6129|086|I|preparations containing silver.||
6129|087|B|||
6129|088|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6129|089|O|has overdosed and has serious symptoms such as passing out or||
6129|090|O|trouble breathing, call 911. Otherwise, call a poison control||
6129|091|O|center right away. US residents can call 1-800-222-1222. Canada||
6129|092|O|residents can call 1-844-764-7669.||
6129|093|B|||
6129|094|N|NOTES:  Do not share this medication with others.||
6129|095|B|||
6129|096|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6129|097|D|If it is near the time of the next dose, skip the missed dose.||
6129|098|D|Use your next dose at the regular time. Do not double the dose to||
6129|099|D|catch up.||
6129|100|B|||
6129|101|R|STORAGE:  Store at room temperature. Keep all medications away||
6129|102|R|from children and pets.||
6129|103|R|   Do not flush medications down the toilet or pour them into a||
6129|104|R|drain unless instructed to do so. Properly discard this product||
6129|105|R|when it is expired or no longer needed. Consult your pharmacist||
6129|106|R|or local waste disposal company.||
6129|107|B|||
6129|108|A|Information last revised April 2025.||
6129|109|A|Copyright(c) 2025 First Databank, Inc.||
6129|110|B|||
6130|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6130|002|Z|does NOT have all possible information about this product. This||
6130|003|Z|information does not assure that this product is safe, effective,||
6130|004|Z|or appropriate for you. This information is not individual||
6130|005|Z|medical advice and does not substitute for the advice of your||
6130|006|Z|health care professional. Always ask your health care||
6130|007|Z|professional for complete information about this product and your||
6130|008|Z|specific health needs.||
6130|009|B|||
6130|010|T|SODIUM SULFACETAMIDE/SULFUR - TOPICAL||
6130|011|F|(SOE-dee-um SUL-fa-SEET-a-mide/SUL-fur)||
6130|012|B|||
6130|013|C|COMMON BRAND NAME(S): Plexion TS, Rosula||
6130|014|B|||
6130|015|U|USES:  This medication is used to treat several skin problems||
6130|016|U|(acne, acne rosacea, seborrheic dermatitis). Sodium sulfacetamide||
6130|017|U|works by stopping the growth of certain bacteria on the skin that||
6130|018|U|can lead to acne and worsen these other skin conditions. It||
6130|019|U|belongs to a class of drugs known as sulfa antibiotics. Sulfur||
6130|020|U|works by helping remove the top layer of dead skin. It belongs to||
6130|021|U|a class of drugs known as keratolytics. It may also help kill||
6130|022|U|acne-causing bacteria and unclog pores.||
6130|023|U|   This medication may also contain other ingredients (for||
6130|024|U|example, other keratolytics such as urea).||
6130|025|B|||
6130|026|H|HOW TO USE:  This medication is for use on the skin only.||
6130|027|H|   Clean and dry the affected skin area and your hands. Some||
6130|028|H|products need to be shaken before use. If so directed on the||
6130|029|H|product label, shake the container well before each use. Apply a||
6130|030|H|thin layer of the product to the areas of skin with acne,||
6130|031|H|rosacea, or seborrhea as directed by your doctor, usually 1 to 3||
6130|032|H|times daily. The dosage is based on your medical condition and||
6130|033|H|response to treatment. Follow your doctor's directions. Wash your||
6130|034|H|hands with soap and water after each use.||
6130|035|H|   Do not apply this product to skin that is cracked, broken, or||
6130|036|H|raw because this may increase your risk of side effects.||
6130|037|H|   Avoid getting this medication on your eyelids or lips, or in||
6130|038|H|your eyes, nose, or mouth. If you do get medication in these||
6130|039|H|areas, rinse with plenty of water.||
6130|040|H|   Use this medication regularly to get the most benefit from it.||
6130|041|H|Do not apply large amounts of this medication, use it more often,||
6130|042|H|or use it for longer than prescribed. Your condition will not||
6130|043|H|improve any faster, and your risk of side effects may increase.||
6130|044|H|   Tell your doctor if your condition does not get better after a||
6130|045|H|few weeks or if it gets worse.||
6130|046|B|||
6130|047|S|SIDE EFFECTS:  Mild peeling of the top layer of skin is expected.||
6130|048|S|Skin irritation, redness, and scaling may also occur. If any of||
6130|049|S|these effects last or get worse, stop using this medication and||
6130|050|S|tell your doctor or pharmacist promptly.||
6130|051|S|   Remember that this medication has been prescribed because your||
6130|052|S|doctor has judged that the benefit to you is greater than the||
6130|053|S|risk of side effects. Many people using this medication do not||
6130|054|S|have serious side effects.||
6130|055|S|   Rarely, sodium sulfacetamide products applied to the skin may||
6130|056|S|be absorbed and may cause serious side effects. Stop using this||
6130|057|S|product and tell your doctor right away if you have any serious||
6130|058|S|side effects, including: aching/swollen joints, rash on nose and||
6130|059|S|cheeks, signs of infection (such as sore throat that doesn't go||
6130|060|S|away, fever, chills), signs of anemia (such as unusual||
6130|061|S|tiredness/weakness, rapid breathing, fast heartbeat), unusual||
6130|062|S|bleeding/bruising, signs of liver problems (such as nausea that||
6130|063|S|doesn't stop, dark urine, yellowing eyes/skin, stomach/abdominal||
6130|064|S|pain, vomiting), mouth sores.||
6130|065|S|   A very serious allergic reaction to this drug is rare.||
6130|066|S|However, get medical help right away if you notice any symptoms||
6130|067|S|of a serious allergic reaction, including: rash, itching/swelling||
6130|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6130|069|S|breathing.||
6130|070|S|   This is not a complete list of possible side effects. If you||
6130|071|S|notice other effects not listed above, contact your doctor or||
6130|072|S|pharmacist.||
6130|073|S|   In the US -||
6130|074|S|   Call your doctor for medical advice about side effects. You||
6130|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6130|076|S|www.fda.gov/medwatch.||
6130|077|S|   In Canada - Call your doctor for medical advice about side||
6130|078|S|effects. You may report side effects to Health Canada at||
6130|079|S|1-866-234-2345.||
6130|080|B|||
6130|081|P|PRECAUTIONS:  Before using this product, tell your doctor or||
6130|082|P|pharmacist if you are allergic to sodium sulfacetamide or sulfur;||
6130|083|P|or to sulfa antibiotics (such as sulfamethoxazole); or to other||
6130|084|P|ingredients listed on the product package; or if you have any||
6130|085|P|other allergies. This product may contain inactive ingredients,||
6130|086|P|which can cause allergic reactions or other problems. Talk to||
6130|087|P|your pharmacist for more details.||
6130|088|P|   Before using this medication, tell your doctor or pharmacist||
6130|089|P|your medical history, especially of: kidney problems.||
6130|090|P|   Tell your doctor if there are areas of skin near where this||
6130|091|P|product will be applied that are cracked, broken, or raw. Injured||
6130|092|P|skin may absorb more of this product, and the chance of serious||
6130|093|P|side effects may increase.||
6130|094|P|   Before having surgery, tell your doctor or dentist about all||
6130|095|P|the products you use (including prescription drugs,||
6130|096|P|nonprescription drugs, and herbal products).||
6130|097|P|   During pregnancy, this medication should be used only when||
6130|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
6130|099|P|   It is unknown if this drug passes into breast milk. Consult||
6130|100|P|your doctor before breastfeeding.||
6130|101|B|||
6130|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6130|103|I|medications work or increase your risk for serious side effects.||
6130|104|I|This document does not contain all possible drug interactions.||
6130|105|I|Keep a list of all the products you use (including||
6130|106|I|prescription/nonprescription drugs and herbal products) and share||
6130|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
6130|108|I|the dosage of any medicines without your doctor's approval.||
6130|109|I|   Some products that may interact with this drug are: skin||
6130|110|I|products containing silver (such as silver sulfadiazine).||
6130|111|B|||
6130|112|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6130|113|O|has overdosed and has serious symptoms such as passing out or||
6130|114|O|trouble breathing, call 911. Otherwise, call a poison control||
6130|115|O|center right away. US residents can call 1-800-222-1222. Canada||
6130|116|O|residents can call 1-844-764-7669.||
6130|117|B|||
6130|118|N|NOTES:  Do not share this medication with others.||
6130|119|B|||
6130|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6130|121|D|If it is near the time of the next dose, skip the missed dose.||
6130|122|D|Use your next dose at the regular time. Do not double the dose to||
6130|123|D|catch up.||
6130|124|B|||
6130|125|R|STORAGE:  Store at room temperature. Protect from freezing. Keep||
6130|126|R|all medications away from children and pets.||
6130|127|R|   Do not flush medications down the toilet or pour them into a||
6130|128|R|drain unless instructed to do so. Properly discard this product||
6130|129|R|when it is expired or no longer needed. Consult your pharmacist||
6130|130|R|or local waste disposal company.||
6130|131|B|||
6130|132|A|Information last revised November 2025.||
6130|133|A|Copyright(c) 2025 First Databank, Inc.||
6130|134|B|||
6132|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6132|002|Z|does NOT have all possible information about this product. This||
6132|003|Z|information does not assure that this product is safe, effective,||
6132|004|Z|or appropriate for you. This information is not individual||
6132|005|Z|medical advice and does not substitute for the advice of your||
6132|006|Z|health care professional. Always ask your health care||
6132|007|Z|professional for complete information about this product and your||
6132|008|Z|specific health needs.||
6132|009|B|||
6132|010|T|ONDANSETRON - ORAL||
6132|011|F|(on-DAN-se-tron)||
6132|012|B|||
6132|013|C|COMMON BRAND NAME(S): Zofran||
6132|014|B|||
6132|015|U|USES:  This medication is used alone or with other medications to||
6132|016|U|prevent nausea and vomiting caused by cancer drug treatment||
6132|017|U|(chemotherapy) and radiation therapy. It is also used to prevent||
6132|018|U|and treat nausea and vomiting after surgery. It works by blocking||
6132|019|U|one of the body's natural substances (serotonin) that causes||
6132|020|U|vomiting.||
6132|021|B|||
6132|022|H|HOW TO USE:  To prevent nausea from chemotherapy, take this||
6132|023|H|medication by mouth usually within 30 minutes before treatment||
6132|024|H|begins. To prevent nausea from radiation treatment, take this||
6132|025|H|medication by mouth 1 to 2 hours before the start of your||
6132|026|H|treatment. To prevent nausea after surgery, take ondansetron by||
6132|027|H|mouth 1 hour before the start of surgery. This medication may be||
6132|028|H|taken with or without food. However, your doctor may tell you not||
6132|029|H|to eat before chemotherapy, radiation, or surgery.||
6132|030|H|   If you are using the liquid form of this medication, use a||
6132|031|H|special measuring spoon or device to measure out your prescribed||
6132|032|H|dose. Do not use a household spoon because you may not get the||
6132|033|H|correct dose.||
6132|034|H|   Take any other doses as directed by your doctor. Ondansetron||
6132|035|H|may be taken up to 3 times a day for 1 to 2 days after your||
6132|036|H|chemotherapy or radiation treatment is finished. If you are||
6132|037|H|taking this medication on a prescribed schedule, take it||
6132|038|H|regularly in order to get the most benefit from it. To help you||
6132|039|H|remember, take it at the same times each day.||
6132|040|H|   The dosage is based on your medical condition and response to||
6132|041|H|treatment. Children's dosage may also be based on age and weight.||
6132|042|H|Take this medication exactly as directed. Do not take more||
6132|043|H|medication or take it more often than prescribed. Ask your doctor||
6132|044|H|or pharmacist if you have questions.||
6132|045|H|   Tell your doctor if your condition does not get better or if||
6132|046|H|it gets worse.||
6132|047|B|||
6132|048|S|SIDE EFFECTS:  Headache, lightheadedness, dizziness, drowsiness,||
6132|049|S|tiredness, or constipation may occur. If these effects last or||
6132|050|S|get worse, tell your doctor promptly.||
6132|051|S|   To reduce the risk of dizziness and lightheadedness, get up||
6132|052|S|slowly when rising from a sitting or lying position.||
6132|053|S|   Remember that this medication has been prescribed because your||
6132|054|S|doctor has judged that the benefit to you is greater than the||
6132|055|S|risk of side effects. Many people using this medication do not||
6132|056|S|have serious side effects.||
6132|057|S|   Tell your doctor right away if you have any serious side||
6132|058|S|effects, including: stomach pain, muscle spasm/stiffness, vision||
6132|059|S|changes (such as temporary loss of vision, blurred vision).||
6132|060|S|   Get medical help right away if you have any very serious side||
6132|061|S|effects, including: chest pain, slow/fast/irregular heartbeat,||
6132|062|S|severe dizziness, fainting.||
6132|063|S|   This medication may increase serotonin and rarely cause a very||
6132|064|S|serious condition called serotonin syndrome/toxicity. The risk||
6132|065|S|increases if you are also taking other drugs that increase||
6132|066|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
6132|067|S|take (see Drug Interactions section). Get medical help right away||
6132|068|S|if you develop some of the following symptoms: fast heartbeat,||
6132|069|S|hallucinations, loss of coordination, severe dizziness, severe||
6132|070|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
6132|071|S|unusual agitation/restlessness.||
6132|072|S|   A very serious allergic reaction to this drug is rare.||
6132|073|S|However, get medical help right away if you notice any symptoms||
6132|074|S|of a serious allergic reaction, including: rash, itching/swelling||
6132|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6132|076|S|breathing.||
6132|077|S|   This is not a complete list of possible side effects. If you||
6132|078|S|notice other effects not listed above, contact your doctor or||
6132|079|S|pharmacist.||
6132|080|S|   In the US -||
6132|081|S|   Call your doctor for medical advice about side effects. You||
6132|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6132|083|S|www.fda.gov/medwatch.||
6132|084|S|   In Canada - Call your doctor for medical advice about side||
6132|085|S|effects. You may report side effects to Health Canada at||
6132|086|S|1-866-234-2345.||
6132|087|B|||
6132|088|P|PRECAUTIONS:  Before taking ondansetron, tell your doctor or||
6132|089|P|pharmacist if you are allergic to it; or to other serotonin||
6132|090|P|blockers (such as granisetron); or if you have any other||
6132|091|P|allergies. This product may contain inactive ingredients, which||
6132|092|P|can cause allergic reactions or other problems. Talk to your||
6132|093|P|pharmacist for more details.||
6132|094|P|   Before using this medication, tell your doctor or pharmacist||
6132|095|P|your medical history, especially of: irregular heartbeat, liver||
6132|096|P|disease, stomach/intestinal problems (such as recent abdominal||
6132|097|P|surgery, ileus, swelling).||
6132|098|P|   Ondansetron may cause a condition that affects the heart||
6132|099|P|rhythm (QT prolongation). QT prolongation can rarely cause||
6132|100|P|serious (rarely fatal) fast/irregular heartbeat and other||
6132|101|P|symptoms (such as severe dizziness, fainting) that need medical||
6132|102|P|attention right away.||
6132|103|P|   The risk of QT prolongation may be increased if you have||
6132|104|P|certain medical conditions or are taking other drugs that may||
6132|105|P|cause QT prolongation. Before using ondansetron, tell your doctor||
6132|106|P|or pharmacist of all the drugs you take and if you have any of||
6132|107|P|the following conditions: certain heart problems (heart failure,||
6132|108|P|slow heartbeat, QT prolongation in the EKG), family history of||
6132|109|P|certain heart problems (QT prolongation in the EKG, sudden||
6132|110|P|cardiac death).||
6132|111|P|   Low levels of potassium or magnesium in the blood may also||
6132|112|P|increase your risk of QT prolongation. This risk may increase if||
6132|113|P|you use certain drugs (such as diuretics/"water pills") or if you||
6132|114|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6132|115|P|Talk to your doctor about using ondansetron safely.||
6132|116|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6132|117|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6132|118|P|machinery, or do anything that needs alertness until you can do||
6132|119|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
6132|120|P|are using marijuana (cannabis).||
6132|121|P|   Older adults may be more sensitive to the side effects of this||
6132|122|P|drug, especially QT prolongation (see above).||
6132|123|P|   During pregnancy, this medication should be used only when||
6132|124|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
6132|125|P|benefits with your doctor.||
6132|126|P|   This medication passes into breast milk. Consult your doctor||
6132|127|P|before breastfeeding.||
6132|128|B|||
6132|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6132|130|I|medications work or increase your risk for serious side effects.||
6132|131|I|This document does not contain all possible drug interactions.||
6132|132|I|Keep a list of all the products you use (including||
6132|133|I|prescription/nonprescription drugs and herbal products) and share||
6132|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
6132|135|I|the dosage of any medicines without your doctor's approval.||
6132|136|I|   Some products that may interact with this drug are:||
6132|137|I|apomorphine, tramadol.||
6132|138|I|   The risk of serotonin syndrome/toxicity increases if you are||
6132|139|I|also taking other drugs that increase serotonin. Examples include||
6132|140|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
6132|141|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
6132|142|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
6132|143|I|serotonin syndrome/toxicity may be more likely when you start or||
6132|144|I|increase the dose of these drugs.||
6132|145|B|||
6132|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6132|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6132|148|O|poison control center right away. US residents can call||
6132|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6132|150|B|||
6132|151|N|NOTES:  Do not share this product with others.||
6132|152|N|   Lab and/or medical tests (such as EKG) should be done while||
6132|153|N|you are taking this medication. Keep all medical and lab||
6132|154|N|appointments. Consult your doctor for more details.||
6132|155|B|||
6132|156|D|MISSED DOSE:  Try to take each dose at the scheduled time. If you||
6132|157|D|miss a dose, take it as soon as remembered unless it is near the||
6132|158|D|time for the next dose. In that case, skip the missed dose. Take||
6132|159|D|your next dose at the regular time. Do not double the dose to||
6132|160|D|catch up.||
6132|161|B|||
6132|162|R|STORAGE:  Different brands of this medication have different||
6132|163|R|storage needs. Check the product package for instructions on how||
6132|164|R|to store your brand, or ask your pharmacist. Keep all medications||
6132|165|R|away from children and pets.||
6132|166|R|   Do not flush medications down the toilet or pour them into a||
6132|167|R|drain unless instructed to do so. Properly discard this product||
6132|168|R|when it is expired or no longer needed. Consult your pharmacist||
6132|169|R|or local waste disposal company.||
6132|170|B|||
6132|171|A|Information last revised June 2025.||
6132|172|A|Copyright(c) 2025 First Databank, Inc.||
6132|173|B|||
6133|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6133|002|Z|does NOT have all possible information about this product. This||
6133|003|Z|information does not assure that this product is safe, effective,||
6133|004|Z|or appropriate for you. This information is not individual||
6133|005|Z|medical advice and does not substitute for the advice of your||
6133|006|Z|health care professional. Always ask your health care||
6133|007|Z|professional for complete information about this product and your||
6133|008|Z|specific health needs.||
6133|009|B|||
6133|010|T|ETOPOSIDE PHOSPHATE - INJECTION||
6133|011|F|(e-TOE-poe-side FOS-fate)||
6133|012|B|||
6133|013|C|COMMON BRAND NAME(S): Etopophos||
6133|014|B|||
6133|015|W|WARNING:  This medication may cause certain severe blood and bone||
6133|016|W|marrow problems (low red blood cells/white blood||
6133|017|W|cells/platelets). This can affect your body's ability to stop||
6133|018|W|bleeding or fight infection. Tell your doctor right away if you||
6133|019|W|develop unusual tiredness, signs of infection (such as sore||
6133|020|W|throat that doesn't go away, fever, chills), or easy||
6133|021|W|bruising/bleeding (such as black stools, bloody vomit).||
6133|022|B|||
6133|023|U|USES:  Etoposide is used to treat testicular cancer and certain||
6133|024|U|forms of lung cancer (such as small cell lung cancer). Etoposide||
6133|025|U|works by slowing the growth of cancer cells.||
6133|026|B|||
6133|027|V|OTHER USES:  This section contains uses of this drug that are not||
6133|028|V|listed in the approved professional labeling for the drug but||
6133|029|V|that may be prescribed by your health care professional. Use this||
6133|030|V|drug for a condition that is listed in this section only if it||
6133|031|V|has been so prescribed by your health care professional.||
6133|032|V|   This drug may also be used for other types of cancer (such as||
6133|033|V|leukemias, lymphomas, ovarian cancer, bone cancer, prostate||
6133|034|V|cancer).||
6133|035|B|||
6133|036|H|HOW TO USE:  This medication is given by slow injection into a||
6133|037|H|vein by a health care professional. It is given as directed by||
6133|038|H|your doctor, usually every day or every other day for a total of||
6133|039|H|3 to 5 doses. This cycle may be repeated every 3 to 4 weeks.||
6133|040|H|   This medication may cause low blood pressure. Tell your doctor||
6133|041|H|or other health care professional if you feel dizzy. Your||
6133|042|H|injection may need to be stopped or given more slowly.||
6133|043|H|   The dosage is based on your medical condition, body size, and||
6133|044|H|response to treatment. Your doctor will check your blood counts||
6133|045|H|to make sure you can receive your next cycle. Keep all regular||
6133|046|H|medical and lab appointments.||
6133|047|B|||
6133|048|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
6133|049|S|   Nausea, vomiting, diarrhea, dizziness, tiredness, weakness,||
6133|050|S|changes in taste, loss of appetite, and pain/redness at the||
6133|051|S|injection site may occur. Nausea and vomiting can be severe. In||
6133|052|S|some cases, your doctor may prescribe medication to prevent or||
6133|053|S|relieve nausea and vomiting. Eating several small meals, not||
6133|054|S|eating before treatment, or limiting activity may help lessen||
6133|055|S|some of these effects. If any of these effects last or get worse,||
6133|056|S|tell your doctor or pharmacist promptly.||
6133|057|S|   Temporary hair loss may occur. Normal hair growth should||
6133|058|S|return after treatment has ended.||
6133|059|S|   Pain or sores in the mouth and throat may occur. Brush your||
6133|060|S|teeth carefully/gently, avoid using mouthwash that contains||
6133|061|S|alcohol, and rinse your mouth often with cool water mixed with||
6133|062|S|baking soda or salt. It may also be best to eat soft, moist||
6133|063|S|foods.||
6133|064|S|   Many people using this medication may have serious side||
6133|065|S|effects. However, you have been prescribed this drug because your||
6133|066|S|doctor has judged that the benefit to you is greater than the||
6133|067|S|risk of side effects. Careful monitoring by your doctor may||
6133|068|S|decrease your risk.||
6133|069|S|   Tell your doctor right away if you have any serious side||
6133|070|S|effects, including: numbness/tingling of arms/legs, sudden vision||
6133|071|S|changes, eye pain, stomach/abdominal pain, yellowing eyes/skin,||
6133|072|S|dark urine, painful/difficult swallowing, redness/swelling of||
6133|073|S|your veins.||
6133|074|S|   This medication may lower your ability to fight infections.||
6133|075|S|This may make you more likely to get a serious (rarely fatal)||
6133|076|S|infection or make any infection you have worse. Tell your doctor||
6133|077|S|right away if you have any signs of infection (such as sore||
6133|078|S|throat that doesn't go away, fever, chills).||
6133|079|S|   Although etoposide may be used to treat certain leukemias, it||
6133|080|S|may rarely cause acute leukemia. Ask your doctor for more||
6133|081|S|details.||
6133|082|S|   A very serious allergic reaction to this drug is rare.||
6133|083|S|However, get medical help right away if you notice any symptoms||
6133|084|S|of a serious allergic reaction, including: rash, itching/swelling||
6133|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6133|086|S|breathing, fast heartbeat, seizures.||
6133|087|S|   This is not a complete list of possible side effects. If you||
6133|088|S|notice other effects not listed above, contact your doctor or||
6133|089|S|pharmacist.||
6133|090|S|   In the US -||
6133|091|S|   Call your doctor for medical advice about side effects. You||
6133|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6133|093|S|www.fda.gov/medwatch.||
6133|094|S|   In Canada - Call your doctor for medical advice about side||
6133|095|S|effects. You may report side effects to Health Canada at||
6133|096|S|1-866-234-2345.||
6133|097|B|||
6133|098|P|PRECAUTIONS:  Before using etoposide, tell your doctor or||
6133|099|P|pharmacist if you are allergic to it; or if you have any other||
6133|100|P|allergies. This product may contain inactive ingredients, which||
6133|101|P|can cause allergic reactions or other problems. Talk to your||
6133|102|P|pharmacist for more details.||
6133|103|P|   Before using this medication, tell your doctor or pharmacist||
6133|104|P|your medical history, especially of: blood problems (such as low||
6133|105|P|red blood cells/white blood cells/platelets), liver disease,||
6133|106|P|kidney disease, previous radiation/chemotherapy treatment, heart||
6133|107|P|problems.||
6133|108|P|   Etoposide can make you more likely to get infections or may||
6133|109|P|make current infections worse. Stay away from anyone who has an||
6133|110|P|infection that may easily spread (such as chickenpox, COVID-19,||
6133|111|P|measles, flu). Talk to your doctor if you have been exposed to an||
6133|112|P|infection or for more details.||
6133|113|P|   Tell your health care professional that you are using||
6133|114|P|etoposide before having any immunizations/vaccinations. Avoid||
6133|115|P|contact with people who have recently received live vaccines||
6133|116|P|(such as flu vaccine inhaled through the nose).||
6133|117|P|   To lower the chance of getting cut, bruised, or injured, use||
6133|118|P|caution with sharp objects like razors and nail cutters, and||
6133|119|P|avoid activities such as contact sports.||
6133|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6133|121|P|can make you more dizzy. Do not drive, use machinery, or do||
6133|122|P|anything that needs alertness until you can do it safely. Limit||
6133|123|P|alcoholic beverages. Talk to your doctor if you are using||
6133|124|P|marijuana (cannabis).||
6133|125|P|   Daily use of alcohol while using this medicine may increase||
6133|126|P|your risk for stomach bleeding. Ask your doctor or pharmacist||
6133|127|P|about how much alcohol you may safely drink.||
6133|128|P|   Before having surgery, tell your doctor or dentist about all||
6133|129|P|the products you use (including prescription drugs,||
6133|130|P|nonprescription drugs, and herbal products).||
6133|131|P|   Children may be more sensitive to the side effects of this||
6133|132|P|drug, especially allergic effects.||
6133|133|P|   Older adults may be more sensitive to the side effects of this||
6133|134|P|drug, especially drowsiness, weakness, mouth/throat sores, loss||
6133|135|P|of appetite, low white blood cells, and dehydration.||
6133|136|P|   This medication can affect fertility in both males and||
6133|137|P|females. Ask your doctor for more details.||
6133|138|P|   Tell your doctor if you are pregnant or plan to become||
6133|139|P|pregnant. You should not become pregnant while using etoposide.||
6133|140|P|Etoposide may harm an unborn baby. Women using this medication||
6133|141|P|should ask about reliable forms of birth control during treatment||
6133|142|P|and for 6 months after the last dose. Men using this medication||
6133|143|P|should ask about reliable forms of birth control during treatment||
6133|144|P|and for 4 months after the last dose. If you or your partner||
6133|145|P|becomes pregnant, talk to your doctor right away about the risks||
6133|146|P|and benefits of this medication.||
6133|147|P|   Etoposide passes into breast milk. Because of the possible||
6133|148|P|risk to the infant, breastfeeding is not recommended while using||
6133|149|P|this medication. Consult your doctor before breastfeeding.||
6133|150|B|||
6133|151|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6133|152|I|medications work or increase your risk for serious side effects.||
6133|153|I|This document does not contain all possible drug interactions.||
6133|154|I|Keep a list of all the products you use (including||
6133|155|I|prescription/nonprescription drugs and herbal products) and share||
6133|156|I|it with your doctor and pharmacist. Do not start, stop, or change||
6133|157|I|the dosage of any medicines without your doctor's approval.||
6133|158|B|||
6133|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6133|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6133|161|O|poison control center right away. US residents can call||
6133|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6133|163|B|||
6133|164|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
6133|165|N|kidney/liver function) should be done while you are using this||
6133|166|N|medication. Keep all medical and lab appointments. Consult your||
6133|167|N|doctor for more details.||
6133|168|B|||
6133|169|D|MISSED DOSE:  It is important to get each dose of this medication||
6133|170|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6133|171|D|right away for a new dosing schedule.||
6133|172|B|||
6133|173|R|STORAGE:  Consult the product instructions and your pharmacist||
6133|174|R|for storage details. Keep all medications away from children and||
6133|175|R|pets.||
6133|176|R|   Do not flush medications down the toilet or pour them into a||
6133|177|R|drain unless instructed to do so. Properly discard this product||
6133|178|R|when it is expired or no longer needed. Consult your pharmacist||
6133|179|R|or local waste disposal company.||
6133|180|B|||
6133|181|M|MEDICAL ALERT:  Your condition can cause complications in a||
6133|182|M|medical emergency. For information about enrolling in MedicAlert,||
6133|183|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6133|184|B|||
6133|185|A|Information last revised May 2025.||
6133|186|A|Copyright(c) 2025 First Databank, Inc.||
6133|187|B|||
6134|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6134|002|Z|does NOT have all possible information about this product. This||
6134|003|Z|information does not assure that this product is safe, effective,||
6134|004|Z|or appropriate for you. This information is not individual||
6134|005|Z|medical advice and does not substitute for the advice of your||
6134|006|Z|health care professional. Always ask your health care||
6134|007|Z|professional for complete information about this product and your||
6134|008|Z|specific health needs.||
6134|009|B|||
6134|010|T|MITOMYCIN - INJECTION||
6134|011|F|(MYE-toe-MYE-sin)||
6134|012|B|||
6134|013|C|COMMON BRAND NAME(S): Mutamycin||
6134|014|B|||
6134|015|W|WARNING:  Mitomycin may cause serious blood and bone marrow||
6134|016|W|disorders (such as low red blood cells/white blood||
6134|017|W|cells/platelets). These problems can affect your body's ability||
6134|018|W|to stop bleeding or fight infection. Tell your doctor right away||
6134|019|W|if you develop easy bleeding/bruising or signs of an infection||
6134|020|W|(such as sore throat that doesn't go away, fever, chills).||
6134|021|W|   This drug may cause a certain serious, sometimes fatal side||
6134|022|W|effect (hemolytic uremic syndrome). This condition may result in||
6134|023|W|anemia, low platelet counts, and kidney problems. Blood||
6134|024|W|transfusions may make the symptoms worse. Tell your doctor right||
6134|025|W|away if you have any of the following signs: pink/bloody urine or||
6134|026|W|change in the amount of urine.||
6134|027|B|||
6134|028|U|USES:  Mitomycin is used to treat various types of cancer (such||
6134|029|U|as stomach/pancreas cancer). It works by slowing or stopping the||
6134|030|U|growth of cancer cells.||
6134|031|B|||
6134|032|V|OTHER USES:  This section contains uses of this drug that are not||
6134|033|V|listed in the approved professional labeling for the drug but||
6134|034|V|that may be prescribed by your health care professional. Use this||
6134|035|V|drug for a condition that is listed in this section only if it||
6134|036|V|has been so prescribed by your health care professional.||
6134|037|V|   This drug may also be used for other types of cancers (such as||
6134|038|V|lung cancer).||
6134|039|B|||
6134|040|H|HOW TO USE:  This medication is given by injection into a vein by||
6134|041|H|a health care professional. The dosage is based on your medical||
6134|042|H|condition, body size, and response to treatment.||
6134|043|B|||
6134|044|S|SIDE EFFECTS:  See also Warning section.||
6134|045|S|   Nausea, vomiting, stomach/abdominal pain, or loss of appetite||
6134|046|S|may occur. Nausea and vomiting can be severe. In some cases, your||
6134|047|S|doctor may prescribe medication to prevent or relieve nausea and||
6134|048|S|vomiting. Eating several small meals, not eating before||
6134|049|S|treatment, or limiting activity may help lessen some of these||
6134|050|S|effects. If any of these effects last or get worse, tell your||
6134|051|S|doctor or pharmacist promptly.||
6134|052|S|   Temporary hair loss may occur. Normal hair growth should||
6134|053|S|return after treatment has ended.||
6134|054|S|   Pain or sores in the mouth and throat may occur. Brush your||
6134|055|S|teeth gently/carefully, avoid using mouthwash that contains||
6134|056|S|alcohol, and rinse your mouth often with cool water mixed with||
6134|057|S|baking soda or salt. It may also be best to eat soft, moist||
6134|058|S|foods.||
6134|059|S|   People using this medication may have serious side effects.||
6134|060|S|However, you have been prescribed this drug because your doctor||
6134|061|S|has judged that the benefit to you is greater than the risk of||
6134|062|S|side effects. Careful monitoring by your doctor may decrease your||
6134|063|S|risk.||
6134|064|S|   Severe nausea and vomiting may rarely cause dehydration.||
6134|065|S|Contact your doctor promptly if you notice any symptoms of||
6134|066|S|dehydration such as unusual decreased urination, unusual dry||
6134|067|S|mouth/increased thirst, lack of tears, dizziness/lightheadedness,||
6134|068|S|or pale/wrinkled skin.||
6134|069|S|   Tell your doctor right away if you have any serious side||
6134|070|S|effects, including: unusual bleeding/bruising (such as small red||
6134|071|S|spots on the skin, black/bloody stools, vomit that looks like||
6134|072|S|coffee grounds), numbness/tingling feelings, unusual||
6134|073|S|tiredness/weakness.||
6134|074|S|   If this medication accidentally leaks into the skin/muscle||
6134|075|S|around the injection site, it may cause severe damage. Symptoms||
6134|076|S|may occur both during treatment or weeks to months after||
6134|077|S|receiving a dose. Tell your doctor right away if you notice||
6134|078|S|redness, pain, or swelling at or near the injection site.||
6134|079|S|   A very serious allergic reaction to this drug is rare.||
6134|080|S|However, get medical help right away if you notice any symptoms||
6134|081|S|of a serious allergic reaction, including: rash, itching/swelling||
6134|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6134|083|S|breathing (especially with cough).||
6134|084|S|   This is not a complete list of possible side effects. If you||
6134|085|S|notice other effects not listed above, contact your doctor or||
6134|086|S|pharmacist.||
6134|087|S|   In the US -||
6134|088|S|   Call your doctor for medical advice about side effects. You||
6134|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6134|090|S|www.fda.gov/medwatch.||
6134|091|S|   In Canada - Call your doctor for medical advice about side||
6134|092|S|effects. You may report side effects to Health Canada at||
6134|093|S|1-866-234-2345.||
6134|094|B|||
6134|095|P|PRECAUTIONS:  Before using mitomycin, tell your doctor or||
6134|096|P|pharmacist if you are allergic to it; or if you have any other||
6134|097|P|allergies. This product may contain inactive ingredients, which||
6134|098|P|can cause allergic reactions or other problems. Talk to your||
6134|099|P|pharmacist for more details.||
6134|100|P|   Before using this medication, tell your doctor or pharmacist||
6134|101|P|your medical history, especially of: blood/bleeding disorders||
6134|102|P|(such as anemia, low blood cell counts), current infection,||
6134|103|P|kidney disease, liver disease, radiation treatment.||
6134|104|P|   Tell your health care professional that you are using||
6134|105|P|mitomycin before having any immunizations/vaccinations. Avoid||
6134|106|P|contact with people who have recently received live vaccines||
6134|107|P|(such as flu vaccine inhaled through the nose).||
6134|108|P|   Mitomycin can make you more likely to get infections or may||
6134|109|P|worsen any current infections. Avoid contact with people who have||
6134|110|P|infections that may spread to others (such as chickenpox,||
6134|111|P|measles, flu). Consult your doctor if you have been exposed to an||
6134|112|P|infection or for more details.||
6134|113|P|   To lower your risk of getting cut, bruised, or injured, use||
6134|114|P|caution with sharp objects like razors and nail cutters, and||
6134|115|P|avoid activities such as contact sports.||
6134|116|P|   Before having surgery, tell your doctor or dentist about all||
6134|117|P|the products you use (including prescription drugs,||
6134|118|P|nonprescription drugs, and herbal products).||
6134|119|P|   Tell your doctor if you are pregnant or plan to become||
6134|120|P|pregnant. You should not become pregnant while using mitomycin.||
6134|121|P|Mitomycin may harm an unborn baby. Men and women using this||
6134|122|P|medication should ask about reliable forms of birth control||
6134|123|P|during treatment. If you or your partner becomes pregnant, talk||
6134|124|P|to your doctor right away about the risks and benefits of this||
6134|125|P|medication.||
6134|126|P|   It is unknown if this drug passes into breast milk. Because of||
6134|127|P|the possible risk to the infant, breastfeeding is not recommended||
6134|128|P|while using this drug. Consult your doctor before breastfeeding.||
6134|129|B|||
6134|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6134|131|I|medications work or increase your risk for serious side effects.||
6134|132|I|This document does not contain all possible drug interactions.||
6134|133|I|Keep a list of all the products you use (including||
6134|134|I|prescription/nonprescription drugs and herbal products) and share||
6134|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
6134|136|I|the dosage of any medicines without your doctor's approval.||
6134|137|I|   Some products that may interact with this drug include: other||
6134|138|I|anti-cancer drugs (especially vinca alkaloids such as||
6134|139|I|vinblastine).||
6134|140|B|||
6134|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6134|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6134|143|O|poison control center right away. US residents can call||
6134|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6134|145|B|||
6134|146|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
6134|147|N|kidney function) should be done while you are using this||
6134|148|N|medication. Keep all medical and lab appointments. Consult your||
6134|149|N|doctor for more details.||
6134|150|B|||
6134|151|D|MISSED DOSE:  It is important to get each dose of this medication||
6134|152|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6134|153|D|right away for a new dosing schedule.||
6134|154|B|||
6134|155|R|STORAGE:  Not applicable. This medication is given in a hospital||
6134|156|R|or clinic and will not be stored at home.||
6134|157|B|||
6134|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
6134|159|M|medical emergency. For information about enrolling in MedicAlert,||
6134|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6134|161|B|||
6134|162|A|Information last revised October 2024.||
6134|163|A|Copyright(c) 2025 First Databank, Inc.||
6134|164|B|||
6135|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6135|002|Z|does NOT have all possible information about this product. This||
6135|003|Z|information does not assure that this product is safe, effective,||
6135|004|Z|or appropriate for you. This information is not individual||
6135|005|Z|medical advice and does not substitute for the advice of your||
6135|006|Z|health care professional. Always ask your health care||
6135|007|Z|professional for complete information about this product and your||
6135|008|Z|specific health needs.||
6135|009|B|||
6135|010|T|LOMUSTINE - ORAL||
6135|011|F|(loe-MUS-teen)||
6135|012|B|||
6135|013|C|COMMON BRAND NAME(S): Ceenu, Gleostine||
6135|014|B|||
6135|015|W|WARNING:  Lomustine decreases bone marrow function, an effect||
6135|016|W|(possibly fatal) that may lead to a low number of blood cells||
6135|017|W|such as red cells, white cells, and platelets. This effect can||
6135|018|W|cause anemia, decrease your body's ability to fight an infection,||
6135|019|W|or cause easy bruising/bleeding. These side effects usually occur||
6135|020|W|4 to 6 weeks after your dose and may last for 1 to 2 weeks. Tell||
6135|021|W|your doctor right away if you develop any of the following||
6135|022|W|symptoms: unusual tiredness, pale skin, signs of infection (such||
6135|023|W|as sore throat that doesn't go away, fever, chills), easy||
6135|024|W|bruising/bleeding.||
6135|025|W|   Your doctor will closely monitor you and perform weekly blood||
6135|026|W|tests for at least 6 weeks after each dose. Your dose and any||
6135|027|W|further treatment will be based on your blood tests. Due to||
6135|028|W|serious side effects, do not take this medication more often than||
6135|029|W|once every 6 weeks. Follow your doctor's instructions carefully.||
6135|030|B|||
6135|031|U|USES:  This medication is used to treat various types of cancer.||
6135|032|U|Lomustine belongs to a class of drugs known as alkylating agents.||
6135|033|U|It works by slowing or stopping the growth of cancer cells.||
6135|034|B|||
6135|035|H|HOW TO USE:  See also Warning section.||
6135|036|H|   Take this medication by mouth as a single dose as directed by||
6135|037|H|your doctor, usually once every 6 weeks. Your dose may consist of||
6135|038|H|2 or more different strengths/colors of capsules. To prevent||
6135|039|H|nausea and vomiting, take this medication on an empty stomach at||
6135|040|H|least 1 hour before or 2 to 3 hours after a meal with a full||
6135|041|H|glass of water (8 ounces/240 milliliters) unless your doctor||
6135|042|H|directs you otherwise. Swallow the capsules whole.||
6135|043|H|   The dosage is based on your medical condition, response to||
6135|044|H|treatment, body size, and lab tests.||
6135|045|H|   Do not increase your dose or use this drug more often or for||
6135|046|H|longer than prescribed. Your condition will not improve any||
6135|047|H|faster, and your risk of side effects will increase.||
6135|048|H|   Wear rubber or latex gloves when you handle the capsules.||
6135|049|H|   Since this drug can be absorbed through the skin and lungs and||
6135|050|H|may harm an unborn baby, women who are pregnant or who may become||
6135|051|H|pregnant should not handle this medication or breathe the dust||
6135|052|H|from the capsules.||
6135|053|B|||
6135|054|S|SIDE EFFECTS:  See also Warning section.||
6135|055|S|   Nausea, vomiting, loss of appetite, diarrhea, or mouth/lip||
6135|056|S|sores may occur. Nausea and vomiting usually last for less than||
6135|057|S|24 hours and loss of appetite may last for several days. Nausea||
6135|058|S|and vomiting can be severe. In some cases, your doctor may||
6135|059|S|prescribe medication to prevent or relieve nausea and vomiting.||
6135|060|S|Eating several small meals, not eating before treatment, or||
6135|061|S|limiting activity may help lessen some of these effects. If any||
6135|062|S|of these effects last or get worse, tell your doctor or||
6135|063|S|pharmacist promptly.||
6135|064|S|   Temporary hair loss may occur. Normal hair growth should||
6135|065|S|return after treatment has ended.||
6135|066|S|   Remember that this medication has been prescribed because your||
6135|067|S|doctor has judged that the benefit to you is greater than the||
6135|068|S|risk of side effects. Many people using this medication do not||
6135|069|S|have serious side effects.||
6135|070|S|   Tell your doctor right away if you have any serious side||
6135|071|S|effects, including: confusion, swelling of lower legs/feet,||
6135|072|S|vision changes.||
6135|073|S|   Get medical help right away if you have any very serious side||
6135|074|S|effects, including: stomach/abdominal pain that doesn't go away,||
6135|075|S|black stools, vomit that looks like coffee grounds, yellowing||
6135|076|S|eyes/skin, dark urine, signs of kidney problems (such as change||
6135|077|S|in the amount of urine, pink urine).||
6135|078|S|   A severe (sometimes fatal) lung problem (pulmonary fibrosis)||
6135|079|S|has occurred in people taking this drug. This condition can occur||
6135|080|S|months to years after you start taking this medication. Get||
6135|081|S|medical help right away if you experience any of these serious||
6135|082|S|side effects: cough, chest pain, difficult/painful breathing.||
6135|083|S|   A very serious allergic reaction to this drug is rare.||
6135|084|S|However, get medical help right away if you notice any symptoms||
6135|085|S|of a serious allergic reaction, including: rash, itching/swelling||
6135|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6135|087|S|breathing.||
6135|088|S|   This is not a complete list of possible side effects. If you||
6135|089|S|notice other effects not listed above, contact your doctor or||
6135|090|S|pharmacist.||
6135|091|S|   In the US -||
6135|092|S|   Call your doctor for medical advice about side effects. You||
6135|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6135|094|S|www.fda.gov/medwatch.||
6135|095|S|   In Canada - Call your doctor for medical advice about side||
6135|096|S|effects. You may report side effects to Health Canada at||
6135|097|S|1-866-234-2345.||
6135|098|B|||
6135|099|P|PRECAUTIONS:  Before taking lomustine, tell your doctor or||
6135|100|P|pharmacist if you are allergic to it; or if you have any other||
6135|101|P|allergies. This product may contain inactive ingredients, which||
6135|102|P|can cause allergic reactions or other problems. Talk to your||
6135|103|P|pharmacist for more details.||
6135|104|P|   Before using this medication, tell your doctor or pharmacist||
6135|105|P|your medical history, especially of: current infection, blood||
6135|106|P|disorder (such as anemia, clotting problem), kidney disease,||
6135|107|P|liver disease, lung disease.||
6135|108|P|   Lomustine can make you more likely to get infections or may||
6135|109|P|make current infections worse. Stay away from anyone who has an||
6135|110|P|infection that may easily spread (such as chickenpox, COVID-19,||
6135|111|P|measles, flu). Talk to your doctor if you have been exposed to an||
6135|112|P|infection or for more details.||
6135|113|P|   Tell your health care professional that you are using||
6135|114|P|lomustine before having any immunizations/vaccinations. Avoid||
6135|115|P|contact with people who have recently received live vaccines||
6135|116|P|(such as flu vaccine inhaled through the nose).||
6135|117|P|   To lower the chance of getting cut, bruised, or injured, use||
6135|118|P|caution with sharp objects like razors and nail cutters, and||
6135|119|P|avoid activities such as contact sports.||
6135|120|P|   Before having surgery, tell your doctor or dentist about all||
6135|121|P|the products you use (including prescription drugs,||
6135|122|P|nonprescription drugs, and herbal products).||
6135|123|P|   Tell your doctor if you are pregnant or plan to become||
6135|124|P|pregnant. You should not become pregnant while using lomustine.||
6135|125|P|Lomustine may harm an unborn baby. Women using this medication||
6135|126|P|should ask about reliable forms of birth control during treatment||
6135|127|P|and for 2 weeks after the last dose. Men using this medication||
6135|128|P|should ask about reliable forms of birth control during treatment||
6135|129|P|and for 4 months after the last dose. If you or your partner||
6135|130|P|becomes pregnant, talk to your doctor right away about the risks||
6135|131|P|and benefits of this medication.||
6135|132|P|   Since this drug can be absorbed through the skin and lungs and||
6135|133|P|may harm an unborn baby, women who are pregnant or who may become||
6135|134|P|pregnant should not handle this medication or breathe the dust||
6135|135|P|from the capsules.||
6135|136|P|   It is unknown if this drug passes into breast milk. Because of||
6135|137|P|the possible risk to the infant, breastfeedingis not recommended||
6135|138|P|while using this drug and for 2 weeks after the last dose.||
6135|139|P|Consult your doctor before breastfeeding.||
6135|140|B|||
6135|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6135|142|I|medications work or increase your risk for serious side effects.||
6135|143|I|This document does not contain all possible drug interactions.||
6135|144|I|Keep a list of all the products you use (including||
6135|145|I|prescription/nonprescription drugs and herbal products) and share||
6135|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
6135|147|I|the dosage of any medicines without your doctor's approval.||
6135|148|B|||
6135|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6135|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6135|151|O|poison control center right away. US residents can call||
6135|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6135|153|B|||
6135|154|N|NOTES:  Do not share this medication with others.||
6135|155|N|   Lab and/or medical tests (such as complete blood count,||
6135|156|N|kidney/liver/lung tests) should be done while you are taking this||
6135|157|N|medication. Keep all medical and lab appointments. Consult your||
6135|158|N|doctor for more details.||
6135|159|B|||
6135|160|D|MISSED DOSE:  It is important to take each dose of this||
6135|161|D|medication as scheduled. If you miss a dose, ask your doctor or||
6135|162|D|pharmacist right away for a new dosing schedule. Do not double||
6135|163|D|the dose to catch up.||
6135|164|B|||
6135|165|R|STORAGE:  Store at room temperature away from light and moisture.||
6135|166|R|Avoid too much heat. Do not store in the bathroom. Keep all||
6135|167|R|medications away from children and pets.||
6135|168|R|   Do not flush medications down the toilet or pour them into a||
6135|169|R|drain unless instructed to do so. Properly discard this product||
6135|170|R|when it is expired or no longer needed. Consult your pharmacist||
6135|171|R|or local waste disposal company.||
6135|172|B|||
6135|173|M|MEDICAL ALERT:  Your condition can cause complications in a||
6135|174|M|medical emergency. For information about enrolling in MedicAlert,||
6135|175|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6135|176|B|||
6135|177|A|Information last revised September 2024.||
6135|178|A|Copyright(c) 2025 First Databank, Inc.||
6135|179|B|||
6136|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6136|002|Z|does NOT have all possible information about this product. This||
6136|003|Z|information does not assure that this product is safe, effective,||
6136|004|Z|or appropriate for you. This information is not individual||
6136|005|Z|medical advice and does not substitute for the advice of your||
6136|006|Z|health care professional. Always ask your health care||
6136|007|Z|professional for complete information about this product and your||
6136|008|Z|specific health needs.||
6136|009|B|||
6136|010|T|CARMUSTINE - INJECTION||
6136|011|F|(kar-MUS-teen)||
6136|012|B|||
6136|013|C|COMMON BRAND NAME(S): BiCNU||
6136|014|B|||
6136|015|W|WARNING:  Carmustine may cause serious bleeding/blood problems.||
6136|016|W|This effect can cause anemia, lower your body's ability to fight||
6136|017|W|an infection, or cause your body to bruise or bleed more easily.||
6136|018|W|Your doctor will check you closely during and for at least 6||
6136|019|W|weeks after treatment to lessen the chance of serious side||
6136|020|W|effects. Tell your doctor right away if you develop symptoms such||
6136|021|W|as easy bruising/bleeding, unusual tiredness, signs of infection||
6136|022|W|(such as sore throat that doesn't go away, fever, chills).||
6136|023|W|   This medication may also cause very serious (possibly fatal)||
6136|024|W|lung problems. The risk increases after receiving higher total||
6136|025|W|doses and can occur years after treatment. Tell your doctor right||
6136|026|W|away if you develop symptoms such as cough that doesn't go away,||
6136|027|W|shortness of breath, chest pain, unusual weakness/tiredness.||
6136|028|B|||
6136|029|U|USES:  This medication is used to treat certain types of cancer||
6136|030|U|(including multiple myeloma, brain tumor, Hodgkin's disease,||
6136|031|U|non-Hodgkin's lymphoma). Carmustine belongs to a class of drugs||
6136|032|U|known as alkylating agents. It works by slowing or stopping the||
6136|033|U|growth of cancer cells.||
6136|034|B|||
6136|035|H|HOW TO USE:  This medication is given by slow injection into a||
6136|036|H|vein by a health care professional. It is given as directed by||
6136|037|H|your doctor, usually every 6 weeks. The dosage is based on your||
6136|038|H|medical condition, body size, and response to treatment.||
6136|039|B|||
6136|040|S|SIDE EFFECTS:  See also Warning section.||
6136|041|S|   Nausea, vomiting, loss of appetite, headache, flushing, eye||
6136|042|S|redness, or pain at the injection site may occur. Nausea and||
6136|043|S|vomiting can be severe. In some cases, your doctor may prescribe||
6136|044|S|medication to prevent or relieve nausea and vomiting. Eating||
6136|045|S|several small meals, not eating before treatment, or limiting||
6136|046|S|activity may help lessen some of these effects. If any of these||
6136|047|S|effects last or get worse, tell your doctor or pharmacist||
6136|048|S|promptly.||
6136|049|S|   People using this medication may have serious side effects.||
6136|050|S|However, you have been prescribed this drug because your doctor||
6136|051|S|has judged that the benefit to you is greater than the risk of||
6136|052|S|side effects. Careful monitoring by your doctor may decrease your||
6136|053|S|risk.||
6136|054|S|   Tell your doctor right away if you have any serious side||
6136|055|S|effects, including: signs of kidney problems (such as change in||
6136|056|S|the amount of urine), signs of liver problems (such as||
6136|057|S|nausea/vomiting that doesn't stop, loss of appetite,||
6136|058|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), vision||
6136|059|S|changes.||
6136|060|S|   People who are treated with this medication may rarely get||
6136|061|S|other cancers. Consult your doctor for more details.||
6136|062|S|   A very serious allergic reaction to this drug is rare.||
6136|063|S|However, get medical help right away if you notice any symptoms||
6136|064|S|of a serious allergic reaction, including: rash, itching/swelling||
6136|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6136|066|S|breathing.||
6136|067|S|   This is not a complete list of possible side effects. If you||
6136|068|S|notice other effects not listed above, contact your doctor or||
6136|069|S|pharmacist.||
6136|070|S|   In the US -||
6136|071|S|   Call your doctor for medical advice about side effects. You||
6136|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6136|073|S|www.fda.gov/medwatch.||
6136|074|S|   In Canada - Call your doctor for medical advice about side||
6136|075|S|effects. You may report side effects to Health Canada at||
6136|076|S|1-866-234-2345.||
6136|077|B|||
6136|078|P|PRECAUTIONS:  Before using carmustine, tell your doctor or||
6136|079|P|pharmacist if you are allergic to it; or if you have any other||
6136|080|P|allergies. This product may contain inactive ingredients, which||
6136|081|P|can cause allergic reactions or other problems. Talk to your||
6136|082|P|pharmacist for more details.||
6136|083|P|   Before using this medication, tell your doctor or pharmacist||
6136|084|P|your medical history, especially of: bleeding/blood problems,||
6136|085|P|current/recent/returning infection, kidney disease, liver||
6136|086|P|problems, lung disease.||
6136|087|P|   Carmustine can make you more likely to get infections or may||
6136|088|P|make current infections worse. Stay away from anyone who has an||
6136|089|P|infection that may easily spread (such as chickenpox, COVID-19,||
6136|090|P|measles, flu). Talk to your doctor if you have been exposed to an||
6136|091|P|infection or for more details.||
6136|092|P|   Tell your health care professional that you are using||
6136|093|P|carmustine before having any immunizations/vaccinations. Avoid||
6136|094|P|contact with people who have recently received live vaccines||
6136|095|P|(such as flu vaccine inhaled through the nose).||
6136|096|P|   To lower the chance of getting cut, bruised, or injured, use||
6136|097|P|caution with sharp objects like razors and nail cutters, and||
6136|098|P|avoid activities such as contact sports.||
6136|099|P|   Before having surgery, tell your doctor or dentist about all||
6136|100|P|the products you use (including prescription drugs,||
6136|101|P|nonprescription drugs, and herbal products).||
6136|102|P|   Children may be at greater risk for developing serious lung||
6136|103|P|problems after receiving this medication.||
6136|104|P|   Tell your doctor if you are pregnant or plan to become||
6136|105|P|pregnant. You should not become pregnant while using carmustine.||
6136|106|P|Carmustine may harm an unborn baby. Women using this medication||
6136|107|P|should ask about reliable forms of birth control during treatment||
6136|108|P|and for 6 months after the last dose. Men using this medication||
6136|109|P|should ask about reliable forms of birth control during treatment||
6136|110|P|and for 3 months after the last dose. If you or your partner||
6136|111|P|becomes pregnant, talk to your doctor right away about the risks||
6136|112|P|and benefits of this medication.||
6136|113|P|   It is unknown if this drug passes into breast milk. Because of||
6136|114|P|the possible risk to the infant, breastfeeding is not recommended||
6136|115|P|while using this drug. Consult your doctor before breastfeeding.||
6136|116|B|||
6136|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6136|118|I|medications work or increase your risk for serious side effects.||
6136|119|I|This document does not contain all possible drug interactions.||
6136|120|I|Keep a list of all the products you use (including||
6136|121|I|prescription/nonprescription drugs and herbal products) and share||
6136|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
6136|123|I|the dosage of any medicines without your doctor's approval.||
6136|124|B|||
6136|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6136|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6136|127|O|poison control center right away. US residents can call||
6136|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6136|129|B|||
6136|130|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
6136|131|N|kidney/liver/lung function) should be done while you are using||
6136|132|N|this medication. Keep all medical and lab appointments.||
6136|133|B|||
6136|134|D|MISSED DOSE:  It is important to get each dose of this medication||
6136|135|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6136|136|D|right away for a new dosing schedule.||
6136|137|B|||
6136|138|R|STORAGE:  Not applicable. This medication is given in a clinic||
6136|139|R|and will not be stored at home.||
6136|140|B|||
6136|141|M|MEDICAL ALERT:  Your condition can cause complications in a||
6136|142|M|medical emergency. For information about enrolling in MedicAlert,||
6136|143|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6136|144|B|||
6136|145|A|Information last revised May 2024.||
6136|146|A|Copyright(c) 2025 First Databank, Inc.||
6136|147|B|||
6137|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6137|002|Z|does NOT have all possible information about this product. This||
6137|003|Z|information does not assure that this product is safe, effective,||
6137|004|Z|or appropriate for you. This information is not individual||
6137|005|Z|medical advice and does not substitute for the advice of your||
6137|006|Z|health care professional. Always ask your health care||
6137|007|Z|professional for complete information about this product and your||
6137|008|Z|specific health needs.||
6137|009|B|||
6137|010|T|LEUPROLIDE - INJECTION||
6137|011|F|(LOO-proe-lide)||
6137|012|B|||
6137|013|C|COMMON BRAND NAME(S): Lupron||
6137|014|B|||
6137|015|U|USES:  Leuprolide is used to treat advanced prostate cancer. It||
6137|016|U|is not a cure. Most types of prostate cancer need the hormone||
6137|017|U|testosterone to grow and spread. Leuprolide works by reducing the||
6137|018|U|amount of testosterone that the body makes. This helps slow or||
6137|019|U|stop the growth of cancer cells and helps relieve symptoms such||
6137|020|U|as painful/difficult urination. Talk to your doctor about the||
6137|021|U|risks and benefits of treatment.||
6137|022|U|   Leuprolide is also used to stop early puberty (precocious||
6137|023|U|puberty) in children. It helps to delay sexual development (such||
6137|024|U|as growth of the breasts/testicles) and the start of menstrual||
6137|025|U|periods. It also helps slow down early bone growth to increase||
6137|026|U|the likelihood of reaching normal adult height. Leuprolide works||
6137|027|U|by decreasing the amount of sex hormones that a child's body||
6137|028|U|makes (estrogen in girls, testosterone in boys).||
6137|029|B|||
6137|030|V|OTHER USES:  This section contains uses of this drug that are not||
6137|031|V|listed in the approved professional labeling for the drug but||
6137|032|V|that may be prescribed by your health care professional. Use this||
6137|033|V|drug for a condition that is listed in this section only if it||
6137|034|V|has been so prescribed by your health care professional.||
6137|035|V|   This drug may also be used for ovarian cancer.||
6137|036|B|||
6137|037|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
6137|038|H|provided by your pharmacist before you start using leuprolide and||
6137|039|H|each time you get a refill. Ask your health care professional how||
6137|040|H|to prepare and use this medication. If you have any questions,||
6137|041|H|ask your doctor or pharmacist.||
6137|042|H|   Inject this medication under the skin as directed by your||
6137|043|H|doctor, usually once a day.||
6137|044|H|   Children's dosage is based on weight and response to||
6137|045|H|treatment. The doctor should consider stopping treatment before||
6137|046|H|age 11 for girls and age 12 for boys. Consult the doctor for||
6137|047|H|details.||
6137|048|H|    Before using, check this product for particles or||
6137|049|H|discoloration. If either is present, do not use the liquid.||
6137|050|H|Before injecting each dose, clean the skin you are going to||
6137|051|H|inject into (the injection site) with rubbing alcohol. Change the||
6137|052|H|injection site each time to lessen injury under the skin. To||
6137|053|H|lessen bruising, do not rub the injection site after a shot.||
6137|054|H|Learn how to store and discard medical supplies safely.||
6137|055|H|   Use this medication regularly to get the most benefit from it.||
6137|056|H|To help you remember, use it at the same time each day.||
6137|057|H|   During the first few weeks of treatment, your hormone levels||
6137|058|H|will actually go up before they go down. This is a normal||
6137|059|H|response to this medication. Your symptoms may get worse for a||
6137|060|H|few weeks.||
6137|061|H|   If you have prostate cancer that has spread to the spine or||
6137|062|H|caused urinary blockage, you may require closer monitoring by||
6137|063|H|your doctor, especially when you first start treatment. Tell your||
6137|064|H|doctor right away if you have any bone pain,||
6137|065|H|numbness/tingling/weakness of the arms/legs, blood in the urine,||
6137|066|H|painful/difficult urination, unusual weakness, or inability to||
6137|067|H|move.||
6137|068|H|   If you are using this medication to stop early puberty, you||
6137|069|H|may notice worsening symptoms (such as menstrual periods) at the||
6137|070|H|start of treatment. However, you should see an improvement in||
6137|071|H|symptoms usually within 1 to 2 months. Tell the doctor promptly||
6137|072|H|if new or worsened symptoms develop after starting treatment.||
6137|073|B|||
6137|074|S|SIDE EFFECTS:  Mild burning/pain/bruising at the injection site,||
6137|075|S|hot flashes (flushing), increased sweating, night sweats,||
6137|076|S|tiredness, headache, upset stomach, breast changes, acne,||
6137|077|S|joint/muscle aches, trouble sleeping, reduced sexual interest,||
6137|078|S|vaginal discomfort/dryness, vaginal bleeding, swelling of the||
6137|079|S|ankles/feet, increased urination at night, or dizziness may||
6137|080|S|occur. If any of these effects last or get worse, tell your||
6137|081|S|doctor or pharmacist promptly.||
6137|082|S|   Rarely in men, shrinking of the testicles, breast||
6137|083|S|tenderness/swelling, and reduced sexual interest/ability may also||
6137|084|S|occur as a result of lowered testosterone levels. Talk to your||
6137|085|S|doctor if these effects occur.||
6137|086|S|   In girls, when this medication is used regularly, it is||
6137|087|S|expected that the menstrual period will stop or decrease to light||
6137|088|S|bleeding/spotting during the first 2 months. Tell the doctor||
6137|089|S|promptly if regular periods continue after 2 months of treatment||
6137|090|S|with leuprolide.||
6137|091|S|   Remember that this medication has been prescribed because your||
6137|092|S|doctor has judged that the benefit to you is greater than the||
6137|093|S|risk of side effects. Many people using this medication do not||
6137|094|S|have serious side effects.||
6137|095|S|   Tell your doctor right away if any of these serious side||
6137|096|S|effects occur: new/worsening bone pain (in adults), easily broken||
6137|097|S|bones (in adults), increased thirst/urination (in adults),||
6137|098|S|mental/mood changes (such as depression, thoughts of suicide,||
6137|099|S|mood swings, aggression).||
6137|100|S|   In adults, leuprolide may rarely cause serious liver disease.||
6137|101|S|Tell your doctor right away if you develop signs of liver||
6137|102|S|disease, such as nausea/vomiting that doesn't stop, loss of||
6137|103|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
6137|104|S|urine.||
6137|105|S|   In adults, this medication may rarely cause heart problems and||
6137|106|S|stroke. Get medical help right away if any of these very serious||
6137|107|S|side effects occur: symptoms of a heart attack (such as||
6137|108|S|chest/jaw/left arm pain, shortness of breath, unusual sweating),||
6137|109|S|signs of a stroke (such as weakness on one side of the body,||
6137|110|S|trouble speaking, sudden vision changes, confusion),||
6137|111|S|fast/irregular heartbeat, severe dizziness, fainting.||
6137|112|S|   Get medical help right away if any of these very serious side||
6137|113|S|effects occur: seizures.||
6137|114|S|   Children using leuprolide may be at risk for increased||
6137|115|S|pressure around the brain (intracranial hypertension). Get||
6137|116|S|medical help right away if your child has any of these very||
6137|117|S|serious side effects: nausea/vomiting that doesn't stop, headache||
6137|118|S|that is severe or doesn't go away, eye pain, vision changes (such||
6137|119|S|as blurred/double vision, decreased vision), ringing in the ears.||
6137|120|S|   A very serious allergic reaction to this drug is rare.||
6137|121|S|However, get medical help right away if you notice any symptoms||
6137|122|S|of a serious allergic reaction, including: fever, swollen lymph||
6137|123|S|nodes, rash, itching/swelling (especially of the||
6137|124|S|face/tongue/throat), severe dizziness, trouble breathing.||
6137|125|S|   This is not a complete list of possible side effects. If you||
6137|126|S|notice other effects not listed above, contact your doctor or||
6137|127|S|pharmacist.||
6137|128|S|   In the US -||
6137|129|S|   Call your doctor for medical advice about side effects. You||
6137|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6137|131|S|www.fda.gov/medwatch.||
6137|132|S|   In Canada - Call your doctor for medical advice about side||
6137|133|S|effects. You may report side effects to Health Canada at||
6137|134|S|1-866-234-2345.||
6137|135|B|||
6137|136|P|PRECAUTIONS:  Before using leuprolide, tell your doctor or||
6137|137|P|pharmacist if you are allergic to it; or to similar drugs (such||
6137|138|P|as histrelin, triptorelin); or of any other allergies. This||
6137|139|P|product may contain inactive ingredients (such as benzyl||
6137|140|P|alcohol), which can cause allergic reactions or other problems.||
6137|141|P|Talk to your pharmacist for more details.||
6137|142|P|   Before using this medication, tell your doctor or pharmacist||
6137|143|P|your medical history, especially of: diabetes, heart disease||
6137|144|P|(such as heart attack), stroke, high cholesterol, mental/mood||
6137|145|P|problems (such as depression), seizures.||
6137|146|P|   In adults, leuprolide may weaken your bones and increase your||
6137|147|P|risk for bone loss (osteoporosis) if used for a long time. Before||
6137|148|P|using this medication, tell your doctor or pharmacist if you have||
6137|149|P|osteoporosis or if you have any of the following risk factors for||
6137|150|P|osteoporosis: long-term alcohol use, smoking, family history of||
6137|151|P|osteoporosis and broken bones, use of certain medications (for||
6137|152|P|example, corticosteroids such as prednisone, certain anti-seizure||
6137|153|P|drugs such as phenytoin).||
6137|154|P|   In adults, leuprolide may cause a condition that affects the||
6137|155|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
6137|156|P|serious (rarely fatal) fast/irregular heartbeat and other||
6137|157|P|symptoms (such as severe dizziness, fainting) that need medical||
6137|158|P|attention right away.||
6137|159|P|   The risk of QT prolongation may be increased if you have||
6137|160|P|certain medical conditions or are taking other drugs that may||
6137|161|P|cause QT prolongation. Before using leuprolide, tell your doctor||
6137|162|P|or pharmacist of all the drugs you take and if you have any of||
6137|163|P|the following conditions: certain heart problems (heart failure,||
6137|164|P|slow heartbeat, QT prolongation in the EKG), family history of||
6137|165|P|certain heart problems (QT prolongation in the EKG, sudden||
6137|166|P|cardiac death).||
6137|167|P|   Low levels of potassium or magnesium in the blood may also||
6137|168|P|increase your risk of QT prolongation. This risk may increase if||
6137|169|P|you use certain drugs (such as diuretics/"water pills") or if you||
6137|170|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6137|171|P|Talk to your doctor about using leuprolide safely.||
6137|172|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6137|173|P|can make you more dizzy. Do not drive, use machinery, or do||
6137|174|P|anything that needs alertness until you can do it safely. Limit||
6137|175|P|alcoholic beverages. Talk to your doctor if you are using||
6137|176|P|marijuana (cannabis).||
6137|177|P|   Before having surgery, tell your doctor or dentist about all||
6137|178|P|the products you use (including prescription drugs,||
6137|179|P|nonprescription drugs, and herbal products).||
6137|180|P|   Older adults may be more sensitive to the side effects of this||
6137|181|P|drug, especially QT prolongation (see above).||
6137|182|P|   This medication can affect fertility in males. Ask your doctor||
6137|183|P|for more details.||
6137|184|P|   This medication must not be used during pregnancy. It may harm||
6137|185|P|an unborn baby. It is important to prevent pregnancy while using||
6137|186|P|this medication. Consult your doctor for more details and to||
6137|187|P|discuss using reliable forms of non-hormonal birth control (such||
6137|188|P|as condoms, diaphragm with spermicide) while using this||
6137|189|P|medication. If you become pregnant or think you may be pregnant,||
6137|190|P|tell your doctor right away.||
6137|191|P|   It is unknown if leuprolide passes into breast milk. Because||
6137|192|P|of the possible risk to the infant, breastfeeding is not||
6137|193|P|recommended while using this medication. Consult your doctor||
6137|194|P|before breastfeeding.||
6137|195|B|||
6137|196|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6137|197|I|medications work or increase your risk for serious side effects.||
6137|198|I|This document does not contain all possible drug interactions.||
6137|199|I|Keep a list of all the products you use (including||
6137|200|I|prescription/nonprescription drugs and herbal products) and share||
6137|201|I|it with your doctor and pharmacist. Do not start, stop, or change||
6137|202|I|the dosage of any medicines without your doctor's approval.||
6137|203|I|   This medication may interfere with certain lab tests, possibly||
6137|204|I|causing false test results. Make sure lab personnel and all your||
6137|205|I|doctors know you use this drug.||
6137|206|B|||
6137|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6137|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6137|209|O|poison control center right away. US residents can call||
6137|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6137|211|B|||
6137|212|N|NOTES:  Do not share this medication with others.||
6137|213|N|   Lab and/or medical tests (such as hormone levels, PSA blood||
6137|214|N|test for men, blood glucose, cholesterol/triglyceride levels,||
6137|215|N|height measurements for children) should be done while you are||
6137|216|N|using this medication. Keep all medical and lab appointments.||
6137|217|N|Consult your doctor for more details.||
6137|218|B|||
6137|219|D|MISSED DOSE:  It is important to get each dose of this medication||
6137|220|D|as scheduled. If a dose is missed, ask the doctor or pharmacist||
6137|221|D|right away for a new dosing schedule. Do not double the dose to||
6137|222|D|catch up.||
6137|223|B|||
6137|224|R|STORAGE:  Different brands of this medication have different||
6137|225|R|storage needs. Check the product package for instructions on how||
6137|226|R|to store your brand, or ask your pharmacist. Protect from light||
6137|227|R|and freezing. Keep all medications away from children and pets.||
6137|228|R|   Do not flush medications down the toilet or pour them into a||
6137|229|R|drain unless instructed to do so. Properly discard this product||
6137|230|R|when it is expired or no longer needed. Consult your pharmacist||
6137|231|R|or local waste disposal company.||
6137|232|B|||
6137|233|A|Information last revised September 2024.||
6137|234|A|Copyright(c) 2025 First Databank, Inc.||
6137|235|B|||
6138|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6138|002|Z|does NOT have all possible information about this product. This||
6138|003|Z|information does not assure that this product is safe, effective,||
6138|004|Z|or appropriate for you. This information is not individual||
6138|005|Z|medical advice and does not substitute for the advice of your||
6138|006|Z|health care professional. Always ask your health care||
6138|007|Z|professional for complete information about this product and your||
6138|008|Z|specific health needs.||
6138|009|B|||
6138|010|T|FAMCICLOVIR - ORAL||
6138|011|F|(fam-SYE-kloe-vir)||
6138|012|B|||
6138|013|C|COMMON BRAND NAME(S): Famvir||
6138|014|B|||
6138|015|U|USES:  Famciclovir is used to treat infections caused by certain||
6138|016|U|types of viruses. It treats shingles caused by herpes zoster. It||
6138|017|U|also treats outbreaks of herpes simplex that cause cold sores||
6138|018|U|around the mouth, sores around the anus, and genital herpes. In||
6138|019|U|people with frequent outbreaks of genital herpes, famciclovir is||
6138|020|U|used to help reduce the number of future episodes.||
6138|021|U|   Famciclovir is an antiviral drug. However, it is not a cure||
6138|022|U|for these infections. The viruses that cause these infections||
6138|023|U|continue to live in the body even between outbreaks. Famciclovir||
6138|024|U|decreases the severity and length of these outbreaks. It helps||
6138|025|U|the sores heal faster, keeps new sores from forming, and||
6138|026|U|decreases pain/itching. This medication may also help reduce how||
6138|027|U|long pain remains after the sores heal. In addition, in people||
6138|028|U|with a weakened immune system, famciclovir can decrease the risk||
6138|029|U|of the virus spreading to other parts of the body and causing||
6138|030|U|serious infections.||
6138|031|B|||
6138|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6138|033|H|from your pharmacist before you start taking famciclovir and each||
6138|034|H|time you get a refill. If you have any questions, ask your doctor||
6138|035|H|or pharmacist.||
6138|036|H|   Take this medication by mouth with or without food as directed||
6138|037|H|by your doctor, usually 2 to 3 times a day.||
6138|038|H|   This medication works best when started at the first sign of||
6138|039|H|an outbreak, as directed by your doctor. It may not work as well||
6138|040|H|if you delay treatment.||
6138|041|H|   The dosage is based on your medical condition and response to||
6138|042|H|treatment.||
6138|043|H|   This medication works best when the amount of drug in your||
6138|044|H|body is kept at a constant level. Take this drug at evenly spaced||
6138|045|H|intervals. To help you remember, take it at the same times each||
6138|046|H|day.||
6138|047|H|   Continue to take this medication until the full prescribed||
6138|048|H|amount is finished. Do not change your dose, skip any doses, or||
6138|049|H|stop this medication early without your doctor's approval.||
6138|050|H|   Tell your doctor if your condition lasts or gets worse.||
6138|051|B|||
6138|052|S|SIDE EFFECTS:  Headache, nausea, and diarrhea may occur. If any||
6138|053|S|of these effects last or get worse, tell your doctor or||
6138|054|S|pharmacist promptly.||
6138|055|S|   Remember that this medication has been prescribed because your||
6138|056|S|doctor has judged that the benefit to you is greater than the||
6138|057|S|risk of side effects. Many people using this medication do not||
6138|058|S|have serious side effects.||
6138|059|S|   Tell your doctor right away if you have any serious side||
6138|060|S|effects, including: mental/mood changes (such as agitation,||
6138|061|S|slowed thinking, confusion, hallucinations), dizziness,||
6138|062|S|drowsiness, signs of kidney problems (such as change in the||
6138|063|S|amount of urine), yellowing eyes/skin, easy bruising/bleeding.||
6138|064|S|   A very serious allergic reaction to this drug is rare.||
6138|065|S|However, get medical help right away if you notice any symptoms||
6138|066|S|of a serious allergic reaction, including: rash, itching/swelling||
6138|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6138|068|S|breathing.||
6138|069|S|   This is not a complete list of possible side effects. If you||
6138|070|S|notice other effects not listed above, contact your doctor or||
6138|071|S|pharmacist.||
6138|072|S|   In the US -||
6138|073|S|   Call your doctor for medical advice about side effects. You||
6138|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6138|075|S|www.fda.gov/medwatch.||
6138|076|S|   In Canada - Call your doctor for medical advice about side||
6138|077|S|effects. You may report side effects to Health Canada at||
6138|078|S|1-866-234-2345.||
6138|079|B|||
6138|080|P|PRECAUTIONS:  Before taking famciclovir, tell your doctor or||
6138|081|P|pharmacist if you are allergic to it; or to penciclovir; or if||
6138|082|P|you have any other allergies. This product may contain inactive||
6138|083|P|ingredients, which can cause allergic reactions or other||
6138|084|P|problems. Talk to your pharmacist for more details.||
6138|085|P|   Before using this medication, tell your doctor or pharmacist||
6138|086|P|your medical history, especially of: kidney problems.||
6138|087|P|   This drug may rarely make you dizzy or drowsy. Alcohol or||
6138|088|P|marijuana (cannabis) can make you more dizzy or drowsy. Do not||
6138|089|P|drive, use machinery, or do anything that needs alertness until||
6138|090|P|you can do it safely. Limit alcoholic beverages. Talk to your||
6138|091|P|doctor if you are using marijuana (cannabis).||
6138|092|P|   This medication may contain lactose. If you have certain||
6138|093|P|conditions such as galactose intolerance, severe lactase||
6138|094|P|deficiency (not lactose or milk intolerance), or||
6138|095|P|glucose-galactose malabsorption that require you to restrict your||
6138|096|P|intake of lactose, consult your doctor or pharmacist before||
6138|097|P|taking this medication.||
6138|098|P|   Before having surgery, tell your doctor or dentist about all||
6138|099|P|the products you use (including prescription drugs,||
6138|100|P|nonprescription drugs, and herbal products).||
6138|101|P|   Do not have certain immunizations/vaccinations (such as||
6138|102|P|vaccines against the varicella virus) without the consent of your||
6138|103|P|doctor.||
6138|104|P|   Older adults may be more sensitive to the side effects of this||
6138|105|P|drug, especially dizziness, drowsiness, confusion, and change in||
6138|106|P|the amount of urine (kidney problems).||
6138|107|P|   Famciclovir does not protect against the spread of genital||
6138|108|P|herpes. To lower the chance of giving herpes to your partner, do||
6138|109|P|not have sexual contact during an outbreak or if you have||
6138|110|P|symptoms. You can spread genital herpes even if you do not have||
6138|111|P|symptoms. Always use an effective barrier method (latex or||
6138|112|P|polyurethane condoms/dental dams) during all sexual activity.||
6138|113|P|Consult your doctor or pharmacist for more details.||
6138|114|P|   During pregnancy, this medication should be used only when||
6138|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
6138|116|P|   It is unknown if this medication passes into breast milk. It||
6138|117|P|may have undesirable effects on a nursing infant. Consult your||
6138|118|P|doctor before breastfeeding.||
6138|119|B|||
6138|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6138|121|I|medications work or increase your risk for serious side effects.||
6138|122|I|This document does not contain all possible drug interactions.||
6138|123|I|Keep a list of all the products you use (including||
6138|124|I|prescription/nonprescription drugs and herbal products) and share||
6138|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
6138|126|I|the dosage of any medicines without your doctor's approval.||
6138|127|B|||
6138|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6138|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6138|130|O|poison control center right away. US residents can call||
6138|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6138|132|B|||
6138|133|N|NOTES:  Do not share this medication with others.||
6138|134|N|   This medication has been prescribed for your current condition||
6138|135|N|only. Do not use it later for another infection unless your||
6138|136|N|doctor tells you to.||
6138|137|B|||
6138|138|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6138|139|D|remember. If it is near the time of the next dose, skip the||
6138|140|D|missed dose. Take your next dose at the regular time. Do not||
6138|141|D|double the dose to catch up.||
6138|142|B|||
6138|143|R|STORAGE:  Store at room temperature away from light and moisture.||
6138|144|R|Do not store in the bathroom. Keep all medications away from||
6138|145|R|children and pets.||
6138|146|R|   Do not flush medications down the toilet or pour them into a||
6138|147|R|drain unless instructed to do so. Properly discard this product||
6138|148|R|when it is expired or no longer needed. Consult your pharmacist||
6138|149|R|or local waste disposal company.||
6138|150|B|||
6138|151|A|Information last revised May 2024.||
6138|152|A|Copyright(c) 2025 First Databank, Inc.||
6138|153|B|||
6141|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6141|002|Z|does NOT have all possible information about this product. This||
6141|003|Z|information does not assure that this product is safe, effective,||
6141|004|Z|or appropriate for you. This information is not individual||
6141|005|Z|medical advice and does not substitute for the advice of your||
6141|006|Z|health care professional. Always ask your health care||
6141|007|Z|professional for complete information about this product and your||
6141|008|Z|specific health needs.||
6141|009|B|||
6141|010|T|TOBRAMYCIN SOLUTION - INHALATION||
6141|011|F|(TOE-bra-MYE-sin)||
6141|012|B|||
6141|013|C|COMMON BRAND NAME(S): Bethkis, Kitabis Pak, Tobi||
6141|014|B|||
6141|015|U|USES:  This medication is used to treat people with a certain||
6141|016|U|inherited condition (cystic fibrosis) who have an ongoing lung||
6141|017|U|infection with a certain bacteria (Pseudomonas aeruginosa).||
6141|018|U|People with cystic fibrosis produce thick, sticky mucus that can||
6141|019|U|plug up the tubes, ducts and passageways in the lungs. This can||
6141|020|U|result in serious breathing problems and infections in the lungs.||
6141|021|U|   Tobramycin belongs to a class of drugs known as aminoglycoside||
6141|022|U|antibiotics. Tobramycin inhalation solution works by stopping the||
6141|023|U|growth of a certain bacteria (Pseudomonas aeruginosa) that||
6141|024|U|commonly infects the lungs of people with cystic fibrosis. This||
6141|025|U|effect decreases lung infections and damage, and helps to improve||
6141|026|U|breathing.||
6141|027|B|||
6141|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6141|029|H|from your pharmacist before you start using this medication and||
6141|030|H|each time you get a refill. This medication is used with a||
6141|031|H|special machine called a nebulizer that changes the solution to a||
6141|032|H|fine mist that you inhale. Learn and follow all instructions for||
6141|033|H|the use of this medication and the nebulizer. Children may need||
6141|034|H|help from an adult to use this medication properly. If you have||
6141|035|H|any questions, ask your doctor, pharmacist, or respiratory||
6141|036|H|therapist.||
6141|037|H|   Use this medication with the nebulizer as directed by your||
6141|038|H|doctor, usually every 12 hours. Each treatment lasts about 15||
6141|039|H|minutes. This medicine is usually used for 28 days in a row,||
6141|040|H|followed by 28 days without this medication, repeating the cycle||
6141|041|H|until your doctor directs you to stop.||
6141|042|H|   Each ampule of tobramycin is for one-time use. Inspect each||
6141|043|H|ampule before use. Normal solution is slightly yellow and may||
6141|044|H|darken with age. Discard the ampule if the solution is cloudy or||
6141|045|H|has particles in it, or if it has expired or has been stored at||
6141|046|H|room temperature for longer than 28 days. Use all of the contents||
6141|047|H|of the ampule for each dose. Do not mix tobramycin with any other||
6141|048|H|medicines in the nebulizer.||
6141|049|H|   For the best effect, use this antibiotic at evenly spaced||
6141|050|H|times. To help you remember, use this medication at the same||
6141|051|H|time(s) every day.||
6141|052|H|   Continue to take this medication until the full prescribed||
6141|053|H|amount is finished, even if symptoms disappear after a few days.||
6141|054|H|Stopping the medication too early may result in a return of the||
6141|055|H|infection.||
6141|056|H|   Tell your doctor if your condition does not get better or if||
6141|057|H|it gets worse.||
6141|058|B|||
6141|059|S|SIDE EFFECTS:  Hoarseness and changes in voice may occur. If any||
6141|060|S|of these effects last or get worse, tell your doctor or||
6141|061|S|pharmacist promptly.||
6141|062|S|   Remember that this medication has been prescribed because your||
6141|063|S|doctor has judged that the benefit to you is greater than the||
6141|064|S|risk of side effects. Many people using this medication do not||
6141|065|S|have serious side effects.||
6141|066|S|   Tell your doctor right away if you have any serious side||
6141|067|S|effects, including: signs of hearing damage (such as||
6141|068|S|ringing/roaring sounds in the ears, hearing loss, dizziness),||
6141|069|S|signs of kidney problems (such as change in the amount of urine),||
6141|070|S|chest tightness/wheezing.||
6141|071|S|   A very serious allergic reaction to this drug is rare.||
6141|072|S|However, get medical help right away if you notice any symptoms||
6141|073|S|of a serious allergic reaction, including: rash, itching/swelling||
6141|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6141|075|S|breathing.||
6141|076|S|   This is not a complete list of possible side effects. If you||
6141|077|S|notice other effects not listed above, contact your doctor or||
6141|078|S|pharmacist.||
6141|079|S|   In the US -||
6141|080|S|   Call your doctor for medical advice about side effects. You||
6141|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6141|082|S|www.fda.gov/medwatch.||
6141|083|S|   In Canada - Call your doctor for medical advice about side||
6141|084|S|effects. You may report side effects to Health Canada at||
6141|085|S|1-866-234-2345.||
6141|086|B|||
6141|087|P|PRECAUTIONS:  Before using tobramycin inhalation solution, tell||
6141|088|P|your doctor or pharmacist if you are allergic to it; or to other||
6141|089|P|aminoglycoside antibiotics (such as gentamicin); or if you have||
6141|090|P|any other allergies. This product may contain inactive||
6141|091|P|ingredients, which can cause allergic reactions or other||
6141|092|P|problems. Talk to your pharmacist for more details.||
6141|093|P|   Before using this medication, tell your doctor or pharmacist||
6141|094|P|your medical history, especially of: hearing problems (including||
6141|095|P|deafness, decreased hearing), kidney problems, myasthenia gravis,||
6141|096|P|Parkinson's disease.||
6141|097|P|   Tobramycin may cause live bacterial vaccines (such as typhoid||
6141|098|P|vaccine) to not work well. Tell your health care professional||
6141|099|P|that you are using tobramycin before having any||
6141|100|P|immunizations/vaccinations.||
6141|101|P|   Before having surgery, tell your doctor or dentist about all||
6141|102|P|the products you use (including prescription drugs,||
6141|103|P|nonprescription drugs, and herbal products).||
6141|104|P|   During pregnancy, this medication should be used only when||
6141|105|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
6141|106|P|benefits with your doctor.||
6141|107|P|   It is unknown if inhaled tobramycin passes into breast milk.||
6141|108|P|Consult your doctor before breastfeeding.||
6141|109|B|||
6141|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6141|111|I|medications work or increase your risk for serious side effects.||
6141|112|I|This document does not contain all possible drug interactions.||
6141|113|I|Keep a list of all the products you use (including||
6141|114|I|prescription/nonprescription drugs and herbal products) and share||
6141|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
6141|116|I|the dosage of any medicines without your doctor's approval.||
6141|117|I|   Other medications that may affect hearing may increase the||
6141|118|I|risk of hearing loss if taken with tobramycin. Some affected||
6141|119|I|drugs include: amikacin, gentamicin, mannitol, among others.||
6141|120|B|||
6141|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6141|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6141|123|O|poison control center right away. US residents can call||
6141|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6141|125|B|||
6141|126|N|NOTES:  Do not share this medication with others.||
6141|127|N|   Lab and/or medical tests (such as breathing tests, hearing||
6141|128|N|tests, kidney function, tobramycin levels) may be done while you||
6141|129|N|are using this medication. Keep all medical and lab appointments.||
6141|130|N|Consult your doctor for more details.||
6141|131|B|||
6141|132|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6141|133|D|If it is near the time of the next dose, skip the missed dose.||
6141|134|D|Use your next dose at the regular time. Do not double the dose to||
6141|135|D|catch up.||
6141|136|B|||
6141|137|R|STORAGE:  Store ampules in the refrigerator away from light. The||
6141|138|R|ampules may also be stored at room temperature if needed. If the||
6141|139|R|ampules are stored at room temperature, discard after 28 days.||
6141|140|R|Keep all medications away from children and pets.||
6141|141|R|   Do not flush medications down the toilet or pour them into a||
6141|142|R|drain unless instructed to do so. Properly discard this product||
6141|143|R|when it is expired, or no longer needed, or if it has been stored||
6141|144|R|at room temperature for more than 28 days. Consult your||
6141|145|R|pharmacist or local waste disposal company.||
6141|146|B|||
6141|147|A|Information last revised October 2024.||
6141|148|A|Copyright(c) 2025 First Databank, Inc.||
6141|149|B|||
6143|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6143|002|Z|does NOT have all possible information about this product. This||
6143|003|Z|information does not assure that this product is safe, effective,||
6143|004|Z|or appropriate for you. This information is not individual||
6143|005|Z|medical advice and does not substitute for the advice of your||
6143|006|Z|health care professional. Always ask your health care||
6143|007|Z|professional for complete information about this product and your||
6143|008|Z|specific health needs.||
6143|009|B|||
6143|010|T|RABEPRAZOLE DELAYED-RELEASE - ORAL||
6143|011|F|(ra-BEP-ra-zole)||
6143|012|B|||
6143|013|C|COMMON BRAND NAME(S): Aciphex||
6143|014|B|||
6143|015|U|USES:  Rabeprazole is used to treat certain stomach and esophagus||
6143|016|U|problems (such as acid reflux, ulcers). It works by decreasing||
6143|017|U|the amount of acid your stomach makes. It relieves symptoms such||
6143|018|U|as heartburn, difficulty swallowing, and cough. This medication||
6143|019|U|helps heal acid damage to the stomach and esophagus, helps||
6143|020|U|prevent ulcers, and may help prevent cancer of the esophagus.||
6143|021|U|Rabeprazole belongs to a class of drugs known as proton pump||
6143|022|U|inhibitors (PPIs).||
6143|023|B|||
6143|024|H|HOW TO USE:  Read the Medication Guide and the Patient||
6143|025|H|Information Leaflet if available from your pharmacist before you||
6143|026|H|start taking rabeprazole and each time you get a refill. If you||
6143|027|H|have any questions, ask your doctor or pharmacist.||
6143|028|H|   If you are using the tablets, take your dose by mouth with or||
6143|029|H|without food as directed by your doctor, usually 1 to 2 times||
6143|030|H|daily. Swallow the tablet whole with water. Do not crush, chew,||
6143|031|H|or split the tablet. Doing so can release all of the drug at||
6143|032|H|once, increasing the risk of side effects.||
6143|033|H|   If you are using the capsules, take the dose 30 minutes before||
6143|034|H|a meal as directed by your doctor, usually once daily. Do not||
6143|035|H|swallow the capsule whole. Open the capsule and sprinkle the||
6143|036|H|contents onto a small amount of soft food (such as applesauce or||
6143|037|H|yogurt) or liquid. The food or liquid that you use should be at||
6143|038|H|or below room temperature. Swallow the entire mixture within 15||
6143|039|H|minutes of preparing it. Do not chew or crush the prepared||
6143|040|H|mixture.||
6143|041|H|   The dosage and length of treatment are based on your medical||
6143|042|H|condition and response to treatment. Children's dosage is also||
6143|043|H|based on weight.||
6143|044|H|   If needed, antacids may be taken along with this medication.||
6143|045|H|If you are also taking sucralfate, take rabeprazole at least 30||
6143|046|H|minutes before sucralfate.||
6143|047|H|   Use this medication regularly to get the most benefit from it.||
6143|048|H|To help you remember, take it at the same time(s) each day.||
6143|049|H|Continue to take this medication for the prescribed length of||
6143|050|H|treatment even if you are feeling better.||
6143|051|H|   Tell your doctor if your condition lasts or gets worse. The||
6143|052|H|risk of side effects goes up over time. Ask your doctor how long||
6143|053|H|you should take this medication.||
6143|054|B|||
6143|055|S|SIDE EFFECTS:  Headache may occur. If this effect lasts or gets||
6143|056|S|worse, tell your doctor or pharmacist promptly.||
6143|057|S|   Remember that this medication has been prescribed because your||
6143|058|S|doctor has judged that the benefit to you is greater than the||
6143|059|S|risk of side effects. Many people using this medication do not||
6143|060|S|have serious side effects.||
6143|061|S|   Tell your doctor right away if you have any serious side||
6143|062|S|effects, including: symptoms of a low magnesium blood level (such||
6143|063|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
6143|064|S|(such as rash on nose and cheeks, new or worsening joint pain),||
6143|065|S|signs of kidney problems (such as change in the amount of urine,||
6143|066|S|pink/bloody urine).||
6143|067|S|   This medication may rarely cause a severe intestinal condition||
6143|068|S|due to a bacteria called C. difficile. This condition may occur||
6143|069|S|during treatment or weeks to months after treatment has stopped.||
6143|070|S|Tell your doctor right away if you develop: diarrhea that doesn't||
6143|071|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
6143|072|S|stool.||
6143|073|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
6143|074|S|products because they may make symptoms worse.||
6143|075|S|   Rarely, proton pump inhibitors (such as rabeprazole) have||
6143|076|S|caused vitamin B-12 deficiency. The risk is increased if they are||
6143|077|S|taken every day for a long time (3 years or longer). Tell your||
6143|078|S|doctor right away if you develop symptoms of vitamin B-12||
6143|079|S|deficiency (such as unusual weakness, sore tongue, or||
6143|080|S|numbness/tingling of the hands/feet).||
6143|081|S|   A very serious allergic reaction to this drug is rare.||
6143|082|S|However, get medical help right away if you notice any symptoms||
6143|083|S|of a serious allergic reaction, including: fever, swollen lymph||
6143|084|S|nodes, rash, itching/swelling (especially of the||
6143|085|S|face/tongue/throat), severe dizziness, trouble breathing.||
6143|086|S|   This is not a complete list of possible side effects. If you||
6143|087|S|notice other effects, contact your doctor or pharmacist.||
6143|088|S|   In the US -||
6143|089|S|   Call your doctor for medical advice about side effects. You||
6143|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6143|091|S|www.fda.gov/medwatch.||
6143|092|S|   In Canada - Call your doctor for medical advice about side||
6143|093|S|effects. You may report side effects to Health Canada at||
6143|094|S|1-866-234-2345.||
6143|095|B|||
6143|096|P|PRECAUTIONS:  Before taking rabeprazole, tell your doctor or||
6143|097|P|pharmacist if you are allergic to it; or to similar drugs (such||
6143|098|P|as lansoprazole, omeprazole); or if you have any other allergies.||
6143|099|P|This product may contain inactive ingredients, which can cause||
6143|100|P|allergic reactions or other problems. Talk to your pharmacist for||
6143|101|P|more details.||
6143|102|P|   Before using this medication, tell your doctor or pharmacist||
6143|103|P|your medical history, especially of: liver disease, lupus.||
6143|104|P|   Some symptoms may actually be signs of a more serious||
6143|105|P|condition. Get medical help right away if you have: heartburn||
6143|106|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
6143|107|P|pain (especially with shortness of breath, unusual sweating),||
6143|108|P|unexplained weight loss.||
6143|109|P|   Before having surgery, tell your doctor or dentist about all||
6143|110|P|the products you use (including prescription drugs,||
6143|111|P|nonprescription drugs, and herbal products).||
6143|112|P|   Proton pump inhibitors (such as rabeprazole) may increase your||
6143|113|P|risk for bone fractures, especially with longer use, higher||
6143|114|P|doses, and in older adults. Talk with your doctor or pharmacist||
6143|115|P|about ways to prevent bone loss/fracture, such as by taking||
6143|116|P|calcium (such as calcium citrate) and vitamin D supplements.||
6143|117|P|   Older adults may be more sensitive to the side effects of this||
6143|118|P|drug, especially bone loss and fractures (see above), and C.||
6143|119|P|difficile infection (see Side Effects section).||
6143|120|P|   During pregnancy, this medication should be used only when||
6143|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
6143|122|P|   It is unknown if this medication passes into breast milk.||
6143|123|P|However, similar drugs pass into breast milk. The effects on a||
6143|124|P|nursing infant are unknown. Consult your doctor before||
6143|125|P|breastfeeding.||
6143|126|B|||
6143|127|I|DRUG INTERACTIONS:  See also How to Use section.||
6143|128|I|   Drug interactions may change how your medications work or||
6143|129|I|increase your risk for serious side effects. This document does||
6143|130|I|not contain all possible drug interactions. Keep a list of all||
6143|131|I|the products you use (including prescription/nonprescription||
6143|132|I|drugs and herbal products) and share it with your doctor and||
6143|133|I|pharmacist. Do not start, stop, or change the dosage of any||
6143|134|I|medicines without your doctor's approval.||
6143|135|I|   A product that may interact with this drug is: methotrexate||
6143|136|I|(especially high-dose treatment).||
6143|137|I|   Some products need stomach acid so that the body can absorb||
6143|138|I|them properly. Rabeprazole decreases stomach acid, so it may||
6143|139|I|change how well these products work. Some affected products||
6143|140|I|include ampicillin, atazanavir, erlotinib, levoketoconazole,||
6143|141|I|nelfinavir, pazopanib, rilpivirine, sparsentan, certain azole||
6143|142|I|antifungals (itraconazole, ketoconazole, posaconazole), among||
6143|143|I|others.||
6143|144|I|   This medication may interfere with certain lab tests, possibly||
6143|145|I|causing false test results. Make sure lab personnel and all your||
6143|146|I|doctors know you use this drug.||
6143|147|B|||
6143|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6143|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6143|150|O|poison control center right away. US residents can call||
6143|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6143|152|B|||
6143|153|N|NOTES:  Do not share this medication with others.||
6143|154|N|   If your doctor instructs you to use this medication regularly||
6143|155|N|for a long time, lab and/or medical tests (such as a magnesium||
6143|156|N|blood test, vitamin B-12 levels) may be done while you are taking||
6143|157|N|this medication. Keep all medical and lab appointments. Consult||
6143|158|N|your doctor for more details.||
6143|159|B|||
6143|160|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6143|161|D|remember. If it is near the time of the next dose, skip the||
6143|162|D|missed dose. Take your next dose at the regular time. Do not||
6143|163|D|double the dose to catch up.||
6143|164|B|||
6143|165|R|STORAGE:  Store at room temperature away from light and moisture.||
6143|166|R|Do not store in the bathroom. Keep all medications away from||
6143|167|R|children and pets.||
6143|168|R|   Do not flush medications down the toilet or pour them into a||
6143|169|R|drain unless instructed to do so. Properly discard this product||
6143|170|R|when it is expired or no longer needed. Consult your pharmacist||
6143|171|R|or local waste disposal company.||
6143|172|B|||
6143|173|A|Information last revised August 2024.||
6143|174|A|Copyright(c) 2025 First Databank, Inc.||
6143|175|B|||
6146|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6146|002|Z|does NOT have all possible information about this product. This||
6146|003|Z|information does not assure that this product is safe, effective,||
6146|004|Z|or appropriate for you. This information is not individual||
6146|005|Z|medical advice and does not substitute for the advice of your||
6146|006|Z|health care professional. Always ask your health care||
6146|007|Z|professional for complete information about this product and your||
6146|008|Z|specific health needs.||
6146|009|B|||
6146|010|T|MESALAMINE (5-AMINOSALICYLIC ACID) EXTENDED-RELEASE - ORAL||
6146|011|F|(me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id)||
6146|012|B|||
6146|013|C|COMMON BRAND NAME(S): Pentasa||
6146|014|B|||
6146|015|U|USES:  This medication is used to treat a certain bowel disease||
6146|016|U|(ulcerative colitis). It helps to reduce symptoms of ulcerative||
6146|017|U|colitis such as diarrhea, rectal bleeding, and stomach pain.||
6146|018|U|Mesalamine belongs to a class of drugs known as aminosalicylates.||
6146|019|U|It works by decreasing swelling in the colon.||
6146|020|B|||
6146|021|V|OTHER USES:  This section contains uses of this drug that are not||
6146|022|V|listed in the approved professional labeling for the drug but||
6146|023|V|that may be prescribed by your health care professional. Use this||
6146|024|V|drug for a condition that is listed in this section only if it||
6146|025|V|has been so prescribed by your health care professional.||
6146|026|V|   This drug may also be used for Crohn's disease.||
6146|027|B|||
6146|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
6146|029|H|doctor, usually 4 times daily. If you are taking the capsule form||
6146|030|H|of this medication, you may take it with or without food. If you||
6146|031|H|are taking the tablet form of this medication, take it with||
6146|032|H|meals.||
6146|033|H|   Swallow this medication whole. Do not crush, chew, or break.||
6146|034|H|Doing so can keep the drug from being released properly into the||
6146|035|H|colon. If you have trouble swallowing the capsule, you may open||
6146|036|H|the capsule and sprinkle its contents on applesauce or yogurt||
6146|037|H|before you take it. Swallow all of the drug/food mixture right||
6146|038|H|away without chewing. Do not chew the mixture or prepare a supply||
6146|039|H|in advance.||
6146|040|H|   Drink plenty of fluids during treatment with this medication||
6146|041|H|unless otherwise directed by your doctor. This will help prevent||
6146|042|H|kidney stones.||
6146|043|H|   The dosage is based on your medical condition and response to||
6146|044|H|treatment.||
6146|045|H|   Use this medication regularly in order to get the most benefit||
6146|046|H|from it. To help you remember, take it at the same times each||
6146|047|H|day.||
6146|048|H|   Tell your doctor if your condition does not get better or if||
6146|049|H|it gets worse.||
6146|050|B|||
6146|051|S|SIDE EFFECTS:  Diarrhea, headache, nausea, or vomiting may occur.||
6146|052|S|If any of these effects last or get worse, tell your doctor or||
6146|053|S|pharmacist promptly.||
6146|054|S|   Remember that this medication has been prescribed because your||
6146|055|S|doctor has judged that the benefit to you is greater than the||
6146|056|S|risk of side effects. Many people using this medication do not||
6146|057|S|have serious side effects.||
6146|058|S|   Rarely, mesalamine can worsen ulcerative colitis. Tell your||
6146|059|S|doctor right away if your symptoms worsen after starting this||
6146|060|S|medication (such as increased abdominal pain/cramping, bloody||
6146|061|S|diarrhea).||
6146|062|S|   Tell your doctor right away if you have any serious side||
6146|063|S|effects, including: nausea/vomiting that doesn't stop, signs of||
6146|064|S|kidney problems (such as change in the amount of urine, blood in||
6146|065|S|the urine), dark urine, severe stomach/abdominal pain, yellowing||
6146|066|S|eyes/skin, chest pain, shortness of breath.||
6146|067|S|   A very serious allergic reaction to this drug is rare.||
6146|068|S|However, get medical help right away if you notice any symptoms||
6146|069|S|of a serious allergic reaction, including: fever, swollen lymph||
6146|070|S|nodes, rash, itching/swelling (especially of the||
6146|071|S|face/tongue/throat), severe dizziness, trouble breathing.||
6146|072|S|   This is not a complete list of possible side effects. If you||
6146|073|S|notice other effects not listed above, contact your doctor or||
6146|074|S|pharmacist.||
6146|075|S|   In the US -||
6146|076|S|   Call your doctor for medical advice about side effects. You||
6146|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6146|078|S|www.fda.gov/medwatch.||
6146|079|S|   In Canada - Call your doctor for medical advice about side||
6146|080|S|effects. You may report side effects to Health Canada at||
6146|081|S|1-866-234-2345.||
6146|082|B|||
6146|083|P|PRECAUTIONS:  Before taking mesalamine, tell your doctor or||
6146|084|P|pharmacist if you are allergic to it; or to other||
6146|085|P|aminosalicylates (such as balsalazide, olsalazine); or to||
6146|086|P|salicylates (such as aspirin, salsalate); or to sulfasalazine; or||
6146|087|P|if you have any other allergies. This product may contain||
6146|088|P|inactive ingredients, which can cause allergic reactions or other||
6146|089|P|problems. Talk to your pharmacist for more details.||
6146|090|P|   Before using this medication, tell your doctor or pharmacist||
6146|091|P|your medical history, especially of: kidney disease, liver||
6146|092|P|disease, stomach blockage (such as pyloric stenosis).||
6146|093|P|   This medication may make you more sensitive to the sun,||
6146|094|P|especially if you have skin problems (such as atopic dermatitis,||
6146|095|P|eczema). Limit your time in the sun. Avoid tanning booths and||
6146|096|P|sunlamps. Use sunscreen and wear protective clothing when||
6146|097|P|outdoors. Tell your doctor right away if you get sunburned or||
6146|098|P|have skin blisters/redness.||
6146|099|P|   Before having surgery, tell your doctor or dentist about all||
6146|100|P|the products you use (including prescription drugs,||
6146|101|P|nonprescription drugs, and herbal products).||
6146|102|P|   This medication is similar to aspirin. Children and teenagers||
6146|103|P|younger than 18 years should not take aspirin or aspirin-related||
6146|104|P|medications (such as salicylates) if they have chickenpox, flu,||
6146|105|P|or any undiagnosed illness, or if they have recently received a||
6146|106|P|vaccine. In these cases, taking aspirin increases the risk of||
6146|107|P|Reye's syndrome, a rare but serious illness.||
6146|108|P|   During pregnancy, this medication should be used only when||
6146|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
6146|110|P|   This medication passes into breast milk and may have||
6146|111|P|undesirable effects on a nursing infant. Consult your doctor||
6146|112|P|before breastfeeding.||
6146|113|B|||
6146|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6146|115|I|medications work or increase your risk for serious side effects.||
6146|116|I|This document does not contain all possible drug interactions.||
6146|117|I|Keep a list of all the products you use (including||
6146|118|I|prescription/nonprescription drugs and herbal products) and share||
6146|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
6146|120|I|the dosage of any medicines without your doctor's approval.||
6146|121|I|   Mesalamine is very similar to balsalazide, olsalazine, and||
6146|122|I|sulfasalazine. Do not use medications containing balsalazide,||
6146|123|I|olsalazine, or sulfasalazine while using mesalamine.||
6146|124|I|   This medication may interfere with certain lab tests (such as||
6146|125|I|urine normetanephrine levels), possibly causing false test||
6146|126|I|results. Make sure lab personnel and all your doctors know you||
6146|127|I|use this drug.||
6146|128|B|||
6146|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6146|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6146|131|O|poison control center right away. US residents can call||
6146|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6146|133|O|Symptoms of overdose may include: ringing in the ears, confusion,||
6146|134|O|rapid breathing, seizures.||
6146|135|B|||
6146|136|N|NOTES:  Do not share this medication with others.||
6146|137|N|   Lab and/or medical tests (such as liver/kidney function) may||
6146|138|N|be done before you start taking this medication and while you are||
6146|139|N|taking it. Keep all medical and lab appointments. Consult your||
6146|140|N|doctor for more details.||
6146|141|B|||
6146|142|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6146|143|D|remember. If it is near the time of the next dose, skip the||
6146|144|D|missed dose. Take your next dose at the regular time. Do not||
6146|145|D|double the dose to catch up.||
6146|146|B|||
6146|147|R|STORAGE:  Store at room temperature away from light and moisture.||
6146|148|R|Do not store in the bathroom. Keep all medications away from||
6146|149|R|children and pets.||
6146|150|R|   Do not flush medications down the toilet or pour them into a||
6146|151|R|drain unless instructed to do so. Properly discard this product||
6146|152|R|when it is expired or no longer needed. Consult your pharmacist||
6146|153|R|or local waste disposal company.||
6146|154|B|||
6146|155|A|Information last revised October 2024.||
6146|156|A|Copyright(c) 2025 First Databank, Inc.||
6146|157|B|||
6152|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6152|002|Z|does NOT have all possible information about this product. This||
6152|003|Z|information does not assure that this product is safe, effective,||
6152|004|Z|or appropriate for you. This information is not individual||
6152|005|Z|medical advice and does not substitute for the advice of your||
6152|006|Z|health care professional. Always ask your health care||
6152|007|Z|professional for complete information about this product and your||
6152|008|Z|specific health needs.||
6152|009|B|||
6152|010|T|OXYBUTYNIN - TRANSDERMAL||
6152|011|F|(OX-i-BUE-ti-nin)||
6152|012|B|||
6152|013|C|COMMON BRAND NAME(S): Oxytrol||
6152|014|B|||
6152|015|U|USES:  Oxybutynin is used to treat an overactive bladder. By||
6152|016|U|relaxing the muscles in the bladder, oxybutynin improves symptoms||
6152|017|U|such as the inability to control urination (incontinence),||
6152|018|U|feeling that one has to urinate (urgency), and having to go to||
6152|019|U|the bathroom often (frequency). This medication belongs to the||
6152|020|U|class of drugs known as antispasmodics.||
6152|021|U|   This medication is not recommended for use in children younger||
6152|022|U|than 5 years of age. Consult your doctor for more information.||
6152|023|U|   Unless otherwise directed by your doctor, the over-the-counter||
6152|024|U|product should only be used by adult women who have symptoms of||
6152|025|U|overactive bladder for at least 2 months.||
6152|026|U|   For over-the-counter products, carefully read the package||
6152|027|U|instructions to make sure the product is right for you. Check the||
6152|028|U|ingredients on the label even if you have used the product||
6152|029|U|before. The manufacturer may have changed the ingredients. Also,||
6152|030|U|products with similar names may contain different ingredients||
6152|031|U|meant for different purposes. Taking the wrong product could harm||
6152|032|U|you.||
6152|033|B|||
6152|034|H|HOW TO USE:  If you are taking the over-the-counter product to||
6152|035|H|self treat, read all directions on the product package before||
6152|036|H|taking this medication. If your doctor has prescribed this||
6152|037|H|medication, read the Patient Information Leaflet if available||
6152|038|H|from your pharmacist before you start using oxybutynin and each||
6152|039|H|time you get a refill. If you have any questions, consult your||
6152|040|H|doctor or pharmacist.||
6152|041|H|   Apply one patch to your skin as directed by your doctor,||
6152|042|H|usually every 3 to 4 days. If you are self-treating, apply one||
6152|043|H|patch to your skin every 4 days. Follow the dosing schedule||
6152|044|H|carefully.||
6152|045|H|   Before applying the patch, wash the area you will be using for||
6152|046|H|the patch gently and thoroughly with soap and water. Rinse and||
6152|047|H|dry with a clean dry towel.||
6152|048|H|   Apply the new patch to a different area of skin to prevent||
6152|049|H|skin irritation. Do not apply a patch to the same area within 7||
6152|050|H|days. Remember to remove the old patch before applying a new||
6152|051|H|patch. If the area around the patch becomes red, itchy, or||
6152|052|H|irritated, try a new site. If irritation continues or becomes||
6152|053|H|worse, tell your doctor promptly.||
6152|054|H|   Do not open the sealed pouch container until you are ready to||
6152|055|H|apply the patch. Open the pouch and remove the protective liner||
6152|056|H|from the patch to expose the adhesive. Apply the patch to an area||
6152|057|H|of clean, dry, smooth skin on the stomach (abdomen), hips, or||
6152|058|H|buttocks. Press firmly to be sure the patch stays on. Apply to an||
6152|059|H|area of skin that is under clothing and protected from sunlight.||
6152|060|H|Avoid applying the patch on your waistline, since tight clothing||
6152|061|H|may rub the patch off, or on areas where sitting may loosen it.||
6152|062|H|Do not apply the patch to oily/red/cut/irritated/broken skin or||
6152|063|H|skin covered with lotion or powder. Do not cut the patch into||
6152|064|H|smaller sizes or use the patch if it is broken, cut, or damaged.||
6152|065|H|   Contact with water (such as swimming, bathing) will not change||
6152|066|H|the way the patch works. Avoid rubbing the patch area during||
6152|067|H|these activities.||
6152|068|H|   If the patch falls off, reapply it or apply a new patch to a||
6152|069|H|new area and continue on your same schedule.||
6152|070|H|   When it is time to apply a new patch, remove the old one and||
6152|071|H|dispose of it properly in the trash. Fold the sticky sides of the||
6152|072|H|patch together and throw it away where it cannot be accidentally||
6152|073|H|worn or swallowed by others, especially a child or pet.||
6152|074|H|   The length of treatment is determined by your doctor, who may||
6152|075|H|have you stop using the medication sometimes to see if you still||
6152|076|H|need to use it.||
6152|077|H|   Use this medication regularly to get the most benefit from it.||
6152|078|H|To help you remember, try to always change the patch on the same||
6152|079|H|2 days of the week. Do not increase your dose or use this drug||
6152|080|H|more often or for longer than prescribed. Your condition will not||
6152|081|H|improve any faster, and your risk of side effects will increase.||
6152|082|H|   Tell your doctor if your condition lasts or gets worse. If you||
6152|083|H|are self-treating, tell your doctor if your condition does not||
6152|084|H|get better after 2 weeks. If you think you may have a serious||
6152|085|H|medical problem, get medical help right away.||
6152|086|B|||
6152|087|S|SIDE EFFECTS:  Skin redness/itching/irritation at the application||
6152|088|S|site, dry mouth, drowsiness, dizziness, blurred vision, headache,||
6152|089|S|weakness, nausea or constipation may occur. If any of these||
6152|090|S|effects last or get worse, tell your doctor or pharmacist||
6152|091|S|promptly.||
6152|092|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
6152|093|S|chips, chew (sugarless) gum, drink water or use a saliva||
6152|094|S|substitute.||
6152|095|S|   To prevent constipation, eat dietary fiber, drink enough||
6152|096|S|water, and exercise. You may also need to take a laxative. Ask||
6152|097|S|your pharmacist which type of laxative is right for you.||
6152|098|S|   If your doctor has directed you to use this medication,||
6152|099|S|remember that your doctor has judged that the benefit to you is||
6152|100|S|greater than the risk of side effects. Many people using this||
6152|101|S|medication do not have serious side effects.||
6152|102|S|   Tell your doctor right away if you have any serious side||
6152|103|S|effects, including: vision problems (including eye pain),||
6152|104|S|difficulty urinating, signs of kidney infection (such as||
6152|105|S|burning/painful/frequent urination, lower back pain),||
6152|106|S|fast/irregular heartbeat, mental/mood changes (such as confusion,||
6152|107|S|hallucinations), fever, flushed/hot/dry skin, signs of||
6152|108|S|stomach/intestinal blockage (such as nausea/vomiting that doesn't||
6152|109|S|stop, severe stomach pain, severe constipation).||
6152|110|S|   A very serious allergic reaction to this drug is rare.||
6152|111|S|However, get medical help right away if you notice any symptoms||
6152|112|S|of a serious allergic reaction, including: rash, itching/swelling||
6152|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6152|114|S|breathing.||
6152|115|S|   This is not a complete list of possible side effects. If you||
6152|116|S|notice other effects not listed above, contact your doctor or||
6152|117|S|pharmacist.||
6152|118|S|   In the US -||
6152|119|S|   Call your doctor for medical advice about side effects. You||
6152|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6152|121|S|www.fda.gov/medwatch.||
6152|122|S|   In Canada - Call your doctor for medical advice about side||
6152|123|S|effects. You may report side effects to Health Canada at||
6152|124|S|1-866-234-2345.||
6152|125|B|||
6152|126|P|PRECAUTIONS:  Before using oxybutynin, tell your doctor or||
6152|127|P|pharmacist if you are allergic to it; or if you have any other||
6152|128|P|allergies. This product may contain inactive ingredients, which||
6152|129|P|can cause allergic reactions or other problems. Talk to your||
6152|130|P|pharmacist for more details.||
6152|131|P|   Before using this medication, tell your doctor or pharmacist||
6152|132|P|your medical history, especially of: active internal bleeding,||
6152|133|P|blockage/slowed movement of the stomach/intestines (such as||
6152|134|P|gastric retention, paralytic ileus), certain bladder problems||
6152|135|P|(urinary retention, bladder outflow obstruction, stress||
6152|136|P|incontinence), glaucoma (narrow-angle), a certain muscle disease||
6152|137|P|(myasthenia gravis), liver disease, high blood pressure, heart||
6152|138|P|problems (such as coronary artery disease, heart failure,||
6152|139|P|arrhythmias), stomach/intestinal disease (such as acid reflux,||
6152|140|P|hiatal hernia, ulcerative colitis, intestinal atony), kidney||
6152|141|P|disease, loss of mental abilities (dementia), enlarged prostate,||
6152|142|P|overactive thyroid (hyperthyroidism), a certain nervous system||
6152|143|P|disorder (autonomic neuropathy), Parkinson's disease.||
6152|144|P|   In addition, before you self treat with this medication, tell||
6152|145|P|your doctor if you have any of these signs of a more serious||
6152|146|P|condition: signs of a bladder/kidney infection (such as||
6152|147|P|burning/pain when you urinate, fever, pink/bloody urine), signs||
6152|148|P|of diabetes (such as increased thirst, dizziness/fainting, vision||
6152|149|P|changes, increased urination, wounds that are slow to heal).||
6152|150|P|   This drug may make you dizzy or drowsy or blur your vision.||
6152|151|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
6152|152|P|drowsy. Do not drive, use machinery, or do anything that needs||
6152|153|P|alertness or clear vision until you can do it safely. Limit||
6152|154|P|alcoholic beverages. Talk to your doctor if you are using||
6152|155|P|marijuana (cannabis).||
6152|156|P|   Before having surgery, tell your doctor or dentist about all||
6152|157|P|the products you use (including prescription drugs,||
6152|158|P|nonprescription drugs, and herbal products).||
6152|159|P|   This medication may make you sweat less, making you more||
6152|160|P|likely to get heat stroke. Avoid doing things that may cause you||
6152|161|P|to overheat, such as hard work or exercise in hot weather, or||
6152|162|P|using hot tubs. When the weather is hot, drink a lot of fluids||
6152|163|P|and dress lightly. If you overheat, quickly look for a place to||
6152|164|P|cool down and rest. Get medical help right away if you have a||
6152|165|P|fever that does not go away, mental/mood changes, headache, or||
6152|166|P|dizziness.||
6152|167|P|   If you are going to have an MRI test, tell testing personnel||
6152|168|P|that you are using this patch. Some patches may contain metals||
6152|169|P|that can cause serious burns during an MRI. Ask your doctor||
6152|170|P|whether you will need to remove your patch before the test and||
6152|171|P|apply a new patch afterward, and how to do so properly.||
6152|172|P|   Older adults may be more sensitive to the side effects of this||
6152|173|P|drug, especially drowsiness, confusion, constipation, trouble||
6152|174|P|urinating. Drowsiness and confusion can increase the risk of||
6152|175|P|falling.||
6152|176|P|   During pregnancy, this medication should be used only when||
6152|177|P|clearly needed. Discuss the risks and benefits with your doctor.||
6152|178|P|   It is unknown if this medication passes into breast milk.||
6152|179|P|Consult your doctor before breastfeeding.||
6152|180|B|||
6152|181|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6152|182|I|medications work or increase your risk for serious side effects.||
6152|183|I|This document does not contain all possible drug interactions.||
6152|184|I|Keep a list of all the products you use (including||
6152|185|I|prescription/nonprescription drugs and herbal products) and share||
6152|186|I|it with your doctor and pharmacist. Do not start, stop, or change||
6152|187|I|the dosage of any medicines without your doctor's approval.||
6152|188|I|   Some products that may interact with this drug include:||
6152|189|I|pramlintide, drugs that can irritate the esophagus/stomach (such||
6152|190|I|as potassium tablets/capsules, oral bisphosphonates including||
6152|191|I|alendronate).||
6152|192|I|   Tell your doctor or pharmacist if you are using other products||
6152|193|I|that cause drowsiness such as opioid pain or cough relievers||
6152|194|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
6152|195|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
6152|196|I|zolpidem), muscle relaxants (such as carisoprodol,||
6152|197|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6152|198|I|diphenhydramine).||
6152|199|I|   Check the labels on all your medicines (such as allergy or||
6152|200|I|cough-and-cold products) because they may contain ingredients||
6152|201|I|that can cause drowsiness, constipation or blurred vision. Ask||
6152|202|I|your pharmacist about using those products safely.||
6152|203|B|||
6152|204|O|OVERDOSE:  This medication patch may be harmful if chewed or||
6152|205|O|swallowed. If someone has overdosed, remove the patch if||
6152|206|O|possible. For serious symptoms such as passing out or trouble||
6152|207|O|breathing, call 911. Otherwise, call a poison control center||
6152|208|O|right away. US residents can call 1-800-222-1222. Canada||
6152|209|O|residents can call 1-844-764-7669. Symptoms of overdose may||
6152|210|O|include: unusual excitement, agitation, fast/irregular heartbeat.||
6152|211|B|||
6152|212|N|NOTES:  If your doctor has prescribed this medication for you, do||
6152|213|N|not share it with others.||
6152|214|N|   Keep all medical and lab appointments.||
6152|215|B|||
6152|216|D|MISSED DOSE:  If you are using this product on a regular schedule||
6152|217|D|and forget to change the patch on the right day, remove the old||
6152|218|D|patch and apply a new one as soon as you remember. Continue to||
6152|219|D|follow your original schedule for changing the patch. Do not||
6152|220|D|double the dose to catch up.||
6152|221|B|||
6152|222|R|STORAGE:  Store at room temperature away from heat. Keep the||
6152|223|R|medication in the original sealed pouch to protect from light and||
6152|224|R|moisture. Different brands of this medication have different||
6152|225|R|storage needs. Check the product package for instructions on how||
6152|226|R|to store your brand, or ask your pharmacist. Keep all medications||
6152|227|R|away from children and pets.||
6152|228|R|   Do not flush medications down the toilet or pour them into a||
6152|229|R|drain unless instructed to do so. Properly discard this product||
6152|230|R|when it is expired or no longer needed (See also How to Use||
6152|231|R|section). Consult your pharmacist or local waste disposal||
6152|232|R|company.||
6152|233|B|||
6152|234|A|Information last revised April 2025.||
6152|235|A|Copyright(c) 2025 First Databank, Inc.||
6152|236|B|||
6153|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6153|002|Z|does NOT have all possible information about this product. This||
6153|003|Z|information does not assure that this product is safe, effective,||
6153|004|Z|or appropriate for you. This information is not individual||
6153|005|Z|medical advice and does not substitute for the advice of your||
6153|006|Z|health care professional. Always ask your health care||
6153|007|Z|professional for complete information about this product and your||
6153|008|Z|specific health needs.||
6153|009|B|||
6153|010|T|ATOVAQUONE SUSPENSION - ORAL||
6153|011|F|(a-TOE-va-kwone)||
6153|012|B|||
6153|013|C|COMMON BRAND NAME(S): Mepron||
6153|014|B|||
6153|015|U|USES:  Atovaquone is used to prevent or treat a serious lung||
6153|016|U|infection called Pneumocystis pneumonia (PCP). This medication||
6153|017|U|helps to stop infection symptoms such as fever, cough, tiredness,||
6153|018|U|and shortness of breath.||
6153|019|B|||
6153|020|H|HOW TO USE:  Shake the bottle gently but well before each dose.||
6153|021|H|Carefully measure the dose using a special measuring||
6153|022|H|device/spoon. Do not use a household spoon because you may not||
6153|023|H|get the correct dose.||
6153|024|H|   To treat PCP, take this medication by mouth with food as||
6153|025|H|directed by your doctor, usually twice daily for 21 days. To||
6153|026|H|prevent PCP, take this medication with food usually once a day as||
6153|027|H|directed. Atovaquone must be taken with food so your body can||
6153|028|H|absorb as much of the medication as possible so it can work well.||
6153|029|H|   Children's dosage is also based on age and weight.||
6153|030|H|   This medication works best when the amount of medicine in your||
6153|031|H|body is kept at a constant level. If you take this drug twice a||
6153|032|H|day, take it at evenly spaced intervals about 12 hours apart. If||
6153|033|H|you take this medication once a day, take it at the same time||
6153|034|H|each day.||
6153|035|H|   Continue to take this medication for the full time prescribed,||
6153|036|H|even if symptoms disappear after a few days. Stopping the||
6153|037|H|medication too early may result in a return of the infection.||
6153|038|H|   Tell your doctor if you develop symptoms of PCP, or if your||
6153|039|H|condition lasts or gets worse.||
6153|040|B|||
6153|041|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, dizziness,||
6153|042|S|trouble sleeping, or runny nose may occur. If any of these||
6153|043|S|effects last or get worse, tell your doctor or pharmacist||
6153|044|S|promptly.||
6153|045|S|   Remember that this medication has been prescribed because your||
6153|046|S|doctor has judged that the benefit to you is greater than the||
6153|047|S|risk of side effects. Many people using this medication do not||
6153|048|S|have serious side effects.||
6153|049|S|   Tell your doctor right away if you have any serious side||
6153|050|S|effects, including: depression, symptoms of liver disease (such||
6153|051|S|as nausea/vomiting that doesn't stop, loss of appetite,||
6153|052|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
6153|053|S|   Atovaquone can commonly cause a mild rash that is usually not||
6153|054|S|serious. However, you may not be able to tell it apart from a||
6153|055|S|rare rash that could be a sign of a severe reaction. Get medical||
6153|056|S|help right away if you develop any rash.||
6153|057|S|   A very serious allergic reaction to this drug is rare.||
6153|058|S|However, get medical help right away if you notice any symptoms||
6153|059|S|of a serious allergic reaction, including: rash, itching/swelling||
6153|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6153|061|S|breathing.||
6153|062|S|   This is not a complete list of possible side effects. If you||
6153|063|S|notice other effects not listed above, contact your doctor or||
6153|064|S|pharmacist.||
6153|065|S|   In the US -||
6153|066|S|   Call your doctor for medical advice about side effects. You||
6153|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6153|068|S|www.fda.gov/medwatch.||
6153|069|S|   In Canada - Call your doctor for medical advice about side||
6153|070|S|effects. You may report side effects to Health Canada at||
6153|071|S|1-866-234-2345.||
6153|072|B|||
6153|073|P|PRECAUTIONS:  Before taking atovaquone, tell your doctor or||
6153|074|P|pharmacist if you are allergic to it; or if you have any other||
6153|075|P|allergies. This product may contain inactive ingredients, which||
6153|076|P|can cause allergic reactions or other problems. Talk to your||
6153|077|P|pharmacist for more details.||
6153|078|P|   Before using this medication, tell your doctor or pharmacist||
6153|079|P|your medical history, especially of: liver disease, kidney||
6153|080|P|disease, stomach/intestinal problems that may affect absorption||
6153|081|P|of atovaquone (such as long-term diarrhea, malabsorption||
6153|082|P|syndrome).||
6153|083|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6153|084|P|can make you more dizzy. Do not drive, use machinery, or do||
6153|085|P|anything that needs alertness until you can do it safely. Limit||
6153|086|P|alcoholic beverages. Talk to your doctor if you are using||
6153|087|P|marijuana (cannabis).||
6153|088|P|   Before having surgery, tell your doctor or dentist about all||
6153|089|P|the products you use (including prescription drugs,||
6153|090|P|nonprescription drugs, and herbal products).||
6153|091|P|   During pregnancy, this medication should be used only when||
6153|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
6153|093|P|   It is unknown if this drug passes into breast milk. Consult||
6153|094|P|your doctor before breastfeeding.||
6153|095|B|||
6153|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6153|097|I|medications work or increase your risk for serious side effects.||
6153|098|I|This document does not contain all possible drug interactions.||
6153|099|I|Keep a list of all the products you use (including||
6153|100|I|prescription/nonprescription drugs and herbal products) and share||
6153|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
6153|102|I|the dosage of any medicines without your doctor's approval.||
6153|103|I|   Other medications can decrease the level of atovaquone in your||
6153|104|I|body, which may affect how atovaquone works. Examples include||
6153|105|I|efavirenz, metoclopramide, rifampin, rifabutin, tetracycline,||
6153|106|I|among others.||
6153|107|B|||
6153|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6153|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6153|110|O|poison control center right away. US residents can call||
6153|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6153|112|B|||
6153|113|N|NOTES:  Do not share this medication with others.||
6153|114|N|   This medication has been prescribed for your current condition||
6153|115|N|only. Do not use it later for another infection unless your||
6153|116|N|doctor tells you to.||
6153|117|B|||
6153|118|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6153|119|D|remember. If it is near the time of the next dose, skip the||
6153|120|D|missed dose. Take your next dose at the regular time. Do not||
6153|121|D|double the dose to catch up.||
6153|122|B|||
6153|123|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
6153|124|R|medications away from children and pets.||
6153|125|R|   Do not flush medications down the toilet or pour them into a||
6153|126|R|drain unless instructed to do so. Properly discard this product||
6153|127|R|when it is expired or no longer needed. Consult your pharmacist||
6153|128|R|or local waste disposal company.||
6153|129|B|||
6153|130|A|Information last revised October 2024.||
6153|131|A|Copyright(c) 2025 First Databank, Inc.||
6153|132|B|||
6154|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6154|002|Z|does NOT have all possible information about this product. This||
6154|003|Z|information does not assure that this product is safe, effective,||
6154|004|Z|or appropriate for you. This information is not individual||
6154|005|Z|medical advice and does not substitute for the advice of your||
6154|006|Z|health care professional. Always ask your health care||
6154|007|Z|professional for complete information about this product and your||
6154|008|Z|specific health needs.||
6154|009|B|||
6154|010|T|LINEZOLID - ORAL||
6154|011|F|(lin-AYZ-oh-lid)||
6154|012|B|||
6154|013|C|COMMON BRAND NAME(S): Zyvox||
6154|014|B|||
6154|015|U|USES:  Linezolid is an antibiotic used to treat certain serious||
6154|016|U|bacterial infections. It works by stopping the growth of||
6154|017|U|bacteria.||
6154|018|U|   This antibiotic treats only bacterial infections. It will not||
6154|019|U|work for viral infections (such as common cold, flu). Using any||
6154|020|U|antibiotic when it is not needed can cause it to not work for||
6154|021|U|future infections.||
6154|022|U|   Linezolid also belongs to a class of drugs known as MAO||
6154|023|U|inhibitors. It can increase the levels of certain natural||
6154|024|U|substances in the body (such as dopamine, norepinephrine,||
6154|025|U|serotonin) which can increase the chance of certain side effects||
6154|026|U|and food and drug interactions. See How to Use, Side Effects, and||
6154|027|U|Drug Interactions sections for more details.||
6154|028|B|||
6154|029|H|HOW TO USE:  Take this medication by mouth with or without food||
6154|030|H|as directed by your doctor, usually every 12 hours. The dosage is||
6154|031|H|based on your medical condition and response to treatment.||
6154|032|H|Children's dosage is also based on age and weight, and they may||
6154|033|H|be directed to take this medication every 8 hours.||
6154|034|H|   To prevent a very serious high blood pressure reaction, it is||
6154|035|H|very important that you follow a special diet recommended by your||
6154|036|H|doctor or dietician to limit your intake of tyramine while you||
6154|037|H|are taking this medicine. Avoid foods and beverages that are high||
6154|038|H|in tyramine, including aged cheeses, dried/aged meats and||
6154|039|H|sausages (such as salami, liverwurst), preserved fish (such as||
6154|040|H|pickled herring), products that contain large amounts of yeast||
6154|041|H|(such as bouillon cubes, powdered soup/gravy, homemade or||
6154|042|H|sourdough bread), fermented foods (such as sauerkraut, kim chee),||
6154|043|H|most soybean products (such as soy sauce, tofu), broad/fava||
6154|044|H|beans, red wine, sherry, tap beers, and vermouth. Consult your||
6154|045|H|doctor or dietician for more details and a complete list of other||
6154|046|H|foods that contain tyramine which you should limit or avoid.||
6154|047|H|   For the best effect, take this antibiotic at evenly spaced||
6154|048|H|times. To help you remember, take this medication at the same||
6154|049|H|time(s) every day.||
6154|050|H|   Continue to take this medication until the full prescribed||
6154|051|H|amount is finished, even if symptoms disappear after a few days.||
6154|052|H|Stopping the medication too early may result in a return of the||
6154|053|H|infection.||
6154|054|H|   Tell your doctor if your condition lasts or gets worse.||
6154|055|B|||
6154|056|S|SIDE EFFECTS:  Diarrhea, headache, nausea, vomiting, or dizziness||
6154|057|S|may occur. If any of these effects last or get worse, tell your||
6154|058|S|doctor or pharmacist promptly.||
6154|059|S|   Remember that this medication has been prescribed because your||
6154|060|S|doctor has judged that the benefit to you is greater than the||
6154|061|S|risk of side effects. Many people using this medication do not||
6154|062|S|have serious side effects.||
6154|063|S|   Tell your doctor right away if you have any serious side||
6154|064|S|effects, including: deep/fast breathing, unusual drowsiness,||
6154|065|S|nausea/vomiting that doesn't stop, numbness/tingling of the||
6154|066|S|hands/feet, unusual tiredness, easy bruising/bleeding, muscle||
6154|067|S|pain/tenderness/weakness.||
6154|068|S|   Get medical help right away if you have any very serious side||
6154|069|S|effects, including: muscle stiffness, increased sweating, vision||
6154|070|S|changes (such as blurred vision, change in color vision, loss of||
6154|071|S|vision), mental/mood changes (such as agitation, confusion),||
6154|072|S|seizure.||
6154|073|S|   This medication may rarely cause a severe intestinal condition||
6154|074|S|due to a bacteria called C. difficile. This condition may occur||
6154|075|S|during treatment or weeks to months after treatment has stopped.||
6154|076|S|Tell your doctor right away if you develop: diarrhea that doesn't||
6154|077|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
6154|078|S|stool.||
6154|079|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
6154|080|S|products because they may make symptoms worse||
6154|081|S|   Use of this medication for prolonged or repeated periods may||
6154|082|S|result in oral thrush or a new yeast infection. Contact your||
6154|083|S|doctor if you notice white patches in your mouth, a change in||
6154|084|S|vaginal discharge, or other new symptoms.||
6154|085|S|   This medication may increase serotonin and rarely cause a very||
6154|086|S|serious condition called serotonin syndrome/toxicity. The risk||
6154|087|S|increases if you are also taking other drugs that increase||
6154|088|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
6154|089|S|take. Get medical help right away if you develop some of the||
6154|090|S|following symptoms: fast heartbeat, hallucinations, loss of||
6154|091|S|coordination, severe dizziness, unexplained fever, severe||
6154|092|S|nausea/vomiting/diarrhea, twitching muscles, unusual||
6154|093|S|agitation/restlessness.||
6154|094|S|   This drug may rarely cause an attack of extremely high blood||
6154|095|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
6154|096|S|food interactions can increase this risk (see How to Use and Drug||
6154|097|S|Interactions sections). Get medical help right away if any of||
6154|098|S|these serious side effects occur: severe headache,||
6154|099|S|fast/slow/irregular/pounding heartbeat, chest pain, neck||
6154|100|S|stiffness/soreness, severe nausea/vomiting, sweating/clammy skin||
6154|101|S|(sometimes with fever), widened pupils, vision changes (such as||
6154|102|S|double/blurred vision), sudden sensitivity to light||
6154|103|S|(photophobia).||
6154|104|S|   A very serious allergic reaction to this drug is rare.||
6154|105|S|However, get medical help right away if you notice any symptoms||
6154|106|S|of a serious allergic reaction, including: rash, itching/swelling||
6154|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6154|108|S|breathing.||
6154|109|S|   This is not a complete list of possible side effects. If you||
6154|110|S|notice other effects not listed above, contact your doctor or||
6154|111|S|pharmacist.||
6154|112|S|   In the US -||
6154|113|S|   Call your doctor for medical advice about side effects. You||
6154|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6154|115|S|www.fda.gov/medwatch.||
6154|116|S|   In Canada - Call your doctor for medical advice about side||
6154|117|S|effects. You may report side effects to Health Canada at||
6154|118|S|1-866-234-2345.||
6154|119|B|||
6154|120|P|PRECAUTIONS:  Before taking linezolid, tell your doctor or||
6154|121|P|pharmacist if you are allergic to it; or if you have any other||
6154|122|P|allergies. This product may contain inactive ingredients, which||
6154|123|P|can cause allergic reactions or other problems. Talk to your||
6154|124|P|pharmacist for more details.||
6154|125|P|   Before using this medication, tell your doctor or pharmacist||
6154|126|P|your medical history, especially of: high blood pressure,||
6154|127|P|blood/bone marrow problems (such as low red/white blood cells and||
6154|128|P|platelets), kidney problems, liver problems, certain tumor||
6154|129|P|conditions (such as pheochromocytoma, carcinoid syndrome),||
6154|130|P|overactive thyroid, seizures.||
6154|131|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6154|132|P|can make you more dizzy. Do not drive, use machinery, or do||
6154|133|P|anything that needs alertness until you can do it safely. Limit||
6154|134|P|alcoholic beverages. Talk to your doctor if you are using||
6154|135|P|marijuana (cannabis).||
6154|136|P|   If you have diabetes, linezolid may lower your blood sugar.||
6154|137|P|Check your blood sugar regularly as directed and share the||
6154|138|P|results with your doctor. Tell your doctor right away if you have||
6154|139|P|symptoms of low blood sugar such as sudden sweating, shaking,||
6154|140|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
6154|141|P|hands/feet. Your doctor may need to adjust your diabetes||
6154|142|P|medication, exercise program, or diet.||
6154|143|P|   Linezolid may cause live bacterial vaccines (such as typhoid||
6154|144|P|vaccine) to not work well. Tell your health care professional||
6154|145|P|that you are using linezolid before having any||
6154|146|P|immunizations/vaccinations.||
6154|147|P|   Before having surgery, tell your doctor or dentist about all||
6154|148|P|the products you use (including prescription drugs,||
6154|149|P|nonprescription drugs, and herbal products).||
6154|150|P|   During pregnancy, this medication should be used only when||
6154|151|P|clearly needed. Discuss the risks and benefits with your doctor.||
6154|152|P|   This medication passes into breast milk and may have||
6154|153|P|undesirable effects on a nursing infant. Consult your doctor||
6154|154|P|before breastfeeding.||
6154|155|B|||
6154|156|I|DRUG INTERACTIONS:  See also How to Use section.||
6154|157|I|   Drug interactions may change how your medications work or||
6154|158|I|increase your risk for serious side effects. This document does||
6154|159|I|not contain all possible drug interactions. Keep a list of all||
6154|160|I|the products you use (including prescription/nonprescription||
6154|161|I|drugs and herbal products) and share it with your doctor and||
6154|162|I|pharmacist. Do not start, stop, or change the dosage of any||
6154|163|I|medicines without your doctor's approval.||
6154|164|I|   Some products that may interact with this drug include: diet||
6154|165|I|pills/appetite suppressants (such as diethylpropion), drugs for||
6154|166|I|attention deficit disorder (such as atomoxetine,||
6154|167|I|methylphenidate), apraclonidine, bupropion, buspirone,||
6154|168|I|carbamazepine, cyclobenzaprine, deutetrabenazine, a certain||
6154|169|I|combination product (dextromethorphan/quinidine), maprotiline,||
6154|170|I|methyldopa, metoclopramide, certain opioid pain relievers (such||
6154|171|I|as fentanyl, meperidine, methadone, tapentadol), certain drugs||
6154|172|I|for Parkinson's disease (such as entacapone, levodopa,||
6154|173|I|tolcapone), certain supplements (such as tryptophan, tyramine),||
6154|174|I|tetrabenazine, tricyclic antidepressants (such as amitriptyline,||
6154|175|I|doxepin), valbenazine.||
6154|176|I|   The risk of serotonin syndrome/toxicity increases if you are||
6154|177|I|also taking other drugs that increase serotonin. Examples include||
6154|178|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
6154|179|I|antidepressants (including mirtazapine, SSRIs such as||
6154|180|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
6154|181|I|tramadol, certain "triptans" used to treat migraine headaches||
6154|182|I|(such as rizatriptan, sumatriptan, zolmitriptan), among others.||
6154|183|I|The risk of serotonin syndrome/toxicity may be more likely when||
6154|184|I|you start or increase the dose of these drugs.||
6154|185|I|   Some products can interact with linezolid if you take them||
6154|186|I|together, or even if you take them weeks before or after taking||
6154|187|I|linezolid. Tell your doctor or pharmacist if you take anything in||
6154|188|I|the list of products that may interact with this drug, or any of||
6154|189|I|the products that increase serotonin, within 2 weeks before or||
6154|190|I|after taking linezolid. Also tell them if you have taken||
6154|191|I|fluoxetine within 5 weeks before starting linezolid. Ask your||
6154|192|I|doctor how much time to wait between starting or stopping any of||
6154|193|I|these drugs and starting linezolid.||
6154|194|I|   Taking other MAO inhibitors with this medication may cause a||
6154|195|I|serious (possibly fatal) drug interaction. Do not take any other||
6154|196|I|MAO inhibitors (isocarboxazid, metaxalone, methylene blue,||
6154|197|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
6154|198|I|selegiline, tranylcypromine) during treatment with this||
6154|199|I|medication. Most MAO inhibitors should also not be taken for two||
6154|200|I|weeks before and after treatment with this medication. Ask your||
6154|201|I|doctor when to start or stop taking this medication.||
6154|202|I|   Before using linezolid, report the use of drugs that may||
6154|203|I|increase the risk of extremely high blood pressure (hypertensive||
6154|204|I|crisis) when combined with linezolid, including herbal products||
6154|205|I|(such as ephedra/ma huang), allergy and cold products (including||
6154|206|I|decongestants such as phenylephrine/pseudoephedrine), and||
6154|207|I|stimulants (such as amphetamines, ephedrine, epinephrine).||
6154|208|I|Linezolid should not be used with any of these medications. Talk||
6154|209|I|to your doctor or pharmacist for more details.||
6154|210|B|||
6154|211|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6154|212|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6154|213|O|poison control center right away. US residents can call||
6154|214|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6154|215|B|||
6154|216|N|NOTES:  Do not share this medication with others.||
6154|217|N|   This medication has been prescribed for your current condition||
6154|218|N|only. Do not use it later for another infection unless your||
6154|219|N|doctor tells you to.||
6154|220|N|   Lab and/or medical tests (such as complete blood count, blood||
6154|221|N|sodium levels) may be done while you are taking this medication.||
6154|222|N|Eye tests should also be done if you take linezolid for 3 months||
6154|223|N|or more, or if you have vision changes. Keep all medical and lab||
6154|224|N|appointments.||
6154|225|B|||
6154|226|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6154|227|D|remember. If it is near the time of the next dose, skip the||
6154|228|D|missed dose. Take your next dose at the regular time. Do not||
6154|229|D|double the dose to catch up.||
6154|230|B|||
6154|231|R|STORAGE:  Store at room temperature away from light and moisture.||
6154|232|R|Do not store in the bathroom. Keep all medications away from||
6154|233|R|children and pets.||
6154|234|R|   Do not flush medications down the toilet or pour them into a||
6154|235|R|drain unless instructed to do so. Properly discard this product||
6154|236|R|when it is expired or no longer needed. Consult your pharmacist||
6154|237|R|or local waste disposal company.||
6154|238|B|||
6154|239|A|Information last revised August 2024.||
6154|240|A|Copyright(c) 2025 First Databank, Inc.||
6154|241|B|||
6156|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6156|002|Z|does NOT have all possible information about this product. This||
6156|003|Z|information does not assure that this product is safe, effective,||
6156|004|Z|or appropriate for you. This information is not individual||
6156|005|Z|medical advice and does not substitute for the advice of your||
6156|006|Z|health care professional. Always ask your health care||
6156|007|Z|professional for complete information about this product and your||
6156|008|Z|specific health needs.||
6156|009|B|||
6156|010|T|SODIUM FLUORIDE 1.1% DENTAL GEL - TOPICAL||
6156|011|F|(SOE-dee-um FLOOR-ide)||
6156|012|B|||
6156|013|C|COMMON BRAND NAME(S): Karidium, Karigel, Prevident||
6156|014|B|||
6156|015|U|USES:  This medication is used to prevent cavities. It makes||
6156|016|U|teeth stronger and more resistant to decay caused by acid and||
6156|017|U|bacteria.||
6156|018|B|||
6156|019|H|HOW TO USE:  Use this medication as directed by your||
6156|020|H|doctor/dentist, usually once daily just before bedtime.||
6156|021|H|   First brush your teeth thoroughly with toothpaste, and rinse||
6156|022|H|as usual. Then apply a thin ribbon of this medication to your||
6156|023|H|teeth with a toothbrush or mouth tray. Leave the medication on||
6156|024|H|for at least 1 minute.||
6156|025|H|   Spit out the medication after use. Do not swallow. Children||
6156|026|H|should rinse their mouth thoroughly right away. For adults, do||
6156|027|H|not rinse your mouth, eat, or drink for at least 30 minutes after||
6156|028|H|use to get the best results.||
6156|029|H|   Use this medication regularly in order to get the most benefit||
6156|030|H|from it. To help you remember, use it at the same time each day.||
6156|031|B|||
6156|032|S|SIDE EFFECTS:  Mouth/gum irritation may rarely occur. If this||
6156|033|S|effect lasts or gets worse, tell your doctor/dentist or||
6156|034|S|pharmacist promptly.||
6156|035|S|   Tell your doctor/dentist right away if your teeth become||
6156|036|S|stained or pitted. This is often a result of too much fluoride.||
6156|037|S|   Remember that this medication has been prescribed because your||
6156|038|S|doctor or dentist has judged that the benefit to you is greater||
6156|039|S|than the risk of side effects. Many people using this medication||
6156|040|S|do not have serious side effects.||
6156|041|S|   A very serious allergic reaction to this drug is rare.||
6156|042|S|However, get medical help right away if you notice any symptoms||
6156|043|S|of a serious allergic reaction, including: rash, itching/swelling||
6156|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6156|045|S|breathing.||
6156|046|S|   This is not a complete list of possible side effects. If you||
6156|047|S|notice other effects not listed above, contact your||
6156|048|S|doctor/dentist or pharmacist.||
6156|049|S|   In the US -||
6156|050|S|   Call your doctor for medical advice about side effects. You||
6156|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6156|052|S|www.fda.gov/medwatch.||
6156|053|S|   In Canada - Call your doctor for medical advice about side||
6156|054|S|effects. You may report side effects to Health Canada at||
6156|055|S|1-866-234-2345.||
6156|056|B|||
6156|057|P|PRECAUTIONS:  Before using this medication, tell your||
6156|058|P|doctor/dentist or pharmacist if you are allergic to it; or if you||
6156|059|P|have any other allergies. This product may contain inactive||
6156|060|P|ingredients, which can cause allergic reactions or other||
6156|061|P|problems. Talk to your pharmacist for more details.||
6156|062|P|   Before using this medication, tell your doctor/dentist or||
6156|063|P|pharmacist your medical history, especially of: mouth problems||
6156|064|P|(such as sores, mucositis).||
6156|065|P|   Children may be more sensitive to the side effects of this||
6156|066|P|drug, especially if this medication is swallowed. Watch children||
6156|067|P|closely when they are using this medication to make sure that||
6156|068|P|they do not swallow this medication.||
6156|069|P|   Tell your doctor if you are pregnant before using this||
6156|070|P|medication.||
6156|071|P|   It is unknown if this drug passes into breast milk. Consult||
6156|072|P|your healthcare professional before breastfeeding.||
6156|073|B|||
6156|074|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6156|075|I|medications work or increase your risk for serious side effects.||
6156|076|I|This document does not contain all possible drug interactions.||
6156|077|I|Keep a list of all the products you use (including||
6156|078|I|prescription/nonprescription drugs and herbal products) and share||
6156|079|I|it with your doctor and pharmacist. Do not start, stop, or change||
6156|080|I|the dosage of any medicines without your doctor's approval.||
6156|081|B|||
6156|082|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6156|083|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6156|084|O|poison control center right away. US residents can call||
6156|085|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6156|086|O|Symptoms of overdose may include: burning in the mouth, sore||
6156|087|O|tongue, nausea, vomiting, diarrhea, increased saliva, stomach||
6156|088|O|pain/cramping, muscle weakness, shaking, seizures.||
6156|089|B|||
6156|090|N|NOTES:  Do not share this medication with others.||
6156|091|N|   Using this medication does not replace good dental habits.||
6156|092|N|Continue to brush and floss your teeth regularly as directed by||
6156|093|N|your dentist, and have regular dental checkups.||
6156|094|B|||
6156|095|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6156|096|D|If it is near the time of the next dose, skip the missed dose.||
6156|097|D|Use your next dose at the regular time. Do not double the dose to||
6156|098|D|catch up.||
6156|099|B|||
6156|100|R|STORAGE:  Store at room temperature away from heat. Keep all||
6156|101|R|medications away from children and pets.||
6156|102|R|   Do not flush medications down the toilet or pour them into a||
6156|103|R|drain unless instructed to do so. Properly discard this product||
6156|104|R|when it is expired or no longer needed. Consult your pharmacist||
6156|105|R|or local waste disposal company.||
6156|106|B|||
6156|107|A|Information last revised May 2024.||
6156|108|A|Copyright(c) 2025 First Databank, Inc.||
6156|109|B|||
6170|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6170|002|Z|does NOT have all possible information about this product. This||
6170|003|Z|information does not assure that this product is safe, effective,||
6170|004|Z|or appropriate for you. This information is not individual||
6170|005|Z|medical advice and does not substitute for the advice of your||
6170|006|Z|health care professional. Always ask your health care||
6170|007|Z|professional for complete information about this product and your||
6170|008|Z|specific health needs.||
6170|009|B|||
6170|010|T|PRAMOXINE/HYDROCORTISONE LOTION - TOPICAL||
6170|011|F|(pram-OX-een/HYE-droe-KOR-ti-sone)||
6170|012|B|||
6170|013|C|COMMON BRAND NAME(S): Pramosone||
6170|014|B|||
6170|015|U|USES:  Pramoxine is an anesthetic used on the skin to relieve||
6170|016|U|minor pain, itching, and discomfort. Hydrocortisone is a||
6170|017|U|corticosteroid that reduces redness, swelling, and itching. This||
6170|018|U|combination medication is used to treat certain skin conditions||
6170|019|U|such as eczema, rash, scrapes, insect bites, or minor burns.||
6170|020|U|   This combination product for the skin is available in||
6170|021|U|different strengths and forms (such as creams, ointments, and||
6170|022|U|lotions). The type of medication used depends on the location of||
6170|023|U|your condition and the type of skin problem being treated. Creams||
6170|024|U|are the most often used form. Lotions may be better suited to||
6170|025|U|hairy areas. Ointments may be better suited for dry areas and||
6170|026|U|when a stronger effect or skin protection is desired.||
6170|027|B|||
6170|028|H|HOW TO USE:  Shake the bottle well before each dose. Before||
6170|029|H|applying the medication, clean the affected area with mild soap||
6170|030|H|and water, rinse well, and pat dry. Gently rub a small amount of||
6170|031|H|the medication into the affected area and surrounding skin in a||
6170|032|H|thin layer as directed by your doctor, usually 3 to 4 times a||
6170|033|H|day. How often the medication is applied and for how long depends||
6170|034|H|on your condition and response to treatment.||
6170|035|H|   Wash hands immediately after use unless the area being treated||
6170|036|H|includes the hands. Avoid getting the product in your eyes, nose,||
6170|037|H|ears, or mouth. If the medication gets in these areas, rinse||
6170|038|H|immediately with clean water.||
6170|039|H|   Do not cover the area with waterproof bandages or plastic,||
6170|040|H|apply heat, or use the product on large areas of the body unless||
6170|041|H|directed to do so by your doctor. If used in the diaper area on||
6170|042|H|an infant, do not use tight-fitting diapers or plastic pants.||
6170|043|H|This may increase the risk of side effects.||
6170|044|H|   Use this medication regularly in order to get the most benefit||
6170|045|H|from it. To help you remember, use it at the same times each day.||
6170|046|H|   Do not use more of this product, use it more often, or keep||
6170|047|H|using it longer than prescribed by your doctor. If you have been||
6170|048|H|using this medication for a long time or in high doses, do not||
6170|049|H|suddenly stop using it without your doctor's approval. Some||
6170|050|H|conditions may become worse when this drug is suddenly stopped.||
6170|051|H|Your dose may need to be gradually decreased.||
6170|052|H|   Tell your doctor if your condition does not get better or if||
6170|053|H|it gets worse.||
6170|054|B|||
6170|055|S|SIDE EFFECTS:  Redness, burning, or itching at the application||
6170|056|S|site may occur. If any of these effects last or get worse, tell||
6170|057|S|your doctor or pharmacist promptly.||
6170|058|S|   Remember that this medication has been prescribed because your||
6170|059|S|doctor has judged that the benefit to you is greater than the||
6170|060|S|risk of side effects. Many people using this medication do not||
6170|061|S|have serious side effects.||
6170|062|S|   Tell your doctor right away if you have any serious side||
6170|063|S|effects, including: change in skin appearance (such as color,||
6170|064|S|thickness), signs of skin infection (such as heat, tenderness,||
6170|065|S|pus), signs of infection (such as sore throat that doesn't go||
6170|066|S|away, fever, chills).||
6170|067|S|   A very serious allergic reaction to this drug is rare.||
6170|068|S|However, get medical help right away if you notice any symptoms||
6170|069|S|of a serious allergic reaction, including: rash, itching/swelling||
6170|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6170|071|S|breathing.||
6170|072|S|   This is not a complete list of possible side effects. If you||
6170|073|S|notice other effects not listed above, contact your doctor or||
6170|074|S|pharmacist.||
6170|075|S|   In the US -||
6170|076|S|   Call your doctor for medical advice about side effects. You||
6170|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6170|078|S|www.fda.gov/medwatch.||
6170|079|S|   In Canada - Call your doctor for medical advice about side||
6170|080|S|effects. You may report side effects to Health Canada at||
6170|081|S|1-866-234-2345.||
6170|082|B|||
6170|083|P|PRECAUTIONS:  Before using this product, tell your doctor or||
6170|084|P|pharmacist if you are allergic to pramoxine; or to||
6170|085|P|hydrocortisone; or if you have any other allergies. This product||
6170|086|P|may contain inactive ingredients, which can cause allergic||
6170|087|P|reactions or other problems. Talk to your pharmacist for more||
6170|088|P|details.||
6170|089|P|   Before using this medication, tell your doctor or pharmacist||
6170|090|P|your medical history, especially of: diabetes, eye problems,||
6170|091|P|infections (especially skin infections), liver disease.||
6170|092|P|   Children may be more sensitive to the effects of too much||
6170|093|P|corticosteroid medication. Consult your doctor for more details||
6170|094|P|   During pregnancy, this medication should be used only when||
6170|095|P|clearly needed. It should not be used for long periods of time or||
6170|096|P|in large amounts. Discuss the risks and benefits with your||
6170|097|P|doctor.||
6170|098|P|   It is unknown if this medication passes into breast milk.||
6170|099|P|Consult your doctor before breastfeeding.||
6170|100|B|||
6170|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6170|102|I|medications work or increase your risk for serious side effects.||
6170|103|I|This document does not contain all possible drug interactions.||
6170|104|I|Keep a list of all the products you use (including||
6170|105|I|prescription/nonprescription drugs and herbal products) and share||
6170|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
6170|107|I|the dosage of any medicines without your doctor's approval.||
6170|108|B|||
6170|109|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6170|110|O|has overdosed and has serious symptoms such as passing out or||
6170|111|O|trouble breathing, call 911. Otherwise, call a poison control||
6170|112|O|center right away. US residents can call 1-800-222-1222. Canada||
6170|113|O|residents can call 1-844-764-7669.||
6170|114|B|||
6170|115|N|NOTES:  Do not share this medication with others.||
6170|116|N|   Use this medication for your current condition only. Do not||
6170|117|N|use it later for other skin problems unless told to do so by your||
6170|118|N|doctor. A different medication may be necessary in those cases.||
6170|119|B|||
6170|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6170|121|D|If it is near the time of the next dose, skip the missed dose.||
6170|122|D|Use your next dose at the regular time. Do not double the dose to||
6170|123|D|catch up.||
6170|124|B|||
6170|125|R|STORAGE:  Store at room temperature. Keep all medications away||
6170|126|R|from children and pets.||
6170|127|R|   Do not flush medications down the toilet or pour them into a||
6170|128|R|drain unless instructed to do so. Properly discard this product||
6170|129|R|when it is expired or no longer needed. Consult your pharmacist||
6170|130|R|or local waste disposal company.||
6170|131|B|||
6170|132|A|Information last revised May 2025.||
6170|133|A|Copyright(c) 2025 First Databank, Inc.||
6170|134|B|||
6171|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6171|002|Z|does NOT have all possible information about this product. This||
6171|003|Z|information does not assure that this product is safe, effective,||
6171|004|Z|or appropriate for you. This information is not individual||
6171|005|Z|medical advice and does not substitute for the advice of your||
6171|006|Z|health care professional. Always ask your health care||
6171|007|Z|professional for complete information about this product and your||
6171|008|Z|specific health needs.||
6171|009|B|||
6171|010|T|ACETIC ACID W/HYDROCORTISONE - OTIC||
6171|011|F|(a-SEE-tik AS-id/HYE-droe-KOR-ti-sone)||
6171|012|B|||
6171|013|C|COMMON BRAND NAME(S): Acetasol HC, Vosol HC||
6171|014|B|||
6171|015|U|USES:  This combination medication is used to treat outer ear||
6171|016|U|infections (such as swimmer's ear). This product contains 2||
6171|017|U|medications. Acetic acid works by stopping the growth of bacteria||
6171|018|U|and fungus. Hydrocortisone is a steroid that helps to decrease||
6171|019|U|the redness, swelling, and itching from the infection.||
6171|020|B|||
6171|021|H|HOW TO USE:  Clean the ear and carefully remove all earwax and||
6171|022|H|other substances from the outer ear. To apply ear drops, wash||
6171|023|H|your hands first. To avoid contamination, do not touch the||
6171|024|H|dropper tip or let it touch your ear or any other surface.||
6171|025|H|   To make sure that the right amount of medication is given, and||
6171|026|H|to avoid touching the ear with the dropper, have another person||
6171|027|H|insert the drops if possible. To lower the risk of dizziness,||
6171|028|H|hold the container in your hand for a few minutes in order to||
6171|029|H|warm it.||
6171|030|H|   For at least the first 24 hours of treatment or as directed by||
6171|031|H|your doctor, put a cotton plug soaked with the solution in the||
6171|032|H|affected ear(s). You may put the cotton plug in your ear first||
6171|033|H|and then apply the ear drops onto the cotton plug. Keep the plug||
6171|034|H|moist by adding 3 to 5 drops of the medication as directed by||
6171|035|H|your doctor, usually every 4 to 6 hours.||
6171|036|H|   After removing the plug, continue to apply the medication||
6171|037|H|directly into the ear as directed by your doctor, usually 3 to 4||
6171|038|H|times daily. Lie on your side or tilt the affected ear upward.||
6171|039|H|Hold the dropper directly over the ear, and place the prescribed||
6171|040|H|number of drops into the ear canal. To help the drops roll into||
6171|041|H|the ear of an adult, hold the earlobe up and back. In children,||
6171|042|H|hold the earlobe down and back. Keep the head tilted for about 2||
6171|043|H|minutes. Repeat for the other ear if so directed. Do not rinse||
6171|044|H|the dropper. Replace the cap after use.||
6171|045|H|   Use this medication regularly to get the most benefit from it.||
6171|046|H|To help you remember, use it at the same times each day. Continue||
6171|047|H|to use this medication for the full time prescribed, even if||
6171|048|H|symptoms disappear after a few days. Stopping the medication too||
6171|049|H|early may result in a return of the infection.||
6171|050|H|   Do not use this medication more often or longer than||
6171|051|H|prescribed. Unnecessary use or misuse of this medication can lead||
6171|052|H|to its decreased effectiveness.||
6171|053|H|   Do not use in the eye.||
6171|054|H|   Tell your doctor if your condition does not get better or if||
6171|055|H|it gets worse.||
6171|056|B|||
6171|057|S|SIDE EFFECTS:  Temporary stinging and burning may occur when the||
6171|058|S|medication is first dropped into the ear. If any of these effects||
6171|059|S|last or get worse, tell your doctor or pharmacist promptly.||
6171|060|S|   Remember that this medication has been prescribed because your||
6171|061|S|doctor has judged that the benefit to you is greater than the||
6171|062|S|risk of side effects. Many people using this medication do not||
6171|063|S|have serious side effects.||
6171|064|S|   Tell your doctor right away if you have any serious side||
6171|065|S|effects, including: increased or new redness/swelling/pain in or||
6171|066|S|around the ears.||
6171|067|S|   A very serious allergic reaction to this drug is rare.||
6171|068|S|However, get medical help right away if you notice any symptoms||
6171|069|S|of a serious allergic reaction, including: rash, itching/swelling||
6171|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6171|071|S|breathing.||
6171|072|S|   This is not a complete list of possible side effects. If you||
6171|073|S|notice other effects not listed above, contact your doctor or||
6171|074|S|pharmacist.||
6171|075|S|   In the US -||
6171|076|S|   Call your doctor for medical advice about side effects. You||
6171|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6171|078|S|www.fda.gov/medwatch.||
6171|079|S|   In Canada - Call your doctor for medical advice about side||
6171|080|S|effects. You may report side effects to Health Canada at||
6171|081|S|1-866-234-2345.||
6171|082|B|||
6171|083|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6171|084|P|pharmacist if you are allergic to acetic acid or hydrocortisone;||
6171|085|P|or to other corticosteroids (such as betamethasone); or if you||
6171|086|P|have any other allergies. This product may contain inactive||
6171|087|P|ingredients, which can cause allergic reactions or other||
6171|088|P|problems. Talk to your pharmacist for more details.||
6171|089|P|   Before using this medication, tell your doctor or pharmacist||
6171|090|P|your medical history, especially of: hole in the eardrum||
6171|091|P|(perforated tympanic membrane), certain viral infections (such as||
6171|092|P|herpes simplex, vaccinia, chickenpox), ear injuries/surgeries.||
6171|093|P|   During pregnancy, this medication should be used only when||
6171|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
6171|095|P|   It is unknown if this drug passes into breast milk. Consult||
6171|096|P|your doctor before breastfeeding.||
6171|097|B|||
6171|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6171|099|I|medications work or increase your risk for serious side effects.||
6171|100|I|This document does not contain all possible drug interactions.||
6171|101|I|Keep a list of all the products you use (including||
6171|102|I|prescription/nonprescription drugs and herbal products) and share||
6171|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
6171|104|I|the dosage of any medicines without your doctor's approval.||
6171|105|B|||
6171|106|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6171|107|O|has overdosed and has serious symptoms such as passing out or||
6171|108|O|trouble breathing, call 911. Otherwise, call a poison control||
6171|109|O|center right away. US residents can call 1-800-222-1222. Canada||
6171|110|O|residents can call 1-844-764-7669.||
6171|111|B|||
6171|112|N|NOTES:  Do not share this medication with others.||
6171|113|N|   This medication has been prescribed for your current condition||
6171|114|N|only. Do not use it later for another infection unless your||
6171|115|N|doctor tells you to.||
6171|116|N|   It is important to keep the infected ear(s) clean and dry. Try||
6171|117|N|not to get the infected ear(s) wet when bathing. Avoid swimming||
6171|118|N|unless your doctor tells you otherwise.||
6171|119|B|||
6171|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6171|121|D|If it is near the time of the next dose, skip the missed dose.||
6171|122|D|Use your next dose at the regular time. Do not double the dose to||
6171|123|D|catch up.||
6171|124|B|||
6171|125|R|STORAGE:  Store at room temperature away from light. Keep all||
6171|126|R|medications away from children and pets.||
6171|127|R|   Do not flush medications down the toilet or pour them into a||
6171|128|R|drain unless instructed to do so. Properly discard this product||
6171|129|R|when it is expired or no longer needed. Consult your pharmacist||
6171|130|R|or local waste disposal company.||
6171|131|B|||
6171|132|A|Information last revised November 2024.||
6171|133|A|Copyright(c) 2025 First Databank, Inc.||
6171|134|B|||
6174|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6174|002|Z|does NOT have all possible information about this product. This||
6174|003|Z|information does not assure that this product is safe, effective,||
6174|004|Z|or appropriate for you. This information is not individual||
6174|005|Z|medical advice and does not substitute for the advice of your||
6174|006|Z|health care professional. Always ask your health care||
6174|007|Z|professional for complete information about this product and your||
6174|008|Z|specific health needs.||
6174|009|B|||
6174|010|T|PAMIDRONATE - INJECTION||
6174|011|F|(PAM-i-DROE-nate)||
6174|012|B|||
6174|013|C|COMMON BRAND NAME(S): Aredia||
6174|014|B|||
6174|015|U|USES:  Pamidronate is used to treat high blood calcium levels and||
6174|016|U|certain bone problems (bone metastases/lesions) that may occur||
6174|017|U|with some types of cancer. It is also used to treat a certain||
6174|018|U|type of bone disease (Paget's disease) that causes abnormal and||
6174|019|U|weak bones.||
6174|020|U|   Pamidronate belongs to a class of drugs known as||
6174|021|U|bisphosphonates. It works by slowing the release of calcium from||
6174|022|U|bones to lower blood calcium levels, reducing the risk of broken||
6174|023|U|bones (fractures) and reducing bone pain.||
6174|024|B|||
6174|025|H|HOW TO USE:  This medication is given by slow injection into a||
6174|026|H|vein as directed by your doctor. The dosage is based on your||
6174|027|H|medical condition, lab tests, and response to treatment.||
6174|028|H|   If you are giving this medication to yourself at home, learn||
6174|029|H|all preparation and usage instructions from your health care||
6174|030|H|professional. Before using, check this product for particles or||
6174|031|H|discoloration. If either is present, do not use the liquid. Learn||
6174|032|H|how to store and discard medical supplies safely.||
6174|033|H|   During treatment with this medication, it is important that||
6174|034|H|you take in plenty of fluids and pass urine often to help avoid||
6174|035|H|kidney problems. Intravenous fluids are usually given with this||
6174|036|H|medication. Ask your doctor how much fluid you should drink, and||
6174|037|H|follow these instructions carefully.||
6174|038|B|||
6174|039|S|SIDE EFFECTS:  Flu-like symptoms (such as mild fever, chills,||
6174|040|S|tiredness, muscle/joint aches) may occur after treatment. Most of||
6174|041|S|these effects are mild and can last up to 48 hours. Bone pain,||
6174|042|S|redness/swelling/pain at the infusion site, headache, dizziness,||
6174|043|S|loss of appetite, nausea, vomiting, diarrhea, drowsiness or||
6174|044|S|trouble sleeping may also occur. If any of these effects last or||
6174|045|S|get worse, tell your doctor or pharmacist promptly.||
6174|046|S|   Remember that this medication has been prescribed because your||
6174|047|S|doctor has judged that the benefit to you is greater than the||
6174|048|S|risk of side effects. Many people using this medication do not||
6174|049|S|have serious side effects.||
6174|050|S|   Tell your doctor right away if you experience any symptoms of||
6174|051|S|low calcium such as muscle spasms or numbness/tingling||
6174|052|S|(especially around the lips/mouth). Your doctor may ask you to||
6174|053|S|take calcium and vitamin D supplements to prevent low blood||
6174|054|S|calcium levels after treatment.||
6174|055|S|   Tell your doctor right away if you have any serious side||
6174|056|S|effects, including: sores in jaw/mouth, jaw pain, increased or||
6174|057|S|severe bone/joint/muscle pain, new or unusual hip/thigh/groin||
6174|058|S|pain, eye problems (such as redness/itching/swelling or||
6174|059|S|sensitivity to light), signs of kidney problems (such as change||
6174|060|S|in the amount of urine), unusual tiredness/weakness, mental/mood||
6174|061|S|changes (such as irritability or confusion),||
6174|062|S|fast/pounding/irregular heartbeat.||
6174|063|S|   A very serious allergic reaction to this drug is rare.||
6174|064|S|However, get medical help right away if you notice any symptoms||
6174|065|S|of a serious allergic reaction, including: rash, itching/swelling||
6174|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6174|067|S|breathing.||
6174|068|S|   This is not a complete list of possible side effects. If you||
6174|069|S|notice other effects not listed above, contact your doctor or||
6174|070|S|pharmacist.||
6174|071|S|   In the US -||
6174|072|S|   Call your doctor for medical advice about side effects. You||
6174|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6174|074|S|www.fda.gov/medwatch.||
6174|075|S|   In Canada - Call your doctor for medical advice about side||
6174|076|S|effects. You may report side effects to Health Canada at||
6174|077|S|1-866-234-2345.||
6174|078|B|||
6174|079|P|PRECAUTIONS:  Before using pamidronate, tell your doctor or||
6174|080|P|pharmacist if you are allergic to it; or other bisphosphonates||
6174|081|P|(such as alendronate); or if you have any other allergies. This||
6174|082|P|product may contain inactive ingredients, which can cause||
6174|083|P|allergic reactions or other problems. Talk to your pharmacist for||
6174|084|P|more details.||
6174|085|P|   Before using this medication, tell your doctor or pharmacist||
6174|086|P|your medical history, especially of: recent or planned dental||
6174|087|P|procedures (such as tooth removal), parathyroid/thyroid surgery,||
6174|088|P|kidney problems, dehydration, heart failure.||
6174|089|P|   Some people using pamidronate may have serious jawbone||
6174|090|P|problems. Your doctor should check your mouth before you start||
6174|091|P|this medication. Tell your dentist that you are using this||
6174|092|P|medication before you have any dental work done. To help prevent||
6174|093|P|jawbone problems, have regular dental exams and learn how to keep||
6174|094|P|your teeth and gums healthy. If you have jaw pain, tell your||
6174|095|P|doctor and dentist right away.||
6174|096|P|   Before having any surgery (especially dental procedures), tell||
6174|097|P|your doctor and dentist about this medication and all other||
6174|098|P|products you use (including prescription drugs, nonprescription||
6174|099|P|drugs, and herbal products). Your doctor or dentist may tell you||
6174|100|P|to stop taking pamidronate before your surgery. Ask for specific||
6174|101|P|instructions about stopping or starting this medication.||
6174|102|P|   This drug may rarely make you dizzy or drowsy. Alcohol or||
6174|103|P|marijuana (cannabis) can make you more dizzy or drowsy. Do not||
6174|104|P|drive, use machinery, or do anything that needs alertness until||
6174|105|P|you can do it safely. Limit alcoholic beverages. Talk to your||
6174|106|P|doctor if you are using marijuana (cannabis).||
6174|107|P|   Tell your doctor if you are pregnant or plan to become||
6174|108|P|pregnant. Pamidronate may stay in your body for many years. You||
6174|109|P|should not become pregnant while using pamidronate. Pamidronate||
6174|110|P|may harm an unborn baby. Your doctor should order a pregnancy||
6174|111|P|test before you start this medication. Ask about reliable forms||
6174|112|P|of birth control while using this medication and for some time||
6174|113|P|after the last dose. If you become pregnant, talk to your doctor||
6174|114|P|right away about the risks and benefits of this medication.||
6174|115|P|   This medication passes into breast milk. Consult your doctor||
6174|116|P|before breastfeeding.||
6174|117|B|||
6174|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6174|119|I|medications work or increase your risk for serious side effects.||
6174|120|I|This document does not contain all possible drug interactions.||
6174|121|I|Keep a list of all the products you use (including||
6174|122|I|prescription/nonprescription drugs and herbal products) and share||
6174|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
6174|124|I|the dosage of any medicines without your doctor's approval.||
6174|125|I|   Some products that may interact with this drug include: other||
6174|126|I|bisphosphonates (such as alendronate), other medications which||
6174|127|I|may affect the kidneys (including NSAIDs such as ibuprofen or||
6174|128|I|naproxen).||
6174|129|B|||
6174|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6174|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6174|132|O|poison control center right away. US residents can call||
6174|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6174|134|O|Symptoms of overdose may include: muscle spasms or||
6174|135|O|numbness/tingling (especially around the lips/mouth).||
6174|136|B|||
6174|137|N|NOTES:  Lab and/or medical tests (such as calcium, magnesium,||
6174|138|N|phosphate, and potassium blood levels, complete blood count,||
6174|139|N|albumin, kidney function) should be done while you are using this||
6174|140|N|medication. Keep all medical and lab appointments. Consult your||
6174|141|N|doctor for more details.||
6174|142|B|||
6174|143|D|MISSED DOSE:  It is important to get each dose of this medication||
6174|144|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6174|145|D|right away for a new dosing schedule. Do not double the dose to||
6174|146|D|catch up.||
6174|147|B|||
6174|148|R|STORAGE:  Consult the product instructions and your pharmacist||
6174|149|R|for storage details. Keep all medications away from children and||
6174|150|R|pets.||
6174|151|R|   Do not flush medications down the toilet or pour them into a||
6174|152|R|drain unless instructed to do so. Properly discard this product||
6174|153|R|when it is expired or no longer needed. Consult your pharmacist||
6174|154|R|or local waste disposal company.||
6174|155|B|||
6174|156|A|Information last revised November 2025.||
6174|157|A|Copyright(c) 2025 First Databank, Inc.||
6174|158|B|||
6179|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6179|002|Z|does NOT have all possible information about this product. This||
6179|003|Z|information does not assure that this product is safe, effective,||
6179|004|Z|or appropriate for you. This information is not individual||
6179|005|Z|medical advice and does not substitute for the advice of your||
6179|006|Z|health care professional. Always ask your health care||
6179|007|Z|professional for complete information about this product and your||
6179|008|Z|specific health needs.||
6179|009|B|||
6179|010|T|CLOTRIMAZOLE/BETAMETHASONE - TOPICAL||
6179|011|F|(kloe-TRIM-a-zole/BAY-ta-METH-a-sone)||
6179|012|B|||
6179|013|C|COMMON BRAND NAME(S): Lotrisone||
6179|014|B|||
6179|015|U|USES:  This combination medication is used to treat a variety of||
6179|016|U|inflamed fungal skin infections such as ringworm, athlete's foot,||
6179|017|U|and jock itch. This product contains 2 medications. Clotrimazole||
6179|018|U|is an azole antifungal that works by preventing the growth of||
6179|019|U|fungus. Betamethasone is a strong corticosteroid that works by||
6179|020|U|reducing the swelling, redness, and itching that occurs in the||
6179|021|U|skin infection.||
6179|022|U|   This medication is not recommended for children younger than||
6179|023|U|17 years or for diaper rash.||
6179|024|B|||
6179|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6179|026|H|from your pharmacist before you start using this medication and||
6179|027|H|each time you get a refill. If you have any questions, ask your||
6179|028|H|doctor or pharmacist.||
6179|029|H|   If you are using the lotion form of this medication, shake the||
6179|030|H|bottle well before each use.||
6179|031|H|   Use this medication on the skin only. Clean and thoroughly dry||
6179|032|H|the area to be treated. Apply a thin layer of the medication to||
6179|033|H|the affected area and gently rub in as directed by your doctor,||
6179|034|H|usually twice daily (in the morning and evening). Wash your hands||
6179|035|H|after using unless you are using this medication to treat the||
6179|036|H|hands. Do not wrap, cover, or bandage the area unless directed to||
6179|037|H|do so by your doctor. Wear loose-fitting clothes after applying||
6179|038|H|the medication to the groin area.||
6179|039|H|   Do not apply the medication in the eyes, nose, mouth, or||
6179|040|H|inside the vagina. If you do get the medication in those areas,||
6179|041|H|flush with plenty of water.||
6179|042|H|   The dosage and length of treatment depends on the type of||
6179|043|H|infection being treated. Ringworm or jock itch is usually treated||
6179|044|H|for 2 weeks, and athlete's foot is usually treated for 4 weeks.||
6179|045|H|Do not use more than 45 grams of the cream or 45 milliliters of||
6179|046|H|the lotion per week unless directed and closely monitored by your||
6179|047|H|doctor.||
6179|048|H|   Do not apply more often or use longer than prescribed. This||
6179|049|H|may increase the risk of side effects.||
6179|050|H|   Use this medication regularly to get the most benefit from it.||
6179|051|H|To help you remember, use it at the same times each day.||
6179|052|H|   Continue to use this medication until the full prescribed||
6179|053|H|amount is finished, even if symptoms disappear after a few days.||
6179|054|H|Stopping the medication too early may result in a return of the||
6179|055|H|infection.||
6179|056|H|   Tell your doctor if your condition gets worse or if it does||
6179|057|H|not get better after 1 week of treatment for jock itch or||
6179|058|H|ringworm or 2 weeks of treatment for athlete's foot.||
6179|059|B|||
6179|060|S|SIDE EFFECTS:  Burning, tingling, dry skin, or stinging may||
6179|061|S|occur. If any of these effects last or get worse, tell your||
6179|062|S|doctor or pharmacist promptly.||
6179|063|S|   Remember that this medication has been prescribed because your||
6179|064|S|doctor has judged that the benefit to you is greater than the||
6179|065|S|risk of side effects. Many people using this medication do not||
6179|066|S|have serious side effects.||
6179|067|S|   Tell your doctor right away if you have any serious side||
6179|068|S|effects, including: extreme hair growth, skin||
6179|069|S|thinning/discoloration, acne, stretch marks, small red bumps on||
6179|070|S|the skin (folliculitis).||
6179|071|S|   Rarely, it is possible this medication will be absorbed from||
6179|072|S|the skin into the bloodstream. This can lead to side effects of||
6179|073|S|too much corticosteroid. These side effects are more likely in||
6179|074|S|children, and in people who use this medication for a long time||
6179|075|S|or over large areas of the skin. Tell your doctor right away if||
6179|076|S|any of the following side effects occur: unusual/extreme||
6179|077|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
6179|078|S|thirst/urination, vision problems.||
6179|079|S|   A very serious allergic reaction to this drug is rare.||
6179|080|S|However, get medical help right away if you notice any symptoms||
6179|081|S|of a serious allergic reaction, including: rash, itching/swelling||
6179|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6179|083|S|breathing.||
6179|084|S|   This is not a complete list of possible side effects. If you||
6179|085|S|notice other effects not listed above, contact your doctor or||
6179|086|S|pharmacist.||
6179|087|S|   In the US -||
6179|088|S|   Call your doctor for medical advice about side effects. You||
6179|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6179|090|S|www.fda.gov/medwatch.||
6179|091|S|   In Canada - Call your doctor for medical advice about side||
6179|092|S|effects. You may report side effects to Health Canada at||
6179|093|S|1-866-234-2345.||
6179|094|B|||
6179|095|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6179|096|P|pharmacist if you are allergic to clotrimazole or betamethasone;||
6179|097|P|or to other azole antifungals (such as ketoconazole) or||
6179|098|P|corticosteroids (such as triamcinolone); or if you have any other||
6179|099|P|allergies. This product may contain inactive ingredients, which||
6179|100|P|can cause allergic reactions or other problems. Talk to your||
6179|101|P|pharmacist for more details.||
6179|102|P|   Before using this medication, tell your doctor or pharmacist||
6179|103|P|your medical history, especially of: immune system problems, poor||
6179|104|P|blood circulation.||
6179|105|P|   Rarely, using corticosteroid medications for a long time or||
6179|106|P|over large areas of skin can make it more difficult for your body||
6179|107|P|to respond to physical stress. Before having surgery or emergency||
6179|108|P|treatment, or if you get a serious illness/injury, tell your||
6179|109|P|doctor or dentist that you are using this medication or have used||
6179|110|P|this medication within the past few months.||
6179|111|P|   Though it is unlikely, this medication may temporarily slow||
6179|112|P|down a child's growth if used for a long time. See the doctor||
6179|113|P|regularly so your child's height can be checked.||
6179|114|P|   Older adults may be more sensitive to the side effects of this||
6179|115|P|drug, especially thinning skin.||
6179|116|P|   During pregnancy, this medication should be used only when||
6179|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
6179|118|P|   It is unknown if this medication passes into breast milk.||
6179|119|P|Similar medications pass into breast milk. Consult your doctor||
6179|120|P|before breastfeeding.||
6179|121|B|||
6179|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6179|123|I|medications work or increase your risk for serious side effects.||
6179|124|I|This document does not contain all possible drug interactions.||
6179|125|I|Keep a list of all the products you use (such as||
6179|126|I|prescription/nonprescription drugs and herbal products) and share||
6179|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
6179|128|I|the dosage of any medicines without your doctor's approval.||
6179|129|B|||
6179|130|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6179|131|O|has overdosed and has serious symptoms such as passing out or||
6179|132|O|trouble breathing, call 911. Otherwise, call a poison control||
6179|133|O|center right away. US residents can call 1-800-222-1222. Canada||
6179|134|O|residents can call 1-844-764-7669.||
6179|135|B|||
6179|136|N|NOTES:  Do not share this medication with others.||
6179|137|N|   Lab and/or medical tests (such as adrenal gland function) may||
6179|138|N|be done while you are using this medication, especially if you||
6179|139|N|use this drug for an extended period of time or apply it over||
6179|140|N|large areas of the body. Keep all medical and lab appointments.||
6179|141|N|Consult your doctor for more details.||
6179|142|N|   This medication has been prescribed for your current condition||
6179|143|N|only. Do not use it later for another infection unless your||
6179|144|N|doctor tells you to.||
6179|145|B|||
6179|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6179|147|D|If it is near the time of the next dose, skip the missed dose.||
6179|148|D|Use your next dose at the regular time. Do not double the dose to||
6179|149|D|catch up.||
6179|150|B|||
6179|151|R|STORAGE:  Store at room temperature. Keep all medications away||
6179|152|R|from children and pets.||
6179|153|R|   Do not flush medications down the toilet or pour them into a||
6179|154|R|drain unless instructed to do so. Properly discard this product||
6179|155|R|when it is expired or no longer needed. Consult your pharmacist||
6179|156|R|or local waste disposal company.||
6179|157|B|||
6179|158|A|Information last revised November 2024.||
6179|159|A|Copyright(c) 2025 First Databank, Inc.||
6179|160|B|||
6181|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6181|002|Z|does NOT have all possible information about this product. This||
6181|003|Z|information does not assure that this product is safe, effective,||
6181|004|Z|or appropriate for you. This information is not individual||
6181|005|Z|medical advice and does not substitute for the advice of your||
6181|006|Z|health care professional. Always ask your health care||
6181|007|Z|professional for complete information about this product and your||
6181|008|Z|specific health needs.||
6181|009|B|||
6181|010|T|ERYTHROMYCIN SOLUTION, LOTION - TOPICAL||
6181|011|F|(e-RITH-roe-MYE-sin)||
6181|012|B|||
6181|013|C|COMMON BRAND NAME(S): A/T/S||
6181|014|B|||
6181|015|U|USES:  This medication is used to treat acne. It helps to reduce||
6181|016|U|the number of pimples. Erythromycin is an antibiotic||
6181|017|U|(macrolide-type). It works by stopping the growth of bacteria.||
6181|018|U|Some brands of this product contain a large amount of alcohol,||
6181|019|U|which dries extra oils from the skin.||
6181|020|B|||
6181|021|H|HOW TO USE:  This medication is for use on the skin only. Clean||
6181|022|H|and dry the affected area as directed. Then apply a thin layer of||
6181|023|H|the medication on the skin using the applicator or cotton||
6181|024|H|balls/pads as directed by your doctor, usually twice a day. Wash||
6181|025|H|your hands after use.||
6181|026|H|   Do not use large amounts or apply this more often or for a||
6181|027|H|longer period than directed. Your condition will not clear||
6181|028|H|faster, but the risk of side effects may be increased.||
6181|029|H|   Use this medication regularly in order to get the most benefit||
6181|030|H|from it. Remember to use it at the same times each day.||
6181|031|H|   Avoid getting this medication in your eyes or inside the nose||
6181|032|H|or mouth. If this occurs, rinse thoroughly with water.||
6181|033|H|   Tell your doctor if your condition does not get better or if||
6181|034|H|it gets worse. It may take up to 3 months of regular use before||
6181|035|H|the full benefits of this medication take effect.||
6181|036|B|||
6181|037|S|SIDE EFFECTS:  Burning, redness, itching, or dry/peeling/oily||
6181|038|S|skin may occur, especially in the first few days as your body||
6181|039|S|adjusts to the medication. Eye irritation may also occur. If any||
6181|040|S|of these effects last or get worse, tell your doctor or||
6181|041|S|pharmacist promptly.||
6181|042|S|   Remember that this medication has been prescribed because your||
6181|043|S|doctor has judged that the benefit to you is greater than the||
6181|044|S|risk of side effects. Many people using this medication do not||
6181|045|S|have serious side effects.||
6181|046|S|   Rarely, use of this medication may result in other types of||
6181|047|S|skin infections (fungal or other bacterial infections). Contact||
6181|048|S|your doctor if you notice any unusual skin irritation or other||
6181|049|S|symptoms.||
6181|050|S|   A very serious allergic reaction to this drug is rare.||
6181|051|S|However, get medical help right away if you notice any symptoms||
6181|052|S|of a serious allergic reaction, including: rash, itching/swelling||
6181|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6181|054|S|breathing.||
6181|055|S|   This is not a complete list of possible side effects. If you||
6181|056|S|notice other effects not listed above, contact your doctor or||
6181|057|S|pharmacist.||
6181|058|S|   In the US -||
6181|059|S|   Call your doctor for medical advice about side effects. You||
6181|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6181|061|S|www.fda.gov/medwatch.||
6181|062|S|   In Canada - Call your doctor for medical advice about side||
6181|063|S|effects. You may report side effects to Health Canada at||
6181|064|S|1-866-234-2345.||
6181|065|B|||
6181|066|P|PRECAUTIONS:  Before using erythromycin, tell your doctor or||
6181|067|P|pharmacist if you are allergic to it; or to other antibiotics||
6181|068|P|(such as azithromycin, clarithromycin); or if you have any other||
6181|069|P|allergies. This product may contain inactive ingredients, which||
6181|070|P|can cause allergic reactions or other problems. Talk to your||
6181|071|P|pharmacist for more details.||
6181|072|P|   Before using this medication, tell your doctor or pharmacist||
6181|073|P|your medical history.||
6181|074|P|   During pregnancy, this medication should be used only when||
6181|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
6181|076|P|   It is unknown if this medication passes into breast milk.||
6181|077|P|Consult your doctor before breastfeeding.||
6181|078|B|||
6181|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6181|080|I|medications work or increase your risk for serious side effects.||
6181|081|I|This document does not contain all possible drug interactions.||
6181|082|I|Keep a list of all the products you use (including||
6181|083|I|prescription/nonprescription drugs and herbal products) and share||
6181|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
6181|085|I|the dosage of any medicines without your doctor's approval.||
6181|086|I|   A product that may interact with this drug is: disulfiram.||
6181|087|B|||
6181|088|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6181|089|O|has overdosed and has serious symptoms such as passing out or||
6181|090|O|trouble breathing, call 911. Otherwise, call a poison control||
6181|091|O|center right away. US residents can call 1-800-222-1222. Canada||
6181|092|O|residents can call 1-844-764-7669.||
6181|093|B|||
6181|094|N|NOTES:  Do not share this medication with others.||
6181|095|N|   For the best results, this medication is often used as part of||
6181|096|N|a total skin care program. Follow your doctor's recommendations.||
6181|097|B|||
6181|098|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6181|099|D|If it is near the time of the next dose, skip the missed dose.||
6181|100|D|Use your next dose at the regular time. Do not double the dose to||
6181|101|D|catch up.||
6181|102|B|||
6181|103|R|STORAGE:  Store at room temperature. This medication is||
6181|104|R|flammable. Keep it away from heat and open flame. Keep all||
6181|105|R|medications away from children and pets.||
6181|106|R|   Do not flush medications down the toilet or pour them into a||
6181|107|R|drain unless instructed to do so. Properly discard this product||
6181|108|R|when it is expired or no longer needed. Consult your pharmacist||
6181|109|R|or local waste disposal company.||
6181|110|B|||
6181|111|A|Information last revised July 2025.||
6181|112|A|Copyright(c) 2025 First Databank, Inc.||
6181|113|B|||
6186|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6186|002|Z|does NOT have all possible information about this product. This||
6186|003|Z|information does not assure that this product is safe, effective,||
6186|004|Z|or appropriate for you. This information is not individual||
6186|005|Z|medical advice and does not substitute for the advice of your||
6186|006|Z|health care professional. Always ask your health care||
6186|007|Z|professional for complete information about this product and your||
6186|008|Z|specific health needs.||
6186|009|B|||
6186|010|T|DICLOFENAC - ORAL||
6186|011|F|(dye-KLOE-fen-ak)||
6186|012|B|||
6186|013|C|COMMON BRAND NAME(S): Cataflam, Zipsor||
6186|014|B|||
6186|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
6186|016|W|diclofenac) may rarely increase the risk of a heart attack or||
6186|017|W|stroke. This effect can happen at any time while taking this drug||
6186|018|W|but is more likely if you take it for a long time. The risk may||
6186|019|W|be greater in older adults or if you have heart disease or||
6186|020|W|increased risk for heart disease (for example, due to smoking,||
6186|021|W|family history of heart disease, or conditions such as high blood||
6186|022|W|pressure or diabetes). Do not take this drug right before or||
6186|023|W|after heart bypass surgery (CABG).||
6186|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
6186|025|W|bleeding from the stomach or intestines. This effect can occur||
6186|026|W|without warning symptoms at any time while taking this drug.||
6186|027|W|Older adults may be at higher risk for this effect.||
6186|028|W|   Stop taking diclofenac and get medical help right away if you||
6186|029|W|notice any of these rare but serious side effects:||
6186|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
6186|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
6186|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
6186|033|W|side of the body, trouble speaking, sudden vision changes.||
6186|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
6186|035|W|of taking this drug.||
6186|036|B|||
6186|037|U|USES:  See also Warning section.||
6186|038|U|   Diclofenac is used to relieve mild to moderate pain and||
6186|039|U|swelling (inflammation) from various conditions such as headache,||
6186|040|U|dental pain, menstrual cramps, and muscle aches. Some brands of||
6186|041|U|this medication may also reduce pain, swelling, and joint||
6186|042|U|stiffness from arthritis. Reducing these symptoms helps you do||
6186|043|U|more of your normal daily activities.||
6186|044|U|   Diclofenac is known as a nonsteroidal anti-inflammatory drug||
6186|045|U|(NSAID). It works by blocking your body's production of certain||
6186|046|U|natural substances that cause inflammation. This effect helps to||
6186|047|U|decrease swelling, pain, or fever.||
6186|048|U|   If you are treating a chronic condition such as arthritis, ask||
6186|049|U|your doctor about non-drug treatments and/or using other||
6186|050|U|medications to treat your pain.||
6186|051|B|||
6186|052|V|OTHER USES:  This section contains uses of this drug that are not||
6186|053|V|listed in the approved professional labeling for the drug but||
6186|054|V|that may be prescribed by your health care professional. Use this||
6186|055|V|drug for a condition that is listed in this section only if it||
6186|056|V|has been so prescribed by your health care professional.||
6186|057|V|   This medication may also be used for gout attacks.||
6186|058|B|||
6186|059|H|HOW TO USE:  Read the Medication Guide provided by your||
6186|060|H|pharmacist before you start taking diclofenac and each time you||
6186|061|H|get a refill. If you have any questions, ask your doctor or||
6186|062|H|pharmacist.||
6186|063|H|   Take this medication by mouth as directed by your doctor,||
6186|064|H|usually 2-4 times a day. Take this medication with a full glass||
6186|065|H|of water (8 ounces/240 milliliters) unless your doctor directs||
6186|066|H|you otherwise. Do not lie down for at least 10 minutes after||
6186|067|H|taking this medication. If stomach upset occurs while taking this||
6186|068|H|medication, take it with food, milk, or an antacid.||
6186|069|H|   There are different brands and forms of this medication||
6186|070|H|available. Because different forms do not have the same effects||
6186|071|H|at equal strengths, do not switch forms of diclofenac unless your||
6186|072|H|doctor tells you to.||
6186|073|H|   The dosage is based on your medical condition, response to||
6186|074|H|treatment, and other medications you may be taking. To reduce||
6186|075|H|your risk of stomach bleeding and other side effects, take this||
6186|076|H|medication at the lowest effective dose for the shortest possible||
6186|077|H|time. Do not increase your dose or take this drug more often or||
6186|078|H|for longer than prescribed. Discuss the risks and benefits with||
6186|079|H|your doctor or pharmacist.||
6186|080|H|   For certain conditions (such as arthritis), it may take up to||
6186|081|H|2 weeks of taking this drug regularly until you get the full||
6186|082|H|benefit.||
6186|083|H|   If you are taking this drug "as needed" (not on a regular||
6186|084|H|schedule), remember that pain medications work best if they are||
6186|085|H|used as the first signs of pain occur. If you wait until the pain||
6186|086|H|has worsened, the medicine may not work as well.||
6186|087|H|   Tell your doctor if your condition gets worse.||
6186|088|B|||
6186|089|S|SIDE EFFECTS:  See also Warning section.||
6186|090|S|   Upset stomach, nausea, heartburn, diarrhea, constipation, gas,||
6186|091|S|headache, drowsiness, dizziness, or blurred vision may occur. If||
6186|092|S|any of these effects last or get worse, tell your doctor or||
6186|093|S|pharmacist promptly.||
6186|094|S|   Remember that this medication has been prescribed because your||
6186|095|S|doctor has judged that the benefit to you is greater than the||
6186|096|S|risk of side effects. Many people using this medication do not||
6186|097|S|have serious side effects.||
6186|098|S|   This medication may raise your blood pressure. Check your||
6186|099|S|blood pressure regularly and tell your doctor if the results are||
6186|100|S|high.||
6186|101|S|   Tell your doctor right away if you have any serious side||
6186|102|S|effects, including: hearing changes (such as ringing in the||
6186|103|S|ears), mental/mood changes, easy bleeding/bruising,||
6186|104|S|difficult/painful swallowing, signs of kidney problems (such as||
6186|105|S|change in the amount of urine, pink/bloody urine), symptoms of||
6186|106|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
6186|107|S|unusual/sudden weight gain).||
6186|108|S|   Diclofenac may rarely cause serious (possibly fatal) liver||
6186|109|S|disease. Get medical help right away if you have any symptoms of||
6186|110|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
6186|111|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
6186|112|S|urine.||
6186|113|S|   A very serious allergic reaction to this drug is rare.||
6186|114|S|However, get medical help right away if you notice any symptoms||
6186|115|S|of a serious allergic reaction, including: fever, swollen lymph||
6186|116|S|nodes, rash, itching/swelling (especially of the||
6186|117|S|face/tongue/throat), severe dizziness, trouble breathing.||
6186|118|S|   This is not a complete list of possible side effects. If you||
6186|119|S|notice other effects not listed above, contact your doctor or||
6186|120|S|pharmacist.||
6186|121|S|   In the US -||
6186|122|S|   Call your doctor for medical advice about side effects. You||
6186|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6186|124|S|www.fda.gov/medwatch.||
6186|125|S|   In Canada - Call your doctor for medical advice about side||
6186|126|S|effects. You may report side effects to Health Canada at||
6186|127|S|1-866-234-2345.||
6186|128|B|||
6186|129|P|PRECAUTIONS:  See also Warning section.||
6186|130|P|   Before taking diclofenac, tell your doctor or pharmacist if||
6186|131|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
6186|132|P|ibuprofen, naproxen, celecoxib); or if you have any other||
6186|133|P|allergies. This product may contain inactive ingredients, which||
6186|134|P|can cause allergic reactions or other problems. Talk to your||
6186|135|P|pharmacist for more details.||
6186|136|P|   Before using this medication, tell your doctor or pharmacist||
6186|137|P|your medical history, especially of: asthma (including a history||
6186|138|P|of worsening breathing after taking aspirin or other NSAIDs),||
6186|139|P|blood disorders (such as anemia, bleeding/clotting problems),||
6186|140|P|growths in the nose (nasal polyps), heart disease (such as||
6186|141|P|previous heart attack), high blood pressure, liver disease,||
6186|142|P|stroke, swelling (edema, fluid retention),||
6186|143|P|stomach/intestinal/esophagus problems (such as bleeding,||
6186|144|P|heartburn, ulcers).||
6186|145|P|   Kidney problems can sometimes occur with the use of NSAID||
6186|146|P|medications, including diclofenac. Problems are more likely to||
6186|147|P|occur if you are dehydrated, have heart failure or kidney||
6186|148|P|disease, are an older adult, or if you take certain medications||
6186|149|P|(see also Drug Interactions section). Drink plenty of fluids as||
6186|150|P|directed by your doctor to prevent dehydration and tell your||
6186|151|P|doctor right away if you have pink/bloody urine or any unusual||
6186|152|P|change in the amount of urine.||
6186|153|P|   This drug may make you dizzy or drowsy or cause blurred||
6186|154|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
6186|155|P|Do not drive, use machinery, or do anything that needs alertness||
6186|156|P|or clear vision until you can do it safely. Limit alcoholic||
6186|157|P|beverages. Talk to your doctor if you are using marijuana||
6186|158|P|(cannabis).||
6186|159|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
6186|160|P|and tobacco, especially when combined with this medicine, may||
6186|161|P|increase your risk for stomach bleeding. Limit alcohol and stop||
6186|162|P|smoking.||
6186|163|P|   This medication may make you more sensitive to the sun. Limit||
6186|164|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
6186|165|P|sunscreen and wear protective clothing when outdoors. Tell your||
6186|166|P|doctor right away if you get sunburned or have skin||
6186|167|P|blisters/redness.||
6186|168|P|   Before having surgery, tell your doctor or dentist about all||
6186|169|P|the products you use (including prescription drugs,||
6186|170|P|nonprescription drugs, and herbal products).||
6186|171|P|   Older adults may be at greater risk for stomach/intestinal||
6186|172|P|bleeding, kidney problems, heart attack, and stroke while using||
6186|173|P|this drug.||
6186|174|P|   Before using this medication, women of childbearing age should||
6186|175|P|talk with their doctor(s) about the benefits and risks. Tell your||
6186|176|P|doctor if you are pregnant or if you plan to become pregnant.||
6186|177|P|This medication may harm an unborn baby and cause problems with||
6186|178|P|normal labor/delivery. It is not recommended for use in pregnancy||
6186|179|P|from 20 weeks until delivery. If your doctor decides that you||
6186|180|P|need to use this medication between 20 and 30 weeks of pregnancy,||
6186|181|P|you should use the lowest effective dose for the shortest||
6186|182|P|possible time. You should not use this medication after 30 weeks||
6186|183|P|of pregnancy.||
6186|184|P|   This medication passes into breast milk. Consult your doctor||
6186|185|P|before breastfeeding.||
6186|186|B|||
6186|187|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6186|188|I|medications work or increase your risk for serious side effects.||
6186|189|I|This document does not contain all possible drug interactions.||
6186|190|I|Keep a list of all the products you use (including||
6186|191|I|prescription/nonprescription drugs and herbal products) and share||
6186|192|I|it with your doctor and pharmacist. Do not start, stop, or change||
6186|193|I|the dosage of any medicines without your doctor's approval.||
6186|194|I|   Some products that may interact with this drug are: aliskiren,||
6186|195|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
6186|196|I|receptor blockers (such as losartan, valsartan), cidofovir,||
6186|197|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
6186|198|I|methotrexate, "water pills" (diuretics such as furosemide).||
6186|199|I|   This medication may increase the risk of bleeding when taken||
6186|200|I|with other drugs that also may cause bleeding. Examples include||
6186|201|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
6186|202|I|dabigatran/enoxaparin/warfarin, among others.||
6186|203|I|   Check all prescription and nonprescription medicine labels||
6186|204|I|carefully since many medications contain pain relievers/fever||
6186|205|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
6186|206|I|naproxen). These drugs are similar to diclofenac and may increase||
6186|207|I|your risk of side effects if taken together. However, if your||
6186|208|I|doctor has told you to take low-dose aspirin to prevent heart||
6186|209|I|attack or stroke (usually 81-162 milligrams a day), you should||
6186|210|I|keep taking the aspirin unless your doctor tells you not to. Ask||
6186|211|I|your doctor or pharmacist for more details.||
6186|212|B|||
6186|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6186|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6186|215|O|poison control center right away. US residents can call||
6186|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6186|217|O|Symptoms of overdose may include: severe stomach pain,||
6186|218|O|slow/shallow breathing, extreme drowsiness.||
6186|219|B|||
6186|220|N|NOTES:  Do not share this medication with others.||
6186|221|N|   Lab and/or medical tests (such as complete blood count,||
6186|222|N|liver/kidney function, blood pressure) may be done while you are||
6186|223|N|using this medication. Keep all medical and lab appointments.||
6186|224|N|Consult your doctor for more details.||
6186|225|N|   Lifestyle changes (such as weight loss if needed,||
6186|226|N|strengthening/conditioning exercises) may help improve your||
6186|227|N|flexibility and joint function. Consult your doctor for specific||
6186|228|N|instructions.||
6186|229|B|||
6186|230|D|MISSED DOSE:  If you are prescribed this drug on a regular||
6186|231|D|schedule (not just "as needed") and you miss a dose, take it as||
6186|232|D|soon as you remember. If it is near the time of the next dose,||
6186|233|D|skip the missed dose. Take your next dose at the regular time. Do||
6186|234|D|not double the dose to catch up.||
6186|235|B|||
6186|236|R|STORAGE:  Store at room temperature away from light and moisture.||
6186|237|R|Do not store in the bathroom. Keep all medications away from||
6186|238|R|children and pets.||
6186|239|R|   Do not flush medications down the toilet or pour them into a||
6186|240|R|drain unless instructed to do so. Properly discard this product||
6186|241|R|when it is expired or no longer needed. Consult your pharmacist||
6186|242|R|or local waste disposal company.||
6186|243|B|||
6186|244|A|Information last revised September 2024.||
6186|245|A|Copyright(c) 2025 First Databank, Inc.||
6186|246|B|||
6193|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6193|002|Z|does NOT have all possible information about this product. This||
6193|003|Z|information does not assure that this product is safe, effective,||
6193|004|Z|or appropriate for you. This information is not individual||
6193|005|Z|medical advice and does not substitute for the advice of your||
6193|006|Z|health care professional. Always ask your health care||
6193|007|Z|professional for complete information about this product and your||
6193|008|Z|specific health needs.||
6193|009|B|||
6193|010|T|PODOFILOX GEL - TOPICAL||
6193|011|F|(poe-DOF-il-ox)||
6193|012|B|||
6193|013|C|COMMON BRAND NAME(S): Condylox||
6193|014|B|||
6193|015|U|USES:  This medication is used on the skin to treat external||
6193|016|U|genital warts.||
6193|017|B|||
6193|018|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6193|019|H|from your pharmacist before you start using podofilox gel and||
6193|020|H|each time you get a refill. If you have any questions, ask your||
6193|021|H|doctor or pharmacist.||
6193|022|H|   This medication is for use on the skin only. Apply it on the||
6193|023|H|warts pointed out by your doctor. It is usually applied once in||
6193|024|H|the morning and again in the evening for 3 days followed by a 4||
6193|025|H|day rest period. If the warts do not go away, then this cycle is||
6193|026|H|repeated up to 4 times. Contact your doctor for other options if||
6193|027|H|the warts do not go away after 4 weeks of treatment.||
6193|028|H|   To apply, use the provided applicator tip or your finger.||
6193|029|H|Apply a small amount of medication to the wart to cover it. Allow||
6193|030|H|the gel to dry. Wash your hands thoroughly afterwards. Be careful||
6193|031|H|with this medication because it can irritate normal skin around||
6193|032|H|the application site.||
6193|033|H|   Do not use large amounts, apply more often or use for a longer||
6193|034|H|period than directed. Your condition will not clear faster, and||
6193|035|H|the chance for side effects may be increased.||
6193|036|H|   Avoid contact with the eyes and mucous membranes. If contact||
6193|037|H|occurs, immediately wash with plenty of water and contact your||
6193|038|H|doctor.||
6193|039|B|||
6193|040|S|SIDE EFFECTS:  Swelling, pain, burning, itching, peeling skin,||
6193|041|S|small sores, or headache may occur. If any of these effects last||
6193|042|S|or get worse, tell your doctor or pharmacist promptly.||
6193|043|S|   Remember that this medication has been prescribed because your||
6193|044|S|doctor has judged that the benefit to you is greater than the||
6193|045|S|risk of side effects. Many people using this medication do not||
6193|046|S|have serious side effects.||
6193|047|S|   Tell your doctor right away if you have any serious side||
6193|048|S|effects, including: bleeding.||
6193|049|S|   A very serious allergic reaction to this drug is rare.||
6193|050|S|However, get medical help right away if you notice any symptoms||
6193|051|S|of a serious allergic reaction, including: rash, itching/swelling||
6193|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6193|053|S|breathing.||
6193|054|S|   This is not a complete list of possible side effects. If you||
6193|055|S|notice other effects not listed above, contact your doctor or||
6193|056|S|pharmacist.||
6193|057|S|   In the US -||
6193|058|S|   Call your doctor for medical advice about side effects. You||
6193|059|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6193|060|S|www.fda.gov/medwatch.||
6193|061|S|   In Canada - Call your doctor for medical advice about side||
6193|062|S|effects. You may report side effects to Health Canada at||
6193|063|S|1-866-234-2345.||
6193|064|B|||
6193|065|P|PRECAUTIONS:  Before using podofilox, tell your doctor or||
6193|066|P|pharmacist if you are allergic to it; or if you have any other||
6193|067|P|allergies. This product may contain inactive ingredients, which||
6193|068|P|can cause allergic reactions or other problems. Talk to your||
6193|069|P|pharmacist for more details.||
6193|070|P|   Before using this medication, tell your doctor or pharmacist||
6193|071|P|your medical history.||
6193|072|P|   This medication is not a cure for genital warts. These warts||
6193|073|P|are caused by a virus called human papillomavirus (HPV).||
6193|074|P|Podofilox does not destroy the virus. It only helps to remove the||
6193|075|P|warts, but new warts may form or old warts may return, during and||
6193|076|P|after treatment.||
6193|077|P|   Do not have sexual intercourse on the days you have applied||
6193|078|P|this medication.||
6193|079|P|   Genital warts are spread by sexual contact. Condoms (such as||
6193|080|P|latex or polyurethane types) may help prevent the spread of||
6193|081|P|genital warts to your partner. Consult your doctor or pharmacist||
6193|082|P|for more details.||
6193|083|P|   This medication must not be used during pregnancy. It may harm||
6193|084|P|an unborn baby. Discuss the use of reliable forms of birth||
6193|085|P|control with your doctor. If you become pregnant or think you may||
6193|086|P|be pregnant, tell your doctor right away.||
6193|087|P|   It is unknown if this drug passes into breast milk. Consult||
6193|088|P|your doctor before breastfeeding.||
6193|089|B|||
6193|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6193|091|I|medications work or increase your risk for serious side effects.||
6193|092|I|This document does not contain all possible drug interactions.||
6193|093|I|Keep a list of all the products you use (including||
6193|094|I|prescription/nonprescription drugs and herbal products) and share||
6193|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
6193|096|I|the dosage of any medicines without your doctor's approval.||
6193|097|B|||
6193|098|O|OVERDOSE:  This medicine may be harmful if swallowed. If too much||
6193|099|O|of this medication is applied to the skin, wash it off with||
6193|100|O|plenty of soap and water. If someone has overdosed and has||
6193|101|O|serious symptoms such as passing out or trouble breathing, call||
6193|102|O|911. Otherwise, call a poison control center right away. US||
6193|103|O|residents can call 1-800-222-1222. Canada residents can call||
6193|104|O|1-844-764-7669. Symptoms of overdose may include: nausea,||
6193|105|O|vomiting, diarrhea, trouble breathing, seizures.||
6193|106|B|||
6193|107|N|NOTES:  Do not share this medication with others.||
6193|108|N|   This medication is prescribed for your current condition only.||
6193|109|N|Do not use it later for another skin problem unless directed by||
6193|110|N|your doctor. A different medication may be necessary in those||
6193|111|N|cases.||
6193|112|B|||
6193|113|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
6193|114|D|remember. If it is near the time of the next dose, skip the||
6193|115|D|missed dose. Use your next dose at the regular time. Do not||
6193|116|D|double the dose to catch up.||
6193|117|B|||
6193|118|R|STORAGE:  Store at room temperature away from heat or open flame.||
6193|119|R|Do not freeze. Keep all medications away from children and pets.||
6193|120|R|   Do not flush medications down the toilet or pour them into a||
6193|121|R|drain unless instructed to do so. Properly discard this product||
6193|122|R|when it is expired or no longer needed. Consult your pharmacist||
6193|123|R|or local waste disposal company.||
6193|124|B|||
6193|125|A|Information last revised May 2024.||
6193|126|A|Copyright(c) 2025 First Databank, Inc.||
6193|127|B|||
6196|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6196|002|Z|does NOT have all possible information about this product. This||
6196|003|Z|information does not assure that this product is safe, effective,||
6196|004|Z|or appropriate for you. This information is not individual||
6196|005|Z|medical advice and does not substitute for the advice of your||
6196|006|Z|health care professional. Always ask your health care||
6196|007|Z|professional for complete information about this product and your||
6196|008|Z|specific health needs.||
6196|009|B|||
6196|010|T|OFLOXACIN SOLUTION - OTIC||
6196|011|F|(oh-FLOX-a-sin)||
6196|012|B|||
6196|013|C|COMMON BRAND NAME(S): Floxin||
6196|014|B|||
6196|015|U|USES:  Ofloxacin is used to treat outer ear infections (swimmer's||
6196|016|U|ear or ear canal infections) and middle ear infections. It works||
6196|017|U|by stopping the growth of bacteria. This medication belongs to a||
6196|018|U|class of drugs called quinolone antibiotics.||
6196|019|U|   This medication treats only bacterial ear infections. It will||
6196|020|U|not work for other types of ear infections. Unnecessary use or||
6196|021|U|overuse of any antibiotic can lead to its decreased||
6196|022|U|effectiveness.||
6196|023|B|||
6196|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6196|025|H|from your pharmacist before you start using ofloxacin and each||
6196|026|H|time you get a refill. If you have any questions, ask your doctor||
6196|027|H|or pharmacist.||
6196|028|H|   To make sure that the right amount of medication is given, and||
6196|029|H|to avoid touching the ear with the dropper, have another person||
6196|030|H|give the drops if possible. To lower the risk of dizziness, hold||
6196|031|H|the container in your hand for a few minutes in order to warm it.||
6196|032|H|   To apply ear drops, wash your hands first. To avoid||
6196|033|H|contamination, do not touch the dropper tip or let it touch your||
6196|034|H|ear or any other surface.||
6196|035|H|   Lie on your side or tilt the affected ear upward. Hold the||
6196|036|H|dropper directly over the ear, and place the prescribed number of||
6196|037|H|drops into the ear canal. If you are using the single-use||
6196|038|H|containers, empty the contents of the prescribed number of||
6196|039|H|containers into your ear. For outer ear infections, to help the||
6196|040|H|drops roll into the ear, adults should hold the earlobe up and||
6196|041|H|back. In children, hold the earlobe down and back. For middle ear||
6196|042|H|infections, gently press down several times on the cartilage that||
6196|043|H|partially covers your ear opening to allow the drops to enter||
6196|044|H|your middle ear (see Patient Information Leaflet).||
6196|045|H|   Keep your head tilted for about 5 minutes, or insert a soft||
6196|046|H|cotton plug if so directed. Repeat the above steps for your other||
6196|047|H|ear if so directed.||
6196|048|H|   Do not rinse the dropper. Replace the dropper cap on the||
6196|049|H|bottle after each use. If you are using the single-dose||
6196|050|H|containers, discard any unused solution after each application.||
6196|051|H|Do not reuse.||
6196|052|H|   Use this medication regularly to get the most benefit from it.||
6196|053|H|To help you remember, use it at the same time(s) each day.||
6196|054|H|Continue to use this medication for the full time prescribed,||
6196|055|H|even if symptoms disappear after a few days. Stopping the||
6196|056|H|medication too early may result in a return of the infection.||
6196|057|H|   Tell your doctor if your condition does not get better in 1||
6196|058|H|week. Report any ear discharge that occurs after the treatment||
6196|059|H|period is completed.||
6196|060|H|   Do not use in the eye.||
6196|061|B|||
6196|062|S|SIDE EFFECTS:  Mild irritation/discomfort in the ear, dizziness,||
6196|063|S|headache, earache, or changes in taste may occur. If any of these||
6196|064|S|effects last or get worse, tell your doctor or pharmacist||
6196|065|S|promptly.||
6196|066|S|   Remember that this medication has been prescribed because your||
6196|067|S|doctor has judged that the benefit to you is greater than the||
6196|068|S|risk of side effects. Many people using this medication do not||
6196|069|S|have serious side effects.||
6196|070|S|   Tell your doctor right away if you have any serious side||
6196|071|S|effects, including: tingling/numbness, hearing changes.||
6196|072|S|   Use of this medication for prolonged or repeated periods may||
6196|073|S|result in a new fungal ear infection. Do not use it for longer||
6196|074|S|than prescribed. Contact your doctor if you notice new or||
6196|075|S|worsening symptoms.||
6196|076|S|   A very serious allergic reaction to this drug is rare.||
6196|077|S|However, get medical help right away if you notice any symptoms||
6196|078|S|of a serious allergic reaction, including: rash, itching/swelling||
6196|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6196|080|S|breathing.||
6196|081|S|   This is not a complete list of possible side effects. If you||
6196|082|S|notice other effects not listed above, contact your doctor or||
6196|083|S|pharmacist.||
6196|084|S|   In the US -||
6196|085|S|   Call your doctor for medical advice about side effects. You||
6196|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6196|087|S|www.fda.gov/medwatch.||
6196|088|S|   In Canada - Call your doctor for medical advice about side||
6196|089|S|effects. You may report side effects to Health Canada at||
6196|090|S|1-866-234-2345.||
6196|091|B|||
6196|092|P|PRECAUTIONS:  Before using ofloxacin, tell your doctor or||
6196|093|P|pharmacist if you are allergic to it; or to other quinolone||
6196|094|P|antibiotics (such as ciprofloxacin, levofloxacin); or if you have||
6196|095|P|any other allergies. This product may contain inactive||
6196|096|P|ingredients (such as preservatives like benzalkonium chloride),||
6196|097|P|which can cause allergic reactions or other problems. Talk to||
6196|098|P|your pharmacist for more details.||
6196|099|P|   Before using this medication, tell your doctor or pharmacist||
6196|100|P|your medical history, especially of: other ear problems, two or||
6196|101|P|more ear infections within 6 months.||
6196|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6196|103|P|can make you more dizzy. Do not drive, use machinery, or do||
6196|104|P|anything that needs alertness until you can do it safely. Limit||
6196|105|P|alcoholic beverages. Talk to your doctor if you are using||
6196|106|P|marijuana (cannabis).||
6196|107|P|   During pregnancy, this medication should be used only when||
6196|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
6196|109|P|   It is unknown if this medication passes into breast milk.||
6196|110|P|However, it is unlikely to harm a nursing infant. Consult your||
6196|111|P|doctor before breastfeeding.||
6196|112|B|||
6196|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6196|114|I|medications work or increase your risk for serious side effects.||
6196|115|I|This document does not contain all possible drug interactions.||
6196|116|I|Keep a list of all the products you use (including||
6196|117|I|prescription/nonprescription drugs and herbal products) and share||
6196|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
6196|119|I|the dosage of any medicines without your doctor's approval.||
6196|120|B|||
6196|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6196|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6196|123|O|poison control center right away. US residents can call||
6196|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
6196|125|O|medicine may be harmful if swallowed.||
6196|126|B|||
6196|127|N|NOTES:  Do not share this medication with others.||
6196|128|N|   This medication has been prescribed for your current condition||
6196|129|N|only. Do not use it later for another infection unless your||
6196|130|N|doctor tells you to.||
6196|131|N|   It is important to keep the infected ear(s) clean and dry. Try||
6196|132|N|not to get the infected ear(s) wet when bathing. Avoid swimming||
6196|133|N|unless your doctor tells you otherwise.||
6196|134|B|||
6196|135|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6196|136|D|If it is near the time of the next dose, skip the missed dose.||
6196|137|D|Use your next dose at the regular time. Do not double the dose to||
6196|138|D|catch up.||
6196|139|B|||
6196|140|R|STORAGE:  Store at room temperature away from light. Keep all||
6196|141|R|medications away from children and pets.||
6196|142|R|   Do not flush medications down the toilet or pour them into a||
6196|143|R|drain unless instructed to do so. Properly discard this product||
6196|144|R|when it is expired or no longer needed. Consult your pharmacist||
6196|145|R|or local waste disposal company.||
6196|146|B|||
6196|147|A|Information last revised June 2025.||
6196|148|A|Copyright(c) 2025 First Databank, Inc.||
6196|149|B|||
6202|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6202|002|Z|does NOT have all possible information about this product. This||
6202|003|Z|information does not assure that this product is safe, effective,||
6202|004|Z|or appropriate for you. This information is not individual||
6202|005|Z|medical advice and does not substitute for the advice of your||
6202|006|Z|health care professional. Always ask your health care||
6202|007|Z|professional for complete information about this product and your||
6202|008|Z|specific health needs.||
6202|009|B|||
6202|010|T|GLYCERIN SUPPOSITORY - RECTAL||
6202|011|F|(GLIS-er-in)||
6202|012|B|||
6202|013|C|COMMON BRAND NAME(S): Sani-Supp||
6202|014|B|||
6202|015|U|USES:  This product is used to relieve occasional constipation.||
6202|016|U|Glycerin belongs to a class of drugs known as hyperosmotic||
6202|017|U|laxatives. It works by drawing water into the intestines. This||
6202|018|U|effect usually results in a bowel movement within 15 to 60||
6202|019|U|minutes.||
6202|020|U|   For adults, the normal frequency of bowel movements varies||
6202|021|U|from once daily to 1 to 2 times weekly. For preschool-aged||
6202|022|U|children, the normal frequency of bowel movements varies from||
6202|023|U|once daily to once every other day. Constipation is best treated||
6202|024|U|by drinking plenty of fluids, eating foods high in fiber, and||
6202|025|U|exercising regularly.||
6202|026|B|||
6202|027|H|HOW TO USE:  This product is for rectal use only. Read and follow||
6202|028|H|all directions on the product package, or use as directed by your||
6202|029|H|doctor. If you have any questions, ask your doctor or pharmacist.||
6202|030|H|If the suppository is too soft to insert, chill in the||
6202|031|H|refrigerator for 30 minutes or run cold water over it before||
6202|032|H|removing the foil wrapper.||
6202|033|H|   Wash your hands before and after using this product. If the||
6202|034|H|medication is wrapped in foil, remove the foil wrapper. If||
6202|035|H|desired, the suppository may be moistened with lukewarm water. Do||
6202|036|H|not use petroleum jelly or mineral oil. Doing so may cause the||
6202|037|H|product to be less effective.||
6202|038|H|   Lie on your left side with the right knee slightly bent. Using||
6202|039|H|your finger, gently insert the suppository well up into the||
6202|040|H|rectum, pointed end first. After insertion, stay in position for||
6202|041|H|15 to 20 minutes if possible until you feel a strong urge to have||
6202|042|H|a bowel movement. This product does not need to melt completely||
6202|043|H|to produce an effect. If you are helping a child use this||
6202|044|H|product, have the child lie on their side with the lower leg||
6202|045|H|straightened out and the upper leg bent toward the stomach. Using||
6202|046|H|your finger, gently insert the suppository into the rectum,||
6202|047|H|pointed end first. Hold the buttocks together for a few seconds.||
6202|048|H|Then, have your child stay lying down for 15 to 20 minutes if||
6202|049|H|possible to keep the suppository from coming out.||
6202|050|H|   Do not use this product more than once daily unless otherwise||
6202|051|H|directed by your doctor.||
6202|052|H|   If this product is used too often, it may cause loss of normal||
6202|053|H|bowel function and an inability to have a bowel movement without||
6202|054|H|using the product (laxative dependence). If you notice symptoms||
6202|055|H|of overuse, such as diarrhea, abdominal pain, decreased weight,||
6202|056|H|or weakness, contact your doctor promptly.||
6202|057|H|   Consult your doctor promptly if you do not have a bowel||
6202|058|H|movement after using this product or if you think you may have a||
6202|059|H|serious medical problem.||
6202|060|B|||
6202|061|S|SIDE EFFECTS:  Rectal irritation/burning, abdominal||
6202|062|S|discomfort/cramps, or small amounts of mucus in the stool may||
6202|063|S|occur. If any of these effects last or get worse, tell your||
6202|064|S|doctor or pharmacist promptly.||
6202|065|S|   If your doctor has directed you to use this product, remember||
6202|066|S|that your doctor has judged that the benefit to you is greater||
6202|067|S|than the risk of side effects. Many people using this product do||
6202|068|S|not have serious side effects.||
6202|069|S|   Tell your doctor right away if you have any serious side||
6202|070|S|effects, including: abdominal pain that is severe or doesn't go||
6202|071|S|away, bloody stools, rectal bleeding.||
6202|072|S|   Diarrhea that doesn't stop may result in dehydration. Contact||
6202|073|S|your doctor promptly if you notice any symptoms of dehydration,||
6202|074|S|such as unusual decreased urination, unusual dry mouth/thirst,||
6202|075|S|fast heartbeat, or dizziness/lightheadedness.||
6202|076|S|   A very serious allergic reaction to this drug is rare.||
6202|077|S|However, get medical help right away if you notice any symptoms||
6202|078|S|of a serious allergic reaction, including: rash, itching/swelling||
6202|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6202|080|S|breathing.||
6202|081|S|   This is not a complete list of possible side effects. If you||
6202|082|S|notice other effects not listed above, contact your doctor or||
6202|083|S|pharmacist.||
6202|084|S|   In the US -||
6202|085|S|   Call your doctor for medical advice about side effects. You||
6202|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6202|087|S|www.fda.gov/medwatch.||
6202|088|S|   In Canada - Call your doctor for medical advice about side||
6202|089|S|effects. You may report side effects to Health Canada at||
6202|090|S|1-866-234-2345.||
6202|091|B|||
6202|092|P|PRECAUTIONS:  Before using glycerin, tell your doctor or||
6202|093|P|pharmacist if you are allergic to it; or if you have any other||
6202|094|P|allergies. This product may contain inactive ingredients, which||
6202|095|P|can cause allergic reactions or other problems. Talk to your||
6202|096|P|pharmacist for more details.||
6202|097|P|   Before using this medication, tell your doctor or pharmacist||
6202|098|P|your medical history, especially of: rectal bleeding, intestinal||
6202|099|P|blockage (obstruction), other bowel problems (such as ulcerative||
6202|100|P|colitis, hemorrhoids), current stomach/abdominal symptoms (such||
6202|101|P|as nausea/vomiting that doesn't stop, pain, cramping).||
6202|102|P|   Consult your doctor before using this product if you have had||
6202|103|P|a sudden change in bowel habits lasting more than 2 weeks or if||
6202|104|P|you need to use a laxative for more than 1 week. These could be||
6202|105|P|symptoms of a serious medical problem.||
6202|106|P|   During pregnancy, this medication should be used only when||
6202|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
6202|108|P|   It is unknown if this drug passes into breast milk. Consult||
6202|109|P|your doctor before breastfeeding.||
6202|110|B|||
6202|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6202|112|I|medications work or increase your risk for serious side effects.||
6202|113|I|This document does not contain all possible drug interactions.||
6202|114|I|Keep a list of all the products you use (including||
6202|115|I|prescription/nonprescription drugs and herbal products) and share||
6202|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
6202|117|I|the dosage of any medicines without your doctor's approval.||
6202|118|B|||
6202|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6202|120|O|has overdosed and has serious symptoms such as passing out or||
6202|121|O|trouble breathing, call 911. Otherwise, call a poison control||
6202|122|O|center right away. US residents can call 1-800-222-1222. Canada||
6202|123|O|residents can call 1-844-764-7669.||
6202|124|B|||
6202|125|N|NOTES:  Keep all medical and lab appointments.||
6202|126|B|||
6202|127|D|MISSED DOSE:  Not applicable.||
6202|128|B|||
6202|129|R|STORAGE:  Refer to storage information on the package label. If||
6202|130|R|you have any questions about storage, ask your pharmacist. Keep||
6202|131|R|all drug products away from children and pets.||
6202|132|R|   Do not flush medications down the toilet or pour them into a||
6202|133|R|drain unless instructed to do so. Properly discard this product||
6202|134|R|when it is expired or no longer needed. Consult your pharmacist||
6202|135|R|or local waste disposal company.||
6202|136|B|||
6202|137|A|Information last revised January 2025.||
6202|138|A|Copyright(c) 2025 First Databank, Inc.||
6202|139|B|||
6204|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6204|002|Z|does NOT have all possible information about this product. This||
6204|003|Z|information does not assure that this product is safe, effective,||
6204|004|Z|or appropriate for you. This information is not individual||
6204|005|Z|medical advice and does not substitute for the advice of your||
6204|006|Z|health care professional. Always ask your health care||
6204|007|Z|professional for complete information about this product and your||
6204|008|Z|specific health needs.||
6204|009|B|||
6204|010|T|LORATADINE/PSEUDOEPHEDRINE SUSTAINED-RELEASE - ORAL||
6204|011|F|(lor-AT-a-deen/SOO-doe-e-FED-rin)||
6204|012|B|||
6204|013|C|COMMON BRAND NAME(S): Claritin-D||
6204|014|B|||
6204|015|U|USES:  Loratadine is an antihistamine which provides relief of||
6204|016|U|seasonal allergy symptoms such as watery and itching eyes, runny||
6204|017|U|nose, and sneezing. Pseudoephedrine is a decongestant which helps||
6204|018|U|relieve a stuffy nose, promotes sinus draining, and improves||
6204|019|U|breathing.||
6204|020|U|   This medication is not recommended for use in children under||
6204|021|U|12 years of age due to the high amount of pseudoephedrine.||
6204|022|B|||
6204|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
6204|024|H|doctor, usually twice daily (every 12 hours) with a full glass of||
6204|025|H|water.||
6204|026|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
6204|027|H|Doing so can release all of the drug at once, increasing the risk||
6204|028|H|of side effects.||
6204|029|H|   Do not increase your dose or take this more often than||
6204|030|H|directed.||
6204|031|H|   Tell your doctor if your condition does not get better or if||
6204|032|H|it gets worse.||
6204|033|B|||
6204|034|S|SIDE EFFECTS:  Dry mouth, mild stomach upset, trouble sleeping,||
6204|035|S|dizziness, headache, nervousness, loss of appetite, or thirst may||
6204|036|S|occur. If any of these effects last or get worse, tell your||
6204|037|S|doctor or pharmacist promptly.||
6204|038|S|   If your doctor has directed you to use this medication,||
6204|039|S|remember that your doctor has judged that the benefit to you is||
6204|040|S|greater than the risk of side effects. Many people using this||
6204|041|S|medication do not have serious side effects.||
6204|042|S|   This medication may raise your blood pressure. Check your||
6204|043|S|blood pressure regularly and tell your doctor if the results are||
6204|044|S|high.||
6204|045|S|   Tell your doctor right away if you have any serious side||
6204|046|S|effects, including: fast/irregular heartbeat, uncontrolled||
6204|047|S|shaking or tremor, mental/mood changes (such as confusion),||
6204|048|S|difficulty urinating.||
6204|049|S|   Get medical help right away if you have any very serious side||
6204|050|S|effects, including: seizures.||
6204|051|S|   A very serious allergic reaction to this drug is rare.||
6204|052|S|However, get medical help right away if you notice any symptoms||
6204|053|S|of a serious allergic reaction, including: rash, itching/swelling||
6204|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6204|055|S|breathing.||
6204|056|S|   This is not a complete list of possible side effects. If you||
6204|057|S|notice other effects not listed above, contact your doctor or||
6204|058|S|pharmacist.||
6204|059|S|   In the US -||
6204|060|S|   Call your doctor for medical advice about side effects. You||
6204|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6204|062|S|www.fda.gov/medwatch.||
6204|063|S|   In Canada - Call your doctor for medical advice about side||
6204|064|S|effects. You may report side effects to Health Canada at||
6204|065|S|1-866-234-2345.||
6204|066|B|||
6204|067|P|PRECAUTIONS:  Before taking loratadine with pseudoephedrine, tell||
6204|068|P|your doctor or pharmacist if you are allergic to it; or to||
6204|069|P|desloratadine; or if you have any other allergies. Also, tell||
6204|070|P|your doctor if you have had serious side effects from similar||
6204|071|P|medications (such as other decongestants, including||
6204|072|P|phenylephrine). This product may contain inactive ingredients,||
6204|073|P|which can cause allergic reactions or other problems. Talk to||
6204|074|P|your pharmacist for more details.||
6204|075|P|   Before using this medication, tell your doctor or pharmacist||
6204|076|P|your medical history, especially of: kidney disease, liver||
6204|077|P|disease, problems urinating (such as due to enlarged prostate),||
6204|078|P|high blood pressure, diabetes, heart problems (such as coronary||
6204|079|P|artery disease), thyroid problems (hyperthyroidism), glaucoma.||
6204|080|P|   This drug may make you dizzy. Alcohol or marijuana can make||
6204|081|P|you more dizzy. Do not drive, use machinery, or do anything that||
6204|082|P|needs alertness until you can do it safely. Limit alcoholic||
6204|083|P|beverages. Talk to your doctor if you are using marijuana.||
6204|084|P|   Before having surgery, tell your doctor or dentist about all||
6204|085|P|the products you use (including prescription drugs,||
6204|086|P|nonprescription drugs, and herbal products).||
6204|087|P|   Older adults may be more sensitive to the side effects of this||
6204|088|P|drug, especially fast/irregular heartbeat, dizziness, problems||
6204|089|P|urinating, trouble sleeping, or confusion. Dizziness, trouble||
6204|090|P|sleeping, and confusion can increase the risk of falling.||
6204|091|P|   During pregnancy, this medication should be used only when||
6204|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
6204|093|P|   This medication passes into breast milk. Consult your doctor||
6204|094|P|before breastfeeding.||
6204|095|B|||
6204|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6204|097|I|medications work or increase your risk for serious side effects.||
6204|098|I|This document does not contain all possible drug interactions.||
6204|099|I|Keep a list of all the products you use (including||
6204|100|I|prescription/nonprescription drugs and herbal products) and share||
6204|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
6204|102|I|the dosage of any medicines without your doctor's approval.||
6204|103|I|   Taking MAO inhibitors with this medication may cause a serious||
6204|104|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
6204|105|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
6204|106|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
6204|107|I|selegiline, tranylcypromine) during treatment with this||
6204|108|I|medication. Most MAO inhibitors should also not be taken for two||
6204|109|I|weeks before treatment with this medication. Ask your doctor when||
6204|110|I|to start or stop taking this medication.||
6204|111|I|   Check the labels on all your medicines (such as cough-and-cold||
6204|112|I|products) because they may contain similar ingredients||
6204|113|I|(decongestants such as phenylephrine). Ask your pharmacist about||
6204|114|I|using those products safely.||
6204|115|I|   Loratadine is very similar to desloratadine. Do not use||
6204|116|I|medications containing desloratadine while using loratadine.||
6204|117|I|   This medication may interfere with certain lab tests (such as||
6204|118|I|allergy skin testing), possibly causing false test results. Make||
6204|119|I|sure lab personnel and all your doctors know you use this drug.||
6204|120|B|||
6204|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6204|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6204|123|O|poison control center right away. US residents can call||
6204|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6204|125|O|Symptoms of overdose may include: irregular or unusually slow or||
6204|126|O|fast heartbeat, unusual nervousness or excitement, and seizures.||
6204|127|B|||
6204|128|N|NOTES:  Do not share this medication with others.||
6204|129|B|||
6204|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6204|131|D|If it is near the time of the next dose, skip the missed dose.||
6204|132|D|Use your next dose at the regular time. Do not double the dose to||
6204|133|D|catch up.||
6204|134|B|||
6204|135|R|STORAGE:  Store at room temperature away from light and moisture.||
6204|136|R|Do not store in the bathroom. Keep all medications away from||
6204|137|R|children and pets.||
6204|138|R|   Do not flush medications down the toilet or pour them into a||
6204|139|R|drain unless instructed to do so. Properly discard this product||
6204|140|R|when it is expired or no longer needed. Consult your pharmacist||
6204|141|R|or local waste disposal company.||
6204|142|B|||
6204|143|A|Information last revised November 2025.||
6204|144|A|Copyright(c) 2025 First Databank, Inc.||
6204|145|B|||
6205|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6205|002|Z|does NOT have all possible information about this product. This||
6205|003|Z|information does not assure that this product is safe, effective,||
6205|004|Z|or appropriate for you. This information is not individual||
6205|005|Z|medical advice and does not substitute for the advice of your||
6205|006|Z|health care professional. Always ask your health care||
6205|007|Z|professional for complete information about this product and your||
6205|008|Z|specific health needs.||
6205|009|B|||
6205|010|T|ALPROSTADIL SUPPOSITORY - PENILE||
6205|011|F|(al-PROS-ta-dil)||
6205|012|B|||
6205|013|C|COMMON BRAND NAME(S): Muse||
6205|014|B|||
6205|015|U|USES:  This medication is used to treat male sexual function||
6205|016|U|problems (erectile dysfunction). It works by helping the blood||
6205|017|U|flow into the penis to achieve and maintain an erection.||
6205|018|U|   This medication is not for use in women or children.||
6205|019|U|   This medication does not protect against sexually transmitted||
6205|020|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
6205|021|U|an effective barrier method (latex or polyurethane condom/dental||
6205|022|U|dams) during sexual activity will help to decrease your risk of||
6205|023|U|infection.||
6205|024|B|||
6205|025|H|HOW TO USE:  Read the Patient Information Leaflet and||
6205|026|H|Instructions for Use if available from your pharmacist before you||
6205|027|H|start using alprostadil and each time you get a refill. Learn all||
6205|028|H|preparation and usage instructions. If you have any questions,||
6205|029|H|ask your doctor or pharmacist.||
6205|030|H|   This medication is used by inserting the suppository into the||
6205|031|H|penis as directed by your doctor. Remove the protective cover||
6205|032|H|from the applicator before inserting into the penis. The dosage||
6205|033|H|is based on your medical condition and response to treatment.||
6205|034|H|This medication should usually work within 5 to 10 minutes to||
6205|035|H|produce an erection that lasts for about 30 to 60 minutes. Do not||
6205|036|H|use more than 2 doses in a 24-hour period.||
6205|037|H|   Tell your doctor if your condition lasts or gets worse (for||
6205|038|H|example, the drug does not produce an erection or it becomes more||
6205|039|H|difficult to get an erection).||
6205|040|B|||
6205|041|S|SIDE EFFECTS:  Penis/testicle/groin pain, minor bleeding or||
6205|042|S|spotting from the penis, dizziness, swelling (especially of leg||
6205|043|S|veins), and rapid heartbeat may occur. If any of these effects||
6205|044|S|last or get worse, tell your doctor or pharmacist promptly.||
6205|045|S|   Remember that this medication has been prescribed because your||
6205|046|S|doctor has judged that the benefit to you is greater than the||
6205|047|S|risk of side effects. Many people using this medication do not||
6205|048|S|have serious side effects.||
6205|049|S|   Tell your doctor right away if you have any serious side||
6205|050|S|effects, including: fainting.||
6205|051|S|   Rarely, males may have a painful or prolonged erection lasting||
6205|052|S|4 or more hours. If this occurs, stop using this drug and get||
6205|053|S|medical help right away, or permanent problems could occur.||
6205|054|S|   In female partners, vaginal burning/itching may occur. It is||
6205|055|S|not clear if this side effect is caused by the medication or||
6205|056|S|sexual intercourse itself. The use of a water-based lubricant may||
6205|057|S|help prevent vaginal irritation.||
6205|058|S|   A very serious allergic reaction to this drug is rare.||
6205|059|S|However, get medical help right away if you notice any symptoms||
6205|060|S|of a serious allergic reaction, including: rash, itching/swelling||
6205|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6205|062|S|breathing.||
6205|063|S|   This is not a complete list of possible side effects. If you||
6205|064|S|notice other effects not listed above, contact your doctor or||
6205|065|S|pharmacist.||
6205|066|S|   In the US -||
6205|067|S|   Call your doctor for medical advice about side effects. You||
6205|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6205|069|S|www.fda.gov/medwatch.||
6205|070|S|   In Canada - Call your doctor for medical advice about side||
6205|071|S|effects. You may report side effects to Health Canada at||
6205|072|S|1-866-234-2345.||
6205|073|B|||
6205|074|P|PRECAUTIONS:  Before using alprostadil, tell your doctor or||
6205|075|P|pharmacist if you are allergic to it; or if you have any other||
6205|076|P|allergies. This product may contain inactive ingredients, which||
6205|077|P|can cause allergic reactions or other problems. Talk to your||
6205|078|P|pharmacist for more details.||
6205|079|P|   Before using this medication, tell your doctor or pharmacist||
6205|080|P|your medical history, especially of: penis conditions (such as||
6205|081|P|angulation, cavernosal fibrosis, Peyronie's disease, urethral||
6205|082|P|stricture/obstruction, urethritis, infection), indwelling||
6205|083|P|urethral catheter, bleeding disorders, blood system cancers (such||
6205|084|P|as leukemia, multiple myeloma), heart disease, low blood||
6205|085|P|pressure, sickle cell anemia.||
6205|086|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6205|087|P|can make you more dizzy. Do not drive, use machinery, or do||
6205|088|P|anything that needs alertness until you can do it safely. Limit||
6205|089|P|alcoholic beverages. Talk to your doctor if you are using||
6205|090|P|marijuana (cannabis).||
6205|091|P|   Before having surgery, tell your doctor or dentist about all||
6205|092|P|the products you use (including prescription drugs,||
6205|093|P|nonprescription drugs, and herbal products).||
6205|094|P|   This medication is not for use in women. If this drug is used||
6205|095|P|by a male for sexual intercourse with a pregnant woman, an||
6205|096|P|effective barrier method such as a latex or polyurethane condom||
6205|097|P|should be used. Consult your doctor or pharmacist for more||
6205|098|P|details.||
6205|099|B|||
6205|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6205|101|I|medications work or increase your risk for serious side effects.||
6205|102|I|This document does not contain all possible drug interactions.||
6205|103|I|Keep a list of all the products you use (including||
6205|104|I|prescription/nonprescription drugs and herbal products) and share||
6205|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
6205|106|I|the dosage of any medicines without your doctor's approval.||
6205|107|B|||
6205|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6205|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6205|110|O|poison control center right away. US residents can call||
6205|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6205|112|O|Symptoms of overdose may include: fainting, painful/prolonged||
6205|113|O|erection.||
6205|114|B|||
6205|115|N|NOTES:  Do not share this medication with others.||
6205|116|B|||
6205|117|D|MISSED DOSE:  Not applicable.||
6205|118|B|||
6205|119|R|STORAGE:  Store unopened foil pouches in the refrigerator. This||
6205|120|R|medication may also be stored at room temperature for up to 14||
6205|121|R|days if needed. Keep all medications away from children and pets.||
6205|122|R|   Do not flush medications down the toilet or pour them into a||
6205|123|R|drain unless instructed to do so. Properly discard this product||
6205|124|R|when it is expired or no longer needed. Consult your pharmacist||
6205|125|R|or local waste disposal company.||
6205|126|B|||
6205|127|A|Information last revised October 2025.||
6205|128|A|Copyright(c) 2025 First Databank, Inc.||
6205|129|B|||
6216|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6216|002|Z|does NOT have all possible information about this product. This||
6216|003|Z|information does not assure that this product is safe, effective,||
6216|004|Z|or appropriate for you. This information is not individual||
6216|005|Z|medical advice and does not substitute for the advice of your||
6216|006|Z|health care professional. Always ask your health care||
6216|007|Z|professional for complete information about this product and your||
6216|008|Z|specific health needs.||
6216|009|B|||
6216|010|T|HEMIN - INJECTION||
6216|011|F|(HEE-min)||
6216|012|B|||
6216|013|C|COMMON BRAND NAME(S): Panhematin||
6216|014|B|||
6216|015|U|USES:  This medication is used to treat the symptoms that occur||
6216|016|U|with certain blood disorders (porphyrias). Hemin is not a cure||
6216|017|U|for porphyria. This medication may relieve symptoms such as pain,||
6216|018|U|high blood pressure, rapid heartbeat, or mental changes that may||
6216|019|U|occur during an acute attack of porphyria.||
6216|020|B|||
6216|021|H|HOW TO USE:  This medication is given by injection into a vein by||
6216|022|H|a health care professional. It is given as directed by your||
6216|023|H|doctor, usually once daily.||
6216|024|H|   The dosage is based on your weight, medical condition, and||
6216|025|H|response to treatment.||
6216|026|B|||
6216|027|S|SIDE EFFECTS:  Discoloration of the skin or pain, tenderness, or||
6216|028|S|swelling along your veins may occur. If any of these effects last||
6216|029|S|or get worse, tell your doctor or pharmacist promptly.||
6216|030|S|   Remember that this medication has been prescribed because your||
6216|031|S|doctor has judged that the benefit to you is greater than the||
6216|032|S|risk of side effects. Many people using this medication do not||
6216|033|S|have serious side effects.||
6216|034|S|   Tell your doctor right away if you have any serious side||
6216|035|S|effects, including: easy bruising/bleeding.||
6216|036|S|   A very serious allergic reaction to this drug is rare.||
6216|037|S|However, get medical help right away if you notice any symptoms||
6216|038|S|of a serious allergic reaction, including: rash, itching/swelling||
6216|039|S|(especially of the face/tongue/throat), dizziness, trouble||
6216|040|S|breathing.||
6216|041|S|   This is not a complete list of possible side effects. If you||
6216|042|S|notice other effects not listed above, contact your doctor or||
6216|043|S|pharmacist.||
6216|044|S|   In the US -||
6216|045|S|   Call your doctor for medical advice about side effects. You||
6216|046|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6216|047|S|www.fda.gov/medwatch.||
6216|048|S|   In Canada - Call your doctor for medical advice about side||
6216|049|S|effects. You may report side effects to Health Canada at||
6216|050|S|1-866-234-2345.||
6216|051|B|||
6216|052|P|PRECAUTIONS:  Before using hemin, tell your doctor or pharmacist||
6216|053|P|if you are allergic to it; or if you have any other allergies.||
6216|054|P|This product may contain inactive ingredients, which can cause||
6216|055|P|allergic reactions or other problems. Talk to your pharmacist for||
6216|056|P|more details.||
6216|057|P|   Before using this medication, tell your doctor or pharmacist||
6216|058|P|your medical history.||
6216|059|P|   This medication is made from human blood. Even though the||
6216|060|P|blood is carefully tested, and this medication goes through a||
6216|061|P|special manufacturing process, there is an extremely small chance||
6216|062|P|that you may get infections from the medication. Consult your||
6216|063|P|doctor or pharmacist for more information.||
6216|064|P|   Before having surgery, tell your doctor or dentist about all||
6216|065|P|the products you use (including prescription drugs,||
6216|066|P|nonprescription drugs, and herbal products).||
6216|067|P|   During pregnancy, this medication should be used only when||
6216|068|P|clearly needed. Discuss the risks and benefits with your doctor.||
6216|069|P|   It is unknown if this drug passes into breast milk. Consult||
6216|070|P|your doctor before breastfeeding.||
6216|071|B|||
6216|072|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6216|073|I|medications work or increase your risk for serious side effects.||
6216|074|I|This document does not contain all possible drug interactions.||
6216|075|I|Keep a list of all the products you use (including||
6216|076|I|prescription/nonprescription drugs and herbal products) and share||
6216|077|I|it with your doctor and pharmacist. Do not start, stop, or change||
6216|078|I|the dosage of any medicines without your doctor's approval.||
6216|079|I|   Some products that may interact with this drug are:||
6216|080|I|barbiturates (such as pentobarbital, phenobarbital), "blood||
6216|081|I|thinners" (anticoagulants such as heparin, warfarin),||
6216|082|I|corticosteroids (such as prednisone), estrogens.||
6216|083|B|||
6216|084|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6216|085|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6216|086|O|poison control center right away. US residents can call||
6216|087|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6216|088|O|Symptoms of overdose may include: signs of kidney problems (such||
6216|089|O|as change in the amount of urine).||
6216|090|B|||
6216|091|N|NOTES:  Lab and/or medical tests (such as iron/ferritin levels)||
6216|092|N|should be done while you are using this medication. Keep all||
6216|093|N|medical and lab appointments. Consult your doctor for more||
6216|094|N|details.||
6216|095|B|||
6216|096|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
6216|097|D|right away for a new dosing schedule.||
6216|098|B|||
6216|099|R|STORAGE:  Not applicable. This medication is given in a hospital||
6216|100|R|or clinic and will not be stored at home.||
6216|101|B|||
6216|102|A|Information last revised May 2024.||
6216|103|A|Copyright(c) 2025 First Databank, Inc.||
6216|104|B|||
6217|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6217|002|Z|does NOT have all possible information about this product. This||
6217|003|Z|information does not assure that this product is safe, effective,||
6217|004|Z|or appropriate for you. This information is not individual||
6217|005|Z|medical advice and does not substitute for the advice of your||
6217|006|Z|health care professional. Always ask your health care||
6217|007|Z|professional for complete information about this product and your||
6217|008|Z|specific health needs.||
6217|009|B|||
6217|010|T|VIGABATRIN - ORAL||
6217|011|F|(vye-GA-ba-trin)||
6217|012|B|||
6217|013|C|COMMON BRAND NAME(S): Sabril||
6217|014|B|||
6217|015|W|WARNING:  Serious vision problems may occur while taking this||
6217|016|W|medication and may be permanent even after you stop taking the||
6217|017|W|medication. To prevent vision problems from getting worse, your||
6217|018|W|doctor must find any eye problems as early as possible. Also,||
6217|019|W|tell your doctor if you have a history of vision problems. It is||
6217|020|W|very important that you have an eye exam before or within 4 weeks||
6217|021|W|of starting this medication, then every 3 months thereafter while||
6217|022|W|you are taking this medication. You should also have an eye exam||
6217|023|W|3 to 6 months after stopping this medication. Follow your||
6217|024|W|doctor's directions carefully and keep all medical/eye/lab||
6217|025|W|appointments. Tell your doctor right away if you have any changes||
6217|026|W|in vision (such as loss of vision, blurred vision, double vision,||
6217|027|W|sensitivity to light, eye pain).||
6217|028|W|   To receive vigabatrin in the United States, you must||
6217|029|W|understand, agree to, and carefully follow the requirements of||
6217|030|W|the REMS Program for this medication. If you live in Canada or||
6217|031|W|any other country, consult your doctor and pharmacist for your||
6217|032|W|country's regulations.||
6217|033|B|||
6217|034|U|USES:  This medication is used in combination with other||
6217|035|U|medications to treat seizure disorders (epilepsy). Vigabatrin||
6217|036|U|decreases the number of seizures in adults and children who have||
6217|037|U|not been able to control their seizures with other treatment.||
6217|038|U|Vigabatrin is an anticonvulsant. It is thought to work by||
6217|039|U|stopping the breakdown of a natural calming substance (GABA) in||
6217|040|U|the brain.||
6217|041|B|||
6217|042|H|HOW TO USE:  Read the Medication Guide provided by your||
6217|043|H|pharmacist before you start taking vigabatrin and each time you||
6217|044|H|get a refill. If you have any questions, ask your doctor or||
6217|045|H|pharmacist.||
6217|046|H|   Take this medication by mouth with or without food as directed||
6217|047|H|by your doctor, usually twice a day.||
6217|048|H|   The dosage is based on your medical condition and response to||
6217|049|H|treatment. Children's dosage is also based on weight. Your doctor||
6217|050|H|may direct you to take a low dose at first, gradually increasing||
6217|051|H|the dose to lower the chance of side effects such as drowsiness||
6217|052|H|and confusion. Your doctor will adjust your dose to find the best||
6217|053|H|dose for you. Follow your doctor's directions carefully.||
6217|054|H|   Take this medication regularly to get the most benefit from||
6217|055|H|it. To help you remember, take it at the same times each day.||
6217|056|H|   Do not increase your dose or take this medication more often||
6217|057|H|than prescribed. Your condition will not improve any faster, and||
6217|058|H|the risk of serious side effects may be increased. Do not stop||
6217|059|H|taking this medication without consulting your doctor. Your||
6217|060|H|seizures may become worse when the drug is suddenly stopped. Your||
6217|061|H|dose may need to be gradually decreased.||
6217|062|H|   Tell your doctor if your seizures get worse or if they do not||
6217|063|H|get better within 3 months.||
6217|064|B|||
6217|065|S|SIDE EFFECTS:  See also Warning section.||
6217|066|S|   Drowsiness, dizziness, and difficulty concentrating may occur,||
6217|067|S|especially during the first few days as your body adjusts to the||
6217|068|S|medication. Children may become restless or excited. Nausea,||
6217|069|S|vomiting, stomach upset, diarrhea, headache, weight gain, and||
6217|070|S|tiredness may also occur. If any of these effects last or get||
6217|071|S|worse, tell your doctor or pharmacist promptly.||
6217|072|S|   Remember that this medication has been prescribed because your||
6217|073|S|doctor has judged that the benefit to you is greater than the||
6217|074|S|risk of side effects. Many people using this medication do not||
6217|075|S|have serious side effects.||
6217|076|S|   Tell your doctor right away if you have any serious side||
6217|077|S|effects, including: shakiness (tremor), swelling ankles/feet,||
6217|078|S|tingling/numbness, shortness of breath, fast heartbeat.||
6217|079|S|   A small number of people who take anticonvulsants for any||
6217|080|S|condition (such as seizure, bipolar disorder, pain) may||
6217|081|S|experience depression, suicidal thoughts/attempts, or other||
6217|082|S|mental/mood problems. Tell your doctor right away if you or your||
6217|083|S|family/caregiver notice any unusual/sudden changes in your mood,||
6217|084|S|thoughts, or behavior including signs of depression, suicidal||
6217|085|S|thoughts/attempts, thoughts about harming yourself.||
6217|086|S|   A very serious allergic reaction to this drug is rare.||
6217|087|S|However, get medical help right away if you notice any symptoms||
6217|088|S|of a serious allergic reaction, including: rash, itching/swelling||
6217|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6217|090|S|breathing.||
6217|091|S|   This is not a complete list of possible side effects. If you||
6217|092|S|notice other effects not listed above, contact your doctor or||
6217|093|S|pharmacist.||
6217|094|S|   In the US -||
6217|095|S|   Call your doctor for medical advice about side effects. You||
6217|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6217|097|S|www.fda.gov/medwatch.||
6217|098|S|   In Canada - Call your doctor for medical advice about side||
6217|099|S|effects. You may report side effects to Health Canada at||
6217|100|S|1-866-234-2345.||
6217|101|B|||
6217|102|P|PRECAUTIONS:  Before taking vigabatrin, tell your doctor or||
6217|103|P|pharmacist if you are allergic to it; or if you have any other||
6217|104|P|allergies. This product may contain inactive ingredients, which||
6217|105|P|can cause allergic reactions or other problems. Talk to your||
6217|106|P|pharmacist for more details.||
6217|107|P|   Before using this medication, tell your doctor or pharmacist||
6217|108|P|your medical history, especially of: eye problems (such as visual||
6217|109|P|field defect, glaucoma, macular degeneration, optic nerve||
6217|110|P|problem), mental/mood problems (such as depression, psychosis),||
6217|111|P|kidney disease, low red blood cell count (anemia).||
6217|112|P|   This drug may make you dizzy or drowsy or cause vision||
6217|113|P|problems. Alcohol or marijuana (cannabis) can make you more dizzy||
6217|114|P|or drowsy. Do not drive, use machinery, or do anything that needs||
6217|115|P|alertness or clear vision until you can do it safely. Avoid||
6217|116|P|alcoholic beverages. Talk to your doctor if you are using||
6217|117|P|marijuana (cannabis).||
6217|118|P|   MRI tests of the brain in infants have shown changes after||
6217|119|P|they are given vigabatrin. It is not known if these changes are||
6217|120|P|harmful. Consult your doctor for more details. If your infant is||
6217|121|P|going to have an MRI test, notify testing personnel that your||
6217|122|P|infant is using this medication.||
6217|123|P|   Before having surgery, tell your doctor or dentist about all||
6217|124|P|the products you use (including prescription drugs,||
6217|125|P|nonprescription drugs, and herbal products).||
6217|126|P|   Older adults may be at greater risk for side effects (such as||
6217|127|P|confusion) while using this drug. Confusion can increase the risk||
6217|128|P|of falling.||
6217|129|P|   Tell your doctor if you are pregnant or plan to become||
6217|130|P|pregnant. You should not become pregnant while using vigabatrin.||
6217|131|P|Vigabatrin may harm an unborn baby. Ask about reliable forms of||
6217|132|P|birth control while using this medication. If you become||
6217|133|P|pregnant, talk to your doctor right away about the risks and||
6217|134|P|benefits of this medication.||
6217|135|P|   This medication passes into breast milk in small amounts.||
6217|136|P|Consult your doctor before breastfeeding.||
6217|137|B|||
6217|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6217|139|I|medications work or increase your risk for serious side effects.||
6217|140|I|This document does not contain all possible drug interactions.||
6217|141|I|Keep a list of all the products you use (including||
6217|142|I|prescription/nonprescription drugs and herbal products) and share||
6217|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
6217|144|I|the dosage of any medicines without your doctor's approval.||
6217|145|I|   Some products that may interact with this drug include: drugs||
6217|146|I|that can harm the eye (retinotoxic drugs such as chloroquine,||
6217|147|I|hydroxychloroquine, phenothiazines including thioridazine),||
6217|148|I|orlistat.||
6217|149|I|   Tell your doctor or pharmacist if you are taking other||
6217|150|I|products that cause drowsiness including alcohol, marijuana||
6217|151|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
6217|152|I|drugs for sleep or anxiety (such as alprazolam, clonazepam,||
6217|153|I|diazepam, zolpidem), muscle relaxants, and opioid pain relievers||
6217|154|I|(such as codeine).||
6217|155|I|   Check the labels on all your medicines (such as allergy or||
6217|156|I|cough-and-cold products) because they may contain ingredients||
6217|157|I|that cause drowsiness. Ask your pharmacist about using those||
6217|158|I|products safely.||
6217|159|I|   This medication may interfere with certain lab tests (such as||
6217|160|I|liver function tests), possibly causing false test results. Make||
6217|161|I|sure lab personnel and all your doctors know you use this drug.||
6217|162|B|||
6217|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6217|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6217|165|O|poison control center right away. US residents can call||
6217|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6217|167|O|Symptoms of overdose may include: slow/shallow breathing, loss of||
6217|168|O|consciousness.||
6217|169|B|||
6217|170|N|NOTES:  Do not share this medication with others.||
6217|171|N|   Lab and/or medical tests (such as eye exams, kidney function,||
6217|172|N|complete blood count) should be done while you are taking this||
6217|173|N|medication. Keep all medical and lab appointments. Consult your||
6217|174|N|doctor for more details.||
6217|175|B|||
6217|176|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6217|177|D|remember. If it is near the time of the next dose, skip the||
6217|178|D|missed dose. Take your next dose at the regular time. Do not||
6217|179|D|double the dose to catch up.||
6217|180|B|||
6217|181|R|STORAGE:  Store at room temperature away from light and moisture.||
6217|182|R|Do not store in the bathroom. Keep all medications away from||
6217|183|R|children and pets.||
6217|184|R|   Do not flush medications down the toilet or pour them into a||
6217|185|R|drain unless instructed to do so. Properly discard this product||
6217|186|R|when it is expired or no longer needed. Consult your pharmacist||
6217|187|R|or local waste disposal company.||
6217|188|B|||
6217|189|M|MEDICAL ALERT:  Your condition can cause complications in a||
6217|190|M|medical emergency. For information about enrolling in MedicAlert,||
6217|191|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6217|192|B|||
6217|193|A|Information last revised November 2024.||
6217|194|A|Copyright(c) 2025 First Databank, Inc.||
6217|195|B|||
6218|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6218|002|Z|does NOT have all possible information about this product. This||
6218|003|Z|information does not assure that this product is safe, effective,||
6218|004|Z|or appropriate for you. This information is not individual||
6218|005|Z|medical advice and does not substitute for the advice of your||
6218|006|Z|health care professional. Always ask your health care||
6218|007|Z|professional for complete information about this product and your||
6218|008|Z|specific health needs.||
6218|009|B|||
6218|010|T|GALANTAMINE - ORAL||
6218|011|F|(ga-LAN-ta-meen)||
6218|012|B|||
6218|013|C|COMMON BRAND NAME(S): Razadyne, Reminyl||
6218|014|B|||
6218|015|U|USES:  Galantamine is used to treat mild to moderate confusion||
6218|016|U|(dementia) related to Alzheimer's disease. It does not cure||
6218|017|U|Alzheimer's disease, but it may improve memory, awareness, and||
6218|018|U|the ability to perform daily functions. This medication works by||
6218|019|U|restoring the balance of certain natural substances||
6218|020|U|(neurotransmitters) in the brain.||
6218|021|B|||
6218|022|H|HOW TO USE:  Read the Instructions for Use if available from your||
6218|023|H|pharmacist before you start taking galantamine and each time you||
6218|024|H|get a refill. If you have any questions, ask your doctor or||
6218|025|H|pharmacist.||
6218|026|H|   Take this medication by mouth with food as directed by your||
6218|027|H|doctor, usually twice daily with the morning and evening meals.||
6218|028|H|Drink plenty of fluids with this medication unless instructed||
6218|029|H|otherwise. The dosage is based on your medical condition and||
6218|030|H|response to treatment. To reduce your risk of side effects, your||
6218|031|H|doctor may direct you to start this medication at a low dose and||
6218|032|H|gradually increase your dose. Follow your doctor's instructions||
6218|033|H|carefully.||
6218|034|H|   If you are using the liquid form of this medication, carefully||
6218|035|H|measure the dose using a special measuring device/spoon. Do not||
6218|036|H|use a household spoon because you may not get the correct dose.||
6218|037|H|Mix your dose of medication in about 4 ounces (120 milliliters)||
6218|038|H|of nonalcoholic beverage, stir, and drink the entire mixture||
6218|039|H|right away.||
6218|040|H|   If you stop taking galantamine for longer than 3 days, consult||
6218|041|H|your doctor before restarting your medication. Your doctor may||
6218|042|H|direct you to restart this medication at a low dose.||
6218|043|H|   Use this medication regularly to get the most benefit from it.||
6218|044|H|To help you remember, take it at the same times each day.||
6218|045|H|   Do not increase your dose or use this drug more often or for||
6218|046|H|longer than prescribed. Your condition will not improve any||
6218|047|H|faster, and your risk of side effects will increase.||
6218|048|H|   It may take at least 4 weeks of continued use to get the full||
6218|049|H|benefit of this drug.||
6218|050|H|   Tell your doctor if your condition gets worse.||
6218|051|B|||
6218|052|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, dizziness, drowsiness,||
6218|053|S|loss of appetite, or weight loss may occur. If any of these||
6218|054|S|effects last or get worse, tell your doctor or pharmacist||
6218|055|S|promptly.||
6218|056|S|   Remember that this medication has been prescribed because your||
6218|057|S|doctor has judged that the benefit to you is greater than the||
6218|058|S|risk of side effects. Many people using this medication do not||
6218|059|S|have serious side effects.||
6218|060|S|   Tell your doctor right away if you have any serious side||
6218|061|S|effects, including: slow heartbeat, difficulty urinating.||
6218|062|S|   Get medical help right away if you have any very serious side||
6218|063|S|effects, including: seizures, black/bloody stools, vomit that||
6218|064|S|looks bloody or like coffee grounds, severe stomach/abdominal||
6218|065|S|pain, fast/irregular heartbeat, severe dizziness, fainting.||
6218|066|S|   A very serious allergic reaction to this drug is rare.||
6218|067|S|However, get medical help right away if you notice any symptoms||
6218|068|S|of a serious allergic reaction, including: rash, itching/swelling||
6218|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6218|070|S|breathing.||
6218|071|S|   This is not a complete list of possible side effects. If you||
6218|072|S|notice other effects not listed above, contact your doctor or||
6218|073|S|pharmacist.||
6218|074|S|   In the US -||
6218|075|S|   Call your doctor for medical advice about side effects. You||
6218|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6218|077|S|www.fda.gov/medwatch.||
6218|078|S|   In Canada - Call your doctor for medical advice about side||
6218|079|S|effects. You may report side effects to Health Canada at||
6218|080|S|1-866-234-2345.||
6218|081|B|||
6218|082|P|PRECAUTIONS:  Before taking galantamine, tell your doctor or||
6218|083|P|pharmacist if you are allergic to it; or to benzgalantamine or to||
6218|084|P|daffodil plants; or if you have any other allergies. This product||
6218|085|P|may contain inactive ingredients, which can cause allergic||
6218|086|P|reactions or other problems. Talk to your pharmacist for more||
6218|087|P|details.||
6218|088|P|   Before using this medication, tell your doctor or pharmacist||
6218|089|P|your medical history, especially of: liver problems, kidney||
6218|090|P|problems, stomach/intestinal problems (such as ulcers, bleeding),||
6218|091|P|heart problems (such as sick sinus syndrome, AV block,||
6218|092|P|arrhythmias), breathing/lung problems (such as asthma, chronic||
6218|093|P|obstructive pulmonary disease-COPD), seizures, problems urinating||
6218|094|P|(such as due to enlarged prostate).||
6218|095|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6218|096|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6218|097|P|machinery, or do anything that needs alertness until you can do||
6218|098|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
6218|099|P|are using marijuana (cannabis).||
6218|100|P|   Galantamine may cause a condition that affects the heart||
6218|101|P|rhythm (QT prolongation). QT prolongation can rarely cause||
6218|102|P|serious (rarely fatal) fast/irregular heartbeat and other||
6218|103|P|symptoms (such as severe dizziness, fainting) that need medical||
6218|104|P|attention right away.||
6218|105|P|   The risk of QT prolongation may be increased if you have||
6218|106|P|certain medical conditions or are taking other drugs that may||
6218|107|P|cause QT prolongation. Before using galantamine, tell your doctor||
6218|108|P|or pharmacist of all the drugs you take and if you have any of||
6218|109|P|the following conditions: certain heart problems (heart failure,||
6218|110|P|slow heartbeat, QT prolongation in the EKG), family history of||
6218|111|P|certain heart problems (QT prolongation in the EKG, sudden||
6218|112|P|cardiac death).||
6218|113|P|   Low levels of potassium or magnesium in the blood may also||
6218|114|P|increase your risk of QT prolongation. This risk may increase if||
6218|115|P|you use certain drugs (such as diuretics/"water pills") or if you||
6218|116|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6218|117|P|Talk to your doctor about using galantamine safely.||
6218|118|P|   Before having surgery, tell your doctor or dentist about all||
6218|119|P|the products you use (including prescription drugs,||
6218|120|P|nonprescription drugs, and herbal products).||
6218|121|P|   Older adults may be more sensitive to the side effects of this||
6218|122|P|drug, especially QT prolongation (see above).||
6218|123|P|   During pregnancy, this medication should be used only when||
6218|124|P|clearly needed. Discuss the risks and benefits with your doctor.||
6218|125|P|   It is unknown if this drug passes into breast milk. Consult||
6218|126|P|your doctor before breastfeeding.||
6218|127|B|||
6218|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6218|129|I|medications work or increase your risk for serious side effects.||
6218|130|I|This document does not contain all possible drug interactions.||
6218|131|I|Keep a list of all the products you use (including||
6218|132|I|prescription/nonprescription drugs and herbal products) and share||
6218|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
6218|134|I|the dosage of any medicines without your doctor's approval.||
6218|135|I|   Other medications can affect the removal of galantamine from||
6218|136|I|your body, which may affect how galantamine works. Examples||
6218|137|I|include amitriptyline, azole antifungals (such as ketoconazole),||
6218|138|I|quinidine, SSRI antidepressants (such as paroxetine), among||
6218|139|I|others.||
6218|140|I|   Galantamine is very similar to benzgalantamine. Do not use||
6218|141|I|medications containing benzgalantamine while using galantamine.||
6218|142|B|||
6218|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6218|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6218|145|O|poison control center right away. US residents can call||
6218|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6218|147|O|Symptoms of overdose may include muscle weakness or twitching,||
6218|148|O|severe stomach cramping, slow or shallow breathing,||
6218|149|O|slow/fast/irregular heartbeat, fainting, and seizures.||
6218|150|B|||
6218|151|N|NOTES:  Do not share this medication with others.||
6218|152|N|   Lab and/or medical tests (such as weight monitoring) should be||
6218|153|N|done before you start taking this medication and while you are||
6218|154|N|taking it. Keep all medical and lab appointments. Consult your||
6218|155|N|doctor for more details.||
6218|156|B|||
6218|157|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6218|158|D|remember. If it is near the time of the next dose, skip the||
6218|159|D|missed dose. Take your next dose at the regular time. Do not||
6218|160|D|double the dose to catch up.||
6218|161|B|||
6218|162|R|STORAGE:  Store at room temperature away from light and moisture.||
6218|163|R|Do not store in the bathroom. Do not freeze. Keep all medications||
6218|164|R|away from children and pets.||
6218|165|R|   Do not flush medications down the toilet or pour them into a||
6218|166|R|drain unless instructed to do so. Properly discard this product||
6218|167|R|when it is expired or no longer needed. Consult your pharmacist||
6218|168|R|or local waste disposal company.||
6218|169|B|||
6218|170|A|Information last revised March 2025.||
6218|171|A|Copyright(c) 2025 First Databank, Inc.||
6218|172|B|||
6220|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6220|002|Z|does NOT have all possible information about this product. This||
6220|003|Z|information does not assure that this product is safe, effective,||
6220|004|Z|or appropriate for you. This information is not individual||
6220|005|Z|medical advice and does not substitute for the advice of your||
6220|006|Z|health care professional. Always ask your health care||
6220|007|Z|professional for complete information about this product and your||
6220|008|Z|specific health needs.||
6220|009|B|||
6220|010|T|BECAPLERMIN GEL - TOPICAL||
6220|011|F|(be-KAP-ler-min)||
6220|012|B|||
6220|013|C|COMMON BRAND NAME(S): Regranex||
6220|014|B|||
6220|015|U|USES:  This medication is used to treat certain foot/leg ulcers||
6220|016|U|in people with diabetes. It is used along with good foot/leg care||
6220|017|U|(such as keeping pressure off the wound) to help the ulcer heal||
6220|018|U|completely. Becaplermin works by attracting certain natural||
6220|019|U|substances to the ulcer that help wound healing.||
6220|020|B|||
6220|021|H|HOW TO USE:  Read the Medication Guide and, if available, the||
6220|022|H|Instructions for Use provided by your pharmacist before you start||
6220|023|H|using becaplermin and each time you get a refill. If you have any||
6220|024|H|questions, ask your doctor or pharmacist.||
6220|025|H|   Wash hands thoroughly before applying this medicine. To avoid||
6220|026|H|contaminating the container tip, do not touch it to the skin or||
6220|027|H|any other surface. Learn all preparation and usage instructions||
6220|028|H|in the product package. If any of the information is unclear,||
6220|029|H|consult your doctor or pharmacist.||
6220|030|H|   The amount of the medication applied is based on the size of||
6220|031|H|the ulcer. Your doctor or wound specialist should adjust your||
6220|032|H|dose every 1 to 2 weeks.||
6220|033|H|   Squeeze the prescribed amount of medication onto a clean,||
6220|034|H|firm, and non-absorbent surface (such as waxed paper). Use a||
6220|035|H|clean applicator (such as a cotton swab, tongue depressor) to||
6220|036|H|apply a thin layer of the medication evenly over the ulcer as||
6220|037|H|directed by your doctor, usually once daily.||
6220|038|H|   Cover the ulcer with wound dressing as directed by your||
6220|039|H|doctor. After 12 hours, remove the dressing, rinse the ulcer, and||
6220|040|H|apply new dressing on the ulcer. Do not apply more medication at||
6220|041|H|this time.||
6220|042|H|   Use this medication regularly in order to get the most benefit||
6220|043|H|from it. To help you remember, use it at the same time each day.||
6220|044|H|Use this medication until the ulcer heals completely.||
6220|045|H|   Do not apply a thick layer of the medication or use more of||
6220|046|H|the medication than directed. This will not increase the effects||
6220|047|H|of the medication or help the wound heal faster and may increase||
6220|048|H|the risk of side effects. Talk to your doctor for more details.||
6220|049|H|   Tell your doctor if your condition gets worse, does not get||
6220|050|H|better after 10 weeks, or does not heal completely after 20||
6220|051|H|weeks.||
6220|052|B|||
6220|053|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
6220|054|S|because your doctor has judged that the benefit to you is greater||
6220|055|S|than the risk of side effects. Many people using this medication||
6220|056|S|do not have serious side effects.||
6220|057|S|   A very serious allergic reaction to this drug is rare.||
6220|058|S|However, get medical help right away if you notice any symptoms||
6220|059|S|of a serious allergic reaction, including: rash, itching/swelling||
6220|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6220|061|S|breathing.||
6220|062|S|   This is not a complete list of possible side effects. If you||
6220|063|S|notice other effects not listed above, contact your doctor or||
6220|064|S|pharmacist.||
6220|065|S|   In the US -||
6220|066|S|   Call your doctor for medical advice about side effects. You||
6220|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6220|068|S|www.fda.gov/medwatch.||
6220|069|S|   In Canada - Call your doctor for medical advice about side||
6220|070|S|effects. You may report side effects to Health Canada at||
6220|071|S|1-866-234-2345.||
6220|072|B|||
6220|073|P|PRECAUTIONS:  Before using becaplermin, tell your doctor or||
6220|074|P|pharmacist if you are allergic to it; or if you have any other||
6220|075|P|allergies. This product may contain inactive ingredients (such as||
6220|076|P|parabens), which can cause allergic reactions or other problems.||
6220|077|P|Talk to your pharmacist for more details.||
6220|078|P|   Before using this medication, tell your doctor or pharmacist||
6220|079|P|your medical history, especially of: cancer (especially in the||
6220|080|P|ulcer area).||
6220|081|P|   Before having surgery, tell your doctor or dentist about all||
6220|082|P|the products you use (including prescription drugs,||
6220|083|P|nonprescription drugs, and herbal products).||
6220|084|P|   During pregnancy, this medication should be used only when||
6220|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
6220|086|P|   It is unknown if this drug passes into breast milk. Consult||
6220|087|P|your doctor before breastfeeding.||
6220|088|B|||
6220|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6220|090|I|medications work or increase your risk for serious side effects.||
6220|091|I|This document does not contain all possible drug interactions.||
6220|092|I|Keep a list of all the products you use (including||
6220|093|I|prescription/nonprescription drugs and herbal products) and share||
6220|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
6220|095|I|the dosage of any medicines without your doctor's approval.||
6220|096|B|||
6220|097|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6220|098|O|has overdosed and has serious symptoms such as passing out or||
6220|099|O|trouble breathing, call 911. Otherwise, call a poison control||
6220|100|O|center right away. US residents can call 1-800-222-1222. Canada||
6220|101|O|residents can call 1-844-764-7669.||
6220|102|B|||
6220|103|N|NOTES:  Do not share this medication with others.||
6220|104|N|   This medication has been prescribed for your current wound||
6220|105|N|only. Do not use it later for another wound unless told to do so||
6220|106|N|by your doctor. A different medication may be necessary in that||
6220|107|N|case.||
6220|108|N|   Good foot care can help reduce the chances of foot ulcers.||
6220|109|N|Wash your feet daily and check for cuts, sores, or blisters. Keep||
6220|110|N|your toenails neat and trimmed. Choose shoes that are||
6220|111|N|well-fitting, and always wear socks with your shoes.||
6220|112|B|||
6220|113|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6220|114|D|If it is near the time of the next dose, skip the missed dose.||
6220|115|D|Use your next dose at the regular time. Do not double the dose to||
6220|116|D|catch up.||
6220|117|B|||
6220|118|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
6220|119|R|medications away from children and pets.||
6220|120|R|   Do not flush medications down the toilet or pour them into a||
6220|121|R|drain unless instructed to do so. Properly discard this product||
6220|122|R|when it is expired or no longer needed. Consult your pharmacist||
6220|123|R|or local waste disposal company.||
6220|124|B|||
6220|125|A|Information last revised November 2024.||
6220|126|A|Copyright(c) 2025 First Databank, Inc.||
6220|127|B|||
6221|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6221|002|Z|does NOT have all possible information about this product. This||
6221|003|Z|information does not assure that this product is safe, effective,||
6221|004|Z|or appropriate for you. This information is not individual||
6221|005|Z|medical advice and does not substitute for the advice of your||
6221|006|Z|health care professional. Always ask your health care||
6221|007|Z|professional for complete information about this product and your||
6221|008|Z|specific health needs.||
6221|009|B|||
6221|010|T|SODIUM/POTASSIUM PHOSPHATE, MONOBASIC-DIBASIC POWDER - ORAL||
6221|011|F|(SOE-de-um/poe-TAS-ee-um FOS-fate,MON-oh-BAY-sik,dye-BAY-sik)||
6221|012|B|||
6221|013|C|COMMON BRAND NAME(S): Neutra-Phos||
6221|014|B|||
6221|015|U|USES:  This drug is used in people who cannot get enough||
6221|016|U|phosphorus from their diets. Phosphorus is a natural body mineral||
6221|017|U|that is needed for the body to work normally. It is needed for||
6221|018|U|building and keeping strong bones. It also helps control the||
6221|019|U|amount of calcium in the body and urine.||
6221|020|B|||
6221|021|H|HOW TO USE:  Take this medication by mouth as directed by your||
6221|022|H|doctor, usually 4 times a day with meals and at bedtime. Open the||
6221|023|H|packet and mix the powder in one-third of a glass (2.5 ounces or||
6221|024|H|75 milliliters) of water or other liquid such as juice. Stir the||
6221|025|H|mixture well before taking all of it.||
6221|026|H|   Dosage is based on your medical condition and response to||
6221|027|H|treatment.||
6221|028|H|   Take this medication regularly in order to get the most||
6221|029|H|benefit from it. To help you remember, take it at the same times||
6221|030|H|each day.||
6221|031|H|   Take this medication 2 to 3 hours before or after taking any||
6221|032|H|products containing magnesium, aluminum, or calcium. Some||
6221|033|H|examples include quinapril, vitamins/minerals, and antacids.||
6221|034|H|Dairy products (such as milk, yogurt), juice with added calcium,||
6221|035|H|iron, and zinc are also included. These products bind with||
6221|036|H|phosphate, preventing its full absorption.||
6221|037|H|   If your doctor has recommended that you follow a special diet,||
6221|038|H|it is very important to follow the diet to get the most benefit||
6221|039|H|from this medication and prevent serious side effects. Do not||
6221|040|H|take other supplements/vitamins unless ordered by your doctor.||
6221|041|H|   If you are unsure about how to take this medication, ask your||
6221|042|H|doctor or pharmacist.||
6221|043|B|||
6221|044|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, dizziness,||
6221|045|S|or stomach/abdominal pain may occur. If any of these effects last||
6221|046|S|or get worse, tell your doctor or pharmacist promptly.||
6221|047|S|   If your doctor has directed you to use this medication,||
6221|048|S|remember that your doctor has judged that the benefit to you is||
6221|049|S|greater than the risk of side effects. Many people using this||
6221|050|S|medication do not have serious side effects.||
6221|051|S|   When this medication is first started, there is a chance an||
6221|052|S|old kidney stone will be passed. Tell your doctor right away if||
6221|053|S|you develop any symptoms of a kidney stone passing, including:||
6221|054|S|painful/frequent urination, sudden/severe pain in the||
6221|055|S|side/back/abdomen, blood in the urine.||
6221|056|S|   Tell your doctor right away if you have any serious side||
6221|057|S|effects, including: bone/joint pain, muscle cramps, swelling||
6221|058|S|ankles/feet, sudden weight gain, fast/irregular heartbeat, signs||
6221|059|S|of kidney problems (such as change in the amount of urine),||
6221|060|S|tingling/numbness of the hands/feet/lips, confusion, seizures,||
6221|061|S|unusual weakness/tiredness, shortness of breath.||
6221|062|S|   A very serious allergic reaction to this drug is rare.||
6221|063|S|However, get medical help right away if you notice any symptoms||
6221|064|S|of a serious allergic reaction, including: rash, itching/swelling||
6221|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6221|066|S|breathing.||
6221|067|S|   This is not a complete list of possible side effects. If you||
6221|068|S|notice other side effects not listed above, contact your doctor||
6221|069|S|or pharmacist.||
6221|070|S|   In the US -||
6221|071|S|   Call your doctor for medical advice about side effects. You||
6221|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6221|073|S|www.fda.gov/medwatch.||
6221|074|S|   In Canada - Call your doctor for medical advice about side||
6221|075|S|effects. You may report side effects to Health Canada at||
6221|076|S|1-866-234-2345.||
6221|077|B|||
6221|078|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
6221|079|P|pharmacist if you are allergic to it; or if you have any other||
6221|080|P|allergies. This product may contain inactive ingredients, which||
6221|081|P|can cause allergic reactions or other problems. Talk to your||
6221|082|P|pharmacist for more details.||
6221|083|P|   Before using this medication, tell your doctor or pharmacist||
6221|084|P|your medical history, especially of: high||
6221|085|P|phosphate/potassium/sodium levels, adrenal gland problems (such||
6221|086|P|as Addison's disease), bone problems (such as rickets,||
6221|087|P|osteomalacia), kidney disease (including kidney stones), heart||
6221|088|P|disease (such as heart failure), high blood pressure, a certain||
6221|089|P|hormone problem (hypoparathyroidism), a certain muscle problem||
6221|090|P|(myotonia congenita), liver disease, dehydration, too much body||
6221|091|P|water (such as swelling of arms/legs, fluid in the lungs), severe||
6221|092|P|burns/wounds, swelling of the pancreas (pancreatitis), a diet||
6221|093|P|restricted in sodium or potassium.||
6221|094|P|   This medication contains sodium. Consult your doctor for more||
6221|095|P|information if you are on a salt-restricted diet or if increased||
6221|096|P|salt intake could worsen your condition (such as heart failure).||
6221|097|P|   Before having surgery, tell your doctor or dentist about all||
6221|098|P|the products you use (including prescription drugs,||
6221|099|P|nonprescription drugs, and herbal products).||
6221|100|P|   During pregnancy, this medication should be used only when||
6221|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
6221|102|P|   It is unknown if this drug passes into breast milk. Consult||
6221|103|P|your doctor before breastfeeding.||
6221|104|B|||
6221|105|I|DRUG INTERACTIONS:  See also How to Use section.||
6221|106|I|   Drug interactions may change how your medications work or||
6221|107|I|increase your risk for serious side effects. This document does||
6221|108|I|not contain all possible drug interactions. Keep a list of all||
6221|109|I|the products you use (including prescription/nonprescription||
6221|110|I|drugs and herbal products) and share it with your doctor and||
6221|111|I|pharmacist. Do not start, stop, or change the dosage of any||
6221|112|I|medicines without your doctor's approval.||
6221|113|I|   Some products that may interact with this drug include:||
6221|114|I|burosumab, corticosteroids (such as prednisone), digoxin, drugs||
6221|115|I|that are affected by acid levels in the urine (such as||
6221|116|I|chlorpropamide, methadone), medications that may increase||
6221|117|I|potassium levels (such as eplerenone, ACE inhibitors such as||
6221|118|I|lisinopril, ARBs such as valsartan, potassium-sparing||
6221|119|I|diuretics/"water pills" such as||
6221|120|I|amiloride/spironolactone/triamterene, birth control pills||
6221|121|I|containing drospirenone), potassium supplements/salt substitutes.||
6221|122|B|||
6221|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6221|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6221|125|O|poison control center right away. US residents can call||
6221|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6221|127|O|Symptoms of overdose may include: severe diarrhea, muscle spasms.||
6221|128|B|||
6221|129|N|NOTES:  Do not share this medication with others.||
6221|130|N|   Lab and/or medical tests (such as||
6221|131|N|calcium/phosphorus/potassium/sodium levels, kidney function)||
6221|132|N|should be done while you are taking this medication. Keep all||
6221|133|N|medical and lab appointments. Consult your doctor for more||
6221|134|N|details.||
6221|135|B|||
6221|136|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6221|137|D|remember. If it is near the time of the next dose, skip the||
6221|138|D|missed dose. Take your next dose at the regular time. Do not||
6221|139|D|double the dose to catch up.||
6221|140|B|||
6221|141|R|STORAGE:  Store at room temperature away from heat and moisture.||
6221|142|R|Do not store in the bathroom. Keep all medications away from||
6221|143|R|children and pets.||
6221|144|R|   Do not flush medications down the toilet or pour them into a||
6221|145|R|drain unless instructed to do so. Properly discard this product||
6221|146|R|when it is expired or no longer needed. Consult your pharmacist||
6221|147|R|or local waste disposal company.||
6221|148|B|||
6221|149|A|Information last revised September 2025.||
6221|150|A|Copyright(c) 2025 First Databank, Inc.||
6221|151|B|||
6223|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6223|002|Z|does NOT have all possible information about this product. This||
6223|003|Z|information does not assure that this product is safe, effective,||
6223|004|Z|or appropriate for you. This information is not individual||
6223|005|Z|medical advice and does not substitute for the advice of your||
6223|006|Z|health care professional. Always ask your health care||
6223|007|Z|professional for complete information about this product and your||
6223|008|Z|specific health needs.||
6223|009|B|||
6223|010|T|AZITHROMYCIN POWDER PACKET - ORAL||
6223|011|F|(ay-ZITH-roe-MYE-sin)||
6223|012|B|||
6223|013|C|COMMON BRAND NAME(S): Zithromax||
6223|014|B|||
6223|015|U|USES:  Azithromycin is an antibiotic (macrolide-type). This||
6223|016|U|single-dose form of the medication is used to treat certain||
6223|017|U|infections, including genital infections. It works by stopping||
6223|018|U|the growth of bacteria.||
6223|019|U|   This medication will not work for viral infections (such as||
6223|020|U|common cold, flu). Unnecessary use or misuse of any antibiotic||
6223|021|U|can lead to its decreased effectiveness.||
6223|022|U|   This form of azithromycin is not intended for use by children.||
6223|023|B|||
6223|024|H|HOW TO USE:  Take this medication by mouth, with or without food.||
6223|025|H|Taking it with food may help reduce stomach upset. Mix the||
6223|026|H|contents of one packet in 2 ounces (60 milliliters) of water.||
6223|027|H|Drink this right away. Add another 2 ounces of water, mix, and||
6223|028|H|drink the entire amount.||
6223|029|H|   Tell your doctor if your condition lasts or gets worse.||
6223|030|B|||
6223|031|S|SIDE EFFECTS:  Stomach upset, diarrhea/loose stools, nausea,||
6223|032|S|vomiting, or abdominal pain may occur. If any of these effects||
6223|033|S|last or get worse, tell your doctor or pharmacist promptly.||
6223|034|S|   Remember that this medication has been prescribed because your||
6223|035|S|doctor has judged that the benefit to you is greater than the||
6223|036|S|risk of side effects. Many people using this medication do not||
6223|037|S|have serious side effects.||
6223|038|S|   Tell your doctor right away if you have any serious side||
6223|039|S|effects, including: hearing changes (such as decreased hearing,||
6223|040|S|deafness), eye problems (such as drooping eyelids, blurred||
6223|041|S|vision), difficulty speaking/swallowing, muscle weakness, signs||
6223|042|S|of liver problems (such as nausea/vomiting that doesn't stop,||
6223|043|S|unusual tiredness, severe stomach/abdominal pain, yellowing||
6223|044|S|eyes/skin, dark urine).||
6223|045|S|   Get medical help right away if you have any very serious side||
6223|046|S|effects, including: fast/irregular heartbeat, severe dizziness,||
6223|047|S|fainting.||
6223|048|S|   This medication may rarely cause a severe intestinal condition||
6223|049|S|due to a bacteria called C. difficile. This condition may occur||
6223|050|S|during treatment or weeks to months after treatment has stopped.||
6223|051|S|Tell your doctor right away if you develop: diarrhea that doesn't||
6223|052|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
6223|053|S|stool.||
6223|054|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
6223|055|S|products because they may make symptoms worse||
6223|056|S|   Use of this medication for prolonged or repeated periods may||
6223|057|S|result in oral thrush or a new yeast infection. Contact your||
6223|058|S|doctor if you notice white patches in your mouth, a change in||
6223|059|S|vaginal discharge, or other new symptoms.||
6223|060|S|   A very serious allergic reaction to this drug is rare.||
6223|061|S|However, get medical help right away if you notice any symptoms||
6223|062|S|of a serious allergic reaction, including: fever that doesn't go||
6223|063|S|away, new or worsening lymph node swelling, rash,||
6223|064|S|itching/swelling (especially of the face/tongue/throat), severe||
6223|065|S|dizziness, trouble breathing.||
6223|066|S|   An allergic reaction to this medication may return even if you||
6223|067|S|stop the drug. If you have an allergic reaction, continue to||
6223|068|S|watch for any of the above symptoms for several days after your||
6223|069|S|last dose.||
6223|070|S|   This is not a complete list of possible side effects. If you||
6223|071|S|notice other effects not listed above, contact your doctor or||
6223|072|S|pharmacist.||
6223|073|S|   In the US -||
6223|074|S|   Call your doctor for medical advice about side effects. You||
6223|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6223|076|S|www.fda.gov/medwatch.||
6223|077|S|   In Canada - Call your doctor for medical advice about side||
6223|078|S|effects. You may report side effects to Health Canada at||
6223|079|S|1-866-234-2345.||
6223|080|B|||
6223|081|P|PRECAUTIONS:  Before taking azithromycin, tell your doctor or||
6223|082|P|pharmacist if you are allergic to it; or to other antibiotics||
6223|083|P|(such as erythromycin, clarithromycin, telithromycin); or if you||
6223|084|P|have any other allergies. This product may contain inactive||
6223|085|P|ingredients, which can cause allergic reactions or other||
6223|086|P|problems. Talk to your pharmacist for more details.||
6223|087|P|   Before using this medication, tell your doctor or pharmacist||
6223|088|P|your medical history, especially of: liver disease, kidney||
6223|089|P|disease, a certain muscle disease (myasthenia gravis).||
6223|090|P|   Azithromycin may cause a condition that affects the heart||
6223|091|P|rhythm (QT prolongation). QT prolongation can rarely cause||
6223|092|P|serious (rarely fatal) fast/irregular heartbeat and other||
6223|093|P|symptoms (such as severe dizziness, fainting) that need medical||
6223|094|P|attention right away.||
6223|095|P|   The risk of QT prolongation may be increased if you have||
6223|096|P|certain medical conditions or are taking other drugs that may||
6223|097|P|cause QT prolongation. Before using azithromycin, tell your||
6223|098|P|doctor or pharmacist of all the drugs you take and if you have||
6223|099|P|any of the following conditions: certain heart problems (heart||
6223|100|P|failure, slow heartbeat, QT prolongation in the EKG), family||
6223|101|P|history of certain heart problems (QT prolongation in the EKG,||
6223|102|P|sudden cardiac death).||
6223|103|P|   Low levels of potassium or magnesium in the blood may also||
6223|104|P|increase your risk of QT prolongation. This risk may increase if||
6223|105|P|you use certain drugs (such as diuretics/"water pills") or if you||
6223|106|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6223|107|P|Talk to your doctor about using azithromycin safely.||
6223|108|P|   Azithromycin may cause live bacterial vaccines (such as||
6223|109|P|typhoid vaccine) to not work well. Tell your health care||
6223|110|P|professional that you are using azithromycin before having any||
6223|111|P|immunizations/vaccinations.||
6223|112|P|   Before having surgery, tell your doctor or dentist about all||
6223|113|P|the products you use (including prescription drugs,||
6223|114|P|nonprescription drugs, and herbal products).||
6223|115|P|   Older adults may be more sensitive to the side effects of this||
6223|116|P|drug, especially QT prolongation (see above).||
6223|117|P|   During pregnancy, this medication should be used only when||
6223|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
6223|119|P|   This drug passes into breast milk. Consult your doctor before||
6223|120|P|breastfeeding.||
6223|121|B|||
6223|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6223|123|I|medications work or increase your risk for serious side effects.||
6223|124|I|This document does not contain all possible drug interactions.||
6223|125|I|Keep a list of all the products you use (including||
6223|126|I|prescription/nonprescription drugs and herbal products) and share||
6223|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
6223|128|I|the dosage of any medicines without your doctor's approval.||
6223|129|I|   This medication can slow down the removal of other medications||
6223|130|I|from your body, which may affect how they work. Examples of||
6223|131|I|affected drugs include colchicine, among others.||
6223|132|I|   Many drugs besides azithromycin may affect the heart rhythm||
6223|133|I|(QT prolongation), including amiodarone, chloroquine,||
6223|134|I|disopyramide, dofetilide, dronedarone, hydroxychloroquine,||
6223|135|I|ibutilide, pimozide, procainamide, quinidine, sotalol, among||
6223|136|I|others.||
6223|137|B|||
6223|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6223|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6223|140|O|poison control center right away. US residents can call||
6223|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6223|142|B|||
6223|143|N|NOTES:  Do not share this medication with others.||
6223|144|B|||
6223|145|D|MISSED DOSE:  Not applicable.||
6223|146|B|||
6223|147|R|STORAGE:  Store at room temperature away from light and moisture.||
6223|148|R|Do not store in the bathroom. Keep all medications away from||
6223|149|R|children and pets.||
6223|150|R|   Do not flush medications down the toilet or pour them into a||
6223|151|R|drain unless instructed to do so. Properly discard this product||
6223|152|R|when it is expired or no longer needed. Consult your pharmacist||
6223|153|R|or local waste disposal company.||
6223|154|B|||
6223|155|A|Information last revised December 2024.||
6223|156|A|Copyright(c) 2025 First Databank, Inc.||
6223|157|B|||
6227|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6227|002|Z|does NOT have all possible information about this product. This||
6227|003|Z|information does not assure that this product is safe, effective,||
6227|004|Z|or appropriate for you. This information is not individual||
6227|005|Z|medical advice and does not substitute for the advice of your||
6227|006|Z|health care professional. Always ask your health care||
6227|007|Z|professional for complete information about this product and your||
6227|008|Z|specific health needs.||
6227|009|B|||
6227|010|T|CITRIC ACID/SODIUM CITRATE - ORAL||
6227|011|F|(SIT-rik AS-id/SOE-dee-um SI-trate)||
6227|012|B|||
6227|013|C|COMMON BRAND NAME(S): Bicitra, Cytra-2, Oracit, Shohl's||
6227|014|B|||
6227|015|U|USES:  This medication is used to make the urine less acidic.||
6227|016|U|Urine that is less acidic helps the kidneys get rid of uric acid,||
6227|017|U|helping to prevent gout and certain types of kidney stones||
6227|018|U|(urate). This medication can also prevent and treat certain||
6227|019|U|metabolic problems (acidosis) caused by kidney disease.||
6227|020|U|   Citric acid and citrate salts (which contain potassium and||
6227|021|U|sodium) belong to a class of drugs known as urinary alkalinizers.||
6227|022|U|Because some conditions require you to limit your intake of||
6227|023|U|potassium and sodium, your doctor's choice of product may depend||
6227|024|U|on how much potassium and sodium you can take.||
6227|025|B|||
6227|026|H|HOW TO USE:  Shake the container well before each dose. Take this||
6227|027|H|medication by mouth as directed by your doctor, usually 4 times a||
6227|028|H|day. To help prevent diarrhea and stomach upset, take each dose||
6227|029|H|after a meal, and mix your prescribed dose of medication in a||
6227|030|H|full glass (4 to 8 ounces or 120 to 240 milliliters) of cold||
6227|031|H|water or juice just before taking, or take as directed by your||
6227|032|H|doctor. Drink the entire mixture slowly. Ask your doctor or||
6227|033|H|pharmacist for further instructions.||
6227|034|H|   The liquid form of this medication must be mixed with at least||
6227|035|H|4 ounces (120 milliliters) of water or juice before taking.||
6227|036|H|   Refrigerating the mixture before drinking may improve the||
6227|037|H|taste. Drink more water or juice after taking this medication||
6227|038|H|unless otherwise directed by your doctor.||
6227|039|H|   Dosage is based on your medical condition and response to||
6227|040|H|treatment.||
6227|041|H|   Take this medication as prescribed. Do not increase your dose||
6227|042|H|or take this more often without your doctor's approval. Use this||
6227|043|H|medication regularly to get the most benefit from it. To help you||
6227|044|H|remember, take it at the same times each day.||
6227|045|H|   While taking this medication, you may need to test the pH||
6227|046|H|(acidity) of your urine using special paper. The pH will help||
6227|047|H|determine the proper dose. Consult your doctor or pharmacist for||
6227|048|H|more information.||
6227|049|B|||
6227|050|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, and stomach pain may||
6227|051|S|occur. Mixing the medication with water or juice, taking it after||
6227|052|S|meals, and drinking more fluids will help prevent these side||
6227|053|S|effects. If any of these effects last or get worse, tell your||
6227|054|S|doctor or pharmacist promptly.||
6227|055|S|   Remember that this medication has been prescribed because your||
6227|056|S|doctor has judged that the benefit to you is greater than the||
6227|057|S|risk of side effects. Many people using this medication do not||
6227|058|S|have serious side effects.||
6227|059|S|   Tell your doctor right away if you have any serious side||
6227|060|S|effects, including: swelling of the hands/ankles/feet,||
6227|061|S|tingling/numbness of the hands/feet, weakness,||
6227|062|S|fast/slow/irregular heartbeat, mental/mood changes (such as||
6227|063|S|confusion, restlessness), muscle spasms, seizures.||
6227|064|S|   A very serious allergic reaction to this drug is rare.||
6227|065|S|However, get medical help right away if you notice any symptoms||
6227|066|S|of a serious allergic reaction, including: rash, itching/swelling||
6227|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6227|068|S|breathing.||
6227|069|S|   This is not a complete list of possible side effects. If you||
6227|070|S|notice other effects not listed above, contact your doctor or||
6227|071|S|pharmacist.||
6227|072|S|   In the US -||
6227|073|S|   Call your doctor for medical advice about side effects. You||
6227|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6227|075|S|www.fda.gov/medwatch.||
6227|076|S|   In Canada - Call your doctor for medical advice about side||
6227|077|S|effects. You may report side effects to Health Canada at||
6227|078|S|1-866-234-2345.||
6227|079|B|||
6227|080|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
6227|081|P|pharmacist if you are allergic to it; or if you have any other||
6227|082|P|allergies. This product may contain inactive ingredients, which||
6227|083|P|can cause allergic reactions or other problems. Talk to your||
6227|084|P|pharmacist for more details.||
6227|085|P|   Before using this medication, tell your doctor or pharmacist||
6227|086|P|your medical history, especially of: a sodium-restricted diet,||
6227|087|P|mineral imbalance (such as high sodium or low calcium levels),||
6227|088|P|extra fluid in the body (such as swelling of arms/legs, fluid in||
6227|089|P|the lungs), high blood pressure, heart problems (such as||
6227|090|P|irregular heartbeat, heart failure), kidney disease.||
6227|091|P|   Liquid forms of this product may contain sugar. Caution is||
6227|092|P|advised if you have diabetes. Ask your doctor or pharmacist about||
6227|093|P|using this product safely.||
6227|094|P|   Because this medication contains salt (sodium), tell your||
6227|095|P|doctor if you are on a salt-restricted diet.||
6227|096|P|   During pregnancy, this medication should be used only when||
6227|097|P|clearly needed. This medication may worsen high blood pressure||
6227|098|P|during pregnancy (toxemia of pregnancy). Discuss the risks and||
6227|099|P|benefits with your doctor.||
6227|100|P|   It is unknown if this drug passes into breast milk. Consult||
6227|101|P|your doctor before breastfeeding.||
6227|102|B|||
6227|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6227|104|I|medications work or increase your risk for serious side effects.||
6227|105|I|This document does not contain all possible drug interactions.||
6227|106|I|Keep a list of all the products you use (including||
6227|107|I|prescription/nonprescription drugs and herbal products) and share||
6227|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
6227|109|I|the dosage of any medicines without your doctor's approval.||
6227|110|I|   Some products that may interact with this drug are: antacids||
6227|111|I|that contain aluminum, aspirin and other salicylates (such as||
6227|112|I|salsalate), lithium, quinidine.||
6227|113|I|   If your doctor has told you to take low-dose aspirin to||
6227|114|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
6227|115|I|you should keep taking the aspirin unless your doctor tells you||
6227|116|I|not to. Ask your doctor or pharmacist for more details.||
6227|117|B|||
6227|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6227|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6227|120|O|poison control center right away. US residents can call||
6227|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6227|122|O|Symptoms of overdose may include: muscle spasms, seizures.||
6227|123|B|||
6227|124|N|NOTES:  Do not share this medication with others.||
6227|125|N|   Lab and/or medical tests (such as sodium levels) should be||
6227|126|N|done while you are taking this medication. Keep all medical and||
6227|127|N|lab appointments. Consult your doctor for more details.||
6227|128|B|||
6227|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6227|130|D|remember. If it is near the time of the next dose, skip the||
6227|131|D|missed dose. Take your next dose at the regular time. Do not||
6227|132|D|double the dose to catch up.||
6227|133|B|||
6227|134|R|STORAGE:  Store at room temperature away from heat, light, and||
6227|135|R|moisture. Do not freeze. Do not store in the bathroom. Keep all||
6227|136|R|medications away from children and pets.||
6227|137|R|   Do not flush medications down the toilet or pour them into a||
6227|138|R|drain unless instructed to do so. Properly discard this product||
6227|139|R|when it is expired or no longer needed. Consult your pharmacist||
6227|140|R|or local waste disposal company.||
6227|141|B|||
6227|142|A|Information last revised May 2024.||
6227|143|A|Copyright(c) 2025 First Databank, Inc.||
6227|144|B|||
6238|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6238|002|Z|does NOT have all possible information about this product. This||
6238|003|Z|information does not assure that this product is safe, effective,||
6238|004|Z|or appropriate for you. This information is not individual||
6238|005|Z|medical advice and does not substitute for the advice of your||
6238|006|Z|health care professional. Always ask your health care||
6238|007|Z|professional for complete information about this product and your||
6238|008|Z|specific health needs.||
6238|009|B|||
6238|010|T|GUAIFENESIN/DECONGESTANT/OPIOID ANTITUSSIVE/ANTIHISTAMINE - ORAL||
6238|011|B|||
6238|012|W|WARNING:  This medication has a risk for abuse and addiction,||
6238|013|W|which can lead to overdose and death. This medication may also||
6238|014|W|cause severe, possibly fatal, breathing problems. To lower your||
6238|015|W|risk, your doctor should have you take the smallest dose that||
6238|016|W|works, and take it for the shortest possible time. See also How||
6238|017|W|to Use section for more information about addiction.||
6238|018|W|   The risk for severe breathing problems is higher when you||
6238|019|W|start this medication, or if you take the wrong dose or take more||
6238|020|W|of this medication than prescribed. Taking this medication with||
6238|021|W|alcohol or other drugs that can cause drowsiness or breathing||
6238|022|W|problems may cause very serious side effects, including death.||
6238|023|W|Also, other medications can affect the removal of this product||
6238|024|W|from your body, which may affect how it works. Be sure you know||
6238|025|W|how to take this product and what other drugs you should avoid||
6238|026|W|taking with it. See also Drug Interactions section. Get medical||
6238|027|W|help right away if any of these very serious side effects occur:||
6238|028|W|slow/shallow breathing, unusual lightheadedness, severe||
6238|029|W|drowsiness/dizziness, difficulty waking up.||
6238|030|W|   Keep this medicine in a safe place to prevent theft, misuse,||
6238|031|W|or abuse. If someone accidentally swallows this drug, get medical||
6238|032|W|help right away.||
6238|033|W|   Before using this medication, women of childbearing age should||
6238|034|W|talk with their doctor(s) about the risks and benefits. Tell your||
6238|035|W|doctor if you are pregnant or think you may be pregnant. During||
6238|036|W|pregnancy, this medication is not recommended. It may slightly||
6238|037|W|increase the risk of birth defects if used during the first two||
6238|038|W|months of pregnancy. Also, using it for a long time or in high||
6238|039|W|doses near the expected delivery date may harm the unborn baby.||
6238|040|W|To lessen the risk, take the smallest effective dose for the||
6238|041|W|shortest possible time. Babies born to mothers who use this drug||
6238|042|W|for a long time may develop severe (possibly fatal) withdrawal||
6238|043|W|symptoms. Tell the doctor right away if you notice any symptoms||
6238|044|W|in your newborn baby such as crying that doesn't stop,||
6238|045|W|slow/shallow breathing, irritability, shaking, vomiting,||
6238|046|W|diarrhea, poor feeding, or difficulty gaining weight.||
6238|047|B|||
6238|048|U|USES:  This combination product is used to treat symptoms caused||
6238|049|U|by the common cold, flu, allergies, hay fever, or other breathing||
6238|050|U|illnesses (such as sinusitis, bronchitis). Guaifenesin is an||
6238|051|U|expectorant that helps to thin and loosen mucus in the lungs,||
6238|052|U|making it easier to cough up the mucus. Decongestants relieve||
6238|053|U|stuffy nose symptoms. This product also contains an opioid cough||
6238|054|U|suppressant (antitussive) that affects a certain part of the||
6238|055|U|brain, reducing the urge to cough. Antihistamines relieve watery||
6238|056|U|eyes, itchy eyes/nose/throat, runny nose, and sneezing.||
6238|057|U|   This medication is not usually used for ongoing coughs from||
6238|058|U|smoking, asthma, other long-term breathing problems (such as||
6238|059|U|emphysema), or coughs with a lot of mucus, unless directed by||
6238|060|U|your doctor.||
6238|061|U|   Opioid cough suppressants should not be used by children||
6238|062|U|younger than 18 years. Children are at higher risk for serious||
6238|063|U|(even fatal) side effects, especially breathing problems. Talk||
6238|064|U|with the doctor about the risks and benefits of this medication.||
6238|065|U|   Cough-and-cold products do not cure colds. Cough due to a||
6238|066|U|common cold often does not need to be treated with medicine. Ask||
6238|067|U|your doctor or pharmacist about other ways to relieve cough and||
6238|068|U|cold symptoms, such as drinking enough fluids, using a||
6238|069|U|humidifier, or saline nose drops/spray.||
6238|070|B|||
6238|071|H|HOW TO USE:  Take this medication by mouth with or without food||
6238|072|H|with a full glass of water (8 ounces or 240 milliliters) as||
6238|073|H|directed by your doctor. Drink plenty of fluids when you use this||
6238|074|H|medication unless otherwise directed by your doctor. The fluid||
6238|075|H|will help loosen the mucus in your lungs. This medication may be||
6238|076|H|taken with food or milk if stomach upset occurs. Carefully||
6238|077|H|measure the dose using a special measuring device/spoon. Do not||
6238|078|H|use a household spoon because you may not get the correct dose.||
6238|079|H|   Do not increase your dose or use this product more often or||
6238|080|H|for longer than prescribed. Your condition will not improve any||
6238|081|H|faster, and your risk of side effects will increase.||
6238|082|H|   If you suddenly stop using this medication, you may have||
6238|083|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
6238|084|H|nose, nausea, sweating, muscle aches). To help prevent||
6238|085|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
6238|086|H|more likely if you have used this medication regularly for a long||
6238|087|H|time (more than a few weeks) or in high doses. Tell your doctor||
6238|088|H|or pharmacist right away if you have withdrawal.||
6238|089|H|   Though it helps many people, this product may sometimes cause||
6238|090|H|addiction. This risk may be higher if you have a mental/mood||
6238|091|H|disorder or a substance use disorder (such as overuse of or||
6238|092|H|addiction to drugs/alcohol). Take this product exactly as||
6238|093|H|prescribed to lower the risk of addiction. Ask your doctor or||
6238|094|H|pharmacist for more details.||
6238|095|H|   When used for an extended time, this medication may not work||
6238|096|H|as well and may require different dosing. Talk with your doctor||
6238|097|H|if this medication stops working well.||
6238|098|H|   Tell your doctor if your cough does not get better in 5 days.||
6238|099|H|Also, tell your doctor if your condition gets worse, or if you||
6238|100|H|have a headache that doesn't go away, fever, or rash. These may||
6238|101|H|be symptoms of a serious medical problem and should be checked by||
6238|102|H|a doctor.||
6238|103|B|||
6238|104|S|SIDE EFFECTS:  See also Warning section.||
6238|105|S|   Drowsiness, dizziness, headache, blurred vision, upset||
6238|106|S|stomach, nausea, constipation, or dry mouth/nose/throat may||
6238|107|S|occur. If any of these effects last or get worse, tell your||
6238|108|S|doctor or pharmacist promptly.||
6238|109|S|   To reduce the risk of dizziness and lightheadedness, get up||
6238|110|S|slowly when rising from a sitting or lying position.||
6238|111|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
6238|112|S|chips, chew (sugarless) gum, drink water, or use a saliva||
6238|113|S|substitute. This medication can dry up and thicken mucus in your||
6238|114|S|lungs, making it more difficult to breathe and clear your lungs.||
6238|115|S|To help prevent this effect, drink plenty of fluids unless||
6238|116|S|otherwise directed by your doctor.||
6238|117|S|   Remember that this medication has been prescribed because your||
6238|118|S|doctor has judged that the benefit to you is greater than the||
6238|119|S|risk of side effects. Many people using this medication do not||
6238|120|S|have serious side effects.||
6238|121|S|   This medication may raise your blood pressure. Check your||
6238|122|S|blood pressure regularly and tell your doctor if the results are||
6238|123|S|high.||
6238|124|S|   Tell your doctor right away if you have any serious side||
6238|125|S|effects, including: interrupted breathing during sleep (sleep||
6238|126|S|apnea), mental/mood changes (such as hallucinations), ringing in||
6238|127|S|the ears, shaking (tremors), trouble urinating, weakness, easy||
6238|128|S|bruising/bleeding, fast/slow/irregular heartbeat, trouble||
6238|129|S|swallowing.||
6238|130|S|   Get medical help right away if you have any very serious side||
6238|131|S|effects, including: seizure.||
6238|132|S|   This product may cause serious mental/mood changes and very||
6238|133|S|serious (rarely fatal) breathing problems. This product may||
6238|134|S|contain codeine or dihydrocodeine. Codeine and dihydrocodeine are||
6238|135|S|changed into strong opioid drugs (morphine or dihydromorphine) in||
6238|136|S|your body. In some people this happens faster and more completely||
6238|137|S|than usual, which increases the risk of very serious side||
6238|138|S|effects. Get medical help right away if you notice any of the||
6238|139|S|following: slow/shallow breathing, severe drowsiness/difficulty||
6238|140|S|waking up, confusion.||
6238|141|S|   A very serious allergic reaction to this drug is rare.||
6238|142|S|However, get medical help right away if you notice any symptoms||
6238|143|S|of a serious allergic reaction, including: rash, itching/swelling||
6238|144|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6238|145|S|breathing.||
6238|146|S|   This is not a complete list of possible side effects. If you||
6238|147|S|notice other effects not listed above, contact your doctor or||
6238|148|S|pharmacist.||
6238|149|S|   In the US -||
6238|150|S|   Call your doctor for medical advice about side effects. You||
6238|151|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6238|152|S|www.fda.gov/medwatch.||
6238|153|S|   In Canada - Call your doctor for medical advice about side||
6238|154|S|effects. You may report side effects to Health Canada at||
6238|155|S|1-866-234-2345.||
6238|156|B|||
6238|157|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
6238|158|P|pharmacist if you are allergic to any of its ingredients; or if||
6238|159|P|you have any other allergies. This product may contain inactive||
6238|160|P|ingredients, which can cause allergic reactions or other||
6238|161|P|problems. Talk to your pharmacist for more details.||
6238|162|P|   Before using this medication, tell your doctor or pharmacist||
6238|163|P|your medical history, especially of: abdominal problems (such as||
6238|164|P|chronic constipation, ileus, gallbladder disease, pancreatitis),||
6238|165|P|adrenal gland problem (such as Addison's disease), certain brain||
6238|166|P|disorders (such as head injury, tumor, increased intracranial||
6238|167|P|pressure), breathing problems (such as asthma, emphysema, sleep||
6238|168|P|apnea), diabetes, a certain eye problem (glaucoma), heart||
6238|169|P|problems, high blood pressure, kidney problems, liver disease,||
6238|170|P|mental/mood problems (such as depression, psychosis), seizures,||
6238|171|P|stomach/intestinal problems (such as ulcers, blockage), thyroid||
6238|172|P|problems (such as hyperthyroidism, hypothyroidism), urination||
6238|173|P|problems (such as trouble urinating due to enlarged prostate,||
6238|174|P|urinary retention), personal or family history of a substance use||
6238|175|P|disorder (such as overuse of or addiction to drugs/alcohol),||
6238|176|P|obesity.||
6238|177|P|   This drug may make you dizzy or drowsy or blur your vision.||
6238|178|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
6238|179|P|drowsy. Do not drive, use machinery, or do anything that needs||
6238|180|P|alertness or clear vision until you can do it safely. Avoid||
6238|181|P|alcoholic beverages. Talk to your doctor if you are using||
6238|182|P|marijuana (cannabis).||
6238|183|P|   This medication may contain sugar and/or alcohol. Caution is||
6238|184|P|advised if you have diabetes, alcohol dependence, or liver||
6238|185|P|disease. Ask your doctor or pharmacist about the safe use of this||
6238|186|P|product.||
6238|187|P|   Before having surgery, tell your doctor or dentist about all||
6238|188|P|the products you use (including prescription drugs,||
6238|189|P|nonprescription drugs, and herbal products).||
6238|190|P|   Older adults may be more sensitive to the side effects of this||
6238|191|P|drug, especially confusion, dizziness, drowsiness, and||
6238|192|P|slow/shallow breathing.||
6238|193|P|   Tell your doctor if you are pregnant or think you may be||
6238|194|P|pregnant. During pregnancy, this product is not recommended. It||
6238|195|P|may harm an unborn baby. Talk to your doctor about the risks and||
6238|196|P|benefits of this medication. See also Warning section.||
6238|197|P|   This product may pass into breast milk and may have||
6238|198|P|undesirable effects on a nursing infant (such as unusual||
6238|199|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
6238|200|P|limpness). Consult your doctor before breastfeeding.||
6238|201|B|||
6238|202|I|DRUG INTERACTIONS:  See also Warning section.||
6238|203|I|   Drug interactions may change how your medications work or||
6238|204|I|increase your risk for serious side effects. This document does||
6238|205|I|not contain all possible drug interactions. Keep a list of all||
6238|206|I|the products you use (including prescription/nonprescription||
6238|207|I|drugs and herbal products) and share it with your doctor and||
6238|208|I|pharmacist. Do not start, stop, or change the dosage of any||
6238|209|I|medicines without your doctor's approval.||
6238|210|I|   Some products that may interact with this drug include:||
6238|211|I|antihistamines applied to the skin (such as diphenhydramine||
6238|212|I|cream, ointment, spray), naltrexone, samidorphan.||
6238|213|I|   Taking MAO inhibitors with this medication may cause a serious||
6238|214|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
6238|215|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
6238|216|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
6238|217|I|selegiline, tranylcypromine) during treatment with this||
6238|218|I|medication. Most MAO inhibitors should also not be taken for two||
6238|219|I|weeks before treatment with this medication. Ask your doctor when||
6238|220|I|to start or stop taking this medication.||
6238|221|I|   The ingredients in this product may be available in many||
6238|222|I|prescription and nonprescription products. Check the labels on||
6238|223|I|all your medications carefully to make sure you are not taking||
6238|224|I|more than one product with the same ingredient(s). Consult your||
6238|225|I|pharmacist if you are unsure of the ingredients in any of your||
6238|226|I|medications.||
6238|227|I|   The risk of serious side effects (such as slow/shallow||
6238|228|I|breathing, severe drowsiness/dizziness) may be increased if this||
6238|229|I|medication is taken with other products that may also cause||
6238|230|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
6238|231|I|if you are taking other products such as other opioid pain or||
6238|232|I|cough relievers (such as codeine, hydrocodone), alcohol,||
6238|233|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
6238|234|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
6238|235|I|carisoprodol, cyclobenzaprine), or other antihistamines (such as||
6238|236|I|cetirizine, diphenhydramine).||
6238|237|I|   Check the labels on all your medicines (such as allergy or||
6238|238|I|cough-and-cold products) because they may contain ingredients||
6238|239|I|that cause drowsiness. Ask your pharmacist about using those||
6238|240|I|products safely.||
6238|241|I|   Other medications can affect the removal of this product from||
6238|242|I|your body, which may affect how this product works. Examples||
6238|243|I|include azole antifungals (such as ketoconazole), bupropion,||
6238|244|I|fluoxetine, macrolide antibiotics (such as erythromycin),||
6238|245|I|paroxetine, quinidine, rifamycins (such as rifabutin, rifampin),||
6238|246|I|ritonavir, certain drugs used to treat seizures (such as||
6238|247|I|carbamazepine, phenytoin), among others.||
6238|248|I|   This medication may interfere with certain lab tests (such as||
6238|249|I|5-HIAA levels, VMA levels, amylase/lipase levels, allergy skin||
6238|250|I|test), possibly causing false test results. Make sure lab||
6238|251|I|personnel and all your doctors know you use this drug.||
6238|252|B|||
6238|253|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6238|254|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6238|255|O|poison control center right away. US residents can call||
6238|256|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6238|257|O|Symptoms of overdose may include: confusion, flushing,||
6238|258|O|hallucinations, cold/clammy skin, slow/shallow breathing,||
6238|259|O|fast/slow/irregular heartbeat, seizures. In children, excitement||
6238|260|O|may occur first, and may be followed by loss of coordination,||
6238|261|O|drowsiness, coma, seizures, slow/shallow/noisy breathing.||
6238|262|B|||
6238|263|N|NOTES:  Do not share this medication with others. Sharing it is||
6238|264|N|against the law.||
6238|265|B|||
6238|266|D|MISSED DOSE:  If you are prescribed this medication on a regular||
6238|267|D|schedule and miss a dose, take it as soon as you remember. If it||
6238|268|D|is near the time of the next dose, skip the missed dose. Take||
6238|269|D|your next dose at the regular time. Do not double the dose to||
6238|270|D|catch up.||
6238|271|B|||
6238|272|R|STORAGE:  Store at room temperature away from light and moisture.||
6238|273|R|Do not store in the bathroom. Do not freeze. Keep all medications||
6238|274|R|away from children and pets.||
6238|275|R|   Do not flush medications down the toilet or pour them into a||
6238|276|R|drain unless instructed to do so. Properly discard this product||
6238|277|R|when it is expired or no longer needed. Consult your pharmacist||
6238|278|R|or local waste disposal company.||
6238|279|B|||
6238|280|A|Information last revised August 2025.||
6238|281|A|Copyright(c) 2025 First Databank, Inc.||
6238|282|B|||
6240|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6240|002|Z|does NOT have all possible information about this product. This||
6240|003|Z|information does not assure that this product is safe, effective,||
6240|004|Z|or appropriate for you. This information is not individual||
6240|005|Z|medical advice and does not substitute for the advice of your||
6240|006|Z|health care professional. Always ask your health care||
6240|007|Z|professional for complete information about this product and your||
6240|008|Z|specific health needs.||
6240|009|B|||
6240|010|T|AMOXICILLIN/CLAVULANIC ACID - ORAL||
6240|011|F|(a-MOX-i-SIL-in/KLAV-ue-LAN-ik AS-id)||
6240|012|B|||
6240|013|C|COMMON BRAND NAME(S): Augmentin||
6240|014|B|||
6240|015|U|USES:  Amoxicillin/clavulanic acid is a combination||
6240|016|U|penicillin-type antibiotic used to treat a wide variety of||
6240|017|U|bacterial infections. It works by stopping the growth of||
6240|018|U|bacteria.||
6240|019|U|   This antibiotic treats only bacterial infections. It will not||
6240|020|U|work for viral infections (such as common cold, flu). Using any||
6240|021|U|antibiotic when it is not needed can cause it to not work for||
6240|022|U|future infections.||
6240|023|B|||
6240|024|H|HOW TO USE:  Take this medication by mouth with a meal or snack||
6240|025|H|as directed by your doctor. Depending on your specific product,||
6240|026|H|this medication is usually taken every 8 or 12 hours.||
6240|027|H|   The dosage is based on your medical condition and response to||
6240|028|H|treatment.||
6240|029|H|   For the best effect, take this antibiotic at evenly spaced||
6240|030|H|times. To help you remember, take this medication at the same||
6240|031|H|time(s) every day.||
6240|032|H|   Continue to take this medication until the full prescribed||
6240|033|H|amount is finished, even if symptoms disappear after a few days.||
6240|034|H|Stopping the medication too early may result in a return of the||
6240|035|H|infection.||
6240|036|H|   Tell the doctor if your condition lasts or gets worse.||
6240|037|B|||
6240|038|S|SIDE EFFECTS:  Diarrhea, nausea, or vomiting may occur. If any of||
6240|039|S|these effects last or get worse, tell the doctor or pharmacist||
6240|040|S|promptly. Taking this medication with food will help to reduce||
6240|041|S|stomach upset.||
6240|042|S|   Remember that this medication has been prescribed because your||
6240|043|S|doctor has judged that the benefit to you is greater than the||
6240|044|S|risk of side effects. Many people using this medication do not||
6240|045|S|have serious side effects.||
6240|046|S|   Tell your doctor right away if you have any serious side||
6240|047|S|effects, including: signs of liver disease (such as||
6240|048|S|nausea/vomiting that doesn't stop, loss of appetite,||
6240|049|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
6240|050|S|bruising/bleeding, unusual tiredness.||
6240|051|S|   This medication may rarely cause a severe intestinal condition||
6240|052|S|due to a bacteria called C. difficile. This condition may occur||
6240|053|S|during treatment or weeks to months after treatment has stopped.||
6240|054|S|Tell your doctor right away if you develop: diarrhea that doesn't||
6240|055|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
6240|056|S|stool.||
6240|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
6240|058|S|products because they may make symptoms worse||
6240|059|S|   Use of this medication for prolonged or repeated periods may||
6240|060|S|result in oral thrush or a new yeast infection. Contact the||
6240|061|S|doctor if you notice white patches in your mouth, a change in||
6240|062|S|vaginal discharge or other new symptoms.||
6240|063|S|   A very serious allergic reaction to this drug is rare.||
6240|064|S|However, get medical help right away if you notice any symptoms||
6240|065|S|of a serious allergic reaction, including: fever that doesn't go||
6240|066|S|away, new or worsening lymph node swelling, rash,||
6240|067|S|itching/swelling (especially of the face/tongue/throat), severe||
6240|068|S|dizziness, trouble breathing.||
6240|069|S|   Amoxicillin can commonly cause a mild rash that is usually not||
6240|070|S|serious. However, you may not be able to tell it apart from a||
6240|071|S|rare rash that could be a sign of a severe allergic reaction. Get||
6240|072|S|medical help right away if you develop any rash.||
6240|073|S|   This is not a complete list of possible side effects. If you||
6240|074|S|notice other effects not listed above, contact the doctor or||
6240|075|S|pharmacist.||
6240|076|S|   In the US -||
6240|077|S|   Call your doctor for medical advice about side effects. You||
6240|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6240|079|S|www.fda.gov/medwatch.||
6240|080|S|   In Canada - Call your doctor for medical advice about side||
6240|081|S|effects. You may report side effects to Health Canada at||
6240|082|S|1-866-234-2345.||
6240|083|B|||
6240|084|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
6240|085|P|pharmacist if you are allergic to amoxicillin or clavulanic acid;||
6240|086|P|or to penicillin or cephalosporin antibiotics; or if you have any||
6240|087|P|other allergies. This product may contain inactive ingredients,||
6240|088|P|which can cause allergic reactions or other problems. Talk to||
6240|089|P|your pharmacist for more details.||
6240|090|P|   Before using this medication, tell the doctor or pharmacist||
6240|091|P|your medical history, especially of: liver disease (including||
6240|092|P|liver problems caused by previous use of amoxicillin/clavulanic||
6240|093|P|acid), kidney disease, a certain type of viral infection||
6240|094|P|(infectious mononucleosis).||
6240|095|P|   Before having surgery, tell your doctor or dentist about all||
6240|096|P|the products you use (including prescription drugs,||
6240|097|P|nonprescription drugs, and herbal products).||
6240|098|P|   This product may cause live bacterial vaccines (such as||
6240|099|P|typhoid vaccine) to not work well. Tell your health care||
6240|100|P|professional that you are using this medication before having any||
6240|101|P|immunizations/vaccinations.||
6240|102|P|   During pregnancy, this medication should be used only when||
6240|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
6240|104|P|   This medication passes into breast milk. Consult your doctor||
6240|105|P|before breastfeeding.||
6240|106|B|||
6240|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6240|108|I|medications work or increase your risk for serious side effects.||
6240|109|I|This document does not contain all possible drug interactions.||
6240|110|I|Keep a list of all the products you use (including||
6240|111|I|prescription/nonprescription drugs and herbal products) and share||
6240|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
6240|113|I|the dosage of any medicines without your doctor's approval.||
6240|114|I|   A product that may interact with this drug is: methotrexate.||
6240|115|I|   This medication may interfere with certain lab tests (such as||
6240|116|I|certain urine glucose tests), possibly causing false test||
6240|117|I|results. Make sure lab personnel and all your doctors know you||
6240|118|I|use this drug.||
6240|119|B|||
6240|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6240|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6240|122|O|poison control center right away. US residents can call||
6240|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6240|124|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
6240|125|O|severe vomiting, change in the amount of urine.||
6240|126|B|||
6240|127|N|NOTES:  Do not share this medication with others.||
6240|128|N|   This medication has been prescribed for your current condition||
6240|129|N|only. Do not use it later for another infection unless your||
6240|130|N|doctor tells you to.||
6240|131|N|   With long-term treatment, lab and/or medical tests (such as||
6240|132|N|kidney/liver function, complete blood counts) may be done while||
6240|133|N|you are taking this medication. Keep all medical and lab||
6240|134|N|appointments. Consult your doctor for more details.||
6240|135|B|||
6240|136|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6240|137|D|remember. If it is near the time of the next dose, skip the||
6240|138|D|missed dose. Take your next dose at the regular time. Do not||
6240|139|D|double the dose to catch up.||
6240|140|B|||
6240|141|R|STORAGE:  Store at room temperature away from light and moisture.||
6240|142|R|Do not store in the bathroom. Keep all medications away from||
6240|143|R|children and pets.||
6240|144|R|   Do not flush medications down the toilet or pour them into a||
6240|145|R|drain unless instructed to do so. Properly discard this product||
6240|146|R|when it is expired or no longer needed. Consult your pharmacist||
6240|147|R|or local waste disposal company.||
6240|148|B|||
6240|149|A|Information last revised May 2024.||
6240|150|A|Copyright(c) 2025 First Databank, Inc.||
6240|151|B|||
6241|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6241|002|Z|does NOT have all possible information about this product. This||
6241|003|Z|information does not assure that this product is safe, effective,||
6241|004|Z|or appropriate for you. This information is not individual||
6241|005|Z|medical advice and does not substitute for the advice of your||
6241|006|Z|health care professional. Always ask your health care||
6241|007|Z|professional for complete information about this product and your||
6241|008|Z|specific health needs.||
6241|009|B|||
6241|010|T|DICLOFENAC SUPPOSITORY - RECTAL||
6241|011|F|(dye-KLOE-fen-ak)||
6241|012|B|||
6241|013|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
6241|014|W|diclofenac) may rarely increase the risk for a heart attack or||
6241|015|W|stroke. This effect can happen at any time while using this drug||
6241|016|W|but is more likely if you use it for a long time. The risk may be||
6241|017|W|greater in older adults or if you have heart disease or increased||
6241|018|W|risk for heart disease (for example, due to smoking, family||
6241|019|W|history of heart disease, or conditions such as high blood||
6241|020|W|pressure or diabetes). Do not use this drug right before or after||
6241|021|W|heart bypass surgery (CABG).||
6241|022|W|   Also, this drug may rarely cause serious (rarely fatal)||
6241|023|W|bleeding from the stomach or intestines. This side effect can||
6241|024|W|occur without warning symptoms at any time while using||
6241|025|W|diclofenac. Older adults may be at higher risk for this effect.||
6241|026|W|(See also Precautions and Drug Interactions sections.)||
6241|027|W|   Stop using diclofenac and get medical help right away if you||
6241|028|W|notice any of the following rare but very serious side effects:||
6241|029|W|stomach/abdominal pain that doesn't go away, black/bloody stools,||
6241|030|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
6241|031|W|shortness of breath, unusual sweating, confusion, weakness on one||
6241|032|W|side of the body, sudden vision changes, trouble speaking.||
6241|033|W|   Talk with your doctor or pharmacist about the benefits and||
6241|034|W|risks of using this medication.||
6241|035|B|||
6241|036|U|USES:  See also Warning section.||
6241|037|U|   Diclofenac suppositories are used to relieve pain, swelling||
6241|038|U|(inflammation), and joint stiffness caused by arthritis.||
6241|039|U|Diclofenac does not cure arthritis, but reducing the symptoms||
6241|040|U|helps you do more of your normal daily activities. This||
6241|041|U|medication is known as a nonsteroidal anti-inflammatory drug||
6241|042|U|(NSAID).||
6241|043|U|   If you are treating a chronic condition such as arthritis, ask||
6241|044|U|your doctor about non-drug treatments and/or using other||
6241|045|U|medications to treat your pain.||
6241|046|B|||
6241|047|V|OTHER USES:  This section contains uses of this drug that are not||
6241|048|V|listed in the approved professional labeling for the drug but||
6241|049|V|that may be prescribed by your health care professional. Use this||
6241|050|V|drug for a condition that is listed in this section only if it||
6241|051|V|has been so prescribed by your health care professional.||
6241|052|V|   This drug may also be used for other painful conditions (such||
6241|053|V|as gout attacks). Consult your doctor or pharmacist for more||
6241|054|V|details.||
6241|055|B|||
6241|056|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6241|057|H|from your pharmacist before you start using diclofenac and each||
6241|058|H|time you get a refill. If you have any questions, ask your doctor||
6241|059|H|or pharmacist.||
6241|060|H|   Unwrap and insert 1 suppository into the rectum as directed by||
6241|061|H|your doctor. Lie down on your left side with right knee bent.||
6241|062|H|Gently push the suppository into the rectum with your finger.||
6241|063|H|Remain lying down for a few minutes, and avoid having a bowel||
6241|064|H|movement for an hour or longer so the drug will be absorbed. The||
6241|065|H|suppository is for use in the rectum only. Wash your hands after||
6241|066|H|use.||
6241|067|H|   The dosage is based on your medical condition and response to||
6241|068|H|treatment. Do not use more than 100 milligrams of diclofenac||
6241|069|H|(suppositories and/or tablets) in a 24-hour period. To reduce||
6241|070|H|your risk of stomach bleeding and other side effects, use this||
6241|071|H|medication at the lowest effective dose for the shortest possible||
6241|072|H|time. Do not increase your dose or use this drug more often or||
6241|073|H|for longer than prescribed. For ongoing conditions such as||
6241|074|H|arthritis, keep using it as directed. Discuss the risks and||
6241|075|H|benefits with your doctor or pharmacist.||
6241|076|H|   For certain conditions (such as arthritis), it may take up to||
6241|077|H|2 weeks of using this drug regularly until you get the full||
6241|078|H|benefit.||
6241|079|H|   If you are using this drug "as needed" (not on a regular||
6241|080|H|schedule), remember that pain medications work best if they are||
6241|081|H|used as the first signs of pain occur. If you wait until the pain||
6241|082|H|has worsened, the medication may not work as well.||
6241|083|H|   Tell your doctor if your condition gets worse or if your pain||
6241|084|H|is not controlled.||
6241|085|B|||
6241|086|S|SIDE EFFECTS:  See also Warning section.||
6241|087|S|   Headache, drowsiness, dizziness, loss of appetite, gas, or||
6241|088|S|irritation of the rectum may occur. If any of these effects last||
6241|089|S|or get worse, tell your doctor or pharmacist promptly.||
6241|090|S|   Remember that this medication has been prescribed because your||
6241|091|S|doctor has judged that the benefit to you is greater than the||
6241|092|S|risk of side effects. Many people using this medication do not||
6241|093|S|have serious side effects.||
6241|094|S|   This medication may raise your blood pressure. Check your||
6241|095|S|blood pressure regularly and tell your doctor if the results are||
6241|096|S|high.||
6241|097|S|   Tell your doctor right away if you have any serious side||
6241|098|S|effects, including: vision changes, hearing changes (such as||
6241|099|S|ringing in the ears), easy bruising/bleeding, mental/mood||
6241|100|S|changes, fast/pounding heartbeat, fainting, signs of kidney||
6241|101|S|problems (such as change in the amount of urine), symptoms of||
6241|102|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
6241|103|S|unusual/sudden weight gain).||
6241|104|S|   This drug may rarely cause serious (possibly fatal) liver||
6241|105|S|disease. Stop using diclofenac and get medical help right away if||
6241|106|S|you have any symptoms of liver damage, including: nausea/vomiting||
6241|107|S|that doesn't stop, loss of appetite, stomach/abdomen pain,||
6241|108|S|yellowing eyes/skin, dark urine.||
6241|109|S|   A very serious allergic reaction to this drug is rare.||
6241|110|S|However, get medical help right away if you notice any symptoms||
6241|111|S|of a serious allergic reaction, including: fever, swollen lymph||
6241|112|S|nodes, rash, itching/swelling (especially of the||
6241|113|S|face/tongue/throat), severe dizziness, trouble breathing.||
6241|114|S|   This is not a complete list of possible side effects. If you||
6241|115|S|notice other effects not listed above, contact your doctor or||
6241|116|S|pharmacist.||
6241|117|S|   In the US -||
6241|118|S|   Call your doctor for medical advice about side effects. You||
6241|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6241|120|S|www.fda.gov/medwatch.||
6241|121|S|   In Canada - Call your doctor for medical advice about side||
6241|122|S|effects. You may report side effects to Health Canada at||
6241|123|S|1-866-234-2345.||
6241|124|B|||
6241|125|P|PRECAUTIONS:  See also Warning section.||
6241|126|P|   Before using diclofenac, tell your doctor or pharmacist if you||
6241|127|P|are allergic to it; or to aspirin; or to other NSAIDs (such as||
6241|128|P|ibuprofen, naproxen, celecoxib); or if you have any other||
6241|129|P|allergies. This product may contain inactive ingredients, which||
6241|130|P|can cause allergic reactions or other problems. Talk to your||
6241|131|P|pharmacist for more details.||
6241|132|P|   Before using this medication, tell your doctor or pharmacist||
6241|133|P|your medical history, especially of: asthma (including a history||
6241|134|P|of worsening breathing after taking aspirin or other NSAIDs),||
6241|135|P|liver disease, stomach/intestine problems (such as bleeding,||
6241|136|P|ulcers), heart disease (such as previous heart attack), high||
6241|137|P|blood pressure, stroke, swelling (edema, fluid retention), blood||
6241|138|P|disorders (such as anemia), bleeding/clotting problems, growths||
6241|139|P|in the nose (nasal polyps), rectal/anal bleeding.||
6241|140|P|   Kidney problems can sometimes occur with the use of NSAID||
6241|141|P|medications, including diclofenac. Problems are more likely to||
6241|142|P|occur if you are dehydrated, have heart failure or kidney||
6241|143|P|disease, are an older adult, or if you take certain medications||
6241|144|P|(see also Drug Interactions section). Drink plenty of fluids as||
6241|145|P|directed by your doctor to prevent dehydration and tell your||
6241|146|P|doctor right away if you have a change in the amount of urine.||
6241|147|P|   Before having surgery, tell your doctor or dentist about all||
6241|148|P|the products you use (including prescription drugs,||
6241|149|P|nonprescription drugs, and herbal products).||
6241|150|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6241|151|P|can make you more dizzy. Do not drive, use machinery, or do||
6241|152|P|anything that needs alertness until you can do it safely. Talk to||
6241|153|P|your doctor if you are using marijuana (cannabis).||
6241|154|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
6241|155|P|and tobacco, especially when combined with this medicine,||
6241|156|P|increases your risk for stomach bleeding. Limit alcohol and stop||
6241|157|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
6241|158|P|may safely drink.||
6241|159|P|   This medication may make you more sensitive to the sun. Limit||
6241|160|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
6241|161|P|sunscreen and wear protective clothing when outdoors. Tell your||
6241|162|P|doctor right away if you get sunburned or have skin||
6241|163|P|blisters/redness.||
6241|164|P|   Older adults may be at greater risk for stomach/intestinal||
6241|165|P|bleeding, kidney problems, heart attack, and stroke while using||
6241|166|P|this drug.||
6241|167|P|   Before using this medication, women of childbearing age should||
6241|168|P|talk with their doctor(s) about the benefits and risks. Tell your||
6241|169|P|doctor if you are pregnant or if you plan to become pregnant.||
6241|170|P|This medication may harm an unborn baby and cause problems with||
6241|171|P|normal labor/delivery. It is not recommended for use in pregnancy||
6241|172|P|from 20 weeks until delivery. If your doctor decides that you||
6241|173|P|need to use this medication between 20 and 30 weeks of pregnancy,||
6241|174|P|you should use the lowest effective dose for the shortest||
6241|175|P|possible time. You should not use this medication after 30 weeks||
6241|176|P|of pregnancy.||
6241|177|P|   This medication passes into breast milk, but is unlikely to||
6241|178|P|harm a nursing infant. Consult your doctor before breastfeeding.||
6241|179|B|||
6241|180|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6241|181|I|medications work or increase your risk for serious side effects.||
6241|182|I|This document does not contain all possible drug interactions.||
6241|183|I|Keep a list of all the products you use (including||
6241|184|I|prescription/nonprescription drugs and herbal products) and share||
6241|185|I|it with your doctor and pharmacist. Do not start, stop, or change||
6241|186|I|the dosage of any medicines without your doctor's approval.||
6241|187|I|   Some products that may interact with this drug include:||
6241|188|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
6241|189|I|angiotensin II receptor blockers (such as losartan, valsartan),||
6241|190|I|cidofovir, corticosteroids (such as dexamethasone, prednisone),||
6241|191|I|lithium, methotrexate, "water pills" (diuretics such as||
6241|192|I|furosemide).||
6241|193|I|   This medication may increase the risk of bleeding when used||
6241|194|I|with other drugs that also may cause bleeding. Examples include||
6241|195|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
6241|196|I|dabigatran/enoxaparin/warfarin, among others.||
6241|197|I|   Check all prescription and nonprescription medicine labels||
6241|198|I|carefully since many medications contain pain relievers/fever||
6241|199|I|reducers (aspirin, NSAIDs such as celecoxib, ibuprofen,||
6241|200|I|ketorolac). These drugs are similar to diclofenac and may||
6241|201|I|increase your risk of side effects if taken together. However, if||
6241|202|I|your doctor has told you to take low-dose aspirin to prevent||
6241|203|I|heart attack or stroke (usually 81-162 milligrams a day), you||
6241|204|I|should keep taking the aspirin unless your doctor tells you not||
6241|205|I|to. Ask your doctor or pharmacist for more details.||
6241|206|B|||
6241|207|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6241|208|O|has overdosed and has serious symptoms such as passing out or||
6241|209|O|trouble breathing, call 911. Otherwise, call a poison control||
6241|210|O|center right away. US residents can call 1-800-222-1222. Canada||
6241|211|O|residents can call 1-844-764-7669. Symptoms of overdose may||
6241|212|O|include: severe stomach pain, slow/shallow breathing, seizures,||
6241|213|O|change in the amount of urine.||
6241|214|B|||
6241|215|N|NOTES:  Do not share this medication with others.||
6241|216|N|   This medication has been prescribed for your current condition||
6241|217|N|only. Do not use it later for another pain unless your doctor||
6241|218|N|directs you to do so. A different medication may be necessary in||
6241|219|N|that case.||
6241|220|N|   Lab and/or medical tests (such as complete blood count,||
6241|221|N|liver/kidney function, blood pressure) should be done while you||
6241|222|N|are using this medication. Keep all medical and lab appointments.||
6241|223|N|Consult your doctor for more details.||
6241|224|N|   Lifestyle changes (such as weight loss if needed,||
6241|225|N|strengthening/conditioning exercises) may help improve your||
6241|226|N|flexibility and joint function. Consult your doctor for specific||
6241|227|N|instructions.||
6241|228|B|||
6241|229|D|MISSED DOSE:  If you are prescribed this drug on a regular||
6241|230|D|schedule (not just "as needed") and you miss a dose, use it as||
6241|231|D|soon as you remember. If it is near the time of the next dose,||
6241|232|D|skip the missed dose. Use your next dose at the regular time. Do||
6241|233|D|not double the dose to catch up.||
6241|234|B|||
6241|235|R|STORAGE:  Store at room temperature away from light and moisture.||
6241|236|R|Keep all medications away from children and pets.||
6241|237|R|   Do not flush medications down the toilet or pour them into a||
6241|238|R|drain unless instructed to do so. Properly discard this product||
6241|239|R|when it is expired or no longer needed. Consult your pharmacist||
6241|240|R|or local waste disposal company.||
6241|241|B|||
6241|242|A|Information last revised November 2025.||
6241|243|A|Copyright(c) 2025 First Databank, Inc.||
6241|244|B|||
6244|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6244|002|Z|does NOT have all possible information about this product. This||
6244|003|Z|information does not assure that this product is safe, effective,||
6244|004|Z|or appropriate for you. This information is not individual||
6244|005|Z|medical advice and does not substitute for the advice of your||
6244|006|Z|health care professional. Always ask your health care||
6244|007|Z|professional for complete information about this product and your||
6244|008|Z|specific health needs.||
6244|009|B|||
6244|010|T|LORAZEPAM - INJECTION||
6244|011|F|(lor-AZ-e-pam)||
6244|012|B|||
6244|013|C|COMMON BRAND NAME(S): Ativan||
6244|014|B|||
6244|015|W|WARNING:  Lorazepam has a risk for abuse and addiction, which can||
6244|016|W|lead to overdose and death. Using this medication with alcohol or||
6244|017|W|other drugs that can cause drowsiness or breathing problems||
6244|018|W|(especially opioid medications such as codeine, hydrocodone) may||
6244|019|W|cause very serious side effects, including death. To lower your||
6244|020|W|risk, your doctor should have you use the smallest dose of||
6244|021|W|lorazepam that works, and use it for the shortest possible time.||
6244|022|W|Be sure you know how to use lorazepam and what other drugs you||
6244|023|W|should avoid taking with it. See also Drug Interactions section.||
6244|024|W|Get medical help right away if any of these very serious side||
6244|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
6244|026|W|severe drowsiness/dizziness, difficulty waking up.||
6244|027|W|   Suddenly stopping this medication may cause serious (possibly||
6244|028|W|fatal) withdrawal, especially if you have used it for a long time||
6244|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
6244|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
6244|031|W|you have any withdrawal symptoms such as headaches, trouble||
6244|032|W|sleeping, restlessness, hallucinations/confusion, depression,||
6244|033|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
6244|034|W|to months.||
6244|035|B|||
6244|036|U|USES:  This medication is used to treat serious seizures that do||
6244|037|U|not stop (status epilepticus). It is also used before surgeries||
6244|038|U|or procedures to cause drowsiness, decrease anxiety, and cause||
6244|039|U|forgetfulness about the procedure or surgery.||
6244|040|U|   Lorazepam belongs to a class of medications called||
6244|041|U|benzodiazepines, which produce a calming effect on the brain and||
6244|042|U|nerves (central nervous system). It is thought to work by||
6244|043|U|increasing the effect of a certain natural chemical (GABA) in the||
6244|044|U|brain.||
6244|045|B|||
6244|046|V|OTHER USES:  This section contains uses of this drug that are not||
6244|047|V|listed in the approved professional labeling for the drug but||
6244|048|V|that may be prescribed by your health care professional. Use this||
6244|049|V|drug for a condition that is listed in this section only if it||
6244|050|V|has been so prescribed by your health care professional.||
6244|051|V|   This drug may also be used to cause drowsiness in people who||
6244|052|V|need a tube and machine to help with breathing (intubated) or to||
6244|053|V|reduce the risk of nausea and vomiting in people on chemotherapy.||
6244|054|V|It may also be used for a mental/mood disorder (delirium).||
6244|055|B|||
6244|056|H|HOW TO USE:  See also Warning section.||
6244|057|H|   This medication is given by injection into a vein or muscle as||
6244|058|H|directed by your doctor. The dosage is based on your medical||
6244|059|H|condition, age, and response to treatment.||
6244|060|H|   If you are giving this medication to yourself at home, learn||
6244|061|H|all preparation and usage instructions from your health care||
6244|062|H|professional. Before using, check this product for particles or||
6244|063|H|discoloration. If either is present, do not use the liquid. Learn||
6244|064|H|how to store and discard medical supplies safely.||
6244|065|H|   Do not suddenly stop using this drug without consulting your||
6244|066|H|doctor. Some conditions may become worse when this drug is||
6244|067|H|abruptly stopped. Your dose may need to be gradually decreased.||
6244|068|H|   When this medication is used for a long time, it may not work||
6244|069|H|as well. Talk with your doctor if this medication stops working||
6244|070|H|well.||
6244|071|H|   Though it helps many people, this medication may sometimes||
6244|072|H|cause addiction. This risk may be higher if you have a substance||
6244|073|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
6244|074|H|Take this medication exactly as prescribed to lower the risk of||
6244|075|H|addiction. Ask your doctor or pharmacist for more details.||
6244|076|H|   Tell your doctor if your condition lasts or gets worse.||
6244|077|B|||
6244|078|S|SIDE EFFECTS:  See also Warning section.||
6244|079|S|   Drowsiness, dizziness, blurred vision,||
6244|080|S|pain/burning/swelling/redness at the injection site, or||
6244|081|S|unsteadiness may occur. If any of these effects last or get||
6244|082|S|worse, tell your doctor or pharmacist promptly.||
6244|083|S|   Remember that this medication has been prescribed because your||
6244|084|S|doctor has judged that the benefit to you is greater than the||
6244|085|S|risk of side effects. Many people using this medication do not||
6244|086|S|have serious side effects.||
6244|087|S|   Tell your doctor right away if you have any serious side||
6244|088|S|effects, including: mental/mood changes (such as hallucinations,||
6244|089|S|agitation, confusion), muscle weakness.||
6244|090|S|   Get medical help right away if you have any very serious side||
6244|091|S|effects, including: slow/shallow breathing, seizures.||
6244|092|S|   This medication can rarely have the opposite of its usual||
6244|093|S|calming effect. Symptoms of this opposite effect may include||
6244|094|S|agitation, irritability, violent behavior, confusion,||
6244|095|S|restlessness, excitement, and talking more than normal. Tell your||
6244|096|S|doctor right away if you notice any of these effects.||
6244|097|S|   A very serious allergic reaction to this drug is rare.||
6244|098|S|However, get medical help right away if you notice any symptoms||
6244|099|S|of a serious allergic reaction, including: rash, itching/swelling||
6244|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6244|101|S|breathing.||
6244|102|S|   This is not a complete list of possible side effects. If you||
6244|103|S|notice other effects not listed above, contact your doctor or||
6244|104|S|pharmacist.||
6244|105|S|   In the US -||
6244|106|S|   Call your doctor for medical advice about side effects. You||
6244|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6244|108|S|www.fda.gov/medwatch.||
6244|109|S|   In Canada - Call your doctor for medical advice about side||
6244|110|S|effects. You may report side effects to Health Canada at||
6244|111|S|1-866-234-2345.||
6244|112|B|||
6244|113|P|PRECAUTIONS:  Before using lorazepam, tell your doctor or||
6244|114|P|pharmacist if you are allergic to it; or to other benzodiazepines||
6244|115|P|(such as alprazolam, clonazepam, diazepam); or if you have any||
6244|116|P|other allergies. This product may contain inactive ingredients,||
6244|117|P|which can cause allergic reactions or other problems. Talk to||
6244|118|P|your pharmacist for more details.||
6244|119|P|   Before using this medication, tell your doctor your medical||
6244|120|P|history, especially of: glaucoma, heart disease, kidney disease,||
6244|121|P|liver disease, personal or family history of a substance use||
6244|122|P|disorder (such as overuse of or addiction to drugs/alcohol),||
6244|123|P|mental/mood disorders (such as depression, psychosis), breathing||
6244|124|P|problems (such as asthma, chronic obstructive pulmonary||
6244|125|P|disease-COPD, sleep apnea).||
6244|126|P|   Before having surgery, tell your doctor or dentist about all||
6244|127|P|the products you use (including prescription drugs,||
6244|128|P|nonprescription drugs, and herbal products).||
6244|129|P|   This drug may make you dizzy or drowsy or blur your vision.||
6244|130|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
6244|131|P|drowsy. For at least 8 hours after receiving this drug, you||
6244|132|P|should not get out of bed without help. Do not drive, use||
6244|133|P|machinery, or do anything that needs alertness or clear vision||
6244|134|P|until the effects of the medication wear off (at least 24 hours).||
6244|135|P|Avoid alcoholic beverages. Talk to your doctor if you are using||
6244|136|P|marijuana (cannabis).||
6244|137|P|   Older adults may be more sensitive to the side effects of this||
6244|138|P|drug, especially loss of coordination and drowsiness. Loss of||
6244|139|P|coordination and drowsiness may increase the risk of falling.||
6244|140|P|Also, lorazepam may have the opposite of its usual calming effect||
6244|141|P|in older adults (see also Side Effects section).||
6244|142|P|   This drug may have the opposite of its usual calming effect in||
6244|143|P|children, causing restlessness, shaking, or mental/mood changes||
6244|144|P|(such as agitation, hallucinations).||
6244|145|P|   Infants and children younger than 3 years using anesthesia or||
6244|146|P|drugs for sedation (including lorazepam) for procedures/surgeries||
6244|147|P|may be at risk for slower brain growth. Talk to the doctor about||
6244|148|P|the risks and benefits of this medication.||
6244|149|P|   Tell your doctor if you are pregnant or plan to become||
6244|150|P|pregnant. You should not become pregnant while using lorazepam.||
6244|151|P|Lorazepam may harm an unborn baby. Newborn babies of mothers who||
6244|152|P|receive this medication late in pregnancy may have symptoms such||
6244|153|P|as slow/shallow breathing, nonstop crying, shaking, or trouble||
6244|154|P|feeding. If you become pregnant, talk to your doctor right away||
6244|155|P|about the risks and benefits of this medication.||
6244|156|P|   This drug passes into breast milk. Consult your doctor before||
6244|157|P|breastfeeding.||
6244|158|B|||
6244|159|I|DRUG INTERACTIONS:  See also Warning section.||
6244|160|I|   Drug interactions may change how your medications work or||
6244|161|I|increase your risk for serious side effects. This document does||
6244|162|I|not contain all possible drug interactions. Keep a list of all||
6244|163|I|the products you use (including prescription/nonprescription||
6244|164|I|drugs and herbal products) and share it with your doctor and||
6244|165|I|pharmacist. Do not start, stop, or change the dosage of any||
6244|166|I|medicines without your doctor's approval.||
6244|167|I|   Some products that may interact with this drug include:||
6244|168|I|clozapine, haloperidol, kava, loxapine, orlistat, sodium oxybate||
6244|169|I|(also known as gamma hydroxybutyrate or GHB).||
6244|170|I|   The risk of serious side effects (such as slow/shallow||
6244|171|I|breathing, severe drowsiness/dizziness) may be increased if this||
6244|172|I|medication is used with other products that may also cause||
6244|173|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
6244|174|I|if you are taking other products such as opioid pain or cough||
6244|175|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6244|176|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
6244|177|I|diazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6244|178|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6244|179|I|diphenhydramine).||
6244|180|I|   Check the labels on all your medicines (such as allergy or||
6244|181|I|cough-and-cold products) because they may contain ingredients||
6244|182|I|that cause drowsiness. Ask your pharmacist about using those||
6244|183|I|products safely.||
6244|184|B|||
6244|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6244|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6244|187|O|poison control center right away. US residents can call||
6244|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6244|189|O|Symptoms of overdose may include: extreme drowsiness/dizziness,||
6244|190|O|confusion, extreme tiredness, unsteadiness, loss of||
6244|191|O|consciousness.||
6244|192|B|||
6244|193|N|NOTES:  Do not share this medication with others. Sharing it is||
6244|194|N|against the law.||
6244|195|B|||
6244|196|D|MISSED DOSE:  It is important to get each dose of this medication||
6244|197|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6244|198|D|right away for a new dosing schedule. Do not double the dose to||
6244|199|D|catch up.||
6244|200|B|||
6244|201|R|STORAGE:  Store in the refrigerator away from light or as||
6244|202|R|directed by your pharmacist. Do not freeze. Keep all medications||
6244|203|R|away from children and pets.||
6244|204|R|   Do not flush medications down the toilet or pour them into a||
6244|205|R|drain unless instructed to do so. Properly discard this product||
6244|206|R|when it is expired or no longer needed. Consult your pharmacist||
6244|207|R|or local waste disposal company.||
6244|208|B|||
6244|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
6244|210|M|medical emergency. For information about enrolling in MedicAlert,||
6244|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6244|212|B|||
6244|213|A|Information last revised May 2025.||
6244|214|A|Copyright(c) 2025 First Databank, Inc.||
6244|215|B|||
6245|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6245|002|Z|does NOT have all possible information about this product. This||
6245|003|Z|information does not assure that this product is safe, effective,||
6245|004|Z|or appropriate for you. This information is not individual||
6245|005|Z|medical advice and does not substitute for the advice of your||
6245|006|Z|health care professional. Always ask your health care||
6245|007|Z|professional for complete information about this product and your||
6245|008|Z|specific health needs.||
6245|009|B|||
6245|010|T|BUDESONIDE SUSPENSION FOR NEBULIZER - INHALATION||
6245|011|F|(bue-DES-oh-nide)||
6245|012|B|||
6245|013|C|COMMON BRAND NAME(S): Pulmicort||
6245|014|B|||
6245|015|U|USES:  Budesonide is used to control and prevent symptoms||
6245|016|U|(wheezing and shortness of breath) caused by asthma. This||
6245|017|U|medication belongs to a class of drugs known as corticosteroids.||
6245|018|U|It works directly in the lungs to make breathing easier by||
6245|019|U|reducing the irritation and swelling of the airways.||
6245|020|U|   This medication must be used regularly to be effective. It||
6245|021|U|does not work right away and should not be used to relieve sudden||
6245|022|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
6245|023|U|inhaler as prescribed.||
6245|024|B|||
6245|025|V|OTHER USES:  This section contains uses of this drug that are not||
6245|026|V|listed in the approved professional labeling for the drug but||
6245|027|V|that may be prescribed by your health care professional. Use this||
6245|028|V|drug for a condition that is listed in this section only if it||
6245|029|V|has been so prescribed by your health care professional.||
6245|030|V|   This drug may also be used for lung diseases such as||
6245|031|V|bronchitis and emphysema. It may also be used for a certain||
6245|032|V|esophagus problem (eosinophilic esophagitis).||
6245|033|B|||
6245|034|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
6245|035|H|your pharmacist before you start using this medication and each||
6245|036|H|time you get a refill. Follow the illustrated directions for the||
6245|037|H|proper use of this medication. Make sure you understand how to||
6245|038|H|operate the breathing machine (compressed air jet nebulizer with||
6245|039|H|face mask or mouthpiece) and how to properly clean it to prevent||
6245|040|H|infections. If you have any questions, ask your doctor,||
6245|041|H|pharmacist, or respiratory therapist.||
6245|042|H|   Do not use this medication in an ultrasonic nebulizer. Do not||
6245|043|H|mix budesonide suspension with other medications in the||
6245|044|H|nebulizer. A parent or other responsible adult should supervise a||
6245|045|H|child who is using this machine. If you have any questions, ask||
6245|046|H|your health care professional.||
6245|047|H|   Shake the container gently before use. The dosage is based on||
6245|048|H|your medical condition and response to treatment. This medication||
6245|049|H|comes in different strengths. Check that you are using the||
6245|050|H|correct strength.||
6245|051|H|   Inhale this medication by mouth as directed by your doctor,||
6245|052|H|usually once or twice daily. While inhaling this medication,||
6245|053|H|breathe calmly and deeply until the mist stops, usually over 5 to||
6245|054|H|10 minutes. Avoid getting the medication in the eyes.||
6245|055|H|   To prevent dry mouth, hoarseness, and oral yeast infections,||
6245|056|H|gargle, rinse your mouth with water and spit out after each use.||
6245|057|H|Do not swallow the rinse water. Also, wash your face where the||
6245|058|H|face mask/mouthpiece has touched your skin to prevent skin||
6245|059|H|reactions and irritation.||
6245|060|H|   Use this medication regularly in order to get the most benefit||
6245|061|H|from it. To help you remember, use it at the same time(s) each||
6245|062|H|day. Do not increase your dose, use it more often, or stop using||
6245|063|H|this medication without first consulting your doctor.||
6245|064|H|   Learn which of your inhalers/medications you should use every||
6245|065|H|day (controller drugs) and which you should use if your breathing||
6245|066|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
6245|067|H|time what you should do if you have new or worsening cough or||
6245|068|H|shortness of breath, wheezing, increased sputum, worsening peak||
6245|069|H|flow meter readings, waking up at night with trouble breathing,||
6245|070|H|if you use your quick-relief inhaler more often (more than 2 days||
6245|071|H|a week), or if your quick-relief inhaler does not seem to be||
6245|072|H|working well. Learn when you can treat sudden breathing problems||
6245|073|H|by yourself and when you must get medical help right away.||
6245|074|H|   If you are regularly taking a different corticosteroid by||
6245|075|H|mouth (such as prednisone), you should not stop taking it unless||
6245|076|H|directed by your doctor. Some conditions (such as asthma,||
6245|077|H|allergies) may become worse when the drug is suddenly stopped. If||
6245|078|H|you suddenly stop taking the drug, you may also have withdrawal||
6245|079|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
6245|080|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
6245|081|H|doctor may slowly lower the dose of your old medication after you||
6245|082|H|begin using budesonide. Tell your doctor or pharmacist right away||
6245|083|H|if you have withdrawal. See also Precautions section.||
6245|084|H|   You may notice a benefit within 2 to 8 days of starting this||
6245|085|H|drug. It may take up to 4 to 6 weeks of regular use before the||
6245|086|H|full benefit of this drug takes effect. Tell your doctor if your||
6245|087|H|symptoms do not get better or if they get worse.||
6245|088|B|||
6245|089|S|SIDE EFFECTS:  See also Precautions section.||
6245|090|S|   Dry/irritated throat, hoarseness, voice changes, bad taste in||
6245|091|S|the mouth, runny nose, or nosebleeds may occur. If any of these||
6245|092|S|effects last or get worse, tell your doctor or pharmacist||
6245|093|S|promptly.||
6245|094|S|   Remember that this medication has been prescribed because your||
6245|095|S|doctor has judged that the benefit to you is greater than the||
6245|096|S|risk of side effects. Many people using this medication do not||
6245|097|S|have serious side effects.||
6245|098|S|   Rarely, this medication may cause sudden breathing||
6245|099|S|problems/asthma right after you use it. If this occurs, use your||
6245|100|S|quick-relief inhaler and get medical help right away.||
6245|101|S|   Because this drug works by weakening the immune system, it may||
6245|102|S|lower your ability to fight infections. This may make you more||
6245|103|S|likely to get a serious (rarely fatal) infection or make any||
6245|104|S|infection you have worse. Tell your doctor right away if you have||
6245|105|S|any signs of infection (such as sore throat that doesn't go away,||
6245|106|S|fever, chills). Use of this medication for prolonged or repeated||
6245|107|S|periods may result in oral thrush (yeast infection). Contact your||
6245|108|S|doctor if you notice white patches in your mouth or on your||
6245|109|S|tongue.||
6245|110|S|   Tell your doctor right away if you have any serious side||
6245|111|S|effects, including: unusual tiredness, vision problems, easy||
6245|112|S|bruising/bleeding, puffy face, unusual hair growth, mental/mood||
6245|113|S|changes (such as depression, mood swings, agitation), muscle||
6245|114|S|weakness/pain, thinning skin, slow wound healing, increased||
6245|115|S|thirst/urination.||
6245|116|S|   A very serious allergic reaction to this product is rare.||
6245|117|S|However, get medical help right away if you notice any symptoms||
6245|118|S|of a serious allergic reaction, including: rash, itching/swelling||
6245|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6245|120|S|breathing.||
6245|121|S|   This is not a complete list of possible side effects. If you||
6245|122|S|notice other effects not listed above, contact your doctor or||
6245|123|S|pharmacist.||
6245|124|S|   In the US -||
6245|125|S|   Call your doctor for medical advice about side effects. You||
6245|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6245|127|S|www.fda.gov/medwatch.||
6245|128|S|   In Canada - Call your doctor for medical advice about side||
6245|129|S|effects. You may report side effects to Health Canada at||
6245|130|S|1-866-234-2345.||
6245|131|B|||
6245|132|P|PRECAUTIONS:  Before using budesonide, tell your doctor if you||
6245|133|P|are allergic to it; or if you have any other allergies. This||
6245|134|P|product may contain inactive ingredients, which can cause||
6245|135|P|allergic reactions or other problems. Talk to your pharmacist for||
6245|136|P|more details.||
6245|137|P|   Before using this medication, tell your doctor or pharmacist||
6245|138|P|your medical history, especially of: eye disease (such as||
6245|139|P|cataracts, glaucoma), high blood pressure, liver disease, thyroid||
6245|140|P|problems, diabetes, stomach/intestinal problems (such as||
6245|141|P|diverticulitis, ulcer), bone loss (osteoporosis), current/past||
6245|142|P|infections (such as tuberculosis, positive tuberculosis test,||
6245|143|P|herpes, fungal), bleeding problems, mental/mood conditions (such||
6245|144|P|as psychosis, anxiety, depression).||
6245|145|P|   If you have switched from a corticosteroid taken by mouth||
6245|146|P|(such as prednisone tablets) to this inhaler within the past 12||
6245|147|P|months, or if you have been using this product in||
6245|148|P|higher-than-usual doses for a long time, it may be more difficult||
6245|149|P|for your body to respond to physical stress. Before having||
6245|150|P|surgery or emergency treatment, or if you get a serious||
6245|151|P|illness/injury, tell your doctor or dentist that you are using||
6245|152|P|this medication or have used a corticosteroid taken by mouth||
6245|153|P|within the past 12 months. Tell your doctor right away if you||
6245|154|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
6245|155|P|card or medical ID bracelet that says you use (or have used)||
6245|156|P|corticosteroid medications.||
6245|157|P|   Before having surgery, tell your doctor or dentist about all||
6245|158|P|the products you use (including prescription drugs,||
6245|159|P|nonprescription drugs, and herbal products).||
6245|160|P|   This medication may mask signs of infection. It can make you||
6245|161|P|more likely to get infections or may make current infections||
6245|162|P|worse. Stay away from anyone who has an infection that may easily||
6245|163|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
6245|164|P|doctor if you have been exposed to an infection or for more||
6245|165|P|details.||
6245|166|P|   Tell your health care professional that you are using||
6245|167|P|budesonide before having any immunizations/vaccinations. Avoid||
6245|168|P|contact with people who have recently received live vaccines||
6245|169|P|(such as flu vaccine inhaled through the nose).||
6245|170|P|   This medication may temporarily slow down a child's growth if||
6245|171|P|used for a long time. However, poorly controlled asthma can also||
6245|172|P|slow down growth. See the doctor regularly so your child's height||
6245|173|P|can be checked.||
6245|174|P|   During pregnancy, this medication should be used only when||
6245|175|P|clearly needed. Discuss the risks and benefits with your doctor.||
6245|176|P|   This medication passes into breast milk. Consult your doctor||
6245|177|P|before breastfeeding.||
6245|178|B|||
6245|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6245|180|I|medications work or increase your risk for serious side effects.||
6245|181|I|This document does not contain all possible drug interactions.||
6245|182|I|Keep a list of all the products you use (including||
6245|183|I|prescription/nonprescription drugs and herbal products) and share||
6245|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
6245|185|I|the dosage of any medicines without your doctor's approval.||
6245|186|I|   Some products that may interact with this drug include:||
6245|187|I|aldesleukin, desmopressin, mifepristone.||
6245|188|I|   This medication may interfere with certain lab tests (such as||
6245|189|I|skin tests), possibly causing false test results. Make sure lab||
6245|190|I|personnel and all your doctors know you use this drug.||
6245|191|B|||
6245|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6245|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6245|194|O|poison control center right away. US residents can call||
6245|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6245|196|B|||
6245|197|N|NOTES:  Do not share this medication with others.||
6245|198|N|   Lab and/or medical tests (such as cortisol levels, bone||
6245|199|N|density tests, eye exams, height/weight measurements) should be||
6245|200|N|done while you are using this medication. Keep all medical and||
6245|201|N|lab appointments. Consult your doctor for more details.||
6245|202|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
6245|203|N|mold that can worsen breathing problems. Because the flu virus||
6245|204|N|can also worsen breathing problems, ask your doctor or pharmacist||
6245|205|N|if you should have a flu shot every year.||
6245|206|N|   This medication may cause bone loss (osteoporosis) in adults||
6245|207|N|when used for a long time. Lifestyle changes that may help reduce||
6245|208|N|the risk of bone problems include doing weight-bearing exercise,||
6245|209|N|stopping smoking, limiting alcohol, and getting enough calcium||
6245|210|N|and vitamin D. Talk to your doctor for more details.||
6245|211|B|||
6245|212|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6245|213|D|If it is near the time of the next dose, skip the missed dose.||
6245|214|D|Use your next dose at the regular time. Do not double the dose to||
6245|215|D|catch up.||
6245|216|B|||
6245|217|R|STORAGE:  Keep the ampules upright in the original foil package||
6245|218|R|to protect from light. Different brands of this medication have||
6245|219|R|different storage needs. Check the product package for||
6245|220|R|instructions on how to store your brand, or ask your pharmacist.||
6245|221|R|Keep all medications away from children and pets.||
6245|222|R|   Do not flush medications down the toilet or pour them into a||
6245|223|R|drain unless instructed to do so. Properly discard this product||
6245|224|R|when it is expired or no longer needed. Consult your pharmacist||
6245|225|R|or local waste disposal company.||
6245|226|B|||
6245|227|M|MEDICAL ALERT:  Your condition can cause complications in a||
6245|228|M|medical emergency. For information about enrolling in MedicAlert,||
6245|229|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6245|230|B|||
6245|231|A|Information last revised September 2025.||
6245|232|A|Copyright(c) 2025 First Databank, Inc.||
6245|233|B|||
6246|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6246|002|Z|does NOT have all possible information about this product. This||
6246|003|Z|information does not assure that this product is safe, effective,||
6246|004|Z|or appropriate for you. This information is not individual||
6246|005|Z|medical advice and does not substitute for the advice of your||
6246|006|Z|health care professional. Always ask your health care||
6246|007|Z|professional for complete information about this product and your||
6246|008|Z|specific health needs.||
6246|009|B|||
6246|010|T|ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT - INJECTION||
6246|011|F|(AN-tye-HEE-moe-FIL-ik FAK-tor, ree-KOM-bi-nant)||
6246|012|B|||
6246|013|C|COMMON BRAND NAME(S): Advate, Adynovate, Esperoct, Jivi,||
6246|014|C|Kogenate, Obizur, Recombinate||
6246|015|B|||
6246|016|U|USES:  This medication is used to control and prevent bleeding||
6246|017|U|episodes in people with low levels of factor VIII (hemophilia A).||
6246|018|U|It is also used in these patients before surgery to prevent||
6246|019|U|bleeding. People with low factor VIII levels are at risk for||
6246|020|U|bleeding longer after an injury/surgery and for bleeding inside||
6246|021|U|the body (especially into the joints and muscles). This product||
6246|022|U|contains a man-made form of factor VIII, also called||
6246|023|U|antihemophilic factor. This product is used to temporarily||
6246|024|U|replace the missing factor VIII, a protein (clotting factor) that||
6246|025|U|is normally in the blood, so that the blood can clot and the||
6246|026|U|bleeding can stop.||
6246|027|U|   This medication should not be used to treat von Willebrand||
6246|028|U|disease.||
6246|029|B|||
6246|030|H|HOW TO USE:  This medication is given by injection into a vein as||
6246|031|H|directed by your doctor. The medication may need to be given more||
6246|032|H|slowly over a longer time depending on your dose and how you||
6246|033|H|respond to it.||
6246|034|H|   After first receiving this medication in a hemophilia||
6246|035|H|treatment center or hospital, some patients may be able to give||
6246|036|H|this medication to themselves at home. If your doctor directs you||
6246|037|H|to give this medication at home, read the Patient Information||
6246|038|H|Leaflet and Instructions for Use if available from your||
6246|039|H|pharmacist before you start using this medication and each time||
6246|040|H|you get a refill. Learn all preparation and usage instructions in||
6246|041|H|the product package. Learn how to store and discard needles and||
6246|042|H|medical supplies safely. If you have any questions, ask your||
6246|043|H|health care professional.||
6246|044|H|   If the medication and the solution used to mix it were||
6246|045|H|refrigerated, bring both to room temperature before mixing. After||
6246|046|H|adding the solution to the powder, gently swirl the mixture to||
6246|047|H|completely dissolve the powder. Do not shake. Before using, check||
6246|048|H|this product for particles or discoloration. If either is||
6246|049|H|present, do not use the liquid. Use right away according to the||
6246|050|H|product instructions.||
6246|051|H|   The dosage is based on your medical condition, age, weight,||
6246|052|H|blood test results, and response to treatment. Follow your||
6246|053|H|doctor's instructions closely.||
6246|054|H|   Tell your doctor if your condition does not get better or if||
6246|055|H|it gets worse.||
6246|056|B|||
6246|057|S|SIDE EFFECTS:  Flushing of the face, headache, nausea, and fast||
6246|058|S|heartbeat may sometimes occur and can be lessened by giving this||
6246|059|S|medication more slowly. Burning/redness/irritation at the||
6246|060|S|injection site, fever, and chills may also occur. If any of these||
6246|061|S|effects last or get worse, tell your doctor or pharmacist||
6246|062|S|promptly.||
6246|063|S|   Remember that this medication has been prescribed because your||
6246|064|S|doctor has judged that the benefit to you is greater than the||
6246|065|S|risk of side effects. Many people using this medication do not||
6246|066|S|have serious side effects.||
6246|067|S|   A very serious allergic reaction to this drug is rare.||
6246|068|S|However, get medical help right away if you notice any symptoms||
6246|069|S|of a serious allergic reaction, including: rash, itching/swelling||
6246|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6246|071|S|breathing, chest discomfort/tightness.||
6246|072|S|   This is not a complete list of possible side effects. If you||
6246|073|S|notice other effects not listed above, contact your doctor or||
6246|074|S|pharmacist.||
6246|075|S|   In the US -||
6246|076|S|   Call your doctor for medical advice about side effects. You||
6246|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6246|078|S|www.fda.gov/medwatch.||
6246|079|S|   In Canada - Call your doctor for medical advice about side||
6246|080|S|effects. You may report side effects to Health Canada at||
6246|081|S|1-866-234-2345.||
6246|082|B|||
6246|083|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6246|084|P|pharmacist if you are allergic to any antihemophilic factor||
6246|085|P|(factor VIII) products; or if you have any other allergies. Some||
6246|086|P|brands may also contain polyethylene glycol (PEG), or inactive||
6246|087|P|ingredients (such as natural rubber/latex), which can cause||
6246|088|P|allergic reactions or other problems. Talk to your pharmacist for||
6246|089|P|more details.||
6246|090|P|   Before using this medication, tell your doctor or pharmacist||
6246|091|P|your medical history, especially of: a certain type of hemophilia||
6246|092|P|(congenital hemophilia A with inhibitors).||
6246|093|P|   Manufacturers of some brands of this medication recommend that||
6246|094|P|you monitor your heartbeat during treatment. If your heart starts||
6246|095|P|to beat faster, it is recommended that you give this medication||
6246|096|P|more slowly or temporarily stop the infusion until your heart||
6246|097|P|rate returns to normal. Consult your doctor for more details.||
6246|098|P|   During pregnancy, this medication should be used only when||
6246|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
6246|100|P|   It is unknown if this drug passes into breast milk. Consult||
6246|101|P|your doctor before breastfeeding.||
6246|102|B|||
6246|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6246|104|I|medications work or increase your risk for serious side effects.||
6246|105|I|This document does not contain all possible drug interactions.||
6246|106|I|Keep a list of all the products you use (including||
6246|107|I|prescription/nonprescription drugs and herbal products) and share||
6246|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
6246|109|I|the dosage of any medicines without your doctor's approval.||
6246|110|B|||
6246|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6246|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6246|113|O|poison control center right away. US residents can call||
6246|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6246|115|B|||
6246|116|N|NOTES:  Do not share this medication with others.||
6246|117|N|   Lab tests (such as factor VIII levels) should be done while||
6246|118|N|you are using this medication. Keep all medical and lab||
6246|119|N|appointments. Consult your doctor for more details.||
6246|120|B|||
6246|121|D|MISSED DOSE:  It is important to follow the dosing schedule as||
6246|122|D|directed by your doctor. If you miss a dose, ask your doctor or||
6246|123|D|pharmacist right away for a new dosing schedule. Do not double||
6246|124|D|the dose to catch up.||
6246|125|B|||
6246|126|R|STORAGE:  Different brands of this medication have different||
6246|127|R|storage needs. Check the product package for instructions on how||
6246|128|R|to store your brand, or ask your pharmacist. Keep all medications||
6246|129|R|away from children and pets.||
6246|130|R|   Do not flush medications down the toilet or pour them into a||
6246|131|R|drain unless instructed to do so. Properly discard this product||
6246|132|R|when it is expired or no longer needed. Consult your pharmacist||
6246|133|R|or local waste disposal company.||
6246|134|B|||
6246|135|M|MEDICAL ALERT:  Your condition can cause complications in a||
6246|136|M|medical emergency. For information about enrolling in MedicAlert,||
6246|137|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6246|138|B|||
6246|139|A|Information last revised January 2025.||
6246|140|A|Copyright(c) 2025 First Databank, Inc.||
6246|141|B|||
6252|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6252|002|Z|does NOT have all possible information about this product. This||
6252|003|Z|information does not assure that this product is safe, effective,||
6252|004|Z|or appropriate for you. This information is not individual||
6252|005|Z|medical advice and does not substitute for the advice of your||
6252|006|Z|health care professional. Always ask your health care||
6252|007|Z|professional for complete information about this product and your||
6252|008|Z|specific health needs.||
6252|009|B|||
6252|010|T|BENZOCAINE SPRAY - MUCOUS MEMBRANE||
6252|011|F|(BEN-zoe-kane)||
6252|012|B|||
6252|013|C|COMMON BRAND NAME(S): HurriCaine||
6252|014|B|||
6252|015|U|USES:  Benzocaine spray is used to numb the lining of the mouth||
6252|016|U|and throat before certain medical procedures (such as||
6252|017|U|intubation). It is also used to temporarily relieve pain from||
6252|018|U|minor mouth/throat problems (such as sore throat, canker sores,||
6252|019|U|minor dental procedures, mouth/gum injury). It is also used to||
6252|020|U|decrease pain while dentures are being fitted and while your gums||
6252|021|U|are adjusting to the dentures. It should not be used long-term to||
6252|022|U|decrease pain from poorly fitting dentures. It is a local||
6252|023|U|anesthetic that starts to numb the lining of the mouth and throat||
6252|024|U|15 to 30 seconds after application and lasts about 15 minutes.||
6252|025|U|   Do not use this product for children younger than 2 years due||
6252|026|U|to risk of serious side effects. Ask your doctor for more||
6252|027|U|details.||
6252|028|B|||
6252|029|H|HOW TO USE:  Use this product as directed. Follow all directions||
6252|030|H|on the product package. If you have any questions, ask your||
6252|031|H|doctor or pharmacist.||
6252|032|H|   This medication is usually sprayed within the mouth by a||
6252|033|H|health care professional immediately before your procedure.||
6252|034|H|   Some products require shaking before use. If you are using||
6252|035|H|this medication for self-treating a painful sore throat or||
6252|036|H|mouth/gum problems, hold the product so the spray tube is 1 to 2||
6252|037|H|inches (2.5 to 5.1 centimeters) away from the area to be sprayed.||
6252|038|H|Spray for half a second. Allow the medication to stay in the||
6252|039|H|painful area for at least 1 minute, then spit out. You may repeat||
6252|040|H|the spray once if needed. Do not use more than 2 sprays at once||
6252|041|H|or use more than 4 times a day unless directed by your doctor.||
6252|042|H|   Avoid spraying in or near the eyes. Do not breathe in the||
6252|043|H|spray.||
6252|044|H|   Do not use large amounts or apply this more often than||
6252|045|H|directed because the chance for serious side effects (including||
6252|046|H|rarely fatal methemoglobinemia) will increase.||
6252|047|H|   This medication numbs the mouth and throat. This effect may||
6252|048|H|make swallowing difficult and increase your risk of choking or||
6252|049|H|swallowing the wrong way. Do not eat or chew gum for 1 hour after||
6252|050|H|this product is used or until your mouth/throat is no longer||
6252|051|H|numb. It is especially important to make sure children do not eat||
6252|052|H|or chew gum for at least 1 hour after use of this medication. Be||
6252|053|H|careful not to accidentally bite your tongue or mouth.||
6252|054|H|   Stop using this medication and tell your doctor if your sore||
6252|055|H|throat is severe, if it lasts more than 2 days, or if you have a||
6252|056|H|fever, headache, rash, swelling, nausea, or vomiting. You may||
6252|057|H|have a serious medical problem that may require different||
6252|058|H|treatment. If sore mouth symptoms last more than 7 days, stop||
6252|059|H|using this medication and call your doctor or dentist. If your||
6252|060|H|condition lasts or gets worse, or if you think you may have a||
6252|061|H|serious medical problem, get medical help right away.||
6252|062|B|||
6252|063|S|SIDE EFFECTS:  Slight burning, tingling, or stinging may occur.||
6252|064|S|If any of these effects last or get worse, tell your doctor or||
6252|065|S|pharmacist promptly.||
6252|066|S|   If your doctor has directed you to use this medication,||
6252|067|S|remember that your doctor has judged that the benefit to you is||
6252|068|S|greater than the risk of side effects. Many people using this||
6252|069|S|medication do not have serious side effects.||
6252|070|S|   This medication has rarely caused a very serious (possibly||
6252|071|S|fatal) blood disorder (methemoglobinemia). This effect is more||
6252|072|S|likely if you have breathing problems, certain diseases of the||
6252|073|S|blood, or if you smoke (see also Precautions section). The||
6252|074|S|symptoms of this disorder may occur within minutes to a couple of||
6252|075|S|hours after using this medication. Stop using this medication and||
6252|076|S|get medical help right away if you develop any symptoms of||
6252|077|S|methemoglobinemia, including: pale/bluish/gray skin, unusual||
6252|078|S|tiredness, shortness of breath, fast heartbeat, dizziness,||
6252|079|S|headache, confusion.||
6252|080|S|   A very serious allergic reaction to this drug is rare.||
6252|081|S|However, get medical help right away if you notice any symptoms||
6252|082|S|of a serious allergic reaction, including: rash, itching/swelling||
6252|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6252|084|S|breathing.||
6252|085|S|   This is not a complete list of possible side effects. If you||
6252|086|S|notice other effects not listed above, contact your doctor or||
6252|087|S|pharmacist.||
6252|088|S|   In the US -||
6252|089|S|   Call your doctor for medical advice about side effects. You||
6252|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6252|091|S|www.fda.gov/medwatch.||
6252|092|S|   In Canada - Call your doctor for medical advice about side||
6252|093|S|effects. You may report side effects to Health Canada at||
6252|094|S|1-866-234-2345.||
6252|095|B|||
6252|096|P|PRECAUTIONS:  Before using benzocaine, tell your doctor or||
6252|097|P|pharmacist if you are allergic to it; or to other "caine"||
6252|098|P|anesthetics (such as procaine) or if you have any other||
6252|099|P|allergies. This product may contain inactive ingredients, which||
6252|100|P|can cause allergic reactions or other problems. Talk to your||
6252|101|P|pharmacist for more details.||
6252|102|P|   If you have any of the following health problems, consult your||
6252|103|P|doctor or pharmacist before using this product: certain blood||
6252|104|P|disorders (G6PD deficiency, pyruvate kinase deficiency,||
6252|105|P|hemoglobin-M disease, NADH-methemoglobin reductase deficiency),||
6252|106|P|breathing problems (such as asthma, bronchitis, emphysema,||
6252|107|P|smoking history), heart disease.||
6252|108|P|   During pregnancy, this product should be used only when||
6252|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
6252|110|P|   It is unknown if this product passes into breast milk. Consult||
6252|111|P|your doctor before breastfeeding.||
6252|112|B|||
6252|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6252|114|I|medications work or increase your risk for serious side effects.||
6252|115|I|This document does not contain all possible drug interactions.||
6252|116|I|Keep a list of all the products you use (including||
6252|117|I|prescription/nonprescription drugs and herbal products) and share||
6252|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
6252|119|I|the dosage of any medicines without your doctor's approval.||
6252|120|B|||
6252|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6252|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6252|123|O|poison control center right away. US residents can call||
6252|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6252|125|O|Symptoms of overdose may include: severe dizziness, severe||
6252|126|O|drowsiness, seizures, slow/irregular heartbeat.||
6252|127|B|||
6252|128|N|NOTES:  Keep all medical and lab appointments.||
6252|129|B|||
6252|130|D|MISSED DOSE:  Not applicable.||
6252|131|B|||
6252|132|R|STORAGE:  Different brands of this medication have different||
6252|133|R|storage needs. Check the product package for instructions on how||
6252|134|R|to store your brand, or ask your pharmacist. Keep all medications||
6252|135|R|away from children and pets.||
6252|136|R|   Do not flush medications down the toilet or pour them into a||
6252|137|R|drain unless instructed to do so. Properly discard this product||
6252|138|R|when it is expired or no longer needed. Consult your pharmacist||
6252|139|R|or local waste disposal company.||
6252|140|B|||
6252|141|A|Information last revised May 2024.||
6252|142|A|Copyright(c) 2025 First Databank, Inc.||
6252|143|B|||
6253|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6253|002|Z|does NOT have all possible information about this product. This||
6253|003|Z|information does not assure that this product is safe, effective,||
6253|004|Z|or appropriate for you. This information is not individual||
6253|005|Z|medical advice and does not substitute for the advice of your||
6253|006|Z|health care professional. Always ask your health care||
6253|007|Z|professional for complete information about this product and your||
6253|008|Z|specific health needs.||
6253|009|B|||
6253|010|T|BETAMETHASONE/SALICYLIC ACID - TOPICAL||
6253|011|F|(BAY-ta-METH-ah-sone/SAL-i-SIL-ik AS-id)||
6253|012|B|||
6253|013|U|USES:  This medication is used to treat dry, scaly skin||
6253|014|U|conditions. Betamethasone is a corticosteroid that helps to||
6253|015|U|reduce swelling, itching, and redness. Salicylic acid belongs to||
6253|016|U|the same class of drugs as aspirin (salicylates). It causes the||
6253|017|U|skin to shed dead cells from its top layer by increasing the||
6253|018|U|amount of moisture in the skin and dissolving the substance that||
6253|019|U|acts as "cement" between the cells. This effect helps to shed the||
6253|020|U|skin cells, soften the top layer of skin, and decrease scaling||
6253|021|U|and dryness.||
6253|022|B|||
6253|023|H|HOW TO USE:  Use this medication on the skin only. Clean and dry||
6253|024|H|the area to be treated. Apply a thin layer of the medication to||
6253|025|H|the affected area and gently rub in as directed by your doctor,||
6253|026|H|usually twice daily (in the morning and evening). Wash your hands||
6253|027|H|after using unless you are using this medication to treat the||
6253|028|H|hands. Do not wrap, cover, or bandage the area unless directed to||
6253|029|H|do so by your doctor.||
6253|030|H|   Do not apply the medication in or around the eyes, nose,||
6253|031|H|mouth, genitals, or anus. If you do get the medication in those||
6253|032|H|areas, flush with plenty of water.||
6253|033|H|   Do not apply more often or use longer than prescribed because||
6253|034|H|doing so may increase the risk of side effects.||
6253|035|H|   Use this medication regularly to get the most benefit from it.||
6253|036|H|To help you remember, use it at the same times each day.||
6253|037|H|   Tell your doctor if your condition gets worse or if it does||
6253|038|H|not get better after 1 week.||
6253|039|B|||
6253|040|S|SIDE EFFECTS:  Burning, irritation, or skin peeling may occur. If||
6253|041|S|any of these effects last or get worse, tell your doctor or||
6253|042|S|pharmacist promptly.||
6253|043|S|   Remember that this medication has been prescribed because your||
6253|044|S|doctor has judged that the benefit to you is greater than the||
6253|045|S|risk of side effects. Many people using this medication do not||
6253|046|S|have serious side effects.||
6253|047|S|   Tell your doctor right away if you have any serious side||
6253|048|S|effects, including: skin thinning/discoloration, extreme hair||
6253|049|S|growth, acne, small red bumps on the skin (folliculitis), stretch||
6253|050|S|marks.||
6253|051|S|   Rarely, it is possible this medication will be absorbed from||
6253|052|S|the skin into the bloodstream. This can lead to side effects of||
6253|053|S|too much corticosteroid. These side effects are more likely in||
6253|054|S|children, and in people who use this medication for a long time||
6253|055|S|or over large areas of the skin. Tell your doctor right away if||
6253|056|S|any of the following side effects occur: unusual/extreme||
6253|057|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
6253|058|S|thirst/urination, vision problems.||
6253|059|S|   A very serious allergic reaction to this drug is rare.||
6253|060|S|However, get medical help right away if you notice any symptoms||
6253|061|S|of a serious allergic reaction, including: rash, itching/swelling||
6253|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6253|063|S|breathing.||
6253|064|S|   This is not a complete list of possible side effects. If you||
6253|065|S|notice other effects not listed above, contact your doctor or||
6253|066|S|pharmacist.||
6253|067|S|   In the US -||
6253|068|S|   Call your doctor for medical advice about side effects. You||
6253|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6253|070|S|www.fda.gov/medwatch.||
6253|071|S|   In Canada - Call your doctor for medical advice about side||
6253|072|S|effects. You may report side effects to Health Canada at||
6253|073|S|1-866-234-2345.||
6253|074|B|||
6253|075|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6253|076|P|pharmacist if you are allergic to betamethasone or salicylic||
6253|077|P|acid; or to other corticosteroids (such as hydrocortisone); or to||
6253|078|P|aspirin or other salicylates (such as magnesium salicylate); or||
6253|079|P|if you have any other allergies. This product may contain||
6253|080|P|inactive ingredients, which can cause allergic reactions or other||
6253|081|P|problems. Talk to your pharmacist for more details.||
6253|082|P|   Before using this medication, tell your doctor or pharmacist||
6253|083|P|your medical history, especially of: kidney disease, liver||
6253|084|P|disease, poor blood circulation, immune system problems, certain||
6253|085|P|infections (including viral infections such as||
6253|086|P|vaccinia/chickenpox/herpes simplex, fungal infections,||
6253|087|P|tuberculosis of the skin).||
6253|088|P|   Rarely, using corticosteroid medications for a long time or||
6253|089|P|over large areas of skin can make it more difficult for your body||
6253|090|P|to respond to physical stress. Before having surgery or emergency||
6253|091|P|treatment, or if you get a serious illness/injury, tell your||
6253|092|P|doctor or dentist that you are using this medication or have used||
6253|093|P|this medication within the past few months.||
6253|094|P|   Though it is unlikely, this medication may temporarily slow||
6253|095|P|down a child's growth if used for a long time. See the doctor||
6253|096|P|regularly so your child's height can be checked.||
6253|097|P|   This medication is similar to aspirin. Children and teenagers||
6253|098|P|younger than 18 years should not use this medication if they have||
6253|099|P|chickenpox, flu, or any undiagnosed illness, or if they have just||
6253|100|P|been given a live virus vaccine, without first consulting a||
6253|101|P|doctor about Reye's syndrome, a rare but serious illness.||
6253|102|P|   During pregnancy, this product should be used only when||
6253|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
6253|104|P|   It is unknown if this product passes into breast milk. Consult||
6253|105|P|your doctor before breastfeeding.||
6253|106|B|||
6253|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6253|108|I|medications work or increase your risk for serious side effects.||
6253|109|I|This document does not contain all possible drug interactions.||
6253|110|I|Keep a list of all the products you use (such as||
6253|111|I|prescription/nonprescription drugs and herbal products) and share||
6253|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
6253|113|I|the dosage of any medicines without your doctor's approval.||
6253|114|B|||
6253|115|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6253|116|O|has overdosed and has serious symptoms such as passing out or||
6253|117|O|trouble breathing, call 911. Otherwise, call a poison control||
6253|118|O|center right away. US residents can call 1-800-222-1222. Canada||
6253|119|O|residents can call 1-844-764-7669. Symptoms of overdose may||
6253|120|O|include: nausea, vomiting, dizziness, hearing changes (such as||
6253|121|O|loss of hearing, ringing in the ears).||
6253|122|B|||
6253|123|N|NOTES:  Do not share this medication with others.||
6253|124|N|   This medication has been prescribed for your current condition||
6253|125|N|only. Do not use it later for another skin condition unless told||
6253|126|N|to do so by your doctor. A different medication may be necessary||
6253|127|N|in that case.||
6253|128|N|   Lab and/or medical tests (such as adrenal gland function) may||
6253|129|N|be done while you are using this medication, especially if you||
6253|130|N|use this drug for an extended period of time or apply it over||
6253|131|N|large areas of the body. Keep all medical and lab appointments.||
6253|132|N|Consult your doctor for more details.||
6253|133|B|||
6253|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6253|135|D|If it is near the time of the next dose, skip the missed dose.||
6253|136|D|Use your next dose at the regular time. Do not double the dose to||
6253|137|D|catch up.||
6253|138|B|||
6253|139|R|STORAGE:  Store in the refrigerator or at room temperature. Do||
6253|140|R|not store or use the lotion form of this medication near an open||
6253|141|R|flame or heat. Keep all medications away from children and pets.||
6253|142|R|   Do not flush medications down the toilet or pour them into a||
6253|143|R|drain unless instructed to do so. Properly discard this product||
6253|144|R|when it is expired or no longer needed. Consult your pharmacist||
6253|145|R|or local waste disposal company.||
6253|146|B|||
6253|147|A|Information last revised November 2024.||
6253|148|A|Copyright(c) 2025 First Databank, Inc.||
6253|149|B|||
6262|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6262|002|Z|does NOT have all possible information about this product. This||
6262|003|Z|information does not assure that this product is safe, effective,||
6262|004|Z|or appropriate for you. This information is not individual||
6262|005|Z|medical advice and does not substitute for the advice of your||
6262|006|Z|health care professional. Always ask your health care||
6262|007|Z|professional for complete information about this product and your||
6262|008|Z|specific health needs.||
6262|009|B|||
6262|010|T|BUTENAFINE CREAM - TOPICAL||
6262|011|F|(bue-TEN-a-feen)||
6262|012|B|||
6262|013|C|COMMON BRAND NAME(S): Lotrimin Ultra, Mentax||
6262|014|B|||
6262|015|U|USES:  This medication is used to treat a variety of fungal skin||
6262|016|U|infections such as ringworm, athlete's foot, and jock itch. This||
6262|017|U|medication is also used to treat a skin condition known as||
6262|018|U|pityriasis (tinea versicolor), a fungal infection that causes a||
6262|019|U|lightening or darkening of the skin of the neck, chest, arms, or||
6262|020|U|legs. Butenafine is an antifungal that works by preventing the||
6262|021|U|growth of fungus.||
6262|022|U|   Do not use this medication for the treatment of fungal nail||
6262|023|U|infections.||
6262|024|B|||
6262|025|H|HOW TO USE:  Use this medication on the skin only. Clean and||
6262|026|H|thoroughly dry the area to be treated. Apply a thin layer of the||
6262|027|H|medication to and around the affected area and gently rub in,||
6262|028|H|usually 1 to 2 times daily as directed on the product package. If||
6262|029|H|you have any questions, ask your doctor or pharmacist. If your||
6262|030|H|doctor has prescribed this medication to you, then use as||
6262|031|H|directed. Wash your hands after using unless the area to be||
6262|032|H|treated includes the hands. Do not wrap, cover, or bandage the||
6262|033|H|area unless directed to do so by your doctor.||
6262|034|H|   Do not apply the medication in the eyes, nose, or mouth,||
6262|035|H|inside the vagina, or on the scalp. If you do get the medication||
6262|036|H|in those areas, flush with plenty of water.||
6262|037|H|   The dosage and length of treatment depends on the type of||
6262|038|H|infection being treated.||
6262|039|H|   Do not apply more often or use longer than directed. This may||
6262|040|H|increase the risk of side effects.||
6262|041|H|   Use this medication regularly to get the most benefit from it.||
6262|042|H|To help you remember, use it at the same time(s) each day.||
6262|043|H|   Continue to use this medication until the full treatment||
6262|044|H|period is finished, even if symptoms disappear after a few days.||
6262|045|H|Stopping the medication too early may result in a return of the||
6262|046|H|infection.||
6262|047|H|   Tell your doctor if your condition gets worse or if it does||
6262|048|H|not get better after the treatment period.||
6262|049|B|||
6262|050|S|SIDE EFFECTS:  Burning, irritation, redness, or itching at the||
6262|051|S|application site may occur. If any of these effects last or get||
6262|052|S|worse, tell your doctor or pharmacist promptly.||
6262|053|S|   If your doctor has prescribed this medication, remember that||
6262|054|S|your doctor has judged that the benefit to you is greater than||
6262|055|S|the risk of side effects. Many people using this medication do||
6262|056|S|not have serious side effects.||
6262|057|S|   Tell your doctor right away if you have any serious side||
6262|058|S|effects, including: blistering/swelling/oozing at the application||
6262|059|S|site.||
6262|060|S|   A very serious allergic reaction to this drug is rare.||
6262|061|S|However, get medical help right away if you notice any symptoms||
6262|062|S|of a serious allergic reaction, including: rash, itching/swelling||
6262|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6262|064|S|breathing.||
6262|065|S|   This is not a complete list of possible side effects. If you||
6262|066|S|notice other effects not listed above, contact your doctor or||
6262|067|S|pharmacist.||
6262|068|S|   In the US -||
6262|069|S|   Call your doctor for medical advice about side effects. You||
6262|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6262|071|S|www.fda.gov/medwatch.||
6262|072|S|   In Canada - Call your doctor for medical advice about side||
6262|073|S|effects. You may report side effects to Health Canada at||
6262|074|S|1-866-234-2345.||
6262|075|B|||
6262|076|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6262|077|P|pharmacist if you are allergic to butenafine; or to allylamine||
6262|078|P|antifungals (such as naftifine, terbinafine); or if you have any||
6262|079|P|other allergies. This product may contain inactive ingredients,||
6262|080|P|which can cause allergic reactions or other problems. Talk to||
6262|081|P|your pharmacist for more details.||
6262|082|P|   Before using this medication, tell your doctor or pharmacist||
6262|083|P|your medical history, especially of: athlete's foot on the||
6262|084|P|bottom/side of the foot.||
6262|085|P|   During pregnancy, this medication should be used only when||
6262|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
6262|087|P|   It is unknown if this drug passes into breast milk. Consult||
6262|088|P|your doctor before breastfeeding.||
6262|089|B|||
6262|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6262|091|I|medications work or increase your risk for serious side effects.||
6262|092|I|This document does not contain all possible drug interactions.||
6262|093|I|Keep a list of all the products you use (including||
6262|094|I|prescription/nonprescription drugs and herbal products) and share||
6262|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
6262|096|I|the dosage of any medicines without your doctor's approval.||
6262|097|B|||
6262|098|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6262|099|O|has overdosed and has serious symptoms such as passing out or||
6262|100|O|trouble breathing, call 911. Otherwise, call a poison control||
6262|101|O|center right away. US residents can call 1-800-222-1222. Canada||
6262|102|O|residents can call 1-844-764-7669.||
6262|103|B|||
6262|104|N|NOTES:  Do not share this medication with others.||
6262|105|N|   If your doctor has directed you to use this medication, use it||
6262|106|N|for your current condition only. Do not use it later for another||
6262|107|N|infection unless your doctor tells you to.||
6262|108|N|   If you are treating athlete's foot, make sure to wear||
6262|109|N|well-fitting, ventilated shoes. Also, change shoes and socks at||
6262|110|N|least once daily.||
6262|111|N|   When this medication is used to treat pityriasis, your normal||
6262|112|N|skin color may not return right away. It may take several months||
6262|113|N|after treatment is completed for your natural skin color to||
6262|114|N|return.||
6262|115|B|||
6262|116|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6262|117|D|If it is near the time of the next dose, skip the missed dose.||
6262|118|D|Use your next dose at the regular time. Do not double the dose to||
6262|119|D|catch up.||
6262|120|B|||
6262|121|R|STORAGE:  Store at room temperature. Keep all medications away||
6262|122|R|from children and pets.||
6262|123|R|   Do not flush medications down the toilet or pour them into a||
6262|124|R|drain unless instructed to do so. Properly discard this product||
6262|125|R|when it is expired or no longer needed. Consult your pharmacist||
6262|126|R|or local waste disposal company.||
6262|127|B|||
6262|128|A|Information last revised November 2024.||
6262|129|A|Copyright(c) 2025 First Databank, Inc.||
6262|130|B|||
6268|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6268|002|Z|does NOT have all possible information about this product. This||
6268|003|Z|information does not assure that this product is safe, effective,||
6268|004|Z|or appropriate for you. This information is not individual||
6268|005|Z|medical advice and does not substitute for the advice of your||
6268|006|Z|health care professional. Always ask your health care||
6268|007|Z|professional for complete information about this product and your||
6268|008|Z|specific health needs.||
6268|009|B|||
6268|010|T|NEVIRAPINE - ORAL||
6268|011|F|(ne-VIR-a-peen)||
6268|012|B|||
6268|013|C|COMMON BRAND NAME(S): Viramune||
6268|014|B|||
6268|015|W|WARNING:  Rarely, nevirapine has caused severe (sometimes fatal)||
6268|016|W|liver problems. Get medical help right away if you develop||
6268|017|W|symptoms of liver problems such as nausea that doesn't go away,||
6268|018|W|loss of appetite, vomiting, stomach/abdominal pain, dark urine,||
6268|019|W|pale stools, yellowing eyes/skin, unusual tiredness, rash.||
6268|020|W|   Rarely, nevirapine has also caused serious (sometimes fatal)||
6268|021|W|skin/allergic reactions. Get medical help right away if you have||
6268|022|W|any signs of skin/allergic reactions, including sore throat that||
6268|023|W|doesn't go away, swollen lymph nodes, rash,||
6268|024|W|itching/swelling/redness (especially of the eyes/face), blisters,||
6268|025|W|fever, unusual tiredness, mouth sores, severe dizziness, trouble||
6268|026|W|breathing, signs of kidney problems (such as change in the amount||
6268|027|W|of urine), muscle pain/tenderness/weakness, joint pain.||
6268|028|W|   Women are at increased risk for developing these severe||
6268|029|W|reactions. To help decrease the risk of skin/allergic reactions||
6268|030|W|in all patients, nevirapine is started at a lower dose for the||
6268|031|W|first 14 days. Also, people with higher T-cell counts at the||
6268|032|W|start of nevirapine treatment are at greater risk for liver||
6268|033|W|problems. Nevirapine is usually only started if the T-cell count||
6268|034|W|is fewer than 250 in women or fewer than 400 in men.||
6268|035|W|   Keep all medical and lab appointments so your doctor can||
6268|036|W|monitor how you are responding to nevirapine. The risk of these||
6268|037|W|serious side effects is high in the first 18 weeks and highest||
6268|038|W|during the first 6 weeks of nevirapine treatment. However, these||
6268|039|W|side effects may occur at any time while taking this medication.||
6268|040|W|   If you have stopped taking nevirapine because of liver||
6268|041|W|problems or skin/allergic reactions, you must never take any form||
6268|042|W|of nevirapine again. Tell all of your doctors and pharmacists if||
6268|043|W|you have ever stopped taking nevirapine because of these types of||
6268|044|W|reactions.||
6268|045|B|||
6268|046|U|USES:  This drug is used with other HIV medications to help||
6268|047|U|control HIV infection. It helps to decrease the amount of HIV in||
6268|048|U|your body so your immune system can work better. This lowers your||
6268|049|U|chance of getting HIV complications (such as new infections,||
6268|050|U|cancer) and improves your quality of life. Nevirapine belongs to||
6268|051|U|a class of drugs known as non-nucleoside reverse transcriptase||
6268|052|U|inhibitors (NNRTIs).||
6268|053|U|   Nevirapine is not a cure for HIV infection. To decrease your||
6268|054|U|risk of spreading HIV disease to others, continue to take all HIV||
6268|055|U|medications exactly as prescribed by your doctor. Use an||
6268|056|U|effective barrier method (latex or polyurethane condoms/dental||
6268|057|U|dams) during sexual activity as directed by your doctor. Do not||
6268|058|U|share personal items (such as needles/syringes, toothbrushes, and||
6268|059|U|razors) that may have contacted blood or other body fluids.||
6268|060|U|Consult your doctor or pharmacist for more details.||
6268|061|U|   Nevirapine should not be used to prevent HIV infection after||
6268|062|U|accidental exposure (such as needle sticks, blood/bodily fluid||
6268|063|U|contact). Different HIV medications are used to prevent infection||
6268|064|U|after exposure.||
6268|065|B|||
6268|066|H|HOW TO USE:  Read the Medication Guide and, if available, the||
6268|067|H|Patient Information Leaflet provided by your pharmacist before||
6268|068|H|you start using nevirapine and each time you get a refill. If you||
6268|069|H|have any questions, ask your doctor or pharmacist.||
6268|070|H|   Take this medication by mouth with or without food as directed||
6268|071|H|by your doctor, usually once daily for the first 14 days when you||
6268|072|H|start treatment, and then twice daily.||
6268|073|H|   If liver problems or skin/allergic reactions occur while you||
6268|074|H|are taking this medication once daily, get medical help right||
6268|075|H|away and do not increase the dose to twice daily.||
6268|076|H|   If you are using the liquid suspension form of this||
6268|077|H|medication, shake the bottle gently before each dose. Carefully||
6268|078|H|measure the dose using a special measuring device/spoon. Do not||
6268|079|H|use a household spoon because you may not get the correct dose.||
6268|080|H|If you are using a dosing cup, rinse the cup with water after||
6268|081|H|taking the medication and drink all of the rinse water to make||
6268|082|H|sure you take the full dose.||
6268|083|H|   The dosage is based on your medical condition and response to||
6268|084|H|treatment. Children's dosage is also based on body size.||
6268|085|H|   Do not stay on the once-daily dosing schedule for more than 28||
6268|086|H|days. If you approach that period of time, your doctor should||
6268|087|H|consider switching you to another medication. Consult your doctor||
6268|088|H|for more details.||
6268|089|H|   If you stop taking this medication for more than 7 days for||
6268|090|H|reasons other than the serious reactions described in the Warning||
6268|091|H|section, ask your doctor for directions on how to restart||
6268|092|H|treatment. You may need to take this medication once daily again||
6268|093|H|for the first 14 days to decrease the risk of serious side||
6268|094|H|effects.||
6268|095|H|   It is very important to keep taking this medication (and other||
6268|096|H|HIV medications) exactly as prescribed by your doctor. Do not||
6268|097|H|skip any doses. Do not increase your dose, take this drug more||
6268|098|H|often than prescribed, or stop taking it (or other HIV medicines)||
6268|099|H|even for a short time unless directed to do so by your doctor.||
6268|100|H|Skipping or changing your dose without approval from your doctor||
6268|101|H|may cause the amount of virus to increase, make the infection||
6268|102|H|more difficult to treat (resistant), or worsen side effects.||
6268|103|H|   For the best effect, take this medication at evenly spaced||
6268|104|H|times. To help you remember, take this medication at the same||
6268|105|H|times every day.||
6268|106|B|||
6268|107|S|SIDE EFFECTS:  See also Warning section.||
6268|108|S|   Tiredness, nausea, vomiting, or diarrhea may occur. Drowsiness||
6268|109|S|may rarely occur. If any of these effects last or get worse, tell||
6268|110|S|your doctor or pharmacist promptly.||
6268|111|S|   Remember that this medication has been prescribed because your||
6268|112|S|doctor has judged that the benefit to you is greater than the||
6268|113|S|risk of side effects. Many people using this medication do not||
6268|114|S|have serious side effects.||
6268|115|S|   As your immune system gets stronger, it can begin to fight off||
6268|116|S|infections you already had, possibly causing disease symptoms to||
6268|117|S|come back. You could also have symptoms if your immune system||
6268|118|S|becomes overactive. This reaction may happen at any time (soon||
6268|119|S|after starting HIV treatment or many months later). Tell your||
6268|120|S|doctor right away if you have any serious symptoms, including:||
6268|121|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
6268|122|S|that doesn't go away, headaches that are severe or don't go away,||
6268|123|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
6268|124|S|changes, signs of infection (such as sore throat that doesn't go||
6268|125|S|away, fever, chills, non-healing skin sores), signs of an||
6268|126|S|overactive thyroid (such as irritability, nervousness, heat||
6268|127|S|intolerance, fast/pounding/irregular heartbeat).||
6268|128|S|   Nevirapine can commonly cause a rash that is usually not||
6268|129|S|serious. However, you may not be able to tell it apart from a||
6268|130|S|rare rash that could be a sign of a severe reaction. Get medical||
6268|131|S|help right away if you develop any rash.||
6268|132|S|   Changes in body fat may occur while you are taking this||
6268|133|S|medication (such as increased fat in the upper back and stomach||
6268|134|S|areas, decreased fat in the arms and legs). The cause and||
6268|135|S|long-term effects of these changes are unknown. Discuss the risks||
6268|136|S|and benefits of treatment with your doctor, as well as the||
6268|137|S|possible use of exercise to reduce this side effect.||
6268|138|S|   A very serious allergic reaction to this drug is rare, but get||
6268|139|S|medical help right away if it occurs. See the Warning section for||
6268|140|S|more details.||
6268|141|S|   This is not a complete list of possible side effects. If you||
6268|142|S|notice other effects not listed above, contact your doctor or||
6268|143|S|pharmacist.||
6268|144|S|   In the US -||
6268|145|S|   Call your doctor for medical advice about side effects. You||
6268|146|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6268|147|S|www.fda.gov/medwatch.||
6268|148|S|   In Canada - Call your doctor for medical advice about side||
6268|149|S|effects. You may report side effects to Health Canada at||
6268|150|S|1-866-234-2345.||
6268|151|B|||
6268|152|P|PRECAUTIONS:  Before taking nevirapine, tell your doctor or||
6268|153|P|pharmacist if you are allergic to it; or if you have any other||
6268|154|P|allergies. This product may contain inactive ingredients, which||
6268|155|P|can cause allergic reactions or other problems. Talk to your||
6268|156|P|pharmacist for more details.||
6268|157|P|   Before using this medication, tell your doctor or pharmacist||
6268|158|P|your medical history, especially of: liver problems (such as||
6268|159|P|hepatitis B or C, cirrhosis), kidney dialysis, lactose or||
6268|160|P|galactose intolerance.||
6268|161|P|   This drug may rarely make you drowsy. Alcohol or marijuana||
6268|162|P|(cannabis) can make you more drowsy. Do not drive, use machinery,||
6268|163|P|or do anything that needs alertness until you can do it safely.||
6268|164|P|Limit alcoholic beverages. Talk to your doctor if you are using||
6268|165|P|marijuana (cannabis).||
6268|166|P|   Before having surgery, tell your doctor or dentist about all||
6268|167|P|the products you use (including prescription drugs,||
6268|168|P|nonprescription drugs, and herbal products).||
6268|169|P|   During pregnancy, this medication should be used only when||
6268|170|P|clearly needed. Treatment can lower the risk of passing HIV||
6268|171|P|infection to your baby, and nevirapine may be part of that||
6268|172|P|treatment. Discuss the risks and benefits with your doctor.||
6268|173|P|   This medication passes into breast milk. Because breast milk||
6268|174|P|may transmit HIV, consult your doctor before breastfeeding.||
6268|175|B|||
6268|176|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6268|177|I|medications work or increase your risk for serious side effects.||
6268|178|I|This document does not contain all possible drug interactions.||
6268|179|I|Keep a list of all the products you use (including||
6268|180|I|prescription/nonprescription drugs and herbal products) and share||
6268|181|I|it with your doctor and pharmacist. Do not start, stop, or change||
6268|182|I|the dosage of any medicines without your doctor's approval.||
6268|183|I|   Some products that may interact with this drug include:||
6268|184|I|orlistat, rifabutin, warfarin.||
6268|185|I|   Other medications can affect the removal of nevirapine from||
6268|186|I|your body, which may affect how nevirapine works. Examples||
6268|187|I|include rifamycins (such as rifampin), St. John's wort, among||
6268|188|I|others.||
6268|189|I|   Nevirapine can speed up the removal of many other medications||
6268|190|I|from your body, which may affect how they work. Examples of||
6268|191|I|affected drugs include antiarrhythmics (such as amiodarone),||
6268|192|I|atazanavir, cobicistat, elvitegravir, some drugs used to treat||
6268|193|I|seizures (such as clonazepam), azole antifungals (such as||
6268|194|I|itraconazole, ketoconazole), macrolide antibiotics (such as||
6268|195|I|clarithromycin), methadone, among others.||
6268|196|I|   Do not use prednisone to prevent a rash because it can||
6268|197|I|actually increase the risk of a rash during the first 6 weeks of||
6268|198|I|nevirapine treatment. Ask your doctor for more details.||
6268|199|I|   This medication may decrease the effectiveness of hormonal||
6268|200|I|birth control such as pills, patch, or ring. This could cause||
6268|201|I|pregnancy. Discuss with your doctor or pharmacist if you should||
6268|202|I|use reliable backup birth control methods while using this||
6268|203|I|medication. Also tell your doctor if you have any new spotting or||
6268|204|I|breakthrough bleeding, because these may be signs that your birth||
6268|205|I|control is not working well.||
6268|206|B|||
6268|207|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6268|208|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6268|209|O|poison control center right away. US residents can call||
6268|210|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6268|211|B|||
6268|212|N|NOTES:  Do not share this medication with others.||
6268|213|N|   Lab and/or medical tests (such as liver function, viral load,||
6268|214|N|T-cell counts) should be done while you are taking this||
6268|215|N|medication. Keep all medical and lab appointments. Consult your||
6268|216|N|doctor for more details.||
6268|217|B|||
6268|218|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6268|219|D|remember. If it is near the time of the next dose, skip the||
6268|220|D|missed dose. Take your next dose at the regular time. Do not||
6268|221|D|double the dose to catch up.||
6268|222|B|||
6268|223|R|STORAGE:  Store at room temperature away from light and moisture.||
6268|224|R|Do not store in the bathroom. Keep all medications away from||
6268|225|R|children and pets.||
6268|226|R|   Do not flush medications down the toilet or pour them into a||
6268|227|R|drain unless instructed to do so. Properly discard this product||
6268|228|R|when it is expired or no longer needed. Consult your pharmacist||
6268|229|R|or local waste disposal company.||
6268|230|B|||
6268|231|A|Information last revised April 2025.||
6268|232|A|Copyright(c) 2025 First Databank, Inc.||
6268|233|B|||
6269|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6269|002|Z|does NOT have all possible information about this product. This||
6269|003|Z|information does not assure that this product is safe, effective,||
6269|004|Z|or appropriate for you. This information is not individual||
6269|005|Z|medical advice and does not substitute for the advice of your||
6269|006|Z|health care professional. Always ask your health care||
6269|007|Z|professional for complete information about this product and your||
6269|008|Z|specific health needs.||
6269|009|B|||
6269|010|T|CEFACLOR SUSTAINED-ACTION TABLET - ORAL||
6269|011|F|(SEF-a-klor)||
6269|012|B|||
6269|013|C|COMMON BRAND NAME(S): Ceclor CD||
6269|014|B|||
6269|015|U|USES:  This medication is a cephalosporin-type antibiotic used to||
6269|016|U|treat a wide variety of bacterial infections (such as skin and||
6269|017|U|respiratory tract infections). It works by stopping the growth of||
6269|018|U|bacteria.||
6269|019|U|   This antibiotic only treats bacterial infections. It will not||
6269|020|U|work for viral infections (such as common cold, flu). Unnecessary||
6269|021|U|use or overuse of any antibiotic can lead to its decreased||
6269|022|U|effectiveness.||
6269|023|B|||
6269|024|H|HOW TO USE:  Take this medication by mouth with a meal as||
6269|025|H|directed by your doctor, usually every 12 hours. Swallow this||
6269|026|H|medication and then drink a full glass of water (8 ounces or 240||
6269|027|H|milliliters). Swallow the tablets whole. Do not crush or chew the||
6269|028|H|tablets. Doing so can release all of the drug at once, increasing||
6269|029|H|the risk of side effects.||
6269|030|H|   For the best effect, take this antibiotic at evenly spaced||
6269|031|H|times. To help you remember, take this medication at the same||
6269|032|H|time(s) every day.||
6269|033|H|   Continue to take this medication until the full prescribed||
6269|034|H|amount is finished, even if symptoms disappear after a few days.||
6269|035|H|Stopping the medication too early may result in a return of the||
6269|036|H|infection.||
6269|037|H|   Antacids may decrease the absorption of this medication. If||
6269|038|H|you use antacids, take them at least 1 hour apart from this drug.||
6269|039|H|   Tell your doctor if your condition lasts or gets worse.||
6269|040|B|||
6269|041|S|SIDE EFFECTS:  Stomach upset, headache, nausea, vomiting, or||
6269|042|S|diarrhea may occur. If any of these effects last or get worse,||
6269|043|S|tell your doctor or pharmacist promptly.||
6269|044|S|   Remember that this medication has been prescribed because your||
6269|045|S|doctor has judged that the benefit to you is greater than the||
6269|046|S|risk of side effects. Many people using this medication do not||
6269|047|S|have serious side effects.||
6269|048|S|   Tell your doctor right away if you have any serious side||
6269|049|S|effects, including: signs of liver problems (such as||
6269|050|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
6269|051|S|yellowing eyes/skin, dark urine), unusual joint pain, new signs||
6269|052|S|of infection (such as sore throat that doesn't go away, fever,||
6269|053|S|chills), easy bruising/bleeding, signs of kidney problems (such||
6269|054|S|as change in the amount of urine), mental/mood changes (such as||
6269|055|S|confusion).||
6269|056|S|   This medication may rarely cause a severe intestinal condition||
6269|057|S|due to a bacteria called C. difficile. This condition may occur||
6269|058|S|during treatment or weeks to months after treatment has stopped.||
6269|059|S|Tell your doctor right away if you develop: diarrhea that doesn't||
6269|060|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
6269|061|S|stool.||
6269|062|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
6269|063|S|products because they may make symptoms worse.||
6269|064|S|   Use of this medication for prolonged or repeated periods may||
6269|065|S|result in oral thrush or a new vaginal yeast infection (oral or||
6269|066|S|vaginal fungal infection). Contact your doctor if you notice||
6269|067|S|white patches in your mouth, a change in vaginal discharge or||
6269|068|S|other new symptoms.||
6269|069|S|   A very serious allergic reaction to this drug is rare.||
6269|070|S|However, get medical help right away if you notice any symptoms||
6269|071|S|of a serious allergic reaction, including: rash, itching/swelling||
6269|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6269|073|S|breathing.||
6269|074|S|   This is not a complete list of possible side effects. If you||
6269|075|S|notice other effects not listed above, contact your doctor or||
6269|076|S|pharmacist.||
6269|077|S|   In the US -||
6269|078|S|   Call your doctor for medical advice about side effects. You||
6269|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6269|080|S|www.fda.gov/medwatch.||
6269|081|S|   In Canada - Call your doctor for medical advice about side||
6269|082|S|effects. You may report side effects to Health Canada at||
6269|083|S|1-866-234-2345.||
6269|084|B|||
6269|085|P|PRECAUTIONS:  Before taking cefaclor, tell your doctor or||
6269|086|P|pharmacist if you are allergic to it; or to penicillins or other||
6269|087|P|cephalosporins; or if you have any other allergies. This product||
6269|088|P|may contain inactive ingredients, which can cause allergic||
6269|089|P|reactions or other problems. Talk to your pharmacist for more||
6269|090|P|details.||
6269|091|P|   Before using this medication, tell your doctor or pharmacist||
6269|092|P|your medical history, especially of: kidney disease, intestinal||
6269|093|P|disease (colitis).||
6269|094|P|   Cefaclor may cause live bacterial vaccines (such as typhoid||
6269|095|P|vaccine) to not work well. Tell your health care professional||
6269|096|P|that you are using cefaclor before having any||
6269|097|P|immunizations/vaccinations.||
6269|098|P|   Before having surgery, tell your doctor or dentist about all||
6269|099|P|the products you use (including prescription drugs,||
6269|100|P|nonprescription drugs, and herbal products).||
6269|101|P|   During pregnancy, this medication should be used only when||
6269|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
6269|103|P|   This medication passes into breast milk. Consult your doctor||
6269|104|P|before breastfeeding.||
6269|105|B|||
6269|106|I|DRUG INTERACTIONS:  See also How to Use section.||
6269|107|I|   Drug interactions may change how your medications work or||
6269|108|I|increase your risk for serious side effects. This document does||
6269|109|I|not contain all possible drug interactions. Keep a list of all||
6269|110|I|the products you use (including prescription/nonprescription||
6269|111|I|drugs and herbal products) and share it with your doctor and||
6269|112|I|pharmacist. Do not start, stop, or change the dosage of any||
6269|113|I|medicines without your doctor's approval.||
6269|114|I|   This medication may interfere with certain lab tests (such as||
6269|115|I|certain diabetic urine tests), possibly causing false test||
6269|116|I|results. Make sure lab personnel and all your doctors know you||
6269|117|I|use this drug.||
6269|118|B|||
6269|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6269|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6269|121|O|poison control center right away. US residents can call||
6269|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6269|123|O|Symptoms of overdose may include severe vomiting, seizures.||
6269|124|B|||
6269|125|N|NOTES:  Do not share this medication with others.||
6269|126|N|   This medication has been prescribed for your current condition||
6269|127|N|only. Do not use it later for another infection unless your||
6269|128|N|doctor tells you to.||
6269|129|B|||
6269|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6269|131|D|If it is near the time of the next dose, skip the missed dose.||
6269|132|D|Use your next dose at the regular time. Do not double the dose to||
6269|133|D|catch up.||
6269|134|B|||
6269|135|R|STORAGE:  Store at room temperature away from light and moisture.||
6269|136|R|Do not store in the bathroom. Keep all medications away from||
6269|137|R|children and pets.||
6269|138|R|   Do not flush medications down the toilet or pour them into a||
6269|139|R|drain unless instructed to do so. Properly discard this product||
6269|140|R|when it is expired or no longer needed. Consult your pharmacist||
6269|141|R|or local waste disposal company.||
6269|142|B|||
6269|143|A|Information last revised May 2025.||
6269|144|A|Copyright(c) 2025 First Databank, Inc.||
6269|145|B|||
6272|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6272|002|Z|does NOT have all possible information about this product. This||
6272|003|Z|information does not assure that this product is safe, effective,||
6272|004|Z|or appropriate for you. This information is not individual||
6272|005|Z|medical advice and does not substitute for the advice of your||
6272|006|Z|health care professional. Always ask your health care||
6272|007|Z|professional for complete information about this product and your||
6272|008|Z|specific health needs.||
6272|009|B|||
6272|010|T|PENTOSTATIN - INJECTION||
6272|011|F|(PEN-toe-STAT-in)||
6272|012|B|||
6272|013|C|COMMON BRAND NAME(S): Nipent||
6272|014|B|||
6272|015|U|USES:  Pentostatin is used to treat a certain type of cancer||
6272|016|U|(hairy cell leukemia). It works by slowing or stopping the growth||
6272|017|U|of cancer cells.||
6272|018|B|||
6272|019|V|OTHER USES:  This section contains uses of this drug that are not||
6272|020|V|listed in the approved professional labeling for the drug but||
6272|021|V|that may be prescribed by your health care professional. Use this||
6272|022|V|drug for a condition that is listed in this section only if it||
6272|023|V|has been so prescribed by your health care professional.||
6272|024|V|   This drug may also be used for other types of cancer (such as||
6272|025|V|chronic lymphocytic leukemia).||
6272|026|B|||
6272|027|H|HOW TO USE:  This medication is given by injection into a vein by||
6272|028|H|a health care professional as directed by your doctor, usually||
6272|029|H|every other week. The dosage is based on your medical condition,||
6272|030|H|body size, and response to treatment.||
6272|031|H|   To help reduce side effects to the kidneys, your doctor may||
6272|032|H|prescribe IV fluids before and after you receive pentostatin.||
6272|033|B|||
6272|034|S|SIDE EFFECTS:  Mild rash/itching may occur. Tell your doctor or||
6272|035|S|pharmacist promptly if any of these effects occur. Nausea,||
6272|036|S|vomiting, diarrhea, loss of appetite, increased sweating, or||
6272|037|S|mouth sores may also occur. If any of these effects last or get||
6272|038|S|worse, tell your doctor or pharmacist promptly.||
6272|039|S|   People using this medication may have serious side effects.||
6272|040|S|However, you have been prescribed this drug because your doctor||
6272|041|S|has judged that the benefit to you is greater than the risk of||
6272|042|S|side effects. Careful monitoring by your doctor may decrease your||
6272|043|S|risk.||
6272|044|S|   Tell your doctor right away if you have any serious side||
6272|045|S|effects, including: signs of kidney problems (such as change in||
6272|046|S|the amount of urine), dark urine, yellowing eyes/skin, severe||
6272|047|S|stomach/abdominal pain, dizziness, drowsiness, headache, trouble||
6272|048|S|sleeping, shortness of breath, cough, unusual weakness/tiredness,||
6272|049|S|swelling ankles/feet, muscle/joint pain, muscle spasm,||
6272|050|S|mental/mood changes (such as depression, anxiety),||
6272|051|S|numbness/tingling of the skin, decreased sexual ability/interest,||
6272|052|S|fainting, fast/slow/irregular heartbeat, vision/hearing changes,||
6272|053|S|pain/redness/swelling of arms or legs.||
6272|054|S|   Get medical help right away if you have any very serious side||
6272|055|S|effects, including: seizures, chest pain.||
6272|056|S|   This medication may cause very serious blood disorders||
6272|057|S|(decreased bone marrow function leading to low number of blood||
6272|058|S|cells such as red cells, white cells, and platelets). This effect||
6272|059|S|can cause anemia, decrease your body's ability to fight an||
6272|060|S|infection, or cause your body to bruise or bleed more easily.||
6272|061|S|Tell your doctor right away if you develop any of the following||
6272|062|S|symptoms: signs of infection (such as sore throat that doesn't go||
6272|063|S|away, fever, chills), easy bruising/bleeding, unusual tiredness,||
6272|064|S|fast/pounding heartbeat.||
6272|065|S|   A very serious allergic reaction to this drug is rare.||
6272|066|S|However, get medical help right away if you notice any symptoms||
6272|067|S|of a serious allergic reaction, including: rash, itching/swelling||
6272|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6272|069|S|breathing.||
6272|070|S|   This is not a complete list of possible side effects. If you||
6272|071|S|notice other effects not listed above, contact your doctor or||
6272|072|S|pharmacist.||
6272|073|S|   In the US -||
6272|074|S|   Call your doctor for medical advice about side effects. You||
6272|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6272|076|S|www.fda.gov/medwatch.||
6272|077|S|   In Canada - Call your doctor for medical advice about side||
6272|078|S|effects. You may report side effects to Health Canada at||
6272|079|S|1-866-234-2345.||
6272|080|B|||
6272|081|P|PRECAUTIONS:  Before using pentostatin, tell your doctor or||
6272|082|P|pharmacist if you are allergic to it; or if you have any other||
6272|083|P|allergies. This product may contain inactive ingredients, which||
6272|084|P|can cause allergic reactions or other problems. Talk to your||
6272|085|P|pharmacist for more details.||
6272|086|P|   Before using this medication, tell your doctor or pharmacist||
6272|087|P|your medical history, especially of: kidney disease, liver||
6272|088|P|disease, recent/current infections, blood/bone marrow disorder.||
6272|089|P|   Before having surgery, tell your doctor or dentist about all||
6272|090|P|the products you use (including prescription drugs,||
6272|091|P|nonprescription drugs, and herbal products).||
6272|092|P|   Tell your health care professional that you are using||
6272|093|P|pentostatin before having any immunizations/vaccinations. Avoid||
6272|094|P|contact with people who have recently received live vaccines||
6272|095|P|(such as flu vaccine inhaled through the nose).||
6272|096|P|   Pentostatin can make you more likely to get infections or may||
6272|097|P|make current infections worse. Stay away from anyone who has an||
6272|098|P|infection that may easily spread (such as chickenpox, COVID-19,||
6272|099|P|measles, flu). Talk to your doctor if you have been exposed to an||
6272|100|P|infection or for more details.||
6272|101|P|   To lower your risk of getting cut, bruised, or injured, use||
6272|102|P|caution with sharp objects like razors and nail cutters, and||
6272|103|P|avoid activities such as contact sports.||
6272|104|P|   Tell your doctor if you are pregnant or plan to become||
6272|105|P|pregnant. You should not become pregnant while using pentostatin.||
6272|106|P|Pentostatin may harm an unborn baby. Women using this medication||
6272|107|P|should ask about reliable forms of birth control during treatment||
6272|108|P|and for 6 months after the last dose. Men using this medication||
6272|109|P|should ask about reliable forms of birth control during treatment||
6272|110|P|and for 3 months after the last dose. If you or your partner||
6272|111|P|becomes pregnant, talk to your doctor right away about the risks||
6272|112|P|and benefits of this medication.||
6272|113|P|   It is unknown if this medication passes into breast milk.||
6272|114|P|Because of the possible risk to the infant, breastfeeding is not||
6272|115|P|recommended while using this medication and for 1 week after the||
6272|116|P|last dose. Consult your doctor before breastfeeding.||
6272|117|B|||
6272|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6272|119|I|medications work or increase your risk for serious side effects.||
6272|120|I|This document does not contain all possible drug interactions.||
6272|121|I|Keep a list of all the products you use (including||
6272|122|I|prescription/nonprescription drugs and herbal products) and share||
6272|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
6272|124|I|the dosage of any medicines without your doctor's approval.||
6272|125|I|   Some products that may interact with this drug include:||
6272|126|I|fludarabine, vidarabine.||
6272|127|B|||
6272|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6272|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6272|130|O|poison control center right away. US residents can call||
6272|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6272|132|O|Symptoms of overdose may include: trouble breathing, seizures,||
6272|133|O|fainting, change in the amount of urine, severe stomach/abdominal||
6272|134|O|pain.||
6272|135|B|||
6272|136|N|NOTES:  Lab and/or medical tests (such as blood count,||
6272|137|N|kidney/liver function) should be done while you are using this||
6272|138|N|medication. Keep all medical and lab appointments. Consult your||
6272|139|N|doctor for more details.||
6272|140|B|||
6272|141|D|MISSED DOSE:  It is important to get each dose of this medication||
6272|142|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6272|143|D|right away for a new dosing schedule.||
6272|144|B|||
6272|145|R|STORAGE:  Not applicable. This medication is given in a clinic||
6272|146|R|and will not be stored at home.||
6272|147|B|||
6272|148|M|MEDICAL ALERT:  Your condition can cause complications in a||
6272|149|M|medical emergency. For information about enrolling in MedicAlert,||
6272|150|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6272|151|B|||
6272|152|A|Information last revised November 2025.||
6272|153|A|Copyright(c) 2025 First Databank, Inc.||
6272|154|B|||
6273|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6273|002|Z|does NOT have all possible information about this product. This||
6273|003|Z|information does not assure that this product is safe, effective,||
6273|004|Z|or appropriate for you. This information is not individual||
6273|005|Z|medical advice and does not substitute for the advice of your||
6273|006|Z|health care professional. Always ask your health care||
6273|007|Z|professional for complete information about this product and your||
6273|008|Z|specific health needs.||
6273|009|B|||
6273|010|T|MITOTANE - ORAL||
6273|011|F|(MYE-toe-tane)||
6273|012|B|||
6273|013|C|COMMON BRAND NAME(S): Lysodren||
6273|014|B|||
6273|015|W|WARNING:  Mitotane can make it more difficult for your body to||
6273|016|W|respond to physical stress. Before having surgery or emergency||
6273|017|W|treatment, or if you get a serious illness/injury, tell your||
6273|018|W|doctor or dentist that you are using this medication. Your doctor||
6273|019|W|may need to stop this medication and prescribe another medication||
6273|020|W|(corticosteroid) during this time.||
6273|021|B|||
6273|022|U|USES:  Mitotane is used to treat cancer of the adrenal glands. It||
6273|023|U|works by slowing the growth of or killing adrenal gland cells and||
6273|024|U|also decreases the amount of hormones made by the adrenal gland.||
6273|025|B|||
6273|026|V|OTHER USES:  This section contains uses of this drug that are not||
6273|027|V|listed in the approved professional labeling for the drug but||
6273|028|V|that may be prescribed by your health care professional. Use this||
6273|029|V|drug for a condition that is listed in this section only if it||
6273|030|V|has been so prescribed by your health care professional.||
6273|031|V|   This drug may also be used for a disorder which causes too||
6273|032|V|much hormone (cortisol) to be made by the adrenal glands||
6273|033|V|(Cushing's syndrome).||
6273|034|B|||
6273|035|H|HOW TO USE:  Read the Medication Guide and, if available, the||
6273|036|H|Patient Information Leaflet provided by your pharmacist before||
6273|037|H|you start taking mitotane and each time you get a refill. If you||
6273|038|H|have any questions, ask your doctor or pharmacist.||
6273|039|H|   Take this medication by mouth with fat-containing food as||
6273|040|H|directed by your doctor, usually 3 or 4 times daily. The dosage||
6273|041|H|is based on your medical condition and response to treatment.||
6273|042|H|   Swallow the tablets whole. Do not crush, chew or break the||
6273|043|H|tablets. Do not take tablets that are broken or crushed.||
6273|044|H|   You and/or your caregiver should wear disposable gloves while||
6273|045|H|handling this medication. If powder from a crushed or broken||
6273|046|H|tablet touches the skin, wash the skin area thoroughly with soap||
6273|047|H|and water. Learn how to safely handle and dispose of this||
6273|048|H|medication and its container.||
6273|049|H|   If you vomit after taking a dose, do not take another dose at||
6273|050|H|that time. Take your next dose at the regular time.||
6273|051|H|   Use this medication regularly to get the most benefit from it.||
6273|052|H|To help you remember, take it at the same times each day. Do not||
6273|053|H|increase your dose or use this drug more often or for longer than||
6273|054|H|prescribed. Your condition will not improve any faster, and your||
6273|055|H|risk of serious side effects will increase.||
6273|056|H|   Since this drug can be absorbed through the skin and lungs and||
6273|057|H|may harm an unborn baby, women who are pregnant or who may become||
6273|058|H|pregnant should not handle this medication or breathe the dust||
6273|059|H|from the tablets.||
6273|060|B|||
6273|061|S|SIDE EFFECTS:  Dizziness, drowsiness, nausea/vomiting, diarrhea,||
6273|062|S|loss of appetite, or weakness may occur. If any of these effects||
6273|063|S|last or get worse, tell your doctor or pharmacist promptly.||
6273|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
6273|065|S|slowly when rising from a sitting or lying position.||
6273|066|S|   Remember that this medication has been prescribed because your||
6273|067|S|doctor has judged that the benefit to you is greater than the||
6273|068|S|risk of side effects. Many people using this medication do not||
6273|069|S|have serious side effects.||
6273|070|S|   Tell your doctor right away if you have any serious side||
6273|071|S|effects, including: unusual/rapid weight loss, mental/mood||
6273|072|S|changes (such as depression, confusion), vision changes (such as||
6273|073|S|blurred vision, double vision), fainting, vomit that looks like||
6273|074|S|coffee grounds, breast enlargement (gynecomastia) in men, signs||
6273|075|S|of an ovarian cyst (such as unusual vaginal bleeding, pelvic||
6273|076|S|pain), signs of liver problems (such as nausea/vomiting that||
6273|077|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
6273|078|S|eyes/skin, dark urine).||
6273|079|S|   This medication may lead to a low number of blood cells such||
6273|080|S|as red cells, white cells, and platelets. This effect can cause||
6273|081|S|anemia, decrease your body's ability to fight an infection, or||
6273|082|S|cause easy bruising/bleeding. Tell your doctor right away if you||
6273|083|S|develop any of the following symptoms: unusual tiredness, pale||
6273|084|S|skin, signs of infection (such as sore throat that doesn't go||
6273|085|S|away, fever, chills), easy bruising/bleeding.||
6273|086|S|   Mitotane can commonly cause a rash that is usually not||
6273|087|S|serious. However, you may not be able to tell it apart from a||
6273|088|S|rash that could be a sign of a severe reaction. Get medical help||
6273|089|S|right away if you develop any rash.||
6273|090|S|   A very serious allergic reaction to this drug is rare.||
6273|091|S|However, get medical help right away if you notice any symptoms||
6273|092|S|of a serious allergic reaction, including: rash, itching/swelling||
6273|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6273|094|S|breathing.||
6273|095|S|   This is not a complete list of possible side effects. If you||
6273|096|S|notice other effects not listed above, contact your doctor or||
6273|097|S|pharmacist.||
6273|098|S|   In the US -||
6273|099|S|   Call your doctor for medical advice about side effects. You||
6273|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6273|101|S|www.fda.gov/medwatch.||
6273|102|S|   In Canada - Call your doctor for medical advice about side||
6273|103|S|effects. You may report side effects to Health Canada at||
6273|104|S|1-866-234-2345.||
6273|105|B|||
6273|106|P|PRECAUTIONS:  See also Warning section.||
6273|107|P|   Before taking mitotane, tell your doctor or pharmacist if you||
6273|108|P|are allergic to it; or if you have any other allergies. This||
6273|109|P|product may contain inactive ingredients, which can cause||
6273|110|P|allergic reactions or other problems. Talk to your pharmacist for||
6273|111|P|more details.||
6273|112|P|   Before using this medication, tell your doctor or pharmacist||
6273|113|P|your medical history, especially of: liver disease, kidney||
6273|114|P|disease, bleeding problems.||
6273|115|P|   Mitotane can make you more likely to get infections or may||
6273|116|P|make current infections worse. Stay away from anyone who has an||
6273|117|P|infection that may easily spread (such as chickenpox, COVID-19,||
6273|118|P|measles, flu). Talk to your doctor if you have been exposed to an||
6273|119|P|infection or for more details.||
6273|120|P|   Do not have immunizations/vaccinations without the consent of||
6273|121|P|your doctor. Avoid contact with people who have recently received||
6273|122|P|live vaccines (such as flu vaccine inhaled through the nose).||
6273|123|P|   To lower the chance of getting cut, bruised, or injured, use||
6273|124|P|caution with sharp objects like razors and nail cutters, and||
6273|125|P|avoid activities such as contact sports.||
6273|126|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6273|127|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6273|128|P|machinery, or do anything that needs alertness until you can do||
6273|129|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
6273|130|P|are using marijuana (cannabis).||
6273|131|P|   Before having surgery, tell your doctor or dentist about all||
6273|132|P|the products you use (including prescription drugs,||
6273|133|P|nonprescription drugs, and herbal products).||
6273|134|P|   Since this drug can be absorbed through the skin and lungs and||
6273|135|P|may harm an unborn baby, women who are pregnant or who may become||
6273|136|P|pregnant should not handle this medication or breathe the dust||
6273|137|P|from the tablets.||
6273|138|P|   Tell your doctor if you are pregnant or plan to become||
6273|139|P|pregnant. You should not become pregnant while using mitotane.||
6273|140|P|Mitotane may harm an unborn baby. Your doctor should order a||
6273|141|P|pregnancy test before you start this medication. Ask about||
6273|142|P|reliable forms of non-hormonal birth control (such as condoms,||
6273|143|P|diaphragm with spermicide) while using this medication and for||
6273|144|P|some time after the last dose. Your doctor will do blood tests to||
6273|145|P|decide when you can stop using birth control. If you become||
6273|146|P|pregnant, talk to your doctor right away about the risks and||
6273|147|P|benefits of this medication.||
6273|148|P|   This medication passes into breast milk and may harm a nursing||
6273|149|P|infant. Breastfeeding is not recommended while using this||
6273|150|P|medication and for some time after the last dose. Your doctor||
6273|151|P|will do blood tests to see when you can start breastfeeding.||
6273|152|P|Consult your doctor before breastfeeding.||
6273|153|B|||
6273|154|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6273|155|I|medications work or increase your risk for serious side effects.||
6273|156|I|This document does not contain all possible drug interactions.||
6273|157|I|Keep a list of all the products you use (including||
6273|158|I|prescription/nonprescription drugs and herbal products) and share||
6273|159|I|it with your doctor and pharmacist. Do not start, stop, or change||
6273|160|I|the dosage of any medicines without your doctor's approval.||
6273|161|I|   This medication can speed up the removal of other medications||
6273|162|I|from your body, which may affect how they work. Examples of||
6273|163|I|affected drugs include cobicistat, doravirine, isavuconazonium,||
6273|164|I|lurasidone, naldemedine, nifedipine, ranolazine, tamoxifen,||
6273|165|I|voriconazole, among others.||
6273|166|I|   This medication may decrease the effectiveness of hormonal||
6273|167|I|birth control such as pills, patch, or ring. This could cause||
6273|168|I|pregnancy. Discuss with your doctor or pharmacist if you should||
6273|169|I|use reliable backup birth control methods while using this||
6273|170|I|medication. Also tell your doctor if you have any new spotting or||
6273|171|I|breakthrough bleeding, because these may be signs that your birth||
6273|172|I|control is not working well.||
6273|173|I|   Tell your doctor or pharmacist if you are taking other||
6273|174|I|products that cause drowsiness including alcohol, marijuana||
6273|175|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
6273|176|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
6273|177|I|zolpidem), muscle relaxants (such as carisoprodol,||
6273|178|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
6273|179|I|hydrocodone).||
6273|180|I|   Check the labels on all your medicines (such as allergy or||
6273|181|I|cough-and-cold products) because they may contain ingredients||
6273|182|I|that cause drowsiness. Ask your pharmacist about using those||
6273|183|I|products safely.||
6273|184|B|||
6273|185|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6273|186|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6273|187|O|poison control center right away. US residents can call||
6273|188|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6273|189|B|||
6273|190|N|NOTES:  Do not share this medication with others.||
6273|191|N|   Lab and/or medical tests (such as complete blood counts,||
6273|192|N|cortisol levels, kidney/liver function, mitotane blood levels,||
6273|193|N|thyroid function, pelvic ultrasound) should be done before you||
6273|194|N|start taking this medication and while you are taking it. Keep||
6273|195|N|all medical and lab appointments. Consult your doctor for more||
6273|196|N|details.||
6273|197|B|||
6273|198|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
6273|199|D|next dose at the regular time. Do not double the dose to catch||
6273|200|D|up.||
6273|201|B|||
6273|202|R|STORAGE:  Store at room temperature away from light and moisture.||
6273|203|R|Keep all medications away from children and pets.||
6273|204|R|   Do not flush medications down the toilet or pour them into a||
6273|205|R|drain unless instructed to do so. Properly discard this product||
6273|206|R|when it is expired or no longer needed. Consult your pharmacist||
6273|207|R|or local waste disposal company.||
6273|208|B|||
6273|209|M|MEDICAL ALERT:  Your condition can cause complications in a||
6273|210|M|medical emergency. For information about enrolling in MedicAlert,||
6273|211|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6273|212|B|||
6273|213|A|Information last revised March 2025.||
6273|214|A|Copyright(c) 2025 First Databank, Inc.||
6273|215|B|||
6274|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6274|002|Z|does NOT have all possible information about this product. This||
6274|003|Z|information does not assure that this product is safe, effective,||
6274|004|Z|or appropriate for you. This information is not individual||
6274|005|Z|medical advice and does not substitute for the advice of your||
6274|006|Z|health care professional. Always ask your health care||
6274|007|Z|professional for complete information about this product and your||
6274|008|Z|specific health needs.||
6274|009|B|||
6274|010|T|ZIPRASIDONE - ORAL||
6274|011|F|(zi-PRAS-i-done)||
6274|012|B|||
6274|013|C|COMMON BRAND NAME(S): Geodon||
6274|014|B|||
6274|015|W|WARNING:  There may be a slightly increased risk of serious,||
6274|016|W|possibly fatal side effects (such as stroke, heart failure,||
6274|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
6274|018|W|by older adults with dementia. This medication is not approved||
6274|019|W|for the treatment of dementia-related behavior problems. Discuss||
6274|020|W|the risks and benefits of this medication, as well as other||
6274|021|W|effective and possibly safer treatments for dementia-related||
6274|022|W|behavior problems, with the doctor.||
6274|023|W|   If you are using ziprasidone in combination with other||
6274|024|W|medication to treat depression, also carefully read the drug||
6274|025|W|information for the other medication.||
6274|026|B|||
6274|027|U|USES:  This medication is used to treat certain mental/mood||
6274|028|U|disorders (such as schizophrenia, bipolar disorder). Ziprasidone||
6274|029|U|belongs to a class of drugs known as atypical antipsychotics. It||
6274|030|U|works by helping to restore the balance of certain natural||
6274|031|U|substances in the brain.||
6274|032|B|||
6274|033|V|OTHER USES:  This section contains uses of this drug that are not||
6274|034|V|listed in the approved professional labeling for the drug but||
6274|035|V|that may be prescribed by your health care professional. Use this||
6274|036|V|drug for a condition that is listed in this section only if it||
6274|037|V|has been so prescribed by your health care professional.||
6274|038|V|   This drug may also be used in combination with other||
6274|039|V|medication for depression.||
6274|040|B|||
6274|041|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6274|042|H|from your pharmacist before you start taking ziprasidone and each||
6274|043|H|time you get a refill. If you have any questions, ask your doctor||
6274|044|H|or pharmacist.||
6274|045|H|   Take this medication by mouth with food as directed by your||
6274|046|H|doctor, usually twice daily. Swallow the capsules whole. Do not||
6274|047|H|open, crush, or chew the capsules.||
6274|048|H|   The dosage is based on your medical condition and response to||
6274|049|H|treatment. To reduce your risk of side effects, your doctor may||
6274|050|H|direct you to start this medication at a low dose and gradually||
6274|051|H|increase your dose. Follow your doctor's instructions carefully.||
6274|052|H|   Take this medication regularly to get the most benefit from||
6274|053|H|it. To help you remember, take it at the same time each day. Keep||
6274|054|H|taking this medication even if you feel well. Do not stop taking||
6274|055|H|this medication without consulting your doctor.||
6274|056|H|   Tell your doctor if your condition lasts or gets worse.||
6274|057|B|||
6274|058|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, weakness,||
6274|059|S|nausea, vomiting, runny nose, and cough may occur. If any of||
6274|060|S|these effects last or get worse, tell your doctor promptly.||
6274|061|S|   Dizziness and lightheadedness can increase the risk of||
6274|062|S|falling. Get up slowly when rising from a sitting or lying||
6274|063|S|position.||
6274|064|S|   Remember that this medication has been prescribed because your||
6274|065|S|doctor has judged that the benefit to you is greater than the||
6274|066|S|risk of side effects. Many people using this medication do not||
6274|067|S|have serious side effects.||
6274|068|S|   Tell your doctor right away if you have any serious side||
6274|069|S|effects, including: difficulty swallowing, muscle spasms, shaking||
6274|070|S|(tremor), mental/mood changes (such as restlessness), vision||
6274|071|S|changes, interrupted breathing during sleep.||
6274|072|S|   This drug may rarely make your blood sugar rise, which can||
6274|073|S|cause or worsen diabetes. Tell your doctor right away if you have||
6274|074|S|symptoms of high blood sugar such as increased thirst/urination.||
6274|075|S|If you already have diabetes, check your blood sugar regularly as||
6274|076|S|directed and share the results with your doctor. Your doctor may||
6274|077|S|need to adjust your diabetes medication, exercise program, or||
6274|078|S|diet.||
6274|079|S|   This drug may also rarely cause significant weight gain and a||
6274|080|S|rise in your blood cholesterol (or triglyceride) levels. These||
6274|081|S|effects, along with diabetes, may increase your risk for||
6274|082|S|developing heart disease. Discuss the risks and benefits of||
6274|083|S|treatment with your doctor.||
6274|084|S|   This drug may rarely cause a condition known as tardive||
6274|085|S|dyskinesia. In some cases, this condition may be permanent. Tell||
6274|086|S|your doctor right away if you develop any unusual/uncontrolled||
6274|087|S|movements (especially of the face, mouth, tongue, arms, or legs).||
6274|088|S|   This medication may increase a certain natural substance||
6274|089|S|(prolactin) made by your body. For females, this increase in||
6274|090|S|prolactin may result in unwanted breast milk, missed/stopped||
6274|091|S|periods, or difficulty becoming pregnant. For males, it may||
6274|092|S|result in decreased sexual ability, inability to produce sperm,||
6274|093|S|or enlarged breasts. If you develop any of these symptoms, tell||
6274|094|S|your doctor right away.||
6274|095|S|   Get medical help right away if you have any very serious side||
6274|096|S|effects, including: severe dizziness, fainting, seizures, signs||
6274|097|S|of liver damage (such as nausea/vomiting that doesn't stop, loss||
6274|098|S|of appetite, stomach/abdominal pain, yellowing eyes/skin).||
6274|099|S|   This medication may increase serotonin and rarely cause a very||
6274|100|S|serious condition called serotonin syndrome/toxicity. The risk||
6274|101|S|increases if you are also taking other drugs that increase||
6274|102|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
6274|103|S|take (see Drug Interactions section). Get medical help right away||
6274|104|S|if you develop some of the following symptoms: fast heartbeat,||
6274|105|S|hallucinations, loss of coordination, severe dizziness, severe||
6274|106|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
6274|107|S|unusual agitation/restlessness.||
6274|108|S|   This medication may rarely cause a very serious condition||
6274|109|S|called neuroleptic malignant syndrome (NMS). Get medical help||
6274|110|S|right away if you have any of the following symptoms: fever,||
6274|111|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
6274|112|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
6274|113|S|signs of kidney problems (such as change in the amount of urine).||
6274|114|S|   Rarely, males may have a painful or prolonged erection lasting||
6274|115|S|4 or more hours. If this occurs, stop using this drug and get||
6274|116|S|medical help right away, or permanent problems could occur.||
6274|117|S|   A very serious allergic reaction to this drug is rare.||
6274|118|S|However, get medical help right away if you notice any symptoms||
6274|119|S|of a serious allergic reaction, including: fever, swollen lymph||
6274|120|S|nodes, rash, itching/swelling (especially of the||
6274|121|S|face/tongue/throat), severe dizziness, trouble breathing.||
6274|122|S|   This is not a complete list of possible side effects. If you||
6274|123|S|notice other effects not listed above, contact your doctor or||
6274|124|S|pharmacist.||
6274|125|S|   In the US -||
6274|126|S|   Call your doctor for medical advice about side effects. You||
6274|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6274|128|S|www.fda.gov/medwatch.||
6274|129|S|   In Canada - Call your doctor for medical advice about side||
6274|130|S|effects. You may report side effects to Health Canada at||
6274|131|S|1-866-234-2345.||
6274|132|B|||
6274|133|P|PRECAUTIONS:  Before taking ziprasidone, tell your doctor or||
6274|134|P|pharmacist if you are allergic to it; or if you have any other||
6274|135|P|allergies. This product may contain inactive ingredients, which||
6274|136|P|can cause allergic reactions or other problems. Talk to your||
6274|137|P|pharmacist for more details.||
6274|138|P|   Before using this medication, tell your doctor or pharmacist||
6274|139|P|your medical history, especially of: dementia, seizures, low||
6274|140|P|white blood cell count, difficulty swallowing, heart disease||
6274|141|P|(such as coronary artery disease, irregular heartbeat), diabetes||
6274|142|P|(including family history), obesity, breathing trouble during||
6274|143|P|sleep (sleep apnea).||
6274|144|P|   Ziprasidone may cause a condition that affects the heart||
6274|145|P|rhythm (QT prolongation). QT prolongation can rarely cause||
6274|146|P|serious (rarely fatal) fast/irregular heartbeat and other||
6274|147|P|symptoms (such as severe dizziness, fainting) that need medical||
6274|148|P|attention right away.||
6274|149|P|   The risk of QT prolongation may be increased if you have||
6274|150|P|certain medical conditions or are taking other drugs that may||
6274|151|P|cause QT prolongation. Before using ziprasidone, tell your doctor||
6274|152|P|or pharmacist of all the drugs you take and if you have any of||
6274|153|P|the following conditions: certain heart problems (heart failure,||
6274|154|P|recent heart attack, slow heartbeat, QT prolongation in the EKG),||
6274|155|P|family history of certain heart problems (QT prolongation in the||
6274|156|P|EKG, sudden cardiac death).||
6274|157|P|   Low levels of potassium or magnesium in the blood may also||
6274|158|P|increase your risk of QT prolongation. This risk may increase if||
6274|159|P|you use certain drugs (such as diuretics/"water pills") or if you||
6274|160|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6274|161|P|Talk to your doctor about using ziprasidone safely.||
6274|162|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6274|163|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6274|164|P|machinery, or do anything that needs alertness until you can do||
6274|165|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6274|166|P|are using marijuana (cannabis).||
6274|167|P|   Before having surgery, tell your doctor or dentist about all||
6274|168|P|the products you use (including prescription drugs,||
6274|169|P|nonprescription drugs, and herbal products).||
6274|170|P|   This medication may make you sweat less, making you more||
6274|171|P|likely to get heat stroke. Avoid doing things that may cause you||
6274|172|P|to overheat, such as hard work or exercise in hot weather, or||
6274|173|P|using hot tubs. When the weather is hot, drink a lot of fluids||
6274|174|P|and dress lightly. If you overheat, quickly look for a place to||
6274|175|P|cool down and rest. Get medical help right away if you have a||
6274|176|P|fever that does not go away, mental/mood changes, headache, or||
6274|177|P|dizziness.||
6274|178|P|   Older adults may be more sensitive to the side effects of this||
6274|179|P|drug, especially drowsiness, dizziness, lightheadedness,||
6274|180|P|uncontrolled movements, and QT prolongation (see above).||
6274|181|P|Drowsiness, dizziness, and lightheadedness can increase the risk||
6274|182|P|of falling.||
6274|183|P|   During pregnancy, this medication should be used only when||
6274|184|P|clearly needed. Babies born to mothers who have used this drug||
6274|185|P|during the last 3 months of pregnancy may rarely develop symptoms||
6274|186|P|including muscle stiffness or shakiness, drowsiness,||
6274|187|P|feeding/breathing difficulties, or constant crying. If you notice||
6274|188|P|any of these symptoms in your newborn especially during their||
6274|189|P|first month, tell the doctor right away.||
6274|190|P|   Since untreated mental/mood problems (such as schizophrenia,||
6274|191|P|bipolar disorder, depression) can be a serious condition, do not||
6274|192|P|stop taking this medication unless directed by your doctor. If||
6274|193|P|you are planning pregnancy, become pregnant, or think you may be||
6274|194|P|pregnant, immediately discuss with your doctor the benefits and||
6274|195|P|risks of using this medication during pregnancy.||
6274|196|P|   It is unknown if this drug passes into breast milk. Because of||
6274|197|P|the possible risk to the infant, breastfeeding is not recommended||
6274|198|P|while using this drug. Consult your doctor before breastfeeding.||
6274|199|B|||
6274|200|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6274|201|I|medications work or increase your risk for serious side effects.||
6274|202|I|This document does not contain all possible drug interactions.||
6274|203|I|Keep a list of all the products you use (including||
6274|204|I|prescription/nonprescription drugs and herbal products) and share||
6274|205|I|it with your doctor and pharmacist. Do not start, stop, or change||
6274|206|I|the dosage of any medicines without your doctor's approval.||
6274|207|I|   Some products that may interact with this drug are:||
6274|208|I|dolasetron, metoclopramide.||
6274|209|I|   The risk of serotonin syndrome/toxicity increases if you are||
6274|210|I|also taking other drugs that increase serotonin. Examples include||
6274|211|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
6274|212|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
6274|213|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
6274|214|I|serotonin syndrome/toxicity may be more likely when you start or||
6274|215|I|increase the dose of these drugs.||
6274|216|I|   Taking MAO inhibitors with this medication may cause a serious||
6274|217|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
6274|218|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
6274|219|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
6274|220|I|selegiline, tranylcypromine) during treatment with this||
6274|221|I|medication. Most MAO inhibitors should also not be taken for two||
6274|222|I|weeks before and aftertreatment with this medication. Ask your||
6274|223|I|doctor when to start or stop taking this medication.||
6274|224|I|   Many drugs besides ziprasidone may affect the heart rhythm (QT||
6274|225|I|prolongation), including amiodarone, dofetilide, moxifloxacin,||
6274|226|I|pimozide, procainamide, quinidine, sotalol, tacrolimus,||
6274|227|I|thioridazine, among others.||
6274|228|I|   Tell your doctor or pharmacist if you are taking other||
6274|229|I|products that cause drowsiness such as opioid pain or cough||
6274|230|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6274|231|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
6274|232|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6274|233|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6274|234|I|diphenhydramine).||
6274|235|I|   Check the labels on all your medicines (such as allergy or||
6274|236|I|cough-and-cold products) because they may contain ingredients||
6274|237|I|that cause drowsiness. Ask your pharmacist about using those||
6274|238|I|products safely.||
6274|239|B|||
6274|240|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6274|241|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6274|242|O|poison control center right away. US residents can call||
6274|243|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6274|244|O|Symptoms of overdose may include: severe drowsiness,||
6274|245|O|unusual/uncontrolled movements.||
6274|246|B|||
6274|247|N|NOTES:  Do not share this medication with others.||
6274|248|N|   Lab and/or medical tests (such as blood mineral levels, blood||
6274|249|N|sugar, EKG) should be done while you are taking this medication.||
6274|250|N|Keep all medical and lab appointments. Consult your doctor for||
6274|251|N|more details.||
6274|252|B|||
6274|253|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6274|254|D|remember. If it is near the time of the next dose, skip the||
6274|255|D|missed dose. Take your next dose at the regular time. Do not||
6274|256|D|double the dose to catch up.||
6274|257|B|||
6274|258|R|STORAGE:  Store at room temperature away from light and moisture.||
6274|259|R|Do not store in the bathroom. Keep all medications away from||
6274|260|R|children and pets.||
6274|261|R|   Do not flush medications down the toilet or pour them into a||
6274|262|R|drain unless instructed to do so. Properly discard this product||
6274|263|R|when it is expired or no longer needed. Consult your pharmacist||
6274|264|R|or local waste disposal company.||
6274|265|B|||
6274|266|A|Information last revised February 2025.||
6274|267|A|Copyright(c) 2025 First Databank, Inc.||
6274|268|B|||
6276|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6276|002|Z|does NOT have all possible information about this product. This||
6276|003|Z|information does not assure that this product is safe, effective,||
6276|004|Z|or appropriate for you. This information is not individual||
6276|005|Z|medical advice and does not substitute for the advice of your||
6276|006|Z|health care professional. Always ask your health care||
6276|007|Z|professional for complete information about this product and your||
6276|008|Z|specific health needs.||
6276|009|B|||
6276|010|T|DILTIAZEM EXTENDED-RELEASE TABLET - ORAL||
6276|011|F|(dil-TYE-a-zem)||
6276|012|B|||
6276|013|C|COMMON BRAND NAME(S): Cardizem LA||
6276|014|B|||
6276|015|U|USES:  Diltiazem is used to treat high blood pressure||
6276|016|U|(hypertension) and prevent chest pain (angina). Lowering high||
6276|017|U|blood pressure helps prevent strokes, heart attacks, and kidney||
6276|018|U|problems. When used regularly, diltiazem can decrease the number||
6276|019|U|and severity of episodes of chest pain from angina. It may help||
6276|020|U|increase your ability to exercise.||
6276|021|U|   Diltiazem is called a calcium channel blocker. It works by||
6276|022|U|relaxing blood vessels in the body and heart so blood can flow||
6276|023|U|more easily. Diltiazem also lowers your heart rate. These effects||
6276|024|U|help the heart work less hard and lower blood pressure.||
6276|025|B|||
6276|026|V|OTHER USES:  This section contains uses of this drug that are not||
6276|027|V|listed in the approved professional labeling for the drug but||
6276|028|V|that may be prescribed by your health care professional. Use this||
6276|029|V|drug for a condition that is listed in this section only if it||
6276|030|V|has been so prescribed by your health care professional.||
6276|031|V|   Diltiazem may also be used to control your heart rate if you||
6276|032|V|have a fast/irregular heartbeat (such as atrial fibrillation).||
6276|033|B|||
6276|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6276|035|H|from your pharmacist before you start taking diltiazem and each||
6276|036|H|time you get a refill. If you have any questions, ask your doctor||
6276|037|H|or pharmacist.||
6276|038|H|   Take this medication by mouth with or without food as directed||
6276|039|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
6276|040|H|not crush or chew the tablets. Doing so can release all of the||
6276|041|H|drug at once, increasing the risk of side effects. Depending on||
6276|042|H|your specific brand, take this medication either in the morning||
6276|043|H|or at bedtime as directed. Consult your pharmacist if you have||
6276|044|H|any questions about when to take the medication.||
6276|045|H|   Your doctor may gradually increase your dose. Follow your||
6276|046|H|doctor's instructions carefully. The dosage is based on your||
6276|047|H|medical condition, response to treatment, and other medications||
6276|048|H|you may be taking. Be sure to tell your doctor and pharmacist||
6276|049|H|about all the products you use (including prescription drugs,||
6276|050|H|nonprescription drugs, and herbal products).||
6276|051|H|   Use this medication regularly to get the most benefit from it.||
6276|052|H|To help you remember, use it at the same time each day. Keep||
6276|053|H|taking this medication even if you feel well. Most people with||
6276|054|H|high blood pressure do not feel sick. For the treatment of high||
6276|055|H|blood pressure, it may take 2 weeks before you get the full||
6276|056|H|benefit of this drug.||
6276|057|H|   This medication must be taken regularly to prevent angina. It||
6276|058|H|should not be used to treat angina when it occurs. Use other||
6276|059|H|medications (such as nitroglycerin placed under the tongue) to||
6276|060|H|relieve an angina attack as directed by your doctor. Consult your||
6276|061|H|doctor or pharmacist for details.||
6276|062|H|   Tell your doctor if your condition does not get better or if||
6276|063|H|it gets worse (for example, your blood pressure readings remain||
6276|064|H|high or increase, your chest pain worsens).||
6276|065|B|||
6276|066|S|SIDE EFFECTS:  Dizziness, lightheadedness, weakness, nausea,||
6276|067|S|flushing, constipation, and headache may occur. If any of these||
6276|068|S|effects last or get worse, tell your doctor or pharmacist||
6276|069|S|promptly.||
6276|070|S|   To reduce the risk of dizziness and lightheadedness, get up||
6276|071|S|slowly when rising from a sitting or lying position.||
6276|072|S|   Remember that this medication has been prescribed because your||
6276|073|S|doctor has judged that the benefit to you is greater than the||
6276|074|S|risk of side effects. Many people using this medication do not||
6276|075|S|have serious side effects.||
6276|076|S|   Tell your doctor right away if you have any serious side||
6276|077|S|effects, including: nausea/vomiting that doesn't stop, fainting,||
6276|078|S|new or worsening symptoms of heart failure (such as shortness of||
6276|079|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
6276|080|S|weight gain), slow/irregular/pounding/fast heartbeat, mental/mood||
6276|081|S|changes (such as depression, agitation), unusual dreams, severe||
6276|082|S|stomach/abdominal pain, severe constipation, dark urine,||
6276|083|S|yellowing eyes/skin.||
6276|084|S|   A very serious allergic reaction to this drug is rare.||
6276|085|S|However, get medical help right away if you notice any symptoms||
6276|086|S|of a serious allergic reaction, including: rash, itching/swelling||
6276|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6276|088|S|breathing.||
6276|089|S|   This is not a complete list of possible side effects. If you||
6276|090|S|notice other effects not listed above, contact your doctor or||
6276|091|S|pharmacist.||
6276|092|S|   In the US -||
6276|093|S|   Call your doctor for medical advice about side effects. You||
6276|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6276|095|S|www.fda.gov/medwatch.||
6276|096|S|   In Canada - Call your doctor for medical advice about side||
6276|097|S|effects. You may report side effects to Health Canada at||
6276|098|S|1-866-234-2345.||
6276|099|B|||
6276|100|P|PRECAUTIONS:  Before taking diltiazem, tell your doctor or||
6276|101|P|pharmacist if you are allergic to it; or if you have any other||
6276|102|P|allergies. This product may contain inactive ingredients, which||
6276|103|P|can cause allergic reactions or other problems. Talk to your||
6276|104|P|pharmacist for more details.||
6276|105|P|   Before using this medication, tell your doctor or pharmacist||
6276|106|P|your medical history, especially of: certain types of heart||
6276|107|P|rhythm problems (such as sick sinus syndrome/atrioventricular||
6276|108|P|block), liver disease, kidney disease, heart failure, narrowing||
6276|109|P|of any part of the stomach/intestines.||
6276|110|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6276|111|P|can make you more dizzy. Do not drive, use machinery, or do||
6276|112|P|anything that needs alertness until you can do it safely. Limit||
6276|113|P|alcoholic beverages. Talk to your doctor if you are using||
6276|114|P|marijuana (cannabis).||
6276|115|P|   Before having surgery, tell your doctor or dentist about all||
6276|116|P|the products you use (including prescription drugs,||
6276|117|P|nonprescription drugs, and herbal products).||
6276|118|P|   Older adults may be more sensitive to the side effects of this||
6276|119|P|drug, especially dizziness, constipation, or swelling||
6276|120|P|ankles/feet.||
6276|121|P|   During pregnancy, this medication should be used only when||
6276|122|P|clearly needed. Discuss the risks and benefits with your doctor.||
6276|123|P|   This drug passes into breast milk and may have undesirable||
6276|124|P|effects on a nursing infant. Consult your doctor before||
6276|125|P|breastfeeding.||
6276|126|B|||
6276|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6276|128|I|medications work or increase your risk for serious side effects.||
6276|129|I|This document does not contain all possible drug interactions.||
6276|130|I|Keep a list of all the products you use (including||
6276|131|I|prescription/nonprescription drugs and herbal products) and share||
6276|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
6276|133|I|the dosage of any medicines without your doctor's approval.||
6276|134|I|   Some products that may interact with this drug include:||
6276|135|I|digoxin, fingolimod, labetalol.||
6276|136|I|   Other medications can affect the removal of diltiazem from||
6276|137|I|your body, which may affect how this medication works. Examples||
6276|138|I|include azole antifungals (such as ketoconazole), cimetidine,||
6276|139|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
6276|140|I|rifabutin, rifampin), St. John's wort, among others.||
6276|141|I|   This medication can slow down the removal of other medications||
6276|142|I|from your body, which may affect how they work. Examples of||
6276|143|I|affected drugs include aprepitant/fosaprepitant, buspirone,||
6276|144|I|colchicine, elacestrant, flibanserin, ivabradine, lomitapide,||
6276|145|I|certain benzodiazepines (triazolam, midazolam), among others.||
6276|146|I|   Some products have ingredients that could raise your heart||
6276|147|I|rate or blood pressure. Tell your pharmacist what products you||
6276|148|I|are using, and ask how to use them safely (especially||
6276|149|I|cough-and-cold products, diet aids, or NSAIDs such as||
6276|150|I|ibuprofen/naproxen).||
6276|151|B|||
6276|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6276|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6276|154|O|poison control center right away. US residents can call||
6276|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6276|156|B|||
6276|157|N|NOTES:  Do not share this medication with others.||
6276|158|N|   Lifestyle changes such as stress reduction programs, exercise,||
6276|159|N|and dietary changes may increase the effectiveness of this||
6276|160|N|medicine. Talk to your doctor or pharmacist about lifestyle||
6276|161|N|changes that might benefit you.||
6276|162|N|   Lab and/or medical tests (such as kidney/liver function,||
6276|163|N|pulse, blood pressure, EKG) may be done while you are taking this||
6276|164|N|medication. Keep all medical and lab appointments. Consult your||
6276|165|N|doctor for more details.||
6276|166|N|   There are different brands and types of this medication||
6276|167|N|available. Many do not have the same effects. Do not change||
6276|168|N|brands or types without consulting your doctor or pharmacist.||
6276|169|N|   Have your blood pressure checked regularly while taking this||
6276|170|N|medication. Learn how to monitor your own blood pressure at home,||
6276|171|N|and share the results with your doctor.||
6276|172|B|||
6276|173|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6276|174|D|remember. If it is near the time of the next dose, skip the||
6276|175|D|missed dose. Take your next dose at the regular time. Do not||
6276|176|D|double the dose to catch up.||
6276|177|B|||
6276|178|R|STORAGE:  Store at room temperature away from light and moisture.||
6276|179|R|Do not store in the bathroom. Keep all medications away from||
6276|180|R|children and pets.||
6276|181|R|   Do not flush medications down the toilet or pour them into a||
6276|182|R|drain unless instructed to do so. Properly discard this product||
6276|183|R|when it is expired or no longer needed. Consult your pharmacist||
6276|184|R|or local waste disposal company.||
6276|185|B|||
6276|186|M|MEDICAL ALERT:  Your condition can cause complications in a||
6276|187|M|medical emergency. For information about enrolling in MedicAlert,||
6276|188|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6276|189|B|||
6276|190|A|Information last revised March 2025.||
6276|191|A|Copyright(c) 2025 First Databank, Inc.||
6276|192|B|||
6277|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6277|002|Z|does NOT have all possible information about this product. This||
6277|003|Z|information does not assure that this product is safe, effective,||
6277|004|Z|or appropriate for you. This information is not individual||
6277|005|Z|medical advice and does not substitute for the advice of your||
6277|006|Z|health care professional. Always ask your health care||
6277|007|Z|professional for complete information about this product and your||
6277|008|Z|specific health needs.||
6277|009|B|||
6277|010|T|MONTELUKAST GRANULES - ORAL||
6277|011|F|(MON-te-LOO-kast)||
6277|012|B|||
6277|013|C|COMMON BRAND NAME(S): Singulair||
6277|014|B|||
6277|015|W|WARNING:  This medication may rarely cause serious mental/mood||
6277|016|W|changes. These effects may occur even after the medication has||
6277|017|W|been stopped. Tell your doctor right away if you or a||
6277|018|W|caregiver/family member notice symptoms such as agitation,||
6277|019|W|anxiety, abnormal dreams, depression, memory/attention problems,||
6277|020|W|hallucinations, trouble sleeping, or changes in behavior (such as||
6277|021|W|aggression, hostility, restlessness, sleepwalking, suicidal||
6277|022|W|thoughts/attempts). Talk to your doctor about the risks and||
6277|023|W|benefits of this medication.||
6277|024|B|||
6277|025|U|USES:  Montelukast is used to control and prevent symptoms caused||
6277|026|U|by asthma (such as wheezing and shortness of breath). It is also||
6277|027|U|used before exercise to prevent breathing problems during||
6277|028|U|exercise (bronchospasm). This medication can help decrease the||
6277|029|U|number of times you need to use your quick relief inhaler.||
6277|030|U|   Montelukast is also used to relieve symptoms of hay fever and||
6277|031|U|allergic rhinitis (such as sneezing, stuffy/runny/itchy nose).||
6277|032|U|Since there are other allergy medications that may be safer (see||
6277|033|U|also Warning section), this medication should be used for this||
6277|034|U|condition only when you cannot take other allergy medications or||
6277|035|U|they do not work well.||
6277|036|U|   This medication must be used regularly to be effective. It||
6277|037|U|does not work right away and should not be used to relieve sudden||
6277|038|U|asthma attacks or breathing problems. If an asthma attack or||
6277|039|U|sudden shortness of breath occurs, use your quick-relief inhaler||
6277|040|U|as prescribed.||
6277|041|U|   This drug works by blocking certain natural substances||
6277|042|U|(leukotrienes) that may cause or worsen asthma and allergies. It||
6277|043|U|helps make breathing easier by reducing swelling (inflammation)||
6277|044|U|in the airways.||
6277|045|B|||
6277|046|H|HOW TO USE:  Read the Medication Guide provided by your||
6277|047|H|pharmacist before you start taking montelukast and each time you||
6277|048|H|get a refill. If you have any questions, ask your doctor or||
6277|049|H|pharmacist.||
6277|050|H|   Take this medication by mouth with or without food as directed||
6277|051|H|by your doctor. The dosage is based on your age and medical||
6277|052|H|condition.||
6277|053|H|   You may swallow your dose plain, dissolve it in certain||
6277|054|H|liquids, or mix it with a spoonful of soft food (such as||
6277|055|H|applesauce) before swallowing. After opening the foil packet,||
6277|056|H|take your dose within 15 minutes.||
6277|057|H|   If you are mixing the granules in liquid, empty the packet||
6277|058|H|into a small cup with 1 teaspoon (5 milliliters) of baby formula||
6277|059|H|or breast milk (cool or at room temperature). Do not mix with||
6277|060|H|water or other liquids. Stir well, and take the entire mixture||
6277|061|H|right away. Do not save it for later use. After taking the liquid||
6277|062|H|mixture, you may drink other liquids if desired.||
6277|063|H|   If you are mixing the granules in soft food, mix only with the||
6277|064|H|following foods: applesauce, mashed carrots, rice, or ice cream.||
6277|065|H|Empty the packet into a small cup with 1 spoonful of soft food||
6277|066|H|(cool or at room temperature) and mix completely. Take all of the||
6277|067|H|mixture right away. Do not save it for later use.||
6277|068|H|   Take this medication at the same time each day. If you are||
6277|069|H|taking this medication for asthma or for both asthma and||
6277|070|H|allergies, take your dose in the evening. If you are taking||
6277|071|H|montelukast to prevent only allergies, take your dose either in||
6277|072|H|the morning or the evening.||
6277|073|H|   If you are taking this medication to prevent breathing||
6277|074|H|problems during exercise, take your dose at least 2 hours before||
6277|075|H|exercise. Do not take more than one dose in 24 hours. Do not take||
6277|076|H|a dose before exercise if you are already taking this medication||
6277|077|H|daily for asthma or allergies. Doing so may increase the risk of||
6277|078|H|side effects.||
6277|079|H|   Do not increase or decrease your dose or stop using this||
6277|080|H|medication without consulting your doctor. Continue to use this||
6277|081|H|medication regularly to keep your asthma under control, even||
6277|082|H|during sudden asthma attacks or periods when you have no asthma||
6277|083|H|symptoms. Continue to also take other medications for asthma as||
6277|084|H|directed by your doctor.||
6277|085|H|   This medication works over time and is not meant to relieve||
6277|086|H|sudden attacks of asthma. If an asthma attack or other breathing||
6277|087|H|problem occurs, use your quick-relief inhaler as prescribed. You||
6277|088|H|should always have a quick-relief inhaler with you.||
6277|089|H|   Learn which of your medications you should use every day and||
6277|090|H|which you should use if your breathing suddenly worsens. Ask your||
6277|091|H|doctor what to do if you have worsening cough or shortness of||
6277|092|H|breath, wheezing, increased sputum, worsening peak flow meter||
6277|093|H|readings, increased use of your quick-relief inhaler, or if your||
6277|094|H|quick-relief inhaler does not seem to be working well. Learn when||
6277|095|H|you can self-medicate and when you should get medical help right||
6277|096|H|away.||
6277|097|B|||
6277|098|S|SIDE EFFECTS:  See also Warning section.||
6277|099|S|   Remember that this medication has been prescribed because your||
6277|100|S|doctor has judged that the benefit to you is greater than the||
6277|101|S|risk of side effects. Many people using this medication do not||
6277|102|S|have serious side effects.||
6277|103|S|   Tell your doctor right away if you have any serious side||
6277|104|S|effects, including: numbness/tingling/shooting pain in the arms||
6277|105|S|or legs, sinus pain/swelling, muscle weakness, uncontrolled||
6277|106|S|muscle movements, stuttering.||
6277|107|S|   A very serious allergic reaction to this drug is rare.||
6277|108|S|However, get medical help right away if you notice any symptoms||
6277|109|S|of a serious allergic reaction, including: rash, itching/swelling||
6277|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6277|111|S|breathing.||
6277|112|S|   This is not a complete list of possible side effects. If you||
6277|113|S|notice other effects not listed above, contact your doctor or||
6277|114|S|pharmacist.||
6277|115|S|   In the US -||
6277|116|S|   Call your doctor for medical advice about side effects. You||
6277|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6277|118|S|www.fda.gov/medwatch.||
6277|119|S|   In Canada - Call your doctor for medical advice about side||
6277|120|S|effects. You may report side effects to Health Canada at||
6277|121|S|1-866-234-2345.||
6277|122|B|||
6277|123|P|PRECAUTIONS:  Before taking montelukast, tell your doctor or||
6277|124|P|pharmacist if you are allergic to it; or if you have any other||
6277|125|P|allergies. This product may contain inactive ingredients, which||
6277|126|P|can cause allergic reactions or other problems. Talk to your||
6277|127|P|pharmacist for more details.||
6277|128|P|   Before using this drug, tell your doctor or pharmacist your||
6277|129|P|medical history, especially of: liver disease, mental/mood||
6277|130|P|problems (such as anxiety, depression, thoughts of suicide).||
6277|131|P|   Before having surgery, tell your doctor or dentist about all||
6277|132|P|the products you use (including prescription drugs,||
6277|133|P|nonprescription drugs, and herbal products).||
6277|134|P|   During pregnancy, this medication should be used only when||
6277|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
6277|136|P|   This medication passes into breast milk. Consult your doctor||
6277|137|P|before breastfeeding.||
6277|138|B|||
6277|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6277|140|I|medications work or increase your risk for serious side effects.||
6277|141|I|This document does not contain all possible drug interactions.||
6277|142|I|Keep a list of all the products you use (including||
6277|143|I|prescription/nonprescription drugs and herbal products) and share||
6277|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
6277|145|I|the dosage of any medicines without your doctor's approval.||
6277|146|B|||
6277|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6277|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6277|149|O|poison control center right away. US residents can call||
6277|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6277|151|O|Symptoms of overdose may include: thirst, drowsiness, inability||
6277|152|O|to keep still, vomiting, or severe stomach pain.||
6277|153|B|||
6277|154|N|NOTES:  Do not share this medication with others.||
6277|155|N|   Lab and/or medical tests (such as lung function) should be||
6277|156|N|done while you are taking this medication. Keep all medical and||
6277|157|N|lab appointments. Consult your doctor for more details.||
6277|158|B|||
6277|159|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
6277|160|D|next dose at the regular time. Do not double the dose to catch||
6277|161|D|up. Do not take more than 1 dose in 24 hours.||
6277|162|B|||
6277|163|R|STORAGE:  Store at room temperature away from light and moisture.||
6277|164|R|Do not store in the bathroom. Keep all medications away from||
6277|165|R|children and pets.||
6277|166|R|   Do not flush medications down the toilet or pour them into a||
6277|167|R|drain unless instructed to do so. Properly discard this product||
6277|168|R|when it is expired or no longer needed. Consult your pharmacist||
6277|169|R|or local waste disposal company.||
6277|170|B|||
6277|171|M|MEDICAL ALERT:  Your condition can cause complications in a||
6277|172|M|medical emergency. For information about enrolling in MedicAlert,||
6277|173|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6277|174|B|||
6277|175|A|Information last revised May 2024.||
6277|176|A|Copyright(c) 2025 First Databank, Inc.||
6277|177|B|||
6279|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6279|002|Z|does NOT have all possible information about this product. This||
6279|003|Z|information does not assure that this product is safe, effective,||
6279|004|Z|or appropriate for you. This information is not individual||
6279|005|Z|medical advice and does not substitute for the advice of your||
6279|006|Z|health care professional. Always ask your health care||
6279|007|Z|professional for complete information about this product and your||
6279|008|Z|specific health needs.||
6279|009|B|||
6279|010|T|ZANAMIVIR INHALER - ORAL INHALATION||
6279|011|F|(za-NAM-i-vir)||
6279|012|B|||
6279|013|C|COMMON BRAND NAME(S): Relenza||
6279|014|B|||
6279|015|U|USES:  Zanamivir is used to treat symptoms caused by the flu||
6279|016|U|virus (influenza) if you have had symptoms for 2 days or less. It||
6279|017|U|helps lessen symptoms (such as stuffy nose, cough, sore throat,||
6279|018|U|fever/chills, headache, body aches, tiredness) and shortens the||
6279|019|U|recovery time by about 1 to 2 days.||
6279|020|U|   Zanamivir may also be used to prevent the flu if you have been||
6279|021|U|exposed to someone who already has the flu (such as a sick||
6279|022|U|household member) or if there is a flu outbreak in the community.||
6279|023|U|Talk to your doctor for more details.||
6279|024|U|   This medication works by stopping the flu virus from growing.||
6279|025|U|It is not a substitute for the flu vaccine.||
6279|026|U|   If you have the flu, zanamivir does not reduce the risk of||
6279|027|U|giving the flu to others.||
6279|028|B|||
6279|029|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
6279|030|H|your pharmacist before you start using zanamivir and each time||
6279|031|H|you get a refill. Learn all usage instructions. If you have any||
6279|032|H|questions, ask your doctor or pharmacist.||
6279|033|H|   For flu treatment: inhale this medication through your mouth||
6279|034|H|as directed by your doctor, usually 2 inhalations (1 blister per||
6279|035|H|inhalation) twice a day (about 12 hours apart) for 5 days. If||
6279|036|H|possible, on the first day of treatment, take two doses (2||
6279|037|H|inhalations each), waiting at least 2 hours between doses.||
6279|038|H|   For flu prevention: inhale this medication through your mouth||
6279|039|H|as directed by your doctor, usually 2 inhalations (1 blister per||
6279|040|H|inhalation) once a day. The usual length of time you will take||
6279|041|H|zanamivir is 10 days if there is a sick household member or 28||
6279|042|H|days if there is a flu outbreak in the community, or as directed||
6279|043|H|by your doctor.||
6279|044|H|   Remove the cover on the disk inhaler. Before use, check the||
6279|045|H|mouthpiece to be sure it is clean and free of particles. Load the||
6279|046|H|medication disk into the disk inhaler. Puncture one medication||
6279|047|H|blister. Keep the disk inhaler level so that the medication will||
6279|048|H|not spill out. Breathe out all the way through your mouth, put||
6279|049|H|the mouthpiece into your mouth, and breathe in through your mouth||
6279|050|H|as deeply as you can. This will draw the medication into your||
6279|051|H|lungs. Hold your breath for a few seconds. To take another||
6279|052|H|inhalation, advance to the next medication blister and repeat the||
6279|053|H|process. Replace the cover of the disk inhaler.||
6279|054|H|   Do not mix this powder medication with any liquids, including||
6279|055|H|nebulizer liquids.||
6279|056|H|   If a child is using this medication, a parent or other||
6279|057|H|responsible adult should supervise the child to make sure it is||
6279|058|H|used properly.||
6279|059|H|   Start zanamivir as soon as possible. This medication works||
6279|060|H|best when the amount of medicine in your body is kept at a||
6279|061|H|constant level. Use this drug at evenly spaced intervals at the||
6279|062|H|same time(s) every day.||
6279|063|H|   Continue to use this medication for the full time prescribed,||
6279|064|H|even if symptoms improve. Stopping the medication too early may||
6279|065|H|result in a return of the infection, or failure to protect you||
6279|066|H|from the flu.||
6279|067|H|   If you have breathing problems (such as asthma, chronic||
6279|068|H|obstructive pulmonary disease-COPD) and are scheduled to use||
6279|069|H|inhaled bronchodilators (such as albuterol) at the same time as||
6279|070|H|zanamivir, use the bronchodilator medication before using||
6279|071|H|zanamivir. Ask your doctor or pharmacist for more details.||
6279|072|H|   Tell your doctor if your condition lasts or gets worse or if||
6279|073|H|new symptoms appear.||
6279|074|B|||
6279|075|S|SIDE EFFECTS:  Dizziness may occur. Also, because this medication||
6279|076|S|is an inhaled powder, you may experience increased coughing after||
6279|077|S|using it. If either of these effects lasts or gets worse, tell||
6279|078|S|your doctor or pharmacist promptly.||
6279|079|S|   Remember that this medication has been prescribed because your||
6279|080|S|doctor has judged that the benefit to you is greater than the||
6279|081|S|risk of side effects. Many people using this medication do not||
6279|082|S|have serious side effects.||
6279|083|S|   This medication can cause breathing problems, which in rare||
6279|084|S|cases can be fatal. If you experience trouble breathing such as||
6279|085|S|wheezing or shortness of breath, stop using zanamivir and get||
6279|086|S|medical help right away. Zanamivir is not recommended if you have||
6279|087|S|lung/breathing problems. Discuss the risks and benefits with your||
6279|088|S|doctor. However, if your doctor decides you should use zanamivir,||
6279|089|S|have a quick-relief inhaled bronchodilator (such as albuterol||
6279|090|S|inhaler) readily available.||
6279|091|S|   The flu itself or zanamivir may rarely cause serious||
6279|092|S|mental/mood changes. This may be more likely in children. Tell||
6279|093|S|your doctor right away of any signs of unusual behavior,||
6279|094|S|including confusion, agitation, self-injury.||
6279|095|S|   A very serious allergic reaction to this drug is rare.||
6279|096|S|However, get medical help right away if you notice any symptoms||
6279|097|S|of a serious allergic reaction, including: rash, itching/swelling||
6279|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6279|099|S|breathing.||
6279|100|S|   This is not a complete list of possible side effects. If you||
6279|101|S|notice other effects not listed above, contact your doctor or||
6279|102|S|pharmacist.||
6279|103|S|   In the US -||
6279|104|S|   Call your doctor for medical advice about side effects. You||
6279|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6279|106|S|www.fda.gov/medwatch.||
6279|107|S|   In Canada - Call your doctor for medical advice about side||
6279|108|S|effects. You may report side effects to Health Canada at||
6279|109|S|1-866-234-2345.||
6279|110|B|||
6279|111|P|PRECAUTIONS:  Before using zanamivir, tell your doctor or||
6279|112|P|pharmacist if you are allergic to it; or if you have any other||
6279|113|P|allergies. This product may contain inactive ingredients (such as||
6279|114|P|lactose, milk proteins), which can cause allergic reactions or||
6279|115|P|other problems. Talk to your pharmacist for more details.||
6279|116|P|   Before using this medication, tell your doctor or pharmacist||
6279|117|P|your medical history, especially of: lung or breathing problems||
6279|118|P|(such as asthma, chronic obstructive pulmonary disease-COPD).||
6279|119|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6279|120|P|can make you more dizzy. Do not drive, use machinery, or do||
6279|121|P|anything that needs alertness until you can do it safely. Limit||
6279|122|P|alcoholic beverages. Talk to your doctor if you are using||
6279|123|P|marijuana (cannabis).||
6279|124|P|   Before having surgery, tell your doctor or dentist about all||
6279|125|P|the products you use (including prescription drugs,||
6279|126|P|nonprescription drugs, and herbal products).||
6279|127|P|   This drug may be less effective for young children. They may||
6279|128|P|be unable to breathe in deeply enough using this inhaler device||
6279|129|P|to get enough drug to benefit them.||
6279|130|P|   During pregnancy, this medication should be used only when||
6279|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
6279|132|P|   It is unknown if this drug passes into breast milk. Consult||
6279|133|P|your doctor before breastfeeding.||
6279|134|B|||
6279|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6279|136|I|medications work or increase your risk for serious side effects.||
6279|137|I|This document does not contain all possible drug interactions.||
6279|138|I|Keep a list of all the products you use (including||
6279|139|I|prescription/nonprescription drugs and herbal products) and share||
6279|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
6279|141|I|the dosage of any medicines without your doctor's approval.||
6279|142|I|   Tell your doctor if you have received flu vaccine in the nose||
6279|143|I|in the past 2 weeks. If given too closely together, zanamivir may||
6279|144|I|interfere with the protection from flu vaccine given in the nose.||
6279|145|I|Wait at least 2 days after the end of zanamivir treatment before||
6279|146|I|receiving flu vaccine given in the nose.||
6279|147|B|||
6279|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6279|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6279|150|O|poison control center right away. US residents can call||
6279|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6279|152|B|||
6279|153|N|NOTES:  Do not share this medication with others.||
6279|154|N|   This medication has been prescribed for your current condition||
6279|155|N|only. Do not use it later for another infection unless your||
6279|156|N|doctor tells you to.||
6279|157|N|   This medication is not a substitute for the flu vaccine.||
6279|158|N|Consult your doctor about the risks and important benefits of||
6279|159|N|receiving a yearly flu shot to lower your chances of getting the||
6279|160|N|flu.||
6279|161|B|||
6279|162|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6279|163|D|If it is within 2 hours of the next dose, skip the missed dose.||
6279|164|D|Use your next dose at the regular time. Do not double the dose to||
6279|165|D|catch up.||
6279|166|B|||
6279|167|R|STORAGE:  Store at room temperature away from moisture. Do not||
6279|168|R|puncture the foil blister until you are ready to take your dose.||
6279|169|R|Do not store in the bathroom. Keep all medications away from||
6279|170|R|children and pets.||
6279|171|R|   Do not flush medications down the toilet or pour them into a||
6279|172|R|drain unless instructed to do so. Properly discard this product||
6279|173|R|when it is expired or no longer needed. Consult your pharmacist||
6279|174|R|or local waste disposal company.||
6279|175|B|||
6279|176|A|Information last revised March 2025.||
6279|177|A|Copyright(c) 2025 First Databank, Inc.||
6279|178|B|||
6280|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6280|002|Z|does NOT have all possible information about this product. This||
6280|003|Z|information does not assure that this product is safe, effective,||
6280|004|Z|or appropriate for you. This information is not individual||
6280|005|Z|medical advice and does not substitute for the advice of your||
6280|006|Z|health care professional. Always ask your health care||
6280|007|Z|professional for complete information about this product and your||
6280|008|Z|specific health needs.||
6280|009|B|||
6280|010|T|NORETHINDRONE/ETHINYL ESTRADIOL/FERROUS FUMARATE - ORAL||
6280|011|F|(nor-ETH-in-drone/ETH-i-nil ES-tra-DYE-ol/FER-us FUE-ma-rate)||
6280|012|B|||
6280|013|C|COMMON BRAND NAME(S): Estrostep Fe, Loestrin Fe||
6280|014|B|||
6280|015|W|WARNING:  Do not use this medication if you smoke cigarettes/use||
6280|016|W|tobacco and are over 35 years old. Smoking raises your risk of||
6280|017|W|stroke, heart attack, blood clots, and high blood pressure from||
6280|018|W|hormonal birth control (such as the pill, patch, ring). The risk||
6280|019|W|of these serious problems increases with age and with the number||
6280|020|W|of cigarettes you smoke. Do not smoke or use tobacco.||
6280|021|W|   Accidental overdose of iron-containing products is a leading||
6280|022|W|cause of fatal poisoning in children younger than 6 years. Keep||
6280|023|W|this product out of reach of children. If overdose does occur,||
6280|024|W|get medical help right away or call a poison control center.||
6280|025|B|||
6280|026|U|USES:  This combination hormone medication is used to prevent||
6280|027|U|pregnancy. It contains 2 hormones: norethindrone (a progestin)||
6280|028|U|and ethinyl estradiol (an estrogen). There is a small amount of||
6280|029|U|iron (ferrous fumarate) in each of the 7 inactive tablets taken||
6280|030|U|during the fourth week. The inactive pills do not contain any||
6280|031|U|hormones. These tablets are meant to keep you in the habit of||
6280|032|U|taking 1 tablet each day and do not have enough iron to treat||
6280|033|U|iron deficiency.||
6280|034|U|   Besides preventing pregnancy, birth control pills may make||
6280|035|U|your periods more regular, decrease blood loss and painful||
6280|036|U|periods, decrease your risk of ovarian cysts, and also treat||
6280|037|U|acne.||
6280|038|U|   This medication does not protect against sexually transmitted||
6280|039|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
6280|040|U|an effective barrier method (latex or polyurethane condom/dental||
6280|041|U|dams) during sexual activity will help to decrease your risk of||
6280|042|U|infection.||
6280|043|B|||
6280|044|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
6280|045|H|your pharmacist before you start using this product and each time||
6280|046|H|you get a refill. The leaflet contains very important information||
6280|047|H|on when to take your pills and what to do if you miss a dose. If||
6280|048|H|you have any questions, ask your doctor or pharmacist.||
6280|049|H|   Take this medication by mouth as directed by your doctor,||
6280|050|H|usually once daily. Pick a time of day that is easy for you to||
6280|051|H|remember, and take your pill at the same time each day.||
6280|052|H|   If you are taking the chewable tablet, you may either swallow||
6280|053|H|it whole or chew it thoroughly and swallow.||
6280|054|H|   It is very important to keep taking this medication exactly as||
6280|055|H|prescribed by your doctor. Follow the package instructions to||
6280|056|H|find the first tablet, start with the first tablet in the pack,||
6280|057|H|and take them in the correct order. Do not skip any doses.||
6280|058|H|Pregnancy is more likely if you miss pills, start a new pack||
6280|059|H|late, or take your pill at a different time of the day than||
6280|060|H|usual.||
6280|061|H|   Vomiting or diarrhea can prevent your birth control pills from||
6280|062|H|working well. If you have vomiting or diarrhea, you may need to||
6280|063|H|use a backup birth control method (such as condoms, spermicide).||
6280|064|H|Follow the directions in the Patient Information Leaflet and||
6280|065|H|check with your doctor or pharmacist for more details.||
6280|066|H|   Taking this medication after your evening meal or at bedtime||
6280|067|H|may help if you have any stomach upset or nausea with the||
6280|068|H|medication. You may choose to take this medication at another||
6280|069|H|time of day that is easier for you to remember. No matter what||
6280|070|H|dosing schedule you use, it is very important that you take this||
6280|071|H|medication at the same time each day, 24 hours apart. Ask your||
6280|072|H|doctor or pharmacist if you have any questions.||
6280|073|H|   Your pill pack contains 21 pills with active medication. It||
6280|074|H|also contains 7 reminder pills with iron. Take one active pill||
6280|075|H|(with hormones) once daily for 21 days in a row. Take one||
6280|076|H|inactive pill (with iron) once daily for 7 days in a row after||
6280|077|H|you have taken the last active pill unless otherwise directed by||
6280|078|H|your doctor. You should have your period during the fourth week||
6280|079|H|of the pack. After you have taken the last iron tablet in the||
6280|080|H|pack, start a new pack the next day whether or not you have your||
6280|081|H|period. If you do not get your period, consult your doctor.||
6280|082|H|   If this is the first time you are using this medication and||
6280|083|H|you are not switching from another form of hormonal birth control||
6280|084|H|(such as patch, other birth control pills), take the first tablet||
6280|085|H|in the pack on the first Sunday following the beginning of your||
6280|086|H|menstrual period or on the first day of your period. If your||
6280|087|H|period begins on a Sunday, begin taking this medication on that||
6280|088|H|day. For the first cycle of use only, use a backup form of||
6280|089|H|non-hormonal birth control (such as condoms, spermicide) for the||
6280|090|H|first 7 days to prevent pregnancy until the medication has enough||
6280|091|H|time to work. If you start on the first day of your period, you||
6280|092|H|do not need to use backup birth control the first week.||
6280|093|H|   Ask your doctor or pharmacist for information about how to||
6280|094|H|switch from other forms of hormonal birth control (such as patch,||
6280|095|H|other birth control pills) to this product. If any information is||
6280|096|H|unclear, consult the Patient Information Leaflet or your doctor||
6280|097|H|or pharmacist.||
6280|098|B|||
6280|099|S|SIDE EFFECTS:  Nausea, vomiting, headache, bloating, breast||
6280|100|S|tenderness, swelling of the ankles/feet (fluid retention), or||
6280|101|S|weight change may occur. Vaginal bleeding between periods||
6280|102|S|(spotting) or missed/irregular periods may occur, especially||
6280|103|S|during the first few months of use. If any of these effects last||
6280|104|S|or get worse, tell your doctor or pharmacist promptly. If you||
6280|105|S|miss 2 periods in a row (or 1 period if the pill has not been||
6280|106|S|used properly), contact your doctor for a pregnancy test.||
6280|107|S|   Remember that this medication has been prescribed because your||
6280|108|S|doctor has judged that the benefit to you is greater than the||
6280|109|S|risk of side effects. Many people using this medication do not||
6280|110|S|have serious side effects.||
6280|111|S|   This medication may raise your blood pressure. Check your||
6280|112|S|blood pressure regularly and tell your doctor if the results are||
6280|113|S|high.||
6280|114|S|   Tell your doctor right away if you have any serious side||
6280|115|S|effects, including: lumps in the breast, mental/mood changes||
6280|116|S|(such as new/worsening depression), severe stomach/abdominal||
6280|117|S|pain, unusual changes in vaginal bleeding (such as continuous||
6280|118|S|spotting, sudden heavy bleeding, missed periods), dark urine,||
6280|119|S|yellowing eyes/skin.||
6280|120|S|   This medication may rarely cause serious (sometimes fatal)||
6280|121|S|problems from blood clots (such as heart attack, stroke, blood||
6280|122|S|clots in the lungs or legs). Get medical help right away if you||
6280|123|S|have: chest/jaw/left arm pain, confusion, sudden||
6280|124|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
6280|125|S|trouble speaking, shortness of breath/rapid breathing,||
6280|126|S|sudden/severe headaches, unusual sweating, weakness on one side||
6280|127|S|of the body, sudden vision changes.||
6280|128|S|   A very serious allergic reaction to this drug is rare.||
6280|129|S|However, get medical help right away if you notice any symptoms||
6280|130|S|of a serious allergic reaction, including: rash, itching/swelling||
6280|131|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6280|132|S|breathing.||
6280|133|S|   This is not a complete list of possible side effects. If you||
6280|134|S|notice other effects not listed above, contact your doctor or||
6280|135|S|pharmacist.||
6280|136|S|   In the US -||
6280|137|S|   Call your doctor for medical advice about side effects. You||
6280|138|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6280|139|S|www.fda.gov/medwatch.||
6280|140|S|   In Canada - Call your doctor for medical advice about side||
6280|141|S|effects. You may report side effects to Health Canada at||
6280|142|S|1-866-234-2345.||
6280|143|B|||
6280|144|P|PRECAUTIONS:  See also Warning section.||
6280|145|P|   Before using this medication, tell your doctor or pharmacist||
6280|146|P|if you are allergic to ethinyl estradiol, norethindrone, or||
6280|147|P|ferrous fumarate; or to other estrogens, progestins, or iron||
6280|148|P|products; or if you have any other allergies. This product may||
6280|149|P|contain inactive ingredients, which can cause allergic reactions||
6280|150|P|or other problems. Talk to your pharmacist for more details.||
6280|151|P|   Before using this medication, tell your doctor or pharmacist||
6280|152|P|your medical history, especially of: blood clots (for example, in||
6280|153|P|the legs, eyes, lungs), blood clotting disorders (such as protein||
6280|154|P|C or protein S deficiency), high blood pressure, abnormal breast||
6280|155|P|exam, cancer (especially endometrial or breast cancer), high||
6280|156|P|cholesterol or triglyceride (blood fat) levels, depression,||
6280|157|P|diabetes, family or personal history of a certain swelling||
6280|158|P|disorder (angioedema), gallbladder problems, severe||
6280|159|P|headaches/migraines, heart problems (such as heart valve disease,||
6280|160|P|irregular heartbeat, previous heart attack), history of yellowing||
6280|161|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
6280|162|P|birth control (such as pills, patch), kidney disease, liver||
6280|163|P|disease (including tumors), obesity, stroke, swelling (edema),||
6280|164|P|thyroid problems, unexplained vaginal bleeding.||
6280|165|P|   If you have diabetes, this medication may affect your blood||
6280|166|P|sugar. Check your blood sugar regularly as directed and share the||
6280|167|P|results with your doctor. Tell your doctor right away if you have||
6280|168|P|symptoms of high blood sugar such as increased thirst/urination.||
6280|169|P|Your doctor may need to adjust your diabetes medication, exercise||
6280|170|P|program, or diet.||
6280|171|P|   Tell your doctor if you just had or will be having surgery or||
6280|172|P|if you will be confined to a bed or chair for a long time (such||
6280|173|P|as a long plane flight). These conditions increase your risk of||
6280|174|P|getting blood clots, especially if you are using hormonal birth||
6280|175|P|control. You may need to stop this medication for a time or take||
6280|176|P|special precautions.||
6280|177|P|   Before having surgery, tell your doctor or dentist about all||
6280|178|P|the products you use (including prescription drugs,||
6280|179|P|nonprescription drugs, and herbal products).||
6280|180|P|   This medication may cause blotchy, dark areas on your face and||
6280|181|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
6280|182|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
6280|183|P|wear protective clothing when outdoors.||
6280|184|P|   If you are nearsighted or wear contact lenses, you may develop||
6280|185|P|vision problems or trouble wearing your contact lenses. Contact||
6280|186|P|your eye doctor if these problems occur.||
6280|187|P|   It may take longer for you to become pregnant after you stop||
6280|188|P|taking birth control pills. Consult your doctor.||
6280|189|P|   This medication should not be used during pregnancy. If you||
6280|190|P|become pregnant or think you may be pregnant, tell your doctor||
6280|191|P|right away. If you have just given birth or had a pregnancy||
6280|192|P|loss/abortion after the first 3 months, talk with your doctor||
6280|193|P|about reliable forms of birth control, and find out when it is||
6280|194|P|safe to start using birth control that contains a form of||
6280|195|P|estrogen, such as this medication.||
6280|196|P|   A small amount of this medication passes into breast milk and||
6280|197|P|may have undesirable effects on a nursing infant. Consult your||
6280|198|P|doctor before breastfeeding.||
6280|199|B|||
6280|200|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6280|201|I|medications work or increase your risk for serious side effects.||
6280|202|I|This document does not contain all possible drug interactions.||
6280|203|I|Keep a list of all the products you use (including||
6280|204|I|prescription/nonprescription drugs and herbal products) and share||
6280|205|I|it with your doctor and pharmacist. Do not start, stop, or change||
6280|206|I|the dosage of any medicines without your doctor's approval.||
6280|207|I|   Some products that may interact with this drug include:||
6280|208|I|aromatase inhibitors (such as anastrozole, exemestane),||
6280|209|I|fezolinetant, ospemifene, tamoxifen, tizanidine, tranexamic acid.||
6280|210|I|   Some drugs may cause hormonal birth control to work less well||
6280|211|I|by decreasing the amount of birth control hormones in your body.||
6280|212|I|This effect can result in pregnancy. Examples include||
6280|213|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
6280|214|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
6280|215|I|seizures (such as barbiturates, carbamazepine, felbamate,||
6280|216|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
6280|217|I|nevirapine), among others.||
6280|218|I|   Tell your doctor when you start any new drug, and discuss if||
6280|219|I|you should use reliable backup birth control. Also tell your||
6280|220|I|doctor if you have any new spotting or breakthrough bleeding,||
6280|221|I|because these may be signs that your birth control is not working||
6280|222|I|well.||
6280|223|I|   The iron in the inactive pill can decrease the absorption of||
6280|224|I|certain drugs, especially if you take them around the same time.||
6280|225|I|These drugs include bisphosphonates (such as alendronate),||
6280|226|I|levodopa, penicillamine, quinolone antibiotics (such as||
6280|227|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
6280|228|I|doxycycline, minocycline), thyroid medications (such as||
6280|229|I|levothyroxine), among others. Ask your doctor or pharmacist if||
6280|230|I|you should throw away the inactive pills (iron tablets) each day||
6280|231|I|rather than taking them.||
6280|232|I|   This medication may interfere with certain lab tests (such as||
6280|233|I|blood clotting factors, thyroid), possibly causing false test||
6280|234|I|results. Make sure lab personnel and all your doctors know you||
6280|235|I|use this drug.||
6280|236|B|||
6280|237|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6280|238|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6280|239|O|poison control center right away. US residents can call||
6280|240|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6280|241|O|Symptoms of overdose may include severe nausea and vomiting,||
6280|242|O|sudden/unusual vaginal bleeding.||
6280|243|B|||
6280|244|N|NOTES:  Do not share this medication with others.||
6280|245|N|   Regular complete physical exams which include lab and/or||
6280|246|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
6280|247|N|Pap smear) should be done while you are taking this medication.||
6280|248|N|Follow your doctor's instructions for examining your breasts, and||
6280|249|N|report any lumps right away. Keep all medical and lab||
6280|250|N|appointments. Consult your doctor for more details.||
6280|251|B|||
6280|252|D|MISSED DOSE:  Refer to the product package information for advice||
6280|253|D|on missed doses. You may need to use backup birth control (such||
6280|254|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
6280|255|D|pharmacist if you have any questions.||
6280|256|D|   If you often forget to take your pills as directed, contact||
6280|257|D|your doctor to discuss switching to another form of birth||
6280|258|D|control.||
6280|259|B|||
6280|260|R|STORAGE:  Store at room temperature away from light and moisture.||
6280|261|R|Do not store in the bathroom. Keep all medications away from||
6280|262|R|children and pets.||
6280|263|R|   Do not flush medications down the toilet or pour them into a||
6280|264|R|drain unless instructed to do so. Properly discard this product||
6280|265|R|when it is expired or no longer needed. Consult your pharmacist||
6280|266|R|or local waste disposal company.||
6280|267|B|||
6280|268|A|Information last revised October 2025.||
6280|269|A|Copyright(c) 2025 First Databank, Inc.||
6280|270|B|||
6284|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6284|002|Z|does NOT have all possible information about this product. This||
6284|003|Z|information does not assure that this product is safe, effective,||
6284|004|Z|or appropriate for you. This information is not individual||
6284|005|Z|medical advice and does not substitute for the advice of your||
6284|006|Z|health care professional. Always ask your health care||
6284|007|Z|professional for complete information about this product and your||
6284|008|Z|specific health needs.||
6284|009|B|||
6284|010|T|LOVASTATIN EXTENDED-RELEASE - ORAL||
6284|011|F|(LOE-va-STAT-in)||
6284|012|B|||
6284|013|C|COMMON BRAND NAME(S): Altoprev||
6284|014|B|||
6284|015|U|USES:  Lovastatin is used along with a proper diet to help lower||
6284|016|U|"bad" cholesterol and fats (such as LDL, triglycerides) and raise||
6284|017|U|"good" cholesterol (HDL) in the blood. It belongs to a group of||
6284|018|U|drugs known as "statins." It works by reducing the amount of||
6284|019|U|cholesterol made by the liver. Lowering "bad" cholesterol and||
6284|020|U|triglycerides and raising "good" cholesterol decreases the risk||
6284|021|U|of heart disease and helps prevent strokes and heart attacks.||
6284|022|U|   In addition to eating a proper diet (such as a||
6284|023|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
6284|024|U|help this medication work better include exercising, losing||
6284|025|U|weight if overweight, and stopping smoking. Consult your doctor||
6284|026|U|for more details.||
6284|027|B|||
6284|028|H|HOW TO USE:  Take this medication by mouth with or without food||
6284|029|H|as directed by your doctor, usually once daily at bedtime.||
6284|030|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
6284|031|H|Doing so can release all of the drug at once, increasing the risk||
6284|032|H|of side effects.||
6284|033|H|   Dosage is based on your medical condition, response to||
6284|034|H|treatment, age, and other medications you may be taking. Be sure||
6284|035|H|to tell your doctor and pharmacist about all the products you use||
6284|036|H|(including prescription drugs, nonprescription drugs, and herbal||
6284|037|H|products).||
6284|038|H|   Avoid eating grapefruit or drinking grapefruit juice while||
6284|039|H|using this medication unless your doctor or pharmacist says you||
6284|040|H|may do so safely. Grapefruit can increase the chance of side||
6284|041|H|effects with this medicine. Ask your doctor or pharmacist for||
6284|042|H|more details.||
6284|043|H|   If you also take certain other drugs to lower your cholesterol||
6284|044|H|(bile acid-binding resins such as cholestyramine or colestipol),||
6284|045|H|take lovastatin at least 1 hour before or at least 4 hours after||
6284|046|H|taking these medications. These products can react with||
6284|047|H|lovastatin, preventing its full absorption.||
6284|048|H|   Take this medication regularly in order to get the most||
6284|049|H|benefit from it. Remember to take it at the same time each day.||
6284|050|H|Keep taking this medication even if you feel well. Most people||
6284|051|H|with high cholesterol or triglycerides do not feel sick.||
6284|052|H|   It is very important to continue to follow your doctor's||
6284|053|H|advice about diet and exercise. It may take up to 4 weeks before||
6284|054|H|you get the full benefit of this drug.||
6284|055|B|||
6284|056|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
6284|057|S|because your doctor has judged that the benefit to you is greater||
6284|058|S|than the risk of side effects. Many people using this medication||
6284|059|S|do not have serious side effects.||
6284|060|S|   A very small number of people taking lovastatin may have mild||
6284|061|S|memory problems or confusion. If these rare effects occur, talk||
6284|062|S|to your doctor.||
6284|063|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
6284|064|S|doctor about the benefits and risks.||
6284|065|S|   This drug may rarely cause muscle problems (which can rarely||
6284|066|S|lead to very serious conditions called rhabdomyolysis and||
6284|067|S|autoimmune myopathy). Tell your doctor right away if you develop||
6284|068|S|any of these symptoms during treatment and if these symptoms last||
6284|069|S|after your doctor stops this drug: muscle||
6284|070|S|pain/tenderness/weakness (especially with fever or unusual||
6284|071|S|tiredness), signs of kidney problems (such as change in the||
6284|072|S|amount of urine).||
6284|073|S|   This medication may rarely cause liver problems. Tell your||
6284|074|S|doctor right away if you develop symptoms of liver problems,||
6284|075|S|including: nausea/vomiting that doesn't stop, yellowing||
6284|076|S|eyes/skin, dark urine, stomach/abdominal pain.||
6284|077|S|   A very serious allergic reaction to this drug is rare.||
6284|078|S|However, get medical help right away if you notice any symptoms||
6284|079|S|of a serious allergic reaction, including: rash, itching/swelling||
6284|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6284|081|S|breathing.||
6284|082|S|   This is not a complete list of possible side effects. If you||
6284|083|S|notice other effects not listed above, contact your doctor or||
6284|084|S|pharmacist.||
6284|085|S|   In the US -||
6284|086|S|   Call your doctor for medical advice about side effects. You||
6284|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6284|088|S|www.fda.gov/medwatch.||
6284|089|S|   In Canada - Call your doctor for medical advice about side||
6284|090|S|effects. You may report side effects to Health Canada at||
6284|091|S|1-866-234-2345.||
6284|092|B|||
6284|093|P|PRECAUTIONS:  Before taking lovastatin, tell your doctor or||
6284|094|P|pharmacist if you are allergic to it; or if you have any other||
6284|095|P|allergies. This product may contain inactive ingredients, which||
6284|096|P|can cause allergic reactions or other problems. Talk to your||
6284|097|P|pharmacist for more details.||
6284|098|P|   Before using this medication, tell your doctor or pharmacist||
6284|099|P|your medical history, especially of: liver disease, kidney||
6284|100|P|disease, alcohol use.||
6284|101|P|   Before having surgery, tell your doctor or dentist about all||
6284|102|P|the products you use (including prescription drugs,||
6284|103|P|nonprescription drugs, and herbal products).||
6284|104|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
6284|105|P|your risk for liver problems, especially when combined with||
6284|106|P|lovastatin. Ask your doctor or pharmacist for more information.||
6284|107|P|   Older adults may be more sensitive to the side effects of this||
6284|108|P|drug, especially muscle problems.||
6284|109|P|   During pregnancy, this medication should be used only when||
6284|110|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
6284|111|P|benefits with your doctor.||
6284|112|P|   It is unknown if this medication passes into breast milk.||
6284|113|P|Because of the possible risk to the infant, breastfeeding is not||
6284|114|P|recommended while using this medication. Consult your doctor||
6284|115|P|before breastfeeding.||
6284|116|B|||
6284|117|I|DRUG INTERACTIONS:  See also How to Use section.||
6284|118|I|   Drug interactions may change how your medications work or||
6284|119|I|increase your risk for serious side effects. This document does||
6284|120|I|not contain all possible drug interactions. Keep a list of all||
6284|121|I|the products you use (including prescription/nonprescription||
6284|122|I|drugs and herbal products) and share it with your doctor and||
6284|123|I|pharmacist. Do not start, stop, or change the dosage of any||
6284|124|I|medicines without your doctor's approval.||
6284|125|I|   Some products that may interact with this drug include: "blood||
6284|126|I|thinners" (such as warfarin), daptomycin, gemfibrozil.||
6284|127|I|   Other medications can affect the removal of lovastatin from||
6284|128|I|your body, which may affect how lovastatin works. Examples||
6284|129|I|include certain azole antifungals (such as itraconazole,||
6284|130|I|ketoconazole, posaconazole, voriconazole), cobicistat,||
6284|131|I|colchicine, cyclosporine, macrolide antibiotics (such as||
6284|132|I|clarithromycin, erythromycin), nefazodone, HIV protease||
6284|133|I|inhibitors (such as lopinavir), ritonavir, telithromycin, among||
6284|134|I|others.||
6284|135|I|   Do not take any red yeast rice products while you are taking||
6284|136|I|lovastatin since those products may also contain lovastatin.||
6284|137|I|Taking lovastatin and red yeast rice products together can||
6284|138|I|increase your risk of serious muscle and liver problems.||
6284|139|B|||
6284|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6284|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6284|142|O|poison control center right away. US residents can call||
6284|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6284|144|B|||
6284|145|N|NOTES:  Do not share this medication with others.||
6284|146|N|   Lab and/or medical tests (such as blood||
6284|147|N|cholesterol/triglyceride levels, liver function) should be done||
6284|148|N|while you are taking this medication. Keep all medical and lab||
6284|149|N|appointments. Consult your doctor for more details.||
6284|150|B|||
6284|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6284|152|D|remember. If it is near the time of the next dose, skip the||
6284|153|D|missed dose. Take your next dose at the regular time. Do not||
6284|154|D|double the dose to catch up.||
6284|155|B|||
6284|156|R|STORAGE:  Store at room temperature away from light and moisture.||
6284|157|R|Do not store in the bathroom. Keep all medications away from||
6284|158|R|children and pets.||
6284|159|R|   Do not flush medications down the toilet or pour them into a||
6284|160|R|drain unless instructed to do so. Properly discard this product||
6284|161|R|when it is expired or no longer needed. Consult your pharmacist||
6284|162|R|or local waste disposal company.||
6284|163|B|||
6284|164|A|Information last revised May 2024.||
6284|165|A|Copyright(c) 2025 First Databank, Inc.||
6284|166|B|||
6289|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6289|002|Z|does NOT have all possible information about this product. This||
6289|003|Z|information does not assure that this product is safe, effective,||
6289|004|Z|or appropriate for you. This information is not individual||
6289|005|Z|medical advice and does not substitute for the advice of your||
6289|006|Z|health care professional. Always ask your health care||
6289|007|Z|professional for complete information about this product and your||
6289|008|Z|specific health needs.||
6289|009|B|||
6289|010|T|KETOTIFEN - OPHTHALMIC||
6289|011|F|(KEE-toe-TYE-fen)||
6289|012|B|||
6289|013|C|COMMON BRAND NAME(S): Zaditor||
6289|014|B|||
6289|015|U|USES:  This medication is used to prevent and treat itching of||
6289|016|U|the eyes caused by allergies (allergic/seasonal conjunctivitis).||
6289|017|U|Ketotifen is an antihistamine for the eye that treats allergic||
6289|018|U|symptoms by blocking a certain natural substance (histamine). It||
6289|019|U|is also a mast cell stabilizer that prevents allergic reactions||
6289|020|U|by reducing the release of natural substances that cause an||
6289|021|U|allergic reaction.||
6289|022|B|||
6289|023|H|HOW TO USE:  If you are using the over-the-counter product, read||
6289|024|H|all directions on the product package before using this||
6289|025|H|medication. If your doctor has prescribed this medication, use it||
6289|026|H|exactly as directed.||
6289|027|H|   Use this medication in the affected eye(s) as directed by the||
6289|028|H|product package or by your doctor, usually twice a day (every 8||
6289|029|H|to 12 hours).||
6289|030|H|   Dosage is based on your medical condition and response to||
6289|031|H|treatment.||
6289|032|H|   To apply eye drops, wash your hands first. To avoid||
6289|033|H|contamination, do not touch the dropper tip or let it touch your||
6289|034|H|eye or any other surface.||
6289|035|H|   Ask your doctor if you can wear contact lenses while you are||
6289|036|H|being treated with this medication. If your doctor says you may||
6289|037|H|continue wearing them, remove them before using the eye drops,||
6289|038|H|and wait at least 10 minutes after each dose before putting in||
6289|039|H|your lenses. Do not use this medication to treat irritation from||
6289|040|H|contact lens wear. Consult your doctor about the use of contact||
6289|041|H|lenses when the eyes are red or irritated.||
6289|042|H|   Tilt your head back, look upward, and pull down the lower||
6289|043|H|eyelid to make a pouch. Hold the dropper directly over your eye||
6289|044|H|and apply 1 drop in the lower eyelid. Look downward and gently||
6289|045|H|close your eyes for 1 to 2 minutes. Place one finger at the||
6289|046|H|corner of your eye (near the nose) and apply gentle pressure.||
6289|047|H|This will prevent the medication from draining out. Try not to||
6289|048|H|blink and do not rub your eye.||
6289|049|H|   Do not rinse the dropper. Replace the dropper cap after each||
6289|050|H|use, and keep the bottle tightly closed.||
6289|051|H|   If you are using another kind of eye medication (drops or||
6289|052|H|ointment), wait at least 5 minutes before applying it. Apply eye||
6289|053|H|drops before eye ointments to allow the eye drops to enter the||
6289|054|H|eye.||
6289|055|H|   Wait several minutes for your vision to clear before driving||
6289|056|H|or operating machinery.||
6289|057|H|   If your doctor has prescribed this medication, use it||
6289|058|H|regularly in order to get the most benefit from it. To help you||
6289|059|H|remember, use it at the same times each day. Continue to use this||
6289|060|H|medication as prescribed until pollen season is over or you are||
6289|061|H|no longer exposed to the allergic substance, even when allergic||
6289|062|H|symptoms disappear or improve.||
6289|063|H|   If your condition lasts or gets worse, if you develop new||
6289|064|H|symptoms, or if you think you have a serious medical problem, get||
6289|065|H|medical help right away. If you are treating yourself with||
6289|066|H|nonprescription ketotifen, tell your doctor if your itching gets||
6289|067|H|worse or lasts more than 72 hours. You may need a different||
6289|068|H|medication.||
6289|069|B|||
6289|070|S|SIDE EFFECTS:  Burning/stinging/irritation of the eye, headache,||
6289|071|S|stuffy/runny nose, bad taste in your mouth, and increased||
6289|072|S|sensitivity to light may occur. If any of these effects last or||
6289|073|S|get worse, tell your doctor or pharmacist promptly.||
6289|074|S|   If your doctor has directed you to use this medication,||
6289|075|S|remember that your doctor has judged that the benefit to you is||
6289|076|S|greater than the risk of side effects. Many people using this||
6289|077|S|medication do not have serious side effects.||
6289|078|S|   Tell your doctor right away if you have any serious side||
6289|079|S|effects, including: dry eyes, eye pain, increased||
6289|080|S|redness/swelling of the eye, vision problems.||
6289|081|S|   A very serious allergic reaction to this drug is rare.||
6289|082|S|However, get medical help right away if you notice any symptoms||
6289|083|S|of a serious allergic reaction, including: rash, itching/swelling||
6289|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6289|085|S|breathing.||
6289|086|S|   This is not a complete list of possible side effects. If you||
6289|087|S|notice other effects not listed above, contact your doctor or||
6289|088|S|pharmacist.||
6289|089|S|   In the US -||
6289|090|S|   Call your doctor for medical advice about side effects. You||
6289|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6289|092|S|www.fda.gov/medwatch.||
6289|093|S|   In Canada - Call your doctor for medical advice about side||
6289|094|S|effects. You may report side effects to Health Canada at||
6289|095|S|1-866-234-2345.||
6289|096|B|||
6289|097|P|PRECAUTIONS:  Before using ketotifen, tell your doctor or||
6289|098|P|pharmacist if you are allergic to it; or if you have any other||
6289|099|P|allergies. This product may contain inactive ingredients (such as||
6289|100|P|the preservative benzalkonium chloride in the multi-dose||
6289|101|P|container), which can cause allergic reactions or other problems.||
6289|102|P|Talk to your pharmacist for more details.||
6289|103|P|   Before using this medication, tell your doctor or pharmacist||
6289|104|P|your medical history, especially of: eye problems (such as||
6289|105|P|glaucoma).||
6289|106|P|   After you apply this drug, your vision may become temporarily||
6289|107|P|blurred. Do not drive, use machinery, or do anything that needs||
6289|108|P|clear vision until you can do it safely.||
6289|109|P|   Do not use this medication in children younger than 3 years||
6289|110|P|unless directed by the doctor.||
6289|111|P|   During pregnancy, this medication should be used only when||
6289|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
6289|113|P|   It is unknown if this drug passes into breast milk. Consult||
6289|114|P|your doctor before breastfeeding.||
6289|115|B|||
6289|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6289|117|I|medications work or increase your risk for serious side effects.||
6289|118|I|This document does not contain all possible drug interactions.||
6289|119|I|Keep a list of all the products you use (including||
6289|120|I|prescription/nonprescription drugs and herbal products) and share||
6289|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
6289|122|I|the dosage of any medicines without your doctor's approval.||
6289|123|B|||
6289|124|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6289|125|O|has overdosed and has serious symptoms such as passing out or||
6289|126|O|trouble breathing, call 911. Otherwise, call a poison control||
6289|127|O|center right away. US residents can call 1-800-222-1222. Canada||
6289|128|O|residents can call 1-844-764-7669.||
6289|129|B|||
6289|130|N|NOTES:  Do not share this medication with others.||
6289|131|N|   Avoid allergens (such as pollen, animal dander) and other||
6289|132|N|triggering factors (such as irritants). Cold compresses and||
6289|133|N|lubricating eye drops may decrease eye irritation.||
6289|134|B|||
6289|135|D|MISSED DOSE:  If you are using this medication on a regular||
6289|136|D|schedule and miss a dose, use it as soon as you remember. If it||
6289|137|D|is near the time of the next dose, skip the missed dose. Use your||
6289|138|D|next dose at the regular time. Do not double the dose to catch||
6289|139|D|up.||
6289|140|B|||
6289|141|R|STORAGE:  Different brands of this medication have different||
6289|142|R|storage needs. Check the product package for instructions on how||
6289|143|R|to store your brand, or ask your pharmacist. Keep all medications||
6289|144|R|away from children and pets.||
6289|145|R|   Do not flush medications down the toilet or pour them into a||
6289|146|R|drain unless instructed to do so. Properly discard this product||
6289|147|R|when it is expired or no longer needed. Consult your pharmacist||
6289|148|R|or local waste disposal company.||
6289|149|B|||
6289|150|A|Information last revised November 2024.||
6289|151|A|Copyright(c) 2025 First Databank, Inc.||
6289|152|B|||
6295|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6295|002|Z|does NOT have all possible information about this product. This||
6295|003|Z|information does not assure that this product is safe, effective,||
6295|004|Z|or appropriate for you. This information is not individual||
6295|005|Z|medical advice and does not substitute for the advice of your||
6295|006|Z|health care professional. Always ask your health care||
6295|007|Z|professional for complete information about this product and your||
6295|008|Z|specific health needs.||
6295|009|B|||
6295|010|T|AMOXICILLIN/CLAVULANIC ACID EXTENDED-RELEASE - ORAL||
6295|011|F|(a-MOX-i-SIL-in/KLAV-ue-LAN-ik AS-id)||
6295|012|B|||
6295|013|C|COMMON BRAND NAME(S): Augmentin XR||
6295|014|B|||
6295|015|U|USES:  Amoxicillin/clavulanic acid is a combination||
6295|016|U|penicillin-type antibiotic used to treat a wide variety of||
6295|017|U|bacterial infections. It works by stopping the growth of||
6295|018|U|bacteria.||
6295|019|U|   This antibiotic treats only bacterial infections. It will not||
6295|020|U|work for viral infections (such as common cold, flu). Using any||
6295|021|U|antibiotic when it is not needed can cause it to not work for||
6295|022|U|future infections.||
6295|023|B|||
6295|024|H|HOW TO USE:  Take this medication by mouth with a meal or snack||
6295|025|H|as directed by your doctor, usually every 12 hours. Do not take||
6295|026|H|this medication with a high-fat meal because it can decrease the||
6295|027|H|absorption of the drug. Do not crush or chew extended-release||
6295|028|H|tablets. Doing so can release all of the drug at once, increasing||
6295|029|H|the risk of side effects. Also, do not split the tablets unless||
6295|030|H|they have a score line and your doctor or pharmacist tells you to||
6295|031|H|do so. Swallow the whole or split tablet without crushing or||
6295|032|H|chewing.||
6295|033|H|   For the best effect, take this antibiotic at evenly spaced||
6295|034|H|times. To help you remember, take this medication at the same||
6295|035|H|time(s) every day.||
6295|036|H|   Continue to take this medication until the full prescribed||
6295|037|H|amount is finished, even if symptoms disappear after a few days.||
6295|038|H|Stopping the medication too early may result in a return of the||
6295|039|H|infection.||
6295|040|H|   Tell the doctor if your condition lasts or gets worse.||
6295|041|B|||
6295|042|S|SIDE EFFECTS:  Diarrhea, nausea, or vomiting may occur. If any of||
6295|043|S|these effects last or get worse, tell the doctor or pharmacist||
6295|044|S|promptly. Taking this medication with food will help to reduce||
6295|045|S|stomach upset.||
6295|046|S|   Remember that this medication has been prescribed because your||
6295|047|S|doctor has judged that the benefit to you is greater than the||
6295|048|S|risk of side effects. Many people using this medication do not||
6295|049|S|have serious side effects.||
6295|050|S|   Tell your doctor right away if you have any serious side||
6295|051|S|effects, including: signs of liver disease (such as||
6295|052|S|nausea/vomiting that doesn't stop, loss of appetite,||
6295|053|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
6295|054|S|bruising/bleeding, unusual tiredness.||
6295|055|S|   This medication may rarely cause a severe intestinal condition||
6295|056|S|due to a bacteria called C. difficile. This condition may occur||
6295|057|S|during treatment or weeks to months after treatment has stopped.||
6295|058|S|Tell your doctor right away if you develop: diarrhea that doesn't||
6295|059|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
6295|060|S|stool.||
6295|061|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
6295|062|S|products because they may make symptoms worse||
6295|063|S|   Use of this medication for prolonged or repeated periods may||
6295|064|S|result in oral thrush or a new yeast infection. Contact the||
6295|065|S|doctor if you notice white patches in your mouth, a change in||
6295|066|S|vaginal discharge or other new symptoms.||
6295|067|S|   A very serious allergic reaction to this drug is rare.||
6295|068|S|However, get medical help right away if you notice any symptoms||
6295|069|S|of a serious allergic reaction, including: fever that doesn't go||
6295|070|S|away, new or worsening lymph node swelling, rash,||
6295|071|S|itching/swelling (especially of the face/tongue/throat), severe||
6295|072|S|dizziness, trouble breathing.||
6295|073|S|   Amoxicillin can commonly cause a mild rash that is usually not||
6295|074|S|serious. However, you may not be able to tell it apart from a||
6295|075|S|rare rash that could be a sign of a severe allergic reaction. Get||
6295|076|S|medical help right away if you develop any rash.||
6295|077|S|   This is not a complete list of possible side effects. If you||
6295|078|S|notice other effects not listed above, contact your doctor or||
6295|079|S|pharmacist.||
6295|080|S|   In the US -||
6295|081|S|   Call your doctor for medical advice about side effects. You||
6295|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6295|083|S|www.fda.gov/medwatch.||
6295|084|S|   In Canada - Call your doctor for medical advice about side||
6295|085|S|effects. You may report side effects to Health Canada at||
6295|086|S|1-866-234-2345.||
6295|087|B|||
6295|088|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
6295|089|P|pharmacist if you are allergic to amoxicillin or clavulanic acid;||
6295|090|P|or to penicillin or cephalosporin antibiotics; or if you have any||
6295|091|P|other allergies. This product may contain inactive ingredients,||
6295|092|P|which can cause allergic reactions or other problems. Talk to||
6295|093|P|your pharmacist for more details.||
6295|094|P|   Before using this medication, tell the doctor or pharmacist||
6295|095|P|your medical history, especially of: liver disease (including||
6295|096|P|liver problems caused by previous use of amoxicillin/clavulanic||
6295|097|P|acid), kidney disease (such as requiring dialysis), a certain||
6295|098|P|type of viral infection (infectious mononucleosis).||
6295|099|P|   Before having surgery, tell your doctor or dentist about all||
6295|100|P|the products you use (including prescription drugs,||
6295|101|P|nonprescription drugs, and herbal products).||
6295|102|P|   This product may cause live bacterial vaccines (such as||
6295|103|P|typhoid vaccine) to not work well. Tell your health care||
6295|104|P|professional that you are using this medication before having any||
6295|105|P|immunizations/vaccinations.||
6295|106|P|   During pregnancy, this medication should be used only when||
6295|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
6295|108|P|   This medication passes into breast milk. Consult your doctor||
6295|109|P|before breastfeeding.||
6295|110|B|||
6295|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6295|112|I|medications work or increase your risk for serious side effects.||
6295|113|I|This document does not contain all possible drug interactions.||
6295|114|I|Keep a list of all the products you use (including||
6295|115|I|prescription/nonprescription drugs and herbal products) and share||
6295|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
6295|117|I|the dosage of any medicines without your doctor's approval.||
6295|118|I|   A product that may interact with this drug is: methotrexate.||
6295|119|I|   This medication may interfere with certain lab tests (such as||
6295|120|I|certain urine glucose tests), possibly causing false test||
6295|121|I|results. Make sure lab personnel and all your doctors know you||
6295|122|I|use this drug.||
6295|123|B|||
6295|124|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6295|125|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6295|126|O|poison control center right away. US residents can call||
6295|127|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6295|128|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
6295|129|O|severe vomiting, change in the amount of urine.||
6295|130|B|||
6295|131|N|NOTES:  Do not share this medication with others.||
6295|132|N|   This medication has been prescribed for your current condition||
6295|133|N|only. Do not use it later for another infection unless your||
6295|134|N|doctor tells you to.||
6295|135|N|   With long-term treatment, lab and/or medical tests (such as||
6295|136|N|kidney/liver function, complete blood counts) may be done while||
6295|137|N|you are taking this medication. Keep all medical and lab||
6295|138|N|appointments. Consult your doctor for more details.||
6295|139|B|||
6295|140|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6295|141|D|remember. If it is near the time of the next dose, skip the||
6295|142|D|missed dose. Take your next dose at the regular time. Do not||
6295|143|D|double the dose to catch up.||
6295|144|B|||
6295|145|R|STORAGE:  Store at room temperature away from light and moisture.||
6295|146|R|Do not store in the bathroom. Keep all medications away from||
6295|147|R|children and pets.||
6295|148|R|   Do not flush medications down the toilet or pour them into a||
6295|149|R|drain unless instructed to do so. Properly discard this product||
6295|150|R|when it is expired or no longer needed. Consult your pharmacist||
6295|151|R|or local waste disposal company.||
6295|152|B|||
6295|153|A|Information last revised May 2024.||
6295|154|A|Copyright(c) 2025 First Databank, Inc.||
6295|155|B|||
6298|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6298|002|Z|does NOT have all possible information about this product. This||
6298|003|Z|information does not assure that this product is safe, effective,||
6298|004|Z|or appropriate for you. This information is not individual||
6298|005|Z|medical advice and does not substitute for the advice of your||
6298|006|Z|health care professional. Always ask your health care||
6298|007|Z|professional for complete information about this product and your||
6298|008|Z|specific health needs.||
6298|009|B|||
6298|010|T|FENTANYL LOZENGE - BUCCAL||
6298|011|F|(FEN-ta-nil)||
6298|012|B|||
6298|013|C|COMMON BRAND NAME(S): Actiq||
6298|014|B|||
6298|015|W|WARNING:  See also Uses section.||
6298|016|W|   Fentanyl has a risk for abuse and addiction, which can lead to||
6298|017|W|overdose and death. Fentanyl may also cause severe, possibly||
6298|018|W|fatal, breathing problems. Do not use fentanyl lozenges unless||
6298|019|W|you have been regularly taking moderate to large amounts of||
6298|020|W|opioid pain medication. Otherwise, it may cause overdose (even||
6298|021|W|death). To lower your risk, your doctor should have you use the||
6298|022|W|smallest dose of fentanyl that works, and use it for the shortest||
6298|023|W|possible time. See also How to Use section for more information||
6298|024|W|about addiction.||
6298|025|W|   Ask your doctor or pharmacist if you should have medication||
6298|026|W|available to treat opioid overdose (such as naloxone, nalmefene).||
6298|027|W|Teach your family or household members about the signs of an||
6298|028|W|opioid overdose and how to treat it.||
6298|029|W|   The risk for severe breathing problems is higher when you||
6298|030|W|start this medication and after a dose increase, or if you use||
6298|031|W|the wrong dose/strength. Using this medication with alcohol or||
6298|032|W|other drugs that can cause drowsiness or breathing problems may||
6298|033|W|cause very serious side effects, including death. Be sure you||
6298|034|W|know how to use fentanyl and what other drugs you should avoid||
6298|035|W|using with it. See also Drug Interactions section. Get medical||
6298|036|W|help right away if any of these very serious side effects occur:||
6298|037|W|slow/shallow breathing, unusual lightheadedness, severe||
6298|038|W|drowsiness/dizziness, difficulty waking up.||
6298|039|W|   Carefully follow the specific directions for using fentanyl||
6298|040|W|lozenges. Since they are not taken the same way, different forms||
6298|041|W|of fentanyl (including lozenges, buccal tablets, patches) do not||
6298|042|W|have the same effects at equal strengths and should not be||
6298|043|W|substituted for each other. Tell your doctor or pharmacist of all||
6298|044|W|medications that you use, especially of drugs that can affect how||
6298|045|W|fentanyl works. Do not start, stop, or change the dosage of any||
6298|046|W|medicines you are using without your doctor's approval.||
6298|047|W|   Keep this medicine in a safe place to prevent theft, misuse,||
6298|048|W|or abuse. Properly throw away all opened units of this drug. If||
6298|049|W|someone accidentally swallows this drug, get medical help right||
6298|050|W|away.||
6298|051|W|   To receive fentanyl in the United States, you must understand,||
6298|052|W|agree to, and carefully follow the requirements of the REMS||
6298|053|W|Program for this medication. If you live in Canada or any other||
6298|054|W|country, consult your doctor and pharmacist for your country's||
6298|055|W|regulations.||
6298|056|W|   Before using this medication, women of childbearing age should||
6298|057|W|talk with their doctor(s) about the risks and benefits. Tell your||
6298|058|W|doctor if you are pregnant or if you plan to become pregnant.||
6298|059|W|During pregnancy, this medication should be used only when||
6298|060|W|clearly needed. It may slightly increase the risk of birth||
6298|061|W|defects if used during the first two months of pregnancy. Also,||
6298|062|W|using it for a long time or in high doses near the expected||
6298|063|W|delivery date may harm the unborn baby. To lessen the risk, use||
6298|064|W|the smallest effective dose for the shortest possible time.||
6298|065|W|Babies born to mothers who use this drug for a long time may||
6298|066|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
6298|067|W|doctor right away if you notice any symptoms in your newborn baby||
6298|068|W|such as crying that doesn't stop, slow/shallow breathing,||
6298|069|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
6298|070|W|difficulty gaining weight.||
6298|071|B|||
6298|072|U|USES:  This medication is used to help relieve sudden||
6298|073|U|(breakthrough) cancer pain in people who are regularly taking||
6298|074|U|moderate to large amounts of opioid pain medication. Fentanyl||
6298|075|U|belongs to a class of drugs known as opioid analgesics. It works||
6298|076|U|in the brain to change how your body feels and responds to pain.||
6298|077|U|   This medication should not be used to relieve mild or||
6298|078|U|short-term pain (such as due to headache/migraine, dental||
6298|079|U|procedures, surgery).||
6298|080|B|||
6298|081|H|HOW TO USE:  Read the Medication Guide provided by your||
6298|082|H|pharmacist before you start using fentanyl and each time you get||
6298|083|H|a refill. Learn all usage and disposal instructions. If you have||
6298|084|H|any questions, ask your doctor or pharmacist.||
6298|085|H|   A Child Safety Kit is available from the manufacturer. It||
6298|086|H|contains important safety and educational materials and a safe||
6298|087|H|storage container to keep this medication out of reach of||
6298|088|H|children. If you have any questions about the materials in this||
6298|089|H|kit, bring them to your doctor or pharmacist, or contact the||
6298|090|H|manufacturer.||
6298|091|H|   Use fentanyl lozenges as directed by your doctor. Just before||
6298|092|H|using, open the package with scissors. Remove the lozenge and||
6298|093|H|place the medication end in your mouth between your cheeks and||
6298|094|H|gums. Actively suck on the medication. Twirl the handle often and||
6298|095|H|move the medication along the cheeks in your mouth, occasionally||
6298|096|H|switching sides of the mouth. You should finish the medication in||
6298|097|H|15 minutes to get the most relief. Do not bite or chew the||
6298|098|H|medication. You may drink some water before using this||
6298|099|H|medication, but do not eat or drink anything while you are using||
6298|100|H|it.||
6298|101|H|   Avoid eating grapefruit or drinking grapefruit juice while||
6298|102|H|using this medication unless your doctor or pharmacist says you||
6298|103|H|may do so safely. Grapefruit can increase the chance of side||
6298|104|H|effects with this medicine. Ask your doctor or pharmacist for||
6298|105|H|more details.||
6298|106|H|   If you start to have side effects (such as dizziness, feeling||
6298|107|H|sick to your stomach, severe drowsiness) before finishing a dose,||
6298|108|H|your doctor may need to adjust your dose. Remove the rest of the||
6298|109|H|lozenge from your mouth and store or dispose of it properly (see||
6298|110|H|Medication Guide). Tell your doctor promptly if this happens.||
6298|111|H|   The dosage is based on your medical condition and response to||
6298|112|H|treatment. If you need a second dose, wait 30 minutes after||
6298|113|H|starting the first dose. Do not use more than 2 doses per episode||
6298|114|H|of breakthrough pain. Wait at least 4 hours before using fentanyl||
6298|115|H|lozenges again for another episode of breakthrough pain. To avoid||
6298|116|H|any confusion and chance of overdose, you should only keep a||
6298|117|H|supply of one strength of this medication. Do not increase your||
6298|118|H|dose, take the medication more often, or take it for a longer||
6298|119|H|time than prescribed.||
6298|120|H|   Pain medications work best if they are used when the first||
6298|121|H|signs of pain occur. If you wait until the pain has worsened, the||
6298|122|H|medication may not work as well.||
6298|123|H|   You should continue to also take your long-acting opioid||
6298|124|H|medication as directed by your doctor. Other pain relievers (such||
6298|125|H|as acetaminophen, ibuprofen) may also be prescribed. Ask your||
6298|126|H|doctor or pharmacist about using fentanyl safely with other||
6298|127|H|drugs.||
6298|128|H|   Suddenly stopping this medication may cause withdrawal,||
6298|129|H|especially if you have used it for a long time or in high doses.||
6298|130|H|To prevent withdrawal, your doctor may lower your dose slowly.||
6298|131|H|Tell your doctor or pharmacist right away if you have any||
6298|132|H|withdrawal symptoms such as restlessness, mental/mood changes||
6298|133|H|(including anxiety, trouble sleeping, thoughts of suicide),||
6298|134|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
6298|135|H|aches, or sudden changes in behavior.||
6298|136|H|   When this medication is used for a long time, it may not work||
6298|137|H|as well. Talk with your doctor if this medication stops working||
6298|138|H|well.||
6298|139|H|   Though it helps many people, this medication may sometimes||
6298|140|H|cause addiction. This risk may be higher if you have a||
6298|141|H|mental/mood disorder or a substance use disorder (such as overuse||
6298|142|H|of or addiction to drugs/alcohol). Use this medication exactly as||
6298|143|H|prescribed to lower the risk of addiction. Ask your doctor or||
6298|144|H|pharmacist for more details.||
6298|145|H|   Tell your doctor if your pain does not get better or if it||
6298|146|H|gets worse, or if you have any new pain. Also tell your doctor if||
6298|147|H|you have more than 4 episodes of breakthrough pain daily, or if||
6298|148|H|you need to use 2 units of medication for each episode of pain.||
6298|149|B|||
6298|150|S|SIDE EFFECTS:  See also Warning section.||
6298|151|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
6298|152|S|drowsiness, or headache may occur. Pain, sores, or irritation in||
6298|153|S|the mouth (where the medication has been applied) may also occur.||
6298|154|S|Some of these side effects may decrease after you have been using||
6298|155|S|this medication for a while. If any of these effects last or get||
6298|156|S|worse, tell your doctor or pharmacist promptly.||
6298|157|S|   To prevent constipation, eat dietary fiber, drink enough||
6298|158|S|water, and exercise. You may also need to take a laxative. Ask||
6298|159|S|your pharmacist which type of laxative is right for you.||
6298|160|S|   To reduce the risk of dizziness and lightheadedness, get up||
6298|161|S|slowly when rising from a sitting or lying position.||
6298|162|S|   Remember that this medication has been prescribed because your||
6298|163|S|doctor has judged that the benefit to you is greater than the||
6298|164|S|risk of side effects. Many people using this medication do not||
6298|165|S|have serious side effects.||
6298|166|S|   Tell your doctor right away if you have any serious side||
6298|167|S|effects, including: interrupted breathing during sleep (sleep||
6298|168|S|apnea), mental/mood changes (such as agitation, confusion,||
6298|169|S|hallucinations), severe stomach/abdominal pain, difficulty||
6298|170|S|urinating, signs of your adrenal glands not working well (such as||
6298|171|S|loss of appetite, unusual tiredness, weight loss), trouble||
6298|172|S|swallowing.||
6298|173|S|   Get medical help right away if you have any very serious side||
6298|174|S|effects, including: fainting, seizure, slow/shallow breathing,||
6298|175|S|severe drowsiness/difficulty waking up.||
6298|176|S|   This medication may increase serotonin and rarely cause a very||
6298|177|S|serious condition called serotonin syndrome/toxicity. The risk||
6298|178|S|increases if you are also taking other drugs that increase||
6298|179|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
6298|180|S|take (see Drug Interactions section). Get medical help right away||
6298|181|S|if you develop some of the following symptoms: fast heartbeat,||
6298|182|S|hallucinations, loss of coordination, severe dizziness, severe||
6298|183|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
6298|184|S|unusual agitation/restlessness.||
6298|185|S|   A very serious allergic reaction to this drug is rare.||
6298|186|S|However, get medical help right away if you notice any symptoms||
6298|187|S|of a serious allergic reaction, including: rash, itching/swelling||
6298|188|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6298|189|S|breathing.||
6298|190|S|   This is not a complete list of possible side effects. If you||
6298|191|S|notice other effects not listed above, contact your doctor or||
6298|192|S|pharmacist.||
6298|193|S|   In the US -||
6298|194|S|   Call your doctor for medical advice about side effects. You||
6298|195|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6298|196|S|www.fda.gov/medwatch.||
6298|197|S|   In Canada - Call your doctor for medical advice about side||
6298|198|S|effects. You may report side effects to Health Canada at||
6298|199|S|1-866-234-2345.||
6298|200|B|||
6298|201|P|PRECAUTIONS:  Before taking fentanyl, tell your doctor or||
6298|202|P|pharmacist if you are allergic to it; or if you have any other||
6298|203|P|allergies. This product may contain inactive ingredients, which||
6298|204|P|can cause allergic reactions or other problems. Talk to your||
6298|205|P|pharmacist for more details.||
6298|206|P|   Before using this medication, tell your doctor or pharmacist||
6298|207|P|your medical history, especially of: brain disorders (such as||
6298|208|P|head injury, tumor, seizures), breathing problems (such as||
6298|209|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
6298|210|P|diabetes, kidney disease, liver disease, mental/mood disorders||
6298|211|P|(such as confusion, depression), personal or family history of a||
6298|212|P|substance use disorder (such as overuse of or addiction to||
6298|213|P|drugs/alcohol), stomach/intestinal problems (such as blockage,||
6298|214|P|constipation, diarrhea due to infection, paralytic ileus),||
6298|215|P|difficulty urinating (such as due to enlarged prostate),||
6298|216|P|gallbladder disease, disease of the pancreas (pancreatitis).||
6298|217|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6298|218|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6298|219|P|machinery, or do anything that needs alertness until you can do||
6298|220|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6298|221|P|are using marijuana (cannabis).||
6298|222|P|   Before having surgery, tell your doctor or dentist about all||
6298|223|P|the products you use (including prescription drugs,||
6298|224|P|nonprescription drugs, and herbal products).||
6298|225|P|   This medication contains sugar and may increase your chance of||
6298|226|P|developing cavities or gum problems. Tell your dentist that you||
6298|227|P|are using this medication. Brush and floss your teeth daily and||
6298|228|P|have regular dental exams.||
6298|229|P|   There is sugar in this medication. If you have diabetes, check||
6298|230|P|your blood sugar regularly as directed and share the results with||
6298|231|P|your doctor.||
6298|232|P|   Older adults may be more sensitive to the side effects of this||
6298|233|P|drug, especially confusion, dizziness, drowsiness, and||
6298|234|P|slow/shallow breathing.||
6298|235|P|   During pregnancy, this medication should be used only when||
6298|236|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
6298|237|P|benefits with your doctor. (See also Warning section.)||
6298|238|P|   This drug passes into breast milk and may have undesirable||
6298|239|P|effects on a nursing infant. Tell the doctor right away if your||
6298|240|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
6298|241|P|breathing. Consult your doctor before breastfeeding.||
6298|242|B|||
6298|243|I|DRUG INTERACTIONS:  See also Warning section.||
6298|244|I|   Drug interactions may change how your medications work or||
6298|245|I|increase your risk for serious side effects. This document does||
6298|246|I|not contain all possible drug interactions. Keep a list of all||
6298|247|I|the products you use (including prescription/nonprescription||
6298|248|I|drugs and herbal products) and share it with your doctor and||
6298|249|I|pharmacist. Do not start, stop, or change the dosage of any||
6298|250|I|medicines without your doctor's approval.||
6298|251|I|   Some products that may interact with this drug include:||
6298|252|I|certain pain medications (mixed opioid agonist-antagonists such||
6298|253|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
6298|254|I|samidorphan.||
6298|255|I|   Other medications can affect the removal of fentanyl from your||
6298|256|I|body, which may affect how fentanyl works. Examples include azole||
6298|257|I|antifungals (such as itraconazole, ketoconazole), calcium channel||
6298|258|I|blockers (such as diltiazem, verapamil), HIV protease inhibitors||
6298|259|I|(such as nelfinavir), macrolide antibiotics (such as||
6298|260|I|erythromycin), mifepristone, nefazodone, rifamycins (such as||
6298|261|I|rifabutin), ritonavir, certain drugs used to treat seizures (such||
6298|262|I|as carbamazepine, phenytoin), among others.||
6298|263|I|   Taking MAO inhibitors with this medication may cause a serious||
6298|264|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
6298|265|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
6298|266|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
6298|267|I|selegiline, tranylcypromine) during treatment with this||
6298|268|I|medication. Most MAO inhibitors should also not be taken for two||
6298|269|I|weeks before treatment with this medication. Ask your doctor when||
6298|270|I|to start or stop taking this medication.||
6298|271|I|   The risk of serious side effects (such as slow/shallow||
6298|272|I|breathing, severe drowsiness/dizziness) may be increased if this||
6298|273|I|medication is used with other products that may also cause||
6298|274|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
6298|275|I|if you are taking other products such as other opioid pain or||
6298|276|I|cough relievers (such as codeine, hydrocodone), alcohol,||
6298|277|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
6298|278|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
6298|279|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
6298|280|I|cetirizine, diphenhydramine).||
6298|281|I|   Check the labels on all your medicines (such as allergy or||
6298|282|I|cough-and-cold products) because they may contain ingredients||
6298|283|I|that cause drowsiness. Ask your pharmacist about using those||
6298|284|I|products safely.||
6298|285|I|   The risk of serotonin syndrome/toxicity increases if you are||
6298|286|I|also taking other drugs that increase serotonin. Some examples||
6298|287|I|are street drugs such as MDMA/ "ecstasy," St. John's wort,||
6298|288|I|certain antidepressants (such as SSRIs like||
6298|289|I|fluoxetine/paroxetine, SNRIs like duloxetine/venlafaxine), among||
6298|290|I|others. The risk of serotonin syndrome/toxicity may be more||
6298|291|I|likely when you start or increase the dose of these drugs.||
6298|292|I|   This medication may interfere with certain lab tests (such as||
6298|293|I|amylase/lipase levels), possibly causing false test results. Make||
6298|294|I|sure lab personnel and all your doctors know you use this drug.||
6298|295|B|||
6298|296|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6298|297|O|as passing out or trouble breathing, give them naloxone or||
6298|298|O|nalmefene if available, then call 911. If the person is awake and||
6298|299|O|has no symptoms, call a poison control center right away. US||
6298|300|O|residents can call 1-800-222-1222. Canada residents can call||
6298|301|O|1-844-764-7669. Symptoms of overdose may include: slow breathing,||
6298|302|O|slow heartbeat, coma.||
6298|303|B|||
6298|304|N|NOTES:  Do not share this medication with others. Sharing it is||
6298|305|N|against the law.||
6298|306|N|   This medication has been prescribed for your current condition||
6298|307|N|only. Do not use it later for another condition unless told to do||
6298|308|N|so by your doctor. A different medication may be necessary in||
6298|309|N|that case.||
6298|310|B|||
6298|311|D|MISSED DOSE:  Not applicable.||
6298|312|B|||
6298|313|R|STORAGE:  Store at room temperature away from light and moisture.||
6298|314|R|Do not refrigerate or freeze. Do not store in the bathroom. Keep||
6298|315|R|all medications away from children and pets. See also Warning and||
6298|316|R|How to Use sections.||
6298|317|R|   Do not flush medications down the toilet or pour them into a||
6298|318|R|drain unless instructed to do so. Properly discard this product||
6298|319|R|when it is expired or no longer needed. For more details, read||
6298|320|R|the Medication Guide, or consult your pharmacist or local waste||
6298|321|R|disposal company.||
6298|322|B|||
6298|323|A|Information last revised August 2025.||
6298|324|A|Copyright(c) 2025 First Databank, Inc.||
6298|325|B|||
6300|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6300|002|Z|does NOT have all possible information about this product. This||
6300|003|Z|information does not assure that this product is safe, effective,||
6300|004|Z|or appropriate for you. This information is not individual||
6300|005|Z|medical advice and does not substitute for the advice of your||
6300|006|Z|health care professional. Always ask your health care||
6300|007|Z|professional for complete information about this product and your||
6300|008|Z|specific health needs.||
6300|009|B|||
6300|010|T|ESTRADIOL TABLET - VAGINAL||
6300|011|F|(ES-tra-DYE-ol)||
6300|012|B|||
6300|013|C|COMMON BRAND NAME(S): Vagifem||
6300|014|B|||
6300|015|W|WARNING:  Estrogens, either used alone or with another hormone||
6300|016|W|(progestin), have rarely caused very serious side effects.||
6300|017|W|Discuss the risks and benefits of hormone treatment with your||
6300|018|W|doctor. Estrogens should not be used to prevent heart disease or||
6300|019|W|dementia.||
6300|020|W|   Estrogens can increase the risk of cancer of the uterus||
6300|021|W|(endometrial cancer). Taking a progestin as directed by your||
6300|022|W|doctor can help decrease this risk. Tell your doctor right away||
6300|023|W|if you have any unusual vaginal bleeding.||
6300|024|W|   In postmenopausal women, estrogens can increase the risk of||
6300|025|W|cancer of the ovaries, stroke, dementia, and serious blood clots||
6300|026|W|in the legs. Estrogens alone do not appear to increase the risk||
6300|027|W|of breast cancer when used for up to 7 years. Estrogen, when used||
6300|028|W|with a progestin, can increase the risk of heart disease (such as||
6300|029|W|heart attacks), stroke, serious blood clots in the lungs/legs,||
6300|030|W|dementia, and cancer of the breast/ovaries.||
6300|031|W|   The risk for serious side effects may depend on the dose of||
6300|032|W|estrogen and the length of time it is used. This medication||
6300|033|W|should be used at the lowest effective dose and for the shortest||
6300|034|W|amount of time. Discuss the use of this medication with your||
6300|035|W|doctor and check with him/her regularly (for example, every 3 to||
6300|036|W|6 months) to see if you still need to take this medication. If||
6300|037|W|you will be taking this medication long-term, you should have||
6300|038|W|regular complete physical exams (for example, once a year) as||
6300|039|W|directed by your doctor. See also Notes section.||
6300|040|B|||
6300|041|U|USES:  This medication is a hormone (estrogen). It is used by||
6300|042|U|women to help reduce vaginal symptoms of menopause (such as||
6300|043|U|vaginal dryness/burning/itching). These symptoms are caused by||
6300|044|U|the body making less estrogen. When treating only vaginal||
6300|045|U|symptoms of menopause, products applied directly inside the||
6300|046|U|vagina (such as this medication) should be used first. Estrogens||
6300|047|U|that are taken by mouth, absorbed through the skin, or injected||
6300|048|U|may have greater risks of side effects due to more estrogen being||
6300|049|U|absorbed.||
6300|050|B|||
6300|051|H|HOW TO USE:  Read the Patient Information Leaflet and||
6300|052|H|Instructions for Use if available from your pharmacist before you||
6300|053|H|start using this medication and each time you get a refill. If||
6300|054|H|you have any questions, ask your doctor or pharmacist.||
6300|055|H|   Use this medication as directed by your doctor, usually once||
6300|056|H|daily for the first 2 weeks, and then 2 times a week thereafter.||
6300|057|H|The applicator comes packaged with the tablet inside. If the||
6300|058|H|tablet falls out before using, throw it away and use a new||
6300|059|H|applicator/tablet. Gently insert the applicator into the vagina||
6300|060|H|as directed and press the plunger to release the medication.||
6300|061|H|Throw away the applicator after use.||
6300|062|H|   The dosage is based on your medical condition and response to||
6300|063|H|treatment.||
6300|064|H|   Use this medication regularly to get the most benefit from it.||
6300|065|H|Follow your dosing schedule carefully. Do not increase your dose||
6300|066|H|or use this medication more often or for a longer time than||
6300|067|H|directed.||
6300|068|H|   Tell your doctor if your condition does not get better or if||
6300|069|H|it gets worse.||
6300|070|B|||
6300|071|S|SIDE EFFECTS:  See also Warning section.||
6300|072|S|   Nausea/vomiting, bloating, diarrhea, breast tenderness,||
6300|073|S|headache, or weight changes may occur. If any of these effects||
6300|074|S|last or get worse, tell your doctor or pharmacist promptly.||
6300|075|S|   Remember that this medication has been prescribed because your||
6300|076|S|doctor has judged that the benefit to you is greater than the||
6300|077|S|risk of side effects. Many people using this medication do not||
6300|078|S|have serious side effects.||
6300|079|S|   Tell your doctor right away if you have any serious side||
6300|080|S|effects, including: nausea/vomiting that doesn't stop,||
6300|081|S|mental/mood changes (such as depression, memory loss), breast||
6300|082|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
6300|083|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
6300|084|S|irritation/itching/odor/discharge, signs of liver problems (such||
6300|085|S|as stomach/abdominal pain, yellowing eyes/skin, dark urine),||
6300|086|S|swelling hands/ankles/feet, increased thirst/urination.||
6300|087|S|   This medication may rarely cause serious (sometimes fatal)||
6300|088|S|problems from blood clots (such as heart attack, stroke, blood||
6300|089|S|clots in the lungs or legs). Get medical help right away if you||
6300|090|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
6300|091|S|headaches, weakness on one side of the body, confusion, trouble||
6300|092|S|speaking, sudden vision changes, pain/swelling/warmth in the||
6300|093|S|groin/calf, shortness of breath/rapid breathing, sudden||
6300|094|S|dizziness/fainting.||
6300|095|S|   A very serious allergic reaction to this product is rare.||
6300|096|S|However, get medical help right away if you notice any symptoms||
6300|097|S|of a serious allergic reaction, including: rash, itching/swelling||
6300|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6300|099|S|breathing.||
6300|100|S|   This is not a complete list of possible side effects. If you||
6300|101|S|notice other effects not listed above, contact your doctor or||
6300|102|S|pharmacist.||
6300|103|S|   In the US -||
6300|104|S|   Call your doctor for medical advice about side effects. You||
6300|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6300|106|S|www.fda.gov/medwatch.||
6300|107|S|   In Canada - Call your doctor for medical advice about side||
6300|108|S|effects. You may report side effects to Health Canada at||
6300|109|S|1-866-234-2345.||
6300|110|B|||
6300|111|P|PRECAUTIONS:  Before using estradiol, tell your doctor or||
6300|112|P|pharmacist if you are allergic to it; or if you have any other||
6300|113|P|allergies. This product may contain inactive ingredients, which||
6300|114|P|can cause allergic reactions or other problems. Talk to your||
6300|115|P|pharmacist for more details.||
6300|116|P|   Before using this medication, tell your doctor or pharmacist||
6300|117|P|your medical history, especially of: vaginal bleeding of unknown||
6300|118|P|cause, certain cancers (such as breast cancer, cancer of the||
6300|119|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
6300|120|P|heart attack), liver disease, kidney disease, family medical||
6300|121|P|history (especially breast lumps, cancer, blood clots), family or||
6300|122|P|personal history of a certain swelling disorder (angioedema),||
6300|123|P|blood clotting disorders (such as protein C or protein S||
6300|124|P|deficiency), high blood pressure, diabetes, high||
6300|125|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
6300|126|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
6300|127|P|calcium in the blood), a certain hormone problem||
6300|128|P|(hypoparathyroidism), uterus problems (such as fibroids,||
6300|129|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
6300|130|P|headaches, mental/mood disorders (such as dementia, depression),||
6300|131|P|a certain blood disorder (porphyria).||
6300|132|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
6300|133|P|further increases your risk of stroke, blood clots, high blood||
6300|134|P|pressure, and heart attack, especially in women older than 35.||
6300|135|P|   Tell your doctor if you just had or will be having surgery, or||
6300|136|P|if you will be confined to a chair or bed for a long time (such||
6300|137|P|as a long plane flight). These conditions increase your risk of||
6300|138|P|getting blood clots, especially if you are using an estrogen||
6300|139|P|product. You may need to stop this medication for a time or take||
6300|140|P|special precautions.||
6300|141|P|   This medication may cause blotchy, dark areas on your face and||
6300|142|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
6300|143|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
6300|144|P|wear protective clothing when outdoors.||
6300|145|P|   If you are nearsighted or wear contact lenses, you may develop||
6300|146|P|vision problems or trouble wearing your contact lenses. Contact||
6300|147|P|your eye doctor if these problems occur.||
6300|148|P|   This medication should not be used during pregnancy. If you||
6300|149|P|become pregnant or think you may be pregnant, tell your doctor||
6300|150|P|right away.||
6300|151|P|   This medication passes into breast milk. Consult your doctor||
6300|152|P|before breastfeeding.||
6300|153|B|||
6300|154|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6300|155|I|medications work or increase your risk for serious side effects.||
6300|156|I|This document does not contain all possible drug interactions.||
6300|157|I|Keep a list of all the products you use (including||
6300|158|I|prescription/nonprescription drugs and herbal products) and share||
6300|159|I|it with your doctor and pharmacist. Do not start, stop, or change||
6300|160|I|the dosage of any medicines without your doctor's approval.||
6300|161|I|   Some products that may interact with this drug include:||
6300|162|I|fezolinetant, fulvestrant, ospemifene, raloxifene, tamoxifen,||
6300|163|I|toremifene, tranexamic acid.||
6300|164|I|   This medication may interfere with certain lab tests, possibly||
6300|165|I|causing false test results. Make sure lab personnel and all your||
6300|166|I|doctors know you use this drug.||
6300|167|B|||
6300|168|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
6300|169|O|has overdosed and has serious symptoms such as passing out or||
6300|170|O|trouble breathing, call 911. Otherwise, call a poison control||
6300|171|O|center right away. US residents can call 1-800-222-1222. Canada||
6300|172|O|residents can call 1-844-764-7669. Symptoms of overdose may||
6300|173|O|include: severe nausea/vomiting, unusual vaginal bleeding.||
6300|174|B|||
6300|175|N|NOTES:  Do not share this medication with others.||
6300|176|N|   Regular complete physical exams which include lab and/or||
6300|177|N|medical tests (such as blood pressure, breast exam/mammogram,||
6300|178|N|pelvic exam, Pap smear) should be done while you are using this||
6300|179|N|medication. Follow your doctor's instructions for examining your||
6300|180|N|breasts, and report any lumps right away. Keep all medical and||
6300|181|N|lab appointments. Consult your doctor for more details.||
6300|182|N|   Preventing or controlling high blood pressure, high||
6300|183|N|cholesterol, and diabetes can help to reduce your chances of||
6300|184|N|heart disease and stroke. Lifestyle changes that can help to||
6300|185|N|control or prevent these diseases include reducing stress, eating||
6300|186|N|a low fat/salt diet, losing weight if overweight, exercising||
6300|187|N|regularly, and stopping smoking. Keep your mind active with||
6300|188|N|mental exercises (such as reading, solving crossword puzzles) to||
6300|189|N|help prevent dementia. Talk to your doctor about lifestyle||
6300|190|N|changes that might benefit you.||
6300|191|B|||
6300|192|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6300|193|D|If it is near the time of the next dose, skip the missed dose.||
6300|194|D|Use your next dose at the regular time. Do not double the dose to||
6300|195|D|catch up.||
6300|196|B|||
6300|197|R|STORAGE:  Store at room temperature away from light and moisture.||
6300|198|R|Do not refrigerate. Do not store in the bathroom. Keep all||
6300|199|R|medications away from children and pets.||
6300|200|R|   Do not flush medications down the toilet or pour them into a||
6300|201|R|drain unless instructed to do so. Properly discard this product||
6300|202|R|when it is expired or no longer needed. Consult your pharmacist||
6300|203|R|or local waste disposal company.||
6300|204|B|||
6300|205|A|Information last revised November 2025.||
6300|206|A|Copyright(c) 2025 First Databank, Inc.||
6300|207|B|||
6301|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6301|002|Z|does NOT have all possible information about this product. This||
6301|003|Z|information does not assure that this product is safe, effective,||
6301|004|Z|or appropriate for you. This information is not individual||
6301|005|Z|medical advice and does not substitute for the advice of your||
6301|006|Z|health care professional. Always ask your health care||
6301|007|Z|professional for complete information about this product and your||
6301|008|Z|specific health needs.||
6301|009|B|||
6301|010|T|MYCOPHENOLATE MOFETIL - INJECTION||
6301|011|F|(MYE-koe-FEN-oh-late MOE-fe-til)||
6301|012|B|||
6301|013|C|COMMON BRAND NAME(S): Cellcept||
6301|014|B|||
6301|015|W|WARNING:  Mycophenolate may lower your ability to fight||
6301|016|W|infections. This may make you more likely to get a serious||
6301|017|W|(rarely fatal) infection or make any infection you have worse.||
6301|018|W|Tell your doctor right away if you have any signs of infection||
6301|019|W|(such as sore throat that doesn't go away, fever, chills,||
6301|020|W|burning/painful/urgent urination, change in the amount of urine).||
6301|021|W|   Mycophenolate may rarely cause cancer (such as lymphoma, skin||
6301|022|W|cancer). Protect your skin from the sun. Avoid prolonged sun||
6301|023|W|exposure, tanning booths, and sunlamps. Use a sunscreen and wear||
6301|024|W|protective clothing when outdoors. Tell your doctor right away if||
6301|025|W|you have any of the following symptoms of cancer: swollen lymph||
6301|026|W|nodes, sudden weight loss, night sweats, change in appearance or||
6301|027|W|size of moles, or unusual skin changes/growth.||
6301|028|W|   Mycophenolate may harm an unborn baby. When using||
6301|029|W|mycophenolate, men and women must use reliable forms of birth||
6301|030|W|control. See also Precautions section.||
6301|031|B|||
6301|032|U|USES:  Mycophenolate is used in combination with other||
6301|033|U|medications to keep your body from attacking and rejecting your||
6301|034|U|transplanted organ (such as kidney, liver, heart). It belongs to||
6301|035|U|a class of medications called immunosuppressants. It works by||
6301|036|U|weakening your body's defense system (immune system) to help your||
6301|037|U|body accept the new organ as if it were your own.||
6301|038|B|||
6301|039|V|OTHER USES:  This section contains uses of this drug that are not||
6301|040|V|listed in the approved professional labeling for the drug but||
6301|041|V|that may be prescribed by your health care professional. Use this||
6301|042|V|drug for a condition that is listed in this section only if it||
6301|043|V|has been so prescribed by your health care professional.||
6301|044|V|   This drug may also be used for immune system disorders.||
6301|045|B|||
6301|046|H|HOW TO USE:  Read the Medication Guide provided by your||
6301|047|H|pharmacist before you start using mycophenolate and each time you||
6301|048|H|get a refill. If you have any questions, ask your doctor or||
6301|049|H|pharmacist.||
6301|050|H|   This medication is given by injection into a vein (IV) by a||
6301|051|H|healthcare professional. It is given as directed by your doctor,||
6301|052|H|usually twice daily. It is injected slowly over at least two||
6301|053|H|hours. Mycophenolate must not be given by bolus or rapid IV||
6301|054|H|injection. When you are able to take medications by mouth, you||
6301|055|H|may be switched to an oral form of this medication.||
6301|056|H|   The injection form of this medication should not be used for||
6301|057|H|longer than 2 weeks unless you are directed to do so by the||
6301|058|H|doctor.||
6301|059|H|   Avoid getting the prepared liquid on your skin or in your||
6301|060|H|eyes. If contact occurs, wash the affected skin area well with||
6301|061|H|soap and water or rinse your eyes with plain water.||
6301|062|H|   Since this drug can be absorbed through the skin and may harm||
6301|063|H|an unborn baby, women who are pregnant or who may become pregnant||
6301|064|H|should not handle this medication.||
6301|065|H|   Use this medication regularly to get the most benefit from it.||
6301|066|H|To help you remember, use it at the same times each day. The||
6301|067|H|dosage is based on your medical condition and response to||
6301|068|H|treatment.||
6301|069|H|   Keep using this medication even if you feel well. Do not stop||
6301|070|H|using mycophenolate without first talking to your doctor.||
6301|071|B|||
6301|072|S|SIDE EFFECTS:  See also Warning section.||
6301|073|S|   Constipation, nausea, headache, diarrhea, vomiting, stomach||
6301|074|S|upset, gas, dizziness, drowsiness, trouble sleeping, tremor, or||
6301|075|S|redness/swelling at the injection site may occur. If any of these||
6301|076|S|effects last or get worse, tell your doctor or pharmacist||
6301|077|S|promptly.||
6301|078|S|   Remember that this medication has been prescribed because your||
6301|079|S|doctor has judged that the benefit to you is greater than the||
6301|080|S|risk of side effects. Many people using this medication do not||
6301|081|S|have serious side effects.||
6301|082|S|   Tell your doctor right away if you have any serious side||
6301|083|S|effects, including: unusual tiredness, fast/irregular heartbeat,||
6301|084|S|easy bleeding/bruising, swelling of the feet or ankles, joint||
6301|085|S|pain/stiffness, muscle pain.||
6301|086|S|   Get medical help right away if you have any very serious side||
6301|087|S|effects, including: stomach/abdominal pain that doesn't go away,||
6301|088|S|black stools, vomit that looks like coffee grounds, chest pain,||
6301|089|S|shortness of breath/rapid breathing.||
6301|090|S|   This medication may increase your risk of getting a rare but||
6301|091|S|very serious (possibly fatal) brain infection (progressive||
6301|092|S|multifocal leukoencephalopathy-PML). Get medical help right away||
6301|093|S|if you have any of these side effects: clumsiness, loss of||
6301|094|S|coordination/balance, weakness, sudden change in your thinking||
6301|095|S|(such as confusion, difficulty concentrating, memory loss),||
6301|096|S|difficulty talking/walking, seizure, vision changes.||
6301|097|S|   A very serious allergic reaction to this drug is rare.||
6301|098|S|However, get medical help right away if you notice any symptoms||
6301|099|S|of a serious allergic reaction, including: rash, itching/swelling||
6301|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6301|101|S|breathing.||
6301|102|S|   This is not a complete list of possible side effects. If you||
6301|103|S|notice other effects not listed above, contact your doctor or||
6301|104|S|pharmacist.||
6301|105|S|   In the US -||
6301|106|S|   Call your doctor for medical advice about side effects. You||
6301|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6301|108|S|www.fda.gov/medwatch.||
6301|109|S|   In Canada - Call your doctor for medical advice about side||
6301|110|S|effects. You may report side effects to Health Canada at||
6301|111|S|1-866-234-2345.||
6301|112|B|||
6301|113|P|PRECAUTIONS:  See also Warning section.||
6301|114|P|   Before using mycophenolate mofetil, tell your doctor or||
6301|115|P|pharmacist if you are allergic to it; or to mycophenolic acid; or||
6301|116|P|to mycophenolate sodium; or if you have any other allergies. This||
6301|117|P|product may contain inactive ingredients (such as Polysorbate||
6301|118|P|80), which can cause allergic reactions or other problems. Talk||
6301|119|P|to your pharmacist for more details.||
6301|120|P|   Before using this medication, tell your doctor or pharmacist||
6301|121|P|your medical history, especially of: cancer, liver disease (such||
6301|122|P|as hepatitis B, hepatitis C), kidney disease, current/past||
6301|123|P|infections (such as herpes, shingles), stomach/intestinal||
6301|124|P|problems (such as ulcers), rare genetic disorders (such as||
6301|125|P|Lesch-Nyhan or Kelley-Seegmiller syndromes).||
6301|126|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6301|127|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6301|128|P|machinery, or do anything that needs alertness until you can do||
6301|129|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
6301|130|P|are using marijuana (cannabis).||
6301|131|P|   Mycophenolate can make you more likely to get infections or||
6301|132|P|may make current infections worse. Stay away from anyone who has||
6301|133|P|an infection that may easily spread (such as chickenpox,||
6301|134|P|COVID-19, measles, flu). Talk to your doctor if you have been||
6301|135|P|exposed to an infection or for more details.||
6301|136|P|   Tell your health care professional that you are using||
6301|137|P|mycophenolate mofetil before having any||
6301|138|P|immunizations/vaccinations. Avoid contact with people who have||
6301|139|P|recently received live vaccines (such as flu vaccine inhaled||
6301|140|P|through the nose).||
6301|141|P|   To lower the chance of getting cut, bruised, or injured, use||
6301|142|P|caution with sharp objects like razors and nail cutters, and||
6301|143|P|avoid activities such as contact sports.||
6301|144|P|   Before having surgery, tell your doctor or dentist about all||
6301|145|P|the products you use (including prescription drugs,||
6301|146|P|nonprescription drugs, and herbal products).||
6301|147|P|   Do not donate blood while using mycophenolate and for 6 weeks||
6301|148|P|after stopping this drug. Do not donate sperm while using||
6301|149|P|mycophenolate and for 90 days after stopping this drug.||
6301|150|P|   Since this drug can be absorbed through the skin and may harm||
6301|151|P|an unborn baby, women who are pregnant or who may become pregnant||
6301|152|P|should not handle this medication.||
6301|153|P|   Tell your doctor if you are pregnant or plan to become||
6301|154|P|pregnant. You should not become pregnant while using||
6301|155|P|mycophenolate. Mycophenolate may harm an unborn baby. Your doctor||
6301|156|P|should order a pregnancy test before you start this medication.||
6301|157|P|Women using this medication should ask about reliable forms of||
6301|158|P|birth control during treatment and for 6 weeks after the last||
6301|159|P|dose. Men using this medication should ask about reliable forms||
6301|160|P|of birth control during treatment and for 3 months after the last||
6301|161|P|dose. If you or your partner becomes pregnant, talk to your||
6301|162|P|doctor right away about the risks and benefits of this||
6301|163|P|medication.||
6301|164|P|   It is unknown if this drug passes into breast milk. Because of||
6301|165|P|the possible risk to the infant, breastfeeding is not recommended||
6301|166|P|while using this drug. Consult your doctor before breastfeeding.||
6301|167|B|||
6301|168|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6301|169|I|medications work or increase your risk for serious side effects.||
6301|170|I|This document does not contain all possible drug interactions.||
6301|171|I|Keep a list of all the products you use (including||
6301|172|I|prescription/nonprescription drugs and herbal products) and share||
6301|173|I|it with your doctor and pharmacist. Do not start, stop, or change||
6301|174|I|the dosage of any medicines without your doctor's approval.||
6301|175|I|   Some products that may interact with this drug include:||
6301|176|I|cholestyramine, colestipol, other drugs that weaken the immune||
6301|177|I|system/increase the risk of infection (such as natalizumab,||
6301|178|I|rituximab).||
6301|179|I|   This medication may decrease the effectiveness of hormonal||
6301|180|I|birth control such as pills, patch, or ring. This could cause||
6301|181|I|pregnancy. Discuss with your doctor or pharmacist about using a||
6301|182|I|reliable backup birth control method while using this medication.||
6301|183|I|Also tell your doctor if you have any new spotting or||
6301|184|I|breakthrough bleeding, because these may be signs that your birth||
6301|185|I|control is not working well.||
6301|186|B|||
6301|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6301|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6301|189|O|poison control center right away. US residents can call||
6301|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6301|191|B|||
6301|192|N|NOTES:  Lab and/or medical tests (such as blood counts, drug||
6301|193|N|levels, kidney function, pregnancy test) should be done while you||
6301|194|N|are taking this medication. Keep all medical and lab||
6301|195|N|appointments. Consult your doctor for more details.||
6301|196|N|   Attend a transplant education class or support group. Learn to||
6301|197|N|recognize the signs and symptoms of organ rejection and tell your||
6301|198|N|doctor right away if they occur.||
6301|199|B|||
6301|200|D|MISSED DOSE:  It is important to get each dose of this medication||
6301|201|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6301|202|D|right away for a new dosing schedule.||
6301|203|B|||
6301|204|R|STORAGE:  Not applicable. This medication is given in a clinic||
6301|205|R|and will not be stored at home.||
6301|206|B|||
6301|207|M|MEDICAL ALERT:  Your condition can cause complications in a||
6301|208|M|medical emergency. For information about enrolling in MedicAlert,||
6301|209|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6301|210|B|||
6301|211|A|Information last revised May 2025.||
6301|212|A|Copyright(c) 2025 First Databank, Inc.||
6301|213|B|||
6303|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6303|002|Z|does NOT have all possible information about this product. This||
6303|003|Z|information does not assure that this product is safe, effective,||
6303|004|Z|or appropriate for you. This information is not individual||
6303|005|Z|medical advice and does not substitute for the advice of your||
6303|006|Z|health care professional. Always ask your health care||
6303|007|Z|professional for complete information about this product and your||
6303|008|Z|specific health needs.||
6303|009|B|||
6303|010|T|HEPATITIS A/HEPATITIS B VACCINE - INJECTION||
6303|011|F|(HEP-a-TYE-tis/HEP-a-TYE-tis vak-SEEN)||
6303|012|B|||
6303|013|C|COMMON BRAND NAME(S): Twinrix||
6303|014|B|||
6303|015|U|USES:  This vaccine is used to help prevent hepatitis A and B.||
6303|016|U|Hepatitis A infection can be mild with no symptoms or a severe||
6303|017|U|illness that can rarely cause liver failure and death. Hepatitis||
6303|018|U|B infection can cause serious problems including liver failure,||
6303|019|U|long-term hepatitis B infection, cirrhosis, and liver cancer.||
6303|020|U|Vaccination is the best way to protect against these infections.||
6303|021|U|This vaccine works by increasing the body's natural defense||
6303|022|U|(immunity) against the viruses.||
6303|023|U|   This vaccine is recommended for people at an increased risk of||
6303|024|U|getting these infections. Those at an increased risk include||
6303|025|U|health care personnel, lab workers who handle blood and patient||
6303|026|U|specimens, police, fire and emergency medical personnel who give||
6303|027|U|first aid treatment, hemophiliacs, dialysis patients, people who||
6303|028|U|live with or spend much time with people with long-term hepatitis||
6303|029|U|B or active hepatitis A infections, people with multiple sex||
6303|030|U|partners, men who have sex with men, sex workers, injection drug||
6303|031|U|abusers, and people traveling to high-risk areas.||
6303|032|U|   Vaccines may not fully protect everyone who receives them.||
6303|033|B|||
6303|034|H|HOW TO USE:  Read all vaccine information available from your||
6303|035|H|health care professional before receiving the vaccine. If you||
6303|036|H|have any questions, ask your health care professional.||
6303|037|H|   This vaccine is given by injection into a muscle by a health||
6303|038|H|care professional. It is given in the upper arm for children and||
6303|039|H|adults and in the thigh for infants.||
6303|040|H|   Vaccines are usually given in a series of doses to provide the||
6303|041|H|best protection. Closely follow the vaccination schedule provided||
6303|042|H|by your health care professional. To help you remember, mark your||
6303|043|H|calendar with a reminder.||
6303|044|H|   This vaccine may be given at the same time as other vaccines.||
6303|045|B|||
6303|046|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
6303|047|S|fever, tiredness, headache, nausea, and diarrhea may occur. If||
6303|048|S|any of these effects last or get worse, tell your health care||
6303|049|S|professional promptly.||
6303|050|S|   Rarely, some people have symptoms such as fainting, dizziness,||
6303|051|S|vision changes, or ringing in the ears just after getting a||
6303|052|S|vaccine injection. Tell your health care professional right away||
6303|053|S|if you have any of these symptoms. Sitting or lying down may||
6303|054|S|help, since these symptoms usually don't last long.||
6303|055|S|   Remember that this vaccine has been prescribed because your||
6303|056|S|health care professional has judged that the benefit to you is||
6303|057|S|greater than the risk of side effects. Many people using this||
6303|058|S|vaccine do not have serious side effects.||
6303|059|S|   A very serious allergic reaction to this vaccine is rare.||
6303|060|S|However, get medical help right away if you notice any symptoms||
6303|061|S|of a serious allergic reaction, including: rash, itching/swelling||
6303|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6303|063|S|breathing.||
6303|064|S|   This is not a complete list of possible side effects. If you||
6303|065|S|notice other effects not listed above, contact your health care||
6303|066|S|professional.||
6303|067|S|   Contact the health care professional for medical advice about||
6303|068|S|side effects. The following numbers do not provide medical||
6303|069|S|advice, but in the US you may report side effects to the Vaccine||
6303|070|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
6303|071|S|Canada, you may call the Vaccine Safety Section at Public Health||
6303|072|S|Agency of Canada at 1-866-844-0018.||
6303|073|B|||
6303|074|P|PRECAUTIONS:  Before you receive this vaccine, tell your health||
6303|075|P|care professional if you are allergic to it; or if you have any||
6303|076|P|other allergies. This product may contain inactive ingredients||
6303|077|P|(such as latex rubber found in some brands, yeast, neomycin,||
6303|078|P|formalin), which can cause allergic reactions or other problems.||
6303|079|P|Talk to your health care professional for more details.||
6303|080|P|   Before receiving this vaccine, tell your health care||
6303|081|P|professional your medical history, especially of: current||
6303|082|P|fever/illness, immune system disorders (such as due to HIV||
6303|083|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
6303|084|P|radiation treatment), vaccination history (including previous||
6303|085|P|reactions to any vaccines).||
6303|086|P|   Older adults and people on dialysis may not respond as well to||
6303|087|P|the vaccine. Talk to your health care professional for more||
6303|088|P|details.||
6303|089|P|   During pregnancy, this vaccine should be used only when||
6303|090|P|clearly needed. Discuss the risks and benefits with your health||
6303|091|P|care professional.||
6303|092|P|   It is unknown if this vaccine passes into breast milk. Consult||
6303|093|P|your health care professional before breastfeeding.||
6303|094|B|||
6303|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6303|096|I|medications work or increase your risk for serious side effects.||
6303|097|I|This document does not contain all possible drug interactions.||
6303|098|I|Keep a list of all the products you use (including||
6303|099|I|prescription/nonprescription drugs and herbal products) and share||
6303|100|I|it with your health care professional. Do not start, stop, or||
6303|101|I|change the dosage of any medicines without your doctor's||
6303|102|I|approval.||
6303|103|I|   Some products that may interact with this vaccine are: drugs||
6303|104|I|that weaken the immune system (including cyclosporine,||
6303|105|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
6303|106|I|prednisone).||
6303|107|B|||
6303|108|O|OVERDOSE:  Not applicable.||
6303|109|B|||
6303|110|N|NOTES:  Lab and/or medical tests (such as hepatitis A or B||
6303|111|N|antibody levels) may be done while you are using this vaccine.||
6303|112|N|Keep all medical and lab appointments. Consult your health care||
6303|113|N|professional for more details.||
6303|114|N|   Keep vaccine records for yourself and your children and||
6303|115|N|provide them to the health care professionals to prevent||
6303|116|N|unnecessary re-vaccinations.||
6303|117|B|||
6303|118|D|MISSED DOSE:  It is important that you get each vaccination as||
6303|119|D|scheduled. Ask when you should get each dose and mark your||
6303|120|D|calendar with a reminder. If you miss a dose, call the health||
6303|121|D|care professional to reschedule.||
6303|122|B|||
6303|123|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
6303|124|R|medications away from children and pets.||
6303|125|R|   Do not flush medications down the toilet or pour them into a||
6303|126|R|drain unless instructed to do so. Properly discard this product||
6303|127|R|when it is expired or no longer needed. Consult your pharmacist||
6303|128|R|or local waste disposal company.||
6303|129|B|||
6303|130|A|Information last revised January 2025.||
6303|131|A|Copyright(c) 2025 First Databank, Inc.||
6303|132|B|||
6304|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6304|002|Z|does NOT have all possible information about this product. This||
6304|003|Z|information does not assure that this product is safe, effective,||
6304|004|Z|or appropriate for you. This information is not individual||
6304|005|Z|medical advice and does not substitute for the advice of your||
6304|006|Z|health care professional. Always ask your health care||
6304|007|Z|professional for complete information about this product and your||
6304|008|Z|specific health needs.||
6304|009|B|||
6304|010|T|FLUTICASONE/SALMETEROL INHALER - ORAL INHALATION||
6304|011|F|(floo-TIK-a-sone/sal-MEE-ter-ol)||
6304|012|B|||
6304|013|C|COMMON BRAND NAME(S): Advair Diskus, Wixela Inhub||
6304|014|B|||
6304|015|U|USES:  This product is used to control and prevent symptoms||
6304|016|U|(wheezing and shortness of breath) caused by asthma or ongoing||
6304|017|U|lung disease (chronic obstructive pulmonary disease-COPD, which||
6304|018|U|includes chronic bronchitis and emphysema). It contains 2||
6304|019|U|medications: fluticasone and salmeterol. Fluticasone belongs to a||
6304|020|U|class of drugs known as corticosteroids. It works by reducing the||
6304|021|U|irritation and swelling of the airways. Salmeterol belongs to the||
6304|022|U|class of drugs known as long-acting beta agonists. It works by||
6304|023|U|relaxing the muscles around the airways so that they open up and||
6304|024|U|you can breathe more easily. Controlling symptoms of breathing||
6304|025|U|problems can decrease time lost from work or school.||
6304|026|U|   When used alone, long-acting beta agonists (such as||
6304|027|U|salmeterol) may rarely increase the risk of serious (sometimes||
6304|028|U|fatal) asthma-related breathing problems. However, combination||
6304|029|U|inhaled corticosteroid and long-acting beta agonists, such as||
6304|030|U|this product, do not increase the risk of serious asthma-related||
6304|031|U|breathing problems. For asthma treatment, this product should be||
6304|032|U|used when breathing problems are not well controlled with one||
6304|033|U|asthma-control medication (such as inhaled corticosteroid) or if||
6304|034|U|your symptoms need combination treatment.||
6304|035|U|   Before using this medication, it is important to learn how to||
6304|036|U|use it properly. This medication must be used regularly to be||
6304|037|U|effective. It does not work right away and should not be used to||
6304|038|U|relieve sudden asthma attacks. If an asthma attack occurs, use||
6304|039|U|your quick-relief inhaler (such as albuterol, also called||
6304|040|U|salbutamol in some countries) as prescribed.||
6304|041|B|||
6304|042|H|HOW TO USE:  Read the Patient Information Leaflet and||
6304|043|H|Instructions for Use provided by your pharmacist before you start||
6304|044|H|using this medication and each time you get a refill. Follow the||
6304|045|H|illustrated directions for the proper use of this medication. If||
6304|046|H|you have any questions, ask your doctor or pharmacist.||
6304|047|H|   Depending on your brand, the inhaler should be used in a||
6304|048|H|level, flat position or in a vertical position. Inhale this||
6304|049|H|medication by mouth as directed by your doctor, usually twice||
6304|050|H|daily (in the morning and evening, 12 hours apart). You may or||
6304|051|H|may not taste/feel the drug when you inhale. Either is normal. Do||
6304|052|H|not exhale into the device.||
6304|053|H|   Do not take the inhaler apart or wash the mouthpiece or any||
6304|054|H|part of the device. Close the device after each use.||
6304|055|H|   If you are using other inhalers at the same time, wait at||
6304|056|H|least 1 minute between the use of each medication, and use this||
6304|057|H|drug last.||
6304|058|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
6304|059|H|from developing, gargle, rinse your mouth with water and spit out||
6304|060|H|after each use. Do not swallow the rinse water.||
6304|061|H|   The dosage is based on your medical condition, age, and||
6304|062|H|response to treatment.||
6304|063|H|   Use this medication regularly in order to get the most benefit||
6304|064|H|from it. This medication works best if used at evenly spaced||
6304|065|H|times. To help you remember, use it at the same times each day.||
6304|066|H|Do not increase your dose, use this medication more often, or||
6304|067|H|stop using it without talking with your doctor. Also, do not use||
6304|068|H|other long-acting beta agonists while using this medication.||
6304|069|H|   If you have been using a quick-relief inhaler (such as||
6304|070|H|albuterol, also called salbutamol in some countries) on a regular||
6304|071|H|daily schedule (such as 4 times daily), you must stop this||
6304|072|H|schedule and only use the quick-relief inhaler as needed for||
6304|073|H|sudden shortness of breath/asthma attacks. Consult your doctor||
6304|074|H|for details.||
6304|075|H|   If you are regularly taking a different corticosteroid by||
6304|076|H|mouth (such as prednisone), you should not stop taking it unless||
6304|077|H|directed by your doctor. Some conditions (such as asthma,||
6304|078|H|allergies) may become worse when the drug is suddenly stopped. If||
6304|079|H|you suddenly stop taking the drug, you may also have withdrawal||
6304|080|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
6304|081|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
6304|082|H|doctor may slowly lower the dose of your old medication after you||
6304|083|H|begin using fluticasone/salmeterol. Tell your doctor or||
6304|084|H|pharmacist right away if you have withdrawal. See also||
6304|085|H|Precautions section.||
6304|086|H|   It may take 1 week or longer before you get the full benefit||
6304|087|H|of this drug. Tell your doctor if your condition does not get||
6304|088|H|better or if it gets worse.||
6304|089|H|   Learn which of your inhalers you should use every day||
6304|090|H|(controller drugs) and which you should use if your breathing||
6304|091|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
6304|092|H|time what you should do if you have new or worsening cough or||
6304|093|H|shortness of breath, wheezing, increased sputum, worsening peak||
6304|094|H|flow meter readings, waking up at night with trouble breathing,||
6304|095|H|if you use your quick-relief inhaler more often (more than 2 days||
6304|096|H|a week), or if your quick-relief inhaler does not seem to be||
6304|097|H|working well. Learn when you can treat sudden breathing problems||
6304|098|H|by yourself and when you must get medical help right away.||
6304|099|B|||
6304|100|S|SIDE EFFECTS:  Hoarseness, throat irritation, headache, or||
6304|101|S|stomach upset may occur. If any of these effects last or get||
6304|102|S|worse, tell your doctor promptly.||
6304|103|S|   Remember that this medication has been prescribed because your||
6304|104|S|doctor has judged that the benefit to you is greater than the||
6304|105|S|risk of side effects. Many people using this medication do not||
6304|106|S|have serious side effects.||
6304|107|S|   This medication may raise your blood pressure. Check your||
6304|108|S|blood pressure regularly and tell your doctor if the results are||
6304|109|S|high.||
6304|110|S|   Rarely, this medication may cause severe sudden worsening of||
6304|111|S|breathing problems/asthma immediately after use. If you have||
6304|112|S|sudden worsening of breathing, use your quick-relief inhaler and||
6304|113|S|get medical help right away.||
6304|114|S|   Tell your doctor right away if you have any serious side||
6304|115|S|effects, including: white patches on tongue/in mouth, signs of||
6304|116|S|infection (such as sore throat that doesn't go away, fever,||
6304|117|S|chills), mental/mood changes (such as nervousness), trouble||
6304|118|S|sleeping, vision problems (such as blurred vision), increased||
6304|119|S|thirst/urination, muscle cramps, shaking (tremors).||
6304|120|S|   Get medical help right away if you have any very serious side||
6304|121|S|effects, including: chest pain, fast/irregular heartbeat, severe||
6304|122|S|dizziness, fainting, seizures.||
6304|123|S|   A very serious allergic reaction to this product is rare.||
6304|124|S|However, get medical help right away if you notice any symptoms||
6304|125|S|of a serious allergic reaction, including: rash, itching/swelling||
6304|126|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6304|127|S|breathing.||
6304|128|S|   This is not a complete list of possible side effects. If you||
6304|129|S|notice other effects not listed above, contact your doctor or||
6304|130|S|pharmacist.||
6304|131|S|   In the US -||
6304|132|S|   Call your doctor for medical advice about side effects. You||
6304|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6304|134|S|www.fda.gov/medwatch.||
6304|135|S|   In Canada - Call your doctor for medical advice about side||
6304|136|S|effects. You may report side effects to Health Canada at||
6304|137|S|1-866-234-2345.||
6304|138|B|||
6304|139|P|PRECAUTIONS:  Before using this product, tell your doctor or||
6304|140|P|pharmacist if you are allergic to fluticasone or salmeterol; or||
6304|141|P|if you have any other allergies. This product may contain||
6304|142|P|inactive ingredients (such as lactose, milk proteins), which can||
6304|143|P|cause allergic reactions or other problems. Talk to your||
6304|144|P|pharmacist for more details.||
6304|145|P|   Before using this medication, tell your doctor or pharmacist||
6304|146|P|your medical history, especially of: current/past infections||
6304|147|P|(such as tuberculosis, herpes), high blood pressure, bone loss||
6304|148|P|(osteoporosis), heart disease (such as chest pain, heart attack,||
6304|149|P|irregular heartbeat), overactive thyroid (hyperthyroidism),||
6304|150|P|diabetes, eye problems (such as cataracts, glaucoma), seizures,||
6304|151|P|liver disease.||
6304|152|P|   Salmeterol may cause a condition that affects the heart rhythm||
6304|153|P|(QT prolongation). QT prolongation can rarely cause serious||
6304|154|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
6304|155|P|as severe dizziness, fainting) that need medical attention right||
6304|156|P|away.||
6304|157|P|   The risk of QT prolongation may be increased if you have||
6304|158|P|certain medical conditions or are taking other drugs that may||
6304|159|P|cause QT prolongation. Before using this product, tell your||
6304|160|P|doctor or pharmacist of all the drugs you take and if you have||
6304|161|P|any of the following conditions: certain heart problems (heart||
6304|162|P|failure, slow heartbeat, QT prolongation in the EKG), family||
6304|163|P|history of certain heart problems (QT prolongation in the EKG,||
6304|164|P|sudden cardiac death).||
6304|165|P|   Low levels of potassium or magnesium in the blood may also||
6304|166|P|increase your risk of QT prolongation. This risk may increase if||
6304|167|P|you use certain drugs (such as diuretics/"water pills") or if you||
6304|168|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6304|169|P|Talk to your doctor about using this medication safely.||
6304|170|P|   This medication may mask signs of infection. It can make you||
6304|171|P|more likely to get infections or may make current infections||
6304|172|P|worse. Stay away from anyone who has an infection that may easily||
6304|173|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
6304|174|P|doctor if you have been exposed to an infection or for more||
6304|175|P|details.||
6304|176|P|   If you have switched from a corticosteroid taken by mouth||
6304|177|P|(such as prednisone tablets) to this inhaler within the past 12||
6304|178|P|months, or if you have been using this product in||
6304|179|P|higher-than-usual doses for a long time, it may be more difficult||
6304|180|P|for your body to respond to physical stress. Before having||
6304|181|P|surgery or emergency treatment, or if you get a serious||
6304|182|P|illness/injury, tell your doctor or dentist that you are using||
6304|183|P|this medication or have used a corticosteroid taken by mouth||
6304|184|P|within the past 12 months. Tell your doctor right away if you||
6304|185|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
6304|186|P|card or medical ID bracelet that says you use (or have used)||
6304|187|P|corticosteroid medications.||
6304|188|P|   Before having surgery, tell your doctor or dentist about all||
6304|189|P|the products you use (including prescription drugs,||
6304|190|P|nonprescription drugs, and herbal products).||
6304|191|P|   Older adults with COPD may be at greater risk for pneumonia||
6304|192|P|while using this drug. Older adults may also be more sensitive to||
6304|193|P|the side effects of this drug, especially QT prolongation (see||
6304|194|P|above).||
6304|195|P|   This medication may temporarily slow down a child's growth if||
6304|196|P|used for a long time. However, poorly controlled asthma can also||
6304|197|P|slow down growth. See the doctor regularly so your child's height||
6304|198|P|can be checked.||
6304|199|P|   During pregnancy, this medication should be used only when||
6304|200|P|clearly needed. Discuss the risks and benefits with your doctor.||
6304|201|P|   It is unknown if this medication passes into breast milk.||
6304|202|P|Consult your doctor before breastfeeding.||
6304|203|B|||
6304|204|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6304|205|I|medications work or increase your risk for serious side effects.||
6304|206|I|This document does not contain all possible drug interactions.||
6304|207|I|Keep a list of all the products you use (including||
6304|208|I|prescription/nonprescription drugs and herbal products) and share||
6304|209|I|it with your doctor and pharmacist. Do not start, stop, or change||
6304|210|I|the dosage of any medicines without your doctor's approval.||
6304|211|I|   Some products that may interact with this drug include:||
6304|212|I|aldesleukin, desmopressin.||
6304|213|I|   Other medications can affect the removal of fluticasone and||
6304|214|I|salmeterol from your body, which may affect how this product||
6304|215|I|works. Examples include azole antifungals (such as ketoconazole),||
6304|216|I|cobicistat, macrolide antibiotics (such as clarithromycin), HIV||
6304|217|I|protease inhibitors (such as lopinavir), nefazodone, ritonavir,||
6304|218|I|telithromycin, among others.||
6304|219|B|||
6304|220|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6304|221|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6304|222|O|poison control center right away. US residents can call||
6304|223|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6304|224|O|Symptoms of overdose may include: shaking (tremors), chest pain,||
6304|225|O|fast/irregular heartbeat, seizures.||
6304|226|B|||
6304|227|N|NOTES:  Do not share this medication with others.||
6304|228|N|   Lab and/or medical tests (such as lung function, blood||
6304|229|N|pressure, bone density tests, eye exams) may be done while you||
6304|230|N|are using this medication. Keep all medical and lab appointments.||
6304|231|N|Consult your doctor for more details.||
6304|232|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
6304|233|N|mold that can worsen breathing problems. Because the flu virus||
6304|234|N|can also worsen breathing problems, ask your doctor or pharmacist||
6304|235|N|if you should have a flu shot every year.||
6304|236|N|   This medication may cause bone loss (osteoporosis) in adults||
6304|237|N|when used for a long time. Lifestyle changes that may help reduce||
6304|238|N|the risk of bone problems include doing weight-bearing exercise,||
6304|239|N|stopping smoking, limiting alcohol, and getting enough calcium||
6304|240|N|and vitamin D. Talk to your doctor for more details.||
6304|241|B|||
6304|242|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
6304|243|D|next dose at the regular time. Do not double the dose to catch||
6304|244|D|up.||
6304|245|B|||
6304|246|R|STORAGE:  Store at room temperature away from moisture and heat.||
6304|247|R|Do not store in the bathroom. Do not open the original foil||
6304|248|R|package until you are ready to use the medication. Once the foil||
6304|249|R|package is opened, this medication expires after 1 month. Keep||
6304|250|R|all medications away from children and pets.||
6304|251|R|   Do not flush medications down the toilet or pour them into a||
6304|252|R|drain unless instructed to do so. Properly discard this product||
6304|253|R|when it is expired or no longer needed. Consult your pharmacist||
6304|254|R|or local waste disposal company.||
6304|255|B|||
6304|256|M|MEDICAL ALERT:  Your condition can cause complications in a||
6304|257|M|medical emergency. For information about enrolling in MedicAlert,||
6304|258|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6304|259|B|||
6304|260|A|Information last revised September 2025.||
6304|261|A|Copyright(c) 2025 First Databank, Inc.||
6304|262|B|||
6309|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6309|002|Z|does NOT have all possible information about this product. This||
6309|003|Z|information does not assure that this product is safe, effective,||
6309|004|Z|or appropriate for you. This information is not individual||
6309|005|Z|medical advice and does not substitute for the advice of your||
6309|006|Z|health care professional. Always ask your health care||
6309|007|Z|professional for complete information about this product and your||
6309|008|Z|specific health needs.||
6309|009|B|||
6309|010|T|METFORMIN SUSTAINED-ACTION TABLET - ORAL||
6309|011|F|(met-FOR-min)||
6309|012|B|||
6309|013|C|COMMON BRAND NAME(S):  Glucophage XR, Fortamet, Glumetza||
6309|014|B|||
6309|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
6309|016|W|cause a serious (sometimes fatal) condition called lactic||
6309|017|W|acidosis. Lactic acidosis is more likely if you are an older||
6309|018|W|adult, if you have kidney or liver disease, dehydration, heart||
6309|019|W|failure, heavy alcohol use, if you have surgery, if you have||
6309|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
6309|021|W|you are using certain drugs. For some conditions, your doctor may||
6309|022|W|tell you to stop taking this medication for a short time. Ask||
6309|023|W|your doctor or pharmacist for more details.||
6309|024|W|   Stop taking this medication and get medical help right away if||
6309|025|W|you have any symptoms of lactic acidosis, such as unusual||
6309|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
6309|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
6309|028|W|or stomach pain with nausea/vomiting/diarrhea.||
6309|029|B|||
6309|030|U|USES:  Metformin is used with a proper diet and exercise program||
6309|031|U|and possibly with other medications to control high blood sugar.||
6309|032|U|It is used in patients with type 2 diabetes. Controlling high||
6309|033|U|blood sugar helps prevent kidney damage, blindness, nerve||
6309|034|U|problems, loss of limbs, and sexual function problems. Proper||
6309|035|U|control of diabetes may also lessen your risk of a heart attack||
6309|036|U|or stroke. Metformin works by helping to restore your body's||
6309|037|U|proper response to the insulin you naturally produce. It also||
6309|038|U|decreases the amount of sugar that your liver makes and that your||
6309|039|U|stomach/intestines absorb.||
6309|040|B|||
6309|041|V|OTHER USES:  This section contains uses of this drug that are not||
6309|042|V|listed in the approved professional labeling for the drug but||
6309|043|V|that may be prescribed by your health care professional. Use this||
6309|044|V|drug for a condition that is listed in this section only if it||
6309|045|V|has been so prescribed by your health care professional.||
6309|046|V|   This drug may also be used with lifestyle changes such as diet||
6309|047|V|and exercise to keep people who are at high risk for diabetes||
6309|048|V|from becoming diabetic. It may also be used by women with a||
6309|049|V|certain disease of the ovaries (polycystic ovarian syndrome).||
6309|050|V|Metformin may make menstrual cycles more regular and increase||
6309|051|V|fertility.||
6309|052|B|||
6309|053|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6309|054|H|from your pharmacist before you start taking metformin and each||
6309|055|H|time you get a refill. If you have any questions, consult your||
6309|056|H|doctor or pharmacist.||
6309|057|H|   Take this medication by mouth as directed by your doctor,||
6309|058|H|usually once daily with the evening meal. Drink plenty of fluids||
6309|059|H|while taking this medication unless otherwise directed by your||
6309|060|H|doctor.||
6309|061|H|   Do not crush or chew this medication. Doing so can release all||
6309|062|H|of the drug at once, increasing the risk of side effects. Also,||
6309|063|H|do not split the tablets unless they have a score line and your||
6309|064|H|doctor or pharmacist tells you to do so. Swallow the whole or||
6309|065|H|split tablet without crushing or chewing.||
6309|066|H|   The dosage is based on your medical condition, response to||
6309|067|H|treatment, and other medications you may be taking. Be sure to||
6309|068|H|tell your doctor and pharmacist about all the products you use||
6309|069|H|(including prescription drugs, nonprescription drugs, and herbal||
6309|070|H|products). To reduce your risk of side effects (such as upset||
6309|071|H|stomach), your doctor may direct you to start this medication at||
6309|072|H|a low dose and gradually increase your dose. Follow your doctor's||
6309|073|H|instructions carefully.||
6309|074|H|   Take this medication regularly in order to get the most||
6309|075|H|benefit from it. Remember to use it at the same time each day.||
6309|076|H|   Tell your doctor if your condition does not get better or if||
6309|077|H|it gets worse (your blood sugar is too high or too low).||
6309|078|B|||
6309|079|S|SIDE EFFECTS:  See also Warning section.||
6309|080|S|   Nausea, vomiting, stomach upset, diarrhea, weakness, or a||
6309|081|S|metallic taste in the mouth may occur. If any of these effects||
6309|082|S|last or get worse, tell your doctor or pharmacist promptly. If||
6309|083|S|stomach symptoms return later (after taking the same dose for||
6309|084|S|several days or weeks), tell your doctor right away. Stomach||
6309|085|S|symptoms that occur after the first days of your treatment may be||
6309|086|S|signs of lactic acidosis.||
6309|087|S|   An empty tablet shell may appear in your stool. This effect is||
6309|088|S|harmless because your body has already absorbed the medication.||
6309|089|S|   Remember that this medication has been prescribed because your||
6309|090|S|doctor has judged that the benefit to you is greater than the||
6309|091|S|risk of side effects. Many people using this medication do not||
6309|092|S|have serious side effects.||
6309|093|S|   Metformin does not usually cause low blood sugar||
6309|094|S|(hypoglycemia). Low blood sugar may occur if this drug is||
6309|095|S|prescribed with other diabetes medications, or if you do not get||
6309|096|S|enough calories from food, or if you do unusually heavy exercise.||
6309|097|S|Talk with your doctor or pharmacist about whether the dose of||
6309|098|S|your other diabetes medication(s) needs to be lowered. Symptoms||
6309|099|S|of low blood sugar include sudden sweating, shaking, fast||
6309|100|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
6309|101|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
6309|102|S|treat low blood sugar. If you don't have these reliable forms of||
6309|103|S|glucose, rapidly raise your blood sugar by eating a quick source||
6309|104|S|of sugar such as table sugar, honey, or candy, or drink fruit||
6309|105|S|juice or non-diet soda. Tell your doctor right away about the||
6309|106|S|reaction and the use of this product. To help prevent low blood||
6309|107|S|sugar, eat meals on a regular schedule, and do not skip meals.||
6309|108|S|Check with your doctor or pharmacist to find out what you should||
6309|109|S|do if you miss a meal.||
6309|110|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
6309|111|S|thirst/urination. If these symptoms occur, tell your doctor right||
6309|112|S|away. Your doctor may need to adjust your diabetes medication,||
6309|113|S|exercise program, or diet.||
6309|114|S|   Stop taking this medication and tell your doctor right away if||
6309|115|S|this very serious side effect occurs: lactic acidosis (see||
6309|116|S|Warning section).||
6309|117|S|   A very serious allergic reaction to this drug is rare.||
6309|118|S|However, get medical help right away if you notice any symptoms||
6309|119|S|of a serious allergic reaction, including: rash, itching/swelling||
6309|120|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6309|121|S|breathing.||
6309|122|S|   This is not a complete list of possible side effects. If you||
6309|123|S|notice other effects not listed above, contact your doctor or||
6309|124|S|pharmacist.||
6309|125|S|   In the US -||
6309|126|S|   Call your doctor for medical advice about side effects. You||
6309|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6309|128|S|www.fda.gov/medwatch.||
6309|129|S|   In Canada - Call your doctor for medical advice about side||
6309|130|S|effects. You may report side effects to Health Canada at||
6309|131|S|1-866-234-2345.||
6309|132|B|||
6309|133|P|PRECAUTIONS:  See also Warning section.||
6309|134|P|   Before taking this medication, tell your doctor or pharmacist||
6309|135|P|if you are allergic to metformin; or if you have any other||
6309|136|P|allergies. This product may contain inactive ingredients, which||
6309|137|P|can cause allergic reactions or other problems. Talk to your||
6309|138|P|pharmacist for more details.||
6309|139|P|   Before using this medication, tell your doctor or pharmacist||
6309|140|P|your medical history, especially of: severe breathing problems||
6309|141|P|(such as obstructive lung disease, severe asthma), blood problems||
6309|142|P|(such as anemia, vitamin B12 deficiency), kidney disease, liver||
6309|143|P|disease.||
6309|144|P|   Before having surgery or any X-ray/scanning procedure using||
6309|145|P|iodinated contrast, tell your doctor or dentist about all the||
6309|146|P|products you use (including prescription drugs, nonprescription||
6309|147|P|drugs, and herbal products). You may need to stop this medication||
6309|148|P|for a short time for the surgery/procedure. Ask your doctor or||
6309|149|P|dentist for instructions before your surgery/procedure.||
6309|150|P|   You may experience blurred vision, dizziness, or drowsiness||
6309|151|P|due to extremely low or high blood sugar. Do not drive, use||
6309|152|P|machinery, or do anything that needs alertness or clear vision||
6309|153|P|until you can do it safely.||
6309|154|P|   Limit alcohol while using this medication because it can||
6309|155|P|increase your risk of lactic acidosis and developing low blood||
6309|156|P|sugar.||
6309|157|P|   High fever, "water pills" (diuretics such as||
6309|158|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
6309|159|P|may cause dehydration and increase your risk of lactic acidosis.||
6309|160|P|Stop taking this medication and tell your doctor right away if||
6309|161|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
6309|162|P|fluids to prevent dehydration unless your doctor directs you||
6309|163|P|otherwise.||
6309|164|P|   It may be harder to control your blood sugar when your body is||
6309|165|P|stressed (such as due to fever, infection, injury, or surgery).||
6309|166|P|Consult your doctor because increased stress may require a change||
6309|167|P|in your treatment plan, medications, or blood sugar testing.||
6309|168|P|   Older adults may be a greater risk for side effects such as||
6309|169|P|low blood sugar or lactic acidosis.||
6309|170|P|   During pregnancy, this medication should be used only when||
6309|171|P|clearly needed. Discuss the risks and benefits with your doctor.||
6309|172|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
6309|173|P|your doctor for managing your blood sugar while pregnant. Your||
6309|174|P|doctor may change your diabetes treatment during your pregnancy||
6309|175|P|(such as diet and medications including insulin).||
6309|176|P|   Metformin can cause changes in the menstrual cycle (promote||
6309|177|P|ovulation) and increase the risk of becoming pregnant. Consult||
6309|178|P|your doctor or pharmacist about the use of reliable birth control||
6309|179|P|while using this medication.||
6309|180|P|   Metformin passes into breast milk in small amounts. Consult||
6309|181|P|your doctor before breastfeeding.||
6309|182|B|||
6309|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6309|184|I|medications work or increase your risk for serious side effects.||
6309|185|I|This document does not contain all possible drug interactions.||
6309|186|I|Keep a list of all the products you use (including||
6309|187|I|prescription/nonprescription drugs and herbal products) and share||
6309|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
6309|189|I|the dosage of any medicines without your doctor's approval.||
6309|190|I|   Beta-blocker medications (such as metoprolol, propranolol,||
6309|191|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
6309|192|I|heartbeat you would usually feel when your blood sugar falls too||
6309|193|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
6309|194|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
6309|195|I|   Many drugs can affect your blood sugar, making it harder to||
6309|196|I|control. Before you start, stop, or change any medication, talk||
6309|197|I|with your doctor or pharmacist about how the medication may||
6309|198|I|affect your blood sugar. Check your blood sugar regularly as||
6309|199|I|directed and share the results with your doctor. Tell your doctor||
6309|200|I|right away if you have symptoms of high or low blood sugar. (See||
6309|201|I|also Side Effects section.) Your doctor may need to adjust your||
6309|202|I|diabetes medication, exercise program, or diet.||
6309|203|B|||
6309|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6309|205|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6309|206|O|poison control center right away. US residents can call||
6309|207|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6309|208|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
6309|209|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
6309|210|O|rapid breathing, slow/irregular heartbeat.||
6309|211|B|||
6309|212|N|NOTES:  Do not share this medication with others.||
6309|213|N|   Attend a diabetes education program to learn more about how to||
6309|214|N|manage your diabetes with medications, diet, exercise, and||
6309|215|N|regular medical exams.||
6309|216|N|   Learn the symptoms of high and low blood sugar and how to||
6309|217|N|treat low blood sugar. Check your blood sugar regularly as||
6309|218|N|directed and share the results with your doctor.||
6309|219|N|   Lab and/or medical tests (such as kidney function, liver||
6309|220|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
6309|221|N|should be done before you start taking this medication and while||
6309|222|N|you are taking it. Keep all medical and lab appointments. Consult||
6309|223|N|your doctor for more details.||
6309|224|B|||
6309|225|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6309|226|D|remember. If it is near the time of the next dose, skip the||
6309|227|D|missed dose. Take your next dose at the regular time. Do not||
6309|228|D|double the dose to catch up.||
6309|229|B|||
6309|230|R|STORAGE:  Store at room temperature away from light and moisture.||
6309|231|R|Do not store in the bathroom. Keep all medications away from||
6309|232|R|children and pets.||
6309|233|R|   Do not flush medications down the toilet or pour them into a||
6309|234|R|drain unless instructed to do so. Properly discard this product||
6309|235|R|when it is expired or no longer needed. Consult your pharmacist||
6309|236|R|or local waste disposal company.||
6309|237|B|||
6309|238|M|MEDICAL ALERT:  Your condition can cause complications in a||
6309|239|M|medical emergency. For information about enrolling in MedicAlert,||
6309|240|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6309|241|B|||
6309|242|A|Information last revised November 2025.||
6309|243|A|Copyright(c) 2025 First Databank, Inc.||
6309|244|B|||
6311|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6311|002|Z|does NOT have all possible information about this product. This||
6311|003|Z|information does not assure that this product is safe, effective,||
6311|004|Z|or appropriate for you. This information is not individual||
6311|005|Z|medical advice and does not substitute for the advice of your||
6311|006|Z|health care professional. Always ask your health care||
6311|007|Z|professional for complete information about this product and your||
6311|008|Z|specific health needs.||
6311|009|B|||
6311|010|T|VALERIAN (Valeriana officinalis) - ORAL||
6311|011|B|||
6311|012|U|USES:  Valerian root has been used for sleep problems (insomnia).||
6311|013|U|   Some herbal/dietary supplement products have been found to||
6311|014|U|contain possibly harmful impurities/additives. Check with your||
6311|015|U|pharmacist for more details about the brand you use.||
6311|016|U|   The FDA has not reviewed this product for safety or||
6311|017|U|effectiveness. Consult your doctor or pharmacist for more||
6311|018|U|details.||
6311|019|B|||
6311|020|H|HOW TO USE:  Take this product by mouth, usually 30 minutes to 2||
6311|021|H|hours before bedtime or as directed. Follow all directions on the||
6311|022|H|product package. If you have any questions, ask your doctor or||
6311|023|H|pharmacist.||
6311|024|H|   This herbal product should not be used for more than 4 weeks.||
6311|025|H|To reduce the chance of possible side effects when stopping||
6311|026|H|extended use of valerian, do not suddenly stop taking it. Your||
6311|027|H|dose may need to be gradually decreased over 1 to 2 weeks before||
6311|028|H|stopping completely. Consult your doctor or pharmacist for more||
6311|029|H|details.||
6311|030|H|   If your condition lasts or gets worse, or if you think you may||
6311|031|H|have a serious medical problem, get medical help right away.||
6311|032|B|||
6311|033|S|SIDE EFFECTS:  Headache, restlessness, upset stomach, or||
6311|034|S|drowsiness/tiredness after waking up may occur. If any of these||
6311|035|S|effects last or get worse, tell your doctor or pharmacist||
6311|036|S|promptly.||
6311|037|S|   Tell your doctor right away if you have any serious side||
6311|038|S|effects, including: nausea/vomiting that doesn't stop,||
6311|039|S|stomach/abdominal pain, yellowing eyes/skin, dark urine, extreme||
6311|040|S|tiredness.||
6311|041|S|   A very serious allergic reaction to this product is rare.||
6311|042|S|However, get medical help right away if you notice any symptoms||
6311|043|S|of a serious allergic reaction, including: rash, itching/swelling||
6311|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6311|045|S|breathing.||
6311|046|S|   This is not a complete list of possible side effects. If you||
6311|047|S|notice other effects not listed above, contact your doctor or||
6311|048|S|pharmacist.||
6311|049|S|   In the US -||
6311|050|S|   Call your doctor for medical advice about side effects. You||
6311|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6311|052|S|www.fda.gov/medwatch.||
6311|053|S|   In Canada - Call your doctor for medical advice about side||
6311|054|S|effects. You may report side effects to Health Canada at||
6311|055|S|1-866-234-2345.||
6311|056|B|||
6311|057|P|PRECAUTIONS:  Before taking valerian, tell your doctor or||
6311|058|P|pharmacist if you are allergic to it; or if you have any other||
6311|059|P|allergies. This product may contain inactive ingredients, which||
6311|060|P|can cause allergic reactions or other problems. Talk to your||
6311|061|P|pharmacist for more details.||
6311|062|P|   If you have any of the following health problems, consult your||
6311|063|P|doctor or pharmacist before using this product: liver problems.||
6311|064|P|   Liquid forms of this product may contain sugar and/or alcohol.||
6311|065|P|Caution is advised if you have diabetes, alcohol dependence, or||
6311|066|P|liver disease. Ask your doctor or pharmacist about using this||
6311|067|P|product safely.||
6311|068|P|   This product may make you drowsy. Alcohol or marijuana||
6311|069|P|(cannabis) can make you more drowsy. Do not drive, use machinery,||
6311|070|P|or do anything that needs alertness until you can do it safely.||
6311|071|P|Avoid alcoholic beverages. Talk to your doctor if you are using||
6311|072|P|marijuana (cannabis).||
6311|073|P|   This product is not recommended for use during pregnancy.||
6311|074|P|Consult your doctor before using this product.||
6311|075|P|   It is unknown if this product passes into breast milk. Consult||
6311|076|P|your doctor before breastfeeding.||
6311|077|B|||
6311|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6311|079|I|medications work or increase your risk for serious side effects.||
6311|080|I|This document does not contain all possible drug interactions.||
6311|081|I|Keep a list of all the products you use (including||
6311|082|I|prescription/nonprescription drugs and herbal products) and share||
6311|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
6311|084|I|the dosage of any medicines without your doctor's approval.||
6311|085|I|   Tell your doctor or pharmacist if you are taking other||
6311|086|I|products that cause drowsiness such as opioid pain or cough||
6311|087|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6311|088|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
6311|089|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6311|090|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6311|091|I|diphenhydramine).||
6311|092|I|   Check the labels on all your medicines (such as allergy or||
6311|093|I|cough-and-cold products) because they may contain ingredients||
6311|094|I|that cause drowsiness. Ask your pharmacist about using those||
6311|095|I|products safely.||
6311|096|B|||
6311|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6311|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6311|099|O|poison control center right away. US residents can call||
6311|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6311|101|O|Symptoms of overdose may include: unusual tiredness, stomach||
6311|102|O|cramping, chest tightness, shaking of hands/feet.||
6311|103|B|||
6311|104|N|NOTES:  With long-term use, lab and/or medical tests (such as||
6311|105|N|liver function) should be done while you are taking this product.||
6311|106|N|Keep all medical and lab appointments. Consult your doctor for||
6311|107|N|more details.||
6311|108|B|||
6311|109|D|MISSED DOSE:  Not applicable.||
6311|110|B|||
6311|111|R|STORAGE:  Refer to storage information printed on the package. If||
6311|112|R|you have any questions about storage, ask your pharmacist. Keep||
6311|113|R|all medications and herbal products away from children and pets.||
6311|114|R|   Do not flush medications down the toilet or pour them into a||
6311|115|R|drain unless instructed to do so. Properly discard this product||
6311|116|R|when it is expired or no longer needed. Consult your pharmacist||
6311|117|R|or local waste disposal company.||
6311|118|B|||
6311|119|A|Information last revised May 2024.||
6311|120|A|Copyright(c) 2025 First Databank, Inc.||
6311|121|B|||
6313|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6313|002|Z|does NOT have all possible information about this product. This||
6313|003|Z|information does not assure that this product is safe, effective,||
6313|004|Z|or appropriate for you. This information is not individual||
6313|005|Z|medical advice and does not substitute for the advice of your||
6313|006|Z|health care professional. Always ask your health care||
6313|007|Z|professional for complete information about this product and your||
6313|008|Z|specific health needs.||
6313|009|B|||
6313|010|T|MILK THISTLE (Silybum marianum) - ORAL||
6313|011|B|||
6313|012|U|USES:  Milk thistle has been used for diabetes in combination||
6313|013|U|with standard treatment. It has also been used for liver disease||
6313|014|U|although it has not been shown to be effective. Consult your||
6313|015|U|doctor for more information if you have either of these serious||
6313|016|U|conditions.||
6313|017|U|   Some herbal/dietary supplement products have been found to||
6313|018|U|contain possibly harmful impurities/additives. Check with your||
6313|019|U|pharmacist for more details about the brand you use.||
6313|020|U|   The FDA has not reviewed this product for safety or||
6313|021|U|effectiveness. Consult your doctor or pharmacist for more||
6313|022|U|details.||
6313|023|B|||
6313|024|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
6313|025|H|directions on the product package. If you have any questions, ask||
6313|026|H|your doctor or pharmacist.||
6313|027|H|   If your condition lasts or gets worse, or if you think you may||
6313|028|H|have a serious medical problem, get medical help right away.||
6313|029|B|||
6313|030|S|SIDE EFFECTS:  Loose stools or upset stomach may occur. If any of||
6313|031|S|these effects last or get worse, tell your doctor or pharmacist||
6313|032|S|promptly.||
6313|033|S|   A very serious allergic reaction to this product is rare.||
6313|034|S|However, get medical help right away if you notice any symptoms||
6313|035|S|of a serious allergic reaction, including: rash, itching/swelling||
6313|036|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6313|037|S|breathing.||
6313|038|S|   This is not a complete list of possible side effects. If you||
6313|039|S|notice other effects not listed above, contact your doctor or||
6313|040|S|pharmacist.||
6313|041|S|   In the US -||
6313|042|S|   Call your doctor for medical advice about side effects. You||
6313|043|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6313|044|S|www.fda.gov/medwatch.||
6313|045|S|   In Canada - Call your doctor for medical advice about side||
6313|046|S|effects. You may report side effects to Health Canada at||
6313|047|S|1-866-234-2345.||
6313|048|B|||
6313|049|P|PRECAUTIONS:  Before taking milk thistle, tell your doctor or||
6313|050|P|pharmacist if you are allergic to it; or to ragweed,||
6313|051|P|chrysanthemums, marigolds, or daisies; or if you have any other||
6313|052|P|allergies. This product may contain inactive ingredients, which||
6313|053|P|can cause allergic reactions or other problems. Talk to your||
6313|054|P|pharmacist for more details.||
6313|055|P|   If you have any of the following health problems, consult your||
6313|056|P|doctor or pharmacist before using this product: conditions that||
6313|057|P|are affected by estrogen (such as endometriosis, uterine||
6313|058|P|fibroids, cancer of the breast/uterus/ovary).||
6313|059|P|   Liquid forms of this product may contain sugar and/or alcohol.||
6313|060|P|These ingredients may affect conditions such as diabetes, alcohol||
6313|061|P|dependence, or liver disease. Ask your doctor or pharmacist about||
6313|062|P|using this product safely.||
6313|063|P|   This product is not recommended for use during pregnancy.||
6313|064|P|Consult your doctor before using this product.||
6313|065|P|   It is unknown if this product passes into breast milk. Consult||
6313|066|P|your doctor before breastfeeding.||
6313|067|B|||
6313|068|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6313|069|I|medications work or increase your risk for serious side effects.||
6313|070|I|This document does not contain all possible drug interactions.||
6313|071|I|Keep a list of all the products you use (including||
6313|072|I|prescription/nonprescription drugs and herbal products) and share||
6313|073|I|it with your doctor and pharmacist. Do not start, stop, or change||
6313|074|I|the dosage of any medicines without your doctor's approval.||
6313|075|B|||
6313|076|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6313|077|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6313|078|O|poison control center right away. US residents can call||
6313|079|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6313|080|B|||
6313|081|N|NOTES:  Keep all medical and lab appointments.||
6313|082|B|||
6313|083|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6313|084|D|remember. If it is near the time of the next dose, skip the||
6313|085|D|missed dose. Take your next dose at the regular time. Do not||
6313|086|D|double the dose to catch up.||
6313|087|B|||
6313|088|R|STORAGE:  Refer to storage information printed on the package. If||
6313|089|R|you have any questions about storage, ask your pharmacist. Keep||
6313|090|R|all medications and herbal products away from children and pets.||
6313|091|R|   Do not flush medications down the toilet or pour them into a||
6313|092|R|drain unless instructed to do so. Properly discard this product||
6313|093|R|when it is expired or no longer needed. Consult your pharmacist||
6313|094|R|or local waste disposal company.||
6313|095|B|||
6313|096|A|Information last revised May 2024.||
6313|097|A|Copyright(c) 2025 First Databank, Inc.||
6313|098|B|||
6317|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6317|002|Z|does NOT have all possible information about this product. This||
6317|003|Z|information does not assure that this product is safe, effective,||
6317|004|Z|or appropriate for you. This information is not individual||
6317|005|Z|medical advice and does not substitute for the advice of your||
6317|006|Z|health care professional. Always ask your health care||
6317|007|Z|professional for complete information about this product and your||
6317|008|Z|specific health needs.||
6317|009|B|||
6317|010|T|MOXIFLOXACIN - INJECTION||
6317|011|F|(mox-i-FLOX-a-sin)||
6317|012|B|||
6317|013|C|COMMON BRAND NAME(S): Avelox||
6317|014|B|||
6317|015|W|WARNING:  Quinolone antibiotics (including moxifloxacin) may||
6317|016|W|cause serious and possibly permanent tendon damage (such as||
6317|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
6317|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
6317|019|W|help right away if you have any of the following symptoms:||
6317|020|W|pain/numbness/burning/tingling/weakness in your||
6317|021|W|arms/hands/legs/feet, changes in how you sense||
6317|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
6317|023|W|headache, vision changes, shaking (tremors), seizures,||
6317|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
6317|025|W|hallucinations, depression, rare thoughts of suicide).||
6317|026|W|   Tendon damage may occur during or after treatment with this||
6317|027|W|medication. Stop exercising, rest, and get medical help right||
6317|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
6317|029|W|risk for tendon problems is greater if you are over 60 years of||
6317|030|W|age, if you are taking corticosteroids (such as prednisone), or||
6317|031|W|if you have a kidney, heart, or lung transplant.||
6317|032|W|   This medication may make a certain muscle condition||
6317|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
6317|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
6317|035|W|unsteady walk) or trouble breathing.||
6317|036|W|   Discuss the risks and benefits with your doctor before using||
6317|037|W|this medication.||
6317|038|B|||
6317|039|U|USES:  This medication is used to treat a variety of bacterial||
6317|040|U|infections. Moxifloxacin belongs to a class of drugs called||
6317|041|U|quinolone antibiotics. It works by stopping the growth of||
6317|042|U|bacteria. Moxifloxacin injection is used when you cannot take the||
6317|043|U|medication by mouth.||
6317|044|B|||
6317|045|H|HOW TO USE:  Read the Medication Guide and, if available, the||
6317|046|H|Patient Information Leaflet provided by your pharmacist before||
6317|047|H|you start using moxifloxacin and each time you get a refill. If||
6317|048|H|you have any questions, ask your doctor or pharmacist.||
6317|049|H|   This medication is given by injection into a vein as directed||
6317|050|H|by your doctor, usually once daily. Do not inject into the skin||
6317|051|H|or muscle. Give this medication over at least 60 minutes. Your||
6317|052|H|heartbeat may increase if the medication is given too fast. If||
6317|053|H|you feel dizzy, tell your health care professional right away.||
6317|054|H|   The dosage and length of treatment are based on your condition||
6317|055|H|and response to treatment. As soon as you are able to take||
6317|056|H|medications by mouth, your doctor will switch you to an||
6317|057|H|antibiotic that is taken by mouth.||
6317|058|H|   If you are using this medication at home, learn all||
6317|059|H|preparation and usage instructions from your health care||
6317|060|H|professional. Before using, check this product for particles or||
6317|061|H|discoloration. If either is present, do not use the liquid. Learn||
6317|062|H|how to store and discard medical supplies safely.||
6317|063|H|   Drink plenty of fluids while using this medication unless your||
6317|064|H|doctor directs you otherwise. If you are unable to take fluids by||
6317|065|H|mouth, you will be given fluids through a vein.||
6317|066|H|   For the best effect, use this antibiotic at evenly spaced||
6317|067|H|times. To help you remember, use this medication at the same||
6317|068|H|time(s) every day.||
6317|069|H|   Continue to use this medication until the full prescribed||
6317|070|H|amount is finished, even if symptoms disappear after a few days.||
6317|071|H|Stopping the medication too early may result in a return of the||
6317|072|H|infection.||
6317|073|H|   Tell your doctor if your condition lasts or gets worse.||
6317|074|B|||
6317|075|S|SIDE EFFECTS:  See also Warning section.||
6317|076|S|   Pain/redness/swelling at the injection site, nausea, diarrhea,||
6317|077|S|headache, weakness, dizziness, lightheadedness, or trouble||
6317|078|S|sleeping may occur. If any of these effects last or get worse,||
6317|079|S|tell your doctor or pharmacist promptly.||
6317|080|S|   Remember that this medication has been prescribed because your||
6317|081|S|doctor has judged that the benefit to you is greater than the||
6317|082|S|risk of side effects. Many people using this medication do not||
6317|083|S|have serious side effects.||
6317|084|S|   Tell your doctor right away if you have any serious side||
6317|085|S|effects, including: unusual bruising/bleeding, signs of a new||
6317|086|S|infection (such as sore throat that doesn't go away, fever),||
6317|087|S|signs of kidney problems (such as change in the amount of urine),||
6317|088|S|signs of liver problems (such as nausea/vomiting that doesn't||
6317|089|S|stop, unusual tiredness, stomach/abdominal pain, yellowing||
6317|090|S|eyes/skin, dark urine).||
6317|091|S|   Get medical help right away if you have any very serious side||
6317|092|S|effects, including: severe dizziness, fainting, fast/irregular||
6317|093|S|heartbeat, signs of a tear/break in the main blood vessel called||
6317|094|S|the aorta (such as sudden/severe pain in the stomach/chest/back,||
6317|095|S|shortness of breath).||
6317|096|S|   Use of this medication for prolonged or repeated periods may||
6317|097|S|result in oral thrush or a new vaginal yeast infection. Contact||
6317|098|S|your doctor if you notice white patches in your mouth, a change||
6317|099|S|in vaginal discharge, or other new symptoms.||
6317|100|S|   This medication may rarely cause a severe intestinal condition||
6317|101|S|due to a bacteria called C. difficile. This condition may occur||
6317|102|S|during treatment or weeks to months after treatment has stopped.||
6317|103|S|Tell your doctor right away if you develop: diarrhea that doesn't||
6317|104|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
6317|105|S|stool.||
6317|106|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
6317|107|S|products because they may make symptoms worse.||
6317|108|S|   A very serious allergic reaction to this drug is rare.||
6317|109|S|However, get medical help right away if you notice any symptoms||
6317|110|S|of a serious allergic reaction, including: rash, itching/swelling||
6317|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6317|112|S|breathing.||
6317|113|S|   This is not a complete list of possible side effects. If you||
6317|114|S|notice other effects not listed above, contact your doctor or||
6317|115|S|pharmacist.||
6317|116|S|   In the US -||
6317|117|S|   Call your doctor for medical advice about side effects. You||
6317|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6317|119|S|www.fda.gov/medwatch.||
6317|120|S|   In Canada - Call your doctor for medical advice about side||
6317|121|S|effects. You may report side effects to Health Canada at||
6317|122|S|1-866-234-2345.||
6317|123|B|||
6317|124|P|PRECAUTIONS:  See also Warning section.||
6317|125|P|   Before using moxifloxacin, tell your doctor or pharmacist if||
6317|126|P|you are allergic to it; or to other quinolone antibiotics (such||
6317|127|P|as ciprofloxacin, levofloxacin); or if you have any other||
6317|128|P|allergies. This product may contain inactive ingredients, which||
6317|129|P|can cause allergic reactions or other problems. Talk to your||
6317|130|P|pharmacist for more details.||
6317|131|P|   Before using this medication, tell your doctor or pharmacist||
6317|132|P|your medical history, especially of: diabetes, heart problems||
6317|133|P|(such as recent heart attack), joint/tendon problems (such as||
6317|134|P|tendonitis, bursitis), liver disease, mental/mood disorders (such||
6317|135|P|as depression), myasthenia gravis, nerve problems (such as||
6317|136|P|peripheral neuropathy), seizure disorder, conditions that||
6317|137|P|increase your risk of seizures (such as brain/head injury, brain||
6317|138|P|tumors, cerebral atherosclerosis), blood vessel problems (such as||
6317|139|P|aneurysm or blockage of the aorta or other blood vessels,||
6317|140|P|hardening of the arteries), high blood pressure, certain genetic||
6317|141|P|conditions (Marfan syndrome, Ehlers-Danlos syndrome).||
6317|142|P|   Moxifloxacin may cause a condition that affects the heart||
6317|143|P|rhythm (QT prolongation). QT prolongation can rarely cause||
6317|144|P|serious (rarely fatal) fast/irregular heartbeat and other||
6317|145|P|symptoms (such as severe dizziness, fainting) that need medical||
6317|146|P|attention right away.||
6317|147|P|   The risk of QT prolongation may be increased if you have||
6317|148|P|certain medical conditions or are taking other drugs that may||
6317|149|P|cause QT prolongation. Before using moxifloxacin, tell your||
6317|150|P|doctor or pharmacist of all the drugs you take and if you have||
6317|151|P|any of the following conditions: certain heart problems (heart||
6317|152|P|failure, slow heartbeat, QT prolongation in the EKG), family||
6317|153|P|history of certain heart problems (QT prolongation in the EKG,||
6317|154|P|sudden cardiac death).||
6317|155|P|   Low levels of potassium or magnesium in the blood may also||
6317|156|P|increase your risk of QT prolongation. This risk may increase if||
6317|157|P|you use certain drugs (such as diuretics/"water pills") or if you||
6317|158|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6317|159|P|Talk to your doctor about using moxifloxacin safely.||
6317|160|P|   This medication may rarely cause serious changes in blood||
6317|161|P|sugar, especially if you have diabetes. Check your blood sugar||
6317|162|P|regularly as directed and share the results with your doctor.||
6317|163|P|Watch for symptoms of high blood sugar, such as increased||
6317|164|P|thirst/urination. Also watch for symptoms of low blood sugar such||
6317|165|P|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
6317|166|P|vision, dizziness, or tingling hands/feet. It is a good habit to||
6317|167|P|carry glucose tablets or gel to treat low blood sugar. If you||
6317|168|P|don't have these reliable forms of glucose, rapidly raise your||
6317|169|P|blood sugar by eating a quick source of sugar such as table||
6317|170|P|sugar, honey, or candy, or by drinking fruit juice or non-diet||
6317|171|P|soda. Tell your doctor right away about the reaction and the use||
6317|172|P|of this product. To help prevent low blood sugar, eat meals on a||
6317|173|P|regular schedule, and do not skip meals. Your doctor may need to||
6317|174|P|switch you to another antibiotic or adjust your diabetes||
6317|175|P|medications if any reaction occurs.||
6317|176|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6317|177|P|can make you more dizzy. Do not drive, use machinery, or do||
6317|178|P|anything that needs alertness until you can do it safely. Limit||
6317|179|P|alcoholic beverages. Talk to your doctor if you are using||
6317|180|P|marijuana (cannabis).||
6317|181|P|   This medication may make you more sensitive to the sun. Limit||
6317|182|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
6317|183|P|sunscreen and wear protective clothing when outdoors. Tell your||
6317|184|P|doctor right away if you get sunburned or have skin||
6317|185|P|blisters/redness.||
6317|186|P|   Moxifloxacin may cause live bacterial vaccines (such as||
6317|187|P|typhoid vaccine) to not work well. Tell your health care||
6317|188|P|professional that you are using moxifloxacin before having any||
6317|189|P|immunizations/vaccinations.||
6317|190|P|   Before having surgery, tell your doctor or dentist about all||
6317|191|P|the products you use (including prescription drugs,||
6317|192|P|nonprescription drugs, and herbal products).||
6317|193|P|   Children may be more sensitive to the side effects of this||
6317|194|P|drug, especially joint/tendon problems.||
6317|195|P|   Older adults may be at greater risk for tendon problems||
6317|196|P|(especially if they are also taking corticosteroids such as||
6317|197|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
6317|198|P|tear/break in the main blood vessel (aorta).||
6317|199|P|   During pregnancy, this medication should be used only when||
6317|200|P|clearly needed. Discuss the risks and benefits with your doctor.||
6317|201|P|   It is unknown if this drug passes into breast milk. Consult||
6317|202|P|your doctor before breastfeeding.||
6317|203|B|||
6317|204|I|DRUG INTERACTIONS:  See also Warning and Precautions sections.||
6317|205|I|   Drug interactions may change how your medications work or||
6317|206|I|increase your risk for serious side effects. This document does||
6317|207|I|not contain all possible drug interactions. Keep a list of all||
6317|208|I|the products you use (including prescription/nonprescription||
6317|209|I|drugs and herbal products) and share it with your doctor and||
6317|210|I|pharmacist. Do not start, stop, or change the dosage of any||
6317|211|I|medicines without your doctor's approval.||
6317|212|I|   Some products that may interact with this drug include: "blood||
6317|213|I|thinners" (such as acenocoumarol, warfarin), strontium.||
6317|214|I|   Many drugs besides moxifloxacin may affect the heart rhythm||
6317|215|I|(QT prolongation), including amiodarone, dofetilide,||
6317|216|I|procainamide, quinidine, sotalol, ziprasidone, among others.||
6317|217|B|||
6317|218|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6317|219|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6317|220|O|poison control center right away. US residents can call||
6317|221|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6317|222|B|||
6317|223|N|NOTES:  Lab and/or medical tests (such as liver function,||
6317|224|N|complete blood count, blood glucose) should be done while you are||
6317|225|N|using this medication. Keep all medical and lab appointments.||
6317|226|N|Consult your doctor for more details.||
6317|227|B|||
6317|228|D|MISSED DOSE:  It is important to get each dose of this medication||
6317|229|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6317|230|D|right away for a new dosing schedule.||
6317|231|B|||
6317|232|R|STORAGE:  Consult the product instructions and your pharmacist||
6317|233|R|for storage details. Keep all medications away from children and||
6317|234|R|pets.||
6317|235|R|   Do not flush medications down the toilet or pour them into a||
6317|236|R|drain unless instructed to do so. Properly discard this product||
6317|237|R|when it is expired or no longer needed. Consult your pharmacist||
6317|238|R|or local waste disposal company.||
6317|239|B|||
6317|240|A|Information last revised November 2024.||
6317|241|A|Copyright(c) 2025 First Databank, Inc.||
6317|242|B|||
6324|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6324|002|Z|does NOT have all possible information about this product. This||
6324|003|Z|information does not assure that this product is safe, effective,||
6324|004|Z|or appropriate for you. This information is not individual||
6324|005|Z|medical advice and does not substitute for the advice of your||
6324|006|Z|health care professional. Always ask your health care||
6324|007|Z|professional for complete information about this product and your||
6324|008|Z|specific health needs.||
6324|009|B|||
6324|010|T|CETIRIZINE/PSEUDOEPHEDRINE EXTENDED-RELEASE - ORAL||
6324|011|F|(se-TIR-i-zeen/SOO-doe-e-FED-rin)||
6324|012|B|||
6324|013|C|COMMON BRAND NAME(S): Zyrtec-D||
6324|014|B|||
6324|015|U|USES:  This medication is used to relieve allergy symptoms such||
6324|016|U|as watery eyes, runny/stuffy nose, itching eyes/nose, and||
6324|017|U|sneezing. It contains 2 medications: cetirizine and||
6324|018|U|pseudoephedrine. Cetirizine is an antihistamine and works by||
6324|019|U|blocking a certain natural substance (histamine) that your body||
6324|020|U|makes during an allergic reaction. Pseudoephedrine is a||
6324|021|U|decongestant and works by narrowing the blood vessels in the nose||
6324|022|U|to decrease swelling and congestion.||
6324|023|U|   This medication is not recommended for use in children under||
6324|024|U|12 years of age due to the large amount of pseudoephedrine in it.||
6324|025|B|||
6324|026|H|HOW TO USE:  If you are taking the over-the-counter product to||
6324|027|H|self-treat, read all directions on the product package before||
6324|028|H|taking this medication. If you have any questions, consult your||
6324|029|H|pharmacist. If your doctor has prescribed this medication, take||
6324|030|H|it as directed with or without food, usually twice daily (every||
6324|031|H|12 hours).||
6324|032|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
6324|033|H|Doing so can release all of the drug at once, increasing the risk||
6324|034|H|of side effects.||
6324|035|H|   The dosage is based on your age, medical condition, and||
6324|036|H|response to treatment. Do not increase your dose or take this||
6324|037|H|medication more often than directed.||
6324|038|H|   Tell your doctor if your symptoms do not get better after 1||
6324|039|H|week, if they get worse, or if they occur with a fever.||
6324|040|B|||
6324|041|S|SIDE EFFECTS:  Drowsiness, dizziness, tiredness, dry mouth,||
6324|042|S|nausea, headache, or trouble sleeping may occur. If any of these||
6324|043|S|effects last or get worse, tell your doctor or pharmacist||
6324|044|S|promptly.||
6324|045|S|   If your doctor has prescribed this medication, remember that||
6324|046|S|your doctor has judged that the benefit to you is greater than||
6324|047|S|the risk of side effects. Many people using this medication do||
6324|048|S|not have serious side effects.||
6324|049|S|   This medication may raise your blood pressure. Check your||
6324|050|S|blood pressure regularly and tell your doctor if the results are||
6324|051|S|high.||
6324|052|S|   Tell your doctor right away if you have any serious side||
6324|053|S|effects, including: difficulty urinating, fast/irregular/pounding||
6324|054|S|heartbeat, shaking (tremor), mental/mood changes (such as||
6324|055|S|anxiety, confusion, nervousness, restlessness), weakness.||
6324|056|S|   Get medical help right away if you have any very serious side||
6324|057|S|effects, including: seizures.||
6324|058|S|   Rarely, severe itching may occur after stopping the long-term||
6324|059|S|use of cetirizine (taking the medication for a few months to||
6324|060|S|years). Talk to your doctor about the risks and benefits of this||
6324|061|S|medication, especially if you are using cetirizine regularly for||
6324|062|S|a long time. Tell your doctor right away if itching occurs after||
6324|063|S|stopping the medication.||
6324|064|S|   A very serious allergic reaction to this drug is rare.||
6324|065|S|However, get medical help right away if you notice any symptoms||
6324|066|S|of a serious allergic reaction, including: rash, itching/swelling||
6324|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6324|068|S|breathing.||
6324|069|S|   This is not a complete list of possible side effects. If you||
6324|070|S|notice other effects not listed above, contact your doctor or||
6324|071|S|pharmacist.||
6324|072|S|   In the US -||
6324|073|S|   Call your doctor for medical advice about side effects. You||
6324|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6324|075|S|www.fda.gov/medwatch.||
6324|076|S|   In Canada - Call your doctor for medical advice about side||
6324|077|S|effects. You may report side effects to Health Canada at||
6324|078|S|1-866-234-2345.||
6324|079|B|||
6324|080|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
6324|081|P|pharmacist if you are allergic to cetirizine or pseudoephedrine;||
6324|082|P|or to hydroxyzine; or to levocetirizine; or if you have any other||
6324|083|P|allergies. Also, tell your doctor if you have had serious side||
6324|084|P|effects from similar medications (such as other decongestants,||
6324|085|P|including phenylephrine). This product may contain inactive||
6324|086|P|ingredients, which can cause allergic reactions or other||
6324|087|P|problems. Talk to your pharmacist for more details.||
6324|088|P|   Before using this medication, tell your doctor or pharmacist||
6324|089|P|your medical history, especially of: glaucoma, difficulty||
6324|090|P|urinating (such as due to an enlarged prostate), high blood||
6324|091|P|pressure (hypertension), heart/blood vessel disease (such as||
6324|092|P|coronary artery disease), overactive thyroid (hyperthyroidism),||
6324|093|P|diabetes, kidney disease, liver disease.||
6324|094|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6324|095|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6324|096|P|machinery, or do anything that needs alertness until you can do||
6324|097|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6324|098|P|are using marijuana (cannabis).||
6324|099|P|   Before having surgery, tell your doctor or dentist about all||
6324|100|P|the products you use (including prescription drugs,||
6324|101|P|nonprescription drugs, and herbal products).||
6324|102|P|   Older adults may be more sensitive to the side effects of this||
6324|103|P|drug, especially fast/irregular heartbeat, dizziness, problems||
6324|104|P|urinating, trouble sleeping, or confusion.||
6324|105|P|   During pregnancy, this medication should be used only when||
6324|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
6324|107|P|   This medication passes into breast milk. Consult your doctor||
6324|108|P|before breastfeeding.||
6324|109|B|||
6324|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6324|111|I|medications work or increase your risk for serious side effects.||
6324|112|I|This document does not contain all possible drug interactions.||
6324|113|I|Keep a list of all the products you use (including||
6324|114|I|prescription/nonprescription drugs and herbal products) and share||
6324|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
6324|116|I|the dosage of any medicines without your doctor's approval.||
6324|117|I|   Taking MAO inhibitors with this medication may cause a serious||
6324|118|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
6324|119|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
6324|120|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
6324|121|I|selegiline, tranylcypromine) during treatment with this||
6324|122|I|medication. Most MAO inhibitors should also not be taken for two||
6324|123|I|weeks before treatment with this medication. Ask your doctor when||
6324|124|I|to start or stop taking this medication.||
6324|125|I|   Tell your doctor or pharmacist if you are taking other||
6324|126|I|products that cause drowsiness such as opioid pain or cough||
6324|127|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6324|128|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
6324|129|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6324|130|I|cyclobenzaprine), or other antihistamines (such as||
6324|131|I|chlorpheniramine, diphenhydramine).||
6324|132|I|   Check the labels on all your medicines (such as allergy or||
6324|133|I|cough-and-cold products) because they may contain ingredients||
6324|134|I|that cause drowsiness or they may contain similar ingredients||
6324|135|I|(decongestants such as phenylephrine). Ask your pharmacist about||
6324|136|I|using those products safely.||
6324|137|I|   Do not use with any other antihistamines applied to the skin||
6324|138|I|(such as diphenhydramine cream, ointment, spray) because||
6324|139|I|increased side effects may occur.||
6324|140|I|   Cetirizine is very similar to hydroxyzine and levocetirizine.||
6324|141|I|Do not use these medications while using cetirizine.||
6324|142|I|   This medication may interfere with certain lab tests (such as||
6324|143|I|allergy skin testing), possibly causing false test results. Make||
6324|144|I|sure lab personnel and all your doctors know you use this drug.||
6324|145|B|||
6324|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6324|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6324|148|O|poison control center right away. US residents can call||
6324|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6324|150|O|Symptoms of overdose may include: severe drowsiness,||
6324|151|O|fast/irregular heartbeat, mental/mood changes (such as anxiety,||
6324|152|O|restlessness), seizures.||
6324|153|B|||
6324|154|N|NOTES:  Keep all medical and lab appointments.||
6324|155|B|||
6324|156|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6324|157|D|remember. If it is near the time of the next dose, skip the||
6324|158|D|missed dose. Take your next dose at the regular time. Do not||
6324|159|D|double the dose to catch up.||
6324|160|B|||
6324|161|R|STORAGE:  Store at room temperature away from light and moisture.||
6324|162|R|Do not store in the bathroom. Different brands of this medication||
6324|163|R|may have different storage needs. Check the product package for||
6324|164|R|instructions on how to store your brand, or ask your pharmacist.||
6324|165|R|Keep all medications away from children and pets.||
6324|166|R|   Do not flush medications down the toilet or pour them into a||
6324|167|R|drain unless instructed to do so. Properly discard this product||
6324|168|R|when it is expired or no longer needed. Consult your pharmacist||
6324|169|R|or local waste disposal company.||
6324|170|B|||
6324|171|A|Information last revised July 2025.||
6324|172|A|Copyright(c) 2025 First Databank, Inc.||
6324|173|B|||
6326|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6326|002|Z|does NOT have all possible information about this product. This||
6326|003|Z|information does not assure that this product is safe, effective,||
6326|004|Z|or appropriate for you. This information is not individual||
6326|005|Z|medical advice and does not substitute for the advice of your||
6326|006|Z|health care professional. Always ask your health care||
6326|007|Z|professional for complete information about this product and your||
6326|008|Z|specific health needs.||
6326|009|B|||
6326|010|T|VORICONAZOLE - INJECTION||
6326|011|F|(VOR-i-KON-a-zole)||
6326|012|B|||
6326|013|C|COMMON BRAND NAME(S): Vfend||
6326|014|B|||
6326|015|U|USES:  Voriconazole is used to treat a variety of fungal||
6326|016|U|infections. It belongs to a class of drugs known as azole||
6326|017|U|antifungals. It works by stopping the growth of fungi.||
6326|018|B|||
6326|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6326|020|H|from your pharmacist before you start using voriconazole and each||
6326|021|H|time you get a refill. If you have any questions, ask your doctor||
6326|022|H|or pharmacist.||
6326|023|H|   This medication is given by injection into a vein as directed||
6326|024|H|by your doctor, usually every 12 hours. It should be injected||
6326|025|H|slowly over 1 to 2 hours.||
6326|026|H|   The dosage is based on your medical condition, weight,||
6326|027|H|response to treatment, and other medications you may be taking.||
6326|028|H|Be sure to tell your doctor and pharmacist about all the products||
6326|029|H|you use (including prescription drugs, nonprescription drugs, and||
6326|030|H|herbal products).||
6326|031|H|   If you are using this medication at home, learn all||
6326|032|H|preparation and usage instructions from your health care||
6326|033|H|professional. Before using, check this product for particles or||
6326|034|H|discoloration. If either is present, do not use the liquid. Learn||
6326|035|H|how to store and discard medical supplies safely.||
6326|036|H|   Infusion reactions may happen during the infusion of this||
6326|037|H|drug. Tell your doctor right away if you have symptoms of||
6326|038|H|infusion reactions such as flushing, fever, sweating, shortness||
6326|039|H|of breath, or nausea.||
6326|040|H|   For the best effect, use this antifungal at evenly spaced||
6326|041|H|times. To help you remember, use this medication at the same||
6326|042|H|times every day.||
6326|043|H|   Continue to use this medication until the full prescribed||
6326|044|H|amount is finished, even if symptoms disappear after a few days.||
6326|045|H|Stopping the medication too early may result in a return of the||
6326|046|H|infection.||
6326|047|H|   Tell your doctor if your condition does not get better or if||
6326|048|H|it gets worse.||
6326|049|B|||
6326|050|S|SIDE EFFECTS:  See also How to Use section.||
6326|051|S|   Nausea/vomiting and headache may occur. If any of these||
6326|052|S|effects last or get worse, tell your doctor or pharmacist||
6326|053|S|promptly.||
6326|054|S|   Remember that this medication has been prescribed because your||
6326|055|S|doctor has judged that the benefit to you is greater than the||
6326|056|S|risk of side effects. Many people using this medication do not||
6326|057|S|have serious side effects.||
6326|058|S|   Tell your doctor right away if you have any serious side||
6326|059|S|effects, including: vision changes (such as blurred vision, color||
6326|060|S|vision changes), sensitivity of eyes to light (photophobia), eye||
6326|061|S|pain, signs of kidney problems (such as change in the amount of||
6326|062|S|urine), bone/joint pain, mental/mood changes (such as||
6326|063|S|hallucinations), pain/swelling at injection site, swelling||
6326|064|S|hands/ankles/feet, easy bruising/bleeding, unusual skin changes,||
6326|065|S|signs of your adrenal glands not working well (such as loss of||
6326|066|S|appetite, unusual tiredness, weight loss).||
6326|067|S|   Get medical help right away if you have any very serious side||
6326|068|S|effects, including: fast/irregular heartbeat, severe dizziness,||
6326|069|S|fainting.||
6326|070|S|   Voriconazole may rarely cause serious (possibly fatal) liver||
6326|071|S|problems. Tell your doctor right away if you develop symptoms of||
6326|072|S|liver disease, such as: nausea/vomiting that doesn't stop, loss||
6326|073|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
6326|074|S|urine.||
6326|075|S|   A very serious allergic reaction to this drug is rare.||
6326|076|S|However, get medical help right away if you notice any symptoms||
6326|077|S|of a serious allergic reaction, including: fever that doesn't go||
6326|078|S|away, new or worsening lymph node swelling, rash,||
6326|079|S|itching/swelling (especially of the face/tongue/throat), severe||
6326|080|S|dizziness, trouble breathing.||
6326|081|S|   Voriconazole can commonly cause a mild rash that is usually||
6326|082|S|not serious. However, you may not be able to tell it apart from a||
6326|083|S|rare rash that could be a sign of a severe allergic reaction. Get||
6326|084|S|medical help right away if you develop any rash.||
6326|085|S|   This is not a complete list of possible side effects. If you||
6326|086|S|notice other effects not listed above, contact your doctor or||
6326|087|S|pharmacist.||
6326|088|S|   In the US -||
6326|089|S|   Call your doctor for medical advice about side effects. You||
6326|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6326|091|S|www.fda.gov/medwatch.||
6326|092|S|   In Canada - Call your doctor for medical advice about side||
6326|093|S|effects. You may report side effects to Health Canada at||
6326|094|S|1-866-234-2345.||
6326|095|B|||
6326|096|P|PRECAUTIONS:  Before using voriconazole, tell your doctor or||
6326|097|P|pharmacist if you are allergic to it; or to other azole||
6326|098|P|antifungals (such as itraconazole, ketoconazole); or if you have||
6326|099|P|any other allergies. This product may contain inactive||
6326|100|P|ingredients, which can cause allergic reactions or other||
6326|101|P|problems. Talk to your pharmacist for more details.||
6326|102|P|   Before using this medication, tell your doctor your medical||
6326|103|P|history, especially of: liver disease, kidney disease, heart||
6326|104|P|problems (such as irregular heartbeat).||
6326|105|P|   Voriconazole may cause a condition that affects the heart||
6326|106|P|rhythm (QT prolongation). QT prolongation can rarely cause||
6326|107|P|serious (rarely fatal) fast/irregular heartbeat and other||
6326|108|P|symptoms (such as severe dizziness, fainting) that need medical||
6326|109|P|attention right away.||
6326|110|P|   The risk of QT prolongation may be increased if you have||
6326|111|P|certain medical conditions or are taking other drugs that may||
6326|112|P|cause QT prolongation. Before using voriconazole, tell your||
6326|113|P|doctor or pharmacist of all the drugs you take and if you have||
6326|114|P|any of the following conditions: certain heart problems (heart||
6326|115|P|failure, slow heartbeat, QT prolongation in the EKG), family||
6326|116|P|history of certain heart problems (QT prolongation in the EKG,||
6326|117|P|sudden cardiac death).||
6326|118|P|   Low levels of potassium or magnesium in the blood may also||
6326|119|P|increase your risk of QT prolongation. This risk may increase if||
6326|120|P|you use certain drugs (such as diuretics/"water pills") or if you||
6326|121|P|have conditions such as severe sweating, diarrhea, or vomiting.||
6326|122|P|Talk to your doctor about using voriconazole safely.||
6326|123|P|   This drug may cause vision changes. Do not drive, use||
6326|124|P|machinery, or do anything that needs clear vision until you can||
6326|125|P|do it safely. Do not drive at night.||
6326|126|P|   Avoid alcoholic beverages because they can increase the risk||
6326|127|P|of serious liver problems.||
6326|128|P|   This medication may make you more sensitive to the sun. It may||
6326|129|P|also increase your risk for skin cancer, especially if you use it||
6326|130|P|for a long time. Limit your time in the sun. Avoid tanning booths||
6326|131|P|and sunlamps. Use sunscreen and wear protective clothing when||
6326|132|P|outdoors. Tell your doctor right away if you get sunburned or||
6326|133|P|have skin blisters/redness, or notice new or changed moles/skin||
6326|134|P|lesions.||
6326|135|P|   Before having surgery, tell your doctor or dentist about all||
6326|136|P|the products you use (including prescription drugs,||
6326|137|P|nonprescription drugs, and herbal products).||
6326|138|P|   Older adults may be more sensitive to the side effects of this||
6326|139|P|drug, especially QT prolongation (see above).||
6326|140|P|   Children may be at greater risk for liver problems and being||
6326|141|P|more sensitive to the sun while using this drug (see above).||
6326|142|P|   Tell your doctor if you are pregnant or plan to become||
6326|143|P|pregnant. You should not become pregnant while using||
6326|144|P|voriconazole. Voriconazole may harm an unborn baby. Ask about||
6326|145|P|reliable forms of birth control while using this medication. If||
6326|146|P|you become pregnant, talk to your doctor right away about the||
6326|147|P|risks and benefits of this medication.||
6326|148|P|   It is unknown if this medication passes into breast milk.||
6326|149|P|Because of the possible risk to the infant, breastfeeding is not||
6326|150|P|recommended while using this medication. Consult your doctor||
6326|151|P|before breastfeeding.||
6326|152|B|||
6326|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6326|154|I|medications work or increase your risk for serious side effects.||
6326|155|I|This document does not contain all possible drug interactions.||
6326|156|I|Keep a list of all the products you use (including||
6326|157|I|prescription/nonprescription drugs and herbal products) and share||
6326|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
6326|159|I|the dosage of any medicines without your doctor's approval.||
6326|160|I|   Voriconazole can slow down the removal of other medications||
6326|161|I|from your body, which may affect how they work. Examples of||
6326|162|I|affected drugs include eletriptan, ergot alkaloids (such as||
6326|163|I|dihydroergotamine, ergotamine), certain drugs to treat irregular||
6326|164|I|heartbeat (such disopyramide, dronedarone, quinidine),||
6326|165|I|ivabradine, lurasidone, naloxegol, pimozide, ranolazine,||
6326|166|I|sirolimus, certain "statin" cholesterol drugs (such as||
6326|167|I|lovastatin, simvastatin), tolvaptan, among others.||
6326|168|I|   Other medications can affect the removal of voriconazole from||
6326|169|I|your body, which may affect how voriconazole works. Examples||
6326|170|I|include butalbital, efavirenz, mitotane, rifamycins (such as||
6326|171|I|rifabutin, rifampin), ritonavir, secobarbital, certain drugs used||
6326|172|I|to treat seizures (such as carbamazepine, phenobarbital), St.||
6326|173|I|John's wort, among others.||
6326|174|I|   Many drugs besides voriconazole may affect the heart rhythm||
6326|175|I|(QT prolongation), including pacritinib, among others.||
6326|176|B|||
6326|177|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6326|178|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6326|179|O|poison control center right away. US residents can call||
6326|180|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6326|181|B|||
6326|182|N|NOTES:  Lab and/or medical tests (such as liver/kidney function,||
6326|183|N|blood mineral levels) should be done before you start using this||
6326|184|N|medication and while you are using it. Keep all medical and lab||
6326|185|N|appointments. Consult your doctor for more details.||
6326|186|B|||
6326|187|D|MISSED DOSE:  It is important to get each dose of this medication||
6326|188|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6326|189|D|right away for a new dosing schedule. Do not double the dose to||
6326|190|D|catch up.||
6326|191|B|||
6326|192|R|STORAGE:  Consult the product instructions and your pharmacist||
6326|193|R|for storage details. Keep all medications away from children and||
6326|194|R|pets.||
6326|195|R|   Do not flush medications down the toilet or pour them into a||
6326|196|R|drain unless instructed to do so. Properly discard this product||
6326|197|R|when it is expired or no longer needed. Consult your pharmacist||
6326|198|R|or local waste disposal company.||
6326|199|B|||
6326|200|A|Information last revised April 2025.||
6326|201|A|Copyright(c) 2025 First Databank, Inc.||
6326|202|B|||
6327|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6327|002|Z|does NOT have all possible information about this product. This||
6327|003|Z|information does not assure that this product is safe, effective,||
6327|004|Z|or appropriate for you. This information is not individual||
6327|005|Z|medical advice and does not substitute for the advice of your||
6327|006|Z|health care professional. Always ask your health care||
6327|007|Z|professional for complete information about this product and your||
6327|008|Z|specific health needs.||
6327|009|B|||
6327|010|T|IMATINIB - ORAL||
6327|011|F|(im-A-ti-nib)||
6327|012|B|||
6327|013|C|COMMON BRAND NAME(S):  Imkeldi, Gleevec||
6327|014|B|||
6327|015|U|USES:  This medication is used to treat certain types of cancer||
6327|016|U|(such as acute lymphoblastic leukemia, chronic myeloid leukemia,||
6327|017|U|gastrointestinal stromal tumors, and||
6327|018|U|myelodysplastic/myeloproliferative diseases). It works by slowing||
6327|019|U|or stopping the growth of cancer cells. Imatinib may also be used||
6327|020|U|to treat certain immune system disorders (such as aggressive||
6327|021|U|systemic mastocytosis, hypereosinophilic syndrome).||
6327|022|B|||
6327|023|H|HOW TO USE:  Read the Instructions for Use if available from your||
6327|024|H|pharmacist before you start using this medication and each time||
6327|025|H|you get a refill. If you have any questions, ask your doctor or||
6327|026|H|pharmacist.||
6327|027|H|   Take this medication by mouth with a meal and a full glass of||
6327|028|H|water (8 ounces/240 milliliters) as directed by your doctor,||
6327|029|H|usually once or twice daily. Do not crush the tablets. If you||
6327|030|H|have trouble swallowing the tablets whole, you may dissolve the||
6327|031|H|tablets in a glass of water or apple juice. The amount of liquid||
6327|032|H|will depend on your dose. Consult your doctor or pharmacist for||
6327|033|H|more detailed instructions. Stir the mixture well until the||
6327|034|H|tablet(s) dissolve, and drink right away.||
6327|035|H|   If you are using the liquid form of this medication, carefully||
6327|036|H|measure the dose using a special measuring device/spoon. Do not||
6327|037|H|use a household spoon because you may not get the correct dose.||
6327|038|H|   The dosage is based on your medical condition, response to||
6327|039|H|treatment, and other medications you may be taking. Children's||
6327|040|H|dosage is also based on body size. Be sure to tell your doctor||
6327|041|H|and pharmacist about all the products you use (including||
6327|042|H|prescription drugs, nonprescription drugs, and herbal products).||
6327|043|H|   Avoid eating grapefruit or drinking grapefruit juice while||
6327|044|H|using this medication unless your doctor or pharmacist says you||
6327|045|H|may do so safely. Grapefruit can increase the chance of side||
6327|046|H|effects with this medicine. Ask your doctor or pharmacist for||
6327|047|H|more details.||
6327|048|H|   Do not increase your dose or use this drug more often or for||
6327|049|H|longer than prescribed. Your condition will not improve any||
6327|050|H|faster, and your risk of side effects will increase.||
6327|051|H|   Since this drug can be absorbed through the skin and lungs and||
6327|052|H|may harm an unborn baby, women who are pregnant or who may become||
6327|053|H|pregnant should not handle this medication or breathe the dust||
6327|054|H|from the tablets.||
6327|055|B|||
6327|056|S|SIDE EFFECTS:  Upset stomach, nausea/vomiting, diarrhea,||
6327|057|S|headache, muscle/joint pain, muscle cramps, dizziness, blurred||
6327|058|S|vision, or drowsiness may occur. If any of these effects last or||
6327|059|S|get worse, tell your doctor or pharmacist promptly.||
6327|060|S|   People using this medication may have serious side effects.||
6327|061|S|However, you have been prescribed this drug because your doctor||
6327|062|S|has judged that the benefit to you is greater than the risk of||
6327|063|S|side effects. Careful monitoring by your doctor may decrease your||
6327|064|S|risk.||
6327|065|S|   Tell your doctor right away if you have any serious side||
6327|066|S|effects, including: easy bruising/bleeding, unusual tiredness,||
6327|067|S|sudden/unexplained weight gain, swelling||
6327|068|S|hands/ankles/feet/abdomen, swelling around the eyes, shortness of||
6327|069|S|breath, fast heartbeat, black/bloody stools, vomit that looks||
6327|070|S|like coffee grounds, symptoms of liver disease (such as||
6327|071|S|nausea/vomiting that doesn't stop, loss of appetite,||
6327|072|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
6327|073|S|   This medication may lower your ability to fight infections.||
6327|074|S|This may make you more likely to get a serious infection or make||
6327|075|S|any infection you have worse. Tell your doctor right away if you||
6327|076|S|have any signs of infection (such as sore throat that doesn't go||
6327|077|S|away, fever, chills).||
6327|078|S|   Imatinib sometimes causes side effects due to the rapid||
6327|079|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
6327|080|S|risk, drink plenty of fluids unless your doctor directs you||
6327|081|S|otherwise. Also, your doctor may prescribe an additional||
6327|082|S|medication. Tell your doctor right away if you have symptoms such||
6327|083|S|as: low back/side pain (flank pain), signs of kidney problems||
6327|084|S|(such as painful urination, pink/bloody urine, change in the||
6327|085|S|amount of urine), muscle spasms/weakness.||
6327|086|S|   Imatinib can commonly cause a rash that is usually not||
6327|087|S|serious. However, you may not be able to tell it apart from a||
6327|088|S|rare rash that could be a sign of a severe reaction. Get medical||
6327|089|S|help right away if you develop any rash.||
6327|090|S|   A very serious allergic reaction to this drug is rare.||
6327|091|S|However, get medical help right away if you notice any symptoms||
6327|092|S|of a serious allergic reaction, including: rash, itching/swelling||
6327|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6327|094|S|breathing.||
6327|095|S|   This is not a complete list of possible side effects. If you||
6327|096|S|notice any other effects not listed above, contact your doctor or||
6327|097|S|pharmacist.||
6327|098|S|   In the US -||
6327|099|S|   Call your doctor for medical advice about side effects. You||
6327|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6327|101|S|www.fda.gov/medwatch.||
6327|102|S|   In Canada - Call your doctor for medical advice about side||
6327|103|S|effects. You may report side effects to Health Canada at||
6327|104|S|1-866-234-2345.||
6327|105|B|||
6327|106|P|PRECAUTIONS:  Before taking imatinib, tell your doctor or||
6327|107|P|pharmacist if you are allergic to it; or if you have any other||
6327|108|P|allergies. This product may contain inactive ingredients, which||
6327|109|P|can cause allergic reactions or other problems. Talk to your||
6327|110|P|pharmacist for more details.||
6327|111|P|   Before using this medication, tell your doctor or pharmacist||
6327|112|P|your medical history, especially of: bleeding problems, heart||
6327|113|P|problems (such as heart failure), kidney disease, liver disease,||
6327|114|P|removal of thyroid gland.||
6327|115|P|   This drug may make you dizzy or drowsy or blur your vision.||
6327|116|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
6327|117|P|drowsy. Do not drive, use machinery, or do anything that needs||
6327|118|P|alertness or clear vision until you can do it safely. Limit||
6327|119|P|alcoholic beverages. Talk to your doctor if you are using||
6327|120|P|marijuana (cannabis).||
6327|121|P|   Imatinib can make you more likely to get infections or may||
6327|122|P|make current infections worse. Stay away from anyone who has an||
6327|123|P|infection that may easily spread (such as chickenpox, COVID-19,||
6327|124|P|measles, flu). Talk to your doctor if you have been exposed to an||
6327|125|P|infection or for more details.||
6327|126|P|   Tell your health care professional that you are using imatinib||
6327|127|P|before having any immunizations/vaccinations. Avoid contact with||
6327|128|P|people who have recently received live vaccines (such as flu||
6327|129|P|vaccine inhaled through the nose).||
6327|130|P|   To lower the chance of getting cut, bruised, or injured, use||
6327|131|P|caution with sharp objects like razors and nail cutters, and||
6327|132|P|avoid activities such as contact sports.||
6327|133|P|   Before having surgery, tell your doctor or dentist about all||
6327|134|P|the products you use (including prescription drugs,||
6327|135|P|nonprescription drugs, and herbal products).||
6327|136|P|   This medication may slow down a child's growth. The effect on||
6327|137|P|final adult height is unknown. See the doctor regularly so your||
6327|138|P|child's height and weight can be checked.||
6327|139|P|   Older adults may be more sensitive to the side effects of this||
6327|140|P|drug, especially swelling (edema).||
6327|141|P|   Since this drug can be absorbed through the skin and lungs and||
6327|142|P|may harm an unborn baby, women who are pregnant or who may become||
6327|143|P|pregnant should not handle this medication or breathe the dust||
6327|144|P|from the tablets.||
6327|145|P|   Tell your doctor if you are pregnant or plan to become||
6327|146|P|pregnant. You should not become pregnant while using imatinib.||
6327|147|P|Imatinib may harm an unborn baby. Your doctor should order a||
6327|148|P|pregnancy test 1 week before you start this medication. Ask about||
6327|149|P|reliable forms of birth control while using this medication and||
6327|150|P|for 2 weeks after the last dose. If you become pregnant, talk to||
6327|151|P|your doctor right away about the risks and benefits of this||
6327|152|P|medication.||
6327|153|P|   This medication passes into breast milk. Because of possible||
6327|154|P|risk to the infant, breastfeeding is not recommended while using||
6327|155|P|this medication and for 1 month after the last dose. Consult your||
6327|156|P|doctor before breastfeeding.||
6327|157|B|||
6327|158|I|DRUG INTERACTIONS:  See also How to Use section.||
6327|159|I|   Drug interactions may change how your medications work or||
6327|160|I|increase your risk for serious side effects. This document does||
6327|161|I|not contain all possible drug interactions. Keep a list of all||
6327|162|I|the products you use (including prescription/nonprescription||
6327|163|I|drugs and herbal products) and share it with your doctor and||
6327|164|I|pharmacist. Do not start, stop, or change the dosage of any||
6327|165|I|medicines without your doctor's approval.||
6327|166|I|   This medication can slow down the removal of other medications||
6327|167|I|from your body, which may affect how they work. Examples of||
6327|168|I|affected drugs include elacestrant, flibanserin, irinotecan,||
6327|169|I|lomitapide, warfarin, among others.||
6327|170|B|||
6327|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6327|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6327|173|O|poison control center right away. US residents can call||
6327|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6327|175|B|||
6327|176|N|NOTES:  Do not share this medication with others.||
6327|177|N|   Lab and/or medical tests (such as complete blood count,||
6327|178|N|liver/kidney function, body weight) should be done before you||
6327|179|N|start taking this medication and while you are taking it. Keep||
6327|180|N|all medical and lab appointments.||
6327|181|B|||
6327|182|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
6327|183|D|next dose at the regular time. Do not double the dose to catch||
6327|184|D|up.||
6327|185|B|||
6327|186|R|STORAGE:  Store at room temperature away from light and moisture.||
6327|187|R|Do not store in the bathroom. Store the liquid form in the||
6327|188|R|original bottle and discard 30 days after opening. Keep all||
6327|189|R|medications away from children and pets.||
6327|190|R|   Do not flush medications down the toilet or pour them into a||
6327|191|R|drain unless instructed to do so. Properly discard this product||
6327|192|R|when it is expired or no longer needed. Consult your pharmacist||
6327|193|R|or local waste disposal company.||
6327|194|B|||
6327|195|M|MEDICAL ALERT:  Your condition can cause complications in a||
6327|196|M|medical emergency. For information about enrolling in MedicAlert,||
6327|197|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6327|198|B|||
6327|199|A|Information last revised December 2024.||
6327|200|A|Copyright(c) 2025 First Databank, Inc.||
6327|201|B|||
6330|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6330|002|Z|does NOT have all possible information about this product. This||
6330|003|Z|information does not assure that this product is safe, effective,||
6330|004|Z|or appropriate for you. This information is not individual||
6330|005|Z|medical advice and does not substitute for the advice of your||
6330|006|Z|health care professional. Always ask your health care||
6330|007|Z|professional for complete information about this product and your||
6330|008|Z|specific health needs.||
6330|009|B|||
6330|010|T|TENOFOVIR - ORAL||
6330|011|F|(ten-OF-oh-vir)||
6330|012|B|||
6330|013|C|COMMON BRAND NAME(S): Viread||
6330|014|B|||
6330|015|W|WARNING:  If you have hepatitis B infection, your hepatitis||
6330|016|W|symptoms may get worse or become very serious if you stop taking||
6330|017|W|tenofovir. Talk with your doctor before stopping this medication.||
6330|018|W|Your doctor will monitor liver tests for several months after you||
6330|019|W|stop tenofovir. Tell your doctor right away if you develop||
6330|020|W|symptoms of worsening liver problems.||
6330|021|B|||
6330|022|U|USES:  Tenofovir is used with other HIV medications to help||
6330|023|U|control HIV infection. It helps to decrease the amount of HIV in||
6330|024|U|your body so your immune system can work better. This lowers your||
6330|025|U|chance of getting HIV complications (such as new infections,||
6330|026|U|cancer) and improves your quality of life. Tenofovir belongs to a||
6330|027|U|class of drugs known as nucleotide reverse transcriptase||
6330|028|U|inhibitors (NRTIs).||
6330|029|U|   Tenofovir is not a cure for HIV infection. To decrease your||
6330|030|U|risk of spreading HIV disease to others, continue to take all HIV||
6330|031|U|medications exactly as prescribed by your doctor. Use an||
6330|032|U|effective barrier method (latex or polyurethane condoms/dental||
6330|033|U|dams) during sexual activity as directed by your doctor. Do not||
6330|034|U|share personal items (such as needles/syringes, toothbrushes, and||
6330|035|U|razors) that may have contacted blood or other body fluids.||
6330|036|U|Consult your doctor or pharmacist for more details.||
6330|037|U|   Tenofovir is also used to treat a certain type of liver||
6330|038|U|infection called chronic hepatitis B infection. It helps to||
6330|039|U|decrease the amount of hepatitis B virus in your body by||
6330|040|U|interfering with virus growth.||
6330|041|B|||
6330|042|V|OTHER USES:  This section contains uses of this drug that are not||
6330|043|V|listed in the approved professional labeling for the drug but||
6330|044|V|that may be prescribed by your health care professional. Use this||
6330|045|V|drug for a condition that is listed in this section only if it||
6330|046|V|has been so prescribed by your health care professional.||
6330|047|V|   This product may also be used to lessen the risk of HIV||
6330|048|V|infection after contact with the virus (for example, due to a||
6330|049|V|needle stick). Ask your doctor for more details.||
6330|050|B|||
6330|051|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6330|052|H|from your pharmacist before you start taking tenofovir, and each||
6330|053|H|time you get a refill. If you have any questions, ask your doctor||
6330|054|H|or pharmacist.||
6330|055|H|   Take this medication by mouth with or without food as directed||
6330|056|H|by your doctor, usually once daily.||
6330|057|H|   The dosage is based on your medical condition and response to||
6330|058|H|treatment. Children's dosage is also based on weight.||
6330|059|H|   It is very important to keep taking this medication (and other||
6330|060|H|HIV medications) exactly as prescribed by your doctor. Do not||
6330|061|H|skip any doses. Do not increase your dose, take this drug more||
6330|062|H|often than prescribed, or stop taking it (or other HIV medicines)||
6330|063|H|even for a short time unless directed to do so by your doctor.||
6330|064|H|Skipping or changing your dose without approval from your doctor||
6330|065|H|may cause the amount of virus to increase, make the infection||
6330|066|H|more difficult to treat (resistant), or worsen side effects.||
6330|067|H|   For the best effect, take this medication at evenly spaced||
6330|068|H|times. To help you remember, take this medication at the same||
6330|069|H|time every day.||
6330|070|B|||
6330|071|S|SIDE EFFECTS:  Dizziness, diarrhea, headache, or trouble sleeping||
6330|072|S|may occur. If any of these effects last or get worse, tell your||
6330|073|S|doctor or pharmacist promptly.||
6330|074|S|   Remember that this medication has been prescribed because your||
6330|075|S|doctor has judged that the benefit to you is greater than the||
6330|076|S|risk of side effects. Many people using this medication do not||
6330|077|S|have serious side effects.||
6330|078|S|   As your immune system gets stronger with HIV treatment, it can||
6330|079|S|begin to fight off infections you already had, possibly causing||
6330|080|S|disease symptoms to come back. You could also have symptoms if||
6330|081|S|your immune system becomes overactive. This reaction may happen||
6330|082|S|at any time (soon after starting HIV treatment or many months||
6330|083|S|later). Tell your doctor right away if you have any serious||
6330|084|S|symptoms, including: unexplained weight loss, severe tiredness,||
6330|085|S|muscle aches/weakness that doesn't go away, headaches that are||
6330|086|S|severe or don't go away, joint pain, numbness/tingling of the||
6330|087|S|hands/feet/arms/legs, vision changes, signs of infection (such as||
6330|088|S|sore throat the doesn't go away, fever, chills, swollen lymph||
6330|089|S|nodes, non-healing skin sores), signs of an overactive thyroid||
6330|090|S|(such as irritability, nervousness, heat intolerance,||
6330|091|S|fast/pounding/irregular heartbeat).||
6330|092|S|   Tell your doctor right away if you have any serious side||
6330|093|S|effects, including: mental/mood changes (such as depression,||
6330|094|S|anxiety, confusion), signs of kidney problems (such as a change||
6330|095|S|in the amount of urine), unusual thirst.||
6330|096|S|   Rarely, this medication can cause severe (sometimes fatal)||
6330|097|S|liver and blood problems (lactic acidosis). Tell your doctor||
6330|098|S|right away if you develop symptoms of liver problems (such as||
6330|099|S|nausea/vomiting that doesn't stop, loss of appetite,||
6330|100|S|stomach/abdominal pain, yellowing eyes/skin, dark urine) or||
6330|101|S|lactic acidosis (such as deep/rapid breathing, drowsiness,||
6330|102|S|nausea/vomiting, unusual weakness).||
6330|103|S|   Tenofovir may increase the risk of bone loss. Discuss the||
6330|104|S|risks and benefits of treatment with your doctor, as well as the||
6330|105|S|possible use of calcium and vitamin D to reduce this side effect.||
6330|106|S|If you are at risk for bone loss, your doctor may monitor your||
6330|107|S|bone mineral density. Tell your doctor right away if any of the||
6330|108|S|following serious side effects occur: bone pain, easily broken||
6330|109|S|bones.||
6330|110|S|   Tenofovir can commonly cause a rash that is usually not||
6330|111|S|serious. However, you may not be able to tell it apart from a||
6330|112|S|rare rash that could be a sign of a severe reaction. Get medical||
6330|113|S|help right away if you develop any rash.||
6330|114|S|   A very serious allergic reaction to this drug is rare.||
6330|115|S|However, get medical help right away if you notice any symptoms||
6330|116|S|of a serious allergic reaction, including: rash, itching/swelling||
6330|117|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6330|118|S|breathing.||
6330|119|S|   This is not a complete list of possible side effects. If you||
6330|120|S|notice other effects not listed above, contact your doctor or||
6330|121|S|pharmacist.||
6330|122|S|   In the US -||
6330|123|S|   Call your doctor for medical advice about side effects. You||
6330|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6330|125|S|www.fda.gov/medwatch.||
6330|126|S|   In Canada - Call your doctor for medical advice about side||
6330|127|S|effects. You may report side effects to Health Canada at||
6330|128|S|1-866-234-2345.||
6330|129|B|||
6330|130|P|PRECAUTIONS:  Before taking tenofovir, tell your doctor or||
6330|131|P|pharmacist if you are allergic to it; or if you have any other||
6330|132|P|allergies. This product may contain inactive ingredients, which||
6330|133|P|can cause allergic reactions or other problems. Talk to your||
6330|134|P|pharmacist for more details.||
6330|135|P|   Before using this medication, tell your doctor or pharmacist||
6330|136|P|your medical history, especially of: kidney problems, liver||
6330|137|P|problems (such as hepatitis C, cirrhosis), bone problems (such as||
6330|138|P|bone disease, bone loss/osteoporosis, weak/broken bones), disease||
6330|139|P|of the pancreas (pancreatitis), alcohol use.||
6330|140|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6330|141|P|can make you more dizzy. Do not drive, use machinery, or do||
6330|142|P|anything that needs alertness until you can do it safely. Limit||
6330|143|P|alcoholic beverages. Talk to your doctor if you are using||
6330|144|P|marijuana (cannabis).||
6330|145|P|   Also limit alcohol because it may increase your risk of liver||
6330|146|P|problems and pancreatitis.||
6330|147|P|   Before having surgery, tell your doctor or dentist about all||
6330|148|P|the products you use (including prescription drugs,||
6330|149|P|nonprescription drugs, and herbal products).||
6330|150|P|   During pregnancy, this medication should be used only when||
6330|151|P|clearly needed. Discuss the risks and benefits with your doctor.||
6330|152|P|If you have HIV infection, treatment can lower the risk of||
6330|153|P|passing HIV infection to your baby, and tenofovir may be part of||
6330|154|P|that treatment.||
6330|155|P|   This medication passes into breast milk, but is unlikely to||
6330|156|P|harm a nursing infant. If you have HIV, breast milk may transmit||
6330|157|P|HIV. Consult your doctor before breastfeeding.||
6330|158|B|||
6330|159|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6330|160|I|medications work or increase your risk for serious side effects.||
6330|161|I|This document does not contain all possible drug interactions.||
6330|162|I|Keep a list of all the products you use (including||
6330|163|I|prescription/nonprescription drugs and herbal products) and share||
6330|164|I|it with your doctor and pharmacist. Do not start, stop, or change||
6330|165|I|the dosage of any medicines without your doctor's approval.||
6330|166|I|   Some products that may interact with this drug include:||
6330|167|I|adefovir, orlistat, other drugs that may harm the kidneys||
6330|168|I|(including aminoglycosides such as amikacin/gentamicin).||
6330|169|I|   Do not take this medication with other products that contain||
6330|170|I|tenofovir.||
6330|171|I|   Some other drugs to treat HIV infection (including atazanavir)||
6330|172|I|may also interact with tenofovir. Tenofovir can decrease the||
6330|173|I|effectiveness of atazanavir (by decreasing blood levels). If you||
6330|174|I|are taking atazanavir with this product, you may need to also||
6330|175|I|take another medication (ritonavir). Consult your doctor or||
6330|176|I|pharmacist for more details. Your doctor will adjust your||
6330|177|I|medications and monitor your treatment to reduce the risk of side||
6330|178|I|effects.||
6330|179|B|||
6330|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6330|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6330|182|O|poison control center right away. US residents can call||
6330|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6330|184|B|||
6330|185|N|NOTES:  Do not share this medication with others.||
6330|186|N|   Lab and/or medical tests (such as kidney/liver function, urine||
6330|187|N|glucose/protein, viral load, T-cell counts, blood mineral levels,||
6330|188|N|bone density tests) should be done before you start taking this||
6330|189|N|medication and while you are taking it. Keep all medical and lab||
6330|190|N|appointments. Consult your doctor for more details.||
6330|191|B|||
6330|192|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6330|193|D|remember. If it is near the time of the next dose, skip the||
6330|194|D|missed dose. Take your next dose at the regular time. Do not||
6330|195|D|double the dose to catch up.||
6330|196|B|||
6330|197|R|STORAGE:  Store in the original container at room temperature||
6330|198|R|away from light and moisture. Do not store in the bathroom. Keep||
6330|199|R|all medications away from children and pets.||
6330|200|R|   Do not flush medications down the toilet or pour them into a||
6330|201|R|drain unless instructed to do so. Properly discard this product||
6330|202|R|when it is expired or no longer needed. Consult your pharmacist||
6330|203|R|or local waste disposal company.||
6330|204|B|||
6330|205|A|Information last revised April 2025.||
6330|206|A|Copyright(c) 2025 First Databank, Inc.||
6330|207|B|||
6333|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6333|002|Z|does NOT have all possible information about this product. This||
6333|003|Z|information does not assure that this product is safe, effective,||
6333|004|Z|or appropriate for you. This information is not individual||
6333|005|Z|medical advice and does not substitute for the advice of your||
6333|006|Z|health care professional. Always ask your health care||
6333|007|Z|professional for complete information about this product and your||
6333|008|Z|specific health needs.||
6333|009|B|||
6333|010|T|BECLOMETHASONE HFA INHALER - ORAL INHALATION||
6333|011|F|(BE-kloe-METH-a-sone)||
6333|012|B|||
6333|013|C|COMMON BRAND NAME(S): Qvar||
6333|014|B|||
6333|015|U|USES:  Beclomethasone is used to prevent and control symptoms||
6333|016|U|(wheezing and shortness of breath) caused by asthma. This||
6333|017|U|medication belongs to a class of drugs known as corticosteroids.||
6333|018|U|It works directly in the lungs to make breathing easier by||
6333|019|U|reducing the irritation and swelling of the airways.||
6333|020|U|   This medication must be used regularly to prevent breathing||
6333|021|U|problems (attacks of wheezing/shortness of breath). It does not||
6333|022|U|work right away and should not be used to relieve an asthma||
6333|023|U|attack. If an attack occurs, use your quick-relief inhaler as||
6333|024|U|prescribed.||
6333|025|B|||
6333|026|V|OTHER USES:  This section contains uses of this drug that are not||
6333|027|V|listed in the approved professional labeling for the drug but||
6333|028|V|that may be prescribed by your health care professional. Use this||
6333|029|V|drug for a condition that is listed in this section only if it||
6333|030|V|has been so prescribed by your health care professional.||
6333|031|V|   This drug may also be used for lung diseases such as||
6333|032|V|bronchitis and emphysema.||
6333|033|B|||
6333|034|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
6333|035|H|your pharmacist before you start using this medication and each||
6333|036|H|time you get a refill. Follow the illustrated directions for the||
6333|037|H|proper use of this medication. If you have any questions, ask||
6333|038|H|your doctor, pharmacist, or respiratory therapist.||
6333|039|H|   Follow the instructions for priming the inhaler if you are||
6333|040|H|using a canister for the first time or if you have not used it||
6333|041|H|for 10 days or more. There is no need to shake the inhaler. Avoid||
6333|042|H|getting the medication in your eyes when priming or using the||
6333|043|H|inhaler.||
6333|044|H|   Inhale this medication by mouth as directed by your doctor,||
6333|045|H|usually 2 times a day. The dosage is based on your age, medical||
6333|046|H|condition and response to treatment.||
6333|047|H|   If your prescribed dose is 2 puffs, wait at least one minute||
6333|048|H|between them. If you are using other inhalers at the same time,||
6333|049|H|wait at least 1 minute between the use of each medication, and||
6333|050|H|use this drug (the corticosteroid) last.||
6333|051|H|   To prevent dry mouth, hoarseness, and oral yeast infections||
6333|052|H|from developing, gargle, rinse your mouth with water and spit out||
6333|053|H|after each use. Do not swallow the rinse water.||
6333|054|H|   Keep track of the number of inhalations used. Discard the||
6333|055|H|canister after using the labeled number of inhalations on the||
6333|056|H|package, even if it feels as though there is medication left in||
6333|057|H|the canister. Follow the instructions for cleaning the inhaler.||
6333|058|H|Do not wash the inhaler or put any part of it in water.||
6333|059|H|   Use this medication regularly to get the most benefit from it.||
6333|060|H|To help you remember, use it at the same time(s) each day. Do not||
6333|061|H|increase your dose or use this drug more often or for longer than||
6333|062|H|prescribed. Your condition will not improve any faster, and your||
6333|063|H|risk of side effects will increase.||
6333|064|H|   Do not stop taking this medication without consulting your||
6333|065|H|doctor. Some conditions may become worse when the drug is||
6333|066|H|suddenly stopped. Your dose may need to be gradually decreased.||
6333|067|H|   Learn which of your inhalers you should use every day||
6333|068|H|(controller drugs) and which you should use if your breathing||
6333|069|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
6333|070|H|time what you should do if you have new or worsening cough or||
6333|071|H|shortness of breath, wheezing, increased sputum, worsening peak||
6333|072|H|flow meter readings, waking up at night with trouble breathing,||
6333|073|H|if you use your quick-relief inhaler more often (more than 2 days||
6333|074|H|a week), or if your quick-relief inhaler does not seem to be||
6333|075|H|working well. Learn when you can treat sudden breathing problems||
6333|076|H|by yourself and when you must get medical help right away.||
6333|077|H|   If you are regularly taking a different corticosteroid by||
6333|078|H|mouth (such as prednisone), you should not stop taking it unless||
6333|079|H|directed by your doctor. Some conditions (such as asthma,||
6333|080|H|allergies) may become worse when the drug is suddenly stopped. If||
6333|081|H|you suddenly stop taking the drug, you may also have withdrawal||
6333|082|H|symptoms (such as weakness, weight loss, nausea, muscle pain,||
6333|083|H|headache, tiredness, dizziness). To help prevent withdrawal, your||
6333|084|H|doctor may slowly lower the dose of your old medication after you||
6333|085|H|begin using beclomethasone. Tell your doctor or pharmacist right||
6333|086|H|away if you have withdrawal. See also Precautions section.||
6333|087|H|   You may begin to feel this medication working within 24 hours,||
6333|088|H|but it may take 3 weeks or longer before the full benefit of this||
6333|089|H|drug takes effect. Tell your doctor if your condition does not||
6333|090|H|get better or if it gets worse.||
6333|091|B|||
6333|092|S|SIDE EFFECTS:  See also Precautions section.||
6333|093|S|   Dry/sore throat, hoarseness, a bad taste in the mouth,||
6333|094|S|headache, or voice changes may occur. If any of these effects||
6333|095|S|last or get worse, tell your doctor or pharmacist promptly.||
6333|096|S|   Remember that this medication has been prescribed because your||
6333|097|S|doctor has judged that the benefit to you is greater than the||
6333|098|S|risk of side effects. Many people using this medication do not||
6333|099|S|have serious side effects.||
6333|100|S|   Rarely, this medication may cause severe sudden worsening of||
6333|101|S|breathing problems/asthma immediately after use. If you have||
6333|102|S|sudden worsening of breathing, use your quick-relief inhaler and||
6333|103|S|get medical help right away.||
6333|104|S|   Because this drug works by weakening the immune system, it may||
6333|105|S|lower your ability to fight infections. This may make you more||
6333|106|S|likely to get a serious (rarely fatal) infection or make any||
6333|107|S|infection you have worse. Tell your doctor right away if you have||
6333|108|S|any signs of infection (such as sore throat that doesn't go away,||
6333|109|S|fever, chills). Use of this medication for prolonged or repeated||
6333|110|S|periods may result in oral thrush (yeast infection). Contact your||
6333|111|S|doctor if you notice white patches in your mouth or on your||
6333|112|S|tongue.||
6333|113|S|   Tell your doctor right away if you have any serious side||
6333|114|S|effects, including: unusual tiredness, vision problems, easy||
6333|115|S|bruising/bleeding, puffy face, unusual hair growth, mental/mood||
6333|116|S|changes (such as depression, mood swings, agitation), muscle||
6333|117|S|weakness/pain, thinning skin, slow wound healing, increased||
6333|118|S|thirst/urination.||
6333|119|S|   A very serious allergic reaction to this drug is rare.||
6333|120|S|However, get medical help right away if you notice any symptoms||
6333|121|S|of a serious allergic reaction, including: rash, itching/swelling||
6333|122|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6333|123|S|breathing.||
6333|124|S|   This is not a complete list of possible side effects. If you||
6333|125|S|notice other effects not listed above, contact your doctor or||
6333|126|S|pharmacist.||
6333|127|S|   In the US -||
6333|128|S|   Call your doctor for medical advice about side effects. You||
6333|129|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6333|130|S|www.fda.gov/medwatch.||
6333|131|S|   In Canada - Call your doctor for medical advice about side||
6333|132|S|effects. You may report side effects to Health Canada at||
6333|133|S|1-866-234-2345.||
6333|134|B|||
6333|135|P|PRECAUTIONS:  Before using beclomethasone, tell your doctor or||
6333|136|P|pharmacist if you are allergic to it; or if you have any other||
6333|137|P|allergies. This product may contain inactive ingredients, which||
6333|138|P|can cause allergic reactions or other problems. Talk to your||
6333|139|P|pharmacist for more details.||
6333|140|P|   Before using this medication, tell your doctor or pharmacist||
6333|141|P|your medical history, especially of: eye disease (such as||
6333|142|P|cataracts, glaucoma), liver disease, thyroid problems, diabetes,||
6333|143|P|stomach/intestinal problems (such as diverticulitis, ulcer), bone||
6333|144|P|loss (osteoporosis), current/past infections (such as||
6333|145|P|tuberculosis, positive tuberculosis test, herpes, fungal),||
6333|146|P|bleeding problems, mental/mood conditions (such as psychosis,||
6333|147|P|anxiety, depression).||
6333|148|P|   If you have switched from a corticosteroid taken by mouth||
6333|149|P|(such as prednisone tablets) to this inhaler within the past 12||
6333|150|P|months, or if you have been using this product in||
6333|151|P|higher-than-usual doses for a long time, it may be more difficult||
6333|152|P|for your body to respond to physical stress. Before having||
6333|153|P|surgery or emergency treatment, or if you get a serious||
6333|154|P|illness/injury, tell your doctor or dentist that you are using||
6333|155|P|this medication or have used a corticosteroid taken by mouth||
6333|156|P|within the past 12 months. Tell your doctor right away if you||
6333|157|P|develop unusual/extreme tiredness or weight loss. Carry a warning||
6333|158|P|card or medical ID bracelet that says you use (or have used)||
6333|159|P|corticosteroid medications.||
6333|160|P|   Before having surgery, tell your doctor or dentist about all||
6333|161|P|the products you use (including prescription drugs,||
6333|162|P|nonprescription drugs, and herbal products).||
6333|163|P|   This medication may mask signs of infection. It can make you||
6333|164|P|more likely to get infections or may make current infections||
6333|165|P|worse. Stay away from anyone who has an infection that may easily||
6333|166|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
6333|167|P|doctor if you have been exposed to an infection or for more||
6333|168|P|details.||
6333|169|P|   Tell your health care professional that you are using||
6333|170|P|beclomethasone before having any immunizations/vaccinations.||
6333|171|P|Avoid contact with people who have recently received live||
6333|172|P|vaccines (such as flu vaccine inhaled through the nose).||
6333|173|P|   This medication may temporarily slow down a child's growth if||
6333|174|P|used for a long time. However, poorly controlled asthma can also||
6333|175|P|slow down growth. See the doctor regularly so your child's height||
6333|176|P|can be checked.||
6333|177|P|   During pregnancy, this medication should be used only when||
6333|178|P|clearly needed. Discuss the risks and benefits with your doctor.||
6333|179|P|   It is unknown if this medication passes into breast milk.||
6333|180|P|Consult your doctor before breastfeeding.||
6333|181|B|||
6333|182|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6333|183|I|medications work or increase your risk for serious side effects.||
6333|184|I|This document does not contain all possible drug interactions.||
6333|185|I|Keep a list of all the products you use (including||
6333|186|I|prescription/nonprescription drugs and herbal products) and share||
6333|187|I|it with your doctor and pharmacist. Do not start, stop, or change||
6333|188|I|the dosage of any medicines without your doctor's approval.||
6333|189|I|   Some products that may interact with this drug include:||
6333|190|I|aldesleukin, desmopressin, other drugs that weaken the immune||
6333|191|I|system (such as azathioprine, cyclosporine, cancer chemotherapy),||
6333|192|I|mifepristone.||
6333|193|I|   This medication may interfere with certain lab tests (such as||
6333|194|I|skin tests), possibly causing false test results. Make sure lab||
6333|195|I|personnel and all your doctors know you use this drug.||
6333|196|B|||
6333|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6333|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6333|199|O|poison control center right away. US residents can call||
6333|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6333|201|B|||
6333|202|N|NOTES:  Do not share this medication with others.||
6333|203|N|   Lab and/or medical tests (such as cortisol levels, blood||
6333|204|N|counts, height/weight measurements, bone density tests, eye||
6333|205|N|exams) may be done while you are using this medication. Keep all||
6333|206|N|medical and lab appointments. Consult your doctor for more||
6333|207|N|details.||
6333|208|N|   Avoid triggers such as smoke, pollen, pet dander, dust, and||
6333|209|N|mold that can worsen breathing problems. Because the flu virus||
6333|210|N|can also worsen breathing problems, ask your doctor or pharmacist||
6333|211|N|if you should have a flu shot every year.||
6333|212|N|   This medication may cause bone loss (osteoporosis) in adults||
6333|213|N|when used for a long time. Lifestyle changes that may help reduce||
6333|214|N|the risk of bone problems include doing weight-bearing exercise,||
6333|215|N|stopping smoking, limiting alcohol, and getting enough calcium||
6333|216|N|and vitamin D. Talk to your doctor for more details.||
6333|217|B|||
6333|218|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
6333|219|D|If it is near the time of the next dose, skip the missed dose.||
6333|220|D|Use your next dose at the regular time. Do not double the dose to||
6333|221|D|catch up.||
6333|222|B|||
6333|223|R|STORAGE:  Store at room temperature. Do not use or store near||
6333|224|R|high heat or open flame. Because the canisters are under||
6333|225|R|pressure, do not puncture or burn. Keep all medications away from||
6333|226|R|children and pets.||
6333|227|R|   Do not flush medications down the toilet or pour them into a||
6333|228|R|drain unless instructed to do so. Properly discard this product||
6333|229|R|when it is expired or no longer needed. Consult your pharmacist||
6333|230|R|or local waste disposal company.||
6333|231|B|||
6333|232|M|MEDICAL ALERT:  Your condition can cause complications in a||
6333|233|M|medical emergency. For information about enrolling in MedicAlert,||
6333|234|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6333|235|B|||
6333|236|A|Information last revised September 2025.||
6333|237|A|Copyright(c) 2025 First Databank, Inc.||
6333|238|B|||
6341|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6341|002|Z|does NOT have all possible information about this product. This||
6341|003|Z|information does not assure that this product is safe, effective,||
6341|004|Z|or appropriate for you. This information is not individual||
6341|005|Z|medical advice and does not substitute for the advice of your||
6341|006|Z|health care professional. Always ask your health care||
6341|007|Z|professional for complete information about this product and your||
6341|008|Z|specific health needs.||
6341|009|B|||
6341|010|T|IBRITUMOMAB TIUXETAN - INJECTION||
6341|011|F|(EYE-bri-TOOM-oh-mab tye-UX-e-tan)||
6341|012|B|||
6341|013|C|COMMON BRAND NAME(S): Zevalin||
6341|014|B|||
6341|015|W|WARNING:  Rituximab, a medication that is used along with||
6341|016|W|ibritumomab tiuxetan, may rarely cause serious (sometimes fatal)||
6341|017|W|side effects, including severe breathing problems (such as||
6341|018|W|hypoxia, pulmonary infiltrates, acute respiratory distress||
6341|019|W|syndrome) or heart problems (such as heart attack, irregular||
6341|020|W|heartbeat, low blood pressure). These effects usually occur||
6341|021|W|within 30 minutes to 2 hours of receiving rituximab. The risk of||
6341|022|W|these effects is greater during your first treatment. Get medical||
6341|023|W|help right away if you have any of the following signs: trouble||
6341|024|W|breathing (such as shortness of breath, wheezing), itching,||
6341|025|W|swelling (especially of the throat/lips), severe dizziness,||
6341|026|W|fast/slow/irregular heartbeat, chest pain.||
6341|027|W|   This medication may cause very serious blood disorders||
6341|028|W|(decreased bone marrow function leading to low number of blood||
6341|029|W|cells such as red cells, white cells, and platelets). This effect||
6341|030|W|can cause anemia, decrease your body's ability to fight an||
6341|031|W|infection, or cause your body to bruise or bleed more easily.||
6341|032|W|Tell your doctor right away if you develop any of the following||
6341|033|W|symptoms: signs of infection (such as sore throat that doesn't go||
6341|034|W|away, fever, chills), easy bruising/bleeding, unusual tiredness,||
6341|035|W|fast/pounding heartbeat.||
6341|036|W|   Rarely, serious (sometimes fatal) skin reactions (such as||
6341|037|W|Stevens-Johnson syndrome) have occurred in patients receiving||
6341|038|W|this treatment program. These reactions can occur during||
6341|039|W|treatment or days to months after treatment is finished. Get||
6341|040|W|medical help right away if you develop a rash or pain/swelling of||
6341|041|W|the mouth/tongue/throat/eyes. If you have previously had a severe||
6341|042|W|skin reaction due to ibritumomab tiuxetan or the other||
6341|043|W|medication(s) used in the treatment program (such as rituximab,||
6341|044|W|yttrium), do not start this treatment program again. Consult your||
6341|045|W|doctor or pharmacist for more details.||
6341|046|B|||
6341|047|U|USES:  This medication is combined with a certain radioactive||
6341|048|U|substance (Yttrium-90) and used along with rituximab to treat a||
6341|049|U|certain type of cancer (B-cell non-Hodgkin's lymphoma) in||
6341|050|U|patients whose cancer has returned or has not responded to other||
6341|051|U|treatments. Ibritumomab tiuxetan and rituximab are known as||
6341|052|U|monoclonal antibodies. They work by killing certain blood and||
6341|053|U|cancer cells from your immune system (B cells). Yttrium-90 helps||
6341|054|U|kill the cancer cells.||
6341|055|B|||
6341|056|H|HOW TO USE:  This medication is given by injection into a vein by||
6341|057|H|a health care professional. The dosage is based on your medical||
6341|058|H|condition, weight, and response to treatment.||
6341|059|B|||
6341|060|S|SIDE EFFECTS:  See also Warning section.||
6341|061|S|   Nausea, vomiting, diarrhea, abdominal/stomach pain, cough,||
6341|062|S|dizziness, headache, flushing, or loss of appetite may occur. If||
6341|063|S|any of these effects last or get worse, tell your doctor or||
6341|064|S|pharmacist promptly.||
6341|065|S|   People using this medication may have serious side effects.||
6341|066|S|However, you have been prescribed this drug because your doctor||
6341|067|S|has judged that the benefit to you is greater than the risk of||
6341|068|S|side effects. Careful monitoring by your doctor may decrease your||
6341|069|S|risk.||
6341|070|S|   Tell your doctor right away if you have any serious side||
6341|071|S|effects, including: pain/swelling at injection site, swelling||
6341|072|S|ankles/feet, mental/mood changes (such as anxiety), black stools,||
6341|073|S|vomit that looks like coffee grounds, vaginal bleeding.||
6341|074|S|   Get medical help right away if you have any very serious side||
6341|075|S|effects, including: weakness on one side of the body, vision||
6341|076|S|problems, confusion, trouble speaking.||
6341|077|S|   This medication has rarely caused other types of cancer||
6341|078|S|(including myelodysplastic syndrome-MDS, acute myelogenous||
6341|079|S|leukemia-AML). This condition can lead to very serious blood||
6341|080|S|disorders. See also Warning section for symptoms.||
6341|081|S|   A very serious allergic reaction to this drug is rare.||
6341|082|S|However, get medical help right away if you notice any symptoms||
6341|083|S|of a serious allergic reaction, including: rash, itching/swelling||
6341|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6341|085|S|breathing.||
6341|086|S|   This is not a complete list of possible side effects. If you||
6341|087|S|notice other effects not listed above, contact your doctor or||
6341|088|S|pharmacist.||
6341|089|S|   In the US -||
6341|090|S|   Call your doctor for medical advice about side effects. You||
6341|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6341|092|S|www.fda.gov/medwatch.||
6341|093|S|   In Canada - Call your doctor for medical advice about side||
6341|094|S|effects. You may report side effects to Health Canada at||
6341|095|S|1-866-234-2345.||
6341|096|B|||
6341|097|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6341|098|P|pharmacist if you are allergic to it; or to other medications in||
6341|099|P|the treatment plan (rituximab, Yttrium-90); or if you have any||
6341|100|P|other allergies. This product may contain inactive ingredients,||
6341|101|P|which can cause allergic reactions or other problems. Talk to||
6341|102|P|your pharmacist for more details.||
6341|103|P|   Before using this medication, tell your doctor or pharmacist||
6341|104|P|your medical history, especially of: blood/bone marrow disorders||
6341|105|P|(such as neutropenia, thrombocytopenia), recent/current||
6341|106|P|infections.||
6341|107|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6341|108|P|can make you more dizzy. Do not drive, use machinery, or do||
6341|109|P|anything that needs alertness until you can do it safely. Limit||
6341|110|P|alcoholic beverages. Talk to your doctor if you are using||
6341|111|P|marijuana (cannabis).||
6341|112|P|   Before having surgery, tell your doctor or dentist about all||
6341|113|P|the products you use (including prescription drugs,||
6341|114|P|nonprescription drugs, and herbal products).||
6341|115|P|   Tell your health care professional that you are using||
6341|116|P|ibritumomab tiuxetan before having any||
6341|117|P|immunizations/vaccinations. Avoid contact with people who have||
6341|118|P|recently received live vaccines (such as flu vaccine inhaled||
6341|119|P|through the nose).||
6341|120|P|   Ibritumomab tiuxetan can make you more likely to get||
6341|121|P|infections or may make current infections worse. Stay away from||
6341|122|P|anyone who has an infection that may easily spread (such as||
6341|123|P|chickenpox, COVID-19, measles, flu). Talk to your doctor if you||
6341|124|P|have been exposed to an infection or for more details.||
6341|125|P|   To lower your risk of getting cut, bruised, or injured, use||
6341|126|P|caution with sharp objects like razors and nail cutters, and||
6341|127|P|avoid activities such as contact sports.||
6341|128|P|   This medication is made from human blood. Even though the||
6341|129|P|blood is carefully tested, and this medication goes through a||
6341|130|P|special manufacturing process, there is an extremely small chance||
6341|131|P|that you may get infections from the medication (for example,||
6341|132|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
6341|133|P|more information.||
6341|134|P|   Tell your doctor if you are pregnant or plan to become||
6341|135|P|pregnant. You should not become pregnant while using ibritumomab||
6341|136|P|tiuxetan. Ibritumomab tiuxetan may harm an unborn baby. Your||
6341|137|P|doctor should order a pregnancy test before you start this||
6341|138|P|medication. Men and women using this medication should ask about||
6341|139|P|reliable forms of birth control during treatment and for 12||
6341|140|P|months after the last dose. If you or your partner becomes||
6341|141|P|pregnant, talk to your doctor right away about the risks and||
6341|142|P|benefits of this medication.||
6341|143|P|   It is unknown if this drug passes into breast milk. Because of||
6341|144|P|the possible risk to the infant, breastfeeding is not recommended||
6341|145|P|while using this medication and for 6 months after the last dose.||
6341|146|P|Consult your doctor before breastfeeding.||
6341|147|B|||
6341|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6341|149|I|medications work or increase your risk for serious side effects.||
6341|150|I|This document does not contain all possible drug interactions.||
6341|151|I|Keep a list of all the products you use (including||
6341|152|I|prescription/nonprescription drugs and herbal products) and share||
6341|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
6341|154|I|the dosage of any medicines without your doctor's approval.||
6341|155|I|   Some products that may interact with this drug include: drugs||
6341|156|I|that affect the immune system (for example, azathioprine,||
6341|157|I|cyclosporine, corticosteroids such as prednisone), other drugs||
6341|158|I|that can cause bleeding/bruising (including antiplatelet drugs||
6341|159|I|such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood||
6341|160|I|thinners" such as warfarin/dabigatran).||
6341|161|I|   Aspirin can increase the risk of bleeding when used with this||
6341|162|I|medication. However, if your doctor has told you to take low-dose||
6341|163|I|aspirin to prevent heart attack or stroke (usually 81-162||
6341|164|I|milligrams a day), you should keep taking the aspirin unless your||
6341|165|I|doctor tells you not to. Ask your doctor or pharmacist for more||
6341|166|I|details.||
6341|167|B|||
6341|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6341|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6341|170|O|poison control center right away. US residents can call||
6341|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6341|172|O|Symptoms of overdose may include: signs of infection (such as||
6341|173|O|sore throat that doesn't go away, fever), easy bruising/bleeding,||
6341|174|O|unusual tiredness, fast/pounding heartbeat.||
6341|175|B|||
6341|176|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
6341|177|N|platelets, blood pressure) should be done while you are using||
6341|178|N|this medication. Keep all medical and lab appointments. Consult||
6341|179|N|your doctor for more details.||
6341|180|B|||
6341|181|D|MISSED DOSE:  It is important to get each dose of this medication||
6341|182|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
6341|183|D|right away for a new dosing schedule.||
6341|184|B|||
6341|185|R|STORAGE:  Not applicable. This medication is given in a clinic||
6341|186|R|and will not be stored at home.||
6341|187|B|||
6341|188|M|MEDICAL ALERT:  Your condition can cause complications in a||
6341|189|M|medical emergency. For information about enrolling in MedicAlert,||
6341|190|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
6341|191|B|||
6341|192|A|Information last revised May 2025.||
6341|193|A|Copyright(c) 2025 First Databank, Inc.||
6341|194|B|||
6343|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6343|002|Z|does NOT have all possible information about this product. This||
6343|003|Z|information does not assure that this product is safe, effective,||
6343|004|Z|or appropriate for you. This information is not individual||
6343|005|Z|medical advice and does not substitute for the advice of your||
6343|006|Z|health care professional. Always ask your health care||
6343|007|Z|professional for complete information about this product and your||
6343|008|Z|specific health needs.||
6343|009|B|||
6343|010|T|HEME IRON POLYPEPTIDE - ORAL||
6343|011|F|(heem EYE-urn POL-ee-PEP-tide)||
6343|012|B|||
6343|013|C|COMMON BRAND NAME(S): Proferrin||
6343|014|B|||
6343|015|W|WARNING:  Accidental overdose of iron-containing products is a||
6343|016|W|leading cause of fatal poisoning in children younger than 6||
6343|017|W|years. Keep this product out of reach of children. If overdose||
6343|018|W|does occur, get medical help right away or call a poison control||
6343|019|W|center.||
6343|020|B|||
6343|021|U|USES:  This product is an iron supplement used to prevent or||
6343|022|U|treat low levels of iron in the blood (such as those caused by||
6343|023|U|anemia or pregnancy). Iron is an important mineral that the body||
6343|024|U|needs to produce red blood cells and keep you in good health.||
6343|025|B|||
6343|026|H|HOW TO USE:  Take this product by mouth with or without food as||
6343|027|H|directed. Follow all directions on the product package. If you||
6343|028|H|have any questions, ask your doctor or pharmacist. Take this||
6343|029|H|product with a full glass of water (8 ounces or 240 milliliters)||
6343|030|H|unless your doctor directs you otherwise. Do not lie down for at||
6343|031|H|least 10 minutes after taking this product.||
6343|032|H|   The dosage is based on your medical condition and response to||
6343|033|H|treatment.||
6343|034|H|   Use this product regularly to get the most benefit from it. To||
6343|035|H|help you remember, take it at the same time(s) each day.||
6343|036|B|||
6343|037|S|SIDE EFFECTS:  Constipation, diarrhea, nausea, upset stomach and||
6343|038|S|stomach/abdominal cramping may occur. If any of these effects||
6343|039|S|last or get worse, tell your doctor or pharmacist promptly.||
6343|040|S|   Iron may cause your stools to turn black, an effect that is||
6343|041|S|not harmful.||
6343|042|S|   If your doctor has directed you to use this medication,||
6343|043|S|remember that your doctor has judged that the benefit to you is||
6343|044|S|greater than the risk of side effects. Many people using this||
6343|045|S|medication do not have serious side effects.||
6343|046|S|   A very serious allergic reaction to this product is rare.||
6343|047|S|However, get medical help right away if you notice any symptoms||
6343|048|S|of a serious allergic reaction, including: rash, itching/swelling||
6343|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6343|050|S|breathing.||
6343|051|S|   This is not a complete list of possible side effects. If you||
6343|052|S|notice other effects not listed above, contact your doctor or||
6343|053|S|pharmacist.||
6343|054|S|   In the US -||
6343|055|S|   Call your doctor for medical advice about side effects. You||
6343|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6343|057|S|www.fda.gov/medwatch.||
6343|058|S|   In Canada - Call your doctor for medical advice about side||
6343|059|S|effects. You may report side effects to Health Canada at||
6343|060|S|1-866-234-2345.||
6343|061|B|||
6343|062|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
6343|063|P|pharmacist if you are allergic to it; or to cow products; or if||
6343|064|P|you have any other allergies. This product may contain inactive||
6343|065|P|ingredients, which can cause allergic reactions or other||
6343|066|P|problems. Talk to your pharmacist for more details.||
6343|067|P|   If you have any of the following health problems, consult your||
6343|068|P|doctor or pharmacist before using this product: an iron overload||
6343|069|P|disorder (such as hemochromatosis), other types of anemia (such||
6343|070|P|as hemolytic), repeated blood transfusions, stomach/intestinal||
6343|071|P|problems (such as ulcer, colitis).||
6343|072|P|   This product is made from the red blood cells of cows. If you||
6343|073|P|prefer not to use products made from animal sources, consult your||
6343|074|P|doctor about other iron-containing products.||
6343|075|P|   Before having surgery, tell your doctor or dentist about all||
6343|076|P|the products you use (including prescription drugs,||
6343|077|P|nonprescription drugs, and herbal products).||
6343|078|P|   Tell your doctor if you are pregnant before using this||
6343|079|P|product.||
6343|080|P|   Iron passes into breast milk. Consult your doctor before||
6343|081|P|breastfeeding.||
6343|082|B|||
6343|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6343|084|I|medications work or increase your risk for serious side effects.||
6343|085|I|This document does not contain all possible drug interactions.||
6343|086|I|Keep a list of all the products you use (including||
6343|087|I|prescription/nonprescription drugs and herbal products) and share||
6343|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
6343|089|I|the dosage of any medicines without your doctor's approval.||
6343|090|I|   Some drugs that may interact with this product include:||
6343|091|I|antacids.||
6343|092|I|   This product can decrease the absorption of certain drugs,||
6343|093|I|especially if you take them around the same time. These drugs||
6343|094|I|include bisphosphonates (such as alendronate), levodopa,||
6343|095|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
6343|096|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
6343|097|I|minocycline), thyroid medications (such as levothyroxine), among||
6343|098|I|others. Ask your doctor or pharmacist how long you should wait||
6343|099|I|between doses of this product and your other medications and to||
6343|100|I|find a dosing schedule that works for all your medications.||
6343|101|I|   This product may interfere with certain lab tests (such as||
6343|102|I|testing for blood in stool), possibly causing false test results.||
6343|103|I|Make sure lab personnel and all your doctors know you use this||
6343|104|I|product.||
6343|105|B|||
6343|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6343|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6343|108|O|poison control center right away. US residents can call||
6343|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6343|110|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
6343|111|O|diarrhea, weakness.||
6343|112|B|||
6343|113|N|NOTES:  Do not share this product with others.||
6343|114|N|   This product is not a substitute for a proper diet. It is||
6343|115|N|important to maintain a well-balanced diet. Foods rich in iron||
6343|116|N|include red meats (especially liver), fish, beans, dried fruit,||
6343|117|N|and iron-fortified/enriched cereals and bread.||
6343|118|N|   Lab and/or medical tests (such as iron levels,||
6343|119|N|hematocrit/hemoglobin blood test) may be done while you are||
6343|120|N|taking this product. Keep all medical and lab appointments.||
6343|121|N|Consult your doctor for more details.||
6343|122|B|||
6343|123|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6343|124|D|remember. If it is near the time of the next dose, skip the||
6343|125|D|missed dose. Take your next dose at the regular time. Do not||
6343|126|D|double the dose to catch up.||
6343|127|B|||
6343|128|R|STORAGE:  Store at room temperature away from light and moisture.||
6343|129|R|Do not store in the bathroom. Keep all medications away from||
6343|130|R|children and pets.||
6343|131|R|   Do not flush medications down the toilet or pour them into a||
6343|132|R|drain unless instructed to do so. Properly discard this product||
6343|133|R|when it is expired or no longer needed. Consult your pharmacist||
6343|134|R|or local waste disposal company.||
6343|135|B|||
6343|136|A|Information last revised October 2025.||
6343|137|A|Copyright(c) 2025 First Databank, Inc.||
6343|138|B|||
6352|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6352|002|Z|does NOT have all possible information about this product. This||
6352|003|Z|information does not assure that this product is safe, effective,||
6352|004|Z|or appropriate for you. This information is not individual||
6352|005|Z|medical advice and does not substitute for the advice of your||
6352|006|Z|health care professional. Always ask your health care||
6352|007|Z|professional for complete information about this product and your||
6352|008|Z|specific health needs.||
6352|009|B|||
6352|010|T|ACETAMINOPHEN/CODEINE - ORAL||
6352|011|F|(a-SEET-a-MIN-oh-fen/KOE-deen)||
6352|012|B|||
6352|013|C|COMMON BRAND NAME(S): Tylenol-Codeine, Vopac||
6352|014|B|||
6352|015|W|WARNING:  Codeine has a risk for abuse and addiction, which can||
6352|016|W|lead to overdose and death. Codeine may also cause severe,||
6352|017|W|possibly fatal, breathing problems. To lower your risk, your||
6352|018|W|doctor should have you take the smallest dose of codeine that||
6352|019|W|works, and take it for the shortest possible time. See also How||
6352|020|W|to Use section for more information about addiction.||
6352|021|W|   Ask your doctor or pharmacist if you should have medication||
6352|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
6352|023|W|Teach your family or household members about the signs of an||
6352|024|W|opioid overdose and how to treat it.||
6352|025|W|   The risk for severe breathing problems is higher when you||
6352|026|W|start this medication and after a dose increase, or if you take||
6352|027|W|the wrong dose/strength. Taking this medication with alcohol or||
6352|028|W|other drugs that can cause drowsiness or breathing problems may||
6352|029|W|cause very serious side effects, including death. Also, other||
6352|030|W|medications can affect the removal of codeine from your body,||
6352|031|W|which may affect how codeine works. Be sure you know how to take||
6352|032|W|this medication and what other drugs you should avoid taking with||
6352|033|W|it. See also Drug Interactions section. Get medical help right||
6352|034|W|away if any of these very serious side effects occur:||
6352|035|W|slow/shallow breathing, unusual lightheadedness, severe||
6352|036|W|drowsiness/dizziness, difficulty waking up.||
6352|037|W|   Keep this medicine in a safe place to prevent theft, misuse,||
6352|038|W|or abuse. If someone accidentally swallows this drug, get medical||
6352|039|W|help right away.||
6352|040|W|   One ingredient in this product is acetaminophen. Taking too||
6352|041|W|much acetaminophen may cause serious (possibly fatal) liver||
6352|042|W|disease. Adults should not take more than 4000 milligrams (4||
6352|043|W|grams) of acetaminophen a day. People with liver problems and||
6352|044|W|children should take less acetaminophen. Ask your doctor or||
6352|045|W|pharmacist how much acetaminophen is safe to take.||
6352|046|W|   Do not use with any other drug containing acetaminophen||
6352|047|W|without asking your doctor or pharmacist first. Acetaminophen is||
6352|048|W|in many nonprescription and prescription medications (such as||
6352|049|W|pain/fever drugs or cough-and-cold products). Check the labels on||
6352|050|W|all your medicines to see if they contain acetaminophen, and ask||
6352|051|W|your pharmacist if you are unsure.||
6352|052|W|   Get medical help right away if you take too much acetaminophen||
6352|053|W|(overdose), even if you feel well. Overdose symptoms may include||
6352|054|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
6352|055|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
6352|056|W|   Daily alcohol use, especially when combined with||
6352|057|W|acetaminophen, may damage your liver. Avoid alcohol.||
6352|058|W|   Before using this medication, women of childbearing age should||
6352|059|W|talk with their doctor(s) about the risks and benefits. Tell your||
6352|060|W|doctor if you are pregnant or if you plan to become pregnant.||
6352|061|W|During pregnancy, this medication should be used only when||
6352|062|W|clearly needed. It may slightly increase the risk of birth||
6352|063|W|defects if used during the first two months of pregnancy. Also,||
6352|064|W|using it for a long time or in high doses near the expected||
6352|065|W|delivery date may harm the unborn baby. To lessen the risk, take||
6352|066|W|the smallest effective dose for the shortest possible time.||
6352|067|W|Babies born to mothers who use this drug for a long time may||
6352|068|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
6352|069|W|doctor right away if you notice any symptoms in your newborn baby||
6352|070|W|such as crying that doesn't stop, slow/shallow breathing,||
6352|071|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
6352|072|W|difficulty gaining weight.||
6352|073|W|   Children younger than 18 years should not use products that||
6352|074|W|contain codeine. Some children are more sensitive to codeine and||
6352|075|W|have had very serious (rarely fatal) breathing problems such as||
6352|076|W|slow/shallow breathing (see also Side Effects section). The risk||
6352|077|W|is greater in children who are obese or have breathing problems,||
6352|078|W|or after certain surgeries (including tonsil/adenoid removal).||
6352|079|W|Talk with your doctor or pharmacist about the risks and benefits||
6352|080|W|of this medication.||
6352|081|B|||
6352|082|U|USES:  See also Warning section.||
6352|083|U|   This combination medication is used to help relieve mild to||
6352|084|U|moderate pain. It contains an opioid pain reliever (codeine) and||
6352|085|U|a non-opioid pain reliever (acetaminophen). Codeine works in the||
6352|086|U|brain to change how your body feels and responds to pain.||
6352|087|U|Acetaminophen can also reduce a fever.||
6352|088|B|||
6352|089|H|HOW TO USE:  See also Warning section.||
6352|090|H|   Read the Medication Guide provided by your pharmacist before||
6352|091|H|you start taking acetaminophen/codeine and each time you get a||
6352|092|H|refill. If you have any questions, ask your doctor or pharmacist.||
6352|093|H|   Take this medication by mouth as directed by your doctor. You||
6352|094|H|may take this drug with or without food. If you have nausea, it||
6352|095|H|may help to take this drug with food. Ask your doctor or||
6352|096|H|pharmacist about other ways to decrease nausea (such as lying||
6352|097|H|down for 1 to 2 hours with as little head movement as possible).||
6352|098|H|   If you are using a liquid form of this medication, use a||
6352|099|H|medication measuring device to carefully measure the prescribed||
6352|100|H|dose. Do not use a household spoon because you may not get the||
6352|101|H|correct dose. If you are taking the suspension, shake the bottle||
6352|102|H|well before each dose.||
6352|103|H|   The dosage is based on your medical condition and response to||
6352|104|H|treatment. Do not increase your dose, take the medication more||
6352|105|H|often, or take it for a longer time than prescribed. Properly||
6352|106|H|stop the medication when so directed.||
6352|107|H|   Pain medications work best if they are used as the first signs||
6352|108|H|of pain occur. If you wait until the pain has worsened, the||
6352|109|H|medication may not work as well.||
6352|110|H|   If you have ongoing pain (such as due to cancer), your doctor||
6352|111|H|may direct you to also take long-acting opioid medications. In||
6352|112|H|that case, this medication might be used for sudden||
6352|113|H|(breakthrough) pain only as needed. Other pain relievers (such as||
6352|114|H|naproxen, ibuprofen) may also be prescribed with this medication.||
6352|115|H|Ask your doctor or pharmacist about using this product safely||
6352|116|H|with other drugs.||
6352|117|H|   Suddenly stopping this medication may cause withdrawal,||
6352|118|H|especially if you have used it for a long time or in high doses.||
6352|119|H|To prevent withdrawal, your doctor may lower your dose slowly.||
6352|120|H|Tell your doctor or pharmacist right away if you have any||
6352|121|H|withdrawal symptoms such as restlessness, mental/mood changes||
6352|122|H|(including anxiety, trouble sleeping, thoughts of suicide),||
6352|123|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
6352|124|H|aches, or sudden changes in behavior.||
6352|125|H|   When this medication is used for a long time, it may not work||
6352|126|H|as well. Talk with your doctor if this medication stops working||
6352|127|H|well.||
6352|128|H|   Though it helps many people, this medication may sometimes||
6352|129|H|cause addiction. This risk may be higher if you have a||
6352|130|H|mental/mood disorder or a substance use disorder (such as overuse||
6352|131|H|of or addiction to drugs/alcohol). Take this medication exactly||
6352|132|H|as prescribed to lower the risk of addiction. Ask your doctor or||
6352|133|H|pharmacist for more details.||
6352|134|H|   Tell your doctor if your pain does not get better or if it||
6352|135|H|gets worse, or if you have any new pain.||
6352|136|B|||
6352|137|S|SIDE EFFECTS:  See also Warning section.||
6352|138|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
6352|139|S|drowsiness may occur. Some of these side effects may decrease||
6352|140|S|after you have been using this medication for a while. If any of||
6352|141|S|these effects last or get worse, tell your doctor or pharmacist||
6352|142|S|promptly.||
6352|143|S|   To prevent constipation, eat dietary fiber, drink enough||
6352|144|S|water, and exercise. You may also need to take a laxative. Ask||
6352|145|S|your pharmacist which type of laxative is right for you.||
6352|146|S|   To reduce the risk of dizziness and lightheadedness, get up||
6352|147|S|slowly when rising from a sitting or lying position.||
6352|148|S|   Remember that this medication has been prescribed because your||
6352|149|S|doctor has judged that the benefit to you is greater than the||
6352|150|S|risk of side effects. Many people using this medication do not||
6352|151|S|have serious side effects.||
6352|152|S|   Tell your doctor right away if you have any serious side||
6352|153|S|effects, including: interrupted breathing during sleep (sleep||
6352|154|S|apnea), mental/mood changes (such as agitation, depression,||
6352|155|S|hallucinations), severe stomach/abdominal pain, difficulty||
6352|156|S|urinating, fast/slow heartbeat, vision changes, signs of your||
6352|157|S|adrenal glands not working well (such as loss of appetite,||
6352|158|S|unusual tiredness, weight loss), trouble swallowing.||
6352|159|S|   Get medical help right away if you have any very serious side||
6352|160|S|effects, including: fainting, seizure.||
6352|161|S|   Codeine is changed into a strong opioid drug (morphine) in||
6352|162|S|your body. In some people, this change happens faster and more||
6352|163|S|completely than usual, which increases the risk of very serious||
6352|164|S|side effects. Get medical help right away if you notice any of||
6352|165|S|the following: slow/shallow breathing, severe||
6352|166|S|drowsiness/difficulty waking up, confusion.||
6352|167|S|   A very serious allergic reaction to this drug is rare.||
6352|168|S|However, get medical help right away if you notice any symptoms||
6352|169|S|of a serious allergic reaction, including: rash, itching/swelling||
6352|170|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6352|171|S|breathing.||
6352|172|S|   This is not a complete list of possible side effects. If you||
6352|173|S|notice other effects not listed above, contact your doctor or||
6352|174|S|pharmacist.||
6352|175|S|   In the US -||
6352|176|S|   Call your doctor for medical advice about side effects. You||
6352|177|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6352|178|S|www.fda.gov/medwatch.||
6352|179|S|   In Canada - Call your doctor for medical advice about side||
6352|180|S|effects. You may report side effects to Health Canada at||
6352|181|S|1-866-234-2345.||
6352|182|B|||
6352|183|P|PRECAUTIONS:  See also Warning section.||
6352|184|P|   Before taking this product, tell your doctor or pharmacist if||
6352|185|P|you are allergic to acetaminophen or codeine; or to other opioid||
6352|186|P|pain medications (such as morphine); or if you have any other||
6352|187|P|allergies. This product may contain inactive ingredients (such as||
6352|188|P|metabisulfite), which can cause allergic reactions or other||
6352|189|P|problems. Talk to your pharmacist for more details.||
6352|190|P|   Before using this medication, tell your doctor or pharmacist||
6352|191|P|your medical history, especially of: brain disorders (such as||
6352|192|P|head injury, tumor, seizures), breathing problems (such as||
6352|193|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
6352|194|P|kidney disease, liver disease, mental/mood disorders (such as||
6352|195|P|confusion, depression), personal or family history of a substance||
6352|196|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
6352|197|P|obesity, stomach/intestinal problems (such as blockage,||
6352|198|P|constipation, diarrhea due to infection, paralytic ileus),||
6352|199|P|difficulty urinating (such as due to enlarged prostate),||
6352|200|P|gallbladder disease, disease of the pancreas (pancreatitis).||
6352|201|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6352|202|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6352|203|P|machinery, or do anything that needs alertness until you can do||
6352|204|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6352|205|P|are using marijuana (cannabis).||
6352|206|P|   Liquid products may contain sugar and alcohol. Caution is||
6352|207|P|advised if you have diabetes, alcohol dependence, liver disease,||
6352|208|P|or any other condition that requires you to limit/avoid these||
6352|209|P|substances in your diet. Ask your doctor or pharmacist about||
6352|210|P|using this product safely.||
6352|211|P|   Before having surgery, tell your doctor or dentist about all||
6352|212|P|the products you use (including prescription drugs,||
6352|213|P|nonprescription drugs, and herbal products).||
6352|214|P|   Older adults may be more sensitive to the side effects of this||
6352|215|P|drug, especially confusion, dizziness, drowsiness, and||
6352|216|P|slow/shallow breathing.||
6352|217|P|   During pregnancy, this medication should be used only when||
6352|218|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
6352|219|P|benefits with your doctor.||
6352|220|P|   This medication passes into breast milk and may have||
6352|221|P|undesirable effects on a nursing infant, such as unusual||
6352|222|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
6352|223|P|limpness. Consult your doctor before breastfeeding.||
6352|224|B|||
6352|225|I|DRUG INTERACTIONS:  See also Warning section.||
6352|226|I|   Drug interactions may change how your medications work or||
6352|227|I|increase your risk for serious side effects. This document does||
6352|228|I|not contain all possible drug interactions. Keep a list of all||
6352|229|I|the products you use (including prescription/nonprescription||
6352|230|I|drugs and herbal products) and share it with your doctor and||
6352|231|I|pharmacist. Do not start, stop, or change the dosage of any||
6352|232|I|medicines without your doctor's approval.||
6352|233|I|   Some products that may interact with this drug include:||
6352|234|I|certain pain medications (mixed opioid agonist-antagonists such||
6352|235|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
6352|236|I|samidorphan.||
6352|237|I|   The risk of serious side effects (such as slow/shallow||
6352|238|I|breathing, severe drowsiness/dizziness) may be increased if this||
6352|239|I|medication is taken with other products that may also cause||
6352|240|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
6352|241|I|if you are taking other products such as other opioid pain or||
6352|242|I|cough relievers (such as morphine, hydrocodone), alcohol,||
6352|243|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
6352|244|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
6352|245|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
6352|246|I|cetirizine, diphenhydramine).||
6352|247|I|   Check the labels on all your medicines (such as allergy or||
6352|248|I|cough-and-cold products) because they may contain ingredients||
6352|249|I|that cause drowsiness. Ask your pharmacist about using those||
6352|250|I|products safely.||
6352|251|I|   Other medications can affect the removal of||
6352|252|I|acetaminophen/codeine from your body, which may affect how||
6352|253|I|acetaminophen/codeine works. Examples include azole antifungals||
6352|254|I|(such as ketoconazole), bupropion, fluoxetine, macrolide||
6352|255|I|antibiotics (such as erythromycin), levoketoconazole, paroxetine,||
6352|256|I|quinidine, rifamycins (such as rifabutin, rifampin), ritonavir,||
6352|257|I|certain drugs used to treat seizures (such as carbamazepine,||
6352|258|I|phenytoin), among others.||
6352|259|I|   This medication may interfere with certain lab tests (such as||
6352|260|I|amylase/lipase levels), possibly causing false test results. Make||
6352|261|I|sure lab personnel and all your doctors know you use this drug.||
6352|262|B|||
6352|263|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6352|264|O|as passing out or trouble breathing, give them naloxone or||
6352|265|O|nalmefene if available, then call 911. If the person is awake and||
6352|266|O|has no symptoms, call a poison control center right away. US||
6352|267|O|residents can call 1-800-222-1222. Canada residents can call||
6352|268|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
6352|269|O|breathing, nausea, vomiting, loss of appetite, sweating,||
6352|270|O|stomach/abdominal pain, slow heartbeat, extreme tiredness,||
6352|271|O|yellowing eyes/skin, dark urine, coma.||
6352|272|B|||
6352|273|N|NOTES:  Do not share this medication with others. Sharing it is||
6352|274|N|against the law.||
6352|275|N|   This medication has been prescribed for your current condition||
6352|276|N|only. Do not use it later for another condition unless your||
6352|277|N|doctor directs you to do so. A different medication may be||
6352|278|N|necessary in that case.||
6352|279|B|||
6352|280|D|MISSED DOSE:  If you are taking this medication on a regular||
6352|281|D|schedule and you miss a dose, take it as soon as you remember. If||
6352|282|D|it is near the time of the next dose, skip the missed dose. Take||
6352|283|D|your next dose at the regular time. Do not double the dose to||
6352|284|D|catch up.||
6352|285|B|||
6352|286|R|STORAGE:  Store at room temperature away from light and moisture.||
6352|287|R|Different brands of this medication have different storage needs.||
6352|288|R|Check the product package for instructions on how to store your||
6352|289|R|brand, or ask your pharmacist. Keep all medications away from||
6352|290|R|children and pets.||
6352|291|R|   Do not flush medications down the toilet or pour them into a||
6352|292|R|drain unless instructed to do so. Properly discard this product||
6352|293|R|when it is expired or no longer needed. Consult your pharmacist||
6352|294|R|or local waste disposal company.||
6352|295|B|||
6352|296|A|Information last revised August 2025.||
6352|297|A|Copyright(c) 2025 First Databank, Inc.||
6352|298|B|||
6353|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6353|002|Z|does NOT have all possible information about this product. This||
6353|003|Z|information does not assure that this product is safe, effective,||
6353|004|Z|or appropriate for you. This information is not individual||
6353|005|Z|medical advice and does not substitute for the advice of your||
6353|006|Z|health care professional. Always ask your health care||
6353|007|Z|professional for complete information about this product and your||
6353|008|Z|specific health needs.||
6353|009|B|||
6353|010|T|METOPROLOL - ORAL||
6353|011|F|(MET-oh-PROE-lol)||
6353|012|B|||
6353|013|C|COMMON BRAND NAME(S): Lopressor||
6353|014|B|||
6353|015|W|WARNING:  Do not stop taking this medication without consulting||
6353|016|W|your doctor. Some conditions may become worse when you suddenly||
6353|017|W|stop this drug. Some people who have suddenly stopped taking||
6353|018|W|similar drugs have had chest pain, heart attack, and irregular||
6353|019|W|heartbeat. If your doctor decides you should no longer use this||
6353|020|W|drug, your doctor may direct you to gradually decrease your dose||
6353|021|W|over 1 to 2 weeks.||
6353|022|W|   When gradually stopping this medication, it is recommended||
6353|023|W|that you temporarily limit physical activity to decrease strain||
6353|024|W|on the heart. Get medical help right away if you develop chest||
6353|025|W|pain/tightness/pressure, chest pain spreading to the||
6353|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
6353|027|W|fast/irregular heartbeat.||
6353|028|B|||
6353|029|U|USES:  Metoprolol is used with or without other medications to||
6353|030|U|treat high blood pressure (hypertension). Lowering high blood||
6353|031|U|pressure helps prevent strokes, heart attacks, and kidney||
6353|032|U|problems. This medication is also used to treat chest pain||
6353|033|U|(angina) and to improve survival after a heart attack.||
6353|034|U|   Metoprolol belongs to a class of drugs known as beta blockers.||
6353|035|U|It works by blocking the action of certain natural chemicals in||
6353|036|U|your body, such as epinephrine, on the heart and blood vessels.||
6353|037|U|This effect lowers the heart rate, blood pressure, and strain on||
6353|038|U|the heart.||
6353|039|B|||
6353|040|V|OTHER USES:  This section contains uses of this drug that are not||
6353|041|V|listed in the approved professional labeling for the drug but||
6353|042|V|that may be prescribed by your health care professional. Use this||
6353|043|V|drug for a condition that is listed in this section only if it||
6353|044|V|has been so prescribed by your health care professional.||
6353|045|V|   This drug may also be used for irregular heartbeats or||
6353|046|V|tremors. It may also be used to reduce the risk of migraine||
6353|047|V|headaches.||
6353|048|B|||
6353|049|H|HOW TO USE:  See also Warning section.||
6353|050|H|   Take this medication by mouth with or right after a meal as||
6353|051|H|directed by your doctor, usually 1 to 3 times a day. The dosage||
6353|052|H|is based on your medical condition and response to treatment.||
6353|053|H|   If you are taking the liquid form of this medication, read the||
6353|054|H|Instructions for Use before you start taking this medication.||
6353|055|H|Carefully measure the dose using the oral syringe that comes with||
6353|056|H|the medication. Do not use a household spoon because you may not||
6353|057|H|get the correct dose. Rinse the syringe with water after each||
6353|058|H|use.||
6353|059|H|   To reduce your risk of side effects, your doctor may direct||
6353|060|H|you to start this medication at a low dose and gradually increase||
6353|061|H|your dose. Follow your doctor's instructions carefully.||
6353|062|H|   Use this medication regularly to get the most benefit from it.||
6353|063|H|To help you remember, take it at the same time(s) each day. Do||
6353|064|H|not suddenly stop taking this medication without consulting your||
6353|065|H|doctor. Your condition may become worse when the drug is suddenly||
6353|066|H|stopped.||
6353|067|H|   For the treatment of high blood pressure, it may take several||
6353|068|H|weeks before you get the full benefit of this drug. Keep taking||
6353|069|H|this medication even if you feel well. Most people with high||
6353|070|H|blood pressure do not feel sick.||
6353|071|H|   To prevent chest pain, a second heart attack, or migraine||
6353|072|H|headaches, it is very important to take this medication regularly||
6353|073|H|as prescribed. This drug should not be used to treat chest pain||
6353|074|H|or migraines when they occur. Use other medications to relieve||
6353|075|H|sudden attacks as directed by your doctor (for example,||
6353|076|H|nitroglycerin tablets placed under the tongue for chest pain,||
6353|077|H|"triptan" drugs such as sumatriptan for migraines). Consult your||
6353|078|H|doctor or pharmacist for details.||
6353|079|H|   Tell your doctor if your condition does not get better or if||
6353|080|H|it gets worse (for example, your blood pressure readings remain||
6353|081|H|high or increase, your chest pain or migraines occur more often).||
6353|082|B|||
6353|083|S|SIDE EFFECTS:  See also Warning section.||
6353|084|S|   Drowsiness, dizziness, tiredness, diarrhea, and slow heartbeat||
6353|085|S|may occur. Decreased sexual ability has been reported rarely. If||
6353|086|S|any of these effects last or get worse, tell your doctor or||
6353|087|S|pharmacist promptly.||
6353|088|S|   To reduce the risk of dizziness and lightheadedness, get up||
6353|089|S|slowly when rising from a sitting or lying position.||
6353|090|S|   This drug may reduce blood flow to your hands and feet,||
6353|091|S|causing them to feel cold. Smoking may worsen this effect. Dress||
6353|092|S|warmly and avoid tobacco use.||
6353|093|S|   Remember that this medication has been prescribed because your||
6353|094|S|doctor has judged that the benefit to you is greater than the||
6353|095|S|risk of side effects. Many people using this medication do not||
6353|096|S|have serious side effects.||
6353|097|S|   Tell your doctor right away if you have any serious side||
6353|098|S|effects, including: very slow heartbeat, fainting, blue||
6353|099|S|fingers/toes, new or worsening symptoms of heart failure (such as||
6353|100|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
6353|101|S|unusual/sudden weight gain), mental/mood changes (such as||
6353|102|S|confusion, mood swings, depression).||
6353|103|S|   A very serious allergic reaction to this drug is rare.||
6353|104|S|However, get medical help right away if you notice any symptoms||
6353|105|S|of a serious allergic reaction, including: rash, itching/swelling||
6353|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6353|107|S|breathing.||
6353|108|S|   This is not a complete list of possible side effects. If you||
6353|109|S|notice other effects not listed above, contact your doctor or||
6353|110|S|pharmacist.||
6353|111|S|   In the US -||
6353|112|S|   Call your doctor for medical advice about side effects. You||
6353|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6353|114|S|www.fda.gov/medwatch.||
6353|115|S|   In Canada - Call your doctor for medical advice about side||
6353|116|S|effects. You may report side effects to Health Canada at||
6353|117|S|1-866-234-2345.||
6353|118|B|||
6353|119|P|PRECAUTIONS:  Before taking metoprolol, tell your doctor or||
6353|120|P|pharmacist if you are allergic to it; or to other beta-blockers||
6353|121|P|(such as atenolol, propranolol); or if you have any other||
6353|122|P|allergies. This product may contain inactive ingredients, which||
6353|123|P|can cause allergic reactions or other problems. Talk to your||
6353|124|P|pharmacist for more details.||
6353|125|P|   Before using this medication, tell your doctor or pharmacist||
6353|126|P|your medical history, especially of: certain types of heart||
6353|127|P|rhythm problems (such as a slow heartbeat, sick sinus syndrome,||
6353|128|P|second- or third-degree atrioventricular block), breathing||
6353|129|P|problems (such as asthma, chronic bronchitis, emphysema), liver||
6353|130|P|disease, heart failure, serious allergic reactions, including||
6353|131|P|those needing treatment with epinephrine, blood circulation||
6353|132|P|problems (such as Raynaud's disease, peripheral vascular||
6353|133|P|disease), mental/mood disorders (such as depression), a certain||
6353|134|P|muscle disease (myasthenia gravis).||
6353|135|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6353|136|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6353|137|P|machinery, or do anything that needs alertness until you can do||
6353|138|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
6353|139|P|are using marijuana (cannabis).||
6353|140|P|   Before having surgery, tell your doctor or dentist about all||
6353|141|P|the products you use (including prescription drugs,||
6353|142|P|nonprescription drugs, and herbal products).||
6353|143|P|   This product may prevent the fast/pounding heartbeat you would||
6353|144|P|usually feel when your blood sugar level falls too low||
6353|145|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
6353|146|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
6353|147|P|blood sugar level, such as dizziness and sweating, are not||
6353|148|P|affected by this drug.||
6353|149|P|   If you have diabetes, this product may make it harder to||
6353|150|P|control your blood sugar levels. Check your blood sugar levels||
6353|151|P|regularly as directed by your doctor. Tell your doctor right away||
6353|152|P|if you have symptoms of high blood sugar such as increased||
6353|153|P|thirst/urination. Your doctor may need to adjust your diabetes||
6353|154|P|medication, exercise program, or diet.||
6353|155|P|   Children may be at greater risk for low blood sugar||
6353|156|P|(hypoglycemia) while using this drug, especially if they are||
6353|157|P|vomiting or not eating regularly. To help prevent low blood||
6353|158|P|sugar, make sure children eat regularly. If your child cannot eat||
6353|159|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
6353|160|P|as sweating, shaking), tell the doctor right away.||
6353|161|P|   During pregnancy, this medication should be used only when||
6353|162|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
6353|163|P|benefits with your doctor.||
6353|164|P|   This drug passes into breast milk but is unlikely to harm a||
6353|165|P|nursing infant. Consult your doctor before breastfeeding.||
6353|166|B|||
6353|167|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6353|168|I|medications work or increase your risk for serious side effects.||
6353|169|I|This document does not contain all possible drug interactions.||
6353|170|I|Keep a list of all the products you use (including||
6353|171|I|prescription/nonprescription drugs and herbal products) and share||
6353|172|I|it with your doctor and pharmacist. Do not start, stop, or change||
6353|173|I|the dosage of any medicines without your doctor's approval.||
6353|174|I|   A product that may interact with this drug is: fingolimod.||
6353|175|I|   Other medications can affect the removal of metoprolol from||
6353|176|I|your body, which may affect how metoprolol works. Examples||
6353|177|I|include lumefantrine, propafenone, quinidine, SSRI||
6353|178|I|antidepressants (such as fluoxetine, paroxetine), St. John's||
6353|179|I|wort, among others.||
6353|180|I|   Some products have ingredients that could raise your heart||
6353|181|I|rate or blood pressure or worsen your heart failure. Tell your||
6353|182|I|pharmacist what products you are using, and ask how to use them||
6353|183|I|safely (especially cough-and-cold products, diet aids, or NSAIDs||
6353|184|I|such as ibuprofen/naproxen).||
6353|185|B|||
6353|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6353|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6353|188|O|poison control center right away. US residents can call||
6353|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6353|190|O|Symptoms of overdose may include: very slow heartbeat, severe||
6353|191|O|dizziness, severe weakness, fainting, trouble breathing.||
6353|192|B|||
6353|193|N|NOTES:  Do not share this medication with others.||
6353|194|N|   Talk with your doctor about lifestyle changes that may help||
6353|195|N|this medication work better (such as stress reduction programs,||
6353|196|N|exercise, and dietary changes).||
6353|197|N|   Have your blood pressure and pulse (heart rate) checked||
6353|198|N|regularly while taking this medication. Learn how to check your||
6353|199|N|own blood pressure and pulse at home, and share the results with||
6353|200|N|your doctor.||
6353|201|N|   Lab and/or medical tests (such as liver function) may be done||
6353|202|N|while you are taking this medication. Keep all medical and lab||
6353|203|N|appointments. Consult your doctor for more details.||
6353|204|B|||
6353|205|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6353|206|D|remember. If it is near the time of the next dose, skip the||
6353|207|D|missed dose. Take your next dose at the regular time. Do not||
6353|208|D|double the dose to catch up.||
6353|209|B|||
6353|210|R|STORAGE:  Store at room temperature away from light and moisture.||
6353|211|R|Do not store in the bathroom.||
6353|212|R|   Once opened, the liquid form of this medication expires after||
6353|213|R|30 days. Keep all medications away from children and pets.||
6353|214|R|   Do not flush medications down the toilet or pour them into a||
6353|215|R|drain unless instructed to do so. Properly discard this product||
6353|216|R|when it is expired or no longer needed. Consult your pharmacist||
6353|217|R|or local waste disposal company.||
6353|218|B|||
6353|219|A|Information last revised July 2025.||
6353|220|A|Copyright(c) 2025 First Databank, Inc.||
6353|221|B|||
6367|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6367|002|Z|does NOT have all possible information about this product. This||
6367|003|Z|information does not assure that this product is safe, effective,||
6367|004|Z|or appropriate for you. This information is not individual||
6367|005|Z|medical advice and does not substitute for the advice of your||
6367|006|Z|health care professional. Always ask your health care||
6367|007|Z|professional for complete information about this product and your||
6367|008|Z|specific health needs.||
6367|009|B|||
6367|010|T|ALPRAZOLAM CONCENTRATE SOLUTION - ORAL||
6367|011|F|(al-PRA-zoe-lam)||
6367|012|B|||
6367|013|C|COMMON BRAND NAME(S): Alprazolam Intensol||
6367|014|B|||
6367|015|W|WARNING:  Alprazolam has a risk for abuse and addiction, which||
6367|016|W|can lead to overdose and death. Taking this medication with||
6367|017|W|alcohol or other drugs that can cause drowsiness or breathing||
6367|018|W|problems (especially opioid medications such as codeine,||
6367|019|W|hydrocodone) may cause very serious side effects, including||
6367|020|W|death. To lower your risk, your doctor should have you take the||
6367|021|W|smallest dose of alprazolam that works, and take it for the||
6367|022|W|shortest possible time. Be sure you know how to take alprazolam||
6367|023|W|and what other drugs you should avoid taking with it. See also||
6367|024|W|Drug Interactions section. Get medical help right away if any of||
6367|025|W|these very serious side effects occur: slow/shallow breathing,||
6367|026|W|unusual lightheadedness, severe drowsiness/dizziness, difficulty||
6367|027|W|waking up.||
6367|028|W|   Suddenly stopping this medication may cause serious (possibly||
6367|029|W|fatal) withdrawal, especially if you have used it for a long time||
6367|030|W|or in high doses. To prevent withdrawal, your doctor may lower||
6367|031|W|your dose slowly. Tell your doctor or pharmacist right away if||
6367|032|W|you have any withdrawal symptoms such as headaches, trouble||
6367|033|W|sleeping, restlessness, hallucinations/confusion, depression,||
6367|034|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
6367|035|W|to months.||
6367|036|B|||
6367|037|U|USES:  Alprazolam is used to treat anxiety and panic disorders.||
6367|038|U|It belongs to a class of medications called benzodiazepines which||
6367|039|U|act on the brain and nerves (central nervous system) to produce a||
6367|040|U|calming effect. It works by enhancing the effects of a certain||
6367|041|U|natural chemical in the body (GABA).||
6367|042|B|||
6367|043|H|HOW TO USE:  See also Warning section.||
6367|044|H|   Read the Medication Guide provided by your pharmacist before||
6367|045|H|you start taking alprazolam and each time you get a refill. If||
6367|046|H|you have any questions, ask your doctor or pharmacist.||
6367|047|H|   Take this medication by mouth as directed by your doctor. Use||
6367|048|H|the dropper provided to carefully measure out the dose and mix it||
6367|049|H|in liquid or soft food (such as applesauce, pudding) just before||
6367|050|H|taking. The dosage is based on your medical condition, age, and||
6367|051|H|response to treatment. Your dose may be gradually increased until||
6367|052|H|the drug starts working well. Follow your doctor's instructions||
6367|053|H|closely to reduce the risk of side effects.||
6367|054|H|   Though it helps many people, this medication may sometimes||
6367|055|H|cause addiction. This risk may be higher if you have a substance||
6367|056|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
6367|057|H|Take this medication exactly as prescribed to lower the risk of||
6367|058|H|addiction. Ask your doctor or pharmacist for more details.||
6367|059|H|   When this medication is used for a long time, it may not work||
6367|060|H|as well. Talk with your doctor if this medication stops working||
6367|061|H|well.||
6367|062|H|   Tell your doctor if your condition lasts or gets worse.||
6367|063|B|||
6367|064|S|SIDE EFFECTS:  See also Warning section.||
6367|065|S|   Drowsiness, dizziness, increased saliva production, or change||
6367|066|S|in sex drive/ability may occur. If any of these effects last or||
6367|067|S|get worse, tell your doctor or pharmacist promptly.||
6367|068|S|   To reduce the risk of dizziness and lightheadedness, get up||
6367|069|S|slowly when rising from a sitting or lying position.||
6367|070|S|   Remember that this medication has been prescribed because your||
6367|071|S|doctor has judged that the benefit to you is greater than the||
6367|072|S|risk of side effects. Many people using this medication do not||
6367|073|S|have serious side effects.||
6367|074|S|   Tell your doctor right away if you have any serious side||
6367|075|S|effects, including: mental/mood changes (such as hallucinations,||
6367|076|S|thoughts of suicide), trouble speaking, loss of coordination,||
6367|077|S|trouble walking, memory problems.||
6367|078|S|   Get medical help right away if you have any very serious side||
6367|079|S|effects, including: yellowing eyes/skin, seizures.||
6367|080|S|   A very serious allergic reaction to this drug is rare.||
6367|081|S|However, get medical help right away if you notice any symptoms||
6367|082|S|of a serious allergic reaction, including: rash, itching/swelling||
6367|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6367|084|S|breathing.||
6367|085|S|   This is not a complete list of possible side effects. If you||
6367|086|S|notice other effects not listed above, contact your doctor or||
6367|087|S|pharmacist.||
6367|088|S|   In the US -||
6367|089|S|   Call your doctor for medical advice about side effects. You||
6367|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6367|091|S|www.fda.gov/medwatch.||
6367|092|S|   In Canada - Call your doctor for medical advice about side||
6367|093|S|effects. You may report side effects to Health Canada at||
6367|094|S|1-866-234-2345.||
6367|095|B|||
6367|096|P|PRECAUTIONS:  Before taking alprazolam, tell your doctor or||
6367|097|P|pharmacist if you are allergic to it; or to other benzodiazepines||
6367|098|P|(such as diazepam, lorazepam); or if you have any other||
6367|099|P|allergies. This product may contain inactive ingredients, which||
6367|100|P|can cause allergic reactions or other problems. Talk to your||
6367|101|P|pharmacist for more details.||
6367|102|P|   Before using this medication, tell your doctor or pharmacist||
6367|103|P|your medical history, especially of: lung/breathing problems||
6367|104|P|(such as COPD, sleep apnea), liver disease, kidney disease,||
6367|105|P|personal or family history of a substance use disorder (such as||
6367|106|P|overuse of or addiction to drugs/alcohol), glaucoma.||
6367|107|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
6367|108|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
6367|109|P|machinery, or do anything that needs alertness until you can do||
6367|110|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
6367|111|P|are using marijuana (cannabis).||
6367|112|P|   Before having surgery, tell your doctor or dentist about all||
6367|113|P|the products you use (including prescription drugs,||
6367|114|P|nonprescription drugs, and herbal products).||
6367|115|P|   Older adults may be more sensitive to the side effects of this||
6367|116|P|drug, especially loss of coordination and drowsiness. These side||
6367|117|P|effects can increase the risk of falling.||
6367|118|P|   Tell your doctor if you are pregnant or plan to become||
6367|119|P|pregnant. You should not become pregnant while using alprazolam.||
6367|120|P|Alprazolam may harm an unborn baby. Newborn babies of mothers who||
6367|121|P|use this medication late in pregnancy may have symptoms such as||
6367|122|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
6367|123|P|feeding. If you become pregnant, talk to your doctor right away||
6367|124|P|about the risks and benefits of this medication.||
6367|125|P|   This drug passes into breast milk and may have undesirable||
6367|126|P|effects on a nursing infant. Breastfeeding is not recommended||
6367|127|P|while using this drug. Consult your doctor before breastfeeding.||
6367|128|B|||
6367|129|I|DRUG INTERACTIONS:  See also Warning section.||
6367|130|I|   Drug interactions may change how your medications work or||
6367|131|I|increase your risk for serious side effects. This document does||
6367|132|I|not contain all possible drug interactions. Keep a list of all||
6367|133|I|the products you use (including prescription/nonprescription||
6367|134|I|drugs and herbal products) and share it with your doctor and||
6367|135|I|pharmacist. Do not start, stop, or change the dosage of any||
6367|136|I|medicines without your doctor's approval.||
6367|137|I|   Some products that may interact with this drug include: kava,||
6367|138|I|sodium oxybate.||
6367|139|I|   Other medications can affect the removal of alprazolam from||
6367|140|I|your body, which may affect how alprazolam works. Examples||
6367|141|I|include adagrasib, azole antifungals (such as itraconazole,||
6367|142|I|ketoconazole), cimetidine, certain anti-depressants (such as||
6367|143|I|fluoxetine, fluvoxamine, nefazodone), macrolide antibiotics (such||
6367|144|I|as erythromycin), rifamycins (such as rifabutin), St. John's||
6367|145|I|wort, drugs used to treat seizures (such as phenytoin), among||
6367|146|I|others.||
6367|147|I|   The risk of serious side effects (such as slow/shallow||
6367|148|I|breathing, severe drowsiness/dizziness) may be increased if this||
6367|149|I|medication is taken with other products that may also cause||
6367|150|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
6367|151|I|if you are taking other products such as opioid pain or cough||
6367|152|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
6367|153|I|(cannabis), other drugs for sleep or anxiety (such as diazepam,||
6367|154|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
6367|155|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
6367|156|I|diphenhydramine).||
6367|157|I|   Check the labels on all your medicines (such as allergy or||
6367|158|I|cough-and-cold products) because they may contain ingredients||
6367|159|I|that cause drowsiness. Ask your pharmacist about using those||
6367|160|I|products safely.||
6367|161|I|   Cigarette smoking decreases blood levels of this medication.||
6367|162|I|Tell your doctor if you smoke or if you have recently stopped||
6367|163|I|smoking.||
6367|164|B|||
6367|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6367|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6367|167|O|poison control center right away. US residents can call||
6367|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6367|169|O|Symptoms of overdose may include: severe drowsiness,||
6367|170|O|slowed/reduced reflexes, slowed breathing, loss of consciousness.||
6367|171|B|||
6367|172|N|NOTES:  Do not share this medication with others. Sharing it is||
6367|173|N|against the law.||
6367|174|N|   Lab and/or medical tests (such as liver function) should be||
6367|175|N|done while you are taking this medication. Keep all medical and||
6367|176|N|lab appointments. Consult your doctor for more details.||
6367|177|B|||
6367|178|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6367|179|D|remember. If it is near the time of the next dose, skip the||
6367|180|D|missed dose. Take your next dose at the regular time. Do not||
6367|181|D|double the dose to catch up.||
6367|182|B|||
6367|183|R|STORAGE:  Store at room temperature away from light. Once the||
6367|184|R|bottle is opened, this medication expires after 90 days. Keep all||
6367|185|R|medications away from children and pets.||
6367|186|R|   Do not flush medications down the toilet or pour them into a||
6367|187|R|drain unless instructed to do so. Properly discard this product||
6367|188|R|when it is expired or no longer needed. Consult your pharmacist||
6367|189|R|or local waste disposal company.||
6367|190|B|||
6367|191|A|Information last revised April 2025.||
6367|192|A|Copyright(c) 2025 First Databank, Inc.||
6367|193|B|||
6372|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6372|002|Z|does NOT have all possible information about this product. This||
6372|003|Z|information does not assure that this product is safe, effective,||
6372|004|Z|or appropriate for you. This information is not individual||
6372|005|Z|medical advice and does not substitute for the advice of your||
6372|006|Z|health care professional. Always ask your health care||
6372|007|Z|professional for complete information about this product and your||
6372|008|Z|specific health needs.||
6372|009|B|||
6372|010|T|VALSARTAN - ORAL||
6372|011|F|(val-SAR-tan)||
6372|012|B|||
6372|013|C|COMMON BRAND NAME(S): Diovan||
6372|014|B|||
6372|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
6372|016|W|unborn baby if used during pregnancy. It is important to prevent||
6372|017|W|pregnancy while taking this medication. Consult your doctor for||
6372|018|W|more details and to discuss the use of reliable forms of birth||
6372|019|W|control while taking this medication. If you are planning||
6372|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
6372|021|W|your doctor right away.||
6372|022|B|||
6372|023|U|USES:  Valsartan is used to treat high blood pressure and heart||
6372|024|U|failure. It is also used to improve the chance of living longer||
6372|025|U|after a heart attack. In people with heart failure, it may also||
6372|026|U|lower the chance of having to go to the hospital for heart||
6372|027|U|failure. Valsartan belongs to a class of drugs called angiotensin||
6372|028|U|receptor blockers (ARBs). It works by relaxing blood vessels so||
6372|029|U|that blood can flow more easily. Lowering high blood pressure||
6372|030|U|helps prevent strokes, heart attacks, and kidney problems.||
6372|031|B|||
6372|032|V|OTHER USES:  This section contains uses of this drug that are not||
6372|033|V|listed in the approved professional labeling for the drug but||
6372|034|V|that may be prescribed by your health care professional. Use this||
6372|035|V|drug for a condition that is listed in this section only if it||
6372|036|V|has been so prescribed by your health care professional.||
6372|037|V|   This medication may also be used for kidney disease and to||
6372|038|V|help protect the kidneys from harm due to diabetes.||
6372|039|B|||
6372|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
6372|041|H|from your pharmacist before you start taking valsartan and each||
6372|042|H|time you get a refill. If you have any questions, ask your doctor||
6372|043|H|or pharmacist.||
6372|044|H|   Take this medication by mouth with or without food as directed||
6372|045|H|by your doctor, usually once or twice daily. The dosage is based||
6372|046|H|on your medical condition and response to treatment. Children's||
6372|047|H|dosage is also based on weight.||
6372|048|H|   If you are using the liquid form of this medication, carefully||
6372|049|H|measure the dose using a special measuring device/spoon. Do not||
6372|050|H|use a household spoon because you may not get the correct dose.||
6372|051|H|If your liquid form is a suspension, shake the bottle well for at||
6372|052|H|least 10 seconds before each dose.||
6372|053|H|   Use this medication regularly to get the most benefit from it.||
6372|054|H|To help you remember, take it at the same time(s) each day. Keep||
6372|055|H|taking this medication even if you feel well. Most people with||
6372|056|H|high blood pressure do not feel sick.||
6372|057|H|   Tell your doctor if your condition does not get better or if||
6372|058|H|it gets worse (for example, your blood pressure readings remain||
6372|059|H|high or increase).||
6372|060|B|||
6372|061|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
6372|062|S|body adjusts to the medication. If any of these effects last or||
6372|063|S|get worse, tell your doctor or pharmacist promptly.||
6372|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
6372|065|S|slowly when rising from a sitting or lying position.||
6372|066|S|   Remember that this medication has been prescribed because your||
6372|067|S|doctor has judged that the benefit to you is greater than the||
6372|068|S|risk of side effects. Many people using this medication do not||
6372|069|S|have serious side effects.||
6372|070|S|   Tell your doctor right away if you have any serious side||
6372|071|S|effects, including: fainting, symptoms of a high potassium blood||
6372|072|S|level (such as muscle weakness, slow/irregular heartbeat).||
6372|073|S|   Although valsartan may be used to prevent kidney problems or||
6372|074|S|treat people who have kidney problems, it may also rarely cause||
6372|075|S|serious kidney problems or make them worse. Your doctor will||
6372|076|S|check your kidney function while you are taking valsartan. Tell||
6372|077|S|your doctor right away if you have any signs of kidney problems||
6372|078|S|such as a change in the amount of urine.||
6372|079|S|   A very serious allergic reaction to this drug is rare.||
6372|080|S|However, get medical help right away if you notice any symptoms||
6372|081|S|of a serious allergic reaction, including: rash, itching/swelling||
6372|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6372|083|S|breathing.||
6372|084|S|   This is not a complete list of possible side effects. If you||
6372|085|S|notice other effects not listed above, contact your doctor or||
6372|086|S|pharmacist.||
6372|087|S|   In the US -||
6372|088|S|   Call your doctor for medical advice about side effects. You||
6372|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6372|090|S|www.fda.gov/medwatch.||
6372|091|S|   In Canada - Call your doctor for medical advice about side||
6372|092|S|effects. You may report side effects to Health Canada at||
6372|093|S|1-866-234-2345.||
6372|094|B|||
6372|095|P|PRECAUTIONS:  Before taking valsartan, tell your doctor or||
6372|096|P|pharmacist if you are allergic to it; or if you have any other||
6372|097|P|allergies. This product may contain inactive ingredients, which||
6372|098|P|can cause allergic reactions or other problems. Talk to your||
6372|099|P|pharmacist for more details.||
6372|100|P|   Before using this medication, tell your doctor or pharmacist||
6372|101|P|your medical history, especially of: liver disease, dehydration,||
6372|102|P|high level of potassium in the blood.||
6372|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
6372|104|P|can make you more dizzy. Do not drive, use machinery, or do||
6372|105|P|anything that needs alertness until you can do it safely. Limit||
6372|106|P|alcoholic beverages. Talk to your doctor if you are using||
6372|107|P|marijuana (cannabis).||
6372|108|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
6372|109|P|and cause you to feel lightheaded. Tell your doctor if you have||
6372|110|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
6372|111|P|of fluids unless your doctor tells you not to.||
6372|112|P|   This medication may increase your potassium levels. Before||
6372|113|P|using potassium supplements or salt substitutes that contain||
6372|114|P|potassium, consult your doctor or pharmacist.||
6372|115|P|   Liquid products may contain sugar and/or aspartame. Caution is||
6372|116|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
6372|117|P|condition that requires you to limit/avoid these substances in||
6372|118|P|your diet.||
6372|119|P|   Before having surgery, tell your doctor or dentist about all||
6372|120|P|the products you use (including prescription drugs,||
6372|121|P|nonprescription drugs, and herbal products).||
6372|122|P|   Tell your doctor if you are pregnant or plan to become||
6372|123|P|pregnant. You should not become pregnant while using valsartan.||
6372|124|P|Valsartan may harm an unborn baby. If you become pregnant, talk||
6372|125|P|to your doctor right away about the risks and benefits of this||
6372|126|P|medication. (See also Warning section.)||
6372|127|P|   It is unknown if this drug passes into breast milk. Consult||
6372|128|P|your doctor before breastfeeding.||
6372|129|B|||
6372|130|I|DRUG INTERACTIONS:  See also Precautions section.||
6372|131|I|   Drug interactions may change how your medications work or||
6372|132|I|increase your risk for serious side effects. This document does||
6372|133|I|not contain all possible drug interactions. Keep a list of all||
6372|134|I|the products you use (including prescription/nonprescription||
6372|135|I|drugs and herbal products) and share it with your doctor and||
6372|136|I|pharmacist. Do not start, stop, or change the dosage of any||
6372|137|I|medicines without your doctor's approval.||
6372|138|I|   Some products that may interact with this drug include:||
6372|139|I|aliskiren, lithium, drugs that may increase the level of||
6372|140|I|potassium in the blood (such as sparsentan, ACE inhibitors||
6372|141|I|including benazepril/lisinopril, birth control pills containing||
6372|142|I|drospirenone).||
6372|143|I|   Some products have ingredients that could raise your blood||
6372|144|I|pressure or worsen your heart failure. Tell your pharmacist what||
6372|145|I|products you are using, and ask how to use them safely||
6372|146|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
6372|147|I|ibuprofen/naproxen).||
6372|148|B|||
6372|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
6372|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
6372|151|O|poison control center right away. US residents can call||
6372|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
6372|153|O|Symptoms of overdose may include: severe dizziness, fainting.||
6372|154|B|||
6372|155|N|NOTES:  Do not share this medication with others.||
6372|156|N|   Lifestyle changes that may help this medication work better||
6372|157|N|include exercising, stopping smoking, and eating a||
6372|158|N|low-cholesterol/low-fat diet. Consult your doctor for more||
6372|159|N|details.||
6372|160|N|   Lab and/or medical tests (such as kidney function, potassium||
6372|161|N|levels) should be done while you are taking this medication. Keep||
6372|162|N|all medical and lab appointments.||
6372|163|N|   Check your blood pressure regularly while taking this||
6372|164|N|medication. Learn how to monitor your own blood pressure, and||
6372|165|N|share the results with your doctor.||
6372|166|B|||
6372|167|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
6372|168|D|remember. If it is near the time of the next dose, skip the||
6372|169|D|missed dose. Take your next dose at the regular time. Do not||
6372|170|D|double the dose to catch up.||
6372|171|B|||
6372|172|R|STORAGE:  Store this medication at room temperature away from||
6372|173|R|light and moisture. Do not store in the bathroom. Store the||
6372|174|R|suspension form of this medication at room temperature for up to||
6372|175|R|30 days, or in the refrigerator for up to 75 days. Do not freeze.||
6372|176|R|Keep all medications away from children and pets.||
6372|177|R|   Do not flush medications down the toilet or pour them into a||
6372|178|R|drain unless instructed to do so. Properly discard this product||
6372|179|R|when it is expired or no longer needed. Consult your pharmacist||
6372|180|R|or local waste disposal company.||
6372|181|B|||
6372|182|A|Information last revised January 2025.||
6372|183|A|Copyright(c) 2025 First Databank, Inc.||
6372|184|B|||
6378|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
6378|002|Z|does NOT have all possible information about this product. This||
6378|003|Z|information does not assure that this product is safe, effective,||
6378|004|Z|or appropriate for you. This information is not individual||
6378|005|Z|medical advice and does not substitute for the advice of your||
6378|006|Z|health care professional. Always ask your health care||
6378|007|Z|professional for complete information about this product and your||
6378|008|Z|specific health needs.||
6378|009|B|||
6378|010|T|ESTRADIOL/LEVONORGESTREL WEEKLY - TRANSDERMAL||
6378|011|F|(ES-tra-DYE-ol/LEE-voe-nor-JES-trel)||
6378|012|B|||
6378|013|C|COMMON BRAND NAME(S): Climara Pro||
6378|014|B|||
6378|015|W|WARNING:  Estrogens, either used alone or with a progestin, have||
6378|016|W|rarely caused very serious side effects. Discuss the risks and||
6378|017|W|benefits of hormone treatment with your doctor. Estrogens and||
6378|018|W|progestins should not be used to prevent heart disease or||
6378|019|W|dementia.||
6378|020|W|   In postmenopausal women, estrogen when used with a progestin||
6378|021|W|can increase the risk of heart disease (such as heart attacks),||
6378|022|W|stroke, serious blood clots in the lungs/legs, dementia, and||
6378|023|W|cancer of the breast/ovaries.||
6378|024|W|   The risk for serious side effects may depend on the dose of||
6378|025|W|estrogen and the length of time it is used. This medication||
6378|026|W|should be used at the lowest effective dose and for the shortest||
6378|027|W|amount of time. Discuss the use of this medication with your||
6378|028|W|doctor regularly (for example, every 3 to 6 months) to see if you||
6378|029|W|still need to use it. If you will be using this medication||
6378|030|W|long-term, you should have regular complete physical exams (for||
6378|031|W|example, once a year) as directed by your doctor. See also Notes||
6378|032|W|section.||
6378|033|B|||
6378|034|U|USES:  This medication contains 2 hormones: an estrogen||
6378|035|U|(estradiol) and a progestin (levonorgestrel). It is used by women||
6378|036|U|to help reduce a certain symptom of menopause (hot flashes).||
6378|037|U|Symptoms of menopause are caused by the body making less||
6378|038|U|estrogen. The progestin in this medication helps to reduce the||
6378|039|U|risk of cancer of the uterus which can be caused by using||
6378|040|U|estrogen. Women who have had their uterus removed do not need the||
6378|041|U|progestin. They should not use this combination medication.||
6378|042|U|   If you are using this medication to treat symptoms only in and||
6378|043|U|around the vagina, products applied directly inside the vagina||
6378|044|U|should be considered before medications that are taken by mouth,||
6378|045|U|absorbed through the skin, or injected.||
6378|046|U|   This medication may also be used by women after menopause to||
6378|047|U|prevent bone loss (osteoporosis). However, there are other||
6378|048|U|medications (such as raloxifene, bisphosphonates including||
6378|049|U|alendronate) that are also effective in preventing bone loss and||
6378|050|U|may be safer. These medications should be considered for use||
6378|051|U|before estrogen/progestin treatment.||
6378|052|B|||
6378|053|H|HOW TO USE:  Read the Patient Information Leaflet and||
6378|054|H|Instructions for Use if available from your pharmacist before you||
6378|055|H|start using this medication and each time you get a refill. If||
6378|056|H|you have any questions, ask your doctor or pharmacist.||
6378|057|H|   Peel off the backing from the patch and apply the patch to a||
6378|058|H|clean, dry area of the lower stomach. Press the patch firmly in||
6378|059|H|place for about 10 seconds to make sure it stays on. Do not apply||
6378|060|H|the patch on the breast or on oily, broken, or irritated skin.||
6378|061|H|Avoid applying the patch to areas of the skin where it might be||
6378|062|H|easily rubbed off (such as the waistline). When wearing the||
6378|063|H|patch, do not expose it to the sun for long periods of time. Use||
6378|064|H|this medication as directed by your doctor. The patch is usually||
6378|065|H|worn for 1 week and then replaced. Follow the dosing schedule||
6378|066|H|carefully.||
6378|067|H|   When replacing your patch, make sure to apply the new patch to||
6378|068|H|a different area. Wait at least 1 week before applying a patch to||
6378|069|H|the same area. Fold the old patch in half with the sticky side||
6378|070|H|together and throw away in the trash away from children and pets.||
6378|071|H|Do not flush the patch down the toilet.||
6378|072|H|   If a patch falls off, reapply it to a different area. If the||
6378|073|H|patch does not stick completely, then apply a new patch and wear||
6378|074|H|it for the rest of the 7-day period. Do not wear 2 patches at the||
6378|075|H|same time.||
6378|076|H|   Use this medication regularly to get the most benefit from it.||
6378|077|H|To help you remember, change the patch on the same day each week.||
6378|078|H|Mark your calendar with a reminder.||
6378|079|H|   Tell your doctor if your condition does not get better or if||
6378|080|H|it gets worse.||
6378|081|B|||
6378|082|S|SIDE EFFECTS:  See also Warning section.||
6378|083|S|   Skin redness/irritation at the application site, abdominal||
6378|084|S|pain, nausea/vomiting, bloating, breast tenderness, headache, or||
6378|085|S|weight changes may occur. If any of these effects last or get||
6378|086|S|worse, tell your doctor or pharmacist promptly.||
6378|087|S|   Remember that this medication has been prescribed because your||
6378|088|S|doctor has judged that the benefit to you is greater than the||
6378|089|S|risk of side effects. Many people using this medication do not||
6378|090|S|have serious side effects.||
6378|091|S|   Tell your doctor right away if you have any serious side||
6378|092|S|effects, including: nausea/vomiting that doesn't stop,||
6378|093|S|mental/mood changes (such as depression, memory loss), breast||
6378|094|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
6378|095|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
6378|096|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
6378|097|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
6378|098|S|increased thirst/urination.||
6378|099|S|   This medication may rarely cause serious (sometimes fatal)||
6378|100|S|problems from blood clots (such as heart attack, stroke, blood||
6378|101|S|clots in the lungs or legs). Get medical help right away if you||
6378|102|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
6378|103|S|headaches, weakness on one side of the body, confusion, trouble||
6378|104|S|speaking, sudden vision changes, pain/swelling/warmth in the||
6378|105|S|groin/calf, shortness of breath/rapid breathing, sudden||
6378|106|S|dizziness/fainting.||
6378|107|S|   A very serious allergic reaction to this product is rare.||
6378|108|S|However, get medical help right away if you notice any symptoms||
6378|109|S|of a serious allergic reaction, including: rash, itching/swelling||
6378|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
6378|111|S|breathing.||
6378|112|S|   This is not a complete list of possible side effects. If you||
6378|113|S|notice other effects not listed above, contact your doctor or||
6378|114|S|pharmacist.||
6378|115|S|   In the US -||
6378|116|S|   Call your doctor for medical advice about side effects. You||
6378|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
6378|118|S|www.fda.gov/medwatch.||
6378|119|S|   In Canada - Call your doctor for medical advice about side||
6378|120|S|effects. You may report side effects to Health Canada at||
6378|121|S|1-866-234-2345.||
6378|122|B|||
6378|123|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
6378|124|P|pharmacist if you are allergic to estradiol or levonorgestrel; or||
6378|125|P|if you have any other allergies. This product may contain||
6378|126|P|inactive ingredients, which can cause allergic reactions or other||
6378|127|P|problems. Talk to your pharmacist for more details.||
6378|128|P|   Before using this medication, tell your doctor or pharmacist||
6378|129|P|your medical history, especially of: vaginal bleeding of unknown||
6378|130|P|cause, certain cancers (such as breast cancer, cancer of the||
6378|131|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
6378|132|P|heart attack), liver disease, kidney disease, family medical||
6378|133|P|history (especially breast lumps, cancer, blood clots), family or||
6378|134|P|personal history of a certain swelling disorder (angioedema),||
6378|135|P|blood clotting disorders (such as protein C or protein S||
6378|136|P|deficiency), high blood pressure, diabetes, high blood||
6378|137|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
6378|138|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
6378|139|P|calcium in the blood), a certain hormone problem||
6378|140|P|(hypoparathyroidism), uterus problems (such as fibroids,||
6378|141|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
6378|142|P|headaches, a certain blood disorder (porphyria), mental/mood||
6378|143|P|disorders (such as dementia, depression).||
6378|144|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
6378|145|P|further increases your risk of stroke, blood clots, high blood||
6378|146|P|pressure, and heart attack, especially in women older than 35.||
6378|147|P|   Tell your doctor if you just had or will be having surgery, or||
6378|148|P|if you will be confined to a chair or bed for a long time (such||
6378|149|P|as a long plane flight). These conditions increase your risk of||
6378|150|P|getting blood clots, especially if you are using an estrogen||
6378|151|P|product. You may need to stop this medication for a time or take||
6378|152|P|special precautions.||
6378|153|P|   This medication may cause blotchy, dark areas on your face and||
6378|154|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
6378|155|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
6378|156|P|wear protective clothing when outdoors.||
6378|157|P|   If you are nearsighted or wear contact lenses, you may develop||
6378|158|P|vision problems or trouble wearing your contact lenses. Consult||
6378|159|P|your eye doctor if these problems occur.||
6378|160|P|   If you are going to have an MRI test, tell testing personnel||
6378|161|P|that you are using this patch. Some patches may contain metals||
6378|162|P|that can cause serious burns during an MRI. Ask your doctor||
6378|163|P|whether you will need to remove your patch before the test and||
6378|164|P|apply a new patch afterward, and how to do so properly.||
6378|165|P|   This medication should not be used during pregnancy. If you||
6378|166|P|become pregnant or think you may be pregnant, tell your doctor||
6378|167|P|right away.||
6378|168|P|   This medication passes into breast milk. Consult your doctor||
6378|169|P|before breastfeeding.||
6378|170|B|||
6378|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
6378|172|I|medications work or increase your risk for serious side effects.||
6378|173|I|This document does not contain all possible drug interactions.||
6378|174|I|Keep a list of all the products you use (including||
6378|175|I|prescription/nonprescription drugs and herbal products) and share||
6378|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
6378|177|I|the dosage of any medicines without your doctor's approval.||
6378|178|I|   Some products that may interact with this drug include:||
6378|179|I|aromatase inhibitors (such as anastrozole, exemestane,||
6378|180|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
6378|181|I|tamoxifen, toremifene, tranexamic acid.||
6378|182|I|   This medication may interfere with certain lab tests (such as||
6378|183|I|metyrapone test), possibly causing false test results. Make sure||
6378|184|I|lab personnel and all your doctors know you use this drug.||
6378|185|B|||
6378|186|O|OVERDOSE:  This medication patch may be harmful if chewed or||
6378|187|O|swallowed. If someone has overdosed, remove the patch if||
6378|188|O|possible. For serious symptoms such as passing out or trouble||
6378|189|O|breathing, call 911. Otherwise, call a poison control center||
6378|190|O|right away. US residents can call 1-800-222-1222. Canada||
6378|191|O|residents can call 1-844-764-7669.||
6378|192|B|||
6378|193|N|NOTES:  Do not share this medication with others.||
6378|194|N|   Regular complete physical exams which include lab and/or||
6378|195|N|medical tests (such as blood pressure, breast exam/mammogram,||
6378|196|N|pelvic exam, Pap smear) should be done while you are using this||
6378|197|N|medication. Follow your doctor's instructions for examining your||
6378|198|N|breasts, and report any lumps right away. Keep all medical and||
6378|199|N|lab appointments. Consult your doctor for more details.||
6378|200|N|   Preventing or controlling high blood pressure, high||
6378|201|N|cholesterol, and diabetes can help to reduce your chances of||
6378|202|N|heart disease and stroke. Lifestyle changes that can help to||
6378|203|N|control or prevent these diseases include reducing stress, eating||
6378|204|N|a low fat/salt diet, losing weight if overweight, exercising||
6378|205|N|regularly, and stopping smoking. Keep your mind active with||
6378|206|N|mental exercises (such as reading, solving crossword puzzles) to||
6378|207|N|help prevent dementia. Talk to your doctor about lifestyle||
6378|208|N|changes that might benefit you.||
6378|209|N|   Lifestyle changes that may help reduce hot flashes include||
6378|210|N|stopping smoking, dressing lightly or in layers,||
6378|211|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
6378|212|N|reducing stress, and exercising regularly.||
6378|213|N|   Lifestyle changes that help promote healthy bones include||
6378|214|N|increasing weight-bearing exercise, stopping smoking, limiting||
6378|215|N|alcohol, and eating well-balanced meals that contain adequate||
6378|216|N|calcium and vitamin D. Since you may also need to take calcium||
6378|217|N|and vitamin D supplements and make lifestyle changes, consult||
6378|218|N|your doctor for specific advice.||
6378|219|B|||
6378|220|D|MISSED DOSE:  If you forget to replace a patch at the scheduled||
6378|221|D|time, replace it as soon as you remember. Do not use more than||
6378|222|D|one patch at a time.||
6378|223|B|||
6378|224|R|STORAGE:  Store at room temperature. Do not remove the patch from||
6378|225|R|the pouch until ready for use. Keep all medications away from||
6378|226|R|children and pets.||
6378|227|R|   Do not flush medications down the toilet or pour them into a||
6378|228|R|drain unless instructed to do so. Properly discard this product||
6378|229|R|when it is expired or no longer needed (see How to Use section).||
6378|230|B|||
6378|231|A|Information last revised October 2024.||
6378|232|A|Copyright(c) 2025 First Databank, Inc.||
6378|233|B|||
7003|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7003|002|Z|does NOT have all possible information about this product. This||
7003|003|Z|information does not assure that this product is safe, effective,||
7003|004|Z|or appropriate for you. This information is not individual||
7003|005|Z|medical advice and does not substitute for the advice of your||
7003|006|Z|health care professional. Always ask your health care||
7003|007|Z|professional for complete information about this product and your||
7003|008|Z|specific health needs.||
7003|009|B|||
7003|010|T|ASPIRIN SUPPOSITORY - RECTAL||
7003|011|F|(AS-pir-in)||
7003|012|B|||
7003|013|U|USES:  This medication is used to reduce fever and relieve minor||
7003|014|U|to moderate pain from conditions such as muscle aches,||
7003|015|U|toothaches, menstrual cramps, arthritis, and headaches. Aspirin||
7003|016|U|is known as a salicylate and a nonsteroidal anti-inflammatory||
7003|017|U|drug (NSAID) that works by blocking a certain natural substance||
7003|018|U|in your body to reduce pain and swelling.||
7003|019|U|   Aspirin is also used in low doses as a blood thinner to||
7003|020|U|prevent blood clots after surgery on clogged arteries (such as||
7003|021|U|bypass surgery, carotid endarterectomy) and to reduce the risk of||
7003|022|U|stroke or heart attack.||
7003|023|B|||
7003|024|H|HOW TO USE:  If you are using this medication for self-treatment,||
7003|025|H|carefully read the product label to make sure this product is||
7003|026|H|correct for you or your child. You should also read the product||
7003|027|H|label to find recommendations on the maximum number of||
7003|028|H|suppositories you can use in a 24-hour period, and the maximum||
7003|029|H|length of self-treatment before seeking medical advice. Talk to||
7003|030|H|your doctor or pharmacist if you have any questions about this||
7003|031|H|medication. If you are using this medication under the||
7003|032|H|instruction of your doctor, use it exactly as prescribed.||
7003|033|H|   Apply this medication rectally as directed by your doctor, or,||
7003|034|H|if you are self-treating, follow instructions on the product||
7003|035|H|label. If the suppository is too soft to insert, put it in cold||
7003|036|H|water or refrigerate for 30 minutes before removing the foil||
7003|037|H|wrapper. Unwrap the foil and moisten the suppository with a||
7003|038|H|little water. Lie down on your left side with right knee bent.||
7003|039|H|Insert the suppository into the rectum with your finger. Remain||
7003|040|H|lying down for a few minutes and avoid having a bowel movement||
7003|041|H|for an hour or longer so the drug will be absorbed.||
7003|042|H|   The dosage and length of aspirin treatment are based on your||
7003|043|H|medical condition and response to treatment. Consult your doctor||
7003|044|H|before treating a child younger than 12. This medication should||
7003|045|H|not be used for self-treatment of pain for longer than 10 days in||
7003|046|H|adults or 5 days in children. This drug should not be used by||
7003|047|H|adults or children for fever lasting longer than 3 days or for||
7003|048|H|sore throat pain lasting longer than 2 days. No more than 5 doses||
7003|049|H|of this medication should be given to a child for pain or fever||
7003|050|H|in a 24-hour period. Do not use more medication or use it for||
7003|051|H|longer than recommended above unless directed by your doctor. Use||
7003|052|H|the smallest effective dose. Consult your doctor or pharmacist if||
7003|053|H|you have any questions.||
7003|054|H|   If you are using this medication for self-treatment of||
7003|055|H|headache, get medical help right away if you also have trouble||
7003|056|H|speaking, weakness on one side of the body, or sudden vision||
7003|057|H|changes. Before using this drug, consult a doctor or pharmacist||
7003|058|H|if you have headaches caused by head injury, coughing, or||
7003|059|H|bending, or if you have a headache with vomiting, fever, and||
7003|060|H|stiff neck.||
7003|061|H|   If you are using this medication on an as needed basis (not on||
7003|062|H|a regular schedule), remember that pain medications work best if||
7003|063|H|they are used as the first signs of pain occur. If you wait until||
7003|064|H|the pain has significantly worsened, the medicine may not work as||
7003|065|H|well.||
7003|066|H|   Consult your doctor if your condition lasts or gets worse (for||
7003|067|H|example, if you have new or unusual symptoms, redness/swelling of||
7003|068|H|the painful area, pain/fever that does not go away or gets||
7003|069|H|worse).||
7003|070|B|||
7003|071|S|SIDE EFFECTS:  Irritation of the rectal area may occur. If this||
7003|072|S|effect lasts or gets worse, tell your doctor or pharmacist||
7003|073|S|promptly.||
7003|074|S|   If your doctor has directed you to use this medication,||
7003|075|S|remember that your doctor has judged that the benefit to you is||
7003|076|S|greater than the risk of side effects. Many people using this||
7003|077|S|medication do not have serious side effects.||
7003|078|S|   Tell your doctor right away if you have any serious side||
7003|079|S|effects, including: nausea/vomiting that doesn't stop, easy||
7003|080|S|bruising/bleeding, difficulty hearing, ringing in the ears, signs||
7003|081|S|of kidney problems (such as change in the amount of urine),||
7003|082|S|unexplained tiredness, dizziness, dark urine, yellowing of the||
7003|083|S|eyes/skin.||
7003|084|S|   This drug may rarely cause serious bleeding from the||
7003|085|S|stomach/intestine or other areas of the body. If you notice any||
7003|086|S|of the following very serious side effects, get medical help||
7003|087|S|right away: stomach/abdominal pain that is severe or doesn't go||
7003|088|S|away, black/tarry stools, vomit that looks like coffee grounds,||
7003|089|S|trouble speaking, weakness on one side of the body, sudden vision||
7003|090|S|changes or severe headache.||
7003|091|S|   A very serious allergic reaction to this drug is rare.||
7003|092|S|However, get medical help right away if you notice any symptoms||
7003|093|S|of a serious allergic reaction, including: fever, swollen lymph||
7003|094|S|nodes, rash, itching/swelling (especially of the||
7003|095|S|face/tongue/throat), severe dizziness, trouble breathing.||
7003|096|S|   This is not a complete list of possible side effects. If you||
7003|097|S|notice other effects not listed above, contact your doctor or||
7003|098|S|pharmacist.||
7003|099|S|   In the US -||
7003|100|S|   Call your doctor for medical advice about side effects. You||
7003|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7003|102|S|www.fda.gov/medwatch.||
7003|103|S|   In Canada - Call your doctor for medical advice about side||
7003|104|S|effects. You may report side effects to Health Canada at||
7003|105|S|1-866-234-2345.||
7003|106|B|||
7003|107|P|PRECAUTIONS:  Before taking aspirin, tell your doctor or||
7003|108|P|pharmacist if you are allergic to it; or to other salicylates||
7003|109|P|(such as choline salicylate); or to other pain relievers or fever||
7003|110|P|reducers (acetaminophen, NSAIDs such as ibuprofen, naproxen); or||
7003|111|P|if you have any other allergies. This product may contain||
7003|112|P|inactive ingredients, which can cause allergic reactions or other||
7003|113|P|problems. Talk to your pharmacist for more details.||
7003|114|P|   If you have any of the following health problems, consult your||
7003|115|P|doctor or pharmacist before using this medication: kidney||
7003|116|P|disease, liver disease, stomach problems (such as ulcers,||
7003|117|P|heartburn, stomach pain), bleeding/blood-clotting disorders (such||
7003|118|P|as hemophilia, vitamin K deficiency, low platelet count), asthma||
7003|119|P|(including a history of worsening breathing after taking aspirin||
7003|120|P|or other NSAIDs), growths in the nose (nasal polyps), gout,||
7003|121|P|anemia, certain enzyme deficiencies (pyruvate kinase or G6-PD||
7003|122|P|deficiency).||
7003|123|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
7003|124|P|and tobacco, especially when combined with this product, may||
7003|125|P|increase your risk for this side effect. Limit alcoholic||
7003|126|P|beverages, and stop smoking. Check with your doctor or pharmacist||
7003|127|P|for more information.||
7003|128|P|   Before having surgery, tell your doctor or dentist about all||
7003|129|P|the products you use (including prescription drugs,||
7003|130|P|nonprescription drugs, and herbal products).||
7003|131|P|   Older adults may be more sensitive to the side effects of this||
7003|132|P|drug, especially stomach/intestinal bleeding and ulcers.||
7003|133|P|   This drug contains aspirin. Children and teenagers less than||
7003|134|P|18 years old should not use aspirin if they have chickenpox,||
7003|135|P|influenza or any undiagnosed illness without first consulting a||
7003|136|P|doctor about Reyes syndrome, a rare but serious illness.||
7003|137|P|   Aspirin is not recommended for use to treat pain or fever||
7003|138|P|during pregnancy. Before using this medication, women of||
7003|139|P|childbearing age should talk with their doctor(s) about the||
7003|140|P|benefits and risks. Tell your doctor if you are pregnant or if||
7003|141|P|you plan to become pregnant. This medication may harm an unborn||
7003|142|P|baby and cause problems with normal labor/delivery. It is not||
7003|143|P|recommended for use in pregnancy from 20 weeks until delivery. If||
7003|144|P|your doctor decides that you need to use this medication between||
7003|145|P|20 and 30 weeks of pregnancy, you should use the lowest effective||
7003|146|P|dose for the shortest possible time. In some cases, low-dose||
7003|147|P|aspirin (usually 81-162 milligrams a day) may be used safely||
7003|148|P|during pregnancy to prevent certain conditions. Talk to your||
7003|149|P|doctor for more details.||
7003|150|P|   Aspirin passes into breast milk. When used in large amounts||
7003|151|P|(such as to treat pain or fever), it may harm a nursing infant||
7003|152|P|and breastfeeding is not recommended while using this medication.||
7003|153|P|However, low-dose aspirin for heart attack or stroke prevention||
7003|154|P|may be used if directed by your doctor. Consult your doctor||
7003|155|P|before breastfeeding.||
7003|156|B|||
7003|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7003|158|I|medications work or increase your risk for serious side effects.||
7003|159|I|This document does not contain all possible drug interactions.||
7003|160|I|Keep a list of all the products you use (including||
7003|161|I|prescription/nonprescription drugs and herbal products) and share||
7003|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
7003|163|I|the dosage of any medicines without your doctor's approval.||
7003|164|I|   Some products that may interact with this drug include:||
7003|165|I|acetazolamide, "blood thinners" (such as warfarin, heparin),||
7003|166|I|corticosteroids (such as prednisone), dichlorphenamide,||
7003|167|I|methotrexate, mifepristone, certain medications for gout (such as||
7003|168|I|probenecid), anti-seizure drugs (such as phenytoin, valproic||
7003|169|I|acid), herbal medications (such as ginkgo biloba).||
7003|170|I|   Before using this product, consult your doctor if your child||
7003|171|I|has recently received certain live vaccines (such as varicella||
7003|172|I|vaccine, live influenza vaccine).||
7003|173|I|   Check all prescription and nonprescription medicine labels||
7003|174|I|carefully since many medications contain pain relievers/fever||
7003|175|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
7003|176|I|naproxen). These drugs are similar to this medication and may||
7003|177|I|increase your risk of side effects if used together.||
7003|178|I|   Daily use of NSAIDs (such as ibuprofen) may decrease aspirin's||
7003|179|I|ability to prevent heart attack/stroke. If you are using low-dose||
7003|180|I|aspirin for prevention of heart attack/stroke, consult your||
7003|181|I|doctor or pharmacist for more details and to discuss other||
7003|182|I|possible treatments (such as acetaminophen) for your pain/fever.||
7003|183|I|   This medication may interfere with certain lab tests (such as||
7003|184|I|certain urine sugar tests), possibly causing false test results.||
7003|185|I|Make sure lab personnel and all your doctors know you use this||
7003|186|I|drug.||
7003|187|B|||
7003|188|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7003|189|O|has overdosed and has serious symptoms such as passing out or||
7003|190|O|trouble breathing, call 911. Otherwise, call a poison control||
7003|191|O|center right away. US residents can call 1-800-222-1222. Canada||
7003|192|O|residents can call 1-844-764-7669. Symptoms of overdose may||
7003|193|O|include: burning pain in the throat/stomach, confusion,||
7003|194|O|mental/mood changes, fainting, weakness, ringing in the ears,||
7003|195|O|fever, rapid breathing, change in the amount of urine, seizures,||
7003|196|O|loss of consciousness.||
7003|197|B|||
7003|198|N|NOTES:  Do not share this medication with others.||
7003|199|N|   If you use this medication regularly or at high doses, lab||
7003|200|N|and/or medical tests (such as liver/kidney function, blood count,||
7003|201|N|salicylate level) may be done while you are using this||
7003|202|N|medication. Keep all medical and lab appointments. Consult your||
7003|203|N|doctor for more details.||
7003|204|N|   There are many different dosage forms for aspirin products.||
7003|205|N|Ask your doctor or pharmacist for recommendations on the best||
7003|206|N|product for you.||
7003|207|B|||
7003|208|D|MISSED DOSE:  If you are prescribed this drug on a regular||
7003|209|D|schedule (not just "as needed") and you miss a dose, use it as||
7003|210|D|soon as you remember. If it is near the time of the next dose,||
7003|211|D|skip the missed dose. Use your next dose at the regular time. Do||
7003|212|D|not double the dose to catch up.||
7003|213|B|||
7003|214|R|STORAGE:  Store in the refrigerator or in a cool place. Do not||
7003|215|R|use any aspirin product that has a strong vinegar-like smell.||
7003|216|R|Keep all medications away from children and pets.||
7003|217|R|   Do not flush medications down the toilet or pour them into a||
7003|218|R|drain unless instructed to do so. Properly discard this product||
7003|219|R|when it is expired or no longer needed. Consult your pharmacist||
7003|220|R|or local waste disposal company.||
7003|221|B|||
7003|222|A|Information last revised November 2025.||
7003|223|A|Copyright(c) 2025 First Databank, Inc.||
7003|224|B|||
7004|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7004|002|Z|does NOT have all possible information about this product. This||
7004|003|Z|information does not assure that this product is safe, effective,||
7004|004|Z|or appropriate for you. This information is not individual||
7004|005|Z|medical advice and does not substitute for the advice of your||
7004|006|Z|health care professional. Always ask your health care||
7004|007|Z|professional for complete information about this product and your||
7004|008|Z|specific health needs.||
7004|009|B|||
7004|010|T|GLYCOPYRROLATE - ORAL||
7004|011|F|(GLYE-koe-PIR-oh-late)||
7004|012|B|||
7004|013|C|COMMON BRAND NAME(S): Robinul||
7004|014|B|||
7004|015|U|USES:  Glycopyrrolate is used with other drugs to treat a certain||
7004|016|U|type of stomach/intestinal ulcer (peptic ulcer). This medication||
7004|017|U|may help relieve stomach/abdominal pain. However, it has not been||
7004|018|U|shown to be effective in healing these ulcers, preventing them||
7004|019|U|from returning, or preventing other problems caused by ulcers.||
7004|020|U|Glycopyrrolate works by decreasing the amount of acid in the||
7004|021|U|stomach. It also slows the natural movements of the gut and||
7004|022|U|relaxes the muscles in the stomach/intestines. Glycopyrrolate||
7004|023|U|belongs to a class of drugs known as anticholinergics.||
7004|024|B|||
7004|025|H|HOW TO USE:  Take this medication by mouth as directed by your||
7004|026|H|doctor, usually 2 to 3 times a day. The dosage is based on your||
7004|027|H|medical condition and response to treatment.||
7004|028|H|   Do not increase your dose or take this drug more often without||
7004|029|H|your doctor's approval. Your condition will not improve any||
7004|030|H|faster and the risk of serious side effects may increase.||
7004|031|H|   Tell your doctor if your condition lasts or gets worse.||
7004|032|B|||
7004|033|S|SIDE EFFECTS:  Drowsiness, dizziness, weakness, blurred vision,||
7004|034|S|dry eyes, dry mouth, or constipation may occur. If any of these||
7004|035|S|effects last or get worse, tell your doctor or pharmacist||
7004|036|S|promptly.||
7004|037|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
7004|038|S|chips, chew (sugarless) gum, drink water, or use a saliva||
7004|039|S|substitute. To relieve dry eyes, consult your pharmacist for||
7004|040|S|artificial tears or other eye lubricants.||
7004|041|S|   To prevent constipation, eat dietary fiber, drink enough||
7004|042|S|water, and exercise. You may also need to take a laxative. Ask||
7004|043|S|your pharmacist which type of laxative is right for you.||
7004|044|S|   Remember that this medication has been prescribed because your||
7004|045|S|doctor has judged that the benefit to you is greater than the||
7004|046|S|risk of side effects. Many people using this medication do not||
7004|047|S|have serious side effects.||
7004|048|S|   Tell your doctor right away if you have any serious side||
7004|049|S|effects, including: stomach/abdominal bloating or pain, vomiting,||
7004|050|S|diarrhea, decreased sweating, dry/hot/flushed skin,||
7004|051|S|fast/irregular heartbeat, mental/mood changes (such as confusion,||
7004|052|S|hallucinations, agitation, nervousness, unusual excitement),||
7004|053|S|difficulty urinating.||
7004|054|S|   Get medical help right away if you have any very serious side||
7004|055|S|effects, including: eye pain/swelling/redness, vision changes||
7004|056|S|(such as seeing rainbows around lights at night).||
7004|057|S|   A very serious allergic reaction to this drug is rare.||
7004|058|S|However, get medical help right away if you notice any symptoms||
7004|059|S|of a serious allergic reaction, including: rash, itching/swelling||
7004|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7004|061|S|breathing.||
7004|062|S|   This is not a complete list of possible side effects. If you||
7004|063|S|notice other effects not listed above, contact your doctor or||
7004|064|S|pharmacist.||
7004|065|S|   In the US -||
7004|066|S|   Call your doctor for medical advice about side effects. You||
7004|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7004|068|S|www.fda.gov/medwatch.||
7004|069|S|   In Canada - Call your doctor for medical advice about side||
7004|070|S|effects. You may report side effects to Health Canada at||
7004|071|S|1-866-234-2345.||
7004|072|B|||
7004|073|P|PRECAUTIONS:  Before taking glycopyrrolate, tell your doctor or||
7004|074|P|pharmacist if you are allergic to it; or if you have any other||
7004|075|P|allergies. This product may contain inactive ingredients, which||
7004|076|P|can cause allergic reactions or other problems. Talk to your||
7004|077|P|pharmacist for more details.||
7004|078|P|   Before using this medication, tell your doctor or pharmacist||
7004|079|P|your medical history, especially of: glaucoma, problems with||
7004|080|P|urination (such as due to a blockage, enlarged prostate), other||
7004|081|P|stomach/intestinal problems (such as slow gut, intestinal||
7004|082|P|blockage/infection, ulcerative colitis), myasthenia gravis,||
7004|083|P|kidney problems.||
7004|084|P|   This drug may make you dizzy or drowsy or blur your vision.||
7004|085|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7004|086|P|drowsy. Do not drive, use machinery, or do anything that needs||
7004|087|P|alertness or clear vision until you can do it safely. Limit||
7004|088|P|alcoholic beverages. Talk to your doctor if you are using||
7004|089|P|marijuana (cannabis).||
7004|090|P|   This medication may make you sweat less, making you more||
7004|091|P|likely to get heat stroke. Avoid doing things that may cause you||
7004|092|P|to overheat, such as hard work or exercise in hot weather, or||
7004|093|P|using hot tubs. When the weather is hot, drink a lot of fluids||
7004|094|P|and dress lightly. If you overheat, quickly look for a place to||
7004|095|P|cool down and rest. Get medical help right away if you have a||
7004|096|P|fever that does not go away, mental/mood changes, headache, or||
7004|097|P|dizziness.||
7004|098|P|   Older adults may be more sensitive to the side effects of this||
7004|099|P|drug, especially drowsiness, confusion, unusual excitement,||
7004|100|P|constipation, and urination problems.||
7004|101|P|   During pregnancy, this medication should be used only when||
7004|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
7004|103|P|   It is unknown if this drug passes into breast milk. Consult||
7004|104|P|your doctor before breastfeeding.||
7004|105|B|||
7004|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7004|107|I|medications work or increase your risk for serious side effects.||
7004|108|I|This document does not contain all possible drug interactions.||
7004|109|I|Keep a list of all the products you use (including||
7004|110|I|prescription/nonprescription drugs and herbal products) and share||
7004|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
7004|112|I|the dosage of any medicines without your doctor's approval.||
7004|113|I|   Some products that may interact with this drug include:||
7004|114|I|potassium tablets/capsules, drugs that are affected by slowed gut||
7004|115|I|movement (such as pramlintide).||
7004|116|I|   Tell your doctor or pharmacist if you are taking other||
7004|117|I|products that cause drowsiness including alcohol, marijuana||
7004|118|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
7004|119|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
7004|120|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
7004|121|I|codeine).||
7004|122|I|   Check the labels on all your medicines (such as allergy or||
7004|123|I|cough-and-cold products, diet aids) because they may contain||
7004|124|I|ingredients that cause drowsiness or a fast heartbeat. Ask your||
7004|125|I|pharmacist about using those products safely.||
7004|126|I|   This medication may interfere with certain lab tests (such as||
7004|127|I|gastric secretion tests), possibly causing false test results.||
7004|128|I|Make sure lab personnel and all your doctors know you use this||
7004|129|I|drug.||
7004|130|B|||
7004|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7004|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7004|133|O|poison control center right away. US residents can call||
7004|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7004|135|O|Symptoms of overdose may include: hot/dry skin, fever, severe||
7004|136|O|dizziness, mental/mood changes (such as confusion, unusual||
7004|137|O|excitement), fast/irregular heartbeat, muscle weakness, seizures.||
7004|138|B|||
7004|139|N|NOTES:  Do not share this medication with others.||
7004|140|N|   Lab and/or medical tests (such as stomach/intestinal exams)||
7004|141|N|should be done while you are taking this medication. Keep all||
7004|142|N|medical and lab appointments.||
7004|143|B|||
7004|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7004|145|D|remember. If it is near the time of the next dose, skip the||
7004|146|D|missed dose. Take your next dose at the regular time. Do not||
7004|147|D|double the dose to catch up.||
7004|148|B|||
7004|149|R|STORAGE:  Store at room temperature away from light and moisture.||
7004|150|R|Do not store in the bathroom. Keep all medications away from||
7004|151|R|children and pets.||
7004|152|R|   Do not flush medications down the toilet or pour them into a||
7004|153|R|drain unless instructed to do so. Properly discard this product||
7004|154|R|when it is expired or no longer needed. Consult your pharmacist||
7004|155|R|or local waste disposal company.||
7004|156|B|||
7004|157|A|Information last revised May 2024.||
7004|158|A|Copyright(c) 2025 First Databank, Inc.||
7004|159|B|||
7006|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7006|002|Z|does NOT have all possible information about this product. This||
7006|003|Z|information does not assure that this product is safe, effective,||
7006|004|Z|or appropriate for you. This information is not individual||
7006|005|Z|medical advice and does not substitute for the advice of your||
7006|006|Z|health care professional. Always ask your health care||
7006|007|Z|professional for complete information about this product and your||
7006|008|Z|specific health needs.||
7006|009|B|||
7006|010|T|FLURAZEPAM - ORAL||
7006|011|F|(flur-AZ-e-pam)||
7006|012|B|||
7006|013|C|COMMON BRAND NAME(S): Dalmane||
7006|014|B|||
7006|015|W|WARNING:  Flurazepam has a risk for abuse and addiction, which||
7006|016|W|can lead to overdose and death. Taking this medication with||
7006|017|W|alcohol or other drugs that can cause drowsiness or breathing||
7006|018|W|problems (especially opioid medications such as codeine,||
7006|019|W|hydrocodone) may cause very serious side effects, including||
7006|020|W|death. To lower your risk, your doctor should have you take the||
7006|021|W|smallest dose of flurazepam that works, and take it for the||
7006|022|W|shortest possible time. Be sure you know how to take flurazepam||
7006|023|W|and what other drugs you should avoid taking with it. See also||
7006|024|W|Drug Interactions section. Get medical help right away if any of||
7006|025|W|these very serious side effects occur: slow/shallow breathing,||
7006|026|W|unusual lightheadedness, severe drowsiness/dizziness, difficulty||
7006|027|W|waking up.||
7006|028|W|   Suddenly stopping this medication may cause serious (possibly||
7006|029|W|fatal) withdrawal, especially if you have used it for a long time||
7006|030|W|or in high doses. To prevent withdrawal, your doctor may lower||
7006|031|W|your dose slowly. Tell your doctor or pharmacist right away if||
7006|032|W|you have any withdrawal symptoms such as headaches, restlessness,||
7006|033|W|hallucinations/confusion, depression, nausea, or seizures.||
7006|034|W|Withdrawal symptoms may sometimes last weeks to months.||
7006|035|B|||
7006|036|U|USES:  This medication is used to treat a certain sleep problem||
7006|037|U|(insomnia). It may help you fall asleep faster, stay asleep||
7006|038|U|longer, and lessen how often you wake up during the night, so you||
7006|039|U|can get a better night's rest. Flurazepam belongs to a class of||
7006|040|U|drugs called benzodiazepines. It acts on your brain to produce a||
7006|041|U|calming effect.||
7006|042|U|   Use of this medication is usually limited to treatment periods||
7006|043|U|of 1 to 2 weeks or less. If your insomnia continues for a longer||
7006|044|U|time, talk to your doctor to see if you need other treatment.||
7006|045|B|||
7006|046|H|HOW TO USE:  See also Warning section.||
7006|047|H|   Read the Medication Guide provided by your pharmacist before||
7006|048|H|you start taking flurazepam and each time you get a refill. If||
7006|049|H|you have any questions, ask your doctor or pharmacist.||
7006|050|H|   Take this medication by mouth with or without food as directed||
7006|051|H|by your doctor, usually just before you get into bed. The dosage||
7006|052|H|is based on your medical condition, age, and response to||
7006|053|H|treatment.||
7006|054|H|   Although unlikely, this drug can rarely cause temporary||
7006|055|H|short-term memory loss. To lessen the chance of this, do not take||
7006|056|H|a dose of this drug unless you have time for a full night's sleep||
7006|057|H|of at least 7 to 8 hours. If you have to wake up before that, you||
7006|058|H|may have some memory loss.||
7006|059|H|   When this medication is used for a long time, it may not work||
7006|060|H|as well. Talk with your doctor if this medication stops working||
7006|061|H|well.||
7006|062|H|   Though it helps many people, this medication may sometimes||
7006|063|H|cause addiction. This risk may be higher if you have a substance||
7006|064|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
7006|065|H|Take this medication exactly as prescribed to lower the risk of||
7006|066|H|addiction. Ask your doctor or pharmacist for more details.||
7006|067|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
7006|068|H|or if it gets worse.||
7006|069|H|   You may have trouble sleeping the first few nights after you||
7006|070|H|stop taking this medication. This is called rebound insomnia and||
7006|071|H|is normal. It will usually go away after 1 or 2 nights. If this||
7006|072|H|effect continues, contact your doctor.||
7006|073|B|||
7006|074|S|SIDE EFFECTS:  See also Warning section.||
7006|075|S|   Dizziness or difficulty with coordination may occur. If either||
7006|076|S|of these effects lasts or gets worse, tell your doctor or||
7006|077|S|pharmacist promptly. To reduce the risk of dizziness or falling,||
7006|078|S|get up slowly when rising from a sitting or lying position.||
7006|079|S|   This medication may make you sleepy during the day. Tell your||
7006|080|S|doctor if you have daytime drowsiness. Your dose may need to be||
7006|081|S|adjusted.||
7006|082|S|   Remember that this medication has been prescribed because your||
7006|083|S|doctor has judged that the benefit to you is greater than the||
7006|084|S|risk of side effects. Many people using this medication do not||
7006|085|S|have serious side effects.||
7006|086|S|   Tell your doctor right away if you have any serious side||
7006|087|S|effects, including: memory loss, mental/mood/behavior changes||
7006|088|S|(such as new/worsening depression, abnormal thoughts, thoughts of||
7006|089|S|suicide, hallucinations, confusion, agitation, aggressive||
7006|090|S|behavior, anxiety).||
7006|091|S|   Rarely, after taking this drug, people have gotten out of bed||
7006|092|S|and driven vehicles while not fully awake ("sleep-driving").||
7006|093|S|People have also sleepwalked, prepared/eaten food, made phone||
7006|094|S|calls, or had sex while not fully awake. Often, these people do||
7006|095|S|not remember these events. This problem can be dangerous to you||
7006|096|S|or to others. If you find out that you have done any of these||
7006|097|S|activities after taking this medication, tell your doctor right||
7006|098|S|away. Your risk is increased if you use alcohol or other||
7006|099|S|medications that can make you drowsy while taking flurazepam.||
7006|100|S|   A very serious allergic reaction to this drug is rare.||
7006|101|S|However, get medical help right away if you notice any symptoms||
7006|102|S|of a serious allergic reaction, including: rash, itching/swelling||
7006|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7006|104|S|breathing.||
7006|105|S|   This is not a complete list of possible side effects. If you||
7006|106|S|notice other effects not listed above, contact your doctor or||
7006|107|S|pharmacist.||
7006|108|S|   In the US -||
7006|109|S|   Call your doctor for medical advice about side effects. You||
7006|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7006|111|S|www.fda.gov/medwatch.||
7006|112|S|   In Canada - Call your doctor for medical advice about side||
7006|113|S|effects. You may report side effects to Health Canada at||
7006|114|S|1-866-234-2345.||
7006|115|B|||
7006|116|P|PRECAUTIONS:  Before taking flurazepam, tell your doctor or||
7006|117|P|pharmacist if you are allergic to it; or to other benzodiazepines||
7006|118|P|(such as diazepam, lorazepam); or if you have any other||
7006|119|P|allergies. This product may contain inactive ingredients, which||
7006|120|P|can cause allergic reactions or other problems. Talk to your||
7006|121|P|pharmacist for more details.||
7006|122|P|   Before using this medication, tell your doctor or pharmacist||
7006|123|P|your medical history, especially of: kidney disease, liver||
7006|124|P|disease, lung/breathing problems (such as chronic obstructive||
7006|125|P|pulmonary disease-COPD, sleep apnea), mental/mood problems (such||
7006|126|P|as depression, thoughts of suicide), personal or family history||
7006|127|P|of a substance use disorder (such as overuse of or addiction to||
7006|128|P|drugs/alcohol), personal or family history of sleepwalking, a||
7006|129|P|certain muscle disease (myasthenia gravis).||
7006|130|P|   Since this drug makes you drowsy, do not drive, use machinery,||
7006|131|P|or do anything that needs alertness until you can do it safely.||
7006|132|P|Alcohol or marijuana (cannabis) can make you more drowsy. Avoid||
7006|133|P|alcoholic beverages. Talk to your doctor if you are using||
7006|134|P|marijuana (cannabis).||
7006|135|P|   Before having surgery, tell your doctor or dentist about all||
7006|136|P|the products you use (including prescription drugs,||
7006|137|P|nonprescription drugs, and herbal products).||
7006|138|P|   Older adults may be more sensitive to the side effects of this||
7006|139|P|drug, especially dizziness, confusion, unsteadiness, and||
7006|140|P|excessive drowsiness. These side effects can increase the risk of||
7006|141|P|falling.||
7006|142|P|   Flurazepam must not be used during pregnancy. It may harm an||
7006|143|P|unborn baby. If you are a woman of childbearing age, use a||
7006|144|P|reliable form of birth control while taking this drug. If you are||
7006|145|P|planning pregnancy, do not take this medication. If you become||
7006|146|P|pregnant or think you may be pregnant, tell your doctor right||
7006|147|P|away.||
7006|148|P|   This medication may pass into breast milk and have undesirable||
7006|149|P|effects on a nursing infant. Consult your doctor before||
7006|150|P|breastfeeding.||
7006|151|B|||
7006|152|I|DRUG INTERACTIONS:  See also Warning section.||
7006|153|I|   Drug interactions may change how your medications work or||
7006|154|I|increase your risk for serious side effects. This document does||
7006|155|I|not contain all possible drug interactions. Keep a list of all||
7006|156|I|the products you use (including prescription/nonprescription||
7006|157|I|drugs and herbal products) and share it with your doctor and||
7006|158|I|pharmacist. Do not start, stop, or change the dosage of any||
7006|159|I|medicines without your doctor's approval.||
7006|160|I|   A product that may interact with this drug is: sodium oxybate.||
7006|161|I|   The risk of serious side effects (such as slow/shallow||
7006|162|I|breathing, severe drowsiness/dizziness) may be increased if this||
7006|163|I|medication is taken with other products that may also cause||
7006|164|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
7006|165|I|if you are taking other products such as opioid pain or cough||
7006|166|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7006|167|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
7006|168|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7006|169|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7006|170|I|diphenhydramine).||
7006|171|I|   Check the labels on all your medicines (such as allergy or||
7006|172|I|cough-and-cold products) because they may contain ingredients||
7006|173|I|that cause drowsiness. Ask your pharmacist about using those||
7006|174|I|products safely.||
7006|175|B|||
7006|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7006|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7006|178|O|poison control center right away. US residents can call||
7006|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7006|180|O|Symptoms of overdose may include slowed breathing or a deep sleep||
7006|181|O|from which you cannot be awakened.||
7006|182|B|||
7006|183|N|NOTES:  Do not share this medication with others. Sharing it is||
7006|184|N|against the law.||
7006|185|N|   As you get older, your sleep pattern may naturally change and||
7006|186|N|your sleep may be interrupted several times during the night.||
7006|187|N|Consult your doctor or pharmacist for ways to improve your sleep||
7006|188|N|without medication, such as avoiding caffeine and alcohol close||
7006|189|N|to bedtime, avoiding daytime naps, and going to bed at the same||
7006|190|N|time each night.||
7006|191|B|||
7006|192|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
7006|193|D|time to sleep for 7 to 8 hours afterward. (See also How to Use||
7006|194|D|section.)||
7006|195|B|||
7006|196|R|STORAGE:  Store at room temperature away from light and moisture.||
7006|197|R|Do not store in the bathroom. Keep all medications away from||
7006|198|R|children and pets.||
7006|199|R|   Do not flush medications down the toilet or pour them into a||
7006|200|R|drain unless instructed to do so. Properly discard this product||
7006|201|R|when it is expired or no longer needed. Consult your pharmacist||
7006|202|R|or local waste disposal company.||
7006|203|B|||
7006|204|A|Information last revised May 2024.||
7006|205|A|Copyright(c) 2025 First Databank, Inc.||
7006|206|B|||
7010|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7010|002|Z|does NOT have all possible information about this product. This||
7010|003|Z|information does not assure that this product is safe, effective,||
7010|004|Z|or appropriate for you. This information is not individual||
7010|005|Z|medical advice and does not substitute for the advice of your||
7010|006|Z|health care professional. Always ask your health care||
7010|007|Z|professional for complete information about this product and your||
7010|008|Z|specific health needs.||
7010|009|B|||
7010|010|T|VERAPAMIL EXTENDED-RELEASE - ORAL||
7010|011|F|(ver-AP-a-mil)||
7010|012|B|||
7010|013|C|COMMON BRAND NAME(S): Calan SR, Isoptin SR||
7010|014|B|||
7010|015|U|USES:  Verapamil is used to treat high blood pressure. Lowering||
7010|016|U|high blood pressure helps prevent strokes, heart attacks, and||
7010|017|U|kidney problems. Verapamil belongs to a class of drugs known as||
7010|018|U|calcium channel blockers. It works by relaxing blood vessels so||
7010|019|U|blood can flow more easily. Verapamil may also lower your heart||
7010|020|U|rate.||
7010|021|B|||
7010|022|V|OTHER USES:  This section contains uses of this drug that are not||
7010|023|V|listed in the approved professional labeling for the drug but||
7010|024|V|that may be prescribed by your health care professional. Use this||
7010|025|V|drug for a condition that is listed in this section only if it||
7010|026|V|has been so prescribed by your health care professional.||
7010|027|V|   This drug may also be used for other heart diseases (such as||
7010|028|V|hypertrophic cardiomyopathy, fast/irregular heartbeats). It may||
7010|029|V|also be used to reduce the risk of chest pain (angina).||
7010|030|B|||
7010|031|H|HOW TO USE:  Take this medication by mouth with food as directed||
7010|032|H|by your doctor, usually once daily in the morning or every 12||
7010|033|H|hours.||
7010|034|H|   Do not crush or chew extended-release tablets. Doing so can||
7010|035|H|release all of the drug at once, increasing the risk of side||
7010|036|H|effects. Ask your pharmacist if the tablets may be split in half,||
7010|037|H|because the directions depend on the product you take. Swallow||
7010|038|H|the whole or split tablet without crushing or chewing.||
7010|039|H|   The dosage is based on your medical condition and response to||
7010|040|H|treatment.||
7010|041|H|   Take this medication regularly to get the most benefit from||
7010|042|H|it. To help you remember, take it at the same time(s) each day.||
7010|043|H|Keep taking this medication even if you feel well. Most people||
7010|044|H|with high blood pressure do not feel sick.||
7010|045|H|   Do not stop taking this medication without consulting your||
7010|046|H|doctor. Some conditions may become worse when this drug is||
7010|047|H|suddenly stopped. Your dose may need to be gradually decreased.||
7010|048|H|   For the treatment of high blood pressure, it may take a week||
7010|049|H|before you get the full benefit of this drug.||
7010|050|H|   Tell your doctor if your condition does not get better or if||
7010|051|H|it gets worse (your blood pressure readings remain high or||
7010|052|H|increase).||
7010|053|B|||
7010|054|S|SIDE EFFECTS:  Dizziness, slow heartbeat, constipation, nausea,||
7010|055|S|headache, or tiredness may occur. If any of these effects last or||
7010|056|S|get worse, tell your doctor or pharmacist promptly.||
7010|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
7010|058|S|slowly when rising from a sitting or lying position.||
7010|059|S|   Remember that this medication has been prescribed because your||
7010|060|S|doctor has judged that the benefit to you is greater than the||
7010|061|S|risk of side effects. Many people using this medication do not||
7010|062|S|have serious side effects.||
7010|063|S|   Tell your doctor right away if you have any serious side||
7010|064|S|effects, including: severe dizziness, fainting, new or worsening||
7010|065|S|symptoms of heart failure (such as shortness of breath, swelling||
7010|066|S|ankles/feet, unusual tiredness, unusual/sudden weight gain), very||
7010|067|S|slow heartbeat.||
7010|068|S|   This drug may rarely cause serious (possibly fatal) liver||
7010|069|S|disease. Get medical help right away if you have any symptoms of||
7010|070|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
7010|071|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
7010|072|S|urine.||
7010|073|S|   A very serious allergic reaction to this drug is rare.||
7010|074|S|However, get medical help right away if you notice any symptoms||
7010|075|S|of a serious allergic reaction, including: rash, itching/swelling||
7010|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7010|077|S|breathing.||
7010|078|S|   This is not a complete list of possible side effects. If you||
7010|079|S|notice other effects not listed above, contact your doctor or||
7010|080|S|pharmacist.||
7010|081|S|   In the US -||
7010|082|S|   Call your doctor for medical advice about side effects. You||
7010|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7010|084|S|www.fda.gov/medwatch.||
7010|085|S|   In Canada - Call your doctor for medical advice about side||
7010|086|S|effects. You may report side effects to Health Canada at||
7010|087|S|1-866-234-2345.||
7010|088|B|||
7010|089|P|PRECAUTIONS:  Before taking verapamil, tell your doctor or||
7010|090|P|pharmacist if you are allergic to it; or if you have any other||
7010|091|P|allergies. This product may contain inactive ingredients, which||
7010|092|P|can cause allergic reactions or other problems. Talk to your||
7010|093|P|pharmacist for more details.||
7010|094|P|   Before using this medication, tell your doctor or pharmacist||
7010|095|P|your medical history, especially of: certain types of heart||
7010|096|P|rhythm problems (such as second- or third-degree atrioventricular||
7010|097|P|block, sick sinus syndrome unless you have a pacemaker,||
7010|098|P|Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome),||
7010|099|P|heart failure, certain muscle/nerve disorders (muscular||
7010|100|P|dystrophy, myasthenia gravis), liver disease, kidney disease.||
7010|101|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7010|102|P|can make you more dizzy. Do not drive, use machinery, or do||
7010|103|P|anything that needs alertness until you can do it safely. Limit||
7010|104|P|alcoholic beverages. Talk to your doctor if you are using||
7010|105|P|marijuana (cannabis).||
7010|106|P|   Before having surgery, tell your doctor or dentist about all||
7010|107|P|the products you use (including prescription drugs,||
7010|108|P|nonprescription drugs, and herbal products).||
7010|109|P|   Older adults may be more sensitive to the side effects of this||
7010|110|P|drug, especially constipation, or swelling ankles/feet.||
7010|111|P|   During pregnancy, this medication should be used only when||
7010|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
7010|113|P|   This medication passes into breast milk, but is unlikely to||
7010|114|P|harm a nursing infant. Consult your doctor before breastfeeding.||
7010|115|B|||
7010|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7010|117|I|medications work or increase your risk for serious side effects.||
7010|118|I|This document does not contain all possible drug interactions.||
7010|119|I|Keep a list of all the products you use (including||
7010|120|I|prescription/nonprescription drugs and herbal products) and share||
7010|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
7010|122|I|the dosage of any medicines without your doctor's approval.||
7010|123|I|   Some products that may interact with this drug include:||
7010|124|I|aliskiren, clonidine, disopyramide, dofetilide, fingolimod,||
7010|125|I|labetalol, lithium.||
7010|126|I|   Other medications can affect the removal of verapamil from||
7010|127|I|your body, which may affect how verapamil works. Examples include||
7010|128|I|erythromycin, rifamycins (such as rifampin), ritonavir, St.||
7010|129|I|John's wort, among others.||
7010|130|I|   Verapamil can slow down the removal of other medications from||
7010|131|I|your body, which may affect how they work. Examples of affected||
7010|132|I|drugs include colchicine, elacestrant, fezolinetant, flibanserin,||
7010|133|I|ivabradine, lomitapide, midazolam, rilzabrutinib, taletrectinib,||
7010|134|I|triazolam, among others.||
7010|135|I|   Some products have ingredients that could raise your heart||
7010|136|I|rate or blood pressure. Tell your pharmacist what products you||
7010|137|I|are using, and ask how to use them safely (especially||
7010|138|I|cough-and-cold products, diet aids, or NSAIDs such as||
7010|139|I|ibuprofen/naproxen).||
7010|140|B|||
7010|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7010|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7010|143|O|poison control center right away. US residents can call||
7010|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7010|145|O|Symptoms of overdose may include: very slow heartbeat, severe||
7010|146|O|dizziness, fainting.||
7010|147|B|||
7010|148|N|NOTES:  Do not share this medication with others.||
7010|149|N|   Lifestyle changes that may help this medication work better||
7010|150|N|include exercising, stopping smoking, and eating a||
7010|151|N|low-cholesterol/low-fat diet. Consult your doctor for more||
7010|152|N|details.||
7010|153|N|   Lab and/or medical tests (such as liver function) should be||
7010|154|N|done while you are taking this medication. Keep all medical and||
7010|155|N|lab appointments. Consult your doctor for more details.||
7010|156|N|   Check your blood pressure and pulse (heart rate) regularly||
7010|157|N|while taking this medication. Learn how to check your own blood||
7010|158|N|pressure and pulse at home, and share the results with your||
7010|159|N|doctor.||
7010|160|N|   There are different brands and types of this medication||
7010|161|N|available. Some do not have the same effects. Do not change||
7010|162|N|brands or types without consulting your doctor or pharmacist.||
7010|163|B|||
7010|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7010|165|D|remember. If it is near the time of the next dose, skip the||
7010|166|D|missed dose. Take your next dose at the regular time. Do not||
7010|167|D|double the dose to catch up.||
7010|168|B|||
7010|169|R|STORAGE:  Store at room temperature away from light and moisture.||
7010|170|R|Do not store in the bathroom. Keep all medications away from||
7010|171|R|children and pets.||
7010|172|R|   Do not flush medications down the toilet or pour them into a||
7010|173|R|drain unless instructed to do so. Properly discard this product||
7010|174|R|when it is expired or no longer needed. Consult your pharmacist||
7010|175|R|or local waste disposal company.||
7010|176|B|||
7010|177|M|MEDICAL ALERT:  Your condition can cause complications in a||
7010|178|M|medical emergency. For information about enrolling in MedicAlert,||
7010|179|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7010|180|B|||
7010|181|A|Information last revised September 2025.||
7010|182|A|Copyright(c) 2025 First Databank, Inc.||
7010|183|B|||
7011|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7011|002|Z|does NOT have all possible information about this product. This||
7011|003|Z|information does not assure that this product is safe, effective,||
7011|004|Z|or appropriate for you. This information is not individual||
7011|005|Z|medical advice and does not substitute for the advice of your||
7011|006|Z|health care professional. Always ask your health care||
7011|007|Z|professional for complete information about this product and your||
7011|008|Z|specific health needs.||
7011|009|B|||
7011|010|T|CEFIXIME - ORAL||
7011|011|F|(sef-IX-eem)||
7011|012|B|||
7011|013|C|COMMON BRAND NAME(S): Suprax||
7011|014|B|||
7011|015|U|USES:  Cefixime is used to treat a wide variety of bacterial||
7011|016|U|infections. This medication is known as a cephalosporin||
7011|017|U|antibiotic. It works by stopping the growth of bacteria.||
7011|018|U|   This antibiotic treats only bacterial infections. It will not||
7011|019|U|work for viral infections (such as common cold, flu). Using any||
7011|020|U|antibiotic when it is not needed can cause it to not work for||
7011|021|U|future infections.||
7011|022|B|||
7011|023|H|HOW TO USE:  Take this medication by mouth with or without food||
7011|024|H|as directed by your doctor, usually once a day. In children, this||
7011|025|H|medication may also be taken twice a day (every 12 hours). If you||
7011|026|H|are taking the chewable tablets, chew thoroughly and then||
7011|027|H|swallow.||
7011|028|H|   The dosage is based on your medical condition and response to||
7011|029|H|treatment. Children's dosage is also based on weight.||
7011|030|H|   For the best effect, take this antibiotic at evenly spaced||
7011|031|H|times. To help you remember, take this medication at the same||
7011|032|H|time(s) every day.||
7011|033|H|   Continue to use this medication until the full prescribed||
7011|034|H|amount is finished, even if symptoms disappear after a few days.||
7011|035|H|Stopping the medication too early may result in a return of the||
7011|036|H|infection.||
7011|037|H|   Tell your doctor if your condition lasts or gets worse.||
7011|038|B|||
7011|039|S|SIDE EFFECTS:  Stomach upset/pain, diarrhea, nausea, gas,||
7011|040|S|headache, or dizziness may occur. If any of these effects last or||
7011|041|S|get worse, tell your doctor or pharmacist promptly.||
7011|042|S|   Remember that this medication has been prescribed because your||
7011|043|S|doctor has judged that the benefit to you is greater than the||
7011|044|S|risk of side effects. Many people using this medication do not||
7011|045|S|have serious side effects.||
7011|046|S|   Tell your doctor right away if you have any serious side||
7011|047|S|effects, including: nausea/vomiting that doesn't stop, severe||
7011|048|S|stomach/abdominal pain, yellowing eyes/skin, dark urine, unusual||
7011|049|S|tiredness, new signs of infection (such as sore throat that||
7011|050|S|doesn't go away, fever, chills), easy bruising/bleeding, signs of||
7011|051|S|kidney problems (such as change in the amount of urine),||
7011|052|S|mental/mood changes (such as confusion).||
7011|053|S|   This medication may rarely cause a severe intestinal condition||
7011|054|S|due to a bacteria called C. difficile. This condition may occur||
7011|055|S|during treatment or weeks to months after treatment has stopped.||
7011|056|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7011|057|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7011|058|S|stool.||
7011|059|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7011|060|S|products because they may make symptoms worse.||
7011|061|S|   Use of this medication for prolonged or repeated periods may||
7011|062|S|result in oral thrush or a new vaginal yeast infection (oral or||
7011|063|S|vaginal fungal infection). Contact your doctor if you notice||
7011|064|S|white patches in your mouth, a change in vaginal discharge, or||
7011|065|S|other new symptoms.||
7011|066|S|   A very serious allergic reaction to this drug is rare.||
7011|067|S|However, get medical help right away if you notice any symptoms||
7011|068|S|of a serious allergic reaction, including: rash, itching/swelling||
7011|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7011|070|S|breathing.||
7011|071|S|   This is not a complete list of possible side effects. If you||
7011|072|S|notice other effects not listed above, contact your doctor or||
7011|073|S|pharmacist.||
7011|074|S|   In the US -||
7011|075|S|   Call your doctor for medical advice about side effects. You||
7011|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7011|077|S|www.fda.gov/medwatch.||
7011|078|S|   In Canada - Call your doctor for medical advice about side||
7011|079|S|effects. You may report side effects to Health Canada at||
7011|080|S|1-866-234-2345.||
7011|081|B|||
7011|082|P|PRECAUTIONS:  Before taking cefixime, tell your doctor or||
7011|083|P|pharmacist if you are allergic to it; or to penicillins or other||
7011|084|P|cephalosporin antibiotics (such as cephalexin); or if you have||
7011|085|P|any other allergies. This product may contain inactive||
7011|086|P|ingredients, which can cause allergic reactions or other||
7011|087|P|problems. Talk to your pharmacist for more details.||
7011|088|P|   Before using this medication, tell your doctor or pharmacist||
7011|089|P|your medical history, especially of: kidney disease, a certain||
7011|090|P|intestinal disease (colitis).||
7011|091|P|   Cefixime may cause live bacterial vaccines (such as typhoid||
7011|092|P|vaccine) to not work well. Tell your health care professional||
7011|093|P|that you are using cefixime before having any||
7011|094|P|immunizations/vaccinations.||
7011|095|P|   Before having surgery, tell your doctor or dentist about all||
7011|096|P|the products you use (including prescription drugs,||
7011|097|P|nonprescription drugs, and herbal products).||
7011|098|P|   The chewable form of this medication may contain aspartame. If||
7011|099|P|you have phenylketonuria (PKU) or any other condition that||
7011|100|P|requires you to limit/avoid aspartame (or phenylalanine) in your||
7011|101|P|diet, ask your doctor or pharmacist about using this medication||
7011|102|P|safely.||
7011|103|P|   During pregnancy, this medication should be used only when||
7011|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
7011|105|P|   It is unknown if this medication passes into breast milk.||
7011|106|P|Consult your doctor before breastfeeding.||
7011|107|B|||
7011|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7011|109|I|medications work or increase your risk for serious side effects.||
7011|110|I|This document does not contain all possible drug interactions.||
7011|111|I|Keep a list of all the products you use (including||
7011|112|I|prescription/nonprescription drugs and herbal products) and share||
7011|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
7011|114|I|the dosage of any medicines without your doctor's approval.||
7011|115|I|   Products that may interact with this drug include: "blood||
7011|116|I|thinners" (such as warfarin).||
7011|117|I|   This medication may interfere with certain lab tests (such as||
7011|118|I|certain diabetic urine tests), possibly causing false test||
7011|119|I|results. Make sure lab personnel and all your doctors know you||
7011|120|I|use this drug.||
7011|121|B|||
7011|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7011|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7011|124|O|poison control center right away. US residents can call||
7011|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7011|126|O|Symptoms of overdose may include: severe vomiting, seizures.||
7011|127|B|||
7011|128|N|NOTES:  Do not share this medication with others.||
7011|129|N|   This medication has been prescribed for your current condition||
7011|130|N|only. Do not use it later for another infection unless your||
7011|131|N|doctor tells you to.||
7011|132|B|||
7011|133|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7011|134|D|remember. If it is near the time of the next dose, skip the||
7011|135|D|missed dose. Take your next dose at the regular time. Do not||
7011|136|D|double the dose to catch up.||
7011|137|B|||
7011|138|R|STORAGE:  Store at room temperature away from light and moisture.||
7011|139|R|Do not store in the bathroom. Keep all medications away from||
7011|140|R|children and pets.||
7011|141|R|   Do not flush medications down the toilet or pour them into a||
7011|142|R|drain unless instructed to do so. Properly discard this product||
7011|143|R|when it is expired or no longer needed. Consult your pharmacist||
7011|144|R|or local waste disposal company.||
7011|145|B|||
7011|146|A|Information last revised May 2025.||
7011|147|A|Copyright(c) 2025 First Databank, Inc.||
7011|148|B|||
7015|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7015|002|Z|does NOT have all possible information about this product. This||
7015|003|Z|information does not assure that this product is safe, effective,||
7015|004|Z|or appropriate for you. This information is not individual||
7015|005|Z|medical advice and does not substitute for the advice of your||
7015|006|Z|health care professional. Always ask your health care||
7015|007|Z|professional for complete information about this product and your||
7015|008|Z|specific health needs.||
7015|009|B|||
7015|010|T|CLARITHROMYCIN - ORAL||
7015|011|F|(kla-RITH-roe-MYE-sin)||
7015|012|B|||
7015|013|C|COMMON BRAND NAME(S): Biaxin||
7015|014|B|||
7015|015|U|USES:  Clarithromycin is used to treat a wide variety of||
7015|016|U|bacterial infections. This medication can also be used in||
7015|017|U|combination with anti-ulcer medications to treat certain types of||
7015|018|U|stomach ulcers. It may also be used to prevent certain bacterial||
7015|019|U|infections. Clarithromycin is known as a macrolide antibiotic. It||
7015|020|U|works by stopping the growth of bacteria.||
7015|021|U|   This antibiotic treats only bacterial infections. It will not||
7015|022|U|work for viral infections (such as common cold, flu). Using any||
7015|023|U|antibiotic when it is not needed can cause it to not work for||
7015|024|U|future infections.||
7015|025|B|||
7015|026|H|HOW TO USE:  Take this medication by mouth with or without food||
7015|027|H|as directed by your doctor, usually every 12 hours. If stomach||
7015|028|H|upset occurs, you may take it with food or milk.||
7015|029|H|   For the best effect, take this antibiotic at evenly spaced||
7015|030|H|times. To help you remember, take this medication at the same||
7015|031|H|time(s) every day.||
7015|032|H|   The dosage and length of treatment are based on your medical||
7015|033|H|condition and response to treatment. Children's dosage may also||
7015|034|H|be based on weight.||
7015|035|H|   If you are using this medication to treat an infection,||
7015|036|H|continue to take this medication until the full prescribed amount||
7015|037|H|is finished, even if symptoms disappear after a few days.||
7015|038|H|Stopping the medication too early may result in a return of the||
7015|039|H|infection. Tell your doctor if your condition lasts or gets||
7015|040|H|worse.||
7015|041|H|   If you are taking this medication to prevent certain bacterial||
7015|042|H|infections, take it exactly as directed by your doctor. Do not||
7015|043|H|stop taking the medication without your doctor's approval. Tell||
7015|044|H|your doctor if you develop signs of infection such as fever or||
7015|045|H|night sweats.||
7015|046|B|||
7015|047|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, headache, and changes||
7015|048|S|in taste may occur. If any of these effects last or get worse,||
7015|049|S|tell your doctor or pharmacist promptly.||
7015|050|S|   Remember that this medication has been prescribed because your||
7015|051|S|doctor has judged that the benefit to you is greater than the||
7015|052|S|risk of side effects. Many people using this medication do not||
7015|053|S|have serious side effects.||
7015|054|S|   Tell your doctor right away if you have any serious side||
7015|055|S|effects, including: signs of liver disease (such as||
7015|056|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
7015|057|S|yellowing eyes/skin, dark urine), hearing loss, mental/mood||
7015|058|S|changes, muscle weakness, eye problems (such as drooping eyelids,||
7015|059|S|blurred vision), trouble speaking.||
7015|060|S|   This medication may rarely cause a severe intestinal condition||
7015|061|S|due to a bacteria called C. difficile. This condition may occur||
7015|062|S|during treatment or weeks to months after treatment has stopped.||
7015|063|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7015|064|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7015|065|S|stool.||
7015|066|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7015|067|S|products because they may make symptoms worse.||
7015|068|S|   Use of this medication for prolonged or repeated periods may||
7015|069|S|result in oral thrush or a new yeast infection. Contact your||
7015|070|S|doctor if you notice white patches in your mouth, a change in||
7015|071|S|vaginal discharge, or other new symptoms.||
7015|072|S|   Get medical help right away if you have any very serious side||
7015|073|S|effects, including: severe dizziness, fainting, fast/irregular||
7015|074|S|heartbeat.||
7015|075|S|   A very serious allergic reaction to this drug is rare.||
7015|076|S|However, get medical help right away if you notice any symptoms||
7015|077|S|of a serious allergic reaction, including: fever that doesn't go||
7015|078|S|away, new or worsening lymph node swelling, rash,||
7015|079|S|itching/swelling (especially of the face/tongue/throat), severe||
7015|080|S|dizziness, trouble breathing.||
7015|081|S|   This is not a complete list of possible side effects. If you||
7015|082|S|notice other effects not listed above, contact your doctor or||
7015|083|S|pharmacist.||
7015|084|S|   In the US -||
7015|085|S|   Call your doctor for medical advice about side effects. You||
7015|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7015|087|S|www.fda.gov/medwatch.||
7015|088|S|   In Canada - Call your doctor for medical advice about side||
7015|089|S|effects. You may report side effects to Health Canada at||
7015|090|S|1-866-234-2345.||
7015|091|B|||
7015|092|P|PRECAUTIONS:  Before taking clarithromycin, tell your doctor or||
7015|093|P|pharmacist if you are allergic to it; or to other macrolide||
7015|094|P|antibiotics (such as erythromycin, azithromycin); or if you have||
7015|095|P|any other allergies. This product may contain inactive||
7015|096|P|ingredients, which can cause allergic reactions or other||
7015|097|P|problems. Talk to your pharmacist for more details.||
7015|098|P|   Before using this medication, tell your doctor or pharmacist||
7015|099|P|your medical history, especially of: liver disease (including||
7015|100|P|liver problems with past clarithromycin use), kidney disease,||
7015|101|P|heart disease (coronary artery disease, heart attack), a certain||
7015|102|P|type of muscle disease (myasthenia gravis).||
7015|103|P|   Clarithromycin may cause a condition that affects the heart||
7015|104|P|rhythm (QT prolongation). QT prolongation can rarely cause||
7015|105|P|serious (rarely fatal) fast/irregular heartbeat and other||
7015|106|P|symptoms (such as severe dizziness, fainting) that need medical||
7015|107|P|attention right away.||
7015|108|P|   The risk of QT prolongation may be increased if you have||
7015|109|P|certain medical conditions or are taking other drugs that may||
7015|110|P|cause QT prolongation. Before using clarithromycin, tell your||
7015|111|P|doctor or pharmacist of all the drugs you take and if you have||
7015|112|P|any of the following conditions: certain heart problems (heart||
7015|113|P|failure, slow heartbeat, QT prolongation in the EKG), family||
7015|114|P|history of certain heart problems (QT prolongation in the EKG,||
7015|115|P|sudden cardiac death).||
7015|116|P|   Low levels of potassium or magnesium in the blood may also||
7015|117|P|increase your risk of QT prolongation. This risk may increase if||
7015|118|P|you use certain drugs (such as diuretics/"water pills") or if you||
7015|119|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7015|120|P|Talk to your doctor about using clarithromycin safely.||
7015|121|P|   Clarithromycin may cause live bacterial vaccines (such as||
7015|122|P|typhoid vaccine) to not work well. Tell your health care||
7015|123|P|professional that you are using clarithromycin before having any||
7015|124|P|immunizations/vaccinations.||
7015|125|P|   Before having surgery, tell your doctor or dentist about all||
7015|126|P|the products you use (including prescription drugs,||
7015|127|P|nonprescription drugs, and herbal products).||
7015|128|P|   Older adults may be more sensitive to the side effects of this||
7015|129|P|drug, especially hearing loss and QT prolongation (see above).||
7015|130|P|   During pregnancy, this medication should be used only when||
7015|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
7015|132|P|   This medication passes into breast milk. Consult your doctor||
7015|133|P|before breastfeeding.||
7015|134|B|||
7015|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7015|136|I|medications work or increase your risk for serious side effects.||
7015|137|I|This document does not contain all possible drug interactions.||
7015|138|I|Keep a list of all the products you use (including||
7015|139|I|prescription/nonprescription drugs and herbal products) and share||
7015|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
7015|141|I|the dosage of any medicines without your doctor's approval.||
7015|142|I|   Many drugs besides clarithromycin may affect the heart rhythm||
7015|143|I|(QT prolongation), including amiodarone, disopyramide,||
7015|144|I|dofetilide, pacritinib, pimozide, procainamide, quinidine,||
7015|145|I|sotalol, among others.||
7015|146|I|   Other medications can affect the removal of clarithromycin||
7015|147|I|from your body, which may affect how clarithromycin works.||
7015|148|I|Examples include efavirenz, nevirapine, posaconazole, rifamycins||
7015|149|I|(such as rifabutin), among others.||
7015|150|I|   Clarithromycin can slow down the removal of other medications||
7015|151|I|from your body, which may affect how they work. Examples of||
7015|152|I|affected drugs include colchicine, digoxin, some drugs used to||
7015|153|I|treat erectile dysfunction-ED/pulmonary hypertension (such as||
7015|154|I|sildenafil, tadalafil), ergot alkaloids (such as ergotamine,||
7015|155|I|dihydroergotamine), flibanserin, some statin drugs (such as||
7015|156|I|lovastatin, simvastatin), tamsulosin, tolvaptan, ticagrelor,||
7015|157|I|among others.||
7015|158|B|||
7015|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7015|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7015|161|O|poison control center right away. US residents can call||
7015|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7015|163|B|||
7015|164|N|NOTES:  Do not share this medication with others.||
7015|165|N|   This medication has been prescribed for your current condition||
7015|166|N|only. Do not use it later for another infection unless your||
7015|167|N|doctor tells you to.||
7015|168|N|   Lab and/or medical tests (such as cultures, liver/kidney||
7015|169|N|function) may be done while you are taking this medication. Keep||
7015|170|N|all medical and lab appointments. Consult your doctor for more||
7015|171|N|details.||
7015|172|B|||
7015|173|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7015|174|D|remember. If it is near the time of the next dose, skip the||
7015|175|D|missed dose. Take your next dose at the regular time. Do not||
7015|176|D|double the dose to catch up.||
7015|177|B|||
7015|178|R|STORAGE:  Store at room temperature away from light and moisture.||
7015|179|R|Do not store in the bathroom. Keep all medications away from||
7015|180|R|children and pets.||
7015|181|R|   Do not flush medications down the toilet or pour them into a||
7015|182|R|drain unless instructed to do so. Properly discard this product||
7015|183|R|when it is expired or no longer needed. Consult your pharmacist||
7015|184|R|or local waste disposal company.||
7015|185|B|||
7015|186|A|Information last revised May 2025.||
7015|187|A|Copyright(c) 2025 First Databank, Inc.||
7015|188|B|||
7016|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7016|002|Z|does NOT have all possible information about this product. This||
7016|003|Z|information does not assure that this product is safe, effective,||
7016|004|Z|or appropriate for you. This information is not individual||
7016|005|Z|medical advice and does not substitute for the advice of your||
7016|006|Z|health care professional. Always ask your health care||
7016|007|Z|professional for complete information about this product and your||
7016|008|Z|specific health needs.||
7016|009|B|||
7016|010|T|CLINDAMYCIN CREAM - VAGINAL||
7016|011|F|(KLIN-da-MYE-sin)||
7016|012|B|||
7016|013|C|COMMON BRAND NAME(S): Cleocin||
7016|014|B|||
7016|015|U|USES:  This medication is used to treat a certain type of vaginal||
7016|016|U|infection (bacterial vaginosis). Clindamycin is an antibiotic||
7016|017|U|that works by stopping the growth of bacteria. See the||
7016|018|U|Precautions section for information about use during pregnancy.||
7016|019|B|||
7016|020|H|HOW TO USE:  Read the Patient Information Leaflet for||
7016|021|H|instructions on the proper use of this medication. Consult your||
7016|022|H|doctor or pharmacist if you have any questions.||
7016|023|H|   This product is for vaginal use only. Wash your hands before||
7016|024|H|and after each application. Avoid contact of this cream with your||
7016|025|H|eyes. If it gets into your eyes, wash them right away with plenty||
7016|026|H|of water. Call your doctor if eye irritation lasts.||
7016|027|H|   Fill the applicator with the cream according to the||
7016|028|H|directions. Insert the applicator high into the vagina and press||
7016|029|H|the plunger to release the medication. Use this product as||
7016|030|H|directed by your doctor, usually once a day at bedtime. If you||
7016|031|H|have extra applicators, discard each one after use. If you have||
7016|032|H|only one applicator, clean it with warm soapy water and rinse||
7016|033|H|well. Do not boil or use hot water to clean the applicator.||
7016|034|H|   To prevent medication from leaking out of the vagina, lie down||
7016|035|H|as soon as possible after use.||
7016|036|H|   Antibiotics work best when the amount of medicine in your body||
7016|037|H|is kept at a constant level. Use this drug at evenly spaced||
7016|038|H|intervals.||
7016|039|H|   Continue to use this medication for the full time prescribed,||
7016|040|H|even if symptoms disappear after a few days. Stopping the||
7016|041|H|medication too early may result in a return of the infection.||
7016|042|H|   Tell your doctor if your condition lasts or gets worse.||
7016|043|B|||
7016|044|S|SIDE EFFECTS:  Mild diarrhea or stomach upset may occur. If any||
7016|045|S|of these effects last or get worse, tell your doctor or||
7016|046|S|pharmacist promptly.||
7016|047|S|   Although unlikely, vaginal pain/burning/itching/discharge may||
7016|048|S|occur or worsen. These symptoms may be due to a new vaginal||
7016|049|S|infection (such as a yeast/fungal infection, trichomonas||
7016|050|S|infection). This medication may rarely cause a fungal infection||
7016|051|S|in another part of your body (such as oral thrush). Contact your||
7016|052|S|doctor if you notice a change in vaginal discharge, white patches||
7016|053|S|in your mouth, or other new symptoms.||
7016|054|S|   Remember that this medication has been prescribed because your||
7016|055|S|doctor has judged that the benefit to you is greater than the||
7016|056|S|risk of side effects. Many people using this medication do not||
7016|057|S|have serious side effects.||
7016|058|S|   Tell your doctor right away if you have any serious side||
7016|059|S|effects, including: pain when you urinate, lower back pain,||
7016|060|S|menstrual problems, abnormal vaginal bleeding.||
7016|061|S|   A very small amount of this medication may be absorbed into||
7016|062|S|your blood and may rarely cause a severe intestinal condition due||
7016|063|S|to a bacteria called C. difficile. This condition may occur||
7016|064|S|during treatment or weeks to months after treatment has stopped.||
7016|065|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7016|066|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7016|067|S|stool.||
7016|068|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7016|069|S|products because they may make symptoms worse.||
7016|070|S|   A very serious allergic reaction to this drug is rare.||
7016|071|S|However, get medical help right away if you notice any symptoms||
7016|072|S|of a serious allergic reaction, including: rash, itching/swelling||
7016|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7016|074|S|breathing.||
7016|075|S|   This is not a complete list of possible side effects. If you||
7016|076|S|notice other effects not listed above, contact your doctor or||
7016|077|S|pharmacist.||
7016|078|S|   In the US -||
7016|079|S|   Call your doctor for medical advice about side effects. You||
7016|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7016|081|S|www.fda.gov/medwatch.||
7016|082|S|   In Canada - Call your doctor for medical advice about side||
7016|083|S|effects. You may report side effects to Health Canada at||
7016|084|S|1-866-234-2345.||
7016|085|B|||
7016|086|P|PRECAUTIONS:  Before using clindamycin, tell your doctor or||
7016|087|P|pharmacist if you are allergic to it; or to lincomycin; or if you||
7016|088|P|have any other allergies. This product may contain inactive||
7016|089|P|ingredients, which can cause allergic reactions or other||
7016|090|P|problems. Talk to your pharmacist for more details.||
7016|091|P|   Before using this medication, tell your doctor or pharmacist||
7016|092|P|your medical history, especially of: intestinal diseases (such as||
7016|093|P|C. difficile-associated diarrhea, enteritis, ulcerative colitis).||
7016|094|P|   Do not have vaginal intercourse or use tampons or douches||
7016|095|P|while using this medication because these can cause the cream to||
7016|096|P|not work as well.||
7016|097|P|   The mineral oil in this product can weaken rubber products||
7016|098|P|such as latex condoms and diaphragms and lead to their failure.||
7016|099|P|Do not use these products during treatment with this medication||
7016|100|P|and for 72 hours after treatment is over. Consult your doctor||
7016|101|P|about other forms of barrier protection/birth control (such as||
7016|102|P|polyurethane condoms) during this time.||
7016|103|P|   Before having surgery, tell your doctor or dentist about all||
7016|104|P|the products you use (including prescription drugs,||
7016|105|P|nonprescription drugs, and herbal products).||
7016|106|P|   During pregnancy, this medication should be used only when||
7016|107|P|clearly needed. Oral antibiotics have been used to treat vaginal||
7016|108|P|infections during pregnancy, especially high-risk pregnancies||
7016|109|P|(such as pregnancies with a risk of early childbirth). Consult||
7016|110|P|your doctor for more details and to discuss the risks and||
7016|111|P|benefits.||
7016|112|P|   It is unknown if the medication in this product passes into||
7016|113|P|breast milk. Consult your doctor before breastfeeding.||
7016|114|B|||
7016|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7016|116|I|medications work or increase your risk for serious side effects.||
7016|117|I|This document does not contain all possible drug interactions.||
7016|118|I|Keep a list of all the products you use (including||
7016|119|I|prescription/nonprescription drugs and herbal products) and share||
7016|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
7016|121|I|the dosage of any medicines without your doctor's approval.||
7016|122|B|||
7016|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7016|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7016|125|O|poison control center right away. US residents can call||
7016|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
7016|127|O|medication may be harmful if swallowed.||
7016|128|B|||
7016|129|N|NOTES:  Do not share this medication with others.||
7016|130|N|   This medication has been prescribed for your current condition||
7016|131|N|only. Do not use it later for another infection unless your||
7016|132|N|doctor tells you to.||
7016|133|B|||
7016|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7016|135|D|If it is near the time of the next dose, skip the missed dose.||
7016|136|D|Use your next dose at the regular time. Do not double the dose to||
7016|137|D|catch up.||
7016|138|B|||
7016|139|R|STORAGE:  Store at room temperature. Protect from freezing. Keep||
7016|140|R|all medications away from children and pets.||
7016|141|R|   Do not flush medications down the toilet or pour them into a||
7016|142|R|drain unless instructed to do so. Properly discard this product||
7016|143|R|when it is expired or no longer needed. Consult your pharmacist||
7016|144|R|or local waste disposal company.||
7016|145|B|||
7016|146|A|Information last revised January 2025.||
7016|147|A|Copyright(c) 2025 First Databank, Inc.||
7016|148|B|||
7019|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7019|002|Z|does NOT have all possible information about this product. This||
7019|003|Z|information does not assure that this product is safe, effective,||
7019|004|Z|or appropriate for you. This information is not individual||
7019|005|Z|medical advice and does not substitute for the advice of your||
7019|006|Z|health care professional. Always ask your health care||
7019|007|Z|professional for complete information about this product and your||
7019|008|Z|specific health needs.||
7019|009|B|||
7019|010|T|DIVALPROEX SODIUM SPRINKLE CAPSULE - ORAL||
7019|011|F|(dye-VAL-proe-ex SOE-dee-um)||
7019|012|B|||
7019|013|C|COMMON BRAND NAME(S): Depakote Sprinkle||
7019|014|B|||
7019|015|W|WARNING:  Rarely, this medication has caused serious (sometimes||
7019|016|W|fatal) liver problems, usually within the first 6 months of||
7019|017|W|starting treatment. Lab tests should be performed before you||
7019|018|W|start treatment and periodically during treatment, especially||
7019|019|W|within the first 6 months, to monitor this side effect.||
7019|020|W|   The risk of serious liver problems is increased in children||
7019|021|W|younger than 2 years, especially if they have an inherited||
7019|022|W|metabolic disorder, severe seizure disorder with mental||
7019|023|W|retardation, organic brain disease, or if they take more than one||
7019|024|W|seizure medication. Talk with the doctor about the risks and||
7019|025|W|benefits of using this medication in children younger than 2||
7019|026|W|years.||
7019|027|W|   Due to an increased risk for liver problems, people with||
7019|028|W|certain inherited metabolic disorders (such as||
7019|029|W|Alpers-Huttenlocher syndrome) should not use this medication.||
7019|030|W|Children younger than 2 years who might have these disorders||
7019|031|W|should not use this medication. Children older than 2 years who||
7019|032|W|might have these disorders should be closely monitored during||
7019|033|W|treatment with divalproex sodium. Talk to your doctor for||
7019|034|W|details.||
7019|035|W|   This medication has rarely caused severe (sometimes fatal)||
7019|036|W|disease of the pancreas (pancreatitis). This may occur at any||
7019|037|W|time during treatment and can quickly worsen.||
7019|038|W|   Tell your doctor right away if you develop symptoms of liver||
7019|039|W|problems or pancreatitis such as nausea/vomiting that doesn't||
7019|040|W|stop, unusual tiredness, weakness, swelling of the face,||
7019|041|W|stomach/abdominal pain, loss of appetite, dark urine, or||
7019|042|W|yellowing eyes/skin.||
7019|043|W|   Taking this medication during pregnancy can cause birth||
7019|044|W|defects, may lower your child's IQ, and may increase the risk of||
7019|045|W|your child having certain brain/mental disorders (such as autism,||
7019|046|W|attention deficit/hyperactivity disorder). Men and women using||
7019|047|W|this medication should discuss the risks and benefits of this||
7019|048|W|medication, other treatment options, and use of reliable forms of||
7019|049|W|birth control with their doctor. If you are planning pregnancy,||
7019|050|W|or if you or your partner becomes pregnant or may be pregnant,||
7019|051|W|immediately talk to your doctor. If you are taking divalproex||
7019|052|W|sodium only to prevent migraine headaches, this medication must||
7019|053|W|not be used during pregnancy. If you are taking divalproex sodium||
7019|054|W|to treat seizures or mental/mood problems (such as bipolar||
7019|055|W|disorder), do not stop taking this medication unless directed by||
7019|056|W|your doctor. Untreated seizures and mental/mood problems (such as||
7019|057|W|bipolar disorder) are serious conditions that can harm both a||
7019|058|W|pregnant woman and her unborn baby.||
7019|059|B|||
7019|060|U|USES:  This medication is used to treat seizure disorders,||
7019|061|U|mental/mood conditions (such as manic phase of bipolar disorder),||
7019|062|U|and to prevent migraine headaches. It works by restoring the||
7019|063|U|balance of certain natural substances (neurotransmitters) in the||
7019|064|U|brain.||
7019|065|B|||
7019|066|H|HOW TO USE:  Read the Medication Guide and, if available, the||
7019|067|H|Patient Information Leaflet provided by your pharmacist before||
7019|068|H|you start taking divalproex sodium and each time you get a||
7019|069|H|refill. If you have any questions, ask your doctor or pharmacist.||
7019|070|H|   Take this medication by mouth as directed by your doctor. You||
7019|071|H|may take it with food if stomach upset occurs. This medication||
7019|072|H|may be swallowed whole or the capsule can be opened and the||
7019|073|H|entire contents sprinkled onto a small amount (teaspoonful) of||
7019|074|H|soft food, such as applesauce or pudding. Drinking water right||
7019|075|H|after taking the sprinkle and food mixture will help make sure||
7019|076|H|all sprinkles are swallowed. If you spill any of the contents,||
7019|077|H|discard it and start over with a new capsule and another portion||
7019|078|H|of food. All of the drug/food mixture should be swallowed right||
7019|079|H|away (do not chew). Do not save for future use.||
7019|080|H|   The dosage is based on your age, weight, medical condition,||
7019|081|H|response to treatment, and other medications you may be taking.||
7019|082|H|Be sure to tell your doctor and pharmacist about all the products||
7019|083|H|you use (including prescription drugs, nonprescription drugs, and||
7019|084|H|herbal products). Use this medication regularly in order to get||
7019|085|H|the most benefit from it. Remember to use it at the same time||
7019|086|H|each day to keep the amount of medication in your blood constant.||
7019|087|H|   If this medication is used for seizures, do not stop taking it||
7019|088|H|without consulting your doctor. Your condition may become worse||
7019|089|H|if the drug is suddenly stopped. Your dose may need to be||
7019|090|H|gradually decreased.||
7019|091|H|   Divalproex sodium does not relieve acute migraine headaches.||
7019|092|H|Take other medications as directed by your doctor for acute||
7019|093|H|attacks .||
7019|094|H|   Tell your doctor if your condition does not get better.||
7019|095|B|||
7019|096|S|SIDE EFFECTS:  See also Warning section.||
7019|097|S|   Diarrhea, dizziness, drowsiness, hair loss, blurred/double||
7019|098|S|vision, change in menstrual periods, ringing in the ears,||
7019|099|S|shakiness (tremor), unsteadiness, weight changes may occur. If||
7019|100|S|any of these effects last or get worse, tell your doctor or||
7019|101|S|pharmacist promptly.||
7019|102|S|   If you notice coated particles in your stool, they are||
7019|103|S|harmless. These specially coated particles do not completely||
7019|104|S|dissolve and may be passed in the stool.||
7019|105|S|   Remember that this medication has been prescribed because your||
7019|106|S|doctor has judged that the benefit to you is greater than the||
7019|107|S|risk of side effects. Many people using this medication do not||
7019|108|S|have serious side effects.||
7019|109|S|   A small number of people who take anticonvulsants for any||
7019|110|S|condition (such as seizure, bipolar disorder, pain) may||
7019|111|S|experience depression, suicidal thoughts/attempts, or other||
7019|112|S|mental/mood problems. Tell your doctor right away if you or your||
7019|113|S|family/caregiver notice any unusual/sudden changes in your mood,||
7019|114|S|thoughts, or behavior including signs of depression, suicidal||
7019|115|S|thoughts/attempts, thoughts about harming yourself.||
7019|116|S|   Severe (sometimes fatal) brain disorder (encephalopathy) has||
7019|117|S|rarely occurred, particularly in patients with certain metabolic||
7019|118|S|disorders (urea cycle disorders). Tell your doctor right away if||
7019|119|S|you develop unexplained weakness, vomiting, or sudden mental/mood||
7019|120|S|changes (such as confusion).||
7019|121|S|   Get medical help right away if you have any very serious side||
7019|122|S|effects, including: chest pain, easy bruising/unexplained||
7019|123|S|bleeding, fast/slow/irregular heartbeat, swelling of hands/feet,||
7019|124|S|uncontrolled eye movement (nystagmus), feeling cold/shivering,||
7019|125|S|rapid breathing, loss of consciousness.||
7019|126|S|   A very serious allergic reaction to this drug is rare.||
7019|127|S|However, get medical help right away if you notice any symptoms||
7019|128|S|of a serious allergic reaction, including: fever, swollen lymph||
7019|129|S|nodes, rash, itching/swelling (especially of the||
7019|130|S|face/tongue/throat), severe dizziness, trouble breathing.||
7019|131|S|   This is not a complete list of possible side effects. If you||
7019|132|S|notice other effects not listed above, contact your doctor or||
7019|133|S|pharmacist.||
7019|134|S|   In the US -||
7019|135|S|   Call your doctor for medical advice about side effects. You||
7019|136|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7019|137|S|www.fda.gov/medwatch.||
7019|138|S|   In Canada - Call your doctor for medical advice about side||
7019|139|S|effects. You may report side effects to Health Canada at||
7019|140|S|1-866-234-2345.||
7019|141|B|||
7019|142|P|PRECAUTIONS:  See also Warning section.||
7019|143|P|   Before taking divalproex sodium, tell your doctor or||
7019|144|P|pharmacist if you are allergic to it; or to valproic acid or||
7019|145|P|valproate sodium; or if you have any other allergies. This||
7019|146|P|product may contain inactive ingredients, which can cause||
7019|147|P|allergic reactions or other problems. Talk to your pharmacist for||
7019|148|P|more details.||
7019|149|P|   Before using this medication, tell your doctor or pharmacist||
7019|150|P|your medical history, especially of: liver disease, pancreatitis,||
7019|151|P|certain metabolic disorders (such as urea cycle disorders,||
7019|152|P|Alpers-Huttenlocher syndrome), alcohol abuse, bleeding problems,||
7019|153|P|brain disease (dementia), kidney disease, dehydration, poor||
7019|154|P|nutrition.||
7019|155|P|   To lower the chance of getting cut, bruised, or injured, use||
7019|156|P|caution with sharp objects like razors and nail cutters, and||
7019|157|P|avoid activities such as contact sports.||
7019|158|P|   Before having surgery, tell your doctor or dentist about all||
7019|159|P|the products you use (including prescription drugs,||
7019|160|P|nonprescription drugs, and herbal products).||
7019|161|P|   This drug may make you dizzy or drowsy or blur your vision.||
7019|162|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7019|163|P|drowsy. Do not drive, use machinery, or do anything that needs||
7019|164|P|alertness or clear vision until you can do it safely. Avoid||
7019|165|P|alcoholic beverages. Talk to your doctor if you are using||
7019|166|P|marijuana (cannabis).||
7019|167|P|   Children younger than 6 years may be at greater risk for liver||
7019|168|P|problems and pancreatitis.||
7019|169|P|   Older adults may be more sensitive to the side effects of this||
7019|170|P|drug, especially drowsiness, dizziness, unsteadiness, or tremor.||
7019|171|P|Drowsiness, dizziness, unsteadiness can increase the risk of||
7019|172|P|falling.||
7019|173|P|   Tell your doctor if you are pregnant or plan to become||
7019|174|P|pregnant. You should not become pregnant while using divalproex||
7019|175|P|sodium. Divalproex sodium may harm an unborn baby. If you become||
7019|176|P|pregnant, talk to your doctor right away about the risks and||
7019|177|P|benefits of this medication. See also Warning section.||
7019|178|P|   This medication passes into breast milk. Consult your doctor||
7019|179|P|before breastfeeding.||
7019|180|B|||
7019|181|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7019|182|I|medications work or increase your risk for serious side effects.||
7019|183|I|This document does not contain all possible drug interactions.||
7019|184|I|Keep a list of all the products you use (including||
7019|185|I|prescription/nonprescription drugs and herbal products) and share||
7019|186|I|it with your doctor and pharmacist. Do not start, stop, or change||
7019|187|I|the dosage of any medicines without your doctor's approval.||
7019|188|I|   Some products that may interact with this drug include:||
7019|189|I|certain antidepressants (such as amitriptyline, nortriptyline,||
7019|190|I|phenelzine), certain antibiotics (carbapenems such as imipenem),||
7019|191|I|mefloquine, orlistat, other medications for seizure (such as||
7019|192|I|ethosuximide, lamotrigine, rufinamide, topiramate), vorinostat,||
7019|193|I|warfarin, zidovudine.||
7019|194|I|   Tell your doctor or pharmacist if you are taking other||
7019|195|I|products that cause drowsiness including alcohol, marijuana||
7019|196|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
7019|197|I|drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle||
7019|198|I|relaxants (such as carisoprodol, cyclobenzaprine), and opioid||
7019|199|I|pain relievers (such as codeine, hydrocodone).||
7019|200|I|   Check the labels on all your medicines (such as allergy or||
7019|201|I|cough-and-cold products) because they may contain ingredients||
7019|202|I|that cause drowsiness. Ask your pharmacist about using those||
7019|203|I|products safely.||
7019|204|I|   This drug may interfere with certain lab tests (such as urine||
7019|205|I|ketones). Make sure lab personnel and your doctors know you use||
7019|206|I|this medication.||
7019|207|B|||
7019|208|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7019|209|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7019|210|O|poison control center right away. US residents can call||
7019|211|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7019|212|O|Symptoms of overdose may include: excessive drowsiness, coma,||
7019|213|O|irregular/slow heartbeat.||
7019|214|B|||
7019|215|N|NOTES:  Do not share this medication with others.||
7019|216|N|   Lab and/or medical tests (such as drug levels, liver function,||
7019|217|N|complete blood counts, clotting tests) should be done before you||
7019|218|N|start taking this medication and while you are taking it. Keep||
7019|219|N|all medical and lab appointments. Consult your doctor for more||
7019|220|N|details.||
7019|221|B|||
7019|222|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7019|223|D|remember. If it is near the time of the next dose, skip the||
7019|224|D|missed dose. Take your next dose at the regular time. Do not||
7019|225|D|double the dose to catch up.||
7019|226|B|||
7019|227|R|STORAGE:  Store at room temperature away from light and moisture.||
7019|228|R|Do not store in the bathroom. Keep all medications away from||
7019|229|R|children and pets.||
7019|230|R|   Do not flush medications down the toilet or pour them into a||
7019|231|R|drain unless instructed to do so. Properly discard this product||
7019|232|R|when it is expired or no longer needed. Consult your pharmacist||
7019|233|R|or local waste disposal company.||
7019|234|B|||
7019|235|M|MEDICAL ALERT:  Your condition can cause complications in a||
7019|236|M|medical emergency. For information about enrolling in MedicAlert,||
7019|237|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7019|238|B|||
7019|239|A|Information last revised January 2025.||
7019|240|A|Copyright(c) 2025 First Databank, Inc.||
7019|241|B|||
7022|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7022|002|Z|does NOT have all possible information about this product. This||
7022|003|Z|information does not assure that this product is safe, effective,||
7022|004|Z|or appropriate for you. This information is not individual||
7022|005|Z|medical advice and does not substitute for the advice of your||
7022|006|Z|health care professional. Always ask your health care||
7022|007|Z|professional for complete information about this product and your||
7022|008|Z|specific health needs.||
7022|009|B|||
7022|010|T|ENOXAPARIN - INJECTION||
7022|011|F|(ee-NOX-a-PAR-in)||
7022|012|B|||
7022|013|C|COMMON BRAND NAME(S): Lovenox||
7022|014|B|||
7022|015|W|WARNING:  People using this medication may bleed near the spinal||
7022|016|W|cord after certain spinal procedures. Bleeding in this area can||
7022|017|W|cause paralysis that lasts a long time or could become permanent.||
7022|018|W|Talk with your doctor about the benefits and risks before any||
7022|019|W|spinal procedure. Your doctor may direct you to stop this||
7022|020|W|medication for a certain amount of time before and after the||
7022|021|W|procedure. Carefully follow your doctor's directions.||
7022|022|W|   The risk of bleeding may be higher if you have a deformed||
7022|023|W|spine, or have had spinal procedures/surgery before (such as||
7022|024|W|epidural catheter placement, difficult epidural/spinal puncture),||
7022|025|W|or are taking other drugs that can cause bleeding/bruising||
7022|026|W|(including antiplatelet drugs such as clopidogrel, "blood||
7022|027|W|thinners" such as warfarin/rivaroxaban, nonsteroidal||
7022|028|W|anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your||
7022|029|W|doctor right away if you notice symptoms such as back pain, leg||
7022|030|W|numbness/tingling/weakness, loss of control of the bowels or||
7022|031|W|bladder (incontinence).||
7022|032|B|||
7022|033|U|USES:  Enoxaparin is used to prevent and treat harmful blood||
7022|034|U|clots. This helps to reduce the risk of a stroke or heart attack.||
7022|035|U|This medication helps keep your blood flowing smoothly by||
7022|036|U|lowering the activity of clotting proteins in the blood.||
7022|037|U|Enoxaparin is an anticoagulant, also known as a "blood thinner."||
7022|038|U|It is a type of heparin.||
7022|039|U|   Conditions which increase your risk of developing blood clots||
7022|040|U|include certain types of surgeries (such as knee/hip replacement,||
7022|041|U|abdominal), long periods of being immobile, certain types of||
7022|042|U|heart attack, and a specific type of chest pain called unstable||
7022|043|U|angina. For some medical conditions, enoxaparin may be used in||
7022|044|U|combination with other "blood thinners."||
7022|045|B|||
7022|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7022|047|H|from your pharmacist before you start using enoxaparin and each||
7022|048|H|time you get a refill. Ask your health care professional how to||
7022|049|H|prepare and use this medication. If you have any questions, ask||
7022|050|H|your doctor or pharmacist.||
7022|051|H|   Inject this medication under the skin as directed by your||
7022|052|H|doctor, usually once or twice a day. The injection is given in||
7022|053|H|the abdomen (at least 2 inches from your belly button). Do not||
7022|054|H|inject into a muscle. The dosage and length of treatment are||
7022|055|H|based on your medical condition, age, weight, and response to||
7022|056|H|treatment.||
7022|057|H|    Before using, check this product for particles or||
7022|058|H|discoloration. If either is present, do not use the liquid.||
7022|059|H|Before injecting each dose, clean the skin you are going to||
7022|060|H|inject into (the injection site) with rubbing alcohol. Change the||
7022|061|H|injection site each time to lessen injury under the skin. To||
7022|062|H|lessen bruising, do not rub the injection site after a shot.||
7022|063|H|Learn how to store and discard medical supplies safely.||
7022|064|H|   This medication may also be given by injection into a vein by||
7022|065|H|a health care professional, as directed by your doctor.||
7022|066|H|   Use this medication regularly to get the most benefit from it.||
7022|067|H|To help you remember, use it at the same time(s) each day.||
7022|068|B|||
7022|069|S|SIDE EFFECTS:  See also Warning section.||
7022|070|S|   Mild irritation, pain, bruising, redness, and swelling at the||
7022|071|S|injection site may occur. Tiredness or fever may also occur. If||
7022|072|S|any of these effects last or get worse, tell your doctor or||
7022|073|S|pharmacist promptly.||
7022|074|S|   Remember that this medication has been prescribed because your||
7022|075|S|doctor has judged that the benefit to you is greater than the||
7022|076|S|risk of side effects. Many people using this medication do not||
7022|077|S|have serious side effects.||
7022|078|S|   This medication can cause bleeding if its effect on your blood||
7022|079|S|clotting proteins is too much. Tell your doctor right away if you||
7022|080|S|have any serious signs of bleeding, including: unusual||
7022|081|S|pain/swelling/discomfort, unusual or prolonged bleeding, unusual||
7022|082|S|or easy bruising, dark urine, black stools, severe headache,||
7022|083|S|confusion, vision changes, unusual dizziness, fainting, seizures,||
7022|084|S|weakness, numbness.||
7022|085|S|   A very serious allergic reaction to this drug is rare.||
7022|086|S|However, get medical help right away if you notice any symptoms||
7022|087|S|of a serious allergic reaction, including: rash, itching/swelling||
7022|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7022|089|S|breathing.||
7022|090|S|   This is not a complete list of possible side effects. If you||
7022|091|S|notice other effects not listed above, contact your doctor or||
7022|092|S|pharmacist.||
7022|093|S|   In the US -||
7022|094|S|   Call your doctor for medical advice about side effects. You||
7022|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7022|096|S|www.fda.gov/medwatch.||
7022|097|S|   In Canada - Call your doctor for medical advice about side||
7022|098|S|effects. You may report side effects to Health Canada at||
7022|099|S|1-866-234-2345.||
7022|100|B|||
7022|101|P|PRECAUTIONS:  Before using enoxaparin, tell your doctor or||
7022|102|P|pharmacist if you are allergic to it; or to heparin or pork||
7022|103|P|products; or if you have any other allergies. This product may||
7022|104|P|contain inactive ingredients, which can cause allergic reactions||
7022|105|P|or other problems. Talk to your pharmacist for more details.||
7022|106|P|   Before using enoxaparin, tell your doctor or pharmacist your||
7022|107|P|medical history, especially of: artificial heart valve(s), kidney||
7022|108|P|disease, liver disease, bleeding/blood problems (such as low||
7022|109|P|platelet counts), low platelet counts after previous heparin||
7022|110|P|treatment, stroke, high blood pressure, certain eye problems||
7022|111|P|(such as diabetic retinopathy), certain stomach/intestinal||
7022|112|P|problems (such as active or recent ulcers), recent spinal||
7022|113|P|procedure or puncture, spine problems (such as spinal deformity),||
7022|114|P|recent eye/brain/spinal cord surgery.||
7022|115|P|   Limit alcohol while taking this drug because it may increase||
7022|116|P|the risk of stomach bleeding.||
7022|117|P|   Before having surgery, tell your doctor or dentist about all||
7022|118|P|the products you use (including prescription drugs,||
7022|119|P|nonprescription drugs, and herbal products).||
7022|120|P|   To lower the chance of getting cut, bruised, or injured, use||
7022|121|P|caution with sharp objects like razors and nail cutters, and||
7022|122|P|avoid activities such as contact sports.||
7022|123|P|   Older adults may be more sensitive to the side effects of this||
7022|124|P|drug, especially bleeding.||
7022|125|P|   During pregnancy, this medication should be used only when||
7022|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
7022|127|P|   It is unknown if this drug passes into breast milk. Consult||
7022|128|P|your doctor before breastfeeding.||
7022|129|B|||
7022|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7022|131|I|medications work or increase your risk for serious side effects.||
7022|132|I|This document does not contain all possible drug interactions.||
7022|133|I|Keep a list of all the products you use (including||
7022|134|I|prescription/nonprescription drugs and herbal products) and share||
7022|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
7022|136|I|the dosage of any medicines without your doctor's approval.||
7022|137|I|   A product that may interact with this drug is: mifepristone.||
7022|138|I|   This medication is sometimes used together with other drugs||
7022|139|I|that have "blood thinning" or anti-platelet effects such as||
7022|140|I|aspirin, clopidogrel, or warfarin. When these combinations are||
7022|141|I|prescribed by your doctor, you will require closer monitoring to||
7022|142|I|minimize your risk of bleeding. Keep all medical and lab||
7022|143|I|appointments.||
7022|144|I|   Check all prescription and nonprescription medicine labels||
7022|145|I|carefully since many medications contain pain relievers/fever||
7022|146|I|reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) which||
7022|147|I|can increase the risk of bleeding/anti-platelet effect when used||
7022|148|I|with enoxaparin. However, if your doctor has told you to take||
7022|149|I|low-dose aspirin to prevent heart attack or stroke (usually||
7022|150|I|81-162 milligrams a day), you should keep taking the aspirin||
7022|151|I|unless your doctor tells you not to. Ask your doctor or||
7022|152|I|pharmacist for more details.||
7022|153|B|||
7022|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7022|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7022|156|O|poison control center right away. US residents can call||
7022|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7022|158|O|Symptoms of overdose may include: excessive bleeding and||
7022|159|O|bruising.||
7022|160|B|||
7022|161|N|NOTES:  Do not share this medication with others.||
7022|162|N|   Lab and/or medical tests (such as complete blood count,||
7022|163|N|anti-factor Xa blood levels) should be done while you are using||
7022|164|N|this medication. Keep all medical and lab appointments. Consult||
7022|165|N|your doctor for more details.||
7022|166|B|||
7022|167|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7022|168|D|If it is near the time of the next dose, skip the missed dose.||
7022|169|D|Use your next dose at the regular time. Do not double the dose to||
7022|170|D|catch up.||
7022|171|B|||
7022|172|R|STORAGE:  Store at room temperature away from light. Discard the||
7022|173|R|multiple dose vials 28 days after the first use. Keep all||
7022|174|R|medications away from children and pets.||
7022|175|R|   Do not flush medications down the toilet or pour them into a||
7022|176|R|drain unless instructed to do so. Properly discard this product||
7022|177|R|when it is expired or no longer needed. Consult your pharmacist||
7022|178|R|or local waste disposal company.||
7022|179|B|||
7022|180|M|MEDICAL ALERT:  Your condition can cause complications in a||
7022|181|M|medical emergency. For information about enrolling in MedicAlert,||
7022|182|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7022|183|B|||
7022|184|A|Information last revised August 2024.||
7022|185|A|Copyright(c) 2025 First Databank, Inc.||
7022|186|B|||
7026|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7026|002|Z|does NOT have all possible information about this product. This||
7026|003|Z|information does not assure that this product is safe, effective,||
7026|004|Z|or appropriate for you. This information is not individual||
7026|005|Z|medical advice and does not substitute for the advice of your||
7026|006|Z|health care professional. Always ask your health care||
7026|007|Z|professional for complete information about this product and your||
7026|008|Z|specific health needs.||
7026|009|B|||
7026|010|T|ERGOLOID MESYLATES - ORAL||
7026|011|F|(ER-goe-loyd MES-i-lates)||
7026|012|B|||
7026|013|C|COMMON BRAND NAME(S): Hydergine||
7026|014|B|||
7026|015|U|USES:  This medication is used to treat mild problems with mood,||
7026|016|U|memory, concentration, or behavior in older adults. It is||
7026|017|U|believed to increase blood flow to the brain. It is a combination||
7026|018|U|of 3 ergot alkaloids.||
7026|019|B|||
7026|020|H|HOW TO USE:  Take this medication by mouth as directed by your||
7026|021|H|doctor, usually 3 times daily.||
7026|022|H|   Use this medication regularly to get the most benefit from it.||
7026|023|H|To help you remember, take it at the same times each day.||
7026|024|H|   It may take several weeks before you see any improvement from||
7026|025|H|the medication. Tell your doctor if your condition lasts or gets||
7026|026|H|worse.||
7026|027|B|||
7026|028|S|SIDE EFFECTS:  Nausea, vomiting, blurred vision, dizziness,||
7026|029|S|drowsiness, flushing, loss of appetite, or stomach upset may||
7026|030|S|occur. If any of these effects last or get worse, tell your||
7026|031|S|doctor or pharmacist promptly.||
7026|032|S|   Remember that this medication has been prescribed because your||
7026|033|S|doctor has judged that the benefit to you is greater than the||
7026|034|S|risk of side effects. Many people using this medication do not||
7026|035|S|have serious side effects.||
7026|036|S|   Tell your doctor right away if you have any serious side||
7026|037|S|effects, including: fainting, slow heartbeat.||
7026|038|S|   A very serious allergic reaction to this drug is rare.||
7026|039|S|However, get medical help right away if you notice any symptoms||
7026|040|S|of a serious allergic reaction, including: rash, itching/swelling||
7026|041|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7026|042|S|breathing.||
7026|043|S|   This is not a complete list of possible side effects. If you||
7026|044|S|notice other effects not listed above, contact your doctor or||
7026|045|S|pharmacist.||
7026|046|S|   In the US -||
7026|047|S|   Call your doctor for medical advice about side effects. You||
7026|048|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7026|049|S|www.fda.gov/medwatch.||
7026|050|S|   In Canada - Call your doctor for medical advice about side||
7026|051|S|effects. You may report side effects to Health Canada at||
7026|052|S|1-866-234-2345.||
7026|053|B|||
7026|054|P|PRECAUTIONS:  Before taking ergoloid mesylates, tell your doctor||
7026|055|P|or pharmacist if you are allergic to them; or to other ergot||
7026|056|P|alkaloids (such as dihydroergotamine, ergotamine); or if you have||
7026|057|P|any other allergies. This product may contain inactive||
7026|058|P|ingredients, which can cause allergic reactions or other||
7026|059|P|problems. Talk to your pharmacist for more details.||
7026|060|P|   Before using this medication, tell your doctor or pharmacist||
7026|061|P|your medical history, especially of: mental/mood disorders (such||
7026|062|P|as psychosis), blood pressure problems, heart problems, liver||
7026|063|P|disease.||
7026|064|P|   This drug may make you dizzy or drowsy or blur your vision.||
7026|065|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7026|066|P|drowsy. Do not drive, use machinery, or do anything that needs||
7026|067|P|alertness or clear vision until you can do it safely. Limit||
7026|068|P|alcoholic beverages. Talk to your doctor if you are using||
7026|069|P|marijuana (cannabis).||
7026|070|P|   Before having surgery, tell your doctor or dentist about all||
7026|071|P|the products you use (including prescription drugs,||
7026|072|P|nonprescription drugs, and herbal products).||
7026|073|P|   During pregnancy, this medication should be used only when||
7026|074|P|clearly needed. Discuss the risks and benefits with your doctor.||
7026|075|P|   It is unknown if this drug passes into breast milk. Consult||
7026|076|P|your doctor before breastfeeding.||
7026|077|B|||
7026|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7026|079|I|medications work or increase your risk for serious side effects.||
7026|080|I|This document does not contain all possible drug interactions.||
7026|081|I|Keep a list of all the products you use (including||
7026|082|I|prescription/nonprescription drugs and herbal products) and share||
7026|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
7026|084|I|the dosage of any medicines without your doctor's approval.||
7026|085|I|   Other medications can affect the removal of ergoloid mesylates||
7026|086|I|from your body, which may affect how ergoloid mesylates works.||
7026|087|I|Examples include azole antifungals (such as itraconazole,||
7026|088|I|ketoconazole, voriconazole), cobicistat, macrolide antibiotics||
7026|089|I|(such as clarithromycin, erythromycin, troleandomycin),||
7026|090|I|nefazodone, HIV protease inhibitors (such as nelfinavir),||
7026|091|I|ritonavir, telithromycin, among others.||
7026|092|I|   If you also take "triptan" migraine drugs (such as||
7026|093|I|sumatriptan, rizatriptan), you will need to separate your||
7026|094|I|"triptan" dose from your dose of this medication to reduce the||
7026|095|I|risk of serious side effects. Ask your doctor how long you should||
7026|096|I|wait between your doses of these drugs.||
7026|097|I|   Some products have ingredients that could raise your heart||
7026|098|I|rate or blood pressure. Tell your pharmacist what products you||
7026|099|I|are using, and ask how to use them safely (especially||
7026|100|I|cough-and-cold products, diet aids, or other migraine||
7026|101|I|medications).||
7026|102|B|||
7026|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7026|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7026|105|O|poison control center right away. US residents can call||
7026|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7026|107|B|||
7026|108|N|NOTES:  Do not share this medication with others.||
7026|109|N|   Keep all medical appointments.||
7026|110|B|||
7026|111|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7026|112|D|remember. If it is near the time of the next dose, skip the||
7026|113|D|missed dose. Take your next dose at the regular time. Do not||
7026|114|D|double the dose to catch up.||
7026|115|B|||
7026|116|R|STORAGE:  Store at room temperature away from light and moisture.||
7026|117|R|Do not store in the bathroom. Keep all medications away from||
7026|118|R|children and pets.||
7026|119|R|   Do not flush medications down the toilet or pour them into a||
7026|120|R|drain unless instructed to do so. Properly discard this product||
7026|121|R|when it is expired or no longer needed. Consult your pharmacist||
7026|122|R|or local waste disposal company.||
7026|123|B|||
7026|124|A|Information last revised April 2025.||
7026|125|A|Copyright(c) 2025 First Databank, Inc.||
7026|126|B|||
7027|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7027|002|Z|does NOT have all possible information about this product. This||
7027|003|Z|information does not assure that this product is safe, effective,||
7027|004|Z|or appropriate for you. This information is not individual||
7027|005|Z|medical advice and does not substitute for the advice of your||
7027|006|Z|health care professional. Always ask your health care||
7027|007|Z|professional for complete information about this product and your||
7027|008|Z|specific health needs.||
7027|009|B|||
7027|010|T|ESTROGENS CREAM - VAGINAL||
7027|011|F|(ES-troe-jenz)||
7027|012|B|||
7027|013|W|WARNING:  Estrogens, either used alone or with another hormone||
7027|014|W|(progestin), have rarely caused very serious side effects.||
7027|015|W|Discuss the risks and benefits of hormone treatment with your||
7027|016|W|doctor. Estrogens should not be used to prevent heart disease or||
7027|017|W|dementia.||
7027|018|W|   Estrogens can increase the risk of cancer of the uterus||
7027|019|W|(endometrial cancer). Taking a progestin as directed by your||
7027|020|W|doctor can help decrease this risk. Tell your doctor right away||
7027|021|W|if you have any unusual vaginal bleeding.||
7027|022|W|   In postmenopausal women, estrogens, taken with or without a||
7027|023|W|progestin, increase the risk of cancer of the breast/ovaries,||
7027|024|W|stroke, dementia, and serious blood clots. When used along with a||
7027|025|W|progestin, estrogens also increase the risk of heart disease||
7027|026|W|(such as heart attacks).||
7027|027|W|   The risk for serious side effects may depend on the dose of||
7027|028|W|estrogen and the length of time it is used. This medication||
7027|029|W|should be used at the lowest effective dose and for the shortest||
7027|030|W|amount of time. Discuss the use of this medication with your||
7027|031|W|doctor and check with him/her regularly (for example, every 3 to||
7027|032|W|6 months) to see if you still need to use this medication. If you||
7027|033|W|will be using this medication long-term, you should have regular||
7027|034|W|complete physical exams (for example, once a year) as directed by||
7027|035|W|your doctor. See also Notes section.||
7027|036|B|||
7027|037|U|USES:  This medication is a hormone. It is used by women to help||
7027|038|U|reduce vaginal symptoms of menopause (such as vaginal||
7027|039|U|dryness/burning/itching). These symptoms are caused by the body||
7027|040|U|making less estrogen. When treating only vaginal symptoms of||
7027|041|U|menopause, products applied directly inside the vagina (such as||
7027|042|U|this medication) should be used first. Estrogens that are taken||
7027|043|U|by mouth, absorbed through the skin, or injected may have greater||
7027|044|U|risks of side effects due to more estrogen being absorbed.||
7027|045|B|||
7027|046|V|OTHER USES:  This section contains uses of this drug that are not||
7027|047|V|listed in the approved professional labeling for the drug but||
7027|048|V|that may be prescribed by your health care professional. Use this||
7027|049|V|drug for a condition that is listed in this section only if it||
7027|050|V|has been so prescribed by your health care professional.||
7027|051|V|   This medication may also be used for a certain condition in||
7027|052|V|which the labia stick together (labial adhesion).||
7027|053|B|||
7027|054|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7027|055|H|from your pharmacist before you start using this medication and||
7027|056|H|each time you get a refill. If you have any questions, ask your||
7027|057|H|doctor or pharmacist.||
7027|058|H|   Use this medication as directed by your doctor. Fill the||
7027|059|H|applicator with the medication according to the directions.||
7027|060|H|Insert the applicator high into the vagina and press the plunger||
7027|061|H|to release the medication. Clean the applicator with warm soapy||
7027|062|H|water and rinse well. Do not boil or use hot water to clean the||
7027|063|H|applicator.||
7027|064|H|   The dosage is based on your medical condition and response to||
7027|065|H|treatment.||
7027|066|H|   Use this medication regularly to get the most benefit from it.||
7027|067|H|Follow your dosing schedule carefully. Do not increase your dose||
7027|068|H|or use this medication more often or for a longer time than||
7027|069|H|directed.||
7027|070|H|   Tell your doctor if your condition does not get better or if||
7027|071|H|it gets worse.||
7027|072|B|||
7027|073|S|SIDE EFFECTS:  See also Warning section.||
7027|074|S|   Nausea/vomiting, bloating, breast tenderness, headache, or||
7027|075|S|weight changes may occur. If any of these effects last or get||
7027|076|S|worse, tell your doctor or pharmacist promptly.||
7027|077|S|   Remember that this medication has been prescribed because your||
7027|078|S|doctor has judged that the benefit to you is greater than the||
7027|079|S|risk of side effects. Many people using this medication do not||
7027|080|S|have serious side effects.||
7027|081|S|   Tell your doctor right away if you have any serious side||
7027|082|S|effects, including: nausea/vomiting that doesn't stop,||
7027|083|S|mental/mood changes (such as depression, memory loss), breast||
7027|084|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
7027|085|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
7027|086|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
7027|087|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
7027|088|S|increased thirst/urination.||
7027|089|S|   This medication may rarely cause serious (sometimes fatal)||
7027|090|S|problems from blood clots (such as heart attack, stroke, blood||
7027|091|S|clots in the lungs or legs). Get medical help right away if you||
7027|092|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
7027|093|S|headaches, weakness on one side of the body, confusion, trouble||
7027|094|S|speaking, sudden vision changes, pain/swelling/warmth in the||
7027|095|S|groin/calf, shortness of breath/rapid breathing, sudden||
7027|096|S|dizziness/fainting.||
7027|097|S|   A very serious allergic reaction to this product is rare.||
7027|098|S|However, get medical help right away if you notice any symptoms||
7027|099|S|of a serious allergic reaction, including: rash, itching/swelling||
7027|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7027|101|S|breathing.||
7027|102|S|   This is not a complete list of possible side effects. If you||
7027|103|S|notice other effects not listed above, contact your doctor or||
7027|104|S|pharmacist.||
7027|105|S|   In the US -||
7027|106|S|   Call your doctor for medical advice about side effects. You||
7027|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7027|108|S|www.fda.gov/medwatch.||
7027|109|S|   In Canada - Call your doctor for medical advice about side||
7027|110|S|effects. You may report side effects to Health Canada at||
7027|111|S|1-866-234-2345.||
7027|112|B|||
7027|113|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
7027|114|P|pharmacist if you are allergic to it; or if you have any other||
7027|115|P|allergies. This product may contain inactive ingredients, which||
7027|116|P|can cause allergic reactions or other problems. Talk to your||
7027|117|P|pharmacist for more details.||
7027|118|P|   Before using this medication, tell your doctor or pharmacist||
7027|119|P|your medical history, especially of: vaginal bleeding of unknown||
7027|120|P|cause, certain cancers (such as breast cancer, cancer of the||
7027|121|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
7027|122|P|heart attack), liver disease, kidney disease, family medical||
7027|123|P|history (especially breast lumps, cancer, blood clots), family or||
7027|124|P|personal history of a certain swelling disorder (angioedema),||
7027|125|P|blood clotting disorders (such as protein C or protein S||
7027|126|P|deficiency), high blood pressure, diabetes, high||
7027|127|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
7027|128|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
7027|129|P|calcium in the blood), a certain hormone problem||
7027|130|P|(hypoparathyroidism), uterus problems (such as fibroids,||
7027|131|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
7027|132|P|headaches, mental/mood disorders (such as dementia, depression),||
7027|133|P|certain blood disorder (porphyria).||
7027|134|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
7027|135|P|further increases your risk of stroke, blood clots, high blood||
7027|136|P|pressure, and heart attack, especially in women older than 35.||
7027|137|P|   Tell your doctor if you just had or will be having surgery, or||
7027|138|P|if you will be confined to a chair or bed for a long time (such||
7027|139|P|as a long plane flight). These conditions increase your risk of||
7027|140|P|getting blood clots, especially if you are using an estrogen||
7027|141|P|product. You may need to stop this medication for a time or take||
7027|142|P|special precautions.||
7027|143|P|   This medication may cause blotchy, dark areas on your face and||
7027|144|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
7027|145|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
7027|146|P|wear protective clothing when outdoors.||
7027|147|P|   If you are nearsighted or wear contact lenses, you may develop||
7027|148|P|vision problems or trouble wearing your contact lenses. Contact||
7027|149|P|your eye doctor if these problems occur.||
7027|150|P|   Some estrogen products contain mineral oil which can weaken||
7027|151|P|rubber products such as latex condoms, cervical caps, and||
7027|152|P|diaphragms and lead to their failure. Consult your pharmacist if||
7027|153|P|you are unsure if your product contains mineral oil. If it does,||
7027|154|P|talk to your doctor about other birth control products (such as||
7027|155|P|polyurethane condoms) while you are using this medication.||
7027|156|P|   This medication should not be used during pregnancy. If you||
7027|157|P|become pregnant or think you may be pregnant, tell your doctor||
7027|158|P|right away.||
7027|159|P|   This medication passes into breast milk. Consult your doctor||
7027|160|P|before breastfeeding.||
7027|161|B|||
7027|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7027|163|I|medications work or increase your risk for serious side effects.||
7027|164|I|This document does not contain all possible drug interactions.||
7027|165|I|Keep a list of all the products you use (including||
7027|166|I|prescription/nonprescription drugs and herbal products) and share||
7027|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
7027|168|I|the dosage of any medicines without your doctor's approval.||
7027|169|I|   Some products that may interact with this drug include:||
7027|170|I|aromatase inhibitors (such as anastrozole, exemestane,||
7027|171|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
7027|172|I|tamoxifen, toremifene, tranexamic acid.||
7027|173|I|   This medication may interfere with certain lab tests (such as||
7027|174|I|metyrapone test), possibly causing false test results. Make sure||
7027|175|I|lab personnel and all your doctors know you use this drug.||
7027|176|B|||
7027|177|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7027|178|O|has overdosed and has serious symptoms such as passing out or||
7027|179|O|trouble breathing, call 911. Otherwise, call a poison control||
7027|180|O|center right away. US residents can call 1-800-222-1222. Canada||
7027|181|O|residents can call 1-844-764-7669. Symptoms of overdose may||
7027|182|O|include: severe nausea/vomiting, unusual vaginal bleeding.||
7027|183|B|||
7027|184|N|NOTES:  Do not share this medication with others.||
7027|185|N|   Regular complete physical exams which include lab and/or||
7027|186|N|medical tests (such as blood pressure, breast exam/mammogram,||
7027|187|N|pelvic exam, Pap smear) should be done while you are using this||
7027|188|N|medication. Follow your doctor's instructions for examining your||
7027|189|N|breasts, and report any lumps right away. Keep all medical and||
7027|190|N|lab appointments. Consult your doctor for more details.||
7027|191|N|   Preventing or controlling high blood pressure, high||
7027|192|N|cholesterol, and diabetes can help to reduce your chances of||
7027|193|N|heart disease and stroke. Lifestyle changes that can help to||
7027|194|N|control or prevent these diseases include reducing stress, eating||
7027|195|N|a low fat/salt diet, losing weight if overweight, exercising||
7027|196|N|regularly, and stopping smoking. Keep your mind active with||
7027|197|N|mental exercises (such as reading, solving crossword puzzles) to||
7027|198|N|help prevent dementia. Talk to your doctor about lifestyle||
7027|199|N|changes that might benefit you.||
7027|200|B|||
7027|201|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7027|202|D|If it is near the time of the next dose, skip the missed dose.||
7027|203|D|Use your next dose at the regular time. Do not double the dose to||
7027|204|D|catch up.||
7027|205|B|||
7027|206|R|STORAGE:  Store at room temperature. Keep all medications away||
7027|207|R|from children and pets.||
7027|208|R|   Do not flush medications down the toilet or pour them into a||
7027|209|R|drain unless instructed to do so. Properly discard this product||
7027|210|R|when it is expired or no longer needed. Consult your pharmacist||
7027|211|R|or local waste disposal company.||
7027|212|B|||
7027|213|A|Information last revised October 2024.||
7027|214|A|Copyright(c) 2025 First Databank, Inc.||
7027|215|B|||
7028|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7028|002|Z|does NOT have all possible information about this product. This||
7028|003|Z|information does not assure that this product is safe, effective,||
7028|004|Z|or appropriate for you. This information is not individual||
7028|005|Z|medical advice and does not substitute for the advice of your||
7028|006|Z|health care professional. Always ask your health care||
7028|007|Z|professional for complete information about this product and your||
7028|008|Z|specific health needs.||
7028|009|B|||
7028|010|T|ETHIONAMIDE - ORAL||
7028|011|F|(e-thye-ON-a-mide)||
7028|012|B|||
7028|013|C|COMMON BRAND NAME(S): Trecator||
7028|014|B|||
7028|015|U|USES:  Ethionamide is used with other medications to treat||
7028|016|U|tuberculosis (TB). Ethionamide is an antibiotic and works by||
7028|017|U|stopping the growth of bacteria.||
7028|018|U|   This antibiotic treats only bacterial infections. It will not||
7028|019|U|work for viral infections (such as common cold, flu). Using any||
7028|020|U|antibiotic when it is not needed can cause it to not work for||
7028|021|U|future infections.||
7028|022|B|||
7028|023|V|OTHER USES:  This section contains uses of this drug that are not||
7028|024|V|listed in the approved professional labeling for the drug but||
7028|025|V|that may be prescribed by your health care professional. Use this||
7028|026|V|drug for a condition that is listed in this section only if it||
7028|027|V|has been so prescribed by your health care professional.||
7028|028|V|   This drug may also be used for a certain serious infection||
7028|029|V|(Mycobacterium avium complex-MAC).||
7028|030|B|||
7028|031|H|HOW TO USE:  Take this medication by mouth with or without food||
7028|032|H|as directed by your doctor, usually once daily. If this||
7028|033|H|medication causes stomach upset or nausea/vomiting, take this||
7028|034|H|medication with meals. Also, discuss with your doctor if it may||
7028|035|H|be helpful to divide your daily dose into smaller doses to be||
7028|036|H|taken several times a day. Follow your doctor's instructions||
7028|037|H|carefully.||
7028|038|H|   The dosage is based on your age, weight, medical condition,||
7028|039|H|and response to treatment.||
7028|040|H|   For the best effect, take this antibiotic at evenly spaced||
7028|041|H|times. To help you remember, take this medication at the same||
7028|042|H|time(s) every day.||
7028|043|H|   Continue to take this medication (and other TB medications)||
7028|044|H|until the full prescribed amount is finished, even if symptoms||
7028|045|H|disappear. Stopping the medication too early or skipping doses||
7028|046|H|may result in a return of the infection and cause the infection||
7028|047|H|to be more difficult to treat (resistant).||
7028|048|H|   Your doctor may also direct you to take vitamin B6||
7028|049|H|(pyridoxine) to help prevent certain side effects (such as nerve||
7028|050|H|problems) from ethionamide. Follow your doctor's instructions||
7028|051|H|carefully.||
7028|052|H|   Tell your doctor if your condition lasts or gets worse.||
7028|053|B|||
7028|054|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, abdominal/stomach||
7028|055|S|pain, increased saliva, strange metallic taste in the mouth, loss||
7028|056|S|of appetite, or sores in the mouth may occur. If any of these||
7028|057|S|effects last or get worse, tell your doctor or pharmacist||
7028|058|S|promptly.||
7028|059|S|   Many people using this medication may have serious side||
7028|060|S|effects. However, you have been prescribed this drug because your||
7028|061|S|doctor has judged that the benefit to you is greater than the||
7028|062|S|risk of side effects. Careful monitoring by your doctor may||
7028|063|S|decrease your risk.||
7028|064|S|   Tell your doctor right away if you have any serious side||
7028|065|S|effects, including: nausea/vomiting that doesn't stop, unusual||
7028|066|S|hunger, unusual sweating, shakiness, unusual tiredness/weakness,||
7028|067|S|yellowing eyes/skin, dark urine, joint pain/swelling, slow||
7028|068|S|heartbeat, mental/mood changes (such as nervousness,||
7028|069|S|restlessness, depression), vision changes (such as||
7028|070|S|blurred/decreased/double vision, color blindness), eye pain,||
7028|071|S|numbness/tingling of arms/legs.||
7028|072|S|   A very serious allergic reaction to this drug is rare.||
7028|073|S|However, get medical help right away if you notice any symptoms||
7028|074|S|of a serious allergic reaction, including: fever that doesn't go||
7028|075|S|away, new or worsening lymph node swelling, rash,||
7028|076|S|itching/swelling (especially of the face/tongue/throat), severe||
7028|077|S|dizziness, trouble breathing.||
7028|078|S|   This is not a complete list of possible side effects. If you||
7028|079|S|notice other effects not listed above, contact your doctor or||
7028|080|S|pharmacist.||
7028|081|S|   In the US -||
7028|082|S|   Call your doctor for medical advice about side effects. You||
7028|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7028|084|S|www.fda.gov/medwatch.||
7028|085|S|   In Canada - Call your doctor for medical advice about side||
7028|086|S|effects. You may report side effects to Health Canada at||
7028|087|S|1-866-234-2345.||
7028|088|B|||
7028|089|P|PRECAUTIONS:  Before taking ethionamide, tell your doctor or||
7028|090|P|pharmacist if you are allergic to it; or if you have any other||
7028|091|P|allergies. This product may contain inactive ingredients, which||
7028|092|P|can cause allergic reactions or other problems. Talk to your||
7028|093|P|pharmacist for more details.||
7028|094|P|   Before using this medication, tell your doctor or pharmacist||
7028|095|P|your medical history, especially of: liver disease, kidney||
7028|096|P|disease, underactive thyroid (hypothyroidism), eye problems (such||
7028|097|P|as optic neuritis, cataracts, diabetic retinopathy).||
7028|098|P|   Alcohol may increase the risk of liver disease or mental/mood||
7028|099|P|changes. Avoid alcoholic beverages while using this medication.||
7028|100|P|   Ethionamide may cause live bacterial vaccines (such as typhoid||
7028|101|P|vaccine) to not work well. Tell your health care professional||
7028|102|P|that you are using ethionamide before having any||
7028|103|P|immunizations/vaccinations.||
7028|104|P|   Before having surgery, tell your doctor or dentist about all||
7028|105|P|the products you use (including prescription drugs,||
7028|106|P|nonprescription drugs, and herbal products).||
7028|107|P|   If you have diabetes, this product may lower your blood sugar.||
7028|108|P|Check your blood sugar regularly as directed and share the||
7028|109|P|results with your doctor. Tell your doctor right away if you have||
7028|110|P|symptoms of low blood sugar, such as sudden sweating, shaking,||
7028|111|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
7028|112|P|hands/feet. Your doctor may need to adjust your diabetes||
7028|113|P|medication, exercise program, or diet.||
7028|114|P|   Tell your doctor if you are pregnant or plan to become||
7028|115|P|pregnant. You should not become pregnant while using ethionamide.||
7028|116|P|Ethionamide may harm an unborn baby. If you become pregnant, talk||
7028|117|P|to your doctor right away about the risks and benefits of this||
7028|118|P|medication.||
7028|119|P|   It is unknown if this drug passes into breast milk. Consult||
7028|120|P|your doctor before breastfeeding.||
7028|121|B|||
7028|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7028|123|I|medications work or increase your risk for serious side effects.||
7028|124|I|This document does not contain all possible drug interactions.||
7028|125|I|Keep a list of all the products you use (including||
7028|126|I|prescription/nonprescription drugs and herbal products) and share||
7028|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
7028|128|I|the dosage of any medicines without your doctor's approval.||
7028|129|B|||
7028|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7028|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7028|132|O|poison control center right away. US residents can call||
7028|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7028|134|B|||
7028|135|N|NOTES:  Do not share this medication with others.||
7028|136|N|   Lab and/or medical tests (such as sputum test, eye/vision||
7028|137|N|exams, liver/thyroid function, blood glucose, complete blood||
7028|138|N|count) should be done while you are taking this medication. Keep||
7028|139|N|all medical and lab appointments. Consult your doctor for more||
7028|140|N|details.||
7028|141|B|||
7028|142|D|MISSED DOSE:  It is important to take each dose of this||
7028|143|D|medication as scheduled. If you miss a dose, take it as soon as||
7028|144|D|you remember. If it is near the time of the next dose, skip the||
7028|145|D|missed dose. Take your next dose at the regular time. Do not||
7028|146|D|double the dose to catch up.||
7028|147|B|||
7028|148|R|STORAGE:  Store at room temperature away from light and moisture.||
7028|149|R|Do not store in the bathroom. Keep all medications away from||
7028|150|R|children and pets.||
7028|151|R|   Do not flush medications down the toilet or pour them into a||
7028|152|R|drain unless instructed to do so. Properly discard this product||
7028|153|R|when it is expired or no longer needed. Consult your pharmacist||
7028|154|R|or local waste disposal company.||
7028|155|B|||
7028|156|A|Information last revised May 2024.||
7028|157|A|Copyright(c) 2025 First Databank, Inc.||
7028|158|B|||
7030|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7030|002|Z|does NOT have all possible information about this product. This||
7030|003|Z|information does not assure that this product is safe, effective,||
7030|004|Z|or appropriate for you. This information is not individual||
7030|005|Z|medical advice and does not substitute for the advice of your||
7030|006|Z|health care professional. Always ask your health care||
7030|007|Z|professional for complete information about this product and your||
7030|008|Z|specific health needs.||
7030|009|B|||
7030|010|T|BRIMONIDINE SOLUTION - OPHTHALMIC||
7030|011|F|(bri-MOE-ni-deen)||
7030|012|B|||
7030|013|C|COMMON BRAND NAME(S): Alphagan P||
7030|014|B|||
7030|015|U|USES:  This medication is used to treat open-angle glaucoma or||
7030|016|U|high fluid pressure in the eye. Lowering high fluid pressure in||
7030|017|U|the eye reduces the risk of vision loss, nerve damage, or||
7030|018|U|blindness. This medication lowers pressure by allowing better||
7030|019|U|fluid drainage from within the eye and also by reducing the||
7030|020|U|amount of fluid formed in the eye. It is known as an alpha||
7030|021|U|agonist.||
7030|022|U|   This drug is not recommended for use in children less than 2||
7030|023|U|years of age due to an increased risk of serious side effects||
7030|024|U|such as very slowed breathing. Ask the doctor or pharmacist for||
7030|025|U|details.||
7030|026|B|||
7030|027|H|HOW TO USE:  Use this medication in the affected eye(s) as||
7030|028|H|directed by your doctor, usually three times daily.||
7030|029|H|   To apply eye drops, wash your hands first. To avoid||
7030|030|H|contamination, do not touch the dropper tip or let it touch your||
7030|031|H|eye or any other surface.||
7030|032|H|   If you are wearing contact lenses, remove them before using||
7030|033|H|this medication. After applying this medication, wait at least 15||
7030|034|H|minutes before putting in your contact lens.||
7030|035|H|   Tilt your head back, look upward and pull down the lower||
7030|036|H|eyelid to make a pouch. Hold the dropper directly over your eye||
7030|037|H|and insert one drop. Look downward and gently close your eyes for||
7030|038|H|1 to 2 minutes. Place one finger at the corner of your eye (near||
7030|039|H|the nose) and apply gentle pressure. Try not to blink and do not||
7030|040|H|rub your eye. This will prevent the medication from draining out.||
7030|041|H|Repeat these steps for your other eye if so directed by your||
7030|042|H|doctor.||
7030|043|H|   Do not rinse the dropper. Replace the dropper cap after each||
7030|044|H|use.||
7030|045|H|   If you are using another kind of eye medication (such as drops||
7030|046|H|or ointments), wait at least 5 minutes before applying the other||
7030|047|H|medications. Use eye drops before eye ointments to allow the eye||
7030|048|H|drops to enter the eye.||
7030|049|H|   Wait several minutes for your vision to clear before driving||
7030|050|H|or operating machinery.||
7030|051|H|   Keep using this medication even if you feel well. Use this||
7030|052|H|medication regularly in order to get the most benefit from it.||
7030|053|H|Remember to use it at the same times each day. Do not stop using||
7030|054|H|this medication without consulting your doctor.||
7030|055|H|   Tell your doctor if your condition gets worse.||
7030|056|B|||
7030|057|S|SIDE EFFECTS:  Eye discomfort/itching/redness, blurred vision,||
7030|058|S|dizziness, dry mouth, bad taste in the mouth, drowsiness, or||
7030|059|S|tiredness may occur. If any of these effects last or get worse,||
7030|060|S|tell your doctor or pharmacist promptly.||
7030|061|S|   Remember that this medication has been prescribed because your||
7030|062|S|doctor has judged that the benefit to you is greater than the||
7030|063|S|risk of side effects. Many people using this medication do not||
7030|064|S|have serious side effects.||
7030|065|S|   Tell your doctor right away if you have any serious side||
7030|066|S|effects, including: headache that doesn't go away, fast/pounding||
7030|067|S|heartbeats, eye pain/burning/swelling, extreme sensitivity to||
7030|068|S|light, vision changes, fainting, slow/irregular heartbeats.||
7030|069|S|   A very serious allergic reaction to this drug is rare.||
7030|070|S|However, get medical help right away if you notice any symptoms||
7030|071|S|of a serious allergic reaction, including: rash, itching/swelling||
7030|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7030|073|S|breathing.||
7030|074|S|   This is not a complete list of possible side effects. If you||
7030|075|S|notice other effects not listed above, contact your doctor or||
7030|076|S|pharmacist.||
7030|077|S|   In the US -||
7030|078|S|   Call your doctor for medical advice about side effects. You||
7030|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7030|080|S|www.fda.gov/medwatch.||
7030|081|S|   In Canada - Call your doctor for medical advice about side||
7030|082|S|effects. You may report side effects to Health Canada at||
7030|083|S|1-866-234-2345.||
7030|084|B|||
7030|085|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
7030|086|P|pharmacist if you are allergic to it; or to apraclonidine; or if||
7030|087|P|you have any other allergies. This product may contain inactive||
7030|088|P|ingredients, which can cause allergic reactions or other||
7030|089|P|problems. Talk to your pharmacist for more details.||
7030|090|P|   Before using this medication, tell your doctor or pharmacist||
7030|091|P|your medical history, especially of: blood vessel diseases||
7030|092|P|(thromboangiitis obliterans), blood circulation disorders||
7030|093|P|(cerebral or coronary insufficiency), depression, severe heart||
7030|094|P|disease, kidney disease, liver disease, Raynaud's disease, low||
7030|095|P|blood pressure upon standing (orthostatic hypotension).||
7030|096|P|   This drug may make you dizzy or drowsy or temporarily blur||
7030|097|P|your vision. Do not drive, use machinery, or do anything that||
7030|098|P|needs alertness or clear vision until you can do it safely. Limit||
7030|099|P|alcoholic beverages. Talk to your doctor if you are using||
7030|100|P|marijuana (cannabis).||
7030|101|P|   Children may be more sensitive to the side effects of this||
7030|102|P|drug, especially drowsiness.||
7030|103|P|   During pregnancy, this medication should be used only when||
7030|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
7030|105|P|   It is unknown if this medication passes into breast milk.||
7030|106|P|Consult your doctor before breastfeeding.||
7030|107|B|||
7030|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7030|109|I|medications work or increase your risk for serious side effects.||
7030|110|I|This document does not contain all possible drug interactions.||
7030|111|I|Keep a list of all the products you use (including||
7030|112|I|prescription/nonprescription drugs and herbal products) and share||
7030|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
7030|114|I|the dosage of any medicines without your doctor's approval.||
7030|115|I|   Some products that may interact with this drug include:||
7030|116|I|beta-blockers (such as atenolol, metoprolol, timolol eye drops),||
7030|117|I|digoxin, high blood pressure medications (such as clonidine,||
7030|118|I|terazosin), tricyclic antidepressants (such as amitriptyline).||
7030|119|I|   Tell your doctor or pharmacist if you are using other products||
7030|120|I|that cause drowsiness such as opioid pain or cough relievers||
7030|121|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
7030|122|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
7030|123|I|zolpidem), muscle relaxants (such as carisoprodol,||
7030|124|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7030|125|I|diphenhydramine).||
7030|126|I|   Check the labels on all your medicines (such as allergy or||
7030|127|I|cough-and-cold products) because they may contain ingredients||
7030|128|I|that cause drowsiness. Ask your pharmacist about using those||
7030|129|I|products safely.||
7030|130|B|||
7030|131|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7030|132|O|has overdosed and has serious symptoms such as passing out or||
7030|133|O|trouble breathing, call 911. Otherwise, call a poison control||
7030|134|O|center right away. US residents can call 1-800-222-1222. Canada||
7030|135|O|residents can call 1-844-764-7669.||
7030|136|B|||
7030|137|N|NOTES:  Do not share this medication with others.||
7030|138|N|   Lab and/or medical tests (such as measuring intraocular||
7030|139|N|pressure) should be done while you are using this medication.||
7030|140|N|Keep all medical and lab appointments. Consult your doctor for||
7030|141|N|more details.||
7030|142|B|||
7030|143|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7030|144|D|If it is near the time of the next dose, skip the missed dose.||
7030|145|D|Use your next dose at the regular time. Do not double the dose to||
7030|146|D|catch up.||
7030|147|B|||
7030|148|R|STORAGE:  Store at room temperature. Keep all medications away||
7030|149|R|from children and pets.||
7030|150|R|   Do not flush medications down the toilet or pour them into a||
7030|151|R|drain unless instructed to do so. Properly discard this product||
7030|152|R|when it is expired or no longer needed. Consult your pharmacist||
7030|153|R|or local waste disposal company.||
7030|154|B|||
7030|155|A|Information last revised November 2024.||
7030|156|A|Copyright(c) 2025 First Databank, Inc.||
7030|157|B|||
7033|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7033|002|Z|does NOT have all possible information about this product. This||
7033|003|Z|information does not assure that this product is safe, effective,||
7033|004|Z|or appropriate for you. This information is not individual||
7033|005|Z|medical advice and does not substitute for the advice of your||
7033|006|Z|health care professional. Always ask your health care||
7033|007|Z|professional for complete information about this product and your||
7033|008|Z|specific health needs.||
7033|009|B|||
7033|010|T|RANITIDINE TABLET - ORAL||
7033|011|F|(ra-NI-ti-deen)||
7033|012|B|||
7033|013|C|COMMON BRAND NAME(S): Zantac||
7033|014|B|||
7033|015|U|USES:  Ranitidine is used to treat ulcers of the stomach and||
7033|016|U|intestines and prevent them from coming back after they have||
7033|017|U|healed. This medication is also used to treat certain stomach and||
7033|018|U|throat (esophagus) problems (such as erosive esophagitis,||
7033|019|U|gastroesophageal reflux disease-GERD, Zollinger-Ellison||
7033|020|U|syndrome). It works by decreasing the amount of acid your stomach||
7033|021|U|makes. It relieves symptoms such as cough that doesn't go away,||
7033|022|U|stomach pain, heartburn, and difficulty swallowing. Ranitidine||
7033|023|U|belongs to a class of drugs known as H2 blockers.||
7033|024|U|   This medication is also available without a prescription. It||
7033|025|U|is used to prevent and treat heartburn and other symptoms caused||
7033|026|U|by too much acid in the stomach (acid indigestion). If you are||
7033|027|U|taking this medication for self-treatment, it is important to||
7033|028|U|read the manufacturer's package instructions carefully so you||
7033|029|U|know when to consult your doctor or pharmacist.||
7033|030|B|||
7033|031|H|HOW TO USE:  Take this medication by mouth with or without food||
7033|032|H|as directed by your doctor, usually once or twice daily. It may||
7033|033|H|be prescribed 4 times a day for some conditions. If you are||
7033|034|H|taking this medication once daily, it is usually taken after the||
7033|035|H|evening meal or before bedtime.||
7033|036|H|   The dosage and length of treatment are based on your medical||
7033|037|H|condition and response to treatment. Children's dosage may also||
7033|038|H|be based on weight. Follow your doctor's instructions carefully.||
7033|039|H|You may take other medications (such as antacids) for your||
7033|040|H|condition as recommended by your doctor.||
7033|041|H|   Take this medication regularly in order to get the most||
7033|042|H|benefit from it. To help you remember, take it at the same||
7033|043|H|time(s) each day. Do not increase your dose or take it more often||
7033|044|H|than prescribed. Do not stop taking this without your doctor's||
7033|045|H|approval because this may delay healing of the ulcer.||
7033|046|H|   If you are using nonprescription ranitidine for self-treatment||
7033|047|H|of acid indigestion or heartburn, take 1 tablet by mouth with a||
7033|048|H|glass of water as needed. To prevent heartburn, take 1 tablet by||
7033|049|H|mouth with a glass of water 30-60 minutes before eating food or||
7033|050|H|drinking beverages that cause heartburn. Do not take more than 2||
7033|051|H|tablets in 24 hours unless directed by your doctor. Do not take||
7033|052|H|for more than 14 days in a row without talking with your doctor.||
7033|053|H|   Tell your doctor if your condition does not get better or if||
7033|054|H|it gets worse.||
7033|055|B|||
7033|056|S|SIDE EFFECTS:  Headache, constipation or diarrhea may occur. If||
7033|057|S|any of these effects last or get worse, tell your doctor or||
7033|058|S|pharmacist promptly.||
7033|059|S|   If your doctor has directed you to use this medication,||
7033|060|S|remember that your doctor has judged that the benefit to you is||
7033|061|S|greater than the risk of side effects. Many people using this||
7033|062|S|medication do not have serious side effects.||
7033|063|S|   Tell your doctor right away if you have any serious side||
7033|064|S|effects, including: blurred vision, mental/mood changes (such as||
7033|065|S|agitation, confusion, depression, hallucinations), easy||
7033|066|S|bleeding/bruising, enlarged breasts, severe tiredness,||
7033|067|S|fast/slow/irregular heartbeat, signs of infection (such as sore||
7033|068|S|throat that doesn't go away, fever, chills), severe||
7033|069|S|stomach/abdominal pain, dark urine, yellowing skin/eyes.||
7033|070|S|   A very serious allergic reaction to this drug is rare.||
7033|071|S|However, get medical help right away if you notice any symptoms||
7033|072|S|of a serious allergic reaction, including: rash, itching/swelling||
7033|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7033|074|S|breathing.||
7033|075|S|   This is not a complete list of possible side effects. If you||
7033|076|S|notice other effects not listed above, contact your doctor or||
7033|077|S|pharmacist.||
7033|078|S|   In the US -||
7033|079|S|   Call your doctor for medical advice about side effects. You||
7033|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7033|081|S|www.fda.gov/medwatch.||
7033|082|S|   In Canada - Call your doctor for medical advice about side||
7033|083|S|effects. You may report side effects to Health Canada at||
7033|084|S|1-866-234-2345.||
7033|085|B|||
7033|086|P|PRECAUTIONS:  Before taking ranitidine, tell your doctor or||
7033|087|P|pharmacist if you are allergic to it; or to other H2 blockers||
7033|088|P|(such as cimetidine, famotidine); or if you have any other||
7033|089|P|allergies. This product may contain inactive ingredients, which||
7033|090|P|can cause allergic reactions or other problems. Talk to your||
7033|091|P|pharmacist for more details.||
7033|092|P|   Before using this medication, tell your doctor or pharmacist||
7033|093|P|your medical history, especially of: a certain blood disorder||
7033|094|P|(porphyria), immune system problems, kidney problems, liver||
7033|095|P|problems, lung diseases (such as asthma, chronic obstructive||
7033|096|P|pulmonary disease-COPD), other stomach problems (such as tumors).||
7033|097|P|   Some symptoms may actually be signs of a more serious||
7033|098|P|condition. Get medical help right away if you have: heartburn||
7033|099|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
7033|100|P|pain (especially with shortness of breath, unusual sweating),||
7033|101|P|unexplained weight loss.||
7033|102|P|   In addition, before you self-treat with this medication, get||
7033|103|P|medical help right away if you have any of these signs of a||
7033|104|P|serious condition: trouble/pain swallowing food, bloody vomit,||
7033|105|P|vomit that looks like coffee grounds, bloody/black stools,||
7033|106|P|heartburn for over 3 months, frequent chest pain, frequent||
7033|107|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
7033|108|P|pain.||
7033|109|P|   Before having surgery, tell your doctor or dentist about all||
7033|110|P|the products you use (including prescription drugs,||
7033|111|P|nonprescription drugs, and herbal products).||
7033|112|P|   Older adults may be more sensitive to the side effects of this||
7033|113|P|drug, especially confusion.||
7033|114|P|   During pregnancy, ranitidine should be used only when clearly||
7033|115|P|needed. Discuss the risks and benefits with your doctor.||
7033|116|P|   Ranitidine passes into breast milk. Consult your doctor before||
7033|117|P|breastfeeding.||
7033|118|B|||
7033|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7033|120|I|medications work or increase your risk for serious side effects.||
7033|121|I|This document does not contain all possible drug interactions.||
7033|122|I|Keep a list of all the products you use (including||
7033|123|I|prescription/nonprescription drugs and herbal products) and share||
7033|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
7033|125|I|the dosage of any medicines without your doctor's approval.||
7033|126|I|   Some products need stomach acid so that the body can absorb||
7033|127|I|them properly. Ranitidine decreases stomach acid, so it may||
7033|128|I|change how well these products work. Some affected products||
7033|129|I|include atazanavir, dasatinib, certain azole antifungals (such as||
7033|130|I|itraconazole, ketoconazole), levoketoconazole, pazopanib,||
7033|131|I|sparsentan, among others.||
7033|132|I|   Do not use this medication with other products that contain||
7033|133|I|ranitidine or other H2 blockers (cimetidine, famotidine,||
7033|134|I|nizatidine).||
7033|135|I|   This medication may interfere with certain lab tests (such as||
7033|136|I|urine protein tests), possibly causing false test results. Make||
7033|137|I|sure lab personnel and all your doctors know you use this drug.||
7033|138|B|||
7033|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7033|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7033|141|O|poison control center right away. US residents can call||
7033|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7033|143|O|Symptoms of overdose may include difficulty walking, severe||
7033|144|O|dizziness/fainting.||
7033|145|B|||
7033|146|N|NOTES:  Do not share this medication with others.||
7033|147|N|   Lifestyle changes such as stress reduction programs, stopping||
7033|148|N|smoking, limiting alcohol, and diet changes (such as avoiding||
7033|149|N|caffeine and certain spices) may help this medication work||
7033|150|N|better. Talk to your doctor or pharmacist about lifestyle changes||
7033|151|N|that might benefit you.||
7033|152|N|   Lab and/or medical tests (such as endoscopy, kidney function)||
7033|153|N|may be done while you are taking this medication. Keep all||
7033|154|N|medical and lab appointments. Consult your doctor for more||
7033|155|N|details.||
7033|156|B|||
7033|157|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7033|158|D|remember. If it is near the time of the next dose, skip the||
7033|159|D|missed dose. Take your next dose at the regular time. Do not||
7033|160|D|double the dose to catch up.||
7033|161|B|||
7033|162|R|STORAGE:  Different brands of this medication have different||
7033|163|R|storage needs. Check the product package for instructions on how||
7033|164|R|to store your brand, or ask your pharmacist. Keep all medications||
7033|165|R|away from children and pets.||
7033|166|R|   Do not flush medications down the toilet or pour them into a||
7033|167|R|drain unless instructed to do so. Properly discard this product||
7033|168|R|when it is expired or no longer needed. Consult your pharmacist||
7033|169|R|or local waste disposal company.||
7033|170|B|||
7033|171|A|Information last revised November 2025.||
7033|172|A|Copyright(c) 2025 First Databank, Inc.||
7033|173|B|||
7034|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7034|002|Z|does NOT have all possible information about this product. This||
7034|003|Z|information does not assure that this product is safe, effective,||
7034|004|Z|or appropriate for you. This information is not individual||
7034|005|Z|medical advice and does not substitute for the advice of your||
7034|006|Z|health care professional. Always ask your health care||
7034|007|Z|professional for complete information about this product and your||
7034|008|Z|specific health needs.||
7034|009|B|||
7034|010|T|CLOZAPINE - ORAL||
7034|011|F|(KLOE-za-peen)||
7034|012|B|||
7034|013|C|COMMON BRAND NAME(S): Clozaril, Versacloz||
7034|014|B|||
7034|015|W|WARNING:  While clozapine can provide great benefits, it can||
7034|016|W|rarely cause serious, possibly fatal side effects. For this||
7034|017|W|reason, clozapine is used when other treatments have not worked||
7034|018|W|or you cannot take them.||
7034|019|W|   This medication can cause a serious decrease of a certain type||
7034|020|W|of white blood cells (neutropenia). To make sure you have enough||
7034|021|W|white blood cells, your doctor will order lab tests before||
7034|022|W|starting and while your are taking clozapine. Neutropenia may||
7034|023|W|lower your ability to fight infections. This may make you more||
7034|024|W|likely to get a serious (rarely fatal) infection or make any||
7034|025|W|infection you have worse. Get medical help right away if you have||
7034|026|W|any signs of severe neutropenia or infection (such as sore throat||
7034|027|W|that doesn't go away, fever, swollen lymph nodes, unusual||
7034|028|W|tiredness, weakness).||
7034|029|W|   Clozapine can also cause seizures, especially in higher doses.||
7034|030|W|Let your doctor or pharmacist know if you have ever had seizures.||
7034|031|W|While taking this medication, avoid driving or other activities||
7034|032|W|during which a sudden loss of consciousness could be dangerous||
7034|033|W|(such as operating heavy machinery, swimming).||
7034|034|W|   This medication may rarely cause swelling of the heart muscle||
7034|035|W|(myocarditis), swelling of the heart lining (pericarditis), or||
7034|036|W|heart failure. Get medical help right away if you develop chest||
7034|037|W|pain, fast/irregular heartbeat, shortness of breath, swelling||
7034|038|W|ankles/feet, unusual tiredness, or unusual/sudden weight gain.||
7034|039|W|   Clozapine can cause low blood pressure or a slow heartbeat,||
7034|040|W|which can make you dizzy or cause you to faint when you stand up.||
7034|041|W|The risk is higher when you first start or increase your dose of||
7034|042|W|medication. Dizziness and lightheadedness can increase the risk||
7034|043|W|of falling. Get up slowly when rising from a sitting or lying||
7034|044|W|position.||
7034|045|W|   There may be a slightly increased risk of serious, possibly||
7034|046|W|fatal side effects (such as stroke, heart failure, fast/irregular||
7034|047|W|heartbeat, pneumonia) when this medication is used by older||
7034|048|W|adults with dementia. This medication is not approved for the||
7034|049|W|treatment of dementia-related behavior problems. Discuss the||
7034|050|W|risks and benefits of this medication, as well as other effective||
7034|051|W|and possibly safer treatments for dementia-related behavior||
7034|052|W|problems, with the doctor.||
7034|053|B|||
7034|054|U|USES:  See also Warning section.||
7034|055|U|   This medication is used to treat certain mental/mood disorders||
7034|056|U|(schizophrenia, schizoaffective disorders). Clozapine may also||
7034|057|U|help prevent suicide in people who are likely to try to harm||
7034|058|U|themselves. Clozapine belongs to a class of drugs known as||
7034|059|U|atypical antipsychotics. It works by helping to restore the||
7034|060|U|balance of certain natural substances in the brain.||
7034|061|B|||
7034|062|H|HOW TO USE:  Read the Medication Guide and, if available, the||
7034|063|H|Instructions for Use provided by your pharmacist before you start||
7034|064|H|taking clozapine and each time you get a refill. If you have any||
7034|065|H|questions, ask your doctor or pharmacist.||
7034|066|H|   Take this medication by mouth with or without food, as||
7034|067|H|directed by your doctor. If you are taking the tablets that||
7034|068|H|dissolve in the mouth, carefully remove each tablet from the||
7034|069|H|blister pack immediately before taking your dose. Allow the||
7034|070|H|tablets to dissolve on your tongue and swallow. You do not need||
7034|071|H|to take the dissolving tablets with water. Discard any dissolving||
7034|072|H|tablets that have been previously exposed to air due to||
7034|073|H|opened/damaged packaging. Do not save them for your next dose.||
7034|074|H|   If you are using the liquid form of this medication, shake the||
7034|075|H|bottle well for 10 seconds before each use. Carefully measure the||
7034|076|H|dose using a special measuring device/spoon. Do not use a||
7034|077|H|household spoon because you may not get the correct dose.||
7034|078|H|   It is important to begin taking this drug at a low dose,||
7034|079|H|increasing your dose slowly, to lessen side effects such as||
7034|080|H|dizziness, drowsiness and seizures. Follow your doctor's||
7034|081|H|instructions exactly. The dosage is based on your medical||
7034|082|H|condition and response to treatment. Since clozapine can cause a||
7034|083|H|decrease in white blood cells, you will need to get blood tests||
7034|084|H|done regularly as directed. Be sure to keep all appointments for||
7034|085|H|these lab tests. (See also Notes section.)||
7034|086|H|   If you miss your doses for longer than a day or two, consult||
7034|087|H|your doctor for a new schedule to get back to the dose you were||
7034|088|H|on (see Missed Dose section). Use this medication regularly in||
7034|089|H|order to get the most benefit from it. To help you remember, use||
7034|090|H|it at the same time(s) each day.||
7034|091|H|   Do not stop taking clozapine without consulting your doctor.||
7034|092|H|Some conditions may become worse when the drug is suddenly||
7034|093|H|stopped. Also, you may experience symptoms such as severe||
7034|094|H|sweating, headache, nausea, vomiting, and diarrhea. To prevent||
7034|095|H|these symptoms while you are stopping treatment with this drug,||
7034|096|H|your doctor may reduce your dose gradually. Consult your doctor||
7034|097|H|or pharmacist for more details. Report any new or worsening||
7034|098|H|symptoms right away.||
7034|099|H|   It may take several weeks before the full benefit of this drug||
7034|100|H|takes effect. Tell your doctor if your condition lasts or gets||
7034|101|H|worse.||
7034|102|B|||
7034|103|S|SIDE EFFECTS:  See also Warning section.||
7034|104|S|   Drooling, drowsiness, dizziness, lightheadedness, headache,||
7034|105|S|shaking (tremor), vision problems (such as blurred vision),||
7034|106|S|constipation, and weight gain may occur. Many of these effects||
7034|107|S|(especially drowsiness) lessen as your body gets used to the||
7034|108|S|medication. If any of these effects last or get worse, tell your||
7034|109|S|doctor or pharmacist promptly.||
7034|110|S|   To prevent constipation, eat dietary fiber, drink enough||
7034|111|S|water, and exercise. You may also need to take a laxative. Ask||
7034|112|S|your pharmacist which type of laxative is right for you.||
7034|113|S|   Remember that this medication has been prescribed because your||
7034|114|S|doctor has judged that the benefit to you is greater than the||
7034|115|S|risk of side effects. Many people using this medication do not||
7034|116|S|have serious side effects.||
7034|117|S|   This medication may rarely make your blood sugar rise, which||
7034|118|S|can cause or worsen diabetes. Tell your doctor right away if you||
7034|119|S|have symptoms of high blood sugar such as increased||
7034|120|S|thirst/urination. If you already have diabetes, check your blood||
7034|121|S|sugar regularly as directed and share the results with your||
7034|122|S|doctor. Your doctor may need to adjust your diabetes medication,||
7034|123|S|exercise program, or diet.||
7034|124|S|   This drug may also cause significant weight gain and a rise in||
7034|125|S|your cholesterol (or triglyceride) levels. These effects, along||
7034|126|S|with diabetes, may increase your risk for developing heart||
7034|127|S|disease. Discuss the risks and benefits of treatment with your||
7034|128|S|doctor.||
7034|129|S|   Tell your doctor right away if you have any serious side||
7034|130|S|effects, including: facial/muscle twitching, seizures,||
7034|131|S|uncontrollable movements, interrupted breathing during sleep,||
7034|132|S|trouble urinating, severe constipation.||
7034|133|S|   Get medical help right away if you have any very serious side||
7034|134|S|effects, including: nausea/vomiting that doesn't stop, severe||
7034|135|S|dizziness, fainting, mental/mood changes, difficulty breathing||
7034|136|S|with exercise, sudden weakness, pain/redness/swelling of the||
7034|137|S|arms/legs, stomach/abdominal pain, yellowing of eyes/skin.||
7034|138|S|   This medication may rarely cause a very serious condition||
7034|139|S|called neuroleptic malignant syndrome (NMS). Get medical help||
7034|140|S|right away if you have any of the following symptoms: fever,||
7034|141|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
7034|142|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
7034|143|S|signs of kidney problems (such as change in the amount of urine).||
7034|144|S|   A very serious allergic reaction to this drug is rare.||
7034|145|S|However, get medical help right away if you notice any symptoms||
7034|146|S|of a serious allergic reaction, including: rash, itching/swelling||
7034|147|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7034|148|S|breathing.||
7034|149|S|   This is not a complete list of possible side effects. If you||
7034|150|S|notice other effects not listed above, contact your doctor or||
7034|151|S|pharmacist.||
7034|152|S|   In the US -||
7034|153|S|   Call your doctor for medical advice about side effects. You||
7034|154|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7034|155|S|www.fda.gov/medwatch.||
7034|156|S|   In Canada - Call your doctor for medical advice about side||
7034|157|S|effects. You may report side effects to Health Canada at||
7034|158|S|1-866-234-2345.||
7034|159|B|||
7034|160|P|PRECAUTIONS:  See also Warning and Side Effects sections.||
7034|161|P|   Before taking clozapine, tell your doctor or pharmacist if you||
7034|162|P|are allergic to it or if you have any other allergies. This||
7034|163|P|product may contain inactive ingredients, which can cause||
7034|164|P|allergic reactions or other problems. Talk to your pharmacist for||
7034|165|P|more details.||
7034|166|P|   Before using this medication, tell your doctor or pharmacist||
7034|167|P|your medical history, especially of: history of blood disorders||
7034|168|P|(such as leukemia, low white blood cell count), bowel problems||
7034|169|P|(such as paralytic ileus, irritable bowel syndrome ), breathing||
7034|170|P|problems, diabetes/family history of diabetes, high||
7034|171|P|cholesterol/triglyceride levels, glaucoma, heart problems, kidney||
7034|172|P|problems, liver problems, obesity/family history of obesity,||
7034|173|P|seizures, difficulty urinating (for example, due to enlarged||
7034|174|P|prostate), breathing trouble during sleep (sleep apnea).||
7034|175|P|   Clozapine may cause a condition that affects the heart rhythm||
7034|176|P|(QT prolongation). QT prolongation can rarely cause serious||
7034|177|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
7034|178|P|as severe dizziness, fainting) that need medical attention right||
7034|179|P|away.||
7034|180|P|   The risk of QT prolongation may be increased if you have||
7034|181|P|certain medical conditions or are taking other drugs that may||
7034|182|P|affect the heart rhythm. Before using clozapine, tell your doctor||
7034|183|P|or pharmacist of all the drugs you take and if you have any of||
7034|184|P|the following conditions: certain heart problems (heart failure,||
7034|185|P|slow heartbeat, QT prolongation in the EKG), family history of||
7034|186|P|certain heart problems (QT prolongation in the EKG, sudden||
7034|187|P|cardiac death).||
7034|188|P|   Low levels of potassium or magnesium in the blood may also||
7034|189|P|increase your risk of QT prolongation. This risk may increase if||
7034|190|P|you use certain drugs (such as diuretics/"water pills") or if you||
7034|191|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7034|192|P|Talk to your doctor about using clozapine safely.||
7034|193|P|   This drug may make you dizzy or drowsy or blur your vision.||
7034|194|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7034|195|P|drowsy. Do not drive, use machinery, or do anything that needs||
7034|196|P|alertness or clear vision until you can do it safely. Limit||
7034|197|P|alcoholic beverages. Talk to your doctor if you are using||
7034|198|P|marijuana (cannabis).||
7034|199|P|   Tell your doctor if you are a descendent of Ashkenazi Jews||
7034|200|P|because you may be at a higher risk for a drop in your white||
7034|201|P|blood cells.||
7034|202|P|   Before having surgery, tell your doctor or dentist about all||
7034|203|P|the products you use (including prescription drugs,||
7034|204|P|nonprescription drugs, and herbal products).||
7034|205|P|   Liquid products or dissolving tablets may contain sugar and/or||
7034|206|P|aspartame. Liquid products may also contain alcohol. Caution is||
7034|207|P|advised if you have diabetes, liver disease, phenylketonuria||
7034|208|P|(PKU), or any other condition that requires you to limit/avoid||
7034|209|P|these substances in your diet. Ask your doctor or pharmacist||
7034|210|P|about using this product safely.||
7034|211|P|   Older adults may be more sensitive to the side effects of this||
7034|212|P|drug, especially constipation, trouble urinating, drowsiness,||
7034|213|P|dizziness, lightheadedness, and QT prolongation (see above).||
7034|214|P|Drowsiness, dizziness, and lightheadedness can increase the risk||
7034|215|P|of falling.||
7034|216|P|   During pregnancy, this medication should be used only when||
7034|217|P|clearly needed. Babies born to mothers who have used this drug||
7034|218|P|during the last 3 months of pregnancy may rarely develop symptoms||
7034|219|P|including muscle stiffness or shakiness, drowsiness,||
7034|220|P|feeding/breathing difficulties, or constant crying. If you notice||
7034|221|P|any of these symptoms in your newborn especially during their||
7034|222|P|first month, tell the doctor right away.||
7034|223|P|   Since untreated mental/mood problems (such as schizophrenia,||
7034|224|P|schizoaffective disorders) can be a serious condition, do not||
7034|225|P|stop taking this medication unless directed by your doctor. If||
7034|226|P|you are planning pregnancy, become pregnant, or think you may be||
7034|227|P|pregnant, immediately discuss with your doctor the benefits and||
7034|228|P|risks of using this medication during pregnancy.||
7034|229|P|   Clozapine passes into breast milk and may have undesirable||
7034|230|P|effects on a nursing infant. Breastfeeding is not recommended||
7034|231|P|while using this medication. Consult your doctor before||
7034|232|P|breastfeeding.||
7034|233|B|||
7034|234|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7034|235|I|medications work or increase your risk for serious side effects.||
7034|236|I|This document does not contain all possible drug interactions.||
7034|237|I|Keep a list of all the products you use (including||
7034|238|I|prescription/nonprescription drugs and herbal products) and share||
7034|239|I|it with your doctor and pharmacist. Do not start, stop, or change||
7034|240|I|the dosage of any medicines without your doctor's approval.||
7034|241|I|   A product that may interact with this drug is: metoclopramide.||
7034|242|I|   Other medications can affect the removal of clozapine from||
7034|243|I|your body, which may affect how clozapine works. Examples include||
7034|244|I|fluvoxamine, St. John's wort, drugs used to treat seizures (such||
7034|245|I|as carbamazepine, phenytoin), among others.||
7034|246|I|   Tell your doctor or pharmacist if you are taking other||
7034|247|I|products that cause drowsiness such as opioid pain or cough||
7034|248|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7034|249|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
7034|250|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7034|251|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7034|252|I|diphenhydramine).||
7034|253|I|   Check the labels on all your medicines (such as allergy or||
7034|254|I|cough-and-cold products) because they may contain ingredients||
7034|255|I|that cause drowsiness. Ask your pharmacist about using those||
7034|256|I|products safely.||
7034|257|I|   Cigarette smoking decreases blood levels of this medication.||
7034|258|I|Tell your doctor if you smoke or if you have recently stopped||
7034|259|I|smoking.||
7034|260|B|||
7034|261|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7034|262|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7034|263|O|poison control center right away. US residents can call||
7034|264|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7034|265|O|Symptoms of overdose may include: severe dizziness,||
7034|266|O|fast/irregular heartbeat, seizures, trouble breathing.||
7034|267|B|||
7034|268|N|NOTES:  Do not share this medication with others.||
7034|269|N|   Lab and/or medical tests (such as complete blood count, liver||
7034|270|N|function, blood sugar, weight, cholesterol/triglyceride levels)||
7034|271|N|must be done before you start taking this medication and while||
7034|272|N|you are taking it. Clozapine blood levels may also be checked.||
7034|273|N|Keep all medical and lab appointments. Consult your doctor for||
7034|274|N|more details.||
7034|275|B|||
7034|276|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7034|277|D|remember. If it is near the time of the next dose, skip the||
7034|278|D|missed dose. Take your next dose at the regular time. If you miss||
7034|279|D|doses for longer than a day or two, consult your doctor for a new||
7034|280|D|schedule to get back to the dose you were taking. Do not double||
7034|281|D|the dose to catch up.||
7034|282|B|||
7034|283|R|STORAGE:  Store at room temperature away from light and moisture.||
7034|284|R|Keep the dissolving tablets in their blister packets until ready||
7034|285|R|to use. Do not refrigerate or freeze the liquid form. Keep the||
7034|286|R|liquid form in the original carton to protect from light and use||
7034|287|R|within 100 days of opening the bottle. Do not store in the||
7034|288|R|bathroom. Keep all medications away from children and pets.||
7034|289|R|   Do not flush medications down the toilet or pour them into a||
7034|290|R|drain unless instructed to do so. Properly discard this product||
7034|291|R|when it is expired or no longer needed. Consult your pharmacist||
7034|292|R|or local waste disposal company.||
7034|293|B|||
7034|294|A|Information last revised June 2025.||
7034|295|A|Copyright(c) 2025 First Databank, Inc.||
7034|296|B|||
7037|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7037|002|Z|does NOT have all possible information about this product. This||
7037|003|Z|information does not assure that this product is safe, effective,||
7037|004|Z|or appropriate for you. This information is not individual||
7037|005|Z|medical advice and does not substitute for the advice of your||
7037|006|Z|health care professional. Always ask your health care||
7037|007|Z|professional for complete information about this product and your||
7037|008|Z|specific health needs.||
7037|009|B|||
7037|010|T|INSULIN GLARGINE - INJECTION||
7037|011|F|(IN-su-lin GLAR-jeen)||
7037|012|B|||
7037|013|C|COMMON BRAND NAME(S): Basaglar, Lantus, Rezvoglar, Semglee||
7037|014|B|||
7037|015|U|USES:  Insulin glargine is used with a proper diet and exercise||
7037|016|U|program to control high blood sugar in people with diabetes.||
7037|017|U|Controlling high blood sugar helps prevent kidney damage,||
7037|018|U|blindness, nerve problems, loss of limbs, and sexual function||
7037|019|U|problems. Proper control of diabetes may also lessen your risk of||
7037|020|U|a heart attack or stroke.||
7037|021|U|   Insulin glargine is a man-made product that is similar to||
7037|022|U|human insulin. It replaces the insulin that your body would||
7037|023|U|normally make. It acts longer than regular insulin, providing a||
7037|024|U|low, steady level of insulin. It works by helping blood sugar||
7037|025|U|(glucose) get into cells so your body can use it for energy.||
7037|026|U|Insulin glargine may be used with a shorter-acting insulin||
7037|027|U|product. It may also be used alone or with other diabetes drugs.||
7037|028|U|   This monograph is about the following insulin glargine||
7037|029|U|products: insulin glargine, insulin glargine-aglr, and insulin||
7037|030|U|glargine-yfgn.||
7037|031|B|||
7037|032|H|HOW TO USE:  Read the Patient Information Leaflet and||
7037|033|H|Instructions for Use if available from your pharmacist before you||
7037|034|H|start using this medication and each time you get a refill. Ask||
7037|035|H|your health care professional how to prepare and use this||
7037|036|H|medication. If you have any questions, ask your doctor or||
7037|037|H|pharmacist.||
7037|038|H|   Inject this medication under the skin as directed by your||
7037|039|H|doctor, usually once daily. The injection is given in the stomach||
7037|040|H|area, the thigh, or the back of the upper arm. Do not inject into||
7037|041|H|a vein or muscle because very low blood sugar (hypoglycemia) may||
7037|042|H|occur. The dosage is based on your medical condition and response||
7037|043|H|to treatment. Measure each dose very carefully because even small||
7037|044|H|changes in the amount of insulin may have a large effect on your||
7037|045|H|blood sugar.||
7037|046|H|   Before using, check this product for particles or||
7037|047|H|discoloration. If either is present, do not use the insulin.||
7037|048|H|Before injecting each dose, clean the skin you are going to||
7037|049|H|inject into (the injection site) with rubbing alcohol. Change the||
7037|050|H|injection site each time to lessen injury under the skin (for||
7037|051|H|example, pits/lumps or thickened skin). Do not inject into skin||
7037|052|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
7037|053|H|not rub the injection site after a shot. Do not inject cold||
7037|054|H|insulin because this can be painful. The insulin container you||
7037|055|H|are currently using can be kept at room temperature. Learn how to||
7037|056|H|store and discard medical supplies safely.||
7037|057|H|   Do not mix this product with other insulins or solutions, or||
7037|058|H|use it in an insulin pump.||
7037|059|H|   Do not change brands or types of insulin without directions on||
7037|060|H|how to do so from your doctor.||
7037|061|H|   Do not share your pen device with another person, even if the||
7037|062|H|needle is changed. You may give other people a serious infection,||
7037|063|H|or get a serious infection from them.||
7037|064|H|   Use this medication regularly to get the most benefit from it.||
7037|065|H|To help you remember, use it at the same time each day.||
7037|066|H|   Tell your doctor if your condition does not get better or if||
7037|067|H|it gets worse (your blood sugar is too high or too low).||
7037|068|B|||
7037|069|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
7037|070|S|irritation) or weight gain may occur. If any of these effects||
7037|071|S|last or get worse, tell your doctor or pharmacist promptly.||
7037|072|S|   Remember that this medication has been prescribed because your||
7037|073|S|doctor has judged that the benefit to you is greater than the||
7037|074|S|risk of side effects. Many people using this medication do not||
7037|075|S|have serious side effects.||
7037|076|S|   Tell your doctor right away if you have any serious side||
7037|077|S|effects, including: signs of low potassium level in the blood||
7037|078|S|(such as muscle cramps, weakness, irregular heartbeat).||
7037|079|S|   This medication can cause low blood sugar (hypoglycemia). This||
7037|080|S|may occur if you do not get enough calories from food or if you||
7037|081|S|do unusually heavy exercise. Symptoms of low blood sugar include||
7037|082|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
7037|083|S|dizziness, or tingling hands/feet. It is a good habit to carry||
7037|084|S|glucose tablets or gel to treat low blood sugar. If you don't||
7037|085|S|have these reliable forms of glucose, rapidly raise your blood||
7037|086|S|sugar by eating a quick source of sugar such as table sugar,||
7037|087|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
7037|088|S|doctor right away about the reaction and the use of this product.||
7037|089|S|To help prevent low blood sugar, eat meals on a regular schedule,||
7037|090|S|and do not skip meals. Check with your doctor or pharmacist to||
7037|091|S|find out what you should do if you miss a meal.||
7037|092|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
7037|093|S|thirst/urination. If these symptoms occur, tell your doctor right||
7037|094|S|away. Your doctor may need to adjust your diabetes medication,||
7037|095|S|exercise program, or diet.||
7037|096|S|   A very serious allergic reaction to this drug is rare.||
7037|097|S|However, get medical help right away if you notice any symptoms||
7037|098|S|of a serious allergic reaction, including: rash, itching/swelling||
7037|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7037|100|S|breathing.||
7037|101|S|   This is not a complete list of possible side effects. If you||
7037|102|S|notice other effects not listed above, contact your doctor or||
7037|103|S|pharmacist.||
7037|104|S|   In the US -||
7037|105|S|   Call your doctor for medical advice about side effects. You||
7037|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7037|107|S|www.fda.gov/medwatch.||
7037|108|S|   In Canada - Call your doctor for medical advice about side||
7037|109|S|effects. You may report side effects to Health Canada at||
7037|110|S|1-866-234-2345.||
7037|111|B|||
7037|112|P|PRECAUTIONS:  Before using insulin glargine, tell your doctor or||
7037|113|P|pharmacist if you are allergic to it; or to other types of||
7037|114|P|insulins; or if you have any other allergies. This product may||
7037|115|P|contain inactive ingredients, which can cause allergic reactions||
7037|116|P|or other problems. Talk to your pharmacist for more details.||
7037|117|P|   Do not use this medication when you have low blood sugar||
7037|118|P|(hypoglycemia).||
7037|119|P|   Before using this medication, tell your doctor or pharmacist||
7037|120|P|your medical history, especially of: kidney disease, liver||
7037|121|P|disease.||
7037|122|P|   You may experience blurred vision, dizziness, or drowsiness||
7037|123|P|due to extremely low or high blood sugar. Do not drive, use||
7037|124|P|machinery, or do anything that needs alertness or clear vision||
7037|125|P|until you can do it safely.||
7037|126|P|   Limit alcohol while taking this medication because it can||
7037|127|P|increase the risk of developing low blood sugar.||
7037|128|P|   It may be harder to control your blood sugar when your body is||
7037|129|P|stressed (such as due to fever, infection, injury, or surgery).||
7037|130|P|Consult your doctor because this may require a change in your||
7037|131|P|treatment plan, medications, or blood sugar testing.||
7037|132|P|   Before having surgery, tell your doctor or dentist about all||
7037|133|P|the products you use (including prescription drugs,||
7037|134|P|nonprescription drugs, and herbal products).||
7037|135|P|   Check your blood sugar before and after exercise. You may need||
7037|136|P|a snack before exercising.||
7037|137|P|   If traveling across time zones, ask your doctor about how to||
7037|138|P|adjust your insulin schedule. Take extra insulin and supplies||
7037|139|P|with you.||
7037|140|P|   Older adults may be more sensitive to the side effects of this||
7037|141|P|drug, especially low blood sugar.||
7037|142|P|   Children may be more sensitive to the side effects of this||
7037|143|P|drug, especially low blood sugar.||
7037|144|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
7037|145|P|cause or worsen diabetes. Discuss a plan with your doctor for||
7037|146|P|managing your blood sugar while pregnant. Your doctor may change||
7037|147|P|your diabetes treatment during your pregnancy (such as diet and||
7037|148|P|medications including insulin).||
7037|149|P|   This medication passes into breast milk, but is unlikely to||
7037|150|P|harm a nursing infant. Consult your doctor before breastfeeding.||
7037|151|P|Your insulin needs may change while breastfeeding.||
7037|152|B|||
7037|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7037|154|I|medications work or increase your risk for serious side effects.||
7037|155|I|This document does not contain all possible drug interactions.||
7037|156|I|Keep a list of all the products you use (including||
7037|157|I|prescription/nonprescription drugs and herbal products) and share||
7037|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
7037|159|I|the dosage of any medicines without your doctor's approval.||
7037|160|I|   Beta-blocker medications (such as metoprolol, propranolol,||
7037|161|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
7037|162|I|heartbeat you would usually feel when your blood sugar falls too||
7037|163|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
7037|164|I|dizziness, hunger, or sweating are unaffected by these drugs.||
7037|165|I|   Many drugs can affect your blood sugar, making it harder to||
7037|166|I|control. Before you start, stop, or change any medication, talk||
7037|167|I|with your doctor or pharmacist about how the medication may||
7037|168|I|affect your blood sugar. Check your blood sugar regularly as||
7037|169|I|directed and share the results with your doctor. Tell your doctor||
7037|170|I|right away if you have symptoms of high or low blood sugar. (See||
7037|171|I|also Side Effects section.) Your doctor may need to adjust your||
7037|172|I|diabetes medication, exercise program, or diet.||
7037|173|B|||
7037|174|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7037|175|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7037|176|O|poison control center right away. US residents can call||
7037|177|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7037|178|O|Symptoms of overdose may include: signs of low blood sugar such||
7037|179|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
7037|180|B|||
7037|181|N|NOTES:  Do not share this medication, needles, or syringes with||
7037|182|N|others.||
7037|183|N|   Attend a diabetes education program to learn more about how to||
7037|184|N|manage your diabetes with medications, diet, exercise, and||
7037|185|N|regular medical exams.||
7037|186|N|   Learn the symptoms of high and low blood sugar and how to||
7037|187|N|treat low blood sugar. Check your blood sugar regularly as||
7037|188|N|directed and share the results with your doctor.||
7037|189|N|   Lab and/or medical tests (such as liver/kidney function,||
7037|190|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
7037|191|N|should be done while you are taking this medication. Keep all||
7037|192|N|medical and lab appointments.||
7037|193|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
7037|194|B|||
7037|195|D|MISSED DOSE:  It is very important to follow your insulin regimen||
7037|196|D|exactly. Ask your doctor ahead of time what you should do if you||
7037|197|D|miss a dose of insulin.||
7037|198|B|||
7037|199|R|STORAGE:  Store all unopened insulin containers in the||
7037|200|R|refrigerator. Do not freeze, and do not use insulin that has been||
7037|201|R|frozen. If you are using the vials, store open vials in the||
7037|202|R|refrigerator or at room temperature. Store vials and pens away||
7037|203|R|from direct heat and light. Store in the carton to protect from||
7037|204|R|light. Do not refrigerate cartridges or pens that are currently||
7037|205|R|in use. Discard all containers in use after 28 days, even if||
7037|206|R|there is insulin left. Also discard all insulin products after||
7037|207|R|the expiration date on the package. Do not store in the bathroom.||
7037|208|R|Keep all medications away from children and pets.||
7037|209|R|   Do not flush medications down the toilet or pour them into a||
7037|210|R|drain unless instructed to do so. Properly discard this product||
7037|211|R|when it is expired or no longer needed. Consult your pharmacist||
7037|212|R|or local waste disposal company.||
7037|213|B|||
7037|214|M|MEDICAL ALERT:  Your condition can cause complications in a||
7037|215|M|medical emergency. For information about enrolling in MedicAlert,||
7037|216|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7037|217|B|||
7037|218|A|Information last revised April 2025.||
7037|219|A|Copyright(c) 2025 First Databank, Inc.||
7037|220|B|||
7038|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7038|002|Z|does NOT have all possible information about this product. This||
7038|003|Z|information does not assure that this product is safe, effective,||
7038|004|Z|or appropriate for you. This information is not individual||
7038|005|Z|medical advice and does not substitute for the advice of your||
7038|006|Z|health care professional. Always ask your health care||
7038|007|Z|professional for complete information about this product and your||
7038|008|Z|specific health needs.||
7038|009|B|||
7038|010|T|CALCITRIOL - ORAL||
7038|011|F|(KAL-si-TRYE-ol)||
7038|012|B|||
7038|013|C|COMMON BRAND NAME(S): Rocaltrol||
7038|014|B|||
7038|015|U|USES:  Calcitriol is a man-made active form of vitamin D. Most||
7038|016|U|people get enough vitamin D from exposure to the sun and from||
7038|017|U|fortified food products (such as dairy products, vitamins).||
7038|018|U|Vitamin D helps control parathyroid hormone and the levels of||
7038|019|U|certain minerals (such as calcium, phosphorus) that are needed||
7038|020|U|for building and keeping strong bones.||
7038|021|U|   Before regular vitamin D can be used by the body, it needs to||
7038|022|U|be changed to the active form by the liver and kidneys.||
7038|023|U|Calcitriol is used in patients with kidney disease who can't make||
7038|024|U|enough of the active form of Vitamin D. This medication is also||
7038|025|U|used to prevent and treat certain types of||
7038|026|U|calcium/phosphorus/parathyroid problems that can happen with||
7038|027|U|long-term kidney dialysis or hypoparathyroidism. Calcitriol is||
7038|028|U|usually used along with specific diet recommendations and||
7038|029|U|sometimes other medications.||
7038|030|B|||
7038|031|V|OTHER USES:  This section contains uses of this drug that are not||
7038|032|V|listed in the approved professional labeling for the drug but||
7038|033|V|that may be prescribed by your health care professional. Use this||
7038|034|V|drug for a condition that is listed in this section only if it||
7038|035|V|has been so prescribed by your health care professional.||
7038|036|V|   This drug may also be used for certain bone diseases (rickets,||
7038|037|V|osteomalacia) when regular vitamin D does not work.||
7038|038|B|||
7038|039|H|HOW TO USE:  Take this medication by mouth with or without food||
7038|040|H|as directed by your doctor, usually once daily. If you are using||
7038|041|H|the liquid form, measure your dose with a special measuring spoon||
7038|042|H|or device. Do not use a normal household spoon since you may not||
7038|043|H|get the correct dose.||
7038|044|H|   The dosage is based on your medical condition and response to||
7038|045|H|treatment. Your doctor may start you on a low dose and adjust the||
7038|046|H|dose slowly to find the best dose for you. Follow your doctor's||
7038|047|H|directions carefully. Use this medication regularly in order to||
7038|048|H|get the most benefit from it. To help you remember, take it at||
7038|049|H|the same time each day.||
7038|050|H|   It is very important to follow the diet recommended by your||
7038|051|H|doctor to get the most benefit from this medication and to||
7038|052|H|prevent serious side effects. Do not take other||
7038|053|H|supplements/vitamins (such as calcium, vitamin D) unless ordered||
7038|054|H|by your doctor.||
7038|055|H|   Certain medications (bile acid sequestrants such as||
7038|056|H|cholestyramine/colestipol, mineral oil, orlistat) can decrease||
7038|057|H|the absorption of vitamin D. Separate your doses of these||
7038|058|H|medications as far as possible from your doses of calcitriol (at||
7038|059|H|least 2 hours apart, longer if possible). It may be easiest to||
7038|060|H|take calcitriol at bedtime if you are also taking these other||
7038|061|H|medications. Ask your doctor or pharmacist about finding a good||
7038|062|H|dosing schedule that will work with all your medications.||
7038|063|B|||
7038|064|S|SIDE EFFECTS:  Calcitriol does not usually have side effects.||
7038|065|S|Your doctor may check your calcium and phosphate blood levels and||
7038|066|S|adjust your dose if you have side effects.||
7038|067|S|   Remember that this medication has been prescribed because your||
7038|068|S|doctor has judged that the benefit to you is greater than the||
7038|069|S|risk of side effects. Many people using this medication do not||
7038|070|S|have serious side effects.||
7038|071|S|   Tell your doctor right away if you have any serious side||
7038|072|S|effects, including: loss of appetite, back/bone/joint/muscle||
7038|073|S|pain, constipation, dry mouth, eye pain/redness/sensitivity to||
7038|074|S|light, headache, fast/slow/irregular heartbeat,||
7038|075|S|nausea/vomiting/diarrhea, sleepiness, stomach/abdominal pain,||
7038|076|S|increased thirst, signs of kidney problems (such as change in the||
7038|077|S|amount of urine), weakness.||
7038|078|S|   A very serious allergic reaction to this drug is rare.||
7038|079|S|However, get medical help right away if you notice any symptoms||
7038|080|S|of a serious allergic reaction, including: rash, itching/swelling||
7038|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7038|082|S|breathing.||
7038|083|S|   This is not a complete list of possible side effects. If you||
7038|084|S|notice other effects not listed above, contact your doctor or||
7038|085|S|pharmacist.||
7038|086|S|   In the US -||
7038|087|S|   Call your doctor for medical advice about side effects. You||
7038|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7038|089|S|www.fda.gov/medwatch.||
7038|090|S|   In Canada - Call your doctor for medical advice about side||
7038|091|S|effects. You may report side effects to Health Canada at||
7038|092|S|1-866-234-2345.||
7038|093|B|||
7038|094|P|PRECAUTIONS:  Before taking calcitriol, tell your doctor or||
7038|095|P|pharmacist if you are allergic to it; or to other vitamin D||
7038|096|P|products; or if you have any other allergies. This product may||
7038|097|P|contain inactive ingredients, which can cause allergic reactions||
7038|098|P|or other problems. Talk to your pharmacist for more details.||
7038|099|P|   Before using this medication, tell your doctor or pharmacist||
7038|100|P|your medical history, especially of: high calcium levels, heart||
7038|101|P|disease (such as irregular heartbeat, coronary artery disease),||
7038|102|P|kidney disease (such as kidney stones).||
7038|103|P|   Notify your doctor beforehand if you will be having surgery or||
7038|104|P|will be confined to a chair/bed (immobile) for a long time. Being||
7038|105|P|immobile for long periods of time increases your risk of side||
7038|106|P|effects.||
7038|107|P|   Be sure to drink plenty of fluids unless otherwise directed by||
7038|108|P|your doctor.||
7038|109|P|   During pregnancy, this medication should be used only when||
7038|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
7038|111|P|   It is unknown if this drug passes into breast milk. Consult||
7038|112|P|your doctor before breastfeeding.||
7038|113|B|||
7038|114|I|DRUG INTERACTIONS:  See also How to Use section.||
7038|115|I|   Drug interactions may change how your medications work or||
7038|116|I|increase your risk for serious side effects. This document does||
7038|117|I|not contain all possible drug interactions. Keep a list of all||
7038|118|I|the products you use (including prescription/nonprescription||
7038|119|I|drugs and herbal products) and share it with your doctor and||
7038|120|I|pharmacist. Do not start, stop, or change the dosage of any||
7038|121|I|medicines without your doctor's approval.||
7038|122|I|   Some products that may interact with this drug include:||
7038|123|I|burosumab, cardiac glycosides (such as digoxin, digitalis),||
7038|124|I|magnesium-containing medications (such as antacids, milk of||
7038|125|I|magnesia), phosphate binders, vitamins/nutritional supplements||
7038|126|I|(especially calcium and vitamin D), drugs that can speed up the||
7038|127|I|removal of calcitriol from your body (such as ketoconazole,||
7038|128|I|phenobarbital, phenytoin).||
7038|129|I|   Check the labels on all your prescription and||
7038|130|I|nonprescription/herbal products (such as antacids, laxatives,||
7038|131|I|vitamins) because they may contain calcium, magnesium, phosphate,||
7038|132|I|and vitamin D. Ask your pharmacist about using those products||
7038|133|I|safely.||
7038|134|I|   Calcitriol is very similar to other forms of vitamin D. Do not||
7038|135|I|use medications containing other forms of vitamin D while using||
7038|136|I|calcitriol.||
7038|137|I|   This medication may interfere with certain lab tests (such as||
7038|138|I|cholesterol test), possibly causing false test results. Make sure||
7038|139|I|lab personnel and all your doctors know you use this drug.||
7038|140|B|||
7038|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7038|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7038|143|O|poison control center right away. US residents can call||
7038|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7038|145|O|Symptoms of overdose may include: weakness, headache, loss of||
7038|146|O|appetite, metallic taste, nausea, vomiting, stomach cramps,||
7038|147|O|dizziness.||
7038|148|B|||
7038|149|N|NOTES:  Do not share this medication with others.||
7038|150|N|   Lab and/or medical tests (such as calcium, magnesium,||
7038|151|N|phosphorus, parathyroid levels) should be done while you are||
7038|152|N|taking this medication. Keep all medical and lab appointments.||
7038|153|N|Consult your doctor for more details.||
7038|154|N|   Foods rich in vitamin D include: fortified dairy products,||
7038|155|N|eggs, sardines, cod liver oil, chicken livers and freshwater||
7038|156|N|fish. Vitamin D is also obtained from periodic exposure to the||
7038|157|N|sun.||
7038|158|N|   It is important to maintain a well-balanced diet while taking||
7038|159|N|this medication. Calcium supplements may be recommended in||
7038|160|N|addition to this medication. The usual recommendation for calcium||
7038|161|N|is 600 to 1200 milligrams per day. Discuss this with your doctor.||
7038|162|N|Do not take supplements unless directed by your doctor.||
7038|163|B|||
7038|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7038|165|D|remember. If it is near the time of the next dose, skip the||
7038|166|D|missed dose. Take your next dose at the regular time. Do not||
7038|167|D|double the dose to catch up.||
7038|168|B|||
7038|169|R|STORAGE:  Store at room temperature away from light and moisture.||
7038|170|R|Do not store in the bathroom. Keep all medications away from||
7038|171|R|children and pets.||
7038|172|R|   Do not flush medications down the toilet or pour them into a||
7038|173|R|drain unless instructed to do so. Properly discard this product||
7038|174|R|when it is expired or no longer needed. Consult your pharmacist||
7038|175|R|or local waste disposal company.||
7038|176|B|||
7038|177|A|Information last revised June 2024.||
7038|178|A|Copyright(c) 2025 First Databank, Inc.||
7038|179|B|||
7039|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7039|002|Z|does NOT have all possible information about this product. This||
7039|003|Z|information does not assure that this product is safe, effective,||
7039|004|Z|or appropriate for you. This information is not individual||
7039|005|Z|medical advice and does not substitute for the advice of your||
7039|006|Z|health care professional. Always ask your health care||
7039|007|Z|professional for complete information about this product and your||
7039|008|Z|specific health needs.||
7039|009|B|||
7039|010|T|AZELAIC ACID CREAM - TOPICAL||
7039|011|F|(ay-ze-LAY-ik AS-id)||
7039|012|B|||
7039|013|C|COMMON BRAND NAME(S): Azelex||
7039|014|B|||
7039|015|U|USES:  This medication is used to treat mild to moderate acne. It||
7039|016|U|works by reducing the amount of acne-causing bacteria on the skin||
7039|017|U|and by helping to keep your pores open and unblocked, thus||
7039|018|U|decreasing the number of acne pimples. Azelaic acid belongs to a||
7039|019|U|class of drugs known as dicarboxylic acids.||
7039|020|B|||
7039|021|H|HOW TO USE:  Before using this medication, clean the affected||
7039|022|H|area and pat dry. Apply this medication to the skin as directed||
7039|023|H|by your doctor, usually twice daily (in the morning and evening).||
7039|024|H|Apply a thin layer and massage gently into the affected areas.||
7039|025|H|Wash your hands after use.||
7039|026|H|   Use this medication regularly in order to get the most benefit||
7039|027|H|from it. To help you remember, use it at the same times each day.||
7039|028|H|   Avoid contact in or near the eyes or inside the nose and||
7039|029|H|mouth. If this medication gets into any of these areas, wash||
7039|030|H|right away with plenty of water and call your doctor if||
7039|031|H|irritation lasts. Do not place a bandage or cover over the cream||
7039|032|H|unless your doctor tells you to do so.||
7039|033|H|   Do not use large amounts of this medication or apply it more||
7039|034|H|often than directed. Your condition will not improve any faster,||
7039|035|H|and the risk of side effects may increase. Use this medication||
7039|036|H|for the full course of treatment as directed by your doctor. It||
7039|037|H|usually takes about 1 month to see an improvement, but the full||
7039|038|H|effects of treatment may take longer.||
7039|039|H|   Tell your doctor if your condition does not get better after 1||
7039|040|H|month or if it gets worse.||
7039|041|B|||
7039|042|S|SIDE EFFECTS:  Temporary stinging, burning, itching, or tingling||
7039|043|S|of the skin may occur, usually at the beginning of treatment.||
7039|044|S|These effects usually lessen as your body adjusts to this||
7039|045|S|medication. However, if minor irritation continues, your doctor||
7039|046|S|may instruct you to only use this product once daily. If any of||
7039|047|S|these effects last or get worse, stop using this medication and||
7039|048|S|tell your doctor or pharmacist promptly.||
7039|049|S|   Remember that this medication has been prescribed because your||
7039|050|S|doctor has judged that the benefit to you is greater than the||
7039|051|S|risk of side effects. Many people using this medication do not||
7039|052|S|have serious side effects.||
7039|053|S|   Rarely, some people may experience lightening of skin color||
7039|054|S|(hypopigmentation) after using this medication. This side effect||
7039|055|S|may be more noticeable in people with dark skin color. Consult||
7039|056|S|your doctor for more details and report any skin color changes.||
7039|057|S|   A very serious allergic reaction to this drug is rare.||
7039|058|S|However, get medical help right away if you notice any symptoms||
7039|059|S|of a serious allergic reaction, including: rash, itching/swelling||
7039|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7039|061|S|breathing.||
7039|062|S|   This is not a complete list of possible side effects. If you||
7039|063|S|notice other effects not listed above, contact your doctor or||
7039|064|S|pharmacist.||
7039|065|S|   In the US -||
7039|066|S|   Call your doctor for medical advice about side effects. You||
7039|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7039|068|S|www.fda.gov/medwatch.||
7039|069|S|   In Canada - Call your doctor for medical advice about side||
7039|070|S|effects. You may report side effects to Health Canada at||
7039|071|S|1-866-234-2345.||
7039|072|B|||
7039|073|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
7039|074|P|pharmacist if you are allergic to it; or if you have any other||
7039|075|P|allergies. This product may contain inactive ingredients, which||
7039|076|P|can cause allergic reactions or other problems. Talk to your||
7039|077|P|pharmacist for more details.||
7039|078|P|   Before using this medication, tell your doctor or pharmacist||
7039|079|P|your medical history.||
7039|080|P|   Before having surgery, tell your doctor or dentist about all||
7039|081|P|the products you use (including prescription drugs,||
7039|082|P|nonprescription drugs, and herbal products).||
7039|083|P|   During pregnancy, this medication should be used only when||
7039|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
7039|085|P|   This medication may pass into breast milk. Consult your doctor||
7039|086|P|before breastfeeding.||
7039|087|B|||
7039|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7039|089|I|medications work or increase your risk for serious side effects.||
7039|090|I|This document does not contain all possible drug interactions.||
7039|091|I|Keep a list of all the products you use (including||
7039|092|I|prescription/nonprescription drugs and herbal products) and share||
7039|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
7039|094|I|the dosage of any medicines without your doctor's approval.||
7039|095|B|||
7039|096|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7039|097|O|has overdosed and has serious symptoms such as passing out or||
7039|098|O|trouble breathing, call 911. Otherwise, call a poison control||
7039|099|O|center right away. US residents can call 1-800-222-1222. Canada||
7039|100|O|residents can call 1-844-764-7669.||
7039|101|B|||
7039|102|N|NOTES:  Do not share this medication with others.||
7039|103|B|||
7039|104|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
7039|105|D|remember. If it is near the time of the next dose, skip the||
7039|106|D|missed dose. Use your next dose at the regular time. Do not||
7039|107|D|double the dose to catch up.||
7039|108|B|||
7039|109|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
7039|110|R|medications away from children and pets.||
7039|111|R|   Do not flush medications down the toilet or pour them into a||
7039|112|R|drain unless instructed to do so. Properly discard this product||
7039|113|R|when it is expired or no longer needed. Consult your pharmacist||
7039|114|R|or local waste disposal company.||
7039|115|B|||
7039|116|A|Information last revised November 2024.||
7039|117|A|Copyright(c) 2025 First Databank, Inc.||
7039|118|B|||
7043|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7043|002|Z|does NOT have all possible information about this product. This||
7043|003|Z|information does not assure that this product is safe, effective,||
7043|004|Z|or appropriate for you. This information is not individual||
7043|005|Z|medical advice and does not substitute for the advice of your||
7043|006|Z|health care professional. Always ask your health care||
7043|007|Z|professional for complete information about this product and your||
7043|008|Z|specific health needs.||
7043|009|B|||
7043|010|T|FUROSEMIDE - INJECTION||
7043|011|F|(fure-OH-se-mide)||
7043|012|B|||
7043|013|C|COMMON BRAND NAME(S): Lasix||
7043|014|B|||
7043|015|U|USES:  This medication is known as a diuretic (like a "water||
7043|016|U|pill"). It helps your body get rid of extra water by increasing||
7043|017|U|the amount of urine you make. Getting rid of extra water||
7043|018|U|decreases the strain on your heart and blood vessels, thereby||
7043|019|U|lowering high blood pressure and reducing your risk of strokes,||
7043|020|U|heart attacks, and kidney problems. This effect can also improve||
7043|021|U|symptoms such as trouble breathing and swelling (edema). This||
7043|022|U|injectable form of furosemide is used when the drug cannot be||
7043|023|U|taken by mouth, especially in patients with severe medical||
7043|024|U|conditions.||
7043|025|B|||
7043|026|H|HOW TO USE:  This medication is given by injection into a muscle||
7043|027|H|or slowly into a vein as directed by your doctor. The dosage is||
7043|028|H|based on your age, medical condition, and response to treatment.||
7043|029|H|Children's dosage is also based on weight.||
7043|030|H|   If you are giving this medication to yourself at home, learn||
7043|031|H|all preparation and usage instructions from your health care||
7043|032|H|professional. Before using, check this product for particles or||
7043|033|H|discoloration. If either is present, do not use the liquid. Learn||
7043|034|H|how to store and discard medical supplies safely.||
7043|035|H|   Tell your doctor if your condition lasts or gets worse.||
7043|036|B|||
7043|037|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, blurred||
7043|038|S|vision, loss of appetite, stomach upset, diarrhea, or||
7043|039|S|constipation may occur. If any of these effects last or get||
7043|040|S|worse, tell your doctor or pharmacist promptly.||
7043|041|S|   To reduce the risk of dizziness and lightheadedness, get up||
7043|042|S|slowly when rising from a sitting or lying position.||
7043|043|S|   Remember that this medication has been prescribed because your||
7043|044|S|doctor has judged that the benefit to you is greater than the||
7043|045|S|risk of side effects. Many people using this medication do not||
7043|046|S|have serious side effects.||
7043|047|S|   This medication may cause dehydration and electrolyte||
7043|048|S|imbalance. Tell your doctor right away if you have any symptoms||
7043|049|S|of dehydration or electrolyte imbalance, including unusual dry||
7043|050|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
7043|051|S|heartbeat, or confusion.||
7043|052|S|   Tell your doctor right away if you have any serious side||
7043|053|S|effects, including: signs of kidney problems (such as change in||
7043|054|S|the amount of urine), fainting, hearing loss, ringing in the||
7043|055|S|ears, numbness/tingling of the arms/legs, signs of liver problems||
7043|056|S|(such as stomach/abdominal pain, yellowing eyes/skin).||
7043|057|S|   A very serious allergic reaction to this drug is rare.||
7043|058|S|However, get medical help right away if you notice any symptoms||
7043|059|S|of a serious allergic reaction, including: rash, itching/swelling||
7043|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7043|061|S|breathing.||
7043|062|S|   This is not a complete list of possible side effects. If you||
7043|063|S|notice other effects not listed above, contact your doctor or||
7043|064|S|pharmacist.||
7043|065|S|   In the US -||
7043|066|S|   Call your doctor for medical advice about side effects. You||
7043|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7043|068|S|www.fda.gov/medwatch.||
7043|069|S|   In Canada - Call your doctor for medical advice about side||
7043|070|S|effects. You may report side effects to Health Canada at||
7043|071|S|1-866-234-2345.||
7043|072|B|||
7043|073|P|PRECAUTIONS:  Before using furosemide, tell your doctor or||
7043|074|P|pharmacist if you are allergic to it; or if you have any other||
7043|075|P|allergies. This product may contain inactive ingredients, which||
7043|076|P|can cause allergic reactions or other problems. Talk to your||
7043|077|P|pharmacist for more details.||
7043|078|P|   Before using this medication, tell your doctor or pharmacist||
7043|079|P|your medical history, especially of: kidney disease, liver||
7043|080|P|disease, gout, lupus.||
7043|081|P|   If you have diabetes, furosemide may make it harder to control||
7043|082|P|your blood sugar. Check your blood sugar regularly as directed||
7043|083|P|and share the results with your doctor.||
7043|084|P|   This drug may reduce the potassium levels in your blood. Ask||
7043|085|P|your doctor about adding potassium to your diet. A potassium||
7043|086|P|supplement may be prescribed by your doctor.||
7043|087|P|   This medication may make you more sensitive to the sun. Limit||
7043|088|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
7043|089|P|sunscreen and wear protective clothing when outdoors. Tell your||
7043|090|P|doctor right away if you get sunburned or have skin||
7043|091|P|blisters/redness.||
7043|092|P|   Before having surgery, tell your doctor or dentist about all||
7043|093|P|the products you use (including prescription drugs,||
7043|094|P|nonprescription drugs, and herbal products).||
7043|095|P|   This drug may make you dizzy or drowsy or blur your vision.||
7043|096|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7043|097|P|drowsy. Do not drive, use machinery, or do anything that needs||
7043|098|P|alertness or clear vision until you can do it safely. Limit||
7043|099|P|alcoholic beverages. Talk to your doctor if you are using||
7043|100|P|marijuana (cannabis).||
7043|101|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
7043|102|P|and cause you to feel lightheaded. Tell your doctor if you have||
7043|103|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
7043|104|P|of fluids unless your doctor tells you not to.||
7043|105|P|   Babies born early (premature infants) and children may be more||
7043|106|P|sensitive to certain effects of this drug, such as kidney stones.||
7043|107|P|   Older adults may be more sensitive to the side effects of this||
7043|108|P|drug, especially dizziness and water/mineral loss.||
7043|109|P|   During pregnancy, furosemide should be used only when clearly||
7043|110|P|needed. Discuss the risks and benefits with your doctor.||
7043|111|P|   This drug passes into breast milk. Consult your doctor before||
7043|112|P|breastfeeding.||
7043|113|B|||
7043|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7043|115|I|medications work or increase your risk for serious side effects.||
7043|116|I|This document does not contain all possible drug interactions.||
7043|117|I|Keep a list of all the products you use (including||
7043|118|I|prescription/nonprescription drugs and herbal products) and share||
7043|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
7043|120|I|the dosage of any medicines without your doctor's approval.||
7043|121|I|   Some products that may interact with this drug include:||
7043|122|I|desmopressin, ethacrynic acid, lithium.||
7043|123|I|   Some products have ingredients that could raise your blood||
7043|124|I|pressure or worsen your swelling. Tell your pharmacist what||
7043|125|I|products you are using, and ask how to use them safely||
7043|126|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
7043|127|I|ibuprofen/naproxen).||
7043|128|I|   This medication may interfere with certain lab tests (such as||
7043|129|I|thyroid hormone levels), possibly causing false test results.||
7043|130|I|Make sure lab personnel and all your doctors know you use this||
7043|131|I|drug.||
7043|132|B|||
7043|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7043|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7043|135|O|poison control center right away. US residents can call||
7043|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7043|137|O|Symptoms of overdose may include: a severe decrease in amount of||
7043|138|O|urine, weakness, fast/irregular heartbeat.||
7043|139|B|||
7043|140|N|NOTES:  Do not share this medication with others.||
7043|141|N|   Lab and/or medical tests (such as kidney function, blood||
7043|142|N|mineral levels such as sodium/potassium) should be done while you||
7043|143|N|are using this medication. Consult your doctor for more details.||
7043|144|B|||
7043|145|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7043|146|D|If it is near the time of the next dose, skip the missed dose.||
7043|147|D|Use your next dose at the regular time. Do not double the dose to||
7043|148|D|catch up.||
7043|149|B|||
7043|150|R|STORAGE:  Consult the product instructions and your pharmacist||
7043|151|R|for storage details. Keep all medications away from children and||
7043|152|R|pets.||
7043|153|R|   Do not flush medications down the toilet or pour them into a||
7043|154|R|drain unless instructed to do so. Properly discard this product||
7043|155|R|when it is expired or no longer needed. Consult your pharmacist||
7043|156|R|or local waste disposal company.||
7043|157|B|||
7043|158|A|Information last revised November 2024.||
7043|159|A|Copyright(c) 2025 First Databank, Inc.||
7043|160|B|||
7046|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7046|002|Z|does NOT have all possible information about this product. This||
7046|003|Z|information does not assure that this product is safe, effective,||
7046|004|Z|or appropriate for you. This information is not individual||
7046|005|Z|medical advice and does not substitute for the advice of your||
7046|006|Z|health care professional. Always ask your health care||
7046|007|Z|professional for complete information about this product and your||
7046|008|Z|specific health needs.||
7046|009|B|||
7046|010|T|MERCAPTOPURINE - ORAL||
7046|011|F|(mer-KAP-toe-PURE-een)||
7046|012|B|||
7046|013|C|COMMON BRAND NAME(S): Purinethol, Purixan||
7046|014|B|||
7046|015|U|USES:  This medication is used to treat a certain type of cancer||
7046|016|U|(acute lymphocytic leukemia). It is a chemotherapy drug that||
7046|017|U|works by slowing or stopping the growth of cancer cells.||
7046|018|U|   Talk to the doctor about the risks and benefits of||
7046|019|U|mercaptopurine, especially when used by children and young||
7046|020|U|adults.||
7046|021|B|||
7046|022|V|OTHER USES:  This section contains uses of this drug that are not||
7046|023|V|listed in the approved professional labeling for the drug but||
7046|024|V|that may be prescribed by your health care professional. Use this||
7046|025|V|drug for a condition that is listed in this section only if it||
7046|026|V|has been so prescribed by your health care professional.||
7046|027|V|   This drug may also be used for other types of leukemia or||
7046|028|V|certain types of bowel conditions (Crohn's disease, ulcerative||
7046|029|V|colitis).||
7046|030|B|||
7046|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7046|032|H|from your pharmacist before you start taking mercaptopurine and||
7046|033|H|each time you get a refill. If you have any questions, ask your||
7046|034|H|doctor or pharmacist.||
7046|035|H|   Take this medication by mouth with or without food as directed||
7046|036|H|by your doctor, usually once daily. Drink plenty of fluids while||
7046|037|H|taking this medication unless otherwise directed by your doctor.||
7046|038|H|Doing so may help decrease the risk of certain side effects||
7046|039|H|(kidney problems).||
7046|040|H|   If you are using the suspension, shake the bottle well for at||
7046|041|H|least 30 seconds before each dose. Carefully measure the dose||
7046|042|H|using the provided special measuring device. Do not use a||
7046|043|H|household spoon because you may not get the correct dose. Avoid||
7046|044|H|getting any of the suspension on your skin or in your eyes. If||
7046|045|H|contact occurs, wash the affected skin area or rinse your eyes||
7046|046|H|with water. Consult your pharmacist for details.||
7046|047|H|   The dosage is based on your medical condition, weight, and||
7046|048|H|response to treatment. Do not increase your dose or use this drug||
7046|049|H|more often or for longer than prescribed. Your condition will not||
7046|050|H|improve any faster, and your risk of serious side effects will||
7046|051|H|increase.||
7046|052|H|   Use this medication regularly to get the most benefit from it.||
7046|053|H|To help you remember, take it at the same time each day.||
7046|054|H|   Since this drug can be absorbed through the skin and lungs and||
7046|055|H|may harm an unborn baby, women who are pregnant or who may become||
7046|056|H|pregnant should not handle this medication or breathe the dust||
7046|057|H|from the tablets.||
7046|058|B|||
7046|059|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, and loss of appetite||
7046|060|S|may occur. Temporary hair loss may also occur. If any of these||
7046|061|S|effects last or get worse, tell your doctor or pharmacist||
7046|062|S|promptly.||
7046|063|S|   People using this medication may have serious side effects.||
7046|064|S|However, you have been prescribed this drug because your doctor||
7046|065|S|has judged that the benefit to you is greater than the risk of||
7046|066|S|side effects. Careful monitoring by your doctor may decrease your||
7046|067|S|risk.||
7046|068|S|   Tell your doctor right away if you have any serious side||
7046|069|S|effects, including: joint pain/swelling, black stools, vomit that||
7046|070|S|looks like coffee grounds, signs of kidney problems (such as||
7046|071|S|change in the amount of urine, pain in the lower back/side).||
7046|072|S|   Get medical help right away if you have any very serious side||
7046|073|S|effects, including: symptoms of liver disease (such as||
7046|074|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
7046|075|S|yellowing eyes/skin, dark urine).||
7046|076|S|   This medication may decrease bone marrow function, an effect||
7046|077|S|that may lead to a low number of blood cells such as red cells,||
7046|078|S|white cells, and platelets. This effect can cause anemia,||
7046|079|S|decrease your body's ability to fight an infection, or cause easy||
7046|080|S|bruising/bleeding. Tell your doctor right away if you develop any||
7046|081|S|of the following symptoms: unusual tiredness, pale skin, signs of||
7046|082|S|infection (such as sore throat that doesn't go away, fever,||
7046|083|S|chills), easy bruising/bleeding.||
7046|084|S|   Mercaptopurine may rarely increase your risk of developing||
7046|085|S|certain types of cancer (such as lymphoma, skin, cervical). This||
7046|086|S|risk is higher in children/young adults being treated for certain||
7046|087|S|bowel diseases (such as Crohn's disease, ulcerative colitis).||
7046|088|S|Tell your doctor right away if you develop any of the following||
7046|089|S|symptoms: swollen abdomen, swollen lymph nodes, night sweats,||
7046|090|S|unexplained weight loss, unusual skin changes (such as new skin||
7046|091|S|lesion or bump, or change in size or color of a mole), unusual||
7046|092|S|vaginal bleeding/discharge.||
7046|093|S|   A very serious allergic reaction to this drug is rare.||
7046|094|S|However, get medical help right away if you notice any symptoms||
7046|095|S|of a serious allergic reaction, including: rash, itching/swelling||
7046|096|S|(especially of the face/tongue/throat), dizziness, trouble||
7046|097|S|breathing.||
7046|098|S|   This is not a complete list of possible side effects. If you||
7046|099|S|notice other effects not listed above, contact your doctor or||
7046|100|S|pharmacist.||
7046|101|S|   In the US -||
7046|102|S|   Call your doctor for medical advice about side effects. You||
7046|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7046|104|S|www.fda.gov/medwatch.||
7046|105|S|   In Canada - Call your doctor for medical advice about side||
7046|106|S|effects. You may report side effects to Health Canada at||
7046|107|S|1-866-234-2345.||
7046|108|B|||
7046|109|P|PRECAUTIONS:  Before taking mercaptopurine, tell your doctor or||
7046|110|P|pharmacist if you are allergic to it; or to azathioprine; or if||
7046|111|P|you have any other allergies. This product may contain inactive||
7046|112|P|ingredients, which can cause allergic reactions or other||
7046|113|P|problems. Talk to your pharmacist for more details.||
7046|114|P|   Before using this medication, tell your doctor or pharmacist||
7046|115|P|your medical history, especially of: kidney disease, liver||
7046|116|P|disease, cancer, certain enzyme disorders (TPMT deficiency,||
7046|117|P|NUDT15 deficiency).||
7046|118|P|   Mercaptopurine can make you more likely to get infections or||
7046|119|P|may make current infections worse. Stay away from anyone who has||
7046|120|P|an infection that may easily spread (such as chickenpox,||
7046|121|P|COVID-19, measles, flu). Talk to your doctor if you have been||
7046|122|P|exposed to an infection or for more details.||
7046|123|P|   Tell your health care professional that you are using||
7046|124|P|mercaptopurine before having any immunizations/vaccinations.||
7046|125|P|Avoid contact with people who have recently received live||
7046|126|P|vaccines (such as flu vaccine inhaled through the nose).||
7046|127|P|   To lower the chance of getting cut, bruised, or injured, use||
7046|128|P|caution with sharp objects like razors and nail cutters, and||
7046|129|P|avoid activities such as contact sports.||
7046|130|P|   This medication may make you more sensitive to the sun. Limit||
7046|131|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
7046|132|P|sunscreen and wear protective clothing when outdoors. Tell your||
7046|133|P|doctor right away if you get sunburned or have skin||
7046|134|P|blisters/redness.||
7046|135|P|   Before having surgery, tell your doctor or dentist about all||
7046|136|P|the products you use (including prescription drugs,||
7046|137|P|nonprescription drugs, and herbal products).||
7046|138|P|   Since this drug can be absorbed through the skin and lungs and||
7046|139|P|may harm an unborn baby, women who are pregnant or who may become||
7046|140|P|pregnant should not handle this medication or breathe the dust||
7046|141|P|from the tablets.||
7046|142|P|   Tell your doctor if you are pregnant or plan to become||
7046|143|P|pregnant. You should not become pregnant while using||
7046|144|P|mercaptopurine. Mercaptopurine may harm an unborn baby,||
7046|145|P|especially during the first 3 months of pregnancy. Your doctor||
7046|146|P|should order a pregnancy test before you start this medication.||
7046|147|P|Women using this medication should ask about reliable forms of||
7046|148|P|birth control during treatment and for 6 months after the last||
7046|149|P|dose. Men using this medication should ask about reliable forms||
7046|150|P|of birth control during treatment and for 3 months after the last||
7046|151|P|dose. If you or your partner becomes pregnant, talk to your||
7046|152|P|doctor right away about the risks and benefits of this||
7046|153|P|medication.||
7046|154|P|   It is unknown if this drug passes into breast milk. Because of||
7046|155|P|the possible risk to the infant, breastfeeding is not recommended||
7046|156|P|while using this drug and for 1 week after the last dose. Consult||
7046|157|P|your doctor before breastfeeding.||
7046|158|B|||
7046|159|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7046|160|I|medications work or increase your risk for serious side effects.||
7046|161|I|This document does not contain all possible drug interactions.||
7046|162|I|Keep a list of all the products you use (including||
7046|163|I|prescription/nonprescription drugs and herbal products) and share||
7046|164|I|it with your doctor and pharmacist. Do not start, stop, or change||
7046|165|I|the dosage of any medicines without your doctor's approval.||
7046|166|I|   Some products that may interact with this drug are:||
7046|167|I|febuxostat, other drugs that weaken the immune system/increase||
7046|168|I|the risk of infection (such as rituximab, tofacitinib).||
7046|169|I|   This medication may interfere with certain lab tests (such as||
7046|170|I|uric acid levels), possibly causing false test results. Make sure||
7046|171|I|lab personnel and all your doctors know you use this drug.||
7046|172|I|   Mercaptopurine is very similar to azathioprine. Do not use||
7046|173|I|medications containing azathioprine while using mercaptopurine.||
7046|174|B|||
7046|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7046|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7046|177|O|poison control center right away. US residents can call||
7046|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7046|179|B|||
7046|180|N|NOTES:  Do not share this medication with others.||
7046|181|N|   Lab and/or medical tests (such as complete blood count,||
7046|182|N|liver/kidney function) should be done while you are taking this||
7046|183|N|medication. Keep all medical and lab appointments. Consult your||
7046|184|N|doctor for more details.||
7046|185|B|||
7046|186|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7046|187|D|remember. If it is near the time of the next dose, skip the||
7046|188|D|missed dose. Take your next dose at the regular time. Do not||
7046|189|D|double the dose to catch up.||
7046|190|B|||
7046|191|R|STORAGE:  Store at room temperature away from light and moisture.||
7046|192|R|Do not store in the bathroom. For the suspension form, once the||
7046|193|R|bottle is opened, the medication expires after 8 weeks. Keep all||
7046|194|R|medications away from children and pets.||
7046|195|R|   Do not flush medications down the toilet or pour them into a||
7046|196|R|drain unless instructed to do so. Properly discard this product||
7046|197|R|when it is expired or no longer needed. Consult your pharmacist||
7046|198|R|or local waste disposal company.||
7046|199|B|||
7046|200|M|MEDICAL ALERT:  Your condition can cause complications in a||
7046|201|M|medical emergency. For information about enrolling in MedicAlert,||
7046|202|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7046|203|B|||
7046|204|A|Information last revised September 2024.||
7046|205|A|Copyright(c) 2025 First Databank, Inc.||
7046|206|B|||
7047|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7047|002|Z|does NOT have all possible information about this product. This||
7047|003|Z|information does not assure that this product is safe, effective,||
7047|004|Z|or appropriate for you. This information is not individual||
7047|005|Z|medical advice and does not substitute for the advice of your||
7047|006|Z|health care professional. Always ask your health care||
7047|007|Z|professional for complete information about this product and your||
7047|008|Z|specific health needs.||
7047|009|B|||
7047|010|T|AMITRIPTYLINE/CHLORDIAZEPOXIDE - ORAL||
7047|011|F|(AM-i-TRIP-ti-leen/KLOR-dye-AZ-e-POX-ide)||
7047|012|B|||
7047|013|C|COMMON BRAND NAME(S): Limbitrol||
7047|014|B|||
7047|015|W|WARNING:  Antidepressant medications are used to treat a variety||
7047|016|W|of conditions, including depression and other mental/mood||
7047|017|W|disorders. These medications can help prevent suicidal||
7047|018|W|thoughts/attempts and provide other important benefits. However,||
7047|019|W|studies have shown that a small number of people (especially||
7047|020|W|people younger than 25) who take antidepressants for any||
7047|021|W|condition may experience worsening depression, other mental/mood||
7047|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
7047|023|W|talk with the doctor about the risks and benefits of||
7047|024|W|antidepressant medication (especially for people younger than||
7047|025|W|25), even if treatment is not for a mental/mood condition.||
7047|026|W|   Tell the doctor right away if you notice worsening||
7047|027|W|depression/other psychiatric conditions, unusual behavior changes||
7047|028|W|(including possible suicidal thoughts/attempts), or other||
7047|029|W|mental/mood changes (including new/worsening anxiety, panic||
7047|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
7047|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
7047|032|W|especially watchful for these symptoms when a new antidepressant||
7047|033|W|is started or when the dose is changed.||
7047|034|W|   Chlordiazepoxide has a risk for abuse and addiction, which can||
7047|035|W|lead to overdose and death. Taking this medication with alcohol||
7047|036|W|or other drugs that can cause drowsiness or breathing problems||
7047|037|W|(especially opioid medications such as codeine, hydrocodone) may||
7047|038|W|cause very serious side effects, including death. To lower your||
7047|039|W|risk, your doctor should have you take the smallest dose of||
7047|040|W|chlordiazepoxide that works, and take it for the shortest||
7047|041|W|possible time. Be sure you know how to take chlordiazepoxide and||
7047|042|W|what other drugs you should avoid taking with it. See also Drug||
7047|043|W|Interactions section. Get medical help right away if any of these||
7047|044|W|very serious side effects occur: slow/shallow breathing, unusual||
7047|045|W|lightheadedness, severe drowsiness/dizziness, difficulty waking||
7047|046|W|up.||
7047|047|W|   Suddenly stopping this medication may cause serious (possibly||
7047|048|W|fatal) withdrawal, especially if you have used it for a long time||
7047|049|W|or in high doses. To prevent withdrawal, your doctor may lower||
7047|050|W|your dose slowly. Tell your doctor or pharmacist right away if||
7047|051|W|you have any withdrawal symptoms such as headaches, trouble||
7047|052|W|sleeping, restlessness, hallucinations/confusion, depression,||
7047|053|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
7047|054|W|to months.||
7047|055|B|||
7047|056|U|USES:  This combination medication is used to treat depression||
7047|057|U|with symptoms of anxiety. Amitriptyline belongs to a class of||
7047|058|U|drugs known as tricyclic antidepressants. It works by helping to||
7047|059|U|restore the balance of certain natural substances in the brain.||
7047|060|U|Chlordiazepoxide belongs to a class of drugs known as||
7047|061|U|benzodiazepines. It acts on the brain and nerves to produce a||
7047|062|U|calming effect.||
7047|063|B|||
7047|064|H|HOW TO USE:  See also Warning section.||
7047|065|H|   Read the Medication Guide available from your pharmacist.||
7047|066|H|Consult your doctor or pharmacist if you have any questions.||
7047|067|H|   Take this medication by mouth as directed by your doctor,||
7047|068|H|usually 1 to 4 times daily. The larger portion of the total daily||
7047|069|H|dose may be taken at bedtime to help reduce daytime sleepiness.||
7047|070|H|The dosage is based on your medical condition, age, and response||
7047|071|H|to treatment.||
7047|072|H|   To reduce your risk of side effects (such as drowsiness, dry||
7047|073|H|mouth, dizziness), your doctor may direct you to start this||
7047|074|H|medication at a low dose and gradually increase your dose. Follow||
7047|075|H|your doctor's instructions carefully.||
7047|076|H|   Take this medication regularly in order to get the most||
7047|077|H|benefit from it. To help you remember, take it at the same||
7047|078|H|time(s) each day. Do not increase your dose or use this drug more||
7047|079|H|often or for longer than prescribed. Your condition will not||
7047|080|H|improve any faster, and your risk of side effects will increase.||
7047|081|H|   This medication may not work right away. You may feel some||
7047|082|H|benefit the first week. However, it may take up to 4 weeks before||
7047|083|H|you experience the full effect.||
7047|084|H|   Keep taking this medication even if you feel well. Do not||
7047|085|H|suddenly stop taking this medication without consulting your||
7047|086|H|doctor. Some conditions may become worse when the drug is||
7047|087|H|abruptly stopped. Your dose may need to be gradually decreased.||
7047|088|H|   When this medication is used for a long time, it may not work||
7047|089|H|as well. Your doctor may need to increase your dose or change||
7047|090|H|your medication. Talk with your doctor if this medication stops||
7047|091|H|working well.||
7047|092|H|   Though it helps many people, this medication may sometimes||
7047|093|H|cause addiction. This risk may be higher if you have a substance||
7047|094|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
7047|095|H|Take this medication exactly as prescribed to lower the risk of||
7047|096|H|addiction. Ask your doctor or pharmacist for more details.||
7047|097|H|   Tell your doctor if your condition lasts or gets worse (such||
7047|098|H|as nervousness or feelings of sadness get worse, or you have||
7047|099|H|thoughts of suicide).||
7047|100|B|||
7047|101|S|SIDE EFFECTS:  See also Warning section.||
7047|102|S|   Drowsiness, dizziness, dry mouth, blurred vision,||
7047|103|S|constipation, bloating, trouble urinating, and weight gain may||
7047|104|S|occur. If any of these effects last or get worse, tell your||
7047|105|S|doctor or pharmacist promptly.||
7047|106|S|   To reduce the risk of dizziness and fainting, get up slowly||
7047|107|S|when rising from a sitting or lying position.||
7047|108|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
7047|109|S|chips, chew (sugarless) gum, drink water, or use a saliva||
7047|110|S|substitute.||
7047|111|S|   To prevent constipation, eat dietary fiber, drink enough||
7047|112|S|water, and exercise. You may also need to take a laxative. Ask||
7047|113|S|your pharmacist which type of laxative is right for you.||
7047|114|S|   Remember that this medication has been prescribed because your||
7047|115|S|doctor has judged that the benefit to you is greater than the||
7047|116|S|risk of side effects. Many people using this medication do not||
7047|117|S|have serious side effects.||
7047|118|S|   Tell your doctor right away if you have any serious side||
7047|119|S|effects, including: heartburn that doesn't go away,||
7047|120|S|nausea/vomiting that doesn't stop, easy bleeding/bruising, loss||
7047|121|S|of balance, mental/mood changes (such as confusion, excitement,||
7047|122|S|memory problems, suicidal thoughts), shaking (tremor), decreased||
7047|123|S|sexual ability/desire, signs of infection (such as sore throat||
7047|124|S|that doesn't go away, fever, chills), severe stomach/abdominal||
7047|125|S|pain, dark urine, yellowing eyes/skin.||
7047|126|S|   Get medical help right away if you have any very serious side||
7047|127|S|effects, including: black stools, chest pain, severe dizziness,||
7047|128|S|fainting, fast/irregular heartbeat, seizures, trouble speaking,||
7047|129|S|weakness on one side of the body, eye pain/swelling/redness,||
7047|130|S|widened pupils, vision changes (such as seeing rainbows around||
7047|131|S|lights at night), vomit that looks like coffee grounds.||
7047|132|S|   This medication may increase serotonin and rarely cause a very||
7047|133|S|serious condition called serotonin syndrome/toxicity. The risk||
7047|134|S|increases if you are also taking other drugs that increase||
7047|135|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
7047|136|S|take (see Drug Interactions section). Get medical help right away||
7047|137|S|if you develop some of the following symptoms: fast heartbeat,||
7047|138|S|hallucinations, loss of coordination, severe dizziness, severe||
7047|139|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
7047|140|S|unusual agitation/restlessness.||
7047|141|S|   A very serious allergic reaction to this drug is rare.||
7047|142|S|However, get medical help right away if you notice any symptoms||
7047|143|S|of a serious allergic reaction, including: rash, itching/swelling||
7047|144|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7047|145|S|breathing.||
7047|146|S|   This is not a complete list of possible side effects. If you||
7047|147|S|notice other effects not listed above, contact your doctor or||
7047|148|S|pharmacist.||
7047|149|S|   In the US -||
7047|150|S|   Call your doctor for medical advice about side effects. You||
7047|151|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7047|152|S|www.fda.gov/medwatch.||
7047|153|S|   In Canada - Call your doctor for medical advice about side||
7047|154|S|effects. You may report side effects to Health Canada at||
7047|155|S|1-866-234-2345.||
7047|156|B|||
7047|157|P|PRECAUTIONS:  See also Warning section.||
7047|158|P|   Before taking this medication, tell your doctor or pharmacist||
7047|159|P|if you are allergic to it; or to other benzodiazepines (such as||
7047|160|P|diazepam, lorazepam, alprazolam), or to other tricyclic||
7047|161|P|antidepressants (such as nortriptyline), or if you have any other||
7047|162|P|allergies. This product may contain inactive ingredients, which||
7047|163|P|can cause allergic reactions or other problems. Talk to your||
7047|164|P|pharmacist for more details.||
7047|165|P|   Before using this medication, tell your doctor or pharmacist||
7047|166|P|your medical history, especially of: personal or family history||
7047|167|P|of glaucoma (angle-closure type), bleeding problems,||
7047|168|P|breathing/lung problems, diabetes, kidney problems, liver||
7047|169|P|problems, heart problems (such as chest pain, irregular||
7047|170|P|heartbeat, recent heart attack), problems urinating (such as due||
7047|171|P|to enlarged prostate), chronic constipation, overactive thyroid||
7047|172|P|(hyperthyroidism), personal or family history of a substance use||
7047|173|P|disorder (such as overuse of or addiction to drugs/alcohol),||
7047|174|P|personal or family history of mental/mood conditions (such as||
7047|175|P|bipolar disorder, psychosis), family history of suicide,||
7047|176|P|seizures, conditions that may increase your risk of seizures||
7047|177|P|(such as brain disease/injury/tumor, alcohol withdrawal).||
7047|178|P|   Amitriptyline/chlordiazepoxide may cause a condition that||
7047|179|P|affects the heart rhythm (QT prolongation). QT prolongation can||
7047|180|P|rarely cause serious (rarely fatal) fast/irregular heartbeat and||
7047|181|P|other symptoms (such as severe dizziness, fainting) that need||
7047|182|P|medical attention right away.||
7047|183|P|   The risk of QT prolongation may be increased if you have||
7047|184|P|certain medical conditions or are taking other drugs that may||
7047|185|P|cause QT prolongation. Before using||
7047|186|P|amitriptyline/chlordiazepoxide, tell your doctor or pharmacist of||
7047|187|P|all the drugs you take and if you have any of the following||
7047|188|P|conditions: certain heart problems (heart failure, slow||
7047|189|P|heartbeat, QT prolongation in the EKG), family history of certain||
7047|190|P|heart problems (QT prolongation in the EKG, sudden cardiac||
7047|191|P|death).||
7047|192|P|   Low levels of potassium or magnesium in the blood may also||
7047|193|P|increase your risk of QT prolongation. This risk may increase if||
7047|194|P|you use certain drugs (such as diuretics/"water pills") or if you||
7047|195|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7047|196|P|Talk to your doctor about using amitriptyline/chlordiazepoxide||
7047|197|P|safely.||
7047|198|P|   This drug may make you dizzy or drowsy or blur your vision.||
7047|199|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7047|200|P|drowsy. Do not drive, use machinery, or do anything that needs||
7047|201|P|alertness or clear vision until you can do it safely. Avoid||
7047|202|P|alcoholic beverages. Talk to your doctor if you are using||
7047|203|P|marijuana (cannabis).||
7047|204|P|   This medication may make you more sensitive to the sun. Limit||
7047|205|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
7047|206|P|sunscreen and wear protective clothing when outdoors. Tell your||
7047|207|P|doctor right away if you get sunburned or have skin||
7047|208|P|blisters/redness.||
7047|209|P|   If you have diabetes, this drug may make it harder to control||
7047|210|P|your blood sugar levels. Monitor your blood sugar levels||
7047|211|P|regularly and tell your doctor of the results. Your doctor may||
7047|212|P|need to adjust your diabetes medication, exercise program, or||
7047|213|P|diet.||
7047|214|P|   Before having surgery or imaging procedures (such as certain||
7047|215|P|X-rays, CT scans) requiring the use of contrast dye (such as||
7047|216|P|metrizamide), tell your doctor or dentist that you are using this||
7047|217|P|medication and about all the products you use (including||
7047|218|P|prescription drugs, nonprescription drugs, and herbal products).||
7047|219|P|   Older adults may be more sensitive to the side effects of this||
7047|220|P|product, especially bleeding, confusion, dizziness, drowsiness,||
7047|221|P|constipation, difficulty urinating, and QT prolongation (see||
7047|222|P|above). Your doctor may start the medication at a lower dose to||
7047|223|P|prevent side effects. Confusion, dizziness, drowsiness can||
7047|224|P|increase the risk of falling. Older adults may also be more||
7047|225|P|likely to develop low sodium in the blood, especially if they are||
7047|226|P|taking "water pills" (diuretics).||
7047|227|P|   Tell your doctor if you are pregnant or plan to become||
7047|228|P|pregnant. You should not become pregnant while using||
7047|229|P|amitriptyline/chlordiazepoxide. This medication may harm an||
7047|230|P|unborn baby. Newborn babies of mothers who use this medication||
7047|231|P|late in pregnancy may have symptoms such as slow/shallow||
7047|232|P|breathing, nonstop crying, shaking, or trouble feeding. If you||
7047|233|P|become pregnant, talk to your doctor right away about the risks||
7047|234|P|and benefits of this medication.||
7047|235|P|   This medication passes into breast milk and may have||
7047|236|P|undesirable effects on a nursing infant. Consult your doctor||
7047|237|P|before breastfeeding.||
7047|238|B|||
7047|239|I|DRUG INTERACTIONS:  See also Warning section.||
7047|240|I|   Drug interactions may change how your medications work or||
7047|241|I|increase your risk for serious side effects. This document does||
7047|242|I|not contain all possible drug interactions. Keep a list of all||
7047|243|I|the products you use (including prescription/nonprescription||
7047|244|I|drugs and herbal products) and share it with your doctor and||
7047|245|I|pharmacist. Do not start, stop, or change the dosage of any||
7047|246|I|medicines without your doctor's approval.||
7047|247|I|   Some products that may interact with this product are: other||
7047|248|I|drugs that can cause bleeding/bruising (including antiplatelet||
7047|249|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
7047|250|I|"blood thinners" such as dabigatran/warfarin), certain drugs for||
7047|251|I|high blood pressure (drugs that work in the brain such as||
7047|252|I|clonidine, guanabenz), clozapine, thyroid supplements.||
7047|253|I|   Taking MAO inhibitors with this medication may cause a serious||
7047|254|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
7047|255|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
7047|256|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
7047|257|I|selegiline, tranylcypromine) during treatment with this||
7047|258|I|medication. Most MAO inhibitors should also not be taken for two||
7047|259|I|weeks before and after treatment with this medication. Ask your||
7047|260|I|doctor when to start or stop taking this medication.||
7047|261|I|   The risk of serotonin syndrome/toxicity increases if you are||
7047|262|I|also taking other drugs that increase serotonin. Examples include||
7047|263|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
7047|264|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
7047|265|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
7047|266|I|serotonin syndrome/toxicity may be more likely when you start or||
7047|267|I|increase the dose of these drugs.||
7047|268|I|   Other medications can affect the removal of amitriptyline and||
7047|269|I|chlordiazepoxide from your body, thereby affecting how||
7047|270|I|amitriptyline/chlordiazepoxide works. These drugs include||
7047|271|I|cimetidine, disulfiram, drugs to treat irregular heart rate (such||
7047|272|I|as quinidine/propafenone/flecainide), among others.||
7047|273|I|   Many drugs besides amitriptyline may affect the heart rhythm||
7047|274|I|(QT prolongation in the EKG), including amiodarone, dofetilide,||
7047|275|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
7047|276|I|(such as erythromycin), among others. Before using||
7047|277|I|amitriptyline/chlordiazepoxide, report all medications you are||
7047|278|I|currently using to your doctor or pharmacist.||
7047|279|I|   Cigarette smoking decreases blood levels of chlordiazepoxide.||
7047|280|I|Tell your doctor if you smoke or if you have recently stopped||
7047|281|I|smoking.||
7047|282|I|   The risk of serious side effects (such as slow/shallow||
7047|283|I|breathing, severe drowsiness/dizziness) may be increased if this||
7047|284|I|medication is taken with other products that may also cause||
7047|285|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
7047|286|I|if you are taking other products such as opioid pain or cough||
7047|287|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7047|288|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
7047|289|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7047|290|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7047|291|I|diphenhydramine).||
7047|292|I|   Check the labels on all your medicines (such as allergy or||
7047|293|I|cough-and-cold products) because they may contain ingredients||
7047|294|I|that cause drowsiness. Ask your pharmacist about using those||
7047|295|I|products safely.||
7047|296|I|   Aspirin can increase the risk of bleeding when used with this||
7047|297|I|medication. However, if your doctor has told you to take low-dose||
7047|298|I|aspirin to prevent heart attack or stroke (usually 81-162||
7047|299|I|milligrams a day), you should keep taking the aspirin unless your||
7047|300|I|doctor tells you not to. Ask your doctor or pharmacist for more||
7047|301|I|details.||
7047|302|I|   Amitriptyline is very similar to nortriptyline. Do not use||
7047|303|I|medications containing nortriptyline while using amitriptyline.||
7047|304|B|||
7047|305|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7047|306|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7047|307|O|poison control center right away. US residents can call||
7047|308|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7047|309|O|Symptoms of overdose may include: slow/shallow breathing,||
7047|310|O|inability to wake up (coma).||
7047|311|B|||
7047|312|N|NOTES:  Do not share this medication with others.||
7047|313|N|   Lab and/or medical tests (such as complete blood count, liver||
7047|314|N|function) may be done while you are taking this medication. Keep||
7047|315|N|all medical and lab appointments. Consult your doctor for more||
7047|316|N|details.||
7047|317|B|||
7047|318|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7047|319|D|remember. If it is near the time of the next dose, skip the||
7047|320|D|missed dose. Take your next dose at the regular time. Do not||
7047|321|D|double the dose to catch up.||
7047|322|B|||
7047|323|R|STORAGE:  Store at room temperature away from light and moisture.||
7047|324|R|Do not store in the bathroom. Keep all medications away from||
7047|325|R|children and pets.||
7047|326|R|   Do not flush medications down the toilet or pour them into a||
7047|327|R|drain unless instructed to do so. Properly discard this product||
7047|328|R|when it is expired or no longer needed. Consult your pharmacist||
7047|329|R|or local waste disposal company.||
7047|330|B|||
7047|331|A|Information last revised July 2025.||
7047|332|A|Copyright(c) 2025 First Databank, Inc.||
7047|333|B|||
7048|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7048|002|Z|does NOT have all possible information about this product. This||
7048|003|Z|information does not assure that this product is safe, effective,||
7048|004|Z|or appropriate for you. This information is not individual||
7048|005|Z|medical advice and does not substitute for the advice of your||
7048|006|Z|health care professional. Always ask your health care||
7048|007|Z|professional for complete information about this product and your||
7048|008|Z|specific health needs.||
7048|009|B|||
7048|010|T|NITROGLYCERIN PATCH - TRANSDERMAL||
7048|011|F|(NYE-troe-GLIS-er-in)||
7048|012|B|||
7048|013|C|COMMON BRAND NAME(S): Nitro-Dur, Transderm-Nitro||
7048|014|B|||
7048|015|U|USES:  This medication is used to prevent chest pain (angina) in||
7048|016|U|people with a certain heart condition (coronary artery disease).||
7048|017|U|Nitroglycerin belongs to a class of drugs known as nitrates.||
7048|018|U|Angina occurs when the heart muscle is not getting enough blood.||
7048|019|U|This drug works by relaxing and widening blood vessels so blood||
7048|020|U|can flow more easily to the heart.||
7048|021|U|   This medication will not relieve chest pain once it occurs. It||
7048|022|U|is also not intended to be used just before physical activities||
7048|023|U|(such as exercise, sexual activity) to prevent chest pain. Other||
7048|024|U|medications may be needed in these situations. Consult your||
7048|025|U|doctor for more details.||
7048|026|B|||
7048|027|H|HOW TO USE:  Read the Patient Information Leaflet available from||
7048|028|H|your pharmacist. Consult your doctor or pharmacist if you have||
7048|029|H|any questions.||
7048|030|H|   Remove the patch from its pouch, and peel off the protective||
7048|031|H|clear liner as directed. Usually, you will wear the patch on the||
7048|032|H|upper arm or chest. However, you can wear it anywhere on the body||
7048|033|H|below the neck and above the knees or elbows. Apply the patch to||
7048|034|H|a clean, dry, and hairless area. Hair in the area may be clipped,||
7048|035|H|but not shaved. Avoid areas with cuts or irritation. Do not apply||
7048|036|H|the patch immediately after bathing or showering. Wait until your||
7048|037|H|skin is completely dry. However, you may bathe, shower, and swim||
7048|038|H|while wearing the patch. Press the patch firmly in place with the||
7048|039|H|palm of your hand. Wash your hands after applying the patch.||
7048|040|H|   Use this patch as directed by your doctor, usually 1 patch a||
7048|041|H|day, wearing it for 12 to 14 hours. The dosage is based on your||
7048|042|H|medical condition and response to treatment.||
7048|043|H|   To reduce skin irritation, apply each new patch to a different||
7048|044|H|area of skin. After removing the old patch, fold it in half with||
7048|045|H|the sticky sides together, and discard out of reach of children||
7048|046|H|and pets.||
7048|047|H|   Use this medication regularly to get the most benefit from it.||
7048|048|H|To help you remember, use it at the same time each day.||
7048|049|H|   Do not suddenly stop using this medication without consulting||
7048|050|H|your doctor. Some conditions may become worse when the drug is||
7048|051|H|suddenly stopped. Your dose may need to be gradually decreased.||
7048|052|H|   Although unlikely, when this medication is used for a long||
7048|053|H|time, it may not work as well and may require different dosing.||
7048|054|H|Tell your doctor if this medication stops working well (for||
7048|055|H|example, you have worsening chest pain or it occurs more often).||
7048|056|B|||
7048|057|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, nausea, and||
7048|058|S|flushing may occur as your body adjusts to this medication. If||
7048|059|S|any of these effects last or get worse, tell your doctor or||
7048|060|S|pharmacist promptly.||
7048|061|S|   Headache is often a sign that this medication is working. Your||
7048|062|S|doctor may recommend treating headaches with an over-the-counter||
7048|063|S|pain reliever (such as acetaminophen, aspirin). If the headaches||
7048|064|S|continue or become severe, tell your doctor promptly.||
7048|065|S|   To reduce the risk of dizziness and lightheadedness, get up||
7048|066|S|slowly when rising from a sitting or lying position.||
7048|067|S|   Remember that this medication has been prescribed because your||
7048|068|S|doctor has judged that the benefit to you is greater than the||
7048|069|S|risk of side effects. Many people using this medication do not||
7048|070|S|have serious side effects.||
7048|071|S|   Tell your doctor right away if you have any serious side||
7048|072|S|effects, including: fainting, fast/irregular/pounding heartbeat.||
7048|073|S|   A very serious allergic reaction to this drug is rare.||
7048|074|S|However, get medical help right away if you notice any symptoms||
7048|075|S|of a serious allergic reaction, including: rash, itching/swelling||
7048|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7048|077|S|breathing.||
7048|078|S|   This is not a complete list of possible side effects. If you||
7048|079|S|notice other effects not listed above, contact your doctor or||
7048|080|S|pharmacist.||
7048|081|S|   In the US -||
7048|082|S|   Call your doctor for medical advice about side effects. You||
7048|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7048|084|S|www.fda.gov/medwatch.||
7048|085|S|   In Canada - Call your doctor for medical advice about side||
7048|086|S|effects. You may report side effects to Health Canada at||
7048|087|S|1-866-234-2345.||
7048|088|B|||
7048|089|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
7048|090|P|pharmacist if you are allergic to it; or to similar drugs (such||
7048|091|P|as isosorbide mononitrate); or to nitrites; or if you have any||
7048|092|P|other allergies. This product may contain inactive ingredients,||
7048|093|P|which can cause allergic reactions or other problems. Talk to||
7048|094|P|your pharmacist for more details.||
7048|095|P|   Before using this medication, tell your doctor or pharmacist||
7048|096|P|your medical history, especially of: recent head injury, anemia,||
7048|097|P|low blood pressure, dehydration, other heart problems (such as||
7048|098|P|recent heart attack).||
7048|099|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7048|100|P|can make you more dizzy. Do not drive, use machinery, or do||
7048|101|P|anything that needs alertness until you can do it safely. Limit||
7048|102|P|alcoholic beverages. Talk to your doctor if you are using||
7048|103|P|marijuana (cannabis).||
7048|104|P|   Before having surgery, tell your doctor or dentist about all||
7048|105|P|the products you use (including prescription drugs,||
7048|106|P|nonprescription drugs, and herbal products).||
7048|107|P|   If you are going to have an MRI test, tell testing personnel||
7048|108|P|that you are using this patch. Some patches may contain metals||
7048|109|P|that can cause serious burns during an MRI. Ask your doctor||
7048|110|P|whether you will need to remove your patch before the test and||
7048|111|P|apply a new patch afterward, and how to do so properly.||
7048|112|P|   Older adults may be more sensitive to the side effects of this||
7048|113|P|medication, especially dizziness and lightheadedness, which could||
7048|114|P|increase the risk of falls.||
7048|115|P|   During pregnancy, this medication should be used only when||
7048|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
7048|117|P|   It is unknown if this drug passes into breast milk. Consult||
7048|118|P|your doctor before breastfeeding.||
7048|119|B|||
7048|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7048|121|I|medications work or increase your risk for serious side effects.||
7048|122|I|This document does not contain all possible drug interactions.||
7048|123|I|Keep a list of all the products you use (including||
7048|124|I|prescription/nonprescription drugs and herbal products) and share||
7048|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
7048|126|I|the dosage of any medicines without your doctor's approval.||
7048|127|I|   Some products that may interact with this drug include: drugs||
7048|128|I|used to treat erectile dysfunction-ED or pulmonary hypertension||
7048|129|I|(such as sildenafil, tadalafil), certain drugs to treat migraine||
7048|130|I|headaches (ergot alkaloids such as ergotamine), riociguat,||
7048|131|I|vericiguat.||
7048|132|I|   This medication may interfere with certain lab tests (such as||
7048|133|I|blood cholesterol levels), possibly causing false test results.||
7048|134|I|Make sure lab personnel and all your doctors know you use this||
7048|135|I|drug.||
7048|136|B|||
7048|137|O|OVERDOSE:  This medication patch may be harmful if chewed or||
7048|138|O|swallowed. If someone has overdosed, remove the patch if||
7048|139|O|possible. For serious symptoms such as passing out or trouble||
7048|140|O|breathing, call 911. Otherwise, call a poison control center||
7048|141|O|right away. US residents can call 1-800-222-1222. Canada||
7048|142|O|residents can call 1-844-764-7669. Symptoms of overdose may||
7048|143|O|include: slow heartbeat, vision changes, severe nausea/vomiting,||
7048|144|O|sweating, cold/clammy skin, bluish fingers/toes/lips.||
7048|145|B|||
7048|146|N|NOTES:  Do not share this medication with others.||
7048|147|N|   Lab and/or medical tests (such as blood pressure monitoring)||
7048|148|N|should be done while you are using this medication. Keep all||
7048|149|N|medical and lab appointments. Consult your doctor for more||
7048|150|N|details.||
7048|151|N|   Lifestyle changes such as dietary changes, exercise, and||
7048|152|N|stopping smoking may help this drug work better. Talk to your||
7048|153|N|doctor or pharmacist about lifestyle changes that might benefit||
7048|154|N|you.||
7048|155|B|||
7048|156|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
7048|157|D|remember. If it is near the time of the next dose, skip the||
7048|158|D|missed dose. Use your next dose at the regular time. Do not||
7048|159|D|double the dose to catch up.||
7048|160|B|||
7048|161|R|STORAGE:  Store at room temperature. Do not refrigerate. Keep all||
7048|162|R|medications away from children and pets.||
7048|163|R|   Do not flush medications down the toilet or pour them into a||
7048|164|R|drain unless instructed to do so. Properly discard this product||
7048|165|R|when it is expired or no longer needed (See How to Use section).||
7048|166|B|||
7048|167|M|MEDICAL ALERT:  Your condition can cause complications in a||
7048|168|M|medical emergency. For information about enrolling in MedicAlert,||
7048|169|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7048|170|B|||
7048|171|A|Information last revised January 2025.||
7048|172|A|Copyright(c) 2025 First Databank, Inc.||
7048|173|B|||
7049|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7049|002|Z|does NOT have all possible information about this product. This||
7049|003|Z|information does not assure that this product is safe, effective,||
7049|004|Z|or appropriate for you. This information is not individual||
7049|005|Z|medical advice and does not substitute for the advice of your||
7049|006|Z|health care professional. Always ask your health care||
7049|007|Z|professional for complete information about this product and your||
7049|008|Z|specific health needs.||
7049|009|B|||
7049|010|T|INDOMETHACIN - RECTAL||
7049|011|F|(IN-doe-METH-a-sin)||
7049|012|B|||
7049|013|C|COMMON BRAND NAME(S): Indocin||
7049|014|B|||
7049|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
7049|016|W|indomethacin) may rarely increase the risk for a heart attack or||
7049|017|W|stroke. This effect can happen at any time while using this drug||
7049|018|W|but is more likely if you use it for a long time. The risk may be||
7049|019|W|greater in older adults or if you have heart disease or increased||
7049|020|W|risk for heart disease (for example, due to smoking, family||
7049|021|W|history of heart disease, or conditions such as high blood||
7049|022|W|pressure or diabetes). Do not use this drug right before or after||
7049|023|W|heart bypass surgery (CABG).||
7049|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
7049|025|W|bleeding from the stomach or intestines. This effect can occur||
7049|026|W|without warning symptoms at any time while using this drug. Older||
7049|027|W|adults may be at increased risk for this effect.||
7049|028|W|   Stop using indomethacin and get medical help right away if you||
7049|029|W|notice any of these rare but serious side effects:||
7049|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
7049|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
7049|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
7049|033|W|side of the body, trouble speaking, sudden vision changes.||
7049|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
7049|035|W|of using this drug.||
7049|036|B|||
7049|037|U|USES:  Indomethacin is used to relieve pain, swelling, and joint||
7049|038|U|stiffness caused by arthritis, gout, bursitis, and tendonitis.||
7049|039|U|Reducing these symptoms helps you do more of your normal daily||
7049|040|U|activities. This medication is known as a nonsteroidal||
7049|041|U|anti-inflammatory drug (NSAID).||
7049|042|U|   If you are treating a chronic condition such as arthritis, ask||
7049|043|U|your doctor about non-drug treatments and/or using other||
7049|044|U|medications to treat your pain. See also Warning section.||
7049|045|B|||
7049|046|V|OTHER USES:  This section contains uses of this drug that are not||
7049|047|V|listed in the approved professional labeling for the drug but||
7049|048|V|that may be prescribed by your health care professional. Use this||
7049|049|V|drug for a condition that is listed in this section only if it||
7049|050|V|has been so prescribed by your health care professional.||
7049|051|V|   This medication may also be used to relieve pain caused by||
7049|052|V|inflammation of the pouch surrounding the heart and other||
7049|053|V|conditions as prescribed by your doctor.||
7049|054|B|||
7049|055|H|HOW TO USE:  Read the Medication Guide provided by your||
7049|056|H|pharmacist before you start using indomethacin and each time you||
7049|057|H|get a refill. If you have any questions, ask your doctor or||
7049|058|H|pharmacist.||
7049|059|H|   If the suppository is too soft to insert, put it in cold water||
7049|060|H|or refrigerate it for 30 minutes before removing the foil||
7049|061|H|wrapper. Unwrap the foil and moisten the suppository with a||
7049|062|H|little water. Lie down on your left side with right knee bent.||
7049|063|H|Push the suppository into the rectum with your finger. Remain||
7049|064|H|lying down for a few minutes, and avoid having a bowel movement||
7049|065|H|for at least an hour to allow the drug to be completely absorbed.||
7049|066|H|   The dosage is based on your medical condition and response to||
7049|067|H|treatment. Children's dosage is also based on weight. To reduce||
7049|068|H|your risk of stomach bleeding and other side effects, use this||
7049|069|H|medication at the lowest effective dose for the shortest possible||
7049|070|H|time. Do not increase your dose or use this drug more often or||
7049|071|H|for longer than prescribed. For ongoing conditions such as||
7049|072|H|arthritis, keep using this medication as directed. Discuss the||
7049|073|H|risks and benefits with your doctor or pharmacist.||
7049|074|H|   For certain conditions (such as arthritis), it may take up to||
7049|075|H|4 weeks of using this drug regularly before you get the full||
7049|076|H|benefit.||
7049|077|H|   If you are using this drug "as needed" (not on a regular||
7049|078|H|schedule), remember that pain medications work best if they are||
7049|079|H|used as the first signs of pain occur. If you wait until the pain||
7049|080|H|has worsened, the medication may not work as well.||
7049|081|H|   Tell your doctor if your condition gets worse.||
7049|082|B|||
7049|083|S|SIDE EFFECTS:  See also Warning section.||
7049|084|S|   Upset stomach, heartburn, headache, drowsiness, or dizziness||
7049|085|S|may occur. If any of these effects last or get worse, tell your||
7049|086|S|doctor or pharmacist promptly.||
7049|087|S|   Remember that this medication has been prescribed because your||
7049|088|S|doctor has judged that the benefit to you is greater than the||
7049|089|S|risk of side effects. Many people using this medication do not||
7049|090|S|have serious side effects.||
7049|091|S|   This medication may raise your blood pressure. Check your||
7049|092|S|blood pressure regularly and tell your doctor if the results are||
7049|093|S|high.||
7049|094|S|   Tell your doctor right away if you have any serious side||
7049|095|S|effects, including: rectal irritation, bloody stools, feeling the||
7049|096|S|need to have frequent bowel movements, easy bruising/bleeding,||
7049|097|S|hearing changes (such as ringing in the ears), mental/mood||
7049|098|S|changes (such as confusion, hallucinations), signs of kidney||
7049|099|S|problems (such as change in the amount of urine), symptoms of||
7049|100|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
7049|101|S|unusual/sudden weight gain).||
7049|102|S|   This drug may rarely cause serious (possibly fatal) liver||
7049|103|S|disease. Get medical help right away if you have any symptoms of||
7049|104|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
7049|105|S|of appetite, dark urine, severe stomach/abdominal pain, yellowing||
7049|106|S|eyes/skin.||
7049|107|S|   A very serious allergic reaction to this drug is rare.||
7049|108|S|However, get medical help right away if you notice any symptoms||
7049|109|S|of a serious allergic reaction, including: fever, swollen lymph||
7049|110|S|nodes, rash, itching/swelling (especially of the||
7049|111|S|face/tongue/throat), severe dizziness, trouble breathing.||
7049|112|S|   This is not a complete list of possible side effects. If you||
7049|113|S|notice other effects not listed above, contact your doctor or||
7049|114|S|pharmacist.||
7049|115|S|   In the US -||
7049|116|S|   Call your doctor for medical advice about side effects. You||
7049|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7049|118|S|www.fda.gov/medwatch.||
7049|119|S|   In Canada - Call your doctor for medical advice about side||
7049|120|S|effects. You may report side effects to Health Canada at||
7049|121|S|1-866-234-2345.||
7049|122|B|||
7049|123|P|PRECAUTIONS:  Before using indomethacin, tell your doctor or||
7049|124|P|pharmacist if you are allergic to it; or to aspirin or other||
7049|125|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have||
7049|126|P|any other allergies. This product may contain inactive||
7049|127|P|ingredients, which can cause allergic reactions or other||
7049|128|P|problems. Talk to your pharmacist for more details.||
7049|129|P|   Before using this medication, tell your doctor or pharmacist||
7049|130|P|your medical history, especially of: recent rectal bleeding,||
7049|131|P|inflammation of the rectum/anus, asthma (including a history of||
7049|132|P|worsening breathing after taking aspirin or other NSAIDs),||
7049|133|P|bleeding or clotting problems, growths in the nose (nasal||
7049|134|P|polyps), heart disease (such as history of heart attack), high||
7049|135|P|blood pressure, liver disease, stomach/intestine/esophagus||
7049|136|P|problems (such as bleeding, ulcers, recurring heartburn), stroke.||
7049|137|P|   Kidney problems can sometimes occur with the use of NSAID||
7049|138|P|medications, including indomethacin. Problems are more likely to||
7049|139|P|occur if you are dehydrated, have heart failure or kidney||
7049|140|P|disease, are an older adult, or if you take certain medications||
7049|141|P|(see also Drug Interactions section). Drink plenty of fluids as||
7049|142|P|directed by your doctor to prevent dehydration and tell your||
7049|143|P|doctor right away if you have a change in the amount of urine.||
7049|144|P|   Before having surgery, tell your doctor or dentist about all||
7049|145|P|the products you use (including prescription drugs,||
7049|146|P|nonprescription drugs, and herbal products).||
7049|147|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7049|148|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7049|149|P|machinery, or do anything that needs alertness until you can do||
7049|150|P|it safely. Talk to your doctor if you are using marijuana||
7049|151|P|(cannabis).||
7049|152|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
7049|153|P|and tobacco may increase your risk for stomach bleeding,||
7049|154|P|especially when combined with this medicine. Limit alcohol and||
7049|155|P|stop smoking. Consult your doctor or pharmacist for more||
7049|156|P|information.||
7049|157|P|   This medication may make you more sensitive to the sun. Limit||
7049|158|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
7049|159|P|sunscreen and wear protective clothing when outdoors. Tell your||
7049|160|P|doctor right away if you get sunburned or have skin||
7049|161|P|blisters/redness.||
7049|162|P|   Older adults may be at greater risk for stomach/intestinal||
7049|163|P|bleeding, kidney problems, heart attack, stroke, and mental/mood||
7049|164|P|changes while using this drug.||
7049|165|P|   Children may be more sensitive to the side effects of this||
7049|166|P|drug, especially serious liver problems. Caution is advised when||
7049|167|P|this drug is used by children. Discuss the risks and benefits of||
7049|168|P|treatment with your doctor.||
7049|169|P|   Before using this medication, women of childbearing age should||
7049|170|P|talk with their doctor(s) about the benefits and risks. Tell your||
7049|171|P|doctor if you are pregnant or if you plan to become pregnant.||
7049|172|P|This medication may harm an unborn baby and cause problems with||
7049|173|P|normal labor/delivery. It is not recommended for use in pregnancy||
7049|174|P|from 20 weeks until delivery. If your doctor decides that you||
7049|175|P|need to use this medication between 20 and 30 weeks of pregnancy,||
7049|176|P|you should use the lowest effective dose for the shortest||
7049|177|P|possible time. You should not use this medication after 30 weeks||
7049|178|P|of pregnancy.||
7049|179|P|   This drug passes into breast milk and may have undesirable||
7049|180|P|effects on a nursing infant. Consult your doctor before||
7049|181|P|breastfeeding.||
7049|182|B|||
7049|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7049|184|I|medications work or increase your risk for serious side effects.||
7049|185|I|This document does not contain all possible drug interactions.||
7049|186|I|Keep a list of all the products you use (including||
7049|187|I|prescription/nonprescription drugs and herbal products) and share||
7049|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
7049|189|I|the dosage of any medicines without your doctor's approval.||
7049|190|I|   Some products that may interact with this drug include:||
7049|191|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
7049|192|I|angiotensin II receptor blockers (such as valsartan, losartan),||
7049|193|I|cidofovir, corticosteroids (such as prednisone), lithium,||
7049|194|I|methotrexate (high-dose treatment), "water pills" (diuretics such||
7049|195|I|as furosemide).||
7049|196|I|   This medication may increase the risk of bleeding when used||
7049|197|I|with other drugs that also may cause bleeding. Examples include||
7049|198|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
7049|199|I|dabigatran/enoxaparin/warfarin, among others.||
7049|200|I|   Check all prescription and nonprescription medicine labels||
7049|201|I|carefully since many medications contain pain relievers/fever||
7049|202|I|reducers (aspirin, NSAIDs such as celecoxib, diflunisal,||
7049|203|I|ibuprofen, or ketorolac). These drugs are similar to indomethacin||
7049|204|I|and may increase your risk of side effects if taken together.||
7049|205|I|However, if your doctor has told you to take low-dose aspirin to||
7049|206|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
7049|207|I|you should keep taking the aspirin unless your doctor tells you||
7049|208|I|not to. Ask your doctor or pharmacist for more details.||
7049|209|I|   This medication may interfere with certain lab tests, possibly||
7049|210|I|causing false test results. Make sure lab personnel and all your||
7049|211|I|doctors know you use this drug.||
7049|212|B|||
7049|213|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7049|214|O|has overdosed and has serious symptoms such as passing out or||
7049|215|O|trouble breathing, call 911. Otherwise, call a poison control||
7049|216|O|center right away. US residents can call 1-800-222-1222. Canada||
7049|217|O|residents can call 1-844-764-7669. If accidentally swallowed, you||
7049|218|O|may experience symptoms such as: severe stomach pain, vomit that||
7049|219|O|looks like coffee grounds, extreme drowsiness, slow or shallow||
7049|220|O|breathing, confusion, seizures.||
7049|221|B|||
7049|222|N|NOTES:  Do not share this medication with others.||
7049|223|N|   Lab and/or medical tests (such as blood pressure, complete||
7049|224|N|blood count, liver/kidney function) may be done while you are||
7049|225|N|using this medication. Keep all medical and lab appointments.||
7049|226|N|Consult your doctor for more details.||
7049|227|N|   Lifestyle changes (such as weight loss if needed,||
7049|228|N|strengthening/conditioning exercises) may help improve your||
7049|229|N|flexibility, range of motion, and joint function. Consult your||
7049|230|N|doctor for specific instructions.||
7049|231|B|||
7049|232|D|MISSED DOSE:  If you are prescribed this drug on a regular||
7049|233|D|schedule (not just "as needed") and you miss a dose, use it as||
7049|234|D|soon as you remember. If it is near the time of the next dose,||
7049|235|D|skip the missed dose. Use your next dose at the regular time. Do||
7049|236|D|not double the dose to catch up.||
7049|237|B|||
7049|238|R|STORAGE:  Some brands may require refrigeration while others||
7049|239|R|should not be refrigerated. Check the product package for||
7049|240|R|instructions on how to store your product. If you have any||
7049|241|R|questions about storage, ask your pharmacist. Keep all||
7049|242|R|medications away from children and pets.||
7049|243|R|   Do not flush medications down the toilet or pour them into a||
7049|244|R|drain unless instructed to do so. Properly discard this product||
7049|245|R|when it is expired or no longer needed. Consult your pharmacist||
7049|246|R|or local waste disposal company.||
7049|247|B|||
7049|248|A|Information last revised November 2024.||
7049|249|A|Copyright(c) 2025 First Databank, Inc.||
7049|250|B|||
7050|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7050|002|Z|does NOT have all possible information about this product. This||
7050|003|Z|information does not assure that this product is safe, effective,||
7050|004|Z|or appropriate for you. This information is not individual||
7050|005|Z|medical advice and does not substitute for the advice of your||
7050|006|Z|health care professional. Always ask your health care||
7050|007|Z|professional for complete information about this product and your||
7050|008|Z|specific health needs.||
7050|009|B|||
7050|010|T|AMPICILLIN/SULBACTAM - INJECTION||
7050|011|F|(AM-pi-SIL-in/sul-BAK-tam)||
7050|012|B|||
7050|013|C|COMMON BRAND NAME(S): Unasyn||
7050|014|B|||
7050|015|U|USES:  This combination medication is used to treat a wide||
7050|016|U|variety of bacterial infections. It is known as a penicillin-type||
7050|017|U|antibiotic. It works by stopping the growth of bacteria.||
7050|018|B|||
7050|019|H|HOW TO USE:  This medication is given by injection into a vein as||
7050|020|H|directed by your doctor, usually every 6 hours. The dosage is||
7050|021|H|based on your medical condition and response to treatment.||
7050|022|H|Children's dosage is also based on weight.||
7050|023|H|   If you are giving this medication to yourself at home, learn||
7050|024|H|all preparation and usage instructions from your health care||
7050|025|H|professional. Before using, check this product for particles or||
7050|026|H|discoloration. If either is present, do not use the liquid. Learn||
7050|027|H|how to store and discard medical supplies safely.||
7050|028|H|   Give aminoglycosides (such as gentamicin) separately from this||
7050|029|H|medication. Do not mix together in the same IV fluid.||
7050|030|H|   For the best effect, use this antibiotic at evenly spaced||
7050|031|H|times. To help you remember, use this medication at the same||
7050|032|H|time(s) every day.||
7050|033|H|   Continue to use this medication until the full prescribed||
7050|034|H|amount is finished, even if symptoms disappear after a few days.||
7050|035|H|Stopping the medication too early may result in a return of the||
7050|036|H|infection.||
7050|037|H|   Tell your doctor if your condition lasts or gets worse.||
7050|038|B|||
7050|039|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. If this||
7050|040|S|medication is injected into a muscle, pain at the injection site||
7050|041|S|may occur. If any of these effects last or get worse, tell your||
7050|042|S|doctor or pharmacist promptly.||
7050|043|S|   Remember that this medication has been prescribed because your||
7050|044|S|doctor has judged that the benefit to you is greater than the||
7050|045|S|risk of side effects. Many people using this medication do not||
7050|046|S|have serious side effects.||
7050|047|S|   Tell your doctor right away if you have any serious side||
7050|048|S|effects, including: pain/swelling at injection site (if this drug||
7050|049|S|is injected into a vein), chest pain, difficult/painful||
7050|050|S|urination, easy bruising/bleeding, signs of liver disease (such||
7050|051|S|as nausea/vomiting that doesn't stop, loss of appetite,||
7050|052|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
7050|053|S|   This medication may rarely cause a severe intestinal condition||
7050|054|S|due to a bacteria called C. difficile. This condition may occur||
7050|055|S|during treatment or weeks to months after treatment has stopped.||
7050|056|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7050|057|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7050|058|S|stool.||
7050|059|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7050|060|S|products because they may make symptoms worse.||
7050|061|S|   Use of this medication for prolonged or repeated periods may||
7050|062|S|result in oral thrush or a new vaginal yeast infection. Contact||
7050|063|S|your doctor if you notice white patches in your mouth, a change||
7050|064|S|in vaginal discharge, or other new symptoms.||
7050|065|S|   A very serious allergic reaction to this drug is rare.||
7050|066|S|However, get medical help right away if you notice any symptoms||
7050|067|S|of a serious allergic reaction, including: fever that doesn't go||
7050|068|S|away, new or worsening lymph node swelling, rash,||
7050|069|S|itching/swelling (especially of the face/tongue/throat), severe||
7050|070|S|dizziness, trouble breathing.||
7050|071|S|   Ampicillin can commonly cause a mild rash that is usually not||
7050|072|S|serious. However, you may not be able to tell it apart from a||
7050|073|S|rare rash that could be a sign of a severe allergic reaction. Get||
7050|074|S|medical help right away if you develop any rash.||
7050|075|S|   This is not a complete list of possible side effects. If you||
7050|076|S|notice other effects not listed above, contact your doctor or||
7050|077|S|pharmacist.||
7050|078|S|   In the US -||
7050|079|S|   Call your doctor for medical advice about side effects. You||
7050|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7050|081|S|www.fda.gov/medwatch.||
7050|082|S|   In Canada - Call your doctor for medical advice about side||
7050|083|S|effects. You may report side effects to Health Canada at||
7050|084|S|1-866-234-2345.||
7050|085|B|||
7050|086|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
7050|087|P|pharmacist if you are allergic to it; or to penicillin or||
7050|088|P|cephalosporin antibiotics; or if you have any other allergies.||
7050|089|P|This product may contain inactive ingredients, which can cause||
7050|090|P|allergic reactions or other problems. Talk to your pharmacist for||
7050|091|P|more details.||
7050|092|P|   Before using this medication, tell your doctor or pharmacist||
7050|093|P|your medical history, especially of: viral infections (such as||
7050|094|P|infectious mononucleosis), kidney disease, liver disease||
7050|095|P|(especially if caused by past use of ampicillin/sulbactam).||
7050|096|P|   This medication contains sodium. Consult your doctor or||
7050|097|P|pharmacist if you are on a salt-restricted diet or if you have a||
7050|098|P|condition that could be worsened by an increase in salt intake||
7050|099|P|(such as heart failure).||
7050|100|P|   This medication may cause live bacterial vaccines (such as||
7050|101|P|typhoid vaccine) to not work well. Tell your health care||
7050|102|P|professional that you are using this medication before having any||
7050|103|P|immunizations/vaccinations.||
7050|104|P|   Older adults may be at greater risk for side effects while||
7050|105|P|using this drug.||
7050|106|P|   During pregnancy, this medication should be used only when||
7050|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
7050|108|P|   This medication passes into breast milk. Consult your doctor||
7050|109|P|before breastfeeding.||
7050|110|B|||
7050|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7050|112|I|medications work or increase your risk for serious side effects.||
7050|113|I|This document does not contain all possible drug interactions.||
7050|114|I|Keep a list of all the products you use (including||
7050|115|I|prescription/nonprescription drugs and herbal products) and share||
7050|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
7050|117|I|the dosage of any medicines without your doctor's approval.||
7050|118|I|   Some products that may interact with this drug include:||
7050|119|I|aminoglycosides (such as gentamicin), "blood thinners" (such as||
7050|120|I|warfarin), methotrexate, tetracyclines.||
7050|121|I|   This medication may interfere with certain lab tests (such as||
7050|122|I|certain urine glucose tests), possibly causing false test||
7050|123|I|results. Make sure lab personnel and all your doctors know you||
7050|124|I|use this drug.||
7050|125|B|||
7050|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7050|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7050|128|O|poison control center right away. US residents can call||
7050|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7050|130|O|Symptoms of overdose may include: seizures.||
7050|131|B|||
7050|132|N|NOTES:  Lab and/or medical tests (such as kidney function,||
7050|133|N|complete blood count) may be done while you are using this||
7050|134|N|medication. Keep all medical and lab appointments. Consult your||
7050|135|N|doctor for more details.||
7050|136|B|||
7050|137|D|MISSED DOSE:  It is important to get each dose of this medication||
7050|138|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7050|139|D|right away for a new dosing schedule. Do not double the dose to||
7050|140|D|catch up.||
7050|141|B|||
7050|142|R|STORAGE:  Consult the product instructions and your pharmacist||
7050|143|R|for storage details. Keep all medications away from children and||
7050|144|R|pets.||
7050|145|R|   Do not flush medications down the toilet or pour them into a||
7050|146|R|drain unless instructed to do so. Properly discard this product||
7050|147|R|when it is expired or no longer needed. Consult your pharmacist||
7050|148|R|or local waste disposal company.||
7050|149|B|||
7050|150|A|Information last revised February 2025.||
7050|151|A|Copyright(c) 2025 First Databank, Inc.||
7050|152|B|||
7051|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7051|002|Z|does NOT have all possible information about this product. This||
7051|003|Z|information does not assure that this product is safe, effective,||
7051|004|Z|or appropriate for you. This information is not individual||
7051|005|Z|medical advice and does not substitute for the advice of your||
7051|006|Z|health care professional. Always ask your health care||
7051|007|Z|professional for complete information about this product and your||
7051|008|Z|specific health needs.||
7051|009|B|||
7051|010|T|SUMATRIPTAN SPRAY - NASAL||
7051|011|F|(SOO-ma-TRIP-tan)||
7051|012|B|||
7051|013|C|COMMON BRAND NAME(S): Imitrex, Tosymra||
7051|014|B|||
7051|015|U|USES:  Sumatriptan is used to treat migraines. It helps to||
7051|016|U|relieve headache, pain, and other migraine symptoms (including||
7051|017|U|nausea, vomiting, sensitivity to light/sound). Prompt treatment||
7051|018|U|helps you return to your normal routine and may decrease your||
7051|019|U|need for other pain medications. Sumatriptan belongs to a class||
7051|020|U|of drugs known as triptans. It affects a certain natural||
7051|021|U|substance (serotonin) that causes narrowing of blood vessels in||
7051|022|U|the brain. It may also relieve pain by affecting certain nerves||
7051|023|U|in the brain.||
7051|024|U|   Sumatriptan does not prevent future migraines or lessen how||
7051|025|U|often you get migraine attacks.||
7051|026|B|||
7051|027|H|HOW TO USE:  Read the Patient Information Leaflet and||
7051|028|H|Instructions for Use if available from your pharmacist before you||
7051|029|H|start using sumatriptan spray and each time you get a refill.||
7051|030|H|This medication comes in different brands with different||
7051|031|H|strengths. Carefully read and follow the instructions for your||
7051|032|H|brand. If you have any questions, ask your doctor or pharmacist.||
7051|033|H|   This product is for use in the nose only. Remove the||
7051|034|H|sumatriptan spray from the package only when you are ready to use||
7051|035|H|it. Do not test or prime the spray before use. Doing so will make||
7051|036|H|you lose the dose.||
7051|037|H|   Use this medication at the first sign of a migraine as||
7051|038|H|directed by your doctor, usually 1 spray into one nostril. Avoid||
7051|039|H|spraying into your eyes. Gently blow your nose before using this||
7051|040|H|medication. Keeping your head upright, close one nostril by||
7051|041|H|pressing with your index finger on one side of your nose. You may||
7051|042|H|tilt your head back slightly to keep the medicine from dripping||
7051|043|H|out of your nose. Place the nozzle of the spray device into the||
7051|044|H|other nostril and breathe in gently as you press the plunger.||
7051|045|H|Keep your head upright, remove the nozzle from your nose, and||
7051|046|H|gently breathe in through your nose and out through your mouth||
7051|047|H|for 10 to 20 seconds. Your nose may feel wet inside and you may||
7051|048|H|notice a slight taste after using the spray. This is normal.||
7051|049|H|   If there is no improvement in your symptoms, do not take more||
7051|050|H|doses of this medication before talking to your doctor. If your||
7051|051|H|symptoms are only partly relieved, or if your headache comes||
7051|052|H|back, you may use another dose after at least 1 or at least 2||
7051|053|H|hours (depending on your brand). The dosage is based on your||
7051|054|H|medical condition and response to treatment.||
7051|055|H|   If you have a higher risk for heart problems (see||
7051|056|H|Precautions), your doctor may perform a heart exam before you||
7051|057|H|start taking sumatriptan. He/she may also direct you to take your||
7051|058|H|first dose of this medication in the office/clinic to monitor for||
7051|059|H|serious side effects (such as chest pain). Talk to your doctor||
7051|060|H|for details.||
7051|061|H|   If you are using drugs for migraine attacks on 10 or more days||
7051|062|H|each month, the drugs may actually make your headaches worse||
7051|063|H|(medication overuse headache). Do not use medications more often||
7051|064|H|or for longer than directed. Tell your doctor if you need to use||
7051|065|H|this medication more often, or if the medication is not working||
7051|066|H|as well, or if your headaches get worse.||
7051|067|B|||
7051|068|S|SIDE EFFECTS:  Unusual taste or irritation/numbness/tingling of||
7051|069|S|the nose or throat may occur after using the spray. Flushing,||
7051|070|S|feelings of tingling/numbness/prickling/heat, tiredness,||
7051|071|S|weakness, drowsiness, or dizziness may also occur. If any of||
7051|072|S|these effects last or get worse, tell your doctor or pharmacist||
7051|073|S|promptly.||
7051|074|S|   Remember that this medication has been prescribed because your||
7051|075|S|doctor has judged that the benefit to you is greater than the||
7051|076|S|risk of side effects. Many people using this medication do not||
7051|077|S|have serious side effects.||
7051|078|S|   This medication may raise your blood pressure. Check your||
7051|079|S|blood pressure regularly and tell your doctor if the results are||
7051|080|S|high.||
7051|081|S|   Tell your doctor right away if you have any serious side||
7051|082|S|effects, including: blue fingers/toes/nails, cold hands/feet,||
7051|083|S|hearing changes, mental/mood changes.||
7051|084|S|   Sumatriptan can commonly cause chest/jaw/neck tightness, pain,||
7051|085|S|or pressure that is usually not serious. However, these side||
7051|086|S|effects are like symptoms of a heart attack, which may include||
7051|087|S|chest/jaw/left arm pain, shortness of breath, or unusual||
7051|088|S|sweating. Get medical help right away if these or other serious||
7051|089|S|side effects occur, including: fast/irregular heartbeat,||
7051|090|S|fainting, severe stomach/abdominal pain, bloody diarrhea,||
7051|091|S|seizure, signs of a stroke (such as weakness on one side of the||
7051|092|S|body, trouble speaking, sudden vision changes, confusion).||
7051|093|S|   This medication may increase serotonin and rarely cause a very||
7051|094|S|serious condition called serotonin syndrome/toxicity. The risk||
7051|095|S|increases if you are also taking other drugs that increase||
7051|096|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
7051|097|S|take (see Drug Interactions section). Get medical help right away||
7051|098|S|if you develop some of the following symptoms: fast heartbeat,||
7051|099|S|hallucinations, loss of coordination, severe dizziness, severe||
7051|100|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
7051|101|S|unusual agitation/restlessness.||
7051|102|S|   A very serious allergic reaction to this drug is rare.||
7051|103|S|However, get medical help right away if you notice any symptoms||
7051|104|S|of a serious allergic reaction, including: rash, itching/swelling||
7051|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7051|106|S|breathing.||
7051|107|S|   This is not a complete list of possible side effects. If you||
7051|108|S|notice other effects not listed above, contact your doctor or||
7051|109|S|pharmacist.||
7051|110|S|   In the US -||
7051|111|S|   Call your doctor for medical advice about side effects. You||
7051|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7051|113|S|www.fda.gov/medwatch.||
7051|114|S|   In Canada - Call your doctor for medical advice about side||
7051|115|S|effects. You may report side effects to Health Canada at||
7051|116|S|1-866-234-2345.||
7051|117|B|||
7051|118|P|PRECAUTIONS:  Before using sumatriptan, tell your doctor or||
7051|119|P|pharmacist if you are allergic to it; or if you have any other||
7051|120|P|allergies. This product may contain inactive ingredients, which||
7051|121|P|can cause allergic reactions or other problems. Talk to your||
7051|122|P|pharmacist for more details.||
7051|123|P|   Before using this medication, tell your doctor or pharmacist||
7051|124|P|your medical history, especially of: blood circulation problems||
7051|125|P|(for example, in your legs, arms/hands, or stomach), certain||
7051|126|P|types of headaches (hemiplegic or basilar migraine), heart||
7051|127|P|problems (such as chest pain, irregular heartbeat, previous heart||
7051|128|P|attack), liver disease, seizure, stroke or "mini-stroke"||
7051|129|P|(transient ischemic attack).||
7051|130|P|   Certain conditions can increase your risk for heart problems.||
7051|131|P|Tell your doctor if you have any of these conditions, including:||
7051|132|P|high blood pressure, high cholesterol, diabetes, family history||
7051|133|P|of heart disease, overweight, smoker, postmenopausal (women), age||
7051|134|P|more than 40 years (men).||
7051|135|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7051|136|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7051|137|P|machinery, or do anything that needs alertness until you can do||
7051|138|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
7051|139|P|are using marijuana (cannabis).||
7051|140|P|   Before having surgery, tell your doctor or dentist about all||
7051|141|P|the products you use (including prescription drugs,||
7051|142|P|nonprescription drugs, and herbal products).||
7051|143|P|   The risk of heart disease, liver disease, and high blood||
7051|144|P|pressure increases with age. Older adults may be more sensitive||
7051|145|P|to the side effects of this drug, especially increased blood||
7051|146|P|pressure and heart problems.||
7051|147|P|   During pregnancy, this medication should be used only when||
7051|148|P|clearly needed. Discuss the risks and benefits with your doctor.||
7051|149|P|   This drug passes into breast milk in small amounts. Consult||
7051|150|P|your doctor before breastfeeding.||
7051|151|B|||
7051|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7051|153|I|medications work or increase your risk for serious side effects.||
7051|154|I|This document does not contain all possible drug interactions.||
7051|155|I|Keep a list of all the products you use (including||
7051|156|I|prescription/nonprescription drugs and herbal products) and share||
7051|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
7051|158|I|the dosage of any medicines without your doctor's approval.||
7051|159|I|   Taking MAO inhibitors with this medication may cause a serious||
7051|160|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
7051|161|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
7051|162|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
7051|163|I|selegiline, tranylcypromine) during treatment with this||
7051|164|I|medication. Most MAO inhibitors should also not be taken for two||
7051|165|I|weeks before treatment with this medication. Ask your doctor when||
7051|166|I|to start or stop taking this medication.||
7051|167|I|   The risk of serotonin syndrome/toxicity increases if you are||
7051|168|I|also taking other drugs that increase serotonin. Examples include||
7051|169|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
7051|170|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
7051|171|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
7051|172|I|serotonin syndrome/toxicity may be more likely when you start or||
7051|173|I|increase the dose of these drugs.||
7051|174|I|   If you also take any ergotamine medication (such as||
7051|175|I|dihydroergotamine) or other "triptan" drugs (such as||
7051|176|I|zolmitriptan, rizatriptan), you will need to separate your||
7051|177|I|sumatriptan dose from your dose of these other medications to||
7051|178|I|lessen the chance of serious side effects. Ask your doctor how||
7051|179|I|long you should wait between your doses of these drugs.||
7051|180|B|||
7051|181|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7051|182|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7051|183|O|poison control center right away. US residents can call||
7051|184|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7051|185|B|||
7051|186|N|NOTES:  Do not share this medication with others.||
7051|187|N|   Certain foods, beverages, or food additives (such as red wine,||
7051|188|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
7051|189|N|patterns such as irregular eating/sleeping habits or stress may||
7051|190|N|bring on a migraine headache. Avoiding these "triggers" may help||
7051|191|N|lessen migraine attacks. Consult your doctor for more details.||
7051|192|N|   Lab and/or medical tests (such as blood pressure) may be done||
7051|193|N|while you are using this medication. Keep all medical and lab||
7051|194|N|appointments. Consult your doctor for more details.||
7051|195|B|||
7051|196|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
7051|197|B|||
7051|198|R|STORAGE:  Different brands of this medication have different||
7051|199|R|storage needs. Check the product package for instructions on how||
7051|200|R|to store your brand, or ask your pharmacist. Keep all medications||
7051|201|R|away from children and pets.||
7051|202|R|   Do not flush medications down the toilet or pour them into a||
7051|203|R|drain unless instructed to do so. Properly discard this product||
7051|204|R|when it is expired or no longer needed. Consult your pharmacist||
7051|205|R|or local waste disposal company.||
7051|206|B|||
7051|207|A|Information last revised May 2024.||
7051|208|A|Copyright(c) 2025 First Databank, Inc.||
7051|209|B|||
7052|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7052|002|Z|does NOT have all possible information about this product. This||
7052|003|Z|information does not assure that this product is safe, effective,||
7052|004|Z|or appropriate for you. This information is not individual||
7052|005|Z|medical advice and does not substitute for the advice of your||
7052|006|Z|health care professional. Always ask your health care||
7052|007|Z|professional for complete information about this product and your||
7052|008|Z|specific health needs.||
7052|009|B|||
7052|010|T|NYSTATIN/TRIAMCINOLONE - TOPICAL||
7052|011|F|(NYE-stat-in/TRYE-am-SIN-oh-lone)||
7052|012|B|||
7052|013|C|COMMON BRAND NAME(S): Mycolog II||
7052|014|B|||
7052|015|U|USES:  This medication is used to treat fungal skin infections.||
7052|016|U|This product contains nystatin, an anti-fungal drug that works by||
7052|017|U|stopping the growth of fungus. It also contains triamcinolone, an||
7052|018|U|anti-inflammatory corticosteroid that works by reducing swelling,||
7052|019|U|itching, and redness.||
7052|020|U|   This medication treats only fungal skin infections. It will||
7052|021|U|not work for other types of skin infections (such as infections||
7052|022|U|caused by bacteria, viruses). Unnecessary use or misuse of any||
7052|023|U|antibiotic can lead to its decreased effectiveness.||
7052|024|B|||
7052|025|H|HOW TO USE:  Use this medication only on the skin. Wash and dry||
7052|026|H|your hands before using. Clean and dry the affected area. Then||
7052|027|H|apply a small amount of medication in a thin layer on the skin||
7052|028|H|and rub in gently as directed by your doctor, usually twice a day||
7052|029|H|(in the morning and evening). Wash your hands after use, unless||
7052|030|H|you are using this product to treat the hands.||
7052|031|H|   Do not bandage, cover, or wrap the treated area unless you are||
7052|032|H|instructed to do so by your doctor. If you are using this||
7052|033|H|medication on a child's diaper area, do not use tight-fitting||
7052|034|H|diapers or plastic pants.||
7052|035|H|   If you are directed to use this medication in the groin area,||
7052|036|H|apply it sparingly and wear loose-fitting clothes.||
7052|037|H|   Avoid getting this medication in your eyes, nose, or mouth. If||
7052|038|H|this occurs, wipe off the medication and rinse thoroughly with||
7052|039|H|water.||
7052|040|H|   Use this medication only for the condition for which it was||
7052|041|H|prescribed. Do not use large amounts of this medication or apply||
7052|042|H|this more often or for a longer period than directed. Use this||
7052|043|H|medication regularly in order to get the most benefit from it. To||
7052|044|H|help you remember, use it at the same times each day.||
7052|045|H|   Continue to use this medication for the full time prescribed,||
7052|046|H|even if symptoms disappear after a few days. Stopping the||
7052|047|H|medication too early may result in a return of the infection.||
7052|048|H|   Tell your doctor if your condition does not get better after 1||
7052|049|H|week or if it gets worse.||
7052|050|B|||
7052|051|S|SIDE EFFECTS:  Skin irritation, burning, or dryness may occur.||
7052|052|S|These effects should lessen in a few days as your body adjusts to||
7052|053|S|the medication. If any of these effects last or get worse, tell||
7052|054|S|your doctor or pharmacist promptly.||
7052|055|S|   Remember that this medication has been prescribed because your||
7052|056|S|doctor has judged that the benefit to you is greater than the||
7052|057|S|risk of side effects. Many people using this medication do not||
7052|058|S|have serious side effects.||
7052|059|S|   Tell your doctor right away if you have any serious side||
7052|060|S|effects, including: stretch marks, skin thinning/discoloration,||
7052|061|S|acne, increased/unwanted hair growth, small red bumps on the skin||
7052|062|S|(folliculitis).||
7052|063|S|   Rarely, it is possible this medication will be absorbed from||
7052|064|S|the skin into the bloodstream. This can lead to side effects of||
7052|065|S|too much corticosteroid. These side effects are more likely in||
7052|066|S|children, and in people who use this medication for a long time||
7052|067|S|or over large areas of the skin. Tell your doctor right away if||
7052|068|S|any of the following side effects occur: unusual/extreme||
7052|069|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
7052|070|S|thirst/urination, vision problems.||
7052|071|S|   A very serious allergic reaction to this drug is rare.||
7052|072|S|However, get medical help right away if you notice any symptoms||
7052|073|S|of a serious allergic reaction, including: rash, itching/swelling||
7052|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7052|075|S|breathing.||
7052|076|S|   This is not a complete list of possible side effects. If you||
7052|077|S|notice other effects not listed above, contact your doctor or||
7052|078|S|pharmacist.||
7052|079|S|   In the US -||
7052|080|S|   Call your doctor for medical advice about side effects. You||
7052|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7052|082|S|www.fda.gov/medwatch.||
7052|083|S|   In Canada - Call your doctor for medical advice about side||
7052|084|S|effects. You may report side effects to Health Canada at||
7052|085|S|1-866-234-2345.||
7052|086|B|||
7052|087|P|PRECAUTIONS:  Before using nystatin with triamcinolone, tell your||
7052|088|P|doctor or pharmacist if you are allergic to it; or to other||
7052|089|P|corticosteroids (such as hydrocortisone, prednisone); or if you||
7052|090|P|have any other allergies. This product may contain inactive||
7052|091|P|ingredients, which can cause allergic reactions or other||
7052|092|P|problems. Talk to your pharmacist for more details.||
7052|093|P|   Before using this medication, tell your doctor or pharmacist||
7052|094|P|your medical history.||
7052|095|P|   Rarely, using corticosteroid medications for a long time or||
7052|096|P|over large areas of skin can make it more difficult for your body||
7052|097|P|to respond to physical stress. Before having surgery or emergency||
7052|098|P|treatment, or if you get a serious illness/injury, tell your||
7052|099|P|doctor or dentist that you are using this medication or have used||
7052|100|P|this medication within the past few months.||
7052|101|P|   Though it is unlikely, this medication may temporarily slow||
7052|102|P|down a child's growth if used for a long time. See the doctor||
7052|103|P|regularly so your child's height can be checked.||
7052|104|P|   During pregnancy, this medication should be used only when||
7052|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
7052|106|P|   It is unknown if this drug passes into breast milk. Consult||
7052|107|P|your doctor before breastfeeding.||
7052|108|B|||
7052|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7052|110|I|medications work or increase your risk for serious side effects.||
7052|111|I|This document does not contain all possible drug interactions.||
7052|112|I|Keep a list of all the products you use (including||
7052|113|I|prescription/nonprescription drugs and herbal products) and share||
7052|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
7052|115|I|the dosage of any medicines without your doctor's approval.||
7052|116|B|||
7052|117|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7052|118|O|has overdosed and has serious symptoms such as passing out or||
7052|119|O|trouble breathing, call 911. Otherwise, call a poison control||
7052|120|O|center right away. US residents can call 1-800-222-1222. Canada||
7052|121|O|residents can call 1-844-764-7669.||
7052|122|B|||
7052|123|N|NOTES:  Do not share this medication with others.||
7052|124|N|   This medication has been prescribed for your current condition||
7052|125|N|only. Do not use it later for another infection unless your||
7052|126|N|doctor tells you to.||
7052|127|N|   Lab and/or medical tests (such as adrenal gland function) may||
7052|128|N|be done while you are using this medication, especially if you||
7052|129|N|use this drug for an extended period of time or apply it over||
7052|130|N|large areas of the body. Keep all medical and lab appointments.||
7052|131|N|Consult your doctor for more details.||
7052|132|B|||
7052|133|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7052|134|D|If it is near the time of the next dose, skip the missed dose.||
7052|135|D|Use your next dose at the regular time. Do not double the dose to||
7052|136|D|catch up.||
7052|137|B|||
7052|138|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
7052|139|R|medications away from children and pets.||
7052|140|R|   Do not flush medications down the toilet or pour them into a||
7052|141|R|drain unless instructed to do so. Properly discard this product||
7052|142|R|when it is expired or no longer needed. Consult your pharmacist||
7052|143|R|or local waste disposal company.||
7052|144|B|||
7052|145|A|Information last revised November 2024.||
7052|146|A|Copyright(c) 2025 First Databank, Inc.||
7052|147|B|||
7053|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7053|002|Z|does NOT have all possible information about this product. This||
7053|003|Z|information does not assure that this product is safe, effective,||
7053|004|Z|or appropriate for you. This information is not individual||
7053|005|Z|medical advice and does not substitute for the advice of your||
7053|006|Z|health care professional. Always ask your health care||
7053|007|Z|professional for complete information about this product and your||
7053|008|Z|specific health needs.||
7053|009|B|||
7053|010|T|PROMETHAZINE SUPPOSITORY - RECTAL||
7053|011|F|(proe-METH-a-zeen)||
7053|012|B|||
7053|013|C|COMMON BRAND NAME(S): Phenergan, Promethegan||
7053|014|B|||
7053|015|W|WARNING:  Promethazine should not be used by children younger||
7053|016|W|than 2 years because it may cause serious (possibly fatal)||
7053|017|W|slow/shallow breathing. When this medication is used by children||
7053|018|W|2 years and older, the lowest effective dosage should be used,||
7053|019|W|and other drugs that affect breathing should be avoided. Get||
7053|020|W|medical help right away if slow/shallow breathing occurs.||
7053|021|W|   In children, drugs for nausea should only be used in cases of||
7053|022|W|prolonged vomiting of a known cause. Avoid use of promethazine in||
7053|023|W|children with liver disease (including possible Reye's syndrome).||
7053|024|B|||
7053|025|U|USES:  See also Warning section.||
7053|026|U|   Promethazine is used to prevent and treat nausea and vomiting||
7053|027|U|related to certain conditions (such as motion sickness, or||
7053|028|U|before/after surgery). It is also used to treat allergy symptoms||
7053|029|U|such as rash, itching, and runny nose. It may be used to help you||
7053|030|U|feel sleepy/relaxed before and after surgery or to help certain||
7053|031|U|opioid pain relievers (such as meperidine) work better. The||
7053|032|U|suppository form is used when medications cannot be taken by||
7053|033|U|mouth.||
7053|034|U|   Promethazine is an antihistamine and works by blocking a||
7053|035|U|certain natural substance (histamine) that your body makes during||
7053|036|U|an allergic reaction. Its other effects (such as anti-nausea,||
7053|037|U|calming, pain relief) may work by affecting other natural||
7053|038|U|substances (such as acetylcholine) and by acting directly on||
7053|039|U|certain parts of the brain.||
7053|040|B|||
7053|041|H|HOW TO USE:  Unwrap and insert one suppository rectally as||
7053|042|H|directed by your doctor, usually 2 to 4 times daily. Remain lying||
7053|043|H|down for a few minutes after using this medication, and avoid||
7053|044|H|having a bowel movement for an hour or longer so the drug will be||
7053|045|H|absorbed. The suppository is for rectal use only.||
7053|046|H|   For motion sickness, the first dose of promethazine should be||
7053|047|H|used 30 to 60 minutes before beginning travel. For allergies,||
7053|048|H|this medication may be used once daily at bedtime to avoid being||
7053|049|H|drowsy during the day. When used before surgery, promethazine may||
7053|050|H|be used the night before or just before the procedure and may be||
7053|051|H|continued afterwards as directed.||
7053|052|H|   The dosage is based on your age, medical condition, and||
7053|053|H|response to treatment. Children's dosage may also be based on||
7053|054|H|weight. Do not increase your dose or use this medication more||
7053|055|H|often than directed.||
7053|056|H|   Tell your doctor if your condition does not get better or if||
7053|057|H|it gets worse.||
7053|058|B|||
7053|059|S|SIDE EFFECTS:  Drowsiness, dizziness, constipation, blurred||
7053|060|S|vision, or dry mouth may occur. If any of these effects last or||
7053|061|S|get worse, tell your doctor or pharmacist promptly.||
7053|062|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
7053|063|S|chips, chew (sugarless) gum, drink water, or use a saliva||
7053|064|S|substitute.||
7053|065|S|   Remember that this medication has been prescribed because your||
7053|066|S|doctor has judged that the benefit to you is greater than the||
7053|067|S|risk of side effects. Many people using this medication do not||
7053|068|S|have serious side effects.||
7053|069|S|   Tell your doctor right away if you have any serious side||
7053|070|S|effects, including: nausea/vomiting that doesn't stop, fainting,||
7053|071|S|slow heartbeat, mental/mood changes (such as hallucinations,||
7053|072|S|nervousness, irritability, restlessness, confusion),||
7053|073|S|unusual/uncontrolled movements (such as fixed upward stare, neck||
7053|074|S|twisting, tongue movements), shaking (tremor), difficulty||
7053|075|S|urinating, easy bleeding/bruising, signs of infection (such as||
7053|076|S|sore throat that doesn't go away, fever, chills), severe||
7053|077|S|stomach/abdominal pain, yellowing eyes/skin.||
7053|078|S|   Get medical help right away if you have any very serious side||
7053|079|S|effects, including: slow/shallow breathing, seizures.||
7053|080|S|   This medication may rarely cause a very serious condition||
7053|081|S|called neuroleptic malignant syndrome (NMS). Get medical help||
7053|082|S|right away if you have any of the following symptoms: fever,||
7053|083|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
7053|084|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
7053|085|S|signs of kidney problems (such as change in the amount of urine).||
7053|086|S|   A very serious allergic reaction to this drug is rare.||
7053|087|S|However, get medical help right away if you notice any symptoms||
7053|088|S|of a serious allergic reaction, including: rash, itching/swelling||
7053|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7053|090|S|breathing.||
7053|091|S|   This is not a complete list of possible side effects. If you||
7053|092|S|notice other effects not listed above, contact your doctor or||
7053|093|S|pharmacist.||
7053|094|S|   In the US -||
7053|095|S|   Call your doctor for medical advice about side effects. You||
7053|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7053|097|S|www.fda.gov/medwatch.||
7053|098|S|   In Canada - Call your doctor for medical advice about side||
7053|099|S|effects. You may report side effects to Health Canada at||
7053|100|S|1-866-234-2345.||
7053|101|B|||
7053|102|P|PRECAUTIONS:  See also Warning section.||
7053|103|P|   Before using promethazine, tell your doctor or pharmacist if||
7053|104|P|you are allergic to it; or to any other phenothiazines (such as||
7053|105|P|prochlorperazine); or if you have any other allergies. This||
7053|106|P|product may contain inactive ingredients, which can cause||
7053|107|P|allergic reactions or other problems. Talk to your pharmacist for||
7053|108|P|more details.||
7053|109|P|   Before using this medication, tell your doctor or pharmacist||
7053|110|P|your medical history, especially of: breathing problems (such as||
7053|111|P|asthma, chronic obstructive pulmonary disease-COPD, sleep apnea),||
7053|112|P|blood/immune system problems (such as bone marrow depression),||
7053|113|P|high pressure in the eye (glaucoma), heart disease (such as||
7053|114|P|irregular heartbeat), high blood pressure, liver disease, certain||
7053|115|P|brain disorders (such as neuroleptic malignant syndrome, Reye's||
7053|116|P|syndrome, seizures), stomach/intestine problems (such as||
7053|117|P|blockage, ulcer), overactive thyroid (hyperthyroidism),||
7053|118|P|difficulty urinating (for example, due to enlarged prostate).||
7053|119|P|   This drug may make you dizzy or drowsy or blur your vision.||
7053|120|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7053|121|P|drowsy. Do not drive, use machinery, or do anything that needs||
7053|122|P|alertness or clear vision until you can do it safely. Avoid||
7053|123|P|alcoholic beverages. Talk to your doctor if you are using||
7053|124|P|marijuana (cannabis).||
7053|125|P|   Before having surgery, tell your doctor or dentist about all||
7053|126|P|the products you use (including prescription drugs,||
7053|127|P|nonprescription drugs, and herbal products).||
7053|128|P|   This medication may make you more sensitive to the sun. Limit||
7053|129|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
7053|130|P|sunscreen and wear protective clothing when outdoors. Tell your||
7053|131|P|doctor right away if you get sunburned or have skin||
7053|132|P|blisters/redness.||
7053|133|P|   This medication may make you sweat less, making you more||
7053|134|P|likely to get heat stroke. Avoid doing things that may cause you||
7053|135|P|to overheat, such as hard work or exercise in hot weather, or||
7053|136|P|using hot tubs. When the weather is hot, drink a lot of fluids||
7053|137|P|and dress lightly. If you overheat, quickly look for a place to||
7053|138|P|cool down and rest. Get medical help right away if you have a||
7053|139|P|fever that does not go away, mental/mood changes, headache, or||
7053|140|P|dizziness.||
7053|141|P|   Children may be more sensitive to the side effects of this||
7053|142|P|drug, especially slowed breathing and uncontrolled movements (see||
7053|143|P|also Warning section). This drug can often cause excitement in||
7053|144|P|young children instead of drowsiness. Special care should be||
7053|145|P|taken when using this medication in children who have lost a lot||
7053|146|P|of fluid (dehydration), those who have a family history of sudden||
7053|147|P|infant death syndrome (SIDS), and those who are hard to wake up||
7053|148|P|from sleep.||
7053|149|P|   Older adults may be more sensitive to the side effects of this||
7053|150|P|drug, especially drowsiness, confusion, constipation, or trouble||
7053|151|P|urinating. Drowsiness and confusion can increase the risk of||
7053|152|P|falling.||
7053|153|P|   During pregnancy, this medication should be used only when||
7053|154|P|clearly needed. Discuss the risks and benefits with your doctor.||
7053|155|P|   It is unknown if promethazine passes into breast milk. Consult||
7053|156|P|your doctor before breastfeeding.||
7053|157|B|||
7053|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7053|159|I|medications work or increase your risk for serious side effects.||
7053|160|I|This document does not contain all possible drug interactions.||
7053|161|I|Keep a list of all the products you use (including||
7053|162|I|prescription/nonprescription drugs and herbal products) and share||
7053|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
7053|164|I|the dosage of any medicines without your doctor's approval.||
7053|165|I|   Some products that may interact with this drug include:||
7053|166|I|antihistamines applied to the skin (such as diphenhydramine||
7053|167|I|cream, ointment, spray), metoclopramide.||
7053|168|I|   The risk of serious side effects (such as slow/shallow||
7053|169|I|breathing, severe drowsiness/dizziness) may be increased if this||
7053|170|I|medication is used with other products that may also cause||
7053|171|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
7053|172|I|if you are taking other products such as opioid pain or cough||
7053|173|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7053|174|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
7053|175|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7053|176|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
7053|177|I|diphenhydramine).||
7053|178|I|   Check the labels on all your medicines (such as allergy or||
7053|179|I|cough-and-cold products) because they may contain ingredients||
7053|180|I|that cause drowsiness. Ask your pharmacist about using those||
7053|181|I|products safely.||
7053|182|I|   This medication may interfere with certain lab tests (such as||
7053|183|I|some pregnancy tests, glucose tolerance test, allergy skin||
7053|184|I|testing), possibly causing false test results. Make sure lab||
7053|185|I|personnel and all your doctors know you use this drug.||
7053|186|B|||
7053|187|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7053|188|O|has overdosed and has serious symptoms such as passing out or||
7053|189|O|trouble breathing, call 911. Otherwise, call a poison control||
7053|190|O|center right away. US residents can call 1-800-222-1222. Canada||
7053|191|O|residents can call 1-844-764-7669. Symptoms of overdose may||
7053|192|O|include: severe drowsiness/dizziness, fainting, slow/shallow||
7053|193|O|breathing, seizures, muscle stiffness/twitching, widened pupils.||
7053|194|O|In children, mental/mood changes (such as restlessness,||
7053|195|O|irritability, hallucinations) may occur before drowsiness.||
7053|196|B|||
7053|197|N|NOTES:  Do not share this medication with others.||
7053|198|B|||
7053|199|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7053|200|D|If it is near the time of the next dose, skip the missed dose.||
7053|201|D|Use your next dose at the regular time. Do not double the dose to||
7053|202|D|catch up.||
7053|203|B|||
7053|204|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
7053|205|R|medications away from children and pets.||
7053|206|R|   Do not flush medications down the toilet or pour them into a||
7053|207|R|drain unless instructed to do so. Properly discard this product||
7053|208|R|when it is expired or no longer needed. Consult your pharmacist||
7053|209|R|or local waste disposal company.||
7053|210|B|||
7053|211|A|Information last revised May 2025.||
7053|212|A|Copyright(c) 2025 First Databank, Inc.||
7053|213|B|||
7055|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7055|002|Z|does NOT have all possible information about this product. This||
7055|003|Z|information does not assure that this product is safe, effective,||
7055|004|Z|or appropriate for you. This information is not individual||
7055|005|Z|medical advice and does not substitute for the advice of your||
7055|006|Z|health care professional. Always ask your health care||
7055|007|Z|professional for complete information about this product and your||
7055|008|Z|specific health needs.||
7055|009|B|||
7055|010|T|METRONIDAZOLE - VAGINAL||
7055|011|F|(MET-roe-NID-a-zole)||
7055|012|B|||
7055|013|C|COMMON BRAND NAME(S): Metrogel||
7055|014|B|||
7055|015|U|USES:  This medication is used to treat certain types of||
7055|016|U|bacterial infections in the vagina. Metronidazole is an||
7055|017|U|antibiotic that works by stopping the growth of bacteria.||
7055|018|B|||
7055|019|H|HOW TO USE:  Read the Instructions for Use that come with this||
7055|020|H|product before you start using this medication. If you have any||
7055|021|H|questions, ask your doctor or pharmacist.||
7055|022|H|   This product is for vaginal use only. Use as directed by your||
7055|023|H|doctor, usually once or twice daily. If using once daily, use the||
7055|024|H|medication at bedtime. Wash your hands before and after use. Fill||
7055|025|H|the applicator with the medication. Insert the applicator high||
7055|026|H|into the vagina and press the plunger to release the medication.||
7055|027|H|   Avoid getting this medication in your eyes. If it gets into||
7055|028|H|your eyes, rinse them with cool water. Call your doctor if eye||
7055|029|H|irritation lasts.||
7055|030|H|   Continue to use this medication until the full prescribed||
7055|031|H|amount is finished, even if symptoms disappear after a few days.||
7055|032|H|Stopping the medication too early may result in a return of the||
7055|033|H|infection.||
7055|034|H|   Tell your doctor if your condition does not get better after||
7055|035|H|several days or if it gets worse.||
7055|036|B|||
7055|037|S|SIDE EFFECTS:  Stomach discomfort, headache, or dizziness may||
7055|038|S|occur. If any of these effects last or get worse, tell your||
7055|039|S|doctor or pharmacist promptly.||
7055|040|S|   Vaginal discomfort/itching/discharge may occur or worsen.||
7055|041|S|These symptoms may be due to a new vaginal infection (such as a||
7055|042|S|yeast/fungal infection). Contact your doctor if you notice a||
7055|043|S|change in vaginal discharge or other new vaginal symptoms.||
7055|044|S|   Remember that this medication has been prescribed because your||
7055|045|S|doctor has judged that the benefit to you is greater than the||
7055|046|S|risk of side effects. Many people using this medication do not||
7055|047|S|have serious side effects.||
7055|048|S|   Stop using this medication and get medical help right away if||
7055|049|S|you have any very serious side effects, including:||
7055|050|S|numbness/tingling of the hands/feet, seizures.||
7055|051|S|   A very serious allergic reaction to this drug is rare.||
7055|052|S|However, get medical help right away if you notice any symptoms||
7055|053|S|of a serious allergic reaction, including: fever that doesn't go||
7055|054|S|away, new or worsening lymph node swelling, rash,||
7055|055|S|itching/swelling (especially of the face/tongue/throat), severe||
7055|056|S|dizziness, trouble breathing.||
7055|057|S|   This is not a complete list of possible side effects. If you||
7055|058|S|notice other effects not listed above, contact your doctor or||
7055|059|S|pharmacist.||
7055|060|S|   In the US -||
7055|061|S|   Call your doctor for medical advice about side effects. You||
7055|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7055|063|S|www.fda.gov/medwatch.||
7055|064|S|   In Canada - Call your doctor for medical advice about side||
7055|065|S|effects. You may report side effects to Health Canada at||
7055|066|S|1-866-234-2345.||
7055|067|B|||
7055|068|P|PRECAUTIONS:  Before using metronidazole, tell your doctor or||
7055|069|P|pharmacist if you are allergic to it; or to other nitroimidazole||
7055|070|P|antibiotics (such as tinidazole); or if you have any other||
7055|071|P|allergies. This product may contain inactive ingredients (such as||
7055|072|P|paraben preservatives), which can cause allergic reactions or||
7055|073|P|other problems. Talk to your pharmacist for more details.||
7055|074|P|   Before using this medication, tell your doctor or pharmacist||
7055|075|P|your medical history, especially of: nervous system disorders||
7055|076|P|(such as seizures, numbness/tingling of the hands/feet), liver||
7055|077|P|disease.||
7055|078|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7055|079|P|can make you more dizzy. Do not drive, use machinery, or do||
7055|080|P|anything that needs alertness until you can do it safely. Talk to||
7055|081|P|your doctor if you are using marijuana (cannabis).||
7055|082|P|   Do not drink alcohol while using this medication and for at||
7055|083|P|least 24 hours after stopping this medication. Drinking alcohol||
7055|084|P|while using this medication may cause stomach cramps, flushing,||
7055|085|P|nausea, vomiting, and headache.||
7055|086|P|   Do not have vaginal sex or use tampons or douches while using||
7055|087|P|this medication.||
7055|088|P|   During pregnancy, this medication should be used only when||
7055|089|P|clearly needed. Antibiotics taken by mouth have been used to||
7055|090|P|treat vaginal infections during pregnancy, especially high-risk||
7055|091|P|pregnancies (for example, if there is a risk of early||
7055|092|P|childbirth). Consult your doctor for more details and to discuss||
7055|093|P|the risks and benefits.||
7055|094|P|   It is unknown if this medication passes into breast milk.||
7055|095|P|Consult your doctor before breastfeeding.||
7055|096|B|||
7055|097|I|DRUG INTERACTIONS:  See also Precautions section.||
7055|098|I|   Drug interactions may change how your medications work or||
7055|099|I|increase your risk for serious side effects. This document does||
7055|100|I|not contain all possible drug interactions. Keep a list of all||
7055|101|I|the products you use (including prescription/nonprescription||
7055|102|I|drugs and herbal products) and share it with your doctor and||
7055|103|I|pharmacist. Do not start, stop, or change the dosage of any||
7055|104|I|medicines without your doctor's approval.||
7055|105|I|   Do not use this medication if you have taken disulfiram within||
7055|106|I|the last 2 weeks.||
7055|107|I|   Do not take products containing alcohol or propylene glycol||
7055|108|I|while using this medication and for at least 24 hours after||
7055|109|I|stopping this medication. Ask your pharmacist for more details.||
7055|110|I|   This medication may interfere with certain lab tests, possibly||
7055|111|I|causing false test results. Make sure lab personnel and all your||
7055|112|I|doctors know you use this drug.||
7055|113|B|||
7055|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7055|115|O|has overdosed and has serious symptoms such as passing out or||
7055|116|O|trouble breathing, call 911. Otherwise, call a poison control||
7055|117|O|center right away. US residents can call 1-800-222-1222. Canada||
7055|118|O|residents can call 1-844-764-7669.||
7055|119|B|||
7055|120|N|NOTES:  Do not share this medication with others.||
7055|121|N|   This medication has been prescribed for your current condition||
7055|122|N|only. Do not use it later for another infection unless your||
7055|123|N|doctor tells you to.||
7055|124|B|||
7055|125|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7055|126|D|If it is near the time of the next dose, skip the missed dose.||
7055|127|D|Use your next dose at the regular time. Do not double the dose to||
7055|128|D|catch up.||
7055|129|B|||
7055|130|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
7055|131|R|medications away from children and pets.||
7055|132|R|   Do not flush medications down the toilet or pour them into a||
7055|133|R|drain unless instructed to do so. Properly discard this product||
7055|134|R|when it is expired or no longer needed. Consult your pharmacist||
7055|135|R|or local waste disposal company.||
7055|136|B|||
7055|137|A|Information last revised November 2024.||
7055|138|A|Copyright(c) 2025 First Databank, Inc.||
7055|139|B|||
7058|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7058|002|Z|does NOT have all possible information about this product. This||
7058|003|Z|information does not assure that this product is safe, effective,||
7058|004|Z|or appropriate for you. This information is not individual||
7058|005|Z|medical advice and does not substitute for the advice of your||
7058|006|Z|health care professional. Always ask your health care||
7058|007|Z|professional for complete information about this product and your||
7058|008|Z|specific health needs.||
7058|009|B|||
7058|010|T|POTASSIUM EXTENDED-RELEASE DISPERSIBLE TABLET - ORAL||
7058|011|F|(poe-TAS-ee-um)||
7058|012|B|||
7058|013|C|COMMON BRAND NAME(S): K-Dur, Klor-Con M||
7058|014|B|||
7058|015|U|USES:  This medication is a mineral supplement used to treat or||
7058|016|U|prevent low amounts of potassium in the blood. A normal level of||
7058|017|U|potassium in the blood is important. Potassium helps your cells,||
7058|018|U|kidneys, heart, muscles, and nerves work properly. Most people||
7058|019|U|get enough potassium by eating a well-balanced diet. Some||
7058|020|U|conditions that can lower your body's potassium level include||
7058|021|U|severe prolonged diarrhea and vomiting, hormone problems such as||
7058|022|U|hyperaldosteronism, or treatment with "water pills"/diuretics.||
7058|023|B|||
7058|024|H|HOW TO USE:  Take this medication by mouth as directed by your||
7058|025|H|doctor. To prevent stomach upset, take each dose with a meal and||
7058|026|H|a full glass of water (8 ounces/240 milliliters) unless your||
7058|027|H|doctor directs you otherwise. Do not lie down for at least 10||
7058|028|H|minutes after taking this medication.||
7058|029|H|   Do not crush, chew, or suck on the tablets. Doing so can||
7058|030|H|release all of the drug at once, increasing the risk of side||
7058|031|H|effects.||
7058|032|H|   If you have trouble swallowing the tablets, you may break the||
7058|033|H|tablet in half and take one half with a glass of water; then take||
7058|034|H|the other half tablet with another glass of water. Another choice||
7058|035|H|is to dissolve the tablet in a half glass of water (4 ounces/120||
7058|036|H|milliliters) before taking it. After the tablet dissolves (about||
7058|037|H|2 minutes), stir the mixture for 30 seconds then drink all the||
7058|038|H|liquid. Add one more ounce (30 milliliters) of water to the||
7058|039|H|glass, swirl, and drink. Repeat one more time to make sure you||
7058|040|H|are getting all of the drug. Use only water for mixing, and do||
7058|041|H|not prepare the mixture ahead of time. Ask your doctor or||
7058|042|H|pharmacist if you have any questions.||
7058|043|H|   Take this medication regularly to get the most benefit from||
7058|044|H|it. To help you remember, take it at the same time(s) each day.||
7058|045|H|The dosage is based on your medical condition and response to||
7058|046|H|treatment. Do not increase your dose or take it more often than||
7058|047|H|prescribed. Do not take more than 20 milliequivalents per dose.||
7058|048|H|   Tell your doctor if your condition does not get better or if||
7058|049|H|you have symptoms of low potassium in the blood (such as||
7058|050|H|irregular heartbeat, muscle weakness/cramps).||
7058|051|B|||
7058|052|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, gas, or diarrhea||
7058|053|S|may occur. If any of these effects last or get worse, tell your||
7058|054|S|doctor or pharmacist promptly.||
7058|055|S|   Remember that this medication has been prescribed because your||
7058|056|S|doctor has judged that the benefit to you is greater than the||
7058|057|S|risk of side effects. Many people using this medication do not||
7058|058|S|have serious side effects.||
7058|059|S|   Tell your doctor right away if you have any serious side||
7058|060|S|effects, including: difficult/painful swallowing, feeling as if||
7058|061|S|the tablet is stuck in your throat.||
7058|062|S|   Get medical help right away if you have any very serious side||
7058|063|S|effects, including: vomit that looks like coffee grounds,||
7058|064|S|stomach/abdominal pain, black/tarry stools.||
7058|065|S|   A very serious allergic reaction to this drug is rare.||
7058|066|S|However, get medical help right away if you notice any symptoms||
7058|067|S|of a serious allergic reaction, including: rash, itching/swelling||
7058|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7058|069|S|breathing.||
7058|070|S|   This is not a complete list of possible side effects. If you||
7058|071|S|notice other effects not listed above, contact your doctor or||
7058|072|S|pharmacist.||
7058|073|S|   In the US -||
7058|074|S|   Call your doctor for medical advice about side effects. You||
7058|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7058|076|S|www.fda.gov/medwatch.||
7058|077|S|   In Canada - Call your doctor for medical advice about side||
7058|078|S|effects. You may report side effects to Health Canada at||
7058|079|S|1-866-234-2345.||
7058|080|B|||
7058|081|P|PRECAUTIONS:  Before taking potassium, tell your doctor or||
7058|082|P|pharmacist if you have any allergies. This product may contain||
7058|083|P|inactive ingredients, which can cause allergic reactions or other||
7058|084|P|problems. Talk to your pharmacist for more details.||
7058|085|P|   Before using this medication, tell your doctor or pharmacist||
7058|086|P|your medical history, especially of: heart problems, kidney||
7058|087|P|problems, high levels of potassium in the blood.||
7058|088|P|   Due to rare reports of stomach/intestinal ulcers and bleeding||
7058|089|P|with sustained-release potassium products, taking a liquid form||
7058|090|P|of potassium is preferred. Tell your doctor or pharmacist if you||
7058|091|P|have throat/stomach/intestinal problems such as blockage,||
7058|092|P|narrowing, or ulcers.||
7058|093|P|   Before having surgery, tell your doctor or dentist about all||
7058|094|P|the products you use (including prescription drugs,||
7058|095|P|nonprescription drugs, and herbal products).||
7058|096|P|   Before using other potassium supplements or salt substitutes||
7058|097|P|that contain potassium, consult your doctor or pharmacist. Too||
7058|098|P|much potassium may cause serious side effects. (See also Overdose||
7058|099|P|section.)||
7058|100|P|   During pregnancy, this medication should be used only when||
7058|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
7058|102|P|   Potassium passes into breast milk. Consult your doctor before||
7058|103|P|breastfeeding.||
7058|104|B|||
7058|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7058|106|I|medications work or increase your risk for serious side effects.||
7058|107|I|This document does not contain all possible drug interactions.||
7058|108|I|Keep a list of all the products you use (including||
7058|109|I|prescription/nonprescription drugs and herbal products) and share||
7058|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
7058|111|I|the dosage of any medicines without your doctor's approval.||
7058|112|I|   Tell your doctor or pharmacist if you are regularly taking||
7058|113|I|other medications that can also raise your potassium level.||
7058|114|I|Examples include drospirenone, eplerenone, ACE inhibitors (such||
7058|115|I|as enalapril, lisinopril), angiotensin receptor blockers (such as||
7058|116|I|losartan, valsartan), potassium-sparing "water pills"/diuretics||
7058|117|I|(such as spironolactone, triamterene), among others.||
7058|118|I|   Also, tell your doctor or pharmacist if you take medications||
7058|119|I|that can slow down the movement of potassium in your stomach or||
7058|120|I|intestines, possibly increasing the risk of side effects (such as||
7058|121|I|ulcers). Examples include atropine, scopolamine, some||
7058|122|I|antihistamines such as diphenhydramine, antispasmodic drugs such||
7058|123|I|as dicyclomine/hyoscyamine, bladder control drugs such as||
7058|124|I|oxybutynin/tolterodine, certain drugs for Parkinson's disease||
7058|125|I|such as benztropine/trihexyphenidyl, among others.||
7058|126|B|||
7058|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7058|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7058|129|O|poison control center right away. US residents can call||
7058|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7058|131|O|Symptoms of overdose may include irregular heartbeat, muscle||
7058|132|O|weakness, confusion.||
7058|133|B|||
7058|134|N|NOTES:  Do not share this medication with others.||
7058|135|N|   Lab and/or medical tests (such as potassium blood level,||
7058|136|N|kidney function) should be done while you are taking this||
7058|137|N|medication. Keep all medical and lab appointments. Consult your||
7058|138|N|doctor for more details.||
7058|139|N|   Eat a well-balanced diet. Foods high in potassium include||
7058|140|N|bananas, oranges, cantaloupe, raisins, dates, prunes, avocados,||
7058|141|N|apricots, beans, broccoli, spinach, potatoes, lentils, chicken,||
7058|142|N|turkey, beef, and yogurt. Consult your doctor or dietician for||
7058|143|N|recommended foods.||
7058|144|B|||
7058|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7058|146|D|remember. If it is near the time of the next dose, skip the||
7058|147|D|missed dose. Take your next dose at the regular time. Do not||
7058|148|D|double the dose to catch up.||
7058|149|B|||
7058|150|R|STORAGE:  Store at room temperature away from light and moisture.||
7058|151|R|Do not store in the bathroom. Keep all medications away from||
7058|152|R|children and pets.||
7058|153|R|   Do not flush medications down the toilet or pour them into a||
7058|154|R|drain unless instructed to do so. Properly discard this product||
7058|155|R|when it is expired or no longer needed. Consult your pharmacist||
7058|156|R|or local waste disposal company.||
7058|157|B|||
7058|158|A|Information last revised November 2024.||
7058|159|A|Copyright(c) 2025 First Databank, Inc.||
7058|160|B|||
7059|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7059|002|Z|does NOT have all possible information about this product. This||
7059|003|Z|information does not assure that this product is safe, effective,||
7059|004|Z|or appropriate for you. This information is not individual||
7059|005|Z|medical advice and does not substitute for the advice of your||
7059|006|Z|health care professional. Always ask your health care||
7059|007|Z|professional for complete information about this product and your||
7059|008|Z|specific health needs.||
7059|009|B|||
7059|010|T|NITROFURANTOIN SUSPENSION - ORAL||
7059|011|F|(NYE-trow-fyour-AN-toe-in)||
7059|012|B|||
7059|013|C|COMMON BRAND NAME(S): Furadantin||
7059|014|B|||
7059|015|U|USES:  Nitrofurantoin is an antibiotic used to treat or prevent||
7059|016|U|certain bladder infections. It works by stopping the growth of||
7059|017|U|bacteria.||
7059|018|U|   This antibiotic treats only bacterial infections. It will not||
7059|019|U|work for viral infections (such as common cold, flu). Using any||
7059|020|U|antibiotic when it is not needed can cause it to not work for||
7059|021|U|future infections.||
7059|022|U|   This medication should not be used in infants younger than 1||
7059|023|U|month old (see also Precautions section). This drug should not be||
7059|024|U|used to treat infections outside the bladder (including kidney||
7059|025|U|infections such as pyelonephritis or perinephric abscesses).||
7059|026|B|||
7059|027|H|HOW TO USE:  Shake the bottle well before each dose. Take this||
7059|028|H|medication by mouth with food as directed by your doctor. This||
7059|029|H|medication is usually taken 4 times daily to treat an infection||
7059|030|H|or once daily at bedtime to prevent infections. Carefully measure||
7059|031|H|the dose using a special measuring device/spoon. Do not use a||
7059|032|H|household spoon because you may not get the correct dose.||
7059|033|H|   The dosage and length of treatment is based on your medical||
7059|034|H|condition and response to treatment. Children's dosage is also||
7059|035|H|based on weight.||
7059|036|H|   This drug may be mixed into water, juice, milk, or formula to||
7059|037|H|improve the taste. Rinse the mouth after each dose to help||
7059|038|H|prevent temporary staining of the teeth.||
7059|039|H|   Do not use magnesium trisilicate-containing antacids while||
7059|040|H|taking this medication. These antacids can bind with||
7059|041|H|nitrofurantoin, preventing its full absorption into your system.||
7059|042|H|   For the best effect, take this antibiotic at evenly spaced||
7059|043|H|times. To help you remember, take this medication at the same||
7059|044|H|time(s) every day.||
7059|045|H|   When taking this medication to prevent infection, take it||
7059|046|H|exactly as directed by your doctor. Do not skip doses or stop||
7059|047|H|taking it without your doctor's approval. Tell your doctor if you||
7059|048|H|notice signs of a bladder infection (such as pain while you are||
7059|049|H|urinating).||
7059|050|H|   If you are taking this medication to treat an infection,||
7059|051|H|continue to take this medication until the full prescribed amount||
7059|052|H|is finished, even if symptoms disappear after a few days.||
7059|053|H|Stopping the medication too early may result in a return of the||
7059|054|H|infection.||
7059|055|H|   Tell your doctor if your condition lasts or gets worse.||
7059|056|B|||
7059|057|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, headache, or||
7059|058|S|diarrhea may occur. Take this medication with food to help||
7059|059|S|minimize nausea. If any of these effects last or get worse, tell||
7059|060|S|your doctor or pharmacist promptly.||
7059|061|S|   Remember that this medication has been prescribed because your||
7059|062|S|doctor has judged that the benefit to you is greater than the||
7059|063|S|risk of side effects. Many people using this medication do not||
7059|064|S|have serious side effects.||
7059|065|S|   This medication may cause your urine to turn dark yellow or||
7059|066|S|brown in color. This is usually a harmless, temporary effect and||
7059|067|S|will disappear when the medication is stopped. However, dark||
7059|068|S|brown urine can also be a sign of rare side effects (liver||
7059|069|S|problems or anemia). Get medical help right away if you notice||
7059|070|S|dark urine along with any of the following symptoms:||
7059|071|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
7059|072|S|yellowing eyes/skin, tiredness, fast/pounding heartbeat.||
7059|073|S|   Tell your doctor right away if you have any serious side||
7059|074|S|effects, including: headaches that are severe or don't go away,||
7059|075|S|eye pain, vision changes, mental/mood changes, new signs of||
7059|076|S|infection (such as sore throat that doesn't go away, fever,||
7059|077|S|chills), easy bruising/bleeding.||
7059|078|S|   Get medical help right away if you have any very serious side||
7059|079|S|effects, including: numbness/tingling of the hands/feet, unusual||
7059|080|S|muscle weakness.||
7059|081|S|   This medication may rarely cause very serious (possibly fatal)||
7059|082|S|lung problems. Lung problems may occur within the first month of||
7059|083|S|treatment or after long-term use of nitrofurantoin (generally for||
7059|084|S|6 months or longer). Get medical help right away if you develop||
7059|085|S|symptoms of lung problems, including: cough that doesn't go away,||
7059|086|S|chest pain, shortness of breath/trouble breathing, joint/muscle||
7059|087|S|pain, bluish/purplish skin.||
7059|088|S|   This medication may rarely cause a severe intestinal condition||
7059|089|S|due to a bacteria called C. difficile. This condition may occur||
7059|090|S|during treatment or weeks to months after treatment has stopped.||
7059|091|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7059|092|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7059|093|S|stool.||
7059|094|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7059|095|S|products because they may make symptoms worse.||
7059|096|S|   Use of nitrofurantoin for prolonged or repeated periods may||
7059|097|S|result in oral thrush or a new vaginal yeast infection. Contact||
7059|098|S|your doctor if you notice white patches in your mouth, a change||
7059|099|S|in vaginal discharge, or other new symptoms.||
7059|100|S|   A very serious allergic reaction to this drug is rare.||
7059|101|S|However, get medical help right away if you notice any symptoms||
7059|102|S|of a serious allergic reaction, including: rash, itching/swelling||
7059|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7059|104|S|breathing.||
7059|105|S|   This is not a complete list of possible side effects. If you||
7059|106|S|notice other effects not listed above, contact your doctor or||
7059|107|S|pharmacist.||
7059|108|S|   In the US -||
7059|109|S|   Call your doctor for medical advice about side effects. You||
7059|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7059|111|S|www.fda.gov/medwatch.||
7059|112|S|   In Canada - Call your doctor for medical advice about side||
7059|113|S|effects. You may report side effects to Health Canada at||
7059|114|S|1-866-234-2345.||
7059|115|B|||
7059|116|P|PRECAUTIONS:  Before taking nitrofurantoin, tell your doctor or||
7059|117|P|pharmacist if you are allergic to it; or if you have any other||
7059|118|P|allergies. This product may contain inactive ingredients, which||
7059|119|P|can cause allergic reactions or other problems. Talk to your||
7059|120|P|pharmacist for more details.||
7059|121|P|   Before using this medication, tell your doctor or pharmacist||
7059|122|P|your medical history, especially of: kidney disease, liver||
7059|123|P|disease (including liver problems caused by nitrofurantoin in the||
7059|124|P|past), a certain genetic condition (G-6-PD deficiency), lung||
7059|125|P|disease, numbness/tingling of the arms/legs, vitamin B||
7059|126|P|deficiency, mineral imbalance, blood disorders (such as anemia),||
7059|127|P|diabetes, ongoing weakness due to long-term disease, certain eye||
7059|128|P|disorders (such as optic neuritis).||
7059|129|P|   Older adults may be at a greater risk for side effects while||
7059|130|P|using this drug, especially nerve, liver or lung problems.||
7059|131|P|   Before having surgery, tell your doctor or dentist about all||
7059|132|P|the products you use (including prescription drugs,||
7059|133|P|nonprescription drugs, and herbal products).||
7059|134|P|   Nitrofurantoin may cause live bacterial vaccines (such as||
7059|135|P|typhoid vaccine) to not work well. Tell your health care||
7059|136|P|professional that you are using nitrofurantoin before having any||
7059|137|P|immunizations/vaccinations.||
7059|138|P|   During pregnancy, this medication should be used only when||
7059|139|P|clearly needed. It must not be used if you are near the end of||
7059|140|P|your pregnancy (38-42 weeks) or at the time of labor and||
7059|141|P|delivery. Doing so may cause a certain blood disorder (hemolytic||
7059|142|P|anemia) in your baby. Discuss the risks and benefits with your||
7059|143|P|doctor.||
7059|144|P|   This medication passes into breast milk and may have||
7059|145|P|undesirable effects on nursing infants younger than 1 month old||
7059|146|P|or those with a certain genetic condition (G-6-PD deficiency).||
7059|147|P|Consult your doctor before breastfeeding.||
7059|148|B|||
7059|149|I|DRUG INTERACTIONS:  See also How to Use section.||
7059|150|I|   Drug interactions may change how your medications work or||
7059|151|I|increase your risk for serious side effects. This document does||
7059|152|I|not contain all possible drug interactions. Keep a list of all||
7059|153|I|the products you use (including prescription/nonprescription||
7059|154|I|drugs and herbal products) and share it with your doctor and||
7059|155|I|pharmacist. Do not start, stop, or change the dosage of any||
7059|156|I|medicines without your doctor's approval.||
7059|157|I|   This medication may interfere with certain lab tests (such as||
7059|158|I|certain urine glucose tests), possibly causing false test||
7059|159|I|results. Make sure lab personnel and all your doctors know you||
7059|160|I|use this drug.||
7059|161|B|||
7059|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7059|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7059|164|O|poison control center right away. US residents can call||
7059|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7059|166|B|||
7059|167|N|NOTES:  Do not share this medication with others.||
7059|168|N|   This medication has been prescribed for your current condition||
7059|169|N|only. Do not use it later for another infection unless your||
7059|170|N|doctor tells you to.||
7059|171|N|   Lab and/or medical tests (such as kidney/liver function,||
7059|172|N|complete blood count, bacterial culture) should be done while you||
7059|173|N|are taking this medication. Lung function tests should be done if||
7059|174|N|you are prescribed nitrofurantoin products for extended treatment||
7059|175|N|(several months or more). Keep all medical and lab appointments.||
7059|176|N|Consult your doctor for more details.||
7059|177|B|||
7059|178|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7059|179|D|remember. If it is near the time of the next dose, skip the||
7059|180|D|missed dose. Take your next dose at the regular time. Do not||
7059|181|D|double the dose to catch up.||
7059|182|B|||
7059|183|R|STORAGE:  Store at room temperature away from light. Do not||
7059|184|R|freeze. Once the bottle is opened, this medication expires after||
7059|185|R|30 days. Keep all medications away from children and pets.||
7059|186|R|   Do not flush medications down the toilet or pour them into a||
7059|187|R|drain unless instructed to do so. Properly discard this product||
7059|188|R|when it is expired or no longer needed. Consult your pharmacist||
7059|189|R|or local waste disposal company.||
7059|190|B|||
7059|191|A|Information last revised May 2025.||
7059|192|A|Copyright(c) 2025 First Databank, Inc.||
7059|193|B|||
7061|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7061|002|Z|does NOT have all possible information about this product. This||
7061|003|Z|information does not assure that this product is safe, effective,||
7061|004|Z|or appropriate for you. This information is not individual||
7061|005|Z|medical advice and does not substitute for the advice of your||
7061|006|Z|health care professional. Always ask your health care||
7061|007|Z|professional for complete information about this product and your||
7061|008|Z|specific health needs.||
7061|009|B|||
7061|010|T|METFORMIN - ORAL||
7061|011|F|(met-FOR-min)||
7061|012|B|||
7061|013|C|COMMON BRAND NAME(S): Glucophage||
7061|014|B|||
7061|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
7061|016|W|cause a serious (sometimes fatal) condition called lactic||
7061|017|W|acidosis. Lactic acidosis is more likely if you are an older||
7061|018|W|adult, if you have kidney or liver disease, dehydration, heart||
7061|019|W|failure, heavy alcohol use, if you have surgery, if you have||
7061|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
7061|021|W|you are using certain drugs. For some conditions, your doctor may||
7061|022|W|tell you to stop taking this medication for a short time. Ask||
7061|023|W|your doctor or pharmacist for more details.||
7061|024|W|   Stop taking this medication and get medical help right away if||
7061|025|W|you have any symptoms of lactic acidosis, such as unusual||
7061|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
7061|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
7061|028|W|or stomach pain with nausea/vomiting/diarrhea.||
7061|029|B|||
7061|030|U|USES:  Metformin is used with a proper diet and exercise program||
7061|031|U|and possibly with other medications to control high blood sugar.||
7061|032|U|It is used in patients with type 2 diabetes. Controlling high||
7061|033|U|blood sugar helps prevent kidney damage, blindness, nerve||
7061|034|U|problems, loss of limbs, and sexual function problems. Proper||
7061|035|U|control of diabetes may also lessen your risk of a heart attack||
7061|036|U|or stroke. Metformin works by helping to restore your body's||
7061|037|U|proper response to the insulin you naturally produce. It also||
7061|038|U|decreases the amount of sugar that your liver makes and that your||
7061|039|U|stomach/intestines absorb.||
7061|040|B|||
7061|041|V|OTHER USES:  This section contains uses of this drug that are not||
7061|042|V|listed in the approved professional labeling for the drug but||
7061|043|V|that may be prescribed by your health care professional. Use this||
7061|044|V|drug for a condition that is listed in this section only if it||
7061|045|V|has been so prescribed by your health care professional.||
7061|046|V|   This drug may also be used with lifestyle changes such as diet||
7061|047|V|and exercise to keep people who are at high risk for diabetes||
7061|048|V|from becoming diabetic. It may also be used by women with a||
7061|049|V|certain disease of the ovaries (polycystic ovarian syndrome).||
7061|050|V|Metformin may make menstrual cycles more regular and increase||
7061|051|V|fertility.||
7061|052|B|||
7061|053|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7061|054|H|from your pharmacist before you start taking metformin and each||
7061|055|H|time you get a refill. If you have any questions, consult your||
7061|056|H|doctor or pharmacist.||
7061|057|H|   Take this medication by mouth as directed by your doctor,||
7061|058|H|usually 1 to 3 times a day with meals. Drink plenty of fluids||
7061|059|H|while taking this medication unless otherwise directed by your||
7061|060|H|doctor.||
7061|061|H|   The dosage is based on your medical condition, response to||
7061|062|H|treatment, and other medications you may be taking. Be sure to||
7061|063|H|tell your doctor and pharmacist about all the products you use||
7061|064|H|(including prescription drugs, nonprescription drugs, and herbal||
7061|065|H|products). To reduce your risk of side effects (such as upset||
7061|066|H|stomach), your doctor may direct you to start this medication at||
7061|067|H|a low dose and gradually increase your dose. Follow your doctor's||
7061|068|H|instructions carefully.||
7061|069|H|   Take this medication regularly in order to get the most||
7061|070|H|benefit from it. Remember to use it at the same times each day.||
7061|071|H|   Tell your doctor if your condition does not get better or if||
7061|072|H|it gets worse (your blood sugar is too high or too low).||
7061|073|B|||
7061|074|S|SIDE EFFECTS:  See also Warning section.||
7061|075|S|   Nausea, vomiting, stomach upset, diarrhea, weakness, or a||
7061|076|S|metallic taste in the mouth may occur. If any of these effects||
7061|077|S|last or get worse, tell your doctor or pharmacist promptly. If||
7061|078|S|stomach symptoms return later (after taking the same dose for||
7061|079|S|several days or weeks), tell your doctor right away. Stomach||
7061|080|S|symptoms that occur after the first days of your treatment may be||
7061|081|S|signs of lactic acidosis.||
7061|082|S|   Remember that this medication has been prescribed because your||
7061|083|S|doctor has judged that the benefit to you is greater than the||
7061|084|S|risk of side effects. Many people using this medication do not||
7061|085|S|have serious side effects.||
7061|086|S|   Metformin does not usually cause low blood sugar||
7061|087|S|(hypoglycemia). Low blood sugar may occur if this drug is||
7061|088|S|prescribed with other diabetes medications, or if you do not get||
7061|089|S|enough calories from food, or if you do unusually heavy exercise.||
7061|090|S|Talk with your doctor or pharmacist about whether the dose of||
7061|091|S|your other diabetes medication(s) needs to be lowered. Symptoms||
7061|092|S|of low blood sugar include sudden sweating, shaking, fast||
7061|093|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
7061|094|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
7061|095|S|treat low blood sugar. If you don't have these reliable forms of||
7061|096|S|glucose, rapidly raise your blood sugar by eating a quick source||
7061|097|S|of sugar such as table sugar, honey, or candy, or drink fruit||
7061|098|S|juice or non-diet soda. Tell your doctor right away about the||
7061|099|S|reaction and the use of this product. To help prevent low blood||
7061|100|S|sugar, eat meals on a regular schedule, and do not skip meals.||
7061|101|S|Check with your doctor or pharmacist to find out what you should||
7061|102|S|do if you miss a meal.||
7061|103|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
7061|104|S|thirst/urination. If these symptoms occur, tell your doctor right||
7061|105|S|away. Your doctor may need to adjust your diabetes medication,||
7061|106|S|exercise program, or diet.||
7061|107|S|   Stop taking this medication and tell your doctor right away if||
7061|108|S|this very serious side effect occurs: lactic acidosis (see||
7061|109|S|Warning section).||
7061|110|S|   A very serious allergic reaction to this drug is rare.||
7061|111|S|However, get medical help right away if you notice any symptoms||
7061|112|S|of a serious allergic reaction, including: rash, itching/swelling||
7061|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7061|114|S|breathing.||
7061|115|S|   This is not a complete list of possible side effects. If you||
7061|116|S|notice other effects not listed above, contact your doctor or||
7061|117|S|pharmacist.||
7061|118|S|   In the US -||
7061|119|S|   Call your doctor for medical advice about side effects. You||
7061|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7061|121|S|www.fda.gov/medwatch.||
7061|122|S|   In Canada - Call your doctor for medical advice about side||
7061|123|S|effects. You may report side effects to Health Canada at||
7061|124|S|1-866-234-2345.||
7061|125|B|||
7061|126|P|PRECAUTIONS:  See also Warning section.||
7061|127|P|   Before taking this medication, tell your doctor or pharmacist||
7061|128|P|if you are allergic to metformin; or if you have any other||
7061|129|P|allergies. This product may contain inactive ingredients, which||
7061|130|P|can cause allergic reactions or other problems. Talk to your||
7061|131|P|pharmacist for more details.||
7061|132|P|   Before using this medication, tell your doctor or pharmacist||
7061|133|P|your medical history, especially of: severe breathing problems||
7061|134|P|(such as obstructive lung disease, severe asthma), blood problems||
7061|135|P|(such as anemia, vitamin B12 deficiency), kidney disease, liver||
7061|136|P|disease.||
7061|137|P|   Before having surgery or any X-ray/scanning procedure using||
7061|138|P|iodinated contrast, tell your doctor or dentist about all the||
7061|139|P|products you use (including prescription drugs, nonprescription||
7061|140|P|drugs, and herbal products). You may need to stop this medication||
7061|141|P|for a short time for the surgery/procedure. Ask your doctor or||
7061|142|P|dentist for instructions before your surgery/procedure.||
7061|143|P|   You may experience blurred vision, dizziness, or drowsiness||
7061|144|P|due to extremely low or high blood sugar. Do not drive, use||
7061|145|P|machinery, or do anything that needs alertness or clear vision||
7061|146|P|until you can do it safely.||
7061|147|P|   Limit alcohol while using this medication because it can||
7061|148|P|increase your risk of lactic acidosis and developing low blood||
7061|149|P|sugar.||
7061|150|P|   High fever, "water pills" (diuretics such as||
7061|151|P|hydrochlorothiazide), too much sweating, diarrhea, or vomiting||
7061|152|P|may cause dehydration and increase your risk of lactic acidosis.||
7061|153|P|Stop taking this medication and tell your doctor right away if||
7061|154|P|you have prolonged diarrhea or vomiting. Be sure to drink enough||
7061|155|P|fluids to prevent dehydration unless your doctor directs you||
7061|156|P|otherwise.||
7061|157|P|   It may be harder to control your blood sugar when your body is||
7061|158|P|stressed (such as due to fever, infection, injury, or surgery).||
7061|159|P|Consult your doctor because increased stress may require a change||
7061|160|P|in your treatment plan, medications, or blood sugar testing.||
7061|161|P|   Older adults may be at greater risk for side effects such as||
7061|162|P|low blood sugar or lactic acidosis.||
7061|163|P|   During pregnancy, this medication should be used only when||
7061|164|P|clearly needed. Discuss the risks and benefits with your doctor.||
7061|165|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
7061|166|P|your doctor for managing your blood sugar while pregnant. Your||
7061|167|P|doctor may change your diabetes treatment during your pregnancy||
7061|168|P|(such as diet and medications including insulin).||
7061|169|P|   Metformin can cause changes in the menstrual cycle (promote||
7061|170|P|ovulation) and increase the risk of becoming pregnant. Consult||
7061|171|P|your doctor or pharmacist about the use of reliable birth control||
7061|172|P|while using this medication.||
7061|173|P|   Metformin passes into breast milk in small amounts. Consult||
7061|174|P|your doctor before breastfeeding.||
7061|175|B|||
7061|176|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7061|177|I|medications work or increase your risk for serious side effects.||
7061|178|I|This document does not contain all possible drug interactions.||
7061|179|I|Keep a list of all the products you use (including||
7061|180|I|prescription/nonprescription drugs and herbal products) and share||
7061|181|I|it with your doctor and pharmacist. Do not start, stop, or change||
7061|182|I|the dosage of any medicines without your doctor's approval.||
7061|183|I|   Beta-blocker medications (such as metoprolol, propranolol,||
7061|184|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
7061|185|I|heartbeat you would usually feel when your blood sugar falls too||
7061|186|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
7061|187|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
7061|188|I|   Many drugs can affect your blood sugar, making it harder to||
7061|189|I|control. Before you start, stop, or change any medication, talk||
7061|190|I|with your doctor or pharmacist about how the medication may||
7061|191|I|affect your blood sugar. Check your blood sugar regularly as||
7061|192|I|directed and share the results with your doctor. Tell your doctor||
7061|193|I|right away if you have symptoms of high or low blood sugar. (See||
7061|194|I|also Side Effects section.) Your doctor may need to adjust your||
7061|195|I|diabetes medication, exercise program, or diet.||
7061|196|B|||
7061|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7061|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7061|199|O|poison control center right away. US residents can call||
7061|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7061|201|O|Overdose can cause lactic acidosis. Symptoms of overdose may||
7061|202|O|include: severe drowsiness, severe nausea/vomiting/diarrhea,||
7061|203|O|rapid breathing, slow/irregular heartbeat.||
7061|204|B|||
7061|205|N|NOTES:  Do not share this medication with others.||
7061|206|N|   Attend a diabetes education program to learn more about how to||
7061|207|N|manage your diabetes with medications, diet, exercise, and||
7061|208|N|regular medical exams.||
7061|209|N|   Learn the symptoms of high and low blood sugar and how to||
7061|210|N|treat low blood sugar. Check your blood sugar regularly as||
7061|211|N|directed and share the results with your doctor.||
7061|212|N|   Lab and/or medical tests (such as kidney function, liver||
7061|213|N|function, blood sugar, hemoglobin A1c, complete blood counts)||
7061|214|N|should be done before you start taking this medication and while||
7061|215|N|you are taking it. Keep all medical and lab appointments. Consult||
7061|216|N|your doctor for more details.||
7061|217|B|||
7061|218|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
7061|219|D|with food. If it is near the time of the next dose, skip the||
7061|220|D|missed dose. Take your next dose at the regular time. Do not||
7061|221|D|double the dose to catch up.||
7061|222|B|||
7061|223|R|STORAGE:  Store at room temperature away from light and moisture.||
7061|224|R|Do not store in the bathroom. Keep all medications away from||
7061|225|R|children and pets.||
7061|226|R|   Do not flush medications down the toilet or pour them into a||
7061|227|R|drain unless instructed to do so. Properly discard this product||
7061|228|R|when it is expired or no longer needed. Consult your pharmacist||
7061|229|R|or local waste disposal company.||
7061|230|B|||
7061|231|M|MEDICAL ALERT:  Your condition can cause complications in a||
7061|232|M|medical emergency. For information about enrolling in MedicAlert,||
7061|233|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7061|234|B|||
7061|235|A|Information last revised November 2025.||
7061|236|A|Copyright(c) 2025 First Databank, Inc.||
7061|237|B|||
7063|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7063|002|Z|does NOT have all possible information about this product. This||
7063|003|Z|information does not assure that this product is safe, effective,||
7063|004|Z|or appropriate for you. This information is not individual||
7063|005|Z|medical advice and does not substitute for the advice of your||
7063|006|Z|health care professional. Always ask your health care||
7063|007|Z|professional for complete information about this product and your||
7063|008|Z|specific health needs.||
7063|009|B|||
7063|010|T|PERMETHRIN CREAM RINSE - TOPICAL||
7063|011|F|(purr-METH-rin)||
7063|012|B|||
7063|013|C|COMMON BRAND NAME(S): NIX||
7063|014|B|||
7063|015|U|USES:  This medication is used to treat head lice, tiny insects||
7063|016|U|that infest and irritate your scalp. It belongs to a class of||
7063|017|U|drugs known as pyrethrins. Permethrin works by paralyzing and||
7063|018|U|killing lice and their eggs (nits).||
7063|019|B|||
7063|020|H|HOW TO USE:  Apply this medication as soon as possible after it||
7063|021|H|is prescribed. When treating head lice, apply this medication to||
7063|022|H|the hair and scalp only. First wash hair with your regular||
7063|023|H|shampoo, but do not use conditioner. Thoroughly rinse the shampoo||
7063|024|H|out with water, and towel-dry hair. Shake this medication well||
7063|025|H|before using. Cover your eyes with a towel while applying this||
7063|026|H|medication. Completely cover the hair and scalp with the medicine||
7063|027|H|(especially behind the ears and on the hairline at the neck).||
7063|028|H|Avoid getting permethrin in your nose, ears, mouth, vagina, or||
7063|029|H|eyes. If the medicine gets in any of these areas, flush with||
7063|030|H|plenty of water. Do not use more medication than prescribed.||
7063|031|H|Leave the medication on your hair for 10 minutes or as directed||
7063|032|H|by your doctor, then rinse with warm water. Towel-dry your hair||
7063|033|H|and comb out any tangles. A single permethrin treatment can help||
7063|034|H|prevent lice from coming back for 14 days. If eyebrows or||
7063|035|H|eyelashes are infested, do not apply this medication to those||
7063|036|H|areas without first consulting your doctor.||
7063|037|H|   Head lice lay small white eggs (nits) at the base of hair||
7063|038|H|close to the scalp, especially on the hairline at the back of the||
7063|039|H|neck and behind the ears. After treatment with this medication,||
7063|040|H|the infected person should be checked by another person for lice||
7063|041|H|and nits using a magnifying glass and bright light. To remove||
7063|042|H|nits, use the special comb provided, and follow the instructions||
7063|043|H|on the package. After combing, re-check the entire head every day||
7063|044|H|for nits you might have missed. Remove any nits by combing, by||
7063|045|H|hand using a disposable glove, or by cutting them out. If live||
7063|046|H|lice are seen 7 days or more after treatment, a second treatment||
7063|047|H|with permethrin or another drug may be needed.||
7063|048|H|   Tell your doctor if your condition lasts or gets worse.||
7063|049|B|||
7063|050|S|SIDE EFFECTS:  Scalp irritation, including itching, swelling, or||
7063|051|S|redness may occur with head lice and temporarily worsen after||
7063|052|S|treatment with permethrin. Mild burning, stinging, tingling, or||
7063|053|S|numbness may also occur. If any of these effects last or get||
7063|054|S|worse, tell your doctor or pharmacist promptly.||
7063|055|S|   Remember that this medication has been prescribed because your||
7063|056|S|doctor has judged that the benefit to you is greater than the||
7063|057|S|risk of side effects. Many people using this medication do not||
7063|058|S|have serious side effects.||
7063|059|S|   A very serious allergic reaction to this drug is rare.||
7063|060|S|However, get medical help right away if you notice any symptoms||
7063|061|S|of a serious allergic reaction, including: rash, itching/swelling||
7063|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7063|063|S|breathing.||
7063|064|S|   This is not a complete list of possible side effects. If you||
7063|065|S|notice other effects not listed above, contact your doctor or||
7063|066|S|pharmacist.||
7063|067|S|   In the US -||
7063|068|S|   Call your doctor for medical advice about side effects. You||
7063|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7063|070|S|www.fda.gov/medwatch.||
7063|071|S|   In Canada - Call your doctor for medical advice about side||
7063|072|S|effects. You may report side effects to Health Canada at||
7063|073|S|1-866-234-2345.||
7063|074|B|||
7063|075|P|PRECAUTIONS:  Before using permethrin, tell your doctor or||
7063|076|P|pharmacist if you are allergic to it; or if you have any other||
7063|077|P|allergies. This product may contain inactive ingredients, which||
7063|078|P|can cause allergic reactions or other problems. Talk to your||
7063|079|P|pharmacist for more details.||
7063|080|P|   Before using this medication, tell your doctor or pharmacist||
7063|081|P|your medical history, especially of: skin infections, asthma.||
7063|082|P|   Constant or forceful scratching of the skin/scalp may lead to||
7063|083|P|a bacterial skin infection. Tell your doctor right away if you||
7063|084|P|develop worsening redness or pus.||
7063|085|P|   Before having surgery, tell your doctor or dentist about all||
7063|086|P|the products you use (including prescription drugs,||
7063|087|P|nonprescription drugs, and herbal products).||
7063|088|P|   Tell your doctor if you are pregnant before using this||
7063|089|P|medication.||
7063|090|P|   It is unknown if this drug passes into breast milk but is||
7063|091|P|unlikely to harm a nursing infant. Consult your doctor before||
7063|092|P|breastfeeding.||
7063|093|B|||
7063|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7063|095|I|medications work or increase your risk for serious side effects.||
7063|096|I|This document does not contain all possible drug interactions.||
7063|097|I|Keep a list of all the products you use (including||
7063|098|I|prescription/nonprescription drugs and herbal products) and share||
7063|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
7063|100|I|the dosage of any medicines without your doctor's approval.||
7063|101|B|||
7063|102|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7063|103|O|has overdosed and has serious symptoms such as passing out or||
7063|104|O|trouble breathing, call 911. Otherwise, call a poison control||
7063|105|O|center right away. US residents can call 1-800-222-1222. Canada||
7063|106|O|residents can call 1-844-764-7669. Symptoms of overdose may||
7063|107|O|include: dizziness, severe headache, severe vomiting, weakness,||
7063|108|O|seizures.||
7063|109|B|||
7063|110|N|NOTES:  Do not share this medication with other person unless||
7063|111|N|directed to do so by your doctor.||
7063|112|N|   One application is usually all that is needed. To avoid giving||
7063|113|N|lice to another person or getting them again, all head wear,||
7063|114|N|scarves, coats, and bed linens should be machine-washed with hot||
7063|115|N|water and dried in a dryer (at high setting) for at least 20||
7063|116|N|minutes, dry cleaned, sealed in a plastic bag for 2 weeks, or||
7063|117|N|sprayed with a disinfectant that kills lice. Brushes or combs||
7063|118|N|should be soaked in hot water (hotter than 130 degrees F/54||
7063|119|N|degrees C) for 10 minutes, soaked in alcohol for 1 hour, or||
7063|120|N|thrown away. Furniture and floors should be thoroughly vacuumed.||
7063|121|N|   People who are in close contact with the infected person, such||
7063|122|N|as members of the same household, should also be checked for lice||
7063|123|N|and nits.||
7063|124|B|||
7063|125|D|MISSED DOSE:  Not applicable.||
7063|126|B|||
7063|127|R|STORAGE:  Store at room temperature. Keep all medications away||
7063|128|R|from children and pets.||
7063|129|R|   Do not flush medications down the toilet or pour them into a||
7063|130|R|drain unless instructed to do so. Properly discard this product||
7063|131|R|when it is expired or no longer needed. Consult your pharmacist||
7063|132|R|or local waste disposal company.||
7063|133|B|||
7063|134|A|Information last revised May 2024.||
7063|135|A|Copyright(c) 2025 First Databank, Inc.||
7063|136|B|||
7069|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7069|002|Z|does NOT have all possible information about this product. This||
7069|003|Z|information does not assure that this product is safe, effective,||
7069|004|Z|or appropriate for you. This information is not individual||
7069|005|Z|medical advice and does not substitute for the advice of your||
7069|006|Z|health care professional. Always ask your health care||
7069|007|Z|professional for complete information about this product and your||
7069|008|Z|specific health needs.||
7069|009|B|||
7069|010|T|GANCICLOVIR - INJECTION||
7069|011|F|(gan-SYE-klo-veer)||
7069|012|B|||
7069|013|C|COMMON BRAND NAME(S): Cytovene||
7069|014|B|||
7069|015|W|WARNING:  Ganciclovir can decrease bone marrow function. This||
7069|016|W|serious, possibly life-threatening side effect may lead to a low||
7069|017|W|number of blood cells such as red cells, white cells, and||
7069|018|W|platelets. This effect can cause anemia, decrease your body's||
7069|019|W|ability to fight an infection, and cause bleeding problems. Your||
7069|020|W|doctor will check the results of your blood tests and adjust your||
7069|021|W|treatment to reduce your risk for these side effects. Get medical||
7069|022|W|help right away if you develop signs of anemia (such as unusual||
7069|023|W|tiredness, fast breathing, pale skin, fast heartbeat), signs of||
7069|024|W|infection (such as sore throat that doesn't go away, fever,||
7069|025|W|chills), and signs of bleeding (such as easy bruising/bleeding,||
7069|026|W|nose bleeds, bleeding gums, bloody/black/tarry stools, vomit that||
7069|027|W|looks like coffee grounds).||
7069|028|W|   Ganciclovir may reduce fertility in men and women. It may also||
7069|029|W|harm an unborn baby. Talk to your doctor for more details.||
7069|030|W|   Ganciclovir has caused tumors in lab animals. Although there||
7069|031|W|is no information in humans, ganciclovir should be considered||
7069|032|W|cancer-causing (carcinogenic). See also How to Use and||
7069|033|W|Precautions sections.||
7069|034|B|||
7069|035|U|USES:  Ganciclovir is an anti-viral drug. It is used to prevent||
7069|036|U|disease caused by a virus called cytomegalovirus (CMV) in people||
7069|037|U|who have received organ or bone marrow transplants. CMV disease||
7069|038|U|can lead to serious infections in the body, including an||
7069|039|U|infection in the eye, called CMV retinitis, that can cause||
7069|040|U|blindness.||
7069|041|U|   Ganciclovir is also used to treat people with weakened immune||
7069|042|U|systems (including people with AIDS) who have CMV retinitis.||
7069|043|U|Ganciclovir works by slowing the growth of the CMV virus. It||
7069|044|U|helps control CMV retinitis and decrease the risk of blindness.||
7069|045|U|It also helps prevent the spread of infection to other areas of||
7069|046|U|the body.||
7069|047|U|   Ganciclovir is not a cure for CMV disease. Some people may||
7069|048|U|have worsening CMV retinitis even with treatment. It is important||
7069|049|U|to have your eyes checked regularly by your doctor.||
7069|050|B|||
7069|051|V|OTHER USES:  This section contains uses of this drug that are not||
7069|052|V|listed in the approved professional labeling for the drug but||
7069|053|V|that may be prescribed by your health care professional. Use this||
7069|054|V|drug for a condition that is listed in this section only if it||
7069|055|V|has been so prescribed by your health care professional.||
7069|056|V|   This drug may also be used to reduce the risk of CMV disease||
7069|057|V|in people receiving cancer chemotherapy treatment.||
7069|058|B|||
7069|059|H|HOW TO USE:  This medication is given by injection into a vein||
7069|060|H|usually over a 1-hour period. Do not give this medication any||
7069|061|H|faster than prescribed because doing so will increase the risk of||
7069|062|H|side effects. Ganciclovir is given as directed by your doctor,||
7069|063|H|usually every 12 hours for the first few weeks, and then once a||
7069|064|H|day either 5 or 7 times a week after that. The dosage and length||
7069|065|H|of treatment is based on your weight, medical condition, and||
7069|066|H|response to treatment.||
7069|067|H|   Drink plenty of fluids while using this medication unless your||
7069|068|H|doctor directs you otherwise.||
7069|069|H|   If you are using this medication at home, learn all||
7069|070|H|preparation and usage instructions from your health care||
7069|071|H|professional. Before using, check this product for particles or||
7069|072|H|discoloration. If either is present, do not use the liquid. Wear||
7069|073|H|gloves when you handle this medication. Avoid direct contact with||
7069|074|H|the liquid. Avoid getting it on your skin or in your mucous||
7069|075|H|membranes, including your mouth, nose, and eyes. If contact||
7069|076|H|should occur, wash the area thoroughly with soap and water. If||
7069|077|H|this medication gets in your eyes, rinse them thoroughly with||
7069|078|H|plain water.||
7069|079|H|   Learn how to store and discard needles and medical supplies||
7069|080|H|safely. Special disposal is required for this medication and all||
7069|081|H|injection supplies used with it. Consult your pharmacist for more||
7069|082|H|information.||
7069|083|H|   This medication works best when the amount of drug in your||
7069|084|H|body is kept at a constant level. Use this drug at evenly spaced||
7069|085|H|intervals. To help you remember, use it at the same time(s) each||
7069|086|H|day.||
7069|087|H|   Keep using this medication exactly as prescribed by your||
7069|088|H|doctor. Do not skip any doses or stop using this medication even||
7069|089|H|for a short time unless directed to do so by your doctor.||
7069|090|H|Skipping or stopping treatment without approval from your doctor||
7069|091|H|may make the infection worse.||
7069|092|H|   Tell your doctor if your condition gets worse (such as||
7069|093|H|worsening vision).||
7069|094|B|||
7069|095|S|SIDE EFFECTS:  See also Warning section.||
7069|096|S|   Diarrhea, upset stomach, dizziness, drowsiness, unsteadiness,||
7069|097|S|shaking (tremors), or pain/redness/irritation at the injection||
7069|098|S|site may occur. If any of these effects last or get worse, tell||
7069|099|S|your doctor or pharmacist promptly.||
7069|100|S|   Remember that this medication has been prescribed because your||
7069|101|S|doctor has judged that the benefit to you is greater than the||
7069|102|S|risk of side effects. Many people using this medication do not||
7069|103|S|have serious side effects.||
7069|104|S|   Tell your doctor right away if you have any serious side||
7069|105|S|effects, including: mental/mood changes (such as confusion,||
7069|106|S|hallucinations), signs of kidney problems (such as change in the||
7069|107|S|amount of urine), seizures.||
7069|108|S|   A very serious allergic reaction to this drug is rare.||
7069|109|S|However, get medical help right away if you notice any symptoms||
7069|110|S|of a serious allergic reaction, including: rash, itching/swelling||
7069|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7069|112|S|breathing.||
7069|113|S|   This is not a complete list of possible side effects. If you||
7069|114|S|notice other effects not listed above, contact your doctor or||
7069|115|S|pharmacist.||
7069|116|S|   In the US -||
7069|117|S|   Call your doctor for medical advice about side effects. You||
7069|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7069|119|S|www.fda.gov/medwatch.||
7069|120|S|   In Canada - Call your doctor for medical advice about side||
7069|121|S|effects. You may report side effects to Health Canada at||
7069|122|S|1-866-234-2345.||
7069|123|B|||
7069|124|P|PRECAUTIONS:  Before using ganciclovir, tell your doctor or||
7069|125|P|pharmacist if you are allergic to it; or to valganciclovir or||
7069|126|P|acyclovir; or if you have any other allergies. This product may||
7069|127|P|contain inactive ingredients, which can cause allergic reactions||
7069|128|P|or other problems. Talk to your pharmacist for more details.||
7069|129|P|   Before using this medication, tell your doctor or pharmacist||
7069|130|P|your medical history, especially of: kidney problems, a low||
7069|131|P|number of blood cells (red or white blood cells, platelets),||
7069|132|P|radiation treatment.||
7069|133|P|   This drug may make you dizzy or drowsy or make it harder for||
7069|134|P|you to think clearly. Alcohol or marijuana (cannabis) can worsen||
7069|135|P|these effects. Do not drive, use machinery, or do anything that||
7069|136|P|needs alertness until you can do it safely. Limit alcoholic||
7069|137|P|beverages. Talk to your doctor if you are using marijuana||
7069|138|P|(cannabis).||
7069|139|P|   Ganciclovir can make you more likely to get infections or may||
7069|140|P|make current infections worse. Stay away from anyone who has an||
7069|141|P|infection that may easily spread (such as chickenpox, COVID-19,||
7069|142|P|measles, flu). Talk to your doctor if you have been exposed to an||
7069|143|P|infection or for more details.||
7069|144|P|   Tell your health care professional that you are using||
7069|145|P|ganciclovir before having any immunizations/vaccinations. Avoid||
7069|146|P|contact with people who have recently received live vaccines||
7069|147|P|(such as flu vaccine inhaled through the nose).||
7069|148|P|   To lower the chance of getting cut, bruised, or injured, use||
7069|149|P|caution with sharp objects like razors and nail cutters, and||
7069|150|P|avoid activities such as contact sports.||
7069|151|P|   Before having surgery, tell your doctor or dentist about all||
7069|152|P|the products you use (including prescription drugs,||
7069|153|P|nonprescription drugs, and herbal products).||
7069|154|P|   Older adults may be at greater risk for kidney problems while||
7069|155|P|using this drug.||
7069|156|P|   Women who are pregnant or who may become pregnant should not||
7069|157|P|handle this medication.||
7069|158|P|   During pregnancy, this medication should be used only when||
7069|159|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
7069|160|P|benefits with your doctor. Women of childbearing age should have||
7069|161|P|a pregnancy test before starting this medication. To prevent||
7069|162|P|pregnancy, men with female partners should always use effective||
7069|163|P|barrier protection (such as latex or polyurethane condoms) during||
7069|164|P|all sexual activity during treatment and for at least 90 days||
7069|165|P|after stopping the medication. Women of childbearing age who are||
7069|166|P|using ganciclovir should use reliable forms of birth control||
7069|167|P|(such as birth control pills and condoms) during treatment and||
7069|168|P|for at least 30 days after stopping the medication. Consult your||
7069|169|P|doctor for more details.||
7069|170|P|   It is unknown if this medication passes into breast milk.||
7069|171|P|Because of the possible risk to the infant, breastfeeding is not||
7069|172|P|recommended while using this medication. Consult your doctor||
7069|173|P|before breastfeeding.||
7069|174|B|||
7069|175|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7069|176|I|medications work or increase your risk for serious side effects.||
7069|177|I|This document does not contain all possible drug interactions.||
7069|178|I|Keep a list of all the products you use (including||
7069|179|I|prescription/nonprescription drugs and herbal products) and share||
7069|180|I|it with your doctor and pharmacist. Do not start, stop, or change||
7069|181|I|the dosage of any medicines without your doctor's approval.||
7069|182|I|   Some products that may interact with this drug include:||
7069|183|I|imipenem/cilastatin, maribavir.||
7069|184|I|   You may be taking other drugs that decrease bone marrow||
7069|185|I|function and lower your number of blood cells (such as cancer||
7069|186|I|chemotherapy, trimethoprim/sulfamethoxazole, zidovudine) or other||
7069|187|I|drugs that may cause kidney problems (such as cyclosporine). Your||
7069|188|I|doctor or pharmacist will monitor you closely and adjust your||
7069|189|I|medications to decrease your risk of serious side effects.||
7069|190|I|   Ganciclovir is very similar to valganciclovir. Do not use||
7069|191|I|medications containing valganciclovir while using ganciclovir.||
7069|192|B|||
7069|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7069|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7069|195|O|poison control center right away. US residents can call||
7069|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7069|197|B|||
7069|198|N|NOTES:  Do not share this medication with others.||
7069|199|N|   Lab and/or medical tests (such as complete blood count, kidney||
7069|200|N|function, eye exams) should be done while you are using this||
7069|201|N|medication. Keep all medical and lab appointments. Consult your||
7069|202|N|doctor for more details.||
7069|203|B|||
7069|204|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7069|205|D|If it is near the time of the next dose, skip the missed dose.||
7069|206|D|Use your next dose at the regular time. Do not double the dose to||
7069|207|D|catch up.||
7069|208|B|||
7069|209|R|STORAGE:  Consult the product instructions and your pharmacist||
7069|210|R|for storage details. Keep all medications away from children and||
7069|211|R|pets.||
7069|212|R|   Do not flush medications down the toilet or pour them into a||
7069|213|R|drain unless instructed to do so. Properly discard this product||
7069|214|R|when it is expired or no longer needed. Consult your pharmacist||
7069|215|R|or local waste disposal company.||
7069|216|B|||
7069|217|A|Information last revised May 2025.||
7069|218|A|Copyright(c) 2025 First Databank, Inc.||
7069|219|B|||
7070|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7070|002|Z|does NOT have all possible information about this product. This||
7070|003|Z|information does not assure that this product is safe, effective,||
7070|004|Z|or appropriate for you. This information is not individual||
7070|005|Z|medical advice and does not substitute for the advice of your||
7070|006|Z|health care professional. Always ask your health care||
7070|007|Z|professional for complete information about this product and your||
7070|008|Z|specific health needs.||
7070|009|B|||
7070|010|T|AMIODARONE - ORAL||
7070|011|F|(A-mee-OH-da-rone)||
7070|012|B|||
7070|013|C|COMMON BRAND NAME(S): Cordarone, Pacerone||
7070|014|B|||
7070|015|W|WARNING:  Though this medication often gives great benefits to||
7070|016|W|people with irregular heartbeat, it may rarely worsen an||
7070|017|W|irregular heartbeat or cause serious (sometimes fatal) side||
7070|018|W|effects. When starting treatment with this drug, your doctor may||
7070|019|W|have you stay in the hospital for proper monitoring.||
7070|020|W|   Amiodarone may take 2 weeks or longer to have an effect in||
7070|021|W|your body. Also, this drug stays in your body for weeks to||
7070|022|W|months, even after you are no longer taking it. Serious side||
7070|023|W|effects may occur weeks to months after taking amiodarone.||
7070|024|W|Serious side effects may include lung or liver problems. Tell||
7070|025|W|your doctor right away if you notice any symptoms of lung or||
7070|026|W|liver problems such as nausea/vomiting that doesn't stop, cough,||
7070|027|W|shortness of breath, chest pain, coughing up blood, dark urine,||
7070|028|W|severe stomach/abdominal pain, or yellowing eyes/skin.||
7070|029|B|||
7070|030|U|USES:  This medication is used to treat certain types of serious||
7070|031|U|(possibly fatal) irregular heartbeat (such as recurrent||
7070|032|U|ventricular fibrillation/tachycardia). It is used to restore||
7070|033|U|normal heart rhythm and maintain a regular, steady heartbeat.||
7070|034|U|Amiodarone is known as an anti-arrhythmic drug. It works by||
7070|035|U|blocking certain electrical signals in the heart that can cause||
7070|036|U|an irregular heartbeat.||
7070|037|B|||
7070|038|H|HOW TO USE:  Read the Medication Guide provided by your||
7070|039|H|pharmacist before you start using amiodarone and each time you||
7070|040|H|get a refill. If you have any questions, consult your doctor or||
7070|041|H|pharmacist.||
7070|042|H|   Take this medication by mouth as directed by your doctor,||
7070|043|H|usually once or twice daily. You may take this medication with or||
7070|044|H|without food, but it is important to choose one way and take this||
7070|045|H|medication the same way with every dose.||
7070|046|H|   Avoid eating grapefruit or drinking grapefruit juice while||
7070|047|H|using this medication unless your doctor or pharmacist says you||
7070|048|H|may do so safely. Grapefruit can increase the chance of side||
7070|049|H|effects with this medicine. Ask your doctor or pharmacist for||
7070|050|H|more details.||
7070|051|H|   The dosage is based on your medical condition and response to||
7070|052|H|treatment. Your doctor may direct you to start this medication at||
7070|053|H|a higher dose and gradually decrease your dose. Follow your||
7070|054|H|doctor's instructions carefully. Do not stop taking this||
7070|055|H|medication or change the dose without first consulting your||
7070|056|H|doctor.||
7070|057|H|   Tell your doctor if your condition does not get better or if||
7070|058|H|it gets worse.||
7070|059|B|||
7070|060|S|SIDE EFFECTS:  See also Warning section.||
7070|061|S|   Nausea, vomiting, constipation, loss of appetite, shaking, or||
7070|062|S|tiredness may occur. If any of these effects last or get worse,||
7070|063|S|tell your doctor promptly.||
7070|064|S|   Remember that this medication has been prescribed because your||
7070|065|S|doctor has judged that the benefit to you is greater than the||
7070|066|S|risk of side effects. Many people using this medication do not||
7070|067|S|have serious side effects.||
7070|068|S|   Tell your doctor right away if you have any serious side||
7070|069|S|effects, including: easy bruising/bleeding, loss of coordination,||
7070|070|S|tingling/numbness of the hands or feet, uncontrolled movements,||
7070|071|S|new or worsening symptoms of heart failure (such as shortness of||
7070|072|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
7070|073|S|weight gain).||
7070|074|S|   Get medical help right away if you have any very serious side||
7070|075|S|effects, including: faster/slower/more irregular heartbeat,||
7070|076|S|severe dizziness, fainting.||
7070|077|S|   Amiodarone may rarely cause thyroid problems. Either low||
7070|078|S|thyroid function or overactive thyroid function may occur. Tell||
7070|079|S|your doctor right away if you develop any symptoms of low or||
7070|080|S|overactive thyroid, including cold or heat intolerance,||
7070|081|S|unexplained weight loss/gain, thinning hair, unusual sweating,||
7070|082|S|nervousness, irritability, restlessness, or lump/growth in the||
7070|083|S|front of the neck (goiter).||
7070|084|S|   This drug may cause your skin to be more sensitive to the sun.||
7070|085|S|With long-term treatment, you may rarely develop blue-gray color||
7070|086|S|of the skin. This effect is not harmful and color may return to||
7070|087|S|normal after the drug is stopped. To help prevent skin effects,||
7070|088|S|limit your time in the sun. Avoid tanning booths and sunlamps.||
7070|089|S|Use sunscreen and wear protective clothing when outdoors. Tell||
7070|090|S|your doctor right away if you get sunburned or have skin||
7070|091|S|blisters/redness.||
7070|092|S|   This drug may rarely cause vision changes. Very rarely, cases||
7070|093|S|of permanent blindness have been reported. Tell your doctor right||
7070|094|S|away if you develop any vision changes (such as seeing halos or||
7070|095|S|blurred vision).||
7070|096|S|   A very serious allergic reaction to this drug is rare.||
7070|097|S|However, get medical help right away if you notice any symptoms||
7070|098|S|of a serious allergic reaction, including: rash, itching/swelling||
7070|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7070|100|S|breathing.||
7070|101|S|   This is not a complete list of possible side effects. If you||
7070|102|S|notice other effects not listed above, contact your doctor or||
7070|103|S|pharmacist.||
7070|104|S|   In the US -||
7070|105|S|   Call your doctor for medical advice about side effects. You||
7070|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7070|107|S|www.fda.gov/medwatch.||
7070|108|S|   In Canada - Call your doctor for medical advice about side||
7070|109|S|effects. You may report side effects to Health Canada at||
7070|110|S|1-866-234-2345.||
7070|111|B|||
7070|112|P|PRECAUTIONS:  See also Side Effects section.||
7070|113|P|   Before taking amiodarone, tell your doctor or pharmacist if||
7070|114|P|you are allergic to it; or to iodine; or if you have any other||
7070|115|P|allergies. This product may contain inactive ingredients, which||
7070|116|P|can cause allergic reactions or other problems. Talk to your||
7070|117|P|pharmacist for more details.||
7070|118|P|   Before using this medication, tell your doctor or pharmacist||
7070|119|P|your medical history, especially of: liver disease, lung disease,||
7070|120|P|thyroid problems.||
7070|121|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7070|122|P|can make you more dizzy. Do not drive, use machinery, or do||
7070|123|P|anything that needs alertness until you can do it safely. Limit||
7070|124|P|alcoholic beverages. Talk to your doctor if you are using||
7070|125|P|marijuana (cannabis).||
7070|126|P|   Before having surgery, tell your doctors or dentist about all||
7070|127|P|the products you use (including prescription drugs,||
7070|128|P|nonprescription drugs, and herbal products).||
7070|129|P|   Amiodarone may cause a condition that affects the heart rhythm||
7070|130|P|(QT prolongation). QT prolongation can rarely cause serious||
7070|131|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
7070|132|P|as severe dizziness, fainting) that need medical attention right||
7070|133|P|away.||
7070|134|P|   The risk of QT prolongation may be increased if you have||
7070|135|P|certain medical conditions or are taking other drugs that may||
7070|136|P|cause QT prolongation. Before using amiodarone, tell your doctor||
7070|137|P|or pharmacist of all the drugs you take and if you have any of||
7070|138|P|the following conditions: certain heart problems (heart failure,||
7070|139|P|slow heartbeat, QT prolongation in the EKG), family history of||
7070|140|P|certain heart problems (QT prolongation in the EKG, sudden||
7070|141|P|cardiac death).||
7070|142|P|   Low levels of potassium or magnesium in the blood may also||
7070|143|P|increase your risk of QT prolongation. This risk may increase if||
7070|144|P|you use certain drugs (such as diuretics/"water pills") or if you||
7070|145|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7070|146|P|Talk to your doctor about using amiodarone safely.||
7070|147|P|   Older adults may be more sensitive to the side effects of this||
7070|148|P|drug, especially QT prolongation (see above), thyroid problems||
7070|149|P|(see Side Effects section), lung problems (see Warning section).||
7070|150|P|   Tell your doctor if you are pregnant or plan to become||
7070|151|P|pregnant. You should not become pregnant while using amiodarone.||
7070|152|P|Amiodarone may harm an unborn baby. If you become pregnant, talk||
7070|153|P|to your doctor right away about the risks and benefits of this||
7070|154|P|medication.||
7070|155|P|   Amiodarone passes into breast milk and may have undesirable||
7070|156|P|effects on a nursing infant. Breastfeeding is not recommended||
7070|157|P|while using this medication. Consult your doctor before||
7070|158|P|breastfeeding.||
7070|159|B|||
7070|160|I|DRUG INTERACTIONS:  See also How to Use section.||
7070|161|I|   Drug interactions may change how your medications work or||
7070|162|I|increase your risk for serious side effects. This document does||
7070|163|I|not contain all possible drug interactions. Keep a list of all||
7070|164|I|the products you use (including prescription/nonprescription||
7070|165|I|drugs and herbal products) and share it with your doctor and||
7070|166|I|pharmacist. Do not start, stop, or change the dosage of any||
7070|167|I|medicines without your doctor's approval.||
7070|168|I|   Some products that may interact with this drug include:||
7070|169|I|fingolimod, certain drugs to treat hepatitis C||
7070|170|I|(ledipasvir/sofosbuvir, sofosbuvir).||
7070|171|I|   Many drugs besides amiodarone may affect the heart rhythm (QT||
7070|172|I|prolongation), including dofetilide, levoketoconazole, pimozide,||
7070|173|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
7070|174|I|clarithromycin, erythromycin), quinolone antibiotics (such as||
7070|175|I|levofloxacin), among others.||
7070|176|I|   Other medications can affect the removal of amiodarone from||
7070|177|I|your body, which may affect how amiodarone works. Examples||
7070|178|I|include azole antifungals (such as itraconazole), cimetidine,||
7070|179|I|cobicistat, protease inhibitors (such as fosamprenavir),||
7070|180|I|rifamycins (such as rifampin), St. John's wort, among others.||
7070|181|I|   Amiodarone can slow down the removal of other medications from||
7070|182|I|your body, which may affect how they work. Examples of affected||
7070|183|I|drugs include clopidogrel, deuruxolitinib, macitentan, phenytoin,||
7070|184|I|certain "statin" drugs (atorvastatin, lovastatin), trazodone,||
7070|185|I|warfarin, among others.||
7070|186|B|||
7070|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7070|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7070|189|O|poison control center right away. US residents can call||
7070|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7070|191|O|Symptoms of overdose may include: weakness, severe dizziness,||
7070|192|O|very slow heartbeat, fainting.||
7070|193|B|||
7070|194|N|NOTES:  Do not share this medication with others.||
7070|195|N|   Lab and/or medical tests (such as EKG, chest X-rays,||
7070|196|N|lung/liver/thyroid function, eye exams) should be done while you||
7070|197|N|are taking this medication. Keep all medical and lab||
7070|198|N|appointments. Consult your doctor for more details.||
7070|199|B|||
7070|200|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7070|201|D|remember. If it is near the time of the next dose, skip the||
7070|202|D|missed dose. Take your next dose at the regular time. Do not||
7070|203|D|double the dose to catch up.||
7070|204|B|||
7070|205|R|STORAGE:  Store at room temperature away from light and moisture.||
7070|206|R|Do not store in the bathroom. Keep all medications away from||
7070|207|R|children and pets.||
7070|208|R|   Do not flush medications down the toilet or pour them into a||
7070|209|R|drain unless instructed to do so. Properly discard this product||
7070|210|R|when it is expired or no longer needed. Consult your pharmacist||
7070|211|R|or local waste disposal company.||
7070|212|B|||
7070|213|M|MEDICAL ALERT:  Your condition can cause complications in a||
7070|214|M|medical emergency. For information about enrolling in MedicAlert,||
7070|215|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7070|216|B|||
7070|217|A|Information last revised June 2025.||
7070|218|A|Copyright(c) 2025 First Databank, Inc.||
7070|219|B|||
7073|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7073|002|Z|does NOT have all possible information about this product. This||
7073|003|Z|information does not assure that this product is safe, effective,||
7073|004|Z|or appropriate for you. This information is not individual||
7073|005|Z|medical advice and does not substitute for the advice of your||
7073|006|Z|health care professional. Always ask your health care||
7073|007|Z|professional for complete information about this product and your||
7073|008|Z|specific health needs.||
7073|009|B|||
7073|010|T|DOXYCYCLINE - ORAL||
7073|011|F|(dox-ee-SYE-kleen)||
7073|012|B|||
7073|013|C|COMMON BRAND NAME(S): Acticlate, Monodox, Vibra-Tabs, Vibramycin||
7073|014|B|||
7073|015|U|USES:  This medication is used to treat a wide variety of||
7073|016|U|bacterial infections, including those that cause acne. This||
7073|017|U|medication is also used to prevent malaria. This medication is||
7073|018|U|known as a tetracycline antibiotic. It works by stopping the||
7073|019|U|growth of bacteria.||
7073|020|U|   This antibiotic treats only bacterial infections. It will not||
7073|021|U|work for viral infections (such as common cold, flu). Using any||
7073|022|U|antibiotic when it is not needed can cause it to not work for||
7073|023|U|future infections.||
7073|024|B|||
7073|025|V|OTHER USES:  This section contains uses of this drug that are not||
7073|026|V|listed in the approved professional labeling for the drug but||
7073|027|V|that may be prescribed by your health care professional. Use this||
7073|028|V|drug for a condition that is listed in this section only if it||
7073|029|V|has been so prescribed by your health care professional.||
7073|030|V|   This drug may also be used for a certain skin condition||
7073|031|V|(rosacea).||
7073|032|B|||
7073|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7073|034|H|from your pharmacist before you start taking doxycycline and each||
7073|035|H|time you get a refill. If you have any questions, ask your doctor||
7073|036|H|or pharmacist.||
7073|037|H|   Take this medication by mouth as directed by your doctor,||
7073|038|H|usually 1 or 2 times daily. Take this medication with a full||
7073|039|H|glass of water (8 ounces/240 milliliters) unless directed||
7073|040|H|otherwise. Do not lie down for at least 10 minutes after taking||
7073|041|H|this medication. Your doctor may direct you to take this||
7073|042|H|medication with or right after food or milk to reduce stomach||
7073|043|H|upset. Follow your doctor's directions on how to take this||
7073|044|H|medication.||
7073|045|H|   Take this medication 2 to 3 hours before or after taking any||
7073|046|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
7073|047|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
7073|048|H|sucralfate, and vitamins/minerals. These products bind with||
7073|049|H|doxycycline, preventing your body from fully absorbing the drug.||
7073|050|H|   When using to prevent malaria, take this medication as||
7073|051|H|directed by your doctor, usually once daily, starting 1 to 2 days||
7073|052|H|before travel. Continue to take this medication daily while in||
7073|053|H|the malarious area. Upon returning home, you should keep taking||
7073|054|H|this medication for 4 more weeks. If you are unable to finish||
7073|055|H|this course of doxycycline, contact your doctor.||
7073|056|H|   If you are using the liquid form of this medication, shake the||
7073|057|H|bottle well before each dose. Carefully measure the dose using a||
7073|058|H|special measuring device/spoon. Do not use a household spoon||
7073|059|H|because you may not get the correct dose.||
7073|060|H|   The dosage is based on your medical condition and response to||
7073|061|H|treatment. Children's dosage may also be based on weight.||
7073|062|H|   For the best effect, take this antibiotic at evenly spaced||
7073|063|H|times. To help you remember, take this medication at the same||
7073|064|H|time(s) every day.||
7073|065|H|   Continue to take this medication until the full prescribed||
7073|066|H|amount is finished, even if symptoms disappear after a few days.||
7073|067|H|Stopping the medication too early may result in a return of the||
7073|068|H|infection.||
7073|069|H|   Tell your doctor if your condition lasts or gets worse.||
7073|070|B|||
7073|071|S|SIDE EFFECTS:  Stomach upset, diarrhea, nausea, or vomiting may||
7073|072|S|occur. If any of these effects last or get worse, tell your||
7073|073|S|doctor or pharmacist promptly.||
7073|074|S|   Remember that this medication has been prescribed because your||
7073|075|S|doctor has judged that the benefit to you is greater than the||
7073|076|S|risk of side effects. Many people using this medication do not||
7073|077|S|have serious side effects.||
7073|078|S|   Tell your doctor right away if you have any serious side||
7073|079|S|effects, including: painful/difficult swallowing, signs of kidney||
7073|080|S|problems (such as change in the amount of urine).||
7073|081|S|   Tetracycline drugs such as doxycycline may rarely cause||
7073|082|S|increased pressure around the brain (intracranial||
7073|083|S|hypertension-IH). The risk of this side effect is greater for||
7073|084|S|women of childbearing age who are overweight or who have had IH||
7073|085|S|in the past. If IH develops, it usually goes away after||
7073|086|S|doxycycline is stopped; however, there is a chance of permanent||
7073|087|S|vision loss or blindness. Get medical help right away if you||
7073|088|S|have: headache that is severe or doesn't go away, nausea/vomiting||
7073|089|S|that doesn't stop, vision changes (such as blurred/double vision,||
7073|090|S|decreased vision, sudden blindness).||
7073|091|S|   This medication may rarely cause a severe intestinal condition||
7073|092|S|due to a bacteria called C. difficile. This condition may occur||
7073|093|S|during treatment or weeks to months after treatment has stopped.||
7073|094|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7073|095|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7073|096|S|stool.||
7073|097|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7073|098|S|products because they may make symptoms worse.||
7073|099|S|   Use of this medication for prolonged or repeated periods may||
7073|100|S|result in oral thrush or a new vaginal yeast infection. Contact||
7073|101|S|your doctor if you notice white patches in your mouth, a change||
7073|102|S|in vaginal discharge, or other new symptoms.||
7073|103|S|   A very serious allergic reaction to this drug is rare.||
7073|104|S|However, get medical help right away if you notice any symptoms||
7073|105|S|of a serious allergic reaction, including: fever that doesn't go||
7073|106|S|away, new or worsening lymph node swelling, rash,||
7073|107|S|itching/swelling (especially of the face/tongue/throat), severe||
7073|108|S|dizziness, trouble breathing.||
7073|109|S|   This is not a complete list of possible side effects. If you||
7073|110|S|notice other effects not listed above, contact your doctor or||
7073|111|S|pharmacist.||
7073|112|S|   In the US -||
7073|113|S|   Call your doctor for medical advice about side effects. You||
7073|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7073|115|S|www.fda.gov/medwatch.||
7073|116|S|   In Canada - Call your doctor for medical advice about side||
7073|117|S|effects. You may report side effects to Health Canada at||
7073|118|S|1-866-234-2345.||
7073|119|B|||
7073|120|P|PRECAUTIONS:  See also Side Effects section.||
7073|121|P|   Before taking doxycycline, tell your doctor or pharmacist if||
7073|122|P|you are allergic to it; or to other tetracyclines (such as||
7073|123|P|minocycline); or if you have any other allergies. This product||
7073|124|P|may contain inactive ingredients (such as sulfites, soy found in||
7073|125|P|some brands), which can cause allergic reactions or other||
7073|126|P|problems. Talk to your pharmacist for more details.||
7073|127|P|   Before using this medication, tell your doctor or pharmacist||
7073|128|P|your medical history, especially of: trouble swallowing,||
7073|129|P|esophagus problems (such as hiatal hernia or reflux/heartburn).||
7073|130|P|   Doxycycline may cause live bacterial vaccines (such as typhoid||
7073|131|P|vaccine) to not work well. Tell your health care professional||
7073|132|P|that you are using doxycycline before having any||
7073|133|P|immunizations/vaccinations.||
7073|134|P|   Before having surgery, tell your doctor or dentist about all||
7073|135|P|the products you use (including prescription drugs,||
7073|136|P|nonprescription drugs, and herbal products).||
7073|137|P|   This medication may make you more sensitive to the sun. Limit||
7073|138|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
7073|139|P|sunscreen and wear protective clothing when outdoors. Tell your||
7073|140|P|doctor right away if you get sunburned or have skin||
7073|141|P|blisters/redness.||
7073|142|P|   Children younger than 8 years may be more sensitive to the||
7073|143|P|side effects of doxycycline, especially tooth discoloration.||
7073|144|P|Tooth discoloration has also occurred in older children and young||
7073|145|P|adults. Discuss the risks and benefits of this medication with||
7073|146|P|the doctor.||
7073|147|P|   Tell your doctor if you are pregnant or plan to become||
7073|148|P|pregnant. You should not become pregnant while using doxycycline.||
7073|149|P|Doxycycline may harm an unborn baby. If you become pregnant, talk||
7073|150|P|to your doctor right away about the risks and benefits of this||
7073|151|P|medication.||
7073|152|P|   This medication passes into breast milk. Consult your doctor||
7073|153|P|before breastfeeding.||
7073|154|B|||
7073|155|I|DRUG INTERACTIONS:  See also How to Use section.||
7073|156|I|   Drug interactions may change how your medications work or||
7073|157|I|increase your risk for serious side effects. This document does||
7073|158|I|not contain all possible drug interactions. Keep a list of all||
7073|159|I|the products you use (including prescription/nonprescription||
7073|160|I|drugs and herbal products) and share it with your doctor and||
7073|161|I|pharmacist. Do not start, stop, or change the dosage of any||
7073|162|I|medicines without your doctor's approval.||
7073|163|I|   Some products that may interact with this drug include:||
7073|164|I|retinoid medications taken by mouth (such as acitretin,||
7073|165|I|isotretinoin), strontium.||
7073|166|I|   This medication may interfere with certain lab tests (such as||
7073|167|I|urine catecholamine levels), possibly causing false test results.||
7073|168|I|Make sure lab personnel and all your doctors know you use this||
7073|169|I|drug.||
7073|170|B|||
7073|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7073|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7073|173|O|poison control center right away. US residents can call||
7073|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7073|175|B|||
7073|176|N|NOTES:  Do not share this medication with others.||
7073|177|N|   If this medication is being used to prevent malaria, it is||
7073|178|N|important to understand that it is still possible to get the||
7073|179|N|disease even if you have used this medication. Avoid being bitten||
7073|180|N|by mosquitoes when trying to prevent malaria. Avoid contact with||
7073|181|N|mosquitoes, especially from dusk to dawn, by staying in||
7073|182|N|well-screened areas, wearing protective clothing, and using||
7073|183|N|insect repellent and bed nets.||
7073|184|N|   This medication has been prescribed for your current condition||
7073|185|N|only. Do not use it later for another infection unless your||
7073|186|N|doctor tells you to.||
7073|187|N|   Lab and/or medical tests (such as complete blood count,||
7073|188|N|liver/kidney function) may be done while you are taking this||
7073|189|N|medication. Keep all medical and lab appointments. Consult your||
7073|190|N|doctor for more details.||
7073|191|B|||
7073|192|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7073|193|D|remember. If it is near the time of the next dose, skip the||
7073|194|D|missed dose. Take your next dose at the regular time. Do not||
7073|195|D|double the dose to catch up.||
7073|196|B|||
7073|197|R|STORAGE:  Store at room temperature away from light and moisture.||
7073|198|R|Different brands of this medication have different storage needs.||
7073|199|R|Check the product package for instructions on how to store your||
7073|200|R|brand, or ask your pharmacist. Do not store in the bathroom. Keep||
7073|201|R|all medications away from children and pets.||
7073|202|R|   Do not flush medications down the toilet or pour them into a||
7073|203|R|drain unless instructed to do so. Properly discard this product||
7073|204|R|when it is expired or no longer needed. Taking outdated||
7073|205|R|tetracycline-related drugs can result in serious illness. Consult||
7073|206|R|your pharmacist or local waste disposal company.||
7073|207|B|||
7073|208|A|Information last revised September 2025.||
7073|209|A|Copyright(c) 2025 First Databank, Inc.||
7073|210|B|||
7074|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7074|002|Z|does NOT have all possible information about this product. This||
7074|003|Z|information does not assure that this product is safe, effective,||
7074|004|Z|or appropriate for you. This information is not individual||
7074|005|Z|medical advice and does not substitute for the advice of your||
7074|006|Z|health care professional. Always ask your health care||
7074|007|Z|professional for complete information about this product and your||
7074|008|Z|specific health needs.||
7074|009|B|||
7074|010|T|LEVOTHYROXINE - ORAL||
7074|011|F|(lee-voe-thye-ROX-een)||
7074|012|B|||
7074|013|C|COMMON BRAND NAME(S): Levothroid, Levoxyl, Synthroid, Unithroid||
7074|014|B|||
7074|015|W|WARNING:  This medication should not be used for weight loss.||
7074|016|W|Normal doses of this medication will not work for weight loss,||
7074|017|W|and large doses of this medication may cause serious, possibly||
7074|018|W|fatal side effects, especially when taken with diet pills.||
7074|019|B|||
7074|020|U|USES:  Levothyroxine is used to treat an underactive thyroid||
7074|021|U|(hypothyroidism). It replaces or provides more thyroid hormone,||
7074|022|U|which is normally produced by the thyroid gland. Low thyroid||
7074|023|U|hormone levels can occur naturally or when the thyroid gland is||
7074|024|U|injured by radiation/medications or removed by surgery. Having||
7074|025|U|enough thyroid hormone is important for maintaining normal mental||
7074|026|U|and physical activity. In children, having enough thyroid hormone||
7074|027|U|is important for normal mental and physical development.||
7074|028|U|   This medication is also used to treat other types of thyroid||
7074|029|U|disorders (such as thyroid cancer).||
7074|030|U|   This medication should not be used to treat infertility unless||
7074|031|U|it is caused by low thyroid hormone levels.||
7074|032|B|||
7074|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7074|034|H|from your pharmacist before you start taking levothyroxine and||
7074|035|H|each time you get a refill. If you have any questions, ask your||
7074|036|H|doctor or pharmacist.||
7074|037|H|   Take this medication by mouth as directed by your doctor,||
7074|038|H|usually once daily on an empty stomach, 30 minutes to 1 hour||
7074|039|H|before breakfast. Take this medication with a full glass of water||
7074|040|H|unless your doctor directs you otherwise.||
7074|041|H|   If you are taking the capsule form of this medication, swallow||
7074|042|H|it whole. Do not split, crush, or chew. People who cannot swallow||
7074|043|H|the capsule whole (such as infants or small children) should use||
7074|044|H|the tablet form of the medication.||
7074|045|H|   For infants or children who cannot swallow whole tablets,||
7074|046|H|crush the tablet and mix in 1 to 2 teaspoons (5 to 10||
7074|047|H|milliliters) of water, and give using a spoon or dropper right||
7074|048|H|away. Do not prepare a supply in advance or mix the tablet in soy||
7074|049|H|infant formula. Consult your pharmacist for more information.||
7074|050|H|   The dosage is based on your age, weight, medical condition,||
7074|051|H|lab test results, response to treatment, and other medications||
7074|052|H|you may be taking. Be sure to tell your doctor and pharmacist||
7074|053|H|about all the products you use (including prescription drugs,||
7074|054|H|nonprescription drugs, and herbal products).||
7074|055|H|   Use this medication regularly in order to get the most benefit||
7074|056|H|from it. To help you remember, take it at the same time each day.||
7074|057|H|   Do not stop taking this medication without first consulting||
7074|058|H|with your doctor. Thyroid replacement treatment is usually taken||
7074|059|H|for life.||
7074|060|H|   There are different brands of levothyroxine available. Do not||
7074|061|H|change brands without first consulting your doctor or pharmacist.||
7074|062|H|   Certain medications (such as cholestyramine, colestipol,||
7074|063|H|colesevelam, antacids, sucralfate, simethicone, iron, sodium||
7074|064|H|polystyrene sulfonate, calcium supplements, orlistat, sucroferric||
7074|065|H|oxyhydroxide, lanthanum, sevelamer, among others) can decrease||
7074|066|H|the amount of thyroid hormone that is absorbed by your body. If||
7074|067|H|you are taking any of these drugs, separate them from this||
7074|068|H|medication by at least 4 hours.||
7074|069|H|   Symptoms of low thyroid hormone levels include tiredness,||
7074|070|H|muscle aches, constipation, dry skin, weight gain, slow||
7074|071|H|heartbeat, or sensitivity to cold. Tell your doctor if your||
7074|072|H|condition gets worse or lasts after several weeks of taking this||
7074|073|H|medication.||
7074|074|B|||
7074|075|S|SIDE EFFECTS:  See also Precautions section.||
7074|076|S|   Hair loss may occur during the first few months of treatment.||
7074|077|S|This effect is usually temporary as your body adjusts to this||
7074|078|S|medication. If this effect lasts or gets worse, tell your doctor||
7074|079|S|or pharmacist promptly.||
7074|080|S|   Remember that this medication has been prescribed because your||
7074|081|S|doctor has judged that the benefit to you is greater than the||
7074|082|S|risk of side effects. Many people using this medication do not||
7074|083|S|have serious side effects.||
7074|084|S|   Tell your doctor right away if you have any serious effects of||
7074|085|S|high thyroid hormone levels, including: increased sweating,||
7074|086|S|sensitivity to heat, mental/mood changes (such as nervousness,||
7074|087|S|mood swings), tiredness, diarrhea, shaking (tremor), headache,||
7074|088|S|shortness of breath, bone pain, easily broken bones.||
7074|089|S|   Get medical help right away if you have any very serious||
7074|090|S|effects of high thyroid hormone levels, including: chest pain,||
7074|091|S|fast/pounding/irregular heartbeat, swelling hands/ankles/feet,||
7074|092|S|seizures.||
7074|093|S|   A very serious allergic reaction to this drug is rare.||
7074|094|S|However, get medical help right away if you notice any symptoms||
7074|095|S|of a serious allergic reaction, including: rash, itching/swelling||
7074|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7074|097|S|breathing.||
7074|098|S|   This is not a complete list of possible side effects. If you||
7074|099|S|notice other effects not listed above, contact your doctor or||
7074|100|S|pharmacist.||
7074|101|S|   In the US -||
7074|102|S|   Call your doctor for medical advice about side effects. You||
7074|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7074|104|S|www.fda.gov/medwatch.||
7074|105|S|   In Canada - Call your doctor for medical advice about side||
7074|106|S|effects. You may report side effects to Health Canada at||
7074|107|S|1-866-234-2345.||
7074|108|B|||
7074|109|P|PRECAUTIONS:  Before taking levothyroxine, tell your doctor or||
7074|110|P|pharmacist if you are allergic to it; or if you have any other||
7074|111|P|allergies. This product may contain inactive ingredients, which||
7074|112|P|can cause allergic reactions or other problems. Talk to your||
7074|113|P|pharmacist for more details.||
7074|114|P|   Before using this medication, tell your doctor or pharmacist||
7074|115|P|your medical history, especially of: increased thyroid hormones||
7074|116|P|(thyrotoxicosis), decreased adrenal gland function, heart disease||
7074|117|P|(such as coronary artery disease, irregular heartbeat), high||
7074|118|P|blood pressure, diabetes.||
7074|119|P|   If you have diabetes, this drug may affect your blood sugar.||
7074|120|P|Check your blood sugar regularly as directed and share the||
7074|121|P|results with your doctor. Tell your doctor right away if you have||
7074|122|P|symptoms such as increased thirst/urination, shakiness, unusual||
7074|123|P|sweating, dizziness, or hunger. Your doctor may need to adjust||
7074|124|P|your diabetes medication, exercise program, or diet.||
7074|125|P|   Before having surgery, tell your doctor or dentist about all||
7074|126|P|the products you use (including prescription drugs,||
7074|127|P|nonprescription drugs, and herbal products).||
7074|128|P|   Children may be more sensitive to certain side effects of this||
7074|129|P|drug, especially headache, vision changes, and hip/leg pain. High||
7074|130|P|thyroid hormone levels may lead to decreased bone||
7074|131|P|development/growth and reduced full adult height. Keep all||
7074|132|P|lab/medical appointments so the doctor can monitor treatment.||
7074|133|P|   Older adults may be more sensitive to the side effects of this||
7074|134|P|drug, especially fast/pounding/irregular heartbeat.||
7074|135|P|   This drug may be used during pregnancy. Tell your doctor if||
7074|136|P|you are pregnant because your doctor may need to change your||
7074|137|P|dose.||
7074|138|P|   Levothyroxine passes into breast milk but is unlikely to harm||
7074|139|P|a nursing infant. Consult your doctor before breastfeeding.||
7074|140|B|||
7074|141|I|DRUG INTERACTIONS:  See also How to Use Section.||
7074|142|I|   Drug interactions may change how your medications work or||
7074|143|I|increase your risk for serious side effects. This document does||
7074|144|I|not contain all possible drug interactions. Keep a list of all||
7074|145|I|the products you use (including prescription/nonprescription||
7074|146|I|drugs and herbal products) and share it with your doctor and||
7074|147|I|pharmacist. Do not start, stop, or change the dosage of any||
7074|148|I|medicines without your doctor's approval.||
7074|149|B|||
7074|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7074|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7074|152|O|poison control center right away. US residents can call||
7074|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7074|154|O|Symptoms of overdose may include: fast/pounding/irregular||
7074|155|O|heartbeat, loss of consciousness, confusion, seizures.||
7074|156|B|||
7074|157|N|NOTES:  Do not share this medication with others.||
7074|158|N|   Lab and/or medical tests (such as thyroid function) should be||
7074|159|N|done while you are taking this medication. Keep all medical and||
7074|160|N|lab appointments. Consult your doctor for more details.||
7074|161|B|||
7074|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7074|163|D|remember. If it is near the time of the next dose, skip the||
7074|164|D|missed dose. Take your next dose at the regular time. Do not||
7074|165|D|double the dose to catch up unless your doctor tells you to do||
7074|166|D|so. Call your doctor if you miss 2 or more doses in a row. Ask||
7074|167|D|your doctor ahead of time what to do about a missed dose and||
7074|168|D|follow your doctor's specific directions.||
7074|169|B|||
7074|170|R|STORAGE:  Store at room temperature away from light and moisture.||
7074|171|R|Do not store in the bathroom. Keep all medications away from||
7074|172|R|children and pets.||
7074|173|R|   Do not flush medications down the toilet or pour them into a||
7074|174|R|drain unless instructed to do so. Properly discard this product||
7074|175|R|when it is expired or no longer needed. Consult your pharmacist||
7074|176|R|or local waste disposal company.||
7074|177|B|||
7074|178|A|Information last revised May 2024.||
7074|179|A|Copyright(c) 2025 First Databank, Inc.||
7074|180|B|||
7075|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7075|002|Z|does NOT have all possible information about this product. This||
7075|003|Z|information does not assure that this product is safe, effective,||
7075|004|Z|or appropriate for you. This information is not individual||
7075|005|Z|medical advice and does not substitute for the advice of your||
7075|006|Z|health care professional. Always ask your health care||
7075|007|Z|professional for complete information about this product and your||
7075|008|Z|specific health needs.||
7075|009|B|||
7075|010|T|CAPTOPRIL - ORAL||
7075|011|F|(KAP-toe-pril)||
7075|012|B|||
7075|013|C|COMMON BRAND NAME(S): Capoten||
7075|014|B|||
7075|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
7075|016|W|unborn baby if used during pregnancy. It is important to prevent||
7075|017|W|pregnancy while taking this medication. Consult your doctor for||
7075|018|W|more details and to discuss the use of reliable forms of birth||
7075|019|W|control while taking this medication. If you are planning||
7075|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
7075|021|W|your doctor right away.||
7075|022|B|||
7075|023|U|USES:  Captopril is used to treat high blood pressure||
7075|024|U|(hypertension). Lowering high blood pressure helps prevent||
7075|025|U|strokes, heart attacks, and kidney problems. It is also used to||
7075|026|U|treat heart failure, protect the kidneys from harm due to||
7075|027|U|diabetes, and to improve survival after a heart attack.||
7075|028|U|   Captopril is an ACE inhibitor and works by relaxing blood||
7075|029|U|vessels so that blood can flow more easily.||
7075|030|B|||
7075|031|V|OTHER USES:  This section contains uses of this drug that are not||
7075|032|V|listed in the approved professional labeling for the drug but||
7075|033|V|that may be prescribed by your health care professional. Use this||
7075|034|V|drug for a condition that is listed in this section only if it||
7075|035|V|has been so prescribed by your health care professional.||
7075|036|V|   This medication may also be used for kidney disease.||
7075|037|B|||
7075|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7075|039|H|from your pharmacist before you start taking captopril and each||
7075|040|H|time you get a refill. If you have any questions, ask your doctor||
7075|041|H|or pharmacist.||
7075|042|H|   Take this medication by mouth on an empty stomach (at least 1||
7075|043|H|hour before meals) as directed by your doctor, usually two to||
7075|044|H|three times a day.||
7075|045|H|   If you are using the liquid form of this medication, shake the||
7075|046|H|bottle well before each dose. Carefully measure the dose using||
7075|047|H|the special measuring device that is provided. Do not use a||
7075|048|H|household spoon because you may not get the correct dose.||
7075|049|H|   The dosage is based on your medical condition and response to||
7075|050|H|treatment.||
7075|051|H|   Use this medication regularly in order to get the most benefit||
7075|052|H|from it. To help you remember, take it at the same times each||
7075|053|H|day. Keep taking this medication even if you feel well. Most||
7075|054|H|people with high blood pressure do not feel sick.||
7075|055|H|   For the treatment of high blood pressure, it may take up to 2||
7075|056|H|weeks before you get the full benefit of this medication. For the||
7075|057|H|treatment of heart failure, it may take weeks to months before||
7075|058|H|you get the full benefit of this medication. Tell your doctor if||
7075|059|H|your condition does not get better or if it gets worse (for||
7075|060|H|example, your blood pressure readings remain high or increase).||
7075|061|B|||
7075|062|S|SIDE EFFECTS:  Dizziness, lightheadedness, or loss of taste may||
7075|063|S|occur as your body adjusts to the medication. Dry cough may also||
7075|064|S|occur. If any of these effects last or get worse, tell your||
7075|065|S|doctor or pharmacist promptly.||
7075|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
7075|067|S|slowly when rising from a sitting or lying position.||
7075|068|S|   Remember that this medication has been prescribed because your||
7075|069|S|doctor has judged that the benefit to you is greater than the||
7075|070|S|risk of side effects. Many people using this medication do not||
7075|071|S|have serious side effects.||
7075|072|S|   Tell your doctor right away if you have any serious side||
7075|073|S|effects, including: fainting, fast heartbeat, symptoms of a high||
7075|074|S|potassium blood level (such as muscle weakness, slow/irregular||
7075|075|S|heartbeat), signs of infection (such as sore throat that doesn't||
7075|076|S|go away, fever, chills), cloudy urine.||
7075|077|S|   Although captopril may be used to prevent kidney problems or||
7075|078|S|treat people who have kidney problems, it may also rarely cause||
7075|079|S|serious kidney problems or make them worse. Your doctor will||
7075|080|S|check your kidney function while you are taking captopril. Tell||
7075|081|S|your doctor right away if you have any signs of kidney problems||
7075|082|S|such as a change in the amount of urine.||
7075|083|S|   This drug may rarely cause serious (possibly fatal) liver||
7075|084|S|problems. Get medical help right away if you have any symptoms of||
7075|085|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
7075|086|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
7075|087|S|urine.||
7075|088|S|   A very serious allergic reaction to this drug is rare.||
7075|089|S|However, get medical help right away if you notice any symptoms||
7075|090|S|of a serious allergic reaction, including: rash, itching/swelling||
7075|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7075|092|S|breathing.||
7075|093|S|   This is not a complete list of possible side effects. If you||
7075|094|S|notice other effects not listed above, contact your doctor or||
7075|095|S|pharmacist.||
7075|096|S|   In the US -||
7075|097|S|   Call your doctor for medical advice about side effects. You||
7075|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7075|099|S|www.fda.gov/medwatch.||
7075|100|S|   In Canada - Call your doctor for medical advice about side||
7075|101|S|effects. You may report side effects to Health Canada at||
7075|102|S|1-866-234-2345.||
7075|103|B|||
7075|104|P|PRECAUTIONS:  Before taking captopril, tell your doctor or||
7075|105|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
7075|106|P|(such as lisinopril); or if you have any other allergies. This||
7075|107|P|product may contain inactive ingredients, which can cause||
7075|108|P|allergic reactions or other problems. Talk to your pharmacist for||
7075|109|P|more details.||
7075|110|P|   Before using this medication, tell your doctor or pharmacist||
7075|111|P|your medical history, especially of: history of an allergic||
7075|112|P|reaction that included swelling of the face/lips/tongue/throat||
7075|113|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
7075|114|P|dialysis), collagen vascular disease (such as lupus,||
7075|115|P|scleroderma), high level of potassium in the blood.||
7075|116|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7075|117|P|can make you more dizzy. Do not drive, use machinery, or do||
7075|118|P|anything that needs alertness until you can do it safely. Limit||
7075|119|P|alcoholic beverages. Talk to your doctor if you are using||
7075|120|P|marijuana (cannabis).||
7075|121|P|   The liquid form of this medication contains sodium. Ask your||
7075|122|P|doctor or pharmacist for more information if you are on a||
7075|123|P|salt-restricted diet.||
7075|124|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
7075|125|P|and cause you to feel lightheaded. Tell your doctor if you have||
7075|126|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
7075|127|P|of fluids unless your doctor tells you not to.||
7075|128|P|   Before having surgery, tell your doctor or dentist about all||
7075|129|P|the products you use (including prescription drugs,||
7075|130|P|nonprescription drugs, and herbal products).||
7075|131|P|   This product may increase your potassium levels. Before using||
7075|132|P|potassium supplements or salt substitutes that contain potassium,||
7075|133|P|consult your doctor or pharmacist.||
7075|134|P|   Older adults may be more sensitive to the side effects of this||
7075|135|P|drug, including dizziness and increases in potassium level.||
7075|136|P|   Tell your doctor if you are pregnant or plan to become||
7075|137|P|pregnant. You should not become pregnant while using captopril.||
7075|138|P|Captopril may harm an unborn baby. If you become pregnant, talk||
7075|139|P|to your doctor right away about the risks and benefits of this||
7075|140|P|medication. (See also Warning section.)||
7075|141|P|   This medication passes into breast milk but is unlikely to||
7075|142|P|harm a nursing infant. Consult your doctor before breastfeeding.||
7075|143|B|||
7075|144|I|DRUG INTERACTIONS:  See also Precautions section.||
7075|145|I|   Drug interactions may change how your medications work or||
7075|146|I|increase your risk for serious side effects. This document does||
7075|147|I|not contain all possible drug interactions. Keep a list of all||
7075|148|I|the products you use (including prescription/nonprescription||
7075|149|I|drugs and herbal products) and share it with your doctor and||
7075|150|I|pharmacist. Do not start, stop, or change the dosage of any||
7075|151|I|medicines without your doctor's approval.||
7075|152|I|   Some products that may interact with this drug include:||
7075|153|I|aliskiren, certain drugs that weaken the immune system/increase||
7075|154|I|the risk of infection (such as everolimus, sirolimus), lithium,||
7075|155|I|drugs that may increase the level of potassium in the blood (such||
7075|156|I|as ARBs including losartan/valsartan, birth control pills||
7075|157|I|containing drospirenone), sacubitril.||
7075|158|I|   Some products have ingredients that could raise your blood||
7075|159|I|pressure or worsen your heart failure. Tell your pharmacist what||
7075|160|I|products you are using, and ask how to use them safely||
7075|161|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
7075|162|I|ibuprofen/naproxen).||
7075|163|I|   A very serious reaction may occur if you are getting||
7075|164|I|injections for bee/wasp sting allergy (desensitization) and are||
7075|165|I|also taking captopril. Make sure all your doctors know which||
7075|166|I|medicines you are using.||
7075|167|I|   This medication may interfere with certain lab tests (such as||
7075|168|I|acetone urine test), possibly causing false test results. Make||
7075|169|I|sure lab personnel and all your doctors know you use this drug.||
7075|170|B|||
7075|171|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7075|172|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7075|173|O|poison control center right away. US residents can call||
7075|174|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7075|175|O|Symptoms of overdose may include: severe dizziness, fainting,||
7075|176|O|fast heartbeat.||
7075|177|B|||
7075|178|N|NOTES:  Do not share this medication with others.||
7075|179|N|   Lifestyle changes such as stress reduction programs, exercise||
7075|180|N|and dietary changes may increase the effectiveness of this||
7075|181|N|medicine. Talk to your doctor or pharmacist about lifestyle||
7075|182|N|changes that might benefit you.||
7075|183|N|   Lab and/or medical tests (such as kidney function, potassium||
7075|184|N|levels) should be done while you are taking this medication. Keep||
7075|185|N|all medical and lab appointments. Consult your doctor for more||
7075|186|N|details.||
7075|187|N|   Check your blood pressure regularly while taking this||
7075|188|N|medication. Learn how to monitor your own blood pressure at home,||
7075|189|N|and share the results with your doctor.||
7075|190|B|||
7075|191|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7075|192|D|remember. If it is near the time of the next dose, skip the||
7075|193|D|missed dose. Take your next dose at the regular time. Do not||
7075|194|D|double the dose to catch up.||
7075|195|B|||
7075|196|R|STORAGE:  Store at room temperature away from light and moisture.||
7075|197|R|It is normal for the tablets to have a slight sulfur-like odor.||
7075|198|R|Do not store in the bathroom.||
7075|199|R|   Store the liquid form of this medication in an upright||
7075|200|R|position. Do not refrigerate. Once the bottle is opened, this||
7075|201|R|medication expires after 21 days. Keep all medications away from||
7075|202|R|children and pets.||
7075|203|R|   Do not flush medications down the toilet or pour them into a||
7075|204|R|drain unless instructed to do so. Properly discard this product||
7075|205|R|when it is expired or no longer needed. Consult your pharmacist||
7075|206|R|or local waste disposal company.||
7075|207|B|||
7075|208|A|Information last revised March 2025.||
7075|209|A|Copyright(c) 2025 First Databank, Inc.||
7075|210|B|||
7080|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7080|002|Z|does NOT have all possible information about this product. This||
7080|003|Z|information does not assure that this product is safe, effective,||
7080|004|Z|or appropriate for you. This information is not individual||
7080|005|Z|medical advice and does not substitute for the advice of your||
7080|006|Z|health care professional. Always ask your health care||
7080|007|Z|professional for complete information about this product and your||
7080|008|Z|specific health needs.||
7080|009|B|||
7080|010|T|DEXTROAMPHETAMINE SUSTAINED-ACTION CAPSULE - ORAL||
7080|011|F|(DEX-troe-am-FET-a-meen)||
7080|012|B|||
7080|013|C|COMMON BRAND NAME(S): Dexedrine||
7080|014|B|||
7080|015|W|WARNING:  Misuse or abuse of amphetamines may cause serious||
7080|016|W|(possibly fatal) heart and blood pressure problems.||
7080|017|W|Amphetamine-type medications can be habit-forming. Use only as||
7080|018|W|directed. If you use this drug for a long time, you may become||
7080|019|W|dependent on it and may have withdrawal symptoms after stopping||
7080|020|W|the drug. Consult your doctor or pharmacist for more details.||
7080|021|W|(See also How to Use section).||
7080|022|B|||
7080|023|U|USES:  This medication is used to treat attention deficit||
7080|024|U|hyperactivity disorder - ADHD. It works by changing the amounts||
7080|025|U|of certain natural substances in the brain. Dextroamphetamine||
7080|026|U|belongs to a class of drugs known as stimulants. It can help||
7080|027|U|increase your ability to pay attention, stay focused on an||
7080|028|U|activity, and control behavior problems. It may also help you to||
7080|029|U|organize your tasks and improve listening skills.||
7080|030|U|   This drug is also used to treat a certain sleeping disorder||
7080|031|U|(narcolepsy) to help you stay awake during the day. It should not||
7080|032|U|be used to treat tiredness or to hold off sleep in people who do||
7080|033|U|not have a sleep disorder.||
7080|034|B|||
7080|035|H|HOW TO USE:  Read the Medication Guide and, if available, the||
7080|036|H|Patient Information Leaflet provided by your pharmacist before||
7080|037|H|you start taking dextroamphetamine and each time you get a||
7080|038|H|refill. If you have any questions, ask your doctor or pharmacist.||
7080|039|H|   Take this medication by mouth with or without food as directed||
7080|040|H|by your doctor, usually 1-3 times a day. The first dose is||
7080|041|H|usually taken when you wake up in the morning. If more doses are||
7080|042|H|prescribed, take them as directed by your doctor, usually 4-6||
7080|043|H|hours apart. Taking this medication late in the day may cause||
7080|044|H|trouble sleeping (insomnia).||
7080|045|H|   The dosage is based on your medical condition and response to||
7080|046|H|treatment. Your doctor may adjust your dose to find the dose that||
7080|047|H|is best for you. Follow your doctor's instructions carefully.||
7080|048|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
7080|049|H|Doing so can release all of the drug at once, increasing the risk||
7080|050|H|of side effects.||
7080|051|H|   Use this medication regularly to get the most benefit from it.||
7080|052|H|To help you remember, take it at the same time(s) each day.||
7080|053|H|   During treatment, your doctor may occasionally recommend||
7080|054|H|stopping the medication for a short time to see whether there are||
7080|055|H|any changes in your behavior and whether the medication is still||
7080|056|H|needed.||
7080|057|H|   If you suddenly stop using this medication, you may have||
7080|058|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
7080|059|H|mental/mood changes such as depression). To help prevent||
7080|060|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
7080|061|H|more likely if you have used dextroamphetamine for a long time or||
7080|062|H|in high doses. Tell your doctor or pharmacist right away if you||
7080|063|H|have withdrawal.||
7080|064|H|   Though it helps many people, this medication may sometimes||
7080|065|H|cause addiction. This risk may be higher if you have a substance||
7080|066|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
7080|067|H|Do not increase your dose, take it more often, or use it for a||
7080|068|H|longer time than prescribed. Properly stop the medication when so||
7080|069|H|directed.||
7080|070|H|   When this medication is used for a long time, it may not work||
7080|071|H|as well. Talk with your doctor if this medication stops working||
7080|072|H|well.||
7080|073|H|   Tell your doctor if your condition does not get better or if||
7080|074|H|it gets worse.||
7080|075|B|||
7080|076|S|SIDE EFFECTS:  Nausea, stomach upset, cramps, loss of appetite,||
7080|077|S|diarrhea, dry mouth, headache, nervousness, dizziness, trouble||
7080|078|S|sleeping, sweating, weight loss, irritability, and restlessness||
7080|079|S|may occur. If any of these effects last or get worse, tell your||
7080|080|S|doctor or pharmacist promptly.||
7080|081|S|   Remember that this medication has been prescribed because your||
7080|082|S|doctor has judged that the benefit to you is greater than the||
7080|083|S|risk of side effects. Many people using this medication do not||
7080|084|S|have serious side effects.||
7080|085|S|   This medication may raise your blood pressure. Check your||
7080|086|S|blood pressure regularly and tell your doctor if the results are||
7080|087|S|high.||
7080|088|S|   Tell your doctor right away if you have any serious side||
7080|089|S|effects, including: signs of blood flow problems in the fingers||
7080|090|S|or toes (such as coldness, numbness, pain, or skin color||
7080|091|S|changes), unusual wounds on the fingers or toes,||
7080|092|S|mental/mood/behavior changes (such as agitation, aggression, mood||
7080|093|S|swings, depression, hallucinations, abnormal thoughts/behavior,||
7080|094|S|thoughts of suicide), uncontrolled movements, muscle||
7080|095|S|twitching/shaking, outbursts of words/sounds, change in sexual||
7080|096|S|ability/interest, swelling ankles/feet, extreme tiredness,||
7080|097|S|significant unexplained weight loss, frequent/prolonged erections||
7080|098|S|(in males).||
7080|099|S|   Get medical help right away if you have any very serious side||
7080|100|S|effects, including: shortness of breath, chest/jaw/left arm pain,||
7080|101|S|severe headache, fast/pounding/irregular heartbeat, seizures,||
7080|102|S|weakness on one side of the body, trouble speaking, confusion,||
7080|103|S|fainting, blurred vision.||
7080|104|S|   This medication may increase serotonin and rarely cause a very||
7080|105|S|serious condition called serotonin syndrome/toxicity. The risk||
7080|106|S|increases if you are also taking other drugs that increase||
7080|107|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
7080|108|S|take (see Drug Interactions section). Get medical help right away||
7080|109|S|if you develop some of the following symptoms: fast heartbeat,||
7080|110|S|hallucinations, loss of coordination, severe dizziness, severe||
7080|111|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
7080|112|S|unusual agitation/restlessness.||
7080|113|S|   A very serious allergic reaction to this drug is rare.||
7080|114|S|However, get medical help right away if you notice any symptoms||
7080|115|S|of a serious allergic reaction, including: rash, itching/swelling||
7080|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7080|117|S|breathing.||
7080|118|S|   This is not a complete list of possible side effects. If you||
7080|119|S|notice other effects not listed above, contact your doctor or||
7080|120|S|pharmacist.||
7080|121|S|   In the US -||
7080|122|S|   Call your doctor for medical advice about side effects. You||
7080|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7080|124|S|www.fda.gov/medwatch.||
7080|125|S|   In Canada - Call your doctor for medical advice about side||
7080|126|S|effects. You may report side effects to Health Canada at||
7080|127|S|1-866-234-2345.||
7080|128|B|||
7080|129|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
7080|130|P|pharmacist if you are allergic to it; or to other sympathomimetic||
7080|131|P|drugs (such as amphetamine or lisdexamfetamine); or if you have||
7080|132|P|any other allergies. This product may contain inactive||
7080|133|P|ingredients, which can cause allergic reactions or other||
7080|134|P|problems. Talk to your pharmacist for more details.||
7080|135|P|   Before using this medication, tell your doctor or pharmacist||
7080|136|P|your medical history, especially of: blood circulation problems||
7080|137|P|(such as Raynaud's disease), certain mental/mood conditions (such||
7080|138|P|as severe agitation, psychosis), personal/family history of||
7080|139|P|mental/mood disorders (such as bipolar disorder, depression,||
7080|140|P|psychotic disorder, suicidal thoughts), heart problems (including||
7080|141|P|irregular heartbeat/rhythm, coronary artery disease, heart||
7080|142|P|failure, cardiomyopathy, problems with the heart structure such||
7080|143|P|as valve problems), family history of heart problems (such as||
7080|144|P|sudden death/irregular heartbeat/rhythm), history of stroke, high||
7080|145|P|blood pressure, overactive thyroid (hyperthyroidism), history of||
7080|146|P|heart attack or stroke, a certain eye problem (glaucoma),||
7080|147|P|seizures, personal or family history of a substance use disorder||
7080|148|P|(such as overuse of or addiction to drugs/alcohol), personal or||
7080|149|P|family history of uncontrolled muscle movements (such as||
7080|150|P|Tourette's syndrome).||
7080|151|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7080|152|P|can make you more dizzy. Do not drive, use machinery, or do||
7080|153|P|anything that needs alertness until you can do it safely. Limit||
7080|154|P|alcoholic beverages. Talk to your doctor if you are using||
7080|155|P|marijuana (cannabis).||
7080|156|P|   Before having surgery, tell your doctor or dentist about all||
7080|157|P|the products you use (including prescription drugs,||
7080|158|P|nonprescription drugs, and herbal products).||
7080|159|P|   Children (especially those younger than 6) may be more||
7080|160|P|sensitive to the side effects of this drug, especially weight||
7080|161|P|loss. This medication may slow down a child's growth. The doctor||
7080|162|P|may recommend temporarily stopping the medication from time to||
7080|163|P|time to reduce this risk. Monitor your child's weight and height.||
7080|164|P|Consult your doctor or pharmacist for more details.||
7080|165|P|   Older adults may be more sensitive to the side effects of this||
7080|166|P|drug, especially chest pain, trouble sleeping, or weight loss.||
7080|167|P|   During pregnancy, this medication should be used only when||
7080|168|P|clearly needed. Discuss the risks and benefits with your doctor.||
7080|169|P|Infants born to mothers who are dependent on this medication may||
7080|170|P|be born too soon (premature) and have low birth weight. They may||
7080|171|P|also have withdrawal symptoms. Tell your doctor right away if you||
7080|172|P|notice possible mood changes, agitation, or unusual tiredness in||
7080|173|P|your newborn.||
7080|174|P|   This medication passes into breast milk and may have||
7080|175|P|undesirable effects on a nursing infant. Breastfeeding is not||
7080|176|P|recommended while using this medication. Consult your doctor||
7080|177|P|before breastfeeding.||
7080|178|B|||
7080|179|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7080|180|I|medications work or increase your risk for serious side effects.||
7080|181|I|This document does not contain all possible drug interactions.||
7080|182|I|Keep a list of all the products you use (including||
7080|183|I|prescription/nonprescription drugs and herbal products) and share||
7080|184|I|it with your doctor and pharmacist. Do not start, stop, or change||
7080|185|I|the dosage of any medicines without your doctor's approval.||
7080|186|I|   Taking MAO inhibitors with this medication may cause a serious||
7080|187|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
7080|188|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
7080|189|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
7080|190|I|selegiline, tranylcypromine) during treatment with this||
7080|191|I|medication. Most MAO inhibitors should also not be taken for two||
7080|192|I|weeks before treatment with this medication. Ask your doctor when||
7080|193|I|to start or stop taking this medication.||
7080|194|I|   Some products have ingredients that could raise your heart||
7080|195|I|rate or blood pressure. Tell your pharmacist what products you||
7080|196|I|are using, and ask how to use them safely (especially||
7080|197|I|cough-and-cold products or diet aids).||
7080|198|I|   The risk of serotonin syndrome/toxicity increases if you are||
7080|199|I|also taking other drugs that increase serotonin. Examples include||
7080|200|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
7080|201|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
7080|202|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
7080|203|I|serotonin syndrome/toxicity may be more likely when you start or||
7080|204|I|increase the dose of these drugs.||
7080|205|I|   Dextroamphetamine is very similar to amphetamine or||
7080|206|I|lisdexamfetamine. Do not use medications containing amphetamine||
7080|207|I|or lisdexamfetamine while using dextroamphetamine.||
7080|208|I|   This medication may interfere with certain medical/lab tests||
7080|209|I|(such as blood and urine steroid levels, brain scan for||
7080|210|I|Parkinson's disease), possibly causing false test results. Make||
7080|211|I|sure lab personnel and all your doctors know you use this drug.||
7080|212|B|||
7080|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7080|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7080|215|O|poison control center right away. US residents can call||
7080|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7080|217|O|Symptoms of overdose may include: headache that is severe or||
7080|218|O|doesn't go away, severe mental/mood changes, seizures, severe||
7080|219|O|restlessness, fast breathing.||
7080|220|B|||
7080|221|N|NOTES:  Do not share this medication with others. Sharing it is||
7080|222|N|against the law.||
7080|223|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
7080|224|N|growth monitoring in children) may be done while you are taking||
7080|225|N|this medication. Keep all medical and lab appointments. Consult||
7080|226|N|your doctor for more details.||
7080|227|B|||
7080|228|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
7080|229|D|in the morning hours. If it is late in the afternoon or near the||
7080|230|D|time of the next dose, skip the missed dose. Take your next dose||
7080|231|D|at the regular time. Do not double the dose to catch up.||
7080|232|B|||
7080|233|R|STORAGE:  Store at room temperature away from light and moisture.||
7080|234|R|Do not store in the bathroom. Keep all medications away from||
7080|235|R|children and pets.||
7080|236|R|   Do not flush medications down the toilet or pour them into a||
7080|237|R|drain unless instructed to do so. Properly discard this product||
7080|238|R|when it is expired or no longer needed. Consult your pharmacist||
7080|239|R|or local waste disposal company.||
7080|240|B|||
7080|241|A|Information last revised July 2025.||
7080|242|A|Copyright(c) 2025 First Databank, Inc.||
7080|243|B|||
7081|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7081|002|Z|does NOT have all possible information about this product. This||
7081|003|Z|information does not assure that this product is safe, effective,||
7081|004|Z|or appropriate for you. This information is not individual||
7081|005|Z|medical advice and does not substitute for the advice of your||
7081|006|Z|health care professional. Always ask your health care||
7081|007|Z|professional for complete information about this product and your||
7081|008|Z|specific health needs.||
7081|009|B|||
7081|010|T|BUTALBITAL/ACETAMINOPHEN/CAFFEINE - ORAL||
7081|011|F|(bue-TAL-bi-tal/a-SEET-a-MIN-oh-fen/KAF-een)||
7081|012|B|||
7081|013|C|COMMON BRAND NAME(S): Esgic, Fioricet||
7081|014|B|||
7081|015|W|WARNING:  One ingredient in this product is acetaminophen. Taking||
7081|016|W|too much acetaminophen may cause serious (possibly fatal) liver||
7081|017|W|disease. Adults should not take more than 4000 milligrams (4||
7081|018|W|grams) of acetaminophen a day. People with liver problems and||
7081|019|W|children should take less acetaminophen. Ask your doctor or||
7081|020|W|pharmacist how much acetaminophen is safe to take.||
7081|021|W|   Do not use with any other drug containing acetaminophen||
7081|022|W|without asking your doctor or pharmacist first. Acetaminophen is||
7081|023|W|in many nonprescription and prescription medications (such as||
7081|024|W|pain/fever drugs or cough-and-cold products). Check the labels on||
7081|025|W|all your medicines to see if they contain acetaminophen, and ask||
7081|026|W|your pharmacist if you are unsure.||
7081|027|W|   Get medical help right away if you take too much acetaminophen||
7081|028|W|(overdose), even if you feel well. Overdose symptoms may include||
7081|029|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
7081|030|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
7081|031|W|   Daily alcohol use, especially when combined with||
7081|032|W|acetaminophen, may damage your liver. Avoid alcohol.||
7081|033|B|||
7081|034|U|USES:  This combination medication is used to treat tension||
7081|035|U|headaches. Acetaminophen helps to decrease the pain from the||
7081|036|U|headache. Caffeine helps increase the effects of acetaminophen.||
7081|037|U|Butalbital is a sedative that helps to decrease anxiety and cause||
7081|038|U|sleepiness and relaxation.||
7081|039|B|||
7081|040|V|OTHER USES:  This section contains uses of this drug that are not||
7081|041|V|listed in the approved professional labeling for the drug but||
7081|042|V|that may be prescribed by your health care professional. Use this||
7081|043|V|drug for a condition that is listed in this section only if it||
7081|044|V|has been so prescribed by your health care professional.||
7081|045|V|   This drug may also be used for migraine headaches.||
7081|046|B|||
7081|047|H|HOW TO USE:  See also Warning section.||
7081|048|H|   Take this medication by mouth with or without food as directed||
7081|049|H|by your doctor, usually every 4 hours as needed.||
7081|050|H|   If you are using the liquid form of this medication, carefully||
7081|051|H|measure the dose using a special measuring device/spoon. Do not||
7081|052|H|use a household spoon because you may not get the correct dose.||
7081|053|H|   The dosage is based on your medical condition, age, and||
7081|054|H|response to treatment. This medication works best if it is used||
7081|055|H|as the first signs of a headache occur. If you wait until the||
7081|056|H|headache has worsened, the medication may not work as well.||
7081|057|H|   If you suddenly stop using this medication, you may have||
7081|058|H|withdrawal symptoms (such as nausea/vomiting, mental/mood||
7081|059|H|changes, seizures). To help prevent withdrawal, your doctor may||
7081|060|H|lower your dose slowly. Withdrawal is more likely if you have||
7081|061|H|used this medication for a long time or in high doses. Tell your||
7081|062|H|doctor or pharmacist right away if you have withdrawal.||
7081|063|H|   Though it helps many people, this medication may sometimes||
7081|064|H|cause addiction. This risk may be higher if you have a substance||
7081|065|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
7081|066|H|Take this medication exactly as prescribed to lower the risk of||
7081|067|H|addiction. Ask your doctor or pharmacist for more details.||
7081|068|H|   Tell your doctor if you notice increased use of this||
7081|069|H|medication, a worsening of headaches, an increase in the number||
7081|070|H|of headaches, the medication not working as well, or use of this||
7081|071|H|medication for more than 2 headache episodes a week. Do not take||
7081|072|H|more than recommended. Your doctor may need to change your||
7081|073|H|medication and/or add a separate medication to prevent the||
7081|074|H|headaches.||
7081|075|B|||
7081|076|S|SIDE EFFECTS:  See also Warning section.||
7081|077|S|   Nausea, vomiting, abdominal pain, shortness of breath,||
7081|078|S|increased urination, lightheadedness, dizziness, drowsiness, or||
7081|079|S|trouble sleeping may occur. If any of these effects last or get||
7081|080|S|worse, tell your doctor or pharmacist promptly.||
7081|081|S|   To reduce the risk of dizziness and lightheadedness, get up||
7081|082|S|slowly when rising from a sitting or lying position.||
7081|083|S|   Remember that this medication has been prescribed because your||
7081|084|S|doctor has judged that the benefit to you is greater than the||
7081|085|S|risk of side effects. Many people using this medication do not||
7081|086|S|have serious side effects.||
7081|087|S|   Tell your doctor right away if you have any serious side||
7081|088|S|effects, including: mental/mood changes, fainting, seizures,||
7081|089|S|fast/irregular heartbeat.||
7081|090|S|   A very serious allergic reaction to this drug is rare.||
7081|091|S|However, get medical help right away if you notice any symptoms||
7081|092|S|of a serious allergic reaction, including: rash, itching/swelling||
7081|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7081|094|S|breathing.||
7081|095|S|   This is not a complete list of possible side effects. If you||
7081|096|S|notice other effects not listed above, contact your doctor or||
7081|097|S|pharmacist.||
7081|098|S|   In the US -||
7081|099|S|   Call your doctor for medical advice about side effects. You||
7081|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7081|101|S|www.fda.gov/medwatch.||
7081|102|S|   In Canada - Call your doctor for medical advice about side||
7081|103|S|effects. You may report side effects to Health Canada at||
7081|104|S|1-866-234-2345.||
7081|105|B|||
7081|106|P|PRECAUTIONS:  See also Warning section.||
7081|107|P|   Before taking this medication, tell your doctor or pharmacist||
7081|108|P|if you are allergic to acetaminophen, caffeine, or butalbital; or||
7081|109|P|to other barbiturates (such as phenobarbital) or xanthine||
7081|110|P|derivatives (such as theophylline); or if you have any other||
7081|111|P|allergies. This product may contain inactive ingredients, which||
7081|112|P|can cause allergic reactions or other problems. Talk to your||
7081|113|P|pharmacist for more details.||
7081|114|P|   Before using this medication, tell your doctor or pharmacist||
7081|115|P|your medical history, especially of: breathing problems (such as||
7081|116|P|bronchopneumonia), a certain enzyme disorder (porphyria), liver||
7081|117|P|disease, kidney disease, personal or family history of a||
7081|118|P|substance use disorder (such as overuse of or addiction to||
7081|119|P|drugs/alcohol), mental/mood disorders, abdominal/stomach problems||
7081|120|P|(such as stomach ulcer).||
7081|121|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7081|122|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7081|123|P|machinery, or do anything that needs alertness until you can do||
7081|124|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
7081|125|P|are using marijuana (cannabis).||
7081|126|P|   Before having surgery or certain medical procedures (such as a||
7081|127|P|heart stress test or a procedure to restore a normal heart rhythm||
7081|128|P|if you have an unusually fast heartbeat), tell your doctor or||
7081|129|P|dentist that you use this medication and about all the products||
7081|130|P|you use (including prescription drugs, nonprescription drugs, and||
7081|131|P|herbal products).||
7081|132|P|   Older adults may be more sensitive to the side effects of this||
7081|133|P|drug, especially drowsiness and trouble falling asleep. These||
7081|134|P|side effects can increase the risk of falling.||
7081|135|P|   During pregnancy, this medication should be used only when||
7081|136|P|clearly needed. Using it for long periods or in high doses near||
7081|137|P|the expected delivery date is not recommended because of possible||
7081|138|P|harm to the unborn baby. Discuss the risks and benefits with your||
7081|139|P|doctor. Infants born to mothers who have used this medication for||
7081|140|P|an extended time may have withdrawal symptoms such as||
7081|141|P|irritability, abnormal/nonstop crying, vomiting, seizures, or||
7081|142|P|diarrhea. Tell your doctor right away if you notice any of these||
7081|143|P|symptoms in your newborn.||
7081|144|P|   This drug passes into breast milk and could have undesirable||
7081|145|P|effects on a nursing infant. Consult your doctor before||
7081|146|P|breastfeeding.||
7081|147|B|||
7081|148|I|DRUG INTERACTIONS:  See also Warning section.||
7081|149|I|   Drug interactions may change how your medications work or||
7081|150|I|increase your risk for serious side effects. This document does||
7081|151|I|not contain all possible drug interactions. Keep a list of all||
7081|152|I|the products you use (including prescription/nonprescription||
7081|153|I|drugs and herbal products) and share it with your doctor and||
7081|154|I|pharmacist. Do not start, stop, or change the dosage of any||
7081|155|I|medicines without your doctor's approval.||
7081|156|I|   Some products that may interact with this drug include:||
7081|157|I|darunavir, sodium oxybate, isoniazid, ketoconazole,||
7081|158|I|levoketoconazole, lithium, phenothiazines (such as||
7081|159|I|chlorpromazine).||
7081|160|I|   This drug can speed up the removal of other drugs from your||
7081|161|I|body, which may affect how they work. Examples of affected drugs||
7081|162|I|include doxycycline, estrogen, felodipine, lonafarnib, quinidine,||
7081|163|I|rilpivirine, tamoxifen, theophylline, voriconazole, "blood||
7081|164|I|thinners" (such as warfarin), certain beta blockers (such as||
7081|165|I|metoprolol), corticosteroids (such as prednisone), among others.||
7081|166|I|   Tell your doctor or pharmacist if you are taking other||
7081|167|I|products that cause drowsiness such as opioid pain or cough||
7081|168|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7081|169|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
7081|170|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7081|171|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7081|172|I|diphenhydramine).||
7081|173|I|   Check the labels on all your medicines (such as allergy or||
7081|174|I|cough-and-cold products) because they may contain caffeine or||
7081|175|I|ingredients that cause drowsiness. Also keep in mind that certain||
7081|176|I|beverages (such as coffee, colas, tea, energy drinks) contain||
7081|177|I|caffeine. Ask your pharmacist about using those products safely.||
7081|178|I|   This medication may decrease the effectiveness of hormonal||
7081|179|I|birth control such as pills, patch, or ring. This could cause||
7081|180|I|pregnancy. Discuss with your doctor or pharmacist if you should||
7081|181|I|use reliable backup birth control methods while using this||
7081|182|I|medication. Also tell your doctor if you have any new spotting or||
7081|183|I|breakthrough bleeding, because these may be signs that your birth||
7081|184|I|control is not working well.||
7081|185|I|   This medication may interfere with certain medical/lab tests,||
7081|186|I|possibly causing false test results. Make sure lab personnel and||
7081|187|I|all your doctors know you use this drug.||
7081|188|B|||
7081|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7081|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7081|191|O|poison control center right away. US residents can call||
7081|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7081|193|O|Symptoms of overdose may include: severe drowsiness, slow/shallow||
7081|194|O|breathing, severe dizziness, nausea, vomiting, loss of appetite,||
7081|195|O|sweating, stomach/abdominal pain, extreme tiredness, yellowing||
7081|196|O|eyes/skin, dark urine.||
7081|197|B|||
7081|198|N|NOTES:  Do not share this medication with others.||
7081|199|N|   Massage, hot baths, and other relaxation methods can help with||
7081|200|N|tension headaches. Consult your doctor or pharmacist for more||
7081|201|N|details.||
7081|202|N|   Lab and/or medical tests (such as liver/kidney function) may||
7081|203|N|be done while you are taking this medication. Keep all medical||
7081|204|N|and lab appointments. Consult your doctor for more details.||
7081|205|B|||
7081|206|D|MISSED DOSE:  Not applicable.||
7081|207|B|||
7081|208|R|STORAGE:  Store at room temperature away from light and moisture.||
7081|209|R|Do not store in the bathroom. Keep all medications away from||
7081|210|R|children and pets.||
7081|211|R|   Do not flush medications down the toilet or pour them into a||
7081|212|R|drain unless instructed to do so. Properly discard this product||
7081|213|R|when it is expired or no longer needed. Consult your pharmacist||
7081|214|R|or local waste disposal company.||
7081|215|B|||
7081|216|A|Information last revised October 2025.||
7081|217|A|Copyright(c) 2025 First Databank, Inc.||
7081|218|B|||
7083|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7083|002|Z|does NOT have all possible information about this product. This||
7083|003|Z|information does not assure that this product is safe, effective,||
7083|004|Z|or appropriate for you. This information is not individual||
7083|005|Z|medical advice and does not substitute for the advice of your||
7083|006|Z|health care professional. Always ask your health care||
7083|007|Z|professional for complete information about this product and your||
7083|008|Z|specific health needs.||
7083|009|B|||
7083|010|T|CROMOLYN - ORAL||
7083|011|F|(CROW-mow-lin)||
7083|012|B|||
7083|013|C|COMMON BRAND NAME(S): Gastrocrom||
7083|014|B|||
7083|015|U|USES:  This medication is used in people with a food allergy to||
7083|016|U|prevent serious reactions to foods. It is also used to treat and||
7083|017|U|prevent inflammatory bowel diseases (such as ulcerative colitis).||
7083|018|U|Cromolyn belongs to a class of medications called mast cell||
7083|019|U|stabilizers. It works by preventing mast cells (cells involved||
7083|020|U|with allergic/inflammatory reactions) from releasing substances||
7083|021|U|(such as histamines) that can cause skin and gut problems.||
7083|022|B|||
7083|023|H|HOW TO USE:  Take this medication by mouth 15 to 20 minutes||
7083|024|H|before meals as directed by your doctor, usually 4 times daily.||
7083|025|H|   Swallow the capsule whole. If you are taking this medication||
7083|026|H|for food allergy, or if you have trouble swallowing capsules, it||
7083|027|H|is recommended that you take this medication as a solution. When||
7083|028|H|you are ready to take your dose, open the capsule and dissolve||
7083|029|H|the contents into a small amount of hot water. Add cold water,||
7083|030|H|mix, and drink all of the mixture. Do not mix with any other||
7083|031|H|liquid or food. Do not prepare the solution in advance.||
7083|032|H|   The dosage is based on your medical condition, age, and||
7083|033|H|response to treatment.||
7083|034|H|   Use this medication regularly to get the most benefit from it.||
7083|035|H|To help you remember, take it at the same times each day.||
7083|036|H|   Do not suddenly stop taking this medication without consulting||
7083|037|H|your doctor. Your condition may become worse when the drug is||
7083|038|H|suddenly stopped. Your dose may need to be gradually decreased.||
7083|039|H|   Tell your doctor if your condition lasts or gets worse.||
7083|040|B|||
7083|041|S|SIDE EFFECTS:  Nausea, headache, joint pain, or trouble sleeping||
7083|042|S|may occur. If any of these effects last or get worse, tell your||
7083|043|S|doctor or pharmacist promptly.||
7083|044|S|   Remember that this medication has been prescribed because your||
7083|045|S|doctor has judged that the benefit to you is greater than the||
7083|046|S|risk of side effects. Many people using this medication do not||
7083|047|S|have serious side effects.||
7083|048|S|   Tell your doctor right away if you have any serious side||
7083|049|S|effects, including: muscle weakness, unusual tiredness, swelling||
7083|050|S|of the ankles/feet.||
7083|051|S|   A very serious allergic reaction to this drug is rare.||
7083|052|S|However, get medical help right away if you notice any symptoms||
7083|053|S|of a serious allergic reaction, including: rash, itching/swelling||
7083|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7083|055|S|breathing.||
7083|056|S|   This is not a complete list of possible side effects. If you||
7083|057|S|notice other effects not listed above, contact your doctor or||
7083|058|S|pharmacist.||
7083|059|S|   In the US -||
7083|060|S|   Call your doctor for medical advice about side effects. You||
7083|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7083|062|S|www.fda.gov/medwatch.||
7083|063|S|   In Canada - Call your doctor for medical advice about side||
7083|064|S|effects. You may report side effects to Health Canada at||
7083|065|S|1-866-234-2345.||
7083|066|B|||
7083|067|P|PRECAUTIONS:  Before taking cromolyn, tell your doctor or||
7083|068|P|pharmacist if you are allergic to it; or if you have any other||
7083|069|P|allergies. This product may contain inactive ingredients, which||
7083|070|P|can cause allergic reactions or other problems. Talk to your||
7083|071|P|pharmacist for more details.||
7083|072|P|   Before using this medication, tell your doctor or pharmacist||
7083|073|P|your medical history, especially of: kidney disease, liver||
7083|074|P|disease.||
7083|075|P|   Before having surgery, tell your doctor or dentist about all||
7083|076|P|the products you use (including prescription drugs,||
7083|077|P|nonprescription drugs, and herbal products).||
7083|078|P|   During pregnancy, this medication should be used only when||
7083|079|P|clearly needed. Discuss the risks and benefits with your doctor.||
7083|080|P|   It is unknown if this drug passes into breast milk. Consult||
7083|081|P|your doctor before breastfeeding.||
7083|082|B|||
7083|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7083|084|I|medications work or increase your risk for serious side effects.||
7083|085|I|This document does not contain all possible drug interactions.||
7083|086|I|Keep a list of all the products you use (including||
7083|087|I|prescription/nonprescription drugs and herbal products) and share||
7083|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
7083|089|I|the dosage of any medicines without your doctor's approval.||
7083|090|B|||
7083|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7083|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7083|093|O|poison control center right away. US residents can call||
7083|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7083|095|B|||
7083|096|N|NOTES:  Do not share this medication with others.||
7083|097|B|||
7083|098|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7083|099|D|remember. If it is near the time of the next dose, skip the||
7083|100|D|missed dose. Take your next dose at the regular time. Do not||
7083|101|D|double the dose to catch up.||
7083|102|B|||
7083|103|R|STORAGE:  Store at room temperature away from light and moisture.||
7083|104|R|Do not store in the bathroom. Keep all medications away from||
7083|105|R|children and pets.||
7083|106|R|   Do not flush medications down the toilet or pour them into a||
7083|107|R|drain unless instructed to do so. Properly discard this product||
7083|108|R|when it is expired or no longer needed. Consult your pharmacist||
7083|109|R|or local waste disposal company.||
7083|110|B|||
7083|111|A|Information last revised November 2025.||
7083|112|A|Copyright(c) 2025 First Databank, Inc.||
7083|113|B|||
7084|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7084|002|Z|does NOT have all possible information about this product. This||
7084|003|Z|information does not assure that this product is safe, effective,||
7084|004|Z|or appropriate for you. This information is not individual||
7084|005|Z|medical advice and does not substitute for the advice of your||
7084|006|Z|health care professional. Always ask your health care||
7084|007|Z|professional for complete information about this product and your||
7084|008|Z|specific health needs.||
7084|009|B|||
7084|010|T|CLOPIDOGREL - ORAL||
7084|011|F|(kloe-PID-oh-grel)||
7084|012|B|||
7084|013|C|COMMON BRAND NAME(S): Plavix||
7084|014|B|||
7084|015|U|USES:  Clopidogrel is used to prevent heart attacks and strokes||
7084|016|U|in persons with heart disease (recent heart attack), recent||
7084|017|U|stroke, or blood circulation disease (peripheral vascular||
7084|018|U|disease).||
7084|019|U|   It is also used with aspirin to treat new/worsening chest pain||
7084|020|U|(new heart attack, unstable angina) and to keep blood vessels||
7084|021|U|open and prevent blood clots after certain procedures (such as||
7084|022|U|cardiac stent).||
7084|023|U|   Clopidogrel works by blocking platelets from sticking together||
7084|024|U|and prevents them from forming harmful clots. It is an||
7084|025|U|antiplatelet drug. It helps keep blood flowing smoothly in your||
7084|026|U|body.||
7084|027|B|||
7084|028|V|OTHER USES:  This section contains uses of this drug that are not||
7084|029|V|listed in the approved professional labeling for the drug but||
7084|030|V|that may be prescribed by your health care professional. Use this||
7084|031|V|drug for a condition that is listed in this section only if it||
7084|032|V|has been so prescribed by your health care professional.||
7084|033|V|   This drug may also be used to reduce the risk of heart attacks||
7084|034|V|and strokes in people with irregular heartbeat (atrial||
7084|035|V|fibrillation).||
7084|036|B|||
7084|037|H|HOW TO USE:  Read the Medication Guide provided by your||
7084|038|H|pharmacist before you start taking clopidogrel and each time you||
7084|039|H|get a refill. If you have any questions, ask your doctor or||
7084|040|H|pharmacist.||
7084|041|H|   Take this medication by mouth with or without food as directed||
7084|042|H|by your doctor, usually once daily. Take this medication||
7084|043|H|regularly to get the most benefit from it. To help you remember,||
7084|044|H|take it at the same time each day.||
7084|045|H|   The dosage and length of treatment are based on your medical||
7084|046|H|condition and response to treatment. If you are taking this||
7084|047|H|medication to prevent clots after a stent implant or other||
7084|048|H|procedure, take this medication with aspirin for many months to||
7084|049|H|years after the procedure (depending on the procedure/type of||
7084|050|H|stent) as directed by your doctor. Consult your doctor for more||
7084|051|H|details and about the risks of stopping early. Keep taking this||
7084|052|H|medication even if you feel well. Do not stop taking this||
7084|053|H|medication without consulting your doctor.||
7084|054|H|   Avoid eating grapefruit or drinking grapefruit juice while||
7084|055|H|using this medication unless your doctor or pharmacist says you||
7084|056|H|may do so safely. Grapefruit can increase the chance of side||
7084|057|H|effects with this medicine. Ask your doctor or pharmacist for||
7084|058|H|more details.||
7084|059|H|   Get medical help right away if you have any signs that this||
7084|060|H|medication is not working, such as symptoms of a new heart attack||
7084|061|H|or stroke (such as chest/jaw/left arm pain, shortness of breath,||
7084|062|H|unusual sweating, weakness on one side of the body, trouble||
7084|063|H|speaking, sudden vision changes, confusion).||
7084|064|B|||
7084|065|S|SIDE EFFECTS:  Easy bleeding/bruising, stomach upset/pain,||
7084|066|S|diarrhea, and constipation may occur. If any of these effects||
7084|067|S|last or get worse, tell your doctor or pharmacist promptly.||
7084|068|S|   Remember that this medication has been prescribed because your||
7084|069|S|doctor has judged that the benefit to you is greater than the||
7084|070|S|risk of side effects. Many people using this medication do not||
7084|071|S|have serious side effects.||
7084|072|S|   Although unlikely, serious bleeding in the stomach, gut, eyes,||
7084|073|S|or brain may occur. Also, clopidogrel can rarely cause a very||
7084|074|S|serious blood disorder (thrombotic thrombocytopenic purpura-TTP).||
7084|075|S|Symptoms may appear any time after starting this medication. Get||
7084|076|S|medical help right away if any of these symptoms occur: severe||
7084|077|S|stomach/abdominal pain, uncontrolled bleeding from gums or nose,||
7084|078|S|bloody/black stools, confusion, fever, extreme skin paleness,||
7084|079|S|purple skin patches, fainting, fast heartbeat, sudden severe||
7084|080|S|headache, unusual weakness/tiredness, vomit with blood or that||
7084|081|S|looks like coffee grounds, trouble speaking, vision changes,||
7084|082|S|seizures, yellowing eyes/skin, bloody/red/pink/dark urine, signs||
7084|083|S|of kidney problems (such as change in the amount of urine).||
7084|084|S|   A very serious allergic reaction to this drug is rare.||
7084|085|S|However, get medical help right away if you notice any symptoms||
7084|086|S|of a serious allergic reaction, including: rash, itching/swelling||
7084|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7084|088|S|breathing.||
7084|089|S|   This is not a complete list of possible side effects. If you||
7084|090|S|notice other effects not listed above, contact your doctor or||
7084|091|S|pharmacist.||
7084|092|S|   In the US -||
7084|093|S|   Call your doctor for medical advice about side effects. You||
7084|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7084|095|S|www.fda.gov/medwatch.||
7084|096|S|   In Canada - Call your doctor for medical advice about side||
7084|097|S|effects. You may report side effects to Health Canada at||
7084|098|S|1-866-234-2345.||
7084|099|B|||
7084|100|P|PRECAUTIONS:  Before taking clopidogrel, tell your doctor or||
7084|101|P|pharmacist if you are allergic to it; or to similar antiplatelet||
7084|102|P|drugs (thienopyridines such as prasugrel); or if you have any||
7084|103|P|other allergies. This product may contain inactive ingredients,||
7084|104|P|which can cause allergic reactions or other problems. Talk to||
7084|105|P|your pharmacist for more details.||
7084|106|P|   Before using this medication, tell your doctor or pharmacist||
7084|107|P|your medical history, especially of: bleeding conditions (such as||
7084|108|P|stomach ulcers, bleeding in the brain/eye), recent surgery,||
7084|109|P|serious injury/trauma, liver disease, bleeding disease (such as||
7084|110|P|hemophilia).||
7084|111|P|   To lower the chance of getting cut, bruised, or injured, use||
7084|112|P|caution with sharp objects like razors and nail cutters, and||
7084|113|P|avoid activities such as contact sports.||
7084|114|P|   Before having surgery, tell your doctor or dentist about all||
7084|115|P|the products you use (including prescription drugs,||
7084|116|P|nonprescription drugs, and herbal products). Your doctor may||
7084|117|P|instruct you to stop clopidogrel for at least 5 days before||
7084|118|P|surgery. Do not stop taking clopidogrel without talking with your||
7084|119|P|heart doctor (cardiologist) first.||
7084|120|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
7084|121|P|while using this medicine may increase your risk for stomach||
7084|122|P|bleeding. Limit alcoholic beverages. Ask your doctor or||
7084|123|P|pharmacist about how much alcohol you may safely drink.||
7084|124|P|   During pregnancy, this medication should be used only when||
7084|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
7084|126|P|   It is unknown if this drug passes into breast milk. Consult||
7084|127|P|your doctor before breastfeeding.||
7084|128|B|||
7084|129|I|DRUG INTERACTIONS:  See also How to Use section.||
7084|130|I|   Drug interactions may change how your medications work or||
7084|131|I|increase your risk for serious side effects. This document does||
7084|132|I|not contain all possible drug interactions. Keep a list of all||
7084|133|I|the products you use (including prescription/nonprescription||
7084|134|I|drugs and herbal products) and share it with your doctor and||
7084|135|I|pharmacist. Do not start, stop, or change the dosage of any||
7084|136|I|medicines without your doctor's approval.||
7084|137|I|   A product that may interact with this drug is: tipranavir.||
7084|138|I|   If you are currently taking aspirin, consult your doctor||
7084|139|I|promptly and ask whether to continue or stop taking it with this||
7084|140|I|medication for your specific condition (aspirin and clopidogrel||
7084|141|I|may be used in combination after a coronary stent procedure, or||
7084|142|I|for some heart conditions). If you are not currently taking||
7084|143|I|aspirin, consult your doctor before starting it for any medical||
7084|144|I|condition.||
7084|145|I|   Other medications can affect the removal of clopidogrel from||
7084|146|I|your body, which may affect how clopidogrel works. Examples||
7084|147|I|include certain acid reducers (proton pump inhibitors/PPIs such||
7084|148|I|as omeprazole, esomeprazole), cimetidine, etravirine, felbamate,||
7084|149|I|fluconazole, fluoxetine, fluvoxamine, ketoconazole, rifampin,||
7084|150|I|voriconazole, among others.||
7084|151|I|   Clopidogrel can slow down the removal of other drugs from your||
7084|152|I|body, which may affect how they work. Examples of affected drugs||
7084|153|I|include repaglinide, tovorafenib, among others.||
7084|154|I|   Check all prescription and nonprescription medicine labels||
7084|155|I|carefully since many medications contain pain relievers/fever||
7084|156|I|reducers (NSAIDs such as ibuprofen, naproxen, or aspirin). These||
7084|157|I|drugs may increase the risk of bleeding/antiplatelet effect when||
7084|158|I|used with clopidogrel. Ask your pharmacist about using these||
7084|159|I|products safely.||
7084|160|B|||
7084|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7084|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7084|163|O|poison control center right away. US residents can call||
7084|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7084|165|B|||
7084|166|N|NOTES:  Do not share this medication with others.||
7084|167|N|   Lab and/or medical tests (such as complete blood count) may be||
7084|168|N|done while you are taking this medication. Keep all medical and||
7084|169|N|lab appointments. Consult your doctor for more details.||
7084|170|B|||
7084|171|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7084|172|D|remember. If it is near the time of the next dose, skip the||
7084|173|D|missed dose. Take your next dose at the regular time. Do not||
7084|174|D|double the dose to catch up.||
7084|175|B|||
7084|176|R|STORAGE:  Store at room temperature away from light and moisture.||
7084|177|R|Do not store in the bathroom. Keep all medications away from||
7084|178|R|children and pets.||
7084|179|R|   Do not flush medications down the toilet or pour them into a||
7084|180|R|drain unless instructed to do so. Properly discard this product||
7084|181|R|when it is expired or no longer needed. Consult your pharmacist||
7084|182|R|or local waste disposal company.||
7084|183|B|||
7084|184|M|MEDICAL ALERT:  Your condition can cause complications in a||
7084|185|M|medical emergency. For information about enrolling in MedicAlert,||
7084|186|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7084|187|B|||
7084|188|A|Information last revised April 2025.||
7084|189|A|Copyright(c) 2025 First Databank, Inc.||
7084|190|B|||
7085|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7085|002|Z|does NOT have all possible information about this product. This||
7085|003|Z|information does not assure that this product is safe, effective,||
7085|004|Z|or appropriate for you. This information is not individual||
7085|005|Z|medical advice and does not substitute for the advice of your||
7085|006|Z|health care professional. Always ask your health care||
7085|007|Z|professional for complete information about this product and your||
7085|008|Z|specific health needs.||
7085|009|B|||
7085|010|T|PROPAFENONE EXTENDED-RELEASE - ORAL||
7085|011|F|(pro-puh-FEN-own)||
7085|012|B|||
7085|013|C|COMMON BRAND NAME(S): Rythmol SR||
7085|014|B|||
7085|015|W|WARNING:  Though this medication often gives great benefits to||
7085|016|W|people with irregular heartbeat, it may rarely cause a serious||
7085|017|W|new irregular heartbeat. Talk with your doctor about the benefits||
7085|018|W|and risks of taking this medication.||
7085|019|B|||
7085|020|U|USES:  This medication is used to help prevent certain types of||
7085|021|U|serious (possibly fatal) irregular heartbeat (such as paroxysmal||
7085|022|U|supraventricular tachycardia and atrial fibrillation). It is used||
7085|023|U|to help maintain a regular, steady heartbeat. Propafenone is||
7085|024|U|known as an anti-arrhythmic drug. It works by blocking the||
7085|025|U|activity of certain electrical signals in the heart that can||
7085|026|U|cause an irregular heartbeat. Treating an irregular heartbeat can||
7085|027|U|decrease the risk for blood clots, and this effect can reduce||
7085|028|U|your risk of heart attack or stroke.||
7085|029|B|||
7085|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7085|031|H|from your pharmacist before you start taking propafenone||
7085|032|H|extended-release capsules and each time you get a refill. If you||
7085|033|H|have any questions, ask your doctor or pharmacist.||
7085|034|H|   Take this medication by mouth with or without food as directed||
7085|035|H|by your doctor, usually every 12 hours. Swallow the capsules||
7085|036|H|whole. Do not crush or chew the capsules. Doing so can release||
7085|037|H|all of the drug at once, increasing the risk of side effects.||
7085|038|H|   The dosage is based on your medical condition and response to||
7085|039|H|treatment.||
7085|040|H|   Use this medication regularly to get the most benefit from it.||
7085|041|H|To help you remember, take it at the same times each day.||
7085|042|H|   Avoid eating grapefruit or drinking grapefruit juice while||
7085|043|H|using this medication unless your doctor or pharmacist says you||
7085|044|H|may do so safely. Grapefruit can increase the chance of side||
7085|045|H|effects with this medicine. Ask your doctor or pharmacist for||
7085|046|H|more details.||
7085|047|H|   Tell your doctor if your condition does not get better or if||
7085|048|H|it gets worse.||
7085|049|B|||
7085|050|S|SIDE EFFECTS:  See also Warning section.||
7085|051|S|   Dizziness, headache, metallic/salty taste in the mouth,||
7085|052|S|nausea/vomiting, constipation, anxiety, and tiredness may occur.||
7085|053|S|If any of these effects last or get worse, tell your doctor or||
7085|054|S|pharmacist promptly.||
7085|055|S|   Remember that this medication has been prescribed because your||
7085|056|S|doctor has judged that the benefit to you is greater than the||
7085|057|S|risk of side effects. Many people using this medication do not||
7085|058|S|have serious side effects.||
7085|059|S|   Tell your doctor right away if you have any serious side||
7085|060|S|effects, including: signs of infection (such as sore throat that||
7085|061|S|doesn't go away, fever, chills), signs of liver problems (such as||
7085|062|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
7085|063|S|yellowing eyes/skin, dark urine), worsening symptoms of heart||
7085|064|S|failure (such as shortness of breath, swelling ankles/feet,||
7085|065|S|unusual tiredness, unusual/sudden weight gain).||
7085|066|S|   Get medical help right away if you have any very serious side||
7085|067|S|effects, including: fainting, faster/more irregular heartbeat,||
7085|068|S|severe dizziness.||
7085|069|S|   A very serious allergic reaction to this drug is rare.||
7085|070|S|However, get medical help right away if you notice any symptoms||
7085|071|S|of a serious allergic reaction, including: rash, itching/swelling||
7085|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7085|073|S|breathing.||
7085|074|S|   This is not a complete list of possible side effects. If you||
7085|075|S|notice other effects not listed above, contact your doctor or||
7085|076|S|pharmacist.||
7085|077|S|   In the US -||
7085|078|S|   Call your doctor for medical advice about side effects. You||
7085|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7085|080|S|www.fda.gov/medwatch.||
7085|081|S|   In Canada - Call your doctor for medical advice about side||
7085|082|S|effects. You may report side effects to Health Canada at||
7085|083|S|1-866-234-2345.||
7085|084|B|||
7085|085|P|PRECAUTIONS:  Before taking propafenone, tell your doctor or||
7085|086|P|pharmacist if you are allergic to it; or if you have any other||
7085|087|P|allergies. This product may contain inactive ingredients, which||
7085|088|P|can cause allergic reactions or other problems. Talk to your||
7085|089|P|pharmacist for more details.||
7085|090|P|   Before using this medication, tell your doctor or pharmacist||
7085|091|P|your medical history, especially of: breathing problems (such as||
7085|092|P|asthma, chronic bronchitis, emphysema), kidney problems, liver||
7085|093|P|problems, myasthenia gravis, a certain inherited heart condition||
7085|094|P|(Brugada Syndrome).||
7085|095|P|   Propafenone may cause a condition that affects the heart||
7085|096|P|rhythm (QT prolongation). QT prolongation can rarely cause||
7085|097|P|serious (rarely fatal) fast/irregular heartbeat and other||
7085|098|P|symptoms (such as severe dizziness, fainting) that need medical||
7085|099|P|attention right away.||
7085|100|P|   The risk of QT prolongation may be increased if you have||
7085|101|P|certain medical conditions or are taking other drugs that may||
7085|102|P|cause QT prolongation. Before using propafenone, tell your doctor||
7085|103|P|or pharmacist of all the drugs you take and if you have any of||
7085|104|P|the following conditions: certain heart problems (heart failure,||
7085|105|P|slow heartbeat, QT prolongation in the EKG), family history of||
7085|106|P|certain heart problems (QT prolongation in the EKG, sudden||
7085|107|P|cardiac death).||
7085|108|P|   Low levels of potassium or magnesium in the blood may also||
7085|109|P|increase your risk of QT prolongation. This risk may increase if||
7085|110|P|you use certain drugs (such as diuretics/"water pills") or if you||
7085|111|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7085|112|P|Talk to your doctor about using propafenone safely.||
7085|113|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7085|114|P|can make you more dizzy. Do not drive, use machinery, or do||
7085|115|P|anything that needs alertness until you can do it safely. Limit||
7085|116|P|alcoholic beverages. Talk to your doctor if you are using||
7085|117|P|marijuana (cannabis).||
7085|118|P|   Before having surgery, tell your doctor or dentist about all||
7085|119|P|the products you use (including prescription drugs,||
7085|120|P|nonprescription drugs, and herbal products).||
7085|121|P|   Older adults may be more sensitive to the side effects of this||
7085|122|P|drug, especially QT prolongation (see above).||
7085|123|P|   This medication can affect fertility in males. Ask your doctor||
7085|124|P|for more details.||
7085|125|P|   During pregnancy, this medication should be used only when||
7085|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
7085|127|P|   This medication passes into breast milk. Consult your doctor||
7085|128|P|before breastfeeding.||
7085|129|B|||
7085|130|I|DRUG INTERACTIONS:  See also How to Use section.||
7085|131|I|   Drug interactions may change how your medications work or||
7085|132|I|increase your risk for serious side effects. This document does||
7085|133|I|not contain all possible drug interactions. Keep a list of all||
7085|134|I|the products you use (including prescription/nonprescription||
7085|135|I|drugs and herbal products) and share it with your doctor and||
7085|136|I|pharmacist. Do not start, stop, or change the dosage of any||
7085|137|I|medicines without your doctor's approval.||
7085|138|I|   Many drugs besides propafenone may affect the heart rhythm (QT||
7085|139|I|prolongation), including amiodarone, dofetilide, flecainide,||
7085|140|I|pimozide, procainamide, quinidine, sotalol, macrolide antibiotics||
7085|141|I|(such as erythromycin), among others.||
7085|142|I|   Other medications can affect the removal of propafenone from||
7085|143|I|your body, which may affect how propafenone works. Examples||
7085|144|I|include desipramine, ketoconazole, orlistat, phenobarbital,||
7085|145|I|phenytoin, ritonavir, certain HIV protease inhibitors (such as||
7085|146|I|tipranavir), among others.||
7085|147|I|   Propafenone can slow down the removal of other medications||
7085|148|I|from your body, which may affect how they work. Examples of||
7085|149|I|affected drugs include digoxin, fezolinetant, imipramine,||
7085|150|I|metoprolol, propranolol, warfarin, among others.||
7085|151|B|||
7085|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7085|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7085|154|O|poison control center right away. US residents can call||
7085|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7085|156|O|Symptoms of overdose may include: severe dizziness, very slow||
7085|157|O|heartbeat, new irregular heartbeat, fainting.||
7085|158|B|||
7085|159|N|NOTES:  Do not share this medication with others.||
7085|160|N|   Lab and/or medical tests (such as EKG) should be done while||
7085|161|N|you are taking this medication. Keep all medical and lab||
7085|162|N|appointments. Consult your doctor for more details.||
7085|163|B|||
7085|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7085|165|D|remember. If it is near the time of the next dose, skip the||
7085|166|D|missed dose. Take your next dose at the regular time. Do not||
7085|167|D|double the dose to catch up.||
7085|168|B|||
7085|169|R|STORAGE:  Store at room temperature away from light and moisture.||
7085|170|R|Do not store in the bathroom. Keep all medications away from||
7085|171|R|children and pets.||
7085|172|R|   Do not flush medications down the toilet or pour them into a||
7085|173|R|drain unless instructed to do so. Properly discard this product||
7085|174|R|when it is expired or no longer needed. Consult your pharmacist||
7085|175|R|or local waste disposal company.||
7085|176|B|||
7085|177|M|MEDICAL ALERT:  Your condition can cause complications in a||
7085|178|M|medical emergency. For information about enrolling in MedicAlert,||
7085|179|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7085|180|B|||
7085|181|A|Information last revised July 2025.||
7085|182|A|Copyright(c) 2025 First Databank, Inc.||
7085|183|B|||
7087|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7087|002|Z|does NOT have all possible information about this product. This||
7087|003|Z|information does not assure that this product is safe, effective,||
7087|004|Z|or appropriate for you. This information is not individual||
7087|005|Z|medical advice and does not substitute for the advice of your||
7087|006|Z|health care professional. Always ask your health care||
7087|007|Z|professional for complete information about this product and your||
7087|008|Z|specific health needs.||
7087|009|B|||
7087|010|T|BACLOFEN - ORAL||
7087|011|F|(BAK-loe-fen)||
7087|012|B|||
7087|013|C|COMMON BRAND NAME(S): Fleqsuvy, Lioresal, Lyvispah, Ozobax||
7087|014|B|||
7087|015|U|USES:  Baclofen is used to treat muscle spasms caused by certain||
7087|016|U|conditions (such as multiple sclerosis, spinal cord||
7087|017|U|injury/disease). It works by helping to relax the muscles.||
7087|018|B|||
7087|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7087|020|H|from your pharmacist before you start taking baclofen and each||
7087|021|H|time you get a refill. If you have any questions, ask your doctor||
7087|022|H|or pharmacist.||
7087|023|H|   Take this medication by mouth with or without food as directed||
7087|024|H|by your doctor, usually 3 times a day. To reduce your risk of||
7087|025|H|side effects, your doctor may direct you to start this medication||
7087|026|H|at a low dose and gradually increase your dose. Follow your||
7087|027|H|doctor's instructions carefully.||
7087|028|H|   If you are using the liquid form of this medication, carefully||
7087|029|H|measure the dose using a special measuring device/spoon. Do not||
7087|030|H|use a household spoon because you may not get the correct dose.||
7087|031|H|If your liquid form is a suspension, shake the bottle well before||
7087|032|H|each dose.||
7087|033|H|   If you are taking the granules form of this medication, gently||
7087|034|H|shake the packet before use. Open the packet and empty the entire||
7087|035|H|contents of the packet into your mouth and swallow. You may drink||
7087|036|H|water after swallowing the granules if needed. You may also mix||
7087|037|H|the contents of each packet with 1 tablespoonful (15 milliliters)||
7087|038|H|of soft food or liquid (such as yogurt, applesauce, pudding,||
7087|039|H|milk, or apple juice). After mixing, take all of the mixture||
7087|040|H|within 2 hours. If you are using more than 1 packet, mix each||
7087|041|H|packet in a separate amount of soft food or liquid.||
7087|042|H|   The dosage is based on your medical condition and response to||
7087|043|H|treatment. Do not increase your dose or take it more often than||
7087|044|H|prescribed.||
7087|045|H|   Use this medication regularly to get the most benefit from it.||
7087|046|H|To help you remember, take it at the same times each day. Do not||
7087|047|H|stop taking this medication without consulting your doctor. Some||
7087|048|H|conditions may become worse when this drug is suddenly stopped.||
7087|049|H|If you suddenly stop using this medication, you may also have||
7087|050|H|withdrawal symptoms (such as hallucinations and seizures). To||
7087|051|H|help prevent withdrawal, your doctor may lower your dose slowly.||
7087|052|H|Withdrawal is more likely if you have used baclofen for a long||
7087|053|H|time or in high doses. Tell your doctor or pharmacist right away||
7087|054|H|if you have withdrawal.||
7087|055|H|   Tell your doctor if your condition does not get better or if||
7087|056|H|it gets worse.||
7087|057|B|||
7087|058|S|SIDE EFFECTS:  Drowsiness, dizziness, weakness, tiredness,||
7087|059|S|headache, trouble sleeping, nausea, increased urination, or||
7087|060|S|constipation may occur. If any of these effects last or get||
7087|061|S|worse, tell your doctor or pharmacist promptly.||
7087|062|S|   Remember that this medication has been prescribed because your||
7087|063|S|doctor has judged that the benefit to you is greater than the||
7087|064|S|risk of side effects. Many people using this medication do not||
7087|065|S|have serious side effects.||
7087|066|S|   Tell your doctor right away if you have any serious side||
7087|067|S|effects, including: mental/mood changes (such as confusion,||
7087|068|S|depression, hallucinations).||
7087|069|S|   A very serious allergic reaction to this drug is rare.||
7087|070|S|However, get medical help right away if you notice any symptoms||
7087|071|S|of a serious allergic reaction, including: rash, itching/swelling||
7087|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7087|073|S|breathing.||
7087|074|S|   This is not a complete list of possible side effects. If you||
7087|075|S|notice other effects not listed above, contact your doctor or||
7087|076|S|pharmacist.||
7087|077|S|   In the US -||
7087|078|S|   Call your doctor for medical advice about side effects. You||
7087|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7087|080|S|www.fda.gov/medwatch.||
7087|081|S|   In Canada - Call your doctor for medical advice about side||
7087|082|S|effects. You may report side effects to Health Canada at||
7087|083|S|1-866-234-2345.||
7087|084|B|||
7087|085|P|PRECAUTIONS:  Before taking baclofen, tell your doctor or||
7087|086|P|pharmacist if you are allergic to it; or if you have any other||
7087|087|P|allergies. This product may contain inactive ingredients, which||
7087|088|P|can cause allergic reactions or other problems. Talk to your||
7087|089|P|pharmacist for more details.||
7087|090|P|   Before using this medication, tell your doctor or pharmacist||
7087|091|P|your medical history, especially of: kidney disease, mental/mood||
7087|092|P|disorders (such as schizophrenia), brain disorders (such as||
7087|093|P|seizures, stroke).||
7087|094|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7087|095|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7087|096|P|machinery, or do anything that needs alertness until you can do||
7087|097|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
7087|098|P|are using marijuana (cannabis).||
7087|099|P|   Before having surgery, tell your doctor or dentist about all||
7087|100|P|the products you use (including prescription drugs,||
7087|101|P|nonprescription drugs, and herbal products).||
7087|102|P|   Older adults may be more sensitive to the side effects of this||
7087|103|P|drug, especially drowsiness and mental/mood changes (such as||
7087|104|P|confusion).||
7087|105|P|   During pregnancy, this medication should be used only when||
7087|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
7087|107|P|Babies born to mothers who have used this drug during pregnancy||
7087|108|P|may rarely develop withdrawal symptoms such as tremor or||
7087|109|P|seizures. If you notice any of these symptoms in your newborn,||
7087|110|P|tell the doctor right away.||
7087|111|P|   This drug passes into breast milk. Consult your doctor before||
7087|112|P|breastfeeding.||
7087|113|B|||
7087|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7087|115|I|medications work or increase your risk for serious side effects.||
7087|116|I|This document does not contain all possible drug interactions.||
7087|117|I|Keep a list of all the products you use (including||
7087|118|I|prescription/nonprescription drugs and herbal products) and share||
7087|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
7087|120|I|the dosage of any medicines without your doctor's approval.||
7087|121|I|   Tell your doctor or pharmacist if you are taking other||
7087|122|I|products that cause drowsiness such as opioid pain or cough||
7087|123|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7087|124|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
7087|125|I|lorazepam, zolpidem), other muscle relaxants (such as||
7087|126|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
7087|127|I|cetirizine, diphenhydramine).||
7087|128|I|   Check the labels on all your medicines (such as allergy or||
7087|129|I|cough-and-cold products) because they may contain ingredients||
7087|130|I|that cause drowsiness. Ask your pharmacist about using those||
7087|131|I|products safely.||
7087|132|B|||
7087|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7087|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7087|135|O|poison control center right away. US residents can call||
7087|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7087|137|O|Symptoms of overdose may include: vomiting, severe drowsiness,||
7087|138|O|slow/shallow breathing, seizures.||
7087|139|B|||
7087|140|N|NOTES:  Do not share this medication with others.||
7087|141|N|   This medication has been prescribed for your current condition||
7087|142|N|only. Do not use it later for another condition unless your||
7087|143|N|doctor directs you to do so. A different medication may be||
7087|144|N|necessary in that case.||
7087|145|B|||
7087|146|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7087|147|D|remember. If it is near the time of the next dose, skip the||
7087|148|D|missed dose. Take your next dose at the regular time. Do not||
7087|149|D|double the dose to catch up.||
7087|150|B|||
7087|151|R|STORAGE:  Store the tablet and granules form of this medication||
7087|152|R|at room temperature away from light and moisture. Do not store in||
7087|153|R|the bathroom. Keep all medications away from children and pets.||
7087|154|R|   Different brands of the liquid form of this medication have||
7087|155|R|different storage needs. Check the product package for||
7087|156|R|instructions on how to store your brand, or ask your pharmacist.||
7087|157|R|   Do not flush medications down the toilet or pour them into a||
7087|158|R|drain unless instructed to do so. Properly discard this product||
7087|159|R|when it is expired or no longer needed. Consult your pharmacist||
7087|160|R|or local waste disposal company.||
7087|161|B|||
7087|162|A|Information last revised May 2024.||
7087|163|A|Copyright(c) 2025 First Databank, Inc.||
7087|164|B|||
7088|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7088|002|Z|does NOT have all possible information about this product. This||
7088|003|Z|information does not assure that this product is safe, effective,||
7088|004|Z|or appropriate for you. This information is not individual||
7088|005|Z|medical advice and does not substitute for the advice of your||
7088|006|Z|health care professional. Always ask your health care||
7088|007|Z|professional for complete information about this product and your||
7088|008|Z|specific health needs.||
7088|009|B|||
7088|010|T|BACITRACIN - OPHTHALMIC||
7088|011|F|(BAS-i-TRAY-sin)||
7088|012|B|||
7088|013|C|COMMON BRAND NAME(S): Baciguent||
7088|014|B|||
7088|015|U|USES:  This medication is an antibiotic used to treat certain||
7088|016|U|bacterial eye infections. It works by stopping the growth of||
7088|017|U|bacteria.||
7088|018|U|   This medication treats only bacterial eye infections. It will||
7088|019|U|not work for other types of eye infections. Unnecessary use or||
7088|020|U|overuse of any antibiotic can lead to its decreased||
7088|021|U|effectiveness.||
7088|022|B|||
7088|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
7088|024|H|directed by your doctor, usually 1 to 3 times daily.||
7088|025|H|   Do not wear contact lenses while you are using this medicine.||
7088|026|H|Sterilize contact lenses according to manufacturer's directions,||
7088|027|H|and check with your doctor before you begin using them again.||
7088|028|H|   To apply eye ointments, wash hands first. To avoid||
7088|029|H|contamination, do not touch the tube tip or let it touch your eye||
7088|030|H|or any other surface. Tilt your head back, look upward, and||
7088|031|H|gently pull down the lower eyelid to make a pouch. Place a 1/4 to||
7088|032|H|1/2 inch (0.5 to 1.5 centimeter) strip of ointment into the||
7088|033|H|pouch. Gently close the eye and roll the eyeball in all||
7088|034|H|directions to spread the medication. Try not to blink and do not||
7088|035|H|rub the eye. Repeat these steps for your other eye if so||
7088|036|H|directed.||
7088|037|H|   If you are treating an infection of the eyelid, first clean||
7088|038|H|all scales and crusts away from the area before applying the eye||
7088|039|H|ointment on the eyelid.||
7088|040|H|   Wipe the tip of the ointment tube with a clean tissue to||
7088|041|H|remove extra medication before recapping it.||
7088|042|H|   If you are using another kind of eye medication (such as drops||
7088|043|H|or ointments), wait at least 5 to 10 minutes before applying||
7088|044|H|other medications. Use eye drops before eye ointments to allow||
7088|045|H|the drops to enter the eye.||
7088|046|H|   Wait several minutes for your vision to clear before driving||
7088|047|H|or operating machinery.||
7088|048|H|   Use this medication regularly in order to get the most benefit||
7088|049|H|from it. To help you remember, use it at the same time(s) each||
7088|050|H|day.||
7088|051|H|   Tell your doctor if your condition lasts or gets worse.||
7088|052|B|||
7088|053|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
7088|054|S|because your doctor has judged that the benefit to you is greater||
7088|055|S|than the risk of side effects. Many people using this medication||
7088|056|S|do not have serious side effects.||
7088|057|S|   Tell your doctor right away if you have any serious side||
7088|058|S|effects, including: burning/swelling/redness in or around the||
7088|059|S|eye.||
7088|060|S|   Use of this medication for prolonged or repeated periods may||
7088|061|S|result in a new fungal eye infection. Do not use this medication||
7088|062|S|for longer than prescribed. Contact your doctor if you notice new||
7088|063|S|or worsening symptoms.||
7088|064|S|   A very serious allergic reaction to this drug is rare.||
7088|065|S|However, get medical help right away if you notice any symptoms||
7088|066|S|of a serious allergic reaction, including: rash, itching/swelling||
7088|067|S|(especially of the face/tongue/throat), chest tightness, severe||
7088|068|S|dizziness, trouble breathing.||
7088|069|S|   This is not a complete list of possible side effects. If you||
7088|070|S|notice other effects not listed above, contact your doctor or||
7088|071|S|pharmacist.||
7088|072|S|   In the US -||
7088|073|S|   Call your doctor for medical advice about side effects. You||
7088|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7088|075|S|www.fda.gov/medwatch.||
7088|076|S|   In Canada - Call your doctor for medical advice about side||
7088|077|S|effects. You may report side effects to Health Canada at||
7088|078|S|1-866-234-2345.||
7088|079|B|||
7088|080|P|PRECAUTIONS:  Before using bacitracin, tell your doctor or||
7088|081|P|pharmacist if you are allergic to it; or to neomycin; or if you||
7088|082|P|have any other allergies. This product may contain inactive||
7088|083|P|ingredients, which can cause allergic reactions or other||
7088|084|P|problems. Talk to your pharmacist for more details.||
7088|085|P|   Before using this medication, tell your doctor or pharmacist||
7088|086|P|your medical history.||
7088|087|P|   After you apply this drug, your vision may become temporarily||
7088|088|P|blurred. Do not drive, use machinery, or do anything that needs||
7088|089|P|clear vision until you can do it safely.||
7088|090|P|   During pregnancy, this medication should be used only when||
7088|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
7088|092|P|   It is unknown if this drug passes into breast milk. Consult||
7088|093|P|your doctor before breastfeeding.||
7088|094|B|||
7088|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7088|096|I|medications work or increase your risk for serious side effects.||
7088|097|I|This document does not contain all possible drug interactions.||
7088|098|I|Keep a list of all the products you use (including||
7088|099|I|prescription/nonprescription drugs and herbal products) and share||
7088|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
7088|101|I|the dosage of any medicines without your doctor's approval.||
7088|102|B|||
7088|103|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7088|104|O|has overdosed and has serious symptoms such as passing out or||
7088|105|O|trouble breathing, call 911. Otherwise, call a poison control||
7088|106|O|center right away. US residents can call 1-800-222-1222. Canada||
7088|107|O|residents can call 1-844-764-7669.||
7088|108|B|||
7088|109|N|NOTES:  Do not share this medication with others.||
7088|110|N|   This medication has been prescribed for your current condition||
7088|111|N|only. Throw away the unused medication after treatment is||
7088|112|N|completed. Do not use it later for another infection unless your||
7088|113|N|doctor tells you to.||
7088|114|B|||
7088|115|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7088|116|D|If it is near the time of the next dose, skip the missed dose.||
7088|117|D|Use your next dose at the regular time. Do not double the dose to||
7088|118|D|catch up.||
7088|119|B|||
7088|120|R|STORAGE:  Store at room temperature away from heat. Keep all||
7088|121|R|medications away from children and pets.||
7088|122|R|   Do not flush medications down the toilet or pour them into a||
7088|123|R|drain unless instructed to do so. Properly discard this product||
7088|124|R|when it is expired or no longer needed. Consult your pharmacist||
7088|125|R|or local waste disposal company.||
7088|126|B|||
7088|127|A|Information last revised May 2024.||
7088|128|A|Copyright(c) 2025 First Databank, Inc.||
7088|129|B|||
7091|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7091|002|Z|does NOT have all possible information about this product. This||
7091|003|Z|information does not assure that this product is safe, effective,||
7091|004|Z|or appropriate for you. This information is not individual||
7091|005|Z|medical advice and does not substitute for the advice of your||
7091|006|Z|health care professional. Always ask your health care||
7091|007|Z|professional for complete information about this product and your||
7091|008|Z|specific health needs.||
7091|009|B|||
7091|010|T|MUPIROCIN CREAM - TOPICAL||
7091|011|F|(mue-PIR-oh-sin)||
7091|012|B|||
7091|013|C|COMMON BRAND NAME(S): Bactroban||
7091|014|B|||
7091|015|U|USES:  Mupirocin is used to treat infected cuts or wounds. It is||
7091|016|U|an antibiotic. It works by stopping the growth of certain||
7091|017|U|bacteria.||
7091|018|B|||
7091|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7091|020|H|from your pharmacist before you start using mupirocin and each||
7091|021|H|time you get a refill. If you have any questions, ask your doctor||
7091|022|H|or pharmacist.||
7091|023|H|   Use this medication only on the skin. Clean and dry the||
7091|024|H|affected area first. Then apply a small amount of cream to the||
7091|025|H|area as directed by your doctor, usually 3 times a day. You may||
7091|026|H|cover the treated area with a bandage.||
7091|027|H|   Use this medication regularly to get the most benefit from it.||
7091|028|H|Continue to use it for the full time prescribed, even if symptoms||
7091|029|H|disappear after a few days. Stopping the medication too early may||
7091|030|H|result in a return of the infection.||
7091|031|H|   Keep mupirocin away from your eyes, nose, or mouth unless||
7091|032|H|otherwise directed by your doctor. If you accidentally get it in||
7091|033|H|your eyes, nose, or mouth, rinse well with plenty of water.||
7091|034|H|   Tell your doctor if your condition does not get better in 3 to||
7091|035|H|5 days.||
7091|036|B|||
7091|037|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
7091|038|S|because your doctor has judged that the benefit to you is greater||
7091|039|S|than the risk of side effects. Many people using this medication||
7091|040|S|do not have serious side effects.||
7091|041|S|   Although uncommon, mild burning or stinging after using this||
7091|042|S|medication may occur. If you have severe burning, stinging, or||
7091|043|S|irritation, stop using this medication and tell your doctor right||
7091|044|S|away.||
7091|045|S|   This medication may rarely cause a severe intestinal condition||
7091|046|S|due to a bacteria called C. difficile. This condition may occur||
7091|047|S|during treatment or weeks to months after treatment has stopped.||
7091|048|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7091|049|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7091|050|S|stool.||
7091|051|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7091|052|S|products because they may make symptoms worse.||
7091|053|S|   Use of this medication for prolonged or repeated periods may||
7091|054|S|result in a new skin infection caused by fungus or yeast. Tell||
7091|055|S|your doctor right away if you notice signs of a new infection, or||
7091|056|S|if your current infection does not get better or if it gets||
7091|057|S|worse.||
7091|058|S|   A very serious allergic reaction to this drug is rare.||
7091|059|S|However, get medical help right away if you notice any symptoms||
7091|060|S|of a serious allergic reaction, including: rash, itching/swelling||
7091|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7091|062|S|breathing.||
7091|063|S|   This is not a complete list of possible side effects. If you||
7091|064|S|notice other effects not listed above, contact your doctor or||
7091|065|S|pharmacist.||
7091|066|S|   In the US -||
7091|067|S|   Call your doctor for medical advice about side effects. You||
7091|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7091|069|S|www.fda.gov/medwatch.||
7091|070|S|   In Canada - Call your doctor for medical advice about side||
7091|071|S|effects. You may report side effects to Health Canada at||
7091|072|S|1-866-234-2345.||
7091|073|B|||
7091|074|P|PRECAUTIONS:  Before using mupirocin, tell your doctor or||
7091|075|P|pharmacist if you are allergic to it; or if you have any other||
7091|076|P|allergies. This product may contain inactive ingredients, which||
7091|077|P|can cause allergic reactions or other problems. Talk to your||
7091|078|P|pharmacist for more details.||
7091|079|P|   Before using this medication, tell your doctor or pharmacist||
7091|080|P|your medical history.||
7091|081|P|   Before having surgery, tell your doctor or dentist about all||
7091|082|P|the products you use (including prescription drugs,||
7091|083|P|nonprescription drugs, and herbal products).||
7091|084|P|   During pregnancy, this medication should be used only when||
7091|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
7091|086|P|   It is unknown if this drug passes into breast milk. Consult||
7091|087|P|your doctor before breastfeeding.||
7091|088|B|||
7091|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7091|090|I|medications work or increase your risk for serious side effects.||
7091|091|I|This document does not contain all possible drug interactions.||
7091|092|I|Keep a list of all the products you use (including||
7091|093|I|prescription/nonprescription drugs and herbal products) and share||
7091|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
7091|095|I|the dosage of any medicines without your doctor's approval.||
7091|096|B|||
7091|097|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7091|098|O|has overdosed and has serious symptoms such as passing out or||
7091|099|O|trouble breathing, call 911. Otherwise, call a poison control||
7091|100|O|center right away. US residents can call 1-800-222-1222. Canada||
7091|101|O|residents can call 1-844-764-7669.||
7091|102|B|||
7091|103|N|NOTES:  Do not share this medication with others.||
7091|104|N|   This medication has been prescribed for your current condition||
7091|105|N|only. Do not use it later for another infection unless your||
7091|106|N|doctor tells you to.||
7091|107|B|||
7091|108|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7091|109|D|If it is near the time of the next dose, skip the missed dose.||
7091|110|D|Use your next dose at the regular time. Do not double the dose to||
7091|111|D|catch up.||
7091|112|B|||
7091|113|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
7091|114|R|medications away from children and pets.||
7091|115|R|   Do not flush medications down the toilet or pour them into a||
7091|116|R|drain unless instructed to do so. Properly discard this product||
7091|117|R|when it is expired or no longer needed. Consult your pharmacist||
7091|118|R|or local waste disposal company.||
7091|119|B|||
7091|120|A|Information last revised May 2024.||
7091|121|A|Copyright(c) 2025 First Databank, Inc.||
7091|122|B|||
7092|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7092|002|Z|does NOT have all possible information about this product. This||
7092|003|Z|information does not assure that this product is safe, effective,||
7092|004|Z|or appropriate for you. This information is not individual||
7092|005|Z|medical advice and does not substitute for the advice of your||
7092|006|Z|health care professional. Always ask your health care||
7092|007|Z|professional for complete information about this product and your||
7092|008|Z|specific health needs.||
7092|009|B|||
7092|010|T|PRAVASTATIN - ORAL||
7092|011|F|(PRAV-uh-stat-in)||
7092|012|B|||
7092|013|C|COMMON BRAND NAME(S): Pravachol||
7092|014|B|||
7092|015|U|USES:  Pravastatin is used along with a proper diet to help lower||
7092|016|U|"bad" cholesterol and fats (such as LDL, triglycerides) and raise||
7092|017|U|"good" cholesterol (HDL) in the blood. It belongs to a group of||
7092|018|U|drugs known as "statins." It works by reducing the amount of||
7092|019|U|cholesterol made by the liver. Lowering "bad" cholesterol and||
7092|020|U|triglycerides and raising "good" cholesterol decreases the risk||
7092|021|U|of heart disease and helps prevent strokes and heart attacks.||
7092|022|U|   In addition to eating a proper diet (such as a||
7092|023|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
7092|024|U|help this medication work better include exercising, losing||
7092|025|U|weight if overweight, and stopping smoking. Consult your doctor||
7092|026|U|for more details.||
7092|027|B|||
7092|028|H|HOW TO USE:  Take this medication by mouth with or without food||
7092|029|H|as directed by your doctor, usually once daily.||
7092|030|H|   The dosage is based on your medical condition, response to||
7092|031|H|treatment, age, and other medications you may be taking. Be sure||
7092|032|H|to tell your doctor and pharmacist about all the products you use||
7092|033|H|(including prescription drugs, nonprescription drugs, and herbal||
7092|034|H|products).||
7092|035|H|   If you also take certain other drugs to lower your cholesterol||
7092|036|H|(bile acid-binding resins such as cholestyramine or colestipol),||
7092|037|H|take pravastatin at least 1 hour before or at least 4 hours after||
7092|038|H|taking these medications. These products can react with||
7092|039|H|pravastatin, preventing its full absorption.||
7092|040|H|   Take this medication regularly in order to get the most||
7092|041|H|benefit from it. Remember to take it at the same time each day.||
7092|042|H|Keep taking this medication even if you feel well. Most people||
7092|043|H|with high cholesterol or triglycerides do not feel sick.||
7092|044|H|   It is very important to continue to follow your doctor's||
7092|045|H|advice about diet and exercise. It may take up to 4 weeks before||
7092|046|H|you get the full benefit of this drug.||
7092|047|B|||
7092|048|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
7092|049|S|because your doctor has judged that the benefit to you is greater||
7092|050|S|than the risk of side effects. Many people using this medication||
7092|051|S|do not have serious side effects.||
7092|052|S|   A very small number of people taking pravastatin may have mild||
7092|053|S|memory problems or confusion. If these rare effects occur, talk||
7092|054|S|to your doctor.||
7092|055|S|   Rarely, statins may cause or worsen diabetes. Talk to your||
7092|056|S|doctor about the benefits and risks.||
7092|057|S|   This drug may rarely cause muscle problems (which can rarely||
7092|058|S|lead to very serious conditions called rhabdomyolysis and||
7092|059|S|autoimmune myopathy). Tell your doctor right away if you develop||
7092|060|S|any of these symptoms during treatment and if these symptoms last||
7092|061|S|after your doctor stops this drug: muscle||
7092|062|S|pain/tenderness/weakness (especially with fever or unusual||
7092|063|S|tiredness), signs of kidney problems (such as change in the||
7092|064|S|amount of urine).||
7092|065|S|   This medication may rarely cause liver problems. Tell your||
7092|066|S|doctor right away if you develop symptoms of liver problems,||
7092|067|S|including: nausea/vomiting that doesn't stop, yellowing||
7092|068|S|eyes/skin, dark urine, stomach/abdominal pain.||
7092|069|S|   A very serious allergic reaction to this drug is rare.||
7092|070|S|However, get medical help right away if you notice any symptoms||
7092|071|S|of a serious allergic reaction, including: rash, itching/swelling||
7092|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7092|073|S|breathing.||
7092|074|S|   This is not a complete list of possible side effects. If you||
7092|075|S|notice other effects not listed above, contact your doctor or||
7092|076|S|pharmacist.||
7092|077|S|   In the US -||
7092|078|S|   Call your doctor for medical advice about side effects. You||
7092|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7092|080|S|www.fda.gov/medwatch.||
7092|081|S|   In Canada - Call your doctor for medical advice about side||
7092|082|S|effects. You may report side effects to Health Canada at||
7092|083|S|1-866-234-2345.||
7092|084|B|||
7092|085|P|PRECAUTIONS:  Before taking pravastatin, tell your doctor or||
7092|086|P|pharmacist if you are allergic to it; or if you have any other||
7092|087|P|allergies. This product may contain inactive ingredients, which||
7092|088|P|can cause allergic reactions or other problems. Talk to your||
7092|089|P|pharmacist for more details.||
7092|090|P|   Before using this medication, tell your doctor or pharmacist||
7092|091|P|your medical history, especially of: liver disease, kidney||
7092|092|P|disease, alcohol use.||
7092|093|P|   Before having surgery, tell your doctor or dentist about all||
7092|094|P|the products you use (including prescription drugs,||
7092|095|P|nonprescription drugs, and herbal products).||
7092|096|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
7092|097|P|your risk for liver problems, especially when combined with||
7092|098|P|pravastatin. Ask your doctor or pharmacist for more information.||
7092|099|P|   Older adults may be more sensitive to the side effects of this||
7092|100|P|drug, especially muscle problems.||
7092|101|P|   During pregnancy, this medication should be used only when||
7092|102|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
7092|103|P|benefits with your doctor.||
7092|104|P|   This medication passes into breast milk and may have||
7092|105|P|undesirable effects on a nursing infant. Breastfeeding is not||
7092|106|P|recommended while using this medication. Consult your doctor||
7092|107|P|before breastfeeding.||
7092|108|B|||
7092|109|I|DRUG INTERACTIONS:  See also How To Use section.||
7092|110|I|   Drug interactions may change how your medications work or||
7092|111|I|increase your risk for serious side effects. This document does||
7092|112|I|not contain all possible drug interactions. Keep a list of all||
7092|113|I|the products you use (including prescription/nonprescription||
7092|114|I|drugs and herbal products) and share it with your doctor and||
7092|115|I|pharmacist. Do not start, stop, or change the dosage of any||
7092|116|I|medicines without your doctor's approval.||
7092|117|I|   Some products that may interact with this drug include:||
7092|118|I|colchicine, daptomycin, gemfibrozil.||
7092|119|I|   Do not take any red yeast rice products while you are taking||
7092|120|I|pravastatin because some red yeast rice products may also contain||
7092|121|I|a statin called lovastatin. Taking pravastatin and red yeast rice||
7092|122|I|products together can increase your risk of serious muscle and||
7092|123|I|liver problems.||
7092|124|B|||
7092|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7092|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7092|127|O|poison control center right away. US residents can call||
7092|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7092|129|B|||
7092|130|N|NOTES:  Do not share this medication with others.||
7092|131|N|   Lab and/or medical tests (such as blood||
7092|132|N|cholesterol/triglyceride levels, liver function) should be done||
7092|133|N|while you are taking this medication. Keep all medical and lab||
7092|134|N|appointments. Consult your doctor for more details.||
7092|135|B|||
7092|136|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7092|137|D|remember. If it is near the time of the next dose, skip the||
7092|138|D|missed dose. Take your next dose at the regular time. Do not||
7092|139|D|double the dose to catch up.||
7092|140|B|||
7092|141|R|STORAGE:  Store at room temperature away from light and moisture.||
7092|142|R|Do not store in the bathroom. Keep all medications away from||
7092|143|R|children and pets.||
7092|144|R|   Do not flush medications down the toilet or pour them into a||
7092|145|R|drain unless instructed to do so. Properly discard this product||
7092|146|R|when it is expired or no longer needed. Consult your pharmacist||
7092|147|R|or local waste disposal company.||
7092|148|B|||
7092|149|A|Information last revised May 2024.||
7092|150|A|Copyright(c) 2025 First Databank, Inc.||
7092|151|B|||
7094|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7094|002|Z|does NOT have all possible information about this product. This||
7094|003|Z|information does not assure that this product is safe, effective,||
7094|004|Z|or appropriate for you. This information is not individual||
7094|005|Z|medical advice and does not substitute for the advice of your||
7094|006|Z|health care professional. Always ask your health care||
7094|007|Z|professional for complete information about this product and your||
7094|008|Z|specific health needs.||
7094|009|B|||
7094|010|T|MODAFINIL - ORAL||
7094|011|F|(moe-DAF-i-nil)||
7094|012|B|||
7094|013|C|COMMON BRAND NAME(S): Provigil||
7094|014|B|||
7094|015|U|USES:  Modafinil reduces extreme sleepiness due to narcolepsy and||
7094|016|U|other sleep disorders, such as periods of stopped breathing||
7094|017|U|during sleep (obstructive sleep apnea). It is also used to help||
7094|018|U|you stay awake during work hours if you have a work schedule that||
7094|019|U|keeps you from having a normal sleep routine (shift work sleep||
7094|020|U|disorder).||
7094|021|U|   This medication does not cure these sleep disorders and may||
7094|022|U|not get rid of all your sleepiness. Modafinil does not take the||
7094|023|U|place of getting enough sleep. It should not be used to treat||
7094|024|U|tiredness or hold off sleep in people who do not have a sleep||
7094|025|U|disorder.||
7094|026|U|   It is not known how modafinil works to keep you awake. It is||
7094|027|U|thought to work by affecting certain substances in the brain that||
7094|028|U|control the sleep/wake cycle.||
7094|029|B|||
7094|030|H|HOW TO USE:  Read the Medication Guide provided by your||
7094|031|H|pharmacist before you start using modafinil and each time you get||
7094|032|H|a refill. If you have any questions, ask your doctor or||
7094|033|H|pharmacist.||
7094|034|H|   For narcolepsy, take this medication by mouth with or without||
7094|035|H|food as directed by your doctor, usually once daily in the||
7094|036|H|morning. Or, if your doctor directs you to, the total daily dose||
7094|037|H|of modafinil may be divided into a morning dose and a noon dose.||
7094|038|H|   For obstructive sleep apnea, take this medication by mouth||
7094|039|H|with or without food as directed by your doctor, usually once||
7094|040|H|daily in the morning. Continue your other treatment (such as the||
7094|041|H|CPAP machine, mouth device) unless your doctor tells you to stop.||
7094|042|H|   If you are using modafinil for shift work sleep disorder, take||
7094|043|H|it by mouth with or without food as directed by your doctor,||
7094|044|H|usually once a day 1 hour before you start your work shift.||
7094|045|H|   The dosage is based on your medical condition and response to||
7094|046|H|treatment. Take this medication regularly to get the most benefit||
7094|047|H|from it.||
7094|048|H|   Caffeine can increase the side effects of this medication.||
7094|049|H|Avoid drinking large amounts of beverages containing caffeine||
7094|050|H|(coffee, tea, colas), eating large amounts of chocolate, or||
7094|051|H|taking nonprescription products that contain caffeine.||
7094|052|H|   If you suddenly stop using this medication, you may have||
7094|053|H|withdrawal symptoms (such as shaking, sweating, chills, nausea,||
7094|054|H|vomiting, confusion). To help prevent withdrawal, your doctor may||
7094|055|H|lower your dose slowly. Withdrawal is more likely if you have||
7094|056|H|used modafinil for a long time or in high doses. Tell your doctor||
7094|057|H|or pharmacist right away if you have withdrawal.||
7094|058|H|   When this medication is used for a long time, it may not work||
7094|059|H|as well. Talk with your doctor if this medication stops working||
7094|060|H|well.||
7094|061|H|   Though it helps many people, this medication may sometimes||
7094|062|H|cause addiction. This risk may be higher if you have a substance||
7094|063|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
7094|064|H|Take this medication exactly as prescribed to lower the risk of||
7094|065|H|addiction. Ask your doctor or pharmacist for more details.||
7094|066|H|   Tell your doctor if your condition does not get better or if||
7094|067|H|it gets worse.||
7094|068|B|||
7094|069|S|SIDE EFFECTS:  Headache, nausea, nervousness, dizziness, or||
7094|070|S|difficulty sleeping may occur. If any of these effects last or||
7094|071|S|get worse, tell your doctor or pharmacist promptly.||
7094|072|S|   Remember that this medication has been prescribed because your||
7094|073|S|doctor has judged that the benefit to you is greater than the||
7094|074|S|risk of side effects. Many people using this medication do not||
7094|075|S|have serious side effects.||
7094|076|S|   Tell your doctor right away if you have any serious side||
7094|077|S|effects, including: fast/pounding/irregular heartbeat,||
7094|078|S|mental/mood changes (such as agitation, confusion, depression,||
7094|079|S|hallucinations, rare thoughts of suicide).||
7094|080|S|   Get medical help right away if you have any very serious side||
7094|081|S|effects, including: chest pain.||
7094|082|S|   A very serious allergic reaction to this drug is rare.||
7094|083|S|However, get medical help right away if you notice any symptoms||
7094|084|S|of a serious allergic reaction, including: fever, swollen lymph||
7094|085|S|nodes, rash, itching/swelling (especially of the||
7094|086|S|face/tongue/throat), severe dizziness, trouble breathing.||
7094|087|S|   This is not a complete list of possible side effects. If you||
7094|088|S|notice other effects not listed above, contact your doctor or||
7094|089|S|pharmacist.||
7094|090|S|   In the US -||
7094|091|S|   Call your doctor for medical advice about side effects. You||
7094|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7094|093|S|www.fda.gov/medwatch.||
7094|094|S|   In Canada - Call your doctor for medical advice about side||
7094|095|S|effects. You may report side effects to Health Canada at||
7094|096|S|1-866-234-2345.||
7094|097|B|||
7094|098|P|PRECAUTIONS:  Before taking modafinil, tell your doctor or||
7094|099|P|pharmacist if you are allergic to it; or to armodafinil; or if||
7094|100|P|you have any other allergies. This product may contain inactive||
7094|101|P|ingredients, which can cause allergic reactions or other||
7094|102|P|problems. Talk to your pharmacist for more details.||
7094|103|P|   Before using this medication, tell your doctor or pharmacist||
7094|104|P|your medical history, especially of: heart problems (such as||
7094|105|P|enlarged heart, mitral valve problem, chest pain, heart attack,||
7094|106|P|irregular heartbeat), heart problems after taking stimulant drugs||
7094|107|P|such as amphetamines (including chest pain, irregular heartbeat),||
7094|108|P|high blood pressure, liver problems, mental/mood disorders (such||
7094|109|P|as depression, mania, psychosis), personal or family history of a||
7094|110|P|substance use disorder (such as overuse of or addiction to||
7094|111|P|drugs/alcohol).||
7094|112|P|   Sleep disorders may reduce your ability to react quickly.||
7094|113|P|Though modafinil helps keep you awake, you still may not be able||
7094|114|P|to safely do things that require quick reactions (such as||
7094|115|P|driving). This drug may also make you dizzy. Alcohol or marijuana||
7094|116|P|(cannabis) can make you more dizzy. Do not drive, use machinery,||
7094|117|P|or do anything that needs alertness until you can do it safely.||
7094|118|P|Avoid alcoholic beverages. Talk to your doctor if you are using||
7094|119|P|marijuana (cannabis).||
7094|120|P|   Before having surgery, tell your doctor or dentist about all||
7094|121|P|the products you use (including prescription drugs,||
7094|122|P|nonprescription drugs, and herbal products).||
7094|123|P|   Tell your doctor if you are pregnant or plan to become||
7094|124|P|pregnant. You should not become pregnant while using modafinil.||
7094|125|P|Modafinil may harm an unborn baby. Ask about reliable forms of||
7094|126|P|non-hormonal birth control while using this medication and for 2||
7094|127|P|months after the last dose. If you become pregnant, talk to your||
7094|128|P|doctor right away about the risks and benefits of this||
7094|129|P|medication.||
7094|130|P|   It is unknown if this drug passes into breast milk. Consult||
7094|131|P|your doctor before breastfeeding.||
7094|132|B|||
7094|133|I|DRUG INTERACTIONS:  See also How to Use section.||
7094|134|I|   Drug interactions may change how your medications work or||
7094|135|I|increase your risk for serious side effects. This document does||
7094|136|I|not contain all possible drug interactions. Keep a list of all||
7094|137|I|the products you use (including prescription/nonprescription||
7094|138|I|drugs and herbal products) and share it with your doctor and||
7094|139|I|pharmacist. Do not start, stop, or change the dosage of any||
7094|140|I|medicines without your doctor's approval.||
7094|141|I|   Some products that may interact with this drug include: street||
7094|142|I|drugs (such as methamphetamine, MDMA/"ecstasy").||
7094|143|I|   This medication may decrease the effectiveness of hormonal||
7094|144|I|birth control such as pills, patch, or ring. This could cause||
7094|145|I|pregnancy. Discuss with your doctor or pharmacist if you should||
7094|146|I|use reliable backup birth control methods while using this||
7094|147|I|medication and for 1 month after the last dose. Also tell your||
7094|148|I|doctor if you have any new spotting or breakthrough bleeding,||
7094|149|I|because these may be signs that your birth control is not working||
7094|150|I|well.||
7094|151|I|   Modafinil can speed up the removal of other medications from||
7094|152|I|your body, which may affect how they work. Examples of affected||
7094|153|I|drugs include axitinib, bosutinib, daridorexant, elacestrant,||
7094|154|I|mavacamten, quizartinib, revumenib, among others.||
7094|155|I|   Some products have ingredients that could raise your heart||
7094|156|I|rate or blood pressure. Tell your pharmacist what products you||
7094|157|I|are using, and ask how to use them safely (especially||
7094|158|I|cough-and-cold products or diet aids).||
7094|159|I|   Modafinil is very similar to armodafinil. Do not take||
7094|160|I|medications containing armodafinil while using modafinil.||
7094|161|B|||
7094|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7094|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7094|164|O|poison control center right away. US residents can call||
7094|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7094|166|O|Symptoms of overdose include: fast/irregular heartbeat, severe||
7094|167|O|restlessness, hallucinations.||
7094|168|B|||
7094|169|N|NOTES:  Do not share this medication with others. Sharing it is||
7094|170|N|against the law.||
7094|171|N|   Lab and/or medical tests (such as blood pressure, heart rate)||
7094|172|N|may be done while you are taking this medication. Keep all||
7094|173|N|medical and lab appointments. Consult your doctor for more||
7094|174|N|details.||
7094|175|N|   Follow good sleep habits (such as sleeping in a dark/quiet||
7094|176|N|room, avoiding caffeine close to bedtime) which can help improve||
7094|177|N|your sleep if you have shift work sleep disorder.||
7094|178|B|||
7094|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7094|180|D|remember. If it is near the time of the next dose, skip the||
7094|181|D|missed dose. Take your next dose at the regular time. Do not||
7094|182|D|double the dose to catch up. Do not take missed doses close to||
7094|183|D|bedtime because doing so may make it harder to go to sleep.||
7094|184|B|||
7094|185|R|STORAGE:  Store at room temperature away from light and moisture.||
7094|186|R|Do not store in the bathroom. Keep all medications away from||
7094|187|R|children and pets.||
7094|188|R|   Do not flush medications down the toilet or pour them into a||
7094|189|R|drain unless instructed to do so. Properly discard this product||
7094|190|R|when it is expired or no longer needed. Consult your pharmacist||
7094|191|R|or local waste disposal company.||
7094|192|B|||
7094|193|A|Information last revised July 2025.||
7094|194|A|Copyright(c) 2025 First Databank, Inc.||
7094|195|B|||
7095|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7095|002|Z|does NOT have all possible information about this product. This||
7095|003|Z|information does not assure that this product is safe, effective,||
7095|004|Z|or appropriate for you. This information is not individual||
7095|005|Z|medical advice and does not substitute for the advice of your||
7095|006|Z|health care professional. Always ask your health care||
7095|007|Z|professional for complete information about this product and your||
7095|008|Z|specific health needs.||
7095|009|B|||
7095|010|T|FLUVOXAMINE - ORAL||
7095|011|F|(floo-VOX-a-meen)||
7095|012|B|||
7095|013|C|COMMON BRAND NAME(S): Luvox||
7095|014|B|||
7095|015|W|WARNING:  Antidepressant medications are used to treat a variety||
7095|016|W|of conditions, including depression and other mental/mood||
7095|017|W|disorders. These medications can help prevent suicidal||
7095|018|W|thoughts/attempts and provide other important benefits. However,||
7095|019|W|studies have shown that a small number of people (especially||
7095|020|W|people younger than 25) who take antidepressants for any||
7095|021|W|condition may experience worsening depression, other mental/mood||
7095|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
7095|023|W|talk with the doctor about the risks and benefits of||
7095|024|W|antidepressant medication (especially for people younger than||
7095|025|W|25), even if treatment is not for a mental/mood condition.||
7095|026|W|   Tell the doctor right away if you notice worsening||
7095|027|W|depression/other psychiatric conditions, unusual behavior changes||
7095|028|W|(including possible suicidal thoughts/attempts), or other||
7095|029|W|mental/mood changes (including new/worsening anxiety, panic||
7095|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
7095|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
7095|032|W|especially watchful for these symptoms when a new antidepressant||
7095|033|W|is started or when the dose is changed.||
7095|034|B|||
7095|035|U|USES:  This medication is used to treat obsessive-compulsive||
7095|036|U|disorder (OCD). Fluvoxamine belongs to a class of drugs known as||
7095|037|U|selective serotonin reuptake inhibitors (SSRIs). It works by||
7095|038|U|helping to restore the balance of a certain natural substance||
7095|039|U|(serotonin) in the brain.||
7095|040|B|||
7095|041|V|OTHER USES:  This section contains uses of this drug that are not||
7095|042|V|listed in the approved professional labeling for the drug but||
7095|043|V|that may be prescribed by your health care professional. Use this||
7095|044|V|drug for a condition that is listed in this section only if it||
7095|045|V|has been so prescribed by your health care professional.||
7095|046|V|   This drug may also be used for anxiety disorders, depression,||
7095|047|V|post-traumatic stress disorder, or binge eating disorder (BED).||
7095|048|B|||
7095|049|H|HOW TO USE:  Read the Medication Guide and, if available, the||
7095|050|H|Patient Information Leaflet provided by your pharmacist before||
7095|051|H|you start taking fluvoxamine and each time you get a refill. If||
7095|052|H|you have any questions, ask your doctor or pharmacist.||
7095|053|H|   Take this medication by mouth with or without food as directed||
7095|054|H|by your doctor, usually once daily at bedtime, or twice daily||
7095|055|H|(once in the morning and once at bedtime). If you are taking this||
7095|056|H|medication twice daily and the doses are not equal, then the||
7095|057|H|larger of the 2 doses should be taken at bedtime.||
7095|058|H|   The dosage is based on your medical condition, response to||
7095|059|H|treatment, age, and other medications you may be taking.||
7095|060|H|Children's dosage may also be based on age and gender. Be sure to||
7095|061|H|tell your doctor and pharmacist about all the products you use||
7095|062|H|(including prescription drugs, nonprescription drugs, and herbal||
7095|063|H|products). To reduce your risk of side effects, your doctor may||
7095|064|H|direct you to start this medication at a low dose and gradually||
7095|065|H|increase your dose. Follow your doctor's instructions carefully.||
7095|066|H|   Do not increase your dose or use this drug more often or for||
7095|067|H|longer than prescribed. Your condition will not improve any||
7095|068|H|faster, and your risk of side effects will increase. Take this||
7095|069|H|medication regularly to get the most benefit from it. To help you||
7095|070|H|remember, take it at the same time(s) each day.||
7095|071|H|   Keep taking this medication even if you feel well. Do not stop||
7095|072|H|taking this medication without consulting your doctor. Some||
7095|073|H|conditions may become worse when this drug is suddenly stopped.||
7095|074|H|Also, you may experience symptoms such as mood swings, headache,||
7095|075|H|tiredness, sleep changes, and brief feelings similar to electric||
7095|076|H|shock. To prevent these symptoms while you are stopping treatment||
7095|077|H|with this drug, your doctor may reduce your dose gradually.||
7095|078|H|Consult your doctor or pharmacist for more details. Report any||
7095|079|H|new or worsening symptoms right away.||
7095|080|H|   This medication can increase the effects of caffeine. Avoid||
7095|081|H|drinking large amounts of beverages containing caffeine (coffee,||
7095|082|H|tea, colas), eating large amounts of chocolate, or taking||
7095|083|H|nonprescription products that contain caffeine.||
7095|084|H|   It may take up to several weeks before you get the full||
7095|085|H|benefit of this drug.||
7095|086|H|   Tell your doctor if your condition does not get better or if||
7095|087|H|it gets worse.||
7095|088|B|||
7095|089|S|SIDE EFFECTS:  See also Warning section.||
7095|090|S|   Nausea, vomiting, drowsiness, dizziness, loss of appetite,||
7095|091|S|trouble sleeping, weakness, and sweating may occur. If any of||
7095|092|S|these effects last or get worse, tell your doctor or pharmacist||
7095|093|S|promptly.||
7095|094|S|   Remember that this medication has been prescribed because your||
7095|095|S|doctor has judged that the benefit to you is greater than the||
7095|096|S|risk of side effects. Many people using this medication do not||
7095|097|S|have serious side effects.||
7095|098|S|   Tell your doctor right away if you have any serious side||
7095|099|S|effects, including: easy bleeding/bruising, shaking (tremor),||
7095|100|S|decreased interest in sex, changes in sexual ability.||
7095|101|S|   Get medical help right away if you have any very serious side||
7095|102|S|effects, including: fainting, irregular heartbeat, black stools,||
7095|103|S|vomit that looks like coffee grounds, seizures, eye||
7095|104|S|pain/swelling/redness, widened pupils, vision changes (such as||
7095|105|S|seeing rainbows around lights at night, blurred vision).||
7095|106|S|   This medication may increase serotonin and rarely cause a very||
7095|107|S|serious condition called serotonin syndrome/toxicity. The risk||
7095|108|S|increases if you are also taking other drugs that increase||
7095|109|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
7095|110|S|take (see Drug Interactions section). Get medical help right away||
7095|111|S|if you develop some of the following symptoms: fast heartbeat,||
7095|112|S|hallucinations, loss of coordination, severe dizziness, severe||
7095|113|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
7095|114|S|unusual restlessness.||
7095|115|S|   Rarely, males may have a painful or prolonged erection lasting||
7095|116|S|4 or more hours. If this occurs, stop using this drug and get||
7095|117|S|medical help right away, or permanent problems could occur.||
7095|118|S|   A very serious allergic reaction to this drug is rare.||
7095|119|S|However, get medical help right away if you notice any symptoms||
7095|120|S|of a serious allergic reaction, including: rash, itching/swelling||
7095|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7095|122|S|breathing.||
7095|123|S|   This is not a complete list of possible side effects. If you||
7095|124|S|notice other effects not listed above, contact your doctor or||
7095|125|S|pharmacist.||
7095|126|S|   In the US -||
7095|127|S|   Call your doctor for medical advice about side effects. You||
7095|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7095|129|S|www.fda.gov/medwatch.||
7095|130|S|   In Canada - Call your doctor for medical advice about side||
7095|131|S|effects. You may report side effects to Health Canada at||
7095|132|S|1-866-234-2345.||
7095|133|B|||
7095|134|P|PRECAUTIONS:  Before taking fluvoxamine, tell your doctor or||
7095|135|P|pharmacist if you are allergic to it; or if you have any other||
7095|136|P|allergies. This product may contain inactive ingredients, which||
7095|137|P|can cause allergic reactions or other problems. Talk to your||
7095|138|P|pharmacist for more details.||
7095|139|P|   Before using this medication, tell your doctor or pharmacist||
7095|140|P|your medical history, especially of: personal or family history||
7095|141|P|of bipolar/manic-depressive disorder, personal or family history||
7095|142|P|of suicide attempts, liver problems, seizures, low sodium in the||
7095|143|P|blood, bleeding problems, personal or family history of glaucoma||
7095|144|P|(angle-closure type).||
7095|145|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7095|146|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7095|147|P|machinery, or do anything that needs alertness until you can do||
7095|148|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
7095|149|P|are using marijuana (cannabis).||
7095|150|P|   Fluvoxamine may cause a condition that affects the heart||
7095|151|P|rhythm (QT prolongation). QT prolongation can rarely cause||
7095|152|P|serious (rarely fatal) fast/irregular heartbeat and other||
7095|153|P|symptoms (such as severe dizziness, fainting) that need medical||
7095|154|P|attention right away.||
7095|155|P|   The risk of QT prolongation may be increased if you have||
7095|156|P|certain medical conditions or are taking other drugs that may||
7095|157|P|cause QT prolongation. Before using fluvoxamine, tell your doctor||
7095|158|P|or pharmacist of all the drugs you take and if you have any of||
7095|159|P|the following conditions: certain heart problems (heart failure,||
7095|160|P|slow heartbeat, QT prolongation in the EKG), family history of||
7095|161|P|certain heart problems (QT prolongation in the EKG, sudden||
7095|162|P|cardiac death).||
7095|163|P|   Low levels of potassium or magnesium in the blood may also||
7095|164|P|increase your risk of QT prolongation. This risk may increase if||
7095|165|P|you use certain drugs (such as diuretics "water pills") or if you||
7095|166|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7095|167|P|Talk to your doctor about using fluvoxamine safely.||
7095|168|P|   Before having surgery, tell your doctor or dentist about all||
7095|169|P|the products you use (including prescription drugs,||
7095|170|P|nonprescription drugs, and herbal products).||
7095|171|P|   Older adults may be more sensitive to the side effects of this||
7095|172|P|drug, especially bleeding, or loss of coordination, QT||
7095|173|P|prolongation. Older adults may also be more likely to develop a||
7095|174|P|type of salt imbalance (hyponatremia), especially if they are||
7095|175|P|taking "water pills" (diuretics). Loss of coordination can||
7095|176|P|increase the risk of falling.||
7095|177|P|   Children may be more sensitive to the side effects of this||
7095|178|P|drug, especially loss of appetite and weight loss. Monitor weight||
7095|179|P|and height in children who are taking this drug.||
7095|180|P|   During pregnancy, this medication should be used only when||
7095|181|P|clearly needed. It may harm an unborn baby. Also, babies born to||
7095|182|P|mothers who have used this drug during the last 3 months of||
7095|183|P|pregnancy may rarely develop withdrawal symptoms such as||
7095|184|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
7095|185|P|constant crying. If you notice any of these symptoms in your||
7095|186|P|newborn, tell the doctor promptly.||
7095|187|P|   Since untreated mental/mood problems (such as depression,||
7095|188|P|obsessive compulsive disorder, post-traumatic stress disorder)||
7095|189|P|can be a serious condition, do not stop taking this medication||
7095|190|P|unless directed by your doctor. If you are planning pregnancy,||
7095|191|P|become pregnant, or think you may be pregnant, immediately||
7095|192|P|discuss with your doctor the benefits and risks of using this||
7095|193|P|medication during pregnancy.||
7095|194|P|   This drug passes into breast milk and may have undesirable||
7095|195|P|effects on a nursing infant. Consult your doctor before||
7095|196|P|breastfeeding.||
7095|197|B|||
7095|198|I|DRUG INTERACTIONS:  See also How to Use section.||
7095|199|I|   Drug interactions may change how your medications work or||
7095|200|I|increase your risk for serious side effects. This document does||
7095|201|I|not contain all possible drug interactions. Keep a list of all||
7095|202|I|the products you use (including prescription/nonprescription||
7095|203|I|drugs and herbal products) and share it with your doctor and||
7095|204|I|pharmacist. Do not start, stop, or change the dosage of any||
7095|205|I|medicines without your doctor's approval.||
7095|206|I|   Some products that may interact with this drug are: other||
7095|207|I|drugs that can cause bleeding/bruising (including antiplatelet||
7095|208|I|drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen,||
7095|209|I|"blood thinners" such as dabigatran/warfarin).||
7095|210|I|   Aspirin can increase the risk of bleeding when used with this||
7095|211|I|medication. However, if your doctor has told you to take low-dose||
7095|212|I|aspirin to prevent heart attack or stroke (usually 81-162||
7095|213|I|milligrams a day), you should keep taking the aspirin unless your||
7095|214|I|doctor tells you not to. Ask your doctor or pharmacist for more||
7095|215|I|details.||
7095|216|I|   Many drugs besides fluvoxamine may affect the heart rhythm (QT||
7095|217|I|prolongation), including pimozide, thioridazine, among others.||
7095|218|I|   This medication can slow down the removal of other medications||
7095|219|I|from your body, which may affect how they work. Examples of||
7095|220|I|affected drugs include alosetron, clozapine, methadone,||
7095|221|I|melatonin, ramelteon, tacrine, tizanidine, vorasidenib, certain||
7095|222|I|benzodiazepines (such as alprazolam, diazepam, triazolam),||
7095|223|I|tricyclic antidepressants (such as imipramine), among others.||
7095|224|I|   Taking MAO inhibitors with this medication may cause a serious||
7095|225|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
7095|226|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
7095|227|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
7095|228|I|selegiline, tranylcypromine) during treatment with this||
7095|229|I|medication. Most MAO inhibitors should also not be taken for two||
7095|230|I|weeks before and after treatment with this medication. Ask your||
7095|231|I|doctor when to start or stop taking this medication.||
7095|232|I|   The risk of serotonin syndrome/toxicity increases if you are||
7095|233|I|also taking other drugs that increase serotonin. Examples include||
7095|234|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
7095|235|I|antidepressants (including other SSRIs such as||
7095|236|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
7095|237|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
7095|238|I|may be more likely when you start or increase the dose of these||
7095|239|I|drugs.||
7095|240|I|   Tell your doctor or pharmacist if you are taking other||
7095|241|I|products that cause drowsiness including alcohol, marijuana||
7095|242|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
7095|243|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
7095|244|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
7095|245|I|codeine).||
7095|246|I|   Check the labels on all your medicines (such as allergy or||
7095|247|I|cough-and-cold products) because they may contain ingredients||
7095|248|I|that cause drowsiness. Ask your pharmacist about using those||
7095|249|I|products safely.||
7095|250|I|   Cigarette smoking decreases blood levels of this medication.||
7095|251|I|Tell your doctor if you smoke or if you have recently stopped||
7095|252|I|smoking.||
7095|253|I|   This medication may interfere with certain medical/lab tests||
7095|254|I|(such as brain scan for Parkinson's disease), possibly causing||
7095|255|I|false test results. Make sure lab personnel and all your doctors||
7095|256|I|know you use this drug.||
7095|257|B|||
7095|258|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7095|259|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7095|260|O|poison control center right away. US residents can call||
7095|261|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7095|262|O|Symptoms of overdose may include: fast/slow/irregular heartbeat,||
7095|263|O|trouble breathing, seizures.||
7095|264|B|||
7095|265|N|NOTES:  Do not share this medication with others.||
7095|266|N|   Keep all medical and lab appointments.||
7095|267|B|||
7095|268|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7095|269|D|remember. If it is near the time of the next dose, skip the||
7095|270|D|missed dose. Take your next dose at the regular time. Do not||
7095|271|D|double the dose to catch up.||
7095|272|B|||
7095|273|R|STORAGE:  Store at room temperature away from light and moisture.||
7095|274|R|Do not store in the bathroom. Keep all medications away from||
7095|275|R|children and pets.||
7095|276|R|   Do not flush medications down the toilet or pour them into a||
7095|277|R|drain unless instructed to do so. Properly discard this product||
7095|278|R|when it is expired or no longer needed. Consult your pharmacist||
7095|279|R|or local waste disposal company.||
7095|280|B|||
7095|281|A|Information last revised July 2025.||
7095|282|A|Copyright(c) 2025 First Databank, Inc.||
7095|283|B|||
7106|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7106|002|Z|does NOT have all possible information about this product. This||
7106|003|Z|information does not assure that this product is safe, effective,||
7106|004|Z|or appropriate for you. This information is not individual||
7106|005|Z|medical advice and does not substitute for the advice of your||
7106|006|Z|health care professional. Always ask your health care||
7106|007|Z|professional for complete information about this product and your||
7106|008|Z|specific health needs.||
7106|009|B|||
7106|010|T|VITAMIN K - INJECTION||
7106|011|B|||
7106|012|C|COMMON BRAND NAME(S): Aqua-Mephyton, Vitamin K||
7106|013|B|||
7106|014|W|WARNING:  The injectable form of vitamin K can rarely cause||
7106|015|W|severe (sometimes fatal) allergic reactions when given by||
7106|016|W|injection into a muscle or vein. Vitamin K should be injected||
7106|017|W|into a muscle or vein only when it cannot be given by injection||
7106|018|W|under the skin or taken by mouth, or when your doctor has judged||
7106|019|W|that the benefit is greater than the risk. Get medical help right||
7106|020|W|away if you experience symptoms of an allergic reaction such as||
7106|021|W|rash, itching, swelling, dizziness, or trouble breathing.||
7106|022|B|||
7106|023|U|USES:  Vitamin K is used to treat and prevent low levels of||
7106|024|U|certain substances (blood clotting factors) that your body||
7106|025|U|naturally produces. These substances help your blood to thicken||
7106|026|U|and stop bleeding normally (such as after an accidental cut or||
7106|027|U|injury). Low levels of blood clotting factors increase the risk||
7106|028|U|for unusual bleeding. Low levels may be caused by certain||
7106|029|U|medications (such as warfarin) or medical conditions (such as||
7106|030|U|obstructive jaundice). Vitamin K helps to treat and prevent||
7106|031|U|unusual bleeding by increasing the body's production of blood||
7106|032|U|clotting factors.||
7106|033|B|||
7106|034|H|HOW TO USE:  This medication is given by injection under the skin||
7106|035|H|or into a muscle or vein as directed by your doctor. If this||
7106|036|H|medication is given into a vein, it should be injected very||
7106|037|H|slowly (no more than 1 milligram per minute) to reduce the risk||
7106|038|H|of serious side effects. (See also Warning section.)||
7106|039|H|   The dosage is based on your medical condition and response to||
7106|040|H|treatment.||
7106|041|H|   If you are giving this medication to yourself at home, learn||
7106|042|H|all preparation and usage instructions from your health care||
7106|043|H|professional. Before using, check this product for particles or||
7106|044|H|discoloration. If either is present, do not use the liquid. Learn||
7106|045|H|how to store and discard medical supplies safely.||
7106|046|H|   If you are using a certain "blood thinner" drug (warfarin),||
7106|047|H|vitamin K can decrease the effects of warfarin for up to 2 weeks.||
7106|048|H|Be sure to take your vitamin K and warfarin exactly as directed||
7106|049|H|by your doctor or pharmacist.||
7106|050|H|   If you develop easy bruising or bleeding, get medical help||
7106|051|H|right away. You may need another dose of vitamin K.||
7106|052|B|||
7106|053|S|SIDE EFFECTS:  Pain, swelling, or soreness at the injection site||
7106|054|S|may occur. Temporary flushing, taste changes, dizziness, rapid||
7106|055|S|heartbeat, sweating, shortness of breath, or bluish||
7106|056|S|lips/skin/nails may also rarely occur. If any of these effects||
7106|057|S|last or get worse, tell your doctor or pharmacist promptly.||
7106|058|S|   Remember that this medication has been prescribed because your||
7106|059|S|doctor has judged that the benefit to you is greater than the||
7106|060|S|risk of side effects. Many people using this medication do not||
7106|061|S|have serious side effects.||
7106|062|S|   A very serious allergic reaction to this drug is rare.||
7106|063|S|However, get medical help right away if you notice any symptoms||
7106|064|S|of a serious allergic reaction, including: rash, itching/swelling||
7106|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7106|066|S|breathing.||
7106|067|S|   This is not a complete list of possible side effects. If you||
7106|068|S|notice other effects not listed above, contact your doctor or||
7106|069|S|pharmacist.||
7106|070|S|   In the US -||
7106|071|S|   Call your doctor for medical advice about side effects. You||
7106|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7106|073|S|www.fda.gov/medwatch.||
7106|074|S|   In Canada - Call your doctor for medical advice about side||
7106|075|S|effects. You may report side effects to Health Canada at||
7106|076|S|1-866-234-2345.||
7106|077|B|||
7106|078|P|PRECAUTIONS:  Before using vitamin K, tell your doctor or||
7106|079|P|pharmacist if you are allergic to it; or if you have any other||
7106|080|P|allergies. This product may contain inactive ingredients, which||
7106|081|P|can cause allergic reactions or other problems. Talk to your||
7106|082|P|pharmacist for more details.||
7106|083|P|   Before using this medication, tell your doctor or pharmacist||
7106|084|P|your medical history, especially of: blood disorders, kidney||
7106|085|P|disease, liver disease.||
7106|086|P|   This product may contain aluminum, which can rarely build up||
7106|087|P|to dangerous levels in the body. The risk may be increased if||
7106|088|P|this product is used for an extended time, especially in people||
7106|089|P|with kidney disease. Tell your doctor right away if you notice||
7106|090|P|any symptoms of too much aluminum in the body such as muscle||
7106|091|P|weakness, bone pain, or mental changes.||
7106|092|P|   Before having surgery, tell your doctor or dentist about all||
7106|093|P|the products you use (including prescription drugs,||
7106|094|P|nonprescription drugs, and herbal products).||
7106|095|P|   During pregnancy, this medication should be used only when||
7106|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
7106|097|P|   Vitamin K passes into breast milk, but is unlikely to harm a||
7106|098|P|nursing infant. Consult your doctor before breastfeeding.||
7106|099|B|||
7106|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7106|101|I|medications work or increase your risk for serious side effects.||
7106|102|I|This document does not contain all possible drug interactions.||
7106|103|I|Keep a list of all the products you use (including||
7106|104|I|prescription/nonprescription drugs and herbal products) and share||
7106|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
7106|106|I|the dosage of any medicines without your doctor's approval.||
7106|107|I|   Some products that may interact with this drug include: "blood||
7106|108|I|thinners" (such as warfarin).||
7106|109|B|||
7106|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7106|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7106|112|O|poison control center right away. US residents can call||
7106|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7106|114|B|||
7106|115|N|NOTES:  Lab and/or medical tests (such as prothrombin time, INR)||
7106|116|N|should be done while you are using this medication. Keep all||
7106|117|N|medical and lab appointments. Consult your doctor for more||
7106|118|N|details.||
7106|119|N|   Vitamin K is commonly found in leafy green vegetables such as||
7106|120|N|spinach, collards, and broccoli. Follow any dietary guidelines||
7106|121|N|recommended by your health care professional.||
7106|122|B|||
7106|123|D|MISSED DOSE:  It is important to get each dose of this medication||
7106|124|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7106|125|D|right away for a new dosing schedule. Do not double the dose to||
7106|126|D|catch up.||
7106|127|B|||
7106|128|R|STORAGE:  Store at room temperature away from light. Discard any||
7106|129|R|unused portion from single use containers. Keep all medications||
7106|130|R|away from children and pets.||
7106|131|R|   Do not flush medications down the toilet or pour them into a||
7106|132|R|drain unless instructed to do so. Properly discard this product||
7106|133|R|when it is expired or no longer needed. Consult your pharmacist||
7106|134|R|or local waste disposal company.||
7106|135|B|||
7106|136|A|Information last revised October 2024.||
7106|137|A|Copyright(c) 2025 First Databank, Inc.||
7106|138|B|||
7108|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7108|002|Z|does NOT have all possible information about this product. This||
7108|003|Z|information does not assure that this product is safe, effective,||
7108|004|Z|or appropriate for you. This information is not individual||
7108|005|Z|medical advice and does not substitute for the advice of your||
7108|006|Z|health care professional. Always ask your health care||
7108|007|Z|professional for complete information about this product and your||
7108|008|Z|specific health needs.||
7108|009|B|||
7108|010|T|TACROLIMUS - INJECTION||
7108|011|F|(ta-KROE-li-mus)||
7108|012|B|||
7108|013|C|COMMON BRAND NAME(S): Prograf||
7108|014|B|||
7108|015|W|WARNING:  Tacrolimus lowers the body's ability to fight an||
7108|016|W|infection/disease (immunosuppression). This effect may increase||
7108|017|W|your risk of developing an infection or certain types of cancer||
7108|018|W|(such as skin cancer, lymphoma). To reduce the risk of these||
7108|019|W|serious side effects, your doctor will direct you to receive this||
7108|020|W|medication at the lowest effective dose and monitor you closely.||
7108|021|W|Keep all medical and lab appointments.||
7108|022|W|   Tell your doctor right away if you develop any of the||
7108|023|W|following signs: unusual skin changes, change in the||
7108|024|W|appearance/size of moles, unusual growths/lumps, swollen lymph||
7108|025|W|nodes, night sweats, unexplained weight loss, signs of infection||
7108|026|W|(such as sore throat that doesn't go away, fever, chills).||
7108|027|B|||
7108|028|U|USES:  Tacrolimus is used with other medications to prevent||
7108|029|U|rejection of a kidney, heart, liver, or lung transplant. The||
7108|030|U|injection form of the medication is used when you cannot take the||
7108|031|U|medication by mouth. As soon possible, your doctor will switch||
7108|032|U|you to the form of this medication that is taken by mouth. This||
7108|033|U|medication belongs to a class of drugs known as||
7108|034|U|immunosuppressants. It works by weakening your body's defense||
7108|035|U|system (immune system) to help your body accept the new organ as||
7108|036|U|if it were your own.||
7108|037|B|||
7108|038|V|OTHER USES:  This section contains uses of this drug that are not||
7108|039|V|listed in the approved professional labeling for the drug but||
7108|040|V|that may be prescribed by your health care professional. Use this||
7108|041|V|drug for a condition that is listed in this section only if it||
7108|042|V|has been so prescribed by your health care professional.||
7108|043|V|   This drug may also be used for a certain type of bowel||
7108|044|V|condition (severe fulminant Crohn's disease) in people who have||
7108|045|V|not been successfully treated by the usual treatment.||
7108|046|B|||
7108|047|H|HOW TO USE:  This medication is given by injection into a vein by||
7108|048|H|a health care professional.||
7108|049|H|   The dosage is based on your weight, medical condition, lab||
7108|050|H|tests (such as tacrolimus trough levels), and response to||
7108|051|H|treatment.||
7108|052|H|   Tell your doctor if your condition gets worse.||
7108|053|B|||
7108|054|S|SIDE EFFECTS:  See also Warning section.||
7108|055|S|   Shaking (tremor), headache, diarrhea, nausea/vomiting, upset||
7108|056|S|stomach, loss of appetite, trouble sleeping, or numbness/tingling||
7108|057|S|hands/feet may occur. If any of these effects last or get worse,||
7108|058|S|tell your doctor or pharmacist promptly.||
7108|059|S|   Remember that this medication has been prescribed because your||
7108|060|S|doctor has judged that the benefit to you is greater than the||
7108|061|S|risk of side effects. Many people using this medication do not||
7108|062|S|have serious side effects.||
7108|063|S|   Tell your doctor right away if you have any serious side||
7108|064|S|effects, including: signs of kidney problems (such as change in||
7108|065|S|the amount of urine), mental/mood changes (such as anxiety,||
7108|066|S|agitation), pounding heartbeat, symptoms of heart failure (such||
7108|067|S|as shortness of breath, swelling ankles/feet, unusual tiredness,||
7108|068|S|unusual/sudden weight gain), muscle spasm/weakness, hearing||
7108|069|S|problems (such as hearing loss, ringing in the ears),||
7108|070|S|pain/redness/swelling at injection site or in the arms/legs,||
7108|071|S|dizziness, easy bruising/bleeding, signs of liver problems (such||
7108|072|S|as nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
7108|073|S|urine, stomach/abdominal pain), severe leg pain.||
7108|074|S|   This medication may also increase your risk of getting a rare||
7108|075|S|but very serious (sometimes fatal) brain infection (progressive||
7108|076|S|multifocal leukoencephalopathy-PML). Get medical help right away||
7108|077|S|if any of these rare but very serious side effects occur:||
7108|078|S|clumsiness, loss of coordination, weakness, sudden change in your||
7108|079|S|thinking (such as confusion, difficulty concentrating),||
7108|080|S|difficulty moving your muscles, problems with speech, seizure,||
7108|081|S|vision changes.||
7108|082|S|   Get medical help right away if you have any very serious side||
7108|083|S|effects, including: fainting, fast/irregular heartbeat, severe||
7108|084|S|dizziness, chest pain, black stools, vomit that looks like coffee||
7108|085|S|grounds.||
7108|086|S|   This medication may raise your blood pressure. Check your||
7108|087|S|blood pressure regularly and tell your doctor if the results are||
7108|088|S|high. Your doctor may control your blood pressure with||
7108|089|S|medication.||
7108|090|S|   Tacrolimus may cause diabetes. Tell your doctor or pharmacist||
7108|091|S|if you experience any of the following symptoms of high blood||
7108|092|S|sugar: increased thirst/hunger, frequent urination.||
7108|093|S|   A very serious allergic reaction to this drug is rare.||
7108|094|S|However, get medical help right away if you notice any symptoms||
7108|095|S|of a serious allergic reaction, including: rash, itching/swelling||
7108|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7108|097|S|breathing.||
7108|098|S|   This is not a complete list of possible side effects. If you||
7108|099|S|notice other effects not listed above, contact your doctor or||
7108|100|S|pharmacist.||
7108|101|S|   In the US -||
7108|102|S|   Call your doctor for medical advice about side effects. You||
7108|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7108|104|S|www.fda.gov/medwatch.||
7108|105|S|   In Canada - Call your doctor for medical advice about side||
7108|106|S|effects. You may report side effects to Health Canada at||
7108|107|S|1-866-234-2345.||
7108|108|B|||
7108|109|P|PRECAUTIONS:  Before receiving tacrolimus, tell your doctor or||
7108|110|P|pharmacist if you are allergic to it; or to other macrolide||
7108|111|P|medications (such as sirolimus); or if you have any other||
7108|112|P|allergies. This product may contain inactive ingredients (such as||
7108|113|P|polyoxyl 60 hydrogenated castor oil), which can cause allergic||
7108|114|P|reactions or other problems. Talk to your pharmacist for more||
7108|115|P|details.||
7108|116|P|   Before using this medication, tell your doctor or pharmacist||
7108|117|P|your medical history, especially of: kidney disease, liver||
7108|118|P|disease, high blood pressure, diabetes, mineral imbalances (such||
7108|119|P|as high potassium), any recent/current infections, cancer.||
7108|120|P|   Tacrolimus may cause a condition that affects the heart rhythm||
7108|121|P|(QT prolongation). QT prolongation can rarely cause serious||
7108|122|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
7108|123|P|as severe dizziness, fainting) that need medical attention right||
7108|124|P|away.||
7108|125|P|   The risk of QT prolongation may be increased if you have||
7108|126|P|certain medical conditions or are taking other drugs that may||
7108|127|P|cause QT prolongation. Before using tacrolimus, tell your doctor||
7108|128|P|or pharmacist of all the drugs you take and if you have any of||
7108|129|P|the following conditions: certain heart problems (heart failure,||
7108|130|P|slow heartbeat, QT prolongation in the EKG), family history of||
7108|131|P|certain heart problems (QT prolongation in the EKG, sudden||
7108|132|P|cardiac death).||
7108|133|P|   Low levels of potassium or magnesium in the blood may also||
7108|134|P|increase your risk of QT prolongation. This risk may increase if||
7108|135|P|you use certain drugs (such as diuretics/"water pills") or if you||
7108|136|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7108|137|P|Talk to your doctor about using tacrolimus safely.||
7108|138|P|   This medication may increase your risk of developing skin||
7108|139|P|cancer. Limit your time in the sun. Avoid tanning booths and||
7108|140|P|sunlamps. Use sunscreen and wear protective clothing when||
7108|141|P|outdoors.||
7108|142|P|   Tacrolimus can make you more likely to get infections or may||
7108|143|P|make current infections worse. Stay away from anyone who has an||
7108|144|P|infection that may easily spread (such as chickenpox, COVID-19,||
7108|145|P|measles, flu). Talk to your doctor if you have been exposed to an||
7108|146|P|infection or for more details.||
7108|147|P|   Tell your health care professional that you are using||
7108|148|P|tacrolimus before having any immunizations/vaccinations. Avoid||
7108|149|P|contact with people who have recently received live vaccines||
7108|150|P|(such as flu vaccine inhaled through the nose).||
7108|151|P|   This drug may increase your potassium levels. Before using||
7108|152|P|potassium supplements or salt substitutes containing potassium,||
7108|153|P|consult your doctor or pharmacist.||
7108|154|P|   Before having surgery, tell your doctor or dentist about all||
7108|155|P|the products you use (including prescription drugs,||
7108|156|P|nonprescription drugs, and herbal products).||
7108|157|P|   Older adults may be more sensitive to the side effects of this||
7108|158|P|drug, especially QT prolongation (see above).||
7108|159|P|   Tell your doctor if you are pregnant or plan to become||
7108|160|P|pregnant. You should not become pregnant while using tacrolimus.||
7108|161|P|Tacrolimus may harm an unborn baby. Men and women using this||
7108|162|P|medication should ask about reliable forms of birth control||
7108|163|P|before and during treatment. If you or your partner becomes||
7108|164|P|pregnant, talk to your doctor right away about the risks and||
7108|165|P|benefits of this medication.||
7108|166|P|   This drug passes into breast milk and the effect on a nursing||
7108|167|P|infant is unknown. Consult your doctor before breastfeeding.||
7108|168|B|||
7108|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7108|170|I|medications work or increase your risk for serious side effects.||
7108|171|I|This document does not contain all possible drug interactions.||
7108|172|I|Keep a list of all the products you use (including||
7108|173|I|prescription/nonprescription drugs and herbal products) and share||
7108|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
7108|175|I|the dosage of any medicines without your doctor's approval.||
7108|176|I|   Some products that may interact with this drug include:||
7108|177|I|cyclosporine, sirolimus, temsirolimus, ziprasidone, other drugs||
7108|178|I|that may increase the level of potassium in the blood (such as||
7108|179|I|"water pills" including amiloride, spironolactone), other drugs||
7108|180|I|that weaken the immune system/increase the risk of infection||
7108|181|I|(such as natalizumab, rituximab).||
7108|182|I|   Other medications can affect the removal of tacrolimus from||
7108|183|I|your body, which may affect how tacrolimus works. Examples||
7108|184|I|include azole antifungals (such as itraconazole, voriconazole),||
7108|185|I|cimetidine, danazol, ethinyl estradiol, methylprednisolone,||
7108|186|I|nefazodone, HIV protease inhibitors (such as nelfinavir),||
7108|187|I|rifamycins (such as rifampin, rifabutin), ritonavir, St. John's||
7108|188|I|wort, certain anti-seizure drugs (such as phenobarbital,||
7108|189|I|phenytoin), among others.||
7108|190|B|||
7108|191|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7108|192|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7108|193|O|poison control center right away. US residents can call||
7108|194|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7108|195|B|||
7108|196|N|NOTES:  Lab and/or medical tests (such as potassium levels, blood||
7108|197|N|pressure, blood sugar, tacrolimus blood level, kidney/liver||
7108|198|N|function) will be done while you are using this medication. Keep||
7108|199|N|all medical and lab appointments. Consult your doctor for more||
7108|200|N|details.||
7108|201|N|   If you have had an organ transplant, it is recommended that||
7108|202|N|you attend a transplant education class or support group. Learn||
7108|203|N|the signs of organ rejection such as tenderness/pain around the||
7108|204|N|transplanted organ, a feeling of being ill, or fever. Tell your||
7108|205|N|doctor right away if you notice any of these signs.||
7108|206|B|||
7108|207|D|MISSED DOSE:  It is important to get each dose of this medication||
7108|208|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7108|209|D|right away for a new dosing schedule.||
7108|210|B|||
7108|211|R|STORAGE:  Not applicable. This medication is given in a clinic||
7108|212|R|and will not be stored at home.||
7108|213|B|||
7108|214|M|MEDICAL ALERT:  Your condition can cause complications in a||
7108|215|M|medical emergency. For information about enrolling in MedicAlert,||
7108|216|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7108|217|B|||
7108|218|A|Information last revised May 2025.||
7108|219|A|Copyright(c) 2025 First Databank, Inc.||
7108|220|B|||
7109|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7109|002|Z|does NOT have all possible information about this product. This||
7109|003|Z|information does not assure that this product is safe, effective,||
7109|004|Z|or appropriate for you. This information is not individual||
7109|005|Z|medical advice and does not substitute for the advice of your||
7109|006|Z|health care professional. Always ask your health care||
7109|007|Z|professional for complete information about this product and your||
7109|008|Z|specific health needs.||
7109|009|B|||
7109|010|T|BISACODYL SUPPOSITORY - RECTAL||
7109|011|F|(bis-AK-oh-dil)||
7109|012|B|||
7109|013|C|COMMON BRAND NAME(S): Dulcolax, Fleet Bisacodyl, Magic Bullet||
7109|014|B|||
7109|015|U|USES:  This product is used to treat constipation. However,||
7109|016|U|milder products (such as laxatives taken by mouth) should be used||
7109|017|U|whenever possible for constipation. Bisacodyl is a stimulant||
7109|018|U|laxative that works by increasing the amount of fluid/salts in||
7109|019|U|the intestines. This effect usually results in a bowel movement||
7109|020|U|within 15 to 60 minutes.||
7109|021|U|   The normal frequency of bowel movements varies from once daily||
7109|022|U|to 1 to 2 times weekly. Constipation is best treated by drinking||
7109|023|U|plenty of fluids (four to six 8-ounce glasses daily), eating||
7109|024|U|foods high in fiber, and exercising regularly.||
7109|025|U|   This product is not recommended for use in children younger||
7109|026|U|than 6 years unless directed by a doctor.||
7109|027|B|||
7109|028|H|HOW TO USE:  This product is for rectal use only. Read and follow||
7109|029|H|all directions on the product package or use as directed by your||
7109|030|H|doctor. If you have any questions, ask your doctor or pharmacist.||
7109|031|H|If the suppository is too soft to insert, chill in the||
7109|032|H|refrigerator for 30 minutes or run cold water over it before||
7109|033|H|removing the foil wrapper.||
7109|034|H|   Wash your hands before and after using this product. Remove||
7109|035|H|the foil wrapper. If desired, the suppository may be moistened||
7109|036|H|with lukewarm water. Do not use petroleum jelly or mineral oil.||
7109|037|H|Doing so may cause the product to be less effective. Lie on your||
7109|038|H|left side with the right knee slightly bent. Gently insert the||
7109|039|H|suppository, pointed end first, toward the navel and well up into||
7109|040|H|the rectum. After insertion, stay in position for 15 to 20||
7109|041|H|minutes if possible until you feel a strong urge to have a bowel||
7109|042|H|movement.||
7109|043|H|   If this product is used too often, it may cause loss of normal||
7109|044|H|bowel function and an inability to have a bowel movement without||
7109|045|H|using the product (laxative dependence). If you notice symptoms||
7109|046|H|of overuse such as diarrhea, abdominal pain, decreased weight, or||
7109|047|H|weakness, contact your doctor promptly.||
7109|048|H|   Consult your doctor promptly if you do not have a bowel||
7109|049|H|movement after using this product or if you think you may have a||
7109|050|H|serious medical problem.||
7109|051|B|||
7109|052|S|SIDE EFFECTS:  Rectal irritation/burning/itching, mild abdominal||
7109|053|S|discomfort/cramps, or nausea may occur. If any of these effects||
7109|054|S|last or get worse, tell your doctor or pharmacist promptly.||
7109|055|S|   If your doctor has directed you to use this product, remember||
7109|056|S|that your doctor has judged that the benefit to you is greater||
7109|057|S|than the risk of side effects. Many people using this product do||
7109|058|S|not have serious side effects.||
7109|059|S|   Tell your doctor right away if you have any serious side||
7109|060|S|effects, including: diarrhea that doesn't stop, rectal||
7109|061|S|bleeding/blisters.||
7109|062|S|   Diarrhea that doesn't stop may result in dehydration. Contact||
7109|063|S|your doctor promptly if you notice any symptoms of dehydration||
7109|064|S|such as unusual decreased urination, unusual dry mouth/thirst,||
7109|065|S|fast heartbeat, or dizziness/lightheadedness.||
7109|066|S|   A very serious allergic reaction to this drug is rare.||
7109|067|S|However, get medical help right away if you notice any symptoms||
7109|068|S|of a serious allergic reaction, including: rash, itching/swelling||
7109|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7109|070|S|breathing.||
7109|071|S|   This is not a complete list of possible side effects. If you||
7109|072|S|notice other effects not listed above, contact your doctor or||
7109|073|S|pharmacist.||
7109|074|S|   In the US -||
7109|075|S|   Call your doctor for medical advice about side effects. You||
7109|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7109|077|S|www.fda.gov/medwatch.||
7109|078|S|   In Canada - Call your doctor for medical advice about side||
7109|079|S|effects. You may report side effects to Health Canada at||
7109|080|S|1-866-234-2345.||
7109|081|B|||
7109|082|P|PRECAUTIONS:  Before using bisacodyl, tell your doctor or||
7109|083|P|pharmacist if you are allergic to it; or if you have any other||
7109|084|P|allergies. This product may contain inactive ingredients, which||
7109|085|P|can cause allergic reactions or other problems. Talk to your||
7109|086|P|pharmacist for more details.||
7109|087|P|   Before using this product, tell your doctor or pharmacist your||
7109|088|P|medical history, especially of: other bowel problems (such as||
7109|089|P|blockage, ulcerative colitis, hemorrhoids, rectal bleeding),||
7109|090|P|current stomach/abdominal symptoms (such as nausea/vomiting that||
7109|091|P|doesn't stop, pain, cramping).||
7109|092|P|   Consult your doctor before using this product if you have had||
7109|093|P|a sudden change in bowel habits lasting more than 2 weeks, or if||
7109|094|P|you need to use a laxative for more than 1 week. These could be||
7109|095|P|symptoms of a serious medical problem.||
7109|096|P|   This product may be used during labor/delivery to clean the||
7109|097|P|bowels before the second stage of labor (pushing phase). At other||
7109|098|P|times during pregnancy, this product should be used only when||
7109|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
7109|100|P|   It is unknown if this drug passes into breast milk. Consult||
7109|101|P|your doctor before breastfeeding.||
7109|102|B|||
7109|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7109|104|I|medications work or increase your risk for serious side effects.||
7109|105|I|This document does not contain all possible drug interactions.||
7109|106|I|Keep a list of all the products you use (including||
7109|107|I|prescription/nonprescription drugs and herbal products) and share||
7109|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
7109|109|I|the dosage of any medicines without your doctor's approval.||
7109|110|I|   Some products that may interact with this drug are: other||
7109|111|I|laxatives (including castor oil, stool softeners, lubricants such||
7109|112|I|as mineral oil).||
7109|113|B|||
7109|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7109|115|O|has overdosed and has serious symptoms such as passing out or||
7109|116|O|trouble breathing, call 911. Otherwise, call a poison control||
7109|117|O|center right away. US residents can call 1-800-222-1222. Canada||
7109|118|O|residents can call 1-844-764-7669.||
7109|119|B|||
7109|120|N|NOTES:  Laxatives should be used only temporarily if needed for||
7109|121|N|constipation. High doses or frequent use can lead to ongoing||
7109|122|N|constipation and laxative dependence. (See also How to Use||
7109|123|N|section.)||
7109|124|B|||
7109|125|D|MISSED DOSE:  Not applicable.||
7109|126|B|||
7109|127|R|STORAGE:  Refer to storage information on the package label. If||
7109|128|R|you have any questions about storage, ask your pharmacist. Keep||
7109|129|R|all medications away from children and pets.||
7109|130|R|   Do not flush medications down the toilet or pour them into a||
7109|131|R|drain unless instructed to do so. Properly discard this product||
7109|132|R|when it is expired or no longer needed. Consult your pharmacist||
7109|133|R|or local waste disposal company.||
7109|134|B|||
7109|135|A|Information last revised January 2025.||
7109|136|A|Copyright(c) 2025 First Databank, Inc.||
7109|137|B|||
7115|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7115|002|Z|does NOT have all possible information about this product. This||
7115|003|Z|information does not assure that this product is safe, effective,||
7115|004|Z|or appropriate for you. This information is not individual||
7115|005|Z|medical advice and does not substitute for the advice of your||
7115|006|Z|health care professional. Always ask your health care||
7115|007|Z|professional for complete information about this product and your||
7115|008|Z|specific health needs.||
7115|009|B|||
7115|010|T|ETHINYL ESTRADIOL/CYPROTERONE - ORAL||
7115|011|F|(ETH-i-nil ES-tra-DYE-ol/sye-PROE-ter-one)||
7115|012|B|||
7115|013|W|WARNING:  This medication may increase your risk of getting rare||
7115|014|W|but very serious blood clots. It must not be used by women with a||
7115|015|W|history of blood clots. Because of this risk of blood clots, this||
7115|016|W|medication must not be used just for birth control. It should||
7115|017|W|also not be used with other hormone containing birth control||
7115|018|W|pills/patch/ring.||
7115|019|W|   Do not use this medication if you smoke cigarettes/use tobacco||
7115|020|W|and are over 35 years old. Smoking raises your risk of stroke,||
7115|021|W|heart attack, blood clots, and high blood pressure from hormonal||
7115|022|W|birth control (such as the pill, patch, ring). The risk of these||
7115|023|W|serious problems increases with age and with the number of||
7115|024|W|cigarettes you smoke. Do not smoke or use tobacco.||
7115|025|B|||
7115|026|U|USES:  See also Warning section.||
7115|027|U|   This medication is used to treat severe acne in women who have||
7115|028|U|an oily skin condition called seborrhea and unwanted/extra hair||
7115|029|U|growth on the body (such as face, chest). It contains 2 hormones:||
7115|030|U|cyproterone (a progestin) and ethinyl estradiol (an estrogen).||
7115|031|U|This medication helps to decrease the amount of oil on the skin||
7115|032|U|which helps to clear acne. It also decreases hair growth.||
7115|033|U|   Cyproterone also has anti-androgen (anti-testosterone)||
7115|034|U|effects. Testosterone is a hormone that can worsen acne and cause||
7115|035|U|extra hair growth. Cyproterone works by blocking testosterone.||
7115|036|U|Ethinyl estradiol is used to balance the effects of cyproterone||
7115|037|U|on the menstrual cycle. This medication is used when other acne||
7115|038|U|treatments have not worked.||
7115|039|U|   If taken daily as prescribed, these hormones prevent||
7115|040|U|pregnancy. This medication can also be used as a form of birth||
7115|041|U|control by women taking it mainly to treat severe acne with||
7115|042|U|seborrhea. However, this medication must not be used just for||
7115|043|U|birth control because of its risks of very serious side effects||
7115|044|U|(such as blood clots).||
7115|045|U|   This medication does not protect against sexually transmitted||
7115|046|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
7115|047|U|an effective barrier method (latex or polyurethane condom/dental||
7115|048|U|dams) during sexual activity will help to decrease your risk of||
7115|049|U|infection.||
7115|050|B|||
7115|051|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
7115|052|H|your pharmacist before you start using this product and each time||
7115|053|H|you get a refill. The leaflet contains very important information||
7115|054|H|on when to take your medication and what to do if you miss a||
7115|055|H|dose. If you have any questions, ask your doctor or pharmacist.||
7115|056|H|   Take this medication by mouth as directed by your doctor,||
7115|057|H|usually once daily. Pick a time of day that is easy for you to||
7115|058|H|remember, and take your medication at the same time each day.||
7115|059|H|   Each pack contains 21 tablets. If this is your first time||
7115|060|H|using this medication, take your first tablet on the first day of||
7115|061|H|your menstrual period, and continue to take 1 tablet once daily||
7115|062|H|for 21 days in a row until the pack is finished. Then, do not||
7115|063|H|take any tablets for 7 days unless directed by your doctor. You||
7115|064|H|should have your period during the 7 days without medication.||
7115|065|H|After you have gone 7 days without taking this medication, start||
7115|066|H|a new pack the next day whether or not you have your period.||
7115|067|H|   Start each new pack/cycle on the same day of the week that you||
7115|068|H|started the previous pack/cycle, even if you are still having||
7115|069|H|your period. If you do not get your period, contact your doctor.||
7115|070|H|   According to the manufacturer, you should not use this||
7115|071|H|medication long-term. Once the acne has improved, stop this||
7115|072|H|medication 3 to 4 cycles later. Ask your doctor or pharmacist for||
7115|073|H|more details.||
7115|074|H|   It may take up to several months before you get the full||
7115|075|H|benefit of this drug. Tell your doctor if your condition lasts or||
7115|076|H|gets worse.||
7115|077|H|   Pregnancy is more likely if you miss pills, start a new||
7115|078|H|pack/cycle late, or take your pill at a different time of day||
7115|079|H|than usual. Vomiting and diarrhea may also make this medication||
7115|080|H|work less well. Talk to your doctor if you have vomiting or||
7115|081|H|diarrhea to see if you need to start using a backup birth control||
7115|082|H|method. See also Missed Dose section.||
7115|083|B|||
7115|084|S|SIDE EFFECTS:  Nausea, vomiting, headache, stomach||
7115|085|S|cramping/bloating, dizziness, vaginal discomfort/irritation,||
7115|086|S|increased vaginal fluids, changes in sexual interest, or breast||
7115|087|S|tenderness/enlargement may occur. Vaginal bleeding between||
7115|088|S|periods (called breakthrough bleeding or spotting) and irregular||
7115|089|S|periods may also occur as your body adjusts to the medication. If||
7115|090|S|you do not have bleeding during the 7 days when you are not||
7115|091|S|taking the medication, ask your doctor for a pregnancy test. If||
7115|092|S|any of these effects last or get worse, tell your doctor or||
7115|093|S|pharmacist promptly.||
7115|094|S|   Remember that this medication has been prescribed because your||
7115|095|S|doctor has judged that the benefit to you is greater than the||
7115|096|S|risk of side effects. Many people using this medication do not||
7115|097|S|have serious side effects.||
7115|098|S|   This medication may raise your blood pressure. Check your||
7115|099|S|blood pressure regularly and tell your doctor if the results are||
7115|100|S|high.||
7115|101|S|   Tell your doctor right away if you have any serious side||
7115|102|S|effects, including: changes in vaginal bleeding (such as||
7115|103|S|continuous spotting, sudden heavy bleeding, missed periods), dark||
7115|104|S|patches on the skin (melasma), swelling of the ankles/feet,||
7115|105|S|weight changes (gain or loss), butterfly-shaped rash around the||
7115|106|S|nose and cheeks, signs of liver problems (such as nausea/vomiting||
7115|107|S|that doesn't stop, unusual tiredness, dark urine, yellowing||
7115|108|S|eyes/skin), joint pain/swelling.||
7115|109|S|   Get medical help right away if you have any very serious side||
7115|110|S|effects, including: new/worsening seizures, severe||
7115|111|S|stomach/abdominal/pelvic pain or swelling, breast lumps,||
7115|112|S|mental/mood changes (such as depression, suicidal thoughts).||
7115|113|S|   This medication may rarely cause serious (sometimes fatal)||
7115|114|S|problems from blood clots (such as heart attack, stroke, blood||
7115|115|S|clots in the lungs or legs). Get medical help right away if you||
7115|116|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
7115|117|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
7115|118|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
7115|119|S|trouble speaking, weakness on one side of the body, sudden vision||
7115|120|S|changes.||
7115|121|S|   A very serious allergic reaction to this drug is rare.||
7115|122|S|However, get medical help right away if you notice any symptoms||
7115|123|S|of a serious allergic reaction, including: rash, itching/swelling||
7115|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7115|125|S|breathing.||
7115|126|S|   This is not a complete list of possible side effects. If you||
7115|127|S|notice other effects not listed above, contact your doctor or||
7115|128|S|pharmacist.||
7115|129|S|   In the US -||
7115|130|S|   Call your doctor for medical advice about side effects. You||
7115|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7115|132|S|www.fda.gov/medwatch.||
7115|133|S|   In Canada - Call your doctor for medical advice about side||
7115|134|S|effects. You may report side effects to Health Canada at||
7115|135|S|1-866-234-2345.||
7115|136|B|||
7115|137|P|PRECAUTIONS:  See also Warning section.||
7115|138|P|   Before using this medication, tell your doctor or pharmacist||
7115|139|P|if you are allergic to it; or to other birth control||
7115|140|P|pills/patch/ring or hormone products (estrogens/progestins); or||
7115|141|P|if you have any other allergies. This product may contain||
7115|142|P|inactive ingredients, which can cause allergic reactions or other||
7115|143|P|problems. Talk to your pharmacist for more details.||
7115|144|P|   Before using this medication, tell your doctor or pharmacist||
7115|145|P|your medical history, especially of: blood clots (such as in the||
7115|146|P|legs, eyes, lungs), close family history of blood clots, blood||
7115|147|P|clotting disorders (such as protein C or protein S deficiency),||
7115|148|P|stroke, high blood pressure, cancer (especially of the breast,||
7115|149|P|ovary, uterus, or the brain coverings-meningioma), diabetes,||
7115|150|P|headaches/migraines, heart problems (such as heart attack, chest||
7115|151|P|pain, heart failure, heart valve disease), liver problems (such||
7115|152|P|as liver tumor, active liver disease, cholestatic jaundice),||
7115|153|P|history of yellowing eyes/skin (jaundice) during pregnancy or||
7115|154|P|while using birth control pills, vaginal bleeding of unknown||
7115|155|P|cause, a certain eye problem (loss of vision caused by blood||
7115|156|P|vessel disease in the eye), a certain type of hearing loss||
7115|157|P|worsened by pregnancy (otosclerosis), high blood cholesterol/fat||
7115|158|P|(triglyceride) levels, depression, swelling (edema), family or||
7115|159|P|personal history of a certain swelling disorder (angioedema),||
7115|160|P|gallbladder problems, kidney disease, obesity, underactive||
7115|161|P|thyroid (hypothyroidism), fibroids of the uterus.||
7115|162|P|   If you have diabetes, this medication may affect your blood||
7115|163|P|sugar. Check your blood sugar regularly as directed and share the||
7115|164|P|results with your doctor. Tell your doctor right away if you have||
7115|165|P|symptoms of high blood sugar such as increased thirst/urination.||
7115|166|P|Your doctor may need to adjust your diabetes medication, exercise||
7115|167|P|program, or diet.||
7115|168|P|   Tell your doctor if you just had or will be having surgery or||
7115|169|P|if you will be confined to a bed or chair for a long time (such||
7115|170|P|as a long plane flight). These conditions increase your risk of||
7115|171|P|getting blood clots, especially if you are using hormonal birth||
7115|172|P|control. You may need to stop this medication for a time or take||
7115|173|P|special precautions.||
7115|174|P|   Before having surgery, tell your doctor or dentist about all||
7115|175|P|the products you use (including prescription drugs,||
7115|176|P|nonprescription drugs, and herbal products).||
7115|177|P|   This medication may cause blotchy, dark areas on your face and||
7115|178|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
7115|179|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
7115|180|P|wear protective clothing when outdoors.||
7115|181|P|   If you are nearsighted or wear contact lenses, you may develop||
7115|182|P|vision problems or trouble wearing your contact lenses. Contact||
7115|183|P|your eye doctor if these problems occur.||
7115|184|P|   It may take longer for you to become pregnant after you stop||
7115|185|P|taking birth control pills. Consult your doctor.||
7115|186|P|   This medication should not be used during pregnancy. If you||
7115|187|P|become pregnant or think you may be pregnant, tell your doctor||
7115|188|P|right away. If you have just given birth or had a pregnancy||
7115|189|P|loss/abortion after the first 3 months, talk with your doctor||
7115|190|P|about reliable forms of birth control, and find out when it is||
7115|191|P|safe to start using birth control that contains a form of||
7115|192|P|estrogen, such as this medication.||
7115|193|P|   This medication passes into breast milk and may harm a nursing||
7115|194|P|infant. Breastfeeding is not recommended while using this||
7115|195|P|medication. Consult your doctor before breastfeeding.||
7115|196|B|||
7115|197|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7115|198|I|medications work or increase your risk for serious side effects.||
7115|199|I|This document does not contain all possible drug interactions.||
7115|200|I|Keep a list of all the products you use (including||
7115|201|I|prescription/nonprescription drugs and herbal products) and share||
7115|202|I|it with your doctor and pharmacist. Do not start, stop, or change||
7115|203|I|the dosage of any medicines without your doctor's approval.||
7115|204|I|   Some products that may interact with this drug include:||
7115|205|I|aromatase inhibitors (such as anastrozole, exemestane), "blood||
7115|206|I|thinners" (anticoagulants such as warfarin), other birth control||
7115|207|I|pills/patch/ring, other hormone products (products that contain||
7115|208|I|estrogens or progestins), fezolinetant, raloxifene, ospemifene,||
7115|209|I|tamoxifen, tizanidine, tranexamic acid.||
7115|210|I|   Some drugs may cause hormonal birth control to work less well||
7115|211|I|by decreasing the amount of birth control hormones in your body.||
7115|212|I|This effect can result in pregnancy. Examples include||
7115|213|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
7115|214|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
7115|215|I|seizures (such as barbiturates, carbamazepine, felbamate,||
7115|216|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
7115|217|I|nevirapine), among others.||
7115|218|I|   Tell your doctor when you start any new drug, and discuss if||
7115|219|I|you should use reliable backup birth control. Also tell your||
7115|220|I|doctor if you have any new spotting or breakthrough bleeding,||
7115|221|I|because these may be signs that your birth control is not working||
7115|222|I|well.||
7115|223|I|   This medication can speed up or slow down the removal of other||
7115|224|I|medications from your body, which may affect how they work.||
7115|225|I|Examples of affected drugs include aspirin, certain beta blockers||
7115|226|I|(such as metoprolol), clofibrate, corticosteroids (such as||
7115|227|I|prednisolone), certain benzodiazepines (such as lorazepam,||
7115|228|I|temazepam), among others.||
7115|229|I|   This medication may interfere with certain lab tests (such as||
7115|230|I|blood tests for clotting factors, thyroid), possibly causing||
7115|231|I|false test results. Make sure lab personnel and all your doctors||
7115|232|I|know you use this drug.||
7115|233|B|||
7115|234|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7115|235|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7115|236|O|poison control center right away. US residents can call||
7115|237|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7115|238|O|Symptoms of overdose may include: severe nausea/vomiting,||
7115|239|O|sudden/unusual vaginal bleeding.||
7115|240|B|||
7115|241|N|NOTES:  Do not share this medication with others.||
7115|242|N|   Regular complete physical exams which include lab and/or||
7115|243|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
7115|244|N|Pap smear) should be done while you are taking this medication.||
7115|245|N|Follow your doctor's instructions for examining your breasts, and||
7115|246|N|report any lumps right away. Keep all medical and lab||
7115|247|N|appointments. Consult your doctor for more details.||
7115|248|B|||
7115|249|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7115|250|D|remember. If it is more than 12 hours after the missed dose,||
7115|251|D|throw away the missed tablet. Take your next dose at the regular||
7115|252|D|time. Do not double the dose to catch up.||
7115|253|D|   If you miss a dose, you must use backup birth control (such as||
7115|254|D|condoms, spermicide) until the pack is finished to prevent||
7115|255|D|pregnancy. Ask your doctor or pharmacist if you have any||
7115|256|D|questions.||
7115|257|D|   If you often forget to take your pills as directed, contact||
7115|258|D|your doctor to discuss switching to another form of birth||
7115|259|D|control.||
7115|260|B|||
7115|261|R|STORAGE:  Store at room temperature away from light and moisture.||
7115|262|R|Do not store in the bathroom. Keep all medications away from||
7115|263|R|children and pets.||
7115|264|R|   Do not flush medications down the toilet or pour them into a||
7115|265|R|drain unless instructed to do so. Properly discard this product||
7115|266|R|when it is expired or no longer needed. Consult your pharmacist||
7115|267|R|or local waste disposal company.||
7115|268|B|||
7115|269|A|Information last revised October 2025.||
7115|270|A|Copyright(c) 2025 First Databank, Inc.||
7115|271|B|||
7116|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7116|002|Z|does NOT have all possible information about this product. This||
7116|003|Z|information does not assure that this product is safe, effective,||
7116|004|Z|or appropriate for you. This information is not individual||
7116|005|Z|medical advice and does not substitute for the advice of your||
7116|006|Z|health care professional. Always ask your health care||
7116|007|Z|professional for complete information about this product and your||
7116|008|Z|specific health needs.||
7116|009|B|||
7116|010|T|TESTOSTERONE UNDECANOATE - ORAL||
7116|011|F|(tess-TOSS-ter-own un-deck-ah-NO-ate)||
7116|012|B|||
7116|013|C|COMMON BRAND NAME(S): Jatenzo, Kyzatrex, Tlando||
7116|014|B|||
7116|015|W|WARNING:  This medication can raise your blood pressure. High||
7116|016|W|blood pressure can increase your risk of serious (even fatal)||
7116|017|W|heart and blood vessel problems (such as heart attack, stroke).||
7116|018|W|Your risk may be greater if you have heart disease or if you have||
7116|019|W|other conditions that increase your risk, such as high blood||
7116|020|W|pressure. Check your blood pressure regularly and tell your||
7116|021|W|doctor if the results are high. Your doctor may prescribe||
7116|022|W|medication(s) to control your blood pressure, or may decrease or||
7116|023|W|stop this medication. Talk with your doctor about the risks and||
7116|024|W|benefits of taking testosterone.||
7116|025|B|||
7116|026|U|USES:  This medication is used by men who have low or no||
7116|027|U|testosterone due to certain medical conditions (such as||
7116|028|U|hypogonadism). Testosterone belongs to a class of drugs known as||
7116|029|U|androgens. It helps the body to develop and maintain male sexual||
7116|030|U|characteristics (masculinity), such as a deep voice and body||
7116|031|U|hair. It also helps to maintain muscle and prevent bone loss, and||
7116|032|U|is needed for natural sexual ability/desire.||
7116|033|U|   This medication should not be used in women.||
7116|034|B|||
7116|035|H|HOW TO USE:  Read the Medication Guide provided by your||
7116|036|H|pharmacist before you start taking/using testosterone and each||
7116|037|H|time you get a refill. If you have any questions, ask your doctor||
7116|038|H|or pharmacist.||
7116|039|H|   Take this medication by mouth with food as directed by your||
7116|040|H|doctor, usually twice daily. Some brands should not be chewed and||
7116|041|H|should be swallowed whole for the best effect. Carefully follow||
7116|042|H|your doctor's directions for taking your brand of this||
7116|043|H|medication.||
7116|044|H|   The dosage is based on your medical condition, lab tests, and||
7116|045|H|response to treatment.||
7116|046|H|   Use this medication regularly in order to get the most benefit||
7116|047|H|from it. To help you remember, take it at the same times each||
7116|048|H|day.||
7116|049|H|   Misuse or abuse of testosterone can cause serious side effects||
7116|050|H|such as heart disease (including heart attack), stroke, liver||
7116|051|H|disease, mental/mood problems, abnormal drug-seeking behavior, or||
7116|052|H|improper bone growth (in adolescents). Do not increase your dose||
7116|053|H|or use this drug more often or for longer than prescribed. If||
7116|054|H|testosterone is misused or abused, you may have withdrawal||
7116|055|H|symptoms (such as depression, irritability, tiredness) when you||
7116|056|H|suddenly stop using the drug. These symptoms may last from weeks||
7116|057|H|to months.||
7116|058|H|   Tell your doctor if your condition does not get better or if||
7116|059|H|it gets worse.||
7116|060|B|||
7116|061|S|SIDE EFFECTS:  See also Warning section.||
7116|062|S|   Nausea, vomiting, headache, skin color changes,||
7116|063|S|increased/decreased sexual interest, oily skin, hair loss, and||
7116|064|S|acne may occur. If any of these effects last or get worse, tell||
7116|065|S|your doctor or pharmacist promptly.||
7116|066|S|   Remember that this medication has been prescribed because your||
7116|067|S|doctor has judged that the benefit to you is greater than the||
7116|068|S|risk of side effects. Many people using this medication do not||
7116|069|S|have serious side effects.||
7116|070|S|   Tell your doctor right away if you have any serious side||
7116|071|S|effects, including: mental/mood changes (such as anxiety,||
7116|072|S|depression, increased anger), trouble sleeping/snoring (including||
7116|073|S|sleep apnea), signs of liver disease (such as nausea/vomiting||
7116|074|S|that doesn't stop, loss of appetite, stomach/abdominal pain,||
7116|075|S|yellowing eyes/skin, dark urine), hands/ankles/feet swelling,||
7116|076|S|unusual tiredness, fast/irregular heartbeat, trouble urinating,||
7116|077|S|increased urination (especially at night), breast||
7116|078|S|swelling/tenderness, too frequent/prolonged erections.||
7116|079|S|   Get medical help right away if you have any very serious side||
7116|080|S|effects, including: shortness of breath/rapid breathing,||
7116|081|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
7116|082|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
7116|083|S|sudden/severe headaches, trouble speaking, weakness on one side||
7116|084|S|of the body, sudden vision changes.||
7116|085|S|   Rarely, males may have a painful or prolonged erection lasting||
7116|086|S|4 or more hours. If this occurs, stop using this drug and get||
7116|087|S|medical help right away, or permanent problems could occur.||
7116|088|S|   A very serious allergic reaction to this drug is rare.||
7116|089|S|However, get medical help right away if you notice any symptoms||
7116|090|S|of a serious allergic reaction, including: rash, itching/swelling||
7116|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7116|092|S|breathing.||
7116|093|S|   This is not a complete list of possible side effects. If you||
7116|094|S|notice other effects not listed above, contact your doctor or||
7116|095|S|pharmacist.||
7116|096|S|   In the US -||
7116|097|S|   Call your doctor for medical advice about side effects. You||
7116|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7116|099|S|www.fda.gov/medwatch.||
7116|100|S|   In Canada - Call your doctor for medical advice about side||
7116|101|S|effects. You may report side effects to Health Canada at||
7116|102|S|1-866-234-2345.||
7116|103|B|||
7116|104|P|PRECAUTIONS:  Before using testosterone, tell your doctor or||
7116|105|P|pharmacist if you are allergic to it; or if you have any other||
7116|106|P|allergies. This product may contain inactive ingredients, which||
7116|107|P|can cause allergic reactions or other problems. Talk to your||
7116|108|P|pharmacist for more details.||
7116|109|P|   Before using this medication, tell your doctor or pharmacist||
7116|110|P|your medical history, especially of: cancer (such as breast||
7116|111|P|cancer in men, prostate cancer), blood clots (such as in the leg,||
7116|112|P|lungs), heart disease (such as heart failure, chest pain, heart||
7116|113|P|attack), stroke, liver problems, kidney problems, certain mineral||
7116|114|P|imbalance (high calcium blood level), high cholesterol, high||
7116|115|P|blood pressure, enlarged prostate, breathing problems (such as||
7116|116|P|sleep apnea, chronic obstructive pulmonary disease-COPD),||
7116|117|P|diabetes.||
7116|118|P|   If you have diabetes, this product may lower your blood sugar.||
7116|119|P|Check your blood sugar regularly as directed and share the||
7116|120|P|results with your doctor. Tell your doctor right away if you have||
7116|121|P|symptoms of low blood sugar, such as sudden sweating, shaking,||
7116|122|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
7116|123|P|hands/feet. Your doctor may need to adjust your diabetes||
7116|124|P|medication, exercise program, or diet.||
7116|125|P|   Before having surgery, tell your doctor or dentist about all||
7116|126|P|the products you use (including prescription drugs,||
7116|127|P|nonprescription drugs, and herbal products).||
7116|128|P|   Older adults may be more sensitive to the side effects of this||
7116|129|P|drug, especially prostate/liver problems, swelling of arms/legs.||
7116|130|P|   Children may be more sensitive to the side effects of this||
7116|131|P|drug. In children, it may affect bone growth. Monitor your||
7116|132|P|child's height periodically.||
7116|133|P|   This medication can affect fertility in males. Ask your doctor||
7116|134|P|for more details.||
7116|135|P|   This medication should not be used in women, especially during||
7116|136|P|pregnancy or breastfeeding. It may harm an unborn or||
7116|137|P|breastfeeding baby. Consult your doctor for more details.||
7116|138|B|||
7116|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7116|140|I|medications work or increase your risk for serious side effects.||
7116|141|I|This document does not contain all possible drug interactions.||
7116|142|I|Keep a list of all the products you use (including||
7116|143|I|prescription/nonprescription drugs and herbal products) and share||
7116|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
7116|145|I|the dosage of any medicines without your doctor's approval.||
7116|146|I|   Some products that may interact with this drug include: "blood||
7116|147|I|thinners" (such as warfarin).||
7116|148|I|   This medication may interfere with certain lab tests||
7116|149|I|(including thyroid function tests), possibly causing false test||
7116|150|I|results. Make sure lab personnel and all your doctors know you||
7116|151|I|use this drug.||
7116|152|B|||
7116|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7116|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7116|155|O|poison control center right away. US residents can call||
7116|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7116|157|B|||
7116|158|N|NOTES:  Do not share this medication with others. Sharing it is||
7116|159|N|against the law.||
7116|160|N|   Lab and/or medical tests (such as blood pressure, testosterone||
7116|161|N|levels, blood counts, liver function, cholesterol levels, PSA)||
7116|162|N|should be done while you are taking this medication. Keep all||
7116|163|N|medical and lab appointments.||
7116|164|B|||
7116|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7116|166|D|remember. If it is near the time of the next dose, skip the||
7116|167|D|missed dose. Take your next dose at the regular time. Do not||
7116|168|D|double the dose to catch up.||
7116|169|B|||
7116|170|R|STORAGE:  Store at room temperature away from light and moisture.||
7116|171|R|Do not store in the bathroom. Keep all medications away from||
7116|172|R|children and pets.||
7116|173|R|   Do not flush medications down the toilet or pour them into a||
7116|174|R|drain unless instructed to do so. Properly discard this product||
7116|175|R|when it is expired or no longer needed. Consult your pharmacist||
7116|176|R|or local waste disposal company.||
7116|177|B|||
7116|178|A|Information last revised May 2024.||
7116|179|A|Copyright(c) 2025 First Databank, Inc.||
7116|180|B|||
7117|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7117|002|Z|does NOT have all possible information about this product. This||
7117|003|Z|information does not assure that this product is safe, effective,||
7117|004|Z|or appropriate for you. This information is not individual||
7117|005|Z|medical advice and does not substitute for the advice of your||
7117|006|Z|health care professional. Always ask your health care||
7117|007|Z|professional for complete information about this product and your||
7117|008|Z|specific health needs.||
7117|009|B|||
7117|010|T|FOLIC ACID - INJECTION||
7117|011|F|(FOH-lick)||
7117|012|B|||
7117|013|C|COMMON BRAND NAME(S): Folvite||
7117|014|B|||
7117|015|U|USES:  Folic acid is used to treat or prevent certain anemias||
7117|016|U|caused by poor diet, pregnancy, alcoholism, liver disease,||
7117|017|U|certain stomach/intestinal problems, kidney dialysis, or other||
7117|018|U|conditions. This medication helps to relieve symptoms such as||
7117|019|U|unusual tiredness and diarrhea that can occur with these types of||
7117|020|U|anemias. Women of childbearing age should maintain adequate||
7117|021|U|amounts of folic acid either through diet or supplements to||
7117|022|U|prevent spinal cord birth defects.||
7117|023|U|   Folic acid is a B-complex vitamin needed to form healthy||
7117|024|U|cells, especially red blood cells.||
7117|025|B|||
7117|026|H|HOW TO USE:  This medication is given by injection into a muscle||
7117|027|H|or vein or under the skin as directed by your doctor. The dosage||
7117|028|H|is based on your age, medical condition, and response to||
7117|029|H|treatment.||
7117|030|H|   If you are giving this medication to yourself at home, learn||
7117|031|H|all preparation and usage instructions from your health care||
7117|032|H|professional. Before using, check this product for particles or||
7117|033|H|discoloration. If either is present, do not use the liquid. Learn||
7117|034|H|how to store and discard medical supplies safely.||
7117|035|B|||
7117|036|S|SIDE EFFECTS:  Folic acid usually has very few side effects. If||
7117|037|S|you have any unusual effects from taking this medicine, tell your||
7117|038|S|doctor or pharmacist promptly.||
7117|039|S|   Remember that this medication has been prescribed because your||
7117|040|S|doctor has judged that the benefit to you is greater than the||
7117|041|S|risk of side effects. Many people using this medication do not||
7117|042|S|have serious side effects.||
7117|043|S|   A very serious allergic reaction to this drug is rare.||
7117|044|S|However, get medical help right away if you notice any symptoms||
7117|045|S|of a serious allergic reaction, including: rash, itching/swelling||
7117|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7117|047|S|breathing.||
7117|048|S|   This is not a complete list of possible side effects. If you||
7117|049|S|notice other effects not listed above, contact your doctor or||
7117|050|S|pharmacist.||
7117|051|S|   In the US -||
7117|052|S|   Call your doctor for medical advice about side effects. You||
7117|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7117|054|S|www.fda.gov/medwatch.||
7117|055|S|   In Canada - Call your doctor for medical advice about side||
7117|056|S|effects. You may report side effects to Health Canada at||
7117|057|S|1-866-234-2345.||
7117|058|B|||
7117|059|P|PRECAUTIONS:  Before using folic acid, tell your doctor or||
7117|060|P|pharmacist if you are allergic to it; or if you have any other||
7117|061|P|allergies. This product may contain inactive ingredients, which||
7117|062|P|can cause allergic reactions or other problems. Talk to your||
7117|063|P|pharmacist for more details.||
7117|064|P|   Before using this medication, tell your doctor or pharmacist||
7117|065|P|your medical history, especially of: kidney disease, vitamin B12||
7117|066|P|deficiency (pernicious anemia).||
7117|067|P|   This product may contain aluminum, which can rarely build up||
7117|068|P|to dangerous levels in the body. The risk may be increased if||
7117|069|P|this product is used for an extended time, especially in people||
7117|070|P|with kidney disease. Tell your doctor right away if you notice||
7117|071|P|any symptoms of too much aluminum in the body such as muscle||
7117|072|P|weakness, bone pain, or mental changes.||
7117|073|P|   Before having surgery, tell your doctor or dentist about all||
7117|074|P|the products you use (including prescription drugs,||
7117|075|P|nonprescription drugs, and herbal products).||
7117|076|P|   Folic acid is safe to take during pregnancy when used as||
7117|077|P|directed. Certain spinal cord birth defects may be prevented by||
7117|078|P|maintaining adequate amounts of folic acid during pregnancy.||
7117|079|P|Consult your doctor for more details.||
7117|080|P|   This medication passes into breast milk, but is unlikely to||
7117|081|P|harm a nursing infant. Consult your doctor before breastfeeding.||
7117|082|B|||
7117|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7117|084|I|medications work or increase your risk for serious side effects.||
7117|085|I|This document does not contain all possible drug interactions.||
7117|086|I|Keep a list of all the products you use (including||
7117|087|I|prescription/nonprescription drugs and herbal products) and share||
7117|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
7117|089|I|the dosage of any medicines without your doctor's approval.||
7117|090|I|   Folic acid may interfere with certain lab tests (such as||
7117|091|I|certain tests for vitamin B12 deficiency), possibly causing false||
7117|092|I|test results. Make sure lab personnel and all your doctors know||
7117|093|I|you use this drug.||
7117|094|B|||
7117|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7117|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7117|097|O|poison control center right away. US residents can call||
7117|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7117|099|B|||
7117|100|N|NOTES:  Do not share this medication with others.||
7117|101|N|   Lab and/or medical tests (such as complete blood count) may be||
7117|102|N|done while you are using this medication. Keep all medical and||
7117|103|N|lab appointments. Consult your doctor for more details.||
7117|104|N|   Folic acid is naturally found in leafy greens, beans, organ||
7117|105|N|meats (liver, kidney), and citrus fruits. You will also find it||
7117|106|N|in enriched bread, pasta and cereal. Consult your doctor or||
7117|107|N|dietician for a diet plan rich in folic acid.||
7117|108|B|||
7117|109|D|MISSED DOSE:  It is important to get each dose of this medication||
7117|110|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7117|111|D|right away for a new dosing schedule. Do not double the dose to||
7117|112|D|catch up.||
7117|113|B|||
7117|114|R|STORAGE:  Store at room temperature away from light. Keep all||
7117|115|R|medications away from children and pets.||
7117|116|R|   Do not flush medications down the toilet or pour them into a||
7117|117|R|drain unless instructed to do so. Properly discard this product||
7117|118|R|when it is expired or no longer needed. Consult your pharmacist||
7117|119|R|or local waste disposal company.||
7117|120|B|||
7117|121|A|Information last revised October 2025.||
7117|122|A|Copyright(c) 2025 First Databank, Inc.||
7117|123|B|||
7118|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7118|002|Z|does NOT have all possible information about this product. This||
7118|003|Z|information does not assure that this product is safe, effective,||
7118|004|Z|or appropriate for you. This information is not individual||
7118|005|Z|medical advice and does not substitute for the advice of your||
7118|006|Z|health care professional. Always ask your health care||
7118|007|Z|professional for complete information about this product and your||
7118|008|Z|specific health needs.||
7118|009|B|||
7118|010|T|GUAIFENESIN/CODEINE - ORAL||
7118|011|F|(gweye-FEN-eh-sin/KOE-deen)||
7118|012|B|||
7118|013|C|COMMON BRAND NAME(S): Cheracol, Ninjacof-XG, Robitussin A-C||
7118|014|B|||
7118|015|W|WARNING:  This medication has a risk for abuse and addiction,||
7118|016|W|which can lead to overdose and death. This medication may also||
7118|017|W|cause severe, possibly fatal, breathing problems. To lower your||
7118|018|W|risk, your doctor should have you take the smallest dose that||
7118|019|W|works, and take it for the shortest possible time. See also How||
7118|020|W|to Use section for more information about addiction.||
7118|021|W|   The risk for severe breathing problems is higher when you||
7118|022|W|start this medication, or if you take the wrong dose or take more||
7118|023|W|of this medication than prescribed. Taking this medication with||
7118|024|W|alcohol or other drugs that can cause drowsiness or breathing||
7118|025|W|problems may cause very serious side effects, including death.||
7118|026|W|Also, other medications can affect the removal of this product||
7118|027|W|from your body, which may affect how it works. Be sure you know||
7118|028|W|how to take this product and what other drugs you should avoid||
7118|029|W|taking with it. See also Drug Interactions section. Get medical||
7118|030|W|help right away if any of these very serious side effects occur:||
7118|031|W|slow/shallow breathing, unusual lightheadedness, severe||
7118|032|W|drowsiness/dizziness, difficulty waking up.||
7118|033|W|   Keep this medicine in a safe place to prevent theft, misuse,||
7118|034|W|or abuse. If someone accidentally swallows this drug, get medical||
7118|035|W|help right away.||
7118|036|W|   Before using this medication, women of childbearing age should||
7118|037|W|talk with their doctor(s) about the risks and benefits. Tell your||
7118|038|W|doctor if you are pregnant or think you may be pregnant. During||
7118|039|W|pregnancy, this medication is not recommended. It may slightly||
7118|040|W|increase the risk of birth defects if used during the first two||
7118|041|W|months of pregnancy. Also, using it for a long time or in high||
7118|042|W|doses near the expected delivery date may harm the unborn baby.||
7118|043|W|To lessen the risk, take the smallest effective dose for the||
7118|044|W|shortest possible time. Babies born to mothers who use this drug||
7118|045|W|for a long time may develop severe (possibly fatal) withdrawal||
7118|046|W|symptoms. Tell the doctor right away if you notice any symptoms||
7118|047|W|in your newborn baby such as crying that doesn't stop,||
7118|048|W|slow/shallow breathing, irritability, shaking, vomiting,||
7118|049|W|diarrhea, poor feeding, or difficulty gaining weight.||
7118|050|B|||
7118|051|U|USES:  This combination medication is used to temporarily treat||
7118|052|U|coughing and chest congestion symptoms caused by the common cold,||
7118|053|U|flu, or other breathing illnesses (such as sinusitis,||
7118|054|U|bronchitis). Guaifenesin is an expectorant that helps thin and||
7118|055|U|loosen mucus in the lungs, making it easier to cough up the||
7118|056|U|mucus. Codeine is an opioid cough suppressant (antitussive) that||
7118|057|U|affects a certain part of the brain, reducing the urge to cough.||
7118|058|U|   This medication is not usually used for ongoing coughs from||
7118|059|U|smoking, asthma, other long-term breathing problems (such as||
7118|060|U|emphysema), or for coughs with a lot of mucus, unless directed by||
7118|061|U|your doctor.||
7118|062|U|   Opioid cough suppressants should not be used by children||
7118|063|U|younger than 18 years. Children are at higher risk for serious||
7118|064|U|(even fatal) side effects, especially breathing problems. Talk||
7118|065|U|with the doctor about the risks and benefits of this medication.||
7118|066|U|   Cough-and-cold products do not cure colds. Cough due to a||
7118|067|U|common cold often does not need to be treated with medicine. Ask||
7118|068|U|your doctor or pharmacist about other ways to relieve cough and||
7118|069|U|cold symptoms, such as drinking enough fluids, using a||
7118|070|U|humidifier, or saline nose drops/spray.||
7118|071|B|||
7118|072|H|HOW TO USE:  Take this medication by mouth with or without food||
7118|073|H|as directed by your doctor, usually every 4 to 6 hours as needed||
7118|074|H|with a full glass of water (8 ounces or 240 milliliters). This||
7118|075|H|medication can be taken with food if stomach upset occurs. Drink||
7118|076|H|plenty of fluids while you are using this medication unless||
7118|077|H|otherwise directed by your doctor. The fluid will help loosen the||
7118|078|H|mucus in your lungs.||
7118|079|H|   If you are using the liquid form of this medication, carefully||
7118|080|H|measure the dose using a special measuring device/spoon. Do not||
7118|081|H|use a household spoon because you may not get the correct dose.||
7118|082|H|   Some liquids need to be shaken before pouring each dose. Check||
7118|083|H|your bottle or ask your pharmacist if your product needs to be||
7118|084|H|shaken.||
7118|085|H|   Do not increase your dose or use this product more often or||
7118|086|H|for longer than prescribed. Your condition will not improve any||
7118|087|H|faster, and your risk of side effects will increase.||
7118|088|H|   If you suddenly stop using this medication, you may have||
7118|089|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
7118|090|H|nose, nausea, sweating, muscle aches). To help prevent||
7118|091|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
7118|092|H|more likely if you have used this medication for a long time||
7118|093|H|(more than a few weeks) or in high doses. Tell your doctor or||
7118|094|H|pharmacist right away if you have withdrawal.||
7118|095|H|   Though it helps many people, this product may sometimes cause||
7118|096|H|addiction. This risk may be higher if you have a mental/mood||
7118|097|H|disorder or a substance use disorder (such as overuse of or||
7118|098|H|addiction to drugs/alcohol). Take this product exactly as||
7118|099|H|prescribed to lower the risk of addiction. Ask your doctor or||
7118|100|H|pharmacist for more details.||
7118|101|H|   When used for an extended time, this medication may not work||
7118|102|H|as well and may require different dosing. Talk with your doctor||
7118|103|H|if this medication stops working well.||
7118|104|H|   Tell your doctor if your cough does not get better in 5 days.||
7118|105|H|Also, tell your doctor if your condition gets worse, or if you||
7118|106|H|have a headache that doesn't go away, fever, or rash. These may||
7118|107|H|be symptoms of a serious medical problem and should be checked by||
7118|108|H|a doctor.||
7118|109|B|||
7118|110|S|SIDE EFFECTS:  See also Warning section.||
7118|111|S|   Drowsiness, dizziness, lightheadedness, facial flushing,||
7118|112|S|nausea, vomiting, or constipation may occur. If any of these||
7118|113|S|effects last or get worse, tell your doctor or pharmacist||
7118|114|S|promptly.||
7118|115|S|   To reduce the risk of dizziness and lightheadedness, get up||
7118|116|S|slowly when rising from a sitting or lying position.||
7118|117|S|   Remember that this medication has been prescribed because your||
7118|118|S|doctor has judged that the benefit to you is greater than the||
7118|119|S|risk of side effects. Many people using this medication do not||
7118|120|S|have serious side effects.||
7118|121|S|   Tell your doctor right away if you have any serious side||
7118|122|S|effects, including: interrupted breathing during sleep (sleep||
7118|123|S|apnea), mental/mood changes (such as hallucinations),||
7118|124|S|fast/irregular heartbeat, trouble urinating, trouble swallowing.||
7118|125|S|   Get medical help right away if you have any very serious side||
7118|126|S|effects, including: seizure.||
7118|127|S|   Codeine is changed into a strong opioid drug (morphine) in||
7118|128|S|your body. In some people, this change happens faster and more||
7118|129|S|completely than usual, which increases the risk of very serious||
7118|130|S|side effects. Get medical help right away if you notice any of||
7118|131|S|the following: slow/shallow breathing, severe||
7118|132|S|drowsiness/difficulty waking up, confusion.||
7118|133|S|   A very serious allergic reaction to this drug is rare.||
7118|134|S|However, get medical help right away if you notice any symptoms||
7118|135|S|of a serious allergic reaction, including: rash, itching/swelling||
7118|136|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7118|137|S|breathing.||
7118|138|S|   This is not a complete list of possible side effects. If you||
7118|139|S|notice other side effects not listed above, contact your doctor||
7118|140|S|or pharmacist.||
7118|141|S|   In the US -||
7118|142|S|   Call your doctor for medical advice about side effects. You||
7118|143|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7118|144|S|www.fda.gov/medwatch.||
7118|145|S|   In Canada - Call your doctor for medical advice about side||
7118|146|S|effects. You may report side effects to Health Canada at||
7118|147|S|1-866-234-2345.||
7118|148|B|||
7118|149|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
7118|150|P|pharmacist if you are allergic to any of its ingredients; or to||
7118|151|P|opioid pain relievers (such as morphine); or if you have any||
7118|152|P|other allergies. This product may contain inactive ingredients,||
7118|153|P|which can cause allergic reactions or other problems. Talk to||
7118|154|P|your pharmacist for more details.||
7118|155|P|   Before using this medication, tell your doctor or pharmacist||
7118|156|P|your medical history, especially of: abdominal problems (such as||
7118|157|P|chronic constipation, ileus, gallbladder disease, pancreatitis),||
7118|158|P|adrenal gland problem (such as Addison's disease), brain||
7118|159|P|disorders (such as seizures, head injury, tumor, increased||
7118|160|P|intracranial pressure), breathing problems (such as asthma,||
7118|161|P|emphysema, sleep apnea), heart problems (such as irregular||
7118|162|P|heartbeat), kidney disease, liver disease, mental/mood disorders||
7118|163|P|(such as depression, psychosis), obesity, a certain spinal||
7118|164|P|problem (kyphoscoliosis), underactive thyroid (hypothyroidism),||
7118|165|P|trouble urinating (such as due to enlarged prostate or urethral||
7118|166|P|stricture), personal or family history of a substance use||
7118|167|P|disorder (such as overuse of or addiction to drugs/alcohol).||
7118|168|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7118|169|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7118|170|P|machinery, or do anything that needs alertness until you can do||
7118|171|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
7118|172|P|are using marijuana (cannabis).||
7118|173|P|   Liquid forms of this medication may contain sugar, alcohol, or||
7118|174|P|aspartame. Caution is advised if you have diabetes, alcohol||
7118|175|P|dependence, liver disease, phenylketonuria (PKU), or any other||
7118|176|P|condition that requires you to monitor/avoid these substances in||
7118|177|P|your diet. Consult your doctor or pharmacist about using this||
7118|178|P|medication safely.||
7118|179|P|   Older adults may be more sensitive to the side effects of this||
7118|180|P|drug, especially confusion, dizziness, drowsiness, and||
7118|181|P|slow/shallow breathing.||
7118|182|P|   Tell your doctor if you are pregnant or think you may be||
7118|183|P|pregnant. During pregnancy, this product is not recommended. It||
7118|184|P|may harm an unborn baby. Talk to your doctor about the risks and||
7118|185|P|benefits of this medication. See also Warning section.||
7118|186|P|   This product passes into breast milk and may have undesirable||
7118|187|P|effects on a nursing infant (such as unusual sleepiness,||
7118|188|P|difficulty feeding, trouble breathing, or unusual limpness).||
7118|189|P|Consult your doctor before breastfeeding.||
7118|190|B|||
7118|191|I|DRUG INTERACTIONS:  See also Warning section.||
7118|192|I|   Drug interactions may change how your medications work or||
7118|193|I|increase your risk for serious side effects. This document does||
7118|194|I|not contain all possible drug interactions. Keep a list of all||
7118|195|I|the products you use (including prescription/nonprescription||
7118|196|I|drugs and herbal products) and share it with your doctor and||
7118|197|I|pharmacist. Do not start, stop, or change the dosage of any||
7118|198|I|medicines without your doctor's approval.||
7118|199|I|   Some products that may interact with this drug include:||
7118|200|I|cimetidine, naltrexone, samidorphan.||
7118|201|I|   Guaifenesin is available in both prescription and||
7118|202|I|nonprescription products. Check the labels on all your||
7118|203|I|medications carefully to make sure you are not taking more than||
7118|204|I|one product that contains guaifenesin.||
7118|205|I|   The risk of serious side effects (such as slow/shallow||
7118|206|I|breathing, severe drowsiness/dizziness) may be increased if this||
7118|207|I|medication is taken with other products that may also cause||
7118|208|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
7118|209|I|if you are taking other products such as other opioid pain or||
7118|210|I|cough relievers (such as morphine, hydrocodone), alcohol,||
7118|211|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
7118|212|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
7118|213|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
7118|214|I|cetirizine, diphenhydramine).||
7118|215|I|   Check the labels on all your medicines (such as allergy or||
7118|216|I|cough-and-cold products) because they may contain ingredients||
7118|217|I|that cause drowsiness. Ask your pharmacist about using those||
7118|218|I|products safely.||
7118|219|I|   Other medications can affect the removal of||
7118|220|I|guaifenesin/codeine from your body, which may affect how||
7118|221|I|guaifenesin/codeine works. Examples include azole antifungals||
7118|222|I|(such as ketoconazole), bupropion, fluoxetine, macrolide||
7118|223|I|antibiotics (such as erythromycin), paroxetine, quinidine,||
7118|224|I|rifamycins (such as rifabutin, rifampin), ritonavir, certain||
7118|225|I|drugs used to treat seizures (such as carbamazepine, phenytoin),||
7118|226|I|among others.||
7118|227|I|   This medication may interfere with certain lab tests (such as||
7118|228|I|urine 5-HIAA levels, urine VMA levels, amylase/lipase levels),||
7118|229|I|possibly causing false test results. Make sure lab personnel and||
7118|230|I|all your doctors know you use this drug.||
7118|231|B|||
7118|232|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7118|233|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7118|234|O|poison control center right away. US residents can call||
7118|235|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7118|236|O|Symptoms of overdose may include: fast/slow/irregular heartbeat,||
7118|237|O|slow/shallow breathing, cold/clammy skin, coma.||
7118|238|B|||
7118|239|N|NOTES:  Do not share this medication with others. Sharing it is||
7118|240|N|against the law.||
7118|241|N|   This medication has been prescribed for your current condition||
7118|242|N|only. Do not use it later for another condition unless told to do||
7118|243|N|so by your doctor. A different medication may be necessary in||
7118|244|N|that case.||
7118|245|B|||
7118|246|D|MISSED DOSE:  If you are prescribed this medication on a regular||
7118|247|D|schedule and miss a dose, take it as soon as you remember. If it||
7118|248|D|is near the time of the next dose, skip the missed dose. Take||
7118|249|D|your next dose at the regular time. Do not double the dose to||
7118|250|D|catch up.||
7118|251|B|||
7118|252|R|STORAGE:  Store at room temperature away from light and moisture.||
7118|253|R|Do not store in the bathroom. Do not freeze liquid forms of this||
7118|254|R|medication. Keep all medications away from children and pets.||
7118|255|R|   Do not flush medications down the toilet or pour them into a||
7118|256|R|drain unless instructed to do so. Properly discard this product||
7118|257|R|when it is expired or no longer needed. Consult your pharmacist||
7118|258|R|or local waste disposal company.||
7118|259|B|||
7118|260|A|Information last revised August 2025.||
7118|261|A|Copyright(c) 2025 First Databank, Inc.||
7118|262|B|||
7119|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7119|002|Z|does NOT have all possible information about this product. This||
7119|003|Z|information does not assure that this product is safe, effective,||
7119|004|Z|or appropriate for you. This information is not individual||
7119|005|Z|medical advice and does not substitute for the advice of your||
7119|006|Z|health care professional. Always ask your health care||
7119|007|Z|professional for complete information about this product and your||
7119|008|Z|specific health needs.||
7119|009|B|||
7119|010|T|MEBENDAZOLE CHEWABLE TABLET - ORAL||
7119|011|F|(meh-BEN-duh-zole)||
7119|012|B|||
7119|013|C|COMMON BRAND NAME(S): Emverm, Vermox||
7119|014|B|||
7119|015|U|USES:  Mebendazole is used to treat intestinal worm infections||
7119|016|U|such as pinworm, roundworm, and hookworm.||
7119|017|B|||
7119|018|V|OTHER USES:  This section contains uses of this drug that are not||
7119|019|V|listed in the approved professional labeling for the drug but||
7119|020|V|that may be prescribed by your health care professional. Use this||
7119|021|V|drug for a condition that is listed in this section only if it||
7119|022|V|has been so prescribed by your health care professional.||
7119|023|V|   This drug may also be used for worm infections elsewhere in||
7119|024|V|the body (such as trichinosis). In these cases, it is usually||
7119|025|V|taken more often and for a longer time.||
7119|026|B|||
7119|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7119|028|H|from your pharmacist before you start taking mebendazole and each||
7119|029|H|time you get a refill. If you have any questions, ask your doctor||
7119|030|H|or pharmacist.||
7119|031|H|   Take this medication by mouth with or without food as directed||
7119|032|H|by your doctor. It may be chewed, swallowed whole, or crushed and||
7119|033|H|mixed with food. The dosage is based on your medical condition||
7119|034|H|and response to treatment.||
7119|035|H|   For treatment of pinworm infections, the medication is usually||
7119|036|H|given as a single dose. If necessary, a second treatment may be||
7119|037|H|given in a few weeks. For other types of common worm infections||
7119|038|H|(such as roundworm, hookworm), take mebendazole by mouth as||
7119|039|H|directed by your doctor, usually twice a day (in the morning and||
7119|040|H|in the evening) for 3 days. If necessary, a second treatment may||
7119|041|H|be given in a few weeks. For other types of infections, follow||
7119|042|H|your doctor's directions. Your doctor may order you to take this||
7119|043|H|medication more often than twice a day and for longer than 3||
7119|044|H|days.||
7119|045|H|   It is very important to keep taking this medication exactly as||
7119|046|H|prescribed by your doctor. Do not skip any doses. Keep taking||
7119|047|H|this medication until the full prescribed amount is finished,||
7119|048|H|even if symptoms disappear. Stopping the medication too early may||
7119|049|H|result in a return of the infection.||
7119|050|H|   Tell your doctor if your condition lasts or gets worse.||
7119|051|B|||
7119|052|S|SIDE EFFECTS:  Stomach/abdominal pain, vomiting, diarrhea,||
7119|053|S|headache, dizziness, or drowsiness may occur. If any of these||
7119|054|S|effects last or get worse, tell your doctor or pharmacist||
7119|055|S|promptly.||
7119|056|S|   Remember that this medication has been prescribed because your||
7119|057|S|doctor has judged that the benefit to you is greater than the||
7119|058|S|risk of side effects. Many people using this medication do not||
7119|059|S|have serious side effects.||
7119|060|S|   Tell your doctor right away if you have any serious side||
7119|061|S|effects, including: severe abdominal pain, easy||
7119|062|S|bleeding/bruising, signs of infection (such as sore throat that||
7119|063|S|doesn't go away, fever, chills), unusual tiredness, seizures,||
7119|064|S|weakness, dark or pinkish urine, yellowing eyes/skin.||
7119|065|S|   A very serious allergic reaction to this drug is rare.||
7119|066|S|However, get medical help right away if you notice any symptoms||
7119|067|S|of a serious allergic reaction, including: rash, itching/swelling||
7119|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7119|069|S|breathing.||
7119|070|S|   This is not a complete list of possible side effects. If you||
7119|071|S|notice other effects not listed above, contact your doctor or||
7119|072|S|pharmacist.||
7119|073|S|   In the US -||
7119|074|S|   Call your doctor for medical advice about side effects. You||
7119|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7119|076|S|www.fda.gov/medwatch.||
7119|077|S|   In Canada - Call your doctor for medical advice about side||
7119|078|S|effects. You may report side effects to Health Canada at||
7119|079|S|1-866-234-2345.||
7119|080|B|||
7119|081|P|PRECAUTIONS:  Before taking mebendazole, tell your doctor or||
7119|082|P|pharmacist if you are allergic to it; or if you have any other||
7119|083|P|allergies. This product may contain inactive ingredients, which||
7119|084|P|can cause allergic reactions or other problems. Talk to your||
7119|085|P|pharmacist for more details.||
7119|086|P|   Tell your doctor your medical history, especially of: low||
7119|087|P|blood count (anemia), liver disease, intestinal problems (such as||
7119|088|P|Crohn's disease, ulcerative colitis).||
7119|089|P|   Before having surgery, tell your doctor or dentist about all||
7119|090|P|the products you use (including prescription drugs,||
7119|091|P|nonprescription drugs, and herbal products).||
7119|092|P|   During pregnancy, this medication should be used only when||
7119|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
7119|094|P|   This drug passes into breast milk. Consult your doctor before||
7119|095|P|breastfeeding.||
7119|096|B|||
7119|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7119|098|I|medications work or increase your risk for serious side effects.||
7119|099|I|This document does not contain all possible drug interactions.||
7119|100|I|Keep a list of all the products you use (including||
7119|101|I|prescription/nonprescription drugs and herbal products) and share||
7119|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
7119|103|I|the dosage of any medicines without your doctor's approval.||
7119|104|I|   A product that may interact with this drug is: metronidazole.||
7119|105|B|||
7119|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7119|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7119|108|O|poison control center right away. US residents can call||
7119|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7119|110|B|||
7119|111|N|NOTES:  Do not share this medication with others.||
7119|112|N|   If you are taking this medication for a long time, lab and/or||
7119|113|N|medical tests (such as complete blood count, liver/kidney||
7119|114|N|function) may be done while you are taking this medication. Keep||
7119|115|N|all medical and lab appointments. Consult your doctor for more||
7119|116|N|details.||
7119|117|N|   Pinworm infections can easily spread to others. All family||
7119|118|N|members in close contact with the patient should be treated to||
7119|119|N|decrease the chance of spreading the infection.||
7119|120|N|   Practice strict hygiene to prevent another infection. Wash||
7119|121|N|hands often, especially after using the bathroom. Disinfect||
7119|122|N|toilets daily. Change and launder undergarments, towels, and||
7119|123|N|bedclothes daily.||
7119|124|B|||
7119|125|D|MISSED DOSE:  If you are taking more than one dose and miss a||
7119|126|D|dose, take it as soon as you remember. If it is near the time of||
7119|127|D|the next dose, skip the missed dose. Take your next dose at the||
7119|128|D|regular time. Do not double the dose to catch up.||
7119|129|B|||
7119|130|R|STORAGE:  Store at room temperature away from light and moisture.||
7119|131|R|Do not store in the bathroom. Keep all medications away from||
7119|132|R|children and pets.||
7119|133|R|   Do not flush medications down the toilet or pour them into a||
7119|134|R|drain unless instructed to do so. Properly discard this product||
7119|135|R|when it is expired or no longer needed. Consult your pharmacist||
7119|136|R|or local waste disposal company.||
7119|137|B|||
7119|138|A|Information last revised April 2025.||
7119|139|A|Copyright(c) 2025 First Databank, Inc.||
7119|140|B|||
7120|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7120|002|Z|does NOT have all possible information about this product. This||
7120|003|Z|information does not assure that this product is safe, effective,||
7120|004|Z|or appropriate for you. This information is not individual||
7120|005|Z|medical advice and does not substitute for the advice of your||
7120|006|Z|health care professional. Always ask your health care||
7120|007|Z|professional for complete information about this product and your||
7120|008|Z|specific health needs.||
7120|009|B|||
7120|010|T|MEDROXYPROGESTERONE ACETATE (CONTRACEPTIVE) - INTRAMUSCULAR||
7120|011|F|(med-ROX-ee-proe-JES-ter-one AS-e-tate)||
7120|012|B|||
7120|013|C|COMMON BRAND NAME(S): Depo-Provera||
7120|014|B|||
7120|015|W|WARNING:  This medication may cause serious bone loss which may||
7120|016|W|not return to normal after you stop using it. The risk of bone||
7120|017|W|loss increases with longer use of this medication and smoking.||
7120|018|W|This medication should not be used for longer than 2 years unless||
7120|019|W|other birth control methods will not work for you. An important||
7120|020|W|time when your bones continue to build up is during your teenage||
7120|021|W|and young adult years. Use of this medication may increase the||
7120|022|W|risk of weak/brittle bones (osteoporosis), which can lead to||
7120|023|W|broken bones when you are older. Talk with your doctor about the||
7120|024|W|risks and benefits of this medication and other birth control||
7120|025|W|choices.||
7120|026|B|||
7120|027|U|USES:  This medication is used to prevent pregnancy.||
7120|028|U|Medroxyprogesterone is like a natural hormone made by the body.||
7120|029|U|   This medication does not protect against sexually transmitted||
7120|030|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
7120|031|U|an effective barrier method (latex or polyurethane condom/dental||
7120|032|U|dams) during sexual activity will help to decrease your risk of||
7120|033|U|infection.||
7120|034|B|||
7120|035|V|OTHER USES:  This section contains uses of this drug that are not||
7120|036|V|listed in the approved professional labeling for the drug but||
7120|037|V|that may be prescribed by your health care professional. Use this||
7120|038|V|drug for a condition that is listed in this section only if it||
7120|039|V|has been so prescribed by your health care professional.||
7120|040|V|   This medication may also be used for endometriosis.||
7120|041|B|||
7120|042|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
7120|043|H|your pharmacist before you start using this product and each time||
7120|044|H|you get a refill. If you have any questions, ask your doctor or||
7120|045|H|pharmacist.||
7120|046|H|   This medication is given by injection into a muscle as||
7120|047|H|directed by your doctor, usually once every 3 months. The||
7120|048|H|injection is given in the upper arm or buttock. To make sure you||
7120|049|H|are not pregnant, the first injection is usually given during the||
7120|050|H|first 5 days of your menstrual period. If you have just given||
7120|051|H|birth or had a pregnancy loss or abortion after the first 3||
7120|052|H|months of pregnancy, talk with your doctor about the best time to||
7120|053|H|start using this form of birth control.||
7120|054|H|   Use this medication regularly to get the most benefit from it.||
7120|055|H|To help you remember, mark your calendar with a reminder. If more||
7120|056|H|than 13 weeks pass between injections, you could become pregnant.||
7120|057|H|Use a form of non-hormonal birth control (such as condoms,||
7120|058|H|diaphragm, spermicide) to prevent pregnancy until you can get the||
7120|059|H|next injection. Your doctor may direct you to first have a||
7120|060|H|pregnancy test before your next injection.||
7120|061|B|||
7120|062|S|SIDE EFFECTS:  Nausea, bloating, headache, changes in appetite,||
7120|063|S|weight gain, tiredness, swelling, acne, hot flashes, breast||
7120|064|S|tenderness, or irritation/pain at the injection site may occur.||
7120|065|S|Vaginal bleeding between periods (spotting) or missed/irregular||
7120|066|S|periods may occur, especially during the first few months of use.||
7120|067|S|If any of these effects last or get worse, tell your doctor or||
7120|068|S|pharmacist promptly. Your periods may stop completely after you||
7120|069|S|have been receiving this medication for about a year. If this||
7120|070|S|occurs, your periods will normally return after you stop using||
7120|071|S|this medication. If you miss a period and have missed an||
7120|072|S|injection, or if more than 13 weeks pass between injections and||
7120|073|S|you think you might be pregnant, contact your doctor for a||
7120|074|S|pregnancy test.||
7120|075|S|   Remember that this medication has been prescribed because your||
7120|076|S|doctor has judged that the benefit to you is greater than the||
7120|077|S|risk of side effects. Many people using this medication do not||
7120|078|S|have serious side effects.||
7120|079|S|   Tell your doctor right away if you have any serious side||
7120|080|S|effects, including: nausea/vomiting that doesn't stop,||
7120|081|S|mental/mood changes (such as new/worsening depression), changes||
7120|082|S|in sexual interest/ability, swelling of the ankles/feet, bone||
7120|083|S|pain, unusual changes in vaginal bleeding (such as continuous||
7120|084|S|spotting, sudden heavy bleeding), severe stomach/abdominal/pelvic||
7120|085|S|pain, unusual weakness/tiredness, dark urine, yellowing||
7120|086|S|eyes/skin, seizure.||
7120|087|S|   This medication may increase your risk of breast cancer. Tell||
7120|088|S|your doctor right away if you have symptoms such as a lump in the||
7120|089|S|breast or nipple discharge. Ask your doctor for more details.||
7120|090|S|   Rarely, people using this medication have had very serious||
7120|091|S|(possibly fatal) problems from blood clots (such as heart attack,||
7120|092|S|stroke, blood clots in the lungs, legs, or eyes). Get medical||
7120|093|S|help right away if you have: shortness of breath/rapid breathing,||
7120|094|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
7120|095|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
7120|096|S|sudden/severe headaches, trouble speaking, weakness on one side||
7120|097|S|of the body, sudden vision changes.||
7120|098|S|   A very serious allergic reaction to this drug is rare.||
7120|099|S|However, get medical help right away if you notice any symptoms||
7120|100|S|of a serious allergic reaction, including: rash, itching/swelling||
7120|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7120|102|S|breathing.||
7120|103|S|   This is not a complete list of possible side effects. If you||
7120|104|S|notice other effects not listed above, contact your doctor or||
7120|105|S|pharmacist.||
7120|106|S|   In the US -||
7120|107|S|   Call your doctor for medical advice about side effects. You||
7120|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7120|109|S|www.fda.gov/medwatch.||
7120|110|S|   In Canada - Call your doctor for medical advice about side||
7120|111|S|effects. You may report side effects to Health Canada at||
7120|112|S|1-866-234-2345.||
7120|113|B|||
7120|114|P|PRECAUTIONS:  Before using medroxyprogesterone, tell your doctor||
7120|115|P|or pharmacist if you are allergic to it; or if you have any other||
7120|116|P|allergies. This product may contain inactive ingredients, which||
7120|117|P|can cause allergic reactions or other problems. Talk to your||
7120|118|P|pharmacist for more details.||
7120|119|P|   Before using this medication, tell your doctor or pharmacist||
7120|120|P|your medical history, especially of: blood clots (for example, in||
7120|121|P|the legs, eyes, lungs), unexplained vaginal bleeding, asthma,||
7120|122|P|abnormal breast exam, personal or family history of cancer||
7120|123|P|(especially breast or cervical cancer), daily use of||
7120|124|P|alcohol/tobacco, depression, diabetes, eating disorder||
7120|125|P|(anorexia), heart problems (such as heart failure, irregular||
7120|126|P|heartbeat, previous heart attack), high blood pressure, kidney||
7120|127|P|disease, liver disease (including tumors), high cholesterol or||
7120|128|P|triglyceride (blood fat) levels, migraine, seizures, stroke or||
7120|129|P|"mini-stroke" (transient ischemic attack), personal/family||
7120|130|P|history of bone disease (such as osteoporosis).||
7120|131|P|   Before having surgery, tell your doctor or dentist about all||
7120|132|P|the products you use (including prescription drugs,||
7120|133|P|nonprescription drugs, and herbal products).||
7120|134|P|   It may take longer for you to become pregnant after you stop||
7120|135|P|using this medication. Consult your doctor.||
7120|136|P|   This medication should not be used during pregnancy. If you||
7120|137|P|become pregnant or think you may be pregnant, tell your doctor||
7120|138|P|right away.||
7120|139|P|   This drug passes into breast milk. Consult your doctor before||
7120|140|P|breastfeeding.||
7120|141|B|||
7120|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7120|143|I|medications work or increase your risk for serious side effects.||
7120|144|I|This document does not contain all possible drug interactions.||
7120|145|I|Keep a list of all the products you use (including||
7120|146|I|prescription/nonprescription drugs and herbal products) and share||
7120|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
7120|148|I|the dosage of any medicines without your doctor's approval.||
7120|149|I|   Some drugs may cause hormonal birth control to work less well||
7120|150|I|by decreasing the amount of birth control hormones in your body.||
7120|151|I|This effect can result in pregnancy. Examples include||
7120|152|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
7120|153|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
7120|154|I|seizures (such as barbiturates, carbamazepine, felbamate,||
7120|155|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
7120|156|I|nevirapine), among others.||
7120|157|I|   Tell your doctor when you start any new drug, and discuss if||
7120|158|I|you should use reliable backup birth control. Also tell your||
7120|159|I|doctor if you have any new spotting or breakthrough bleeding,||
7120|160|I|because these may be signs that your birth control is not working||
7120|161|I|well.||
7120|162|I|   This medication may interfere with certain lab tests (such as||
7120|163|I|certain hormone levels, blood tests for clotting factors,||
7120|164|I|thyroid/liver function tests), possibly causing false test||
7120|165|I|results. Make sure lab personnel and all your doctors know you||
7120|166|I|use this drug.||
7120|167|B|||
7120|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7120|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7120|170|O|poison control center right away. US residents can call||
7120|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7120|172|B|||
7120|173|N|NOTES:  Do not share this medication with others.||
7120|174|N|   Regular complete physical exams which include lab and/or||
7120|175|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
7120|176|N|Pap smear) should be done while you are using this medication.||
7120|177|N|Follow your doctor's instructions for examining your breasts, and||
7120|178|N|report any lumps right away. Keep all medical and lab||
7120|179|N|appointments. Consult your doctor for more details. Your doctor||
7120|180|N|may test your bone density while you are using this medication.||
7120|181|N|Be sure to get enough vitamin D and calcium in your diet. Ask||
7120|182|N|your doctor or pharmacist about calcium/vitamin D supplements to||
7120|183|N|help keep your bones healthy.||
7120|184|B|||
7120|185|D|MISSED DOSE:  It is important to get each dose of this medication||
7120|186|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7120|187|D|right away for a new dosing schedule.||
7120|188|B|||
7120|189|R|STORAGE:  Not applicable. This medication is given in a clinic or||
7120|190|R|doctor's office and will not be stored at home.||
7120|191|B|||
7120|192|A|Information last revised October 2025.||
7120|193|A|Copyright(c) 2025 First Databank, Inc.||
7120|194|B|||
7125|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7125|002|Z|does NOT have all possible information about this product. This||
7125|003|Z|information does not assure that this product is safe, effective,||
7125|004|Z|or appropriate for you. This information is not individual||
7125|005|Z|medical advice and does not substitute for the advice of your||
7125|006|Z|health care professional. Always ask your health care||
7125|007|Z|professional for complete information about this product and your||
7125|008|Z|specific health needs.||
7125|009|B|||
7125|010|T|COMBINATION ANTIBIOTIC - TOPICAL||
7125|011|B|||
7125|012|U|USES:  This combination product is used to treat minor wounds||
7125|013|U|(such as cuts, scrapes, burns) and to help prevent or treat mild||
7125|014|U|skin infections. Minor skin infections and wounds usually heal||
7125|015|U|without treatment, but some minor skin wounds may heal faster||
7125|016|U|when an antibiotic is applied to the affected area. This product||
7125|017|U|contains antibiotics that work by slowing or stopping the growth||
7125|018|U|of bacteria.||
7125|019|B|||
7125|020|H|HOW TO USE:  This medication is for use on the skin only. Follow||
7125|021|H|all directions on the product package, or use as directed by your||
7125|022|H|doctor. Wash your hands before using. Avoid getting this product||
7125|023|H|in your eyes or inside the mouth. If this occurs, wipe off the||
7125|024|H|medication and rinse thoroughly with water. Do not use inside the||
7125|025|H|nose unless directed by your doctor.||
7125|026|H|   Clean and dry the affected area as directed. If you are using||
7125|027|H|the ointment or cream, apply a small amount of the medication in||
7125|028|H|a thin layer on the skin, usually 1 to 3 times daily or as||
7125|029|H|directed by your doctor. Rub in gently if your condition permits.||
7125|030|H|If you are using the powder, apply a light dusting of the powder||
7125|031|H|on the area. Cover with a bandage if directed to do so. Wash your||
7125|032|H|hands after use.||
7125|033|H|   Do not use large amounts of this medication, apply it more||
7125|034|H|often, or use it for a longer period than directed. Your||
7125|035|H|condition may not improve faster, and the risk for side effects||
7125|036|H|may be increased.||
7125|037|H|   Use this medication regularly in order to get the most benefit||
7125|038|H|from it. To help you remember, use it at the same times each day.||
7125|039|H|   Tell your doctor if your condition does not get better or if||
7125|040|H|it gets worse after 1 week. If you think you may have a serious||
7125|041|H|medical problem, get medical help right away.||
7125|042|B|||
7125|043|S|SIDE EFFECTS:  Burning, redness, or irritation of the skin may||
7125|044|S|occur. If any of these effects last or get worse, tell your||
7125|045|S|doctor or pharmacist promptly.||
7125|046|S|   If your doctor has prescribed this medication, remember that||
7125|047|S|your doctor has judged that the benefit to you is greater than||
7125|048|S|the risk of side effects. Many people using this medication do||
7125|049|S|not have serious side effects.||
7125|050|S|   Tell your doctor right away if you have any serious side||
7125|051|S|effects, including: balance/hearing problems, small red bumps on||
7125|052|S|the skin (folliculitis).||
7125|053|S|   Rarely, use of this medication for prolonged or repeated||
7125|054|S|periods may result in a fungal infection or a different bacterial||
7125|055|S|skin infection. Contact your doctor if you notice any new unusual||
7125|056|S|skin symptoms (such as scaling, swelling, hot skin) while using||
7125|057|S|this medication. A different medication may need to be used.||
7125|058|S|   A very serious allergic reaction to this drug is rare.||
7125|059|S|However, get medical help right away if you notice any symptoms||
7125|060|S|of a serious allergic reaction, including: rash, itching/swelling||
7125|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7125|062|S|breathing.||
7125|063|S|   This is not a complete list of possible side effects. If you||
7125|064|S|notice other effects not listed above, contact your doctor or||
7125|065|S|pharmacist.||
7125|066|S|   In the US -||
7125|067|S|   Call your doctor for medical advice about side effects. You||
7125|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7125|069|S|www.fda.gov/medwatch.||
7125|070|S|   In Canada - Call your doctor for medical advice about side||
7125|071|S|effects. You may report side effects to Health Canada at||
7125|072|S|1-866-234-2345.||
7125|073|B|||
7125|074|P|PRECAUTIONS:  Before using this product, tell your doctor or||
7125|075|P|pharmacist if you are allergic to any of its ingredients; or if||
7125|076|P|you have any other allergies. This product may contain inactive||
7125|077|P|ingredients, which can cause allergic reactions or other||
7125|078|P|problems. Talk to your pharmacist for more details.||
7125|079|P|   Before using this medication, tell your doctor or pharmacist||
7125|080|P|your medical history, especially of: other skin conditions||
7125|081|P|(including eczema, viral skin infections such as shingles,||
7125|082|P|chickenpox, cold sores).||
7125|083|P|   Before having surgery, tell your doctor or dentist about all||
7125|084|P|the products you use (including prescription drugs,||
7125|085|P|nonprescription drugs, and herbal products).||
7125|086|P|   During pregnancy, this medication should be used only when||
7125|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
7125|088|P|   It is unknown if this drug passes into breast milk. Consult||
7125|089|P|your doctor before breastfeeding.||
7125|090|B|||
7125|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7125|092|I|medications work or increase your risk for serious side effects.||
7125|093|I|This document does not contain all possible drug interactions.||
7125|094|I|Keep a list of all the products you use (including||
7125|095|I|prescription/nonprescription drugs and herbal products) and share||
7125|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
7125|097|I|the dosage of any medicines without your doctor's approval.||
7125|098|B|||
7125|099|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7125|100|O|has overdosed and has serious symptoms such as passing out or||
7125|101|O|trouble breathing, call 911. Otherwise, call a poison control||
7125|102|O|center right away. US residents can call 1-800-222-1222. Canada||
7125|103|O|residents can call 1-844-764-7669.||
7125|104|B|||
7125|105|N|NOTES:  If your doctor has prescribed this product for you, do||
7125|106|N|not share it with others.||
7125|107|N|   If your doctor has directed you to use this product, use it||
7125|108|N|for your current condition only. Do not use it later for another||
7125|109|N|infection unless your doctor tells you to.||
7125|110|B|||
7125|111|D|MISSED DOSE:  If you are using this product on a regular schedule||
7125|112|D|and miss a dose, apply it as soon as you remember. If it is near||
7125|113|D|the time for the next dose, skip the missed dose. Use your next||
7125|114|D|dose at the regular time. Do not apply more than the usual amount||
7125|115|D|to make up for the missed dose.||
7125|116|B|||
7125|117|R|STORAGE:  Refer to storage information from the manufacturer. If||
7125|118|R|you have questions about storage, ask your pharmacist. Do not||
7125|119|R|freeze. Keep all medications away from children and pets.||
7125|120|R|   Do not flush medications down the toilet or pour them into a||
7125|121|R|drain unless instructed to do so. Properly discard this product||
7125|122|R|when it is expired or no longer needed. Consult your pharmacist||
7125|123|R|or local waste disposal company.||
7125|124|B|||
7125|125|A|Information last revised November 2024.||
7125|126|A|Copyright(c) 2025 First Databank, Inc.||
7125|127|B|||
7126|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7126|002|Z|does NOT have all possible information about this product. This||
7126|003|Z|information does not assure that this product is safe, effective,||
7126|004|Z|or appropriate for you. This information is not individual||
7126|005|Z|medical advice and does not substitute for the advice of your||
7126|006|Z|health care professional. Always ask your health care||
7126|007|Z|professional for complete information about this product and your||
7126|008|Z|specific health needs.||
7126|009|B|||
7126|010|T|PRENATAL VITAMINS/MINERALS/OMEGA-3 FATTY ACIDS - ORAL||
7126|011|B|||
7126|012|W|WARNING:  Accidental overdose of iron-containing products is a||
7126|013|W|leading cause of fatal poisoning in children younger than 6||
7126|014|W|years. Keep this product out of reach of children. If overdose||
7126|015|W|does occur, get medical help right away or call a poison control||
7126|016|W|center.||
7126|017|B|||
7126|018|U|USES:  This medication is a multivitamin, mineral, and fatty acid||
7126|019|U|product used to treat or prevent vitamin deficiency before,||
7126|020|U|during, and after pregnancy. Vitamins, minerals, and fatty acids||
7126|021|U|are important building blocks of the body and help keep you in||
7126|022|U|good health.||
7126|023|U|   This combination product also contains iron and folic acid.||
7126|024|U|Women of childbearing age should maintain adequate levels of||
7126|025|U|folic acid either through diet or supplements to prevent infant||
7126|026|U|spinal cord defects in the developing baby.||
7126|027|B|||
7126|028|H|HOW TO USE:  Take this medication by mouth, usually once or twice||
7126|029|H|daily or as directed by your doctor. Follow all directions on the||
7126|030|H|product package, or take as directed by your doctor. If you are||
7126|031|H|taking the powder form of this medication, mix in water as||
7126|032|H|directed before swallowing. If you are taking the delayed-release||
7126|033|H|form of this medication, do not crush or chew. Doing so can||
7126|034|H|release all of the drug at once, increasing the risk of side||
7126|035|H|effects. If you are taking the chewable form of this medication,||
7126|036|H|chew thoroughly and then swallow.||
7126|037|H|   This medication is best taken on an empty stomach 1 hour||
7126|038|H|before or 2 hours after meals. Take with a full glass of water (8||
7126|039|H|ounces or 240 milliliters) unless your doctor directs you||
7126|040|H|otherwise. If stomach upset occurs, you may take this medication||
7126|041|H|with food. Avoid taking antacids, dairy products, tea, or coffee||
7126|042|H|within 2 hours before or after this medication because they will||
7126|043|H|decrease its effectiveness. Do not lie down for at least 10||
7126|044|H|minutes after taking this medication. Consult your doctor or||
7126|045|H|pharmacist for details for your particular brand.||
7126|046|H|   Take this medication regularly in order to get the most||
7126|047|H|benefit from it. To help you remember, take it at the same times||
7126|048|H|each day.||
7126|049|B|||
7126|050|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
7126|051|S|occur. These effects are usually temporary and may disappear as||
7126|052|S|your body adjusts to this medication. If any of these effects||
7126|053|S|last or get worse, tell your doctor or pharmacist promptly.||
7126|054|S|   Iron may cause your stools to turn black, an effect that is||
7126|055|S|not harmful.||
7126|056|S|   Remember that this medication has been prescribed because your||
7126|057|S|doctor has judged that the benefit to you is greater than the||
7126|058|S|risk of side effects. Many people using this medication do not||
7126|059|S|have serious side effects.||
7126|060|S|   Tell your doctor right away if you have any serious side||
7126|061|S|effects, including: easy bleeding/bruising.||
7126|062|S|   A very serious allergic reaction to this drug is rare.||
7126|063|S|However, get medical help right away if you notice any symptoms||
7126|064|S|of a serious allergic reaction, including: rash, itching/swelling||
7126|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7126|066|S|breathing.||
7126|067|S|   This is not a complete list of possible side effects. If you||
7126|068|S|notice other effects not listed above, contact your doctor or||
7126|069|S|pharmacist.||
7126|070|S|   In the US -||
7126|071|S|   Call your doctor for medical advice about side effects. You||
7126|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7126|073|S|www.fda.gov/medwatch.||
7126|074|S|   In Canada - Call your doctor for medical advice about side||
7126|075|S|effects. You may report side effects to Health Canada at||
7126|076|S|1-866-234-2345.||
7126|077|B|||
7126|078|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
7126|079|P|pharmacist if you are allergic to any of its ingredients; or to||
7126|080|P|fish or soy/peanut found in some brands; or if you have any other||
7126|081|P|allergies. This product may contain inactive ingredients, which||
7126|082|P|can cause allergic reactions or other problems. Talk to your||
7126|083|P|pharmacist for more details.||
7126|084|P|   Before taking this medication, tell your doctor or pharmacist||
7126|085|P|your medical history, especially of: iron overload disorder (such||
7126|086|P|as hemochromatosis, hemosiderosis), use/abuse of alcohol, liver||
7126|087|P|problems, stomach/intestinal problems (such as ulcer, colitis),||
7126|088|P|vitamin B12 deficiency (pernicious anemia), bleeding disorders.||
7126|089|P|   Before having surgery, tell your doctor or dentist about all||
7126|090|P|the products you use (including prescription drugs,||
7126|091|P|nonprescription drugs, and herbal products).||
7126|092|P|   This medication is safe to take during pregnancy when used as||
7126|093|P|directed.||
7126|094|P|   This medication passes into breast milk. Consult your doctor||
7126|095|P|before breastfeeding.||
7126|096|B|||
7126|097|I|DRUG INTERACTIONS:  See also How To Use section.||
7126|098|I|   Drug interactions may change how your medications work or||
7126|099|I|increase your risk for serious side effects. This document does||
7126|100|I|not contain all possible drug interactions. Keep a list of all||
7126|101|I|the products you use (including prescription/nonprescription||
7126|102|I|drugs and herbal products) and share it with your doctor and||
7126|103|I|pharmacist. Do not start, stop, or change the dosage of any||
7126|104|I|medicines without your doctor's approval.||
7126|105|I|   This product can decrease the absorption of certain drugs,||
7126|106|I|especially if you take them around the same time. These drugs||
7126|107|I|include bisphosphonates (such as alendronate), levodopa,||
7126|108|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
7126|109|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
7126|110|I|minocycline), thyroid medications (such as levothyroxine), among||
7126|111|I|others. Ask your doctor or pharmacist how long you should wait||
7126|112|I|between doses of this product and your other medications and to||
7126|113|I|find a dosing schedule that works for all your medications.||
7126|114|B|||
7126|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7126|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7126|117|O|poison control center right away. US residents can call||
7126|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7126|119|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
7126|120|O|diarrhea.||
7126|121|B|||
7126|122|N|NOTES:  Do not share this medication with others.||
7126|123|N|   Lab and/or medical tests (such as complete blood count,||
7126|124|N|vitamin B12 levels) may be done while you are taking this||
7126|125|N|product. Keep all medical and lab appointments. Consult your||
7126|126|N|doctor for more details.||
7126|127|N|   Some brands of prenatal vitamins also contain ingredients such||
7126|128|N|as calcium, zinc, iodine, or docusate. Consult your doctor or||
7126|129|N|pharmacist if you have questions about the ingredients in your||
7126|130|N|brand.||
7126|131|N|   This product is not a substitute for a proper diet. Remember||
7126|132|N|that it is best to get your vitamins and minerals from healthy||
7126|133|N|foods. Maintain a well-balanced diet and follow any dietary||
7126|134|N|guidelines as directed by your doctor.||
7126|135|B|||
7126|136|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7126|137|D|remember. If it is near the time of the next dose, skip the||
7126|138|D|missed dose. Take your next dose at the regular time. Do not||
7126|139|D|double the dose to catch up.||
7126|140|B|||
7126|141|R|STORAGE:  Store at room temperature away from light and moisture.||
7126|142|R|Do not store in the bathroom. Keep all medications away from||
7126|143|R|children and pets.||
7126|144|R|   Do not flush medications down the toilet or pour them into a||
7126|145|R|drain unless instructed to do so. Properly discard this product||
7126|146|R|when it is expired or no longer needed. Consult your pharmacist||
7126|147|R|or local waste disposal company.||
7126|148|B|||
7126|149|A|Information last revised October 2025.||
7126|150|A|Copyright(c) 2025 First Databank, Inc.||
7126|151|B|||
7128|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7128|002|Z|does NOT have all possible information about this product. This||
7128|003|Z|information does not assure that this product is safe, effective,||
7128|004|Z|or appropriate for you. This information is not individual||
7128|005|Z|medical advice and does not substitute for the advice of your||
7128|006|Z|health care professional. Always ask your health care||
7128|007|Z|professional for complete information about this product and your||
7128|008|Z|specific health needs.||
7128|009|B|||
7128|010|T|HYDROXYCHLOROQUINE - ORAL||
7128|011|F|(hi-DROX-ee-KLOR-oh-kwin)||
7128|012|B|||
7128|013|C|COMMON BRAND NAME(S): Plaquenil||
7128|014|B|||
7128|015|U|USES:  Hydroxychloroquine is used to prevent or treat malaria||
7128|016|U|caused by mosquito bites. The United States Center for Disease||
7128|017|U|Control provides updated guidelines and travel recommendations||
7128|018|U|for the prevention and treatment of malaria in different parts of||
7128|019|U|the world. Discuss the most recent information with your doctor||
7128|020|U|before traveling to areas where malaria occurs.||
7128|021|U|   This medication is also used to treat certain auto-immune||
7128|022|U|diseases (lupus, rheumatoid arthritis). It belongs to a class of||
7128|023|U|medications known as disease-modifying antirheumatic drugs||
7128|024|U|(DMARDs). It can reduce skin problems in lupus and prevent||
7128|025|U|swelling/pain in arthritis.||
7128|026|U|   Hydroxychloroquine is not recommended for coronavirus||
7128|027|U|infection, also known as COVID-19, unless you are enrolled in a||
7128|028|U|study. Talk to your doctor about the risks and benefits.||
7128|029|B|||
7128|030|V|OTHER USES:  This section contains uses of this drug that are not||
7128|031|V|listed in the approved professional labeling for the drug, but||
7128|032|V|may be prescribed by your health care professional. Use this drug||
7128|033|V|for a condition that is listed in this section only if it has||
7128|034|V|been so prescribed by your health care professional.||
7128|035|V|   This medication may also be used for other types of infections||
7128|036|V|(such as Q fever endocarditis).||
7128|037|B|||
7128|038|H|HOW TO USE:  Take this medication by mouth exactly as directed by||
7128|039|H|your doctor. To help prevent stomach upset, take it with food or||
7128|040|H|milk. Swallow the tablets whole since breaking or crushing them||
7128|041|H|may leave a bitter taste. The dosage and length of treatment are||
7128|042|H|based on your medical condition and response to treatment.||
7128|043|H|Children's dosage is also based on weight.||
7128|044|H|   To prevent malaria, take this medication by mouth as directed||
7128|045|H|by your doctor, usually once a week on the same day each week. To||
7128|046|H|help you remember, mark your calendar with a reminder. This drug||
7128|047|H|is usually started 1 to 2 weeks before entering the malarious||
7128|048|H|area. Continue to take it weekly while in the area and for 4 to 8||
7128|049|H|weeks after leaving the area, or as directed by your doctor. To||
7128|050|H|treat malaria, follow your doctor's instructions.||
7128|051|H|   For lupus or rheumatoid arthritis, take this medication by||
7128|052|H|mouth as directed by your doctor, usually once or twice daily.||
7128|053|H|Your doctor may gradually increase your dose. Once you have been||
7128|054|H|taking the medication for a while and your condition has||
7128|055|H|improved, your doctor may instruct you to lower your dose until||
7128|056|H|you find the dose that works best with the fewest side effects.||
7128|057|H|   If you are also taking a certain drug for diarrhea (kaolin) or||
7128|058|H|taking antacids (such as magnesium/aluminum hydroxide), take||
7128|059|H|hydroxychloroquine at least 4 hours before or after these||
7128|060|H|products. These products may bind with hydroxychloroquine,||
7128|061|H|preventing your body from fully absorbing it.||
7128|062|H|   Use this medication regularly in order to get the most benefit||
7128|063|H|from it. If you are taking it on a daily schedule, take it at the||
7128|064|H|same time(s) each day. Take this medication exactly as||
7128|065|H|prescribed. Do not stop taking it without talking with your||
7128|066|H|doctor, especially if you are taking it for malaria. It is||
7128|067|H|important to keep taking this for the length of time prescribed.||
7128|068|H|Stopping prevention or treatment too soon may lead to infection||
7128|069|H|or a return of the infection.||
7128|070|H|   Tell your doctor if your condition lasts or gets worse. It may||
7128|071|H|take several weeks or months to see improvement if you are taking||
7128|072|H|this for lupus or arthritis. Hydroxychloroquine may not prevent||
7128|073|H|malaria in all cases. If you experience fever or other symptoms||
7128|074|H|of illness, get medical help right away (especially while in the||
7128|075|H|malarious area and for 2 months after returning from the area).||
7128|076|H|You may need a different medication. Avoid exposure to||
7128|077|H|mosquitoes. (See also Notes section.)||
7128|078|B|||
7128|079|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, diarrhea,||
7128|080|S|dizziness, or headache may occur. If any of these effects last or||
7128|081|S|get worse, tell your doctor or pharmacist promptly.||
7128|082|S|   Remember that this medication has been prescribed because your||
7128|083|S|doctor has judged that the benefit to you is greater than the||
7128|084|S|risk of side effects. Many people using this medication do not||
7128|085|S|have serious side effects.||
7128|086|S|   Tell your doctor right away if you have any serious side||
7128|087|S|effects, including: slow heartbeat, symptoms of heart failure||
7128|088|S|(such as shortness of breath, swelling ankles/feet, unusual||
7128|089|S|tiredness, unusual/sudden weight gain), mental/mood changes (such||
7128|090|S|as anxiety, depression, rare thoughts of suicide,||
7128|091|S|hallucinations), hearing changes (such as ringing in the ears,||
7128|092|S|hearing loss), easy bruising/bleeding, signs of liver disease||
7128|093|S|(such as severe stomach/abdominal pain, yellowing eyes/skin, dark||
7128|094|S|urine), signs of kidney problems (such as change in the amount of||
7128|095|S|urine), muscle weakness, unwanted/uncontrolled movements||
7128|096|S|(including tongue/face twitching), hair loss, hair/skin color||
7128|097|S|changes.||
7128|098|S|   This medication may cause low blood sugar (hypoglycemia). Tell||
7128|099|S|your doctor right away if you develop symptoms of low blood||
7128|100|S|sugar, such as sudden sweating, shaking, hunger, blurred vision,||
7128|101|S|dizziness, or tingling hands/feet. If you have diabetes, be sure||
7128|102|S|to check your blood sugars regularly. Your doctor may need to||
7128|103|S|adjust your diabetes medication.||
7128|104|S|   Get medical help right away if you have any very serious side||
7128|105|S|effects, including: severe dizziness, fainting, fast/irregular||
7128|106|S|heartbeat, seizures.||
7128|107|S|   This medication may cause serious eye/vision problems. The||
7128|108|S|risk for these side effects is increased with long-term use of||
7128|109|S|this medication and with taking this medication in high doses.||
7128|110|S|Get medical help right away if you have any symptoms of serious||
7128|111|S|eye problems, including: sensitivity to light, vision changes||
7128|112|S|(such as light flashes/streaks, blurred vision, difficulty||
7128|113|S|reading, missing areas of vision).||
7128|114|S|   A very serious allergic reaction to this drug is rare.||
7128|115|S|However, get medical help right away if you notice any symptoms||
7128|116|S|of a serious allergic reaction, including: fever, swollen lymph||
7128|117|S|nodes, rash, itching/swelling (especially of the||
7128|118|S|face/tongue/throat), dizziness, trouble breathing.||
7128|119|S|   This is not a complete list of possible side effects. If you||
7128|120|S|notice other effects not listed above, contact your doctor or||
7128|121|S|pharmacist.||
7128|122|S|   In the US -||
7128|123|S|   Call your doctor for medical advice about side effects. You||
7128|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7128|125|S|www.fda.gov/medwatch.||
7128|126|S|   In Canada - Call your doctor for medical advice about side||
7128|127|S|effects. You may report side effects to Health Canada at||
7128|128|S|1-866-234-2345.||
7128|129|B|||
7128|130|P|PRECAUTIONS:  Before taking hydroxychloroquine, tell your doctor||
7128|131|P|or pharmacist if you are allergic to it; or to chloroquine; or if||
7128|132|P|you have any other allergies. This product may contain inactive||
7128|133|P|ingredients, which can cause allergic reactions or other||
7128|134|P|problems. Talk to your pharmacist for more details.||
7128|135|P|   Before using this medication, tell your doctor or pharmacist||
7128|136|P|your medical history, especially of: a certain enzyme problem||
7128|137|P|(glucose-6-phosphate dehydrogenase deficiency-G6PD), vision/eye||
7128|138|P|problems, hearing problems, kidney disease, liver disease,||
7128|139|P|regular alcohol use/abuse, skin problems (such as psoriasis), a||
7128|140|P|certain blood disorder (porphyria), seizures.||
7128|141|P|   If you have diabetes, this product may affect your blood||
7128|142|P|sugar. Check your blood sugar regularly as directed and share the||
7128|143|P|results with your doctor. Tell your doctor right away if you have||
7128|144|P|symptoms of low blood sugar (see Side Effects section). Your||
7128|145|P|doctor may need to adjust your diabetes medication, exercise||
7128|146|P|program, or diet.||
7128|147|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7128|148|P|can make you more dizzy. Do not drive, use machinery, or do||
7128|149|P|anything that needs alertness until you can do it safely. Avoid||
7128|150|P|alcoholic beverages. Talk to your doctor if you are using||
7128|151|P|marijuana (cannabis). Alcohol can also increase your risk of||
7128|152|P|liver problems while you are taking this drug.||
7128|153|P|   This medication may make you more sensitive to the sun. Limit||
7128|154|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
7128|155|P|sunscreen and wear protective clothing when outdoors. Tell your||
7128|156|P|doctor right away if you get sunburned or have skin||
7128|157|P|blisters/redness.||
7128|158|P|   Before having surgery, tell your doctor or dentist about all||
7128|159|P|the products you use (including prescription drugs,||
7128|160|P|nonprescription drugs, and herbal products).||
7128|161|P|   Hydroxychloroquine may cause a condition that affects the||
7128|162|P|heart rhythm (QT prolongation). QT prolongation can rarely cause||
7128|163|P|serious (rarely fatal) fast/irregular heartbeat and other||
7128|164|P|symptoms (such as severe dizziness, fainting) that need medical||
7128|165|P|attention right away.||
7128|166|P|   The risk of QT prolongation may be increased if you have||
7128|167|P|certain medical conditions or are taking other drugs that may||
7128|168|P|cause QT prolongation. Before using hydroxychloroquine, tell your||
7128|169|P|doctor or pharmacist of all the drugs you take and if you have||
7128|170|P|any of the following conditions: certain heart problems (heart||
7128|171|P|failure, slow heartbeat, QT prolongation in the EKG), family||
7128|172|P|history of certain heart problems (QT prolongation in the EKG,||
7128|173|P|sudden cardiac death).||
7128|174|P|   Low levels of potassium or magnesium in the blood may also||
7128|175|P|increase your risk of QT prolongation. This risk may increase if||
7128|176|P|you use certain drugs (such as diuretics/"water pills") or if you||
7128|177|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7128|178|P|Talk to your doctor about using hydroxychloroquine safely.||
7128|179|P|   Older adults may be more sensitive to the side effects of this||
7128|180|P|drug, especially QT prolongation (see above).||
7128|181|P|   During pregnancy, this medication should be used only when||
7128|182|P|clearly needed. Discuss the risks and benefits with your doctor.||
7128|183|P|   This medication passes into breast milk. Consult your doctor||
7128|184|P|before breastfeeding.||
7128|185|B|||
7128|186|I|DRUG INTERACTIONS:  See also How to Use section.||
7128|187|I|   Drug interactions may change how your medications work or||
7128|188|I|increase your risk for serious side effects. This document does||
7128|189|I|not contain all possible drug interactions. Keep a list of all||
7128|190|I|the products you use (including prescription/nonprescription||
7128|191|I|drugs and herbal products) and share it with your doctor and||
7128|192|I|pharmacist. Do not start, stop, or change the dosage of any||
7128|193|I|medicines without your doctor's approval.||
7128|194|I|   Some products that may interact with this drug are:||
7128|195|I|mefloquine, penicillamine, remdesivir.||
7128|196|I|   Many drugs besides hydroxychloroquine may affect the heart||
7128|197|I|rhythm (QT prolongation), including amiodarone, azithromycin,||
7128|198|I|disopyramide, dronedarone, pimozide, quinidine, among others.||
7128|199|B|||
7128|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7128|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7128|202|O|poison control center right away. US residents can call||
7128|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7128|204|O|Symptoms of overdose may include: fast/irregular heartbeat,||
7128|205|O|fainting, slow/shallow breathing, seizures.||
7128|206|B|||
7128|207|N|NOTES:  Do not share this medication with others.||
7128|208|N|   Lab and/or medical tests (such as eye exams, reflex tests,||
7128|209|N|liver/kidney function, EKG, complete blood counts) should be done||
7128|210|N|if you are taking hydroxychloroquine for a long time. Keep all||
7128|211|N|medical and lab appointments. Consult your doctor for more||
7128|212|N|details.||
7128|213|N|   When traveling in an area at risk for malaria, use protective||
7128|214|N|clothing, insect repellent, and bed nets. Remain indoors or in||
7128|215|N|well-screened areas when possible. If you are taking this||
7128|216|N|medication to prevent or treat malaria, use it for your current||
7128|217|N|travel or condition only. Do not use it later to prevent or treat||
7128|218|N|another infection unless your doctor tells you to.||
7128|219|B|||
7128|220|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7128|221|D|remember. If it is near the time of the next dose, skip the||
7128|222|D|missed dose. Take your next dose at the regular time. Do not||
7128|223|D|double the dose to catch up.||
7128|224|B|||
7128|225|R|STORAGE:  Store at room temperature away from moisture and light.||
7128|226|R|Do not store in the bathroom. Keep all medications away from||
7128|227|R|children and pets.||
7128|228|R|   Do not flush medications down the toilet or pour them into a||
7128|229|R|drain unless instructed to do so. Properly discard this product||
7128|230|R|when it is expired or no longer needed. Consult your pharmacist||
7128|231|R|or local waste disposal company.||
7128|232|B|||
7128|233|A|Information last revised October 2024.||
7128|234|A|Copyright(c) 2025 First Databank, Inc.||
7128|235|B|||
7130|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7130|002|Z|does NOT have all possible information about this product. This||
7130|003|Z|information does not assure that this product is safe, effective,||
7130|004|Z|or appropriate for you. This information is not individual||
7130|005|Z|medical advice and does not substitute for the advice of your||
7130|006|Z|health care professional. Always ask your health care||
7130|007|Z|professional for complete information about this product and your||
7130|008|Z|specific health needs.||
7130|009|B|||
7130|010|T|SULFACETAMIDE/SULFUR CLEANSER - TOPICAL||
7130|011|F|(sull-fuh-SEET-uh-mide/SULL-fur)||
7130|012|B|||
7130|013|C|COMMON BRAND NAME(S): Avar, Plexion, Rosanil Cleanser, Rosula||
7130|014|B|||
7130|015|U|USES:  This medication is used as a cleansing product to help||
7130|016|U|treat acne and other skin conditions (such as seborrheic||
7130|017|U|dermatitis, rosacea). This product contains an antibacterial||
7130|018|U|agent and a drying agent which promotes shedding of the top layer||
7130|019|U|of skin (keratolysis).||
7130|020|B|||
7130|021|H|HOW TO USE:  This medication is for use on the skin only. Clean||
7130|022|H|off make-up, oil and excess dirt from your face with a gentle||
7130|023|H|cleanser before using this product. Wet the affected areas of||
7130|024|H|skin before washing with this medication.||
7130|025|H|   If your liquid form is a suspension, shake the bottle well||
7130|026|H|before each use.||
7130|027|H|   If you are using the liquid cleanser product, apply a generous||
7130|028|H|layer of medication as directed by your doctor, usually once or||
7130|029|H|twice daily. Gently massage it into the affected skin for 10 to||
7130|030|H|20 seconds until a full lather forms. Rinse thoroughly and pat||
7130|031|H|dry.||
7130|032|H|   If you are using the cleansing cloth product, wash the||
7130|033|H|affected areas with a cleansing cloth as directed by your doctor,||
7130|034|H|usually once or twice daily. First wet your face with water. Then||
7130|035|H|wet the cloth with a little water and work into a full lather.||
7130|036|H|Cleanse your face with the cloth for 10-20 seconds. Do not get||
7130|037|H|the lather into your eyes. Rinse thoroughly and pat dry.||
7130|038|H|   If excessive drying occurs, you may need to rinse the cleanser||
7130|039|H|off sooner or use it less often. Avoid getting any of this||
7130|040|H|medication in the eyes, on the lips, or inside the nose or mouth.||
7130|041|H|Consult your doctor or pharmacist for further details.||
7130|042|H|   Tell your doctor if your condition does not get better or if||
7130|043|H|it gets worse.||
7130|044|B|||
7130|045|S|SIDE EFFECTS:  Redness, irritation or scaling of the skin may||
7130|046|S|occur. If any of these effects last or get worse, tell your||
7130|047|S|doctor promptly.||
7130|048|S|   Remember that this medication has been prescribed because your||
7130|049|S|doctor has judged that the benefit to you is greater than the||
7130|050|S|risk of side effects. Many people using this medication do not||
7130|051|S|have serious side effects.||
7130|052|S|   Tell your doctor right away if you have any serious side||
7130|053|S|effects, including: cracked skin, unusual weakness/tiredness,||
7130|054|S|signs of liver problems (such as dark urine, yellowing||
7130|055|S|eyes/skin), signs of infection (such as sore throat that doesn't||
7130|056|S|go away, fever, chills), easy bruising/bleeding, aching/swollen||
7130|057|S|joints.||
7130|058|S|   You may be at increased risk for side effects if this||
7130|059|S|medication is used on raw or broken skin. Consult your doctor for||
7130|060|S|details.||
7130|061|S|   A very serious allergic reaction to this drug is rare.||
7130|062|S|However, get medical help right away if you notice any symptoms||
7130|063|S|of a serious allergic reaction, including: rash, itching/swelling||
7130|064|S|(especially of the face/tongue/throat), dizziness, trouble||
7130|065|S|breathing.||
7130|066|S|   This is not a complete list of possible side effects. If you||
7130|067|S|notice other effects not listed above, contact your doctor or||
7130|068|S|pharmacist.||
7130|069|S|   In the US -||
7130|070|S|   Call your doctor for medical advice about side effects. You||
7130|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7130|072|S|www.fda.gov/medwatch.||
7130|073|S|   In Canada - Call your doctor for medical advice about side||
7130|074|S|effects. You may report side effects to Health Canada at||
7130|075|S|1-866-234-2345.||
7130|076|B|||
7130|077|P|PRECAUTIONS:  Before using sulfacetamide with sulfur, tell your||
7130|078|P|doctor or pharmacist if you are allergic to it; or to other||
7130|079|P|products containing sulfa or sulfur; or if you have any other||
7130|080|P|allergies. This product may contain inactive ingredients, which||
7130|081|P|can cause allergic reactions or other problems. Talk to your||
7130|082|P|pharmacist for more details.||
7130|083|P|   Before using this medication, tell your doctor or pharmacist||
7130|084|P|your medical history, especially of: kidney disease.||
7130|085|P|   Before having surgery, tell your doctor or dentist about all||
7130|086|P|the products you use (including prescription drugs,||
7130|087|P|nonprescription drugs, and herbal products).||
7130|088|P|   During pregnancy, this medication should be used only when||
7130|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
7130|090|P|   Based on information of related drugs, this medication may||
7130|091|P|pass into breast milk. Consult your doctor before breastfeeding.||
7130|092|B|||
7130|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7130|094|I|medications work or increase your risk for serious side effects.||
7130|095|I|This document does not contain all possible drug interactions.||
7130|096|I|Keep a list of all the products you use (including||
7130|097|I|prescription/nonprescription drugs and herbal products) and share||
7130|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
7130|099|I|the dosage of any medicines without your doctor's approval.||
7130|100|I|   Some products that may interact with this drug are: skin||
7130|101|I|products containing silver (such as silver sulfadiazine).||
7130|102|B|||
7130|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7130|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7130|105|O|poison control center right away. US residents can call||
7130|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
7130|107|O|medicine may be harmful if swallowed.||
7130|108|B|||
7130|109|N|NOTES:  Do not share this medication with others.||
7130|110|B|||
7130|111|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7130|112|D|If it is near the time of the next dose, skip the missed dose.||
7130|113|D|Use your next dose at the regular time. Do not double the dose to||
7130|114|D|catch up.||
7130|115|B|||
7130|116|R|STORAGE:  Store at room temperature. Keep all medications away||
7130|117|R|from children and pets.||
7130|118|R|   Do not flush medications down the toilet or pour them into a||
7130|119|R|drain unless instructed to do so. Properly discard this product||
7130|120|R|when it is expired or no longer needed. Consult your pharmacist||
7130|121|R|or local waste disposal company.||
7130|122|B|||
7130|123|A|Information last revised May 2025.||
7130|124|A|Copyright(c) 2025 First Databank, Inc.||
7130|125|B|||
7132|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7132|002|Z|does NOT have all possible information about this product. This||
7132|003|Z|information does not assure that this product is safe, effective,||
7132|004|Z|or appropriate for you. This information is not individual||
7132|005|Z|medical advice and does not substitute for the advice of your||
7132|006|Z|health care professional. Always ask your health care||
7132|007|Z|professional for complete information about this product and your||
7132|008|Z|specific health needs.||
7132|009|B|||
7132|010|T|DRONABINOL - ORAL||
7132|011|F|(dro-NAB-in-all)||
7132|012|B|||
7132|013|C|COMMON BRAND NAME(S): Marinol||
7132|014|B|||
7132|015|U|USES:  Dronabinol is used to treat nausea and vomiting caused by||
7132|016|U|cancer chemotherapy. It is usually used when other drugs to||
7132|017|U|control nausea and vomiting have not been successful. Dronabinol||
7132|018|U|is also used to treat loss of appetite and weight loss in||
7132|019|U|patients with HIV infection. Dronabinol (also called THC) is a||
7132|020|U|man-made form of the active natural substance in marijuana||
7132|021|U|(cannabis).||
7132|022|B|||
7132|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7132|024|H|from your pharmacist before you start taking dronabinol and each||
7132|025|H|time you get a refill. If you have any questions, ask your doctor||
7132|026|H|or pharmacist.||
7132|027|H|   Take this medication by mouth as directed by your doctor,||
7132|028|H|usually up to 4 to 6 times daily if you are taking it to control||
7132|029|H|nausea and vomiting or twice daily (before lunch and before||
7132|030|H|dinner) if you are taking it to treat appetite loss. Follow your||
7132|031|H|doctor's instructions carefully.||
7132|032|H|   The dosage is based on your medical condition and response to||
7132|033|H|treatment. If you are taking this medication to control nausea||
7132|034|H|and vomiting, your dosage may also be based on your body size.||
7132|035|H|   Do not increase your dose or use this drug more often or for||
7132|036|H|longer than prescribed. Your condition will not improve any||
7132|037|H|faster, and your risk of serious side effects will increase.||
7132|038|H|   If you suddenly stop using this medication, you may have||
7132|039|H|withdrawal symptoms (such as irritability, trouble sleeping,||
7132|040|H|restlessness, hot flashes, diarrhea). To help prevent withdrawal,||
7132|041|H|your doctor may lower your dose slowly. Withdrawal is more likely||
7132|042|H|if you have used dronabinol for a long time or in high doses.||
7132|043|H|Tell your doctor or pharmacist right away if you have withdrawal.||
7132|044|H|   Though it helps many people, this medication may sometimes||
7132|045|H|cause addiction. This risk may be higher if you have a substance||
7132|046|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
7132|047|H|Take this medication exactly as prescribed to lower the risk of||
7132|048|H|addiction. Ask your doctor or pharmacist for more details.||
7132|049|H|   Tell your doctor if your condition lasts or gets worse.||
7132|050|B|||
7132|051|S|SIDE EFFECTS:  Dizziness, drowsiness, confusion, feeling "high",||
7132|052|S|an exaggerated sense of well-being, lightheadedness, nausea,||
7132|053|S|vomiting, or stomach/abdominal pain may occur as your body||
7132|054|S|adjusts to the medication. If any of these effects last or get||
7132|055|S|worse, tell your doctor or pharmacist promptly.||
7132|056|S|   To reduce the risk of dizziness and lightheadedness, get up||
7132|057|S|slowly when rising from a sitting or lying position.||
7132|058|S|   Remember that this medication has been prescribed because your||
7132|059|S|doctor has judged that the benefit to you is greater than the||
7132|060|S|risk of side effects. Many people using this medication do not||
7132|061|S|have serious side effects.||
7132|062|S|   Tell your doctor right away if you have any serious side||
7132|063|S|effects, including: fainting, fast/pounding heartbeat,||
7132|064|S|mental/mood changes (such as anxiety, nervousness,||
7132|065|S|hallucinations, abnormal thoughts, paranoia).||
7132|066|S|   A very serious allergic reaction to this drug is rare.||
7132|067|S|However, get medical help right away if you notice any symptoms||
7132|068|S|of a serious allergic reaction, including: rash, itching/swelling||
7132|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7132|070|S|breathing.||
7132|071|S|   This is not a complete list of possible side effects. If you||
7132|072|S|notice other effects not listed above, contact your doctor or||
7132|073|S|pharmacist.||
7132|074|S|   In the US -||
7132|075|S|   Call your doctor for medical advice about side effects. You||
7132|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7132|077|S|www.fda.gov/medwatch.||
7132|078|S|   In Canada - Call your doctor for medical advice about side||
7132|079|S|effects. You may report side effects to Health Canada at||
7132|080|S|1-866-234-2345.||
7132|081|B|||
7132|082|P|PRECAUTIONS:  Before taking dronabinol, tell your doctor or||
7132|083|P|pharmacist if you are allergic to it; or to marijuana (cannabis);||
7132|084|P|or if you have any other allergies. This product may contain||
7132|085|P|inactive ingredients (such as sesame oil), which can cause||
7132|086|P|allergic reactions or other problems. Talk to your pharmacist for||
7132|087|P|more details.||
7132|088|P|   Before using this medication, tell your doctor or pharmacist||
7132|089|P|your medical history, especially of: personal or family history||
7132|090|P|of a substance use disorder (such as overuse of or addiction to||
7132|091|P|drugs/alcohol), heart disease, high blood pressure, mental/mood||
7132|092|P|disorders (such as mania, depression, schizophrenia), seizures.||
7132|093|P|   This drug may make you dizzy or drowsy or affect your||
7132|094|P|judgment. Alcohol or marijuana (cannabis) can worsen these||
7132|095|P|effects. Do not drive, use machinery, or do anything that needs||
7132|096|P|alertness until you can do it safely. Avoid alcoholic beverages.||
7132|097|P|Talk to your doctor if you are using marijuana (cannabis).||
7132|098|P|   Before having surgery, tell your doctor or dentist about all||
7132|099|P|the products you use (including prescription drugs,||
7132|100|P|nonprescription drugs, and herbal products).||
7132|101|P|   Children may be more sensitive to the side effects of this||
7132|102|P|drug, especially drowsiness and mental/mood changes.||
7132|103|P|   Older adults may be more sensitive to the side effects of this||
7132|104|P|drug, especially drowsiness, dizziness, lightheadedness, and||
7132|105|P|mental/mood changes.||
7132|106|P|   Tell your doctor if you are pregnant or plan to become||
7132|107|P|pregnant. You should not become pregnant while using dronabinol.||
7132|108|P|Dronabinol may harm an unborn baby. If you become pregnant, talk||
7132|109|P|to your doctor right away about the risks and benefits of this||
7132|110|P|medication.||
7132|111|P|   This medication passes into breast milk and may harm a nursing||
7132|112|P|infant. Breastfeeding is not recommended while using this||
7132|113|P|medication. Consult your doctor before breastfeeding.||
7132|114|B|||
7132|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7132|116|I|medications work or increase your risk for serious side effects.||
7132|117|I|This document does not contain all possible drug interactions.||
7132|118|I|Keep a list of all the products you use (including||
7132|119|I|prescription/nonprescription drugs and herbal products) and share||
7132|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
7132|121|I|the dosage of any medicines without your doctor's approval.||
7132|122|I|   Tell your doctor or pharmacist if you are taking other||
7132|123|I|products that cause drowsiness such as opioid pain or cough||
7132|124|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7132|125|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
7132|126|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7132|127|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7132|128|I|diphenhydramine).||
7132|129|I|   Check the labels on all your medicines (such as allergy or||
7132|130|I|cough-and-cold products) because they may contain ingredients||
7132|131|I|that cause drowsiness. Ask your pharmacist about using those||
7132|132|I|products safely.||
7132|133|B|||
7132|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7132|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7132|136|O|poison control center right away. US residents can call||
7132|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7132|138|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
7132|139|O|fast heartbeat, mental/mood changes, seizures.||
7132|140|B|||
7132|141|N|NOTES:  Do not share this medication with others. Sharing it is||
7132|142|N|against the law.||
7132|143|N|   Keep all medical appointments so your doctor can monitor your||
7132|144|N|response to treatment (such as your weight) and check for side||
7132|145|N|effects.||
7132|146|B|||
7132|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7132|148|D|remember. If it is near the time of the next dose, skip the||
7132|149|D|missed dose. Take your next dose at the regular time. Do not||
7132|150|D|double the dose to catch up.||
7132|151|B|||
7132|152|R|STORAGE:  Different brands of this medication have different||
7132|153|R|storage needs. Check the product package for instructions on how||
7132|154|R|to store your brand, or ask your pharmacist. Keep all medications||
7132|155|R|away from children and pets.||
7132|156|R|   Do not flush medications down the toilet or pour them into a||
7132|157|R|drain unless instructed to do so. Properly discard this product||
7132|158|R|when it is expired or no longer needed. Consult your pharmacist||
7132|159|R|or local waste disposal company.||
7132|160|B|||
7132|161|A|Information last revised September 2024.||
7132|162|A|Copyright(c) 2025 First Databank, Inc.||
7132|163|B|||
7133|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7133|002|Z|does NOT have all possible information about this product. This||
7133|003|Z|information does not assure that this product is safe, effective,||
7133|004|Z|or appropriate for you. This information is not individual||
7133|005|Z|medical advice and does not substitute for the advice of your||
7133|006|Z|health care professional. Always ask your health care||
7133|007|Z|professional for complete information about this product and your||
7133|008|Z|specific health needs.||
7133|009|B|||
7133|010|T|ETOPOSIDE - INJECTION||
7133|011|F|(e-TOE-poe-side)||
7133|012|B|||
7133|013|C|COMMON BRAND NAME(S): Toposar||
7133|014|B|||
7133|015|W|WARNING:  This medication may cause certain severe blood and bone||
7133|016|W|marrow problems (low red blood cells/white blood||
7133|017|W|cells/platelets). This can affect your body's ability to stop||
7133|018|W|bleeding or fight infection. Tell your doctor right away if you||
7133|019|W|develop unusual tiredness, signs of infection (such as sore||
7133|020|W|throat that doesn't go away, fever, chills), or easy||
7133|021|W|bruising/bleeding (such as black stools, bloody vomit).||
7133|022|B|||
7133|023|U|USES:  Etoposide is used to treat testicular cancer and certain||
7133|024|U|forms of lung cancer (such as small cell lung cancer). Etoposide||
7133|025|U|works by slowing the growth of cancer cells.||
7133|026|B|||
7133|027|V|OTHER USES:  This section contains uses of this drug that are not||
7133|028|V|listed in the approved professional labeling for the drug but||
7133|029|V|that may be prescribed by your health care professional. Use this||
7133|030|V|drug for a condition that is listed in this section only if it||
7133|031|V|has been so prescribed by your health care professional.||
7133|032|V|   This drug may also be used for other types of cancer (such as||
7133|033|V|leukemias, lymphomas, ovarian cancer, bone cancer, prostate||
7133|034|V|cancer).||
7133|035|B|||
7133|036|H|HOW TO USE:  This medication is given by slow injection into a||
7133|037|H|vein by a health care professional. It is given as directed by||
7133|038|H|your doctor, usually over 30 to 60 minutes every day or every||
7133|039|H|other day for a total of 3 to 5 doses. This cycle may be repeated||
7133|040|H|every 3 to 4 weeks.||
7133|041|H|   This medication may cause low blood pressure. Tell your doctor||
7133|042|H|or other health care professional if you feel dizzy. Your||
7133|043|H|injection may need to be stopped or given more slowly.||
7133|044|H|   The dosage is based on your medical condition, body size, and||
7133|045|H|response to treatment. Your doctor will check your blood counts||
7133|046|H|to make sure you can receive your next cycle. Keep all regular||
7133|047|H|medical and lab appointments.||
7133|048|B|||
7133|049|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
7133|050|S|   Nausea, vomiting, diarrhea, dizziness, tiredness, weakness,||
7133|051|S|changes in taste, loss of appetite, and pain/redness at the||
7133|052|S|injection site may occur. Nausea and vomiting can be severe. In||
7133|053|S|some cases, your doctor may prescribe medication to prevent or||
7133|054|S|relieve nausea and vomiting. Eating several small meals, not||
7133|055|S|eating before treatment, or limiting activity may help lessen||
7133|056|S|some of these effects. If any of these effects last or get worse,||
7133|057|S|tell your doctor or pharmacist promptly.||
7133|058|S|   Temporary hair loss may occur. Normal hair growth should||
7133|059|S|return after treatment has ended.||
7133|060|S|   Pain or sores in the mouth and throat may occur. Brush your||
7133|061|S|teeth carefully/gently, avoid using mouthwash that contains||
7133|062|S|alcohol, and rinse your mouth often with cool water mixed with||
7133|063|S|baking soda or salt. It may also be best to eat soft, moist||
7133|064|S|foods.||
7133|065|S|   Many people using this medication may have serious side||
7133|066|S|effects. However, you have been prescribed this drug because your||
7133|067|S|doctor has judged that the benefit to you is greater than the||
7133|068|S|risk of side effects. Careful monitoring by your doctor may||
7133|069|S|decrease your risk.||
7133|070|S|   Tell your doctor right away if you have any serious side||
7133|071|S|effects, including: numbness/tingling of arms/legs, sudden vision||
7133|072|S|changes, eye pain, stomach/abdominal pain, yellowing eyes/skin,||
7133|073|S|dark urine, painful/difficult swallowing, redness/swelling of||
7133|074|S|your veins.||
7133|075|S|   This medication may lower your ability to fight infections.||
7133|076|S|This may make you more likely to get a serious (rarely fatal)||
7133|077|S|infection or make any infection you have worse. Tell your doctor||
7133|078|S|right away if you have any signs of infection (such as sore||
7133|079|S|throat that doesn't go away, fever, chills).||
7133|080|S|   Although etoposide may be used to treat certain leukemias, it||
7133|081|S|may rarely cause acute leukemia. Ask your doctor for more||
7133|082|S|details.||
7133|083|S|   A very serious allergic reaction to this drug is rare.||
7133|084|S|However, get medical help right away if you notice any symptoms||
7133|085|S|of a serious allergic reaction, including: rash, itching/swelling||
7133|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7133|087|S|breathing, fast heartbeat, seizures.||
7133|088|S|   This is not a complete list of possible side effects. If you||
7133|089|S|notice other effects not listed above, contact your doctor or||
7133|090|S|pharmacist.||
7133|091|S|   In the US -||
7133|092|S|   Call your doctor for medical advice about side effects. You||
7133|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7133|094|S|www.fda.gov/medwatch.||
7133|095|S|   In Canada - Call your doctor for medical advice about side||
7133|096|S|effects. You may report side effects to Health Canada at||
7133|097|S|1-866-234-2345.||
7133|098|B|||
7133|099|P|PRECAUTIONS:  Before using etoposide, tell your doctor or||
7133|100|P|pharmacist if you are allergic to it; or if you have any other||
7133|101|P|allergies. This product may contain inactive ingredients, which||
7133|102|P|can cause allergic reactions or other problems. Talk to your||
7133|103|P|pharmacist for more details.||
7133|104|P|   Before using this medication, tell your doctor or pharmacist||
7133|105|P|your medical history, especially of: blood problems (such as low||
7133|106|P|red blood cells/white blood cells/platelets), liver disease,||
7133|107|P|kidney disease, previous radiation/chemotherapy treatment, heart||
7133|108|P|problems.||
7133|109|P|   Etoposide can make you more likely to get infections or may||
7133|110|P|make current infections worse. Stay away from anyone who has an||
7133|111|P|infection that may easily spread (such as chickenpox, COVID-19,||
7133|112|P|measles, flu). Talk to your doctor if you have been exposed to an||
7133|113|P|infection or for more details.||
7133|114|P|   Tell your health care professional that you are using||
7133|115|P|etoposide before having any immunizations/vaccinations. Avoid||
7133|116|P|contact with people who have recently received live vaccines||
7133|117|P|(such as flu vaccine inhaled through the nose).||
7133|118|P|   To lower the chance of getting cut, bruised, or injured, use||
7133|119|P|caution with sharp objects like razors and nail cutters, and||
7133|120|P|avoid activities such as contact sports.||
7133|121|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7133|122|P|can make you more dizzy. Do not drive, use machinery, or do||
7133|123|P|anything that needs alertness until you can do it safely. Limit||
7133|124|P|alcoholic beverages. Talk to your doctor if you are using||
7133|125|P|marijuana (cannabis).||
7133|126|P|   Daily use of alcohol while using this medicine may increase||
7133|127|P|your risk for stomach bleeding. Ask your doctor or pharmacist||
7133|128|P|about how much alcohol you may safely drink.||
7133|129|P|   Before having surgery, tell your doctor or dentist about all||
7133|130|P|the products you use (including prescription drugs,||
7133|131|P|nonprescription drugs, and herbal products).||
7133|132|P|   Children may be more sensitive to the side effects of this||
7133|133|P|drug, especially allergic effects.||
7133|134|P|   Older adults may be more sensitive to the side effects of this||
7133|135|P|drug, especially drowsiness, weakness, mouth/throat sores, loss||
7133|136|P|of appetite, low white blood cells, and dehydration.||
7133|137|P|   This medication can affect fertility in both males and||
7133|138|P|females. Ask your doctor for more details.||
7133|139|P|   Tell your doctor if you are pregnant or plan to become||
7133|140|P|pregnant. You should not become pregnant while using etoposide.||
7133|141|P|Etoposide may harm an unborn baby. Women using this medication||
7133|142|P|should ask about reliable forms of birth control during treatment||
7133|143|P|and for 6 months after the last dose. Men using this medication||
7133|144|P|should ask about reliable forms of birth control during treatment||
7133|145|P|and for 4 months after the last dose. If you or your partner||
7133|146|P|becomes pregnant, talk to your doctor right away about the risks||
7133|147|P|and benefits of this medication.||
7133|148|P|   Etoposide passes into breast milk. Because of the possible||
7133|149|P|risk to the infant, breastfeeding is not recommended while using||
7133|150|P|this medication. Consult your doctor before breastfeeding.||
7133|151|B|||
7133|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7133|153|I|medications work or increase your risk for serious side effects.||
7133|154|I|This document does not contain all possible drug interactions.||
7133|155|I|Keep a list of all the products you use (including||
7133|156|I|prescription/nonprescription drugs and herbal products) and share||
7133|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
7133|158|I|the dosage of any medicines without your doctor's approval.||
7133|159|B|||
7133|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7133|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7133|162|O|poison control center right away. US residents can call||
7133|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7133|164|B|||
7133|165|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
7133|166|N|kidney/liver function) should be done while you are using this||
7133|167|N|medication. Keep all medical and lab appointments. Consult your||
7133|168|N|doctor for more details.||
7133|169|B|||
7133|170|D|MISSED DOSE:  It is important to get each dose of this medication||
7133|171|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7133|172|D|right away for a new dosing schedule.||
7133|173|B|||
7133|174|R|STORAGE:  Consult the product instructions and your pharmacist||
7133|175|R|for storage details. Keep all medications away from children and||
7133|176|R|pets.||
7133|177|R|   Do not flush medications down the toilet or pour them into a||
7133|178|R|drain unless instructed to do so. Properly discard this product||
7133|179|R|when it is expired or no longer needed. Consult your pharmacist||
7133|180|R|or local waste disposal company.||
7133|181|B|||
7133|182|M|MEDICAL ALERT:  Your condition can cause complications in a||
7133|183|M|medical emergency. For information about enrolling in MedicAlert,||
7133|184|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7133|185|B|||
7133|186|A|Information last revised May 2025.||
7133|187|A|Copyright(c) 2025 First Databank, Inc.||
7133|188|B|||
7134|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7134|002|Z|does NOT have all possible information about this product. This||
7134|003|Z|information does not assure that this product is safe, effective,||
7134|004|Z|or appropriate for you. This information is not individual||
7134|005|Z|medical advice and does not substitute for the advice of your||
7134|006|Z|health care professional. Always ask your health care||
7134|007|Z|professional for complete information about this product and your||
7134|008|Z|specific health needs.||
7134|009|B|||
7134|010|T|DOXORUBICIN - INJECTION||
7134|011|F|(dox-oh-REW-beh-sin)||
7134|012|B|||
7134|013|C|COMMON BRAND NAME(S): Adriamycin, Rubex||
7134|014|B|||
7134|015|W|WARNING:  This medication must be given slowly into a vein only.||
7134|016|W|It is very important not to inject this medication into a muscle||
7134|017|W|or beneath the skin. If this medication accidentally leaks into||
7134|018|W|surrounding tissue, the skin/muscle may be severely damaged.||
7134|019|W|Notify your doctor right away if redness, blistering, sores,||
7134|020|W|pain, or swelling occur at or near the injection site.||
7134|021|W|   Doxorubicin may cause heart problems, including possibly fatal||
7134|022|W|heart failure. Heart problems may occur during doxorubicin||
7134|023|W|therapy or months to years after receiving this medication. Your||
7134|024|W|risk of developing heart problems depends on your dose, medical||
7134|025|W|history (including previous heart disease, radiation therapy in||
7134|026|W|the chest area), and previous use of this and other drugs||
7134|027|W|(including daunorubicin and cyclophosphamide). Children are at||
7134|028|W|higher risk and should be monitored later in life for delayed||
7134|029|W|heart problems. See also Side Effects section.||
7134|030|W|   Very rarely, people with cancer who are treated with this type||
7134|031|W|of medication have developed other cancers (such as secondary||
7134|032|W|leukemia). The risk is greater if you are over age 50 or have||
7134|033|W|received certain types of chemotherapy or radiation therapy.||
7134|034|W|Consult your doctor for more details.||
7134|035|W|   This medication may cause certain severe (rarely fatal) blood||
7134|036|W|disorders (bone marrow suppression leading to low red blood||
7134|037|W|cells/white blood cells /platelets). This can lower your body's||
7134|038|W|ability to fight infection and stop bleeding. Tell your doctor||
7134|039|W|right away if you develop any signs of infection (such as sore||
7134|040|W|throat that doesn't go away, fever, chills), unusual tiredness,||
7134|041|W|or easy bleeding/bruising.||
7134|042|W|   Your doctor will closely monitor you while you are being||
7134|043|W|treated with this medication.||
7134|044|W|   Different types of this medication work in different ways. Do||
7134|045|W|not switch types of this medication without your doctor's||
7134|046|W|permission.||
7134|047|B|||
7134|048|U|USES:  Doxorubicin is an anthracycline type of chemotherapy that||
7134|049|U|is used to treat several different types of cancer. Doxorubicin||
7134|050|U|works by slowing or stopping the growth of cancer cells.||
7134|051|B|||
7134|052|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7134|053|H|from your pharmacist before you start receiving doxorubicin and||
7134|054|H|each time you get an infusion. If you have any questions, ask||
7134|055|H|your doctor or pharmacist.||
7134|056|H|   This medication is given by injection into a vein by a health||
7134|057|H|care professional. The dosage is based on your medical condition,||
7134|058|H|body size, and response to treatment.||
7134|059|H|   If this medication touches your skin, immediately and||
7134|060|H|completely wash the skin with soap and water. If this medication||
7134|061|H|gets in your eye, open the eyelids and flush with plenty of water||
7134|062|H|for 15 minutes. Get medical help right away.||
7134|063|H|   Caregivers should take precautions (such as wear gloves) to||
7134|064|H|prevent contact with the patient's urine or other body fluid for||
7134|065|H|at least 5 days after treatment. Consult your pharmacist.||
7134|066|H|   Unless your doctor instructs you otherwise, drink plenty of||
7134|067|H|cool fluids during treatment with this medication. This helps||
7134|068|H|move the drug quickly through your body and helps reduce some of||
7134|069|H|the side effects.||
7134|070|B|||
7134|071|S|SIDE EFFECTS:  See also Warning section.||
7134|072|S|   Nausea, vomiting, diarrhea, and loss of appetite may occur.||
7134|073|S|Nausea and vomiting can be severe. In some cases, drug therapy||
7134|074|S|may be needed to prevent or relieve nausea and vomiting. Not||
7134|075|S|eating before your treatment may help relieve vomiting. Changes||
7134|076|S|in diet and lifestyle, such as eating several small meals and||
7134|077|S|limiting activity, may help lessen some of these effects. If any||
7134|078|S|of these effects last or get worse, tell your doctor or||
7134|079|S|pharmacist promptly.||
7134|080|S|   Doxorubicin may give a reddish color to your urine, tears, and||
7134|081|S|sweat. This effect may start in the first hours after treatment||
7134|082|S|and may last up to several days. This is a normal effect of the||
7134|083|S|drug and should not be mistaken for blood in your urine.||
7134|084|S|   Temporary hair loss may occur. Normal hair growth should||
7134|085|S|return after treatment has ended.||
7134|086|S|   Nail changes (including fungal infections in the nail beds)||
7134|087|S|may rarely occur.||
7134|088|S|   Remember that this medication has been prescribed because your||
7134|089|S|doctor has judged that the benefit to you is greater than the||
7134|090|S|risk of side effects. Many people using this medication do not||
7134|091|S|have serious side effects.||
7134|092|S|   Tell your doctor right away if you have any serious side||
7134|093|S|effects, including: diarrhea that doesn't stop, symptoms of heart||
7134|094|S|failure (such as shortness of breath, swelling ankles/feet,||
7134|095|S|unusual tiredness, unusual/sudden weight gain), redness/flushing||
7134|096|S|of face, eye redness/itching, cough/hoarseness, joint pain, pain||
7134|097|S|in the lower back/side/stomach/abdomen, painful/difficult||
7134|098|S|urination, stopped/missed menstrual periods, black/tarry stools,||
7134|099|S|bloody mucus or discharge in stools, fast/irregular heartbeat,||
7134|100|S|dizziness, decreased urination.||
7134|101|S|   Painful sores on the lips, mouth and throat may occur. To||
7134|102|S|decrease the risk, limit hot foods and drinks, brush your teeth||
7134|103|S|carefully, avoid using mouthwash that contains alcohol, and rinse||
7134|104|S|your mouth often with cool water.||
7134|105|S|   Get medical help right away if you have any very serious side||
7134|106|S|effects, including: chest pain.||
7134|107|S|   Within days to weeks after doxorubicin treatment, a serious||
7134|108|S|skin reaction that looks likes a severe sunburn (radiation||
7134|109|S|recall) may develop on any area of skin that has been previously||
7134|110|S|treated with radiation. Also, doxorubicin may make you more||
7134|111|S|sensitive to the sun. Limit your time in the sun. Avoid tanning||
7134|112|S|booths and sunlamps. Use sunscreen and wear protective clothing||
7134|113|S|when outdoors. Tell your doctor right away if you have skin||
7134|114|S|redness, pain, tenderness, swelling, peeling, blisters, or if you||
7134|115|S|get sunburned. Your doctor may prescribe medication to help your||
7134|116|S|skin heal faster and reduce the swelling.||
7134|117|S|   In children, radiation recall may occur in the lungs. Tell the||
7134|118|S|doctor right away if you notice wheezing or trouble breathing in||
7134|119|S|the child.||
7134|120|S|   A very serious allergic reaction to this drug is rare.||
7134|121|S|However, get medical help right away if you notice any symptoms||
7134|122|S|of a serious allergic reaction, including: rash, itching/swelling||
7134|123|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7134|124|S|breathing.||
7134|125|S|   This is not a complete list of possible side effects. If you||
7134|126|S|notice other effects not listed above, contact your doctor or||
7134|127|S|pharmacist.||
7134|128|S|   In the US -||
7134|129|S|   Call your doctor for medical advice about side effects. You||
7134|130|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7134|131|S|www.fda.gov/medwatch.||
7134|132|S|   In Canada - Call your doctor for medical advice about side||
7134|133|S|effects. You may report side effects to Health Canada at||
7134|134|S|1-866-234-2345.||
7134|135|B|||
7134|136|P|PRECAUTIONS:  See also Side Effects section.||
7134|137|P|   Before using doxorubicin, tell your doctor or pharmacist if||
7134|138|P|you are allergic to it; or to lincomycin; or if you have any||
7134|139|P|other allergies. This product may contain inactive ingredients,||
7134|140|P|which can cause allergic reactions or other problems. Talk to||
7134|141|P|your pharmacist for more details.||
7134|142|P|   Before using this medication, tell your doctor or pharmacist||
7134|143|P|your medical history, especially of: a current infection, low||
7134|144|P|blood cell counts (such as anemia, neutropenia,||
7134|145|P|thrombocytopenia), gout, heart problems (such as recent heart||
7134|146|P|attack, heart failure, irregular heartbeat), a history of||
7134|147|P|receiving any anthracycline-type drug (such as doxorubicin,||
7134|148|P|idarubicin, daunorubicin, mitoxantrone), kidney problems, liver||
7134|149|P|disease, severe mouth sores (stomatitis), radiation treatment||
7134|150|P|(especially to the chest area).||
7134|151|P|   Doxorubicin can make you more likely to get infections or may||
7134|152|P|make current infections worse. Stay away from anyone who has an||
7134|153|P|infection that may easily spread (such as chickenpox, COVID-19,||
7134|154|P|measles, flu). Talk to your doctor if you have been exposed to an||
7134|155|P|infection or for more details.||
7134|156|P|   Tell your health care professional that you are using||
7134|157|P|doxorubicin before having any immunizations/vaccinations. Avoid||
7134|158|P|contact with people who have recently received live vaccines||
7134|159|P|(such as flu vaccine inhaled through the nose).||
7134|160|P|   To lower the chance of getting cut, bruised, or injured, use||
7134|161|P|caution with sharp objects like safety razors and nail cutters,||
7134|162|P|and avoid activities such as contact sports. Use a soft-bristle||
7134|163|P|toothbrush to lower the risk of bleeding gums.||
7134|164|P|   Children may be more sensitive to the side effects of this||
7134|165|P|drug, especially to radiation recall in the lungs, heart||
7134|166|P|problems, or another cancer later on in life. Doxorubicin, in||
7134|167|P|combination with other chemotherapies, may also slow the growth||
7134|168|P|of children before puberty.||
7134|169|P|   This medication can affect fertility in males. It can also||
7134|170|P|affect menstruation in females and cause premature menopause. Ask||
7134|171|P|your doctor for more details.||
7134|172|P|   Tell your doctor if you are pregnant or plan to become||
7134|173|P|pregnant. You should not become pregnant while using doxorubicin.||
7134|174|P|Doxorubicin may harm an unborn baby. Your doctor should order a||
7134|175|P|pregnancy test before you start this medication. Women using this||
7134|176|P|medication should ask about reliable forms of birth control||
7134|177|P|during treatment and for at least 6 months after the last dose.||
7134|178|P|Men using this medication should ask about reliable forms of||
7134|179|P|birth control during treatment and for at least 3 months after||
7134|180|P|the last dose. Men who have a pregnant partner must use a condom||
7134|181|P|during sex while on treatment with doxorubicin and for 10 days||
7134|182|P|after the last dose. If you or your partner becomes pregnant,||
7134|183|P|talk to your doctor right away about the risks and benefits of||
7134|184|P|this medication.||
7134|185|P|   This medication passes into breast milk. Because of the||
7134|186|P|possible risk to the infant, breastfeeding is not recommended||
7134|187|P|while using this medication and for 10 days after the last dose.||
7134|188|P|Consult your doctor before breastfeeding.||
7134|189|B|||
7134|190|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7134|191|I|medications work or increase your risk for serious side effects.||
7134|192|I|This document does not contain all possible drug interactions.||
7134|193|I|Keep a list of all the products you use (including||
7134|194|I|prescription/nonprescription drugs and herbal products) and share||
7134|195|I|it with your doctor and pharmacist. Do not start, stop, or change||
7134|196|I|the dosage of any medicines without your doctor's approval.||
7134|197|I|   Some products that may interact with this drug include:||
7134|198|I|digoxin, progesterone, streptozocin, stavudine, trastuzumab,||
7134|199|I|zidovudine.||
7134|200|I|   Other medications can affect the removal of doxorubicin from||
7134|201|I|your body, which may affect how doxorubicin works. Examples||
7134|202|I|include azole antifungals (such as ketoconazole), calcium channel||
7134|203|I|blockers (such as verapamil, nifedipine), rifamycins (such as||
7134|204|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
7134|205|I|as carbamazepine, phenytoin, phenobarbital, primidone), among||
7134|206|I|others.||
7134|207|I|   Avoid eating foods or products containing turmeric (curcumin)||
7134|208|I|while taking doxorubicin. It may decrease doxorubicin's effects.||
7134|209|I|Consult your doctor or pharmacist for more details.||
7134|210|B|||
7134|211|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7134|212|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7134|213|O|poison control center right away. US residents can call||
7134|214|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7134|215|O|Symptoms of overdose may include: seizures, unexplained bleeding.||
7134|216|B|||
7134|217|N|NOTES:  Lab and/or medical tests (such as blood mineral levels,||
7134|218|N|complete blood counts, heart/liver function) should be done while||
7134|219|N|you are using this medication. Keep all medical and lab||
7134|220|N|appointments. Consult your doctor for more details.||
7134|221|B|||
7134|222|D|MISSED DOSE:  It is important to get each dose of this medication||
7134|223|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7134|224|D|right away for a new dosing schedule.||
7134|225|B|||
7134|226|R|STORAGE:  Consult the product instructions and your pharmacist||
7134|227|R|for storage details. Keep all medications away from children and||
7134|228|R|pets.||
7134|229|R|   Do not flush medications down the toilet or pour them into a||
7134|230|R|drain unless instructed to do so. Properly discard this product||
7134|231|R|when it is expired or no longer needed. Consult your pharmacist||
7134|232|R|or local waste disposal company.||
7134|233|B|||
7134|234|M|MEDICAL ALERT:  Your condition can cause complications in a||
7134|235|M|medical emergency. For information about enrolling in MedicAlert,||
7134|236|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7134|237|B|||
7134|238|A|Information last revised June 2024.||
7134|239|A|Copyright(c) 2025 First Databank, Inc.||
7134|240|B|||
7135|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7135|002|Z|does NOT have all possible information about this product. This||
7135|003|Z|information does not assure that this product is safe, effective,||
7135|004|Z|or appropriate for you. This information is not individual||
7135|005|Z|medical advice and does not substitute for the advice of your||
7135|006|Z|health care professional. Always ask your health care||
7135|007|Z|professional for complete information about this product and your||
7135|008|Z|specific health needs.||
7135|009|B|||
7135|010|T|CYCLOPHOSPHAMIDE - ORAL||
7135|011|F|(sye-klo-FOSS-fuh-mide)||
7135|012|B|||
7135|013|C|COMMON BRAND NAME(S): Cytoxan||
7135|014|B|||
7135|015|U|USES:  Cyclophosphamide is used to treat various types of cancer.||
7135|016|U|It is a chemotherapy drug that works by slowing or stopping cell||
7135|017|U|growth.||
7135|018|U|   Cyclophosphamide also works by decreasing your immune system's||
7135|019|U|response to various diseases. It is used to treat a certain type||
7135|020|U|of kidney disease in children after other treatments have not||
7135|021|U|worked.||
7135|022|B|||
7135|023|V|OTHER USES:  This section contains uses of this drug that are not||
7135|024|V|listed in the approved professional labeling for the drug but||
7135|025|V|that may be prescribed by your health care professional. Use this||
7135|026|V|drug for a condition that is listed in this section only if it||
7135|027|V|has been so prescribed by your health care professional.||
7135|028|V|   This medication may also be used for various conditions such||
7135|029|V|as lupus and multiple sclerosis.||
7135|030|B|||
7135|031|H|HOW TO USE:  Take this medication by mouth exactly as directed by||
7135|032|H|your doctor. The dosage is based on your medical condition,||
7135|033|H|weight, response to treatment, and other treatments (such as||
7135|034|H|other chemotherapy drugs, radiation) you may be receiving. Be||
7135|035|H|sure to tell your doctor and pharmacist about all the products||
7135|036|H|you use (including prescription drugs, nonprescription drugs, and||
7135|037|H|herbal products).||
7135|038|H|   During treatment with this medication, you must drink more||
7135|039|H|fluids than usual and pass urine often to help avoid kidney and||
7135|040|H|bladder side effects. Ask your doctor how much you should drink||
7135|041|H|and how often to empty your bladder each day, and follow these||
7135|042|H|instructions carefully.||
7135|043|H|   Swallow the tablets/capsules whole. Do not chew or crush the||
7135|044|H|tablets/capsules. Do not open the capsules. If you have||
7135|045|H|accidental contact with broken tablets/capsules, wash your hands||
7135|046|H|thoroughly right away.||
7135|047|H|   Since this drug can be absorbed through the skin and lungs and||
7135|048|H|may harm an unborn baby, women who are pregnant or who may become||
7135|049|H|pregnant should not handle this medication or breathe dust from||
7135|050|H|the tablets or capsules.||
7135|051|H|   Do not increase your dose or take this medication more often||
7135|052|H|without your doctor's approval. Your condition will not improve||
7135|053|H|any faster and the risk of serious side effects may be increased.||
7135|054|B|||
7135|055|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, stomach ache,||
7135|056|S|diarrhea, or darkening of the skin/nails may occur. Nausea and||
7135|057|S|vomiting can be severe. In some cases, drug therapy may be||
7135|058|S|necessary to prevent or relieve nausea and vomiting. Changes in||
7135|059|S|diet such as eating several small meals or limiting activity may||
7135|060|S|help lessen some of these effects. If any of these effects last||
7135|061|S|or get worse, tell your doctor or pharmacist promptly.||
7135|062|S|   Temporary hair loss may occur. Hair growth should return after||
7135|063|S|treatment has ended or may even return during treatment. However,||
7135|064|S|new hair may have a different color or texture.||
7135|065|S|   People using this medication may have serious side effects.||
7135|066|S|However, you have been prescribed this drug because your doctor||
7135|067|S|has judged that the benefit to you is greater than the risk of||
7135|068|S|side effects. Careful monitoring by your doctor may decrease your||
7135|069|S|risk.||
7135|070|S|   Tell your doctor right away if you have any serious side||
7135|071|S|effects, including: signs of kidney or bladder problems (such as||
7135|072|S|change in the amount of urine, pink/bloody urine), mouth sores,||
7135|073|S|joint pain, stopping of menstrual periods, existing wounds that||
7135|074|S|are slow healing, black/bloody stools, signs of liver problems||
7135|075|S|(such as stomach/abdominal pain, yellowing eyes/skin, dark||
7135|076|S|urine), mental/mood changes, muscle weakness/spasm.||
7135|077|S|   This medication may rarely cause very serious effects on the||
7135|078|S|heart, especially when used in high doses, or in combination with||
7135|079|S|radiation treatment or certain other chemotherapy drugs (such as||
7135|080|S|doxorubicin). Get medical help right away if you develop: chest||
7135|081|S|pain, jaw/left arm pain, trouble breathing, irregular heartbeat,||
7135|082|S|symptoms of heart failure (such as shortness of breath, swelling||
7135|083|S|ankles/feet, unusual tiredness, unusual/sudden weight gain).||
7135|084|S|   This medication decreases bone marrow function, an effect that||
7135|085|S|may lead to a low number of blood cells such as red cells, white||
7135|086|S|cells, and platelets. This effect can cause anemia, decrease your||
7135|087|S|body's ability to fight an infection, or cause easy||
7135|088|S|bruising/bleeding. Tell your doctor right away if you develop any||
7135|089|S|of the following symptoms: unusual tiredness, pale skin, signs of||
7135|090|S|infection (such as sore throat that doesn't go away, fever,||
7135|091|S|chills), easy bruising/bleeding.||
7135|092|S|   Cyclophosphamide may lessen the chance of having children in||
7135|093|S|both men and women. Sterility is usually temporary with this||
7135|094|S|medication, but can be permanent in some cases. Consult your||
7135|095|S|doctor for more details.||
7135|096|S|   Although cyclophosphamide is used to treat cancer, in some||
7135|097|S|patients it may increase the risk of developing another form of||
7135|098|S|cancer, sometimes months to years after treatment. Consult your||
7135|099|S|doctor for more details. It is important to be closely monitored||
7135|100|S|by your doctor during treatment. You should also see your doctor||
7135|101|S|regularly after treatment is finished. Tell your doctor right||
7135|102|S|away if you develop: unusual growths or lumps, swollen lymph||
7135|103|S|nodes, unexplained or sudden weight loss, night sweats, pain in||
7135|104|S|the pelvis, painful or frequent urination.||
7135|105|S|   A very serious allergic reaction to this drug is rare.||
7135|106|S|However, get medical help right away if you notice any symptoms||
7135|107|S|of a serious allergic reaction, including: rash, itching/swelling||
7135|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7135|109|S|breathing.||
7135|110|S|   This is not a complete list of possible side effects. If you||
7135|111|S|notice other effects not listed above, contact your doctor or||
7135|112|S|pharmacist.||
7135|113|S|   In the US -||
7135|114|S|   Call your doctor for medical advice about side effects. You||
7135|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7135|116|S|www.fda.gov/medwatch.||
7135|117|S|   In Canada - Call your doctor for medical advice about side||
7135|118|S|effects. You may report side effects to Health Canada at||
7135|119|S|1-866-234-2345.||
7135|120|B|||
7135|121|P|PRECAUTIONS:  Before taking cyclophosphamide, tell your doctor or||
7135|122|P|pharmacist if you are allergic to it; or to other chemotherapy||
7135|123|P|drugs (such as busulfan, chlorambucil); or if you have any other||
7135|124|P|allergies. This product may contain inactive ingredients, which||
7135|125|P|can cause allergic reactions or other problems. Talk to your||
7135|126|P|pharmacist for more details.||
7135|127|P|   Before using this medication, tell your doctor or pharmacist||
7135|128|P|your medical history, especially of: decreased bone marrow||
7135|129|P|function (such as anemia, leukopenia, thrombocytopenia), liver||
7135|130|P|disease, kidney disease, difficulty urinating (for example, due||
7135|131|P|to blockage), surgery to remove your adrenal glands.||
7135|132|P|   Cyclophosphamide can make you more likely to get infections or||
7135|133|P|may make current infections worse. Stay away from anyone who has||
7135|134|P|an infection that may easily spread (such as chickenpox,||
7135|135|P|COVID-19, measles, flu). Talk to your doctor if you have been||
7135|136|P|exposed to an infection or for more details.||
7135|137|P|   Tell your health care professional that you are using||
7135|138|P|cyclophosphamide before having any immunizations/vaccinations.||
7135|139|P|Avoid contact with people who have recently received live||
7135|140|P|vaccines (such as flu vaccine inhaled through the nose).||
7135|141|P|   To lower the chance of getting cut, bruised, or injured, use||
7135|142|P|caution with sharp objects like razors and nail cutters, and||
7135|143|P|avoid activities such as contact sports.||
7135|144|P|   Before having surgery, tell your doctor or dentist about all||
7135|145|P|the products you use (including prescription drugs,||
7135|146|P|nonprescription drugs, and herbal products).||
7135|147|P|   Children may be more sensitive to the side effects of this||
7135|148|P|drug, especially possible infertility later in life.||
7135|149|P|   Since this drug can be absorbed through the skin and lungs and||
7135|150|P|may harm an unborn baby, women who are pregnant or who may become||
7135|151|P|pregnant should not handle this medication or breathe dust from||
7135|152|P|the tablets or capsules.||
7135|153|P|   Tell your doctor if you are pregnant or plan to become||
7135|154|P|pregnant. You should not become pregnant while using||
7135|155|P|cyclophosphamide. Cyclophosphamide may harm an unborn baby. Your||
7135|156|P|doctor should order a pregnancy test before you start this||
7135|157|P|medication. Women using this medication should ask about reliable||
7135|158|P|forms of birth control during treatment and for 1 year after the||
7135|159|P|last dose. Men using this medication should ask about reliable||
7135|160|P|forms of birth control during treatment and for 4 months after||
7135|161|P|the last dose. If you or your partner becomes pregnant, talk to||
7135|162|P|your doctor right away about the risks and benefits of this||
7135|163|P|medication.||
7135|164|P|   This drug passes into breast milk and may harm a nursing||
7135|165|P|infant. Breastfeeding is not recommended while using this drug||
7135|166|P|and for 1 week after the last dose. Consult your doctor before||
7135|167|P|breastfeeding.||
7135|168|B|||
7135|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7135|170|I|medications work or increase your risk for serious side effects.||
7135|171|I|This document does not contain all possible drug interactions.||
7135|172|I|Keep a list of all the products you use (including||
7135|173|I|prescription/nonprescription drugs and herbal products) and share||
7135|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
7135|175|I|the dosage of any medicines without your doctor's approval.||
7135|176|I|   Some products that may interact with this drug include:||
7135|177|I|azathioprine, etanercept, turmeric (curcumin), voclosporin.||
7135|178|B|||
7135|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7135|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7135|181|O|poison control center right away. US residents can call||
7135|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7135|183|B|||
7135|184|N|NOTES:  Do not share this medication with others.||
7135|185|N|   Lab and/or medical tests (such as complete blood counts, urine||
7135|186|N|tests) should be done while you are taking this medication. Keep||
7135|187|N|all medical and lab appointments. Consult your doctor for more||
7135|188|N|details.||
7135|189|B|||
7135|190|D|MISSED DOSE:  It is important to take each dose of this||
7135|191|D|medication as scheduled. If you miss a dose, ask your doctor or||
7135|192|D|pharmacist right away for a new dosing schedule. Do not double||
7135|193|D|the dose to catch up.||
7135|194|B|||
7135|195|R|STORAGE:  Store the tablets and capsules at room temperature away||
7135|196|R|from light and moisture. Do not store in the bathroom. Store the||
7135|197|R|oral solution in the refrigerator. Discard any unused solution||
7135|198|R|after 14 days. Keep all medications away from children and pets.||
7135|199|R|   Do not flush medications down the toilet or pour them into a||
7135|200|R|drain unless instructed to do so. Properly discard this product||
7135|201|R|when it is expired or no longer needed. Consult your pharmacist||
7135|202|R|or local waste disposal company.||
7135|203|B|||
7135|204|M|MEDICAL ALERT:  Your condition can cause complications in a||
7135|205|M|medical emergency. For information about enrolling in MedicAlert,||
7135|206|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7135|207|B|||
7135|208|A|Information last revised May 2025.||
7135|209|A|Copyright(c) 2025 First Databank, Inc.||
7135|210|B|||
7143|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7143|002|Z|does NOT have all possible information about this product. This||
7143|003|Z|information does not assure that this product is safe, effective,||
7143|004|Z|or appropriate for you. This information is not individual||
7143|005|Z|medical advice and does not substitute for the advice of your||
7143|006|Z|health care professional. Always ask your health care||
7143|007|Z|professional for complete information about this product and your||
7143|008|Z|specific health needs.||
7143|009|B|||
7143|010|T|LANSOPRAZOLE/AMOXICILLIN/CLARITHROMYCIN - ORAL||
7143|011|F|(lan-SOE-pra-zole/a-MOX-i-SIL-in/kla-RITH-roe-MYE-sin)||
7143|012|B|||
7143|013|C|COMMON BRAND NAME(S): Prevpac||
7143|014|B|||
7143|015|U|USES:  This product is used to treat stomach/intestinal ulcers||
7143|016|U|caused by the bacteria H. pylori and to prevent the ulcers from||
7143|017|U|returning. Treating an ulcer reduces the risk of serious damage||
7143|018|U|to the lining of the stomach/intestines (such as bleeding,||
7143|019|U|tearing, blockage).||
7143|020|U|   Lansoprazole is known as a proton pump inhibitor (PPI). It||
7143|021|U|works by blocking acid production in the stomach. Decreasing||
7143|022|U|excess stomach acid can help the ulcer heal. Amoxicillin and||
7143|023|U|clarithromycin are antibiotics used to treat a wide variety of||
7143|024|U|bacterial infections (including H. pylori). Treating the||
7143|025|U|infection helps reduce the risk of the ulcer returning.||
7143|026|U|Amoxicillin is a penicillin-type antibiotic and clarithromycin is||
7143|027|U|a macrolide-type antibiotic. They work by stopping the growth of||
7143|028|U|bacteria.||
7143|029|U|   The antibiotics in this product treat only bacterial||
7143|030|U|infections. Antibiotics do not work for viral infections (such as||
7143|031|U|common cold, flu). Using any antibiotic when it is not needed can||
7143|032|U|cause it to not work for future infections.||
7143|033|U|   Lansoprazole is not recommended for use in children younger||
7143|034|U|than 1 year due to an increased risk of serious side effects. Ask||
7143|035|U|the doctor or pharmacist for details.||
7143|036|B|||
7143|037|H|HOW TO USE:  Take this medication by mouth exactly as directed by||
7143|038|H|your doctor, usually 1 dose (4 pills) twice daily before a meal.||
7143|039|H|Swallow the lansoprazole capsules whole. Do not crush or chew.||
7143|040|H|   Each packet contains both the morning and evening doses of||
7143|041|H|this medication (a 1-day supply). Consult your doctor or||
7143|042|H|pharmacist for instructions on the proper use of this product.||
7143|043|H|The dosage and length of treatment is based on your medical||
7143|044|H|condition and response to treatment.||
7143|045|H|   For the best effect, take this product at evenly spaced times.||
7143|046|H|To help you remember, take this product at the same times every||
7143|047|H|day. Continue to take this medication until the full prescribed||
7143|048|H|amount is finished, even if symptoms disappear after a few days.||
7143|049|H|Stopping the medication too early may result in a return of the||
7143|050|H|infection.||
7143|051|H|   Tell your doctor if your condition lasts or gets worse.||
7143|052|B|||
7143|053|S|SIDE EFFECTS:  Diarrhea, headache, nausea, vomiting, and abnormal||
7143|054|S|taste may occur. If any of these effects last or get worse, tell||
7143|055|S|your doctor or pharmacist promptly.||
7143|056|S|   Remember that this medication has been prescribed because your||
7143|057|S|doctor has judged that the benefit to you is greater than the||
7143|058|S|risk of side effects. Many people using this medication do not||
7143|059|S|have serious side effects.||
7143|060|S|   Tell your doctor right away if you have any serious side||
7143|061|S|effects, including: muscle weakness, signs of liver disease (such||
7143|062|S|as nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
7143|063|S|urine), easy bruising/bleeding, mental/mood changes (such as||
7143|064|S|agitation, confusion), signs of lupus (such as rash on nose and||
7143|065|S|cheeks, new or worsening joint pain), signs of kidney problems||
7143|066|S|(such as change in the amount of urine, pink/bloody urine).||
7143|067|S|   Get medical help right away if you have any very serious side||
7143|068|S|effects, including: severe dizziness, fainting, fast/irregular||
7143|069|S|heartbeat.||
7143|070|S|   This medication may rarely cause a severe intestinal condition||
7143|071|S|due to a bacteria called C. difficile. This condition may occur||
7143|072|S|during treatment or weeks to months after treatment has stopped.||
7143|073|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7143|074|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7143|075|S|stool.||
7143|076|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7143|077|S|products because they may make symptoms worse.||
7143|078|S|   Use of this medication for prolonged or repeated periods may||
7143|079|S|result in oral thrush or a new yeast infection. Contact your||
7143|080|S|doctor if you notice white patches in your mouth, a change in||
7143|081|S|vaginal discharge, or other new symptoms.||
7143|082|S|   A very serious allergic reaction to this drug is rare.||
7143|083|S|However, get medical help right away if you notice any symptoms||
7143|084|S|of a serious allergic reaction, including: fever, swollen lymph||
7143|085|S|nodes, rash, itching/swelling (especially of the||
7143|086|S|face/tongue/throat), severe dizziness, trouble breathing.||
7143|087|S|   Amoxicillin can commonly cause a mild rash that is usually not||
7143|088|S|serious. However, you may not be able to tell it apart from a||
7143|089|S|rare rash that could be a sign of a severe allergic reaction. Get||
7143|090|S|medical help right away if you develop any rash.||
7143|091|S|   This is not a complete list of possible side effects. If you||
7143|092|S|notice other effects not listed above, contact your doctor or||
7143|093|S|pharmacist.||
7143|094|S|   In the US -||
7143|095|S|   Call your doctor for medical advice about side effects. You||
7143|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7143|097|S|www.fda.gov/medwatch.||
7143|098|S|   In Canada - Call your doctor for medical advice about side||
7143|099|S|effects. You may report side effects to Health Canada at||
7143|100|S|1-866-234-2345.||
7143|101|B|||
7143|102|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
7143|103|P|pharmacist if you are allergic to lansoprazole, amoxicillin, or||
7143|104|P|clarithromycin; or to penicillins (such as ampicillin),||
7143|105|P|cephalosporins (such as cephalexin), or macrolide antibiotics||
7143|106|P|(such as erythromycin); or to dexlansoprazole; or if you have any||
7143|107|P|other allergies. This product may contain inactive ingredients,||
7143|108|P|which can cause allergic reactions or other problems. Talk to||
7143|109|P|your pharmacist for more details.||
7143|110|P|   Before using this medication, tell your doctor or pharmacist||
7143|111|P|your medical history, especially of: liver disease (including||
7143|112|P|liver problems with past clarithromycin use), kidney disease,||
7143|113|P|heart disease (coronary artery disease, heart attack), a certain||
7143|114|P|type of muscle disease (myasthenia gravis), a certain type of||
7143|115|P|viral infection (infectious mononucleosis), lupus.||
7143|116|P|   Some symptoms may actually be signs of a more serious||
7143|117|P|condition. Get medical help right away if you have: heartburn||
7143|118|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
7143|119|P|pain (especially with shortness of breath, unusual sweating),||
7143|120|P|unexplained weight loss.||
7143|121|P|   Clarithromycin may cause a condition that affects the heart||
7143|122|P|rhythm (QT prolongation). QT prolongation can rarely cause||
7143|123|P|serious (rarely fatal) fast/irregular heartbeat and other||
7143|124|P|symptoms (such as severe dizziness, fainting) that need medical||
7143|125|P|attention right away.||
7143|126|P|   The risk of QT prolongation may be increased if you have||
7143|127|P|certain medical conditions or are taking other drugs that may||
7143|128|P|cause QT prolongation. Before using this product, tell your||
7143|129|P|doctor or pharmacist of all the drugs you take and if you have||
7143|130|P|any of the following conditions: certain heart problems (heart||
7143|131|P|failure, slow heartbeat, QT prolongation in the EKG), family||
7143|132|P|history of certain heart problems (QT prolongation in the EKG,||
7143|133|P|sudden cardiac death).||
7143|134|P|   Low levels of potassium or magnesium in the blood may also||
7143|135|P|increase your risk of QT prolongation. This risk may increase if||
7143|136|P|you use certain drugs (such as diuretics/"water pills") or if you||
7143|137|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7143|138|P|Talk to your doctor about using this product safely.||
7143|139|P|   This medication may cause live bacterial vaccines (such as||
7143|140|P|typhoid vaccine) to not work well. Tell your health care||
7143|141|P|professional that you are using this medication before having any||
7143|142|P|immunizations/vaccinations.||
7143|143|P|   Before having surgery, tell your doctor or dentist about all||
7143|144|P|the products you use (including prescription drugs,||
7143|145|P|nonprescription drugs, and herbal products).||
7143|146|P|   Older adults may be more sensitive to the side effects of this||
7143|147|P|drug, especially QT prolongation (see above), and C. difficile||
7143|148|P|infection (see Side Effects section).||
7143|149|P|   During pregnancy, this product should be used only when||
7143|150|P|clearly needed. Discuss the risks and benefits with your doctor.||
7143|151|P|   Amoxicillin and clarithromycin pass into breast milk. It is||
7143|152|P|unknown if lansoprazole passes into breast milk. Consult your||
7143|153|P|doctor before breastfeeding.||
7143|154|B|||
7143|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7143|156|I|medications work or increase your risk for serious side effects.||
7143|157|I|This document does not contain all possible drug interactions.||
7143|158|I|Keep a list of all the products you use (including||
7143|159|I|prescription/nonprescription drugs and herbal products) and share||
7143|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
7143|161|I|the dosage of any medicines without your doctor's approval.||
7143|162|I|   A product that may interact with this drug is: methotrexate.||
7143|163|I|   Many drugs besides clarithromycin may affect the heart rhythm||
7143|164|I|(QT prolongation), including amiodarone, disopyramide,||
7143|165|I|dofetilide, pacritinib, pimozide, procainamide, quinidine,||
7143|166|I|sotalol, among others.||
7143|167|I|   Other medications can affect the removal of clarithromycin||
7143|168|I|from your body, which may affect how clarithromycin works.||
7143|169|I|Examples include rifamycins (such as rifabutin), efavirenz,||
7143|170|I|nevirapine, among others.||
7143|171|I|   Clarithromycin can slow down the removal of other medications||
7143|172|I|from your body, which may affect how they work. Examples of||
7143|173|I|affected drugs include colchicine, digoxin, some drugs used to||
7143|174|I|treat erectile dysfunction-ED/pulmonary hypertension (such as||
7143|175|I|sildenafil, tadalafil), ergot alkaloids (such as ergotamine,||
7143|176|I|dihydroergotamine), flibanserin, some statin drugs (such as||
7143|177|I|lovastatin, simvastatin), tamsulosin, tolvaptan, ticagrelor,||
7143|178|I|among others.||
7143|179|I|   Some products need stomach acid so that the body can absorb||
7143|180|I|them properly. Lansoprazole decreases stomach acid, so it may||
7143|181|I|change how well these other products work. Some affected products||
7143|182|I|include atazanavir, erlotinib, levoketoconazole, nelfinavir,||
7143|183|I|pazopanib, rilpivirine, sparsentan, certain azole antifungals||
7143|184|I|(itraconazole, ketoconazole, posaconazole), among others. Before||
7143|185|I|using lansoprazole, consult your doctor or pharmacist about the||
7143|186|I|other medications you take and for advice on how to reduce or||
7143|187|I|avoid these types of interactions.||
7143|188|I|   Lansoprazole is very similar to dexlansoprazole. Do not use||
7143|189|I|medications containing dexlansoprazole while using lansoprazole.||
7143|190|I|   This medication may interfere with certain lab tests (such as||
7143|191|I|urine glucose test), possibly causing false test results. Make||
7143|192|I|sure lab personnel and all your doctors know you use this drug.||
7143|193|B|||
7143|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7143|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7143|196|O|poison control center right away. US residents can call||
7143|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7143|198|O|Symptoms of overdose may include: change in the amount of urine.||
7143|199|B|||
7143|200|N|NOTES:  Do not share this medication with others.||
7143|201|N|   This medication has been prescribed for your current condition||
7143|202|N|only. Do not use it later for another infection unless your||
7143|203|N|doctor tells you to.||
7143|204|N|   Lab and/or medical tests may be done while you are taking this||
7143|205|N|medication. Keep all medical and lab appointments. Consult your||
7143|206|N|doctor for more details.||
7143|207|B|||
7143|208|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7143|209|D|If it is near the time of the next dose, skip the missed dose.||
7143|210|D|Use your next dose at the regular time. Do not double the dose to||
7143|211|D|catch up.||
7143|212|B|||
7143|213|R|STORAGE:  Store at room temperature away from light and moisture.||
7143|214|R|Do not store in the bathroom. Keep all medications away from||
7143|215|R|children and pets.||
7143|216|R|   Do not flush medications down the toilet or pour them into a||
7143|217|R|drain unless instructed to do so. Properly discard this product||
7143|218|R|when it is expired or no longer needed. Consult your pharmacist||
7143|219|R|or local waste disposal company.||
7143|220|B|||
7143|221|A|Information last revised July 2024.||
7143|222|A|Copyright(c) 2025 First Databank, Inc.||
7143|223|B|||
7146|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7146|002|Z|does NOT have all possible information about this product. This||
7146|003|Z|information does not assure that this product is safe, effective,||
7146|004|Z|or appropriate for you. This information is not individual||
7146|005|Z|medical advice and does not substitute for the advice of your||
7146|006|Z|health care professional. Always ask your health care||
7146|007|Z|professional for complete information about this product and your||
7146|008|Z|specific health needs.||
7146|009|B|||
7146|010|T|MESALAMINE (5-AMINOSALICYLIC ACID) ENEMA - RECTAL||
7146|011|F|(me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id)||
7146|012|B|||
7146|013|C|COMMON BRAND NAME(S): Rowasa||
7146|014|B|||
7146|015|U|USES:  Mesalamine (also known as 5-aminosalicylic acid) is used||
7146|016|U|to treat certain types of bowel disease (distal ulcerative||
7146|017|U|colitis, proctosigmoiditis, proctitis). It does not cure these||
7146|018|U|conditions, but it may relieve mild-to-moderate pain and decrease||
7146|019|U|the frequency of diarrhea/bloody stools caused by||
7146|020|U|irritation/swelling in the colon/rectum. Mesalamine is an||
7146|021|U|aminosalicylate anti-inflammatory drug. It is believed to work by||
7146|022|U|blocking the production of certain natural chemicals that may||
7146|023|U|cause pain and swelling.||
7146|024|B|||
7146|025|V|OTHER USES:  This section contains uses of this drug that are not||
7146|026|V|listed in the approved professional labeling for the drug but||
7146|027|V|that may be prescribed by your health care professional. Use this||
7146|028|V|drug for a condition that is listed in this section only if it||
7146|029|V|has been so prescribed by your health care professional.||
7146|030|V|   This drug may also be used for Crohn's disease.||
7146|031|B|||
7146|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7146|033|H|from your pharmacist before you start using mesalamine and each||
7146|034|H|time you get a refill. If you have any questions, ask your doctor||
7146|035|H|or pharmacist.||
7146|036|H|   Use this medication rectally as directed by your doctor,||
7146|037|H|usually once daily at bedtime. The dosage is based on your||
7146|038|H|medical condition and response to treatment.||
7146|039|H|   Drink plenty of fluids during treatment with this medication||
7146|040|H|unless otherwise directed by your doctor. This will help prevent||
7146|041|H|kidney stones.||
7146|042|H|   Before using, check this product for discoloration. The||
7146|043|H|medication should be off-white to tan in color. A slight||
7146|044|H|darkening of the medication is normal, but if the medication||
7146|045|H|turns dark brown, do not use the enema.||
7146|046|H|   This medication works best if you have a bowel movement before||
7146|047|H|using it. Shake the bottle well. Holding the bottle at the neck,||
7146|048|H|remove the cover from the applicator tip. Lie on your left side||
7146|049|H|with your right knee bent. Insert the tip of the bottle into the||
7146|050|H|rectum, pointing toward the navel. Gently and steadily squeeze||
7146|051|H|out the entire contents of the bottle. Remove the bottle. Remain||
7146|052|H|in position for 30 minutes. Throw away the empty bottle. Try to||
7146|053|H|keep the medication in the rectum for 8 hours.||
7146|054|H|   This medication may stain surfaces that it touches (such as||
7146|055|H|clothing, floor, and counter surfaces).||
7146|056|H|   Use this medication regularly in order to get the most benefit||
7146|057|H|from it. To help you remember, use it at the same time each day.||
7146|058|H|   Tell your doctor if your condition lasts or gets worse.||
7146|059|B|||
7146|060|S|SIDE EFFECTS:  Rectal pain, pain while inserting the bottle tip,||
7146|061|S|gas, and joint/leg pain may occur. If any of these effects last||
7146|062|S|or get worse, tell your doctor or pharmacist promptly.||
7146|063|S|   Remember that this medication has been prescribed because your||
7146|064|S|doctor has judged that the benefit to you is greater than the||
7146|065|S|risk of side effects. Many people using this medication do not||
7146|066|S|have serious side effects.||
7146|067|S|   Rarely, this medication may make symptoms of your condition||
7146|068|S|worse rather than better (acute intolerance syndrome or||
7146|069|S|sensitivity reaction). Tell your doctor right away if you||
7146|070|S|experience any of these unlikely but serious side effects:||
7146|071|S|worsening stomach pain/cramping, worsening bloody diarrhea,||
7146|072|S|severe/prolonged headache.||
7146|073|S|   Tell your doctor right away if you have any serious side||
7146|074|S|effects, including: chest pain, shortness of breath, severe||
7146|075|S|stomach/abdominal pain (especially if spreading to the back),||
7146|076|S|yellowing eyes/skin, dark urine, signs of kidney problems (such||
7146|077|S|as change in the amount of urine, blood in the urine).||
7146|078|S|   A very serious allergic reaction to this drug is rare.||
7146|079|S|However, get medical help right away if you notice any symptoms||
7146|080|S|of a serious allergic reaction, including: fever, swollen lymph||
7146|081|S|nodes, rash, itching/swelling (especially of the||
7146|082|S|face/tongue/throat), severe dizziness, trouble breathing.||
7146|083|S|   This is not a complete list of possible side effects. If you||
7146|084|S|notice other effects not listed above, contact your doctor or||
7146|085|S|pharmacist.||
7146|086|S|   In the US -||
7146|087|S|   Call your doctor for medical advice about side effects. You||
7146|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7146|089|S|www.fda.gov/medwatch.||
7146|090|S|   In Canada - Call your doctor for medical advice about side||
7146|091|S|effects. You may report side effects to Health Canada at||
7146|092|S|1-866-234-2345.||
7146|093|B|||
7146|094|P|PRECAUTIONS:  Before using mesalamine, tell your doctor or||
7146|095|P|pharmacist if you are allergic to it; or to other||
7146|096|P|aminosalicylates (such as balsalazide, olsalazine); or to||
7146|097|P|salicylates (such as aspirin, salsalate); or to sulfasalazine; or||
7146|098|P|if you have any other allergies. This product may contain||
7146|099|P|inactive ingredients (such as sulfites), which can cause allergic||
7146|100|P|reactions or other problems. Talk to your pharmacist for more||
7146|101|P|details.||
7146|102|P|   Before using this medication, tell your doctor or pharmacist||
7146|103|P|your medical history, especially of: asthma, kidney problems,||
7146|104|P|liver disease, pancreas problems (pancreatitis), inflammation of||
7146|105|P|the sac around the heart (pericarditis).||
7146|106|P|   This medication may make you more sensitive to the sun,||
7146|107|P|especially if you have skin problems (such as atopic dermatitis,||
7146|108|P|eczema). Limit your time in the sun. Avoid tanning booths and||
7146|109|P|sunlamps. Use sunscreen and wear protective clothing when||
7146|110|P|outdoors. Tell your doctor right away if you get sunburned or||
7146|111|P|have skin blisters/redness.||
7146|112|P|   Before having surgery, tell your doctor or dentist about all||
7146|113|P|the products you use (including prescription drugs,||
7146|114|P|nonprescription drugs, and herbal products).||
7146|115|P|   This medication is similar to aspirin. Children and teenagers||
7146|116|P|younger than 18 years should not take aspirin or aspirin-related||
7146|117|P|medications (such as salicylates) if they have chickenpox, flu,||
7146|118|P|or any undiagnosed illness, or if they have just been given a||
7146|119|P|live virus vaccine (such as varicella vaccine), without first||
7146|120|P|consulting a doctor about Reye's syndrome, a rare but serious||
7146|121|P|illness.||
7146|122|P|   During pregnancy, this medication should be used only when||
7146|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
7146|124|P|   This medication passes into breast milk and may have||
7146|125|P|undesirable effects on a nursing infant. Consult your doctor||
7146|126|P|before breastfeeding.||
7146|127|B|||
7146|128|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7146|129|I|medications work or increase your risk for serious side effects.||
7146|130|I|This document does not contain all possible drug interactions.||
7146|131|I|Keep a list of all the products you use (including||
7146|132|I|prescription/nonprescription drugs and herbal products) and share||
7146|133|I|it with your doctor and pharmacist. Do not start, stop, or change||
7146|134|I|the dosage of any medicines without your doctor's approval.||
7146|135|I|   This medication may interfere with certain lab tests (such as||
7146|136|I|urine normetanephrine levels), possibly causing false test||
7146|137|I|results. Make sure lab personnel and all your doctors know you||
7146|138|I|use this drug.||
7146|139|B|||
7146|140|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7146|141|O|has overdosed and has serious symptoms such as passing out or||
7146|142|O|trouble breathing, call 911. Otherwise, call a poison control||
7146|143|O|center right away. US residents can call 1-800-222-1222. Canada||
7146|144|O|residents can call 1-844-764-7669.||
7146|145|B|||
7146|146|N|NOTES:  Do not share this medication with others.||
7146|147|N|   Lab and/or medical tests (such as liver/kidney function) may||
7146|148|N|be done before you start using this medication and while you are||
7146|149|N|using it. Keep all medical and lab appointments. Consult your||
7146|150|N|doctor for more details.||
7146|151|B|||
7146|152|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7146|153|D|If it is near the time of the next dose, skip the missed dose.||
7146|154|D|Use your next dose at the regular time. Do not double the dose to||
7146|155|D|catch up.||
7146|156|B|||
7146|157|R|STORAGE:  Store at room temperature. Keep the enemas in the foil||
7146|158|R|pouch until ready to use. Keep all medications away from children||
7146|159|R|and pets.||
7146|160|R|   Do not flush medications down the toilet or pour them into a||
7146|161|R|drain unless instructed to do so. Properly discard this product||
7146|162|R|when it is expired or no longer needed. Consult your pharmacist||
7146|163|R|or local waste disposal company.||
7146|164|B|||
7146|165|A|Information last revised November 2024.||
7146|166|A|Copyright(c) 2025 First Databank, Inc.||
7146|167|B|||
7152|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7152|002|Z|does NOT have all possible information about this product. This||
7152|003|Z|information does not assure that this product is safe, effective,||
7152|004|Z|or appropriate for you. This information is not individual||
7152|005|Z|medical advice and does not substitute for the advice of your||
7152|006|Z|health care professional. Always ask your health care||
7152|007|Z|professional for complete information about this product and your||
7152|008|Z|specific health needs.||
7152|009|B|||
7152|010|T|OXYBUTYNIN EXTENDED-RELEASE - ORAL||
7152|011|F|(OX-i-BUE-ti-nin)||
7152|012|B|||
7152|013|C|COMMON BRAND NAME(S): Ditropan XL||
7152|014|B|||
7152|015|U|USES:  This is a long-acting form of oxybutynin that is used to||
7152|016|U|treat overactive bladder and urinary conditions. It relaxes the||
7152|017|U|muscles in the bladder to help decrease problems of urgency and||
7152|018|U|frequent urination. Oxybutynin belongs to a class of drugs known||
7152|019|U|as antispasmodics.||
7152|020|U|   This medication is also used to treat children 6 years of age||
7152|021|U|and older who have an overactive bladder due to certain nerve||
7152|022|U|disorders (such as spina bifida).||
7152|023|B|||
7152|024|H|HOW TO USE:  Take this medication by mouth with or without food||
7152|025|H|as directed by your doctor, usually once a day. The dosage is||
7152|026|H|based on your medical condition and response to treatment. The||
7152|027|H|length of treatment is determined by your doctor who may suggest||
7152|028|H|periodic trials off the drug to evaluate whether you still need||
7152|029|H|to be taking it.||
7152|030|H|   Swallow this medication with the help of liquids. Swallow the||
7152|031|H|tablets whole. Do not crush or chew the tablets. Doing so can||
7152|032|H|release all of the drug at once, increasing the risk of side||
7152|033|H|effects.||
7152|034|H|   Use this medication regularly in order to get the most benefit||
7152|035|H|from it. Remember to use it at the same time each day.||
7152|036|H|   Tell your doctor if your condition lasts or gets worse.||
7152|037|B|||
7152|038|S|SIDE EFFECTS:  Dry mouth, drowsiness, headache, dizziness,||
7152|039|S|nausea, vomiting, upset stomach, stomach pain, constipation,||
7152|040|S|diarrhea, blurred vision, dry eyes, unusual taste in mouth,||
7152|041|S|dry/flushed skin, stuffy nose, and cough may occur. If any of||
7152|042|S|these effects last or get worse, tell your doctor or pharmacist||
7152|043|S|promptly.||
7152|044|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
7152|045|S|chips, chew (sugarless) gum, drink water or use a saliva||
7152|046|S|substitute. To relieve dry eyes, use artificial tears or other||
7152|047|S|eye lubricants. Consult your pharmacist for further advice.||
7152|048|S|   To prevent constipation, eat dietary fiber, drink enough||
7152|049|S|water, and exercise. You may also need to take a laxative. Ask||
7152|050|S|your pharmacist which type of laxative is right for you.||
7152|051|S|   For certain products of this drug, an empty tablet shell may||
7152|052|S|appear in your stool. This is harmless.||
7152|053|S|   Remember that this medication has been prescribed because your||
7152|054|S|doctor has judged that the benefit to you is greater than the||
7152|055|S|risk of side effects. Many people using this medication do not||
7152|056|S|have serious side effects.||
7152|057|S|   Tell your doctor right away if you have any serious side||
7152|058|S|effects, including: decreased sexual activity, difficulty||
7152|059|S|urinating, fast/pounding heartbeat, signs of kidney infection||
7152|060|S|(such as burning/painful/frequent urination, lower back pain,||
7152|061|S|fever), mental/mood changes (such as confusion, hallucinations),||
7152|062|S|swelling of arms/legs/ankles/feet, vision problems (including eye||
7152|063|S|pain), seizures, stomach/intestinal blockage (such as||
7152|064|S|nausea/vomiting that doesn't stop, prolonged constipation).||
7152|065|S|   A very serious allergic reaction to this drug is rare.||
7152|066|S|However, get medical help right away if you notice any symptoms||
7152|067|S|of a serious allergic reaction, including: rash, itching/swelling||
7152|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7152|069|S|breathing.||
7152|070|S|   This is not a complete list of possible side effects. If you||
7152|071|S|notice other effects not listed above, contact your doctor or||
7152|072|S|pharmacist.||
7152|073|S|   In the US -||
7152|074|S|   Call your doctor for medical advice about side effects. You||
7152|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7152|076|S|www.fda.gov/medwatch.||
7152|077|S|   In Canada - Call your doctor for medical advice about side||
7152|078|S|effects. You may report side effects to Health Canada at||
7152|079|S|1-866-234-2345.||
7152|080|B|||
7152|081|P|PRECAUTIONS:  Before taking oxybutynin, tell your doctor or||
7152|082|P|pharmacist if you are allergic to it; or if you have any other||
7152|083|P|allergies. This product may contain inactive ingredients, which||
7152|084|P|can cause allergic reactions or other problems. Talk to your||
7152|085|P|pharmacist for more details.||
7152|086|P|   Before using this medication, tell your doctor or pharmacist||
7152|087|P|your medical history, especially of: glaucoma, bladder disease||
7152|088|P|(such as bladder outflow blockage, urinary retention), certain||
7152|089|P|muscle disease (myasthenia gravis), heart disease (such as heart||
7152|090|P|failure, coronary artery disease, arrhythmias), high blood||
7152|091|P|pressure, liver disease, kidney disease, loss of mental abilities||
7152|092|P|(dementia), certain nervous system disorder (autonomic||
7152|093|P|neuropathy), enlarged prostate gland (benign prostatic||
7152|094|P|hypertrophy-BPH), stomach/intestinal disease (such as blockage,||
7152|095|P|paralytic ileus, acid reflux disease, hiatal hernia, ulcerative||
7152|096|P|colitis), severe throat/stomach/intestinal narrowing||
7152|097|P|(strictures), overactive thyroid (hyperthyroidism), Parkinson's||
7152|098|P|disease.||
7152|099|P|   This drug may make you dizzy or drowsy or blur your vision.||
7152|100|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7152|101|P|drowsy. Do not drive, use machinery, or do anything that needs||
7152|102|P|alertness or clear vision until you can do it safely. Limit||
7152|103|P|alcoholic beverages. Talk to your doctor if you are using||
7152|104|P|marijuana (cannabis).||
7152|105|P|   Before having surgery, tell your doctor or dentist about all||
7152|106|P|the products you use (including prescription drugs,||
7152|107|P|nonprescription drugs, and herbal products).||
7152|108|P|   This drug may make you sweat less, making you more likely to||
7152|109|P|get heat stroke. Avoid doing things that may cause you to||
7152|110|P|overheat, such as hard work or exercise in hot weather, or using||
7152|111|P|hot tubs. When the weather is hot, drink a lot of fluids and||
7152|112|P|dress lightly. If you overheat, quickly look for a place to cool||
7152|113|P|down and rest. Get medical help right away if you have a fever||
7152|114|P|that does not go away, mental/mood changes, headache, or||
7152|115|P|dizziness.||
7152|116|P|   Older adults may be more sensitive to the side effects of this||
7152|117|P|drug, especially drowsiness, confusion, constipation, trouble||
7152|118|P|urinating. Drowsiness and confusion can increase the risk of||
7152|119|P|falling.||
7152|120|P|   During pregnancy, this medication should be used only when||
7152|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
7152|122|P|   It is unknown if this medication passes into breast milk.||
7152|123|P|Consult your doctor before breastfeeding.||
7152|124|B|||
7152|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7152|126|I|medications work or increase your risk for serious side effects.||
7152|127|I|This document does not contain all possible drug interactions.||
7152|128|I|Keep a list of all the products you use (including||
7152|129|I|prescription/nonprescription drugs and herbal products) and share||
7152|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
7152|131|I|the dosage of any medicines without your doctor's approval.||
7152|132|I|   Some products that may interact with this drug include:||
7152|133|I|pramlintide, drugs that can irritate the esophagus/stomach (such||
7152|134|I|as potassium tablets/capsules, oral bisphosphonates including||
7152|135|I|alendronate).||
7152|136|I|   Tell your doctor or pharmacist if you are taking other||
7152|137|I|products that cause drowsiness such as opioid pain or cough||
7152|138|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7152|139|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
7152|140|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7152|141|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7152|142|I|diphenhydramine).||
7152|143|I|   Check the labels on all your medicines (such as allergy or||
7152|144|I|cough-and-cold products) because they may contain ingredients||
7152|145|I|that can cause drowsiness, constipation or blurred vision. Ask||
7152|146|I|your pharmacist about using those products safely.||
7152|147|B|||
7152|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7152|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7152|150|O|poison control center right away. US residents can call||
7152|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7152|152|O|Symptoms of overdose may include: delirium and paralysis.||
7152|153|B|||
7152|154|N|NOTES:  Do not share this medication with others.||
7152|155|B|||
7152|156|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7152|157|D|If it is near the time of the next dose, skip the missed dose.||
7152|158|D|Use your next dose at the regular time. Do not double the dose to||
7152|159|D|catch up.||
7152|160|B|||
7152|161|R|STORAGE:  Store at room temperature away from light and moisture.||
7152|162|R|Do not store in the bathroom. Keep all medications away from||
7152|163|R|children and pets.||
7152|164|R|   Do not flush medications down the toilet or pour them into a||
7152|165|R|drain unless instructed to do so. Properly discard this product||
7152|166|R|when it is expired or no longer needed. Consult your pharmacist||
7152|167|R|or local waste disposal company.||
7152|168|B|||
7152|169|A|Information last revised October 2025.||
7152|170|A|Copyright(c) 2025 First Databank, Inc.||
7152|171|B|||
7154|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7154|002|Z|does NOT have all possible information about this product. This||
7154|003|Z|information does not assure that this product is safe, effective,||
7154|004|Z|or appropriate for you. This information is not individual||
7154|005|Z|medical advice and does not substitute for the advice of your||
7154|006|Z|health care professional. Always ask your health care||
7154|007|Z|professional for complete information about this product and your||
7154|008|Z|specific health needs.||
7154|009|B|||
7154|010|T|VANCOMYCIN SOLUTION - ORAL||
7154|011|F|(VAN-koe-MYE-sin)||
7154|012|B|||
7154|013|C|COMMON BRAND NAME(S): Firvanq||
7154|014|B|||
7154|015|U|USES:  Vancomycin is an antibiotic used to treat infections. This||
7154|016|U|form of vancomycin is used to treat a certain intestinal||
7154|017|U|condition (colitis) caused by bacteria. This condition causes||
7154|018|U|diarrhea and stomach/abdominal discomfort or pain. When||
7154|019|U|vancomycin is taken by mouth, it stays in the intestines to stop||
7154|020|U|the growth of certain bacteria that cause these symptoms.||
7154|021|U|   This antibiotic treats only bacterial infection in the||
7154|022|U|intestines. It will not work for bacterial infections in any||
7154|023|U|other part of the body or for viral infections (such as common||
7154|024|U|cold, flu). Using any antibiotic when it is not needed can cause||
7154|025|U|it to not work for future infections.||
7154|026|B|||
7154|027|H|HOW TO USE:  Take this medication by mouth as directed by your||
7154|028|H|doctor, usually every 6 to 8 hours. Shake the bottle well before||
7154|029|H|each dose. Carefully measure the dose using a special measuring||
7154|030|H|device/spoon. Do not use a household spoon because you may not||
7154|031|H|get the correct dose.||
7154|032|H|   The dosage is based on your medical condition and response to||
7154|033|H|treatment. Children's dosage is also based on weight.||
7154|034|H|   If you are also taking certain bile acid-binding cholesterol||
7154|035|H|medication (such as cholestyramine, colestipol), take it at least||
7154|036|H|3 to 4 hours after taking vancomycin. Taking them together will||
7154|037|H|make vancomycin work less well. Ask your pharmacist if you have||
7154|038|H|questions.||
7154|039|H|   For the best effect, take this antibiotic at evenly spaced||
7154|040|H|times. To help you remember, take this medication at the same||
7154|041|H|times every day.||
7154|042|H|   Continue to take this medication until the full prescribed||
7154|043|H|amount is finished, even if symptoms disappear after a few days.||
7154|044|H|Stopping the medication too early may result in a return of the||
7154|045|H|infection.||
7154|046|H|   Tell your doctor if your condition lasts or gets worse.||
7154|047|B|||
7154|048|S|SIDE EFFECTS:  Abdominal pain, nausea, or vomiting may occur. If||
7154|049|S|any of these effects last or get worse, tell your doctor or||
7154|050|S|pharmacist promptly.||
7154|051|S|   Remember that this medication has been prescribed because your||
7154|052|S|doctor has judged that the benefit to you is greater than the||
7154|053|S|risk of side effects. Many people using this medication do not||
7154|054|S|have serious side effects.||
7154|055|S|   Tell your doctor right away if you have any serious side||
7154|056|S|effects, including: hearing problems (such as ringing in the||
7154|057|S|ears, hearing loss), signs of kidney problems (such as change in||
7154|058|S|the amount of urine).||
7154|059|S|   A very serious allergic reaction to this drug is rare.||
7154|060|S|However, get medical help right away if you notice any symptoms||
7154|061|S|of a serious allergic reaction, including: fever that doesn't go||
7154|062|S|away, new or worsening lymph node swelling, rash,||
7154|063|S|itching/swelling (especially of the face/tongue/throat), severe||
7154|064|S|dizziness, trouble breathing.||
7154|065|S|   This is not a complete list of possible side effects. If you||
7154|066|S|notice other effects not listed above, contact your doctor or||
7154|067|S|pharmacist.||
7154|068|S|   In the US -||
7154|069|S|   Call your doctor for medical advice about side effects. You||
7154|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7154|071|S|www.fda.gov/medwatch.||
7154|072|S|   In Canada - Call your doctor for medical advice about side||
7154|073|S|effects. You may report side effects to Health Canada at||
7154|074|S|1-866-234-2345.||
7154|075|B|||
7154|076|P|PRECAUTIONS:  Before taking vancomycin, tell your doctor or||
7154|077|P|pharmacist if you are allergic to it; or if you have any other||
7154|078|P|allergies. This product may contain inactive ingredients, which||
7154|079|P|can cause allergic reactions or other problems. Talk to your||
7154|080|P|pharmacist for more details.||
7154|081|P|   Before using this medication, tell your doctor or pharmacist||
7154|082|P|your medical history, especially of: kidney disease, hearing||
7154|083|P|problems.||
7154|084|P|   Before having surgery, tell your doctor or dentist about all||
7154|085|P|the products you use (such as prescription drugs, nonprescription||
7154|086|P|drugs, and herbal products).||
7154|087|P|   Older adults may be more sensitive to the side effects of this||
7154|088|P|drug, especially kidney problems.||
7154|089|P|   During pregnancy, this medication should be used only when||
7154|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
7154|091|P|   It is unknown if this form of vancomycin passes into breast||
7154|092|P|milk. Consult your doctor before breastfeeding.||
7154|093|B|||
7154|094|I|DRUG INTERACTIONS:  See also How to Use section.||
7154|095|I|   Drug interactions may change how your medications work or||
7154|096|I|increase your risk for serious side effects. This document does||
7154|097|I|not contain all possible drug interactions. Keep a list of all||
7154|098|I|the products you use (including prescription/nonprescription||
7154|099|I|drugs and herbal products) and share it with your doctor and||
7154|100|I|pharmacist. Do not start, stop, or change the dosage of any||
7154|101|I|medicines without your doctor's approval.||
7154|102|B|||
7154|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7154|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7154|105|O|poison control center right away. US residents can call||
7154|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7154|107|B|||
7154|108|N|NOTES:  Do not share this medication with others.||
7154|109|N|   This medication has been prescribed for your current condition||
7154|110|N|only. Do not use it later for another infection unless your||
7154|111|N|doctor tells you to.||
7154|112|N|   Lab and/or medical tests (such as stool samples, kidney||
7154|113|N|function) should be done while you are taking this medication.||
7154|114|N|Keep all medical and lab appointments.||
7154|115|B|||
7154|116|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7154|117|D|remember. If it is near the time of the next dose, skip the||
7154|118|D|missed dose. Take your next dose at the regular time. Do not||
7154|119|D|double the dose to catch up.||
7154|120|B|||
7154|121|R|STORAGE:  Store this medication in the refrigerator. Do not||
7154|122|R|freeze. Discard any unused medication after 14 days. Keep all||
7154|123|R|medications away from children and pets.||
7154|124|R|   Do not flush medications down the toilet or pour them into a||
7154|125|R|drain unless instructed to do so. Properly discard this product||
7154|126|R|when it is expired or no longer needed. Consult your pharmacist||
7154|127|R|or local waste disposal company.||
7154|128|B|||
7154|129|A|Information last revised November 2025.||
7154|130|A|Copyright(c) 2025 First Databank, Inc.||
7154|131|B|||
7156|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7156|002|Z|does NOT have all possible information about this product. This||
7156|003|Z|information does not assure that this product is safe, effective,||
7156|004|Z|or appropriate for you. This information is not individual||
7156|005|Z|medical advice and does not substitute for the advice of your||
7156|006|Z|health care professional. Always ask your health care||
7156|007|Z|professional for complete information about this product and your||
7156|008|Z|specific health needs.||
7156|009|B|||
7156|010|T|STANNOUS FLUORIDE GEL - DENTAL||
7156|011|F|(STAN-us FLOOR-ide)||
7156|012|B|||
7156|013|C|COMMON BRAND NAME(S): Flo-Gel, Gel-Kam||
7156|014|B|||
7156|015|U|USES:  This medication is applied to teeth to prevent cavities.||
7156|016|U|Fluoride is a mineral that works by making the teeth stronger and||
7156|017|U|more resistant to decay caused by acid and bacteria.||
7156|018|U|   Do not use this medication in children younger than 12 years||
7156|019|U|unless directed to do so by your dentist/doctor.||
7156|020|B|||
7156|021|H|HOW TO USE:  Read and follow all directions on the product||
7156|022|H|package before taking this medication. If you have any questions,||
7156|023|H|consult your pharmacist. Use this gel once daily or as directed||
7156|024|H|by your dentist/doctor.||
7156|025|H|   After brushing with toothpaste, apply this medication to your||
7156|026|H|teeth and brush thoroughly. Allow the gel to remain on your teeth||
7156|027|H|for 1 minute, then spit out. Try not to swallow the medication.||
7156|028|H|   Carefully watch children during use to prevent repeated||
7156|029|H|swallowing of the gel.||
7156|030|H|   To get the most benefit, you should not eat, drink, or rinse||
7156|031|H|your mouth for at least 30 minutes after using the gel.||
7156|032|H|   Dosage is based on age and the amount of fluoride in your||
7156|033|H|drinking water. Do not exceed the recommended dose without||
7156|034|H|checking with your dentist/doctor. Doing so will not do more to||
7156|035|H|prevent cavities but may lead to side effects instead.||
7156|036|H|   Use this medication regularly to get the most benefit from it.||
7156|037|H|To help you remember, use it at the same time each day.||
7156|038|H|   Do not treat this medication like a normal toothpaste: do not||
7156|039|H|use it more often than prescribed, or just to brush your teeth.||
7156|040|B|||
7156|041|S|SIDE EFFECTS:  Temporary staining of the teeth may occur.||
7156|042|S|Brushing may control these stains, which can be removed by your||
7156|043|S|dental professional. If this effect lasts or gets worse, tell||
7156|044|S|your dentist or doctor promptly.||
7156|045|S|   Tell your dentist/doctor right away if you notice any changes||
7156|046|S|in the color or appearance of your teeth. These effects may be a||
7156|047|S|result of too much fluoride.||
7156|048|S|   If your doctor or dentist has directed you to use this||
7156|049|S|medication, remember that your doctor or dentist has judged that||
7156|050|S|the benefit to you is greater than the risk of side effects. Many||
7156|051|S|people using this medication do not have serious side effects.||
7156|052|S|   A very serious allergic reaction to this drug is rare.||
7156|053|S|However, get medical help right away if you notice any symptoms||
7156|054|S|of a serious allergic reaction, including: rash, itching/swelling||
7156|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7156|056|S|breathing.||
7156|057|S|   This is not a complete list of possible side effects. If you||
7156|058|S|notice other effects not listed above, contact your doctor or||
7156|059|S|pharmacist.||
7156|060|S|   In the US -||
7156|061|S|   Call your doctor for medical advice about side effects. You||
7156|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7156|063|S|www.fda.gov/medwatch.||
7156|064|S|   In Canada - Call your doctor for medical advice about side||
7156|065|S|effects. You may report side effects to Health Canada at||
7156|066|S|1-866-234-2345.||
7156|067|B|||
7156|068|P|PRECAUTIONS:  Before using stannous fluoride, tell your doctor or||
7156|069|P|pharmacist if you are allergic to it; or if you have any other||
7156|070|P|allergies. This product may contain inactive ingredients, which||
7156|071|P|can cause allergic reactions or other problems. Talk to your||
7156|072|P|pharmacist for more details.||
7156|073|P|   Before using this medication, tell your doctor or pharmacist||
7156|074|P|your medical history, especially of: mouth problems (such as||
7156|075|P|sores, mucositis).||
7156|076|P|   Children may be more sensitive to the side effects of this||
7156|077|P|drug, especially if they swallow this medication.||
7156|078|P|   Tell your doctor if you are pregnant before using this||
7156|079|P|medication.||
7156|080|P|   This medication passes into breast milk. Consult your doctor||
7156|081|P|before breastfeeding.||
7156|082|B|||
7156|083|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7156|084|I|medications work or increase your risk for serious side effects.||
7156|085|I|This document does not contain all possible drug interactions.||
7156|086|I|Keep a list of all the products you use (including||
7156|087|I|prescription/nonprescription drugs and herbal products) and share||
7156|088|I|it with your doctor and pharmacist. Do not start, stop, or change||
7156|089|I|the dosage of any medicines without your doctor's approval.||
7156|090|B|||
7156|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7156|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7156|093|O|poison control center right away. US residents can call||
7156|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7156|095|O|Symptoms of overdose may include: burning in the mouth, sore||
7156|096|O|tongue, nausea, vomiting, diarrhea, increased saliva, stomach||
7156|097|O|pain/cramping, muscle weakness, shaking, seizures.||
7156|098|B|||
7156|099|N|NOTES:  Do not share this medication with others.||
7156|100|N|   Using this medication does not replace good dental habits.||
7156|101|N|Continue to brush and floss your teeth regularly as directed by||
7156|102|N|your dentist, and have regular dental checkups.||
7156|103|B|||
7156|104|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7156|105|D|If it is near the time of the next dose, skip the missed dose.||
7156|106|D|Use your next dose at the regular time. Do not double the dose to||
7156|107|D|catch up.||
7156|108|B|||
7156|109|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
7156|110|R|medications away from children and pets.||
7156|111|R|   Do not flush medications down the toilet or pour them into a||
7156|112|R|drain unless instructed to do so. Properly discard this product||
7156|113|R|when it is expired or no longer needed. Consult your pharmacist||
7156|114|R|or local waste disposal company.||
7156|115|B|||
7156|116|A|Information last revised May 2024.||
7156|117|A|Copyright(c) 2025 First Databank, Inc.||
7156|118|B|||
7157|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7157|002|Z|does NOT have all possible information about this product. This||
7157|003|Z|information does not assure that this product is safe, effective,||
7157|004|Z|or appropriate for you. This information is not individual||
7157|005|Z|medical advice and does not substitute for the advice of your||
7157|006|Z|health care professional. Always ask your health care||
7157|007|Z|professional for complete information about this product and your||
7157|008|Z|specific health needs.||
7157|009|B|||
7157|010|T|MEASLES/MUMPS/RUBELLA VACCINE - INJECTION||
7157|011|F|(MEE-zulz/mumps/ roo-BEL-a)||
7157|012|B|||
7157|013|C|COMMON BRAND NAME(S): MMR II||
7157|014|B|||
7157|015|U|USES:  This vaccine is used to help prevent measles (also known||
7157|016|U|as rubeola), mumps, and rubella (also known as German measles).||
7157|017|U|These infections may cause serious problems (such as deafness,||
7157|018|U|lung/brain problems, harm to an unborn baby). Vaccination is the||
7157|019|U|best way to protect against these life-threatening infections.||
7157|020|U|   This vaccine contains live viruses that have been weakened. It||
7157|021|U|works by increasing the body's natural defense (immunity) against||
7157|022|U|the viruses.||
7157|023|U|   Vaccines may not fully protect everyone who receives them.||
7157|024|B|||
7157|025|H|HOW TO USE:  Read all vaccine information available from your||
7157|026|H|health care professional before receiving the vaccine. If you||
7157|027|H|have any questions, ask your health care professional.||
7157|028|H|   This vaccine is given by injection by a health care||
7157|029|H|professional. Depending on the brand, it may be given either||
7157|030|H|under the skin or into the muscle of the upper arm.||
7157|031|H|   Vaccines are usually given in a series of doses to provide the||
7157|032|H|best protection. In some cases, adults may only need one dose of||
7157|033|H|this vaccine. Closely follow the vaccination schedule provided by||
7157|034|H|your health care professional. To help you remember, mark your||
7157|035|H|calendar with a reminder.||
7157|036|H|   This vaccine may be given at the same time as other vaccines.||
7157|037|B|||
7157|038|S|SIDE EFFECTS:  Pain/redness/swelling at the injection site,||
7157|039|S|fever, or mild rash may occur. If any of these effects last or||
7157|040|S|get worse, tell your health care professional promptly.||
7157|041|S|   Rarely, some people have symptoms such as fainting, dizziness,||
7157|042|S|vision changes, or ringing in the ears just after getting a||
7157|043|S|vaccine injection. Tell your health care professional right away||
7157|044|S|if you have any of these symptoms. Sitting or lying down may||
7157|045|S|help, since these symptoms usually don't last long.||
7157|046|S|   Remember that this vaccine has been prescribed because your||
7157|047|S|health care professional has judged that the benefit to you is||
7157|048|S|greater than the risk of side effects. Many people using this||
7157|049|S|vaccine do not have serious side effects.||
7157|050|S|   Tell your health care professional right away if you have any||
7157|051|S|serious side effects, including: joint pain/stiffness, easy||
7157|052|S|bruising/bleeding, seizures, mental/mood changes (such as||
7157|053|S|confusion).||
7157|054|S|   A very serious allergic reaction to this vaccine is rare.||
7157|055|S|However, get medical help right away if you notice any symptoms||
7157|056|S|of a serious allergic reaction, including: rash, itching/swelling||
7157|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7157|058|S|breathing.||
7157|059|S|   This is not a complete list of possible side effects. If you||
7157|060|S|notice other effects not listed above, contact your health care||
7157|061|S|professional.||
7157|062|S|   Contact the health care professional for medical advice about||
7157|063|S|side effects. The following numbers do not provide medical||
7157|064|S|advice, but in the US you may report side effects to the Vaccine||
7157|065|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
7157|066|S|Canada, you may call the Vaccine Safety Section at Public Health||
7157|067|S|Agency of Canada at 1-866-844-0018.||
7157|068|B|||
7157|069|P|PRECAUTIONS:  Before you receive this vaccine, tell your health||
7157|070|P|care professional if you are allergic to it; or if you have any||
7157|071|P|other allergies. This product may contain inactive ingredients||
7157|072|P|(such as neomycin, latex found in some brands), which can cause||
7157|073|P|allergic reactions or other problems. Talk to your health care||
7157|074|P|professional for more details.||
7157|075|P|   Before receiving this vaccine, tell your health care||
7157|076|P|professional your medical history, especially of: current||
7157|077|P|fever/illness (such as tuberculosis), immune system disorders||
7157|078|P|(such as due to HIV infection, certain cancers such as||
7157|079|P|leukemia/lymphoma, cancer or radiation treatment), bleeding/blood||
7157|080|P|clotting problems (such as hemophilia, low platelets), brain||
7157|081|P|disorders (such as seizures, head injury), blood/plasma||
7157|082|P|transfusions, vaccination history (including previous reactions||
7157|083|P|to any vaccines).||
7157|084|P|   Tell your health care professional if you are pregnant or plan||
7157|085|P|to become pregnant. This vaccine should not be given if you are||
7157|086|P|pregnant. It may harm an unborn baby. Avoid getting pregnant for||
7157|087|P|4 weeks after receiving this vaccine. Talk to your health care||
7157|088|P|professional for details.||
7157|089|P|   The rubella vaccine virus passes into breast milk. It is||
7157|090|P|unknown if the measles or mumps vaccine virus passes into breast||
7157|091|P|milk. Consult your health care professional before breastfeeding.||
7157|092|B|||
7157|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7157|094|I|medications work or increase your risk for serious side effects.||
7157|095|I|This document does not contain all possible drug interactions.||
7157|096|I|Keep a list of all the products you use (including||
7157|097|I|prescription/nonprescription drugs and herbal products) and share||
7157|098|I|it with your health care professional. Do not start, stop, or||
7157|099|I|change the dosage of any medicines without your doctor's||
7157|100|I|approval.||
7157|101|I|   Some products that may interact with this vaccine are: drugs||
7157|102|I|that weaken the immune system (including cyclosporine,||
7157|103|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
7157|104|I|prednisone), immune globulin.||
7157|105|I|   This vaccine may interfere with certain lab tests (including||
7157|106|I|TB skin test), possibly causing false test results. Make sure lab||
7157|107|I|personnel and all your doctors know you recently received this||
7157|108|I|vaccine.||
7157|109|B|||
7157|110|O|OVERDOSE:  Not applicable.||
7157|111|B|||
7157|112|N|NOTES:  Keep all medical and lab appointments.||
7157|113|N|   Keep vaccine records for yourself and your children and||
7157|114|N|provide them to the health care professionals to prevent||
7157|115|N|unnecessary re-vaccinations.||
7157|116|B|||
7157|117|D|MISSED DOSE:  It is important that you get each vaccination as||
7157|118|D|scheduled. Ask when you should get each dose and mark your||
7157|119|D|calendar with a reminder. If you miss a dose, call the health||
7157|120|D|care professional to reschedule.||
7157|121|B|||
7157|122|R|STORAGE:  Store in the refrigerator. Protect from light. Keep all||
7157|123|R|medications away from children and pets.||
7157|124|R|   Do not flush medications down the toilet or pour them into a||
7157|125|R|drain unless instructed to do so. Properly discard this product||
7157|126|R|when it is expired or no longer needed. Consult your pharmacist||
7157|127|R|or local waste disposal company.||
7157|128|B|||
7157|129|A|Information last revised February 2025.||
7157|130|A|Copyright(c) 2025 First Databank, Inc.||
7157|131|B|||
7159|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7159|002|Z|does NOT have all possible information about this product. This||
7159|003|Z|information does not assure that this product is safe, effective,||
7159|004|Z|or appropriate for you. This information is not individual||
7159|005|Z|medical advice and does not substitute for the advice of your||
7159|006|Z|health care professional. Always ask your health care||
7159|007|Z|professional for complete information about this product and your||
7159|008|Z|specific health needs.||
7159|009|B|||
7159|010|T|DARBEPOETIN ALFA - INJECTION||
7159|011|F|(DAR-be-POE-e-tin AL-fa)||
7159|012|B|||
7159|013|C|COMMON BRAND NAME(S): Aranesp||
7159|014|B|||
7159|015|W|WARNING:  Discuss the risks and benefits of darbepoetin alfa with||
7159|016|W|your doctor, as this medication may rarely cause very serious||
7159|017|W|(possibly fatal) side effects, including blood clots, heart||
7159|018|W|attack, stroke, or heart failure. It is very important to keep||
7159|019|W|all lab appointments since your doctor will need to carefully||
7159|020|W|check your red blood cell count and hemoglobin level. The lowest||
7159|021|W|effective dose of this medication should be used.||
7159|022|W|   When used to treat anemia related to cancer, darbepoetin alfa||
7159|023|W|may also increase the risk of death and/or cause your tumor to||
7159|024|W|grow faster. This medication should be stopped after completing a||
7159|025|W|treatment course of chemotherapy as directed by your doctor.||
7159|026|B|||
7159|027|U|USES:  This medication is used to treat anemia (low red blood||
7159|028|U|cell count) in people with long-term serious kidney disease||
7159|029|U|(chronic kidney failure) and people receiving chemotherapy for||
7159|030|U|some types of cancer (cancer that does not involve the bone||
7159|031|U|marrow or blood cells). Darbepoetin alfa also helps to reduce the||
7159|032|U|need for blood transfusions. It works by signaling the bone||
7159|033|U|marrow to make more red blood cells. This medication is very||
7159|034|U|similar to the natural substance in your body (erythropoietin)||
7159|035|U|that prevents anemia.||
7159|036|B|||
7159|037|H|HOW TO USE:  Read the Medication Guide and, if available, the||
7159|038|H|Instructions for Use provided by your pharmacist before you start||
7159|039|H|using this medication and each time you get a refill. If you have||
7159|040|H|any questions, ask your doctor or pharmacist.||
7159|041|H|   This medication is given as an injection under the skin or||
7159|042|H|into a vein as directed by your doctor. Hemodialysis patients||
7159|043|H|should receive this medication by injection into a vein. The||
7159|044|H|dosage is based on your medical condition, weight, labs, and||
7159|045|H|response to treatment.||
7159|046|H|   If you are using this medication at home, learn all||
7159|047|H|preparation and usage instructions from your health care||
7159|048|H|professional. Take the medication out of the refrigerator to||
7159|049|H|allow it to reach room temperature. Do not shake the medication.||
7159|050|H|Before using, check this product for particles or discoloration.||
7159|051|H|If either is present, do not use the liquid. If you are injecting||
7159|052|H|this medication under the skin, before each dose, clean the skin||
7159|053|H|you are going to inject into (the injection site) with rubbing||
7159|054|H|alcohol. Change the injection site each time to lessen injury||
7159|055|H|under the skin. To lessen bruising, do not rub the injection site||
7159|056|H|after a shot. Learn how to store and discard medical supplies||
7159|057|H|safely.||
7159|058|H|   Use this medication regularly to get the most benefit from it.||
7159|059|H|To help you remember, use it on the same day of the week as||
7159|060|H|directed.||
7159|061|H|   Do not increase your dose or use this drug more often or for||
7159|062|H|longer than prescribed. Your condition will not improve any||
7159|063|H|faster, and your risk of side effects will increase.||
7159|064|H|   It may take 2 to 6 weeks before your red blood cell count||
7159|065|H|increases. Tell your doctor if your symptoms do not get better or||
7159|066|H|if they get worse.||
7159|067|B|||
7159|068|S|SIDE EFFECTS:  Headache, body aches, diarrhea, cough,||
7159|069|S|stomach/abdominal pain, or injection site pain may occur. If any||
7159|070|S|of these effects last or get worse, tell your doctor or||
7159|071|S|pharmacist promptly.||
7159|072|S|   Remember that this medication has been prescribed because your||
7159|073|S|doctor has judged that the benefit to you is greater than the||
7159|074|S|risk of side effects. Many people using this medication do not||
7159|075|S|have serious side effects.||
7159|076|S|   Darbepoetin alfa may sometimes cause or worsen high blood||
7159|077|S|pressure, especially in patients with long-term kidney failure.||
7159|078|S|This effect may be caused by the number of red blood cells||
7159|079|S|increasing too quickly, usually within the first 3 months of||
7159|080|S|starting treatment. If you have high blood pressure, it should be||
7159|081|S|well controlled before beginning treatment with this medication.||
7159|082|S|Your blood pressure should be checked often. Ask your doctor if||
7159|083|S|you should learn how to check your own blood pressure. If high||
7159|084|S|blood pressure develops or worsens, follow your doctor's||
7159|085|S|instructions about diet changes and starting or adjusting your||
7159|086|S|high blood pressure medication. Lowering high blood pressure||
7159|087|S|helps prevent strokes, heart attacks, and further kidney||
7159|088|S|problems. Keep all lab appointments to have your red blood cell||
7159|089|S|count/hemoglobin level tested regularly to reduce the chance of||
7159|090|S|this side effect.||
7159|091|S|   Rarely, this medication may suddenly stop working well after a||
7159|092|S|period of time because your body may make antibodies to it. A||
7159|093|S|very serious anemia can result. Tell your doctor right away if||
7159|094|S|symptoms of anemia return (such as increased tiredness, low||
7159|095|S|energy, pale skin color, shortness of breath).||
7159|096|S|   Tell your doctor right away if you have any serious side||
7159|097|S|effects, including: symptoms of heart failure (such as shortness||
7159|098|S|of breath, swelling ankles/feet, unusual tiredness,||
7159|099|S|unusual/sudden weight gain).||
7159|100|S|   Get medical help right away if you have any very serious side||
7159|101|S|effects, including: seizures.||
7159|102|S|   This medication may rarely cause serious (sometimes fatal)||
7159|103|S|problems from blood clots (such as heart attack, stroke, blood||
7159|104|S|clots in the legs or lungs). Get medical help right away if you||
7159|105|S|have: shortness of breath/rapid breathing, chest/jaw/left arm||
7159|106|S|pain, unusual sweating, confusion, sudden dizziness/fainting,||
7159|107|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
7159|108|S|trouble speaking, weakness on one side of the body, sudden vision||
7159|109|S|changes, blood clots in your hemodialysis vascular access site.||
7159|110|S|   A very serious allergic reaction to this drug is rare.||
7159|111|S|However, get medical help right away if you notice any symptoms||
7159|112|S|of a serious allergic reaction, including: rash, itching/swelling||
7159|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7159|114|S|breathing.||
7159|115|S|   This is not a complete list of possible side effects. If you||
7159|116|S|notice other effects not listed above, contact your doctor or||
7159|117|S|pharmacist.||
7159|118|S|   In the US -||
7159|119|S|   Call your doctor for medical advice about side effects. You||
7159|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7159|121|S|www.fda.gov/medwatch.||
7159|122|S|   In Canada - Call your doctor for medical advice about side||
7159|123|S|effects. You may report side effects to Health Canada at||
7159|124|S|1-866-234-2345.||
7159|125|B|||
7159|126|P|PRECAUTIONS:  Before using darbepoetin alfa, tell your doctor or||
7159|127|P|pharmacist if you are allergic to it; or to other drugs that||
7159|128|P|cause more red blood cells to be made (such as epoetin alfa); or||
7159|129|P|if you have any other allergies. This product may contain||
7159|130|P|inactive ingredients (such as polysorbate, latex), which can||
7159|131|P|cause allergic reactions or other problems. Talk to your||
7159|132|P|pharmacist for more details.||
7159|133|P|   Before using this medication, tell your doctor or pharmacist||
7159|134|P|your medical history, especially of: high blood pressure, heart||
7159|135|P|disease (such as heart failure, past heart attack/stroke),||
7159|136|P|seizure disorder, severe anemia caused by antibodies to past||
7159|137|P|erythropoietin-type treatment (pure red cell aplasia).||
7159|138|P|   Before having surgery, tell your doctor or dentist about all||
7159|139|P|the products you use (including prescription drugs,||
7159|140|P|nonprescription drugs, and herbal products).||
7159|141|P|   During pregnancy, this medication should be used only when||
7159|142|P|clearly needed. Discuss the risks and benefits with your doctor.||
7159|143|P|   It is unknown if this medication passes into breast milk.||
7159|144|P|Consult your doctor before breastfeeding.||
7159|145|B|||
7159|146|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7159|147|I|medications work or increase your risk for serious side effects.||
7159|148|I|This document does not contain all possible drug interactions.||
7159|149|I|Keep a list of all the products you use (including||
7159|150|I|prescription/nonprescription drugs and herbal products) and share||
7159|151|I|it with your doctor and pharmacist. Do not start, stop, or change||
7159|152|I|the dosage of any medicines without your doctor's approval.||
7159|153|B|||
7159|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7159|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7159|156|O|poison control center right away. US residents can call||
7159|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7159|158|B|||
7159|159|N|NOTES:  Do not share this medication with others.||
7159|160|N|   Lab and/or medical tests (such as blood pressure, complete||
7159|161|N|blood count that includes hemoglobin level) should be done while||
7159|162|N|you are using this medication. Keep all medical and lab||
7159|163|N|appointments. Consult your doctor for more details.||
7159|164|N|   Blood tests for your iron levels will also be done and you may||
7159|165|N|be prescribed iron supplements to take. Your doctor may recommend||
7159|166|N|that you eat a well-balanced diet rich in iron (such as raisins,||
7159|167|N|figs, meat, eggs, vegetables, iron-fortified cereals). Follow||
7159|168|N|your doctor's instructions and dietary recommendations.||
7159|169|B|||
7159|170|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
7159|171|D|right away for a new dosing schedule. Do not double the dose to||
7159|172|D|catch up.||
7159|173|B|||
7159|174|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
7159|175|R|medication in the original carton to protect from light. After||
7159|176|R|each dose, discard any unused medication right away. Keep all||
7159|177|R|medications away from children and pets.||
7159|178|R|   Do not flush medications down the toilet or pour them into a||
7159|179|R|drain unless instructed to do so. Properly discard this product||
7159|180|R|when it is expired or no longer needed. Consult your pharmacist||
7159|181|R|or local waste disposal company.||
7159|182|B|||
7159|183|A|Information last revised October 2024.||
7159|184|A|Copyright(c) 2025 First Databank, Inc.||
7159|185|B|||
7164|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7164|002|Z|does NOT have all possible information about this product. This||
7164|003|Z|information does not assure that this product is safe, effective,||
7164|004|Z|or appropriate for you. This information is not individual||
7164|005|Z|medical advice and does not substitute for the advice of your||
7164|006|Z|health care professional. Always ask your health care||
7164|007|Z|professional for complete information about this product and your||
7164|008|Z|specific health needs.||
7164|009|B|||
7164|010|T|AMMONIUM LACTATE 12% - TOPICAL||
7164|011|F|(a-MOE-nee-um LAK-tate)||
7164|012|B|||
7164|013|C|COMMON BRAND NAME(S): Lac-Hydrin||
7164|014|B|||
7164|015|U|USES:  This medication is used to treat dry, scaly skin||
7164|016|U|conditions (such as xerosis, ichthyosis vulgaris) and can also||
7164|017|U|help relieve itching from these conditions. This medication works||
7164|018|U|by increasing the moisture in the skin.||
7164|019|B|||
7164|020|H|HOW TO USE:  If you are using the lotion, shake the bottle well||
7164|021|H|before using.||
7164|022|H|   Apply a thin layer of this medication to the affected areas of||
7164|023|H|the skin, usually twice daily or as directed by your doctor. Rub||
7164|024|H|the medication thoroughly into the skin.||
7164|025|H|   Be careful to avoid your eyes, lips, inside your mouth/nose,||
7164|026|H|the vaginal area, and any areas of broken skin. Stinging or||
7164|027|H|burning may occur when this medication is applied on the face, on||
7164|028|H|chapped skin, or on a recently shaved area of the skin. Consult||
7164|029|H|your doctor or pharmacist for more details.||
7164|030|H|   Tell your doctor if your condition does not get better or if||
7164|031|H|it gets worse.||
7164|032|B|||
7164|033|S|SIDE EFFECTS:  Stinging, burning, and redness may occur. If any||
7164|034|S|of these effects last or get worse, tell your doctor or||
7164|035|S|pharmacist promptly.||
7164|036|S|   If your doctor has directed you to use this medication,||
7164|037|S|remember that your doctor has judged that the benefit to you is||
7164|038|S|greater than the risk of side effects. Many people using this||
7164|039|S|medication do not have serious side effects.||
7164|040|S|   Tell your doctor right away if you have any serious side||
7164|041|S|effects, including: darkening/lightening of the skin, small red||
7164|042|S|dots on the skin.||
7164|043|S|   A very serious allergic reaction to this drug is rare.||
7164|044|S|However, get medical help right away if you notice any symptoms||
7164|045|S|of a serious allergic reaction, including: rash, itching/swelling||
7164|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7164|047|S|breathing.||
7164|048|S|   This is not a complete list of possible side effects. If you||
7164|049|S|notice other effects not listed above, contact your doctor or||
7164|050|S|pharmacist.||
7164|051|S|   In the US -||
7164|052|S|   Call your doctor for medical advice about side effects. You||
7164|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7164|054|S|www.fda.gov/medwatch.||
7164|055|S|   In Canada - Call your doctor for medical advice about side||
7164|056|S|effects. You may report side effects to Health Canada at||
7164|057|S|1-866-234-2345.||
7164|058|B|||
7164|059|P|PRECAUTIONS:  Before using ammonium lactate, tell your doctor or||
7164|060|P|pharmacist if you are allergic to it; or if you have any other||
7164|061|P|allergies. This product may contain inactive ingredients, which||
7164|062|P|can cause allergic reactions or other problems. Talk to your||
7164|063|P|pharmacist for more details.||
7164|064|P|   Before using this medication, tell your doctor or pharmacist||
7164|065|P|your medical history, especially of: wounds or sores on the skin.||
7164|066|P|   This medication may make you more sensitive to the sun. Limit||
7164|067|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
7164|068|P|sunscreen and wear protective clothing when outdoors. Tell your||
7164|069|P|doctor right away if you get sunburned or have skin||
7164|070|P|blisters/redness.||
7164|071|P|   During pregnancy, this medication should be used only when||
7164|072|P|clearly needed. Discuss the risks and benefits with your doctor.||
7164|073|P|   It is unknown if this medication passes into breast milk.||
7164|074|P|Consult your doctor before breastfeeding.||
7164|075|B|||
7164|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7164|077|I|medications work or increase your risk for serious side effects.||
7164|078|I|This document does not contain all possible drug interactions.||
7164|079|I|Keep a list of all the products you use (including||
7164|080|I|prescription/nonprescription drugs and herbal products) and share||
7164|081|I|it with your doctor and pharmacist. Do not start, stop, or change||
7164|082|I|the dosage of any medicines without your doctor's approval.||
7164|083|B|||
7164|084|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7164|085|O|has overdosed and has serious symptoms such as passing out or||
7164|086|O|trouble breathing, call 911. Otherwise, call a poison control||
7164|087|O|center right away. US residents can call 1-800-222-1222. Canada||
7164|088|O|residents can call 1-844-764-7669.||
7164|089|B|||
7164|090|N|NOTES:  Do not share this medication with others.||
7164|091|N|   Some ways to help prevent dry skin include using lukewarm (not||
7164|092|N|hot) water when bathing, taking baths/showers less often (such as||
7164|093|N|every 1-2 days), keeping baths/showers short, and using a||
7164|094|N|humidifier when the air is very dry.||
7164|095|B|||
7164|096|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7164|097|D|If it is near the time of the next dose, skip the missed dose.||
7164|098|D|Use your next dose at the regular time. Do not double the dose to||
7164|099|D|catch up.||
7164|100|B|||
7164|101|R|STORAGE:  Store at room temperature. Keep all medications away||
7164|102|R|from children and pets.||
7164|103|R|   Do not flush medications down the toilet or pour them into a||
7164|104|R|drain unless instructed to do so. Properly discard this product||
7164|105|R|when it is expired or no longer needed. Consult your pharmacist||
7164|106|R|or local waste disposal company.||
7164|107|B|||
7164|108|A|Information last revised November 2024.||
7164|109|A|Copyright(c) 2025 First Databank, Inc.||
7164|110|B|||
7168|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7168|002|Z|does NOT have all possible information about this product. This||
7168|003|Z|information does not assure that this product is safe, effective,||
7168|004|Z|or appropriate for you. This information is not individual||
7168|005|Z|medical advice and does not substitute for the advice of your||
7168|006|Z|health care professional. Always ask your health care||
7168|007|Z|professional for complete information about this product and your||
7168|008|Z|specific health needs.||
7168|009|B|||
7168|010|T|METOPROLOL SUCCINATE EXTENDED-RELEASE TABLET - ORAL||
7168|011|F|(MET-oh-PROE-lol SUX-i-nate)||
7168|012|B|||
7168|013|C|COMMON BRAND NAME(S): Toprol XL||
7168|014|B|||
7168|015|W|WARNING:  Do not stop taking this medication without consulting||
7168|016|W|your doctor. Some conditions may become worse when you suddenly||
7168|017|W|stop this drug. Some people who have suddenly stopped taking||
7168|018|W|similar drugs have had chest pain, heart attack, and irregular||
7168|019|W|heartbeat. If your doctor decides you should no longer use this||
7168|020|W|drug, your doctor may direct you to gradually decrease your dose||
7168|021|W|over 1 to 2 weeks.||
7168|022|W|   When gradually stopping this medication, it is recommended||
7168|023|W|that you temporarily limit physical activity to decrease strain||
7168|024|W|on the heart. Get medical help right away if you develop chest||
7168|025|W|pain/tightness/pressure, chest pain spreading to the||
7168|026|W|jaw/neck/arm, unusual sweating, trouble breathing, or||
7168|027|W|fast/irregular heartbeat.||
7168|028|B|||
7168|029|U|USES:  This medication is a beta-blocker used to treat chest pain||
7168|030|U|(angina), heart failure, and high blood pressure. Lowering high||
7168|031|U|blood pressure helps prevent strokes, heart attacks, and kidney||
7168|032|U|problems.||
7168|033|U|   This drug works by blocking the action of certain natural||
7168|034|U|chemicals in your body (such as epinephrine) that affect the||
7168|035|U|heart and blood vessels. This lowers heart rate, blood pressure,||
7168|036|U|and strain on the heart.||
7168|037|B|||
7168|038|V|OTHER USES:  This section contains uses of this drug that are not||
7168|039|V|listed in the approved US professional labeling for the drug but||
7168|040|V|that may be prescribed by your health care professional. Use this||
7168|041|V|drug for a condition that is listed in this section only if it||
7168|042|V|has been so prescribed by your health care professional.||
7168|043|V|   This drug may also be used for irregular heartbeats or after||
7168|044|V|an acute heart attack to improve survival. It may also be used to||
7168|045|V|reduce the risk of migraine headaches.||
7168|046|B|||
7168|047|H|HOW TO USE:  See also Warning section.||
7168|048|H|   Take this medication by mouth as directed by your doctor,||
7168|049|H|usually once daily. This medication may be taken with or without||
7168|050|H|food.||
7168|051|H|   Do not crush or chew extended-release tablets. Doing so can||
7168|052|H|release all of the drug at once, increasing the risk of side||
7168|053|H|effects. Also, do not split extended-release tablets unless they||
7168|054|H|have a score line and your doctor or pharmacist tells you to do||
7168|055|H|so. Swallow the whole or split tablet without crushing or||
7168|056|H|chewing.||
7168|057|H|   To reduce your risk of side effects, your doctor may direct||
7168|058|H|you to start this medication at a low dose and gradually increase||
7168|059|H|your dose. Follow your doctor's instructions carefully. The||
7168|060|H|dosage is based on your medical condition and response to||
7168|061|H|treatment.||
7168|062|H|   Use this medication regularly to get the most benefit from it.||
7168|063|H|To help you remember, take it at the same time each day. Do not||
7168|064|H|suddenly stop taking this medication without consulting your||
7168|065|H|doctor. Your condition may become worse when the drug is suddenly||
7168|066|H|stopped.||
7168|067|H|   For the treatment of high blood pressure, it may take several||
7168|068|H|weeks before you get the full benefit of this drug. Keep taking||
7168|069|H|this medication even if you feel well. Most people with high||
7168|070|H|blood pressure do not feel sick.||
7168|071|H|   To prevent chest pain, a second heart attack, or migraine||
7168|072|H|headaches, it is very important to take this medication regularly||
7168|073|H|as prescribed. This drug should not be used to treat chest pain||
7168|074|H|or migraines when they occur. Use other medications to relieve||
7168|075|H|sudden attacks as directed by your doctor (for example,||
7168|076|H|nitroglycerin tablets placed under the tongue for chest pain,||
7168|077|H|"triptan" drugs such as sumatriptan for migraines). Consult your||
7168|078|H|doctor or pharmacist for details.||
7168|079|H|   Tell your doctor if your condition does not get better or if||
7168|080|H|it gets worse (for example, your blood pressure readings remain||
7168|081|H|high or increase, your chest pain or migraines occur more often).||
7168|082|B|||
7168|083|S|SIDE EFFECTS:  See also Warning section.||
7168|084|S|   Drowsiness, dizziness, tiredness, diarrhea, and slow heartbeat||
7168|085|S|may occur. Decreased sexual ability has been reported rarely. If||
7168|086|S|any of these effects last or get worse, tell your doctor or||
7168|087|S|pharmacist promptly.||
7168|088|S|   To reduce the risk of dizziness and lightheadedness, get up||
7168|089|S|slowly when rising from a sitting or lying position.||
7168|090|S|   With some brands of this medication, an empty tablet shell may||
7168|091|S|appear in your stool. This is harmless.||
7168|092|S|   This drug may reduce blood flow to your hands and feet,||
7168|093|S|causing them to feel cold. Smoking may worsen this effect. Dress||
7168|094|S|warmly and avoid tobacco use.||
7168|095|S|   Remember that this medication has been prescribed because your||
7168|096|S|doctor has judged that the benefit to you is greater than the||
7168|097|S|risk of side effects. Many people using this medication do not||
7168|098|S|have serious side effects.||
7168|099|S|   Tell your doctor right away if you have any serious side||
7168|100|S|effects, including: very slow heartbeat, fainting, blue||
7168|101|S|fingers/toes, new or worsening symptoms of heart failure (such as||
7168|102|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
7168|103|S|unusual/sudden weight gain), mental/mood changes (such as||
7168|104|S|confusion, mood swings, depression).||
7168|105|S|   A very serious allergic reaction to this drug is rare.||
7168|106|S|However, get medical help right away if you notice any symptoms||
7168|107|S|of a serious allergic reaction, including: rash, itching/swelling||
7168|108|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7168|109|S|breathing.||
7168|110|S|   This is not a complete list of possible side effects. If you||
7168|111|S|notice other effects not listed above, contact your doctor or||
7168|112|S|pharmacist.||
7168|113|S|   In the US -||
7168|114|S|   Call your doctor for medical advice about side effects. You||
7168|115|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7168|116|S|www.fda.gov/medwatch.||
7168|117|S|   In Canada - Call your doctor for medical advice about side||
7168|118|S|effects. You may report side effects to Health Canada at||
7168|119|S|1-866-234-2345.||
7168|120|B|||
7168|121|P|PRECAUTIONS:  Before taking metoprolol, tell your doctor or||
7168|122|P|pharmacist if you are allergic to it; or to other beta-blockers||
7168|123|P|(such as atenolol, propranolol); or if you have any other||
7168|124|P|allergies. This product may contain inactive ingredients, which||
7168|125|P|can cause allergic reactions or other problems. Talk to your||
7168|126|P|pharmacist for more details.||
7168|127|P|   Before using this medication, tell your doctor or pharmacist||
7168|128|P|your medical history, especially of: certain types of heart||
7168|129|P|rhythm problems (such as a slow heartbeat, second- or||
7168|130|P|third-degree atrioventricular block, sick sinus syndrome),||
7168|131|P|breathing problems (such as asthma, chronic bronchitis,||
7168|132|P|emphysema), liver disease, serious allergic reactions, including||
7168|133|P|those needing treatment with epinephrine, blood circulation||
7168|134|P|problems (such as Raynaud's disease, peripheral vascular||
7168|135|P|disease), mental/mood disorders (such as depression), a certain||
7168|136|P|muscle disease (myasthenia gravis).||
7168|137|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7168|138|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7168|139|P|machinery, or do anything that needs alertness until you can do||
7168|140|P|it safely. Limit or avoid alcoholic beverages. Talk to your||
7168|141|P|doctor if you are using marijuana (cannabis).||
7168|142|P|   Before having surgery, tell your doctor or dentist about all||
7168|143|P|the products you use (including prescription drugs,||
7168|144|P|nonprescription drugs, and herbal products).||
7168|145|P|   This product may prevent the fast/pounding heartbeat you would||
7168|146|P|usually feel when your blood sugar level falls too low||
7168|147|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
7168|148|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
7168|149|P|blood sugar level, such as dizziness and sweating, are not||
7168|150|P|affected by this drug.||
7168|151|P|   If you have diabetes, this product may make it harder to||
7168|152|P|control your blood sugar levels. Check your blood sugar levels||
7168|153|P|regularly as directed by your doctor. Tell your doctor right away||
7168|154|P|if you have symptoms of high blood sugar such as increased||
7168|155|P|thirst/urination. Your doctor may need to adjust your diabetes||
7168|156|P|medication, exercise program, or diet.||
7168|157|P|   Children may be at greater risk for low blood sugar||
7168|158|P|(hypoglycemia) while using this drug, especially if they are||
7168|159|P|vomiting or not eating regularly. To help prevent low blood||
7168|160|P|sugar, make sure children eat regularly. If your child cannot eat||
7168|161|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
7168|162|P|as sweating, shaking), tell the doctor right away.||
7168|163|P|   During pregnancy, this medication should be used only when||
7168|164|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
7168|165|P|benefits with your doctor.||
7168|166|P|   This drug passes into breast milk but is unlikely to harm a||
7168|167|P|nursing infant. Consult your doctor before breastfeeding.||
7168|168|B|||
7168|169|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7168|170|I|medications work or increase your risk for serious side effects.||
7168|171|I|This document does not contain all possible drug interactions.||
7168|172|I|Keep a list of all the products you use (including||
7168|173|I|prescription/nonprescription drugs and herbal products) and share||
7168|174|I|it with your doctor and pharmacist. Do not start, stop, or change||
7168|175|I|the dosage of any medicines without your doctor's approval.||
7168|176|I|   A product that may interact with this drug is: fingolimod.||
7168|177|I|   Other medications can affect the removal of metoprolol from||
7168|178|I|your body, which may affect how metoprolol works. Examples||
7168|179|I|include lumefantrine, propafenone, quinidine, SSRI||
7168|180|I|antidepressants (such as fluoxetine, paroxetine), St. John's||
7168|181|I|wort, among others.||
7168|182|I|   Some products have ingredients that could raise your heart||
7168|183|I|rate or blood pressure or worsen your heart failure. Tell your||
7168|184|I|pharmacist what products you are using, and ask how to use them||
7168|185|I|safely (especially cough-and-cold products, diet aids, or NSAIDs||
7168|186|I|such as ibuprofen/naproxen).||
7168|187|B|||
7168|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7168|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7168|190|O|poison control center right away. US residents can call||
7168|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7168|192|O|Symptoms of overdose may include: very slow heartbeat, severe||
7168|193|O|dizziness, severe weakness, fainting, trouble breathing.||
7168|194|B|||
7168|195|N|NOTES:  Do not share this medication with others.||
7168|196|N|   Talk with your doctor about lifestyle changes that may help||
7168|197|N|this medication work better (such as stress reduction programs,||
7168|198|N|exercise, and dietary changes).||
7168|199|N|   Have your blood pressure and pulse (heart rate) checked||
7168|200|N|regularly while taking this medication. Learn how to check your||
7168|201|N|own blood pressure and pulse at home, and share the results with||
7168|202|N|your doctor.||
7168|203|N|   Lab and/or medical tests (such as liver function) should be||
7168|204|N|done while you are taking this medication. Consult your doctor||
7168|205|N|for more details.||
7168|206|B|||
7168|207|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7168|208|D|remember. If it is near the time of the next dose, skip the||
7168|209|D|missed dose. Take your next dose at the regular time. Do not||
7168|210|D|double the dose to catch up.||
7168|211|B|||
7168|212|R|STORAGE:  Store at room temperature away from light and moisture.||
7168|213|R|Do not store in the bathroom. Keep all medications away from||
7168|214|R|children and pets.||
7168|215|R|   Do not flush medications down the toilet or pour them into a||
7168|216|R|drain unless instructed to do so. Properly discard this product||
7168|217|R|when it is expired or no longer needed. Consult your pharmacist||
7168|218|R|or local waste disposal company.||
7168|219|B|||
7168|220|M|MEDICAL ALERT:  Your condition can cause complications in a||
7168|221|M|medical emergency. For information about enrolling in MedicAlert,||
7168|222|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7168|223|B|||
7168|224|A|Information last revised January 2025.||
7168|225|A|Copyright(c) 2025 First Databank, Inc.||
7168|226|B|||
7170|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7170|002|Z|does NOT have all possible information about this product. This||
7170|003|Z|information does not assure that this product is safe, effective,||
7170|004|Z|or appropriate for you. This information is not individual||
7170|005|Z|medical advice and does not substitute for the advice of your||
7170|006|Z|health care professional. Always ask your health care||
7170|007|Z|professional for complete information about this product and your||
7170|008|Z|specific health needs.||
7170|009|B|||
7170|010|T|PRAMOXINE/HYDROCORTISONE - TOPICAL||
7170|011|F|(pram-OX-een/hi-dro-KOR-tih-sown)||
7170|012|B|||
7170|013|C|COMMON BRAND NAME(S): Pramosone||
7170|014|B|||
7170|015|U|USES:  Pramoxine is an anesthetic used on the skin to relieve||
7170|016|U|minor pain, itching, and discomfort. Hydrocortisone is a||
7170|017|U|corticosteroid that reduces redness, swelling, and itching. This||
7170|018|U|combination medication is used to treat certain skin conditions||
7170|019|U|such as eczema, rash, scrapes, insect bites, or minor burns.||
7170|020|U|   This combination product for the skin is available in||
7170|021|U|different strengths and forms (such as creams, ointments, and||
7170|022|U|gels). The type of medication used depends on the location of||
7170|023|U|your condition and the type of skin problem being treated. Creams||
7170|024|U|are the most often used form. Ointments may be better suited for||
7170|025|U|dry areas and when a stronger effect or skin protection is||
7170|026|U|desired. Gels may be more drying.||
7170|027|B|||
7170|028|H|HOW TO USE:  Before applying the medication, clean the affected||
7170|029|H|area with mild soap and water, rinse well, and pat dry. Gently||
7170|030|H|rub a small amount of the medication into the affected area and||
7170|031|H|surrounding skin in a thin layer as directed by your doctor,||
7170|032|H|usually 3 to 4 times a day. How often the medication is applied||
7170|033|H|and for how long depends on your condition and response to||
7170|034|H|treatment.||
7170|035|H|   Wash hands immediately after use unless the area being treated||
7170|036|H|includes the hands. Avoid getting the product in your eyes, nose,||
7170|037|H|ears, or mouth. If the medication gets in these areas, rinse||
7170|038|H|immediately with clean water.||
7170|039|H|   Do not cover the area with waterproof bandages or plastic,||
7170|040|H|apply heat, or use the product on large areas of the body unless||
7170|041|H|directed to do so by your doctor. If used in the diaper area on||
7170|042|H|an infant, do not use tight-fitting diapers or plastic pants.||
7170|043|H|These may increase the risk of side effects.||
7170|044|H|   Use this medication regularly in order to get the most benefit||
7170|045|H|from it. To help you remember, use it at the same times each day.||
7170|046|H|   Do not use more of this product, use it more often, or keep||
7170|047|H|using it longer than prescribed by your doctor. If you have been||
7170|048|H|using this medication for a long time or in high doses, do not||
7170|049|H|suddenly stop using it without your doctor's approval. Some||
7170|050|H|conditions may become worse when this drug is suddenly stopped.||
7170|051|H|Your dose may need to be gradually decreased.||
7170|052|H|   Tell your doctor if your condition does not get better or if||
7170|053|H|it gets worse.||
7170|054|B|||
7170|055|S|SIDE EFFECTS:  Redness, burning, dryness, or itching at the||
7170|056|S|application site may occur. If any of these effects last or get||
7170|057|S|worse, tell your doctor or pharmacist promptly.||
7170|058|S|   Remember that this medication has been prescribed because your||
7170|059|S|doctor has judged that the benefit to you is greater than the||
7170|060|S|risk of side effects. Many people using this medication do not||
7170|061|S|have serious side effects.||
7170|062|S|   Tell your doctor right away if you have any serious side||
7170|063|S|effects, including: change in skin appearance (such as color,||
7170|064|S|thickness), signs of skin infection (such as heat, tenderness,||
7170|065|S|pus), signs of infection (such as sore throat that doesn't go||
7170|066|S|away, fever, chills).||
7170|067|S|   A very serious allergic reaction to this drug is rare.||
7170|068|S|However, get medical help right away if you notice any symptoms||
7170|069|S|of a serious allergic reaction, including: rash, itching/swelling||
7170|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7170|071|S|breathing.||
7170|072|S|   This is not a complete list of possible side effects. If you||
7170|073|S|notice other effects not listed above, contact your doctor or||
7170|074|S|pharmacist.||
7170|075|S|   In the US -||
7170|076|S|   Call your doctor for medical advice about side effects. You||
7170|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7170|078|S|www.fda.gov/medwatch.||
7170|079|S|   In Canada - Call your doctor for medical advice about side||
7170|080|S|effects. You may report side effects to Health Canada at||
7170|081|S|1-866-234-2345.||
7170|082|B|||
7170|083|P|PRECAUTIONS:  Before using this product, tell your doctor or||
7170|084|P|pharmacist if you are allergic to pramoxine; or to||
7170|085|P|hydrocortisone; or if you have any other allergies. This product||
7170|086|P|may contain inactive ingredients, which can cause allergic||
7170|087|P|reactions or other problems. Talk to your pharmacist for more||
7170|088|P|details.||
7170|089|P|   Before using this medication, tell your doctor or pharmacist||
7170|090|P|your medical history, especially of: diabetes, eye problems,||
7170|091|P|infections (especially skin infections), liver disease.||
7170|092|P|   Children may be more sensitive to the effects of too much||
7170|093|P|corticosteroid medication. Consult your doctor for more details.||
7170|094|P|   During pregnancy, this medication should be used only when||
7170|095|P|clearly needed. It should not be used for long periods of time or||
7170|096|P|in large amounts. Discuss the risks and benefits with your||
7170|097|P|doctor.||
7170|098|P|   It is unknown if this medication passes into breast milk.||
7170|099|P|Consult your doctor before breastfeeding.||
7170|100|B|||
7170|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7170|102|I|medications work or increase your risk for serious side effects.||
7170|103|I|This document does not contain all possible drug interactions.||
7170|104|I|Keep a list of all the products you use (including||
7170|105|I|prescription/nonprescription drugs and herbal products) and share||
7170|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
7170|107|I|the dosage of any medicines without your doctor's approval.||
7170|108|B|||
7170|109|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7170|110|O|has overdosed and has serious symptoms such as passing out or||
7170|111|O|trouble breathing, call 911. Otherwise, call a poison control||
7170|112|O|center right away. US residents can call 1-800-222-1222. Canada||
7170|113|O|residents can call 1-844-764-7669.||
7170|114|B|||
7170|115|N|NOTES:  Do not share this medication with others.||
7170|116|N|   Use this medication for your current condition only. Do not||
7170|117|N|use it later for other skin problems unless told to do so by your||
7170|118|N|doctor. A different medication may be necessary in those cases.||
7170|119|B|||
7170|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7170|121|D|If it is near the time of the next dose, skip the missed dose.||
7170|122|D|Use your next dose at the regular time. Do not double the dose to||
7170|123|D|catch up.||
7170|124|B|||
7170|125|R|STORAGE:  Store at room temperature. Keep all medications away||
7170|126|R|from children and pets.||
7170|127|R|   Do not flush medications down the toilet or pour them into a||
7170|128|R|drain unless instructed to do so. Properly discard this product||
7170|129|R|when it is expired or no longer needed. Consult your pharmacist||
7170|130|R|or local waste disposal company.||
7170|131|B|||
7170|132|A|Information last revised May 2025.||
7170|133|A|Copyright(c) 2025 First Databank, Inc.||
7170|134|B|||
7171|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7171|002|Z|does NOT have all possible information about this product. This||
7171|003|Z|information does not assure that this product is safe, effective,||
7171|004|Z|or appropriate for you. This information is not individual||
7171|005|Z|medical advice and does not substitute for the advice of your||
7171|006|Z|health care professional. Always ask your health care||
7171|007|Z|professional for complete information about this product and your||
7171|008|Z|specific health needs.||
7171|009|B|||
7171|010|T|ACETIC ACID - OTIC||
7171|011|F|(a-SEE-tik AS-id)||
7171|012|B|||
7171|013|C|COMMON BRAND NAME(S): Vosol||
7171|014|B|||
7171|015|U|USES:  Acetic acid is used to treat an outer ear infection||
7171|016|U|(external otitis). It works by stopping the growth of bacteria||
7171|017|U|and fungus. Treating the infection reduces pain and swelling in||
7171|018|U|the ear. Wetness in the ear canal can help bacteria and fungus to||
7171|019|U|grow. This medication may also contain drying ingredients such as||
7171|020|U|glycerin or alcohol. Drying of the ear canal helps to cure the||
7171|021|U|infection.||
7171|022|B|||
7171|023|H|HOW TO USE:  Use this medication in the affected ear(s) as||
7171|024|H|directed by your doctor, usually 3 to 4 times daily. Use in the||
7171|025|H|ear only. Do not use in the eyes, swallow, inject, or inhale the||
7171|026|H|medication.||
7171|027|H|   Before giving this medication, thoroughly clean the ear canal||
7171|028|H|as directed, and remove any crust or other material. Then wash||
7171|029|H|your hands.||
7171|030|H|   To make sure that the right amount of medication is given, and||
7171|031|H|to avoid touching the ear with the dropper, have another person||
7171|032|H|insert the drops if possible. To lower the risk of dizziness,||
7171|033|H|hold the container in your hand for a few minutes in order to||
7171|034|H|warm it.||
7171|035|H|   To avoid contamination, do not touch the dropper tip or let it||
7171|036|H|touch your ear or any other surface. Lie on your side or tilt the||
7171|037|H|affected ear upward. Hold the dropper directly over the ear, and||
7171|038|H|place the prescribed number of drops into the ear canal. To help||
7171|039|H|the drops roll into the ear of an adult, hold the earlobe up and||
7171|040|H|back. In children, hold the earlobe down and back. Keep the head||
7171|041|H|tilted for about 2 minutes, or insert a piece of cotton if your||
7171|042|H|doctor directs you to do so to keep the medication in contact||
7171|043|H|with your ear canal. Repeat for the other ear if so directed. Do||
7171|044|H|not rinse the dropper. Replace the cap after use.||
7171|045|H|   Dosage is based on your medical condition and response to||
7171|046|H|treatment.||
7171|047|H|   Use this medication regularly to get the most benefit from it.||
7171|048|H|To help you remember, use it at the same times each day. Continue||
7171|049|H|to use this medication for the full time prescribed, even if||
7171|050|H|symptoms disappear after a few days. Stopping the medication too||
7171|051|H|early may result in a return of the infection.||
7171|052|H|   Tell your doctor if your ear symptoms last, get worse, or||
7171|053|H|return after stopping this medication.||
7171|054|H|   Avoid contact with the eyes. If you get some of the medication||
7171|055|H|in the eye, rinse the eye with a steady, gentle stream of tap||
7171|056|H|water for at least 15 minutes. Tell your doctor if the eye||
7171|057|H|irritation doesn't go away or your vision is decreased.||
7171|058|B|||
7171|059|S|SIDE EFFECTS:  Temporary stinging/burning in the ear canal may||
7171|060|S|occur. If this effect lasts or gets worse, tell your doctor or||
7171|061|S|pharmacist promptly.||
7171|062|S|   Remember that this medication has been prescribed because your||
7171|063|S|doctor has judged that the benefit to you is greater than the||
7171|064|S|risk of side effects. Many people using this medication do not||
7171|065|S|have serious side effects.||
7171|066|S|   Tell your doctor right away if you have any serious side||
7171|067|S|effects, including: increased or new redness/swelling/pain in or||
7171|068|S|around the ears.||
7171|069|S|   A very serious allergic reaction to this drug is rare.||
7171|070|S|However, get medical help right away if you notice any symptoms||
7171|071|S|of a serious allergic reaction, including: rash, itching/swelling||
7171|072|S|(especially of the ear/face/tongue/throat), severe dizziness,||
7171|073|S|trouble breathing.||
7171|074|S|   This is not a complete list of possible side effects. If you||
7171|075|S|notice other effects not listed above, contact your doctor or||
7171|076|S|pharmacist.||
7171|077|S|   In the US -||
7171|078|S|   Call your doctor for medical advice about side effects. You||
7171|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7171|080|S|www.fda.gov/medwatch.||
7171|081|S|   In Canada - Call your doctor for medical advice about side||
7171|082|S|effects. You may report side effects to Health Canada at||
7171|083|S|1-866-234-2345.||
7171|084|B|||
7171|085|P|PRECAUTIONS:  Before using acetic acid, tell your doctor or||
7171|086|P|pharmacist if you are allergic to it; or if you have any other||
7171|087|P|allergies. This product may contain inactive ingredients, which||
7171|088|P|can cause allergic reactions or other problems. Talk to your||
7171|089|P|pharmacist for more details.||
7171|090|P|   Before using this medication, tell your doctor or pharmacist||
7171|091|P|your medical history.||
7171|092|P|   Before having surgery, tell your doctor or dentist about all||
7171|093|P|the products you use (including prescription drugs,||
7171|094|P|nonprescription drugs, and herbal products).||
7171|095|P|   During pregnancy, this medication should be used only when||
7171|096|P|clearly needed. Though the risks are probably small, discuss the||
7171|097|P|use of this medication with your doctor.||
7171|098|P|   It is unknown if this medication passes into breast milk.||
7171|099|P|Consult your doctor before breastfeeding.||
7171|100|B|||
7171|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7171|102|I|medications work or increase your risk for serious side effects.||
7171|103|I|This document does not contain all possible drug interactions.||
7171|104|I|Keep a list of all the products you use (including||
7171|105|I|prescription/nonprescription drugs and herbal products) and share||
7171|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
7171|107|I|the dosage of any medicines without your doctor's approval.||
7171|108|B|||
7171|109|O|OVERDOSE:  Overdose with this medication is unlikely even if||
7171|110|O|swallowed. However, if someone has overdosed and has serious||
7171|111|O|symptoms such as passing out or trouble breathing, call 911.||
7171|112|O|Otherwise, call a poison control center right away. US residents||
7171|113|O|can call 1-800-222-1222. Canada residents can call||
7171|114|O|1-844-764-7669.||
7171|115|B|||
7171|116|N|NOTES:  Do not share this medication with others.||
7171|117|N|   This medication has been prescribed for your current condition||
7171|118|N|only. Do not use it later for another ear problem unless told to||
7171|119|N|do so by your doctor. A different medication may be necessary in||
7171|120|N|that case.||
7171|121|N|   For certain ear problems, it is important to keep the affected||
7171|122|N|ear(s) clean and dry. Try not to get the affected ear(s) wet when||
7171|123|N|bathing. Avoid swimming unless your doctor tells you otherwise.||
7171|124|N|Consult your doctor for more details.||
7171|125|B|||
7171|126|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7171|127|D|If it is near the time of the next dose, skip the missed dose.||
7171|128|D|Use your next dose at the regular time. Do not double the dose to||
7171|129|D|catch up.||
7171|130|B|||
7171|131|R|STORAGE:  Store at room temperature. Keep all medications away||
7171|132|R|from children and pets.||
7171|133|R|   Do not flush medications down the toilet or pour them into a||
7171|134|R|drain unless instructed to do so. Properly discard this product||
7171|135|R|when it is expired or no longer needed. Consult your pharmacist||
7171|136|R|or local waste disposal company.||
7171|137|B|||
7171|138|A|Information last revised May 2024.||
7171|139|A|Copyright(c) 2025 First Databank, Inc.||
7171|140|B|||
7173|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7173|002|Z|does NOT have all possible information about this product. This||
7173|003|Z|information does not assure that this product is safe, effective,||
7173|004|Z|or appropriate for you. This information is not individual||
7173|005|Z|medical advice and does not substitute for the advice of your||
7173|006|Z|health care professional. Always ask your health care||
7173|007|Z|professional for complete information about this product and your||
7173|008|Z|specific health needs.||
7173|009|B|||
7173|010|T|TETRAHYDROZOLINE - OPHTHALMIC||
7173|011|F|(TEH-truh-hi-DROZE-oh-leen)||
7173|012|B|||
7173|013|C|COMMON BRAND NAME(S): Opti-Clear, Visine||
7173|014|B|||
7173|015|U|USES:  Tetrahydrozoline is a decongestant used to relieve redness||
7173|016|U|in the eyes caused by minor eye irritations (such as smog,||
7173|017|U|swimming, dust, or smoke). It belongs to a class of drugs known||
7173|018|U|as sympathomimetic amines. It works by temporarily narrowing the||
7173|019|U|blood vessels in the eye.||
7173|020|U|   Some brands of tetrahydrozoline eye drops may contain||
7173|021|U|lubricants. Lubricants help protect the eyes from more irritation||
7173|022|U|and dryness.||
7173|023|B|||
7173|024|H|HOW TO USE:  Use this medication in the affected eye(s) as||
7173|025|H|directed by your doctor, usually up to 4 times a day as needed.||
7173|026|H|   Follow all directions on the product package, or use as||
7173|027|H|directed by your doctor. If you have any questions, ask your||
7173|028|H|doctor or pharmacist.||
7173|029|H|   To apply eye drops, wash your hands first. To avoid||
7173|030|H|contamination, do not touch the dropper tip or let it touch your||
7173|031|H|eye or any other surface. Remove contact lenses before applying||
7173|032|H|the eye drops. Wait at least 10 minutes after using this||
7173|033|H|medication before inserting contact lenses.||
7173|034|H|   Before using, check this product for cloudiness or||
7173|035|H|discoloration. If either is present, do not use the liquid.||
7173|036|H|   Tilt your head back, look upward, and pull down the lower||
7173|037|H|eyelid to make a pouch. Hold the dropper directly over the eye||
7173|038|H|and place 1 drop into the pouch. Look downward and gently close||
7173|039|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
7173|040|H|the eye near the nose and apply gentle pressure. This will||
7173|041|H|prevent the medication from draining away from the eye. Try not||
7173|042|H|to blink and do not rub the eye. Repeat these steps if your dose||
7173|043|H|is for more than 1 drop and for the other eye if so directed.||
7173|044|H|   Do not rinse the dropper. Replace the dropper cap tightly||
7173|045|H|after each use. If you are using another kind of eye medication||
7173|046|H|(such as drops or ointments), wait at least 5 minutes before||
7173|047|H|applying other medications. Use eye drops before eye ointments to||
7173|048|H|allow the eye drops to enter the eye.||
7173|049|H|   Wait several minutes for your vision to clear before driving||
7173|050|H|or operating machinery.||
7173|051|H|   Overuse of this type of medication may result in increased eye||
7173|052|H|redness (rebound effect when drug wears off). If this occurs,||
7173|053|H|tell your doctor. Do not use this medication for longer than 3 to||
7173|054|H|4 days at a time.||
7173|055|H|   If your condition lasts or gets worse after 72 hours, or if||
7173|056|H|you think you may have a serious medical problem, stop using this||
7173|057|H|medication and get medical help right away.||
7173|058|B|||
7173|059|S|SIDE EFFECTS:  Stinging/redness in the eye, widened pupils, or||
7173|060|S|blurred vision may occur. If any of these effects last or get||
7173|061|S|worse, tell your doctor or pharmacist promptly.||
7173|062|S|   If your doctor has directed you to use this medication,||
7173|063|S|remember that your doctor has judged that the benefit to you is||
7173|064|S|greater than the risk of side effects. Many people using this||
7173|065|S|medication do not have serious side effects.||
7173|066|S|   Tell your doctor right away if you have any serious side||
7173|067|S|effects, including: eye pain, worsening redness/itching/swelling||
7173|068|S|in or around the eyes, other vision problems, shakiness (tremor),||
7173|069|S|fast/pounding/ irregular heartbeat, headache, sweating, weakness,||
7173|070|S|nervousness.||
7173|071|S|   A very serious allergic reaction to this drug is rare.||
7173|072|S|However, get medical help right away if you notice any symptoms||
7173|073|S|of a serious allergic reaction, including: rash, itching/swelling||
7173|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7173|075|S|breathing.||
7173|076|S|   This is not a complete list of possible side effects. If you||
7173|077|S|notice other effects not listed above, contact your doctor or||
7173|078|S|pharmacist.||
7173|079|S|   In the US -||
7173|080|S|   Call your doctor for medical advice about side effects. You||
7173|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7173|082|S|www.fda.gov/medwatch.||
7173|083|S|   In Canada - Call your doctor for medical advice about side||
7173|084|S|effects. You may report side effects to Health Canada at||
7173|085|S|1-866-234-2345.||
7173|086|B|||
7173|087|P|PRECAUTIONS:  Before using tetrahydrozoline, tell your doctor or||
7173|088|P|pharmacist if you are allergic to it; or if you have any other||
7173|089|P|allergies. This product may contain inactive ingredients (such as||
7173|090|P|preservatives like benzalkonium chloride), which can cause||
7173|091|P|allergic reactions or other problems. Talk to your pharmacist for||
7173|092|P|more details.||
7173|093|P|   Before using this medication, tell your doctor or pharmacist||
7173|094|P|your medical history, especially of: glaucoma, heart problems||
7173|095|P|(such as heart attack, chest pain), high blood pressure,||
7173|096|P|diabetes, eye infection/injury, overactive thyroid||
7173|097|P|(hyperthyroidism).||
7173|098|P|   After you apply this drug, your vision may become temporarily||
7173|099|P|blurred. Do not drive, use machinery, or do anything that needs||
7173|100|P|clear vision until you can do it safely.||
7173|101|P|   During pregnancy, this medication should be used only when||
7173|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
7173|103|P|   It is unknown if this drug passes into breast milk. Consult||
7173|104|P|your doctor before breastfeeding.||
7173|105|B|||
7173|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7173|107|I|medications work or increase your risk for serious side effects.||
7173|108|I|This document does not contain all possible drug interactions.||
7173|109|I|Keep a list of all the products you use (including||
7173|110|I|prescription/nonprescription drugs and herbal products) and share||
7173|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
7173|112|I|the dosage of any medicines without your doctor's approval.||
7173|113|B|||
7173|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7173|115|O|has overdosed and has serious symptoms such as passing out or||
7173|116|O|trouble breathing, call 911. Otherwise, call a poison control||
7173|117|O|center right away. US residents can call 1-800-222-1222. Canada||
7173|118|O|residents can call 1-844-764-7669. Symptoms of overdose may||
7173|119|O|include drowsiness, severe sweating, decreased body temperature,||
7173|120|O|slow/shallow breathing.||
7173|121|B|||
7173|122|N|NOTES:  If your symptoms are due to allergies, avoid allergens||
7173|123|N|that may be the cause of your symptoms. Some common causes of||
7173|124|N|allergies include pollen, grasses, weeds, dust mites, and pet||
7173|125|N|dander.||
7173|126|B|||
7173|127|D|MISSED DOSE:  If your doctor has directed you to use this||
7173|128|D|medication on a regular schedule and you miss a dose, use it as||
7173|129|D|soon as you remember. If it is near the time of the next dose,||
7173|130|D|skip the missed dose. Use your next dose at the regular time. Do||
7173|131|D|not double the dose to catch up.||
7173|132|B|||
7173|133|R|STORAGE:  Store at room temperature away from light. Keep all||
7173|134|R|medications away from children and pets.||
7173|135|R|   Do not flush medications down the toilet or pour them into a||
7173|136|R|drain unless instructed to do so. Properly discard this product||
7173|137|R|when it is expired or no longer needed. Consult your pharmacist||
7173|138|R|or local waste disposal company.||
7173|139|B|||
7173|140|A|Information last revised November 2024.||
7173|141|A|Copyright(c) 2025 First Databank, Inc.||
7173|142|B|||
7174|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7174|002|Z|does NOT have all possible information about this product. This||
7174|003|Z|information does not assure that this product is safe, effective,||
7174|004|Z|or appropriate for you. This information is not individual||
7174|005|Z|medical advice and does not substitute for the advice of your||
7174|006|Z|health care professional. Always ask your health care||
7174|007|Z|professional for complete information about this product and your||
7174|008|Z|specific health needs.||
7174|009|B|||
7174|010|T|ALENDRONATE - ORAL||
7174|011|F|(a-LEN-droe-nate)||
7174|012|B|||
7174|013|C|COMMON BRAND NAME(S): Fosamax||
7174|014|B|||
7174|015|U|USES:  Alendronate is used to prevent and treat certain types of||
7174|016|U|bone loss (osteoporosis) in adults. Osteoporosis causes bones to||
7174|017|U|become thinner and break more easily. Your chance of developing||
7174|018|U|osteoporosis increases as you age, after menopause, or if you are||
7174|019|U|taking corticosteroid medications (such as prednisone) for a long||
7174|020|U|time.||
7174|021|U|   This medication works by slowing bone loss. This effect helps||
7174|022|U|maintain strong bones and reduce the risk of broken bones||
7174|023|U|(fractures). Alendronate belongs to a class of drugs called||
7174|024|U|bisphosphonates.||
7174|025|B|||
7174|026|H|HOW TO USE:  Read the Medication Guide provided by your||
7174|027|H|pharmacist before you start taking alendronate and each time you||
7174|028|H|get a refill. Follow the instructions very closely to make sure||
7174|029|H|your body absorbs as much drug as possible and to reduce the risk||
7174|030|H|of injury to your esophagus. If you have any questions, ask your||
7174|031|H|doctor or pharmacist.||
7174|032|H|   Take this medication by mouth as directed by your doctor,||
7174|033|H|usually once a day. Take this medication after getting up for the||
7174|034|H|day and before taking your first food, beverage, or other||
7174|035|H|medication. Take it with a full glass (6-8 ounces or 180-240||
7174|036|H|milliliters) of plain water. Swallow the tablet whole. Do not||
7174|037|H|chew or suck on it. Then stay fully upright (sitting, standing,||
7174|038|H|or walking) for at least 30 minutes and do not lie down until||
7174|039|H|after your first food of the day. Alendronate works only if taken||
7174|040|H|on an empty stomach. Wait at least 30 minutes (preferably 1 to 2||
7174|041|H|hours) after taking the medication before you eat or drink||
7174|042|H|anything other than plain water.||
7174|043|H|   Do not take this medication at bedtime or before rising for||
7174|044|H|the day. It may not be absorbed and you may have side effects.||
7174|045|H|   Calcium or iron supplements, vitamins, antacids, coffee, tea,||
7174|046|H|soda, mineral water, juice with added calcium, and food can||
7174|047|H|decrease the absorption of alendronate. Do not take these for at||
7174|048|H|least 30 minutes (preferably 1 to 2 hours) after taking||
7174|049|H|alendronate.||
7174|050|H|   Take this medication regularly to get the most benefit from||
7174|051|H|it. Remember to use it at the same time each morning. Talk to||
7174|052|H|your doctor about the risks and benefits of long-term use of this||
7174|053|H|medication.||
7174|054|B|||
7174|055|S|SIDE EFFECTS:  Stomach pain, constipation, diarrhea, gas, or||
7174|056|S|nausea may occur. If any of these effects last or get worse, tell||
7174|057|S|your doctor or pharmacist promptly.||
7174|058|S|   Remember that this medication has been prescribed because your||
7174|059|S|doctor has judged that the benefit to you is greater than the||
7174|060|S|risk of side effects. Many people using this medication do not||
7174|061|S|have serious side effects.||
7174|062|S|   Tell your doctor right away if you have any serious side||
7174|063|S|effects, including: jaw/ear pain, increased or severe||
7174|064|S|bone/joint/muscle pain, new or unusual hip/thigh/groin pain,||
7174|065|S|swelling of joints/hands/ankles/feet, black/tarry stools, vomit||
7174|066|S|that looks like coffee grounds.||
7174|067|S|   This medication may rarely cause serious irritation and ulcers||
7174|068|S|of the esophagus. If you notice any of the following unlikely but||
7174|069|S|very serious side effects, stop taking alendronate and talk to||
7174|070|S|your doctor or pharmacist right away: new or worsening heartburn,||
7174|071|S|chest pain, pain or difficulty when swallowing.||
7174|072|S|   A very serious allergic reaction to this drug is rare.||
7174|073|S|However, get medical help right away if you notice any symptoms||
7174|074|S|of a serious allergic reaction, including: rash, itching/swelling||
7174|075|S|(especially of the face/tongue/throat), dizziness, trouble||
7174|076|S|breathing.||
7174|077|S|   This is not a complete list of possible side effects. If you||
7174|078|S|notice other effects not listed above, contact your doctor or||
7174|079|S|pharmacist.||
7174|080|S|   In the US -||
7174|081|S|   Call your doctor for medical advice about side effects. You||
7174|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7174|083|S|www.fda.gov/medwatch.||
7174|084|S|   In Canada - Call your doctor for medical advice about side||
7174|085|S|effects. You may report side effects to Health Canada at||
7174|086|S|1-866-234-2345.||
7174|087|B|||
7174|088|P|PRECAUTIONS:  Before taking alendronate, tell your doctor or||
7174|089|P|pharmacist if you are allergic to it; or to other||
7174|090|P|bisphosphonates; or if you have any other allergies. This product||
7174|091|P|may contain inactive ingredients, which can cause allergic||
7174|092|P|reactions or other problems. Talk to your pharmacist for more||
7174|093|P|details.||
7174|094|P|   Before using this medication, tell your doctor or pharmacist||
7174|095|P|your medical history, especially of: disorders of the esophagus||
7174|096|P|(such as esophageal stricture or achalasia), trouble swallowing,||
7174|097|P|trouble standing or sitting upright for at least 30 minutes, low||
7174|098|P|calcium levels, kidney problems, stomach/intestinal disorders||
7174|099|P|(such as ulcers).||
7174|100|P|   Some people taking alendronate may have serious jawbone||
7174|101|P|problems. Your doctor should check your mouth before you start||
7174|102|P|this medication. Tell your dentist that you are taking this||
7174|103|P|medication before you have any dental work done. To help prevent||
7174|104|P|jawbone problems, have regular dental exams and learn how to keep||
7174|105|P|your teeth and gums healthy. If you have jaw pain, tell your||
7174|106|P|doctor and dentist right away.||
7174|107|P|   Before having any surgery (especially dental procedures), tell||
7174|108|P|your doctor and dentist about this medication and all other||
7174|109|P|products you use (including prescription drugs, nonprescription||
7174|110|P|drugs, and herbal products). Your doctor or dentist may tell you||
7174|111|P|to stop taking alendronate before your surgery. Follow all||
7174|112|P|instructions about stopping or starting this medication.||
7174|113|P|   This drug is not recommended for use in children. Studies have||
7174|114|P|shown that many children who took this drug had severe side||
7174|115|P|effects such as vomiting, fever, and flu-like symptoms.||
7174|116|P|   Tell your doctor if you are pregnant or plan to become||
7174|117|P|pregnant. Alendronate may stay in your body for many years. You||
7174|118|P|should not become pregnant while using alendronate. Discuss the||
7174|119|P|risks and benefits with your doctor.||
7174|120|P|   It is unknown if this medication passes into breast milk.||
7174|121|P|Consult your doctor before breastfeeding.||
7174|122|B|||
7174|123|I|DRUG INTERACTIONS:  See also How to Use section.||
7174|124|I|   Drug interactions may change how your medications work or||
7174|125|I|increase your risk for serious side effects. This document does||
7174|126|I|not contain all possible drug interactions. Keep a list of all||
7174|127|I|the products you use (including prescription/nonprescription||
7174|128|I|drugs and herbal products) and share it with your doctor and||
7174|129|I|pharmacist. Do not start, stop, or change the dosage of any||
7174|130|I|medicines without your doctor's approval.||
7174|131|B|||
7174|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7174|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7174|134|O|poison control center right away. US residents can call||
7174|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7174|136|O|Symptoms of overdose may include: severe stomach pain, painful||
7174|137|O|heartburn, pain in the esophagus (chest pain), muscle||
7174|138|O|weakness/cramps, mental/mood changes.||
7174|139|B|||
7174|140|N|NOTES:  Do not share this medication with others.||
7174|141|N|   Lifestyle changes that help promote healthy bones include||
7174|142|N|increasing weight-bearing exercise, stopping smoking, limiting||
7174|143|N|alcohol, and eating well-balanced meals that contain adequate||
7174|144|N|calcium and vitamin D. You may also need to take calcium and||
7174|145|N|vitamin D supplements. Consult your doctor for specific advice.||
7174|146|N|   Lab and/or medical tests (X-rays, height measurement, blood||
7174|147|N|mineral levels) should be done while you are taking this||
7174|148|N|medication. Keep all medical and lab appointments. Consult your||
7174|149|N|doctor for more details.||
7174|150|B|||
7174|151|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
7174|152|D|next dose at the regular time the following day. Do not double||
7174|153|D|the dose to catch up.||
7174|154|B|||
7174|155|R|STORAGE:  Store at room temperature away from light and moisture.||
7174|156|R|Do not store in the bathroom. Keep all medications away from||
7174|157|R|children and pets.||
7174|158|R|   Do not flush medications down the toilet or pour them into a||
7174|159|R|drain unless instructed to do so. Properly discard this product||
7174|160|R|when it is expired or no longer needed. Consult your pharmacist||
7174|161|R|or local waste disposal company.||
7174|162|B|||
7174|163|A|Information last revised September 2025.||
7174|164|A|Copyright(c) 2025 First Databank, Inc.||
7174|165|B|||
7177|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7177|002|Z|does NOT have all possible information about this product. This||
7177|003|Z|information does not assure that this product is safe, effective,||
7177|004|Z|or appropriate for you. This information is not individual||
7177|005|Z|medical advice and does not substitute for the advice of your||
7177|006|Z|health care professional. Always ask your health care||
7177|007|Z|professional for complete information about this product and your||
7177|008|Z|specific health needs.||
7177|009|B|||
7177|010|T|LEVOCARNITINE - INJECTION||
7177|011|F|(lee-voh-KAR-nih-teen)||
7177|012|B|||
7177|013|C|COMMON BRAND NAME(S): Carnitor||
7177|014|B|||
7177|015|U|USES:  This medication is used to prevent and treat low blood||
7177|016|U|levels of carnitine. Carnitine is a substance made in the body||
7177|017|U|from meat and dairy products. It helps the body use certain||
7177|018|U|chemicals (long-chain fatty acids) for energy and to keep you in||
7177|019|U|good health. Low blood levels of carnitine may occur in people||
7177|020|U|whose bodies cannot properly use carnitine from their diets,||
7177|021|U|people on dialysis due to serious kidney disease, and people||
7177|022|U|being treated with certain drugs (such as valproic acid,||
7177|023|U|zidovudine). Carnitine levels that are too low can cause liver,||
7177|024|U|heart, and muscle problems.||
7177|025|U|   The injectable form of this drug is recommended if you have||
7177|026|U|serious kidney disease (such as ESRD/dialysis) because high doses||
7177|027|U|of the form taken by mouth may increase the risk of serious side||
7177|028|U|effects. Consult your doctor or pharmacist for details.||
7177|029|B|||
7177|030|H|HOW TO USE:  This medication is given into a vein by slow||
7177|031|H|injection or through an IV, as directed by your doctor. The||
7177|032|H|dosage is based on your weight, medical condition, and response||
7177|033|H|to treatment.||
7177|034|H|   If you are giving this medication to yourself at home, learn||
7177|035|H|all preparation and usage instructions from your health care||
7177|036|H|professional. Before using, check this product for particles or||
7177|037|H|discoloration. If either is present, do not use the liquid. Learn||
7177|038|H|how to store and discard medical supplies safely.||
7177|039|H|   Tell your doctor if your condition lasts or gets worse.||
7177|040|B|||
7177|041|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, diarrhea,||
7177|042|S|headache, muscle pain/weakness, swelling of hands/lower||
7177|043|S|legs/feet, tingling skin, or body odor ("fishy" smell) may occur.||
7177|044|S|If any of these effects last or get worse, tell your doctor or||
7177|045|S|pharmacist promptly.||
7177|046|S|   Remember that this medication has been prescribed because your||
7177|047|S|doctor has judged that the benefit to you is greater than the||
7177|048|S|risk of side effects. Many people using this medication do not||
7177|049|S|have serious side effects.||
7177|050|S|   Get medical help right away if you have any very serious side||
7177|051|S|effects, including: seizure.||
7177|052|S|   A very serious allergic reaction to this drug is rare.||
7177|053|S|However, get medical help right away if you notice any symptoms||
7177|054|S|of a serious allergic reaction, including: rash, itching/swelling||
7177|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7177|056|S|breathing.||
7177|057|S|   This is not a complete list of possible side effects. If you||
7177|058|S|notice other effects not listed above, contact your doctor or||
7177|059|S|pharmacist.||
7177|060|S|   In the US -||
7177|061|S|   Call your doctor for medical advice about side effects. You||
7177|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7177|063|S|www.fda.gov/medwatch.||
7177|064|S|   In Canada - Call your doctor for medical advice about side||
7177|065|S|effects. You may report side effects to Health Canada at||
7177|066|S|1-866-234-2345.||
7177|067|B|||
7177|068|P|PRECAUTIONS:  Before using levocarnitine, tell your doctor or||
7177|069|P|pharmacist if you are allergic to it; or if you have any other||
7177|070|P|allergies. This product may contain inactive ingredients, which||
7177|071|P|can cause allergic reactions or other problems. Talk to your||
7177|072|P|pharmacist for more details.||
7177|073|P|   Before using this medication, tell your doctor or pharmacist||
7177|074|P|your medical history, especially of: kidney disease, seizures.||
7177|075|P|   During pregnancy, this medication should be used only when||
7177|076|P|clearly needed. Discuss the risks and benefits with your doctor.||
7177|077|P|   It is unknown if this drug passes into breast milk. Consult||
7177|078|P|your doctor before breastfeeding.||
7177|079|B|||
7177|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7177|081|I|medications work or increase your risk for serious side effects.||
7177|082|I|This document does not contain all possible drug interactions.||
7177|083|I|Keep a list of all the products you use (including||
7177|084|I|prescription/nonprescription drugs and herbal products) and share||
7177|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
7177|086|I|the dosage of any medicines without your doctor's approval.||
7177|087|B|||
7177|088|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7177|089|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7177|090|O|poison control center right away. US residents can call||
7177|091|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7177|092|B|||
7177|093|N|NOTES:  Do not share this medication with others.||
7177|094|N|   Lab and/or medical tests (such as serum carnitine levels)||
7177|095|N|should be done while you are using this medication. Keep all||
7177|096|N|medical and lab appointments. Consult your doctor for more||
7177|097|N|details.||
7177|098|B|||
7177|099|D|MISSED DOSE:  It is important to get each dose of this medication||
7177|100|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7177|101|D|right away for a new dosing schedule. Do not double the dose to||
7177|102|D|catch up.||
7177|103|B|||
7177|104|R|STORAGE:  Store the unmixed vials at room temperature. Do not||
7177|105|R|freeze. After mixing and dilution, the drug may be stored at room||
7177|106|R|temperature for up to 24 hours. Discard any unused portion of an||
7177|107|R|opened vial. Keep all medications away from children and pets.||
7177|108|R|   Do not flush medications down the toilet or pour them into a||
7177|109|R|drain unless instructed to do so. Properly discard this product||
7177|110|R|when it is expired or no longer needed. Consult your pharmacist||
7177|111|R|or local waste disposal company.||
7177|112|B|||
7177|113|A|Information last revised January 2025.||
7177|114|A|Copyright(c) 2025 First Databank, Inc.||
7177|115|B|||
7179|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7179|002|Z|does NOT have all possible information about this product. This||
7179|003|Z|information does not assure that this product is safe, effective,||
7179|004|Z|or appropriate for you. This information is not individual||
7179|005|Z|medical advice and does not substitute for the advice of your||
7179|006|Z|health care professional. Always ask your health care||
7179|007|Z|professional for complete information about this product and your||
7179|008|Z|specific health needs.||
7179|009|B|||
7179|010|T|CLIOQUINOL/HYDROCORTISONE - TOPICAL||
7179|011|F|(kleye-oh-KWIN-ohl/hye-dro-KOR-tih-sown)||
7179|012|B|||
7179|013|C|COMMON BRAND NAME(S): Viocort||
7179|014|B|||
7179|015|U|USES:  This combination medication is used to treat a variety of||
7179|016|U|skin conditions (including eczema, fungal skin infections such as||
7179|017|U|ringworm/athlete's foot/jock itch). This product contains 2||
7179|018|U|medications. Clioquinol (also known as iodochlorhydroxyquin) is||
7179|019|U|an antibiotic that works by preventing the growth of||
7179|020|U|fungus/bacteria. Hydrocortisone is a mild corticosteroid that||
7179|021|U|works by reducing the swelling, redness, and itching that occurs||
7179|022|U|in the affected skin.||
7179|023|U|   This medication should not be used by children younger than 2||
7179|024|U|years.||
7179|025|B|||
7179|026|H|HOW TO USE:  Use this medication on the skin only. Clean and||
7179|027|H|thoroughly dry the area to be treated. Apply a thin layer of the||
7179|028|H|medication to the affected area and gently rub in as directed by||
7179|029|H|your doctor, usually 3 to 4 times daily. Wash your hands after||
7179|030|H|using unless you are using this medication to treat the hands. Do||
7179|031|H|not wrap, cover, or bandage the area unless directed to do so by||
7179|032|H|your doctor.||
7179|033|H|   Do not apply the medication in the eyes, nose, mouth, or||
7179|034|H|inside the vagina. If you do get the medication in those areas,||
7179|035|H|flush with plenty of water.||
7179|036|H|   Do not apply more often or use longer than prescribed. Doing||
7179|037|H|so may increase the risk of side effects.||
7179|038|H|   Use this medication regularly to get the most benefit from it.||
7179|039|H|To help you remember, use it at the same times each day.||
7179|040|H|   Continue to use this medication until the full prescribed||
7179|041|H|amount is finished, even if symptoms disappear after a few days.||
7179|042|H|Stopping the medication too early may result in a return of the||
7179|043|H|infection.||
7179|044|H|   Tell your doctor if your condition lasts or gets worse.||
7179|045|B|||
7179|046|S|SIDE EFFECTS:  Dry skin may occur. If this effect lasts or gets||
7179|047|S|worse, tell your doctor or pharmacist promptly.||
7179|048|S|   Remember that this medication has been prescribed because your||
7179|049|S|doctor has judged that the benefit to you is greater than the||
7179|050|S|risk of side effects. Many people using this medication do not||
7179|051|S|have serious side effects.||
7179|052|S|   Tell your doctor right away if you have any serious side||
7179|053|S|effects, including: skin irritation/burning, extreme hair growth,||
7179|054|S|skin thinning/discoloration, acne, stretch marks, small red bumps||
7179|055|S|on the skin (folliculitis).||
7179|056|S|   Use of this medication for prolonged or repeated periods may||
7179|057|S|result in a new infection. Contact your doctor if you notice any||
7179|058|S|new symptoms on the skin.||
7179|059|S|   A very serious allergic reaction to this drug is rare.||
7179|060|S|However, get medical help right away if you notice any symptoms||
7179|061|S|of a serious allergic reaction, including: rash, itching/swelling||
7179|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7179|063|S|breathing.||
7179|064|S|   This is not a complete list of possible side effects. If you||
7179|065|S|notice other effects not listed above, contact your doctor or||
7179|066|S|pharmacist.||
7179|067|S|   In the US -||
7179|068|S|   Call your doctor for medical advice about side effects. You||
7179|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7179|070|S|www.fda.gov/medwatch.||
7179|071|S|   In Canada - Call your doctor for medical advice about side||
7179|072|S|effects. You may report side effects to Health Canada at||
7179|073|S|1-866-234-2345.||
7179|074|B|||
7179|075|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
7179|076|P|pharmacist if you are allergic to clioquinol or hydrocortisone;||
7179|077|P|or to other 8-hydroxyquinolines (such as iodoquinol); or to other||
7179|078|P|corticosteroids (such as triamcinolone); or to iodine; or if you||
7179|079|P|have any other allergies. This product may contain inactive||
7179|080|P|ingredients, which can cause allergic reactions or other||
7179|081|P|problems. Talk to your pharmacist for more details.||
7179|082|P|   Before using this medication, tell your doctor or pharmacist||
7179|083|P|your medical history, especially of: tuberculosis of the skin,||
7179|084|P|viral skin/eye infections (such as herpes, chickenpox), immune||
7179|085|P|system problems, poor blood circulation.||
7179|086|P|   This medication may stain clothes, skin, nails, or hair. Use||
7179|087|P|cautiously to avoid contact with clothes, nails, or hair.||
7179|088|P|   Children may be more sensitive to the effects of too much||
7179|089|P|corticosteroid medication. Consult your doctor for more details.||
7179|090|P|   During pregnancy, this medication should be used only when||
7179|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
7179|092|P|   It is unknown if this medication passes into breast milk.||
7179|093|P|Consult your doctor before breastfeeding.||
7179|094|B|||
7179|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7179|096|I|medications work or increase your risk for serious side effects.||
7179|097|I|This document does not contain all possible drug interactions.||
7179|098|I|Keep a list of all the products you use (including||
7179|099|I|prescription/nonprescription drugs and herbal products) and share||
7179|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
7179|101|I|the dosage of any medicines without your doctor's approval.||
7179|102|I|   This medication may interfere with certain lab tests (such as||
7179|103|I|certain thyroid function tests), possibly causing false test||
7179|104|I|results. Make sure lab personnel and all your doctors know you||
7179|105|I|use this drug.||
7179|106|B|||
7179|107|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7179|108|O|has overdosed and has serious symptoms such as passing out or||
7179|109|O|trouble breathing, call 911. Otherwise, call a poison control||
7179|110|O|center right away. US residents can call 1-800-222-1222. Canada||
7179|111|O|residents can call 1-844-764-7669.||
7179|112|B|||
7179|113|N|NOTES:  Do not share this medication with others.||
7179|114|N|   This medication has been prescribed for your current condition||
7179|115|N|only. Do not use it later for another skin condition unless told||
7179|116|N|to do so by your doctor. A different medication may be necessary||
7179|117|N|in that case.||
7179|118|B|||
7179|119|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7179|120|D|If it is near the time of the next dose, skip the missed dose.||
7179|121|D|Use your next dose at the regular time. Do not double the dose to||
7179|122|D|catch up.||
7179|123|B|||
7179|124|R|STORAGE:  Store at room temperature. Keep all medications away||
7179|125|R|from children and pets.||
7179|126|R|   Do not flush medications down the toilet or pour them into a||
7179|127|R|drain unless instructed to do so. Properly discard this product||
7179|128|R|when it is expired or no longer needed. Consult your pharmacist||
7179|129|R|or local waste disposal company.||
7179|130|B|||
7179|131|A|Information last revised May 2024.||
7179|132|A|Copyright(c) 2025 First Databank, Inc.||
7179|133|B|||
7181|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7181|002|Z|does NOT have all possible information about this product. This||
7181|003|Z|information does not assure that this product is safe, effective,||
7181|004|Z|or appropriate for you. This information is not individual||
7181|005|Z|medical advice and does not substitute for the advice of your||
7181|006|Z|health care professional. Always ask your health care||
7181|007|Z|professional for complete information about this product and your||
7181|008|Z|specific health needs.||
7181|009|B|||
7181|010|T|ERYTHROMYCIN PADS - TOPICAL||
7181|011|F|(eh-rith-row-MY-sin)||
7181|012|B|||
7181|013|C|COMMON BRAND NAME(S): Erycette||
7181|014|B|||
7181|015|U|USES:  This medication is used to treat acne. It helps to reduce||
7181|016|U|the number of pimples. Erythromycin is an antibiotic||
7181|017|U|(macrolide-type). It works by stopping the growth of bacteria.||
7181|018|U|This product contains a large amount of alcohol, which dries||
7181|019|U|extra oils from the skin.||
7181|020|B|||
7181|021|H|HOW TO USE:  This medication is for use on the skin only. Clean||
7181|022|H|and dry the affected area as directed. Then wipe the area gently||
7181|023|H|with a medicated pad as directed by your doctor, usually twice a||
7181|024|H|day. Depending on the size of the area to be treated, more than||
7181|025|H|one pad may be needed. Use each pad only once and then discard.||
7181|026|H|Wash your hands after use.||
7181|027|H|   Do not use this more often or for a longer period than||
7181|028|H|directed. Your condition will not clear faster, but the risk of||
7181|029|H|side effects may be increased.||
7181|030|H|   Use this medication regularly in order to get the most benefit||
7181|031|H|from it. Remember to use it at the same times each day.||
7181|032|H|   Avoid getting this medication in your eyes or inside the nose||
7181|033|H|or mouth. If this occurs, rinse thoroughly with water.||
7181|034|H|   Tell your doctor if your condition does not get better or if||
7181|035|H|it gets worse. It may take up to 3 months of regular use before||
7181|036|H|the full benefits of this medication take effect.||
7181|037|B|||
7181|038|S|SIDE EFFECTS:  Burning, redness, itching, or dry/peeling/oily||
7181|039|S|skin may occur, especially in the first few days as your body||
7181|040|S|adjusts to the medication. Eye irritation may also occur. If any||
7181|041|S|of these effects last or get worse, tell your doctor or||
7181|042|S|pharmacist promptly.||
7181|043|S|   Remember that this medication has been prescribed because your||
7181|044|S|doctor has judged that the benefit to you is greater than the||
7181|045|S|risk of side effects. Many people using this medication do not||
7181|046|S|have serious side effects.||
7181|047|S|   Rarely, use of this medication may result in other types of||
7181|048|S|skin infections (fungal or other bacterial infections). Contact||
7181|049|S|your doctor if you notice any unusual skin irritation or other||
7181|050|S|symptoms.||
7181|051|S|   A very serious allergic reaction to this drug is rare.||
7181|052|S|However, get medical help right away if you notice any symptoms||
7181|053|S|of a serious allergic reaction, including: rash, itching/swelling||
7181|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7181|055|S|breathing.||
7181|056|S|   This is not a complete list of possible side effects. If you||
7181|057|S|notice other effects not listed above, contact your doctor or||
7181|058|S|pharmacist.||
7181|059|S|   In the US -||
7181|060|S|   Call your doctor for medical advice about side effects. You||
7181|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7181|062|S|www.fda.gov/medwatch.||
7181|063|S|   In Canada - Call your doctor for medical advice about side||
7181|064|S|effects. You may report side effects to Health Canada at||
7181|065|S|1-866-234-2345.||
7181|066|B|||
7181|067|P|PRECAUTIONS:  Before using erythromycin, tell your doctor or||
7181|068|P|pharmacist if you are allergic to it; or to other antibiotics||
7181|069|P|(such as azithromycin, clarithromycin); or if you have any other||
7181|070|P|allergies. This product may contain inactive ingredients, which||
7181|071|P|can cause allergic reactions or other problems. Talk to your||
7181|072|P|pharmacist for more details.||
7181|073|P|   Before using this medication, tell your doctor or pharmacist||
7181|074|P|your medical history.||
7181|075|P|   During pregnancy, this medication should be used only when||
7181|076|P|clearly needed. Discuss the risks and benefits with your doctor.||
7181|077|P|   It is unknown if this medication passes into breast milk.||
7181|078|P|Consult your doctor before breastfeeding.||
7181|079|B|||
7181|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7181|081|I|medications work or increase your risk for serious side effects.||
7181|082|I|This document does not contain all possible drug interactions.||
7181|083|I|Keep a list of all the products you use (including||
7181|084|I|prescription/nonprescription drugs and herbal products) and share||
7181|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
7181|086|I|the dosage of any medicines without your doctor's approval.||
7181|087|I|   A product that may interact with this drug is: disulfiram.||
7181|088|B|||
7181|089|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7181|090|O|has overdosed and has serious symptoms such as passing out or||
7181|091|O|trouble breathing, call 911. Otherwise, call a poison control||
7181|092|O|center right away. US residents can call 1-800-222-1222. Canada||
7181|093|O|residents can call 1-844-764-7669.||
7181|094|B|||
7181|095|N|NOTES:  Do not share this medication with others.||
7181|096|N|   For the best results, this medication is often used as part of||
7181|097|N|a total skin care program. Follow your doctor's recommendations.||
7181|098|B|||
7181|099|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7181|100|D|If it is near the time of the next dose, skip the missed dose.||
7181|101|D|Use your next dose at the regular time. Do not double the dose to||
7181|102|D|catch up.||
7181|103|B|||
7181|104|R|STORAGE:  Store at room temperature. This medication is||
7181|105|R|flammable. Keep it away from heat and open flame. Keep all||
7181|106|R|medications away from children and pets.||
7181|107|R|   Do not flush medications down the toilet or pour them into a||
7181|108|R|drain unless instructed to do so. Properly discard this product||
7181|109|R|when it is expired or no longer needed. Consult your pharmacist||
7181|110|R|or local waste disposal company.||
7181|111|B|||
7181|112|A|Information last revised July 2025.||
7181|113|A|Copyright(c) 2025 First Databank, Inc.||
7181|114|B|||
7183|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7183|002|Z|does NOT have all possible information about this product. This||
7183|003|Z|information does not assure that this product is safe, effective,||
7183|004|Z|or appropriate for you. This information is not individual||
7183|005|Z|medical advice and does not substitute for the advice of your||
7183|006|Z|health care professional. Always ask your health care||
7183|007|Z|professional for complete information about this product and your||
7183|008|Z|specific health needs.||
7183|009|B|||
7183|010|T|LEFLUNOMIDE - ORAL||
7183|011|F|(leh-FLEW-no-mide)||
7183|012|B|||
7183|013|C|COMMON BRAND NAME(S): Arava||
7183|014|B|||
7183|015|W|WARNING:  Leflunomide must not be used during pregnancy because||
7183|016|W|it may cause serious harm (possibly death) to an unborn baby.||
7183|017|W|Women of childbearing age must have a negative pregnancy test||
7183|018|W|before starting this medication. They must also use reliable||
7183|019|W|forms of birth control during treatment and after stopping it||
7183|020|W|until they have finished taking another drug that helps||
7183|021|W|leflunomide leave the body and confirmed through 2 blood tests||
7183|022|W|that the leflunomide levels are very low (see How to Use||
7183|023|W|section). If you become pregnant or think you may be pregnant,||
7183|024|W|tell your doctor right away (see also Precautions section).||
7183|025|W|   This drug may rarely cause serious (possibly fatal) liver||
7183|026|W|disease. Most cases occur within 6 months of taking this drug. If||
7183|027|W|you already have liver disease (such as hepatitis B or C),||
7183|028|W|leflunomide should not be used. Liver function (blood) tests must||
7183|029|W|be performed periodically while taking leflunomide. Tell your||
7183|030|W|doctor right away if you notice nausea/vomiting that doesn't||
7183|031|W|stop, dark urine, light-colored stools, stomach/abdominal pain,||
7183|032|W|yellowing eyes/skin. See Drug Interactions section.||
7183|033|B|||
7183|034|U|USES:  This medication is used to treat rheumatoid arthritis, a||
7183|035|U|condition in which the body's defense system (immune system)||
7183|036|U|fails to recognize the body as itself and attacks the healthy||
7183|037|U|tissues around the joints. Leflunomide helps to reduce the joint||
7183|038|U|damage/pain/swelling and helps you to move better. It works by||
7183|039|U|weakening your immune system and decreasing swelling||
7183|040|U|(inflammation).||
7183|041|B|||
7183|042|V|OTHER USES:  This section contains uses of this drug that are not||
7183|043|V|listed in the approved professional labeling for the drug but||
7183|044|V|that may be prescribed by your health care professional. Use this||
7183|045|V|drug for a condition that is listed in this section only if it||
7183|046|V|has been so prescribed by your health care professional.||
7183|047|V|   This drug may also be used for psoriatic arthritis. It may||
7183|048|V|also be used to reduce the risk of rejection of organ transplant.||
7183|049|B|||
7183|050|H|HOW TO USE:  Take this medication by mouth with or without food||
7183|051|H|as directed by your doctor, usually once daily. Take this||
7183|052|H|medication exactly as prescribed. You may be instructed to take a||
7183|053|H|higher dose for the first 3 days of treatment.||
7183|054|H|   The dosage is based on your medical condition and response to||
7183|055|H|treatment.||
7183|056|H|   Take this medication regularly in order to get the most||
7183|057|H|benefit from it. To help you remember, take it at the same time||
7183|058|H|each day.||
7183|059|H|   After treatment is stopped, a different drug (cholestyramine)||
7183|060|H|may be given as directed to help remove leflunomide from your||
7183|061|H|body. This procedure is used if you need a rapid removal of the||
7183|062|H|drug from your system (for example, if you are a female/male||
7183|063|H|planning to have children, or suffering from severe side||
7183|064|H|effects). Without the procedure, the drug may stay in your body||
7183|065|H|for up to 2 years. Consult your doctor or pharmacist for more||
7183|066|H|details.||
7183|067|H|   Tell your doctor if your symptoms last or get worse.||
7183|068|B|||
7183|069|S|SIDE EFFECTS:  Diarrhea, nausea, and dizziness may occur. If any||
7183|070|S|of these effects last or get worse, tell your doctor or||
7183|071|S|pharmacist promptly.||
7183|072|S|   Remember that this medication has been prescribed because your||
7183|073|S|doctor has judged that the benefit to you is greater than the||
7183|074|S|risk of side effects. Many people using this medication do not||
7183|075|S|have serious side effects.||
7183|076|S|   Tell your doctor right away if you have any serious side||
7183|077|S|effects, including: cough, numbness/tingling of hands/feet, hair||
7183|078|S|loss, chest pain, fast/pounding heartbeat, increased||
7183|079|S|thirst/urination, muscle cramp/pain, mental/mood changes, vision||
7183|080|S|changes, easy bruising/bleeding, unusual growths/lumps,||
7183|081|S|unexplained weight loss, unusual tiredness.||
7183|082|S|   This medication may raise your blood pressure. Check your||
7183|083|S|blood pressure regularly and tell your doctor if the results are||
7183|084|S|high.||
7183|085|S|   This medication may lower your ability to fight infections.||
7183|086|S|This may make you more likely to get a serious (rarely fatal)||
7183|087|S|infection or make any infection you have worse. Get medical help||
7183|088|S|right away if you have any signs of infection (such as sore||
7183|089|S|throat that doesn't go away, fever, swollen lymph nodes, chills).||
7183|090|S|   Get medical help right away if you have any very serious side||
7183|091|S|effects, including: skin sores.||
7183|092|S|   A very serious allergic reaction to this drug is rare.||
7183|093|S|However, get medical help right away if you notice any symptoms||
7183|094|S|of a serious allergic reaction, including: rash, itching/swelling||
7183|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7183|096|S|breathing.||
7183|097|S|   Leflunomide can commonly cause a mild rash that is usually not||
7183|098|S|serious. However, you may not be able to tell it apart from a||
7183|099|S|rare rash that could be a sign of a severe allergic reaction. Get||
7183|100|S|medical help right away if you develop any rash.||
7183|101|S|   This is not a complete list of possible side effects. If you||
7183|102|S|notice other effects not listed above, contact your doctor or||
7183|103|S|pharmacist.||
7183|104|S|   In the US -||
7183|105|S|   Call your doctor for medical advice about side effects. You||
7183|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7183|107|S|www.fda.gov/medwatch.||
7183|108|S|   In Canada - Call your doctor for medical advice about side||
7183|109|S|effects. You may report side effects to Health Canada at||
7183|110|S|1-866-234-2345.||
7183|111|B|||
7183|112|P|PRECAUTIONS:  Before taking leflunomide, tell your doctor or||
7183|113|P|pharmacist if you are allergic to it; or to teriflunomide; or if||
7183|114|P|you have any other allergies. This product may contain inactive||
7183|115|P|ingredients, which can cause allergic reactions or other||
7183|116|P|problems. Talk to your pharmacist for more details.||
7183|117|P|   Before using this medication, tell your doctor or pharmacist||
7183|118|P|your medical history, especially of: immune system disorder (such||
7183|119|P|as HIV infection), current/recent infection (such as||
7183|120|P|tuberculosis), cancer, bone marrow/blood disorder, kidney||
7183|121|P|disease, liver disease (such as hepatitis B or C), alcohol abuse,||
7183|122|P|heart disease (such as heart failure), high blood pressure, lung||
7183|123|P|disease.||
7183|124|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7183|125|P|can make you more dizzy. Do not drive, use machinery, or do||
7183|126|P|anything that needs alertness until you can do it safely. Avoid||
7183|127|P|alcoholic beverages. Talk to your doctor if you are using||
7183|128|P|marijuana (cannabis). Alcohol may also cause liver disease.||
7183|129|P|   Do not have immunizations/vaccinations without the consent of||
7183|130|P|your doctor, and avoid contact with people who have recently||
7183|131|P|received oral polio vaccine or flu vaccine inhaled through the||
7183|132|P|nose.||
7183|133|P|   Leflunomide can make you more likely to get infections or may||
7183|134|P|make current infections worse. Stay away from anyone who has an||
7183|135|P|infection that may easily spread (such as chickenpox, COVID-19,||
7183|136|P|measles, flu). Talk to your doctor if you have been exposed to an||
7183|137|P|infection or for more details.||
7183|138|P|   Before having surgery, tell your doctor or dentist about all||
7183|139|P|the products you use (including prescription drugs,||
7183|140|P|nonprescription drugs, and herbal products).||
7183|141|P|   This medication must not be used during pregnancy. It may harm||
7183|142|P|an unborn baby. Women of childbearing age must have a negative||
7183|143|P|pregnancy test before starting this medication. Women using this||
7183|144|P|medication should ask about reliable forms of birth control||
7183|145|P|during treatment and for some time after the last dose. Men using||
7183|146|P|this medication and their female partners should ask about||
7183|147|P|reliable forms of birth control during treatment. If you or your||
7183|148|P|partner becomes pregnant or may be pregnant, tell your doctor||
7183|149|P|right away. (See also Warning section.)||
7183|150|P|   It is not known whether this medication affects the sperm. To||
7183|151|P|minimize any possible risk, the manufacturer recommends that men||
7183|152|P|wishing to father a child should stop the medication and use||
7183|153|P|another drug (cholestyramine) as directed to help this drug leave||
7183|154|P|the body before attempting to father a child. (See How to Use||
7183|155|P|section.) Consult your doctor for more details.||
7183|156|P|   This drug may pass into breast milk and could have undesirable||
7183|157|P|effects on a nursing infant. Breastfeeding is not recommended||
7183|158|P|while using this drug. Consult your doctor before breastfeeding.||
7183|159|B|||
7183|160|I|DRUG INTERACTIONS:  See also How to Use Section.||
7183|161|I|   Drug interactions may change how your medications work or||
7183|162|I|increase your risk for serious side effects. This document does||
7183|163|I|not contain all possible drug interactions. Keep a list of all||
7183|164|I|the products you use (including prescription/nonprescription||
7183|165|I|drugs and herbal products) and share it with your doctor and||
7183|166|I|pharmacist. Do not start, stop, or change the dosage of any||
7183|167|I|medicines without your doctor's approval.||
7183|168|I|   Some products that may interact with this drug include:||
7183|169|I|cholestyramine, warfarin, drugs affecting the liver (such as||
7183|170|I|methotrexate), other drugs that weaken the immune system (such as||
7183|171|I|cyclosporine, tacrolimus).||
7183|172|I|   This medication can slow down the removal of other medications||
7183|173|I|from your body, which may affect how they work. Examples of||
7183|174|I|affected drugs include ketorolac, tovorafenib, among others.||
7183|175|I|   This medication can speed up the removal of other medications||
7183|176|I|from your body, which may affect how they work. Examples of||
7183|177|I|affected drugs include vorasidenib, among others.||
7183|178|I|   Because teriflunomide (used to treat multiple sclerosis) is||
7183|179|I|very similar to this medication, do not take it while you are||
7183|180|I|taking leflunomide.||
7183|181|B|||
7183|182|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7183|183|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7183|184|O|poison control center right away. US residents can call||
7183|185|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7183|186|B|||
7183|187|N|NOTES:  Do not share this medication with others.||
7183|188|N|   A skin test to check for tuberculosis should be done before||
7183|189|N|you start this medication. Lab and/or medical tests (such as||
7183|190|N|liver function, blood counts, blood pressure) should be done||
7183|191|N|while you are taking this medication. Keep all medical and lab||
7183|192|N|appointments. Consult your doctor for more details.||
7183|193|B|||
7183|194|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7183|195|D|remember. If it is near the time of the next dose, skip the||
7183|196|D|missed dose. Take your next dose at the regular time. Do not||
7183|197|D|double the dose to catch up.||
7183|198|B|||
7183|199|R|STORAGE:  Store at room temperature away from light and moisture.||
7183|200|R|Do not store in the bathroom. Keep all medications away from||
7183|201|R|children and pets.||
7183|202|R|   Do not flush medications down the toilet or pour them into a||
7183|203|R|drain unless instructed to do so. Properly discard this product||
7183|204|R|when it is expired or no longer needed. Consult your pharmacist||
7183|205|R|or local waste disposal company.||
7183|206|B|||
7183|207|M|MEDICAL ALERT:  Your condition can cause complications in a||
7183|208|M|medical emergency. For information about enrolling in MedicAlert,||
7183|209|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7183|210|B|||
7183|211|A|Information last revised February 2025.||
7183|212|A|Copyright(c) 2025 First Databank, Inc.||
7183|213|B|||
7185|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7185|002|Z|does NOT have all possible information about this product. This||
7185|003|Z|information does not assure that this product is safe, effective,||
7185|004|Z|or appropriate for you. This information is not individual||
7185|005|Z|medical advice and does not substitute for the advice of your||
7185|006|Z|health care professional. Always ask your health care||
7185|007|Z|professional for complete information about this product and your||
7185|008|Z|specific health needs.||
7185|009|B|||
7185|010|T|TRIAMCINOLONE - NASAL||
7185|011|F|(TRYE-am-SIN-oh-lone)||
7185|012|B|||
7185|013|C|COMMON BRAND NAME(S): Nasacort||
7185|014|B|||
7185|015|U|USES:  Triamcinolone is used to prevent and treat seasonal and||
7185|016|U|year-round allergy symptoms (such as stuffy/runny nose, itchy||
7185|017|U|eyes/nose/throat, sneezing). Triamcinolone belongs to a class of||
7185|018|U|drugs known as corticosteroids. It works by reducing swelling||
7185|019|U|(inflammation) in the nasal passages.||
7185|020|U|   Check the ingredients on the label even if you have used the||
7185|021|U|product before. The manufacturer may have changed the||
7185|022|U|ingredients. Also, products with similar names may contain||
7185|023|U|different ingredients meant for different purposes. Taking the||
7185|024|U|wrong product could harm you.||
7185|025|B|||
7185|026|H|HOW TO USE:  If you are taking the over-the-counter product to||
7185|027|H|self-treat, read and follow all directions on the product package||
7185|028|H|before taking this medication. If you have any questions, consult||
7185|029|H|your pharmacist. If your doctor has prescribed this medication,||
7185|030|H|take it as directed.||
7185|031|H|   Read the Patient Information Leaflet if available from your||
7185|032|H|pharmacist before you start using this medication and each time||
7185|033|H|you get a refill. Follow the illustrated directions for the||
7185|034|H|proper use of this medication. If you have any questions, ask||
7185|035|H|your doctor or pharmacist.||
7185|036|H|   Use this medication in the nose as directed by your doctor or||
7185|037|H|the product package, usually once a day. Avoid spraying this||
7185|038|H|medication in your eyes or mouth. Gently blow your nose before||
7185|039|H|using this drug. Shake the spray device well before each use.||
7185|040|H|Follow the package instructions to properly prime the spray.||
7185|041|H|   Remove the protective cap before using the spray. Close one||
7185|042|H|nostril by pressing it with your finger. Tilt your head as||
7185|043|H|directed and carefully insert the nasal applicator into the other||
7185|044|H|nostril. Press down firmly on the device to deliver the||
7185|045|H|prescribed number of sprays. Do not spray directly onto the||
7185|046|H|middle wall of your nose (nasal septum). Breathe in gently||
7185|047|H|through your nose and out through your mouth. Repeat in the other||
7185|048|H|nostril. Replace the cap on the nasal inhaler. Avoid blowing your||
7185|049|H|nose for 15 minutes after using this medication.||
7185|050|H|   The dosage is based on your medical condition and response to||
7185|051|H|treatment. Younger children may need a smaller dose and help from||
7185|052|H|an adult to use this medication properly. Use this medication||
7185|053|H|regularly in order to get the most benefit from it. To help you||
7185|054|H|remember, use it at the same time(s) each day. Do not increase||
7185|055|H|your dose or use it more often than directed.||
7185|056|H|   This medication does not work right away. Some people will||
7185|057|H|feel this medication working within 1 day, but it may take up to||
7185|058|H|1 week before the full benefit of this drug takes effect. Ask||
7185|059|H|your doctor or pharmacist if you should also use other||
7185|060|H|medications (such as nose drops/spray, allergy drugs taken by||
7185|061|H|mouth) along with this drug until it takes full effect.||
7185|062|H|   Keep track of the number of sprays used from the device.||
7185|063|H|Discard the device after you have used the number of sprays||
7185|064|H|specified on the manufacturer's package. Do not pour any||
7185|065|H|remaining medication into another container. Follow the package||
7185|066|H|instructions to unblock or to clean the spray device.||
7185|067|H|   If your condition lasts or gets worse, or if you think you may||
7185|068|H|have a serious medical problem, get medical help right away.||
7185|069|B|||
7185|070|S|SIDE EFFECTS:  Nose/throat dryness or irritation, cough,||
7185|071|S|sneezing, nosebleeds, and unpleasant taste/smell may occur. If||
7185|072|S|any of these side effects last or get worse, tell your doctor or||
7185|073|S|pharmacist promptly.||
7185|074|S|   If your doctor has prescribed this medication, remember that||
7185|075|S|your doctor has judged that the benefit to you is greater than||
7185|076|S|the risk of side effects. Many people using this medication do||
7185|077|S|not have serious side effects.||
7185|078|S|   Tell your doctor right away if you have any serious side||
7185|079|S|effects, including: loss of taste or smell, pain/sores in your||
7185|080|S|nose.||
7185|081|S|   Rarely, it is possible that corticosteroids given in the nose||
7185|082|S|will be absorbed into the bloodstream. This can lead to side||
7185|083|S|effects of too much corticosteroid. These side effects are more||
7185|084|S|likely in children and people who use this medication for a long||
7185|085|S|time and in high doses. Tell your doctor right away if any of the||
7185|086|S|following side effects occur: unusual/extreme tiredness, weight||
7185|087|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
7185|088|S|vision problems.||
7185|089|S|   Corticosteroids may weaken the body's ability to fight||
7185|090|S|infections. This may make you more likely to get a serious||
7185|091|S|(rarely fatal) infection or make any infection you have worse.||
7185|092|S|This effect might also rarely occur with corticosteroids inhaled||
7185|093|S|through the nose (such as triamcinolone). The risk may be||
7185|094|S|increased if high doses are used, especially when used for a long||
7185|095|S|time. Tell your doctor right away if you have any signs of||
7185|096|S|infection (such as sore throat that doesn't go away, fever,||
7185|097|S|chills, white patches inside the nose or on the back of the||
7185|098|S|throat).||
7185|099|S|   A very serious allergic reaction to this drug is rare.||
7185|100|S|However, get medical help right away if you notice any symptoms||
7185|101|S|of a serious allergic reaction, including: rash, itching/swelling||
7185|102|S|(especially of the face/tongue/throat), severe dizziness,||
7185|103|S|wheezing/trouble breathing.||
7185|104|S|   This is not a complete list of possible side effects. If you||
7185|105|S|notice other effects not listed above, contact your doctor or||
7185|106|S|pharmacist.||
7185|107|S|   In the US -||
7185|108|S|   Call your doctor for medical advice about side effects. You||
7185|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7185|110|S|www.fda.gov/medwatch.||
7185|111|S|   In Canada - Call your doctor for medical advice about side||
7185|112|S|effects. You may report side effects to Health Canada at||
7185|113|S|1-866-234-2345.||
7185|114|B|||
7185|115|P|PRECAUTIONS:  Before using nasal triamcinolone, tell your doctor||
7185|116|P|or pharmacist if you are allergic to it; or if you have any other||
7185|117|P|allergies. This product may contain inactive ingredients, which||
7185|118|P|can cause allergic reactions or other problems. Talk to your||
7185|119|P|pharmacist for more details.||
7185|120|P|   Before using this medication, tell your doctor or pharmacist||
7185|121|P|your medical history, especially of: eye problems (such as||
7185|122|P|glaucoma, cataracts), infections (including tuberculosis), recent||
7185|123|P|nose problems (such as injury, ulcers, surgery).||
7185|124|P|   Stay away from anyone who has an infection that may easily||
7185|125|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
7185|126|P|doctor if you have been exposed to an infection or for more||
7185|127|P|details.||
7185|128|P|   Rarely, using corticosteroid medications for a long time can||
7185|129|P|make it more difficult for your body to respond to physical||
7185|130|P|stress. Before having surgery or emergency treatment, or if you||
7185|131|P|get a serious illness/injury, tell your doctor or dentist that||
7185|132|P|you are using this medication or have used this medication within||
7185|133|P|the past few months.||
7185|134|P|   Before having surgery, tell your doctor or dentist about all||
7185|135|P|the products you use (including prescription drugs,||
7185|136|P|nonprescription drugs, and herbal products).||
7185|137|P|   Though it is unlikely, this medication may temporarily slow||
7185|138|P|down a child's growth if used for a long time. See the doctor||
7185|139|P|regularly so your child's height can be checked.||
7185|140|P|   During pregnancy, this medication should be used only when||
7185|141|P|clearly needed. Rarely, infants born to mothers who have been||
7185|142|P|using corticosteroids (including triamcinolone) for a long time||
7185|143|P|may have low levels of corticosteroid hormone. Tell your doctor||
7185|144|P|right away if you notice symptoms such as nausea/vomiting that||
7185|145|P|doesn't stop, severe diarrhea, or weakness in your newborn.||
7185|146|P|Discuss the risks and benefits with your doctor.||
7185|147|P|   It is unknown if this drug passes into breast milk. However,||
7185|148|P|similar drugs pass into breast milk. Consult your doctor before||
7185|149|P|breastfeeding.||
7185|150|B|||
7185|151|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7185|152|I|medications work or increase your risk for serious side effects.||
7185|153|I|This document does not contain all possible drug interactions.||
7185|154|I|Keep a list of all the products you use (including||
7185|155|I|prescription/nonprescription drugs and herbal products) and share||
7185|156|I|it with your doctor and pharmacist. Do not start, stop, or change||
7185|157|I|the dosage of any medicines without your doctor's approval.||
7185|158|B|||
7185|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7185|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7185|161|O|poison control center right away. US residents can call||
7185|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7185|163|B|||
7185|164|N|NOTES:  Do not share this medication with others.||
7185|165|N|   If you use this medication for a long time, lab and/or medical||
7185|166|N|tests (such as nose exams, height measurement in children) may be||
7185|167|N|done while you are using this medication. Keep all medical and||
7185|168|N|lab appointments. Consult your doctor for more details.||
7185|169|N|   Avoid substances (such as pollen, pet dander, dust mites,||
7185|170|N|mold, and smoke) that can worsen allergy symptoms.||
7185|171|B|||
7185|172|D|MISSED DOSE:  If you are using this product on a regular schedule||
7185|173|D|and miss a dose, use it as soon as you remember. If it is near||
7185|174|D|the time of the next dose, skip the missed dose. Use your next||
7185|175|D|dose at the regular time. Do not double the dose to catch up.||
7185|176|B|||
7185|177|R|STORAGE:  Store at room temperature. Different brands of this||
7185|178|R|medication have different storage needs. Check the product||
7185|179|R|package for instructions on how to store your brand, or ask your||
7185|180|R|pharmacist. Keep all medications away from children and pets.||
7185|181|R|   Do not flush medications down the toilet or pour them into a||
7185|182|R|drain unless instructed to do so. Properly discard this product||
7185|183|R|when it is expired or no longer needed. Consult your pharmacist||
7185|184|R|or local waste disposal company.||
7185|185|B|||
7185|186|A|Information last revised May 2025.||
7185|187|A|Copyright(c) 2025 First Databank, Inc.||
7185|188|B|||
7186|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7186|002|Z|does NOT have all possible information about this product. This||
7186|003|Z|information does not assure that this product is safe, effective,||
7186|004|Z|or appropriate for you. This information is not individual||
7186|005|Z|medical advice and does not substitute for the advice of your||
7186|006|Z|health care professional. Always ask your health care||
7186|007|Z|professional for complete information about this product and your||
7186|008|Z|specific health needs.||
7186|009|B|||
7186|010|T|KETOPROFEN SUSTAINED-ACTION CAPSULE - ORAL||
7186|011|F|(KEE-toe-PROE-fen)||
7186|012|B|||
7186|013|C|COMMON BRAND NAME(S): Oruvail||
7186|014|B|||
7186|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
7186|016|W|ketoprofen) may rarely increase the risk of a heart attack or||
7186|017|W|stroke. This effect can happen at any time while taking this drug||
7186|018|W|but is more likely if you take it for a long time. The risk may||
7186|019|W|be greater in older adults or if you have heart disease or||
7186|020|W|increased risk for heart disease (for example, due to smoking,||
7186|021|W|family history of heart disease, or conditions such as high blood||
7186|022|W|pressure or diabetes). Do not take this drug right before or||
7186|023|W|after heart bypass surgery (CABG).||
7186|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
7186|025|W|bleeding from the stomach or intestines. This effect can occur||
7186|026|W|without warning symptoms at any time while taking this drug.||
7186|027|W|Older adults may be at higher risk for this effect.||
7186|028|W|   Stop taking ketoprofen and get medical help right away if you||
7186|029|W|notice any of these rare but serious side effects:||
7186|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
7186|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
7186|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
7186|033|W|side of the body, trouble speaking, sudden vision changes.||
7186|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
7186|035|W|of taking this drug.||
7186|036|B|||
7186|037|U|USES:  See also Warning section.||
7186|038|U|   The sustained-action capsule form of ketoprofen is used to||
7186|039|U|reduce pain, swelling, and joint stiffness from arthritis.||
7186|040|U|Reducing symptoms of arthritis may improve your ability to||
7186|041|U|move/exercise, work, and perform tasks normally.||
7186|042|U|   Ketoprofen is known as a nonsteroidal anti-inflammatory drug||
7186|043|U|(NSAID). It works by blocking your body's production of certain||
7186|044|U|natural substances that cause inflammation. This effect helps to||
7186|045|U|decrease swelling, pain, or fever.||
7186|046|U|   Ask your doctor about non-drug treatments and/or using other||
7186|047|U|medications to treat your chronic pain.||
7186|048|B|||
7186|049|H|HOW TO USE:  Read the Medication Guide provided by your||
7186|050|H|pharmacist before you start taking ketoprofen and each time you||
7186|051|H|get a refill. If you have any questions, ask your doctor or||
7186|052|H|pharmacist.||
7186|053|H|   Take this medication by mouth as directed by your doctor,||
7186|054|H|usually once daily. Take this medication with a full glass of||
7186|055|H|water (8 ounces/240 milliliters) unless your doctor directs you||
7186|056|H|otherwise. Do not lie down for at least 10 minutes after taking||
7186|057|H|this medication. If stomach upset occurs while taking this||
7186|058|H|medication, it may be taken with food, milk, or an antacid.||
7186|059|H|   Swallow this medication whole. Do not crush or chew the||
7186|060|H|capsules. Doing so can release all of the drug at once,||
7186|061|H|increasing the risk of side effects.||
7186|062|H|   The dosage is based on your medical condition and response to||
7186|063|H|treatment. To reduce your risk of stomach bleeding and other side||
7186|064|H|effects, take this medication at the lowest effective dose for||
7186|065|H|the shortest possible time. Do not increase your dose or use this||
7186|066|H|drug more often or for longer than prescribed. Discuss the risks||
7186|067|H|and benefits with your doctor or pharmacist.||
7186|068|H|   It may take up to 2 weeks of taking this drug regularly until||
7186|069|H|you get the full benefit.||
7186|070|H|   Tell your doctor if your condition gets worse.||
7186|071|B|||
7186|072|S|SIDE EFFECTS:  See also Warning section.||
7186|073|S|   Upset stomach, nausea, constipation, diarrhea, gas, dizziness,||
7186|074|S|drowsiness, blurred vision, or headache may occur. If any of||
7186|075|S|these effects last or get worse, tell your doctor or pharmacist||
7186|076|S|promptly.||
7186|077|S|   Remember that this medication has been prescribed because your||
7186|078|S|doctor has judged that the benefit to you is greater than the||
7186|079|S|risk of side effects. Many people using this medication do not||
7186|080|S|have serious side effects.||
7186|081|S|   This medication may raise your blood pressure. Check your||
7186|082|S|blood pressure regularly and tell your doctor if the results are||
7186|083|S|high.||
7186|084|S|   Tell your doctor right away if you have any serious side||
7186|085|S|effects, including: hearing changes (such as ringing in the||
7186|086|S|ears), mental/mood changes, easy bleeding/bruising,||
7186|087|S|difficult/painful swallowing, signs of kidney problems (such as||
7186|088|S|change in the amount of urine, pink/bloody urine), symptoms of||
7186|089|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
7186|090|S|unusual/sudden weight gain).||
7186|091|S|   Ketoprofen may rarely cause serious (possibly fatal) liver||
7186|092|S|disease. Get medical help right away if you have any symptoms of||
7186|093|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
7186|094|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
7186|095|S|urine.||
7186|096|S|   A very serious allergic reaction to this drug is rare.||
7186|097|S|However, get medical help right away if you notice any symptoms||
7186|098|S|of a serious allergic reaction, including: fever, swollen lymph||
7186|099|S|nodes, rash, itching/swelling (especially of the||
7186|100|S|face/tongue/throat), severe dizziness, trouble breathing.||
7186|101|S|   This is not a complete list of possible side effects. If you||
7186|102|S|notice other effects not listed above, contact your doctor or||
7186|103|S|pharmacist.||
7186|104|S|   In the US -||
7186|105|S|   Call your doctor for medical advice about side effects. You||
7186|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7186|107|S|www.fda.gov/medwatch.||
7186|108|S|   In Canada - Call your doctor for medical advice about side||
7186|109|S|effects. You may report side effects to Health Canada at||
7186|110|S|1-866-234-2345.||
7186|111|B|||
7186|112|P|PRECAUTIONS:  See also Warning section.||
7186|113|P|   Before taking ketoprofen, tell your doctor or pharmacist if||
7186|114|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
7186|115|P|ibuprofen, naproxen, celecoxib); or if you have any other||
7186|116|P|allergies. This product may contain inactive ingredients, which||
7186|117|P|can cause allergic reactions or other problems. Talk to your||
7186|118|P|pharmacist for more details.||
7186|119|P|   Before taking this medication, tell your doctor or pharmacist||
7186|120|P|your medical history, especially of: asthma (including a history||
7186|121|P|of worsening breathing after taking aspirin or other NSAIDs),||
7186|122|P|bleeding/clotting problems, blood disorders (such as anemia),||
7186|123|P|growths in the nose (nasal polyps), heart disease (such as||
7186|124|P|previous heart attack), high blood pressure, liver disease,||
7186|125|P|stroke, swelling (edema, fluid retention),||
7186|126|P|stomach/intestinal/esophagus problems (such as bleeding,||
7186|127|P|heartburn, ulcers).||
7186|128|P|   Kidney problems can sometimes occur with the use of NSAID||
7186|129|P|medications, including ketoprofen. Problems are more likely to||
7186|130|P|occur if you are dehydrated, have heart failure or kidney||
7186|131|P|disease, are an older adult, or if you take certain medications||
7186|132|P|(see also Drug Interactions section). Drink plenty of fluids as||
7186|133|P|directed by your doctor to prevent dehydration and tell your||
7186|134|P|doctor right away if you have pink/bloody urine or any unusual||
7186|135|P|change in the amount of urine.||
7186|136|P|   This drug may make you dizzy or drowsy or cause blurred||
7186|137|P|vision. Alcohol or marijuana (cannabis) can make these effects||
7186|138|P|worse. Do not drive, use machinery, or do anything that needs||
7186|139|P|alertness or clear vision until you can do it safely. Limit||
7186|140|P|alcoholic beverages. Talk to your doctor if you are using||
7186|141|P|marijuana (cannabis).||
7186|142|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
7186|143|P|and tobacco, especially when combined with this medicine, may||
7186|144|P|increase your risk for stomach bleeding. Limit alcohol and stop||
7186|145|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
7186|146|P|may safely drink.||
7186|147|P|   This medication may make you more sensitive to the sun. Limit||
7186|148|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
7186|149|P|sunscreen and wear protective clothing when outdoors. Tell your||
7186|150|P|doctor right away if you get sunburned or have skin||
7186|151|P|blisters/redness.||
7186|152|P|   Before having surgery, tell your doctor or dentist about all||
7186|153|P|the products you use (including prescription drugs,||
7186|154|P|nonprescription drugs, and herbal products).||
7186|155|P|   Older adults may be at greater risk for stomach/intestinal||
7186|156|P|bleeding, kidney problems, heart attack, and stroke while using||
7186|157|P|this drug.||
7186|158|P|   Before using this medication, women of childbearing age should||
7186|159|P|talk with their doctor(s) about the benefits and risks. Tell your||
7186|160|P|doctor if you are pregnant or if you plan to become pregnant.||
7186|161|P|This medication may harm an unborn baby and cause problems with||
7186|162|P|normal labor/delivery. It is not recommended for use in pregnancy||
7186|163|P|from 20 weeks until delivery. If your doctor decides that you||
7186|164|P|need to use this medication between 20 and 30 weeks of pregnancy,||
7186|165|P|you should use the lowest effective dose for the shortest||
7186|166|P|possible time. You should not use this medication after 30 weeks||
7186|167|P|of pregnancy.||
7186|168|P|   This drug passes into breast milk. Consult your doctor before||
7186|169|P|breastfeeding.||
7186|170|B|||
7186|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7186|172|I|medications work or increase your risk for serious side effects.||
7186|173|I|This document does not contain all possible drug interactions.||
7186|174|I|Keep a list of all the products you use (including||
7186|175|I|prescription/nonprescription drugs and herbal products) and share||
7186|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
7186|177|I|the dosage of any medicines without your doctor's approval.||
7186|178|I|   Some products that may interact with this drug are: aliskiren,||
7186|179|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
7186|180|I|receptor blockers (such as losartan, valsartan), cidofovir,||
7186|181|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
7186|182|I|methotrexate, "water pills" (diuretics such as furosemide).||
7186|183|I|   Other medications can affect the removal of ketoprofen from||
7186|184|I|your body, which may affect how ketoprofen works. An example is||
7186|185|I|probenecid, among others.||
7186|186|I|   This medication may increase the risk of bleeding when taken||
7186|187|I|with other drugs that also may cause bleeding. Examples include||
7186|188|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
7186|189|I|dabigatran/enoxaparin/warfarin, among others.||
7186|190|I|   Check all prescription and nonprescription medicine labels||
7186|191|I|carefully since many medications contain pain relievers/fever||
7186|192|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
7186|193|I|naproxen). These drugs are similar to ketoprofen and may increase||
7186|194|I|your risk of side effects if taken together. However, if your||
7186|195|I|doctor has told you to take low-dose aspirin to prevent heart||
7186|196|I|attack or stroke (usually 81-162 milligrams a day), you should||
7186|197|I|keep taking the aspirin unless your doctor tells you not to. Ask||
7186|198|I|your doctor or pharmacist for more details.||
7186|199|B|||
7186|200|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7186|201|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7186|202|O|poison control center right away. US residents can call||
7186|203|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7186|204|O|Symptoms of overdose may include: severe stomach pain,||
7186|205|O|slow/shallow breathing, extreme drowsiness, seizure.||
7186|206|B|||
7186|207|N|NOTES:  Do not share this medication with others.||
7186|208|N|   Lab and/or medical tests (such as complete blood count,||
7186|209|N|liver/kidney function, blood pressure) may be done while you are||
7186|210|N|using this medication. Keep all medical and lab appointments.||
7186|211|N|Consult your doctor for more details.||
7186|212|N|   Lifestyle changes (such as weight loss if needed,||
7186|213|N|strengthening/conditioning exercises) may help improve your||
7186|214|N|flexibility and joint function. Consult your doctor for specific||
7186|215|N|instructions.||
7186|216|B|||
7186|217|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7186|218|D|remember. If it is near the time of the next dose, skip the||
7186|219|D|missed dose. Take your next dose at the regular time. Do not||
7186|220|D|double the dose to catch up.||
7186|221|B|||
7186|222|R|STORAGE:  Store at room temperature away from light and moisture.||
7186|223|R|Do not store in the bathroom. Keep all medications away from||
7186|224|R|children and pets.||
7186|225|R|   Do not flush medications down the toilet or pour them into a||
7186|226|R|drain unless instructed to do so. Properly discard this product||
7186|227|R|when it is expired or no longer needed. Consult your pharmacist||
7186|228|R|or local waste disposal company.||
7186|229|B|||
7186|230|A|Information last revised August 2025.||
7186|231|A|Copyright(c) 2025 First Databank, Inc.||
7186|232|B|||
7187|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7187|002|Z|does NOT have all possible information about this product. This||
7187|003|Z|information does not assure that this product is safe, effective,||
7187|004|Z|or appropriate for you. This information is not individual||
7187|005|Z|medical advice and does not substitute for the advice of your||
7187|006|Z|health care professional. Always ask your health care||
7187|007|Z|professional for complete information about this product and your||
7187|008|Z|specific health needs.||
7187|009|B|||
7187|010|T|DEFEROXAMINE - INJECTION||
7187|011|F|(deff-er-OX-uh-meen)||
7187|012|B|||
7187|013|C|COMMON BRAND NAME(S): Desferal||
7187|014|B|||
7187|015|U|USES:  This medication is used along with other treatments (such||
7187|016|U|as causing vomiting with syrup of ipecac, stomach pumping) to||
7187|017|U|treat sudden iron poisoning. It is most effective when given as||
7187|018|U|soon as possible after the iron was eaten. This medication can||
7187|019|U|also be used to help get rid of iron in patients with high iron||
7187|020|U|levels due to many blood transfusions. Deferoxamine is an||
7187|021|U|iron-binding agent that belongs to a class of drugs known as||
7187|022|U|heavy metal antagonists. It works by helping the kidneys and||
7187|023|U|gallbladder get rid of the extra iron.||
7187|024|U|   This medication is not recommended for use in children less||
7187|025|U|than 3 years old (see also Precautions section).||
7187|026|B|||
7187|027|V|OTHER USES:  This section contains uses of this drug that are not||
7187|028|V|listed in the approved professional labeling for the drug but||
7187|029|V|that may be prescribed by your health care professional. Use this||
7187|030|V|drug for a condition that is listed in this section only if it||
7187|031|V|has been so prescribed by your health care professional.||
7187|032|V|   This drug may also be used for high levels of aluminum in||
7187|033|V|dialysis patients and people with aluminum poisoning.||
7187|034|B|||
7187|035|H|HOW TO USE:  Depending upon your medical condition, this||
7187|036|H|medication is injected directly into a muscle, under the skin, or||
7187|037|H|into a vein as directed by your doctor. The dosage is based on||
7187|038|H|your medical condition and response to treatment.||
7187|039|H|   If you are giving this medication to yourself at home, learn||
7187|040|H|all preparation and usage instructions from your health care||
7187|041|H|professional. Before using, check this product for particles or||
7187|042|H|discoloration. If either is present, do not use the liquid. Learn||
7187|043|H|how to store and discard medical supplies safely.||
7187|044|H|   If you are using this medication to treat high iron levels,||
7187|045|H|your doctor may direct you to take vitamin C (ascorbic acid)||
7187|046|H|after you have been using this medication for at least 1 month.||
7187|047|H|Taking vitamin C will help replace the loss of vitamin C due to||
7187|048|H|high iron levels and help the medication work to get rid of the||
7187|049|H|iron. If you have heart disease (such as heart failure), tell||
7187|050|H|your doctor before taking vitamin C while using this medication||
7187|051|H|(see also Drug Interactions). The manufacturer recommends that||
7187|052|H|adults using this drug take no more than 200 milligrams of||
7187|053|H|vitamin C a day.||
7187|054|H|   Tell your doctor if your condition lasts or gets worse.||
7187|055|B|||
7187|056|S|SIDE EFFECTS:  Pain and swelling at the injection site or blurred||
7187|057|S|vision may occur. If any of these effects last or get worse, tell||
7187|058|S|your doctor or pharmacist promptly.||
7187|059|S|   This medicine may cause your urine to turn reddish. This||
7187|060|S|effect is harmless.||
7187|061|S|   When this medication is given into a vein, flushing, severe||
7187|062|S|itching, severe dizziness, fast heartbeat, and fainting can||
7187|063|S|occur. The manufacturer recommends that, when possible, this||
7187|064|S|medication be given either in the muscle or under the skin.||
7187|065|S|   Remember that this medication has been prescribed because your||
7187|066|S|doctor has judged that the benefit to you is greater than the||
7187|067|S|risk of side effects. Many people using this medication do not||
7187|068|S|have serious side effects.||
7187|069|S|   Tell your doctor right away if you have any serious side||
7187|070|S|effects, including: other vision changes (such as vision loss,||
7187|071|S|loss of color vision, cataracts), eye pain, hearing changes (such||
7187|072|S|as ringing ears, decreased hearing/loss).||
7187|073|S|   Rarely, this drug may cause serious (sometimes fatal)||
7187|074|S|bacterial or fungal infections. Get medical help right away if||
7187|075|S|you notice any of the following: unexplained diarrhea/abdominal||
7187|076|S|pain/fever.||
7187|077|S|   This drug may rarely cause a serious (rarely fatal) lung||
7187|078|S|condition (acute respiratory distress syndrome or ARDS). Get||
7187|079|S|medical help right away if you notice any of the following:||
7187|080|S|sudden/severe shortness of breath, labored or rapid breathing,||
7187|081|S|severe dizziness.||
7187|082|S|   A very serious allergic reaction to this drug is rare.||
7187|083|S|However, get medical help right away if you notice any symptoms||
7187|084|S|of a serious allergic reaction, including: rash, itching/swelling||
7187|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7187|086|S|breathing.||
7187|087|S|   This is not a complete list of possible side effects. If you||
7187|088|S|notice other effects not listed above, contact your doctor or||
7187|089|S|pharmacist.||
7187|090|S|   In the US -||
7187|091|S|   Call your doctor for medical advice about side effects. You||
7187|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7187|093|S|www.fda.gov/medwatch.||
7187|094|S|   In Canada - Call your doctor for medical advice about side||
7187|095|S|effects. You may report side effects to Health Canada at||
7187|096|S|1-866-234-2345.||
7187|097|B|||
7187|098|P|PRECAUTIONS:  Before using deferoxamine, tell your doctor or||
7187|099|P|pharmacist if you are allergic to it; or if you have any other||
7187|100|P|allergies. This product may contain inactive ingredients, which||
7187|101|P|can cause allergic reactions or other problems. Talk to your||
7187|102|P|pharmacist for more details.||
7187|103|P|   Before using this medication, tell your doctor or pharmacist||
7187|104|P|your medical history, especially of: kidney problems, rheumatoid||
7187|105|P|arthritis, diabetes, any fungal infection.||
7187|106|P|   If you are using this medication for aluminum poisoning, also||
7187|107|P|tell your doctor or pharmacist if you have: seizures, decreased||
7187|108|P|calcium levels in the blood, hyperparathyroidism.||
7187|109|P|   This drug may make you dizzy or blur your vision. Alcohol or||
7187|110|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
7187|111|P|machinery, or do anything that needs alertness or clear vision||
7187|112|P|until you can do it safely. Limit alcoholic beverages. Talk to||
7187|113|P|your doctor if you are using marijuana (cannabis).||
7187|114|P|   Children (especially those younger than 3 years of age) may be||
7187|115|P|more sensitive to the side effects of this drug, especially the||
7187|116|P|effects on bone growth.||
7187|117|P|   Older adults may be more sensitive to the side effects of this||
7187|118|P|drug, especially vision/hearing problems.||
7187|119|P|   During pregnancy, this medication should be used only when||
7187|120|P|clearly needed. It may harm an unborn baby. Ask about reliable||
7187|121|P|forms of birth control while using this medication and for 1||
7187|122|P|month after the last dose. Discuss the risks and benefits with||
7187|123|P|your doctor.||
7187|124|P|   It is unknown if this medication passes into breast milk.||
7187|125|P|Because of the possible risk to the infant, breastfeeding is not||
7187|126|P|recommended while using this medication and for 1 week after the||
7187|127|P|last dose. Consult your doctor before breastfeeding.||
7187|128|B|||
7187|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7187|130|I|medications work or increase your risk for serious side effects.||
7187|131|I|This document does not contain all possible drug interactions.||
7187|132|I|Keep a list of all the products you use (including||
7187|133|I|prescription/nonprescription drugs and herbal products) and share||
7187|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
7187|135|I|the dosage of any medicines without your doctor's approval.||
7187|136|I|   A product that may interact with this drug is:||
7187|137|I|prochlorperazine.||
7187|138|I|   If you have a certain heart problem (heart failure), this drug||
7187|139|I|should not be used with vitamin C (ascorbic acid) because very||
7187|140|I|serious interactions may occur. Consult your doctor or pharmacist||
7187|141|I|for more details before starting deferoxamine.||
7187|142|I|   This medication may interfere with certain lab tests (such as||
7187|143|I|gallium scintigraphy), possibly causing false test results. Make||
7187|144|I|sure lab personnel and all your doctors know you use this drug.||
7187|145|B|||
7187|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7187|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7187|148|O|poison control center right away. US residents can call||
7187|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7187|150|O|Symptoms of overdose may include: severe dizziness, fainting,||
7187|151|O|fast heartbeat, loss of vision, sudden paleness in||
7187|152|O|face/lips/palms of hands, coma.||
7187|153|B|||
7187|154|N|NOTES:  Do not share this medication with others.||
7187|155|N|   In patients receiving this medication long-term, lab and/or||
7187|156|N|medical tests (such as eye exams, hearing tests, growth and body||
7187|157|N|weight in children, kidney function, heart function in patients||
7187|158|N|using deferoxamine and vitamin C) should be done while you are||
7187|159|N|using this medication. Keep all medical and lab appointments.||
7187|160|N|Consult your doctor for more details.||
7187|161|B|||
7187|162|D|MISSED DOSE:  It is important to get each dose of this medication||
7187|163|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7187|164|D|right away for a new dosing schedule. Do not double the dose to||
7187|165|D|catch up.||
7187|166|B|||
7187|167|R|STORAGE:  Store unmixed vials at room temperature away from||
7187|168|R|light. After mixing, use within time period indicated in product||
7187|169|R|instructions. Discard unused portion. Keep all medications away||
7187|170|R|from children and pets.||
7187|171|R|   Do not flush medications down the toilet or pour them into a||
7187|172|R|drain unless instructed to do so. Properly discard this product||
7187|173|R|when it is expired or no longer needed. Consult your pharmacist||
7187|174|R|or local waste disposal company.||
7187|175|B|||
7187|176|A|Information last revised October 2024.||
7187|177|A|Copyright(c) 2025 First Databank, Inc.||
7187|178|B|||
7193|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7193|002|Z|does NOT have all possible information about this product. This||
7193|003|Z|information does not assure that this product is safe, effective,||
7193|004|Z|or appropriate for you. This information is not individual||
7193|005|Z|medical advice and does not substitute for the advice of your||
7193|006|Z|health care professional. Always ask your health care||
7193|007|Z|professional for complete information about this product and your||
7193|008|Z|specific health needs.||
7193|009|B|||
7193|010|T|SALICYLIC ACID/SULFUR SHAMPOO - TOPICAL||
7193|011|F|(SAL-i-SIL-ik AS-id/SULL-fur)||
7193|012|B|||
7193|013|C|COMMON BRAND NAME(S): Sebex, Sebulex||
7193|014|B|||
7193|015|U|USES:  This medication is used to treat dandruff and other scalp||
7193|016|U|conditions (such as itching, scaling, flaking). Salicylic acid||
7193|017|U|and sulfur are known as keratolytic agents. This type of drug||
7193|018|U|causes the skin to shed dead cells from its top layer by||
7193|019|U|increasing the amount of moisture in the skin and dissolving the||
7193|020|U|substance that makes the cells clump together. This effect makes||
7193|021|U|it easier to shed the skin cells, softens the top layer of skin,||
7193|022|U|and decreases scaling and dryness. Salicylic acid belongs to the||
7193|023|U|same class of drugs as aspirin (salicylates).||
7193|024|B|||
7193|025|H|HOW TO USE:  Follow all directions on the product package, or use||
7193|026|H|as directed by your doctor. If you have any questions, ask your||
7193|027|H|doctor or pharmacist.||
7193|028|H|   Shake the container well before use. Wet hair and scalp with||
7193|029|H|water. Apply shampoo to scalp. Rub into the scalp well, working||
7193|030|H|the shampoo into a lather. Leave on the scalp for 5 minutes and||
7193|031|H|then rinse off. Shampoo again as directed and rinse well. Use the||
7193|032|H|shampoo daily or every other day or as directed by your doctor.||
7193|033|H|Once your condition has improved, you may need to use this||
7193|034|H|product only occasionally (1 to 2 times a week).||
7193|035|H|   This medication should be used on the skin/scalp only. Do not||
7193|036|H|use on cut/scraped skin. Be careful to avoid your eyes. If||
7193|037|H|contact occurs, flush the affected eye(s) with cool water for 15||
7193|038|H|minutes.||
7193|039|H|   Do not use large amounts of this medication, apply it more||
7193|040|H|often, or use it for a longer time than directed. Your condition||
7193|041|H|will not clear faster, but the chance for side effects may be||
7193|042|H|increased.||
7193|043|H|   You should see some improvement after 2 or 3 treatments. Tell||
7193|044|H|your doctor if your condition lasts or gets worse. If you think||
7193|045|H|you may have a serious medical problem, get medical help right||
7193|046|H|away.||
7193|047|B|||
7193|048|S|SIDE EFFECTS:  Burning, redness, and peeling skin near the||
7193|049|S|treated area may occur. If any of these effects last or get||
7193|050|S|worse, tell your doctor or pharmacist promptly.||
7193|051|S|   If your doctor has directed you to use this medication,||
7193|052|S|remember that your doctor has judged that the benefit to you is||
7193|053|S|greater than the risk of side effects. Many people using this||
7193|054|S|medication do not have serious side effects.||
7193|055|S|   Stop using this medication and tell your doctor right away if||
7193|056|S|you have any serious side effects, including: severe||
7193|057|S|redness/blistering/peeling of the scalp.||
7193|058|S|   A very serious allergic reaction to this drug is rare.||
7193|059|S|However, get medical help right away if you notice any symptoms||
7193|060|S|of a serious allergic reaction, including: rash, itching/swelling||
7193|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7193|062|S|breathing.||
7193|063|S|   This is not a complete list of possible side effects. If you||
7193|064|S|notice other effects not listed above, contact your doctor or||
7193|065|S|pharmacist.||
7193|066|S|   In the US -||
7193|067|S|   Call your doctor for medical advice about side effects. You||
7193|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7193|069|S|www.fda.gov/medwatch.||
7193|070|S|   In Canada - Call your doctor for medical advice about side||
7193|071|S|effects. You may report side effects to Health Canada at||
7193|072|S|1-866-234-2345.||
7193|073|B|||
7193|074|P|PRECAUTIONS:  Before using this product, tell your doctor or||
7193|075|P|pharmacist if you are allergic to salicylic acid or sulfur; or to||
7193|076|P|aspirin; or if you have any other allergies. This product may||
7193|077|P|contain inactive ingredients (such as fragrance), which can cause||
7193|078|P|allergic reactions or other problems. Talk to your pharmacist for||
7193|079|P|more details.||
7193|080|P|   Before using this product, consult your doctor or pharmacist||
7193|081|P|if you have any of the following health problems: cuts/open||
7193|082|P|wounds on the scalp.||
7193|083|P|   During pregnancy, this product should be used only when||
7193|084|P|clearly needed. Discuss the risks and benefits with your doctor.||
7193|085|P|   It is unknown if this medication passes into breast milk.||
7193|086|P|Consult your doctor before breastfeeding.||
7193|087|B|||
7193|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7193|089|I|medications work or increase your risk for serious side effects.||
7193|090|I|This document does not contain all possible drug interactions.||
7193|091|I|Keep a list of all the products you use (including||
7193|092|I|prescription/nonprescription drugs and herbal products) and share||
7193|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
7193|094|I|the dosage of any medicines without your doctor's approval.||
7193|095|B|||
7193|096|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7193|097|O|has overdosed and has serious symptoms such as passing out or||
7193|098|O|trouble breathing, call 911. Otherwise, call a poison control||
7193|099|O|center right away. US residents can call 1-800-222-1222. Canada||
7193|100|O|residents can call 1-844-764-7669. Symptoms of overdose may||
7193|101|O|include: nausea, vomiting, dizziness, hearing problems,||
7193|102|O|tiredness, fast breathing.||
7193|103|B|||
7193|104|N|NOTES:  Avoid getting this medication on clothing, wood, plastic,||
7193|105|N|metal, or other surfaces because it can cause damage.||
7193|106|B|||
7193|107|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7193|108|D|If it is near the time of the next dose, skip the missed dose.||
7193|109|D|Use your next dose at the regular time. Do not double the dose to||
7193|110|D|catch up.||
7193|111|B|||
7193|112|R|STORAGE:  Different brands of this medication have different||
7193|113|R|storage needs. Check the product package for instructions on how||
7193|114|R|to store your brand, or ask your pharmacist. Keep all medications||
7193|115|R|away from children and pets.||
7193|116|R|   Do not flush medications down the toilet or pour them into a||
7193|117|R|drain unless instructed to do so. Properly discard this product||
7193|118|R|when it is expired or no longer needed. Consult your pharmacist||
7193|119|R|or local waste disposal company.||
7193|120|B|||
7193|121|A|Information last revised December 2024.||
7193|122|A|Copyright(c) 2025 First Databank, Inc.||
7193|123|B|||
7195|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7195|002|Z|does NOT have all possible information about this product. This||
7195|003|Z|information does not assure that this product is safe, effective,||
7195|004|Z|or appropriate for you. This information is not individual||
7195|005|Z|medical advice and does not substitute for the advice of your||
7195|006|Z|health care professional. Always ask your health care||
7195|007|Z|professional for complete information about this product and your||
7195|008|Z|specific health needs.||
7195|009|B|||
7195|010|T|GUAIFENESIN/OPIOID ANTITUSSIVE/ANTIHISTAMINE - ORAL||
7195|011|B|||
7195|012|W|WARNING:  This medication has a risk for abuse and addiction,||
7195|013|W|which can lead to overdose and death. This medication may also||
7195|014|W|cause severe, possibly fatal, breathing problems. To lower your||
7195|015|W|risk, your doctor should have you take the smallest dose that||
7195|016|W|works, and take it for the shortest possible time. See also How||
7195|017|W|to Use section for more information about addiction.||
7195|018|W|   The risk for severe breathing problems is higher when you||
7195|019|W|start this medication, or if you take the wrong dose or take more||
7195|020|W|of this medication than prescribed. Taking this medication with||
7195|021|W|alcohol or other drugs that can cause drowsiness or breathing||
7195|022|W|problems may cause very serious side effects, including death.||
7195|023|W|Also, other medications can affect the removal of this product||
7195|024|W|from your body, which may affect how it works. Be sure you know||
7195|025|W|how to take this product and what other drugs you should avoid||
7195|026|W|taking with it. See also Drug Interactions section. Get medical||
7195|027|W|help right away if any of these very serious side effects occur:||
7195|028|W|slow/shallow breathing, unusual lightheadedness, severe||
7195|029|W|drowsiness/dizziness, difficulty waking up.||
7195|030|W|   Keep this medicine in a safe place to prevent theft, misuse,||
7195|031|W|or abuse. If someone accidentally swallows this drug, get medical||
7195|032|W|help right away.||
7195|033|W|   Before using this medication, women of childbearing age should||
7195|034|W|talk with their doctor(s) about the risks and benefits. Tell your||
7195|035|W|doctor if you are pregnant or think you may be pregnant. During||
7195|036|W|pregnancy, this medication is not recommended. It may slightly||
7195|037|W|increase the risk of birth defects if used during the first two||
7195|038|W|months of pregnancy. Also, using it for a long time or in high||
7195|039|W|doses near the expected delivery date may harm the unborn baby.||
7195|040|W|To lessen the risk, take the smallest effective dose for the||
7195|041|W|shortest possible time. Babies born to mothers who use this drug||
7195|042|W|for a long time may develop severe (possibly fatal) withdrawal||
7195|043|W|symptoms. Tell the doctor right away if you notice any symptoms||
7195|044|W|in your newborn baby such as crying that doesn't stop,||
7195|045|W|slow/shallow breathing, irritability, shaking, vomiting,||
7195|046|W|diarrhea, poor feeding, or difficulty gaining weight.||
7195|047|B|||
7195|048|U|USES:  This combination medication is used to treat symptoms||
7195|049|U|caused by the common cold, flu, allergies, hay fever, and other||
7195|050|U|breathing illnesses (such as sinusitis, bronchitis). Guaifenesin||
7195|051|U|is an expectorant that helps thin and loosen mucus in the lungs,||
7195|052|U|making it easier to cough up the mucus. This product also||
7195|053|U|contains an opioid cough suppressant (antitussive) that affects a||
7195|054|U|certain part of the brain, reducing the urge to cough.||
7195|055|U|Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny||
7195|056|U|nose, and sneezing.||
7195|057|U|   This medication is not usually used for ongoing coughs from||
7195|058|U|smoking, asthma, other long-term breathing problems (such as||
7195|059|U|emphysema), or coughs with a lot of mucus, unless directed by||
7195|060|U|your doctor.||
7195|061|U|   Opioid cough suppressants should not be used by children||
7195|062|U|younger than 18 years. Children are at higher risk for serious||
7195|063|U|(even fatal) side effects, especially breathing problems. Talk||
7195|064|U|with the doctor about the risks and benefits of this medication.||
7195|065|U|   Cough-and-cold products do not cure colds. Cough due to a||
7195|066|U|common cold often does not need to be treated with medicine. Ask||
7195|067|U|your doctor or pharmacist about other ways to relieve cough and||
7195|068|U|cold symptoms, such as drinking enough fluids, using a||
7195|069|U|humidifier, or saline nose drops/spray.||
7195|070|B|||
7195|071|H|HOW TO USE:  Take this medication by mouth with or without food||
7195|072|H|with a full glass of water (8 ounces or 240 milliliters) as||
7195|073|H|directed by your doctor. This medication may be taken with food||
7195|074|H|or milk if stomach upset occurs. Carefully measure the dose using||
7195|075|H|a special measuring device/spoon. Do not use a household spoon||
7195|076|H|because you may not get the correct dose.||
7195|077|H|   Do not increase your dose or use this product more often or||
7195|078|H|for longer than prescribed. Your condition will not improve any||
7195|079|H|faster, and your risk of side effects will increase.||
7195|080|H|   If you suddenly stop using this medication, you may have||
7195|081|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
7195|082|H|nose, nausea, sweating, muscle aches). To help prevent||
7195|083|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
7195|084|H|more likely if you have used this medication for a long time||
7195|085|H|(more than a few weeks) or in high doses. Tell your doctor or||
7195|086|H|pharmacist right away if you have withdrawal.||
7195|087|H|   Though it helps many people, this product may sometimes cause||
7195|088|H|addiction. This risk may be higher if you have a mental/mood||
7195|089|H|disorder or a substance use disorder (such as overuse of or||
7195|090|H|addiction to drugs/alcohol). Take this product exactly as||
7195|091|H|prescribed to lower the risk of addiction. Ask your doctor or||
7195|092|H|pharmacist for more details.||
7195|093|H|   When used for an extended time, this medication may not work||
7195|094|H|as well and may require different dosing. Talk with your doctor||
7195|095|H|if this medication stops working well.||
7195|096|H|   Tell your doctor if your cough does not get better in 5 days.||
7195|097|H|Also, tell your doctor if your condition gets worse, or if you||
7195|098|H|have a headache that doesn't go away, fever, or rash. These may||
7195|099|H|be symptoms of a serious medical problem and should be checked by||
7195|100|H|a doctor.||
7195|101|B|||
7195|102|S|SIDE EFFECTS:  See also Warning section.||
7195|103|S|   Drowsiness, dizziness, headache, blurred vision, upset||
7195|104|S|stomach, nausea, constipation, or dry mouth/nose/throat may||
7195|105|S|occur. If any of these effects last or get worse, tell your||
7195|106|S|doctor or pharmacist promptly.||
7195|107|S|   To reduce the risk of dizziness and lightheadedness, get up||
7195|108|S|slowly when rising from a sitting or lying position.||
7195|109|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
7195|110|S|chips, chew (sugarless) gum, drink water, or use a saliva||
7195|111|S|substitute. This medication can dry up and thicken mucus in your||
7195|112|S|lungs, making it more difficult to breathe and clear your lungs.||
7195|113|S|To help prevent this effect, drink plenty of fluids unless||
7195|114|S|otherwise directed by your doctor.||
7195|115|S|   Remember that this medication has been prescribed because your||
7195|116|S|doctor has judged that the benefit to you is greater than the||
7195|117|S|risk of side effects. Many people using this medication do not||
7195|118|S|have serious side effects.||
7195|119|S|   Tell your doctor right away if you have any serious side||
7195|120|S|effects, including: interrupted breathing during sleep (sleep||
7195|121|S|apnea), mental/mood changes (such as hallucinations), ringing in||
7195|122|S|the ears, trouble urinating, easy bruising/bleeding,||
7195|123|S|fast/slow/irregular heartbeat, trouble swallowing.||
7195|124|S|   Get medical help right away if you have any very serious side||
7195|125|S|effects, including: seizures.||
7195|126|S|   This product may cause serious mental/mood changes and very||
7195|127|S|serious (rarely fatal) breathing problems. This product may||
7195|128|S|contain codeine or dihydrocodeine. Codeine and dihydrocodeine are||
7195|129|S|changed into strong opioid drugs (morphine or dihydromorphine) in||
7195|130|S|your body. In some people this happens faster and more completely||
7195|131|S|than usual, which increases the risk of very serious side||
7195|132|S|effects. Get medical help right away if you notice any of the||
7195|133|S|following: slow/shallow breathing, severe drowsiness/difficulty||
7195|134|S|waking up, confusion.||
7195|135|S|   A very serious allergic reaction to this drug is rare.||
7195|136|S|However, get medical help right away if you notice any symptoms||
7195|137|S|of a serious allergic reaction, including: rash, itching/swelling||
7195|138|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7195|139|S|breathing.||
7195|140|S|   This is not a complete list of possible side effects. If you||
7195|141|S|notice other effects not listed above, contact your doctor or||
7195|142|S|pharmacist.||
7195|143|S|   In the US -||
7195|144|S|   Call your doctor for medical advice about side effects. You||
7195|145|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7195|146|S|www.fda.gov/medwatch.||
7195|147|S|   In Canada - Call your doctor for medical advice about side||
7195|148|S|effects. You may report side effects to Health Canada at||
7195|149|S|1-866-234-2345.||
7195|150|B|||
7195|151|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
7195|152|P|pharmacist if you are allergic to any of its ingredients; or if||
7195|153|P|you have any other allergies. This product may contain inactive||
7195|154|P|ingredients, which can cause allergic reactions or other||
7195|155|P|problems. Talk to your pharmacist for more details.||
7195|156|P|   Before using this medication, tell your doctor or pharmacist||
7195|157|P|your medical history, especially of: abdominal problems (such as||
7195|158|P|chronic constipation, ileus, gallbladder disease, pancreatitis),||
7195|159|P|adrenal gland problem (such as Addison's disease), certain brain||
7195|160|P|disorders (such as head injury, tumor, increased intracranial||
7195|161|P|pressure), breathing problems (such as asthma, emphysema, sleep||
7195|162|P|apnea), diabetes, a certain eye problem (glaucoma), heart||
7195|163|P|problems, high blood pressure, kidney problems, liver disease,||
7195|164|P|mental/mood problems (such as depression, psychosis), seizures,||
7195|165|P|stomach/intestinal problems (such as ulcers, blockage), thyroid||
7195|166|P|problems (such as hypothyroidism, hyperthyroidism), urination||
7195|167|P|problems (such as trouble urinating due to enlarged prostate,||
7195|168|P|urinary retention), personal or family history of a substance use||
7195|169|P|disorder (such as overuse of or addiction to drugs/alcohol),||
7195|170|P|obesity.||
7195|171|P|   This drug may make you dizzy or drowsy or blur your vision.||
7195|172|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7195|173|P|drowsy. Do not drive, use machinery, or do anything that needs||
7195|174|P|alertness or clear vision until you can do it safely. Avoid||
7195|175|P|alcoholic beverages. Talk to your doctor if you are using||
7195|176|P|marijuana (cannabis).||
7195|177|P|   This medicine may contain aspartame. If you have||
7195|178|P|phenylketonuria (PKU) or any other condition that requires you to||
7195|179|P|restrict your intake of aspartame (or phenylalanine), consult||
7195|180|P|your doctor or pharmacist regarding the safe use of this||
7195|181|P|medicine.||
7195|182|P|   This medication may contain sugar and/or alcohol. Caution is||
7195|183|P|advised if you have diabetes, alcohol dependence, or liver||
7195|184|P|disease. Ask your doctor or pharmacist about the safe use of this||
7195|185|P|product.||
7195|186|P|   Before having surgery, tell your doctor or dentist about all||
7195|187|P|the products you use (including prescription drugs,||
7195|188|P|nonprescription drugs, and herbal products).||
7195|189|P|   Older adults may be more sensitive to the side effects of this||
7195|190|P|drug, especially confusion, dizziness, drowsiness, and||
7195|191|P|slow/shallow breathing.||
7195|192|P|   Tell your doctor if you are pregnant or think you may be||
7195|193|P|pregnant. During pregnancy, this product is not recommended. It||
7195|194|P|may harm an unborn baby. Talk to your doctor about the risks and||
7195|195|P|benefits of this medication. See also Warning section.||
7195|196|P|   This product may pass into breast milk and may have||
7195|197|P|undesirable effects on a nursing infant (such as unusual||
7195|198|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
7195|199|P|limpness). Consult your doctor before breastfeeding.||
7195|200|B|||
7195|201|I|DRUG INTERACTIONS:  See also Warning section.||
7195|202|I|   Drug interactions may change how your medications work or||
7195|203|I|increase your risk for serious side effects. This document does||
7195|204|I|not contain all possible drug interactions. Keep a list of all||
7195|205|I|the products you use (including prescription/nonprescription||
7195|206|I|drugs and herbal products) and share it with your doctor and||
7195|207|I|pharmacist. Do not start, stop, or change the dosage of any||
7195|208|I|medicines without your doctor's approval.||
7195|209|I|   Some products that may interact with this drug include:||
7195|210|I|antihistamines applied to the skin (such as diphenhydramine||
7195|211|I|cream, ointment, spray), naltrexone, samidorphan.||
7195|212|I|   Guaifenesin is available in both prescription and||
7195|213|I|nonprescription products. Check the labels on all your||
7195|214|I|medications carefully to make sure you are not taking more than||
7195|215|I|one guaifenesin-containing product.||
7195|216|I|   The risk of serious side effects (such as slow/shallow||
7195|217|I|breathing, severe drowsiness/dizziness) may be increased if this||
7195|218|I|medication is taken with other products that may also cause||
7195|219|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
7195|220|I|if you are taking other products such as other opioid pain or||
7195|221|I|cough relievers (such as codeine, hydrocodone), alcohol,||
7195|222|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
7195|223|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
7195|224|I|carisoprodol, cyclobenzaprine), or other antihistamines (such as||
7195|225|I|cetirizine, diphenhydramine).||
7195|226|I|   Check the labels on all your medicines (such as allergy or||
7195|227|I|cough-and-cold products) because they may contain ingredients||
7195|228|I|that cause drowsiness. Ask your pharmacist about using those||
7195|229|I|products safely.||
7195|230|I|   Other medications can affect the removal of this product from||
7195|231|I|your body, which may affect how this product works. Examples||
7195|232|I|include azole antifungals (such as ketoconazole), bupropion,||
7195|233|I|fluoxetine, macrolide antibiotics (such as erythromycin),||
7195|234|I|paroxetine, quinidine, rifamycins (such as rifabutin, rifampin),||
7195|235|I|ritonavir, certain drugs used to treat seizures (such as||
7195|236|I|carbamazepine, phenytoin), among others.||
7195|237|I|   This medication may interfere with certain lab tests (such as||
7195|238|I|5-HIAA levels, VMA levels, amylase/lipase levels, allergy skin||
7195|239|I|test), possibly causing false test results. Make sure lab||
7195|240|I|personnel and all your doctors know you use this drug.||
7195|241|B|||
7195|242|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7195|243|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7195|244|O|poison control center right away. US residents can call||
7195|245|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7195|246|O|Symptoms of overdose may include: confusion, cold/clammy skin,||
7195|247|O|fast/slow/irregular heartbeat, slow/shallow breathing, seizures,||
7195|248|O|coma.||
7195|249|B|||
7195|250|N|NOTES:  Do not share this medication with others. Sharing it is||
7195|251|N|against the law.||
7195|252|B|||
7195|253|D|MISSED DOSE:  If you are prescribed this medication on a regular||
7195|254|D|schedule and miss a dose, take it as soon as you remember. If it||
7195|255|D|is near the time of the next dose, skip the missed dose. Take||
7195|256|D|your next dose at the regular time. Do not double the dose to||
7195|257|D|catch up.||
7195|258|B|||
7195|259|R|STORAGE:  Store at room temperature away from light and moisture.||
7195|260|R|Do not store in the bathroom. Do not freeze. Keep all medications||
7195|261|R|away from children and pets.||
7195|262|R|   Do not flush medications down the toilet or pour them into a||
7195|263|R|drain unless instructed to do so. Properly discard this product||
7195|264|R|when it is expired or no longer needed. Consult your pharmacist||
7195|265|R|or local waste disposal company.||
7195|266|B|||
7195|267|A|Information last revised August 2025.||
7195|268|A|Copyright(c) 2025 First Databank, Inc.||
7195|269|B|||
7198|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7198|002|Z|does NOT have all possible information about this product. This||
7198|003|Z|information does not assure that this product is safe, effective,||
7198|004|Z|or appropriate for you. This information is not individual||
7198|005|Z|medical advice and does not substitute for the advice of your||
7198|006|Z|health care professional. Always ask your health care||
7198|007|Z|professional for complete information about this product and your||
7198|008|Z|specific health needs.||
7198|009|B|||
7198|010|T|EFLORNITHINE - TOPICAL||
7198|011|F|(eh-FLOOR-nith-een)||
7198|012|B|||
7198|013|C|COMMON BRAND NAME(S): Vaniqa||
7198|014|B|||
7198|015|U|USES:  This medication is used to slow down the growth of||
7198|016|U|unwanted hair on the face and under the chin in women. It should||
7198|017|U|not be used for hair on other parts of the body. It blocks a||
7198|018|U|certain natural substance (an enzyme) that is needed for hair||
7198|019|U|growth in the skin. This effect slows hair growth and may also||
7198|020|U|make the hair finer and lighter. It does not remove hair or cause||
7198|021|U|the hair to fall out.||
7198|022|U|   This drug is not for use in children younger than 12 years.||
7198|023|B|||
7198|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7198|025|H|from your pharmacist before you start using eflornithine and each||
7198|026|H|time you get a refill. If you have any questions, ask your doctor||
7198|027|H|or pharmacist.||
7198|028|H|   Apply a thin layer of this medication only to the affected||
7198|029|H|areas of the face and chin as directed by your doctor, usually||
7198|030|H|twice daily (at least 8 hours apart). Rub the medication in well.||
7198|031|H|Do not apply for at least 5 minutes after hair removal (such as||
7198|032|H|plucking, shaving). Do not wash the treated area for at least 4||
7198|033|H|hours.||
7198|034|H|   Wash hands immediately after using this product. This||
7198|035|H|medication is for use on the skin only. Avoid getting the product||
7198|036|H|in your eyes, nose, or mouth. If the medication gets in these||
7198|037|H|areas, rinse immediately with clean water. If this drug gets in||
7198|038|H|your eyes, rinse thoroughly with water and contact your doctor.||
7198|039|H|   Wait until the medication has dried completely before applying||
7198|040|H|cosmetics, moisturizers, or sunscreens over the treated areas.||
7198|041|H|   This product is not a hair removal product. Continue to use||
7198|042|H|hair removal techniques (such as shaving, plucking) while using||
7198|043|H|this medication. If you stop using this product, hair growth will||
7198|044|H|return.||
7198|045|H|   You should see some improvement in 4 to 8 weeks. This||
7198|046|H|medication works slowly. Use exactly as directed. Do not use more||
7198|047|H|of this product or use it more often. Your condition will not||
7198|048|H|improve faster, and the risk of side effects will increase. Tell||
7198|049|H|your doctor if your skin becomes red or irritated. Your doctor||
7198|050|H|may direct you to apply the medication only once a day or stop||
7198|051|H|the medication.||
7198|052|H|   Tell your doctor if your condition lasts or gets worse.||
7198|053|B|||
7198|054|S|SIDE EFFECTS:  Acne or burning, stinging, tingling, and redness||
7198|055|S|of the skin may occur. If any of these effects last or get worse,||
7198|056|S|tell your doctor.||
7198|057|S|   Remember that this medication has been prescribed because your||
7198|058|S|doctor has judged that the benefit to you is greater than the||
7198|059|S|risk of side effects. Many people using this medication do not||
7198|060|S|have serious side effects.||
7198|061|S|   Tell your doctor right away if you have any serious side||
7198|062|S|effects, including: small red bumps on the skin (folliculitis).||
7198|063|S|   A very serious allergic reaction to this drug is rare.||
7198|064|S|However, get medical help right away if you notice any symptoms||
7198|065|S|of a serious allergic reaction, including: rash, itching/swelling||
7198|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7198|067|S|breathing.||
7198|068|S|   This is not a complete list of possible side effects. If you||
7198|069|S|notice other effects not listed above, contact your doctor or||
7198|070|S|pharmacist.||
7198|071|S|   In the US -||
7198|072|S|   Call your doctor for medical advice about side effects. You||
7198|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7198|074|S|www.fda.gov/medwatch.||
7198|075|S|   In Canada - Call your doctor for medical advice about side||
7198|076|S|effects. You may report side effects to Health Canada at||
7198|077|S|1-866-234-2345.||
7198|078|B|||
7198|079|P|PRECAUTIONS:  Before using this product, tell your doctor or||
7198|080|P|pharmacist if you are allergic to eflornithine; or if you have||
7198|081|P|any other allergies. This product may contain inactive||
7198|082|P|ingredients (such as methylparaben), which can cause allergic||
7198|083|P|reactions or other problems. Talk to your pharmacist for more||
7198|084|P|details.||
7198|085|P|   Before using this medication, tell your doctor or pharmacist||
7198|086|P|your medical history, especially of: cuts/infections/sores on||
7198|087|P|face.||
7198|088|P|   Before having surgery, tell your doctor or dentist about all||
7198|089|P|the products you use (including prescription drugs,||
7198|090|P|nonprescription drugs, and herbal products).||
7198|091|P|   During pregnancy, this medication should be used only when||
7198|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
7198|093|P|   It is unknown if this drug passes into breast milk. Consult||
7198|094|P|your doctor before breastfeeding.||
7198|095|B|||
7198|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7198|097|I|medications work or increase your risk for serious side effects.||
7198|098|I|This document does not contain all possible drug interactions.||
7198|099|I|Keep a list of all the products you use (including||
7198|100|I|prescription/nonprescription drugs and herbal products) and share||
7198|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
7198|102|I|the dosage of any medicines without your doctor's approval.||
7198|103|B|||
7198|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7198|105|O|has overdosed and has serious symptoms such as passing out or||
7198|106|O|trouble breathing, call 911. Otherwise, call a poison control||
7198|107|O|center right away. US residents can call 1-800-222-1222. Canada||
7198|108|O|residents can call 1-844-764-7669.||
7198|109|B|||
7198|110|N|NOTES:  Do not share this medication with others.||
7198|111|B|||
7198|112|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
7198|113|D|remember. If it is near the time of the next dose, skip the||
7198|114|D|missed dose. Use your next dose at the regular time. Do not apply||
7198|115|D|more to catch up.||
7198|116|B|||
7198|117|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
7198|118|R|medications away from children and pets.||
7198|119|R|   Do not flush medications down the toilet or pour them into a||
7198|120|R|drain unless instructed to do so. Properly discard this product||
7198|121|R|when it is expired or no longer needed. Consult your pharmacist||
7198|122|R|or local waste disposal company.||
7198|123|B|||
7198|124|A|Information last revised May 2024.||
7198|125|A|Copyright(c) 2025 First Databank, Inc.||
7198|126|B|||
7202|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7202|002|Z|does NOT have all possible information about this product. This||
7202|003|Z|information does not assure that this product is safe, effective,||
7202|004|Z|or appropriate for you. This information is not individual||
7202|005|Z|medical advice and does not substitute for the advice of your||
7202|006|Z|health care professional. Always ask your health care||
7202|007|Z|professional for complete information about this product and your||
7202|008|Z|specific health needs.||
7202|009|B|||
7202|010|T|LACTULOSE (LIVER) - ORAL, RECTAL||
7202|011|F|(LACK-tew-lohss)||
7202|012|B|||
7202|013|C|COMMON BRAND NAME(S): Cephulac, Enulose||
7202|014|B|||
7202|015|U|USES:  This drug is used by mouth or rectally to treat or prevent||
7202|016|U|complications of liver disease (hepatic encephalopathy). It does||
7202|017|U|not cure the problem, but may help to improve mental status.||
7202|018|U|Lactulose is a colonic acidifier that works by decreasing the||
7202|019|U|amount of ammonia in the blood. It is a man-made sugar solution.||
7202|020|B|||
7202|021|V|OTHER USES:  This section contains uses of this drug that are not||
7202|022|V|listed in the approved professional labeling for the drug, but||
7202|023|V|may be prescribed by your health care professional. Use this drug||
7202|024|V|for a condition that is listed in this section only if has been||
7202|025|V|so prescribed by your health care professional.||
7202|026|V|   The form of this drug that is taken by mouth may also be used||
7202|027|V|for constipation.||
7202|028|B|||
7202|029|H|HOW TO USE:  If you are taking this medication by mouth for liver||
7202|030|H|disease, take it as directed by your doctor, usually 3 to 4 times||
7202|031|H|a day. To improve the taste, you may mix it into fruit juice,||
7202|032|H|water, milk, or a soft dessert. The goal is to have 2 to 3 soft||
7202|033|H|stools each day. The dosage is based on your medical condition||
7202|034|H|and response to treatment (for example, the number of soft stools||
7202|035|H|each day).||
7202|036|H|   If you are taking this medication by mouth for constipation,||
7202|037|H|take it as directed by your doctor, usually once daily.||
7202|038|H|   This medication can also be given rectally as an enema for||
7202|039|H|liver disease. Mix the recommended amount of lactulose with 700||
7202|040|H|milliliters (24 ounces) of water or normal saline. Give the||
7202|041|H|solution into the rectum and keep the liquid inside for 30 to 60||
7202|042|H|minutes as directed by your doctor. If you keep the enema inside||
7202|043|H|for less than 30 minutes, repeat the dose unless directed||
7202|044|H|otherwise.||
7202|045|H|   Use this medication regularly in order to get the most benefit||
7202|046|H|from it. Remember to use it at the same time each day.||
7202|047|H|   When this drug is given rectally for liver disease, an||
7202|048|H|improvement in your mental status may occur in as little as 2||
7202|049|H|hours, but if you are taking this medication by mouth, it may||
7202|050|H|take up to 24 to 48 hours. If you are using this medication for||
7202|051|H|constipation, it may take up to 48 hours to have a bowel||
7202|052|H|movement. Tell your doctor if your condition lasts or gets worse.||
7202|053|B|||
7202|054|S|SIDE EFFECTS:  Gas, bloating, burping, stomach rumbling/pain,||
7202|055|S|nausea, and cramps may occur. If any of these effects last or get||
7202|056|S|worse, tell your doctor or pharmacist promptly.||
7202|057|S|   Remember that this medication has been prescribed because your||
7202|058|S|doctor has judged that the benefit to you is greater than the||
7202|059|S|risk of side effects. Many people using this medication do not||
7202|060|S|have serious side effects.||
7202|061|S|   Tell your doctor right away if you have any serious side||
7202|062|S|effects, including: diarrhea, vomiting, muscle cramps/weakness,||
7202|063|S|irregular heartbeat, mental/mood changes, seizures.||
7202|064|S|   A very serious allergic reaction to this drug is rare.||
7202|065|S|However, get medical help right away if you notice any symptoms||
7202|066|S|of a serious allergic reaction, including: rash, itching/swelling||
7202|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7202|068|S|breathing.||
7202|069|S|   This is not a complete list of possible side effects. If you||
7202|070|S|notice other effects not listed above, contact your doctor or||
7202|071|S|pharmacist.||
7202|072|S|   In the US -||
7202|073|S|   Call your doctor for medical advice about side effects. You||
7202|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7202|075|S|www.fda.gov/medwatch.||
7202|076|S|   In Canada - Call your doctor for medical advice about side||
7202|077|S|effects. You may report side effects to Health Canada at||
7202|078|S|1-866-234-2345.||
7202|079|B|||
7202|080|P|PRECAUTIONS:  Before using lactulose, tell your doctor or||
7202|081|P|pharmacist if you are allergic to it; or if you have any other||
7202|082|P|allergies. This product may contain inactive ingredients, which||
7202|083|P|can cause allergic reactions or other problems. Talk to your||
7202|084|P|pharmacist for more details.||
7202|085|P|   Before using this medication, tell your doctor or pharmacist||
7202|086|P|your medical history, especially of: a low galactose diet (such||
7202|087|P|as a diet that includes few or no milk products), certain other||
7202|088|P|bowel problem (bowel obstruction), diabetes.||
7202|089|P|   Before having surgery, tell your doctor or dentist about all||
7202|090|P|the products you use (including prescription drugs,||
7202|091|P|nonprescription drugs, and herbal products).||
7202|092|P|   This medication contains different sugars. If you have||
7202|093|P|diabetes, this medication may affect your blood sugar. Check your||
7202|094|P|blood sugar regularly as directed and share the results with your||
7202|095|P|doctor. Your doctor may need to adjust your diabetes medication,||
7202|096|P|exercise program, or diet.||
7202|097|P|   During pregnancy, this medication should be used only when||
7202|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
7202|099|P|   It is unknown if this drug passes into breast milk. Consult||
7202|100|P|your doctor before breastfeeding.||
7202|101|B|||
7202|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7202|103|I|medications work or increase your risk for serious side effects.||
7202|104|I|This document does not contain all possible drug interactions.||
7202|105|I|Keep a list of all the products you use (including||
7202|106|I|prescription/nonprescription drugs and herbal products) and share||
7202|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
7202|108|I|the dosage of any medicines without your doctor's approval.||
7202|109|I|   Some products that may interact with this drug are: antacids||
7202|110|I|containing aluminum and/or magnesium, other laxatives (such as||
7202|111|I|cleansing enemas with soap suds).||
7202|112|B|||
7202|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7202|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7202|115|O|poison control center right away. US residents can call||
7202|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7202|117|O|Symptoms of overdose may include: severe stomach cramps,||
7202|118|O|diarrhea.||
7202|119|B|||
7202|120|N|NOTES:  If you are using this medication for liver disease, your||
7202|121|N|doctor may direct you to follow a low-protein diet. Follow any||
7202|122|N|dietary guidelines recommended by your doctor or dietician.||
7202|123|N|   Do not share this product with others.||
7202|124|N|   If you use this product for a long time, lab and/or medical||
7202|125|N|tests (such as blood mineral levels) should be done while you are||
7202|126|N|using this medication. Keep all medical and lab appointments.||
7202|127|N|Consult your doctor for more details.||
7202|128|B|||
7202|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7202|130|D|remember. If it is near the time of the next dose, skip the||
7202|131|D|missed dose. Take your next dose at the regular time. Do not||
7202|132|D|double the dose to catch up.||
7202|133|B|||
7202|134|R|STORAGE:  Different brands of this medication have different||
7202|135|R|storage needs. Check the product package for instructions on how||
7202|136|R|to store your brand, or ask your pharmacist. Keep all medications||
7202|137|R|away from children and pets.||
7202|138|R|   Do not flush medications down the toilet or pour them into a||
7202|139|R|drain unless instructed to do so. Properly discard this product||
7202|140|R|when it is expired or no longer needed. Consult your pharmacist||
7202|141|R|or local waste disposal company.||
7202|142|B|||
7202|143|A|Information last revised October 2024.||
7202|144|A|Copyright(c) 2025 First Databank, Inc.||
7202|145|B|||
7204|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7204|002|Z|does NOT have all possible information about this product. This||
7204|003|Z|information does not assure that this product is safe, effective,||
7204|004|Z|or appropriate for you. This information is not individual||
7204|005|Z|medical advice and does not substitute for the advice of your||
7204|006|Z|health care professional. Always ask your health care||
7204|007|Z|professional for complete information about this product and your||
7204|008|Z|specific health needs.||
7204|009|B|||
7204|010|T|DOXEPIN CREAM - TOPICAL||
7204|011|F|(dox-EH-pin)||
7204|012|B|||
7204|013|C|COMMON BRAND NAME(S): Zonalon||
7204|014|B|||
7204|015|U|USES:  This medication is used to relieve itching from certain||
7204|016|U|skin conditions (such as atopic dermatitis, eczema,||
7204|017|U|neurodermatitis). It should be used only for a short time (no||
7204|018|U|more than 8 days). Doxepin is a tricyclic antidepressant. It is||
7204|019|U|not known how this medication decreases itching. Some medication||
7204|020|U|is absorbed into the body when the cream is applied. This||
7204|021|U|medication may work by blocking a certain natural substance||
7204|022|U|(histamine) that your body makes during an allergic reaction. The||
7204|023|U|decrease in itching may be a result of drowsiness or some other||
7204|024|U|effect in the brain that causes you not to notice or be bothered||
7204|025|U|by the itching.||
7204|026|B|||
7204|027|H|HOW TO USE:  Before applying the medication, clean the affected||
7204|028|H|area with mild soap and water, rinse well, and pat dry. Gently||
7204|029|H|rub a small amount of the medication into the affected area in a||
7204|030|H|thin layer as directed by your doctor, usually 4 times a day.||
7204|031|H|Wait at least 3 to 4 hours between applications. How often the||
7204|032|H|medication is applied and for how long depends on your condition||
7204|033|H|and response to treatment. Usually, this medication is for||
7204|034|H|short-term use only (up to 8 days).||
7204|035|H|   Wash hands immediately after use unless the area being treated||
7204|036|H|includes the hands. This medication is for use on the skin only.||
7204|037|H|Avoid getting the product in your eyes, nose, ears, mouth, or||
7204|038|H|vaginal/anal area. If the medication gets in these areas, rinse||
7204|039|H|immediately with clean water.||
7204|040|H|   Do not cover the area with plastic or waterproof bandages.||
7204|041|H|Covering the treated area may increase the absorption of the||
7204|042|H|medication through the skin and increase the risk of side||
7204|043|H|effects.||
7204|044|H|   Do not use more of this product, use it more often, or keep||
7204|045|H|using it longer than prescribed by your doctor. Your condition||
7204|046|H|will not improve faster and the risk for side effects will||
7204|047|H|increase. Side effects may increase when you use the cream on a||
7204|048|H|larger area of skin (such as more than 10 percent of your body||
7204|049|H|surface). Tell your doctor if you have severe drowsiness while||
7204|050|H|using this product. It may be a sign that you are absorbing too||
7204|051|H|much of the medication. Your doctor may tell you to decrease how||
7204|052|H|often you apply the medication, the amount of medication used, or||
7204|053|H|how much skin to spread the medication over. Follow your doctor's||
7204|054|H|directions carefully.||
7204|055|H|   Tell your doctor if your condition does not get better or if||
7204|056|H|it gets worse.||
7204|057|B|||
7204|058|S|SIDE EFFECTS:  Burning/stinging at the application site,||
7204|059|S|drowsiness, dizziness, dry mouth, blurred vision, or changes in||
7204|060|S|taste may occur. If any of these effects last or get worse, tell||
7204|061|S|your doctor or pharmacist promptly.||
7204|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
7204|063|S|slowly when rising from a sitting or lying position.||
7204|064|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
7204|065|S|chips, chew (sugarless) gum, drink water, or use a saliva||
7204|066|S|substitute.||
7204|067|S|   Remember that this medication has been prescribed because your||
7204|068|S|doctor has judged that the benefit to you is greater than the||
7204|069|S|risk of side effects. Many people using this medication do not||
7204|070|S|have serious side effects.||
7204|071|S|   Tell your doctor right away if you have any serious side||
7204|072|S|effects, including: heartburn that doesn't go away, mental/mood||
7204|073|S|changes (such as agitation, confusion, depression), trouble||
7204|074|S|urinating, swelling of the hands/feet.||
7204|075|S|   Get medical help right away if you have any very serious side||
7204|076|S|effects, including: fast/irregular heartbeat, vision changes,||
7204|077|S|fainting, seizures.||
7204|078|S|   A very serious allergic reaction to this drug is rare.||
7204|079|S|However, get medical help right away if you notice any symptoms||
7204|080|S|of a serious allergic reaction, including: rash, itching/swelling||
7204|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7204|082|S|breathing.||
7204|083|S|   This is not a complete list of possible side effects. If you||
7204|084|S|notice other effects not listed above, contact your doctor or||
7204|085|S|pharmacist.||
7204|086|S|   In the US -||
7204|087|S|   Call your doctor for medical advice about side effects. You||
7204|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7204|089|S|www.fda.gov/medwatch.||
7204|090|S|   In Canada - Call your doctor for medical advice about side||
7204|091|S|effects. You may report side effects to Health Canada at||
7204|092|S|1-866-234-2345.||
7204|093|B|||
7204|094|P|PRECAUTIONS:  Before using doxepin, tell your doctor or||
7204|095|P|pharmacist if you are allergic to it, or to other tricyclic||
7204|096|P|antidepressants (such as amitriptyline); or if you have any other||
7204|097|P|allergies. This product may contain inactive ingredients, which||
7204|098|P|can cause allergic reactions or other problems. Talk to your||
7204|099|P|pharmacist for more details.||
7204|100|P|   Before using this medication, tell your doctor or pharmacist||
7204|101|P|your medical history, especially of: problems urinating (such as||
7204|102|P|due to enlarged prostate), breathing problems (such as||
7204|103|P|bronchitis, emphysema), glaucoma, heart problems (such as||
7204|104|P|irregular heartbeat), kidney problems, liver problems, overactive||
7204|105|P|thyroid (hyperthyroidism), personal or family history of||
7204|106|P|mental/mood conditions (such as bipolar disorder, psychosis,||
7204|107|P|suicide), seizures, conditions that may increase your risk of||
7204|108|P|seizures (such as other brain disease, alcohol withdrawal).||
7204|109|P|   Doxepin may cause a condition that affects the heart rhythm||
7204|110|P|(QT prolongation). QT prolongation can rarely cause serious||
7204|111|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
7204|112|P|as severe dizziness, fainting) that need medical attention right||
7204|113|P|away.||
7204|114|P|   The risk of QT prolongation may be increased if you have||
7204|115|P|certain medical conditions or are taking other drugs that may||
7204|116|P|cause QT prolongation. Before using doxepin, tell your doctor or||
7204|117|P|pharmacist of all the drugs you take and if you have any of the||
7204|118|P|following conditions: certain heart problems (heart failure, slow||
7204|119|P|heartbeat, QT prolongation in the EKG), family history of certain||
7204|120|P|heart problems (QT prolongation in the EKG, sudden cardiac||
7204|121|P|death).||
7204|122|P|   Low levels of potassium or magnesium in the blood may also||
7204|123|P|increase your risk of QT prolongation. This risk may increase if||
7204|124|P|you use certain drugs (such as diuretics/"water pills") or if you||
7204|125|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7204|126|P|Talk to your doctor about using doxepin safely.||
7204|127|P|   This drug may make you dizzy or drowsy or blur your vision.||
7204|128|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7204|129|P|drowsy. Do not drive, use machinery, or do anything that needs||
7204|130|P|alertness or clear vision until you can do it safely. Limit||
7204|131|P|alcoholic beverages. Talk to your doctor if you are using||
7204|132|P|marijuana (cannabis).||
7204|133|P|   Before having surgery, tell your doctor or dentist about all||
7204|134|P|the products you use (including prescription drugs,||
7204|135|P|nonprescription drugs, and herbal products).||
7204|136|P|   If you have diabetes, this drug may affect your blood sugar.||
7204|137|P|Check your blood sugar regularly as directed and share the||
7204|138|P|results with your doctor. Tell your doctor right away if you have||
7204|139|P|symptoms of high blood sugar such as increased thirst/urination||
7204|140|P|or signs of low blood sugar such as sudden sweating, shaking,||
7204|141|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
7204|142|P|hands/feet. Your doctor may need to adjust your diabetes||
7204|143|P|medication, exercise program, or diet.||
7204|144|P|   Older adults may be more sensitive to the side effects of this||
7204|145|P|drug, especially dizziness, drowsiness, confusion, difficulty||
7204|146|P|urinating, and QT prolongation (see above).||
7204|147|P|   During pregnancy, this medication should be used only when||
7204|148|P|clearly needed. Discuss the risks and benefits with your doctor.||
7204|149|P|   This medication passes into breast milk and could have||
7204|150|P|undesirable effects on a nursing infant. Breastfeeding is not||
7204|151|P|recommended while using this medication. Consult your doctor||
7204|152|P|before breastfeeding.||
7204|153|B|||
7204|154|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7204|155|I|medications work or increase your risk for serious side effects.||
7204|156|I|This document does not contain all possible drug interactions.||
7204|157|I|Keep a list of all the products you use (such as||
7204|158|I|prescription/nonprescription drugs and herbal products) and share||
7204|159|I|it with your doctor and pharmacist. Do not start, stop, or change||
7204|160|I|the dosage of any medicines without your doctor's approval.||
7204|161|I|   Some products that may interact with this drug are: certain||
7204|162|I|drugs for high blood pressure (such as clonidine, guanadrel,||
7204|163|I|guanethidine), thyroid medication.||
7204|164|I|   Taking MAO inhibitors with this medication may cause a serious||
7204|165|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
7204|166|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
7204|167|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
7204|168|I|selegiline, tranylcypromine) during treatment with this||
7204|169|I|medication. Most MAO inhibitors should also not be taken for two||
7204|170|I|weeks before and after treatment with this medication. Ask your||
7204|171|I|doctor when to start or stop taking this medication.||
7204|172|I|   Other medications can affect the removal of doxepin from your||
7204|173|I|body, which may affect how doxepin works. Examples include||
7204|174|I|cimetidine, St. John's Wort, drugs to treat irregular heart rate||
7204|175|I|(such as propafenone, flecainide), antidepressants (such as SSRIs||
7204|176|I|including paroxetine, fluoxetine, fluvoxamine), drugs used to||
7204|177|I|treat seizures (such as phenobarbital, phenytoin), among others.||
7204|178|I|   Many drugs besides doxepin may affect the heart rhythm (QT||
7204|179|I|prolongation), including amiodarone, dofetilide, quinidine,||
7204|180|I|procainamide, sotalol, macrolide antibiotics (such as||
7204|181|I|erythromycin), among others. Before using doxepin, report all||
7204|182|I|medications you are currently using to your doctor or pharmacist.||
7204|183|I|   Tell your doctor or pharmacist if you are taking other||
7204|184|I|products that cause drowsiness such as opioid pain or cough||
7204|185|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7204|186|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
7204|187|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7204|188|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7204|189|I|diphenhydramine).||
7204|190|I|   Check the labels on all your medicines (such as allergy or||
7204|191|I|cough-and-cold products) because they may contain ingredients||
7204|192|I|that cause drowsiness. Ask your pharmacist about using those||
7204|193|I|products safely.||
7204|194|B|||
7204|195|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7204|196|O|has overdosed and has serious symptoms such as passing out or||
7204|197|O|trouble breathing, call 911. Otherwise, call a poison control||
7204|198|O|center right away. US residents can call 1-800-222-1222. Canada||
7204|199|O|residents can call 1-844-764-7669. Symptoms of overdose or||
7204|200|O|swallowing may include: confusion, hallucinations, big/wide||
7204|201|O|pupils, fast/irregular heartbeat, severe dizziness, fainting,||
7204|202|O|seizures, loss of consciousness.||
7204|203|B|||
7204|204|N|NOTES:  Do not share this medication with others.||
7204|205|N|   Use this medication only for the condition for which it was||
7204|206|N|prescribed. Tell all your doctors you use this medication.||
7204|207|B|||
7204|208|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
7204|209|D|remember. If it is near the time of the next dose, skip the||
7204|210|D|missed dose. Use your next dose at the regular time. Do not apply||
7204|211|D|more to catch up.||
7204|212|B|||
7204|213|R|STORAGE:  Store at room temperature. Keep all medications away||
7204|214|R|from children and pets.||
7204|215|R|   Do not flush medications down the toilet or pour them into a||
7204|216|R|drain unless instructed to do so. Properly discard this product||
7204|217|R|when it is expired or no longer needed. Consult your pharmacist||
7204|218|R|or local waste disposal company.||
7204|219|B|||
7204|220|A|Information last revised May 2025.||
7204|221|A|Copyright(c) 2025 First Databank, Inc.||
7204|222|B|||
7205|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7205|002|Z|does NOT have all possible information about this product. This||
7205|003|Z|information does not assure that this product is safe, effective,||
7205|004|Z|or appropriate for you. This information is not individual||
7205|005|Z|medical advice and does not substitute for the advice of your||
7205|006|Z|health care professional. Always ask your health care||
7205|007|Z|professional for complete information about this product and your||
7205|008|Z|specific health needs.||
7205|009|B|||
7205|010|T|ALPROSTADIL - INTRACAVERNOSAL||
7205|011|F|(al-PROS-ta-dil)||
7205|012|B|||
7205|013|C|COMMON BRAND NAME(S): Caverject||
7205|014|B|||
7205|015|U|USES:  This medication is used to treat male sexual function||
7205|016|U|problems (erectile dysfunction). It works by helping the blood||
7205|017|U|flow into the penis to achieve and maintain an erection.||
7205|018|U|   This medication is not for use in women or children.||
7205|019|U|   This medication is not recommended for use in men with penile||
7205|020|U|implants.||
7205|021|U|   This medication does not protect against sexually transmitted||
7205|022|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
7205|023|U|an effective barrier method (latex or polyurethane condom/dental||
7205|024|U|dams) during sexual activity will help to decrease your risk of||
7205|025|U|infection.||
7205|026|B|||
7205|027|H|HOW TO USE:  Read the Patient Information Leaflet and||
7205|028|H|Instructions for Use if available from your pharmacist before you||
7205|029|H|start using this medication and each time you get a refill. Ask||
7205|030|H|your health care professional how to prepare and use this||
7205|031|H|medication. If you have any questions, ask your doctor or||
7205|032|H|pharmacist.||
7205|033|H|   Inject this medication into the penis as directed by your||
7205|034|H|doctor. The dosage is based on your medical condition and||
7205|035|H|response to treatment. This medication should usually work within||
7205|036|H|5 to 20 minutes to produce an erection that lasts for about 1||
7205|037|H|hour. This medication should not be used more than 3 times a||
7205|038|H|week, with at least 1 day between each dose.||
7205|039|H|   Before using, check this product for particles or||
7205|040|H|discoloration. If either is present, do not use the liquid.||
7205|041|H|Before injecting each dose, clean the injection site with rubbing||
7205|042|H|alcohol. Change the injection site each time to lessen injury||
7205|043|H|under the skin. Choose an injection site on the other side of the||
7205|044|H|penis from the site of the last dose, using a different area each||
7205|045|H|time. After injection, apply pressure to the injection site with||
7205|046|H|an alcohol swab for about 5 minutes to avoid bruising. Do not use||
7205|047|H|a bent needle to inject this medication. If the needle is bent,||
7205|048|H|replace it with a new needle. If the needle breaks during||
7205|049|H|injection, contact your doctor right away. Learn how to store and||
7205|050|H|discard medical supplies safely.||
7205|051|H|   Tell your doctor if your condition lasts or gets worse (for||
7205|052|H|example, if the drug does not produce an erection or it becomes||
7205|053|H|more difficult to get an erection).||
7205|054|B|||
7205|055|S|SIDE EFFECTS:  Mild/moderate pain, irritation, or slight bleeding||
7205|056|S|at the injection site may occur. If any of these effects last or||
7205|057|S|get worse, tell your doctor or pharmacist promptly.||
7205|058|S|   Remember that this medication has been prescribed because your||
7205|059|S|doctor has judged that the benefit to you is greater than the||
7205|060|S|risk of side effects. Many people using this medication do not||
7205|061|S|have serious side effects.||
7205|062|S|   Tell your doctor right away if you have any serious side||
7205|063|S|effects, including: redness/tenderness/swelling of the penis,||
7205|064|S|lumps/unusual curving of the penis.||
7205|065|S|   Rarely, males may have a painful or prolonged erection lasting||
7205|066|S|4 or more hours. If this occurs, stop using this drug and get||
7205|067|S|medical help right away, or permanent problems could occur.||
7205|068|S|   A very serious allergic reaction to this drug is rare.||
7205|069|S|However, get medical help right away if you notice any symptoms||
7205|070|S|of a serious allergic reaction, including: rash, itching/swelling||
7205|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7205|072|S|breathing.||
7205|073|S|   This is not a complete list of possible side effects. If you||
7205|074|S|notice other effects not listed above, contact your doctor or||
7205|075|S|pharmacist.||
7205|076|S|   In the US -||
7205|077|S|   Call your doctor for medical advice about side effects. You||
7205|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7205|079|S|www.fda.gov/medwatch.||
7205|080|S|   In Canada - Call your doctor for medical advice about side||
7205|081|S|effects. You may report side effects to Health Canada at||
7205|082|S|1-866-234-2345.||
7205|083|B|||
7205|084|P|PRECAUTIONS:  Before using alprostadil, tell your doctor or||
7205|085|P|pharmacist if you are allergic to it; or if you have any other||
7205|086|P|allergies. This product may contain inactive ingredients, which||
7205|087|P|can cause allergic reactions or other problems. Talk to your||
7205|088|P|pharmacist for more details.||
7205|089|P|   Before using this medication, tell your doctor or pharmacist||
7205|090|P|your medical history, especially of: penis conditions (such as||
7205|091|P|angulation, fibrosis/scarring, Peyronie's disease), blood system||
7205|092|P|cancers (such as leukemia, multiple myeloma), sickle cell anemia.||
7205|093|P|   Before having surgery, tell your doctor or dentist about all||
7205|094|P|the products you use (including prescription drugs,||
7205|095|P|nonprescription drugs, and herbal products).||
7205|096|B|||
7205|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7205|098|I|medications work or increase your risk for serious side effects.||
7205|099|I|This document does not contain all possible drug interactions.||
7205|100|I|Keep a list of all the products you use (including||
7205|101|I|prescription/nonprescription drugs and herbal products) and share||
7205|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
7205|103|I|the dosage of any medicines without your doctor's approval.||
7205|104|I|   Some products that may interact with this drug include: "blood||
7205|105|I|thinners" (such as warfarin, heparin).||
7205|106|B|||
7205|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7205|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7205|109|O|poison control center right away. US residents can call||
7205|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7205|111|B|||
7205|112|N|NOTES:  Do not share this medication with others.||
7205|113|B|||
7205|114|D|MISSED DOSE:  Not applicable.||
7205|115|B|||
7205|116|R|STORAGE:  Different brands of this medication have different||
7205|117|R|storage needs. Check the product package for instructions on how||
7205|118|R|to store your brand, or ask your pharmacist. Keep all medications||
7205|119|R|away from children and pets.||
7205|120|R|   Do not flush medications down the toilet or pour them into a||
7205|121|R|drain unless instructed to do so. Properly discard this product||
7205|122|R|when it is expired or no longer needed. Consult your pharmacist||
7205|123|R|or local waste disposal company.||
7205|124|B|||
7205|125|A|Information last revised October 2025.||
7205|126|A|Copyright(c) 2025 First Databank, Inc.||
7205|127|B|||
7206|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7206|002|Z|does NOT have all possible information about this product. This||
7206|003|Z|information does not assure that this product is safe, effective,||
7206|004|Z|or appropriate for you. This information is not individual||
7206|005|Z|medical advice and does not substitute for the advice of your||
7206|006|Z|health care professional. Always ask your health care||
7206|007|Z|professional for complete information about this product and your||
7206|008|Z|specific health needs.||
7206|009|B|||
7206|010|T|TERBINAFINE CREAM - TOPICAL||
7206|011|F|(ter-BIN-uh-feen)||
7206|012|B|||
7206|013|C|COMMON BRAND NAME(S): Lamisil||
7206|014|B|||
7206|015|U|USES:  This medication is used to treat a variety of fungal skin||
7206|016|U|infections such as ringworm, athlete's foot, and jock itch. This||
7206|017|U|medication is also used to treat a skin condition known as||
7206|018|U|pityriasis (tinea versicolor), a fungal infection that causes a||
7206|019|U|lightening or darkening of the skin of the neck, chest, arms, or||
7206|020|U|legs. Terbinafine is an antifungal that works by preventing the||
7206|021|U|growth of fungus.||
7206|022|B|||
7206|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
7206|024|H|thoroughly dry the area to be treated. Apply a thin layer of the||
7206|025|H|medication on and around the affected area, usually once or twice||
7206|026|H|daily as directed on the product package. If you have any||
7206|027|H|questions, ask your doctor or pharmacist. Wash your hands after||
7206|028|H|using unless the area being treated includes the hands. Do not||
7206|029|H|wrap, cover, or bandage the area unless directed to do so by your||
7206|030|H|doctor.||
7206|031|H|   Do not apply the medication in the eyes, nose, or mouth, or||
7206|032|H|inside the vagina. If you do get the medication in those areas,||
7206|033|H|flush with plenty of water.||
7206|034|H|   Do not apply this medication on the scalp or nails unless||
7206|035|H|otherwise directed by your doctor.||
7206|036|H|   The dosage and length of treatment depends on the type of||
7206|037|H|infection being treated.||
7206|038|H|   Do not apply more often or use longer than directed. This may||
7206|039|H|increase the risk of side effects.||
7206|040|H|   Use this medication regularly to get the most benefit from it.||
7206|041|H|To help you remember, use it at the same time(s) each day.||
7206|042|H|   Continue to use this medication until the full treatment||
7206|043|H|period is finished, even if symptoms disappear after a few days.||
7206|044|H|Stopping the medication too early may result in a return of the||
7206|045|H|infection.||
7206|046|H|   Your condition may continue to improve after the full||
7206|047|H|treatment is finished. It may take several weeks after treatment||
7206|048|H|for the infection to completely heal. Tell your doctor if your||
7206|049|H|condition gets worse or if it does not get better within 2 weeks||
7206|050|H|for jock itch and ringworm and within 4 weeks for athlete's foot.||
7206|051|B|||
7206|052|S|SIDE EFFECTS:  Burning, irritation, or itching at the application||
7206|053|S|site may occur. If any of these effects last or get worse, tell||
7206|054|S|your doctor or pharmacist promptly.||
7206|055|S|   If your doctor has directed you to use this medication,||
7206|056|S|remember that your doctor has judged that the benefit to you is||
7206|057|S|greater than the risk of side effects. Many people using this||
7206|058|S|medication do not have serious side effects.||
7206|059|S|   Tell your doctor right away if you have any serious side||
7206|060|S|effects, including: blistering/swelling/oozing at the application||
7206|061|S|site.||
7206|062|S|   A very serious allergic reaction to this drug is rare.||
7206|063|S|However, get medical help right away if you notice any symptoms||
7206|064|S|of a serious allergic reaction, including: rash, itching/swelling||
7206|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7206|066|S|breathing.||
7206|067|S|   This is not a complete list of possible side effects. If you||
7206|068|S|notice other effects not listed above, contact your doctor or||
7206|069|S|pharmacist.||
7206|070|S|   In the US -||
7206|071|S|   Call your doctor for medical advice about side effects. You||
7206|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7206|073|S|www.fda.gov/medwatch.||
7206|074|S|   In Canada - Call your doctor for medical advice about side||
7206|075|S|effects. You may report side effects to Health Canada at||
7206|076|S|1-866-234-2345.||
7206|077|B|||
7206|078|P|PRECAUTIONS:  Before using terbinafine, tell your doctor or||
7206|079|P|pharmacist if you are allergic to it; or to other allylamine||
7206|080|P|antifungals (such as naftifine); or if you have any other||
7206|081|P|allergies. This product may contain inactive ingredients, which||
7206|082|P|can cause allergic reactions or other problems. Talk to your||
7206|083|P|pharmacist for more details.||
7206|084|P|   If you have any health problems, consult your doctor or||
7206|085|P|pharmacist before using this product.||
7206|086|P|   During pregnancy, this medication should be used only when||
7206|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
7206|088|P|   It is unknown if this drug passes into breast milk when||
7206|089|P|applied to the skin. Other forms of this medication pass into||
7206|090|P|breast milk when taken by mouth. Consult your doctor before||
7206|091|P|breastfeeding.||
7206|092|B|||
7206|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7206|094|I|medications work or increase your risk for serious side effects.||
7206|095|I|This document does not contain all possible drug interactions.||
7206|096|I|Keep a list of all the products you use (including||
7206|097|I|prescription/nonprescription drugs and herbal products) and share||
7206|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
7206|099|I|the dosage of any medicines without your doctor's approval.||
7206|100|B|||
7206|101|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7206|102|O|has overdosed and has serious symptoms such as passing out or||
7206|103|O|trouble breathing, call 911. Otherwise, call a poison control||
7206|104|O|center right away. US residents can call 1-800-222-1222. Canada||
7206|105|O|residents can call 1-844-764-7669.||
7206|106|B|||
7206|107|N|NOTES:  Keep all medical and lab appointments.||
7206|108|N|   If you are treating athlete's foot, make sure to wear||
7206|109|N|well-fitting, ventilated shoes. Also, change shoes and socks at||
7206|110|N|least once daily.||
7206|111|N|   When this medication is used to treat pityriasis, your normal||
7206|112|N|skin color may not return right away. It may take several months||
7206|113|N|after treatment is completed for your natural skin color to||
7206|114|N|return.||
7206|115|B|||
7206|116|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7206|117|D|If it is near the time of the next dose, skip the missed dose.||
7206|118|D|Use your next dose at the regular time. Do not double the dose to||
7206|119|D|catch up.||
7206|120|B|||
7206|121|R|STORAGE:  Store at room temperature. Do not refrigerate. Keep all||
7206|122|R|medications away from children and pets.||
7206|123|R|   Do not flush medications down the toilet or pour them into a||
7206|124|R|drain unless instructed to do so. Properly discard this product||
7206|125|R|when it is expired or no longer needed. Consult your pharmacist||
7206|126|R|or local waste disposal company.||
7206|127|B|||
7206|128|A|Information last revised November 2024.||
7206|129|A|Copyright(c) 2025 First Databank, Inc.||
7206|130|B|||
7216|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7216|002|Z|does NOT have all possible information about this product. This||
7216|003|Z|information does not assure that this product is safe, effective,||
7216|004|Z|or appropriate for you. This information is not individual||
7216|005|Z|medical advice and does not substitute for the advice of your||
7216|006|Z|health care professional. Always ask your health care||
7216|007|Z|professional for complete information about this product and your||
7216|008|Z|specific health needs.||
7216|009|B|||
7216|010|T|INTERFERON BETA-1A - SUBCUTANEOUS INJECTION||
7216|011|F|(IN-ter-FEER-on BAY-ta-wun-ay)||
7216|012|B|||
7216|013|C|COMMON BRAND NAME(S): Rebif||
7216|014|B|||
7216|015|U|USES:  This medication is used to treat multiple sclerosis (MS).||
7216|016|U|Interferon is not a cure for MS, but it may help to slow disease||
7216|017|U|worsening and decrease flare-ups of symptoms (such as balance||
7216|018|U|problems, numbness, or weakness).||
7216|019|B|||
7216|020|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
7216|021|H|provided by your pharmacist before you start using this||
7216|022|H|medication and each time you get a refill. Ask your health care||
7216|023|H|professional how to prepare and use this medication. If you have||
7216|024|H|any questions, ask your doctor or pharmacist.||
7216|025|H|   Inject this medication under the skin as directed by your||
7216|026|H|doctor, usually 3 times a week, at least 48 hours apart (such as||
7216|027|H|Monday, Wednesday, and Friday). The injection is given in the||
7216|028|H|thigh, abdomen, buttock, or the back of the upper arm. It is best||
7216|029|H|to use this medication near bedtime to reduce side effects. The||
7216|030|H|dosage is based on your medical condition and response to||
7216|031|H|treatment. To reduce your risk of side effects, your doctor may||
7216|032|H|direct you to start this medication at a low dose and gradually||
7216|033|H|increase your dose. Follow your doctor's instructions carefully.||
7216|034|H|   For a more comfortable injection, take the medication out of||
7216|035|H|the refrigerator at least 30 minutes before you inject it to||
7216|036|H|allow it to reach room temperature. Do not warm up this||
7216|037|H|medication any other way (for example, do not heat it in the||
7216|038|H|microwave or place it in hot water). Before using, check this||
7216|039|H|product for particles or discoloration. If either is present, do||
7216|040|H|not use the liquid. Before injecting each dose, clean the skin||
7216|041|H|you are going to inject into (the injection site) with rubbing||
7216|042|H|alcohol. Change the injection site each time to lessen injury||
7216|043|H|under the skin. Do not inject into skin that is red, sore,||
7216|044|H|scarred, or infected. Tell your doctor of any skin reactions that||
7216|045|H|do not go away after a few days. Learn how to store and discard||
7216|046|H|medical supplies safely.||
7216|047|H|   Use this medication regularly to get the most benefit from it.||
7216|048|H|To help you remember, use it at the same time for each scheduled||
7216|049|H|dose.||
7216|050|H|   Tell your doctor if your condition gets worse.||
7216|051|B|||
7216|052|S|SIDE EFFECTS:  Pain, redness, or swelling at the injection site||
7216|053|S|may occur. If any of these effects last or get worse, tell your||
7216|054|S|doctor promptly.||
7216|055|S|   Most people have flu-like symptoms such as headache,||
7216|056|S|tiredness, fever, chills, and muscle aches when they first start||
7216|057|S|this medication. These symptoms usually last about 1 day after||
7216|058|S|the injection and improve or go away after a few months of||
7216|059|S|continued use. You can lessen these side effects by injecting||
7216|060|S|this medicine at bedtime and by using fever reducers/pain||
7216|061|S|relievers such as acetaminophen or ibuprofen before each dose.||
7216|062|S|Ask your doctor or pharmacist for more information.||
7216|063|S|   Remember that this medication has been prescribed because your||
7216|064|S|doctor has judged that the benefit to you is greater than the||
7216|065|S|risk of side effects. Many people using this medication do not||
7216|066|S|have serious side effects.||
7216|067|S|   Tell your doctor right away if you have any serious side||
7216|068|S|effects, including: mental/mood changes (such as new or worsening||
7216|069|S|depression, thoughts of suicide, psychosis), feeling too hot or||
7216|070|S|cold (more than others around you), blue fingers/toes, easy||
7216|071|S|bleeding/bruising, pus or change in skin color at the injection||
7216|072|S|site, joint pain/swelling, signs of kidney problems (such as a||
7216|073|S|change in the amount of urine), signs of liver problems (such as||
7216|074|S|nausea/vomiting that doesn't stop, loss of appetite,||
7216|075|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), new or||
7216|076|S|worsening symptoms of heart failure (such as shortness of breath,||
7216|077|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
7216|078|S|gain).||
7216|079|S|   Get medical help right away if you have any very serious side||
7216|080|S|effects, including: seizures.||
7216|081|S|   This medication may lower your ability to fight infections.||
7216|082|S|This may make you more likely to get a serious (rarely fatal)||
7216|083|S|infection or make any infection you have worse. Tell your doctor||
7216|084|S|right away if you have any signs of infections (such as sore||
7216|085|S|throat that doesn't go away, fever, chills).||
7216|086|S|   A very serious allergic reaction to this drug is rare.||
7216|087|S|However, get medical help right away if you notice any symptoms||
7216|088|S|of a serious allergic reaction, including: rash, itching/swelling||
7216|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7216|090|S|breathing.||
7216|091|S|   This is not a complete list of possible side effects. If you||
7216|092|S|notice other effects not listed above, contact your doctor or||
7216|093|S|pharmacist.||
7216|094|S|   In the US -||
7216|095|S|   Call your doctor for medical advice about side effects. You||
7216|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7216|097|S|www.fda.gov/medwatch.||
7216|098|S|   In Canada - Call your doctor for medical advice about side||
7216|099|S|effects. You may report side effects to Health Canada at||
7216|100|S|1-866-234-2345.||
7216|101|B|||
7216|102|P|PRECAUTIONS:  Before using interferon, tell your doctor or||
7216|103|P|pharmacist if you are allergic to it; or to products containing||
7216|104|P|human albumin; or if you have any other allergies. This product||
7216|105|P|may contain inactive ingredients, which can cause allergic||
7216|106|P|reactions or other problems. Talk to your pharmacist for more||
7216|107|P|details.||
7216|108|P|   Some brands of this medication contain albumin made from human||
7216|109|P|blood. Even though the blood is carefully tested, and this||
7216|110|P|medication goes through a special manufacturing process, there is||
7216|111|P|an extremely small chance that you may get infections from the||
7216|112|P|medication (for example viruses such as hepatitis). Consult your||
7216|113|P|doctor or pharmacist for more information.||
7216|114|P|   Before using this medication, tell your doctor or pharmacist||
7216|115|P|your medical history, especially of: bleeding/blood problems,||
7216|116|P|heart problems (such as heart failure, angina, fast/irregular||
7216|117|P|heartbeat), liver disease, mental/mood disorders (such as||
7216|118|P|depression, psychosis, suicidal thoughts), seizure disorder,||
7216|119|P|thyroid disease.||
7216|120|P|   Interferon can make you more likely to get infections or may||
7216|121|P|make current infections worse. Stay away from anyone who has an||
7216|122|P|infection that may easily spread (such as chickenpox, COVID-19,||
7216|123|P|measles, flu). Talk to your doctor if you have been exposed to an||
7216|124|P|infection or for more details.||
7216|125|P|   Tell your health care professional that you are using||
7216|126|P|interferon before having any immunizations/vaccinations. Avoid||
7216|127|P|contact with people who have recently received live vaccines||
7216|128|P|(such as flu vaccine inhaled through the nose).||
7216|129|P|   Before having surgery, tell your doctor or dentist about all||
7216|130|P|the products you use (including prescription drugs,||
7216|131|P|nonprescription drugs, and herbal products).||
7216|132|P|   During pregnancy, this medication should be used only when||
7216|133|P|clearly needed. Discuss the risks and benefits with your doctor.||
7216|134|P|   This medication passes into breast milk in small amounts, but||
7216|135|P|is unlikely to harm a nursing infant. Consult your doctor before||
7216|136|P|breastfeeding.||
7216|137|B|||
7216|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7216|139|I|medications work or increase your risk for serious side effects.||
7216|140|I|This document does not contain all possible drug interactions.||
7216|141|I|Keep a list of all the products you use (including||
7216|142|I|prescription/nonprescription drugs and herbal products) and share||
7216|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
7216|144|I|the dosage of any medicines without your doctor's approval.||
7216|145|B|||
7216|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7216|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7216|148|O|poison control center right away. US residents can call||
7216|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7216|150|B|||
7216|151|N|NOTES:  Do not share this medication with others.||
7216|152|N|   Lab and/or medical tests (such as complete blood count,||
7216|153|N|liver/thyroid function) should be done while you are using this||
7216|154|N|medication. Keep all medical and lab appointments.||
7216|155|B|||
7216|156|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember,||
7216|157|D|then skip the next day. Do not use this medication 2 days in a||
7216|158|D|row. Do not double the dose to catch up. Follow your usual||
7216|159|D|schedule the next week.||
7216|160|B|||
7216|161|R|STORAGE:  Store in the refrigerator away from light. Do not||
7216|162|R|freeze. This medication may also be stored at room temperature if||
7216|163|R|needed. If the medication is stored at room temperature, discard||
7216|164|R|after 30 days. Keep all medications away from children and pets.||
7216|165|R|   Do not flush medications down the toilet or pour them into a||
7216|166|R|drain unless instructed to do so. Properly discard this product||
7216|167|R|when it is expired or no longer needed. Consult your pharmacist||
7216|168|R|or local waste disposal company.||
7216|169|B|||
7216|170|A|Information last revised May 2025.||
7216|171|A|Copyright(c) 2025 First Databank, Inc.||
7216|172|B|||
7217|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7217|002|Z|does NOT have all possible information about this product. This||
7217|003|Z|information does not assure that this product is safe, effective,||
7217|004|Z|or appropriate for you. This information is not individual||
7217|005|Z|medical advice and does not substitute for the advice of your||
7217|006|Z|health care professional. Always ask your health care||
7217|007|Z|professional for complete information about this product and your||
7217|008|Z|specific health needs.||
7217|009|B|||
7217|010|T|LAMOTRIGINE - ORAL||
7217|011|F|(lam-OH-try-jeen)||
7217|012|B|||
7217|013|C|COMMON BRAND NAME(S): Lamictal, Subvenite||
7217|014|B|||
7217|015|W|WARNING:  Rarely, serious (sometimes fatal) skin rashes have||
7217|016|W|occurred while taking this medication. These rashes are more||
7217|017|W|common in children than in adults. Rashes may be more likely if||
7217|018|W|you start at too high a dose, if you increase your dose too||
7217|019|W|quickly, or if you take this medication with certain other||
7217|020|W|anti-seizure medications (valproic acid, divalproex). These||
7217|021|W|rashes may occur anytime during use, but most serious rashes have||
7217|022|W|occurred within 2 to 8 weeks of starting lamotrigine.||
7217|023|W|   Get medical help right away if you develop any type of skin||
7217|024|W|rash, or if you have other signs of a serious allergic reaction||
7217|025|W|such as hives, fever, swollen lymph nodes, severe dizziness,||
7217|026|W|painful sores in the mouth or around the eyes, swelling of the||
7217|027|W|face/tongue/throat, trouble breathing, or liver problems||
7217|028|W|(symptoms include stomach/abdominal pain, nausea/vomiting that||
7217|029|W|continues, dark urine, yellowing eyes/skin). Your doctor will||
7217|030|W|tell you if you should stop taking lamotrigine. Even after you||
7217|031|W|stop taking this, it is still possible for a rash to become||
7217|032|W|life-threatening or cause permanent scars or other problems.||
7217|033|B|||
7217|034|U|USES:  Lamotrigine is used alone or with other medications to||
7217|035|U|prevent and control seizures. It may also be used to help prevent||
7217|036|U|the extreme mood swings of bipolar disorder in adults.||
7217|037|U|   Lamotrigine is known as an anticonvulsant or antiepileptic||
7217|038|U|drug. It is thought to work by restoring the balance of certain||
7217|039|U|natural substances in the brain.||
7217|040|U|   This drug is not approved for use in children younger than 2||
7217|041|U|years due to an increased risk of side effects (such as||
7217|042|U|infections).||
7217|043|B|||
7217|044|V|OTHER USES:  This section contains uses of this drug that are not||
7217|045|V|listed in the approved professional labeling for the drug but||
7217|046|V|that may be prescribed by your health care professional. Use this||
7217|047|V|drug for a condition that is listed in this section only if it||
7217|048|V|has been so prescribed by your health care professional.||
7217|049|V|   This medication may also be used for nerve pain.||
7217|050|B|||
7217|051|H|HOW TO USE:  Read the Medication Guide and, if available, the||
7217|052|H|Patient Information Leaflet provided by your pharmacist before||
7217|053|H|you start taking lamotrigine and each time you get a refill. If||
7217|054|H|you have any questions, ask your doctor or pharmacist.||
7217|055|H|   Take this medication by mouth with or without food as directed||
7217|056|H|by your doctor. If you are using the tablet form of this||
7217|057|H|medication, swallow the tablets whole since chewing them may||
7217|058|H|leave a bitter taste.||
7217|059|H|   If you are using the liquid form of this medication, shake the||
7217|060|H|bottle well before each dose. Carefully measure the dose using a||
7217|061|H|special measuring device/spoon. Do not use a household spoon||
7217|062|H|because you may not get the correct dose.||
7217|063|H|   The dosage is based on your medical condition, response to||
7217|064|H|treatment, and other medications you may be taking. Children's||
7217|065|H|dosage is also based on weight. Be sure to tell your doctor and||
7217|066|H|pharmacist about all the products you use (including prescription||
7217|067|H|drugs, nonprescription drugs, and herbal products).||
7217|068|H|   It is very important to follow your doctor's dosing||
7217|069|H|instructions exactly. The dose must be increased slowly. It may||
7217|070|H|take several weeks or months to reach the best dose for you and||
7217|071|H|to get the full benefit from this medication. Take this||
7217|072|H|medication regularly in order to get the most benefit from it. To||
7217|073|H|help you remember, take it at the same time(s) each day.||
7217|074|H|   Do not stop taking this medication without consulting your||
7217|075|H|doctor. Some conditions may become worse when the drug is||
7217|076|H|suddenly stopped. Your dose may need to be gradually decreased.||
7217|077|H|Also, if you have stopped taking this medication, do not restart||
7217|078|H|lamotrigine without consulting your doctor.||
7217|079|H|   Tell your doctor if your condition does not get better or if||
7217|080|H|it gets worse.||
7217|081|B|||
7217|082|S|SIDE EFFECTS:  See also Warning section.||
7217|083|S|   Dizziness, drowsiness, headache, vomiting, or upset stomach||
7217|084|S|may occur. If any of these effects last or get worse, tell your||
7217|085|S|doctor or pharmacist promptly.||
7217|086|S|   Remember that this medication has been prescribed because your||
7217|087|S|doctor has judged that the benefit to you is greater than the||
7217|088|S|risk of side effects. Many people using this medication do not||
7217|089|S|have serious side effects.||
7217|090|S|   A small number of people who take anticonvulsants for any||
7217|091|S|condition (such as seizures, bipolar disorder, pain) may||
7217|092|S|experience depression, suicidal thoughts/attempts, or other||
7217|093|S|mental/mood problems. Tell your doctor right away if you or your||
7217|094|S|family/caregiver notice any unusual/sudden changes in your mood,||
7217|095|S|thoughts, or behavior including signs of depression, suicidal||
7217|096|S|thoughts/attempts, thoughts about harming yourself.||
7217|097|S|   Get medical help right away if you have any very serious side||
7217|098|S|effects, including: fainting, fast/slow/irregular/pounding||
7217|099|S|heartbeat, easy or unusual bruising/bleeding, stiff neck, vision||
7217|100|S|problems, loss of coordination, muscle pain/tenderness/weakness,||
7217|101|S|signs of kidney problems (such as change in the amount of urine).||
7217|102|S|   This is not a complete list of possible side effects. If you||
7217|103|S|notice other effects not listed above, contact your doctor or||
7217|104|S|pharmacist.||
7217|105|S|   In the US -||
7217|106|S|   Call your doctor for medical advice about side effects. You||
7217|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7217|108|S|www.fda.gov/medwatch.||
7217|109|S|   In Canada - Call your doctor for medical advice about side||
7217|110|S|effects. You may report side effects to Health Canada at||
7217|111|S|1-866-234-2345.||
7217|112|B|||
7217|113|P|PRECAUTIONS:  Before taking lamotrigine, tell your doctor or||
7217|114|P|pharmacist if you are allergic to it; or if you have any other||
7217|115|P|allergies. This product may contain inactive ingredients, which||
7217|116|P|can cause allergic reactions or other problems. Talk to your||
7217|117|P|pharmacist for more details.||
7217|118|P|   Before using this medication, tell your doctor or pharmacist||
7217|119|P|your medical history, especially of: kidney disease, liver||
7217|120|P|disease, heart problems (such as irregular heartbeat, heart||
7217|121|P|block, heart failure).||
7217|122|P|   This drug may make you dizzy or drowsy or blur your vision.||
7217|123|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7217|124|P|drowsy. Do not drive, use machinery, or do anything that needs||
7217|125|P|alertness or clear vision until you can do it safely. Limit||
7217|126|P|alcoholic beverages. Talk to your doctor if you are using||
7217|127|P|marijuana (cannabis).||
7217|128|P|   Before having surgery, tell your doctor or dentist about all||
7217|129|P|the products you use (including prescription drugs,||
7217|130|P|nonprescription drugs, and herbal products).||
7217|131|P|   Children may be at greater risk for skin rashes while taking||
7217|132|P|this drug. See also Warning section.||
7217|133|P|   Older adults may be more sensitive to the side effects of this||
7217|134|P|drug, especially dizziness, loss of coordination, or fainting.||
7217|135|P|These side effects can increase the risk of falling.||
7217|136|P|   During pregnancy, this medication should be used only when||
7217|137|P|clearly needed. Discuss the risks and benefits with your doctor.||
7217|138|P|   This drug passes into breast milk and may have undesirable||
7217|139|P|effects on a nursing infant. Consult your doctor before||
7217|140|P|breastfeeding.||
7217|141|B|||
7217|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7217|143|I|medications work or increase your risk for serious side effects.||
7217|144|I|This document does not contain all possible drug interactions.||
7217|145|I|Keep a list of all the products you use (including||
7217|146|I|prescription/nonprescription drugs and herbal products) and share||
7217|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
7217|148|I|the dosage of any medicines without your doctor's approval.||
7217|149|I|   Some products that may interact with this drug include:||
7217|150|I|dofetilide, orlistat.||
7217|151|I|   Other medications can affect the removal of lamotrigine from||
7217|152|I|your body, which may affect how lamotrigine works. Examples||
7217|153|I|include hormonal birth control (such as pills, patches),||
7217|154|I|estrogens, other medications to treat seizures (such as||
7217|155|I|phenobarbital, primidone, valproic acid), rifampin, ritonavir,||
7217|156|I|among others. Your doctor may need to adjust your dose of||
7217|157|I|lamotrigine if you are on these medications.||
7217|158|I|   This medication may decrease the effectiveness of hormonal||
7217|159|I|birth control such as pills, patch, or ring. This could cause||
7217|160|I|pregnancy. Discuss with your doctor or pharmacist if you should||
7217|161|I|use reliable backup birth control methods while using this||
7217|162|I|medication. Also tell your doctor if you have any new spotting or||
7217|163|I|breakthrough bleeding, because these may be signs that your birth||
7217|164|I|control is not working well.||
7217|165|I|   Tell your doctor or pharmacist if you are taking other||
7217|166|I|products that cause drowsiness including alcohol, marijuana||
7217|167|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
7217|168|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
7217|169|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
7217|170|I|codeine).||
7217|171|I|   Check the labels on all your medicines (such as allergy or||
7217|172|I|cough-and-cold products) because they may contain ingredients||
7217|173|I|that cause drowsiness. Ask your pharmacist about using those||
7217|174|I|products safely.||
7217|175|I|   This medication may interfere with certain lab tests (such as||
7217|176|I|urine drug screening tests), possibly causing false test results.||
7217|177|I|Make sure lab personnel and all your doctors know you use this||
7217|178|I|drug.||
7217|179|B|||
7217|180|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7217|181|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7217|182|O|poison control center right away. US residents can call||
7217|183|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7217|184|O|Symptoms of overdose may include: severe drowsiness, unusual eye||
7217|185|O|movements, loss of consciousness.||
7217|186|B|||
7217|187|N|NOTES:  Do not share this medication with others.||
7217|188|N|   Lab and/or medical tests (such as liver/kidney function,||
7217|189|N|complete blood count) may be done while you are taking this||
7217|190|N|medication. Keep all medical and lab appointments. Consult your||
7217|191|N|doctor for more details.||
7217|192|N|   There are different types of this medication available. Some||
7217|193|N|do not have the same effects. There are also some medications||
7217|194|N|that sound the same as this product. Make sure you have the right||
7217|195|N|product before taking it.||
7217|196|B|||
7217|197|D|MISSED DOSE:  It is important to take each dose at the scheduled||
7217|198|D|time. If you miss a dose, take it as soon as you remember. If it||
7217|199|D|is near the time of the next dose, skip the missed dose. Take||
7217|200|D|your next dose at the regular time. Do not double the dose to||
7217|201|D|catch up.||
7217|202|B|||
7217|203|R|STORAGE:  Store at room temperature away from light and moisture.||
7217|204|R|Do not store in the bathroom. Once the bottle for the liquid form||
7217|205|R|is opened, the medication expires after 90 days. Keep all||
7217|206|R|medications away from children and pets.||
7217|207|R|   Do not flush medications down the toilet or pour them into a||
7217|208|R|drain unless instructed to do so. Properly discard this product||
7217|209|R|when it is expired or no longer needed. Consult your pharmacist||
7217|210|R|or local waste disposal company.||
7217|211|B|||
7217|212|M|MEDICAL ALERT:  Your condition can cause complications in a||
7217|213|M|medical emergency. For information about enrolling in MedicAlert,||
7217|214|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7217|215|B|||
7217|216|A|Information last revised November 2025.||
7217|217|A|Copyright(c) 2025 First Databank, Inc.||
7217|218|B|||
7218|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7218|002|Z|does NOT have all possible information about this product. This||
7218|003|Z|information does not assure that this product is safe, effective,||
7218|004|Z|or appropriate for you. This information is not individual||
7218|005|Z|medical advice and does not substitute for the advice of your||
7218|006|Z|health care professional. Always ask your health care||
7218|007|Z|professional for complete information about this product and your||
7218|008|Z|specific health needs.||
7218|009|B|||
7218|010|T|RIVASTIGMINE SOLUTION - ORAL||
7218|011|F|(riv-uh-STIG-meen)||
7218|012|B|||
7218|013|C|COMMON BRAND NAME(S): Exelon||
7218|014|B|||
7218|015|U|USES:  Rivastigmine is used to treat confusion (dementia) related||
7218|016|U|to Alzheimer's disease and to Parkinson's disease. Rivastigmine||
7218|017|U|does not cure either of these diseases, but it may improve||
7218|018|U|memory, awareness, and the ability to perform daily functions.||
7218|019|U|This medication works by restoring the balance of natural||
7218|020|U|substances (neurotransmitters) in the brain.||
7218|021|B|||
7218|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7218|023|H|from your pharmacist before you start taking rivastigmine and||
7218|024|H|each time you get a refill. If you have any questions, ask your||
7218|025|H|doctor or pharmacist.||
7218|026|H|   Follow all directions for the proper use of this medication.||
7218|027|H|Read the instruction sheet that is included with this product.||
7218|028|H|Using the provided syringe, measure out the prescribed amount of||
7218|029|H|this medication. The dose may be swallowed directly from the||
7218|030|H|syringe or mixed with a small glass of water, cold fruit juice,||
7218|031|H|or soda. Stir and drink the entire mixture within 4 hours of||
7218|032|H|mixing. Do not store for future use. Do not mix this medication||
7218|033|H|with other liquids. Ask your doctor or pharmacist if you are||
7218|034|H|unclear about how to take this medication.||
7218|035|H|   Take this medication with food as directed by your doctor,||
7218|036|H|usually twice daily (in the morning and evening). The dosage is||
7218|037|H|based on your medical condition and response to treatment. To||
7218|038|H|reduce your risk of side effects (such as nausea and diarrhea),||
7218|039|H|your doctor will start this medication at a low dose and||
7218|040|H|gradually increase your dose over 2 to 4 weeks.||
7218|041|H|   Use this medication regularly in order to get the most benefit||
7218|042|H|from it. Do not stop taking it or increase the dosage unless your||
7218|043|H|doctor instructs you to do so. Do not use this drug more often||
7218|044|H|than prescribed.||
7218|045|H|   If you do not take rivastigmine for 3 or more days in row,||
7218|046|H|talk with your doctor before starting again. You may need to||
7218|047|H|restart at a lower dose.||
7218|048|H|   Tell your doctor if your condition gets worse.||
7218|049|B|||
7218|050|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite/weight loss,||
7218|051|S|diarrhea, weakness, dizziness, drowsiness, and shakiness (tremor)||
7218|052|S|may occur as your body adjusts to the drug. These effects usually||
7218|053|S|occur when you start the medication or increase the dose and then||
7218|054|S|lessen. If any of these effects last or get worse, tell your||
7218|055|S|doctor or pharmacist promptly.||
7218|056|S|   Remember that this medication has been prescribed because your||
7218|057|S|doctor has judged that the benefit to you is greater than the||
7218|058|S|risk of side effects. Many people using this medication do not||
7218|059|S|have serious side effects.||
7218|060|S|   Tell your doctor right away if you have any serious side||
7218|061|S|effects, including: slow heartbeat, black stools, vomit that||
7218|062|S|looks like coffee grounds, severe stomach/abdominal pain,||
7218|063|S|seizures, trouble urinating.||
7218|064|S|   Get medical help right away if you have any very serious side||
7218|065|S|effects, including: fast/irregular heartbeat, severe dizziness,||
7218|066|S|fainting.||
7218|067|S|   A very serious allergic reaction to this drug is rare.||
7218|068|S|However, get medical help right away if you notice any symptoms||
7218|069|S|of a serious allergic reaction, including: rash, itching/swelling||
7218|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7218|071|S|breathing.||
7218|072|S|   This is not a complete list of possible side effects. If you||
7218|073|S|notice other effects not listed above, contact your doctor or||
7218|074|S|pharmacist.||
7218|075|S|   In the US -||
7218|076|S|   Call your doctor for medical advice about side effects. You||
7218|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7218|078|S|www.fda.gov/medwatch.||
7218|079|S|   In Canada - Call your doctor for medical advice about side||
7218|080|S|effects. You may report side effects to Health Canada at||
7218|081|S|1-866-234-2345.||
7218|082|B|||
7218|083|P|PRECAUTIONS:  Before taking rivastigmine, tell your doctor or||
7218|084|P|pharmacist if you are allergic to it (including having a rash||
7218|085|P|while using rivastigmine patches); or if you have any other||
7218|086|P|allergies. This product may contain inactive ingredients, which||
7218|087|P|can cause allergic reactions or other problems. Talk to your||
7218|088|P|pharmacist for more details.||
7218|089|P|   Before using this medication, tell your doctor or pharmacist||
7218|090|P|your medical history, especially of: breathing/lung problems||
7218|091|P|(such as asthma, COPD-chronic obstructive pulmonary disease),||
7218|092|P|stomach/intestinal problems (such as ulcers, bleeding), heart||
7218|093|P|problems (such as sick sinus syndrome, other conduction||
7218|094|P|disorders), fainting, seizures, problems urinating (such as due||
7218|095|P|to enlarged prostate).||
7218|096|P|   Rivastigmine may cause a condition that affects the heart||
7218|097|P|rhythm (QT prolongation). QT prolongation can rarely cause||
7218|098|P|serious (rarely fatal) fast/irregular heartbeat and other||
7218|099|P|symptoms (such as severe dizziness, fainting) that need medical||
7218|100|P|attention right away.||
7218|101|P|   The risk of QT prolongation may be increased if you have||
7218|102|P|certain medical conditions or are taking other drugs that may||
7218|103|P|cause QT prolongation. Before using rivastigmine, tell your||
7218|104|P|doctor or pharmacist of all the drugs you take and if you have||
7218|105|P|any of the following conditions: certain heart problems (heart||
7218|106|P|failure, slow heartbeat, QT prolongation in the EKG), family||
7218|107|P|history of certain heart problems (QT prolongation in the EKG,||
7218|108|P|sudden cardiac death).||
7218|109|P|   Low levels of potassium or magnesium in the blood may also||
7218|110|P|increase your risk of QT prolongation. This risk may increase if||
7218|111|P|you use certain drugs (such as diuretics/"water pills") or if you||
7218|112|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7218|113|P|Talk to your doctor about using rivastigmine safely.||
7218|114|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7218|115|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7218|116|P|machinery, or do anything that needs alertness until you can do||
7218|117|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
7218|118|P|are using marijuana (cannabis).||
7218|119|P|   Before having surgery, tell your doctor or dentist about all||
7218|120|P|the products you use (including prescription drugs,||
7218|121|P|nonprescription drugs, and herbal products).||
7218|122|P|   Older adults may be more sensitive to the side effects of this||
7218|123|P|drug, especially QT prolongation (see above).||
7218|124|P|   During pregnancy, this medication should be used only when||
7218|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
7218|126|P|   It is unknown if this medication passes into breast milk.||
7218|127|P|Consult your doctor before breastfeeding.||
7218|128|B|||
7218|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7218|130|I|medications work or increase your risk for serious side effects.||
7218|131|I|This document does not contain all possible drug interactions.||
7218|132|I|Keep a list of all the products you use (including||
7218|133|I|prescription/nonprescription drugs and herbal products) and share||
7218|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
7218|135|I|the dosage of any medicines without your doctor's approval.||
7218|136|I|   Some products that may interact with this drug include:||
7218|137|I|aspirin/nonsteroidal anti-inflammatory drugs (NSAIDs, such as||
7218|138|I|ibuprofen, naproxen), metoclopramide.||
7218|139|I|   Check all prescription and nonprescription medicine labels||
7218|140|I|carefully since many medications contain pain relievers/fever||
7218|141|I|reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that if||
7218|142|I|taken together with rivastigmine may increase your risk for||
7218|143|I|stomach/intestinal bleeding. However, if your doctor has told you||
7218|144|I|to take low-dose aspirin to prevent heart attack or stroke||
7218|145|I|(usually 81-162 milligrams a day), you should keep taking the||
7218|146|I|aspirin unless your doctor tells you not to. Ask your doctor or||
7218|147|I|pharmacist for more details.||
7218|148|B|||
7218|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7218|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7218|151|O|poison control center right away. US residents can call||
7218|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7218|153|O|Symptoms of overdose may include: nausea/vomiting that is severe||
7218|154|O|or doesn't stop, excessive sweating, very slow heartbeat, slow or||
7218|155|O|shallow breathing, seizures.||
7218|156|B|||
7218|157|N|NOTES:  Do not share this medication with others.||
7218|158|N|   Lab and/or medical tests (such as weight) should be done while||
7218|159|N|you are taking this medication. Keep all medical and lab||
7218|160|N|appointments. Consult your doctor for more details.||
7218|161|B|||
7218|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7218|163|D|remember. If it is near the time of the next dose, skip the||
7218|164|D|missed dose. Take your next dose at the regular time. Do not||
7218|165|D|double the dose to catch up.||
7218|166|B|||
7218|167|R|STORAGE:  Store upright at room temperature. Keep all medications||
7218|168|R|away from children and pets.||
7218|169|R|   Do not flush medications down the toilet or pour them into a||
7218|170|R|drain unless instructed to do so. Properly discard this product||
7218|171|R|when it is expired or no longer needed. Consult your pharmacist||
7218|172|R|or local waste disposal company.||
7218|173|B|||
7218|174|A|Information last revised February 2025.||
7218|175|A|Copyright(c) 2025 First Databank, Inc.||
7218|176|B|||
7220|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7220|002|Z|does NOT have all possible information about this product. This||
7220|003|Z|information does not assure that this product is safe, effective,||
7220|004|Z|or appropriate for you. This information is not individual||
7220|005|Z|medical advice and does not substitute for the advice of your||
7220|006|Z|health care professional. Always ask your health care||
7220|007|Z|professional for complete information about this product and your||
7220|008|Z|specific health needs.||
7220|009|B|||
7220|010|T|COLLAGENASE OINTMENT - TOPICAL||
7220|011|F|(coal-ADGE-ih-naze)||
7220|012|B|||
7220|013|C|COMMON BRAND NAME(S): Santyl||
7220|014|B|||
7220|015|U|USES:  This product is used to help the healing of burns and skin||
7220|016|U|ulcers. Collagenase is an enzyme. It works by helping to break up||
7220|017|U|and remove dead skin and tissue. This effect may also help||
7220|018|U|antibiotics to work better and speed up your body's natural||
7220|019|U|healing process.||
7220|020|B|||
7220|021|H|HOW TO USE:  This medication is for use on the skin only. Apply||
7220|022|H|this medication as directed by your doctor, usually once daily.||
7220|023|H|If the dressing becomes soiled, collagenase may be applied more||
7220|024|H|often.||
7220|025|H|   To apply, wash hands first. Clean the area as directed by your||
7220|026|H|doctor. Cleaning solutions such as hydrogen peroxide, normal||
7220|027|H|saline, or Dakin's solution may be used. If your doctor has||
7220|028|H|directed you to use an antibiotic powder, apply it first before||
7220|029|H|applying this medication. Use a wooden spatula or a gauze pad to||
7220|030|H|carefully apply the collagenase ointment directly to the affected||
7220|031|H|area. Bandage securely. If you are unclear about how to clean the||
7220|032|H|affected area or apply this medication, consult your doctor.||
7220|033|H|   Avoid applying near the eyes. Be careful to apply the ointment||
7220|034|H|only within the affected area. Wash hands thoroughly after||
7220|035|H|applying the ointment.||
7220|036|B|||
7220|037|S|SIDE EFFECTS:  Pain or a burning feeling at the affected area may||
7220|038|S|occur. Temporary redness/irritation may also occur in the skin||
7220|039|S|around the affected area. If any of these effects last or get||
7220|040|S|worse, tell your doctor or pharmacist promptly. To avoid||
7220|041|S|redness/irritation in the surrounding skin, be careful to apply||
7220|042|S|the ointment only within the affected area.||
7220|043|S|   Remember that this medication has been prescribed because your||
7220|044|S|doctor has judged that the benefit to you is greater than the||
7220|045|S|risk of side effects. Many people using this medication do not||
7220|046|S|have serious side effects.||
7220|047|S|   Treatment of burns and skin ulcers by breaking up and removing||
7220|048|S|dead skin and tissue may rarely increase the risk for serious||
7220|049|S|infection (sepsis). Tell your doctor right away if you notice any||
7220|050|S|symptoms of serious infection, including: fever/chills, fast||
7220|051|S|breathing (hyperventilation), fast heartbeat, warm skin,||
7220|052|S|weakness.||
7220|053|S|   A very serious allergic reaction to this drug is rare.||
7220|054|S|However, get medical help right away if you notice any symptoms||
7220|055|S|of a serious allergic reaction, including: rash, itching/swelling||
7220|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7220|057|S|breathing.||
7220|058|S|   This is not a complete list of possible side effects. If you||
7220|059|S|notice other effects not listed above, contact your doctor or||
7220|060|S|pharmacist.||
7220|061|S|   In the US -||
7220|062|S|   Call your doctor for medical advice about side effects. You||
7220|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7220|064|S|www.fda.gov/medwatch.||
7220|065|S|   In Canada - Call your doctor for medical advice about side||
7220|066|S|effects. You may report side effects to Health Canada at||
7220|067|S|1-866-234-2345.||
7220|068|B|||
7220|069|P|PRECAUTIONS:  Before using collagenase, tell your doctor or||
7220|070|P|pharmacist if you are allergic to it; or if you have any other||
7220|071|P|allergies. This product may contain inactive ingredients, which||
7220|072|P|can cause allergic reactions or other problems. Talk to your||
7220|073|P|pharmacist for more details.||
7220|074|P|   Before using this medication, tell your doctor or pharmacist||
7220|075|P|your medical history.||
7220|076|P|   Avoid using solutions that contain acid or metal as soaking||
7220|077|P|liquids because these will decrease the effect of collagenase||
7220|078|P|ointment (see also Drug Interactions section).||
7220|079|P|   Before having surgery, tell your doctor or dentist about all||
7220|080|P|the products you use (including prescription drugs,||
7220|081|P|nonprescription drugs, and herbal products).||
7220|082|P|   During pregnancy, this medication should be used only when||
7220|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
7220|084|P|   It is unknown if this medication passes into breast milk.||
7220|085|P|Consult your doctor before breastfeeding.||
7220|086|B|||
7220|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7220|088|I|medications work or increase your risk for serious side effects.||
7220|089|I|This document does not contain all possible drug interactions.||
7220|090|I|Keep a list of all the products you use (including||
7220|091|I|prescription/nonprescription drugs and herbal products) and share||
7220|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
7220|093|I|the dosage of any medicines without your doctor's approval.||
7220|094|I|   Some products that may interact with this drug include:||
7220|095|I|antiseptic skin products (especially those containing heavy||
7220|096|I|metals such as lead, mercury, silver).||
7220|097|I|   Skin products containing heavy metals may decrease the effect||
7220|098|I|of collagenase. If the affected area has been exposed to one of||
7220|099|I|these products, wash the area well with normal saline solution||
7220|100|I|before applying this ointment.||
7220|101|B|||
7220|102|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7220|103|O|has overdosed and has serious symptoms such as passing out or||
7220|104|O|trouble breathing, call 911. Otherwise, call a poison control||
7220|105|O|center right away. US residents can call 1-800-222-1222. Canada||
7220|106|O|residents can call 1-844-764-7669.||
7220|107|B|||
7220|108|N|NOTES:  Do not share this medication with others.||
7220|109|B|||
7220|110|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7220|111|D|If it is near the time of the next dose, skip the missed dose.||
7220|112|D|Use your next dose at the regular time. Do not double the dose to||
7220|113|D|catch up.||
7220|114|B|||
7220|115|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
7220|116|R|medications away from children and pets.||
7220|117|R|   Do not flush medications down the toilet or pour them into a||
7220|118|R|drain unless instructed to do so. Properly discard this product||
7220|119|R|when it is expired or no longer needed. Consult your pharmacist||
7220|120|R|or local waste disposal company.||
7220|121|B|||
7220|122|A|Information last revised May 2024.||
7220|123|A|Copyright(c) 2025 First Databank, Inc.||
7220|124|B|||
7221|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7221|002|Z|does NOT have all possible information about this product. This||
7221|003|Z|information does not assure that this product is safe, effective,||
7221|004|Z|or appropriate for you. This information is not individual||
7221|005|Z|medical advice and does not substitute for the advice of your||
7221|006|Z|health care professional. Always ask your health care||
7221|007|Z|professional for complete information about this product and your||
7221|008|Z|specific health needs.||
7221|009|B|||
7221|010|T|POTASSIUM/SODIUM PHOSPHATE - ORAL||
7221|011|F|(poh-TASS-ee-um/SO-dee-um FOSS-fate)||
7221|012|B|||
7221|013|C|COMMON BRAND NAME(S): K-Phos||
7221|014|B|||
7221|015|U|USES:  This drug may be used in people who cannot get enough||
7221|016|U|phosphorus from their diets. Phosphorus is a natural body mineral||
7221|017|U|that is very important for building and maintaining bone. It||
7221|018|U|helps control the amount of calcium in the body and urine.||
7221|019|B|||
7221|020|H|HOW TO USE:  Take this medication by mouth as directed by your||
7221|021|H|doctor, usually 4 times a day with meals and at bedtime. Take||
7221|022|H|this medication with a full glass of water (8 ounces or 240||
7221|023|H|milliliters). Do not lie down for at least 10 minutes after||
7221|024|H|taking this medication.||
7221|025|H|   Take this medication regularly in order to get the most||
7221|026|H|benefit from it. To help you remember, take it at the same times||
7221|027|H|each day.||
7221|028|H|   The dosage is based on your medical condition and response to||
7221|029|H|treatment.||
7221|030|H|   Take this medication 2-3 hours before or after taking any||
7221|031|H|products containing magnesium, aluminum, or calcium. Some||
7221|032|H|examples include quinapril, vitamins/minerals, and antacids.||
7221|033|H|Dairy products (such as milk, yogurt), juice with added calcium,||
7221|034|H|sucralfate, bismuth subsalicylate, iron, and zinc are also||
7221|035|H|included. These products bind with phosphate, preventing its full||
7221|036|H|absorption.||
7221|037|H|   Take this medication as prescribed. Do not increase your dose||
7221|038|H|or take this more often without your doctor's approval.||
7221|039|B|||
7221|040|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, dizziness, or headache||
7221|041|S|may occur. If any of these effects last or get worse, tell your||
7221|042|S|doctor or pharmacist promptly.||
7221|043|S|   Remember that this medication has been prescribed because your||
7221|044|S|doctor has judged that the benefit to you is greater than the||
7221|045|S|risk of side effects. Many people using this medication do not||
7221|046|S|have serious side effects.||
7221|047|S|   When this medication is first started, there is a chance an||
7221|048|S|old kidney stone will be passed.||
7221|049|S|   Tell your doctor right away if you have any serious side||
7221|050|S|effects, including: bone/joint aches, muscle cramps, stomach||
7221|051|S|pain, swollen hands/legs/feet, confusion, fast/irregular||
7221|052|S|heartbeat, seizures, unusual weakness, tingling/numbness of the||
7221|053|S|hands/feet, signs of kidney problems (such as change in the||
7221|054|S|amount of urine).||
7221|055|S|   A very serious allergic reaction to this drug is rare.||
7221|056|S|However, get medical help right away if you notice any symptoms||
7221|057|S|of a serious allergic reaction, including: rash, itching/swelling||
7221|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7221|059|S|breathing.||
7221|060|S|   This is not a complete list of possible side effects. If you||
7221|061|S|notice other effects not listed above, contact your doctor or||
7221|062|S|pharmacist.||
7221|063|S|   In the US -||
7221|064|S|   Call your doctor for medical advice about side effects. You||
7221|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7221|066|S|www.fda.gov/medwatch.||
7221|067|S|   In Canada - Call your doctor for medical advice about side||
7221|068|S|effects. You may report side effects to Health Canada at||
7221|069|S|1-866-234-2345.||
7221|070|B|||
7221|071|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
7221|072|P|pharmacist if you are allergic to it; or if you have any other||
7221|073|P|allergies. This product may contain inactive ingredients, which||
7221|074|P|can cause allergic reactions or other problems. Talk to your||
7221|075|P|pharmacist for more details.||
7221|076|P|   Before using this medication, tell your doctor or pharmacist||
7221|077|P|your medical history, especially of: high||
7221|078|P|phosphate/potassium/sodium levels, adrenal gland problems (such||
7221|079|P|as Addison's disease), extra fluid in the body (such as swelling||
7221|080|P|of arms/legs, fluid in the lungs), bone problems (such as||
7221|081|P|osteomalacia, rickets), heart disease (such as heart failure,||
7221|082|P|irregular heartbeat), high blood pressure, a certain hormone||
7221|083|P|problem (hypoparathyroidism), kidney disease (including kidney||
7221|084|P|stones), liver disease, certain muscle problem (myotonia||
7221|085|P|congenita), pancreatitis, late pregnancy problems (preeclampsia),||
7221|086|P|dehydration, severe burns/wounds, special diet (such as sodium-||
7221|087|P|or potassium-restricted diet).||
7221|088|P|   This medication contains sodium. Consult your doctor for more||
7221|089|P|information if you are on a salt-restricted diet or if increased||
7221|090|P|salt intake could worsen your condition (for example, if you have||
7221|091|P|heart failure).||
7221|092|P|   Before having surgery, tell your doctor or dentist about all||
7221|093|P|the products you use (including prescription drugs,||
7221|094|P|nonprescription drugs, and herbal products).||
7221|095|P|   Older adults may be more sensitive to the side effects of this||
7221|096|P|drug, especially swelling legs/feet (due to sodium and water||
7221|097|P|retention).||
7221|098|P|   During pregnancy, this medication should be used only when||
7221|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
7221|100|P|   It is unknown if this drug passes into breast milk. Consult||
7221|101|P|your doctor before breastfeeding.||
7221|102|B|||
7221|103|I|DRUG INTERACTIONS:  See also How to Use section.||
7221|104|I|   Drug interactions may change how your medications work or||
7221|105|I|increase your risk for serious side effects. This document does||
7221|106|I|not contain all possible drug interactions. Keep a list of all||
7221|107|I|the products you use (including prescription/nonprescription||
7221|108|I|drugs and herbal products) and share it with your doctor and||
7221|109|I|pharmacist. Do not start, stop, or change the dosage of any||
7221|110|I|medicines without your doctor's approval.||
7221|111|I|   Some products that may interact with this drug include:||
7221|112|I|aspirin, burosumab, digoxin, eplerenone, high blood pressure||
7221|113|I|drugs (including ACE inhibitors such as lisinopril, ARBs such as||
7221|114|I|valsartan), potassium supplements/salt substitutes, vitamin||
7221|115|I|products (such as vitamin D, calcium), certain "water pills"||
7221|116|I|(including potassium-sparing diuretics such as||
7221|117|I|amiloride/spironolactone/triamterene).||
7221|118|I|   If your doctor has told you to take low-dose aspirin to||
7221|119|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
7221|120|I|you should keep taking the aspirin unless your doctor tells you||
7221|121|I|not to. Ask your doctor or pharmacist for more details.||
7221|122|B|||
7221|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7221|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7221|125|O|poison control center right away. US residents can call||
7221|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7221|127|O|Symptoms of overdose may include: severe diarrhea, muscle spasms.||
7221|128|B|||
7221|129|N|NOTES:  Do not share this medication with others.||
7221|130|N|   Lab and/or medical tests (such as||
7221|131|N|calcium/phosphorus/potassium/sodium levels, kidney function)||
7221|132|N|should be done while you are taking this medication. Keep all||
7221|133|N|medical and lab appointments. Consult your doctor for more||
7221|134|N|details.||
7221|135|B|||
7221|136|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7221|137|D|remember. If it is near the time of the next dose, skip the||
7221|138|D|missed dose. Take your next dose at the regular time. Do not||
7221|139|D|double the dose to catch up.||
7221|140|B|||
7221|141|R|STORAGE:  Store at room temperature away from heat, light, and||
7221|142|R|moisture. Do not store in the bathroom. Keep all medications away||
7221|143|R|from children and pets||
7221|144|R|   Do not flush medications down the toilet or pour them into a||
7221|145|R|drain unless instructed to do so. Properly discard this product||
7221|146|R|when it is expired or no longer needed. Consult your pharmacist||
7221|147|R|or local waste disposal company.||
7221|148|B|||
7221|149|A|Information last revised September 2025.||
7221|150|A|Copyright(c) 2025 First Databank, Inc.||
7221|151|B|||
7225|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7225|002|Z|does NOT have all possible information about this product. This||
7225|003|Z|information does not assure that this product is safe, effective,||
7225|004|Z|or appropriate for you. This information is not individual||
7225|005|Z|medical advice and does not substitute for the advice of your||
7225|006|Z|health care professional. Always ask your health care||
7225|007|Z|professional for complete information about this product and your||
7225|008|Z|specific health needs.||
7225|009|B|||
7225|010|T|NISOLDIPINE (8.5, 17, 25.5, OR 34 MG) SUSTAINED-ACTION - ORAL||
7225|011|F|(nye-SOL-di-peen)||
7225|012|B|||
7225|013|C|COMMON BRAND NAME(S): Sular||
7225|014|B|||
7225|015|U|USES:  Nisoldipine is used with or without other medications to||
7225|016|U|treat high blood pressure (hypertension). Lowering high blood||
7225|017|U|pressure helps prevent strokes, heart attacks, and kidney||
7225|018|U|problems. Nisoldipine is called a calcium channel blocker. It||
7225|019|U|works by relaxing blood vessels so blood can flow more easily.||
7225|020|B|||
7225|021|H|HOW TO USE:  Take this medication by mouth on an empty stomach (1||
7225|022|H|hour before or 2 hours after a meal) as directed by your doctor,||
7225|023|H|usually once daily.||
7225|024|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
7225|025|H|Doing so can release all of the drug at once, increasing the risk||
7225|026|H|of side effects.||
7225|027|H|   This medication comes in different sustained-action forms with||
7225|028|H|different strengths. Check with your doctor or pharmacist that||
7225|029|H|you are taking the correct dose and form. Do not take a different||
7225|030|H|strength or form without checking with your doctor or pharmacist||
7225|031|H|first.||
7225|032|H|   Avoid eating grapefruit or drinking grapefruit juice while||
7225|033|H|using this medication unless your doctor or pharmacist says you||
7225|034|H|may do so safely. Grapefruit can increase the chance of side||
7225|035|H|effects with this medicine. Ask your doctor or pharmacist for||
7225|036|H|more details.||
7225|037|H|   The dosage is based on your medical condition and response to||
7225|038|H|treatment. Your doctor may gradually increase your dose. Follow||
7225|039|H|your doctor's instructions carefully.||
7225|040|H|   Use this medication regularly to get the most benefit from it.||
7225|041|H|To help you remember, take it at the same time each day. Keep||
7225|042|H|taking this medication even if you feel well. Most people with||
7225|043|H|high blood pressure do not feel sick.||
7225|044|H|   Tell your doctor if your condition does not get better or if||
7225|045|H|it gets worse (your blood pressure readings remain high or||
7225|046|H|increase).||
7225|047|B|||
7225|048|S|SIDE EFFECTS:  Dizziness, swelling ankles/feet, flushing, or||
7225|049|S|headache may occur. If any of these effects last or get worse,||
7225|050|S|tell your doctor or pharmacist promptly.||
7225|051|S|   To reduce the risk of dizziness and lightheadedness, get up||
7225|052|S|slowly when rising from a sitting or lying position.||
7225|053|S|   An empty tablet shell may appear in your stool. This effect is||
7225|054|S|harmless because your body has already absorbed the medication.||
7225|055|S|   Remember that this medication has been prescribed because your||
7225|056|S|doctor has judged that the benefit to you is greater than the||
7225|057|S|risk of side effects. Many people using this medication do not||
7225|058|S|have serious side effects.||
7225|059|S|   Tell your doctor right away if you have any serious side||
7225|060|S|effects, including: fast/irregular/pounding heartbeat, fainting,||
7225|061|S|vision changes.||
7225|062|S|   Some people who already have severe heart disease may rarely||
7225|063|S|develop worsening chest pain or a heart attack after starting||
7225|064|S|this medication or increasing the dose. Get medical help right||
7225|065|S|away if you experience: worsening chest pain, symptoms of a heart||
7225|066|S|attack (such as chest/jaw/left arm pain, shortness of breath,||
7225|067|S|unusual sweating).||
7225|068|S|   A very serious allergic reaction to this drug is rare.||
7225|069|S|However, get medical help right away if you notice any symptoms||
7225|070|S|of a serious allergic reaction, including: rash, itching/swelling||
7225|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7225|072|S|breathing.||
7225|073|S|   This is not a complete list of possible side effects. If you||
7225|074|S|notice other effects not listed above, contact your doctor or||
7225|075|S|pharmacist.||
7225|076|S|   In the US -||
7225|077|S|   Call your doctor for medical advice about side effects. You||
7225|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7225|079|S|www.fda.gov/medwatch.||
7225|080|S|   In Canada - Call your doctor for medical advice about side||
7225|081|S|effects. You may report side effects to Health Canada at||
7225|082|S|1-866-234-2345.||
7225|083|B|||
7225|084|P|PRECAUTIONS:  Before taking nisoldipine, tell your doctor or||
7225|085|P|pharmacist if you are allergic to it; or to other dihydropyridine||
7225|086|P|calcium channel blockers (such as amlodipine, nifedipine); or if||
7225|087|P|you have any other allergies. This product may contain inactive||
7225|088|P|ingredients, which can cause allergic reactions or other||
7225|089|P|problems. Talk to your pharmacist for more details.||
7225|090|P|   Before using this medication, tell your doctor or pharmacist||
7225|091|P|your medical history, especially of: a certain structural heart||
7225|092|P|problem (aortic stenosis), liver disease.||
7225|093|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7225|094|P|can make you more dizzy. Do not drive, use machinery, or do||
7225|095|P|anything that needs alertness until you can do it safely. Limit||
7225|096|P|alcoholic beverages. Talk to your doctor if you are using||
7225|097|P|marijuana (cannabis).||
7225|098|P|   Before having surgery, tell your doctor or dentist about all||
7225|099|P|the products you use (including prescription drugs,||
7225|100|P|nonprescription drugs, and herbal products).||
7225|101|P|   During pregnancy, this medication should be used only when||
7225|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
7225|103|P|   It is unknown if this medication passes into breast milk.||
7225|104|P|Consult your doctor before breastfeeding.||
7225|105|B|||
7225|106|I|DRUG INTERACTIONS:  See also the How to Use section.||
7225|107|I|   Drug interactions may change how your medications work or||
7225|108|I|increase your risk for serious side effects. This document does||
7225|109|I|not contain all possible drug interactions. Keep a list of all||
7225|110|I|the products you use (including prescription/nonprescription||
7225|111|I|drugs and herbal products) and share it with your doctor and||
7225|112|I|pharmacist. Do not start, stop, or change the dosage of any||
7225|113|I|medicines without your doctor's approval.||
7225|114|I|   Other medications can affect the removal of nisoldipine from||
7225|115|I|your body, which may affect how nisoldipine works. Examples||
7225|116|I|include apalutamide, azole antifungals (such as itraconazole,||
7225|117|I|ketoconazole), cimetidine, enzalutamide, ivosidenib, macrolide||
7225|118|I|antibiotics (such as erythromycin), mitotane, rifamycins (such as||
7225|119|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
7225|120|I|as carbamazepine, phenytoin), among others.||
7225|121|I|   Some products have ingredients that could raise your heart||
7225|122|I|rate or blood pressure. Tell your pharmacist what products you||
7225|123|I|are using, and ask how to use them safely (especially||
7225|124|I|cough-and-cold products, diet aids, or NSAIDs such as||
7225|125|I|ibuprofen/naproxen).||
7225|126|B|||
7225|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7225|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7225|129|O|poison control center right away. US residents can call||
7225|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7225|131|B|||
7225|132|N|NOTES:  Do not share this medication with others. Talk with your||
7225|133|N|doctor about making lifestyle changes that may help this||
7225|134|N|medication work better (such as stress reduction programs,||
7225|135|N|exercise, and dietary changes).||
7225|136|N|   Lab and/or medical tests (such as liver function, heart exam,||
7225|137|N|blood pressure) may be done while you are taking this medication.||
7225|138|N|Keep all medical and lab appointments. Consult your doctor for||
7225|139|N|more details.||
7225|140|N|   Have your blood pressure checked regularly while taking this||
7225|141|N|medication. Learn how to monitor your own blood pressure at home,||
7225|142|N|and share the results with your doctor.||
7225|143|B|||
7225|144|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7225|145|D|remember. If it is near the time of the next dose, skip the||
7225|146|D|missed dose. Take your next dose at the regular time. Do not||
7225|147|D|double the dose to catch up.||
7225|148|B|||
7225|149|R|STORAGE:  Store at room temperature away from light and moisture.||
7225|150|R|Do not store in the bathroom. Keep all medications away from||
7225|151|R|children and pets.||
7225|152|R|   Do not flush medications down the toilet or pour them into a||
7225|153|R|drain unless instructed to do so. Properly discard this product||
7225|154|R|when it is expired or no longer needed. Consult your pharmacist||
7225|155|R|or local waste disposal company.||
7225|156|B|||
7225|157|A|Information last revised July 2025.||
7225|158|A|Copyright(c) 2025 First Databank, Inc.||
7225|159|B|||
7226|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7226|002|Z|does NOT have all possible information about this product. This||
7226|003|Z|information does not assure that this product is safe, effective,||
7226|004|Z|or appropriate for you. This information is not individual||
7226|005|Z|medical advice and does not substitute for the advice of your||
7226|006|Z|health care professional. Always ask your health care||
7226|007|Z|professional for complete information about this product and your||
7226|008|Z|specific health needs.||
7226|009|B|||
7226|010|T|COAL TAR SHAMPOO - TOPICAL||
7226|011|F|(kole tar)||
7226|012|B|||
7226|013|C|COMMON BRAND NAME(S): Denorex, Pentrax, Zetar||
7226|014|B|||
7226|015|U|USES:  This medication is used on the hair/scalp to treat||
7226|016|U|dandruff and other scaly, itchy skin conditions (psoriasis or||
7226|017|U|seborrheic dermatitis). Coal tar belongs to a class of drugs||
7226|018|U|known as keratoplastics. It works by causing the skin to shed||
7226|019|U|dead cells from its top layer and slow down the growth of skin||
7226|020|U|cells. This effect decreases scaling and dryness. Coal tar can||
7226|021|U|also decrease itchiness from these skin conditions.||
7226|022|B|||
7226|023|V|OTHER USES:  This section contains uses of this product that are||
7226|024|V|not listed in the approved professional labeling for the product||
7226|025|V|but that may be prescribed by your health care professional. Use||
7226|026|V|this product for a condition that is listed in this section only||
7226|027|V|if it has been so prescribed by your health care professional.||
7226|028|V|   This product may also be used for other types of rashes (such||
7226|029|V|as eczema, atopic dermatitis, chronic exudative dermatitis).||
7226|030|B|||
7226|031|H|HOW TO USE:  Follow all directions on the product package. If you||
7226|032|H|have any questions, ask your doctor or pharmacist.||
7226|033|H|   This medication is for use on the hair and scalp only. To||
7226|034|H|avoid irritation, do not let this medication come into contact||
7226|035|H|with your eyes, nose, mouth, groin, or rectum. If you do get the||
7226|036|H|medication in those areas, flush the area with cool water for 15||
7226|037|H|minutes. Wash hands after use. Do not apply to broken or infected||
7226|038|H|skin unless directed by your doctor.||
7226|039|H|   Wet hair/scalp thoroughly. Apply a generous amount of coal tar||
7226|040|H|shampoo and massage into a lather. Allow lather to remain on||
7226|041|H|scalp for several minutes. Rinse thoroughly and repeat. To help||
7226|042|H|keep this product out of your eyes, keep eyes closed while||
7226|043|H|shampooing. Protect eyes with a washcloth or towel.||
7226|044|H|   Use this product usually twice a week or as directed by your||
7226|045|H|doctor. The dosage is based on your medical condition, your||
7226|046|H|product type/brand, and response to treatment. Do not use large||
7226|047|H|amounts of this medication, use it more often, or use it for a||
7226|048|H|longer period than directed. Your condition will not clear||
7226|049|H|faster, but the chance for side effects may be increased.||
7226|050|H|   If your skin condition lasts or gets worse, if it covers a||
7226|051|H|large area of skin, or if you think you may have a serious||
7226|052|H|medical problem, get medical help right away.||
7226|053|B|||
7226|054|S|SIDE EFFECTS:  Skin/scalp irritation or staining of skin/hair||
7226|055|S|(especially in patients with blonde, bleached, dyed, or gray||
7226|056|S|hair) may occur. If skin irritation develops or worsens, stop||
7226|057|S|using this product and tell your doctor or pharmacist promptly.||
7226|058|S|   If your doctor has directed you to use this medication,||
7226|059|S|remember that your doctor has judged that the benefit to you is||
7226|060|S|greater than the risk of side effects. Many people using this||
7226|061|S|medication do not have serious side effects.||
7226|062|S|   Long-term use of this product can cause hair follicle problems||
7226|063|S|(tar acne). Contact your doctor if you notice new skin bumps||
7226|064|S|and/or acne in the treated area.||
7226|065|S|   A very serious allergic reaction to this drug is rare.||
7226|066|S|However, get medical help right away if you notice any symptoms||
7226|067|S|of a serious allergic reaction, including: rash, itching/swelling||
7226|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7226|069|S|breathing.||
7226|070|S|   This is not a complete list of possible side effects. If you||
7226|071|S|notice other effects not listed above, contact your doctor or||
7226|072|S|pharmacist.||
7226|073|S|   In the US -||
7226|074|S|   Call your doctor for medical advice about side effects. You||
7226|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7226|076|S|www.fda.gov/medwatch.||
7226|077|S|   In Canada - Call your doctor for medical advice about side||
7226|078|S|effects. You may report side effects to Health Canada at||
7226|079|S|1-866-234-2345.||
7226|080|B|||
7226|081|P|PRECAUTIONS:  Before using coal tar shampoo, tell your doctor or||
7226|082|P|pharmacist if you are allergic to it; or if you have any other||
7226|083|P|allergies. This product may contain inactive ingredients, which||
7226|084|P|can cause allergic reactions or other problems. Talk to your||
7226|085|P|pharmacist for more details.||
7226|086|P|   Before using this medication, tell your doctor or pharmacist||
7226|087|P|your medical history.||
7226|088|P|   This medication may make you more sensitive to the sun. Be||
7226|089|P|sure to completely wash off the medication before going out into||
7226|090|P|the sun. Avoid sun exposure, tanning booths, and sunlamps for at||
7226|091|P|least 24 hours after using this medication unless your doctor||
7226|092|P|directs you otherwise. Other medications may also increase your||
7226|093|P|sun sensitivity. Ask your doctor or pharmacist for more details.||
7226|094|P|Tell your doctor right away if you get sunburned or have skin||
7226|095|P|blisters/redness.||
7226|096|P|   Before having surgery, tell your doctor or dentist about all||
7226|097|P|the products you use (including prescription drugs,||
7226|098|P|nonprescription drugs, and herbal products).||
7226|099|P|   During pregnancy, this medication should be used only when||
7226|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
7226|101|P|   It is unknown if this drug passes into breast milk. Consult||
7226|102|P|your doctor before breastfeeding.||
7226|103|B|||
7226|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7226|105|I|medications work or increase your risk for serious side effects.||
7226|106|I|This document does not contain all possible drug interactions.||
7226|107|I|Keep a list of all the products you use (including||
7226|108|I|prescription/nonprescription drugs and herbal products) and share||
7226|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
7226|110|I|the dosage of any medicines without your doctor's approval.||
7226|111|B|||
7226|112|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7226|113|O|has overdosed and has serious symptoms such as passing out or||
7226|114|O|trouble breathing, call 911. Otherwise, call a poison control||
7226|115|O|center right away. US residents can call 1-800-222-1222. Canada||
7226|116|O|residents can call 1-844-764-7669.||
7226|117|B|||
7226|118|N|NOTES:  This product may stain clothing. Avoid allowing this||
7226|119|N|medication to touch clothing.||
7226|120|N|   If your doctor has prescribed this medication for you, do not||
7226|121|N|share it with others.||
7226|122|B|||
7226|123|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7226|124|D|If it is near the time of the next dose, skip the missed dose.||
7226|125|D|Use your next dose at the regular time. Do not double the dose to||
7226|126|D|catch up.||
7226|127|B|||
7226|128|R|STORAGE:  Store at room temperature. Different brands of this||
7226|129|R|medication may have different storage requirements. Refer to the||
7226|130|R|package labeling or ask your pharmacist for the storage||
7226|131|R|requirements for the brand you are using. Keep all medications||
7226|132|R|away from children and pets.||
7226|133|R|   Do not flush medications down the toilet or pour them into a||
7226|134|R|drain unless instructed to do so. Properly discard this product||
7226|135|R|when it is expired or no longer needed. Consult your pharmacist||
7226|136|R|or local waste disposal company.||
7226|137|B|||
7226|138|A|Information last revised November 2025.||
7226|139|A|Copyright(c) 2025 First Databank, Inc.||
7226|140|B|||
7227|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7227|002|Z|does NOT have all possible information about this product. This||
7227|003|Z|information does not assure that this product is safe, effective,||
7227|004|Z|or appropriate for you. This information is not individual||
7227|005|Z|medical advice and does not substitute for the advice of your||
7227|006|Z|health care professional. Always ask your health care||
7227|007|Z|professional for complete information about this product and your||
7227|008|Z|specific health needs.||
7227|009|B|||
7227|010|T|POTASSIUM CITRATE TABLET - ORAL||
7227|011|F|(poh-TASS-ee-um SYE-trate)||
7227|012|B|||
7227|013|C|COMMON BRAND NAME(S): Urocit-K||
7227|014|B|||
7227|015|U|USES:  This medication is used to make the urine less acidic.||
7227|016|U|This effect helps the kidneys get rid of uric acid, thereby||
7227|017|U|helping to prevent gout and kidney stones. This medication can||
7227|018|U|also prevent and treat certain metabolic problems (acidosis)||
7227|019|U|caused by kidney disease.||
7227|020|U|   Citric acid and citrate salts (which contain potassium and||
7227|021|U|sodium) belong to a class of drugs known as urinary alkalinizers.||
7227|022|U|If you have a condition that requires you to limit your intake of||
7227|023|U|potassium and sodium, your doctor may direct you to take a||
7227|024|U|product that is lower in potassium and sodium.||
7227|025|B|||
7227|026|H|HOW TO USE:  Take this medication by mouth as directed by your||
7227|027|H|doctor. Follow your doctor's directions carefully. This||
7227|028|H|medication should be taken with meals or a bedtime snack.||
7227|029|H|   Swallow this medication with a full glass of water or other||
7227|030|H|liquid (8 ounces or 240 milliliters) unless your doctor directs||
7227|031|H|you otherwise. Swallow the tablets whole. Do not crush or chew||
7227|032|H|the tablets. Doing so can release all of the drug at once,||
7227|033|H|increasing the risk of side effects. Do not lie down for at least||
7227|034|H|10 minutes after taking this medication. Do not take this||
7227|035|H|medication on an empty stomach.||
7227|036|H|   Your doctor may direct you to eat a low-salt (low-sodium) diet||
7227|037|H|and drink lots of fluids. Follow your doctor's directions||
7227|038|H|closely. Do not use salt substitutes that contain potassium.||
7227|039|H|   Dosage is based on your medical condition and response to||
7227|040|H|treatment.||
7227|041|H|   Take this medication exactly as prescribed. Do not increase||
7227|042|H|your dose or take this more often without your doctor's approval.||
7227|043|H|Use this medication regularly to get the most benefit from it. To||
7227|044|H|help you remember, take it at the same times each day.||
7227|045|H|   While taking this medication, you may need to test the pH||
7227|046|H|(acidity) of your urine using special paper. The pH will help||
7227|047|H|determine the proper dose. Consult your doctor or pharmacist for||
7227|048|H|more information.||
7227|049|B|||
7227|050|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, and stomach pain may||
7227|051|S|occur. Taking it after meals will help prevent these side||
7227|052|S|effects. If any of these effects last or get worse, tell your||
7227|053|S|doctor or pharmacist promptly.||
7227|054|S|   An empty tablet shell may appear in your stool. This is||
7227|055|S|harmless because your body has already absorbed the medication.||
7227|056|S|   Remember that this medication has been prescribed because your||
7227|057|S|doctor has judged that the benefit to you is greater than the||
7227|058|S|risk of side effects. Many people using this medication do not||
7227|059|S|have serious side effects.||
7227|060|S|   This drug may cause serious stomach or intestinal problems||
7227|061|S|(such as bleeding, blockage, puncture). Tell your doctor right||
7227|062|S|away if any of these serious side effects occur: abdominal||
7227|063|S|swelling, black/bloody stools, constipation, dizziness, fast||
7227|064|S|heartbeat, severe stomach/abdominal pain, difficult/painful||
7227|065|S|swallowing, severe vomiting, vomit that looks like coffee||
7227|066|S|grounds.||
7227|067|S|   This medication may cause high potassium levels in the blood||
7227|068|S|(hyperkalemia). Tell your doctor right away if any of these||
7227|069|S|serious side effects occur: muscle cramps/weakness, severe||
7227|070|S|dizziness, slow/irregular heartbeat, mental/mood changes (such as||
7227|071|S|confusion, restlessness), tingling of the hands/feet, unusually||
7227|072|S|cold skin.||
7227|073|S|   A very serious allergic reaction to this drug is rare.||
7227|074|S|However, get medical help right away if you notice any symptoms||
7227|075|S|of a serious allergic reaction, including: rash, itching/swelling||
7227|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7227|077|S|breathing.||
7227|078|S|   This is not a complete list of possible side effects. If you||
7227|079|S|notice other effects not listed above, contact your doctor or||
7227|080|S|pharmacist.||
7227|081|S|   In the US -||
7227|082|S|   Call your doctor for medical advice about side effects. You||
7227|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7227|084|S|www.fda.gov/medwatch.||
7227|085|S|   In Canada - Call your doctor for medical advice about side||
7227|086|S|effects. You may report side effects to Health Canada at||
7227|087|S|1-866-234-2345.||
7227|088|B|||
7227|089|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
7227|090|P|pharmacist if you are allergic to it; or if you have any other||
7227|091|P|allergies. This product may contain inactive ingredients, which||
7227|092|P|can cause allergic reactions or other problems. Talk to your||
7227|093|P|pharmacist for more details.||
7227|094|P|   Before using this medication, tell your doctor or pharmacist||
7227|095|P|your medical history, especially of: a certain adrenal gland||
7227|096|P|problem (Addison's disease), bladder infection, diabetes, low||
7227|097|P|calcium levels, severe diarrhea, heart problems (such as||
7227|098|P|irregular heartbeat, heart attack), kidney problems,||
7227|099|P|potassium-restricted diet, high potassium levels,||
7227|100|P|stomach/intestinal problems (such as blockage, constipation,||
7227|101|P|ulcers), dehydration.||
7227|102|P|   Before having surgery, tell your doctor or dentist about all||
7227|103|P|the products you use (including prescription drugs,||
7227|104|P|nonprescription drugs, and herbal products).||
7227|105|P|   During pregnancy, this medication should be used only when||
7227|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
7227|107|P|   It is unknown if this drug passes into breast milk. Consult||
7227|108|P|your doctor before breastfeeding.||
7227|109|B|||
7227|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7227|111|I|medications work or increase your risk for serious side effects.||
7227|112|I|This document does not contain all possible drug interactions.||
7227|113|I|Keep a list of all the products you use (including||
7227|114|I|prescription/nonprescription drugs and herbal products) and share||
7227|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
7227|116|I|the dosage of any medicines without your doctor's approval.||
7227|117|I|   Some products that may interact with this drug include:||
7227|118|I|antacids that contain aluminum, aspirin and other salicylates||
7227|119|I|(such as salsalate), certain blood pressure medications||
7227|120|I|(including ACE inhibitors such as lisinopril, angiotensin||
7227|121|I|blockers such as losartan), drospirenone, drugs that slow the||
7227|122|I|movement of food/drugs through the esophagus/stomach (including||
7227|123|I|anticholinergics such as belladonna/scopolamine/benztropine,||
7227|124|I|antispasmodics such as glycopyrrolate/oxybutynin, strong opioid||
7227|125|I|pain medicines such as morphine), eplerenone, certain heart||
7227|126|I|medications (such as quinidine, digoxin), lithium, potassium||
7227|127|I|supplements (including salt substitutes), pramlintide, certain||
7227|128|I|"water pills" (potassium-sparing diuretics such as amiloride,||
7227|129|I|spironolactone, triamterene).||
7227|130|I|   If your doctor has told you to take low-dose aspirin to||
7227|131|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
7227|132|I|you should keep taking the aspirin unless your doctor tells you||
7227|133|I|not to. Ask your doctor or pharmacist for more details.||
7227|134|B|||
7227|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7227|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7227|137|O|poison control center right away. US residents can call||
7227|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7227|139|O|Symptoms of overdose may include: slow heartbeat, heart attack,||
7227|140|O|inability to move.||
7227|141|B|||
7227|142|N|NOTES:  Do not share this medication with others.||
7227|143|N|   Lab and/or medical tests (such as complete blood count,||
7227|144|N|potassium/sodium/chloride levels, kidney function) should be done||
7227|145|N|while you are taking this medication. Keep all medical and lab||
7227|146|N|appointments. Consult your doctor for more details.||
7227|147|B|||
7227|148|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7227|149|D|remember. If it is near the time of the next dose, skip the||
7227|150|D|missed dose. Take your next dose at the regular time. Do not||
7227|151|D|double the dose to catch up.||
7227|152|B|||
7227|153|R|STORAGE:  Store at room temperature away from light and moisture.||
7227|154|R|Do not store in the bathroom. Keep all medications away from||
7227|155|R|children and pets.||
7227|156|R|   Do not flush medications down the toilet or pour them into a||
7227|157|R|drain unless instructed to do so. Properly discard this product||
7227|158|R|when it is expired or no longer needed. Consult your pharmacist||
7227|159|R|or local waste disposal company.||
7227|160|B|||
7227|161|A|Information last revised May 2024.||
7227|162|A|Copyright(c) 2025 First Databank, Inc.||
7227|163|B|||
7240|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7240|002|Z|does NOT have all possible information about this product. This||
7240|003|Z|information does not assure that this product is safe, effective,||
7240|004|Z|or appropriate for you. This information is not individual||
7240|005|Z|medical advice and does not substitute for the advice of your||
7240|006|Z|health care professional. Always ask your health care||
7240|007|Z|professional for complete information about this product and your||
7240|008|Z|specific health needs.||
7240|009|B|||
7240|010|T|AMOXICILLIN/CLAVULANIC ACID CHEWABLE TABLET - ORAL||
7240|011|F|(a-MOX-i-SIL-in/KLAV-ue-LAN-ik AS-id)||
7240|012|B|||
7240|013|C|COMMON BRAND NAME(S): Augmentin||
7240|014|B|||
7240|015|U|USES:  Amoxicillin/clavulanic acid is a combination||
7240|016|U|penicillin-type antibiotic used to treat a wide variety of||
7240|017|U|bacterial infections. It works by stopping the growth of||
7240|018|U|bacteria.||
7240|019|U|   This antibiotic treats only bacterial infections. It will not||
7240|020|U|work for viral infections (such as common cold, flu). Using any||
7240|021|U|antibiotic when it is not needed can cause it to not work for||
7240|022|U|future infections.||
7240|023|B|||
7240|024|H|HOW TO USE:  Chew the tablets thoroughly and swallow, followed by||
7240|025|H|a full glass of water (8 ounces/240 milliliters). Take this||
7240|026|H|medication with a meal or snack as directed by the doctor.||
7240|027|H|Depending on your specific product, this medication is usually||
7240|028|H|taken every 8 or 12 hours.||
7240|029|H|   The dosage is based on your weight, medical condition, and||
7240|030|H|response to treatment.||
7240|031|H|   For the best effect, take this antibiotic at evenly spaced||
7240|032|H|times. To help you remember, take this medication at the same||
7240|033|H|time(s) every day.||
7240|034|H|   Continue to take this medication until the full prescribed||
7240|035|H|amount is finished, even if symptoms disappear after a few days.||
7240|036|H|Stopping the medication too early may result in a return of the||
7240|037|H|infection.||
7240|038|H|   Tell the doctor if your condition lasts or gets worse.||
7240|039|B|||
7240|040|S|SIDE EFFECTS:  Diarrhea, nausea, or vomiting may occur. If any of||
7240|041|S|these effects last or get worse, tell the doctor or pharmacist||
7240|042|S|promptly. Taking this medication with food will help to reduce||
7240|043|S|stomach upset.||
7240|044|S|   Remember that this medication has been prescribed because your||
7240|045|S|doctor has judged that the benefit to you is greater than the||
7240|046|S|risk of side effects. Many people using this medication do not||
7240|047|S|have serious side effects.||
7240|048|S|   Tell your doctor right away if you have any serious side||
7240|049|S|effects, including: signs of liver disease (such as||
7240|050|S|nausea/vomiting that doesn't stop, loss of appetite,||
7240|051|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
7240|052|S|bruising/bleeding, unusual tiredness.||
7240|053|S|   This medication may rarely cause a severe intestinal condition||
7240|054|S|due to a bacteria called C. difficile. This condition may occur||
7240|055|S|during treatment or weeks to months after treatment has stopped.||
7240|056|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7240|057|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7240|058|S|stool.||
7240|059|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7240|060|S|products because they may make symptoms worse.||
7240|061|S|   Use of this medication for prolonged or repeated periods may||
7240|062|S|result in oral thrush or a new yeast infection. Contact the||
7240|063|S|doctor if you notice white patches in your mouth, a change in||
7240|064|S|vaginal discharge or other new symptoms.||
7240|065|S|   A very serious allergic reaction to this drug is rare.||
7240|066|S|However, get medical help right away if you notice any symptoms||
7240|067|S|of a serious allergic reaction, including: fever that doesn't go||
7240|068|S|away, new or worsening lymph node swelling, rash,||
7240|069|S|itching/swelling (especially of the face/tongue/throat), severe||
7240|070|S|dizziness, trouble breathing.||
7240|071|S|   Amoxicillin can commonly cause a mild rash that is usually not||
7240|072|S|serious. However, you may not be able to tell it apart from a||
7240|073|S|rare rash that could be a sign of a severe allergic reaction. Get||
7240|074|S|medical help right away if you develop any rash.||
7240|075|S|   This is not a complete list of possible side effects. If you||
7240|076|S|notice other effects not listed above, contact the doctor or||
7240|077|S|pharmacist.||
7240|078|S|   In the US -||
7240|079|S|   Call your doctor for medical advice about side effects. You||
7240|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7240|081|S|www.fda.gov/medwatch.||
7240|082|S|   In Canada - Call your doctor for medical advice about side||
7240|083|S|effects. You may report side effects to Health Canada at||
7240|084|S|1-866-234-2345.||
7240|085|B|||
7240|086|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
7240|087|P|pharmacist if you are allergic to amoxicillin or clavulanic acid;||
7240|088|P|or to penicillin or cephalosporin antibiotics; or if you have any||
7240|089|P|other allergies. This product may contain inactive ingredients,||
7240|090|P|which can cause allergic reactions or other problems. Talk to||
7240|091|P|your pharmacist for more details.||
7240|092|P|   Before using this medication, tell the doctor or pharmacist||
7240|093|P|your medical history, especially of: liver disease (including||
7240|094|P|liver problems caused by previous use of amoxicillin/clavulanic||
7240|095|P|acid), kidney disease, a certain type of viral infection||
7240|096|P|(infectious mononucleosis).||
7240|097|P|   This medication may contain aspartame. If you have||
7240|098|P|phenylketonuria (PKU) or any other condition that requires you to||
7240|099|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
7240|100|P|doctor or pharmacist about using this medication safely.||
7240|101|P|   Before having surgery, tell your doctor or dentist about all||
7240|102|P|the products you use (including prescription drugs,||
7240|103|P|nonprescription drugs, and herbal products).||
7240|104|P|   This product may cause live bacterial vaccines (such as||
7240|105|P|typhoid vaccine) to not work well. Tell your health care||
7240|106|P|professional that you are using this medication before having any||
7240|107|P|immunizations/vaccinations.||
7240|108|P|   During pregnancy, this medication should be used only when||
7240|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
7240|110|P|   This medication passes into breast milk. Consult your doctor||
7240|111|P|before breastfeeding.||
7240|112|B|||
7240|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7240|114|I|medications work or increase your risk for serious side effects.||
7240|115|I|This document does not contain all possible drug interactions.||
7240|116|I|Keep a list of all the products you use (including||
7240|117|I|prescription/nonprescription drugs and herbal products) and share||
7240|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
7240|119|I|the dosage of any medicines without your doctor's approval.||
7240|120|I|   A product that may interact with this drug is: methotrexate.||
7240|121|I|   This medication may interfere with certain lab tests (such as||
7240|122|I|certain urine glucose tests), possibly causing false test||
7240|123|I|results. Make sure lab personnel and all your doctors know you||
7240|124|I|use this drug.||
7240|125|B|||
7240|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7240|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7240|128|O|poison control center right away. US residents can call||
7240|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7240|130|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
7240|131|O|severe vomiting, change in the amount of urine.||
7240|132|B|||
7240|133|N|NOTES:  Do not share this medication with others.||
7240|134|N|   This medication has been prescribed for your current condition||
7240|135|N|only. Do not use it later for another infection unless your||
7240|136|N|doctor tells you to.||
7240|137|N|   With long-term treatment, lab and/or medical tests (such as||
7240|138|N|kidney/liver function, complete blood counts) may be done while||
7240|139|N|you are taking this medication. Keep all medical and lab||
7240|140|N|appointments. Consult your doctor for more details.||
7240|141|B|||
7240|142|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7240|143|D|remember. If it is near the time of the next dose, skip the||
7240|144|D|missed dose. Take your next dose at the regular time. Do not||
7240|145|D|double the dose to catch up.||
7240|146|B|||
7240|147|R|STORAGE:  Store at room temperature away from light and moisture.||
7240|148|R|Do not store in the bathroom. Keep all medications away from||
7240|149|R|children and pets.||
7240|150|R|   Do not flush medications down the toilet or pour them into a||
7240|151|R|drain unless instructed to do so. Properly discard this product||
7240|152|R|when it is expired or no longer needed. Consult your pharmacist||
7240|153|R|or local waste disposal company.||
7240|154|B|||
7240|155|A|Information last revised May 2024.||
7240|156|A|Copyright(c) 2025 First Databank, Inc.||
7240|157|B|||
7244|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7244|002|Z|does NOT have all possible information about this product. This||
7244|003|Z|information does not assure that this product is safe, effective,||
7244|004|Z|or appropriate for you. This information is not individual||
7244|005|Z|medical advice and does not substitute for the advice of your||
7244|006|Z|health care professional. Always ask your health care||
7244|007|Z|professional for complete information about this product and your||
7244|008|Z|specific health needs.||
7244|009|B|||
7244|010|T|ALPRAZOLAM - ORAL||
7244|011|F|(al-PRA-zoe-lam)||
7244|012|B|||
7244|013|C|COMMON BRAND NAME(S): Xanax||
7244|014|B|||
7244|015|W|WARNING:  Alprazolam has a risk for abuse and addiction, which||
7244|016|W|can lead to overdose and death. Taking this medication with||
7244|017|W|alcohol or other drugs that can cause drowsiness or breathing||
7244|018|W|problems (especially opioid medications such as codeine,||
7244|019|W|hydrocodone) may cause very serious side effects, including||
7244|020|W|death. To lower your risk, your doctor should have you take the||
7244|021|W|smallest dose of alprazolam that works, and take it for the||
7244|022|W|shortest possible time. Be sure you know how to take alprazolam||
7244|023|W|and what other drugs you should avoid taking with it. See also||
7244|024|W|Drug Interactions section. Get medical help right away if any of||
7244|025|W|these very serious side effects occur: slow/shallow breathing,||
7244|026|W|unusual lightheadedness, severe drowsiness/dizziness, difficulty||
7244|027|W|waking up.||
7244|028|W|   Suddenly stopping this medication may cause serious (possibly||
7244|029|W|fatal) withdrawal, especially if you have used it for a long time||
7244|030|W|or in high doses. To prevent withdrawal, your doctor may lower||
7244|031|W|your dose slowly. Tell your doctor or pharmacist right away if||
7244|032|W|you have any withdrawal symptoms such as headaches, trouble||
7244|033|W|sleeping, restlessness, hallucinations/confusion, depression,||
7244|034|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
7244|035|W|to months.||
7244|036|B|||
7244|037|U|USES:  Alprazolam is used to treat anxiety and panic disorders.||
7244|038|U|It belongs to a class of medications called benzodiazepines which||
7244|039|U|act on the brain and nerves (central nervous system) to produce a||
7244|040|U|calming effect. It works by enhancing the effects of a certain||
7244|041|U|natural chemical in the body (GABA).||
7244|042|B|||
7244|043|H|HOW TO USE:  See also Warning section.||
7244|044|H|   Read the Medication Guide provided by your pharmacist before||
7244|045|H|you start taking alprazolam and each time you get a refill. If||
7244|046|H|you have any questions, ask your doctor or pharmacist.||
7244|047|H|   Take this medication by mouth as directed by your doctor. The||
7244|048|H|dosage is based on your medical condition, age, and response to||
7244|049|H|treatment. Your dose may be gradually increased until the drug||
7244|050|H|starts working well. Follow your doctor's instructions closely to||
7244|051|H|reduce the risk of side effects.||
7244|052|H|   Though it helps many people, this medication may sometimes||
7244|053|H|cause addiction. This risk may be higher if you have a substance||
7244|054|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
7244|055|H|Take this medication exactly as prescribed to lower the risk of||
7244|056|H|addiction. Ask your doctor or pharmacist for more details.||
7244|057|H|   When this medication is used for a long time, it may not work||
7244|058|H|as well. Talk with your doctor if this medication stops working||
7244|059|H|well.||
7244|060|H|   Tell your doctor if your condition lasts or gets worse.||
7244|061|B|||
7244|062|S|SIDE EFFECTS:  See also Warning section.||
7244|063|S|   Drowsiness, dizziness, increased saliva production, or change||
7244|064|S|in sex drive/ability may occur. If any of these effects last or||
7244|065|S|get worse, tell your doctor or pharmacist promptly.||
7244|066|S|   To reduce the risk of dizziness and lightheadedness, get up||
7244|067|S|slowly when rising from a sitting or lying position.||
7244|068|S|   Remember that this medication has been prescribed because your||
7244|069|S|doctor has judged that the benefit to you is greater than the||
7244|070|S|risk of side effects. Many people using this medication do not||
7244|071|S|have serious side effects.||
7244|072|S|   Tell your doctor right away if you have any serious side||
7244|073|S|effects, including: mental/mood changes (such as hallucinations,||
7244|074|S|thoughts of suicide), trouble speaking, loss of coordination,||
7244|075|S|trouble walking, memory problems.||
7244|076|S|   Get medical help right away if you have any very serious side||
7244|077|S|effects, including: yellowing eyes/skin, seizures.||
7244|078|S|   A very serious allergic reaction to this drug is rare.||
7244|079|S|However, get medical help right away if you notice any symptoms||
7244|080|S|of a serious allergic reaction, including: rash, itching/swelling||
7244|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7244|082|S|breathing.||
7244|083|S|   This is not a complete list of possible side effects. If you||
7244|084|S|notice other effects not listed above, contact your doctor or||
7244|085|S|pharmacist.||
7244|086|S|   In the US -||
7244|087|S|   Call your doctor for medical advice about side effects. You||
7244|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7244|089|S|www.fda.gov/medwatch.||
7244|090|S|   In Canada - Call your doctor for medical advice about side||
7244|091|S|effects. You may report side effects to Health Canada at||
7244|092|S|1-866-234-2345.||
7244|093|B|||
7244|094|P|PRECAUTIONS:  Before taking alprazolam, tell your doctor or||
7244|095|P|pharmacist if you are allergic to it; or to other benzodiazepines||
7244|096|P|(such as diazepam, lorazepam); or if you have any other||
7244|097|P|allergies. This product may contain inactive ingredients, which||
7244|098|P|can cause allergic reactions or other problems. Talk to your||
7244|099|P|pharmacist for more details.||
7244|100|P|   Before using this medication, tell your doctor or pharmacist||
7244|101|P|your medical history, especially of: lung/breathing problems||
7244|102|P|(such as COPD, sleep apnea), liver disease, kidney disease,||
7244|103|P|personal or family history of a substance use disorder (such as||
7244|104|P|overuse of or addiction to drugs/alcohol), glaucoma.||
7244|105|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7244|106|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7244|107|P|machinery, or do anything that needs alertness until you can do||
7244|108|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
7244|109|P|are using marijuana (cannabis).||
7244|110|P|   Before having surgery, tell your doctor or dentist about all||
7244|111|P|the products you use (including prescription drugs,||
7244|112|P|nonprescription drugs, and herbal products).||
7244|113|P|   Older adults may be more sensitive to the side effects of this||
7244|114|P|drug, especially loss of coordination and drowsiness. These side||
7244|115|P|effects can increase the risk of falling.||
7244|116|P|   Tell your doctor if you are pregnant or plan to become||
7244|117|P|pregnant. You should not become pregnant while using alprazolam.||
7244|118|P|Alprazolam may harm an unborn baby. Newborn babies of mothers who||
7244|119|P|use this medication late in pregnancy may have symptoms such as||
7244|120|P|slow/shallow breathing, nonstop crying, shaking, or trouble||
7244|121|P|feeding. If you become pregnant, talk to your doctor right away||
7244|122|P|about the risks and benefits of this medication.||
7244|123|P|   This drug passes into breast milk and may have undesirable||
7244|124|P|effects on a nursing infant. Breastfeeding is not recommended||
7244|125|P|while using this drug. Consult your doctor before breastfeeding.||
7244|126|B|||
7244|127|I|DRUG INTERACTIONS:  See also Warning section.||
7244|128|I|   Drug interactions may change how your medications work or||
7244|129|I|increase your risk for serious side effects. This document does||
7244|130|I|not contain all possible drug interactions. Keep a list of all||
7244|131|I|the products you use (including prescription/nonprescription||
7244|132|I|drugs and herbal products) and share it with your doctor and||
7244|133|I|pharmacist. Do not start, stop, or change the dosage of any||
7244|134|I|medicines without your doctor's approval.||
7244|135|I|   Some products that may interact with this drug include: kava,||
7244|136|I|sodium oxybate.||
7244|137|I|   Other medications can affect the removal of alprazolam from||
7244|138|I|your body, which may affect how alprazolam works. Examples||
7244|139|I|include adagrasib, azole antifungals (such as itraconazole,||
7244|140|I|ketoconazole), cimetidine, certain anti-depressants (such as||
7244|141|I|fluoxetine, fluvoxamine, nefazodone), macrolide antibiotics (such||
7244|142|I|as erythromycin), rifamycins (such as rifabutin), St. John's||
7244|143|I|wort, drugs used to treat seizures (such as phenytoin), among||
7244|144|I|others.||
7244|145|I|   The risk of serious side effects (such as slow/shallow||
7244|146|I|breathing, severe drowsiness/dizziness) may be increased if this||
7244|147|I|medication is taken with other products that may also cause||
7244|148|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
7244|149|I|if you are taking other products such as opioid pain or cough||
7244|150|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7244|151|I|(cannabis), other drugs for sleep or anxiety (such as diazepam,||
7244|152|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7244|153|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7244|154|I|diphenhydramine).||
7244|155|I|   Check the labels on all your medicines (such as allergy or||
7244|156|I|cough-and-cold products) because they may contain ingredients||
7244|157|I|that cause drowsiness. Ask your pharmacist about using those||
7244|158|I|products safely.||
7244|159|I|   Cigarette smoking decreases blood levels of this medication.||
7244|160|I|Tell your doctor if you smoke or if you have recently stopped||
7244|161|I|smoking.||
7244|162|B|||
7244|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7244|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7244|165|O|poison control center right away. US residents can call||
7244|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7244|167|O|Symptoms of overdose may include: severe drowsiness,||
7244|168|O|slowed/reduced reflexes, slowed breathing, loss of consciousness.||
7244|169|B|||
7244|170|N|NOTES:  Do not share this medication with others. Sharing it is||
7244|171|N|against the law.||
7244|172|N|   Lab and/or medical tests (such as liver function) should be||
7244|173|N|done while you are taking this medication. Keep all medical and||
7244|174|N|lab appointments. Consult your doctor for more details.||
7244|175|B|||
7244|176|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7244|177|D|remember. If it is near the time of the next dose, skip the||
7244|178|D|missed dose. Take your next dose at the regular time. Do not||
7244|179|D|double the dose to catch up.||
7244|180|B|||
7244|181|R|STORAGE:  Store at room temperature away from light and moisture.||
7244|182|R|Do not store in the bathroom. Keep all medications away from||
7244|183|R|children and pets.||
7244|184|R|   Do not flush medications down the toilet or pour them into a||
7244|185|R|drain unless instructed to do so. Properly discard this product||
7244|186|R|when it is expired or no longer needed. Consult your pharmacist||
7244|187|R|or local waste disposal company.||
7244|188|B|||
7244|189|A|Information last revised April 2025.||
7244|190|A|Copyright(c) 2025 First Databank, Inc.||
7244|191|B|||
7246|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7246|002|Z|does NOT have all possible information about this product. This||
7246|003|Z|information does not assure that this product is safe, effective,||
7246|004|Z|or appropriate for you. This information is not individual||
7246|005|Z|medical advice and does not substitute for the advice of your||
7246|006|Z|health care professional. Always ask your health care||
7246|007|Z|professional for complete information about this product and your||
7246|008|Z|specific health needs.||
7246|009|B|||
7246|010|T|FACTOR IX, RECOMBINANT - INJECTION||
7246|011|F|(FACK-ter nine)||
7246|012|B|||
7246|013|C|COMMON BRAND NAME(S): Alprolix, Benefix, Ixinity||
7246|014|B|||
7246|015|U|USES:  This medication is used to prevent or control bleeding in||
7246|016|U|people with little or no factor IX (due to hemophilia B,||
7246|017|U|Christmas disease). Factor IX is a protein (clotting factor) in||
7246|018|U|the blood that works with other clotting factors to help the||
7246|019|U|blood clot and stop bleeding. People with little or no factor IX||
7246|020|U|are at risk for bleeding longer after an injury/surgery or||
7246|021|U|bleeding suddenly (often in the joints/muscle) without an obvious||
7246|022|U|cause.||
7246|023|U|   This medication should not be used to treat other types of||
7246|024|U|factor deficiencies (such as factors II, VII, VIII, X) or factor||
7246|025|U|problems (such as inhibitor to factor XIII), to reverse the||
7246|026|U|effects of "blood thinners" (such as warfarin), or to treat||
7246|027|U|bleeding from low levels of liver-dependent clotting factors (due||
7246|028|U|to liver problems).||
7246|029|B|||
7246|030|H|HOW TO USE:  Read the Patient Information Leaflet and||
7246|031|H|Instructions for Use if available from your pharmacist before you||
7246|032|H|start using factor IX and each time you get a refill. If you have||
7246|033|H|any questions, ask your doctor or pharmacist.||
7246|034|H|   This medication is given by injection into a vein over several||
7246|035|H|minutes as directed by your doctor. The dosage is based on your||
7246|036|H|medical condition, age, weight, and response to treatment.||
7246|037|H|   If you are giving this medication to yourself at home, learn||
7246|038|H|all preparation and usage instructions from your health care||
7246|039|H|professional. Before using, check this product for particles or||
7246|040|H|discoloration. If either is present, do not use the liquid. Learn||
7246|041|H|how to store and discard medical supplies safely.||
7246|042|H|   The medication in the vial and the supplies that come with the||
7246|043|H|medication should be used only once. Do not reuse.||
7246|044|H|   For some brands, it is important to limit the amount of blood||
7246|045|H|entering the tubing and to avoid letting any blood enter the||
7246|046|H|syringe. You may need to use a new vial of medication and new set||
7246|047|H|of supplies if this occurs. Consult your pharmacist for details.||
7246|048|H|   Tell your doctor if your condition lasts or gets worse.||
7246|049|B|||
7246|050|S|SIDE EFFECTS:  Fever, pain at injection site, chills, headache,||
7246|051|S|flushing, weakness, nausea, or vomiting may occur. If any of||
7246|052|S|these effects last or get worse, tell your doctor or pharmacist||
7246|053|S|promptly.||
7246|054|S|   Remember that this medication has been prescribed because your||
7246|055|S|doctor has judged that the benefit to you is greater than the||
7246|056|S|risk of side effects. Many people using this medication do not||
7246|057|S|have serious side effects.||
7246|058|S|   Tell your doctor right away if you have any serious side||
7246|059|S|effects, including: swelling at injection site, shortness of||
7246|060|S|breath, fast heartbeat, signs of kidney problems (such as change||
7246|061|S|in the amount of urine), swelling of the ankles/feet,||
7246|062|S|pain/redness/swelling of arms or legs, new or increased||
7246|063|S|bleeding/bruising.||
7246|064|S|   Get medical help right away if you have any very serious side||
7246|065|S|effects, including: bluish fingers, chest pain, trouble||
7246|066|S|breathing.||
7246|067|S|   A very serious allergic reaction to this drug is rare.||
7246|068|S|However, get medical help right away if you notice any symptoms||
7246|069|S|of a serious allergic reaction, including: rash, itching/swelling||
7246|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7246|071|S|breathing.||
7246|072|S|   This is not a complete list of possible side effects. If you||
7246|073|S|notice other effects not listed above, contact your doctor or||
7246|074|S|pharmacist.||
7246|075|S|   In the US -||
7246|076|S|   Call your doctor for medical advice about side effects. You||
7246|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7246|078|S|www.fda.gov/medwatch.||
7246|079|S|   In Canada - Call your doctor for medical advice about side||
7246|080|S|effects. You may report side effects to Health Canada at||
7246|081|S|1-866-234-2345.||
7246|082|B|||
7246|083|P|PRECAUTIONS:  Before using factor IX, tell your doctor or||
7246|084|P|pharmacist if you are allergic to factor IX products; or if you||
7246|085|P|have any other allergies. This product may contain inactive||
7246|086|P|ingredients (such as latex), which can cause allergic reactions||
7246|087|P|or other problems. Talk to your pharmacist for more details.||
7246|088|P|   Before using this medication, tell your doctor or pharmacist||
7246|089|P|your medical history, especially of: other clotting disorders||
7246|090|P|(such as disseminated intravascular coagulation-DIC), recent||
7246|091|P|surgery/procedure, liver disease.||
7246|092|P|   Before having surgery, tell your doctor or dentist about all||
7246|093|P|the products you use (including prescription drugs,||
7246|094|P|nonprescription drugs, and herbal products).||
7246|095|P|   During pregnancy, this medication should be used only when||
7246|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
7246|097|P|   It is unknown if this medication passes into breast milk.||
7246|098|P|Consult your doctor before breastfeeding.||
7246|099|B|||
7246|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7246|101|I|medications work or increase your risk for serious side effects.||
7246|102|I|This document does not contain all possible drug interactions.||
7246|103|I|Keep a list of all the products you use (including||
7246|104|I|prescription/nonprescription drugs and herbal products) and share||
7246|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
7246|106|I|the dosage of any medicines without your doctor's approval.||
7246|107|I|   Some products that may interact with this drug include: drugs||
7246|108|I|that help with clotting (such as aminocaproic acid, tranexamic||
7246|109|I|acid).||
7246|110|B|||
7246|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7246|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7246|113|O|poison control center right away. US residents can call||
7246|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7246|115|B|||
7246|116|N|NOTES:  Do not share this medication with others.||
7246|117|N|   Lab and/or medical tests (such as factor IX activity) should||
7246|118|N|be done while you are using this medication. Keep all medical and||
7246|119|N|lab appointments. Consult your doctor for more details.||
7246|120|B|||
7246|121|D|MISSED DOSE:  It is important to get each dose of this medication||
7246|122|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7246|123|D|right away for a new dosing schedule. Do not double the dose to||
7246|124|D|catch up.||
7246|125|B|||
7246|126|R|STORAGE:  Consult the product instructions and your pharmacist||
7246|127|R|for storage details. Keep all medications away from children and||
7246|128|R|pets.||
7246|129|R|   Do not flush medications down the toilet or pour them into a||
7246|130|R|drain unless instructed to do so. Properly discard this product||
7246|131|R|when it is expired or no longer needed. Consult your pharmacist||
7246|132|R|or local waste disposal company.||
7246|133|B|||
7246|134|M|MEDICAL ALERT:  Your condition can cause complications in a||
7246|135|M|medical emergency. For information about enrolling in MedicAlert,||
7246|136|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7246|137|B|||
7246|138|A|Information last revised November 2024.||
7246|139|A|Copyright(c) 2025 First Databank, Inc.||
7246|140|B|||
7247|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7247|002|Z|does NOT have all possible information about this product. This||
7247|003|Z|information does not assure that this product is safe, effective,||
7247|004|Z|or appropriate for you. This information is not individual||
7247|005|Z|medical advice and does not substitute for the advice of your||
7247|006|Z|health care professional. Always ask your health care||
7247|007|Z|professional for complete information about this product and your||
7247|008|Z|specific health needs.||
7247|009|B|||
7247|010|T|TERBUTALINE BREATH-ACTIVATED INHALER - ORAL INHALATION||
7247|011|F|(ter-BUE-ta-leen)||
7247|012|B|||
7247|013|U|USES:  Terbutaline is used to treat wheezing and shortness of||
7247|014|U|breath caused by breathing problems (such as asthma, chronic||
7247|015|U|obstructive pulmonary disease). It is a quick-relief medication.||
7247|016|U|Terbutaline belongs to a class of drugs known as bronchodilators.||
7247|017|U|It works by relaxing the muscles around the airways so that they||
7247|018|U|open up and you can breathe more easily. Controlling symptoms of||
7247|019|U|breathing problems can decrease time lost from work or school.||
7247|020|B|||
7247|021|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
7247|022|H|your pharmacist before you start using this medication and each||
7247|023|H|time you get a refill. Follow the illustrated directions for the||
7247|024|H|proper use of this medication and device. If you have any||
7247|025|H|questions, ask your doctor or pharmacist.||
7247|026|H|   Inhale this medication by mouth as directed by your doctor,||
7247|027|H|usually 1 dose as needed. Your doctor may direct you to use||
7247|028|H|additional doses if your symptoms last after the first dose.||
7247|029|H|Carefully follow your doctor's directions. Do not use more than 6||
7247|030|H|doses in a 24-hour period.||
7247|031|H|   Before using, remove the cover. To load a dose, hold the||
7247|032|H|inhaler upright with the grip downward. Turn the blue grip as far||
7247|033|H|as it will go in one direction, then turn it back to the original||
7247|034|H|position. You should hear a click, which means the inhaler is||
7247|035|H|ready for use. Place the mouthpiece near your mouth and breathe||
7247|036|H|out as far as is comfortable. Do not breathe into the inhaler||
7247|037|H|device. Then place the mouthpiece between your teeth, close your||
7247|038|H|lips, and breathe in forcefully and deeply through your mouth.||
7247|039|H|You may not taste or feel the drug when you breathe it in. This||
7247|040|H|is normal. Remove the inhaler from your mouth before breathing||
7247|041|H|out. Replace the cover after each use. To decrease the risk of||
7247|042|H|side effects, rinse your mouth with water after using the||
7247|043|H|inhaler.||
7247|044|H|   If you accidentally drop, shake, or breathe out into the||
7247|045|H|inhaler after it is loaded, you will lose your dose and must||
7247|046|H|reload a new dose before use. Do not use the inhaler if it has||
7247|047|H|been damaged or if the mouthpiece has come off.||
7247|048|H|   If you are using other inhalers at the same time, wait at||
7247|049|H|least 1 minute between the use of each medication.||
7247|050|H|   Clean the outside of the mouthpiece with a dry tissue once a||
7247|051|H|week. Do not use water or any other liquid for cleaning. If||
7247|052|H|liquid gets into the inhaler, it may not work properly.||
7247|053|H|   The dosage is based on your medical condition and response to||
7247|054|H|treatment. Do not increase your dose or use it more often than||
7247|055|H|prescribed.||
7247|056|H|   Keep track of the number of inhalations used from each device.||
7247|057|H|Discard the device after you have used the number of inhalations||
7247|058|H|marked on the manufacturer's package.||
7247|059|H|   Learn which of your inhalers you should use every day||
7247|060|H|(controller drugs) and which you should use if your breathing||
7247|061|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
7247|062|H|time what you should do if you have new or worsening cough or||
7247|063|H|shortness of breath, wheezing, increased sputum, worsening peak||
7247|064|H|flow meter readings, waking up at night with trouble breathing,||
7247|065|H|if you use your quick-relief inhaler more often (more than 2 days||
7247|066|H|a week), or if your quick-relief inhaler does not seem to be||
7247|067|H|working well. Learn when you can treat sudden breathing problems||
7247|068|H|by yourself and when you must get medical help right away.||
7247|069|H|   Tell your doctor if your symptoms do not get better or if they||
7247|070|H|get worse.||
7247|071|B|||
7247|072|S|SIDE EFFECTS:  Nervousness, dizziness, shaking (tremor), trouble||
7247|073|S|sleeping, headache, nausea, or sweating may occur. If any of||
7247|074|S|these effects last or get worse, tell your doctor or pharmacist||
7247|075|S|promptly.||
7247|076|S|   Remember that this medication has been prescribed because your||
7247|077|S|doctor has judged that the benefit to you is greater than the||
7247|078|S|risk of side effects. Many people using this medication do not||
7247|079|S|have serious side effects.||
7247|080|S|   This medication may raise your blood pressure. Check your||
7247|081|S|blood pressure regularly and tell your doctor if the results are||
7247|082|S|high.||
7247|083|S|   Tell your doctor right away if you have any serious side||
7247|084|S|effects, including: fast/pounding/irregular heartbeat, muscle||
7247|085|S|cramps/weakness, increased thirst/urination.||
7247|086|S|   Get medical help right away if you have any very serious side||
7247|087|S|effects, including: chest pain, rapid breathing, confusion.||
7247|088|S|   Rarely, this medication has caused severe (rarely fatal),||
7247|089|S|sudden worsening of breathing problems/asthma (paradoxical||
7247|090|S|bronchospasm). If you experience sudden wheezing, get medical||
7247|091|S|help right away.||
7247|092|S|   A very serious allergic reaction to this drug is rare.||
7247|093|S|However, get medical help right away if you notice any symptoms||
7247|094|S|of a serious allergic reaction, including: rash, itching/swelling||
7247|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7247|096|S|breathing.||
7247|097|S|   This is not a complete list of possible side effects. If you||
7247|098|S|notice other effects not listed above, contact your doctor or||
7247|099|S|pharmacist.||
7247|100|S|   In the US -||
7247|101|S|   Call your doctor for medical advice about side effects. You||
7247|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7247|103|S|www.fda.gov/medwatch.||
7247|104|S|   In Canada - Call your doctor for medical advice about side||
7247|105|S|effects. You may report side effects to Health Canada at||
7247|106|S|1-866-234-2345.||
7247|107|B|||
7247|108|P|PRECAUTIONS:  Before using terbutaline, tell your doctor or||
7247|109|P|pharmacist if you are allergic to it; or to similar||
7247|110|P|bronchodilators (such as salbutamol, salmeterol); or if you have||
7247|111|P|any other allergies. This product may contain inactive||
7247|112|P|ingredients, which can cause allergic reactions or other||
7247|113|P|problems. Talk to your pharmacist for more details.||
7247|114|P|   Before using this medication, tell your doctor or pharmacist||
7247|115|P|your medical history, especially of: diabetes, heart problems||
7247|116|P|(such as irregular heartbeat, angina, previous heart attack),||
7247|117|P|high blood pressure, seizure, overactive thyroid||
7247|118|P|(hyperthyroidism).||
7247|119|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7247|120|P|can make you more dizzy. Do not drive, use machinery, or do||
7247|121|P|anything that needs alertness until you can do it safely. Limit||
7247|122|P|alcoholic beverages. Talk to your doctor if you are using||
7247|123|P|marijuana (cannabis).||
7247|124|P|   Before having surgery, tell your doctor or dentist about all||
7247|125|P|the products you use (including prescription drugs,||
7247|126|P|nonprescription drugs, and herbal products).||
7247|127|P|   During pregnancy, this medication should be used only when||
7247|128|P|clearly needed. Discuss the risks and benefits with your doctor.||
7247|129|P|   This drug passes into breast milk. Consult your doctor before||
7247|130|P|breastfeeding.||
7247|131|B|||
7247|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7247|133|I|medications work or increase your risk for serious side effects.||
7247|134|I|This document does not contain all possible drug interactions.||
7247|135|I|Keep a list of all the products you use (including||
7247|136|I|prescription/nonprescription drugs and herbal products) and share||
7247|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
7247|138|I|the dosage of any medicines without your doctor's approval.||
7247|139|B|||
7247|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7247|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7247|142|O|poison control center right away. US residents can call||
7247|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7247|144|O|Symptoms of overdose may include: severe dizziness,||
7247|145|O|fast/irregular heartbeat, chest pain.||
7247|146|B|||
7247|147|N|NOTES:  Do not share this medication with others.||
7247|148|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
7247|149|N|EKG, blood potassium levels, blood sugar) may be done while you||
7247|150|N|are using this medication. Keep all medical and lab appointments.||
7247|151|N|Consult your doctor for more details.||
7247|152|N|   Avoid allergens/irritants that can worsen breathing problems,||
7247|153|N|such as smoke, pollen, pet dander, dust, or molds.||
7247|154|N|   Learn to use a peak flow meter, use it daily, and promptly||
7247|155|N|report worsening breathing problems (such as readings in the||
7247|156|N|yellow/red range, increased use of quick-relief inhalers).||
7247|157|N|   Because the flu virus can worsen breathing problems, ask your||
7247|158|N|doctor or pharmacist if you should have a flu shot every year.||
7247|159|B|||
7247|160|D|MISSED DOSE:  Not applicable.||
7247|161|B|||
7247|162|R|STORAGE:  Store at room temperature away from light and moisture.||
7247|163|R|Do not store in the bathroom. Keep all medications away from||
7247|164|R|children and pets.||
7247|165|R|   Do not flush medications down the toilet or pour them into a||
7247|166|R|drain unless instructed to do so. Properly discard this product||
7247|167|R|when it is expired or no longer needed. Consult your pharmacist||
7247|168|R|or local waste disposal company.||
7247|169|B|||
7247|170|M|MEDICAL ALERT:  Your condition can cause complications in a||
7247|171|M|medical emergency. For information about enrolling in MedicAlert,||
7247|172|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7247|173|B|||
7247|174|A|Information last revised October 2024.||
7247|175|A|Copyright(c) 2025 First Databank, Inc.||
7247|176|B|||
7253|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7253|002|Z|does NOT have all possible information about this product. This||
7253|003|Z|information does not assure that this product is safe, effective,||
7253|004|Z|or appropriate for you. This information is not individual||
7253|005|Z|medical advice and does not substitute for the advice of your||
7253|006|Z|health care professional. Always ask your health care||
7253|007|Z|professional for complete information about this product and your||
7253|008|Z|specific health needs.||
7253|009|B|||
7253|010|T|HYDROCORTISONE/IODOQUINOL - TOPICAL||
7253|011|F|(HYE-droe-KOR-ti-sone/eye-oh-doh-KWIN-ohl)||
7253|012|B|||
7253|013|C|COMMON BRAND NAME(S): Alcortin A, Vytone||
7253|014|B|||
7253|015|U|USES:  This combination medication is used to treat a variety of||
7253|016|U|skin conditions (including eczema, fungal skin infections such as||
7253|017|U|ringworm/athlete's foot/jock itch). This product contains 2||
7253|018|U|medications. Iodoquinol is an antibiotic that works by preventing||
7253|019|U|the growth of fungus/bacteria. Hydrocortisone is a mild||
7253|020|U|corticosteroid that works by reducing the swelling, redness, and||
7253|021|U|itching that occurs in the affected skin.||
7253|022|B|||
7253|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
7253|024|H|thoroughly dry the area to be treated. Apply a thin layer of the||
7253|025|H|medication to the affected area and gently rub in as directed by||
7253|026|H|your doctor, usually 3 to 4 times daily. Wash your hands after||
7253|027|H|using unless you are using this medication to treat the hands.||
7253|028|H|   Do not wrap, cover, or bandage the area unless directed to do||
7253|029|H|so by your doctor.||
7253|030|H|   Do not apply the medication in the eyes, nose, mouth, or||
7253|031|H|inside the vagina. If you do get the medication in those areas,||
7253|032|H|flush with plenty of water.||
7253|033|H|   Do not apply more often or use longer than prescribed. Doing||
7253|034|H|so may increase the risk of side effects.||
7253|035|H|   Use this medication regularly to get the most benefit from it.||
7253|036|H|To help you remember, use it at the same times each day.||
7253|037|H|   Continue to use this medication until the full prescribed||
7253|038|H|amount is finished, even if symptoms disappear after a few days.||
7253|039|H|Stopping the medication too early may result in a return of the||
7253|040|H|infection.||
7253|041|H|   Tell your doctor if your condition lasts or gets worse.||
7253|042|B|||
7253|043|S|SIDE EFFECTS:  Dry skin may occur. If this effect lasts or gets||
7253|044|S|worse, tell your doctor or pharmacist promptly.||
7253|045|S|   Remember that this medication has been prescribed because your||
7253|046|S|doctor has judged that the benefit to you is greater than the||
7253|047|S|risk of side effects. Many people using this medication do not||
7253|048|S|have serious side effects.||
7253|049|S|   Tell your doctor right away if you have any serious side||
7253|050|S|effects, including: skin irritation/burning, extreme hair growth,||
7253|051|S|skin thinning/discoloration, acne, stretch marks, small red bumps||
7253|052|S|on the skin (folliculitis).||
7253|053|S|   Use of this medication for prolonged or repeated periods may||
7253|054|S|result in a new infection. Contact your doctor if you notice any||
7253|055|S|new symptoms on the skin.||
7253|056|S|   A very serious allergic reaction to this drug is rare.||
7253|057|S|However, get medical help right away if you notice any symptoms||
7253|058|S|of a serious allergic reaction, including: rash, itching/swelling||
7253|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7253|060|S|breathing.||
7253|061|S|   This is not a complete list of possible side effects. If you||
7253|062|S|notice other effects not listed above, contact your doctor or||
7253|063|S|pharmacist.||
7253|064|S|   In the US -||
7253|065|S|   Call your doctor for medical advice about side effects. You||
7253|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7253|067|S|www.fda.gov/medwatch.||
7253|068|S|   In Canada - Call your doctor for medical advice about side||
7253|069|S|effects. You may report side effects to Health Canada at||
7253|070|S|1-866-234-2345.||
7253|071|B|||
7253|072|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
7253|073|P|pharmacist if you are allergic to iodoquinol or hydrocortisone;||
7253|074|P|or to other 8-hydroxyquinolines (such as clioquinol); or to other||
7253|075|P|corticosteroids (such as triamcinolone); or to iodine; or if you||
7253|076|P|have any other allergies. This product may contain inactive||
7253|077|P|ingredients, which can cause allergic reactions or other||
7253|078|P|problems. Talk to your pharmacist for more details.||
7253|079|P|   Before using this medication, tell your doctor or pharmacist||
7253|080|P|your medical history, especially of: immune system problems, poor||
7253|081|P|blood circulation, tuberculosis of the skin, viral skin/eye||
7253|082|P|infections (such as herpes, chickenpox).||
7253|083|P|   This medication may stain the skin or clothes. Use cautiously||
7253|084|P|to avoid contact with clothes.||
7253|085|P|   Children may be more sensitive to the effects of too much||
7253|086|P|corticosteroid medication. Consult your doctor for more details.||
7253|087|P|   During pregnancy, this medication should be used only when||
7253|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
7253|089|P|   It is unknown if this medication passes into breast milk.||
7253|090|P|Consult your doctor before breastfeeding.||
7253|091|B|||
7253|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7253|093|I|medications work or increase your risk for serious side effects.||
7253|094|I|This document does not contain all possible drug interactions.||
7253|095|I|Keep a list of all the products you use (including||
7253|096|I|prescription/nonprescription drugs and herbal products) and share||
7253|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
7253|098|I|the dosage of any medicines without your doctor's approval.||
7253|099|I|   This medication may interfere with certain lab tests (such as||
7253|100|I|certain thyroid function tests and certain test for||
7253|101|I|phenylketonuria), possibly causing false test results. Make sure||
7253|102|I|lab personnel and all your doctors know you use this drug.||
7253|103|B|||
7253|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7253|105|O|has overdosed and has serious symptoms such as passing out or||
7253|106|O|trouble breathing, call 911. Otherwise, call a poison control||
7253|107|O|center right away. US residents can call 1-800-222-1222. Canada||
7253|108|O|residents can call 1-844-764-7669.||
7253|109|B|||
7253|110|N|NOTES:  Do not share this medication with others.||
7253|111|N|   This medication has been prescribed for your current condition||
7253|112|N|only. Do not use it later for another skin condition unless told||
7253|113|N|to do so by your doctor. A different medication may be necessary||
7253|114|N|in that case.||
7253|115|B|||
7253|116|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7253|117|D|If it is near the time of the next dose, skip the missed dose.||
7253|118|D|Use your next dose at the regular time. Do not double the dose to||
7253|119|D|catch up.||
7253|120|B|||
7253|121|R|STORAGE:  Store at room temperature away from heat. Keep all||
7253|122|R|medications away from children and pets.||
7253|123|R|   Do not flush medications down the toilet or pour them into a||
7253|124|R|drain unless instructed to do so. Properly discard this product||
7253|125|R|when it is expired or no longer needed. Consult your pharmacist||
7253|126|R|or local waste disposal company.||
7253|127|B|||
7253|128|A|Information last revised May 2024.||
7253|129|A|Copyright(c) 2025 First Databank, Inc.||
7253|130|B|||
7263|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7263|002|Z|does NOT have all possible information about this product. This||
7263|003|Z|information does not assure that this product is safe, effective,||
7263|004|Z|or appropriate for you. This information is not individual||
7263|005|Z|medical advice and does not substitute for the advice of your||
7263|006|Z|health care professional. Always ask your health care||
7263|007|Z|professional for complete information about this product and your||
7263|008|Z|specific health needs.||
7263|009|B|||
7263|010|T|GUAIFENESIN/OXTRIPHYLLINE - ORAL||
7263|011|F|(gweye-FEN-eh-sin/ox-TRY-fill-in)||
7263|012|B|||
7263|013|U|USES:  This medication contains 2 drugs (oxtriphylline and||
7263|014|U|guaifenesin) and is used to treat and prevent wheezing and||
7263|015|U|trouble breathing caused by ongoing lung disease (such as asthma,||
7263|016|U|chronic bronchitis, emphysema). Oxtriphylline belongs to a class||
7263|017|U|of drugs known as xanthines and is changed in the body to||
7263|018|U|theophylline. Theophylline works by relaxing the muscles around||
7263|019|U|the airways so that they open up and you can breathe more easily.||
7263|020|U|It also decreases the lungs' response to irritants. Guaifenesin||
7263|021|U|is an expectorant that helps thin and loosen mucus in the lungs,||
7263|022|U|making it easier to cough up the mucus. Controlling symptoms of||
7263|023|U|breathing problems can decrease time lost from work or school.||
7263|024|U|   This medication does not work right away and should not be||
7263|025|U|used to relieve sudden attacks of breathing trouble. If an attack||
7263|026|U|occurs, use your quick-relief inhaler (such as albuterol) as||
7263|027|U|prescribed by your doctor.||
7263|028|B|||
7263|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
7263|030|H|doctor, usually every 6 hours with a full glass of water (8||
7263|031|H|ounces or 240 milliliters). If stomach upset occurs, take it with||
7263|032|H|food. Carefully measure the dose using a special measuring||
7263|033|H|device/spoon. Do not use a household spoon because you may not||
7263|034|H|get the correct dose.||
7263|035|H|   The dosage is based on your age, medical condition, response||
7263|036|H|to treatment, and other drugs you may be taking. (See also Drug||
7263|037|H|Interactions section.)||
7263|038|H|   Alcohol and caffeine can increase the side effects of this||
7263|039|H|medication. Avoid drinking large amounts of beverages containing||
7263|040|H|alcohol or caffeine (coffee, tea, colas), eating large amounts of||
7263|041|H|chocolate, or taking nonprescription products that contain||
7263|042|H|caffeine.||
7263|043|H|   This medicine works best when the amount in your body is kept||
7263|044|H|at a constant level. Use this drug at evenly spaced intervals. To||
7263|045|H|help you remember, take it at the same times each day. Do not||
7263|046|H|increase your dose unless your doctor directs you to do so.||
7263|047|H|Taking too much of this medication may cause serious side||
7263|048|H|effects.||
7263|049|H|   Learn which of your medications you should use every day||
7263|050|H|(controller drugs such as this medication) and which you should||
7263|051|H|use if your breathing suddenly worsens (quick-relief drugs). Ask||
7263|052|H|your doctor ahead of time what you should do if you have new or||
7263|053|H|worsening cough or shortness of breath, wheezing, increased||
7263|054|H|sputum, worsening peak flow meter readings, waking up at night||
7263|055|H|with trouble breathing, if you use your quick-relief inhaler more||
7263|056|H|often (more than 2 days a week), or if your quick-relief inhaler||
7263|057|H|does not seem to be working well. Learn when you can treat sudden||
7263|058|H|breathing problems by yourself and when you must get medical help||
7263|059|H|right away.||
7263|060|B|||
7263|061|S|SIDE EFFECTS:  Stomach pain/cramping, pounding heartbeat, nausea,||
7263|062|S|vomiting, headache, trouble sleeping, diarrhea, irritability,||
7263|063|S|restlessness, shaking, and increased urination may occur. If any||
7263|064|S|of these effects last or get worse, tell your doctor or||
7263|065|S|pharmacist promptly.||
7263|066|S|   Remember that this medication has been prescribed because your||
7263|067|S|doctor has judged that the benefit to you is greater than the||
7263|068|S|risk of side effects. Many people using this medication do not||
7263|069|S|have serious side effects.||
7263|070|S|   Tell your doctor right away if you have any serious side||
7263|071|S|effects, including: fast/irregular heartbeat, seizures.||
7263|072|S|   A very serious allergic reaction to this drug is rare.||
7263|073|S|However, get medical help right away if you notice any symptoms||
7263|074|S|of a serious allergic reaction, including: rash, itching/swelling||
7263|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7263|076|S|breathing.||
7263|077|S|   This is not a complete list of possible side effects. If you||
7263|078|S|notice other effects not listed above, contact your doctor or||
7263|079|S|pharmacist.||
7263|080|S|   In the US -||
7263|081|S|   Call your doctor for medical advice about side effects. You||
7263|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7263|083|S|www.fda.gov/medwatch.||
7263|084|S|   In Canada - Call your doctor for medical advice about side||
7263|085|S|effects. You may report side effects to Health Canada at||
7263|086|S|1-866-234-2345.||
7263|087|B|||
7263|088|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
7263|089|P|pharmacist if you are allergic to it; or to similar drugs (such||
7263|090|P|as dyphylline, theophylline); or if you have any other allergies.||
7263|091|P|This product may contain inactive ingredients, which can cause||
7263|092|P|allergic reactions or other problems. Talk to your pharmacist for||
7263|093|P|more details.||
7263|094|P|   Before using this medication, tell your doctor or pharmacist||
7263|095|P|your medical history, especially of: heart problems (such as||
7263|096|P|angina, fast/irregular heartbeat, heart failure, recent heart||
7263|097|P|attack), high blood pressure, kidney disease, liver disease,||
7263|098|P|seizures, stomach/intestinal ulcer, thyroid problems (underactive||
7263|099|P|or overactive), a certain lung problem (cystic fibrosis), fluid||
7263|100|P|in the lungs.||
7263|101|P|   If you get sick or have a fever while taking this medication,||
7263|102|P|tell your doctor right away. The dose of your medicine may need||
7263|103|P|to be adjusted.||
7263|104|P|   This product contains sugar and alcohol. If you have diabetes,||
7263|105|P|alcohol dependence, or liver disease, consult your doctor or||
7263|106|P|pharmacist about using this product safely.||
7263|107|P|   Before having surgery, tell your doctor or dentist about all||
7263|108|P|the products you use (including prescription drugs,||
7263|109|P|nonprescription drugs, and herbal products).||
7263|110|P|   During pregnancy, this medication should be used only when||
7263|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
7263|112|P|   This medication passes into breast milk. However, it is||
7263|113|P|unlikely to harm a nursing infant. Consult your doctor before||
7263|114|P|breastfeeding.||
7263|115|B|||
7263|116|I|DRUG INTERACTIONS:  See also How to Use section.||
7263|117|I|   Drug interactions may change how your medications work or||
7263|118|I|increase your risk for serious side effects. This document does||
7263|119|I|not contain all possible drug interactions. Keep a list of all||
7263|120|I|the products you use (including prescription/nonprescription||
7263|121|I|drugs and herbal products) and share it with your doctor and||
7263|122|I|pharmacist. Do not start, stop, or change the dosage of any||
7263|123|I|medicines without your doctor's approval.||
7263|124|I|   A product that may interact with this drug is: lithium.||
7263|125|I|   Other medications can affect the removal of this medication||
7263|126|I|from your body, which may affect how this medication works.||
7263|127|I|Examples include cimetidine, ciprofloxacin, disulfiram,||
7263|128|I|fluvoxamine, interferon alpha, certain macrolide antibiotics||
7263|129|I|(clarithromycin, erythromycin), mexiletine, nefazodone, St.||
7263|130|I|John's wort, drugs to treat seizures (such as carbamazepine,||
7263|131|I|phenobarbital, phenytoin), tacrine, among others.||
7263|132|I|   Check the labels on all your medicines (such as cough-and-cold||
7263|133|I|products, diet aids) because they may contain ingredients (such||
7263|134|I|as ephedrine, pseudoephedrine, phenylephrine) that could increase||
7263|135|I|the side effects of this medication. Ask your pharmacist about||
7263|136|I|using those products safely.||
7263|137|I|   Oxtriphylline is very similar to theophylline. Do not take||
7263|138|I|medications containing theophylline while using oxtriphylline.||
7263|139|I|   Cigarette smoking decreases blood levels of this medication.||
7263|140|I|Tell your doctor if you smoke or if you have recently stopped||
7263|141|I|smoking.||
7263|142|I|   This medication may interfere with certain lab tests (such as||
7263|143|I|stress tests, uric acid levels), possibly causing false test||
7263|144|I|results. Make sure lab personnel and all your doctors know you||
7263|145|I|use this drug.||
7263|146|B|||
7263|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7263|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7263|149|O|poison control center right away. US residents can call||
7263|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7263|151|O|Symptoms of overdose may include: agitation, severe vomiting,||
7263|152|O|extreme thirst, ringing in the ears, increased sweating,||
7263|153|O|fainting, chest pain, fast/irregular heartbeat, seizures.||
7263|154|B|||
7263|155|N|NOTES:  Do not share this medication with others.||
7263|156|N|   Avoid substances that can worsen breathing problems by causing||
7263|157|N|irritation or allergic reaction, such as smoke, pollen, pet||
7263|158|N|dander, dust, and mold.||
7263|159|N|   Lab and/or medical tests (such as blood levels for this drug)||
7263|160|N|may be done while you are taking this medication. Keep all||
7263|161|N|medical and lab appointments. Consult your doctor for more||
7263|162|N|details.||
7263|163|N|   To help loosen mucus, drink plenty of fluids while taking this||
7263|164|N|medication unless your doctor instructs you otherwise.||
7263|165|N|   If you have asthma, learn to use a peak flow meter, use it||
7263|166|N|daily, and promptly report worsening breathing problems (such as||
7263|167|N|readings in the yellow/red range, increased use of quick-relief||
7263|168|N|inhalers).||
7263|169|N|   Because the flu virus can worsen breathing problems, ask your||
7263|170|N|doctor or pharmacist if you should have a flu shot every year.||
7263|171|B|||
7263|172|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
7263|173|D|next dose at the regular time. Do not double the dose to catch||
7263|174|D|up.||
7263|175|B|||
7263|176|R|STORAGE:  Store at room temperature away from light and moisture.||
7263|177|R|Keep all medications away from children and pets.||
7263|178|R|   Do not flush medications down the toilet or pour them into a||
7263|179|R|drain unless instructed to do so. Properly discard this product||
7263|180|R|when it is expired or no longer needed. Consult your pharmacist||
7263|181|R|or local waste disposal company.||
7263|182|B|||
7263|183|M|MEDICAL ALERT:  Your condition can cause complications in a||
7263|184|M|medical emergency. For information about enrolling in MedicAlert,||
7263|185|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7263|186|B|||
7263|187|A|Information last revised December 2024.||
7263|188|A|Copyright(c) 2025 First Databank, Inc.||
7263|189|B|||
7268|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7268|002|Z|does NOT have all possible information about this product. This||
7268|003|Z|information does not assure that this product is safe, effective,||
7268|004|Z|or appropriate for you. This information is not individual||
7268|005|Z|medical advice and does not substitute for the advice of your||
7268|006|Z|health care professional. Always ask your health care||
7268|007|Z|professional for complete information about this product and your||
7268|008|Z|specific health needs.||
7268|009|B|||
7268|010|T|LAMIVUDINE SOLUTION - ORAL||
7268|011|F|(la-MIV-ue-deen)||
7268|012|B|||
7268|013|C|COMMON BRAND NAME(S): Epivir||
7268|014|B|||
7268|015|W|WARNING:  If you have hepatitis B infection along with HIV, your||
7268|016|W|hepatitis symptoms may get worse or become very serious if you||
7268|017|W|stop taking lamivudine. Talk with your doctor before stopping||
7268|018|W|this medication. Your doctor will perform liver function tests||
7268|019|W|for several months after you stop lamivudine. Tell your doctor||
7268|020|W|right away if you develop symptoms of worsening liver problems.||
7268|021|W|   Different brands of this drug have different amounts of drug.||
7268|022|W|Do not switch brands of this medication without first checking||
7268|023|W|with your doctor. If you have HIV infection (with or without||
7268|024|W|hepatitis B infection), you should be taking the higher-strength||
7268|025|W|dosage. Consult your doctor or pharmacist.||
7268|026|B|||
7268|027|U|USES:  This drug is used with other HIV medications to help||
7268|028|U|control HIV infection. It helps to decrease the amount of HIV in||
7268|029|U|your body so your immune system can work better. This lowers your||
7268|030|U|chance of getting HIV complications (such as new infections,||
7268|031|U|cancer) and improves your quality of life. Lamivudine belongs to||
7268|032|U|a class of drugs known as nucleoside reverse transcriptase||
7268|033|U|inhibitors-NRTI.||
7268|034|U|   Lamivudine is not a cure for HIV infection. To decrease your||
7268|035|U|risk of spreading HIV disease to others, continue to take all HIV||
7268|036|U|medications exactly as prescribed by your doctor. Use an||
7268|037|U|effective barrier method (latex or polyurethane condoms/dental||
7268|038|U|dams) during sexual activity as directed by your doctor. Do not||
7268|039|U|share personal items (such as needles/syringes, toothbrushes, and||
7268|040|U|razors) that may have contacted blood or other body fluids.||
7268|041|U|Consult your doctor or pharmacist for more details.||
7268|042|B|||
7268|043|V|OTHER USES:  This section contains uses of this drug that are not||
7268|044|V|listed in the approved professional labeling for the drug but||
7268|045|V|that may be prescribed by your health care professional. Use this||
7268|046|V|drug for a condition that is listed in this section only if it||
7268|047|V|has been so prescribed by your health care professional.||
7268|048|V|   This product may also be used to lessen the risk of HIV||
7268|049|V|infection after contact with the virus (for example, due to a||
7268|050|V|needle stick). Ask your doctor for more details.||
7268|051|V|   A lower-strength lamivudine product is used for hepatitis B||
7268|052|V|infection in people without HIV infection.||
7268|053|B|||
7268|054|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7268|055|H|from your pharmacist before you start taking lamivudine and each||
7268|056|H|time you get a refill. If you have any questions, ask your doctor||
7268|057|H|or pharmacist.||
7268|058|H|   Take this medication by mouth with or without food as directed||
7268|059|H|by your doctor, usually once or twice daily. Carefully measure||
7268|060|H|the dose using a special measuring device/spoon. Do not use a||
7268|061|H|household spoon because you may not get the correct dose.||
7268|062|H|   The dosage is based on your medical condition and response to||
7268|063|H|treatment. Children's dosage is also based on weight.||
7268|064|H|   It is very important to keep taking this medication (and other||
7268|065|H|HIV medications) exactly as prescribed by your doctor. Do not||
7268|066|H|skip any doses. Do not increase your dose, take this drug more||
7268|067|H|often than prescribed, or stop taking it (or other HIV medicines)||
7268|068|H|even for a short time unless directed to do so by your doctor.||
7268|069|H|Skipping or changing your dose without approval from your doctor||
7268|070|H|may cause the amount of virus to increase, make the infection||
7268|071|H|more difficult to treat (resistant), or worsen side effects.||
7268|072|H|   For the best effect, take this medication at evenly spaced||
7268|073|H|times. To help you remember, take this medication at the same||
7268|074|H|time(s) every day.||
7268|075|H|   For children, the liquid form of this medication may not work||
7268|076|H|as well as the tablet form. If your child is able to swallow||
7268|077|H|tablets, ask the doctor if your child should be switched to the||
7268|078|H|tablet form of this medication.||
7268|079|B|||
7268|080|S|SIDE EFFECTS:  See also Warning section.||
7268|081|S|   Headache, dizziness, nausea, diarrhea, or trouble sleeping may||
7268|082|S|occur. If any of these effects last or get worse, tell your||
7268|083|S|doctor or pharmacist promptly.||
7268|084|S|   Remember that this medication has been prescribed because your||
7268|085|S|doctor has judged that the benefit to you is greater than the||
7268|086|S|risk of side effects. Many people using this medication do not||
7268|087|S|have serious side effects.||
7268|088|S|   Rarely, lamivudine has caused severe (sometimes fatal) liver||
7268|089|S|problems and a buildup of lactic acid in the blood (lactic||
7268|090|S|acidosis). These serious side effects may occur more often in||
7268|091|S|women and obese patients. Get medical help right away if you have||
7268|092|S|any of the following serious symptoms, including: symptoms of||
7268|093|S|liver problems (such as nausea/vomiting that doesn't stop, loss||
7268|094|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
7268|095|S|urine), symptoms of lactic acidosis (such as deep/rapid||
7268|096|S|breathing, drowsiness, nausea/vomiting).||
7268|097|S|   As your immune system gets stronger, it can begin to fight off||
7268|098|S|infections you already had, possibly causing disease symptoms to||
7268|099|S|come back. You could also have symptoms if your immune system||
7268|100|S|becomes overactive. This reaction may happen at any time (soon||
7268|101|S|after starting HIV treatment or many months later). Tell your||
7268|102|S|doctor right away if you have any serious symptoms, including:||
7268|103|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
7268|104|S|that doesn't go away, headaches that are severe or don't go away,||
7268|105|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
7268|106|S|changes, signs of infection (such as sore throat that doesn't go||
7268|107|S|away, fever, chills, swollen lymph nodes, non-healing skin||
7268|108|S|sores), signs of an overactive thyroid (such as irritability,||
7268|109|S|nervousness, heat intolerance, fast/pounding/irregular||
7268|110|S|heartbeat).||
7268|111|S|   Tell your doctor right away if you have any serious side||
7268|112|S|effects, including: mental/mood changes (such as depression),||
7268|113|S|stomach/back pain with nausea (pancreatitis), easy||
7268|114|S|bleeding/bruising, signs of anemia (unusual tiredness, rapid||
7268|115|S|heartbeat, pale/bluish skin).||
7268|116|S|   A very serious allergic reaction to this drug is rare.||
7268|117|S|However, get medical help right away if you notice any symptoms||
7268|118|S|of a serious allergic reaction, including: rash, itching/swelling||
7268|119|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7268|120|S|breathing.||
7268|121|S|   This is not a complete list of possible side effects. If you||
7268|122|S|notice other effects not listed above, contact your doctor or||
7268|123|S|pharmacist.||
7268|124|S|   In the US -||
7268|125|S|   Call your doctor for medical advice about side effects. You||
7268|126|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7268|127|S|www.fda.gov/medwatch.||
7268|128|S|   In Canada - Call your doctor for medical advice about side||
7268|129|S|effects. You may report side effects to Health Canada at||
7268|130|S|1-866-234-2345.||
7268|131|B|||
7268|132|P|PRECAUTIONS:  Before taking lamivudine, tell your doctor or||
7268|133|P|pharmacist if you are allergic to it; or if you have any other||
7268|134|P|allergies. This product may contain inactive ingredients, which||
7268|135|P|can cause allergic reactions or other problems. Talk to your||
7268|136|P|pharmacist for more details.||
7268|137|P|   Before using this medication, tell your doctor or pharmacist||
7268|138|P|your medical history, especially of: pancreatitis, kidney||
7268|139|P|problems, liver problems (such as hepatitis B or C, cirrhosis),||
7268|140|P|alcohol use.||
7268|141|P|   Avoid alcoholic beverages because they may increase your risk||
7268|142|P|for liver problems and/or pancreatitis.||
7268|143|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7268|144|P|can make you more dizzy. Do not drive, use machinery, or do||
7268|145|P|anything that needs alertness until you can do it safely. Avoid||
7268|146|P|alcoholic beverages. Talk to your doctor if you are using||
7268|147|P|marijuana (cannabis).||
7268|148|P|   Before having surgery, tell your doctor or dentist about all||
7268|149|P|the products you use (including prescription drugs,||
7268|150|P|nonprescription drugs, and herbal products).||
7268|151|P|   This product may contain sugar. Caution is advised if you have||
7268|152|P|diabetes or any other condition that requires you to limit sugar||
7268|153|P|in your diet. Ask your doctor or pharmacist about using this||
7268|154|P|product safely.||
7268|155|P|   Children may be more sensitive to the side effects of this||
7268|156|P|drug, especially the increased risk of pancreatitis.||
7268|157|P|   Tell your doctor if you are pregnant before using this||
7268|158|P|medication. Treatment can lower the risk of passing HIV infection||
7268|159|P|to your baby. Discuss the risks and benefits with your doctor.||
7268|160|P|   This medication passes into breast milk. Because breast milk||
7268|161|P|may transmit HIV, consult your doctor before breastfeeding.||
7268|162|B|||
7268|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7268|164|I|medications work or increase your risk for serious side effects.||
7268|165|I|This document does not contain all possible drug interactions.||
7268|166|I|Keep a list of all the products you use (including||
7268|167|I|prescription/nonprescription drugs and herbal products) and share||
7268|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
7268|169|I|the dosage of any medicines without your doctor's approval.||
7268|170|I|   Some products that may interact with this drug are: orlistat,||
7268|171|I|products containing sorbitol.||
7268|172|I|   Emtricitabine is similar to lamivudine and should not be taken||
7268|173|I|with this medication. Check the labels on all your HIV medicines||
7268|174|I|because they may contain the same ingredients as found in this||
7268|175|I|product. Taking too much of these drugs will not necessarily||
7268|176|I|improve your condition, and may cause more side effects.||
7268|177|B|||
7268|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7268|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7268|180|O|poison control center right away. US residents can call||
7268|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7268|182|B|||
7268|183|N|NOTES:  Do not share this medication with others.||
7268|184|N|   Lab and/or medical tests (such as kidney function, liver||
7268|185|N|tests, viral load, T-cell counts) should be done while you are||
7268|186|N|taking this medication. Keep all medical and lab appointments.||
7268|187|N|Consult your doctor for more details.||
7268|188|B|||
7268|189|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7268|190|D|remember. If it is near the time of the next dose, skip the||
7268|191|D|missed dose. Take your next dose at the regular time. Do not||
7268|192|D|double the dose to catch up.||
7268|193|B|||
7268|194|R|STORAGE:  Different brands of this medication have different||
7268|195|R|storage needs. Check the product package for instructions on how||
7268|196|R|to store your brand, or ask your pharmacist. Keep all medications||
7268|197|R|away from children and pets.||
7268|198|R|   Do not flush medications down the toilet or pour them into a||
7268|199|R|drain unless instructed to do so. Properly discard this product||
7268|200|R|when it is expired or no longer needed. Consult your pharmacist||
7268|201|R|or local waste disposal company.||
7268|202|B|||
7268|203|A|Information last revised April 2025.||
7268|204|A|Copyright(c) 2025 First Databank, Inc.||
7268|205|B|||
7269|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7269|002|Z|does NOT have all possible information about this product. This||
7269|003|Z|information does not assure that this product is safe, effective,||
7269|004|Z|or appropriate for you. This information is not individual||
7269|005|Z|medical advice and does not substitute for the advice of your||
7269|006|Z|health care professional. Always ask your health care||
7269|007|Z|professional for complete information about this product and your||
7269|008|Z|specific health needs.||
7269|009|B|||
7269|010|T|CEFIXIME SUSPENSION - ORAL||
7269|011|F|(seff-ICKS-eem)||
7269|012|B|||
7269|013|C|COMMON BRAND NAME(S): Suprax||
7269|014|B|||
7269|015|U|USES:  Cefixime is used to treat a wide variety of bacterial||
7269|016|U|infections. This medication is known as a cephalosporin||
7269|017|U|antibiotic. It works by stopping the growth of bacteria.||
7269|018|U|   This antibiotic treats only bacterial infections. It will not||
7269|019|U|work for viral infections (such as common cold, flu). Using any||
7269|020|U|antibiotic when it is not needed can cause it to not work for||
7269|021|U|future infections.||
7269|022|B|||
7269|023|H|HOW TO USE:  Take this medication by mouth with or without food||
7269|024|H|as directed by your doctor, usually once a day. In children, this||
7269|025|H|medication may also be taken twice a day (every 12 hours). The||
7269|026|H|dosage is based on your medical condition and response to||
7269|027|H|treatment. Children's dosage is also based on weight.||
7269|028|H|   Shake the bottle well before each dose. Carefully measure the||
7269|029|H|dose using a special measuring device/spoon. Do not use a||
7269|030|H|household spoon because you may not get the correct dose.||
7269|031|H|   For the best effect, take this antibiotic at evenly spaced||
7269|032|H|times. To help you remember, take this medication at the same||
7269|033|H|time(s) every day.||
7269|034|H|   Continue to use this medication until the full prescribed||
7269|035|H|amount is finished, even if symptoms disappear after a few days.||
7269|036|H|Stopping the medication too early may result in a return of the||
7269|037|H|infection.||
7269|038|H|   Tell your doctor if your condition lasts or gets worse.||
7269|039|B|||
7269|040|S|SIDE EFFECTS:  Stomach upset/pain, diarrhea, nausea, gas,||
7269|041|S|headache, or dizziness may occur. If any of these effects last or||
7269|042|S|get worse, tell your doctor or pharmacist promptly.||
7269|043|S|   Remember that this medication has been prescribed because your||
7269|044|S|doctor has judged that the benefit to you is greater than the||
7269|045|S|risk of side effects. Many people using this medication do not||
7269|046|S|have serious side effects.||
7269|047|S|   Tell your doctor right away if you have any serious side||
7269|048|S|effects, including: nausea/vomiting that doesn't stop, severe||
7269|049|S|stomach/abdominal pain, yellowing eyes/skin, dark urine, unusual||
7269|050|S|tiredness, new signs of infection (such as sore throat that||
7269|051|S|doesn't go away, fever, chills), easy bruising/bleeding, signs of||
7269|052|S|kidney problems (such as change in the amount of urine),||
7269|053|S|mental/mood changes (such as confusion).||
7269|054|S|   This medication may rarely cause a severe intestinal condition||
7269|055|S|due to a bacteria called C. difficile. This condition may occur||
7269|056|S|during treatment or weeks to months after treatment has stopped.||
7269|057|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7269|058|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7269|059|S|stool.||
7269|060|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7269|061|S|products because they may make symptoms worse.||
7269|062|S|   Use of this medication for prolonged or repeated periods may||
7269|063|S|result in oral thrush or a new vaginal yeast infection (oral or||
7269|064|S|vaginal fungal infection). Contact your doctor if you notice||
7269|065|S|white patches in your mouth, a change in vaginal discharge, or||
7269|066|S|other new symptoms.||
7269|067|S|   A very serious allergic reaction to this drug is rare.||
7269|068|S|However, get medical help right away if you notice any symptoms||
7269|069|S|of a serious allergic reaction, including: rash, itching/swelling||
7269|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7269|071|S|breathing.||
7269|072|S|   This is not a complete list of possible side effects. If you||
7269|073|S|notice other effects not listed above, contact your doctor or||
7269|074|S|pharmacist.||
7269|075|S|   In the US -||
7269|076|S|   Call your doctor for medical advice about side effects. You||
7269|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7269|078|S|www.fda.gov/medwatch.||
7269|079|S|   In Canada - Call your doctor for medical advice about side||
7269|080|S|effects. You may report side effects to Health Canada at||
7269|081|S|1-866-234-2345.||
7269|082|B|||
7269|083|P|PRECAUTIONS:  Before taking cefixime, tell your doctor or||
7269|084|P|pharmacist if you are allergic to it; or to penicillins or other||
7269|085|P|cephalosporin antibiotics (such as cephalexin); or if you have||
7269|086|P|any other allergies. This product may contain inactive||
7269|087|P|ingredients, which can cause allergic reactions or other||
7269|088|P|problems. Talk to your pharmacist for more details.||
7269|089|P|   Before using this medication, tell your doctor or pharmacist||
7269|090|P|your medical history, especially of: kidney disease, a certain||
7269|091|P|intestinal disease (colitis).||
7269|092|P|   Cefixime may cause live bacterial vaccines (such as typhoid||
7269|093|P|vaccine) to not work well. Tell your health care professional||
7269|094|P|that you are using cefixime before having any||
7269|095|P|immunizations/vaccinations.||
7269|096|P|   Before having surgery, tell your doctor or dentist about all||
7269|097|P|the products you use (including prescription drugs,||
7269|098|P|nonprescription drugs, and herbal products).||
7269|099|P|   During pregnancy, this medication should be used only when||
7269|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
7269|101|P|   It is unknown if this medication passes into breast milk.||
7269|102|P|Consult your doctor before breastfeeding.||
7269|103|B|||
7269|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7269|105|I|medications work or increase your risk for serious side effects.||
7269|106|I|This document does not contain all possible drug interactions.||
7269|107|I|Keep a list of all the products you use (including||
7269|108|I|prescription/nonprescription drugs and herbal products) and share||
7269|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
7269|110|I|the dosage of any medicines without your doctor's approval.||
7269|111|I|   Products that may interact with this drug include: "blood||
7269|112|I|thinners" (such as warfarin).||
7269|113|I|   This medication may interfere with certain lab tests (such as||
7269|114|I|certain diabetic urine tests), possibly causing false test||
7269|115|I|results. Make sure lab personnel and all your doctors know you||
7269|116|I|use this drug.||
7269|117|B|||
7269|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7269|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7269|120|O|poison control center right away. US residents can call||
7269|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7269|122|O|Symptoms of overdose may include: severe vomiting, seizures.||
7269|123|B|||
7269|124|N|NOTES:  Do not share this medication with others.||
7269|125|N|   This medication has been prescribed for your current condition||
7269|126|N|only. Do not use it later for another infection unless your||
7269|127|N|doctor tells you to.||
7269|128|B|||
7269|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7269|130|D|remember. If it is near the time of the next dose, skip the||
7269|131|D|missed dose. Take your next dose at the regular time. Do not||
7269|132|D|double the dose to catch up.||
7269|133|B|||
7269|134|R|STORAGE:  Store at room temperature or in the refrigerator.||
7269|135|R|Discard any unused portion after 14 days. Keep all medications||
7269|136|R|away from children and pets.||
7269|137|R|   Do not flush medications down the toilet or pour them into a||
7269|138|R|drain unless instructed to do so. Properly discard this product||
7269|139|R|when it is expired or no longer needed. Consult your pharmacist||
7269|140|R|or local waste disposal company.||
7269|141|B|||
7269|142|A|Information last revised May 2025.||
7269|143|A|Copyright(c) 2025 First Databank, Inc.||
7269|144|B|||
7271|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7271|002|Z|does NOT have all possible information about this product. This||
7271|003|Z|information does not assure that this product is safe, effective,||
7271|004|Z|or appropriate for you. This information is not individual||
7271|005|Z|medical advice and does not substitute for the advice of your||
7271|006|Z|health care professional. Always ask your health care||
7271|007|Z|professional for complete information about this product and your||
7271|008|Z|specific health needs.||
7271|009|B|||
7271|010|T|TINZAPARIN - INJECTION||
7271|011|F|(TIN-za-PAR-in)||
7271|012|B|||
7271|013|C|COMMON BRAND NAME(S): Innohep||
7271|014|B|||
7271|015|W|WARNING:  People using this medication may bleed near the spinal||
7271|016|W|cord after certain spinal procedures. Bleeding in this area can||
7271|017|W|cause paralysis that lasts a long time or could become permanent.||
7271|018|W|Talk with your doctor about the benefits and risks before any||
7271|019|W|spinal procedure. Your doctor may direct you to stop this||
7271|020|W|medication for a certain amount of time before and after the||
7271|021|W|procedure. Carefully follow your doctor's directions.||
7271|022|W|   The risk of bleeding may be higher if you have a deformed||
7271|023|W|spine, or have had spinal procedures/surgery before (such as||
7271|024|W|epidural catheter placement, difficult epidural/spinal puncture),||
7271|025|W|or are taking other drugs that can cause bleeding/bruising||
7271|026|W|(including antiplatelet drugs such as clopidogrel, "blood||
7271|027|W|thinners" such as warfarin/rivaroxaban, nonsteroidal||
7271|028|W|anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your||
7271|029|W|doctor right away if you notice symptoms such as back pain, leg||
7271|030|W|numbness/tingling/weakness, loss of control of the bowels or||
7271|031|W|bladder (incontinence).||
7271|032|B|||
7271|033|U|USES:  Tinzaparin is used to treat serious blood clots, usually||
7271|034|U|in the legs. Tinzaparin may also be used to treat blood clots in||
7271|035|U|the lungs. It is usually used with another "blood thinner"||
7271|036|U|medication (warfarin). If untreated, blood clots can travel to||
7271|037|U|the lungs, heart, or brain, causing serious (possibly fatal)||
7271|038|U|breathing problems, heart attack, or stroke.||
7271|039|U|   This drug may also be used to prevent blood clots after||
7271|040|U|certain surgeries with an increased risk of blood clots (such as||
7271|041|U|knee or hip replacement). It may also be used to prevent clotting||
7271|042|U|in certain catheters used by patients on hemodialysis.||
7271|043|U|   Tinzaparin is known as a "blood thinner" (anticoagulant). It||
7271|044|U|is a type of heparin called low-molecular-weight heparin. It||
7271|045|U|works by blocking certain natural substances in the blood that||
7271|046|U|cause clotting.||
7271|047|B|||
7271|048|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7271|049|H|from your pharmacist before you start using tinzaparin and each||
7271|050|H|time you get a refill. Ask your health care professional how to||
7271|051|H|prepare and use this medication. If you have any questions, ask||
7271|052|H|your doctor or pharmacist.||
7271|053|H|   Inject this medication under the skin as directed by your||
7271|054|H|doctor, usually once daily. The injection is given in the||
7271|055|H|stomach/abdomen. Do not inject into a muscle. The dosage and||
7271|056|H|length of treatment are based on your medical condition, weight,||
7271|057|H|and response to treatment.||
7271|058|H|   Before using, check this product for particles or||
7271|059|H|discoloration. If either is present, do not use the liquid. Do||
7271|060|H|not mix any other medication in the same injection. Before||
7271|061|H|injecting each dose, clean the skin you are going to inject into||
7271|062|H|(the injection site) with rubbing alcohol. Change the injection||
7271|063|H|site each time to lessen injury under the skin. To lessen||
7271|064|H|bruising, do not rub the injection site after a shot. Learn how||
7271|065|H|to store and discard medical supplies safely.||
7271|066|H|   When treating a blood clot, another "blood thinner" (warfarin)||
7271|067|H|is usually started 1 to 3 days after you start using tinzaparin.||
7271|068|H|Your doctor will direct you to use both of these medications||
7271|069|H|until the warfarin is working well. Do not stop either of these||
7271|070|H|medications until your doctor directs you to stop.||
7271|071|H|   To prevent blood clots due to surgery, your doctor may direct||
7271|072|H|you to start using this medication before or after surgery and||
7271|073|H|continue for several days. Follow your doctor's directions||
7271|074|H|closely.||
7271|075|H|   This medication may also be given by injection into a vein (to||
7271|076|H|prevent clotting of certain hemodialysis catheters) by a health||
7271|077|H|care professional as directed by your doctor.||
7271|078|H|   Use this medication regularly to get the most benefit from it.||
7271|079|H|To help you remember, use it at the same time each day.||
7271|080|B|||
7271|081|S|SIDE EFFECTS:  Pain, bruising, redness, and swelling at the||
7271|082|S|injection site may occur. Headache, nosebleed, and fever may also||
7271|083|S|occur. If any of these effects last or get worse, tell your||
7271|084|S|doctor or pharmacist promptly.||
7271|085|S|   Remember that this medication has been prescribed because your||
7271|086|S|doctor has judged that the benefit to you is greater than the||
7271|087|S|risk of side effects. Many people using this medication do not||
7271|088|S|have serious side effects.||
7271|089|S|   Tell your doctor right away if you have any serious side||
7271|090|S|effects, including: nausea/vomiting that doesn't stop, loss of||
7271|091|S|appetite, easy bleeding/bruising, dark urine, yellowing||
7271|092|S|eyes/skin.||
7271|093|S|   This medication may rarely cause serious bleeding. (See also||
7271|094|S|Warning section.) Tell your doctor right away if you have any||
7271|095|S|signs of serious bleeding, including: shortness of breath,||
7271|096|S|coughing up blood, chest pain, cold/blue fingers or toes, unusual||
7271|097|S|dizziness, fast/irregular heartbeat, joint/muscle pain,||
7271|098|S|mental/mood changes (such as confusion), difficulty moving,||
7271|099|S|numbness/tingling, severe stomach/abdominal pain,||
7271|100|S|bloody/black/tarry stools, red/pinkish urine, vomit that looks||
7271|101|S|like coffee grounds.||
7271|102|S|   Get medical help right away if you have any very serious side||
7271|103|S|effects, including: headache that is severe or doesn't go away,||
7271|104|S|seizures, fainting, trouble speaking, vision problems, weakness||
7271|105|S|on one side of the body.||
7271|106|S|   Rarely, males may have a painful or prolonged erection lasting||
7271|107|S|4 or more hours. If this occurs, stop using this drug and get||
7271|108|S|medical help right away, or permanent problems could occur.||
7271|109|S|   A very serious allergic reaction to this drug is rare.||
7271|110|S|However, get medical help right away if you notice any symptoms||
7271|111|S|of a serious allergic reaction, including: rash, itching/swelling||
7271|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7271|113|S|breathing.||
7271|114|S|   This is not a complete list of possible side effects. If you||
7271|115|S|notice other effects not listed above, contact your doctor or||
7271|116|S|pharmacist.||
7271|117|S|   In the US -||
7271|118|S|   Call your doctor for medical advice about side effects. You||
7271|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7271|120|S|www.fda.gov/medwatch.||
7271|121|S|   In Canada - Call your doctor for medical advice about side||
7271|122|S|effects. You may report side effects to Health Canada at||
7271|123|S|1-866-234-2345.||
7271|124|B|||
7271|125|P|PRECAUTIONS:  See also Warning section.||
7271|126|P|   Before using tinzaparin, tell your doctor or pharmacist if you||
7271|127|P|are allergic to it; or to heparin or pork products; or if you||
7271|128|P|have any other allergies. This product may contain inactive||
7271|129|P|ingredients (such as sulfites, benzyl alcohol), which can cause||
7271|130|P|allergic reactions or other problems. Talk to your pharmacist for||
7271|131|P|more details.||
7271|132|P|   Before using tinzaparin, tell your doctor or pharmacist your||
7271|133|P|medical history, especially of: a past blood-clotting problem||
7271|134|P|because of heparin (heparin-induced thrombocytopenia), artificial||
7271|135|P|heart valves, bleeding/blood problems (such as low platelet||
7271|136|P|count, bleeding ulcer), a certain eye problem (diabetic||
7271|137|P|retinopathy), high blood pressure, infections in the heart||
7271|138|P|(bacterial endocarditis), kidney disease, liver disease,||
7271|139|P|stomach/intestinal problems (such as recent ulcers, colitis),||
7271|140|P|stroke, recent spinal procedures or puncture, spine problems||
7271|141|P|(such as spinal deformity), recent surgery (especially on the||
7271|142|P|eye, brain, or spine).||
7271|143|P|   Before having surgery, tell your doctor or dentist about all||
7271|144|P|the products you use (including prescription drugs,||
7271|145|P|nonprescription drugs, and herbal products).||
7271|146|P|   Limit alcohol while taking this drug because it may increase||
7271|147|P|the risk of stomach bleeding.||
7271|148|P|   To lower the chance of getting cut, bruised, or injured, use||
7271|149|P|caution with sharp objects like razors and nail cutters, and||
7271|150|P|avoid activities such as contact sports.||
7271|151|P|   Older adults may be more sensitive to the side effects of this||
7271|152|P|drug, especially bleeding.||
7271|153|P|   During pregnancy, this medication should be used only when||
7271|154|P|clearly needed. Discuss the risks and benefits with your doctor.||
7271|155|P|If you become pregnant or think you may be pregnant, tell your||
7271|156|P|doctor right away. Since the benzyl alcohol in tinzaparin can||
7271|157|P|affect the unborn baby, a preservative-free product should be||
7271|158|P|used by pregnant women if possible.||
7271|159|P|   It is unknown if this drug passes into breast milk. Consult||
7271|160|P|your doctor before breastfeeding.||
7271|161|B|||
7271|162|I|DRUG INTERACTIONS:  See also Warning section.||
7271|163|I|   Drug interactions may change how your medications work or||
7271|164|I|increase your risk for serious side effects. This document does||
7271|165|I|not contain all possible drug interactions. Keep a list of all||
7271|166|I|the products you use (including prescription/nonprescription||
7271|167|I|drugs and herbal products) and share it with your doctor and||
7271|168|I|pharmacist. Do not start, stop, or change the dosage of any||
7271|169|I|medicines without your doctor's approval.||
7271|170|I|   Some products that may interact with this drug include:||
7271|171|I|mifepristone, other drugs that can cause bleeding/bruising||
7271|172|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
7271|173|I|ketorolac, "blood thinners" such as dabigatran).||
7271|174|I|   Check all prescription and nonprescription medicine labels||
7271|175|I|carefully since many medications contain pain relievers/fever||
7271|176|I|reducers (NSAIDs such as ibuprofen, naproxen, aspirin) which can||
7271|177|I|increase the risk of bleeding when used with tinzaparin. However,||
7271|178|I|if your doctor has told you to take low-dose aspirin to prevent||
7271|179|I|heart attack or stroke (usually 81-162 milligrams a day), you||
7271|180|I|should keep taking the aspirin unless your doctor tells you not||
7271|181|I|to. Ask your doctor or pharmacist for more details.||
7271|182|B|||
7271|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7271|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7271|185|O|poison control center right away. US residents can call||
7271|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7271|187|O|Symptoms of overdose may include: bleeding that doesn't stop.||
7271|188|B|||
7271|189|N|NOTES:  Do not share this medication with others.||
7271|190|N|   Lab and/or medical tests (such as complete blood count,||
7271|191|N|kidney/liver function) should be done while you are using this||
7271|192|N|medication. Keep all medical and lab appointments. Consult your||
7271|193|N|doctor for more details.||
7271|194|B|||
7271|195|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7271|196|D|If it is near the time of the next dose, skip the missed dose.||
7271|197|D|Use your next dose at the regular time. Do not double the dose to||
7271|198|D|catch up.||
7271|199|B|||
7271|200|R|STORAGE:  Store at room temperature. Keep all medications away||
7271|201|R|from children and pets.||
7271|202|R|   Do not flush medications down the toilet or pour them into a||
7271|203|R|drain unless instructed to do so. Properly discard this product||
7271|204|R|when it is expired or no longer needed. Consult your pharmacist||
7271|205|R|or local waste disposal company.||
7271|206|B|||
7271|207|M|MEDICAL ALERT:  Your condition can cause complications in a||
7271|208|M|medical emergency. For information about enrolling in MedicAlert,||
7271|209|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7271|210|B|||
7271|211|A|Information last revised December 2024.||
7271|212|A|Copyright(c) 2025 First Databank, Inc.||
7271|213|B|||
7272|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7272|002|Z|does NOT have all possible information about this product. This||
7272|003|Z|information does not assure that this product is safe, effective,||
7272|004|Z|or appropriate for you. This information is not individual||
7272|005|Z|medical advice and does not substitute for the advice of your||
7272|006|Z|health care professional. Always ask your health care||
7272|007|Z|professional for complete information about this product and your||
7272|008|Z|specific health needs.||
7272|009|B|||
7272|010|T|GEMCITABINE - INJECTION||
7272|011|F|(jem-SYE-ta-been)||
7272|012|B|||
7272|013|C|COMMON BRAND NAME(S): Gemzar||
7272|014|B|||
7272|015|U|USES:  Gemcitabine is used to treat certain types of cancer||
7272|016|U|(including biliary tract, breast, lung, ovarian, pancreatic). It||
7272|017|U|is a chemotherapy drug that works by slowing or stopping the||
7272|018|U|growth of cancer cells.||
7272|019|B|||
7272|020|V|OTHER USES:  This section contains uses of this drug that are not||
7272|021|V|listed in the approved professional labeling for the drug but||
7272|022|V|that may be prescribed by your health care professional. Use this||
7272|023|V|drug for a condition that is listed in this section only if it||
7272|024|V|has been so prescribed by your health care professional.||
7272|025|V|   This drug may also be used for other types of cancer (such as||
7272|026|V|bladder).||
7272|027|B|||
7272|028|H|HOW TO USE:  This medication is given by injection into a vein by||
7272|029|H|a healthcare professional. It is given over 30 minutes as||
7272|030|H|directed by your doctor. The dosage is based on your medical||
7272|031|H|condition, body size, and response to treatment.||
7272|032|B|||
7272|033|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, mouth sores,||
7272|034|S|drowsiness, muscle aches, and pain/redness/swelling at the||
7272|035|S|injection site may occur. If any of these effects last or get||
7272|036|S|worse, tell your doctor or pharmacist promptly.||
7272|037|S|   Temporary hair loss may occur. Normal hair growth should||
7272|038|S|return after treatment has ended.||
7272|039|S|   People using this medication may have serious side effects.||
7272|040|S|However, you have been prescribed this drug because your doctor||
7272|041|S|has judged that the benefit to you is greater than the risk of||
7272|042|S|side effects. Careful monitoring by your doctor may decrease your||
7272|043|S|risk.||
7272|044|S|   Tell your doctor right away if you have any serious side||
7272|045|S|effects, including: signs of lung problems (such as shortness of||
7272|046|S|breath, cough), dizziness/lightheadedness, fainting, swelling||
7272|047|S|ankles/feet/hands, numb/tingling skin, fast/slow/irregular||
7272|048|S|heartbeat, signs of kidney problems (such as change in the amount||
7272|049|S|of urine, bloody urine), signs of liver disease (such as||
7272|050|S|yellowing eyes/skin, dark urine, stomach/abdominal pain).||
7272|051|S|   Get medical help right away if you have any very serious side||
7272|052|S|effects, including: chest/jaw/left arm pain, severe headache,||
7272|053|S|trouble speaking, weakness on one side of the body, vision||
7272|054|S|changes, mental/mood changes (such as confusion), seizures.||
7272|055|S|   This medication may decrease bone marrow function, an effect||
7272|056|S|that may lead to a low number of blood cells such as red cells,||
7272|057|S|white cells, and platelets. This effect can cause anemia,||
7272|058|S|decrease your body's ability to fight an infection, or cause easy||
7272|059|S|bruising/bleeding. Get medical help right away if you develop any||
7272|060|S|of the following symptoms: unusual tiredness, pale skin, signs of||
7272|061|S|infection (such as sore throat that doesn't go away, fever,||
7272|062|S|swollen lymph nodes, chills), easy bruising/bleeding.||
7272|063|S|   A very serious allergic reaction to this drug is rare.||
7272|064|S|However, get medical help right away if you notice any symptoms||
7272|065|S|of a serious allergic reaction, including: rash, itching/swelling||
7272|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7272|067|S|breathing.||
7272|068|S|   This is not a complete list of possible side effects. If you||
7272|069|S|notice other effects not listed above, contact your doctor or||
7272|070|S|pharmacist.||
7272|071|S|   In the US -||
7272|072|S|   Call your doctor for medical advice about side effects. You||
7272|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7272|074|S|www.fda.gov/medwatch.||
7272|075|S|   In Canada - Call your doctor for medical advice about side||
7272|076|S|effects. You may report side effects to Health Canada at||
7272|077|S|1-866-234-2345.||
7272|078|B|||
7272|079|P|PRECAUTIONS:  Before using gemcitabine, tell your doctor or||
7272|080|P|pharmacist if you are allergic to it; or if you have any other||
7272|081|P|allergies. This product may contain inactive ingredients, which||
7272|082|P|can cause allergic reactions or other problems. Talk to your||
7272|083|P|pharmacist for more details.||
7272|084|P|   Before using this medication, tell your doctor or pharmacist||
7272|085|P|your medical history, especially of: liver disease, kidney||
7272|086|P|disease, radiation treatment, heart problems (such as irregular||
7272|087|P|heartbeat, heart failure).||
7272|088|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
7272|089|P|can make you more drowsy. Do not drive, use machinery, or do||
7272|090|P|anything that needs alertness until you can do it safely. Limit||
7272|091|P|alcoholic beverages. Talk to your doctor if you are using||
7272|092|P|marijuana (cannabis).||
7272|093|P|   Before having surgery, tell your doctor or dentist about all||
7272|094|P|the products you use (including prescription drugs,||
7272|095|P|nonprescription drugs, and herbal products).||
7272|096|P|   Gemcitabine can make you more likely to get infections or may||
7272|097|P|make current infections worse. Stay away from anyone who has an||
7272|098|P|infection that may easily spread (such as chickenpox, COVID-19,||
7272|099|P|measles, flu). Talk to your doctor if you have been exposed to an||
7272|100|P|infection or for more details.||
7272|101|P|   Tell your health care professional that you are using||
7272|102|P|gemcitabine before having any immunizations/vaccinations. Avoid||
7272|103|P|contact with people who have recently received live vaccines||
7272|104|P|(such as flu vaccine inhaled through the nose).||
7272|105|P|   To lower the chance of getting cut, bruised, or injured, use||
7272|106|P|caution with sharp objects like razors and nail cutters, and||
7272|107|P|avoid activities such as contact sports.||
7272|108|P|   Older female adults are more sensitive to the side effects of||
7272|109|P|this medication, especially the risk of infection and easy||
7272|110|P|bruising/bleeding.||
7272|111|P|   Tell your doctor if you are pregnant or plan to become||
7272|112|P|pregnant. You should not become pregnant while using gemcitabine.||
7272|113|P|Gemcitabine may harm an unborn baby. Your doctor should order a||
7272|114|P|pregnancy test before you start this medication. Women using this||
7272|115|P|medication should ask about reliable forms of birth control||
7272|116|P|during treatment and for 6 months after the last dose. Men using||
7272|117|P|this medication should ask about reliable forms of birth control||
7272|118|P|during treatment and for 3 months after the last dose. If you or||
7272|119|P|your partner becomes pregnant, talk to your doctor right away||
7272|120|P|about the risks and benefits of this medication.||
7272|121|P|   It is unknown if this medication passes into breast milk.||
7272|122|P|Because of the possible risk to the infant, breastfeeding is not||
7272|123|P|recommended while using this medication and for 1 week after the||
7272|124|P|last dose. Consult your doctor before breastfeeding.||
7272|125|B|||
7272|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7272|127|I|medications work or increase your risk for serious side effects.||
7272|128|I|This document does not contain all possible drug interactions.||
7272|129|I|Keep a list of all the products you use (including||
7272|130|I|prescription/nonprescription drugs and herbal products) and share||
7272|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
7272|132|I|the dosage of any medicines without your doctor's approval.||
7272|133|B|||
7272|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7272|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7272|136|O|poison control center right away. US residents can call||
7272|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7272|138|B|||
7272|139|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
7272|140|N|liver/kidney function, blood pressure) should be done while you||
7272|141|N|are using this medication. Keep all medical and lab appointments.||
7272|142|N|Consult your doctor for more details.||
7272|143|B|||
7272|144|D|MISSED DOSE:  It is important to get each dose of this medication||
7272|145|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7272|146|D|right away for a new dosing schedule.||
7272|147|B|||
7272|148|R|STORAGE:  Not applicable. This medication is given in a clinic||
7272|149|R|and will not be stored at home.||
7272|150|B|||
7272|151|M|MEDICAL ALERT:  Your condition can cause complications in a||
7272|152|M|medical emergency. For information about enrolling in MedicAlert,||
7272|153|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7272|154|B|||
7272|155|A|Information last revised June 2024.||
7272|156|A|Copyright(c) 2025 First Databank, Inc.||
7272|157|B|||
7273|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7273|002|Z|does NOT have all possible information about this product. This||
7273|003|Z|information does not assure that this product is safe, effective,||
7273|004|Z|or appropriate for you. This information is not individual||
7273|005|Z|medical advice and does not substitute for the advice of your||
7273|006|Z|health care professional. Always ask your health care||
7273|007|Z|professional for complete information about this product and your||
7273|008|Z|specific health needs.||
7273|009|B|||
7273|010|T|TOREMIFENE - ORAL||
7273|011|F|(tor-EM-eh-feen)||
7273|012|B|||
7273|013|C|COMMON BRAND NAME(S): Fareston||
7273|014|B|||
7273|015|W|WARNING:  Toremifene has caused very serious (possibly fatal)||
7273|016|W|heart rhythm problems (QT prolongation in the EKG, torsades de||
7273|017|W|pointes). Get medical help right away if any of these rare but||
7273|018|W|serious side effects occur: fast/irregular heartbeat, seizures,||
7273|019|W|severe dizziness, or fainting. The risk of QT prolongation may be||
7273|020|W|increased if you have certain medical conditions or are taking||
7273|021|W|other drugs that may affect the heart rhythm. Before using||
7273|022|W|toremifene, tell your doctor or pharmacist of all the drugs you||
7273|023|W|take (see also Drug Interaction section) and if you have any of||
7273|024|W|the following conditions: certain heart problems (heart failure,||
7273|025|W|slow heartbeat, QT prolongation in the EKG), family history of||
7273|026|W|certain heart problems (QT prolongation in the EKG, sudden||
7273|027|W|cardiac death).||
7273|028|W|   Low levels of potassium or magnesium in the blood may also||
7273|029|W|increase your risk of QT prolongation. This risk may increase if||
7273|030|W|you use certain drugs (such as diuretics/"water pills") or if you||
7273|031|W|have conditions such as severe sweating, diarrhea, or vomiting.||
7273|032|W|Talk to your doctor about using toremifene safely.||
7273|033|B|||
7273|034|U|USES:  Toremifene is used in postmenopausal women to treat breast||
7273|035|U|cancer. It is usually used to treat cancer that needs estrogen, a||
7273|036|U|hormone, in order to grow (estrogen-receptor positive).||
7273|037|U|Toremifene is a nonsteroidal antiestrogen that blocks the effects||
7273|038|U|of estrogen in the breast tissue, thereby slowing or stopping the||
7273|039|U|growth of cancer.||
7273|040|B|||
7273|041|H|HOW TO USE:  Take this medication by mouth with or without food||
7273|042|H|as directed by your doctor, usually once daily. The dosage is||
7273|043|H|based on your medical condition and response to treatment.||
7273|044|H|   Use this medication regularly to get the most benefit from it.||
7273|045|H|To help you remember, take it at the same time each day.||
7273|046|H|   Avoid eating grapefruit or drinking grapefruit juice while||
7273|047|H|using this medication unless your doctor or pharmacist says you||
7273|048|H|may do so safely. Grapefruit can increase the chance of side||
7273|049|H|effects with this medicine. Ask your doctor or pharmacist for||
7273|050|H|more details.||
7273|051|H|   Since this drug can be absorbed through the skin and lungs,||
7273|052|H|women who are pregnant or who may become pregnant should not||
7273|053|H|handle this medication or breathe the dust from the tablets.||
7273|054|H|   Tell your doctor if your condition gets worse (such as you get||
7273|055|H|new breast lumps).||
7273|056|B|||
7273|057|S|SIDE EFFECTS:  See also Warning section.||
7273|058|S|   Hot flashes, sweating, nausea, vomiting, dry eyes, or||
7273|059|S|dizziness may occur. If any of these side effects last or get||
7273|060|S|worse, tell your doctor promptly.||
7273|061|S|   Remember that this medication has been prescribed because your||
7273|062|S|doctor has judged that the benefit to you is greater than the||
7273|063|S|risk of side effects. Many people using this medication do not||
7273|064|S|have serious side effects.||
7273|065|S|   Tell your doctor right away if you have any serious side||
7273|066|S|effects, including: bone/joint/muscle pain or swelling,||
7273|067|S|constipation, mental/mood changes (such as depression), trouble||
7273|068|S|walking/clumsiness, swelling ankles/feet, unusual tiredness,||
7273|069|S|vision changes (such as blurred vision, eye pain), easy||
7273|070|S|bleeding/bruising, signs of infection (such as sore throat that||
7273|071|S|doesn't go away, fever, chills), symptoms of liver disease (such||
7273|072|S|as nausea/vomiting that doesn't stop, loss of appetite,||
7273|073|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
7273|074|S|   Toremifene may increase your risk of uterine cancer. Tell your||
7273|075|S|doctor right away if you develop changes in menstrual period,||
7273|076|S|unusual vaginal bleeding/discharge or pain/pressure below your||
7273|077|S|"belly button" (navel).||
7273|078|S|   Toremifene may rarely cause serious (sometimes fatal) problems||
7273|079|S|from blood clots (such as heart attack, stroke, blood clots in||
7273|080|S|the lungs or legs). Get medical help right away if you have:||
7273|081|S|pain/swelling/warmth in the groin/calf, chest/jaw/left arm pain,||
7273|082|S|confusion, sudden dizziness/fainting, sudden/severe headaches,||
7273|083|S|trouble speaking, sudden vision changes, shortness of||
7273|084|S|breath/rapid breathing, unusual sweating, weakness on one side of||
7273|085|S|the body.||
7273|086|S|   A very serious allergic reaction to this drug is rare.||
7273|087|S|However, get medical help right away if you notice any symptoms||
7273|088|S|of a serious allergic reaction, including: rash, itching/swelling||
7273|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7273|090|S|breathing.||
7273|091|S|   This is not a complete list of possible side effects. If you||
7273|092|S|notice other effects not listed above, contact your doctor or||
7273|093|S|pharmacist.||
7273|094|S|   In the US -||
7273|095|S|   Call your doctor for medical advice about side effects. You||
7273|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7273|097|S|www.fda.gov/medwatch.||
7273|098|S|   In Canada - Call your doctor for medical advice about side||
7273|099|S|effects. You may report side effects to Health Canada at||
7273|100|S|1-866-234-2345.||
7273|101|B|||
7273|102|P|PRECAUTIONS:  See also Warning section.||
7273|103|P|   Before taking toremifene, tell your doctor or pharmacist if||
7273|104|P|you are allergic to it; or if you have any other allergies. This||
7273|105|P|product may contain inactive ingredients, which can cause||
7273|106|P|allergic reactions or other problems. Talk to your pharmacist for||
7273|107|P|more details.||
7273|108|P|   Before using this medication, tell your doctor or pharmacist||
7273|109|P|your medical history, especially of: bone cancer (metastases),||
7273|110|P|blood disorders (such as anemia, low platelets), diabetes,||
7273|111|P|stroke, blood clots (such as in the legs, lungs), heart disease||
7273|112|P|(such as heart attack, irregular heartbeat), high blood pressure,||
7273|113|P|liver disease, uterus problems such as endometrial hyperplasia.||
7273|114|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7273|115|P|can make you more dizzy. Do not drive, use machinery, or do||
7273|116|P|anything that needs alertness until you can do it safely. Limit||
7273|117|P|alcoholic beverages. Talk to your doctor if you are using||
7273|118|P|marijuana (cannabis).||
7273|119|P|   Tell your doctor if you will be having surgery or will be||
7273|120|P|confined to a chair/bed for a long time (such as on a long plane||
7273|121|P|flight).||
7273|122|P|   During pregnancy, toremifene should be used only when clearly||
7273|123|P|needed. It may harm an unborn baby. If you become pregnant or||
7273|124|P|think you may be pregnant, inform your doctor right away. Women||
7273|125|P|of childbearing age should use reliable forms of non-hormonal||
7273|126|P|birth control (such as condoms, diaphragm with spermicide) while||
7273|127|P|using this medication. Discuss the use of birth control, the||
7273|128|P|risks and benefits of this medication, and any other concerns||
7273|129|P|about using this medication with your doctor.||
7273|130|P|   It is unknown if this medication passes into breast milk.||
7273|131|P|Because of the possible risk to the infant, breastfeeding is not||
7273|132|P|recommended while using this medication. Consult your doctor||
7273|133|P|before breastfeeding.||
7273|134|B|||
7273|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7273|136|I|medications work or increase your risk for serious side effects.||
7273|137|I|This document does not contain all possible drug interactions.||
7273|138|I|Keep a list of all the products you use (including||
7273|139|I|prescription/nonprescription drugs and herbal products) and share||
7273|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
7273|141|I|the dosage of any medicines without your doctor's approval.||
7273|142|I|   Some products that may interact with this drug include: "blood||
7273|143|I|thinners" (such as warfarin), estrogens, tibolone.||
7273|144|I|   Many drugs besides toremifene may affect the heart rhythm (QT||
7273|145|I|prolongation), including amiodarone, granisetron, pimozide,||
7273|146|I|procainamide, quinidine, sotalol, and macrolide antibiotics (such||
7273|147|I|as erythromycin), among others.||
7273|148|I|   Other medications can affect the removal of toremifene from||
7273|149|I|your body, which may affect how toremifene works. Examples||
7273|150|I|include azole antifungals (such as ketoconazole), rifamycins||
7273|151|I|(such as rifabutin), drugs used to treat seizures (such as||
7273|152|I|carbamazepine, phenytoin, phenobarbital), St. John's Wort, among||
7273|153|I|others.||
7273|154|B|||
7273|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7273|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7273|157|O|poison control center right away. US residents can call||
7273|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7273|159|B|||
7273|160|N|NOTES:  Do not share this medication with others.||
7273|161|N|   Lab and/or medical tests (such as complete blood count,||
7273|162|N|calcium levels, liver function, pelvic exam) should be done||
7273|163|N|before you start taking this medication and while you are taking||
7273|164|N|it. Keep all medical and lab appointments. Consult your doctor||
7273|165|N|for more details.||
7273|166|B|||
7273|167|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7273|168|D|remember. If it is near the time of the next dose, skip the||
7273|169|D|missed dose. Take your next dose at the regular time. Do not||
7273|170|D|double the dose to catch up.||
7273|171|B|||
7273|172|R|STORAGE:  Store at room temperature away from light and moisture.||
7273|173|R|Do not store in the bathroom. Keep all medications away from||
7273|174|R|children and pets.||
7273|175|R|   Do not flush medications down the toilet or pour them into a||
7273|176|R|drain unless instructed to do so. Properly discard this product||
7273|177|R|when it is expired or no longer needed. Consult your pharmacist||
7273|178|R|or local waste disposal company.||
7273|179|B|||
7273|180|A|Information last revised November 2024.||
7273|181|A|Copyright(c) 2025 First Databank, Inc.||
7273|182|B|||
7274|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7274|002|Z|does NOT have all possible information about this product. This||
7274|003|Z|information does not assure that this product is safe, effective,||
7274|004|Z|or appropriate for you. This information is not individual||
7274|005|Z|medical advice and does not substitute for the advice of your||
7274|006|Z|health care professional. Always ask your health care||
7274|007|Z|professional for complete information about this product and your||
7274|008|Z|specific health needs.||
7274|009|B|||
7274|010|T|OLANZAPINE DISINTEGRATING TABLET - ORAL||
7274|011|F|(oh-LAN-za-peen)||
7274|012|B|||
7274|013|C|COMMON BRAND NAME(S): Zyprexa||
7274|014|B|||
7274|015|W|WARNING:  There may be a slightly increased risk of serious,||
7274|016|W|possibly fatal side effects (such as stroke, heart failure,||
7274|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
7274|018|W|by older adults with dementia. This medication is not approved||
7274|019|W|for the treatment of dementia-related behavior problems. Discuss||
7274|020|W|the risks and benefits of this medication, as well as other||
7274|021|W|effective and possibly safer treatments for dementia-related||
7274|022|W|behavior problems, with the doctor.||
7274|023|W|   If you are using olanzapine in combination with other||
7274|024|W|medication to treat depression, also carefully read the drug||
7274|025|W|information for the other medication.||
7274|026|B|||
7274|027|U|USES:  This medication is used to treat certain mental/mood||
7274|028|U|disorders (such as schizophrenia, bipolar disorder). It may also||
7274|029|U|be used in combination with other medication to treat depression.||
7274|030|U|Olanzapine belongs to a class of drugs known as atypical||
7274|031|U|antipsychotics. It works by helping to restore the balance of||
7274|032|U|certain natural substances in the brain.||
7274|033|U|   Talk to the doctor about the risks and benefits of treatment||
7274|034|U|(especially when used in teenagers). See also Precautions||
7274|035|U|section.||
7274|036|B|||
7274|037|V|OTHER USES:  This section contains uses of this drug that are not||
7274|038|V|listed in the approved professional labeling for the drug but||
7274|039|V|that may be prescribed by your health care professional. Use this||
7274|040|V|drug for a condition that is listed in this section only if it||
7274|041|V|has been so prescribed by your health care professional.||
7274|042|V|   This drug may also be used to reduce the risk of nausea and||
7274|043|V|vomiting caused by cancer drug treatment (chemotherapy).||
7274|044|B|||
7274|045|H|HOW TO USE:  Read the Medication Guide provided by your||
7274|046|H|pharmacist before you start taking olanzapine and each time you||
7274|047|H|get a refill. If you have any questions, ask your doctor or||
7274|048|H|pharmacist.||
7274|049|H|   Take this medication by mouth with or without food as directed||
7274|050|H|by your doctor, usually once daily.||
7274|051|H|   This medication comes in a blister or a bottle. Do not remove||
7274|052|H|the tablet from the packaging until you are ready to take it.||
7274|053|H|Make sure your hands are dry before handling the tablet. If your||
7274|054|H|tablet comes in a blister, peel back the foil to carefully remove||
7274|055|H|the tablet. Do not push the tablet through the foil because doing||
7274|056|H|so can damage the tablet. Place the tablet in your mouth right||
7274|057|H|away and allow it to dissolve. After the tablet has melted, it||
7274|058|H|can be swallowed with or without liquid.||
7274|059|H|   The dosage is based on your medical condition and response to||
7274|060|H|treatment. To reduce your risk of side effects, your doctor may||
7274|061|H|direct you to start this medication at a low dose and gradually||
7274|062|H|increase your dose. Follow your doctor's instructions carefully.||
7274|063|H|   Take this medication regularly to get the most benefit from||
7274|064|H|it. To help you remember, take it at the same time each day. Keep||
7274|065|H|taking this medication even if you feel well. Do not stop taking||
7274|066|H|this medication without consulting your doctor.||
7274|067|H|   Tell your doctor if your condition lasts or gets worse.||
7274|068|B|||
7274|069|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, stomach||
7274|070|S|upset, dry mouth, constipation, increased appetite, or weight||
7274|071|S|gain may occur. If any of these effects last or get worse, tell||
7274|072|S|your doctor or pharmacist promptly.||
7274|073|S|   Dizziness and lightheadedness can increase the risk of||
7274|074|S|falling. Get up slowly when rising from a sitting or lying||
7274|075|S|position.||
7274|076|S|   Remember that this medication has been prescribed because your||
7274|077|S|doctor has judged that the benefit to you is greater than the||
7274|078|S|risk of side effects. Many people using this medication do not||
7274|079|S|have serious side effects.||
7274|080|S|   Tell your doctor right away if you have any serious side||
7274|081|S|effects, including: difficulty swallowing, shaking (tremor), slow||
7274|082|S|heartbeat, fainting, mental/mood changes (such as confusion,||
7274|083|S|restlessness), numbness/tingling of arms/legs, yellowing||
7274|084|S|eyes/skin, severe stomach/abdominal pain, trouble urinating,||
7274|085|S|interrupted breathing during sleep.||
7274|086|S|   This drug may rarely make your blood sugar rise, which can||
7274|087|S|cause or worsen diabetes. Tell your doctor right away if you have||
7274|088|S|symptoms of high blood sugar such as increased thirst/urination.||
7274|089|S|If you already have diabetes, check your blood sugar regularly as||
7274|090|S|directed and share the results with your doctor. Your doctor may||
7274|091|S|need to adjust your diabetes medication, exercise program, or||
7274|092|S|diet.||
7274|093|S|   This drug may also cause significant weight gain and a rise in||
7274|094|S|your blood cholesterol (or triglyceride) levels, especially in||
7274|095|S|teenagers. These effects, along with diabetes, may increase your||
7274|096|S|risk for developing heart disease. Discuss the risks and benefits||
7274|097|S|of treatment with your doctor. (See also Notes section.)||
7274|098|S|   Olanzapine may rarely cause a condition known as tardive||
7274|099|S|dyskinesia. In some cases, this condition may be permanent. Tell||
7274|100|S|your doctor right away if you develop any unusual/uncontrolled||
7274|101|S|movements (especially of the face, lips, mouth, tongue, arms or||
7274|102|S|legs).||
7274|103|S|   This medication may increase a certain natural substance||
7274|104|S|(prolactin) made by your body. For females, this increase in||
7274|105|S|prolactin may result in unwanted breast milk, missed/stopped||
7274|106|S|periods, or difficulty becoming pregnant. For males, it may||
7274|107|S|result in decreased sexual ability, inability to produce sperm,||
7274|108|S|or enlarged breasts. If you develop any of these symptoms, tell||
7274|109|S|your doctor right away.||
7274|110|S|   Get medical help right away if you have any very serious side||
7274|111|S|effects, including: seizures.||
7274|112|S|   This medication may rarely cause a very serious condition||
7274|113|S|called neuroleptic malignant syndrome (NMS). Get medical help||
7274|114|S|right away if you have any of the following symptoms: fever,||
7274|115|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
7274|116|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
7274|117|S|signs of kidney problems (such as change in the amount of urine).||
7274|118|S|   A very serious allergic reaction to this drug is rare.||
7274|119|S|However, get medical help right away if you notice any symptoms||
7274|120|S|of a serious allergic reaction, including: fever, swollen lymph||
7274|121|S|nodes, rash, itching/swelling (especially of the||
7274|122|S|face/tongue/throat), severe dizziness, trouble breathing.||
7274|123|S|   This is not a complete list of possible side effects. If you||
7274|124|S|notice other effects not listed above, contact your doctor or||
7274|125|S|pharmacist.||
7274|126|S|   In the US -||
7274|127|S|   Call your doctor for medical advice about side effects. You||
7274|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7274|129|S|www.fda.gov/medwatch.||
7274|130|S|   In Canada - Call your doctor for medical advice about side||
7274|131|S|effects. You may report side effects to Health Canada at||
7274|132|S|1-866-234-2345.||
7274|133|B|||
7274|134|P|PRECAUTIONS:  Before taking olanzapine, tell your doctor or||
7274|135|P|pharmacist if you are allergic to it; or if you have any other||
7274|136|P|allergies. This product may contain inactive ingredients, which||
7274|137|P|can cause allergic reactions or other problems. Talk to your||
7274|138|P|pharmacist for more details.||
7274|139|P|   Before using this medication, tell your doctor or pharmacist||
7274|140|P|your medical history, especially of: liver problems, seizures,||
7274|141|P|difficulty swallowing, low white blood cell count, dementia,||
7274|142|P|difficulty urinating (for example, due to enlarged prostate),||
7274|143|P|glaucoma (narrow angle), stomach/intestinal problems (such as||
7274|144|P|blockage, chronic constipation, paralytic ileus), smoking,||
7274|145|P|personal or family history of diabetes, heart disease, high||
7274|146|P|cholesterol/triglyceride levels, breathing trouble during sleep||
7274|147|P|(sleep apnea).||
7274|148|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7274|149|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7274|150|P|machinery, or do anything that needs alertness until you can do||
7274|151|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
7274|152|P|are using marijuana (cannabis).||
7274|153|P|   Before having surgery, tell your doctor or dentist about all||
7274|154|P|the products you use (including prescription drugs,||
7274|155|P|nonprescription drugs, and herbal products).||
7274|156|P|   This medication may contain aspartame. If you have||
7274|157|P|phenylketonuria (PKU) or any other condition that requires you to||
7274|158|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
7274|159|P|doctor or pharmacist about using this medication safely.||
7274|160|P|   This medication may make you sweat less, making you more||
7274|161|P|likely to get heat stroke. Avoid doing things that may cause you||
7274|162|P|to overheat, such as hard work or exercise in hot weather, or||
7274|163|P|using hot tubs. When the weather is hot, drink a lot of fluids||
7274|164|P|and dress lightly. If you overheat, quickly look for a place to||
7274|165|P|cool down and rest. Get medical help right away if you have a||
7274|166|P|fever that does not go away, mental/mood changes, headache, or||
7274|167|P|dizziness.||
7274|168|P|   Teenagers may be more sensitive to the side effects of this||
7274|169|P|drug, especially weight gain, and also increased amounts of||
7274|170|P|cholesterol, triglycerides, and prolactin. See also Side Effects||
7274|171|P|section for more details.||
7274|172|P|   Older adults may be more sensitive to the side effects of this||
7274|173|P|drug, especially drowsiness, constipation, trouble urinating,||
7274|174|P|confusion, dizziness, and lightheadedness. Drowsiness, confusion,||
7274|175|P|dizziness, and lightheadedness can increase the risk of falling.||
7274|176|P|   During pregnancy, this medication should be used only when||
7274|177|P|clearly needed. Babies born to mothers who have used this drug||
7274|178|P|during the last 3 months of pregnancy may rarely develop symptoms||
7274|179|P|including muscle stiffness or shakiness, drowsiness,||
7274|180|P|feeding/breathing difficulties, or constant crying. If you notice||
7274|181|P|any of these symptoms in your newborn especially during their||
7274|182|P|first month, tell the doctor right away.||
7274|183|P|   Since untreated mental/mood problems (such as schizophrenia,||
7274|184|P|bipolar disorder, depression) can be a serious condition, do not||
7274|185|P|stop taking this medication unless directed by your doctor. If||
7274|186|P|you are planning pregnancy, become pregnant, or think you may be||
7274|187|P|pregnant, immediately discuss with your doctor the benefits and||
7274|188|P|risks of using this medication during pregnancy.||
7274|189|P|   This drug passes into breast milk and may have undesirable||
7274|190|P|effects on a nursing infant. Tell the doctor right away if your||
7274|191|P|baby develops symptoms such as muscle stiffness or shakiness,||
7274|192|P|unusual sleepiness, or difficulty feeding. Consult your doctor||
7274|193|P|before breastfeeding.||
7274|194|B|||
7274|195|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7274|196|I|medications work or increase your risk for serious side effects.||
7274|197|I|This document does not contain all possible drug interactions.||
7274|198|I|Keep a list of all the products you use (including||
7274|199|I|prescription/nonprescription drugs and herbal products) and share||
7274|200|I|it with your doctor and pharmacist. Do not start, stop, or change||
7274|201|I|the dosage of any medicines without your doctor's approval.||
7274|202|I|   A product that may interact with this drug is: metoclopramide.||
7274|203|I|   Tell your doctor or pharmacist if you are taking other||
7274|204|I|products that cause drowsiness such as opioid pain or cough||
7274|205|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7274|206|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
7274|207|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7274|208|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7274|209|I|diphenhydramine).||
7274|210|I|   Check the labels on all your medicines (such as allergy or||
7274|211|I|cough-and-cold products) because they may contain ingredients||
7274|212|I|that cause drowsiness. Ask your pharmacist about using those||
7274|213|I|products safely.||
7274|214|B|||
7274|215|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7274|216|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7274|217|O|poison control center right away. US residents can call||
7274|218|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7274|219|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
7274|220|O|fast/irregular heartbeat, unusual/uncontrolled movements,||
7274|221|O|seizures.||
7274|222|B|||
7274|223|N|NOTES:  Do not share this medication with others.||
7274|224|N|   Lab and/or medical tests (such as blood sugar, weight, blood||
7274|225|N|pressure, blood cholesterol/triglyceride levels, liver function)||
7274|226|N|should be done while you are taking this medication. Keep all||
7274|227|N|medical and lab appointments. Consult your doctor for more||
7274|228|N|details.||
7274|229|B|||
7274|230|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7274|231|D|remember. If it is near the time of the next dose, skip the||
7274|232|D|missed dose. Take your next dose at the regular time. Do not||
7274|233|D|double the dose to catch up.||
7274|234|B|||
7274|235|R|STORAGE:  Store at room temperature away from light and moisture.||
7274|236|R|Do not store in the bathroom. Keep all medications away from||
7274|237|R|children and pets.||
7274|238|R|   Do not flush medications down the toilet or pour them into a||
7274|239|R|drain unless instructed to do so. Properly discard this product||
7274|240|R|when it is expired or no longer needed. Consult your pharmacist||
7274|241|R|or local waste disposal company.||
7274|242|B|||
7274|243|A|Information last revised May 2024.||
7274|244|A|Copyright(c) 2025 First Databank, Inc.||
7274|245|B|||
7280|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7280|002|Z|does NOT have all possible information about this product. This||
7280|003|Z|information does not assure that this product is safe, effective,||
7280|004|Z|or appropriate for you. This information is not individual||
7280|005|Z|medical advice and does not substitute for the advice of your||
7280|006|Z|health care professional. Always ask your health care||
7280|007|Z|professional for complete information about this product and your||
7280|008|Z|specific health needs.||
7280|009|B|||
7280|010|T|MULTIVITAMINS/IRON (INCLUDES PRENATAL VITS) CHEWABLE - ORAL||
7280|011|B|||
7280|012|W|WARNING:  Accidental overdose of iron-containing products is a||
7280|013|W|leading cause of fatal poisoning in children younger than 6||
7280|014|W|years. Keep this product out of reach of children. If overdose||
7280|015|W|does occur, get medical help right away or call a poison control||
7280|016|W|center.||
7280|017|B|||
7280|018|U|USES:  This medication is a multivitamin and iron product used to||
7280|019|U|treat or prevent vitamin deficiency due to poor diet, certain||
7280|020|U|illnesses, or during pregnancy. Vitamins and iron are important||
7280|021|U|building blocks of the body and help keep you in good health.||
7280|022|B|||
7280|023|H|HOW TO USE:  Chew this medication thoroughly and swallow, usually||
7280|024|H|once daily or as directed. Follow all directions on the product||
7280|025|H|package, or take as directed by your doctor. Do not take more||
7280|026|H|than the recommended dosage. If you have any questions, ask your||
7280|027|H|doctor or pharmacist.||
7280|028|H|   This medication is best taken on an empty stomach 1 hour||
7280|029|H|before or 2 hours after meals. If stomach upset occurs, you may||
7280|030|H|take this medication with food. Avoid taking antacids, dairy||
7280|031|H|products, tea, or coffee within 2 hours before or after this||
7280|032|H|medication because they will decrease its effectiveness.||
7280|033|H|   Take this medication regularly in order to get the most||
7280|034|H|benefit from it. To help you remember, take it at the same time||
7280|035|H|each day.||
7280|036|B|||
7280|037|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
7280|038|S|occur. These effects are usually temporary and may disappear as||
7280|039|S|your body adjusts to this medication. If any of these effects||
7280|040|S|last or get worse, tell your doctor or pharmacist promptly.||
7280|041|S|   Iron may cause your stools to turn black, an effect that is||
7280|042|S|not harmful.||
7280|043|S|   If your doctor has prescribed this medication, remember that||
7280|044|S|your doctor has judged that the benefit to you is greater than||
7280|045|S|the risk of side effects. Many people using this medication do||
7280|046|S|not have serious side effects.||
7280|047|S|   A very serious allergic reaction to this drug is rare.||
7280|048|S|However, get medical help right away if you notice any symptoms||
7280|049|S|of a serious allergic reaction, including: rash, itching/swelling||
7280|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7280|051|S|breathing.||
7280|052|S|   This is not a complete list of possible side effects. If you||
7280|053|S|notice other effects not listed above, contact your doctor or||
7280|054|S|pharmacist.||
7280|055|S|   In the US -||
7280|056|S|   Call your doctor for medical advice about side effects. You||
7280|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7280|058|S|www.fda.gov/medwatch.||
7280|059|S|   In Canada - Call your doctor for medical advice about side||
7280|060|S|effects. You may report side effects to Health Canada at||
7280|061|S|1-866-234-2345.||
7280|062|B|||
7280|063|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
7280|064|P|pharmacist if you are allergic to any of its ingredients; or if||
7280|065|P|you have any other allergies. This product may contain inactive||
7280|066|P|ingredients, which can cause allergic reactions or other||
7280|067|P|problems. Talk to your pharmacist for more details.||
7280|068|P|   Before taking this medication, tell your doctor or pharmacist||
7280|069|P|your medical history, especially of: iron overload disorder (such||
7280|070|P|as hemochromatosis, hemosiderosis), use/abuse of alcohol, liver||
7280|071|P|problems, stomach/intestinal problems (such as ulcer, colitis).||
7280|072|P|   If your brand of multivitamin also contains folic acid, be||
7280|073|P|sure to tell your doctor or pharmacist if you have vitamin B12||
7280|074|P|deficiency (pernicious anemia) before taking it. Folic acid may||
7280|075|P|affect certain lab tests for vitamin B12 deficiency without||
7280|076|P|treating this anemia. Untreated vitamin B12 deficiency may result||
7280|077|P|in serious nerve problems (such as peripheral neuropathy).||
7280|078|P|Consult your doctor or pharmacist for details.||
7280|079|P|   This medicine may contain aspartame. If you have||
7280|080|P|phenylketonuria (PKU) or any other condition that requires you to||
7280|081|P|restrict your intake of aspartame (or phenylalanine), consult||
7280|082|P|your doctor or pharmacist about using this drug safely.||
7280|083|P|   Before having surgery, tell your doctor or dentist about all||
7280|084|P|the products you use (including prescription drugs,||
7280|085|P|nonprescription drugs, and herbal products).||
7280|086|P|   Tell your doctor if you are pregnant before using this||
7280|087|P|medication.||
7280|088|P|   This medication passes into breast milk. Consult your doctor||
7280|089|P|before breastfeeding.||
7280|090|B|||
7280|091|I|DRUG INTERACTIONS:  See also How To Use section.||
7280|092|I|   Drug interactions may change how your medications work or||
7280|093|I|increase your risk for serious side effects. This document does||
7280|094|I|not contain all possible drug interactions. Keep a list of all||
7280|095|I|the products you use (including prescription/nonprescription||
7280|096|I|drugs and herbal products) and share it with your doctor and||
7280|097|I|pharmacist. Do not start, stop, or change the dosage of any||
7280|098|I|medicines without your doctor's approval.||
7280|099|I|   This product can decrease the absorption of certain drugs,||
7280|100|I|especially if you take them around the same time. These drugs||
7280|101|I|include bisphosphonates (such as alendronate), levodopa,||
7280|102|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
7280|103|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
7280|104|I|minocycline), thyroid medications (such as levothyroxine), among||
7280|105|I|others. Ask your doctor or pharmacist how long you should wait||
7280|106|I|between doses of this product and your other medications and to||
7280|107|I|find a dosing schedule that works for all your medications.||
7280|108|B|||
7280|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7280|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7280|111|O|poison control center right away. US residents can call||
7280|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7280|113|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
7280|114|O|diarrhea.||
7280|115|B|||
7280|116|N|NOTES:  Keep all medical and lab appointments.||
7280|117|N|   This product is not a substitute for a proper diet. Remember||
7280|118|N|that it is best to get your vitamins and minerals from healthy||
7280|119|N|foods. Maintain a well-balanced diet and follow any dietary||
7280|120|N|guidelines as directed by your doctor.||
7280|121|B|||
7280|122|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7280|123|D|remember. If it is near the time of the next dose, skip the||
7280|124|D|missed dose. Take your next dose at the regular time. Do not||
7280|125|D|double the dose to catch up.||
7280|126|B|||
7280|127|R|STORAGE:  Store at room temperature away from light and moisture.||
7280|128|R|Do not store in the bathroom. Keep all medications away from||
7280|129|R|children and pets.||
7280|130|R|   Do not flush medications down the toilet or pour them into a||
7280|131|R|drain unless instructed to do so. Properly discard this product||
7280|132|R|when it is expired or no longer needed. Consult your pharmacist||
7280|133|R|or local waste disposal company.||
7280|134|B|||
7280|135|A|Information last revised October 2025.||
7280|136|A|Copyright(c) 2025 First Databank, Inc.||
7280|137|B|||
7282|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7282|002|Z|does NOT have all possible information about this product. This||
7282|003|Z|information does not assure that this product is safe, effective,||
7282|004|Z|or appropriate for you. This information is not individual||
7282|005|Z|medical advice and does not substitute for the advice of your||
7282|006|Z|health care professional. Always ask your health care||
7282|007|Z|professional for complete information about this product and your||
7282|008|Z|specific health needs.||
7282|009|B|||
7282|010|T|LORATADINE DISPERSIBLE TABLET - ORAL||
7282|011|F|(lor-AT-uh-deen)||
7282|012|B|||
7282|013|C|COMMON BRAND NAME(S): Alavert ODT, Claritin RediTabs||
7282|014|B|||
7282|015|U|USES:  This medication is an antihistamine that treats symptoms||
7282|016|U|such as itching, runny nose, watery eyes, and sneezing from "hay||
7282|017|U|fever" and other allergies. It is also used to relieve itching||
7282|018|U|from hives.||
7282|019|U|   Loratadine does not prevent hives or prevent/treat a serious||
7282|020|U|allergic reaction (anaphylaxis). If your doctor has prescribed||
7282|021|U|epinephrine to treat allergic reactions, always carry your||
7282|022|U|epinephrine injector with you. Do not use loratadine in place of||
7282|023|U|your epinephrine.||
7282|024|U|   If you are self-treating with this medication, it is important||
7282|025|U|to read the manufacturer's package instructions carefully so you||
7282|026|U|know when to consult your doctor or pharmacist. (See also||
7282|027|U|Precautions section.)||
7282|028|U|   Do not use this medication in children younger than 6 years||
7282|029|U|unless directed by the doctor.||
7282|030|B|||
7282|031|H|HOW TO USE:  If you are using the over-the-counter product to||
7282|032|H|self-treat, read all the directions on the product package before||
7282|033|H|taking this medication. If your doctor has prescribed this||
7282|034|H|medication, follow your doctor's directions and the instructions||
7282|035|H|on your prescription label. If you have any questions, consult||
7282|036|H|your doctor or pharmacist.||
7282|037|H|   Take this medication by mouth with or without food as directed||
7282|038|H|by your doctor or the product package, usually once or twice a||
7282|039|H|day. Remove the tablet from its foil pack immediately before||
7282|040|H|taking and place the tablet on the tongue. It will dissolve||
7282|041|H|quickly. You may swallow the dissolved medication with or without||
7282|042|H|water. The dosage is based on your age, condition, and response||
7282|043|H|to treatment. Do not increase your dose or take this drug more||
7282|044|H|often than directed. Do not take more of this medication than||
7282|045|H|recommended for your age.||
7282|046|H|   Tell your doctor if your allergy symptoms do not get better||
7282|047|H|after 3 days of treatment or if your hives last more than 6||
7282|048|H|weeks. Get medical help right away if your condition gets worse||
7282|049|H|or you think you have a serious medical problem (such as a very||
7282|050|H|serious allergic reaction/anaphylaxis).||
7282|051|B|||
7282|052|S|SIDE EFFECTS:  This drug usually has no side effects. If you have||
7282|053|S|any unusual effects, contact your doctor or pharmacist promptly.||
7282|054|S|   A very serious allergic reaction to this drug is rare.||
7282|055|S|However, get medical help right away if you notice any symptoms||
7282|056|S|of a serious allergic reaction, including: rash, itching/swelling||
7282|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7282|058|S|breathing.||
7282|059|S|   This is not a complete list of possible side effects. If you||
7282|060|S|notice other effects not listed above, contact your doctor or||
7282|061|S|pharmacist.||
7282|062|S|   In the US -||
7282|063|S|   Call your doctor for medical advice about side effects. You||
7282|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7282|065|S|www.fda.gov/medwatch.||
7282|066|S|   In Canada - Call your doctor for medical advice about side||
7282|067|S|effects. You may report side effects to Health Canada at||
7282|068|S|1-866-234-2345.||
7282|069|B|||
7282|070|P|PRECAUTIONS:  Before taking loratadine, tell your doctor or||
7282|071|P|pharmacist if you are allergic to it; or to desloratadine; or if||
7282|072|P|you have any other allergies. This product may contain inactive||
7282|073|P|ingredients, which can cause allergic reactions or other||
7282|074|P|problems. Talk to your pharmacist for more details.||
7282|075|P|   Before using this medication, tell your doctor or pharmacist||
7282|076|P|your medical history. Do not self-treat with this medication||
7282|077|P|without consulting your doctor first if you have certain medical||
7282|078|P|conditions such as: kidney disease, liver disease.||
7282|079|P|   Loratadine does not usually cause drowsiness when used at||
7282|080|P|recommended doses. However, do not drive, use machinery, or do||
7282|081|P|anything that needs alertness until you can do it safely.||
7282|082|P|   If you have hives and your doctor has prescribed loratadine,||
7282|083|P|or if you are considering using this drug to treat your own||
7282|084|P|hives, tell your doctor right away if you have any of these other||
7282|085|P|symptoms because they may be signs of a more serious condition:||
7282|086|P|hives that are an unusual color, hives that look bruised or||
7282|087|P|blistered, hives that do not itch.||
7282|088|P|   This product may contain aspartame. If you have||
7282|089|P|phenylketonuria (PKU) or any other condition that requires you to||
7282|090|P|restrict your intake of aspartame (or phenylalanine), consult||
7282|091|P|your doctor or pharmacist about using this drug safely.||
7282|092|P|   Before having surgery, tell your doctor or dentist about all||
7282|093|P|the products you use (including prescription drugs,||
7282|094|P|nonprescription drugs, and herbal products).||
7282|095|P|   Older adults may be more sensitive to the side effects of this||
7282|096|P|drug, especially drowsiness, or confusion. These side effects can||
7282|097|P|increase the risk of falling.||
7282|098|P|   During pregnancy, this medication should be used only when||
7282|099|P|clearly needed. Discuss the risks and benefits with your doctor||
7282|100|P|before taking this drug.||
7282|101|P|   This medication passes into breast milk. However, it is||
7282|102|P|unlikely to harm a nursing infant. Consult your doctor before||
7282|103|P|breastfeeding.||
7282|104|B|||
7282|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7282|106|I|medications work or increase your risk for serious side effects.||
7282|107|I|This document does not contain all possible drug interactions.||
7282|108|I|Keep a list of all the products you use (including||
7282|109|I|prescription/nonprescription drugs and herbal products) and share||
7282|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
7282|111|I|the dosage of any medicines without your doctor's approval.||
7282|112|I|   Loratadine is very similar to desloratadine. Do not use||
7282|113|I|medications containing desloratadine while using loratadine.||
7282|114|I|   This medication may interfere with certain lab tests (such as||
7282|115|I|allergy skin testing), possibly causing false test results. Make||
7282|116|I|sure lab personnel and all your doctors know you use this drug.||
7282|117|B|||
7282|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7282|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7282|120|O|poison control center right away. US residents can call||
7282|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7282|122|O|Symptoms of overdose may include: severe drowsiness.||
7282|123|B|||
7282|124|N|NOTES:  If your doctor has prescribed this medication for you, do||
7282|125|N|not share it with others.||
7282|126|B|||
7282|127|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7282|128|D|remember. If it is near the time of the next dose, skip the||
7282|129|D|missed dose. Take your next dose at the regular time. Do not||
7282|130|D|double the dose to catch up.||
7282|131|B|||
7282|132|R|STORAGE:  Different brands/strengths of this medication may have||
7282|133|R|different storage requirements. Read the package labeling or ask||
7282|134|R|your pharmacist for the storage requirements for the product you||
7282|135|R|are using. Protect from light. Do not store in the bathroom. Keep||
7282|136|R|all medications away from children and pets.||
7282|137|R|   Do not flush medications down the toilet or pour them into a||
7282|138|R|drain unless instructed to do so. Properly discard this product||
7282|139|R|when it is expired or no longer needed. Consult your pharmacist||
7282|140|R|or local waste disposal company.||
7282|141|B|||
7282|142|A|Information last revised November 2025.||
7282|143|A|Copyright(c) 2025 First Databank, Inc.||
7282|144|B|||
7288|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7288|002|Z|does NOT have all possible information about this product. This||
7288|003|Z|information does not assure that this product is safe, effective,||
7288|004|Z|or appropriate for you. This information is not individual||
7288|005|Z|medical advice and does not substitute for the advice of your||
7288|006|Z|health care professional. Always ask your health care||
7288|007|Z|professional for complete information about this product and your||
7288|008|Z|specific health needs.||
7288|009|B|||
7288|010|T|PRENATAL VITAMINS/IRON/FOLIC ACID CHEWABLE TABLET - ORAL||
7288|011|B|||
7288|012|W|WARNING:  Accidental overdose of iron-containing products is a||
7288|013|W|leading cause of fatal poisoning in children under 6 years of||
7288|014|W|age. Keep this product out of reach of children. If overdose does||
7288|015|W|occur, get medical help right away or call a poison control||
7288|016|W|center.||
7288|017|B|||
7288|018|U|USES:  This medication is a multivitamin and mineral product used||
7288|019|U|to treat or prevent vitamin deficiency due to poor diet, certain||
7288|020|U|illnesses, or during pregnancy. Vitamins are important building||
7288|021|U|blocks of the body and help keep you in good health. Women of||
7288|022|U|childbearing age should maintain adequate levels of folic acid||
7288|023|U|either through diet or supplements to prevent infant spinal cord||
7288|024|U|defects.||
7288|025|B|||
7288|026|H|HOW TO USE:  Chew and swallow this medication by mouth, usually||
7288|027|H|once daily on an empty stomach (1 hour before or 2 hours after a||
7288|028|H|meal) or as directed by your doctor. If stomach upset occurs, you||
7288|029|H|may take this medication with food. Avoid taking antacids, dairy||
7288|030|H|products, tea, or coffee within 2 hours before or after this||
7288|031|H|medication because they will decrease its effectiveness.||
7288|032|H|   Use this medication regularly in order to get the most benefit||
7288|033|H|from it. To help you remember, take it at the same time each day.||
7288|034|B|||
7288|035|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
7288|036|S|occur. These effects are usually temporary and may disappear as||
7288|037|S|your body adjusts to this medication. If any of these effects||
7288|038|S|last or get worse, tell your doctor or pharmacist promptly.||
7288|039|S|   Iron may cause your stools to turn black, which is not||
7288|040|S|harmful.||
7288|041|S|   If your doctor has directed you to use this medication,||
7288|042|S|remember that your doctor has judged that the benefit to you is||
7288|043|S|greater than the risk of side effects. Many people using this||
7288|044|S|medication do not have serious side effects.||
7288|045|S|   A very serious allergic reaction to this drug is rare.||
7288|046|S|However, get medical help right away if you notice any symptoms||
7288|047|S|of a serious allergic reaction, including: rash, itching/swelling||
7288|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7288|049|S|breathing.||
7288|050|S|   This is not a complete list of possible side effects. If you||
7288|051|S|notice other effects not listed above, contact your doctor or||
7288|052|S|pharmacist.||
7288|053|S|   In the US -||
7288|054|S|   Call your doctor for medical advice about side effects. You||
7288|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7288|056|S|www.fda.gov/medwatch.||
7288|057|S|   In Canada - Call your doctor for medical advice about side||
7288|058|S|effects. You may report side effects to Health Canada at||
7288|059|S|1-866-234-2345.||
7288|060|B|||
7288|061|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
7288|062|P|pharmacist if you are allergic to it; or if you have any other||
7288|063|P|allergies. This product may contain inactive ingredients, which||
7288|064|P|can cause allergic reactions or other problems. Talk to your||
7288|065|P|pharmacist for more details.||
7288|066|P|   Before taking this medication, tell your doctor or pharmacist||
7288|067|P|your medical history, especially of: iron overload disorder (such||
7288|068|P|as hemochromatosis, hemosiderosis), use/abuse of alcohol, liver||
7288|069|P|problems, stomach/intestinal problems (such as ulcer, colitis),||
7288|070|P|vitamin B12 deficiency (pernicious anemia).||
7288|071|P|   Before having surgery, tell your doctor or dentist about all||
7288|072|P|the products you use (including prescription drugs,||
7288|073|P|nonprescription drugs, and herbal products).||
7288|074|P|   This medication passes into breast milk. Consult your doctor||
7288|075|P|before breastfeeding.||
7288|076|B|||
7288|077|I|DRUG INTERACTIONS:  See also How To Use section.||
7288|078|I|   Drug interactions may change how your medications work or||
7288|079|I|increase your risk for serious side effects. This document does||
7288|080|I|not contain all possible drug interactions. Keep a list of all||
7288|081|I|the products you use (including prescription/nonprescription||
7288|082|I|drugs and herbal products) and share it with your doctor and||
7288|083|I|pharmacist. Do not start, stop, or change the dosage of any||
7288|084|I|medicines without your doctor's approval.||
7288|085|I|   This product can decrease the absorption of certain drugs,||
7288|086|I|especially if you take them around the same time. These drugs||
7288|087|I|include bisphosphonates (such as alendronate), levodopa,||
7288|088|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
7288|089|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
7288|090|I|minocycline), thyroid medications (such as levothyroxine), among||
7288|091|I|others. Ask your doctor or pharmacist how long you should wait||
7288|092|I|between doses of this product and your other medications and to||
7288|093|I|find a dosing schedule that works for all your medications.||
7288|094|I|   This product may interfere with certain lab tests (such as||
7288|095|I|fecal occult blood tests), possibly causing false test results.||
7288|096|I|Make sure lab personnel and all your doctors know you use this||
7288|097|I|product.||
7288|098|B|||
7288|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7288|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7288|101|O|poison control center right away. US residents can call||
7288|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7288|103|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
7288|104|O|diarrhea.||
7288|105|B|||
7288|106|N|NOTES:  Do not share this medication with others.||
7288|107|N|   Lab and/or medical tests (such as complete blood count,||
7288|108|N|vitamin B12 levels) may be done while you are taking this||
7288|109|N|product. Keep all medical and lab appointments. Consult your||
7288|110|N|doctor for more details.||
7288|111|N|   This medication is not a substitute for a proper diet. It is||
7288|112|N|important to maintain a well-balanced diet. Foods rich in iron||
7288|113|N|include red meats (especially liver), fish, beans, and dried||
7288|114|N|fruit. Folic acid and iron are also added to fortified/enriched||
7288|115|N|cereals and bread.||
7288|116|B|||
7288|117|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7288|118|D|remember. If it is near the time of the next dose, skip the||
7288|119|D|missed dose. Take your next dose at the regular time. Do not||
7288|120|D|double the dose to catch up.||
7288|121|B|||
7288|122|R|STORAGE:  Store at room temperature away from light and moisture.||
7288|123|R|Do not store in the bathroom. Keep all medications away from||
7288|124|R|children and pets.||
7288|125|R|   Do not flush medications down the toilet or pour them into a||
7288|126|R|drain unless instructed to do so. Properly discard this product||
7288|127|R|when it is expired or no longer needed. Consult your pharmacist||
7288|128|R|or local waste disposal company.||
7288|129|B|||
7288|130|A|Information last revised October 2025.||
7288|131|A|Copyright(c) 2025 First Databank, Inc.||
7288|132|B|||
7294|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7294|002|Z|does NOT have all possible information about this product. This||
7294|003|Z|information does not assure that this product is safe, effective,||
7294|004|Z|or appropriate for you. This information is not individual||
7294|005|Z|medical advice and does not substitute for the advice of your||
7294|006|Z|health care professional. Always ask your health care||
7294|007|Z|professional for complete information about this product and your||
7294|008|Z|specific health needs.||
7294|009|B|||
7294|010|T|ABACAVIR - ORAL||
7294|011|F|(a-BAK-a-vir)||
7294|012|B|||
7294|013|C|COMMON BRAND NAME(S): Ziagen||
7294|014|B|||
7294|015|W|WARNING:  In some patients, abacavir has caused a serious||
7294|016|W|(sometimes fatal) allergic reaction. Your doctor should order a||
7294|017|W|blood test to measure your risk before you start this medication||
7294|018|W|or take it again. If the blood test shows you are at greater||
7294|019|W|risk, you should not take this medication and your doctor should||
7294|020|W|discuss other treatment choices with you. Symptoms of an allergic||
7294|021|W|reaction may include any of the following: rash, itching/swelling||
7294|022|W|(especially of the face/tongue/throat), severe dizziness, trouble||
7294|023|W|breathing, fever, extreme tiredness, nausea, vomiting, diarrhea,||
7294|024|W|stomach pain, muscle aches, sore throat, or cough. Get medical||
7294|025|W|help right away if you experience any of these symptoms. If you||
7294|026|W|have stopped taking abacavir because of an allergic reaction, you||
7294|027|W|must never take any form of abacavir again, or death could||
7294|028|W|result. Tell all of your doctors and pharmacists if you have||
7294|029|W|stopped taking abacavir due to an allergic reaction. Also,||
7294|030|W|properly throw away any unused abacavir. Read the warning card||
7294|031|W|provided with this medication for more details.||
7294|032|B|||
7294|033|U|USES:  This drug is used with other HIV medications to help||
7294|034|U|control HIV infection. It helps to decrease the amount of HIV in||
7294|035|U|your body so your immune system can work better. This lowers your||
7294|036|U|chance of getting HIV complications (such as new infections,||
7294|037|U|cancer) and improves your quality of life. Abacavir belongs to a||
7294|038|U|class of drugs known as nucleoside reverse transcriptase||
7294|039|U|inhibitors-NRTI.||
7294|040|U|   Abacavir is not a cure for HIV infection. To decrease your||
7294|041|U|risk of spreading HIV disease to others, continue to take all HIV||
7294|042|U|medications exactly as prescribed by your doctor. Use an||
7294|043|U|effective barrier method (latex or polyurethane condoms/dental||
7294|044|U|dams) during sexual activity as directed by your doctor. Do not||
7294|045|U|share personal items (such as needles/syringes, toothbrushes, and||
7294|046|U|razors) that may have contacted blood or other body fluids.||
7294|047|U|Consult your doctor or pharmacist for more details.||
7294|048|B|||
7294|049|H|HOW TO USE:  Read the Medication Guide and Warning Card provided||
7294|050|H|by your pharmacist before you start taking abacavir and each time||
7294|051|H|you get a refill. Carry the Warning Card with you at all times.||
7294|052|H|If you have any questions, ask your doctor or pharmacist.||
7294|053|H|   Take this medication by mouth with or without food as directed||
7294|054|H|by your doctor, usually 1 or 2 times daily. If you are using the||
7294|055|H|liquid form of this medication, carefully measure the dose using||
7294|056|H|a special measuring device/spoon. Do not use a household spoon||
7294|057|H|because you may not get the correct dose.||
7294|058|H|   The dosage is based on your medical condition and response to||
7294|059|H|treatment. Children's dosage is also based on weight.||
7294|060|H|   If you stop using abacavir even for a short time and then||
7294|061|H|restart the drug, you have an increased chance of developing a||
7294|062|H|very serious (possibly fatal) allergic reaction. Refill your||
7294|063|H|medication before you run out. Do not stop treatment unless||
7294|064|H|directed by your doctor. Before restarting abacavir, consult your||
7294|065|H|doctor or pharmacist, and be sure you have easy access to medical||
7294|066|H|care.||
7294|067|H|   It is very important to keep taking this medication (and other||
7294|068|H|HIV medications) exactly as prescribed by your doctor. Do not||
7294|069|H|skip any doses. Do not increase your dose, take this drug more||
7294|070|H|often than prescribed, or stop taking it (or other HIV medicines)||
7294|071|H|even for a short time unless directed to do so by your doctor.||
7294|072|H|Skipping or changing your dose without approval from your doctor||
7294|073|H|may cause the amount of virus to increase, make the infection||
7294|074|H|more difficult to treat (resistant), or worsen side effects.||
7294|075|H|   For the best effect, take this medication at evenly spaced||
7294|076|H|times. To help you remember, take this medication at the same||
7294|077|H|time(s) every day.||
7294|078|B|||
7294|079|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
7294|080|S|   Trouble sleeping or loss of appetite may occur. If any of||
7294|081|S|these effects last or get worse, tell your doctor or pharmacist||
7294|082|S|promptly.||
7294|083|S|   Remember that this medication has been prescribed because your||
7294|084|S|doctor has judged that the benefit to you is greater than the||
7294|085|S|risk of side effects. Many people using this medication do not||
7294|086|S|have serious side effects.||
7294|087|S|   As your immune system gets stronger, it can begin to fight off||
7294|088|S|infections you already had, possibly causing disease symptoms to||
7294|089|S|come back. You could also have symptoms if your immune system||
7294|090|S|becomes overactive. This reaction may happen at any time (soon||
7294|091|S|after starting HIV treatment or many months later). Tell your||
7294|092|S|doctor right away if you have any serious symptoms, including:||
7294|093|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
7294|094|S|that doesn't go away, headaches that are severe or don't go away,||
7294|095|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
7294|096|S|changes, signs of infection (such as sore throat that doesn't go||
7294|097|S|away, fever, chills, swollen lymph nodes, non-healing skin||
7294|098|S|sores), signs of an overactive thyroid (such as irritability,||
7294|099|S|nervousness, heat intolerance, fast/pounding/irregular||
7294|100|S|heartbeat).||
7294|101|S|   Tell your doctor right away if you have any serious side||
7294|102|S|effects, including: mental/mood changes (depression, anxiety).||
7294|103|S|   Rarely, this medication has caused severe (sometimes fatal)||
7294|104|S|liver problems and a buildup of lactic acid in the blood (lactic||
7294|105|S|acidosis). These serious side effects may occur more often in||
7294|106|S|women and obese patients. Get medical help right away if you have||
7294|107|S|any of the following serious symptoms, including: symptoms of||
7294|108|S|liver problems (such as nausea/vomiting that doesn't stop,||
7294|109|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
7294|110|S|symptoms of lactic acidosis (such as deep/rapid breathing,||
7294|111|S|drowsiness, nausea/vomiting).||
7294|112|S|   This is not a complete list of possible side effects. If you||
7294|113|S|notice other effects not listed above, contact your doctor or||
7294|114|S|pharmacist.||
7294|115|S|   In the US -||
7294|116|S|   Call your doctor for medical advice about side effects. You||
7294|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7294|118|S|www.fda.gov/medwatch.||
7294|119|S|   In Canada - Call your doctor for medical advice about side||
7294|120|S|effects. You may report side effects to Health Canada at||
7294|121|S|1-866-234-2345.||
7294|122|B|||
7294|123|P|PRECAUTIONS:  See also Warning and How to Use sections.||
7294|124|P|   Before taking abacavir, tell your doctor or pharmacist if you||
7294|125|P|are allergic to it; or if you have any other allergies. This||
7294|126|P|product may contain inactive ingredients, which can cause||
7294|127|P|allergic reactions or other problems. Talk to your pharmacist for||
7294|128|P|more details.||
7294|129|P|   Before using this medication, tell your doctor or pharmacist||
7294|130|P|your medical history, especially of: liver problems (such as||
7294|131|P|hepatitis B or C, or cirrhosis), kidney problems, alcohol use.||
7294|132|P|   Abacavir may increase your risk of a heart attack. Discuss the||
7294|133|P|risks and benefits of treatment with your doctor and ways to||
7294|134|P|lower your risk of heart disease. Tell your doctor if you have||
7294|135|P|heart problems, if you smoke, or if you have other conditions||
7294|136|P|that increase your risk of heart disease such as high blood||
7294|137|P|pressure, diabetes, or high cholesterol levels.||
7294|138|P|   Before having surgery, tell your doctors or dentist about all||
7294|139|P|the products you use (including prescription drugs,||
7294|140|P|nonprescription drugs, and herbal products).||
7294|141|P|   Tell your doctor if you are pregnant before using this||
7294|142|P|medication. Treatment can lower the risk of passing HIV infection||
7294|143|P|to your baby. Discuss the risks and benefits with your doctor.||
7294|144|P|   This medication passes into breast milk. Because breast milk||
7294|145|P|may transmit HIV, consult your doctor before breastfeeding.||
7294|146|B|||
7294|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7294|148|I|medications work or increase your risk for serious side effects.||
7294|149|I|This document does not contain all possible drug interactions.||
7294|150|I|Keep a list of all the products you use (including||
7294|151|I|prescription/nonprescription drugs and herbal products) and share||
7294|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
7294|153|I|the dosage of any medicines without your doctor's approval.||
7294|154|I|   Some products that may interact with this drug include:||
7294|155|I|alcohol, methadone, orlistat.||
7294|156|I|   This medication must not be taken with other medications that||
7294|157|I|contain abacavir. Check the labels on all your other prescription||
7294|158|I|medications to make sure they do not contain abacavir. If you||
7294|159|I|have any questions, consult your doctor or pharmacist.||
7294|160|B|||
7294|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7294|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7294|163|O|poison control center right away. US residents can call||
7294|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7294|165|B|||
7294|166|N|NOTES:  Do not share this medication with others.||
7294|167|N|   Lab and/or medical tests (such as liver function, viral load,||
7294|168|N|T-cell counts) should be done while you are taking this||
7294|169|N|medication. Keep all medical and lab appointments. Consult your||
7294|170|N|doctor for more details.||
7294|171|B|||
7294|172|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7294|173|D|remember. If it is near the time of the next dose, skip the||
7294|174|D|missed dose. Take your next dose at the regular time. Do not||
7294|175|D|double the dose to catch up.||
7294|176|B|||
7294|177|R|STORAGE:  Store abacavir solution or tablets at room temperature||
7294|178|R|away from light and moisture. Abacavir solution may also be||
7294|179|R|stored in the refrigerator. Do not freeze. The solution may turn||
7294|180|R|from a clear or yellow color to a brown color over time. Do not||
7294|181|R|store in the bathroom. Keep all medications away from children||
7294|182|R|and pets.||
7294|183|R|   Do not flush medications down the toilet or pour them into a||
7294|184|R|drain unless instructed to do so. Properly discard this product||
7294|185|R|when it is expired or no longer needed. Consult your pharmacist||
7294|186|R|or local waste disposal company.||
7294|187|B|||
7294|188|A|Information last revised April 2025.||
7294|189|A|Copyright(c) 2025 First Databank, Inc.||
7294|190|B|||
7296|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7296|002|Z|does NOT have all possible information about this product. This||
7296|003|Z|information does not assure that this product is safe, effective,||
7296|004|Z|or appropriate for you. This information is not individual||
7296|005|Z|medical advice and does not substitute for the advice of your||
7296|006|Z|health care professional. Always ask your health care||
7296|007|Z|professional for complete information about this product and your||
7296|008|Z|specific health needs.||
7296|009|B|||
7296|010|T|APREPITANT - ORAL||
7296|011|F|(a-PRE-pi-tant)||
7296|012|B|||
7296|013|C|COMMON BRAND NAME(S): Emend||
7296|014|B|||
7296|015|U|USES:  Aprepitant is used with other medications to help prevent||
7296|016|U|nausea and vomiting caused by cancer drug treatment||
7296|017|U|(chemotherapy). Aprepitant works by blocking one of the body's||
7296|018|U|natural substances (substance P/neurokinin 1) that causes||
7296|019|U|vomiting.||
7296|020|U|   This medication will not treat nausea or vomiting that has||
7296|021|U|already started. Ask your doctor what you should do if you||
7296|022|U|already have nausea or vomiting.||
7296|023|B|||
7296|024|V|OTHER USES:  This section contains uses of this drug that are not||
7296|025|V|listed in the approved professional labeling for the drug but||
7296|026|V|that may be prescribed by your health care professional. Use this||
7296|027|V|drug for a condition that is listed in this section only if it||
7296|028|V|has been so prescribed by your health care professional.||
7296|029|V|   This medication may also be used for nausea and vomiting after||
7296|030|V|surgery.||
7296|031|B|||
7296|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7296|033|H|from your pharmacist before you start taking aprepitant and each||
7296|034|H|time you get a refill. If you are taking the liquid form of this||
7296|035|H|medication, read the Instructions for Use sheet for directions on||
7296|036|H|the proper use of this medication. If you have any questions, ask||
7296|037|H|your doctor or pharmacist.||
7296|038|H|   Take this medication by mouth with or without food as directed||
7296|039|H|by your doctor. If you are taking capsules, swallow the capsules||
7296|040|H|whole.||
7296|041|H|   Take the first dose as directed by your doctor, usually 1 hour||
7296|042|H|before the start of chemotherapy. For the next 2 days, continue||
7296|043|H|to take a dose once daily 1 hour before the start of treatment if||
7296|044|H|you are getting chemotherapy that day. If you are not getting any||
7296|045|H|chemotherapy, then take the dose once daily in the morning.||
7296|046|H|   The dosage is based on your medical condition, age, and||
7296|047|H|response to treatment. Children's dosage is also based on weight.||
7296|048|H|It is important to follow your doctor's instructions for when to||
7296|049|H|take each dose, how long to keep taking it, and the strength||
7296|050|H|(number of milligrams) of each dose. If you have any questions,||
7296|051|H|ask your doctor or pharmacist.||
7296|052|H|   Tell your doctor if you vomit or feel nauseated.||
7296|053|B|||
7296|054|S|SIDE EFFECTS:  Tiredness or hiccups may occur. If either of these||
7296|055|S|effects lasts or gets worse, tell your doctor or pharmacist||
7296|056|S|promptly.||
7296|057|S|   Remember that this medication has been prescribed because your||
7296|058|S|doctor has judged that the benefit to you is greater than the||
7296|059|S|risk of side effects. Many people using this medication do not||
7296|060|S|have serious side effects.||
7296|061|S|   A very serious allergic reaction to this drug is rare.||
7296|062|S|However, get medical help right away if you notice any symptoms||
7296|063|S|of a serious allergic reaction, including: rash, itching/swelling||
7296|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7296|065|S|breathing.||
7296|066|S|   This is not a complete list of possible side effects. If you||
7296|067|S|notice other effects not listed above, contact your doctor or||
7296|068|S|pharmacist.||
7296|069|S|   In the US -||
7296|070|S|   Call your doctor for medical advice about side effects. You||
7296|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7296|072|S|www.fda.gov/medwatch.||
7296|073|S|   In Canada - Call your doctor for medical advice about side||
7296|074|S|effects. You may report side effects to Health Canada at||
7296|075|S|1-866-234-2345.||
7296|076|B|||
7296|077|P|PRECAUTIONS:  Before taking aprepitant, tell your doctor or||
7296|078|P|pharmacist if you are allergic to it; or to fosaprepitant; or if||
7296|079|P|you have any other allergies. This product may contain inactive||
7296|080|P|ingredients, which can cause allergic reactions or other||
7296|081|P|problems. Talk to your pharmacist for more details.||
7296|082|P|   Before using this medication, tell your doctor or pharmacist||
7296|083|P|your medical history, especially of: liver disease.||
7296|084|P|   Before having surgery, tell your doctor or dentist about all||
7296|085|P|the products you use (including prescription drugs,||
7296|086|P|nonprescription drugs, and herbal products).||
7296|087|P|   During pregnancy, this medication should be used only when||
7296|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
7296|089|P|   It is unknown if this drug passes into breast milk. Consult||
7296|090|P|your doctor before breastfeeding.||
7296|091|B|||
7296|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7296|093|I|medications work or increase your risk for serious side effects.||
7296|094|I|This document does not contain all possible drug interactions.||
7296|095|I|Keep a list of all the products you use (including||
7296|096|I|prescription/nonprescription drugs and herbal products) and share||
7296|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
7296|098|I|the dosage of any medicines without your doctor's approval.||
7296|099|I|   Other medications can affect the removal of aprepitant from||
7296|100|I|your body, which may affect how aprepitant works. Examples||
7296|101|I|include azole antifungals (such as itraconazole, ketoconazole),||
7296|102|I|diltiazem, macrolide antibiotics (such as clarithromycin,||
7296|103|I|erythromycin), nefazodone, HIV protease inhibitors (such as||
7296|104|I|nelfinavir), rifamycins (such as rifampin, rifabutin), ritonavir,||
7296|105|I|St. John's wort, certain anti-seizure medicines (such as||
7296|106|I|carbamazepine, phenytoin), among others.||
7296|107|I|   Aprepitant can both speed up or slow down the removal of other||
7296|108|I|medications from your body, which may affect how they work.||
7296|109|I|Examples of affected drugs include elacestrant, flibanserin,||
7296|110|I|lomitapide, pimozide, among others.||
7296|111|I|   If you take warfarin, this drug may affect how well warfarin||
7296|112|I|works in your body. Your doctor should test your blood during the||
7296|113|I|2 weeks after your aprepitant treatment to measure how well||
7296|114|I|warfarin is working.||
7296|115|I|   This medication may decrease the effectiveness of hormonal||
7296|116|I|birth control such as pills, patch, or ring. This could cause||
7296|117|I|pregnancy. Discuss with your doctor or pharmacist if you should||
7296|118|I|use reliable backup birth control methods while using this||
7296|119|I|medication and for 1 month after the last dose. Also tell your||
7296|120|I|doctor if you have any new spotting or breakthrough bleeding,||
7296|121|I|because these may be signs that your birth control is not working||
7296|122|I|well.||
7296|123|I|   Aprepitant is very similar to fosaprepitant. Do not use||
7296|124|I|fosaprepitant while using aprepitant.||
7296|125|B|||
7296|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7296|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7296|128|O|poison control center right away. US residents can call||
7296|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7296|130|B|||
7296|131|N|NOTES:  Do not share this medication with others.||
7296|132|B|||
7296|133|D|MISSED DOSE:  It is important to take each dose of this||
7296|134|D|medication as scheduled. If you miss a dose, ask your doctor or||
7296|135|D|pharmacist right away for a new dosing schedule. Do not double||
7296|136|D|the dose to catch up.||
7296|137|B|||
7296|138|R|STORAGE:  Store the capsules at room temperature away from light||
7296|139|R|and moisture. Do not store in the bathroom. Store the liquid in||
7296|140|R|the refrigerator and discard any unused liquid after 72 hours. Do||
7296|141|R|not freeze. When ready to use, the liquid form of this medication||
7296|142|R|may be stored at room temperature for up to 3 hours. Keep all||
7296|143|R|medications away from children and pets.||
7296|144|R|   Do not flush medications down the toilet or pour them into a||
7296|145|R|drain unless instructed to do so. Properly discard this product||
7296|146|R|when it is expired or no longer needed. Consult your pharmacist||
7296|147|R|or local waste disposal company.||
7296|148|B|||
7296|149|A|Information last revised September 2024.||
7296|150|A|Copyright(c) 2025 First Databank, Inc.||
7296|151|B|||
7301|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7301|002|Z|does NOT have all possible information about this product. This||
7301|003|Z|information does not assure that this product is safe, effective,||
7301|004|Z|or appropriate for you. This information is not individual||
7301|005|Z|medical advice and does not substitute for the advice of your||
7301|006|Z|health care professional. Always ask your health care||
7301|007|Z|professional for complete information about this product and your||
7301|008|Z|specific health needs.||
7301|009|B|||
7301|010|T|TACROLIMUS - TOPICAL||
7301|011|F|(ta-KROE-li-mus)||
7301|012|B|||
7301|013|C|COMMON BRAND NAME(S): Protopic||
7301|014|B|||
7301|015|W|WARNING:  The long-term safety of this drug is not known. There||
7301|016|W|have been rare reports of cancer (such as skin cancer, lymphoma)||
7301|017|W|in patients using tacrolimus on the skin. It is unknown if||
7301|018|W|tacrolimus caused these cancers. Because of this possible risk,||
7301|019|W|this drug should be used only if other drugs have not worked or||
7301|020|W|if your doctor decides that other medications should not be used||
7301|021|W|for your condition. Tacrolimus should be used on the skin for||
7301|022|W|short treatment periods only. If needed, treatment may be||
7301|023|W|repeated with breaks in between. Use the smallest amount that||
7301|024|W|will treat your condition properly, and apply only on the||
7301|025|W|affected skin. This medication should not be used by children||
7301|026|W|younger than 2 years. Discuss the risks, benefits, and proper use||
7301|027|W|of this medication with your doctor. Tell your doctor right away||
7301|028|W|if you develop any of the following: unusual skin changes, change||
7301|029|W|in the appearance/size of moles, unusual growths/lumps, or||
7301|030|W|swollen lymph nodes.||
7301|031|B|||
7301|032|U|USES:  This form of tacrolimus is used on the skin to treat a||
7301|033|U|skin condition called eczema (atopic dermatitis) in patients who||
7301|034|U|have not responded well to (or should not use) other eczema||
7301|035|U|medications.||
7301|036|U|   Eczema is an allergic-type condition that causes red,||
7301|037|U|irritated, and itchy skin. This drug works by weakening the||
7301|038|U|skin's defense (immune) system, thereby decreasing the allergic||
7301|039|U|reaction and relieving the eczema. Tacrolimus belongs to a class||
7301|040|U|of drugs known as topical calcineurin inhibitors (TCIs).||
7301|041|U|   For children 2 to 15 years of age, the lower strength product||
7301|042|U|should be used.||
7301|043|B|||
7301|044|V|OTHER USES:  This section contains uses of this drug that are not||
7301|045|V|listed in the approved professional labeling for the drug but||
7301|046|V|that may be prescribed by your health care professional. Use this||
7301|047|V|drug for a condition that is listed in this section only if it||
7301|048|V|has been so prescribed by your health care professional.||
7301|049|V|   This medication may also be used for a certain skin condition||
7301|050|V|that causes patchy loss of skin coloring (vitiligo).||
7301|051|B|||
7301|052|H|HOW TO USE:  Read the Medication Guide provided by your||
7301|053|H|pharmacist before you start using tacrolimus and each time you||
7301|054|H|get a refill. If you have any questions, consult your doctor or||
7301|055|H|pharmacist.||
7301|056|H|   Wash your hands with soap and water before using this||
7301|057|H|medication. Apply a thin layer to the affected areas of skin as||
7301|058|H|directed by your doctor, usually twice daily. Rub the medication||
7301|059|H|into the skin gently and completely. Wash your hands after using||
7301|060|H|this product unless your hands are being treated. If your doctor||
7301|061|H|recommends a moisturizer, apply it after this medication.||
7301|062|H|   This product is for use on the skin only. Avoid getting this||
7301|063|H|medication in your eyes or on the inside of your nose or mouth.||
7301|064|H|If you do get the medication in those areas, flush with plenty of||
7301|065|H|water. Do not apply this medication to open wounds or infected||
7301|066|H|areas. Do not cover the treated area with plastic or waterproof||
7301|067|H|bandages unless directed to do so by your doctor. Do not bathe,||
7301|068|H|shower, or swim right after applying this medication. This could||
7301|069|H|wash it off the treated area.||
7301|070|H|   Use this medication exactly as directed. Your doctor may||
7301|071|H|instruct you to stop using it once your eczema has cleared and to||
7301|072|H|start using it again if symptoms reappear. Consult your doctor||
7301|073|H|for details.||
7301|074|H|   Tell your doctor if your condition does not get better after 6||
7301|075|H|weeks of using this medication or if your condition gets worse at||
7301|076|H|any time.||
7301|077|B|||
7301|078|S|SIDE EFFECTS:  Stinging, burning, soreness, or itching in the||
7301|079|S|area of treated skin may occur during the first few days of||
7301|080|S|treatment. Headache, acne, small red bumps on the skin||
7301|081|S|(folliculitis), stomach upset, flu-like symptoms (such as fever,||
7301|082|S|chills, runny nose, sore throat, muscle aches), or increased||
7301|083|S|sensitivity of the skin to hot/cold/pain/touch may also occur. If||
7301|084|S|any of these effects last or get worse, tell your doctor or||
7301|085|S|pharmacist promptly.||
7301|086|S|   Remember that this medication has been prescribed because your||
7301|087|S|doctor has judged that the benefit to you is greater than the||
7301|088|S|risk of side effects. Many people using this medication do not||
7301|089|S|have serious side effects.||
7301|090|S|   Tell your doctor right away if you have any serious side||
7301|091|S|effects, including: unusual tiredness, back/joint/muscle pain,||
7301|092|S|appearance of any skin infections or sores (such as chicken pox,||
7301|093|S|shingles, lip sores, tumors, warts), chest pain.||
7301|094|S|   A very serious allergic reaction to this drug is rare.||
7301|095|S|However, get medical help right away if you notice any symptoms||
7301|096|S|of a serious allergic reaction, including: rash, itching/swelling||
7301|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7301|098|S|breathing.||
7301|099|S|   This is not a complete list of possible side effects. If you||
7301|100|S|notice other effects not listed above, contact your doctor or||
7301|101|S|pharmacist.||
7301|102|S|   In the US -||
7301|103|S|   Call your doctor for medical advice about side effects. You||
7301|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7301|105|S|www.fda.gov/medwatch.||
7301|106|S|   In Canada - Call your doctor for medical advice about side||
7301|107|S|effects. You may report side effects to Health Canada at||
7301|108|S|1-866-234-2345.||
7301|109|B|||
7301|110|P|PRECAUTIONS:  Before using tacrolimus, tell your doctor or||
7301|111|P|pharmacist if you are allergic to it; or to other macrolide||
7301|112|P|medications (such as sirolimus); or if you have any other||
7301|113|P|allergies. This product may contain inactive ingredients, which||
7301|114|P|can cause allergic reactions or other problems. Talk to your||
7301|115|P|pharmacist for more details.||
7301|116|P|   Before using this medication, tell your doctor or pharmacist||
7301|117|P|your medical history, especially of: use of light therapy (such||
7301|118|P|as UVA or UVB), cancer (such as skin cancer), other skin||
7301|119|P|conditions (such as Netherton's syndrome, skin infections||
7301|120|P|including herpes, shingles), kidney disease, immune system||
7301|121|P|problems (such as HIV).||
7301|122|P|   This drug may make you more sensitive to the effects of||
7301|123|P|alcohol. Your face or skin may flush red and feel hot. Limit||
7301|124|P|alcoholic beverages.||
7301|125|P|   This medication may make you more sensitive to the sun. Limit||
7301|126|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
7301|127|P|sunscreen and wear protective clothing when outdoors. Tell your||
7301|128|P|doctor right away if you get sunburned or have skin||
7301|129|P|blisters/redness.||
7301|130|P|   Before having surgery, tell your doctor or dentist about all||
7301|131|P|the products you use (including prescription drugs,||
7301|132|P|nonprescription drugs, and herbal products).||
7301|133|P|   During pregnancy, this medication should be used only when||
7301|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
7301|135|P|   It is unknown if this medication passes into breast milk.||
7301|136|P|Consult your doctor before breastfeeding.||
7301|137|B|||
7301|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7301|139|I|medications work or increase your risk for serious side effects.||
7301|140|I|This document does not contain all possible drug interactions.||
7301|141|I|Keep a list of all the products you use (including||
7301|142|I|prescription/nonprescription drugs and herbal products) and share||
7301|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
7301|144|I|the dosage of any medicines without your doctor's approval.||
7301|145|B|||
7301|146|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7301|147|O|has overdosed and has serious symptoms such as passing out or||
7301|148|O|trouble breathing, call 911. Otherwise, call a poison control||
7301|149|O|center right away. US residents can call 1-800-222-1222. Canada||
7301|150|O|residents can call 1-844-764-7669.||
7301|151|B|||
7301|152|N|NOTES:  Do not share this medication with others.||
7301|153|N|   This medication has been prescribed for your current condition||
7301|154|N|only. Do not use it later for another condition unless your||
7301|155|N|doctor tells you to.||
7301|156|N|   Talk with your doctor about other ways to manage your eczema,||
7301|157|N|such as using moisturizers and taking shorter baths/showers.||
7301|158|B|||
7301|159|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7301|160|D|If it is near the time of the next dose, skip the missed dose.||
7301|161|D|Use your next dose at the regular time. Do not double the dose to||
7301|162|D|catch up.||
7301|163|B|||
7301|164|R|STORAGE:  Store at room temperature. Keep all medications away||
7301|165|R|from children and pets.||
7301|166|R|   Do not flush medications down the toilet or pour them into a||
7301|167|R|drain unless instructed to do so. Properly discard this product||
7301|168|R|when it is expired or no longer needed. Consult your pharmacist||
7301|169|R|or local waste disposal company.||
7301|170|B|||
7301|171|A|Information last revised May 2025.||
7301|172|A|Copyright(c) 2025 First Databank, Inc.||
7301|173|B|||
7308|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7308|002|Z|does NOT have all possible information about this product. This||
7308|003|Z|information does not assure that this product is safe, effective,||
7308|004|Z|or appropriate for you. This information is not individual||
7308|005|Z|medical advice and does not substitute for the advice of your||
7308|006|Z|health care professional. Always ask your health care||
7308|007|Z|professional for complete information about this product and your||
7308|008|Z|specific health needs.||
7308|009|B|||
7308|010|T|CLARITHROMYCIN EXTENDED-RELEASE TABLET - ORAL||
7308|011|F|(kla-RITH-roe-MYE-sin)||
7308|012|B|||
7308|013|C|COMMON BRAND NAME(S): Biaxin XL||
7308|014|B|||
7308|015|U|USES:  Clarithromycin is used to treat a wide variety of||
7308|016|U|bacterial respiratory tract infections. Clarithromycin is known||
7308|017|U|as a macrolide antibiotic. It works by stopping the growth of||
7308|018|U|bacteria.||
7308|019|U|   This antibiotic treats only bacterial infections. It will not||
7308|020|U|work for viral infections (such as common cold, flu). Using any||
7308|021|U|antibiotic when it is not needed can cause it to not work for||
7308|022|U|future infections.||
7308|023|B|||
7308|024|H|HOW TO USE:  Take this medication by mouth with food as directed||
7308|025|H|by your doctor, usually once daily. Swallow the tablets whole. Do||
7308|026|H|not crush or chew the tablets. Doing so can release all of the||
7308|027|H|drug at once, increasing the risk of side effects.||
7308|028|H|   For the best effect, take this antibiotic at evenly spaced||
7308|029|H|times. To help you remember, take this medication at the same||
7308|030|H|time(s) every day.||
7308|031|H|   The dosage and length of treatment are based on your medical||
7308|032|H|condition and response to treatment.||
7308|033|H|   Continue to take this medication until the full prescribed||
7308|034|H|amount is finished, even if symptoms disappear after a few days.||
7308|035|H|Stopping the medication too early may result in a return of the||
7308|036|H|infection.||
7308|037|H|   Tell your doctor if your condition lasts or gets worse.||
7308|038|B|||
7308|039|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, and changes in taste||
7308|040|S|may occur. If any of these effects last or get worse, tell your||
7308|041|S|doctor or pharmacist promptly.||
7308|042|S|   A tablet may rarely appear in your stool. This is more likely||
7308|043|S|to occur if you have certain intestinal conditions (such as||
7308|044|S|ileostomy, colostomy, diarrhea). Contact your doctor or||
7308|045|S|pharmacist for further instructions.||
7308|046|S|   Remember that this medication has been prescribed because your||
7308|047|S|doctor has judged that the benefit to you is greater than the||
7308|048|S|risk of side effects. Many people using this medication do not||
7308|049|S|have serious side effects.||
7308|050|S|   Tell your doctor right away if you have any serious side||
7308|051|S|effects, including: signs of liver disease (such as||
7308|052|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
7308|053|S|yellowing eyes/skin, dark urine), hearing loss, mental/mood||
7308|054|S|changes, muscle weakness, eye problems (such as drooping eyelids,||
7308|055|S|blurred vision), trouble speaking.||
7308|056|S|   This medication may rarely cause a severe intestinal condition||
7308|057|S|due to a bacteria called C. difficile. This condition may occur||
7308|058|S|during treatment or weeks to months after treatment has stopped.||
7308|059|S|Tell your doctor right away if you develop: diarrhea that doesn't||
7308|060|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
7308|061|S|stool.||
7308|062|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
7308|063|S|products because they may make symptoms worse.||
7308|064|S|   Use of this medication for prolonged or repeated periods may||
7308|065|S|result in oral thrush or a new yeast infection. Contact your||
7308|066|S|doctor if you notice white patches in your mouth, a change in||
7308|067|S|vaginal discharge, or other new symptoms.||
7308|068|S|   Get medical help right away if you have any very serious side||
7308|069|S|effects, including: severe dizziness, fainting, fast/irregular||
7308|070|S|heartbeat.||
7308|071|S|   A very serious allergic reaction to this drug is rare.||
7308|072|S|However, get medical help right away if you notice any symptoms||
7308|073|S|of a serious allergic reaction, including: fever that doesn't go||
7308|074|S|away, new or worsening lymph node swelling, rash,||
7308|075|S|itching/swelling (especially of the face/tongue/throat), severe||
7308|076|S|dizziness, trouble breathing.||
7308|077|S|   This is not a complete list of possible side effects. If you||
7308|078|S|notice other effects not listed above, contact your doctor or||
7308|079|S|pharmacist.||
7308|080|S|   In the US -||
7308|081|S|   Call your doctor for medical advice about side effects. You||
7308|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7308|083|S|www.fda.gov/medwatch.||
7308|084|S|   In Canada - Call your doctor for medical advice about side||
7308|085|S|effects. You may report side effects to Health Canada at||
7308|086|S|1-866-234-2345.||
7308|087|B|||
7308|088|P|PRECAUTIONS:  Before taking clarithromycin, tell your doctor or||
7308|089|P|pharmacist if you are allergic to it; or to other macrolide||
7308|090|P|antibiotics (such as erythromycin, azithromycin); or if you have||
7308|091|P|any other allergies. This product may contain inactive||
7308|092|P|ingredients, which can cause allergic reactions or other||
7308|093|P|problems. Talk to your pharmacist for more details.||
7308|094|P|   Before using this medication, tell your doctor or pharmacist||
7308|095|P|your medical history, especially of: liver disease (including||
7308|096|P|liver problems with past clarithromycin use), kidney disease,||
7308|097|P|heart disease (coronary artery disease, heart attack), a certain||
7308|098|P|type of muscle disease (myasthenia gravis).||
7308|099|P|   Clarithromycin may cause a condition that affects the heart||
7308|100|P|rhythm (QT prolongation). QT prolongation can rarely cause||
7308|101|P|serious (rarely fatal) fast/irregular heartbeat and other||
7308|102|P|symptoms (such as severe dizziness, fainting) that need medical||
7308|103|P|attention right away.||
7308|104|P|   The risk of QT prolongation may be increased if you have||
7308|105|P|certain medical conditions or are taking other drugs that may||
7308|106|P|cause QT prolongation. Before using clarithromycin, tell your||
7308|107|P|doctor or pharmacist of all the drugs you take and if you have||
7308|108|P|any of the following conditions: certain heart problems (heart||
7308|109|P|failure, slow heartbeat, QT prolongation in the EKG), family||
7308|110|P|history of certain heart problems (QT prolongation in the EKG,||
7308|111|P|sudden cardiac death).||
7308|112|P|   Low levels of potassium or magnesium in the blood may also||
7308|113|P|increase your risk of QT prolongation. This risk may increase if||
7308|114|P|you use certain drugs (such as diuretics/"water pills") or if you||
7308|115|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7308|116|P|Talk to your doctor about using clarithromycin safely.||
7308|117|P|   Clarithromycin may cause live bacterial vaccines (such as||
7308|118|P|typhoid vaccine) to not work well. Tell your health care||
7308|119|P|professional that you are using clarithromycin before having any||
7308|120|P|immunizations/vaccinations.||
7308|121|P|   Before having surgery, tell your doctor or dentist about all||
7308|122|P|the products you use (including prescription drugs,||
7308|123|P|nonprescription drugs, and herbal products).||
7308|124|P|   Older adults may be more sensitive to the side effects of this||
7308|125|P|drug, especially hearing loss and QT prolongation (see above).||
7308|126|P|   During pregnancy, this medication should be used only when||
7308|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
7308|128|P|   This medication passes into breast milk. Consult your doctor||
7308|129|P|before breastfeeding.||
7308|130|B|||
7308|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7308|132|I|medications work or increase your risk for serious side effects.||
7308|133|I|This document does not contain all possible drug interactions.||
7308|134|I|Keep a list of all the products you use (including||
7308|135|I|prescription/nonprescription drugs and herbal products) and share||
7308|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
7308|137|I|the dosage of any medicines without your doctor's approval.||
7308|138|I|   Many drugs besides clarithromycin may affect the heart rhythm||
7308|139|I|(QT prolongation), including amiodarone, disopyramide,||
7308|140|I|dofetilide, pacritinib, pimozide, procainamide, quinidine,||
7308|141|I|sotalol, among others.||
7308|142|I|   Other medications can affect the removal of clarithromycin||
7308|143|I|from your body, which may affect how clarithromycin works.||
7308|144|I|Examples include efavirenz, nevirapine, posaconazole, rifamycins||
7308|145|I|(such as rifabutin), among others.||
7308|146|I|   Clarithromycin can slow down the removal of other medications||
7308|147|I|from your body, which may affect how they work. Examples of||
7308|148|I|affected drugs include colchicine, digoxin, some drugs used to||
7308|149|I|treat erectile dysfunction-ED/pulmonary hypertension (such as||
7308|150|I|sildenafil, tadalafil), ergot alkaloids (such as ergotamine,||
7308|151|I|dihydroergotamine), flibanserin, some statin drugs (such as||
7308|152|I|lovastatin, simvastatin), tamsulosin, tolvaptan, ticagrelor,||
7308|153|I|among others.||
7308|154|B|||
7308|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7308|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7308|157|O|poison control center right away. US residents can call||
7308|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7308|159|B|||
7308|160|N|NOTES:  Do not share this medication with others.||
7308|161|N|   This medication has been prescribed for your current condition||
7308|162|N|only. Do not use it later for another infection unless your||
7308|163|N|doctor tells you to.||
7308|164|N|   Lab and/or medical tests (such as cultures, liver/kidney||
7308|165|N|function) may be done while you are taking this medication. Keep||
7308|166|N|all medical and lab appointments. Consult your doctor for more||
7308|167|N|details.||
7308|168|B|||
7308|169|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7308|170|D|remember. If it is near the time of your next dose, skip the||
7308|171|D|missed dose. Take your next dose at the regular time. Do not||
7308|172|D|double the dose to catch up.||
7308|173|B|||
7308|174|R|STORAGE:  Store at room temperature away from light and moisture.||
7308|175|R|Do not store in the bathroom. Keep all medications away from||
7308|176|R|children and pets.||
7308|177|R|   Do not flush medications down the toilet or pour them into a||
7308|178|R|drain unless instructed to do so. Properly discard this product||
7308|179|R|when it is expired or no longer needed. Consult your pharmacist||
7308|180|R|or local waste disposal company.||
7308|181|B|||
7308|182|A|Information last revised May 2025.||
7308|183|A|Copyright(c) 2025 First Databank, Inc.||
7308|184|B|||
7309|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7309|002|Z|does NOT have all possible information about this product. This||
7309|003|Z|information does not assure that this product is safe, effective,||
7309|004|Z|or appropriate for you. This information is not individual||
7309|005|Z|medical advice and does not substitute for the advice of your||
7309|006|Z|health care professional. Always ask your health care||
7309|007|Z|professional for complete information about this product and your||
7309|008|Z|specific health needs.||
7309|009|B|||
7309|010|T|NATEGLINIDE - ORAL||
7309|011|F|(nah-TEGG-lin-ide)||
7309|012|B|||
7309|013|C|COMMON BRAND NAME(S): Starlix||
7309|014|B|||
7309|015|U|USES:  Nateglinide is used alone or with other medications to||
7309|016|U|control high blood sugar along with a proper diet and exercise||
7309|017|U|program. It is used in people with type 2 diabetes. Controlling||
7309|018|U|high blood sugar helps prevent kidney damage, blindness, nerve||
7309|019|U|problems, loss of limbs, and sexual function problems. Proper||
7309|020|U|control of diabetes may also lessen your risk of a heart attack||
7309|021|U|or stroke. It works by stimulating the body to produce more||
7309|022|U|insulin. Insulin is a natural substance that allows the body to||
7309|023|U|properly use sugar from the diet.||
7309|024|B|||
7309|025|H|HOW TO USE:  Read the Patient Information leaflet if one is||
7309|026|H|available from your pharmacist before you start using nateglinide||
7309|027|H|and each time you get a refill. If you have any questions,||
7309|028|H|consult your doctor or pharmacist.||
7309|029|H|   Take this medication by mouth 1 to 30 minutes before each main||
7309|030|H|meal as directed by your doctor, usually 3 times daily. Take this||
7309|031|H|drug no earlier than 30 minutes before the meal. Do not take a||
7309|032|H|dose of medication if you are skipping that meal.||
7309|033|H|   If you are having liquid meals, a higher dose of this||
7309|034|H|medication may be necessary to control your blood sugar. Consult||
7309|035|H|your doctor for more details.||
7309|036|H|   The dosage is based on your medical condition, number of meals||
7309|037|H|per day, and response to treatment.||
7309|038|H|   Use this medication regularly as directed by your doctor in||
7309|039|H|order to get the most benefit from it. Carefully follow the||
7309|040|H|medication treatment plan, meal plan, and exercise program your||
7309|041|H|doctor has recommended.||
7309|042|H|   Check your blood sugar regularly as directed by your doctor.||
7309|043|H|Keep track of the results, and share them with your doctor. This||
7309|044|H|is very important in order to determine the correct dose. Tell||
7309|045|H|your doctor if your blood sugar measurements are too high or too||
7309|046|H|low. Your treatment plan may need to be changed.||
7309|047|B|||
7309|048|S|SIDE EFFECTS:  Weight gain may occur. If this effect lasts or||
7309|049|S|gets worse, tell your doctor or pharmacist promptly.||
7309|050|S|   Remember that this medication has been prescribed because your||
7309|051|S|doctor has judged that the benefit to you is greater than the||
7309|052|S|risk of side effects. Many people using this medication do not||
7309|053|S|have serious side effects.||
7309|054|S|   Nateglinide can cause low blood sugar (hypoglycemia). This may||
7309|055|S|occur if you do not get enough calories from food or if you do||
7309|056|S|unusually heavy exercise. Symptoms of low blood sugar include||
7309|057|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
7309|058|S|dizziness, or tingling hands/feet. It is a good habit to carry||
7309|059|S|glucose tablets or gel to treat low blood sugar. If you don't||
7309|060|S|have these reliable forms of glucose, rapidly raise your blood||
7309|061|S|sugar by eating a quick source of sugar such as table sugar,||
7309|062|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
7309|063|S|doctor right away about the reaction and the use of this product.||
7309|064|S|To help prevent low blood sugar, eat meals on a regular schedule,||
7309|065|S|and do not skip meals. Check with your doctor or pharmacist to||
7309|066|S|find out what you should do if you miss a meal.||
7309|067|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
7309|068|S|thirst/urination. If these symptoms occur, tell your doctor right||
7309|069|S|away. Your doctor may need to adjust your diabetes medication,||
7309|070|S|exercise program, or diet.||
7309|071|S|   A very serious allergic reaction to this drug is rare.||
7309|072|S|However, get medical help right away if you notice any symptoms||
7309|073|S|of a serious allergic reaction, including: rash, itching/swelling||
7309|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7309|075|S|breathing.||
7309|076|S|   This is not a complete list of possible side effects. If you||
7309|077|S|notice other effects not listed above, contact your doctor or||
7309|078|S|pharmacist.||
7309|079|S|   In the US -||
7309|080|S|   Call your doctor for medical advice about side effects. You||
7309|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7309|082|S|www.fda.gov/medwatch.||
7309|083|S|   In Canada - Call your doctor for medical advice about side||
7309|084|S|effects. You may report side effects to Health Canada at||
7309|085|S|1-866-234-2345.||
7309|086|B|||
7309|087|P|PRECAUTIONS:  Before taking nateglinide, tell your doctor or||
7309|088|P|pharmacist if you are allergic to it; or if you have any other||
7309|089|P|allergies. This product may contain inactive ingredients, which||
7309|090|P|can cause allergic reactions or other problems. Talk to your||
7309|091|P|pharmacist for more details.||
7309|092|P|   Before using this medication, tell your doctor or pharmacist||
7309|093|P|your medical history, especially of: kidney disease, liver||
7309|094|P|disease, gout.||
7309|095|P|   You may experience blurred vision, dizziness, or drowsiness||
7309|096|P|due to extremely low or high blood sugar. Do not drive, use||
7309|097|P|machinery, or do anything that needs alertness or clear vision||
7309|098|P|until you can do it safely.||
7309|099|P|   Limit alcohol while taking this medication because it can||
7309|100|P|increase the risk of developing low blood sugar.||
7309|101|P|   During times of stress, such as fever, infection, injury, or||
7309|102|P|surgery, it may be more difficult to control your blood sugar.||
7309|103|P|Consult your doctor because increased stress may require a change||
7309|104|P|in your treatment plan, medications, or blood sugar testing.||
7309|105|P|   During pregnancy, this medication should be used only when||
7309|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
7309|107|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
7309|108|P|your doctor for managing your blood sugar while pregnant. Your||
7309|109|P|doctor may change your diabetes treatment during your pregnancy||
7309|110|P|(such as diet and medications including insulin).||
7309|111|P|   It is unknown if this drug passes into breast milk. Consult||
7309|112|P|your doctor before breastfeeding.||
7309|113|B|||
7309|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7309|115|I|medications work or increase your risk for serious side effects.||
7309|116|I|This document does not contain all possible drug interactions.||
7309|117|I|Keep a list of all the products you use (including||
7309|118|I|prescription/nonprescription drugs and herbal products) and share||
7309|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
7309|120|I|the dosage of any medicines without your doctor's approval.||
7309|121|I|   Many drugs can affect your blood sugar, making it harder to||
7309|122|I|control. Examples include corticosteroids (such as prednisone),||
7309|123|I|psychiatric medicines (such as olanzapine), fluoroquinolone||
7309|124|I|antibiotics (such as ciprofloxacin), among others. Check your||
7309|125|I|blood sugar regularly as directed and share the results with your||
7309|126|I|doctor. Tell your doctor right away if you have symptoms of high||
7309|127|I|or low blood sugar. (See also Side Effects section.) Your doctor||
7309|128|I|may need to adjust your diabetes medication, exercise program, or||
7309|129|I|diet.||
7309|130|I|   Check the labels on all your nonprescription medicines (such||
7309|131|I|as cough-and-cold products) because they may contain ingredients||
7309|132|I|that could affect your blood sugar. Ask your pharmacist about the||
7309|133|I|safe use of those products.||
7309|134|I|   Beta-blocker medications (such as metoprolol, propranolol,||
7309|135|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
7309|136|I|heartbeat you would usually feel when your blood sugar falls too||
7309|137|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
7309|138|I|dizziness, hunger, or sweating are unaffected by these drugs.||
7309|139|I|   Other medications can affect the results of urine tests for||
7309|140|I|sugar or ketones. Consult your doctor or pharmacist for more||
7309|141|I|information.||
7309|142|B|||
7309|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7309|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7309|145|O|poison control center right away. US residents can call||
7309|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7309|147|O|Symptoms of overdose may include: very fast heartbeat, vision||
7309|148|O|changes, unexplained heavy sweating, agitation, fainting,||
7309|149|O|seizures.||
7309|150|B|||
7309|151|N|NOTES:  Do not share this medication with others.||
7309|152|N|   Attend a diabetes education program to learn more about how to||
7309|153|N|manage your diabetes with medications, diet, exercise, and||
7309|154|N|regular medical exams.||
7309|155|N|   Learn the symptoms of high and low blood sugar and how to||
7309|156|N|treat low blood sugar. Check your blood sugar regularly as||
7309|157|N|directed and share the results with your doctor.||
7309|158|N|   Lab and/or medical tests (such as kidney/liver function,||
7309|159|N|fasting blood glucose, hemoglobin A1c) should be done while you||
7309|160|N|are taking this medication. Keep all medical and lab||
7309|161|N|appointments.||
7309|162|B|||
7309|163|D|MISSED DOSE:  If you miss a dose, skip that dose. Take your next||
7309|164|D|dose with your next meal. Do not double the dose to catch up.||
7309|165|B|||
7309|166|R|STORAGE:  Store at room temperature away from light and moisture.||
7309|167|R|Do not store in the bathroom. Keep all medications away from||
7309|168|R|children and pets.||
7309|169|R|   Do not flush medications down the toilet or pour them into a||
7309|170|R|drain unless instructed to do so. Properly discard this product||
7309|171|R|when it is expired or no longer needed. Consult your pharmacist||
7309|172|R|or local waste disposal company.||
7309|173|B|||
7309|174|M|MEDICAL ALERT:  Your condition can cause complications in a||
7309|175|M|medical emergency. For information about enrolling in MedicAlert,||
7309|176|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7309|177|B|||
7309|178|A|Information last revised November 2025.||
7309|179|A|Copyright(c) 2025 First Databank, Inc.||
7309|180|B|||
7310|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7310|002|Z|does NOT have all possible information about this product. This||
7310|003|Z|information does not assure that this product is safe, effective,||
7310|004|Z|or appropriate for you. This information is not individual||
7310|005|Z|medical advice and does not substitute for the advice of your||
7310|006|Z|health care professional. Always ask your health care||
7310|007|Z|professional for complete information about this product and your||
7310|008|Z|specific health needs.||
7310|009|B|||
7310|010|T|ZOLEDRONIC ACID - INJECTION||
7310|011|F|(ZOLE-eh-dron-ick)||
7310|012|B|||
7310|013|C|COMMON BRAND NAME(S): Zometa||
7310|014|B|||
7310|015|U|USES:  This medication is used to treat high blood calcium levels||
7310|016|U|(hypercalcemia) that may occur with cancer. Zoledronic acid is||
7310|017|U|also used with cancer chemotherapy to treat bone problems that||
7310|018|U|may occur with multiple myeloma and other types of cancer (such||
7310|019|U|as breast, lung) that have spread to the bones. Zoledronic acid||
7310|020|U|belongs to a class of drugs known as bisphosphonates. It lowers||
7310|021|U|high blood calcium levels by reducing the amount of calcium||
7310|022|U|released from your bones into your blood. It also works by||
7310|023|U|slowing the breakdown of your bones by cancer to prevent bone||
7310|024|U|fractures.||
7310|025|B|||
7310|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7310|027|H|from your pharmacist before you start receiving zoledronic acid||
7310|028|H|and each time you get a treatment. If you have any questions, ask||
7310|029|H|your doctor or pharmacist.||
7310|030|H|   This medication is given by injection into a vein as directed||
7310|031|H|by your doctor, usually over at least 15 minutes. The dosage is||
7310|032|H|based on your medical condition and response to treatment.||
7310|033|H|   If you are giving this medication to yourself at home, learn||
7310|034|H|all preparation and usage instructions from your health care||
7310|035|H|professional. Before using, check this product for particles or||
7310|036|H|discoloration. If either is present, do not use the liquid. Learn||
7310|037|H|how to store and discard medical supplies safely.||
7310|038|H|   Avoid mixing zoledronic acid with IV fluids that have calcium||
7310|039|H|in them (such as Ringer's solution, Hartmann's solution,||
7310|040|H|parenteral nutrition-TPN/PPN). Talk to your pharmacist for more||
7310|041|H|details.||
7310|042|H|   For the treatment of high blood calcium levels, fluids are||
7310|043|H|usually given through a vein before you receive this medication.||
7310|044|H|To decrease the chance of kidney problems, drink plenty of fluids||
7310|045|H|during treatment unless otherwise directed by your doctor. It||
7310|046|H|takes at least 7 days after a dose to get the full benefit of||
7310|047|H|this drug. The dose may need to be repeated depending on your||
7310|048|H|blood calcium levels.||
7310|049|H|   For the treatment of multiple myeloma and bone problems caused||
7310|050|H|by the spread of cancer, this medication is given as directed by||
7310|051|H|your doctor, usually every 3 to 4 weeks. You may also be||
7310|052|H|instructed to take calcium and vitamin D supplements each day.||
7310|053|B|||
7310|054|S|SIDE EFFECTS:  Dizziness, headache, tiredness, or flu-like||
7310|055|S|symptoms (such as fever, chills, muscle/joint aches) may occur.||
7310|056|S|If any of these effects last or get worse, tell your doctor or||
7310|057|S|pharmacist promptly.||
7310|058|S|   Remember that this medication has been prescribed because your||
7310|059|S|doctor has judged that the benefit to you is greater than the||
7310|060|S|risk of side effects. Many people using this medication do not||
7310|061|S|have serious side effects.||
7310|062|S|   Tell your doctor right away if you have any serious side||
7310|063|S|effects, including: increased or severe bone/joint/muscle pain,||
7310|064|S|new or unusual hip/thigh/groin pain, jaw/ear pain, eye/vision||
7310|065|S|problems, numbness/tingling, muscle spasms, irregular heartbeat.||
7310|066|S|   Get medical help right away if you have any serious side||
7310|067|S|effects, including: signs of kidney problems (such as change in||
7310|068|S|the amount of urine), seizures.||
7310|069|S|   A very serious allergic reaction to this drug is rare.||
7310|070|S|However, get medical help right away if you notice any symptoms||
7310|071|S|of a serious allergic reaction, including: rash, itching/swelling||
7310|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7310|073|S|breathing.||
7310|074|S|   This is not a complete list of possible side effects. If you||
7310|075|S|notice other effects not listed above, contact your doctor or||
7310|076|S|pharmacist.||
7310|077|S|   In the US -||
7310|078|S|   Call your doctor for medical advice about side effects. You||
7310|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7310|080|S|www.fda.gov/medwatch.||
7310|081|S|   In Canada - Call your doctor for medical advice about side||
7310|082|S|effects. You may report side effects to Health Canada at||
7310|083|S|1-866-234-2345.||
7310|084|B|||
7310|085|P|PRECAUTIONS:  Before using zoledronic acid, tell your doctor or||
7310|086|P|pharmacist if you are allergic to it; or to other bisphosphonates||
7310|087|P|(such as alendronate, risedronate); or if you have any other||
7310|088|P|allergies. This product may contain inactive ingredients, which||
7310|089|P|can cause allergic reactions or other problems. Talk to your||
7310|090|P|pharmacist for more details.||
7310|091|P|   Before using this medication, tell your doctor or pharmacist||
7310|092|P|your medical history, especially of: kidney problems,||
7310|093|P|dehydration, aspirin-sensitive asthma.||
7310|094|P|   Some people using zoledronic acid may have serious jawbone||
7310|095|P|problems. Your doctor should check your mouth before you start||
7310|096|P|this medication. Tell your dentist that you are using this||
7310|097|P|medication before you have any dental work done. To help prevent||
7310|098|P|jawbone problems, have regular dental exams and learn how to keep||
7310|099|P|your teeth and gums healthy. If you have jaw pain, tell your||
7310|100|P|doctor and dentist right away.||
7310|101|P|   Before having any surgery (especially dental procedures), tell||
7310|102|P|your doctor and dentist about this medication and all other||
7310|103|P|products you use (including prescription drugs, nonprescription||
7310|104|P|drugs, and herbal products).||
7310|105|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7310|106|P|can make you more dizzy. Do not drive, use machinery, or do||
7310|107|P|anything that needs alertness until you can do it safely. Limit||
7310|108|P|alcoholic beverages. Talk to your doctor if you are using||
7310|109|P|marijuana (cannabis).||
7310|110|P|   Older adults may be at greater risk for kidney problems while||
7310|111|P|using this drug.||
7310|112|P|   Tell your doctor if you are pregnant or plan to become||
7310|113|P|pregnant. Zoledronic acid may stay in your body for many years.||
7310|114|P|You should not become pregnant while using zoledronic acid.||
7310|115|P|Zoledronic acid may harm an unborn baby. Ask about reliable forms||
7310|116|P|of birth control while using this medication and after the last||
7310|117|P|dose. If you become pregnant, talk to your doctor right away||
7310|118|P|about the risks and benefits of this medication.||
7310|119|P|   It is unknown if this drug passes into breast milk. Because of||
7310|120|P|the possible risk to the infant, breastfeeding is not recommended||
7310|121|P|while using this drug and after stopping treatment. This||
7310|122|P|medication may stay in your body for many years. Consult your||
7310|123|P|doctor before breastfeeding.||
7310|124|B|||
7310|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7310|126|I|medications work or increase your risk for serious side effects.||
7310|127|I|This document does not contain all possible drug interactions.||
7310|128|I|Keep a list of all the products you use (including||
7310|129|I|prescription/nonprescription drugs and herbal products) and share||
7310|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
7310|131|I|the dosage of any medicines without your doctor's approval.||
7310|132|I|   Some products that may interact with this drug include:||
7310|133|I|calcium-containing IV fluids.||
7310|134|I|   There is another zoledronic acid product that is used to||
7310|135|I|prevent or treat bone loss (osteoporosis). That product should||
7310|136|I|not be used together with this medication.||
7310|137|B|||
7310|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7310|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7310|140|O|poison control center right away. US residents can call||
7310|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7310|142|O|Symptoms of overdose may include: change in the amount of urine,||
7310|143|O|muscle spasms, muscle weakness, mental/mood changes, irregular||
7310|144|O|heartbeat, seizures.||
7310|145|B|||
7310|146|N|NOTES:  Lab and/or medical tests (such as calcium and other blood||
7310|147|N|mineral levels, kidney function) will be done before you start||
7310|148|N|using this medication and while you are using it. Keep all||
7310|149|N|medical and lab appointments. Consult your doctor for more||
7310|150|N|details.||
7310|151|B|||
7310|152|D|MISSED DOSE:  It is important to get each dose of this medication||
7310|153|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7310|154|D|right away for a new dosing schedule. Do not double the dose to||
7310|155|D|catch up.||
7310|156|B|||
7310|157|R|STORAGE:  Consult the product instructions and your pharmacist||
7310|158|R|for storage details. Keep all medications away from children and||
7310|159|R|pets.||
7310|160|R|   Do not flush medications down the toilet or pour them into a||
7310|161|R|drain unless instructed to do so. Properly discard this product||
7310|162|R|when it is expired or no longer needed. Consult your pharmacist||
7310|163|R|or local waste disposal company.||
7310|164|B|||
7310|165|A|Information last revised November 2024.||
7310|166|A|Copyright(c) 2025 First Databank, Inc.||
7310|167|B|||
7311|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7311|002|Z|does NOT have all possible information about this product. This||
7311|003|Z|information does not assure that this product is safe, effective,||
7311|004|Z|or appropriate for you. This information is not individual||
7311|005|Z|medical advice and does not substitute for the advice of your||
7311|006|Z|health care professional. Always ask your health care||
7311|007|Z|professional for complete information about this product and your||
7311|008|Z|specific health needs.||
7311|009|B|||
7311|010|T|MELATONIN - ORAL||
7311|011|B|||
7311|012|U|USES:  Melatonin has been used for short-term treatment of||
7311|013|U|trouble sleeping (insomnia) due to sleep cycle disorders and time||
7311|014|U|changes ("jet lag"). This product may help you fall asleep faster||
7311|015|U|and decrease the number of times you awaken during the night. It||
7311|016|U|may also help you sleep for a longer time. Melatonin is a||
7311|017|U|substance that your body normally makes. It is thought to help||
7311|018|U|your body's regular daily cycle, hormone production, and sleep||
7311|019|U|patterns.||
7311|020|U|   Some herbal/diet supplement products have been found to||
7311|021|U|contain possibly harmful impurities/additives. Check with your||
7311|022|U|pharmacist for more details regarding the particular brand you||
7311|023|U|use.||
7311|024|U|   The FDA has not reviewed this product for safety or||
7311|025|U|effectiveness. Consult your doctor or pharmacist for more||
7311|026|U|details.||
7311|027|B|||
7311|028|H|HOW TO USE:  This product is taken by mouth with or without food,||
7311|029|H|usually before bedtime or as directed by the package label.||
7311|030|H|Follow all directions on the product package. If you have any||
7311|031|H|questions, ask your doctor or pharmacist.||
7311|032|H|   Do not take a dose of this drug unless you have time for at||
7311|033|H|least 6 to 8 hours of sleep after taking this medication.||
7311|034|H|   Dosage is based on your age, medical condition, and response||
7311|035|H|to treatment. If you are taking the extended-release tablets, do||
7311|036|H|not crush or chew them. Doing so can release all of the drug at||
7311|037|H|once, increasing the risk of side effects. Swallow the tablets||
7311|038|H|whole.||
7311|039|H|   If you are using the chewable form, chew thoroughly before||
7311|040|H|swallowing.||
7311|041|H|   If you are using a liquid form, carefully measure your dose||
7311|042|H|using a medication-measuring device or spoon. Do not use a||
7311|043|H|household spoon because you may not get the correct dose. Some||
7311|044|H|brands of this medication should be shaken well before each use.||
7311|045|H|   If you are using the rapidly dissolving tablets, dry your||
7311|046|H|hands before handling the tablet. Some brands are meant to be||
7311|047|H|placed on the tongue, while others are placed under the tongue.||
7311|048|H|Follow your brand's directions for placing your dose either on or||
7311|049|H|under the tongue. Allow it to dissolve completely, then swallow||
7311|050|H|it with saliva. You do not need to take this medication with||
7311|051|H|water.||
7311|052|H|   This medication may start to work within 30 minutes. If your||
7311|053|H|condition lasts or gets worse, or if you think you may have a||
7311|054|H|serious medical problem, get medical help right away.||
7311|055|B|||
7311|056|S|SIDE EFFECTS:  Headache, dizziness, shaking, nausea, or abdominal||
7311|057|S|cramps may occur. If any of these effects last or get worse, tell||
7311|058|S|your doctor or pharmacist promptly. This product may also make||
7311|059|S|you drowsy or less alert during the day. Consult your doctor or||
7311|060|S|pharmacist if you have daytime drowsiness.||
7311|061|S|   Tell your doctor right away if you have any serious side||
7311|062|S|effects, including: mental/mood changes (such as depression,||
7311|063|S|confusion).||
7311|064|S|   A very serious allergic reaction to this product is rare.||
7311|065|S|However, get medical help right away if you notice any symptoms||
7311|066|S|of a serious allergic reaction, including: rash, itching/swelling||
7311|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7311|068|S|breathing.||
7311|069|S|   This is not a complete list of possible side effects. If you||
7311|070|S|notice other effects not listed above, contact your doctor or||
7311|071|S|pharmacist.||
7311|072|S|   In the US -||
7311|073|S|   Call your doctor for medical advice about side effects. You||
7311|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7311|075|S|www.fda.gov/medwatch.||
7311|076|S|   In Canada - Call your doctor for medical advice about side||
7311|077|S|effects. You may report side effects to Health Canada at||
7311|078|S|1-866-234-2345.||
7311|079|B|||
7311|080|P|PRECAUTIONS:  Before taking melatonin, tell your doctor or||
7311|081|P|pharmacist if you are allergic to it; or to other ingredients in||
7311|082|P|this product; or if you have any other allergies. This product||
7311|083|P|may contain inactive ingredients, which can cause allergic||
7311|084|P|reactions or other problems. Talk to your pharmacist for more||
7311|085|P|details.||
7311|086|P|   If you have any of the following health problems, consult your||
7311|087|P|doctor or pharmacist before using this product: diabetes, high||
7311|088|P|blood pressure, immune system disorder, liver disease,||
7311|089|P|mental/mood disorder (such as depression), seizure disorder (such||
7311|090|P|as epilepsy).||
7311|091|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7311|092|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7311|093|P|machinery, or do anything that needs alertness until you can do||
7311|094|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
7311|095|P|are using marijuana (cannabis).||
7311|096|P|   Liquid and chewable forms of this product may contain sugar or||
7311|097|P|aspartame. Liquid forms may also contain alcohol. Caution is||
7311|098|P|advised if you have diabetes, alcohol dependence, liver disease,||
7311|099|P|phenylketonuria (PKU), or any other condition that requires you||
7311|100|P|to limit/avoid these substances in your diet. Ask your doctor or||
7311|101|P|pharmacist about using this product safely.||
7311|102|P|   Children may be more sensitive to the side effects of this||
7311|103|P|product, such as changes in sexual development. Consult the||
7311|104|P|doctor for details.||
7311|105|P|   During pregnancy, this medication should be used only when||
7311|106|P|clearly needed. It may have an effect on the release of eggs||
7311|107|P|(ovulation). If you are planning pregnancy, become pregnant, or||
7311|108|P|think you may be pregnant, immediately discuss with your doctor||
7311|109|P|the benefits and risks of using this medication during pregnancy.||
7311|110|P|   This medication passes into breast milk. Consult your doctor||
7311|111|P|before breastfeeding.||
7311|112|B|||
7311|113|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7311|114|I|medications work or increase your risk for serious side effects.||
7311|115|I|This document does not contain all possible drug interactions.||
7311|116|I|Keep a list of all the products you use (including||
7311|117|I|prescription/nonprescription drugs and herbal products) and share||
7311|118|I|it with your doctor and pharmacist. Do not start, stop, or change||
7311|119|I|the dosage of any medicines without your doctor's approval.||
7311|120|I|   Some drugs that may interact with this product are: "blood||
7311|121|I|thinners" (such as warfarin, heparin), blood pressure medications||
7311|122|I|(especially nifedipine), products that contain caffeine||
7311|123|I|(including coffee, tea, some sodas), drugs that may affect your||
7311|124|I|immune system (such as azathioprine, cyclosporine, prednisone),||
7311|125|I|fluvoxamine.||
7311|126|I|   Tell your doctor or pharmacist if you are taking other||
7311|127|I|products that cause drowsiness such as opioid pain or cough||
7311|128|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7311|129|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
7311|130|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7311|131|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7311|132|I|diphenhydramine).||
7311|133|I|   Check the labels on all your medicines (such as allergy or||
7311|134|I|cough-and-cold products) because they may contain ingredients||
7311|135|I|that cause drowsiness. Ask your pharmacist about using those||
7311|136|I|products safely.||
7311|137|B|||
7311|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7311|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7311|140|O|poison control center right away. US residents can call||
7311|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7311|142|B|||
7311|143|N|NOTES:  Keep all medical and lab appointments.||
7311|144|B|||
7311|145|D|MISSED DOSE:  Not applicable.||
7311|146|B|||
7311|147|R|STORAGE:  Refer to storage information printed on the package. If||
7311|148|R|you have any questions about storage, ask your pharmacist. Keep||
7311|149|R|all medications and herbal products away from children and pets.||
7311|150|R|   Do not flush medications down the toilet or pour them into a||
7311|151|R|drain unless instructed to do so. Properly discard this product||
7311|152|R|when it is expired or no longer needed. Consult your pharmacist||
7311|153|R|or local waste disposal company.||
7311|154|B|||
7311|155|A|Information last revised May 2024.||
7311|156|A|Copyright(c) 2025 First Databank, Inc.||
7311|157|B|||
7312|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7312|002|Z|does NOT have all possible information about this product. This||
7312|003|Z|information does not assure that this product is safe, effective,||
7312|004|Z|or appropriate for you. This information is not individual||
7312|005|Z|medical advice and does not substitute for the advice of your||
7312|006|Z|health care professional. Always ask your health care||
7312|007|Z|professional for complete information about this product and your||
7312|008|Z|specific health needs.||
7312|009|B|||
7312|010|T|COENZYME Q10 (ubiquinone, ubidecarenone) - ORAL||
7312|011|B|||
7312|012|U|USES:  Coenzyme Q10 has been used for reducing cell damage that||
7312|013|U|may occur after surgery or treatment with certain anti-cancer||
7312|014|U|drugs. It has also been used for heart problems (such as heart||
7312|015|U|failure), certain muscle disorders (such as muscular dystrophy),||
7312|016|U|and for reducing the number of migraine headaches. If you have or||
7312|017|U|think you have any of the conditions listed above, consult your||
7312|018|U|doctor for advice on proper care and treatment.||
7312|019|U|   Coenzyme Q10 is a substance that your body normally makes.||
7312|020|U|Your body uses it to help keep in good health.||
7312|021|U|   Some herbal/diet supplement products have been found to||
7312|022|U|contain possibly harmful impurities/additives. Check with your||
7312|023|U|pharmacist for more details about the brand you use.||
7312|024|U|   The FDA has not reviewed this product for safety or||
7312|025|U|effectiveness. Consult your doctor or pharmacist for more||
7312|026|U|details.||
7312|027|B|||
7312|028|H|HOW TO USE:  This product is taken by mouth as directed. Follow||
7312|029|H|all directions on the product package. If you have any questions,||
7312|030|H|ask your doctor or pharmacist.||
7312|031|H|   If you are using a liquid or powder form, carefully measure||
7312|032|H|your dose using a medication-measuring device or spoon. Do not||
7312|033|H|use a household spoon because you may not get the correct dose.||
7312|034|H|If your liquid form is a suspension, shake the bottle well before||
7312|035|H|measuring each dose. If your liquid comes in a tube/ampule, take||
7312|036|H|the dose immediately after opening and discard any left over||
7312|037|H|liquid. Follow the manufacturer's directions for mixing the||
7312|038|H|powder form.||
7312|039|H|   If you are using chewable tablets or wafers, chew each dose||
7312|040|H|thoroughly before swallowing.||
7312|041|H|   If you are using a tablet made to dissolve in the mouth, dry||
7312|042|H|your hands before handling the tablet. Place each dose on the||
7312|043|H|tongue and allow to dissolve completely, then swallow it with||
7312|044|H|saliva or water.||
7312|045|H|   Do not crush or chew extended-release tablets. Doing so can||
7312|046|H|release all of the drug at once, increasing the risk of side||
7312|047|H|effects. Also, do not split the tablets unless they have a score||
7312|048|H|line and your doctor or pharmacist tells you to do so. Swallow||
7312|049|H|the whole or split tablet without crushing or chewing.||
7312|050|H|   If your condition lasts or gets worse, or if you think you may||
7312|051|H|have a serious medical problem, get medical help right away.||
7312|052|B|||
7312|053|S|SIDE EFFECTS:  This product usually has very few side effects.||
7312|054|S|Nausea, loss of appetite, upset stomach, or diarrhea may rarely||
7312|055|S|occur. If any of these effects last or get worse, tell your||
7312|056|S|doctor promptly.||
7312|057|S|   A very serious allergic reaction to this product is rare.||
7312|058|S|However, get medical help right away if you notice any symptoms||
7312|059|S|of a serious allergic reaction, including: rash, itching/swelling||
7312|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7312|061|S|breathing.||
7312|062|S|   This is not a complete list of possible side effects. If you||
7312|063|S|notice other effects not listed above, contact your doctor or||
7312|064|S|pharmacist.||
7312|065|S|   In the US -||
7312|066|S|   Call your doctor for medical advice about side effects. You||
7312|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7312|068|S|www.fda.gov/medwatch.||
7312|069|S|   In Canada - Call your doctor for medical advice about side||
7312|070|S|effects. You may report side effects to Health Canada at||
7312|071|S|1-866-234-2345.||
7312|072|B|||
7312|073|P|PRECAUTIONS:  Before taking coenzyme Q10, tell your doctor or||
7312|074|P|pharmacist if you are allergic to it; or if you have any other||
7312|075|P|allergies. This product may contain inactive ingredients, which||
7312|076|P|can cause allergic reactions or other problems. Talk to your||
7312|077|P|pharmacist for more details.||
7312|078|P|   If you have any of the following health problems, consult your||
7312|079|P|doctor or pharmacist before using this product: diabetes, heart||
7312|080|P|disease.||
7312|081|P|   Liquid forms, chewable tablets, or dissolving forms of this||
7312|082|P|product may contain sugar, alcohol, or aspartame. Caution is||
7312|083|P|advised if you have diabetes, alcohol dependence, liver disease,||
7312|084|P|phenylketonuria (PKU), or any other condition that requires you||
7312|085|P|to limit/avoid these substances in your diet. Ask your doctor or||
7312|086|P|pharmacist about using this product safely.||
7312|087|P|   During pregnancy, this product should be used only when||
7312|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
7312|089|P|   It is unknown if this product passes into breast milk. Consult||
7312|090|P|your doctor before breastfeeding.||
7312|091|B|||
7312|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7312|093|I|medications work or increase your risk for serious side effects.||
7312|094|I|This document does not contain all possible drug interactions.||
7312|095|I|Keep a list of all the products you use (including||
7312|096|I|prescription/nonprescription drugs and herbal products) and share||
7312|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
7312|098|I|the dosage of any medicines without your doctor's approval.||
7312|099|I|   Some drugs that may interact with this product are: drugs for||
7312|100|I|high blood pressure, "blood thinners" (such as warfarin), drugs||
7312|101|I|for diabetes, drugs for high cholesterol (such as atorvastatin,||
7312|102|I|lovastatin).||
7312|103|B|||
7312|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7312|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7312|106|O|poison control center right away. US residents can call||
7312|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7312|108|B|||
7312|109|N|NOTES:  Keep all medical and lab appointments.||
7312|110|B|||
7312|111|D|MISSED DOSE:  If you are taking this product on a regular||
7312|112|D|schedule and miss a dose, take it as soon as you remember. If it||
7312|113|D|is near the time of the next dose, skip the missed dose. Take||
7312|114|D|your next dose at the regular time. Do not double the dose to||
7312|115|D|catch up.||
7312|116|B|||
7312|117|R|STORAGE:  Refer to storage information printed on the package.||
7312|118|R|Protect the liquid form of this medication from light. If you||
7312|119|R|have any questions about storage, ask your pharmacist. Keep all||
7312|120|R|medications and herbal products away from children and pets.||
7312|121|R|   Do not flush medications down the toilet or pour them into a||
7312|122|R|drain unless instructed to do so. Properly discard this product||
7312|123|R|when it is expired or no longer needed. Consult your pharmacist||
7312|124|R|or local waste disposal company.||
7312|125|B|||
7312|126|A|Information last revised May 2024.||
7312|127|A|Copyright(c) 2025 First Databank, Inc.||
7312|128|B|||
7315|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7315|002|Z|does NOT have all possible information about this product. This||
7315|003|Z|information does not assure that this product is safe, effective,||
7315|004|Z|or appropriate for you. This information is not individual||
7315|005|Z|medical advice and does not substitute for the advice of your||
7315|006|Z|health care professional. Always ask your health care||
7315|007|Z|professional for complete information about this product and your||
7315|008|Z|specific health needs.||
7315|009|B|||
7315|010|T|FENUGREEK (TRIGONELLA FOENUM-GRAECUM) - ORAL||
7315|011|B|||
7315|012|U|USES:  Fenugreek has been used for controlling high blood sugar||
7315|013|U|in people with diabetes.||
7315|014|U|   Some supplement products have been found to contain possibly||
7315|015|U|harmful impurities/additives. Check with your pharmacist for more||
7315|016|U|details about the brand you use.||
7315|017|U|   The FDA has not reviewed this product for safety or||
7315|018|U|effectiveness. Consult your doctor or pharmacist for more||
7315|019|U|details.||
7315|020|B|||
7315|021|H|HOW TO USE:  Take this product by mouth. Follow all directions on||
7315|022|H|the product package, or take as directed by your doctor. If you||
7315|023|H|have any questions, ask your doctor or pharmacist.||
7315|024|H|   If your condition lasts or gets worse, or if you think you may||
7315|025|H|have a serious medical problem, get medical help right away.||
7315|026|B|||
7315|027|S|SIDE EFFECTS:  Stomach upset, diarrhea, or bloating may occur. If||
7315|028|S|any of these effects last or get worse, tell your doctor or||
7315|029|S|pharmacist promptly.||
7315|030|S|   Tell your doctor right away if you have any serious side||
7315|031|S|effects, including: signs of low blood sugar (such as||
7315|032|S|nervousness, shakiness, fast heartbeat, sweating).||
7315|033|S|   A very serious allergic reaction to this product is rare.||
7315|034|S|However, get medical help right away if you notice any symptoms||
7315|035|S|of a serious allergic reaction, including: rash, itching/swelling||
7315|036|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7315|037|S|breathing.||
7315|038|S|   This is not a complete list of possible side effects. If you||
7315|039|S|notice other effects not listed above, contact your doctor or||
7315|040|S|pharmacist.||
7315|041|S|   In the US -||
7315|042|S|   Call your doctor for medical advice about side effects. You||
7315|043|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7315|044|S|www.fda.gov/medwatch.||
7315|045|S|   In Canada - Call your doctor for medical advice about side||
7315|046|S|effects. You may report side effects to Health Canada at||
7315|047|S|1-866-234-2345.||
7315|048|B|||
7315|049|P|PRECAUTIONS:  Before taking fenugreek, tell your doctor or||
7315|050|P|pharmacist if you are allergic to it; or if you have any other||
7315|051|P|allergies. This product may contain inactive ingredients (such as||
7315|052|P|peanut/soy), which can cause allergic reactions or other||
7315|053|P|problems. Talk to your pharmacist for more details.||
7315|054|P|   Before having surgery, tell your doctor or dentist about all||
7315|055|P|the products you use (including prescription drugs,||
7315|056|P|nonprescription drugs, and herbal products).||
7315|057|P|   Fenugreek is not recommended for use during pregnancy. Consult||
7315|058|P|your doctor for more details.||
7315|059|P|   It is unknown if this product passes into breast milk. Consult||
7315|060|P|your doctor before breastfeeding.||
7315|061|B|||
7315|062|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7315|063|I|medications work or increase your risk for serious side effects.||
7315|064|I|This document does not contain all possible drug interactions.||
7315|065|I|Keep a list of all the products you use (including||
7315|066|I|prescription/nonprescription drugs and herbal products) and share||
7315|067|I|it with your doctor and pharmacist. Do not start, stop, or change||
7315|068|I|the dosage of any medicines without your doctor's approval.||
7315|069|I|   Some drugs that may interact with this product include: "blood||
7315|070|I|thinners" (such as warfarin).||
7315|071|B|||
7315|072|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7315|073|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7315|074|O|poison control center right away. US residents can call||
7315|075|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7315|076|B|||
7315|077|N|NOTES:  Keep all medical and lab appointments.||
7315|078|B|||
7315|079|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7315|080|D|remember. If it is near the time of the next dose, skip the||
7315|081|D|missed dose. Take your next dose at the regular time. Do not||
7315|082|D|double the dose to catch up.||
7315|083|B|||
7315|084|R|STORAGE:  Refer to storage information printed on the package. If||
7315|085|R|you have any questions about storage, ask your pharmacist. Keep||
7315|086|R|all medications and herbal products away from children and pets.||
7315|087|R|   Do not flush medications down the toilet or pour them into a||
7315|088|R|drain unless instructed to do so. Properly discard this product||
7315|089|R|when it is expired or no longer needed. Consult your pharmacist||
7315|090|R|or local waste disposal company.||
7315|091|B|||
7315|092|A|Information last revised May 2024.||
7315|093|A|Copyright(c) 2025 First Databank, Inc.||
7315|094|B|||
7317|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7317|002|Z|does NOT have all possible information about this product. This||
7317|003|Z|information does not assure that this product is safe, effective,||
7317|004|Z|or appropriate for you. This information is not individual||
7317|005|Z|medical advice and does not substitute for the advice of your||
7317|006|Z|health care professional. Always ask your health care||
7317|007|Z|professional for complete information about this product and your||
7317|008|Z|specific health needs.||
7317|009|B|||
7317|010|T|LEVOFLOXACIN DROPS - OPHTHALMIC||
7317|011|F|(LEE-voe-FLOX-a-sin)||
7317|012|B|||
7317|013|C|COMMON BRAND NAME(S): Quixin||
7317|014|B|||
7317|015|U|USES:  This medication is used to treat bacterial eye infections.||
7317|016|U|Levofloxacin belongs to a class of drugs known as quinolone||
7317|017|U|antibiotics. It works by stopping the growth of bacteria.||
7317|018|U|   This medication treats only bacterial eye infections. It will||
7317|019|U|not work for other types of eye infections. Using any antibiotic||
7317|020|U|when it is not needed can cause it to not work for future||
7317|021|U|infections.||
7317|022|B|||
7317|023|H|HOW TO USE:  This medication is applied to the eye(s) as directed||
7317|024|H|by your doctor. To apply eye drops, wash hands first. To avoid||
7317|025|H|contamination, do not touch the dropper tip or let it touch your||
7317|026|H|eye or any other surface.||
7317|027|H|   Do not wear contact lenses while you are using this medicine.||
7317|028|H|Sterilize contact lenses according to the manufacturer's||
7317|029|H|directions, and check with your doctor before you begin using||
7317|030|H|them again.||
7317|031|H|   Tilt your head back, look upward, and pull down the lower||
7317|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
7317|033|H|and place one drop into the pouch. Look downward, gently close||
7317|034|H|your eyes, and place one finger at the corner of your eye (near||
7317|035|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
7317|036|H|opening your eyes. This will prevent the medication from draining||
7317|037|H|out. Try not to blink or rub your eye. Repeat these steps if your||
7317|038|H|dose is for more than one drop. If directed to use this||
7317|039|H|medication in both eyes, repeat these steps for your other eye.||
7317|040|H|Do not rinse the dropper. Replace the dropper cap after each use.||
7317|041|H|   If you are using another kind of eye medication (such as drops||
7317|042|H|or ointments), wait at least 5 minutes before applying other||
7317|043|H|medications. Use eye drops before eye ointments to allow the||
7317|044|H|drops to enter the eye.||
7317|045|H|   Wait several minutes for your vision to clear before driving||
7317|046|H|or operating machinery.||
7317|047|H|   Use this medication regularly to get the most benefit from it.||
7317|048|H|To help you remember, use it at the same time(s) each day.||
7317|049|H|Continue to use this medication for the full time prescribed,||
7317|050|H|even if symptoms disappear after a few days. Stopping the||
7317|051|H|medication too early may result in a return of the infection.||
7317|052|H|   Tell your doctor if your condition lasts or gets worse.||
7317|053|B|||
7317|054|S|SIDE EFFECTS:  Temporary blurred or decreased vision, temporary||
7317|055|S|stinging/burning/pain in the eyes, feeling as if something is in||
7317|056|S|the eye, fever, headache, sore throat, or sensitivity of the eyes||
7317|057|S|to light may occur. If any of these effects last or get worse,||
7317|058|S|tell your doctor or pharmacist promptly.||
7317|059|S|   Remember that this medication has been prescribed because your||
7317|060|S|doctor has judged that the benefit to you is greater than the||
7317|061|S|risk of side effects. Many people using this medication do not||
7317|062|S|have serious side effects.||
7317|063|S|   A very serious allergic reaction to this drug is rare.||
7317|064|S|However, get medical help right away if you notice any symptoms||
7317|065|S|of a serious allergic reaction, including: rash, itching/swelling||
7317|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7317|067|S|breathing.||
7317|068|S|   This is not a complete list of possible side effects. If you||
7317|069|S|notice other effects not listed above, contact your doctor or||
7317|070|S|pharmacist.||
7317|071|S|   In the US -||
7317|072|S|   Call your doctor for medical advice about side effects. You||
7317|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7317|074|S|www.fda.gov/medwatch.||
7317|075|S|   In Canada - Call your doctor for medical advice about side||
7317|076|S|effects. You may report side effects to Health Canada at||
7317|077|S|1-866-234-2345.||
7317|078|B|||
7317|079|P|PRECAUTIONS:  Before using levofloxacin, tell your doctor or||
7317|080|P|pharmacist if you are allergic to it; or to other quinolone||
7317|081|P|antibiotics (such as ciprofloxacin, norfloxacin, ofloxacin); or||
7317|082|P|if you have any other allergies. This product may contain||
7317|083|P|inactive ingredients (such as preservatives like benzalkonium||
7317|084|P|chloride), which can cause allergic reactions or other problems.||
7317|085|P|Talk to your pharmacist for more details.||
7317|086|P|   Before using this medication, tell your doctor or pharmacist||
7317|087|P|your medical history, especially of: other eye problems.||
7317|088|P|   After you apply this drug, your vision may become temporarily||
7317|089|P|blurred. Do not drive, use machinery, or do anything that needs||
7317|090|P|clear vision until you can do it safely.||
7317|091|P|   Before having surgery, tell your doctor or dentist about all||
7317|092|P|the products you use (including prescription drugs,||
7317|093|P|nonprescription drugs, and herbal products).||
7317|094|P|   During pregnancy, this medication should be used only when||
7317|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
7317|096|P|   It is unknown if this form of levofloxacin passes into breast||
7317|097|P|milk. The form taken by mouth passes into breast milk. Consult||
7317|098|P|your doctor before breastfeeding.||
7317|099|B|||
7317|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7317|101|I|medications work or increase your risk for serious side effects.||
7317|102|I|This document does not contain all possible drug interactions.||
7317|103|I|Keep a list of all the products you use (including||
7317|104|I|prescription/nonprescription drugs and herbal products) and share||
7317|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
7317|106|I|the dosage of any medicines without your doctor's approval.||
7317|107|B|||
7317|108|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7317|109|O|has overdosed and has serious symptoms such as passing out or||
7317|110|O|trouble breathing, call 911. Otherwise, call a poison control||
7317|111|O|center right away. US residents can call 1-800-222-1222. Canada||
7317|112|O|residents can call 1-844-764-7669.||
7317|113|B|||
7317|114|N|NOTES:  Do not share this medication with others.||
7317|115|N|   This medication has been prescribed for your current condition||
7317|116|N|only. Throw away the unused medication after treatment is||
7317|117|N|completed. Do not use it later for another infection unless your||
7317|118|N|doctor tells you to.||
7317|119|B|||
7317|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7317|121|D|If it is near the time of the next dose, skip the missed dose.||
7317|122|D|Use your next dose at the regular time. Do not double the dose to||
7317|123|D|catch up.||
7317|124|B|||
7317|125|R|STORAGE:  Store at room temperature. Keep all medications away||
7317|126|R|from children and pets.||
7317|127|R|   Do not flush medications down the toilet or pour them into a||
7317|128|R|drain unless instructed to do so. Properly discard this product||
7317|129|R|when it is expired or no longer needed. Consult your pharmacist||
7317|130|R|or local waste disposal company.||
7317|131|B|||
7317|132|A|Information last revised November 2024.||
7317|133|A|Copyright(c) 2025 First Databank, Inc.||
7317|134|B|||
7321|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7321|002|Z|does NOT have all possible information about this product. This||
7321|003|Z|information does not assure that this product is safe, effective,||
7321|004|Z|or appropriate for you. This information is not individual||
7321|005|Z|medical advice and does not substitute for the advice of your||
7321|006|Z|health care professional. Always ask your health care||
7321|007|Z|professional for complete information about this product and your||
7321|008|Z|specific health needs.||
7321|009|B|||
7321|010|T|POLYMYXIN B/TRIMETHOPRIM - OPHTHALMIC||
7321|011|F|(paw-lee-MIX-in B SUL-fate/try-METH-oh-prim)||
7321|012|B|||
7321|013|C|COMMON BRAND NAME(S): Polytrim||
7321|014|B|||
7321|015|U|USES:  This medication is used to treat bacterial infections||
7321|016|U|(such as blepharitis, conjunctivitis) of the eye. It contains 2||
7321|017|U|antibiotics. Polymyxin B works by killing the bacteria.||
7321|018|U|Trimethoprim works by stopping the growth of the bacteria.||
7321|019|U|   This medication treats only bacterial eye infections. It will||
7321|020|U|not work for other types of eye infections. Unnecessary use or||
7321|021|U|misuse of any antibiotic can lead to its decreased effectiveness.||
7321|022|B|||
7321|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
7321|024|H|directed by your doctor, usually every 3 hours.||
7321|025|H|   To apply eye drops, wash your hands first. To avoid||
7321|026|H|contamination, do not touch the dropper tip or let it touch your||
7321|027|H|eye or any other surface. Use in the eyes only. Do not swallow or||
7321|028|H|inject.||
7321|029|H|   Do not wear contact lenses while you are using this||
7321|030|H|medication. Sterilize contact lenses according to the||
7321|031|H|manufacturer's directions, and check with your doctor before you||
7321|032|H|begin using them again.||
7321|033|H|   Tilt your head back, look upward, and pull down the lower||
7321|034|H|eyelid to make a pouch. Hold the dropper directly over your eye||
7321|035|H|and place one drop into the pouch as directed by your doctor.||
7321|036|H|Look downward, gently close your eyes, and place one finger at||
7321|037|H|the corner of your eye (near the nose). Apply gentle pressure for||
7321|038|H|1 to 2 minutes before opening your eyes. This will prevent the||
7321|039|H|medication from draining out. Try not to blink or rub your eye.||
7321|040|H|Repeat these steps if your dose is for more than one drop. If||
7321|041|H|directed to use this medication in both eyes, repeat these steps||
7321|042|H|for your other eye. Do not rinse the dropper. Replace the dropper||
7321|043|H|cap after each use.||
7321|044|H|   Dosage is based on your medical condition and response to||
7321|045|H|treatment. Your doctor may direct you to use this medication more||
7321|046|H|often at first, then use it less often as the infection improves.||
7321|047|H|Follow your doctor's directions carefully.||
7321|048|H|   Tell your doctor if you are using other eye products (such as||
7321|049|H|drops, ointments, artificial tears). Some ingredients in these||
7321|050|H|products may interact with this medication and prevent it from||
7321|051|H|working. Ask your doctor or pharmacist if you can use these eye||
7321|052|H|products while using this medication and how long to wait before||
7321|053|H|applying the other products. Use eye drops before eye ointments||
7321|054|H|to allow the drops to enter the eye.||
7321|055|H|   Wait several minutes for your vision to clear before driving||
7321|056|H|or operating machinery.||
7321|057|H|   Use this medication regularly in order to get the most benefit||
7321|058|H|from it. To help you remember, use it at the same times each day.||
7321|059|H|Continue to use this medication for the full time prescribed,||
7321|060|H|even if symptoms disappear after a few days. Stopping the||
7321|061|H|medication too early may result in a return of the infection.||
7321|062|H|   Tell your doctor if your condition lasts or gets worse.||
7321|063|B|||
7321|064|S|SIDE EFFECTS:  Temporary eye stinging/burning/redness/itchiness||
7321|065|S|or temporary blurred vision may occur. If any of these effects||
7321|066|S|last or get worse, tell your doctor or pharmacist promptly.||
7321|067|S|   Remember that this medication has been prescribed because your||
7321|068|S|doctor has judged that the benefit to you is greater than the||
7321|069|S|risk of side effects. Many people using this medication do not||
7321|070|S|have serious side effects.||
7321|071|S|   Use of this medication for prolonged or repeated periods may||
7321|072|S|result in other types of eye infections, including fungal||
7321|073|S|infections. Contact your doctor if you notice new eye symptoms||
7321|074|S|(such as pain, swelling, thick discharge or pus).||
7321|075|S|   A very serious allergic reaction to this drug is rare.||
7321|076|S|However, get medical help right away if you notice any symptoms||
7321|077|S|of a serious allergic reaction, including: rash, itching/swelling||
7321|078|S|(especially of the eyes/face/tongue/throat), severe dizziness,||
7321|079|S|trouble breathing.||
7321|080|S|   This is not a complete list of possible side effects. If you||
7321|081|S|notice other effects not listed above, contact your doctor or||
7321|082|S|pharmacist.||
7321|083|S|   In the US -||
7321|084|S|   Call your doctor for medical advice about side effects. You||
7321|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7321|086|S|www.fda.gov/medwatch.||
7321|087|S|   In Canada - Call your doctor for medical advice about side||
7321|088|S|effects. You may report side effects to Health Canada at||
7321|089|S|1-866-234-2345.||
7321|090|B|||
7321|091|P|PRECAUTIONS:  Before using polymyxin B/trimethoprim, tell your||
7321|092|P|doctor or pharmacist if you are allergic to it; or if you have||
7321|093|P|any other allergies. This product may contain inactive||
7321|094|P|ingredients, which can cause allergic reactions or other||
7321|095|P|problems. Talk to your pharmacist for more details.||
7321|096|P|   Before using this medication, tell your doctor or pharmacist||
7321|097|P|your medical history.||
7321|098|P|   After you apply this drug, your vision may become temporarily||
7321|099|P|blurred. Do not drive, use machinery, or do anything that needs||
7321|100|P|clear vision until you can do it safely.||
7321|101|P|   Before having surgery, tell your doctor or dentist about all||
7321|102|P|the products you use (including prescription drugs,||
7321|103|P|nonprescription drugs, and herbal products).||
7321|104|P|   During pregnancy, this medication should be used only when||
7321|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
7321|106|P|   It is unknown if this medication passes into breast milk when||
7321|107|P|used in the eye. It is unlikely to harm a nursing infant. Consult||
7321|108|P|your doctor before breastfeeding.||
7321|109|B|||
7321|110|I|DRUG INTERACTIONS:  See also How to Use section.||
7321|111|I|   Drug interactions may change how your medications work or||
7321|112|I|increase your risk for serious side effects. This document does||
7321|113|I|not contain all possible drug interactions. Keep a list of all||
7321|114|I|the products you use (including prescription/nonprescription||
7321|115|I|drugs and herbal products) and share it with your doctor and||
7321|116|I|pharmacist. Do not start, stop, or change the dosage of any||
7321|117|I|medicines without your doctor's approval.||
7321|118|B|||
7321|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
7321|120|O|has overdosed and has serious symptoms such as passing out or||
7321|121|O|trouble breathing, call 911. Otherwise, call a poison control||
7321|122|O|center right away. US residents can call 1-800-222-1222. Canada||
7321|123|O|residents can call 1-844-764-7669.||
7321|124|B|||
7321|125|N|NOTES:  Do not share this medication with others.||
7321|126|N|   This medication has been prescribed for your current condition||
7321|127|N|only. Do not use it later for another infection unless your||
7321|128|N|doctor tells you to.||
7321|129|B|||
7321|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7321|131|D|If it is near the time of the next dose, skip the missed dose.||
7321|132|D|Use your next dose at the regular time. Do not double the dose to||
7321|133|D|catch up.||
7321|134|B|||
7321|135|R|STORAGE:  Store at room temperature. Different brands of this||
7321|136|R|medication have different storage needs. Check the product||
7321|137|R|package for instructions on how to store your brand, or ask your||
7321|138|R|pharmacist. Do not freeze. Keep all medications away from||
7321|139|R|children and pets.||
7321|140|R|   Do not flush medications down the toilet or pour them into a||
7321|141|R|drain unless instructed to do so. Properly discard this product||
7321|142|R|when it is expired or no longer needed. Consult your pharmacist||
7321|143|R|or local waste disposal company.||
7321|144|B|||
7321|145|A|Information last revised May 2024.||
7321|146|A|Copyright(c) 2025 First Databank, Inc.||
7321|147|B|||
7327|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7327|002|Z|does NOT have all possible information about this product. This||
7327|003|Z|information does not assure that this product is safe, effective,||
7327|004|Z|or appropriate for you. This information is not individual||
7327|005|Z|medical advice and does not substitute for the advice of your||
7327|006|Z|health care professional. Always ask your health care||
7327|007|Z|professional for complete information about this product and your||
7327|008|Z|specific health needs.||
7327|009|B|||
7327|010|T|BUSULFAN - INJECTION||
7327|011|F|(bue-SUL-fan)||
7327|012|B|||
7327|013|C|COMMON BRAND NAME(S): Busulfex||
7327|014|B|||
7327|015|W|WARNING:  This medication decreases bone marrow function, an||
7327|016|W|effect that may lead to a low number of blood cells such as red||
7327|017|W|cells, white cells, and platelets. This effect can cause anemia,||
7327|018|W|decrease your body's ability to fight an infection, or cause you||
7327|019|W|to bruise or bleed more easily. Tell your doctor right away if||
7327|020|W|you develop any of the following symptoms: signs of an infection||
7327|021|W|(such as sore throat that doesn't go away, fever, chills), easy||
7327|022|W|bruising/bleeding, pale skin, unusual tiredness.||
7327|023|W|   Your doctor will monitor you closely while you are using this||
7327|024|W|medication. Keep all medical and lab appointments.||
7327|025|B|||
7327|026|U|USES:  Busulfan is used as a pretreatment for patients who are||
7327|027|U|undergoing stem cell transplant for chronic myelogenous leukemia||
7327|028|U|(CML).||
7327|029|B|||
7327|030|H|HOW TO USE:  This medication is given by injection into a vein||
7327|031|H|over 2 hours by a health care professional. It is given as||
7327|032|H|directed by your doctor, usually every 6 hours. While you receive||
7327|033|H|busulfan, your doctor may also prescribe other medications to||
7327|034|H|help prevent seizures and nausea/vomiting caused by the||
7327|035|H|medication.||
7327|036|H|   The dosage is based on your weight, medical condition, lab||
7327|037|H|tests, and response to treatment.||
7327|038|B|||
7327|039|S|SIDE EFFECTS:  See also Warning section.||
7327|040|S|   Nausea, vomiting, diarrhea, constipation, loss of appetite,||
7327|041|S|mouth sores, stomach/abdominal pain, dizziness, swelling||
7327|042|S|ankles/feet/hand, flushing, headache, or trouble sleeping may||
7327|043|S|occur. If any of these effects last or get worse, tell your||
7327|044|S|doctor or pharmacist promptly.||
7327|045|S|   Nausea and vomiting can be severe. In some cases, your doctor||
7327|046|S|may prescribe medication to prevent or relieve nausea and||
7327|047|S|vomiting. Eating several small meals, not eating before||
7327|048|S|treatment, or limiting activity may help lessen some of these||
7327|049|S|effects.||
7327|050|S|   Many people using this medication may have serious side||
7327|051|S|effects. However, you have been prescribed this drug because your||
7327|052|S|doctor has judged that the benefit to you is greater than the||
7327|053|S|risk of side effects. Careful monitoring by your doctor may||
7327|054|S|decrease your risk.||
7327|055|S|   Tell your doctor right away if you have any serious side||
7327|056|S|effects, including: signs of liver disease (such as||
7327|057|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain,||
7327|058|S|yellowing skin/eyes, dark urine), mental/mood changes (such as||
7327|059|S|depression, hallucinations, anxiety, confusion), muscle cramps,||
7327|060|S|increased thirst/urination, fast/irregular heartbeat, coughing up||
7327|061|S|blood, bloody urine, seizures, pain/redness/swelling at injection||
7327|062|S|site, fainting.||
7327|063|S|   Busulfan has rarely caused very serious (possibly fatal) lung||
7327|064|S|disease. Tell your doctor right away if you develop symptoms of||
7327|065|S|lung disease, including cough that doesn't go away, chest pain,||
7327|066|S|shortness of breath.||
7327|067|S|   Busulfan may cause other cancers (such as acute leukemia,||
7327|068|S|tumors). Consult your doctor for more details. Tell your doctor||
7327|069|S|right away if you notice any symptoms of cancer, including||
7327|070|S|unusual lumps, sudden weight loss.||
7327|071|S|   A very serious allergic reaction to this drug is rare.||
7327|072|S|However, get medical help right away if you notice any symptoms||
7327|073|S|of a serious allergic reaction, including: rash, itching/swelling||
7327|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7327|075|S|breathing.||
7327|076|S|   This is not a complete list of possible side effects. If you||
7327|077|S|notice other effects not listed above, contact your doctor or||
7327|078|S|pharmacist.||
7327|079|S|   In the US -||
7327|080|S|   Call your doctor for medical advice about side effects. You||
7327|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7327|082|S|www.fda.gov/medwatch.||
7327|083|S|   In Canada - Call your doctor for medical advice about side||
7327|084|S|effects. You may report side effects to Health Canada at||
7327|085|S|1-866-234-2345.||
7327|086|B|||
7327|087|P|PRECAUTIONS:  Before receiving busulfan, tell your doctor or||
7327|088|P|pharmacist if you are allergic to it; or if you have any other||
7327|089|P|allergies. This product may contain inactive ingredients, which||
7327|090|P|can cause allergic reactions or other problems. Talk to your||
7327|091|P|pharmacist for more details.||
7327|092|P|   Before using this medication, tell your doctor or pharmacist||
7327|093|P|your medical history, especially of: blood/bone marrow disorders||
7327|094|P|(such as bone marrow suppression, neutropenia, thrombocytopenia,||
7327|095|P|anemia), brain disorders (such as seizures, head injury).||
7327|096|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7327|097|P|can make you more dizzy. Do not drive, use machinery, or do||
7327|098|P|anything that needs alertness until you can do it safely. Limit||
7327|099|P|alcoholic beverages. Talk to your doctor if you are using||
7327|100|P|marijuana (cannabis).||
7327|101|P|   Busulfan can make you more likely to get infections or may||
7327|102|P|make current infections worse. Stay away from anyone who has an||
7327|103|P|infection that may easily spread (such as chickenpox, COVID-19,||
7327|104|P|measles, flu). Talk to your doctor if you have been exposed to an||
7327|105|P|infection or for more details.||
7327|106|P|   Tell your health care professional that you are using busulfan||
7327|107|P|before having any immunizations/vaccinations. Avoid contact with||
7327|108|P|people who have recently received live vaccines (such as flu||
7327|109|P|vaccine inhaled through the nose).||
7327|110|P|   To lower the chance of getting cut, bruised, or injured, use||
7327|111|P|caution with sharp objects like razors and nail cutters, and||
7327|112|P|avoid activities such as contact sports.||
7327|113|P|   Before having surgery, tell your doctor or dentist about all||
7327|114|P|the products you use (including prescription drugs,||
7327|115|P|nonprescription drugs, and herbal products).||
7327|116|P|   This medication can affect fertility in both males and||
7327|117|P|females. Ask your doctor for more details.||
7327|118|P|   Tell your doctor if you are pregnant or plan to become||
7327|119|P|pregnant. You should not become pregnant while using busulfan.||
7327|120|P|Busulfan may harm an unborn baby. Women using this medication||
7327|121|P|should ask about reliable forms of birth control during treatment||
7327|122|P|and for at least 6 months after the last dose. Men using this||
7327|123|P|medication should ask about reliable forms of birth control||
7327|124|P|during treatment and for at least 3 months after the last dose.||
7327|125|P|If you or your partner becomes pregnant, talk to your doctor||
7327|126|P|right away about the risks and benefits of this medication.||
7327|127|P|   It is unknown if this drug passes into breast milk. Because of||
7327|128|P|the possible risk to the infant, breastfeeding is not recommended||
7327|129|P|while using this drug. Consult your doctor before breastfeeding.||
7327|130|B|||
7327|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7327|132|I|medications work or increase your risk for serious side effects.||
7327|133|I|This document does not contain all possible drug interactions.||
7327|134|I|Keep a list of all the products you use (including||
7327|135|I|prescription/nonprescription drugs and herbal products) and share||
7327|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
7327|137|I|the dosage of any medicines without your doctor's approval.||
7327|138|B|||
7327|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7327|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7327|141|O|poison control center right away. US residents can call||
7327|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7327|143|B|||
7327|144|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
7327|145|N|busulfan blood levels, liver function) must be done while you are||
7327|146|N|using this medication. Keep all medical and lab appointments.||
7327|147|N|Consult your doctor for more details.||
7327|148|B|||
7327|149|D|MISSED DOSE:  It is important to get each dose of this medication||
7327|150|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7327|151|D|right away for a new dosing schedule.||
7327|152|B|||
7327|153|R|STORAGE:  Not applicable. This medication is given in a hospital||
7327|154|R|and will not be stored at home.||
7327|155|B|||
7327|156|M|MEDICAL ALERT:  Your condition can cause complications in a||
7327|157|M|medical emergency. For information about enrolling in MedicAlert,||
7327|158|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7327|159|B|||
7327|160|A|Information last revised May 2024.||
7327|161|A|Copyright(c) 2025 First Databank, Inc.||
7327|162|B|||
7332|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7332|002|Z|does NOT have all possible information about this product. This||
7332|003|Z|information does not assure that this product is safe, effective,||
7332|004|Z|or appropriate for you. This information is not individual||
7332|005|Z|medical advice and does not substitute for the advice of your||
7332|006|Z|health care professional. Always ask your health care||
7332|007|Z|professional for complete information about this product and your||
7332|008|Z|specific health needs.||
7332|009|B|||
7332|010|T|SODIUM CHLORIDE SOLUTION - INTRAVENOUS||
7332|011|F|(SOE-dee-um KLOR-ide)||
7332|012|B|||
7332|013|U|USES:  This solution is used to supply water and salt (sodium||
7332|014|U|chloride) to the body. Sodium chloride solution may also be mixed||
7332|015|U|with other medications given by injection into a vein.||
7332|016|B|||
7332|017|H|HOW TO USE:  This solution is usually given by injection into a||
7332|018|H|vein as directed by your doctor. It may be given in the hospital,||
7332|019|H|in a clinic, or at home.||
7332|020|H|   If you are using this product at home, learn all preparation||
7332|021|H|and usage instructions from your health care professional. Before||
7332|022|H|using, check this product for particles or discoloration. If||
7332|023|H|either is present, do not use the liquid. If you are mixing this||
7332|024|H|solution with another medication, ask your doctor or pharmacist||
7332|025|H|if it is proper to mix it with the medication. Learn how to store||
7332|026|H|and discard medical supplies safely.||
7332|027|H|   The dosage is based on your age, weight, medical condition,||
7332|028|H|and response to treatment.||
7332|029|B|||
7332|030|S|SIDE EFFECTS:  Redness, pain, or swelling at the injection site||
7332|031|S|may occur. If any of these effects last or get worse, tell your||
7332|032|S|doctor or pharmacist promptly.||
7332|033|S|   Remember that this medication has been prescribed because your||
7332|034|S|doctor has judged that the benefit to you is greater than the||
7332|035|S|risk of side effects. Many people using this medication do not||
7332|036|S|have serious side effects.||
7332|037|S|   Tell your doctor right away if you have any serious side||
7332|038|S|effects, including: swelling hands/ankles/feet, muscle cramps,||
7332|039|S|unusual weakness, headache, nausea, extreme drowsiness,||
7332|040|S|mental/mood changes (such as confusion), seizures.||
7332|041|S|   A very serious allergic reaction to this drug is rare.||
7332|042|S|However, get medical help right away if you notice any symptoms||
7332|043|S|of a serious allergic reaction, including: rash, itching/swelling||
7332|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7332|045|S|breathing.||
7332|046|S|   This is not a complete list of possible side effects. If you||
7332|047|S|notice other effects not listed above, contact your doctor or||
7332|048|S|pharmacist.||
7332|049|S|   In the US -||
7332|050|S|   Call your doctor for medical advice about side effects. You||
7332|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7332|052|S|www.fda.gov/medwatch.||
7332|053|S|   In Canada - Call your doctor for medical advice about side||
7332|054|S|effects. You may report side effects to Health Canada at||
7332|055|S|1-866-234-2345.||
7332|056|B|||
7332|057|P|PRECAUTIONS:  Before using this product, tell your doctor or||
7332|058|P|pharmacist if you have any allergies. This product may contain||
7332|059|P|inactive ingredients, which can cause allergic reactions or other||
7332|060|P|problems. Talk to your pharmacist for more details.||
7332|061|P|   Before using this product, tell your doctor or pharmacist your||
7332|062|P|medical history, especially of: kidney problems, heart problems||
7332|063|P|(such as heart failure), body water/salt imbalance.||
7332|064|P|   Before having surgery, tell your doctor or dentist about all||
7332|065|P|the products you use (including prescription drugs,||
7332|066|P|nonprescription drugs, and herbal products).||
7332|067|P|   This solution is safe to use during pregnancy or while||
7332|068|P|breastfeeding when used as directed.||
7332|069|B|||
7332|070|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7332|071|I|medications work or increase your risk for serious side effects.||
7332|072|I|This document does not contain all possible drug interactions.||
7332|073|I|Keep a list of all the products you use (including||
7332|074|I|prescription/nonprescription drugs and herbal products) and share||
7332|075|I|it with your doctor and pharmacist. Do not start, stop, or change||
7332|076|I|the dosage of any medicines without your doctor's approval.||
7332|077|B|||
7332|078|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7332|079|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7332|080|O|poison control center right away. US residents can call||
7332|081|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7332|082|B|||
7332|083|N|NOTES:  Do not share this product with others.||
7332|084|N|   Lab and/or medical tests (such as kidney function) may be done||
7332|085|N|while you are using this medication. Keep all medical and lab||
7332|086|N|appointments. Consult your doctor for more details.||
7332|087|B|||
7332|088|D|MISSED DOSE:  It is important to get each dose of this medication||
7332|089|D|as scheduled. If you miss a dose or if your dose is interrupted||
7332|090|D|or stopped, ask your doctor right away for a new dosing schedule.||
7332|091|B|||
7332|092|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
7332|093|R|medications away from children and pets.||
7332|094|R|   Do not flush medications down the toilet or pour them into a||
7332|095|R|drain unless instructed to do so. Properly discard this product||
7332|096|R|when it is expired or no longer needed. Consult your pharmacist||
7332|097|R|or local waste disposal company.||
7332|098|B|||
7332|099|A|Information last revised January 2025.||
7332|100|A|Copyright(c) 2025 First Databank, Inc.||
7332|101|B|||
7333|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7333|002|Z|does NOT have all possible information about this product. This||
7333|003|Z|information does not assure that this product is safe, effective,||
7333|004|Z|or appropriate for you. This information is not individual||
7333|005|Z|medical advice and does not substitute for the advice of your||
7333|006|Z|health care professional. Always ask your health care||
7333|007|Z|professional for complete information about this product and your||
7333|008|Z|specific health needs.||
7333|009|B|||
7333|010|T|DEXAMETHASONE - INJECTION||
7333|011|F|(dex-uh-METH-uh-sown)||
7333|012|B|||
7333|013|C|COMMON BRAND NAME(S): Decadron Phosphate||
7333|014|B|||
7333|015|U|USES:  Dexamethasone is used to treat conditions such as||
7333|016|U|arthritis, blood/hormone disorders, allergic reactions, skin||
7333|017|U|diseases, eye problems, breathing problems, bowel disorders,||
7333|018|U|cancer, and immune system disorders. It is also used as a test||
7333|019|U|for an adrenal gland disorder (Cushing's syndrome).||
7333|020|U|   Dexamethasone belongs to a class of drugs known as||
7333|021|U|corticosteroids. It decreases your immune system's response to||
7333|022|U|various diseases to reduce symptoms such as swelling and||
7333|023|U|allergic-type reactions.||
7333|024|U|   This injectable form of dexamethasone is used when a similar||
7333|025|U|drug cannot be taken by mouth or when a very fast response is||
7333|026|U|needed, especially in patients with severe medical conditions.||
7333|027|U|Talk to your doctor about the risks and benefits of||
7333|028|U|dexamethasone, especially if it is to be injected near your spine||
7333|029|U|(epidural). Rare but serious side effects may occur with epidural||
7333|030|U|use.||
7333|031|B|||
7333|032|V|OTHER USES:  This section contains uses of this drug that are not||
7333|033|V|listed in the approved professional labeling for the drug but||
7333|034|V|that may be prescribed by your health care professional. Use this||
7333|035|V|drug for a condition that is listed in this section only if it||
7333|036|V|has been so prescribed by your health care professional.||
7333|037|V|   This drug may also be used to reduce the risk of nausea and||
7333|038|V|vomiting caused by cancer chemotherapy.||
7333|039|V|   Dexamethasone may also be used for COVID-19, but is only||
7333|040|V|effective in hospitalized patients who need supplemental oxygen||
7333|041|V|or a mechanical ventilator to breathe.||
7333|042|B|||
7333|043|H|HOW TO USE:  Depending on your product, this medication is given||
7333|044|H|by injection into a vein, muscle, joint, or skin area as directed||
7333|045|H|by your doctor. Follow your doctor's directions carefully. The||
7333|046|H|dosage is based on your medical condition and response to||
7333|047|H|treatment. Your doctor may attempt to reduce your dose slowly||
7333|048|H|from time to time to minimize side effects.||
7333|049|H|   If you are giving this medication to yourself at home, learn||
7333|050|H|all preparation and usage instructions from your health care||
7333|051|H|professional. Before using, check this product for particles or||
7333|052|H|discoloration. If either is present, do not use the liquid. Learn||
7333|053|H|how to store and discard medical supplies safely.||
7333|054|H|   Do not stop using this medication without consulting your||
7333|055|H|doctor. Some conditions may become worse when this drug is||
7333|056|H|suddenly stopped. Also, you may experience symptoms such as||
7333|057|H|nausea, dizziness, weakness, or muscle/joint pain. To prevent||
7333|058|H|these symptoms while you are stopping treatment with this drug,||
7333|059|H|your doctor may reduce your dose gradually. Consult your doctor||
7333|060|H|or pharmacist for more details. Report any new or worsening||
7333|061|H|symptoms right away.||
7333|062|H|   Tell your doctor if your condition does not get better or if||
7333|063|H|it gets worse.||
7333|064|B|||
7333|065|S|SIDE EFFECTS:  Stomach upset, heartburn, headache, trouble||
7333|066|S|sleeping, increased appetite, or pain/redness/swelling at the||
7333|067|S|injection site may occur. If any of these effects last or get||
7333|068|S|worse, tell your doctor or pharmacist promptly.||
7333|069|S|   Remember that this medication has been prescribed because your||
7333|070|S|doctor has judged that the benefit to you is greater than the||
7333|071|S|risk of side effects. Many people using this medication do not||
7333|072|S|have serious side effects.||
7333|073|S|   Tell your doctor right away if you have any serious side||
7333|074|S|effects, including: signs of infection (such as sore throat that||
7333|075|S|doesn't go away, fever, chills), bone/joint pain,||
7333|076|S|fast/slow/irregular heartbeat, eye pain/pressure, vision||
7333|077|S|problems, unusual weight gain, puffy face, swelling of the||
7333|078|S|ankles/feet, symptoms of stomach/intestinal bleeding (such as||
7333|079|S|stomach/abdominal pain, black/tarry stools, vomit that looks like||
7333|080|S|coffee grounds), mental/mood changes (such as depression, mood||
7333|081|S|swings, agitation), menstrual period changes, muscle pain/cramps,||
7333|082|S|weakness, easy bruising/bleeding, slow wound healing, thinning||
7333|083|S|skin, seizures, red/purple spots on the skin.||
7333|084|S|   This medication may rarely make your blood sugar rise, which||
7333|085|S|can cause or worsen diabetes. Tell your doctor right away if you||
7333|086|S|have symptoms of high blood sugar such as increased||
7333|087|S|thirst/urination. If you already have diabetes, check your blood||
7333|088|S|sugar regularly as directed and share the results with your||
7333|089|S|doctor. Your doctor may need to adjust your diabetes medication,||
7333|090|S|exercise program, or diet.||
7333|091|S|   A very serious allergic reaction to this drug is rare.||
7333|092|S|However, get medical help right away if you notice any symptoms||
7333|093|S|of a serious allergic reaction, including: rash, itching/swelling||
7333|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7333|095|S|breathing.||
7333|096|S|   This is not a complete list of possible side effects. If you||
7333|097|S|notice other effects not listed above, contact your doctor or||
7333|098|S|pharmacist.||
7333|099|S|   In the US -||
7333|100|S|   Call your doctor for medical advice about side effects. You||
7333|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7333|102|S|www.fda.gov/medwatch.||
7333|103|S|   In Canada - Call your doctor for medical advice about side||
7333|104|S|effects. You may report side effects to Health Canada at||
7333|105|S|1-866-234-2345.||
7333|106|B|||
7333|107|P|PRECAUTIONS:  Before using dexamethasone, tell your doctor or||
7333|108|P|pharmacist if you are allergic to it; or if you have any other||
7333|109|P|allergies. This product may contain inactive ingredients, which||
7333|110|P|can cause allergic reactions or other problems. Talk to your||
7333|111|P|pharmacist for more details.||
7333|112|P|   Before using this medication, tell your doctor or pharmacist||
7333|113|P|your medical history, especially of: infections (such as||
7333|114|P|tuberculosis, herpes, fungal infections), kidney disease, liver||
7333|115|P|disease (such as hepatitis B), mental/mood disorders (such as||
7333|116|P|psychosis, anxiety, depression), mineral imbalance (such as low||
7333|117|P|level of potassium/calcium in the blood), thyroid disease,||
7333|118|P|stomach/intestinal problems (such as ulcer, ulcerative colitis,||
7333|119|P|diverticulitis, unexplained diarrhea), high blood pressure, heart||
7333|120|P|problems (such as heart failure, recent heart attack), diabetes,||
7333|121|P|eye diseases (such as cataracts, glaucoma, herpes infection of||
7333|122|P|the eye), bone loss (osteoporosis), blood clots, a certain||
7333|123|P|adrenal gland tumor (pheochromocytoma).||
7333|124|P|   Using corticosteroid medications for a long time can make it||
7333|125|P|more difficult for your body to respond to physical stress.||
7333|126|P|Before having surgery or emergency treatment, or if you get a||
7333|127|P|serious illness/injury, tell your doctor or dentist that you are||
7333|128|P|using this medication or have used this medication within the||
7333|129|P|past 12 months. Tell your doctor right away if you develop||
7333|130|P|unusual/extreme tiredness or weight loss. If you will be using||
7333|131|P|this medication for a long time, carry a warning card or medical||
7333|132|P|ID bracelet that identifies your use of this medication.||
7333|133|P|   This medication may mask signs of infection. It can make you||
7333|134|P|more likely to get infections or may make current infections||
7333|135|P|worse. Stay away from anyone who has an infection that may easily||
7333|136|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
7333|137|P|doctor if you have been exposed to an infection or for more||
7333|138|P|details.||
7333|139|P|   This medication may cause stomach bleeding. Daily use of||
7333|140|P|alcohol while using this medication may increase your risk for||
7333|141|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
7333|142|P|or pharmacist for more information.||
7333|143|P|   Tell your health care professional that you are using||
7333|144|P|dexamethasone before having any immunizations/vaccinations. Avoid||
7333|145|P|contact with people who have recently received live vaccines||
7333|146|P|(such as flu vaccine inhaled through the nose).||
7333|147|P|   Older adults may be more sensitive to the side effects of this||
7333|148|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
7333|149|P|mental/mood changes (such as confusion).||
7333|150|P|   This medication may slow down a child's growth if used for a||
7333|151|P|long time. Consult the doctor or pharmacist for more details. See||
7333|152|P|the doctor regularly so your child's height and growth can be||
7333|153|P|checked.||
7333|154|P|   During pregnancy, this medication should be used only when||
7333|155|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
7333|156|P|risks and benefits with your doctor. Infants born to mothers who||
7333|157|P|have been using this medication for an extended time may have||
7333|158|P|hormone problems. Tell your doctor right away if you notice||
7333|159|P|symptoms such as nausea/vomiting that doesn't stop, severe||
7333|160|P|diarrhea, or weakness in your newborn.||
7333|161|P|   It is unknown if this medication passes into breast milk.||
7333|162|P|Consult your doctor before breastfeeding.||
7333|163|B|||
7333|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7333|165|I|medications work or increase your risk for serious side effects.||
7333|166|I|This document does not contain all possible drug interactions.||
7333|167|I|Keep a list of all the products you use (including||
7333|168|I|prescription/nonprescription drugs and herbal products) and share||
7333|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
7333|170|I|the dosage of any medicines without your doctor's approval.||
7333|171|I|   Some products that may interact with this drug include:||
7333|172|I|aldesleukin, desmopressin, drugs that can cause bleeding/bruising||
7333|173|I|(including antiplatelet drugs such as clopidogrel, "blood||
7333|174|I|thinners" such as dabigatran/warfarin, NSAIDs such as||
7333|175|I|aspirin/celecoxib/ibuprofen), mifepristone.||
7333|176|I|   This medication can speed up the removal of other medications||
7333|177|I|from your body, which may affect how they work. Examples of||
7333|178|I|affected drugs include certain cancer drugs (such as dasatinib,||
7333|179|I|lapatinib, sunitinib), praziquantel, rilpivirine, among others.||
7333|180|I|   If your doctor has told you to take low-dose aspirin to||
7333|181|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
7333|182|I|you should keep taking the aspirin unless your doctor tells you||
7333|183|I|not to. Ask your doctor or pharmacist for more details.||
7333|184|I|   This medication may interfere with certain lab tests||
7333|185|I|(including skin tests), possibly causing false test results. Make||
7333|186|I|sure lab personnel and all your doctors know you use this drug.||
7333|187|B|||
7333|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7333|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7333|190|O|poison control center right away. US residents can call||
7333|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7333|192|B|||
7333|193|N|NOTES:  Do not share this medication with others.||
7333|194|N|   If this medication is used for a long time, lab and/or medical||
7333|195|N|tests (such as blood mineral levels, blood glucose, complete||
7333|196|N|blood count, bone density tests, blood pressure, eye exams)||
7333|197|N|should be done while you are using this medication. Keep all||
7333|198|N|medical and lab appointments. Consult your doctor for more||
7333|199|N|details.||
7333|200|N|   This medication may cause bone loss (osteoporosis) when used||
7333|201|N|for a long time. Lifestyle changes that may help reduce the risk||
7333|202|N|of bone problems include doing weight-bearing exercise, stopping||
7333|203|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
7333|204|N|D. Talk to your doctor for more details.||
7333|205|B|||
7333|206|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7333|207|D|If it is near the time of the next dose, skip the missed dose.||
7333|208|D|Use your next dose at the regular time. Do not double the dose to||
7333|209|D|catch up.||
7333|210|B|||
7333|211|R|STORAGE:  Consult the product instructions and your pharmacist||
7333|212|R|for storage details. Keep all medications away from children and||
7333|213|R|pets.||
7333|214|R|   Do not flush medications down the toilet or pour them into a||
7333|215|R|drain unless instructed to do so. Properly discard this product||
7333|216|R|when it is expired or no longer needed. Consult your pharmacist||
7333|217|R|or local waste disposal company.||
7333|218|B|||
7333|219|M|MEDICAL ALERT:  Your condition can cause complications in a||
7333|220|M|medical emergency. For information about enrolling in MedicAlert,||
7333|221|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7333|222|B|||
7333|223|A|Information last revised September 2025.||
7333|224|A|Copyright(c) 2025 First Databank, Inc.||
7333|225|B|||
7341|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7341|002|Z|does NOT have all possible information about this product. This||
7341|003|Z|information does not assure that this product is safe, effective,||
7341|004|Z|or appropriate for you. This information is not individual||
7341|005|Z|medical advice and does not substitute for the advice of your||
7341|006|Z|health care professional. Always ask your health care||
7341|007|Z|professional for complete information about this product and your||
7341|008|Z|specific health needs.||
7341|009|B|||
7341|010|T|GEMTUZUMAB OZOGAMICIN - INJECTION||
7341|011|F|(jem-TOOZ-ue-mab OH-zoe-ga-MYE-sin)||
7341|012|B|||
7341|013|C|COMMON BRAND NAME(S): Mylotarg||
7341|014|B|||
7341|015|W|WARNING:  This medication may cause very serious (even fatal)||
7341|016|W|liver damage, including a certain type known as veno-occlusive||
7341|017|W|disease (VOD). The risk is increased with higher doses, or if you||
7341|018|W|already have liver problems, or if you have had a bone marrow||
7341|019|W|transplant. Careful monitoring by your doctor may decrease your||
7341|020|W|risk. Tell your doctor right away if you develop nausea/vomiting||
7341|021|W|that doesn't stop, loss of appetite, stomach/abdominal pain,||
7341|022|W|yellowing eyes/skin, dark urine, swelling abdomen, sudden weight||
7341|023|W|gain. Your doctor may change your dosage schedule or stop||
7341|024|W|treatment with this medication if you develop VOD.||
7341|025|B|||
7341|026|U|USES:  This medication is used to treat a certain type of||
7341|027|U|leukemia (CD33-positive acute myeloid leukemia-AML). This||
7341|028|U|medication works by slowing or stopping the growth of cancer||
7341|029|U|cells.||
7341|030|B|||
7341|031|H|HOW TO USE:  This medication is given by slow injection into a||
7341|032|H|vein as directed by your doctor, usually over 2 hours. The dosage||
7341|033|H|and treatment schedule are based on your medical condition,||
7341|034|H|response to treatment, and body size.||
7341|035|H|   Infusion reactions may happen during the infusion of this drug||
7341|036|H|and for up to 24 hours afterward. Your doctor may prescribe other||
7341|037|H|medications (such as acetaminophen, diphenhydramine) before each||
7341|038|H|treatment to help prevent these side effects. Tell your doctor||
7341|039|H|right away if you have any symptoms of infusion reactions such as||
7341|040|H|chills, fever, fast heartbeat, shortness of breath, or dizziness.||
7341|041|H|Your doctor may give you other medications to help with these||
7341|042|H|side effects or may slow down or stop your treatment for some||
7341|043|H|time.||
7341|044|H|   To get the most benefit from this medication, do not miss any||
7341|045|H|doses. To help you remember, mark your calendar with a reminder.||
7341|046|B|||
7341|047|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
7341|048|S|   Nausea, vomiting, constipation, or headache may occur. Pain or||
7341|049|S|sores in the mouth and throat may occur. Brush your teeth||
7341|050|S|carefully/gently, avoid using mouthwash that contains alcohol,||
7341|051|S|and rinse your mouth often with cool water mixed with baking soda||
7341|052|S|or salt. It may also be best to eat soft, moist foods. If any of||
7341|053|S|these effects last or get worse, tell your doctor or pharmacist||
7341|054|S|promptly.||
7341|055|S|   People using this medication may have serious side effects.||
7341|056|S|However, you have been prescribed this drug because your doctor||
7341|057|S|has judged that the benefit to you is greater than the risk of||
7341|058|S|side effects. Careful monitoring by your doctor may decrease your||
7341|059|S|risk.||
7341|060|S|   This medication may lower your ability to fight infections.||
7341|061|S|This may make you more likely to get a serious (rarely fatal)||
7341|062|S|infection or make any infection you have worse. Tell your doctor||
7341|063|S|right away if you have any signs of infection (such as sore||
7341|064|S|throat that doesn't go away, fever, chills).||
7341|065|S|   Tell your doctor right away if you have any serious side||
7341|066|S|effects, including: easy bruising/bleeding.||
7341|067|S|   Get medical help right away if you have any very serious side||
7341|068|S|effects, including: fast/irregular heartbeat, severe dizziness,||
7341|069|S|signs of bleeding (such as pink/bloody urine, dark/tarry stools,||
7341|070|S|vomit that looks like coffee grounds), symptoms of bleeding in||
7341|071|S|the brain (such as dizziness/fainting, sudden vision changes,||
7341|072|S|nausea, seizures, confusion).||
7341|073|S|   A very serious allergic reaction to this drug is rare.||
7341|074|S|However, get medical help right away if you notice any symptoms||
7341|075|S|of a serious allergic reaction, including: rash, itching/swelling||
7341|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7341|077|S|breathing.||
7341|078|S|   This is not a complete list of possible side effects. If you||
7341|079|S|notice other effects not listed above, contact your doctor or||
7341|080|S|pharmacist.||
7341|081|S|   In the US -||
7341|082|S|   Call your doctor for medical advice about side effects. You||
7341|083|S|may report side effects to FDA at 1-800-FDA-1088.||
7341|084|S|   In Canada - Call your doctor for medical advice about side||
7341|085|S|effects. You may report side effects to Health Canada at||
7341|086|S|1-866-234-2345.||
7341|087|B|||
7341|088|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
7341|089|P|pharmacist if you are allergic to it; or if you have any other||
7341|090|P|allergies. This product may contain inactive ingredients, which||
7341|091|P|can cause allergic reactions or other problems. Talk to your||
7341|092|P|pharmacist for more details.||
7341|093|P|   Before using this medication, tell your doctor or pharmacist||
7341|094|P|your medical history, especially of: other blood/bone marrow||
7341|095|P|disorders (such as increased white blood cell count), bone marrow||
7341|096|P|transplant, liver disease, recent/current infection.||
7341|097|P|   This medication can make you more likely to get infections or||
7341|098|P|may make current infections worse. Stay away from anyone who has||
7341|099|P|an infection that may easily spread (such as chickenpox,||
7341|100|P|COVID-19, measles, flu). Talk to your doctor if you have been||
7341|101|P|exposed to an infection or for more details.||
7341|102|P|   Tell your health care professional that you are using||
7341|103|P|gemtuzumab ozogamicin before having any||
7341|104|P|immunizations/vaccinations. Avoid contact with people who have||
7341|105|P|recently received live vaccines (such as flu vaccine inhaled||
7341|106|P|through the nose).||
7341|107|P|   To lower the chance of getting cut, bruised, or injured, use||
7341|108|P|caution with sharp objects like razors and nail cutters, and||
7341|109|P|avoid activities such as contact sports.||
7341|110|P|   This medication may cause a condition that affects the heart||
7341|111|P|rhythm (QT prolongation). QT prolongation can rarely cause||
7341|112|P|serious (rarely fatal) fast/irregular heartbeat and other||
7341|113|P|symptoms (such as severe dizziness, fainting) that need medical||
7341|114|P|attention right away.||
7341|115|P|   The risk of QT prolongation may be increased if you have||
7341|116|P|certain medical conditions or are taking other drugs that may||
7341|117|P|cause QT prolongation. Before using gemtuzumab ozogamicin, tell||
7341|118|P|your doctor or pharmacist of all the drugs you take and if you||
7341|119|P|have any of the following conditions: certain heart problems||
7341|120|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
7341|121|P|family history of certain heart problems (QT prolongation in the||
7341|122|P|EKG, sudden cardiac death).||
7341|123|P|   Low levels of potassium or magnesium in the blood may also||
7341|124|P|increase your risk of QT prolongation. This risk may increase if||
7341|125|P|you use certain drugs (such as diuretics/"water pills") or if you||
7341|126|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7341|127|P|Talk to your doctor about using this medication safely.||
7341|128|P|   Before having surgery, tell your doctor or dentist about all||
7341|129|P|the products you use (including prescription drugs,||
7341|130|P|nonprescription drugs, and herbal products).||
7341|131|P|   Older adults may be more sensitive to the side effects of this||
7341|132|P|drug, especially QT prolongation (see above).||
7341|133|P|   Tell your doctor if you are pregnant or plan to become||
7341|134|P|pregnant. You should not become pregnant while using this||
7341|135|P|medication. Gemtuzumab ozogamicin may harm an unborn baby. Women||
7341|136|P|using this medication should ask about reliable forms of birth||
7341|137|P|control during treatment and for at least 6 months after the last||
7341|138|P|dose. Men using this medication should ask about reliable forms||
7341|139|P|of birth control during treatment and for at least 3 months after||
7341|140|P|the last dose. If you or your partner becomes pregnant, talk to||
7341|141|P|your doctor right away about the risks and benefits of this||
7341|142|P|medication.||
7341|143|P|   It is unknown if this drug passes into breast milk. Because of||
7341|144|P|the possible risk to the infant, breastfeeding is not recommended||
7341|145|P|while using this drug and for at least 1 month after the last||
7341|146|P|dose. Consult your doctor before breastfeeding.||
7341|147|B|||
7341|148|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7341|149|I|medications work or increase your risk for serious side effects.||
7341|150|I|This document does not contain all possible drug interactions.||
7341|151|I|Keep a list of all the products you use (including||
7341|152|I|prescription/nonprescription drugs and herbal products) and share||
7341|153|I|it with your doctor and pharmacist. Do not start, stop, or change||
7341|154|I|the dosage of any medicines without your doctor's approval.||
7341|155|B|||
7341|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7341|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7341|158|O|poison control center right away. US residents can call||
7341|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7341|160|B|||
7341|161|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
7341|162|N|liver function) should be done while you are using this||
7341|163|N|medication. Keep all medical and lab appointments.||
7341|164|B|||
7341|165|D|MISSED DOSE:  It is important to get each dose of this medication||
7341|166|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
7341|167|D|right away for a new dosing schedule.||
7341|168|B|||
7341|169|R|STORAGE:  Not applicable. This medication is given in a hospital||
7341|170|R|or clinic and will not be stored at home.||
7341|171|B|||
7341|172|M|MEDICAL ALERT:  Your condition can cause complications in a||
7341|173|M|medical emergency. For information about enrolling in MedicAlert,||
7341|174|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
7341|175|B|||
7341|176|A|Information last revised May 2025.||
7341|177|A|Copyright(c) 2025 First Databank, Inc.||
7341|178|B|||
7352|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7352|002|Z|does NOT have all possible information about this product. This||
7352|003|Z|information does not assure that this product is safe, effective,||
7352|004|Z|or appropriate for you. This information is not individual||
7352|005|Z|medical advice and does not substitute for the advice of your||
7352|006|Z|health care professional. Always ask your health care||
7352|007|Z|professional for complete information about this product and your||
7352|008|Z|specific health needs.||
7352|009|B|||
7352|010|T|BUPRENORPHINE - SUBLINGUAL||
7352|011|F|(BUE-pre-NOR-feen)||
7352|012|B|||
7352|013|C|COMMON BRAND NAME(S): Subutex||
7352|014|B|||
7352|015|U|USES:  Buprenorphine is used to treat opioid use disorder.||
7352|016|U|Buprenorphine belongs to a class of drugs called mixed opioid||
7352|017|U|agonist-antagonists. It helps prevent withdrawal symptoms caused||
7352|018|U|by stopping other opioids. It is used as part of a complete||
7352|019|U|treatment program for opioid use disorder (such as compliance||
7352|020|U|monitoring, counseling, behavioral contract, lifestyle changes).||
7352|021|U|   Ask your doctor or pharmacist if you should have medication||
7352|022|U|available to treat opioid overdose (such as naloxone, nalmefene).||
7352|023|U|Teach your family or household members about the signs of an||
7352|024|U|opioid overdose and how to treat it.||
7352|025|B|||
7352|026|H|HOW TO USE:  Read the Medication Guide provided by your||
7352|027|H|pharmacist before you start using sublingual buprenorphine and||
7352|028|H|each time you get a refill. If you have any questions, ask your||
7352|029|H|doctor or pharmacist.||
7352|030|H|   Use this medication as directed by your doctor, usually once||
7352|031|H|daily. Place the medication under your tongue for 5 to 10 minutes||
7352|032|H|and let it dissolve completely. If you are prescribed more than||
7352|033|H|one tablet each day, you may place all of the tablets under your||
7352|034|H|tongue at once or place two tablets at a time under your tongue.||
7352|035|H|Do not swallow or chew this medication. It will not work as well.||
7352|036|H|   After the medication is fully dissolved, take a large sip of||
7352|037|H|water and swish gently around your teeth and gums, and then||
7352|038|H|swallow the water. This will help to prevent problems with your||
7352|039|H|teeth. Do not brush your teeth for at least one hour after using||
7352|040|H|this medication.||
7352|041|H|   Buprenorphine alone is usually used for the first 2 days after||
7352|042|H|you have stopped all other opioids. It is usually given in your||
7352|043|H|doctor's office. Your doctor will then switch you to the||
7352|044|H|combination buprenorphine/naloxone medication for maintenance||
7352|045|H|treatment. The combination with naloxone works the same way as||
7352|046|H|buprenorphine alone to prevent withdrawal symptoms. It is||
7352|047|H|combined with naloxone to prevent misuse (injection) of the||
7352|048|H|medication.||
7352|049|H|   Buprenorphine works best when the first dose is started after||
7352|050|H|signs of opioid withdrawal have begun. Buprenorphine can cause||
7352|051|H|withdrawal symptoms if started too soon after your last opioid||
7352|052|H|use. Follow your doctor's instructions for your treatment plan.||
7352|053|H|   The dosage is based on your medical condition and response to||
7352|054|H|treatment. Do not increase your dose, take the medication more||
7352|055|H|often, or take it for a longer time than prescribed. Properly||
7352|056|H|stop the medication when so directed.||
7352|057|H|   Use this medication regularly in order to get the most benefit||
7352|058|H|from it. To help you remember, use it at the same time each day.||
7352|059|H|   Suddenly stopping this medication may cause withdrawal,||
7352|060|H|especially if you have used it for a long time or in high doses.||
7352|061|H|To prevent withdrawal, your doctor may lower your dose slowly.||
7352|062|H|Tell your doctor or pharmacist right away if you have any||
7352|063|H|withdrawal symptoms such as restlessness, mental/mood changes||
7352|064|H|(including anxiety, trouble sleeping, thoughts of suicide),||
7352|065|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
7352|066|H|aches, or sudden changes in behavior.||
7352|067|H|   Do not inject ("shoot up") buprenorphine. Injecting it is||
7352|068|H|dangerous and may cause severe withdrawal symptoms (see Side||
7352|069|H|Effects section). Consult your doctor or pharmacist for more||
7352|070|H|details.||
7352|071|H|   Tell your doctor right away if your condition does not get||
7352|072|H|better or if it gets worse.||
7352|073|B|||
7352|074|S|SIDE EFFECTS:  Drowsiness, dizziness, constipation, or headache||
7352|075|S|may occur. If any of these effects last or get worse, tell your||
7352|076|S|doctor or pharmacist right away.||
7352|077|S|   To prevent constipation, eat dietary fiber, drink enough||
7352|078|S|water, and exercise. You may also need to take a laxative. Ask||
7352|079|S|your pharmacist which type of laxative is right for you.||
7352|080|S|   To reduce the risk of dizziness and lightheadedness, get up||
7352|081|S|slowly when rising from a sitting or lying position.||
7352|082|S|   Remember that this medication has been prescribed because your||
7352|083|S|doctor has judged that the benefit to you is greater than the||
7352|084|S|risk of side effects. Many people using this medication do not||
7352|085|S|have serious side effects.||
7352|086|S|   Severe (possibly fatal) breathing problems can occur if this||
7352|087|S|medication is abused, injected, or mixed with other depressants||
7352|088|S|(such as alcohol, benzodiazepines including diazepam, other||
7352|089|S|opioids).||
7352|090|S|   Tell your doctor right away if you have any serious side||
7352|091|S|effects, including: interrupted breathing during sleep (sleep||
7352|092|S|apnea), mental/mood changes (such as agitation, confusion,||
7352|093|S|hallucinations), stomach/abdominal pain, tooth/gum pain, signs of||
7352|094|S|your adrenal glands not working well (such as unusual tiredness,||
7352|095|S|weight loss), trouble swallowing.||
7352|096|S|   Get medical help right away if you have any very serious side||
7352|097|S|effects, including: fainting, fast/irregular heartbeat, severe||
7352|098|S|dizziness, slow/shallow breathing, unusual drowsiness/difficulty||
7352|099|S|waking up.||
7352|100|S|   Although this medication is used to prevent withdrawal||
7352|101|S|reactions, it may rarely cause opioid withdrawal symptoms,||
7352|102|S|including diarrhea, severe mental/mood changes (such as anxiety,||
7352|103|S|irritability, trouble sleeping), muscle stiffness or shakiness.||
7352|104|S|This is more likely when you first start treatment or if you have||
7352|105|S|been using long-acting opioids such as methadone. If such||
7352|106|S|symptoms occur, notify your doctor or pharmacist right away.||
7352|107|S|   This drug may rarely cause serious liver disease. Get medical||
7352|108|S|help right away if you have any symptoms of liver damage,||
7352|109|S|including: nausea/vomiting that doesn't stop, dark urine, loss of||
7352|110|S|appetite, yellowing eyes/skin, severe stomach/abdominal pain.||
7352|111|S|   A very serious allergic reaction to this drug is rare.||
7352|112|S|However, get medical help right away if you notice any symptoms||
7352|113|S|of a serious allergic reaction, including: rash, itching/swelling||
7352|114|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7352|115|S|breathing.||
7352|116|S|   This is not a complete list of possible side effects. If you||
7352|117|S|notice other effects not listed above, contact your doctor or||
7352|118|S|pharmacist.||
7352|119|S|   In the US -||
7352|120|S|   Call your doctor for medical advice about side effects. You||
7352|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7352|122|S|www.fda.gov/medwatch.||
7352|123|S|   In Canada - Call your doctor for medical advice about side||
7352|124|S|effects. You may report side effects to Health Canada at||
7352|125|S|1-866-234-2345.||
7352|126|B|||
7352|127|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
7352|128|P|pharmacist if you are allergic to it; or if you have any other||
7352|129|P|allergies. This product may contain inactive ingredients, which||
7352|130|P|can cause allergic reactions or other problems. Talk to your||
7352|131|P|pharmacist for more details.||
7352|132|P|   Before using this medication, tell your doctor or pharmacist||
7352|133|P|your medical history, especially of: brain disorders (such as||
7352|134|P|head injury, tumor, seizures), breathing problems (such as||
7352|135|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
7352|136|P|liver disease, mental/mood disorders (such as confusion,||
7352|137|P|depression), stomach/intestinal problems (such as blockage,||
7352|138|P|constipation, diarrhea due to infection, paralytic ileus),||
7352|139|P|difficulty urinating (such as due to enlarged prostate).||
7352|140|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
7352|141|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
7352|142|P|machinery, or do anything that needs alertness until you can do||
7352|143|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
7352|144|P|are using marijuana (cannabis). Alcohol also increases your risk||
7352|145|P|for breathing problems.||
7352|146|P|   Buprenorphine may cause a condition that affects the heart||
7352|147|P|rhythm (QT prolongation). QT prolongation can rarely cause||
7352|148|P|serious (rarely fatal) fast/irregular heartbeat and other||
7352|149|P|symptoms (such as severe dizziness, fainting) that need medical||
7352|150|P|attention right away.||
7352|151|P|   The risk of QT prolongation may be increased if you have||
7352|152|P|certain medical conditions or are taking other drugs that may||
7352|153|P|cause QT prolongation. Before using buprenorphine, tell your||
7352|154|P|doctor or pharmacist of all the drugs you take and if you have||
7352|155|P|any of the following conditions: certain heart problems (heart||
7352|156|P|failure, slow heartbeat, QT prolongation in the EKG), family||
7352|157|P|history of certain heart problems (QT prolongation in the EKG,||
7352|158|P|sudden cardiac death).||
7352|159|P|   Low levels of potassium or magnesium in the blood may also||
7352|160|P|increase your risk of QT prolongation. This risk may increase if||
7352|161|P|you use certain drugs (such as diuretics/"water pills") or if you||
7352|162|P|have conditions such as severe sweating, diarrhea, or vomiting.||
7352|163|P|Talk to your doctor about using buprenorphine safely.||
7352|164|P|   Some people using this medication may have dental problems||
7352|165|P|(such as tooth decay/loss, cavities, infection). Schedule a visit||
7352|166|P|to the dentist soon after starting this medication and tell your||
7352|167|P|dentist that you are using this medication. To help prevent||
7352|168|P|dental problems, have regular dental exams and learn how to keep||
7352|169|P|your teeth and gums healthy. If you have tooth or gum pain, tell||
7352|170|P|your doctor and dentist right away.||
7352|171|P|   Before having surgery, tell your doctor or dentist about all||
7352|172|P|the products you use (including prescription drugs,||
7352|173|P|nonprescription drugs, and herbal products).||
7352|174|P|   Older adults may be more sensitive to the side effects of this||
7352|175|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
7352|176|P|breathing, and QT prolongation (see above).||
7352|177|P|   Before using this medication, women of childbearing age should||
7352|178|P|talk with their doctor(s) about the risks and benefits. Tell your||
7352|179|P|doctor if you are pregnant or if you plan to become pregnant.||
7352|180|P|During pregnancy, this medication should be used only when||
7352|181|P|clearly needed. It may slightly increase the risk of birth||
7352|182|P|defects if used during the first two months of pregnancy. Also,||
7352|183|P|using it for a long time or in high doses near the expected||
7352|184|P|delivery date may harm the unborn baby. To lessen the risk, take||
7352|185|P|the smallest effective dose for the shortest possible time. Tell||
7352|186|P|the doctor right away if you notice any symptoms in your newborn||
7352|187|P|baby such as crying that is unusual or doesn't stop, slow/shallow||
7352|188|P|breathing, irritability, vomiting, or diarrhea.||
7352|189|P|   This drug passes into breast milk and may rarely have||
7352|190|P|undesirable effects on a nursing infant. Tell the doctor right||
7352|191|P|away if your baby develops unusual sleepiness, difficulty||
7352|192|P|feeding, or trouble breathing. Consult your doctor before||
7352|193|P|breastfeeding.||
7352|194|B|||
7352|195|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7352|196|I|medications work or increase your risk for serious side effects.||
7352|197|I|This document does not contain all possible drug interactions.||
7352|198|I|Keep a list of all the products you use (including||
7352|199|I|prescription/nonprescription drugs and herbal products) and share||
7352|200|I|it with your doctor and pharmacist. Do not start, stop, or change||
7352|201|I|the dosage of any medicines without your doctor's approval.||
7352|202|I|   Some products that may interact with this drug include:||
7352|203|I|certain pain medications (mixed opioid agonist-antagonists such||
7352|204|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
7352|205|I|samidorphan.||
7352|206|I|   The risk of serious side effects (such as slow/shallow||
7352|207|I|breathing, severe drowsiness/dizziness) may be increased if this||
7352|208|I|medication is used with other products that may also affect||
7352|209|I|breathing or cause drowsiness. Tell your doctor or pharmacist if||
7352|210|I|you are taking other products such as alcohol, marijuana||
7352|211|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
7352|212|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
7352|213|I|zolpidem), muscle relaxants (such as carisoprodol,||
7352|214|I|cyclobenzaprine), and other opioid pain relievers (such as||
7352|215|I|codeine, hydrocodone).||
7352|216|I|   Check the labels on all your medicines (such as allergy or||
7352|217|I|cough-and-cold products) because they may contain ingredients||
7352|218|I|that cause drowsiness. Ask your pharmacist about using those||
7352|219|I|products safely.||
7352|220|I|   Deaths have occurred when buprenorphine has been misused by||
7352|221|I|injecting it ("shooting up"), especially when used in combination||
7352|222|I|with benzodiazepines (such as diazepam) or other depressants such||
7352|223|I|as alcohol or additional opioids.||
7352|224|B|||
7352|225|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7352|226|O|as passing out or trouble breathing, give them naloxone if||
7352|227|O|available, then call 911. If the person is awake and has no||
7352|228|O|symptoms, call a poison control center right away. US residents||
7352|229|O|can call 1-800-222-1222. Canada residents can call||
7352|230|O|1-844-764-7669. Symptoms of overdose may include: slow breathing,||
7352|231|O|slow heartbeat, loss of consciousness.||
7352|232|B|||
7352|233|N|NOTES:  Do not share this medication with others. Sharing it is||
7352|234|N|against the law.||
7352|235|N|   Tell all of your doctors that you use this medication and have||
7352|236|N|regularly used opioids, especially in cases of emergency||
7352|237|N|treatment.||
7352|238|N|   Lab and/or medical tests (such as liver function) should be||
7352|239|N|done while you are taking this medication. Keep all medical and||
7352|240|N|lab appointments. Consult your doctor for more details.||
7352|241|B|||
7352|242|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7352|243|D|remember. If it is near the time of the next dose, skip the||
7352|244|D|missed dose. Take your next dose at the regular time. Do not||
7352|245|D|double the dose to catch up.||
7352|246|B|||
7352|247|R|STORAGE:  Store at room temperature away from light and moisture.||
7352|248|R|Do not store in the bathroom. Keep all medications away from||
7352|249|R|children and pets.||
7352|250|R|   Do not flush medications down the toilet or pour them into a||
7352|251|R|drain unless instructed to do so. Properly discard this product||
7352|252|R|when it is expired or no longer needed. For more details, read||
7352|253|R|the Medication Guide, or consult your pharmacist or local waste||
7352|254|R|disposal company.||
7352|255|B|||
7352|256|A|Information last revised August 2025.||
7352|257|A|Copyright(c) 2025 First Databank, Inc.||
7352|258|B|||
7367|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7367|002|Z|does NOT have all possible information about this product. This||
7367|003|Z|information does not assure that this product is safe, effective,||
7367|004|Z|or appropriate for you. This information is not individual||
7367|005|Z|medical advice and does not substitute for the advice of your||
7367|006|Z|health care professional. Always ask your health care||
7367|007|Z|professional for complete information about this product and your||
7367|008|Z|specific health needs.||
7367|009|B|||
7367|010|T|CHLORDIAZEPOXIDE - ORAL||
7367|011|F|(KLOR-dye-AZ-e-POX-ide)||
7367|012|B|||
7367|013|C|COMMON BRAND NAME(S): Librium||
7367|014|B|||
7367|015|W|WARNING:  Chlordiazepoxide has a risk for abuse and addiction,||
7367|016|W|which can lead to overdose and death. Taking this medication with||
7367|017|W|alcohol or other drugs that can cause drowsiness or breathing||
7367|018|W|problems (especially opioid medications such as codeine,||
7367|019|W|hydrocodone) may cause very serious side effects, including||
7367|020|W|death. To lower your risk, your doctor should have you take the||
7367|021|W|smallest dose of chlordiazepoxide that works, and take it for the||
7367|022|W|shortest possible time. Be sure you know how to take||
7367|023|W|chlordiazepoxide and what other drugs you should avoid taking||
7367|024|W|with it. See also Drug Interactions section. Get medical help||
7367|025|W|right away if any of these very serious side effects occur:||
7367|026|W|slow/shallow breathing, unusual lightheadedness, severe||
7367|027|W|drowsiness/dizziness, difficulty waking up.||
7367|028|W|   Suddenly stopping this medication may cause serious (possibly||
7367|029|W|fatal) withdrawal, especially if you have used it for a long time||
7367|030|W|or in high doses. To prevent withdrawal, your doctor may lower||
7367|031|W|your dose slowly. Tell your doctor or pharmacist right away if||
7367|032|W|you have any withdrawal symptoms such as headaches, trouble||
7367|033|W|sleeping, restlessness, hallucinations/confusion, depression,||
7367|034|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
7367|035|W|to months.||
7367|036|B|||
7367|037|U|USES:  Chlordiazepoxide is used to treat anxiety and acute||
7367|038|U|alcohol withdrawal. It is also used to relieve fear and anxiety||
7367|039|U|before surgery. This medication belongs to a class of drugs||
7367|040|U|called benzodiazepines which act on the brain and nerves (central||
7367|041|U|nervous system) to produce a calming effect. It works by||
7367|042|U|enhancing the effects of a certain natural chemical in the body||
7367|043|U|(GABA).||
7367|044|B|||
7367|045|H|HOW TO USE:  See also Warning section.||
7367|046|H|   Read the Medication Guide provided by your pharmacist before||
7367|047|H|you start taking chlordiazepoxide and each time you get a refill.||
7367|048|H|If you have any questions, ask your doctor or pharmacist.||
7367|049|H|   Take this medication by mouth as directed by your doctor. The||
7367|050|H|dosage is based on your age, medical condition, and response to||
7367|051|H|treatment.||
7367|052|H|   When this medication is used for a long time, it may not work||
7367|053|H|as well. Talk with your doctor if this medication stops working||
7367|054|H|well.||
7367|055|H|   Though it helps many people, this medication may sometimes||
7367|056|H|cause addiction. This risk may be higher if you have a substance||
7367|057|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
7367|058|H|Take this medication exactly as prescribed to lower the risk of||
7367|059|H|addiction. Ask your doctor or pharmacist for more details.||
7367|060|B|||
7367|061|S|SIDE EFFECTS:  See also Warning section.||
7367|062|S|   Drowsiness, dizziness, nausea, constipation, blurred vision,||
7367|063|S|or headache may occur. If any of these effects last or get worse,||
7367|064|S|tell your doctor or pharmacist promptly.||
7367|065|S|   Remember that this medication has been prescribed because your||
7367|066|S|doctor has judged that the benefit to you is greater than the||
7367|067|S|risk of side effects. Many people using this medication do not||
7367|068|S|have serious side effects.||
7367|069|S|   Tell your doctor right away if you have any serious side||
7367|070|S|effects, including: mental/mood changes, trouble speaking,||
7367|071|S|clumsiness, trouble walking, decreased/increased interest in sex,||
7367|072|S|tremor, uncontrollable movements, facial or muscle twitching,||
7367|073|S|trouble urinating, sleep disturbances, fainting, unusual||
7367|074|S|tiredness, signs of liver disease (such as nausea/vomiting that||
7367|075|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
7367|076|S|eyes/skin, dark urine), signs of infection (such as sore throat||
7367|077|S|that doesn't go away, fever, chills).||
7367|078|S|   A very serious allergic reaction to this drug is rare.||
7367|079|S|However, get medical help right away if you notice any symptoms||
7367|080|S|of a serious allergic reaction, including: rash, itching/swelling||
7367|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7367|082|S|breathing.||
7367|083|S|   This is not a complete list of possible side effects. If you||
7367|084|S|notice other effects not listed above, contact your doctor or||
7367|085|S|pharmacist.||
7367|086|S|   In the US -||
7367|087|S|   Call your doctor for medical advice about side effects. You||
7367|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7367|089|S|www.fda.gov/medwatch.||
7367|090|S|   In Canada - Call your doctor for medical advice about side||
7367|091|S|effects. You may report side effects to Health Canada at||
7367|092|S|1-866-234-2345.||
7367|093|B|||
7367|094|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
7367|095|P|pharmacist if you are allergic to it; or to other benzodiazepines||
7367|096|P|(such as diazepam, lorazepam); or if you have any other||
7367|097|P|allergies. This product may contain inactive ingredients, which||
7367|098|P|can cause allergic reactions or other problems. Talk to your||
7367|099|P|pharmacist for more details.||
7367|100|P|   Before using this medication, tell your doctor or pharmacist||
7367|101|P|your medical history, especially of: liver disease, kidney||
7367|102|P|disease, lung/breathing problems (such as COPD, sleep apnea),||
7367|103|P|blood disorder (porphyria), drug or alcohol abuse.||
7367|104|P|   This drug may make you dizzy or drowsy or blur your vision.||
7367|105|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
7367|106|P|drowsy. Do not drive, use machinery, or do anything that needs||
7367|107|P|alertness or clear vision until you can do it safely. Avoid||
7367|108|P|alcoholic beverages. Talk to your doctor if you are using||
7367|109|P|marijuana (cannabis).||
7367|110|P|   Older adults may be more sensitive to the side effects of this||
7367|111|P|drug, especially drowsiness. Drowsiness can increase the risk of||
7367|112|P|falling.||
7367|113|P|   Tell your doctor if you are pregnant or plan to become||
7367|114|P|pregnant. You should not become pregnant while using||
7367|115|P|chlordiazepoxide. Chlordiazepoxide may harm an unborn baby.||
7367|116|P|Newborn babies of mothers who use this medication late in||
7367|117|P|pregnancy may have symptoms such as slow/shallow breathing,||
7367|118|P|nonstop crying, shaking, or trouble feeding. If you become||
7367|119|P|pregnant, talk to your doctor right away about the risks and||
7367|120|P|benefits of this medication.||
7367|121|P|   Based on information from related drugs, this drug may pass||
7367|122|P|into breast milk and may have undesirable effects on a nursing||
7367|123|P|infant. Consult your doctor before breastfeeding.||
7367|124|B|||
7367|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7367|126|I|medications work or increase your risk for serious side effects.||
7367|127|I|This document does not contain all possible drug interactions.||
7367|128|I|Keep a list of all the products you use (including||
7367|129|I|prescription/nonprescription drugs and herbal products) and share||
7367|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
7367|131|I|the dosage of any medicines without your doctor's approval.||
7367|132|I|   Some products that may interact with this drug include:||
7367|133|I|antacids, certain anti-depressants (such as fluoxetine,||
7367|134|I|fluvoxamine, nefazodone), cimetidine, clozapine, digoxin,||
7367|135|I|disulfiram, kava, sodium oxybate.||
7367|136|I|   The risk of serious side effects (such as slow/shallow||
7367|137|I|breathing, severe drowsiness/dizziness) may be increased if this||
7367|138|I|medication is taken with other products that may also cause||
7367|139|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
7367|140|I|if you are taking other products such as opioid pain or cough||
7367|141|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
7367|142|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
7367|143|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
7367|144|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
7367|145|I|diphenhydramine).||
7367|146|I|   Check the labels on all your medicines (such as allergy or||
7367|147|I|cough-and-cold products) because they may contain ingredients||
7367|148|I|that cause drowsiness. Ask your pharmacist about using those||
7367|149|I|products safely.||
7367|150|I|   This medication may interfere with certain lab tests, possibly||
7367|151|I|causing false test results. Make sure lab personnel and all your||
7367|152|I|doctors know you use this drug.||
7367|153|I|   Smoking can decrease the effectiveness of this drug (through||
7367|154|I|liver enzyme induction). Tell your doctor if you smoke or if you||
7367|155|I|have recently stopped smoking because your dose may need to be||
7367|156|I|adjusted.||
7367|157|B|||
7367|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7367|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7367|160|O|poison control center right away. US residents can call||
7367|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7367|162|O|Symptoms of overdose may include: severe drowsiness,||
7367|163|O|slowed/reduced reflexes, slowed breathing, fainting, loss of||
7367|164|O|consciousness.||
7367|165|B|||
7367|166|N|NOTES:  Do not share this medication with others. Sharing it is||
7367|167|N|against the law.||
7367|168|N|   If this drug is used for an extended period of time, lab||
7367|169|N|and/or medical tests (such as liver function, complete blood||
7367|170|N|count) may be done while you are taking this medication. Keep all||
7367|171|N|medical and lab appointments. Consult your doctor for more||
7367|172|N|details.||
7367|173|B|||
7367|174|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
7367|175|D|If it is near the time of the next dose, skip the missed dose.||
7367|176|D|Use your next dose at the regular time. Do not double the dose to||
7367|177|D|catch up.||
7367|178|B|||
7367|179|R|STORAGE:  Store at room temperature away from light and moisture.||
7367|180|R|Do not store in the bathroom. Keep all medications away from||
7367|181|R|children and pets.||
7367|182|R|   Do not flush medications down the toilet or pour them into a||
7367|183|R|drain unless instructed to do so. Properly discard this product||
7367|184|R|when it is expired or no longer needed. Consult your pharmacist||
7367|185|R|or local waste disposal company.||
7367|186|B|||
7367|187|A|Information last revised May 2025.||
7367|188|A|Copyright(c) 2025 First Databank, Inc.||
7367|189|B|||
7372|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7372|002|Z|does NOT have all possible information about this product. This||
7372|003|Z|information does not assure that this product is safe, effective,||
7372|004|Z|or appropriate for you. This information is not individual||
7372|005|Z|medical advice and does not substitute for the advice of your||
7372|006|Z|health care professional. Always ask your health care||
7372|007|Z|professional for complete information about this product and your||
7372|008|Z|specific health needs.||
7372|009|B|||
7372|010|T|TELMISARTAN - ORAL||
7372|011|F|(tel-mi-SAR-tan)||
7372|012|B|||
7372|013|C|COMMON BRAND NAME(S): Micardis||
7372|014|B|||
7372|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
7372|016|W|unborn baby if used during pregnancy. It is important to prevent||
7372|017|W|pregnancy while taking this medication. Consult your doctor for||
7372|018|W|more details and to discuss the use of reliable forms of birth||
7372|019|W|control while taking this medication. If you are planning||
7372|020|W|pregnancy, become pregnant, or think you may be pregnant, tell||
7372|021|W|your doctor right away.||
7372|022|B|||
7372|023|U|USES:  This medication is used to treat high blood pressure||
7372|024|U|(hypertension). Lowering high blood pressure helps prevent||
7372|025|U|strokes, heart attacks, and kidney problems. Telmisartan belongs||
7372|026|U|to a class of drugs called angiotensin receptor blockers (ARBs).||
7372|027|U|It works by relaxing blood vessels so blood can flow more easily.||
7372|028|B|||
7372|029|V|OTHER USES:  This section contains uses of this drug that are not||
7372|030|V|listed in the approved professional labeling for the drug but||
7372|031|V|that may be prescribed by your health care professional. Use this||
7372|032|V|drug for a condition that is listed in this section only if it||
7372|033|V|has been so prescribed by your health care professional.||
7372|034|V|   This drug may also be used for certain immune system diseases||
7372|035|V|(such as lupus). It may also be used for kidney disease.||
7372|036|B|||
7372|037|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7372|038|H|from your pharmacist before you start taking telmisartan and each||
7372|039|H|time you get a refill. If you have any questions, ask your doctor||
7372|040|H|or pharmacist.||
7372|041|H|   Take this medication by mouth with or without food as directed||
7372|042|H|by your doctor, usually once daily.||
7372|043|H|   The dosage is based on your medical condition and response to||
7372|044|H|treatment.||
7372|045|H|   Use this medication regularly to get the most benefit from it.||
7372|046|H|To help you remember, take it at the same time each day. Keep||
7372|047|H|taking this medication even if you feel well. Most people with||
7372|048|H|high blood pressure do not feel sick. For the treatment of high||
7372|049|H|blood pressure, it may take up to 4 weeks before you get the full||
7372|050|H|benefit of this drug.||
7372|051|H|   Tell your doctor if your condition does not get better or if||
7372|052|H|it gets worse (your blood pressure readings remain high or||
7372|053|H|increase).||
7372|054|B|||
7372|055|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
7372|056|S|body adjusts to the medication. If either of these effects lasts||
7372|057|S|or gets worse, tell your doctor or pharmacist promptly.||
7372|058|S|   To reduce the risk of dizziness and lightheadedness, get up||
7372|059|S|slowly when rising from a sitting or lying position.||
7372|060|S|   Remember that this medication has been prescribed because your||
7372|061|S|doctor has judged that the benefit to you is greater than the||
7372|062|S|risk of side effects. Many people using this medication do not||
7372|063|S|have serious side effects.||
7372|064|S|   Tell your doctor right away if you have any serious side||
7372|065|S|effects, including: fainting, symptoms of a high potassium blood||
7372|066|S|level (such as muscle weakness, slow/irregular heartbeat).||
7372|067|S|   Although telmisartan may be used to prevent kidney problems or||
7372|068|S|treat people who have kidney problems, it may also rarely cause||
7372|069|S|serious kidney problems or make them worse. Your doctor will||
7372|070|S|check your kidney function while you are taking telmisartan. Tell||
7372|071|S|your doctor right away if you have any signs of kidney problems||
7372|072|S|such as a change in the amount of urine.||
7372|073|S|   A very serious allergic reaction to this drug is rare.||
7372|074|S|However, get medical help right away if you notice any symptoms||
7372|075|S|of a serious allergic reaction, including: rash, itching/swelling||
7372|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7372|077|S|breathing.||
7372|078|S|   This is not a complete list of possible side effects. If you||
7372|079|S|notice other effects not listed above, contact your doctor or||
7372|080|S|pharmacist.||
7372|081|S|   In the US -||
7372|082|S|   Call your doctor for medical advice about side effects. You||
7372|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7372|084|S|www.fda.gov/medwatch.||
7372|085|S|   In Canada - Call your doctor for medical advice about side||
7372|086|S|effects. You may report side effects to Health Canada at||
7372|087|S|1-866-234-2345.||
7372|088|B|||
7372|089|P|PRECAUTIONS:  Before taking telmisartan, tell your doctor or||
7372|090|P|pharmacist if you are allergic to it; or if you have any other||
7372|091|P|allergies. This product may contain inactive ingredients, which||
7372|092|P|can cause allergic reactions or other problems. Talk to your||
7372|093|P|pharmacist for more details.||
7372|094|P|   Before using this medication, tell your doctor or pharmacist||
7372|095|P|your medical history, especially of: liver disease, bile duct||
7372|096|P|blockage, high level of potassium in the blood, dehydration.||
7372|097|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
7372|098|P|can make you more dizzy. Do not drive, use machinery, or do||
7372|099|P|anything that needs alertness until you can do it safely. Limit||
7372|100|P|alcoholic beverages. Talk to your doctor if you are using||
7372|101|P|marijuana (cannabis).||
7372|102|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
7372|103|P|and cause you to feel lightheaded. Tell your doctor if you have||
7372|104|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
7372|105|P|of fluids unless your doctor tells you not to.||
7372|106|P|   This product may increase your potassium levels. Before using||
7372|107|P|potassium supplements or salt substitutes that contain potassium,||
7372|108|P|consult your doctor or pharmacist.||
7372|109|P|   Before having surgery, tell your doctor or dentist about all||
7372|110|P|the products you use (including prescription drugs,||
7372|111|P|nonprescription drugs, and herbal products).||
7372|112|P|   Tell your doctor if you are pregnant or plan to become||
7372|113|P|pregnant. You should not become pregnant while using telmisartan.||
7372|114|P|Telmisartan may harm an unborn baby. If you become pregnant, talk||
7372|115|P|to your doctor right away about the risks and benefits of this||
7372|116|P|medication. (See also Warning section.)||
7372|117|P|   It is unknown if this drug passes into breast milk. Consult||
7372|118|P|your doctor before breastfeeding.||
7372|119|B|||
7372|120|I|DRUG INTERACTIONS:  See also Precautions section.||
7372|121|I|   Drug interactions may change how your medications work or||
7372|122|I|increase your risk for serious side effects. This document does||
7372|123|I|not contain all possible drug interactions. Keep a list of all||
7372|124|I|the products you use (including prescription/nonprescription||
7372|125|I|drugs and herbal products) and share it with your doctor and||
7372|126|I|pharmacist. Do not start, stop, or change the dosage of any||
7372|127|I|medicines without your doctor's approval.||
7372|128|I|   Some products that may interact with this drug include:||
7372|129|I|aliskiren, lithium, drugs that may increase the level of||
7372|130|I|potassium in the blood (such as sparsentan, ACE inhibitors||
7372|131|I|including benazepril/lisinopril, birth control pills containing||
7372|132|I|drospirenone).||
7372|133|I|   Some products have ingredients that could raise your blood||
7372|134|I|pressure or worsen your heart failure. Tell your pharmacist what||
7372|135|I|products you are using, and ask how to use them safely||
7372|136|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
7372|137|I|ibuprofen/naproxen).||
7372|138|B|||
7372|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
7372|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
7372|141|O|poison control center right away. US residents can call||
7372|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
7372|143|O|Symptoms of overdose may include: fast heartbeat, severe||
7372|144|O|dizziness, fainting.||
7372|145|B|||
7372|146|N|NOTES:  Do not share this medication with others.||
7372|147|N|   Lab and/or medical tests (such as kidney function, potassium||
7372|148|N|levels) should be done while you are taking this medication. Keep||
7372|149|N|all medical and lab appointments. Consult your doctor for more||
7372|150|N|details.||
7372|151|N|   Lifestyle changes that may help this medication work better||
7372|152|N|include stress reduction programs, exercise, and dietary changes.||
7372|153|N|Talk to your doctor or pharmacist about lifestyle changes that||
7372|154|N|might benefit you.||
7372|155|N|   Have your blood pressure checked regularly while taking this||
7372|156|N|medication. Learn how to monitor your own blood pressure at home,||
7372|157|N|and share the results with your doctor.||
7372|158|B|||
7372|159|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
7372|160|D|remember. If it is near the time of the next dose, skip the||
7372|161|D|missed dose. Take your next dose at the regular time. Do not||
7372|162|D|double the dose to catch up.||
7372|163|B|||
7372|164|R|STORAGE:  Store at room temperature away from light and moisture.||
7372|165|R|Do not remove the medication from the blister pack until right||
7372|166|R|before using. Do not store in the bathroom. Keep all medications||
7372|167|R|away from children and pets.||
7372|168|R|   Do not flush medications down the toilet or pour them into a||
7372|169|R|drain unless instructed to do so. Properly discard this product||
7372|170|R|when it is expired or no longer needed. Consult your pharmacist||
7372|171|R|or local waste disposal company.||
7372|172|B|||
7372|173|A|Information last revised September 2024.||
7372|174|A|Copyright(c) 2025 First Databank, Inc.||
7372|175|B|||
7378|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
7378|002|Z|does NOT have all possible information about this product. This||
7378|003|Z|information does not assure that this product is safe, effective,||
7378|004|Z|or appropriate for you. This information is not individual||
7378|005|Z|medical advice and does not substitute for the advice of your||
7378|006|Z|health care professional. Always ask your health care||
7378|007|Z|professional for complete information about this product and your||
7378|008|Z|specific health needs.||
7378|009|B|||
7378|010|T|ESTRADIOL WEEKLY - TRANSDERMAL (14 MCG/24 HR)||
7378|011|F|(ES-tra-DYE-ol)||
7378|012|B|||
7378|013|C|COMMON BRAND NAME(S): Menostar||
7378|014|B|||
7378|015|W|WARNING:  Estrogens, either used alone or with another hormone||
7378|016|W|(progestin), have rarely caused very serious side effects.||
7378|017|W|Discuss the risks and benefits of hormone treatment with your||
7378|018|W|doctor. Estrogens should not be used to prevent heart disease or||
7378|019|W|dementia.||
7378|020|W|   Estrogens can increase the risk of cancer of the uterus||
7378|021|W|(endometrial cancer). Taking a progestin as directed by your||
7378|022|W|doctor can help decrease this risk. Tell your doctor right away||
7378|023|W|if you have any unusual vaginal bleeding.||
7378|024|W|   In postmenopausal women, estrogens, taken with or without a||
7378|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
7378|026|W|stroke, dementia, and serious blood clots. When used along with a||
7378|027|W|progestin, estrogens also increase the risk of heart disease||
7378|028|W|(such as heart attacks).||
7378|029|W|   The risk for serious side effects may depend on the dose of||
7378|030|W|estrogen and the length of time it is used. This medication||
7378|031|W|should be used at the lowest effective dose and for the shortest||
7378|032|W|amount of time. Discuss the use of this medication with your||
7378|033|W|doctor regularly (for example, every 3 to 6 months) to see if you||
7378|034|W|still need to use it. If you will be using this medication||
7378|035|W|long-term, you should have regular complete physical exams (for||
7378|036|W|example, once a year) as directed by your doctor. See also Notes||
7378|037|W|section.||
7378|038|B|||
7378|039|U|USES:  This medication is a hormone (estrogen). It is used by||
7378|040|U|women after menopause to prevent bone loss (osteoporosis).||
7378|041|U|However, there are other medications (such as raloxifene,||
7378|042|U|bisphosphonates including alendronate) that are also effective in||
7378|043|U|preventing bone loss and may be safer. These medications should||
7378|044|U|be considered for use before estrogen treatment.||
7378|045|B|||
7378|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
7378|047|H|from your pharmacist before you start using this medication and||
7378|048|H|each time you get a refill. If you have any questions, ask your||
7378|049|H|doctor or pharmacist.||
7378|050|H|   Peel off the backing from the patch and apply the patch to a||
7378|051|H|clean, dry area of the lower stomach. Press the patch firmly in||
7378|052|H|place for about 10 seconds to make sure it stays on. Do not apply||
7378|053|H|the patch on the breast or on oily, broken, or irritated skin.||
7378|054|H|Avoid applying the patch to areas of the skin where it might be||
7378|055|H|easily rubbed off (such as the waistline). Use this medication as||
7378|056|H|directed by your doctor. The patch is usually worn for 1 week and||
7378|057|H|then replaced. Follow the dosing schedule carefully.||
7378|058|H|   When replacing your patch, make sure to apply the new patch to||
7378|059|H|a different area. Wait at least 1 week before applying a patch to||
7378|060|H|the same area. Fold the old patch in half with the sticky side||
7378|061|H|together and throw away in the trash away from children and pets.||
7378|062|H|Do not flush the patch down the toilet.||
7378|063|H|   If a patch falls off, reapply it to a different area. If the||
7378|064|H|patch does not stick completely, then apply a new patch and wear||
7378|065|H|it for the rest of the 7-day period. Do not wear 2 patches at the||
7378|066|H|same time.||
7378|067|H|   Use this medication regularly to get the most benefit from it.||
7378|068|H|To help you remember, change the patch on the same day each week.||
7378|069|H|Mark your calendar with a reminder.||
7378|070|B|||
7378|071|S|SIDE EFFECTS:  See also Warning section.||
7378|072|S|   Skin redness/irritation at the application site,||
7378|073|S|nausea/vomiting, bloating, breast tenderness, headache, or weight||
7378|074|S|changes may occur. If any of these effects last or get worse,||
7378|075|S|tell your doctor or pharmacist promptly.||
7378|076|S|   Remember that this medication has been prescribed because your||
7378|077|S|doctor has judged that the benefit to you is greater than the||
7378|078|S|risk of side effects. Many people using this medication do not||
7378|079|S|have serious side effects.||
7378|080|S|   Tell your doctor right away if you have any serious side||
7378|081|S|effects, including: nausea/vomiting that doesn't stop,||
7378|082|S|mental/mood changes (such as depression, memory loss), breast||
7378|083|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
7378|084|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
7378|085|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
7378|086|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
7378|087|S|increased thirst/urination.||
7378|088|S|   This medication may rarely cause serious (sometimes fatal)||
7378|089|S|problems from blood clots (such as heart attack, stroke, blood||
7378|090|S|clots in the lungs or legs). Get medical help right away if you||
7378|091|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
7378|092|S|headaches, weakness on one side of the body, confusion, trouble||
7378|093|S|speaking, sudden vision changes, pain/swelling/warmth in the||
7378|094|S|groin/calf, shortness of breath/rapid breathing, sudden||
7378|095|S|dizziness/fainting.||
7378|096|S|   A very serious allergic reaction to this product is rare.||
7378|097|S|However, get medical help right away if you notice any symptoms||
7378|098|S|of a serious allergic reaction, including: rash, itching/swelling||
7378|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
7378|100|S|breathing.||
7378|101|S|   This is not a complete list of possible side effects. If you||
7378|102|S|notice other effects not listed above, contact your doctor or||
7378|103|S|pharmacist.||
7378|104|S|   In the US -||
7378|105|S|   Call your doctor for medical advice about side effects. You||
7378|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
7378|107|S|www.fda.gov/medwatch.||
7378|108|S|   In Canada - Call your doctor for medical advice about side||
7378|109|S|effects. You may report side effects to Health Canada at||
7378|110|S|1-866-234-2345.||
7378|111|B|||
7378|112|P|PRECAUTIONS:  Before using estradiol, tell your doctor or||
7378|113|P|pharmacist if you are allergic to it; or if you have any other||
7378|114|P|allergies. This product may contain inactive ingredients, which||
7378|115|P|can cause allergic reactions or other problems. Talk to your||
7378|116|P|pharmacist for more details.||
7378|117|P|   Before using this medication, tell your doctor or pharmacist||
7378|118|P|your medical history, especially of: vaginal bleeding of unknown||
7378|119|P|cause, certain cancers (such as breast cancer, cancer of the||
7378|120|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
7378|121|P|heart attack), liver disease, kidney disease, family medical||
7378|122|P|history (especially breast lumps, cancer, blood clots), family or||
7378|123|P|personal history of a certain swelling disorder (angioedema),||
7378|124|P|blood clotting disorders (such as protein C or protein S||
7378|125|P|deficiency), high blood pressure, diabetes, high||
7378|126|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
7378|127|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
7378|128|P|calcium in the blood), a certain hormone problem||
7378|129|P|(hypoparathyroidism), uterus problems (such as fibroids,||
7378|130|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
7378|131|P|headaches, a certain blood disorder (porphyria), mental/mood||
7378|132|P|disorders (such as dementia, depression).||
7378|133|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
7378|134|P|further increases your risk of stroke, blood clots, high blood||
7378|135|P|pressure, and heart attack, especially in women older than 35.||
7378|136|P|   Tell your doctor if you just had or will be having surgery, or||
7378|137|P|if you will be confined to a chair or bed for a long time (such||
7378|138|P|as a long plane flight). These conditions increase your risk of||
7378|139|P|getting blood clots, especially if you are using an estrogen||
7378|140|P|product. You may need to stop this medication for a time or take||
7378|141|P|special precautions.||
7378|142|P|   This medication may cause blotchy, dark areas on your face and||
7378|143|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
7378|144|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
7378|145|P|wear protective clothing when outdoors.||
7378|146|P|   If you are nearsighted or wear contact lenses, you may develop||
7378|147|P|vision problems or trouble wearing your contact lenses. Contact||
7378|148|P|your eye doctor if these problems occur.||
7378|149|P|   If you are going to have an MRI test, tell testing personnel||
7378|150|P|that you are using this patch. Some patches may contain metals||
7378|151|P|that can cause serious burns during an MRI. Ask your doctor||
7378|152|P|whether you will need to remove your patch before the test and||
7378|153|P|apply a new patch afterward, and how to do so properly.||
7378|154|P|   Children may be more sensitive to the side effects of this||
7378|155|P|drug. It may affect their growth/development. Discuss the||
7378|156|P|possible effects of this medication with the doctor, and monitor||
7378|157|P|your child's growth periodically.||
7378|158|P|   This medication should not be used during pregnancy. If you||
7378|159|P|become pregnant or think you may be pregnant, tell your doctor||
7378|160|P|right away.||
7378|161|P|   This medication passes into breast milk. Consult your doctor||
7378|162|P|before breastfeeding.||
7378|163|B|||
7378|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
7378|165|I|medications work or increase your risk for serious side effects.||
7378|166|I|This document does not contain all possible drug interactions.||
7378|167|I|Keep a list of all the products you use (including||
7378|168|I|prescription/nonprescription drugs and herbal products) and share||
7378|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
7378|170|I|the dosage of any medicines without your doctor's approval.||
7378|171|I|   Some products that may interact with this drug include:||
7378|172|I|aromatase inhibitors (such as anastrozole, exemestane,||
7378|173|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
7378|174|I|tamoxifen, toremifene, tranexamic acid.||
7378|175|I|   This medication may interfere with certain lab tests (such as||
7378|176|I|metyrapone test), possibly causing false test results. Make sure||
7378|177|I|lab personnel and all your doctors know you use this drug.||
7378|178|B|||
7378|179|O|OVERDOSE:  This medication patch may be harmful if chewed or||
7378|180|O|swallowed. If someone has overdosed, remove the patch if||
7378|181|O|possible. For serious symptoms such as passing out or trouble||
7378|182|O|breathing, call 911. Otherwise, call a poison control center||
7378|183|O|right away. US residents can call 1-800-222-1222. Canada||
7378|184|O|residents can call 1-844-764-7669.||
7378|185|B|||
7378|186|N|NOTES:  Do not share this medication with others.||
7378|187|N|   Regular complete physical exams which include lab and/or||
7378|188|N|medical tests (such as blood pressure, breast exam/mammogram,||
7378|189|N|pelvic exam, Pap smear) should be done while you are using this||
7378|190|N|medication. Follow your doctor's instructions for examining your||
7378|191|N|breasts, and report any lumps right away. Keep all medical and||
7378|192|N|lab appointments. Consult your doctor for more details.||
7378|193|N|   Lifestyle changes that help promote healthy bones include||
7378|194|N|increasing weight-bearing exercise, stopping smoking, limiting||
7378|195|N|alcohol, and eating well-balanced meals that contain adequate||
7378|196|N|calcium and vitamin D. Since you may also need to take calcium||
7378|197|N|and vitamin D supplements and make lifestyle changes, consult||
7378|198|N|your doctor for specific advice.||
7378|199|N|   Preventing or controlling high blood pressure, high||
7378|200|N|cholesterol, and diabetes can help to reduce your chances of||
7378|201|N|heart disease and stroke. Lifestyle changes that can help to||
7378|202|N|control or prevent these diseases include reducing stress, eating||
7378|203|N|a low fat/salt diet, losing weight if overweight, exercising||
7378|204|N|regularly, and stopping smoking. Keep your mind active with||
7378|205|N|mental exercises (such as reading, solving crossword puzzles) to||
7378|206|N|help prevent dementia. Talk to your doctor about lifestyle||
7378|207|N|changes that might benefit you.||
7378|208|B|||
7378|209|D|MISSED DOSE:  If you forget to replace a patch at the scheduled||
7378|210|D|time, replace it as soon as you remember. Do not use more than||
7378|211|D|one patch at a time.||
7378|212|B|||
7378|213|R|STORAGE:  Store at room temperature. Do not remove the patch from||
7378|214|R|the pouch until ready for use. Keep all medications away from||
7378|215|R|children and pets.||
7378|216|R|   Do not flush medications down the toilet or pour them into a||
7378|217|R|drain unless instructed to do so. Properly discard this product||
7378|218|R|when it is expired or no longer needed (See How to Use section).||
7378|219|B|||
7378|220|A|Information last revised October 2024.||
7378|221|A|Copyright(c) 2025 First Databank, Inc.||
7378|222|B|||
8003|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8003|002|Z|does NOT have all possible information about this product. This||
8003|003|Z|information does not assure that this product is safe, effective,||
8003|004|Z|or appropriate for you. This information is not individual||
8003|005|Z|medical advice and does not substitute for the advice of your||
8003|006|Z|health care professional. Always ask your health care||
8003|007|Z|professional for complete information about this product and your||
8003|008|Z|specific health needs.||
8003|009|B|||
8003|010|T|SALSALATE - ORAL||
8003|011|F|(SAL-suh-late)||
8003|012|B|||
8003|013|C|COMMON BRAND NAME(S): Disalcid||
8003|014|B|||
8003|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
8003|016|W|salsalate) may rarely increase the risk for a heart attack or||
8003|017|W|stroke. This effect does not apply to low-dose aspirin. (See Drug||
8003|018|W|Interactions section.) This effect can happen at any time while||
8003|019|W|taking this drug but is more likely if you take it for a long||
8003|020|W|time. The risk may be greater if you have heart disease or||
8003|021|W|increased risk for heart disease (for example, due to smoking,||
8003|022|W|family history of heart disease, or conditions such as high blood||
8003|023|W|pressure or diabetes). Do not take this drug right before or||
8003|024|W|after heart bypass surgery (CABG). Also, this drug may rarely||
8003|025|W|cause serious (rarely fatal) bleeding from the stomach or||
8003|026|W|intestines. This bleeding can occur without warning symptoms at||
8003|027|W|any time during treatment.||
8003|028|W|   Stop taking this medication and get medical help right away if||
8003|029|W|you notice any of the following rare but very serious side||
8003|030|W|effects: stomach/abdominal pain that doesn't go away, chest pain,||
8003|031|W|severe dizziness, weakness on one side of the body, sudden vision||
8003|032|W|changes, trouble speaking, black stools, vomit that looks like||
8003|033|W|coffee grounds. (See also Precautions section.)||
8003|034|W|   Talk with your doctor or pharmacist about the risks and||
8003|035|W|benefits of treatment with this medication.||
8003|036|B|||
8003|037|U|USES:  Salsalate is used to relieve pain from various conditions.||
8003|038|U|It also reduces pain, swelling, and joint stiffness from||
8003|039|U|arthritis. This medication is known as a nonsteroidal||
8003|040|U|anti-inflammatory drug (NSAID).||
8003|041|B|||
8003|042|H|HOW TO USE:  Take this medication by mouth as directed by your||
8003|043|H|doctor, usually 2 to 3 times daily with a full glass of water (8||
8003|044|H|ounces or 240 milliliters). Do not lie down for at least 10||
8003|045|H|minutes after taking this drug. If stomach upset occurs while||
8003|046|H|taking this medication, take it with food, milk, or an antacid.||
8003|047|H|   The dosage is based on your medical condition and response to||
8003|048|H|treatment. To reduce your risk of stomach bleeding and other side||
8003|049|H|effects, take this medication at the lowest effective dose for||
8003|050|H|the shortest possible time. Do not increase your dose, take it||
8003|051|H|more often, or take it for a longer time than prescribed. For||
8003|052|H|ongoing conditions such as arthritis, keep taking this medication||
8003|053|H|as directed. Discuss the risks and benefits with your doctor or||
8003|054|H|pharmacist.||
8003|055|H|   For certain conditions (such as arthritis), it may take up to||
8003|056|H|2 weeks of taking this drug regularly until you get the full||
8003|057|H|benefit.||
8003|058|H|   If you are taking this drug "as needed" (not on a regular||
8003|059|H|schedule), remember that pain medications work best if they are||
8003|060|H|used as the first signs of pain occur. If you wait until the||
8003|061|H|symptoms have worsened, the medicine may not work as well.||
8003|062|H|   Tell your doctor if your symptoms last or get worse or if you||
8003|063|H|develop new symptoms.||
8003|064|B|||
8003|065|S|SIDE EFFECTS:  Upset stomach, dizziness, or nausea may occur. If||
8003|066|S|any of these effects last or get worse, tell your doctor or||
8003|067|S|pharmacist promptly.||
8003|068|S|   Remember that this medication has been prescribed because your||
8003|069|S|doctor has judged that the benefit to you is greater than the||
8003|070|S|risk of side effects. Many people using this medication do not||
8003|071|S|have serious side effects.||
8003|072|S|   This medication may raise your blood pressure. Check your||
8003|073|S|blood pressure regularly and tell your doctor if the results are||
8003|074|S|high.||
8003|075|S|   Tell your doctor right away if you have any serious side||
8003|076|S|effects, including: heartburn, hearing changes (such as ringing||
8003|077|S|in the ears, decreased hearing), easy bruising/bleeding,||
8003|078|S|fast/pounding heartbeat, signs of infection (such as sore throat||
8003|079|S|that doesn't go away, fever, chills), signs of kidney problems||
8003|080|S|(such as change in the amount of urine), symptoms of heart||
8003|081|S|failure (such as swelling ankles/feet, unusual tiredness,||
8003|082|S|unusual/sudden weight gain).||
8003|083|S|   This drug may rarely cause serious (possibly fatal) liver||
8003|084|S|disease. Get medical help right away if you have any symptoms of||
8003|085|S|liver damage, including: nausea/vomiting that doesn't stop, dark||
8003|086|S|urine, yellowing eyes/skin, loss of appetite, stomach/abdominal||
8003|087|S|pain.||
8003|088|S|   A very serious allergic reaction to this drug is rare.||
8003|089|S|However, get medical help right away if you notice any symptoms||
8003|090|S|of a serious allergic reaction, including: rash, itching/swelling||
8003|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8003|092|S|breathing.||
8003|093|S|   This is not a complete list of possible side effects. If you||
8003|094|S|notice other effects not listed above, contact your doctor or||
8003|095|S|pharmacist.||
8003|096|S|   In the US -||
8003|097|S|   Call your doctor for medical advice about side effects. You||
8003|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8003|099|S|www.fda.gov/medwatch.||
8003|100|S|   In Canada - Call your doctor for medical advice about side||
8003|101|S|effects. You may report side effects to Health Canada at||
8003|102|S|1-866-234-2345.||
8003|103|B|||
8003|104|P|PRECAUTIONS:  Before taking salsalate, tell your doctor or||
8003|105|P|pharmacist if you are allergic to it; or to aspirin or other||
8003|106|P|NSAIDs (such as ibuprofen, naproxen, celecoxib); or to salicylic||
8003|107|P|acid; or if you have any other allergies. This product may||
8003|108|P|contain inactive ingredients, which can cause allergic reactions||
8003|109|P|or other problems. Talk to your pharmacist for more details.||
8003|110|P|   Before using this medication, tell your doctor or pharmacist||
8003|111|P|your medical history, especially of: liver disease, diabetes,||
8003|112|P|stomach/intestine/esophagus problems (such as bleeding, ulcers,||
8003|113|P|recurring heartburn), heart disease (such as history of heart||
8003|114|P|attack), high blood pressure, stroke, swelling of the||
8003|115|P|ankles/feet/hands, blood disorders (such as anemia),||
8003|116|P|bleeding/clotting problems, asthma (including a history of||
8003|117|P|worsening breathing after taking aspirin or other NSAIDs),||
8003|118|P|growths in the nose (nasal polyps), certain genetic conditions||
8003|119|P|(G-6-PD deficiency, pyruvate kinase deficiency).||
8003|120|P|   Kidney problems can sometimes occur with the use of NSAID||
8003|121|P|medications, including salsalate. Problems are more likely to||
8003|122|P|occur if you are dehydrated, have heart failure or kidney||
8003|123|P|disease, are an older adult, or if you take certain medications||
8003|124|P|(see also Drug Interactions section). Drink plenty of fluids as||
8003|125|P|directed by your doctor to prevent dehydration and tell your||
8003|126|P|doctor right away if you have a change in the amount of urine.||
8003|127|P|   Before having surgery, tell your doctor or dentist about all||
8003|128|P|the products you use (including prescription drugs,||
8003|129|P|nonprescription drugs, and herbal products).||
8003|130|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8003|131|P|can make you more dizzy. Do not drive, use machinery, or do||
8003|132|P|anything that needs alertness until you can do it safely. Limit||
8003|133|P|alcoholic beverages. Talk to your doctor if you are using||
8003|134|P|marijuana (cannabis).||
8003|135|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
8003|136|P|and tobacco, especially when combined with this medicine, may||
8003|137|P|increase your risk for stomach bleeding. Limit alcohol and stop||
8003|138|P|smoking. Consult your doctor or pharmacist for more information.||
8003|139|P|   Older adults may be at greater risk for stomach bleeding and||
8003|140|P|kidney problems.||
8003|141|P|   This medication is similar to aspirin. Children and teenagers||
8003|142|P|younger than 18 years should not take this medication if they||
8003|143|P|have chickenpox, flu, or any undiagnosed illness, or if they have||
8003|144|P|just been given a live virus vaccine, without first consulting a||
8003|145|P|doctor about Reye's syndrome, a rare but serious illness.||
8003|146|P|   Tell your doctor if you are pregnant or if you plan to become||
8003|147|P|pregnant. This medication may harm an unborn baby and cause||
8003|148|P|problems with normal labor/delivery. It is not recommended for||
8003|149|P|use in pregnancy from 20 weeks until delivery. If your doctor||
8003|150|P|decides that you need to use this medication between 20 and 30||
8003|151|P|weeks of pregnancy, you should use the lowest effective dose for||
8003|152|P|the shortest possible time. You should not use this medication||
8003|153|P|after 30 weeks of pregnancy. Discuss the risks and benefits with||
8003|154|P|your doctor.||
8003|155|P|   This drug may pass into breast milk and could have undesirable||
8003|156|P|effects on a nursing infant. Breastfeeding is not recommended||
8003|157|P|while using this drug long-term and in high doses. Consult your||
8003|158|P|doctor before breastfeeding.||
8003|159|B|||
8003|160|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8003|161|I|medications work or increase your risk for serious side effects.||
8003|162|I|This document does not contain all possible drug interactions.||
8003|163|I|Keep a list of all the products you use (including||
8003|164|I|prescription/nonprescription drugs and herbal products) and share||
8003|165|I|it with your doctor and pharmacist. Do not start, stop, or change||
8003|166|I|the dosage of any medicines without your doctor's approval.||
8003|167|I|   Some products that may interact with this drug include:||
8003|168|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
8003|169|I|angiotensin II receptor blockers (such as losartan, valsartan),||
8003|170|I|certain drugs for seizures (phenytoin, valproic acid), cidofovir,||
8003|171|I|corticosteroids (such as prednisone), dichlorphenamide, drugs for||
8003|172|I|gout (such as probenecid), drugs that affect the acidity of urine||
8003|173|I|(such as ammonium chloride, acetazolamide), lithium,||
8003|174|I|methotrexate, pemetrexed, tenofovir.||
8003|175|I|   This medication may increase the risk of bleeding when taken||
8003|176|I|with other drugs that also may cause bleeding. Examples include||
8003|177|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
8003|178|I|dabigatran/enoxaparin/warfarin, among others.||
8003|179|I|   Check all prescription and nonprescription medicine labels||
8003|180|I|carefully since many contain pain relievers/fever reducers||
8003|181|I|(NSAIDs such as aspirin, ibuprofen, ketorolac, or naproxen) that||
8003|182|I|are similar to this drug and, if taken together, may increase||
8003|183|I|your risk for side effects. However, if your doctor has told you||
8003|184|I|to take low-dose aspirin to prevent heart attack or stroke||
8003|185|I|(usually 81-162 milligrams a day), you should keep taking the||
8003|186|I|aspirin unless your doctor tells you not to. Ask your doctor or||
8003|187|I|pharmacist for more details.||
8003|188|I|   This medication may interfere with certain lab tests (such as||
8003|189|I|certain urine glucose tests, thyroid hormone levels), possibly||
8003|190|I|causing false test results. Make sure lab personnel and all your||
8003|191|I|doctors know you use this drug.||
8003|192|B|||
8003|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8003|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8003|195|O|poison control center right away. US residents can call||
8003|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8003|197|O|Symptoms of overdose may include: ringing in the ears, confusion,||
8003|198|O|vomiting, diarrhea, dizziness, fast breathing, seizures.||
8003|199|B|||
8003|200|N|NOTES:  Do not share this medication with others.||
8003|201|N|   Lab and/or medical tests (such as blood pressure, complete||
8003|202|N|blood count, liver/kidney function, salicylic acid levels) may be||
8003|203|N|done while you are taking this medication. Keep all medical and||
8003|204|N|lab appointments. Consult your doctor for more details.||
8003|205|N|   If you have arthritis, lifestyle changes (such as weight loss||
8003|206|N|if needed, strengthening/conditioning exercises) may help improve||
8003|207|N|your flexibility and joint function. Consult your doctor for||
8003|208|N|specific instructions.||
8003|209|B|||
8003|210|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
8003|211|D|(not "as needed") and you miss a dose, take it as soon as you||
8003|212|D|remember. If it is near the time of the next dose, skip the||
8003|213|D|missed dose. Take your next dose at the regular time. Do not||
8003|214|D|double the dose to catch up.||
8003|215|B|||
8003|216|R|STORAGE:  Store at room temperature away from light and moisture.||
8003|217|R|Do not store in the bathroom. Keep all medications away from||
8003|218|R|children and pets.||
8003|219|R|   Do not flush medications down the toilet or pour them into a||
8003|220|R|drain unless instructed to do so. Properly discard this product||
8003|221|R|when it is expired or no longer needed. Consult your pharmacist||
8003|222|R|or local waste disposal company.||
8003|223|B|||
8003|224|A|Information last revised May 2025.||
8003|225|A|Copyright(c) 2025 First Databank, Inc.||
8003|226|B|||
8004|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8004|002|Z|does NOT have all possible information about this product. This||
8004|003|Z|information does not assure that this product is safe, effective,||
8004|004|Z|or appropriate for you. This information is not individual||
8004|005|Z|medical advice and does not substitute for the advice of your||
8004|006|Z|health care professional. Always ask your health care||
8004|007|Z|professional for complete information about this product and your||
8004|008|Z|specific health needs.||
8004|009|B|||
8004|010|T|HYOSCYAMINE - ORAL||
8004|011|F|(hi-oh-SYE-uh-meen)||
8004|012|B|||
8004|013|C|COMMON BRAND NAME(S): Anaspaz, Cystospaz, Donnamar, Levsin||
8004|014|B|||
8004|015|U|USES:  Hyoscyamine is used to treat a variety of||
8004|016|U|stomach/intestinal problems such as cramps and irritable bowel||
8004|017|U|syndrome. It is also used to treat other conditions such as||
8004|018|U|bladder and bowel control problems, cramping pain caused by||
8004|019|U|kidney stones and gallstones, and Parkinson's disease. In||
8004|020|U|addition, it is used to decrease side effects of certain||
8004|021|U|medications (drugs used to treat myasthenia gravis) and||
8004|022|U|insecticides.||
8004|023|U|   This medication works by decreasing acid production in the||
8004|024|U|stomach, slowing down the natural movements of the gut, and||
8004|025|U|relaxing muscles in many organs (such as the stomach, intestines,||
8004|026|U|bladder, kidney, gallbladder). Hyoscyamine also lessens the||
8004|027|U|amount of certain body fluids (such as saliva, sweat). This||
8004|028|U|medication belongs to a class of drugs known as||
8004|029|U|anticholinergics/antispasmodics.||
8004|030|B|||
8004|031|H|HOW TO USE:  Take this medication by mouth as directed by your||
8004|032|H|doctor, usually 30 to 60 minutes before meals.||
8004|033|H|   The dosage is based on your medical condition and response to||
8004|034|H|treatment. Do not increase your dose or take it more often than||
8004|035|H|prescribed without consulting your doctor. Adults and children 12||
8004|036|H|years and older should not take more than 1.5 milligrams in 24||
8004|037|H|hours. Children aged 2 to 12 years should not take more than 0.75||
8004|038|H|milligrams in 24 hours. Ask your doctor or pharmacist for more||
8004|039|H|information.||
8004|040|H|   Antacids lower the absorption of hyoscyamine. If you use||
8004|041|H|antacids, take them after meals and take hyoscyamine before||
8004|042|H|meals; or take antacids at least 1 hour after taking hyoscyamine.||
8004|043|H|   Drink plenty of fluids while taking this medication unless||
8004|044|H|your doctor directs you otherwise.||
8004|045|H|   Tell your doctor if your condition lasts or gets worse.||
8004|046|B|||
8004|047|S|SIDE EFFECTS:  Dizziness, drowsiness, blurred vision, dry mouth,||
8004|048|S|vision problems, headache, trouble sleeping, constipation,||
8004|049|S|flushing, dry skin, and decreased sweating may occur. If any of||
8004|050|S|these effects last or get worse, tell your doctor or pharmacist||
8004|051|S|promptly.||
8004|052|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
8004|053|S|chips, chew (sugarless) gum, drink water or use a saliva||
8004|054|S|substitute.||
8004|055|S|   Remember that this medication has been prescribed because your||
8004|056|S|doctor has judged that the benefit to you is greater than the||
8004|057|S|risk of side effects. Many people using this medication do not||
8004|058|S|have serious side effects.||
8004|059|S|   Tell your doctor right away if you have any serious side||
8004|060|S|effects, including: mental/mood changes (such as confusion,||
8004|061|S|unusual excitement), fast/irregular heartbeat, difficulty||
8004|062|S|urinating, decreased sexual ability, loss of coordination,||
8004|063|S|trouble speaking, vomiting.||
8004|064|S|   Get medical help right away if you have any very serious side||
8004|065|S|effects, including: eye pain/swelling/redness, vision changes||
8004|066|S|(such as seeing rainbows around lights at night).||
8004|067|S|   A very serious allergic reaction to this drug is rare.||
8004|068|S|However, get medical help right away if you notice any symptoms||
8004|069|S|of a serious allergic reaction, including: rash, itching/swelling||
8004|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8004|071|S|breathing.||
8004|072|S|   This is not a complete list of possible side effects. If you||
8004|073|S|notice other effects not listed above, contact your doctor or||
8004|074|S|pharmacist.||
8004|075|S|   In the US -||
8004|076|S|   Call your doctor for medical advice about side effects. You||
8004|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8004|078|S|www.fda.gov/medwatch.||
8004|079|S|   In Canada - Call your doctor for medical advice about side||
8004|080|S|effects. You may report side effects to Health Canada at||
8004|081|S|1-866-234-2345.||
8004|082|B|||
8004|083|P|PRECAUTIONS:  Before taking hyoscyamine, tell your doctor or||
8004|084|P|pharmacist if you are allergic to it; or to atropine; or if you||
8004|085|P|have any other allergies. This product may contain inactive||
8004|086|P|ingredients, which can cause allergic reactions or other||
8004|087|P|problems. Talk to your pharmacist for more details.||
8004|088|P|   Before using this medication, tell your doctor or pharmacist||
8004|089|P|your medical history, especially of: enlarged prostate, urinary||
8004|090|P|blockage problems, certain stomach/intestinal problems (such as||
8004|091|P|slow gut, blockage, severe ulcerative colitis, infection),||
8004|092|P|personal or family history of glaucoma (angle-closure type),||
8004|093|P|overactive thyroid, heart problems (such as coronary heart||
8004|094|P|disease, heart failure, fast heartbeat, arrhythmias), high blood||
8004|095|P|pressure, kidney disease, heartburn problems (acid reflux, hiatal||
8004|096|P|hernia), certain nervous system problem (autonomic neuropathy),||
8004|097|P|myasthenia gravis.||
8004|098|P|   Contact lens wearers may need to use wetting eye drops since||
8004|099|P|this medication can cause dry eyes.||
8004|100|P|   This drug may make you dizzy or drowsy or blur your vision.||
8004|101|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8004|102|P|drowsy. Do not drive, use machinery, or do anything that needs||
8004|103|P|alertness or clear vision until you can do it safely. Limit||
8004|104|P|alcoholic beverages. Talk to your doctor if you are using||
8004|105|P|marijuana (cannabis).||
8004|106|P|   Before having surgery, tell your doctor or dentist about all||
8004|107|P|the products you use (including prescription drugs,||
8004|108|P|nonprescription drugs, and herbal products).||
8004|109|P|   This drug may make you sweat less, making you more likely to||
8004|110|P|get heat stroke. Avoid doing things that may cause you to||
8004|111|P|overheat, such as hard work or exercise in hot weather, or using||
8004|112|P|hot tubs. When the weather is hot, drink a lot of fluids and||
8004|113|P|dress lightly. If you overheat, quickly look for a place to cool||
8004|114|P|down and rest. Get medical help right away if you have a fever||
8004|115|P|that does not go away, mental/mood changes, headache, or||
8004|116|P|dizziness.||
8004|117|P|   Older adults may be more sensitive to the side effects of this||
8004|118|P|drug, especially confusion, drowsiness, unusual excitement,||
8004|119|P|constipation, and difficulty urinating. Confusion and drowsiness||
8004|120|P|can increase the risk of falling.||
8004|121|P|   Children may be more sensitive to the side effects of this||
8004|122|P|drug.||
8004|123|P|   During pregnancy, hyoscyamine should be used only when clearly||
8004|124|P|needed. Discuss the risks and benefits with your doctor.||
8004|125|P|   This drug passes into breast milk. Consult your doctor before||
8004|126|P|breastfeeding.||
8004|127|B|||
8004|128|I|DRUG INTERACTIONS:  See also How to Use section.||
8004|129|I|   Drug interactions may change how your medications work or||
8004|130|I|increase your risk for serious side effects. This document does||
8004|131|I|not contain all possible drug interactions. Keep a list of all||
8004|132|I|the products you use (including prescription/nonprescription||
8004|133|I|drugs and herbal products) and share it with your doctor and||
8004|134|I|pharmacist. Do not start, stop, or change the dosage of any||
8004|135|I|medicines without your doctor's approval.||
8004|136|I|   Some products that may interact with this drug are: certain||
8004|137|I|azole anti-fungal drugs (ketoconazole, itraconazole),||
8004|138|I|bisphosphonate drugs (such as alendronate, risedronate),||
8004|139|I|corticosteroids (such as prednisone), digoxin (slow-dissolving||
8004|140|I|tablets), potassium tablets/capsules, pramlintide.||
8004|141|I|   Tell your doctor or pharmacist if you are taking other||
8004|142|I|products that cause drowsiness such as opioid pain or cough||
8004|143|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8004|144|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
8004|145|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
8004|146|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8004|147|I|diphenhydramine).||
8004|148|I|   Check the labels on all your medicines (such as allergy or||
8004|149|I|cough-and-cold products) because they may contain ingredients||
8004|150|I|that cause drowsiness. Ask your pharmacist about using those||
8004|151|I|products safely.||
8004|152|I|   This medication may interfere with certain lab tests, possibly||
8004|153|I|causing false test results. Make sure lab personnel and all your||
8004|154|I|doctors know you use this drug.||
8004|155|B|||
8004|156|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8004|157|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8004|158|O|poison control center right away. US residents can call||
8004|159|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8004|160|O|Symptoms of overdose may include hot/dry skin, fever, unusual||
8004|161|O|excitement, fast/irregular heartbeat, seizures.||
8004|162|B|||
8004|163|N|NOTES:  Do not share this medication with others.||
8004|164|N|   Management of digestive disorders may include lifestyle||
8004|165|N|changes such as stress reduction programs, exercise, stopping||
8004|166|N|smoking, and dietary changes to increase the effectiveness of||
8004|167|N|this medicine. Talk to your doctor or pharmacist about lifestyle||
8004|168|N|changes that might benefit you.||
8004|169|B|||
8004|170|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8004|171|D|remember. If it is near the time of the next dose, skip the||
8004|172|D|missed dose. Take your next dose at the regular time. Do not||
8004|173|D|double the dose to catch up.||
8004|174|B|||
8004|175|R|STORAGE:  Store at room temperature away from light and moisture.||
8004|176|R|Do not store in the bathroom. Keep all medications away from||
8004|177|R|children and pets.||
8004|178|R|   Do not flush medications down the toilet or pour them into a||
8004|179|R|drain unless instructed to do so. Properly discard this product||
8004|180|R|when it is expired or no longer needed. Consult your pharmacist||
8004|181|R|or local waste disposal company.||
8004|182|B|||
8004|183|A|Information last revised October 2025.||
8004|184|A|Copyright(c) 2025 First Databank, Inc.||
8004|185|B|||
8006|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8006|002|Z|does NOT have all possible information about this product. This||
8006|003|Z|information does not assure that this product is safe, effective,||
8006|004|Z|or appropriate for you. This information is not individual||
8006|005|Z|medical advice and does not substitute for the advice of your||
8006|006|Z|health care professional. Always ask your health care||
8006|007|Z|professional for complete information about this product and your||
8006|008|Z|specific health needs.||
8006|009|B|||
8006|010|T|MEPROBAMATE - ORAL||
8006|011|F|(meh-PRO-buh-mate)||
8006|012|B|||
8006|013|C|COMMON BRAND NAME(S): Equanil||
8006|014|B|||
8006|015|U|USES:  This medication is used short-term to treat symptoms of||
8006|016|U|anxiety and nervousness. It acts on certain centers of the brain||
8006|017|U|to help calm your nervous system.||
8006|018|B|||
8006|019|H|HOW TO USE:  Take this medication by mouth with or without food||
8006|020|H|as directed by your doctor, usually 2 to 4 times daily. The||
8006|021|H|dosage is based on your age, medical condition, and response to||
8006|022|H|treatment.||
8006|023|H|   Do not increase your dose or take this medication more often||
8006|024|H|than prescribed. Your condition will not improve any faster, and||
8006|025|H|the risk of serious side effects may be increased.||
8006|026|H|   If you suddenly stop using this medication, you may have||
8006|027|H|withdrawal symptoms (such as vomiting, shakiness, confusion, and||
8006|028|H|rarely seizures). To help prevent withdrawal, your doctor may||
8006|029|H|lower your dose slowly. Withdrawal is more likely if you have||
8006|030|H|used meprobamate for a long time or in high doses. Tell your||
8006|031|H|doctor or pharmacist right away if you have withdrawal.||
8006|032|H|   When this medication is used for a long time, it may not work||
8006|033|H|as well. Your doctor may need to increase your dose or change||
8006|034|H|your medication. Talk with your doctor if this medication stops||
8006|035|H|working well.||
8006|036|H|   Though it helps many people, this medication may sometimes||
8006|037|H|cause addiction. This risk may be higher if you have a substance||
8006|038|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
8006|039|H|Take this medication exactly as prescribed to lower the risk of||
8006|040|H|addiction. Ask your doctor or pharmacist for more details.||
8006|041|H|   Tell your doctor if your condition lasts or gets worse.||
8006|042|B|||
8006|043|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, excitement,||
8006|044|S|nausea, vomiting, and diarrhea may occur. If any of these effects||
8006|045|S|last or get worse, tell your doctor or pharmacist promptly.||
8006|046|S|   Remember that this medication has been prescribed because your||
8006|047|S|doctor has judged that the benefit to you is greater than the||
8006|048|S|risk of side effects. Many people using this medication do not||
8006|049|S|have serious side effects.||
8006|050|S|   Tell your doctor right away if you have any serious side||
8006|051|S|effects, including: numbness/tingling/swelling of arms/legs,||
8006|052|S|fast/irregular heartbeat, fainting, signs of infection (such as||
8006|053|S|sore throat that doesn't go away, fever, chills), easy||
8006|054|S|bruising/bleeding, signs of kidney problems (such as change in||
8006|055|S|the amount of urine), unusual tiredness.||
8006|056|S|   A very serious allergic reaction to this drug is rare.||
8006|057|S|However, get medical help right away if you notice any symptoms||
8006|058|S|of a serious allergic reaction, including: rash, itching/swelling||
8006|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8006|060|S|breathing.||
8006|061|S|   This is not a complete list of possible side effects. If you||
8006|062|S|notice other effects not listed above, contact your doctor or||
8006|063|S|pharmacist.||
8006|064|S|   In the US -||
8006|065|S|   Call your doctor for medical advice about side effects. You||
8006|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8006|067|S|www.fda.gov/medwatch.||
8006|068|S|   In Canada - Call your doctor for medical advice about side||
8006|069|S|effects. You may report side effects to Health Canada at||
8006|070|S|1-866-234-2345.||
8006|071|B|||
8006|072|P|PRECAUTIONS:  Before taking meprobamate, tell your doctor or||
8006|073|P|pharmacist if you are allergic to it; or to carisoprodol,||
8006|074|P|mebutamate, tybamate, or carbromal; or if you have any other||
8006|075|P|allergies. This product may contain inactive ingredients, which||
8006|076|P|can cause allergic reactions or other problems. Talk to your||
8006|077|P|pharmacist for more details.||
8006|078|P|   Before using this medication, tell your doctor or pharmacist||
8006|079|P|your medical history, especially of: a certain liver/blood||
8006|080|P|disorder (porphyria), kidney disease, liver disease, brain||
8006|081|P|disorders (such as seizures, brain damage), personal or family||
8006|082|P|history of a substance use disorder (such as overuse of or||
8006|083|P|addiction to drugs/alcohol).||
8006|084|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8006|085|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8006|086|P|machinery, or do anything that needs alertness until you can do||
8006|087|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
8006|088|P|are using marijuana (cannabis).||
8006|089|P|   Older adults may be more sensitive to the side effects of this||
8006|090|P|drug, especially drowsiness and addiction. Drowsiness can||
8006|091|P|increase the risk of falling.||
8006|092|P|   During pregnancy, this medication should be used only when||
8006|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
8006|094|P|   This medication passes into breast milk and may have||
8006|095|P|undesirable effects on a nursing infant. Consult your doctor||
8006|096|P|before breastfeeding.||
8006|097|B|||
8006|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8006|099|I|medications work or increase your risk for serious side effects.||
8006|100|I|This document does not contain all possible drug interactions.||
8006|101|I|Keep a list of all the products you use (including||
8006|102|I|prescription/nonprescription drugs and herbal products) and share||
8006|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
8006|104|I|the dosage of any medicines without your doctor's approval.||
8006|105|I|   A product that may interact with this drug is: sodium oxybate.||
8006|106|I|   Tell your doctor or pharmacist if you are using other products||
8006|107|I|that cause drowsiness such as opioid pain or cough relievers||
8006|108|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
8006|109|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
8006|110|I|zolpidem), muscle relaxants (such as carisoprodol,||
8006|111|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8006|112|I|diphenhydramine).||
8006|113|I|   Check the labels on all your medicines (such as allergy or||
8006|114|I|cough-and-cold products) because they may contain ingredients||
8006|115|I|that cause drowsiness. Ask your pharmacist about using those||
8006|116|I|products safely.||
8006|117|B|||
8006|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8006|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8006|120|O|poison control center right away. US residents can call||
8006|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8006|122|O|Symptoms of overdose may include: clumsiness, trouble speaking,||
8006|123|O|severe dizziness/drowsiness, or slow/shallow breathing.||
8006|124|B|||
8006|125|N|NOTES:  Do not share this medication with others. Sharing it is||
8006|126|N|against the law.||
8006|127|N|   Keep all medical and lab appointments.||
8006|128|B|||
8006|129|D|MISSED DOSE:  If you are taking this on a regular schedule and||
8006|130|D|you miss a dose, take it as soon as you remember. If it is near||
8006|131|D|the time of the next dose, skip the missed dose. Take your next||
8006|132|D|dose at the regular time. Do not double the dose to catch up.||
8006|133|B|||
8006|134|R|STORAGE:  Store at room temperature away from light and moisture.||
8006|135|R|Do not store in the bathroom. Keep all medications away from||
8006|136|R|children and pets.||
8006|137|R|   Do not flush medications down the toilet or pour them into a||
8006|138|R|drain unless instructed to do so. Properly discard this product||
8006|139|R|when it is expired or no longer needed. Consult your pharmacist||
8006|140|R|or local waste disposal company.||
8006|141|B|||
8006|142|A|Information last revised May 2025.||
8006|143|A|Copyright(c) 2025 First Databank, Inc.||
8006|144|B|||
8007|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8007|002|Z|does NOT have all possible information about this product. This||
8007|003|Z|information does not assure that this product is safe, effective,||
8007|004|Z|or appropriate for you. This information is not individual||
8007|005|Z|medical advice and does not substitute for the advice of your||
8007|006|Z|health care professional. Always ask your health care||
8007|007|Z|professional for complete information about this product and your||
8007|008|Z|specific health needs.||
8007|009|B|||
8007|010|T|NAFARELIN ACETATE SPRAY - NASAL||
8007|011|F|(NAF-a-REL-in AS-e-tate)||
8007|012|B|||
8007|013|C|COMMON BRAND NAME(S): Synarel||
8007|014|B|||
8007|015|U|USES:  Nafarelin is used in women to treat a condition in which||
8007|016|U|the tissue that normally lines the inside of the uterus grows in||
8007|017|U|the wrong place (endometriosis). This medication helps to||
8007|018|U|decrease the abnormal tissue and also the symptoms of||
8007|019|U|endometriosis (such as pelvic pain, painful menstrual cramps, and||
8007|020|U|pain during/after sex).||
8007|021|U|   This medication is also used by children to treat a certain||
8007|022|U|type of early puberty (central precocious puberty,||
8007|023|U|gonadotropin-dependent). It helps to slow the bone aging and||
8007|024|U|height growth rate so that both are near normal, and it helps to||
8007|025|U|stop or reverse signs of early puberty (such as breast growth in||
8007|026|U|girls, growth of sexual organs in boys).||
8007|027|U|   Nafarelin is similar to a natural hormone made by the body||
8007|028|U|(gonadotropin-releasing hormone-GnRH). It works by decreasing the||
8007|029|U|testosterone hormones in boys and estrogen hormones in women and||
8007|030|U|girls.||
8007|031|B|||
8007|032|H|HOW TO USE:  Read the Medication Guide and, if available, the||
8007|033|H|Patient Information Leaflet provided by your pharmacist before||
8007|034|H|you start using nafarelin and each time you get a refill. Follow||
8007|035|H|the illustrated directions for the proper use of this medication.||
8007|036|H|If you have any questions, ask your doctor or pharmacist.||
8007|037|H|   Follow the instructions for test sprays in the air if you are||
8007|038|H|using a bottle for the first time. A fine mist is a sign that the||
8007|039|H|spray is working properly.||
8007|040|H|   Gently blow your nose before using this drug. For very young||
8007|041|H|children, it may be necessary to clear the nose with a bulb||
8007|042|H|syringe.||
8007|043|H|   Use this medication as directed by your doctor, usually twice||
8007|044|H|daily (about every 12 hours). If you are using more than 1 spray||
8007|045|H|at a time, wait 30 seconds between each spray. Avoid spraying||
8007|046|H|this medication in your eyes. Also, avoid sneezing during or||
8007|047|H|right after using this medication because this may decrease the||
8007|048|H|amount of medication absorbed. Follow the detailed instructions||
8007|049|H|for cleaning the spray tip. It is important to clean the spray||
8007|050|H|tip after each use.||
8007|051|H|   The dosage and length of treatment are based on your medical||
8007|052|H|condition and response to treatment.||
8007|053|H|   It is very important to keep using this medication exactly as||
8007|054|H|prescribed by your doctor. Do not skip any doses. To help you||
8007|055|H|remember, use it at the same times each day.||
8007|056|H|   Ask your doctor or pharmacist to find out how long each bottle||
8007|057|H|of the nasal spray should last. Do not use the nasal spray bottle||
8007|058|H|longer, even if there is medication left over, because you will||
8007|059|H|not get a full dose. Make sure to get your medication refills a||
8007|060|H|few days early so that you will not run out of your medication.||
8007|061|H|   Do not increase your dose or use this drug more often or for||
8007|062|H|longer than prescribed. Your condition will not improve any||
8007|063|H|faster, and your risk of side effects will increase.||
8007|064|H|   If you need to use a nasal decongestant spray while using this||
8007|065|H|medication, wait at least 2 hours after using this medication||
8007|066|H|before using the decongestant.||
8007|067|H|   When you first start this medication, worsening of symptoms||
8007|068|H|may occur (such as increased vaginal bleeding for women treating||
8007|069|H|endometriosis, or vaginal bleeding/period, increase in breast||
8007|070|H|size/pubic hair, oily skin, or body odor for children treating||
8007|071|H|early puberty). These symptoms should get better after the first||
8007|072|H|month of treatment. Tell your doctor if your symptoms do not get||
8007|073|H|better or if they get worse after 2 months of treatment.||
8007|074|B|||
8007|075|S|SIDE EFFECTS:  Nasal irritation, hot flashes, or vaginal||
8007|076|S|discharge may occur in children. Nasal irritation, hot flashes,||
8007|077|S|headaches, decreased sexual interest, muscle pain, vaginal||
8007|078|S|dryness, acne, or decrease in breast size may occur in women. If||
8007|079|S|any of these effects last or get worse, tell the doctor or||
8007|080|S|pharmacist promptly.||
8007|081|S|   Remember that this medication has been prescribed because your||
8007|082|S|doctor has judged that the benefit to you is greater than the||
8007|083|S|risk of side effects. Many people using this medication do not||
8007|084|S|have serious side effects.||
8007|085|S|   Tell the doctor right away if any of these serious side||
8007|086|S|effects occur: mental/mood changes (such as depression, thoughts||
8007|087|S|of suicide, mood swings, aggression).||
8007|088|S|   For women using this medication, tell your doctor right away||
8007|089|S|if you have any serious side effects, including: abdominal/lower||
8007|090|S|back pain, bone pain, fast/pounding heartbeat, numbness/tingling||
8007|091|S|of arms/legs, eye pain.||
8007|092|S|   Get medical help right away if any of these very serious side||
8007|093|S|effects occur: seizures.||
8007|094|S|   Children using nafarelin may be at risk for increased pressure||
8007|095|S|around the brain (intracranial hypertension). Get medical help||
8007|096|S|right away if your child has any of these very serious side||
8007|097|S|effects: nausea/vomiting that doesn't stop, headache that is||
8007|098|S|severe or doesn't go away, eye pain, vision changes (such as||
8007|099|S|blurred/double vision, decreased vision), ringing in the ears.||
8007|100|S|   A very serious allergic reaction to this drug is rare.||
8007|101|S|However, get medical help right away if you notice any symptoms||
8007|102|S|of a serious allergic reaction, including: fever, swollen lymph||
8007|103|S|nodes, rash, itching/swelling (especially of the||
8007|104|S|face/tongue/throat), severe dizziness, trouble breathing.||
8007|105|S|   This is not a complete list of possible side effects. If you||
8007|106|S|notice other effects not listed above, contact your doctor or||
8007|107|S|pharmacist.||
8007|108|S|   In the US -||
8007|109|S|   Call your doctor for medical advice about side effects. You||
8007|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8007|111|S|www.fda.gov/medwatch.||
8007|112|S|   In Canada - Call your doctor for medical advice about side||
8007|113|S|effects. You may report side effects to Health Canada at||
8007|114|S|1-866-234-2345.||
8007|115|B|||
8007|116|P|PRECAUTIONS:  Before using nafarelin, tell your doctor or||
8007|117|P|pharmacist if you are allergic to it; or to GnRH or other||
8007|118|P|GnRH-like hormones (such as leuprolide); or if you have any other||
8007|119|P|allergies. This product may contain inactive ingredients, which||
8007|120|P|can cause allergic reactions or other problems. Talk to your||
8007|121|P|pharmacist for more details.||
8007|122|P|   Before using this medication, tell your doctor or pharmacist||
8007|123|P|your medical history, especially of: unexplained abnormal vaginal||
8007|124|P|bleeding, smoking, daily alcohol use, bone loss (osteoporosis) or||
8007|125|P|family history of osteoporosis, polycystic ovarian disease, high||
8007|126|P|cholesterol/triglyceride levels, seizures, mental/mood problems||
8007|127|P|(such as depression).||
8007|128|P|   Before having surgery, tell your doctor or dentist about all||
8007|129|P|the products you use (including prescription drugs,||
8007|130|P|nonprescription drugs, and herbal products).||
8007|131|P|   This medication must not be used during pregnancy. It may harm||
8007|132|P|an unborn baby. Women should start this medication between days 2||
8007|133|P|and 4 of their period. Although periods and the release of eggs||
8007|134|P|(ovulation) may stop while you are using this drug, this is not a||
8007|135|P|reliable form of birth control. Discuss the use of non-hormonal||
8007|136|P|forms of birth control (such as condoms, diaphragm with||
8007|137|P|spermicide) with your doctor. If you become pregnant or think you||
8007|138|P|may be pregnant, tell your doctor right away.||
8007|139|P|   It is unknown if this medication passes into breast milk.||
8007|140|P|Because of the possible risk to the infant, breastfeeding is not||
8007|141|P|recommended while using this medication. Consult your doctor||
8007|142|P|before breastfeeding.||
8007|143|B|||
8007|144|I|DRUG INTERACTIONS:  See also How to Use section.||
8007|145|I|   Drug interactions may change how your medications work or||
8007|146|I|increase your risk for serious side effects. This document does||
8007|147|I|not contain all possible drug interactions. Keep a list of all||
8007|148|I|the products you use (including prescription/nonprescription||
8007|149|I|drugs and herbal products) and share it with your doctor and||
8007|150|I|pharmacist. Do not start, stop, or change the dosage of any||
8007|151|I|medicines without your doctor's approval.||
8007|152|I|   This medication may interfere with certain lab tests (such as||
8007|153|I|tests for pituitary gonadotropic and gonadal functions), possibly||
8007|154|I|causing false test results. Make sure lab personnel and all your||
8007|155|I|doctors know you use this drug.||
8007|156|B|||
8007|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8007|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8007|159|O|poison control center right away. US residents can call||
8007|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8007|161|B|||
8007|162|N|NOTES:  Do not share this medication with others.||
8007|163|N|   Lab and/or medical tests (such as growth/bone age velocity in||
8007|164|N|children) should be done while you are using this medication.||
8007|165|N|Keep all medical and lab appointments. Consult your doctor for||
8007|166|N|more details.||
8007|167|B|||
8007|168|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8007|169|D|If it is near the time of the next dose, skip the missed dose.||
8007|170|D|Use your next dose at the regular time. Do not double the dose to||
8007|171|D|catch up.||
8007|172|D|   Vaginal bleeding may occur in girls/women who miss doses of||
8007|173|D|this medication.||
8007|174|B|||
8007|175|R|STORAGE:  Store the bottle upright at room temperature away from||
8007|176|R|light. Do not freeze. Keep all medications away from children and||
8007|177|R|pets.||
8007|178|R|   Do not flush medications down the toilet or pour them into a||
8007|179|R|drain unless instructed to do so. Properly discard this product||
8007|180|R|when it is expired or no longer needed. Consult your pharmacist||
8007|181|R|or local waste disposal company.||
8007|182|B|||
8007|183|A|Information last revised September 2025.||
8007|184|A|Copyright(c) 2025 First Databank, Inc.||
8007|185|B|||
8008|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8008|002|Z|does NOT have all possible information about this product. This||
8008|003|Z|information does not assure that this product is safe, effective,||
8008|004|Z|or appropriate for you. This information is not individual||
8008|005|Z|medical advice and does not substitute for the advice of your||
8008|006|Z|health care professional. Always ask your health care||
8008|007|Z|professional for complete information about this product and your||
8008|008|Z|specific health needs.||
8008|009|B|||
8008|010|T|IPRATROPIUM HFA INHALER - ORAL INHALATION||
8008|011|F|(IP-ra-TROE-pee-um)||
8008|012|B|||
8008|013|C|COMMON BRAND NAME(S): Atrovent||
8008|014|B|||
8008|015|U|USES:  Ipratropium is used to control and prevent symptoms||
8008|016|U|(wheezing and shortness of breath) caused by ongoing lung disease||
8008|017|U|(chronic obstructive pulmonary disease-COPD which includes||
8008|018|U|bronchitis and emphysema). It works by relaxing the muscles||
8008|019|U|around the airways so that they open up and you can breathe more||
8008|020|U|easily. Controlling symptoms of breathing problems can decrease||
8008|021|U|time lost from work or school.||
8008|022|U|   For preventing symptoms of lung disease, this medication must||
8008|023|U|be used regularly to be effective. Use your quick-relief inhaler||
8008|024|U|(such as albuterol, also called salbutamol in some countries) for||
8008|025|U|wheezing or sudden shortness of breath unless otherwise directed||
8008|026|U|by your doctor. Ipratropium does not work as fast as your||
8008|027|U|quick-relief inhaler, but may sometimes be used to relieve||
8008|028|U|symptoms of wheezing or sudden shortness of breath if so||
8008|029|U|prescribed by your doctor.||
8008|030|B|||
8008|031|V|OTHER USES:  This section contains uses of this drug that are not||
8008|032|V|listed in the approved professional labeling for the drug but||
8008|033|V|that may be prescribed by your health care professional. Use this||
8008|034|V|drug for a condition that is listed in this section only if it||
8008|035|V|has been so prescribed by your health care professional.||
8008|036|V|   This drug may also be used to control symptoms (such as||
8008|037|V|wheezing and sudden shortness of breath) caused by asthma.||
8008|038|B|||
8008|039|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8008|040|H|from your pharmacist before you start using ipratropium and each||
8008|041|H|time you get a refill. Learn how to use this inhaler properly. If||
8008|042|H|you have any questions, ask your doctor or pharmacist.||
8008|043|H|   Follow the instructions for priming the inhaler if you are||
8008|044|H|using it for the first time or if you have not used it for more||
8008|045|H|than 3 days. When priming the inhaler, make sure to spray away||
8008|046|H|from the face so that you do not get the medication into your||
8008|047|H|eyes.||
8008|048|H|   Inhale this medication by mouth as directed by your doctor,||
8008|049|H|usually 4 times a day. Avoid getting this medication into your||
8008|050|H|eyes. It may cause eye pain/irritation, temporary blurred vision,||
8008|051|H|and other vision changes. When using the inhaler, put your lips||
8008|052|H|tightly around the mouthpiece and keep your eyes closed.||
8008|053|H|   If your prescribed dose is 2 puffs, wait at least one minute||
8008|054|H|between them. If you are using other inhalers at the same time,||
8008|055|H|wait at least 1 minute between the use of each medication.||
8008|056|H|   Rinse your mouth after using the inhaler to prevent dry mouth||
8008|057|H|and throat irritation.||
8008|058|H|   Dosage is based on your medical condition and response to||
8008|059|H|treatment.||
8008|060|H|   Clean the mouthpiece of the inhaler once a week with water.||
8008|061|H|Allow to air-dry fully before using again.||
8008|062|H|   If you are directed to use this medication regularly, it works||
8008|063|H|best if used at evenly spaced intervals. To help you remember,||
8008|064|H|use it at the same times each day. Do not increase your dose, use||
8008|065|H|this medication more often, or stop using it without first||
8008|066|H|consulting your doctor.||
8008|067|H|   Keep track of the number of inhalations you use, and throw||
8008|068|H|away the canister after you have used the labeled number of||
8008|069|H|inhalations on the package.||
8008|070|H|   Tell your doctor if your symptoms do not get better or if they||
8008|071|H|get worse.||
8008|072|H|   Learn which of your inhalers you should use every day||
8008|073|H|(controller drugs) and which you should use if your breathing||
8008|074|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
8008|075|H|time what you should do if you have new or worsening cough or||
8008|076|H|shortness of breath, wheezing, increased sputum, worsening peak||
8008|077|H|flow meter readings, waking up at night with trouble breathing,||
8008|078|H|if you use your quick-relief inhaler more often (more than 2 days||
8008|079|H|a week), or if your quick-relief inhaler does not seem to be||
8008|080|H|working well. Learn when you can treat sudden breathing problems||
8008|081|H|by yourself and when you must get medical help right away.||
8008|082|B|||
8008|083|S|SIDE EFFECTS:  See also How to Use section.||
8008|084|S|   Dizziness, nausea, stomach upset, dry mouth, or constipation||
8008|085|S|may occur. If any of these effects last or get worse, tell your||
8008|086|S|doctor or pharmacist promptly.||
8008|087|S|   Remember that this medication has been prescribed because your||
8008|088|S|doctor has judged that the benefit to you is greater than the||
8008|089|S|risk of side effects. Many people using this medication do not||
8008|090|S|have serious side effects.||
8008|091|S|   Rarely, this medication may cause severe sudden worsening of||
8008|092|S|breathing problems right after use. If you have sudden worsening||
8008|093|S|of breathing, use your quick-relief inhaler and get medical help||
8008|094|S|right away.||
8008|095|S|   Tell your doctor right away if you have any serious side||
8008|096|S|effects, including: fast/pounding heartbeat, difficult/painful||
8008|097|S|urination.||
8008|098|S|   Get medical help right away if you have any very serious side||
8008|099|S|effects, including: eye pain/swelling/redness, vision changes||
8008|100|S|(such as seeing rainbows around lights at night, blurred vision).||
8008|101|S|   A very serious allergic reaction to this product is rare.||
8008|102|S|However, get medical help right away if you notice any symptoms||
8008|103|S|of a serious allergic reaction, including: rash, itching/swelling||
8008|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8008|105|S|breathing.||
8008|106|S|   This is not a complete list of possible side effects. If you||
8008|107|S|notice other effects not listed above, contact your doctor or||
8008|108|S|pharmacist.||
8008|109|S|   In the US -||
8008|110|S|   Call your doctor for medical advice about side effects. You||
8008|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8008|112|S|www.fda.gov/medwatch.||
8008|113|S|   In Canada - Call your doctor for medical advice about side||
8008|114|S|effects. You may report side effects to Health Canada at||
8008|115|S|1-866-234-2345.||
8008|116|B|||
8008|117|P|PRECAUTIONS:  Before using ipratropium, tell your doctor or||
8008|118|P|pharmacist if you are allergic to it or tiotropium; or to||
8008|119|P|atropine or other belladonna-type drugs; or if you have any other||
8008|120|P|allergies. This product may contain inactive ingredients, which||
8008|121|P|can cause allergic reactions or other problems. Talk to your||
8008|122|P|pharmacist for more details.||
8008|123|P|   Before using this medication, tell your doctor or pharmacist||
8008|124|P|your medical history, especially of: personal or family history||
8008|125|P|of glaucoma (angle-closure type), difficulty urinating (for||
8008|126|P|example, due to enlarged prostate).||
8008|127|P|   This drug may make you dizzy or blur your vision or cause||
8008|128|P|vision changes. Alcohol or marijuana (cannabis) can make you more||
8008|129|P|dizzy. Do not drive, use machinery, or do anything that needs||
8008|130|P|alertness or clear vision until you can do it safely. Limit||
8008|131|P|alcoholic beverages. Talk to your doctor if you are using||
8008|132|P|marijuana (cannabis).||
8008|133|P|   Before having surgery, tell your doctor or dentist about all||
8008|134|P|the products you use (including prescription drugs,||
8008|135|P|nonprescription drugs, and herbal products).||
8008|136|P|   Older adults may be more sensitive to the side effects of this||
8008|137|P|drug, especially problems urinating or constipation.||
8008|138|P|   During pregnancy, this medication should be used only when||
8008|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
8008|140|P|   It is unknown if this medication passes into breast milk.||
8008|141|P|Consult your doctor before breastfeeding.||
8008|142|B|||
8008|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8008|144|I|medications work or increase your risk for serious side effects.||
8008|145|I|This document does not contain all possible drug interactions.||
8008|146|I|Keep a list of all the products you use (including||
8008|147|I|prescription/nonprescription drugs and herbal products) and share||
8008|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
8008|149|I|the dosage of any medicines without your doctor's approval.||
8008|150|B|||
8008|151|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8008|152|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8008|153|O|poison control center right away. US residents can call||
8008|154|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8008|155|B|||
8008|156|N|NOTES:  Do not share this medication with others.||
8008|157|B|||
8008|158|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8008|159|D|If it is near the time of the next dose, skip the missed dose.||
8008|160|D|Use your next dose at the regular time. Do not double the dose to||
8008|161|D|catch up.||
8008|162|B|||
8008|163|R|STORAGE:  Store at room temperature. Do not puncture the canister||
8008|164|R|or use near an open flame. Keep all medications away from||
8008|165|R|children and pets.||
8008|166|R|   Do not flush medications down the toilet or pour them into a||
8008|167|R|drain unless instructed to do so. Properly discard this product||
8008|168|R|when it is expired or no longer needed. Consult your pharmacist||
8008|169|R|or local waste disposal company.||
8008|170|B|||
8008|171|M|MEDICAL ALERT:  Your condition can cause complications in a||
8008|172|M|medical emergency. For information about enrolling in MedicAlert,||
8008|173|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8008|174|B|||
8008|175|A|Information last revised October 2024.||
8008|176|A|Copyright(c) 2025 First Databank, Inc.||
8008|177|B|||
8011|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8011|002|Z|does NOT have all possible information about this product. This||
8011|003|Z|information does not assure that this product is safe, effective,||
8011|004|Z|or appropriate for you. This information is not individual||
8011|005|Z|medical advice and does not substitute for the advice of your||
8011|006|Z|health care professional. Always ask your health care||
8011|007|Z|professional for complete information about this product and your||
8011|008|Z|specific health needs.||
8011|009|B|||
8011|010|T|CEFUROXIME - ORAL||
8011|011|F|(seff-you-ROX-eem)||
8011|012|B|||
8011|013|C|COMMON BRAND NAME(S): Ceftin||
8011|014|B|||
8011|015|U|USES:  Cefuroxime is used to treat a wide variety of bacterial||
8011|016|U|infections. This medication is known as a cephalosporin||
8011|017|U|antibiotic. It works by stopping the growth of bacteria.||
8011|018|U|   This antibiotic treats only bacterial infections. It will not||
8011|019|U|work for viral infections (such as common cold, flu). Using any||
8011|020|U|antibiotic when it is not needed can cause it to not work for||
8011|021|U|future infections.||
8011|022|B|||
8011|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
8011|024|H|doctor, usually twice daily (every 12 hours). Take cefuroxime||
8011|025|H|with food to increase absorption and reduce stomach upset. The||
8011|026|H|dosage is based on your medical condition and response to||
8011|027|H|treatment.||
8011|028|H|   Swallow the tablets whole. Do not crush or chew because the||
8011|029|H|tablets have a strong bitter taste. Use the liquid suspension||
8011|030|H|form of this medication if it is difficult to swallow the||
8011|031|H|tablets.||
8011|032|H|   For the best effect, take this antibiotic at evenly spaced||
8011|033|H|times. To help you remember, take this medication at the same||
8011|034|H|time(s) every day.||
8011|035|H|   Continue to take this medication until the full prescribed||
8011|036|H|amount is finished, even if symptoms disappear after a few days.||
8011|037|H|Stopping the medication too early may result in a return of the||
8011|038|H|infection.||
8011|039|H|   Tell your doctor if your condition lasts or gets worse.||
8011|040|B|||
8011|041|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, or stomach pain may||
8011|042|S|occur. Dizziness and drowsiness may occur less often, especially||
8011|043|S|with higher doses. If any of these effects last or get worse,||
8011|044|S|tell your doctor or pharmacist promptly.||
8011|045|S|   Remember that this medication has been prescribed because your||
8011|046|S|doctor has judged that the benefit to you is greater than the||
8011|047|S|risk of side effects. Many people using this medication do not||
8011|048|S|have serious side effects.||
8011|049|S|   Tell your doctor right away if you have any serious side||
8011|050|S|effects, including: unusual tiredness/weakness, signs of liver||
8011|051|S|problems (such as nausea/vomiting that doesn't stop,||
8011|052|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
8011|053|S|of kidney problems (such as change in the amount of urine), signs||
8011|054|S|of new infection (such as sore throat that doesn't go away,||
8011|055|S|fever), easy bruising/bleeding, jerky movements, mental/mood||
8011|056|S|changes (such as confusion).||
8011|057|S|   This medication may rarely cause a severe intestinal condition||
8011|058|S|due to a bacteria called C. difficile. This condition may occur||
8011|059|S|during treatment or weeks to months after treatment has stopped.||
8011|060|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8011|061|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8011|062|S|stool.||
8011|063|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8011|064|S|products because they may make symptoms worse.||
8011|065|S|   Use of this medication for prolonged or repeated periods may||
8011|066|S|result in oral thrush or a new vaginal yeast infection (oral or||
8011|067|S|vaginal fungal infection). Contact your doctor if you notice||
8011|068|S|white patches in your mouth, a change in vaginal discharge or||
8011|069|S|other new symptoms.||
8011|070|S|   A very serious allergic reaction to this drug is rare.||
8011|071|S|However, get medical help right away if you notice any symptoms||
8011|072|S|of a serious allergic reaction, including: rash, itching/swelling||
8011|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8011|074|S|breathing.||
8011|075|S|   This is not a complete list of possible side effects. If you||
8011|076|S|notice other effects not listed above, contact your doctor or||
8011|077|S|pharmacist.||
8011|078|S|   In the US -||
8011|079|S|   Call your doctor for medical advice about side effects. You||
8011|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8011|081|S|www.fda.gov/medwatch.||
8011|082|S|   In Canada - Call your doctor for medical advice about side||
8011|083|S|effects. You may report side effects to Health Canada at||
8011|084|S|1-866-234-2345.||
8011|085|B|||
8011|086|P|PRECAUTIONS:  Before taking cefuroxime, tell your doctor or||
8011|087|P|pharmacist if you are allergic to it; or to penicillins or other||
8011|088|P|cephalosporin antibiotics (such as cephalexin); or if you have||
8011|089|P|any other allergies. This product may contain inactive||
8011|090|P|ingredients, which can cause allergic reactions or other||
8011|091|P|problems. Talk to your pharmacist for more details.||
8011|092|P|   Before using this medication, tell your doctor or pharmacist||
8011|093|P|your medical history, especially of: kidney disease, intestinal||
8011|094|P|disease (colitis), liver disease, poor nutrition.||
8011|095|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8011|096|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8011|097|P|machinery, or do anything that needs alertness until you can do||
8011|098|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8011|099|P|are using marijuana (cannabis).||
8011|100|P|   Cefuroxime may cause live bacterial vaccines (such as typhoid||
8011|101|P|vaccine) to not work well. Tell your health care professional||
8011|102|P|that you are using cefuroxime before having any||
8011|103|P|immunizations/vaccinations.||
8011|104|P|   Before having surgery, tell your doctor or dentist about all||
8011|105|P|the products you use (including prescription drugs,||
8011|106|P|nonprescription drugs, and herbal products).||
8011|107|P|   Older adults may be more sensitive to the side effects of this||
8011|108|P|drug.||
8011|109|P|   During pregnancy, this medication should be used only when||
8011|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
8011|111|P|   This medication passes into breast milk. Consult your doctor||
8011|112|P|before breastfeeding.||
8011|113|B|||
8011|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8011|115|I|medications work or increase your risk for serious side effects.||
8011|116|I|This document does not contain all possible drug interactions.||
8011|117|I|Keep a list of all the products you use (including||
8011|118|I|prescription/nonprescription drugs and herbal products) and share||
8011|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
8011|120|I|the dosage of any medicines without your doctor's approval.||
8011|121|I|   This medication may interfere with certain lab tests (such as||
8011|122|I|certain diabetic urine tests, blood glucose tests), possibly||
8011|123|I|causing false test results. Make sure lab personnel and all your||
8011|124|I|doctors know you use this drug.||
8011|125|B|||
8011|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8011|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8011|128|O|poison control center right away. US residents can call||
8011|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8011|130|O|Symptoms of overdose may include seizures.||
8011|131|B|||
8011|132|N|NOTES:  Do not share this medication with others.||
8011|133|N|   This medication has been prescribed for your current condition||
8011|134|N|only. Do not use it later for another infection unless your||
8011|135|N|doctor tells you to.||
8011|136|B|||
8011|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8011|138|D|remember. If it is near the time of the next dose, skip the||
8011|139|D|missed dose. Take your next dose at the regular time. Do not||
8011|140|D|double the dose to catch up.||
8011|141|B|||
8011|142|R|STORAGE:  Store at room temperature away from light and moisture.||
8011|143|R|Do not store in the bathroom. Keep all medications away from||
8011|144|R|children and pets.||
8011|145|R|   Do not flush medications down the toilet or pour them into a||
8011|146|R|drain unless instructed to do so. Properly discard this product||
8011|147|R|when it is expired or no longer needed. Consult your pharmacist||
8011|148|R|or local waste disposal company.||
8011|149|B|||
8011|150|A|Information last revised May 2024.||
8011|151|A|Copyright(c) 2025 First Databank, Inc.||
8011|152|B|||
8013|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8013|002|Z|does NOT have all possible information about this product. This||
8013|003|Z|information does not assure that this product is safe, effective,||
8013|004|Z|or appropriate for you. This information is not individual||
8013|005|Z|medical advice and does not substitute for the advice of your||
8013|006|Z|health care professional. Always ask your health care||
8013|007|Z|professional for complete information about this product and your||
8013|008|Z|specific health needs.||
8013|009|B|||
8013|010|T|BETAXOLOL SOLUTION - OPHTHALMIC||
8013|011|F|(be-TAX-oh-lol)||
8013|012|B|||
8013|013|C|COMMON BRAND NAME(S): Betoptic||
8013|014|B|||
8013|015|U|USES:  This medication is used alone or with other medications to||
8013|016|U|treat high pressure inside the eye due to glaucoma (open-angle||
8013|017|U|type) or other eye diseases (such as ocular hypertension).||
8013|018|U|Lowering high pressure inside the eye helps to prevent blindness.||
8013|019|U|Betaxolol belongs to a class of drugs known as beta blockers and||
8013|020|U|works by decreasing the amount of fluid that is made within the||
8013|021|U|eye.||
8013|022|B|||
8013|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
8013|024|H|directed by your doctor, usually twice daily.||
8013|025|H|   To apply eye drops, wash your hands first. To avoid||
8013|026|H|contamination, do not touch the dropper tip or let it touch your||
8013|027|H|eye or any other surface.||
8013|028|H|   If you are wearing contact lenses, remove them before using||
8013|029|H|eye drops. Wait at least 15 minutes before replacing your contact||
8013|030|H|lenses.||
8013|031|H|   Tilt your head back, look upward, and pull down the lower||
8013|032|H|eyelid to make a pouch. Hold the dropper directly over your eye||
8013|033|H|and place one drop into the pouch. Look downward and gently close||
8013|034|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
8013|035|H|your eye (near the nose) and apply gentle pressure. This will||
8013|036|H|prevent the medication from draining out. Try not to blink and do||
8013|037|H|not rub your eye. Repeat these steps for your other eye if so||
8013|038|H|directed or if your dose is for more than 1 drop.||
8013|039|H|   Do not rinse the dropper. Replace the dropper cap after each||
8013|040|H|use.||
8013|041|H|   If you are using another kind of eye medication (such as drops||
8013|042|H|or ointments), wait at least 10 minutes before using the other||
8013|043|H|medications. Use eye drops before eye ointments to allow the eye||
8013|044|H|drops to enter the eye.||
8013|045|H|   Wait several minutes for your vision to clear before driving||
8013|046|H|or operating machinery.||
8013|047|H|   Use this medication regularly in order to get the most benefit||
8013|048|H|from it. To help you remember, use it at the same time(s) each||
8013|049|H|day. Keep using this medication even if you feel well. Most||
8013|050|H|people with glaucoma or high pressure in the eyes do not feel||
8013|051|H|sick.||
8013|052|B|||
8013|053|S|SIDE EFFECTS:  Temporary stinging/discomfort of the eye,||
8013|054|S|watery/dry/itchy/red eyes, blurred vision, feeling as if||
8013|055|S|something is in the eye, headache, trouble sleeping, or dizziness||
8013|056|S|may occur. If any of these effects last or get worse, tell your||
8013|057|S|doctor or pharmacist promptly.||
8013|058|S|   Remember that this medication has been prescribed because your||
8013|059|S|doctor has judged that the benefit to you is greater than the||
8013|060|S|risk of side effects. Many people using this medication do not||
8013|061|S|have serious side effects.||
8013|062|S|   Tell your doctor right away if you have any serious side||
8013|063|S|effects, including: eye pain/swelling/discharge, vision changes,||
8013|064|S|increased eye sensitivity to light, swelling of the ankles/feet,||
8013|065|S|tiredness, slow/irregular heartbeat, muscle weakness, mental/mood||
8013|066|S|changes, hair loss, blue fingers/toes, cold hands/feet.||
8013|067|S|   Get medical help right away if you have any very serious side||
8013|068|S|effects, including: trouble breathing, sudden unexplained weight||
8013|069|S|gain, chest pain, weakness on one side of the body, trouble||
8013|070|S|speaking, confusion, severe dizziness, fainting.||
8013|071|S|   A very serious allergic reaction to this drug is rare.||
8013|072|S|However, get medical help right away if you notice any symptoms||
8013|073|S|of a serious allergic reaction, including: rash, itching/swelling||
8013|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8013|075|S|breathing.||
8013|076|S|   This is not a complete list of possible side effects. If you||
8013|077|S|notice other effects not listed above, contact your doctor or||
8013|078|S|pharmacist.||
8013|079|S|   In the US -||
8013|080|S|   Call your doctor for medical advice about side effects. You||
8013|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8013|082|S|www.fda.gov/medwatch.||
8013|083|S|   In Canada - Call your doctor for medical advice about side||
8013|084|S|effects. You may report side effects to Health Canada at||
8013|085|S|1-866-234-2345.||
8013|086|B|||
8013|087|P|PRECAUTIONS:  Before using betaxolol, tell your doctor or||
8013|088|P|pharmacist if you are allergic to it; or to other beta blockers||
8013|089|P|(such as timolol, metipranolol); or if you have any other||
8013|090|P|allergies. This product may contain inactive ingredients (such as||
8013|091|P|preservatives like benzalkonium chloride), which can cause||
8013|092|P|allergic reactions or other problems. Talk to your pharmacist for||
8013|093|P|more details.||
8013|094|P|   Before using this medication, tell your doctor or pharmacist||
8013|095|P|your medical history, especially of: diabetes, low blood sugar||
8013|096|P|levels (hypoglycemia), overactive thyroid (hyperthyroidism),||
8013|097|P|muscle weakness disorders (such as myasthenia gravis), breathing||
8013|098|P|problems (such as asthma, chronic obstructive pulmonary||
8013|099|P|disease-COPD), heart problems (such as heart failure, slow||
8013|100|P|heartbeat, second- or third-degree atrioventricular block), low||
8013|101|P|blood flow to the brain (cerebrovascular insufficiency), poor||
8013|102|P|blood flow to the hands/feet (Raynaud's phenomenon), severe||
8013|103|P|allergies.||
8013|104|P|   If you develop an eye infection or injury, or have eye||
8013|105|P|surgery, check with your doctor about whether you should continue||
8013|106|P|to use your current bottle of betaxolol. You may be advised to||
8013|107|P|start using a new bottle.||
8013|108|P|   Before having surgery, tell your doctor or dentist about all||
8013|109|P|the products you use (including prescription drugs,||
8013|110|P|nonprescription drugs, and herbal products).||
8013|111|P|   This drug may make you dizzy or temporarily blur your vision.||
8013|112|P|Do not drive, use machinery, or do anything that needs alertness||
8013|113|P|or clear vision until you can do it safely. Limit alcoholic||
8013|114|P|beverages. Talk to your doctor if you are using marijuana||
8013|115|P|(cannabis).||
8013|116|P|   This product may prevent the fast/pounding heartbeat you would||
8013|117|P|usually feel when your blood sugar level falls too low||
8013|118|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
8013|119|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
8013|120|P|blood sugar level, such as dizziness and sweating, are not||
8013|121|P|affected by this drug.||
8013|122|P|   If you have diabetes, this product may make it harder to||
8013|123|P|control your blood sugar levels. Check your blood sugar levels||
8013|124|P|regularly as directed by your doctor. Tell your doctor right away||
8013|125|P|if you have symptoms of high blood sugar such as increased||
8013|126|P|thirst/urination. Your doctor may need to adjust your diabetes||
8013|127|P|medication, exercise program, or diet.||
8013|128|P|   During pregnancy, this medication should be used only when||
8013|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
8013|130|P|   It is unknown if this medication passes into breast milk.||
8013|131|P|Consult your doctor before breastfeeding.||
8013|132|B|||
8013|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8013|134|I|medications work or increase your risk for serious side effects.||
8013|135|I|This document does not contain all possible drug interactions.||
8013|136|I|Keep a list of all the products you use (including||
8013|137|I|prescription/nonprescription drugs and herbal products) and share||
8013|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
8013|139|I|the dosage of any medicines without your doctor's approval.||
8013|140|I|   Some products that may interact with this drug are: drugs for||
8013|141|I|high blood pressure (including clonidine, oral beta blockers such||
8013|142|I|as propranolol, calcium channel blockers such as diltiazem),||
8013|143|I|epinephrine.||
8013|144|B|||
8013|145|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8013|146|O|has overdosed and has serious symptoms such as passing out or||
8013|147|O|trouble breathing, call 911. Otherwise, call a poison control||
8013|148|O|center right away. US residents can call 1-800-222-1222. Canada||
8013|149|O|residents can call 1-844-764-7669. If accidentally swallowed, you||
8013|150|O|may experience symptoms such as trouble breathing, slow/irregular||
8013|151|O|heartbeat.||
8013|152|B|||
8013|153|N|NOTES:  Do not share this medication with others.||
8013|154|N|   Lab and/or medical tests (such as eye exams) should be done||
8013|155|N|while you are using this medication. Keep all medical and lab||
8013|156|N|appointments. Consult your doctor for more details.||
8013|157|B|||
8013|158|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8013|159|D|If it is near the time of the next dose, skip the missed dose.||
8013|160|D|Use your next dose at the regular time. Do not double the dose to||
8013|161|D|catch up.||
8013|162|B|||
8013|163|R|STORAGE:  Store at room temperature. Keep all medications away||
8013|164|R|from children and pets.||
8013|165|R|   Do not flush medications down the toilet or pour them into a||
8013|166|R|drain unless instructed to do so. Properly discard this product||
8013|167|R|when it is expired or no longer needed. Consult your pharmacist||
8013|168|R|or local waste disposal company.||
8013|169|B|||
8013|170|A|Information last revised May 2024.||
8013|171|A|Copyright(c) 2025 First Databank, Inc.||
8013|172|B|||
8016|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8016|002|Z|does NOT have all possible information about this product. This||
8016|003|Z|information does not assure that this product is safe, effective,||
8016|004|Z|or appropriate for you. This information is not individual||
8016|005|Z|medical advice and does not substitute for the advice of your||
8016|006|Z|health care professional. Always ask your health care||
8016|007|Z|professional for complete information about this product and your||
8016|008|Z|specific health needs.||
8016|009|B|||
8016|010|T|CLINDAMYCIN - INJECTION||
8016|011|F|(KLIN-da-MYE-sin)||
8016|012|B|||
8016|013|C|COMMON BRAND NAME(S): Cleocin||
8016|014|B|||
8016|015|W|WARNING:  This medication may rarely cause a severe intestinal||
8016|016|W|condition due to a bacteria called C. difficile. This condition||
8016|017|W|may occur weeks to months after treatment has stopped. Tell your||
8016|018|W|doctor right away if you develop: diarrhea that doesn't stop,||
8016|019|W|abdominal or stomach pain/cramping, blood/mucus in your stool. If||
8016|020|W|you have these symptoms, do not use anti-diarrhea or opioid||
8016|021|W|products because they may make symptoms worse.||
8016|022|B|||
8016|023|U|USES:  This medication is used to treat a wide variety of||
8016|024|U|bacterial infections. It works by stopping the growth of||
8016|025|U|bacteria.||
8016|026|U|   This medication should not be used to treat meningitis.||
8016|027|B|||
8016|028|H|HOW TO USE:  This medication is given by injection into a vein or||
8016|029|H|muscle as directed by your doctor, usually 2 to 4 times a day.||
8016|030|H|The dosage is based on your medical condition and response to||
8016|031|H|treatment. Children's dosage is also based on weight.||
8016|032|H|   If you are giving this medication to yourself at home, learn||
8016|033|H|all preparation and usage instructions from your health care||
8016|034|H|professional. Before using, check this product for particles or||
8016|035|H|discoloration. If either is present, do not use the liquid. Learn||
8016|036|H|how to store and discard medical supplies safely.||
8016|037|H|   Antibiotics work best when the amount of medicine in your body||
8016|038|H|is kept at a constant level. Use this drug at evenly spaced||
8016|039|H|intervals.||
8016|040|H|   Continue to use this medication until the full prescribed||
8016|041|H|amount is finished, even if symptoms disappear after a few days.||
8016|042|H|Stopping the medication too early may result in a return of the||
8016|043|H|infection.||
8016|044|H|   Tell your doctor if your condition lasts or gets worse.||
8016|045|B|||
8016|046|S|SIDE EFFECTS:  See also Warning section.||
8016|047|S|   Nausea, vomiting, an unpleasant/metallic taste in mouth (if||
8016|048|S|this drug is injected into a vein), or pain at the injection site||
8016|049|S|(if this drug is injected into a muscle) may occur. If any of||
8016|050|S|these effects last or get worse, tell your doctor or pharmacist||
8016|051|S|promptly.||
8016|052|S|   Remember that this medication has been prescribed because your||
8016|053|S|doctor has judged that the benefit to you is greater than the||
8016|054|S|risk of side effects. Many people using this medication do not||
8016|055|S|have serious side effects.||
8016|056|S|   Tell your doctor right away if you have any serious side||
8016|057|S|effects, including: nausea/vomiting that doesn't stop,||
8016|058|S|pain/swelling at injection site (if this drug is injected into a||
8016|059|S|vein), dark urine, yellowing eyes/skin, easy bruising/bleeding,||
8016|060|S|pain in several joints, fast/slow/irregular heartbeat, fainting,||
8016|061|S|signs of kidney problems (such as change in the amount of urine).||
8016|062|S|   Use of this medication for prolonged or repeated periods may||
8016|063|S|result in oral thrush or a new vaginal yeast infection. Contact||
8016|064|S|your doctor if you notice white patches in your mouth, a change||
8016|065|S|in vaginal discharge, or other new symptoms.||
8016|066|S|   A very serious allergic reaction to this drug is rare.||
8016|067|S|However, get medical help right away if you notice any symptoms||
8016|068|S|of a serious allergic reaction, including: fever that doesn't go||
8016|069|S|away, new or worsening lymph node swelling, rash,||
8016|070|S|itching/swelling (especially of the face/tongue/throat), severe||
8016|071|S|dizziness, trouble breathing.||
8016|072|S|   This is not a complete list of possible side effects. If you||
8016|073|S|notice other effects not listed above, contact your doctor or||
8016|074|S|pharmacist.||
8016|075|S|   In the US -||
8016|076|S|   Call your doctor for medical advice about side effects. You||
8016|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8016|078|S|www.fda.gov/medwatch.||
8016|079|S|   In Canada - Call your doctor for medical advice about side||
8016|080|S|effects. You may report side effects to Health Canada at||
8016|081|S|1-866-234-2345.||
8016|082|B|||
8016|083|P|PRECAUTIONS:  Before using clindamycin, tell your doctor or||
8016|084|P|pharmacist if you are allergic to it; or to lincomycin; or if you||
8016|085|P|have any other allergies. This product may contain inactive||
8016|086|P|ingredients (such as benzyl alcohol), which can cause allergic||
8016|087|P|reactions or other problems. Talk to your pharmacist for more||
8016|088|P|details.||
8016|089|P|   Before using this drug, tell your doctor your medical history,||
8016|090|P|especially of: kidney disease, liver disease, stomach/bowel||
8016|091|P|disease (such as colitis).||
8016|092|P|   Clindamycin may cause live bacterial vaccines (such as typhoid||
8016|093|P|vaccine) to not work well. Tell your health care professional||
8016|094|P|that you are using clindamycin before having any||
8016|095|P|immunizations/vaccinations.||
8016|096|P|   Before having surgery, tell your doctor or dentist about all||
8016|097|P|the products you use (including prescription drugs,||
8016|098|P|nonprescription drugs, and herbal products).||
8016|099|P|   Older adults may be more sensitive to the side effects of this||
8016|100|P|drug, especially diarrhea.||
8016|101|P|   Tell your doctor if you are pregnant before using this||
8016|102|P|medication.||
8016|103|P|   This drug passes into breast milk. Consult your doctor before||
8016|104|P|breastfeeding.||
8016|105|B|||
8016|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8016|107|I|medications work or increase your risk for serious side effects.||
8016|108|I|This document does not contain all possible drug interactions.||
8016|109|I|Keep a list of all the products you use (including||
8016|110|I|prescription/nonprescription drugs and herbal products) and share||
8016|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
8016|112|I|the dosage of any medicines without your doctor's approval.||
8016|113|B|||
8016|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8016|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8016|116|O|poison control center right away. US residents can call||
8016|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8016|118|B|||
8016|119|N|NOTES:  Lab and/or medical tests (such as kidney/liver function)||
8016|120|N|may be done while you are using this medication. Consult your||
8016|121|N|doctor for more details.||
8016|122|B|||
8016|123|D|MISSED DOSE:  It is important to get each dose of this medication||
8016|124|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8016|125|D|right away for a new dosing schedule. Do not double the dose to||
8016|126|D|catch up.||
8016|127|B|||
8016|128|R|STORAGE:  Consult the product instructions and your pharmacist||
8016|129|R|for storage details. Keep all medications away from children and||
8016|130|R|pets.||
8016|131|R|   Do not flush medications down the toilet or pour them into a||
8016|132|R|drain unless instructed to do so. Properly discard this product||
8016|133|R|when it is expired or no longer needed. Consult your pharmacist||
8016|134|R|or local waste disposal company.||
8016|135|B|||
8016|136|A|Information last revised December 2024.||
8016|137|A|Copyright(c) 2025 First Databank, Inc.||
8016|138|B|||
8017|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8017|002|Z|does NOT have all possible information about this product. This||
8017|003|Z|information does not assure that this product is safe, effective,||
8017|004|Z|or appropriate for you. This information is not individual||
8017|005|Z|medical advice and does not substitute for the advice of your||
8017|006|Z|health care professional. Always ask your health care||
8017|007|Z|professional for complete information about this product and your||
8017|008|Z|specific health needs.||
8017|009|B|||
8017|010|T|CHORIONIC GONADOTROPIN - INTRAMUSCULAR||
8017|011|F|(KOR-ee-ON-ik goe-NAD-oh-TROE-pin)||
8017|012|B|||
8017|013|C|COMMON BRAND NAME(S): Chorex, Pregnyl||
8017|014|B|||
8017|015|U|USES:  This medication is a hormone used in boys (before puberty)||
8017|016|U|to cause the normal dropping of the testicles into the scrotum.||
8017|017|U|It is also used in certain boys to help with normal sexual||
8017|018|U|development. It works by causing the testes to release male sex||
8017|019|U|hormones (such as testosterone).||
8017|020|U|   This medication is also used in women to treat fertility||
8017|021|U|problems. It is given after finishing another medication||
8017|022|U|(menotropins) to cause the release of an egg (ovulation). It||
8017|023|U|should not be used in women whose ovaries no longer make eggs||
8017|024|U|properly (primary ovarian failure).||
8017|025|U|   This medication has not been shown to be effective for weight||
8017|026|U|loss and should not be used for this purpose due to risk of||
8017|027|U|serious side effects.||
8017|028|B|||
8017|029|H|HOW TO USE:  This medication is given by injection into a muscle||
8017|030|H|as directed by your doctor. It is usually given by a health care||
8017|031|H|professional. For boys, it is usually used 3 times a week. For||
8017|032|H|women, it is usually used for 1 dose after finishing your||
8017|033|H|menotropins treatment. The dosage is based on your age, weight,||
8017|034|H|medical condition, and response to treatment.||
8017|035|H|   If you are using this medication at home, learn all||
8017|036|H|preparation and usage instructions from your health care||
8017|037|H|professional. Before using, check this product for particles or||
8017|038|H|discoloration. If either is present, do not use the liquid. Learn||
8017|039|H|how to store and discard medical supplies safely.||
8017|040|H|   Use this medication regularly to get the most benefit from it.||
8017|041|H|To help you remember, mark your calendar with a reminder.||
8017|042|B|||
8017|043|S|SIDE EFFECTS:  Headache, restlessness, tiredness, or pain at||
8017|044|S|injection site may occur. If any of these effects last or get||
8017|045|S|worse, tell your doctor or pharmacist promptly.||
8017|046|S|   Remember that this medication has been prescribed because your||
8017|047|S|doctor has judged that the benefit to you is greater than the||
8017|048|S|risk of side effects. Many people using this medication do not||
8017|049|S|have serious side effects.||
8017|050|S|   Tell your doctor right away if you have any serious side||
8017|051|S|effects, including: swelling of the hands/ankles/feet,||
8017|052|S|mental/mood changes (such as depression, irritability), signs of||
8017|053|S|early puberty in boys (such as facial/pubic hair, voice change,||
8017|054|S|acne), pain/swelling of the breast (in boys), unusual vaginal||
8017|055|S|bleeding (women).||
8017|056|S|   This medication may cause a condition known as ovarian||
8017|057|S|hyperstimulation syndrome (OHSS). This condition may occur during||
8017|058|S|or after treatment. Rarely, serious OHSS causes fluid to suddenly||
8017|059|S|build up in the stomach, chest, and heart area. Get medical help||
8017|060|S|right away if you develop the following side effects: severe pain||
8017|061|S|or swelling in the lower abdominal (pelvic) area, severe||
8017|062|S|nausea/vomiting, sudden/rapid weight gain, or decreased||
8017|063|S|urination.||
8017|064|S|   Get medical help right away if you have any very serious side||
8017|065|S|effects, including: chest/jaw/left arm pain, sudden severe||
8017|066|S|headache, confusion, weakness on one side of the body, trouble||
8017|067|S|speaking, sudden vision changes, pain/redness/swelling in the||
8017|068|S|legs.||
8017|069|S|   A very serious allergic reaction to this drug is rare.||
8017|070|S|However, get medical help right away if you notice any symptoms||
8017|071|S|of a serious allergic reaction, including: rash, itching/swelling||
8017|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8017|073|S|breathing.||
8017|074|S|   This is not a complete list of possible side effects. If you||
8017|075|S|notice other effects not listed above, contact your doctor or||
8017|076|S|pharmacist.||
8017|077|S|   In the US -||
8017|078|S|   Call your doctor for medical advice about side effects. You||
8017|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8017|080|S|www.fda.gov/medwatch.||
8017|081|S|   In Canada - Call your doctor for medical advice about side||
8017|082|S|effects. You may report side effects to Health Canada at||
8017|083|S|1-866-234-2345.||
8017|084|B|||
8017|085|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
8017|086|P|pharmacist if you are allergic to it; or if you have any other||
8017|087|P|allergies. This product may contain inactive ingredients, which||
8017|088|P|can cause allergic reactions or other problems. Talk to your||
8017|089|P|pharmacist for more details.||
8017|090|P|   Before using this medication, tell your doctor or pharmacist||
8017|091|P|your medical history, especially of: early puberty (in boys),||
8017|092|P|blood clots, heart disease (such as chest pain, heart attack),||
8017|093|P|high blood pressure, kidney disease, liver disease, lung problems||
8017|094|P|(such as asthma), migraine, seizure disorder, stroke, unusual||
8017|095|P|vaginal bleeding, problems of the uterus, unexplained ovarian||
8017|096|P|cyst/enlargement, certain type of fertility problem (primary||
8017|097|P|ovarian failure), thyroid problem, adrenal gland problem, cancer||
8017|098|P|of the reproductive organs (breast, uterus, ovary, prostate),||
8017|099|P|brain tumor.||
8017|100|P|   This medication should not be used during pregnancy. If you||
8017|101|P|become pregnant or think you may be pregnant, tell your doctor||
8017|102|P|right away.||
8017|103|P|   When this medication is used in women to treat infertility, it||
8017|104|P|may cause multiple births (such as twins, triplets).||
8017|105|P|   It is unknown if this drug passes into breast milk. Consult||
8017|106|P|your doctor before breastfeeding.||
8017|107|B|||
8017|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8017|109|I|medications work or increase your risk for serious side effects.||
8017|110|I|This document does not contain all possible drug interactions.||
8017|111|I|Keep a list of all the products you use (including||
8017|112|I|prescription/nonprescription drugs and herbal products) and share||
8017|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
8017|114|I|the dosage of any medicines without your doctor's approval.||
8017|115|I|   A product that may interact with this drug is: gonadorelin.||
8017|116|I|   This medication may interfere with certain lab tests||
8017|117|I|(including luteinizing hormone-LH/follicle stimulating||
8017|118|I|hormone-FSH levels), possibly causing false test results. Make||
8017|119|I|sure lab personnel and all your doctors know you use this drug.||
8017|120|B|||
8017|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8017|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8017|123|O|poison control center right away. US residents can call||
8017|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8017|125|B|||
8017|126|N|NOTES:  Do not share this medication with others.||
8017|127|B|||
8017|128|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
8017|129|D|right away for a new dosing schedule.||
8017|130|B|||
8017|131|R|STORAGE:  Store the vials of powder at room temperature away from||
8017|132|R|light and moisture. Store the mixed medication in the||
8017|133|R|refrigerator. Depending on your product, discard the unused mixed||
8017|134|R|medication after 1 to 2 months. Check the product package for the||
8017|135|R|storage time for your product. Keep all medications away from||
8017|136|R|children and pets.||
8017|137|R|   Do not flush medications down the toilet or pour them into a||
8017|138|R|drain unless instructed to do so. Properly discard this product||
8017|139|R|when it is expired or no longer needed. Consult your pharmacist||
8017|140|R|or local waste disposal company.||
8017|141|B|||
8017|142|A|Information last revised October 2024.||
8017|143|A|Copyright(c) 2025 First Databank, Inc.||
8017|144|B|||
8019|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8019|002|Z|does NOT have all possible information about this product. This||
8019|003|Z|information does not assure that this product is safe, effective,||
8019|004|Z|or appropriate for you. This information is not individual||
8019|005|Z|medical advice and does not substitute for the advice of your||
8019|006|Z|health care professional. Always ask your health care||
8019|007|Z|professional for complete information about this product and your||
8019|008|Z|specific health needs.||
8019|009|B|||
8019|010|T|DIVALPROEX SODIUM ENTERIC-COATED TABLET - ORAL||
8019|011|F|(dye-VAL-pro-ex SO-dee-um)||
8019|012|B|||
8019|013|C|COMMON BRAND NAME(S): Depakote||
8019|014|B|||
8019|015|W|WARNING:  Rarely, this medication has caused serious (sometimes||
8019|016|W|fatal) liver problems, usually within the first 6 months of||
8019|017|W|starting treatment. Lab tests should be performed before you||
8019|018|W|start treatment and periodically during treatment, especially||
8019|019|W|within the first 6 months, to monitor this side effect.||
8019|020|W|   The risk of serious liver problems is increased in children||
8019|021|W|younger than 2 years, especially if they have an inherited||
8019|022|W|metabolic disorder, severe seizure disorder with mental||
8019|023|W|retardation, organic brain disease, or if they take more than one||
8019|024|W|seizure medication. Talk with the doctor about the risks and||
8019|025|W|benefits of using this medication in children younger than 2||
8019|026|W|years.||
8019|027|W|   Due to an increased risk for liver problems, people with||
8019|028|W|certain inherited metabolic disorders (such as||
8019|029|W|Alpers-Huttenlocher syndrome) should not use this medication.||
8019|030|W|Children younger than 2 years who might have these disorders||
8019|031|W|should not use this medication. Children older than 2 years who||
8019|032|W|might have these disorders should be closely monitored during||
8019|033|W|treatment with divalproex sodium. Talk to your doctor for||
8019|034|W|details.||
8019|035|W|   This medication has rarely caused severe (sometimes fatal)||
8019|036|W|disease of the pancreas (pancreatitis). This may occur at any||
8019|037|W|time during treatment and can quickly worsen.||
8019|038|W|   Tell your doctor right away if you develop symptoms of liver||
8019|039|W|problems or pancreatitis such as nausea/vomiting that doesn't||
8019|040|W|stop, unusual tiredness, weakness, swelling of the face,||
8019|041|W|stomach/abdominal pain, loss of appetite, dark urine, or||
8019|042|W|yellowing eyes/skin.||
8019|043|W|   Taking this medication during pregnancy can cause birth||
8019|044|W|defects, may lower your child's IQ, and may increase the risk of||
8019|045|W|your child having certain brain/mental disorders (such as autism,||
8019|046|W|attention deficit/hyperactivity disorder). Men and women using||
8019|047|W|this medication should discuss the risks and benefits of this||
8019|048|W|medication, other treatment options, and use of reliable forms of||
8019|049|W|birth control with their doctor. If you are planning pregnancy,||
8019|050|W|or if you or your partner becomes pregnant or may be pregnant,||
8019|051|W|immediately talk to your doctor. If you are taking divalproex||
8019|052|W|sodium only to prevent migraine headaches, this medication must||
8019|053|W|not be used during pregnancy. If you are taking divalproex sodium||
8019|054|W|to treat seizures or mental/mood problems (such as bipolar||
8019|055|W|disorder), do not stop taking this medication unless directed by||
8019|056|W|your doctor. Untreated seizures and mental/mood problems (such as||
8019|057|W|bipolar disorder) are serious conditions that can harm both a||
8019|058|W|pregnant woman and her unborn baby.||
8019|059|B|||
8019|060|U|USES:  This medication is used to treat seizure disorders,||
8019|061|U|certain psychiatric conditions (manic phase of bipolar disorder),||
8019|062|U|and to prevent migraine headaches. It works by restoring the||
8019|063|U|balance of certain natural substances (neurotransmitters) in the||
8019|064|U|brain.||
8019|065|B|||
8019|066|H|HOW TO USE:  Read the Medication Guide and, if available, the||
8019|067|H|Patient Information Leaflet provided by your pharmacist before||
8019|068|H|you start taking divalproex sodium and each time you get a||
8019|069|H|refill. If you have any questions, ask your doctor or pharmacist.||
8019|070|H|   Take this medication by mouth as directed by your doctor. You||
8019|071|H|may take it with food if stomach upset occurs. Swallow the tablet||
8019|072|H|whole. Do not crush or chew the tablet, which can irritate the||
8019|073|H|mouth or throat.||
8019|074|H|   The dosage is based on your age, weight, medical condition,||
8019|075|H|response to treatment, and other medications you may be taking.||
8019|076|H|Be sure to tell your doctor and pharmacist about all the products||
8019|077|H|you use (including prescription drugs, nonprescription drugs, and||
8019|078|H|herbal products). Use this medication regularly in order to get||
8019|079|H|the most benefit from it. Remember to use it at the same time||
8019|080|H|each day to keep the amount of medication in your blood constant.||
8019|081|H|   If this medication is used for seizures, do not stop taking it||
8019|082|H|without consulting your doctor. Your condition may become worse||
8019|083|H|if the drug is suddenly stopped. Your dose may need to be||
8019|084|H|gradually decreased.||
8019|085|H|   Divalproex sodium does not relieve acute migraine headaches.||
8019|086|H|Take other medications as directed by your doctor for acute||
8019|087|H|attacks.||
8019|088|H|   Tell your doctor if your condition does not get better.||
8019|089|B|||
8019|090|S|SIDE EFFECTS:  See also Warning section.||
8019|091|S|   Diarrhea, dizziness, drowsiness, hair loss, blurred/double||
8019|092|S|vision, change in menstrual periods, ringing in the ears,||
8019|093|S|shakiness (tremor), unsteadiness, weight changes may occur. If||
8019|094|S|any of these effects last or get worse, tell your doctor or||
8019|095|S|pharmacist promptly.||
8019|096|S|   You may rarely see partial tablets in your stool. This may||
8019|097|S|occur if you have certain intestinal disorders (such as||
8019|098|S|ileostomy, colostomy). Tell your doctor right away if you see||
8019|099|S|partial tablets in your stool.||
8019|100|S|   Remember that this medication has been prescribed because your||
8019|101|S|doctor has judged that the benefit to you is greater than the||
8019|102|S|risk of side effects. Many people using this medication do not||
8019|103|S|have serious side effects.||
8019|104|S|   A small number of people who take anticonvulsants for any||
8019|105|S|condition (such as seizure, bipolar disorder, pain) may||
8019|106|S|experience depression, suicidal thoughts/attempts, or other||
8019|107|S|mental/mood problems. Tell your doctor right away if you or your||
8019|108|S|family/caregiver notice any unusual/sudden changes in your mood,||
8019|109|S|thoughts, or behavior including signs of depression, suicidal||
8019|110|S|thoughts/attempts, thoughts about harming yourself.||
8019|111|S|   Severe (sometimes fatal) brain disorder (encephalopathy) has||
8019|112|S|rarely occurred, particularly in patients with certain metabolic||
8019|113|S|disorders (urea cycle disorders). Tell your doctor right away if||
8019|114|S|you develop unexplained weakness, vomiting, or sudden mental/mood||
8019|115|S|changes (such as confusion).||
8019|116|S|   Get medical help right away if you have any very serious side||
8019|117|S|effects, including: chest pain, easy bruising/unexplained||
8019|118|S|bleeding, fast/slow/irregular heartbeat, swelling of hands/feet,||
8019|119|S|uncontrolled eye movement (nystagmus), feeling cold/shivering,||
8019|120|S|rapid breathing, loss of consciousness.||
8019|121|S|   A very serious allergic reaction to this drug is rare.||
8019|122|S|However, get medical help right away if you notice any symptoms||
8019|123|S|of a serious allergic reaction, including: fever, swollen lymph||
8019|124|S|nodes, rash, itching/swelling (especially of the||
8019|125|S|face/tongue/throat), severe dizziness, trouble breathing.||
8019|126|S|   This is not a complete list of possible side effects. If you||
8019|127|S|notice other effects not listed above, contact your doctor or||
8019|128|S|pharmacist.||
8019|129|S|   In the US -||
8019|130|S|   Call your doctor for medical advice about side effects. You||
8019|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8019|132|S|www.fda.gov/medwatch.||
8019|133|S|   In Canada - Call your doctor for medical advice about side||
8019|134|S|effects. You may report side effects to Health Canada at||
8019|135|S|1-866-234-2345.||
8019|136|B|||
8019|137|P|PRECAUTIONS:  See also Warning section.||
8019|138|P|   Before taking divalproex sodium, tell your doctor or||
8019|139|P|pharmacist if you are allergic to it; or to valproic acid or||
8019|140|P|valproate sodium; or if you have any other allergies. This||
8019|141|P|product may contain inactive ingredients, which can cause||
8019|142|P|allergic reactions or other problems. Talk to your pharmacist for||
8019|143|P|more details.||
8019|144|P|   Before using this medication, tell your doctor or pharmacist||
8019|145|P|your medical history, especially of: liver disease, pancreatitis,||
8019|146|P|certain metabolic disorders (such as urea cycle disorders,||
8019|147|P|Alpers-Huttenlocher syndrome), alcohol abuse, bleeding problems,||
8019|148|P|brain disease (dementia), kidney disease, dehydration, poor||
8019|149|P|nutrition.||
8019|150|P|   To lower the chance of getting cut, bruised, or injured, use||
8019|151|P|caution with sharp objects like razors and nail cutters, and||
8019|152|P|avoid activities such as contact sports.||
8019|153|P|   Before having surgery, tell your doctor or dentist about all||
8019|154|P|the products you use (including prescription drugs,||
8019|155|P|nonprescription drugs, and herbal products).||
8019|156|P|   This drug may make you dizzy or drowsy or blur your vision.||
8019|157|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8019|158|P|drowsy. Do not drive, use machinery, or do anything that needs||
8019|159|P|alertness or clear vision until you can do it safely. Avoid||
8019|160|P|alcoholic beverages. Talk to your doctor if you are using||
8019|161|P|marijuana (cannabis).||
8019|162|P|   Children younger than 6 years may be at greater risk for liver||
8019|163|P|problems and pancreatitis.||
8019|164|P|   Older adults may be more sensitive to the side effects of this||
8019|165|P|drug, especially drowsiness, dizziness, unsteadiness, or tremor.||
8019|166|P|Drowsiness, dizziness, unsteadiness can increase the risk of||
8019|167|P|falling.||
8019|168|P|   Tell your doctor if you are pregnant or plan to become||
8019|169|P|pregnant. You should not become pregnant while using divalproex||
8019|170|P|sodium. Divalproex sodium may harm an unborn baby. If you become||
8019|171|P|pregnant, talk to your doctor right away about the risks and||
8019|172|P|benefits of this medication. See also Warning section.||
8019|173|P|   This medication passes into breast milk. Consult your doctor||
8019|174|P|before breastfeeding.||
8019|175|B|||
8019|176|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8019|177|I|medications work or increase your risk for serious side effects.||
8019|178|I|This document does not contain all possible drug interactions.||
8019|179|I|Keep a list of all the products you use (including||
8019|180|I|prescription/nonprescription drugs and herbal products) and share||
8019|181|I|it with your doctor and pharmacist. Do not start, stop, or change||
8019|182|I|the dosage of any medicines without your doctor's approval.||
8019|183|I|   Some products that may interact with this drug include:||
8019|184|I|certain antidepressants (such as amitriptyline, nortriptyline,||
8019|185|I|phenelzine), certain antibiotics (carbapenems such as imipenem),||
8019|186|I|mefloquine, orlistat, other medications for seizure (such as||
8019|187|I|ethosuximide, lamotrigine, rufinamide, topiramate), warfarin,||
8019|188|I|vorinostat, zidovudine.||
8019|189|I|   Tell your doctor or pharmacist if you are taking other||
8019|190|I|products that cause drowsiness including alcohol, marijuana||
8019|191|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
8019|192|I|drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle||
8019|193|I|relaxants (such as carisoprodol, cyclobenzaprine), and opioid||
8019|194|I|pain relievers (such as codeine, hydrocodone).||
8019|195|I|   Check the labels on all your medicines (such as allergy or||
8019|196|I|cough-and-cold products) because they may contain ingredients||
8019|197|I|that cause drowsiness. Ask your pharmacist about using those||
8019|198|I|products safely.||
8019|199|I|   This drug may interfere with certain lab tests (such as urine||
8019|200|I|ketones). Make sure lab personnel and your doctors know you use||
8019|201|I|this medication.||
8019|202|B|||
8019|203|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8019|204|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8019|205|O|poison control center right away. US residents can call||
8019|206|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8019|207|O|Symptoms of overdose may include: excessive drowsiness, coma,||
8019|208|O|irregular/slow heartbeat.||
8019|209|B|||
8019|210|N|NOTES:  Do not share this medication with others.||
8019|211|N|   Lab and/or medical tests (such as drug levels, liver function,||
8019|212|N|complete blood counts, clotting tests) should be done before you||
8019|213|N|start taking this medication and while you are taking it. Keep||
8019|214|N|all medical and lab appointments. Consult your doctor for more||
8019|215|N|details.||
8019|216|B|||
8019|217|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8019|218|D|remember. If it is near the time of the next dose, skip the||
8019|219|D|missed dose. Take your next dose at the regular time. Do not||
8019|220|D|double the dose to catch up.||
8019|221|B|||
8019|222|R|STORAGE:  Store at room temperature away from light and moisture.||
8019|223|R|Do not store in the bathroom. Keep all medications away from||
8019|224|R|children and pets.||
8019|225|R|   Do not flush medications down the toilet or pour them into a||
8019|226|R|drain unless instructed to do so. Properly discard this product||
8019|227|R|when it is expired or no longer needed. Consult your pharmacist||
8019|228|R|or local waste disposal company.||
8019|229|B|||
8019|230|M|MEDICAL ALERT:  Your condition can cause complications in a||
8019|231|M|medical emergency. For information about enrolling in MedicAlert,||
8019|232|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8019|233|B|||
8019|234|A|Information last revised January 2025.||
8019|235|A|Copyright(c) 2025 First Databank, Inc.||
8019|236|B|||
8020|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8020|002|Z|does NOT have all possible information about this product. This||
8020|003|Z|information does not assure that this product is safe, effective,||
8020|004|Z|or appropriate for you. This information is not individual||
8020|005|Z|medical advice and does not substitute for the advice of your||
8020|006|Z|health care professional. Always ask your health care||
8020|007|Z|professional for complete information about this product and your||
8020|008|Z|specific health needs.||
8020|009|B|||
8020|010|T|PROBENECID/COLCHICINE - ORAL||
8020|011|F|(proe-BEN-e-sid/KOL-chi-seen)||
8020|012|B|||
8020|013|C|COMMON BRAND NAME(S): Col-Benemid||
8020|014|B|||
8020|015|U|USES:  This medication is a combination of probenecid and||
8020|016|U|colchicine. It is used to prevent gout and gouty arthritis in||
8020|017|U|people who have frequent severe gout attacks. Gout is caused by||
8020|018|U|too much uric acid in the blood. When uric acid levels in the||
8020|019|U|blood are too high, the uric acid may form hard crystals in your||
8020|020|U|joints. Usually gout symptoms develop suddenly and involve only||
8020|021|U|one or a few joints. The big toe, knee, or ankle joints are most||
8020|022|U|often affected.||
8020|023|U|   Probenecid belongs to a class of drugs known as uricosurics.||
8020|024|U|It works by speeding up the removal of uric acid by your kidneys.||
8020|025|U|This decreases uric acid in the blood. Colchicine works by||
8020|026|U|decreasing swelling and lessening the build up of uric acid||
8020|027|U|crystals that cause pain in the affected joint(s).||
8020|028|U|   This combination product is not a pain medication. You should||
8020|029|U|not begin treatment with this medication during a sudden gout||
8020|030|U|attack (flare). Doing so may worsen your pain during the attack.||
8020|031|U|Follow your doctor's directions for treating a sudden/severe gout||
8020|032|U|attack before you start taking this product.||
8020|033|U|   This product should not be used by children younger than 2||
8020|034|U|years.||
8020|035|B|||
8020|036|H|HOW TO USE:  Take this medication by mouth as directed by your||
8020|037|H|doctor, usually twice daily with a full glass of water (8||
8020|038|H|ounces/240 milliliters). If stomach upset occurs, this medication||
8020|039|H|may be taken with food or antacid. To prevent kidney stones while||
8020|040|H|taking this drug, drink plenty of fluids throughout the day||
8020|041|H|unless your doctor directs you otherwise. Taking products such as||
8020|042|H|sodium bicarbonate and avoiding large amounts of vitamin C can||
8020|043|H|also help reduce your risk for kidney stones. Ask your doctor for||
8020|044|H|more details.||
8020|045|H|   The dosage is based on your medical condition and response to||
8020|046|H|treatment. To reduce your risk for serious side effects, do not||
8020|047|H|increase your dose, take it more often, or take it for a longer||
8020|048|H|time than directed by your doctor. Your doctor may start you on a||
8020|049|H|lower dose and adjust your dose during treatment with this||
8020|050|H|medication.||
8020|051|H|   After starting this medication, you may have an increase in||
8020|052|H|the number of gout attacks while your body gets rid of extra uric||
8020|053|H|acid. This may last for several months until the uric acid in||
8020|054|H|your blood is lowered. Do not stop taking this drug if you have a||
8020|055|H|sudden gout attack. Keep taking it along with the medications||
8020|056|H|(such as colchicine, ibuprofen, indomethacin) prescribed by your||
8020|057|H|doctor for gout pain.||
8020|058|H|   Avoid eating grapefruit or drinking grapefruit juice while||
8020|059|H|using this medication unless your doctor or pharmacist says you||
8020|060|H|may do so safely. Grapefruit can increase the chance of side||
8020|061|H|effects with this medicine. Ask your doctor or pharmacist for||
8020|062|H|more details.||
8020|063|H|   Use this medication regularly to get the most benefit from it.||
8020|064|H|To help you remember, take it at the same times each day.||
8020|065|H|   Tell your doctor if your condition does not get better or if||
8020|066|H|it gets worse.||
8020|067|B|||
8020|068|S|SIDE EFFECTS:  Nausea, cramping, diarrhea, loss of appetite,||
8020|069|S|dizziness, hair loss, headache, vomiting, and frequent urination||
8020|070|S|may occur. If any of these effects last or get worse, tell your||
8020|071|S|doctor or pharmacist promptly.||
8020|072|S|   Remember that this medication has been prescribed because your||
8020|073|S|doctor has judged that the benefit to you is greater than the||
8020|074|S|risk of side effects. Many people using this medication do not||
8020|075|S|have serious side effects.||
8020|076|S|   Tell your doctor right away if you have any serious side||
8020|077|S|effects, including: nausea/vomiting that doesn't stop, muscle||
8020|078|S|weakness or pain, numbness/tingling in your fingers or toes, pale||
8020|079|S|or gray color of the lips/tongue/palms of hands, severe diarrhea,||
8020|080|S|severe stomach/abdominal pain, signs of infection (such as sore||
8020|081|S|throat that doesn't go away, fever, chills), unusual||
8020|082|S|bleeding/bruising, unusual weakness/tiredness, dark urine,||
8020|083|S|yellowing eyes/skin, fast heartbeat, shortness of breath, signs||
8020|084|S|of kidney problems (such as change in the amount of urine).||
8020|085|S|   A very serious allergic reaction to this drug is rare.||
8020|086|S|However, get medical help right away if you notice any symptoms||
8020|087|S|of a serious allergic reaction, including: rash, itching/swelling||
8020|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8020|089|S|breathing.||
8020|090|S|   This is not a complete list of possible side effects. If you||
8020|091|S|notice other effects not listed above, contact your doctor or||
8020|092|S|pharmacist.||
8020|093|S|   In the US -||
8020|094|S|   Call your doctor for medical advice about side effects. You||
8020|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8020|096|S|www.fda.gov/medwatch.||
8020|097|S|   In Canada - Call your doctor for medical advice about side||
8020|098|S|effects. You may report side effects to Health Canada at||
8020|099|S|1-866-234-2345.||
8020|100|B|||
8020|101|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
8020|102|P|pharmacist if you are allergic to probenecid or colchicine; or if||
8020|103|P|you have any other allergies. This product may contain inactive||
8020|104|P|ingredients, which can cause allergic reactions or other||
8020|105|P|problems. Talk to your pharmacist for more details.||
8020|106|P|   Before using this medication, tell your doctor or pharmacist||
8020|107|P|your medical history, especially of: blood/bleeding problems,||
8020|108|P|cancer treatment, a certain enzyme deficiency (G6PD), kidney||
8020|109|P|problems (such as kidney stones), liver problems (such as||
8020|110|P|cirrhosis), stomach ulcer.||
8020|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8020|112|P|can make you more dizzy. Do not drive, use machinery, or do||
8020|113|P|anything that needs alertness until you can do it safely. Limit||
8020|114|P|alcoholic beverages. Talk to your doctor if you are using||
8020|115|P|marijuana (cannabis). Alcohol may also decrease this drug's||
8020|116|P|effectiveness.||
8020|117|P|   This medication can affect how well your body absorbs some||
8020|118|P|foods and nutrients (such as vitamin B12). Consult your doctor or||
8020|119|P|pharmacist for more details.||
8020|120|P|   Before having surgery, tell your doctor or dentist about all||
8020|121|P|the products you use (including prescription drugs,||
8020|122|P|nonprescription drugs, and herbal products).||
8020|123|P|   Older adults may be more sensitive to the side effects of this||
8020|124|P|drug, especially muscle weakness/pain and numbness/tingling in||
8020|125|P|their fingers or toes.||
8020|126|P|   Colchicine can decrease sperm production, which may affect the||
8020|127|P|ability of a male to father a child. Consult your doctor for more||
8020|128|P|information.||
8020|129|P|   During pregnancy, this medication should be used only when||
8020|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
8020|131|P|   This drug passes into breast milk. Consult your doctor before||
8020|132|P|breastfeeding.||
8020|133|B|||
8020|134|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
8020|135|I|   Drug interactions may change how your medications work or||
8020|136|I|increase your risk for serious side effects. This document does||
8020|137|I|not contain all possible drug interactions. Keep a list of all||
8020|138|I|the products you use (including prescription/nonprescription||
8020|139|I|drugs and herbal products) and share it with your doctor and||
8020|140|I|pharmacist. Do not start, stop, or change the dosage of any||
8020|141|I|medicines without your doctor's approval.||
8020|142|I|   This medication can slow down the removal of other medications||
8020|143|I|from your body, which may affect how they work. Examples of||
8020|144|I|affected drugs include irinotecan, ketoprofen, ketorolac,||
8020|145|I|methotrexate, pralatrexate among others.||
8020|146|I|   Other medications can affect the removal of this medication||
8020|147|I|from your body, which may affect how this drug works. Examples||
8020|148|I|include atazanavir, certain azole antifungals (such as||
8020|149|I|itraconazole, ketoconazole), diltiazem, macrolide antibiotics||
8020|150|I|(such as clarithromycin, erythromycin), ritonavir, telithromycin,||
8020|151|I|verapamil, among others.||
8020|152|I|   This medication may rarely cause a certain serious (even||
8020|153|I|fatal) muscle damage (rhabdomyolysis). This muscle damage||
8020|154|I|releases substances that can lead to serious kidney problems. The||
8020|155|I|risk may be increased if other drugs that may also cause||
8020|156|I|rhabdomyolysis are taken along with this drug. Some affected||
8020|157|I|drugs include: digoxin, gemfibrozil, pravastatin, simvastatin,||
8020|158|I|among others.||
8020|159|I|   This medication may interfere with certain lab tests (such as||
8020|160|I|urine glucose tests), possibly causing false test results. Make||
8020|161|I|sure lab personnel and all your doctors know you use this drug.||
8020|162|B|||
8020|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8020|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8020|165|O|poison control center right away. US residents can call||
8020|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8020|167|O|Symptoms of overdose may include: severe vomiting, loss of||
8020|168|O|consciousness, seizures.||
8020|169|B|||
8020|170|N|NOTES:  Do not share this medication with others.||
8020|171|N|   Being overweight, drinking too much alcohol, and eating||
8020|172|N|certain foods may worsen gout symptoms. Limit alcohol and ask||
8020|173|N|your doctor, pharmacist, or dietitian about avoiding foods high||
8020|174|N|in purines that may worsen gout (such as anchovies, bacon, beer,||
8020|175|N|sardines, organ meats including liver/kidneys).||
8020|176|N|   Lab and/or medical tests (such as uric acid blood levels,||
8020|177|N|liver/kidney function, complete blood count) may be done while||
8020|178|N|you are taking this medication. Keep all medical and lab||
8020|179|N|appointments. Consult your doctor for more details.||
8020|180|B|||
8020|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8020|182|D|remember. If it is near the time of the next dose, skip the||
8020|183|D|missed dose. Take your next dose at the regular time. Do not||
8020|184|D|double the dose to catch up.||
8020|185|B|||
8020|186|R|STORAGE:  Store at room temperature away from light and moisture.||
8020|187|R|Do not store in the bathroom. Keep all medications away from||
8020|188|R|children and pets.||
8020|189|R|   Do not flush medications down the toilet or pour them into a||
8020|190|R|drain unless instructed to do so. Properly discard this product||
8020|191|R|when it is expired or no longer needed. Consult your pharmacist||
8020|192|R|or local waste disposal company.||
8020|193|B|||
8020|194|A|Information last revised August 2025.||
8020|195|A|Copyright(c) 2025 First Databank, Inc.||
8020|196|B|||
8022|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8022|002|Z|does NOT have all possible information about this product. This||
8022|003|Z|information does not assure that this product is safe, effective,||
8022|004|Z|or appropriate for you. This information is not individual||
8022|005|Z|medical advice and does not substitute for the advice of your||
8022|006|Z|health care professional. Always ask your health care||
8022|007|Z|professional for complete information about this product and your||
8022|008|Z|specific health needs.||
8022|009|B|||
8022|010|T|HEPARIN - INJECTION||
8022|011|F|(HEP-a-rin)||
8022|012|B|||
8022|013|U|USES:  This medication is used to prevent and treat blood clots.||
8022|014|U|It may be used to prevent and treat blood clots in the lungs/legs||
8022|015|U|(including in patients with atrial fibrillation). It may be used||
8022|016|U|to treat certain blood clotting disorders. It may also be used to||
8022|017|U|prevent blood clots after surgery, during dialysis, during blood||
8022|018|U|transfusions, when collecting blood samples, or when a person is||
8022|019|U|unable to move for a long time. Heparin helps to keep blood||
8022|020|U|flowing smoothly by making a certain natural substance in your||
8022|021|U|body (anti-clotting protein) work better. It is known as an||
8022|022|U|anticoagulant.||
8022|023|B|||
8022|024|V|OTHER USES:  This section contains uses of this drug that are not||
8022|025|V|listed in the approved professional labeling for the drug but||
8022|026|V|that may be prescribed by your health care professional. Use this||
8022|027|V|drug for a condition that is listed in this section only if it||
8022|028|V|has been so prescribed by your health care professional.||
8022|029|V|   This drug may also be used to reduce the risk of blood clots||
8022|030|V|in people who have had certain types of heart attack, or who have||
8022|031|V|a certain type of chest pain called unstable angina.||
8022|032|B|||
8022|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8022|034|H|from your pharmacist before you start using heparin and each time||
8022|035|H|you get a refill. If you have any questions, ask your doctor or||
8022|036|H|pharmacist.||
8022|037|H|   This medication is given by injection into a vein or under the||
8022|038|H|skin as directed by your doctor. Do not inject this medication||
8022|039|H|into a muscle. The dosage and how often you use it are based on||
8022|040|H|your medical condition, weight, and response to treatment.||
8022|041|H|   Heparin comes in many strengths. Serious (sometimes fatal)||
8022|042|H|injuries have occurred when the wrong strength was used. Check||
8022|043|H|that you are using the correct strength and dose before injecting||
8022|044|H|this medication.||
8022|045|H|   If you are giving this medication to yourself at home, learn||
8022|046|H|all preparation and usage instructions from your health care||
8022|047|H|professional. Before using, check this product for particles or||
8022|048|H|discoloration. If either is present, do not use the liquid. Learn||
8022|049|H|how to store and discard medical supplies safely.||
8022|050|H|   If you are injecting heparin into a vein, flush the||
8022|051|H|catheter/line with normal saline before and after infusing drugs||
8022|052|H|that interact with heparin such as doxorubicin, droperidol,||
8022|053|H|ciprofloxacin, and mitoxantrone.||
8022|054|H|   If you are injecting heparin under the skin, clean the skin||
8022|055|H|you are going to inject into (the injection site) with rubbing||
8022|056|H|alcohol. Change the injection site each time to lessen injury||
8022|057|H|under the skin.||
8022|058|H|   Use this medication regularly to get the most benefit from it.||
8022|059|H|To help you remember, use it at the same times each day.||
8022|060|H|   Your doctor may direct you to switch to an anticoagulant taken||
8022|061|H|by mouth (such as warfarin). Use this medication and any new||
8022|062|H|medication exactly as directed by your doctor.||
8022|063|B|||
8022|064|S|SIDE EFFECTS:  Mild pain/redness/irritation at the injection site||
8022|065|S|may occur. If any of these effects last or get worse, tell your||
8022|066|S|doctor or pharmacist promptly.||
8022|067|S|   Remember that this medication has been prescribed because your||
8022|068|S|doctor has judged that the benefit to you is greater than the||
8022|069|S|risk of side effects. Many people using this medication do not||
8022|070|S|have serious side effects.||
8022|071|S|   Tell your doctor right away if you have any serious side||
8022|072|S|effects, including: swelling at injection site, bone pain, easily||
8022|073|S|broken bones.||
8022|074|S|   This medication can cause bleeding if its effect on your||
8022|075|S|clotting proteins is too much. Tell your doctor right away if you||
8022|076|S|develop any signs of serious bleeding, including unusual||
8022|077|S|pain/swelling/discomfort, prolonged bleeding from cuts or gums,||
8022|078|S|frequent nosebleeds, unusually heavy/prolonged menstrual periods,||
8022|079|S|unusual/easy bruising, dark urine, black stools, severe headache,||
8022|080|S|unusual dizziness.||
8022|081|S|   This drug may rarely cause certain serious (rarely fatal)||
8022|082|S|clotting problems (heparin-induced thrombocytopenia-HIT or||
8022|083|S|heparin-induced thrombocytopenia and thrombosis-HITT). This can||
8022|084|S|occur during treatment and up to several weeks after treatment||
8022|085|S|with heparin has stopped. You should not use heparin again if you||
8022|086|S|have HIT or HITT. If you notice any of the following very serious||
8022|087|S|side effects, get medical help right away: pain/loss of feeling||
8022|088|S|in the arms/legs, change in color of the arms/legs, chest pain,||
8022|089|S|trouble breathing, confusion, weakness on one side of the body,||
8022|090|S|trouble speaking, vision changes.||
8022|091|S|   A very serious allergic reaction to this drug is rare.||
8022|092|S|However, get medical help right away if you notice any symptoms||
8022|093|S|of a serious allergic reaction, including: fever, chills, rash,||
8022|094|S|itching/swelling (especially of the face/tongue/throat), severe||
8022|095|S|dizziness, trouble breathing.||
8022|096|S|   This is not a complete list of possible side effects. If you||
8022|097|S|notice other effects not listed above, contact your doctor or||
8022|098|S|pharmacist.||
8022|099|S|   In the US -||
8022|100|S|   Call your doctor for medical advice about side effects. You||
8022|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8022|102|S|www.fda.gov/medwatch.||
8022|103|S|   In Canada - Call your doctor for medical advice about side||
8022|104|S|effects. You may report side effects to Health Canada at||
8022|105|S|1-866-234-2345.||
8022|106|B|||
8022|107|P|PRECAUTIONS:  Before using heparin, tell your doctor or||
8022|108|P|pharmacist if you are allergic to it; or to pork products; or to||
8022|109|P|pentosan polysulfate sodium; or if you have any other allergies.||
8022|110|P|This product may contain inactive ingredients (such as benzyl||
8022|111|P|alcohol found in some brands), which can cause allergic reactions||
8022|112|P|or other problems. Talk to your pharmacist for more details.||
8022|113|P|   Before using this medication, tell your doctor or pharmacist||
8022|114|P|your medical history, especially of: bleeding/blood problems||
8022|115|P|(such as low platelet count, hemophilia), high blood pressure||
8022|116|P|(hypertension), heart problems (such as infection of the heart,||
8022|117|P|heart attack), recent surgery/procedure, cancer,||
8022|118|P|stomach/intestinal ulcers or tube drainage, liver disease, high||
8022|119|P|level of potassium in the blood.||
8022|120|P|   To lower the chance of getting cut, bruised, or injured, use||
8022|121|P|caution with sharp objects like razors and nail cutters, and||
8022|122|P|avoid activities such as contact sports.||
8022|123|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
8022|124|P|while using this medicine will increase your risk for stomach||
8022|125|P|bleeding. Limit alcoholic beverages. Ask your doctor or||
8022|126|P|pharmacist about how much alcohol you may safely drink.||
8022|127|P|   Before having surgery, tell your doctor or dentist about all||
8022|128|P|the products you use (including prescription drugs,||
8022|129|P|nonprescription drugs, and herbal products).||
8022|130|P|   This medication contains sodium. Consult your doctor or||
8022|131|P|pharmacist if you are on a salt-restricted diet or if you have a||
8022|132|P|condition that could worsen if you have more salt (such as heart||
8022|133|P|failure).||
8022|134|P|   Older adults, especially women over 60 years of age, may be||
8022|135|P|more sensitive to the side effects of this drug, especially||
8022|136|P|bleeding.||
8022|137|P|   During pregnancy, this medication should be used only when||
8022|138|P|clearly needed. Discuss the risks and benefits with your doctor.||
8022|139|P|   This medication does not pass into breast milk. Consult your||
8022|140|P|doctor before breastfeeding.||
8022|141|B|||
8022|142|I|DRUG INTERACTIONS:  See also How to Use section.||
8022|143|I|   Drug interactions may change how your medications work or||
8022|144|I|increase your risk for serious side effects. This document does||
8022|145|I|not contain all possible drug interactions. Keep a list of all||
8022|146|I|the products you use (including prescription/nonprescription||
8022|147|I|drugs and herbal products) and share it with your doctor and||
8022|148|I|pharmacist. Do not start, stop, or change the dosage of any||
8022|149|I|medicines without your doctor's approval.||
8022|150|I|   Some products that may interact with this drug include:||
8022|151|I|mifepristone, oritavancin, telavancin, other drugs that can cause||
8022|152|I|bleeding/bruising (including "blood thinners" such as||
8022|153|I|apixaban/dabigatran).||
8022|154|I|   This medication is sometimes used together with other drugs||
8022|155|I|that have "blood thinning" or anti-platelet effects such as||
8022|156|I|aspirin, clopidogrel, or warfarin. If your doctor prescribes a||
8022|157|I|combination of these drugs, your doctor will monitor you closely||
8022|158|I|to minimize your risk of bleeding. Keep all medical and lab||
8022|159|I|appointments.||
8022|160|I|   Check all prescription and nonprescription medicine labels||
8022|161|I|carefully since many medications contain pain relievers/fever||
8022|162|I|reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) that||
8022|163|I|can increase the risk of bleeding when used with heparin.||
8022|164|I|However, if your doctor has told you to take low-dose aspirin to||
8022|165|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
8022|166|I|you should keep taking the aspirin unless your doctor tells you||
8022|167|I|not to. Ask your doctor or pharmacist for more details.||
8022|168|I|   Cigarette smoking decreases blood levels of this medication.||
8022|169|I|Tell your doctor if you smoke or if you have recently stopped||
8022|170|I|smoking.||
8022|171|I|   This medication may interfere with certain lab tests (such as||
8022|172|I|certain liver function tests, prothrombin time), possibly causing||
8022|173|I|false test results. Make sure lab personnel and all your doctors||
8022|174|I|know you use this drug.||
8022|175|B|||
8022|176|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8022|177|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8022|178|O|poison control center right away. US residents can call||
8022|179|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8022|180|O|Symptoms of overdose may include: easy/unusual bruising,||
8022|181|O|easy/unusual bleeding (such as frequent nosebleeds), blood in||
8022|182|O|urine, black stools.||
8022|183|B|||
8022|184|N|NOTES:  Do not share this medication with others.||
8022|185|N|   Lab and/or medical tests (such as complete blood count,||
8022|186|N|activated partial thromboplastin time, potassium blood level)||
8022|187|N|should be done before you start using this medication and while||
8022|188|N|you are using it. Keep all medical and lab appointments. Consult||
8022|189|N|your doctor for more details.||
8022|190|B|||
8022|191|D|MISSED DOSE:  It is important to get each dose of this medication||
8022|192|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8022|193|D|right away for a new dosing schedule. Do not double the dose to||
8022|194|D|catch up.||
8022|195|B|||
8022|196|R|STORAGE:  Consult the product instructions and your pharmacist||
8022|197|R|for storage details. Keep all medications away from children and||
8022|198|R|pets.||
8022|199|R|   Do not flush medications down the toilet or pour them into a||
8022|200|R|drain unless instructed to do so. Properly discard this product||
8022|201|R|when it is expired or no longer needed. Consult your pharmacist||
8022|202|R|or local waste disposal company.||
8022|203|B|||
8022|204|M|MEDICAL ALERT:  Your condition can cause complications in a||
8022|205|M|medical emergency. For information about enrolling in MedicAlert,||
8022|206|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8022|207|B|||
8022|208|A|Information last revised December 2024.||
8022|209|A|Copyright(c) 2025 First Databank, Inc.||
8022|210|B|||
8023|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8023|002|Z|does NOT have all possible information about this product. This||
8023|003|Z|information does not assure that this product is safe, effective,||
8023|004|Z|or appropriate for you. This information is not individual||
8023|005|Z|medical advice and does not substitute for the advice of your||
8023|006|Z|health care professional. Always ask your health care||
8023|007|Z|professional for complete information about this product and your||
8023|008|Z|specific health needs.||
8023|009|B|||
8023|010|T|DIGOXIN - ORAL||
8023|011|F|(didge-OX-in)||
8023|012|B|||
8023|013|C|COMMON BRAND NAME(S): Lanoxicaps, Lanoxin||
8023|014|B|||
8023|015|U|USES:  Digoxin is used to treat heart failure, usually along with||
8023|016|U|other medications. It is also used to treat certain types of||
8023|017|U|irregular heartbeat (such as chronic atrial fibrillation).||
8023|018|U|Treating heart failure may help maintain your ability to walk and||
8023|019|U|exercise and may improve the strength of your heart. Treating an||
8023|020|U|irregular heartbeat can also improve your ability to exercise.||
8023|021|U|   Digoxin belongs to a class of medications called cardiac||
8023|022|U|glycosides. It works by affecting certain minerals (sodium and||
8023|023|U|potassium) inside heart cells. This reduces strain on the heart||
8023|024|U|and helps it maintain a normal, steady, and strong heartbeat.||
8023|025|B|||
8023|026|H|HOW TO USE:  Take this medication by mouth with or without food||
8023|027|H|as directed by your doctor, usually once daily. If you are using||
8023|028|H|the liquid form of this medication, carefully measure the dose||
8023|029|H|using the dropper provided by the manufacturer. Do not use a||
8023|030|H|household spoon because you may not get the correct dose.||
8023|031|H|   Your body may not absorb this drug as well if you also eat||
8023|032|H|foods that are high in fiber or if you take certain medications.||
8023|033|H|Take this medication at least 2 hours before or after eating food||
8023|034|H|products that are high in fiber (such as bran). If you are also||
8023|035|H|taking cholestyramine, colestipol, or psyllium, wait at least 2||
8023|036|H|hours after taking your digoxin dose before taking any of these||
8023|037|H|products. If you are taking antacids, kaolin-pectin, milk of||
8023|038|H|magnesia, metoclopramide, sulfasalazine, or aminosalicylic acid,||
8023|039|H|take them as far apart from your digoxin dose as possible. Ask||
8023|040|H|your pharmacist if you are not sure when to take any of your||
8023|041|H|medications.||
8023|042|H|   The dosage of this medication is based on your medical||
8023|043|H|condition, age, body weight, lab tests, and response to||
8023|044|H|treatment.||
8023|045|H|   Use this medication regularly to get the most benefit from it.||
8023|046|H|To help you remember, use it at the same time each day. Do not||
8023|047|H|stop taking this medication without consulting your doctor. Some||
8023|048|H|conditions may become worse when the drug is suddenly stopped.||
8023|049|H|   Tell your doctor if your condition does not get better or if||
8023|050|H|it gets worse.||
8023|051|B|||
8023|052|S|SIDE EFFECTS:  Nausea, vomiting, headache, dizziness, loss of||
8023|053|S|appetite, and diarrhea may occur. If any of these effects last or||
8023|054|S|get worse, tell your doctor or pharmacist promptly.||
8023|055|S|   Remember that this medication has been prescribed because your||
8023|056|S|doctor has judged that the benefit to you is greater than the||
8023|057|S|risk of side effects. Many people using this medication do not||
8023|058|S|have serious side effects.||
8023|059|S|   Tell your doctor right away if you have any serious side||
8023|060|S|effects, including: weakness, mental/mood changes, vision changes||
8023|061|S|(such as blurred or yellow/green vision), enlarged/tender breasts||
8023|062|S|in men.||
8023|063|S|   Though this medication is used to treat a certain type of||
8023|064|S|irregular heartbeat, it may rarely cause other types of irregular||
8023|065|S|heartbeats. Tell your doctor right away if you notice any||
8023|066|S|unusually fast/slow/irregular heartbeat.||
8023|067|S|   A very serious allergic reaction to this drug is rare.||
8023|068|S|However, get medical help right away if you notice any symptoms||
8023|069|S|of a serious allergic reaction, including: rash, itching/swelling||
8023|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8023|071|S|breathing.||
8023|072|S|   This is not a complete list of possible side effects. If you||
8023|073|S|notice other effects not listed above, contact your doctor or||
8023|074|S|pharmacist.||
8023|075|S|   In the US -||
8023|076|S|   Call your doctor for medical advice about side effects. You||
8023|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8023|078|S|www.fda.gov/medwatch.||
8023|079|S|   In Canada - Call your doctor for medical advice about side||
8023|080|S|effects. You may report side effects to Health Canada at||
8023|081|S|1-866-234-2345.||
8023|082|B|||
8023|083|P|PRECAUTIONS:  Before taking digoxin, tell your doctor or||
8023|084|P|pharmacist if you are allergic to it; or to similar drugs (such||
8023|085|P|as digitoxin); or if you have any other allergies. This product||
8023|086|P|may contain inactive ingredients, which can cause allergic||
8023|087|P|reactions or other problems. Talk to your pharmacist for more||
8023|088|P|details.||
8023|089|P|   Before using this medication, tell your doctor or pharmacist||
8023|090|P|your medical history, especially of: kidney problems, thyroid||
8023|091|P|problems (underactive or overactive).||
8023|092|P|   This drug may make you dizzy or blur your vision. Alcohol or||
8023|093|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
8023|094|P|machinery, or do anything that needs alertness or clear vision||
8023|095|P|until you can do it safely. Limit alcoholic beverages. Talk to||
8023|096|P|your doctor if you are using marijuana (cannabis).||
8023|097|P|   The balance of certain natural minerals in your blood||
8023|098|P|(calcium, magnesium, potassium) can affect how this drug works in||
8023|099|P|your body. Certain drugs such as "water pills" (diuretics) may||
8023|100|P|affect the normal balance of these minerals. Tell your doctor or||
8023|101|P|pharmacist if you are taking a "water pill" or if you have a||
8023|102|P|history of mineral imbalance. Ask your doctor or pharmacist||
8023|103|P|whether you should take a nutritional supplement or follow a||
8023|104|P|special diet.||
8023|105|P|   Before having surgery or certain procedures on your heart||
8023|106|P|(such as electrical cardioversion), tell your doctor or dentist||
8023|107|P|about all the products you use (including prescription drugs,||
8023|108|P|nonprescription drugs, and herbal products).||
8023|109|P|   Infants and children may be more sensitive to the effects of||
8023|110|P|this drug, especially the effects on the heartbeat.||
8023|111|P|   During pregnancy, this medication should be used only when||
8023|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
8023|113|P|   Digoxin passes into breast milk, but is unlikely to harm a||
8023|114|P|nursing infant. Consult your doctor before breastfeeding.||
8023|115|B|||
8023|116|I|DRUG INTERACTIONS:  See also How to Use section.||
8023|117|I|   Drug interactions may change how your medications work or||
8023|118|I|increase your risk for serious side effects. This document does||
8023|119|I|not contain all possible drug interactions. Keep a list of all||
8023|120|I|the products you use (including prescription/nonprescription||
8023|121|I|drugs and herbal products) and share it with your doctor and||
8023|122|I|pharmacist. Do not start, stop, or change the dosage of any||
8023|123|I|medicines without your doctor's approval.||
8023|124|I|   Other medications can affect the removal of digoxin from your||
8023|125|I|body, which may affect how digoxin works. Examples include azole||
8023|126|I|antifungals (such as itraconazole), dronedarone, lapatinib,||
8023|127|I|macrolide antibiotics (such as clarithromycin, erythromycin),||
8023|128|I|propafenone, St. John's wort, among others.||
8023|129|I|   Some products have ingredients that could worsen your heart||
8023|130|I|failure. Tell your pharmacist what products you are using, and||
8023|131|I|ask how to use them safely (especially cough-and-cold products,||
8023|132|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
8023|133|B|||
8023|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8023|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8023|136|O|poison control center right away. US residents can call||
8023|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8023|138|B|||
8023|139|N|NOTES:  Do not share this medication with others.||
8023|140|N|   Lab and/or medical tests (such as digoxin levels, mineral||
8023|141|N|levels in the blood, kidney function, electrocardiograms) should||
8023|142|N|be done while you are taking this medication. Keep all medical||
8023|143|N|and lab appointments. Consult your doctor for more details.||
8023|144|N|   Check your blood pressure and pulse (heart rate) regularly||
8023|145|N|while taking this medication. Learn how to check your own blood||
8023|146|N|pressure and pulse at home, and share the results with your||
8023|147|N|doctor.||
8023|148|B|||
8023|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8023|150|D|remember. If it is more than 12 hours after the missed dose, skip||
8023|151|D|the missed dose. Take your next dose at the regular time. Do not||
8023|152|D|double the dose to catch up. If you miss more than 2 doses in a||
8023|153|D|row, ask your doctor or pharmacist right away for a new dosing||
8023|154|D|schedule.||
8023|155|B|||
8023|156|R|STORAGE:  Store at room temperature away from light and moisture.||
8023|157|R|Do not store in the bathroom. Keep all medications away from||
8023|158|R|children and pets.||
8023|159|R|   Do not flush medications down the toilet or pour them into a||
8023|160|R|drain unless instructed to do so. Properly discard this product||
8023|161|R|when it is expired or no longer needed. Consult your pharmacist||
8023|162|R|or local waste disposal company.||
8023|163|B|||
8023|164|A|Information last revised January 2025.||
8023|165|A|Copyright(c) 2025 First Databank, Inc.||
8023|166|B|||
8024|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8024|002|Z|does NOT have all possible information about this product. This||
8024|003|Z|information does not assure that this product is safe, effective,||
8024|004|Z|or appropriate for you. This information is not individual||
8024|005|Z|medical advice and does not substitute for the advice of your||
8024|006|Z|health care professional. Always ask your health care||
8024|007|Z|professional for complete information about this product and your||
8024|008|Z|specific health needs.||
8024|009|B|||
8024|010|T|GUANFACINE - ORAL||
8024|011|F|(GWAN-fuh-seen)||
8024|012|B|||
8024|013|C|COMMON BRAND NAME(S): Tenex||
8024|014|B|||
8024|015|U|USES:  This medication is used alone or with other medications to||
8024|016|U|treat high blood pressure (hypertension). Lowering high blood||
8024|017|U|pressure helps prevent strokes, heart attacks, and kidney||
8024|018|U|problems. Guanfacine acts in the brain. It decreases certain||
8024|019|U|nerve signals from the brain to the blood vessels and the heart.||
8024|020|U|This causes the blood vessels to relax so that blood can flow||
8024|021|U|more easily and also slows the heart rate. These effects help to||
8024|022|U|lower blood pressure.||
8024|023|B|||
8024|024|V|OTHER USES:  This section contains uses of this drug that are not||
8024|025|V|listed in the approved professional labeling for the drug but||
8024|026|V|that may be prescribed by your health care professional. Use this||
8024|027|V|drug for a condition that is listed in this section only if it||
8024|028|V|has been so prescribed by your health care professional.||
8024|029|V|   This drug may also be used for attention-deficit/hyperactivity||
8024|030|V|disorder (ADHD).||
8024|031|B|||
8024|032|H|HOW TO USE:  Take this medication by mouth with or without food||
8024|033|H|as directed by your doctor, usually once daily at bedtime.||
8024|034|H|   The dosage is based on your medical condition, response to||
8024|035|H|treatment, and other medications you may be taking. Be sure to||
8024|036|H|tell your doctor and pharmacist about all the products you use||
8024|037|H|(including prescription drugs, nonprescription drugs, and herbal||
8024|038|H|products).||
8024|039|H|   Use this medication regularly to get the most benefit from it.||
8024|040|H|To help you remember, take it at the same time each day.||
8024|041|H|   It may take several weeks before you get the full benefit of||
8024|042|H|this medication. Keep taking this medication even if you feel||
8024|043|H|well. Most people with high blood pressure do not feel sick.||
8024|044|H|   Do not stop taking this medication without consulting your||
8024|045|H|doctor. Some conditions may become worse when this drug is||
8024|046|H|suddenly stopped. Also, you may experience symptoms such as||
8024|047|H|headache, nervousness, agitation, tremor, fast heartbeat, and||
8024|048|H|high blood pressure. To prevent these symptoms while you are||
8024|049|H|stopping treatment with this drug, your doctor may reduce your||
8024|050|H|dose gradually. Ask your doctor or pharmacist for more details.||
8024|051|H|Report any new or worsening symptoms right away.||
8024|052|H|   Tell your doctor if your condition does not get better or if||
8024|053|H|it gets worse (your blood pressure readings remain high or||
8024|054|H|increase).||
8024|055|B|||
8024|056|S|SIDE EFFECTS:  Dry mouth, drowsiness, dizziness, constipation,||
8024|057|S|tiredness, and weakness may occur. Decreased sexual ability has||
8024|058|S|been reported rarely. If any of these effects last or get worse,||
8024|059|S|tell your doctor or pharmacist promptly.||
8024|060|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
8024|061|S|chips, chew (sugarless) gum, drink water, or use a saliva||
8024|062|S|substitute.||
8024|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
8024|064|S|slowly when rising from a sitting or lying position.||
8024|065|S|   Remember that this medication has been prescribed because your||
8024|066|S|doctor has judged that the benefit to you is greater than the||
8024|067|S|risk of side effects. Many people using this medication do not||
8024|068|S|have serious side effects.||
8024|069|S|   Tell your doctor right away if you have any serious side||
8024|070|S|effects, including: fast/slow heartbeat, fainting, mental/mood||
8024|071|S|changes (such as depression, hallucinations, confusion, thoughts||
8024|072|S|of suicide).||
8024|073|S|   A very serious allergic reaction to this drug is rare.||
8024|074|S|However, get medical help right away if you notice any symptoms||
8024|075|S|of a serious allergic reaction, including: rash, itching/swelling||
8024|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8024|077|S|breathing.||
8024|078|S|   This is not a complete list of possible side effects. If you||
8024|079|S|notice other effects not listed above, contact your doctor or||
8024|080|S|pharmacist.||
8024|081|S|   In the US -||
8024|082|S|   Call your doctor for medical advice about side effects. You||
8024|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8024|084|S|www.fda.gov/medwatch.||
8024|085|S|   In Canada - Call your doctor for medical advice about side||
8024|086|S|effects. You may report side effects to Health Canada at||
8024|087|S|1-866-234-2345.||
8024|088|B|||
8024|089|P|PRECAUTIONS:  Before taking guanfacine, tell your doctor or||
8024|090|P|pharmacist if you are allergic to it; or if you have any other||
8024|091|P|allergies. This product may contain inactive ingredients, which||
8024|092|P|can cause allergic reactions or other problems. Talk to your||
8024|093|P|pharmacist for more details.||
8024|094|P|   Before using this medication, tell your doctor or pharmacist||
8024|095|P|your medical history, especially of: kidney disease, liver||
8024|096|P|disease, personal/family history of mental/mood disorders (such||
8024|097|P|as bipolar disorder, depression, suicidal thoughts).||
8024|098|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8024|099|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8024|100|P|machinery, or do anything that needs alertness until you can do||
8024|101|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8024|102|P|are using marijuana (cannabis).||
8024|103|P|   Before having surgery, tell your doctor or dentist about all||
8024|104|P|the products you use (including prescription drugs,||
8024|105|P|nonprescription drugs, and herbal products).||
8024|106|P|   Children may be more sensitive to the side effects of this||
8024|107|P|drug, especially hallucinations and mental/mood changes.||
8024|108|P|   Older adults may be more sensitive to the side effects of this||
8024|109|P|drug, especially dizziness (more likely when standing up),||
8024|110|P|drowsiness, slow heartbeat, or depression. Dizziness and||
8024|111|P|drowsiness can increase the risk of falling.||
8024|112|P|   During pregnancy, this medication should be used only when||
8024|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
8024|114|P|   It is unknown if this medication passes into breast milk.||
8024|115|P|Consult your doctor before breastfeeding.||
8024|116|B|||
8024|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8024|118|I|medications work or increase your risk for serious side effects.||
8024|119|I|This document does not contain all possible drug interactions.||
8024|120|I|Keep a list of all the products you use (including||
8024|121|I|prescription/nonprescription drugs and herbal products) and share||
8024|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
8024|123|I|the dosage of any medicines without your doctor's approval.||
8024|124|I|   Tell your doctor or pharmacist if you are taking other||
8024|125|I|products that cause drowsiness including alcohol, marijuana||
8024|126|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
8024|127|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
8024|128|I|zolpidem), muscle relaxants (such as carisoprodol,||
8024|129|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
8024|130|I|hydrocodone).||
8024|131|I|   Check the labels on all your medicines (such as cough-and-cold||
8024|132|I|products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs||
8024|133|I|such as ibuprofen for pain/fever reduction) because they may||
8024|134|I|contain ingredients that cause drowsiness or could increase your||
8024|135|I|blood pressure or heart rate. Ask your pharmacist about using||
8024|136|I|those products safely.||
8024|137|B|||
8024|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8024|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8024|140|O|poison control center right away. US residents can call||
8024|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8024|142|O|Symptoms of overdose may include: severe drowsiness, severe||
8024|143|O|dizziness, severe tiredness, very slow heartbeat.||
8024|144|B|||
8024|145|N|NOTES:  Do not share this medication with others.||
8024|146|N|   Talk with your doctor about making changes to your lifestyle||
8024|147|N|that may help this medication work better (such as stress||
8024|148|N|reduction programs, exercise, and dietary changes).||
8024|149|N|   Have your blood pressure and heart rate checked regularly||
8024|150|N|while taking this medication. Learn how to check your own blood||
8024|151|N|pressure and heart rate at home, and share the results with your||
8024|152|N|doctor.||
8024|153|B|||
8024|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8024|155|D|remember. If it is near the time of the next dose, skip the||
8024|156|D|missed dose. Take your next dose at the regular time. Do not||
8024|157|D|double the dose to catch up.||
8024|158|B|||
8024|159|R|STORAGE:  Store at room temperature away from light and moisture.||
8024|160|R|Do not store in the bathroom. Keep all medications away from||
8024|161|R|children and pets.||
8024|162|R|   Do not flush medications down the toilet or pour them into a||
8024|163|R|drain unless instructed to do so. Properly discard this product||
8024|164|R|when it is expired or no longer needed. Consult your pharmacist||
8024|165|R|or local waste disposal company.||
8024|166|B|||
8024|167|A|Information last revised May 2024.||
8024|168|A|Copyright(c) 2025 First Databank, Inc.||
8024|169|B|||
8028|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8028|002|Z|does NOT have all possible information about this product. This||
8028|003|Z|information does not assure that this product is safe, effective,||
8028|004|Z|or appropriate for you. This information is not individual||
8028|005|Z|medical advice and does not substitute for the advice of your||
8028|006|Z|health care professional. Always ask your health care||
8028|007|Z|professional for complete information about this product and your||
8028|008|Z|specific health needs.||
8028|009|B|||
8028|010|T|RIFABUTIN - ORAL||
8028|011|F|(rye-fuh-BYOU-tin)||
8028|012|B|||
8028|013|C|COMMON BRAND NAME(S): Mycobutin||
8028|014|B|||
8028|015|U|USES:  This medication is used alone or with another medication||
8028|016|U|to help prevent a certain serious infection (Mycobacterium avium||
8028|017|U|complex-MAC). Rifabutin is known as a rifamycin antibiotic. It||
8028|018|U|works by stopping the growth of bacteria.||
8028|019|U|   This antibiotic treats and prevents only bacterial infections.||
8028|020|U|It will not work for viral infections (such as common cold, flu).||
8028|021|U|Using any antibiotic when it is not needed can cause it to not||
8028|022|U|work for future infections.||
8028|023|B|||
8028|024|V|OTHER USES:  This section contains uses of this drug that are not||
8028|025|V|listed in the approved professional labeling for the drug but||
8028|026|V|that may be prescribed by your health care professional. Use this||
8028|027|V|drug for a condition that is listed in this section only if it||
8028|028|V|has been so prescribed by your health care professional.||
8028|029|V|   This drug may also be used for active MAC infection or active||
8028|030|V|tuberculosis (TB) infection. It may also be used to reduce the||
8028|031|V|risk of active TB infections in people who may be infected with||
8028|032|V|the bacteria (people with positive TB skin test).||
8028|033|B|||
8028|034|H|HOW TO USE:  Take this medication by mouth with or without food||
8028|035|H|as directed by your doctor, usually once or twice daily. Take||
8028|036|H|this medication with food if stomach upset occurs. For the||
8028|037|H|treatment of tuberculosis, this drug is sometimes taken twice||
8028|038|H|weekly.||
8028|039|H|   The dosage is based on your medical condition, weight,||
8028|040|H|response to treatment, and other medications you may be taking.||
8028|041|H|Be sure to tell your doctor and pharmacist about all the products||
8028|042|H|you use (including prescription drugs, nonprescription drugs, and||
8028|043|H|herbal products).||
8028|044|H|   For the best effect, take this antibiotic at evenly spaced||
8028|045|H|times. To help you remember, take this medication at the same||
8028|046|H|time(s) every day.||
8028|047|H|   Continue to take this medication until the full prescribed||
8028|048|H|amount is finished, even if symptoms disappear. Stopping the||
8028|049|H|medication too early or skipping doses may result in a return of||
8028|050|H|the infection and cause the infection to be more difficult to||
8028|051|H|treat (resistant).||
8028|052|H|   Tell your doctor if your condition lasts or gets worse.||
8028|053|B|||
8028|054|S|SIDE EFFECTS:  Diarrhea, stomach upset, changes in taste, or||
8028|055|S|nausea/vomiting may occur. If any of these effects last or get||
8028|056|S|worse, tell your doctor or pharmacist promptly.||
8028|057|S|   This medication may cause urine, sweat, saliva, or tears to||
8028|058|S|turn brown-orange. This effect is harmless and will disappear||
8028|059|S|when the medication is stopped. However, dentures and contact||
8028|060|S|lenses may be permanently stained.||
8028|061|S|   Remember that this medication has been prescribed because your||
8028|062|S|doctor has judged that the benefit to you is greater than the||
8028|063|S|risk of side effects. Many people using this medication do not||
8028|064|S|have serious side effects.||
8028|065|S|   Tell your doctor right away if you have any serious side||
8028|066|S|effects, including: nausea/vomiting that doesn't stop, easy||
8028|067|S|bleeding/bruising, muscle weakness/pain, joint pain/swelling, eye||
8028|068|S|pain/redness, vision problems, chest pain/pressure, unusual||
8028|069|S|weakness/tiredness, dark urine, yellowing eyes/skin.||
8028|070|S|   This medication may rarely cause a severe intestinal condition||
8028|071|S|due to a bacteria called C. difficile. This condition may occur||
8028|072|S|during treatment or weeks to months after treatment has stopped.||
8028|073|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8028|074|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8028|075|S|stool.||
8028|076|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8028|077|S|products because they may make symptoms worse.||
8028|078|S|   A very serious allergic reaction to this drug is rare.||
8028|079|S|However, get medical help right away if you notice any symptoms||
8028|080|S|of a serious allergic reaction, including: fever that doesn't go||
8028|081|S|away, new or worsening lymph node swelling, rash,||
8028|082|S|itching/swelling (especially of the face/tongue/throat), severe||
8028|083|S|dizziness, trouble breathing.||
8028|084|S|   This is not a complete list of possible side effects. If you||
8028|085|S|notice other effects not listed above, contact your doctor or||
8028|086|S|pharmacist.||
8028|087|S|   In the US -||
8028|088|S|   Call your doctor for medical advice about side effects. You||
8028|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8028|090|S|www.fda.gov/medwatch.||
8028|091|S|   In Canada - Call your doctor for medical advice about side||
8028|092|S|effects. You may report side effects to Health Canada at||
8028|093|S|1-866-234-2345.||
8028|094|B|||
8028|095|P|PRECAUTIONS:  Before taking rifabutin, tell your doctor or||
8028|096|P|pharmacist if you are allergic to it; or to other rifamycins||
8028|097|P|(such as rifampin); or if you have any other allergies. This||
8028|098|P|product may contain inactive ingredients, which can cause||
8028|099|P|allergic reactions or other problems. Talk to your pharmacist for||
8028|100|P|more details.||
8028|101|P|   Before using this medication, tell your doctor or pharmacist||
8028|102|P|your medical history, especially of: kidney disease, liver||
8028|103|P|disease, a certain blood disorder (porphyria).||
8028|104|P|   Before having surgery, tell your doctor or dentist about all||
8028|105|P|the products you use (including prescription drugs,||
8028|106|P|nonprescription drugs, and herbal products).||
8028|107|P|   Rifabutin may cause live bacterial vaccines (such as typhoid||
8028|108|P|vaccine) to not work well. Tell your health care professional||
8028|109|P|that you are using rifabutin before having any||
8028|110|P|immunizations/vaccinations.||
8028|111|P|   During pregnancy, this medication should be used only when||
8028|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
8028|113|P|   It is unknown if this medication passes into breast milk. If||
8028|114|P|you have HIV, breast milk may transmit HIV. Consult your doctor||
8028|115|P|before breastfeeding.||
8028|116|B|||
8028|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8028|118|I|medications work or increase your risk for serious side effects.||
8028|119|I|This document does not contain all possible drug interactions.||
8028|120|I|Keep a list of all the products you use (including||
8028|121|I|prescription/nonprescription drugs and herbal products) and share||
8028|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
8028|123|I|the dosage of any medicines without your doctor's approval.||
8028|124|I|   Some products that may interact with this drug include: azole||
8028|125|I|antifungals (such as fluconazole, itraconazole, voriconazole),||
8028|126|I|ciprofloxacin, macrolide antibiotics (such as clarithromycin).||
8028|127|I|   Rifabutin can speed up the removal of other medications from||
8028|128|I|your body, which may affect how they work. Examples of affected||
8028|129|I|drugs include aprepitant/fosaprepitant, lurasidone, mavacamten,||
8028|130|I|phenytoin, ranolazine, suvorexant, tacrolimus, tasimelteon,||
8028|131|I|"blood thinners" (such as warfarin), calcium channel blockers||
8028|132|I|(such as diltiazem, verapamil), among others.||
8028|133|I|   This medication may decrease the effectiveness of hormonal||
8028|134|I|birth control such as pills, patch, or ring. This could cause||
8028|135|I|pregnancy. Discuss with your doctor or pharmacist if you should||
8028|136|I|use reliable backup birth control methods while using this||
8028|137|I|medication. Also tell your doctor if you have any new spotting or||
8028|138|I|breakthrough bleeding, because these may be signs that your birth||
8028|139|I|control is not working well.||
8028|140|B|||
8028|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8028|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8028|143|O|poison control center right away. US residents can call||
8028|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8028|145|B|||
8028|146|N|NOTES:  Do not share this medication with others.||
8028|147|N|   Lab and/or medical tests (such as liver function, complete||
8028|148|N|blood count) should be done while you are taking this medication.||
8028|149|N|Keep all medical and lab appointments. Consult your doctor for||
8028|150|N|more details.||
8028|151|B|||
8028|152|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8028|153|D|remember. If it is near the time of the next dose, skip the||
8028|154|D|missed dose. Take your next dose at the regular time. Do not||
8028|155|D|double the dose to catch up.||
8028|156|B|||
8028|157|R|STORAGE:  Store at room temperature away from light and moisture.||
8028|158|R|Do not store in the bathroom. Keep all medications away from||
8028|159|R|children and pets.||
8028|160|R|   Do not flush medications down the toilet or pour them into a||
8028|161|R|drain unless instructed to do so. Properly discard this product||
8028|162|R|when it is expired or no longer needed. Consult your pharmacist||
8028|163|R|or local waste disposal company.||
8028|164|B|||
8028|165|A|Information last revised March 2025.||
8028|166|A|Copyright(c) 2025 First Databank, Inc.||
8028|167|B|||
8030|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8030|002|Z|does NOT have all possible information about this product. This||
8030|003|Z|information does not assure that this product is safe, effective,||
8030|004|Z|or appropriate for you. This information is not individual||
8030|005|Z|medical advice and does not substitute for the advice of your||
8030|006|Z|health care professional. Always ask your health care||
8030|007|Z|professional for complete information about this product and your||
8030|008|Z|specific health needs.||
8030|009|B|||
8030|010|T|APRACLONIDINE SOLUTION 0.5% - OPHTHALMIC||
8030|011|F|(A-pra-KLON-i-deen)||
8030|012|B|||
8030|013|C|COMMON BRAND NAME(S): Iopidine||
8030|014|B|||
8030|015|U|USES:  Apraclonidine is used along with other medications to||
8030|016|U|treat serious high pressure inside the eye (glaucoma) for a short||
8030|017|U|time (such as 1 month) to help delay or prevent the need for eye||
8030|018|U|surgery. Decreasing high pressure inside the eye may help to||
8030|019|U|prevent decreased vision or blindness. Apraclonidine is thought||
8030|020|U|to work by decreasing the amount of fluid within the eye.||
8030|021|B|||
8030|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
8030|023|H|directed by your doctor, usually 3 times daily.||
8030|024|H|   If you are wearing contact lenses, remove them before using||
8030|025|H|eye drops. Wait at least 15 minutes before replacing your contact||
8030|026|H|lenses.||
8030|027|H|   To apply eye drops, wash your hands first. To avoid||
8030|028|H|contamination, be careful not to touch the dropper tip or let it||
8030|029|H|touch your eye or any other surface.||
8030|030|H|   Tilt your head back, look up, and pull down the lower eyelid||
8030|031|H|to make a pouch. Hold the dropper directly over your eye and||
8030|032|H|place 1 drop into the pouch. Release the eyelid and gently close||
8030|033|H|your eyes. Place one finger at the corner of your eye (near the||
8030|034|H|nose) and apply gentle pressure for 1 to 2 minutes. This will||
8030|035|H|prevent the medication from draining out. Try not to blink and do||
8030|036|H|not rub your eye. Repeat these steps for your other eye if so||
8030|037|H|directed or if your dose is for more than 1 drop.||
8030|038|H|   Remove extra solution around the eye with a tissue and wash||
8030|039|H|your hands to remove any medicine that may be on them.||
8030|040|H|   If you are using another kind of eye medication (such as drops||
8030|041|H|or ointments), wait at least 5 minutes before using the other||
8030|042|H|medication. Use eye drops before ointments to allow the eye drops||
8030|043|H|to enter the eye.||
8030|044|H|   Wait several minutes for your vision to clear before driving||
8030|045|H|or operating machinery.||
8030|046|H|   Dosage is based on your medical condition and response to||
8030|047|H|treatment. Do not increase your dose or use it more often than||
8030|048|H|prescribed. When used for an extended time, this medication may||
8030|049|H|not work as well and may require different dosing. Your doctor||
8030|050|H|will monitor your progress with regular eye exams.||
8030|051|B|||
8030|052|S|SIDE EFFECTS:  Eye discomfort/redness/burning, blurred vision,||
8030|053|S|dry mouth/nose, dizziness, drowsiness, upset stomach, or unusual||
8030|054|S|tiredness may occur. Eye itching/watering or eyelid swelling may||
8030|055|S|be symptoms of an allergic reaction of the eye. If any of these||
8030|056|S|effects last or get worse, tell your doctor or pharmacist||
8030|057|S|promptly.||
8030|058|S|   Remember that this medication has been prescribed because your||
8030|059|S|doctor has judged that the benefit to you is greater than the||
8030|060|S|risk of side effects. Many people using this medication do not||
8030|061|S|have serious side effects.||
8030|062|S|   Tell your doctor right away if you have any serious side||
8030|063|S|effects, including: mental/mood changes (such as depression,||
8030|064|S|irritability), slow/irregular heartbeat.||
8030|065|S|   A very serious allergic reaction to this drug is rare.||
8030|066|S|However, get medical help right away if you notice any symptoms||
8030|067|S|of a serious allergic reaction, including: rash, itching/swelling||
8030|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8030|069|S|breathing.||
8030|070|S|   This is not a complete list of possible side effects. If you||
8030|071|S|notice other effects not listed above, contact your doctor or||
8030|072|S|pharmacist.||
8030|073|S|   In the US -||
8030|074|S|   Call your doctor for medical advice about side effects. You||
8030|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8030|076|S|www.fda.gov/medwatch.||
8030|077|S|   In Canada - Call your doctor for medical advice about side||
8030|078|S|effects. You may report side effects to Health Canada at||
8030|079|S|1-866-234-2345.||
8030|080|B|||
8030|081|P|PRECAUTIONS:  Before using apraclonidine, tell your doctor or||
8030|082|P|pharmacist if you are allergic to it; or to clonidine; or if you||
8030|083|P|have any other allergies. This product may contain inactive||
8030|084|P|ingredients, which can cause allergic reactions or other||
8030|085|P|problems. Talk to your pharmacist for more details.||
8030|086|P|   Before using this medication, tell your doctor or pharmacist||
8030|087|P|your medical history, especially of: blood vessel disease (such||
8030|088|P|as cerebrovascular disease, Raynaud's disease), high blood||
8030|089|P|pressure, heart problems (such as recent heart attack), kidney||
8030|090|P|disease, mental/mood disorders (such as depression).||
8030|091|P|   After you apply this drug, your vision may become temporarily||
8030|092|P|blurred or unstable. This drug may also rarely make you dizzy or||
8030|093|P|drowsy. Alcohol or marijuana (cannabis) can make you more dizzy||
8030|094|P|or drowsy. Do not drive, use machinery, or do anything that needs||
8030|095|P|alertness or clear vision until you can do it safely. Limit||
8030|096|P|alcoholic beverages. Talk to your doctor if you are using||
8030|097|P|marijuana (cannabis).||
8030|098|P|   During pregnancy, this medication should be used only when||
8030|099|P|clearly needed. Discuss the risks and benefits with your doctor.||
8030|100|P|   It is unknown if this medication passes into breast milk.||
8030|101|P|Consult your doctor before breastfeeding.||
8030|102|B|||
8030|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8030|104|I|medications work or increase your risk for serious side effects.||
8030|105|I|This document does not contain all possible drug interactions.||
8030|106|I|Keep a list of all the products you use (including||
8030|107|I|prescription/nonprescription drugs and herbal products) and share||
8030|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
8030|109|I|the dosage of any medicines without your doctor's approval.||
8030|110|I|   Taking MAO inhibitors with this medication may cause a serious||
8030|111|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
8030|112|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8030|113|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8030|114|I|selegiline, tranylcypromine) during treatment with this||
8030|115|I|medication. Most MAO inhibitors should also not be taken for two||
8030|116|I|weeks before treatment with this medication. Ask your doctor when||
8030|117|I|to start or stop taking this medication.||
8030|118|I|   Tell your doctor or pharmacist if you are taking other||
8030|119|I|products that cause drowsiness including alcohol, marijuana||
8030|120|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
8030|121|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
8030|122|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
8030|123|I|codeine).||
8030|124|I|   Check the labels on all your medicines (such as cough-and-cold||
8030|125|I|products) because they may contain ingredients that may cause||
8030|126|I|drowsiness. Ask your pharmacist about using those products||
8030|127|I|safely.||
8030|128|B|||
8030|129|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8030|130|O|has overdosed and has serious symptoms such as passing out or||
8030|131|O|trouble breathing, call 911. Otherwise, call a poison control||
8030|132|O|center right away. US residents can call 1-800-222-1222. Canada||
8030|133|O|residents can call 1-844-764-7669. Symptoms of overdose may||
8030|134|O|include: slow heartbeat, drowsiness, cold/clammy skin.||
8030|135|B|||
8030|136|N|NOTES:  Do not share this medication with others.||
8030|137|N|   Lab and/or medical tests (such as pulse, blood pressure, eye||
8030|138|N|exams) may be done while you are using this medication. Keep all||
8030|139|N|medical and lab appointments. Consult your doctor for more||
8030|140|N|details.||
8030|141|B|||
8030|142|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8030|143|D|If it is near the time of the next dose, skip the missed dose.||
8030|144|D|Use your next dose at the regular time. Do not double the dose to||
8030|145|D|catch up.||
8030|146|B|||
8030|147|R|STORAGE:  Store in the refrigerator or at room temperature away||
8030|148|R|from light. Do not freeze. Keep all medications away from||
8030|149|R|children and pets.||
8030|150|R|   Do not flush medications down the toilet or pour them into a||
8030|151|R|drain unless instructed to do so. Properly discard this product||
8030|152|R|when it is expired or no longer needed. Consult your pharmacist||
8030|153|R|or local waste disposal company.||
8030|154|B|||
8030|155|A|Information last revised May 2024.||
8030|156|A|Copyright(c) 2025 First Databank, Inc.||
8030|157|B|||
8031|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8031|002|Z|does NOT have all possible information about this product. This||
8031|003|Z|information does not assure that this product is safe, effective,||
8031|004|Z|or appropriate for you. This information is not individual||
8031|005|Z|medical advice and does not substitute for the advice of your||
8031|006|Z|health care professional. Always ask your health care||
8031|007|Z|professional for complete information about this product and your||
8031|008|Z|specific health needs.||
8031|009|B|||
8031|010|T|ECHOTHIOPHATE SOLUTION - OPHTHALMIC||
8031|011|F|(eck-oh-THIGH-oh-fate)||
8031|012|B|||
8031|013|C|COMMON BRAND NAME(S): Phospholine Iodide||
8031|014|B|||
8031|015|U|USES:  This medication is used to treat high pressure inside the||
8031|016|U|eye (due to conditions such as certain types of glaucoma) and||
8031|017|U|other eye problems (such as accommodative esotropia). It works by||
8031|018|U|causing the pupil to shrink, decreasing the amount of fluid||
8031|019|U|within the eye, and affecting certain eye muscles.||
8031|020|B|||
8031|021|H|HOW TO USE:  Use this medication in the affected eye(s) as||
8031|022|H|directed by your doctor, usually once or twice a day.||
8031|023|H|   To apply eye drops, wash your hands first. To avoid||
8031|024|H|contamination, do not touch the dropper tip or let it touch your||
8031|025|H|eye or any other surface.||
8031|026|H|   If you are wearing contact lenses, remove them before using||
8031|027|H|eye drops. Wait at least 15 minutes before replacing your contact||
8031|028|H|lenses.||
8031|029|H|   Tilt your head back, look upward, and pull down the lower||
8031|030|H|eyelid to make a pouch. Hold the dropper directly over your eye||
8031|031|H|and place one drop into the pouch. Let go of the eyelid and||
8031|032|H|gently close your eyes. Place one finger at the corner of your||
8031|033|H|eye (near the nose) and apply gentle pressure for 1 to 2 minutes.||
8031|034|H|This will prevent the medication from draining out. Try not to||
8031|035|H|blink and do not rub your eye. Repeat these steps for your other||
8031|036|H|eye if so directed or if your dose is for more than 1 drop.||
8031|037|H|   Remove extra solution around the eye with a tissue, and wash||
8031|038|H|your hands to remove any medicine that may be on them. Do not||
8031|039|H|rinse the dropper. Replace the dropper cap after each use.||
8031|040|H|   If you are using another kind of eye medication (such as drops||
8031|041|H|or ointments), wait at least 5 minutes before using the other||
8031|042|H|medication. Use eye drops before ointments to allow the eye drops||
8031|043|H|to enter the eye.||
8031|044|H|   Wait several minutes for your vision to clear before driving||
8031|045|H|or operating machinery.||
8031|046|H|   The dosage is based on your medical condition and response to||
8031|047|H|treatment. Do not increase your dose or use more often than||
8031|048|H|directed by your doctor. Doing so may increase the risk for||
8031|049|H|serious side effects.||
8031|050|B|||
8031|051|S|SIDE EFFECTS:  Temporary irritation/burning/stinging of the eye,||
8031|052|S|temporary blurred vision, eyelid muscle twitching, poor vision in||
8031|053|S|dim light, headache, or brow ache may occur. If any of these||
8031|054|S|effects last or get worse, tell your doctor or pharmacist||
8031|055|S|promptly.||
8031|056|S|   Remember that this medication has been prescribed because your||
8031|057|S|doctor has judged that the benefit to you is greater than the||
8031|058|S|risk of side effects. Many people using this medication do not||
8031|059|S|have serious side effects.||
8031|060|S|   Tell your doctor right away if you have any serious side||
8031|061|S|effects, including: eye pain, flushing, diarrhea, nausea,||
8031|062|S|irregular heartbeat, stomach/abdominal pain or cramps, increased||
8031|063|S|saliva, increased urination, unusual sweating, vision changes.||
8031|064|S|   A very serious allergic reaction to this drug is rare.||
8031|065|S|However, get medical help right away if you notice any symptoms||
8031|066|S|of a serious allergic reaction, including: rash, itching/swelling||
8031|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8031|068|S|breathing.||
8031|069|S|   This is not a complete list of possible side effects. If you||
8031|070|S|notice other effects not listed above, contact your doctor or||
8031|071|S|pharmacist.||
8031|072|S|   In the US -||
8031|073|S|   Call your doctor for medical advice about side effects. You||
8031|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8031|075|S|www.fda.gov/medwatch.||
8031|076|S|   In Canada - Call your doctor for medical advice about side||
8031|077|S|effects. You may report side effects to Health Canada at||
8031|078|S|1-866-234-2345.||
8031|079|B|||
8031|080|P|PRECAUTIONS:  Before using echothiophate, tell your doctor or||
8031|081|P|pharmacist if you are allergic to it; or if you have any other||
8031|082|P|allergies. This product may contain inactive ingredients, which||
8031|083|P|can cause allergic reactions or other problems. Talk to your||
8031|084|P|pharmacist for more details.||
8031|085|P|   Before using this medication, tell your doctor or pharmacist||
8031|086|P|your medical history, especially of: asthma, epilepsy, other eye||
8031|087|P|problems (such as iritis, uveitis, detached retina), heart||
8031|088|P|disease (such as heart failure, recent heart attack), low or high||
8031|089|P|blood pressure, myasthenia gravis, overactive thyroid||
8031|090|P|(hyperthyroidism), Parkinsonism, stomach/intestinal problems||
8031|091|P|(such as ulcers, spasms), certain urinary problems (such as||
8031|092|P|blockage).||
8031|093|P|   After you apply this drug, your vision may become temporarily||
8031|094|P|blurred or unstable. Vision in dim light may be affected. Do not||
8031|095|P|drive (especially at night), use machinery, or do anything that||
8031|096|P|needs clear vision until you can do it safely.||
8031|097|P|   Avoid exposure to insecticides. Some types of insecticides may||
8031|098|P|increase the risk of certain side effects. If you have contact||
8031|099|P|with insecticides, wear a mask and/or gloves and wash or change||
8031|100|P|clothing often. Consult your doctor or pharmacist for more||
8031|101|P|information.||
8031|102|P|   Before having surgery, tell your doctor or dentist about all||
8031|103|P|the products you use (including prescription drugs,||
8031|104|P|nonprescription drugs, and herbal products).||
8031|105|P|   During pregnancy, this medication should be used only when||
8031|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
8031|107|P|   It is unknown if this drug passes into breast milk. Consult||
8031|108|P|your doctor before breastfeeding.||
8031|109|B|||
8031|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8031|111|I|medications work or increase your risk for serious side effects.||
8031|112|I|This document does not contain all possible drug interactions.||
8031|113|I|Keep a list of all the products you use (including||
8031|114|I|prescription/nonprescription drugs and herbal products) and share||
8031|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
8031|116|I|the dosage of any medicines without your doctor's approval.||
8031|117|B|||
8031|118|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8031|119|O|has overdosed and has serious symptoms such as passing out or||
8031|120|O|trouble breathing, call 911. Otherwise, call a poison control||
8031|121|O|center right away. US residents can call 1-800-222-1222. Canada||
8031|122|O|residents can call 1-844-764-7669. Symptoms of overdose may||
8031|123|O|include: increased saliva, irregular/slow heartbeat, nausea,||
8031|124|O|diarrhea, increased sweating.||
8031|125|B|||
8031|126|N|NOTES:  Do not share this medication with others.||
8031|127|N|   Lab and/or medical tests (such as eye exams) should be done||
8031|128|N|while you are using this medication. Keep all medical and lab||
8031|129|N|appointments. Consult your doctor for more details.||
8031|130|B|||
8031|131|D|MISSED DOSE:  If you are prescribed this medication on a once- or||
8031|132|D|twice-daily schedule and miss a dose, apply it as soon as you||
8031|133|D|remember. If it is near the time of the next dose, skip the||
8031|134|D|missed dose. Use your next dose at the regular time. Do not||
8031|135|D|double the dose to catch up.||
8031|136|D|   Ask your doctor ahead of time what you should do if you miss a||
8031|137|D|dose while using this medication on another schedule besides a||
8031|138|D|daily one.||
8031|139|B|||
8031|140|R|STORAGE:  Store upright at room temperature. Do not refrigerate.||
8031|141|R|Discard any unused portion after 4 weeks. Keep all medications||
8031|142|R|away from children and pets.||
8031|143|R|   Do not flush medications down the toilet or pour them into a||
8031|144|R|drain unless instructed to do so. Properly discard this product||
8031|145|R|when it is expired or no longer needed. Consult your pharmacist||
8031|146|R|or local waste disposal company.||
8031|147|B|||
8031|148|A|Information last revised September 2024.||
8031|149|A|Copyright(c) 2025 First Databank, Inc.||
8031|150|B|||
8034|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8034|002|Z|does NOT have all possible information about this product. This||
8034|003|Z|information does not assure that this product is safe, effective,||
8034|004|Z|or appropriate for you. This information is not individual||
8034|005|Z|medical advice and does not substitute for the advice of your||
8034|006|Z|health care professional. Always ask your health care||
8034|007|Z|professional for complete information about this product and your||
8034|008|Z|specific health needs.||
8034|009|B|||
8034|010|T|LOXAPINE - ORAL||
8034|011|F|(LOX-uh-peen)||
8034|012|B|||
8034|013|C|COMMON BRAND NAME(S): Loxitane||
8034|014|B|||
8034|015|W|WARNING:  There may be a slightly increased risk of serious,||
8034|016|W|possibly fatal side effects (such as heart failure,||
8034|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
8034|018|W|by older adults with dementia. This medication is not approved||
8034|019|W|for the treatment of dementia-related behavior problems. Discuss||
8034|020|W|the risks and benefits of this medication, as well as other||
8034|021|W|effective and possibly safer treatments for dementia-related||
8034|022|W|behavior problems, with the doctor.||
8034|023|B|||
8034|024|U|USES:  This medication is used to treat certain mental/mood||
8034|025|U|disorders (such as schizophrenia). Loxapine belongs to a class of||
8034|026|U|drugs known as antipsychotics. It works by helping to restore the||
8034|027|U|balance of certain natural substances in the brain.||
8034|028|B|||
8034|029|H|HOW TO USE:  Take this medication by mouth with or without food||
8034|030|H|as directed by your doctor, usually 2 to 4 times daily.||
8034|031|H|   If you are using the liquid form of this medication, carefully||
8034|032|H|measure the dose using a special measuring device/dropper and mix||
8034|033|H|it in liquid or soft food (such as applesauce, pudding) just||
8034|034|H|before taking. Do not use a household spoon because you may not||
8034|035|H|get the correct dose.||
8034|036|H|   The dosage is based on your medical condition and response to||
8034|037|H|treatment. To reduce your risk of side effects such as drowsiness||
8034|038|H|and shaking (tremor), your doctor may direct you to start this||
8034|039|H|medication at a low dose and gradually increase your dose. Follow||
8034|040|H|your doctor's directions carefully.||
8034|041|H|   Take this medication regularly to get the most benefit from||
8034|042|H|it. To help you remember, take it at the same time(s) each day.||
8034|043|H|   Although you may notice some improvement in your symptoms soon||
8034|044|H|after starting this medication, it may take several weeks to||
8034|045|H|months before you get the full benefit of this drug.||
8034|046|H|   Do not stop taking this medication without consulting your||
8034|047|H|doctor. Some conditions may become worse when this drug is||
8034|048|H|suddenly stopped. Also, you may experience symptoms such as||
8034|049|H|uncontrolled movements. To prevent these symptoms while you are||
8034|050|H|stopping treatment with this drug, your doctor may reduce your||
8034|051|H|dose gradually. Consult your doctor or pharmacist for more||
8034|052|H|details. Report any new or worsening symptoms right away.||
8034|053|H|   Tell your doctor if your condition does not get better or if||
8034|054|H|it gets worse.||
8034|055|B|||
8034|056|S|SIDE EFFECTS:  See also Warning section.||
8034|057|S|   Drowsiness, dizziness, lightheadedness, constipation, dry||
8034|058|S|mouth, weight gain, or blurred vision may occur. If any of these||
8034|059|S|effects last or get worse, tell your doctor or pharmacist||
8034|060|S|promptly.||
8034|061|S|   Dizziness and lightheadedness can increase the risk of||
8034|062|S|falling. Get up slowly when rising from a sitting or lying||
8034|063|S|position.||
8034|064|S|   Tell your doctor right away if any of these side effects||
8034|065|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
8034|066|S|mask-like expression of the face, drooling/trouble swallowing, or||
8034|067|S|shuffling walk. Your doctor may prescribe another medication to||
8034|068|S|decrease these side effects.||
8034|069|S|   Remember that this medication has been prescribed because your||
8034|070|S|doctor has judged that the benefit to you is greater than the||
8034|071|S|risk of side effects. Many people using this medication do not||
8034|072|S|have serious side effects.||
8034|073|S|   Tell your doctor right away if you have any serious side||
8034|074|S|effects, including: easy bruising/bleeding, fainting,||
8034|075|S|depression/suicidal thoughts, difficulty urinating, signs of||
8034|076|S|infection (such as sore throat that doesn't go away, fever,||
8034|077|S|chills), seizures, severe stomach/abdominal pain.||
8034|078|S|   This medication may cause a condition known as tardive||
8034|079|S|dyskinesia. In some cases, this condition may be permanent. Tell||
8034|080|S|your doctor right away if you develop any involuntary/repetitive||
8034|081|S|muscle movements such as lip smacking/puckering, tongue||
8034|082|S|thrusting, chewing, or finger/toe movements.||
8034|083|S|   In rare cases, loxapine may increase your level of a certain||
8034|084|S|chemical made by the body (prolactin). For females, this increase||
8034|085|S|in prolactin may result in unwanted breast milk, missed/stopped||
8034|086|S|periods, or difficulty becoming pregnant. For males, it may||
8034|087|S|result in decreased sexual ability, inability to produce sperm,||
8034|088|S|or enlarged breasts. If you develop any of these symptoms, tell||
8034|089|S|your doctor right away.||
8034|090|S|   This medication may rarely cause a very serious condition||
8034|091|S|called neuroleptic malignant syndrome (NMS). Get medical help||
8034|092|S|right away if you have any of the following symptoms: fever,||
8034|093|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
8034|094|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
8034|095|S|signs of kidney problems (such as change in the amount of urine).||
8034|096|S|   A very serious allergic reaction to this drug is rare.||
8034|097|S|However, get medical help right away if you notice any symptoms||
8034|098|S|of a serious allergic reaction, including: rash, itching/swelling||
8034|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8034|100|S|breathing.||
8034|101|S|   This is not a complete list of possible side effects. If you||
8034|102|S|notice other effects not listed above, contact your doctor or||
8034|103|S|pharmacist.||
8034|104|S|   In the US -||
8034|105|S|   Call your doctor for medical advice about side effects. You||
8034|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8034|107|S|www.fda.gov/medwatch.||
8034|108|S|   In Canada - Call your doctor for medical advice about side||
8034|109|S|effects. You may report side effects to Health Canada at||
8034|110|S|1-866-234-2345.||
8034|111|B|||
8034|112|P|PRECAUTIONS:  See also Warning section.||
8034|113|P|   Before taking this medication, tell your doctor or pharmacist||
8034|114|P|if you are allergic to it; or if you have any other allergies.||
8034|115|P|This product may contain inactive ingredients, which can cause||
8034|116|P|allergic reactions or other problems. Talk to your pharmacist for||
8034|117|P|more details.||
8034|118|P|   Before using this medication, tell your doctor or pharmacist||
8034|119|P|your medical history, especially of: blood problems (such as low||
8034|120|P|red/white/platelet blood cell counts), a certain eye condition||
8034|121|P|(glaucoma), heart problems (such as fast/irregular heartbeat, low||
8034|122|P|blood pressure), liver disease, a brain disorder/tumor/injury,||
8034|123|P|drug/alcohol/substance abuse, breast cancer, Parkinson's disease,||
8034|124|P|seizures, a certain severe reaction to other antipsychotic-type||
8034|125|P|medications (neuroleptic malignant syndrome-NMS), difficulty||
8034|126|P|urinating (such as due to prostate problems).||
8034|127|P|   This drug may make you dizzy or drowsy or blur your vision.||
8034|128|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8034|129|P|drowsy. Do not drive, use machinery, or do anything that needs||
8034|130|P|alertness or clear vision until you can do it safely. Avoid||
8034|131|P|alcoholic beverages. Talk to your doctor if you are using||
8034|132|P|marijuana (cannabis).||
8034|133|P|   This medication may make you more sensitive to the sun. Limit||
8034|134|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8034|135|P|sunscreen and wear protective clothing when outdoors. Tell your||
8034|136|P|doctor right away if you get sunburned or have skin||
8034|137|P|blisters/redness.||
8034|138|P|   Before having surgery or imaging procedures (such as certain||
8034|139|P|X-rays, CT scans) requiring the use of contrast dye (such as||
8034|140|P|metrizamide), tell your doctor or dentist that you are using this||
8034|141|P|medication and about all the products you use (including||
8034|142|P|prescription drugs, nonprescription drugs, and herbal products).||
8034|143|P|   This medication may make you sweat less, making you more||
8034|144|P|likely to get heat stroke. Avoid doing things that may cause you||
8034|145|P|to overheat, such as hard work or exercise in hot weather, or||
8034|146|P|using hot tubs. When the weather is hot, drink a lot of fluids||
8034|147|P|and dress lightly. If you overheat, quickly look for a place to||
8034|148|P|cool down and rest. Get medical help right away if you have a||
8034|149|P|fever that does not go away, mental/mood changes, headache, or||
8034|150|P|dizziness.||
8034|151|P|   Older adults may be more sensitive to the side effects of this||
8034|152|P|drug, especially drowsiness, dizziness, lightheadedness, muscle||
8034|153|P|spasm/stiffness, and uncontrolled movements (tardive dyskinesia).||
8034|154|P|Drowsiness, dizziness, and lightheadedness can increase the risk||
8034|155|P|of falling.||
8034|156|P|   During pregnancy, this medication should be used only when||
8034|157|P|clearly needed. Babies born to mothers who have used this drug||
8034|158|P|during the last 3 months of pregnancy may rarely develop symptoms||
8034|159|P|including muscle stiffness or shakiness, drowsiness,||
8034|160|P|feeding/breathing difficulties, or constant crying. If you notice||
8034|161|P|any of these symptoms in your newborn especially during their||
8034|162|P|first month, tell the doctor right away.||
8034|163|P|   Since untreated mental/mood problems (such as schizophrenia)||
8034|164|P|can be a serious condition, do not stop taking this medication||
8034|165|P|unless directed by your doctor. If you are planning pregnancy,||
8034|166|P|become pregnant, or think you may be pregnant, immediately||
8034|167|P|discuss with your doctor the benefits and risks of using this||
8034|168|P|medication during pregnancy.||
8034|169|P|   It is unknown if this drug passes into breast milk. Consult||
8034|170|P|your doctor before breastfeeding.||
8034|171|B|||
8034|172|I|DRUG INTERACTIONS:  See also How To Use section.||
8034|173|I|   Drug interactions may change how your medications work or||
8034|174|I|increase your risk for serious side effects. This document does||
8034|175|I|not contain all possible drug interactions. Keep a list of all||
8034|176|I|the products you use (including prescription/nonprescription||
8034|177|I|drugs and herbal products) and share it with your doctor and||
8034|178|I|pharmacist. Do not start, stop, or change the dosage of any||
8034|179|I|medicines without your doctor's approval.||
8034|180|I|   A product that may interact with this drug is: metoclopramide.||
8034|181|I|   Tell your doctor or pharmacist if you are taking other||
8034|182|I|products that cause drowsiness such as opioid pain or cough||
8034|183|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8034|184|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
8034|185|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
8034|186|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8034|187|I|diphenhydramine).||
8034|188|I|   Check the labels on all your medicines (such as allergy or||
8034|189|I|cough-and-cold products) because they may contain ingredients||
8034|190|I|that cause drowsiness. Ask your pharmacist about using those||
8034|191|I|products safely.||
8034|192|B|||
8034|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8034|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8034|195|O|poison control center right away. US residents can call||
8034|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8034|197|O|Symptoms of overdose may include: slow/shallow breathing,||
8034|198|O|inability to wake up (coma).||
8034|199|B|||
8034|200|N|NOTES:  Do not share this medication with others.||
8034|201|N|   Lab and/or medical tests (such as eye exams, complete blood||
8034|202|N|count) may be done while you are taking this medication. Keep all||
8034|203|N|medical and lab appointments. Consult your doctor for more||
8034|204|N|details.||
8034|205|B|||
8034|206|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8034|207|D|remember. If it is near the time of the next dose, skip the||
8034|208|D|missed dose. Take your next dose at the regular time. Do not||
8034|209|D|double the dose to catch up.||
8034|210|B|||
8034|211|R|STORAGE:  Store at room temperature away from light and moisture.||
8034|212|R|Do not store in the bathroom. Keep all medications away from||
8034|213|R|children and pets.||
8034|214|R|   Do not flush medications down the toilet or pour them into a||
8034|215|R|drain unless instructed to do so. Properly discard this product||
8034|216|R|when it is expired or no longer needed. Consult your pharmacist||
8034|217|R|or local waste disposal company.||
8034|218|B|||
8034|219|A|Information last revised May 2025.||
8034|220|A|Copyright(c) 2025 First Databank, Inc.||
8034|221|B|||
8037|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8037|002|Z|does NOT have all possible information about this product. This||
8037|003|Z|information does not assure that this product is safe, effective,||
8037|004|Z|or appropriate for you. This information is not individual||
8037|005|Z|medical advice and does not substitute for the advice of your||
8037|006|Z|health care professional. Always ask your health care||
8037|007|Z|professional for complete information about this product and your||
8037|008|Z|specific health needs.||
8037|009|B|||
8037|010|T|INSULIN LISPRO PROTAMINE (NPL)/INSULIN LISPRO - INJECTION||
8037|011|F|(IN-sue-lin LISS-pro PRO-tah-meen(NPL)/IN-sue-lin LISS-pro)||
8037|012|B|||
8037|013|C|COMMON BRAND NAME(S): Humalog Mix||
8037|014|B|||
8037|015|U|USES:  Insulin lispro protamine/insulin lispro is used along with||
8037|016|U|a proper diet and exercise program to control high blood sugar in||
8037|017|U|people with diabetes. This product is a combination of two||
8037|018|U|man-made insulins: intermediate-acting insulin lispro protamine||
8037|019|U|and rapid-acting insulin lispro. This combination starts working||
8037|020|U|faster and lasts for a longer time than regular insulin.||
8037|021|U|   Insulin is a natural substance that allows the body to||
8037|022|U|properly use sugar from the diet. It replaces the insulin that||
8037|023|U|your body no longer produces, thereby lowering your blood sugar.||
8037|024|U|Controlling high blood sugar helps prevent kidney damage,||
8037|025|U|blindness, nerve problems, loss of limbs, and sexual function||
8037|026|U|problems. Proper control of diabetes may also lessen your risk of||
8037|027|U|a heart attack or stroke.||
8037|028|B|||
8037|029|H|HOW TO USE:  Read the Patient Information Leaflet and||
8037|030|H|Instructions for Use if available from your pharmacist before you||
8037|031|H|start using this medication and each time you get a refill. Ask||
8037|032|H|your health care professional how to prepare and use this||
8037|033|H|medication. If you have any questions, ask your doctor or||
8037|034|H|pharmacist.||
8037|035|H|   Inject this medication under the skin as directed by your||
8037|036|H|doctor, usually twice daily (15 minutes or less before the||
8037|037|H|morning and evening meal). Because this product contains a||
8037|038|H|short-acting insulin, not eating right after a dose of this||
8037|039|H|insulin may lead to low blood sugar (hypoglycemia). The injection||
8037|040|H|is given in the stomach area, the thigh, or the back of the upper||
8037|041|H|arm. Do not inject into a vein or muscle because very low blood||
8037|042|H|sugar may occur.||
8037|043|H|   The dosage is based on your medical condition and response to||
8037|044|H|treatment. Measure each dose very carefully because even small||
8037|045|H|changes in the amount of insulin may have a large effect on your||
8037|046|H|blood sugar.||
8037|047|H|   Before using, gently roll and turn the product between your||
8037|048|H|palms at least 10 times. Then, turn it upside down and right side||
8037|049|H|up 10 times to mix the medication. Do not shake the container.||
8037|050|H|Check this product for particles or discoloration. If either is||
8037|051|H|present, do not use the insulin. This product should look evenly||
8037|052|H|cloudy/milky after mixing. Do not use if you see clumps of white||
8037|053|H|material, a "frosty" appearance, or particles stuck to the sides||
8037|054|H|of the product.||
8037|055|H|   Before injecting each dose, clean the skin you are going to||
8037|056|H|inject into (the injection site) with rubbing alcohol. Change the||
8037|057|H|injection site each time to lessen injury under the skin (for||
8037|058|H|example, pits/lumps or thickened skin). Do not inject into skin||
8037|059|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
8037|060|H|not rub the injection site after a shot. Do not inject cold||
8037|061|H|insulin because this can be painful. The insulin container you||
8037|062|H|are currently using can be kept at room temperature. Learn how to||
8037|063|H|store and discard medical supplies safely.||
8037|064|H|   Do not mix this product with other insulins or use it in an||
8037|065|H|insulin pump.||
8037|066|H|   Do not change brands or types of insulin without directions on||
8037|067|H|how to do so from your doctor.||
8037|068|H|   Do not share your pen device with another person, even if the||
8037|069|H|needle is changed. You may give other people a serious infection,||
8037|070|H|or get a serious infection from them.||
8037|071|H|   Use this medication regularly to get the most benefit from it.||
8037|072|H|To help you remember, use it at the same times each day.||
8037|073|H|   Tell your doctor if your condition does not get better or if||
8037|074|H|it gets worse (your blood sugar is too high or too low).||
8037|075|B|||
8037|076|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
8037|077|S|irritation) or weight gain may occur. If any of these effects||
8037|078|S|last or get worse, tell your doctor or pharmacist promptly.||
8037|079|S|   Remember that this medication has been prescribed because your||
8037|080|S|doctor has judged that the benefit to you is greater than the||
8037|081|S|risk of side effects. Many people using this medication do not||
8037|082|S|have serious side effects.||
8037|083|S|   Tell your doctor right away if you have any serious side||
8037|084|S|effects, including: signs of low potassium level in the blood||
8037|085|S|(such as muscle cramps, weakness, irregular heartbeat).||
8037|086|S|   This medication can cause low blood sugar (hypoglycemia). This||
8037|087|S|may occur if you do not get enough calories from food or if you||
8037|088|S|do unusually heavy exercise. Symptoms of low blood sugar include||
8037|089|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
8037|090|S|dizziness, or tingling hands/feet. It is a good habit to carry||
8037|091|S|glucose tablets or gel to treat low blood sugar. If you don't||
8037|092|S|have these reliable forms of glucose, rapidly raise your blood||
8037|093|S|sugar by eating a quick source of sugar such as table sugar,||
8037|094|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
8037|095|S|doctor right away about the reaction and the use of this product.||
8037|096|S|To help prevent low blood sugar, eat meals on a regular schedule,||
8037|097|S|and do not skip meals. Check with your doctor or pharmacist to||
8037|098|S|find out what you should do if you miss a meal.||
8037|099|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
8037|100|S|thirst/urination. If these symptoms occur, tell your doctor right||
8037|101|S|away. Your doctor may need to adjust your diabetes medication,||
8037|102|S|exercise program, or diet.||
8037|103|S|   A very serious allergic reaction to this drug is rare.||
8037|104|S|However, get medical help right away if you notice any symptoms||
8037|105|S|of a serious allergic reaction, including: rash, itching/swelling||
8037|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8037|107|S|breathing.||
8037|108|S|   This is not a complete list of possible side effects. If you||
8037|109|S|notice other effects not listed above, contact your doctor or||
8037|110|S|pharmacist.||
8037|111|S|   In the US -||
8037|112|S|   Call your doctor for medical advice about side effects. You||
8037|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8037|114|S|www.fda.gov/medwatch.||
8037|115|S|   In Canada - Call your doctor for medical advice about side||
8037|116|S|effects. You may report side effects to Health Canada at||
8037|117|S|1-866-234-2345.||
8037|118|B|||
8037|119|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
8037|120|P|pharmacist if you are allergic to it; or to other insulins; or if||
8037|121|P|you have any other allergies. This product may contain inactive||
8037|122|P|ingredients, which can cause allergic reactions or other||
8037|123|P|problems. Talk to your pharmacist for more details.||
8037|124|P|   Before using this medication, tell your doctor or pharmacist||
8037|125|P|your medical history, especially of: kidney disease, liver||
8037|126|P|disease.||
8037|127|P|   Do not use this medication when you have low blood sugar.||
8037|128|P|   You may experience blurred vision, dizziness, or drowsiness||
8037|129|P|due to extremely low or high blood sugar. Do not drive, use||
8037|130|P|machinery, or do anything that needs alertness or clear vision||
8037|131|P|until you can do it safely.||
8037|132|P|   Limit alcohol while taking this medication because it can||
8037|133|P|increase the risk of developing low blood sugar.||
8037|134|P|   It may be harder to control your blood sugar when your body is||
8037|135|P|stressed (such as due to fever, infection, injury, or surgery).||
8037|136|P|Consult your doctor because this may require a change in your||
8037|137|P|treatment plan, medications, or blood sugar testing.||
8037|138|P|   Before having surgery, tell your doctor or dentist about all||
8037|139|P|the products you use (including prescription drugs,||
8037|140|P|nonprescription drugs, and herbal products).||
8037|141|P|   Check your blood sugar before and after exercise. You may need||
8037|142|P|a snack before exercising.||
8037|143|P|   If traveling across more than two time zones, ask your doctor||
8037|144|P|about how to adjust your insulin schedule.||
8037|145|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
8037|146|P|cause or worsen diabetes. Discuss a plan with your doctor for||
8037|147|P|managing your blood sugar while pregnant. Your doctor may change||
8037|148|P|your diabetes treatment during your pregnancy (such as diet and||
8037|149|P|medications including insulin).||
8037|150|P|   This medication passes into breast milk, but is unlikely to||
8037|151|P|harm a nursing infant. Consult your doctor before breastfeeding.||
8037|152|P|Your insulin needs may change while breastfeeding.||
8037|153|B|||
8037|154|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8037|155|I|medications work or increase your risk for serious side effects.||
8037|156|I|This document does not contain all possible drug interactions.||
8037|157|I|Keep a list of all the products you use (including||
8037|158|I|prescription/nonprescription drugs and herbal products) and share||
8037|159|I|it with your doctor and pharmacist. Do not start, stop, or change||
8037|160|I|the dosage of any medicines without your doctor's approval.||
8037|161|I|   Beta-blocker medications (such as metoprolol, propranolol,||
8037|162|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
8037|163|I|heartbeat you would usually feel when your blood sugar falls too||
8037|164|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
8037|165|I|dizziness, hunger, or sweating are unaffected by these drugs.||
8037|166|I|   Many drugs can affect your blood sugar, making it harder to||
8037|167|I|control. Before you start, stop, or change any medication, talk||
8037|168|I|with your doctor or pharmacist about how the medication may||
8037|169|I|affect your blood sugar. Check your blood sugar regularly as||
8037|170|I|directed and share the results with your doctor. Tell your doctor||
8037|171|I|right away if you have symptoms of high or low blood sugar. (See||
8037|172|I|also Side Effects section.) Your doctor may need to adjust your||
8037|173|I|diabetes medication, exercise program, or diet.||
8037|174|B|||
8037|175|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8037|176|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8037|177|O|poison control center right away. US residents can call||
8037|178|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8037|179|O|Symptoms of overdose may include: very fast heartbeat, vision||
8037|180|O|changes, unexplained heavy sweating, agitation, fainting,||
8037|181|O|seizures.||
8037|182|B|||
8037|183|N|NOTES:  Do not share this medication, needles, or syringes with||
8037|184|N|others.||
8037|185|N|   Attend a diabetes education program to learn more about how to||
8037|186|N|manage your diabetes with medications, diet, exercise, and||
8037|187|N|regular medical exams.||
8037|188|N|   Learn the symptoms of high and low blood sugar and how to||
8037|189|N|treat low blood sugar. Check your blood sugar regularly as||
8037|190|N|directed and share the results with your doctor.||
8037|191|N|   Lab and/or medical tests (such as liver/kidney function,||
8037|192|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
8037|193|N|should be done while you are taking this medication. Keep all||
8037|194|N|medical and lab appointments.||
8037|195|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
8037|196|B|||
8037|197|D|MISSED DOSE:  It is very important to follow your insulin regimen||
8037|198|D|exactly. Ask your doctor ahead of time what you should do if you||
8037|199|D|miss a dose of insulin.||
8037|200|B|||
8037|201|R|STORAGE:  Store all unopened insulin containers in the||
8037|202|R|refrigerator. Do not freeze, and do not use insulin that has been||
8037|203|R|frozen. If you are using the vials, store open vials in the||
8037|204|R|refrigerator or at room temperature away from direct heat and||
8037|205|R|light. Store in the carton to protect from light. Do not||
8037|206|R|refrigerate cartridges or pens that are currently in use. Discard||
8037|207|R|cartridges and vials in use after 28 days, and pens in use after||
8037|208|R|10 days, even if there is insulin left. Do not store in the||
8037|209|R|bathroom. Keep all medications away from children and pets.||
8037|210|R|   Do not flush medications down the toilet or pour them into a||
8037|211|R|drain unless instructed to do so. Properly discard this product||
8037|212|R|when it is expired or no longer needed. Consult your pharmacist||
8037|213|R|or local waste disposal company.||
8037|214|B|||
8037|215|M|MEDICAL ALERT:  Your condition can cause complications in a||
8037|216|M|medical emergency. For information about enrolling in MedicAlert,||
8037|217|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8037|218|B|||
8037|219|A|Information last revised May 2025.||
8037|220|A|Copyright(c) 2025 First Databank, Inc.||
8037|221|B|||
8039|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8039|002|Z|does NOT have all possible information about this product. This||
8039|003|Z|information does not assure that this product is safe, effective,||
8039|004|Z|or appropriate for you. This information is not individual||
8039|005|Z|medical advice and does not substitute for the advice of your||
8039|006|Z|health care professional. Always ask your health care||
8039|007|Z|professional for complete information about this product and your||
8039|008|Z|specific health needs.||
8039|009|B|||
8039|010|T|ACITRETIN - ORAL||
8039|011|F|(A-si-TRE-tin)||
8039|012|B|||
8039|013|C|COMMON BRAND NAME(S): Soriatane||
8039|014|B|||
8039|015|W|WARNING:  Do not use this medication if you are pregnant or||
8039|016|W|planning to become pregnant within 3 years of stopping this drug||
8039|017|W|because it has caused serious birth defects.||
8039|018|W|   Use 2 effective birth control methods starting 1 month before||
8039|019|W|taking this medication and at least 3 years after treatment has||
8039|020|W|stopped. Do not use "minipills" (non-estrogen-containing pills)||
8039|021|W|for birth control because they may not work as well with this||
8039|022|W|drug. Consult your doctor for more details.||
8039|023|W|   Females who are able to have children must not use this||
8039|024|W|medication unless the following requirements are met: test||
8039|025|W|negative on 2 pregnancy tests (they should be taken 1 week before||
8039|026|W|starting this drug or at least 11 days after the last act of||
8039|027|W|unprotected sexual intercourse); start therapy within 7 days of||
8039|028|W|taking the second pregnancy test; present severe psoriasis and||
8039|029|W|other treatments cannot be used; receive oral and written||
8039|030|W|information on using 2 methods of birth control while taking this||
8039|031|W|drug and for 3 years after stopping it; aware of the dangers of||
8039|032|W|birth control failure and use during pregnancy; understand and||
8039|033|W|correctly follow all birth control requirements and instructions||
8039|034|W|including monthly pregnancy tests during treatment and every 3||
8039|035|W|months for 3 years after treatment has stopped.||
8039|036|W|   Do not drink alcohol while using acitretin and for 2 months||
8039|037|W|after stopping it because alcohol causes this drug to stay in the||
8039|038|W|body longer.||
8039|039|W|   It is not known if traces of this drug found in semen of male||
8039|040|W|patients pose a risk to the unborn baby during use or after||
8039|041|W|treatment has stopped.||
8039|042|W|   Acitretin may rarely cause serious (possibly fatal) liver||
8039|043|W|disease (hepatitis) and increased fluid pressure on the brain||
8039|044|W|(pseudotumor cerebri). If you notice any of the following||
8039|045|W|unlikely but serious side effects, get medical help right away:||
8039|046|W|headache that is severe or doesn't go away, nausea/vomiting that||
8039|047|W|doesn't stop, loss of appetite, yellowing eyes/skin, dark urine,||
8039|048|W|severe stomach/abdominal pain, unusual tiredness, or vision||
8039|049|W|changes (such as blurred/double vision, decreased vision).||
8039|050|W|   Acitretin has also been linked to pancreatitis (inflammation||
8039|051|W|of the pancreas). Tell your doctor right away if you develop||
8039|052|W|lower abdominal pain that doesn't go away.||
8039|053|W|   Rarely, acitretin may cause serious mental/mood changes, even||
8039|054|W|after stopping the medication. Get medical help right away if you||
8039|055|W|have symptoms such as depression, irritability, aggressive or||
8039|056|W|violent behavior, or thoughts of suicide.||
8039|057|B|||
8039|058|U|USES:  This medication is a retinoid used in the treatment of||
8039|059|U|severe psoriasis and other skin disorders in adults.||
8039|060|B|||
8039|061|H|HOW TO USE:  Read the Medication Guide provided by your||
8039|062|H|pharmacist before you start using acitretin and each time you get||
8039|063|H|a refill. Also, read and complete the Patient Agreement and||
8039|064|H|Informed Consent document before taking this drug. If you have||
8039|065|H|any questions, ask your doctor or pharmacist.||
8039|066|H|   Take this medication by mouth as directed by your doctor,||
8039|067|H|usually once a day with your main meal.||
8039|068|H|   The dosage is based on your medical condition and response to||
8039|069|H|treatment. Do not take this more often or increase your dose||
8039|070|H|without consulting your doctor. Your condition will not improve||
8039|071|H|any faster but the risk of side effects may increase.||
8039|072|H|   It may take 2 to 3 months before the full benefit of this||
8039|073|H|medication is seen.||
8039|074|H|   Use this medication regularly in order to get the most benefit||
8039|075|H|from it. Remember to use it at the same time each day.||
8039|076|H|   Since this drug can be absorbed through the skin and lungs and||
8039|077|H|may harm an unborn baby, women who are pregnant or who may become||
8039|078|H|pregnant should not handle this medication or breathe the dust||
8039|079|H|from the capsules.||
8039|080|B|||
8039|081|S|SIDE EFFECTS:  See also Warning section.||
8039|082|S|   You may experience more redness, itching, skin scaling,||
8039|083|S|peeling and dry skin during the first few weeks as your body||
8039|084|S|adjusts to the medication. Dry eyes, eye irritation, crusting of||
8039|085|S|the eye lids, dry mouth, skin peeling on the||
8039|086|S|fingertips/palms/soles of feet, chapped lips, runny nose, thirst,||
8039|087|S|taste changes and hair loss may also occur. If any of these||
8039|088|S|effects last or get worse, tell your doctor or pharmacist||
8039|089|S|promptly.||
8039|090|S|   Contact lens wearers may be uncomfortable while taking this||
8039|091|S|drug because it causes dry eyes.||
8039|092|S|   Remember that this medication has been prescribed because your||
8039|093|S|doctor has judged that the benefit to you is greater than the||
8039|094|S|risk of side effects. Many people using this medication do not||
8039|095|S|have serious side effects.||
8039|096|S|   Tell your doctor right away if you have any serious side||
8039|097|S|effects, including: decreased night vision, fever, chills,||
8039|098|S|dizziness, bone/joint pain, muscle pain/tenderness/weakness,||
8039|099|S|difficulty moving, swelling, sudden weight gain, signs of kidney||
8039|100|S|problems (such as change in the amount of urine).||
8039|101|S|   A very serious allergic reaction to this drug is rare.||
8039|102|S|However, get medical help right away if you notice any symptoms||
8039|103|S|of a serious allergic reaction, including: rash, itching/swelling||
8039|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8039|105|S|breathing.||
8039|106|S|   This is not a complete list of possible side effects. If you||
8039|107|S|notice other effects not listed above, contact your doctor or||
8039|108|S|pharmacist.||
8039|109|S|   In the US -||
8039|110|S|   Call your doctor for medical advice about side effects. You||
8039|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8039|112|S|www.fda.gov/medwatch.||
8039|113|S|   In Canada - Call your doctor for medical advice about side||
8039|114|S|effects. You may report side effects to Health Canada at||
8039|115|S|1-866-234-2345.||
8039|116|B|||
8039|117|P|PRECAUTIONS:  See also Warning section.||
8039|118|P|   Before taking acitretin, tell your doctor or pharmacist if you||
8039|119|P|are allergic to it; or to vitamin A-related drugs (other||
8039|120|P|retinoids such as isotretinoin); or if you have any other||
8039|121|P|allergies. This product may contain inactive ingredients, which||
8039|122|P|can cause allergic reactions or other problems. Talk to your||
8039|123|P|pharmacist for more details.||
8039|124|P|   Before using this medication, tell your doctor or pharmacist||
8039|125|P|your medical history, especially of: kidney disease, liver||
8039|126|P|disease, heart disease, diabetes, personal/family history of||
8039|127|P|mental/mood problems (such as depression).||
8039|128|P|   Do not donate blood while taking this drug and for at least 3||
8039|129|P|years after stopping therapy. This will prevent the possibility||
8039|130|P|of your blood being given to a pregnant woman.||
8039|131|P|   This medication may make you more sensitive to the sun. Limit||
8039|132|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8039|133|P|sunscreen and wear protective clothing when outdoors. Tell your||
8039|134|P|doctor right away if you get sunburned or have skin||
8039|135|P|blisters/redness. Your doctor may direct you to limit or avoid||
8039|136|P|phototherapy while you use this product. Ask your doctor for||
8039|137|P|details.||
8039|138|P|   Acitretin may cause vision changes, including decreased night||
8039|139|P|vision. Do not drive, use machinery, or do anything that needs||
8039|140|P|clear vision (especially at night) until you can do it safely.||
8039|141|P|   Avoid drinking alcohol while taking this medication and for 2||
8039|142|P|months after stopping it.||
8039|143|P|   This drug must not be used during pregnancy. It may harm an||
8039|144|P|unborn baby. If you become pregnant or think you may be pregnant,||
8039|145|P|tell your doctor right away. This drug should not be used if you||
8039|146|P|are planning to become pregnant during treatment or within 3||
8039|147|P|years after use has stopped.||
8039|148|P|   Since this drug can be absorbed through the skin and lungs and||
8039|149|P|may harm an unborn baby, women who are pregnant or who may become||
8039|150|P|pregnant should not handle this medication or breathe the dust||
8039|151|P|from the capsules.||
8039|152|P|   Semen may pose a risk to a pregnant woman if a male is using||
8039|153|P|this drug. Consult your doctor.||
8039|154|P|   This medication passes into breast milk. Because of the||
8039|155|P|possible risk to the infant, breastfeeding is not recommended||
8039|156|P|while using this medication and for at least three years after||
8039|157|P|the last dose. Consult your doctor before breastfeeding.||
8039|158|B|||
8039|159|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8039|160|I|medications work or increase your risk for serious side effects.||
8039|161|I|This document does not contain all possible drug interactions.||
8039|162|I|Keep a list of all the products you use (including||
8039|163|I|prescription/nonprescription drugs and herbal products) and share||
8039|164|I|it with your doctor and pharmacist. Do not start, stop, or change||
8039|165|I|the dosage of any medicines without your doctor's approval.||
8039|166|I|   Some products that may interact with this drug include:||
8039|167|I|methotrexate, St. John's wort, tetracycline antibiotics, vitamin||
8039|168|I|A.||
8039|169|B|||
8039|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8039|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8039|172|O|poison control center right away. US residents can call||
8039|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8039|174|O|Symptoms of overdose may include severe headache, nausea,||
8039|175|O|vomiting, drowsiness, irritability, loss of balance, and itching.||
8039|176|B|||
8039|177|N|NOTES:  Do not share this medication with others.||
8039|178|N|   Lab and/or medical tests (such as liver function, X-rays,||
8039|179|N|cholesterol tests, pregnancy tests) should be done before you||
8039|180|N|start taking this medication and while you are taking it. Keep||
8039|181|N|all medical and lab appointments. Consult your doctor for more||
8039|182|N|details.||
8039|183|B|||
8039|184|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8039|185|D|remember. If it is near the time of your next dose, skip the||
8039|186|D|missed dose. Take your next dose at the regular time. Do not||
8039|187|D|double the dose to catch up.||
8039|188|B|||
8039|189|R|STORAGE:  Store at room temperature away from light and moisture.||
8039|190|R|Do not store in the bathroom. Keep all medications away from||
8039|191|R|children and pets.||
8039|192|R|   Do not flush medications down the toilet or pour them into a||
8039|193|R|drain unless instructed to do so. Properly discard this product||
8039|194|R|when it is expired or no longer needed. Consult your pharmacist||
8039|195|R|or local waste disposal company.||
8039|196|B|||
8039|197|A|Information last revised April 2025.||
8039|198|A|Copyright(c) 2025 First Databank, Inc.||
8039|199|B|||
8041|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8041|002|Z|does NOT have all possible information about this product. This||
8041|003|Z|information does not assure that this product is safe, effective,||
8041|004|Z|or appropriate for you. This information is not individual||
8041|005|Z|medical advice and does not substitute for the advice of your||
8041|006|Z|health care professional. Always ask your health care||
8041|007|Z|professional for complete information about this product and your||
8041|008|Z|specific health needs.||
8041|009|B|||
8041|010|T|SELEGILINE - ORAL||
8041|011|F|(seh-LEDGE-uh-leen)||
8041|012|B|||
8041|013|C|COMMON BRAND NAME(S): Eldepryl||
8041|014|B|||
8041|015|U|USES:  This medication is used to treat movement disorders caused||
8041|016|U|by Parkinson's disease. It does not cure Parkinson's disease, but||
8041|017|U|it may improve shakiness (tremor), muscle stiffness, loss of||
8041|018|U|normal movement as your dose of other Parkinson's medication||
8041|019|U|wears off (end-of-dose failure), and sudden switching between||
8041|020|U|normal movement and stiffness ("on-off" problems). It may improve||
8041|021|U|your range of motion and ability to walk, dress, and exercise.||
8041|022|U|Selegiline is usually used in combination with other medicines||
8041|023|U|(such as levodopa, carbidopa).||
8041|024|U|   Selegiline is an enzyme blocker (MAO inhibitor) that works by||
8041|025|U|slowing the breakdown of certain natural substances in the brain||
8041|026|U|(neurotransmitters such as dopamine, norepinephrine, and||
8041|027|U|serotonin).||
8041|028|B|||
8041|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
8041|030|H|doctor, usually twice daily with breakfast and lunch. Taking||
8041|031|H|selegiline late in the day may cause trouble sleeping. The dosage||
8041|032|H|is based on your medical condition and response to treatment. Do||
8041|033|H|not increase your dose or take it more often than directed.||
8041|034|H|   After you have been taking selegiline for 2 or 3 days, your||
8041|035|H|doctor may direct you to lower your levodopa dose. Follow your||
8041|036|H|doctor's instructions closely. Do not stop or change the dose of||
8041|037|H|any of your medications without first talking with your doctor.||
8041|038|H|   To prevent a very serious high blood pressure reaction, it is||
8041|039|H|very important that you follow a special diet recommended by your||
8041|040|H|doctor or dietician to limit your intake of tyramine while you||
8041|041|H|are taking this medicine. Avoid foods and beverages that are high||
8041|042|H|in tyramine, including aged cheeses, dried/aged meats and||
8041|043|H|sausages (such as salami, liverwurst), preserved fish (such as||
8041|044|H|pickled herring), products that contain large amounts of yeast||
8041|045|H|(such as bouillon cubes, powdered soup/gravy, homemade or||
8041|046|H|sourdough bread), fermented foods (such as sauerkraut, kim chee),||
8041|047|H|most soybean products (such as soy sauce, tofu), broad/fava||
8041|048|H|beans, red wine, sherry, tap beers, and vermouth. Consult your||
8041|049|H|doctor or dietician for more details and a complete list of other||
8041|050|H|foods that contain tyramine which you should limit or avoid.||
8041|051|H|   It may take a few weeks for the full benefits of the drug to||
8041|052|H|be noticed. Do not stop taking this drug without first consulting||
8041|053|H|your doctor. Tell your doctor if the medication stops working||
8041|054|H|well or if your condition gets worse.||
8041|055|B|||
8041|056|S|SIDE EFFECTS:  Dizziness, abdominal pain, dry mouth, nausea,||
8041|057|S|stomach upset, trouble sleeping, and headache may occur. If any||
8041|058|S|of these effects last or get worse, tell your doctor or||
8041|059|S|pharmacist promptly.||
8041|060|S|   To reduce the risk of dizziness and lightheadedness, get up||
8041|061|S|slowly when rising from a sitting or lying position.||
8041|062|S|   If you are also taking levodopa, you may experience more side||
8041|063|S|effects from the levodopa when taking selegiline. Tell your||
8041|064|S|doctor right away if any of these side effects occur: nausea,||
8041|065|S|shakiness, muscle stiffness, mental/mood changes such as||
8041|066|S|hallucinations/abnormal dreams. Your doctor may need to change||
8041|067|S|your medication or dose. Do not stop or change the dose of your||
8041|068|S|levodopa without talking with your doctor first.||
8041|069|S|   Remember that this medication has been prescribed because your||
8041|070|S|doctor has judged that the benefit to you is greater than the||
8041|071|S|risk of side effects. Many people using this medication do not||
8041|072|S|have serious side effects.||
8041|073|S|   Some people taking selegiline have fallen asleep suddenly||
8041|074|S|during their usual daily activities (such as talking on the||
8041|075|S|phone, driving). In some cases, sleep occurred without any||
8041|076|S|feelings of drowsiness beforehand. This sleep effect may occur||
8041|077|S|anytime during treatment with selegiline even if you have used||
8041|078|S|this medication for a long time. If you experience increased||
8041|079|S|sleepiness or fall asleep during the day, do not drive or take||
8041|080|S|part in other possibly dangerous activities until you have||
8041|081|S|discussed this effect with your doctor. Your risk of this sleep||
8041|082|S|effect is increased by using alcohol or other medications that||
8041|083|S|can make you drowsy. See also Precautions section.||
8041|084|S|   Tell your doctor right away if you have any serious side||
8041|085|S|effects, including: fainting, loss of balance, mental/mood||
8041|086|S|changes (such as agitation, confusion, depression,||
8041|087|S|hallucinations), unusual strong urges (such as increased||
8041|088|S|gambling, increased sexual urges), worsening muscle||
8041|089|S|stiffness/twitching, changes in sexual ability/interest,||
8041|090|S|increased shaking (tremor), swollen ankles/legs, difficulty||
8041|091|S|urinating, unusual weight gain, easy bleeding/bruising,||
8041|092|S|black/tarry stools, vomit that looks like coffee grounds.||
8041|093|S|   This drug may rarely cause an attack of extremely high blood||
8041|094|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
8041|095|S|food interactions can increase this risk (See also How to Use and||
8041|096|S|Drug Interactions sections). Get medical help right away if any||
8041|097|S|of these serious side effects occur: frequent/severe headache,||
8041|098|S|fast/slow/irregular/pounding heartbeat, chest pain, neck||
8041|099|S|stiffness/soreness, severe nausea/vomiting, sweating/clammy skin||
8041|100|S|(sometimes with fever), widened pupils, vision changes (such as||
8041|101|S|double/blurred vision), sudden sensitivity to light||
8041|102|S|(photophobia).||
8041|103|S|   This medication may increase serotonin and rarely cause a very||
8041|104|S|serious condition called serotonin syndrome. The risk increases||
8041|105|S|if you are also taking other drugs that increase serotonin, so||
8041|106|S|tell your doctor or pharmacist of all the drugs you take. Get||
8041|107|S|medical help right away if you develop some of the following||
8041|108|S|symptoms: hallucinations, unusual restlessness, loss of||
8041|109|S|coordination, fast heartbeat, severe dizziness, unexplained||
8041|110|S|fever, severe nausea/vomiting/diarrhea, twitching muscle.||
8041|111|S|   A very serious allergic reaction to this drug is rare.||
8041|112|S|However, get medical help right away if you notice any symptoms||
8041|113|S|of a serious allergic reaction, including: rash, itching/swelling||
8041|114|S|(especially of the face/tongue/throat), dizziness, trouble||
8041|115|S|breathing.||
8041|116|S|   This is not a complete list of possible side effects. If you||
8041|117|S|notice other effects not listed above, contact your doctor or||
8041|118|S|pharmacist.||
8041|119|S|   In the US -||
8041|120|S|   Call your doctor for medical advice about side effects. You||
8041|121|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8041|122|S|www.fda.gov/medwatch.||
8041|123|S|   In Canada - Call your doctor for medical advice about side||
8041|124|S|effects. You may report side effects to Health Canada at||
8041|125|S|1-866-234-2345.||
8041|126|B|||
8041|127|P|PRECAUTIONS:  Before taking selegiline, tell your doctor or||
8041|128|P|pharmacist if you are allergic to it; or if you have any other||
8041|129|P|allergies. This product may contain inactive ingredients, which||
8041|130|P|can cause allergic reactions or other problems. Talk to your||
8041|131|P|pharmacist for more details.||
8041|132|P|   Before using this medication, tell your doctor or pharmacist||
8041|133|P|your medical history, especially of: a certain adrenal gland||
8041|134|P|tumor (pheochromocytoma), cerebrovascular disease (such as||
8041|135|P|stroke), heart problems (such as heart failure, heart attack),||
8041|136|P|bleeding problems, history of severe/frequent headaches, peptic||
8041|137|P|ulcer, diabetes, personal/family history of mental/mood disorders||
8041|138|P|(such as schizophrenia, bipolar disorder), personal/family||
8041|139|P|history of high blood pressure, liver disease, overactive thyroid||
8041|140|P|(hyperthyroidism).||
8041|141|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8041|142|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8041|143|P|machinery, or do anything that needs alertness until you can do||
8041|144|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8041|145|P|are using marijuana (cannabis). See also Side Effects section.||
8041|146|P|   Before having surgery, tell your doctor or dentist about all||
8041|147|P|the products you use (including prescription drugs,||
8041|148|P|nonprescription drugs, and herbal products). You may need to stop||
8041|149|P|taking selegiline before surgery. Follow your doctor's||
8041|150|P|instructions carefully.||
8041|151|P|   During pregnancy, selegiline should be used only when clearly||
8041|152|P|needed. Discuss the risks and benefits with your doctor.||
8041|153|P|   It is unknown if this drug passes into breast milk. Because of||
8041|154|P|the possible risk to the infant, breastfeeding is not recommended||
8041|155|P|while using this drug and for 7 days after the last dose. Consult||
8041|156|P|your doctor before breastfeeding.||
8041|157|B|||
8041|158|I|DRUG INTERACTIONS:  See also How to Use section.||
8041|159|I|   Drug interactions may change how your medications work or||
8041|160|I|increase your risk for serious side effects. This document does||
8041|161|I|not contain all possible drug interactions. Keep a list of all||
8041|162|I|the products you use (including prescription/nonprescription||
8041|163|I|drugs and herbal products) and share it with your doctor and||
8041|164|I|pharmacist. Do not start, stop, or change the dosage of any||
8041|165|I|medicines without your doctor's approval.||
8041|166|I|   Some products that may interact with selegiline include:||
8041|167|I|antidepressants (including bupropion, maprotiline, mirtazapine),||
8041|168|I|other MAO inhibitors (isocarboxazid, linezolid, metaxalone,||
8041|169|I|methylene blue, moclobemide, phenelzine, procarbazine,||
8041|170|I|rasagiline, safinamide, tranylcypromine), appetite suppressants||
8041|171|I|(such as diethylpropion), drugs for attention deficit disorder||
8041|172|I|(such as atomoxetine, methylphenidate), apraclonidine, buspirone,||
8041|173|I|carbamazepine/oxcarbazepine, cyclobenzaprine, deutetrabenazine,||
8041|174|I|fentanyl, metoclopramide, street drugs (such as LSD, mescaline),||
8041|175|I|supplements (such as tryptophan, tyramine), tetrabenazine,||
8041|176|I|certain "triptans" used to treat migraine headaches (such as||
8041|177|I|rizatriptan, sumatriptan, zolmitriptan), valbenazine.||
8041|178|I|   The risk of serotonin syndrome/toxicity increases if you are||
8041|179|I|also taking other drugs that increase serotonin. Examples include||
8041|180|I|street drugs such as MDMA/"ecstasy," St. John's wort,||
8041|181|I|dextromethorphan, certain antidepressants (including SSRIs such||
8041|182|I|as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine,||
8041|183|I|TCAs such as amitriptyline/doxepin), certain opioid medications||
8041|184|I|(such as meperidine, methadone, pentazocine, propoxyphene,||
8041|185|I|tramadol, tapentadol), among others. The risk of serotonin||
8041|186|I|syndrome/toxicity may be more likely when you start or increase||
8041|187|I|the dose of these drugs.||
8041|188|I|   Tell your doctor or pharmacist if you are using any of these||
8041|189|I|medications before, during, or within 2 weeks after treatment||
8041|190|I|with selegiline. Tell your doctor or pharmacist if you have taken||
8041|191|I|fluoxetine during at least 5 weeks before starting selegiline.||
8041|192|I|Discuss with your doctor how much time to wait between starting||
8041|193|I|or stopping any of these drugs and taking selegiline.||
8041|194|I|   Before using selegiline, report the use of drugs that may||
8041|195|I|increase the risk of extremely high blood pressure (hypertensive||
8041|196|I|crisis) when combined with selegiline, including herbal products||
8041|197|I|(such as ephedra/ma huang), nasal decongestants (such as||
8041|198|I|phenylephrine, pseudoephedrine), and stimulants (such as||
8041|199|I|amphetamines, ephedrine, epinephrine, phenylalanine). Selegiline||
8041|200|I|should not be used with any of these medications. Talk to your||
8041|201|I|doctor or pharmacist for more details.||
8041|202|I|   Check the labels on all your medicines (such as allergy,||
8041|203|I|cough-and-cold products, diet pills) because they may contain||
8041|204|I|dextromethorphan, decongestants, or stimulants. Ask your||
8041|205|I|pharmacist about the safe use of those products.||
8041|206|I|   This medication may interfere with certain medical/lab tests||
8041|207|I|(such as brain scan for Parkinson's disease), possibly causing||
8041|208|I|false test results. Make sure lab personnel and all your doctors||
8041|209|I|know you use this drug.||
8041|210|B|||
8041|211|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8041|212|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8041|213|O|poison control center right away. US residents can call||
8041|214|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8041|215|O|Symptoms of overdose may be not appear for up to 12 hours and may||
8041|216|O|include excitement, irritability, restlessness, weakness,||
8041|217|O|drowsiness, flushing, sweating, fast heartbeat, headache,||
8041|218|O|confusion, and seizures.||
8041|219|B|||
8041|220|N|NOTES:  Do not share this medication with others.||
8041|221|B|||
8041|222|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8041|223|D|remember. If it is near the time of the next dose, skip the||
8041|224|D|missed dose. Take your next dose at the regular time. Do not||
8041|225|D|double the dose to catch up.||
8041|226|B|||
8041|227|R|STORAGE:  Store at room temperature away from light and moisture.||
8041|228|R|Do not store in the bathroom. Keep all medications away from||
8041|229|R|children and pets.||
8041|230|R|   Do not flush medications down the toilet or pour them into a||
8041|231|R|drain unless instructed to do so. Properly discard this product||
8041|232|R|when it is expired or no longer needed. Consult your pharmacist||
8041|233|R|or local waste disposal company.||
8041|234|B|||
8041|235|A|Information last revised November 2025.||
8041|236|A|Copyright(c) 2025 First Databank, Inc.||
8041|237|B|||
8043|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8043|002|Z|does NOT have all possible information about this product. This||
8043|003|Z|information does not assure that this product is safe, effective,||
8043|004|Z|or appropriate for you. This information is not individual||
8043|005|Z|medical advice and does not substitute for the advice of your||
8043|006|Z|health care professional. Always ask your health care||
8043|007|Z|professional for complete information about this product and your||
8043|008|Z|specific health needs.||
8043|009|B|||
8043|010|T|FUROSEMIDE - ORAL||
8043|011|F|(fyou-ROW-seh-mide)||
8043|012|B|||
8043|013|C|COMMON BRAND NAME(S): Lasix||
8043|014|B|||
8043|015|W|WARNING:  Furosemide is a very potent medication. Using too much||
8043|016|W|of this drug can lead to serious water and salt/mineral loss. It||
8043|017|W|is important that you are closely monitored by your doctor while||
8043|018|W|taking this medication. Tell your doctor right away if you become||
8043|019|W|very thirsty or confused, or develop muscle cramps/weakness. See||
8043|020|W|also Side Effects section.||
8043|021|B|||
8043|022|U|USES:  Furosemide is used to reduce extra fluid in the body||
8043|023|U|(edema) caused by conditions such as heart failure, liver||
8043|024|U|disease, and kidney disease. This can lessen symptoms such as||
8043|025|U|shortness of breath and swelling in your arms, legs, and abdomen.||
8043|026|U|   This drug is also used to treat high blood pressure. Lowering||
8043|027|U|high blood pressure helps prevent strokes, heart attacks, and||
8043|028|U|kidney problems.||
8043|029|U|   Furosemide is a "water pill" (diuretic) that causes you to||
8043|030|U|make more urine. This helps your body get rid of extra water and||
8043|031|U|salt.||
8043|032|B|||
8043|033|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8043|034|H|from your pharmacist before you start taking furosemide and each||
8043|035|H|time you get a refill. If you have any questions, ask your doctor||
8043|036|H|or pharmacist.||
8043|037|H|   Take this medication by mouth with or without food as directed||
8043|038|H|by your doctor, usually once or twice daily. It is best to avoid||
8043|039|H|taking this medication within 4 hours of your bedtime to prevent||
8043|040|H|having to get up to urinate.||
8043|041|H|   The dosage is based on your medical condition, age, and||
8043|042|H|response to treatment. Children's dosage is also based on weight.||
8043|043|H|Older adults usually start with a lower dose to decrease the risk||
8043|044|H|of side effects. Do not increase your dose or take it more often||
8043|045|H|than directed.||
8043|046|H|   Take this medication regularly in order to get the most||
8043|047|H|benefit from it. To help you remember, take it at the same||
8043|048|H|time(s) of the day as directed. Keep taking this medication even||
8043|049|H|if you feel well. Most people with high blood pressure do not||
8043|050|H|feel sick.||
8043|051|H|   Sucralfate, cholestyramine, and colestipol can decrease the||
8043|052|H|absorption of furosemide. If you are taking any of these drugs,||
8043|053|H|separate the timing of each dose from furosemide by at least 2||
8043|054|H|hours.||
8043|055|H|   Tell your doctor if your condition does not get better or if||
8043|056|H|it gets worse (for example, your blood pressure readings remain||
8043|057|H|high or increase).||
8043|058|B|||
8043|059|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, or blurred||
8043|060|S|vision may occur as your body adjusts to the medication. If any||
8043|061|S|of these effects last or get worse, tell your doctor or||
8043|062|S|pharmacist promptly.||
8043|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
8043|064|S|slowly when rising from a sitting or lying position.||
8043|065|S|   Remember that this medication has been prescribed because your||
8043|066|S|doctor has judged that the benefit to you is greater than the||
8043|067|S|risk of side effects. Many people using this medication do not||
8043|068|S|have serious side effects.||
8043|069|S|   This medication may cause dehydration and electrolyte||
8043|070|S|imbalance. Tell your doctor right away if you have any symptoms||
8043|071|S|of dehydration or electrolyte imbalance, including unusual dry||
8043|072|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
8043|073|S|heartbeat, or confusion.||
8043|074|S|   Tell your doctor right away if you have any serious side||
8043|075|S|effects, including: signs of kidney problems (such as change in||
8043|076|S|the amount of urine), fainting,||
8043|077|S|numbness/tingling/pain/redness/swelling of the arms/legs, hearing||
8043|078|S|changes (such as ringing in the ears, temporary or permanent||
8043|079|S|decreased hearing/deafness), signs of liver problems (such as||
8043|080|S|stomach/abdominal pain, yellowing eyes/skin).||
8043|081|S|   A very serious allergic reaction to this drug is rare.||
8043|082|S|However, get medical help right away if you notice any symptoms||
8043|083|S|of a serious allergic reaction, including: rash, itching/swelling||
8043|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8043|085|S|breathing.||
8043|086|S|   This is not a complete list of possible side effects. If you||
8043|087|S|notice other effects not listed above, contact your doctor or||
8043|088|S|pharmacist.||
8043|089|S|   In the US -||
8043|090|S|   Call your doctor for medical advice about side effects. You||
8043|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8043|092|S|www.fda.gov/medwatch.||
8043|093|S|   In Canada - Call your doctor for medical advice about side||
8043|094|S|effects. You may report side effects to Health Canada at||
8043|095|S|1-866-234-2345.||
8043|096|B|||
8043|097|P|PRECAUTIONS:  Before taking furosemide, tell your doctor or||
8043|098|P|pharmacist if you are allergic to it; or if you have any other||
8043|099|P|allergies. This product may contain inactive ingredients, which||
8043|100|P|can cause allergic reactions or other problems. Talk to your||
8043|101|P|pharmacist for more details.||
8043|102|P|   Before using this medication, tell your doctor or pharmacist||
8043|103|P|your medical history, especially of: kidney problems, liver||
8043|104|P|problems, inability to make urine, gout, lupus.||
8043|105|P|   If you have diabetes, furosemide may make it harder to control||
8043|106|P|your blood sugar. Check your blood sugar regularly as directed||
8043|107|P|and share the results with your doctor.||
8043|108|P|   Furosemide may reduce the potassium level in your blood. Your||
8043|109|P|doctor may instruct you to add potassium-rich foods to your diet||
8043|110|P|(such as bananas, orange juice) or prescribe potassium||
8043|111|P|supplements to prevent potassium loss. Ask your doctor for more||
8043|112|P|details.||
8043|113|P|   This medication may make you more sensitive to the sun. Limit||
8043|114|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8043|115|P|sunscreen and wear protective clothing when outdoors. Tell your||
8043|116|P|doctor right away if you get sunburned or have skin||
8043|117|P|blisters/redness.||
8043|118|P|   This drug may make you dizzy or blur your vision. Alcohol or||
8043|119|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
8043|120|P|machinery, or do anything that needs alertness or clear vision||
8043|121|P|until you can do it safely. Limit alcoholic beverages. Talk to||
8043|122|P|your doctor if you are using marijuana (cannabis).||
8043|123|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
8043|124|P|and cause you to feel lightheaded. Tell your doctor if you have||
8043|125|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
8043|126|P|of fluids unless your doctor tells you not to.||
8043|127|P|   Before having surgery, tell your doctor or dentist about all||
8043|128|P|the products you use (including prescription drugs,||
8043|129|P|nonprescription drugs, and herbal products).||
8043|130|P|   Babies born early (premature infants) and children may be more||
8043|131|P|sensitive to certain effects of this drug, such as kidney stones.||
8043|132|P|   Older adults may be more sensitive to the effects of this||
8043|133|P|drug, especially dizziness and water/mineral loss.||
8043|134|P|   During pregnancy, this medication should be used only when||
8043|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
8043|136|P|   This drug passes into breast milk. Consult your doctor before||
8043|137|P|breastfeeding.||
8043|138|B|||
8043|139|I|DRUG INTERACTIONS:  See also the How to Use section.||
8043|140|I|   Drug interactions may change how your medications work or||
8043|141|I|increase your risk for serious side effects. This document does||
8043|142|I|not contain all possible drug interactions. Keep a list of all||
8043|143|I|the products you use (including prescription/nonprescription||
8043|144|I|drugs and herbal products) and share it with your doctor and||
8043|145|I|pharmacist. Do not start, stop, or change the dosage of any||
8043|146|I|medicines without your doctor's approval.||
8043|147|I|   Some products that may interact with this drug include:||
8043|148|I|desmopressin, ethacrynic acid, lithium.||
8043|149|I|   Some products have ingredients that could raise your blood||
8043|150|I|pressure or worsen your swelling. Tell your pharmacist what||
8043|151|I|products you are using, and ask how to use them safely||
8043|152|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
8043|153|I|ibuprofen/naproxen).||
8043|154|I|   This medication may interfere with certain lab tests (such as||
8043|155|I|thyroid hormone levels), possibly causing false test results.||
8043|156|I|Make sure lab personnel and all your doctors know you use this||
8043|157|I|drug.||
8043|158|B|||
8043|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8043|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8043|161|O|poison control center right away. US residents can call||
8043|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8043|163|O|Symptoms of overdose may include: fainting, severe weakness, a||
8043|164|O|severe decrease in the amount of urine.||
8043|165|B|||
8043|166|N|NOTES:  Do not share this medication with others.||
8043|167|N|   Lifestyle changes that may help this medication work better||
8043|168|N|include exercising, stopping smoking, reducing stress, and||
8043|169|N|changing your diet. Consult your doctor for more details.||
8043|170|N|   Lab and/or medical tests (such as kidney function, blood||
8043|171|N|mineral levels such as potassium) should be done while you are||
8043|172|N|taking this medication. Keep all medical and lab appointments.||
8043|173|N|Consult your doctor for more details.||
8043|174|N|   Check your blood pressure regularly while taking this||
8043|175|N|medication. Learn how to monitor your own blood pressure at home,||
8043|176|N|and share the results with your doctor.||
8043|177|B|||
8043|178|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8043|179|D|remember. If it is near the time of the next dose, skip the||
8043|180|D|missed dose. Take your next dose at the regular time. Do not||
8043|181|D|double the dose to catch up.||
8043|182|B|||
8043|183|R|STORAGE:  Store at room temperature away from light and moisture.||
8043|184|R|Do not store in the bathroom. Keep all medications away from||
8043|185|R|children and pets.||
8043|186|R|   Do not flush medications down the toilet or pour them into a||
8043|187|R|drain unless instructed to do so. Properly discard this product||
8043|188|R|when it is expired or no longer needed. Consult your pharmacist||
8043|189|R|or local waste disposal company.||
8043|190|B|||
8043|191|A|Information last revised October 2024.||
8043|192|A|Copyright(c) 2025 First Databank, Inc.||
8043|193|B|||
8046|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8046|002|Z|does NOT have all possible information about this product. This||
8046|003|Z|information does not assure that this product is safe, effective,||
8046|004|Z|or appropriate for you. This information is not individual||
8046|005|Z|medical advice and does not substitute for the advice of your||
8046|006|Z|health care professional. Always ask your health care||
8046|007|Z|professional for complete information about this product and your||
8046|008|Z|specific health needs.||
8046|009|B|||
8046|010|T|FLUOROURACIL - INJECTION||
8046|011|F|(flewr-oh-YOUR-uh-sill)||
8046|012|B|||
8046|013|C|COMMON BRAND NAME(S): Adrucil||
8046|014|B|||
8046|015|U|USES:  Fluorouracil is used to treat various types of cancer. It||
8046|016|U|is a chemotherapy drug that is used to slow or stop cancer cell||
8046|017|U|growth.||
8046|018|B|||
8046|019|H|HOW TO USE:  This medication is usually given by injection into a||
8046|020|H|vein by a health care professional. It may also be given by other||
8046|021|H|methods of injection depending upon your medical condition. The||
8046|022|H|dosage is based on your medical condition, body size, and||
8046|023|H|response to treatment.||
8046|024|B|||
8046|025|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, dry/itchy||
8046|026|S|skin, or skin darkening may occur. Nausea and vomiting can be||
8046|027|S|severe. In some cases, drug therapy may be necessary to prevent||
8046|028|S|or relieve nausea and vomiting. Not eating before your treatment||
8046|029|S|may help relieve vomiting. Changes in diet such as eating several||
8046|030|S|small meals or limiting activity may help lessen some of these||
8046|031|S|effects. If any of these effects last or get worse, tell your||
8046|032|S|doctor or pharmacist promptly.||
8046|033|S|   Mild diarrhea is also a common side effect. However, diarrhea||
8046|034|S|can rarely become severe, causing very serious problems due to||
8046|035|S|dehydration. Tell your doctor right away if you develop: diarrhea||
8046|036|S|that is severe or doesn't stop, abdominal or stomach||
8046|037|S|pain/cramping, or blood/mucus in your stool.||
8046|038|S|   Temporary hair loss may occur. Normal hair growth should||
8046|039|S|return after treatment has ended.||
8046|040|S|   Remember that this medication has been prescribed because your||
8046|041|S|doctor has judged that the benefit to you is greater than the||
8046|042|S|risk of side effects. Many people using this medication do not||
8046|043|S|have serious side effects.||
8046|044|S|   Hand and foot problems sometimes occur with fluorouracil use.||
8046|045|S|You can prevent or reduce these problems by protecting your hands||
8046|046|S|and feet from a great deal of heat or pressure. For example,||
8046|047|S|avoid taking hot baths/showers, handwashing dishes with hot||
8046|048|S|water, taking long walks, and rubbing your hands/feet. Tell your||
8046|049|S|doctor right away if you develop the following symptoms on your||
8046|050|S|hands/feet: redness, peeling skin, blisters, pain, numbness,||
8046|051|S|tingling, or swelling. If you develop these symptoms, consult||
8046|052|S|your doctor for treatment options (such as reducing your dose or||
8046|053|S|stopping fluorouracil therapy, applying ice packs to the||
8046|054|S|hands/feet).||
8046|055|S|   Tell your doctor right away if you have any serious side||
8046|056|S|effects, including: headache, mental/mood changes (such as||
8046|057|S|confusion), vision changes, unusual eye movements, loss of||
8046|058|S|coordination, unusual tiredness.||
8046|059|S|   Get medical help right away if you have any very serious side||
8046|060|S|effects, including: easy bruising/bleeding, blood in the urine,||
8046|061|S|black/bloody stools, vomit that looks like coffee grounds,||
8046|062|S|stomach/abdominal pain, chest pain, jaw/left arm pain,||
8046|063|S|fast/slow/irregular heartbeat, mouth sores, sore throat, painful||
8046|064|S|swallowing, heartburn, pain/redness/swelling of the arms/legs.||
8046|065|S|   This medication can lower the body's ability to fight an||
8046|066|S|infection. Tell your doctor right away if you develop any signs||
8046|067|S|of an infection (such as sore throat that doesn't go away, fever,||
8046|068|S|chills).||
8046|069|S|   A very serious allergic reaction to this drug is rare.||
8046|070|S|However, get medical help right away if you notice any symptoms||
8046|071|S|of a serious allergic reaction, including: rash, itching/swelling||
8046|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8046|073|S|breathing.||
8046|074|S|   Fluorouracil can commonly cause a rash that is usually not||
8046|075|S|serious. However, you may not be able to tell it apart from a||
8046|076|S|rare rash that could be a sign of a severe reaction. Get medical||
8046|077|S|help right away if you develop a rash.||
8046|078|S|   This is not a complete list of possible side effects. If you||
8046|079|S|notice other effects not listed above, contact your doctor or||
8046|080|S|pharmacist.||
8046|081|S|   In the US -||
8046|082|S|   Call your doctor for medical advice about side effects. You||
8046|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8046|084|S|www.fda.gov/medwatch.||
8046|085|S|   In Canada - Call your doctor for medical advice about side||
8046|086|S|effects. You may report side effects to Health Canada at||
8046|087|S|1-866-234-2345.||
8046|088|B|||
8046|089|P|PRECAUTIONS:  Before using fluorouracil, tell your doctor or||
8046|090|P|pharmacist if you are allergic to it; or to flucytosine; or to||
8046|091|P|capecitabine; or if you have any other allergies. This product||
8046|092|P|may contain inactive ingredients, which can cause allergic||
8046|093|P|reactions or other problems. Talk to your pharmacist for more||
8046|094|P|details.||
8046|095|P|   Before using this medication, tell your doctor or pharmacist||
8046|096|P|your medical history, especially of: poor nutrition, decreased||
8046|097|P|bone marrow function/blood cell disorders (such as anemia,||
8046|098|P|leukopenia, thrombocytopenia), a certain enzyme deficiency||
8046|099|P|(dihydropyrimidine dehydrogenase - DPD), a serious infection,||
8046|100|P|liver problems, kidney problems.||
8046|101|P|   Tell your health care professional that you are using||
8046|102|P|fluorouracil before having any immunizations/vaccinations. Avoid||
8046|103|P|contact with people who have recently received live vaccines||
8046|104|P|(such as flu vaccine inhaled through the nose).||
8046|105|P|   To lower the chance of getting cut, bruised, or injured, use||
8046|106|P|caution with sharp objects like razors and nail cutters, and||
8046|107|P|avoid activities such as contact sports.||
8046|108|P|   This medication may make you more sensitive to the sun. Limit||
8046|109|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8046|110|P|sunscreen and wear protective clothing when outdoors. Tell your||
8046|111|P|doctor right away if you get sunburned or have skin||
8046|112|P|blisters/redness.||
8046|113|P|   Tell your doctor if you are pregnant or plan to become||
8046|114|P|pregnant. You should not become pregnant while using||
8046|115|P|fluorouracil. Fluorouracil may harm an unborn baby. Men and women||
8046|116|P|using this medication should ask about reliable forms of birth||
8046|117|P|control during treatment and for some time after the last dose.||
8046|118|P|If you or your partner becomes pregnant, talk to your doctor||
8046|119|P|right away about the risks and benefits of this medication.||
8046|120|P|   It is unknown if this drug passes into breast milk. Because of||
8046|121|P|the possible risk to the infant, breastfeeding is not recommended||
8046|122|P|while using this drug. Consult your doctor before breastfeeding.||
8046|123|B|||
8046|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8046|125|I|medications work or increase your risk for serious side effects.||
8046|126|I|This document does not contain all possible drug interactions.||
8046|127|I|Keep a list of all the products you use (including||
8046|128|I|prescription/nonprescription drugs and herbal products) and share||
8046|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
8046|130|I|the dosage of any medicines without your doctor's approval.||
8046|131|I|   A product that may interact with this drug is: warfarin.||
8046|132|I|   Fluorouracil is very similar to flucytosine and capecitabine.||
8046|133|I|Do not use medications containing flucytosine or capecitabine||
8046|134|I|while using fluorouracil.||
8046|135|B|||
8046|136|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8046|137|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8046|138|O|poison control center right away. US residents can call||
8046|139|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8046|140|B|||
8046|141|N|NOTES:  Lab and/or medical tests (such as complete blood counts)||
8046|142|N|should be done while you are using this medication. Keep all||
8046|143|N|medical and lab appointments. Consult your doctor for more||
8046|144|N|details.||
8046|145|B|||
8046|146|D|MISSED DOSE:  It is important to get each dose of this medication||
8046|147|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8046|148|D|right away for a new dosing schedule.||
8046|149|B|||
8046|150|R|STORAGE:  Consult the product instructions and your pharmacist||
8046|151|R|for storage details. Keep all medications away from children and||
8046|152|R|pets.||
8046|153|R|   Do not flush medications down the toilet or pour them into a||
8046|154|R|drain unless instructed to do so. Properly discard this product||
8046|155|R|when it is expired or no longer needed. Consult your pharmacist||
8046|156|R|or local waste disposal company.||
8046|157|B|||
8046|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
8046|159|M|medical emergency. For information about enrolling in MedicAlert,||
8046|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8046|161|B|||
8046|162|A|Information last revised May 2025.||
8046|163|A|Copyright(c) 2025 First Databank, Inc.||
8046|164|B|||
8047|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8047|002|Z|does NOT have all possible information about this product. This||
8047|003|Z|information does not assure that this product is safe, effective,||
8047|004|Z|or appropriate for you. This information is not individual||
8047|005|Z|medical advice and does not substitute for the advice of your||
8047|006|Z|health care professional. Always ask your health care||
8047|007|Z|professional for complete information about this product and your||
8047|008|Z|specific health needs.||
8047|009|B|||
8047|010|T|CLOMIPRAMINE - ORAL||
8047|011|F|(klo-MIP-ruh-meen)||
8047|012|B|||
8047|013|C|COMMON BRAND NAME(S): Anafranil||
8047|014|B|||
8047|015|W|WARNING:  Antidepressant medications are used to treat a variety||
8047|016|W|of conditions, including depression and other mental/mood||
8047|017|W|disorders. These medications can help prevent suicidal||
8047|018|W|thoughts/attempts and provide other important benefits. However,||
8047|019|W|studies have shown that a small number of people (especially||
8047|020|W|people younger than 25) who take antidepressants for any||
8047|021|W|condition may experience worsening depression, other mental/mood||
8047|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
8047|023|W|talk with the doctor about the risks and benefits of||
8047|024|W|antidepressant medication (especially for people younger than||
8047|025|W|25), even if treatment is not for a mental/mood condition.||
8047|026|W|   Tell the doctor right away if you notice worsening||
8047|027|W|depression/other psychiatric conditions, unusual behavior changes||
8047|028|W|(including possible suicidal thoughts/attempts), or other||
8047|029|W|mental/mood changes (including new/worsening anxiety, panic||
8047|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
8047|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
8047|032|W|especially watchful for these symptoms when a new antidepressant||
8047|033|W|is started or when the dose is changed.||
8047|034|B|||
8047|035|U|USES:  This medication is used to treat obsessive compulsive||
8047|036|U|disorder (OCD). Clomipramine belongs to a class of drugs known as||
8047|037|U|tricyclic antidepressants. It works by helping to restore the||
8047|038|U|balance of certain natural substances in the brain.||
8047|039|B|||
8047|040|V|OTHER USES:  This section contains uses of this drug that are not||
8047|041|V|listed in the approved professional labeling for the drug but||
8047|042|V|that may be prescribed by your health care professional. Use this||
8047|043|V|drug for a condition that is listed in this section only if it||
8047|044|V|has been so prescribed by your health care professional.||
8047|045|V|   This drug may also be used for depression, panic attacks, or||
8047|046|V|ongoing pain.||
8047|047|B|||
8047|048|H|HOW TO USE:  Read the Medication Guide provided by your||
8047|049|H|pharmacist before you start taking clomipramine and each time you||
8047|050|H|get a refill. If you have any questions, ask your doctor or||
8047|051|H|pharmacist.||
8047|052|H|   Take this medication by mouth with or without food as directed||
8047|053|H|by your doctor. To lessen side effects such as stomach upset,||
8047|054|H|clomipramine may be started at a low dose, given in several doses||
8047|055|H|during the day with meals, and slowly increased as your body gets||
8047|056|H|used to it. After you have reached the best dose for you, the||
8047|057|H|total dose can be taken once daily as directed by your doctor,||
8047|058|H|usually at bedtime to prevent daytime drowsiness.||
8047|059|H|   Follow your doctor's instructions carefully. Do not take more||
8047|060|H|or less medication or take it more often than prescribed. Your||
8047|061|H|condition will not improve any faster and your risk of side||
8047|062|H|effects such as seizures may be increased. The dosage is based on||
8047|063|H|your medical condition and response to treatment.||
8047|064|H|   Avoid eating grapefruit or drinking grapefruit juice while||
8047|065|H|using this medication unless your doctor or pharmacist says you||
8047|066|H|may do so safely. Grapefruit can increase the chance of side||
8047|067|H|effects with this medicine. Ask your doctor or pharmacist for||
8047|068|H|more details.||
8047|069|H|   Use this medication regularly in order to get the most benefit||
8047|070|H|from it. Keep taking it even if you feel well. To help you||
8047|071|H|remember, use it at the same time(s) each day.||
8047|072|H|   Do not suddenly stop taking this medication without consulting||
8047|073|H|your doctor. Some conditions may become worse when the drug is||
8047|074|H|abruptly stopped. You may experience sweating, dizziness, nausea,||
8047|075|H|vomiting, headache, or irritability if you suddenly stop taking||
8047|076|H|this drug. Your dose may need to be gradually decreased.||
8047|077|H|   It may take 2 to 3 weeks or longer before you notice the full||
8047|078|H|effects of this medication. Tell your doctor if your condition||
8047|079|H|lasts or gets worse.||
8047|080|B|||
8047|081|S|SIDE EFFECTS:  See also Warning section.||
8047|082|S|   Dizziness, drowsiness, dry mouth, constipation, stomach upset,||
8047|083|S|nausea, vomiting, changes in appetite/weight, flushing, sweating,||
8047|084|S|tiredness and blurred vision may occur. Anxiety symptoms may||
8047|085|S|temporarily worsen when you first start taking clomipramine. If||
8047|086|S|any of these effects last or get worse, tell your doctor or||
8047|087|S|pharmacist promptly.||
8047|088|S|   To reduce the risk of dizziness and lightheadedness, get up||
8047|089|S|slowly when rising from a sitting or lying position.||
8047|090|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
8047|091|S|chips, chew (sugarless) gum, drink water or use a saliva||
8047|092|S|substitute.||
8047|093|S|   To prevent constipation, eat dietary fiber, drink enough||
8047|094|S|water, and exercise. You may also need to take a laxative. Ask||
8047|095|S|your pharmacist which type of laxative is right for you.||
8047|096|S|   Remember that this medication has been prescribed because your||
8047|097|S|doctor has judged that the benefit to you is greater than the||
8047|098|S|risk of side effects. Many people using this medication do not||
8047|099|S|have serious side effects.||
8047|100|S|   Tell your doctor right away if you have any serious side||
8047|101|S|effects, including: mental/mood changes (such as confusion,||
8047|102|S|depression, memory problems), enlarged/painful breasts, unwanted||
8047|103|S|breast milk production, irregular/painful menstrual periods,||
8047|104|S|muscle stiffness, ringing in the ears, sexual problems (such as||
8047|105|S|decreased sexual ability, changes in desire), shakiness||
8047|106|S|(tremors), numbness/tingling of the hands/feet, trouble||
8047|107|S|urinating, easy bleeding/bruising, unusual/uncontrolled movements||
8047|108|S|(especially of the tongue/face/lips), severe stomach/abdominal||
8047|109|S|pain, dark urine, yellowing of eyes/skin.||
8047|110|S|   This medication may increase serotonin and rarely cause a very||
8047|111|S|serious condition called serotonin syndrome/toxicity. The risk||
8047|112|S|increases if you are also taking other drugs that increase||
8047|113|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
8047|114|S|take. Get medical help right away if you develop some of the||
8047|115|S|following symptoms: fast heartbeat, hallucinations, loss of||
8047|116|S|coordination, severe dizziness, severe nausea/vomiting/diarrhea,||
8047|117|S|twitching muscles, unexplained fever, unusual||
8047|118|S|agitation/restlessness.||
8047|119|S|   Get medical help right away if you have any very serious side||
8047|120|S|effects, including: black stools, chest pain, fainting,||
8047|121|S|slow/fast/irregular heartbeat, seizures, vomit that looks like||
8047|122|S|coffee grounds, eye pain/swelling/redness, widened pupils, vision||
8047|123|S|changes (such as seeing rainbows around lights at night).||
8047|124|S|   A very serious allergic reaction to this drug is rare.||
8047|125|S|However, get medical help right away if you notice any symptoms||
8047|126|S|of a serious allergic reaction, including: fever, swollen lymph||
8047|127|S|nodes, rash, itching/swelling (especially of the||
8047|128|S|face/tongue/throat), severe dizziness, trouble breathing.||
8047|129|S|   This is not a complete list of possible side effects. If you||
8047|130|S|notice other effects not listed above, contact your doctor or||
8047|131|S|pharmacist.||
8047|132|S|   In the US -||
8047|133|S|   Call your doctor for medical advice about side effects. You||
8047|134|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8047|135|S|www.fda.gov/medwatch.||
8047|136|S|   In Canada - Call your doctor for medical advice about side||
8047|137|S|effects. You may report side effects to Health Canada at||
8047|138|S|1-866-234-2345.||
8047|139|B|||
8047|140|P|PRECAUTIONS:  See also Warning section.||
8047|141|P|   Before taking clomipramine, tell your doctor or pharmacist if||
8047|142|P|you are allergic to it; or to other tricyclic antidepressants||
8047|143|P|(such as imipramine, nortriptyline); or if you have any other||
8047|144|P|allergies. This product may contain inactive ingredients, which||
8047|145|P|can cause allergic reactions or other problems. Talk to your||
8047|146|P|pharmacist for more details.||
8047|147|P|   Before using this medication, tell your doctor or pharmacist||
8047|148|P|your medical history, especially of: bleeding problems, blood||
8047|149|P|problems (such as purpura, thrombocytopenia), breathing problems||
8047|150|P|(such as asthma, chronic bronchitis), personal or family history||
8047|151|P|of glaucoma (angle-closure type), eating disorders (such as||
8047|152|P|bulimia), heart problems (such as arrhythmias, coronary artery||
8047|153|P|disease, recent heart attack), intestinal problems (such as||
8047|154|P|chronic constipation, ileus), liver problems, kidney problems,||
8047|155|P|personal or family history of other mental/mood conditions (such||
8047|156|P|as bipolar disorder, schizophrenia), history of hospitalization||
8047|157|P|for a very serious reaction to certain medications (neuroleptic||
8047|158|P|malignant syndrome), heartburn/stomach acid in the esophagus||
8047|159|P|(such as due to hiatal hernia), seizures, overactive thyroid||
8047|160|P|(hyperthyroidism), trouble urinating (urinary retention, enlarged||
8047|161|P|prostate), any condition that may increase your risk of seizures||
8047|162|P|(such as alcohol/sedative dependency, use of electroconvulsive||
8047|163|P|therapy, brain injury/disease), certain types of tumors (such as||
8047|164|P|pheochromocytoma, neuroblastoma).||
8047|165|P|   Clomipramine may cause a condition that affects the heart||
8047|166|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8047|167|P|serious (rarely fatal) fast/irregular heartbeat and other||
8047|168|P|symptoms (such as severe dizziness, fainting) that need medical||
8047|169|P|attention right away.||
8047|170|P|   The risk of QT prolongation may be increased if you have||
8047|171|P|certain medical conditions or are taking other drugs that may||
8047|172|P|cause QT prolongation. Before using clomipramine, tell your||
8047|173|P|doctor or pharmacist of all the drugs you take and if you have||
8047|174|P|any of the following conditions: certain heart problems (heart||
8047|175|P|failure, slow heartbeat, QT prolongation in the EKG), family||
8047|176|P|history of certain heart problems (QT prolongation in the EKG,||
8047|177|P|sudden cardiac death).||
8047|178|P|   Low levels of potassium or magnesium in the blood may also||
8047|179|P|increase your risk of QT prolongation. This risk may increase if||
8047|180|P|you use certain drugs (such as diuretics/"water pills") or if you||
8047|181|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8047|182|P|Talk to your doctor about using clomipramine safely.||
8047|183|P|   This drug may make you dizzy or drowsy or temporarily blur||
8047|184|P|your vision. Alcohol or marijuana (cannabis) can make you more||
8047|185|P|dizzy or drowsy. Do not drive, use machinery, or do anything that||
8047|186|P|needs alertness or clear vision until you can do it safely. Limit||
8047|187|P|alcoholic beverages. Talk to your doctor if you are using||
8047|188|P|marijuana (cannabis).||
8047|189|P|   Before having surgery, tell your doctor or dentist about all||
8047|190|P|the products you use (including prescription drugs,||
8047|191|P|nonprescription drugs, and herbal products).||
8047|192|P|   Older adults may be more sensitive to the side effects of this||
8047|193|P|drug, especially bleeding, confusion, dizziness, and QT||
8047|194|P|prolongation (see above). Dizziness and confusion can increase||
8047|195|P|the risk of falling. Older adults may also be more likely to||
8047|196|P|develop low sodium in the blood, especially if they are taking||
8047|197|P|"water pills" (diuretics).||
8047|198|P|   During pregnancy, this medication should be used only when||
8047|199|P|clearly needed. Newborns exposed to clomipramine during pregnancy||
8047|200|P|may experience withdrawal symptoms or side effects. Discuss the||
8047|201|P|risks and benefits with your doctor. Tell your doctor right away||
8047|202|P|if you notice jitteriness, shaking, feeding problems, fast||
8047|203|P|breathing, or seizures in your newborn.||
8047|204|P|   Since untreated mental/mood problems (such as obsessive||
8047|205|P|compulsive disorder, depression, panic attack) can be a serious||
8047|206|P|condition, do not stop taking this medication unless directed by||
8047|207|P|your doctor. If you are planning pregnancy, become pregnant, or||
8047|208|P|think you may be pregnant, immediately discuss with your doctor||
8047|209|P|the benefits and risks of using this medication during pregnancy.||
8047|210|P|   This drug passes into breast milk and may have undesirable||
8047|211|P|effects on a nursing infant. Consult your doctor before||
8047|212|P|breastfeeding.||
8047|213|B|||
8047|214|I|DRUG INTERACTIONS:  See also the How to Use section.||
8047|215|I|   Drug interactions may change how your medications work or||
8047|216|I|increase your risk for serious side effects. This document does||
8047|217|I|not contain all possible drug interactions. Keep a list of all||
8047|218|I|the products you use (including prescription/nonprescription||
8047|219|I|drugs and herbal products) and share it with your doctor and||
8047|220|I|pharmacist. Do not start, stop, or change the dosage of any||
8047|221|I|medicines without your doctor's approval.||
8047|222|I|   Some products that may interact with this drug are: certain||
8047|223|I|drugs for high blood pressure (such as clonidine, guanethidine),||
8047|224|I|digoxin, thyroid supplements, valproic acid, other drugs that can||
8047|225|I|cause bleeding/bruising (including antiplatelet drugs such as||
8047|226|I|clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners"||
8047|227|I|such as dabigatran/warfarin).||
8047|228|I|   Taking MAO inhibitors with this medication may cause a serious||
8047|229|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
8047|230|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8047|231|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8047|232|I|selegiline, tranylcypromine) during treatment with this||
8047|233|I|medication. Most MAO inhibitors should also not be taken for two||
8047|234|I|weeks before and after treatment with this medication. Ask your||
8047|235|I|doctor when to start or stop taking this medication.||
8047|236|I|   The risk of serotonin syndrome/toxicity increases if you are||
8047|237|I|also taking other drugs that increase serotonin. Examples include||
8047|238|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
8047|239|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
8047|240|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
8047|241|I|serotonin syndrome/toxicity may be more likely when you start or||
8047|242|I|increase the dose of these drugs.||
8047|243|I|   Many drugs besides clomipramine may affect the heart rhythm||
8047|244|I|(QT prolongation), including amiodarone, dofetilide, quinidine,||
8047|245|I|sotalol, pimozide, procainamide, macrolide antibiotics (such as||
8047|246|I|erythromycin), among others. Before using clomipramine, report||
8047|247|I|all medications you are currently using to your doctor or||
8047|248|I|pharmacist.||
8047|249|I|   Other medications can affect the removal of clomipramine from||
8047|250|I|your body, which may affect how clomipramine works. Examples||
8047|251|I|include artemether/lumefantrine, barbiturates (such as||
8047|252|I|phenobarbital), cimetidine, haloperidol, certain drugs for heart||
8047|253|I|rhythm (such as flecainide/propafenone), certain HIV protease||
8047|254|I|inhibitors (such as fosamprenavir), phenothiazines (such as||
8047|255|I|thioridazine), certain anti-seizure drugs (such as phenytoin).||
8047|256|I|   Tell your doctor or pharmacist if you are taking other||
8047|257|I|products that cause drowsiness including alcohol, marijuana||
8047|258|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
8047|259|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
8047|260|I|zolpidem), muscle relaxants (such as carisoprodol,||
8047|261|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
8047|262|I|hydrocodone).||
8047|263|I|   Aspirin can increase the risk of bleeding when used with this||
8047|264|I|medication. However, if your doctor has told you to take low-dose||
8047|265|I|aspirin to prevent heart attack or stroke (usually 81-162||
8047|266|I|milligrams a day), you should keep taking the aspirin unless your||
8047|267|I|doctor tells you not to. Ask your doctor or pharmacist for more||
8047|268|I|details.||
8047|269|I|   Check the labels on all your medicines (such as allergy or||
8047|270|I|cough-and-cold products) because they may contain ingredients||
8047|271|I|that cause drowsiness. Ask your pharmacist about using those||
8047|272|I|products safely.||
8047|273|I|   Cigarette smoking decreases blood levels of this medication.||
8047|274|I|Tell your doctor if you smoke or if you have recently stopped||
8047|275|I|smoking.||
8047|276|B|||
8047|277|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8047|278|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8047|279|O|poison control center right away. US residents can call||
8047|280|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8047|281|O|Symptoms of overdose may include: fast/irregular heartbeat,||
8047|282|O|severe dizziness, fainting, delirium, seizures, loss of||
8047|283|O|consciousness.||
8047|284|B|||
8047|285|N|NOTES:  Do not share this medication with others.||
8047|286|N|   Lab and/or medical tests (such as EKG, liver function, blood||
8047|287|N|counts) may be done while you are taking this medication. Keep||
8047|288|N|all medical and lab appointments. Consult your doctor for more||
8047|289|N|details.||
8047|290|B|||
8047|291|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8047|292|D|remember. If it is near the time of the next dose, skip the||
8047|293|D|missed dose. Take your next dose at the regular time. Do not||
8047|294|D|double the dose to catch up.||
8047|295|B|||
8047|296|R|STORAGE:  Store at room temperature away from light and moisture.||
8047|297|R|Do not store in the bathroom. Keep all medications away from||
8047|298|R|children and pets.||
8047|299|R|   Do not flush medications down the toilet or pour them into a||
8047|300|R|drain unless instructed to do so. Properly discard this product||
8047|301|R|when it is expired or no longer needed. Consult your pharmacist||
8047|302|R|or local waste disposal company.||
8047|303|B|||
8047|304|A|Information last revised October 2024.||
8047|305|A|Copyright(c) 2025 First Databank, Inc.||
8047|306|B|||
8048|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8048|002|Z|does NOT have all possible information about this product. This||
8048|003|Z|information does not assure that this product is safe, effective,||
8048|004|Z|or appropriate for you. This information is not individual||
8048|005|Z|medical advice and does not substitute for the advice of your||
8048|006|Z|health care professional. Always ask your health care||
8048|007|Z|professional for complete information about this product and your||
8048|008|Z|specific health needs.||
8048|009|B|||
8048|010|T|NITROGLYCERIN EXTENDED-RELEASE CAPSULE - ORAL||
8048|011|F|(NYE-troe-GLIS-er-in)||
8048|012|B|||
8048|013|C|COMMON BRAND NAME(S): Nitro-Bid, Nitroglyn||
8048|014|B|||
8048|015|U|USES:  Nitroglycerin extended-release capsules are used to||
8048|016|U|prevent chest pain (angina) in people with a certain heart||
8048|017|U|condition (coronary artery disease). This medication belongs to a||
8048|018|U|class of drugs known as nitrates. Angina occurs when the heart||
8048|019|U|muscle is not getting enough blood. This drug works by relaxing||
8048|020|U|and widening blood vessels so blood can flow more easily to the||
8048|021|U|heart.||
8048|022|U|   This medication will not relieve chest pain once it occurs. It||
8048|023|U|is also not intended to be taken just before physical activities||
8048|024|U|(such as exercise, sexual activity) to prevent chest pain. Other||
8048|025|U|medications may be needed in these situations. Consult your||
8048|026|U|doctor for more details.||
8048|027|B|||
8048|028|H|HOW TO USE:  Take this medication by mouth as directed by your||
8048|029|H|doctor, usually 3 to 4 times daily. It is important to take the||
8048|030|H|drug at the same times each day. Do not change the dosing times||
8048|031|H|unless directed by your doctor. The dosage is based on your||
8048|032|H|medical condition and response to treatment.||
8048|033|H|   Swallow this medication whole. Do not crush or chew the||
8048|034|H|capsules. Doing so can release all of the drug at once and may||
8048|035|H|increase your risk of side effects.||
8048|036|H|   Use this medication regularly to get the most benefit from it.||
8048|037|H|Do not suddenly stop taking this medication without consulting||
8048|038|H|your doctor. Some conditions may become worse when the drug is||
8048|039|H|suddenly stopped. Your dose may need to be gradually decreased.||
8048|040|H|   Although unlikely, when this medication is used for a long||
8048|041|H|time, it may not work as well and may require different dosing.||
8048|042|H|Tell your doctor if this medication stops working well (for||
8048|043|H|example, you have worsening chest pain or it occurs more often).||
8048|044|B|||
8048|045|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, nausea, and||
8048|046|S|flushing may occur as your body adjusts to this medication. If||
8048|047|S|any of these effects last or get worse, tell your doctor or||
8048|048|S|pharmacist promptly.||
8048|049|S|   Headache is often a sign that this medication is working. Your||
8048|050|S|doctor may recommend treating headaches with an over-the-counter||
8048|051|S|pain reliever (such as acetaminophen, aspirin). If the headaches||
8048|052|S|continue or become severe, tell your doctor promptly.||
8048|053|S|   To reduce the risk of dizziness and lightheadedness, get up||
8048|054|S|slowly when rising from a sitting or lying position.||
8048|055|S|   Remember that this medication has been prescribed because your||
8048|056|S|doctor has judged that the benefit to you is greater than the||
8048|057|S|risk of side effects. Many people using this medication do not||
8048|058|S|have serious side effects.||
8048|059|S|   Tell your doctor right away if you have any serious side||
8048|060|S|effects, including: fainting, fast/irregular/pounding heartbeat.||
8048|061|S|   A very serious allergic reaction to this drug is rare.||
8048|062|S|However, get medical help right away if you notice any symptoms||
8048|063|S|of a serious allergic reaction, including: rash, itching/swelling||
8048|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8048|065|S|breathing.||
8048|066|S|   This is not a complete list of possible side effects. If you||
8048|067|S|notice other effects not listed above, contact your doctor or||
8048|068|S|pharmacist.||
8048|069|S|   In the US -||
8048|070|S|   Call your doctor for medical advice about side effects. You||
8048|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8048|072|S|www.fda.gov/medwatch.||
8048|073|S|   In Canada - Call your doctor for medical advice about side||
8048|074|S|effects. You may report side effects to Health Canada at||
8048|075|S|1-866-234-2345.||
8048|076|B|||
8048|077|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
8048|078|P|pharmacist if you are allergic to it; or to similar drugs (such||
8048|079|P|as isosorbide mononitrate); or to nitrites; or if you have any||
8048|080|P|other allergies. This product may contain inactive ingredients,||
8048|081|P|which can cause allergic reactions or other problems. Talk to||
8048|082|P|your pharmacist for more details.||
8048|083|P|   Before using this medication, tell your doctor or pharmacist||
8048|084|P|your medical history, especially of: recent head injury, frequent||
8048|085|P|stomach cramping/watery stools/severe diarrhea (GI||
8048|086|P|hypermotility), lack of proper absorption of nutrients||
8048|087|P|(malabsorption), anemia, low blood pressure, dehydration, other||
8048|088|P|heart problems (such as recent heart attack).||
8048|089|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8048|090|P|can make you more dizzy. Do not drive, use machinery, or do||
8048|091|P|anything that needs alertness until you can do it safely. Limit||
8048|092|P|alcoholic beverages. Talk to your doctor if you are using||
8048|093|P|marijuana (cannabis).||
8048|094|P|   Before having surgery, tell your doctor or dentist about all||
8048|095|P|the products you use (including prescription drugs,||
8048|096|P|nonprescription drugs, and herbal products).||
8048|097|P|   Older adults may be more sensitive to the side effects of this||
8048|098|P|medication, especially dizziness and lightheadedness, which could||
8048|099|P|increase the risk of falls.||
8048|100|P|   During pregnancy, this medication should be used only when||
8048|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
8048|102|P|   It is unknown if this drug passes into breast milk. Consult||
8048|103|P|your doctor before breastfeeding.||
8048|104|B|||
8048|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8048|106|I|medications work or increase your risk for serious side effects.||
8048|107|I|This document does not contain all possible drug interactions.||
8048|108|I|Keep a list of all the products you use (including||
8048|109|I|prescription/nonprescription drugs and herbal products) and share||
8048|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
8048|111|I|the dosage of any medicines without your doctor's approval.||
8048|112|I|   Some products that may interact with this drug include: drugs||
8048|113|I|used to treat erectile dysfunction-ED or pulmonary hypertension||
8048|114|I|(such as sildenafil, tadalafil), certain drugs to treat migraine||
8048|115|I|headaches (ergot alkaloids such as ergotamine), riociguat,||
8048|116|I|vericiguat.||
8048|117|I|   This medication may interfere with certain lab tests (such as||
8048|118|I|blood cholesterol levels), possibly causing false test results.||
8048|119|I|Make sure lab personnel and all your doctors know you use this||
8048|120|I|drug.||
8048|121|B|||
8048|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8048|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8048|124|O|poison control center right away. US residents can call||
8048|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8048|126|O|Symptoms of overdose may include: slow heartbeat, vision changes,||
8048|127|O|severe nausea/vomiting, sweating, cold/clammy skin, bluish||
8048|128|O|fingers/toes/lips.||
8048|129|B|||
8048|130|N|NOTES:  Do not share this medication with others.||
8048|131|N|   Lab and/or medical tests (such as blood pressure monitoring)||
8048|132|N|should be done while you are taking this medication. Keep all||
8048|133|N|medical and lab appointments. Consult your doctor for more||
8048|134|N|details.||
8048|135|N|   Lifestyle changes such as dietary changes, exercise, and||
8048|136|N|stopping smoking may help this drug work better. Talk to your||
8048|137|N|doctor or pharmacist about lifestyle changes that might benefit||
8048|138|N|you.||
8048|139|B|||
8048|140|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8048|141|D|remember. If it is near the time of the next dose, skip the||
8048|142|D|missed dose. Take your next dose at the regular time. Do not||
8048|143|D|double the dose to catch up.||
8048|144|B|||
8048|145|R|STORAGE:  Store at room temperature away from light and moisture.||
8048|146|R|Do not store in the bathroom. Keep all medications away from||
8048|147|R|children and pets.||
8048|148|R|   Do not flush medications down the toilet or pour them into a||
8048|149|R|drain unless instructed to do so. Properly discard this product||
8048|150|R|when it is expired or no longer needed. Consult your pharmacist||
8048|151|R|or local waste disposal company.||
8048|152|B|||
8048|153|M|MEDICAL ALERT:  Your condition can cause complications in a||
8048|154|M|medical emergency. For information about enrolling in MedicAlert,||
8048|155|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8048|156|B|||
8048|157|A|Information last revised May 2024.||
8048|158|A|Copyright(c) 2025 First Databank, Inc.||
8048|159|B|||
8051|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8051|002|Z|does NOT have all possible information about this product. This||
8051|003|Z|information does not assure that this product is safe, effective,||
8051|004|Z|or appropriate for you. This information is not individual||
8051|005|Z|medical advice and does not substitute for the advice of your||
8051|006|Z|health care professional. Always ask your health care||
8051|007|Z|professional for complete information about this product and your||
8051|008|Z|specific health needs.||
8051|009|B|||
8051|010|T|SUMATRIPTAN TABLET - ORAL||
8051|011|F|(SOO-ma-TRIP-tan)||
8051|012|B|||
8051|013|C|COMMON BRAND NAME(S): Imitrex||
8051|014|B|||
8051|015|U|USES:  Sumatriptan is used to treat migraines. It helps to||
8051|016|U|relieve headache, pain, and other migraine symptoms (including||
8051|017|U|nausea, vomiting, sensitivity to light/sound). Prompt treatment||
8051|018|U|helps you return to your normal routine and may decrease your||
8051|019|U|need for other pain medications. Sumatriptan belongs to a class||
8051|020|U|of drugs known as triptans. It affects a certain natural||
8051|021|U|substance (serotonin) that causes narrowing of blood vessels in||
8051|022|U|the brain. It may also relieve pain by affecting certain nerves||
8051|023|U|in the brain.||
8051|024|U|   Sumatriptan does not prevent future migraines or lessen how||
8051|025|U|often you get migraine attacks.||
8051|026|B|||
8051|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8051|028|H|from your pharmacist before you start taking sumatriptan and each||
8051|029|H|time you get a refill. If you have any questions, ask your doctor||
8051|030|H|or pharmacist.||
8051|031|H|   Take this medication by mouth with or without food as directed||
8051|032|H|by your doctor, at the first sign of a migraine. The dosage is||
8051|033|H|based on your medical condition and response to treatment. If||
8051|034|H|there is no improvement in your symptoms, do not take more doses||
8051|035|H|of this medication before talking to your doctor. If your||
8051|036|H|symptoms are only partly relieved, or if your headache comes||
8051|037|H|back, you may take another dose at least two hours after the||
8051|038|H|first dose. Do not take more than 200 milligrams in a 24-hour||
8051|039|H|period.||
8051|040|H|   This medication may also be used as a backup for sumatriptan||
8051|041|H|injection. If your symptoms are only partly relieved or your||
8051|042|H|headache comes back, you may take a dose of sumatriptan by mouth||
8051|043|H|at least two hours after the injection, up to a maximum of 100||
8051|044|H|milligrams in a 24-hour period.||
8051|045|H|   If you have a higher risk for heart problems (see||
8051|046|H|Precautions), your doctor may perform a heart exam before you||
8051|047|H|start taking sumatriptan. He/she may also direct you to take your||
8051|048|H|first dose of this medication in the office/clinic to monitor for||
8051|049|H|serious side effects (such as chest pain). Talk to your doctor||
8051|050|H|for details.||
8051|051|H|   If you are using drugs for migraine attacks on 10 or more days||
8051|052|H|each month, the drugs may actually make your headaches worse||
8051|053|H|(medication overuse headache). Do not use medications more often||
8051|054|H|or for longer than directed. Tell your doctor if you need to use||
8051|055|H|this medication more often, or if the medication is not working||
8051|056|H|as well, or if your headaches get worse.||
8051|057|B|||
8051|058|S|SIDE EFFECTS:  Flushing, feelings of||
8051|059|S|tingling/numbness/prickling/heat, tiredness, weakness,||
8051|060|S|drowsiness, or dizziness may occur. If any of these effects last||
8051|061|S|or get worse, tell your doctor or pharmacist promptly.||
8051|062|S|   Remember that this medication has been prescribed because your||
8051|063|S|doctor has judged that the benefit to you is greater than the||
8051|064|S|risk of side effects. Many people using this medication do not||
8051|065|S|have serious side effects.||
8051|066|S|   This medication may raise your blood pressure. Check your||
8051|067|S|blood pressure regularly and tell your doctor if the results are||
8051|068|S|high.||
8051|069|S|   Tell your doctor right away if you have any serious side||
8051|070|S|effects, including: blue fingers/toes/nails, cold hands/feet,||
8051|071|S|hearing changes, mental/mood changes.||
8051|072|S|   Sumatriptan can commonly cause chest/jaw/neck tightness, pain,||
8051|073|S|or pressure that is usually not serious. However, these side||
8051|074|S|effects are like symptoms of a heart attack, which may include||
8051|075|S|chest/jaw/left arm pain, shortness of breath, or unusual||
8051|076|S|sweating. Get medical help right away if these or other serious||
8051|077|S|side effects occur, including: fast/irregular heartbeat,||
8051|078|S|fainting, severe stomach/abdominal pain, bloody diarrhea,||
8051|079|S|seizure, signs of a stroke (such as weakness on one side of the||
8051|080|S|body, trouble speaking, sudden vision changes, confusion).||
8051|081|S|   This medication may increase serotonin and rarely cause a very||
8051|082|S|serious condition called serotonin syndrome/toxicity. The risk||
8051|083|S|increases if you are also taking other drugs that increase||
8051|084|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
8051|085|S|take (see Drug Interactions section). Get medical help right away||
8051|086|S|if you develop some of the following symptoms: fast heartbeat,||
8051|087|S|hallucinations, loss of coordination, severe dizziness, severe||
8051|088|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
8051|089|S|unusual agitation/restlessness.||
8051|090|S|   A very serious allergic reaction to this drug is rare.||
8051|091|S|However, get medical help right away if you notice any symptoms||
8051|092|S|of a serious allergic reaction, including: rash, itching/swelling||
8051|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8051|094|S|breathing.||
8051|095|S|   This is not a complete list of possible side effects. If you||
8051|096|S|notice other effects not listed above, contact your doctor or||
8051|097|S|pharmacist.||
8051|098|S|   In the US -||
8051|099|S|   Call your doctor for medical advice about side effects. You||
8051|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8051|101|S|www.fda.gov/medwatch.||
8051|102|S|   In Canada - Call your doctor for medical advice about side||
8051|103|S|effects. You may report side effects to Health Canada at||
8051|104|S|1-866-234-2345.||
8051|105|B|||
8051|106|P|PRECAUTIONS:  Before using sumatriptan, tell your doctor or||
8051|107|P|pharmacist if you are allergic to it; or if you have any other||
8051|108|P|allergies. This product may contain inactive ingredients, which||
8051|109|P|can cause allergic reactions or other problems. Talk to your||
8051|110|P|pharmacist for more details.||
8051|111|P|   Before using this medication, tell your doctor or pharmacist||
8051|112|P|your medical history, especially of: blood circulation problems||
8051|113|P|(for example, in your legs, arms/hands, or stomach), certain||
8051|114|P|types of headaches (hemiplegic or basilar migraine), heart||
8051|115|P|problems (such as chest pain, irregular heartbeat, previous heart||
8051|116|P|attack), liver disease, seizure, stroke or "mini-stroke"||
8051|117|P|(transient ischemic attack).||
8051|118|P|   Certain conditions can increase your risk for heart problems.||
8051|119|P|Tell your doctor if you have any of these conditions, including:||
8051|120|P|high blood pressure, high cholesterol, diabetes, family history||
8051|121|P|of heart disease, overweight, smoker, postmenopausal (women), age||
8051|122|P|more than 40 years (men).||
8051|123|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8051|124|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8051|125|P|machinery, or do anything that needs alertness until you can do||
8051|126|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8051|127|P|are using marijuana (cannabis).||
8051|128|P|   Before having surgery, tell your doctor or dentist about all||
8051|129|P|the products you use (including prescription drugs,||
8051|130|P|nonprescription drugs, and herbal products).||
8051|131|P|   The risk of heart disease, liver disease, and high blood||
8051|132|P|pressure increases with age. Older adults may be more sensitive||
8051|133|P|to the side effects of this drug, especially increased blood||
8051|134|P|pressure and heart problems.||
8051|135|P|   During pregnancy, this medication should be used only when||
8051|136|P|clearly needed. Discuss the risks and benefits with your doctor.||
8051|137|P|   This drug passes into breast milk in small amounts. Consult||
8051|138|P|your doctor before breastfeeding.||
8051|139|B|||
8051|140|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8051|141|I|medications work or increase your risk for serious side effects.||
8051|142|I|This document does not contain all possible drug interactions.||
8051|143|I|Keep a list of all the products you use (including||
8051|144|I|prescription/nonprescription drugs and herbal products) and share||
8051|145|I|it with your doctor and pharmacist. Do not start, stop, or change||
8051|146|I|the dosage of any medicines without your doctor's approval.||
8051|147|I|   Taking MAO inhibitors with this medication may cause a serious||
8051|148|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
8051|149|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8051|150|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8051|151|I|selegiline, tranylcypromine) during treatment with this||
8051|152|I|medication. Most MAO inhibitors should also not be taken for two||
8051|153|I|weeks before treatment with this medication. Ask your doctor when||
8051|154|I|to start or stop taking this medication.||
8051|155|I|   The risk of serotonin syndrome/toxicity increases if you are||
8051|156|I|also taking other drugs that increase serotonin. Examples include||
8051|157|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
8051|158|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
8051|159|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
8051|160|I|serotonin syndrome/toxicity may be more likely when you start or||
8051|161|I|increase the dose of these drugs.||
8051|162|I|   If you also take any ergotamine medication (such as||
8051|163|I|dihydroergotamine) or other "triptan" drugs (such as||
8051|164|I|zolmitriptan, rizatriptan), you will need to separate your||
8051|165|I|sumatriptan dose from your dose of these other medications to||
8051|166|I|lessen the chance of serious side effects. Ask your doctor how||
8051|167|I|long you should wait between your doses of these drugs.||
8051|168|B|||
8051|169|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8051|170|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8051|171|O|poison control center right away. US residents can call||
8051|172|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8051|173|B|||
8051|174|N|NOTES:  Do not share this medication with others.||
8051|175|N|   Certain foods, beverages, or food additives (such as red wine,||
8051|176|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
8051|177|N|patterns such as irregular eating/sleeping habits or stress may||
8051|178|N|bring on a migraine headache. Avoiding these "triggers" may help||
8051|179|N|lessen migraine attacks. Consult your doctor for more details.||
8051|180|N|   Lab and/or medical tests (such as blood pressure) may be done||
8051|181|N|while you are taking this medication. Keep all medical and lab||
8051|182|N|appointments. Consult your doctor for more details.||
8051|183|B|||
8051|184|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
8051|185|B|||
8051|186|R|STORAGE:  Different brands of this medication have different||
8051|187|R|storage needs. Check the product package for instructions on how||
8051|188|R|to store your brand, or ask your pharmacist. Keep all medications||
8051|189|R|away from children and pets.||
8051|190|R|   Do not flush medications down the toilet or pour them into a||
8051|191|R|drain unless instructed to do so. Properly discard this product||
8051|192|R|when it is expired or no longer needed. Consult your pharmacist||
8051|193|R|or local waste disposal company.||
8051|194|B|||
8051|195|A|Information last revised May 2024.||
8051|196|A|Copyright(c) 2025 First Databank, Inc.||
8051|197|B|||
8052|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8052|002|Z|does NOT have all possible information about this product. This||
8052|003|Z|information does not assure that this product is safe, effective,||
8052|004|Z|or appropriate for you. This information is not individual||
8052|005|Z|medical advice and does not substitute for the advice of your||
8052|006|Z|health care professional. Always ask your health care||
8052|007|Z|professional for complete information about this product and your||
8052|008|Z|specific health needs.||
8052|009|B|||
8052|010|T|NYSTATIN TABLET - ORAL||
8052|011|F|(NYE-stat-in)||
8052|012|B|||
8052|013|C|COMMON BRAND NAME(S): Mycostatin||
8052|014|B|||
8052|015|U|USES:  This medication is used to treat fungal infections in the||
8052|016|U|stomach or intestines. Nystatin is an antifungal that works by||
8052|017|U|stopping the growth of fungus.||
8052|018|U|   Nystatin tablets should not be used to treat fungal infections||
8052|019|U|of the blood.||
8052|020|B|||
8052|021|H|HOW TO USE:  Take this medication by mouth with or without food||
8052|022|H|as directed by your doctor, usually 3 times a day. It may take||
8052|023|H|from several days to several months to complete treatment. Use||
8052|024|H|this medication regularly in order to get the most benefit from||
8052|025|H|it. Remember to use it at the same times each day. The dosage is||
8052|026|H|based on your medical condition and response to treatment.||
8052|027|H|   Continue to take this medication until the full prescribed||
8052|028|H|amount is finished, even if symptoms disappear after a few days.||
8052|029|H|Stopping the medication too early may allow the infection to||
8052|030|H|continue, resulting in a return of the infection.||
8052|031|H|   Tell your doctor if your condition lasts after several days of||
8052|032|H|treatment or gets worse at any time.||
8052|033|B|||
8052|034|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, or stomach upset may||
8052|035|S|occur. If any of these effects last or get worse, tell your||
8052|036|S|doctor or pharmacist promptly.||
8052|037|S|   Remember that this medication has been prescribed because your||
8052|038|S|doctor has judged that the benefit to you is greater than the||
8052|039|S|risk of side effects. Many people using this medication do not||
8052|040|S|have serious side effects.||
8052|041|S|   Tell your doctor right away if you have any serious side||
8052|042|S|effects, including fast heartbeat, shortness of breath, muscle||
8052|043|S|pain.||
8052|044|S|   A very serious allergic reaction to this drug is rare.||
8052|045|S|However, get medical help right away if you notice any symptoms||
8052|046|S|of a serious allergic reaction, including rash, itching/swelling||
8052|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8052|048|S|breathing.||
8052|049|S|   This is not a complete list of possible side effects. If you||
8052|050|S|notice other effects not listed above, contact your doctor or||
8052|051|S|pharmacist.||
8052|052|S|   In the US -||
8052|053|S|   Call your doctor for medical advice about side effects. You||
8052|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8052|055|S|www.fda.gov/medwatch.||
8052|056|S|   In Canada - Call your doctor for medical advice about side||
8052|057|S|effects. You may report side effects to Health Canada at||
8052|058|S|1-866-234-2345.||
8052|059|B|||
8052|060|P|PRECAUTIONS:  Before taking nystatin, tell your doctor or||
8052|061|P|pharmacist if you are allergic to it; or if you have any other||
8052|062|P|allergies. This product may contain inactive ingredients, which||
8052|063|P|can cause allergic reactions or other problems. Talk to your||
8052|064|P|pharmacist for more details.||
8052|065|P|   Before using this medication, tell your doctor or pharmacist||
8052|066|P|your medical history, especially of: HIV disease, diabetes,||
8052|067|P|kidney disease.||
8052|068|P|   Before having surgery, tell your doctor or dentist about all||
8052|069|P|the products you use (including prescription drugs,||
8052|070|P|nonprescription drugs, and herbal products).||
8052|071|P|   During pregnancy, this medication should be used only when||
8052|072|P|clearly needed. Discuss the risks and benefits with your doctor.||
8052|073|P|   It is unknown if this drug passes into breast milk. Consult||
8052|074|P|your doctor before breastfeeding.||
8052|075|B|||
8052|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8052|077|I|medications work or increase your risk for serious side effects.||
8052|078|I|This document does not contain all possible drug interactions.||
8052|079|I|Keep a list of all the products you use (including||
8052|080|I|prescription/nonprescription drugs and herbal products) and share||
8052|081|I|it with your doctor and pharmacist. Do not start, stop, or change||
8052|082|I|the dosage of any medicines without your doctor's approval.||
8052|083|B|||
8052|084|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8052|085|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8052|086|O|poison control center right away. US residents can call||
8052|087|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8052|088|B|||
8052|089|N|NOTES:  Do not share this medication with others.||
8052|090|N|   This medication has been prescribed for your current condition||
8052|091|N|only. Do not use it later for another infection unless your||
8052|092|N|doctor tells you to.||
8052|093|B|||
8052|094|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8052|095|D|remember. If it is near the time of the next dose, skip the||
8052|096|D|missed dose. Take your next dose at the regular time. Do not||
8052|097|D|double the dose to catch up.||
8052|098|B|||
8052|099|R|STORAGE:  Store at room temperature away from heat and moisture.||
8052|100|R|Do not store in the bathroom. Keep all medications away from||
8052|101|R|children and pets.||
8052|102|R|   Do not flush medications down the toilet or pour them into a||
8052|103|R|drain unless instructed to do so. Properly discard this product||
8052|104|R|when it is expired or no longer needed. Consult your pharmacist||
8052|105|R|or local waste disposal company.||
8052|106|B|||
8052|107|A|Information last revised May 2024.||
8052|108|A|Copyright(c) 2025 First Databank, Inc.||
8052|109|B|||
8053|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8053|002|Z|does NOT have all possible information about this product. This||
8053|003|Z|information does not assure that this product is safe, effective,||
8053|004|Z|or appropriate for you. This information is not individual||
8053|005|Z|medical advice and does not substitute for the advice of your||
8053|006|Z|health care professional. Always ask your health care||
8053|007|Z|professional for complete information about this product and your||
8053|008|Z|specific health needs.||
8053|009|B|||
8053|010|T|PROMETHAZINE - INJECTION||
8053|011|F|(pro-METH-uh-zeen)||
8053|012|B|||
8053|013|C|COMMON BRAND NAME(S): Phenergan||
8053|014|B|||
8053|015|W|WARNING:  Promethazine should not be used by children younger||
8053|016|W|than 2 years because it may cause serious (possibly fatal)||
8053|017|W|slow/shallow breathing. When this medication is used by children||
8053|018|W|2 years and older, use the lowest effective dosage and avoid||
8053|019|W|other drugs that affect breathing. Get medical help right away if||
8053|020|W|slow/shallow breathing occurs.||
8053|021|W|   In children, drugs for nausea should only be used in cases of||
8053|022|W|prolonged vomiting of a known cause. Avoid use of promethazine in||
8053|023|W|children with liver disease (including possible Reye's syndrome).||
8053|024|W|   This medication can cause severe tissue damage, possibly||
8053|025|W|requiring surgery. Tell your health care professional right away||
8053|026|W|if you have burning, pain, redness, swelling, or numbness at or||
8053|027|W|near the injection site. If this occurs, the injection should be||
8053|028|W|stopped and the injection site checked.||
8053|029|W|   It is preferred that this medication be given by injection||
8053|030|W|into a muscle. There may be an increased risk of side effects if||
8053|031|W|this medication is given by injection into a vein. This||
8053|032|W|medication must not be given by injection under the skin.||
8053|033|B|||
8053|034|U|USES:  Promethazine is used to prevent and treat nausea and||
8053|035|U|vomiting related to certain conditions (such as before/after||
8053|036|U|surgery, motion sickness). It is also used with other medication||
8053|037|U|to treat severe allergic reactions (anaphylaxis) and reactions to||
8053|038|U|blood products. It may also be used to treat milder allergic||
8053|039|U|reactions when you cannot take promethazine by mouth. It may also||
8053|040|U|be used to help you feel sleepy/relaxed before and after surgery,||
8053|041|U|during other procedures, or during labor and delivery. It may||
8053|042|U|also be used to help certain opioid pain relievers (such as||
8053|043|U|meperidine) work better.||
8053|044|U|   Promethazine is an antihistamine and works by blocking a||
8053|045|U|certain natural substance (histamine) that your body makes during||
8053|046|U|an allergic reaction. Its other effects (such as anti-nausea,||
8053|047|U|calming, pain relief) may work by affecting other natural||
8053|048|U|substances (such as acetylcholine) and by acting directly on||
8053|049|U|certain parts of the brain.||
8053|050|U|   This drug is not approved for use in children younger than 2||
8053|051|U|years due to an increased risk of side effects (such as||
8053|052|U|slow/shallow breathing). See also Warning section.||
8053|053|B|||
8053|054|H|HOW TO USE:  See also Warning section.||
8053|055|H|   This medication is given by injection into a muscle or a vein||
8053|056|H|by a health care professional. It should not be injected under||
8053|057|H|the skin or into an artery. For nausea and vomiting, this||
8053|058|H|medication is given as directed by your doctor, usually every 4||
8053|059|H|hours as needed.||
8053|060|H|   The dosage is based on your age, medical condition, and||
8053|061|H|response to treatment. Children's dosage may also be based on||
8053|062|H|weight.||
8053|063|H|   Tell your doctor if you do not get better or if you get worse.||
8053|064|B|||
8053|065|S|SIDE EFFECTS:  See also Warning section.||
8053|066|S|   Drowsiness, dizziness, constipation, blurred vision, or dry||
8053|067|S|mouth may occur. If any of these effects last or get worse, tell||
8053|068|S|your doctor or pharmacist promptly.||
8053|069|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
8053|070|S|chips, chew (sugarless) gum, drink water, or use a saliva||
8053|071|S|substitute.||
8053|072|S|   Remember that this medication has been prescribed because your||
8053|073|S|doctor has judged that the benefit to you is greater than the||
8053|074|S|risk of side effects. Many people using this medication do not||
8053|075|S|have serious side effects.||
8053|076|S|   Tell your doctor right away if you have any serious side||
8053|077|S|effects, including: signs of infection (such as sore throat that||
8053|078|S|doesn't go away, fever, chills), loss of coordination, fainting,||
8053|079|S|confusion, slow heartbeat, shaking (tremor), unusual/uncontrolled||
8053|080|S|movements (such as fixed upward stare, neck twisting, tongue||
8053|081|S|movements), mental/mood changes (such as hallucinations,||
8053|082|S|nervousness, irritability, restlessness, confusion), trouble||
8053|083|S|urinating, easy bleeding/bruising, severe stomach/abdominal pain,||
8053|084|S|yellowing of eyes/skin.||
8053|085|S|   Get medical help right away if you have any very serious side||
8053|086|S|effects, including: slow/shallow breathing, seizures.||
8053|087|S|   This medication may rarely cause a very serious condition||
8053|088|S|called neuroleptic malignant syndrome (NMS). Get medical help||
8053|089|S|right away if you have any of the following symptoms: fever,||
8053|090|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
8053|091|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
8053|092|S|signs of kidney problems (such as change in the amount of urine).||
8053|093|S|   A very serious allergic reaction to this drug is rare.||
8053|094|S|However, get medical help right away if you notice any symptoms||
8053|095|S|of a serious allergic reaction, including: rash, itching/swelling||
8053|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8053|097|S|breathing.||
8053|098|S|   This is not a complete list of possible side effects. If you||
8053|099|S|notice other effects not listed above, contact your doctor or||
8053|100|S|pharmacist.||
8053|101|S|   In the US -||
8053|102|S|   Call your doctor for medical advice about side effects. You||
8053|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8053|104|S|www.fda.gov/medwatch.||
8053|105|S|   In Canada - Call your doctor for medical advice about side||
8053|106|S|effects. You may report side effects to Health Canada at||
8053|107|S|1-866-234-2345.||
8053|108|B|||
8053|109|P|PRECAUTIONS:  See also Warning section.||
8053|110|P|   Before using promethazine, tell your doctor or pharmacist if||
8053|111|P|you are allergic to it; or to any other phenothiazines (such as||
8053|112|P|prochlorperazine); or if you have any other allergies. This||
8053|113|P|product may contain inactive ingredients (such as sulfites||
8053|114|P|including sodium metabisulfite), which can cause allergic||
8053|115|P|reactions or other problems. Talk to your pharmacist for more||
8053|116|P|details.||
8053|117|P|   Before using this medication, tell your doctor or pharmacist||
8053|118|P|your medical history, especially of: breathing problems (such as||
8053|119|P|asthma, chronic obstructive pulmonary disease-COPD, sleep apnea),||
8053|120|P|blood/immune system problems (such as bone marrow depression),||
8053|121|P|high pressure in the eye (glaucoma), heart disease (such as||
8053|122|P|angina, irregular heartbeat), high or low blood pressure, liver||
8053|123|P|disease, certain brain disorders (such as neuroleptic malignant||
8053|124|P|syndrome, Reye's syndrome, seizures), stomach/intestinal problems||
8053|125|P|(such as blockage, ulcer), trouble urinating (for example, due to||
8053|126|P|enlarged prostate).||
8053|127|P|   This drug may make you dizzy or drowsy or blur your vision.||
8053|128|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8053|129|P|drowsy. Do not drive, use machinery, or do anything that needs||
8053|130|P|alertness or clear vision until you can do it safely. Avoid||
8053|131|P|alcoholic beverages. Talk to your doctor if you are using||
8053|132|P|marijuana (cannabis). Children should be supervised during||
8053|133|P|bicycle riding and other possibly hazardous activities to avoid||
8053|134|P|injury.||
8053|135|P|   Before having surgery, tell your doctor or dentist about all||
8053|136|P|the products you use (including prescription drugs,||
8053|137|P|nonprescription drugs, and herbal products).||
8053|138|P|   This medication may make you more sensitive to the sun. Limit||
8053|139|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8053|140|P|sunscreen and wear protective clothing when outdoors. Tell your||
8053|141|P|doctor right away if you get sunburned or have skin||
8053|142|P|blisters/redness.||
8053|143|P|   This medication may make you sweat less, making you more||
8053|144|P|likely to get heat stroke. Avoid doing things that may cause you||
8053|145|P|to overheat, such as hard work or exercise in hot weather, or||
8053|146|P|using hot tubs. When the weather is hot, drink a lot of fluids||
8053|147|P|and dress lightly. If you overheat, quickly look for a place to||
8053|148|P|cool down and rest. Get medical help right away if you have a||
8053|149|P|fever that does not go away, mental/mood changes, headache, or||
8053|150|P|dizziness.||
8053|151|P|   Older adults may be more sensitive to the side effects of this||
8053|152|P|drug, especially drowsiness, confusion, constipation, or trouble||
8053|153|P|urinating. Drowsiness and confusion can increase the risk of||
8053|154|P|falling.||
8053|155|P|   Children may be more sensitive to the side effects of this||
8053|156|P|drug, especially slowed breathing and uncontrolled movements (see||
8053|157|P|also Warning section). This drug can often cause excitement in||
8053|158|P|young children instead of drowsiness. Special care should be||
8053|159|P|taken when using this medication in children who have lost a lot||
8053|160|P|of fluid (dehydration), those who have a family history of sudden||
8053|161|P|infant death syndrome (SIDS), and those who are hard to wake up||
8053|162|P|from sleep.||
8053|163|P|   During pregnancy, this medication should be used only when||
8053|164|P|clearly needed. Discuss the risks and benefits with your doctor.||
8053|165|P|   It is unknown if promethazine passes into breast milk. Consult||
8053|166|P|your doctor before breastfeeding.||
8053|167|B|||
8053|168|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8053|169|I|medications work or increase your risk for serious side effects.||
8053|170|I|This document does not contain all possible drug interactions.||
8053|171|I|Keep a list of all the products you use (including||
8053|172|I|prescription/nonprescription drugs and herbal products) and share||
8053|173|I|it with your doctor and pharmacist. Do not start, stop, or change||
8053|174|I|the dosage of any medicines without your doctor's approval.||
8053|175|I|   Some products that may interact with this drug include:||
8053|176|I|antihistamines applied to the skin (such as diphenhydramine||
8053|177|I|cream, ointment, spray), metoclopramide.||
8053|178|I|   The risk of serious side effects (such as slow/shallow||
8053|179|I|breathing, severe drowsiness/dizziness) may be increased if this||
8053|180|I|medication is used with other products that may also cause||
8053|181|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
8053|182|I|if you are taking other products such as opioid pain or cough||
8053|183|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8053|184|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
8053|185|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
8053|186|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
8053|187|I|diphenhydramine).||
8053|188|I|   Check the labels on all your medicines (such as allergy or||
8053|189|I|cough-and-cold products) because they may contain ingredients||
8053|190|I|that cause drowsiness. Ask your pharmacist about using those||
8053|191|I|products safely.||
8053|192|I|   This medication may interfere with certain lab tests (such as||
8053|193|I|some pregnancy tests, blood sugar tests), possibly causing false||
8053|194|I|test results. Make sure lab personnel and all your doctors know||
8053|195|I|you use this drug.||
8053|196|B|||
8053|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8053|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8053|199|O|poison control center right away. US residents can call||
8053|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8053|201|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
8053|202|O|fainting, slow/shallow breathing, seizures, muscle||
8053|203|O|stiffness/twitching, widened pupils. In children, mental/mood||
8053|204|O|changes (such as restlessness, irritability, hallucinations) may||
8053|205|O|occur before drowsiness.||
8053|206|B|||
8053|207|N|NOTES:  Do not share this medication with others.||
8053|208|B|||
8053|209|D|MISSED DOSE:  If you are using this medication on a regular||
8053|210|D|schedule and you miss a dose, use it as soon as you remember. If||
8053|211|D|it is near the time of the next dose, skip the missed dose. Use||
8053|212|D|your next dose at the regular time. Do not double the dose to||
8053|213|D|catch up.||
8053|214|B|||
8053|215|R|STORAGE:  Store at room temperature away from light. Keep all||
8053|216|R|medications away from children and pets.||
8053|217|R|   Do not flush medications down the toilet or pour them into a||
8053|218|R|drain unless instructed to do so. Properly discard this product||
8053|219|R|when it is expired or no longer needed. Consult your pharmacist||
8053|220|R|or local waste disposal company.||
8053|221|B|||
8053|222|A|Information last revised January 2025.||
8053|223|A|Copyright(c) 2025 First Databank, Inc.||
8053|224|B|||
8055|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8055|002|Z|does NOT have all possible information about this product. This||
8055|003|Z|information does not assure that this product is safe, effective,||
8055|004|Z|or appropriate for you. This information is not individual||
8055|005|Z|medical advice and does not substitute for the advice of your||
8055|006|Z|health care professional. Always ask your health care||
8055|007|Z|professional for complete information about this product and your||
8055|008|Z|specific health needs.||
8055|009|B|||
8055|010|T|METRONIDAZOLE - TOPICAL||
8055|011|F|(MET-roe-NYE-da-zole)||
8055|012|B|||
8055|013|C|COMMON BRAND NAME(S): Metrocream, Metrogel, Metrolotion, Noritate||
8055|014|B|||
8055|015|U|USES:  This medication is used on the skin to treat a certain||
8055|016|U|skin disorder known as rosacea, a type of adult acne. It may help||
8055|017|U|to decrease redness, swelling and the number of pimples caused by||
8055|018|U|rosacea.||
8055|019|U|   This medication is an antibiotic. For the treatment of||
8055|020|U|rosacea, metronidazole is believed to work by decreasing swelling||
8055|021|U|(inflammation). Some brands of this medication also contain||
8055|022|U|sunscreens (see also Notes section).||
8055|023|B|||
8055|024|H|HOW TO USE:  Use this medication on the skin only. Wash and dry||
8055|025|H|your hands before and after applying this medication. Wash and||
8055|026|H|dry the area to be treated. Wait 15 minutes, then apply a thin||
8055|027|H|layer of medication as directed by your doctor, usually once or||
8055|028|H|twice daily. Wait 5 minutes before applying cosmetics.||
8055|029|H|   Avoid using this medication around the eye area, unless||
8055|030|H|directed by your doctor. Watery eyes or tearing of the eyes may||
8055|031|H|occur if this medication is applied too close to the eyes. Avoid||
8055|032|H|getting this medication in your eyes. If this occurs, rinse your||
8055|033|H|eyes with large amounts of cool water.||
8055|034|H|   Use this medication regularly in order to get the most benefit||
8055|035|H|from it. Remember to use it at the same times each day.||
8055|036|H|   It may take about three weeks before your condition gets||
8055|037|H|better, and up to nine weeks for the full benefit of this||
8055|038|H|medication. Tell your doctor if your condition does not get||
8055|039|H|better or if it gets worse.||
8055|040|B|||
8055|041|S|SIDE EFFECTS:  Stinging, burning, skin irritation, dryness,||
8055|042|S|redness, metallic taste, nausea, or headache may occur. If any of||
8055|043|S|these effects last or get worse, tell your doctor or pharmacist||
8055|044|S|promptly.||
8055|045|S|   Remember that this medication has been prescribed because your||
8055|046|S|doctor has judged that the benefit to you is greater than the||
8055|047|S|risk of side effects. Many people using this medication do not||
8055|048|S|have serious side effects.||
8055|049|S|   Tell your doctor right away if you have any serious side||
8055|050|S|effects, including: tingling or numbness of the hands and feet.||
8055|051|S|   A very serious allergic reaction to this drug is rare.||
8055|052|S|However, get medical help right away if you notice any symptoms||
8055|053|S|of a serious allergic reaction, including: fever, swollen lymph||
8055|054|S|nodes, rash, itching/swelling (especially of the||
8055|055|S|face/tongue/throat), severe dizziness, trouble breathing.||
8055|056|S|   This is not a complete list of possible side effects. If you||
8055|057|S|notice other effects not listed above, contact your doctor or||
8055|058|S|pharmacist.||
8055|059|S|   In the US -||
8055|060|S|   Call your doctor for medical advice about side effects. You||
8055|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8055|062|S|www.fda.gov/medwatch.||
8055|063|S|   In Canada - Call your doctor for medical advice about side||
8055|064|S|effects. You may report side effects to Health Canada at||
8055|065|S|1-866-234-2345.||
8055|066|B|||
8055|067|P|PRECAUTIONS:  Before using metronidazole, tell your doctor or||
8055|068|P|pharmacist if you are allergic to it; or to other nitroimidazole||
8055|069|P|antibiotics (such as tinidazole); or to other ingredients in this||
8055|070|P|product; or if you have any other allergies. This product may||
8055|071|P|contain inactive ingredients, which can cause allergic reactions||
8055|072|P|or other problems. Talk to your pharmacist for more details.||
8055|073|P|   Before using this medication, tell your doctor or pharmacist||
8055|074|P|your medical history, especially of: blood disorders (blood||
8055|075|P|dyscrasias).||
8055|076|P|   Before having surgery, tell your doctor or dentist about all||
8055|077|P|the products you use (including prescription drugs,||
8055|078|P|nonprescription drugs, and herbal products).||
8055|079|P|   During pregnancy, this medication should be used only when||
8055|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
8055|081|P|   It is unknown if this medication passes into breast milk.||
8055|082|P|Consult your doctor before breastfeeding.||
8055|083|B|||
8055|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8055|085|I|medications work or increase your risk for serious side effects.||
8055|086|I|This document does not contain all possible drug interactions.||
8055|087|I|Keep a list of all the products you use (including||
8055|088|I|prescription/nonprescription drugs and herbal products) and share||
8055|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
8055|090|I|the dosage of any medicines without your doctor's approval.||
8055|091|B|||
8055|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8055|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8055|094|O|poison control center right away. US residents can call||
8055|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
8055|096|O|medicine may be harmful if swallowed.||
8055|097|B|||
8055|098|N|NOTES:  Do not share this medication with others.||
8055|099|N|   This medication has been prescribed for your current condition||
8055|100|N|only. Do not use it later for another condition unless told to do||
8055|101|N|so by your doctor. A different medication may be necessary in||
8055|102|N|those cases.||
8055|103|N|   Sun exposure can worsen rosacea. Limit exposure to the sun by||
8055|104|N|wearing a wide-brimmed hat and using a sunscreen that is SPF 15||
8055|105|N|or greater. If your brand already contains a sunscreen, you||
8055|106|N|should use a regular sunscreen (without the metronidazole) on||
8055|107|N|areas of skin not treated with this medication.||
8055|108|N|   Avoid certain triggers that may worsen rosacea such as wind,||
8055|109|N|hot beverages, spicy foods, alcohol, and extreme cold. Discuss||
8055|110|N|with your doctor.||
8055|111|B|||
8055|112|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8055|113|D|If it is near the time of the next dose, skip the missed dose.||
8055|114|D|Use your next dose at the regular time. Do not double the dose to||
8055|115|D|catch up.||
8055|116|B|||
8055|117|R|STORAGE:  Store at room temperature. Keep all medications away||
8055|118|R|from children and pets.||
8055|119|R|   Do not flush medications down the toilet or pour them into a||
8055|120|R|drain unless instructed to do so. Properly discard this product||
8055|121|R|when it is expired or no longer needed. Consult your pharmacist||
8055|122|R|or local waste disposal company.||
8055|123|B|||
8055|124|A|Information last revised July 2024.||
8055|125|A|Copyright(c) 2025 First Databank, Inc.||
8055|126|B|||
8058|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8058|002|Z|does NOT have all possible information about this product. This||
8058|003|Z|information does not assure that this product is safe, effective,||
8058|004|Z|or appropriate for you. This information is not individual||
8058|005|Z|medical advice and does not substitute for the advice of your||
8058|006|Z|health care professional. Always ask your health care||
8058|007|Z|professional for complete information about this product and your||
8058|008|Z|specific health needs.||
8058|009|B|||
8058|010|T|POTASSIUM EFFERVESCENT TABLET- ORAL||
8058|011|F|(poe-TAS-ee-um)||
8058|012|B|||
8058|013|C|COMMON BRAND NAME(S): Effer-K, K-Lyte||
8058|014|B|||
8058|015|U|USES:  This medication is a mineral supplement used to treat or||
8058|016|U|prevent low amounts of potassium in the blood. A normal level of||
8058|017|U|potassium in the blood is important. Potassium helps your cells,||
8058|018|U|kidneys, heart, muscles, and nerves work properly. Most people||
8058|019|U|get enough potassium by eating a well-balanced diet. Some||
8058|020|U|conditions that can lower your body's potassium level include||
8058|021|U|severe prolonged diarrhea and vomiting, hormone problems such as||
8058|022|U|hyperaldosteronism, or treatment with "water pills"/diuretics.||
8058|023|B|||
8058|024|H|HOW TO USE:  Take this medication by mouth as directed by your||
8058|025|H|doctor, usually 1 to 4 times daily. To prevent stomach upset,||
8058|026|H|take each dose with a meal. Dissolve the prescribed number of||
8058|027|H|tablets in at least 4 ounces (120 milliliters) of cold water or||
8058|028|H|juice per tablet. After the tablets are fully dissolved, sip the||
8058|029|H|liquid slowly over 5 to 10 minutes. If you have upset stomach,||
8058|030|H|mixing your dose in a larger amount of liquid may help.||
8058|031|H|   Take this medication regularly to get the most benefit from||
8058|032|H|it. To help you remember, take it at the same time(s) each day.||
8058|033|H|The dosage is based on your medical condition and response to||
8058|034|H|treatment. Do not increase your dose or take it more often than||
8058|035|H|prescribed.||
8058|036|H|   Tell your doctor if your condition does not get better or if||
8058|037|H|you have symptoms of low potassium in the blood (such as||
8058|038|H|irregular heartbeat, muscle weakness/cramps).||
8058|039|B|||
8058|040|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, gas, or diarrhea||
8058|041|S|may occur. If any of these effects last or get worse, tell your||
8058|042|S|doctor or pharmacist promptly.||
8058|043|S|   Remember that this medication has been prescribed because your||
8058|044|S|doctor has judged that the benefit to you is greater than the||
8058|045|S|risk of side effects. Many people using this medication do not||
8058|046|S|have serious side effects.||
8058|047|S|   Get medical help right away if you have any very serious side||
8058|048|S|effects, including: vomit that looks like coffee grounds,||
8058|049|S|stomach/abdominal pain, black/tarry stools.||
8058|050|S|   A very serious allergic reaction to this drug is rare.||
8058|051|S|However, get medical help right away if you notice any symptoms||
8058|052|S|of a serious allergic reaction, including: rash, itching/swelling||
8058|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8058|054|S|breathing.||
8058|055|S|   This is not a complete list of possible side effects. If you||
8058|056|S|notice other effects not listed above, contact your doctor or||
8058|057|S|pharmacist.||
8058|058|S|   In the US -||
8058|059|S|   Call your doctor for medical advice about side effects. You||
8058|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8058|061|S|www.fda.gov/medwatch.||
8058|062|S|   In Canada - Call your doctor for medical advice about side||
8058|063|S|effects. You may report side effects to Health Canada at||
8058|064|S|1-866-234-2345.||
8058|065|B|||
8058|066|P|PRECAUTIONS:  Before taking potassium, tell your doctor or||
8058|067|P|pharmacist if you have any allergies. This product may contain||
8058|068|P|inactive ingredients, which can cause allergic reactions or other||
8058|069|P|problems. Talk to your pharmacist for more details.||
8058|070|P|   Before using this medication, tell your doctor or pharmacist||
8058|071|P|your medical history, especially of: heart problems, kidney||
8058|072|P|problems, high levels of potassium in the blood,||
8058|073|P|throat/stomach/intestinal problems (such as blockage, narrowing,||
8058|074|P|ulcers).||
8058|075|P|   Before having surgery, tell your doctor or dentist about all||
8058|076|P|the products you use (including prescription drugs,||
8058|077|P|nonprescription drugs, and herbal products).||
8058|078|P|   Before using other potassium supplements or salt substitutes||
8058|079|P|that contain potassium, consult your doctor or pharmacist. Too||
8058|080|P|much potassium may cause serious side effects. (See also Overdose||
8058|081|P|section.)||
8058|082|P|   During pregnancy, this medication should be used only when||
8058|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
8058|084|P|   Potassium passes into breast milk. Consult your doctor before||
8058|085|P|breastfeeding.||
8058|086|B|||
8058|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8058|088|I|medications work or increase your risk for serious side effects.||
8058|089|I|This document does not contain all possible drug interactions.||
8058|090|I|Keep a list of all the products you use (including||
8058|091|I|prescription/nonprescription drugs and herbal products) and share||
8058|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
8058|093|I|the dosage of any medicines without your doctor's approval.||
8058|094|I|   Tell your doctor or pharmacist if you are regularly taking||
8058|095|I|other medications that can also raise your potassium level.||
8058|096|I|Examples include drospirenone, eplerenone, ACE inhibitors (such||
8058|097|I|as enalapril, lisinopril), angiotensin receptor blockers (such as||
8058|098|I|losartan, valsartan), potassium-sparing "water pills"/diuretics||
8058|099|I|(such as spironolactone, triamterene), among others.||
8058|100|B|||
8058|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8058|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8058|103|O|poison control center right away. US residents can call||
8058|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8058|105|O|Symptoms of overdose may include irregular heartbeat, muscle||
8058|106|O|weakness, confusion.||
8058|107|B|||
8058|108|N|NOTES:  Do not share this medication with others.||
8058|109|N|   Lab and/or medical tests (such as potassium blood level,||
8058|110|N|kidney function) should be done while you are taking this||
8058|111|N|medication. Keep all medical and lab appointments. Consult your||
8058|112|N|doctor for more details.||
8058|113|N|   Eat a well-balanced diet. Foods high in potassium include||
8058|114|N|bananas, oranges, cantaloupe, raisins, dates, prunes, avocados,||
8058|115|N|apricots, beans, broccoli, spinach, potatoes, lentils, chicken,||
8058|116|N|turkey, beef, and yogurt. Consult your doctor or dietician for||
8058|117|N|recommended foods.||
8058|118|B|||
8058|119|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8058|120|D|remember. If it is near the time of the next dose, skip the||
8058|121|D|missed dose. Take your next dose at the regular time. Do not||
8058|122|D|double the dose to catch up.||
8058|123|B|||
8058|124|R|STORAGE:  Store at room temperature away from light and moisture.||
8058|125|R|Do not store in the bathroom. Keep all medications away from||
8058|126|R|children and pets.||
8058|127|R|   Do not flush medications down the toilet or pour them into a||
8058|128|R|drain unless instructed to do so. Properly discard this product||
8058|129|R|when it is expired or no longer needed. Consult your pharmacist||
8058|130|R|or local waste disposal company.||
8058|131|B|||
8058|132|A|Information last revised November 2024.||
8058|133|A|Copyright(c) 2025 First Databank, Inc.||
8058|134|B|||
8059|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8059|002|Z|does NOT have all possible information about this product. This||
8059|003|Z|information does not assure that this product is safe, effective,||
8059|004|Z|or appropriate for you. This information is not individual||
8059|005|Z|medical advice and does not substitute for the advice of your||
8059|006|Z|health care professional. Always ask your health care||
8059|007|Z|professional for complete information about this product and your||
8059|008|Z|specific health needs.||
8059|009|B|||
8059|010|T|NITROFURANTOIN/NITROFURANTOIN MACROCRYSTALS - ORAL||
8059|011|F|(NYE-trow-fyour-AN-toe-in)||
8059|012|B|||
8059|013|C|COMMON BRAND NAME(S): Macrobid||
8059|014|B|||
8059|015|U|USES:  This medication is an antibiotic used to treat bladder||
8059|016|U|infections (acute cystitis). It works by stopping the growth of||
8059|017|U|bacteria.||
8059|018|U|   This antibiotic treats only bacterial infections. It will not||
8059|019|U|work for viral infections (such as common cold, flu). Using any||
8059|020|U|antibiotic when it is not needed can cause it to not work for||
8059|021|U|future infections.||
8059|022|U|   This medication should not be used in infants younger than 1||
8059|023|U|month old (see also Precautions section). This drug should not be||
8059|024|U|used to treat infections outside the bladder (including kidney||
8059|025|U|infections such as pyelonephritis or perinephric abscesses).||
8059|026|B|||
8059|027|H|HOW TO USE:  Take this medication by mouth with food as directed||
8059|028|H|by your doctor, usually twice daily (every 12 hours). Swallow the||
8059|029|H|medication whole for best results.||
8059|030|H|   Do not use magnesium trisilicate-containing antacids while||
8059|031|H|taking this medication. These antacids can bind with||
8059|032|H|nitrofurantoin, preventing its full absorption into your system.||
8059|033|H|   For the best effect, take this antibiotic at evenly spaced||
8059|034|H|times. To help you remember, take this medication at the same||
8059|035|H|time(s) every day.||
8059|036|H|   Continue to take this medication until the full prescribed||
8059|037|H|amount is finished, even if symptoms disappear after a few days.||
8059|038|H|Stopping the medication too early may result in a return of the||
8059|039|H|infection.||
8059|040|H|   Tell your doctor if your condition lasts or gets worse.||
8059|041|B|||
8059|042|S|SIDE EFFECTS:  Nausea, headache, or diarrhea may occur. If any of||
8059|043|S|these effects last or get worse, tell your doctor or pharmacist||
8059|044|S|promptly.||
8059|045|S|   Remember that this medication has been prescribed because your||
8059|046|S|doctor has judged that the benefit to you is greater than the||
8059|047|S|risk of side effects. Many people using this medication do not||
8059|048|S|have serious side effects.||
8059|049|S|   This medication may cause your urine to turn dark yellow or||
8059|050|S|brown in color. This is usually a harmless, temporary effect and||
8059|051|S|will disappear when the medication is stopped. However, dark||
8059|052|S|brown urine can also be a sign of rare side effects (liver||
8059|053|S|problems or anemia). Get medical help right away if you notice||
8059|054|S|dark urine along with any of the following symptoms:||
8059|055|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
8059|056|S|yellowing eyes/skin, tiredness, fast/pounding heartbeat.||
8059|057|S|   Tell your doctor right away if you have any serious side||
8059|058|S|effects, including: headaches that are severe or don't go away,||
8059|059|S|eye pain, vision changes, mental/mood changes, new signs of||
8059|060|S|infection (such as sore throat that doesn't go away, fever,||
8059|061|S|chills), easy bruising/bleeding.||
8059|062|S|   Get medical help right away if you have any very serious side||
8059|063|S|effects, including: numbness/tingling of the hands/feet, unusual||
8059|064|S|muscle weakness.||
8059|065|S|   This medication may rarely cause very serious (possibly fatal)||
8059|066|S|lung problems. Lung problems may occur within the first month of||
8059|067|S|treatment or after long-term use of nitrofurantoin (generally for||
8059|068|S|6 months or longer). Get medical help right away if you develop||
8059|069|S|symptoms of lung problems, including: cough that doesn't go away,||
8059|070|S|chest pain, shortness of breath/trouble breathing, joint/muscle||
8059|071|S|pain, bluish/purplish skin.||
8059|072|S|   This medication may rarely cause a severe intestinal condition||
8059|073|S|due to a bacteria called C. difficile. This condition may occur||
8059|074|S|during treatment or weeks to months after treatment has stopped.||
8059|075|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8059|076|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8059|077|S|stool.||
8059|078|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8059|079|S|products because they may make symptoms worse.||
8059|080|S|   Use of nitrofurantoin for prolonged or repeated periods may||
8059|081|S|result in oral thrush or a new vaginal yeast infection. Contact||
8059|082|S|your doctor if you notice white patches in your mouth, a change||
8059|083|S|in vaginal discharge, or other new symptoms.||
8059|084|S|   A very serious allergic reaction to this drug is rare.||
8059|085|S|However, get medical help right away if you notice any symptoms||
8059|086|S|of a serious allergic reaction, including: rash, itching/swelling||
8059|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8059|088|S|breathing.||
8059|089|S|   This is not a complete list of possible side effects. If you||
8059|090|S|notice other effects not listed above, contact your doctor or||
8059|091|S|pharmacist.||
8059|092|S|   In the US -||
8059|093|S|   Call your doctor for medical advice about side effects. You||
8059|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8059|095|S|www.fda.gov/medwatch.||
8059|096|S|   In Canada - Call your doctor for medical advice about side||
8059|097|S|effects. You may report side effects to Health Canada at||
8059|098|S|1-866-234-2345.||
8059|099|B|||
8059|100|P|PRECAUTIONS:  Before taking nitrofurantoin, tell your doctor or||
8059|101|P|pharmacist if you are allergic to it; or if you have any other||
8059|102|P|allergies. This product may contain inactive ingredients, which||
8059|103|P|can cause allergic reactions or other problems. Talk to your||
8059|104|P|pharmacist for more details.||
8059|105|P|   Before using this medication, tell your doctor or pharmacist||
8059|106|P|your medical history, especially of: kidney disease, liver||
8059|107|P|disease (including liver problems caused by nitrofurantoin in the||
8059|108|P|past), a certain genetic condition (G-6-PD deficiency), lung||
8059|109|P|disease, numbness/tingling of the arms/legs, vitamin B||
8059|110|P|deficiency, mineral imbalance, blood disorders (such as anemia),||
8059|111|P|diabetes, ongoing weakness due to long-term disease, certain eye||
8059|112|P|disorders (such as optic neuritis).||
8059|113|P|   Older adults may be at a greater risk for side effects while||
8059|114|P|using this drug, especially nerve, liver or lung problems.||
8059|115|P|   This medication may cause live bacterial vaccines (such as||
8059|116|P|typhoid vaccine) to not work well. Tell your health care||
8059|117|P|professional that you are using this medication before having any||
8059|118|P|immunizations/vaccinations.||
8059|119|P|   During pregnancy, this medication should be used only when||
8059|120|P|clearly needed. It must not be used if you are near the end of||
8059|121|P|your pregnancy (38-42 weeks), or at the time of labor and||
8059|122|P|delivery. Doing so may cause a certain blood disorder (hemolytic||
8059|123|P|anemia) in your baby. Discuss the risks and benefits with your||
8059|124|P|doctor.||
8059|125|P|   This medication passes into breast milk and may have||
8059|126|P|undesirable effects on nursing infants younger than 1 month old||
8059|127|P|or those with a certain genetic condition (G-6-PD deficiency).||
8059|128|P|Consult your doctor before breastfeeding.||
8059|129|B|||
8059|130|I|DRUG INTERACTIONS:  See also How to Use section.||
8059|131|I|   Drug interactions may change how your medications work or||
8059|132|I|increase your risk for serious side effects. This document does||
8059|133|I|not contain all possible drug interactions. Keep a list of all||
8059|134|I|the products you use (including prescription/nonprescription||
8059|135|I|drugs and herbal products) and share it with your doctor and||
8059|136|I|pharmacist. Do not start, stop, or change the dosage of any||
8059|137|I|medicines without your doctor's approval.||
8059|138|I|   This medication may interfere with certain lab tests (such as||
8059|139|I|certain urine glucose tests), possibly causing false test||
8059|140|I|results. Make sure lab personnel and all your doctors know you||
8059|141|I|use this drug.||
8059|142|B|||
8059|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8059|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8059|145|O|poison control center right away. US residents can call||
8059|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8059|147|B|||
8059|148|N|NOTES:  Do not share this medication with others.||
8059|149|N|   This medication has been prescribed for your current condition||
8059|150|N|only. Do not use it later for another infection unless your||
8059|151|N|doctor tells you to.||
8059|152|N|   Lab and/or medical tests (such as kidney/liver function,||
8059|153|N|complete blood count, bacterial culture) should be done while you||
8059|154|N|are taking this medication. Lung function tests should be done if||
8059|155|N|you are prescribed nitrofurantoin products for extended treatment||
8059|156|N|(several months or more). Keep all medical and lab appointments.||
8059|157|N|Consult your doctor for more details.||
8059|158|B|||
8059|159|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8059|160|D|remember. If it is near the time of the next dose, skip the||
8059|161|D|missed dose. Take your next dose at the regular time. Do not||
8059|162|D|double the dose to catch up.||
8059|163|B|||
8059|164|R|STORAGE:  Store at room temperature away from light and moisture.||
8059|165|R|Do not store in the bathroom. Keep all medications away from||
8059|166|R|children and pets.||
8059|167|R|   Do not flush medications down the toilet or pour them into a||
8059|168|R|drain unless instructed to do so. Properly discard this product||
8059|169|R|when it is expired or no longer needed. Consult your pharmacist||
8059|170|R|or local waste disposal company.||
8059|171|B|||
8059|172|A|Information last revised May 2025.||
8059|173|A|Copyright(c) 2025 First Databank, Inc.||
8059|174|B|||
8060|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8060|002|Z|does NOT have all possible information about this product. This||
8060|003|Z|information does not assure that this product is safe, effective,||
8060|004|Z|or appropriate for you. This information is not individual||
8060|005|Z|medical advice and does not substitute for the advice of your||
8060|006|Z|health care professional. Always ask your health care||
8060|007|Z|professional for complete information about this product and your||
8060|008|Z|specific health needs.||
8060|009|B|||
8060|010|T|DOXAZOSIN - ORAL||
8060|011|F|(dox-AZE-oh-sin)||
8060|012|B|||
8060|013|C|COMMON BRAND NAME(S): Cardura||
8060|014|B|||
8060|015|U|USES:  Doxazosin is used alone or with other drugs to treat high||
8060|016|U|blood pressure (hypertension). Lowering high blood pressure helps||
8060|017|U|prevent strokes, heart attacks, and kidney problems. This||
8060|018|U|medication works by relaxing blood vessels so blood can flow more||
8060|019|U|easily.||
8060|020|U|   Doxazosin is also used in men to treat the symptoms of an||
8060|021|U|enlarged prostate (benign prostatic hyperplasia-BPH). It does not||
8060|022|U|shrink the prostate, but it works by relaxing the muscles in the||
8060|023|U|prostate and part of the bladder. This helps to relieve symptoms||
8060|024|U|of BPH such as difficulty in beginning the flow of urine, weak||
8060|025|U|stream, and the need to urinate often or urgently (including||
8060|026|U|during the middle of the night).||
8060|027|U|   Doxazosin belongs to a class of drugs known as alpha blockers.||
8060|028|B|||
8060|029|V|OTHER USES:  This section contains uses of this drug that are not||
8060|030|V|listed in the approved professional labeling for the drug but||
8060|031|V|that may be prescribed by your health care professional. Use this||
8060|032|V|drug for a condition that is listed in this section only if it||
8060|033|V|has been so prescribed by your health care professional.||
8060|034|V|   This drug may also be used to help your body "pass," or get||
8060|035|V|rid of, kidney stones through urination. It may also be used for||
8060|036|V|bladder problems in women.||
8060|037|B|||
8060|038|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8060|039|H|from your pharmacist before you start taking doxazosin and each||
8060|040|H|time you get a refill. If you have any questions, ask your doctor||
8060|041|H|or pharmacist.||
8060|042|H|   Take this medication by mouth with or without food as directed||
8060|043|H|by your doctor, usually once daily.||
8060|044|H|   Doxazosin may cause a sudden drop in your blood pressure,||
8060|045|H|which could lead to dizziness or fainting, usually within 2 to 6||
8060|046|H|hours after you take it. This risk is higher when you first start||
8060|047|H|taking this drug, after your doctor increases your dose, or if||
8060|048|H|you restart treatment after you stop taking it. During these||
8060|049|H|times, avoid situations where you may be injured if you faint.||
8060|050|H|   To avoid injury related to dizziness or fainting, take your||
8060|051|H|first dose of doxazosin at bedtime unless otherwise directed by||
8060|052|H|your doctor. Your doctor will start this medication at a low dose||
8060|053|H|and gradually increase your dose. Any time your dose is increased||
8060|054|H|or if you restart treatment after you have stopped it, take your||
8060|055|H|first dose at bedtime unless otherwise directed. Follow your||
8060|056|H|doctor's instructions carefully.||
8060|057|H|   The dosage is based on your medical condition and response to||
8060|058|H|treatment.||
8060|059|H|   Take this medication regularly to get the most benefit from||
8060|060|H|it. To help you remember, take it at the same time each day. If||
8060|061|H|you miss taking doxazosin for a few days, you may need to restart||
8060|062|H|treatment at the low dose and gradually increase your dose again.||
8060|063|H|Consult your doctor for more details.||
8060|064|H|   Keep taking this medication even if you feel well. Most people||
8060|065|H|with high blood pressure do not feel sick.||
8060|066|H|   You should see a benefit from this drug within 1 to 2 weeks.||
8060|067|H|Tell your doctor if your condition does not get better or if it||
8060|068|H|gets worse (for example, your blood pressure readings remain high||
8060|069|H|or increase, your BPH symptoms worsen).||
8060|070|B|||
8060|071|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, unusual||
8060|072|S|tiredness, or weight gain may occur. If any of these effects last||
8060|073|S|or get worse, tell your doctor or pharmacist promptly.||
8060|074|S|   To reduce the risk of dizziness and lightheadedness, get up||
8060|075|S|slowly when rising from a sitting or lying position.||
8060|076|S|   Remember that this medication has been prescribed because your||
8060|077|S|doctor has judged that the benefit to you is greater than the||
8060|078|S|risk of side effects. Many people using this medication do not||
8060|079|S|have serious side effects.||
8060|080|S|   Tell your doctor right away if you have any serious side||
8060|081|S|effects, including: signs of infection (such as sore throat that||
8060|082|S|doesn't go away, fever, chills), fainting, shortness of breath,||
8060|083|S|weakness, swelling of hands/feet.||
8060|084|S|   Get medical help right away if you have any very serious side||
8060|085|S|effects, including: chest pain.||
8060|086|S|   Rarely, males may have a painful or prolonged erection lasting||
8060|087|S|4 or more hours. If this occurs, stop using this drug and get||
8060|088|S|medical help right away, or permanent problems could occur.||
8060|089|S|   A very serious allergic reaction to this drug is rare.||
8060|090|S|However, get medical help right away if you notice any symptoms||
8060|091|S|of a serious allergic reaction, including: rash, itching/swelling||
8060|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8060|093|S|breathing.||
8060|094|S|   This is not a complete list of possible side effects. If you||
8060|095|S|notice other effects not listed above, contact your doctor or||
8060|096|S|pharmacist.||
8060|097|S|   In the US -||
8060|098|S|   Call your doctor for medical advice about side effects. You||
8060|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8060|100|S|www.fda.gov/medwatch.||
8060|101|S|   In Canada - Call your doctor for medical advice about side||
8060|102|S|effects. You may report side effects to Health Canada at||
8060|103|S|1-866-234-2345.||
8060|104|B|||
8060|105|P|PRECAUTIONS:  Before taking doxazosin, tell your doctor or||
8060|106|P|pharmacist if you are allergic to it; or to other alpha blockers||
8060|107|P|such as prazosin or terazosin; or if you have any other||
8060|108|P|allergies. This product may contain inactive ingredients, which||
8060|109|P|can cause allergic reactions or other problems. Talk to your||
8060|110|P|pharmacist for more details.||
8060|111|P|   Before using this medication, tell your doctor or pharmacist||
8060|112|P|your medical history, especially of: heart disease (such as heart||
8060|113|P|failure, angina, heart attack in last 6 months), liver disease,||
8060|114|P|certain eye problems (cataracts, glaucoma).||
8060|115|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8060|116|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8060|117|P|machinery, or do anything that needs alertness until you can do||
8060|118|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8060|119|P|are using marijuana (cannabis). See also How to Use section.||
8060|120|P|   Before having surgery (including cataract/glaucoma eye||
8060|121|P|surgery), tell your doctor or dentist if you are taking or have||
8060|122|P|ever taken this medication, and about all the other products you||
8060|123|P|use (including prescription drugs, nonprescription drugs, and||
8060|124|P|herbal products).||
8060|125|P|   Older adults may be more sensitive to the side effects of this||
8060|126|P|drug, especially dizziness and low blood pressure when getting up||
8060|127|P|from a sitting or lying position. These side effects can increase||
8060|128|P|the risk of falling.||
8060|129|P|   During pregnancy, this medication should be used only when||
8060|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
8060|131|P|   This drug passes into breast milk. Consult your doctor before||
8060|132|P|breastfeeding.||
8060|133|B|||
8060|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8060|135|I|medications work or increase your risk for serious side effects.||
8060|136|I|This document does not contain all possible drug interactions.||
8060|137|I|Keep a list of all the products you use (including||
8060|138|I|prescription/nonprescription drugs and herbal products) and share||
8060|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
8060|140|I|the dosage of any medicines without your doctor's approval.||
8060|141|I|   Some products that may interact with this drug include: other||
8060|142|I|alpha blocker drugs (such as prazosin, tamsulosin).||
8060|143|I|   If you are also taking a drug to treat erectile dysfunction-ED||
8060|144|I|or pulmonary hypertension (such as sildenafil, tadalafil), your||
8060|145|I|blood pressure may get too low which can lead to dizziness or||
8060|146|I|fainting. Your doctor may need to adjust your medications to||
8060|147|I|minimize this risk.||
8060|148|I|   Other medications can affect the removal of doxazosin from||
8060|149|I|your body, which may affect how doxazosin works. Examples include||
8060|150|I|azole antifungals (such as itraconazole, ketoconazole), macrolide||
8060|151|I|antibiotics (such as clarithromycin), HIV protease inhibitors||
8060|152|I|(such as lopinavir), ritonavir, among others.||
8060|153|I|   Some products have ingredients that could raise your blood||
8060|154|I|pressure. Tell your pharmacist what products you are using, and||
8060|155|I|ask how to use them safely (especially cough-and-cold products,||
8060|156|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
8060|157|B|||
8060|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8060|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8060|160|O|poison control center right away. US residents can call||
8060|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8060|162|O|Symptoms of overdose may include: severe dizziness, fainting,||
8060|163|O|weakness.||
8060|164|B|||
8060|165|N|NOTES:  Do not share this medication with others.||
8060|166|N|   If you have high blood pressure, lifestyle changes that may||
8060|167|N|help this medication work better include exercising, stopping||
8060|168|N|smoking, and eating a low-cholesterol/low-fat diet. Consult your||
8060|169|N|doctor for more details.||
8060|170|N|   Have your blood pressure checked regularly while taking this||
8060|171|N|medication. Learn how to monitor your own blood pressure at home,||
8060|172|N|and share the results with your doctor.||
8060|173|N|   Lab and/or medical tests (such as prostate exams, blood||
8060|174|N|pressure) should be done while you are taking this medication.||
8060|175|N|Keep all medical and lab appointments. Consult your doctor for||
8060|176|N|more details.||
8060|177|B|||
8060|178|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8060|179|D|remember. If it is near the time of the next dose, skip the||
8060|180|D|missed dose. Take your next dose at the regular time. Do not||
8060|181|D|double the dose to catch up. See also How to Use section.||
8060|182|B|||
8060|183|R|STORAGE:  Store at room temperature away from light and moisture.||
8060|184|R|Do not store in the bathroom. Keep all medications away from||
8060|185|R|children and pets.||
8060|186|R|   Do not flush medications down the toilet or pour them into a||
8060|187|R|drain unless instructed to do so. Properly discard this product||
8060|188|R|when it is expired or no longer needed. Consult your pharmacist||
8060|189|R|or local waste disposal company.||
8060|190|B|||
8060|191|A|Information last revised May 2025.||
8060|192|A|Copyright(c) 2025 First Databank, Inc.||
8060|193|B|||
8061|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8061|002|Z|does NOT have all possible information about this product. This||
8061|003|Z|information does not assure that this product is safe, effective,||
8061|004|Z|or appropriate for you. This information is not individual||
8061|005|Z|medical advice and does not substitute for the advice of your||
8061|006|Z|health care professional. Always ask your health care||
8061|007|Z|professional for complete information about this product and your||
8061|008|Z|specific health needs.||
8061|009|B|||
8061|010|T|GLICLAZIDE - ORAL||
8061|011|F|(GLICK-luh-zide)||
8061|012|B|||
8061|013|U|USES:  Gliclazide is used with a proper diet and exercise program||
8061|014|U|to control high blood sugar in people with type 2 diabetes.||
8061|015|U|Controlling high blood sugar helps prevent kidney damage,||
8061|016|U|blindness, nerve problems, loss of limbs, and sexual function||
8061|017|U|problems. Proper control of diabetes may also lessen your risk of||
8061|018|U|a heart attack or stroke. Gliclazide belongs to the class of||
8061|019|U|drugs known as sulfonylureas. It lowers blood sugar by causing||
8061|020|U|the release of your body's natural insulin.||
8061|021|B|||
8061|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8061|023|H|from your pharmacist before you start using gliclazide and each||
8061|024|H|time you get a refill. If you have any questions, ask your doctor||
8061|025|H|or pharmacist.||
8061|026|H|   Take this medication by mouth with a meal as directed by your||
8061|027|H|doctor, usually once or twice daily. The dosage is based on your||
8061|028|H|medical condition and response to treatment.||
8061|029|H|   To reduce your risk of side effects, your doctor may direct||
8061|030|H|you to start this medication at a low dose and gradually increase||
8061|031|H|your dose. Follow your doctor's instructions carefully.||
8061|032|H|   Use this medication regularly to get the most benefit from it.||
8061|033|H|To help you remember, take it at the same time(s) each day.||
8061|034|H|   Tell your doctor if your condition does not get better or if||
8061|035|H|it gets worse (your blood sugar is too high or too low).||
8061|036|B|||
8061|037|S|SIDE EFFECTS:  Nausea, stomach upset, or diarrhea may occur. If||
8061|038|S|any of these effects last or get worse, tell your doctor or||
8061|039|S|pharmacist promptly.||
8061|040|S|   Remember that this medication has been prescribed because your||
8061|041|S|doctor has judged that the benefit to you is greater than the||
8061|042|S|risk of side effects. Many people using this medication do not||
8061|043|S|have serious side effects.||
8061|044|S|   Tell your doctor right away if you have any serious side||
8061|045|S|effects, including: signs of infection (such as sore throat that||
8061|046|S|doesn't go away, fever, chills), easy bleeding/bruising, signs of||
8061|047|S|liver disease (such as stomach/abdominal pain, yellowing||
8061|048|S|eyes/skin, dark urine), unusual/sudden weight gain, mental/mood||
8061|049|S|changes, swelling hands/feet, unusual tiredness/weakness.||
8061|050|S|   This medication can cause low blood sugar (hypoglycemia). This||
8061|051|S|may occur if you do not get enough calories from food or if you||
8061|052|S|do unusually heavy exercise. Symptoms of low blood sugar include||
8061|053|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
8061|054|S|dizziness, or tingling hands/feet. It is a good habit to carry||
8061|055|S|glucose tablets or gel to treat low blood sugar. If you don't||
8061|056|S|have these reliable forms of glucose, rapidly raise your blood||
8061|057|S|sugar by eating a quick source of sugar such as table sugar,||
8061|058|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
8061|059|S|doctor right away about the reaction and the use of this product.||
8061|060|S|To help prevent low blood sugar, eat meals on a regular schedule,||
8061|061|S|and do not skip meals. Check with your doctor or pharmacist to||
8061|062|S|find out what you should do if you miss a meal.||
8061|063|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
8061|064|S|thirst/urination. If these symptoms occur, tell your doctor right||
8061|065|S|away. Your doctor may need to adjust your diabetes medication,||
8061|066|S|exercise program, or diet.||
8061|067|S|   A very serious allergic reaction to this drug is rare.||
8061|068|S|However, get medical help right away if you notice any symptoms||
8061|069|S|of a serious allergic reaction, including: rash, itching/swelling||
8061|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8061|071|S|breathing.||
8061|072|S|   This is not a complete list of possible side effects. If you||
8061|073|S|notice other effects not listed above, contact your doctor or||
8061|074|S|pharmacist.||
8061|075|S|   In the US -||
8061|076|S|   Call your doctor for medical advice about side effects. You||
8061|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8061|078|S|www.fda.gov/medwatch.||
8061|079|S|   In Canada - Call your doctor for medical advice about side||
8061|080|S|effects. You may report side effects to Health Canada at||
8061|081|S|1-866-234-2345.||
8061|082|B|||
8061|083|P|PRECAUTIONS:  Before taking gliclazide, tell your doctor or||
8061|084|P|pharmacist if you are allergic to it; or to other sulfonylureas||
8061|085|P|(such as glipizide); or if you have any other allergies. This||
8061|086|P|product may contain inactive ingredients, which can cause||
8061|087|P|allergic reactions or other problems. Talk to your pharmacist for||
8061|088|P|more details.||
8061|089|P|   Before using this medication, tell your doctor or pharmacist||
8061|090|P|your medical history, especially of: bleeding problems, liver||
8061|091|P|problems, kidney problems, thyroid disease, a certain metabolic||
8061|092|P|problem (porphyria), certain hormonal conditions||
8061|093|P|(adrenal/pituitary insufficiency).||
8061|094|P|   You may experience blurred vision, dizziness, or drowsiness||
8061|095|P|due to extremely low or high blood sugar. Do not drive, use||
8061|096|P|machinery, or do anything that needs alertness or clear vision||
8061|097|P|until you can do it safely.||
8061|098|P|   Limit alcohol while taking this medication because it can||
8061|099|P|increase your risk of developing low blood sugar. Rarely, alcohol||
8061|100|P|can interact with gliclazide and cause a serious reaction with||
8061|101|P|symptoms such as facial flushing, nausea, vomiting, dizziness, or||
8061|102|P|stomach pain. If you notice any of these effects, tell your||
8061|103|P|doctor right away.||
8061|104|P|   It may be harder to control your blood sugar when your body is||
8061|105|P|stressed (such as due to fever, infection, injury, or surgery).||
8061|106|P|Consult your doctor because this may require a change in your||
8061|107|P|treatment plan, medications, or blood sugar testing.||
8061|108|P|   This medication may make you more sensitive to the sun. Limit||
8061|109|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8061|110|P|sunscreen and wear protective clothing when outdoors. Tell your||
8061|111|P|doctor right away if you get sunburned or have skin||
8061|112|P|blisters/redness.||
8061|113|P|   Before having surgery, tell your doctor or dentist about all||
8061|114|P|the products you use (including prescription drugs,||
8061|115|P|nonprescription drugs, and herbal products).||
8061|116|P|   Older adults may be more sensitive to the side effects of the||
8061|117|P|drug, especially low blood sugar.||
8061|118|P|   Tell your doctor if you are pregnant or plan to become||
8061|119|P|pregnant. You should not become pregnant while using gliclazide.||
8061|120|P|Gliclazide may harm an unborn baby. If you become pregnant, talk||
8061|121|P|to your doctor right away about the risks and benefits of this||
8061|122|P|medication.||
8061|123|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
8061|124|P|your doctor for managing your blood sugar while pregnant. Your||
8061|125|P|doctor may change your diabetes treatment during your pregnancy||
8061|126|P|(such as diet and medications including insulin).||
8061|127|P|   It is unknown if this drug passes into breast milk. Because of||
8061|128|P|the possible risk to the infant, breastfeeding is not recommended||
8061|129|P|while using this drug. Consult your doctor before breastfeeding.||
8061|130|B|||
8061|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8061|132|I|medications work or increase your risk for serious side effects.||
8061|133|I|This document does not contain all possible drug interactions.||
8061|134|I|Keep a list of all the products you use (including||
8061|135|I|prescription/nonprescription drugs and herbal products) and share||
8061|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
8061|137|I|the dosage of any medicines without your doctor's approval.||
8061|138|I|   Many drugs can affect your blood sugar, making it harder to||
8061|139|I|control. Before you start, stop, or change any medication, talk||
8061|140|I|with your doctor or pharmacist about how the medication may||
8061|141|I|affect your blood sugar. Check your blood sugar regularly as||
8061|142|I|directed and share the results with your doctor. Tell your doctor||
8061|143|I|right away if you have symptoms of high or low blood sugar. (See||
8061|144|I|also Side Effects section.) Your doctor may need to adjust your||
8061|145|I|diabetes medication, exercise program, or diet.||
8061|146|I|   Beta blocker medications (such as metoprolol, propranolol,||
8061|147|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
8061|148|I|heartbeat you would usually feel when your blood sugar falls too||
8061|149|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
8061|150|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
8061|151|B|||
8061|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8061|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8061|154|O|poison control center right away. US residents can call||
8061|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8061|156|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
8061|157|O|sweating, loss of consciousness.||
8061|158|B|||
8061|159|N|NOTES:  Do not share this medication with others.||
8061|160|N|   Attend a diabetes education program to learn more about how to||
8061|161|N|manage your diabetes with medications, diet, exercise, and||
8061|162|N|regular medical exams.||
8061|163|N|   Learn the symptoms of high and low blood sugar and how to||
8061|164|N|treat low blood sugar. Check your blood sugar regularly as||
8061|165|N|directed.||
8061|166|N|   Lab and/or medical tests (such as kidney/liver function,||
8061|167|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
8061|168|N|should be done while you are taking this medication. Keep all||
8061|169|N|medical and lab appointments.||
8061|170|B|||
8061|171|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
8061|172|D|you remember. If it is near the time of the next dose, skip the||
8061|173|D|missed dose. Take your next dose at the regular time. Do not||
8061|174|D|double the dose to catch up.||
8061|175|B|||
8061|176|R|STORAGE:  Store at room temperature away from light and moisture.||
8061|177|R|Do not store in the bathroom. Keep all medications away from||
8061|178|R|children and pets.||
8061|179|R|   Do not flush medications down the toilet or pour them into a||
8061|180|R|drain unless instructed to do so. Properly discard this product||
8061|181|R|when it is expired or no longer needed. Consult your pharmacist||
8061|182|R|or local waste disposal company.||
8061|183|B|||
8061|184|M|MEDICAL ALERT:  Your condition can cause complications in a||
8061|185|M|medical emergency. For information about enrolling in MedicAlert,||
8061|186|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8061|187|B|||
8061|188|A|Information last revised May 2025.||
8061|189|A|Copyright(c) 2025 First Databank, Inc.||
8061|190|B|||
8063|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8063|002|Z|does NOT have all possible information about this product. This||
8063|003|Z|information does not assure that this product is safe, effective,||
8063|004|Z|or appropriate for you. This information is not individual||
8063|005|Z|medical advice and does not substitute for the advice of your||
8063|006|Z|health care professional. Always ask your health care||
8063|007|Z|professional for complete information about this product and your||
8063|008|Z|specific health needs.||
8063|009|B|||
8063|010|T|PERMETHRIN CREAM - TOPICAL||
8063|011|F|(purr-METH-rin)||
8063|012|B|||
8063|013|C|COMMON BRAND NAME(S): Elimite||
8063|014|B|||
8063|015|U|USES:  This medication is used to treat scabies, a condition||
8063|016|U|caused by tiny insects called mites that infest and irritate your||
8063|017|U|skin. Permethrin belongs to a class of drugs known as pyrethrins.||
8063|018|U|Permethrin works by paralyzing and killing the mites and their||
8063|019|U|eggs.||
8063|020|B|||
8063|021|H|HOW TO USE:  This medication is for use on the skin only. Apply||
8063|022|H|this medication as soon as possible after it is prescribed. Apply||
8063|023|H|the medicine from your head to the soles of your feet, including||
8063|024|H|under your nails and in skin folds such as between the toes, as||
8063|025|H|directed. Massage the cream into the skin. Do not use more||
8063|026|H|medication than prescribed. Wash off the cream after 8-14 hours||
8063|027|H|by showering or taking a bath.||
8063|028|H|   Avoid getting the cream into your eyes, nose, mouth, or||
8063|029|H|vagina. If the medication gets in your eyes, flush the eyes with||
8063|030|H|plenty of water. Consult your doctor if irritation lasts.||
8063|031|H|   Symptoms of scabies include an intense itching that is usually||
8063|032|H|worse at bedtime. You may also see small, fine, wavy lines on the||
8063|033|H|skin with a tiny insect at the end (a burrow). Burrows are||
8063|034|H|usually found on finger/toe webs, wrists, elbows, armpits, belt||
8063|035|H|line, lower buttocks, female nipples, or male genitals. Even if||
8063|036|H|permethrin kills all the scabies, the dead mites can still make||
8063|037|H|you itch for up to 4 weeks after treatment. Ask your doctor about||
8063|038|H|other medications that may be used to soothe the itching. Tell||
8063|039|H|your doctor if your condition lasts or gets worse 2 weeks after||
8063|040|H|treatment. Your doctor may need to look for living mites and||
8063|041|H|recommend more treatment.||
8063|042|B|||
8063|043|S|SIDE EFFECTS:  Skin irritation, including itching, swelling, and||
8063|044|S|redness, may occur with scabies and temporarily worsen after||
8063|045|S|treatment with permethrin. Mild burning or stinging may also||
8063|046|S|occur. If any of these effects last or get worse, tell your||
8063|047|S|doctor or pharmacist promptly.||
8063|048|S|   Remember that this medication has been prescribed because your||
8063|049|S|doctor has judged that the benefit to you is greater than the||
8063|050|S|risk of side effects. Many people using this medication do not||
8063|051|S|have serious side effects.||
8063|052|S|   A very serious allergic reaction to this drug is rare.||
8063|053|S|However, get medical help right away if you notice any symptoms||
8063|054|S|of a serious allergic reaction, including: rash, itching/swelling||
8063|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8063|056|S|breathing.||
8063|057|S|   This is not a complete list of possible side effects. If you||
8063|058|S|notice other effects not listed above, contact your doctor or||
8063|059|S|pharmacist.||
8063|060|S|   In the US -||
8063|061|S|   Call your doctor for medical advice about side effects. You||
8063|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8063|063|S|www.fda.gov/medwatch.||
8063|064|S|   In Canada - Call your doctor for medical advice about side||
8063|065|S|effects. You may report side effects to Health Canada at||
8063|066|S|1-866-234-2345.||
8063|067|B|||
8063|068|P|PRECAUTIONS:  Before using permethrin, tell your doctor or||
8063|069|P|pharmacist if you are allergic to it; or if you have any other||
8063|070|P|allergies. This product may contain inactive ingredients, which||
8063|071|P|can cause allergic reactions or other problems. Talk to your||
8063|072|P|pharmacist for more details.||
8063|073|P|   Before using this medication, tell your doctor or pharmacist||
8063|074|P|your medical history, especially of: skin infections, asthma.||
8063|075|P|   Constant or forceful scratching of the skin/scalp may lead to||
8063|076|P|a bacterial skin infection. Tell your doctor right away if you||
8063|077|P|develop worsening redness or pus.||
8063|078|P|   Tell your doctor if you are pregnant before using this||
8063|079|P|medication.||
8063|080|P|   It is unknown if this drug passes into breast milk but is||
8063|081|P|unlikely to harm a nursing infant. Consult your doctor before||
8063|082|P|breastfeeding.||
8063|083|B|||
8063|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8063|085|I|medications work or increase your risk for serious side effects.||
8063|086|I|This document does not contain all possible drug interactions.||
8063|087|I|Keep a list of all the products you use (including||
8063|088|I|prescription/nonprescription drugs and herbal products) and share||
8063|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
8063|090|I|the dosage of any medicines without your doctor's approval.||
8063|091|B|||
8063|092|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8063|093|O|has overdosed and has serious symptoms such as passing out or||
8063|094|O|trouble breathing, call 911. Otherwise, call a poison control||
8063|095|O|center right away. US residents can call 1-800-222-1222. Canada||
8063|096|O|residents can call 1-844-764-7669. Symptoms of overdose may||
8063|097|O|include: dizziness, severe headache, severe vomiting, weakness,||
8063|098|O|seizures.||
8063|099|B|||
8063|100|N|NOTES:  Do not share this medication with others.||
8063|101|N|   One application is usually all that is needed. To avoid giving||
8063|102|N|scabies to another person or getting it again, clothing and bed||
8063|103|N|linens that have been in contact with your skin less than 2 days||
8063|104|N|before treatment should be machine-washed with hot water and||
8063|105|N|dried in a hot dryer for 20 minutes, dry cleaned, or removed from||
8063|106|N|body contact for 72 hours.||
8063|107|N|   People who are in close contact with the infected person, such||
8063|108|N|as members of the same household, should also be checked for||
8063|109|N|scabies.||
8063|110|B|||
8063|111|D|MISSED DOSE:  Not applicable.||
8063|112|B|||
8063|113|R|STORAGE:  Store at room temperature. Keep all medications away||
8063|114|R|from children and pets.||
8063|115|R|   Do not flush medications down the toilet or pour them into a||
8063|116|R|drain unless instructed to do so. Properly discard this product||
8063|117|R|when it is expired or no longer needed. Consult your pharmacist||
8063|118|R|or local waste disposal company.||
8063|119|B|||
8063|120|A|Information last revised May 2024.||
8063|121|A|Copyright(c) 2025 First Databank, Inc.||
8063|122|B|||
8065|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8065|002|Z|does NOT have all possible information about this product. This||
8065|003|Z|information does not assure that this product is safe, effective,||
8065|004|Z|or appropriate for you. This information is not individual||
8065|005|Z|medical advice and does not substitute for the advice of your||
8065|006|Z|health care professional. Always ask your health care||
8065|007|Z|professional for complete information about this product and your||
8065|008|Z|specific health needs.||
8065|009|B|||
8065|010|T|RIFAMPIN - INJECTION||
8065|011|F|(rif-AM-pin)||
8065|012|B|||
8065|013|C|COMMON BRAND NAME(S): Rifadin||
8065|014|B|||
8065|015|U|USES:  This medication is used to prevent and treat tuberculosis||
8065|016|U|and other bacterial infections. Rifampin belongs to a class of||
8065|017|U|drugs known as rifamycin antibiotics. It works by stopping the||
8065|018|U|growth of bacteria.||
8065|019|B|||
8065|020|H|HOW TO USE:  This medication is given by injection into a vein as||
8065|021|H|directed by your doctor, usually once or twice daily. It is||
8065|022|H|injected slowly into a vein over 30 minutes.||
8065|023|H|   If you are using this medication at home, learn all||
8065|024|H|preparation and usage instructions from your health care||
8065|025|H|professional. Before using, check this product for particles or||
8065|026|H|discoloration. If either is present, do not use the liquid. Learn||
8065|027|H|how to store and discard medical supplies safely.||
8065|028|H|   The dosage and length of treatment are based on your medical||
8065|029|H|condition, weight, and response to treatment.||
8065|030|H|   It is very important to keep using this medication (and other||
8065|031|H|medications used to treat tuberculosis) exactly as prescribed by||
8065|032|H|your doctor. Do not skip any doses.||
8065|033|H|   For the best effect, use this antibiotic at evenly spaced||
8065|034|H|times. To help you remember, use this medication at the same||
8065|035|H|time(s) every day.||
8065|036|H|   Continue to use this medication until the full prescribed||
8065|037|H|amount is finished, even if symptoms disappear after a few days.||
8065|038|H|Stopping the medication too early may result in a return of the||
8065|039|H|infection.||
8065|040|H|   Tell your doctor if your condition lasts or gets worse.||
8065|041|B|||
8065|042|S|SIDE EFFECTS:  Upset stomach, heartburn, nausea, or headache may||
8065|043|S|occur. If any of these effects last or get worse, tell your||
8065|044|S|doctor or pharmacist promptly.||
8065|045|S|   This medication may cause urine, sweat, saliva, or tears to||
8065|046|S|change color (yellow, orange, red, or brown). This effect is||
8065|047|S|harmless and will disappear when the medication is stopped.||
8065|048|S|However, teeth and contact lens staining may be permanent.||
8065|049|S|   Remember that this medication has been prescribed because your||
8065|050|S|doctor has judged that the benefit to you is greater than the||
8065|051|S|risk of side effects. Many people using this medication do not||
8065|052|S|have serious side effects.||
8065|053|S|   Tell your doctor right away if you have any serious side||
8065|054|S|effects, including: signs of kidney problems (such as change in||
8065|055|S|the amount of urine), mental/mood changes (such as confusion,||
8065|056|S|unusual behavior), unusual tiredness, easy bruising/bleeding,||
8065|057|S|small red spots on the skin, joint pain/swelling, new or||
8065|058|S|worsening shortness of breath.||
8065|059|S|   Get medical help right away if you have any very serious side||
8065|060|S|effects, including: chest pain.||
8065|061|S|   Rifampin may rarely cause serious (possibly fatal) liver||
8065|062|S|disease. Get medical help right away if you have any symptoms of||
8065|063|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
8065|064|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
8065|065|S|urine.||
8065|066|S|   This medication may rarely cause a severe intestinal condition||
8065|067|S|due to a bacteria called C. difficile. This condition may occur||
8065|068|S|during treatment or weeks to months after treatment has stopped.||
8065|069|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8065|070|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8065|071|S|stool.||
8065|072|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8065|073|S|products because they may make symptoms worse.||
8065|074|S|   This medication may sometimes cause oral thrush or a new yeast||
8065|075|S|infection. Contact your doctor if you notice white patches in||
8065|076|S|your mouth, a change in vaginal discharge, or other new symptoms.||
8065|077|S|   A very serious allergic reaction to this drug is rare.||
8065|078|S|However, get medical help right away if you notice any symptoms||
8065|079|S|of a serious allergic reaction, including: fever that doesn't go||
8065|080|S|away, new or worsening lymph node swelling, rash,||
8065|081|S|itching/swelling (especially of the face/tongue/throat), severe||
8065|082|S|dizziness, trouble breathing.||
8065|083|S|   This is not a complete list of possible side effects. If you||
8065|084|S|notice other effects not listed above, contact your doctor or||
8065|085|S|pharmacist.||
8065|086|S|   In the US -||
8065|087|S|   Call your doctor for medical advice about side effects. You||
8065|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8065|089|S|www.fda.gov/medwatch.||
8065|090|S|   In Canada - Call your doctor for medical advice about side||
8065|091|S|effects. You may report side effects to Health Canada at||
8065|092|S|1-866-234-2345.||
8065|093|B|||
8065|094|P|PRECAUTIONS:  Before using rifampin, tell your doctor or||
8065|095|P|pharmacist if you are allergic to it; or other rifamycins (such||
8065|096|P|as rifabutin); or if you have any other allergies. This product||
8065|097|P|may contain inactive ingredients, which can cause allergic||
8065|098|P|reactions or other problems. Talk to your pharmacist for more||
8065|099|P|details.||
8065|100|P|   Before using this medication, tell your doctor or pharmacist||
8065|101|P|your medical history, especially of: diabetes, liver problems||
8065|102|P|(such as hepatitis), HIV infection, history of alcohol use/abuse.||
8065|103|P|   Alcohol may increase the risk of liver disease. Avoid||
8065|104|P|alcoholic beverages while using this medication.||
8065|105|P|   Rifampin may cause live bacterial vaccines (such as typhoid||
8065|106|P|vaccine) to not work well. Tell your health care professional||
8065|107|P|that you are using rifampin before having any||
8065|108|P|immunizations/vaccinations.||
8065|109|P|   Before having surgery, tell your doctor or dentist about all||
8065|110|P|the products you use (including prescription drugs,||
8065|111|P|nonprescription drugs, and herbal products).||
8065|112|P|   During pregnancy, this medication should be used only when||
8065|113|P|clearly needed. When this drug is used during the last few weeks||
8065|114|P|of pregnancy, the risk of bleeding in both mother and infant may||
8065|115|P|be increased. Tell your doctor right away if you notice any||
8065|116|P|bleeding in your newborn. Discuss the risks and benefits with||
8065|117|P|your doctor.||
8065|118|P|   Rifampin passes into breast milk but is unlikely to harm a||
8065|119|P|nursing infant. Consult your doctor before breastfeeding.||
8065|120|B|||
8065|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8065|122|I|medications work or increase your risk for serious side effects.||
8065|123|I|This document does not contain all possible drug interactions.||
8065|124|I|Keep a list of all the products you use (including||
8065|125|I|prescription/nonprescription drugs and herbal products) and share||
8065|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
8065|127|I|the dosage of any medicines without your doctor's approval.||
8065|128|I|   Rifampin interacts with many medications. While you are using||
8065|129|I|rifampin, it is very important to tell your doctor or pharmacist||
8065|130|I|of any changes in medications that you are taking.||
8065|131|I|   Rifampin can speed up the removal of other medications from||
8065|132|I|your body, which may affect how they work. Examples of affected||
8065|133|I|drugs include atovaquone, certain anti-cancer drugs (such as||
8065|134|I|irinotecan), certain azole antifungals (such as itraconazole),||
8065|135|I|certain calcium channel blockers (such as nifedipine), certain||
8065|136|I|products used to treat chronic hepatitis C (such as sofosbuvir),||
8065|137|I|cobicistat, lurasidone, HIV NNRTIs (such as etravirine,||
8065|138|I|nevirapine), praziquantel, HIV protease inhibitors (such as||
8065|139|I|atazanavir, darunavir), among others.||
8065|140|I|   This medication may decrease the effectiveness of hormonal||
8065|141|I|birth control such as pills, patch, or ring. This could cause||
8065|142|I|pregnancy. Discuss with your doctor or pharmacist if you should||
8065|143|I|use reliable backup birth control methods while using this||
8065|144|I|medication. Also tell your doctor if you have any new spotting or||
8065|145|I|breakthrough bleeding, because these may be signs that your birth||
8065|146|I|control is not working well.||
8065|147|I|   This medication may interfere with certain lab tests (such as||
8065|148|I|urine screening for opiates, blood serum folate/vitamin B12),||
8065|149|I|possibly causing false test results. Rifampin may also make it||
8065|150|I|harder for your body to get rid of certain chemicals used in||
8065|151|I|gallbladder tests. Make sure lab personnel and all your doctors||
8065|152|I|know you use this drug.||
8065|153|B|||
8065|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8065|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8065|156|O|poison control center right away. US residents can call||
8065|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8065|158|B|||
8065|159|N|NOTES:  Lab and/or medical tests (such as liver/kidney function,||
8065|160|N|bilirubin, complete blood count) may be done before you start||
8065|161|N|using this medication and while you are using it. Keep all||
8065|162|N|medical and lab appointments. Consult your doctor for more||
8065|163|N|details.||
8065|164|B|||
8065|165|D|MISSED DOSE:  It is important to get each dose of this medication||
8065|166|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8065|167|D|right away for a new dosing schedule. Do not double the dose to||
8065|168|D|catch up.||
8065|169|B|||
8065|170|R|STORAGE:  Consult the product instructions and your pharmacist||
8065|171|R|for storage details. Keep all medications away from children and||
8065|172|R|pets.||
8065|173|R|   Do not flush medications down the toilet or pour them into a||
8065|174|R|drain unless instructed to do so. Properly discard this product||
8065|175|R|when it is expired or no longer needed. Consult your pharmacist||
8065|176|R|or local waste disposal company.||
8065|177|B|||
8065|178|A|Information last revised December 2024.||
8065|179|A|Copyright(c) 2025 First Databank, Inc.||
8065|180|B|||
8066|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8066|002|Z|does NOT have all possible information about this product. This||
8066|003|Z|information does not assure that this product is safe, effective,||
8066|004|Z|or appropriate for you. This information is not individual||
8066|005|Z|medical advice and does not substitute for the advice of your||
8066|006|Z|health care professional. Always ask your health care||
8066|007|Z|professional for complete information about this product and your||
8066|008|Z|specific health needs.||
8066|009|B|||
8066|010|T|METOLAZONE - ORAL||
8066|011|F|(me-TOLE-a-zone)||
8066|012|B|||
8066|013|C|COMMON BRAND NAME(S): Zaroxolyn||
8066|014|B|||
8066|015|U|USES:  Metolazone is a "water pill" (diuretic) that increases the||
8066|016|U|amount of urine you make, which causes your body to get rid of||
8066|017|U|excess water. This drug is used to treat high blood pressure.||
8066|018|U|Lowering high blood pressure helps prevent strokes, heart||
8066|019|U|attacks, and kidney problems.||
8066|020|U|   This medication also reduces swelling/fluid retention (edema)||
8066|021|U|which can result from conditions such as heart failure or kidney||
8066|022|U|disease. This can help to improve symptoms such as trouble||
8066|023|U|breathing.||
8066|024|B|||
8066|025|H|HOW TO USE:  Take this medication by mouth with or without food||
8066|026|H|as directed by your doctor, usually once daily. The dosage is||
8066|027|H|based on your medical condition and response to treatment.||
8066|028|H|   If you take this drug too close to bedtime, you may need to||
8066|029|H|wake up to urinate. It is best to take this medication at least 4||
8066|030|H|hours before your bedtime.||
8066|031|H|   Use this medication regularly in order to get the most benefit||
8066|032|H|from it. Remember to use it at the same time each day as||
8066|033|H|directed. Keep taking this medication even if you feel well. Most||
8066|034|H|people with high blood pressure do not feel sick. Do not stop||
8066|035|H|taking this medication without consulting your doctor. It may||
8066|036|H|take up to 3 to 6 weeks to see a lowering of your blood pressure.||
8066|037|H|   Cholestyramine and colestipol can decrease the absorption of||
8066|038|H|metolazone. If you are taking either of these drugs, separate||
8066|039|H|metolazone from cholestyramine by at least 4 hours and from||
8066|040|H|colestipol by at least 2 hours.||
8066|041|H|   If your condition lasts or gets worse, tell your doctor or||
8066|042|H|pharmacist.||
8066|043|B|||
8066|044|S|SIDE EFFECTS:  Dizziness, lightheadedness, headache, blurred||
8066|045|S|vision, loss of appetite, stomach upset, diarrhea, or||
8066|046|S|constipation may occur as your body adjusts to the medication. If||
8066|047|S|any of these effects last or get worse, tell your doctor or||
8066|048|S|pharmacist promptly.||
8066|049|S|   To reduce the risk of dizziness and lightheadedness, get up||
8066|050|S|slowly when rising from a sitting or lying position.||
8066|051|S|   Remember that this medication has been prescribed because your||
8066|052|S|doctor has judged that the benefit to you is greater than the||
8066|053|S|risk of side effects. Many people using this medication do not||
8066|054|S|have serious side effects.||
8066|055|S|   This medication may cause dehydration and electrolyte||
8066|056|S|imbalance. Tell your doctor right away if you have any symptoms||
8066|057|S|of dehydration or electrolyte imbalance, including unusual dry||
8066|058|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
8066|059|S|heartbeat, or confusion.||
8066|060|S|   Tell your doctor right away if you have any serious side||
8066|061|S|effects, including: fainting, numbness/tingling of the arms/legs,||
8066|062|S|decreased sexual ability, easy bleeding/bruising, signs of liver||
8066|063|S|problems (such as nausea/vomiting that doesn't stop, yellowing||
8066|064|S|eyes/skin, stomach/abdominal pain), signs of kidney problems||
8066|065|S|(such as change in the amount of urine), decrease in vision, eye||
8066|066|S|pain.||
8066|067|S|   A very serious allergic reaction to this drug is rare.||
8066|068|S|However, get medical help right away if you notice any symptoms||
8066|069|S|of a serious allergic reaction, including: rash, itching/swelling||
8066|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8066|071|S|breathing.||
8066|072|S|   This is not a complete list of possible side effects. If you||
8066|073|S|notice other effects not listed above, contact your doctor or||
8066|074|S|pharmacist.||
8066|075|S|   In the US -||
8066|076|S|   Call your doctor for medical advice about side effects. You||
8066|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8066|078|S|www.fda.gov/medwatch.||
8066|079|S|   In Canada - Call your doctor for medical advice about side||
8066|080|S|effects. You may report side effects to Health Canada at||
8066|081|S|1-866-234-2345.||
8066|082|B|||
8066|083|P|PRECAUTIONS:  Before taking metolazone, tell your doctor or||
8066|084|P|pharmacist if you are allergic to it; or if you have any other||
8066|085|P|allergies. This product may contain inactive ingredients, which||
8066|086|P|can cause allergic reactions or other problems. Talk to your||
8066|087|P|pharmacist for more details.||
8066|088|P|   Before using this medication, tell your doctor or pharmacist||
8066|089|P|your medical history, especially of: kidney disease, liver||
8066|090|P|disease, untreated mineral imbalance (such as sodium, potassium),||
8066|091|P|gout, lupus.||
8066|092|P|   If you have diabetes, metolazone may affect your blood sugar.||
8066|093|P|Check your blood sugar regularly as directed and share the||
8066|094|P|results with your doctor. Tell your doctor right away if you have||
8066|095|P|symptoms of high blood sugar such as increased thirst/urination.||
8066|096|P|Your doctor may need to adjust your diabetes medication, exercise||
8066|097|P|program, or diet.||
8066|098|P|   This drug may reduce the potassium levels in your blood. Ask||
8066|099|P|your doctor about adding potassium to your diet. A potassium||
8066|100|P|supplement may be prescribed by your doctor.||
8066|101|P|   This medication may make you more sensitive to the sun. Limit||
8066|102|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8066|103|P|sunscreen and wear protective clothing when outdoors. Tell your||
8066|104|P|doctor right away if you get sunburned or have skin||
8066|105|P|blisters/redness.||
8066|106|P|   Before having surgery, tell your doctor or dentist about all||
8066|107|P|the products you use (including prescription drugs,||
8066|108|P|nonprescription drugs, and herbal products).||
8066|109|P|   This drug may make you dizzy or blur your vision. Alcohol or||
8066|110|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
8066|111|P|machinery, or do anything that needs alertness or clear vision||
8066|112|P|until you can do it safely. Limit alcoholic beverages. Talk to||
8066|113|P|your doctor if you are using marijuana (cannabis).||
8066|114|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
8066|115|P|and cause you to feel lightheaded. Tell your doctor if you have||
8066|116|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
8066|117|P|of fluids unless your doctor tells you not to.||
8066|118|P|   Older adults may be more sensitive to the side effects of this||
8066|119|P|drug, especially dizziness.||
8066|120|P|   During pregnancy, metolazone should be used only when clearly||
8066|121|P|needed. Discuss the risks and benefits with your doctor.||
8066|122|P|   This drug passes into breast milk. Consult your doctor before||
8066|123|P|breastfeeding.||
8066|124|B|||
8066|125|I|DRUG INTERACTIONS:  See also the How to Use section.||
8066|126|I|   Drug interactions may change how your medications work or||
8066|127|I|increase your risk for serious side effects. This document does||
8066|128|I|not contain all possible drug interactions. Keep a list of all||
8066|129|I|the products you use (including prescription/nonprescription||
8066|130|I|drugs and herbal products) and share it with your doctor and||
8066|131|I|pharmacist. Do not start, stop, or change the dosage of any||
8066|132|I|medicines without your doctor's approval.||
8066|133|I|   Some products that may interact with this drug include:||
8066|134|I|digoxin, dofetilide, lithium.||
8066|135|I|   Some products have ingredients that could raise your blood||
8066|136|I|pressure or worsen your swelling. Tell your pharmacist what||
8066|137|I|products you are using, and ask how to use them safely||
8066|138|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
8066|139|I|ibuprofen/naproxen).||
8066|140|I|   This medication may interfere with certain lab tests (such as||
8066|141|I|parathyroid function tests), possibly causing false test results.||
8066|142|I|Make sure lab personnel and all your doctors know you use this||
8066|143|I|drug.||
8066|144|B|||
8066|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8066|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8066|147|O|poison control center right away. US residents can call||
8066|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8066|149|O|Symptoms of overdose may include fainting, severe weakness, a||
8066|150|O|severe decrease in amount of urine, or slow or shallow breathing.||
8066|151|B|||
8066|152|N|NOTES:  Do not share this medication with others.||
8066|153|N|   Lifestyle changes such as stress reduction programs, exercise,||
8066|154|N|and dietary changes may increase the effectiveness of this||
8066|155|N|medicine. Talk to your doctor or pharmacist about lifestyle||
8066|156|N|changes that might benefit you.||
8066|157|N|   Lab and/or medical tests (such as blood mineral levels such as||
8066|158|N|potassium, kidney/liver function) should be done while you are||
8066|159|N|taking this medication. Keep all medical and lab appointments.||
8066|160|N|Consult your doctor for more details.||
8066|161|N|   Have your blood pressure checked regularly while taking this||
8066|162|N|medication. Discuss with your doctor how to monitor your own||
8066|163|N|blood pressure.||
8066|164|B|||
8066|165|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8066|166|D|If it is near the time of the next dose, skip the missed dose.||
8066|167|D|Use your next dose at the regular time. Do not double the dose to||
8066|168|D|catch up.||
8066|169|B|||
8066|170|R|STORAGE:  Store at room temperature away from light and moisture.||
8066|171|R|Do not store in the bathroom. Keep all medications away from||
8066|172|R|children and pets.||
8066|173|R|   Do not flush medications down the toilet or pour them into a||
8066|174|R|drain unless instructed to do so. Properly discard this product||
8066|175|R|when it is expired or no longer needed. Consult your pharmacist||
8066|176|R|or local waste disposal company.||
8066|177|B|||
8066|178|A|Information last revised May 2025.||
8066|179|A|Copyright(c) 2025 First Databank, Inc.||
8066|180|B|||
8069|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8069|002|Z|does NOT have all possible information about this product. This||
8069|003|Z|information does not assure that this product is safe, effective,||
8069|004|Z|or appropriate for you. This information is not individual||
8069|005|Z|medical advice and does not substitute for the advice of your||
8069|006|Z|health care professional. Always ask your health care||
8069|007|Z|professional for complete information about this product and your||
8069|008|Z|specific health needs.||
8069|009|B|||
8069|010|T|ACYCLOVIR - INJECTION||
8069|011|F|(ay-SYE-kloe-vir)||
8069|012|B|||
8069|013|C|COMMON BRAND NAME(S): Zovirax||
8069|014|B|||
8069|015|U|USES:  This medication is used in certain people to treat||
8069|016|U|outbreaks of herpes simplex infection of the skin (such as on the||
8069|017|U|genitals), mucous membrane areas (such as the mouth, nose), or||
8069|018|U|brain. It is also used in certain people to treat shingles||
8069|019|U|infection. The viruses that cause these infections live in the||
8069|020|U|body quietly until an outbreak occurs. Acyclovir does not cure||
8069|021|U|these infections, but can speed healing of the sores, decrease||
8069|022|U|pain/itching/formation of new sores, and lower the risk of other||
8069|023|U|problems from the virus (such as infection spreading to other||
8069|024|U|parts of the body/organs, pain even after the sores heal).||
8069|025|B|||
8069|026|H|HOW TO USE:  This medication is given by injection into a vein as||
8069|027|H|directed by your doctor, usually every 8 hours. It should be||
8069|028|H|injected slowly over 1 hour. Do not inject rapidly. Start this||
8069|029|H|medication as soon as signs or symptoms of a herpes infection||
8069|030|H|occur. The dosage is based on your medical condition, weight, and||
8069|031|H|response to treatment.||
8069|032|H|   If you are using this medication at home, learn all||
8069|033|H|preparation and usage instruction from your health care||
8069|034|H|professional. Before using, check this product for particles or||
8069|035|H|discoloration. If either is present, do not use the liquid. Learn||
8069|036|H|how to store and discard medical supplies safely.||
8069|037|H|   This medication works best when the amount of medicine in your||
8069|038|H|body is kept at a constant level. Use this drug at evenly spaced||
8069|039|H|intervals.||
8069|040|H|   Continue to use this medication until the full prescribed||
8069|041|H|amount is finished, even if symptoms disappear after a few days.||
8069|042|H|Stopping the medication too early may result in a return of the||
8069|043|H|outbreak.||
8069|044|H|   Drink plenty of fluids while receiving this medication unless||
8069|045|H|your doctor directs you otherwise.||
8069|046|H|   Tell your doctor if your condition lasts or gets worse.||
8069|047|B|||
8069|048|S|SIDE EFFECTS:  Nausea, vomiting, or loss of appetite may occur.||
8069|049|S|If any of these effects last or get worse, tell your doctor or||
8069|050|S|pharmacist promptly.||
8069|051|S|   Remember that this medication has been prescribed because your||
8069|052|S|doctor has judged that the benefit to you is greater than the||
8069|053|S|risk of side effects. Many people using this medication do not||
8069|054|S|have serious side effects.||
8069|055|S|   Tell your doctor right away if you have any serious side||
8069|056|S|effects, including: pain/swelling at the injection site,||
8069|057|S|dizziness, drowsiness, signs of kidney problems (such as a change||
8069|058|S|in the amount of urine, unusual back/side pain), mental/mood||
8069|059|S|changes (such as agitation, confusion, hallucinations),||
8069|060|S|shaky/unsteady movement, unusual tiredness, fast heartbeat, easy||
8069|061|S|bruising/bleeding, new fever, bloody/dark urine, severe||
8069|062|S|stomach/abdominal pain, yellowing eyes/skin.||
8069|063|S|   Get medical help right away if you have any very serious side||
8069|064|S|effects, including: sudden vision changes, trouble speaking, loss||
8069|065|S|of consciousness, seizures.||
8069|066|S|   A very serious allergic reaction to this drug is rare.||
8069|067|S|However, get medical help right away if you notice any symptoms||
8069|068|S|of a serious allergic reaction, including: fever that doesn't go||
8069|069|S|away, new or worsening lymph node swelling, rash,||
8069|070|S|itching/swelling (especially of the face/tongue/throat), severe||
8069|071|S|dizziness, trouble breathing.||
8069|072|S|   This is not a complete list of possible side effects. If you||
8069|073|S|notice other effects not listed above, contact your doctor or||
8069|074|S|pharmacist.||
8069|075|S|   In the US -||
8069|076|S|   Call your doctor for medical advice about side effects. You||
8069|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8069|078|S|www.fda.gov/medwatch.||
8069|079|S|   In Canada - Call your doctor for medical advice about side||
8069|080|S|effects. You may report side effects to Health Canada at||
8069|081|S|1-866-234-2345.||
8069|082|B|||
8069|083|P|PRECAUTIONS:  Before using acyclovir, tell your doctor or||
8069|084|P|pharmacist if you are allergic to it; or to valacyclovir; or if||
8069|085|P|you have any other allergies. This product may contain inactive||
8069|086|P|ingredients, which can cause allergic reactions or other||
8069|087|P|problems. Talk to your pharmacist for more details.||
8069|088|P|   Before using this medication, tell your doctor or pharmacist||
8069|089|P|your medical history, especially of: kidney disease, liver||
8069|090|P|disease, immune system problems.||
8069|091|P|   This medication contains sodium. Consult your doctor or||
8069|092|P|pharmacist if you are on a salt-restricted diet or if you have a||
8069|093|P|condition that could be worsened by an increase in salt intake||
8069|094|P|(such as heart failure).||
8069|095|P|   Before having surgery, tell your doctor or dentist about all||
8069|096|P|the products you use (including prescription drugs,||
8069|097|P|nonprescription drugs, and herbal products).||
8069|098|P|   Tell your health care professional that you are using||
8069|099|P|acyclovir before having any immunizations/vaccinations (such as||
8069|100|P|vaccines against the varicella virus).||
8069|101|P|   Older adults may be more sensitive to the side effects of the||
8069|102|P|drug, especially mental/mood changes (such as agitation,||
8069|103|P|confusion).||
8069|104|P|   During pregnancy, this medication should be used only when||
8069|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
8069|106|P|   This medication passes into breast milk, but is unlikely to||
8069|107|P|harm a nursing infant. Consult your doctor before breastfeeding.||
8069|108|B|||
8069|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8069|110|I|medications work or increase your risk for serious side effects.||
8069|111|I|This document does not contain all possible drug interactions.||
8069|112|I|Keep a list of all the products you use (including||
8069|113|I|prescription/nonprescription drugs and herbal products) and share||
8069|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
8069|115|I|the dosage of any medicines without your doctor's approval.||
8069|116|I|   Some products that may interact with this drug include: other||
8069|117|I|drugs that may cause kidney problems (including nonsteroidal||
8069|118|I|anti-inflammatory drugs-NSAIDs such as ibuprofen, naproxen).||
8069|119|I|   Acyclovir is very similar to valacyclovir. Do not use||
8069|120|I|medications containing valacyclovir while using acyclovir.||
8069|121|B|||
8069|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8069|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8069|124|O|poison control center right away. US residents can call||
8069|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8069|126|O|Symptoms of overdose may include: change in the amount of urine,||
8069|127|O|seizures, extreme tiredness, loss of consciousness, agitation.||
8069|128|B|||
8069|129|N|NOTES:  To reduce the risk of spreading genital herpes to others,||
8069|130|N|stop all sexual activity during an outbreak until it is||
8069|131|N|completely healed. At all other times, use effective barrier||
8069|132|N|protections (such as latex or polyurethane condoms, dental dams)||
8069|133|N|during all sexual activity. Consult your doctor or pharmacist for||
8069|134|N|more details.||
8069|135|N|   Lab and/or medical tests (such as kidney function) should be||
8069|136|N|done while you are using this medication. Keep all medical and||
8069|137|N|lab appointments. Consult your doctor for more details.||
8069|138|B|||
8069|139|D|MISSED DOSE:  It is important to get each dose of this medication||
8069|140|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8069|141|D|right away for a new dosing schedule. Do not double the dose to||
8069|142|D|catch up.||
8069|143|B|||
8069|144|R|STORAGE:  Consult the product instructions and your pharmacist||
8069|145|R|for storage details. Keep all medications away from children and||
8069|146|R|pets.||
8069|147|R|   Do not flush medications down the toilet or pour them into a||
8069|148|R|drain unless instructed to do so. Properly discard this product||
8069|149|R|when it is expired or no longer needed. Consult your pharmacist||
8069|150|R|or local waste disposal company.||
8069|151|B|||
8069|152|A|Information last revised November 2025.||
8069|153|A|Copyright(c) 2025 First Databank, Inc.||
8069|154|B|||
8071|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8071|002|Z|does NOT have all possible information about this product. This||
8071|003|Z|information does not assure that this product is safe, effective,||
8071|004|Z|or appropriate for you. This information is not individual||
8071|005|Z|medical advice and does not substitute for the advice of your||
8071|006|Z|health care professional. Always ask your health care||
8071|007|Z|professional for complete information about this product and your||
8071|008|Z|specific health needs.||
8071|009|B|||
8071|010|T|SULFASALAZINE - ORAL||
8071|011|F|(sull-fuh-SAL-uh-zeen)||
8071|012|B|||
8071|013|C|COMMON BRAND NAME(S): Azulfidine||
8071|014|B|||
8071|015|U|USES:  Sulfasalazine is used to treat a certain type of bowel||
8071|016|U|disease called ulcerative colitis. This medication does not cure||
8071|017|U|this condition, but it helps decrease symptoms such as fever,||
8071|018|U|stomach pain, diarrhea, and rectal bleeding. After an attack is||
8071|019|U|treated, sulfasalazine is also used to increase the amount of||
8071|020|U|time between attacks. This medication works by reducing||
8071|021|U|irritation and swelling in the large intestines.||
8071|022|U|   In addition, delayed-release tablets of sulfasalazine are used||
8071|023|U|to treat rheumatoid arthritis. Sulfasalazine helps to reduce||
8071|024|U|joint pain, swelling, and stiffness. Early treatment of||
8071|025|U|rheumatoid arthritis with sulfasalazine helps to reduce/prevent||
8071|026|U|further joint damage so you can do more of your normal daily||
8071|027|U|activities. This medication is used with other drugs, rest, and||
8071|028|U|physical therapy in patients who have not responded to other||
8071|029|U|medications (salicylates, nonsteroidal anti-inflammatory||
8071|030|U|drugs-NSAIDs).||
8071|031|B|||
8071|032|V|OTHER USES:  This section contains uses of this drug that are not||
8071|033|V|listed in the approved professional labeling for the drug but||
8071|034|V|that may be prescribed by your health care professional. Use this||
8071|035|V|drug for a condition that is listed in this section only if it||
8071|036|V|has been so prescribed by your health care professional.||
8071|037|V|   This drug may also be used for another type of bowel disease||
8071|038|V|called Crohn's disease.||
8071|039|B|||
8071|040|H|HOW TO USE:  Take this medication by mouth after meals with a||
8071|041|H|full glass of water (8 ounces or 240 milliliters) as directed by||
8071|042|H|your doctor. To prevent stomach upset, your doctor may recommend||
8071|043|H|a slow increase in your dosage when starting treatment. The||
8071|044|H|dosage is based on your medical condition and response to||
8071|045|H|treatment. Children's dosage is also based on weight.||
8071|046|H|   If you are taking the delayed-release tablets, swallow them||
8071|047|H|whole. Do not crush, chew, or break the tablets. Doing so may||
8071|048|H|increase the chance of stomach upset.||
8071|049|H|   Drink plenty of fluids during treatment with this medication||
8071|050|H|unless otherwise directed by your doctor. This will help prevent||
8071|051|H|kidney stones.||
8071|052|H|   Take this medication regularly to get the most benefit from||
8071|053|H|it. To help you remember, take it at the same times each day.||
8071|054|H|   Tell your doctor if your condition does not get better or if||
8071|055|H|it gets worse. For the treatment of rheumatoid arthritis, it may||
8071|056|H|take 1 to 3 months before you notice any improvement in your||
8071|057|H|symptoms.||
8071|058|B|||
8071|059|S|SIDE EFFECTS:  Stomach upset, nausea, vomiting, loss of appetite,||
8071|060|S|headache, dizziness, or unusual tiredness may occur. If any of||
8071|061|S|these effects last or get worse, tell your doctor or pharmacist||
8071|062|S|promptly.||
8071|063|S|   This medication may cause your skin and urine to turn||
8071|064|S|orange-yellow. This effect is harmless and will disappear when||
8071|065|S|the medication is stopped.||
8071|066|S|   Rarely, delayed-release tablets of sulfasalazine may appear||
8071|067|S|whole or only partly dissolved in your stool. If this occurs,||
8071|068|S|tell your doctor right away so your treatment can be changed.||
8071|069|S|   Remember that this medication has been prescribed because your||
8071|070|S|doctor has judged that the benefit to you is greater than the||
8071|071|S|risk of side effects. Many people using this medication do not||
8071|072|S|have serious side effects.||
8071|073|S|   Tell your doctor right away if you have any serious side||
8071|074|S|effects, including: hearing changes (such as ringing in the||
8071|075|S|ears), mental/mood changes, signs of kidney problems (such as||
8071|076|S|change in the amount of urine, painful urination, blood in the||
8071|077|S|urine), new lump/growth in the neck (goiter), numbness/tingling||
8071|078|S|of the hands/feet, signs of low blood sugar (such as hunger, cold||
8071|079|S|sweat, blurred vision, weakness, fast heartbeat).||
8071|080|S|   This medication may rarely cause very serious allergic||
8071|081|S|reactions (such as Stevens-Johnson syndrome), blood disorders||
8071|082|S|(such as agranulocytosis, aplastic anemia), liver damage,||
8071|083|S|nerve/muscle problems and infections. Get medical help right away||
8071|084|S|if you have any very serious side effects, including: headache||
8071|085|S|that is severe or doesn't go away, skin rash/blisters/peeling,||
8071|086|S|mouth sores, itching/swelling (especially of the||
8071|087|S|face/tongue/throat), severe dizziness, trouble breathing, chest||
8071|088|S|pain, signs of infection (such as sore throat that doesn't go||
8071|089|S|away, fever, chills), swollen lymph nodes, easy||
8071|090|S|bruising/bleeding, severe tiredness, muscle pain/weakness||
8071|091|S|(especially with fever and unusual tiredness), pale or blue||
8071|092|S|skin/lips/nails, new/worsening joint pain, confusion, unexplained||
8071|093|S|neck stiffness, seizures, signs of liver problems (such as||
8071|094|S|nausea/vomiting that doesn't stop, severe stomach/abdominal pain,||
8071|095|S|yellowing eyes/skin, dark urine).||
8071|096|S|   This is not a complete list of possible side effects. If you||
8071|097|S|notice other effects not listed above, contact your doctor or||
8071|098|S|pharmacist.||
8071|099|S|   In the US -||
8071|100|S|   Call your doctor for medical advice about side effects. You||
8071|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8071|102|S|www.fda.gov/medwatch.||
8071|103|S|   In Canada - Call your doctor for medical advice about side||
8071|104|S|effects. You may report side effects to Health Canada at||
8071|105|S|1-866-234-2345.||
8071|106|B|||
8071|107|P|PRECAUTIONS:  Before taking sulfasalazine, tell your doctor or||
8071|108|P|pharmacist if you are allergic to it; or to sulfa drugs; or to||
8071|109|P|aspirin and related drugs (salicylates, NSAIDs such as||
8071|110|P|ibuprofen); or to mesalamine; or if you have any other allergies.||
8071|111|P|This product may contain inactive ingredients, which can cause||
8071|112|P|allergic reactions or other problems. Talk to your pharmacist for||
8071|113|P|more details.||
8071|114|P|   Before using this medication, tell your doctor or pharmacist||
8071|115|P|your medical history, especially of: intestinal blockage, urinary||
8071|116|P|blockage, kidney disease, liver disease, blood disorders (such as||
8071|117|P|aplastic anemia, porphyria), a certain genetic condition (G6PD||
8071|118|P|deficiency), asthma, severe allergies, current/recent/returning||
8071|119|P|infections.||
8071|120|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8071|121|P|can make you more dizzy. Do not drive, use machinery, or do||
8071|122|P|anything that needs alertness until you can do it safely. Limit||
8071|123|P|alcoholic beverages. Talk to your doctor if you are using||
8071|124|P|marijuana (cannabis).||
8071|125|P|   This medication may make you more sensitive to the sun. Limit||
8071|126|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8071|127|P|sunscreen and wear protective clothing when outdoors. Get medical||
8071|128|P|help right away if you get sunburned or have skin||
8071|129|P|blisters/redness.||
8071|130|P|   This medication is similar to aspirin. Children and teenagers||
8071|131|P|younger than 18 years should not take aspirin or aspirin-related||
8071|132|P|medications (such as salicylates) if they have chickenpox, flu,||
8071|133|P|or any undiagnosed illness, or if they have just been given a||
8071|134|P|live virus vaccine (such as varicella vaccine), without first||
8071|135|P|consulting a doctor about Reye's syndrome, a rare but serious||
8071|136|P|illness.||
8071|137|P|   This medication can temporarily affect fertility in males. Ask||
8071|138|P|your doctor for more details.||
8071|139|P|   During pregnancy, this medication should be used only when||
8071|140|P|clearly needed. Caution is advised if this medication is used||
8071|141|P|near the expected delivery date because similar drugs may cause||
8071|142|P|harm to a newborn. Discuss the risks and benefits with your||
8071|143|P|doctor. If you become pregnant while taking this drug, contact||
8071|144|P|your doctor right away. This medication may lower your folic acid||
8071|145|P|levels, increasing the risk of spinal cord defects. Check with||
8071|146|P|your doctor to make sure you are taking enough folic acid.||
8071|147|P|Prenatal care should include tests for spinal cord defects.||
8071|148|P|   This drug passes into breast milk and could have undesirable||
8071|149|P|effects on a nursing infant. Consult your doctor before||
8071|150|P|breastfeeding.||
8071|151|B|||
8071|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8071|153|I|medications work or increase your risk for serious side effects.||
8071|154|I|This document does not contain all possible drug interactions.||
8071|155|I|Keep a list of all the products you use (including||
8071|156|I|prescription/nonprescription drugs and herbal products) and share||
8071|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
8071|158|I|the dosage of any medicines without your doctor's approval.||
8071|159|I|   Some products that may interact with this drug include:||
8071|160|I|digoxin, folic acid, methenamine, PABA taken by mouth.||
8071|161|I|   Sulfasalazine is very similar to mesalamine. Do not use||
8071|162|I|mesalamine medications taken by mouth while using sulfasalazine.||
8071|163|I|   This medication may interfere with certain lab tests (such as||
8071|164|I|urine normetanephrine levels, liver function tests), possibly||
8071|165|I|causing false test results. Make sure lab personnel and all your||
8071|166|I|doctors know you use this drug.||
8071|167|B|||
8071|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8071|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8071|170|O|poison control center right away. US residents can call||
8071|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8071|172|O|Symptoms of overdose may include: vomiting that doesn't stop,||
8071|173|O|severe stomach/abdominal pain, extreme drowsiness, seizures.||
8071|174|B|||
8071|175|N|NOTES:  Do not share this medication with others.||
8071|176|N|   Lab and/or medical tests (such as complete blood count,||
8071|177|N|liver/kidney function) should be done while you are taking this||
8071|178|N|medication. Keep all medical and lab appointments. Consult your||
8071|179|N|doctor for more details.||
8071|180|B|||
8071|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8071|182|D|remember. If it is near the time of the next dose, skip the||
8071|183|D|missed dose. Take your next dose at the regular time. Do not||
8071|184|D|double the dose to catch up.||
8071|185|B|||
8071|186|R|STORAGE:  Store at room temperature away from light and moisture.||
8071|187|R|Do not store in the bathroom. Keep all medications away from||
8071|188|R|children and pets.||
8071|189|R|   Do not flush medications down the toilet or pour them into a||
8071|190|R|drain unless instructed to do so. Properly discard this product||
8071|191|R|when it is expired or no longer needed. Consult your pharmacist||
8071|192|R|or local waste disposal company.||
8071|193|B|||
8071|194|A|Information last revised May 2025.||
8071|195|A|Copyright(c) 2025 First Databank, Inc.||
8071|196|B|||
8072|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8072|002|Z|does NOT have all possible information about this product. This||
8072|003|Z|information does not assure that this product is safe, effective,||
8072|004|Z|or appropriate for you. This information is not individual||
8072|005|Z|medical advice and does not substitute for the advice of your||
8072|006|Z|health care professional. Always ask your health care||
8072|007|Z|professional for complete information about this product and your||
8072|008|Z|specific health needs.||
8072|009|B|||
8072|010|T|NEOMYCIN/BACITRACIN/POLYMYXIN/HYDROCORTISONE OINTMENT-OPHTHALMIC||
8072|011|F|(nee-oh-MY-sin/ba-sih-TRAY-sin/paw-lee-MIX-in/hi-dro-KOR-tih-sown)||
8072|012|B|||
8072|013|C|COMMON BRAND NAME(S): Cortisporin||
8072|014|B|||
8072|015|U|USES:  This medication is used to treat or prevent bacterial eye||
8072|016|U|infections. This product contains neomycin, bacitracin, and||
8072|017|U|polymyxin, which are antibiotics that work by stopping the growth||
8072|018|U|of bacteria. It also contains hydrocortisone, which is an||
8072|019|U|anti-inflammatory corticosteroid that works by reducing swelling.||
8072|020|U|   This medication treats/prevents only bacterial eye infections.||
8072|021|U|It will not work for other types of eye infections. Unnecessary||
8072|022|U|use or overuse of any antibiotic can lead to its decreased||
8072|023|U|effectiveness.||
8072|024|B|||
8072|025|H|HOW TO USE:  Use this medication to the eye(s) as directed by||
8072|026|H|your doctor, usually every 3 or 4 hours.||
8072|027|H|   Do not wear contact lenses while you are using this medicine.||
8072|028|H|Sterilize contact lenses according to manufacturer's directions,||
8072|029|H|and check with your doctor before you begin using them again.||
8072|030|H|   To apply the eye ointment, wash your hands first. To avoid||
8072|031|H|contamination, do not touch the tube tip or let it touch your eye||
8072|032|H|or any other surface. Tilt your head back, look upward, and pull||
8072|033|H|down the lower eyelid to make a pouch. Place a 1/2 inch (1.5||
8072|034|H|centimeters) strip of ointment into the pouch by squeezing the||
8072|035|H|tube gently. Close the eye and roll the eyeball in all directions||
8072|036|H|to spread the medication. Try not to blink and do not rub the||
8072|037|H|eye. Repeat these steps for your other eye if so directed. Wipe||
8072|038|H|the tip of the ointment tube with a clean tissue to remove excess||
8072|039|H|medication before recapping it. Apply as often as directed by||
8072|040|H|your doctor.||
8072|041|H|   If you are using another kind of eye medication (such as drops||
8072|042|H|or ointments), apply the eye drops first and wait at least 5||
8072|043|H|minutes before applying this eye ointment. Use eye drops before||
8072|044|H|eye ointments to allow the eye drops to enter the eye. If you are||
8072|045|H|using another type of eye ointment, wait at least 10 minutes||
8072|046|H|after using this medication before applying it.||
8072|047|H|   Wait several minutes for your vision to clear before driving||
8072|048|H|or operating machinery.||
8072|049|H|   Use this medication regularly in order to get the most benefit||
8072|050|H|from it. To help you remember, use it at the same times each day.||
8072|051|H|Continue to use this medication for the full time prescribed,||
8072|052|H|even if symptoms disappear after a few days. Stopping the||
8072|053|H|medication too early may result in a return of the infection.||
8072|054|H|   Tell your doctor if your condition does not get better after 2||
8072|055|H|days of treatment.||
8072|056|B|||
8072|057|S|SIDE EFFECTS:  Stinging/burning of the eyes for a minute or two||
8072|058|S|or temporary blurred vision may occur . If any of these effects||
8072|059|S|last or get worse, tell your doctor or pharmacist promptly.||
8072|060|S|   Remember that this medication has been prescribed because your||
8072|061|S|doctor has judged that the benefit to you is greater than the||
8072|062|S|risk of side effects. Many people using this medication do not||
8072|063|S|have serious side effects.||
8072|064|S|   Use of this medication for prolonged/repeated periods may||
8072|065|S|result in a new fungal eye infection and may increase your risk||
8072|066|S|for other eye problems (such as glaucoma, cataracts). Do not use||
8072|067|S|this medication for longer than prescribed. Tell your doctor||
8072|068|S|right away if you notice any of the following: new or worsening||
8072|069|S|eye symptoms (such as discharge, swelling, redness), vision||
8072|070|S|problems, eye pain.||
8072|071|S|   A very serious allergic reaction to this drug is rare.||
8072|072|S|However, get medical help right away if you notice any symptoms||
8072|073|S|of a serious allergic reaction, including: rash, itching/swelling||
8072|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8072|075|S|breathing.||
8072|076|S|   This is not a complete list of possible side effects. If you||
8072|077|S|notice other effects not listed above, contact your doctor or||
8072|078|S|pharmacist.||
8072|079|S|   In the US -||
8072|080|S|   Call your doctor for medical advice about side effects. You||
8072|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8072|082|S|www.fda.gov/medwatch.||
8072|083|S|   In Canada - Call your doctor for medical advice about side||
8072|084|S|effects. You may report side effects to Health Canada at||
8072|085|S|1-866-234-2345.||
8072|086|B|||
8072|087|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
8072|088|P|pharmacist if you are allergic to neomycin, bacitracin,||
8072|089|P|polymyxin, or hydrocortisone; or to aminoglycoside antibiotics||
8072|090|P|(such as gentamicin, tobramycin); or to corticosteroids (such as||
8072|091|P|dexamethasone, prednisone); or if you have any other allergies.||
8072|092|P|This product may contain inactive ingredients, which can cause||
8072|093|P|allergic reactions or other problems. Talk to your pharmacist for||
8072|094|P|more details.||
8072|095|P|   Before using this medication, tell your doctor or pharmacist||
8072|096|P|your medical history, especially of: other eye problems (such as||
8072|097|P|glaucoma).||
8072|098|P|   After you apply this drug, your vision may become temporarily||
8072|099|P|blurred or unstable. Do not drive, use machinery, or do anything||
8072|100|P|that needs clear vision until you can do it safely.||
8072|101|P|   During pregnancy, this medication should be used only when||
8072|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
8072|103|P|   It is unknown if this drug passes into breast milk. Consult||
8072|104|P|your doctor before breastfeeding.||
8072|105|B|||
8072|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8072|107|I|medications work or increase your risk for serious side effects.||
8072|108|I|This document does not contain all possible drug interactions.||
8072|109|I|Keep a list of all the products you use (including||
8072|110|I|prescription/nonprescription drugs and herbal products) and share||
8072|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
8072|112|I|the dosage of any medicines without your doctor's approval.||
8072|113|B|||
8072|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8072|115|O|has overdosed and has serious symptoms such as passing out or||
8072|116|O|trouble breathing, call 911. Otherwise, call a poison control||
8072|117|O|center right away. US residents can call 1-800-222-1222. Canada||
8072|118|O|residents can call 1-844-764-7669.||
8072|119|B|||
8072|120|N|NOTES:  Do not share this medication with others.||
8072|121|N|   This medication has been prescribed for your current condition||
8072|122|N|only. Throw away the unused medication after treatment is||
8072|123|N|completed. Do not use it later for another infection unless your||
8072|124|N|doctor tells you to.||
8072|125|N|   If you are using this medication for 10 days or more, lab||
8072|126|N|and/or medical tests (such as eye exams) should be done while you||
8072|127|N|are using this medication. Keep all medical and lab appointments.||
8072|128|N|Consult your doctor for more details.||
8072|129|B|||
8072|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8072|131|D|If it is near the time of the next dose, skip the missed dose.||
8072|132|D|Use your next dose at the regular time. Do not double the dose to||
8072|133|D|catch up.||
8072|134|B|||
8072|135|R|STORAGE:  Store at room temperature. Keep all medications away||
8072|136|R|from children and pets.||
8072|137|R|   Do not flush medications down the toilet or pour them into a||
8072|138|R|drain unless instructed to do so. Properly discard this product||
8072|139|R|when it is expired or no longer needed. Consult your pharmacist||
8072|140|R|or local waste disposal company.||
8072|141|B|||
8072|142|A|Information last revised November 2024.||
8072|143|A|Copyright(c) 2025 First Databank, Inc.||
8072|144|B|||
8073|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8073|002|Z|does NOT have all possible information about this product. This||
8073|003|Z|information does not assure that this product is safe, effective,||
8073|004|Z|or appropriate for you. This information is not individual||
8073|005|Z|medical advice and does not substitute for the advice of your||
8073|006|Z|health care professional. Always ask your health care||
8073|007|Z|professional for complete information about this product and your||
8073|008|Z|specific health needs.||
8073|009|B|||
8073|010|T|MINOCYCLINE - ORAL||
8073|011|F|(MIN-oh-SYE-kleen)||
8073|012|B|||
8073|013|C|COMMON BRAND NAME(S): Dynacin, Minocin||
8073|014|B|||
8073|015|U|USES:  Minocycline is used to treat a wide variety of infections.||
8073|016|U|It may also be used along with other medications to treat severe||
8073|017|U|acne. This medication belongs to a class of drugs known as||
8073|018|U|tetracycline antibiotics. It works by stopping the growth of||
8073|019|U|bacteria.||
8073|020|U|   This antibiotic treats only bacterial infections. It will not||
8073|021|U|work for viral infections (such as common cold, flu). Using any||
8073|022|U|antibiotic when it is not needed can cause it to not work for||
8073|023|U|future infections.||
8073|024|B|||
8073|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8073|026|H|from your pharmacist before you start taking minocycline and each||
8073|027|H|time you get a refill. If you have any questions, ask your doctor||
8073|028|H|or pharmacist.||
8073|029|H|   Take this medication by mouth on an empty stomach (at least 1||
8073|030|H|hour before or 2 hours after a meal) as directed by your doctor,||
8073|031|H|usually every 12 hours. Take this medication with a full glass of||
8073|032|H|water (8 ounces/240 milliliters) unless your doctor directs you||
8073|033|H|otherwise. If stomach upset occurs, taking it with food or milk||
8073|034|H|may help. However, minocycline may not work as well if you take||
8073|035|H|it with food or milk, so ask your doctor or pharmacist if you may||
8073|036|H|take it that way. If you are taking the capsules, swallow them||
8073|037|H|whole. Do not lie down for at least 10 minutes after taking this||
8073|038|H|medication. For this reason, do not take it right before bedtime.||
8073|039|H|   Take this medication 2 to 3 hours before or after taking any||
8073|040|H|products containing aluminum, calcium, iron, magnesium, zinc, or||
8073|041|H|bismuth subsalicylate. Some examples include antacids, quinapril,||
8073|042|H|sucralfate, vitamins/minerals, dairy products (such as milk,||
8073|043|H|yogurt), and juice with added calcium. These products bind with||
8073|044|H|minocycline, preventing your body from fully absorbing the drug.||
8073|045|H|   The dosage and length of treatment are based on your medical||
8073|046|H|condition and response to treatment.||
8073|047|H|   For the best effect, take this antibiotic at evenly spaced||
8073|048|H|times. To help you remember, take this medication at the same||
8073|049|H|times every day.||
8073|050|H|   Continue to take this medication until the full prescribed||
8073|051|H|amount is finished, even if symptoms disappear after a few days.||
8073|052|H|Stopping the medication too early may result in a return of the||
8073|053|H|infection.||
8073|054|H|   Tell your doctor if your condition lasts or gets worse.||
8073|055|B|||
8073|056|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, lightheadedness,||
8073|057|S|dizziness, or a feeling of spinning may occur. If any of these||
8073|058|S|effects last or get worse, tell your doctor or pharmacist||
8073|059|S|promptly.||
8073|060|S|   Remember that this medication has been prescribed because your||
8073|061|S|doctor has judged that the benefit to you is greater than the||
8073|062|S|risk of side effects. Many people using this medication do not||
8073|063|S|have serious side effects.||
8073|064|S|   Tell your doctor right away if you have any serious side||
8073|065|S|effects, including: painful/difficult swallowing, hearing changes||
8073|066|S|(such as ringing in the ears, decreased hearing), joint||
8073|067|S|stiffness/pain/swelling, signs of kidney problems (such as change||
8073|068|S|in the amount of urine, pink urine), signs of liver problems||
8073|069|S|(such as loss of appetite, stomach/abdominal pain, yellowing||
8073|070|S|eyes/skin, dark urine), yellow-gray-brown tooth discoloration,||
8073|071|S|blue-gray skin/tongue/lips/gums.||
8073|072|S|   Minocycline may rarely cause increased pressure around the||
8073|073|S|brain (intracranial hypertension-IH). The risk of this side||
8073|074|S|effect is greater for women of childbearing age who are||
8073|075|S|overweight or who have had IH in the past. If IH develops, it||
8073|076|S|usually goes away after minocycline is stopped; however, there is||
8073|077|S|a chance of permanent vision loss or blindness. Get medical help||
8073|078|S|right away if you have: severe/lasting headache, vision changes||
8073|079|S|(such as blurred/double vision, decreased vision, sudden||
8073|080|S|blindness), nausea/vomiting that doesn't stop.||
8073|081|S|   This medication may rarely cause a severe intestinal condition||
8073|082|S|due to a bacteria called C. difficile. This condition may occur||
8073|083|S|during treatment or weeks to months after treatment has stopped.||
8073|084|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8073|085|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8073|086|S|stool.||
8073|087|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8073|088|S|products because they may make symptoms worse.||
8073|089|S|   Use of this medication for prolonged or repeated periods may||
8073|090|S|result in oral thrush or a new yeast infection. Contact your||
8073|091|S|doctor if you notice white patches in your mouth, a change in||
8073|092|S|vaginal discharge, or other new symptoms.||
8073|093|S|   A very serious allergic reaction to this drug is rare.||
8073|094|S|However, get medical help right away if you notice any symptoms||
8073|095|S|of a serious allergic reaction, including: fever that doesn't go||
8073|096|S|away, new or worsening lymph node swelling, rash,||
8073|097|S|itching/swelling (especially of the face/tongue/throat), severe||
8073|098|S|dizziness, trouble breathing.||
8073|099|S|   This is not a complete list of possible side effects. If you||
8073|100|S|notice other effects not listed above, contact your doctor or||
8073|101|S|pharmacist.||
8073|102|S|   In the US -||
8073|103|S|   Call your doctor for medical advice about side effects. You||
8073|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8073|105|S|www.fda.gov/medwatch.||
8073|106|S|   In Canada - Call your doctor for medical advice about side||
8073|107|S|effects. You may report side effects to Health Canada at||
8073|108|S|1-866-234-2345.||
8073|109|B|||
8073|110|P|PRECAUTIONS:  See also Side Effects section.||
8073|111|P|   Before taking minocycline, tell your doctor or pharmacist if||
8073|112|P|you are allergic to it; or to other tetracyclines (such as||
8073|113|P|doxycycline); or if you have any other allergies. This product||
8073|114|P|may contain inactive ingredients, which can cause allergic||
8073|115|P|reactions or other problems. Talk to your pharmacist for more||
8073|116|P|details.||
8073|117|P|   Before using this medication, tell your doctor or pharmacist||
8073|118|P|your medical history, especially of: kidney problems, liver||
8073|119|P|problems, trouble swallowing, esophagus problems (such as hiatal||
8073|120|P|hernia or reflux/heartburn).||
8073|121|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8073|122|P|can make you more dizzy. Do not drive, use machinery, or do||
8073|123|P|anything that needs alertness until you can do it safely. Limit||
8073|124|P|alcoholic beverages. Talk to your doctor if you are using||
8073|125|P|marijuana (cannabis).||
8073|126|P|   This medication may make you more sensitive to the sun. Limit||
8073|127|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8073|128|P|sunscreen and wear protective clothing when outdoors. Tell your||
8073|129|P|doctor right away if you get sunburned or have skin||
8073|130|P|blisters/redness.||
8073|131|P|   Minocycline may cause live bacterial vaccines (such as typhoid||
8073|132|P|vaccine) to not work well. Tell your health care professional||
8073|133|P|that you are using minocycline before having any||
8073|134|P|immunizations/vaccinations.||
8073|135|P|   Before having surgery, tell your doctor or dentist about all||
8073|136|P|the products you use (including prescription drugs,||
8073|137|P|nonprescription drugs, and herbal products).||
8073|138|P|   Children younger than 8 years may be more sensitive to the||
8073|139|P|side effects of minocycline, especially tooth discoloration.||
8073|140|P|Tooth discoloration has also occurred in older children and in||
8073|141|P|young adults. Discuss the risks and benefits of this medication||
8073|142|P|with the doctor.||
8073|143|P|   Tell your doctor if you are pregnant or plan to become||
8073|144|P|pregnant. You should not become pregnant while using minocycline.||
8073|145|P|Minocycline may harm an unborn baby. If you become pregnant, talk||
8073|146|P|to your doctor right away about the risks and benefits of this||
8073|147|P|medication.||
8073|148|P|   This medication passes into breast milk. Consult your doctor||
8073|149|P|before breastfeeding.||
8073|150|B|||
8073|151|I|DRUG INTERACTIONS:  See also How to Use section.||
8073|152|I|   Drug interactions may change how your medications work or||
8073|153|I|increase your risk for serious side effects. This document does||
8073|154|I|not contain all possible drug interactions. Keep a list of all||
8073|155|I|the products you use (including prescription/nonprescription||
8073|156|I|drugs and herbal products) and share it with your doctor and||
8073|157|I|pharmacist. Do not start, stop, or change the dosage of any||
8073|158|I|medicines without your doctor's approval.||
8073|159|I|   Some products that may interact with this drug are: retinoid||
8073|160|I|medications taken by mouth (such as acitretin, isotretinoin),||
8073|161|I|strontium.||
8073|162|I|   This medication may interfere with certain lab tests (such as||
8073|163|I|urine catecholamine levels), possibly causing false test results.||
8073|164|I|Make sure lab personnel and all your doctors know you use this||
8073|165|I|drug.||
8073|166|B|||
8073|167|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8073|168|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8073|169|O|poison control center right away. US residents can call||
8073|170|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8073|171|B|||
8073|172|N|NOTES:  Do not share this medication with others.||
8073|173|N|   This medication has been prescribed for your current condition||
8073|174|N|only. Do not use it later for another infection unless your||
8073|175|N|doctor tells you to.||
8073|176|N|   If you are taking this medication for a longer time, lab||
8073|177|N|and/or medical tests (such as complete blood count, kidney/liver||
8073|178|N|function) may be done while you are taking this medication. Keep||
8073|179|N|all medical and lab appointments.||
8073|180|B|||
8073|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8073|182|D|remember. If it is near the time of the next dose, skip the||
8073|183|D|missed dose. Take your next dose at the regular time. Do not||
8073|184|D|double the dose to catch up.||
8073|185|B|||
8073|186|R|STORAGE:  Store at room temperature away from light and moisture.||
8073|187|R|Do not store in the bathroom. Keep all medications away from||
8073|188|R|children and pets.||
8073|189|R|   Do not flush medications down the toilet or pour them into a||
8073|190|R|drain unless instructed to do so. Properly discard this product||
8073|191|R|when it is expired or no longer needed. Taking expired||
8073|192|R|minocycline can cause serious illness. Consult your pharmacist or||
8073|193|R|local waste disposal company.||
8073|194|B|||
8073|195|A|Information last revised September 2025.||
8073|196|A|Copyright(c) 2025 First Databank, Inc.||
8073|197|B|||
8075|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8075|002|Z|does NOT have all possible information about this product. This||
8075|003|Z|information does not assure that this product is safe, effective,||
8075|004|Z|or appropriate for you. This information is not individual||
8075|005|Z|medical advice and does not substitute for the advice of your||
8075|006|Z|health care professional. Always ask your health care||
8075|007|Z|professional for complete information about this product and your||
8075|008|Z|specific health needs.||
8075|009|B|||
8075|010|T|BENAZEPRIL - ORAL||
8075|011|F|(ben-AZ-e-pril)||
8075|012|B|||
8075|013|C|COMMON BRAND NAME(S): Lotensin||
8075|014|B|||
8075|015|W|WARNING:  This drug can cause serious harm (possibly fatal) to an||
8075|016|W|unborn baby if used during pregnancy. It is important to prevent||
8075|017|W|pregnancy while taking this medication. Consult your doctor for||
8075|018|W|more details and to discuss the use of reliable forms of birth||
8075|019|W|control while taking this medication. If you are planning||
8075|020|W|pregnancy, become pregnant or think you may be pregnant, contact||
8075|021|W|your doctor right away.||
8075|022|B|||
8075|023|U|USES:  Benazepril is used to treat high blood pressure||
8075|024|U|(hypertension). Lowering high blood pressure helps prevent||
8075|025|U|strokes, heart attacks, and kidney problems. Benazepril is an ACE||
8075|026|U|inhibitor and works by relaxing blood vessels so that blood can||
8075|027|U|flow more easily.||
8075|028|B|||
8075|029|V|OTHER USES:  This section contains uses of this drug that are not||
8075|030|V|listed in the approved professional labeling for the drug but||
8075|031|V|that may be prescribed by your health care professional. Use this||
8075|032|V|drug for a condition that is listed in this section only if it||
8075|033|V|has been so prescribed by your health care professional.||
8075|034|V|   This drug may also be used for heart failure. It may also be||
8075|035|V|used for kidney disease and to help protect the kidneys from harm||
8075|036|V|due to diabetes.||
8075|037|B|||
8075|038|H|HOW TO USE:  Take this medication by mouth with or without food||
8075|039|H|as directed by your doctor, usually once or twice daily.||
8075|040|H|   If you are using the suspension form of this medication, shake||
8075|041|H|the bottle well before each dose. Carefully measure the dose||
8075|042|H|using a special measuring device/spoon. Do not use a household||
8075|043|H|spoon because you may not get the correct dose.||
8075|044|H|   The dosage is based on your medical condition and response to||
8075|045|H|treatment. Children's dosage is also based on weight.||
8075|046|H|   Use this medication regularly in order to get the most benefit||
8075|047|H|from it. To help you remember, take it at the same time(s) each||
8075|048|H|day. Keep taking this medication even if you feel well. Most||
8075|049|H|people with high blood pressure do not feel sick.||
8075|050|H|   It may take 1 to 2 weeks before you get the full benefit of||
8075|051|H|this medication. Tell your doctor if your condition does not get||
8075|052|H|better or if it gets worse (your blood pressure readings remain||
8075|053|H|high or increase).||
8075|054|B|||
8075|055|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, or||
8075|056|S|headache may occur as your body adjusts to the medication. Dry||
8075|057|S|cough may also occur. If any of these effects last or get worse,||
8075|058|S|tell your doctor or pharmacist promptly.||
8075|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
8075|060|S|slowly when rising from a sitting or lying position.||
8075|061|S|   Remember that this medication has been prescribed because your||
8075|062|S|doctor has judged that the benefit to you is greater than the||
8075|063|S|risk of side effects. Many people using this medication do not||
8075|064|S|have serious side effects.||
8075|065|S|   Tell your doctor right away if you have any serious side||
8075|066|S|effects, including: fainting, symptoms of a high potassium blood||
8075|067|S|level (such as muscle weakness, slow/irregular heartbeat).||
8075|068|S|   Although benazepril may be used to prevent kidney problems or||
8075|069|S|treat people who have kidney problems, it may also rarely cause||
8075|070|S|serious kidney problems or make them worse. Your doctor will||
8075|071|S|check your kidney function while you are taking benazepril. Tell||
8075|072|S|your doctor right away if you have any signs of kidney problems||
8075|073|S|such as a change in the amount of urine.||
8075|074|S|   This drug may rarely cause serious (possibly fatal) liver||
8075|075|S|problems. Get medical help right away if you have any symptoms of||
8075|076|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
8075|077|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
8075|078|S|urine.||
8075|079|S|   A very serious allergic reaction to this drug is rare.||
8075|080|S|However, get medical help right away if you notice any symptoms||
8075|081|S|of a serious allergic reaction, including: rash, itching/swelling||
8075|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8075|083|S|breathing.||
8075|084|S|   This is not a complete list of possible side effects. If you||
8075|085|S|notice other effects not listed above, contact your doctor or||
8075|086|S|pharmacist.||
8075|087|S|   In the US -||
8075|088|S|   Call your doctor for medical advice about side effects. You||
8075|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8075|090|S|www.fda.gov/medwatch.||
8075|091|S|   In Canada - Call your doctor for medical advice about side||
8075|092|S|effects. You may report side effects to Health Canada at||
8075|093|S|1-866-234-2345.||
8075|094|B|||
8075|095|P|PRECAUTIONS:  Before taking benazepril, tell your doctor or||
8075|096|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
8075|097|P|(such as lisinopril); or if you have any other allergies. This||
8075|098|P|product may contain inactive ingredients, which can cause||
8075|099|P|allergic reactions or other problems. Talk to your pharmacist for||
8075|100|P|more details.||
8075|101|P|   Before using this medication, tell your doctor or pharmacist||
8075|102|P|your medical history, especially of: history of an allergic||
8075|103|P|reaction which included swelling of the face/lips/tongue/throat||
8075|104|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
8075|105|P|dialysis), high level of potassium in the blood.||
8075|106|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8075|107|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8075|108|P|machinery, or do anything that needs alertness until you can do||
8075|109|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8075|110|P|are using marijuana (cannabis).||
8075|111|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
8075|112|P|and cause you to feel lightheaded. Tell your doctor if you have||
8075|113|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
8075|114|P|of fluids unless your doctor tells you not to.||
8075|115|P|   Before having surgery, tell your doctor or dentist about all||
8075|116|P|the products you use (including prescription drugs,||
8075|117|P|nonprescription drugs, and herbal products).||
8075|118|P|   This product may increase your potassium levels. Before using||
8075|119|P|potassium supplements or salt substitutes that contain potassium,||
8075|120|P|consult your doctor or pharmacist.||
8075|121|P|   Older adults may be more sensitive to the side effects of this||
8075|122|P|drug, including dizziness and increases in potassium level.||
8075|123|P|   Tell your doctor if you are pregnant or plan to become||
8075|124|P|pregnant. You should not become pregnant while using benazepril.||
8075|125|P|Benazepril may harm an unborn baby. If you become pregnant, talk||
8075|126|P|to your doctor right away about the risks and benefits of this||
8075|127|P|medication. See also Warning section.||
8075|128|P|   This medication passes into breast milk. Consult your doctor||
8075|129|P|before breastfeeding.||
8075|130|B|||
8075|131|I|DRUG INTERACTIONS:  See also Precautions section.||
8075|132|I|   Drug interactions may change how your medications work or||
8075|133|I|increase your risk for serious side effects. This document does||
8075|134|I|not contain all possible drug interactions. Keep a list of all||
8075|135|I|the products you use (including prescription/nonprescription||
8075|136|I|drugs and herbal products) and share it with your doctor and||
8075|137|I|pharmacist. Do not start, stop, or change the dosage of any||
8075|138|I|medicines without your doctor's approval.||
8075|139|I|   Some products that may interact with this drug include:||
8075|140|I|aliskiren, certain drugs that weaken the immune system/increase||
8075|141|I|the risk of infection (such as everolimus, sirolimus), lithium,||
8075|142|I|drugs that may increase the level of potassium in the blood (such||
8075|143|I|as ARBs including losartan/valsartan, birth control pills||
8075|144|I|containing drospirenone), sacubitril.||
8075|145|I|   Some products have ingredients that could raise your blood||
8075|146|I|pressure or worsen your heart failure. Tell your pharmacist what||
8075|147|I|products you are using, and ask how to use them safely||
8075|148|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
8075|149|I|ibuprofen/naproxen).||
8075|150|I|   A very serious reaction may occur if you are getting||
8075|151|I|injections for bee/wasp sting allergy (desensitization) and are||
8075|152|I|also taking benazepril. Make sure all your doctors know which||
8075|153|I|medicines you are using.||
8075|154|B|||
8075|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8075|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8075|157|O|poison control center right away. US residents can call||
8075|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8075|159|O|Symptoms of overdose may include: severe dizziness, fainting.||
8075|160|B|||
8075|161|N|NOTES:  Do not share this medication with others.||
8075|162|N|   Lifestyle changes such as stress reduction programs, exercise||
8075|163|N|and dietary changes may increase the effectiveness of this||
8075|164|N|medicine. Talk to your doctor or pharmacist about lifestyle||
8075|165|N|changes that might benefit you.||
8075|166|N|   Lab and/or medical tests (such as kidney function, potassium||
8075|167|N|levels) should be done while you are taking this medication. Keep||
8075|168|N|all medical and lab appointments. Consult your doctor for more||
8075|169|N|details.||
8075|170|N|   Check your blood pressure regularly while taking this||
8075|171|N|medication. Learn how to monitor your own blood pressure at home,||
8075|172|N|and share the results with your doctor.||
8075|173|B|||
8075|174|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8075|175|D|remember. If it is near the time of the next dose, skip the||
8075|176|D|missed dose. Take your next dose at the regular time. Do not||
8075|177|D|double the dose to catch up.||
8075|178|B|||
8075|179|R|STORAGE:  Store tablets at room temperature away from light and||
8075|180|R|moisture. Store the suspension in the refrigerator. Discard any||
8075|181|R|unused suspension after 30 days. Do not store in the bathroom.||
8075|182|R|Keep all medications away from children and pets.||
8075|183|R|   Do not flush medications down the toilet or pour them into a||
8075|184|R|drain unless instructed to do so. Properly discard this product||
8075|185|R|when it is expired or no longer needed. Consult your pharmacist||
8075|186|R|or local waste disposal company.||
8075|187|B|||
8075|188|A|Information last revised August 2024.||
8075|189|A|Copyright(c) 2025 First Databank, Inc.||
8075|190|B|||
8077|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8077|002|Z|does NOT have all possible information about this product. This||
8077|003|Z|information does not assure that this product is safe, effective,||
8077|004|Z|or appropriate for you. This information is not individual||
8077|005|Z|medical advice and does not substitute for the advice of your||
8077|006|Z|health care professional. Always ask your health care||
8077|007|Z|professional for complete information about this product and your||
8077|008|Z|specific health needs.||
8077|009|B|||
8077|010|T|NICOTINE SPRAY - NASAL||
8077|011|F|(NICK-oh-teen)||
8077|012|B|||
8077|013|C|COMMON BRAND NAME(S): Nicotrol NS||
8077|014|B|||
8077|015|U|USES:  This medication can help you quit smoking by replacing the||
8077|016|U|nicotine in cigarettes. The nicotine in tobacco is an important||
8077|017|U|part of cigarette addiction. When you stop smoking, your nicotine||
8077|018|U|levels drop quickly. This drop can cause withdrawal symptoms such||
8077|019|U|as craving tobacco, nervousness, irritability, headache, weight||
8077|020|U|gain, and difficulty concentrating.||
8077|021|U|   Stopping smoking is hard and your chance of success is best||
8077|022|U|when you are ready and have made a commitment to quit. Nicotine||
8077|023|U|replacement products are part of a total stop-smoking program||
8077|024|U|that includes behavior change, counseling, and support. Smoking||
8077|025|U|causes lung disease, cancer, and heart disease. Stopping smoking||
8077|026|U|is one of the most important things you can do to improve your||
8077|027|U|health and live longer.||
8077|028|B|||
8077|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8077|030|H|from your pharmacist before you start using your nicotine nasal||
8077|031|H|spray and each time you get a refill. Follow all the directions||
8077|032|H|for use carefully. If you have any questions, ask your doctor or||
8077|033|H|pharmacist.||
8077|034|H|   It is very important to stop smoking completely while using||
8077|035|H|this nicotine product. Tilt your head back and use 1 spray in||
8077|036|H|each nostril or as directed by your doctor. Do not sniff,||
8077|037|H|swallow, or inhale through the nose as you use the spray. Follow||
8077|038|H|all instructions and learn proper technique for use.||
8077|039|H|   When you quit smoking, start using your nicotine nasal spray||
8077|040|H|whenever you crave a cigarette, using 2 to 4 sprays per hour.||
8077|041|H|Usually, you will use at least 8 doses (16 sprays) each day when||
8077|042|H|you first start or as directed by your doctor. Do not use more||
8077|043|H|than 40 doses total (80 sprays) in a day. Your doctor may direct||
8077|044|H|you to use this product on a regular schedule as well as at times||
8077|045|H|when you have the urge to smoke. Regular use during the first||
8077|046|H|week can help your body get used to the medication and decrease||
8077|047|H|side effects such as nose irritation. The best dose for you is||
8077|048|H|the dose that decreases the urge to smoke without side effects||
8077|049|H|from too much nicotine. Follow your doctor's orders carefully.||
8077|050|H|Your dose will need to be adjusted to your needs, including||
8077|051|H|smoking history and medical condition.||
8077|052|H|   If this drug touches the skin, lips, mouth, or ears, rinse the||
8077|053|H|affected area right away with water. Do not use soap. If this||
8077|054|H|medication gets into your eyes, flush your eyes with clear water||
8077|055|H|for 20 minutes. Discard used containers with the child-resistant||
8077|056|H|cap on and away from the reach of children and pets.||
8077|057|H|   After you have stopped smoking and you have reached the best||
8077|058|H|dose and schedule for you, continue at that dose. Usually, after||
8077|059|H|about 8 weeks, your doctor will help you gradually reduce your||
8077|060|H|dose until you are no longer smoking and no longer need nicotine||
8077|061|H|replacement. Treatment for longer than 6 months is usually not||
8077|062|H|recommended, but consult your doctor.||
8077|063|H|   If you suddenly stop using this medication, you may have||
8077|064|H|withdrawal symptoms (such as tobacco cravings, nervousness,||
8077|065|H|irritability, headache). To help prevent withdrawal, your doctor||
8077|066|H|may lower your dose slowly. Withdrawal is more likely if you have||
8077|067|H|used nicotine for a long time or in high doses. Tell your doctor||
8077|068|H|or pharmacist right away if you have withdrawal.||
8077|069|H|   Tell your doctor if you have not been able to quit smoking||
8077|070|H|after using this product for 4 weeks. Some smokers are||
8077|071|H|unsuccessful the first time they try to quit. You may need to||
8077|072|H|stop using this product and try again later. Many people who||
8077|073|H|cannot quit the first time are successful the next time.||
8077|074|B|||
8077|075|S|SIDE EFFECTS:  Nasal irritation/blistering/tingling, runny or||
8077|076|S|bloody nose, throat irritation, watering eyes, sneezing, cough,||
8077|077|S|heartburn, or a change in taste or smell may occur. Common||
8077|078|S|nicotine withdrawal symptoms can occur when you stop smoking and||
8077|079|S|include: dizziness, anxiety, depression, or trouble sleeping,||
8077|080|S|among others. If any of these withdrawal symptoms or side effects||
8077|081|S|last or get worse, tell your doctor or pharmacist promptly.||
8077|082|S|   Remember that this medication has been prescribed because your||
8077|083|S|doctor has judged that the benefit to you is greater than the||
8077|084|S|risk of side effects. Many people using this medication do not||
8077|085|S|have serious side effects. Serious side effects are more likely||
8077|086|S|if you continue to smoke while using this product. Do not smoke||
8077|087|S|while you are using this medication.||
8077|088|S|   Stop using this medication and tell your doctor right away if||
8077|089|S|you have any serious side effects, including: dizziness,||
8077|090|S|mental/mood changes (such as irritability, trouble sleeping,||
8077|091|S|vivid dreams), numbness/tingling in hands/feet, swelling||
8077|092|S|hands/ankles/feet.||
8077|093|S|   Stop using this medication and get medical help right away if||
8077|094|S|you have any very serious side effects, including: chest pain,||
8077|095|S|confusion, severe headache, fast/irregular/pounding heartbeat,||
8077|096|S|trouble speaking, weakness on one side of the body.||
8077|097|S|   A very serious allergic reaction to this drug is rare.||
8077|098|S|However, get medical help right away if you notice any symptoms||
8077|099|S|of a serious allergic reaction, including: rash, itching/swelling||
8077|100|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8077|101|S|breathing.||
8077|102|S|   This is not a complete list of possible side effects. If you||
8077|103|S|notice other effects not listed above, contact your doctor or||
8077|104|S|pharmacist.||
8077|105|S|   In the US -||
8077|106|S|   Call your doctor for medical advice about side effects. You||
8077|107|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8077|108|S|www.fda.gov/medwatch.||
8077|109|S|   In Canada - Call your doctor for medical advice about side||
8077|110|S|effects. You may report side effects to Health Canada at||
8077|111|S|1-866-234-2345.||
8077|112|B|||
8077|113|P|PRECAUTIONS:  Before using this product, tell your doctor or||
8077|114|P|pharmacist if you are allergic to it; or if you have any other||
8077|115|P|allergies. This product may contain inactive ingredients, which||
8077|116|P|can cause allergic reactions or other problems. Talk to your||
8077|117|P|pharmacist for more details.||
8077|118|P|   Before using this medication, tell your doctor or pharmacist||
8077|119|P|your medical history, especially of: blood vessel disease (such||
8077|120|P|as Raynaud's disease, stroke), breathing problems (such as||
8077|121|P|asthma, emphysema), diabetes, heart disease (such as chest pain,||
8077|122|P|heart attack, irregular heartbeat), high blood pressure, liver||
8077|123|P|disease, kidney disease, esophagus problems (such as||
8077|124|P|esophagitis), chronic nasal disorders (such as nasal allergies,||
8077|125|P|nasal polyps, sinusitis), stomach/intestinal sores (peptic||
8077|126|P|ulcers), a certain adrenal gland tumor (pheochromocytoma),||
8077|127|P|overactive thyroid (hyperthyroidism), seizures.||
8077|128|P|   Before having surgery, tell your doctor or dentist about all||
8077|129|P|the products you use (including prescription drugs,||
8077|130|P|nonprescription drugs, and herbal products).||
8077|131|P|   Nicotine and smoking may harm an unborn baby. If you are||
8077|132|P|pregnant, try to stop smoking without using a nicotine||
8077|133|P|replacement product if possible. During pregnancy, this||
8077|134|P|medication should be used only when clearly needed. Discuss the||
8077|135|P|risks and benefits with your doctor.||
8077|136|P|   Nicotine from smoking and from this medication passes into||
8077|137|P|breast milk and could have undesirable effects on a nursing||
8077|138|P|infant. Smoking near an infant can also harm the infant. Consult||
8077|139|P|your doctor before breastfeeding.||
8077|140|B|||
8077|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8077|142|I|medications work or increase your risk for serious side effects.||
8077|143|I|This document does not contain all possible drug interactions.||
8077|144|I|Keep a list of all the products you use (including||
8077|145|I|prescription/nonprescription drugs and herbal products) and share||
8077|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
8077|147|I|the dosage of any medicines without your doctor's approval.||
8077|148|I|   Stopping smoking can change the way the liver removes certain||
8077|149|I|drugs from the body (including acetaminophen, caffeine, insulin,||
8077|150|I|oxazepam, pentazocine, propoxyphene, propranolol, theophylline,||
8077|151|I|tricyclic antidepressants such as amitriptyline/imipramine,||
8077|152|I|"water pills"/diuretics such as furosemide). Tell all your||
8077|153|I|doctors and pharmacists that you are quitting smoking.||
8077|154|B|||
8077|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8077|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8077|157|O|poison control center right away. US residents can call||
8077|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8077|159|O|Symptoms of overdose may include: confusion, drooling, seizure,||
8077|160|O|slow/shallow breathing, hearing problems.||
8077|161|B|||
8077|162|N|NOTES:  Do not share this medication with others.||
8077|163|B|||
8077|164|D|MISSED DOSE:  If you are using this on a regular schedule and you||
8077|165|D|miss a dose, use it as soon as you remember. If it is near the||
8077|166|D|time of the next dose, skip the missed dose. Use your next dose||
8077|167|D|at the regular time. Do not double the dose to catch up.||
8077|168|B|||
8077|169|R|STORAGE:  Store at room temperature. Keep all medications away||
8077|170|R|from children and pets.||
8077|171|R|   Do not flush medications down the toilet or pour them into a||
8077|172|R|drain unless instructed to do so. Properly discard this product||
8077|173|R|when it is expired or no longer needed. Consult your pharmacist||
8077|174|R|or local waste disposal company.||
8077|175|B|||
8077|176|A|Information last revised January 2025.||
8077|177|A|Copyright(c) 2025 First Databank, Inc.||
8077|178|B|||
8078|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8078|002|Z|does NOT have all possible information about this product. This||
8078|003|Z|information does not assure that this product is safe, effective,||
8078|004|Z|or appropriate for you. This information is not individual||
8078|005|Z|medical advice and does not substitute for the advice of your||
8078|006|Z|health care professional. Always ask your health care||
8078|007|Z|professional for complete information about this product and your||
8078|008|Z|specific health needs.||
8078|009|B|||
8078|010|T|EPLERENONE - ORAL||
8078|011|F|(eh-PLER-en-own)||
8078|012|B|||
8078|013|C|COMMON BRAND NAME(S): Inspra||
8078|014|B|||
8078|015|U|USES:  This medication is used alone or in combination with other||
8078|016|U|medicines to treat high blood pressure. It works by blocking a||
8078|017|U|chemical (aldosterone) in your body which in turn lowers the||
8078|018|U|amount of sodium and water the body retains. Lowering high blood||
8078|019|U|pressure helps prevent strokes, heart attacks and kidney||
8078|020|U|problems. It is also used to treat heart failure following a||
8078|021|U|heart attack.||
8078|022|B|||
8078|023|H|HOW TO USE:  Take this medication by mouth with or without food||
8078|024|H|as directed by your doctor, usually once or twice daily.||
8078|025|H|   The dosage is based on your medical condition, response to||
8078|026|H|treatment, and other medications you may be taking. Be sure to||
8078|027|H|tell your doctor and pharmacist about all the products you use||
8078|028|H|(including prescription drugs, nonprescription drugs, and herbal||
8078|029|H|products).||
8078|030|H|   Use this medication regularly to get the most benefit from it.||
8078|031|H|To help you remember, take it at the same time(s) each day. Keep||
8078|032|H|taking this medication even if you feel well. Most people with||
8078|033|H|high blood pressure do not feel sick.||
8078|034|H|   It may take up to 4 weeks for this medication to fully affect||
8078|035|H|your blood pressure.||
8078|036|H|   Tell your doctor if your condition does not get better or if||
8078|037|H|it gets worse (for example, your blood pressure readings remain||
8078|038|H|high or increase).||
8078|039|B|||
8078|040|S|SIDE EFFECTS:  Headache, dizziness, diarrhea, or vomiting may||
8078|041|S|occur. If any of these effects last or get worse, tell your||
8078|042|S|doctor or pharmacist promptly.||
8078|043|S|   Remember that this medication has been prescribed because your||
8078|044|S|doctor has judged that the benefit to you is greater than the||
8078|045|S|risk of side effects. Many people using this medication do not||
8078|046|S|have serious side effects.||
8078|047|S|   Tell your doctor right away if you have any serious side||
8078|048|S|effects, including: abnormal vaginal bleeding, enlarged or sore||
8078|049|S|breasts in males, symptoms of a high potassium blood level (such||
8078|050|S|as muscle weakness, slow/irregular heartbeat).||
8078|051|S|   A very serious allergic reaction to this drug is rare.||
8078|052|S|However, get medical help right away if you notice any symptoms||
8078|053|S|of a serious allergic reaction, including: rash, itching/swelling||
8078|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8078|055|S|breathing.||
8078|056|S|   This is not a complete list of possible side effects. If you||
8078|057|S|notice other effects not listed above, contact your doctor or||
8078|058|S|pharmacist.||
8078|059|S|   In the US -||
8078|060|S|   Call your doctor for medical advice about side effects. You||
8078|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8078|062|S|www.fda.gov/medwatch.||
8078|063|S|   In Canada - Call your doctor for medical advice about side||
8078|064|S|effects. You may report side effects to Health Canada at||
8078|065|S|1-866-234-2345.||
8078|066|B|||
8078|067|P|PRECAUTIONS:  Before taking eplerenone, tell your doctor or||
8078|068|P|pharmacist if you are allergic to it; or if you have any other||
8078|069|P|allergies. This product may contain inactive ingredients, which||
8078|070|P|can cause allergic reactions or other problems. Talk to your||
8078|071|P|pharmacist for more details.||
8078|072|P|   Before using this medication, tell your doctor or pharmacist||
8078|073|P|your medical history, especially of: high potassium blood levels||
8078|074|P|(hyperkalemia), kidney disease, diabetes.||
8078|075|P|   This medication may increase your potassium levels. Before||
8078|076|P|using potassium supplements or salt substitutes that contain||
8078|077|P|potassium, consult your doctor or pharmacist.||
8078|078|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8078|079|P|can make you more dizzy. Do not drive, use machinery, or do||
8078|080|P|anything that needs alertness until you can do it safely. Limit||
8078|081|P|alcoholic beverages. Talk to your doctor if you are using||
8078|082|P|marijuana (cannabis).||
8078|083|P|   Before having surgery, tell your doctor or dentist about all||
8078|084|P|the products you use (including prescription drugs,||
8078|085|P|nonprescription drugs, and herbal products).||
8078|086|P|   Older adults may be more sensitive to the effects of this||
8078|087|P|drug, especially the raising of potassium blood levels.||
8078|088|P|   During pregnancy, this medication should be used only when||
8078|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
8078|090|P|   It is unknown if this drug passes into breast milk. Consult||
8078|091|P|your doctor before breastfeeding.||
8078|092|B|||
8078|093|I|DRUG INTERACTIONS:  See also Precautions section.||
8078|094|I|   Drug interactions may change how your medications work or||
8078|095|I|increase your risk for serious side effects. This document does||
8078|096|I|not contain all possible drug interactions. Keep a list of all||
8078|097|I|the products you use (including prescription/nonprescription||
8078|098|I|drugs and herbal products) and share it with your doctor and||
8078|099|I|pharmacist. Do not start, stop, or change the dosage of any||
8078|100|I|medicines without your doctor's approval.||
8078|101|I|   Some of the products that may interact with this drug include:||
8078|102|I|drugs that may increase the level of potassium in the blood (such||
8078|103|I|as birth control pills containing drospirenone, potassium sparing||
8078|104|I|"water pills" such as amiloride/spironolactone/triamterene),||
8078|105|I|lithium.||
8078|106|I|   Other medications can affect the removal of eplerenone from||
8078|107|I|your body, which may affect how eplerenone works. Examples||
8078|108|I|include adagrasib, certain azole antifungals (such as||
8078|109|I|ketoconazole, itraconazole), clarithromycin, cobicistat,||
8078|110|I|nefazodone, certain HIV protease inhibitors (such as nelfinavir),||
8078|111|I|ritonavir, St. John's wort, telithromycin, among others.||
8078|112|I|   Some products have ingredients that could raise your blood||
8078|113|I|pressure or worsen your heart failure. Tell your pharmacist what||
8078|114|I|products you are using, and ask how to use them safely||
8078|115|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
8078|116|I|ibuprofen/naproxen).||
8078|117|B|||
8078|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8078|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8078|120|O|poison control center right away. US residents can call||
8078|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8078|122|O|Symptoms of overdose may include: severe dizziness, severe muscle||
8078|123|O|weakness, or irregular heartbeat.||
8078|124|B|||
8078|125|N|NOTES:  Do not share this medication with others.||
8078|126|N|   Lifestyle changes that may help this medication work better||
8078|127|N|include exercising, stopping smoking, and eating a||
8078|128|N|low-cholesterol/low-fat diet. Consult your doctor for more||
8078|129|N|details.||
8078|130|N|   Lab and/or medical tests (such as potassium blood levels,||
8078|131|N|kidney function) should be done before you start taking this||
8078|132|N|medication and while you are taking it. Keep all medical and lab||
8078|133|N|appointments. Consult your doctor for more details.||
8078|134|N|   Have your blood pressure checked regularly while taking this||
8078|135|N|medication. Learn how to monitor your own blood pressure at home,||
8078|136|N|and share the results with your doctor.||
8078|137|B|||
8078|138|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8078|139|D|remember. If it is near the time of the next dose, skip the||
8078|140|D|missed dose. Take your next dose at the regular time. Do not||
8078|141|D|double the dose to catch up.||
8078|142|B|||
8078|143|R|STORAGE:  Store at room temperature away from light and moisture.||
8078|144|R|Do not store in the bathroom. Keep all medications away from||
8078|145|R|children and pets.||
8078|146|R|   Do not flush medications down the toilet or pour them into a||
8078|147|R|drain unless instructed to do so. Properly discard this product||
8078|148|R|when it is expired or no longer needed. Consult your pharmacist||
8078|149|R|or local waste disposal company.||
8078|150|B|||
8078|151|A|Information last revised May 2024.||
8078|152|A|Copyright(c) 2025 First Databank, Inc.||
8078|153|B|||
8085|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8085|002|Z|does NOT have all possible information about this product. This||
8085|003|Z|information does not assure that this product is safe, effective,||
8085|004|Z|or appropriate for you. This information is not individual||
8085|005|Z|medical advice and does not substitute for the advice of your||
8085|006|Z|health care professional. Always ask your health care||
8085|007|Z|professional for complete information about this product and your||
8085|008|Z|specific health needs.||
8085|009|B|||
8085|010|T|DOFETILIDE - ORAL||
8085|011|F|(doh-FET-ill-ide)||
8085|012|B|||
8085|013|C|COMMON BRAND NAME(S): Tikosyn||
8085|014|B|||
8085|015|W|WARNING:  Though this medication often gives great benefits to||
8085|016|W|people with irregular heartbeat, it may rarely cause a serious||
8085|017|W|new irregular heartbeat. When starting, restarting, or increasing||
8085|018|W|your dose with this drug, your doctor will recommend that you||
8085|019|W|stay in the hospital for at least 3 days for proper monitoring.||
8085|020|B|||
8085|021|U|USES:  This medication is used to treat certain types of serious||
8085|022|U|(possibly fatal) irregular heartbeat (such as atrial||
8085|023|U|fibrillation/flutter). It is used to restore normal heart rhythm||
8085|024|U|and maintain a regular, steady heartbeat. Dofetilide is known as||
8085|025|U|an anti-arrhythmic drug. It works by blocking the activity of||
8085|026|U|certain electrical signals in the heart that can cause an||
8085|027|U|irregular heartbeat. Treating an irregular heartbeat can decrease||
8085|028|U|the risk for blood clots, and this effect can reduce your risk of||
8085|029|U|heart attack or stroke.||
8085|030|B|||
8085|031|H|HOW TO USE:  Read the Medication Guide provided by your||
8085|032|H|pharmacist before you start taking dofetilide and each time you||
8085|033|H|get a refill. If you have any questions, ask your doctor or||
8085|034|H|pharmacist.||
8085|035|H|   Take this medication by mouth with or without food as directed||
8085|036|H|by your doctor, usually twice daily. To reduce your risk of||
8085|037|H|serious side effects, it is very important to take this||
8085|038|H|medication exactly as prescribed.||
8085|039|H|   The dosage is based on your medical condition and response to||
8085|040|H|treatment.||
8085|041|H|   Use this medication regularly to get the most benefit from it.||
8085|042|H|To help you remember, take it at the same times each day.||
8085|043|H|   Tell your doctor if your condition does not get better or if||
8085|044|H|it gets worse.||
8085|045|B|||
8085|046|S|SIDE EFFECTS:  Headache, dizziness, or nausea may occur. If any||
8085|047|S|of these effects last or get worse, tell your doctor or||
8085|048|S|pharmacist promptly.||
8085|049|S|   Remember that this medication has been prescribed because your||
8085|050|S|doctor has judged that the benefit to you is greater than the||
8085|051|S|risk of side effects. Many people using this medication do not||
8085|052|S|have serious side effects.||
8085|053|S|   Get medical help right away if you have any very serious side||
8085|054|S|effects, including: chest pain, fainting, faster/more irregular||
8085|055|S|heartbeat, severe dizziness.||
8085|056|S|   A very serious allergic reaction to this drug is rare.||
8085|057|S|However, get medical help right away if you notice any symptoms||
8085|058|S|of a serious allergic reaction, including: rash, itching/swelling||
8085|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8085|060|S|breathing.||
8085|061|S|   This is not a complete list of possible side effects. If you||
8085|062|S|notice other effects not listed above, contact your doctor or||
8085|063|S|pharmacist.||
8085|064|S|   In the US -||
8085|065|S|   Call your doctor for medical advice about side effects. You||
8085|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8085|067|S|www.fda.gov/medwatch.||
8085|068|S|   In Canada - Call your doctor for medical advice about side||
8085|069|S|effects. You may report side effects to Health Canada at||
8085|070|S|1-866-234-2345.||
8085|071|B|||
8085|072|P|PRECAUTIONS:  Before taking dofetilide, tell your doctor or||
8085|073|P|pharmacist if you are allergic to it; or if you have any other||
8085|074|P|allergies. This product may contain inactive ingredients, which||
8085|075|P|can cause allergic reactions or other problems. Talk to your||
8085|076|P|pharmacist for more details.||
8085|077|P|   Before using this medication, tell your doctor or pharmacist||
8085|078|P|your medical history, especially of: kidney problems, liver||
8085|079|P|disease.||
8085|080|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8085|081|P|can make you more dizzy. Do not drive, use machinery, or do||
8085|082|P|anything that needs alertness until you can do it safely. Limit||
8085|083|P|alcoholic beverages. Talk to your doctor if you are using||
8085|084|P|marijuana (cannabis).||
8085|085|P|   Dofetilide may cause a condition that affects the heart rhythm||
8085|086|P|(QT prolongation). QT prolongation can rarely cause serious||
8085|087|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
8085|088|P|as severe dizziness, fainting) that need medical attention right||
8085|089|P|away.||
8085|090|P|   The risk of QT prolongation may be increased if you have||
8085|091|P|certain medical conditions or are taking other drugs that may||
8085|092|P|cause QT prolongation. Before using dofetilide, tell your doctor||
8085|093|P|or pharmacist of all the drugs you take and if you have any of||
8085|094|P|the following conditions: certain heart problems (heart failure,||
8085|095|P|slow heartbeat, QT prolongation in the EKG), family history of||
8085|096|P|certain heart problems (QT prolongation in the EKG, sudden||
8085|097|P|cardiac death).||
8085|098|P|   Low levels of potassium or magnesium in the blood may also||
8085|099|P|increase your risk of QT prolongation. This risk may increase if||
8085|100|P|you use certain drugs (such as diuretics/"water pills") or if you||
8085|101|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8085|102|P|Talk to your doctor about using dofetilide safely.||
8085|103|P|   Older adults may be more sensitive to the side effects of this||
8085|104|P|drug, especially QT prolongation (see above).||
8085|105|P|   During pregnancy, this medication should be used only when||
8085|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
8085|107|P|   It is unknown if this drug passes into breast milk. Consult||
8085|108|P|your doctor before breastfeeding.||
8085|109|B|||
8085|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8085|111|I|medications work or increase your risk for serious side effects.||
8085|112|I|This document does not contain all possible drug interactions.||
8085|113|I|Keep a list of all the products you use (including||
8085|114|I|prescription/nonprescription drugs and herbal products) and share||
8085|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
8085|116|I|the dosage of any medicines without your doctor's approval.||
8085|117|I|   Some products that may interact with this drug include:||
8085|118|I|dolutegravir, fingolimod.||
8085|119|I|   Many drugs besides dofetilide may affect the heart rhythm (QT||
8085|120|I|prolongation), including amiodarone, pimozide, procainamide,||
8085|121|I|quinidine, sotalol, macrolide antibiotics (such as||
8085|122|I|clarithromycin, erythromycin), among others. (See also||
8085|123|I|Precautions section.)||
8085|124|I|   Other medications can affect the removal of dofetilide from||
8085|125|I|your body, which may affect how dofetilide works. Examples||
8085|126|I|include cephalexin, hydrochlorothiazide, indapamide,||
8085|127|I|itraconazole, ketoconazole, lamotrigine, megestrol,||
8085|128|I|prochlorperazine, tafenoquine, trilaciclib, trimethoprim,||
8085|129|I|verapamil, among others.||
8085|130|I|   Avoid taking cimetidine while being treated with dofetilide.||
8085|131|I|Ask your doctor or pharmacist about other medications for||
8085|132|I|heartburn/upset stomach.||
8085|133|B|||
8085|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8085|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8085|136|O|poison control center right away. US residents can call||
8085|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8085|138|O|Symptoms of overdose may include dizziness, fainting.||
8085|139|B|||
8085|140|N|NOTES:  Do not share this medication with others.||
8085|141|N|   Lab and/or medical tests (such as EKG, kidney function) should||
8085|142|N|be done before you start taking this medication and while you are||
8085|143|N|taking it. Keep all medical and lab appointments. Consult your||
8085|144|N|doctor for more details.||
8085|145|B|||
8085|146|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
8085|147|D|next dose at the regular time. Do not double the dose to catch||
8085|148|D|up.||
8085|149|B|||
8085|150|R|STORAGE:  Store at room temperature away from light and moisture.||
8085|151|R|Do not store in the bathroom. Keep all medications away from||
8085|152|R|children and pets.||
8085|153|R|   Do not flush medications down the toilet or pour them into a||
8085|154|R|drain unless instructed to do so. Properly discard this product||
8085|155|R|when it is expired or no longer needed. Consult your pharmacist||
8085|156|R|or local waste disposal company.||
8085|157|B|||
8085|158|M|MEDICAL ALERT:  Your condition can cause complications in a||
8085|159|M|medical emergency. For information about enrolling in MedicAlert,||
8085|160|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8085|161|B|||
8085|162|A|Information last revised May 2025.||
8085|163|A|Copyright(c) 2025 First Databank, Inc.||
8085|164|B|||
8087|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8087|002|Z|does NOT have all possible information about this product. This||
8087|003|Z|information does not assure that this product is safe, effective,||
8087|004|Z|or appropriate for you. This information is not individual||
8087|005|Z|medical advice and does not substitute for the advice of your||
8087|006|Z|health care professional. Always ask your health care||
8087|007|Z|professional for complete information about this product and your||
8087|008|Z|specific health needs.||
8087|009|B|||
8087|010|T|CYCLOBENZAPRINE - ORAL||
8087|011|F|(sye-klo-BENZ-uh-preen)||
8087|012|B|||
8087|013|C|COMMON BRAND NAME(S): Flexeril||
8087|014|B|||
8087|015|U|USES:  Cyclobenzaprine is used short-term to treat muscle spasms.||
8087|016|U|It is usually used along with rest and physical therapy. It works||
8087|017|U|by helping to relax the muscles.||
8087|018|B|||
8087|019|H|HOW TO USE:  Take this medication by mouth with or without food||
8087|020|H|as directed by your doctor. Do not increase your dose or use this||
8087|021|H|drug more often or for longer than prescribed. Your condition||
8087|022|H|will not improve any faster, and your risk of side effects will||
8087|023|H|increase.||
8087|024|H|   The dosage is based on your medical condition and response to||
8087|025|H|treatment. This medication should only be used short-term (for 3||
8087|026|H|weeks or less) unless directed by your doctor.||
8087|027|H|   Tell your doctor if your condition lasts after 2 to 3 weeks or||
8087|028|H|if it gets worse.||
8087|029|B|||
8087|030|S|SIDE EFFECTS:  Drowsiness, dizziness, dry mouth, constipation, or||
8087|031|S|tiredness may occur. If any of these effects last or get worse,||
8087|032|S|tell your doctor or pharmacist promptly.||
8087|033|S|   Remember that this medication has been prescribed because your||
8087|034|S|doctor has judged that the benefit to you is greater than the||
8087|035|S|risk of side effects. Many people using this medication do not||
8087|036|S|have serious side effects.||
8087|037|S|   Tell your doctor right away if you have any serious side||
8087|038|S|effects, including: fast/irregular heartbeat, mental/mood changes||
8087|039|S|(such as confusion, hallucinations), trouble urinating.||
8087|040|S|   A very serious allergic reaction to this drug is rare.||
8087|041|S|However, get medical help right away if you notice any symptoms||
8087|042|S|of a serious allergic reaction, including: rash, itching/swelling||
8087|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8087|044|S|breathing.||
8087|045|S|   This is not a complete list of possible side effects. If you||
8087|046|S|notice other effects not listed above, contact your doctor or||
8087|047|S|pharmacist.||
8087|048|S|   In the US -||
8087|049|S|   Call your doctor for medical advice about side effects. You||
8087|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8087|051|S|www.fda.gov/medwatch.||
8087|052|S|   In Canada - Call your doctor for medical advice about side||
8087|053|S|effects. You may report side effects to Health Canada at||
8087|054|S|1-866-234-2345.||
8087|055|B|||
8087|056|P|PRECAUTIONS:  Before taking cyclobenzaprine, tell your doctor or||
8087|057|P|pharmacist if you are allergic to it; or if you have any other||
8087|058|P|allergies. This product may contain inactive ingredients, which||
8087|059|P|can cause allergic reactions or other problems. Talk to your||
8087|060|P|pharmacist for more details.||
8087|061|P|   Before using this medication, tell your doctor or pharmacist||
8087|062|P|your medical history, especially of: liver disease, overactive||
8087|063|P|thyroid (hyperthyroidism), heart problems (such as irregular||
8087|064|P|heartbeat, heart block, heart failure, recent heart attack),||
8087|065|P|difficulty urinating (such as due to an enlarged prostate),||
8087|066|P|glaucoma.||
8087|067|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8087|068|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8087|069|P|machinery, or do anything that needs alertness until you can do||
8087|070|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
8087|071|P|are using marijuana (cannabis).||
8087|072|P|   Before having surgery, tell your doctor or dentist about all||
8087|073|P|the products you use (including prescription drugs,||
8087|074|P|nonprescription drugs, and herbal products).||
8087|075|P|   Older adults may be more sensitive to the side effects of this||
8087|076|P|drug, especially drowsiness, confusion, constipation, or trouble||
8087|077|P|urinating. Drowsiness and confusion can increase the risk of||
8087|078|P|falling.||
8087|079|P|   During pregnancy, this medication should be used only when||
8087|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
8087|081|P|   This medication passes into breast milk. Consult your doctor||
8087|082|P|before breastfeeding.||
8087|083|B|||
8087|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8087|085|I|medications work or increase your risk for serious side effects.||
8087|086|I|This document does not contain all possible drug interactions.||
8087|087|I|Keep a list of all the products you use (including||
8087|088|I|prescription/nonprescription drugs and herbal products) and share||
8087|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
8087|090|I|the dosage of any medicines without your doctor's approval.||
8087|091|I|   Some products that may interact with this drug include:||
8087|092|I|tricyclic antidepressants (such as amitriptyline, imipramine).||
8087|093|I|   Taking MAO inhibitors with this medication may cause a serious||
8087|094|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
8087|095|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8087|096|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8087|097|I|selegiline, tranylcypromine) during treatment with this||
8087|098|I|medication. Most MAO inhibitors should also not be taken for two||
8087|099|I|weeks before treatment with this medication. Ask your doctor when||
8087|100|I|to start or stop taking this medication.||
8087|101|I|   Before using this medication, report the use of drugs that||
8087|102|I|increase serotonin, including street drugs (such as||
8087|103|I|MDMA/"ecstasy"), St. John's wort, certain antidepressants||
8087|104|I|(including SSRIs such as fluoxetine/paroxetine, SNRIs such as||
8087|105|I|duloxetine/venlafaxine), tramadol, among others.||
8087|106|I|   Tell your doctor or pharmacist if you are taking other||
8087|107|I|products that cause drowsiness such as opioid pain or cough||
8087|108|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8087|109|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
8087|110|I|lorazepam, zolpidem), other muscle relaxants (such as||
8087|111|I|carisoprodol, methocarbamol), or antihistamines (such as||
8087|112|I|cetirizine, diphenhydramine).||
8087|113|I|   Check the labels on all your medicines (such as allergy or||
8087|114|I|cough-and-cold products) because they may contain ingredients||
8087|115|I|that cause drowsiness. Ask your pharmacist about using those||
8087|116|I|products safely.||
8087|117|B|||
8087|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8087|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8087|120|O|poison control center right away. US residents can call||
8087|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8087|122|O|Symptoms of overdose may include: fast/irregular heartbeat,||
8087|123|O|fainting, severe drowsiness, trouble speaking, seizures,||
8087|124|O|mental/mood changes (such as confusion, hallucinations).||
8087|125|B|||
8087|126|N|NOTES:  Do not share this medication with others.||
8087|127|N|   This medication has been prescribed for your current condition||
8087|128|N|only. Do not use it later for another condition unless your||
8087|129|N|doctor directs you to do so. A different medication may be||
8087|130|N|necessary in that case.||
8087|131|B|||
8087|132|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8087|133|D|remember. If it is near the time of the next dose, skip the||
8087|134|D|missed dose. Take your next dose at the regular time. Do not||
8087|135|D|double the dose to catch up.||
8087|136|B|||
8087|137|R|STORAGE:  Store at room temperature away from light and moisture.||
8087|138|R|Do not store in the bathroom. Keep all medications away from||
8087|139|R|children and pets.||
8087|140|R|   Do not flush medications down the toilet or pour them into a||
8087|141|R|drain unless instructed to do so. Properly discard this product||
8087|142|R|when it is expired or no longer needed. Consult your pharmacist||
8087|143|R|or local waste disposal company.||
8087|144|B|||
8087|145|A|Information last revised August 2025.||
8087|146|A|Copyright(c) 2025 First Databank, Inc.||
8087|147|B|||
8089|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8089|002|Z|does NOT have all possible information about this product. This||
8089|003|Z|information does not assure that this product is safe, effective,||
8089|004|Z|or appropriate for you. This information is not individual||
8089|005|Z|medical advice and does not substitute for the advice of your||
8089|006|Z|health care professional. Always ask your health care||
8089|007|Z|professional for complete information about this product and your||
8089|008|Z|specific health needs.||
8089|009|B|||
8089|010|T|NEFAZODONE - ORAL||
8089|011|F|(neh-FAZZ-oh-doan)||
8089|012|B|||
8089|013|C|COMMON BRAND NAME(S): Serzone||
8089|014|B|||
8089|015|W|WARNING:  Antidepressant medications are used to treat a variety||
8089|016|W|of conditions, including depression and other mental/mood||
8089|017|W|disorders. These medications can help prevent suicidal||
8089|018|W|thoughts/attempts and provide other important benefits. However,||
8089|019|W|studies have shown that a small number of people (especially||
8089|020|W|people younger than 25) who take antidepressants for any||
8089|021|W|condition may experience worsening depression, other mental/mood||
8089|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
8089|023|W|talk with the doctor about the risks and benefits of||
8089|024|W|antidepressant medication (especially for people younger than||
8089|025|W|25), even if treatment is not for a mental/mood condition.||
8089|026|W|   Tell the doctor right away if you notice worsening||
8089|027|W|depression/other psychiatric conditions, unusual behavior changes||
8089|028|W|(including possible suicidal thoughts/attempts), or other||
8089|029|W|mental/mood changes (including new/worsening anxiety, panic||
8089|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
8089|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
8089|032|W|especially watchful for these symptoms when a new antidepressant||
8089|033|W|is started or when the dose is changed.||
8089|034|W|   Nefazodone has rarely caused very serious (possibly fatal)||
8089|035|W|liver disease. Tell your doctor right away if you develop||
8089|036|W|symptoms of liver disease, including nausea/vomiting that doesn't||
8089|037|W|stop, severe stomach/abdominal pain, unusual tiredness, loss of||
8089|038|W|appetite, dark urine, yellowing eyes/skin.||
8089|039|W|   Before using this medication, tell your doctor if you have||
8089|040|W|liver disease or abnormal liver function tests.||
8089|041|W|   Your doctor should perform liver function tests periodically||
8089|042|W|while you are taking this medication. If your doctor directs you||
8089|043|W|to stop taking this medication because of liver problems or||
8089|044|W|abnormal liver function tests, you should not take this drug||
8089|045|W|again. Consult your doctor or pharmacist for more details.||
8089|046|B|||
8089|047|U|USES:  This medication is used to treat depression. Because of||
8089|048|U|the risk of liver disease, this medication is usually used after||
8089|049|U|trying other drugs. Nefazodone works by helping to restore the||
8089|050|U|balance of certain natural substances (serotonin, norepinephrine)||
8089|051|U|in the brain.||
8089|052|B|||
8089|053|H|HOW TO USE:  Read the Medication Guide and, if available, the||
8089|054|H|Patient Information Leaflet provided by your pharmacist before||
8089|055|H|you start using nefazodone and each time you get a refill. If you||
8089|056|H|have any questions, ask your doctor or pharmacist.||
8089|057|H|   Take this medication by mouth with or without food as directed||
8089|058|H|by your doctor, usually twice daily.||
8089|059|H|   Dosage is based on your medical condition and response to||
8089|060|H|treatment. To reduce your risk of side effects, your doctor may||
8089|061|H|start you at a low dose and gradually increase your dose.||
8089|062|H|   Take this medication exactly as prescribed. Do not increase||
8089|063|H|your dose or take this medication more often than prescribed.||
8089|064|H|Your condition will not improve any faster, and the risk of||
8089|065|H|serious side effects may be increased.||
8089|066|H|   Use this medication regularly in order to get the most benefit||
8089|067|H|from it. To help you remember, take it at the same times each||
8089|068|H|day.||
8089|069|H|   Keep taking this medication even if you feel well. Do not stop||
8089|070|H|taking this medication without consulting your doctor.||
8089|071|H|   It may take several weeks before this drug takes effect. Tell||
8089|072|H|your doctor if your condition lasts or gets worse.||
8089|073|B|||
8089|074|S|SIDE EFFECTS:  See also Warning section.||
8089|075|S|   Dizziness, drowsiness, lightheadedness, nausea, dry mouth, or||
8089|076|S|constipation may occur. If any of these effects last or get||
8089|077|S|worse, tell your doctor or pharmacist promptly.||
8089|078|S|   To reduce the risk of dizziness and lightheadedness, get up||
8089|079|S|slowly when rising from a sitting or lying position.||
8089|080|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
8089|081|S|chips, chew (sugarless) gum, drink water, or use a saliva||
8089|082|S|substitute.||
8089|083|S|   Remember that this medication has been prescribed because your||
8089|084|S|doctor has judged that the benefit to you is greater than the||
8089|085|S|risk of side effects. Many people using this medication do not||
8089|086|S|have serious side effects.||
8089|087|S|   Tell your doctor right away if you have any serious side||
8089|088|S|effects, including: confusion, weakness, fainting, seizures, easy||
8089|089|S|bleeding/bruising.||
8089|090|S|   Get medical help right away if you have any very serious side||
8089|091|S|effects, including: black stools, vomit that looks like coffee||
8089|092|S|grounds, eye pain/swelling/redness, widened pupils, vision||
8089|093|S|changes (such as seeing rainbows around lights at night, blurred||
8089|094|S|vision).||
8089|095|S|   Rarely, males may have a painful or prolonged erection lasting||
8089|096|S|4 or more hours. If this occurs, stop using this drug and get||
8089|097|S|medical help right away, or permanent problems could occur.||
8089|098|S|   A very serious allergic reaction to this drug is rare.||
8089|099|S|However, get medical help right away if you notice any symptoms||
8089|100|S|of a serious allergic reaction, including: rash, itching/swelling||
8089|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8089|102|S|breathing.||
8089|103|S|   This is not a complete list of possible side effects. If you||
8089|104|S|notice other effects not listed above, contact your doctor or||
8089|105|S|pharmacist.||
8089|106|S|   In the US -||
8089|107|S|   Call your doctor for medical advice about side effects. You||
8089|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8089|109|S|www.fda.gov/medwatch.||
8089|110|S|   In Canada - Call your doctor for medical advice about side||
8089|111|S|effects. You may report side effects to Health Canada at||
8089|112|S|1-866-234-2345.||
8089|113|B|||
8089|114|P|PRECAUTIONS:  See also Warning section.||
8089|115|P|   Before taking nefazodone, tell your doctor or pharmacist if||
8089|116|P|you are allergic to it; or to trazodone; or if you have any other||
8089|117|P|allergies. This product may contain inactive ingredients, which||
8089|118|P|can cause allergic reactions or other problems. Talk to your||
8089|119|P|pharmacist for more details.||
8089|120|P|   Before using this medication, tell your doctor or pharmacist||
8089|121|P|your medical history, especially of: liver disease, personal or||
8089|122|P|family history of psychiatric disorder (such as||
8089|123|P|bipolar/manic-depressive disorder), personal or family history of||
8089|124|P|suicide attempts, heart/blood vessel disease (such as history of||
8089|125|P|stroke/heart attack), dehydration, seizures, intestinal||
8089|126|P|ulcers/bleeding (peptic ulcer disease), personal or family||
8089|127|P|history of glaucoma (angle-closure type).||
8089|128|P|   Before having surgery, tell your doctor or dentist about all||
8089|129|P|the products you use (including prescription drugs,||
8089|130|P|nonprescription drugs, and herbal products).||
8089|131|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8089|132|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8089|133|P|machinery, or do anything that needs alertness until you can do||
8089|134|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
8089|135|P|are using marijuana (cannabis). Alcohol may also cause liver||
8089|136|P|disease.||
8089|137|P|   Older adults may be more sensitive to the side effects of this||
8089|138|P|drug, especially dizziness/drowsiness or bleeding.||
8089|139|P|   During pregnancy, this medication should be used only when||
8089|140|P|clearly needed. Discuss the risks and benefits with your doctor.||
8089|141|P|   Since untreated mental/mood problems (such as depression) can||
8089|142|P|be a serious condition, do not stop taking this medication unless||
8089|143|P|directed by your doctor. If you are planning pregnancy, become||
8089|144|P|pregnant, or think you may be pregnant, immediately discuss with||
8089|145|P|your doctor the benefits and risks of using this medication||
8089|146|P|during pregnancy.||
8089|147|P|   It is unknown if this drug passes into breast milk. Consult||
8089|148|P|your doctor before breastfeeding.||
8089|149|B|||
8089|150|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8089|151|I|medications work or increase your risk for serious side effects.||
8089|152|I|This document does not contain all possible drug interactions.||
8089|153|I|Keep a list of all the products you use (including||
8089|154|I|prescription/nonprescription drugs and herbal products) and share||
8089|155|I|it with your doctor and pharmacist. Do not start, stop, or change||
8089|156|I|the dosage of any medicines without your doctor's approval.||
8089|157|I|   Some products that may interact with this drug include:||
8089|158|I|carbamazepine, eplerenone, ergot alkaloids (such as||
8089|159|I|dihydroergotamine, ergonovine, ergotamine, methylergonovine),||
8089|160|I|ivabradine, lurasidone, pimozide, triazolam, alpha blockers (such||
8089|161|I|as terazosin), digoxin, fluoxetine, medications for high blood||
8089|162|I|pressure, other antidepressants (including trazodone, SSRIs such||
8089|163|I|as fluoxetine), other drugs that can cause bleeding/bruising (for||
8089|164|I|example, anticoagulants such as heparin or warfarin, antiplatelet||
8089|165|I|drugs including NSAIDs such as ibuprofen).||
8089|166|I|   Taking MAO inhibitors with this medication may cause a serious||
8089|167|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
8089|168|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8089|169|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8089|170|I|selegiline, tranylcypromine) during treatment with this||
8089|171|I|medication. Most MAO inhibitors should also not be taken for two||
8089|172|I|weeks before and 1 week after treatment with this medication. Ask||
8089|173|I|your doctor when to start or stop taking this medication.||
8089|174|I|   Avoid taking eletriptan within 72 hours of taking this||
8089|175|I|medication.||
8089|176|I|   This medication can slow down the removal of other medications||
8089|177|I|from your body, which may affect how they work. Examples of||
8089|178|I|affected drugs include buspirone, dasatinib, domperidone,||
8089|179|I|fentanyl, regorafenib, sunitinib, tacrolimus, "statin"||
8089|180|I|cholesterol drugs (such as simvastatin, lovastatin,||
8089|181|I|atorvastatin), certain benzodiazepines (such as alprazolam) among||
8089|182|I|others.||
8089|183|I|   Tell your doctor or pharmacist if you are taking other||
8089|184|I|products that cause drowsiness such as opioid pain or cough||
8089|185|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8089|186|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
8089|187|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
8089|188|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8089|189|I|diphenhydramine).||
8089|190|I|   Check the labels on all your medicines (such as allergy or||
8089|191|I|cough-and-cold products) because they may contain ingredients||
8089|192|I|that cause drowsiness. Ask your pharmacist about using those||
8089|193|I|products safely.||
8089|194|I|   Check all prescription and nonprescription medicine labels||
8089|195|I|carefully since many medications contain pain relievers/fever||
8089|196|I|reducers (NSAIDs such as aspirin, ibuprofen, naproxen) that may||
8089|197|I|increase your risk for bleeding if taken together with this drug.||
8089|198|I|However, if your doctor has told you to take low-dose aspirin to||
8089|199|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
8089|200|I|you should keep taking the aspirin unless your doctor tells you||
8089|201|I|not to. Ask your doctor or pharmacist for more details.||
8089|202|B|||
8089|203|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8089|204|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8089|205|O|poison control center right away. US residents can call||
8089|206|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8089|207|O|Symptoms of overdose may include: nausea, vomiting, extreme||
8089|208|O|drowsiness.||
8089|209|B|||
8089|210|N|NOTES:  Do not share this medication with others.||
8089|211|N|   Lab and/or medical tests (such as liver function) should be||
8089|212|N|done while you are taking this medication. Keep all medical and||
8089|213|N|lab appointments. Consult your doctor for more details.||
8089|214|B|||
8089|215|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8089|216|D|remember. If it is near the time of the next dose, skip the||
8089|217|D|missed dose. Take your next dose at the regular time. Do not||
8089|218|D|double the dose to catch up.||
8089|219|B|||
8089|220|R|STORAGE:  Store at room temperature away from light and moisture.||
8089|221|R|Do not store in the bathroom. Keep all medications away from||
8089|222|R|children and pets.||
8089|223|R|   Do not flush medications down the toilet or pour them into a||
8089|224|R|drain unless instructed to do so. Properly discard this product||
8089|225|R|when it is expired or no longer needed. Consult your pharmacist||
8089|226|R|or local waste disposal company.||
8089|227|B|||
8089|228|A|Information last revised May 2024.||
8089|229|A|Copyright(c) 2025 First Databank, Inc.||
8089|230|B|||
8090|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8090|002|Z|does NOT have all possible information about this product. This||
8090|003|Z|information does not assure that this product is safe, effective,||
8090|004|Z|or appropriate for you. This information is not individual||
8090|005|Z|medical advice and does not substitute for the advice of your||
8090|006|Z|health care professional. Always ask your health care||
8090|007|Z|professional for complete information about this product and your||
8090|008|Z|specific health needs.||
8090|009|B|||
8090|010|T|TRIMEBUTINE - ORAL||
8090|011|F|(try-meh-BYOU-teen)||
8090|012|B|||
8090|013|U|USES:  Trimebutine is used to make the movement of the intestinal||
8090|014|U|tract more normal. This medication slows down or speeds up the||
8090|015|U|movement of the intestines if the gut is not working well. It||
8090|016|U|does not affect a normally working gut. It is used to treat||
8090|017|U|symptoms (such as abdominal pain/fullness, gas, diarrhea,||
8090|018|U|constipation) of irritable bowel syndrome (spastic colon).||
8090|019|U|Trimebutine is also used to restart the movement of the gut after||
8090|020|U|abdominal surgery and to prevent intestinal blockage (paralytic||
8090|021|U|ileus).||
8090|022|B|||
8090|023|H|HOW TO USE:  Take this medication by mouth before meals as||
8090|024|H|directed by your doctor, usually 3 times daily.||
8090|025|H|   Dosage is based on your medical condition and response to||
8090|026|H|treatment. Do not increase the dose, take this medication more||
8090|027|H|often, or keep taking it for longer than prescribed.||
8090|028|H|   Use this medication regularly to get the most benefit from it.||
8090|029|H|To help you remember, take it at the same times each day.||
8090|030|H|   Tell your doctor if your condition lasts or gets worse.||
8090|031|B|||
8090|032|S|SIDE EFFECTS:  Dry mouth, heartburn, nausea, diarrhea,||
8090|033|S|constipation, drowsiness, dizziness, tiredness or headache may||
8090|034|S|occur. If any of these effects last or get worse, tell your||
8090|035|S|doctor or pharmacist promptly.||
8090|036|S|   Remember that this medication has been prescribed because your||
8090|037|S|doctor has judged that the benefit to you is greater than the||
8090|038|S|risk of side effects. Many people using this medication do not||
8090|039|S|have serious side effects.||
8090|040|S|   Tell your doctor right away if you have any serious side||
8090|041|S|effects, including: difficulty urinating, painful enlargement of||
8090|042|S|the breast, hearing trouble.||
8090|043|S|   A very serious allergic reaction to this drug is rare.||
8090|044|S|However, get medical help right away if you notice any symptoms||
8090|045|S|of a serious allergic reaction, including: rash, itching/swelling||
8090|046|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8090|047|S|breathing.||
8090|048|S|   This is not a complete list of possible side effects. If you||
8090|049|S|notice other effects not listed above, contact your doctor or||
8090|050|S|pharmacist.||
8090|051|S|   In the US -||
8090|052|S|   Call your doctor for medical advice about side effects. You||
8090|053|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8090|054|S|www.fda.gov/medwatch.||
8090|055|S|   In Canada - Call your doctor for medical advice about side||
8090|056|S|effects. You may report side effects to Health Canada at||
8090|057|S|1-866-234-2345.||
8090|058|B|||
8090|059|P|PRECAUTIONS:  Before taking trimebutine, tell your doctor or||
8090|060|P|pharmacist if you are allergic to it; or if you have any other||
8090|061|P|allergies. This product may contain inactive ingredients, which||
8090|062|P|can cause allergic reactions or other problems. Talk to your||
8090|063|P|pharmacist for more details.||
8090|064|P|   Before using this medication, tell your doctor or pharmacist||
8090|065|P|your medical history, especially of: liver disease.||
8090|066|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8090|067|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8090|068|P|machinery, or do anything that needs alertness until you can do||
8090|069|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8090|070|P|are using marijuana (cannabis).||
8090|071|P|   Before having surgery, tell your doctor or dentist about all||
8090|072|P|the products you use (including prescription drugs,||
8090|073|P|nonprescription drugs, and herbal products).||
8090|074|P|   Tell your doctor if you are pregnant or plan to become||
8090|075|P|pregnant. You should not become pregnant while using trimebutine.||
8090|076|P|Trimebutine may harm an unborn baby. If you become pregnant, talk||
8090|077|P|to your doctor right away about the risks and benefits of this||
8090|078|P|medication.||
8090|079|P|   This medication may pass into breast milk. Consult your doctor||
8090|080|P|before breastfeeding.||
8090|081|B|||
8090|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8090|083|I|medications work or increase your risk for serious side effects.||
8090|084|I|This document does not contain all possible drug interactions.||
8090|085|I|Keep a list of all the products you use (including||
8090|086|I|prescription/nonprescription drugs and herbal products) and share||
8090|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
8090|088|I|the dosage of any medicines without your doctor's approval.||
8090|089|I|   A product that may interact with this drug is: pramlintide.||
8090|090|B|||
8090|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8090|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8090|093|O|poison control center right away. US residents can call||
8090|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8090|095|O|Symptoms of overdose may include: slow/shallow breathing.||
8090|096|B|||
8090|097|N|NOTES:  Do not share this medication with others.||
8090|098|B|||
8090|099|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8090|100|D|remember. If it is near the time of the next dose, skip the||
8090|101|D|missed dose. Take your next dose at the regular time. Do not||
8090|102|D|double the dose to catch up.||
8090|103|B|||
8090|104|R|STORAGE:  Store at room temperature away from light and moisture.||
8090|105|R|Do not store in the bathroom. Keep all medications away from||
8090|106|R|children and pets.||
8090|107|R|   Do not flush medications down the toilet or pour them into a||
8090|108|R|drain unless instructed to do so. Properly discard this product||
8090|109|R|when it is expired or no longer needed. Consult your pharmacist||
8090|110|R|or local waste disposal company.||
8090|111|B|||
8090|112|A|Information last revised May 2024.||
8090|113|A|Copyright(c) 2025 First Databank, Inc.||
8090|114|B|||
8091|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8091|002|Z|does NOT have all possible information about this product. This||
8091|003|Z|information does not assure that this product is safe, effective,||
8091|004|Z|or appropriate for you. This information is not individual||
8091|005|Z|medical advice and does not substitute for the advice of your||
8091|006|Z|health care professional. Always ask your health care||
8091|007|Z|professional for complete information about this product and your||
8091|008|Z|specific health needs.||
8091|009|B|||
8091|010|T|FRAMYCETIN/GRAMICIDIN/PHENYLEPHRINE SPRAY - NASAL||
8091|011|F|(fram-eye-SEAT-in/gram-ih-SYE-din/fen-ill-EFF-rin)||
8091|012|B|||
8091|013|U|USES:  This product contains 3 medications, a decongestant and 2||
8091|014|U|antibiotics. Phenylephrine is a decongestant that is used for||
8091|015|U|temporary relief of stuffy nose caused by various conditions,||
8091|016|U|including the common cold, sinusitis, hay fever, allergies, nasal||
8091|017|U|or sinus surgery. It works by narrowing the blood vessels in the||
8091|018|U|nose area. This effect reduces swelling/stuffiness and dries up||
8091|019|U|mucus. It temporarily helps you breathe better through your nose.||
8091|020|U|   This medication also contains framycetin (also known as||
8091|021|U|neomycin B) and gramicidin, antibiotics that work by stopping the||
8091|022|U|growth of bacteria.||
8091|023|U|   Antibiotics treat only bacterial infections. They will not||
8091|024|U|work for viral infections (such as common cold, flu). Bacterial||
8091|025|U|infections of the nose or sinus may need to be treated with a||
8091|026|U|different medication taken by mouth. Using any antibiotic when it||
8091|027|U|is not needed can cause it to not work for future infections.||
8091|028|U|   This medication has also been used as part of an infection||
8091|029|U|control program to temporarily get rid of certain bacteria found||
8091|030|U|in the nose (Staphylococcus, also known as staph).||
8091|031|U|   This medication should not be used by children younger than 2||
8091|032|U|years.||
8091|033|B|||
8091|034|H|HOW TO USE:  Gently blow your nose before using this drug. Use||
8091|035|H|this product as directed by your doctor, usually 2 sprays in each||
8091|036|H|nostril every 4 hours (for treating an infection or stuffy nose)||
8091|037|H|or 2 sprays in each nostril twice daily (for reducing staph||
8091|038|H|bacteria in the nose). Do not use this medication more than 6||
8091|039|H|times in 24 hours. Your dosage is based on your medical condition||
8091|040|H|and response to treatment.||
8091|041|H|   Use your finger to close the nostril on the side not receiving||
8091|042|H|the medication. While keeping your head upright, place the spray||
8091|043|H|tip into the open nostril. Spray the medication into the open||
8091|044|H|nostril as you breathe in through your nose. Sniff hard a few||
8091|045|H|times to be sure the medication reaches deep into the nose.||
8091|046|H|Repeat these steps for the other nostril if needed. Avoid||
8091|047|H|spraying the medication into your eyes or onto the middle of the||
8091|048|H|inside of your nose (nasal septum). Rinse the spray tip with hot||
8091|049|H|water or wipe with a clean tissue after each use. Make sure that||
8091|050|H|water does not get inside the container. Replace cap after each||
8091|051|H|use.||
8091|052|H|   This medication provides only temporary relief. Do not use||
8091|053|H|this medication more often, use more sprays, or use it longer||
8091|054|H|than directed because doing so may increase the risk of side||
8091|055|H|effects. Also, do not use this medication for longer than 3 to 5||
8091|056|H|days or it may cause a condition called rebound congestion.||
8091|057|H|Symptoms of rebound congestion include long-term redness and||
8091|058|H|swelling inside the nose and increased runny nose. If this||
8091|059|H|occurs, stop using this medication and consult your doctor or||
8091|060|H|pharmacist. Tell your doctor if your condition gets worse or||
8091|061|H|lasts after 3 days.||
8091|062|B|||
8091|063|S|SIDE EFFECTS:  Temporary burning, stinging, dryness in the nose,||
8091|064|S|and sneezing may occur. If any of these effects last or get||
8091|065|S|worse, tell your doctor or pharmacist promptly.||
8091|066|S|   Remember that this medication has been prescribed because your||
8091|067|S|doctor has judged that the benefit to you is greater than the||
8091|068|S|risk of side effects. Many people using this medication do not||
8091|069|S|have serious side effects.||
8091|070|S|   Tell your doctor right away if you have any serious side||
8091|071|S|effects, including: slow/fast/pounding heartbeat, dizziness,||
8091|072|S|feeling of spinning (vertigo), severe/pounding headache, hearing||
8091|073|S|problems (such as ringing in the ears, hearing loss), loss of||
8091|074|S|balance, mental/mood changes (such as nervousness), trouble||
8091|075|S|sleeping, blurred vision.||
8091|076|S|   Use of this medication for prolonged or repeated periods may||
8091|077|S|result in a new fungal infection (such as thrush). Do not use||
8091|078|S|this medication for longer than prescribed. Contact your doctor||
8091|079|S|if you notice white patches in your mouth or other new symptoms.||
8091|080|S|   A very serious allergic reaction to this drug is rare.||
8091|081|S|However, get medical help right away if you notice any symptoms||
8091|082|S|of a serious allergic reaction, including: rash, itching/swelling||
8091|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8091|084|S|breathing.||
8091|085|S|   This is not a complete list of possible side effects. If you||
8091|086|S|notice other effects not listed above, contact your doctor or||
8091|087|S|pharmacist.||
8091|088|S|   In the US -||
8091|089|S|   Call your doctor for medical advice about side effects. You||
8091|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8091|091|S|www.fda.gov/medwatch.||
8091|092|S|   In Canada - Call your doctor for medical advice about side||
8091|093|S|effects. You may report side effects to Health Canada at||
8091|094|S|1-866-234-2345.||
8091|095|B|||
8091|096|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
8091|097|P|pharmacist if you are allergic to framycetin or other||
8091|098|P|aminoglycoside antibiotics (such as neomycin, gentamicin); or to||
8091|099|P|gramicidin; or to phenylephrine or other sympathomimetics (such||
8091|100|P|as pseudoephedrine); or if you have any other allergies. This||
8091|101|P|product may contain inactive ingredients, which can cause||
8091|102|P|allergic reactions or other problems. Talk to your pharmacist for||
8091|103|P|more details.||
8091|104|P|   Before using this medication, tell your doctor or pharmacist||
8091|105|P|your medical history, especially of: narrow-angle glaucoma,||
8091|106|P|severe dry nose (rhinitis sicca), diabetes, heart/blood vessel||
8091|107|P|disease (such as chest pain, stroke, heart attack), high blood||
8091|108|P|pressure, overactive thyroid (hyperthyroidism).||
8091|109|P|   Before having surgery, tell your doctor or dentist about all||
8091|110|P|the products you use (including prescription drugs,||
8091|111|P|nonprescription drugs, and herbal products).||
8091|112|P|   During pregnancy, this medication should be used only when||
8091|113|P|clearly needed. Discuss the risks and benefits with your doctor.||
8091|114|P|   It is unknown if this drug passes into breast milk. Consult||
8091|115|P|your doctor before breastfeeding.||
8091|116|B|||
8091|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8091|118|I|medications work or increase your risk for serious side effects.||
8091|119|I|This document does not contain all possible drug interactions.||
8091|120|I|Keep a list of all the products you use (including||
8091|121|I|prescription/nonprescription drugs and herbal products) and share||
8091|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
8091|123|I|the dosage of any medicines without your doctor's approval.||
8091|124|I|   Taking MAO inhibitors with this medication may cause a serious||
8091|125|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
8091|126|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8091|127|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8091|128|I|selegiline, tranylcypromine) during treatment with this||
8091|129|I|medication. Most MAO inhibitors should also not be taken for two||
8091|130|I|weeks before treatment with this medication. Ask your doctor when||
8091|131|I|to start or stop taking this medication.||
8091|132|B|||
8091|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8091|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8091|135|O|poison control center right away. US residents can call||
8091|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8091|137|O|Symptoms of overdose may include: drowsiness, slow heartbeat,||
8091|138|O|fainting.||
8091|139|B|||
8091|140|N|NOTES:  Do not share this medication with others.||
8091|141|B|||
8091|142|D|MISSED DOSE:  If you are using this medication on a regular||
8091|143|D|schedule and miss a dose, use it as soon as you remember. If it||
8091|144|D|is near the time of the next dose, skip the missed dose. Use your||
8091|145|D|next dose at the regular time. Do not double the dose to catch||
8091|146|D|up.||
8091|147|B|||
8091|148|R|STORAGE:  Store at room temperature. Keep all medications away||
8091|149|R|from children and pets.||
8091|150|R|   Do not flush medications down the toilet or pour them into a||
8091|151|R|drain unless instructed to do so. Properly discard this product||
8091|152|R|when it is expired or no longer needed. Consult your pharmacist||
8091|153|R|or local waste disposal company.||
8091|154|B|||
8091|155|A|Information last revised May 2024.||
8091|156|A|Copyright(c) 2025 First Databank, Inc.||
8091|157|B|||
8094|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8094|002|Z|does NOT have all possible information about this product. This||
8094|003|Z|information does not assure that this product is safe, effective,||
8094|004|Z|or appropriate for you. This information is not individual||
8094|005|Z|medical advice and does not substitute for the advice of your||
8094|006|Z|health care professional. Always ask your health care||
8094|007|Z|professional for complete information about this product and your||
8094|008|Z|specific health needs.||
8094|009|B|||
8094|010|T|METHYLPHENIDATE SUSTAINED-ACTION TABLET - ORAL||
8094|011|F|(METH-il-FEN-i-date)||
8094|012|B|||
8094|013|C|COMMON BRAND NAME(S): Ritalin-SR||
8094|014|B|||
8094|015|W|WARNING:  Misuse or abuse of methylphenidate can result in||
8094|016|W|serious (possibly fatal) heart and blood pressure problems.||
8094|017|W|   This medication can be habit-forming and should be used||
8094|018|W|cautiously by people who have mental/mood disorders or a||
8094|019|W|substance use disorder (such as overuse of or addiction to||
8094|020|W|drugs/alcohol). Before using this medication, tell your doctor if||
8094|021|W|you have a personal or family history of a substance use||
8094|022|W|disorder. Do not increase your dose, use it more often, or use it||
8094|023|W|for a longer time or in a different way than prescribed. Doing so||
8094|024|W|may result in a decrease in the effect of this drug, drug||
8094|025|W|dependence, or abnormal thoughts/behavior.||
8094|026|W|   Your doctor may monitor you for a while after the medication||
8094|027|W|is stopped, especially if you have taken this drug for a long||
8094|028|W|time or in high doses. (See also How to Use section.)||
8094|029|B|||
8094|030|U|USES:  This medication is used to treat attention deficit||
8094|031|U|hyperactivity disorder - ADHD. It works by changing the amounts||
8094|032|U|of certain natural substances in the brain. Methylphenidate||
8094|033|U|belongs to a class of drugs known as stimulants. It can help||
8094|034|U|increase your ability to pay attention, stay focused on an||
8094|035|U|activity, and control behavior problems. It may also help you to||
8094|036|U|organize your tasks and improve listening skills.||
8094|037|U|   This medication is also used to treat a certain sleep disorder||
8094|038|U|(narcolepsy).||
8094|039|B|||
8094|040|H|HOW TO USE:  Read the Medication Guide provided by your||
8094|041|H|pharmacist before you start taking methylphenidate and each time||
8094|042|H|you get a refill. If you have any questions, ask your doctor or||
8094|043|H|pharmacist.||
8094|044|H|   Take this medication by mouth as directed by your doctor,||
8094|045|H|usually once or twice a day. This medication is best taken 30 to||
8094|046|H|45 minutes before a meal. However, if you have stomach upset, you||
8094|047|H|may take this medication with or after a meal or snack. Taking||
8094|048|H|this medication late in the day may cause trouble sleeping||
8094|049|H|(insomnia).||
8094|050|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
8094|051|H|Doing so can release all of the drug at once, increasing the risk||
8094|052|H|of side effects.||
8094|053|H|   Take this medication regularly to get the most benefit from||
8094|054|H|it. To help you remember, take it at the same times each day.||
8094|055|H|   The dosage is based on your medical condition and response to||
8094|056|H|treatment. Your doctor may direct you to gradually increase or||
8094|057|H|decrease your dose. Also, if you have used it for a long time, do||
8094|058|H|not suddenly stop using this drug without consulting your doctor.||
8094|059|H|   If you suddenly stop using this medication, you may have||
8094|060|H|withdrawal symptoms (such as depression, suicidal thoughts, or||
8094|061|H|other mental/mood changes). To help prevent withdrawal, your||
8094|062|H|doctor may lower your dose slowly. Withdrawal is more likely if||
8094|063|H|you have used methylphenidate for a long time or in high doses.||
8094|064|H|Tell your doctor or pharmacist right away if you have withdrawal.||
8094|065|H|   When used for a long time, this medication may not work as||
8094|066|H|well. Talk with your doctor if this medication stops working||
8094|067|H|well.||
8094|068|H|   Though it helps many people, this medication may sometimes||
8094|069|H|cause addiction. This risk may be higher if you have a substance||
8094|070|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
8094|071|H|Take this medication exactly as prescribed to lower the risk of||
8094|072|H|addiction. Ask your doctor or pharmacist for more details.||
8094|073|H|   Tell your doctor if your condition does not get better or if||
8094|074|H|it gets worse.||
8094|075|B|||
8094|076|S|SIDE EFFECTS:  Nervousness, trouble sleeping, loss of appetite,||
8094|077|S|weight loss, dizziness, nausea, vomiting, or headache may occur.||
8094|078|S|If any of these effects last or get worse, tell your doctor or||
8094|079|S|pharmacist promptly.||
8094|080|S|   Remember that this medication has been prescribed because your||
8094|081|S|doctor has judged that the benefit to you is greater than the||
8094|082|S|risk of side effects. Many people using this medication do not||
8094|083|S|have serious side effects.||
8094|084|S|   This medication may raise your blood pressure. Check your||
8094|085|S|blood pressure regularly and tell your doctor if the results are||
8094|086|S|high.||
8094|087|S|   Tell your doctor right away if you have any serious side||
8094|088|S|effects, including: signs of blood flow problems in the fingers||
8094|089|S|or toes (such as coldness, numbness, pain, or skin color||
8094|090|S|changes), unusual wounds on the fingers or toes,||
8094|091|S|fast/pounding/irregular heartbeat, mental/mood/behavior changes||
8094|092|S|(such as agitation, aggression, mood swings, abnormal thoughts,||
8094|093|S|thoughts of suicide), uncontrolled muscle movements (such as||
8094|094|S|twitching, shaking), sudden outbursts of words/sounds that are||
8094|095|S|hard to control, vision changes (such as blurred vision).||
8094|096|S|   Get medical help right away if you have any very serious side||
8094|097|S|effects, including: fainting, seizure, symptoms of a heart attack||
8094|098|S|(such as chest/jaw/left arm pain, shortness of breath, unusual||
8094|099|S|sweating), symptoms of a stroke (such as weakness on one side of||
8094|100|S|the body, trouble speaking, sudden vision changes, confusion).||
8094|101|S|   Rarely, males (including young boys and teens) may have a||
8094|102|S|painful or prolonged erection lasting 4 or more hours while using||
8094|103|S|this medication. Caregivers/parents should also be watchful for||
8094|104|S|this serious side effect in boys. If a painful or prolonged||
8094|105|S|erection occurs, stop using this drug and get medical help right||
8094|106|S|away, or permanent problems could occur. Ask your doctor or||
8094|107|S|pharmacist for more details.||
8094|108|S|   A very serious allergic reaction to this drug is rare.||
8094|109|S|However, get medical help right away if you notice any symptoms||
8094|110|S|of a serious allergic reaction, including: rash, itching/swelling||
8094|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8094|112|S|breathing.||
8094|113|S|   This is not a complete list of possible side effects. If you||
8094|114|S|notice other effects not listed above, contact your doctor or||
8094|115|S|pharmacist.||
8094|116|S|   In the US -||
8094|117|S|   Call your doctor for medical advice about side effects. You||
8094|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8094|119|S|www.fda.gov/medwatch.||
8094|120|S|   In Canada - Call your doctor for medical advice about side||
8094|121|S|effects. You may report side effects to Health Canada at||
8094|122|S|1-866-234-2345.||
8094|123|B|||
8094|124|P|PRECAUTIONS:  See also Warning section.||
8094|125|P|   Before taking methylphenidate, tell your doctor or pharmacist||
8094|126|P|if you are allergic to it; or to dexmethylphenidate; or if you||
8094|127|P|have any other allergies. This product may contain inactive||
8094|128|P|ingredients, which can cause allergic reactions or other||
8094|129|P|problems. Talk to your pharmacist for more details.||
8094|130|P|   Before using this medication, tell your doctor or pharmacist||
8094|131|P|your medical history, especially of: high blood pressure, blood||
8094|132|P|circulation problems (such as Raynaud's disease), glaucoma, heart||
8094|133|P|problems (such as irregular heartbeat, heart failure, previous||
8094|134|P|heart attack, problems with heart structure), family history of||
8094|135|P|heart problems (such as sudden cardiac death, irregular||
8094|136|P|heartbeat), mental/mood conditions (especially anxiety, tension,||
8094|137|P|agitation), personal/family history of mental/mood disorders||
8094|138|P|(such as bipolar disorder, depression, psychosis, suicidal||
8094|139|P|thoughts), personal/family history of uncontrolled muscle||
8094|140|P|movements (motor tics, Tourette's syndrome), overactive thyroid||
8094|141|P|(hyperthyroidism), seizure disorder.||
8094|142|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8094|143|P|can make you more dizzy. Do not drive, use machinery, or do||
8094|144|P|anything that needs alertness until you can do it safely. Limit||
8094|145|P|alcoholic beverages. Talk to your doctor if you are using||
8094|146|P|marijuana (cannabis).||
8094|147|P|   Before having surgery, tell your doctor or dentist about all||
8094|148|P|the products you use (including prescription drugs,||
8094|149|P|nonprescription drugs, and herbal products).||
8094|150|P|   Children (especially those younger than 6) may be more||
8094|151|P|sensitive to the side effects of this drug, especially weight||
8094|152|P|loss. If used for a long time, this drug may affect a child's||
8094|153|P|growth rate, weight, and final adult height. To reduce the risk,||
8094|154|P|the doctor may recommend briefly stopping the medication from||
8094|155|P|time to time. Check the child's weight and height regularly, and||
8094|156|P|consult your doctor or pharmacist for more details.||
8094|157|P|   Older adults may be more sensitive to the side effects of this||
8094|158|P|drug, especially trouble sleeping, weight loss, or chest pain.||
8094|159|P|   During pregnancy, methylphenidate should be used only when||
8094|160|P|clearly needed. Discuss the risks and benefits with your doctor.||
8094|161|P|   This medication passes into breast milk. Consult your doctor||
8094|162|P|before breastfeeding.||
8094|163|B|||
8094|164|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8094|165|I|medications work or increase your risk for serious side effects.||
8094|166|I|This document does not contain all possible drug interactions.||
8094|167|I|Keep a list of all the products you use (including||
8094|168|I|prescription/nonprescription drugs and herbal products) and share||
8094|169|I|it with your doctor and pharmacist. Do not start, stop, or change||
8094|170|I|the dosage of any medicines without your doctor's approval.||
8094|171|I|   Taking MAO inhibitors with this medication may cause a serious||
8094|172|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
8094|173|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8094|174|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8094|175|I|selegiline, tranylcypromine) during treatment with this||
8094|176|I|medication. Most MAO inhibitors should also not be taken for two||
8094|177|I|weeks before treatment with this medication. Ask your doctor when||
8094|178|I|to start or stop taking this medication.||
8094|179|I|   Methylphenidate is very similar to dexmethylphenidate. Do not||
8094|180|I|use medications containing dexmethylphenidate while using||
8094|181|I|methylphenidate.||
8094|182|I|   This medication may interfere with certain medical/lab tests||
8094|183|I|(such as brain scan for Parkinson's disease), possibly causing||
8094|184|I|false test results. Make sure lab personnel and all your doctors||
8094|185|I|know you use this drug.||
8094|186|B|||
8094|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8094|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8094|189|O|poison control center right away. US residents can call||
8094|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8094|191|O|Symptoms of overdose may include: vomiting, agitation, confusion,||
8094|192|O|sweating, flushing, muscle twitching, hallucinations, seizures,||
8094|193|O|loss of consciousness.||
8094|194|B|||
8094|195|N|NOTES:  Do not share this medication with others. Sharing it is||
8094|196|N|against the law.||
8094|197|N|   Lab and/or medical tests (such as blood pressure, complete||
8094|198|N|blood count, height/weight monitoring in children) may be done||
8094|199|N|while you are taking this medication. Keep all medical and lab||
8094|200|N|appointments. Consult your doctor for more details.||
8094|201|N|   There are different brands and forms of this medication||
8094|202|N|available. Not all have the same effects. Do not change brands or||
8094|203|N|forms without consulting your doctor or pharmacist.||
8094|204|B|||
8094|205|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8094|206|D|remember. If it is near bedtime or near the time of the next||
8094|207|D|dose, skip the missed dose. Take your next dose at the regular||
8094|208|D|time. Do not double the dose to catch up.||
8094|209|B|||
8094|210|R|STORAGE:  Different brands of this medication have different||
8094|211|R|storage needs. Check the product package for instructions on how||
8094|212|R|to store your brand, or ask your pharmacist. Do not store in the||
8094|213|R|bathroom. Keep all medications away from children and pets.||
8094|214|R|   Do not flush medications down the toilet or pour them into a||
8094|215|R|drain unless instructed to do so. Properly discard this product||
8094|216|R|when it is expired or no longer needed. Consult your pharmacist||
8094|217|R|or local waste disposal company.||
8094|218|B|||
8094|219|A|Information last revised July 2025.||
8094|220|A|Copyright(c) 2025 First Databank, Inc.||
8094|221|B|||
8095|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8095|002|Z|does NOT have all possible information about this product. This||
8095|003|Z|information does not assure that this product is safe, effective,||
8095|004|Z|or appropriate for you. This information is not individual||
8095|005|Z|medical advice and does not substitute for the advice of your||
8095|006|Z|health care professional. Always ask your health care||
8095|007|Z|professional for complete information about this product and your||
8095|008|Z|specific health needs.||
8095|009|B|||
8095|010|T|SERTRALINE - ORAL||
8095|011|F|(SER-truh-leen)||
8095|012|B|||
8095|013|C|COMMON BRAND NAME(S): Zoloft||
8095|014|B|||
8095|015|W|WARNING:  Antidepressant medications are used to treat a variety||
8095|016|W|of conditions, including depression and other mental/mood||
8095|017|W|disorders. These medications can help prevent suicidal||
8095|018|W|thoughts/attempts and provide other important benefits. However,||
8095|019|W|a small number of people (especially people younger than 25) who||
8095|020|W|take antidepressants for any condition may experience worsening||
8095|021|W|depression, other mental/mood symptoms, or suicidal||
8095|022|W|thoughts/attempts. It is very important to talk with the doctor||
8095|023|W|about the risks and benefits of antidepressant medication||
8095|024|W|(especially for people younger than 25), even if treatment is not||
8095|025|W|for a mental/mood condition.||
8095|026|W|   Tell the doctor right away if you notice worsening||
8095|027|W|depression/other psychiatric conditions, unusual behavior changes||
8095|028|W|(including possible suicidal thoughts/attempts), or other||
8095|029|W|mental/mood changes (including new/worsening anxiety, panic||
8095|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
8095|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
8095|032|W|especially watchful for these symptoms when a new antidepressant||
8095|033|W|is started or when the dose is changed.||
8095|034|B|||
8095|035|U|USES:  This medication is used to treat certain mental/mood||
8095|036|U|disorders (such as depression, panic attacks, obsessive||
8095|037|U|compulsive disorder, post-traumatic stress disorder, social||
8095|038|U|anxiety disorder). It is also used to treat a severe form of||
8095|039|U|premenstrual syndrome (premenstrual dysphoric disorder).||
8095|040|U|Sertraline belongs to a class of drugs known as selective||
8095|041|U|serotonin reuptake inhibitors (SSRIs). It works by helping to||
8095|042|U|restore the balance of a certain natural substance (serotonin) in||
8095|043|U|the brain.||
8095|044|B|||
8095|045|V|OTHER USES:  This section contains uses of this drug that are not||
8095|046|V|listed in the approved professional labeling for the drug but||
8095|047|V|that may be prescribed by your health care professional. Use this||
8095|048|V|drug for a condition that is listed in this section only if it||
8095|049|V|has been so prescribed by your health care professional.||
8095|050|V|   This drug may also be used for binge eating disorder (BED).||
8095|051|B|||
8095|052|H|HOW TO USE:  Read the Medication Guide and, if available, the||
8095|053|H|Patient Information Leaflet provided by your pharmacist before||
8095|054|H|you start using sertraline and each time you get a refill. If you||
8095|055|H|have any questions, ask your doctor or pharmacist.||
8095|056|H|   Take this medication by mouth as directed by your doctor,||
8095|057|H|usually once daily either in the morning or evening. The tablet||
8095|058|H|or liquid form of this medication may be taken with or without||
8095|059|H|food.||
8095|060|H|   The 25 milligrams, 50 milligrams, and 100 milligrams capsule||
8095|061|H|is usually taken with food. The 150 milligrams and 200 milligrams||
8095|062|H|capsule may be taken with or without food. Swallow the capsules||
8095|063|H|whole. Do not crush or chew the capsules. If you have any||
8095|064|H|questions about how to take the capsule form of this medication,||
8095|065|H|ask your doctor or pharmacist.||
8095|066|H|   The liquid form of this medication must be mixed with another||
8095|067|H|liquid before use. Just before taking, carefully measure the dose||
8095|068|H|using the medicine dropper provided. Do not use a household spoon||
8095|069|H|because you may not get the correct dose. Mix the dose with a||
8095|070|H|half cup (4 ounces/120 milliliters) of water, ginger ale,||
8095|071|H|lemon-lime soda, lemonade, or orange juice. Do not use other||
8095|072|H|liquids to mix this drug. The mixture may appear cloudy, which is||
8095|073|H|normal and harmless. Drink all of the mixture right away. Do not||
8095|074|H|prepare a supply in advance.||
8095|075|H|   If you are taking this medication for premenstrual problems,||
8095|076|H|your doctor may direct you to take this drug every day of the||
8095|077|H|month or for only the 2 weeks before your period until the start||
8095|078|H|of your period.||
8095|079|H|   The dosage is based on your medical condition and response to||
8095|080|H|treatment. To reduce your risk of side effects, your doctor may||
8095|081|H|direct you to start this medication at a low dose and gradually||
8095|082|H|increase your dose. Follow your doctor's instructions carefully.||
8095|083|H|Take this medication regularly to get the most benefit from it.||
8095|084|H|To help you remember, take it at the same time each day.||
8095|085|H|   Keep taking this medication even if you feel well. Do not stop||
8095|086|H|taking this medication without consulting your doctor. Some||
8095|087|H|conditions may become worse when this drug is suddenly stopped.||
8095|088|H|Also, you may experience symptoms such as mood swings, headache,||
8095|089|H|tiredness, sleep changes, and brief feelings similar to electric||
8095|090|H|shock. To prevent these symptoms while you are stopping treatment||
8095|091|H|with this drug, your doctor may reduce your dose gradually.||
8095|092|H|Report any new or worsening symptoms right away.||
8095|093|H|   Tell your doctor if your condition lasts or gets worse.||
8095|094|B|||
8095|095|S|SIDE EFFECTS:  See also Warning section.||
8095|096|S|   Nausea, dizziness, drowsiness, dry mouth, loss of appetite,||
8095|097|S|increased sweating, diarrhea, upset stomach, or trouble sleeping||
8095|098|S|may occur. If any of these effects last or get worse, tell your||
8095|099|S|doctor or pharmacist promptly.||
8095|100|S|   Remember that this medication has been prescribed because your||
8095|101|S|doctor has judged that the benefit to you is greater than the||
8095|102|S|risk of side effects. Many people using this medication do not||
8095|103|S|have serious side effects.||
8095|104|S|   Tell your doctor right away if you have any serious side||
8095|105|S|effects, including: easy bleeding/bruising, decreased interest in||
8095|106|S|sex, changes in sexual ability, muscle cramps/weakness, shaking||
8095|107|S|(tremor), unusual weight loss.||
8095|108|S|   Get medical help right away if you have any very serious side||
8095|109|S|effects, including: fast/irregular heartbeat, fainting, black||
8095|110|S|stools, vomit that looks like coffee grounds, eye||
8095|111|S|pain/swelling/redness, widened pupils, vision changes (such as||
8095|112|S|seeing rainbows around lights at night, blurred vision).||
8095|113|S|   This medication may increase serotonin and rarely cause a very||
8095|114|S|serious condition called serotonin syndrome/toxicity. The risk||
8095|115|S|increases if you are also taking other drugs that increase||
8095|116|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
8095|117|S|take (see Drug Interactions section). Get medical help right away||
8095|118|S|if you develop some of the following symptoms: fast heartbeat,||
8095|119|S|hallucinations, loss of coordination, severe dizziness, severe||
8095|120|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
8095|121|S|unusual agitation/restlessness.||
8095|122|S|   Rarely, males may have a painful or prolonged erection lasting||
8095|123|S|4 or more hours. If this occurs, stop using this drug and get||
8095|124|S|medical help right away, or permanent problems could occur.||
8095|125|S|   A very serious allergic reaction to this drug is rare.||
8095|126|S|However, get medical help right away if you notice any symptoms||
8095|127|S|of a serious allergic reaction, including: rash, itching/swelling||
8095|128|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8095|129|S|breathing.||
8095|130|S|   This is not a complete list of possible side effects. If you||
8095|131|S|notice other effects not listed above, contact your doctor or||
8095|132|S|pharmacist.||
8095|133|S|   In the US -||
8095|134|S|   Call your doctor for medical advice about side effects. You||
8095|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8095|136|S|www.fda.gov/medwatch.||
8095|137|S|   In Canada - Call your doctor for medical advice about side||
8095|138|S|effects. You may report side effects to Health Canada at||
8095|139|S|1-866-234-2345.||
8095|140|B|||
8095|141|P|PRECAUTIONS:  Before taking sertraline, tell your doctor or||
8095|142|P|pharmacist if you are allergic to it; or if you have any other||
8095|143|P|allergies. This product may contain inactive ingredients (such as||
8095|144|P|latex found in the medicine dropper, tartrazine found in some||
8095|145|P|brands), which can cause allergic reactions or other problems.||
8095|146|P|Talk to your pharmacist for more details.||
8095|147|P|   Before using this medication, tell your doctor or pharmacist||
8095|148|P|your medical history, especially of: personal or family history||
8095|149|P|of bipolar/manic-depressive disorder, bleeding problems, liver||
8095|150|P|disease, seizure disorder, thyroid disease, personal or family||
8095|151|P|history of glaucoma (angle-closure type).||
8095|152|P|   Sertraline may cause a condition that affects the heart rhythm||
8095|153|P|(QT prolongation). QT prolongation can rarely cause serious||
8095|154|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
8095|155|P|as severe dizziness, fainting) that need medical attention right||
8095|156|P|away.||
8095|157|P|   The risk of QT prolongation may be increased if you have||
8095|158|P|certain medical conditions or are taking other drugs that may||
8095|159|P|cause QT prolongation. Before using sertraline, tell your doctor||
8095|160|P|or pharmacist of all the drugs you take and if you have any of||
8095|161|P|the following conditions: certain heart problems (heart failure,||
8095|162|P|slow heartbeat, QT prolongation in the EKG), family history of||
8095|163|P|certain heart problems (QT prolongation in the EKG, sudden||
8095|164|P|cardiac death).||
8095|165|P|   Low levels of potassium or magnesium in the blood may also||
8095|166|P|increase your risk of QT prolongation. This risk may increase if||
8095|167|P|you use certain drugs (such as diuretics/"water pills") or if you||
8095|168|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8095|169|P|Talk to your doctor about using sertraline safely.||
8095|170|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8095|171|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8095|172|P|machinery, or do anything that needs alertness until you can do||
8095|173|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
8095|174|P|are using marijuana (cannabis).||
8095|175|P|   The liquid form of this medication contains alcohol. Caution||
8095|176|P|is advised if you have diabetes, alcohol dependence, or liver||
8095|177|P|disease. Some medications (such as metronidazole, disulfiram) can||
8095|178|P|cause a serious reaction when combined with alcohol. Ask your||
8095|179|P|doctor or pharmacist about using this product safely.||
8095|180|P|   Before having surgery, tell your doctor or dentist about all||
8095|181|P|the products you use (including prescription drugs,||
8095|182|P|nonprescription drugs, and herbal products).||
8095|183|P|   Older adults may be more sensitive to the side effects of this||
8095|184|P|drug, especially bleeding, loss of coordination, or QT||
8095|185|P|prolongation (see above). Loss of coordination can increase the||
8095|186|P|risk of falling. Older adults may also be more likely to develop||
8095|187|P|a type of salt imbalance (hyponatremia), especially if they are||
8095|188|P|taking "water pills" (diuretics).||
8095|189|P|   Children may be more sensitive to the side effects of the||
8095|190|P|drug, especially loss of appetite and weight loss. Monitor weight||
8095|191|P|and height in children who are taking this drug.||
8095|192|P|   During pregnancy, this medication should be used only when||
8095|193|P|clearly needed. It may harm an unborn baby. Also, babies born to||
8095|194|P|mothers who have used this drug during the last 3 months of||
8095|195|P|pregnancy may rarely develop withdrawal symptoms such as||
8095|196|P|feeding/breathing difficulties, seizures, muscle stiffness, or||
8095|197|P|constant crying. If you notice any of these symptoms in your||
8095|198|P|newborn, tell the doctor promptly.||
8095|199|P|   Since untreated mental/mood problems (such as depression,||
8095|200|P|panic attacks, obsessive compulsive disorder, post-traumatic||
8095|201|P|stress disorder) can be a serious condition, do not stop taking||
8095|202|P|this medication unless directed by your doctor. If you are||
8095|203|P|planning pregnancy, become pregnant, or think you may be||
8095|204|P|pregnant, discuss with your doctor right away the benefits and||
8095|205|P|risks of using this medication during pregnancy.||
8095|206|P|   This drug passes into breast milk. Consult your doctor before||
8095|207|P|breastfeeding.||
8095|208|B|||
8095|209|I|DRUG INTERACTIONS:  See also Precautions section.||
8095|210|I|   Drug interactions may change how your medications work or||
8095|211|I|increase your risk for serious side effects. This document does||
8095|212|I|not contain all possible drug interactions. Keep a list of all||
8095|213|I|the products you use (including prescription/nonprescription||
8095|214|I|drugs and herbal products) and share it with your doctor and||
8095|215|I|pharmacist. Do not start, stop, or change the dosage of any||
8095|216|I|medicines without your doctor's approval.||
8095|217|I|   Some products that may interact with this drug are: pimozide,||
8095|218|I|other drugs that can cause bleeding/bruising (including||
8095|219|I|antiplatelet drugs such as clopidogrel, NSAIDs such as||
8095|220|I|ibuprofen/naproxen, "blood thinners" such as||
8095|221|I|dabigatran/warfarin).||
8095|222|I|   Taking MAO inhibitors with this medication may cause a serious||
8095|223|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
8095|224|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8095|225|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8095|226|I|selegiline, tranylcypromine) during treatment with this||
8095|227|I|medication. Most MAO inhibitors should also not be taken for two||
8095|228|I|weeks before and after treatment with this medication. Ask your||
8095|229|I|doctor when to start or stop taking this medication.||
8095|230|I|   The risk of serotonin syndrome/toxicity increases if you are||
8095|231|I|also taking other drugs that increase serotonin. Examples include||
8095|232|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
8095|233|I|antidepressants (including other SSRIs such as||
8095|234|I|fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine),||
8095|235|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
8095|236|I|may be more likely when you start or increase the dose of these||
8095|237|I|drugs.||
8095|238|I|   Tell your doctor or pharmacist if you are taking other||
8095|239|I|products that cause drowsiness such as alcohol, marijuana||
8095|240|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
8095|241|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
8095|242|I|zolpidem), muscle relaxants, and opioid pain or cough relievers||
8095|243|I|(such as codeine, hydrocodone).||
8095|244|I|   Check the labels on all your medicines (such as allergy or||
8095|245|I|cough-and-cold products) because they may contain ingredients||
8095|246|I|that cause drowsiness. Ask your pharmacist about using those||
8095|247|I|products safely.||
8095|248|I|   Aspirin can increase the risk of bleeding when used with this||
8095|249|I|medication. However, if your doctor has told you to take low-dose||
8095|250|I|aspirin to prevent heart attack or stroke (usually 81-162||
8095|251|I|milligrams a day), you should keep taking the aspirin unless your||
8095|252|I|doctor tells you not to.||
8095|253|I|   This medication may interfere with certain medical/lab tests||
8095|254|I|(including brain scan for Parkinson's disease), possibly causing||
8095|255|I|false test results. Make sure lab personnel and all your doctors||
8095|256|I|know you use this drug.||
8095|257|B|||
8095|258|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8095|259|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8095|260|O|poison control center right away. US residents can call||
8095|261|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8095|262|O|Symptoms of overdose may include: severe dizziness, fainting.||
8095|263|B|||
8095|264|N|NOTES:  Do not share this medication with others.||
8095|265|N|   Keep all medical and lab appointments.||
8095|266|B|||
8095|267|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8095|268|D|remember. If it is near the time of the next dose, skip the||
8095|269|D|missed dose. Take your next dose at the regular time. Do not||
8095|270|D|double the dose to catch up.||
8095|271|B|||
8095|272|R|STORAGE:  Store at room temperature away from light and moisture.||
8095|273|R|Do not store in the bathroom. Keep all medications away from||
8095|274|R|children and pets.||
8095|275|R|   Do not flush medications down the toilet or pour them into a||
8095|276|R|drain unless instructed to do so. Properly discard this product||
8095|277|R|when it is expired or no longer needed. Consult your pharmacist||
8095|278|R|or local waste disposal company.||
8095|279|B|||
8095|280|A|Information last revised February 2025.||
8095|281|A|Copyright(c) 2025 First Databank, Inc.||
8095|282|B|||
8099|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8099|002|Z|does NOT have all possible information about this product. This||
8099|003|Z|information does not assure that this product is safe, effective,||
8099|004|Z|or appropriate for you. This information is not individual||
8099|005|Z|medical advice and does not substitute for the advice of your||
8099|006|Z|health care professional. Always ask your health care||
8099|007|Z|professional for complete information about this product and your||
8099|008|Z|specific health needs.||
8099|009|B|||
8099|010|T|TROPICAMIDE - OPHTHALMIC||
8099|011|F|(tro-PICK-uh-mide)||
8099|012|B|||
8099|013|C|COMMON BRAND NAME(S): Mydriacyl||
8099|014|B|||
8099|015|U|USES:  This medication is used to widen (dilate) the pupil of the||
8099|016|U|eye in preparation for certain eye examinations. It belongs to a||
8099|017|U|class of drugs known as anticholinergics. Tropicamide works by||
8099|018|U|relaxing certain eye muscles.||
8099|019|B|||
8099|020|V|OTHER USES:  This section contains uses of this drug that are not||
8099|021|V|listed in the approved professional labeling for the drug but||
8099|022|V|that may be prescribed by your health care professional. Use this||
8099|023|V|drug for a condition that is listed in this section only if it||
8099|024|V|has been so prescribed by your health care professional.||
8099|025|V|   This drug may also be used for swelling in different parts of||
8099|026|V|the eye (such as iritis, iridocyclitis, keratitis).||
8099|027|B|||
8099|028|H|HOW TO USE:  Use this medication in the eye(s) as directed by||
8099|029|H|your doctor, usually 15 to 20 minutes before an eye examination.||
8099|030|H|   To apply eye drops, wash your hands first. To avoid||
8099|031|H|contamination, do not touch the dropper tip or let it touch your||
8099|032|H|eye or any other surface.||
8099|033|H|   If you are wearing contact lenses, remove them before using||
8099|034|H|this medication. Ask your doctor when you may replace your||
8099|035|H|contact lenses.||
8099|036|H|   Tilt your head back, look upward, and pull down the lower||
8099|037|H|eyelid to make a pouch. Hold the dropper directly over your eye||
8099|038|H|and place 1 or 2 drops into the pouch. Look downward and gently||
8099|039|H|close your eyes for 1 to 2 minutes. Place one finger at the||
8099|040|H|corner of your eye (near the nose) and apply gentle pressure for||
8099|041|H|2 to 3 minutes. This will prevent the medication from draining||
8099|042|H|out and being absorbed by your body. Try not to blink and do not||
8099|043|H|rub your eye. Repeat these steps for your other eye if so||
8099|044|H|directed.||
8099|045|H|   Do not rinse the dropper. Replace the dropper cap after each||
8099|046|H|use.||
8099|047|H|   If you are using another kind of eye medication (such as drops||
8099|048|H|or ointments), wait at least 5 to 10 minutes before applying||
8099|049|H|other medications. Use eye drops before eye ointments to allow||
8099|050|H|the drops to enter the eye.||
8099|051|H|   Wash your hands after using this medication. If giving this||
8099|052|H|medication to a child, do not let the medication get into the||
8099|053|H|child's mouth. Also wash the child's hands after giving this||
8099|054|H|medication.||
8099|055|B|||
8099|056|S|SIDE EFFECTS:  Eye stinging, temporary blurred vision, dry mouth,||
8099|057|S|or eye sensitivity to light may occur. If any of these effects||
8099|058|S|last or get worse, tell your doctor or pharmacist promptly.||
8099|059|S|   Remember that this medication has been prescribed because your||
8099|060|S|doctor has judged that the benefit to you is greater than the||
8099|061|S|risk of side effects. Many people using this medication do not||
8099|062|S|have serious side effects.||
8099|063|S|   Tell your doctor right away if you have any serious side||
8099|064|S|effects, including: feeling as if something is in the eye, fast||
8099|065|S|heartbeat, muscle stiffness, mental/mood changes.||
8099|066|S|   Get medical help right away if you have any very serious side||
8099|067|S|effects, including: eye pain/swelling/redness, vision changes||
8099|068|S|(such as seeing rainbows around lights at night).||
8099|069|S|   A very serious allergic reaction to this drug is rare.||
8099|070|S|However, get medical help right away if you notice any symptoms||
8099|071|S|of a serious allergic reaction, including: rash, itching/swelling||
8099|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8099|073|S|breathing.||
8099|074|S|   This is not a complete list of possible side effects. If you||
8099|075|S|notice other effects not listed above, contact your doctor or||
8099|076|S|pharmacist.||
8099|077|S|   In the US -||
8099|078|S|   Call your doctor for medical advice about side effects. You||
8099|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8099|080|S|www.fda.gov/medwatch.||
8099|081|S|   In Canada - Call your doctor for medical advice about side||
8099|082|S|effects. You may report side effects to Health Canada at||
8099|083|S|1-866-234-2345.||
8099|084|B|||
8099|085|P|PRECAUTIONS:  Before using tropicamide, tell your doctor or||
8099|086|P|pharmacist if you are allergic to it; or if you have any other||
8099|087|P|allergies. This product may contain inactive ingredients, which||
8099|088|P|can cause allergic reactions or other problems. Talk to your||
8099|089|P|pharmacist for more details.||
8099|090|P|   Before using this medication, tell your doctor or pharmacist||
8099|091|P|your medical history, especially of: personal or family history||
8099|092|P|of glaucoma (angle-closure type), high blood pressure, overactive||
8099|093|P|thyroid (hyperthyroidism), diabetes, heart disease (such as||
8099|094|P|irregular heart rhythm, coronary artery disease), Down syndrome,||
8099|095|P|brain damage or spastic paralysis (in children).||
8099|096|P|   After you apply this drug, your vision may become temporarily||
8099|097|P|blurred. Do not drive, use machinery, or do anything that needs||
8099|098|P|clear vision until you can do it safely.||
8099|099|P|   This medication may make your eyes more sensitive to light.||
8099|100|P|Protect your eyes in bright light. Use dark sunglasses when||
8099|101|P|outdoors.||
8099|102|P|   Older adults may be more sensitive to the side effects of this||
8099|103|P|drug, especially mental/mood changes (such as agitation).||
8099|104|P|   Children may be more sensitive to the side effects of this||
8099|105|P|drug, especially mental/mood changes (such as agitation).||
8099|106|P|   During pregnancy, this medication should be used only when||
8099|107|P|clearly needed. Discuss the risks and benefits with your doctor.||
8099|108|P|   It is unknown if this drug passes into breast milk. Consult||
8099|109|P|your doctor before breastfeeding.||
8099|110|B|||
8099|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8099|112|I|medications work or increase your risk for serious side effects.||
8099|113|I|This document does not contain all possible drug interactions.||
8099|114|I|Keep a list of all the products you use (including||
8099|115|I|prescription/nonprescription drugs and herbal products) and share||
8099|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
8099|117|I|the dosage of any medicines without your doctor's approval.||
8099|118|B|||
8099|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8099|120|O|has overdosed and has serious symptoms such as passing out or||
8099|121|O|trouble breathing, call 911. Otherwise, call a poison control||
8099|122|O|center right away. US residents can call 1-800-222-1222. Canada||
8099|123|O|residents can call 1-844-764-7669.||
8099|124|B|||
8099|125|N|NOTES:  Do not share this medication with others.||
8099|126|B|||
8099|127|D|MISSED DOSE:  Not applicable.||
8099|128|B|||
8099|129|R|STORAGE:  Store at room temperature away from light. Do not||
8099|130|R|refrigerate. Keep all medications away from children and pets.||
8099|131|R|   Do not flush medications down the toilet or pour them into a||
8099|132|R|drain unless instructed to do so. Properly discard this product||
8099|133|R|when it is expired or no longer needed. Consult your pharmacist||
8099|134|R|or local waste disposal company.||
8099|135|B|||
8099|136|A|Information last revised May 2024.||
8099|137|A|Copyright(c) 2025 First Databank, Inc.||
8099|138|B|||
8102|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8102|002|Z|does NOT have all possible information about this product. This||
8102|003|Z|information does not assure that this product is safe, effective,||
8102|004|Z|or appropriate for you. This information is not individual||
8102|005|Z|medical advice and does not substitute for the advice of your||
8102|006|Z|health care professional. Always ask your health care||
8102|007|Z|professional for complete information about this product and your||
8102|008|Z|specific health needs.||
8102|009|B|||
8102|010|T|TRIFLURIDINE DROPS - OPHTHALMIC||
8102|011|F|(try-FLEWR-ih-deen)||
8102|012|B|||
8102|013|C|COMMON BRAND NAME(S): Viroptic||
8102|014|B|||
8102|015|U|USES:  This medication is used to treat herpes infection of the||
8102|016|U|eye. Herpes is a virus that lives in the body quietly until an||
8102|017|U|outbreak is triggered. Trifluridine is not a cure for the||
8102|018|U|infection, but treatment of an outbreak can speed up the healing||
8102|019|U|of the sores/swelling in the eye and lower the risk of||
8102|020|U|complications (such as vision loss).||
8102|021|B|||
8102|022|V|OTHER USES:  This section contains uses of this drug that are not||
8102|023|V|listed in the approved professional labeling for the drug but||
8102|024|V|that may be prescribed by your health care professional. Use this||
8102|025|V|drug for a condition that is listed in this section only if it||
8102|026|V|has been so prescribed by your health care professional.||
8102|027|V|   This drug may also be used for other eye infections caused by||
8102|028|V|viruses (such as vaccinia virus infections).||
8102|029|B|||
8102|030|H|HOW TO USE:  Use this medication in the affected eye(s) as||
8102|031|H|directed by your doctor, usually every 2 hours while awake until||
8102|032|H|the eye has healed.||
8102|033|H|   To apply eye drops, wash your hands first. To avoid||
8102|034|H|contamination, do not touch the dropper tip or let it touch your||
8102|035|H|eye or any other surface.||
8102|036|H|   Tilt your head back, look up, and pull down the lower eyelid||
8102|037|H|to make a pouch. Hold the dropper directly over your eye and||
8102|038|H|place 1 drop into the pouch as directed by your doctor. Look down||
8102|039|H|and gently close your eyes for 1 to 2 minutes. Place one finger||
8102|040|H|at the corner of your eye (near the nose) and press gently. This||
8102|041|H|will prevent the medication from draining out. Try not to blink||
8102|042|H|and do not rub your eye. Repeat these steps for your other eye if||
8102|043|H|so directed.||
8102|044|H|   Do not rinse the dropper. Replace the dropper cap after each||
8102|045|H|use.||
8102|046|H|   Do not use more than 9 drops into the eye in a 24-hour period.||
8102|047|H|After healing, use this medication for another 7 days, usually||
8102|048|H|every 4 hours while awake (at least 5 drops per day).||
8102|049|H|   If you are using another kind of eye medication (such as drops||
8102|050|H|or ointments), wait at least 5 to 10 minutes before applying||
8102|051|H|other medications. Use eye drops before eye ointments to allow||
8102|052|H|the drops to enter the eye.||
8102|053|H|   Wait several minutes for your vision to clear before driving||
8102|054|H|or operating machinery.||
8102|055|H|   Use this medication regularly in order to get the most benefit||
8102|056|H|from it. To help you remember, use it at the same times each day.||
8102|057|H|Keep using it for the full time prescribed. Stopping the||
8102|058|H|medication too early may result in a return of the infection.||
8102|059|H|   Do not use this medication more often or use longer than||
8102|060|H|prescribed because doing so may increase the risk of side||
8102|061|H|effects. This medication should not be used for more than 21 days||
8102|062|H|at a time.||
8102|063|H|   Tell your doctor if your condition gets worse, does not get||
8102|064|H|better after 7 days, or does not completely heal after 14 days.||
8102|065|B|||
8102|066|S|SIDE EFFECTS:  Temporary mild burning, stinging, and irritation||
8102|067|S|may occur. If any of these effects last or get worse, tell your||
8102|068|S|doctor or pharmacist promptly.||
8102|069|S|   Remember that this medication has been prescribed because your||
8102|070|S|doctor has judged that the benefit to you is greater than the||
8102|071|S|risk of side effects. Many people using this medication do not||
8102|072|S|have serious side effects.||
8102|073|S|   Tell your doctor right away if you have any serious side||
8102|074|S|effects, including: swelling eyelids, eye pain/redness, feeling||
8102|075|S|as if something is in the eye, vision changes.||
8102|076|S|   A very serious allergic reaction to this drug is rare.||
8102|077|S|However, get medical help right away if you notice any symptoms||
8102|078|S|of a serious allergic reaction, including: rash, itching/swelling||
8102|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8102|080|S|breathing.||
8102|081|S|   This is not a complete list of possible side effects. If you||
8102|082|S|notice other effects not listed above, contact your doctor or||
8102|083|S|pharmacist.||
8102|084|S|   In the US -||
8102|085|S|   Call your doctor for medical advice about side effects. You||
8102|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8102|087|S|www.fda.gov/medwatch.||
8102|088|S|   In Canada - Call your doctor for medical advice about side||
8102|089|S|effects. You may report side effects to Health Canada at||
8102|090|S|1-866-234-2345.||
8102|091|B|||
8102|092|P|PRECAUTIONS:  Before using trifluridine, tell your doctor or||
8102|093|P|pharmacist if you are allergic to it; or if you have any other||
8102|094|P|allergies. This product may contain inactive ingredients, which||
8102|095|P|can cause allergic reactions or other problems. Talk to your||
8102|096|P|pharmacist for more details.||
8102|097|P|   Before using this medication, tell your doctor or pharmacist||
8102|098|P|your medical history, especially of: other eye problems (such as||
8102|099|P|glaucoma).||
8102|100|P|   After you apply this drug, your vision may become temporarily||
8102|101|P|blurred. Do not drive, use machinery, or do anything that needs||
8102|102|P|clear vision until you can do it safely.||
8102|103|P|   During pregnancy, this medication should be used only when||
8102|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
8102|105|P|   It is unknown if this drug passes into breast milk. Consult||
8102|106|P|your doctor before breastfeeding.||
8102|107|B|||
8102|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8102|109|I|medications work or increase your risk for serious side effects.||
8102|110|I|This document does not contain all possible drug interactions.||
8102|111|I|Keep a list of all the products you use (including||
8102|112|I|prescription/nonprescription drugs and herbal products) and share||
8102|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
8102|114|I|the dosage of any medicines without your doctor's approval.||
8102|115|B|||
8102|116|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8102|117|O|has overdosed and has serious symptoms such as passing out or||
8102|118|O|trouble breathing, call 911. Otherwise, call a poison control||
8102|119|O|center right away. US residents can call 1-800-222-1222. Canada||
8102|120|O|residents can call 1-844-764-7669.||
8102|121|B|||
8102|122|N|NOTES:  Do not share this medication with others.||
8102|123|N|   This medication has been prescribed for your current condition||
8102|124|N|only. Do not use it later for another infection unless your||
8102|125|N|doctor tells you to.||
8102|126|N|   Lab and/or medical tests (such as eye exam) may be done while||
8102|127|N|you are using this medication. Keep all medical and lab||
8102|128|N|appointments. Consult your doctor for more details.||
8102|129|B|||
8102|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8102|131|D|If it is near the time of the next dose, skip the missed dose.||
8102|132|D|Use your next dose at the regular time. Do not double the dose to||
8102|133|D|catch up.||
8102|134|B|||
8102|135|R|STORAGE:  Store in the refrigerator away from light. Keep all||
8102|136|R|medications away from children and pets.||
8102|137|R|   Do not flush medications down the toilet or pour them into a||
8102|138|R|drain unless instructed to do so. Properly discard this product||
8102|139|R|when it is expired or no longer needed. Consult your pharmacist||
8102|140|R|or local waste disposal company.||
8102|141|B|||
8102|142|A|Information last revised November 2024.||
8102|143|A|Copyright(c) 2025 First Databank, Inc.||
8102|144|B|||
8104|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8104|002|Z|does NOT have all possible information about this product. This||
8104|003|Z|information does not assure that this product is safe, effective,||
8104|004|Z|or appropriate for you. This information is not individual||
8104|005|Z|medical advice and does not substitute for the advice of your||
8104|006|Z|health care professional. Always ask your health care||
8104|007|Z|professional for complete information about this product and your||
8104|008|Z|specific health needs.||
8104|009|B|||
8104|010|T|DORZOLAMIDE SOLUTION - OPHTHALMIC||
8104|011|F|(door-ZOHL-uh-mide)||
8104|012|B|||
8104|013|C|COMMON BRAND NAME(S): Trusopt||
8104|014|B|||
8104|015|U|USES:  Dorzolamide is used to treat high pressure inside the eye||
8104|016|U|due to glaucoma (open angle-type) or other eye diseases (such as||
8104|017|U|ocular hypertension). Lowering high pressure inside the eye helps||
8104|018|U|to prevent blindness. This medication works by decreasing the||
8104|019|U|amount of fluid within the eye. It belongs to a class of drugs||
8104|020|U|known as carbonic anhydrase inhibitors.||
8104|021|B|||
8104|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8104|023|H|from your pharmacist before you start using dorzolamide and each||
8104|024|H|time you get a refill. If you have any questions, ask your doctor||
8104|025|H|or pharmacist.||
8104|026|H|   Use this medication in the affected eye(s) as directed by your||
8104|027|H|doctor, usually one drop 3 times a day.||
8104|028|H|   To apply eye drops, wash your hands first. To avoid||
8104|029|H|contamination, do not touch the dropper tip or let it touch your||
8104|030|H|eye or any other surface.||
8104|031|H|   The preservative that may be found in some products may be||
8104|032|H|absorbed by contact lenses. If you wear contact lenses, remove||
8104|033|H|them before using the eye drops with preservative. Wait at least||
8104|034|H|15 minutes after using this medication before putting in your||
8104|035|H|contact lenses.||
8104|036|H|   Tilt your head back, look upward and pull down the lower||
8104|037|H|eyelid to make a pouch. Hold the dropper directly over your eye||
8104|038|H|and place one drop in your eye. Look downward and gently close||
8104|039|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
8104|040|H|your eye (near the nose) and apply gentle pressure. Try not to||
8104|041|H|blink and do not rub your eye. This will prevent the medication||
8104|042|H|from draining out. Repeat these steps for your other eye if so||
8104|043|H|directed.||
8104|044|H|   Do not rinse the dropper. Replace the dropper cap after each||
8104|045|H|use.||
8104|046|H|   If you are using another kind of eye medication (such as drops||
8104|047|H|or ointments), wait at least 5 minutes before applying other||
8104|048|H|medications. Use eye drops before eye ointments to allow the eye||
8104|049|H|drops to enter the eye.||
8104|050|H|   Wait several minutes for your vision to clear before driving||
8104|051|H|or operating machinery.||
8104|052|H|   Use this medication regularly in order to get the most benefit||
8104|053|H|from it. To help you remember, use it at the same times each day.||
8104|054|H|Keep using dorzolamide even if you feel well. Most people with||
8104|055|H|glaucoma or high pressure in the eyes do not feel sick.||
8104|056|B|||
8104|057|S|SIDE EFFECTS:  Temporary blurred vision, temporary||
8104|058|S|burning/stinging/itching/redness of the eye, watery eyes, dry||
8104|059|S|eyes, sensitivity of eyes to light, bitter taste, or headache may||
8104|060|S|occur. If any of these effects last or get worse, tell your||
8104|061|S|doctor or pharmacist promptly.||
8104|062|S|   Remember that this medication has been prescribed because your||
8104|063|S|doctor has judged that the benefit to you is greater than the||
8104|064|S|risk of side effects. Many people using this medication do not||
8104|065|S|have serious side effects.||
8104|066|S|   Tell your doctor right away if you have any serious side||
8104|067|S|effects, including: vision changes, signs of a kidney stone (such||
8104|068|S|as pain in the back/side/abdomen, nausea/vomiting, blood in the||
8104|069|S|urine), yellowing eyes/skin, dark urine, unusual||
8104|070|S|tiredness/weakness, easy bruising/bleeding, signs of infection||
8104|071|S|(such as sore throat that doesn't go away, fever, chills).||
8104|072|S|   Get medical help right away if you have any very serious side||
8104|073|S|effects, including: eye redness or discharge that doesn't stop,||
8104|074|S|eye or eyelid swelling, eye pain.||
8104|075|S|   A very serious allergic reaction to this drug is rare.||
8104|076|S|However, get medical help right away if you notice any symptoms||
8104|077|S|of a serious allergic reaction, including: rash, itching/swelling||
8104|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8104|079|S|breathing.||
8104|080|S|   This is not a complete list of possible side effects. If you||
8104|081|S|notice other effects not listed above, contact your doctor or||
8104|082|S|pharmacist.||
8104|083|S|   In the US -||
8104|084|S|   Call your doctor for medical advice about side effects. You||
8104|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8104|086|S|www.fda.gov/medwatch.||
8104|087|S|   In Canada - Call your doctor for medical advice about side||
8104|088|S|effects. You may report side effects to Health Canada at||
8104|089|S|1-866-234-2345.||
8104|090|B|||
8104|091|P|PRECAUTIONS:  Before using dorzolamide, tell your doctor or||
8104|092|P|pharmacist if you are allergic to it; or if you have any other||
8104|093|P|allergies. This product may contain inactive ingredients (such as||
8104|094|P|the preservative benzalkonium chloride), which can cause allergic||
8104|095|P|reactions or other problems. Talk to your pharmacist for more||
8104|096|P|details.||
8104|097|P|   Before using this medication, tell your doctor or pharmacist||
8104|098|P|your medical history, especially of: kidney disease, kidney||
8104|099|P|stones, liver disease.||
8104|100|P|   If you develop an eye infection or injury, or have eye||
8104|101|P|surgery, check with your doctor about whether you should continue||
8104|102|P|to use your current bottle of dorzolamide. You may be advised to||
8104|103|P|start using a new bottle.||
8104|104|P|   Before having surgery, tell your doctor or dentist about all||
8104|105|P|the products you use (including prescription drugs,||
8104|106|P|nonprescription drugs, and herbal products).||
8104|107|P|   After you apply this drug, your vision may become temporarily||
8104|108|P|blurred or unstable. Do not drive, use machinery, or do anything||
8104|109|P|that needs clear vision until you can do it safely.||
8104|110|P|   During pregnancy, this medication should be used only when||
8104|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
8104|112|P|   It is unknown if this drug passes into breast milk. Consult||
8104|113|P|your doctor before breastfeeding.||
8104|114|B|||
8104|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8104|116|I|medications work or increase your risk for serious side effects.||
8104|117|I|This document does not contain all possible drug interactions.||
8104|118|I|Keep a list of all the products you use (including||
8104|119|I|prescription/nonprescription drugs and herbal products) and share||
8104|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
8104|121|I|the dosage of any medicines without your doctor's approval.||
8104|122|B|||
8104|123|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8104|124|O|has overdosed and has serious symptoms such as passing out or||
8104|125|O|trouble breathing, call 911. Otherwise, call a poison control||
8104|126|O|center right away. US residents can call 1-800-222-1222. Canada||
8104|127|O|residents can call 1-844-764-7669.||
8104|128|B|||
8104|129|N|NOTES:  Do not share this medication with others.||
8104|130|N|   Lab and/or medical tests (such as eye exams) should be done||
8104|131|N|while you are using this medication. Keep all medical and lab||
8104|132|N|appointments. Consult your doctor for more details.||
8104|133|B|||
8104|134|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8104|135|D|If it is near the time of the next dose, skip the missed dose.||
8104|136|D|Use your next dose at the regular time. Do not double the dose to||
8104|137|D|catch up.||
8104|138|B|||
8104|139|R|STORAGE:  Store at room temperature away from light. This product||
8104|140|R|is normally colorless. Discard the solution if it changes color,||
8104|141|R|becomes cloudy, or develops particles. Keep all medications away||
8104|142|R|from children and pets.||
8104|143|R|   Do not flush medications down the toilet or pour them into a||
8104|144|R|drain unless instructed to do so. Properly discard this product||
8104|145|R|when it is expired or no longer needed. Consult your pharmacist||
8104|146|R|or local waste disposal company.||
8104|147|B|||
8104|148|A|Information last revised May 2025.||
8104|149|A|Copyright(c) 2025 First Databank, Inc.||
8104|150|B|||
8106|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8106|002|Z|does NOT have all possible information about this product. This||
8106|003|Z|information does not assure that this product is safe, effective,||
8106|004|Z|or appropriate for you. This information is not individual||
8106|005|Z|medical advice and does not substitute for the advice of your||
8106|006|Z|health care professional. Always ask your health care||
8106|007|Z|professional for complete information about this product and your||
8106|008|Z|specific health needs.||
8106|009|B|||
8106|010|T|VITAMIN K - ORAL||
8106|011|F|(VYE-ta-min)||
8106|012|B|||
8106|013|C|COMMON BRAND NAME(S): Mephyton||
8106|014|B|||
8106|015|U|USES:  Vitamin K is used to treat and prevent low levels of||
8106|016|U|certain substances (blood clotting factors) that your body||
8106|017|U|naturally produces. These substances help your blood to thicken||
8106|018|U|and stop bleeding normally (such as after an accidental cut or||
8106|019|U|injury). Low levels of blood clotting factors increase the risk||
8106|020|U|for unusual bleeding. Low levels may be caused by certain||
8106|021|U|medications (such as warfarin) or medical conditions (such as||
8106|022|U|obstructive jaundice). Vitamin K helps to treat and prevent||
8106|023|U|unusual bleeding by increasing the body's production of blood||
8106|024|U|clotting factors.||
8106|025|B|||
8106|026|V|OTHER USES:  This section contains uses of this drug that are not||
8106|027|V|listed in the approved professional labeling for the drug but||
8106|028|V|that may be prescribed by your health care professional. Use this||
8106|029|V|drug for a condition that is listed in this section only if it||
8106|030|V|has been so prescribed by your health care professional.||
8106|031|V|   This drug may also be used for low levels of vitamin K in||
8106|032|V|people who do not get enough of it from their diets.||
8106|033|B|||
8106|034|H|HOW TO USE:  If you are taking the over-the-counter product to||
8106|035|H|self-treat, read all directions on the product package before||
8106|036|H|taking this medication. If you have any questions, consult your||
8106|037|H|pharmacist. If your doctor has prescribed this medication, take||
8106|038|H|it as directed.||
8106|039|H|   If you are using the rapidly-dissolving tablets, place under||
8106|040|H|your tongue to dissolve, then swallow with or without water. Some||
8106|041|H|brands may also be swallowed whole.||
8106|042|H|   The dosage is based on your age, medical condition and||
8106|043|H|response to treatment. Do not increase your dose or use this drug||
8106|044|H|more often or for longer than directed. Your condition will not||
8106|045|H|improve any faster, and your risk of side effects will increase.||
8106|046|H|   If you are using a certain "blood thinner" drug (warfarin),||
8106|047|H|vitamin K can decrease the effects of warfarin for up to 2 weeks.||
8106|048|H|Be sure to take your vitamin K and warfarin exactly as directed||
8106|049|H|by your doctor or pharmacist.||
8106|050|H|   If you develop easy bruising or bleeding, or if you think you||
8106|051|H|may have a serious medical problem, get medical help right away.||
8106|052|H|You may need another dose of vitamin K.||
8106|053|B|||
8106|054|S|SIDE EFFECTS:  Vitamin K usually has no side effects. If you have||
8106|055|S|any unusual effects, contact your doctor or pharmacist promptly.||
8106|056|S|   If your doctor has directed you to use this product, remember||
8106|057|S|that your doctor has judged that the benefit to you is greater||
8106|058|S|than the risk of side effects. Many people using this product do||
8106|059|S|not have serious side effects.||
8106|060|S|   A very serious allergic reaction to this drug is rare.||
8106|061|S|However, get medical help right away if you notice any symptoms||
8106|062|S|of a serious allergic reaction, including: rash, itching/swelling||
8106|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8106|064|S|breathing.||
8106|065|S|   This is not a complete list of possible side effects. If you||
8106|066|S|notice other effects not listed above, contact your doctor or||
8106|067|S|pharmacist.||
8106|068|S|   In the US -||
8106|069|S|   Call your doctor for medical advice about side effects. You||
8106|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8106|071|S|www.fda.gov/medwatch.||
8106|072|S|   In Canada - Call your doctor for medical advice about side||
8106|073|S|effects. You may report side effects to Health Canada at||
8106|074|S|1-866-234-2345.||
8106|075|B|||
8106|076|P|PRECAUTIONS:  Before taking vitamin K, tell your doctor or||
8106|077|P|pharmacist if you are allergic to it; or if you have any other||
8106|078|P|allergies. This product may contain inactive ingredients, which||
8106|079|P|can cause allergic reactions or other problems. Talk to your||
8106|080|P|pharmacist for more details.||
8106|081|P|   Before using this medication, tell your doctor or pharmacist||
8106|082|P|your medical history, especially of: blood disorders, gallbladder||
8106|083|P|disease (such as obstructive jaundice, biliary fistula), liver||
8106|084|P|disease.||
8106|085|P|   Before having surgery, tell your doctor or dentist about all||
8106|086|P|the products you use (including prescription drugs,||
8106|087|P|nonprescription drugs, and herbal products).||
8106|088|P|   During pregnancy, this product should be used only when||
8106|089|P|clearly needed. Discuss the risks and benefits with your doctor.||
8106|090|P|   Vitamin K passes into breast milk, but is unlikely to harm a||
8106|091|P|nursing infant. Consult your doctor before breastfeeding.||
8106|092|B|||
8106|093|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8106|094|I|medications work or increase your risk for serious side effects.||
8106|095|I|This document does not contain all possible drug interactions.||
8106|096|I|Keep a list of all the products you use (including||
8106|097|I|prescription/nonprescription drugs and herbal products) and share||
8106|098|I|it with your doctor and pharmacist. Do not start, stop, or change||
8106|099|I|the dosage of any medicines without your doctor's approval.||
8106|100|I|   Some products that may interact with this drug include: "blood||
8106|101|I|thinners" (such as acenocoumarol, warfarin).||
8106|102|I|   Avoid taking this medication at the same time as orlistat (a||
8106|103|I|weight-management drug). Wait at least 2 hours between taking||
8106|104|I|this medication and orlistat because taking them together may||
8106|105|I|decrease the effect of vitamin K.||
8106|106|B|||
8106|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8106|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8106|109|O|poison control center right away. US residents can call||
8106|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8106|111|B|||
8106|112|N|NOTES:  Lab tests (such as prothrombin time, INR) may be done||
8106|113|N|while you are taking this product. Keep all medical and lab||
8106|114|N|appointments. Consult your doctor for more details.||
8106|115|N|   Remember that it is best to get your vitamins and minerals||
8106|116|N|from food whenever possible. Eat a well-balanced diet, and follow||
8106|117|N|any dietary guidelines as directed by your doctor. Foods rich in||
8106|118|N|vitamin K include green leafy vegetables such as spinach,||
8106|119|N|collards, and broccoli.||
8106|120|B|||
8106|121|D|MISSED DOSE:  If you are taking this product on a regular||
8106|122|D|schedule and miss a dose, take it as soon as you remember. If it||
8106|123|D|is near the time of the next dose, skip the missed dose. Take||
8106|124|D|your next dose at the regular time. Do not double the dose to||
8106|125|D|catch up.||
8106|126|B|||
8106|127|R|STORAGE:  Store at room temperature away from light and moisture.||
8106|128|R|Do not store in the bathroom. Keep all medications away from||
8106|129|R|children and pets.||
8106|130|R|   Do not flush medications down the toilet or pour them into a||
8106|131|R|drain unless instructed to do so. Properly discard this product||
8106|132|R|when it is expired or no longer needed. Consult your pharmacist||
8106|133|R|or local waste disposal company.||
8106|134|B|||
8106|135|A|Information last revised May 2024.||
8106|136|A|Copyright(c) 2025 First Databank, Inc.||
8106|137|B|||
8108|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8108|002|Z|does NOT have all possible information about this product. This||
8108|003|Z|information does not assure that this product is safe, effective,||
8108|004|Z|or appropriate for you. This information is not individual||
8108|005|Z|medical advice and does not substitute for the advice of your||
8108|006|Z|health care professional. Always ask your health care||
8108|007|Z|professional for complete information about this product and your||
8108|008|Z|specific health needs.||
8108|009|B|||
8108|010|T|CYCLOSPORINE - INTRAVENOUS||
8108|011|F|(SYE-kloe-SPOR-in)||
8108|012|B|||
8108|013|C|COMMON BRAND NAME(S): Sandimmune||
8108|014|B|||
8108|015|W|WARNING:  Cyclosporine lowers your ability to fight infections.||
8108|016|W|This may make you more likely to get a serious (rarely fatal)||
8108|017|W|infection or make any infection you have worse. This effect may||
8108|018|W|also increase your risk of getting certain types of cancer (such||
8108|019|W|as skin cancer, lymphoma). Tell your doctor right away if you||
8108|020|W|have any signs of infection or cancer, such as sore throat that||
8108|021|W|doesn't go away, fever, chills, burning/frequent urination,||
8108|022|W|unusual skin changes, change in appearance or size of moles,||
8108|023|W|unusual weight loss, swollen lymph nodes, unusual lumps, night||
8108|024|W|sweats.||
8108|025|W|   Cyclosporine can also cause high blood pressure and kidney||
8108|026|W|problems. The risk of both problems increases with higher doses||
8108|027|W|and longer treatment with this drug. Your doctor will monitor||
8108|028|W|your blood pressure and kidney function while you use this||
8108|029|W|medication.||
8108|030|W|   Psoriasis patients who have had certain previous treatments||
8108|031|W|(such as coal tar, methotrexate, radiation treatment, light||
8108|032|W|treatment with PUVA/UVB) are at increased risk to develop skin||
8108|033|W|cancer. Talk to your doctor of the risks and benefits of this||
8108|034|W|medication.||
8108|035|B|||
8108|036|U|USES:  Cyclosporine is used to prevent organ rejection in people||
8108|037|U|who have received a liver, kidney, or heart transplant. It is||
8108|038|U|usually used along with other medications to allow your new organ||
8108|039|U|to function normally. Cyclosporine belongs to a class of drugs||
8108|040|U|known as immunosuppressants. It works by weakening the immune||
8108|041|U|system to help your body accept the new organ as if it were your||
8108|042|U|own.||
8108|043|U|   Because of the risk of severe allergic reactions from||
8108|044|U|intravenous cyclosporine, it should only be used by patients who||
8108|045|U|are unable to take cyclosporine by mouth. Once you are able to||
8108|046|U|take medications by mouth, you should be switched from this form||
8108|047|U|of cyclosporine to either the capsules or oral solution.||
8108|048|B|||
8108|049|V|OTHER USES:  This section contains uses of this drug that are not||
8108|050|V|listed in the approved professional labeling for the drug but||
8108|051|V|that may be prescribed by your health care professional. Use this||
8108|052|V|drug for a condition that is listed in this section only if it||
8108|053|V|has been so prescribed by your health care professional.||
8108|054|V|   This drug may also be used to reduce the risk of rejection in||
8108|055|V|other types of organ transplants (such as cornea, pancreas) or||
8108|056|V|bone marrow transplant. It may also be used for other conditions||
8108|057|V|that are affected by the body's immune system (such as Crohn's||
8108|058|V|disease, rheumatoid arthritis, plaque psoriasis).||
8108|059|B|||
8108|060|H|HOW TO USE:  This medication is given by injection into a vein as||
8108|061|H|directed by your doctor, usually once daily over 2 to 6 hours.||
8108|062|H|The dosage is based on your weight, medical condition, lab tests,||
8108|063|H|and response to treatment.||
8108|064|H|   If you are using this medication at home, learn all||
8108|065|H|preparation and usage instructions from your health care||
8108|066|H|professional. Before using, check this product for particles or||
8108|067|H|discoloration. If either is present, do not use the liquid. Learn||
8108|068|H|how to store and discard medical supplies safely.||
8108|069|H|   When cyclosporine is given into a vein, one of the other||
8108|070|H|ingredients in this product (polyoxyethylated castor oil) may||
8108|071|H|rarely cause a serious allergic reaction. If you are using this||
8108|072|H|medication at home, be prepared to self-treat as directed by your||
8108|073|H|doctor if symptoms of an allergic reaction occur. (See also Side||
8108|074|H|Effects section.)||
8108|075|H|   Use this medication regularly to get the most benefit from it.||
8108|076|H|To help you remember, use it at the same time each day.||
8108|077|B|||
8108|078|S|SIDE EFFECTS:  See also Warning section.||
8108|079|S|   Shaking, headache, dizziness, unusual growth of body hair,||
8108|080|S|nausea/vomiting, diarrhea, or stomach upset may occur. If any of||
8108|081|S|these effects last or get worse, tell your doctor or pharmacist||
8108|082|S|promptly.||
8108|083|S|   Unusual growth and swelling of the gums may occur. Brush your||
8108|084|S|teeth and floss daily to reduce this problem. See your dentist||
8108|085|S|regularly.||
8108|086|S|   Remember that this medication has been prescribed because your||
8108|087|S|doctor has judged that the benefit to you is greater than the||
8108|088|S|risk of side effects. Many people using this medication do not||
8108|089|S|have serious side effects.||
8108|090|S|   This medication may raise your blood pressure. Check your||
8108|091|S|blood pressure regularly and tell your doctor if the results are||
8108|092|S|high. Your doctor may control your blood pressure with||
8108|093|S|medication.||
8108|094|S|   Tell your doctor right away if you have any serious side||
8108|095|S|effects, including: signs of kidney problems (such as a change in||
8108|096|S|the amount of urine), signs of liver disease (such as||
8108|097|S|nausea/vomiting that doesn't stop, dark urine, yellowing||
8108|098|S|eyes/skin, stomach/abdominal pain), easy bruising/bleeding,||
8108|099|S|unusual tiredness, muscle weakness/spasms, slow/irregular||
8108|100|S|heartbeat, numb/tingling skin, severe leg pain.||
8108|101|S|   Get medical help right away if you have any very serious side||
8108|102|S|effects, including: mental/mood changes (such as confusion,||
8108|103|S|difficulty concentrating), vision changes, problems with speech,||
8108|104|S|clumsiness, loss of coordination, weakness on one side of the||
8108|105|S|body, chest pain, seizures.||
8108|106|S|   A very serious allergic reaction to this drug is rare.||
8108|107|S|However, get medical help right away if you notice any symptoms||
8108|108|S|of a serious allergic reaction, including: rash, itching/swelling||
8108|109|S|(especially of the face/tongue/throat), flushing, severe||
8108|110|S|dizziness, trouble breathing.||
8108|111|S|   This is not a complete list of possible side effects. If you||
8108|112|S|notice other effects not listed above, contact your doctor or||
8108|113|S|pharmacist.||
8108|114|S|   In the US -||
8108|115|S|   Call your doctor for medical advice about side effects. You||
8108|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8108|117|S|www.fda.gov/medwatch.||
8108|118|S|   In Canada - Call your doctor for medical advice about side||
8108|119|S|effects. You may report side effects to Health Canada at||
8108|120|S|1-866-234-2345.||
8108|121|B|||
8108|122|P|PRECAUTIONS:  Before using cyclosporine, tell your doctor or||
8108|123|P|pharmacist if you are allergic to it; or if you have any other||
8108|124|P|allergies. This product may contain inactive ingredients (such as||
8108|125|P|polyoxyethylated castor oil), which can cause allergic reactions||
8108|126|P|or other problems. Talk to your pharmacist for more details.||
8108|127|P|   Before using this medication, tell your doctor or pharmacist||
8108|128|P|your medical history, especially of: kidney disease, liver||
8108|129|P|disease, high blood pressure, cancer, skin lesions of unknown||
8108|130|P|cause, radiation treatment (including light treatment with PUVA||
8108|131|P|or UVB), mineral imbalance (such as low level of magnesium or||
8108|132|P|high level of potassium), recent/current infections, high||
8108|133|P|cholesterol/triglycerides levels.||
8108|134|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8108|135|P|can make you more dizzy. Do not drive, use machinery, or do||
8108|136|P|anything that needs alertness until you can do it safely. Limit||
8108|137|P|alcoholic beverages. Talk to your doctor if you are using||
8108|138|P|marijuana (cannabis).||
8108|139|P|   This medication may contain alcohol. Caution is advised if you||
8108|140|P|are pregnant or breastfeeding or have liver disease, alcohol||
8108|141|P|dependence, or any other condition that requires you to||
8108|142|P|limit/avoid alcohol in your diet. Ask your doctor or pharmacist||
8108|143|P|about using this product safely.||
8108|144|P|   Cyclosporine can make you more likely to get infections or may||
8108|145|P|make current infections worse. Stay away from anyone who has an||
8108|146|P|infection that may easily spread (such as chickenpox, COVID-19,||
8108|147|P|measles, flu). Talk to your doctor if you have been exposed to an||
8108|148|P|infection or for more details.||
8108|149|P|   Tell your health care professional that you are using||
8108|150|P|cyclosporine before having any immunizations/vaccinations. Avoid||
8108|151|P|contact with people who have recently received live vaccines||
8108|152|P|(such as flu vaccine inhaled through the nose).||
8108|153|P|   This medication may increase your risk of developing skin||
8108|154|P|cancer. Limit your time in the sun. Avoid tanning booths and||
8108|155|P|sunlamps. Use sunscreen and wear protective clothing when||
8108|156|P|outdoors. Your doctor may direct you to avoid phototherapy while||
8108|157|P|you use this product. Ask your doctor for details.||
8108|158|P|   This product may increase your potassium levels. Before using||
8108|159|P|potassium supplements or salt substitutes that contain potassium,||
8108|160|P|consult your doctor or pharmacist.||
8108|161|P|   Before having surgery, tell your doctor or dentist about all||
8108|162|P|the products you use (including prescription drugs,||
8108|163|P|nonprescription drugs, and herbal products).||
8108|164|P|   Older adults may be at greater risk for kidney problems or||
8108|165|P|high blood pressure while using this drug.||
8108|166|P|   During pregnancy, this medication should be used only when||
8108|167|P|clearly needed. It may harm an unborn baby or cause other||
8108|168|P|problems with the baby such as being born too early (premature)||
8108|169|P|or having low birth weight. Discuss the risks and benefits with||
8108|170|P|your doctor.||
8108|171|P|   This medication passes into breast milk. Consult your doctor||
8108|172|P|before breastfeeding.||
8108|173|B|||
8108|174|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8108|175|I|medications work or increase your risk for serious side effects.||
8108|176|I|This document does not contain all possible drug interactions.||
8108|177|I|Keep a list of all the products you use (including||
8108|178|I|prescription/nonprescription drugs and herbal products) and share||
8108|179|I|it with your doctor and pharmacist. Do not start, stop, or change||
8108|180|I|the dosage of any medicines without your doctor's approval.||
8108|181|I|   Some products that may interact with this drug include: coal||
8108|182|I|tar, orlistat, other drugs that weaken the immune system/increase||
8108|183|I|the risk of infection (such as natalizumab, rituximab,||
8108|184|I|tofacitinib), drugs that may increase potassium levels (such as||
8108|185|I|potassium supplements, certain diuretics/"water pills" including||
8108|186|I|amiloride, spironolactone), tacrolimus.||
8108|187|I|   Other medications can affect the removal of cyclosporine from||
8108|188|I|your body, which may affect how cyclosporine works. Examples||
8108|189|I|include bosentan, mifepristone, St. John's wort, ritonavir, among||
8108|190|I|others.||
8108|191|I|   This medication can slow down the removal of other medications||
8108|192|I|from your body, which may affect how they work. Examples of||
8108|193|I|affected drugs include aliskiren, dabigatran, dronedarone,||
8108|194|I|elagolix, resmetirom, certain statins (such as pitavastatin,||
8108|195|I|simvastatin), voxilaprevir, among others.||
8108|196|B|||
8108|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8108|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8108|199|O|poison control center right away. US residents can call||
8108|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8108|201|B|||
8108|202|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
8108|203|N|blood pressure, blood mineral levels, cyclosporine blood levels,||
8108|204|N|complete blood count, uric acid levels, lipid levels, skin exam)||
8108|205|N|should be done while you are using this medication. Keep all||
8108|206|N|medical and lab appointments. Consult your doctor for more||
8108|207|N|details.||
8108|208|N|   If you have had an organ transplant, attend a transplant||
8108|209|N|education class or support group. Learn the symptoms of organ||
8108|210|N|rejection such as a feeling of being ill, fever, and pain around||
8108|211|N|the transplanted organ. Also learn the signs of a failing||
8108|212|N|transplanted organ, such as a decrease in the amount of urine||
8108|213|N|with kidney transplant, yellowing of the skin/eyes with liver||
8108|214|N|transplant, shortness of breath/inability to exercise with heart||
8108|215|N|transplant. Get medical help right away if these symptoms of||
8108|216|N|rejection occur.||
8108|217|B|||
8108|218|D|MISSED DOSE:  It is important to get each dose of this medication||
8108|219|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8108|220|D|right away for a new dosing schedule. Do not double the dose to||
8108|221|D|catch up.||
8108|222|B|||
8108|223|R|STORAGE:  Consult the product instructions and your pharmacist||
8108|224|R|for storage details. Keep all medications away from children and||
8108|225|R|pets.||
8108|226|R|   Do not flush medications down the toilet or pour them into a||
8108|227|R|drain unless instructed to do so. Properly discard this product||
8108|228|R|when it is expired or no longer needed. Consult your pharmacist||
8108|229|R|or local waste disposal company.||
8108|230|B|||
8108|231|M|MEDICAL ALERT:  Your condition can cause complications in a||
8108|232|M|medical emergency. For information about enrolling in MedicAlert,||
8108|233|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8108|234|B|||
8108|235|A|Information last revised May 2025.||
8108|236|A|Copyright(c) 2025 First Databank, Inc.||
8108|237|B|||
8109|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8109|002|Z|does NOT have all possible information about this product. This||
8109|003|Z|information does not assure that this product is safe, effective,||
8109|004|Z|or appropriate for you. This information is not individual||
8109|005|Z|medical advice and does not substitute for the advice of your||
8109|006|Z|health care professional. Always ask your health care||
8109|007|Z|professional for complete information about this product and your||
8109|008|Z|specific health needs.||
8109|009|B|||
8109|010|T|LACTULOSE (LAXATIVE) - ORAL||
8109|011|F|(LACK-tew-lohss)||
8109|012|B|||
8109|013|C|COMMON BRAND NAME(S): Cephulac, Chronulac, Constulose||
8109|014|B|||
8109|015|U|USES:  This medication is a laxative used to treat constipation.||
8109|016|U|It may help to increase the number of bowel movements per day and||
8109|017|U|the number of days you have a bowel movement. Lactulose is a||
8109|018|U|colonic acidifier that works by increasing stool water content||
8109|019|U|and softening the stool. It is a man-made sugar solution.||
8109|020|B|||
8109|021|V|OTHER USES:  This section contains uses of this drug that are not||
8109|022|V|listed in the approved professional labeling for the drug, but||
8109|023|V|may be prescribed by your health care professional. Use this drug||
8109|024|V|for a condition that is listed in this section only if has been||
8109|025|V|so prescribed by your health care professional.||
8109|026|V|   This drug is also used for complications of liver disease||
8109|027|V|(hepatic encephalopathy).||
8109|028|B|||
8109|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
8109|030|H|doctor, usually once daily for constipation. If you are taking||
8109|031|H|the solution, to improve the taste, you may mix it into fruit||
8109|032|H|juice, water, milk, or a soft dessert. If you are using the||
8109|033|H|crystals in packets, dissolve the contents of the packet in half||
8109|034|H|a glass of water (4 ounces or 120 milliliters), or as directed by||
8109|035|H|your doctor.||
8109|036|H|   Use this medication regularly in order to get the most benefit||
8109|037|H|from it. Remember to take it at the same time each day. The||
8109|038|H|dosage is based on your medical condition and response to||
8109|039|H|treatment.||
8109|040|H|   It may take up to 48 hours to have a bowel movement. Tell your||
8109|041|H|doctor if your condition lasts or gets worse.||
8109|042|B|||
8109|043|S|SIDE EFFECTS:  Gas, bloating, burping, stomach rumbling/pain,||
8109|044|S|nausea, and cramps may occur. If any of these effects last or get||
8109|045|S|worse, tell your doctor or pharmacist promptly.||
8109|046|S|   Remember that this medication has been prescribed because your||
8109|047|S|doctor has judged that the benefit to you is greater than the||
8109|048|S|risk of side effects. Many people using this medication do not||
8109|049|S|have serious side effects.||
8109|050|S|   Tell your doctor right away if you have any serious side||
8109|051|S|effects, including: stomach/abdominal pain that is severe or||
8109|052|S|doesn't go away, diarrhea, vomiting, muscle cramps/weakness,||
8109|053|S|irregular heartbeat, mental/mood changes, seizures, bloody||
8109|054|S|stools, rectal bleeding.||
8109|055|S|   A very serious allergic reaction to this drug is rare.||
8109|056|S|However, get medical help right away if you notice any symptoms||
8109|057|S|of a serious allergic reaction, including: rash, itching/swelling||
8109|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8109|059|S|breathing.||
8109|060|S|   This is not a complete list of possible side effects. If you||
8109|061|S|notice other effects not listed above, contact your doctor or||
8109|062|S|pharmacist.||
8109|063|S|   In the US -||
8109|064|S|   Call your doctor for medical advice about side effects. You||
8109|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8109|066|S|www.fda.gov/medwatch.||
8109|067|S|   In Canada - Call your doctor for medical advice about side||
8109|068|S|effects. You may report side effects to Health Canada at||
8109|069|S|1-866-234-2345.||
8109|070|B|||
8109|071|P|PRECAUTIONS:  Before taking lactulose, tell your doctor or||
8109|072|P|pharmacist if you are allergic to it; or if you have any other||
8109|073|P|allergies. This product may contain inactive ingredients, which||
8109|074|P|can cause allergic reactions or other problems. Talk to your||
8109|075|P|pharmacist for more details.||
8109|076|P|   Before using this medication, tell your doctor or pharmacist||
8109|077|P|your medical history, especially of: a low galactose diet (such||
8109|078|P|as a diet that includes few or no milk products), certain other||
8109|079|P|bowel problem (bowel obstruction), diabetes.||
8109|080|P|   Before having surgery, tell your doctor or dentist about all||
8109|081|P|the products you use (including prescription drugs,||
8109|082|P|nonprescription drugs, and herbal products).||
8109|083|P|   This medication contains different sugars. If you have||
8109|084|P|diabetes, this medication may affect your blood sugar. Check your||
8109|085|P|blood sugar regularly as directed and share the results with your||
8109|086|P|doctor. Your doctor may need to adjust your diabetes medication,||
8109|087|P|exercise program, or diet.||
8109|088|P|   Older adults may be at a greater risk for loss of blood||
8109|089|P|minerals (such as potassium, sodium) while using this drug,||
8109|090|P|especially if they are using it for an extended time.||
8109|091|P|   During pregnancy, this medication should be used only when||
8109|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
8109|093|P|   It is unknown if this drug passes into breast milk. Consult||
8109|094|P|your doctor before breastfeeding.||
8109|095|B|||
8109|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8109|097|I|medications work or increase your risk for serious side effects.||
8109|098|I|This document does not contain all possible drug interactions.||
8109|099|I|Keep a list of all the products you use (including||
8109|100|I|prescription/nonprescription drugs and herbal products) and share||
8109|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
8109|102|I|the dosage of any medicines without your doctor's approval.||
8109|103|I|   Some products that may interact with this drug are: antacids||
8109|104|I|containing aluminum and/or magnesium, other laxatives.||
8109|105|B|||
8109|106|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8109|107|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8109|108|O|poison control center right away. US residents can call||
8109|109|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8109|110|O|Symptoms of overdose may include: severe stomach cramps,||
8109|111|O|diarrhea.||
8109|112|B|||
8109|113|N|NOTES:  Do not share this product with others.||
8109|114|N|   If you use this product for a long time, lab and/or medical||
8109|115|N|tests (such as blood mineral levels) should be done while you are||
8109|116|N|taking this medication. Keep all medical and lab appointments.||
8109|117|N|Consult your doctor for more details.||
8109|118|B|||
8109|119|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8109|120|D|remember. If it is near the time of the next dose, skip the||
8109|121|D|missed dose. Take your next dose at the regular time. Do not||
8109|122|D|double the dose to catch up.||
8109|123|B|||
8109|124|R|STORAGE:  Store at room temperature away from light. Do not||
8109|125|R|freeze. Keep all medications away from children and pets.||
8109|126|R|   Do not flush medications down the toilet or pour them into a||
8109|127|R|drain unless instructed to do so. Properly discard this product||
8109|128|R|when it is expired or no longer needed. Consult your pharmacist||
8109|129|R|or local waste disposal company.||
8109|130|B|||
8109|131|A|Information last revised September 2024.||
8109|132|A|Copyright(c) 2025 First Databank, Inc.||
8109|133|B|||
8110|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8110|002|Z|does NOT have all possible information about this product. This||
8110|003|Z|information does not assure that this product is safe, effective,||
8110|004|Z|or appropriate for you. This information is not individual||
8110|005|Z|medical advice and does not substitute for the advice of your||
8110|006|Z|health care professional. Always ask your health care||
8110|007|Z|professional for complete information about this product and your||
8110|008|Z|specific health needs.||
8110|009|B|||
8110|010|T|ZOLPIDEM - ORAL||
8110|011|F|(ZOHL-pee-dem)||
8110|012|B|||
8110|013|C|COMMON BRAND NAME(S): Ambien||
8110|014|B|||
8110|015|W|WARNING:  Rarely, after taking this drug, people have gotten out||
8110|016|W|of bed and driven vehicles while not fully awake||
8110|017|W|("sleep-driving"). People have also sleepwalked, prepared/eaten||
8110|018|W|food, made phone calls, or had sex while not fully awake. Often,||
8110|019|W|these people do not remember these events. This problem can be||
8110|020|W|dangerous (possibly fatal) to you or to others. If you find out||
8110|021|W|that you have done any of these activities after taking this||
8110|022|W|medication, tell your doctor right away. You should not take this||
8110|023|W|medication or similar medications (such as eszopiclone, zaleplon)||
8110|024|W|if you have this reaction to the medication.||
8110|025|B|||
8110|026|U|USES:  Zolpidem is used for a short time to treat a certain sleep||
8110|027|U|problem (insomnia) in adults. If you have trouble falling asleep,||
8110|028|U|it helps you fall asleep faster, so you can get a better night's||
8110|029|U|rest. Zolpidem belongs to a class of drugs called||
8110|030|U|sedative-hypnotics. It acts on your brain to produce a calming||
8110|031|U|effect.||
8110|032|B|||
8110|033|H|HOW TO USE:  Read the Medication Guide and, if available, the||
8110|034|H|Patient Information Leaflet provided by your pharmacist before||
8110|035|H|you start taking zolpidem and each time you get a refill. If you||
8110|036|H|have any questions, ask your doctor or pharmacist.||
8110|037|H|   Take this medication by mouth on an empty stomach as directed||
8110|038|H|by your doctor, usually once a night. Since zolpidem works||
8110|039|H|quickly, take it right before you get into bed. Do not take it||
8110|040|H|with or after a meal because it will not work as quickly. If you||
8110|041|H|are taking the capsule form of this medication, swallow whole. Do||
8110|042|H|not open, chew, or crush the capsules.||
8110|043|H|   Do not take a dose of this drug unless you have time for a||
8110|044|H|full night's sleep of at least 7 to 8 hours. If you have to wake||
8110|045|H|up before that, you may have some memory loss and may have||
8110|046|H|trouble safely doing anything that needs alertness, such as||
8110|047|H|driving or operating machinery. (See also Precautions section.)||
8110|048|H|   Dosage is based on your gender, age, medical condition, other||
8110|049|H|medications you may be taking, and response to treatment. Do not||
8110|050|H|increase your dose, take it more often, or use it for longer than||
8110|051|H|prescribed. Do not take more than 10 milligrams a day. Women are||
8110|052|H|usually prescribed a lower dose because the drug is removed from||
8110|053|H|the body more slowly than in men. Older adults are usually||
8110|054|H|prescribed a lower dose to decrease the risk of side effects.||
8110|055|H|   If you suddenly stop using this medication, you may have||
8110|056|H|withdrawal symptoms (such as nausea, vomiting, flushing, stomach||
8110|057|H|cramps, nervousness, shakiness). To help prevent withdrawal, your||
8110|058|H|doctor may lower your dose slowly. Withdrawal is more likely if||
8110|059|H|you have used zolpidem for a long time or in high doses. Tell||
8110|060|H|your doctor or pharmacist right away if you have withdrawal.||
8110|061|H|   Though it helps many people, this medication may sometimes||
8110|062|H|cause addiction. This risk may be higher if you have a substance||
8110|063|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
8110|064|H|Take this medication exactly as prescribed to lower the risk of||
8110|065|H|addiction. Ask your doctor or pharmacist for more details.||
8110|066|H|   When this medication is used for a long time, it may not work||
8110|067|H|as well. Talk with your doctor if this medication stops working||
8110|068|H|well.||
8110|069|H|   Tell your doctor if your condition lasts after 7 to 10 days,||
8110|070|H|or if it gets worse.||
8110|071|H|   You may have trouble sleeping the first few nights after you||
8110|072|H|stop taking this medication. This is called rebound insomnia and||
8110|073|H|is normal. It will usually go away after 1-2 nights. If this||
8110|074|H|effect continues, contact your doctor.||
8110|075|B|||
8110|076|S|SIDE EFFECTS:  See also Warning section.||
8110|077|S|   Dizziness may occur. If this effect lasts or gets worse, tell||
8110|078|S|your doctor or pharmacist promptly.||
8110|079|S|   This medication may make you sleepy during the day. Tell your||
8110|080|S|doctor if you have daytime drowsiness. Your dose may need to be||
8110|081|S|adjusted.||
8110|082|S|   Remember that this medication has been prescribed because your||
8110|083|S|doctor has judged that the benefit to you is greater than the||
8110|084|S|risk of side effects. Many people using this medication do not||
8110|085|S|have serious side effects.||
8110|086|S|   Tell your doctor right away if you have any serious side||
8110|087|S|effects, including: memory loss, mental/mood/behavior changes||
8110|088|S|(such as new/worsening depression, abnormal thoughts, thoughts of||
8110|089|S|suicide, hallucinations, confusion, agitation, aggressive||
8110|090|S|behavior, anxiety).||
8110|091|S|   A very serious allergic reaction to this drug is rare.||
8110|092|S|However, get medical help right away if you notice any symptoms||
8110|093|S|of a serious allergic reaction, including: rash, itching/swelling||
8110|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8110|095|S|breathing.||
8110|096|S|   This is not a complete list of possible side effects. If you||
8110|097|S|notice other effects not listed above, contact your doctor or||
8110|098|S|pharmacist.||
8110|099|S|   In the US -||
8110|100|S|   Call your doctor for medical advice about side effects. You||
8110|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8110|102|S|www.fda.gov/medwatch.||
8110|103|S|   In Canada - Call your doctor for medical advice about side||
8110|104|S|effects. You may report side effects to Health Canada at||
8110|105|S|1-866-234-2345.||
8110|106|B|||
8110|107|P|PRECAUTIONS:  See also Warning section.||
8110|108|P|   Before taking zolpidem, tell your doctor or pharmacist if you||
8110|109|P|are allergic to it; or if you have any other allergies. This||
8110|110|P|product may contain inactive ingredients, which can cause||
8110|111|P|allergic reactions or other problems. Talk to your pharmacist for||
8110|112|P|more details.||
8110|113|P|   Before using this medication, tell your doctor or pharmacist||
8110|114|P|your medical history, especially of: kidney disease, liver||
8110|115|P|disease, mental/mood problems (such as depression, thoughts of||
8110|116|P|suicide), personal or family history of a substance use disorder||
8110|117|P|(such as overuse of or addiction to drugs/alcohol), personal or||
8110|118|P|family history of sleepwalking, lung/breathing problems (such as||
8110|119|P|chronic obstructive pulmonary disease-COPD, sleep apnea), a||
8110|120|P|certain muscle disease (myasthenia gravis).||
8110|121|P|   The effects of this drug can last even after you wake up the||
8110|122|P|next day. If you did not get 7 to 8 hours of sleep or took other||
8110|123|P|medications that made you sleepy or are more sensitive to this||
8110|124|P|drug, you may feel alert but not think clearly enough to drive.||
8110|125|P|You may also experience dizziness or blurred/double vision.||
8110|126|P|Alcohol or marijuana (cannabis) can make you more dizzy. Wait at||
8110|127|P|least 8 hours after taking this drug before driving, and do not||
8110|128|P|drive, use machinery, or do anything that needs alertness until||
8110|129|P|you can do it safely. This medication may also increase the risk||
8110|130|P|of falls. Avoid alcoholic beverages. Talk to your doctor if you||
8110|131|P|are using marijuana (cannabis).||
8110|132|P|   Before having surgery, tell your doctor or dentist about all||
8110|133|P|the products you use (including prescription drugs,||
8110|134|P|nonprescription drugs, and herbal products).||
8110|135|P|   Children may be more sensitive to the side effects of this||
8110|136|P|drug, especially dizziness and hallucinations.||
8110|137|P|   Older adults may be more sensitive to the side effects of this||
8110|138|P|drug, especially dizziness, confusion, unsteadiness, and||
8110|139|P|excessive drowsiness. These side effects can increase the risk of||
8110|140|P|falling.||
8110|141|P|   During pregnancy, this medication should be used only when||
8110|142|P|clearly needed. Babies born to mothers who have used this drug||
8110|143|P|late in the last 3 months of pregnancy may develop unusual||
8110|144|P|sleepiness, trouble breathing, unusual limpness, or withdrawal||
8110|145|P|symptoms. Get medical help right away if you notice any unusual||
8110|146|P|symptoms in your newborn. Discuss the risks and benefits with||
8110|147|P|your doctor.||
8110|148|P|   A small amount of this medication passes into breast milk and||
8110|149|P|may have undesirable effects on a nursing infant (such as unusual||
8110|150|P|sleepiness, trouble breathing, or unusual limpness). Get medical||
8110|151|P|help right away if you notice any unusual symptoms in your baby.||
8110|152|P|Ask your doctor if you should pump and discard your breast milk||
8110|153|P|during treatment and for 23 hours after a dose of this medication||
8110|154|P|to lessen the risk of these effects in your baby. Consult your||
8110|155|P|doctor before breastfeeding.||
8110|156|B|||
8110|157|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8110|158|I|medications work or increase your risk for serious side effects.||
8110|159|I|This document does not contain all possible drug interactions.||
8110|160|I|Keep a list of all the products you use (including||
8110|161|I|prescription/nonprescription drugs and herbal products) and share||
8110|162|I|it with your doctor and pharmacist. Do not start, stop, or change||
8110|163|I|the dosage of any medicines without your doctor's approval.||
8110|164|I|   A product that may interact with this drug is: sodium oxybate.||
8110|165|I|   Other medications can affect the removal of zolpidem from your||
8110|166|I|body, which may affect how zolpidem works. Examples include azole||
8110|167|I|antifungals (such as ketoconazole), rifampin, St. John's Wort,||
8110|168|I|among others.||
8110|169|I|   The risk of serious side effects (such as slow/shallow||
8110|170|I|breathing, severe drowsiness/dizziness) may be increased if this||
8110|171|I|medication is taken with other products that may also cause||
8110|172|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
8110|173|I|if you are taking other products such as opioid pain or cough||
8110|174|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8110|175|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
8110|176|I|lorazepam, zopiclone), muscle relaxants (such as carisoprodol,||
8110|177|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8110|178|I|diphenhydramine).||
8110|179|I|   Check the labels on all your medicines (such as allergy or||
8110|180|I|cough-and-cold products) because they may contain ingredients||
8110|181|I|that cause drowsiness. Ask your pharmacist about using those||
8110|182|I|products safely.||
8110|183|B|||
8110|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8110|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8110|186|O|poison control center right away. US residents can call||
8110|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8110|188|O|Symptoms of overdose may include slowed breathing or a deep sleep||
8110|189|O|from which you cannot be awakened.||
8110|190|B|||
8110|191|N|NOTES:  Do not share this medication with others. Sharing it is||
8110|192|N|against the law.||
8110|193|N|   As you get older, your sleep pattern may naturally change and||
8110|194|N|your sleep may be interrupted several times during the night.||
8110|195|N|Consult your doctor or pharmacist for ways to improve your sleep||
8110|196|N|without medication, such as avoiding caffeine and alcohol close||
8110|197|N|to bedtime, avoiding daytime naps, and going to bed at the same||
8110|198|N|time each night.||
8110|199|B|||
8110|200|D|MISSED DOSE:  If you miss a dose, do not take it unless you have||
8110|201|D|time to sleep for 7 to 8 hours afterwards.||
8110|202|B|||
8110|203|R|STORAGE:  Store at room temperature away from light and moisture.||
8110|204|R|Do not store in the bathroom. Keep all medications away from||
8110|205|R|children and pets.||
8110|206|R|   Do not flush medications down the toilet or pour them into a||
8110|207|R|drain unless instructed to do so. Properly discard this product||
8110|208|R|when it is expired or no longer needed. Consult your pharmacist||
8110|209|R|or local waste disposal company.||
8110|210|B|||
8110|211|A|Information last revised May 2024.||
8110|212|A|Copyright(c) 2025 First Databank, Inc.||
8110|213|B|||
8111|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8111|002|Z|does NOT have all possible information about this product. This||
8111|003|Z|information does not assure that this product is safe, effective,||
8111|004|Z|or appropriate for you. This information is not individual||
8111|005|Z|medical advice and does not substitute for the advice of your||
8111|006|Z|health care professional. Always ask your health care||
8111|007|Z|professional for complete information about this product and your||
8111|008|Z|specific health needs.||
8111|009|B|||
8111|010|T|COLESTIPOL TABLET - ORAL||
8111|011|F|(koe-LES-ti-pol)||
8111|012|B|||
8111|013|C|COMMON BRAND NAME(S): Colestid||
8111|014|B|||
8111|015|U|USES:  Colestipol is used along with a proper diet to lower||
8111|016|U|cholesterol in the blood. Lowering cholesterol helps decrease the||
8111|017|U|risk for strokes and heart attacks.||
8111|018|U|   In addition to a proper diet (such as a||
8111|019|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
8111|020|U|help this medication work better include exercising, losing||
8111|021|U|weight if overweight, and stopping smoking. Consult your doctor||
8111|022|U|for more details.||
8111|023|U|   This medication is known as a bile acid-binding resin. It||
8111|024|U|works by removing bile acid from the body. In people with high||
8111|025|U|cholesterol, this causes the liver to make more bile acid by||
8111|026|U|using cholesterol in the blood. This helps to lower the||
8111|027|U|cholesterol levels.||
8111|028|B|||
8111|029|H|HOW TO USE:  Take this medication by mouth as directed by your||
8111|030|H|doctor, usually 1 to 2 times a day. If your dose is more than 1||
8111|031|H|tablet, take the tablets one at a time. Do not try to swallow||
8111|032|H|more than one tablet at once. Take each tablet with plenty of||
8111|033|H|liquid (such as water, juice). Swallow each tablet whole. Do not||
8111|034|H|crush, chew, or break the tablets. If you have difficulty||
8111|035|H|swallowing the tablet whole, consult your doctor.||
8111|036|H|   The dosage is based on your medical condition and response to||
8111|037|H|treatment. To reduce your risk of side effects, your doctor may||
8111|038|H|direct you to start this medication at a low dose and gradually||
8111|039|H|increase your dose. Follow your doctor's instructions carefully.||
8111|040|H|It may take several weeks before you get the full benefit of this||
8111|041|H|drug.||
8111|042|H|   Colestipol may decrease your absorption of other medications.||
8111|043|H|Take your other medications as directed by your doctor, usually||
8111|044|H|at least 1 hour before or 4 to 6 hours after colestipol. Ask your||
8111|045|H|doctor or pharmacist for more information or if you have any||
8111|046|H|questions.||
8111|047|H|   Take this medication regularly in order to get the most||
8111|048|H|benefit from it. To help you remember, take it at the same||
8111|049|H|time(s) each day. Keep taking this medication even if you feel||
8111|050|H|well. Most people with high cholesterol do not feel sick.||
8111|051|B|||
8111|052|S|SIDE EFFECTS:  Constipation, stomach/abdominal pain, gas, nausea,||
8111|053|S|and vomiting may occur. If any of these effects last or get||
8111|054|S|worse, tell your doctor or pharmacist promptly.||
8111|055|S|   To prevent constipation, eat dietary fiber, drink enough||
8111|056|S|water, and exercise. You may also need to take a laxative. Ask||
8111|057|S|your pharmacist which type of laxative is right for you.||
8111|058|S|   Remember that this medication has been prescribed because your||
8111|059|S|doctor has judged that the benefit to you is greater than the||
8111|060|S|risk of side effects. Many people using this medication do not||
8111|061|S|have serious side effects.||
8111|062|S|   Tell your doctor right away if you have any serious side||
8111|063|S|effects, including: difficulty swallowing, chest pain/pressure,||
8111|064|S|severe stomach/abdominal pain, unusual bleeding/bruising, rapid||
8111|065|S|breathing, confusion.||
8111|066|S|   A very serious allergic reaction to this drug is rare.||
8111|067|S|However, get medical help right away if you notice any symptoms||
8111|068|S|of a serious allergic reaction, including: rash, itching/swelling||
8111|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8111|070|S|breathing.||
8111|071|S|   This is not a complete list of possible side effects. If you||
8111|072|S|notice other effects not listed above, contact your doctor or||
8111|073|S|pharmacist.||
8111|074|S|   In the US -||
8111|075|S|   Call your doctor for medical advice about side effects. You||
8111|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8111|077|S|www.fda.gov/medwatch.||
8111|078|S|   In Canada - Call your doctor for medical advice about side||
8111|079|S|effects. You may report side effects to Health Canada at||
8111|080|S|1-866-234-2345.||
8111|081|B|||
8111|082|P|PRECAUTIONS:  Before taking colestipol, tell your doctor or||
8111|083|P|pharmacist if you are allergic to it; or if you have any other||
8111|084|P|allergies. This product may contain inactive ingredients, which||
8111|085|P|can cause allergic reactions or other problems. Talk to your||
8111|086|P|pharmacist for more details.||
8111|087|P|   Before using this medication, tell your doctor or pharmacist||
8111|088|P|your medical history, especially of: swallowing problems,||
8111|089|P|constipation, hemorrhoids, kidney disease.||
8111|090|P|   Because this drug can interfere with the absorption of certain||
8111|091|P|nutrients (such as folic acid, fat-soluble vitamins including A,||
8111|092|P|D, E, K), your doctor may direct you to take a multivitamin||
8111|093|P|supplement. Consult your doctor for more information.||
8111|094|P|   Before having surgery, tell your doctor or dentist about all||
8111|095|P|the products you use (including prescription drugs,||
8111|096|P|nonprescription drugs, and herbal products).||
8111|097|P|   Older adults may be more sensitive to the side effects of this||
8111|098|P|drug, especially constipation.||
8111|099|P|   During pregnancy, this medication should be used only when||
8111|100|P|clearly needed. It may affect the absorption of certain||
8111|101|P|nutrients. Discuss the risks and benefits with your doctor.||
8111|102|P|   This medication is unlikely to pass into breast milk. However,||
8111|103|P|it may affect the absorption of certain nutrients. Consult your||
8111|104|P|doctor before breastfeeding.||
8111|105|B|||
8111|106|I|DRUG INTERACTIONS:  See also How to Use section.||
8111|107|I|   Drug interactions may change how your medications work or||
8111|108|I|increase your risk for serious side effects. This document does||
8111|109|I|not contain all possible drug interactions. Keep a list of all||
8111|110|I|the products you use (including prescription/nonprescription||
8111|111|I|drugs and herbal products) and share it with your doctor and||
8111|112|I|pharmacist. Do not start, stop, or change the dosage of any||
8111|113|I|medicines without your doctor's approval.||
8111|114|I|   Some products that may interact with this drug include: "blood||
8111|115|I|thinners" (such as warfarin), mycophenolate, raloxifene.||
8111|116|B|||
8111|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8111|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8111|119|O|poison control center right away. US residents can call||
8111|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8111|121|O|Symptoms of overdose may include: severe stomach/abdominal pain.||
8111|122|B|||
8111|123|N|NOTES:  Do not share this medication with others.||
8111|124|N|   Lab and/or medical tests (such as blood||
8111|125|N|cholesterol/triglyceride levels, vitamin levels) should be done||
8111|126|N|while you are taking this medication. Keep all medical and lab||
8111|127|N|appointments. Consult your doctor for more details.||
8111|128|B|||
8111|129|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8111|130|D|remember. If it is near the time of the next dose, skip the||
8111|131|D|missed dose. Take your next dose at the regular time. Do not||
8111|132|D|double the dose to catch up.||
8111|133|B|||
8111|134|R|STORAGE:  Store at room temperature away from light and moisture.||
8111|135|R|Do not store in the bathroom. Keep all medications away from||
8111|136|R|children and pets.||
8111|137|R|   Do not flush medications down the toilet or pour them into a||
8111|138|R|drain unless instructed to do so. Properly discard this product||
8111|139|R|when it is expired or no longer needed. Consult your pharmacist||
8111|140|R|or local waste disposal company.||
8111|141|B|||
8111|142|A|Information last revised May 2024.||
8111|143|A|Copyright(c) 2025 First Databank, Inc.||
8111|144|B|||
8113|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8113|002|Z|does NOT have all possible information about this product. This||
8113|003|Z|information does not assure that this product is safe, effective,||
8113|004|Z|or appropriate for you. This information is not individual||
8113|005|Z|medical advice and does not substitute for the advice of your||
8113|006|Z|health care professional. Always ask your health care||
8113|007|Z|professional for complete information about this product and your||
8113|008|Z|specific health needs.||
8113|009|B|||
8113|010|T|PINAVERIUM - ORAL||
8113|011|F|(pin-uh-VARE-ee-um)||
8113|012|B|||
8113|013|U|USES:  This medication is used to treat symptoms of irritable||
8113|014|U|bowel syndrome, including stomach pain, irregular bowels (such as||
8113|015|U|constipation or diarrhea), and bloating. It is also used for||
8113|016|U|symptoms related to other intestinal disorders (involving the||
8113|017|U|gallbladder and bile duct). Pinaverium works by relaxing the||
8113|018|U|muscles that line your intestines.||
8113|019|B|||
8113|020|H|HOW TO USE:  Take this medication by mouth with food as directed||
8113|021|H|by your doctor, usually 3 times daily. This medication can||
8113|022|H|irritate the esophagus. To lessen the chance of irritation, take||
8113|023|H|this medication with a full glass of water (8 ounces or 240||
8113|024|H|milliliters). Do not lie down while taking this medication or for||
8113|025|H|at least 10 minutes afterward.||
8113|026|H|   Dosage is based on your medical condition and response to||
8113|027|H|treatment.||
8113|028|H|   Use this medication regularly to get the most benefit from it.||
8113|029|H|To help you remember, take it at the same times each day.||
8113|030|H|   Tell your doctor if your condition lasts or gets worse.||
8113|031|B|||
8113|032|S|SIDE EFFECTS:  Stomach pain/fullness, nausea, constipation,||
8113|033|S|diarrhea, heartburn, headache, dry mouth, drowsiness, or||
8113|034|S|dizziness may occur. If any of these effects last or get worse,||
8113|035|S|tell your doctor or pharmacist promptly.||
8113|036|S|   Remember that this medication has been prescribed because your||
8113|037|S|doctor has judged that the benefit to you is greater than the||
8113|038|S|risk of side effects. Many people using this medication do not||
8113|039|S|have serious side effects.||
8113|040|S|   Tell your doctor right away if you have any serious side||
8113|041|S|effects, including: throat pain, heartburn.||
8113|042|S|   A very serious allergic reaction to this drug is rare.||
8113|043|S|However, get medical help right away if you notice any symptoms||
8113|044|S|of a serious allergic reaction, including: rash, itching/swelling||
8113|045|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8113|046|S|breathing.||
8113|047|S|   This is not a complete list of possible side effects. If you||
8113|048|S|notice other effects not listed above, contact your doctor or||
8113|049|S|pharmacist.||
8113|050|S|   In the US -||
8113|051|S|   Call your doctor for medical advice about side effects. You||
8113|052|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8113|053|S|www.fda.gov/medwatch.||
8113|054|S|   In Canada - Call your doctor for medical advice about side||
8113|055|S|effects. You may report side effects to Health Canada at||
8113|056|S|1-866-234-2345.||
8113|057|B|||
8113|058|P|PRECAUTIONS:  Before taking pinaverium, tell your doctor or||
8113|059|P|pharmacist if you are allergic to it; or if you have any other||
8113|060|P|allergies. This product may contain inactive ingredients, which||
8113|061|P|can cause allergic reactions or other problems. Talk to your||
8113|062|P|pharmacist for more details.||
8113|063|P|   Before using this medication, tell your doctor or pharmacist||
8113|064|P|your medical history, especially of: other stomach/intestine||
8113|065|P|problems (motility disorders).||
8113|066|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8113|067|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8113|068|P|machinery, or do anything that needs alertness until you can do||
8113|069|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8113|070|P|are using marijuana (cannabis).||
8113|071|P|   Before having surgery, tell your doctor or dentist about all||
8113|072|P|the products you use (including prescription drugs,||
8113|073|P|nonprescription drugs, and herbal products).||
8113|074|P|   During pregnancy, this medication should be used only when||
8113|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
8113|076|P|   It is unknown if this drug passes into breast milk. Consult||
8113|077|P|your doctor before breastfeeding.||
8113|078|B|||
8113|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8113|080|I|medications work or increase your risk for serious side effects.||
8113|081|I|This document does not contain all possible drug interactions.||
8113|082|I|Keep a list of all the products you use (including||
8113|083|I|prescription/nonprescription drugs and herbal products) and share||
8113|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
8113|085|I|the dosage of any medicines without your doctor's approval.||
8113|086|I|   Some products that may interact with this drug include:||
8113|087|I|phenothiazines (such as chlorpromazine, thioridazine), potassium||
8113|088|I|tablets/capsules, pramlintide.||
8113|089|B|||
8113|090|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8113|091|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8113|092|O|poison control center right away. US residents can call||
8113|093|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8113|094|O|Symptoms of overdose may include: diarrhea, gas.||
8113|095|B|||
8113|096|N|NOTES:  Do not share this medication with others.||
8113|097|B|||
8113|098|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8113|099|D|remember. If it is near the time of the next dose, skip the||
8113|100|D|missed dose. Take your next dose at the regular time. Do not||
8113|101|D|double the dose to catch up.||
8113|102|B|||
8113|103|R|STORAGE:  Store at room temperature away from light and moisture.||
8113|104|R|Do not store in the bathroom. Keep all medications away from||
8113|105|R|children and pets.||
8113|106|R|   Do not flush medications down the toilet or pour them into a||
8113|107|R|drain unless instructed to do so. Properly discard this product||
8113|108|R|when it is expired or no longer needed. Consult your pharmacist||
8113|109|R|or local waste disposal company.||
8113|110|B|||
8113|111|A|Information last revised May 2024.||
8113|112|A|Copyright(c) 2025 First Databank, Inc.||
8113|113|B|||
8115|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8115|002|Z|does NOT have all possible information about this product. This||
8115|003|Z|information does not assure that this product is safe, effective,||
8115|004|Z|or appropriate for you. This information is not individual||
8115|005|Z|medical advice and does not substitute for the advice of your||
8115|006|Z|health care professional. Always ask your health care||
8115|007|Z|professional for complete information about this product and your||
8115|008|Z|specific health needs.||
8115|009|B|||
8115|010|T|NORETHINDRONE CONTRACEPTIVE - ORAL||
8115|011|F|(nor-ETH-in-drone)||
8115|012|B|||
8115|013|C|COMMON BRAND NAME(S): Micronor, Nor-Q-D||
8115|014|B|||
8115|015|U|USES:  This medication is used to prevent pregnancy. It is often||
8115|016|U|referred to as the "mini-pill" because it does not contain any||
8115|017|U|estrogen. Norethindrone (a form of progestin) is a hormone that||
8115|018|U|prevents pregnancy.||
8115|019|U|   While the "mini-pill" is more effective than certain other||
8115|020|U|methods of birth control (such as condoms, cervical cap,||
8115|021|U|diaphragm), it is less effective than combination hormone||
8115|022|U|(estrogen and progestin) birth control because it does not||
8115|023|U|consistently prevent ovulation. It is usually used by women who||
8115|024|U|cannot take estrogen. To reduce the risk of pregnancy, it is very||
8115|025|U|important to take this medication exactly as prescribed.||
8115|026|U|   This medication does not protect against sexually transmitted||
8115|027|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
8115|028|U|an effective barrier method (latex or polyurethane condom/dental||
8115|029|U|dams) during sexual activity will help to decrease your risk of||
8115|030|U|infection.||
8115|031|B|||
8115|032|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
8115|033|H|your pharmacist before you start using this product and each time||
8115|034|H|you get a refill. The leaflet contains very important information||
8115|035|H|on when to take your pills and what to do if you miss a dose. If||
8115|036|H|you have any questions, ask your doctor or pharmacist.||
8115|037|H|   Take this medication by mouth as directed by your doctor,||
8115|038|H|usually once daily. Pick a time of day that is easy for you to||
8115|039|H|remember, and take your pill at the same time each day.||
8115|040|H|   Taking this medication after your evening meal or at bedtime||
8115|041|H|may help if you have stomach upset or nausea with the medication.||
8115|042|H|You may choose to take this medication at another time of day||
8115|043|H|that is easier for you to remember. No matter what dosing||
8115|044|H|schedule you use, it is very important that you take this||
8115|045|H|medication at the same time each day, 24 hours apart.||
8115|046|H|   It is best to begin taking this medication on the first day of||
8115|047|H|your menstrual period. If you begin taking it on any other day,||
8115|048|H|use a backup form of non-hormonal birth control (such as condoms,||
8115|049|H|spermicide) for the first 48 hours to prevent pregnancy until the||
8115|050|H|medication has enough time to work.||
8115|051|H|   Keep taking one tablet every day. After taking the last tablet||
8115|052|H|in a pack, start a new pack the next day. There is no break||
8115|053|H|between packs, and you do not take any "reminder" tablets||
8115|054|H|(tablets without medication). Your periods may be irregular, or||
8115|055|H|heavier/lighter than usual. You may also have vaginal bleeding||
8115|056|H|(spotting) between periods. Do not stop taking your pills if this||
8115|057|H|happens.||
8115|058|H|   Pregnancy is more likely if you miss pills, start a new pack||
8115|059|H|late, or take your pill at a different time of the day than||
8115|060|H|usual. If you miss a pill, or take it 3 or more hours later than||
8115|061|H|usual, or have diarrhea, or vomit soon after taking a pill, use a||
8115|062|H|backup method of birth control (such as condoms, spermicide)||
8115|063|H|every time you have sex for the next 48 hours.||
8115|064|H|   Ask your doctor or pharmacist about how to switch from other||
8115|065|H|forms of hormonal birth control (such as patch, other birth||
8115|066|H|control pills) to this product. If any information is unclear,||
8115|067|H|consult the Patient Information Leaflet or your doctor or||
8115|068|H|pharmacist.||
8115|069|B|||
8115|070|S|SIDE EFFECTS:  Nausea, vomiting, headache, bloating, breast||
8115|071|S|tenderness, or weight gain may occur. Vaginal bleeding between||
8115|072|S|periods (spotting) or missed/irregular periods may occur. If any||
8115|073|S|of these effects last or get worse, tell your doctor or||
8115|074|S|pharmacist promptly. If you miss 2 periods in a row (or 1 period||
8115|075|S|if the pill has not been used properly), contact your doctor for||
8115|076|S|a pregnancy test.||
8115|077|S|   Remember that this medication has been prescribed because your||
8115|078|S|doctor has judged that the benefit to you is greater than the||
8115|079|S|risk of side effects. Many people using this medication do not||
8115|080|S|have serious side effects.||
8115|081|S|   Tell your doctor right away if you have any serious side||
8115|082|S|effects, including: lumps in the breast, mental/mood changes||
8115|083|S|(such as new/worsening depression), severe stomach/abdominal||
8115|084|S|pain, unusual changes in vaginal bleeding (such as continuous||
8115|085|S|spotting, sudden heavy bleeding, missed periods), dark urine,||
8115|086|S|yellowing eyes/skin.||
8115|087|S|   A very serious allergic reaction to this drug is rare.||
8115|088|S|However, get medical help right away if you notice any symptoms||
8115|089|S|of a serious allergic reaction, including: rash, itching/swelling||
8115|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8115|091|S|breathing.||
8115|092|S|   This is not a complete list of possible side effects. If you||
8115|093|S|notice other effects not listed above, contact your doctor or||
8115|094|S|pharmacist.||
8115|095|S|   In the US -||
8115|096|S|   Call your doctor for medical advice about side effects. You||
8115|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8115|098|S|www.fda.gov/medwatch.||
8115|099|S|   In Canada - Call your doctor for medical advice about side||
8115|100|S|effects. You may report side effects to Health Canada at||
8115|101|S|1-866-234-2345.||
8115|102|B|||
8115|103|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
8115|104|P|pharmacist if you are allergic to norethindrone; or to other||
8115|105|P|progestins; or if you have any other allergies. This product may||
8115|106|P|contain inactive ingredients, which can cause allergic reactions||
8115|107|P|or other problems. Talk to your pharmacist for more details.||
8115|108|P|   Before using this medication, tell your doctor or pharmacist||
8115|109|P|your medical history, especially of: abnormal breast exam, cancer||
8115|110|P|(especially endometrial or breast cancer), low levels of "good"||
8115|111|P|cholesterol (HDL), depression, diabetes, severe||
8115|112|P|headaches/migraines, history of yellowing eyes/skin (jaundice)||
8115|113|P|during pregnancy or while using hormonal birth control (such as||
8115|114|P|pills, patch), liver disease (including tumors), unexplained||
8115|115|P|vaginal bleeding.||
8115|116|P|   Before having surgery, tell your doctor or dentist about all||
8115|117|P|the products you use (including prescription drugs,||
8115|118|P|nonprescription drugs, and herbal products).||
8115|119|P|   This medication may cause blotchy, dark areas on your face and||
8115|120|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
8115|121|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
8115|122|P|wear protective clothing when outdoors.||
8115|123|P|   This medication should not be used during pregnancy. If you||
8115|124|P|become pregnant or think you may be pregnant, tell your doctor||
8115|125|P|right away.||
8115|126|P|   This medication passes into breast milk. Consult your doctor||
8115|127|P|before breastfeeding.||
8115|128|B|||
8115|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8115|130|I|medications work or increase your risk for serious side effects.||
8115|131|I|This document does not contain all possible drug interactions.||
8115|132|I|Keep a list of all the products you use (including||
8115|133|I|prescription/nonprescription drugs and herbal products) and share||
8115|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
8115|135|I|the dosage of any medicines without your doctor's approval.||
8115|136|I|   Some drugs may cause hormonal birth control to work less well||
8115|137|I|by decreasing the amount of birth control hormones in your body.||
8115|138|I|This effect can result in pregnancy. Examples include||
8115|139|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
8115|140|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
8115|141|I|seizures (such as barbiturates, carbamazepine, felbamate,||
8115|142|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
8115|143|I|nevirapine), among others.||
8115|144|I|   Tell your doctor when you start any new drug, and discuss if||
8115|145|I|you should use reliable backup birth control. Also tell your||
8115|146|I|doctor if you have any new spotting or breakthrough bleeding,||
8115|147|I|because these may be signs that your birth control is not working||
8115|148|I|well.||
8115|149|I|   This medication may interfere with certain lab tests (such as||
8115|150|I|sex hormone-binding globulin, thyroid), possibly causing false||
8115|151|I|test results. Make sure lab personnel and all your doctors know||
8115|152|I|you use this drug.||
8115|153|B|||
8115|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8115|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8115|156|O|poison control center right away. US residents can call||
8115|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8115|158|O|Symptoms of overdose may include severe nausea, vomiting,||
8115|159|O|sudden/unusual vaginal bleeding.||
8115|160|B|||
8115|161|N|NOTES:  Do not share this medication with others.||
8115|162|N|   Regular complete physical exams which include lab and/or||
8115|163|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
8115|164|N|Pap smear) should be done while you are taking this medication.||
8115|165|N|Follow your doctor's instructions for examining your breasts, and||
8115|166|N|report any lumps right away. Keep all medical and lab||
8115|167|N|appointments. Consult your doctor for more details.||
8115|168|B|||
8115|169|D|MISSED DOSE:  Refer to the product package information for advice||
8115|170|D|on missed doses. You may need to use backup birth control (such||
8115|171|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
8115|172|D|pharmacist if you have any questions.||
8115|173|D|   If you often forget to take your pills as directed, contact||
8115|174|D|your doctor to discuss switching to another form of birth||
8115|175|D|control.||
8115|176|B|||
8115|177|R|STORAGE:  Store at room temperature away from light and moisture.||
8115|178|R|Do not store in the bathroom. Keep all medications away from||
8115|179|R|children and pets.||
8115|180|R|   Do not flush medications down the toilet or pour them into a||
8115|181|R|drain unless instructed to do so. Properly discard this product||
8115|182|R|when it is expired or no longer needed. Consult your pharmacist||
8115|183|R|or local waste disposal company.||
8115|184|B|||
8115|185|A|Information last revised October 2025.||
8115|186|A|Copyright(c) 2025 First Databank, Inc.||
8115|187|B|||
8116|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8116|002|Z|does NOT have all possible information about this product. This||
8116|003|Z|information does not assure that this product is safe, effective,||
8116|004|Z|or appropriate for you. This information is not individual||
8116|005|Z|medical advice and does not substitute for the advice of your||
8116|006|Z|health care professional. Always ask your health care||
8116|007|Z|professional for complete information about this product and your||
8116|008|Z|specific health needs.||
8116|009|B|||
8116|010|T|TESTOSTERONE - INTRAMUSCULAR||
8116|011|F|(tess-TOSS-ter-own)||
8116|012|B|||
8116|013|C|COMMON BRAND NAME(S): Azmiro, Delatestryl, Tesamone||
8116|014|B|||
8116|015|U|USES:  This medication is used in men who do not make enough of a||
8116|016|U|natural substance called testosterone. In males, testosterone is||
8116|017|U|responsible for many normal functions, including growth and||
8116|018|U|development of the genitals, muscles, and bones. It also helps||
8116|019|U|cause normal sexual development (puberty) in boys. Testosterone||
8116|020|U|belongs to a class of drugs known as androgens. It works by||
8116|021|U|affecting many body systems so that the body can develop and||
8116|022|U|function normally.||
8116|023|U|   Testosterone may also be used in certain adolescent boys to||
8116|024|U|cause puberty in those with delayed puberty. Some brands may also||
8116|025|U|be used to treat certain types of breast cancer in women.||
8116|026|B|||
8116|027|H|HOW TO USE:  Some brands of this medication have a Medication||
8116|028|H|Guide provided by your pharmacist. If one is available, read the||
8116|029|H|Medication Guide before your start taking this medication and||
8116|030|H|each time you get a refill. If you have any questions, consult||
8116|031|H|your doctor or pharmacist.||
8116|032|H|   This medication is given by injection into the buttock muscle||
8116|033|H|as directed by your doctor, usually every 1 to 4 weeks. Do not||
8116|034|H|inject this medication into a vein. The dosage is based on your||
8116|035|H|medical condition, testosterone blood levels, and response to||
8116|036|H|treatment.||
8116|037|H|   If you are giving this medication to yourself at home, learn||
8116|038|H|all preparation and usage instructions from your health care||
8116|039|H|professional. Before using, check this product for particles or||
8116|040|H|discoloration. If either is present, do not use the liquid. Learn||
8116|041|H|how to store and discard medical supplies safely.||
8116|042|H|   Use this medication regularly to get the most benefit from it.||
8116|043|H|To help you remember, mark your calendar with a reminder.||
8116|044|H|   Misuse or abuse of testosterone can cause serious side effects||
8116|045|H|such as heart disease (including heart attack), stroke, liver||
8116|046|H|disease, mental/mood problems, abnormal drug-seeking behavior, or||
8116|047|H|improper bone growth (in adolescents). Do not increase your dose||
8116|048|H|or use this drug more often or for longer than prescribed. When||
8116|049|H|testosterone is misused or abused, you may have withdrawal||
8116|050|H|symptoms (such as depression, irritability, tiredness) when you||
8116|051|H|suddenly stop using the drug. These symptoms may last from weeks||
8116|052|H|to months.||
8116|053|H|   Tell your doctor if your condition does not get better or if||
8116|054|H|it gets worse.||
8116|055|B|||
8116|056|S|SIDE EFFECTS:  Nausea, vomiting, headache, skin color changes,||
8116|057|S|increased/decreased sexual interest, oily skin, hair loss, and||
8116|058|S|acne may occur. Pain and redness at the injection site may also||
8116|059|S|occur. If any of these effects last or get worse, tell your||
8116|060|S|doctor or pharmacist promptly.||
8116|061|S|   Remember that this medication has been prescribed because your||
8116|062|S|doctor has judged that the benefit to you is greater than the||
8116|063|S|risk of side effects. Many people using this medication do not||
8116|064|S|have serious side effects.||
8116|065|S|   This medication may raise your blood pressure. Check your||
8116|066|S|blood pressure regularly and tell your doctor if the results are||
8116|067|S|high. Your doctor may control your blood pressure with||
8116|068|S|medication.||
8116|069|S|   Tell your doctor right away if you have any serious side||
8116|070|S|effects, including: mental/mood changes (such as anxiety,||
8116|071|S|depression, increased anger), trouble sleeping/snoring, signs of||
8116|072|S|liver disease (such as nausea/vomiting that doesn't stop, loss of||
8116|073|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
8116|074|S|urine), hands/ankles/feet swelling, unusual tiredness,||
8116|075|S|fast/irregular heartbeat.||
8116|076|S|   Get medical help right away if you have any very serious side||
8116|077|S|effects, including: shortness of breath/rapid breathing,||
8116|078|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
8116|079|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
8116|080|S|sudden/severe headaches, trouble speaking, weakness on one side||
8116|081|S|of the body, sudden vision changes.||
8116|082|S|   If you are male, tell your doctor right away if you have any||
8116|083|S|serious side effects, including: trouble urinating, increased||
8116|084|S|urination (especially at night), breast swelling/tenderness, too||
8116|085|S|frequent/prolonged erections.||
8116|086|S|   Rarely, males may have a painful or prolonged erection lasting||
8116|087|S|4 or more hours. If this occurs, stop using this drug and get||
8116|088|S|medical help right away, or permanent problems could occur.||
8116|089|S|   If you are female, tell your doctor right away if you have any||
8116|090|S|serious side effects, including: deepening of the voice,||
8116|091|S|hoarseness, unusual facial/body hair growth, enlarged clitoris,||
8116|092|S|irregular menstrual periods.||
8116|093|S|   A very serious allergic reaction to this drug is rare.||
8116|094|S|However, get medical help right away if you notice any symptoms||
8116|095|S|of a serious allergic reaction, including: rash, itching/swelling||
8116|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8116|097|S|breathing.||
8116|098|S|   This is not a complete list of possible side effects. If you||
8116|099|S|notice other effects not listed above, contact your doctor or||
8116|100|S|pharmacist.||
8116|101|S|   In the US -||
8116|102|S|   Call your doctor for medical advice about side effects. You||
8116|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8116|104|S|www.fda.gov/medwatch.||
8116|105|S|   In Canada - Call your doctor for medical advice about side||
8116|106|S|effects. You may report side effects to Health Canada at||
8116|107|S|1-866-234-2345.||
8116|108|B|||
8116|109|P|PRECAUTIONS:  Before using testosterone, tell your doctor or||
8116|110|P|pharmacist if you are allergic to it; or if you have any other||
8116|111|P|allergies. This product may contain inactive ingredients (such as||
8116|112|P|sesame oil in some brands), which can cause allergic reactions or||
8116|113|P|other problems. Talk to your pharmacist for more details.||
8116|114|P|   Before using this medication, tell your doctor or pharmacist||
8116|115|P|your medical history, especially of: cancer (such as breast||
8116|116|P|cancer in men, prostate cancer), blood clots (such as in the leg,||
8116|117|P|lungs), heart disease (such as heart failure, chest pain, heart||
8116|118|P|attack), stroke, liver problems, kidney problems, high||
8116|119|P|cholesterol, high blood pressure, enlarged prostate, sleep apnea,||
8116|120|P|diabetes.||
8116|121|P|   If you have diabetes, this product may lower your blood sugar.||
8116|122|P|Check your blood sugar regularly as directed and share the||
8116|123|P|results with your doctor. Tell your doctor right away if you have||
8116|124|P|symptoms of low blood sugar, such as sudden sweating, shaking,||
8116|125|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
8116|126|P|hands/feet. Your doctor may need to adjust your diabetes||
8116|127|P|medication, exercise program, or diet.||
8116|128|P|   Before having surgery, tell your doctor or dentist about all||
8116|129|P|the products you use (including prescription drugs,||
8116|130|P|nonprescription drugs, and herbal products).||
8116|131|P|   Children may be more sensitive to the side effects of this||
8116|132|P|drug. In children, it may affect bone growth. Check your child's||
8116|133|P|height periodically.||
8116|134|P|   Older adults may be more sensitive to the side effects of this||
8116|135|P|drug, especially prostate/liver problems, swelling of arms/legs.||
8116|136|P|   This medication can affect fertility in males. Ask your doctor||
8116|137|P|for more details.||
8116|138|P|   This medication must not be used during pregnancy. It may harm||
8116|139|P|an unborn baby. Discuss the use of reliable forms of birth||
8116|140|P|control (such as condoms, birth control pills) with your doctor.||
8116|141|P|If you become pregnant or think you may be pregnant, tell your||
8116|142|P|doctor right away.||
8116|143|P|   It is unknown if this drug passes into breast milk. Because of||
8116|144|P|the possible risk to the infant, breastfeeding is not recommended||
8116|145|P|while using this drug. Consult your doctor before breastfeeding.||
8116|146|B|||
8116|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8116|148|I|medications work or increase your risk for serious side effects.||
8116|149|I|This document does not contain all possible drug interactions.||
8116|150|I|Keep a list of all the products you use (including||
8116|151|I|prescription/nonprescription drugs and herbal products) and share||
8116|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
8116|153|I|the dosage of any medicines without your doctor's approval.||
8116|154|I|   Some products that may interact with this drug include: "blood||
8116|155|I|thinners" (such as warfarin).||
8116|156|I|   This medication may interfere with certain lab tests (such as||
8116|157|I|thyroid tests), possibly causing false test results. Make sure||
8116|158|I|lab personnel and all your doctors know you use this drug.||
8116|159|B|||
8116|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8116|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8116|162|O|poison control center right away. US residents can call||
8116|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8116|164|B|||
8116|165|N|NOTES:  Do not share this medication with others. Sharing it is||
8116|166|N|against the law.||
8116|167|N|   Lab and/or medical tests (such as blood testosterone levels,||
8116|168|N|red blood cell counts, liver function, blood cholesterol levels,||
8116|169|N|PSA test) should be done while you are using this medication.||
8116|170|N|Keep all medical and lab appointments. Consult your doctor for||
8116|171|N|more details.||
8116|172|B|||
8116|173|D|MISSED DOSE:  It is important to get each dose of this medication||
8116|174|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8116|175|D|right away for a new dosing schedule. Do not double the dose to||
8116|176|D|catch up.||
8116|177|B|||
8116|178|R|STORAGE:  Store at room temperature away from light. Keep all||
8116|179|R|medications away from children and pets.||
8116|180|R|   Do not flush medications down the toilet or pour them into a||
8116|181|R|drain unless instructed to do so. Properly discard this product||
8116|182|R|when it is expired or no longer needed. Consult your pharmacist||
8116|183|R|or local waste disposal company.||
8116|184|B|||
8116|185|A|Information last revised March 2025.||
8116|186|A|Copyright(c) 2025 First Databank, Inc.||
8116|187|B|||
8117|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8117|002|Z|does NOT have all possible information about this product. This||
8117|003|Z|information does not assure that this product is safe, effective,||
8117|004|Z|or appropriate for you. This information is not individual||
8117|005|Z|medical advice and does not substitute for the advice of your||
8117|006|Z|health care professional. Always ask your health care||
8117|007|Z|professional for complete information about this product and your||
8117|008|Z|specific health needs.||
8117|009|B|||
8117|010|T|LEUCOVORIN - INJECTION||
8117|011|F|(LOO-koe-VOR-in)||
8117|012|B|||
8117|013|U|USES:  This medication is used to treat or prevent serious blood||
8117|014|U|cell disorders (such as thrombocytopenia, neutropenia, anemia)||
8117|015|U|caused by certain drugs (folic acid antagonists such as||
8117|016|U|methotrexate, trimethoprim, pyrimethamine). It may also be used||
8117|017|U|with a certain cancer drug (5-fluorouracil) to treat patients||
8117|018|U|with colon cancer.||
8117|019|U|   Leucovorin may also be used to treat a certain type of anemia||
8117|020|U|(due to folic acid deficiency) when folic acid cannot be taken by||
8117|021|U|mouth.||
8117|022|B|||
8117|023|H|HOW TO USE:  This medication is given by injection into a vein or||
8117|024|H|a muscle as directed by your doctor, usually every 6 hours or||
8117|025|H|once daily. Do not inject this medication into the spine.||
8117|026|H|   The dosage is based on your medical condition and response to||
8117|027|H|treatment. Use this medication regularly to get the most benefit||
8117|028|H|from it.||
8117|029|H|   If you are using this medication at home, learn all||
8117|030|H|preparation and usage instructions from your health care||
8117|031|H|professional and the product package. Before using, check this||
8117|032|H|product for particles or discoloration. If either is present, do||
8117|033|H|not use the liquid. Learn how to store and discard medical||
8117|034|H|supplies safely.||
8117|035|B|||
8117|036|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
8117|037|S|because your doctor has judged that the benefit to you is greater||
8117|038|S|than the risk of side effects. Many people using this medication||
8117|039|S|do not have serious side effects.||
8117|040|S|   A very serious allergic reaction to this drug is rare.||
8117|041|S|However, get medical help right away if you notice any symptoms||
8117|042|S|of a serious allergic reaction, including: rash, itching/swelling||
8117|043|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8117|044|S|breathing.||
8117|045|S|   This is not a complete list of possible side effects. If you||
8117|046|S|notice other effects not listed above, contact your doctor or||
8117|047|S|pharmacist.||
8117|048|S|   In the US -||
8117|049|S|   Call your doctor for medical advice about side effects. You||
8117|050|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8117|051|S|www.fda.gov/medwatch.||
8117|052|S|   In Canada - Call your doctor for medical advice about side||
8117|053|S|effects. You may report side effects to Health Canada at||
8117|054|S|1-866-234-2345.||
8117|055|B|||
8117|056|P|PRECAUTIONS:  Before using leucovorin, tell your doctor or||
8117|057|P|pharmacist if you are allergic to it; or to levoleucovorin; or to||
8117|058|P|folic acid or folinic acid; or if you have any other allergies.||
8117|059|P|This product may contain inactive ingredients, which can cause||
8117|060|P|allergic reactions or other problems. Talk to your pharmacist for||
8117|061|P|more details.||
8117|062|P|   Before using this medication, tell your doctor or pharmacist||
8117|063|P|your medical history, especially of: certain anemias (due to||
8117|064|P|vitamin B12 deficiency).||
8117|065|P|   Before having surgery, tell your doctor or dentist about all||
8117|066|P|the products you use (including prescription drugs,||
8117|067|P|nonprescription drugs, and herbal products).||
8117|068|P|   During pregnancy, this medication should be used only when||
8117|069|P|clearly needed. Discuss the risks and benefits with your doctor.||
8117|070|P|   It is unknown if this medication passes into breast milk.||
8117|071|P|Consult your doctor before breastfeeding.||
8117|072|B|||
8117|073|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8117|074|I|medications work or increase your risk for serious side effects.||
8117|075|I|This document does not contain all possible drug interactions.||
8117|076|I|Keep a list of all the products you use (including||
8117|077|I|prescription/nonprescription drugs and herbal products) and share||
8117|078|I|it with your doctor and pharmacist. Do not start, stop, or change||
8117|079|I|the dosage of any medicines without your doctor's approval.||
8117|080|I|   Leucovorin is very similar to levoleucovorin. Do not use||
8117|081|I|medications containing levoleucovorin while using leucovorin.||
8117|082|B|||
8117|083|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8117|084|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8117|085|O|poison control center right away. US residents can call||
8117|086|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8117|087|B|||
8117|088|N|NOTES:  Do not share this medication with others.||
8117|089|N|   Lab and/or medical tests (such as kidney function, complete||
8117|090|N|blood count, folic acid antagonist blood levels) should be done||
8117|091|N|while you are using this medication. Keep all medical and lab||
8117|092|N|appointments. Consult your doctor for more details.||
8117|093|B|||
8117|094|D|MISSED DOSE:  It is important to get each dose of this medication||
8117|095|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8117|096|D|right away for a new dosing schedule. Do not double the dose to||
8117|097|D|catch up.||
8117|098|B|||
8117|099|R|STORAGE:  Different brands of this medication have different||
8117|100|R|storage needs. Check the product package for instructions on how||
8117|101|R|to store your brand, or ask your pharmacist. Keep all medications||
8117|102|R|away from children and pets.||
8117|103|R|   Do not flush medications down the toilet or pour them into a||
8117|104|R|drain unless instructed to do so. Properly discard this product||
8117|105|R|when it is expired or no longer needed. Consult your pharmacist||
8117|106|R|or local waste disposal company.||
8117|107|B|||
8117|108|A|Information last revised November 2024.||
8117|109|A|Copyright(c) 2025 First Databank, Inc.||
8117|110|B|||
8118|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8118|002|Z|does NOT have all possible information about this product. This||
8118|003|Z|information does not assure that this product is safe, effective,||
8118|004|Z|or appropriate for you. This information is not individual||
8118|005|Z|medical advice and does not substitute for the advice of your||
8118|006|Z|health care professional. Always ask your health care||
8118|007|Z|professional for complete information about this product and your||
8118|008|Z|specific health needs.||
8118|009|B|||
8118|010|T|HYDROCODONE/HOMATROPINE - ORAL||
8118|011|F|(HYE-droe-KOE-done/hoe-MAT-roe-peen)||
8118|012|B|||
8118|013|C|COMMON BRAND NAME(S): Hycodan, Tussigon||
8118|014|B|||
8118|015|W|WARNING:  This medication has a risk for abuse and addiction,||
8118|016|W|which can lead to overdose and death. This medication may also||
8118|017|W|cause severe, possibly fatal, breathing problems. To lower your||
8118|018|W|risk, your doctor should have you take the smallest dose that||
8118|019|W|works, and take it for the shortest possible time. See also How||
8118|020|W|to Use section for more information about addiction.||
8118|021|W|   The risk for severe breathing problems is higher when you||
8118|022|W|start this medication, or if you take the wrong dose or take more||
8118|023|W|of this medication than prescribed. Taking this medication with||
8118|024|W|alcohol or other drugs that can cause drowsiness or breathing||
8118|025|W|problems may cause very serious side effects, including death.||
8118|026|W|Also, other medications can affect the removal of this product||
8118|027|W|from your body, which may affect how it works. Be sure you know||
8118|028|W|how to take this product and what other drugs you should avoid||
8118|029|W|taking with it. See also Drug Interactions section. Get medical||
8118|030|W|help right away if any of these very serious side effects occur:||
8118|031|W|slow/shallow breathing, unusual lightheadedness, severe||
8118|032|W|drowsiness/dizziness, difficulty waking up.||
8118|033|W|   Keep this medicine in a safe place to prevent theft, misuse,||
8118|034|W|or abuse. If someone accidentally swallows this drug, get medical||
8118|035|W|help right away.||
8118|036|W|   Before using this medication, women of childbearing age should||
8118|037|W|talk with their doctor(s) about the risks and benefits. Tell your||
8118|038|W|doctor if you are pregnant or think you may be pregnant. During||
8118|039|W|pregnancy, this medication is not recommended. It may slightly||
8118|040|W|increase the risk of birth defects if used during the first two||
8118|041|W|months of pregnancy. Also, using it for a long time or in high||
8118|042|W|doses near the expected delivery date may harm the unborn baby.||
8118|043|W|To lessen the risk, take the smallest effective dose for the||
8118|044|W|shortest possible time. Babies born to mothers who use this drug||
8118|045|W|for a long time may develop severe (possibly fatal) withdrawal||
8118|046|W|symptoms. Tell the doctor right away if you notice any symptoms||
8118|047|W|in your newborn baby such as crying that doesn't stop,||
8118|048|W|slow/shallow breathing, irritability, shaking, vomiting,||
8118|049|W|diarrhea, poor feeding, or difficulty gaining weight.||
8118|050|B|||
8118|051|U|USES:  This medication is used to relieve a dry cough usually||
8118|052|U|caused by the common cold or other conditions as prescribed by||
8118|053|U|your doctor. Relieving a cough helps you get more rest and sleep.||
8118|054|U|This product contains 2 medications, hydrocodone and homatropine.||
8118|055|U|Hydrocodone is an opioid cough suppressant (antitussive) that||
8118|056|U|works on certain centers in the brain to stop the urge to cough.||
8118|057|U|Homatropine belongs to a class of drugs known as||
8118|058|U|anticholinergics.||
8118|059|U|   This medication is generally used for short-term treatment. It||
8118|060|U|should not be used for ongoing coughs from smoking or long-term||
8118|061|U|breathing problems (such as asthma, emphysema), or for coughs||
8118|062|U|with a lot of mucus or fluids (productive coughs), unless||
8118|063|U|directed by your doctor.||
8118|064|U|   Opioid cough suppressants should not be used by children||
8118|065|U|younger than 18 years. Children are at higher risk for serious||
8118|066|U|(even fatal) side effects, especially breathing problems. Talk||
8118|067|U|with the doctor about the risks and benefits of this medication.||
8118|068|U|   Cough-and-cold products do not cure colds. Cough due to a||
8118|069|U|common cold often does not need to be treated with medicine. Ask||
8118|070|U|your doctor or pharmacist about other ways to relieve cough and||
8118|071|U|cold symptoms, such as drinking enough fluids, using a||
8118|072|U|humidifier, or saline nose drops/spray.||
8118|073|B|||
8118|074|H|HOW TO USE:  Read the Medication Guide provided by your||
8118|075|H|pharmacist before you start taking hydrocodone/homatropine and||
8118|076|H|each time you get a refill. If you have any questions, ask your||
8118|077|H|doctor or pharmacist.||
8118|078|H|   Take this medication by mouth with or without food as directed||
8118|079|H|by your doctor, usually every 4 or 6 hours as needed. The dosage||
8118|080|H|is based on your medical condition and response to treatment.||
8118|081|H|Follow your doctor's directions closely. The manufacturer||
8118|082|H|recommends that adults should not take more than 6 tablets or 6||
8118|083|H|teaspoons (30 milliliters) daily.||
8118|084|H|   If you are taking the syrup, carefully measure the dose using||
8118|085|H|a special measuring device/spoon. Do not use a household spoon||
8118|086|H|because you may not get the correct dose. Ask your doctor or||
8118|087|H|pharmacist if you are not sure how to check or measure the dose.||
8118|088|H|   Do not increase your dose or use this drug more often or for||
8118|089|H|longer than prescribed. Your condition will not improve any||
8118|090|H|faster, and your risk of side effects will increase.||
8118|091|H|   If you suddenly stop using this medication, you may have||
8118|092|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
8118|093|H|nose, nausea, sweating, muscle aches). To help prevent||
8118|094|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
8118|095|H|more likely if you have used this medication for a long time or||
8118|096|H|in high doses. Tell your doctor or pharmacist right away if you||
8118|097|H|have withdrawal.||
8118|098|H|   Though it helps many people, this medication may sometimes||
8118|099|H|cause addiction. This risk may be higher if you have a||
8118|100|H|mental/mood disorder or a substance use disorder (such as overuse||
8118|101|H|of or addiction to drugs/alcohol). Take this medication exactly||
8118|102|H|as prescribed to lower the risk of addiction. Ask your doctor or||
8118|103|H|pharmacist for more details.||
8118|104|H|   When taken for a long time, this medication may not work as||
8118|105|H|well and may require different dosing. Tell your doctor if this||
8118|106|H|medication stops working well.||
8118|107|H|   Tell your doctor if your cough does not get better in 5 days.||
8118|108|B|||
8118|109|S|SIDE EFFECTS:  See also Warning section.||
8118|110|S|   Nausea commonly occurs with the use of hydrocodone and usually||
8118|111|S|goes away after the first few doses. Consult your doctor or||
8118|112|S|pharmacist about ways to decrease nausea (such as taking with||
8118|113|S|food, lying down for 1-2 hours with as little head movement as||
8118|114|S|possible).||
8118|115|S|   Lightheadedness, dizziness, drowsiness, vomiting, and||
8118|116|S|constipation may also occur. If any of these effects last or get||
8118|117|S|worse, tell your doctor or pharmacist promptly.||
8118|118|S|   To prevent constipation, eat dietary fiber, drink enough||
8118|119|S|water, and exercise. You may also need to take a laxative. Ask||
8118|120|S|your pharmacist which type of laxative is right for you.||
8118|121|S|   To reduce the risk of dizziness and lightheadedness, get up||
8118|122|S|slowly when rising from a sitting or lying position.||
8118|123|S|   Remember that this medication has been prescribed because your||
8118|124|S|doctor has judged that the benefit to you is greater than the||
8118|125|S|risk of side effects. Many people using this medication do not||
8118|126|S|have serious side effects.||
8118|127|S|   Tell your doctor right away if you have any serious side||
8118|128|S|effects, including: interrupted breathing during sleep (sleep||
8118|129|S|apnea), trouble swallowing, stomach/abdominal pain, mental/mood||
8118|130|S|changes (such as agitation, confusion, hallucinations),||
8118|131|S|difficult/painful urination.||
8118|132|S|   Get medical help right away if you have any very serious side||
8118|133|S|effects, including: eye pain/swelling/redness, vision changes||
8118|134|S|(such as seeing rainbows around lights at night, blurred vision),||
8118|135|S|slow/shallow/irregular breathing, severe drowsiness/difficulty||
8118|136|S|waking up, seizure, fainting.||
8118|137|S|   A very serious allergic reaction to this drug is rare.||
8118|138|S|However, get medical help right away if you notice any symptoms||
8118|139|S|of a serious allergic reaction, including: rash, itching/swelling||
8118|140|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8118|141|S|breathing.||
8118|142|S|   This is not a complete list of possible side effects. If you||
8118|143|S|notice other effects not listed above, contact your doctor or||
8118|144|S|pharmacist.||
8118|145|S|   In the US -||
8118|146|S|   Call your doctor for medical advice about side effects. You||
8118|147|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8118|148|S|www.fda.gov/medwatch.||
8118|149|S|   In Canada - Call your doctor for medical advice about side||
8118|150|S|effects. You may report side effects to Health Canada at||
8118|151|S|1-866-234-2345.||
8118|152|B|||
8118|153|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
8118|154|P|pharmacist if you are allergic to hydrocodone; or to homatropine;||
8118|155|P|or to other opioid medications (such as codeine, hydromorphone);||
8118|156|P|or if you have any other allergies. This product may contain||
8118|157|P|inactive ingredients, which can cause allergic reactions or other||
8118|158|P|problems. Talk to your pharmacist for more details.||
8118|159|P|   Before using this medication, tell your doctor or pharmacist||
8118|160|P|your medical history, especially of: brain disorders (such as||
8118|161|P|head injury, tumor, seizures), breathing problems (such as||
8118|162|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD,||
8118|163|P|intoxication with medications that can cause drowsiness or||
8118|164|P|slow/shallow breathing), gallbladder disease, kidney disease,||
8118|165|P|liver disease, mental/mood disorders (such as confusion,||
8118|166|P|depression, thoughts of suicide, psychosis), personal or family||
8118|167|P|history of a substance use disorder (such as overuse of or||
8118|168|P|addiction to drugs/alcohol), stomach/intestinal problems (such as||
8118|169|P|blockage, constipation, diarrhea due to infection, paralytic||
8118|170|P|ileus), disease of the pancreas (pancreatitis), difficulty||
8118|171|P|urinating (such as due to enlarged prostate), personal or family||
8118|172|P|history of glaucoma (angle-closure type), adrenal gland problems||
8118|173|P|(such as Addison's disease), recent surgery, underactive thyroid||
8118|174|P|(hypothyroidism).||
8118|175|P|   This drug may make you dizzy or drowsy or blur your vision.||
8118|176|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8118|177|P|drowsy. Do not drive, use machinery, or do anything that needs||
8118|178|P|alertness or clear vision until you can do it safely. Avoid||
8118|179|P|alcoholic beverages. Talk to your doctor if you are using||
8118|180|P|marijuana (cannabis).||
8118|181|P|   Before having surgery, tell your doctor or dentist about all||
8118|182|P|the products you use (including prescription drugs,||
8118|183|P|nonprescription drugs, and herbal products).||
8118|184|P|   Older adults may be more sensitive to the side effects of this||
8118|185|P|drug, especially confusion, dizziness, drowsiness, and||
8118|186|P|slow/shallow breathing.||
8118|187|P|   Tell your doctor if you are pregnant or think you may be||
8118|188|P|pregnant. During pregnancy, this product is not recommended. It||
8118|189|P|may harm an unborn baby. Talk to your doctor about the risks and||
8118|190|P|benefits of this medication. See also Warning section.||
8118|191|P|   This product passes into breast milk and may have undesirable||
8118|192|P|effects on a nursing infant (such as unusual sleepiness,||
8118|193|P|difficulty feeding, trouble breathing, or unusual limpness).||
8118|194|P|Breastfeeding is not recommended while using this product.||
8118|195|P|Consult your doctor before breastfeeding.||
8118|196|B|||
8118|197|I|DRUG INTERACTIONS:  See also Warning section.||
8118|198|I|   Drug interactions may change how your medications work or||
8118|199|I|increase your risk for serious side effects. This document does||
8118|200|I|not contain all possible drug interactions. Keep a list of all||
8118|201|I|the products you use (including prescription/nonprescription||
8118|202|I|drugs and herbal products) and share it with your doctor and||
8118|203|I|pharmacist. Do not start, stop, or change the dosage of any||
8118|204|I|medicines without your doctor's approval.||
8118|205|I|   Some products that may interact with this drug include:||
8118|206|I|certain pain medications (mixed opioid agonist-antagonists such||
8118|207|I|as butorphanol, nalbuphine, pentazocine), naltrexone, potassium||
8118|208|I|tablets/capsules, pramlintide, samidorphan.||
8118|209|I|   The risk of serious side effects (such as slow/shallow||
8118|210|I|breathing, severe drowsiness/dizziness) may be increased if this||
8118|211|I|medication is taken with other products that may also cause||
8118|212|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
8118|213|I|if you are taking other products such as other opioid pain or||
8118|214|I|cough relievers (such as codeine, hydromorphone), alcohol,||
8118|215|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
8118|216|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
8118|217|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
8118|218|I|cetirizine, diphenhydramine).||
8118|219|I|   Check the labels on all your medicines (such as allergy or||
8118|220|I|cough-and-cold products) because they may contain ingredients||
8118|221|I|that cause drowsiness. Ask your pharmacist about using those||
8118|222|I|products safely.||
8118|223|I|   Other medications can affect the removal of||
8118|224|I|hydrocodone/homatropine from your body, which may affect how||
8118|225|I|hydrocodone/homatropine works. Examples include azole antifungals||
8118|226|I|(such as ketoconazole), macrolide antibiotics (such as||
8118|227|I|erythromycin), mifepristone, HIV medications (such as||
8118|228|I|tipranavir), rifamycins (such as rifabutin, rifampin), ritonavir,||
8118|229|I|certain drugs used to treat seizures (such as carbamazepine,||
8118|230|I|phenytoin), among others.||
8118|231|I|   This medication may interfere with certain lab tests (such as||
8118|232|I|amylase/lipase levels), possibly causing false test results. Make||
8118|233|I|sure lab personnel and all your doctors know you use this drug.||
8118|234|B|||
8118|235|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8118|236|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8118|237|O|poison control center right away. US residents can call||
8118|238|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8118|239|O|Symptoms of overdose may include: slow breathing, slow heartbeat,||
8118|240|O|cold/clammy skin, coma.||
8118|241|B|||
8118|242|N|NOTES:  Do not share this medication with others. Sharing it is||
8118|243|N|against the law.||
8118|244|N|   This medication has been prescribed for your current condition||
8118|245|N|only. Do not use it later for another condition unless told to do||
8118|246|N|so by your doctor. A different medication may be necessary in||
8118|247|N|those cases.||
8118|248|B|||
8118|249|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8118|250|D|remember. If it is near the time of the next dose, skip the||
8118|251|D|missed dose. Take your next dose at the regular time. Do not||
8118|252|D|double the dose to catch up.||
8118|253|B|||
8118|254|R|STORAGE:  Store at room temperature away from light and moisture.||
8118|255|R|Do not store in the bathroom. Keep all medications away from||
8118|256|R|children and pets.||
8118|257|R|   Do not flush medications down the toilet or pour them into a||
8118|258|R|drain unless instructed to do so. Properly discard this product||
8118|259|R|when it is expired or no longer needed. Consult your pharmacist||
8118|260|R|or local waste disposal company.||
8118|261|B|||
8118|262|A|Information last revised August 2025.||
8118|263|A|Copyright(c) 2025 First Databank, Inc.||
8118|264|B|||
8119|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8119|002|Z|does NOT have all possible information about this product. This||
8119|003|Z|information does not assure that this product is safe, effective,||
8119|004|Z|or appropriate for you. This information is not individual||
8119|005|Z|medical advice and does not substitute for the advice of your||
8119|006|Z|health care professional. Always ask your health care||
8119|007|Z|professional for complete information about this product and your||
8119|008|Z|specific health needs.||
8119|009|B|||
8119|010|T|ALBENDAZOLE - ORAL||
8119|011|F|(al-BEN-da-zole)||
8119|012|B|||
8119|013|C|COMMON BRAND NAME(S): Albenza||
8119|014|B|||
8119|015|U|USES:  This medication is used to treat certain tapeworm||
8119|016|U|infections (such as neurocysticercosis and hydatid disease).||
8119|017|B|||
8119|018|V|OTHER USES:  This section contains uses of this drug that are not||
8119|019|V|listed in the approved professional labeling for the drug but||
8119|020|V|that may be prescribed by your health care professional. Use this||
8119|021|V|drug for a condition that is listed in this section only if it||
8119|022|V|has been so prescribed by your health care professional.||
8119|023|V|   This drug may also be used for other types of worm infections.||
8119|024|B|||
8119|025|H|HOW TO USE:  Take this medication by mouth with meals as directed||
8119|026|H|by your doctor, usually 1 to 2 times daily. If you or your child||
8119|027|H|have trouble swallowing tablets, you may crush or chew your dose||
8119|028|H|and take it with water.||
8119|029|H|   For some conditions (such as hydatid disease), your doctor may||
8119|030|H|direct you to take this medication in a treatment cycle (for||
8119|031|H|example, twice daily with meals for 28 days then stopping the||
8119|032|H|medication for 2 weeks). Carefully follow your doctor's||
8119|033|H|instructions.||
8119|034|H|   The dosage is based on your weight, medical condition, and||
8119|035|H|response to treatment.||
8119|036|H|   Use this medication regularly to get the most benefit from it.||
8119|037|H|To help you remember, take it at the same time(s) each day. If||
8119|038|H|your doctor directs you to take this medication in a treatment||
8119|039|H|cycle, it may be helpful to mark your calendar with a reminder.||
8119|040|H|   Continue to take this medication until the full prescribed||
8119|041|H|amount is finished, even if symptoms disappear after a few days.||
8119|042|H|Stopping the medication too early may result in a return of the||
8119|043|H|infection.||
8119|044|H|   Other medications (such as corticosteroids, anti-seizure||
8119|045|H|medications) may also be prescribed for your current condition.||
8119|046|H|Take those medications exactly as directed by your doctor.||
8119|047|H|   Avoid eating grapefruit or drinking grapefruit juice while||
8119|048|H|using this medication unless your doctor or pharmacist says you||
8119|049|H|may do so safely. Grapefruit can increase the chance of side||
8119|050|H|effects with this medicine. Ask your doctor or pharmacist for||
8119|051|H|more details.||
8119|052|H|   Tell your doctor if your condition lasts or gets worse.||
8119|053|B|||
8119|054|S|SIDE EFFECTS:  Nausea, vomiting, abdominal pain, headache, or||
8119|055|S|temporary hair loss may occur. If any of these effects last or||
8119|056|S|get worse, tell your doctor or pharmacist promptly.||
8119|057|S|   Remember that this medication has been prescribed because your||
8119|058|S|doctor has judged that the benefit to you is greater than the||
8119|059|S|risk of side effects. Many people using this medication do not||
8119|060|S|have serious side effects.||
8119|061|S|   Tell your doctor right away if you have any serious side||
8119|062|S|effects, including: severe headache that doesn't go away, vision||
8119|063|S|changes, yellowing eyes/skin, severe stomach/abdominal pain, dark||
8119|064|S|urine, unusual tiredness, easy bruising/bleeding, signs of||
8119|065|S|infection (such as sore throat that doesn't go away, fever,||
8119|066|S|chills), signs of kidney problems (such as change in the amount||
8119|067|S|of urine), confusion, very stiff neck.||
8119|068|S|   Get medical help right away if you have any very serious side||
8119|069|S|effects, including: seizures.||
8119|070|S|   A very serious allergic reaction to this drug is rare.||
8119|071|S|However, get medical help right away if you notice any symptoms||
8119|072|S|of a serious allergic reaction, including: rash, itching/swelling||
8119|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8119|074|S|breathing.||
8119|075|S|   This is not a complete list of possible side effects. If you||
8119|076|S|notice other effects not listed above, contact your doctor or||
8119|077|S|pharmacist.||
8119|078|S|   In the US -||
8119|079|S|   Call your doctor for medical advice about side effects. You||
8119|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8119|081|S|www.fda.gov/medwatch.||
8119|082|S|   In Canada - Call your doctor for medical advice about side||
8119|083|S|effects. You may report side effects to Health Canada at||
8119|084|S|1-866-234-2345.||
8119|085|B|||
8119|086|P|PRECAUTIONS:  Before taking albendazole, tell your doctor or||
8119|087|P|pharmacist if you are allergic to it; or to other benzimidazole||
8119|088|P|anthelmintic drugs (such as mebendazole); or if you have any||
8119|089|P|other allergies. This product may contain inactive ingredients,||
8119|090|P|which can cause allergic reactions or other problems. Talk to||
8119|091|P|your pharmacist for more details.||
8119|092|P|   Before using this medication, tell your doctor or pharmacist||
8119|093|P|your medical history, especially of: liver disease, biliary tract||
8119|094|P|problems (such as blockage), blood/bone marrow disorders.||
8119|095|P|   This medication may cause liver problems. Because drinking||
8119|096|P|alcohol increases the risk of liver problems, limit alcoholic||
8119|097|P|beverages while using this medication. Check with your doctor or||
8119|098|P|pharmacist for more information.||
8119|099|P|   Before having surgery, tell your doctor or dentist about all||
8119|100|P|the products you use (including prescription drugs,||
8119|101|P|nonprescription drugs, and herbal products).||
8119|102|P|   Tell your doctor if you are pregnant or plan to become||
8119|103|P|pregnant. You should not become pregnant while using albendazole.||
8119|104|P|Albendazole may harm an unborn baby. Your doctor should order a||
8119|105|P|pregnancy test before you start this medication. Ask about||
8119|106|P|reliable forms of birth control while using this medication and||
8119|107|P|for 3 days after the last dose. If you become pregnant, talk to||
8119|108|P|your doctor right away about the risks and benefits of this||
8119|109|P|medication.||
8119|110|P|   This medication passes into breast milk. Consult your doctor||
8119|111|P|before breastfeeding.||
8119|112|B|||
8119|113|I|DRUG INTERACTIONS:  See also How to Use section.||
8119|114|I|   Drug interactions may change how your medications work or||
8119|115|I|increase your risk for serious side effects. This document does||
8119|116|I|not contain all possible drug interactions. Keep a list of all||
8119|117|I|the products you use (including prescription/nonprescription||
8119|118|I|drugs and herbal products) and share it with your doctor and||
8119|119|I|pharmacist. Do not start, stop, or change the dosage of any||
8119|120|I|medicines without your doctor's approval.||
8119|121|B|||
8119|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8119|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8119|124|O|poison control center right away. US residents can call||
8119|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8119|126|B|||
8119|127|N|NOTES:  Do not share this medication with others.||
8119|128|N|   This medication has been prescribed for your current condition||
8119|129|N|only. Do not use it later for another infection unless your||
8119|130|N|doctor tells you to.||
8119|131|N|   Lab and/or medical tests (such as liver function, complete||
8119|132|N|blood counts) should be done before you start taking this||
8119|133|N|medication and while you are taking it. Keep all medical and lab||
8119|134|N|appointments. Consult your doctor for more details.||
8119|135|B|||
8119|136|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8119|137|D|remember. If it is near the time of the next dose, skip the||
8119|138|D|missed dose. Take your next dose at the regular time. Do not||
8119|139|D|double the dose to catch up.||
8119|140|B|||
8119|141|R|STORAGE:  Store at room temperature away from light and moisture.||
8119|142|R|Do not store in the bathroom. Keep all medications away from||
8119|143|R|children and pets.||
8119|144|R|   Do not flush medications down the toilet or pour them into a||
8119|145|R|drain unless instructed to do so. Properly discard this product||
8119|146|R|when it is expired or no longer needed. Consult your pharmacist||
8119|147|R|or local waste disposal company.||
8119|148|B|||
8119|149|A|Information last revised January 2025.||
8119|150|A|Copyright(c) 2025 First Databank, Inc.||
8119|151|B|||
8120|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8120|002|Z|does NOT have all possible information about this product. This||
8120|003|Z|information does not assure that this product is safe, effective,||
8120|004|Z|or appropriate for you. This information is not individual||
8120|005|Z|medical advice and does not substitute for the advice of your||
8120|006|Z|health care professional. Always ask your health care||
8120|007|Z|professional for complete information about this product and your||
8120|008|Z|specific health needs.||
8120|009|B|||
8120|010|T|PROGESTERONE - INTRAMUSCULAR||
8120|011|F|(pro-JESS-ter-own)||
8120|012|B|||
8120|013|U|USES:  Progesterone is a type of hormone (progestin). This||
8120|014|U|medication is similar to the progesterone that your body||
8120|015|U|naturally makes. It is given to replace the hormone when your||
8120|016|U|body is not making enough of it. In women who are not pregnant||
8120|017|U|and have not gone through menopause, this medication is used to||
8120|018|U|restore normal menstrual periods that have stopped for several||
8120|019|U|months (amenorrhea). It is also used to treat abnormal bleeding||
8120|020|U|from the uterus that is due to low hormone levels and not other||
8120|021|U|causes (such as fibroids, cancer of the uterus).||
8120|022|U|   Progesterone must not be used to test for pregnancy.||
8120|023|B|||
8120|024|V|OTHER USES:  This section contains uses of this drug that are not||
8120|025|V|listed in the approved professional labeling for the drug but||
8120|026|V|that may be prescribed by your health care professional. Use this||
8120|027|V|drug for a condition that is listed in this section only if it||
8120|028|V|has been so prescribed by your health care professional.||
8120|029|V|   This drug may also be used to maintain pregnancy.||
8120|030|B|||
8120|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8120|032|H|from your pharmacist before you start using progesterone and each||
8120|033|H|time you get a refill. If you have any questions, ask your doctor||
8120|034|H|or pharmacist.||
8120|035|H|   This medication is given by injection into a muscle as||
8120|036|H|directed by your doctor, usually once daily. This medication is||
8120|037|H|usually given for 6 to 8 days. The dosage is based on your||
8120|038|H|medical condition and response to treatment.||
8120|039|H|   If you are giving this medication to yourself at home, learn||
8120|040|H|all preparation and usage instructions from your health care||
8120|041|H|professional. Before using, check this product for particles or||
8120|042|H|discoloration. If either is present, do not use the liquid. Learn||
8120|043|H|how to store and discard medical supplies safely.||
8120|044|H|   Before injecting each dose, clean the skin you are going to||
8120|045|H|inject into (the injection site) with rubbing alcohol. Change the||
8120|046|H|injection site daily to avoid problem areas in the muscle.||
8120|047|H|   Use this medication regularly to get the most benefit from it.||
8120|048|H|To help you remember, use it at the same time each day.||
8120|049|H|   Tell your doctor if your condition lasts or gets worse.||
8120|050|B|||
8120|051|S|SIDE EFFECTS:  Pain/swelling at injection site, breast||
8120|052|S|tenderness, headache, weight gain/loss, acne, nausea, increased||
8120|053|S|body/facial hair, loss of scalp hair, drowsiness, or dizziness||
8120|054|S|may occur. If any of these effects last or get worse, tell your||
8120|055|S|doctor or pharmacist promptly.||
8120|056|S|   Remember that this medication has been prescribed because your||
8120|057|S|doctor has judged that the benefit to you is greater than the||
8120|058|S|risk of side effects. Many people using this medication do not||
8120|059|S|have serious side effects.||
8120|060|S|   Tell your doctor right away if you have any serious side||
8120|061|S|effects, including: nausea/vomiting that doesn't stop, unusual||
8120|062|S|vaginal bleeding/discharge (such as breakthrough bleeding,||
8120|063|S|spotting), stopped menstrual periods (amenorrhea), breast lumps,||
8120|064|S|swelling of the ankles/feet, mental/mood changes (such as||
8120|065|S|depression, nervousness), dark patches on the skin/face,||
8120|066|S|frequent/painful urination, dark urine, yellowing eyes/skin,||
8120|067|S|stomach/abdominal pain.||
8120|068|S|   This medication, especially if used along with an estrogen||
8120|069|S|product, may rarely cause very serious (possibly fatal) problems||
8120|070|S|from blood clots (such as heart attack, stroke, blood clots in||
8120|071|S|the lungs, legs, or eyes). Get medical help right away if you||
8120|072|S|have: chest/jaw/left arm pain, weakness on one side of the body,||
8120|073|S|trouble speaking, sudden vision changes, confusion,||
8120|074|S|pain/swelling/warmth in the groin/calf, shortness of breath/rapid||
8120|075|S|breathing, sudden/severe headaches, sudden dizziness/fainting,||
8120|076|S|unusual sweating.||
8120|077|S|   A very serious allergic reaction to this drug is rare.||
8120|078|S|However, get medical help right away if you notice any symptoms||
8120|079|S|of a serious allergic reaction, including: rash, itching/swelling||
8120|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8120|081|S|breathing, fever.||
8120|082|S|   This is not a complete list of possible side effects. If you||
8120|083|S|notice other effects not listed above, contact your doctor or||
8120|084|S|pharmacist.||
8120|085|S|   In the US -||
8120|086|S|   Call your doctor for medical advice about side effects. You||
8120|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8120|088|S|www.fda.gov/medwatch.||
8120|089|S|   In Canada - Call your doctor for medical advice about side||
8120|090|S|effects. You may report side effects to Health Canada at||
8120|091|S|1-866-234-2345.||
8120|092|B|||
8120|093|P|PRECAUTIONS:  Before using progesterone, tell your doctor or||
8120|094|P|pharmacist if you are allergic to it; or if you have any other||
8120|095|P|allergies. This product may contain inactive ingredients (such as||
8120|096|P|sesame oil), which can cause allergic reactions or other||
8120|097|P|problems. Talk to your pharmacist for more details.||
8120|098|P|   Before using this medication, tell your doctor or pharmacist||
8120|099|P|your medical history, especially of: blood clots, history of||
8120|100|P|bleeding in the brain, liver disease, cancer (especially of the||
8120|101|P|breast or other female organs), vaginal bleeding of unknown||
8120|102|P|cause, a loss of pregnancy with some tissue remaining in the||
8120|103|P|uterus ("missed abortion"), migraine headaches, seizures, asthma,||
8120|104|P|heart disease (such as coronary artery disease, heart failure),||
8120|105|P|kidney disease, depression, diabetes, high blood levels of||
8120|106|P|cholesterol/triglycerides.||
8120|107|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8120|108|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8120|109|P|machinery, or do anything that needs alertness until you can do||
8120|110|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8120|111|P|are using marijuana (cannabis).||
8120|112|P|   Before having surgery, tell your doctor or dentist about all||
8120|113|P|the products you use (including prescription drugs,||
8120|114|P|nonprescription drugs, and herbal products).||
8120|115|P|   If you have diabetes, this product may affect your blood||
8120|116|P|sugar. Check your blood sugar regularly as directed and share the||
8120|117|P|results with your doctor. Tell your doctor right away if you have||
8120|118|P|symptoms of high blood sugar, such as increased thirst/urination.||
8120|119|P|Your doctor may need to adjust your diabetes medication, exercise||
8120|120|P|program, or diet.||
8120|121|P|   This medication may cause blotchy, dark areas on your face and||
8120|122|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
8120|123|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
8120|124|P|wear protective clothing when outdoors.||
8120|125|P|   This medication may be used during pregnancy only as directed||
8120|126|P|by your doctor. Discuss the risks and benefits with your doctor.||
8120|127|P|   This drug passes into breast milk. Consult your doctor before||
8120|128|P|breastfeeding.||
8120|129|B|||
8120|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8120|131|I|medications work or increase your risk for serious side effects.||
8120|132|I|This document does not contain all possible drug interactions.||
8120|133|I|Keep a list of all the products you use (including||
8120|134|I|prescription/nonprescription drugs and herbal products) and share||
8120|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
8120|136|I|the dosage of any medicines without your doctor's approval.||
8120|137|I|   This medication may interfere with certain lab tests, possibly||
8120|138|I|causing false test results. Make sure lab personnel and all your||
8120|139|I|doctors know you use this drug.||
8120|140|B|||
8120|141|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8120|142|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8120|143|O|poison control center right away. US residents can call||
8120|144|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8120|145|B|||
8120|146|N|NOTES:  Do not share this medication with others.||
8120|147|N|   Regular complete physical exams which include lab and/or||
8120|148|N|medical tests (such as blood pressure, breast exam/mammogram,||
8120|149|N|pelvic exam, Pap smear) should be done while you are using this||
8120|150|N|medication. Follow your doctor's instructions for examining your||
8120|151|N|breasts, and report any lumps right away. Keep all medical and||
8120|152|N|lab appointments. Consult your doctor for more details.||
8120|153|B|||
8120|154|D|MISSED DOSE:  It is important to get each dose of this medication||
8120|155|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8120|156|D|right away for a new dosing schedule. Do not double the dose to||
8120|157|D|catch up.||
8120|158|B|||
8120|159|R|STORAGE:  Consult the product instructions and your pharmacist||
8120|160|R|for storage details. Keep all medications away from children and||
8120|161|R|pets.||
8120|162|R|   Do not flush medications down the toilet or pour them into a||
8120|163|R|drain unless instructed to do so. Properly discard this product||
8120|164|R|when it is expired or no longer needed. Consult your pharmacist||
8120|165|R|or local waste disposal company.||
8120|166|B|||
8120|167|A|Information last revised November 2025.||
8120|168|A|Copyright(c) 2025 First Databank, Inc.||
8120|169|B|||
8122|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8122|002|Z|does NOT have all possible information about this product. This||
8122|003|Z|information does not assure that this product is safe, effective,||
8122|004|Z|or appropriate for you. This information is not individual||
8122|005|Z|medical advice and does not substitute for the advice of your||
8122|006|Z|health care professional. Always ask your health care||
8122|007|Z|professional for complete information about this product and your||
8122|008|Z|specific health needs.||
8122|009|B|||
8122|010|T|METHIMAZOLE - ORAL||
8122|011|F|(meh-THIM-uh-zole)||
8122|012|B|||
8122|013|C|COMMON BRAND NAME(S): Tapazole||
8122|014|B|||
8122|015|U|USES:  Methimazole is used to treat overactive thyroid||
8122|016|U|(hyperthyroidism). It works by stopping the thyroid gland from||
8122|017|U|making too much thyroid hormone.||
8122|018|B|||
8122|019|H|HOW TO USE:  Take this medication by mouth with or without food||
8122|020|H|as directed by your doctor, usually 1 to 3 times a day.||
8122|021|H|   The dosage is based on your medical condition and response to||
8122|022|H|treatment. Children's dosage is also based on weight.||
8122|023|H|   Take this medication exactly as directed. Do not increase your||
8122|024|H|dose or take it more often than prescribed. Your condition will||
8122|025|H|not improve faster, and your risk of side effects will increase.||
8122|026|H|   Use this medication regularly to get the most benefit from it.||
8122|027|H|To help you remember, take it at the same time(s) each day. Do||
8122|028|H|not stop taking this medication without consulting your doctor.||
8122|029|H|   Tell your doctor if your condition does not get better or if||
8122|030|H|it gets worse.||
8122|031|B|||
8122|032|S|SIDE EFFECTS:  Stomach upset, nausea, vomiting, or mild||
8122|033|S|rash/itching may occur. If any of these effects last or get||
8122|034|S|worse, tell your doctor or pharmacist promptly.||
8122|035|S|   Remember that this medication has been prescribed because your||
8122|036|S|doctor has judged that the benefit to you is greater than the||
8122|037|S|risk of side effects. Many people using this medication do not||
8122|038|S|have serious side effects.||
8122|039|S|   Tell your doctor right away if you have any serious side||
8122|040|S|effects, including: joint/muscle pain, numb/tingling skin,||
8122|041|S|shortness of breath, coughing up blood, signs of liver problems||
8122|042|S|(such as nausea/vomiting that doesn't stop, yellowing eyes/skin,||
8122|043|S|dark urine, severe stomach/abdominal pain), signs of kidney||
8122|044|S|problems (such as change in the amount of urine, bloody urine).||
8122|045|S|   This medication may rarely cause very serious blood disorders||
8122|046|S|(such as a low number of red cells, white cells, and platelets),||
8122|047|S|especially during the first few months of treatment. Tell your||
8122|048|S|doctor right away if you develop any of the following symptoms:||
8122|049|S|signs of infection (such as sore throat that doesn't go away,||
8122|050|S|fever, chills), easy bruising/bleeding, unusual tiredness.||
8122|051|S|   A very serious allergic reaction to this drug is rare.||
8122|052|S|However, get medical help right away if you notice any symptoms||
8122|053|S|of a serious allergic reaction, including: rash, itching/swelling||
8122|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8122|055|S|breathing.||
8122|056|S|   This is not a complete list of possible side effects. If you||
8122|057|S|notice other effects not listed above, contact your doctor or||
8122|058|S|pharmacist.||
8122|059|S|   In the US -||
8122|060|S|   Call your doctor for medical advice about side effects. You||
8122|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8122|062|S|www.fda.gov/medwatch.||
8122|063|S|   In Canada - Call your doctor for medical advice about side||
8122|064|S|effects. You may report side effects to Health Canada at||
8122|065|S|1-866-234-2345.||
8122|066|B|||
8122|067|P|PRECAUTIONS:  Before taking methimazole, tell your doctor or||
8122|068|P|pharmacist if you are allergic to it; or if you have any other||
8122|069|P|allergies. This product may contain inactive ingredients, which||
8122|070|P|can cause allergic reactions or other problems. Talk to your||
8122|071|P|pharmacist for more details.||
8122|072|P|   Before using this medication, tell your doctor or pharmacist||
8122|073|P|your medical history, especially of: blood disorders (such as||
8122|074|P|agranulocytosis, thrombocytopenia), liver disease, pancreatitis.||
8122|075|P|   Before having surgery, tell your doctor or dentist about all||
8122|076|P|the products you use (including prescription drugs,||
8122|077|P|nonprescription drugs, and herbal products).||
8122|078|P|   This medication is not recommended for use during the first 3||
8122|079|P|months of pregnancy. Your doctor may direct you to use another||
8122|080|P|medication during that time. It should be used only when clearly||
8122|081|P|needed during the last 6 months of pregnancy. Discuss the risks||
8122|082|P|and benefits with your doctor. If you are planning pregnancy,||
8122|083|P|become pregnant, or think you may be pregnant, contact your||
8122|084|P|doctor right away.||
8122|085|P|   This medication passes into breast milk. Consult your doctor||
8122|086|P|before breastfeeding.||
8122|087|B|||
8122|088|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8122|089|I|medications work or increase your risk for serious side effects.||
8122|090|I|This document does not contain all possible drug interactions.||
8122|091|I|Keep a list of all the products you use (including||
8122|092|I|prescription/nonprescription drugs and herbal products) and share||
8122|093|I|it with your doctor and pharmacist. Do not start, stop, or change||
8122|094|I|the dosage of any medicines without your doctor's approval.||
8122|095|I|   Some products that may interact with this drug include: "blood||
8122|096|I|thinners" (such as warfarin), digoxin.||
8122|097|B|||
8122|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8122|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8122|100|O|poison control center right away. US residents can call||
8122|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8122|102|B|||
8122|103|N|NOTES:  Do not share this medication with others.||
8122|104|N|   Lab and/or medical tests (such as complete blood counts,||
8122|105|N|liver/thyroid function, prothrombin time) should be done while||
8122|106|N|you are taking this medication. Keep all medical and lab||
8122|107|N|appointments. Consult your doctor for more details.||
8122|108|B|||
8122|109|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8122|110|D|remember. If it is near the time of the next dose, skip the||
8122|111|D|missed dose. Take your next dose at the regular time. Do not||
8122|112|D|double the dose to catch up.||
8122|113|B|||
8122|114|R|STORAGE:  Store at room temperature away from light and moisture.||
8122|115|R|Storage temperature ranges differ according to different||
8122|116|R|manufacturers, so consult your pharmacist for more information.||
8122|117|R|Do not store in the bathroom. Keep all medications away from||
8122|118|R|children and pets.||
8122|119|R|   Do not flush medications down the toilet or pour them into a||
8122|120|R|drain unless instructed to do so. Properly discard this product||
8122|121|R|when it is expired or no longer needed. Consult your pharmacist||
8122|122|R|or local waste disposal company.||
8122|123|B|||
8122|124|A|Information last revised May 2025.||
8122|125|A|Copyright(c) 2025 First Databank, Inc.||
8122|126|B|||
8126|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8126|002|Z|does NOT have all possible information about this product. This||
8126|003|Z|information does not assure that this product is safe, effective,||
8126|004|Z|or appropriate for you. This information is not individual||
8126|005|Z|medical advice and does not substitute for the advice of your||
8126|006|Z|health care professional. Always ask your health care||
8126|007|Z|professional for complete information about this product and your||
8126|008|Z|specific health needs.||
8126|009|B|||
8126|010|T|OMEGA-3 FATTY ACIDS - ORAL||
8126|011|B|||
8126|012|U|USES:  Omega-3 fatty acids are thought to help reduce the risk of||
8126|013|U|heart disease. They have been used along with diet and exercise||
8126|014|U|to help lower levels of a certain blood fat (triglyceride) and to||
8126|015|U|raise levels of "good" cholesterol (HDL).||
8126|016|U|   Some supplement products have been found to contain possibly||
8126|017|U|harmful impurities/additives. Check with your pharmacist for more||
8126|018|U|details about the brand you use.||
8126|019|U|   The US Food and Drug Administration has not reviewed this||
8126|020|U|product for safety or effectiveness. Consult your doctor or||
8126|021|U|pharmacist for more details.||
8126|022|B|||
8126|023|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
8126|024|H|directions on the package label. If you have any questions, ask||
8126|025|H|your doctor or pharmacist.||
8126|026|H|   If you are using the enteric-coated capsules, swallow the||
8126|027|H|capsules whole. If you are using the chewable form of this||
8126|028|H|product, chew thoroughly before swallowing.||
8126|029|H|   If you are using the liquid form of this medication, carefully||
8126|030|H|measure the dose using a special measuring device/spoon. Do not||
8126|031|H|use a household spoon because you may not get the correct dose.||
8126|032|H|Some brands of this medication should be shaken well before each||
8126|033|H|use.||
8126|034|H|   If your condition lasts or gets worse, or if you think you may||
8126|035|H|have a serious medical problem, get medical help right away.||
8126|036|B|||
8126|037|S|SIDE EFFECTS:  Fishy aftertaste (if your product is made from||
8126|038|S|fish oil), nausea, bloating, or burping may occur. If any of||
8126|039|S|these effects last or get worse, tell your doctor or pharmacist||
8126|040|S|promptly.||
8126|041|S|   If your doctor has directed you to use this product, remember||
8126|042|S|that your doctor has judged that the benefit to you is greater||
8126|043|S|than the risk of side effects. Many people using this medication||
8126|044|S|do not have serious side effects.||
8126|045|S|   Tell your doctor right away if you have any serious side||
8126|046|S|effects, including: easy bleeding/bruising.||
8126|047|S|   A very serious allergic reaction to this drug is rare.||
8126|048|S|However, get medical help right away if you notice any symptoms||
8126|049|S|of a serious allergic reaction, including: rash, itching/swelling||
8126|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8126|051|S|breathing.||
8126|052|S|   This is not a complete list of possible side effects. If you||
8126|053|S|notice other effects not listed above, contact your doctor or||
8126|054|S|pharmacist.||
8126|055|S|   In the US -||
8126|056|S|   Call your doctor for medical advice about side effects. You||
8126|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8126|058|S|www.fda.gov/medwatch.||
8126|059|S|   In Canada - Call your doctor for medical advice about side||
8126|060|S|effects. You may report side effects to Health Canada at||
8126|061|S|1-866-234-2345.||
8126|062|B|||
8126|063|P|PRECAUTIONS:  Before taking omega-3 fatty acids, tell your doctor||
8126|064|P|or pharmacist if you are allergic to them; or to fish; or if you||
8126|065|P|have any other allergies. This product may contain inactive||
8126|066|P|ingredients (such as peanut/soy), which can cause allergic||
8126|067|P|reactions or other problems. Talk to your pharmacist for more||
8126|068|P|details.||
8126|069|P|   If you have any health problems, consult your doctor or||
8126|070|P|pharmacist before using this product.||
8126|071|P|   Before having surgery, tell your doctor or dentist about all||
8126|072|P|the products you use (including prescription drugs,||
8126|073|P|nonprescription drugs, and herbal products).||
8126|074|P|   During pregnancy, this medication should be used only when||
8126|075|P|clearly needed. Discuss the risks and benefits with your doctor.||
8126|076|P|   It is unknown if this product passes into breast milk. Consult||
8126|077|P|your doctor before breastfeeding.||
8126|078|B|||
8126|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8126|080|I|medications work or increase your risk for serious side effects.||
8126|081|I|This document does not contain all possible drug interactions.||
8126|082|I|Keep a list of all the products you use (including||
8126|083|I|prescription/nonprescription drugs and herbal products) and share||
8126|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
8126|085|I|the dosage of any medicines without your doctor's approval.||
8126|086|B|||
8126|087|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8126|088|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8126|089|O|poison control center right away. US residents can call||
8126|090|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8126|091|B|||
8126|092|N|NOTES:  Lab and/or medical tests (such as cholesterol, liver||
8126|093|N|function) may be done while you are taking this medication. Keep||
8126|094|N|all medical and lab appointments. Consult your doctor for more||
8126|095|N|details.||
8126|096|B|||
8126|097|D|MISSED DOSE:  If you are taking this product on a regular||
8126|098|D|schedule and miss a dose, take it as soon as you remember. If it||
8126|099|D|is near the time of the next dose, skip the missed dose. Take||
8126|100|D|your next dose at the regular time. Do not double the dose to||
8126|101|D|catch up.||
8126|102|B|||
8126|103|R|STORAGE:  Refer to storage information printed on the package. If||
8126|104|R|you have any questions about storage, ask your pharmacist.||
8126|105|R|Protect from light and moisture. Do not store in the bathroom. Do||
8126|106|R|not freeze. Keep all drug products away from children and pets.||
8126|107|R|   Do not flush medications down the toilet or pour them into a||
8126|108|R|drain unless instructed to do so. Properly discard this product||
8126|109|R|when it is expired or no longer needed. Consult your pharmacist||
8126|110|R|or local waste disposal company.||
8126|111|B|||
8126|112|A|Information last revised August 2024.||
8126|113|A|Copyright(c) 2025 First Databank, Inc.||
8126|114|B|||
8128|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8128|002|Z|does NOT have all possible information about this product. This||
8128|003|Z|information does not assure that this product is safe, effective,||
8128|004|Z|or appropriate for you. This information is not individual||
8128|005|Z|medical advice and does not substitute for the advice of your||
8128|006|Z|health care professional. Always ask your health care||
8128|007|Z|professional for complete information about this product and your||
8128|008|Z|specific health needs.||
8128|009|B|||
8128|010|T|CHLOROQUINE - ORAL||
8128|011|F|(KLOR-oh-kwin)||
8128|012|B|||
8128|013|C|COMMON BRAND NAME(S): Aralen||
8128|014|B|||
8128|015|U|USES:  Chloroquine is used to prevent or treat malaria caused by||
8128|016|U|mosquito bites. Chloroquine belongs to a class of drugs known as||
8128|017|U|antimalarials.||
8128|018|U|   The United States Centers for Disease Control provide updated||
8128|019|U|guidelines and travel recommendations for the prevention and||
8128|020|U|treatment of malaria in different parts of the world. Discuss the||
8128|021|U|most recent information with your doctor before traveling to||
8128|022|U|areas where malaria occurs.||
8128|023|U|   Chloroquine is also used to treat infection caused by a||
8128|024|U|different type of parasite (ameba).||
8128|025|U|   Chloroquine is not recommended for coronavirus infection, also||
8128|026|U|known as COVID-19, unless you are enrolled in a study. Talk to||
8128|027|U|your doctor about the risks and benefits.||
8128|028|B|||
8128|029|V|OTHER USES:  This section contains uses of this drug that are not||
8128|030|V|listed in the approved professional labeling for the drug but||
8128|031|V|that may be prescribed by your health care professional. Use this||
8128|032|V|drug for a condition that is listed in this section only if it||
8128|033|V|has been so prescribed by your health care professional.||
8128|034|V|   This drug may also be used for certain immune system diseases||
8128|035|V|(such as lupus).||
8128|036|B|||
8128|037|H|HOW TO USE:  Take this medication by mouth, usually with food to||
8128|038|H|prevent stomach upset, exactly as directed by your doctor. The||
8128|039|H|dosage and length of treatment are based on your medical||
8128|040|H|condition and response to treatment. Children's dosage is also||
8128|041|H|based on weight.||
8128|042|H|   To prevent malaria, take chloroquine as directed by your||
8128|043|H|doctor, usually once a week on the same day each week. To help||
8128|044|H|you remember, mark your calendar with a reminder. This drug is||
8128|045|H|usually started 1 to 2 weeks before entering the malarious area.||
8128|046|H|Continue to take it weekly while in the area and for 4 to 8 weeks||
8128|047|H|after leaving the area, or as directed by your doctor.||
8128|048|H|   To treat malaria or an ameba infection, follow your doctor's||
8128|049|H|instructions.||
8128|050|H|   If you are also taking a certain drug for diarrhea (kaolin) or||
8128|051|H|taking antacids (such as magnesium/aluminum hydroxide), take||
8128|052|H|chloroquine at least 4 hours before or after these products.||
8128|053|H|These products may bind with chloroquine, preventing your body||
8128|054|H|from fully absorbing it.||
8128|055|H|   Use this medication regularly in order to get the most benefit||
8128|056|H|from it. Take this medication exactly as prescribed. Do not stop||
8128|057|H|taking it without talking with your doctor. It is important to||
8128|058|H|keep taking this for the length of time prescribed. Stopping||
8128|059|H|prevention or treatment too soon may lead to infection or a||
8128|060|H|return of the infection.||
8128|061|H|   Tell your doctor if your condition lasts or gets worse.||
8128|062|H|Chloroquine may not prevent malaria in all cases. If you||
8128|063|H|experience fever or other symptoms of illness, get medical help||
8128|064|H|right away (especially while in the malarious area and for 2||
8128|065|H|months after returning from the area). You may need a different||
8128|066|H|medication. Avoid exposure to mosquitoes. (See also Notes||
8128|067|H|section.)||
8128|068|B|||
8128|069|S|SIDE EFFECTS:  Nausea, vomiting, abdominal cramps, headache, and||
8128|070|S|diarrhea may occur. If any of these effects last or get worse,||
8128|071|S|tell your doctor or pharmacist promptly.||
8128|072|S|   Remember that this medication has been prescribed because your||
8128|073|S|doctor has judged that the benefit to you is greater than the||
8128|074|S|risk of side effects. Many people using this medication do not||
8128|075|S|have serious side effects.||
8128|076|S|   Tell your doctor right away if you have any serious side||
8128|077|S|effects, including: slow heartbeat, symptoms of heart failure||
8128|078|S|(such as shortness of breath, swelling ankles/feet, unusual||
8128|079|S|tiredness, unusual/sudden weight gain), mental/mood changes (such||
8128|080|S|as anxiety, depression, rare thoughts of suicide,||
8128|081|S|hallucinations), hearing changes (such as ringing in the ears,||
8128|082|S|hearing loss), easy bruising/bleeding, signs of liver disease||
8128|083|S|(such as severe stomach/abdominal pain, yellowing eyes/skin, dark||
8128|084|S|urine), signs of kidney problems (such as change in the amount of||
8128|085|S|urine), muscle weakness, unwanted/uncontrolled movements||
8128|086|S|(including tongue/face twitching), hair loss, hair/skin color||
8128|087|S|changes.||
8128|088|S|   This medication may cause low blood sugar (hypoglycemia). Tell||
8128|089|S|your doctor right away if you develop symptoms of low blood||
8128|090|S|sugar, such as sudden sweating, shaking, hunger, blurred vision,||
8128|091|S|dizziness, or tingling hands/feet. If you have diabetes, be sure||
8128|092|S|to check your blood sugars regularly. Your doctor may need to||
8128|093|S|adjust your diabetes medication.||
8128|094|S|   Get medical help right away if you have any very serious side||
8128|095|S|effects, including: severe dizziness, fainting, fast/irregular||
8128|096|S|heartbeat, seizures.||
8128|097|S|   This medication may cause serious eye/vision problems. The||
8128|098|S|risk for these side effects is increased with long-term use of||
8128|099|S|this medication and with taking this medication in high doses.||
8128|100|S|Get medical help right away if you have any symptoms of serious||
8128|101|S|eye problems, including: sensitivity to light, vision changes||
8128|102|S|(such as light flashes/streaks, blurred vision, difficulty||
8128|103|S|reading, missing areas of vision).||
8128|104|S|   A very serious allergic reaction to this drug is rare.||
8128|105|S|However, get medical help right away if you notice any symptoms||
8128|106|S|of a serious allergic reaction, including: fever, swollen lymph||
8128|107|S|nodes, rash, itching/swelling (especially of the||
8128|108|S|face/tongue/throat), severe dizziness, trouble breathing.||
8128|109|S|   This is not a complete list of possible side effects. If you||
8128|110|S|notice other effects not listed above, contact your doctor or||
8128|111|S|pharmacist.||
8128|112|S|   In the US -||
8128|113|S|   Call your doctor for medical advice about side effects. You||
8128|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8128|115|S|www.fda.gov/medwatch.||
8128|116|S|   In Canada - Call your doctor for medical advice about side||
8128|117|S|effects. You may report side effects to Health Canada at||
8128|118|S|1-866-234-2345.||
8128|119|B|||
8128|120|P|PRECAUTIONS:  Before taking chloroquine, tell your doctor or||
8128|121|P|pharmacist if you are allergic to it; or to hydroxychloroquine;||
8128|122|P|or if you have any other allergies. This product may contain||
8128|123|P|inactive ingredients, which can cause allergic reactions or other||
8128|124|P|problems. Talk to your pharmacist for more details.||
8128|125|P|   Before using this medication, tell your doctor or pharmacist||
8128|126|P|your medical history, especially of: a certain enzyme problem||
8128|127|P|(glucose-6-phosphate dehydrogenase deficiency-G6PD), vision/eye||
8128|128|P|problems, hearing problems, kidney disease, liver disease,||
8128|129|P|regular alcohol use/abuse, skin problems (such as psoriasis), a||
8128|130|P|certain blood disorder (porphyria), seizures.||
8128|131|P|   If you have diabetes, this product may affect your blood||
8128|132|P|sugar. Check your blood sugar regularly as directed and share the||
8128|133|P|results with your doctor. Tell your doctor right away if you have||
8128|134|P|symptoms of low blood sugar (see Side Effects section). Your||
8128|135|P|doctor may need to adjust your diabetes medication, exercise||
8128|136|P|program, or diet.||
8128|137|P|   This medication may make you more sensitive to the sun. Limit||
8128|138|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8128|139|P|sunscreen and wear protective clothing when outdoors. Tell your||
8128|140|P|doctor right away if you get sunburned or have skin||
8128|141|P|blisters/redness.||
8128|142|P|   Before having surgery, tell your doctor or dentist about all||
8128|143|P|the products you use (including prescription drugs,||
8128|144|P|nonprescription drugs, and herbal products).||
8128|145|P|   Chloroquine may cause a condition that affects the heart||
8128|146|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8128|147|P|serious (rarely fatal) fast/irregular heartbeat and other||
8128|148|P|symptoms (such as severe dizziness, fainting) that need medical||
8128|149|P|attention right away.||
8128|150|P|   The risk of QT prolongation may be increased if you have||
8128|151|P|certain medical conditions or are taking other drugs that may||
8128|152|P|cause QT prolongation. Before using chloroquine, tell your doctor||
8128|153|P|or pharmacist of all the drugs you take and if you have any of||
8128|154|P|the following conditions: certain heart problems (heart failure,||
8128|155|P|slow heartbeat, QT prolongation in the EKG), family history of||
8128|156|P|certain heart problems (QT prolongation in the EKG, sudden||
8128|157|P|cardiac death).||
8128|158|P|   Low levels of potassium or magnesium in the blood may also||
8128|159|P|increase your risk of QT prolongation. This risk may increase if||
8128|160|P|you use certain drugs (such as diuretics/"water pills") or if you||
8128|161|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8128|162|P|Talk to your doctor about using chloroquine safely.||
8128|163|P|   Older adults may be more sensitive to the side effects of this||
8128|164|P|drug, especially QT prolongation (see above).||
8128|165|P|   During pregnancy, this medication should be used only when||
8128|166|P|clearly needed. Discuss the risks and benefits with your doctor.||
8128|167|P|   This drug passes into breast milk. Consult your doctor before||
8128|168|P|breastfeeding.||
8128|169|B|||
8128|170|I|DRUG INTERACTIONS:  See also How to Use section.||
8128|171|I|   Drug interactions may change how your medications work or||
8128|172|I|increase your risk for serious side effects. This document does||
8128|173|I|not contain all possible drug interactions. Keep a list of all||
8128|174|I|the products you use (including prescription/nonprescription||
8128|175|I|drugs and herbal products) and share it with your doctor and||
8128|176|I|pharmacist. Do not start, stop, or change the dosage of any||
8128|177|I|medicines without your doctor's approval.||
8128|178|I|   Some products that may interact with this drug are:||
8128|179|I|mefloquine, penicillamine, remdesivir.||
8128|180|I|   Many drugs besides chloroquine may affect the heart rhythm (QT||
8128|181|I|prolongation). Some examples are amiodarone, azithromycin,||
8128|182|I|disopyramide, dronedarone, pimozide, quinidine, among others.||
8128|183|I|   Certain vaccines (rabies vaccine, cholera vaccine) may not||
8128|184|I|work as well if given while you are taking chloroquine. Ask your||
8128|185|I|doctor for more details.||
8128|186|B|||
8128|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8128|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8128|189|O|poison control center right away. US residents can call||
8128|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8128|191|O|Symptoms of overdose may include: fast/irregular heartbeat,||
8128|192|O|fainting, slow/shallow breathing, unwanted/uncontrolled movements||
8128|193|O|(including tongue/face twitching), seizures.||
8128|194|B|||
8128|195|N|NOTES:  Do not share this medication with others.||
8128|196|N|   Lab and/or medical tests (such as eye exams, reflex tests,||
8128|197|N|liver/kidney function, EKG, complete blood counts) should be done||
8128|198|N|if you are taking chloroquine for a long time. Keep all medical||
8128|199|N|and lab appointments. Consult your doctor for more details.||
8128|200|N|   When traveling in an area at risk for malaria, use protective||
8128|201|N|clothing, insect repellent, and bed nets. Remain indoors or in||
8128|202|N|well-screened areas when possible. If you are taking this||
8128|203|N|medication to prevent or treat malaria, use it for your current||
8128|204|N|travel or condition only. Do not use it later to prevent or treat||
8128|205|N|another infection unless your doctor tells you to.||
8128|206|B|||
8128|207|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8128|208|D|remember. If it is near the time of the next dose, skip the||
8128|209|D|missed dose. Take your next dose at the regular time. Do not||
8128|210|D|double the dose to catch up.||
8128|211|B|||
8128|212|R|STORAGE:  Store at room temperature away from light and moisture.||
8128|213|R|Do not store in the bathroom. Keep all medications away from||
8128|214|R|children and pets.||
8128|215|R|   Do not flush medications down the toilet or pour them into a||
8128|216|R|drain unless instructed to do so. Properly discard this product||
8128|217|R|when it is expired or no longer needed. Consult your pharmacist||
8128|218|R|or local waste disposal company.||
8128|219|B|||
8128|220|A|Information last revised October 2024.||
8128|221|A|Copyright(c) 2025 First Databank, Inc.||
8128|222|B|||
8130|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8130|002|Z|does NOT have all possible information about this product. This||
8130|003|Z|information does not assure that this product is safe, effective,||
8130|004|Z|or appropriate for you. This information is not individual||
8130|005|Z|medical advice and does not substitute for the advice of your||
8130|006|Z|health care professional. Always ask your health care||
8130|007|Z|professional for complete information about this product and your||
8130|008|Z|specific health needs.||
8130|009|B|||
8130|010|T|MAFENIDE SOLUTION - TOPICAL||
8130|011|F|(MAF-en-ide AS-e-tate)||
8130|012|B|||
8130|013|C|COMMON BRAND NAME(S): Sulfamylon||
8130|014|B|||
8130|015|U|USES:  This medication is used alone or with other medications to||
8130|016|U|help prevent and treat wound infections in patients with severe||
8130|017|U|burns. Mafenide is a drug applied to the skin that belongs to a||
8130|018|U|class of drugs known as sulfa antibiotics. It works by killing||
8130|019|U|bacteria that may infect an open wound. Killing bacteria helps to||
8130|020|U|promote wound healing and to decrease the risk of the bacteria||
8130|021|U|spreading to surrounding skin or to the blood, thereby helping to||
8130|022|U|prevent a serious blood infection (sepsis).||
8130|023|B|||
8130|024|H|HOW TO USE:  Follow all instructions for proper preparation and||
8130|025|H|use of this drug. Consult your pharmacist.||
8130|026|H|   Wash hands before and after using this medication. Use with||
8130|027|H|wound dressings on the skin only. Soak the dressing completely||
8130|028|H|with this medication. Keep the dressing wet by applying this||
8130|029|H|medication as directed by your doctor, usually every 6 to 8||
8130|030|H|hours.||
8130|031|H|   Length of treatment is based on your medical condition and||
8130|032|H|response to treatment.||
8130|033|H|   Use this medication regularly in order to get the most benefit||
8130|034|H|from it. To help you remember, use it at the same times each day.||
8130|035|H|   Tell your doctor if your condition lasts or gets worse or if||
8130|036|H|you notice increasing redness/tenderness of the skin around the||
8130|037|H|wound.||
8130|038|B|||
8130|039|S|SIDE EFFECTS:  Pain, burning, or redness may occur. If any of||
8130|040|S|these effects last or get worse, tell your doctor or pharmacist||
8130|041|S|promptly.||
8130|042|S|   Remember that this medication has been prescribed because your||
8130|043|S|doctor has judged that the benefit to you is greater than the||
8130|044|S|risk of side effects. Many people using this medication do not||
8130|045|S|have serious side effects.||
8130|046|S|   Tell your doctor right away if you have any serious side||
8130|047|S|effects, including: blisters, fast breathing, nausea, vomiting,||
8130|048|S|diarrhea, headache, change in alertness, shaking (tremors),||
8130|049|S|seizures, weakness, dark urine, stomach/abdominal pain,||
8130|050|S|arm/leg/back pain, fast heartbeat.||
8130|051|S|   A very serious allergic reaction to this drug is rare.||
8130|052|S|However, get medical help right away if you notice any symptoms||
8130|053|S|of a serious allergic reaction, including: rash, itching/swelling||
8130|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8130|055|S|breathing.||
8130|056|S|   This is not a complete list of possible side effects. If you||
8130|057|S|notice other effects not listed above, contact your doctor or||
8130|058|S|pharmacist.||
8130|059|S|   In the US -||
8130|060|S|   Call your doctor for medical advice about side effects. You||
8130|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8130|062|S|www.fda.gov/medwatch.||
8130|063|S|   In Canada - Call your doctor for medical advice about side||
8130|064|S|effects. You may report side effects to Health Canada at||
8130|065|S|1-866-234-2345.||
8130|066|B|||
8130|067|P|PRECAUTIONS:  Before using mafenide, tell your doctor or||
8130|068|P|pharmacist if you are allergic to it; or if you have any other||
8130|069|P|allergies. This product may contain inactive ingredients, which||
8130|070|P|can cause allergic reactions or other problems. Talk to your||
8130|071|P|pharmacist for more details.||
8130|072|P|   Before using this medication, tell your doctor or pharmacist||
8130|073|P|your medical history, especially of: lung problems (such as||
8130|074|P|asthma), kidney disease, metabolism problems (such as||
8130|075|P|glucose-6-phosphate dehydrogenase deficiency-G6PD), blood||
8130|076|P|disorders.||
8130|077|P|   During pregnancy, this medication should be used only when||
8130|078|P|clearly needed. Discuss the risks and benefits with your doctor.||
8130|079|P|   It is unknown if this drug passes into breast milk. Consult||
8130|080|P|your doctor before breastfeeding.||
8130|081|B|||
8130|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8130|083|I|medications work or increase your risk for serious side effects.||
8130|084|I|This document does not contain all possible drug interactions.||
8130|085|I|Keep a list of all the products you use (including||
8130|086|I|prescription/nonprescription drugs and herbal products) and share||
8130|087|I|it with your doctor and pharmacist. Do not start, stop, or change||
8130|088|I|the dosage of any medicines without your doctor's approval.||
8130|089|B|||
8130|090|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8130|091|O|has overdosed and has serious symptoms such as passing out or||
8130|092|O|trouble breathing, call 911. Otherwise, call a poison control||
8130|093|O|center right away. US residents can call 1-800-222-1222. Canada||
8130|094|O|residents can call 1-844-764-7669.||
8130|095|B|||
8130|096|N|NOTES:  Do not share this medication with others.||
8130|097|N|   This medication has been prescribed for your current condition||
8130|098|N|only. Do not use it later on other wounds unless told to do so by||
8130|099|N|your doctor. A different medication may be necessary in that||
8130|100|N|case.||
8130|101|N|   Lab and/or medical tests (such as wound cultures, acid-base||
8130|102|N|balance, complete blood counts) should be done while you are||
8130|103|N|using this medication. Keep all medical and lab appointments.||
8130|104|N|Consult your doctor for more details.||
8130|105|B|||
8130|106|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8130|107|D|If it is near the time of the next dose, skip the missed dose.||
8130|108|D|Use your next dose at the regular time. Do not double the dose to||
8130|109|D|catch up.||
8130|110|B|||
8130|111|R|STORAGE:  Store the unmixed packets and mixed solution at room||
8130|112|R|temperature. The mixed solution expires after 28 days if the||
8130|113|R|container stays tightly closed. Once the container is opened for||
8130|114|R|use, the medication expires after 48 hours. Keep all medications||
8130|115|R|away from children and pets.||
8130|116|R|   Do not flush medications down the toilet or pour them into a||
8130|117|R|drain unless instructed to do so. Properly discard this product||
8130|118|R|when it is expired or no longer needed. Consult your pharmacist||
8130|119|R|or local waste disposal company.||
8130|120|B|||
8130|121|A|Information last revised September 2024.||
8130|122|A|Copyright(c) 2025 First Databank, Inc.||
8130|123|B|||
8133|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8133|002|Z|does NOT have all possible information about this product. This||
8133|003|Z|information does not assure that this product is safe, effective,||
8133|004|Z|or appropriate for you. This information is not individual||
8133|005|Z|medical advice and does not substitute for the advice of your||
8133|006|Z|health care professional. Always ask your health care||
8133|007|Z|professional for complete information about this product and your||
8133|008|Z|specific health needs.||
8133|009|B|||
8133|010|T|FLUTAMIDE - ORAL||
8133|011|F|(FLEW-tuh-mide)||
8133|012|B|||
8133|013|C|COMMON BRAND NAME(S): Eulexin||
8133|014|B|||
8133|015|W|WARNING:  Rarely, flutamide has caused severe (sometimes fatal)||
8133|016|W|liver problems. Immediately tell your doctor if you develop||
8133|017|W|symptoms of liver problems (such as nausea/vomiting that doesn't||
8133|018|W|stop, stomach/abdominal pain that doesn't go away, loss of||
8133|019|W|appetite, severe tiredness, dark urine, yellowing eyes/skin,||
8133|020|W|aching muscles, joint pain). Liver problems can happen at any||
8133|021|W|time while taking flutamide, but they occur most often during the||
8133|022|W|first 3 months of treatment. Your doctor will tell you whether to||
8133|023|W|stop or continue flutamide. Your doctor will monitor your liver||
8133|024|W|function with blood tests while you take flutamide. Keep all||
8133|025|W|medical and lab appointments. Avoid alcohol while taking||
8133|026|W|flutamide.||
8133|027|B|||
8133|028|U|USES:  This medication is used to treat men with prostate cancer.||
8133|029|U|Flutamide belongs to a class of drugs known as anti-androgens||
8133|030|U|(anti-testosterone). Testosterone, a natural hormone, helps||
8133|031|U|prostate cancer to grow and spread. Flutamide works by blocking||
8133|032|U|the effects of testosterone, thereby slowing the growth and||
8133|033|U|spread of prostate cancer.||
8133|034|B|||
8133|035|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8133|036|H|from your pharmacist before you start using flutamide and each||
8133|037|H|time you get a refill. If you have any questions, ask your doctor||
8133|038|H|or pharmacist.||
8133|039|H|   Take this medication by mouth with or without food as directed||
8133|040|H|by your doctor, usually 3 times daily.||
8133|041|H|   The dosage is based on your medical condition and response to||
8133|042|H|treatment.||
8133|043|H|   Use this medication regularly to get the most benefit from it.||
8133|044|H|To help you remember, take it at the same times each day. Do not||
8133|045|H|stop any medications for your prostate cancer unless told to do||
8133|046|H|so by your doctor. Stopping your medications could allow the||
8133|047|H|cancer to spread more rapidly.||
8133|048|H|   Tell your doctor if your condition lasts or gets worse (such||
8133|049|H|as urination becomes more difficult, bone pain increases).||
8133|050|B|||
8133|051|S|SIDE EFFECTS:  See also Warning section.||
8133|052|S|   Because flutamide is usually used with other medications, the||
8133|053|S|side effects may be caused by the other medications or their||
8133|054|S|combination. Hot flashes, loss of sexual interest/ability,||
8133|055|S|diarrhea, nausea, vomiting, and enlargement of male breasts may||
8133|056|S|occur. Less common side effects include drowsiness. If any of||
8133|057|S|these effects last or get worse, tell your doctor or pharmacist||
8133|058|S|promptly.||
8133|059|S|   Diarrhea is a common side effect. Drink plenty of fluids as||
8133|060|S|directed by your doctor to reduce your risk of dehydration. You||
8133|061|S|may decrease dairy products, increase whole||
8133|062|S|grains/vegetables/fruit, and stop any laxatives. Your doctor may||
8133|063|S|prescribe anti-diarrhea medication (such as loperamide) to||
8133|064|S|control your symptoms. Tell your doctor right away if you develop||
8133|065|S|diarrhea that is severe or doesn't stop, or signs of dehydration||
8133|066|S|(such as dizziness, decreased urination).||
8133|067|S|   Flutamide may change the color of your urine to light||
8133|068|S|orange-brown or yellow-green. This is not harmful.||
8133|069|S|   Remember that this medication has been prescribed because your||
8133|070|S|doctor has judged that the benefit to you is greater than the||
8133|071|S|risk of side effects. Many people using this medication do not||
8133|072|S|have serious side effects.||
8133|073|S|   Tell your doctor right away if you have any serious side||
8133|074|S|effects, including: mental/mood changes (such as depression,||
8133|075|S|anxiety, nervousness), a breast lump, confusion, sudden severe||
8133|076|S|tiredness, weakness, pale skin, bluish fingernails/lips/skin,||
8133|077|S|fast heartbeat at rest, feeling short of breath at rest.||
8133|078|S|   A very serious allergic reaction to this drug is rare.||
8133|079|S|However, get medical help right away if you notice any symptoms||
8133|080|S|of a serious allergic reaction, including: rash, itching/swelling||
8133|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8133|082|S|breathing.||
8133|083|S|   This is not a complete list of possible side effects. If you||
8133|084|S|notice other effects not listed above, contact your doctor or||
8133|085|S|pharmacist.||
8133|086|S|   In the US -||
8133|087|S|   Call your doctor for medical advice about side effects. You||
8133|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8133|089|S|www.fda.gov/medwatch.||
8133|090|S|   In Canada - Call your doctor for medical advice about side||
8133|091|S|effects. You may report side effects to Health Canada at||
8133|092|S|1-866-234-2345.||
8133|093|B|||
8133|094|P|PRECAUTIONS:  Before taking flutamide, tell your doctor or||
8133|095|P|pharmacist if you are allergic to it; or if you have any other||
8133|096|P|allergies. This product may contain inactive ingredients, which||
8133|097|P|can cause allergic reactions or other problems. Talk to your||
8133|098|P|pharmacist for more details.||
8133|099|P|   Before using this medication, tell your doctor or pharmacist||
8133|100|P|your medical history, especially of: liver problems, a certain||
8133|101|P|enzyme deficiency (glucose-6-phosphate dehydrogenase-G6PD),||
8133|102|P|smoking, hemoglobin M disease.||
8133|103|P|   This drug may rarely make you dizzy or drowsy. Alcohol or||
8133|104|P|marijuana (cannabis) can make you more dizzy or drowsy. Do not||
8133|105|P|drive, use machinery, or do anything that needs alertness until||
8133|106|P|you can do it safely. Avoid alcoholic beverages. Talk to your||
8133|107|P|doctor if you are using marijuana (cannabis).||
8133|108|P|   Before having surgery, tell your doctor or dentist about all||
8133|109|P|the products you use (including prescription drugs,||
8133|110|P|nonprescription drugs, and herbal products).||
8133|111|P|   Older adults may be more sensitive to the side effects of this||
8133|112|P|drug, especially drowsiness.||
8133|113|P|   This medication is not usually used in women. It is unlikely||
8133|114|P|to be used during pregnancy or breastfeeding. Women who are||
8133|115|P|pregnant or breastfeeding should avoid touching or accidentally||
8133|116|P|taking this medication.||
8133|117|B|||
8133|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8133|119|I|medications work or increase your risk for serious side effects.||
8133|120|I|This document does not contain all possible drug interactions.||
8133|121|I|Keep a list of all the products you use (including||
8133|122|I|prescription/nonprescription drugs and herbal products) and share||
8133|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
8133|124|I|the dosage of any medicines without your doctor's approval.||
8133|125|I|   Some of the products that may interact with this drug include:||
8133|126|I|testosterone (patch, gel, injection), anabolic steroids||
8133|127|I|(including over-the-counter androgens/anabolics/testosterone||
8133|128|I|precursors), DHEA, warfarin.||
8133|129|B|||
8133|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8133|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8133|132|O|poison control center right away. US residents can call||
8133|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8133|134|B|||
8133|135|N|NOTES:  Do not share this medication with others.||
8133|136|N|   Lab and/or medical tests (such as liver function, blood PSA||
8133|137|N|test) should be done while you are taking this medication. Keep||
8133|138|N|all medical and lab appointments. Consult your doctor for more||
8133|139|N|details.||
8133|140|B|||
8133|141|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8133|142|D|remember. If it is near the time of the next dose, skip the||
8133|143|D|missed dose. Take your next dose at the regular time. Do not||
8133|144|D|double the dose to catch up.||
8133|145|B|||
8133|146|R|STORAGE:  Store at room temperature away from light and moisture.||
8133|147|R|Do not store in the bathroom. Keep all medications away from||
8133|148|R|children and pets.||
8133|149|R|   Do not flush medications down the toilet or pour them into a||
8133|150|R|drain unless instructed to do so. Properly discard this product||
8133|151|R|when it is expired or no longer needed. Consult your pharmacist||
8133|152|R|or local waste disposal company.||
8133|153|B|||
8133|154|A|Information last revised June 2024.||
8133|155|A|Copyright(c) 2025 First Databank, Inc.||
8133|156|B|||
8134|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8134|002|Z|does NOT have all possible information about this product. This||
8134|003|Z|information does not assure that this product is safe, effective,||
8134|004|Z|or appropriate for you. This information is not individual||
8134|005|Z|medical advice and does not substitute for the advice of your||
8134|006|Z|health care professional. Always ask your health care||
8134|007|Z|professional for complete information about this product and your||
8134|008|Z|specific health needs.||
8134|009|B|||
8134|010|T|DAUNORUBICIN - INJECTION||
8134|011|F|(dawn-oh-REWB-eh-sin)||
8134|012|B|||
8134|013|C|COMMON BRAND NAME(S): Cerubidine||
8134|014|B|||
8134|015|W|WARNING:  Daunorubicin must be given only by injection into a||
8134|016|W|vein. This medication must not be given by injection into a||
8134|017|W|muscle or under the skin. If this medication accidentally leaks||
8134|018|W|into the skin/muscle around the injection site, it may cause||
8134|019|W|severe damage. Tell your doctor right away if you notice redness,||
8134|020|W|pain, or swelling at or near the injection site.||
8134|021|W|   This medication may rarely cause serious (rarely fatal) heart||
8134|022|W|problems (including heart failure). This may occur both during||
8134|023|W|treatment or months to years after treatment is completed. The||
8134|024|W|risk of heart problems is affected by your dose, medical history||
8134|025|W|(including previous heart disease, radiation treatment to the||
8134|026|W|chest area), and previous use of this and other drugs (including||
8134|027|W|doxorubicin). Tell your doctor right away if you notice symptoms||
8134|028|W|such as irregular heartbeat, shortness of breath, swelling||
8134|029|W|ankles/feet, unusual tiredness, or unusual/sudden weight gain.||
8134|030|W|   Daunorubicin may cause certain severe blood and bone marrow||
8134|031|W|disorders (low red blood cells/white blood cells/platelets). This||
8134|032|W|can affect your body's ability to stop bleeding or fight||
8134|033|W|infection. Tell your doctor right away if you develop easy||
8134|034|W|bleeding/bruising or signs of infection (such as sore throat that||
8134|035|W|doesn't go away, fever, chills).||
8134|036|W|   Very rarely, people with cancer who are treated with this type||
8134|037|W|of medication have developed other cancers (such as secondary||
8134|038|W|leukemia). The risk may be increased when this medication is||
8134|039|W|given with certain anti-cancer drugs or radiation treatment.||
8134|040|W|Consult your doctor for more details.||
8134|041|W|   Before starting treatment with this medication, tell your||
8134|042|W|doctor if you have liver or kidney problems. Your dose may need||
8134|043|W|to be adjusted.||
8134|044|B|||
8134|045|U|USES:  Daunorubicin is used to treat leukemia and other cancers.||
8134|046|U|It belongs to a class of drugs known as anthracyclines and works||
8134|047|U|by slowing or stopping the growth of cancer cells.||
8134|048|B|||
8134|049|H|HOW TO USE:  This medication is given by injection into a vein by||
8134|050|H|a health care professional. The dosage is based on your medical||
8134|051|H|condition, body size, and response to treatment.||
8134|052|H|   If this medication touches your skin, immediately wash the||
8134|053|H|area well with soap and water. If this medication gets in your||
8134|054|H|eye, open the eyelids and flush with water for 15 minutes, then||
8134|055|H|get medical help right away. Caregivers should take precautions||
8134|056|H|(such as wearing gloves) to prevent contact with the patient's||
8134|057|H|urine and other body fluids.||
8134|058|H|   Drink plenty of fluids while using this medication unless||
8134|059|H|otherwise directed by your doctor. Doing so helps decrease the||
8134|060|H|risk of certain side effects (such as increased uric acid).||
8134|061|B|||
8134|062|S|SIDE EFFECTS:  See also Warning section.||
8134|063|S|   Nausea, vomiting, constipation, diarrhea, and loss of appetite||
8134|064|S|may occur. In some cases, your doctor may prescribe medication to||
8134|065|S|prevent or relieve nausea and vomiting. Eating several small||
8134|066|S|meals, not eating before treatment, or limiting activity may help||
8134|067|S|lessen some of these effects. If any of these effects last or get||
8134|068|S|worse, tell your doctor or pharmacist promptly.||
8134|069|S|   This medication may cause your urine to turn a reddish color.||
8134|070|S|This is a normal, harmless effect of the drug and should not be||
8134|071|S|mistaken for blood in your urine.||
8134|072|S|   Temporary hair loss is a common side effect. Normal hair||
8134|073|S|growth should return after treatment has ended.||
8134|074|S|   Remember that this medication has been prescribed because your||
8134|075|S|doctor has judged that the benefit to you is greater than the||
8134|076|S|risk of side effects. Many people using this medication do not||
8134|077|S|have serious side effects.||
8134|078|S|   Tell your doctor right away if you have any serious side||
8134|079|S|effects, including: unusual bleeding/bruising (such as small red||
8134|080|S|spots on the skin, black/bloody stools, bloody urine, vomit that||
8134|081|S|looks like coffee grounds).||
8134|082|S|   Pain or sores in the mouth and throat may occur. Brush your||
8134|083|S|teeth gently/carefully, avoid using mouthwash that contains||
8134|084|S|alcohol, and rinse your mouth often with cool water mixed with||
8134|085|S|baking soda or salt. It may also be best to eat soft, moist||
8134|086|S|foods.||
8134|087|S|   A very serious allergic reaction to this drug is rare.||
8134|088|S|However, get medical help right away if you notice any symptoms||
8134|089|S|of a serious allergic reaction, including: rash, itching/swelling||
8134|090|S|(especially of the face/tongue/throat), trouble breathing, severe||
8134|091|S|dizziness.||
8134|092|S|   This is not a complete list of possible side effects. If you||
8134|093|S|notice other effects not listed above, contact your doctor or||
8134|094|S|pharmacist.||
8134|095|S|   In the US -||
8134|096|S|   Call your doctor for medical advice about side effects. You||
8134|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8134|098|S|www.fda.gov/medwatch.||
8134|099|S|   In Canada - Call your doctor for medical advice about side||
8134|100|S|effects. You may report side effects to Health Canada at||
8134|101|S|1-866-234-2345.||
8134|102|B|||
8134|103|P|PRECAUTIONS:  Before using daunorubicin, tell your doctor or||
8134|104|P|pharmacist if you are allergic to it; or to other anthracyclines||
8134|105|P|(such as doxorubicin); or if you have any other allergies. This||
8134|106|P|product may contain inactive ingredients, which can cause||
8134|107|P|allergic reactions or other problems. Talk to your pharmacist for||
8134|108|P|more details.||
8134|109|P|   Before using this medication, tell your doctor or pharmacist||
8134|110|P|your medical history, especially of: blood/bleeding disorders||
8134|111|P|(such as anemia, low blood cell counts), gout, heart disease||
8134|112|P|(such as heart failure, irregular heartbeat), kidney disease,||
8134|113|P|liver disease, radiation treatment (especially to chest area).||
8134|114|P|   Daunorubicin can make you more likely to get infections or may||
8134|115|P|make current infections worse. Stay away from anyone who has an||
8134|116|P|infection that may easily spread (such as chickenpox, COVID-19,||
8134|117|P|measles, flu). Talk to your doctor if you have been exposed to an||
8134|118|P|infection or for more details.||
8134|119|P|   Tell your health care professional that you are using||
8134|120|P|daunorubicin before having any immunizations/vaccinations. Avoid||
8134|121|P|contact with people who have recently received live vaccines||
8134|122|P|(such as flu vaccine inhaled through the nose).||
8134|123|P|   To lower your risk of getting cut, bruised, or injured, use||
8134|124|P|caution with sharp objects like razors and nail cutters, and||
8134|125|P|avoid activities such as contact sports.||
8134|126|P|   Before having surgery, tell your doctor or dentist about all||
8134|127|P|the products you use (including prescription drugs,||
8134|128|P|nonprescription drugs, and herbal products).||
8134|129|P|   Children may be more sensitive to the side effects of this||
8134|130|P|drug, especially effects on the heart.||
8134|131|P|   Tell your doctor if you are pregnant or plan to become||
8134|132|P|pregnant. You should not become pregnant while using||
8134|133|P|daunorubicin. Daunorubicin may harm an unborn baby. Men and women||
8134|134|P|using this medication should ask about reliable forms of birth||
8134|135|P|control during treatment. If you or your partner becomes||
8134|136|P|pregnant, talk to your doctor right away about the risks and||
8134|137|P|benefits of this medication.||
8134|138|P|   It is unknown if this drug passes into breast milk. Because of||
8134|139|P|the possible risk to the infant, breastfeeding is not recommended||
8134|140|P|while using this drug. Consult your doctor before breastfeeding.||
8134|141|B|||
8134|142|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8134|143|I|medications work or increase your risk for serious side effects.||
8134|144|I|This document does not contain all possible drug interactions.||
8134|145|I|Keep a list of all the products you use (including||
8134|146|I|prescription/nonprescription drugs and herbal products) and share||
8134|147|I|it with your doctor and pharmacist. Do not start, stop, or change||
8134|148|I|the dosage of any medicines without your doctor's approval.||
8134|149|I|   Some products that may interact with this drug include: other||
8134|150|I|anti-cancer drugs (especially anthracyclines such as||
8134|151|I|doxorubicin).||
8134|152|B|||
8134|153|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8134|154|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8134|155|O|poison control center right away. US residents can call||
8134|156|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8134|157|B|||
8134|158|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
8134|159|N|complete blood count, EKG) should be done while you are using||
8134|160|N|this medication. Keep all medical and lab appointments. Consult||
8134|161|N|your doctor for more details.||
8134|162|B|||
8134|163|D|MISSED DOSE:  It is important to get each dose of this medication||
8134|164|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8134|165|D|right away for a new dosing schedule.||
8134|166|B|||
8134|167|R|STORAGE:  Not applicable. This medication is given in a hospital||
8134|168|R|or clinic and will not be stored at home.||
8134|169|B|||
8134|170|M|MEDICAL ALERT:  Your condition can cause complications in a||
8134|171|M|medical emergency. For information about enrolling in MedicAlert,||
8134|172|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8134|173|B|||
8134|174|A|Information last revised May 2024.||
8134|175|A|Copyright(c) 2025 First Databank, Inc.||
8134|176|B|||
8135|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8135|002|Z|does NOT have all possible information about this product. This||
8135|003|Z|information does not assure that this product is safe, effective,||
8135|004|Z|or appropriate for you. This information is not individual||
8135|005|Z|medical advice and does not substitute for the advice of your||
8135|006|Z|health care professional. Always ask your health care||
8135|007|Z|professional for complete information about this product and your||
8135|008|Z|specific health needs.||
8135|009|B|||
8135|010|T|CISPLATIN - INJECTION||
8135|011|F|(sis-PLAT-in)||
8135|012|B|||
8135|013|C|COMMON BRAND NAME(S): Platinol-AQ||
8135|014|B|||
8135|015|W|WARNING:  Cisplatin may cause severe kidney problems, nerve||
8135|016|W|problems, and severe nausea and vomiting. Nerve problems may||
8135|017|W|occur during treatment or weeks after stopping treatment. Your||
8135|018|W|risk of these problems increases with higher doses or longer||
8135|019|W|treatment with cisplatin. Tell your doctor right way if you||
8135|020|W|develop any of the following symptoms: change in the amount of||
8135|021|W|urine, numbness/tingling of arms/legs, loss of reflexes, loss of||
8135|022|W|balance, trouble walking, nausea, or vomiting.||
8135|023|W|   This medication decreases bone marrow function, an effect that||
8135|024|W|may lead to a low number of blood cells such as red cells, white||
8135|025|W|cells, and platelets. This effect can cause anemia, decrease your||
8135|026|W|body's ability to fight an infection, or cause easy||
8135|027|W|bruising/bleeding. Tell your doctor right away if you develop any||
8135|028|W|of the following symptoms: unusual tiredness, pale skin, easy||
8135|029|W|bruising/bleeding, or signs of infection (such as sore throat||
8135|030|W|that doesn't go away, fever, chills).||
8135|031|B|||
8135|032|U|USES:  Cisplatin is used to treat various types of cancer. It is||
8135|033|U|a chemotherapy drug that contains platinum. It is used to slow or||
8135|034|U|stop cancer cell growth.||
8135|035|B|||
8135|036|H|HOW TO USE:  This medication is usually given by injection into a||
8135|037|H|vein by a health care professional. The dosage is based on your||
8135|038|H|medical condition, body size, and response to treatment.||
8135|039|H|   During treatment with this medication, it is important that||
8135|040|H|you take in more fluids than usual and pass urine often to help||
8135|041|H|avoid kidney side effects. Intravenous fluids should be given||
8135|042|H|with this medication. Also, ask your doctor how much fluid you||
8135|043|H|should drink and follow these instructions carefully.||
8135|044|H|   If this medication comes into contact with your skin, wash||
8135|045|H|your skin right away and completely with soap and water.||
8135|046|B|||
8135|047|S|SIDE EFFECTS:  See also Warning section.||
8135|048|S|   Loss of taste, diarrhea, nausea, vomiting, or loss of appetite||
8135|049|S|may occur. Nausea and vomiting can be severe. Your doctor may||
8135|050|S|prescribe medication to prevent or relieve nausea and vomiting.||
8135|051|S|Eating several small meals, not eating before treatment, or||
8135|052|S|limiting activity may help lessen some of these effects. If any||
8135|053|S|of these effects last or get worse, tell your doctor or||
8135|054|S|pharmacist promptly.||
8135|055|S|   Temporary hair loss may occur. Normal hair growth should||
8135|056|S|return after treatment has ended.||
8135|057|S|   Remember that this medication has been prescribed because your||
8135|058|S|doctor has judged that the benefit to you is greater than the||
8135|059|S|risk of side effects. Many people using this medication do not||
8135|060|S|have serious side effects.||
8135|061|S|   Tell your doctor right away if you have any serious side||
8135|062|S|effects, including: pain/burning/redness at the injection site,||
8135|063|S|muscle cramps/spasms/weakness, ringing in the ears, hearing loss,||
8135|064|S|joint pain, mental/mood changes (such as confusion), headache,||
8135|065|S|blood in urine, painful/difficult urination, lower back/side||
8135|066|S|pain.||
8135|067|S|   Vision changes (such as blurred vision, vision loss, seeing||
8135|068|S|colors differently) may occur with cisplatin use. Normal vision||
8135|069|S|usually returns after the end of treatment. Consult your doctor||
8135|070|S|or pharmacist for more details and report this side effect right||
8135|071|S|away if it occurs.||
8135|072|S|   Get medical help right away if you have any very serious side||
8135|073|S|effects, including: chest pain, pain/redness/swelling of arms or||
8135|074|S|legs, seizures.||
8135|075|S|   Rarely, this medication may increase the risk of getting other||
8135|076|S|cancers (such as leukemia). Consult your doctor for more details.||
8135|077|S|   A very serious allergic reaction to this drug is rare.||
8135|078|S|However, get medical help right away if you notice any symptoms||
8135|079|S|of a serious allergic reaction, including: rash, itching/swelling||
8135|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8135|081|S|breathing.||
8135|082|S|   This is not a complete list of possible side effects. If you||
8135|083|S|notice other effects not listed above, contact your doctor or||
8135|084|S|pharmacist.||
8135|085|S|   In the US -||
8135|086|S|   Call your doctor for medical advice about side effects. You||
8135|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8135|088|S|www.fda.gov/medwatch.||
8135|089|S|   In Canada - Call your doctor for medical advice about side||
8135|090|S|effects. You may report side effects to Health Canada at||
8135|091|S|1-866-234-2345.||
8135|092|B|||
8135|093|P|PRECAUTIONS:  Before using cisplatin, tell your doctor or||
8135|094|P|pharmacist if you are allergic to it; or to carboplatin; or if||
8135|095|P|you have any other allergies. This product may contain inactive||
8135|096|P|ingredients, which can cause allergic reactions or other||
8135|097|P|problems. Talk to your pharmacist for more details.||
8135|098|P|   Before using this medication, tell your doctor or pharmacist||
8135|099|P|your medical history, especially of: kidney disease, decreased||
8135|100|P|bone marrow function/blood cell disorders (such as anemia,||
8135|101|P|leukopenia, thrombocytopenia), hearing problems, mineral||
8135|102|P|imbalance (low blood levels of sodium, potassium, magnesium,||
8135|103|P|calcium, phosphate), numbness/tingling of arms/legs, kidney||
8135|104|P|stones, gout.||
8135|105|P|   Do not have immunizations/vaccinations without the consent of||
8135|106|P|your doctor and avoid contact with people who have recently||
8135|107|P|received oral polio vaccine.||
8135|108|P|   Use caution with sharp objects like safety razors or nail||
8135|109|P|cutters and avoid activities such as contact sports to lower the||
8135|110|P|chance of getting cut, bruised or injured.||
8135|111|P|   Wash your hands well to prevent the spread of infections.||
8135|112|P|   Older adults may be more sensitive to the side effects of this||
8135|113|P|drug, especially kidney problems, nerve problems||
8135|114|P|(numbness/tingling of arms/legs), and decreased bone marrow||
8135|115|P|function.||
8135|116|P|   Children may be more sensitive to the side effects of this||
8135|117|P|drug, especially hearing loss.||
8135|118|P|   This medication can affect fertility in both males and||
8135|119|P|females. Ask your doctor for more details.||
8135|120|P|   Tell your doctor if you are pregnant or plan to become||
8135|121|P|pregnant. You should not become pregnant while using cisplatin.||
8135|122|P|Cisplatin may harm an unborn baby. Your doctor should order a||
8135|123|P|pregnancy test before you start this medication. Women using this||
8135|124|P|medication should ask about reliable forms of birth control||
8135|125|P|during treatment and for some time after the last dose. Men using||
8135|126|P|this medication should ask about reliable forms of birth control||
8135|127|P|during treatment and for some time after the last dose. If you or||
8135|128|P|your partner becomes pregnant, talk to your doctor right away||
8135|129|P|about the risks and benefits of this medication.||
8135|130|P|   This drug passes into breast milk. Because of the possible||
8135|131|P|risk to the infant, breastfeeding is not recommended while using||
8135|132|P|this drug. Consult your doctor before breastfeeding.||
8135|133|B|||
8135|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8135|135|I|medications work or increase your risk for serious side effects.||
8135|136|I|This document does not contain all possible drug interactions.||
8135|137|I|Keep a list of all the products you use (including||
8135|138|I|prescription/nonprescription drugs and herbal products) and share||
8135|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
8135|140|I|the dosage of any medicines without your doctor's approval.||
8135|141|I|   Some products that may interact with this drug include:||
8135|142|I|aminoglycoside antibiotics (such as gentamicin, neomycin),||
8135|143|I|amphotericin B, anti-seizure medications (such as phenytoin).||
8135|144|B|||
8135|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8135|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8135|147|O|poison control center right away. US residents can call||
8135|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8135|149|B|||
8135|150|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
8135|151|N|complete blood count, blood mineral levels, hearing tests) should||
8135|152|N|be done while you are using this medication. Keep all medical and||
8135|153|N|lab appointments. Consult your doctor for more details.||
8135|154|B|||
8135|155|D|MISSED DOSE:  It is important to get each dose of this medication||
8135|156|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8135|157|D|right away for a new dosing schedule.||
8135|158|B|||
8135|159|R|STORAGE:  Consult the product instructions and your pharmacist||
8135|160|R|for storage details. Keep all medications away from children and||
8135|161|R|pets.||
8135|162|R|   Do not flush medications down the toilet or pour them into a||
8135|163|R|drain unless instructed to do so. Properly discard this product||
8135|164|R|when it is expired or no longer needed. Consult your pharmacist||
8135|165|R|or local waste disposal company.||
8135|166|B|||
8135|167|M|MEDICAL ALERT:  Your condition can cause complications in a||
8135|168|M|medical emergency. For information about enrolling in MedicAlert,||
8135|169|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8135|170|B|||
8135|171|A|Information last revised October 2025.||
8135|172|A|Copyright(c) 2025 First Databank, Inc.||
8135|173|B|||
8137|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8137|002|Z|does NOT have all possible information about this product. This||
8137|003|Z|information does not assure that this product is safe, effective,||
8137|004|Z|or appropriate for you. This information is not individual||
8137|005|Z|medical advice and does not substitute for the advice of your||
8137|006|Z|health care professional. Always ask your health care||
8137|007|Z|professional for complete information about this product and your||
8137|008|Z|specific health needs.||
8137|009|B|||
8137|010|T|ESTRAMUSTINE PHOSPHATE - ORAL||
8137|011|F|(ess-TRAM-you-steen FOSS fate)||
8137|012|B|||
8137|013|C|COMMON BRAND NAME(S): Emcyt||
8137|014|B|||
8137|015|U|USES:  This medication is used to treat some types of prostate||
8137|016|U|cancer. In the body, estramustine breaks down into estrogens||
8137|017|U|(estrone, estradiol) and a type of cancer drug (estromustine).||
8137|018|U|This medication is thought to work by increasing estrogens, which||
8137|019|U|interfere with prostate cancer, and by slowing/stopping the||
8137|020|U|growth of cancer cells.||
8137|021|B|||
8137|022|H|HOW TO USE:  Take this medication by mouth on an empty stomach (1||
8137|023|H|hour before or 2 hours after a meal) as directed by your doctor,||
8137|024|H|usually 3 to 4 times a day.||
8137|025|H|   Take this medication with a full glass of water (8 ounces or||
8137|026|H|240 milliliters) unless your doctor directs you otherwise.||
8137|027|H|   Take this medication regularly in order to get the most||
8137|028|H|benefit from it. Remember to take it at the same times each day||
8137|029|H|as directed. The dosage is based on your medical condition,||
8137|030|H|weight, and response to treatment.||
8137|031|H|   Take this medication 3 hours before or after taking any||
8137|032|H|products containing magnesium, aluminum, or calcium. Some||
8137|033|H|examples include quinapril, vitamins/minerals, and antacids.||
8137|034|H|Dairy products (such as milk, yogurt), juice with added calcium,||
8137|035|H|sucralfate, bismuth subsalicylate, iron, and zinc are also||
8137|036|H|included. These products bind with estramustine, preventing its||
8137|037|H|full absorption.||
8137|038|H|   Do not increase your dose or take this medication more often||
8137|039|H|than prescribed. Your condition will not improve any faster, and||
8137|040|H|the risk of serious side effects may be increased.||
8137|041|H|   Since this drug can be absorbed through the skin and lungs,||
8137|042|H|women who are pregnant or who may become pregnant should not||
8137|043|H|handle this medication or breathe the dust from the capsules.||
8137|044|B|||
8137|045|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, flushing, dry||
8137|046|S|skin, headache, leg cramps, decreased sexual interest/ability,||
8137|047|S|and male breast tenderness/enlargement may occur. If any of these||
8137|048|S|effects last or get worse, tell your doctor or pharmacist||
8137|049|S|promptly||
8137|050|S|   Remember that this medication has been prescribed because your||
8137|051|S|doctor has judged that the benefit to you is greater than the||
8137|052|S|risk of side effects. Many people using this medication do not||
8137|053|S|have serious side effects.||
8137|054|S|   This medication may raise your blood pressure. Check your||
8137|055|S|blood pressure regularly and tell your doctor if the results are||
8137|056|S|high.||
8137|057|S|   Tell your doctor right away if you have any serious side||
8137|058|S|effects, including: mental/mood changes (such as depression),||
8137|059|S|swelling of hands/feet, worsening of seizures, increased||
8137|060|S|thirst/urination, nausea/vomiting that doesn't stop, easy||
8137|061|S|bruising/bleeding, stomach/abdominal pain, dark urine, yellowing||
8137|062|S|eyes/skin.||
8137|063|S|   This medication may rarely cause serious problems such as||
8137|064|S|heart attack, stroke, and blood clots. Get medical help right||
8137|065|S|away if you experience any of the following symptoms:||
8137|066|S|chest/jaw/left arm pain, sudden/severe headaches, weakness on one||
8137|067|S|side of the body, confusion, trouble speaking, sudden vision||
8137|068|S|changes, pain/swelling/warmth in the groin/calf, shortness of||
8137|069|S|breath/rapid breathing, sudden dizziness/fainting, unusual||
8137|070|S|sweating.||
8137|071|S|   This medication can lower the body's ability to fight an||
8137|072|S|infection. Tell your doctor right away if you develop any signs||
8137|073|S|of an infection (such as sore throat that doesn't go away, fever,||
8137|074|S|chills).||
8137|075|S|   A very serious allergic reaction to this drug is rare.||
8137|076|S|However, get medical help right away if you notice any symptoms||
8137|077|S|of a serious allergic reaction, including: rash, itching/swelling||
8137|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8137|079|S|breathing.||
8137|080|S|   This is not a complete list of possible side effects. If you||
8137|081|S|notice other effects not listed above, contact your doctor or||
8137|082|S|pharmacist.||
8137|083|S|   In the US -||
8137|084|S|   Call your doctor for medical advice about side effects. You||
8137|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8137|086|S|www.fda.gov/medwatch.||
8137|087|S|   In Canada - Call your doctor for medical advice about side||
8137|088|S|effects. You may report side effects to Health Canada at||
8137|089|S|1-866-234-2345.||
8137|090|B|||
8137|091|P|PRECAUTIONS:  Before taking estramustine, tell your doctor or||
8137|092|P|pharmacist if you are allergic to it; or to estradiol or other||
8137|093|P|estrogens; or to nitrogen mustard (such as mechlorethamine); or||
8137|094|P|if you have any other allergies. This product may contain||
8137|095|P|inactive ingredients, which can cause allergic reactions or other||
8137|096|P|problems. Talk to your pharmacist for more details.||
8137|097|P|   Before using this medication, tell your doctor or pharmacist||
8137|098|P|your medical history, especially of: blood clots (such as in the||
8137|099|P|legs, eyes, lungs), bone disease (such as bone metastases, high||
8137|100|P|calcium levels), high cholesterol or triglyceride (blood fat)||
8137|101|P|levels, depression, diabetes, severe headaches (such as||
8137|102|P|migraine), heart disease (such as angina, heart attack, heart||
8137|103|P|failure), high blood pressure, kidney disease, liver disease,||
8137|104|P|seizure, long periods of sitting or lying down (for example, due||
8137|105|P|to being bedridden), stroke, thyroid problems.||
8137|106|P|   Do not smoke cigarettes or use tobacco. Estrogens combined||
8137|107|P|with smoking further increase your risk for stroke, blood clots,||
8137|108|P|high blood pressure, and heart attacks.||
8137|109|P|   If you will be having surgery or will be confined to a chair||
8137|110|P|or bed for a long time (such as on a long plane flight), notify||
8137|111|P|your doctor beforehand. Special precautions may need to be taken||
8137|112|P|in these circumstances while you are taking this drug because of||
8137|113|P|the increased risk for blood clots.||
8137|114|P|   If you have diabetes, estramustine may affect your blood||
8137|115|P|sugar. Check your blood sugar regularly as directed and share the||
8137|116|P|results with your doctor.||
8137|117|P|   If you are nearsighted or wear contact lenses, you may develop||
8137|118|P|vision problems or trouble wearing your contact lenses. Contact||
8137|119|P|your eye doctor if these problems occur.||
8137|120|P|   This medication may cause blotchy, dark areas on your face and||
8137|121|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
8137|122|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
8137|123|P|wear protective clothing when outdoors.||
8137|124|P|   This medication may affect the production of sperm. Use a||
8137|125|P|reliable form of birth control while on this medication. Consult||
8137|126|P|your doctor.||
8137|127|P|   This medication is not usually used in women. It is unlikely||
8137|128|P|to be used during pregnancy or breastfeeding. Consult your doctor||
8137|129|P|if you have any questions about this medication.||
8137|130|B|||
8137|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8137|132|I|medications work or increase your risk for serious side effects.||
8137|133|I|This document does not contain all possible drug interactions.||
8137|134|I|Keep a list of all the products you use (including||
8137|135|I|prescription/nonprescription drugs and herbal products) and share||
8137|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
8137|137|I|the dosage of any medicines without your doctor's approval.||
8137|138|I|   Some products that may interact with this drug are: aromatase||
8137|139|I|inhibitors (such as anastrozole, exemestane), corticosteroids||
8137|140|I|(such as prednisolone), ospemifene, tamoxifen, troleandomycin,||
8137|141|I|tranexamic acid, medication for low thyroid (hypothyroidism).||
8137|142|I|   Certain drugs can affect the estrogen levels in your system.||
8137|143|I|Drugs that may cause this effect include: azole antifungals (such||
8137|144|I|as itraconazole, ketoconazole), many antibiotics (such as||
8137|145|I|cephalosporins, macrolides, penicillins, tetracyclines, sulfas),||
8137|146|I|aprepitant, bexarotene, bosentan, dapsone, griseofulvin, certain||
8137|147|I|HIV protease inhibitors (such as nelfinavir), modafinil,||
8137|148|I|nevirapine, rifamycins (such as rifampin), ritonavir, many||
8137|149|I|seizure medications (such as barbiturates, carbamazepine,||
8137|150|I|phenytoin, primidone, topiramate), St John's wort.||
8137|151|B|||
8137|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8137|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8137|154|O|poison control center right away. US residents can call||
8137|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8137|156|B|||
8137|157|N|NOTES:  Do not share this medication with others.||
8137|158|N|   Lab tests (such as blood pressure, liver function, calcium||
8137|159|N|levels) should be done while you are taking this medication. Keep||
8137|160|N|all medical and lab appointments. Consult your doctor for more||
8137|161|N|details.||
8137|162|B|||
8137|163|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8137|164|D|remember. If it is near the time of the next dose, skip the||
8137|165|D|missed dose. Take your next dose at the regular time. Do not||
8137|166|D|double the dose to catch up.||
8137|167|B|||
8137|168|R|STORAGE:  Store in the refrigerator away from light and moisture.||
8137|169|R|Keep all medications away from children and pets.||
8137|170|R|   Do not flush medications down the toilet or pour them into a||
8137|171|R|drain unless instructed to do so. Properly discard this product||
8137|172|R|when it is expired or no longer needed. Consult your pharmacist||
8137|173|R|or local waste disposal company.||
8137|174|B|||
8137|175|A|Information last revised September 2025.||
8137|176|A|Copyright(c) 2025 First Databank, Inc.||
8137|177|B|||
8139|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8139|002|Z|does NOT have all possible information about this product. This||
8139|003|Z|information does not assure that this product is safe, effective,||
8139|004|Z|or appropriate for you. This information is not individual||
8139|005|Z|medical advice and does not substitute for the advice of your||
8139|006|Z|health care professional. Always ask your health care||
8139|007|Z|professional for complete information about this product and your||
8139|008|Z|specific health needs.||
8139|009|B|||
8139|010|T|CALCIUM ACETATE - ORAL||
8139|011|F|(KAL-see-um AS-e-tate)||
8139|012|B|||
8139|013|C|COMMON BRAND NAME(S): Phoslyra, PhosLo||
8139|014|B|||
8139|015|U|USES:  Calcium acetate is used to prevent high blood phosphate||
8139|016|U|levels in patients who are on dialysis due to severe kidney||
8139|017|U|disease. Dialysis removes some phosphate from your blood, but it||
8139|018|U|is difficult to remove enough to keep your phosphate levels||
8139|019|U|balanced. Decreasing blood phosphate levels can help keep your||
8139|020|U|bones strong, prevent unsafe buildup of minerals in your body,||
8139|021|U|and possibly decrease the risk of heart disease and strokes that||
8139|022|U|can result from high phosphate levels. Calcium acetate is a||
8139|023|U|natural mineral that works by holding onto phosphate from the||
8139|024|U|diet so that it can pass out of your body.||
8139|025|B|||
8139|026|H|HOW TO USE:  If you are taking the over-the-counter product to||
8139|027|H|self-treat, read and follow all directions on the product package||
8139|028|H|before taking this medication. If you have any questions, consult||
8139|029|H|your pharmacist. If your doctor has prescribed this medication,||
8139|030|H|take it as directed.||
8139|031|H|   This medication is usually taken by mouth with each meal. The||
8139|032|H|dosage is based on your medical condition and response to||
8139|033|H|treatment.||
8139|034|H|   If you are using the liquid form, use a medication-measuring||
8139|035|H|device or spoon to carefully measure the prescribed dose. Do not||
8139|036|H|use a household spoon because you may not get the correct dose.||
8139|037|H|   Use this medication regularly in order to get the most benefit||
8139|038|H|from it. Remember to take it with each meal every day or on the||
8139|039|H|schedule given to you by your doctor.||
8139|040|H|   Take this medication exactly as directed. Do not increase your||
8139|041|H|dose or take this more often than prescribed. Doing so may||
8139|042|H|increase your risk of side effects.||
8139|043|B|||
8139|044|S|SIDE EFFECTS:  Stomach upset may occur. If this effect lasts or||
8139|045|S|gets worse, tell your doctor or pharmacist promptly.||
8139|046|S|   If your doctor has directed you to use this medication,||
8139|047|S|remember that your doctor has judged that the benefit to you is||
8139|048|S|greater than the risk of side effects. Many people using this||
8139|049|S|medication do not have serious side effects.||
8139|050|S|   Tell your doctor right away if you have any serious side||
8139|051|S|effects, including: stomach/abdominal pain, loss of appetite,||
8139|052|S|nausea, vomiting, constipation, confusion, dry mouth, increased||
8139|053|S|thirst/urination.||
8139|054|S|   A very serious allergic reaction to this drug is rare.||
8139|055|S|However, get medical help right away if you notice any symptoms||
8139|056|S|of a serious allergic reaction, including: rash, itching/swelling||
8139|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8139|058|S|breathing.||
8139|059|S|   This is not a complete list of possible side effects. If you||
8139|060|S|notice other effects not listed above, contact your doctor or||
8139|061|S|pharmacist.||
8139|062|S|   In the US -||
8139|063|S|   Call your doctor for medical advice about side effects. You||
8139|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8139|065|S|www.fda.gov/medwatch.||
8139|066|S|   In Canada - Call your doctor for medical advice about side||
8139|067|S|effects. You may report side effects to Health Canada at||
8139|068|S|1-866-234-2345.||
8139|069|B|||
8139|070|P|PRECAUTIONS:  Before taking calcium acetate, tell your doctor or||
8139|071|P|pharmacist if you are allergic to it; or if you have any other||
8139|072|P|allergies. This product may contain inactive ingredients, which||
8139|073|P|can cause allergic reactions or other problems. Talk to your||
8139|074|P|pharmacist for more details.||
8139|075|P|   Before using this medication, tell your doctor or pharmacist||
8139|076|P|your medical history, especially of: a high blood calcium level||
8139|077|P|(hypercalcemia).||
8139|078|P|   Before having surgery, tell your doctor or dentist about all||
8139|079|P|the products you use (including prescription drugs,||
8139|080|P|nonprescription drugs, and herbal products).||
8139|081|P|   During pregnancy, this medication should be used only when||
8139|082|P|clearly needed. Discuss the risks and benefits with your doctor.||
8139|083|P|   This medication passes into breast milk but is unlikely to||
8139|084|P|harm a nursing infant. Consult your doctor before breastfeeding.||
8139|085|B|||
8139|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8139|087|I|medications work or increase your risk for serious side effects.||
8139|088|I|This document does not contain all possible drug interactions.||
8139|089|I|Keep a list of all the products you use (including||
8139|090|I|prescription/nonprescription drugs and herbal products) and share||
8139|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
8139|092|I|the dosage of any medicines without your doctor's approval.||
8139|093|I|   This product can decrease the absorption of certain drugs,||
8139|094|I|especially if you take them around the same time. These drugs||
8139|095|I|include bisphosphonates (such as alendronate), penicillamine,||
8139|096|I|quinolone antibiotics (such as ciprofloxacin, levofloxacin),||
8139|097|I|tetracycline antibiotics (such as doxycycline, minocycline),||
8139|098|I|thyroid medications (such as levothyroxine), among others. Ask||
8139|099|I|your doctor or pharmacist how long you should wait between doses||
8139|100|I|of this product and your other medications and to find a dosing||
8139|101|I|schedule that works for all your medications.||
8139|102|B|||
8139|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8139|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8139|105|O|poison control center right away. US residents can call||
8139|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8139|107|O|Symptoms of overdose may include nausea, vomiting, loss of||
8139|108|O|appetite, confusion, loss of consciousness.||
8139|109|B|||
8139|110|N|NOTES:  Your doctor may direct you to follow a special diet to||
8139|111|N|help lower your blood phosphate levels. Follow the diet closely.||
8139|112|N|   Lab and/or medical tests (such as blood phosphate and calcium||
8139|113|N|levels) should be done while you are taking this medication. Keep||
8139|114|N|all medical and lab appointments. Consult your doctor for more||
8139|115|N|details.||
8139|116|B|||
8139|117|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
8139|118|D|if you have just eaten. If you have not recently eaten or if it||
8139|119|D|is near the time of the next dose, skip the missed dose. Take||
8139|120|D|your next dose at the regular time. Do not double the dose to||
8139|121|D|catch up.||
8139|122|B|||
8139|123|R|STORAGE:  Store at room temperature away from light and moisture.||
8139|124|R|Do not store in the bathroom. Keep all medications away from||
8139|125|R|children and pets.||
8139|126|R|   Do not flush medications down the toilet or pour them into a||
8139|127|R|drain unless instructed to do so. Properly discard this product||
8139|128|R|when it is expired or no longer needed. Consult your pharmacist||
8139|129|R|or local waste disposal company.||
8139|130|B|||
8139|131|A|Information last revised October 2025.||
8139|132|A|Copyright(c) 2025 First Databank, Inc.||
8139|133|B|||
8141|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8141|002|Z|does NOT have all possible information about this product. This||
8141|003|Z|information does not assure that this product is safe, effective,||
8141|004|Z|or appropriate for you. This information is not individual||
8141|005|Z|medical advice and does not substitute for the advice of your||
8141|006|Z|health care professional. Always ask your health care||
8141|007|Z|professional for complete information about this product and your||
8141|008|Z|specific health needs.||
8141|009|B|||
8141|010|T|AMIKACIN - INJECTION||
8141|011|F|(AM-i-KAY-sin)||
8141|012|B|||
8141|013|C|COMMON BRAND NAME(S): Amikin||
8141|014|B|||
8141|015|W|WARNING:  This medication can cause serious kidney problems and||
8141|016|W|nerve damage, resulting in permanent hearing loss (including||
8141|017|W|deafness or decreased hearing) and balance problems. The risk is||
8141|018|W|increased if you are older, already have kidney disease, or if||
8141|019|W|you have a severe loss of body water (dehydration). Your risk is||
8141|020|W|also increased if you receive high doses, or with longer use of||
8141|021|W|this medication.||
8141|022|W|   Tell your doctor right away if you notice ringing/roaring||
8141|023|W|sounds in the ears, hearing loss, dizziness, or an unusual||
8141|024|W|decrease in the amount of your urine.||
8141|025|W|   Careful monitoring by your doctor will reduce the risk of||
8141|026|W|these side effects. Monitoring may include hearing, kidney,||
8141|027|W|urine, and drug blood level tests.||
8141|028|W|   Avoid other medications that may increase your risk for these||
8141|029|W|serious side effects if taken together with amikacin. See also||
8141|030|W|Drug Interactions section.||
8141|031|B|||
8141|032|U|USES:  This medication is used to prevent or treat a wide variety||
8141|033|U|of bacterial infections. Amikacin belongs to a class of drugs||
8141|034|U|known as aminoglycoside antibiotics. It works by stopping the||
8141|035|U|growth of bacteria.||
8141|036|B|||
8141|037|H|HOW TO USE:  This medication is given by injection into a vein or||
8141|038|H|muscle. It is given as directed by your doctor, usually every 8||
8141|039|H|hours. The dosage is based on your medical condition, weight, lab||
8141|040|H|tests, and response to treatment.||
8141|041|H|   If you are giving this medication to yourself at home, learn||
8141|042|H|all preparation and usage instructions from your health care||
8141|043|H|professional. Before using, check this product for particles or||
8141|044|H|discoloration. If either is present, do not use the liquid. Learn||
8141|045|H|how to store and discard medical supplies safely.||
8141|046|H|   For the best effect, use this antibiotic at evenly spaced||
8141|047|H|times. To help you remember, use this medication at the same||
8141|048|H|time(s) every day.||
8141|049|H|   Continue to use this medication until the full prescribed||
8141|050|H|amount is finished, even if symptoms disappear after a few days.||
8141|051|H|Stopping the medication too early may result in a return of the||
8141|052|H|infection.||
8141|053|H|   Tell your doctor if your condition lasts or gets worse.||
8141|054|B|||
8141|055|S|SIDE EFFECTS:  See also Warning section.||
8141|056|S|   Nausea, vomiting, stomach upset, or loss of appetite may||
8141|057|S|occur. Pain/irritation/redness at the injection site may rarely||
8141|058|S|occur. If any of these effects last or get worse, tell your||
8141|059|S|doctor or pharmacist promptly.||
8141|060|S|   Remember that this medication has been prescribed because your||
8141|061|S|doctor has judged that the benefit to you is greater than the||
8141|062|S|risk of side effects. Many people using this medication do not||
8141|063|S|have serious side effects.||
8141|064|S|   Tell your doctor right away if you have any serious side||
8141|065|S|effects, including: numbness/tingling, muscle twitching or||
8141|066|S|weakness, seizure.||
8141|067|S|   This medication may rarely cause a severe intestinal condition||
8141|068|S|due to a bacteria called C. difficile. This condition may occur||
8141|069|S|during treatment or weeks to months after treatment has stopped.||
8141|070|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8141|071|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8141|072|S|stool.||
8141|073|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8141|074|S|products because they may make symptoms worse.||
8141|075|S|   Use of this medication for prolonged or repeated periods may||
8141|076|S|result in oral thrush or a new yeast infection. Contact your||
8141|077|S|doctor if you notice white patches in your mouth, a change in||
8141|078|S|vaginal discharge, or other new symptoms.||
8141|079|S|   A very serious allergic reaction to this drug is rare.||
8141|080|S|However, get medical help right away if you notice any symptoms||
8141|081|S|of a serious allergic reaction, including: rash, itching/swelling||
8141|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8141|083|S|breathing.||
8141|084|S|   This is not a complete list of possible side effects. If you||
8141|085|S|notice other effects not listed above, contact your doctor or||
8141|086|S|pharmacist.||
8141|087|S|   In the US -||
8141|088|S|   Call your doctor for medical advice about side effects. You||
8141|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8141|090|S|www.fda.gov/medwatch.||
8141|091|S|   In Canada - Call your doctor for medical advice about side||
8141|092|S|effects. You may report side effects to Health Canada at||
8141|093|S|1-866-234-2345.||
8141|094|B|||
8141|095|P|PRECAUTIONS:  Before using amikacin, tell your doctor or||
8141|096|P|pharmacist if you are allergic to it; or to other aminoglycoside||
8141|097|P|antibiotics (such as gentamicin, tobramycin); or if you have any||
8141|098|P|other allergies. This product may contain inactive ingredients||
8141|099|P|(such as sulfites), which can cause allergic reactions or other||
8141|100|P|problems. Talk to your pharmacist for more details.||
8141|101|P|   Before using this medication, tell your doctor or pharmacist||
8141|102|P|your medical history, especially of: cystic fibrosis, hearing||
8141|103|P|problems (including deafness, decreased hearing), kidney||
8141|104|P|problems, low blood minerals (including potassium, magnesium,||
8141|105|P|calcium), myasthenia gravis, Parkinson's disease.||
8141|106|P|   Amikacin may cause live bacterial vaccines (such as typhoid||
8141|107|P|vaccine) to not work well. Tell your health care professional||
8141|108|P|that you are using amikacin before having any||
8141|109|P|immunizations/vaccinations.||
8141|110|P|   Before having surgery, tell your doctor or dentist about all||
8141|111|P|the products you use (including prescription drugs,||
8141|112|P|nonprescription drugs, and herbal products).||
8141|113|P|   Older adults may be more sensitive to the effects of this||
8141|114|P|drug, especially kidney damage.||
8141|115|P|   This medication is not recommended for use during pregnancy.||
8141|116|P|Although there have been reports of harm in babies born to women||
8141|117|P|using similar drugs, there have not been reports of harm in||
8141|118|P|babies born to women using amikacin. Discuss the risks and||
8141|119|P|benefits with your doctor.||
8141|120|P|   This drug passes into breast milk in small amounts. However,||
8141|121|P|many doctors consider breastfeeding safe while using this||
8141|122|P|medication. Consult your doctor before breastfeeding.||
8141|123|B|||
8141|124|I|DRUG INTERACTIONS:  See also Warning section.||
8141|125|I|   Drug interactions may change how your medications work or||
8141|126|I|increase your risk for serious side effects. This document does||
8141|127|I|not contain all possible drug interactions. Keep a list of all||
8141|128|I|the products you use (including prescription/nonprescription||
8141|129|I|drugs and herbal products) and share it with your doctor and||
8141|130|I|pharmacist. Do not start, stop, or change the dosage of any||
8141|131|I|medicines without your doctor's approval.||
8141|132|I|   Other medications that may affect the kidneys or hearing may||
8141|133|I|increase the risk of kidney damage or hearing loss if taken with||
8141|134|I|amikacin. Some examples include: amphotericin B, cidofovir,||
8141|135|I|cisplatin, polymyxin B, tobramycin, cephalosporins such as||
8141|136|I|cephaloridine, nonsteroidal anti-inflammatory drugs (NSAIDs) such||
8141|137|I|as ibuprofen, among others.||
8141|138|B|||
8141|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8141|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8141|141|O|poison control center right away. US residents can call||
8141|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8141|143|B|||
8141|144|N|NOTES:  Lab and/or medical tests (such as kidney function,||
8141|145|N|amikacin blood levels) may be done while you are using this||
8141|146|N|medication. Keep all medical and lab appointments. Consult your||
8141|147|N|doctor for more details.||
8141|148|B|||
8141|149|D|MISSED DOSE:  It is important to get each dose of this medication||
8141|150|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8141|151|D|right away for a new dosing schedule. Do not double the dose to||
8141|152|D|catch up.||
8141|153|B|||
8141|154|R|STORAGE:  Consult the product instructions and your pharmacist||
8141|155|R|for storage details. Keep all medications away from children and||
8141|156|R|pets.||
8141|157|R|   Do not flush medications down the toilet or pour them into a||
8141|158|R|drain unless instructed to do so. Properly discard this product||
8141|159|R|when it is expired or no longer needed. Consult your pharmacist||
8141|160|R|or local waste disposal company.||
8141|161|B|||
8141|162|A|Information last revised November 2024.||
8141|163|A|Copyright(c) 2025 First Databank, Inc.||
8141|164|B|||
8142|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8142|002|Z|does NOT have all possible information about this product. This||
8142|003|Z|information does not assure that this product is safe, effective,||
8142|004|Z|or appropriate for you. This information is not individual||
8142|005|Z|medical advice and does not substitute for the advice of your||
8142|006|Z|health care professional. Always ask your health care||
8142|007|Z|professional for complete information about this product and your||
8142|008|Z|specific health needs.||
8142|009|B|||
8142|010|T|PANCRELIPASE ENTERIC-COATED CAPSULE - ORAL||
8142|011|F|(PAN-kree-LYE-pase)||
8142|012|B|||
8142|013|C|COMMON BRAND NAME(S): Creon, Ultrase, Zenpep, Zymase||
8142|014|B|||
8142|015|U|USES:  This medication contains digestive enzymes to help break||
8142|016|U|down and digest fats, starch, and proteins in food. It is used in||
8142|017|U|conditions where the pancreas cannot make or does not release||
8142|018|U|enough digestive enzymes into the small intestines to digest the||
8142|019|U|food (conditions such as chronic pancreatitis, cystic fibrosis,||
8142|020|U|cancer of the pancreas, post-pancreatectomy,||
8142|021|U|post-gastrointestinal bypass surgery).||
8142|022|B|||
8142|023|H|HOW TO USE:  Some brands of this medication have a Medication||
8142|024|H|Guide provided by your pharmacist. If one is available, read the||
8142|025|H|Medication Guide before your start taking this medication and||
8142|026|H|each time you get a refill. If you have any questions, consult||
8142|027|H|your doctor or pharmacist.||
8142|028|H|   Take this medication by mouth with meals and snacks as||
8142|029|H|directed by your doctor. Swallow the capsule whole. Do not crush||
8142|030|H|or chew the capsules or keep the capsules in your mouth. Doing so||
8142|031|H|can irritate the mouth and also change the way the medication||
8142|032|H|works. Drink plenty of fluids while taking this medication unless||
8142|033|H|your doctor tells you otherwise.||
8142|034|H|   If swallowing is difficult, then the capsule may be opened and||
8142|035|H|the contents mixed in a small amount of liquid or soft food that||
8142|036|H|does not need to be chewed (such as room-temperature applesauce).||
8142|037|H|Do not mix the contents of the capsule with alkaline food or||
8142|038|H|liquid (such as milk, ice cream, tea). Consult your doctor or||
8142|039|H|pharmacist for more information about what foods/liquids (such as||
8142|040|H|infant formula, breast milk) to avoid when mixing. Swallow the||
8142|041|H|food or liquid right away, making sure not to chew the||
8142|042|H|medication. Drink a glass of water or juice after swallowing the||
8142|043|H|food to make sure all the medication is swallowed. Do not save||
8142|044|H|the medication mixture for later.||
8142|045|H|   The dosage is based on your medical condition, diet, weight,||
8142|046|H|and response to treatment. Do not take more capsules in a day||
8142|047|H|than prescribed by your doctor. Your condition will not improve||
8142|048|H|any faster, and your risk of side effects will increase.||
8142|049|H|   Use this medication regularly to get the most benefit from it.||
8142|050|H|Take it with every meal or snack.||
8142|051|H|   If your doctor has recommended that you follow a special diet,||
8142|052|H|it is very important to follow the diet to get the most benefit||
8142|053|H|from this medication.||
8142|054|H|   Do not change brands or dosage forms of pancrelipase without||
8142|055|H|consulting your doctor or pharmacist. Different products may||
8142|056|H|contain different amounts of the digestive enzymes.||
8142|057|H|   Tell your doctor if your condition lasts or gets worse.||
8142|058|B|||
8142|059|S|SIDE EFFECTS:  Diarrhea, constipation, headache, abdominal||
8142|060|S|pain/cramps/bloating, gas, cough, nausea, or vomiting may occur.||
8142|061|S|If any of these effects last or get worse, tell your doctor or||
8142|062|S|pharmacist promptly.||
8142|063|S|   Remember that this medication has been prescribed because your||
8142|064|S|doctor has judged that the benefit to you is greater than the||
8142|065|S|risk of side effects. Many people using this medication do not||
8142|066|S|have serious side effects.||
8142|067|S|   Tell your doctor right away if you have any serious side||
8142|068|S|effects, including: severe constipation, severe stomach/abdominal||
8142|069|S|discomfort, frequent/painful urination, joint pain.||
8142|070|S|   A very serious allergic reaction to this drug is rare.||
8142|071|S|However, get medical help right away if you notice any symptoms||
8142|072|S|of a serious allergic reaction, including: rash, itching/swelling||
8142|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8142|074|S|breathing.||
8142|075|S|   This is not a complete list of possible side effects. If you||
8142|076|S|notice other effects not listed above, contact your doctor or||
8142|077|S|pharmacist.||
8142|078|S|   In the US -||
8142|079|S|   Call your doctor for medical advice about side effects. You||
8142|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8142|081|S|www.fda.gov/medwatch.||
8142|082|S|   In Canada - Call your doctor for medical advice about side||
8142|083|S|effects. You may report side effects to Health Canada at||
8142|084|S|1-866-234-2345.||
8142|085|B|||
8142|086|P|PRECAUTIONS:  Before taking pancrelipase, tell your doctor or||
8142|087|P|pharmacist if you are allergic to it; or to pork protein; or if||
8142|088|P|you have any other allergies. This product may contain inactive||
8142|089|P|ingredients, which can cause allergic reactions or other||
8142|090|P|problems. Talk to your pharmacist for more details.||
8142|091|P|   Before using this medication, tell your doctor or pharmacist||
8142|092|P|your medical history, especially of: sudden/severe swelling of||
8142|093|P|the pancreas (acute pancreatitis), sudden worsening of long-term||
8142|094|P|disease of the pancreas, gout, kidney disease, high uric acid||
8142|095|P|level in the blood (hyperuricemia), intestinal problems (such as||
8142|096|P|blockage).||
8142|097|P|   If you have diabetes, pancrelipase may affect your blood||
8142|098|P|sugar. Check your blood sugar regularly as directed and share the||
8142|099|P|results with your doctor. Your doctor may need to adjust your||
8142|100|P|diabetes medication, exercise program, or diet.||
8142|101|P|   Before having surgery, tell your doctor or dentist about all||
8142|102|P|the products you use (including prescription drugs,||
8142|103|P|nonprescription drugs, and herbal products).||
8142|104|P|   During pregnancy, this medication should be used only when||
8142|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
8142|106|P|   It is unknown if this drug passes into breast milk. Consult||
8142|107|P|your doctor before breastfeeding.||
8142|108|B|||
8142|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8142|110|I|medications work or increase your risk for serious side effects.||
8142|111|I|This document does not contain all possible drug interactions.||
8142|112|I|Keep a list of all the products you use (including||
8142|113|I|prescription/nonprescription drugs and herbal products) and share||
8142|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
8142|115|I|the dosage of any medicines without your doctor's approval.||
8142|116|I|   Some products that may interact with this drug include:||
8142|117|I|acarbose, miglitol.||
8142|118|B|||
8142|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8142|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8142|121|O|poison control center right away. US residents can call||
8142|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8142|123|B|||
8142|124|N|NOTES:  Do not share this product with others.||
8142|125|B|||
8142|126|D|MISSED DOSE:  If you miss a dose, take the next dose with your||
8142|127|D|next meal or snack as directed. Do not double the dose to catch||
8142|128|D|up.||
8142|129|B|||
8142|130|R|STORAGE:  Store at room temperature away from light and moisture.||
8142|131|R|Check the product package for more details on how to store your||
8142|132|R|brand, or ask your pharmacist. Do not store in the bathroom. Keep||
8142|133|R|all medications away from children and pets.||
8142|134|R|   Do not flush medications down the toilet or pour them into a||
8142|135|R|drain unless instructed to do so. Properly discard this product||
8142|136|R|when it is expired or no longer needed. Consult your pharmacist||
8142|137|R|or local waste disposal company.||
8142|138|B|||
8142|139|A|Information last revised May 2024.||
8142|140|A|Copyright(c) 2025 First Databank, Inc.||
8142|141|B|||
8146|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8146|002|Z|does NOT have all possible information about this product. This||
8146|003|Z|information does not assure that this product is safe, effective,||
8146|004|Z|or appropriate for you. This information is not individual||
8146|005|Z|medical advice and does not substitute for the advice of your||
8146|006|Z|health care professional. Always ask your health care||
8146|007|Z|professional for complete information about this product and your||
8146|008|Z|specific health needs.||
8146|009|B|||
8146|010|T|MESALAMINE (5-AMINOSALICYLIC ACID) SUPPOSITORY - RECTAL||
8146|011|F|(me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id)||
8146|012|B|||
8146|013|C|COMMON BRAND NAME(S): Canasa, Rowasa||
8146|014|B|||
8146|015|U|USES:  Mesalamine (also known as 5-aminosalicylic acid) is used||
8146|016|U|to treat ulcerative proctitis, a type of bowel disease. It does||
8146|017|U|not cure ulcerative proctitis, but it may decrease the number of||
8146|018|U|stools, the amount of mucus/blood in the stools, and the rectal||
8146|019|U|bleeding caused by irritation/swelling of the colon/rectum.||
8146|020|U|Mesalamine is an aminosalicylate anti-inflammatory drug. It is||
8146|021|U|believed to work by blocking the production of certain natural||
8146|022|U|chemicals that may cause pain and swelling.||
8146|023|B|||
8146|024|V|OTHER USES:  This section contains uses of this drug that are not||
8146|025|V|listed in the approved professional labeling for the drug but||
8146|026|V|that may be prescribed by your health care professional. Use this||
8146|027|V|drug for a condition that is listed in this section only if it||
8146|028|V|has been so prescribed by your health care professional.||
8146|029|V|   This drug may also be used for Crohn's disease.||
8146|030|B|||
8146|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8146|032|H|from your pharmacist before you start using mesalamine and each||
8146|033|H|time you get a refill. If you have any questions, ask your doctor||
8146|034|H|or pharmacist.||
8146|035|H|   Use this medication rectally as directed by your doctor. If||
8146|036|H|you are using the 1000-milligram strength product, it is usually||
8146|037|H|used once daily at bedtime. If you are using a lower strength||
8146|038|H|product, it is usually used 1 to 3 times daily. Follow your||
8146|039|H|doctor's directions carefully. The dosage is based on your||
8146|040|H|medical condition, response to treatment, and the strength of||
8146|041|H|your prescription.||
8146|042|H|   Drink plenty of fluids during treatment with this medication||
8146|043|H|unless otherwise directed by your doctor. This will help prevent||
8146|044|H|kidney stones.||
8146|045|H|   This medication works best if you have a bowel movement before||
8146|046|H|using it. Wash your hands before and after using the medication.||
8146|047|H|Unwrap the suppository right before using. Try to handle it as||
8146|048|H|little as possible because heat from your fingers may cause it to||
8146|049|H|melt. Lie down on your left side with right knee bent. Gently||
8146|050|H|insert the suppository, pointed end first, into the rectum with||
8146|051|H|your finger. Use a small amount of lubricating gel on the tip of||
8146|052|H|the suppository if desired. Remain lying down for a few minutes.||
8146|053|H|Try to avoid having a bowel movement for 1 to 3 hours, keeping||
8146|054|H|the suppository in place so the medicine can work.||
8146|055|H|   This medication may stain surfaces that it touches (such as||
8146|056|H|clothing, floor, and counter surfaces).||
8146|057|H|   Use this medication regularly in order to get the most benefit||
8146|058|H|from it. To help you remember, use it at the same time(s) each||
8146|059|H|day.||
8146|060|H|   Tell your doctor if your condition lasts or gets worse.||
8146|061|B|||
8146|062|S|SIDE EFFECTS:  Rectal pain, pain when inserting the suppository,||
8146|063|S|headache, gas, stomach pain, and diarrhea may occur. If any of||
8146|064|S|these effects last or get worse, tell your doctor or pharmacist||
8146|065|S|promptly.||
8146|066|S|   Remember that this medication has been prescribed because your||
8146|067|S|doctor has judged that the benefit to you is greater than the||
8146|068|S|risk of side effects. Many people using this medication do not||
8146|069|S|have serious side effects.||
8146|070|S|   Rarely, this medication may make symptoms of your condition||
8146|071|S|worse rather than better (acute intolerance syndrome or||
8146|072|S|sensitivity reaction). Tell your doctor right away if you||
8146|073|S|experience any of these unlikely but serious side effects:||
8146|074|S|worsening stomach pain/cramping, worsening bloody diarrhea,||
8146|075|S|severe/prolonged headache.||
8146|076|S|   Tell your doctor right away if you have any serious side||
8146|077|S|effects, including: chest pain, shortness of breath, severe||
8146|078|S|stomach/abdominal pain (especially if spreading to the back),||
8146|079|S|yellowing eyes/skin, dark urine, signs of kidney problems (such||
8146|080|S|as change in the amount of urine, blood in the urine).||
8146|081|S|   A very serious allergic reaction to this drug is rare.||
8146|082|S|However, get medical help right away if you notice any symptoms||
8146|083|S|of a serious allergic reaction, including: fever, swollen lymph||
8146|084|S|nodes, rash, itching/swelling (especially of the||
8146|085|S|face/tongue/throat), severe dizziness, trouble breathing.||
8146|086|S|   This is not a complete list of possible side effects. If you||
8146|087|S|notice other effects not listed above, contact your doctor or||
8146|088|S|pharmacist.||
8146|089|S|   In the US -||
8146|090|S|   Call your doctor for medical advice about side effects. You||
8146|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8146|092|S|www.fda.gov/medwatch.||
8146|093|S|   In Canada - Call your doctor for medical advice about side||
8146|094|S|effects. You may report side effects to Health Canada at||
8146|095|S|1-866-234-2345.||
8146|096|B|||
8146|097|P|PRECAUTIONS:  Before using mesalamine, tell your doctor or||
8146|098|P|pharmacist if you are allergic to it; or to other||
8146|099|P|aminosalicylates (such as balsalazide, olsalazine); or to||
8146|100|P|salicylates (such as aspirin, salsalate); or to sulfasalazine; or||
8146|101|P|if you have any other allergies. This product may contain||
8146|102|P|inactive ingredients, which can cause allergic reactions or other||
8146|103|P|problems. Talk to your pharmacist for more details.||
8146|104|P|   Before using this medication, tell your doctor or pharmacist||
8146|105|P|your medical history, especially of: kidney problems, liver||
8146|106|P|disease, pancreas problems (pancreatitis), inflammation of the||
8146|107|P|sac around the heart (pericarditis).||
8146|108|P|   This medication may make you more sensitive to the sun,||
8146|109|P|especially if you have skin problems (such as atopic dermatitis,||
8146|110|P|eczema). Limit your time in the sun. Avoid tanning booths and||
8146|111|P|sunlamps. Use sunscreen and wear protective clothing when||
8146|112|P|outdoors. Tell your doctor right away if you get sunburned or||
8146|113|P|have skin blisters/redness.||
8146|114|P|   Before having surgery, tell your doctor or dentist about all||
8146|115|P|the products you use (including prescription drugs,||
8146|116|P|nonprescription drugs, and herbal products).||
8146|117|P|   This medication is similar to aspirin. Children and teenagers||
8146|118|P|younger than 18 years should not take aspirin or aspirin-related||
8146|119|P|medications (such as salicylates) if they have chickenpox, flu,||
8146|120|P|or any undiagnosed illness, or if they have just been given a||
8146|121|P|live virus vaccine (such as varicella vaccine), without first||
8146|122|P|consulting a doctor about Reye's syndrome, a rare but serious||
8146|123|P|illness.||
8146|124|P|   During pregnancy, this medication should be used only when||
8146|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
8146|126|P|   This medication passes into breast milk and may have||
8146|127|P|undesirable effects on a nursing infant. Consult your doctor||
8146|128|P|before breastfeeding.||
8146|129|B|||
8146|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8146|131|I|medications work or increase your risk for serious side effects.||
8146|132|I|This document does not contain all possible drug interactions.||
8146|133|I|Keep a list of all the products you use (including||
8146|134|I|prescription/nonprescription drugs and herbal products) and share||
8146|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
8146|136|I|the dosage of any medicines without your doctor's approval.||
8146|137|I|   This medication may interfere with certain lab tests (such as||
8146|138|I|urine normetanephrine levels), possibly causing false test||
8146|139|I|results. Make sure lab personnel and all your doctors know you||
8146|140|I|use this drug.||
8146|141|B|||
8146|142|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8146|143|O|has overdosed and has serious symptoms such as passing out or||
8146|144|O|trouble breathing, call 911. Otherwise, call a poison control||
8146|145|O|center right away. US residents can call 1-800-222-1222. Canada||
8146|146|O|residents can call 1-844-764-7669.||
8146|147|B|||
8146|148|N|NOTES:  Do not share this medication with others.||
8146|149|N|   Lab and/or medical tests (such as liver/kidney function) may||
8146|150|N|be done before you start using this medication and while you are||
8146|151|N|using it. Keep all medical and lab appointments. Consult your||
8146|152|N|doctor for more details.||
8146|153|B|||
8146|154|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8146|155|D|If it is near the time of the next dose, skip the missed dose.||
8146|156|D|Use your next dose at the regular time. Do not double the dose to||
8146|157|D|catch up.||
8146|158|B|||
8146|159|R|STORAGE:  Store in the refrigerator or at room temperature away||
8146|160|R|from light, heat, and moisture. Do not freeze. Do not store in||
8146|161|R|the bathroom. Keep all medications away from children and pets.||
8146|162|R|   Do not flush medications down the toilet or pour them into a||
8146|163|R|drain unless instructed to do so. Properly discard this product||
8146|164|R|when it is expired or no longer needed. Consult your pharmacist||
8146|165|R|or local waste disposal company.||
8146|166|B|||
8146|167|A|Information last revised September 2024.||
8146|168|A|Copyright(c) 2025 First Databank, Inc.||
8146|169|B|||
8151|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8151|002|Z|does NOT have all possible information about this product. This||
8151|003|Z|information does not assure that this product is safe, effective,||
8151|004|Z|or appropriate for you. This information is not individual||
8151|005|Z|medical advice and does not substitute for the advice of your||
8151|006|Z|health care professional. Always ask your health care||
8151|007|Z|professional for complete information about this product and your||
8151|008|Z|specific health needs.||
8151|009|B|||
8151|010|T|ERTAPENEM - INJECTION||
8151|011|F|(ER-ta-PEN-em)||
8151|012|B|||
8151|013|C|COMMON BRAND NAME(S): Invanz||
8151|014|B|||
8151|015|U|USES:  Ertapenem is used to prevent and treat a wide variety of||
8151|016|U|bacterial infections. This medication is known as a||
8151|017|U|carbapenem-type antibiotic. It works by stopping the growth of||
8151|018|U|bacteria.||
8151|019|B|||
8151|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8151|021|H|from your pharmacist before you start using ertapenem and each||
8151|022|H|time you get a refill. If you have any questions, ask your doctor||
8151|023|H|or pharmacist.||
8151|024|H|   This medication is given by injection into a muscle or vein as||
8151|025|H|directed by your doctor, usually once or twice daily. If you are||
8151|026|H|using this medication to prevent an infection, it is given by||
8151|027|H|injection into a vein by a health care professional. It is given||
8151|028|H|as directed by your doctor, usually 1 hour before your surgery.||
8151|029|H|   If this medication is given by injection into a muscle, follow||
8151|030|H|the manufacturer's directions for mixing with lidocaine 1 percent||
8151|031|H|solution. Do not use this solution for injection into a vein.||
8151|032|H|   If you are using this medication at home, learn all||
8151|033|H|preparation and usage instructions from your health care||
8151|034|H|professional. Before using, check this product for particles or||
8151|035|H|discoloration. If either is present, do not use the liquid. Learn||
8151|036|H|how to store and discard medical supplies safely.||
8151|037|H|   The dosage is based on your medical condition and response to||
8151|038|H|treatment. Children's dosage is also based on age and weight.||
8151|039|H|   For the best effect, use this antibiotic at evenly spaced||
8151|040|H|times. To help you remember, use this medication at the same||
8151|041|H|time(s) every day.||
8151|042|H|   Continue to use this medication until the full prescribed||
8151|043|H|treatment period is finished, even if symptoms disappear after a||
8151|044|H|few days. Stopping the medication too early may result in a||
8151|045|H|return of the infection.||
8151|046|H|   Tell your doctor if your condition lasts or gets worse.||
8151|047|B|||
8151|048|S|SIDE EFFECTS:  Swelling, redness, pain, or soreness at the||
8151|049|S|injection site may occur. Upset stomach, headache, nausea,||
8151|050|S|vomiting, or diarrhea may also occur. If any of these effects||
8151|051|S|last or get worse, tell your doctor or pharmacist promptly.||
8151|052|S|   Remember that this medication has been prescribed because your||
8151|053|S|doctor has judged that the benefit to you is greater than the||
8151|054|S|risk of side effects. Many people using this medication do not||
8151|055|S|have serious side effects.||
8151|056|S|   Get medical help right away if you have any very serious side||
8151|057|S|effects, such as: seizures, unusual weakness.||
8151|058|S|   This medication may rarely cause a severe intestinal condition||
8151|059|S|due to a bacteria called C. difficile. This condition may occur||
8151|060|S|during treatment or weeks to months after treatment has stopped.||
8151|061|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8151|062|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8151|063|S|stool.||
8151|064|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8151|065|S|products because they may make symptoms worse.||
8151|066|S|   Use of this medication for prolonged or repeated periods may||
8151|067|S|result in oral thrush or a new yeast infection. Contact your||
8151|068|S|doctor if you notice white patches in your mouth, a change in||
8151|069|S|vaginal discharge, or other new symptoms.||
8151|070|S|   A very serious allergic reaction to this drug is rare.||
8151|071|S|However, get medical help right away if you notice any symptoms||
8151|072|S|of a serious allergic reaction, such as: rash, itching/swelling||
8151|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8151|074|S|breathing.||
8151|075|S|   This is not a complete list of possible side effects. If you||
8151|076|S|notice other effects not listed above, contact your doctor or||
8151|077|S|pharmacist.||
8151|078|S|   In the US -||
8151|079|S|   Call your doctor for medical advice about side effects. You||
8151|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8151|081|S|www.fda.gov/medwatch.||
8151|082|S|   In Canada - Call your doctor for medical advice about side||
8151|083|S|effects. You may report side effects to Health Canada at||
8151|084|S|1-866-234-2345.||
8151|085|B|||
8151|086|P|PRECAUTIONS:  Before using ertapenem, tell your doctor or||
8151|087|P|pharmacist if you are allergic to it; or to other carbapenems||
8151|088|P|(such as imipenem); or to penicillins or cephalosporins; or if||
8151|089|P|you have any other allergies. Before getting ertapenem by||
8151|090|P|injection into a muscle, also tell your doctor or pharmacist if||
8151|091|P|you are allergic to any amide-type local anesthetics (such as||
8151|092|P|lidocaine). This product may contain inactive ingredients, which||
8151|093|P|can cause allergic reactions or other problems. Talk to your||
8151|094|P|pharmacist for more details.||
8151|095|P|   Before using this medication, tell your doctor or pharmacist||
8151|096|P|your medical history, especially of: brain disorders (such as||
8151|097|P|seizures, head injury, tumor), kidney disease, stomach/intestinal||
8151|098|P|diseases (such as colitis).||
8151|099|P|   Ertapenem may cause live bacterial vaccines (such as typhoid||
8151|100|P|vaccine) to not work well. Tell your health care professional||
8151|101|P|that you are using ertapenem before having any||
8151|102|P|immunizations/vaccinations.||
8151|103|P|   Before having surgery, tell your doctor or dentist about all||
8151|104|P|the products you use (including prescription drugs,||
8151|105|P|nonprescription drugs, and herbal products).||
8151|106|P|   Tell your doctor if you are pregnant before using this||
8151|107|P|medication.||
8151|108|P|   This medication passes into breast milk. Consult your doctor||
8151|109|P|before breastfeeding.||
8151|110|B|||
8151|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8151|112|I|medications work or increase your risk for serious side effects.||
8151|113|I|This document does not contain all possible drug interactions.||
8151|114|I|Keep a list of all the products you use (including||
8151|115|I|prescription/nonprescription drugs and herbal products) and share||
8151|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
8151|117|I|the dosage of any medicines without your doctor's approval.||
8151|118|I|   Some products that may interact with this drug include:||
8151|119|I|valproic acid and related drugs (such as divalproex sodium,||
8151|120|I|sodium valproate).||
8151|121|B|||
8151|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8151|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8151|124|O|poison control center right away. US residents can call||
8151|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8151|126|B|||
8151|127|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
8151|128|N|kidney function) may be done while you are using this medication.||
8151|129|N|Keep all medical and lab appointments. Consult your doctor for||
8151|130|N|more details.||
8151|131|B|||
8151|132|D|MISSED DOSE:  It is important to get each dose of this medication||
8151|133|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8151|134|D|right away for a new dosing schedule. Do not double the dose to||
8151|135|D|catch up.||
8151|136|B|||
8151|137|R|STORAGE:  Consult the product instructions and your pharmacist||
8151|138|R|for storage details. Keep all medications away from children and||
8151|139|R|pets.||
8151|140|R|   Do not flush medications down the toilet or pour them into a||
8151|141|R|drain unless instructed to do so. Properly discard this product||
8151|142|R|when it is expired or no longer needed. Consult your pharmacist||
8151|143|R|or local waste disposal company.||
8151|144|B|||
8151|145|A|Information last revised January 2025.||
8151|146|A|Copyright(c) 2025 First Databank, Inc.||
8151|147|B|||
8152|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8152|002|Z|does NOT have all possible information about this product. This||
8152|003|Z|information does not assure that this product is safe, effective,||
8152|004|Z|or appropriate for you. This information is not individual||
8152|005|Z|medical advice and does not substitute for the advice of your||
8152|006|Z|health care professional. Always ask your health care||
8152|007|Z|professional for complete information about this product and your||
8152|008|Z|specific health needs.||
8152|009|B|||
8152|010|T|TOLTERODINE - ORAL||
8152|011|F|(tol-TER-oh-deen)||
8152|012|B|||
8152|013|C|COMMON BRAND NAME(S): Detrol||
8152|014|B|||
8152|015|U|USES:  This medication is used to treat an overactive bladder. By||
8152|016|U|relaxing the muscles in the bladder, tolterodine improves your||
8152|017|U|ability to control your urination. It helps to reduce leaking of||
8152|018|U|urine, feelings of needing to urinate right away, and frequent||
8152|019|U|trips to the bathroom. This medication belongs to the class of||
8152|020|U|drugs known as antispasmodics.||
8152|021|B|||
8152|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8152|023|H|from your pharmacist before you start using tolterodine and each||
8152|024|H|time you get a refill. If you have any questions, ask your doctor||
8152|025|H|or pharmacist.||
8152|026|H|   Take this medication by mouth with or without food as directed||
8152|027|H|by your doctor, usually twice a day.||
8152|028|H|   Use this medication regularly to get the most benefit from it.||
8152|029|H|To help you remember, use it at the same times each day. The||
8152|030|H|dosage is based on your medical condition, response to treatment,||
8152|031|H|and other medications you may be taking. Be sure to tell your||
8152|032|H|doctor and pharmacist about all the products you use (including||
8152|033|H|prescription drugs, nonprescription drugs, and herbal products).||
8152|034|H|Ask your doctor or pharmacist for more details.||
8152|035|H|   Do not increase your dose or take this medication more often||
8152|036|H|than directed. Your condition will not improve any faster and||
8152|037|H|your risk of serious side effects may be increased.||
8152|038|H|   Tell your doctor if your condition lasts or gets worse.||
8152|039|B|||
8152|040|S|SIDE EFFECTS:  Dry mouth, dry eyes, headache, constipation,||
8152|041|S|stomach upset/pain, dizziness, drowsiness, tiredness, or blurred||
8152|042|S|vision may occur. If any of these effects last or get worse, tell||
8152|043|S|your doctor or pharmacist promptly.||
8152|044|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
8152|045|S|chips, chew (sugarless) gum, drink water, or use a saliva||
8152|046|S|substitute.||
8152|047|S|   To prevent constipation, eat dietary fiber, drink enough||
8152|048|S|water, and exercise. You may also need to take a laxative. Ask||
8152|049|S|your pharmacist which type of laxative is right for you.||
8152|050|S|   Remember that this medication has been prescribed because your||
8152|051|S|doctor has judged that the benefit to you is greater than the||
8152|052|S|risk of side effects. Many people using this medication do not||
8152|053|S|have serious side effects.||
8152|054|S|   Tell your doctor right away if you have any serious side||
8152|055|S|effects, including: vision changes, severe stomach/abdominal||
8152|056|S|pain, trouble urinating, signs of kidney infection (such as||
8152|057|S|burning/painful urination, lower back pain, fever).||
8152|058|S|   Get medical help right away if you have any very serious side||
8152|059|S|effects, including: fast/slow/irregular heartbeat, severe||
8152|060|S|dizziness, fainting.||
8152|061|S|   A very serious allergic reaction to this drug is rare.||
8152|062|S|However, get medical help right away if you notice any symptoms||
8152|063|S|of a serious allergic reaction, including: rash, itching/swelling||
8152|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8152|065|S|breathing.||
8152|066|S|   This is not a complete list of possible side effects. If you||
8152|067|S|notice other effects not listed above, contact your doctor or||
8152|068|S|pharmacist.||
8152|069|S|   In the US -||
8152|070|S|   Call your doctor for medical advice about side effects. You||
8152|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8152|072|S|www.fda.gov/medwatch.||
8152|073|S|   In Canada - Call your doctor for medical advice about side||
8152|074|S|effects. You may report side effects to Health Canada at||
8152|075|S|1-866-234-2345.||
8152|076|B|||
8152|077|P|PRECAUTIONS:  Before taking tolterodine, tell your doctor or||
8152|078|P|pharmacist if you are allergic to it; or to fesoterodine; or if||
8152|079|P|you have any other allergies. This product may contain inactive||
8152|080|P|ingredients, which can cause allergic reactions or other||
8152|081|P|problems. Talk to your pharmacist for more details.||
8152|082|P|   Before using this medication, tell your doctor or pharmacist||
8152|083|P|your medical history, especially of: problems emptying your||
8152|084|P|bladder (urinary retention, bladder outflow obstruction), severe||
8152|085|P|blockage of stomach/intestines (gastric retention), glaucoma,||
8152|086|P|stomach/intestinal disease (such as ulcerative colitis, slowed||
8152|087|P|movement of stomach/intestines), severe constipation, kidney||
8152|088|P|disease, liver disease, a certain muscle disease (myasthenia||
8152|089|P|gravis).||
8152|090|P|   Tolterodine may cause a condition that affects the heart||
8152|091|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8152|092|P|serious (rarely fatal) fast/irregular heartbeat and other||
8152|093|P|symptoms (such as severe dizziness, fainting) that need medical||
8152|094|P|attention right away.||
8152|095|P|   The risk of QT prolongation may be increased if you have||
8152|096|P|certain medical conditions or are taking other drugs that may||
8152|097|P|cause QT prolongation. Before using tolterodine, tell your doctor||
8152|098|P|or pharmacist of all the drugs you take and if you have any of||
8152|099|P|the following conditions: certain heart problems (heart failure,||
8152|100|P|slow heartbeat, QT prolongation in the EKG), family history of||
8152|101|P|certain heart problems (QT prolongation in the EKG, sudden||
8152|102|P|cardiac death).||
8152|103|P|   Low levels of potassium or magnesium in the blood may also||
8152|104|P|increase your risk of QT prolongation. This risk may increase if||
8152|105|P|you use certain drugs (such as diuretics/"water pills") or if you||
8152|106|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8152|107|P|Talk to your doctor about using tolterodine safely.||
8152|108|P|   This drug may make you dizzy or drowsy or blur your vision.||
8152|109|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8152|110|P|drowsy. Do not drive, use machinery, or do anything that needs||
8152|111|P|alertness or clear vision until you can do it safely. Limit||
8152|112|P|alcoholic beverages. Talk to your doctor if you are using||
8152|113|P|marijuana (cannabis).||
8152|114|P|   This medication may make you sweat less, making you more||
8152|115|P|likely to get heat stroke. Avoid doing things that may cause you||
8152|116|P|to overheat, such as hard work or exercise in hot weather, or||
8152|117|P|using hot tubs. When the weather is hot, drink a lot of fluids||
8152|118|P|and dress lightly. If you overheat, quickly look for a place to||
8152|119|P|cool down and rest. Get medical help right away if you have a||
8152|120|P|fever that does not go away, mental/mood changes, headache, or||
8152|121|P|dizziness.||
8152|122|P|   Before having surgery, tell your doctor or dentist about all||
8152|123|P|the products you use (including prescription drugs,||
8152|124|P|nonprescription drugs, and herbal products).||
8152|125|P|   Older adults may be more sensitive to the side effects of this||
8152|126|P|drug, especially QT prolongation (see above), drowsiness,||
8152|127|P|confusion, constipation, or trouble urinating. Drowsiness and||
8152|128|P|confusion can increase the risk of falling.||
8152|129|P|   During pregnancy, this medication should be used only when||
8152|130|P|clearly needed. Discuss the risks and benefits with your doctor.||
8152|131|P|   It is unknown if this drug passes into breast milk. Consult||
8152|132|P|your doctor before breastfeeding.||
8152|133|B|||
8152|134|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8152|135|I|medications work or increase your risk for serious side effects.||
8152|136|I|This document does not contain all possible drug interactions.||
8152|137|I|Keep a list of all the products you use (including||
8152|138|I|prescription/nonprescription drugs and herbal products) and share||
8152|139|I|it with your doctor and pharmacist. Do not start, stop, or change||
8152|140|I|the dosage of any medicines without your doctor's approval.||
8152|141|I|   Some products that may interact with this drug include:||
8152|142|I|mifepristone, potassium tablets/capsules, pramlintide.||
8152|143|I|   Many drugs besides tolterodine may affect the heart rhythm (QT||
8152|144|I|prolongation), including amiodarone, dofetilide, pimozide,||
8152|145|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
8152|146|I|erythromycin), among others.||
8152|147|I|   Tell your doctor or pharmacist if you are taking other||
8152|148|I|products that cause drowsiness including alcohol, marijuana||
8152|149|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
8152|150|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
8152|151|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
8152|152|I|codeine).||
8152|153|I|   Check the labels on all your medicines (such as allergy or||
8152|154|I|cough-and-cold products) because they may contain ingredients||
8152|155|I|that cause drowsiness. Ask your pharmacist about using those||
8152|156|I|products safely.||
8152|157|B|||
8152|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8152|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8152|160|O|poison control center right away. US residents can call||
8152|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8152|162|O|Symptoms of overdose may include fast/slow/irregular heartbeat,||
8152|163|O|fainting, unusual excitement, mental/mood changes.||
8152|164|B|||
8152|165|N|NOTES:  Do not share this medication with others.||
8152|166|B|||
8152|167|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8152|168|D|If it is near the time of the next dose, skip the missed dose.||
8152|169|D|Use your next dose at the regular time. Do not double the dose to||
8152|170|D|catch up.||
8152|171|B|||
8152|172|R|STORAGE:  Store at room temperature away from light and moisture.||
8152|173|R|Do not store in the bathroom. Keep all medications away from||
8152|174|R|children and pets.||
8152|175|R|   Do not flush medications down the toilet or pour them into a||
8152|176|R|drain unless instructed to do so. Properly discard this product||
8152|177|R|when it is expired or no longer needed. Consult your pharmacist||
8152|178|R|or local waste disposal company.||
8152|179|B|||
8152|180|A|Information last revised May 2024.||
8152|181|A|Copyright(c) 2025 First Databank, Inc.||
8152|182|B|||
8155|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8155|002|Z|does NOT have all possible information about this product. This||
8155|003|Z|information does not assure that this product is safe, effective,||
8155|004|Z|or appropriate for you. This information is not individual||
8155|005|Z|medical advice and does not substitute for the advice of your||
8155|006|Z|health care professional. Always ask your health care||
8155|007|Z|professional for complete information about this product and your||
8155|008|Z|specific health needs.||
8155|009|B|||
8155|010|T|BUPROPION SUSTAINED-RELEASE (ANTIDEPRESSANT) - ORAL||
8155|011|F|(bue-PROE-pee-on)||
8155|012|B|||
8155|013|C|COMMON BRAND NAME(S): Wellbutrin SR||
8155|014|B|||
8155|015|W|WARNING:  Bupropion is an antidepressant used for smoking||
8155|016|W|cessation and to treat a variety of conditions, including||
8155|017|W|depression and other mental/mood disorders. Antidepressants can||
8155|018|W|help prevent suicidal thoughts/attempts and provide other||
8155|019|W|important benefits. However, a small number of people (especially||
8155|020|W|people younger than 25) who take antidepressants for any||
8155|021|W|condition may experience new or worsening depression, other||
8155|022|W|mental/mood symptoms, or suicidal thoughts/attempts. It is very||
8155|023|W|important to talk with the doctor about the risks and benefits of||
8155|024|W|antidepressant medication, even if treatment is not for a||
8155|025|W|mental/mood condition.||
8155|026|W|   Tell the doctor right away if you notice new or worsening||
8155|027|W|depression/other psychiatric conditions, unusual behavior changes||
8155|028|W|(including possible suicidal thoughts/attempts), or other||
8155|029|W|mental/mood changes (including new/worsening anxiety, panic||
8155|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
8155|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
8155|032|W|especially watchful for these symptoms when a new antidepressant||
8155|033|W|is started or when the dose is changed.||
8155|034|W|   If you are using bupropion to quit smoking and experience any||
8155|035|W|of these symptoms, stop taking it and contact your doctor right||
8155|036|W|away. Also, tell your doctor right away if you have any of these||
8155|037|W|symptoms after stopping treatment with bupropion.||
8155|038|B|||
8155|039|U|USES:  This medication is used to treat depression. Bupropion||
8155|040|U|works by helping to restore the balance of certain natural||
8155|041|U|substances (dopamine, norepinephrine) in the brain.||
8155|042|B|||
8155|043|V|OTHER USES:  This section contains uses of this drug that are not||
8155|044|V|listed in the approved professional labeling for the drug but||
8155|045|V|that may be prescribed by your health care professional. Use this||
8155|046|V|drug for a condition that is listed in this section only if it||
8155|047|V|has been so prescribed by your health care professional.||
8155|048|V|   This drug may also be used for other mental/mood disorders||
8155|049|V|(such as attention deficit hyperactivity disorder-ADHD, seasonal||
8155|050|V|affective disorder, depressive phase of bipolar disorder). It may||
8155|051|V|be used to help people quit smoking by lessening cravings and||
8155|052|V|nicotine withdrawal. It may also be used to for binge eating||
8155|053|V|disorder (BED).||
8155|054|B|||
8155|055|H|HOW TO USE:  Read the Medication Guide provided by your||
8155|056|H|pharmacist before you start using bupropion and each time you get||
8155|057|H|a refill. If you have any questions, ask your doctor or||
8155|058|H|pharmacist.||
8155|059|H|   Take this medication by mouth with or without food as directed||
8155|060|H|by your doctor, usually twice a day. If you have stomach upset,||
8155|061|H|you may take this medication with or after a meal or snack. Take||
8155|062|H|the first dose as soon as you wake up in the morning and the||
8155|063|H|second dose at least 8 hours later, or take as directed by your||
8155|064|H|doctor. Taking this medication late in the day may cause trouble||
8155|065|H|sleeping (insomnia). Take this medication regularly to get the||
8155|066|H|most benefit from it. To help you remember, take it at the same||
8155|067|H|times each day.||
8155|068|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
8155|069|H|Doing so can release all of the drug at once, increasing the risk||
8155|070|H|of side effects.||
8155|071|H|   The dosage is based on your medical condition and response to||
8155|072|H|treatment. To reduce your risk of side effects, your doctor may||
8155|073|H|direct you to start this medication at a low dose and gradually||
8155|074|H|increase your dose. Do not increase your dose or use this drug||
8155|075|H|more often or for longer than prescribed. Your condition will not||
8155|076|H|improve any faster and your risk of side effects will increase.||
8155|077|H|   Do not stop taking this medication without consulting your||
8155|078|H|doctor. Your dose may need to be gradually decreased.||
8155|079|H|   It may take 4 weeks or longer before you get the full benefit||
8155|080|H|of this drug. Tell your doctor if your condition does not get||
8155|081|H|better or if it gets worse.||
8155|082|B|||
8155|083|S|SIDE EFFECTS:  See also Warning section.||
8155|084|S|   Dry mouth, sore throat, dizziness, nausea, vomiting, ringing||
8155|085|S|in the ears, headache, decreased appetite, weight loss,||
8155|086|S|constipation, trouble sleeping, increased sweating, or shaking||
8155|087|S|(tremor) may occur. If any of these effects last or get worse,||
8155|088|S|tell your doctor or pharmacist promptly.||
8155|089|S|   An empty tablet shell may appear in your stool. This effect is||
8155|090|S|harmless because your body has already absorbed the medication.||
8155|091|S|   Remember that this medication has been prescribed because your||
8155|092|S|doctor has judged that the benefit to you is greater than the||
8155|093|S|risk of side effects. Many people using this medication do not||
8155|094|S|have serious side effects.||
8155|095|S|   This medication may raise your blood pressure. Check your||
8155|096|S|blood pressure regularly and tell your doctor if the results are||
8155|097|S|high.||
8155|098|S|   Tell your doctor right away if you have any serious side||
8155|099|S|effects, including: fast/pounding/irregular heartbeat,||
8155|100|S|mental/mood changes (such as anxiety, agitation, confusion,||
8155|101|S|unusual behavior/thinking, memory loss), unusual weight loss or||
8155|102|S|gain.||
8155|103|S|   Get medical help right away if you have any very serious side||
8155|104|S|effects, including: seizure, eye pain/swelling/redness, widened||
8155|105|S|pupils, vision changes (such as seeing rainbows around lights at||
8155|106|S|night, blurred vision).||
8155|107|S|   A very serious allergic reaction to this drug is rare.||
8155|108|S|However, get medical help right away if you notice any symptoms||
8155|109|S|of a serious allergic reaction, including: rash, itching/swelling||
8155|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8155|111|S|breathing.||
8155|112|S|   This is not a complete list of possible side effects. If you||
8155|113|S|notice other effects not listed above, contact your doctor or||
8155|114|S|pharmacist.||
8155|115|S|   In the US -||
8155|116|S|   Call your doctor for medical advice about side effects. You||
8155|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8155|118|S|www.fda.gov/medwatch.||
8155|119|S|   In Canada - Call your doctor for medical advice about side||
8155|120|S|effects. You may report side effects to Health Canada at||
8155|121|S|1-866-234-2345.||
8155|122|B|||
8155|123|P|PRECAUTIONS:  Before taking bupropion, tell your doctor or||
8155|124|P|pharmacist if you are allergic to it; or if you have any other||
8155|125|P|allergies. This product may contain inactive ingredients, which||
8155|126|P|can cause allergic reactions or other problems. Talk to your||
8155|127|P|pharmacist for more details.||
8155|128|P|   Before using this medication, tell your doctor or pharmacist||
8155|129|P|your medical history, especially of: diabetes, heart disease,||
8155|130|P|high blood pressure, kidney problems, liver disease, use/abuse of||
8155|131|P|drugs/alcohol, seizures or conditions that increase your risk of||
8155|132|P|seizures (including brain/head injury, brain tumor, eating||
8155|133|P|disorders such as bulimia/anorexia nervosa), personal or family||
8155|134|P|history of glaucoma (angle-closure type).||
8155|135|P|   This medication should not be used if you are suddenly||
8155|136|P|stopping regular use of sedatives (including benzodiazepines such||
8155|137|P|as lorazepam), drugs used to treat seizures, or alcohol. Doing so||
8155|138|P|may increase your risk of seizures.||
8155|139|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8155|140|P|can make you more dizzy. Do not drive, use machinery, or do||
8155|141|P|anything that needs alertness until you can do it safely. Avoid||
8155|142|P|alcoholic beverages. Talk to your doctor if you are using||
8155|143|P|marijuana (cannabis). Alcohol can also increase your risk of||
8155|144|P|seizures.||
8155|145|P|   Before having surgery, tell your doctor or dentist about all||
8155|146|P|the products you use (including prescription drugs,||
8155|147|P|nonprescription drugs, and herbal products).||
8155|148|P|   Older adults may be more sensitive to the side effects of this||
8155|149|P|drug, especially dizziness and memory loss. Dizziness can||
8155|150|P|increase the risk of falling.||
8155|151|P|   During pregnancy, this medication should be used only when||
8155|152|P|clearly needed. Since untreated mental/mood problems (such as||
8155|153|P|depression, seasonal affective disorder, bipolar disorder) can be||
8155|154|P|a serious condition, do not stop taking this medication unless||
8155|155|P|directed by your doctor. If you are planning pregnancy, become||
8155|156|P|pregnant, or think you may be pregnant, immediately discuss with||
8155|157|P|your doctor the benefits and risks of using this medication||
8155|158|P|during pregnancy.||
8155|159|P|   This drug passes into breast milk and may have undesirable||
8155|160|P|effects on a nursing infant. Consult your doctor before||
8155|161|P|breastfeeding.||
8155|162|B|||
8155|163|I|DRUG INTERACTIONS:  See also Precautions section.||
8155|164|I|   Drug interactions may change how your medications work or||
8155|165|I|increase your risk for serious side effects. This document does||
8155|166|I|not contain all possible drug interactions. Keep a list of all||
8155|167|I|the products you use (including prescription/nonprescription||
8155|168|I|drugs and herbal products) and share it with your doctor and||
8155|169|I|pharmacist. Do not start, stop, or change the dosage of any||
8155|170|I|medicines without your doctor's approval.||
8155|171|I|   Some products that may interact with this drug include:||
8155|172|I|codeine, pimozide, tamoxifen, thioridazine.||
8155|173|I|   Taking MAO inhibitors with this medication may cause a serious||
8155|174|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
8155|175|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8155|176|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8155|177|I|selegiline, tranylcypromine) during treatment with this||
8155|178|I|medication. Most MAO inhibitors should also not be taken for two||
8155|179|I|weeks before and after treatment with this medication. Ask your||
8155|180|I|doctor when to start or stop taking this medication.||
8155|181|I|   This medication may interfere with certain medical/lab tests||
8155|182|I|(such as brain scan for Parkinson's disease, urine screening for||
8155|183|I|amphetamines), possibly causing false test results. Make sure lab||
8155|184|I|personnel and all your doctors know you use this drug.||
8155|185|B|||
8155|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8155|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8155|188|O|poison control center right away. US residents can call||
8155|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8155|190|O|Symptoms of overdose may include: seizures, severe confusion,||
8155|191|O|hallucinations, rapid heart rate, loss of consciousness.||
8155|192|B|||
8155|193|N|NOTES:  Do not share this medication with others.||
8155|194|N|   Lab and/or medical tests (such as blood pressure, liver||
8155|195|N|function) may be done while you are taking this medication. Keep||
8155|196|N|all medical and lab appointments. Consult your doctor for more||
8155|197|N|details.||
8155|198|B|||
8155|199|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
8155|200|D|next dose at the regular time. Do not double the dose to catch||
8155|201|D|up.||
8155|202|B|||
8155|203|R|STORAGE:  Store at room temperature away from light and moisture.||
8155|204|R|You may notice an odor from the tablets; this is normal and does||
8155|205|R|not affect how they work. Do not store in the bathroom. Keep all||
8155|206|R|medications away from children and pets.||
8155|207|R|   Do not flush medications down the toilet or pour them into a||
8155|208|R|drain unless instructed to do so. Properly discard this product||
8155|209|R|when it is expired or no longer needed. Consult your pharmacist||
8155|210|R|or local waste disposal company.||
8155|211|B|||
8155|212|A|Information last revised November 2024.||
8155|213|A|Copyright(c) 2025 First Databank, Inc.||
8155|214|B|||
8157|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8157|002|Z|does NOT have all possible information about this product. This||
8157|003|Z|information does not assure that this product is safe, effective,||
8157|004|Z|or appropriate for you. This information is not individual||
8157|005|Z|medical advice and does not substitute for the advice of your||
8157|006|Z|health care professional. Always ask your health care||
8157|007|Z|professional for complete information about this product and your||
8157|008|Z|specific health needs.||
8157|009|B|||
8157|010|T|HEPATITIS B VACCINE - INJECTION||
8157|011|F|(hep-uh-TIE-tuss B)||
8157|012|B|||
8157|013|C|COMMON BRAND NAME(S): Engerix-B, Recombivax HB||
8157|014|B|||
8157|015|U|USES:  This vaccine is used to help prevent hepatitis B.||
8157|016|U|Hepatitis B infection can cause serious problems including liver||
8157|017|U|failure, long-term hepatitis B infection, cirrhosis, and liver||
8157|018|U|cancer. Vaccination is the best way to protect against this||
8157|019|U|infection. This vaccine works by increasing the body's natural||
8157|020|U|defense (immunity) against the virus.||
8157|021|U|   The vaccine is recommended for people of all ages, especially||
8157|022|U|those at an increased risk of getting the infection. Those at an||
8157|023|U|increased risk include health care personnel, lab workers who||
8157|024|U|handle blood and patient specimens, police, fire and emergency||
8157|025|U|medical personnel who give first aid treatment, hemophiliacs,||
8157|026|U|dialysis patients, people who live with or spend much time with||
8157|027|U|people with long-term hepatitis B infections, people with||
8157|028|U|multiple sex partners, men who have sex with men, sex workers,||
8157|029|U|injection drug abusers, and people traveling to high-risk areas.||
8157|030|U|   Vaccines may not fully protect everyone who receives them.||
8157|031|B|||
8157|032|H|HOW TO USE:  Read all vaccine information available from your||
8157|033|H|health care professional before receiving the vaccine. If you||
8157|034|H|have any questions, ask your health care professional.||
8157|035|H|   This vaccine is given by injection into a muscle by a health||
8157|036|H|care professional. It is given in the upper arm for children and||
8157|037|H|adults and in the thigh for infants. This vaccine may also be||
8157|038|H|given by injection under the skin for people who have a bleeding||
8157|039|H|disorder.||
8157|040|H|   Vaccines are usually given in a series of doses to provide the||
8157|041|H|best protection. Closely follow the vaccination schedule provided||
8157|042|H|by your health care professional. To help you remember, mark your||
8157|043|H|calendar with a reminder.||
8157|044|H|   This vaccine may be given at the same time as other vaccines.||
8157|045|B|||
8157|046|S|SIDE EFFECTS:  Pain/soreness/redness/swelling at the injection||
8157|047|S|site, fever, headache, tiredness, sore throat, nausea, diarrhea,||
8157|048|S|and loss of appetite may occur. If any of these effects last or||
8157|049|S|get worse, tell your health care professional promptly.||
8157|050|S|   Rarely, some people have symptoms such as fainting, dizziness,||
8157|051|S|vision changes, or ringing in the ears just after getting a||
8157|052|S|vaccine injection. Tell your health care professional right away||
8157|053|S|if you have any of these symptoms. Sitting or lying down may||
8157|054|S|help, since these symptoms usually don't last long.||
8157|055|S|   Remember that this vaccine has been prescribed because your||
8157|056|S|health care professional has judged that the benefit to you is||
8157|057|S|greater than the risk of side effects. Many people using this||
8157|058|S|vaccine do not have serious side effects.||
8157|059|S|   A very serious allergic reaction to this vaccine is rare.||
8157|060|S|However, get medical help right away if you notice any symptoms||
8157|061|S|of a serious allergic reaction, including: rash, itching/swelling||
8157|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8157|063|S|breathing.||
8157|064|S|   This is not a complete list of possible side effects. If you||
8157|065|S|notice other effects not listed above, contact your health care||
8157|066|S|professional.||
8157|067|S|   Contact the health care professional for medical advice about||
8157|068|S|side effects. The following numbers do not provide medical||
8157|069|S|advice, but in the US you may report side effects to the Vaccine||
8157|070|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
8157|071|S|Canada, you may call the Vaccine Safety Section at Public Health||
8157|072|S|Agency of Canada at 1-866-844-0018.||
8157|073|B|||
8157|074|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
8157|075|P|care professional if you are allergic to it; or if you have any||
8157|076|P|other allergies. This product may contain inactive ingredients||
8157|077|P|(such as latex rubber or yeast found in some brands), which can||
8157|078|P|cause allergic reactions or other problems. Talk to your health||
8157|079|P|care professional for more details.||
8157|080|P|   Before receiving this vaccine, tell your health care||
8157|081|P|professional your medical history, especially of: current||
8157|082|P|fever/illness, immune system disorders (such as due to HIV||
8157|083|P|infection, certain cancers such as leukemia/lymphoma, cancer or||
8157|084|P|radiation treatment), vaccination history (including previous||
8157|085|P|reactions to any vaccines).||
8157|086|P|   Older adults and people on dialysis may not respond as well to||
8157|087|P|the vaccine. Talk to your health care professional for more||
8157|088|P|details.||
8157|089|P|   During pregnancy, this vaccine should be used only when||
8157|090|P|clearly needed. Discuss the risks and benefits with your health||
8157|091|P|care professional.||
8157|092|P|   It is unknown if this vaccine passes into breast milk. Consult||
8157|093|P|your health care professional before breastfeeding.||
8157|094|B|||
8157|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8157|096|I|medications work or increase your risk for serious side effects.||
8157|097|I|This document does not contain all possible drug interactions.||
8157|098|I|Keep a list of all the products you use (including||
8157|099|I|prescription/nonprescription drugs and herbal products) and share||
8157|100|I|it with your health care professional. Do not start, stop, or||
8157|101|I|change the dosage of any medicines without your doctor's||
8157|102|I|approval.||
8157|103|I|   Some products that may interact with this vaccine are: drugs||
8157|104|I|that weaken the immune system (including cyclosporine,||
8157|105|I|tacrolimus, cancer chemotherapy, corticosteroids such as||
8157|106|I|prednisone).||
8157|107|B|||
8157|108|O|OVERDOSE:  Not applicable.||
8157|109|B|||
8157|110|N|NOTES:  Lab and/or medical tests (such as hepatitis B antibody||
8157|111|N|levels) may be done while you are using this vaccine. Keep all||
8157|112|N|medical and lab appointments. Consult your health care||
8157|113|N|professional for more details.||
8157|114|N|   Keep vaccine records for yourself and your children and||
8157|115|N|provide them to the health care professionals to prevent||
8157|116|N|unnecessary re-vaccinations.||
8157|117|B|||
8157|118|D|MISSED DOSE:  It is important that you get each vaccination as||
8157|119|D|scheduled. Ask when you should get each dose and mark your||
8157|120|D|calendar with a reminder. If you miss a dose, call the health||
8157|121|D|care professional to reschedule.||
8157|122|B|||
8157|123|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
8157|124|R|medications away from children and pets.||
8157|125|R|   Do not flush medications down the toilet or pour them into a||
8157|126|R|drain unless instructed to do so. Properly discard this product||
8157|127|R|when it is expired or no longer needed. Consult your pharmacist||
8157|128|R|or local waste disposal company.||
8157|129|B|||
8157|130|A|Information last revised January 2025.||
8157|131|A|Copyright(c) 2025 First Databank, Inc.||
8157|132|B|||
8162|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8162|002|Z|does NOT have all possible information about this product. This||
8162|003|Z|information does not assure that this product is safe, effective,||
8162|004|Z|or appropriate for you. This information is not individual||
8162|005|Z|medical advice and does not substitute for the advice of your||
8162|006|Z|health care professional. Always ask your health care||
8162|007|Z|professional for complete information about this product and your||
8162|008|Z|specific health needs.||
8162|009|B|||
8162|010|T|TRIPTORELIN 3 MONTH (11.25 MG) - INJECTION||
8162|011|F|(trip-toe-REL-in)||
8162|012|B|||
8162|013|C|COMMON BRAND NAME(S): Trelstar||
8162|014|B|||
8162|015|U|USES:  Triptorelin is used to treat advanced prostate cancer. It||
8162|016|U|is not a cure. Most types of prostate cancer need the hormone||
8162|017|U|testosterone to grow and spread. Triptorelin works by reducing||
8162|018|U|the amount of testosterone that the body makes. This effect helps||
8162|019|U|slow or stop the growth of cancer cells and helps relieve||
8162|020|U|symptoms such as painful/difficult urination. This medication is||
8162|021|U|similar to a natural substance made by the body (luteinizing||
8162|022|U|hormone releasing hormone-LHRH). Talk to your doctor about the||
8162|023|U|risks and benefits of treatment.||
8162|024|B|||
8162|025|V|OTHER USES:  This section contains uses of this drug that are not||
8162|026|V|listed in the approved professional labeling for the drug but||
8162|027|V|that may be prescribed by your health care professional. Use this||
8162|028|V|drug for a condition that is listed in this section only if it||
8162|029|V|has been so prescribed by your health care professional.||
8162|030|V|   This drug may also be used for a certain disorder of the||
8162|031|V|uterus (endometriosis). Triptorelin may also be used to stop||
8162|032|V|early puberty in children.||
8162|033|B|||
8162|034|H|HOW TO USE:  This medication is given as an injection into the||
8162|035|H|muscle of your buttocks by a health care professional. It is||
8162|036|H|given as directed by your doctor, usually once every 3 months (12||
8162|037|H|weeks).||
8162|038|H|   Follow the dosing schedule carefully to get the most benefit||
8162|039|H|from this drug. To help you remember, mark your calendar with a||
8162|040|H|reminder.||
8162|041|H|   During the first few weeks of treatment, your testosterone||
8162|042|H|level will actually increase before it decreases. This is a||
8162|043|H|normal response by your body to this drug. This effect may result||
8162|044|H|in new or worsening symptoms for the first few weeks. If you have||
8162|045|H|prostate cancer that has spread to the spine or that has caused||
8162|046|H|urinary blockage, you may require closer monitoring by your||
8162|047|H|doctor, especially when you first start treatment. Tell your||
8162|048|H|doctor right away if you experience any of the following serious||
8162|049|H|side effects: bone pain, numbness/tingling/weakness of the||
8162|050|H|arms/legs, blood in the urine, painful/difficult urination.||
8162|051|H|   Tell your doctor if your condition does not get better or if||
8162|052|H|it gets worse.||
8162|053|B|||
8162|054|S|SIDE EFFECTS:  See also the How to Use section.||
8162|055|S|   Hot flashes (flushing), decreased sexual interest/ability,||
8162|056|S|shrinking of the testicles, and breast tenderness/swelling may||
8162|057|S|occur as a result of lowered testosterone levels. Dizziness and||
8162|058|S|headache may also occur with this drug. If any of these effects||
8162|059|S|bother you, tell your doctor or pharmacist promptly.||
8162|060|S|   Remember that this medication has been prescribed because your||
8162|061|S|doctor has judged that the benefit to you is greater than the||
8162|062|S|risk of side effects. Many people using this medication do not||
8162|063|S|have serious side effects.||
8162|064|S|   Tell your doctor right away if you have any serious side||
8162|065|S|effects, including: bone/joint/unusual pain, easily broken bones,||
8162|066|S|swelling of the ankles/feet, unusual weakness, inability to move||
8162|067|S|(paralysis), increased thirst, increased urination, mental/mood||
8162|068|S|changes (such as depression), signs of liver disease (such as||
8162|069|S|nausea/vomiting that doesn't stop, loss of appetite,||
8162|070|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
8162|071|S|   Get medical help right away if you have any very serious side||
8162|072|S|effects, including: chest/jaw/left arm pain, fast/irregular||
8162|073|S|heartbeat, severe dizziness, fainting, weakness on one side of||
8162|074|S|the body, trouble speaking, seizures.||
8162|075|S|   A very serious allergic reaction to this drug is rare.||
8162|076|S|However, get medical help right away if you notice any symptoms||
8162|077|S|of a serious allergic reaction, including: fever, swollen lymph||
8162|078|S|nodes, rash, itching/swelling (especially of the||
8162|079|S|face/tongue/throat), severe dizziness, trouble breathing.||
8162|080|S|   This is not a complete list of possible side effects. If you||
8162|081|S|notice other effects not listed above, contact your doctor or||
8162|082|S|pharmacist.||
8162|083|S|   In the US -||
8162|084|S|   Call your doctor for medical advice about side effects. You||
8162|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8162|086|S|www.fda.gov/medwatch.||
8162|087|S|   In Canada - Call your doctor for medical advice about side||
8162|088|S|effects. You may report side effects to Health Canada at||
8162|089|S|1-866-234-2345.||
8162|090|B|||
8162|091|P|PRECAUTIONS:  Before using triptorelin, tell your doctor or||
8162|092|P|pharmacist if you are allergic to it; or to other LHRH-type drugs||
8162|093|P|(such as leuprolide); or if you have any other allergies. This||
8162|094|P|product may contain inactive ingredients, which can cause||
8162|095|P|allergic reactions or other problems. Talk to your pharmacist for||
8162|096|P|more details.||
8162|097|P|   Before using this medication, tell your doctor or pharmacist||
8162|098|P|your medical history, especially of: kidney disease, liver||
8162|099|P|disease, personal or family history of weak/broken bones||
8162|100|P|(osteoporosis), diabetes, heart disease (such as heart attack),||
8162|101|P|stroke, high cholesterol, mental/mood problems (such as||
8162|102|P|depression), seizures.||
8162|103|P|   Triptorelin may cause a condition that affects the heart||
8162|104|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8162|105|P|serious (rarely fatal) fast/irregular heartbeat and other||
8162|106|P|symptoms (such as severe dizziness, fainting) that need medical||
8162|107|P|attention right away.||
8162|108|P|   The risk of QT prolongation may be increased if you have||
8162|109|P|certain medical conditions or are taking other drugs that may||
8162|110|P|cause QT prolongation. Before using triptorelin, tell your doctor||
8162|111|P|or pharmacist of all the drugs you take and if you have any of||
8162|112|P|the following conditions: certain heart problems (heart failure,||
8162|113|P|slow heartbeat, QT prolongation in the EKG), family history of||
8162|114|P|certain heart problems (QT prolongation in the EKG, sudden||
8162|115|P|cardiac death).||
8162|116|P|   Low levels of potassium or magnesium in the blood may also||
8162|117|P|increase your risk of QT prolongation. This risk may increase if||
8162|118|P|you use certain drugs (such as diuretics/"water pills") or if you||
8162|119|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8162|120|P|Talk to your doctor about using triptorelin safely.||
8162|121|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8162|122|P|can make you more dizzy. Do not drive, use machinery, or do||
8162|123|P|anything that needs alertness until you can do it safely. Limit||
8162|124|P|alcoholic beverages. Talk to your doctor if you are using||
8162|125|P|marijuana (cannabis).||
8162|126|P|   Older adults may be more sensitive to the side effects of this||
8162|127|P|drug, especially QT prolongation (see above).||
8162|128|P|   Females: Triptorelin is not usually used by women. It must not||
8162|129|P|be used by pregnant women because it may harm an unborn baby. If||
8162|130|P|you become pregnant or think you may be pregnant, tell your||
8162|131|P|doctor right away. Breastfeeding is also not recommended during||
8162|132|P|triptorelin treatment. Consult your doctor for more details and||
8162|133|P|before breastfeeding, and to discuss reliable forms of birth||
8162|134|P|control.||
8162|135|B|||
8162|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8162|137|I|medications work or increase your risk for serious side effects.||
8162|138|I|This document does not contain all possible drug interactions.||
8162|139|I|Keep a list of all the products you use (including||
8162|140|I|prescription/nonprescription drugs and herbal products) and share||
8162|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
8162|142|I|the dosage of any medicines without your doctor's approval.||
8162|143|B|||
8162|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8162|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8162|146|O|poison control center right away. US residents can call||
8162|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8162|148|B|||
8162|149|N|NOTES:  Lab and/or medical tests (such as testosterone blood||
8162|150|N|levels, PSA blood tests, blood glucose, cholesterol/triglyceride||
8162|151|N|levels) should be done while you are using this medication. Keep||
8162|152|N|all medical and lab appointments. Consult your doctor for more||
8162|153|N|details.||
8162|154|B|||
8162|155|D|MISSED DOSE:  It is important to get each dose of this medication||
8162|156|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8162|157|D|right away for a new dosing schedule.||
8162|158|B|||
8162|159|R|STORAGE:  Not applicable. This medication is given in a doctor's||
8162|160|R|office and will not be stored at home.||
8162|161|B|||
8162|162|A|Information last revised September 2025.||
8162|163|A|Copyright(c) 2025 First Databank, Inc.||
8162|164|B|||
8164|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8164|002|Z|does NOT have all possible information about this product. This||
8164|003|Z|information does not assure that this product is safe, effective,||
8164|004|Z|or appropriate for you. This information is not individual||
8164|005|Z|medical advice and does not substitute for the advice of your||
8164|006|Z|health care professional. Always ask your health care||
8164|007|Z|professional for complete information about this product and your||
8164|008|Z|specific health needs.||
8164|009|B|||
8164|010|T|ZINC OXIDE - TOPICAL||
8164|011|F|(zink OX-ide)||
8164|012|B|||
8164|013|C|COMMON BRAND NAME(S): Caldesene, Desitin, Elta Seal||
8164|014|B|||
8164|015|U|USES:  This medication is used to treat and prevent diaper rash||
8164|016|U|and other minor skin irritations (such as burns, cuts, scrapes).||
8164|017|U|It works by forming a barrier on the skin to protect it from||
8164|018|U|irritants/moisture.||
8164|019|B|||
8164|020|H|HOW TO USE:  Use this medication on the skin only. Follow all||
8164|021|H|directions on the product package or use as directed by your||
8164|022|H|doctor. If you have any questions, ask your doctor or pharmacist.||
8164|023|H|   Avoid getting this medication in the eyes. If you do get the||
8164|024|H|medication in the eyes, flush with plenty of water.||
8164|025|H|   If you are using the spray, shake the container well before||
8164|026|H|each use.||
8164|027|H|   This medication should start working within 12 hours. Tell||
8164|028|H|your doctor if your condition gets worse, does not get better,||
8164|029|H|lasts for more than 7 days, or occurs again after a few days.||
8164|030|B|||
8164|031|S|SIDE EFFECTS:  If your doctor has directed you to use this||
8164|032|S|medication, remember that your doctor has judged that the benefit||
8164|033|S|to you is greater than the risk of side effects. Many people||
8164|034|S|using this medication do not have serious side effects.||
8164|035|S|   Tell your doctor right away if you have any serious side||
8164|036|S|effects, including: skin irritation.||
8164|037|S|   A very serious allergic reaction to this drug is rare.||
8164|038|S|However, get medical help right away if you notice any symptoms||
8164|039|S|of a serious allergic reaction, including: rash, itching/swelling||
8164|040|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8164|041|S|breathing.||
8164|042|S|   This is not a complete list of possible side effects. If you||
8164|043|S|notice other effects not listed above, contact your doctor or||
8164|044|S|pharmacist.||
8164|045|S|   In the US -||
8164|046|S|   Call your doctor for medical advice about side effects. You||
8164|047|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8164|048|S|www.fda.gov/medwatch.||
8164|049|S|   In Canada - Call your doctor for medical advice about side||
8164|050|S|effects. You may report side effects to Health Canada at||
8164|051|S|1-866-234-2345.||
8164|052|B|||
8164|053|P|PRECAUTIONS:  Before using zinc oxide, tell your doctor or||
8164|054|P|pharmacist if you are allergic to it; or if you have any other||
8164|055|P|allergies. This product may contain inactive ingredients, which||
8164|056|P|can cause allergic reactions or other problems. Talk to your||
8164|057|P|pharmacist for more details.||
8164|058|P|   If you have the following health problem, consult your doctor||
8164|059|P|or pharmacist before using this product: skin infection in the||
8164|060|P|affected area.||
8164|061|P|   Tell your doctor if you are pregnant before using this||
8164|062|P|medication.||
8164|063|P|   It is unknown if this drug passes into breast milk. Consult||
8164|064|P|your doctor before breastfeeding.||
8164|065|B|||
8164|066|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8164|067|I|medications work or increase your risk for serious side effects.||
8164|068|I|This document does not contain all possible drug interactions.||
8164|069|I|Keep a list of all the products you use (including||
8164|070|I|prescription/nonprescription drugs and herbal products) and share||
8164|071|I|it with your doctor and pharmacist. Do not start, stop, or change||
8164|072|I|the dosage of any medicines without your doctor's approval.||
8164|073|B|||
8164|074|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8164|075|O|has overdosed and has serious symptoms such as passing out or||
8164|076|O|trouble breathing, call 911. Otherwise, call a poison control||
8164|077|O|center right away. US residents can call 1-800-222-1222. Canada||
8164|078|O|residents can call 1-844-764-7669.||
8164|079|B|||
8164|080|N|NOTES:  Keep all medical and lab appointments.||
8164|081|N|   To help prevent diaper rash, check your baby's diaper often,||
8164|082|N|and change the diaper whenever it appears wet/dirty.||
8164|083|B|||
8164|084|D|MISSED DOSE:  Not applicable.||
8164|085|B|||
8164|086|R|STORAGE:  Refer to storage information printed on the package. If||
8164|087|R|you have any questions about storage, ask your pharmacist. Keep||
8164|088|R|all medications away from children and pets.||
8164|089|R|   Do not flush medications down the toilet or pour them into a||
8164|090|R|drain unless instructed to do so. Properly discard this product||
8164|091|R|when it is expired or no longer needed. Consult your pharmacist||
8164|092|R|or local waste disposal company.||
8164|093|B|||
8164|094|A|Information last revised November 2024.||
8164|095|A|Copyright(c) 2025 First Databank, Inc.||
8164|096|B|||
8167|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8167|002|Z|does NOT have all possible information about this product. This||
8167|003|Z|information does not assure that this product is safe, effective,||
8167|004|Z|or appropriate for you. This information is not individual||
8167|005|Z|medical advice and does not substitute for the advice of your||
8167|006|Z|health care professional. Always ask your health care||
8167|007|Z|professional for complete information about this product and your||
8167|008|Z|specific health needs.||
8167|009|B|||
8167|010|T|DUTASTERIDE - ORAL||
8167|011|F|(due-TAST-er-ide)||
8167|012|B|||
8167|013|C|COMMON BRAND NAME(S): Avodart||
8167|014|B|||
8167|015|U|USES:  This medication is used in men to treat the symptoms of an||
8167|016|U|enlarged prostate (benign prostatic hyperplasia-BPH). It works by||
8167|017|U|reducing the size of the enlarged prostate. This helps to relieve||
8167|018|U|symptoms of BPH such as difficulty in beginning the flow of||
8167|019|U|urine, weak stream, and the need to urinate often or urgently||
8167|020|U|(including during the middle of the night). It may also reduce||
8167|021|U|the need for surgery to treat BPH.||
8167|022|U|   Dutasteride is not approved for prevention of prostate cancer.||
8167|023|U|It may slightly increase the risk of developing a very serious||
8167|024|U|form of prostate cancer. Talk to your doctor about the benefits||
8167|025|U|and risks.||
8167|026|U|   This medication should not be used by women or children.||
8167|027|B|||
8167|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8167|029|H|from your pharmacist before you start taking this medication and||
8167|030|H|each time you get a refill. If you have any questions, ask your||
8167|031|H|doctor or pharmacist.||
8167|032|H|   Take this medication by mouth with or without food as directed||
8167|033|H|by your doctor, usually once daily. Swallow the medication whole.||
8167|034|H|Do not crush or chew the capsules.||
8167|035|H|   Use this medication regularly to get the most benefit from it.||
8167|036|H|To help you remember, take it at the same time each day.||
8167|037|H|   Since this drug can be absorbed through the skin and may harm||
8167|038|H|an unborn baby, women who are pregnant or who may become pregnant||
8167|039|H|should not handle this medication.||
8167|040|H|   It may take 3 to 6 months to notice an improvement in||
8167|041|H|symptoms. Tell your doctor if your symptoms do not get better or||
8167|042|H|if they get worse.||
8167|043|B|||
8167|044|S|SIDE EFFECTS:  Sexual problems (such as decreased sexual||
8167|045|S|interest/ability, decrease in the amount of semen/sperm),||
8167|046|S|testicle pain/swelling, increased breast size, or breast||
8167|047|S|tenderness may occur. Sexual problems have continued in some men||
8167|048|S|even after stopping treatment. If any of these effects last or||
8167|049|S|get worse, tell your doctor or pharmacist promptly.||
8167|050|S|   Remember that this medication has been prescribed because your||
8167|051|S|doctor has judged that the benefit to you is greater than the||
8167|052|S|risk of side effects. Many people using this medication do not||
8167|053|S|have serious side effects.||
8167|054|S|   A very serious allergic reaction to this drug is rare.||
8167|055|S|However, get medical help right away if you notice any symptoms||
8167|056|S|of a serious allergic reaction, including: rash, itching/swelling||
8167|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8167|058|S|breathing.||
8167|059|S|   This is not a complete list of possible side effects. If you||
8167|060|S|notice other effects not listed above, contact your doctor or||
8167|061|S|pharmacist.||
8167|062|S|   In the US -||
8167|063|S|   Call your doctor for medical advice about side effects. You||
8167|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8167|065|S|www.fda.gov/medwatch.||
8167|066|S|   In Canada - Call your doctor for medical advice about side||
8167|067|S|effects. You may report side effects to Health Canada at||
8167|068|S|1-866-234-2345.||
8167|069|B|||
8167|070|P|PRECAUTIONS:  Before taking dutasteride, tell your doctor or||
8167|071|P|pharmacist if you are allergic to it; or to finasteride; or if||
8167|072|P|you have any other allergies. This product may contain inactive||
8167|073|P|ingredients, which can cause allergic reactions or other||
8167|074|P|problems. Talk to your pharmacist for more details.||
8167|075|P|   Before using this medication, tell your doctor or pharmacist||
8167|076|P|your medical history.||
8167|077|P|   Before having surgery, tell your doctor or dentist about all||
8167|078|P|the products you use (including prescription drugs,||
8167|079|P|nonprescription drugs, and herbal products).||
8167|080|P|   Do not donate blood while you are taking this medication and||
8167|081|P|for at least 6 months after you stop taking it. This will prevent||
8167|082|P|the possibility of your blood being given to a pregnant woman.||
8167|083|P|   This medication should not be used in women, especially during||
8167|084|P|pregnancy or breastfeeding. It may harm an unborn or||
8167|085|P|breastfeeding baby. Consult your doctor for more details.||
8167|086|B|||
8167|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8167|088|I|medications work or increase your risk for serious side effects.||
8167|089|I|This document does not contain all possible drug interactions.||
8167|090|I|Keep a list of all the products you use (including||
8167|091|I|prescription/nonprescription drugs and herbal products) and share||
8167|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
8167|093|I|the dosage of any medicines without your doctor's approval.||
8167|094|B|||
8167|095|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8167|096|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8167|097|O|poison control center right away. US residents can call||
8167|098|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8167|099|B|||
8167|100|N|NOTES:  Do not share this medication with others.||
8167|101|N|   Lab and/or medical tests (such as prostate exams,||
8167|102|N|prostate-specific antigen-PSA) should be done while you are||
8167|103|N|taking this medication. Keep all medical and lab appointments.||
8167|104|N|Consult your doctor for more details.||
8167|105|B|||
8167|106|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8167|107|D|remember. If it is near the time of the next dose, skip the||
8167|108|D|missed dose. Take your next dose at the regular time. Do not||
8167|109|D|double the dose to catch up.||
8167|110|B|||
8167|111|R|STORAGE:  Store at room temperature away from light and moisture.||
8167|112|R|Do not store in the bathroom. Keep all medications away from||
8167|113|R|children and pets.||
8167|114|R|   Dutasteride capsules may soften and leak if stored at high||
8167|115|R|temperatures. If your capsules crack and leak, do not use them.||
8167|116|R|If your skin comes in contact with the leaking capsules, wash the||
8167|117|R|area right away with soap and water. Contact your pharmacist for||
8167|118|R|more information.||
8167|119|R|   Do not flush medications down the toilet or pour them into a||
8167|120|R|drain unless instructed to do so. Properly discard this product||
8167|121|R|when it is expired or no longer needed. Consult your pharmacist||
8167|122|R|or local waste disposal company.||
8167|123|B|||
8167|124|A|Information last revised November 2024.||
8167|125|A|Copyright(c) 2025 First Databank, Inc.||
8167|126|B|||
8168|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8168|002|Z|does NOT have all possible information about this product. This||
8168|003|Z|information does not assure that this product is safe, effective,||
8168|004|Z|or appropriate for you. This information is not individual||
8168|005|Z|medical advice and does not substitute for the advice of your||
8168|006|Z|health care professional. Always ask your health care||
8168|007|Z|professional for complete information about this product and your||
8168|008|Z|specific health needs.||
8168|009|B|||
8168|010|T|PROPRANOLOL S.R. - ORAL||
8168|011|F|(pro-PRAN-oh-lol)||
8168|012|B|||
8168|013|C|COMMON BRAND NAME(S): Inderal LA||
8168|014|B|||
8168|015|W|WARNING:  Do not stop using this drug without first consulting||
8168|016|W|your doctor. Your condition may become worse when the drug is||
8168|017|W|suddenly stopped, especially if you have chest pain (angina) or||
8168|018|W|heart disease (such as coronary artery disease, ischemic heart||
8168|019|W|disease, high blood pressure). If your doctor decides you should||
8168|020|W|no longer use this drug, you must gradually decrease your dose||
8168|021|W|according to your doctor's instructions.||
8168|022|W|   When gradually stopping this medication, it is recommended||
8168|023|W|that you temporarily limit physical activity to decrease strain||
8168|024|W|on the heart. Get medical help right away if you develop:||
8168|025|W|worsening chest pain, tightness/pressure in the chest, chest pain||
8168|026|W|spreading to the jaw/neck/arm, unusual sweating, trouble||
8168|027|W|breathing, or fast/irregular heartbeat.||
8168|028|B|||
8168|029|U|USES:  This medication is a beta blocker used to treat high blood||
8168|030|U|pressure, irregular heartbeats, shaking (tremors), and other||
8168|031|U|conditions as determined by your doctor. It is used after a heart||
8168|032|U|attack to improve survival. It is also used to prevent migraine||
8168|033|U|headaches and chest pain (angina). Lowering high blood pressure||
8168|034|U|helps prevent strokes, heart attacks, and kidney problems.||
8168|035|U|Preventing chest pain can help improve your ability to exercise.||
8168|036|U|   This drug works by blocking the action of certain natural||
8168|037|U|chemicals in your body (such as epinephrine) that affect the||
8168|038|U|heart and blood vessels. This effect reduces heart rate, blood||
8168|039|U|pressure, and strain on the heart.||
8168|040|B|||
8168|041|H|HOW TO USE:  See also Warning section.||
8168|042|H|   Take this medication by mouth as directed by your doctor,||
8168|043|H|usually once daily. Swallow the capsules whole; do not crush or||
8168|044|H|chew the capsules.||
8168|045|H|   The dosage is based on your medical condition and response to||
8168|046|H|treatment.||
8168|047|H|   Use this medication regularly to get the most benefit from it.||
8168|048|H|To help you remember, take it at the same time each day. Keep||
8168|049|H|taking this medication even if you feel well.||
8168|050|H|   This medication is used to help prevent chest pain or||
8168|051|H|migraines. It should not be used to treat chest pain or migraines||
8168|052|H|when they occur. Use other medications (such as nitroglycerin||
8168|053|H|tablets placed under the tongue for chest pain, sumatriptan for||
8168|054|H|migraines) to relieve sudden attacks as directed by your doctor.||
8168|055|H|Consult your doctor or pharmacist for details.||
8168|056|H|   It may take 1 to 2 weeks before you get the full benefit of||
8168|057|H|this drug.||
8168|058|H|   If you also take certain drugs to lower your cholesterol (bile||
8168|059|H|acid-binding resins such as cholestyramine or colestipol), take||
8168|060|H|propranolol at least 1 hour before or at least 4 hours after||
8168|061|H|these medications.||
8168|062|H|   Tell your doctor if your condition does not get better or if||
8168|063|H|it gets worse (for example, your blood pressure readings remain||
8168|064|H|high or increase, your chest pain or migraines occur more often).||
8168|065|B|||
8168|066|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
8168|067|S|   Dizziness, lightheadedness, or tiredness may occur as your||
8168|068|S|body adjusts to the medication. Nausea/vomiting, stomach pain,||
8168|069|S|vision changes, trouble sleeping, and unusual dreams may also||
8168|070|S|occur. If any of these effects last or get worse, tell your||
8168|071|S|doctor or pharmacist promptly.||
8168|072|S|   To reduce the risk of dizziness and lightheadedness, get up||
8168|073|S|slowly when rising from a sitting or lying position.||
8168|074|S|   This drug may reduce blood flow to your hands and feet,||
8168|075|S|causing them to feel cold. Smoking may worsen this effect. Dress||
8168|076|S|warmly and avoid tobacco use.||
8168|077|S|   Remember that this medication has been prescribed because your||
8168|078|S|doctor has judged that the benefit to you is greater than the||
8168|079|S|risk of side effects. Many people using this medication do not||
8168|080|S|have serious side effects.||
8168|081|S|   Tell your doctor right away if you have any serious side||
8168|082|S|effects, including: blue fingers/toes, mental/mood changes (such||
8168|083|S|as depression), numbness/tingling of arms/legs, new or worsening||
8168|084|S|symptoms of heart failure (such as shortness of breath, swelling||
8168|085|S|ankles/feet, unusual tiredness, unusual/sudden weight gain), very||
8168|086|S|slow heartbeat, fainting, decreased sexual ability, increased||
8168|087|S|thirst/urination, easy bruising/bleeding, signs of infection||
8168|088|S|(such as sore throat that doesn't go away, fever, chills),||
8168|089|S|aching/swollen joints.||
8168|090|S|   A very serious allergic reaction to this drug is rare.||
8168|091|S|However, get medical help right away if you notice any symptoms||
8168|092|S|of a serious allergic reaction, including: rash, itching/swelling||
8168|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8168|094|S|breathing.||
8168|095|S|   This is not a complete list of possible side effects. If you||
8168|096|S|notice other effects not listed above, contact your doctor or||
8168|097|S|pharmacist.||
8168|098|S|   In the US -||
8168|099|S|   Call your doctor for medical advice about side effects. You||
8168|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8168|101|S|www.fda.gov/medwatch.||
8168|102|S|   In Canada - Call your doctor for medical advice about side||
8168|103|S|effects. You may report side effects to Health Canada at||
8168|104|S|1-866-234-2345.||
8168|105|B|||
8168|106|P|PRECAUTIONS:  Before taking propranolol, tell your doctor or||
8168|107|P|pharmacist if you are allergic to it; or if you have had a||
8168|108|P|serious reaction to other beta blockers (such as metoprolol); or||
8168|109|P|if you have any other allergies. This product may contain||
8168|110|P|inactive ingredients, which can cause allergic reactions or other||
8168|111|P|problems. Talk to your pharmacist for more details.||
8168|112|P|   Before using this medication, tell your doctor or pharmacist||
8168|113|P|your medical history, especially of: other breathing problems||
8168|114|P|(such as asthma, bronchitis, emphysema), heart failure, certain||
8168|115|P|types of heart rhythm problems (sinus bradycardia,||
8168|116|P|Wolff-Parkinson-White syndrome, second- or third-degree||
8168|117|P|atrioventricular block), overactive thyroid (hyperthyroidism),||
8168|118|P|kidney disease, liver disease, blood circulation problems (such||
8168|119|P|as Raynaud's disease), a certain adrenal gland tumor||
8168|120|P|(pheochromocytoma), mental/mood disorders (such as depression),||
8168|121|P|certain muscle/nerve disease (myasthenia gravis), severe allergic||
8168|122|P|reactions.||
8168|123|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8168|124|P|can make you more dizzy. Do not drive, use machinery, or do||
8168|125|P|anything that needs alertness until you can do it safely. Limit||
8168|126|P|alcoholic beverages. Talk to your doctor if you are using||
8168|127|P|marijuana (cannabis).||
8168|128|P|   Before having surgery, tell your doctor or dentist about all||
8168|129|P|the products you use (including prescription drugs,||
8168|130|P|nonprescription drugs, and herbal products).||
8168|131|P|   This product may prevent the fast/pounding heartbeat you would||
8168|132|P|usually feel when your blood sugar level falls too low||
8168|133|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
8168|134|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
8168|135|P|blood sugar level, such as dizziness and sweating, are not||
8168|136|P|affected by this drug.||
8168|137|P|   If you have diabetes, this product may make it harder to||
8168|138|P|control your blood sugar levels. Check your blood sugar levels||
8168|139|P|regularly as directed by your doctor. Tell your doctor right away||
8168|140|P|if you have symptoms of high blood sugar such as increased||
8168|141|P|thirst/urination. Your doctor may need to adjust your diabetes||
8168|142|P|medication, exercise program, or diet.||
8168|143|P|   Children may be at greater risk for low blood sugar||
8168|144|P|(hypoglycemia) while using this drug, especially if they are||
8168|145|P|vomiting or not eating regularly. To help prevent low blood||
8168|146|P|sugar, make sure children eat regularly. If your child cannot eat||
8168|147|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
8168|148|P|as sweating, shaking), tell the doctor right away.||
8168|149|P|   During pregnancy, this medication should be used only when||
8168|150|P|clearly needed. Infants exposed to this medication during||
8168|151|P|pregnancy may have low birth weight, low blood sugar, or slow||
8168|152|P|breathing/heartbeat. Discuss the risks and benefits with your||
8168|153|P|doctor.||
8168|154|P|   This drug passes into breast milk. Consult your doctor before||
8168|155|P|breastfeeding.||
8168|156|B|||
8168|157|I|DRUG INTERACTIONS:  See also How to Use section.||
8168|158|I|   Drug interactions may change how your medications work or||
8168|159|I|increase your risk for serious side effects. This document does||
8168|160|I|not contain all possible drug interactions. Keep a list of all||
8168|161|I|the products you use (including prescription/nonprescription||
8168|162|I|drugs and herbal products) and share it with your doctor and||
8168|163|I|pharmacist. Do not start, stop, or change the dosage of any||
8168|164|I|medicines without your doctor's approval.||
8168|165|I|   Some products that may interact with this drug are:||
8168|166|I|epinephrine, fingolimod.||
8168|167|I|   Other medications can affect the removal of propranolol from||
8168|168|I|your body, which may affect how propranolol works. Examples||
8168|169|I|include quinidine, rifamycins (such as rifabutin), among others.||
8168|170|I|   This medication can slow down the removal of other medications||
8168|171|I|from your body, which may affect how they work. Examples of||
8168|172|I|affected drugs include fezolinetant, propafenone, thioridazine,||
8168|173|I|among others.||
8168|174|I|   Some products have ingredients that could raise your heart||
8168|175|I|rate or blood pressure. Tell your pharmacist what products you||
8168|176|I|are using, and ask how to use them safely (especially||
8168|177|I|cough-and-cold products, diet aids, or NSAIDs such as||
8168|178|I|ibuprofen/naproxen).||
8168|179|I|   This medication may interfere with certain lab tests (such as||
8168|180|I|glaucoma screening test), possibly causing false test results.||
8168|181|I|Make sure lab personnel and all your doctors know you use this||
8168|182|I|drug.||
8168|183|B|||
8168|184|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8168|185|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8168|186|O|poison control center right away. US residents can call||
8168|187|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8168|188|O|Symptoms of overdose may include unusually slow heartbeat, severe||
8168|189|O|dizziness, slow or shallow breathing, weakness, or fainting.||
8168|190|B|||
8168|191|N|NOTES:  Do not share this medication with others. Lifestyle||
8168|192|N|changes such as stress reduction programs, exercise and dietary||
8168|193|N|changes may increase the effectiveness of this medicine. Talk to||
8168|194|N|your doctor or pharmacist about lifestyle changes that might||
8168|195|N|benefit you.||
8168|196|N|   Have your blood pressure and pulse checked regularly while||
8168|197|N|taking this medication. It may be best to learn how to monitor||
8168|198|N|your own blood pressure and pulse. Discuss this with your doctor.||
8168|199|B|||
8168|200|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8168|201|D|remember. If it is within 8 hours of the next dose, skip the||
8168|202|D|missed dose. Take your next dose at the regular time. Do not||
8168|203|D|double the dose to catch up.||
8168|204|B|||
8168|205|R|STORAGE:  Store at room temperature away from light and moisture.||
8168|206|R|Do not store in the bathroom. Keep all medications away from||
8168|207|R|children and pets.||
8168|208|R|   Do not flush medications down the toilet or pour them into a||
8168|209|R|drain unless instructed to do so. Properly discard this product||
8168|210|R|when it is expired or no longer needed. Consult your pharmacist||
8168|211|R|or local waste disposal company.||
8168|212|B|||
8168|213|M|MEDICAL ALERT:  Your condition can cause complications in a||
8168|214|M|medical emergency. For information about enrolling in MedicAlert,||
8168|215|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8168|216|B|||
8168|217|A|Information last revised May 2025.||
8168|218|A|Copyright(c) 2025 First Databank, Inc.||
8168|219|B|||
8169|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8169|002|Z|does NOT have all possible information about this product. This||
8169|003|Z|information does not assure that this product is safe, effective,||
8169|004|Z|or appropriate for you. This information is not individual||
8169|005|Z|medical advice and does not substitute for the advice of your||
8169|006|Z|health care professional. Always ask your health care||
8169|007|Z|professional for complete information about this product and your||
8169|008|Z|specific health needs.||
8169|009|B|||
8169|010|T|DIPHTHERIA/TETANUS VACCINE (ADULT) - INJECTION||
8169|011|F|(dip-THEER-ee-uh AND TET-un-us)||
8169|012|B|||
8169|013|C|COMMON BRAND NAME(S): TDVAX||
8169|014|B|||
8169|015|U|USES:  This vaccine is used to help prevent diphtheria and||
8169|016|U|tetanus (lockjaw) in people 7 years and older. Vaccination is the||
8169|017|U|best way to protect against these life-threatening diseases. This||
8169|018|U|vaccine works by increasing the body's natural defense (immunity)||
8169|019|U|against the bacteria.||
8169|020|U|   Vaccines may not fully protect everyone who receives them.||
8169|021|B|||
8169|022|H|HOW TO USE:  Read all vaccine information available from your||
8169|023|H|health care professional before receiving the vaccine. If you||
8169|024|H|have any questions, ask your health care professional.||
8169|025|H|   This vaccine is given by injection into the muscle of the||
8169|026|H|upper arm by a health care professional.||
8169|027|H|   Vaccines are usually given in a series of doses to provide the||
8169|028|H|best protection. Closely follow the vaccination schedule provided||
8169|029|H|by your health care professional. To help you remember, mark your||
8169|030|H|calendar with a reminder.||
8169|031|H|   This vaccine may be given at the same time as other vaccines.||
8169|032|B|||
8169|033|S|SIDE EFFECTS:  Pain/redness/warmth/bruising/swelling at the||
8169|034|S|injection site, tiredness, fever, or headache may occur. If any||
8169|035|S|of these effects last or get worse, tell the health care||
8169|036|S|professional promptly.||
8169|037|S|   Rarely, some people have symptoms such as fainting, dizziness,||
8169|038|S|vision changes, or ringing in the ears just after getting a||
8169|039|S|vaccine injection. Tell your health care professional right away||
8169|040|S|if you have any of these symptoms. Sitting or lying down may||
8169|041|S|help, since these symptoms usually don't last long.||
8169|042|S|   Remember that this vaccine has been prescribed because the||
8169|043|S|health care professional has judged that the benefit to you or||
8169|044|S|your child is greater than the risk of side effects. Many people||
8169|045|S|using this vaccine do not have serious side effects.||
8169|046|S|   Tell your health care professional right away if you or your||
8169|047|S|child have any serious side effects, including: muscle weakness,||
8169|048|S|numbness/tingling, severe pain/swelling at the injection site.||
8169|049|S|   A very serious allergic reaction to this vaccine is rare.||
8169|050|S|However, get medical help right away if you notice any symptoms||
8169|051|S|of a serious allergic reaction, including: rash, itching/swelling||
8169|052|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8169|053|S|breathing.||
8169|054|S|   This is not a complete list of possible side effects. If you||
8169|055|S|notice other effects not listed above, contact the health care||
8169|056|S|professional.||
8169|057|S|   Contact your health care professional for medical advice about||
8169|058|S|side effects. The following numbers do not provide medical||
8169|059|S|advice, but in the US you may report side effects to the Vaccine||
8169|060|S|Adverse Event Reporting System (VAERS) at 1-800-822-7967. In||
8169|061|S|Canada, you may call the Vaccine Safety Section at Public Health||
8169|062|S|Agency of Canada at 1-866-844-0018.||
8169|063|B|||
8169|064|P|PRECAUTIONS:  Before you receive this vaccine, tell the health||
8169|065|P|care professional if you are allergic to it; or if you have any||
8169|066|P|other allergies. This product may contain inactive ingredients||
8169|067|P|(such as thimerosal), which can cause allergic reactions or other||
8169|068|P|problems. Talk to your health care professional for more details.||
8169|069|P|   Before receiving this vaccine, tell your health care||
8169|070|P|professional your medical history, especially of: current||
8169|071|P|fever/illness, vaccination history (including previous reactions||
8169|072|P|to any vaccines), a certain nerve disorder (Guillain-Barre||
8169|073|P|syndrome), immune system disorders (such as due to HIV infection,||
8169|074|P|certain cancers such as leukemia/lymphoma, cancer or radiation||
8169|075|P|treatment).||
8169|076|P|   During pregnancy, this vaccine should be used only when||
8169|077|P|clearly needed. Discuss the risks and benefits with your health||
8169|078|P|care professional.||
8169|079|P|   It is unknown if this vaccine passes into breast milk. Consult||
8169|080|P|your health care professional before breastfeeding.||
8169|081|B|||
8169|082|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8169|083|I|medications work or increase your risk for serious side effects.||
8169|084|I|This document does not contain all possible drug interactions.||
8169|085|I|Keep a list of all the products you use (such as||
8169|086|I|prescription/nonprescription drugs and herbal products) and share||
8169|087|I|it with your health care professional. Do not start, stop, or||
8169|088|I|change the dosage of any medicines without your doctor's||
8169|089|I|approval.||
8169|090|I|   Some products that may interact with this vaccine are: drugs||
8169|091|I|that weaken the immune system (such as cyclosporine, tacrolimus,||
8169|092|I|cancer chemotherapy, corticosteroids such as prednisone).||
8169|093|B|||
8169|094|O|OVERDOSE:  Not applicable.||
8169|095|B|||
8169|096|N|NOTES:  Keep all medical and lab appointments.||
8169|097|N|   Keep vaccine records for yourself and your children and||
8169|098|N|provide them to the health care professionals to prevent||
8169|099|N|unnecessary re-vaccinations.||
8169|100|B|||
8169|101|D|MISSED DOSE:  It is important that you or your child get each||
8169|102|D|vaccination as scheduled. Ask when you or your child should get||
8169|103|D|each dose and mark your calendar with a reminder. If you or your||
8169|104|D|child miss a dose, call the health care professional to||
8169|105|D|reschedule.||
8169|106|B|||
8169|107|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
8169|108|R|medications away from children and pets.||
8169|109|R|   Do not flush medications down the toilet or pour them into a||
8169|110|R|drain unless instructed to do so. Properly discard this product||
8169|111|R|when it is expired or no longer needed. Consult your pharmacist||
8169|112|R|or local waste disposal company.||
8169|113|B|||
8169|114|A|Information last revised February 2025.||
8169|115|A|Copyright(c) 2025 First Databank, Inc.||
8169|116|B|||
8170|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8170|002|Z|does NOT have all possible information about this product. This||
8170|003|Z|information does not assure that this product is safe, effective,||
8170|004|Z|or appropriate for you. This information is not individual||
8170|005|Z|medical advice and does not substitute for the advice of your||
8170|006|Z|health care professional. Always ask your health care||
8170|007|Z|professional for complete information about this product and your||
8170|008|Z|specific health needs.||
8170|009|B|||
8170|010|T|LIDOCAINE/PRILOCAINE CREAM - TOPICAL||
8170|011|F|(LYE-doe-kane/PRILL-oh-cane)||
8170|012|B|||
8170|013|C|COMMON BRAND NAME(S): EMLA||
8170|014|B|||
8170|015|U|USES:  This medication contains 2 amide-type local anesthetics,||
8170|016|U|lidocaine and prilocaine. It is used on normal, unbroken skin or||
8170|017|U|on the outer genital area to prevent pain before certain||
8170|018|U|procedures such as inserting a needle, skin grafts, or skin laser||
8170|019|U|surgery. It works by temporarily numbing the skin and surrounding||
8170|020|U|area. Do not use this product in the ears.||
8170|021|U|   If this product alone cannot completely numb the area being||
8170|022|U|treated, it may be used to numb the area before a lidocaine||
8170|023|U|injection is given to provide enough pain relief for certain||
8170|024|U|procedures (such as removal of genital warts).||
8170|025|B|||
8170|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8170|027|H|from your pharmacist before you start using lidocaine/prilocaine||
8170|028|H|cream and each time you get a refill. If you have any questions,||
8170|029|H|ask your doctor or pharmacist.||
8170|030|H|   Use this medication only on normal skin and the genital area.||
8170|031|H|Do not apply to broken/irritated skin or open wounds unless||
8170|032|H|directed by your doctor. Wash your hands before using this||
8170|033|H|product.||
8170|034|H|   Apply this product to the area at the proper time as directed.||
8170|035|H|The length of time for the medication to stay on the skin depends||
8170|036|H|on the type of procedure you are having. It is usually applied at||
8170|037|H|least 1 hour before needle sticks and 2 hours before minor skin||
8170|038|H|procedures. It may be applied by a health care professional||
8170|039|H|before certain genital procedures. In this case, it is||
8170|040|H|recommended that you remain lying down so the medication will||
8170|041|H|stay in place.||
8170|042|H|   To apply, squeeze out the prescribed amount of cream directly||
8170|043|H|onto the skin. You can also squeeze it onto a measuring guide to||
8170|044|H|make sure you get the right dose and then apply it to the area.||
8170|045|H|Do not rub in. Cover with an airtight dressing/bandage as||
8170|046|H|directed by your doctor. Allow the cream to remain in place,||
8170|047|H|usually in a thick layer, as directed by your doctor. Remove the||
8170|048|H|dressing and cream and clean the area thoroughly, usually shortly||
8170|049|H|before the procedure or as directed by your doctor.||
8170|050|H|   The dosage and length of application time are based on your||
8170|051|H|age and medical condition and the procedure you are having.||
8170|052|H|Children's dosage may also be based on weight. Do not use larger||
8170|053|H|amounts than prescribed. Do not use on large areas of skin, apply||
8170|054|H|heat, or leave it in place longer than directed or serious side||
8170|055|H|effects may occur.||
8170|056|H|   If you are applying this product on a child, make sure the||
8170|057|H|medication stays in place and that your child does not put the||
8170|058|H|medication or dressing/bandage in his/her mouth. You may want to||
8170|059|H|use a second covering to prevent the child from touching the||
8170|060|H|cream.||
8170|061|H|   Wash hands immediately after use unless you are treating an||
8170|062|H|area on the hands. Avoid getting the product in your eyes, nose,||
8170|063|H|ears, or mouth. If this medication gets in the eyes, rinse the||
8170|064|H|affected eye immediately and completely with water or saline.||
8170|065|H|Numbness in the eye can lead to injury because you cannot feel||
8170|066|H|particles in the eye or other dangers. Protect the eye until||
8170|067|H|feeling returns.||
8170|068|H|   The area may be numb for several hours after the procedure.||
8170|069|H|Protect the area from injury. Be careful not to bump, rub, or||
8170|070|H|scratch the area or expose it to heat/cold until feeling returns.||
8170|071|B|||
8170|072|S|SIDE EFFECTS:  Redness, swelling, tingling/burning, or lightening||
8170|073|S|of the skin may occur. If any of these effects last or get worse,||
8170|074|S|tell your doctor or pharmacist promptly.||
8170|075|S|   Remember that this medication has been prescribed because your||
8170|076|S|doctor has judged that the benefit to you is greater than the||
8170|077|S|risk of side effects. Many people using this medication do not||
8170|078|S|have serious side effects.||
8170|079|S|   Tell your doctor right away if you have any serious side||
8170|080|S|effects, including: blistering of the skin where the drug is||
8170|081|S|applied.||
8170|082|S|   Remove the cream and get medical help right away if you have||
8170|083|S|any very serious side effects, including: slow/shallow breathing,||
8170|084|S|dizziness, fainting, fast/slow/irregular heartbeat, mental/mood||
8170|085|S|changes (such as confusion, nervousness), seizures, severe||
8170|086|S|drowsiness, pale/bluish/gray skin, unusual tiredness, shortness||
8170|087|S|of breath.||
8170|088|S|   A very serious allergic reaction to this drug is rare.||
8170|089|S|However, get medical help right away if you notice any symptoms||
8170|090|S|of a serious allergic reaction, including: rash, itching/swelling||
8170|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8170|092|S|breathing.||
8170|093|S|   This is not a complete list of possible side effects. If you||
8170|094|S|notice other effects not listed above, contact your doctor or||
8170|095|S|pharmacist.||
8170|096|S|   In the US -||
8170|097|S|   Call your doctor for medical advice about side effects. You||
8170|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8170|099|S|www.fda.gov/medwatch.||
8170|100|S|   In Canada - Call your doctor for medical advice about side||
8170|101|S|effects. You may report side effects to Health Canada at||
8170|102|S|1-866-234-2345.||
8170|103|B|||
8170|104|P|PRECAUTIONS:  Before using this product, tell your doctor or||
8170|105|P|pharmacist if you are allergic to lidocaine or prilocaine; or to||
8170|106|P|any other amide anesthetics (such as bupivacaine); or if you have||
8170|107|P|any other allergies. This product may contain inactive||
8170|108|P|ingredients, which can cause allergic reactions or other||
8170|109|P|problems. Talk to your pharmacist for more details.||
8170|110|P|   Before using this medication, tell your doctor or pharmacist||
8170|111|P|your medical history, especially of: heart disease (such as||
8170|112|P|irregular heartbeat), kidney disease, liver disease, a certain||
8170|113|P|blood disorder (methemoglobinemia).||
8170|114|P|   Older adults may be more sensitive to the side effects of this||
8170|115|P|drug, especially dizziness.||
8170|116|P|   During pregnancy, this medication should be used only when||
8170|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
8170|118|P|   Lidocaine passes into breast milk. It is unknown if prilocaine||
8170|119|P|passes into breast milk. Consult your doctor before||
8170|120|P|breastfeeding.||
8170|121|B|||
8170|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8170|123|I|medications work or increase your risk for serious side effects.||
8170|124|I|This document does not contain all possible drug interactions.||
8170|125|I|Keep a list of all the products you use (including||
8170|126|I|prescription/nonprescription drugs and herbal products) and share||
8170|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
8170|128|I|the dosage of any medicines without your doctor's approval.||
8170|129|B|||
8170|130|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8170|131|O|has overdosed and has serious symptoms such as passing out or||
8170|132|O|trouble breathing, call 911. Otherwise, call a poison control||
8170|133|O|center right away. US residents can call 1-800-222-1222. Canada||
8170|134|O|residents can call 1-844-764-7669. Symptoms of overdose may||
8170|135|O|include: seizures, loss of consciousness.||
8170|136|B|||
8170|137|N|NOTES:  Do not share this medication with others.||
8170|138|B|||
8170|139|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
8170|140|D|right away for a new dosing schedule.||
8170|141|B|||
8170|142|R|STORAGE:  Store at room temperature. Keep all medications away||
8170|143|R|from children and pets.||
8170|144|R|   Do not flush medications down the toilet or pour them into a||
8170|145|R|drain unless instructed to do so. Properly discard this product||
8170|146|R|when it is expired or no longer needed. Consult your pharmacist||
8170|147|R|or local waste disposal company.||
8170|148|B|||
8170|149|A|Information last revised September 2024.||
8170|150|A|Copyright(c) 2025 First Databank, Inc.||
8170|151|B|||
8172|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8172|002|Z|does NOT have all possible information about this product. This||
8172|003|Z|information does not assure that this product is safe, effective,||
8172|004|Z|or appropriate for you. This information is not individual||
8172|005|Z|medical advice and does not substitute for the advice of your||
8172|006|Z|health care professional. Always ask your health care||
8172|007|Z|professional for complete information about this product and your||
8172|008|Z|specific health needs.||
8172|009|B|||
8172|010|T|OPIOID ANTITUSSIVE/ANTIHISTAMINE - ORAL||
8172|011|B|||
8172|012|W|WARNING:  This medication has a risk for abuse and addiction,||
8172|013|W|which can lead to overdose and death. This medication may also||
8172|014|W|cause severe, possibly fatal, breathing problems. To lower your||
8172|015|W|risk, your doctor should have you take the smallest dose that||
8172|016|W|works, and take it for the shortest possible time. See also How||
8172|017|W|to Use section for more information about addiction.||
8172|018|W|   The risk for severe breathing problems is higher when you||
8172|019|W|start this medication, or if you take the wrong dose or take more||
8172|020|W|of this medication than prescribed. Taking this medication with||
8172|021|W|alcohol or other drugs that can cause drowsiness or breathing||
8172|022|W|problems may cause very serious side effects, including death.||
8172|023|W|Also, other medications can affect the removal of this product||
8172|024|W|from your body, which may affect how it works. Be sure you know||
8172|025|W|how to take this product and what other drugs you should avoid||
8172|026|W|taking with it. See also Drug Interactions section. Get medical||
8172|027|W|help right away if any of these very serious side effects occur:||
8172|028|W|slow/shallow breathing, unusual lightheadedness, severe||
8172|029|W|drowsiness/dizziness, difficulty waking up.||
8172|030|W|   Keep this medicine in a safe place to prevent theft, misuse,||
8172|031|W|or abuse. If someone accidentally swallows this drug, get medical||
8172|032|W|help right away.||
8172|033|W|   Before using this medication, women of childbearing age should||
8172|034|W|talk with their doctor(s) about the risks and benefits. Tell your||
8172|035|W|doctor if you are pregnant or think you may be pregnant. During||
8172|036|W|pregnancy, this medication is not recommended. It may slightly||
8172|037|W|increase the risk of birth defects if used during the first two||
8172|038|W|months of pregnancy. Also, using it for a long time or in high||
8172|039|W|doses near the expected delivery date may harm the unborn baby.||
8172|040|W|To lessen the risk, take the smallest effective dose for the||
8172|041|W|shortest possible time. Babies born to mothers who use this drug||
8172|042|W|for a long time may develop severe (possibly fatal) withdrawal||
8172|043|W|symptoms. Tell the doctor right away if you notice any symptoms||
8172|044|W|in your newborn baby such as crying that doesn't stop,||
8172|045|W|slow/shallow breathing, irritability, shaking, vomiting,||
8172|046|W|diarrhea, poor feeding, or difficulty gaining weight.||
8172|047|B|||
8172|048|U|USES:  This combination product is used to treat symptoms caused||
8172|049|U|by the common cold, flu, allergies, hay fever, or other breathing||
8172|050|U|illnesses (such as sinusitis, bronchitis). This product contains||
8172|051|U|an opioid cough suppressant (antitussive) that affects a certain||
8172|052|U|part of the brain, reducing the urge to cough. Antihistamines||
8172|053|U|relieve watery eyes, itchy eyes/nose/throat, runny nose, and||
8172|054|U|sneezing.||
8172|055|U|   Opioid cough suppressants should not be used by children||
8172|056|U|younger than 18 years. Children are at higher risk for serious||
8172|057|U|(even fatal) side effects, especially breathing problems. Talk||
8172|058|U|with the doctor about the risks and benefits of this medication.||
8172|059|U|   Cough-and-cold products do not cure colds. Cough due to a||
8172|060|U|common cold often does not need to be treated with medicine. Ask||
8172|061|U|your doctor or pharmacist about other ways to relieve cough and||
8172|062|U|cold symptoms, such as drinking enough fluids, using a||
8172|063|U|humidifier, or saline nose drops/spray.||
8172|064|B|||
8172|065|H|HOW TO USE:  Read the Medication Guide and, if available, the||
8172|066|H|Patient Information Leaflet provided by your pharmacist before||
8172|067|H|you start taking this product and each time you get a refill. If||
8172|068|H|you have any questions, ask your doctor or pharmacist.||
8172|069|H|   Take this medication by mouth with or without food with a full||
8172|070|H|glass of water (8 ounces or 240 milliliters) as directed by your||
8172|071|H|doctor. This medication may be taken with food or milk if stomach||
8172|072|H|upset occurs. Do not take the sustained-release products more||
8172|073|H|often than every 12 hours.||
8172|074|H|   If you are using the liquid form, use a medication measuring||
8172|075|H|device or spoon to carefully measure the prescribed dose. Do not||
8172|076|H|use a household spoon because you may not get the correct dose.||
8172|077|H|If your liquid form is a suspension, shake the bottle well before||
8172|078|H|each dose.||
8172|079|H|   If you are using the extended-release capsules, swallow them||
8172|080|H|whole. Do not crush or chew extended-release capsules or tablets.||
8172|081|H|Doing so can release all of the drug at once, increasing the risk||
8172|082|H|of side effects. Swallow the whole tablet without crushing or||
8172|083|H|chewing.||
8172|084|H|   If you are using a sustained-release liquid that contains||
8172|085|H|hydrocodone polistirex or codeine polistirex, do not mix the||
8172|086|H|liquid with other liquids or medications. Doing so can destroy||
8172|087|H|the long action of the drug and may increase side effects.||
8172|088|H|   Do not increase your dose or use this product more often or||
8172|089|H|for longer than prescribed. Your condition will not improve any||
8172|090|H|faster, and your risk of side effects will increase.||
8172|091|H|   If you suddenly stop using this medication, you may have||
8172|092|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
8172|093|H|nose, nausea, sweating, muscle aches). To help prevent||
8172|094|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
8172|095|H|more likely if you have used this medication for a long time||
8172|096|H|(more than a few weeks) or in high doses. Tell your doctor or||
8172|097|H|pharmacist right away if you have withdrawal.||
8172|098|H|   Though it helps many people, this product may sometimes cause||
8172|099|H|addiction. This risk may be higher if you have a mental/mood||
8172|100|H|disorder or a substance use disorder (such as overuse of or||
8172|101|H|addiction to drugs/alcohol). Take this product exactly as||
8172|102|H|prescribed to lower the risk of addiction. Ask your doctor or||
8172|103|H|pharmacist for more details.||
8172|104|H|   When used for an extended time, this medication may not work||
8172|105|H|as well and may require different dosing. Talk with your doctor||
8172|106|H|if this medication stops working well.||
8172|107|H|   Tell your doctor if your cough does not get better in 5 days.||
8172|108|H|Also, tell your doctor if your condition gets worse, or if you||
8172|109|H|have a headache that doesn't go away, fever, or rash. These may||
8172|110|H|be symptoms of a serious medical problem and should be checked by||
8172|111|H|a doctor.||
8172|112|B|||
8172|113|S|SIDE EFFECTS:  See also Warning section.||
8172|114|S|   Drowsiness, dizziness, headache, blurred vision, upset||
8172|115|S|stomach, nausea, constipation, or dry mouth/nose/throat may||
8172|116|S|occur. If any of these effects last or get worse, tell your||
8172|117|S|doctor or pharmacist promptly.||
8172|118|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
8172|119|S|chips, chew (sugarless) gum, drink water, or use a saliva||
8172|120|S|substitute. This medication can dry up and thicken mucus in your||
8172|121|S|lungs, making it more difficult to breathe and clear your lungs.||
8172|122|S|To help prevent this effect, drink plenty of fluids unless||
8172|123|S|otherwise directed by your doctor.||
8172|124|S|   To reduce the risk of dizziness and lightheadedness, get up||
8172|125|S|slowly when rising from a sitting or lying position.||
8172|126|S|   Remember that this medication has been prescribed because your||
8172|127|S|doctor has judged that the benefit to you is greater than the||
8172|128|S|risk of side effects. Many people using this medication do not||
8172|129|S|have serious side effects.||
8172|130|S|   Tell your doctor right away if you have any serious side||
8172|131|S|effects, including: interrupted breathing during sleep (sleep||
8172|132|S|apnea), mental/mood changes (such as hallucinations), ringing in||
8172|133|S|the ears, trouble urinating, easy bruising/bleeding,||
8172|134|S|fast/slow/irregular heartbeat, trouble swallowing.||
8172|135|S|   Get medical help right away if you have any very serious side||
8172|136|S|effects, including: seizure.||
8172|137|S|   This product may cause serious mental/mood changes and very||
8172|138|S|serious (rarely fatal) breathing problems. This product may||
8172|139|S|contain codeine or dihydrocodeine. Codeine and dihydrocodeine are||
8172|140|S|changed into strong opioid drugs (morphine or dihydromorphine) in||
8172|141|S|your body. In some people this happens faster and more completely||
8172|142|S|than usual, which increases the risk of very serious side||
8172|143|S|effects. Get medical help right away if you notice any of the||
8172|144|S|following: slow/shallow breathing, severe drowsiness/difficulty||
8172|145|S|waking up, confusion.||
8172|146|S|   A very serious allergic reaction to this drug is rare.||
8172|147|S|However, get medical help right away if you notice any symptoms||
8172|148|S|of a serious allergic reaction, including: rash, itching/swelling||
8172|149|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8172|150|S|breathing.||
8172|151|S|   This is not a complete list of possible side effects. If you||
8172|152|S|notice other effects not listed above, contact your doctor or||
8172|153|S|pharmacist.||
8172|154|S|   In the US -||
8172|155|S|   Call your doctor for medical advice about side effects. You||
8172|156|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8172|157|S|www.fda.gov/medwatch.||
8172|158|S|   In Canada - Call your doctor for medical advice about side||
8172|159|S|effects. You may report side effects to Health Canada at||
8172|160|S|1-866-234-2345.||
8172|161|B|||
8172|162|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
8172|163|P|pharmacist if you are allergic to it; or if you have any other||
8172|164|P|allergies. This product may contain inactive ingredients, which||
8172|165|P|can cause allergic reactions or other problems. Talk to your||
8172|166|P|pharmacist for more details.||
8172|167|P|   Before using this medication, tell your doctor or pharmacist||
8172|168|P|your medical history, especially of: abdominal problems (such as||
8172|169|P|chronic constipation, ileus, pancreatitis), gallbladder disease,||
8172|170|P|adrenal gland problem (such as Addison's disease), certain brain||
8172|171|P|disorders (such as head injury, tumor, increased intracranial||
8172|172|P|pressure), breathing problems (such as asthma, emphysema, sleep||
8172|173|P|apnea), diabetes, a certain eye problem (glaucoma), heart||
8172|174|P|problems, high blood pressure, kidney problems, liver disease,||
8172|175|P|mental/mood problems (such as depression, psychosis), seizures,||
8172|176|P|stomach/intestinal problems (such as ulcers, blockage),||
8172|177|P|underactive thyroid (hypothyroidism), urination problems (such as||
8172|178|P|trouble urinating due to enlarged prostate, urinary retention),||
8172|179|P|personal or family history of a substance use disorder (such as||
8172|180|P|overuse of or addiction to drugs/alcohol), obesity.||
8172|181|P|   This drug may make you dizzy or drowsy or blur your vision.||
8172|182|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8172|183|P|drowsy. Do not drive, use machinery, or do anything that needs||
8172|184|P|alertness or clear vision until you can do it safely. Avoid||
8172|185|P|alcoholic beverages. Talk to your doctor if you are using||
8172|186|P|marijuana (cannabis).||
8172|187|P|   Before having surgery, tell your doctor or dentist about all||
8172|188|P|the products you use (including prescription drugs,||
8172|189|P|nonprescription drugs, and herbal products).||
8172|190|P|   Liquid products may contain alcohol, sugar, and/or aspartame.||
8172|191|P|Caution is advised if you have diabetes, liver disease,||
8172|192|P|phenylketonuria (PKU), or any other condition that requires you||
8172|193|P|to limit/avoid these substances in your diet. Ask your doctor or||
8172|194|P|pharmacist about using this product safely.||
8172|195|P|   Older adults may be more sensitive to the side effects of this||
8172|196|P|drug, especially confusion, dizziness, drowsiness, and||
8172|197|P|slow/shallow breathing.||
8172|198|P|   Tell your doctor if you are pregnant or think you may be||
8172|199|P|pregnant. During pregnancy, this product is not recommended. It||
8172|200|P|may harm an unborn baby. Talk to your doctor about the risks and||
8172|201|P|benefits of this medication. See also Warning section.||
8172|202|P|   This product may pass into breast milk and may have||
8172|203|P|undesirable effects on a nursing infant (such as unusual||
8172|204|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
8172|205|P|limpness). Consult your doctor before breastfeeding.||
8172|206|B|||
8172|207|I|DRUG INTERACTIONS:  See also Warning section.||
8172|208|I|   Drug interactions may change how your medications work or||
8172|209|I|increase your risk for serious side effects. This document does||
8172|210|I|not contain all possible drug interactions. Keep a list of all||
8172|211|I|the products you use (including prescription/nonprescription||
8172|212|I|drugs and herbal products) and share it with your doctor and||
8172|213|I|pharmacist. Do not start, stop, or change the dosage of any||
8172|214|I|medicines without your doctor's approval.||
8172|215|I|   Some products that may interact with this drug include:||
8172|216|I|antihistamines applied to the skin (such as diphenhydramine||
8172|217|I|cream, ointment, spray), naltrexone, samidorphan.||
8172|218|I|   The risk of serious side effects (such as slow/shallow||
8172|219|I|breathing, severe drowsiness/dizziness) may be increased if this||
8172|220|I|medication is taken with other products that may also cause||
8172|221|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
8172|222|I|if you are taking other products such as other opioid pain or||
8172|223|I|cough relievers (such as codeine, hydrocodone), alcohol,||
8172|224|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
8172|225|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
8172|226|I|carisoprodol, cyclobenzaprine), or other antihistamines (such as||
8172|227|I|cetirizine, diphenhydramine).||
8172|228|I|   Check the labels on all your medicines (such as allergy or||
8172|229|I|cough-and-cold products) because they may contain ingredients||
8172|230|I|that cause drowsiness. Ask your pharmacist about using those||
8172|231|I|products safely.||
8172|232|I|   Other medications can affect the removal of this product from||
8172|233|I|your body, which may affect how this product works. Examples||
8172|234|I|include azole antifungals (such as ketoconazole), bupropion,||
8172|235|I|fluoxetine, macrolide antibiotics (such as erythromycin),||
8172|236|I|paroxetine, quinidine, rifamycins (such as rifabutin, rifampin),||
8172|237|I|ritonavir, certain drugs used to treat seizures (such as||
8172|238|I|carbamazepine, phenytoin), among others.||
8172|239|I|   This medication may interfere with certain lab tests (such as||
8172|240|I|amylase/lipase levels, allergy skin test), possibly causing false||
8172|241|I|test results. Make sure lab personnel and all your doctors know||
8172|242|I|you use this drug.||
8172|243|B|||
8172|244|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8172|245|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8172|246|O|poison control center right away. US residents can call||
8172|247|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8172|248|O|Symptoms of overdose may include: confusion, cold/clammy skin,||
8172|249|O|fast/slow/irregular heartbeat, slow/shallow breathing, seizures,||
8172|250|O|coma.||
8172|251|B|||
8172|252|N|NOTES:  Do not share this medication with others. Sharing it is||
8172|253|N|against the law.||
8172|254|B|||
8172|255|D|MISSED DOSE:  If you are prescribed this medication on a regular||
8172|256|D|schedule and miss a dose, take it as soon as you remember. If it||
8172|257|D|is near the time of the next dose, skip the missed dose. Take||
8172|258|D|your next dose at the regular time. Do not double the dose to||
8172|259|D|catch up.||
8172|260|B|||
8172|261|R|STORAGE:  Store at room temperature away from light and moisture.||
8172|262|R|Do not store in the bathroom. Do not freeze. Keep all medications||
8172|263|R|away from children and pets.||
8172|264|R|   Do not flush medications down the toilet or pour them into a||
8172|265|R|drain unless instructed to do so. Properly discard this product||
8172|266|R|when it is expired or no longer needed. Consult your pharmacist||
8172|267|R|or local waste disposal company.||
8172|268|B|||
8172|269|A|Information last revised August 2025.||
8172|270|A|Copyright(c) 2025 First Databank, Inc.||
8172|271|B|||
8176|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8176|002|Z|does NOT have all possible information about this product. This||
8176|003|Z|information does not assure that this product is safe, effective,||
8176|004|Z|or appropriate for you. This information is not individual||
8176|005|Z|medical advice and does not substitute for the advice of your||
8176|006|Z|health care professional. Always ask your health care||
8176|007|Z|professional for complete information about this product and your||
8176|008|Z|specific health needs.||
8176|009|B|||
8176|010|T|IMIGLUCERASE - INJECTION||
8176|011|F|(im-eh-GLUE-ser-aze)||
8176|012|B|||
8176|013|C|COMMON BRAND NAME(S): Cerezyme||
8176|014|B|||
8176|015|W|WARNING:  Imiglucerase may cause serious (sometimes fatal)||
8176|016|W|allergic reactions. Get medical help right away if you have any||
8176|017|W|symptoms of a serious allergic reaction such as rash,||
8176|018|W|itching/swelling (especially of the face/tongue/throat), severe||
8176|019|W|dizziness, or trouble breathing.||
8176|020|B|||
8176|021|U|USES:  Imiglucerase is used to treat a certain rare genetic||
8176|022|U|problem (Gaucher disease). Imiglucerase replaces a certain||
8176|023|U|natural substance (an enzyme called glucocerebrosidase) that is||
8176|024|U|missing in people with Gaucher disease.||
8176|025|U|   This medication improves blood, bone, liver, and spleen||
8176|026|U|problems caused by Gaucher disease. Imiglucerase does not correct||
8176|027|U|the genetic problem, and treatment must be continued for life.||
8176|028|B|||
8176|029|H|HOW TO USE:  This medication is given by injection into a vein by||
8176|030|H|a health care professional. It is injected slowly into a vein||
8176|031|H|over 1 to 2 hours as directed by your doctor. The dosage and how||
8176|032|H|often it is given depends on your weight, medical condition, and||
8176|033|H|response to treatment. Follow your doctor's directions carefully.||
8176|034|H|   Infusion reactions may happen during the infusion of this drug||
8176|035|H|and for a short time afterward. Tell your doctor right away if||
8176|036|H|you have symptoms of infusion reactions such as shortness of||
8176|037|H|breath, cough, flushing, dizziness, high blood pressure, or fast||
8176|038|H|heartbeat. Your doctor may give you other medications to help||
8176|039|H|with these side effects or may slow down or stop your treatment||
8176|040|H|for some time.||
8176|041|H|   Tell your doctor if your condition lasts or gets worse. Blood,||
8176|042|H|liver, and spleen problems usually improve in the first year of||
8176|043|H|treatment. It may take 2 to 3 years of treatment to see the full||
8176|044|H|benefit to your bones.||
8176|045|B|||
8176|046|S|SIDE EFFECTS:  See also Warning and How to Use sections.||
8176|047|S|   Fever, headache, nausea, vomiting, swelling of the hands/feet||
8176|048|S|(edema), or redness/pain/itching/swelling at the injection site||
8176|049|S|may occur. If any of these effects last or get worse, tell your||
8176|050|S|doctor or pharmacist promptly.||
8176|051|S|   Remember that this medication has been prescribed because your||
8176|052|S|doctor has judged that the benefit to you is greater than the||
8176|053|S|risk of side effects. Many people using this medication do not||
8176|054|S|have serious side effects.||
8176|055|S|   This is not a complete list of possible side effects. If you||
8176|056|S|notice other effects not listed above, contact your doctor or||
8176|057|S|pharmacist.||
8176|058|S|   In the US -||
8176|059|S|   Call your doctor for medical advice about side effects. You||
8176|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8176|061|S|www.fda.gov/medwatch.||
8176|062|S|   In Canada - Call your doctor for medical advice about side||
8176|063|S|effects. You may report side effects to Health Canada at||
8176|064|S|1-866-234-2345.||
8176|065|B|||
8176|066|P|PRECAUTIONS:  Before using imiglucerase, tell your doctor or||
8176|067|P|pharmacist if you are allergic to it; or to alglucerase; or if||
8176|068|P|you have any other allergies. This product may contain inactive||
8176|069|P|ingredients, which can cause allergic reactions or other||
8176|070|P|problems. Talk to your pharmacist for more details.||
8176|071|P|   Before using this medication, tell your doctor or pharmacist||
8176|072|P|your medical history.||
8176|073|P|   Before having surgery, tell your doctor or dentist about all||
8176|074|P|the products you use (including prescription drugs,||
8176|075|P|nonprescription drugs, and herbal products).||
8176|076|P|   During pregnancy, this medication should be used only when||
8176|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
8176|078|P|   This medication may pass into breast milk. Consult your doctor||
8176|079|P|before breastfeeding.||
8176|080|B|||
8176|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8176|082|I|medications work or increase your risk for serious side effects.||
8176|083|I|This document does not contain all possible drug interactions.||
8176|084|I|Keep a list of all the products you use (including||
8176|085|I|prescription/nonprescription drugs and herbal products) and share||
8176|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
8176|087|I|the dosage of any medicines without your doctor's approval.||
8176|088|B|||
8176|089|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8176|090|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8176|091|O|poison control center right away. US residents can call||
8176|092|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8176|093|B|||
8176|094|N|NOTES:  Lab and/or medical tests (such as IgG antibodies) should||
8176|095|N|be done while you are using this medication. Keep all medical and||
8176|096|N|lab appointments. Consult your doctor for more details.||
8176|097|B|||
8176|098|D|MISSED DOSE:  It is important to get each dose of this medication||
8176|099|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8176|100|D|right away for a new dosing schedule.||
8176|101|B|||
8176|102|R|STORAGE:  Not applicable. This medication is given in a hospital||
8176|103|R|or clinic or doctor's office and will not be stored at home.||
8176|104|B|||
8176|105|A|Information last revised December 2024.||
8176|106|A|Copyright(c) 2025 First Databank, Inc.||
8176|107|B|||
8177|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8177|002|Z|does NOT have all possible information about this product. This||
8177|003|Z|information does not assure that this product is safe, effective,||
8177|004|Z|or appropriate for you. This information is not individual||
8177|005|Z|medical advice and does not substitute for the advice of your||
8177|006|Z|health care professional. Always ask your health care||
8177|007|Z|professional for complete information about this product and your||
8177|008|Z|specific health needs.||
8177|009|B|||
8177|010|T|TRYPTOPHAN - ORAL||
8177|011|F|(TRIP-toe-fan)||
8177|012|B|||
8177|013|U|USES:  In Canada, tryptophan is sold as a prescription drug to||
8177|014|U|treat mood disorders (such as bipolar disorder, depression). It||
8177|015|U|is usually used with other medicines. It works to make the mood||
8177|016|U|more stable and reduce extremes in behavior by restoring the||
8177|017|U|balance of certain natural substances (serotonin, melatonin) in||
8177|018|U|the brain. Tryptophan is a natural substance (amino acid) found||
8177|019|U|in high-protein foods and milk.||
8177|020|U|   In the US, tryptophan is sold as a dietary supplement. It has||
8177|021|U|been used to support mood, relaxation, and restful sleep. If you||
8177|022|U|are taking other medications that may affect serotonin (such as||
8177|023|U|many antidepressants), do not take tryptophan without talking||
8177|024|U|with your doctor first. A very serious (possibly fatal) drug||
8177|025|U|interaction may occur. Your doctor should closely monitor you.||
8177|026|U|See also Side Effects section.||
8177|027|U|   Some supplement products have been found to contain possibly||
8177|028|U|harmful impurities/additives. Check with your pharmacist for more||
8177|029|U|details about the brand you use.||
8177|030|U|   The US FDA has not reviewed this product for safety or||
8177|031|U|effectiveness. Consult your doctor or pharmacist for more||
8177|032|U|details.||
8177|033|B|||
8177|034|H|HOW TO USE:  If your doctor has prescribed this medication, take||
8177|035|H|it by mouth with a meal or snack as directed by your doctor,||
8177|036|H|usually 3 to 4 times a day. Taking this medication with food||
8177|037|H|helps reduce side effects such as nausea.||
8177|038|H|   Dosage is based on your medical condition and response to||
8177|039|H|treatment. Your doctor may adjust your dose to find the best dose||
8177|040|H|for you. Do not take this medication more often, increase your||
8177|041|H|dose, or stop taking it without first consulting your doctor.||
8177|042|H|Your condition will not improve faster and your risk of side||
8177|043|H|effects will increase.||
8177|044|H|   If your doctor has prescribed this medication, use it||
8177|045|H|regularly to get the most benefit from it. To help you remember,||
8177|046|H|take it at the same times each day.||
8177|047|H|   If you are using tryptophan as a dietary supplement, take this||
8177|048|H|product by mouth as directed. Follow all directions on the||
8177|049|H|product package. If you have any questions, ask your doctor or||
8177|050|H|pharmacist.||
8177|051|H|   Consult your doctor or pharmacist before using this product||
8177|052|H|for any mental/mood disorders such as depression or bipolar||
8177|053|H|disorder. Your condition may require medical attention or||
8177|054|H|prescribed medication.||
8177|055|H|   Tell your doctor if your condition lasts or gets worse. If you||
8177|056|H|think you may have a serious medical problem, get medical help||
8177|057|H|right away.||
8177|058|B|||
8177|059|S|SIDE EFFECTS:  Nausea, loss of appetite, dizziness, drowsiness,||
8177|060|S|headache, or dry mouth may occur. If any of these effects last or||
8177|061|S|get worse, tell your doctor or pharmacist promptly.||
8177|062|S|   If your doctor has prescribed this medication, remember that||
8177|063|S|your doctor has judged that the benefit to you is greater than||
8177|064|S|the risk of side effects. Many people using this medication do||
8177|065|S|not have serious side effects.||
8177|066|S|   Tell your doctor right away if you have any serious side||
8177|067|S|effects, including: muscle stiffness/spasms, severe muscle||
8177|068|S|aches/pain, unusual/inappropriate sexual urges, shakiness||
8177|069|S|(tremor), unusual weakness.||
8177|070|S|   This medication may increase serotonin and rarely cause a very||
8177|071|S|serious condition called serotonin syndrome/toxicity. The risk||
8177|072|S|increases if you are also taking other drugs that increase||
8177|073|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
8177|074|S|take (see Drug Interactions section). Get medical help right away||
8177|075|S|if you develop some of the following symptoms: fast heartbeat,||
8177|076|S|hallucinations, loss of coordination, severe dizziness, severe||
8177|077|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
8177|078|S|unusual agitation/restlessness.||
8177|079|S|   A very serious allergic reaction to this product is rare.||
8177|080|S|However, get medical help right away if you notice any symptoms||
8177|081|S|of a serious allergic reaction, including: rash, itching/swelling||
8177|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8177|083|S|breathing.||
8177|084|S|   This is not a complete list of possible side effects. If you||
8177|085|S|notice other effects not listed above, contact your doctor or||
8177|086|S|pharmacist.||
8177|087|S|   In the US -||
8177|088|S|   Call your doctor for medical advice about side effects. You||
8177|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8177|090|S|www.fda.gov/medwatch.||
8177|091|S|   In Canada - Call your doctor for medical advice about side||
8177|092|S|effects. You may report side effects to Health Canada at||
8177|093|S|1-866-234-2345.||
8177|094|B|||
8177|095|P|PRECAUTIONS:  Before taking tryptophan, tell your doctor or||
8177|096|P|pharmacist if you are allergic to it; or if you have any other||
8177|097|P|allergies. This product may contain inactive ingredients, which||
8177|098|P|can cause allergic reactions or other problems. Talk to your||
8177|099|P|pharmacist for more details.||
8177|100|P|   Before using this medication, tell your doctor or pharmacist||
8177|101|P|your medical history, especially of: a certain muscle reaction to||
8177|102|P|tryptophan (eosinophilia-myalgia syndrome), personal/family||
8177|103|P|history of diabetes, digestive problems (such as achlorhydria,||
8177|104|P|malabsorption), low-protein diet, scleroderma.||
8177|105|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8177|106|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8177|107|P|machinery, or do anything that needs alertness until you can do||
8177|108|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8177|109|P|are using marijuana (cannabis).||
8177|110|P|   During pregnancy, this medication should be used only when||
8177|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
8177|112|P|   It is unknown if this drug passes into breast milk. Consult||
8177|113|P|your doctor before breastfeeding.||
8177|114|B|||
8177|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8177|116|I|medications work or increase your risk for serious side effects.||
8177|117|I|This document does not contain all possible drug interactions.||
8177|118|I|Keep a list of all the products you use (including||
8177|119|I|prescription/nonprescription drugs and herbal products) and share||
8177|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
8177|121|I|the dosage of any medicines without your doctor's approval.||
8177|122|I|   A product that may interact with this drug is: sodium oxybate.||
8177|123|I|   Taking MAO inhibitors with this medication may cause a serious||
8177|124|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
8177|125|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8177|126|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8177|127|I|selegiline, tranylcypromine) during treatment with this||
8177|128|I|medication. Most MAO inhibitors should also not be taken for two||
8177|129|I|weeks before and after treatment with this medication. Ask your||
8177|130|I|doctor when to start or stop taking this medication.||
8177|131|I|   The risk of serotonin syndrome/toxicity increases if you are||
8177|132|I|also taking other drugs that increase serotonin. Examples include||
8177|133|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
8177|134|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
8177|135|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
8177|136|I|serotonin syndrome/toxicity may be more likely when you start or||
8177|137|I|increase the dose of these drugs.||
8177|138|I|   Tell your doctor or pharmacist if you are taking other||
8177|139|I|products that cause drowsiness such as opioid pain or cough||
8177|140|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8177|141|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
8177|142|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
8177|143|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8177|144|I|diphenhydramine).||
8177|145|I|   Check the labels on all your medicines (such as allergy or||
8177|146|I|cough-and-cold products) because they may contain ingredients||
8177|147|I|that cause drowsiness. Ask your pharmacist about using those||
8177|148|I|products safely.||
8177|149|B|||
8177|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8177|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8177|152|O|poison control center right away. US residents can call||
8177|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8177|154|O|Symptoms of overdose may include: seizures, loss of||
8177|155|O|consciousness.||
8177|156|B|||
8177|157|N|NOTES:  Do not share this medication with others. Keep all||
8177|158|N|medical and lab appointments.||
8177|159|B|||
8177|160|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8177|161|D|remember. If it is near the time of the next dose, skip the||
8177|162|D|missed dose. Take your next dose at the regular time. Do not||
8177|163|D|double the dose to catch up.||
8177|164|B|||
8177|165|R|STORAGE:  Different brands of this medication have different||
8177|166|R|storage needs. Check the product package for instructions on how||
8177|167|R|to store your brand, or ask your pharmacist. Keep all medications||
8177|168|R|away from children and pets.||
8177|169|R|   Do not flush medications down the toilet or pour them into a||
8177|170|R|drain unless instructed to do so. Properly discard this product||
8177|171|R|when it is expired or no longer needed. Consult your pharmacist||
8177|172|R|or local waste disposal company.||
8177|173|B|||
8177|174|A|Information last revised February 2025.||
8177|175|A|Copyright(c) 2025 First Databank, Inc.||
8177|176|B|||
8179|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8179|002|Z|does NOT have all possible information about this product. This||
8179|003|Z|information does not assure that this product is safe, effective,||
8179|004|Z|or appropriate for you. This information is not individual||
8179|005|Z|medical advice and does not substitute for the advice of your||
8179|006|Z|health care professional. Always ask your health care||
8179|007|Z|professional for complete information about this product and your||
8179|008|Z|specific health needs.||
8179|009|B|||
8179|010|T|TIOCONAZOLE - VAGINAL||
8179|011|F|(tie-oh-CON-uh-zole)||
8179|012|B|||
8179|013|C|COMMON BRAND NAME(S): Vagistat-1||
8179|014|B|||
8179|015|U|USES:  This medication is used to treat vaginal yeast infections.||
8179|016|U|Tioconazole ointment reduces vaginal burning, itching, and||
8179|017|U|discharge that may occur with this condition. This medication is||
8179|018|U|an azole antifungal. It works by stopping the growth of yeast||
8179|019|U|(fungus) that causes the infection.||
8179|020|U|   Ask your doctor before using this medication for||
8179|021|U|self-treatment if this is your first vaginal infection. This||
8179|022|U|medication only works for vaginal fungal infections. You may have||
8179|023|U|a different type of infection (such as bacterial vaginosis) and||
8179|024|U|may need a different medication.||
8179|025|U|   If you have fever, chills, flu-like symptoms,||
8179|026|U|stomach/abdominal pain, or a bad-smelling vaginal discharge, do||
8179|027|U|not use this medication. Contact your doctor right away because||
8179|028|U|these may be signs of a more serious infection.||
8179|029|B|||
8179|030|H|HOW TO USE:  If you are using the over-the-counter product to||
8179|031|H|self-treat, read all directions on the product package before||
8179|032|H|using this medication. If you have any questions, consult your||
8179|033|H|pharmacist. If your doctor has prescribed this medication, use it||
8179|034|H|as directed.||
8179|035|H|   This product is for vaginal use only. Wash your hands before||
8179|036|H|and after use. Avoid contact of this ointment with your eyes. If||
8179|037|H|it gets into your eyes, wash them right away with plenty of||
8179|038|H|water. Call your doctor if eye irritation lasts.||
8179|039|H|   Dosage is based on your medical condition and response to||
8179|040|H|treatment.||
8179|041|H|   This product is usually given as a single dose at bedtime or||
8179|042|H|as directed by your doctor. Learn all preparation and usage||
8179|043|H|instructions in the product package. Lie on your back with your||
8179|044|H|knees toward your chest. Insert the applicator filled with||
8179|045|H|medication into the vagina as far as it will comfortably go.||
8179|046|H|Slowly press the plunger of the applicator in to apply the full||
8179|047|H|dose of the ointment. If you have itching/burning around the||
8179|048|H|outside of the vagina (vulva), you may also apply some ointment||
8179|049|H|to that area.||
8179|050|H|   Do not use tampons, douches, spermicides, or other vaginal||
8179|051|H|products while using this medication. Unscented sanitary napkins||
8179|052|H|may be used for your menstrual period or to protect your clothing||
8179|053|H|from leakage of the medication.||
8179|054|H|   Tell your doctor if your condition does not get better after 3||
8179|055|H|days or lasts more than 7 days, or if your infection returns||
8179|056|H|within 2 months. You may need a different or additional||
8179|057|H|medication to treat your condition.||
8179|058|B|||
8179|059|S|SIDE EFFECTS:  Headache or vaginal/urethral burning/itching/pain||
8179|060|S|may occur. If any of these effects last or get worse, tell your||
8179|061|S|doctor or pharmacist promptly.||
8179|062|S|   If your doctor has prescribed this medication, remember that||
8179|063|S|your doctor has judged that the benefit to you is greater than||
8179|064|S|the risk of side effects. Many people using this medication do||
8179|065|S|not have serious side effects.||
8179|066|S|   A very serious allergic reaction to this drug is rare.||
8179|067|S|However, get medical help right away if you notice any symptoms||
8179|068|S|of a serious allergic reaction, including: rash, itching/swelling||
8179|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8179|070|S|breathing.||
8179|071|S|   This is not a complete list of possible side effects. If you||
8179|072|S|notice other effects not listed above, contact your doctor or||
8179|073|S|pharmacist.||
8179|074|S|   In the US -||
8179|075|S|   Call your doctor for medical advice about side effects. You||
8179|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8179|077|S|www.fda.gov/medwatch.||
8179|078|S|   In Canada - Call your doctor for medical advice about side||
8179|079|S|effects. You may report side effects to Health Canada at||
8179|080|S|1-866-234-2345.||
8179|081|B|||
8179|082|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
8179|083|P|pharmacist if you are allergic to it; or to other azole||
8179|084|P|antifungal agents (such as clotrimazole, fluconazole); or if you||
8179|085|P|have any other allergies. This product may contain inactive||
8179|086|P|ingredients, which can cause allergic reactions or other||
8179|087|P|problems. Talk to your pharmacist for more details.||
8179|088|P|   If you have any of the following health problems, consult your||
8179|089|P|doctor or pharmacist before using this medication: diabetes,||
8179|090|P|immune system problems (such as HIV-AIDS), frequent vaginal yeast||
8179|091|P|infections (more than 3 in 6 months or 4 in 1 year).||
8179|092|P|   Before having surgery, tell your doctor or dentist about all||
8179|093|P|the products you use (including prescription drugs,||
8179|094|P|nonprescription drugs, and herbal products).||
8179|095|P|   Ask your doctor whether you can have sexual intercourse while||
8179|096|P|using this product. This product may weaken rubber products (such||
8179|097|P|as latex condoms, diaphragms, cervical caps) and lead to failure.||
8179|098|P|This can result in pregnancy. Do not use these products during||
8179|099|P|treatment with this medication and for 3 days after treatment is||
8179|100|P|over. Consult your doctor about other forms of barrier||
8179|101|P|protection/birth control (such as polyurethane condoms) during||
8179|102|P|this time.||
8179|103|P|   Do not use this medication for self-treatment if you are||
8179|104|P|pregnant. During pregnancy, this medication should be used only||
8179|105|P|when clearly needed. If you are pregnant, follow your doctor's||
8179|106|P|instructions on how to use the applicator to insert this||
8179|107|P|medication. Discuss the risks and benefits with your doctor.||
8179|108|P|   It is unknown if this drug passes into breast milk. Consult||
8179|109|P|your doctor before breastfeeding.||
8179|110|B|||
8179|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8179|112|I|medications work or increase your risk for serious side effects.||
8179|113|I|This document does not contain all possible drug interactions.||
8179|114|I|Keep a list of all the products you use (including||
8179|115|I|prescription/nonprescription drugs and herbal products) and share||
8179|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
8179|117|I|the dosage of any medicines without your doctor's approval.||
8179|118|B|||
8179|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8179|120|O|has overdosed and has serious symptoms such as passing out or||
8179|121|O|trouble breathing, call 911. Otherwise, call a poison control||
8179|122|O|center right away. US residents can call 1-800-222-1222. Canada||
8179|123|O|residents can call 1-844-764-7669.||
8179|124|B|||
8179|125|N|NOTES:  To help prevent vaginal yeast infections, dry the genital||
8179|126|N|area thoroughly after showering, bathing, or swimming. Avoid||
8179|127|N|wearing tight jeans, nylon underwear, pantyhose, a wet bathing||
8179|128|N|suit, or damp/sweaty exercise clothes for long periods. Wear||
8179|129|N|cotton underwear, and change your underwear daily.||
8179|130|N|   If your sexual partner experiences symptoms, they should||
8179|131|N|contact their doctor right away.||
8179|132|B|||
8179|133|D|MISSED DOSE:  Not applicable.||
8179|134|B|||
8179|135|R|STORAGE:  Store at room temperature. Keep all medications away||
8179|136|R|from children and pets.||
8179|137|R|   Do not flush medications down the toilet or pour them into a||
8179|138|R|drain unless instructed to do so. Properly discard this product||
8179|139|R|when it is expired or no longer needed. Consult your pharmacist||
8179|140|R|or local waste disposal company.||
8179|141|B|||
8179|142|A|Information last revised November 2024.||
8179|143|A|Copyright(c) 2025 First Databank, Inc.||
8179|144|B|||
8183|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8183|002|Z|does NOT have all possible information about this product. This||
8183|003|Z|information does not assure that this product is safe, effective,||
8183|004|Z|or appropriate for you. This information is not individual||
8183|005|Z|medical advice and does not substitute for the advice of your||
8183|006|Z|health care professional. Always ask your health care||
8183|007|Z|professional for complete information about this product and your||
8183|008|Z|specific health needs.||
8183|009|B|||
8183|010|T|THALIDOMIDE - ORAL||
8183|011|F|(tha-LID-oh-mide)||
8183|012|B|||
8183|013|C|COMMON BRAND NAME(S): Thalomid||
8183|014|B|||
8183|015|W|WARNING:  Women who are pregnant must not use thalidomide. Women||
8183|016|W|must avoid becoming pregnant while taking this medication. Even a||
8183|017|W|single dose of thalidomide has caused severe (often fatal) birth||
8183|018|W|defects when used during pregnancy. You must have 2 negative||
8183|019|W|pregnancy tests before you start treatment with thalidomide||
8183|020|W|(within 10 to 14 days before and 24 hours before starting),||
8183|021|W|repeating the test at least monthly. Do not start or continue||
8183|022|W|thalidomide treatment unless you have a negative pregnancy test||
8183|023|W|result.||
8183|024|W|   Female patients must use 2 effective forms of birth control||
8183|025|W|(or completely avoid sexual intercourse) for 1 month before||
8183|026|W|starting thalidomide, during use, and for 1 month after stopping||
8183|027|W|this drug. Talk to your doctor about reliable birth control||
8183|028|W|choices. If your period is late, or if you have sexual||
8183|029|W|intercourse at any time without using 2 effective forms of birth||
8183|030|W|control, stop taking this medication and contact your doctor||
8183|031|W|right away. (See also Precautions section.)||
8183|032|W|   Because thalidomide also passes into semen, men who use this||
8183|033|W|drug and have sex with women must use a latex condom during all||
8183|034|W|sexual contact, even if they have had a vasectomy. Keep using||
8183|035|W|condoms and other birth control as directed until 1 month after||
8183|036|W|thalidomide treatment has been stopped.||
8183|037|W|   To receive thalidomide in the United States, you must||
8183|038|W|understand, agree to, and carefully follow the requirements of||
8183|039|W|the REMS Program for this medication. If you live in Canada or||
8183|040|W|any other country, consult your doctor and pharmacist for your||
8183|041|W|country's regulations.||
8183|042|W|   When used to treat a certain type of cancer (multiple||
8183|043|W|myeloma), thalidomide can increase the risk of serious problems||
8183|044|W|from blood clots (such as heart attack, stroke, blood clots in||
8183|045|W|the lungs or legs). Get medical help right away if you develop||
8183|046|W|shortness of breath/rapid breathing, chest/jaw/left arm pain,||
8183|047|W|weakness on one side of the body, trouble speaking, sudden vision||
8183|048|W|changes, unusual sweating, confusion, sudden dizziness/fainting,||
8183|049|W|pain/swelling/warmth in the groin/calf, or sudden/severe||
8183|050|W|headaches. While you are taking thalidomide, your doctor may also||
8183|051|W|direct you to take aspirin or other "blood thinners" (such as||
8183|052|W|warfarin) to lessen the risk of these types of blood clots. Talk||
8183|053|W|to your doctor for more information, and tell him/her if you have||
8183|054|W|diabetes, high blood pressure or high cholesterol, kidney||
8183|055|W|problems, or if you smoke. (See also Side Effects section.)||
8183|056|B|||
8183|057|U|USES:  This medication is used to treat or prevent certain skin||
8183|058|U|conditions related to Hansen's disease, once known as leprosy||
8183|059|U|(erythema nodosum leprosum). Thalidomide is also used to treat a||
8183|060|U|certain type of cancer (multiple myeloma). It works in Hansen's||
8183|061|U|disease by reducing swelling and redness (inflammation). It also||
8183|062|U|reduces the formation of blood vessels that feed tumors.||
8183|063|B|||
8183|064|V|OTHER USES:  This section contains uses of this drug that are not||
8183|065|V|listed in the approved professional labeling for the drug but||
8183|066|V|that may be prescribed by your health care professional. Use this||
8183|067|V|drug for a condition that is listed in this section only if it||
8183|068|V|has been so prescribed by your health care professional.||
8183|069|V|   This drug may also be used for lupus, certain conditions||
8183|070|V|caused by cancer, and HIV infection.||
8183|071|B|||
8183|072|H|HOW TO USE:  Read the Medication Guide provided by your||
8183|073|H|pharmacist before you start using thalidomide and each time you||
8183|074|H|get a refill. If you have any questions, ask your doctor or||
8183|075|H|pharmacist.||
8183|076|H|   Take this medication by mouth as directed by your doctor,||
8183|077|H|usually once daily at bedtime at least 1 hour after the evening||
8183|078|H|meal. Swallow this medication whole with water.||
8183|079|H|   Dosage is based on your medical condition and response to||
8183|080|H|treatment. Do not increase your dose or take this medication more||
8183|081|H|often than prescribed. Your condition will not improve any||
8183|082|H|faster, and the risk of serious side effects may be increased.||
8183|083|H|   Keep the capsules in their blister pack until ready to use. Do||
8183|084|H|not open or break the capsules, or handle them any more than||
8183|085|H|needed. If any of the powder from the capsule gets on your skin,||
8183|086|H|wash the area with soap and water.||
8183|087|H|   Since this drug can be absorbed through the skin and lungs and||
8183|088|H|may harm an unborn baby, women who are pregnant or who may become||
8183|089|H|pregnant should not handle this medication or breathe the dust||
8183|090|H|from broken capsules. All people should wash their hands||
8183|091|H|thoroughly after handling this drug.||
8183|092|H|   This medication passes into body fluids (such as urine). Avoid||
8183|093|H|contact with body fluids from people taking this drug. Wear||
8183|094|H|protective clothing (such as gloves) when handling these body||
8183|095|H|fluids (such as during cleanup). If contact occurs, wash skin||
8183|096|H|with soap and water.||
8183|097|H|   Use this medication regularly to get the most benefit from it.||
8183|098|H|To help you remember, take it at the same time each day. If you||
8183|099|H|are taking this medication for Hansen's disease, your skin||
8183|100|H|condition may become worse when the drug is suddenly stopped.||
8183|101|H|Your dose may need to be gradually decreased.||
8183|102|H|   Tell your doctor if your condition does not get better or if||
8183|103|H|it gets worse after 2 weeks.||
8183|104|B|||
8183|105|S|SIDE EFFECTS:  See also Warning section.||
8183|106|S|   Drowsiness, dizziness, lightheadedness, constipation,||
8183|107|S|weakness, and dry skin may occur. If any of these effects last or||
8183|108|S|get worse, tell your doctor or pharmacist promptly.||
8183|109|S|   To reduce the risk of dizziness and lightheadedness, get up||
8183|110|S|slowly when rising from a sitting or lying position.||
8183|111|S|   Remember that this medication has been prescribed because your||
8183|112|S|doctor has judged that the benefit to you is greater than the||
8183|113|S|risk of side effects. Many people using this medication do not||
8183|114|S|have serious side effects.||
8183|115|S|   Thalidomide may cause possibly severe nerve damage, which may||
8183|116|S|be permanent. This may occur during treatment or after treatment||
8183|117|S|has stopped. Tell your doctor right away if you develop any of||
8183|118|S|the following symptoms: numbness/tingling/pain/burning in the||
8183|119|S|feet or hands, muscle weakness/cramps, feeling of tightness in||
8183|120|S|the feet.||
8183|121|S|   Tell your doctor right away if you have any serious side||
8183|122|S|effects, including: mental/mood changes (such as confusion,||
8183|123|S|anxiety), shaking (tremor), shortness of breath, arm/leg||
8183|124|S|swelling, fast/slow heartbeat, easy bruising/bleeding,||
8183|125|S|black/bloody stools, vomit that contains blood or looks like||
8183|126|S|coffee grounds.||
8183|127|S|   People with multiple myeloma who are treated with this||
8183|128|S|medication may rarely get other cancers (such as acute leukemia).||
8183|129|S|Consult your doctor for more details.||
8183|130|S|   Get medical help right away if you have any very serious side||
8183|131|S|effects, including: seizures.||
8183|132|S|   A very serious allergic reaction to this drug is rare.||
8183|133|S|However, get medical help right away if you notice any symptoms||
8183|134|S|of a serious allergic reaction, including: fever, swollen lymph||
8183|135|S|nodes, rash, itching/swelling (especially of the||
8183|136|S|face/tongue/throat), severe dizziness, trouble breathing.||
8183|137|S|   This is not a complete list of possible side effects. If you||
8183|138|S|notice other effects not listed above, contact your doctor or||
8183|139|S|pharmacist.||
8183|140|S|   In the US -||
8183|141|S|   Call your doctor for medical advice about side effects. You||
8183|142|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8183|143|S|www.fda.gov/medwatch.||
8183|144|S|   In Canada - Call your doctor for medical advice about side||
8183|145|S|effects. You may report side effects to Health Canada at||
8183|146|S|1-866-234-2345.||
8183|147|B|||
8183|148|P|PRECAUTIONS:  Before taking thalidomide, tell your doctor or||
8183|149|P|pharmacist if you are allergic to it; or if you have any other||
8183|150|P|allergies. This product may contain inactive ingredients, which||
8183|151|P|can cause allergic reactions or other problems. Talk to your||
8183|152|P|pharmacist for more details.||
8183|153|P|   Before using this medication, tell your doctor or pharmacist||
8183|154|P|your medical history, especially of: certain blood disorders (low||
8183|155|P|platelet/white blood cell count), numbness/tingling of arms/legs,||
8183|156|P|seizures.||
8183|157|P|   Caution is advised when using this drug in people with HIV||
8183|158|P|because they may be more sensitive to the effects of the drug.||
8183|159|P|While thalidomide is used to treat muscle wasting and other||
8183|160|P|HIV-related conditions, the drug might affect the amount of HIV||
8183|161|P|in your system (viral load). The manufacturer recommends having||
8183|162|P|HIV tests from time to time.||
8183|163|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8183|164|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8183|165|P|machinery, or do anything that needs alertness until you can do||
8183|166|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
8183|167|P|are using marijuana (cannabis).||
8183|168|P|   Since this drug can be absorbed through the skin and lungs and||
8183|169|P|may harm an unborn baby, women who are pregnant or who may become||
8183|170|P|pregnant should not handle this medication or breathe the dust||
8183|171|P|from broken capsules.||
8183|172|P|   Thalidomide must not be used during pregnancy due to the risk||
8183|173|P|of severe birth defects and other serious, sometimes fatal harm||
8183|174|P|to an unborn baby. If you are female and become pregnant or think||
8183|175|P|you may be pregnant, if your period is late or you have unusual||
8183|176|P|menstrual bleeding, or if you stop using 2 forms of birth||
8183|177|P|control, stop taking thalidomide and tell your doctor right away.||
8183|178|P|If you are male and have had unprotected sex with a woman who can||
8183|179|P|become pregnant, or if you think your sexual partner may be||
8183|180|P|pregnant, tell both of your doctors right away. (See also Warning||
8183|181|P|section.)||
8183|182|P|   It is unknown if this drug passes into breast milk. Because of||
8183|183|P|the possible risk to the infant, breastfeeding is not recommended||
8183|184|P|while using this drug. Consult your doctor before breastfeeding.||
8183|185|B|||
8183|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8183|187|I|medications work or increase your risk for serious side effects.||
8183|188|I|This document does not contain all possible drug interactions.||
8183|189|I|Keep a list of all the products you use (including||
8183|190|I|prescription/nonprescription drugs and herbal products) and share||
8183|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
8183|192|I|the dosage of any medicines without your doctor's approval.||
8183|193|I|   Tell your doctor or pharmacist if you also take drugs that||
8183|194|I|cause drowsiness such as: alcohol, marijuana (cannabis), certain||
8183|195|I|antihistamines (such as diphenhydramine), medicine for sleep or||
8183|196|I|anxiety (such as alprazolam, diazepam, zolpidem), muscle||
8183|197|I|relaxants, opioid pain relievers (such as codeine), psychiatric||
8183|198|I|medicines (such as chlorpromazine, risperidone, amitriptyline,||
8183|199|I|trazodone).||
8183|200|I|   Check the labels on all your medicines (such as cough-and-cold||
8183|201|I|products) because they may contain ingredients that cause||
8183|202|I|drowsiness. Ask your pharmacist about using those products||
8183|203|I|safely.||
8183|204|I|   It is very important for women to use 2 forms of effective||
8183|205|I|birth control while taking this medication. Some drugs may cause||
8183|206|I|hormonal birth control (such as pills, patch, ring) to work less||
8183|207|I|well by decreasing the amount of birth control hormones in your||
8183|208|I|body. This effect can result in pregnancy. Examples include||
8183|209|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
8183|210|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
8183|211|I|seizures (such as barbiturates, carbamazepine, felbamate,||
8183|212|I|phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir,||
8183|213|I|nevirapine), among others.||
8183|214|I|   Tell your doctor when you start any new drug, and discuss if||
8183|215|I|you should use reliable backup birth control while using the new||
8183|216|I|drug and for 1 month after stopping the new drug.||
8183|217|B|||
8183|218|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8183|219|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8183|220|O|poison control center right away. US residents can call||
8183|221|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8183|222|O|Symptoms of overdose may include: prolonged sleep.||
8183|223|B|||
8183|224|N|NOTES:  Do not share this medication with others. Do not donate||
8183|225|N|blood, organs, eggs, or sperm while taking thalidomide.||
8183|226|N|   Lab and/or medical tests (such as pregnancy tests, white blood||
8183|227|N|cell/platelet count) should be done while you are taking this||
8183|228|N|medication. Keep all medical and lab appointments. Consult your||
8183|229|N|doctor for more details.||
8183|230|B|||
8183|231|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8183|232|D|remember. If it is more than 12 hours after the missed dose, skip||
8183|233|D|the missed dose. Take your next dose at the regular time. Do not||
8183|234|D|double the dose to catch up.||
8183|235|B|||
8183|236|R|STORAGE:  Store at room temperature away from light and moisture.||
8183|237|R|Keep capsules in the original blister pack until ready to use. Do||
8183|238|R|not store in the bathroom. Keep all medications away from||
8183|239|R|children and pets.||
8183|240|R|   Do not flush medications down the toilet or pour them into a||
8183|241|R|drain unless instructed to do so. Properly discard this product||
8183|242|R|when it is expired or no longer needed. Consult your pharmacist||
8183|243|R|or local waste disposal company.||
8183|244|B|||
8183|245|M|MEDICAL ALERT:  Your condition can cause complications in a||
8183|246|M|medical emergency. For information about enrolling in MedicAlert,||
8183|247|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8183|248|B|||
8183|249|A|Information last revised November 2024.||
8183|250|A|Copyright(c) 2025 First Databank, Inc.||
8183|251|B|||
8185|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8185|002|Z|does NOT have all possible information about this product. This||
8185|003|Z|information does not assure that this product is safe, effective,||
8185|004|Z|or appropriate for you. This information is not individual||
8185|005|Z|medical advice and does not substitute for the advice of your||
8185|006|Z|health care professional. Always ask your health care||
8185|007|Z|professional for complete information about this product and your||
8185|008|Z|specific health needs.||
8185|009|B|||
8185|010|T|FLURANDRENOLIDE TAPE - TOPICAL||
8185|011|F|(flewr-an-DREN-oh-lide)||
8185|012|B|||
8185|013|C|COMMON BRAND NAME(S): Cordran||
8185|014|B|||
8185|015|U|USES:  This medication is used to treat a variety of skin||
8185|016|U|conditions (such as eczema, dermatitis, allergies, rash).||
8185|017|U|Flurandrenolide reduces the swelling, itching, and redness that||
8185|018|U|can occur in these types of conditions. This medication is a||
8185|019|U|medium-strength corticosteroid. The tape acts to protect the||
8185|020|U|treated skin and makes the medication more effective and||
8185|021|U|longer-lasting.||
8185|022|B|||
8185|023|H|HOW TO USE:  Use this medication on the skin only. However, do||
8185|024|H|not use it on the face, groin, or underarms unless directed to do||
8185|025|H|so by your doctor.||
8185|026|H|   Wash and dry your hands before using. Clean and dry the||
8185|027|H|affected area before applying the tape. Measure the proper amount||
8185|028|H|of tape to be used. Tape should always be cut, never torn. Apply||
8185|029|H|the tape to the skin and press on the tape to keep it in place.||
8185|030|H|Remove the tape after 12 hours and replace with fresh tape unless||
8185|031|H|directed otherwise by your doctor. Do not use other bandages or||
8185|032|H|cover/wrap the area unless directed to do so by your doctor.||
8185|033|H|   After applying the medication, wash your hands, unless you are||
8185|034|H|using this medication to treat the hands. Use carefully if||
8185|035|H|applying to the face. Avoid contact with the eyes because this||
8185|036|H|may worsen or cause glaucoma. Also, avoid applying this||
8185|037|H|medication in the nose or mouth. If you get the medication in||
8185|038|H|your eyes, nose, or mouth, remove the tape and rinse with plenty||
8185|039|H|of water.||
8185|040|H|   Use this medication only for the condition prescribed. Do not||
8185|041|H|use more tape than prescribed, apply more often, or use for||
8185|042|H|longer than prescribed. Your condition will not clear faster, but||
8185|043|H|your risk of side effects may be increased.||
8185|044|H|   Tell your doctor if your condition lasts or gets worse after 2||
8185|045|H|weeks.||
8185|046|B|||
8185|047|S|SIDE EFFECTS:  Stinging, burning, itching, irritation, dryness,||
8185|048|S|or redness of the skin may occur when the tape is first applied||
8185|049|S|to the skin. These effects should disappear in a few days as your||
8185|050|S|body adjusts to the medication. If any of these effects last or||
8185|051|S|get worse, tell your doctor or pharmacist promptly.||
8185|052|S|   Remember that this medication has been prescribed because your||
8185|053|S|doctor has judged that the benefit to you is greater than the||
8185|054|S|risk of side effects. Many people using this medication do not||
8185|055|S|have serious side effects.||
8185|056|S|   Tell your doctor right away if you have any serious side||
8185|057|S|effects, including: stretch marks, skin thinning/discoloration,||
8185|058|S|acne, too much hair growth, small red bumps on the skin||
8185|059|S|(folliculitis).||
8185|060|S|   Skin infections can become worse when using this medication.||
8185|061|S|Notify your doctor promptly if redness, swelling, or irritation||
8185|062|S|does not improve.||
8185|063|S|   Rarely, it is possible this medication will be absorbed from||
8185|064|S|the skin into the bloodstream. This can lead to side effects of||
8185|065|S|too much corticosteroid. These side effects are more likely in||
8185|066|S|children, and in people who use this medication for a long time||
8185|067|S|or over large areas of the skin. Tell your doctor right away if||
8185|068|S|any of the following side effects occur: unusual/extreme||
8185|069|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
8185|070|S|thirst/urination, vision problems.||
8185|071|S|   A very serious allergic reaction to this drug is rare.||
8185|072|S|However, get medical help right away if you notice any symptoms||
8185|073|S|of a serious allergic reaction, including: rash, itching/swelling||
8185|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8185|075|S|breathing.||
8185|076|S|   This is not a complete list of possible side effects. If you||
8185|077|S|notice other effects not listed above, contact your doctor or||
8185|078|S|pharmacist.||
8185|079|S|   In the US -||
8185|080|S|   Call your doctor for medical advice about side effects. You||
8185|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8185|082|S|www.fda.gov/medwatch.||
8185|083|S|   In Canada - Call your doctor for medical advice about side||
8185|084|S|effects. You may report side effects to Health Canada at||
8185|085|S|1-866-234-2345.||
8185|086|B|||
8185|087|P|PRECAUTIONS:  Before using flurandrenolide, tell your doctor or||
8185|088|P|pharmacist if you are allergic to it; or to other corticosteroids||
8185|089|P|(such as hydrocortisone, prednisone); or if you have any other||
8185|090|P|allergies. This product may contain inactive ingredients, which||
8185|091|P|can cause allergic reactions or other problems. Talk to your||
8185|092|P|pharmacist for more details.||
8185|093|P|   Before using this medication, tell your doctor or pharmacist||
8185|094|P|your medical history, especially of: poor blood circulation,||
8185|095|P|diabetes, immune system problems, other skin conditions (such as||
8185|096|P|rosacea, perioral dermatitis).||
8185|097|P|   Do not use if there is an infection or sore in the area to be||
8185|098|P|treated.||
8185|099|P|   Rarely, using corticosteroid medications for a long time or||
8185|100|P|over large areas of skin can make it more difficult for your body||
8185|101|P|to respond to physical stress. Before having surgery or emergency||
8185|102|P|treatment, or if you get a serious illness/injury, tell your||
8185|103|P|doctor or dentist that you are using this medication or have used||
8185|104|P|this medication within the past few months.||
8185|105|P|   Though it is unlikely, this medication may temporarily slow||
8185|106|P|down a child's growth if used for a long time. See the doctor||
8185|107|P|regularly so your child's height can be checked.||
8185|108|P|   During pregnancy, this medication should be used only when||
8185|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
8185|110|P|   It is unknown if this drug passes into breast milk when||
8185|111|P|applied to the skin. Similar medications pass into breast milk||
8185|112|P|when taken by mouth. Consult your doctor before breastfeeding.||
8185|113|B|||
8185|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8185|115|I|medications work or increase your risk for serious side effects.||
8185|116|I|This document does not contain all possible drug interactions.||
8185|117|I|Keep a list of all the products you use (including||
8185|118|I|prescription/nonprescription drugs and herbal products) and share||
8185|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
8185|120|I|the dosage of any medicines without your doctor's approval.||
8185|121|B|||
8185|122|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8185|123|O|has overdosed and has serious symptoms such as passing out or||
8185|124|O|trouble breathing, call 911. Otherwise, call a poison control||
8185|125|O|center right away. US residents can call 1-800-222-1222. Canada||
8185|126|O|residents can call 1-844-764-7669.||
8185|127|B|||
8185|128|N|NOTES:  Do not share this medication with others. This medication||
8185|129|N|has been prescribed for your current condition only. Do not use||
8185|130|N|it later for another skin problem unless told to do so by your||
8185|131|N|doctor. A different medication may be necessary in that case.||
8185|132|N|   Lab and/or medical tests (such as adrenal gland function) may||
8185|133|N|be done while you are using this medication, especially if you||
8185|134|N|use this drug for an extended period of time or apply it over||
8185|135|N|large areas of the body. Keep all medical and lab appointments.||
8185|136|N|Consult your doctor for more details.||
8185|137|B|||
8185|138|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8185|139|D|If it is near the time of the next dose, skip the missed dose.||
8185|140|D|Use your next dose at the regular time. Do not double the dose to||
8185|141|D|catch up.||
8185|142|B|||
8185|143|R|STORAGE:  Store at room temperature. Keep all medications away||
8185|144|R|from children and pets.||
8185|145|R|   Do not flush medications down the toilet or pour them into a||
8185|146|R|drain unless instructed to do so. Properly discard this product||
8185|147|R|when it is expired or no longer needed. Consult your pharmacist||
8185|148|R|or local waste disposal company.||
8185|149|B|||
8185|150|A|Information last revised January 2025.||
8185|151|A|Copyright(c) 2025 First Databank, Inc.||
8185|152|B|||
8186|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8186|002|Z|does NOT have all possible information about this product. This||
8186|003|Z|information does not assure that this product is safe, effective,||
8186|004|Z|or appropriate for you. This information is not individual||
8186|005|Z|medical advice and does not substitute for the advice of your||
8186|006|Z|health care professional. Always ask your health care||
8186|007|Z|professional for complete information about this product and your||
8186|008|Z|specific health needs.||
8186|009|B|||
8186|010|T|KETOPROFEN - ORAL||
8186|011|F|(KEE-toe-PROE-fen)||
8186|012|B|||
8186|013|C|COMMON BRAND NAME(S): Orudis||
8186|014|B|||
8186|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
8186|016|W|ketoprofen) may rarely increase the risk of a heart attack or||
8186|017|W|stroke. This effect can happen at any time while taking this drug||
8186|018|W|but is more likely if you take it for a long time. The risk may||
8186|019|W|be greater in older adults or if you have heart disease or||
8186|020|W|increased risk for heart disease (for example, due to smoking,||
8186|021|W|family history of heart disease, or conditions such as high blood||
8186|022|W|pressure or diabetes). Do not take this drug right before or||
8186|023|W|after heart bypass surgery (CABG).||
8186|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
8186|025|W|bleeding from the stomach or intestines. This effect can occur||
8186|026|W|without warning symptoms at any time while taking this drug.||
8186|027|W|Older adults may be at higher risk for this effect.||
8186|028|W|   Stop taking ketoprofen and get medical help right away if you||
8186|029|W|notice any of these rare but serious side effects:||
8186|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
8186|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
8186|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
8186|033|W|side of the body, trouble speaking, sudden vision changes.||
8186|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
8186|035|W|of taking this drug.||
8186|036|B|||
8186|037|U|USES:  See also Warning section.||
8186|038|U|   Ketoprofen is used to relieve pain from various conditions||
8186|039|U|such as dental pain, menstrual cramps, and muscle aches. It is||
8186|040|U|also used to reduce pain, swelling, and joint stiffness from||
8186|041|U|arthritis.||
8186|042|U|   Ketoprofen is known as a nonsteroidal anti-inflammatory drug||
8186|043|U|(NSAID). It works by blocking your body's production of certain||
8186|044|U|natural substances that cause inflammation. This effect helps to||
8186|045|U|decrease swelling, pain, or fever.||
8186|046|U|   If you are treating a chronic condition such as arthritis, ask||
8186|047|U|your doctor about non-drug treatments and/or using other||
8186|048|U|medications to treat your pain.||
8186|049|B|||
8186|050|V|OTHER USES:  This section contains uses of this drug that are not||
8186|051|V|listed in the approved professional labeling for the drug but||
8186|052|V|that may be prescribed by your health care professional. Use this||
8186|053|V|drug for a condition that is listed in this section only if it||
8186|054|V|has been so prescribed by your health care professional.||
8186|055|V|   This medication may also be used for gout attacks and migraine||
8186|056|V|headaches.||
8186|057|B|||
8186|058|H|HOW TO USE:  Read the Medication Guide provided by your||
8186|059|H|pharmacist before you start taking ketoprofen and each time you||
8186|060|H|get a refill. If you have any questions, ask your doctor or||
8186|061|H|pharmacist.||
8186|062|H|   Take this medication by mouth as directed by your doctor,||
8186|063|H|usually 3 to 4 times a day or as needed. Take this medication||
8186|064|H|with a full glass of water (8 ounces/240 milliliters) unless your||
8186|065|H|doctor directs you otherwise. Do not lie down for at least 10||
8186|066|H|minutes after taking this medication. If stomach upset occurs||
8186|067|H|while taking this medication, it may be taken with food, milk, or||
8186|068|H|an antacid.||
8186|069|H|   The dosage is based on your medical condition and response to||
8186|070|H|treatment. To reduce your risk of stomach bleeding and other side||
8186|071|H|effects, take this medication at the lowest effective dose for||
8186|072|H|the shortest possible time. Do not increase your dose or use this||
8186|073|H|drug more often or for longer than prescribed. Discuss the risks||
8186|074|H|and benefits with your doctor or pharmacist.||
8186|075|H|   For certain conditions (such as arthritis), it may take up to||
8186|076|H|2 weeks of taking this drug regularly until you get the full||
8186|077|H|benefit. If you use this medication for migraine headache and the||
8186|078|H|pain is not relieved, or if it gets worse after the first dose,||
8186|079|H|tell your doctor right away.||
8186|080|H|   If you are taking this drug "as needed" (not on a regular||
8186|081|H|schedule), remember that pain medications work best if they are||
8186|082|H|used as the first signs of pain occur. If you wait until the pain||
8186|083|H|has worsened, the medicine may not work as well.||
8186|084|H|   Tell your doctor if your condition lasts or gets worse.||
8186|085|B|||
8186|086|S|SIDE EFFECTS:  See also Warning section.||
8186|087|S|   Upset stomach, nausea, constipation, diarrhea, gas, dizziness,||
8186|088|S|drowsiness, blurred vision, or headache may occur. If any of||
8186|089|S|these effects last or get worse, tell your doctor or pharmacist||
8186|090|S|promptly.||
8186|091|S|   Remember that this medication has been prescribed because your||
8186|092|S|doctor has judged that the benefit to you is greater than the||
8186|093|S|risk of side effects. Many people using this medication do not||
8186|094|S|have serious side effects.||
8186|095|S|   This medication may raise your blood pressure. Check your||
8186|096|S|blood pressure regularly and tell your doctor if the results are||
8186|097|S|high.||
8186|098|S|   Tell your doctor right away if you have any serious side||
8186|099|S|effects, including: hearing changes (such as ringing in the||
8186|100|S|ears), mental/mood changes, easy bleeding/bruising,||
8186|101|S|difficult/painful swallowing, signs of kidney problems (such as||
8186|102|S|change in the amount of urine, pink/bloody urine), symptoms of||
8186|103|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
8186|104|S|unusual/sudden weight gain).||
8186|105|S|   Ketoprofen may rarely cause serious (possibly fatal) liver||
8186|106|S|disease. Get medical help right away if you have any symptoms of||
8186|107|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
8186|108|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
8186|109|S|urine.||
8186|110|S|   A very serious allergic reaction to this drug is rare.||
8186|111|S|However, get medical help right away if you notice any symptoms||
8186|112|S|of a serious allergic reaction, including: fever, swollen lymph||
8186|113|S|nodes, rash, itching/swelling (especially of the||
8186|114|S|face/tongue/throat), severe dizziness, trouble breathing.||
8186|115|S|   This is not a complete list of possible side effects. If you||
8186|116|S|notice other effects not listed above, contact your doctor or||
8186|117|S|pharmacist.||
8186|118|S|   In the US -||
8186|119|S|   Call your doctor for medical advice about side effects. You||
8186|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8186|121|S|www.fda.gov/medwatch.||
8186|122|S|   In Canada - Call your doctor for medical advice about side||
8186|123|S|effects. You may report side effects to Health Canada at||
8186|124|S|1-866-234-2345.||
8186|125|B|||
8186|126|P|PRECAUTIONS:  See also Warning section.||
8186|127|P|   Before taking ketoprofen, tell your doctor or pharmacist if||
8186|128|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
8186|129|P|ibuprofen, naproxen, celecoxib); or if you have any other||
8186|130|P|allergies. This product may contain inactive ingredients, which||
8186|131|P|can cause allergic reactions or other problems. Talk to your||
8186|132|P|pharmacist for more details.||
8186|133|P|   Before using this medication, tell your doctor or pharmacist||
8186|134|P|your medical history, especially of: asthma (including a history||
8186|135|P|of worsening breathing after taking aspirin or other NSAIDs),||
8186|136|P|bleeding/clotting problems, blood disorders (such as anemia),||
8186|137|P|growths in the nose (nasal polyps), heart disease (such as||
8186|138|P|previous heart attack), high blood pressure, liver disease,||
8186|139|P|stroke, swelling (edema, fluid retention),||
8186|140|P|stomach/intestinal/esophagus problems (such as bleeding,||
8186|141|P|heartburn, ulcers).||
8186|142|P|   Kidney problems can sometimes occur with the use of NSAID||
8186|143|P|medications, including ketoprofen. Problems are more likely to||
8186|144|P|occur if you are dehydrated, have heart failure or kidney||
8186|145|P|disease, are an older adult, or if you take certain medications||
8186|146|P|(see also Drug Interactions section). Drink plenty of fluids as||
8186|147|P|directed by your doctor to prevent dehydration and tell your||
8186|148|P|doctor right away if you have pink/bloody urine or any unusual||
8186|149|P|change in the amount of urine.||
8186|150|P|   This drug may make you dizzy or drowsy or cause blurred||
8186|151|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
8186|152|P|Do not drive, use machinery, or do anything that needs alertness||
8186|153|P|until you can do it safely. Limit alcoholic beverages. Talk to||
8186|154|P|your doctor if you are using marijuana (cannabis).||
8186|155|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
8186|156|P|and tobacco, especially when combined with this medicine, may||
8186|157|P|increase your risk for stomach bleeding. Limit alcohol and stop||
8186|158|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
8186|159|P|may safely drink.||
8186|160|P|   This medication may make you more sensitive to the sun. Limit||
8186|161|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8186|162|P|sunscreen and wear protective clothing when outdoors. Tell your||
8186|163|P|doctor right away if you get sunburned or have skin||
8186|164|P|blisters/redness.||
8186|165|P|   Before having surgery, tell your doctor or dentist about all||
8186|166|P|the products you use (including prescription drugs,||
8186|167|P|nonprescription drugs, and herbal products).||
8186|168|P|   Older adults may be at greater risk for stomach/intestinal||
8186|169|P|bleeding, kidney problems, heart attack, and stroke while using||
8186|170|P|this drug.||
8186|171|P|   Before using this medication, women of childbearing age should||
8186|172|P|talk with their doctor(s) about the benefits and risks. Tell your||
8186|173|P|doctor if you are pregnant or if you plan to become pregnant.||
8186|174|P|This medication may harm an unborn baby and cause problems with||
8186|175|P|normal labor/delivery. It is not recommended for use in pregnancy||
8186|176|P|from 20 weeks until delivery. If your doctor decides that you||
8186|177|P|need to use this medication between 20 and 30 weeks of pregnancy,||
8186|178|P|you should use the lowest effective dose for the shortest||
8186|179|P|possible time. You should not use this medication after 30 weeks||
8186|180|P|of pregnancy.||
8186|181|P|   This drug passes into breast milk. Consult your doctor before||
8186|182|P|breastfeeding.||
8186|183|B|||
8186|184|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8186|185|I|medications work or increase your risk for serious side effects.||
8186|186|I|This document does not contain all possible drug interactions.||
8186|187|I|Keep a list of all the products you use (including||
8186|188|I|prescription/nonprescription drugs and herbal products) and share||
8186|189|I|it with your doctor and pharmacist. Do not start, stop, or change||
8186|190|I|the dosage of any medicines without your doctor's approval.||
8186|191|I|   Some products that may interact with this drug are: aliskiren,||
8186|192|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
8186|193|I|receptor blockers (such as losartan, valsartan), cidofovir,||
8186|194|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
8186|195|I|methotrexate, "water pills" (diuretics such as furosemide).||
8186|196|I|   Other medications can affect the removal of ketoprofen from||
8186|197|I|your body, which may affect how ketoprofen works. An example is||
8186|198|I|probenecid, among others.||
8186|199|I|   This medication may increase the risk of bleeding when taken||
8186|200|I|with other drugs that also may cause bleeding. Examples include||
8186|201|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
8186|202|I|dabigatran/enoxaparin/warfarin, among others.||
8186|203|I|   Check all prescription and nonprescription medicine labels||
8186|204|I|carefully since many medications contain pain relievers/fever||
8186|205|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
8186|206|I|naproxen). These drugs are similar to ketoprofen and may increase||
8186|207|I|your risk of side effects if taken together. However, if your||
8186|208|I|doctor has told you to take low-dose aspirin to prevent heart||
8186|209|I|attack or stroke (usually 81-162 milligrams a day), you should||
8186|210|I|keep taking the aspirin unless your doctor tells you not to. Ask||
8186|211|I|your doctor or pharmacist for more details.||
8186|212|B|||
8186|213|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8186|214|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8186|215|O|poison control center right away. US residents can call||
8186|216|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8186|217|O|Symptoms of overdose may include: severe stomach pain,||
8186|218|O|slow/shallow breathing, extreme drowsiness, seizure.||
8186|219|B|||
8186|220|N|NOTES:  Do not share this medication with others.||
8186|221|N|   Lab and/or medical tests (such as complete blood count,||
8186|222|N|liver/kidney function, blood pressure) may be done while you are||
8186|223|N|using this medication. Keep all medical and lab appointments.||
8186|224|N|Consult your doctor for more details.||
8186|225|N|   Lifestyle changes (such as weight loss if needed,||
8186|226|N|strengthening/conditioning exercises) may help improve your||
8186|227|N|flexibility and joint function. Consult your doctor for specific||
8186|228|N|instructions.||
8186|229|B|||
8186|230|D|MISSED DOSE:  If you are taking this medication on a regular||
8186|231|D|schedule (not just "as needed") and you miss a dose, take it as||
8186|232|D|soon as you remember. If it is near the time of the next dose,||
8186|233|D|skip the missed dose. Take your next dose at the regular time. Do||
8186|234|D|not double the dose to catch up.||
8186|235|B|||
8186|236|R|STORAGE:  Store at room temperature away from light and moisture.||
8186|237|R|Do not store in the bathroom. Keep all medications away from||
8186|238|R|children and pets.||
8186|239|R|   Do not flush medications down the toilet or pour them into a||
8186|240|R|drain unless instructed to do so. Properly discard this product||
8186|241|R|when it is expired or no longer needed. Consult your pharmacist||
8186|242|R|or local waste disposal company.||
8186|243|B|||
8186|244|A|Information last revised August 2025.||
8186|245|A|Copyright(c) 2025 First Databank, Inc.||
8186|246|B|||
8187|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8187|002|Z|does NOT have all possible information about this product. This||
8187|003|Z|information does not assure that this product is safe, effective,||
8187|004|Z|or appropriate for you. This information is not individual||
8187|005|Z|medical advice and does not substitute for the advice of your||
8187|006|Z|health care professional. Always ask your health care||
8187|007|Z|professional for complete information about this product and your||
8187|008|Z|specific health needs.||
8187|009|B|||
8187|010|T|CYSTEAMINE - ORAL||
8187|011|F|(sis-TAY-uh-meen)||
8187|012|B|||
8187|013|C|COMMON BRAND NAME(S): Cystagon||
8187|014|B|||
8187|015|U|USES:  This medication is used to help preserve kidney function||
8187|016|U|and manage kidney damage and other problems in people with an||
8187|017|U|inherited disorder that causes build-up of a certain natural||
8187|018|U|substance (cystine) in the body (nephropathic cystinosis).||
8187|019|U|Cystine build-up can cause problems such as kidney problems, slow||
8187|020|U|growth, weak bones, and eye problems. Cysteamine helps the body||
8187|021|U|get rid of cystine.||
8187|022|B|||
8187|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8187|024|H|from your pharmacist before you start using cysteamine and each||
8187|025|H|time you get a refill. If you have any questions, consult your||
8187|026|H|doctor or pharmacist.||
8187|027|H|   Take this medication by mouth as directed by your doctor,||
8187|028|H|usually 4 times a day.||
8187|029|H|   Take this medication with food or just after a meal to reduce||
8187|030|H|stomach upset. Do not give the whole capsule to children younger||
8187|031|H|than 6 years. Instead, open the capsule and sprinkle the contents||
8187|032|H|onto soft food such as applesauce or mashed potatoes. Eat all of||
8187|033|H|the mixture right away. Do not prepare a supply for future use.||
8187|034|H|   The dosage is based on weight, medical condition, and response||
8187|035|H|to treatment. Your doctor may direct you to take a low dose at||
8187|036|H|first, gradually increasing the dose to lower the chance of side||
8187|037|H|effects such as upset stomach. Your doctor will adjust your dose||
8187|038|H|based on your cystine levels to find the best dose for you.||
8187|039|H|Follow your doctor's directions carefully.||
8187|040|H|   Take this medication regularly in order to get the most||
8187|041|H|benefit from it. To help you remember, take it at the same times||
8187|042|H|each day.||
8187|043|B|||
8187|044|S|SIDE EFFECTS:  Nausea, vomiting, fever, loss of appetite,||
8187|045|S|tiredness, drowsiness, and diarrhea may occur. If any of these||
8187|046|S|effects last or get worse, tell your doctor or pharmacist||
8187|047|S|promptly.||
8187|048|S|   Remember that this medication has been prescribed because your||
8187|049|S|doctor has judged that the benefit to you is greater than the||
8187|050|S|risk of side effects. Many people using this medication do not||
8187|051|S|have serious side effects.||
8187|052|S|   Tell your doctor right away if you have any serious side||
8187|053|S|effects, including: mental/mood changes (such as depression),||
8187|054|S|deep sleep, seizures, unusual tiredness, headache, hearing||
8187|055|S|problems (such as buzzing/ringing in the ears), dizziness,||
8187|056|S|eye/vision problems (such as blurred vision, loss of vision, eye||
8187|057|S|pain), skin problems (such as thinning of the skin, stretch||
8187|058|S|marks, purple bleeding patches on the elbows), bone problems||
8187|059|S|(such as bone/joint/back pain, leg pain, broken bones).||
8187|060|S|   Get medical help right away if you have any very serious side||
8187|061|S|effects, including: black/bloody stools, stomach/abdominal pain,||
8187|062|S|vomit that looks like coffee grounds.||
8187|063|S|   Cysteamine can commonly cause a rash that may not be serious.||
8187|064|S|However, you may not be able to tell it apart from a rare rash||
8187|065|S|that could be a sign of a severe reaction. Get medical help right||
8187|066|S|away if you or your child develops any rash.||
8187|067|S|   A very serious allergic reaction to this drug is rare.||
8187|068|S|However, get medical help right away if you notice any symptoms||
8187|069|S|of a serious allergic reaction, including: rash, itching/swelling||
8187|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8187|071|S|breathing.||
8187|072|S|   This is not a complete list of possible side effects. If you||
8187|073|S|notice other effects not listed above, contact your doctor or||
8187|074|S|pharmacist.||
8187|075|S|   In the US -||
8187|076|S|   Call your doctor for medical advice about side effects. You||
8187|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8187|078|S|www.fda.gov/medwatch.||
8187|079|S|   In Canada - Call your doctor for medical advice about side||
8187|080|S|effects. You may report side effects to Health Canada at||
8187|081|S|1-866-234-2345.||
8187|082|B|||
8187|083|P|PRECAUTIONS:  Before taking cysteamine, tell your doctor or||
8187|084|P|pharmacist if you are allergic to it; or to penicillamine; or if||
8187|085|P|you have any other allergies. This product may contain inactive||
8187|086|P|ingredients, which can cause allergic reactions or other||
8187|087|P|problems. Talk to your pharmacist for more details.||
8187|088|P|   Before using this medication, tell your doctor or pharmacist||
8187|089|P|your or your child's medical history, especially of: liver||
8187|090|P|disease, stomach/gut problems (such as bleeding, ulcers).||
8187|091|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8187|092|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8187|093|P|machinery, or do anything that needs alertness until you can do||
8187|094|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8187|095|P|are using marijuana (cannabis).||
8187|096|P|   During pregnancy, this medication should be used only when||
8187|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
8187|098|P|   It is unknown if this medication passes into breast milk.||
8187|099|P|Consult your doctor before breastfeeding.||
8187|100|B|||
8187|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8187|102|I|medications work or increase your risk for serious side effects.||
8187|103|I|This document does not contain all possible drug interactions.||
8187|104|I|Keep a list of all the products you use (including||
8187|105|I|prescription/nonprescription drugs and herbal products) and share||
8187|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
8187|107|I|the dosage of any medicines without your doctor's approval.||
8187|108|B|||
8187|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8187|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8187|111|O|poison control center right away. US residents can call||
8187|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8187|113|B|||
8187|114|N|NOTES:  Do not share this medication with others.||
8187|115|N|   Lab and/or medical tests (such as cystine levels, complete||
8187|116|N|blood count, blood mineral levels, kidney/liver function) should||
8187|117|N|be done while you are taking this medication. Keep all medical||
8187|118|N|and lab appointments. Consult your doctor for more details.||
8187|119|B|||
8187|120|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8187|121|D|remember. If it is less than 2 hours before the next dose, skip||
8187|122|D|the missed dose. Take your next dose at the regular time. Do not||
8187|123|D|double the dose to catch up.||
8187|124|B|||
8187|125|R|STORAGE:  Store at room temperature away from light and moisture.||
8187|126|R|Do not store in the bathroom. Keep all medications away from||
8187|127|R|children and pets.||
8187|128|R|   Do not flush medications down the toilet or pour them into a||
8187|129|R|drain unless instructed to do so. Properly discard this product||
8187|130|R|when it is expired or no longer needed. Consult your pharmacist||
8187|131|R|or local waste disposal company.||
8187|132|B|||
8187|133|A|Information last revised January 2025.||
8187|134|A|Copyright(c) 2025 First Databank, Inc.||
8187|135|B|||
8193|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8193|002|Z|does NOT have all possible information about this product. This||
8193|003|Z|information does not assure that this product is safe, effective,||
8193|004|Z|or appropriate for you. This information is not individual||
8193|005|Z|medical advice and does not substitute for the advice of your||
8193|006|Z|health care professional. Always ask your health care||
8193|007|Z|professional for complete information about this product and your||
8193|008|Z|specific health needs.||
8193|009|B|||
8193|010|T|IMIQUIMOD - TOPICAL||
8193|011|F|(im-I-kwi-mod)||
8193|012|B|||
8193|013|C|COMMON BRAND NAME(S): Aldara||
8193|014|B|||
8193|015|U|USES:  This medication is used to treat certain types of growths||
8193|016|U|on the skin. These are precancerous growths (actinic keratoses),||
8193|017|U|a certain type of skin cancer (superficial basal cell carcinoma),||
8193|018|U|and warts on the outside of the genitals/anus. Treating these||
8193|019|U|conditions can decrease complications from them. Imiquimod||
8193|020|U|belongs to a group of drugs called immune response modifiers. It||
8193|021|U|is believed to work by helping to activate your immune system to||
8193|022|U|fight these abnormal skin growths.||
8193|023|U|   This product is not recommended for use on children under 12||
8193|024|U|years of age unless specifically directed by your doctor.||
8193|025|B|||
8193|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8193|027|H|from your pharmacist before you start using imiquimod and each||
8193|028|H|time you get a refill. If you have any questions, ask your doctor||
8193|029|H|or pharmacist.||
8193|030|H|   Use this medication on the skin only. Apply this medication to||
8193|031|H|the affected area(s) as directed by your doctor, usually just||
8193|032|H|before you go to sleep for the night. If you are using the||
8193|033|H|single-use packets, use a new packet for each dose. If you are||
8193|034|H|using the pump, prime the pump as directed before using it for||
8193|035|H|the first time.||
8193|036|H|   Before applying, wash your hands and the area to be treated||
8193|037|H|with mild soap and water. Dry the area well. Apply a thin layer||
8193|038|H|of medication on the affected area(s) as directed and rub in.||
8193|039|H|Wash your hands with soap and water after each application. Do||
8193|040|H|not cover the treated area with bandages or waterproof coverings.||
8193|041|H|However, you may cover the area with cotton gauze, or wear cotton||
8193|042|H|underwear if treating the genital area. Leave the cream on||
8193|043|H|overnight, usually for about 8 hours if treating actinic||
8193|044|H|keratoses or basal cell carcinoma, or 6 to 10 hours for warts. Do||
8193|045|H|not shower or bathe during this time. In the morning, wash the||
8193|046|H|treated area with soap and water to remove the cream. Do not||
8193|047|H|leave imiquimod cream on longer than prescribed.||
8193|048|H|   The dosage and length of treatment is based on your medical||
8193|049|H|condition and response to treatment. When treating actinic||
8193|050|H|keratoses, this medication is usually applied twice a week for 16||
8193|051|H|weeks. When treating superficial basal cell carcinoma, this||
8193|052|H|medication is usually applied 5 times a week for 6 weeks. When||
8193|053|H|treating warts, this medication is usually applied 3 times a week||
8193|054|H|for up to 16 weeks. Use this medication regularly to get the most||
8193|055|H|benefit from it. To help you remember, mark your calendar with a||
8193|056|H|reminder.||
8193|057|H|   Do not apply this medication to broken skin (such as open||
8193|058|H|wounds, infected areas, rash, burns). Also, do not apply this||
8193|059|H|medication in the eyes, nose, mouth, rectum, or vagina. If you||
8193|060|H|get this medication in those areas, flush with plenty of water.||
8193|061|H|If irritation occurs, contact your doctor right away.||
8193|062|H|   Tell your doctor if your condition lasts or gets worse, or if||
8193|063|H|new growths appear during treatment.||
8193|064|B|||
8193|065|S|SIDE EFFECTS:  Treatment area reactions may include redness,||
8193|066|S|swelling, itching, burning, pain/tenderness, thickening/hardening||
8193|067|S|of the skin, peeling/flaking/scabbing/crusting, or leaking a||
8193|068|S|clear fluid. Also, changes in skin color may occur and may not go||
8193|069|S|away. If any of these effects last or get worse, tell your doctor||
8193|070|S|or pharmacist promptly.||
8193|071|S|   If the skin reaction is severe (bleeding, formation of||
8193|072|S|sores/blisters/ulcers), imiquimod may need to be temporarily||
8193|073|S|stopped so that the skin can heal. Follow your doctor's||
8193|074|S|directions.||
8193|075|S|   Runny/stuffy nose, cough, diarrhea, nausea, and back pain may||
8193|076|S|also occur. If any of these effects last or get worse, tell your||
8193|077|S|doctor or pharmacist promptly.||
8193|078|S|   Remember that this medication has been prescribed because your||
8193|079|S|doctor has judged that the benefit to you is greater than the||
8193|080|S|risk of side effects. Many people using this medication do not||
8193|081|S|have serious side effects.||
8193|082|S|   Tell your doctor right away if you have any serious side||
8193|083|S|effects, including: flu-like symptoms (such as fever, tiredness,||
8193|084|S|muscle aches), swollen lymph nodes, new unusual skin||
8193|085|S|growths/changes, chest pain, trouble urinating.||
8193|086|S|   A very serious allergic reaction to this drug is rare.||
8193|087|S|However, get medical help right away if you notice any symptoms||
8193|088|S|of a serious allergic reaction, including: rash, itching/swelling||
8193|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8193|090|S|breathing.||
8193|091|S|   This is not a complete list of possible side effects. If you||
8193|092|S|notice other effects not listed above, contact your doctor or||
8193|093|S|pharmacist.||
8193|094|S|   In the US -||
8193|095|S|   Call your doctor for medical advice about side effects. You||
8193|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8193|097|S|www.fda.gov/medwatch.||
8193|098|S|   In Canada - Call your doctor for medical advice about side||
8193|099|S|effects. You may report side effects to Health Canada at||
8193|100|S|1-866-234-2345.||
8193|101|B|||
8193|102|P|PRECAUTIONS:  Before using imiquimod, tell your doctor or||
8193|103|P|pharmacist if you are allergic to it; or if you have any other||
8193|104|P|allergies. This product may contain inactive ingredients, which||
8193|105|P|can cause allergic reactions or other problems. Talk to your||
8193|106|P|pharmacist for more details.||
8193|107|P|   Before using this medication, tell your doctor or pharmacist||
8193|108|P|your medical history, especially of: immune system problems.||
8193|109|P|   This medication may make you more sensitive to the sun. Limit||
8193|110|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8193|111|P|sunscreen and wear protective clothing when outdoors. Do not||
8193|112|P|apply this medication onto sunburned skin. Tell your doctor right||
8193|113|P|away if you get sunburned or have skin blisters/redness.||
8193|114|P|   Genital/anal warts are caused by a virus called human||
8193|115|P|papillomavirus (HPV). Since imiquimod does not destroy the virus||
8193|116|P|but only helps to eliminate the wart, new warts may form, even||
8193|117|P|while you are being treated. You may also be able to infect any||
8193|118|P|sexual partner who comes into contact with the areas of skin||
8193|119|P|infected with HPV.||
8193|120|P|   To reduce the risk of spreading HPV to others, always use||
8193|121|P|effective barrier protections (such as latex or polyurethane||
8193|122|P|condoms, dental dams) during all sexual activity. Consult your||
8193|123|P|doctor or pharmacist for more details.||
8193|124|P|   During treatment of genital/anal warts, avoid all sexual||
8193|125|P|contact while the cream is on the skin. Condoms, dental dams, and||
8193|126|P|diaphragms may be weakened by the cream, so they may not work as||
8193|127|P|well to prevent pregnancy or spreading of HPV or HIV.||
8193|128|P|   During pregnancy, this medication should be used only when||
8193|129|P|clearly needed. Discuss the risks and benefits with your doctor.||
8193|130|P|   It is unknown if this drug passes into breast milk. Consult||
8193|131|P|your doctor before breastfeeding.||
8193|132|B|||
8193|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8193|134|I|medications work or increase your risk for serious side effects.||
8193|135|I|This document does not contain all possible drug interactions.||
8193|136|I|Keep a list of all the products you use (including||
8193|137|I|prescription/nonprescription drugs and herbal products) and share||
8193|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
8193|139|I|the dosage of any medicines without your doctor's approval.||
8193|140|B|||
8193|141|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8193|142|O|has overdosed and has serious symptoms such as passing out or||
8193|143|O|trouble breathing, call 911. Otherwise, call a poison control||
8193|144|O|center right away. US residents can call 1-800-222-1222. Canada||
8193|145|O|residents can call 1-844-764-7669.||
8193|146|B|||
8193|147|N|NOTES:  Do not share this medication with others.||
8193|148|N|   Keep all medical appointments.||
8193|149|B|||
8193|150|D|MISSED DOSE:  If you miss a dose, wait until the next night to||
8193|151|D|apply it. Do not double the dose to catch up. Continue with your||
8193|152|D|regular scheduled doses as directed.||
8193|153|B|||
8193|154|R|STORAGE:  Different brands of this medication have different||
8193|155|R|storage needs. Check the product package for instructions on how||
8193|156|R|to store your brand, or ask your pharmacist. Keep all medications||
8193|157|R|away from children and pets.||
8193|158|R|   Do not flush medications down the toilet or pour them into a||
8193|159|R|drain unless instructed to do so. Properly discard this product||
8193|160|R|when it is expired or no longer needed. Consult your pharmacist||
8193|161|R|or local waste disposal company.||
8193|162|B|||
8193|163|A|Information last revised February 2025.||
8193|164|A|Copyright(c) 2025 First Databank, Inc.||
8193|165|B|||
8194|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8194|002|Z|does NOT have all possible information about this product. This||
8194|003|Z|information does not assure that this product is safe, effective,||
8194|004|Z|or appropriate for you. This information is not individual||
8194|005|Z|medical advice and does not substitute for the advice of your||
8194|006|Z|health care professional. Always ask your health care||
8194|007|Z|professional for complete information about this product and your||
8194|008|Z|specific health needs.||
8194|009|B|||
8194|010|T|CODEINE/BUTALBITAL/ACETAMINOPHEN/CAFFEINE - ORAL||
8194|011|F|(KOE-deen/bue-TAL-bi-tal/a-SEET-a-MIN-oh-fen/KAF-een)||
8194|012|B|||
8194|013|C|COMMON BRAND NAME(S): Fioricet with Codeine,||
8194|014|C|Phrenilin with Codeine||
8194|015|B|||
8194|016|W|WARNING:  Codeine has a risk for abuse and addiction, which can||
8194|017|W|lead to overdose and death. Codeine may also cause severe,||
8194|018|W|possibly fatal, breathing problems. To lower your risk, your||
8194|019|W|doctor should have you take the smallest dose of codeine that||
8194|020|W|works, and take it for the shortest possible time. See also How||
8194|021|W|to Use section for more information about addiction.||
8194|022|W|   Ask your doctor or pharmacist if you should have medication||
8194|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
8194|024|W|Teach your family or household members about the signs of an||
8194|025|W|opioid overdose and how to treat it.||
8194|026|W|   The risk for severe breathing problems is higher when you||
8194|027|W|start this medication and after a dose increase, or if you take||
8194|028|W|the wrong dose/strength. Taking this medication with alcohol or||
8194|029|W|other drugs that can cause drowsiness or breathing problems may||
8194|030|W|cause very serious side effects, including death. Also, other||
8194|031|W|medications can affect the removal of codeine from your body,||
8194|032|W|which may affect how codeine works. Be sure you know how to take||
8194|033|W|this medication and what other drugs you should avoid taking with||
8194|034|W|it. See also Drug Interactions section. Get medical help right||
8194|035|W|away if any of these very serious side effects occur:||
8194|036|W|slow/shallow breathing, unusual lightheadedness, severe||
8194|037|W|drowsiness/dizziness, difficulty waking up.||
8194|038|W|   Keep this medicine in a safe place to prevent theft, misuse,||
8194|039|W|or abuse. If someone accidentally swallows this medication, get||
8194|040|W|medical help right away.||
8194|041|W|   One ingredient in this product is acetaminophen. Taking too||
8194|042|W|much acetaminophen may cause serious (possibly fatal) liver||
8194|043|W|disease. Adults should not take more than 4000 milligrams (4||
8194|044|W|grams) of acetaminophen a day. People with liver problems and||
8194|045|W|children should take less acetaminophen. Ask your doctor or||
8194|046|W|pharmacist how much acetaminophen is safe to take.||
8194|047|W|   Do not use with any other drug containing acetaminophen||
8194|048|W|without asking your doctor or pharmacist first. Acetaminophen is||
8194|049|W|in many nonprescription and prescription medications (such as||
8194|050|W|pain/fever drugs or cough-and-cold products). Check the labels on||
8194|051|W|all your medicines to see if they contain acetaminophen, and ask||
8194|052|W|your pharmacist if you are unsure.||
8194|053|W|   Get medical help right away if you take too much acetaminophen||
8194|054|W|(overdose), even if you feel well. Overdose symptoms may include||
8194|055|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
8194|056|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
8194|057|W|   Daily alcohol use, especially when combined with||
8194|058|W|acetaminophen, may damage your liver. Avoid alcohol.||
8194|059|W|   Before using this medication, women of childbearing age should||
8194|060|W|talk with their doctor(s) about the risks and benefits. Tell your||
8194|061|W|doctor if you are pregnant or if you plan to become pregnant.||
8194|062|W|During pregnancy, this medication should be used only when||
8194|063|W|clearly needed. It may slightly increase the risk of birth||
8194|064|W|defects if used during the first two months of pregnancy. Also,||
8194|065|W|using it for a long time or in high doses near the expected||
8194|066|W|delivery date may harm the unborn baby. To lessen the risk, take||
8194|067|W|the smallest effective dose for the shortest possible time.||
8194|068|W|Babies born to mothers who use this drug for a long time may||
8194|069|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
8194|070|W|doctor right away if you notice any symptoms in your newborn baby||
8194|071|W|such as crying that doesn't stop, slow/shallow breathing,||
8194|072|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
8194|073|W|difficulty gaining weight.||
8194|074|W|   Children younger than 18 years should not use products that||
8194|075|W|contain codeine. Some children are more sensitive to codeine and||
8194|076|W|have had very serious (rarely fatal) breathing problems such as||
8194|077|W|slow/shallow breathing (see also Side Effects section). The risk||
8194|078|W|is greater in children who are obese or have breathing problems,||
8194|079|W|or after certain surgeries (including tonsil/adenoid removal).||
8194|080|W|Talk with your doctor or pharmacist about the risks and benefits||
8194|081|W|of this medication.||
8194|082|B|||
8194|083|U|USES:  See also Warning section.||
8194|084|U|   This combination medication is used to treat tension||
8194|085|U|headaches. Codeine is an opioid pain reliever that acts on||
8194|086|U|certain centers in the brain to give you pain relief.||
8194|087|U|Acetaminophen helps to decrease the pain from the headache.||
8194|088|U|Caffeine helps increase the effects of acetaminophen. Butalbital||
8194|089|U|is a sedative which helps to decrease anxiety and cause||
8194|090|U|sleepiness and relaxation.||
8194|091|B|||
8194|092|V|OTHER USES:  This section contains uses of this drug that are not||
8194|093|V|listed in the approved professional labeling for the drug but||
8194|094|V|that may be prescribed by your health care professional. Use this||
8194|095|V|drug for a condition that is listed in this section only if it||
8194|096|V|has been so prescribed by your health care professional.||
8194|097|V|   This drug may also be used for migraine headaches.||
8194|098|B|||
8194|099|H|HOW TO USE:  See also Warning section.||
8194|100|H|   Read the Medication Guide provided by your pharmacist before||
8194|101|H|you start taking this product and each time you get a refill. If||
8194|102|H|you have any questions, ask your doctor or pharmacist.||
8194|103|H|   Take this medication by mouth with or without food as directed||
8194|104|H|by your doctor, usually every 4 hours as needed. Do not take more||
8194|105|H|than 6 capsules in a 24-hour period. If you have nausea, you may||
8194|106|H|take this medication with food. Ask your doctor or pharmacist||
8194|107|H|about other ways to decrease nausea (such as lying down for 1-2||
8194|108|H|hours with as little head movement as possible).||
8194|109|H|   The dosage is based on your medical condition, age, and||
8194|110|H|response to treatment. This medication works best if it is used||
8194|111|H|as the first signs of a headache occur. If you wait until the||
8194|112|H|headache has worsened, the medication may not work as well.||
8194|113|H|   Do not increase your dose or use this drug more often or for||
8194|114|H|longer than prescribed, because your risk of side effects may||
8194|115|H|increase. Properly stop the medication when so directed.||
8194|116|H|   Suddenly stopping this medication may cause withdrawal,||
8194|117|H|especially if you have used it for a long time or in high doses.||
8194|118|H|To prevent withdrawal, your doctor may lower your dose slowly.||
8194|119|H|Tell your doctor or pharmacist right away if you have any||
8194|120|H|withdrawal symptoms such as restlessness, mental/mood changes||
8194|121|H|(including anxiety, trouble sleeping, thoughts of suicide),||
8194|122|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
8194|123|H|aches, or sudden changes in behavior.||
8194|124|H|   Though it helps many people, this medication may sometimes||
8194|125|H|cause addiction. This risk may be higher if you have a||
8194|126|H|mental/mood disorder or a substance use disorder (such as overuse||
8194|127|H|of or addiction to drugs/alcohol). Take this medication exactly||
8194|128|H|as prescribed to lower the risk of addiction. Ask your doctor or||
8194|129|H|pharmacist for more details.||
8194|130|H|   Tell your doctor if you notice increased use of this||
8194|131|H|medication, a worsening of headaches, an increase in the number||
8194|132|H|of headaches, the medication not working as well, use of this||
8194|133|H|medication for more than 2 headache episodes a week, or if you||
8194|134|H|have any new pain. Your doctor may need to change your medication||
8194|135|H|and/or add a separate medication to prevent the headaches.||
8194|136|B|||
8194|137|S|SIDE EFFECTS:  See also Warning section.||
8194|138|S|   Nausea, vomiting, abdominal pain, shaking (tremor), shortness||
8194|139|S|of breath, constipation, dry mouth, lightheadedness, dizziness,||
8194|140|S|drowsiness, or trouble sleeping may occur. If any of these||
8194|141|S|effects last or get worse, tell your doctor or pharmacist||
8194|142|S|promptly.||
8194|143|S|   To reduce the risk of dizziness and lightheadedness, get up||
8194|144|S|slowly when rising from a sitting or lying position.||
8194|145|S|   To prevent constipation, eat dietary fiber, drink enough||
8194|146|S|water, and exercise. You may also need to take a laxative. Ask||
8194|147|S|your pharmacist which type of laxative is right for you.||
8194|148|S|   Remember that this medication has been prescribed because your||
8194|149|S|doctor has judged that the benefit to you is greater than the||
8194|150|S|risk of side effects. Many people using this medication do not||
8194|151|S|have serious side effects.||
8194|152|S|   Tell your doctor right away if you have any serious side||
8194|153|S|effects, including: interrupted breathing during sleep (sleep||
8194|154|S|apnea), mental/mood changes, fast/irregular heartbeat, increased||
8194|155|S|thirst/urination, easy bruising/bleeding, difficulty urinating,||
8194|156|S|signs of your adrenal glands not working well (such as loss of||
8194|157|S|appetite, unusual tiredness, weight loss), trouble swallowing.||
8194|158|S|   Get medical help right away if you have any very serious side||
8194|159|S|effects, including: fainting, seizure.||
8194|160|S|   Codeine is changed into a strong opioid drug (morphine) in||
8194|161|S|your body. In some people, this change happens faster and more||
8194|162|S|completely than usual, which increases the risk of very serious||
8194|163|S|side effects. Get medical help right away if you notice any of||
8194|164|S|the following: slow/shallow breathing, severe||
8194|165|S|drowsiness/difficulty waking up, confusion.||
8194|166|S|   A very serious allergic reaction to this drug is rare.||
8194|167|S|However, get medical help right away if you notice any symptoms||
8194|168|S|of a serious allergic reaction, including: rash, itching/swelling||
8194|169|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8194|170|S|breathing.||
8194|171|S|   This is not a complete list of possible side effects. If you||
8194|172|S|notice other effects not listed above, contact your doctor or||
8194|173|S|pharmacist.||
8194|174|S|   In the US -||
8194|175|S|   Call your doctor for medical advice about side effects. You||
8194|176|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8194|177|S|www.fda.gov/medwatch.||
8194|178|S|   In Canada - Call your doctor for medical advice about side||
8194|179|S|effects. You may report side effects to Health Canada at||
8194|180|S|1-866-234-2345.||
8194|181|B|||
8194|182|P|PRECAUTIONS:  See also Warning section.||
8194|183|P|   Before taking this medication, tell your doctor or pharmacist||
8194|184|P|if you are allergic to acetaminophen, caffeine, codeine, or||
8194|185|P|butalbital; or to other barbiturates (such as phenobarbital),||
8194|186|P|xanthine derivatives (such as theophylline) or opioid pain||
8194|187|P|medications (such as morphine); or if you have any other||
8194|188|P|allergies. This product may contain inactive ingredients, which||
8194|189|P|can cause allergic reactions or other problems. Talk to your||
8194|190|P|pharmacist for more details.||
8194|191|P|   Before using this medication, tell your doctor or pharmacist||
8194|192|P|your medical history, especially of: a certain enzyme disorder||
8194|193|P|(porphyria), brain disorders (such as seizures, head injury,||
8194|194|P|tumor, increased intracranial pressure), breathing problems (such||
8194|195|P|as asthma, sleep apnea, chronic obstructive pulmonary||
8194|196|P|disease-COPD), disease of the pancreas (such as pancreatitis),||
8194|197|P|heart disease (such as irregular heartbeat, recent heart attack),||
8194|198|P|liver disease, kidney disease, a certain spinal problem||
8194|199|P|(kyphoscoliosis), gallbladder disease, personal or family history||
8194|200|P|of a substance use disorder (such as overuse of or addiction to||
8194|201|P|drugs/alcohol), mental/mood disorders, obesity,||
8194|202|P|stomach/intestinal problems (such as blockage, constipation,||
8194|203|P|diarrhea due to infection, paralytic ileus, stomach ulcer,||
8194|204|P|colitis), adrenal gland problem (such as Addison's disease),||
8194|205|P|difficulty urinating (such as due to enlarged prostate or||
8194|206|P|urethral stricture), underactive thyroid (hypothyroidism), recent||
8194|207|P|bowel/abdominal surgery.||
8194|208|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8194|209|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8194|210|P|machinery, or do anything that needs alertness until you can do||
8194|211|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
8194|212|P|are using marijuana (cannabis).||
8194|213|P|   Before having surgery or certain medical procedures (such as a||
8194|214|P|heart stress test or a procedure to restore a normal heart rhythm||
8194|215|P|if you have an unusually fast heartbeat), tell your doctor or||
8194|216|P|dentist that you use this medication and about all the products||
8194|217|P|you use (including prescription drugs, nonprescription drugs, and||
8194|218|P|herbal products).||
8194|219|P|   Older adults may be more sensitive to the side effects of this||
8194|220|P|drug, especially confusion, dizziness, drowsiness, slow/shallow||
8194|221|P|breathing, and trouble falling asleep. Confusion, dizziness,||
8194|222|P|drowsiness, and trouble falling asleep can increase the risk of||
8194|223|P|falling.||
8194|224|P|   During pregnancy, this medication should be used only when||
8194|225|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
8194|226|P|benefits with your doctor.||
8194|227|P|   This medication passes into breast milk and may have||
8194|228|P|undesirable effects on a nursing infant, such as unusual||
8194|229|P|sleepiness, difficulty feeding, trouble breathing, or unusual||
8194|230|P|limpness. Consult your doctor before breastfeeding.||
8194|231|B|||
8194|232|I|DRUG INTERACTIONS:  See also Warning section.||
8194|233|I|   Drug interactions may change how your medications work or||
8194|234|I|increase your risk for serious side effects. This document does||
8194|235|I|not contain all possible drug interactions. Keep a list of all||
8194|236|I|the products you use (including prescription/nonprescription||
8194|237|I|drugs and herbal products) and share it with your doctor and||
8194|238|I|pharmacist. Do not start, stop, or change the dosage of any||
8194|239|I|medicines without your doctor's approval.||
8194|240|I|   Some products that may interact with this drug include:||
8194|241|I|darunavir, isoniazid, lithium, methoxyflurane, naltrexone, other||
8194|242|I|medications for pain (such as morphine, nalbuphine, pentazocine),||
8194|243|I|phenothiazines (such as chlorpromazine), samidorphan, sodium||
8194|244|I|oxybate.||
8194|245|I|   This drug can speed up the removal of other drugs from your||
8194|246|I|body, which may affect how they work. Examples of affected drugs||
8194|247|I|include doxycycline, estrogen, felodipine, lonafarnib, quinidine,||
8194|248|I|rilpivirine, tamoxifen, theophylline, "blood thinners" (such as||
8194|249|I|warfarin), certain beta blockers (such as metoprolol),||
8194|250|I|corticosteroids (such as prednisone), among others.||
8194|251|I|   The risk of serious side effects (such as slow/shallow||
8194|252|I|breathing, severe drowsiness/dizziness) may be increased if this||
8194|253|I|medication is taken with other products that may also cause||
8194|254|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
8194|255|I|if you are taking other products such as other opioid pain or||
8194|256|I|cough relievers (such as morphine, hydrocodone), alcohol,||
8194|257|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
8194|258|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
8194|259|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
8194|260|I|cetirizine, diphenhydramine).||
8194|261|I|   Check the labels on all your medicines (such as allergy or||
8194|262|I|cough-and-cold products) because they may contain caffeine or||
8194|263|I|ingredients that cause drowsiness. Certain beverages (such as||
8194|264|I|coffee, colas, tea) may also contain caffeine. Ask your||
8194|265|I|pharmacist about using those products safely.||
8194|266|I|   Other medications can affect the removal of this product from||
8194|267|I|your body, which may affect how this product works. Examples||
8194|268|I|include azole antifungals (such as ketoconazole), bupropion,||
8194|269|I|fluoxetine, macrolide antibiotics (such as erythromycin),||
8194|270|I|levoketoconazole, paroxetine, quinidine, rifamycins (such as||
8194|271|I|rifabutin, rifampin), ritonavir, certain drugs used to treat||
8194|272|I|seizures (such as carbamazepine, phenytoin), among others.||
8194|273|I|   This medication may decrease the effectiveness of hormonal||
8194|274|I|birth control such as pills, patch, or ring. This could cause||
8194|275|I|pregnancy. Discuss with your doctor or pharmacist if you should||
8194|276|I|use reliable backup birth control methods while using this||
8194|277|I|medication. Also tell your doctor if you have any new spotting or||
8194|278|I|breakthrough bleeding, because these may be signs that your birth||
8194|279|I|control is not working well.||
8194|280|I|   This medication may interfere with certain medical/lab tests||
8194|281|I|(such as urine 5-HIAA levels, urine VMA levels, urine||
8194|282|I|catecholamine levels, amylase and lipase levels,||
8194|283|I|dipyridamole-thallium imaging tests), possibly causing false test||
8194|284|I|results. Make sure lab personnel and all your doctors know you||
8194|285|I|use this drug.||
8194|286|B|||
8194|287|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8194|288|O|as passing out or trouble breathing, give them naloxone or||
8194|289|O|nalmefene if available, then call 911. If the person is awake and||
8194|290|O|has no symptoms, call a poison control center right away. US||
8194|291|O|residents can call 1-800-222-1222. Canada residents can call||
8194|292|O|1-844-764-7669. Symptoms of overdose may include: severe||
8194|293|O|drowsiness/dizziness, slow/shallow breathing, very small pupils,||
8194|294|O|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
8194|295|O|pain, extreme tiredness, yellowing eyes/skin, dark urine, coma.||
8194|296|B|||
8194|297|N|NOTES:  Do not share this medication with others. Sharing it is||
8194|298|N|against the law.||
8194|299|N|   Massage, hot baths, and other relaxation methods can help with||
8194|300|N|tension headaches. Consult your doctor or pharmacist for more||
8194|301|N|details.||
8194|302|N|   Lab and/or medical tests (such as liver/kidney function) may||
8194|303|N|be done while you are taking this medication. Keep all medical||
8194|304|N|and lab appointments. Consult your doctor for more details.||
8194|305|B|||
8194|306|D|MISSED DOSE:  Not applicable.||
8194|307|B|||
8194|308|R|STORAGE:  Store at room temperature away from light and moisture.||
8194|309|R|Do not store in the bathroom. Keep all medications away from||
8194|310|R|children and pets.||
8194|311|R|   Do not flush medications down the toilet or pour them into a||
8194|312|R|drain unless instructed to do so. Properly discard this product||
8194|313|R|when it is expired or no longer needed. Consult your pharmacist||
8194|314|R|or local waste disposal company.||
8194|315|B|||
8194|316|A|Information last revised August 2025.||
8194|317|A|Copyright(c) 2025 First Databank, Inc.||
8194|318|B|||
8196|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8196|002|Z|does NOT have all possible information about this product. This||
8196|003|Z|information does not assure that this product is safe, effective,||
8196|004|Z|or appropriate for you. This information is not individual||
8196|005|Z|medical advice and does not substitute for the advice of your||
8196|006|Z|health care professional. Always ask your health care||
8196|007|Z|professional for complete information about this product and your||
8196|008|Z|specific health needs.||
8196|009|B|||
8196|010|T|NEOMYCIN/POLYMYXIN/HYDROCORTISONE SUSPENSION - OTIC||
8196|011|F|(nee-oh-MY-sin/paw-lee-MIX-in/hi-dro-KOR-tih-sown)||
8196|012|B|||
8196|013|C|COMMON BRAND NAME(S): Cortisporin, Pediotic||
8196|014|B|||
8196|015|U|USES:  This ear drop is used to treat outer ear infections caused||
8196|016|U|by bacteria (also known as swimmer's ear). This medication||
8196|017|U|contains neomycin and polymyxin, which are antibiotics that work||
8196|018|U|by stopping the growth of bacteria. It also contains||
8196|019|U|hydrocortisone, which is an anti-inflammatory corticosteroid that||
8196|020|U|works by reducing ear swelling and discomfort.||
8196|021|U|   This medication treats only bacterial ear infections. It will||
8196|022|U|not work for other types of ear infections. Unnecessary use or||
8196|023|U|overuse of any antibiotic can lead to its decreased||
8196|024|U|effectiveness.||
8196|025|B|||
8196|026|H|HOW TO USE:  Use this medication in the infected ear as directed||
8196|027|H|by your doctor, usually 3 or 4 times a day. The ear canal should||
8196|028|H|be clean and dry before using this medication. Use in the ear||
8196|029|H|only. Do not use in the eyes.||
8196|030|H|   To make sure that the right amount of medication is given, and||
8196|031|H|to avoid touching the ear with the dropper, have another person||
8196|032|H|give the drops if possible. To lower the risk of dizziness, hold||
8196|033|H|the container in your hand for a few minutes in order to warm it.||
8196|034|H|   To apply ear drops, wash your hands first. To avoid||
8196|035|H|contamination, do not touch the dropper tip or let it touch your||
8196|036|H|ear or any other surface. Shake the container well before using.||
8196|037|H|   Lie on your side with the treated ear upward. Hold the dropper||
8196|038|H|directly over the ear and place the prescribed number of drops||
8196|039|H|into the ear canal. To help the drops roll into the ear of an||
8196|040|H|adult, hold the earlobe up and back. For children, hold the||
8196|041|H|earlobe down and back. Keep the head tilted with the treated ear||
8196|042|H|upward for 5 minutes or insert a soft cotton plug if so directed.||
8196|043|H|Another way to give this medication is to place a cotton wick in||
8196|044|H|the ear canal and moisten it with the prescribed number of drops||
8196|045|H|as often as directed. The wick should be replaced at least once a||
8196|046|H|day.||
8196|047|H|   Repeat the above steps for the other ear if so directed. Do||
8196|048|H|not rinse the dropper. Replace the cap after use.||
8196|049|H|   Use this medication regularly in order to get the most benefit||
8196|050|H|from it. To help you remember, use it at the same times each day.||
8196|051|H|Continue to use this medication for the full time prescribed,||
8196|052|H|even if symptoms disappear after a few days. Stopping the||
8196|053|H|medication too early may result in a return of the infection.||
8196|054|H|   Do not use this medication more often than prescribed or||
8196|055|H|continue to use it for longer than 10 days.||
8196|056|H|   Tell your doctor if your condition lasts or gets worse.||
8196|057|B|||
8196|058|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
8196|059|S|ear for a minute or two when applied. If these effects last or||
8196|060|S|get worse, tell your doctor or pharmacist promptly.||
8196|061|S|   Remember that this medication has been prescribed because your||
8196|062|S|doctor has judged that the benefit to you is greater than the||
8196|063|S|risk of side effects. Many people using this medication do not||
8196|064|S|have serious side effects.||
8196|065|S|   Tell your doctor right away if you have any serious side||
8196|066|S|effects, including: hearing problems (such as hearing loss).||
8196|067|S|   Use of this medication for prolonged or repeated periods may||
8196|068|S|result in a new fungal ear infection. Do not use it for longer||
8196|069|S|than prescribed. Contact your doctor if you notice new or||
8196|070|S|worsening symptoms.||
8196|071|S|   A very serious allergic reaction to this drug is rare.||
8196|072|S|However, get medical help right away if you notice any symptoms||
8196|073|S|of a serious allergic reaction, including: rash, itching/swelling||
8196|074|S|(especially of the face/tongue/throat), redness of the ears,||
8196|075|S|severe dizziness, trouble breathing.||
8196|076|S|   This is not a complete list of possible side effects. If you||
8196|077|S|notice other effects not listed above, contact your doctor or||
8196|078|S|pharmacist.||
8196|079|S|   In the US -||
8196|080|S|   Call your doctor for medical advice about side effects. You||
8196|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8196|082|S|www.fda.gov/medwatch.||
8196|083|S|   In Canada - Call your doctor for medical advice about side||
8196|084|S|effects. You may report side effects to Health Canada at||
8196|085|S|1-866-234-2345.||
8196|086|B|||
8196|087|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
8196|088|P|pharmacist if you are allergic to neomycin, polymyxin, or||
8196|089|P|hydrocortisone; or to aminoglycoside antibiotics (such as||
8196|090|P|gentamicin, tobramycin), or to corticosteroids (such as||
8196|091|P|dexamethasone, prednisone); or if you have any other allergies.||
8196|092|P|This product may contain inactive ingredients (such as||
8196|093|P|preservatives like sulfites, thimerosal), which can cause||
8196|094|P|allergic reactions or other problems. Talk to your pharmacist for||
8196|095|P|more details.||
8196|096|P|   Before using this medication, tell your doctor or pharmacist||
8196|097|P|your medical history, especially of: other ear problems (such as||
8196|098|P|a hole in your eardrum, middle ear infection), an ear infection||
8196|099|P|caused by a virus (such as herpes simplex, varicella).||
8196|100|P|   This medication should be used only if clearly needed during||
8196|101|P|pregnancy. Discuss the risks and benefits with your doctor.||
8196|102|P|   It is unknown if this medication passes into breast milk.||
8196|103|P|Consult your doctor before breastfeeding.||
8196|104|B|||
8196|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8196|106|I|medications work or increase your risk for serious side effects.||
8196|107|I|This document does not contain all possible drug interactions.||
8196|108|I|Keep a list of all the products you use (including||
8196|109|I|prescription/nonprescription drugs and herbal products) and share||
8196|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
8196|111|I|the dosage of any medicines without your doctor's approval.||
8196|112|B|||
8196|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8196|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8196|115|O|poison control center right away. US residents can call||
8196|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669. This||
8196|117|O|medicine may be harmful if swallowed.||
8196|118|B|||
8196|119|N|NOTES:  Do not share this medication with others.||
8196|120|N|   This medication has been prescribed for your current condition||
8196|121|N|only. Do not use it later for another infection unless your||
8196|122|N|doctor tells you to.||
8196|123|N|   It is important to keep the infected ear(s) clean and dry. Try||
8196|124|N|not to get the infected ear(s) wet when bathing. Avoid swimming||
8196|125|N|unless your doctor tells you otherwise.||
8196|126|B|||
8196|127|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8196|128|D|If it is near the time of the next dose, skip the missed dose.||
8196|129|D|Use your next dose at the regular time. Do not double the dose to||
8196|130|D|catch up.||
8196|131|B|||
8196|132|R|STORAGE:  Store in the refrigerator or at room temperature away||
8196|133|R|from heat and light. Keep all medications away from children and||
8196|134|R|pets.||
8196|135|R|   Do not flush medications down the toilet or pour them into a||
8196|136|R|drain unless instructed to do so. Properly discard this product||
8196|137|R|when it is expired or no longer needed. Consult your pharmacist||
8196|138|R|or local waste disposal company.||
8196|139|B|||
8196|140|A|Information last revised May 2024.||
8196|141|A|Copyright(c) 2025 First Databank, Inc.||
8196|142|B|||
8198|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8198|002|Z|does NOT have all possible information about this product. This||
8198|003|Z|information does not assure that this product is safe, effective,||
8198|004|Z|or appropriate for you. This information is not individual||
8198|005|Z|medical advice and does not substitute for the advice of your||
8198|006|Z|health care professional. Always ask your health care||
8198|007|Z|professional for complete information about this product and your||
8198|008|Z|specific health needs.||
8198|009|B|||
8198|010|T|HYDROQUINONE/SUNSCREEN - TOPICAL||
8198|011|F|(hi-dro-KWIN-own/sunscreen)||
8198|012|B|||
8198|013|U|USES:  Hydroquinone is used to lighten the dark patches of skin||
8198|014|U|(also called hyperpigmentation, melasma, "liver spots," "age||
8198|015|U|spots," freckles) caused by pregnancy, birth control pills,||
8198|016|U|hormone medicine, or injury to the skin. This product also||
8198|017|U|contains sunscreens to help prevent spots from returning due to||
8198|018|U|sunlight or ultraviolet light exposure.||
8198|019|U|   This medicine works by blocking the process in the skin that||
8198|020|U|leads to discoloration.||
8198|021|B|||
8198|022|H|HOW TO USE:  Before using, apply a small amount of this medicine||
8198|023|H|to an area of unbroken skin, and check the area within 24 hours||
8198|024|H|for any serious side effects. If the test area is itching, red,||
8198|025|H|puffy, or blistering, do not use this product and contact your||
8198|026|H|doctor. If there is just mild redness, then treatment with this||
8198|027|H|product may begin.||
8198|028|H|   Apply this medication to the affected areas of skin, usually||
8198|029|H|twice daily or as directed by your doctor. This medication is for||
8198|030|H|use on the skin only. If it is used incorrectly, unwanted skin||
8198|031|H|lightening may occur. Avoid getting this product in your eyes or||
8198|032|H|on the inside of your nose or mouth. If you do get this||
8198|033|H|medication in those areas, flush with plenty of water.||
8198|034|H|   This medication may make the treated areas of skin more||
8198|035|H|sensitive to the sun. Avoid prolonged sun exposure, tanning||
8198|036|H|booths, and sunlamps, and wear protective clothing on the treated||
8198|037|H|areas of skin when outdoors. This product contains a sunscreen,||
8198|038|H|but it should not be used as a sunscreen for other skin that is||
8198|039|H|not being treated for discoloration. Instead, apply a separate||
8198|040|H|sunscreen of SPF 15 or greater to your normal skin.||
8198|041|H|   Use this medication regularly to get the most benefit from it.||
8198|042|H|To help you remember, use it at the same times each day.||
8198|043|H|   Tell your doctor if your condition lasts or gets worse after 2||
8198|044|H|months.||
8198|045|B|||
8198|046|S|SIDE EFFECTS:  See also How to Use.||
8198|047|S|   Mild burning, stinging, redness, and dryness may occur. If any||
8198|048|S|of these effects last or get worse, tell your doctor or||
8198|049|S|pharmacist promptly.||
8198|050|S|   If your doctor has directed you to use this medication,||
8198|051|S|remember that your doctor has judged that the benefit to you is||
8198|052|S|greater than the risk of side effects. Many people using this||
8198|053|S|medication do not have serious side effects.||
8198|054|S|   Stop using this product and tell your doctor right away if you||
8198|055|S|have any serious side effects, including: blistering, skin||
8198|056|S|cracking, blue-black darkening of the skin.||
8198|057|S|   A very serious allergic reaction to this drug is rare.||
8198|058|S|However, get medical help right away if you notice any symptoms||
8198|059|S|of a serious allergic reaction, including: rash, itching/swelling||
8198|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8198|061|S|breathing.||
8198|062|S|   This is not a complete list of possible side effects. If you||
8198|063|S|notice other effects not listed above, contact your doctor or||
8198|064|S|pharmacist.||
8198|065|S|   In the US -||
8198|066|S|   Call your doctor for medical advice about side effects. You||
8198|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8198|068|S|www.fda.gov/medwatch.||
8198|069|S|   In Canada - Call your doctor for medical advice about side||
8198|070|S|effects. You may report side effects to Health Canada at||
8198|071|S|1-866-234-2345.||
8198|072|B|||
8198|073|P|PRECAUTIONS:  Before using hydroquinone, tell your doctor or||
8198|074|P|pharmacist if you are allergic to it; or to sunscreens; or if you||
8198|075|P|have any other allergies. This product may contain inactive||
8198|076|P|ingredients (such as sulfites), which can cause allergic||
8198|077|P|reactions or other problems. Talk to your pharmacist for more||
8198|078|P|details.||
8198|079|P|   Before using this medication, tell your doctor or pharmacist||
8198|080|P|your medical history, especially of: asthma, other skin||
8198|081|P|conditions (such as eczema, psoriasis).||
8198|082|P|   Before having surgery, tell your doctor or dentist about all||
8198|083|P|the products you use (including prescription drugs,||
8198|084|P|nonprescription drugs, and herbal products).||
8198|085|P|   During pregnancy, this medication should be used only when||
8198|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
8198|087|P|   It is unknown if this drug passes into breast milk. Consult||
8198|088|P|your doctor before breastfeeding.||
8198|089|B|||
8198|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8198|091|I|medications work or increase your risk for serious side effects.||
8198|092|I|This document does not contain all possible drug interactions.||
8198|093|I|Keep a list of all the products you use (including||
8198|094|I|prescription/nonprescription drugs and herbal products) and share||
8198|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
8198|096|I|the dosage of any medicines without your doctor's approval.||
8198|097|B|||
8198|098|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8198|099|O|has overdosed and has serious symptoms such as passing out or||
8198|100|O|trouble breathing, call 911. Otherwise, call a poison control||
8198|101|O|center right away. US residents can call 1-800-222-1222. Canada||
8198|102|O|residents can call 1-844-764-7669. Symptoms after swallowing may||
8198|103|O|include: shaking (tremors), seizures.||
8198|104|B|||
8198|105|N|NOTES:  Do not share this medication with others.||
8198|106|N|   This medication has been prescribed for your current condition||
8198|107|N|only. Do not use it later for another skin problem unless told to||
8198|108|N|do so by your doctor. A different medication may be necessary in||
8198|109|N|that case.||
8198|110|B|||
8198|111|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8198|112|D|If it is near the time of the next dose, skip the missed dose.||
8198|113|D|Use your next dose at the regular time. Do not double the dose to||
8198|114|D|catch up.||
8198|115|B|||
8198|116|R|STORAGE:  Store at room temperature away from heat and light.||
8198|117|R|Keep all medications away from children and pets.||
8198|118|R|   Do not flush medications down the toilet or pour them into a||
8198|119|R|drain unless instructed to do so. Properly discard this product||
8198|120|R|when it is expired or no longer needed. Consult your pharmacist||
8198|121|R|or local waste disposal company.||
8198|122|B|||
8198|123|A|Information last revised May 2024.||
8198|124|A|Copyright(c) 2025 First Databank, Inc.||
8198|125|B|||
8206|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8206|002|Z|does NOT have all possible information about this product. This||
8206|003|Z|information does not assure that this product is safe, effective,||
8206|004|Z|or appropriate for you. This information is not individual||
8206|005|Z|medical advice and does not substitute for the advice of your||
8206|006|Z|health care professional. Always ask your health care||
8206|007|Z|professional for complete information about this product and your||
8206|008|Z|specific health needs.||
8206|009|B|||
8206|010|T|NYSTATIN SUSPENSION - ORAL||
8206|011|F|(NYE-stat-in)||
8206|012|B|||
8206|013|C|COMMON BRAND NAME(S): Mycostatin||
8206|014|B|||
8206|015|U|USES:  This medication is used to treat fungal infections of the||
8206|016|U|mouth. Nystatin is an antifungal that works by stopping the||
8206|017|U|growth of fungus.||
8206|018|U|   Nystatin suspension should not be used to treat fungal||
8206|019|U|infections of the blood.||
8206|020|B|||
8206|021|H|HOW TO USE:  Use this medication as directed by your doctor,||
8206|022|H|usually 4 times a day. Shake the bottle well before each dose.||
8206|023|H|Carefully measure the dose using a special measuring||
8206|024|H|device/spoon. Do not use a household spoon because you may not||
8206|025|H|get the correct dose.||
8206|026|H|   Unless your doctor instructs you otherwise, use as follows:||
8206|027|H|Place half of the dose in one side of the mouth. Swish it around||
8206|028|H|the mouth, gargle, and swallow or spit out as directed. Keep the||
8206|029|H|liquid in your mouth for as long as possible. Then repeat with||
8206|030|H|the remaining half of the dose in the other side of the mouth.||
8206|031|H|Avoid eating for 5 to 10 minutes after using this medication.||
8206|032|H|   It may take from several days to several months to complete||
8206|033|H|treatment. Use this medication regularly in order to get the most||
8206|034|H|benefit from it. Remember to use it at the same times each day.||
8206|035|H|The dosage is based on your medical condition and response to||
8206|036|H|treatment.||
8206|037|H|   Continue to use this medication until the full prescribed||
8206|038|H|amount is finished, even if symptoms disappear after a few days.||
8206|039|H|Stopping the medication too early may allow the infection to||
8206|040|H|continue, resulting in a return of the infection.||
8206|041|H|   Tell your doctor if your condition lasts after several days of||
8206|042|H|treatment or if it gets worse.||
8206|043|B|||
8206|044|S|SIDE EFFECTS:  Mouth irritation, diarrhea, nausea, vomiting, or||
8206|045|S|stomach upset may occur. If any of these effects last or get||
8206|046|S|worse, tell your doctor or pharmacist promptly.||
8206|047|S|   Remember that this medication has been prescribed because your||
8206|048|S|doctor has judged that the benefit to you is greater than the||
8206|049|S|risk of side effects. Many people using this medication do not||
8206|050|S|have serious side effects.||
8206|051|S|   Tell your doctor right away if you have any serious side||
8206|052|S|effects, including: fast heartbeat, wheezing, muscle pain.||
8206|053|S|   A very serious allergic reaction to this drug is rare.||
8206|054|S|However, get medical help right away if you notice any symptoms||
8206|055|S|of a serious allergic reaction, including: rash, itching/swelling||
8206|056|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8206|057|S|breathing.||
8206|058|S|   This is not a complete list of possible side effects. If you||
8206|059|S|notice other effects not listed above, contact your doctor or||
8206|060|S|pharmacist.||
8206|061|S|   In the US -||
8206|062|S|   Call your doctor for medical advice about side effects. You||
8206|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8206|064|S|www.fda.gov/medwatch.||
8206|065|S|   In Canada - Call your doctor for medical advice about side||
8206|066|S|effects. You may report side effects to Health Canada at||
8206|067|S|1-866-234-2345.||
8206|068|B|||
8206|069|P|PRECAUTIONS:  Before taking nystatin, tell your doctor or||
8206|070|P|pharmacist if you are allergic to it; or if you have any other||
8206|071|P|allergies. This product may contain inactive ingredients, which||
8206|072|P|can cause allergic reactions or other problems. Talk to your||
8206|073|P|pharmacist for more details.||
8206|074|P|   Before using this medication, tell your doctor or pharmacist||
8206|075|P|your medical history, especially of: HIV disease, diabetes,||
8206|076|P|kidney disease.||
8206|077|P|   This product contains sugar. Caution is advised if you have||
8206|078|P|diabetes. Ask your doctor or pharmacist about the safe use of||
8206|079|P|this product.||
8206|080|P|   Denture wearers need to be careful to properly clean and||
8206|081|P|maintain their dentures during treatment with this medication.||
8206|082|P|   Before having surgery, tell your doctor or dentist about all||
8206|083|P|the products you use (including prescription drugs,||
8206|084|P|nonprescription drugs, and herbal products).||
8206|085|P|   During pregnancy, this medication should be used only when||
8206|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
8206|087|P|   It is unknown if this drug passes into breast milk. Consult||
8206|088|P|your doctor before breastfeeding.||
8206|089|B|||
8206|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8206|091|I|medications work or increase your risk for serious side effects.||
8206|092|I|This document does not contain all possible drug interactions.||
8206|093|I|Keep a list of all the products you use (including||
8206|094|I|prescription/nonprescription drugs and herbal products) and share||
8206|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
8206|096|I|the dosage of any medicines without your doctor's approval.||
8206|097|B|||
8206|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8206|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8206|100|O|poison control center right away. US residents can call||
8206|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8206|102|B|||
8206|103|N|NOTES:  Do not share this medication with others.||
8206|104|N|   This medication has been prescribed for your current condition||
8206|105|N|only. Do not use it later for another infection unless your||
8206|106|N|doctor tells you to.||
8206|107|B|||
8206|108|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8206|109|D|If it is near the time of the next dose, skip the missed dose.||
8206|110|D|Use your next dose at the regular time. Do not double the dose to||
8206|111|D|catch up.||
8206|112|B|||
8206|113|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
8206|114|R|medications away from children and pets.||
8206|115|R|   Do not flush medications down the toilet or pour them into a||
8206|116|R|drain unless instructed to do so. Properly discard this product||
8206|117|R|when it is expired or no longer needed. Consult your pharmacist||
8206|118|R|or local waste disposal company.||
8206|119|B|||
8206|120|A|Information last revised October 2024.||
8206|121|A|Copyright(c) 2025 First Databank, Inc.||
8206|122|B|||
8211|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8211|002|Z|does NOT have all possible information about this product. This||
8211|003|Z|information does not assure that this product is safe, effective,||
8211|004|Z|or appropriate for you. This information is not individual||
8211|005|Z|medical advice and does not substitute for the advice of your||
8211|006|Z|health care professional. Always ask your health care||
8211|007|Z|professional for complete information about this product and your||
8211|008|Z|specific health needs.||
8211|009|B|||
8211|010|T|PEGFILGRASTIM - INJECTION||
8211|011|F|(PEG-fil-GRA-stim)||
8211|012|B|||
8211|013|C|COMMON BRAND NAME(S): Fulphila, Fylnetra, Neulasta, Nyvepria,||
8211|014|C|Stimufend, Udenyca, Ziextenzo||
8211|015|B|||
8211|016|U|USES:  Pegfilgrastim is a man-made version of a certain natural||
8211|017|U|substance made by your body. It is used to help your body make||
8211|018|U|more white blood cells. White blood cells are important to help||
8211|019|U|you fight off infections. Pegfilgrastim is given to people whose||
8211|020|U|ability to make white blood cells is reduced due to chemotherapy.||
8211|021|U|Some brands may also be used to increase white blood cells after||
8211|022|U|exposure to large amounts of radiation.||
8211|023|U|   This monograph is about the following pegfilgrastim products:||
8211|024|U|pegfilgrastim, pegfilgrastim-apgf, pegfilgrastim-bmez,||
8211|025|U|pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, and||
8211|026|U|pegfilgrastim-pbbk.||
8211|027|B|||
8211|028|H|HOW TO USE:  Read the Patient Information Leaflet and||
8211|029|H|Instructions for Use if available from your pharmacist before you||
8211|030|H|start using pegfilgrastim and each time you get a refill. If you||
8211|031|H|have any questions, ask your doctor or pharmacist.||
8211|032|H|   This medication is given by injection under the skin as||
8211|033|H|directed by your doctor. For use during chemotherapy, it is||
8211|034|H|usually given once during each chemotherapy cycle. However, it||
8211|035|H|should not be given within 14 days before or 24 hours after||
8211|036|H|chemotherapy. Ask your doctor for specific directions about when||
8211|037|H|to use this medication. For use after radiation exposure,||
8211|038|H|pegfilgrastim is usually given for 2 doses, one week apart.||
8211|039|H|   The dosage and schedule are based on your medical condition||
8211|040|H|and response to treatment. Children's dosage is also based on||
8211|041|H|weight.||
8211|042|H|   If you are using this medication at home, learn all||
8211|043|H|preparation and usage instructions from your health care||
8211|044|H|professional and the product package. Take the medication out of||
8211|045|H|the refrigerator at least 30 minutes before you inject it to||
8211|046|H|allow it to reach room temperature. Do not warm up this||
8211|047|H|medication any other way (for example, do not heat in the||
8211|048|H|microwave or place it in hot water). Do not shake this||
8211|049|H|medication. Before using, check this product for particles or||
8211|050|H|discoloration. If either is present, do not use the liquid.||
8211|051|H|Before injecting each dose, clean the skin you are going to||
8211|052|H|inject into (the injection site) with rubbing alcohol. Change the||
8211|053|H|injection site each time to lessen injury under the skin. Do not||
8211|054|H|inject into skin that is bruised, tender, red, hard, or that has||
8211|055|H|scars, moles, or stretch marks. To lessen bruising, do not rub||
8211|056|H|the injection site after a shot. Learn how to store and discard||
8211|057|H|medical supplies safely.||
8211|058|B|||
8211|059|S|SIDE EFFECTS:  Aching or pain in the bones and muscles may occur.||
8211|060|S|Taking a non-aspirin pain reliever such as acetaminophen may help||
8211|061|S|relieve pain. Ask your doctor or pharmacist for more details.||
8211|062|S|Redness, swelling, itching, or bruising at the injection site may||
8211|063|S|also occur. If any of these effects last or get worse, tell your||
8211|064|S|doctor or pharmacist promptly.||
8211|065|S|   Remember that this medication has been prescribed because your||
8211|066|S|doctor has judged that the benefit to you is greater than the||
8211|067|S|risk of side effects. Many people using this medication do not||
8211|068|S|have serious side effects.||
8211|069|S|   Tell your doctor right away if you have any serious side||
8211|070|S|effects, including: pink/bloody urine, easy bleeding/bruising,||
8211|071|S|fever, fast heartbeat, purple/red spots on your skin, back pain.||
8211|072|S|   Get medical help right away if you have any very serious side||
8211|073|S|effects, including: breathing problems (such as shortness of||
8211|074|S|breath, fast breathing), unusual decrease in urination, unusual||
8211|075|S|tiredness, swelling/puffiness of the body.||
8211|076|S|   Rarely, serious (possibly fatal) damage to the spleen may||
8211|077|S|occur. Get medical help right away if you develop||
8211|078|S|stomach/abdominal pain or shoulder pain.||
8211|079|S|   Rarely, this medication may increase the risk of developing a||
8211|080|S|certain bone marrow disorder (myelodysplastic syndrome-MDS) or||
8211|081|S|blood cancer (acute myeloid leukemia-AML) in people with breast||
8211|082|S|or lung cancer who are receiving chemotherapy/radiation. Ask your||
8211|083|S|doctor for more details.||
8211|084|S|   A very serious allergic reaction to this drug is rare.||
8211|085|S|However, get medical help right away if you notice any symptoms||
8211|086|S|of a serious allergic reaction, including: rash, itching/swelling||
8211|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8211|088|S|breathing.||
8211|089|S|   This is not a complete list of possible side effects. If you||
8211|090|S|notice other effects not listed above, contact your doctor or||
8211|091|S|pharmacist.||
8211|092|S|   In the US -||
8211|093|S|   Call your doctor for medical advice about side effects. You||
8211|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8211|095|S|www.fda.gov/medwatch.||
8211|096|S|   In Canada - Call your doctor for medical advice about side||
8211|097|S|effects. You may report side effects to Health Canada at||
8211|098|S|1-866-234-2345.||
8211|099|B|||
8211|100|P|PRECAUTIONS:  Before using pegfilgrastim, tell your doctor or||
8211|101|P|pharmacist if you are allergic to it; or to any pegfilgrastim or||
8211|102|P|filgrastim products; or to eflapegrastim; or if you have any||
8211|103|P|other allergies. This product may contain inactive ingredients||
8211|104|P|(such as dry natural rubber/latex in the needle cover on the||
8211|105|P|prefilled syringe), which can cause allergic reactions or other||
8211|106|P|problems. Talk to your pharmacist for more details.||
8211|107|P|   Before using this medication, tell your doctor or pharmacist||
8211|108|P|your medical history, especially of: sickle cell disease, spleen||
8211|109|P|problems.||
8211|110|P|   Before having surgery, tell your doctor or dentist about all||
8211|111|P|the products you use (including prescription drugs,||
8211|112|P|nonprescription drugs, and herbal products).||
8211|113|P|   During pregnancy, this medication should be used only when||
8211|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
8211|115|P|   This medication may pass into breast milk. Consult your doctor||
8211|116|P|before breastfeeding.||
8211|117|B|||
8211|118|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8211|119|I|medications work or increase your risk for serious side effects.||
8211|120|I|This document does not contain all possible drug interactions.||
8211|121|I|Keep a list of all the products you use (including||
8211|122|I|prescription/nonprescription drugs and herbal products) and share||
8211|123|I|it with your doctor and pharmacist. Do not start, stop, or change||
8211|124|I|the dosage of any medicines without your doctor's approval.||
8211|125|I|   Pegfilgrastim is very similar to filgrastim. Do not use a||
8211|126|I|filgrastim product while using a pegfilgrastim product.||
8211|127|I|   This medication may interfere with certain lab tests (such as||
8211|128|I|bone imaging tests), possibly causing false test results. Make||
8211|129|I|sure lab personnel and all your doctors know you use this drug.||
8211|130|B|||
8211|131|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8211|132|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8211|133|O|poison control center right away. US residents can call||
8211|134|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8211|135|B|||
8211|136|N|NOTES:  Do not share this medication with others.||
8211|137|N|   Lab and/or medical tests (such as complete blood count, kidney||
8211|138|N|function) should be done while you are using this medication.||
8211|139|N|Keep all medical and lab appointments. Consult your doctor for||
8211|140|N|more details.||
8211|141|B|||
8211|142|D|MISSED DOSE:  It is important to get each dose of this medication||
8211|143|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8211|144|D|right away for a new dosing schedule. Do not double the dose to||
8211|145|D|catch up.||
8211|146|B|||
8211|147|R|STORAGE:  Store in the refrigerator. Do not freeze or shake. Keep||
8211|148|R|the medication in the original package to protect from light. If||
8211|149|R|the medication is taken out of the refrigerator, use or discard||
8211|150|R|it within the time directed in your product package. Keep all||
8211|151|R|medications away from children and pets.||
8211|152|R|   Do not flush medications down the toilet or pour them into a||
8211|153|R|drain unless instructed to do so. Properly discard this product||
8211|154|R|when it is expired or no longer needed. Consult your pharmacist||
8211|155|R|or local waste disposal company.||
8211|156|B|||
8211|157|A|Information last revised August 2024.||
8211|158|A|Copyright(c) 2025 First Databank, Inc.||
8211|159|B|||
8216|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8216|002|Z|does NOT have all possible information about this product. This||
8216|003|Z|information does not assure that this product is safe, effective,||
8216|004|Z|or appropriate for you. This information is not individual||
8216|005|Z|medical advice and does not substitute for the advice of your||
8216|006|Z|health care professional. Always ask your health care||
8216|007|Z|professional for complete information about this product and your||
8216|008|Z|specific health needs.||
8216|009|B|||
8216|010|T|GLATIRAMER - INJECTION||
8216|011|F|(glah-TEE-ruh-mer)||
8216|012|B|||
8216|013|C|COMMON BRAND NAME(S): Copaxone||
8216|014|B|||
8216|015|W|WARNING:  This medication may cause serious (sometimes fatal)||
8216|016|W|allergic reactions. These reactions have occurred after the first||
8216|017|W|dose, later doses, or even years after starting treatment. Stop||
8216|018|W|using this medication and get medical help right away if you have||
8216|019|W|any symptoms of a serious allergic reaction such as trouble||
8216|020|W|breathing, seizures, severe dizziness, rash, or itching/swelling||
8216|021|W|(especially of the face/tongue/throat).||
8216|022|W|   These allergic reactions may be similar to post-injection||
8216|023|W|reactions that may occur within the first hour after injecting||
8216|024|W|this medication (see also Side Effect section). Talk to your||
8216|025|W|doctor about the differences between a post-injection reaction||
8216|026|W|and a serious allergic reaction.||
8216|027|B|||
8216|028|U|USES:  This medication is used to treat multiple sclerosis (MS).||
8216|029|U|It is a protein that is thought to work by preventing your immune||
8216|030|U|system from attacking the nerves in your brain and spinal cord.||
8216|031|U|This effect can decrease the number of periods of disease||
8216|032|U|worsening (relapses) and prevent or delay disability. It is not a||
8216|033|U|cure for MS.||
8216|034|B|||
8216|035|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
8216|036|H|provided by your pharmacist before you start using this||
8216|037|H|medication and each time you get a refill. Ask your health care||
8216|038|H|professional how to prepare and use this medication. If you have||
8216|039|H|any questions, ask your doctor or pharmacist.||
8216|040|H|   Inject this medication under the skin as directed by your||
8216|041|H|doctor, usually once daily or 3 times a week (at least 48 hours||
8216|042|H|apart). The injection is given in the hip, thigh, abdomen, or||
8216|043|H|back of the upper arm. The dosage is based on your medical||
8216|044|H|condition and response to treatment.||
8216|045|H|   Take the medication out of the refrigerator 20 minutes before||
8216|046|H|you inject it to allow it to reach room temperature. Do not||
8216|047|H|inject cold glatiramer because this can be painful. Before using,||
8216|048|H|check this product for particles or discoloration. If either is||
8216|049|H|present, do not use the liquid. Before injecting each dose, clean||
8216|050|H|the skin you are going to inject into (the injection site) with||
8216|051|H|rubbing alcohol. Change the injection site each time to lessen||
8216|052|H|injury under the skin. Keep track of your injections and do not||
8216|053|H|reuse the same injection site for at least 1 week. To lessen||
8216|054|H|bruising, do not rub the injection site after a shot. Learn how||
8216|055|H|to store and discard medical supplies safely.||
8216|056|H|   Use this medication regularly to get the most benefit from it.||
8216|057|H|Do not change your dose or stop using this medication without||
8216|058|H|talking with your doctor.||
8216|059|H|   Tell your doctor if your condition gets worse.||
8216|060|B|||
8216|061|S|SIDE EFFECTS:  See also Warning section.||
8216|062|S|   Injection site reactions (such as pain, redness, soreness, and||
8216|063|S|swelling) may occur. Nausea, chills, joint aches, neck pain, and||
8216|064|S|headache may also occur. If any of these effects last or get||
8216|065|S|worse, tell your doctor or pharmacist promptly.||
8216|066|S|   Immediately after injection, you may experience flushing,||
8216|067|S|chest pain, fast heartbeat, or anxiety. This post-injection||
8216|068|S|reaction usually starts to occur after you have used the drug for||
8216|069|S|a few months but can occur after any injection. These symptoms||
8216|070|S|disappear fairly quickly and usually do not require treatment. If||
8216|071|S|these symptoms do not go away in a few minutes, get medical help||
8216|072|S|right away. Tell your doctor right away about this reaction||
8216|073|S|before your next injection. Ask your doctor if you should keep||
8216|074|S|using this medication.||
8216|075|S|   Remember that this medication has been prescribed because your||
8216|076|S|doctor has judged that the benefit to you is greater than the||
8216|077|S|risk of side effects. Many people using this medication do not||
8216|078|S|have serious side effects.||
8216|079|S|   Tell your doctor right away if you have any serious side||
8216|080|S|effects, including: chest pain, signs of liver disease (such as||
8216|081|S|nausea/vomiting that doesn't stop, loss of appetite,||
8216|082|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
8216|083|S|of infection (such as sore throat that doesn't go away, fever,||
8216|084|S|chills), mental/mood changes (such as depression), severe pain at||
8216|085|S|the injection site, shakiness (tremor), swelling of the legs/feet||
8216|086|S|(water retention), vision problems.||
8216|087|S|   This is not a complete list of possible side effects. If you||
8216|088|S|notice other effects not listed above, contact your doctor or||
8216|089|S|pharmacist.||
8216|090|S|   In the US -||
8216|091|S|   Call your doctor for medical advice about side effects. You||
8216|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8216|093|S|www.fda.gov/medwatch.||
8216|094|S|   In Canada - Call your doctor for medical advice about side||
8216|095|S|effects. You may report side effects to Health Canada at||
8216|096|S|1-866-234-2345.||
8216|097|B|||
8216|098|P|PRECAUTIONS:  Before using glatiramer, tell your doctor or||
8216|099|P|pharmacist if you are allergic to it; or if you have any other||
8216|100|P|allergies. This product may contain inactive ingredients (such as||
8216|101|P|mannitol), which can cause allergic reactions or other problems.||
8216|102|P|Talk to your pharmacist for more details.||
8216|103|P|   Before using this medication, tell your doctor or pharmacist||
8216|104|P|your medical history, especially of: heart disease (such as chest||
8216|105|P|pain, heart attack), liver disease.||
8216|106|P|   Before having surgery, tell your doctor or dentist about all||
8216|107|P|the products you use (including prescription drugs,||
8216|108|P|nonprescription drugs, and herbal products).||
8216|109|P|   During pregnancy, this medication should be used only when||
8216|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
8216|111|P|   It is unknown if this medication passes into breast milk.||
8216|112|P|Consult your doctor before breastfeeding.||
8216|113|B|||
8216|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8216|115|I|medications work or increase your risk for serious side effects.||
8216|116|I|This document does not contain all possible drug interactions.||
8216|117|I|Keep a list of all the products you use (including||
8216|118|I|prescription/nonprescription drugs and herbal products) and share||
8216|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
8216|120|I|the dosage of any medicines without your doctor's approval.||
8216|121|B|||
8216|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8216|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8216|124|O|poison control center right away. US residents can call||
8216|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8216|126|B|||
8216|127|N|NOTES:  Do not share this medication, needles, or syringes with||
8216|128|N|others.||
8216|129|B|||
8216|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8216|131|D|If it is near the time of the next dose, skip the missed dose.||
8216|132|D|Use your next dose at the regular time. Do not double the dose to||
8216|133|D|catch up.||
8216|134|B|||
8216|135|R|STORAGE:  Store in the refrigerator. Do not freeze. Do not use||
8216|136|R|this medication if it has been frozen. Keep the medication in the||
8216|137|R|original carton to protect from light. This medication may also||
8216|138|R|be stored at room temperature if needed. If the medication is||
8216|139|R|stored at room temperature, discard after 1 month. Keep all||
8216|140|R|medications away from children and pets.||
8216|141|R|   Do not flush medications down the toilet or pour them into a||
8216|142|R|drain unless instructed to do so. Properly discard this product||
8216|143|R|when it is expired or no longer needed. Consult your pharmacist||
8216|144|R|or local waste disposal company.||
8216|145|B|||
8216|146|A|Information last revised May 2025.||
8216|147|A|Copyright(c) 2025 First Databank, Inc.||
8216|148|B|||
8217|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8217|002|Z|does NOT have all possible information about this product. This||
8217|003|Z|information does not assure that this product is safe, effective,||
8217|004|Z|or appropriate for you. This information is not individual||
8217|005|Z|medical advice and does not substitute for the advice of your||
8217|006|Z|health care professional. Always ask your health care||
8217|007|Z|professional for complete information about this product and your||
8217|008|Z|specific health needs.||
8217|009|B|||
8217|010|T|GABAPENTIN - ORAL||
8217|011|F|(gab-uh-PEN-tin)||
8217|012|B|||
8217|013|C|COMMON BRAND NAME(S): Neurontin||
8217|014|B|||
8217|015|U|USES:  Gabapentin is used with other medications to prevent and||
8217|016|U|control seizures. It is also used to relieve nerve pain following||
8217|017|U|shingles (a painful rash due to herpes zoster infection) in||
8217|018|U|adults. Gabapentin is known as an anticonvulsant or antiepileptic||
8217|019|U|drug.||
8217|020|B|||
8217|021|V|OTHER USES:  This section contains uses of this drug that are not||
8217|022|V|listed in the approved professional labeling for the drug but||
8217|023|V|that may be prescribed by your health care professional. Use this||
8217|024|V|drug for a condition that is listed in this section only if it||
8217|025|V|has been so prescribed by your health care professional.||
8217|026|V|   This drug may also be used for restless legs syndrome or other||
8217|027|V|nerve pain conditions (such as diabetic neuropathy, peripheral||
8217|028|V|neuropathy, trigeminal neuralgia).||
8217|029|B|||
8217|030|H|HOW TO USE:  Read the Medication Guide and, if available, the||
8217|031|H|Patient Information Leaflet provided by your pharmacist before||
8217|032|H|you start taking gabapentin and each time you get a refill. If||
8217|033|H|you have any questions, ask your doctor or pharmacist.||
8217|034|H|   Take this medication by mouth with or without food as directed||
8217|035|H|by your doctor. The dosage is based on your medical condition and||
8217|036|H|response to treatment. Children's dosage is also based on weight.||
8217|037|H|   If you are taking the tablets and your doctor directs you to||
8217|038|H|split the tablet in half, take the other half-tablet at your next||
8217|039|H|scheduled dose. Discard half tablets if not used within several||
8217|040|H|days of splitting them. If you are taking the capsules, swallow||
8217|041|H|them whole with plenty of water.||
8217|042|H|   It is very important to follow your doctor's dosing||
8217|043|H|instructions exactly. During the first few days of treatment,||
8217|044|H|your doctor may gradually increase your dose so your body can||
8217|045|H|adjust to the medication. To minimize side effects, take the very||
8217|046|H|first dose at bedtime.||
8217|047|H|   Take this medication regularly to get the most benefit from||
8217|048|H|it. This drug works best when the amount of medicine in your body||
8217|049|H|is kept at a constant level. Take gabapentin at evenly spaced||
8217|050|H|intervals at the same time(s) each day. If you are taking this||
8217|051|H|medication 3 times a day to control seizures, do not let more||
8217|052|H|than 12 hours pass between doses because your seizures may||
8217|053|H|increase.||
8217|054|H|   Do not take this medication more often or increase your dose||
8217|055|H|without consulting your doctor. Your condition will not improve||
8217|056|H|any faster and the risk of serious side effects may increase.||
8217|057|H|   Do not stop taking this medication without consulting your||
8217|058|H|doctor. Some conditions may become worse when this drug is||
8217|059|H|suddenly stopped. Also, you may experience symptoms such as||
8217|060|H|difficulty sleeping, sweating, nausea, and headache. To prevent||
8217|061|H|these symptoms while you are stopping treatment with this drug,||
8217|062|H|your doctor may reduce your dose gradually. Report any new or||
8217|063|H|worsening symptoms right away.||
8217|064|H|   Antacids containing aluminum or magnesium may interfere with||
8217|065|H|the absorption of this medication. If you are also taking an||
8217|066|H|antacid, it is best to take gabapentin at least 2 hours after||
8217|067|H|taking the antacid.||
8217|068|H|   Different forms of gabapentin (such as immediate-release,||
8217|069|H|sustained-release, enacarbil sustained-release) are absorbed in||
8217|070|H|the body differently. Do not switch from one form to the other||
8217|071|H|without consulting your doctor.||
8217|072|H|   Tell your doctor if your condition does not get better or if||
8217|073|H|it gets worse.||
8217|074|B|||
8217|075|S|SIDE EFFECTS:  Drowsiness, dizziness, loss of coordination,||
8217|076|S|tiredness, blurred/double vision, unusual eye movements, or||
8217|077|S|shaking (tremor) may occur. If any of these effects last or get||
8217|078|S|worse, tell your doctor or pharmacist promptly.||
8217|079|S|   Remember that this medication has been prescribed because your||
8217|080|S|doctor has judged that the benefit to you is greater than the||
8217|081|S|risk of side effects. Many people using this medication do not||
8217|082|S|have serious side effects.||
8217|083|S|   Tell your doctor right away if you have any serious side||
8217|084|S|effects, including: swelling of the hands/ankles/feet.||
8217|085|S|   A small number of people who take anticonvulsants for any||
8217|086|S|condition (such as seizures, bipolar disorder, pain) may||
8217|087|S|experience depression, suicidal thoughts/attempts, or other||
8217|088|S|mental/mood problems. These effects may occur even after the||
8217|089|S|medication has been stopped. Tell your doctor right away if you||
8217|090|S|or your family/caregiver notice any unusual/sudden changes in||
8217|091|S|your mood, thoughts, or behavior including signs of depression,||
8217|092|S|suicidal thoughts/attempts, thoughts about harming yourself.||
8217|093|S|   Get medical help right away if you have any very serious side||
8217|094|S|effects, including: slow/shallow breathing.||
8217|095|S|   A very serious allergic reaction to this drug is rare.||
8217|096|S|However, get medical help right away if you notice any symptoms||
8217|097|S|of a serious allergic reaction, including: fever, swollen lymph||
8217|098|S|nodes, rash, itching/swelling (especially of the||
8217|099|S|face/tongue/throat), severe dizziness, trouble breathing.||
8217|100|S|   This is not a complete list of possible side effects. If you||
8217|101|S|notice other effects not listed above, contact your doctor or||
8217|102|S|pharmacist.||
8217|103|S|   In the US -||
8217|104|S|   Call your doctor for medical advice about side effects. You||
8217|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8217|106|S|www.fda.gov/medwatch.||
8217|107|S|   In Canada - Call your doctor for medical advice about side||
8217|108|S|effects. You may report side effects to Health Canada at||
8217|109|S|1-866-234-2345.||
8217|110|B|||
8217|111|P|PRECAUTIONS:  Before taking gabapentin, tell your doctor or||
8217|112|P|pharmacist if you are allergic to it; or to gabapentin enacarbil;||
8217|113|P|or if you have any other allergies. This product may contain||
8217|114|P|inactive ingredients, which can cause allergic reactions or other||
8217|115|P|problems. Talk to your pharmacist for more details.||
8217|116|P|   Before using this medication, tell your doctor or pharmacist||
8217|117|P|your medical history, especially of: kidney disease, mental/mood||
8217|118|P|problems (such as depression, thoughts of suicide), use/abuse of||
8217|119|P|drugs/alcohol, breathing problems (such as COPD).||
8217|120|P|   This drug may make you dizzy or drowsy or blur your vision.||
8217|121|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8217|122|P|drowsy. Do not drive, use machinery, or do anything that needs||
8217|123|P|alertness or clear vision until you can do it safely. Limit||
8217|124|P|alcoholic beverages. Talk to your doctor if you are using||
8217|125|P|marijuana (cannabis).||
8217|126|P|   Before having surgery, tell your doctor or dentist about all||
8217|127|P|the products you use (including prescription drugs,||
8217|128|P|nonprescription drugs, and herbal products).||
8217|129|P|   Older adults may be more sensitive to the side effects of this||
8217|130|P|drug, especially swelling of the hands/ankles/feet, slow/shallow||
8217|131|P|breathing, dizziness, or loss of coordination. Dizziness and loss||
8217|132|P|of coordination can increase the risk of falling.||
8217|133|P|   Children may be more sensitive to the side effects of this||
8217|134|P|drug, especially mental/mood/behavior changes (such as hostility,||
8217|135|P|problems concentrating, restlessness).||
8217|136|P|   During pregnancy, this medication should be used only when||
8217|137|P|clearly needed. Discuss the risks and benefits with your doctor.||
8217|138|P|   Gabapentin passes into breast milk. Consult your doctor before||
8217|139|P|breastfeeding.||
8217|140|B|||
8217|141|I|DRUG INTERACTIONS:  See also How to Use section.||
8217|142|I|   Drug interactions may change how your medications work or||
8217|143|I|increase your risk for serious side effects. This document does||
8217|144|I|not contain all possible drug interactions. Keep a list of all||
8217|145|I|the products you use (including prescription/nonprescription||
8217|146|I|drugs and herbal products) and share it with your doctor and||
8217|147|I|pharmacist. Do not start, stop, or change the dosage of any||
8217|148|I|medicines without your doctor's approval.||
8217|149|I|   A product that may interact with this drug is: orlistat.||
8217|150|I|   The risk of serious side effects (such as slow/shallow||
8217|151|I|breathing, severe drowsiness/dizziness) may be increased if this||
8217|152|I|medication is taken with other products that may also cause||
8217|153|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
8217|154|I|if you are using other products such as opioid pain or cough||
8217|155|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8217|156|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
8217|157|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
8217|158|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8217|159|I|diphenhydramine).||
8217|160|I|   Check the labels on all your medicines (such as allergy or||
8217|161|I|cough-and-cold products) because they may contain ingredients||
8217|162|I|that cause drowsiness. Ask your pharmacist about using those||
8217|163|I|products safely.||
8217|164|I|   Do not use this medication with other medications that contain||
8217|165|I|gabapentin (including gabapentin enacarbil).||
8217|166|I|   This medication may interfere with certain lab tests (such as||
8217|167|I|urine protein), possibly causing false test results. Make sure||
8217|168|I|lab personnel and all your doctors know you use this drug.||
8217|169|B|||
8217|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8217|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8217|172|O|poison control center right away. US residents can call||
8217|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8217|174|O|Symptoms of overdose may include: severe drowsiness, trouble||
8217|175|O|speaking, weakness.||
8217|176|B|||
8217|177|N|NOTES:  Do not share this medication with others.||
8217|178|B|||
8217|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8217|180|D|remember. If it is near the time of the next dose, skip the||
8217|181|D|missed dose. Take your next dose at the regular time. Do not||
8217|182|D|double the dose to catch up. If you take gabapentin 3 times a day||
8217|183|D|to control seizures, do not let more than 12 hours pass between||
8217|184|D|doses because your seizures may increase. Consult your doctor||
8217|185|D|right away if this occurs.||
8217|186|B|||
8217|187|R|STORAGE:  Store at room temperature away from light and moisture.||
8217|188|R|Do not store in the bathroom. Keep all medications away from||
8217|189|R|children and pets.||
8217|190|R|   Do not flush medications down the toilet or pour them into a||
8217|191|R|drain unless instructed to do so. Properly discard this product||
8217|192|R|when it is expired or no longer needed. Consult your pharmacist||
8217|193|R|or local waste disposal company.||
8217|194|B|||
8217|195|M|MEDICAL ALERT:  Your condition can cause complications in a||
8217|196|M|medical emergency. For information about enrolling in MedicAlert,||
8217|197|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8217|198|B|||
8217|199|A|Information last revised May 2025.||
8217|200|A|Copyright(c) 2025 First Databank, Inc.||
8217|201|B|||
8218|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8218|002|Z|does NOT have all possible information about this product. This||
8218|003|Z|information does not assure that this product is safe, effective,||
8218|004|Z|or appropriate for you. This information is not individual||
8218|005|Z|medical advice and does not substitute for the advice of your||
8218|006|Z|health care professional. Always ask your health care||
8218|007|Z|professional for complete information about this product and your||
8218|008|Z|specific health needs.||
8218|009|B|||
8218|010|T|RIVASTIGMINE - ORAL||
8218|011|F|(riv-uh-STIG-meen)||
8218|012|B|||
8218|013|C|COMMON BRAND NAME(S): Exelon||
8218|014|B|||
8218|015|U|USES:  Rivastigmine is used to treat confusion (dementia) related||
8218|016|U|to Alzheimer's disease and to Parkinson's disease. Rivastigmine||
8218|017|U|does not cure either of these diseases, but it may improve||
8218|018|U|memory, awareness, and the ability to perform daily functions.||
8218|019|U|This medication works by restoring the balance of natural||
8218|020|U|substances (neurotransmitters) in the brain.||
8218|021|B|||
8218|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8218|023|H|from your pharmacist before you start taking rivastigmine and||
8218|024|H|each time you get a refill. If you have any questions, ask your||
8218|025|H|doctor or pharmacist.||
8218|026|H|   Take this medication by mouth with food as directed by your||
8218|027|H|doctor, usually twice daily (in the morning and evening). The||
8218|028|H|dosage is based on your medical condition and response to||
8218|029|H|treatment. To reduce your risk of side effects (such as nausea||
8218|030|H|and diarrhea), your doctor will start this medication at a low||
8218|031|H|dose and gradually increase your dose over 2 to 4 weeks.||
8218|032|H|   Use this medication regularly in order to get the most benefit||
8218|033|H|from it. To help you remember, take it at the same times each||
8218|034|H|day. Do not stop taking it unless your doctor instructs you to do||
8218|035|H|so. Do not use this drug more often than prescribed.||
8218|036|H|   If you do not take rivastigmine for 3 or more days in row,||
8218|037|H|talk with your doctor before starting again. You may need to||
8218|038|H|restart at a lower dose.||
8218|039|H|   Tell your doctor if your condition gets worse.||
8218|040|B|||
8218|041|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite/weight loss,||
8218|042|S|diarrhea, weakness, dizziness, drowsiness, and shakiness (tremor)||
8218|043|S|may occur as your body adjusts to the drug. These effects usually||
8218|044|S|occur when you start the medication or increase the dose and then||
8218|045|S|lessen. If any of these effects last or get worse, tell your||
8218|046|S|doctor or pharmacist promptly.||
8218|047|S|   Remember that this medication has been prescribed because your||
8218|048|S|doctor has judged that the benefit to you is greater than the||
8218|049|S|risk of side effects. Many people using this medication do not||
8218|050|S|have serious side effects.||
8218|051|S|   Tell your doctor right away if you have any serious side||
8218|052|S|effects, including: slow heartbeat, black stools, vomit that||
8218|053|S|looks like coffee grounds, severe stomach/abdominal pain,||
8218|054|S|seizures, trouble urinating.||
8218|055|S|   Get medical help right away if you have any very serious side||
8218|056|S|effects, including: fast/irregular heartbeat, severe dizziness,||
8218|057|S|fainting.||
8218|058|S|   A very serious allergic reaction to this drug is rare.||
8218|059|S|However, get medical help right away if you notice any symptoms||
8218|060|S|of a serious allergic reaction, including: rash, itching/swelling||
8218|061|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8218|062|S|breathing.||
8218|063|S|   This is not a complete list of possible side effects. If you||
8218|064|S|notice other effects not listed above, contact your doctor or||
8218|065|S|pharmacist.||
8218|066|S|   In the US -||
8218|067|S|   Call your doctor for medical advice about side effects. You||
8218|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8218|069|S|www.fda.gov/medwatch.||
8218|070|S|   In Canada - Call your doctor for medical advice about side||
8218|071|S|effects. You may report side effects to Health Canada at||
8218|072|S|1-866-234-2345.||
8218|073|B|||
8218|074|P|PRECAUTIONS:  Before taking rivastigmine, tell your doctor or||
8218|075|P|pharmacist if you are allergic to it (including having a rash||
8218|076|P|while using rivastigmine patches); or if you have any other||
8218|077|P|allergies. This product may contain inactive ingredients, which||
8218|078|P|can cause allergic reactions or other problems. Talk to your||
8218|079|P|pharmacist for more details.||
8218|080|P|   Before using this medication, tell your doctor or pharmacist||
8218|081|P|your medical history, especially of: breathing/lung problems||
8218|082|P|(such as asthma, COPD-chronic obstructive pulmonary disease),||
8218|083|P|stomach/intestinal problems (such as ulcers, bleeding), heart||
8218|084|P|disease (such as sick sinus syndrome, other conduction||
8218|085|P|disorders), fainting, seizures, problems urinating (such as due||
8218|086|P|to enlarged prostate).||
8218|087|P|   Rivastigmine may cause a condition that affects the heart||
8218|088|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8218|089|P|serious (rarely fatal) fast/irregular heartbeat and other||
8218|090|P|symptoms (such as severe dizziness, fainting) that need medical||
8218|091|P|attention right away.||
8218|092|P|   The risk of QT prolongation may be increased if you have||
8218|093|P|certain medical conditions or are taking other drugs that may||
8218|094|P|cause QT prolongation. Before using rivastigmine, tell your||
8218|095|P|doctor or pharmacist of all the drugs you take and if you have||
8218|096|P|any of the following conditions: certain heart problems (heart||
8218|097|P|failure, slow heartbeat, QT prolongation in the EKG), family||
8218|098|P|history of certain heart problems (QT prolongation in the EKG,||
8218|099|P|sudden cardiac death).||
8218|100|P|   Low levels of potassium or magnesium in the blood may also||
8218|101|P|increase your risk of QT prolongation. This risk may increase if||
8218|102|P|you use certain drugs (such as diuretics/"water pills") or if you||
8218|103|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8218|104|P|Talk to your doctor about using rivastigmine safely.||
8218|105|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8218|106|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8218|107|P|machinery, or do anything that needs alertness until you can do||
8218|108|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8218|109|P|are using marijuana (cannabis).||
8218|110|P|   Before having surgery, tell your doctor or dentist about all||
8218|111|P|the products you use (including prescription drugs,||
8218|112|P|nonprescription drugs, and herbal products).||
8218|113|P|   Older adults may be more sensitive to the side effects of this||
8218|114|P|drug, especially QT prolongation (see above).||
8218|115|P|   During pregnancy, this medication should be used only when||
8218|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
8218|117|P|   It is unknown if this medication passes into breast milk.||
8218|118|P|Consult your doctor before breastfeeding.||
8218|119|B|||
8218|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8218|121|I|medications work or increase your risk for serious side effects.||
8218|122|I|This document does not contain all possible drug interactions.||
8218|123|I|Keep a list of all the products you use (including||
8218|124|I|prescription/nonprescription drugs and herbal products) and share||
8218|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
8218|126|I|the dosage of any medicines without your doctor's approval.||
8218|127|I|   Some products that may interact with this drug include:||
8218|128|I|aspirin/nonsteroidal anti-inflammatory drugs (NSAIDs, such as||
8218|129|I|ibuprofen, naproxen), metoclopramide.||
8218|130|I|   Check all prescription and nonprescription medicine labels||
8218|131|I|carefully since many medications contain pain relievers/fever||
8218|132|I|reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that if||
8218|133|I|taken together with rivastigmine may increase your risk for||
8218|134|I|stomach/intestinal bleeding. However, if your doctor has told you||
8218|135|I|to take low-dose aspirin to prevent heart attack or stroke||
8218|136|I|(usually 81-162 milligrams a day), you should keep taking the||
8218|137|I|aspirin unless your doctor tells you not to. Ask your doctor or||
8218|138|I|pharmacist for more details.||
8218|139|B|||
8218|140|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8218|141|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8218|142|O|poison control center right away. US residents can call||
8218|143|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8218|144|O|Symptoms of overdose may include: nausea/vomiting that is severe||
8218|145|O|or doesn't stop, excessive sweating, very slow heartbeat, slow or||
8218|146|O|shallow breathing, seizures.||
8218|147|B|||
8218|148|N|NOTES:  Do not share this medication with others.||
8218|149|N|   Lab and/or medical tests (such as weight) should be done while||
8218|150|N|you are taking this medication. Keep all medical and lab||
8218|151|N|appointments. Consult your doctor for more details.||
8218|152|B|||
8218|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8218|154|D|remember. If it is near the time of the next dose, skip the||
8218|155|D|missed dose. Take your next dose at the regular time. Do not||
8218|156|D|double the dose to catch up.||
8218|157|B|||
8218|158|R|STORAGE:  Store at room temperature away from light and moisture.||
8218|159|R|Do not store in the bathroom. Keep all medications away from||
8218|160|R|children and pets.||
8218|161|R|   Do not flush medications down the toilet or pour them into a||
8218|162|R|drain unless instructed to do so. Properly discard this product||
8218|163|R|when it is expired or no longer needed. Consult your pharmacist||
8218|164|R|or local waste disposal company.||
8218|165|B|||
8218|166|A|Information last revised February 2025.||
8218|167|A|Copyright(c) 2025 First Databank, Inc.||
8218|168|B|||
8223|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8223|002|Z|does NOT have all possible information about this product. This||
8223|003|Z|information does not assure that this product is safe, effective,||
8223|004|Z|or appropriate for you. This information is not individual||
8223|005|Z|medical advice and does not substitute for the advice of your||
8223|006|Z|health care professional. Always ask your health care||
8223|007|Z|professional for complete information about this product and your||
8223|008|Z|specific health needs.||
8223|009|B|||
8223|010|T|CLARITHROMYCIN SUSPENSION - ORAL||
8223|011|F|(kla-RITH-roe-MYE-sin)||
8223|012|B|||
8223|013|C|COMMON BRAND NAME(S): Biaxin||
8223|014|B|||
8223|015|U|USES:  Clarithromycin is used to treat a wide variety of||
8223|016|U|bacterial infections. This medication can also be used in||
8223|017|U|combination with anti-ulcer medications to treat certain types of||
8223|018|U|stomach ulcers. It may also be used to prevent certain bacterial||
8223|019|U|infections. Clarithromycin is known as a macrolide antibiotic. It||
8223|020|U|works by stopping the growth of bacteria.||
8223|021|U|   This antibiotic treats only bacterial infections. It will not||
8223|022|U|work for viral infections (such as common cold, flu). Using any||
8223|023|U|antibiotic when it is not needed can cause it to not work for||
8223|024|U|future infections.||
8223|025|B|||
8223|026|H|HOW TO USE:  Take this medication by mouth with or without food||
8223|027|H|as directed by your doctor, usually every 12 hours. If stomach||
8223|028|H|upset occurs, you may take it with food or milk.||
8223|029|H|   Shake the bottle well before each dose. Carefully measure the||
8223|030|H|dose using a special measuring device/spoon. Do not use a||
8223|031|H|household spoon because you may not get the correct dose.||
8223|032|H|   For the best effect, take this antibiotic at evenly spaced||
8223|033|H|times. To help you remember, take this medication at the same||
8223|034|H|time(s) every day.||
8223|035|H|   The dosage and length of treatment are based on your medical||
8223|036|H|condition and response to treatment. Children's dosage may also||
8223|037|H|be based on weight.||
8223|038|H|   If you are using this medication to treat an infection,||
8223|039|H|continue to take this medication until the full prescribed amount||
8223|040|H|is finished, even if symptoms disappear after a few days.||
8223|041|H|Stopping the medication too early may result in a return of the||
8223|042|H|infection. Tell your doctor if your condition lasts or gets||
8223|043|H|worse.||
8223|044|H|   If you are taking this medication to prevent certain bacterial||
8223|045|H|infections, take it exactly as directed by your doctor. Do not||
8223|046|H|stop taking the medication without your doctor's approval. Tell||
8223|047|H|your doctor if you develop signs of infection such as fever or||
8223|048|H|night sweats.||
8223|049|B|||
8223|050|S|SIDE EFFECTS:  Diarrhea, nausea, vomiting, and changes in taste||
8223|051|S|may occur. If any of these effects last or get worse, tell your||
8223|052|S|doctor or pharmacist promptly.||
8223|053|S|   Remember that this medication has been prescribed because your||
8223|054|S|doctor has judged that the benefit to you is greater than the||
8223|055|S|risk of side effects. Many people using this medication do not||
8223|056|S|have serious side effects.||
8223|057|S|   Tell your doctor right away if you have any serious side||
8223|058|S|effects, including: signs of liver disease (such as||
8223|059|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
8223|060|S|yellowing eyes/skin, dark urine), hearing loss, mental/mood||
8223|061|S|changes, muscle weakness, eye problems (such as drooping eyelids,||
8223|062|S|blurred vision), trouble speaking.||
8223|063|S|   This medication may rarely cause a severe intestinal condition||
8223|064|S|due to a bacteria called C. difficile. This condition may occur||
8223|065|S|during treatment or weeks to months after treatment has stopped.||
8223|066|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8223|067|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8223|068|S|stool.||
8223|069|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8223|070|S|products because they may make symptoms worse.||
8223|071|S|   Use of this medication for prolonged or repeated periods may||
8223|072|S|result in oral thrush or a new yeast infection. Contact your||
8223|073|S|doctor if you notice white patches in your mouth, a change in||
8223|074|S|vaginal discharge, or other new symptoms.||
8223|075|S|   Get medical help right away if you have any very serious side||
8223|076|S|effects, including: severe dizziness, fainting, fast/irregular||
8223|077|S|heartbeat.||
8223|078|S|   A very serious allergic reaction to this drug is rare.||
8223|079|S|However, get medical help right away if you notice any symptoms||
8223|080|S|of a serious allergic reaction, including: fever that doesn't go||
8223|081|S|away, new or worsening lymph node swelling, rash,||
8223|082|S|itching/swelling (especially of the face/tongue/throat), severe||
8223|083|S|dizziness, trouble breathing.||
8223|084|S|   This is not a complete list of possible side effects. If you||
8223|085|S|notice other effects not listed above, contact your doctor or||
8223|086|S|pharmacist.||
8223|087|S|   In the US -||
8223|088|S|   Call your doctor for medical advice about side effects. You||
8223|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8223|090|S|www.fda.gov/medwatch.||
8223|091|S|   In Canada - Call your doctor for medical advice about side||
8223|092|S|effects. You may report side effects to Health Canada at||
8223|093|S|1-866-234-2345.||
8223|094|B|||
8223|095|P|PRECAUTIONS:  Before taking clarithromycin, tell your doctor or||
8223|096|P|pharmacist if you are allergic to it; or to other macrolide||
8223|097|P|antibiotics (such as erythromycin, azithromycin); or if you have||
8223|098|P|any other allergies. This product may contain inactive||
8223|099|P|ingredients, which can cause allergic reactions or other||
8223|100|P|problems. Talk to your pharmacist for more details.||
8223|101|P|   Before using this medication, tell your doctor or pharmacist||
8223|102|P|your medical history, especially of: liver disease (including||
8223|103|P|liver problems with past clarithromycin use), kidney disease,||
8223|104|P|heart disease (coronary artery disease, heart attack), a certain||
8223|105|P|type of muscle disease (myasthenia gravis).||
8223|106|P|   Clarithromycin may cause a condition that affects the heart||
8223|107|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8223|108|P|serious (rarely fatal) fast/irregular heartbeat and other||
8223|109|P|symptoms (such as severe dizziness, fainting) that need medical||
8223|110|P|attention right away.||
8223|111|P|   The risk of QT prolongation may be increased if you have||
8223|112|P|certain medical conditions or are taking other drugs that may||
8223|113|P|cause QT prolongation. Before using clarithromycin, tell your||
8223|114|P|doctor or pharmacist of all the drugs you take and if you have||
8223|115|P|any of the following conditions: certain heart problems (heart||
8223|116|P|failure, slow heartbeat, QT prolongation in the EKG), family||
8223|117|P|history of certain heart problems (QT prolongation in the EKG,||
8223|118|P|sudden cardiac death).||
8223|119|P|   Low levels of potassium or magnesium in the blood may also||
8223|120|P|increase your risk of QT prolongation. This risk may increase if||
8223|121|P|you use certain drugs (such as diuretics/"water pills") or if you||
8223|122|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8223|123|P|Talk to your doctor about using clarithromycin safely.||
8223|124|P|   Clarithromycin may cause live bacterial vaccines (such as||
8223|125|P|typhoid vaccine) to not work well. Tell your health care||
8223|126|P|professional that you are using clarithromycin before having any||
8223|127|P|immunizations/vaccinations.||
8223|128|P|   Before having surgery, tell your doctor or dentist about all||
8223|129|P|the products you use (including prescription drugs,||
8223|130|P|nonprescription drugs, and herbal products).||
8223|131|P|   Older adults may be more sensitive to the side effects of this||
8223|132|P|drug, especially hearing loss and QT prolongation (see above).||
8223|133|P|   During pregnancy, this medication should be used only when||
8223|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
8223|135|P|   This medication passes into breast milk. Consult your doctor||
8223|136|P|before breastfeeding.||
8223|137|B|||
8223|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8223|139|I|medications work or increase your risk for serious side effects.||
8223|140|I|This document does not contain all possible drug interactions.||
8223|141|I|Keep a list of all the products you use (including||
8223|142|I|prescription/nonprescription drugs and herbal products) and share||
8223|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
8223|144|I|the dosage of any medicines without your doctor's approval.||
8223|145|I|   Many drugs besides clarithromycin may affect the heart rhythm||
8223|146|I|(QT prolongation), including amiodarone, disopyramide,||
8223|147|I|dofetilide, pacritinib, pimozide, procainamide, quinidine,||
8223|148|I|sotalol, among others.||
8223|149|I|   Other medications can affect the removal of clarithromycin||
8223|150|I|from your body, which may affect how clarithromycin works.||
8223|151|I|Examples include efavirenz, nevirapine, posaconazole, rifamycins||
8223|152|I|(such as rifabutin), among others.||
8223|153|I|   Clarithromycin can slow down the removal of other medications||
8223|154|I|from your body, which may affect how they work. Examples of||
8223|155|I|affected drugs include colchicine, digoxin, some drugs used to||
8223|156|I|treat erectile dysfunction-ED/pulmonary hypertension (such as||
8223|157|I|sildenafil, tadalafil), ergot alkaloids (such as ergotamine,||
8223|158|I|dihydroergotamine), flibanserin, some statin drugs (such as||
8223|159|I|lovastatin, simvastatin), tamsulosin, tolvaptan, ticagrelor,||
8223|160|I|among others.||
8223|161|B|||
8223|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8223|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8223|164|O|poison control center right away. US residents can call||
8223|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8223|166|B|||
8223|167|N|NOTES:  Do not share this medication with others.||
8223|168|N|   This medication has been prescribed for your current condition||
8223|169|N|only. Do not use it later for another infection unless your||
8223|170|N|doctor tells you to.||
8223|171|N|   Lab and/or medical tests (such as cultures, liver/kidney||
8223|172|N|function) may be done while you are taking this medication. Keep||
8223|173|N|all medical and lab appointments. Consult your doctor for more||
8223|174|N|details.||
8223|175|B|||
8223|176|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8223|177|D|remember. If it is near the time of the next dose, skip the||
8223|178|D|missed dose. Take your next dose at the regular time. Do not||
8223|179|D|double the dose to catch up.||
8223|180|B|||
8223|181|R|STORAGE:  Store at room temperature. Do not refrigerate. Discard||
8223|182|R|any unused portion after 14 days. Keep all medications away from||
8223|183|R|children and pets.||
8223|184|R|   Do not flush medications down the toilet or pour them into a||
8223|185|R|drain unless instructed to do so. Properly discard this product||
8223|186|R|when it is expired or no longer needed. Consult your pharmacist||
8223|187|R|or local waste disposal company.||
8223|188|B|||
8223|189|A|Information last revised May 2025.||
8223|190|A|Copyright(c) 2025 First Databank, Inc.||
8223|191|B|||
8225|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8225|002|Z|does NOT have all possible information about this product. This||
8225|003|Z|information does not assure that this product is safe, effective,||
8225|004|Z|or appropriate for you. This information is not individual||
8225|005|Z|medical advice and does not substitute for the advice of your||
8225|006|Z|health care professional. Always ask your health care||
8225|007|Z|professional for complete information about this product and your||
8225|008|Z|specific health needs.||
8225|009|B|||
8225|010|T|NIMODIPINE - ORAL||
8225|011|F|(nye-MOE-di-peen)||
8225|012|B|||
8225|013|C|COMMON BRAND NAME(S): Nymalize||
8225|014|B|||
8225|015|W|WARNING:  This medication should not be given by injection.||
8225|016|W|Accidental injection of nimodipine can cause serious (rarely||
8225|017|W|fatal) side effects (such as low blood pressure, slow heartbeat).||
8225|018|W|Consult your doctor or pharmacist for details.||
8225|019|B|||
8225|020|U|USES:  Nimodipine is used to decrease problems due to a certain||
8225|021|U|type of bleeding in the brain (subarachnoid hemorrhage-SAH).||
8225|022|U|   Nimodipine is called a calcium channel blocker. The body||
8225|023|U|naturally responds to bleeding by narrowing the blood vessel to||
8225|024|U|slow blood flow. However, when the bleeding is in the brain,||
8225|025|U|stopping blood flow causes more brain damage. Nimodipine is||
8225|026|U|thought to work by relaxing narrowed blood vessels in the brain||
8225|027|U|near the area of bleeding so blood can flow more easily. This||
8225|028|U|effect reduces brain damage.||
8225|029|B|||
8225|030|V|OTHER USES:  This section contains uses of this drug that are not||
8225|031|V|listed in the approved professional labeling for the drug but||
8225|032|V|that may be prescribed by your health care professional. Use this||
8225|033|V|drug for a condition that is listed in this section only if it||
8225|034|V|has been so prescribed by your health care professional.||
8225|035|V|   This drug may also be used to decrease problems due to stroke.||
8225|036|B|||
8225|037|H|HOW TO USE:  See also Warning section.||
8225|038|H|   Read the Patient Information Leaflet if available from your||
8225|039|H|pharmacist before you start taking nimodipine and each time you||
8225|040|H|get a refill. If you have any questions, ask your doctor or||
8225|041|H|pharmacist.||
8225|042|H|   This medication is started as soon as possible after the start||
8225|043|H|of bleeding in the brain, usually within 4 days. Nimodipine is||
8225|044|H|taken as directed by your doctor, usually every 4 hours, 1 hour||
8225|045|H|before or 2 hours after a meal.||
8225|046|H|   If you are taking the tablet form of this medication, take it||
8225|047|H|by mouth with a full glass of water (8 ounces/240 milliliters),||
8225|048|H|unless your doctor tells you otherwise. Do not lie down for at||
8225|049|H|least 10 minutes after taking this medication. Swallow the tablet||
8225|050|H|whole. Do not crush.||
8225|051|H|   If you are taking the capsule form of this medication, take it||
8225|052|H|by mouth as directed by your doctor. Swallow the capsule whole.||
8225|053|H|If you cannot swallow a whole capsule, you may poke a hole in the||
8225|054|H|capsule, draw the liquid out with a syringe, and give it by mouth||
8225|055|H|or through a nasogastric tube with an oral syringe. Do not mix||
8225|056|H|the contents of the capsule with other liquids. Doing so may||
8225|057|H|prevent the medication from working. Do not inject this||
8225|058|H|medication.||
8225|059|H|   If you are using the liquid form (oral solution) of this||
8225|060|H|medication, carefully measure the dose using a special measuring||
8225|061|H|device/spoon. Do not use a household spoon because you may not||
8225|062|H|get the correct dose. Some brands of this medication may come in||
8225|063|H|a prefilled oral syringe with the exact dose. The liquid form may||
8225|064|H|also be given through a tube into the stomach (nasogastric or||
8225|065|H|gastric tube). If you are giving this medication through a||
8225|066|H|nasogastric or gastric tube, ask your health care professional||
8225|067|H|for detailed instructions on how to give it.||
8225|068|H|   Avoid eating grapefruit or drinking grapefruit juice while||
8225|069|H|using this medication unless your doctor or pharmacist says you||
8225|070|H|may do so safely. Grapefruit can increase the chance of side||
8225|071|H|effects with this medicine. Ask your doctor or pharmacist for||
8225|072|H|more details.||
8225|073|H|   The dosage is based on your medical condition and response to||
8225|074|H|treatment.||
8225|075|H|   Use this medication regularly to get the most benefit from it.||
8225|076|H|To help you remember, take it at the same times each day. Keep||
8225|077|H|taking this medication even if you feel well, and even if you do||
8225|078|H|not see any improvement in your symptoms. Consult your doctor or||
8225|079|H|pharmacist for details.||
8225|080|H|   Do not suddenly stop taking this medication without consulting||
8225|081|H|your doctor. This medication is usually taken for 2 to 4 weeks.||
8225|082|H|Follow your doctor's directions carefully. Your condition may||
8225|083|H|become worse if the drug is stopped too soon.||
8225|084|H|   Tell your doctor if your condition gets worse.||
8225|085|B|||
8225|086|S|SIDE EFFECTS:  Dizziness, lightheadedness, flushing, or swelling||
8225|087|S|ankles/feet may occur. If any of these effects last or get worse,||
8225|088|S|tell your doctor or pharmacist promptly.||
8225|089|S|   To reduce the risk of dizziness and lightheadedness, get up||
8225|090|S|slowly when rising from a sitting or lying position.||
8225|091|S|   Remember that this medication has been prescribed because your||
8225|092|S|doctor has judged that the benefit to you is greater than the||
8225|093|S|risk of side effects. Many people using this medication do not||
8225|094|S|have serious side effects.||
8225|095|S|   Tell your doctor right away if you have any serious side||
8225|096|S|effects, including: fainting, slow/fast heartbeat, severe||
8225|097|S|abdominal pain, stomach bloating, inability to have a bowel||
8225|098|S|movement for more than 3 days, severe nausea/vomiting, vision||
8225|099|S|changes.||
8225|100|S|   A very serious allergic reaction to this drug is rare.||
8225|101|S|However, get medical help right away if you notice any symptoms||
8225|102|S|of a serious allergic reaction, including: rash, itching/swelling||
8225|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8225|104|S|breathing.||
8225|105|S|   This is not a complete list of possible side effects. If you||
8225|106|S|notice other effects not listed above, contact your doctor or||
8225|107|S|pharmacist.||
8225|108|S|   In the US -||
8225|109|S|   Call your doctor for medical advice about side effects. You||
8225|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8225|111|S|www.fda.gov/medwatch.||
8225|112|S|   In Canada - Call your doctor for medical advice about side||
8225|113|S|effects. You may report side effects to Health Canada at||
8225|114|S|1-866-234-2345.||
8225|115|B|||
8225|116|P|PRECAUTIONS:  Before taking nimodipine, tell your doctor or||
8225|117|P|pharmacist if you are allergic to it; or to other dihydropyridine||
8225|118|P|calcium channel blockers (such as amlodipine, nifedipine); or if||
8225|119|P|you have any other allergies. This product may contain inactive||
8225|120|P|ingredients, which can cause allergic reactions or other||
8225|121|P|problems. Talk to your pharmacist for more details.||
8225|122|P|   Before using this medication, tell your doctor or pharmacist||
8225|123|P|your medical history, especially of: chest pain/recent heart||
8225|124|P|attack, low blood pressure, recent head injury, liver disease.||
8225|125|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8225|126|P|can make you more dizzy. Do not drive, use machinery, or do||
8225|127|P|anything that needs alertness until you can do it safely. Limit||
8225|128|P|alcoholic beverages. Talk to your doctor if you are using||
8225|129|P|marijuana (cannabis).||
8225|130|P|   Before having surgery, tell your doctor or dentist about all||
8225|131|P|the products you use (including prescription drugs,||
8225|132|P|nonprescription drugs, and herbal products).||
8225|133|P|   Older adults may be more sensitive to the side effects of this||
8225|134|P|drug, especially dizziness, or swelling of ankles/feet. Dizziness||
8225|135|P|can increase the risk of falling.||
8225|136|P|   During pregnancy, this medication should be used only when||
8225|137|P|clearly needed. Discuss the risks and benefits with your doctor.||
8225|138|P|   This medication passes into breast milk. Consult your doctor||
8225|139|P|before breastfeeding.||
8225|140|B|||
8225|141|I|DRUG INTERACTIONS:  See also How To Use section.||
8225|142|I|   Drug interactions may change how your medications work or||
8225|143|I|increase your risk for serious side effects. This document does||
8225|144|I|not contain all possible drug interactions. Keep a list of all||
8225|145|I|the products you use (including prescription/nonprescription||
8225|146|I|drugs and herbal products) and share it with your doctor and||
8225|147|I|pharmacist. Do not start, stop, or change the dosage of any||
8225|148|I|medicines without your doctor's approval.||
8225|149|I|   Other medications can affect the removal of nimodipine from||
8225|150|I|your body, which may affect how nimodipine works. Examples||
8225|151|I|include apalutamide, cimetidine, enzalutamide, ivosidenib,||
8225|152|I|lumacaftor, mitotane, azole antifungals (such as itraconazole),||
8225|153|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
8225|154|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
8225|155|I|as carbamazepine, phenytoin), among others.||
8225|156|I|   Some products have ingredients that could raise your heart||
8225|157|I|rate or blood pressure. Tell your pharmacist what products you||
8225|158|I|are using, and ask how to use them safely (especially||
8225|159|I|cough-and-cold products, diet aids, or NSAIDs such as||
8225|160|I|ibuprofen/naproxen).||
8225|161|B|||
8225|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8225|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8225|164|O|poison control center right away. US residents can call||
8225|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8225|166|B|||
8225|167|N|NOTES:  Do not share this medication with others.||
8225|168|N|   Lab and/or medical tests (such as liver function, blood||
8225|169|N|pressure, heart rate) may be done while you are taking this||
8225|170|N|medication. Keep all medical and lab appointments. Consult your||
8225|171|N|doctor for more details.||
8225|172|B|||
8225|173|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8225|174|D|remember. If it is near the time of the next dose, skip the||
8225|175|D|missed dose. Take your next dose at the regular time. Do not||
8225|176|D|double the dose to catch up.||
8225|177|B|||
8225|178|R|STORAGE:  Store at room temperature away from light and moisture.||
8225|179|R|Do not freeze. Do not store in the bathroom. Keep all medications||
8225|180|R|away from children and pets.||
8225|181|R|   Do not flush medications down the toilet or pour them into a||
8225|182|R|drain unless instructed to do so. Properly discard this product||
8225|183|R|when it is expired or no longer needed. Consult your pharmacist||
8225|184|R|or local waste disposal company.||
8225|185|B|||
8225|186|A|Information last revised November 2024.||
8225|187|A|Copyright(c) 2025 First Databank, Inc.||
8225|188|B|||
8226|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8226|002|Z|does NOT have all possible information about this product. This||
8226|003|Z|information does not assure that this product is safe, effective,||
8226|004|Z|or appropriate for you. This information is not individual||
8226|005|Z|medical advice and does not substitute for the advice of your||
8226|006|Z|health care professional. Always ask your health care||
8226|007|Z|professional for complete information about this product and your||
8226|008|Z|specific health needs.||
8226|009|B|||
8226|010|T|METHYL SALICYLATE/MENTHOL - TOPICAL||
8226|011|F|(METH-ill-sal-ISS-ill-ate/MEN-thall)||
8226|012|B|||
8226|013|C|COMMON BRAND NAME(S): BenGay, Icy Hot||
8226|014|B|||
8226|015|U|USES:  This product is used to treat minor aches and pains of the||
8226|016|U|muscles/joints (such as arthritis, backache, sprains). Menthol||
8226|017|U|and methyl salicylate are known as counterirritants. They work by||
8226|018|U|causing the skin to feel cool and then warm. These feelings on||
8226|019|U|the skin distract you from feeling the aches/pains deeper in your||
8226|020|U|muscles, joints, and tendons.||
8226|021|U|   Some products should not be used on children younger than 12||
8226|022|U|years without a doctor's advice. Check the label carefully before||
8226|023|U|using on children between 2 and 12 years old. Do not use on||
8226|024|U|children younger than 2 years.||
8226|025|B|||
8226|026|H|HOW TO USE:  Follow all directions on the product package. If you||
8226|027|H|have any questions, ask your doctor or pharmacist.||
8226|028|H|   This medication is for use on the skin only. Do not apply near||
8226|029|H|the eyes, mouth, nose, or genitals, and be careful not to touch||
8226|030|H|those areas while the medication is on your hands. If you do get||
8226|031|H|the medication in those areas, flush with plenty of water. Wash||
8226|032|H|your hands well before inserting contact lenses.||
8226|033|H|   Some products require shaking before use. Check your label to||
8226|034|H|see if your product needs to be shaken.||
8226|035|H|   Apply a thin layer of medication to the affected area no more||
8226|036|H|than 3 to 4 times a day. Rub in gently and thoroughly. After||
8226|037|H|applying the medication, wash your hands unless you are using||
8226|038|H|this medication to treat the hands. If treating the hands, wait||
8226|039|H|at least 30 minutes after applying the medication to wash your||
8226|040|H|hands.||
8226|041|H|   Do not apply this medication to skin that is injured or||
8226|042|H|irritated (such as cut, scraped, sunburned). Do not bandage or||
8226|043|H|tightly wrap the affected area. Doing so may increase the risk of||
8226|044|H|side effects. You may cover the area loosely to protect clothing.||
8226|045|H|Ask your pharmacist for more details.||
8226|046|H|   Heat can increase the risk of side effects. Do not apply this||
8226|047|H|medication immediately before, during, or after activities that||
8226|048|H|increase skin temperature (such as bathing in hot water,||
8226|049|H|swimming, sun bathing, heavy exercise) or in hot/humid weather.||
8226|050|H|Wait until your skin has cooled before applying the medication.||
8226|051|H|Do not use a sunlamp/tanning bed, hot water bottle, or heating||
8226|052|H|pad on the treated area.||
8226|053|H|   This product is available in different strengths and with||
8226|054|H|different ingredients but with product names that sound similar.||
8226|055|H|Read the label carefully to make sure you have the right product||
8226|056|H|for you. Ask your pharmacist if you have any questions.||
8226|057|H|   Tell your doctor if your condition lasts for more than 7 days,||
8226|058|H|if it gets worse, or if it keeps returning. If you think you may||
8226|059|H|have a serious medical problem, get medical help right away.||
8226|060|B|||
8226|061|S|SIDE EFFECTS:  Redness, warmth, stinging, or burning on the||
8226|062|S|application site may occur. If any of these effects last or get||
8226|063|S|worse, tell your doctor or pharmacist promptly.||
8226|064|S|   If your doctor has directed you to use this medication,||
8226|065|S|remember that your doctor has judged that the benefit to you is||
8226|066|S|greater than the risk of side effects. Many people using this||
8226|067|S|medication do not have serious side effects.||
8226|068|S|   Stop using this medication and tell your doctor right away if||
8226|069|S|you have any serious side effects, including:||
8226|070|S|blistering/swelling/severe redness at the application site,||
8226|071|S|increased/unusual pain at the application site, nausea/vomiting,||
8226|072|S|ringing in the ears.||
8226|073|S|   A very serious allergic reaction to this drug is rare.||
8226|074|S|However, get medical help right away if you notice any symptoms||
8226|075|S|of a serious allergic reaction, including: rash, itching/swelling||
8226|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8226|077|S|breathing.||
8226|078|S|   This is not a complete list of possible side effects. If you||
8226|079|S|notice other effects not listed above, contact your doctor or||
8226|080|S|pharmacist.||
8226|081|S|   In the US -||
8226|082|S|   Call your doctor for medical advice about side effects. You||
8226|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8226|084|S|www.fda.gov/medwatch.||
8226|085|S|   In Canada - Call your doctor for medical advice about side||
8226|086|S|effects. You may report side effects to Health Canada at||
8226|087|S|1-866-234-2345.||
8226|088|B|||
8226|089|P|PRECAUTIONS:  Before using this product, tell your doctor or||
8226|090|P|pharmacist if you are allergic to menthol or methyl salicylate;||
8226|091|P|or to aspirin or other salicylates (such as salsalate); or if you||
8226|092|P|have any other allergies. This product may contain inactive||
8226|093|P|ingredients, which can cause allergic reactions or other||
8226|094|P|problems. Talk to your pharmacist for more details.||
8226|095|P|   If you have any of the following health problems, consult your||
8226|096|P|doctor or pharmacist before using this product: asthma, growths||
8226|097|P|in the nose (nasal polyps).||
8226|098|P|   Before having surgery, tell your doctor or dentist about all||
8226|099|P|the products you use (including prescription drugs,||
8226|100|P|nonprescription drugs, and herbal products).||
8226|101|P|   This drug contains an aspirin-like product (salicylate).||
8226|102|P|Children and teenagers younger than 18 years should not use this||
8226|103|P|product if they have chickenpox, flu, or any undiagnosed illness||
8226|104|P|or if they have recently received a vaccine. In these cases,||
8226|105|P|using aspirin or aspirin-like products increases the risk of||
8226|106|P|Reye's syndrome, a rare but serious illness.||
8226|107|P|   Tell your doctor if you are pregnant or if you plan to become||
8226|108|P|pregnant. This medication may harm an unborn baby and cause||
8226|109|P|problems with normal labor/delivery. It is not recommended for||
8226|110|P|use in pregnancy from 20 weeks until delivery. If your doctor||
8226|111|P|decides that you need to use this medication between 20 and 30||
8226|112|P|weeks of pregnancy, you should use the lowest effective dose for||
8226|113|P|the shortest possible time. You should not use this medication||
8226|114|P|after 30 weeks of pregnancy. Discuss the risks and benefits with||
8226|115|P|your doctor.||
8226|116|P|   It is unknown if this product passes into breast milk. Consult||
8226|117|P|your doctor before breastfeeding.||
8226|118|B|||
8226|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8226|120|I|medications work or increase your risk for serious side effects.||
8226|121|I|This document does not contain all possible drug interactions.||
8226|122|I|Keep a list of all the products you use (including||
8226|123|I|prescription/nonprescription drugs and herbal products) and share||
8226|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
8226|125|I|the dosage of any medicines without your doctor's approval.||
8226|126|B|||
8226|127|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8226|128|O|has overdosed and has serious symptoms such as passing out or||
8226|129|O|trouble breathing, call 911. Otherwise, call a poison control||
8226|130|O|center right away. US residents can call 1-800-222-1222. Canada||
8226|131|O|residents can call 1-844-764-7669.||
8226|132|B|||
8226|133|N|NOTES:  Keep all medical and lab appointments.||
8226|134|B|||
8226|135|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8226|136|D|If it is near the time of the next dose, skip the missed dose.||
8226|137|D|Use your next dose at the regular time. Do not double the dose to||
8226|138|D|catch up.||
8226|139|B|||
8226|140|R|STORAGE:  Different brands of this medication have different||
8226|141|R|storage needs. Check the product package for instructions on how||
8226|142|R|to store your brand, or ask your pharmacist. Keep all medications||
8226|143|R|away from children and pets.||
8226|144|R|   Do not flush medications down the toilet or pour them into a||
8226|145|R|drain unless instructed to do so. Properly discard this product||
8226|146|R|when it is expired or no longer needed. Consult your pharmacist||
8226|147|R|or local waste disposal company.||
8226|148|B|||
8226|149|A|Information last revised September 2025.||
8226|150|A|Copyright(c) 2025 First Databank, Inc.||
8226|151|B|||
8230|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8230|002|Z|does NOT have all possible information about this product. This||
8230|003|Z|information does not assure that this product is safe, effective,||
8230|004|Z|or appropriate for you. This information is not individual||
8230|005|Z|medical advice and does not substitute for the advice of your||
8230|006|Z|health care professional. Always ask your health care||
8230|007|Z|professional for complete information about this product and your||
8230|008|Z|specific health needs.||
8230|009|B|||
8230|010|T|TAZAROTENE CREAM - TOPICAL||
8230|011|F|(taz-AR-oh-teen)||
8230|012|B|||
8230|013|C|COMMON BRAND NAME(S): Avage, Tazorac||
8230|014|B|||
8230|015|U|USES:  This medication is used to treat certain skin conditions,||
8230|016|U|including psoriasis, acne, and skin aging symptoms due to sun||
8230|017|U|damage (such as wrinkles and dark or light spots on your face).||
8230|018|U|Different brands and strengths are approved for different uses,||
8230|019|U|so be sure to check the uses for your brand and strength of this||
8230|020|U|medication. Tazarotene is a retinoid product related to Vitamin||
8230|021|U|A. It is thought to work by affecting skin cell growth. For the||
8230|022|U|best effect, this medication should be used with a total skin||
8230|023|U|care program.||
8230|024|B|||
8230|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8230|026|H|from your pharmacist before you start using tazarotene and each||
8230|027|H|time you get a refill. If you have any questions, ask your doctor||
8230|028|H|or pharmacist.||
8230|029|H|   This medication is for use on the skin only. Apply this||
8230|030|H|medication to the skin as directed by your doctor, usually once||
8230|031|H|daily at bedtime. Wash your hands after applying, unless you are||
8230|032|H|treating your hands for psoriasis. If this medication||
8230|033|H|accidentally gets on areas you do not need to treat, wash it off||
8230|034|H|to help prevent skin irritation. Do not apply this medication to||
8230|035|H|skin that is cut, scraped, sunburned, or affected by certain||
8230|036|H|other skin conditions (eczema, seborrheic dermatitis). Avoid||
8230|037|H|getting this medication in your eyes or mouth. If this happens,||
8230|038|H|rinse right away with plenty of cool water.||
8230|039|H|   If you are using this product to treat psoriasis, apply a thin||
8230|040|H|film to cover only the psoriatic plaques. If a bath or shower is||
8230|041|H|taken before application, make sure skin is dry before applying.||
8230|042|H|If a moisturizer is used, apply it at least an hour before||
8230|043|H|applying this medication.||
8230|044|H|   If you are using this product to treat acne, wash and dry the||
8230|045|H|affected area(s). After skin is dry, apply enough to cover all of||
8230|046|H|the affected area(s).||
8230|047|H|   If you are using this product to treat skin aging symptoms due||
8230|048|H|to sun damage, wash and dry your hands before applying the||
8230|049|H|medication, then clean your face with a mild cleanser and pat||
8230|050|H|dry. After skin is dry, apply a pea-sized amount of this||
8230|051|H|medication to the affected areas on your face as directed by your||
8230|052|H|doctor, usually once daily at bedtime. You may use a moisturizing||
8230|053|H|cream or lotion on you face before or after you apply this||
8230|054|H|medication. Make sure that either the moisturizer or medication||
8230|055|H|has been absorbed into your skin before you apply the second||
8230|056|H|product.||
8230|057|H|   Use this medication regularly to get the most benefit from it.||
8230|058|H|To help you remember, use it at the same time each day.||
8230|059|H|   Do not use large amounts or apply this medication more often||
8230|060|H|or use for longer than prescribed. Your condition will not||
8230|061|H|improve faster, and your risk of side effects will increase.||
8230|062|H|   Since this drug is absorbed through the skin and may harm an||
8230|063|H|unborn baby, women who are pregnant or who may become pregnant||
8230|064|H|should not handle this medication.||
8230|065|H|   Tell your doctor if your condition does not get better or if||
8230|066|H|it gets worse.||
8230|067|B|||
8230|068|S|SIDE EFFECTS:  Itching, burning/stinging, redness, irritation,||
8230|069|S|dryness, or peeling of the skin may occur. If any of these||
8230|070|S|effects last or get worse, tell your doctor or pharmacist||
8230|071|S|promptly.||
8230|072|S|   Remember that this medication has been prescribed because your||
8230|073|S|doctor has judged that the benefit to you is greater than the||
8230|074|S|risk of side effects. Many people using this medication do not||
8230|075|S|have serious side effects.||
8230|076|S|   Tell your doctor right away if you have any serious side||
8230|077|S|effects, including: skin rash or cracking, discoloration or||
8230|078|S|bleeding of the skin.||
8230|079|S|   A very serious allergic reaction to this drug is rare.||
8230|080|S|However, get medical help right away if you notice any symptoms||
8230|081|S|of a serious allergic reaction, including: rash, severe||
8230|082|S|itching/swelling (especially of the face/tongue/throat), severe||
8230|083|S|dizziness, trouble breathing.||
8230|084|S|   This is not a complete list of possible side effects. If you||
8230|085|S|notice other effects not listed above, contact your doctor or||
8230|086|S|pharmacist.||
8230|087|S|   In the US -||
8230|088|S|   Call your doctor for medical advice about side effects. You||
8230|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8230|090|S|www.fda.gov/medwatch.||
8230|091|S|   In Canada - Call your doctor for medical advice about side||
8230|092|S|effects. You may report side effects to Health Canada at||
8230|093|S|1-866-234-2345.||
8230|094|B|||
8230|095|P|PRECAUTIONS:  Before using tazarotene, tell your doctor or||
8230|096|P|pharmacist if you are allergic to it; or to vitamin A-related||
8230|097|P|drugs (other retinoids such as isotretinoin); or if you have any||
8230|098|P|other allergies. This product may contain inactive ingredients,||
8230|099|P|which can cause allergic reactions or other problems. Talk to||
8230|100|P|your pharmacist for more details.||
8230|101|P|   Before using this medication, tell your doctor or pharmacist||
8230|102|P|your medical history, especially of: other skin conditions (such||
8230|103|P|as eczema, seborrheic dermatitis, sunburn, sun sensitivity).||
8230|104|P|   This medication may make you more sensitive to the sun. Limit||
8230|105|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8230|106|P|sunscreen daily and wear protective clothing when outdoors. Tell||
8230|107|P|your doctor right away if you get sunburned or have skin||
8230|108|P|blisters/redness. Wait until your skin has completely recovered||
8230|109|P|from a sunburn before using this medication. Wind or cold weather||
8230|110|P|may also be more irritating to the skin while using this||
8230|111|P|medication.||
8230|112|P|   Avoid electrolysis, waxing, and chemical depilatories for hair||
8230|113|P|removal on the treated areas while using this product.||
8230|114|P|   Before having surgery, tell your doctor or dentist about all||
8230|115|P|the products you use (including prescription drugs,||
8230|116|P|nonprescription drugs, and herbal products).||
8230|117|P|   This medication must not be used during pregnancy. It may harm||
8230|118|P|an unborn baby. Your doctor may order a pregnancy test within 2||
8230|119|P|weeks before starting this medication. This medication should be||
8230|120|P|started during a normal menstrual period. Discuss the use of||
8230|121|P|reliable forms of birth control (such as condoms, birth control||
8230|122|P|pills) with your doctor. If you become pregnant or think you may||
8230|123|P|be pregnant, tell your doctor right away.||
8230|124|P|   Since this drug is absorbed through the skin and may harm an||
8230|125|P|unborn baby, women who are pregnant or who may become pregnant||
8230|126|P|should not handle this medication.||
8230|127|P|   It is unknown if this drug passes into breast milk. Consult||
8230|128|P|your doctor before breastfeeding.||
8230|129|B|||
8230|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8230|131|I|medications work or increase your risk for serious side effects.||
8230|132|I|This document does not contain all possible drug interactions.||
8230|133|I|Keep a list of all the products you use (including||
8230|134|I|prescription/nonprescription drugs and herbal products) and share||
8230|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
8230|136|I|the dosage of any medicines without your doctor's approval.||
8230|137|I|   Some products that may interact with this drug are: vitamin A||
8230|138|I|products, hair perming solutions, other skin products with strong||
8230|139|I|drying effects, skin products containing alcohol/lime/spice (such||
8230|140|I|as shaving lotions, astringents such as calamine lotion,||
8230|141|I|perfume), soaps/shampoos/cleansers that are medicated/abrasive.||
8230|142|B|||
8230|143|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8230|144|O|has overdosed and has serious symptoms such as passing out or||
8230|145|O|trouble breathing, call 911. Otherwise, call a poison control||
8230|146|O|center right away. US residents can call 1-800-222-1222. Canada||
8230|147|O|residents can call 1-844-764-7669. Symptoms of overdose may||
8230|148|O|include: increased skin dryness and peeling.||
8230|149|B|||
8230|150|N|NOTES:  Do not share this medication with others.||
8230|151|B|||
8230|152|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
8230|153|D|remember. If it is near the time of the next dose, skip the||
8230|154|D|missed dose. Apply your next dose at the regular time. Do not||
8230|155|D|apply extra medicine to make up for the missed dose.||
8230|156|B|||
8230|157|R|STORAGE:  Store at room temperature. Keep all medications away||
8230|158|R|from children and pets.||
8230|159|R|   Do not flush medications down the toilet or pour them into a||
8230|160|R|drain unless instructed to do so. Properly discard this product||
8230|161|R|when it is expired or no longer needed. Consult your pharmacist||
8230|162|R|or local waste disposal company.||
8230|163|B|||
8230|164|A|Information last revised October 2024.||
8230|165|A|Copyright(c) 2025 First Databank, Inc.||
8230|166|B|||
8235|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8235|002|Z|does NOT have all possible information about this product. This||
8235|003|Z|information does not assure that this product is safe, effective,||
8235|004|Z|or appropriate for you. This information is not individual||
8235|005|Z|medical advice and does not substitute for the advice of your||
8235|006|Z|health care professional. Always ask your health care||
8235|007|Z|professional for complete information about this product and your||
8235|008|Z|specific health needs.||
8235|009|B|||
8235|010|T|LEVOFLOXACIN - ORAL||
8235|011|F|(LEE-voe-FLOX-a-sin)||
8235|012|B|||
8235|013|C|COMMON BRAND NAME(S): Levaquin||
8235|014|B|||
8235|015|W|WARNING:  Quinolone antibiotics (including levofloxacin) may||
8235|016|W|cause serious and possibly permanent tendon damage (such as||
8235|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
8235|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
8235|019|W|help right away if you have any of the following symptoms:||
8235|020|W|pain/numbness/burning/tingling/weakness in your||
8235|021|W|arms/hands/legs/feet, changes in how you sense||
8235|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
8235|023|W|headache, vision changes, shaking (tremors), seizures,||
8235|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
8235|025|W|hallucinations, depression, rare thoughts of suicide).||
8235|026|W|   Tendon damage may occur during or after treatment with this||
8235|027|W|medication. Stop exercising, rest, and get medical help right||
8235|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
8235|029|W|risk for tendon problems is greater if you are over 60 years of||
8235|030|W|age, if you are taking corticosteroids (such as prednisone), or||
8235|031|W|if you have a kidney, heart, or lung transplant.||
8235|032|W|   This medication may make a certain muscle condition||
8235|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
8235|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
8235|035|W|unsteady walk) or trouble breathing.||
8235|036|W|   Discuss the risks and benefits with your doctor before using||
8235|037|W|this medication.||
8235|038|B|||
8235|039|U|USES:  Levofloxacin is used to treat a variety of bacterial||
8235|040|U|infections. This medication belongs to a class of drugs known as||
8235|041|U|quinolone antibiotics. It works by stopping the growth of||
8235|042|U|bacteria.||
8235|043|U|   This antibiotic treats only bacterial infections. It will not||
8235|044|U|work for viral infections (such as common cold, flu). Using any||
8235|045|U|antibiotic when it is not needed can cause it to not work for||
8235|046|U|future infections.||
8235|047|B|||
8235|048|H|HOW TO USE:  Read the Medication Guide provided by your||
8235|049|H|pharmacist before you start taking levofloxacin and each time you||
8235|050|H|get a refill. If you have any questions, ask your doctor or||
8235|051|H|pharmacist.||
8235|052|H|   Take this medication by mouth with or without food as directed||
8235|053|H|by your doctor, usually once daily. Drink plenty of fluids while||
8235|054|H|taking this medication unless otherwise directed by your doctor.||
8235|055|H|   Take this medication at least 2 hours before or 2 hours after||
8235|056|H|taking other products that may make it work less well. Examples||
8235|057|H|include quinapril, sucralfate, vitamins/minerals (including iron,||
8235|058|H|zinc), and products that contain magnesium, aluminum, or calcium||
8235|059|H|(such as antacids, juice with added calcium), among others. Ask||
8235|060|H|your pharmacist about all the products you take.||
8235|061|H|   The dosage and length of treatment are based on your medical||
8235|062|H|condition and response to treatment. Children's dosage is also||
8235|063|H|based on weight.||
8235|064|H|   For the best effect, take this antibiotic at evenly spaced||
8235|065|H|times. To help you remember, take this medication at the same||
8235|066|H|time every day.||
8235|067|H|   Continue to take this medication until the full prescribed||
8235|068|H|amount is finished, even if symptoms disappear after a few days.||
8235|069|H|Stopping the medication too early may result in a return of the||
8235|070|H|infection.||
8235|071|H|   Tell your doctor if your condition lasts or gets worse.||
8235|072|B|||
8235|073|S|SIDE EFFECTS:  See also Warning section.||
8235|074|S|   Nausea, diarrhea, headache, dizziness, lightheadedness, or||
8235|075|S|trouble sleeping may occur. If any of these effects last or get||
8235|076|S|worse, tell your doctor or pharmacist promptly.||
8235|077|S|   Remember that this medication has been prescribed because your||
8235|078|S|doctor has judged that the benefit to you is greater than the||
8235|079|S|risk of side effects. Many people using this medication do not||
8235|080|S|have serious side effects.||
8235|081|S|   Tell your doctor right away if you have any serious side||
8235|082|S|effects, including: unusual bruising/bleeding, signs of kidney||
8235|083|S|problems (such as change in the amount of urine), signs of liver||
8235|084|S|problems (such as nausea/vomiting that doesn't stop, loss of||
8235|085|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
8235|086|S|urine).||
8235|087|S|   Get medical help right away if you have any very serious side||
8235|088|S|effects, including: chest pain, severe dizziness, fainting,||
8235|089|S|fast/irregular heartbeat, signs of a tear/break in the main blood||
8235|090|S|vessel called the aorta (such as sudden/severe pain in the||
8235|091|S|stomach/chest/back, shortness of breath).||
8235|092|S|   This medication may rarely cause a severe intestinal condition||
8235|093|S|due to a bacteria called C. difficile. This condition may occur||
8235|094|S|during treatment or weeks to months after treatment has stopped.||
8235|095|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8235|096|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8235|097|S|stool.||
8235|098|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8235|099|S|products because they may make symptoms worse.||
8235|100|S|   Use of this medication for prolonged or repeated periods may||
8235|101|S|result in oral thrush or a new yeast infection. Contact your||
8235|102|S|doctor if you notice white patches in your mouth, a change in||
8235|103|S|vaginal discharge, or other new symptoms.||
8235|104|S|   A very serious allergic reaction to this drug is rare.||
8235|105|S|However, get medical help right away if you notice any symptoms||
8235|106|S|of a serious allergic reaction, including: rash, itching/swelling||
8235|107|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8235|108|S|breathing.||
8235|109|S|   This is not a complete list of possible side effects. If you||
8235|110|S|notice other effects not listed above, contact your doctor or||
8235|111|S|pharmacist.||
8235|112|S|   In the US -||
8235|113|S|   Call your doctor for medical advice about side effects. You||
8235|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8235|115|S|www.fda.gov/medwatch.||
8235|116|S|   In Canada - Call your doctor for medical advice about side||
8235|117|S|effects. You may report side effects to Health Canada at||
8235|118|S|1-866-234-2345.||
8235|119|B|||
8235|120|P|PRECAUTIONS:  Before taking levofloxacin, tell your doctor or||
8235|121|P|pharmacist if you are allergic to it; or to other quinolone||
8235|122|P|antibiotics (such as ciprofloxacin, moxifloxacin, ofloxacin); or||
8235|123|P|if you have any other allergies. This product may contain||
8235|124|P|inactive ingredients, which can cause allergic reactions or other||
8235|125|P|problems. Talk to your pharmacist for more details.||
8235|126|P|   Before using this medication, tell your doctor or pharmacist||
8235|127|P|your medical history, especially of: diabetes, joint/tendon||
8235|128|P|problems (such as tendonitis, bursitis), kidney problems,||
8235|129|P|mental/mood disorders (such as depression), a certain muscle||
8235|130|P|condition (myasthenia gravis), nerve problems (such as peripheral||
8235|131|P|neuropathy), seizure disorder, blood vessel problems (such as||
8235|132|P|aneurysm or blockage of the aorta or other blood vessels,||
8235|133|P|hardening of the arteries), high blood pressure, certain genetic||
8235|134|P|conditions (Marfan syndrome, Ehlers-Danlos syndrome).||
8235|135|P|   Levofloxacin may cause a condition that affects the heart||
8235|136|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8235|137|P|serious (rarely fatal) fast/irregular heartbeat and other||
8235|138|P|symptoms (such as severe dizziness, fainting) that need medical||
8235|139|P|attention right away.||
8235|140|P|   The risk of QT prolongation may be increased if you have||
8235|141|P|certain medical conditions or are taking other drugs that may||
8235|142|P|cause QT prolongation. Before using levofloxacin, tell your||
8235|143|P|doctor or pharmacist of all the drugs you take and if you have||
8235|144|P|any of the following conditions: certain heart problems (heart||
8235|145|P|failure, slow heartbeat, QT prolongation in the EKG), family||
8235|146|P|history of certain heart problems (QT prolongation in the EKG,||
8235|147|P|sudden cardiac death).||
8235|148|P|   Low levels of potassium or magnesium in the blood may also||
8235|149|P|increase your risk of QT prolongation. This risk may increase if||
8235|150|P|you use certain drugs (such as diuretics/"water pills") or if you||
8235|151|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8235|152|P|Talk to your doctor about using levofloxacin safely.||
8235|153|P|   Levofloxacin may rarely cause serious changes in blood sugar,||
8235|154|P|especially if you have diabetes. Check your blood sugar regularly||
8235|155|P|as directed and share the results with your doctor. Watch for||
8235|156|P|symptoms of high blood sugar such as increased thirst/urination.||
8235|157|P|Also watch for symptoms of low blood sugar such as sudden||
8235|158|P|sweating, shaking, fast heartbeat, hunger, blurred vision,||
8235|159|P|dizziness, or tingling hands/feet. It is a good habit to carry||
8235|160|P|glucose tablets or gel to treat low blood sugar. If you don't||
8235|161|P|have these reliable forms of glucose, rapidly raise your blood||
8235|162|P|sugar by eating a quick source of sugar such as table sugar,||
8235|163|P|honey, or candy, or by drinking fruit juice or non-diet soda.||
8235|164|P|Tell your doctor right away about the reaction and the use of||
8235|165|P|this product. To help prevent low blood sugar, eat meals on a||
8235|166|P|regular schedule, and no not skip meals. Your doctor may need to||
8235|167|P|switch you to another antibiotic or adjust your diabetes||
8235|168|P|medications if any reaction occurs.||
8235|169|P|   This drug may make you dizzy or lightheaded. Alcohol or||
8235|170|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
8235|171|P|machinery, or do anything that needs alertness until you can do||
8235|172|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8235|173|P|are using marijuana (cannabis).||
8235|174|P|   This medication may make you more sensitive to the sun. Limit||
8235|175|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8235|176|P|sunscreen and wear protective clothing when outdoors. Tell your||
8235|177|P|doctor right away if you get sunburned or have skin||
8235|178|P|blisters/redness.||
8235|179|P|   Levofloxacin may cause live bacterial vaccines (such as||
8235|180|P|typhoid vaccine) to not work well. Tell your health care||
8235|181|P|professional that you are using levofloxacin before having any||
8235|182|P|immunizations/vaccinations.||
8235|183|P|   Before having surgery, tell your doctor or dentist about all||
8235|184|P|the products you use (including prescription drugs,||
8235|185|P|nonprescription drugs, and herbal products).||
8235|186|P|   Children may be at greater risk for joint/tendon problems||
8235|187|P|while using this drug. Discuss the risks and benefits with the||
8235|188|P|doctor.||
8235|189|P|   Older adults may be at greater risk for tendon problems||
8235|190|P|(especially if they are also taking corticosteroids such as||
8235|191|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
8235|192|P|tear/break in the main blood vessel (aorta).||
8235|193|P|   During pregnancy, this medication should be used only when||
8235|194|P|clearly needed. Discuss the risks and benefits with your doctor.||
8235|195|P|   This drug passes into breast milk. Consult your doctor before||
8235|196|P|breastfeeding.||
8235|197|B|||
8235|198|I|DRUG INTERACTIONS:  See also How to Use section.||
8235|199|I|   Drug interactions may change how your medications work or||
8235|200|I|increase your risk for serious side effects. This document does||
8235|201|I|not contain all possible drug interactions. Keep a list of all||
8235|202|I|the products you use (including prescription/nonprescription||
8235|203|I|drugs and herbal products) and share it with your doctor and||
8235|204|I|pharmacist. Do not start, stop, or change the dosage of any||
8235|205|I|medicines without your doctor's approval.||
8235|206|I|   A product that may interact with this drug is: strontium.||
8235|207|I|   Levofloxacin is very similar to ofloxacin. Do not use||
8235|208|I|medications containing ofloxacin while using levofloxacin.||
8235|209|I|   This medication may interfere with certain lab tests (such as||
8235|210|I|urine screening for opiates), possibly causing false test||
8235|211|I|results. Make sure lab personnel and all your doctors know you||
8235|212|I|use this drug.||
8235|213|B|||
8235|214|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8235|215|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8235|216|O|poison control center right away. US residents can call||
8235|217|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8235|218|O|Symptoms of overdose may include: severe dizziness.||
8235|219|B|||
8235|220|N|NOTES:  Do not share this medication with others.||
8235|221|N|   This medication has been prescribed for your current condition||
8235|222|N|only. Do not use it later for another infection unless your||
8235|223|N|doctor tells you to.||
8235|224|N|   Lab tests (such as kidney function, complete blood count,||
8235|225|N|blood sugar, cultures) may be done before you start taking this||
8235|226|N|medication and while you are taking it. Keep all medical and lab||
8235|227|N|appointments.||
8235|228|B|||
8235|229|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8235|230|D|remember. If it is within 8 hours of the next dose, skip the||
8235|231|D|missed dose. Take your next dose at the regular time. Do not||
8235|232|D|double the dose to catch up.||
8235|233|B|||
8235|234|R|STORAGE:  Store at room temperature away from light and moisture.||
8235|235|R|Do not store in the bathroom. Keep all medications away from||
8235|236|R|children and pets.||
8235|237|R|   Do not flush medications down the toilet or pour them into a||
8235|238|R|drain unless instructed to do so. Properly discard this product||
8235|239|R|when it is expired or no longer needed. Consult your pharmacist||
8235|240|R|or local waste disposal company.||
8235|241|B|||
8235|242|A|Information last revised September 2025.||
8235|243|A|Copyright(c) 2025 First Databank, Inc.||
8235|244|B|||
8238|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8238|002|Z|does NOT have all possible information about this product. This||
8238|003|Z|information does not assure that this product is safe, effective,||
8238|004|Z|or appropriate for you. This information is not individual||
8238|005|Z|medical advice and does not substitute for the advice of your||
8238|006|Z|health care professional. Always ask your health care||
8238|007|Z|professional for complete information about this product and your||
8238|008|Z|specific health needs.||
8238|009|B|||
8238|010|T|DEXTROMETHORPHAN LIQUID - ORAL||
8238|011|F|(dex-trow-meth-OR-fan)||
8238|012|B|||
8238|013|C|COMMON BRAND NAME(S): Benylin, Creomulsion, Delsym||
8238|014|B|||
8238|015|U|USES:  This medication is used for temporary relief of coughs||
8238|016|U|without phlegm that are caused by certain infections of the air||
8238|017|U|passages (such as sinusitis, common cold). This product should||
8238|018|U|not usually be used for an ongoing cough from smoking or||
8238|019|U|long-term breathing problems (such as chronic bronchitis,||
8238|020|U|emphysema) unless directed by your doctor. This product contains||
8238|021|U|dextromethorphan. It is a cough suppressant that works by||
8238|022|U|decreasing the feeling of needing to cough.||
8238|023|U|   Cough-and-cold products have not been shown to be safe or||
8238|024|U|effective in children younger than 6 years. Do not use this||
8238|025|U|product to treat cold symptoms in children younger than 6 years||
8238|026|U|unless specifically directed by the doctor. Ask your doctor or||
8238|027|U|pharmacist for more details about using your product safely.||
8238|028|U|   These products do not cure or shorten the length of the common||
8238|029|U|cold and may cause serious side effects. To decrease the risk for||
8238|030|U|serious side effects, carefully follow all dosage directions. Do||
8238|031|U|not use this product to make a child sleepy. Do not give other||
8238|032|U|cough-and-cold medication that might contain the same or similar||
8238|033|U|ingredients (see also Drug Interactions section). Ask the doctor||
8238|034|U|or pharmacist about other ways to relieve cough and cold symptoms||
8238|035|U|(such as drinking enough fluids, using a humidifier or saline||
8238|036|U|nose drops/spray).||
8238|037|B|||
8238|038|H|HOW TO USE:  Take this medication by mouth, usually every 4 to 12||
8238|039|H|hours as needed or as directed by your doctor. If stomach upset||
8238|040|H|occurs, take with food or milk. Use a medication-measuring device||
8238|041|H|to measure your dose of liquid medication. Do not use a household||
8238|042|H|spoon because you may not get the correct dose. If you are taking||
8238|043|H|a suspension, shake the product well before measuring out your||
8238|044|H|dose.||
8238|045|H|   Dosage is based on the product you are taking and your age,||
8238|046|H|medical condition, and response to treatment. If you are using||
8238|047|H|this medication for self-treatment (without a prescription from||
8238|048|H|your doctor), follow the specific dosing instructions on the||
8238|049|H|packaging to find the correct dose for your age.||
8238|050|H|   If your doctor directs you to take this medication daily, take||
8238|051|H|it regularly to get the most benefit from it. To help you||
8238|052|H|remember, take it at the same time(s) each day.||
8238|053|H|   Improper use of this medication (abuse) may result in serious||
8238|054|H|harm (such as brain damage, seizure, death). Do not increase your||
8238|055|H|dose, take it more often, or use it for a longer time than||
8238|056|H|prescribed. Properly stop the medication when so directed.||
8238|057|H|   Tell your doctor if your symptoms last or get worse after more||
8238|058|H|than 1 week or if you also have fever, chills, headache, or rash.||
8238|059|H|These may be signs of a more serious condition.||
8238|060|B|||
8238|061|S|SIDE EFFECTS:  Slight drowsiness/dizziness, nausea, or vomiting||
8238|062|S|may occur. Rarely, some people may experience severe||
8238|063|S|drowsiness/dizziness with normal doses. If any of these effects||
8238|064|S|last or get worse, tell your doctor or pharmacist promptly.||
8238|065|S|   If your doctor has directed you to use this medication,||
8238|066|S|remember that your doctor has judged that the benefit to you is||
8238|067|S|greater than the risk of side effects. Many people using this||
8238|068|S|medication do not have serious side effects.||
8238|069|S|   A very serious allergic reaction to this drug is rare.||
8238|070|S|However, get medical help right away if you notice any symptoms||
8238|071|S|of a serious allergic reaction, including: rash, itching/swelling||
8238|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8238|073|S|breathing.||
8238|074|S|   This is not a complete list of possible side effects. If you||
8238|075|S|notice other effects not listed above, contact your doctor or||
8238|076|S|pharmacist.||
8238|077|S|   In the US -||
8238|078|S|   Call your doctor for medical advice about side effects. You||
8238|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8238|080|S|www.fda.gov/medwatch.||
8238|081|S|   In Canada - Call your doctor for medical advice about side||
8238|082|S|effects. You may report side effects to Health Canada at||
8238|083|S|1-866-234-2345.||
8238|084|B|||
8238|085|P|PRECAUTIONS:  Before taking dextromethorphan, tell your doctor or||
8238|086|P|pharmacist if you are allergic to it; or if you have any other||
8238|087|P|allergies. This product may contain inactive ingredients, which||
8238|088|P|can cause allergic reactions or other problems. Talk to your||
8238|089|P|pharmacist for more details.||
8238|090|P|   Before using this medication, tell your doctor or pharmacist||
8238|091|P|your medical history, especially of: lung problems (such as||
8238|092|P|asthma, emphysema).||
8238|093|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8238|094|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8238|095|P|machinery, or do anything that needs alertness until you can do||
8238|096|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
8238|097|P|are using marijuana (cannabis).||
8238|098|P|   This medicine may contain aspartame. If you have||
8238|099|P|phenylketonuria (PKU) or any other condition that requires you to||
8238|100|P|restrict your intake of aspartame (or phenylalanine), consult||
8238|101|P|your doctor or pharmacist about using this drug safely.||
8238|102|P|   During pregnancy, this medication should be used only when||
8238|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
8238|104|P|    This medication passes into breast milk. Consult your doctor||
8238|105|P|before breastfeeding.||
8238|106|B|||
8238|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8238|108|I|medications work or increase your risk for serious side effects.||
8238|109|I|This document does not contain all possible drug interactions.||
8238|110|I|Keep a list of all the products you use (including||
8238|111|I|prescription/nonprescription drugs and herbal products) and share||
8238|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
8238|113|I|the dosage of any medicines without your doctor's approval.||
8238|114|I|   Taking certain MAO inhibitors with this medication may cause a||
8238|115|I|serious (possibly fatal) drug interaction. Avoid taking||
8238|116|I|isocarboxazid, metaxalone, methylene blue, moclobemide,||
8238|117|I|phenelzine, procarbazine, rasagiline, safinamide, selegiline, or||
8238|118|I|tranylcypromine during treatment with this medication. Most MAO||
8238|119|I|inhibitors should also not be taken for two weeks before||
8238|120|I|treatment with this medication. Ask your doctor when to start or||
8238|121|I|stop taking this medication.||
8238|122|I|   Some products that may interact with this drug are: other||
8238|123|I|medications for cough (such as hydrocodone, over-the-counter||
8238|124|I|cough/cold products), rolapitant.||
8238|125|B|||
8238|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8238|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8238|128|O|poison control center right away. US residents can call||
8238|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8238|130|O|Symptoms of overdose may include: fast heartbeat, vomiting,||
8238|131|O|sweating, nervousness, feeling high (euphoria), hallucinations,||
8238|132|O|problems walking (staggering), agitation, severe drowsiness.||
8238|133|B|||
8238|134|N|NOTES:  Keep all medical and lab appointments.||
8238|135|B|||
8238|136|D|MISSED DOSE:  If you are taking this product on a regular||
8238|137|D|schedule and miss a dose, take it as soon as you remember. If it||
8238|138|D|is near the time of the next dose, skip the missed dose. Take||
8238|139|D|your next dose at the regular time. Do not double the dose to||
8238|140|D|catch up.||
8238|141|B|||
8238|142|R|STORAGE:  Store at room temperature. Keep all medications away||
8238|143|R|from children and pets.||
8238|144|R|   Do not flush medications down the toilet or pour them into a||
8238|145|R|drain unless instructed to do so. Properly discard this product||
8238|146|R|when it is expired or no longer needed. Consult your pharmacist||
8238|147|R|or local waste disposal company.||
8238|148|B|||
8238|149|A|Information last revised July 2025.||
8238|150|A|Copyright(c) 2025 First Databank, Inc.||
8238|151|B|||
8239|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8239|002|Z|does NOT have all possible information about this product. This||
8239|003|Z|information does not assure that this product is safe, effective,||
8239|004|Z|or appropriate for you. This information is not individual||
8239|005|Z|medical advice and does not substitute for the advice of your||
8239|006|Z|health care professional. Always ask your health care||
8239|007|Z|professional for complete information about this product and your||
8239|008|Z|specific health needs.||
8239|009|B|||
8239|010|T|LEVOMEPROMAZINE (METHOTRIMEPRAZINE) - ORAL||
8239|011|F|(LEE-voe-me-PROE-ma-zeen/METH-oh-trye-MEP-ra-zeen)||
8239|012|B|||
8239|013|W|WARNING:  There may be a slightly increased risk of serious,||
8239|014|W|possibly fatal side effects (such as heart failure,||
8239|015|W|fast/irregular heartbeat, pneumonia) when this medication is used||
8239|016|W|by older adults with dementia. This medication is not approved||
8239|017|W|for the treatment of dementia-related behavior problems. Discuss||
8239|018|W|the risks and benefits of this medication, as well as other||
8239|019|W|effective and possibly safer treatments for dementia-related||
8239|020|W|behavior problems, with the doctor.||
8239|021|B|||
8239|022|U|USES:  Levomepromazine (also known as methotrimeprazine) is used||
8239|023|U|to treat certain mental/mood disorders (such as schizophrenia,||
8239|024|U|bipolar disorder, anxiety). It is also used to treat a certain||
8239|025|U|sleep problem (insomnia), nausea/vomiting, and pain.||
8239|026|U|Levomepromazine belongs to a class of drugs known as||
8239|027|U|antipsychotics. It works by helping to restore the balance of||
8239|028|U|certain natural substances in the brain.||
8239|029|B|||
8239|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8239|031|H|from your pharmacist before you start taking levomepromazine and||
8239|032|H|each time you get a refill. If you have any questions, ask your||
8239|033|H|doctor or pharmacist.||
8239|034|H|   Take this medication by mouth with food as directed by your||
8239|035|H|doctor. To reduce your risk of side effects (such as drowsiness),||
8239|036|H|your doctor may direct you to start this medication at a low dose||
8239|037|H|and gradually increase your dose. Your doctor will adjust your||
8239|038|H|dose to find the best dose for you. When you first start the||
8239|039|H|medication, your doctor may direct you to divide your dose and||
8239|040|H|take the drug 2 to 3 times a day. After you have been taking the||
8239|041|H|medication for some time, your doctor may direct you to take your||
8239|042|H|medication as a single dose, usually once daily at bedtime.||
8239|043|H|Follow your doctor's directions carefully.||
8239|044|H|   The dosage is based on your medical condition, age, and||
8239|045|H|response to treatment. Children's dosage is also based on weight.||
8239|046|H|If drowsiness is a problem, your doctor may direct you to take a||
8239|047|H|lower dose during the day and a higher dose at bedtime.||
8239|048|H|   If you are using the liquid form of this medication, carefully||
8239|049|H|measure the dose using a special measuring device/spoon. Do not||
8239|050|H|use a household spoon because you may not get the correct dose.||
8239|051|H|   Take this medication regularly to get the most benefit from||
8239|052|H|it. To help you remember, take it at the same time(s) each day.||
8239|053|H|Do not stop taking this medication without consulting your||
8239|054|H|doctor. Some conditions may become worse when the drug is||
8239|055|H|suddenly stopped. Your dose may need to be gradually decreased.||
8239|056|H|   Tell your doctor if your condition does not get better or if||
8239|057|H|it gets worse.||
8239|058|B|||
8239|059|S|SIDE EFFECTS:  See also Warning section.||
8239|060|S|   Dizziness, lightheadedness, drowsiness, constipation, dry||
8239|061|S|mouth, blurred vision, difficulty urinating, and weight gain may||
8239|062|S|occur. If any of these effects last or get worse, tell your||
8239|063|S|doctor or pharmacist promptly.||
8239|064|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
8239|065|S|chips, chew (sugarless) gum, drink water, or use a saliva||
8239|066|S|substitute.||
8239|067|S|   Dizziness and lightheadedness can increase the risk of||
8239|068|S|falling. Get up slowly when rising from a sitting or lying||
8239|069|S|position. Your doctor may tell you to stay in bed for 1 to 2 days||
8239|070|S|when first starting this medication until your body gets used to||
8239|071|S|it and the dizziness lessens.||
8239|072|S|   Tell your doctor right away if any of these side effects||
8239|073|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
8239|074|S|mask-like expression of the face, drooling/trouble swallowing, or||
8239|075|S|shuffling walk. Your doctor may prescribe another medication to||
8239|076|S|decrease these side effects.||
8239|077|S|   Remember that this medication has been prescribed because your||
8239|078|S|doctor has judged that the benefit to you is greater than the||
8239|079|S|risk of side effects. Many people using this medication do not||
8239|080|S|have serious side effects.||
8239|081|S|   This medication may rarely make your blood sugar rise, which||
8239|082|S|can cause or worsen diabetes. Tell your doctor right away if you||
8239|083|S|have symptoms of high blood sugar such as increased||
8239|084|S|thirst/urination. If you already have diabetes, check your blood||
8239|085|S|sugar regularly as directed and share the results with your||
8239|086|S|doctor. Your doctor may need to adjust your diabetes medication,||
8239|087|S|exercise program, or diet.||
8239|088|S|   This medication may increase a certain natural substance||
8239|089|S|(prolactin) made by the body. For females, this increase in||
8239|090|S|prolactin may result in unwanted breast milk, missed/stopped||
8239|091|S|periods, or difficulty becoming pregnant. For males, it may||
8239|092|S|result in decreased sexual ability, inability to produce sperm,||
8239|093|S|or enlarged breasts. If you develop any of these symptoms, tell||
8239|094|S|your doctor right away.||
8239|095|S|   Rarely, males may have a painful or prolonged erection lasting||
8239|096|S|4 or more hours. If this occurs, stop using this drug and get||
8239|097|S|medical help right away, or permanent problems could occur.||
8239|098|S|   Levomepromazine may rarely cause a condition known as tardive||
8239|099|S|dyskinesia. In some cases, this condition may be permanent. Tell||
8239|100|S|your doctor right away if you develop any unusual/uncontrolled||
8239|101|S|movements (especially of the face, lips, mouth, tongue, arms, or||
8239|102|S|legs).||
8239|103|S|   This medication may rarely cause a very serious condition||
8239|104|S|called neuroleptic malignant syndrome (NMS). Get medical help||
8239|105|S|right away if you have any of the following symptoms: fever,||
8239|106|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
8239|107|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
8239|108|S|signs of kidney problems (such as change in the amount of urine).||
8239|109|S|   Tell your doctor right away if you have any serious side||
8239|110|S|effects, including: nausea/vomiting that doesn't stop, loss of||
8239|111|S|appetite, easy bleeding/bruising, signs of infection (such as||
8239|112|S|sore throat that doesn't go away, fever, chills),||
8239|113|S|stomach/abdominal pain, yellowing eyes/skin.||
8239|114|S|   Get medical help right away if you have any very serious side||
8239|115|S|effects, including: diarrhea that doesn't stop, sudden||
8239|116|S|pain/swelling/redness, fainting, severe dizziness, seizures,||
8239|117|S|blood/mucus in the stool.||
8239|118|S|   A very serious allergic reaction to this drug is rare.||
8239|119|S|However, get medical help right away if you notice any symptoms||
8239|120|S|of a serious allergic reaction, including: rash, itching/swelling||
8239|121|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8239|122|S|breathing.||
8239|123|S|   This is not a complete list of possible side effects. If you||
8239|124|S|notice other effects not listed above, contact your doctor or||
8239|125|S|pharmacist.||
8239|126|S|   In the US -||
8239|127|S|   Call your doctor for medical advice about side effects. You||
8239|128|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8239|129|S|www.fda.gov/medwatch.||
8239|130|S|   In Canada - Call your doctor for medical advice about side||
8239|131|S|effects. You may report side effects to Health Canada at||
8239|132|S|1-866-234-2345.||
8239|133|B|||
8239|134|P|PRECAUTIONS:  Before taking levomepromazine, tell your doctor or||
8239|135|P|pharmacist if you are allergic to it; or to other phenothiazines||
8239|136|P|(such as chlorpromazine); or if you have any other allergies.||
8239|137|P|This product may contain inactive ingredients, which can cause||
8239|138|P|allergic reactions or other problems. Talk to your pharmacist for||
8239|139|P|more details.||
8239|140|P|   Before using this medication, tell your doctor or pharmacist||
8239|141|P|your medical history, especially of: blood problems (such as low||
8239|142|P|white blood cell count, low platelets, anemia), brain||
8239|143|P|injury/tumor, a certain severe nervous system problem (severe CNS||
8239|144|P|depression), liver disease, a certain adrenal gland tumor||
8239|145|P|(pheochromocytoma), a certain eye problem (glaucoma), heart||
8239|146|P|problems (such as angina, heart attack, fast/irregular||
8239|147|P|heartbeat), Parkinson's disease, seizures, difficulty urinating||
8239|148|P|(such as due to prostate problems).||
8239|149|P|   Levomepromazine may cause a condition that affects the heart||
8239|150|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8239|151|P|serious (rarely fatal) fast/irregular heartbeat and other||
8239|152|P|symptoms (such as severe dizziness, fainting) that need medical||
8239|153|P|attention right away.||
8239|154|P|   The risk of QT prolongation may be increased if you have||
8239|155|P|certain medical conditions or are taking other drugs that may||
8239|156|P|cause QT prolongation. Before using levomepromazine, tell your||
8239|157|P|doctor or pharmacist of all the drugs you take and if you have||
8239|158|P|any of the following conditions: certain heart problems (heart||
8239|159|P|failure, slow heartbeat, QT prolongation in the EKG), family||
8239|160|P|history of certain heart problems (QT prolongation in the EKG,||
8239|161|P|sudden cardiac death).||
8239|162|P|   Low levels of potassium or magnesium in the blood may also||
8239|163|P|increase your risk of QT prolongation. This risk may increase if||
8239|164|P|you use certain drugs (such as diuretics/"water pills") or if you||
8239|165|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8239|166|P|Talk to your doctor about using levomepromazine safely.||
8239|167|P|   This drug may make you dizzy or drowsy or blur your vision.||
8239|168|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8239|169|P|drowsy. Do not drive, use machinery, or do anything that needs||
8239|170|P|alertness or clear vision until you can do it safely. Avoid||
8239|171|P|alcoholic beverages. Talk to your doctor if you are using||
8239|172|P|marijuana (cannabis).||
8239|173|P|   This medication may make you more sensitive to the sun. Limit||
8239|174|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8239|175|P|sunscreen and wear protective clothing when outdoors. Tell your||
8239|176|P|doctor right away if you get sunburned or have skin||
8239|177|P|blisters/redness.||
8239|178|P|   This medication may make you sweat less, making you more||
8239|179|P|likely to get heat stroke. Avoid doing things that may cause you||
8239|180|P|to overheat, such as hard work or exercise in hot weather, or||
8239|181|P|using hot tubs. When the weather is hot, drink a lot of fluids||
8239|182|P|and dress lightly. If you overheat, quickly look for a place to||
8239|183|P|cool down and rest. Get medical help right away if you have a||
8239|184|P|fever that does not go away, mental/mood changes, headache, or||
8239|185|P|dizziness.||
8239|186|P|   Before having procedures with injected dye (such as certain||
8239|187|P|X-ray procedures) or surgery, tell your doctor or dentist about||
8239|188|P|all the products you use (including prescription drugs,||
8239|189|P|nonprescription drugs, and herbal products).||
8239|190|P|   Liquid forms of this product may contain sugar and/or alcohol.||
8239|191|P|Caution is advised if you have diabetes, alcohol dependence, or||
8239|192|P|liver disease. Ask your doctor or pharmacist about using this||
8239|193|P|product safely.||
8239|194|P|   Older adults may be more sensitive to the side effects of this||
8239|195|P|drug, especially drowsiness, dizziness, lightheadedness,||
8239|196|P|difficulty urinating, severe constipation, and QT prolongation||
8239|197|P|(see above). Drowsiness, dizziness, and lightheadedness can||
8239|198|P|increase the risk of falling.||
8239|199|P|   During pregnancy, this medication should be used only when||
8239|200|P|clearly needed. Babies born to mothers who have used this drug||
8239|201|P|during the last 3 months of pregnancy may rarely develop symptoms||
8239|202|P|including muscle stiffness or shakiness, drowsiness,||
8239|203|P|feeding/breathing difficulties, or constant crying. If you notice||
8239|204|P|any of these symptoms in your newborn especially during their||
8239|205|P|first month, tell the doctor right away.||
8239|206|P|   Since untreated mental/mood problems (such as schizophrenia,||
8239|207|P|bipolar disorder) can be a serious condition, do not stop taking||
8239|208|P|this medication unless directed by your doctor. If you are||
8239|209|P|planning pregnancy, become pregnant, or think you may be||
8239|210|P|pregnant, immediately discuss with your doctor the benefits and||
8239|211|P|risks of using this medication during pregnancy.||
8239|212|P|   It is unknown if this drug passes into breast milk, but it may||
8239|213|P|have undesirable effects on a nursing infant. Consult your doctor||
8239|214|P|before breastfeeding.||
8239|215|B|||
8239|216|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8239|217|I|medications work or increase your risk for serious side effects.||
8239|218|I|This document does not contain all possible drug interactions.||
8239|219|I|Keep a list of all the products you use (including||
8239|220|I|prescription/nonprescription drugs and herbal products) and share||
8239|221|I|it with your doctor and pharmacist. Do not start, stop, or change||
8239|222|I|the dosage of any medicines without your doctor's approval.||
8239|223|I|   Many drugs besides levomepromazine may affect the heart rhythm||
8239|224|I|(QT prolongation), including dronedarone, pimozide, among others.||
8239|225|I|   Tell your doctor or pharmacist if you are taking other||
8239|226|I|products that cause drowsiness such as opioid pain or cough||
8239|227|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8239|228|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
8239|229|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
8239|230|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8239|231|I|diphenhydramine).||
8239|232|I|   Check the labels on all your medicines (such as allergy or||
8239|233|I|cough-and-cold products) because they may contain ingredients||
8239|234|I|that cause drowsiness. Ask your pharmacist about using those||
8239|235|I|products safely.||
8239|236|B|||
8239|237|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8239|238|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8239|239|O|poison control center right away. US residents can call||
8239|240|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8239|241|O|Symptoms of overdose may include: severe muscle spasms, deep||
8239|242|O|sleep, loss of consciousness, seizures.||
8239|243|B|||
8239|244|N|NOTES:  Do not share this medication with others.||
8239|245|N|   Lab and/or medical tests (such as complete blood count, liver||
8239|246|N|function, weight) should be done before you start taking this||
8239|247|N|medication and while you are taking it. Keep all medical and lab||
8239|248|N|appointments. Consult your doctor for more details.||
8239|249|B|||
8239|250|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8239|251|D|remember. If it is near the time of the next dose, skip the||
8239|252|D|missed dose. Take your next dose at the regular time. Do not||
8239|253|D|double the dose to catch up.||
8239|254|B|||
8239|255|R|STORAGE:  Store at room temperature away from light and moisture.||
8239|256|R|Do not store in the bathroom. Keep all medications away from||
8239|257|R|children and pets.||
8239|258|R|   Do not flush medications down the toilet or pour them into a||
8239|259|R|drain unless instructed to do so. Properly discard this product||
8239|260|R|when it is expired or no longer needed. Consult your pharmacist||
8239|261|R|or local waste disposal company.||
8239|262|B|||
8239|263|A|Information last revised May 2025.||
8239|264|A|Copyright(c) 2025 First Databank, Inc.||
8239|265|B|||
8241|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8241|002|Z|does NOT have all possible information about this product. This||
8241|003|Z|information does not assure that this product is safe, effective,||
8241|004|Z|or appropriate for you. This information is not individual||
8241|005|Z|medical advice and does not substitute for the advice of your||
8241|006|Z|health care professional. Always ask your health care||
8241|007|Z|professional for complete information about this product and your||
8241|008|Z|specific health needs.||
8241|009|B|||
8241|010|T|KETOPROFEN ENTERIC-COATED OR SUSTAINED-ACTION TABLET - ORAL||
8241|011|F|(KEE-toe-PROE-fen)||
8241|012|B|||
8241|013|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
8241|014|W|ketoprofen) may rarely increase the risk of a heart attack or||
8241|015|W|stroke. This effect can happen at any time while taking this drug||
8241|016|W|but is more likely if you take it for a long time. The risk may||
8241|017|W|be greater in older adults or if you have heart disease or||
8241|018|W|increased risk for heart disease (for example, due to smoking,||
8241|019|W|family history of heart disease, or conditions such as high blood||
8241|020|W|pressure or diabetes). Do not take this drug right before or||
8241|021|W|after heart bypass surgery (CABG).||
8241|022|W|   Also, this drug may rarely cause serious (rarely fatal)||
8241|023|W|bleeding from the stomach or intestines. This effect can occur||
8241|024|W|without warning symptoms at any time while taking this drug.||
8241|025|W|Older adults may be at higher risk for this effect.||
8241|026|W|   Stop taking ketoprofen and get medical help right away if you||
8241|027|W|notice any of these rare but serious side effects:||
8241|028|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
8241|029|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
8241|030|W|shortness of breath, unusual sweating, confusion, weakness on one||
8241|031|W|side of the body, trouble speaking, sudden vision changes.||
8241|032|W|   Talk to your doctor or pharmacist about the benefits and risks||
8241|033|W|of taking this drug.||
8241|034|B|||
8241|035|U|USES:  See also Warning section.||
8241|036|U|   Ketoprofen is used to relieve pain from various conditions||
8241|037|U|such as dental pain, menstrual cramps, muscle aches, and pain||
8241|038|U|after giving birth. It is also used to reduce pain, swelling, and||
8241|039|U|joint stiffness from arthritis.||
8241|040|U|   Ketoprofen is known as a nonsteroidal anti-inflammatory drug||
8241|041|U|(NSAID). It works by blocking your body's production of certain||
8241|042|U|natural substances that cause inflammation. This effect helps to||
8241|043|U|decrease swelling, pain, or fever.||
8241|044|U|   If you are treating a chronic condition such as arthritis, ask||
8241|045|U|your doctor about non-drug treatments and/or using other||
8241|046|U|medications to treat your pain.||
8241|047|B|||
8241|048|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8241|049|H|from your pharmacist before you start taking ketoprofen and each||
8241|050|H|time you get a refill. If you have any questions, ask your doctor||
8241|051|H|or pharmacist.||
8241|052|H|   Take this medication by mouth on an empty stomach, at least 1||
8241|053|H|hour before meals or 2 hours after meals as directed by your||
8241|054|H|doctor, usually 1 to 4 times daily or as needed. Take this||
8241|055|H|medication with a full glass of water (8 ounces/240 milliliters)||
8241|056|H|unless your doctor directs you otherwise. Do not lie down for at||
8241|057|H|least 10 minutes after taking this medication.||
8241|058|H|   Swallow enteric-coated tablets whole. Do not crush or chew||
8241|059|H|enteric-coated tablets. Doing so can increase stomach upset.||
8241|060|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
8241|061|H|Doing so can release all of the drug at once, increasing the risk||
8241|062|H|of side effects.||
8241|063|H|   The dosage is based on your medical condition and response to||
8241|064|H|treatment. To reduce your risk of stomach bleeding and other side||
8241|065|H|effects, take this medication at the lowest effective dose for||
8241|066|H|the shortest possible time. Do not increase your dose or use this||
8241|067|H|drug more often or for longer than prescribed. Discuss the risks||
8241|068|H|and benefits with your doctor or pharmacist.||
8241|069|H|   For certain conditions (such as arthritis), it may take up to||
8241|070|H|2 weeks of taking this drug regularly until you get the full||
8241|071|H|benefit.||
8241|072|H|   If you are taking this drug "as needed" (not on a regular||
8241|073|H|schedule), remember that pain medications work best if they are||
8241|074|H|used as the first signs of pain occur. If you wait until the pain||
8241|075|H|has worsened, the medicine may not work as well.||
8241|076|H|   Tell your doctor if your condition lasts or gets worse.||
8241|077|B|||
8241|078|S|SIDE EFFECTS:  See also Warning section.||
8241|079|S|   Upset stomach, nausea, constipation, diarrhea, gas, dizziness,||
8241|080|S|drowsiness, blurred vision, or headache may occur. If any of||
8241|081|S|these effects last or get worse, tell your doctor or pharmacist||
8241|082|S|promptly.||
8241|083|S|   Remember that this medication has been prescribed because your||
8241|084|S|doctor has judged that the benefit to you is greater than the||
8241|085|S|risk of side effects. Many people using this medication do not||
8241|086|S|have serious side effects.||
8241|087|S|   This medication may raise your blood pressure. Check your||
8241|088|S|blood pressure regularly and tell your doctor if the results are||
8241|089|S|high.||
8241|090|S|   Tell your doctor right away if you have any serious side||
8241|091|S|effects, including: hearing changes (such as ringing in the||
8241|092|S|ears), mental/mood changes, easy bleeding/bruising,||
8241|093|S|difficult/painful swallowing, signs of kidney problems (such as||
8241|094|S|change in the amount of urine, pink/bloody urine), symptoms of||
8241|095|S|heart failure (such as swelling ankles/feet, unusual tiredness,||
8241|096|S|unusual/sudden weight gain).||
8241|097|S|   Ketoprofen may rarely cause serious (possibly fatal) liver||
8241|098|S|disease. Get medical help right away if you have any symptoms of||
8241|099|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
8241|100|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
8241|101|S|urine.||
8241|102|S|   A very serious allergic reaction to this drug is rare.||
8241|103|S|However, get medical help right away if you notice any symptoms||
8241|104|S|of a serious allergic reaction, including: fever, swollen lymph||
8241|105|S|nodes, rash, itching/swelling (especially of the||
8241|106|S|face/tongue/throat), severe dizziness, trouble breathing.||
8241|107|S|   This is not a complete list of possible side effects. If you||
8241|108|S|notice other effects not listed above, contact your doctor or||
8241|109|S|pharmacist.||
8241|110|S|   In the US -||
8241|111|S|   Call your doctor for medical advice about side effects. You||
8241|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8241|113|S|www.fda.gov/medwatch.||
8241|114|S|   In Canada - Call your doctor for medical advice about side||
8241|115|S|effects. You may report side effects to Health Canada at||
8241|116|S|1-866-234-2345.||
8241|117|B|||
8241|118|P|PRECAUTIONS:  See also Warning section.||
8241|119|P|   Before taking ketoprofen, tell your doctor or pharmacist if||
8241|120|P|you are allergic to it; or to aspirin or other NSAIDs (such as||
8241|121|P|ibuprofen, naproxen, celecoxib); or if you have any other||
8241|122|P|allergies. This product may contain inactive ingredients, which||
8241|123|P|can cause allergic reactions or other problems. Talk to your||
8241|124|P|pharmacist for more details.||
8241|125|P|   Before taking this medication, tell your doctor or pharmacist||
8241|126|P|your medical history, especially of: asthma (including a history||
8241|127|P|of worsening breathing after taking aspirin or other NSAIDs),||
8241|128|P|bleeding/clotting problems, blood disorders (such as anemia),||
8241|129|P|growths in the nose (nasal polyps), heart disease (such as||
8241|130|P|previous heart attack), high blood pressure, liver disease,||
8241|131|P|stroke, swelling (edema, fluid retention),||
8241|132|P|stomach/intestinal/esophagus problems (such as bleeding,||
8241|133|P|heartburn, ulcers).||
8241|134|P|   Kidney problems can sometimes occur with the use of NSAID||
8241|135|P|medications, including ketoprofen. Problems are more likely to||
8241|136|P|occur if you are dehydrated, have heart failure or kidney||
8241|137|P|disease, are an older adult, or if you take certain medications||
8241|138|P|(see also Drug Interactions section). Drink plenty of fluids as||
8241|139|P|directed by your doctor to prevent dehydration and tell your||
8241|140|P|doctor right away if you have pink/bloody urine or any change in||
8241|141|P|the amount of urine.||
8241|142|P|   This drug may make you dizzy or drowsy or cause blurred||
8241|143|P|vision. Alcohol or marijuana (cannabis) can worsen these effects.||
8241|144|P|Do not drive, use machinery, or do anything that needs alertness||
8241|145|P|until you can do it safely. Limit alcoholic beverages. Talk to||
8241|146|P|your doctor if you are using marijuana (cannabis).||
8241|147|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
8241|148|P|and tobacco, especially when combined with this medicine, may||
8241|149|P|increase your risk for stomach bleeding. Limit alcohol and stop||
8241|150|P|smoking. Ask your doctor or pharmacist about how much alcohol you||
8241|151|P|may safely drink.||
8241|152|P|   This medication may make you more sensitive to the sun. Limit||
8241|153|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8241|154|P|sunscreen and wear protective clothing when outdoors. Tell your||
8241|155|P|doctor right away if you get sunburned or have skin||
8241|156|P|blisters/redness.||
8241|157|P|   Before having surgery, tell your doctor or dentist about all||
8241|158|P|the products you use (including prescription drugs,||
8241|159|P|nonprescription drugs, and herbal products).||
8241|160|P|   Older adults may be at greater risk for stomach/intestinal||
8241|161|P|bleeding, kidney problems, heart attack, and stroke while using||
8241|162|P|this drug.||
8241|163|P|   Before using this medication, women of childbearing age should||
8241|164|P|talk with their doctor(s) about the benefits and risks. Tell your||
8241|165|P|doctor if you are pregnant or if you plan to become pregnant.||
8241|166|P|This medication may harm an unborn baby and cause problems with||
8241|167|P|normal labor/delivery. It is not recommended for use in pregnancy||
8241|168|P|from 20 weeks until delivery. If your doctor decides that you||
8241|169|P|need to use this medication between 20 and 30 weeks of pregnancy,||
8241|170|P|you should use the lowest effective dose for the shortest||
8241|171|P|possible time. You should not use this medication after 30 weeks||
8241|172|P|of pregnancy.||
8241|173|P|   This drug passes into breast milk. Consult your doctor before||
8241|174|P|breastfeeding.||
8241|175|B|||
8241|176|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8241|177|I|medications work or increase your risk for serious side effects.||
8241|178|I|This document does not contain all possible drug interactions.||
8241|179|I|Keep a list of all the products you use (including||
8241|180|I|prescription/nonprescription drugs and herbal products) and share||
8241|181|I|it with your doctor and pharmacist. Do not start, stop, or change||
8241|182|I|the dosage of any medicines without your doctor's approval.||
8241|183|I|   Some products that may interact with this drug are: aliskiren,||
8241|184|I|ACE inhibitors (such as benazepril, lisinopril), angiotensin II||
8241|185|I|receptor blockers (such as losartan, valsartan), cidofovir,||
8241|186|I|corticosteroids (such as dexamethasone, prednisone), lithium,||
8241|187|I|methotrexate, "water pills" (diuretics such as furosemide).||
8241|188|I|   Other medications can affect the removal of ketoprofen from||
8241|189|I|your body, which may affect how ketoprofen works. An example is||
8241|190|I|probenecid, among others.||
8241|191|I|   This medication may increase the risk of bleeding when taken||
8241|192|I|with other drugs that also may cause bleeding. Examples include||
8241|193|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
8241|194|I|dabigatran/enoxaparin/warfarin, among others.||
8241|195|I|   Check all prescription and nonprescription medicine labels||
8241|196|I|carefully since many medications contain pain relievers/fever||
8241|197|I|reducers (aspirin, NSAIDs such as ibuprofen, ketorolac,||
8241|198|I|naproxen). These drugs are similar to ketoprofen and may increase||
8241|199|I|your risk of side effects if taken together. However, if your||
8241|200|I|doctor has told you to take low-dose aspirin to prevent heart||
8241|201|I|attack or stroke (usually 81-162 milligrams a day), you should||
8241|202|I|keep taking the aspirin unless your doctor tells you not to. Ask||
8241|203|I|your doctor or pharmacist for more details.||
8241|204|B|||
8241|205|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8241|206|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8241|207|O|poison control center right away. US residents can call||
8241|208|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8241|209|O|Symptoms of overdose may include: severe stomach pain,||
8241|210|O|slow/shallow breathing, extreme drowsiness, seizure.||
8241|211|B|||
8241|212|N|NOTES:  Do not share this medication with others.||
8241|213|N|   Lab and/or medical tests (such as complete blood count,||
8241|214|N|liver/kidney function, blood pressure) may be done while you are||
8241|215|N|using this medication. Keep all medical and lab appointments.||
8241|216|N|Consult your doctor for more details.||
8241|217|N|   Lifestyle changes (such as weight loss if needed,||
8241|218|N|strengthening/conditioning exercises) may help improve your||
8241|219|N|flexibility and joint function. Consult your doctor for specific||
8241|220|N|instructions.||
8241|221|B|||
8241|222|D|MISSED DOSE:  If you are taking this medication on a regular||
8241|223|D|schedule (not just "as needed") and you miss a dose, take it as||
8241|224|D|soon as you remember. If it is near the time of the next dose,||
8241|225|D|skip the missed dose. Take your next dose at the regular time. Do||
8241|226|D|not double the dose to catch up.||
8241|227|B|||
8241|228|R|STORAGE:  Store at room temperature away from light and moisture.||
8241|229|R|Do not store in the bathroom. Keep all medications away from||
8241|230|R|children and pets.||
8241|231|R|   Do not flush medications down the toilet or pour them into a||
8241|232|R|drain unless instructed to do so. Properly discard this product||
8241|233|R|when it is expired or no longer needed. Consult your pharmacist||
8241|234|R|or local waste disposal company.||
8241|235|B|||
8241|236|A|Information last revised August 2025.||
8241|237|A|Copyright(c) 2025 First Databank, Inc.||
8241|238|B|||
8245|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8245|002|Z|does NOT have all possible information about this product. This||
8245|003|Z|information does not assure that this product is safe, effective,||
8245|004|Z|or appropriate for you. This information is not individual||
8245|005|Z|medical advice and does not substitute for the advice of your||
8245|006|Z|health care professional. Always ask your health care||
8245|007|Z|professional for complete information about this product and your||
8245|008|Z|specific health needs.||
8245|009|B|||
8245|010|T|BUDESONIDE LIQUID SPRAY - NASAL||
8245|011|F|(bue-DES-oh-nide)||
8245|012|B|||
8245|013|C|COMMON BRAND NAME(S): Rhinocort Aqua||
8245|014|B|||
8245|015|U|USES:  Budesonide is used to prevent and treat seasonal and||
8245|016|U|year-round allergy symptoms (such as stuffy/runny nose, itchy||
8245|017|U|eyes/nose/throat, sneezing). Budesonide belongs to a class of||
8245|018|U|drugs known as corticosteroids. It works by reducing swelling||
8245|019|U|(inflammation) in the nasal passages.||
8245|020|B|||
8245|021|V|OTHER USES:  This section contains uses of this drug that are not||
8245|022|V|listed in the approved professional labeling for the drug but||
8245|023|V|that may be prescribed by your health care professional. Use this||
8245|024|V|drug for a condition that is listed in this section only if it||
8245|025|V|has been so prescribed by your health care professional.||
8245|026|V|   In Canada, this drug may also be used for growths in the nose||
8245|027|V|(nasal polyps).||
8245|028|B|||
8245|029|H|HOW TO USE:  If you are taking the over-the-counter product to||
8245|030|H|self-treat, read and follow all directions on the product package||
8245|031|H|before using this medication. If you have any questions, consult||
8245|032|H|your pharmacist. If your doctor has prescribed this medication,||
8245|033|H|read the Patient Information Leaflet before you start using||
8245|034|H|budesonide and each time you get a refill. If you have any||
8245|035|H|questions, ask your doctor or pharmacist.||
8245|036|H|   This medication is for use in the nose, usually 1 or 2 sprays||
8245|037|H|in each nostril once or twice a day or as directed by your||
8245|038|H|doctor. Avoid spraying this medication in your eyes. Gently blow||
8245|039|H|your nose before using this drug. Gently shake the container||
8245|040|H|before each use. Follow the instructions to properly prime the||
8245|041|H|spray pump if you are using it for the first time or if you have||
8245|042|H|not used it for 2 or more days. Follow the instructions to||
8245|043|H|clean/prime the spray pump if you have not used it for 14 or more||
8245|044|H|days.||
8245|045|H|   To use the spray, first remove the plastic cap. Close one||
8245|046|H|nostril by pressing it with your finger. Tilt your head slightly||
8245|047|H|forward and, keeping the bottle upright, carefully insert the||
8245|048|H|nasal applicator into the other nostril. Press down firmly on the||
8245|049|H|pump to deliver the prescribed number of sprays while gently||
8245|050|H|breathing in through the nose, keeping your mouth closed. Do not||
8245|051|H|spray directly onto the middle wall of your nose (nasal septum).||
8245|052|H|After spraying, remove the applicator tip and tilt your head back||
8245|053|H|for a few seconds. This will allow the medication to spread over||
8245|054|H|the back of your nose. Repeat in the other nostril. Wipe the||
8245|055|H|applicator tip and replace the plastic cap. Avoid blowing your||
8245|056|H|nose for 15 minutes after using this medication.||
8245|057|H|   The dosage is based on your age, medical condition and||
8245|058|H|response to treatment. Younger children may need a smaller dose||
8245|059|H|and help from an adult to use this medication properly. Use this||
8245|060|H|medication regularly in order to get the most benefit from it. To||
8245|061|H|help you remember, use it at the same time(s) each day. Do not||
8245|062|H|increase your dose or use this drug more often or for longer than||
8245|063|H|directed. Your condition will not improve any faster, and your||
8245|064|H|risk of side effects will increase.||
8245|065|H|   This medication does not work right away. Some people will||
8245|066|H|feel this medication working within 1 to 2 days, but it may take||
8245|067|H|up to 2 weeks before the full benefit of this drug takes effect.||
8245|068|H|Ask your doctor or pharmacist if you should also use other||
8245|069|H|medications (such as nose drops/spray, allergy drugs taken by||
8245|070|H|mouth) along with this drug until it takes full effect. Talk to||
8245|071|H|you child's doctor if your child needs to use this medication||
8245|072|H|more than 2 months a year.||
8245|073|H|   Keep track of the number of sprays used from the bottle.||
8245|074|H|Discard the bottle after you have used the number of sprays||
8245|075|H|specified on the manufacturer's package. Do not pour any||
8245|076|H|remaining medication into another container. Follow the package||
8245|077|H|instructions to unblock the spray tip if needed and to clean the||
8245|078|H|spray bottle.||
8245|079|H|   Tell your doctor if your condition does not get better after 2||
8245|080|H|weeks or if it gets worse. If you think you may have a serious||
8245|081|H|medical problem, get medical help right away.||
8245|082|B|||
8245|083|S|SIDE EFFECTS:  Nose/throat dryness or irritation, cough,||
8245|084|S|sneezing, nosebleeds, or unpleasant taste/smell may occur. If any||
8245|085|S|of these side effects last or get worse, tell your doctor or||
8245|086|S|pharmacist promptly.||
8245|087|S|   If your doctor has directed you to use this medication,||
8245|088|S|remember that your doctor has judged that the benefit to you is||
8245|089|S|greater than the risk of side effects. Many people using this||
8245|090|S|medication do not have serious side effects.||
8245|091|S|   Tell your doctor right away if you have any serious side||
8245|092|S|effects, including: loss of taste or smell, pain/sores in your||
8245|093|S|nose.||
8245|094|S|   Rarely, it is possible that corticosteroids given in the nose||
8245|095|S|will be absorbed into the bloodstream. This can lead to side||
8245|096|S|effects of too much corticosteroid. These side effects are more||
8245|097|S|likely in children and people who use this medication for a long||
8245|098|S|time and in high doses. Tell your doctor right away if any of the||
8245|099|S|following side effects occur: unusual/extreme tiredness, weight||
8245|100|S|loss, headache, swelling ankles/feet, increased thirst/urination,||
8245|101|S|vision problems.||
8245|102|S|   Corticosteroids may weaken the body's ability to fight||
8245|103|S|infections. This may make you more likely to get a serious||
8245|104|S|(rarely fatal) infection or make any infection you have worse.||
8245|105|S|This effect might also rarely occur with corticosteroids inhaled||
8245|106|S|through the nose (such as budesonide). The risk may be increased||
8245|107|S|if high doses are used, especially when used for a long time.||
8245|108|S|Tell your doctor right away if you have any signs of infection||
8245|109|S|(such as sore throat that doesn't go away, ear pain, fever,||
8245|110|S|chills, white patches inside the nose or on the back of the||
8245|111|S|throat).||
8245|112|S|   A very serious allergic reaction to this drug is rare.||
8245|113|S|However, get medical help right away if you notice any symptoms||
8245|114|S|of a serious allergic reaction, including: rash, itching/swelling||
8245|115|S|(especially of the face/tongue/throat), severe dizziness,||
8245|116|S|wheezing/trouble breathing.||
8245|117|S|   This is not a complete list of possible side effects. If you||
8245|118|S|notice other effects not listed above, contact your doctor or||
8245|119|S|pharmacist.||
8245|120|S|   In the US -||
8245|121|S|   Call your doctor for medical advice about side effects. You||
8245|122|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8245|123|S|www.fda.gov/medwatch.||
8245|124|S|   In Canada - Call your doctor for medical advice about side||
8245|125|S|effects. You may report side effects to Health Canada at||
8245|126|S|1-866-234-2345.||
8245|127|B|||
8245|128|P|PRECAUTIONS:  Before using nasal budesonide, tell your doctor or||
8245|129|P|pharmacist if you are allergic to it; or if you have any other||
8245|130|P|allergies. This product may contain inactive ingredients, which||
8245|131|P|can cause allergic reactions or other problems. Talk to your||
8245|132|P|pharmacist for more details.||
8245|133|P|   Before using this medication, tell your doctor or pharmacist||
8245|134|P|your medical history, especially of: eye problems (such as||
8245|135|P|glaucoma, cataracts), infections (including tuberculosis), recent||
8245|136|P|nose problems (such as injury, ulcers, surgery).||
8245|137|P|   Stay away from anyone who has an infection that may easily||
8245|138|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
8245|139|P|doctor if you have been exposed to an infection or for more||
8245|140|P|details.||
8245|141|P|   Rarely, using corticosteroid medications for a long time can||
8245|142|P|make it more difficult for your body to respond to physical||
8245|143|P|stress. Before having surgery or emergency treatment, or if you||
8245|144|P|get a serious illness/injury, tell your doctor or dentist that||
8245|145|P|you are using this medication or have used this medication within||
8245|146|P|the past few months.||
8245|147|P|   Before having surgery, tell your doctor or dentist about all||
8245|148|P|the products you use (including prescription drugs,||
8245|149|P|nonprescription drugs, and herbal products).||
8245|150|P|   Though it is unlikely, this medication may temporarily slow||
8245|151|P|down a child's growth if used for a long time. See the doctor||
8245|152|P|regularly so your child's height can be checked.||
8245|153|P|   Tell your doctor if you are pregnant before using nasal||
8245|154|P|budesonide. Rarely, infants born to mothers who have been using||
8245|155|P|corticosteroids (including budesonide) for a long time may have||
8245|156|P|low levels of corticosteroid hormone. Tell your doctor right away||
8245|157|P|if you notice symptoms such as nausea/vomiting that doesn't stop,||
8245|158|P|severe diarrhea, or weakness in your newborn. Discuss the risks||
8245|159|P|and benefits with your doctor.||
8245|160|P|   It is unknown if nasal budesonide passes into breast milk.||
8245|161|P|However, similar drugs pass into breast milk. Nasal budesonide||
8245|162|P|might also pass into breast milk in very small amounts that are||
8245|163|P|unlikely to harm a nursing infant. Consult your doctor before||
8245|164|P|breastfeeding.||
8245|165|B|||
8245|166|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8245|167|I|medications work or increase your risk for serious side effects.||
8245|168|I|This document does not contain all possible drug interactions.||
8245|169|I|Keep a list of all the products you use (including||
8245|170|I|prescription/nonprescription drugs and herbal products) and share||
8245|171|I|it with your doctor and pharmacist. Do not start, stop, or change||
8245|172|I|the dosage of any medicines without your doctor's approval.||
8245|173|I|   Check all prescription medicine labels carefully since similar||
8245|174|I|medications (other corticosteroids such as prednisone) may||
8245|175|I|increase your risk of side effects if taken together with this||
8245|176|I|drug. Ask your doctor or pharmacist if you have any questions||
8245|177|I|about your medications.||
8245|178|B|||
8245|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8245|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8245|181|O|poison control center right away. US residents can call||
8245|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8245|183|B|||
8245|184|N|NOTES:  Keep all medical and lab appointments.||
8245|185|N|   If you use this medication for a long time, lab and/or medical||
8245|186|N|tests (such as nose exams, height measurement in children) may be||
8245|187|N|done while you are using this medication. Keep all medical and||
8245|188|N|lab appointments. Consult your doctor for more details.||
8245|189|N|   Avoid substances (such as pollen, pet dander, dust mites,||
8245|190|N|mold, and smoke) that can worsen allergy symptoms.||
8245|191|B|||
8245|192|D|MISSED DOSE:  If you are using this product on a regular schedule||
8245|193|D|and miss a dose, use it as soon as you remember. If it is near||
8245|194|D|the time of the next dose, skip the missed dose. Use your next||
8245|195|D|dose at the regular time. Do not double the dose to catch up.||
8245|196|B|||
8245|197|R|STORAGE:  Store at room temperature with the protective cap in||
8245|198|R|place away from light and moisture. Keep container upright. Keep||
8245|199|R|all medications away from children and pets.||
8245|200|R|   Do not flush medications down the toilet or pour them into a||
8245|201|R|drain unless instructed to do so. Properly discard this product||
8245|202|R|when it is expired or no longer needed. Consult your pharmacist||
8245|203|R|or local waste disposal company.||
8245|204|B|||
8245|205|A|Information last revised February 2025.||
8245|206|A|Copyright(c) 2025 First Databank, Inc.||
8245|207|B|||
8246|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8246|002|Z|does NOT have all possible information about this product. This||
8246|003|Z|information does not assure that this product is safe, effective,||
8246|004|Z|or appropriate for you. This information is not individual||
8246|005|Z|medical advice and does not substitute for the advice of your||
8246|006|Z|health care professional. Always ask your health care||
8246|007|Z|professional for complete information about this product and your||
8246|008|Z|specific health needs.||
8246|009|B|||
8246|010|T|FACTOR IX, HUMAN - INJECTION||
8246|011|F|(FACK-ter nine)||
8246|012|B|||
8246|013|C|COMMON BRAND NAME(S): Alphanine SD, Konyne, Proplex T||
8246|014|B|||
8246|015|U|USES:  This medication is used to prevent or control bleeding in||
8246|016|U|people with little or no factor IX (due to hemophilia B,||
8246|017|U|Christmas disease). Factor IX is a protein (clotting factor) in||
8246|018|U|the blood that works with other clotting factors to help the||
8246|019|U|blood clot and stop bleeding. People with little or no factor IX||
8246|020|U|are at risk for bleeding longer after an injury/surgery or||
8246|021|U|bleeding suddenly (often in the joints/muscle) without an obvious||
8246|022|U|cause.||
8246|023|U|   This medication should not be used to reverse the effects of||
8246|024|U|"blood thinners" (such as warfarin). Most types of this||
8246|025|U|medication should not be used to treat other types of factor||
8246|026|U|deficiencies (such as factors II, VII, VIII, X) or factor||
8246|027|U|problems (such as inhibitor to factor XIII). If you are using||
8246|028|U|this medication for one of these conditions, consult your doctor||
8246|029|U|or pharmacist to make sure that you are using the right product.||
8246|030|B|||
8246|031|H|HOW TO USE:  This medication is given by injection into a vein as||
8246|032|H|directed by your doctor. The dosage is based on your medical||
8246|033|H|condition, weight, and response to treatment.||
8246|034|H|   Gently swirl the medication to mix. Do not shake. Some forms||
8246|035|H|of this medication must be completely mixed into the liquid so||
8246|036|H|that the liquid contains no particles. In these cases, do not use||
8246|037|H|the liquid if it contains particles. Other forms of this||
8246|038|H|medication may occasionally contain a few small particles in the||
8246|039|H|vial, even if the medication is mixed correctly. In these cases,||
8246|040|H|the particles will not affect how well the medication works and||
8246|041|H|will be removed by the filter. If you have questions about||
8246|042|H|whether your form of this medication may be used if it contains||
8246|043|H|particles, or if you have other questions about the use of this||
8246|044|H|medication, consult the doctor or pharmacist.||
8246|045|H|   If you are giving this medication to yourself at home, learn||
8246|046|H|all preparation and usage instructions from your health care||
8246|047|H|professional. Learn how to store and discard medical supplies||
8246|048|H|safely.||
8246|049|H|   The medication in the vial and the supplies that come with the||
8246|050|H|medication should be used only once. Do not reuse.||
8246|051|H|   Tell your doctor if your condition lasts or gets worse.||
8246|052|B|||
8246|053|S|SIDE EFFECTS:  Pain at injection site, chills, tingling,||
8246|054|S|flushing, headache, nausea, or vomiting may occur. If any of||
8246|055|S|these effects last or get worse, tell your doctor or pharmacist||
8246|056|S|promptly.||
8246|057|S|   Remember that this medication has been prescribed because your||
8246|058|S|doctor has judged that the benefit to you is greater than the||
8246|059|S|risk of side effects. Many people using this medication do not||
8246|060|S|have serious side effects.||
8246|061|S|   Tell your doctor right away if you have any serious side||
8246|062|S|effects, including: swelling at injection site, fast heartbeat,||
8246|063|S|shortness of breath, signs of kidney problems (such as change in||
8246|064|S|the amount of urine), swelling of the ankles/feet,||
8246|065|S|pain/redness/swelling of arms or legs, new or increased||
8246|066|S|bleeding/bruising.||
8246|067|S|   Get medical help right away if you have any very serious side||
8246|068|S|effects, including: chest pain, trouble breathing, bluish||
8246|069|S|fingers.||
8246|070|S|   A very serious allergic reaction to this drug is rare.||
8246|071|S|However, get medical help right away if you notice any symptoms||
8246|072|S|of a serious allergic reaction, including: rash, itching/swelling||
8246|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8246|074|S|breathing.||
8246|075|S|   This is not a complete list of possible side effects. If you||
8246|076|S|notice other effects not listed above, contact your doctor or||
8246|077|S|pharmacist.||
8246|078|S|   In the US -||
8246|079|S|   Call your doctor for medical advice about side effects. You||
8246|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8246|081|S|www.fda.gov/medwatch.||
8246|082|S|   In Canada - Call your doctor for medical advice about side||
8246|083|S|effects. You may report side effects to Health Canada at||
8246|084|S|1-866-234-2345.||
8246|085|B|||
8246|086|P|PRECAUTIONS:  Before using factor IX, tell your doctor or||
8246|087|P|pharmacist if you are allergic to factor IX products; or if you||
8246|088|P|have any other allergies. This product may contain inactive||
8246|089|P|ingredients, which can cause allergic reactions or other||
8246|090|P|problems. Talk to your pharmacist for more details.||
8246|091|P|   Before using this medication, tell your doctor or pharmacist||
8246|092|P|your medical history, especially of: other clotting disorders||
8246|093|P|(such as disseminated intravascular coagulation-DIC), heart||
8246|094|P|disease (such as coronary artery disease), immune system||
8246|095|P|problems, recent surgery/procedure, liver disease.||
8246|096|P|   Before having surgery, tell your doctor or dentist about all||
8246|097|P|the products you use (including prescription drugs,||
8246|098|P|nonprescription drugs, and herbal products).||
8246|099|P|   This medication is made from human blood. Even though the||
8246|100|P|blood is carefully tested, and this medication goes through a||
8246|101|P|special manufacturing process, there is an extremely small chance||
8246|102|P|that you may get infections from the medication (for example,||
8246|103|P|viruses such as hepatitis). Consult your doctor or pharmacist for||
8246|104|P|more information.||
8246|105|P|   During pregnancy, this medication should be used only when||
8246|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
8246|107|P|   It is unknown if this medication passes into breast milk.||
8246|108|P|Consult your doctor before breastfeeding.||
8246|109|B|||
8246|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8246|111|I|medications work or increase your risk for serious side effects.||
8246|112|I|This document does not contain all possible drug interactions.||
8246|113|I|Keep a list of all the products you use (including||
8246|114|I|prescription/nonprescription drugs and herbal products) and share||
8246|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
8246|116|I|the dosage of any medicines without your doctor's approval.||
8246|117|I|   Some products that may interact with this drug include: drugs||
8246|118|I|that help with clotting (such as aminocaproic acid, tranexamic||
8246|119|I|acid).||
8246|120|B|||
8246|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8246|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8246|123|O|poison control center right away. US residents can call||
8246|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8246|125|B|||
8246|126|N|NOTES:  Do not share this medication with others.||
8246|127|N|   Lab and/or medical tests (such as factor IX activity) should||
8246|128|N|be done while you are using this medication. Keep all medical and||
8246|129|N|lab appointments. Consult your doctor for more details.||
8246|130|B|||
8246|131|D|MISSED DOSE:  It is important to get each dose of this medication||
8246|132|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8246|133|D|right away for a new dosing schedule. Do not double the dose to||
8246|134|D|catch up.||
8246|135|B|||
8246|136|R|STORAGE:  Consult the product instructions and your pharmacist||
8246|137|R|for storage details. Keep all medications away from children and||
8246|138|R|pets.||
8246|139|R|   Do not flush medications down the toilet or pour them into a||
8246|140|R|drain unless instructed to do so. Properly discard this product||
8246|141|R|when it is expired or no longer needed. Consult your pharmacist||
8246|142|R|or local waste disposal company.||
8246|143|B|||
8246|144|M|MEDICAL ALERT:  Your condition can cause complications in a||
8246|145|M|medical emergency. For information about enrolling in MedicAlert,||
8246|146|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8246|147|B|||
8246|148|A|Information last revised November 2025.||
8246|149|A|Copyright(c) 2025 First Databank, Inc.||
8246|150|B|||
8249|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8249|002|Z|does NOT have all possible information about this product. This||
8249|003|Z|information does not assure that this product is safe, effective,||
8249|004|Z|or appropriate for you. This information is not individual||
8249|005|Z|medical advice and does not substitute for the advice of your||
8249|006|Z|health care professional. Always ask your health care||
8249|007|Z|professional for complete information about this product and your||
8249|008|Z|specific health needs.||
8249|009|B|||
8249|010|T|IRON/VITAMIN C - ORAL||
8249|011|F|(EYE-urn/VYE-ta-min C)||
8249|012|B|||
8249|013|C|COMMON BRAND NAME(S): Hematogen, Vitron-C||
8249|014|B|||
8249|015|W|WARNING:  Accidental overdose of iron-containing products is a||
8249|016|W|leading cause of fatal poisoning in children under 6 years of||
8249|017|W|age. Keep this product out of reach of children. If overdose does||
8249|018|W|occur, get medical help right away or call a poison control||
8249|019|W|center.||
8249|020|B|||
8249|021|U|USES:  This medication is an iron supplement used to treat or||
8249|022|U|prevent low blood levels of iron (such as those caused by anemia||
8249|023|U|or during pregnancy). Ascorbic acid (vitamin C) improves the||
8249|024|U|absorption of iron from the stomach.||
8249|025|B|||
8249|026|H|HOW TO USE:  Take this medication by mouth, usually once daily or||
8249|027|H|as directed by your doctor.||
8249|028|H|   This medication is best taken on an empty stomach 1 hour||
8249|029|H|before or 2 hours after meals. If stomach upset occurs, you may||
8249|030|H|take this medication with food. Avoid taking antacids, dairy||
8249|031|H|products, tea, or coffee within 2 hours before or after this||
8249|032|H|medication because they will decrease its effectiveness.||
8249|033|H|   Take with a full glass of water (8 ounces or 240 milliliters)||
8249|034|H|unless your doctor directs you otherwise. Do not lie down for at||
8249|035|H|least 10 minutes after taking this medication.||
8249|036|H|   If you are taking chewable tablets, chew the medication||
8249|037|H|thoroughly, then swallow.||
8249|038|H|   If you are taking a liquid form of this medication, carefully||
8249|039|H|measure the dose using a special measuring device/spoon. Do not||
8249|040|H|use a household spoon because you may not get the correct dose.||
8249|041|H|Mix your dose in a glass of water or juice, and drink the mixture||
8249|042|H|through a straw to prevent staining the teeth. If your liquid||
8249|043|H|form is to be given by dropper, the dose may be placed well back||
8249|044|H|on the tongue and followed with water or juice. If your liquid||
8249|045|H|form is a suspension, shake the bottle well before each dose.||
8249|046|H|   Use this medication regularly in order to get the most benefit||
8249|047|H|from it. To help you remember, take it at the same time each day.||
8249|048|B|||
8249|049|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
8249|050|S|occur. These effects are usually temporary and may disappear as||
8249|051|S|your body adjusts to this medication. If any of these effects||
8249|052|S|last or get worse, tell your doctor or pharmacist promptly.||
8249|053|S|   Iron may cause your stools to turn black, which is not||
8249|054|S|harmful.||
8249|055|S|   If your doctor has prescribed this medication, remember that||
8249|056|S|your doctor has judged that the benefit to you is greater than||
8249|057|S|the risk of side effects. Many people using this medication do||
8249|058|S|not have serious side effects.||
8249|059|S|   A very serious allergic reaction to this drug is rare.||
8249|060|S|However, get medical help right away if you notice any symptoms||
8249|061|S|of a serious allergic reaction, including: rash, itching/swelling||
8249|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8249|063|S|breathing.||
8249|064|S|   This is not a complete list of possible side effects. If you||
8249|065|S|notice other effects not listed above, contact your doctor or||
8249|066|S|pharmacist.||
8249|067|S|   In the US -||
8249|068|S|   Call your doctor for medical advice about side effects. You||
8249|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8249|070|S|www.fda.gov/medwatch.||
8249|071|S|   In Canada - Call your doctor for medical advice about side||
8249|072|S|effects. You may report side effects to Health Canada at||
8249|073|S|1-866-234-2345.||
8249|074|B|||
8249|075|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
8249|076|P|pharmacist if you are allergic to it; or if you have any other||
8249|077|P|allergies. This product may contain inactive ingredients, which||
8249|078|P|can cause allergic reactions or other problems. Talk to your||
8249|079|P|pharmacist for more details.||
8249|080|P|   Before taking this medication, tell your doctor or pharmacist||
8249|081|P|your medical history, especially of: certain metabolic disorders||
8249|082|P|(such as hemochromatosis, hemosiderosis), use/abuse of alcohol,||
8249|083|P|stomach/intestinal problems (such as ulcers, colitis).||
8249|084|P|   If your particular brand of iron supplement also contains||
8249|085|P|folic acid, be sure to tell your doctor or pharmacist if you have||
8249|086|P|vitamin B12 deficiency (pernicious anemia) before taking it.||
8249|087|P|   Before having surgery, tell your doctor or dentist about all||
8249|088|P|the products you use (including prescription drugs,||
8249|089|P|nonprescription drugs, and herbal products).||
8249|090|P|   During pregnancy, this medication should be used only when||
8249|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
8249|092|P|   This medication passes into breast milk. Consult your doctor||
8249|093|P|before breastfeeding.||
8249|094|B|||
8249|095|I|DRUG INTERACTIONS:  See also How To Use section.||
8249|096|I|   Drug interactions may change how your medications work or||
8249|097|I|increase your risk for serious side effects. This document does||
8249|098|I|not contain all possible drug interactions. Keep a list of all||
8249|099|I|the products you use (including prescription/nonprescription||
8249|100|I|drugs and herbal products) and share it with your doctor and||
8249|101|I|pharmacist. Do not start, stop, or change the dosage of any||
8249|102|I|medicines without your doctor's approval.||
8249|103|I|   This product can decrease the absorption of certain drugs,||
8249|104|I|especially if you take them around the same time. These drugs||
8249|105|I|include bisphosphonates (such as alendronate), levodopa,||
8249|106|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
8249|107|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
8249|108|I|minocycline), thyroid medications (such as levothyroxine), among||
8249|109|I|others. Ask your doctor or pharmacist how long you should wait||
8249|110|I|between doses of this product and your other medications and to||
8249|111|I|find a dosing schedule that works for all your medications.||
8249|112|I|   This medication may interfere with certain lab tests (such as||
8249|113|I|tests for blood in the stools), possibly causing false test||
8249|114|I|results. Make sure lab personnel and all your doctors know you||
8249|115|I|use this drug.||
8249|116|B|||
8249|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8249|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8249|119|O|poison control center right away. US residents can call||
8249|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8249|121|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
8249|122|O|diarrhea.||
8249|123|B|||
8249|124|N|NOTES:  Do not share this medication with others.||
8249|125|N|   Lab and/or medical tests (such as complete blood count) may be||
8249|126|N|done while you are taking this product. Keep all medical and lab||
8249|127|N|appointments. Consult your doctor for more details.||
8249|128|N|   There are many iron supplement products available. Some can be||
8249|129|N|purchased without a prescription. Some brands may also contain||
8249|130|N|other ingredients (such as folic acid, niacin). Consult your||
8249|131|N|doctor or pharmacist for more details.||
8249|132|N|   This medication is not a substitute for a proper diet. It is||
8249|133|N|important to maintain a well-balanced diet. Foods rich in iron||
8249|134|N|include beans, nuts, asparagus, oatmeal, red meat, dried peaches,||
8249|135|N|and pork liver.||
8249|136|B|||
8249|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8249|138|D|remember. If it is near the time of the next dose, skip the||
8249|139|D|missed dose. Take your next dose at the regular time. Do not||
8249|140|D|double the dose to catch up.||
8249|141|B|||
8249|142|R|STORAGE:  Different brands of this medication have different||
8249|143|R|storage needs. Check the product package for instructions on how||
8249|144|R|to store your brand, or ask your pharmacist. Keep all medications||
8249|145|R|away from children and pets.||
8249|146|R|   Do not flush medications down the toilet or pour them into a||
8249|147|R|drain unless instructed to do so. Properly discard this product||
8249|148|R|when it is expired or no longer needed. Consult your pharmacist||
8249|149|R|or local waste disposal company.||
8249|150|B|||
8249|151|A|Information last revised October 2025.||
8249|152|A|Copyright(c) 2025 First Databank, Inc.||
8249|153|B|||
8257|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8257|002|Z|does NOT have all possible information about this product. This||
8257|003|Z|information does not assure that this product is safe, effective,||
8257|004|Z|or appropriate for you. This information is not individual||
8257|005|Z|medical advice and does not substitute for the advice of your||
8257|006|Z|health care professional. Always ask your health care||
8257|007|Z|professional for complete information about this product and your||
8257|008|Z|specific health needs.||
8257|009|B|||
8257|010|T|CAFFEINE CITRATE SOLUTION - ORAL||
8257|011|F|(KAF-een SIT-rate)||
8257|012|B|||
8257|013|C|COMMON BRAND NAME(S): Cafcit||
8257|014|B|||
8257|015|U|USES:  This medication is used for the short-term treatment of a||
8257|016|U|breathing problem (apnea) in premature infants. Caffeine blocks||
8257|017|U|certain proteins (adenosine receptors) which lead to improved||
8257|018|U|breathing in these infants.||
8257|019|B|||
8257|020|V|OTHER USES:  This section contains uses of this drug that are not||
8257|021|V|listed in the approved professional labeling for the drug but||
8257|022|V|that may be prescribed by your health care professional. Use this||
8257|023|V|drug for a condition that is listed in this section only if it||
8257|024|V|has been so prescribed by your health care professional.||
8257|025|V|   This medication is also a stimulant that may be used to keep||
8257|026|V|you awake and alert.||
8257|027|B|||
8257|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8257|029|H|from your pharmacist before you start giving this drug and each||
8257|030|H|time you get a refill. If you have any questions, ask your doctor||
8257|031|H|or pharmacist.||
8257|032|H|   This medication is given by mouth or through a feeding tube||
8257|033|H|with or without formula as directed by the doctor, usually once||
8257|034|H|daily. The dosage is based on your infant's weight, medical||
8257|035|H|conditions, and response to treatment. Carefully measure each||
8257|036|H|dose with the provided dosing syringe.||
8257|037|H|   Before using, check this product for particles or||
8257|038|H|discoloration. If either is present, do not use the liquid.||
8257|039|H|   Because this product does not contain preservatives, discard||
8257|040|H|any unused medicine after preparing the dose for your infant.||
8257|041|H|   Use this medication regularly in order to get the most benefit||
8257|042|H|from it. Remember to use it at the same time each day.||
8257|043|H|   If your infant's condition lasts or gets worse, tell your||
8257|044|H|doctor or pharmacist.||
8257|045|B|||
8257|046|S|SIDE EFFECTS:  Nausea, vomiting, stomach upset, headache, trouble||
8257|047|S|sleeping, restlessness, poor feeding, increased urination, rash||
8257|048|S|or dry skin may occur. If any of these effects last or get worse,||
8257|049|S|tell your doctor or pharmacist promptly.||
8257|050|S|   Remember that this medication has been prescribed because your||
8257|051|S|doctor has judged that the benefit to you is greater than the||
8257|052|S|risk of side effects. Many people using this medication do not||
8257|053|S|have serious side effects.||
8257|054|S|   Tell your doctor right away if you have any serious side||
8257|055|S|effects, including: vision changes.||
8257|056|S|   In rare (sometimes, fatal) cases, this medication has been||
8257|057|S|associated with a serious stomach condition (necrotizing||
8257|058|S|enterocolitis). Tell your doctor right away if your infant||
8257|059|S|experiences the following: lack of energy (lethargy), severe||
8257|060|S|vomiting, stomach/abdominal bloating (distension), bloody stool.||
8257|061|S|   A very serious allergic reaction to this drug is rare.||
8257|062|S|However, get medical help right away if you notice any symptoms||
8257|063|S|of a serious allergic reaction, including: rash, itching/swelling||
8257|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8257|065|S|breathing.||
8257|066|S|   This is not a complete list of possible side effects. If you||
8257|067|S|notice other effects not listed above, contact your doctor or||
8257|068|S|pharmacist.||
8257|069|S|   In the US -||
8257|070|S|   Call your doctor for medical advice about side effects. You||
8257|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8257|072|S|www.fda.gov/medwatch.||
8257|073|S|   In Canada - Call your doctor for medical advice about side||
8257|074|S|effects. You may report side effects to Health Canada at||
8257|075|S|1-866-234-2345.||
8257|076|B|||
8257|077|P|PRECAUTIONS:  Before taking caffeine citrate, tell your doctor or||
8257|078|P|pharmacist if your infant is allergic to it; or if your infant||
8257|079|P|has any other allergies. This product may contain inactive||
8257|080|P|ingredients, which can cause allergic reactions or other||
8257|081|P|problems. Talk to your pharmacist for more details.||
8257|082|P|   Before using this medication, tell your doctor or pharmacist||
8257|083|P|your infant's medical history, especially of: heart disease,||
8257|084|P|kidney disease, liver disease, stomach problems (such as peptic||
8257|085|P|ulcers, necrotizing enterocolitis), seizures.||
8257|086|P|   Infants may be more sensitive to the side effects of this||
8257|087|P|drug, especially the stimulant effects (such as trouble sleeping,||
8257|088|P|restlessness, nervousness).||
8257|089|P|   Older adults may be more sensitive to the side effects of this||
8257|090|P|drug, especially trouble sleeping.||
8257|091|P|   During pregnancy, this medication should be used only when||
8257|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
8257|093|P|   This medication passes into breast milk and may have||
8257|094|P|undesirable effects on a nursing infant. Consult your doctor||
8257|095|P|before breastfeeding.||
8257|096|B|||
8257|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8257|098|I|medications work or increase your risk for serious side effects.||
8257|099|I|This document does not contain all possible drug interactions.||
8257|100|I|Keep a list of all the products you use (including||
8257|101|I|prescription/nonprescription drugs and herbal products) and share||
8257|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
8257|103|I|the dosage of any medicines without your doctor's approval.||
8257|104|I|   Some products that may interact with this drug are: adenosine,||
8257|105|I|cimetidine, dipyridamole, fluvoxamine, lithium, theophylline,||
8257|106|I|vemurafenib.||
8257|107|B|||
8257|108|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8257|109|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8257|110|O|poison control center right away. US residents can call||
8257|111|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8257|112|O|Symptoms of overdose may include stomach pain, anxiety,||
8257|113|O|agitation, confusion, irregular or fast heartbeat, frequent||
8257|114|O|urination, muscle twitching, ringing in the ears, trouble||
8257|115|O|sleeping, and seizures.||
8257|116|B|||
8257|117|N|NOTES:  Do not share this medication with others.||
8257|118|N|   Lab and/or medical tests (such as caffeine levels, blood||
8257|119|N|sugars) should be done while your infant is taking this||
8257|120|N|medication. Keep all medical and lab appointments. Consult your||
8257|121|N|doctor for more details.||
8257|122|B|||
8257|123|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8257|124|D|If it is near the time of the next dose, skip the missed dose.||
8257|125|D|Use your next dose at the regular time. Do not double the dose to||
8257|126|D|catch up.||
8257|127|B|||
8257|128|R|STORAGE:  Store at room temperature. Keep all medications away||
8257|129|R|from children and pets.||
8257|130|R|   Do not flush medications down the toilet or pour them into a||
8257|131|R|drain unless instructed to do so. Properly discard this product||
8257|132|R|when it is expired or no longer needed. Consult your pharmacist||
8257|133|R|or local waste disposal company.||
8257|134|B|||
8257|135|A|Information last revised November 2024.||
8257|136|A|Copyright(c) 2025 First Databank, Inc.||
8257|137|B|||
8262|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8262|002|Z|does NOT have all possible information about this product. This||
8262|003|Z|information does not assure that this product is safe, effective,||
8262|004|Z|or appropriate for you. This information is not individual||
8262|005|Z|medical advice and does not substitute for the advice of your||
8262|006|Z|health care professional. Always ask your health care||
8262|007|Z|professional for complete information about this product and your||
8262|008|Z|specific health needs.||
8262|009|B|||
8262|010|T|TERBINAFINE - ORAL||
8262|011|F|(ter-BIN-uh-feen)||
8262|012|B|||
8262|013|C|COMMON BRAND NAME(S): Lamisil||
8262|014|B|||
8262|015|U|USES:  Terbinafine is used to treat certain types of fungal||
8262|016|U|infections (for example, of the fingernail or toenail). It works||
8262|017|U|by stopping the growth of fungus. This medication belongs to a||
8262|018|U|class of drugs known as antifungals.||
8262|019|B|||
8262|020|H|HOW TO USE:  Read the Medication Guide provided by your||
8262|021|H|pharmacist before you start taking terbinafine and each time you||
8262|022|H|get a refill. If you have any questions, ask your doctor or||
8262|023|H|pharmacist.||
8262|024|H|   Take this medication by mouth with or without food as directed||
8262|025|H|by your doctor, usually once a day. The dosage and length of||
8262|026|H|treatment is based on your medical condition and response to||
8262|027|H|treatment.||
8262|028|H|   It may take several months after you finish treatment to see||
8262|029|H|the full benefit of this drug. It takes time for your new healthy||
8262|030|H|nails to grow out and replace the infected nails.||
8262|031|H|   Continue to take this medication until the full prescribed||
8262|032|H|amount is finished, even if symptoms disappear after a few days.||
8262|033|H|Stopping the medication too early may result in a return of the||
8262|034|H|infection.||
8262|035|H|   Tell your doctor if your condition lasts or gets worse.||
8262|036|B|||
8262|037|S|SIDE EFFECTS:  Diarrhea or stomach upset may occur. If either of||
8262|038|S|these effects lasts or gets worse, tell your doctor or pharmacist||
8262|039|S|promptly.||
8262|040|S|   Remember that this medication has been prescribed because your||
8262|041|S|doctor has judged that the benefit to you is greater than the||
8262|042|S|risk of side effects. Many people using this medication do not||
8262|043|S|have serious side effects.||
8262|044|S|   Changes in your sense of taste/smell or loss of taste/smell||
8262|045|S|may occur. These side effects may improve after stopping||
8262|046|S|terbinafine, but can last for a long time or become permanent.||
8262|047|S|Tell your doctor right away if you notice either of these side||
8262|048|S|effects.||
8262|049|S|   Tell your doctor right away if you have any serious side||
8262|050|S|effects, including: vision changes, mental/mood changes (such as||
8262|051|S|depression), unexplained bleeding/bruising, unusual tiredness,||
8262|052|S|signs of kidney problems (such as change in the amount of urine).||
8262|053|S|   Terbinafine may rarely cause serious (possibly fatal) liver||
8262|054|S|disease. Get medical help right away if you have any symptoms of||
8262|055|S|liver damage, such as: nausea/vomiting that doesn't stop, loss of||
8262|056|S|appetite, severe stomach/abdominal pain, yellowing eyes/skin,||
8262|057|S|dark urine.||
8262|058|S|   A very serious allergic reaction to this drug is rare.||
8262|059|S|However, get medical help right away if you notice any symptoms||
8262|060|S|of a serious allergic reaction, including: fever, swollen lymph||
8262|061|S|nodes, rash, itching/swelling (especially of the||
8262|062|S|face/tongue/throat), severe dizziness, trouble breathing.||
8262|063|S|   This is not a complete list of possible side effects. If you||
8262|064|S|notice other effects not listed above, contact your doctor or||
8262|065|S|pharmacist.||
8262|066|S|   In the US -||
8262|067|S|   Call your doctor for medical advice about side effects. You||
8262|068|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8262|069|S|www.fda.gov/medwatch.||
8262|070|S|   In Canada - Call your doctor for medical advice about side||
8262|071|S|effects. You may report side effects to Health Canada at||
8262|072|S|1-866-234-2345.||
8262|073|B|||
8262|074|P|PRECAUTIONS:  Before taking terbinafine, tell your doctor or||
8262|075|P|pharmacist if you are allergic to it; or if you have any other||
8262|076|P|allergies. This product may contain inactive ingredients, which||
8262|077|P|can cause allergic reactions or other problems. Talk to your||
8262|078|P|pharmacist for more details.||
8262|079|P|   Before using this medication, tell your doctor or pharmacist||
8262|080|P|your medical history, especially of: immune system problems,||
8262|081|P|kidney disease, liver disease, lupus.||
8262|082|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
8262|083|P|your chance for serious side effects.||
8262|084|P|   This medication may make you more sensitive to the sun. Limit||
8262|085|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8262|086|P|sunscreen and wear protective clothing when outdoors. Tell your||
8262|087|P|doctor right away if you get sunburned or have skin||
8262|088|P|blisters/redness.||
8262|089|P|   Before having surgery, tell your doctor or dentist about all||
8262|090|P|the products you use (including prescription drugs,||
8262|091|P|nonprescription drugs, and herbal products).||
8262|092|P|   During pregnancy, this medication should be used only when||
8262|093|P|clearly needed. Fungal nail infection treatment can usually wait||
8262|094|P|until after you have had your baby. Discuss the risks and||
8262|095|P|benefits with your doctor.||
8262|096|P|   This drug passes into breast milk. Consult your doctor before||
8262|097|P|breastfeeding.||
8262|098|B|||
8262|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8262|100|I|medications work or increase your risk for serious side effects.||
8262|101|I|This document does not contain all possible drug interactions.||
8262|102|I|Keep a list of all the products you use (including||
8262|103|I|prescription/nonprescription drugs and herbal products) and share||
8262|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
8262|105|I|the dosage of any medicines without your doctor's approval.||
8262|106|I|   Terbinafine can slow down the removal of other drugs from your||
8262|107|I|body, which may affect how they work. Examples of affected drugs||
8262|108|I|include pimozide, thioridazine, among others.||
8262|109|B|||
8262|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8262|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8262|112|O|poison control center right away. US residents can call||
8262|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8262|114|B|||
8262|115|N|NOTES:  Do not share this medication with others.||
8262|116|N|   This medication has been prescribed for your current condition||
8262|117|N|only. Do not use it later for another infection unless your||
8262|118|N|doctor tells you to.||
8262|119|N|   Lab and/or medical tests (such as complete blood counts, liver||
8262|120|N|function) should be done before you start taking this medication||
8262|121|N|and while you are taking it. Keep all medical and lab||
8262|122|N|appointments. Consult your doctor for more details.||
8262|123|B|||
8262|124|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8262|125|D|remember. If it is near the time of the next dose, skip the||
8262|126|D|missed dose. Take your next dose at the regular time. Do not||
8262|127|D|double the dose to catch up.||
8262|128|B|||
8262|129|R|STORAGE:  Store at room temperature away from light and moisture.||
8262|130|R|Do not store in the bathroom. Keep all medications away from||
8262|131|R|children and pets.||
8262|132|R|   Do not flush medications down the toilet or pour them into a||
8262|133|R|drain unless instructed to do so. Properly discard this product||
8262|134|R|when it is expired or no longer needed. Consult your pharmacist||
8262|135|R|or local waste disposal company.||
8262|136|B|||
8262|137|A|Information last revised January 2025.||
8262|138|A|Copyright(c) 2025 First Databank, Inc.||
8262|139|B|||
8265|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8265|002|Z|does NOT have all possible information about this product. This||
8265|003|Z|information does not assure that this product is safe, effective,||
8265|004|Z|or appropriate for you. This information is not individual||
8265|005|Z|medical advice and does not substitute for the advice of your||
8265|006|Z|health care professional. Always ask your health care||
8265|007|Z|professional for complete information about this product and your||
8265|008|Z|specific health needs.||
8265|009|B|||
8265|010|T|SIMETHICONE - ORAL||
8265|011|F|(sye-METH-i-cone)||
8265|012|B|||
8265|013|C|COMMON BRAND NAME(S): Gas Relief, Gas-X, Mylanta Gas, Phazyme||
8265|014|B|||
8265|015|U|USES:  This product is used to relieve symptoms of extra gas such||
8265|016|U|as belching, bloating, and feelings of pressure/discomfort in the||
8265|017|U|stomach/gut. Simethicone helps break up gas bubbles in the gut.||
8265|018|U|   Check the ingredients on the label even if you have used the||
8265|019|U|product before. The manufacturer may have changed the||
8265|020|U|ingredients. Also, products with similar names may contain||
8265|021|U|different ingredients meant for different purposes. Taking the||
8265|022|U|wrong product could harm you.||
8265|023|B|||
8265|024|H|HOW TO USE:  Follow all directions on the product package. If||
8265|025|H|your doctor has prescribed this medication, take it as directed.||
8265|026|H|If you have any questions, ask your doctor or pharmacist.||
8265|027|H|   Take this product by mouth, usually as needed after meals and||
8265|028|H|at bedtime. The dosage is based on your age, medical condition,||
8265|029|H|and response to treatment. Do not increase your dose or take this||
8265|030|H|product more often than directed. Do not take more of this||
8265|031|H|product than recommended for your age.||
8265|032|H|   If you are using the chewable tablets, chew each tablet well||
8265|033|H|and swallow.||
8265|034|H|   If your condition lasts or gets worse, or if you think you may||
8265|035|H|have a serious medical problem, get medical help right away.||
8265|036|B|||
8265|037|S|SIDE EFFECTS:  This product usually has no side effects. If you||
8265|038|S|have any unusual effects, contact your doctor or pharmacist||
8265|039|S|promptly.||
8265|040|S|   If your doctor has directed you to use this product, remember||
8265|041|S|that your doctor has judged that the benefit to you is greater||
8265|042|S|than the risk of side effects. Many people using this product do||
8265|043|S|not have serious side effects.||
8265|044|S|   A very serious allergic reaction to this drug is rare.||
8265|045|S|However, get medical help right away if you notice any symptoms||
8265|046|S|of a serious allergic reaction, including: rash, itching/swelling||
8265|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8265|048|S|breathing.||
8265|049|S|   This is not a complete list of possible side effects. If you||
8265|050|S|notice other effects not listed above, contact your doctor or||
8265|051|S|pharmacist.||
8265|052|S|   In the US -||
8265|053|S|   Call your doctor for medical advice about side effects. You||
8265|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8265|055|S|www.fda.gov/medwatch.||
8265|056|S|   In Canada - Call your doctor for medical advice about side||
8265|057|S|effects. You may report side effects to Health Canada at||
8265|058|S|1-866-234-2345.||
8265|059|B|||
8265|060|P|PRECAUTIONS:  Before taking simethicone, tell your doctor or||
8265|061|P|pharmacist if you are allergic to it; or if you have any other||
8265|062|P|allergies. This product may contain inactive ingredients, which||
8265|063|P|can cause allergic reactions or other problems. Talk to your||
8265|064|P|pharmacist for more details.||
8265|065|P|   If you have any health problems, consult your doctor or||
8265|066|P|pharmacist before using this product.||
8265|067|P|   Chewable tablets may contain sugar and/or aspartame. Caution||
8265|068|P|is advised if you have diabetes, phenylketonuria (PKU), or any||
8265|069|P|other condition that requires you to limit/avoid these substances||
8265|070|P|in your diet. Ask your doctor or pharmacist about using this||
8265|071|P|product safely.||
8265|072|P|   Before having surgery, tell your doctor or dentist about all||
8265|073|P|the products you use (including prescription drugs,||
8265|074|P|nonprescription drugs, and herbal products).||
8265|075|P|   Tell your doctor if you are pregnant before using this||
8265|076|P|product.||
8265|077|P|   Simethicone does not pass into breast milk and is unlikely to||
8265|078|P|harm a nursing infant. Consult your doctor before breastfeeding.||
8265|079|B|||
8265|080|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8265|081|I|medications work or increase your risk for serious side effects.||
8265|082|I|This document does not contain all possible drug interactions.||
8265|083|I|Keep a list of all the products you use (including||
8265|084|I|prescription/nonprescription drugs and herbal products) and share||
8265|085|I|it with your doctor and pharmacist. Do not start, stop, or change||
8265|086|I|the dosage of any medicines without your doctor's approval.||
8265|087|I|   Simethicone can decrease the absorption of thyroid medications||
8265|088|I|(such as levothyroxine). If you take thyroid medication, take it||
8265|089|I|at least 4 hours before or after products that contain||
8265|090|I|simethicone.||
8265|091|B|||
8265|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8265|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8265|094|O|poison control center right away. US residents can call||
8265|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8265|096|B|||
8265|097|N|NOTES:  Keep all medical and lab appointments.||
8265|098|N|   If you have problems with gas, it may help to limit foods||
8265|099|N|known to cause gas and bloating (including beans, cabbage,||
8265|100|N|high-fat foods) or use digestive enzymes. Ask your doctor or a||
8265|101|N|dietician to help review what you eat.||
8265|102|N|   Belching may be caused by swallowing too much air.||
8265|103|N|Eating/drinking quickly, chewing gum, and smoking can cause you||
8265|104|N|to swallow more air.||
8265|105|B|||
8265|106|D|MISSED DOSE:  If you are taking this product on a regular||
8265|107|D|schedule and miss a dose, take it as soon as you remember. If it||
8265|108|D|is near the time of the next dose, skip the missed dose. Take||
8265|109|D|your next dose at the regular time. Do not double the dose to||
8265|110|D|catch up.||
8265|111|B|||
8265|112|R|STORAGE:  Store at room temperature away from light and moisture.||
8265|113|R|Do not store in the bathroom. Keep all medications away from||
8265|114|R|children and pets.||
8265|115|R|   Do not flush medications down the toilet or pour them into a||
8265|116|R|drain unless instructed to do so. Properly discard this product||
8265|117|R|when it is expired or no longer needed. Consult your pharmacist||
8265|118|R|or local waste disposal company.||
8265|119|B|||
8265|120|A|Information last revised May 2024.||
8265|121|A|Copyright(c) 2025 First Databank, Inc.||
8265|122|B|||
8268|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8268|002|Z|does NOT have all possible information about this product. This||
8268|003|Z|information does not assure that this product is safe, effective,||
8268|004|Z|or appropriate for you. This information is not individual||
8268|005|Z|medical advice and does not substitute for the advice of your||
8268|006|Z|health care professional. Always ask your health care||
8268|007|Z|professional for complete information about this product and your||
8268|008|Z|specific health needs.||
8268|009|B|||
8268|010|T|LAMIVUDINE - ORAL||
8268|011|F|(la-MIV-ue-deen)||
8268|012|B|||
8268|013|C|COMMON BRAND NAME(S): Epivir||
8268|014|B|||
8268|015|W|WARNING:  If you have hepatitis B infection along with HIV, your||
8268|016|W|hepatitis symptoms may get worse or become very serious if you||
8268|017|W|stop taking lamivudine. Talk with your doctor before stopping||
8268|018|W|this medication. Your doctor will perform liver function tests||
8268|019|W|for several months after you stop lamivudine. Tell your doctor||
8268|020|W|right away if you develop symptoms of worsening liver problems.||
8268|021|W|   Different brands of this drug have different amounts of drug.||
8268|022|W|Do not switch brands of this medication without first checking||
8268|023|W|with your doctor. If you have HIV infection (with or without||
8268|024|W|hepatitis B infection), you should be taking the higher-strength||
8268|025|W|dosage. Consult your doctor or pharmacist.||
8268|026|B|||
8268|027|U|USES:  This drug is used with other HIV medications to help||
8268|028|U|control HIV infection. It helps to decrease the amount of HIV in||
8268|029|U|your body so your immune system can work better. This lowers your||
8268|030|U|chance of getting HIV complications (such as new infections,||
8268|031|U|cancer) and improves your quality of life. Lamivudine belongs to||
8268|032|U|a class of drugs known as nucleoside reverse transcriptase||
8268|033|U|inhibitors-NRTI.||
8268|034|U|   Lamivudine is not a cure for HIV infection. To decrease your||
8268|035|U|risk of spreading HIV disease to others, continue to take all HIV||
8268|036|U|medications exactly as prescribed by your doctor. Use an||
8268|037|U|effective barrier method (latex or polyurethane condoms/dental||
8268|038|U|dams) during sexual activity as directed by your doctor. Do not||
8268|039|U|share personal items (such as needles/syringes, toothbrushes, and||
8268|040|U|razors) that may have contacted blood or other body fluids.||
8268|041|U|Consult your doctor or pharmacist for more details.||
8268|042|B|||
8268|043|V|OTHER USES:  This section contains uses of this drug that are not||
8268|044|V|listed in the approved professional labeling for the drug but||
8268|045|V|that may be prescribed by your health care professional. Use this||
8268|046|V|drug for a condition that is listed in this section only if it||
8268|047|V|has been so prescribed by your health care professional.||
8268|048|V|   This product may also be used to lessen the risk of HIV||
8268|049|V|infection after contact with the virus (for example, due to a||
8268|050|V|needle stick). Ask your doctor for more details.||
8268|051|V|   A lower-strength lamivudine product is used for hepatitis B||
8268|052|V|infection in people without HIV infection.||
8268|053|B|||
8268|054|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8268|055|H|from your pharmacist before you start taking lamivudine and each||
8268|056|H|time you get a refill. If you have any questions, ask your doctor||
8268|057|H|or pharmacist.||
8268|058|H|   Take this medication by mouth with or without food as directed||
8268|059|H|by your doctor, usually once or twice daily.||
8268|060|H|   The dosage is based on your medical condition and response to||
8268|061|H|treatment. Children's dosage is also based on weight.||
8268|062|H|   It is very important to keep taking this medication (and other||
8268|063|H|HIV medications) exactly as prescribed by your doctor. Do not||
8268|064|H|skip any doses. Do not increase your dose, take this drug more||
8268|065|H|often than prescribed, or stop taking it (or other HIV medicines)||
8268|066|H|even for a short time unless directed to do so by your doctor.||
8268|067|H|Skipping or changing your dose without approval from your doctor||
8268|068|H|may cause the amount of virus to increase, make the infection||
8268|069|H|more difficult to treat (resistant), or worsen side effects.||
8268|070|H|   For the best effect, take this medication at evenly spaced||
8268|071|H|times. To help you remember, take this medication at the same||
8268|072|H|time(s) every day.||
8268|073|B|||
8268|074|S|SIDE EFFECTS:  See also Warning section.||
8268|075|S|   Headache, dizziness, nausea, diarrhea, or trouble sleeping may||
8268|076|S|occur. If any of these effects last or get worse, tell your||
8268|077|S|doctor or pharmacist promptly.||
8268|078|S|   Remember that this medication has been prescribed because your||
8268|079|S|doctor has judged that the benefit to you is greater than the||
8268|080|S|risk of side effects. Many people using this medication do not||
8268|081|S|have serious side effects.||
8268|082|S|   Rarely, lamivudine has caused severe (sometimes fatal) liver||
8268|083|S|problems and a buildup of lactic acid in the blood (lactic||
8268|084|S|acidosis). These serious side effects may occur more often in||
8268|085|S|women and obese patients. Get medical help right away if you have||
8268|086|S|any of the following serious symptoms, including: symptoms of||
8268|087|S|liver problems (such as nausea/vomiting that doesn't stop, loss||
8268|088|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
8268|089|S|urine), symptoms of lactic acidosis (such as deep/rapid||
8268|090|S|breathing, drowsiness, nausea/vomiting).||
8268|091|S|   As your immune system gets stronger, it can begin to fight off||
8268|092|S|infections you already had, possibly causing disease symptoms to||
8268|093|S|come back. You could also have symptoms if your immune system||
8268|094|S|becomes overactive. This reaction may happen at any time (soon||
8268|095|S|after starting HIV treatment or many months later). Tell your||
8268|096|S|doctor right away if you have any serious symptoms, including:||
8268|097|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
8268|098|S|that doesn't go away, headaches that are severe or don't go away,||
8268|099|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
8268|100|S|changes, signs of infection (such as sore throat that doesn't go||
8268|101|S|away, fever, chills, swollen lymph nodes, non-healing skin||
8268|102|S|sores), signs of an overactive thyroid (such as irritability,||
8268|103|S|nervousness, heat intolerance, fast/pounding/irregular||
8268|104|S|heartbeat).||
8268|105|S|   Tell your doctor right away if you have any serious side||
8268|106|S|effects, including: mental/mood changes (such as depression),||
8268|107|S|stomach/back pain with nausea (pancreatitis), easy||
8268|108|S|bleeding/bruising, signs of anemia (unusual tiredness, rapid||
8268|109|S|heartbeat, pale/bluish skin).||
8268|110|S|   A very serious allergic reaction to this drug is rare.||
8268|111|S|However, get medical help right away if you notice any symptoms||
8268|112|S|of a serious allergic reaction, including: rash, itching/swelling||
8268|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8268|114|S|breathing.||
8268|115|S|   This is not a complete list of possible side effects. If you||
8268|116|S|notice other effects not listed above, contact your doctor or||
8268|117|S|pharmacist.||
8268|118|S|   In the US -||
8268|119|S|   Call your doctor for medical advice about side effects. You||
8268|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8268|121|S|www.fda.gov/medwatch.||
8268|122|S|   In Canada - Call your doctor for medical advice about side||
8268|123|S|effects. You may report side effects to Health Canada at||
8268|124|S|1-866-234-2345.||
8268|125|B|||
8268|126|P|PRECAUTIONS:  Before taking lamivudine, tell your doctor or||
8268|127|P|pharmacist if you are allergic to it; or if you have any other||
8268|128|P|allergies. This product may contain inactive ingredients, which||
8268|129|P|can cause allergic reactions or other problems. Talk to your||
8268|130|P|pharmacist for more details.||
8268|131|P|   Before using this medication, tell your doctor or pharmacist||
8268|132|P|your medical history, especially of: pancreatitis, kidney||
8268|133|P|problems, liver problems (such as hepatitis B or C, cirrhosis),||
8268|134|P|alcohol use.||
8268|135|P|   Avoid alcoholic beverages because they may increase your risk||
8268|136|P|for liver problems and/or pancreatitis.||
8268|137|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8268|138|P|can make you more dizzy. Do not drive, use machinery, or do||
8268|139|P|anything that needs alertness until you can do it safely. Avoid||
8268|140|P|alcoholic beverages. Talk to your doctor if you are using||
8268|141|P|marijuana (cannabis).||
8268|142|P|   Before having surgery, tell your doctor or dentist about all||
8268|143|P|the products you use (including prescription drugs,||
8268|144|P|nonprescription drugs, and herbal products).||
8268|145|P|   Children may be more sensitive to the side effects of this||
8268|146|P|drug, especially the increased risk of pancreatitis.||
8268|147|P|   Tell your doctor if you are pregnant before using this||
8268|148|P|medication. Treatment can lower the risk of passing HIV infection||
8268|149|P|to your baby. Discuss the risks and benefits with your doctor.||
8268|150|P|   This medication passes into breast milk. Because breast milk||
8268|151|P|may transmit HIV, consult your doctor before breastfeeding.||
8268|152|B|||
8268|153|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8268|154|I|medications work or increase your risk for serious side effects.||
8268|155|I|This document does not contain all possible drug interactions.||
8268|156|I|Keep a list of all the products you use (including||
8268|157|I|prescription/nonprescription drugs and herbal products) and share||
8268|158|I|it with your doctor and pharmacist. Do not start, stop, or change||
8268|159|I|the dosage of any medicines without your doctor's approval.||
8268|160|I|   Some products that may interact with this drug are: orlistat,||
8268|161|I|sorbitol.||
8268|162|I|   Emtricitabine is similar to lamivudine and should not be taken||
8268|163|I|with this medication. Check the labels on all your HIV medicines||
8268|164|I|because they may contain the same ingredients as found in this||
8268|165|I|product. Taking too much of these drugs will not necessarily||
8268|166|I|improve your condition, and may cause more side effects.||
8268|167|B|||
8268|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8268|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8268|170|O|poison control center right away. US residents can call||
8268|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8268|172|B|||
8268|173|N|NOTES:  Do not share this medication with others.||
8268|174|N|   Lab and/or medical tests (such as kidney function, liver||
8268|175|N|tests, viral load, T-cell counts) should be done while you are||
8268|176|N|taking this medication. Keep all medical and lab appointments.||
8268|177|N|Consult your doctor for more details.||
8268|178|B|||
8268|179|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8268|180|D|remember. If it is near the time of the next dose, skip the||
8268|181|D|missed dose. Take your next dose at the regular time. Do not||
8268|182|D|double the dose to catch up.||
8268|183|B|||
8268|184|R|STORAGE:  Different brands of this medication have different||
8268|185|R|storage needs. Check the product package for instructions on how||
8268|186|R|to store your brand, or ask your pharmacist. Keep all medications||
8268|187|R|away from children and pets.||
8268|188|R|   Do not flush medications down the toilet or pour them into a||
8268|189|R|drain unless instructed to do so. Properly discard this product||
8268|190|R|when it is expired or no longer needed. Consult your pharmacist||
8268|191|R|or local waste disposal company.||
8268|192|B|||
8268|193|A|Information last revised April 2025.||
8268|194|A|Copyright(c) 2025 First Databank, Inc.||
8268|195|B|||
8269|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8269|002|Z|does NOT have all possible information about this product. This||
8269|003|Z|information does not assure that this product is safe, effective,||
8269|004|Z|or appropriate for you. This information is not individual||
8269|005|Z|medical advice and does not substitute for the advice of your||
8269|006|Z|health care professional. Always ask your health care||
8269|007|Z|professional for complete information about this product and your||
8269|008|Z|specific health needs.||
8269|009|B|||
8269|010|T|CEFEPIME - INJECTION||
8269|011|F|(SEF-e-peem)||
8269|012|B|||
8269|013|C|COMMON BRAND NAME(S): Maxipime||
8269|014|B|||
8269|015|U|USES:  Cefepime is used to treat a wide variety of bacterial||
8269|016|U|infections. This medication belongs to a class of drugs known as||
8269|017|U|cephalosporin antibiotics. It works by stopping the growth of||
8269|018|U|bacteria.||
8269|019|B|||
8269|020|H|HOW TO USE:  This medication is given by injection into a muscle||
8269|021|H|or vein as directed by your doctor. The dosage is based on your||
8269|022|H|medical condition and response to treatment. Children's dosage is||
8269|023|H|also based on weight.||
8269|024|H|   If you are using this medication at home, learn all||
8269|025|H|preparation and usage instructions from your health care||
8269|026|H|professional. Before using, check this product for particles or||
8269|027|H|discoloration. If either is present, do not use the liquid. Learn||
8269|028|H|how to store and discard medical supplies safely.||
8269|029|H|   If you are using the frozen pre-mixed solution, thaw the bag||
8269|030|H|at room temperature or in the refrigerator. If the bag is thawed||
8269|031|H|in the refrigerator, let it sit at room temperature at least 1||
8269|032|H|hour before using. Do not thaw by putting in a water bath or||
8269|033|H|microwaving. After thawing, shake well and squeeze the bag to||
8269|034|H|check for leaks. Discard solution if the bag leaks. Do not||
8269|035|H|re-freeze the solution after thawing.||
8269|036|H|   For the best effect, use this antibiotic at evenly spaced||
8269|037|H|times. To help you remember, use this medication at the same||
8269|038|H|time(s) every day.||
8269|039|H|   Continue to use this medication for the full time prescribed,||
8269|040|H|even if symptoms disappear after a few days. Stopping the||
8269|041|H|medication too early may result in a return of the infection.||
8269|042|H|   Tell your doctor if your condition lasts or gets worse.||
8269|043|B|||
8269|044|S|SIDE EFFECTS:  Swelling, redness, or pain at the injection site||
8269|045|S|may occur. If any of these effects last or get worse, tell your||
8269|046|S|doctor or pharmacist promptly.||
8269|047|S|   Remember that this medication has been prescribed because your||
8269|048|S|doctor has judged that the benefit to you is greater than the||
8269|049|S|risk of side effects. Many people using this medication do not||
8269|050|S|have serious side effects.||
8269|051|S|   Tell your doctor right away if you have any serious side||
8269|052|S|effects, including: easy bruising/bleeding, unusual tiredness,||
8269|053|S|uncontrollable movements, mental/mood changes (such as confusion,||
8269|054|S|hallucinations, decreased alertness), seizures, trouble speaking,||
8269|055|S|signs of kidney problems (such as change in the amount of urine),||
8269|056|S|signs of liver problems (such as nausea/vomiting that doesn't||
8269|057|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
8269|058|S|eyes/skin, dark urine).||
8269|059|S|   This medication may rarely cause a severe intestinal condition||
8269|060|S|due to a bacteria called C. difficile. This condition may occur||
8269|061|S|during treatment or weeks to months after treatment has stopped.||
8269|062|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8269|063|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8269|064|S|stool.||
8269|065|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8269|066|S|products because they may make symptoms worse.||
8269|067|S|   Use of this medication for prolonged or repeated periods may||
8269|068|S|result in oral thrush or a new yeast infection. Contact your||
8269|069|S|doctor if you notice white patches in your mouth, a change in||
8269|070|S|vaginal discharge, or other new symptoms.||
8269|071|S|   A very serious allergic reaction to this drug is rare.||
8269|072|S|However, get medical help right away if you notice any symptoms||
8269|073|S|of a serious allergic reaction, including: rash, itching/swelling||
8269|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8269|075|S|breathing.||
8269|076|S|   This is not a complete list of possible side effects. If you||
8269|077|S|notice other effects not listed above, contact your doctor or||
8269|078|S|pharmacist.||
8269|079|S|   In the US -||
8269|080|S|   Call your doctor for medical advice about side effects. You||
8269|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8269|082|S|www.fda.gov/medwatch.||
8269|083|S|   In Canada - Call your doctor for medical advice about side||
8269|084|S|effects. You may report side effects to Health Canada at||
8269|085|S|1-866-234-2345.||
8269|086|B|||
8269|087|P|PRECAUTIONS:  Before using cefepime, tell your doctor or||
8269|088|P|pharmacist if you are allergic to it; or to other antibiotics||
8269|089|P|(such as penicillins, other cephalosporins); or if you have any||
8269|090|P|other allergies. This product may contain inactive ingredients,||
8269|091|P|which can cause allergic reactions or other problems. Talk to||
8269|092|P|your pharmacist for more details.||
8269|093|P|   Before using this medication, tell your doctor or pharmacist||
8269|094|P|your medical history, especially of: kidney disease,||
8269|095|P|stomach/intestinal diseases (such as colitis).||
8269|096|P|   Cefepime may cause live bacterial vaccines (such as typhoid||
8269|097|P|vaccine) to not work well. Tell your health care professional||
8269|098|P|that you are using cefepime before having any||
8269|099|P|immunizations/vaccinations.||
8269|100|P|   Before having surgery, tell your doctor or dentist about all||
8269|101|P|the products you use (including prescription drugs,||
8269|102|P|nonprescription drugs, and herbal products).||
8269|103|P|   Tell your doctor if you are pregnant before using this||
8269|104|P|medication.||
8269|105|P|   This medication passes into breast milk in small amounts and||
8269|106|P|is unlikely to harm a nursing infant. Consult your doctor before||
8269|107|P|breastfeeding.||
8269|108|B|||
8269|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8269|110|I|medications work or increase your risk for serious side effects.||
8269|111|I|This document does not contain all possible drug interactions.||
8269|112|I|Keep a list of all the products you use (including||
8269|113|I|prescription/nonprescription drugs and herbal products) and share||
8269|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
8269|115|I|the dosage of any medicines without your doctor's approval.||
8269|116|I|   This medication may interfere with certain lab tests||
8269|117|I|(including certain urine glucose tests), possibly causing false||
8269|118|I|test results. Make sure lab personnel and all your doctors know||
8269|119|I|you use this drug.||
8269|120|B|||
8269|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8269|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8269|123|O|poison control center right away. US residents can call||
8269|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8269|125|O|Symptoms of overdose may include: seizures.||
8269|126|B|||
8269|127|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
8269|128|N|kidney function) should be done while you are using this||
8269|129|N|medication. Keep all medical and lab appointments.||
8269|130|B|||
8269|131|D|MISSED DOSE:  It is important to get each dose of this medication||
8269|132|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8269|133|D|right away for a new dosing schedule. Do not double the dose to||
8269|134|D|catch up.||
8269|135|B|||
8269|136|R|STORAGE:  Consult the product instructions and your pharmacist||
8269|137|R|for storage details. Keep all medications away from children and||
8269|138|R|pets.||
8269|139|R|   Do not flush medications down the toilet or pour them into a||
8269|140|R|drain unless instructed to do so. Properly discard this product||
8269|141|R|when it is expired or no longer needed. Consult your pharmacist||
8269|142|R|or local waste disposal company.||
8269|143|B|||
8269|144|A|Information last revised January 2025.||
8269|145|A|Copyright(c) 2025 First Databank, Inc.||
8269|146|B|||
8271|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8271|002|Z|does NOT have all possible information about this product. This||
8271|003|Z|information does not assure that this product is safe, effective,||
8271|004|Z|or appropriate for you. This information is not individual||
8271|005|Z|medical advice and does not substitute for the advice of your||
8271|006|Z|health care professional. Always ask your health care||
8271|007|Z|professional for complete information about this product and your||
8271|008|Z|specific health needs.||
8271|009|B|||
8271|010|T|DANAPAROID - INJECTION||
8271|011|F|(dah-NAP-uh-roid)||
8271|012|B|||
8271|013|W|WARNING:  Tell your doctor you are using this medication before||
8271|014|W|undergoing any procedure involving spinal puncture/anesthesia.||
8271|015|W|Using this medication before or after these procedures has caused||
8271|016|W|major bruising or bleeding (epidural or spinal hematoma) inside||
8271|017|W|the body. This effect may cause an inability to move (paralysis),||
8271|018|W|which may be permanent. Get medical help right away if you have||
8271|019|W|any of these serious side effects: tingling, weakness, numbness,||
8271|020|W|pain, or loss of control of your bladder or bowels.||
8271|021|W|   This risk is increased when this medication is used with other||
8271|022|W|"blood thinning" medications (such as aspirin, clopidogrel,||
8271|023|W|rivaroxaban, warfarin), NSAIDs (such as ibuprofen, naproxen), or||
8271|024|W|certain medication delivery devices (indwelling epidural||
8271|025|W|catheters). Tell your doctor if you are taking any of these||
8271|026|W|medications. Do not stop using any prescribed medication or||
8271|027|W|device without first talking to your doctor.||
8271|028|W|   Your doctor will monitor you closely while you are using this||
8271|029|W|medication.||
8271|030|B|||
8271|031|U|USES:  Danaparoid is used to prevent harmful blood clots,||
8271|032|U|especially in patients who have had or are having a certain bad||
8271|033|U|reaction to heparin (Heparin-Induced Thrombocytopenia-HIT).||
8271|034|U|Preventing harmful blood clots helps to reduce the risk of a||
8271|035|U|stroke or heart attack. This medication helps keep your blood||
8271|036|U|flowing smoothly by lowering the activity of certain substances||
8271|037|U|in the blood that cause clotting. Danaparoid is an anticoagulant||
8271|038|U|(commonly called a "blood thinner").||
8271|039|U|   Conditions that increase your risk of developing blood clots||
8271|040|U|include certain types of surgeries (such as hip replacement or||
8271|041|U|abdominal surgery) and long periods of being in one position||
8271|042|U|(immobile). For some medical conditions, danaparoid may be used||
8271|043|U|with other "blood thinners."||
8271|044|B|||
8271|045|H|HOW TO USE:  This medication is given by injection under the skin||
8271|046|H|as directed by your doctor, usually 2 or 3 times a day. Do not||
8271|047|H|inject into a muscle. For some conditions, this medication may be||
8271|048|H|given by injection into a vein as directed by your doctor by a||
8271|049|H|health care professional. The dosage and length of treatment are||
8271|050|H|based on your medical condition, weight, and response to||
8271|051|H|treatment.||
8271|052|H|   If you are using this medication at home, learn all||
8271|053|H|preparation and usage instructions from your health care||
8271|054|H|professional. Before using, check this product for particles or||
8271|055|H|discoloration. If either is present, do not use the liquid.||
8271|056|H|Before injecting each dose, clean the skin you are going to||
8271|057|H|inject into (the injection site) with rubbing alcohol. Change the||
8271|058|H|injection site each time to lessen injury under the skin. To||
8271|059|H|lessen bruising, do not rub the injection site after a shot.||
8271|060|H|Learn how to store and discard medical supplies safely.||
8271|061|H|   Use this medication regularly to get the most benefit from it.||
8271|062|H|To help you remember, use it at the same times each day.||
8271|063|B|||
8271|064|S|SIDE EFFECTS:  See also Warning section.||
8271|065|S|   Nausea, constipation, fever, headache, weakness, or||
8271|066|S|pain/redness/irritation at the injection site may occur. If any||
8271|067|S|of these effects last or get worse, tell your doctor or||
8271|068|S|pharmacist promptly.||
8271|069|S|   Remember that this medication has been prescribed because your||
8271|070|S|doctor has judged that the benefit to you is greater than the||
8271|071|S|risk of side effects. Many people using this medication do not||
8271|072|S|have serious side effects.||
8271|073|S|   This medication can cause bleeding if its effect is too||
8271|074|S|strong. Tell your doctor right away if you have any serious signs||
8271|075|S|of bleeding, including: unusual pain/swelling/discomfort,||
8271|076|S|unusual/prolonged bleeding, unusual/easy bruising, dark urine,||
8271|077|S|black stools, severe headache, confusion, vision changes, unusual||
8271|078|S|dizziness, fainting, seizures, weakness, numbness.||
8271|079|S|   A very serious allergic reaction to this drug is rare.||
8271|080|S|However, get medical help right away if you notice any symptoms||
8271|081|S|of a serious allergic reaction, including: rash, itching/swelling||
8271|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8271|083|S|breathing.||
8271|084|S|   This is not a complete list of possible side effects. If you||
8271|085|S|notice other effects not listed above, contact your doctor or||
8271|086|S|pharmacist.||
8271|087|S|   In the US -||
8271|088|S|   Call your doctor for medical advice about side effects. You||
8271|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8271|090|S|www.fda.gov/medwatch.||
8271|091|S|   In Canada - Call your doctor for medical advice about side||
8271|092|S|effects. You may report side effects to Health Canada at||
8271|093|S|1-866-234-2345.||
8271|094|B|||
8271|095|P|PRECAUTIONS:  Before using danaparoid, tell your doctor or||
8271|096|P|pharmacist if you are allergic to it; or to heparins or pork||
8271|097|P|products; or if you have any other allergies. This product may||
8271|098|P|contain inactive ingredients (such as sulfites), which can cause||
8271|099|P|allergic reactions or other problems. Talk to your pharmacist for||
8271|100|P|more details.||
8271|101|P|   Before using this medication, tell your doctor or pharmacist||
8271|102|P|your medical history, especially of: artificial heart valves,||
8271|103|P|bleeding/blood problems, certain eye problems (hemorrhagic or||
8271|104|P|diabetic retinopathy), high blood pressure, infection of the||
8271|105|P|heart, kidney disease, liver disease, certain stomach/intestinal||
8271|106|P|problems (such as current or recent ulcers), stroke, recent||
8271|107|P|spinal procedures/puncture/surgery, recent eye/ear/brain surgery,||
8271|108|P|asthma.||
8271|109|P|   Limit alcohol while taking this drug because it may increase||
8271|110|P|the risk of stomach bleeding.||
8271|111|P|   Before having surgery, tell your doctor or dentist about all||
8271|112|P|the products you use (including prescription drugs,||
8271|113|P|nonprescription drugs, and herbal products).||
8271|114|P|   This medication can rarely cause heavy bleeding. Be very||
8271|115|P|careful to avoid injuries (for example, due to contact sports).||
8271|116|P|Use an electric razor when shaving and a soft toothbrush when||
8271|117|P|brushing your teeth.||
8271|118|P|   Older adults may be more sensitive to the side effects of this||
8271|119|P|drug, especially bleeding.||
8271|120|P|   During pregnancy, this medication should be used only when||
8271|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
8271|122|P|   It is unknown if this drug passes into breast milk. Consult||
8271|123|P|your doctor before breastfeeding.||
8271|124|B|||
8271|125|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8271|126|I|medications work or increase your risk for serious side effects.||
8271|127|I|This document does not contain all possible drug interactions.||
8271|128|I|Keep a list of all the products you use (including||
8271|129|I|prescription/nonprescription drugs and herbal products) and share||
8271|130|I|it with your doctor and pharmacist. Do not start, stop, or change||
8271|131|I|the dosage of any medicines without your doctor's approval.||
8271|132|I|   A product that may interact with this drug is: mifepristone.||
8271|133|I|   This medication is sometimes used with other drugs that have||
8271|134|I|"blood-thinning" or anti-platelet effects such as acenocoumarol,||
8271|135|I|aspirin, clopidogrel, or warfarin. When these combinations are||
8271|136|I|prescribed by your doctor, you will require closer monitoring to||
8271|137|I|lessen your risk of bleeding. Keep all medical and lab||
8271|138|I|appointments.||
8271|139|I|   Check all prescription and nonprescription medicine labels||
8271|140|I|carefully since many contain pain relievers/fever reducers||
8271|141|I|(NSAIDs such as ibuprofen, naproxen, aspirin) that can increase||
8271|142|I|the risk of bleeding/anti-platelet effect when used with||
8271|143|I|danaparoid. However, if your doctor has told you to take low-dose||
8271|144|I|aspirin to prevent heart attack or stroke or to prevent clotting||
8271|145|I|of artificial heart valves (usually 81-162 milligrams a day), you||
8271|146|I|should keep taking the aspirin unless your doctor tells you not||
8271|147|I|to. Ask your doctor or pharmacist for more details.||
8271|148|I|   This medication may interfere with certain lab tests, possibly||
8271|149|I|causing false test results. Make sure lab personnel and all your||
8271|150|I|doctors know you use this drug.||
8271|151|B|||
8271|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8271|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8271|154|O|poison control center right away. US residents can call||
8271|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8271|156|O|Symptoms of overdose may include: unusual bleeding and bruising.||
8271|157|B|||
8271|158|N|NOTES:  Do not share this medication with others.||
8271|159|N|   Lab and/or medical tests (such as complete blood count, blood||
8271|160|N|pressure, anti-factor Xa blood levels) should be done while you||
8271|161|N|are using this medication. Keep all medical and lab appointments.||
8271|162|N|Consult your doctor for more details.||
8271|163|B|||
8271|164|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8271|165|D|If it is near the time of the next dose, skip the missed dose.||
8271|166|D|Use your next dose at the regular time. Do not double the dose to||
8271|167|D|catch up.||
8271|168|B|||
8271|169|R|STORAGE:  Store in the refrigerator or at room temperature away||
8271|170|R|from light. Do not freeze. Keep all medications away from||
8271|171|R|children and pets.||
8271|172|R|   Do not flush medications down the toilet or pour them into a||
8271|173|R|drain unless instructed to do so. Properly discard this product||
8271|174|R|when it is expired or no longer needed. Consult your pharmacist||
8271|175|R|or local waste disposal company.||
8271|176|B|||
8271|177|M|MEDICAL ALERT:  Your condition can cause complications in a||
8271|178|M|medical emergency. For information about enrolling in MedicAlert,||
8271|179|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8271|180|B|||
8271|181|A|Information last revised October 2024.||
8271|182|A|Copyright(c) 2025 First Databank, Inc.||
8271|183|B|||
8272|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8272|002|Z|does NOT have all possible information about this product. This||
8272|003|Z|information does not assure that this product is safe, effective,||
8272|004|Z|or appropriate for you. This information is not individual||
8272|005|Z|medical advice and does not substitute for the advice of your||
8272|006|Z|health care professional. Always ask your health care||
8272|007|Z|professional for complete information about this product and your||
8272|008|Z|specific health needs.||
8272|009|B|||
8272|010|T|VALRUBICIN - INTRAVESICAL||
8272|011|F|(val-REWB-eh-sin)||
8272|012|B|||
8272|013|C|COMMON BRAND NAME(S): Valstar||
8272|014|B|||
8272|015|U|USES:  Valrubicin is used to treat bladder cancer. The usual||
8272|016|U|treatment for bladder cancer is surgery. However, if you and your||
8272|017|U|doctor decide that the risk of surgery is greater than its||
8272|018|U|benefit or that surgery may be delayed, this medication may be||
8272|019|U|used as part of your treatment.||
8272|020|U|   This medication belongs to a class of drugs known as||
8272|021|U|anthracyclines and works by slowing or stopping the growth of||
8272|022|U|cancer cells.||
8272|023|U|   This medication may not cure your cancer. Delaying surgery||
8272|024|U|could lead to a more serious illness (metastatic cancer). Discuss||
8272|025|U|the risks and benefits of this medication with your doctor.||
8272|026|B|||
8272|027|H|HOW TO USE:  This medication is given by placement into the||
8272|028|H|bladder as directed by your doctor, usually once weekly for 6||
8272|029|H|weeks. Do not give by injection into a vein or muscle or under||
8272|030|H|the skin. After this medication is placed through a tube||
8272|031|H|(catheter), it is usually left in the bladder for 2 hours, then||
8272|032|H|released by urinating.||
8272|033|H|   Drink plenty of fluids after each treatment with this||
8272|034|H|medication unless otherwise directed by your doctor. Doing so||
8272|035|H|helps clear it from your body and decrease side effects.||
8272|036|B|||
8272|037|S|SIDE EFFECTS:  Bladder irritation, with symptoms such as pain,||
8272|038|S|spasm, and frequent urge to urinate, usually occurs. This||
8272|039|S|medication usually will cause your urine to turn a reddish color.||
8272|040|S|This is a normal, harmless effect of the drug and should not be||
8272|041|S|mistaken for blood in your urine. If any of these effects last or||
8272|042|S|get worse after 24 hours, tell your doctor right away.||
8272|043|S|   Infrequent side effects include nausea, abdominal/stomach||
8272|044|S|pain, diarrhea, headache, weakness, dizziness, or back pain. If||
8272|045|S|any of these effects last or get worse, tell your doctor.||
8272|046|S|   Remember that this medication has been prescribed because your||
8272|047|S|doctor has judged that the benefit to you is greater than the||
8272|048|S|risk of side effects. Many people using this medication do not||
8272|049|S|have serious side effects.||
8272|050|S|   Tell your doctor right away if you have any serious side||
8272|051|S|effects, including: bloody urine, signs of infection (such as||
8272|052|S|fever, chills), unusual tiredness.||
8272|053|S|   A very serious allergic reaction to this drug is rare.||
8272|054|S|However, get medical help right away if you notice any symptoms||
8272|055|S|of a serious allergic reaction, including: rash, itching/swelling||
8272|056|S|(especially of the face/tongue/throat), trouble breathing, severe||
8272|057|S|dizziness.||
8272|058|S|   This is not a complete list of possible side effects. If you||
8272|059|S|notice other effects not listed above, contact your doctor or||
8272|060|S|pharmacist.||
8272|061|S|   In the US -||
8272|062|S|   Call your doctor for medical advice about side effects. You||
8272|063|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8272|064|S|www.fda.gov/medwatch.||
8272|065|S|   In Canada - Call your doctor for medical advice about side||
8272|066|S|effects. You may report side effects to Health Canada at||
8272|067|S|1-866-234-2345.||
8272|068|B|||
8272|069|P|PRECAUTIONS:  Before using valrubicin, tell your doctor or||
8272|070|P|pharmacist if you are allergic to it; or to other anthracyclines||
8272|071|P|(such as doxorubicin); or if you have any other allergies. This||
8272|072|P|product may contain inactive ingredients (such as||
8272|073|P|polyoxyethylated castor oil), which can cause allergic reactions||
8272|074|P|or other problems. Talk to your pharmacist for more details.||
8272|075|P|   Before using this medication, tell your doctor or pharmacist||
8272|076|P|your medical history, especially of: small bladder size or other||
8272|077|P|bladder problems (such as perforation, incontinence), current||
8272|078|P|urinary infection/symptoms of bladder irritation (including pain,||
8272|079|P|spasm, frequent urge to urinate).||
8272|080|P|   Before having surgery, tell your doctor or dentist about all||
8272|081|P|the products you use (including prescription drugs,||
8272|082|P|nonprescription drugs, and herbal products).||
8272|083|P|   Tell your doctor if you are pregnant or plan to become||
8272|084|P|pregnant. You should not become pregnant while using valrubicin.||
8272|085|P|Valrubicin may harm an unborn baby. Women using this medication||
8272|086|P|should ask about reliable forms of birth control during treatment||
8272|087|P|and for 6 months after the last dose. Men using this medication||
8272|088|P|should ask about reliable forms of birth control during treatment||
8272|089|P|and for 3 months after the last dose. If you or your partner||
8272|090|P|becomes pregnant, talk to your doctor right away about the risks||
8272|091|P|and benefits of this medication.||
8272|092|P|   It is unknown if this drug passes into breast milk. Because of||
8272|093|P|the possible risk to the infant, breastfeeding is not recommended||
8272|094|P|while using this drug. Consult your doctor before breastfeeding.||
8272|095|B|||
8272|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8272|097|I|medications work or increase your risk for serious side effects.||
8272|098|I|This document does not contain all possible drug interactions.||
8272|099|I|Keep a list of all the products you use (including||
8272|100|I|prescription/nonprescription drugs and herbal products) and share||
8272|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
8272|102|I|the dosage of any medicines without your doctor's approval.||
8272|103|B|||
8272|104|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8272|105|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8272|106|O|poison control center right away. US residents can call||
8272|107|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8272|108|B|||
8272|109|N|NOTES:  Lab and/or medical tests (such as biopsy, cystoscopy,||
8272|110|N|urine cytology) should be done while you are using this||
8272|111|N|medication. Keep all medical and lab appointments. Consult your||
8272|112|N|doctor for more details.||
8272|113|B|||
8272|114|D|MISSED DOSE:  It is important to get each dose of this medication||
8272|115|D|as scheduled. If you miss a dose, ask your doctor right away for||
8272|116|D|a new dosing schedule. Do not double the dose to catch up.||
8272|117|B|||
8272|118|R|STORAGE:  Not applicable. This medication is given in a hospital||
8272|119|R|or clinic and will not be stored at home.||
8272|120|B|||
8272|121|A|Information last revised November 2024.||
8272|122|A|Copyright(c) 2025 First Databank, Inc.||
8272|123|B|||
8273|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8273|002|Z|does NOT have all possible information about this product. This||
8273|003|Z|information does not assure that this product is safe, effective,||
8273|004|Z|or appropriate for you. This information is not individual||
8273|005|Z|medical advice and does not substitute for the advice of your||
8273|006|Z|health care professional. Always ask your health care||
8273|007|Z|professional for complete information about this product and your||
8273|008|Z|specific health needs.||
8273|009|B|||
8273|010|T|LETROZOLE - ORAL||
8273|011|F|(LET-tro-zole)||
8273|012|B|||
8273|013|C|COMMON BRAND NAME(S): Femara||
8273|014|B|||
8273|015|U|USES:  This medication is used to treat certain types of breast||
8273|016|U|cancer (such as hormone-receptor-positive breast cancer) in women||
8273|017|U|after menopause. Letrozole is also used to help prevent the||
8273|018|U|cancer from returning. Some breast cancers are made to grow||
8273|019|U|faster by a natural hormone called estrogen. Letrozole decreases||
8273|020|U|the amount of estrogen the body makes and helps to slow or||
8273|021|U|reverse the growth of these breast cancers.||
8273|022|B|||
8273|023|V|OTHER USES:  This section contains uses of this drug that are not||
8273|024|V|listed in the approved professional labeling for the drug but||
8273|025|V|that may be prescribed by your health care professional. Use this||
8273|026|V|drug for a condition that is listed in this section only if it||
8273|027|V|has been so prescribed by your health care professional.||
8273|028|V|   This drug may also be used for infertility in women.||
8273|029|B|||
8273|030|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8273|031|H|from your pharmacist before you start using letrozole and each||
8273|032|H|time you get a refill. If you have any questions, ask your doctor||
8273|033|H|or pharmacist.||
8273|034|H|   Take this medication by mouth with or without food as directed||
8273|035|H|by your doctor, usually once daily.||
8273|036|H|   Dosage is based on your medical condition and response to||
8273|037|H|treatment.||
8273|038|H|   Use this medication regularly to get the most benefit from it.||
8273|039|H|To help you remember, take it at the same time each day.||
8273|040|H|   Since this drug can be absorbed through the skin and lungs,||
8273|041|H|women who are pregnant should not handle this medication or||
8273|042|H|breathe the dust from the tablets. (See also Precautions||
8273|043|H|section.)||
8273|044|H|   Tell your doctor right away if your condition gets worse (such||
8273|045|H|as you get new breast lumps).||
8273|046|B|||
8273|047|S|SIDE EFFECTS:  Hot flashes, hair loss, bone pain, tiredness,||
8273|048|S|unusual sweating, nausea, diarrhea, dizziness, and trouble||
8273|049|S|sleeping may occur. If any of these effects last or get worse,||
8273|050|S|tell your doctor or pharmacist promptly.||
8273|051|S|   Remember that this medication has been prescribed because your||
8273|052|S|doctor has judged that the benefit to you is greater than the||
8273|053|S|risk of side effects. Many people using this medication do not||
8273|054|S|have serious side effects.||
8273|055|S|   Tell your doctor right away if you have any serious side||
8273|056|S|effects, including: nausea/vomiting that doesn't stop, bone||
8273|057|S|fractures, pain/swelling of the joint/muscle/tendon, mental/mood||
8273|058|S|changes (such as depression, anxiety), swelling of arms/legs,||
8273|059|S|blurred vision, unusual tiredness, dark urine, yellowing||
8273|060|S|eyes/skin..||
8273|061|S|   This medication (and cancer) may rarely cause serious problems||
8273|062|S|from blood clots (such as heart attack, stroke, blood clots in||
8273|063|S|the lungs or legs). Get medical help right away if you||
8273|064|S|experience: shortness of breath/rapid breathing, chest/jaw/left||
8273|065|S|arm pain, confusion, sudden dizziness/fainting,||
8273|066|S|pain/swelling/warmth in the groin/calf, trouble speaking,||
8273|067|S|weakness on one side of the body, sudden vision changes,||
8273|068|S|sudden/severe headaches, unusual sweating.||
8273|069|S|   A very serious allergic reaction to this drug is rare.||
8273|070|S|However, get medical help right away if you notice any symptoms||
8273|071|S|of a serious allergic reaction, including: rash, itching/swelling||
8273|072|S|(especially of the face/tongue/throat/neck), severe dizziness,||
8273|073|S|trouble breathing.||
8273|074|S|   This is not a complete list of possible side effects. If you||
8273|075|S|notice other effects not listed above, contact your doctor or||
8273|076|S|pharmacist.||
8273|077|S|   In the US -||
8273|078|S|   Call your doctor for medical advice about side effects. You||
8273|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8273|080|S|www.fda.gov/medwatch.||
8273|081|S|   In Canada - Call your doctor for medical advice about side||
8273|082|S|effects. You may report side effects to Health Canada at||
8273|083|S|1-866-234-2345.||
8273|084|B|||
8273|085|P|PRECAUTIONS:  Before taking letrozole, tell your doctor or||
8273|086|P|pharmacist if you are allergic to it; or to anastrozole; or if||
8273|087|P|you have any other allergies. This product may contain inactive||
8273|088|P|ingredients, which can cause allergic reactions or other||
8273|089|P|problems. Talk to your pharmacist for more details.||
8273|090|P|   Before using this medication, tell your doctor or pharmacist||
8273|091|P|your medical history, especially of: high blood fats||
8273|092|P|(cholesterol), bone problems (such as osteopenia, osteoporosis),||
8273|093|P|stroke or blood clots, heart disease (such as chest pain, heart||
8273|094|P|attack, heart failure), high blood pressure, kidney problems,||
8273|095|P|liver problems.||
8273|096|P|   This drug may make you dizzy or tired or rarely blur your||
8273|097|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
8273|098|P|or tired. Do not drive, use machinery, or do anything that needs||
8273|099|P|alertness or clear vision until you can do it safely. Limit||
8273|100|P|alcoholic beverages. Talk to your doctor if you are using||
8273|101|P|marijuana (cannabis).||
8273|102|P|   Before having surgery, tell your doctor or dentist about all||
8273|103|P|the products you use (including prescription drugs,||
8273|104|P|nonprescription drugs, and herbal products).||
8273|105|P|   This medication must not be used during pregnancy. It may harm||
8273|106|P|an unborn baby. Letrozole is used mainly in women after||
8273|107|P|menopause. If you have recently gone through menopause, discuss||
8273|108|P|the need for use of reliable forms of birth control while taking||
8273|109|P|this medication and for 3 weeks after stopping treatment with||
8273|110|P|your doctor. Do not use birth control products containing||
8273|111|P|estrogen. Consult your doctor for more details. If you become||
8273|112|P|pregnant or think you may be pregnant, tell your doctor right||
8273|113|P|away. (See also How to Use section.)||
8273|114|P|   It is unknown if this drug passes into breast milk. Because of||
8273|115|P|the possible risk to the infant, breastfeeding is not recommended||
8273|116|P|while using this drug and for at least 3 weeks after the last||
8273|117|P|dose. Consult your doctor before breastfeeding.||
8273|118|B|||
8273|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8273|120|I|medications work or increase your risk for serious side effects.||
8273|121|I|This document does not contain all possible drug interactions.||
8273|122|I|Keep a list of all the products you use (including||
8273|123|I|prescription/nonprescription drugs and herbal products) and share||
8273|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
8273|125|I|the dosage of any medicines without your doctor's approval.||
8273|126|I|   Some products that may interact with this drug include:||
8273|127|I|estrogens (such as ethinyl estradiol, conjugated estrogens),||
8273|128|I|estrogen blockers (such as anastrozole, tamoxifen), tibolone.||
8273|129|B|||
8273|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8273|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8273|132|O|poison control center right away. US residents can call||
8273|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8273|134|B|||
8273|135|N|NOTES:  Do not share this medication with others.||
8273|136|N|   Lab and/or medical tests (such as bone density tests,||
8273|137|N|cholesterol levels, liver function) should be done while you are||
8273|138|N|taking this medication. Keep all medical and lab appointments.||
8273|139|N|Consult your doctor for more details.||
8273|140|N|   This medication can increase the risk of bone loss||
8273|141|N|(osteoporosis). Talk with your doctor about your risk, and about||
8273|142|N|available treatments for osteoporosis. Lifestyle changes that may||
8273|143|N|help reduce the risk of bone problems include doing||
8273|144|N|weight-bearing exercise, stopping smoking, limiting alcohol, and||
8273|145|N|getting enough calcium and vitamin D.||
8273|146|B|||
8273|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8273|148|D|remember. If it is near the time of the next dose, skip the||
8273|149|D|missed dose. Take your next dose at the regular time. Do not||
8273|150|D|double the dose to catch up.||
8273|151|B|||
8273|152|R|STORAGE:  Store at room temperature away from light and moisture.||
8273|153|R|Do not store in the bathroom. Keep all medications away from||
8273|154|R|children and pets.||
8273|155|R|   Do not flush medications down the toilet or pour them into a||
8273|156|R|drain unless instructed to do so. Properly discard this product||
8273|157|R|when it is expired or no longer needed. Consult your pharmacist||
8273|158|R|or local waste disposal company.||
8273|159|B|||
8273|160|A|Information last revised September 2025.||
8273|161|A|Copyright(c) 2025 First Databank, Inc.||
8273|162|B|||
8274|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8274|002|Z|does NOT have all possible information about this product. This||
8274|003|Z|information does not assure that this product is safe, effective,||
8274|004|Z|or appropriate for you. This information is not individual||
8274|005|Z|medical advice and does not substitute for the advice of your||
8274|006|Z|health care professional. Always ask your health care||
8274|007|Z|professional for complete information about this product and your||
8274|008|Z|specific health needs.||
8274|009|B|||
8274|010|T|QUETIAPINE - ORAL||
8274|011|F|(kweh-TIE-ah-peen)||
8274|012|B|||
8274|013|C|COMMON BRAND NAME(S): Seroquel||
8274|014|B|||
8274|015|W|WARNING:  There may be a slightly increased risk of serious,||
8274|016|W|possibly fatal side effects (such as stroke, heart failure,||
8274|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
8274|018|W|by older adults with dementia. This medication is not approved||
8274|019|W|for the treatment of dementia-related behavior problems. Discuss||
8274|020|W|the risks and benefits of this medication, as well as other||
8274|021|W|effective and possibly safer treatments for dementia-related||
8274|022|W|behavior problems, with the doctor.||
8274|023|W|   Quetiapine is used to treat certain mental/mood disorders||
8274|024|W|(such as schizophrenia, bipolar disorder, sudden episodes of||
8274|025|W|mania or depression associated with bipolar disorder). Drugs used||
8274|026|W|to treat depression can help prevent suicidal thoughts/attempts||
8274|027|W|and provide other important benefits. However, studies have shown||
8274|028|W|that a small number of people (especially people younger than 25)||
8274|029|W|who take drugs to treat depression may experience worsening||
8274|030|W|depression, other mental/mood symptoms, or suicidal||
8274|031|W|thoughts/attempts. It is very important to talk with the doctor||
8274|032|W|about the risks and benefits of drugs used to treat depression||
8274|033|W|(especially for people younger than 25), even if treatment is not||
8274|034|W|for a mental/mood condition.||
8274|035|W|   Tell the doctor right away if you notice worsening||
8274|036|W|depression/other psychiatric conditions, unusual behavior changes||
8274|037|W|(including possible suicidal thoughts/attempts), or other||
8274|038|W|mental/mood changes (including new/worsening anxiety, panic||
8274|039|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
8274|040|W|impulsive actions, severe restlessness, very rapid speech). Be||
8274|041|W|especially watchful for these symptoms when a new drug to treat||
8274|042|W|depression is started or when the dose is changed.||
8274|043|W|   This medication is not approved for use in children under 10||
8274|044|W|years old.||
8274|045|B|||
8274|046|U|USES:  This medication is used to treat certain mental/mood||
8274|047|U|disorders (such as schizophrenia, bipolar disorder, sudden||
8274|048|U|episodes of mania or depression associated with bipolar||
8274|049|U|disorder). Quetiapine belongs to a class of drugs known as||
8274|050|U|atypical antipsychotics. It works by helping to restore the||
8274|051|U|balance of certain natural substances in the brain.||
8274|052|B|||
8274|053|V|OTHER USES:  This section contains uses of this drug that are not||
8274|054|V|listed in the approved professional labeling for the drug but||
8274|055|V|that may be prescribed by your health care professional. Use this||
8274|056|V|drug for a condition that is listed in this section only if it||
8274|057|V|has been so prescribed by your health care professional.||
8274|058|V|   This drug may also be used in combination with other||
8274|059|V|medication for depression. If you are using quetiapine in||
8274|060|V|combination with other medication for depression, carefully read||
8274|061|V|the drug information for the other medication.||
8274|062|B|||
8274|063|H|HOW TO USE:  Read the Medication Guide and, if available, the||
8274|064|H|Patient Information Leaflet provided by your pharmacist before||
8274|065|H|you start using quetiapine and each time you get a refill. If you||
8274|066|H|have any questions, ask your doctor or pharmacist.||
8274|067|H|   Take this medication by mouth as directed by your doctor,||
8274|068|H|usually 2 or 3 times daily with or without food. For the||
8274|069|H|treatment of depression associated with bipolar disorder, take||
8274|070|H|this medication by mouth as directed by your doctor, usually once||
8274|071|H|daily at bedtime.||
8274|072|H|   The dosage is based on your medical condition, response to||
8274|073|H|treatment, and other medications you may be taking. Be sure to||
8274|074|H|tell your doctor and pharmacist about all the products you use||
8274|075|H|(including prescription drugs, nonprescription drugs, and herbal||
8274|076|H|products).||
8274|077|H|   To reduce your risk of side effects, your doctor may direct||
8274|078|H|you to start this medication at a low dose and gradually increase||
8274|079|H|your dose. Follow your doctor's instructions carefully. Take this||
8274|080|H|medication regularly to get the most benefit from it. To help you||
8274|081|H|remember, take it at the same times each day.||
8274|082|H|   Do not increase your dose or use this drug more often or for||
8274|083|H|longer than prescribed. Your condition will not improve any||
8274|084|H|faster, and your risk of side effects will increase.||
8274|085|H|   Keep taking this medication even if you feel well. Do not stop||
8274|086|H|taking this medication without consulting your doctor. Some||
8274|087|H|conditions may become worse when this drug is suddenly stopped.||
8274|088|H|Also, you may experience symptoms such as trouble sleeping,||
8274|089|H|nausea, headache, diarrhea, irritability. Your dose may need to||
8274|090|H|be gradually decreased to reduce side effects. Report any new or||
8274|091|H|worsening symptoms right away.||
8274|092|H|   Tell your doctor if your condition lasts or gets worse.||
8274|093|B|||
8274|094|S|SIDE EFFECTS:  See also Warning section.||
8274|095|S|   Constipation, drowsiness, upset stomach, tiredness, weight||
8274|096|S|gain, blurred vision, or dry mouth may occur. If any of these||
8274|097|S|effects last or get worse, tell your doctor promptly.||
8274|098|S|   Dizziness or lightheadedness may occur, especially when you||
8274|099|S|first start or increase your dose of this drug. Dizziness and||
8274|100|S|lightheadedness can increase the risk of falling. Get up slowly||
8274|101|S|when rising from a sitting or lying position.||
8274|102|S|   Remember that this medication has been prescribed because your||
8274|103|S|doctor has judged that the benefit to you is greater than the||
8274|104|S|risk of side effects. Many people using this medication do not||
8274|105|S|have serious side effects.||
8274|106|S|   Tell your doctor right away if you have any serious side||
8274|107|S|effects, including: constipation with abdominal pain that doesn't||
8274|108|S|go away, nausea/vomiting that doesn't stop, restlessness/constant||
8274|109|S|need to move, shakiness (tremor), mental/mood changes (such as||
8274|110|S|increased anxiety, depression, thoughts of suicide), difficulty||
8274|111|S|swallowing, loss of appetite, yellowing eyes/skin, interrupted||
8274|112|S|breathing during sleep, trouble urinating.||
8274|113|S|   Get medical help right away if you have any very serious side||
8274|114|S|effects, including: fainting, seizure, severe dizziness.||
8274|115|S|   This medication may rarely make your blood sugar rise, which||
8274|116|S|can cause or worsen diabetes. Tell your doctor right away if you||
8274|117|S|have symptoms of high blood sugar such as increased||
8274|118|S|thirst/urination. If you already have diabetes, check your blood||
8274|119|S|sugar regularly as directed and share the results with your||
8274|120|S|doctor. Your doctor may need to adjust your diabetes medication,||
8274|121|S|exercise program, or diet.||
8274|122|S|   This drug may also cause significant weight gain and a rise in||
8274|123|S|your blood cholesterol (or triglyceride) levels. These effects,||
8274|124|S|along with diabetes, may increase your risk for developing heart||
8274|125|S|disease. Discuss the risks and benefits of treatment with your||
8274|126|S|doctor. (See also Notes section.)||
8274|127|S|   Quetiapine may rarely cause a condition known as tardive||
8274|128|S|dyskinesia. In some cases, this condition may be permanent. Tell||
8274|129|S|your doctor right away if you develop any unusual/uncontrolled||
8274|130|S|movements (especially of the face, lips, mouth, tongue, arms or||
8274|131|S|legs).||
8274|132|S|   This medication may rarely cause a very serious condition||
8274|133|S|called neuroleptic malignant syndrome (NMS). Get medical help||
8274|134|S|right away if you have any of the following symptoms: fever,||
8274|135|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
8274|136|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
8274|137|S|signs of kidney problems (such as change in the amount of urine).||
8274|138|S|   Quetiapine may increase a certain natural substance||
8274|139|S|(prolactin) made by your body. For females, this increase in||
8274|140|S|prolactin may result in unwanted breast milk, missed/stopped||
8274|141|S|periods, or difficulty becoming pregnant. For males, it may||
8274|142|S|result in decreased sexual ability, inability to produce sperm,||
8274|143|S|or enlarged breasts. If you develop any of these symptoms, tell||
8274|144|S|your doctor right away.||
8274|145|S|   Rarely, males may have a painful or prolonged erection lasting||
8274|146|S|4 or more hours. If this occurs, stop using this drug and get||
8274|147|S|medical help right away, or permanent problems could occur.||
8274|148|S|   A very serious allergic reaction to this drug is rare.||
8274|149|S|However, get medical help right away if you notice any symptoms||
8274|150|S|of a serious allergic reaction, including: fever, swollen lymph||
8274|151|S|nodes, rash, itching/swelling (especially of the||
8274|152|S|face/tongue/throat), severe dizziness, trouble breathing.||
8274|153|S|   This is not a complete list of possible side effects. If you||
8274|154|S|notice other effects not listed above, contact your doctor or||
8274|155|S|pharmacist.||
8274|156|S|   In the US -||
8274|157|S|   Call your doctor for medical advice about side effects. You||
8274|158|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8274|159|S|www.fda.gov/medwatch.||
8274|160|S|   In Canada - Call your doctor for medical advice about side||
8274|161|S|effects. You may report side effects to Health Canada at||
8274|162|S|1-866-234-2345.||
8274|163|B|||
8274|164|P|PRECAUTIONS:  Before taking quetiapine, tell your doctor or||
8274|165|P|pharmacist if you are allergic to it; or if you have any other||
8274|166|P|allergies. This product may contain inactive ingredients, which||
8274|167|P|can cause allergic reactions or other problems. Talk to your||
8274|168|P|pharmacist for more details.||
8274|169|P|   Before using this medication, tell your doctor or pharmacist||
8274|170|P|your medical history, especially of: eye cataracts, liver||
8274|171|P|disease, low white blood cell count (including history of low||
8274|172|P|white blood cell count caused by medications), seizure disorder,||
8274|173|P|trouble swallowing, thyroid problems, stomach/intestinal blockage||
8274|174|P|(such as severe constipation, bowel obstruction),||
8274|175|P|stomach/intestines that are not moving (such as ileus), personal||
8274|176|P|or family history of diabetes, personal or family history of a||
8274|177|P|substance use disorder (such as overuse of or addiction to||
8274|178|P|drugs/alcohol), heart disease, high blood pressure, high||
8274|179|P|cholesterol/triglyceride levels, breathing trouble during sleep||
8274|180|P|(sleep apnea), difficulty urinating (for example, due to enlarged||
8274|181|P|prostate).||
8274|182|P|   This drug may make you dizzy or drowsy or blur your vision.||
8274|183|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8274|184|P|drowsy. Do not drive, use machinery, or do anything that needs||
8274|185|P|alertness or clear vision until you can do it safely. Avoid||
8274|186|P|alcoholic beverages. Talk to your doctor if you are using||
8274|187|P|marijuana (cannabis).||
8274|188|P|   Quetiapine may cause a condition that affects the heart rhythm||
8274|189|P|(QT prolongation). QT prolongation can rarely cause serious||
8274|190|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
8274|191|P|as severe dizziness, fainting) that need medical attention right||
8274|192|P|away.||
8274|193|P|   The risk of QT prolongation may be increased if you have||
8274|194|P|certain medical conditions or are taking other drugs that may||
8274|195|P|cause QT prolongation. Before using quetiapine, tell your doctor||
8274|196|P|or pharmacist of all the drugs you take and if you have any of||
8274|197|P|the following conditions: certain heart problems (heart failure,||
8274|198|P|slow heartbeat, QT prolongation in the EKG), family history of||
8274|199|P|certain heart problems (QT prolongation in the EKG, sudden||
8274|200|P|cardiac death).||
8274|201|P|   Low levels of potassium or magnesium in the blood may also||
8274|202|P|increase your risk of QT prolongation. This risk may increase if||
8274|203|P|you use certain drugs (such as diuretics/"water pills") or if you||
8274|204|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8274|205|P|Talk to your doctor about using quetiapine safely.||
8274|206|P|   This medication may make you sweat less, making you more||
8274|207|P|likely to get heat stroke. Avoid doing things that may cause you||
8274|208|P|to overheat, such as hard work or exercise in hot weather, or||
8274|209|P|using hot tubs. When the weather is hot, drink a lot of fluids||
8274|210|P|and dress lightly. If you overheat, quickly look for a place to||
8274|211|P|cool down and rest. Get medical help right away if you have a||
8274|212|P|fever that does not go away, mental/mood changes, headache, or||
8274|213|P|dizziness.||
8274|214|P|   Before having surgery, tell your doctor or dentist about all||
8274|215|P|the products you use (including prescription drugs,||
8274|216|P|nonprescription drugs, and herbal products).||
8274|217|P|   Children may be at higher risk for certain side effects while||
8274|218|P|taking this medication, such as increased blood pressure or||
8274|219|P|increased prolactin (see also Side Effects section). Talk with||
8274|220|P|the doctor about the risks and benefits.||
8274|221|P|   Older adults may be more sensitive to the side effects of this||
8274|222|P|drug, especially drowsiness, dizziness, lightheadedness, and QT||
8274|223|P|prolongation (see above). Drowsiness, dizziness, and||
8274|224|P|lightheadedness can increase the risk of falling.||
8274|225|P|   During pregnancy, this medication should be used only when||
8274|226|P|clearly needed. Babies born to mothers who have used this drug||
8274|227|P|during the last 3 months of pregnancy may rarely develop symptoms||
8274|228|P|including muscle stiffness or shakiness, drowsiness,||
8274|229|P|feeding/breathing difficulties, or constant crying. If you notice||
8274|230|P|any of these symptoms in your newborn especially during their||
8274|231|P|first month, tell the doctor right away.||
8274|232|P|   Since untreated mental/mood problems (such as schizophrenia,||
8274|233|P|bipolar disorder, depression) can be a serious condition, do not||
8274|234|P|stop taking this medication unless directed by your doctor. If||
8274|235|P|you are planning pregnancy, become pregnant, or think you may be||
8274|236|P|pregnant, immediately discuss with your doctor the benefits and||
8274|237|P|risks of using this medication during pregnancy.||
8274|238|P|   This medication passes into breast milk and may have||
8274|239|P|undesirable effects on a nursing infant. Tell the doctor right||
8274|240|P|away if your baby develops symptoms such as muscle stiffness or||
8274|241|P|shakiness, unusual sleepiness, or difficulty feeding. Consult||
8274|242|P|your doctor before breastfeeding.||
8274|243|B|||
8274|244|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8274|245|I|medications work or increase your risk for serious side effects.||
8274|246|I|This document does not contain all possible drug interactions.||
8274|247|I|Keep a list of all the products you use (including||
8274|248|I|prescription/nonprescription drugs and herbal products) and share||
8274|249|I|it with your doctor and pharmacist. Do not start, stop, or change||
8274|250|I|the dosage of any medicines without your doctor's approval.||
8274|251|I|   Many drugs besides quetiapine may affect the heart rhythm (QT||
8274|252|I|prolongation), including amiodarone, moxifloxacin, procainamide,||
8274|253|I|quinidine, sotalol, thioridazine, among others.||
8274|254|I|   Other medications can affect the removal of quetiapine from||
8274|255|I|your body, which may affect how quetiapine works. Examples||
8274|256|I|include azole antifungals (such as itraconazole, ketoconazole),||
8274|257|I|drugs used to treat seizures (such as phenytoin), among others.||
8274|258|I|   Tell your doctor or pharmacist if you are taking other||
8274|259|I|products that cause drowsiness such as opioid pain or cough||
8274|260|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8274|261|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
8274|262|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
8274|263|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8274|264|I|diphenhydramine).||
8274|265|I|   Check the labels on all your medicines (such as allergy or||
8274|266|I|cough-and-cold products) because they may contain ingredients||
8274|267|I|that cause drowsiness. Ask your pharmacist about using those||
8274|268|I|products safely.||
8274|269|I|   This medication may interfere with certain lab tests (such as||
8274|270|I|urine tests), possibly causing false test results. Make sure lab||
8274|271|I|personnel and all your doctors know you use this drug.||
8274|272|B|||
8274|273|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8274|274|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8274|275|O|poison control center right away. US residents can call||
8274|276|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8274|277|O|Symptoms of overdose may include: severe drowsiness, loss of||
8274|278|O|consciousness.||
8274|279|B|||
8274|280|N|NOTES:  Do not share this medication with others.||
8274|281|N|   Lab and/or medical tests (such as blood sugar, blood pressure,||
8274|282|N|cholesterol levels, eye exams, weight, blood counts) should be||
8274|283|N|done before you start taking this medication and while you are||
8274|284|N|taking it. Keep all medical and lab appointments. Consult your||
8274|285|N|doctor for more details.||
8274|286|B|||
8274|287|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8274|288|D|remember. If it is near the time of the next dose, skip the||
8274|289|D|missed dose. Take your next dose at the regular time. Do not||
8274|290|D|double the dose to catch up.||
8274|291|B|||
8274|292|R|STORAGE:  Store at room temperature away from light and moisture.||
8274|293|R|Do not store in the bathroom. Keep all medications away from||
8274|294|R|children and pets.||
8274|295|R|   Do not flush medications down the toilet or pour them into a||
8274|296|R|drain unless instructed to do so. Properly discard this product||
8274|297|R|when it is expired or no longer needed. Consult your pharmacist||
8274|298|R|or local waste disposal company.||
8274|299|B|||
8274|300|A|Information last revised May 2024.||
8274|301|A|Copyright(c) 2025 First Databank, Inc.||
8274|302|B|||
8277|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8277|002|Z|does NOT have all possible information about this product. This||
8277|003|Z|information does not assure that this product is safe, effective,||
8277|004|Z|or appropriate for you. This information is not individual||
8277|005|Z|medical advice and does not substitute for the advice of your||
8277|006|Z|health care professional. Always ask your health care||
8277|007|Z|professional for complete information about this product and your||
8277|008|Z|specific health needs.||
8277|009|B|||
8277|010|T|MONTELUKAST - ORAL||
8277|011|F|(mon-teh-LEW-kast)||
8277|012|B|||
8277|013|C|COMMON BRAND NAME(S): Singulair||
8277|014|B|||
8277|015|W|WARNING:  This medication may rarely cause serious mental/mood||
8277|016|W|changes. These effects may occur even after the medication has||
8277|017|W|been stopped. Tell your doctor right away if you or a||
8277|018|W|caregiver/family member notice symptoms such as agitation,||
8277|019|W|anxiety, abnormal dreams, depression, memory/attention problems,||
8277|020|W|hallucinations, trouble sleeping, or changes in behavior (such as||
8277|021|W|aggression, hostility, restlessness, sleepwalking, suicidal||
8277|022|W|thoughts/attempts). Talk to your doctor about the risks and||
8277|023|W|benefits of this medication.||
8277|024|B|||
8277|025|U|USES:  Montelukast is used to control and prevent symptoms caused||
8277|026|U|by asthma (such as wheezing and shortness of breath). It is also||
8277|027|U|used before exercise to prevent breathing problems during||
8277|028|U|exercise (bronchospasm). This medication can help decrease the||
8277|029|U|number of times you need to use your quick relief inhaler.||
8277|030|U|   Montelukast is also used to relieve symptoms of hay fever and||
8277|031|U|allergic rhinitis (such as sneezing, stuffy/runny/itchy nose).||
8277|032|U|Since there are other allergy medications that may be safer (see||
8277|033|U|also Warning section), this medication should be used for this||
8277|034|U|condition only when you cannot take other allergy medications or||
8277|035|U|they do not work well.||
8277|036|U|   This medication must be used regularly to be effective. It||
8277|037|U|does not work right away and should not be used to relieve sudden||
8277|038|U|asthma attacks or breathing problems. If an asthma attack or||
8277|039|U|sudden shortness of breath occurs, use your quick-relief inhaler||
8277|040|U|as prescribed.||
8277|041|U|   This drug works by blocking certain natural substances||
8277|042|U|(leukotrienes) that may cause or worsen asthma and allergies. It||
8277|043|U|helps make breathing easier by reducing swelling (inflammation)||
8277|044|U|in the airways.||
8277|045|B|||
8277|046|H|HOW TO USE:  Read the Medication Guide provided by your||
8277|047|H|pharmacist before you start taking montelukast and each time you||
8277|048|H|get a refill. If you have any questions, ask your doctor or||
8277|049|H|pharmacist.||
8277|050|H|   Take this medication by mouth with or without food as directed||
8277|051|H|by your doctor. The dosage is based on your age and medical||
8277|052|H|condition.||
8277|053|H|   If you are using the chewable tablets, chew them thoroughly||
8277|054|H|before swallowing. If your child cannot safely chew and swallow||
8277|055|H|them, consult the doctor or pharmacist for advice.||
8277|056|H|   Take this medication at the same time each day. If you are||
8277|057|H|taking this medication for asthma or for both asthma and||
8277|058|H|allergies, take your dose in the evening. If you are taking||
8277|059|H|montelukast to prevent only allergies, take your dose either in||
8277|060|H|the morning or the evening.||
8277|061|H|   If you are taking this medication to prevent breathing||
8277|062|H|problems during exercise, take your dose at least 2 hours before||
8277|063|H|exercise. Do not take more than one dose in 24 hours. Do not take||
8277|064|H|a dose before exercise if you are already taking this medication||
8277|065|H|daily for asthma or allergies. Doing so may increase the risk of||
8277|066|H|side effects.||
8277|067|H|   Do not increase or decrease your dose or stop using this||
8277|068|H|medication without consulting your doctor. Continue to use this||
8277|069|H|medication regularly to keep your asthma under control, even||
8277|070|H|during sudden asthma attacks or periods when you have no asthma||
8277|071|H|symptoms. Continue to also take other medications for asthma as||
8277|072|H|directed by your doctor. This medication works over time and is||
8277|073|H|not meant to relieve sudden attacks of asthma. If an asthma||
8277|074|H|attack or other breathing problem occurs, use your quick-relief||
8277|075|H|inhaler as prescribed. You should always have a quick-relief||
8277|076|H|inhaler with you. Consult your doctor or pharmacist for more||
8277|077|H|details.||
8277|078|H|   Get medical help right away if your asthma symptoms get worse||
8277|079|H|and your quick-relief inhaler is not helping. Tell your doctor||
8277|080|H|promptly if asthma symptoms, breathing problems, allergy||
8277|081|H|symptoms, number of times you use your rescue inhaler last or get||
8277|082|H|worse.||
8277|083|B|||
8277|084|S|SIDE EFFECTS:  See also Warning section.||
8277|085|S|   Remember that this medication has been prescribed because your||
8277|086|S|doctor has judged that the benefit to you is greater than the||
8277|087|S|risk of side effects. Many people using this medication do not||
8277|088|S|have serious side effects.||
8277|089|S|   Tell your doctor right away if you have any serious side||
8277|090|S|effects, including: numbness/tingling/shooting pain in the arms||
8277|091|S|or legs, sinus pain/swelling, muscle weakness, uncontrolled||
8277|092|S|muscle movements, stuttering.||
8277|093|S|   A very serious allergic reaction to this drug is rare.||
8277|094|S|However, get medical help right away if you notice any symptoms||
8277|095|S|of a serious allergic reaction, including: rash, itching/swelling||
8277|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8277|097|S|breathing.||
8277|098|S|   This is not a complete list of possible side effects. If you||
8277|099|S|notice other effects not listed above, contact your doctor or||
8277|100|S|pharmacist.||
8277|101|S|   In the US -||
8277|102|S|   Call your doctor for medical advice about side effects. You||
8277|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8277|104|S|www.fda.gov/medwatch.||
8277|105|S|   In Canada - Call your doctor for medical advice about side||
8277|106|S|effects. You may report side effects to Health Canada at||
8277|107|S|1-866-234-2345.||
8277|108|B|||
8277|109|P|PRECAUTIONS:  Before taking montelukast, tell your doctor or||
8277|110|P|pharmacist if you are allergic to it; or if you have any other||
8277|111|P|allergies. This product may contain inactive ingredients, which||
8277|112|P|can cause allergic reactions or other problems. Talk to your||
8277|113|P|pharmacist for more details.||
8277|114|P|   Before using this drug, tell your doctor or pharmacist your||
8277|115|P|medical history, especially of: liver disease, mental/mood||
8277|116|P|problems (such as anxiety, depression, thoughts of suicide).||
8277|117|P|   Before having surgery, tell your doctor or dentist about all||
8277|118|P|the products you use (including prescription drugs,||
8277|119|P|nonprescription drugs, and herbal products).||
8277|120|P|   The chewable tablets may contain aspartame. If you have||
8277|121|P|phenylketonuria (PKU) or any other condition that requires you to||
8277|122|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
8277|123|P|doctor or pharmacist about using this medication safely.||
8277|124|P|   During pregnancy, this medication should be used only when||
8277|125|P|clearly needed. Discuss the risks and benefits with your doctor.||
8277|126|P|   This medication passes into breast milk. Consult your doctor||
8277|127|P|before breastfeeding.||
8277|128|B|||
8277|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8277|130|I|medications work or increase your risk for serious side effects.||
8277|131|I|This document does not contain all possible drug interactions.||
8277|132|I|Keep a list of all the products you use (including||
8277|133|I|prescription/nonprescription drugs and herbal products) and share||
8277|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
8277|135|I|the dosage of any medicines without your doctor's approval.||
8277|136|B|||
8277|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8277|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8277|139|O|poison control center right away. US residents can call||
8277|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8277|141|O|Symptoms of overdose may include: thirst, drowsiness, inability||
8277|142|O|to keep still, vomiting, or severe stomach pain.||
8277|143|B|||
8277|144|N|NOTES:  Do not share this medication with others.||
8277|145|N|   Lab and/or medical tests (such as lung function) should be||
8277|146|N|done while you are taking this medication. Keep all medical and||
8277|147|N|lab appointments. Consult your doctor for more details.||
8277|148|B|||
8277|149|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
8277|150|D|next dose at the regular time. Do not double the dose to catch||
8277|151|D|up. Do not take more than 1 dose in 24 hours.||
8277|152|B|||
8277|153|R|STORAGE:  Store at room temperature away from light and moisture.||
8277|154|R|Do not store in the bathroom. Keep all medications away from||
8277|155|R|children and pets.||
8277|156|R|   Do not flush medications down the toilet or pour them into a||
8277|157|R|drain unless instructed to do so. Properly discard this product||
8277|158|R|when it is expired or no longer needed. Consult your pharmacist||
8277|159|R|or local waste disposal company.||
8277|160|B|||
8277|161|M|MEDICAL ALERT:  Your condition can cause complications in a||
8277|162|M|medical emergency. For information about enrolling in MedicAlert,||
8277|163|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8277|164|B|||
8277|165|A|Information last revised November 2024.||
8277|166|A|Copyright(c) 2025 First Databank, Inc.||
8277|167|B|||
8278|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8278|002|Z|does NOT have all possible information about this product. This||
8278|003|Z|information does not assure that this product is safe, effective,||
8278|004|Z|or appropriate for you. This information is not individual||
8278|005|Z|medical advice and does not substitute for the advice of your||
8278|006|Z|health care professional. Always ask your health care||
8278|007|Z|professional for complete information about this product and your||
8278|008|Z|specific health needs.||
8278|009|B|||
8278|010|T|HYDROCODONE/IBUPROFEN - ORAL||
8278|011|F|(HYE-droe-KOE-done/EYE-bue-proe-fen)||
8278|012|B|||
8278|013|C|COMMON BRAND NAME(S): Vicoprofen||
8278|014|B|||
8278|015|W|WARNING:  Hydrocodone/ibuprofen has a risk for abuse and||
8278|016|W|addiction, which can lead to overdose and death.||
8278|017|W|Hydrocodone/ibuprofen may also cause severe, possibly fatal,||
8278|018|W|breathing problems. To lower your risk, your doctor should have||
8278|019|W|you take the smallest dose of hydrocodone/ibuprofen that works,||
8278|020|W|and take it for the shortest possible time. See also How to Use||
8278|021|W|section for more information about addiction.||
8278|022|W|   Ask your doctor or pharmacist if you should have medication||
8278|023|W|available to treat opioid overdose (such as naloxone, nalmefene).||
8278|024|W|Teach your family or household members about the signs of an||
8278|025|W|opioid overdose and how to treat it.||
8278|026|W|   The risk for severe breathing problems is higher when you||
8278|027|W|start this medication and after a dose increase, or if you take||
8278|028|W|the wrong dose/strength. Taking this medication with alcohol or||
8278|029|W|other drugs that can cause drowsiness or breathing problems may||
8278|030|W|cause very serious side effects, including death. Also, other||
8278|031|W|medications can affect the removal of hydrocodone/ibuprofen from||
8278|032|W|your body, which may affect how hydrocodone/ibuprofen works. Be||
8278|033|W|sure you know how to take hydrocodone/ibuprofen and what other||
8278|034|W|drugs you should avoid taking with it. See also Drug Interactions||
8278|035|W|section. Get medical help right away if any of these very serious||
8278|036|W|side effects occur: slow/shallow breathing, unusual||
8278|037|W|lightheadedness, severe drowsiness/dizziness, difficulty waking||
8278|038|W|up.||
8278|039|W|   Keep this medicine in a safe place to prevent theft, misuse,||
8278|040|W|or abuse. If someone accidentally swallows this drug, get medical||
8278|041|W|help right away.||
8278|042|W|   The other ingredient in this medication, ibuprofen, may rarely||
8278|043|W|cause serious (rarely fatal) bleeding from the stomach or||
8278|044|W|intestines. Also, nonsteroidal anti-inflammatory drugs (including||
8278|045|W|ibuprofen) may rarely increase the risk for a heart attack or||
8278|046|W|stroke. This effect can happen at any time while taking this drug||
8278|047|W|but is more likely if you take it for a long time. The risk may||
8278|048|W|be greater in older adults or if you have heart disease or||
8278|049|W|increased risk for heart disease (for example, due to smoking,||
8278|050|W|family history of heart disease, or conditions such as high blood||
8278|051|W|pressure or diabetes). Do not take this drug right before or||
8278|052|W|after heart bypass surgery (CABG). Talk to your doctor or||
8278|053|W|pharmacist about the benefits and risks of treatment, as well as||
8278|054|W|other possible medication choices.||
8278|055|W|   Stop taking this medication and get medical help right away if||
8278|056|W|you notice any of the following rare but very serious side||
8278|057|W|effects: stomach/abdominal pain that doesn't go away, chest pain,||
8278|058|W|severe dizziness, weakness on one side of the body, vision||
8278|059|W|changes, trouble speaking, black stools, vomit that looks like||
8278|060|W|coffee grounds. (See also Precautions section.)||
8278|061|W|   Before using this medication, women of childbearing age should||
8278|062|W|talk with their doctor(s) about the benefits and risks. Tell your||
8278|063|W|doctor if you are pregnant or if you plan to become pregnant.||
8278|064|W|This medication may harm an unborn baby and cause problems with||
8278|065|W|normal labor/delivery. It is not recommended for use in pregnancy||
8278|066|W|from 20 weeks until delivery. If your doctor decides that you||
8278|067|W|need to use this medication between 20 and 30 weeks of pregnancy,||
8278|068|W|you should use the lowest effective dose for the shortest||
8278|069|W|possible time. You should not use this medication after 30 weeks||
8278|070|W|of pregnancy. Babies born to mothers who use this drug for a long||
8278|071|W|time may develop severe (possibly fatal) withdrawal symptoms.||
8278|072|W|Tell the doctor right away if you notice any symptoms in your||
8278|073|W|newborn baby such as crying that doesn't stop, slow/shallow||
8278|074|W|breathing, irritability, shaking, vomiting, diarrhea, poor||
8278|075|W|feeding, or difficulty gaining weight.||
8278|076|B|||
8278|077|U|USES:  This combination medication is used for a short time||
8278|078|U|(usually less than 10 days) to help relieve moderate to severe||
8278|079|U|pain. It contains an opioid pain reliever (hydrocodone) and a||
8278|080|U|nonsteroidal anti-inflammatory drug-NSAID (ibuprofen).||
8278|081|U|Hydrocodone works in the brain to change how your body feels and||
8278|082|U|responds to pain. Ibuprofen reduces pain and fever.||
8278|083|U|   This medication is not intended to treat long-term conditions||
8278|084|U|(such as arthritis).||
8278|085|B|||
8278|086|H|HOW TO USE:  Read the Medication Guide provided by your||
8278|087|H|pharmacist before you start using this medication and each time||
8278|088|H|you get a refill. If you have any questions, ask your doctor or||
8278|089|H|pharmacist.||
8278|090|H|   Take this medication by mouth as directed by your doctor,||
8278|091|H|usually every 4 to 6 hours as needed. Take it with a full glass||
8278|092|H|of water (8 ounces or 240 milliliters) unless your doctor directs||
8278|093|H|you otherwise. Do not lie down for at least 10 minutes after||
8278|094|H|taking this drug. You may take this drug with or without food. If||
8278|095|H|you have nausea, it may help to take this drug with food. Ask||
8278|096|H|your doctor or pharmacist about other ways to decrease nausea||
8278|097|H|(such as lying down for 1 to 2 hours with as little head movement||
8278|098|H|as possible).||
8278|099|H|   The dosage is based on your medical condition and response to||
8278|100|H|treatment. To reduce your risk of stomach bleeding and other side||
8278|101|H|effects, take this medication at the lowest effective dose for||
8278|102|H|the shortest possible time. Do not increase your dose, take the||
8278|103|H|medication more often, or take it for a longer time than||
8278|104|H|prescribed. Properly stop the medication when so directed. The||
8278|105|H|manufacturer recommends you take no more than 5 tablets in a||
8278|106|H|24-hour period.||
8278|107|H|   Pain medications work best if they are used as the first signs||
8278|108|H|of pain occur. If you wait until the pain has worsened, the||
8278|109|H|medication may not work as well. Also follow your doctor's or||
8278|110|H|pharmacist's directions for the safe use of other non-opioid pain||
8278|111|H|relievers (such as acetaminophen).||
8278|112|H|   Suddenly stopping this medication may cause withdrawal,||
8278|113|H|especially if you have used it for a long time or in high doses.||
8278|114|H|To prevent withdrawal, your doctor may lower your dose slowly.||
8278|115|H|Tell your doctor or pharmacist right away if you have any||
8278|116|H|withdrawal symptoms such as restlessness, mental/mood changes||
8278|117|H|(including anxiety, trouble sleeping, thoughts of suicide),||
8278|118|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
8278|119|H|aches, or sudden changes in behavior.||
8278|120|H|   When this medication is used for a long time, it may not work||
8278|121|H|as well. Talk with your doctor if this medication stops working||
8278|122|H|well.||
8278|123|H|   Though it helps many people, this medication may sometimes||
8278|124|H|cause addiction. This risk may be higher if you have a||
8278|125|H|mental/mood disorder or a substance use disorder (such as overuse||
8278|126|H|of or addiction to drugs/alcohol). Take this medication exactly||
8278|127|H|as prescribed to lower the risk of addiction. Ask your doctor or||
8278|128|H|pharmacist for more details.||
8278|129|H|   Tell your doctor if your pain does not get better or if it||
8278|130|H|gets worse, or if you have any new pain.||
8278|131|B|||
8278|132|S|SIDE EFFECTS:  See also Warning section.||
8278|133|S|   Upset stomach, nausea, vomiting, constipation, dizziness,||
8278|134|S|lightheadedness, or drowsiness may occur. If any of these effects||
8278|135|S|last or get worse, tell your doctor or pharmacist promptly.||
8278|136|S|   To prevent constipation, eat dietary fiber, drink enough||
8278|137|S|water, and exercise. You may also need to take a laxative. Ask||
8278|138|S|your pharmacist which type of laxative is right for you.||
8278|139|S|   To reduce the risk of dizziness and lightheadedness, get up||
8278|140|S|slowly when rising from a sitting or lying position.||
8278|141|S|   Remember that this medication has been prescribed because your||
8278|142|S|doctor has judged that the benefit to you is greater than the||
8278|143|S|risk of side effects. Many people using this medication do not||
8278|144|S|have serious side effects.||
8278|145|S|   Tell your doctor right away if you have any serious side||
8278|146|S|effects, including: easy bruising/bleeding, fast/pounding||
8278|147|S|heartbeat, difficult/painful swallowing, interrupted breathing||
8278|148|S|during sleep (sleep apnea), mental/mood changes (such as||
8278|149|S|agitation, confusion, hallucinations), difficulty urinating,||
8278|150|S|unusual weakness, signs of your adrenal glands not working well||
8278|151|S|(such as loss of appetite, unusual tiredness, weight loss),||
8278|152|S|unexplained stiff neck, signs of kidney problems (such as change||
8278|153|S|in the amount of urine), symptoms of heart failure (such as||
8278|154|S|swelling ankles/feet, unusual/sudden weight gain).||
8278|155|S|   Stop taking this medication and get medical help right away if||
8278|156|S|any of these very serious side effects occur: fainting,||
8278|157|S|slow/irregular/shallow breathing, severe drowsiness/difficulty||
8278|158|S|waking up, unexplained fever, seizure.||
8278|159|S|   This drug may rarely cause serious, possibly fatal, liver||
8278|160|S|disease. Stop taking this medication and get medical help right||
8278|161|S|away if you have any symptoms of liver damage, including:||
8278|162|S|nausea/vomiting that doesn't stop, dark urine, stomach/abdominal||
8278|163|S|pain, yellowing eyes/skin.||
8278|164|S|   A very serious allergic reaction to this drug is rare.||
8278|165|S|However, get medical help right away if you notice any symptoms||
8278|166|S|of a serious allergic reaction, including: fever, swollen lymph||
8278|167|S|nodes, rash/blisters, itching/swelling (especially of the||
8278|168|S|face/tongue/throat), severe dizziness, trouble breathing.||
8278|169|S|   This is not a complete list of possible side effects. If you||
8278|170|S|notice other effects not listed above, contact your doctor or||
8278|171|S|pharmacist.||
8278|172|S|   In the US -||
8278|173|S|   Call your doctor for medical advice about side effects. You||
8278|174|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8278|175|S|www.fda.gov/medwatch.||
8278|176|S|   In Canada - Call your doctor for medical advice about side||
8278|177|S|effects. You may report side effects to Health Canada at||
8278|178|S|1-866-234-2345.||
8278|179|B|||
8278|180|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
8278|181|P|pharmacist if you are allergic to ibuprofen or hydrocodone; or to||
8278|182|P|aspirin or other NSAIDs (such as naproxen, celecoxib); or to||
8278|183|P|other opioids (such as benzhydrocodone, codeine, morphine,||
8278|184|P|hydromorphone); or if you have any other allergies. This product||
8278|185|P|may contain inactive ingredients, which can cause allergic||
8278|186|P|reactions or other problems. Talk to your pharmacist for more||
8278|187|P|details.||
8278|188|P|   Before using this medication, tell your doctor or pharmacist||
8278|189|P|your medical history, especially of: asthma (including a history||
8278|190|P|of worsening breathing after taking aspirin or other NSAIDs), low||
8278|191|P|red blood cell count (anemia), bleeding or clotting problem,||
8278|192|P|brain disorders (such as head injury, tumor, seizures, stroke),||
8278|193|P|breathing problems (such as asthma, sleep apnea, chronic||
8278|194|P|obstructive pulmonary disease-COPD), growths in the nose (nasal||
8278|195|P|polyps), high blood pressure, heart problems (such as irregular||
8278|196|P|heartbeat, recent heart attack), liver disease, mental/mood||
8278|197|P|disorders (such as confusion, depression, thoughts of suicide),||
8278|198|P|personal or family history of a substance use disorder (such as||
8278|199|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
8278|200|P|problems (such as ulcer, blockage, constipation, diarrhea due to||
8278|201|P|infection, paralytic ileus), fluid retention/swelling of the||
8278|202|P|ankles/feet/hands, difficulty urinating (such as due to enlarged||
8278|203|P|prostate), gallbladder disease, disease of the pancreas||
8278|204|P|(pancreatitis).||
8278|205|P|   Kidney problems can sometimes occur with the use of NSAID||
8278|206|P|medications, including ibuprofen. Problems are more likely to||
8278|207|P|occur if you are dehydrated, have heart failure or kidney||
8278|208|P|disease, are an older adult, or if you take certain medications||
8278|209|P|(see also Drug Interactions section). Drink plenty of fluids as||
8278|210|P|directed by your doctor to prevent dehydration and tell your||
8278|211|P|doctor right away if you have a change in the amount of urine.||
8278|212|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8278|213|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8278|214|P|machinery, or do anything that needs alertness until you can do||
8278|215|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
8278|216|P|are using marijuana (cannabis).||
8278|217|P|   Before having surgery, tell your doctor or dentist about all||
8278|218|P|the products you use (including prescription drugs,||
8278|219|P|nonprescription drugs, and herbal products).||
8278|220|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
8278|221|P|and tobacco, especially when combined with this medicine, may||
8278|222|P|increase your risk for stomach bleeding. Avoid alcohol and stop||
8278|223|P|smoking. Consult your doctor or pharmacist for more information.||
8278|224|P|   Older adults may be at greater risk for dizziness, drowsiness,||
8278|225|P|confusion, stomach/intestinal bleeding, kidney problems, heart||
8278|226|P|attack, stroke, and slow/shallow breathing while using this drug.||
8278|227|P|   Children may be more sensitive to the side effects of this||
8278|228|P|drug, especially slow/shallow breathing.||
8278|229|P|   During pregnancy, this medication should be used only when||
8278|230|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
8278|231|P|benefits with your doctor. (See also Warning section.)||
8278|232|P|   This drug passes into breast milk and may have undesirable||
8278|233|P|effects on a nursing infant. Tell the doctor right away if your||
8278|234|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
8278|235|P|breathing. Consult your doctor before breastfeeding.||
8278|236|B|||
8278|237|I|DRUG INTERACTIONS:  See also Warning section.||
8278|238|I|   Drug interactions may change how your medications work or||
8278|239|I|increase your risk for serious side effects. This document does||
8278|240|I|not contain all possible drug interactions. Keep a list of all||
8278|241|I|the products you use (including prescription/nonprescription||
8278|242|I|drugs and herbal products) and share it with your doctor and||
8278|243|I|pharmacist. Do not start, stop, or change the dosage of any||
8278|244|I|medicines without your doctor's approval.||
8278|245|I|   Some products that may interact with this drug include:||
8278|246|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
8278|247|I|angiotensin II receptor blockers (such as losartan, valsartan),||
8278|248|I|certain pain medications (mixed opioid agonist-antagonists such||
8278|249|I|as butorphanol, nalbuphine, pentazocine), corticosteroids (such||
8278|250|I|as prednisone), lithium, naltrexone, pemetrexed, probenecid,||
8278|251|I|samidorphan.||
8278|252|I|   This medication may increase the risk of bleeding when taken||
8278|253|I|with other drugs that also may cause bleeding. Examples include||
8278|254|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
8278|255|I|dabigatran/enoxaparin/warfarin, among others.||
8278|256|I|   Other medications can affect the removal of||
8278|257|I|hydrocodone/ibuprofen from your body, which may affect how||
8278|258|I|hydrocodone/ibuprofen works. Examples include azole antifungals||
8278|259|I|(such as ketoconazole), macrolide antibiotics (such as||
8278|260|I|erythromycin), mifepristone, HIV medications (such as||
8278|261|I|tipranavir), rifamycins (such as rifabutin, rifampin), ritonavir,||
8278|262|I|certain drugs used to treat seizures (such as carbamazepine,||
8278|263|I|phenytoin), among others.||
8278|264|I|   Check all prescription and nonprescription medicine labels||
8278|265|I|carefully since many medications contain pain relievers/fever||
8278|266|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
8278|267|I|or naproxen). These drugs are similar to ibuprofen and may||
8278|268|I|increase your risk of side effects if taken together. However, if||
8278|269|I|your doctor has told you to take low-dose aspirin to prevent||
8278|270|I|heart attack or stroke (usually 81-162 milligrams a day), you||
8278|271|I|should keep taking the aspirin unless your doctor tells you not||
8278|272|I|to.||
8278|273|I|   Daily use of ibuprofen may decrease aspirin's ability to||
8278|274|I|prevent heart attack/stroke. Talk to your doctor about using a||
8278|275|I|different medication (such as acetaminophen) to treat pain. If||
8278|276|I|you must take ibuprofen, talk to your doctor about taking||
8278|277|I|immediate-release aspirin (not enteric-coated/EC) while taking||
8278|278|I|ibuprofen. Take this product at least 8 hours before or at least||
8278|279|I|2 hours after your aspirin dose. Do not increase your daily dose||
8278|280|I|of aspirin or change the way you take aspirin/other medications||
8278|281|I|without your doctor's approval.||
8278|282|I|   The risk of serious side effects (such as slow/shallow||
8278|283|I|breathing, severe drowsiness/dizziness) may be increased if this||
8278|284|I|medication is taken with other products that may also cause||
8278|285|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
8278|286|I|if you are taking other products such as other opioid pain or||
8278|287|I|cough relievers (such as codeine, oxycodone), alcohol, marijuana||
8278|288|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
8278|289|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
8278|290|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8278|291|I|diphenhydramine).||
8278|292|I|   Check the labels on all your medicines (such as allergy or||
8278|293|I|cough-and-cold products) because they may contain ingredients||
8278|294|I|that cause drowsiness. Ask your pharmacist about using those||
8278|295|I|products safely.||
8278|296|I|   This medication may interfere with certain lab tests (such as||
8278|297|I|amylase/lipase levels), possibly causing false test results. Make||
8278|298|I|sure lab personnel and all your doctors know you use this drug.||
8278|299|B|||
8278|300|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8278|301|O|as passing out or trouble breathing, give them naloxone or||
8278|302|O|nalmefene if available, then call 911. If the person is awake and||
8278|303|O|has no symptoms, call a poison control center right away. US||
8278|304|O|residents can call 1-800-222-1222. Canada residents can call||
8278|305|O|1-844-764-7669. Symptoms of overdose may include: slow breathing,||
8278|306|O|fast/slow/irregular heartbeat, coma.||
8278|307|B|||
8278|308|N|NOTES:  Do not share this medication with others. Sharing it is||
8278|309|N|against the law.||
8278|310|N|   Lab and/or medical tests (such as kidney function) may be done||
8278|311|N|while you are taking this medication. Keep all medical and lab||
8278|312|N|appointments. Consult your doctor for more details.||
8278|313|N|   This medication has been prescribed for your current condition||
8278|314|N|only. Do not use it later for another condition unless told to do||
8278|315|N|so by your doctor. A different medication may be necessary in||
8278|316|N|that case.||
8278|317|B|||
8278|318|D|MISSED DOSE:  If you are taking this product on a regular||
8278|319|D|schedule and miss a dose, take it as soon as you remember. If it||
8278|320|D|is near the time of the next dose, skip the missed dose. Take||
8278|321|D|your next dose at the regular time. Do not double the dose to||
8278|322|D|catch up.||
8278|323|B|||
8278|324|R|STORAGE:  Store at room temperature away from light and moisture.||
8278|325|R|Do not store in the bathroom. Keep all medications away from||
8278|326|R|children and pets.||
8278|327|R|   Do not flush medications down the toilet or pour them into a||
8278|328|R|drain unless instructed to do so. Properly discard this product||
8278|329|R|when it is expired or no longer needed. For more details, read||
8278|330|R|the Medication Guide, or consult your pharmacist or local waste||
8278|331|R|disposal company.||
8278|332|B|||
8278|333|A|Information last revised November 2025.||
8278|334|A|Copyright(c) 2025 First Databank, Inc.||
8278|335|B|||
8280|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8280|002|Z|does NOT have all possible information about this product. This||
8280|003|Z|information does not assure that this product is safe, effective,||
8280|004|Z|or appropriate for you. This information is not individual||
8280|005|Z|medical advice and does not substitute for the advice of your||
8280|006|Z|health care professional. Always ask your health care||
8280|007|Z|professional for complete information about this product and your||
8280|008|Z|specific health needs.||
8280|009|B|||
8280|010|T|MULTIVITAMINS W/IRON (INCLUDES PRENATAL VITS) - ORAL LIQUIDS||
8280|011|B|||
8280|012|W|WARNING:  Accidental overdose of iron-containing products is a||
8280|013|W|leading cause of fatal poisoning in children younger than 6||
8280|014|W|years. Keep this product out of reach of children. If overdose||
8280|015|W|does occur, get medical help right away or call a poison control||
8280|016|W|center.||
8280|017|B|||
8280|018|U|USES:  This medication is a multivitamin product used to treat or||
8280|019|U|prevent vitamin deficiency due to poor diet, certain illnesses,||
8280|020|U|or during pregnancy. Vitamins are important building blocks of||
8280|021|U|the body and help keep you in good health.||
8280|022|B|||
8280|023|H|HOW TO USE:  Take this medication by mouth as directed. Follow||
8280|024|H|all directions on the product package, or take as directed by||
8280|025|H|your doctor. Do not take more than the recommended dosage. If you||
8280|026|H|have any questions, ask your doctor or pharmacist.||
8280|027|H|   Use a medication-measuring device to carefully measure the||
8280|028|H|prescribed dose. Do not use a household spoon.||
8280|029|H|   Some products are best taken on an empty stomach 1 hour before||
8280|030|H|or 2 hours after meals. If stomach upset occurs, you may take||
8280|031|H|this medication with food. Avoid taking antacids, dairy products,||
8280|032|H|tea, or coffee within 2 hours before or after this medication||
8280|033|H|because they will decrease its effectiveness.||
8280|034|B|||
8280|035|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
8280|036|S|occur. These effects are usually temporary and may disappear as||
8280|037|S|your body adjusts to this medication. If any of these effects||
8280|038|S|last or get worse, tell your doctor or pharmacist promptly.||
8280|039|S|   Iron may cause your stools to turn black, which is not||
8280|040|S|harmful.||
8280|041|S|   If your doctor has directed you to use this medication,||
8280|042|S|remember that your doctor has judged that the benefit to you is||
8280|043|S|greater than the risk of side effects. Many people using this||
8280|044|S|medication do not have serious side effects.||
8280|045|S|   A very serious allergic reaction to this drug is rare.||
8280|046|S|However, get medical help right away if you notice any symptoms||
8280|047|S|of a serious allergic reaction, including: rash, itching/swelling||
8280|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8280|049|S|breathing.||
8280|050|S|   This is not a complete list of possible side effects. If you||
8280|051|S|notice other effects not listed above, contact your doctor or||
8280|052|S|pharmacist.||
8280|053|S|   In the US -||
8280|054|S|   Call your doctor for medical advice about side effects. You||
8280|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8280|056|S|www.fda.gov/medwatch.||
8280|057|S|   In Canada - Call your doctor for medical advice about side||
8280|058|S|effects. You may report side effects to Health Canada at||
8280|059|S|1-866-234-2345.||
8280|060|B|||
8280|061|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
8280|062|P|pharmacist if you are allergic to it; or if you have any other||
8280|063|P|allergies. This product may contain inactive ingredients, which||
8280|064|P|can cause allergic reactions or other problems. Talk to your||
8280|065|P|pharmacist for more details.||
8280|066|P|   Before taking this medication, tell your doctor or pharmacist||
8280|067|P|your medical history, especially of: iron overload disorder (such||
8280|068|P|as hemochromatosis, hemosiderosis), use/abuse of alcohol, liver||
8280|069|P|problems, stomach/intestinal problems (such as ulcer, colitis),||
8280|070|P|vitamin B12 deficiency (pernicious anemia).||
8280|071|P|   Liquid preparations of this product may contain sugar and/or||
8280|072|P|alcohol. Caution is advised if you have diabetes, alcohol||
8280|073|P|dependence, or liver disease. Ask your doctor or pharmacist about||
8280|074|P|using this product safely.||
8280|075|P|   Before having surgery, tell your doctor or dentist about all||
8280|076|P|the products you use (including prescription drugs,||
8280|077|P|nonprescription drugs, and herbal products).||
8280|078|P|   Tell your doctor if you are pregnant before using this||
8280|079|P|medication.||
8280|080|P|   This medication passes into breast milk. Consult your doctor||
8280|081|P|before breastfeeding.||
8280|082|B|||
8280|083|I|DRUG INTERACTIONS:  See also How To Use section.||
8280|084|I|   Drug interactions may change how your medications work or||
8280|085|I|increase your risk for serious side effects. This document does||
8280|086|I|not contain all possible drug interactions. Keep a list of all||
8280|087|I|the products you use (including prescription/nonprescription||
8280|088|I|drugs and herbal products) and share it with your doctor and||
8280|089|I|pharmacist. Do not start, stop, or change the dosage of any||
8280|090|I|medicines without your doctor's approval.||
8280|091|I|   This product can decrease the absorption of certain drugs,||
8280|092|I|especially if you take them around the same time. These drugs||
8280|093|I|include bisphosphonates (such as alendronate), levodopa,||
8280|094|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
8280|095|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
8280|096|I|minocycline), thyroid medications (such as levothyroxine), among||
8280|097|I|others. Ask your doctor or pharmacist how long you should wait||
8280|098|I|between doses of this product and your other medications and to||
8280|099|I|find a dosing schedule that works for all your medications.||
8280|100|I|   This product may interfere with certain lab tests (such as||
8280|101|I|fecal occult blood test), possibly causing false test results.||
8280|102|I|Make sure lab personnel and all your doctors know you use this||
8280|103|I|product.||
8280|104|B|||
8280|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8280|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8280|107|O|poison control center right away. US residents can call||
8280|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8280|109|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
8280|110|O|diarrhea.||
8280|111|B|||
8280|112|N|NOTES:  If your doctor has prescribed this medication, do not||
8280|113|N|share it with others.||
8280|114|N|   Lab and/or medical tests (such as complete blood count,||
8280|115|N|vitamin B12 levels) may be done while you are taking this||
8280|116|N|product. Keep all medical and lab appointments. Consult your||
8280|117|N|doctor for more details.||
8280|118|N|   This medication is not a substitute for a proper diet. It is||
8280|119|N|important to maintain a well-balanced diet. Foods rich in iron||
8280|120|N|include red meats (especially liver), fish, beans, dried fruit,||
8280|121|N|and iron-fortified or enriched cereals and bread.||
8280|122|B|||
8280|123|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8280|124|D|remember. If it is near the time of the next dose, skip the||
8280|125|D|missed dose. Take your next dose at the regular time. Do not||
8280|126|D|double the dose to catch up.||
8280|127|B|||
8280|128|R|STORAGE:  Different brands of this medication have different||
8280|129|R|storage needs. Check the product package for instructions on how||
8280|130|R|to store your brand, or ask your pharmacist. Keep all medications||
8280|131|R|away from children and pets.||
8280|132|R|   Do not flush medications down the toilet or pour them into a||
8280|133|R|drain unless instructed to do so. Properly discard this product||
8280|134|R|when it is expired or no longer needed. Consult your pharmacist||
8280|135|R|or local waste disposal company.||
8280|136|B|||
8280|137|A|Information last revised October 2025.||
8280|138|A|Copyright(c) 2025 First Databank, Inc.||
8280|139|B|||
8282|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8282|002|Z|does NOT have all possible information about this product. This||
8282|003|Z|information does not assure that this product is safe, effective,||
8282|004|Z|or appropriate for you. This information is not individual||
8282|005|Z|medical advice and does not substitute for the advice of your||
8282|006|Z|health care professional. Always ask your health care||
8282|007|Z|professional for complete information about this product and your||
8282|008|Z|specific health needs.||
8282|009|B|||
8282|010|T|OLOPATADINE - OPHTHALMIC||
8282|011|F|(oh-low-PAT-uh-deen)||
8282|012|B|||
8282|013|C|COMMON BRAND NAME(S): Pataday, Patanol, Pazeo||
8282|014|B|||
8282|015|U|USES:  This medication is an antihistamine used to treat itching||
8282|016|U|and redness in the eyes due to allergies.||
8282|017|U|   This medication is not recommended for the treatment of eye||
8282|018|U|irritation due to wearing contact lenses.||
8282|019|B|||
8282|020|H|HOW TO USE:  If you are using the over-the-counter product to||
8282|021|H|self-treat, read and follow all directions on the product package||
8282|022|H|before using this medication. If you have any questions, consult||
8282|023|H|your pharmacist. If your doctor has prescribed this medication,||
8282|024|H|use it as directed.||
8282|025|H|   Use this medication in the affected eye(s) as directed by the||
8282|026|H|product package or by your doctor, usually once or twice a day.||
8282|027|H|   To apply eye drops, wash hands first. To avoid contamination,||
8282|028|H|do not touch the dropper tip or let it touch your eye or any||
8282|029|H|other surface.||
8282|030|H|   If you are wearing contact lenses, remove them before using||
8282|031|H|eye drops. Wait at least 10 minutes before replacing your contact||
8282|032|H|lenses. Tilt your head back, look upward, and pull down the lower||
8282|033|H|eyelid to make a pouch. Hold the dropper directly over your eye||
8282|034|H|and place one drop into the pouch. Look downward, gently close||
8282|035|H|your eyes, and place one finger at the corner of your eye (near||
8282|036|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
8282|037|H|opening your eyes. This will prevent the medication from draining||
8282|038|H|out. Try not to blink or rub your eye. If directed to use this||
8282|039|H|medication in both eyes, repeat these steps for your other eye.||
8282|040|H|Do not rinse the dropper. Replace the dropper cap after each use.||
8282|041|H|   If you are using another kind of eye medication (such as drops||
8282|042|H|or ointments), wait at least 5 minutes before applying other||
8282|043|H|medications. Use eye drops before eye ointments to allow the||
8282|044|H|drops to enter the eye.||
8282|045|H|   Wait several minutes for your vision to clear before driving||
8282|046|H|or operating machinery.||
8282|047|H|   Use this medication regularly to get the most benefit from it.||
8282|048|H|To help you remember, use it at the same time(s) each day.||
8282|049|H|   If your condition lasts or gets worse, or if you think you may||
8282|050|H|have a serious medical problem, get medical help right away.||
8282|051|B|||
8282|052|S|SIDE EFFECTS:  Headache, blurred vision,||
8282|053|S|burning/stinging/redness/dryness of the eye, eyelid swelling, or||
8282|054|S|a feeling as if something is in your eye may occur. If any of||
8282|055|S|these effects last or get worse, tell your doctor or pharmacist||
8282|056|S|promptly.||
8282|057|S|   If your doctor has directed you to use this medication,||
8282|058|S|remember that your doctor has judged that the benefit to you is||
8282|059|S|greater than the risk of side effects. Many people using this||
8282|060|S|medication do not have serious side effects.||
8282|061|S|   A very serious allergic reaction to this drug is rare.||
8282|062|S|However, get medical help right away if you notice any symptoms||
8282|063|S|of a serious allergic reaction, including: rash, itching/swelling||
8282|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8282|065|S|breathing.||
8282|066|S|   This is not a complete list of possible side effects. If you||
8282|067|S|notice other effects not listed above, contact your doctor or||
8282|068|S|pharmacist.||
8282|069|S|   In the US -||
8282|070|S|   Call your doctor for medical advice about side effects. You||
8282|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8282|072|S|www.fda.gov/medwatch.||
8282|073|S|   In Canada - Call your doctor for medical advice about side||
8282|074|S|effects. You may report side effects to Health Canada at||
8282|075|S|1-866-234-2345.||
8282|076|B|||
8282|077|P|PRECAUTIONS:  Before using olopatadine, tell your doctor or||
8282|078|P|pharmacist if you are allergic to it; or if you have any other||
8282|079|P|allergies. This product may contain inactive ingredients, which||
8282|080|P|can cause allergic reactions or other problems. Talk to your||
8282|081|P|pharmacist for more details.||
8282|082|P|   Before using this medication, tell your doctor or pharmacist||
8282|083|P|your medical history.||
8282|084|P|   After you apply this drug, your vision may become temporarily||
8282|085|P|blurred. Do not drive, use machinery, or do anything that needs||
8282|086|P|clear vision until you can do it safely.||
8282|087|P|   Before having surgery, tell your doctor or dentist about all||
8282|088|P|the products you use (including prescription drugs,||
8282|089|P|nonprescription drugs, and herbal products).||
8282|090|P|   During pregnancy, this medication should be used only when||
8282|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
8282|092|P|   It is unknown if this drug passes into breast milk. Consult||
8282|093|P|your doctor before breastfeeding.||
8282|094|B|||
8282|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8282|096|I|medications work or increase your risk for serious side effects.||
8282|097|I|This document does not contain all possible drug interactions.||
8282|098|I|Keep a list of all the products you use (including||
8282|099|I|prescription/nonprescription drugs and herbal products) and share||
8282|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
8282|101|I|the dosage of any medicines without your doctor's approval.||
8282|102|B|||
8282|103|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8282|104|O|has overdosed and has serious symptoms such as passing out or||
8282|105|O|trouble breathing, call 911. Otherwise, call a poison control||
8282|106|O|center right away. US residents can call 1-800-222-1222. Canada||
8282|107|O|residents can call 1-844-764-7669.||
8282|108|B|||
8282|109|N|NOTES:  Keep all medical and lab appointments.||
8282|110|B|||
8282|111|D|MISSED DOSE:  If you are using this product on a regular schedule||
8282|112|D|and miss a dose, use it as soon as you remember. If it is near||
8282|113|D|the time of the next dose, skip the missed dose. Use your next||
8282|114|D|dose at the regular time. Do not double the dose to catch up.||
8282|115|B|||
8282|116|R|STORAGE:  Different brands of this medication have different||
8282|117|R|storage needs. Check the product package for instructions on how||
8282|118|R|to store your brand, or ask your pharmacist. Keep all medications||
8282|119|R|away from children and pets.||
8282|120|R|   Do not flush medications down the toilet or pour them into a||
8282|121|R|drain unless instructed to do so. Properly discard this product||
8282|122|R|when it is expired or no longer needed. Consult your pharmacist||
8282|123|R|or local waste disposal company.||
8282|124|B|||
8282|125|A|Information last revised February 2025.||
8282|126|A|Copyright(c) 2025 First Databank, Inc.||
8282|127|B|||
8284|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8284|002|Z|does NOT have all possible information about this product. This||
8284|003|Z|information does not assure that this product is safe, effective,||
8284|004|Z|or appropriate for you. This information is not individual||
8284|005|Z|medical advice and does not substitute for the advice of your||
8284|006|Z|health care professional. Always ask your health care||
8284|007|Z|professional for complete information about this product and your||
8284|008|Z|specific health needs.||
8284|009|B|||
8284|010|T|COLESEVELAM - ORAL||
8284|011|F|(KOE-le-SEV-e-lam)||
8284|012|B|||
8284|013|C|COMMON BRAND NAME(S): Welchol||
8284|014|B|||
8284|015|U|USES:  This medication is used along with a proper diet and||
8284|016|U|exercise to lower cholesterol in people with high levels of||
8284|017|U|cholesterol in the blood. Lowering cholesterol decreases the risk||
8284|018|U|of heart disease and helps prevent strokes and heart attacks.||
8284|019|U|   Colesevelam is also used along with a proper diet and exercise||
8284|020|U|to lower high blood sugar in people with type 2 diabetes.||
8284|021|U|Controlling high blood sugar helps prevent kidney damage,||
8284|022|U|blindness, nerve problems, loss of limbs, and sexual function||
8284|023|U|problems. Proper control of diabetes may also lessen your risk of||
8284|024|U|a heart attack or stroke.||
8284|025|U|   Colesevelam belongs to a class of drugs called bile||
8284|026|U|acid-binding resins. Bile acid is a natural substance the liver||
8284|027|U|makes by using cholesterol. This medication works by removing||
8284|028|U|bile acid from the body. This causes the liver to make more bile||
8284|029|U|acid by using cholesterol, which reduces cholesterol levels in||
8284|030|U|the blood. It is not known how colesevelam works in lowering||
8284|031|U|blood sugar.||
8284|032|B|||
8284|033|H|HOW TO USE:  Take this medication by mouth with a meal as||
8284|034|H|directed by your doctor, usually 1 to 2 times daily. Take the||
8284|035|H|tablet form with a liquid (such as water, milk). If you have||
8284|036|H|trouble swallowing the tablet, talk to your doctor about||
8284|037|H|switching to the powder form of this medication.||
8284|038|H|   If you are using the powder form of this medication, pour the||
8284|039|H|contents of one packet into a glass. Add one cup (8 ounces/240||
8284|040|H|milliliters) of water, fruit juice, or diet soda. Stir the||
8284|041|H|mixture well and drink all of it. Do not take the powder without||
8284|042|H|mixing it in liquid.||
8284|043|H|   Take this medication regularly to get the most benefit from||
8284|044|H|it. To help you remember, take it at the same time(s) each day.||
8284|045|H|   It may take several weeks before you get the full benefit of||
8284|046|H|this drug.||
8284|047|H|   Colesevelam may decrease the absorption of other products you||
8284|048|H|may be taking. Some examples include cyclosporine, glipizide,||
8284|049|H|glimepiride, glyburide, levothyroxine, and phenytoin, as well as||
8284|050|H|birth control pills that contain ethinyl estradiol and||
8284|051|H|norethindrone. Take other medications as directed by your doctor,||
8284|052|H|usually at least 4 hours before taking your colesevelam dose. Ask||
8284|053|H|your pharmacist if you are not sure when to take your||
8284|054|H|medications.||
8284|055|B|||
8284|056|S|SIDE EFFECTS:  Constipation and upset stomach may occur. If any||
8284|057|S|of these effects last or get worse, tell your doctor or||
8284|058|S|pharmacist promptly.||
8284|059|S|   To prevent constipation, eat dietary fiber, drink enough||
8284|060|S|water, and exercise. You may also need to take a laxative. Ask||
8284|061|S|your pharmacist which type of laxative is right for you.||
8284|062|S|   Remember that this medication has been prescribed because your||
8284|063|S|doctor has judged that the benefit to you is greater than the||
8284|064|S|risk of side effects. Many people using this medication do not||
8284|065|S|have serious side effects.||
8284|066|S|   Tell your doctor right away if you have any serious side||
8284|067|S|effects, including: nausea/vomiting, stomach/abdominal pain,||
8284|068|S|trouble swallowing, unusual bleeding/bruising.||
8284|069|S|   This medication does not usually cause low blood sugar||
8284|070|S|(hypoglycemia). Low blood sugar may occur if this drug is||
8284|071|S|prescribed with other diabetes medications, or if you do not get||
8284|072|S|enough calories from food, or if you do unusually heavy exercise.||
8284|073|S|Talk with your doctor or pharmacist about whether the dose of||
8284|074|S|your other diabetes medication(s) needs to be lowered. Symptoms||
8284|075|S|of low blood sugar include sudden sweating, shaking, fast||
8284|076|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
8284|077|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
8284|078|S|treat low blood sugar. If you don't have these reliable forms of||
8284|079|S|glucose, rapidly raise your blood sugar by eating a quick source||
8284|080|S|of sugar such as table sugar, honey, or candy, or drink fruit||
8284|081|S|juice or non-diet soda. Tell your doctor right away about the||
8284|082|S|reaction and the use of this product. To help prevent low blood||
8284|083|S|sugar, eat meals on a regular schedule, and do not skip meals.||
8284|084|S|Check with your doctor or pharmacist to find out what you should||
8284|085|S|do if you miss a meal.||
8284|086|S|   Symptoms of high blood sugar (hyperglycemia) include thirst,||
8284|087|S|increased urination, confusion, drowsiness, flushing, rapid||
8284|088|S|breathing, and fruity breath odor. If these symptoms occur, tell||
8284|089|S|your doctor right away. Your dosage may need to be increased.||
8284|090|S|   A very serious allergic reaction to this drug is rare.||
8284|091|S|However, get medical help right away if you notice any symptoms||
8284|092|S|of a serious allergic reaction, including: rash, itching/swelling||
8284|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8284|094|S|breathing.||
8284|095|S|   This is not a complete list of possible side effects. If you||
8284|096|S|notice other effects not listed above, contact your doctor or||
8284|097|S|pharmacist.||
8284|098|S|   In the US -||
8284|099|S|   Call your doctor for medical advice about side effects. You||
8284|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8284|101|S|www.fda.gov/medwatch.||
8284|102|S|   In Canada - Call your doctor for medical advice about side||
8284|103|S|effects. You may report side effects to Health Canada at||
8284|104|S|1-866-234-2345.||
8284|105|B|||
8284|106|P|PRECAUTIONS:  Before taking colesevelam, tell your doctor or||
8284|107|P|pharmacist if you are allergic to it; or if you have any other||
8284|108|P|allergies. This product may contain inactive ingredients, which||
8284|109|P|can cause allergic reactions or other problems. Talk to your||
8284|110|P|pharmacist for more details.||
8284|111|P|   Before using this medication, tell your doctor or pharmacist||
8284|112|P|your medical history, especially of: pancreatitis (caused by high||
8284|113|P|triglyceride levels), high triglyceride levels, trouble||
8284|114|P|swallowing, stomach/intestinal disorders (such as constipation,||
8284|115|P|blockage, gastroparesis), recent major intestinal surgery,||
8284|116|P|hemorrhoids.||
8284|117|P|   Because this drug can interfere with the absorption of certain||
8284|118|P|vitamins (such as vitamins A, D, E, K) when used for a long||
8284|119|P|period of time, your doctor may direct you to take a multivitamin||
8284|120|P|supplement. Take the multivitamin at least 4 hours before taking||
8284|121|P|your colesevelam dose.||
8284|122|P|   The powder form of this medication may contain aspartame. If||
8284|123|P|you have phenylketonuria (PKU) or any other condition that||
8284|124|P|requires you to restrict your intake of aspartame (or||
8284|125|P|phenylalanine), consult your doctor or pharmacist about using||
8284|126|P|this medication safely.||
8284|127|P|   Before having surgery, tell your doctor or dentist about all||
8284|128|P|the products you use (including prescription drugs,||
8284|129|P|nonprescription drugs, and herbal products).||
8284|130|P|   Tell your doctor if you are pregnant before using this||
8284|131|P|medication.||
8284|132|P|   This medication is unlikely to pass into breast milk or harm a||
8284|133|P|nursing infant. Consult your doctor before breastfeeding.||
8284|134|B|||
8284|135|I|DRUG INTERACTIONS:  See also How to Use section.||
8284|136|I|   Drug interactions may change how your medications work or||
8284|137|I|increase your risk for serious side effects. This document does||
8284|138|I|not contain all possible drug interactions. Keep a list of all||
8284|139|I|the products you use (including prescription/nonprescription||
8284|140|I|drugs and herbal products) and share it with your doctor and||
8284|141|I|pharmacist. Do not start, stop, or change the dosage of any||
8284|142|I|medicines without your doctor's approval.||
8284|143|I|   Some products that may interact with this drug include:||
8284|144|I|raloxifene, warfarin.||
8284|145|I|   Beta-blocker medications (such as metoprolol, propranolol,||
8284|146|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
8284|147|I|heartbeat you would usually feel when your blood sugar falls too||
8284|148|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
8284|149|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
8284|150|I|   Many drugs can affect your blood sugar, making it harder to||
8284|151|I|control. Before you start, stop, or change any medication, talk||
8284|152|I|with your doctor or pharmacist about how the medication may||
8284|153|I|affect your blood sugar. Check your blood sugar regularly as||
8284|154|I|directed and share the results with your doctor. Tell your doctor||
8284|155|I|right away if you have symptoms of high or low blood sugar. (See||
8284|156|I|also Side Effects section.) Your doctor may need to adjust your||
8284|157|I|diabetes medication, exercise program, or diet.||
8284|158|B|||
8284|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8284|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8284|161|O|poison control center right away. US residents can call||
8284|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8284|163|B|||
8284|164|N|NOTES:  Do not share this medication with others.||
8284|165|N|   Lab and/or medical tests (such as blood cholesterol levels,||
8284|166|N|blood sugar) should be done while you are taking this medication.||
8284|167|N|Keep all medical and lab appointments. Consult your doctor for||
8284|168|N|more details.||
8284|169|N|   Lifestyle changes that may help this medication work better||
8284|170|N|include exercising, stopping smoking, and eating a||
8284|171|N|low-cholesterol/low-fat diet. Consult your doctor for more||
8284|172|N|details.||
8284|173|N|   Attend a diabetes education program to learn more about how to||
8284|174|N|manage your diabetes with medications, diet, exercise, and||
8284|175|N|regular medical exams.||
8284|176|N|   Learn the symptoms of high and low blood sugar and how to||
8284|177|N|treat low blood sugar. Check your blood sugar regularly as||
8284|178|N|directed and share the results with your doctor.||
8284|179|B|||
8284|180|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
8284|181|D|with a meal. If it is near the time of the next dose, skip the||
8284|182|D|missed dose. Take your next dose at the regular time. Do not||
8284|183|D|double the dose to catch up.||
8284|184|B|||
8284|185|R|STORAGE:  Store at room temperature away from light and moisture.||
8284|186|R|Do not store in the bathroom. Keep all medications away from||
8284|187|R|children and pets.||
8284|188|R|   Do not flush medications down the toilet or pour them into a||
8284|189|R|drain unless instructed to do so. Properly discard this product||
8284|190|R|when it is expired or no longer needed. Consult your pharmacist||
8284|191|R|or local waste disposal company.||
8284|192|B|||
8284|193|A|Information last revised May 2025.||
8284|194|A|Copyright(c) 2025 First Databank, Inc.||
8284|195|B|||
8288|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8288|002|Z|does NOT have all possible information about this product. This||
8288|003|Z|information does not assure that this product is safe, effective,||
8288|004|Z|or appropriate for you. This information is not individual||
8288|005|Z|medical advice and does not substitute for the advice of your||
8288|006|Z|health care professional. Always ask your health care||
8288|007|Z|professional for complete information about this product and your||
8288|008|Z|specific health needs.||
8288|009|B|||
8288|010|T|VITAMIN E - ORAL||
8288|011|B|||
8288|012|C|COMMON BRAND NAME(S): Aquasol E||
8288|013|B|||
8288|014|U|USES:  This supplement is used to prevent or treat a lack of||
8288|015|U|vitamin E in the body. A low body level of vitamin E is rare.||
8288|016|U|Most people who eat a normal diet do not need extra vitamin E.||
8288|017|U|However, vitamin E supplements are used in premature newborns and||
8288|018|U|in people who have problems absorbing enough vitamin E from their||
8288|019|U|diets. Vitamin E is important in protecting your body's cells||
8288|020|U|from damage. It is known as an antioxidant.||
8288|021|B|||
8288|022|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
8288|023|H|directions on the product package. If you have any questions, ask||
8288|024|H|your doctor or pharmacist.||
8288|025|H|   If you are using a liquid form of this product, carefully||
8288|026|H|measure your dose using a medication-measuring device or spoon.||
8288|027|H|Do not use a household spoon because you may not get the correct||
8288|028|H|dose. If your liquid form is a suspension, shake the bottle well||
8288|029|H|before each dose.||
8288|030|H|   The dosage is based on your medical condition and response to||
8288|031|H|treatment. Do not increase your dose or take it more often than||
8288|032|H|recommended. Taking too much vitamin E may increase your risk of||
8288|033|H|side effects.||
8288|034|H|   High doses of vitamin E (400 units or more per day) may||
8288|035|H|increase the chance of rare but very serious side effects. There||
8288|036|H|is no proof that high doses of vitamin E help to prevent or treat||
8288|037|H|heart disease. There is very little evidence that it helps||
8288|038|H|prevent or treat Alzheimer's disease. In some people, taking||
8288|039|H|these high doses may even be harmful. Talk to your doctor or||
8288|040|H|pharmacist and discuss the risks and benefits before taking||
8288|041|H|vitamin E supplements.||
8288|042|H|   If your doctor prescribes this product for vitamin E||
8288|043|H|deficiency, use it regularly to get the most benefit from it. To||
8288|044|H|help you remember, take it at the same time each day. You should||
8288|045|H|see improvement of symptoms such as numbness/tingling of the||
8288|046|H|hands/feet and weakness. Tell your doctor if your condition lasts||
8288|047|H|or gets worse. If you think you may have a serious medical||
8288|048|H|problem, get medical help right away.||
8288|049|B|||
8288|050|S|SIDE EFFECTS:  Vitamin E does not usually cause side effects when||
8288|051|S|used in recommended doses.||
8288|052|S|   However, vitamin E may cause side effects if taken at high||
8288|053|S|doses (400 units or more per day) or for a long period of time.||
8288|054|S|In these situations, nausea, diarrhea, stomach cramps, tiredness,||
8288|055|S|dizziness, blurred vision, and headache may rarely occur. If any||
8288|056|S|of these effects last or get worse, tell your doctor or||
8288|057|S|pharmacist promptly.||
8288|058|S|   If your doctor has directed you to use this medication,||
8288|059|S|remember that your doctor has judged that the benefit to you is||
8288|060|S|greater than the risk of side effects. Many people using this||
8288|061|S|medication do not have serious side effects.||
8288|062|S|   Tell your doctor right away if you have any serious side||
8288|063|S|effects, including: easy bleeding/bruising.||
8288|064|S|   A very serious allergic reaction to this drug is rare.||
8288|065|S|However, get medical help right away if you notice any symptoms||
8288|066|S|of a serious allergic reaction, including: rash, itching/swelling||
8288|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8288|068|S|breathing.||
8288|069|S|   This is not a complete list of possible side effects. If you||
8288|070|S|notice other effects not listed above, contact your doctor or||
8288|071|S|pharmacist.||
8288|072|S|   In the US -||
8288|073|S|   Call your doctor for medical advice about side effects. You||
8288|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8288|075|S|www.fda.gov/medwatch.||
8288|076|S|   In Canada - Call your doctor for medical advice about side||
8288|077|S|effects. You may report side effects to Health Canada at||
8288|078|S|1-866-234-2345.||
8288|079|B|||
8288|080|P|PRECAUTIONS:  Before taking vitamin E, tell your doctor or||
8288|081|P|pharmacist if you are allergic to it; or to other ingredients||
8288|082|P|listed on the package label; or if you have any other allergies.||
8288|083|P|This product may contain inactive ingredients (such as soybeans),||
8288|084|P|which can cause allergic reactions or other problems. Talk to||
8288|085|P|your pharmacist for more details.||
8288|086|P|   If you have any of the following health problems, consult your||
8288|087|P|doctor or pharmacist before using this product: blood||
8288|088|P|clotting/bleeding disorders, kidney problems, liver problems,||
8288|089|P|high blood fats (cholesterol/triglycerides).||
8288|090|P|   At high dosages, this product may rarely make you dizzy or||
8288|091|P|blur your vision. Alcohol or marijuana (cannabis) can make you||
8288|092|P|more dizzy. Do not drive, use machinery, or do anything that||
8288|093|P|needs alertness or clear vision until you can do it safely. Limit||
8288|094|P|alcoholic beverages. Talk to your doctor if you are using||
8288|095|P|marijuana (cannabis).||
8288|096|P|   Some brands of this product may contain sugar, alcohol, or||
8288|097|P|aspartame. Caution is advised if you have diabetes, alcohol||
8288|098|P|dependence, liver disease, phenylketonuria (PKU), or any other||
8288|099|P|condition that requires you to limit/avoid these substances in||
8288|100|P|your diet. Ask your doctor or pharmacist about using this product||
8288|101|P|safely.||
8288|102|P|   Before having surgery, tell your doctor or dentist about all||
8288|103|P|the products you use (including prescription drugs,||
8288|104|P|nonprescription drugs, and herbal products).||
8288|105|P|   During pregnancy, this medication should be used only when||
8288|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
8288|107|P|   It is unknown if this drug passes into breast milk. Consult||
8288|108|P|your doctor before breastfeeding.||
8288|109|B|||
8288|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8288|111|I|medications work or increase your risk for serious side effects.||
8288|112|I|This document does not contain all possible drug interactions.||
8288|113|I|Keep a list of all the products you use (including||
8288|114|I|prescription/nonprescription drugs and herbal products) and share||
8288|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
8288|116|I|the dosage of any medicines without your doctor's approval.||
8288|117|I|   Some drugs that may interact with this product are: bile||
8288|118|I|acid-binding resins (such as cholestyramine, colestipol), "blood||
8288|119|I|thinners" (such as warfarin), iron supplements, mineral oil.||
8288|120|I|   If you are also taking orlistat, separate the time between||
8288|121|I|orlistat and vitamin E doses by at least 2 hours.||
8288|122|I|   Check the labels on all your prescription and||
8288|123|I|nonprescription/herbal products because they may contain vitamin||
8288|124|I|E. Ask your doctor or pharmacist about using those products||
8288|125|I|safely.||
8288|126|B|||
8288|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8288|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8288|129|O|poison control center right away. US residents can call||
8288|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8288|131|B|||
8288|132|N|NOTES:  Keep all medical and lab appointments.||
8288|133|N|   Eat a well-balanced diet. Foods high in vitamin E include||
8288|134|N|vegetable oils, wheat germ oil, whole grain cereals, meat,||
8288|135|N|poultry, and green leafy vegetables.||
8288|136|B|||
8288|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8288|138|D|remember. If it is near the time of the next dose, skip the||
8288|139|D|missed dose. Take your next dose at the regular time. Do not||
8288|140|D|double the dose to catch up.||
8288|141|B|||
8288|142|R|STORAGE:  Store according to the product package directions away||
8288|143|R|from heat, light, and moisture. Do not store in the bathroom. If||
8288|144|R|you have any questions about storage, ask your pharmacist. Keep||
8288|145|R|all medications away from children and pets.||
8288|146|R|   Do not flush medications down the toilet or pour them into a||
8288|147|R|drain unless instructed to do so. Properly discard this product||
8288|148|R|when it is expired or no longer needed. Consult your pharmacist||
8288|149|R|or local waste disposal company.||
8288|150|B|||
8288|151|A|Information last revised November 2025.||
8288|152|A|Copyright(c) 2025 First Databank, Inc.||
8288|153|B|||
8296|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8296|002|Z|does NOT have all possible information about this product. This||
8296|003|Z|information does not assure that this product is safe, effective,||
8296|004|Z|or appropriate for you. This information is not individual||
8296|005|Z|medical advice and does not substitute for the advice of your||
8296|006|Z|health care professional. Always ask your health care||
8296|007|Z|professional for complete information about this product and your||
8296|008|Z|specific health needs.||
8296|009|B|||
8296|010|T|ONDANSETRON DISINTEGRATING TABLET - ORAL||
8296|011|F|(on-DANCE-eh-tron)||
8296|012|B|||
8296|013|C|COMMON BRAND NAME(S): Zofran ODT||
8296|014|B|||
8296|015|U|USES:  This medication is used alone or with other medications to||
8296|016|U|prevent nausea and vomiting caused by cancer drug treatment||
8296|017|U|(chemotherapy) and radiation therapy. It is also used to prevent||
8296|018|U|and treat nausea and vomiting after surgery. Ondansetron works by||
8296|019|U|blocking one of the body's natural substances (serotonin) that||
8296|020|U|causes vomiting.||
8296|021|B|||
8296|022|H|HOW TO USE:  This medication is dissolved on top of the tongue.||
8296|023|H|It is not meant to be chewed or swallowed like other tablet||
8296|024|H|forms.||
8296|025|H|   Dry your hands before using this medication. This medication||
8296|026|H|may come in a bottle or a blister pack. If using the blister||
8296|027|H|pack, peel back the foil on the blister pack to remove a tablet.||
8296|028|H|Do not push the tablet through the foil. Immediately after||
8296|029|H|removing the tablet, place it on the tongue. Allow it to dissolve||
8296|030|H|completely, then swallow it with saliva. You do not need to take||
8296|031|H|this product with water. Doing so may increase your chance of||
8296|032|H|getting a headache.||
8296|033|H|   To prevent nausea from chemotherapy, take this medication||
8296|034|H|usually within 30 minutes before treatment begins. To prevent||
8296|035|H|nausea from radiation treatment, take this medication 1 to 2||
8296|036|H|hours before the start of your treatment. To prevent nausea after||
8296|037|H|surgery, take ondansetron 1 hour before the start of surgery.||
8296|038|H|This medication may be taken with or without food. However, your||
8296|039|H|doctor may tell you not to eat before chemotherapy, radiation, or||
8296|040|H|surgery.||
8296|041|H|   Take any other doses as directed by your doctor. Ondansetron||
8296|042|H|may be taken up to 3 times a day for 1 to 2 days after your||
8296|043|H|chemotherapy or radiation treatment is finished. If you are||
8296|044|H|taking this medication on a prescribed schedule, take it||
8296|045|H|regularly in order to get the most benefit from it. To help you||
8296|046|H|remember, take it at the same times each day.||
8296|047|H|   The dosage is based on your medical condition and response to||
8296|048|H|treatment. Children's dosage may also be based on age and weight.||
8296|049|H|Take this medication exactly as directed. Do not take more||
8296|050|H|medication or take it more often than prescribed. Ask your doctor||
8296|051|H|or pharmacist if you have questions.||
8296|052|H|   Tell your doctor if your condition does not get better or if||
8296|053|H|it gets worse.||
8296|054|B|||
8296|055|S|SIDE EFFECTS:  Headache, lightheadedness, dizziness, drowsiness,||
8296|056|S|tiredness, or constipation may occur. If these effects last or||
8296|057|S|get worse, tell your doctor promptly.||
8296|058|S|   To reduce the risk of dizziness and lightheadedness, get up||
8296|059|S|slowly when rising from a sitting or lying position.||
8296|060|S|   Remember that this medication has been prescribed because your||
8296|061|S|doctor has judged that the benefit to you is greater than the||
8296|062|S|risk of side effects. Many people using this medication do not||
8296|063|S|have serious side effects.||
8296|064|S|   Tell your doctor right away if you have any serious side||
8296|065|S|effects, including: stomach pain, muscle spasm/stiffness, vision||
8296|066|S|changes (such as temporary loss of vision, blurred vision).||
8296|067|S|   Get medical help right away if you have any very serious side||
8296|068|S|effects, including: chest pain, slow/fast/irregular heartbeat,||
8296|069|S|severe dizziness, fainting.||
8296|070|S|   This medication may increase serotonin and rarely cause a very||
8296|071|S|serious condition called serotonin syndrome/toxicity. The risk||
8296|072|S|increases if you are also taking other drugs that increase||
8296|073|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
8296|074|S|take (see Drug Interactions section). Get medical help right away||
8296|075|S|if you develop some of the following symptoms: fast heartbeat,||
8296|076|S|hallucinations, loss of coordination, severe dizziness, severe||
8296|077|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
8296|078|S|unusual agitation/restlessness.||
8296|079|S|   A very serious allergic reaction to this drug is rare.||
8296|080|S|However, get medical help right away if you notice any symptoms||
8296|081|S|of a serious allergic reaction, including: rash, itching/swelling||
8296|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8296|083|S|breathing.||
8296|084|S|   This is not a complete list of possible side effects. If you||
8296|085|S|notice other effects not listed above, contact your doctor or||
8296|086|S|pharmacist.||
8296|087|S|   In the US -||
8296|088|S|   Call your doctor for medical advice about side effects. You||
8296|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8296|090|S|www.fda.gov/medwatch.||
8296|091|S|   In Canada - Call your doctor for medical advice about side||
8296|092|S|effects. You may report side effects to Health Canada at||
8296|093|S|1-866-234-2345.||
8296|094|B|||
8296|095|P|PRECAUTIONS:  Before taking ondansetron, tell your doctor or||
8296|096|P|pharmacist if you are allergic to it; or to other anti-nausea||
8296|097|P|serotonin blockers (such as granisetron); or if you have any||
8296|098|P|other allergies. This product may contain inactive ingredients,||
8296|099|P|which can cause allergic reactions or other problems. Talk to||
8296|100|P|your pharmacist for more details.||
8296|101|P|   Before using this medication, tell your doctor or pharmacist||
8296|102|P|your medical history, especially of: irregular heartbeat, liver||
8296|103|P|disease, stomach/intestinal problems (such as recent abdominal||
8296|104|P|surgery, ileus, swelling).||
8296|105|P|   Ondansetron may cause a condition that affects the heart||
8296|106|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8296|107|P|serious (rarely fatal) fast/irregular heartbeat and other||
8296|108|P|symptoms (such as severe dizziness, fainting) that need medical||
8296|109|P|attention right away.||
8296|110|P|   The risk of QT prolongation may be increased if you have||
8296|111|P|certain medical conditions or are taking other drugs that may||
8296|112|P|cause QT prolongation. Before using ondansetron, tell your doctor||
8296|113|P|or pharmacist of all the drugs you take and if you have any of||
8296|114|P|the following conditions: certain heart problems (heart failure,||
8296|115|P|slow heartbeat, QT prolongation in the EKG), family history of||
8296|116|P|certain heart problems (QT prolongation in the EKG, sudden||
8296|117|P|cardiac death).||
8296|118|P|   Low levels of potassium or magnesium in the blood may also||
8296|119|P|increase your risk of QT prolongation. This risk may increase if||
8296|120|P|you use certain drugs (such as diuretics/"water pills") or if you||
8296|121|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8296|122|P|Talk to your doctor about using ondansetron safely.||
8296|123|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8296|124|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8296|125|P|machinery, or do anything that needs alertness until you can do||
8296|126|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
8296|127|P|are using marijuana (cannabis).||
8296|128|P|   This medicine may contain aspartame. If you have||
8296|129|P|phenylketonuria (PKU) or any other condition that requires you to||
8296|130|P|restrict your intake of aspartame (or phenylalanine), consult||
8296|131|P|your doctor or pharmacist regarding the safe use of this||
8296|132|P|medicine.||
8296|133|P|   Older adults may be more sensitive to the side effects of this||
8296|134|P|drug, especially QT prolongation (see above).||
8296|135|P|   During pregnancy, this medication should be used only when||
8296|136|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
8296|137|P|benefits with your doctor.||
8296|138|P|   This medication passes into breast milk. Consult your doctor||
8296|139|P|before breastfeeding.||
8296|140|B|||
8296|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8296|142|I|medications work or increase your risk for serious side effects.||
8296|143|I|This document does not contain all possible drug interactions.||
8296|144|I|Keep a list of all the products you use (including||
8296|145|I|prescription/nonprescription drugs and herbal products) and share||
8296|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
8296|147|I|the dosage of any medicines without your doctor's approval.||
8296|148|I|   Some products that may interact with this drug are:||
8296|149|I|apomorphine, tramadol.||
8296|150|I|   The risk of serotonin syndrome/toxicity increases if you are||
8296|151|I|also taking other drugs that increase serotonin. Examples include||
8296|152|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
8296|153|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
8296|154|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
8296|155|I|serotonin syndrome/toxicity may be more likely when you start or||
8296|156|I|increase the dose of these drugs.||
8296|157|B|||
8296|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8296|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8296|160|O|poison control center right away. US residents can call||
8296|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8296|162|B|||
8296|163|N|NOTES:  Do not share this product with others.||
8296|164|N|   Lab and/or medical tests (such as EKG) should be done while||
8296|165|N|you are taking this medication. Keep all medical and lab||
8296|166|N|appointments. Consult your doctor for more details.||
8296|167|B|||
8296|168|D|MISSED DOSE:  Try to take each dose at the scheduled time. If you||
8296|169|D|miss a dose, take it as soon as you remember unless it is near||
8296|170|D|the time for the next dose. In that case, skip the missed dose.||
8296|171|D|Take your next dose at the regular time. Do not double the dose||
8296|172|D|to catch up.||
8296|173|B|||
8296|174|R|STORAGE:  Different brands of this medication have different||
8296|175|R|storage needs. Check the product package for instructions on how||
8296|176|R|to store your brand, or ask your pharmacist. Keep all medications||
8296|177|R|away from children and pets.||
8296|178|R|   Do not flush medications down the toilet or pour them into a||
8296|179|R|drain unless instructed to do so. Properly discard this product||
8296|180|R|when it is expired or no longer needed. Consult your pharmacist||
8296|181|R|or local waste disposal company.||
8296|182|B|||
8296|183|A|Information last revised June 2025.||
8296|184|A|Copyright(c) 2025 First Databank, Inc.||
8296|185|B|||
8297|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8297|002|Z|does NOT have all possible information about this product. This||
8297|003|Z|information does not assure that this product is safe, effective,||
8297|004|Z|or appropriate for you. This information is not individual||
8297|005|Z|medical advice and does not substitute for the advice of your||
8297|006|Z|health care professional. Always ask your health care||
8297|007|Z|professional for complete information about this product and your||
8297|008|Z|specific health needs.||
8297|009|B|||
8297|010|T|TADALAFIL - ORAL||
8297|011|F|(tah-DA-la-fil)||
8297|012|B|||
8297|013|C|COMMON BRAND NAME(S): Cialis||
8297|014|B|||
8297|015|U|USES:  Tadalafil is used to treat male sexual function problems||
8297|016|U|(impotence or erectile dysfunction-ED). In combination with||
8297|017|U|sexual stimulation, tadalafil works by increasing blood flow to||
8297|018|U|the penis to help a man get and keep an erection.||
8297|019|U|   Tadalafil is also used to treat the symptoms of an enlarged||
8297|020|U|prostate (benign prostatic hyperplasia-BPH). It helps to relieve||
8297|021|U|symptoms of BPH such as difficulty in beginning the flow of||
8297|022|U|urine, weak stream, and the need to urinate often or urgently||
8297|023|U|(including during the middle of the night). Tadalafil is thought||
8297|024|U|to work by relaxing the smooth muscle in the prostate and||
8297|025|U|bladder.||
8297|026|U|   This drug does not protect against sexually transmitted||
8297|027|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
8297|028|U|an effective barrier method (latex or polyurethane condom/dental||
8297|029|U|dams) during sexual activity will help to decrease your risk of||
8297|030|U|infection.||
8297|031|B|||
8297|032|V|OTHER USES:  This section contains uses of this drug that are not||
8297|033|V|listed in the approved professional labeling for the drug but||
8297|034|V|that may be prescribed by your health care professional. Use this||
8297|035|V|drug for a condition that is listed in this section only if it||
8297|036|V|has been so prescribed by your health care professional.||
8297|037|V|   Tadalafil is also available in another brand for high blood||
8297|038|V|pressure in the lungs (pulmonary hypertension).||
8297|039|B|||
8297|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8297|041|H|from your pharmacist before you start taking tadalafil and each||
8297|042|H|time you get a refill. If you have any questions, ask your doctor||
8297|043|H|or pharmacist.||
8297|044|H|   Take this medication by mouth, with or without food, as||
8297|045|H|directed by your doctor. Do not take tadalafil more often than||
8297|046|H|once daily.||
8297|047|H|   The manufacturer directs to swallow this medication whole.||
8297|048|H|However, many similar drugs (immediate-release tablets) can be||
8297|049|H|split/crushed. Follow your doctor's directions on how to take||
8297|050|H|this medication.||
8297|051|H|   The dosage is based on your medical condition, response to||
8297|052|H|treatment, and other medications you may be taking. Be sure to||
8297|053|H|tell your doctor and pharmacist about all the products you use||
8297|054|H|(including prescription drugs, nonprescription drugs, and herbal||
8297|055|H|products).||
8297|056|H|   To treat the symptoms of BPH, take this medication as directed||
8297|057|H|by your doctor, usually once a day. If you are also taking||
8297|058|H|finasteride with this medication to treat symptoms of BPH, talk||
8297|059|H|with your doctor about how long you should keep taking this||
8297|060|H|medication.||
8297|061|H|   To treat erectile dysfunction-ED, there are 2 ways that||
8297|062|H|tadalafil may be prescribed. Your doctor will determine which is||
8297|063|H|the best way for you to take tadalafil. Follow your doctor's||
8297|064|H|directions exactly since your dosage depends on how you are||
8297|065|H|taking it. The first way is to take it as needed, usually at||
8297|066|H|least 30 minutes before sexual activity. Tadalafil's effect on||
8297|067|H|sexual ability may last up to 36 hours.||
8297|068|H|   The second way to treat ED is to take tadalafil regularly,||
8297|069|H|once a day every day. If you take it this way, you may attempt||
8297|070|H|sexual activity at any time between your doses.||
8297|071|H|   If you are taking tadalafil to treat both ED and BPH, take it||
8297|072|H|as directed by your doctor, usually once a day. You may attempt||
8297|073|H|sexual activity at any time between your doses.||
8297|074|H|   If you are taking tadalafil once daily for BPH, or for ED, or||
8297|075|H|for both, take it regularly to get the most benefit from it. To||
8297|076|H|help you remember, take it at the same time each day.||
8297|077|H|   Tell your doctor if your condition does not get better or if||
8297|078|H|it gets worse.||
8297|079|B|||
8297|080|S|SIDE EFFECTS:  Headache, stomach upset, back pain, muscle pain,||
8297|081|S|stuffy nose, flushing, or dizziness may occur. If any of these||
8297|082|S|effects last or get worse, tell your doctor or pharmacist||
8297|083|S|promptly.||
8297|084|S|   To reduce the risk of dizziness and lightheadedness, get up||
8297|085|S|slowly when rising from a sitting or lying position.||
8297|086|S|   Remember that this medication has been prescribed because your||
8297|087|S|doctor has judged that the benefit to you is greater than the||
8297|088|S|risk of side effects. Many people using this medication do not||
8297|089|S|have serious side effects.||
8297|090|S|   Sexual activity may put extra strain on your heart, especially||
8297|091|S|if you have heart problems. If you have heart problems and||
8297|092|S|experience any of these serious side effects while having sex,||
8297|093|S|stop and get medical help right away: severe dizziness, fainting,||
8297|094|S|chest/jaw/left arm pain, nausea.||
8297|095|S|   Rarely, sudden decreased vision, including permanent||
8297|096|S|blindness, in one or both eyes (NAION) may occur. If this serious||
8297|097|S|problem occurs, stop taking tadalafil and get medical help right||
8297|098|S|away. You have a slightly greater chance of developing NAION if||
8297|099|S|you have heart disease, diabetes, high cholesterol, certain other||
8297|100|S|eye problems ("crowded disk"), high blood pressure, if you are||
8297|101|S|over 50, or if you smoke.||
8297|102|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
8297|103|S|ringing in the ears and dizziness, may occur. Stop taking||
8297|104|S|tadalafil and get medical help right away if these effects occur.||
8297|105|S|   In the rare event you have a painful or prolonged erection||
8297|106|S|lasting 4 or more hours, stop using this drug and get medical||
8297|107|S|help right away, or permanent problems could occur.||
8297|108|S|   A very serious allergic reaction to this drug is rare.||
8297|109|S|However, get medical help right away if you notice any symptoms||
8297|110|S|of a serious allergic reaction, including: rash, itching/swelling||
8297|111|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8297|112|S|breathing.||
8297|113|S|   This is not a complete list of possible side effects. If you||
8297|114|S|notice other effects not listed above, contact your doctor or||
8297|115|S|pharmacist.||
8297|116|S|   In the US -||
8297|117|S|   Call your doctor for medical advice about side effects. You||
8297|118|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8297|119|S|www.fda.gov/medwatch.||
8297|120|S|   In Canada - Call your doctor for medical advice about side||
8297|121|S|effects. You may report side effects to Health Canada at||
8297|122|S|1-866-234-2345.||
8297|123|B|||
8297|124|P|PRECAUTIONS:  Before taking tadalafil, tell your doctor or||
8297|125|P|pharmacist if you are allergic to it; or if you have any other||
8297|126|P|allergies. This product may contain inactive ingredients, which||
8297|127|P|can cause allergic reactions or other problems. Talk to your||
8297|128|P|pharmacist for more details.||
8297|129|P|   Before using this medication, tell your doctor or pharmacist||
8297|130|P|your medical history, especially of: heart problems (such as||
8297|131|P|heart attack or life-threatening irregular heartbeat in the past||
8297|132|P|6 months, chest pain/angina, heart failure), stroke in the past 6||
8297|133|P|months, kidney disease, liver disease, high or low blood||
8297|134|P|pressure, dehydration, penis conditions (such as angulation,||
8297|135|P|fibrosis/scarring, Peyronie's disease), history of||
8297|136|P|painful/prolonged erection (priapism), conditions that may||
8297|137|P|increase the risk of priapism (such as sickle cell anemia,||
8297|138|P|leukemia, multiple myeloma), eye problems (such as retinitis||
8297|139|P|pigmentosa, sudden decreased vision, NAION), bleeding disorders,||
8297|140|P|active stomach ulcers.||
8297|141|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8297|142|P|can make you more dizzy. Do not drive, use machinery, or do||
8297|143|P|anything that needs alertness until you can do it safely. Limit||
8297|144|P|alcoholic beverages. Talk to your doctor if you are using||
8297|145|P|marijuana (cannabis).||
8297|146|P|   Before having surgery, tell your doctor or dentist about all||
8297|147|P|the products you use (including prescription drugs,||
8297|148|P|nonprescription drugs, and herbal products).||
8297|149|P|   This brand of the drug is not usually used in women. During||
8297|150|P|pregnancy, tadalafil should be used only when clearly needed.||
8297|151|P|Discuss the risks and benefits with your doctor.||
8297|152|P|   It is unknown if this medication passes into breast milk.||
8297|153|P|Consult your doctor before breastfeeding.||
8297|154|B|||
8297|155|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8297|156|I|medications work or increase your risk for serious side effects.||
8297|157|I|This document does not contain all possible drug interactions.||
8297|158|I|Keep a list of all the products you use (including||
8297|159|I|prescription/nonprescription drugs and herbal products) and share||
8297|160|I|it with your doctor and pharmacist. Do not start, stop, or change||
8297|161|I|the dosage of any medicines without your doctor's approval.||
8297|162|I|   Some products that may interact with this drug are: riociguat,||
8297|163|I|vericiguat.||
8297|164|I|   Tadalafil can cause a serious drop in your blood pressure when||
8297|165|I|used with nitrates, which can lead to dizziness, fainting, and||
8297|166|I|rarely heart attack or stroke. Do not use any of the following||
8297|167|I|with tadalafil or within 48 hours of your last dose of tadalafil:||
8297|168|I|certain drugs used to treat chest pain/angina (nitrates such as||
8297|169|I|nitroglycerin, isosorbide), recreational drugs called "poppers"||
8297|170|I|containing amyl or butyl nitrite.||
8297|171|I|   If you are also taking an alpha blocker medication (such as||
8297|172|I|doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high||
8297|173|I|blood pressure, your blood pressure may get too low which can||
8297|174|I|lead to dizziness or fainting. Your doctor may start treatment||
8297|175|I|with a lower dose of tadalafil or adjust your alpha blocker||
8297|176|I|medication to minimize your risk of low blood pressure.||
8297|177|I|   Other medications can affect the removal of tadalafil from||
8297|178|I|your body, which may affect how tadalafil works. Examples include||
8297|179|I|azole antifungals (such as itraconazole, ketoconazole), macrolide||
8297|180|I|antibiotics (such as clarithromycin, erythromycin), HIV protease||
8297|181|I|inhibitors (such as fosamprenavir), rifampin, ritonavir, among||
8297|182|I|others.||
8297|183|I|   Do not take this medication with any other product that||
8297|184|I|contains tadalafil or other similar medications used to treat||
8297|185|I|erectile dysfunction-ED or pulmonary hypertension (such as||
8297|186|I|sildenafil, vardenafil).||
8297|187|B|||
8297|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8297|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8297|190|O|poison control center right away. US residents can call||
8297|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8297|192|B|||
8297|193|N|NOTES:  Do not share this medication with others.||
8297|194|B|||
8297|195|D|MISSED DOSE:  If you are taking this medication on a regular||
8297|196|D|schedule and you miss a dose, take it as soon as you remember. If||
8297|197|D|it is near the time of the next dose, skip the missed dose. Take||
8297|198|D|your next dose at the regular time. Do not double the dose to||
8297|199|D|catch up.||
8297|200|B|||
8297|201|R|STORAGE:  Store at room temperature away from light and moisture.||
8297|202|R|Do not store in the bathroom. Keep all medications away from||
8297|203|R|children and pets.||
8297|204|R|   Do not flush medications down the toilet or pour them into a||
8297|205|R|drain unless instructed to do so. Properly discard this product||
8297|206|R|when it is expired or no longer needed. Consult your pharmacist||
8297|207|R|or local waste disposal company.||
8297|208|B|||
8297|209|A|Information last revised October 2025.||
8297|210|A|Copyright(c) 2025 First Databank, Inc.||
8297|211|B|||
8300|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8300|002|Z|does NOT have all possible information about this product. This||
8300|003|Z|information does not assure that this product is safe, effective,||
8300|004|Z|or appropriate for you. This information is not individual||
8300|005|Z|medical advice and does not substitute for the advice of your||
8300|006|Z|health care professional. Always ask your health care||
8300|007|Z|professional for complete information about this product and your||
8300|008|Z|specific health needs.||
8300|009|B|||
8300|010|T|MEGESTROL SUSPENSION - ORAL||
8300|011|F|(me-JES-trol)||
8300|012|B|||
8300|013|C|COMMON BRAND NAME(S): Megace||
8300|014|B|||
8300|015|U|USES:  Megestrol is used to treat loss of appetite and weight||
8300|016|U|loss in people with AIDS. Improving your appetite and gaining||
8300|017|U|weight may help you feel better and be more active.||
8300|018|U|   Megestrol is similar to a natural substance made by the body||
8300|019|U|called progesterone.||
8300|020|B|||
8300|021|V|OTHER USES:  This section contains uses of this drug that are not||
8300|022|V|listed in the approved professional labeling for the drug but||
8300|023|V|that may be prescribed by your health care professional. Use this||
8300|024|V|drug for a condition that is listed in this section only if it||
8300|025|V|has been so prescribed by your health care professional.||
8300|026|V|   This drug may also be used to counter unhealthy weight loss in||
8300|027|V|people with certain cancers by improving their appetite. It may||
8300|028|V|also be used for cancer of the breast, uterus, ovaries, or||
8300|029|V|prostate.||
8300|030|B|||
8300|031|H|HOW TO USE:  Take this medication by mouth as directed by your||
8300|032|H|doctor, usually once daily. Shake the bottle well before each||
8300|033|H|dose. Carefully measure the dose using a special measuring||
8300|034|H|device/spoon. Do not use a household spoon because you may not||
8300|035|H|get the correct dose.||
8300|036|H|   Do not switch between different liquid forms of megestrol||
8300|037|H|because you may not get the correct dose.||
8300|038|H|   The dosage is based on your medical condition and response to||
8300|039|H|treatment.||
8300|040|H|   Use this medication regularly to get the most benefit from it.||
8300|041|H|To help you remember, take it at the same time each day.||
8300|042|H|   Do not increase your dose or use this drug more often or for||
8300|043|H|longer than prescribed. Your condition will not improve any||
8300|044|H|faster, and your risk of side effects will increase.||
8300|045|H|   Since this drug can be absorbed through the skin and may harm||
8300|046|H|an unborn baby, women who are pregnant or who may become pregnant||
8300|047|H|should handle this medication carefully. Wash your skin well||
8300|048|H|right away if megestrol gets on your skin.||
8300|049|H|   It may take up to several weeks before you get the full||
8300|050|H|benefit of this drug.||
8300|051|H|   Tell your doctor if you do not get better or if you get worse.||
8300|052|B|||
8300|053|S|SIDE EFFECTS:  Trouble sleeping, fever, gas, decreased sexual||
8300|054|S|ability/desire, or upset stomach may occur. Women may have||
8300|055|S|changes in their menstrual periods, such as unpredictable||
8300|056|S|bleeding. If any of these effects last or get worse, tell your||
8300|057|S|doctor or pharmacist promptly.||
8300|058|S|   Remember that this medication has been prescribed because your||
8300|059|S|doctor has judged that the benefit to you is greater than the||
8300|060|S|risk of side effects. Many people using this medication do not||
8300|061|S|have serious side effects.||
8300|062|S|   Tell your doctor right away if you have any serious side||
8300|063|S|effects, including: fast/pounding heartbeat, tiredness, headache,||
8300|064|S|swelling of the hands/feet.||
8300|065|S|   This medication may rarely make your blood sugar rise, which||
8300|066|S|can cause or worsen diabetes. Tell your doctor right away if you||
8300|067|S|have symptoms of high blood sugar such as increased||
8300|068|S|thirst/urination. If you already have diabetes, check your blood||
8300|069|S|sugar regularly as directed and share the results with your||
8300|070|S|doctor. Your doctor may need to adjust your diabetes medication,||
8300|071|S|exercise program, or diet.||
8300|072|S|   Get medical help right away if you have any very serious side||
8300|073|S|effects, including: symptoms of a blood clot (such as chest pain,||
8300|074|S|trouble breathing, pain/redness/swelling of arms or legs),||
8300|075|S|confusion, mental/mood changes, weakness/numbness on one side of||
8300|076|S|the body, trouble speaking, vision changes.||
8300|077|S|   A very serious allergic reaction to this drug is rare.||
8300|078|S|However, get medical help right away if you notice any symptoms||
8300|079|S|of a serious allergic reaction, including: rash, itching/swelling||
8300|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8300|081|S|breathing.||
8300|082|S|   This is not a complete list of possible side effects. If you||
8300|083|S|notice other effects not listed above, contact your doctor or||
8300|084|S|pharmacist.||
8300|085|S|   In the US -||
8300|086|S|   Call your doctor for medical advice about side effects. You||
8300|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8300|088|S|www.fda.gov/medwatch.||
8300|089|S|   In Canada - Call your doctor for medical advice about side||
8300|090|S|effects. You may report side effects to Health Canada at||
8300|091|S|1-866-234-2345.||
8300|092|B|||
8300|093|P|PRECAUTIONS:  Before taking megestrol, tell your doctor or||
8300|094|P|pharmacist if you are allergic to it; or if you have any other||
8300|095|P|allergies. This product may contain inactive ingredients, which||
8300|096|P|can cause allergic reactions or other problems. Talk to your||
8300|097|P|pharmacist for more details.||
8300|098|P|   Before using this medication, tell your doctor or pharmacist||
8300|099|P|your medical history, especially of: adrenal gland problems (such||
8300|100|P|as Cushing's syndrome), blood clots, diabetes, heart disease||
8300|101|P|(such as heart failure), high blood pressure, kidney disease,||
8300|102|P|unusual vaginal bleeding.||
8300|103|P|   If you have diabetes, this product may affect your blood||
8300|104|P|sugar. Check your blood sugar regularly as directed and share the||
8300|105|P|results with your doctor. Tell your doctor right away if you have||
8300|106|P|symptoms of high blood sugar (see Side Effects section). Your||
8300|107|P|doctor may need to adjust your diabetes medication, exercise||
8300|108|P|program, or diet.||
8300|109|P|   Using megestrol for a long time may make it more difficult for||
8300|110|P|your body to respond to physical stress. Before having surgery or||
8300|111|P|emergency treatment, or if you get a serious illness/injury, tell||
8300|112|P|your doctor or dentist that you are using this medication or have||
8300|113|P|recently stopped taking it. Tell your doctor right away if you||
8300|114|P|develop unusual/extreme tiredness, dizziness, nausea, or||
8300|115|P|vomiting.||
8300|116|P|   Older adults may be more sensitive to the side effects of this||
8300|117|P|drug, especially the risk for blood clots.||
8300|118|P|   This medication must not be used during pregnancy. It may harm||
8300|119|P|an unborn baby. Your doctor should order a pregnancy test before||
8300|120|P|you start this medication. Discuss the use of reliable forms of||
8300|121|P|birth control (such as condoms, birth control pills) with your||
8300|122|P|doctor. If you become pregnant or think you may be pregnant, tell||
8300|123|P|your doctor right away.||
8300|124|P|   This medication passes into breast milk. Because of the||
8300|125|P|possible risk to the infant, breastfeeding is not recommended||
8300|126|P|while using this medication. Consult your doctor before||
8300|127|P|breastfeeding.||
8300|128|B|||
8300|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8300|130|I|medications work or increase your risk for serious side effects.||
8300|131|I|This document does not contain all possible drug interactions.||
8300|132|I|Keep a list of all the products you use (including||
8300|133|I|prescription/nonprescription drugs and herbal products) and share||
8300|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
8300|135|I|the dosage of any medicines without your doctor's approval.||
8300|136|I|   A product that may interact with this drug is: dofetilide.||
8300|137|B|||
8300|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8300|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8300|140|O|poison control center right away. US residents can call||
8300|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8300|142|B|||
8300|143|N|NOTES:  Do not share this medication with others.||
8300|144|N|   Lab and/or medical tests (such as blood pressure, blood sugar)||
8300|145|N|may be done while you are taking this medication. Keep all||
8300|146|N|medical and lab appointments. Consult your doctor for more||
8300|147|N|details.||
8300|148|B|||
8300|149|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8300|150|D|remember. If it is near the time of the next dose, skip the||
8300|151|D|missed dose. Take your next dose at the regular time. Do not||
8300|152|D|double the dose to catch up.||
8300|153|B|||
8300|154|R|STORAGE:  Store at room temperature away from heat. Keep all||
8300|155|R|medications away from children and pets.||
8300|156|R|   Do not flush medications down the toilet or pour them into a||
8300|157|R|drain unless instructed to do so. Properly discard this product||
8300|158|R|when it is expired or no longer needed. Consult your pharmacist||
8300|159|R|or local waste disposal company.||
8300|160|B|||
8300|161|A|Information last revised October 2024.||
8300|162|A|Copyright(c) 2025 First Databank, Inc.||
8300|163|B|||
8301|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8301|002|Z|does NOT have all possible information about this product. This||
8301|003|Z|information does not assure that this product is safe, effective,||
8301|004|Z|or appropriate for you. This information is not individual||
8301|005|Z|medical advice and does not substitute for the advice of your||
8301|006|Z|health care professional. Always ask your health care||
8301|007|Z|professional for complete information about this product and your||
8301|008|Z|specific health needs.||
8301|009|B|||
8301|010|T|BASILIXIMAB - INJECTION||
8301|011|F|(BA-si-LIX-i-mab)||
8301|012|B|||
8301|013|C|COMMON BRAND NAME(S): Simulect||
8301|014|B|||
8301|015|U|USES:  Basiliximab is used to prevent organ rejection in people||
8301|016|U|who have received a kidney transplant. It is usually taken along||
8301|017|U|with other medications (such as cyclosporine, corticosteroids) to||
8301|018|U|allow your new organ to function normally. Basiliximab is an||
8301|019|U|immunosuppressant drug known as a monoclonal antibody. It works||
8301|020|U|by slowing down your body's defense system (immune system) to||
8301|021|U|prevent your body from rejecting the new kidney after surgery||
8301|022|U|(acute rejection).||
8301|023|B|||
8301|024|H|HOW TO USE:  This medication is given by injection into a vein by||
8301|025|H|a health care professional. It is usually given in 2 doses. The||
8301|026|H|first dose is given within 2 hours before the transplant surgery,||
8301|027|H|and the second dose is given 4 days after surgery.||
8301|028|H|   The dosage is based on your age, weight, medical condition,||
8301|029|H|and response to treatment.||
8301|030|H|   This medication is used with other medications (such as||
8301|031|H|cyclosporine, corticosteroids) to prevent rejection of||
8301|032|H|transplanted organs. Take all medications exactly as prescribed||
8301|033|H|by your doctor. If you have any questions, ask your doctor or||
8301|034|H|pharmacist.||
8301|035|B|||
8301|036|S|SIDE EFFECTS:  Nausea, stomach pain, diarrhea, constipation, or||
8301|037|S|pain/redness at the injection site may occur. If any of these||
8301|038|S|effects last or get worse, tell your doctor or pharmacist||
8301|039|S|promptly.||
8301|040|S|   Remember that this medication has been prescribed because your||
8301|041|S|doctor has judged that the benefit to you is greater than the||
8301|042|S|risk of side effects. Many people using this medication do not||
8301|043|S|have serious side effects.||
8301|044|S|   The use of medications that affect the immune system may lead||
8301|045|S|to increased risk of infection or certain types of cancer. Tell||
8301|046|S|your doctor right away if you have any serious side effects,||
8301|047|S|including: sore throat that doesn't go away, fever, weakness,||
8301|048|S|swollen lymph nodes, night sweats, unusual lumps, sores around||
8301|049|S|the mouth/genitals, pain with urination, vision changes,||
8301|050|S|unexplained weight loss.||
8301|051|S|   A very serious allergic reaction to this drug is rare.||
8301|052|S|However, get medical help right away if you notice any symptoms||
8301|053|S|of a serious allergic reaction, including: rash, itching/swelling||
8301|054|S|(especially of the face/tongue/throat), severe dizziness,||
8301|055|S|unusually fast heartbeat, sneezing, trouble breathing.||
8301|056|S|   This is not a complete list of possible side effects. If you||
8301|057|S|notice other effects not listed above, contact your doctor or||
8301|058|S|pharmacist.||
8301|059|S|   In the US -||
8301|060|S|   Call your doctor for medical advice about side effects. You||
8301|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8301|062|S|www.fda.gov/medwatch.||
8301|063|S|   In Canada - Call your doctor for medical advice about side||
8301|064|S|effects. You may report side effects to Health Canada at||
8301|065|S|1-866-234-2345.||
8301|066|B|||
8301|067|P|PRECAUTIONS:  Before using basiliximab, tell your doctor or||
8301|068|P|pharmacist if you are allergic to it; or if you have any other||
8301|069|P|allergies. This product may contain inactive ingredients, which||
8301|070|P|can cause allergic reactions or other problems. Talk to your||
8301|071|P|pharmacist for more details.||
8301|072|P|   Before using this medication, tell your doctor or pharmacist||
8301|073|P|your medical history, especially of: certain infection||
8301|074|P|(cytomegalovirus).||
8301|075|P|   Previous treatment with basiliximab may increase your risk of||
8301|076|P|a serious allergic reaction (see Side Effects section). Before||
8301|077|P|using this medication, tell your doctor or pharmacist if you have||
8301|078|P|received basiliximab in the past. If you must stop using this||
8301|079|P|drug due to an allergic reaction, do not use the drug again.||
8301|080|P|Consult your doctor or pharmacist for more details.||
8301|081|P|   Before having surgery, tell your doctor or dentist about all||
8301|082|P|the products you use (including prescription drugs,||
8301|083|P|nonprescription drugs, and herbal products).||
8301|084|P|   Basiliximab can make you more likely to get infections or may||
8301|085|P|make current infections worse. Stay away from anyone who has an||
8301|086|P|infection that may easily spread (such as chickenpox, COVID-19,||
8301|087|P|measles, flu). Talk to your doctor if you have been exposed to an||
8301|088|P|infection or for more details.||
8301|089|P|   Tell your health care professional that you are using||
8301|090|P|basiliximab before having any immunizations/vaccinations. Avoid||
8301|091|P|contact with people who have recently received live vaccines||
8301|092|P|(such as flu vaccine inhaled through the nose).||
8301|093|P|   During pregnancy, this medication should be used only when||
8301|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
8301|095|P|Women who may become pregnant should use effective birth control||
8301|096|P|before beginning treatment with this drug, during use, and for 4||
8301|097|P|months after finishing treatment. Consult your doctor or||
8301|098|P|pharmacist for more information.||
8301|099|P|   It is unknown if this drug passes into breast milk. Consult||
8301|100|P|your doctor before breastfeeding.||
8301|101|B|||
8301|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8301|103|I|medications work or increase your risk for serious side effects.||
8301|104|I|This document does not contain all possible drug interactions.||
8301|105|I|Keep a list of all the products you use (including||
8301|106|I|prescription/nonprescription drugs and herbal products) and share||
8301|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
8301|108|I|the dosage of any medicines without your doctor's approval.||
8301|109|B|||
8301|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8301|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8301|112|O|poison control center right away. US residents can call||
8301|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8301|114|B|||
8301|115|N|NOTES:  Lab and/or medical tests (such as kidney function) should||
8301|116|N|be done while you are using this medication. Keep all medical and||
8301|117|N|lab appointments. Consult your doctor for more details.||
8301|118|B|||
8301|119|D|MISSED DOSE:  It is important to get each dose of this medication||
8301|120|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8301|121|D|right away for a new dosing schedule.||
8301|122|B|||
8301|123|R|STORAGE:  Not applicable. This medication is given in a clinic||
8301|124|R|and will not be stored at home.||
8301|125|B|||
8301|126|M|MEDICAL ALERT:  Your condition can cause complications in a||
8301|127|M|medical emergency. For information about enrolling in MedicAlert,||
8301|128|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8301|129|B|||
8301|130|A|Information last revised May 2025.||
8301|131|A|Copyright(c) 2025 First Databank, Inc.||
8301|132|B|||
8302|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8302|002|Z|does NOT have all possible information about this product. This||
8302|003|Z|information does not assure that this product is safe, effective,||
8302|004|Z|or appropriate for you. This information is not individual||
8302|005|Z|medical advice and does not substitute for the advice of your||
8302|006|Z|health care professional. Always ask your health care||
8302|007|Z|professional for complete information about this product and your||
8302|008|Z|specific health needs.||
8302|009|B|||
8302|010|T|SODIUM POLYSTYRENE SULFONATE POWDER FOR SUSPENSION - ORAL,RECTAL||
8302|011|F|(SOE-dee-um POL-ee-STYE-reen SUL-foe-nate)||
8302|012|B|||
8302|013|C|COMMON BRAND NAME(S): Kayexalate, Kionex, Marlexate||
8302|014|B|||
8302|015|U|USES:  This medication is used to treat a high level of potassium||
8302|016|U|in your blood. Too much potassium in your blood can sometimes||
8302|017|U|cause heart rhythm problems. Sodium polystyrene sulfonate works||
8302|018|U|by helping your body get rid of extra potassium.||
8302|019|B|||
8302|020|H|HOW TO USE:  Take this medication by mouth, or use it rectally as||
8302|021|H|directed by your doctor.||
8302|022|H|   If you are taking this medication by mouth, take it as||
8302|023|H|directed by your doctor, usually 1 to 4 times a day. To prepare||
8302|024|H|the liquid suspension, carefully measure the prescribed dose of||
8302|025|H|the powder and mix it with the prescribed amount of water or||
8302|026|H|flavored syrup as directed. Stir well and drink the entire dose.||
8302|027|H|Stay upright (sitting, standing, or walking) and do not lie down||
8302|028|H|for at least an hour after your dose. Consult your doctor for||
8302|029|H|details.||
8302|030|H|   Sodium polystyrene sulfonate may decrease your absorption of||
8302|031|H|other medications. Take your other medications as directed by||
8302|032|H|your doctor, usually at least 3 hours before or 3 hours after||
8302|033|H|sodium polystyrene sulfonate. Ask your doctor or pharmacist for||
8302|034|H|more information or if you have any questions.||
8302|035|H|   To give this medication rectally as an enema, use the||
8302|036|H|prescribed dose as directed by your doctor, usually every 6 hours||
8302|037|H|as needed. Consult your doctor or pharmacist for directions on||
8302|038|H|how to prepare and mix the dose into a suspension and how to use||
8302|039|H|the enema. Follow instructions for the use of a cleansing enema||
8302|040|H|both before and after your dose of sodium polystyrene sulfonate.||
8302|041|H|The cleansing enema after each rectal dose of this medication||
8302|042|H|should be a non-sodium-containing enema.||
8302|043|H|   Stir the suspension well, and use it soon after mixing. Do not||
8302|044|H|store the mixture for more than 24 hours.||
8302|045|H|   Do not heat this medication because it may not work as well.||
8302|046|H|   The dosage and length of treatment are based on your medical||
8302|047|H|condition and response to treatment. Follow your doctor's||
8302|048|H|instructions carefully. Do not use more of this medication or use||
8302|049|H|it for longer than directed because your potassium blood level||
8302|050|H|may drop too low.||
8302|051|B|||
8302|052|S|SIDE EFFECTS:  Loss of appetite, nausea, vomiting, or||
8302|053|S|constipation may occur. Diarrhea may occur less often. If any of||
8302|054|S|these effects last or get worse, tell your doctor or pharmacist||
8302|055|S|promptly.||
8302|056|S|   To prevent constipation, eat dietary fiber, drink enough||
8302|057|S|water, and exercise. You may also need to take a laxative. Ask||
8302|058|S|your pharmacist which type of laxative is right for you.||
8302|059|S|   Remember that this medication has been prescribed because your||
8302|060|S|doctor has judged that the benefit to you is greater than the||
8302|061|S|risk of side effects. Many people using this medication do not||
8302|062|S|have serious side effects.||
8302|063|S|   Tell your doctor right away if you have any serious side||
8302|064|S|effects, including: muscle weakness/spasms, fast/irregular||
8302|065|S|heartbeat, mental/mood changes (such as irritability, confusion,||
8302|066|S|slowed thinking), swelling hands/ankles/feet.||
8302|067|S|   This medication may cause serious (rarely fatal) intestinal||
8302|068|S|problems (such as bleeding, blockage). Get medical help right||
8302|069|S|away if any of these very serious side effects occur: severe||
8302|070|S|constipation, bloating/swelling/pain in the stomach/abdomen,||
8302|071|S|black/bloody stools, vomit that looks like coffee grounds.||
8302|072|S|   Get medical help right away if you have any very serious side||
8302|073|S|effects, including: inability to move your muscles (paralysis),||
8302|074|S|seizures.||
8302|075|S|   A very serious allergic reaction to this drug is rare.||
8302|076|S|However, get medical help right away if you notice any symptoms||
8302|077|S|of a serious allergic reaction, including: rash, itching/swelling||
8302|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8302|079|S|breathing.||
8302|080|S|   This is not a complete list of possible side effects. If you||
8302|081|S|notice other effects not listed above, contact your doctor or||
8302|082|S|pharmacist.||
8302|083|S|   In the US -||
8302|084|S|   Call your doctor for medical advice about side effects. You||
8302|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8302|086|S|www.fda.gov/medwatch.||
8302|087|S|   In Canada - Call your doctor for medical advice about side||
8302|088|S|effects. You may report side effects to Health Canada at||
8302|089|S|1-866-234-2345.||
8302|090|B|||
8302|091|P|PRECAUTIONS:  Before using sodium polystyrene sulfonate, tell||
8302|092|P|your doctor or pharmacist if you are allergic to it; or if you||
8302|093|P|have any other allergies. This product may contain inactive||
8302|094|P|ingredients, which can cause allergic reactions or other||
8302|095|P|problems. Talk to your pharmacist for more details.||
8302|096|P|   This medication contains a large amount of salt (sodium). Do||
8302|097|P|not use salt substitutes that contain potassium without asking||
8302|098|P|your doctor first. If you have any of these conditions, follow||
8302|099|P|your doctor's instructions for limiting the amount of sodium in||
8302|100|P|your diet: kidney problems, heart failure, high blood pressure,||
8302|101|P|swelling hands/ankles/feet.||
8302|102|P|   Before using this medication, tell your doctor or pharmacist||
8302|103|P|your medical history, especially of: stomach/intestine/bowel||
8302|104|P|problems (such as inflammatory bowel disease, bowel obstruction,||
8302|105|P|chronic constipation, fecal impaction), low level of potassium in||
8302|106|P|the blood.||
8302|107|P|   Before having surgery, tell your doctor or dentist about all||
8302|108|P|the products you use (including prescription drugs,||
8302|109|P|nonprescription drugs, and herbal products).||
8302|110|P|   Older adults may be at greater risk for severe constipation.||
8302|111|P|   This medication must not be given by mouth to newborns,||
8302|112|P|especially premature infants. Also, newborns with slow gut||
8302|113|P|function must not use this drug. Caution is advised when using||
8302|114|P|this medication rectally in newborns and children. They may be||
8302|115|P|more sensitive to the side effects of this drug, especially||
8302|116|P|severe constipation and intestinal problems.||
8302|117|P|   Tell your doctor if you are pregnant before using this||
8302|118|P|medication.||
8302|119|P|   This medication does not pass into breast milk and is unlikely||
8302|120|P|to harm a nursing infant. Consult your doctor before||
8302|121|P|breastfeeding.||
8302|122|B|||
8302|123|I|DRUG INTERACTIONS:  See also How to Use section.||
8302|124|I|   Drug interactions may change how your medications work or||
8302|125|I|increase your risk for serious side effects. This document does||
8302|126|I|not contain all possible drug interactions. Keep a list of all||
8302|127|I|the products you use (including prescription/nonprescription||
8302|128|I|drugs and herbal products) and share it with your doctor and||
8302|129|I|pharmacist. Do not start, stop, or change the dosage of any||
8302|130|I|medicines without your doctor's approval.||
8302|131|I|   Some products that may interact with this drug include:||
8302|132|I|antacids/laxatives that contain aluminum/calcium/magnesium (such||
8302|133|I|as aluminum carbonate, aluminum hydroxide, calcium carbonate,||
8302|134|I|magnesium hydroxide).||
8302|135|I|   Do not use any laxatives that contain sorbitol with this||
8302|136|I|medication. Doing so may increase your risk of intestinal||
8302|137|I|problems. See also Side Effects section.||
8302|138|B|||
8302|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8302|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8302|141|O|poison control center right away. US residents can call||
8302|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8302|143|O|Symptoms of overdose may include: mental/mood changes, muscle||
8302|144|O|weakness, fast/irregular heartbeat, slowed breathing, paralysis.||
8302|145|B|||
8302|146|N|NOTES:  Do not share this medication with others.||
8302|147|N|   Lab and/or medical tests (such as blood levels of potassium||
8302|148|N|and other minerals, EKG) should be done while you are using this||
8302|149|N|medication. Keep all medical and lab appointments. Consult your||
8302|150|N|doctor for more details.||
8302|151|B|||
8302|152|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8302|153|D|If it is near the time of the next dose, skip the missed dose.||
8302|154|D|Use your next dose at the regular time. Do not double the dose to||
8302|155|D|catch up.||
8302|156|B|||
8302|157|R|STORAGE:  Store at room temperature. After mixing, use the||
8302|158|R|suspension within 24 hours. Keep all medications away from||
8302|159|R|children and pets.||
8302|160|R|   Do not flush medications down the toilet or pour them into a||
8302|161|R|drain unless instructed to do so. Properly discard this product||
8302|162|R|when it is expired or no longer needed. Consult your pharmacist||
8302|163|R|or local waste disposal company.||
8302|164|B|||
8302|165|A|Information last revised October 2024.||
8302|166|A|Copyright(c) 2025 First Databank, Inc.||
8302|167|B|||
8304|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8304|002|Z|does NOT have all possible information about this product. This||
8304|003|Z|information does not assure that this product is safe, effective,||
8304|004|Z|or appropriate for you. This information is not individual||
8304|005|Z|medical advice and does not substitute for the advice of your||
8304|006|Z|health care professional. Always ask your health care||
8304|007|Z|professional for complete information about this product and your||
8304|008|Z|specific health needs.||
8304|009|B|||
8304|010|T|LEVALBUTEROL PRE-MIXED SOLUTION - INHALATION||
8304|011|F|(LEV-al-BUE-ter-ol)||
8304|012|B|||
8304|013|C|COMMON BRAND NAME(S): Xopenex||
8304|014|B|||
8304|015|U|USES:  Levalbuterol is used to treat wheezing and shortness of||
8304|016|U|breath that commonly occur with lung problems (such as asthma,||
8304|017|U|chronic obstructive pulmonary disease). It is a quick-relief||
8304|018|U|drug. Controlling these symptoms can decrease time lost from work||
8304|019|U|or school. Levalbuterol belongs to a class of drugs known as||
8304|020|U|bronchodilators. It works by relaxing the muscles around the||
8304|021|U|airways so that they open up and you can breathe more easily.||
8304|022|B|||
8304|023|H|HOW TO USE:  Read the Patient Information Leaflet available from||
8304|024|H|your pharmacist before you start using this medication and each||
8304|025|H|time you get a refill. This product is used with a special||
8304|026|H|machine called a nebulizer that changes the solution to a fine||
8304|027|H|mist that you breathe in. Consult your doctor, pharmacist, or||
8304|028|H|respiratory therapist on how to inhale this medication properly||
8304|029|H|with this equipment. If a child is using this equipment, a parent||
8304|030|H|or other responsible adult should supervise the child.||
8304|031|H|   This product should be clear and colorless. Before using,||
8304|032|H|check this product for particles or discoloration. If either is||
8304|033|H|present, do not use the liquid.||
8304|034|H|   This product does not require any mixing before use unless||
8304|035|H|your doctor instructs you otherwise. This medication is inhaled||
8304|036|H|into the lungs using a nebulizer as directed by your doctor,||
8304|037|H|usually 3 times a day. Each treatment usually takes about 5 to 15||
8304|038|H|minutes. Use this medication only through a nebulizer. Do not||
8304|039|H|swallow or inject the solution. Do not mix with other medications||
8304|040|H|in the nebulizer. To prevent infections, clean the nebulizer and||
8304|041|H|mouthpiece/face mask according to the manufacturer's directions.||
8304|042|H|   Dosage is based on your medical condition, age, and response||
8304|043|H|to treatment. Do not increase your dose or use this drug more||
8304|044|H|often than prescribed without your doctor's approval. Using too||
8304|045|H|much of this medication will increase your risk of serious||
8304|046|H|(possibly fatal) side effects.||
8304|047|H|   Learn which of your inhalers/medications you should use every||
8304|048|H|day (controller drugs) and which you should use if your breathing||
8304|049|H|suddenly worsens (quick-relief drugs). Ask your doctor ahead of||
8304|050|H|time what you should do if you have new or worsening cough or||
8304|051|H|shortness of breath, wheezing, increased sputum, worsening peak||
8304|052|H|flow meter readings, waking up at night with trouble breathing,||
8304|053|H|if you use your quick-relief inhaler/medication more often (more||
8304|054|H|than 2 days a week), or if your quick-relief inhaler/medication||
8304|055|H|does not seem to be working well. Learn when you can treat sudden||
8304|056|H|breathing problems by yourself and when you must get medical help||
8304|057|H|right away.||
8304|058|H|   Tell your doctor if your symptoms do not get better or if they||
8304|059|H|get worse.||
8304|060|B|||
8304|061|S|SIDE EFFECTS:  Headache, nervousness, shaking (tremor),||
8304|062|S|dizziness, trouble sleeping, dry mouth, nausea, stomach upset,||
8304|063|S|diarrhea, or runny nose may occur. If any of these effects last||
8304|064|S|or get worse, tell your doctor or pharmacist promptly.||
8304|065|S|   Remember that this medication has been prescribed because your||
8304|066|S|doctor has judged that the benefit to you is greater than the||
8304|067|S|risk of side effects. Many people using this medication do not||
8304|068|S|have serious side effects.||
8304|069|S|   This medication may raise your blood pressure. Check your||
8304|070|S|blood pressure regularly and tell your doctor if the results are||
8304|071|S|high.||
8304|072|S|   Tell your doctor right away if you have any serious side||
8304|073|S|effects, including: fast/pounding heartbeat.||
8304|074|S|   Get medical help right away if you have any very serious side||
8304|075|S|effects, including: irregular heartbeat, chest pain, rapid||
8304|076|S|breathing, confusion.||
8304|077|S|   Rarely, this medication has caused severe (rarely fatal),||
8304|078|S|sudden worsening of breathing problems/asthma (paradoxical||
8304|079|S|bronchospasm). If you experience sudden wheezing, get medical||
8304|080|S|help right away.||
8304|081|S|   A very serious allergic reaction to this drug is rare.||
8304|082|S|However, get medical help right away if you notice any symptoms||
8304|083|S|of a serious allergic reaction, including: rash, itching/swelling||
8304|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8304|085|S|breathing.||
8304|086|S|   This is not a complete list of possible side effects. If you||
8304|087|S|notice other effects not listed above, contact your doctor or||
8304|088|S|pharmacist.||
8304|089|S|   In the US -||
8304|090|S|   Call your doctor for medical advice about side effects. You||
8304|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8304|092|S|www.fda.gov/medwatch.||
8304|093|S|   In Canada - Call your doctor for medical advice about side||
8304|094|S|effects. You may report side effects to Health Canada at||
8304|095|S|1-866-234-2345.||
8304|096|B|||
8304|097|P|PRECAUTIONS:  Before using levalbuterol, tell your doctor or||
8304|098|P|pharmacist if you are allergic to it; or to similar||
8304|099|P|bronchodilators (such as albuterol, metaproterenol, salmeterol);||
8304|100|P|or to sympathomimetic drugs (such as epinephrine,||
8304|101|P|pseudoephedrine); or if you have any other allergies. This||
8304|102|P|product may contain inactive ingredients, which can cause||
8304|103|P|allergic reactions or other problems. Talk to your pharmacist for||
8304|104|P|more details.||
8304|105|P|   Before using this medication, tell your doctor or pharmacist||
8304|106|P|your medical history, especially of: heart disease (such as||
8304|107|P|irregular heartbeat, angina, heart attack), high blood pressure,||
8304|108|P|seizures, diabetes.||
8304|109|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8304|110|P|can make you more dizzy. Do not drive, use machinery, or do||
8304|111|P|anything that needs alertness until you can do it safely. Limit||
8304|112|P|alcoholic beverages. Talk to your doctor if you are using||
8304|113|P|marijuana (cannabis).||
8304|114|P|   Before having surgery, tell your doctor or dentist about all||
8304|115|P|the products you use (including prescription drugs,||
8304|116|P|nonprescription drugs, and herbal products).||
8304|117|P|   During pregnancy, this medication should be used only when||
8304|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
8304|119|P|   It is unknown if this drug passes into breast milk. Consult||
8304|120|P|your doctor before breastfeeding.||
8304|121|B|||
8304|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8304|123|I|medications work or increase your risk for serious side effects.||
8304|124|I|This document does not contain all possible drug interactions.||
8304|125|I|Keep a list of all the products you use (including||
8304|126|I|prescription/nonprescription drugs and herbal products) and share||
8304|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
8304|128|I|the dosage of any medicines without your doctor's approval.||
8304|129|I|   Levalbuterol is very similar to albuterol. Do not use inhaled||
8304|130|I|medications containing albuterol while using levalbuterol.||
8304|131|B|||
8304|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8304|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8304|134|O|poison control center right away. US residents can call||
8304|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8304|136|O|Symptoms of overdose may include: chest pain,||
8304|137|O|fast/pounding/irregular heartbeat, headache, shaking (tremors),||
8304|138|O|nervousness, weakness, severe dizziness, seizures.||
8304|139|B|||
8304|140|N|NOTES:  Do not share this medication with others.||
8304|141|N|   Avoid allergens, irritants, smoking and other factors that||
8304|142|N|make asthma worse.||
8304|143|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
8304|144|N|EKG) may be done while you are using this medication. Keep all||
8304|145|N|medical and lab appointments. Consult your doctor for more||
8304|146|N|details.||
8304|147|N|   Learn to use a peak flow meter, use it daily, and promptly||
8304|148|N|report worsening asthma (such as readings in the yellow/red range||
8304|149|N|or increased use of quick-relief inhalers).||
8304|150|B|||
8304|151|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8304|152|D|If it is near the time of the next dose, skip the missed dose.||
8304|153|D|Use your next dose at the regular time. Do not double the dose to||
8304|154|D|catch up.||
8304|155|B|||
8304|156|R|STORAGE:  Store at room temperature away from light and heat.||
8304|157|R|Keep vials in the foil pouch until ready to use. Once the foil||
8304|158|R|pouch is opened, this medication expires after 2 weeks. If the||
8304|159|R|vials are removed from the foil pouch and not used right away,||
8304|160|R|protect it from light and use within 1 week. Keep all medications||
8304|161|R|away from children and pets.||
8304|162|R|   Do not flush medications down the toilet or pour them into a||
8304|163|R|drain unless instructed to do so. Properly discard this product||
8304|164|R|when it is expired or no longer needed. Consult your pharmacist||
8304|165|R|or local waste disposal company.||
8304|166|B|||
8304|167|M|MEDICAL ALERT:  Your condition can cause complications in a||
8304|168|M|medical emergency. For information about enrolling in MedicAlert,||
8304|169|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8304|170|B|||
8304|171|A|Information last revised May 2025.||
8304|172|A|Copyright(c) 2025 First Databank, Inc.||
8304|173|B|||
8306|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8306|002|Z|does NOT have all possible information about this product. This||
8306|003|Z|information does not assure that this product is safe, effective,||
8306|004|Z|or appropriate for you. This information is not individual||
8306|005|Z|medical advice and does not substitute for the advice of your||
8306|006|Z|health care professional. Always ask your health care||
8306|007|Z|professional for complete information about this product and your||
8306|008|Z|specific health needs.||
8306|009|B|||
8306|010|T|HYOSCINE (SCOPOLAMINE) - INJECTION||
8306|011|F|(HYE-oh-seen skoe-POL-a-meen)||
8306|012|B|||
8306|013|U|USES:  Hyoscine (also known as scopolamine) is used to treat||
8306|014|U|cramps (spasms) of the stomach, intestines, kidneys, and bladder.||
8306|015|U|It helps to relieve discomfort caused by conditions such as||
8306|016|U|irritable bowel syndrome, gallstones, kidney stones, and||
8306|017|U|overactive bladder. It works by slowing down the natural||
8306|018|U|movements of the gut and by relaxing the muscles in these parts||
8306|019|U|of the body. Hyoscine may also be used before certain medical||
8306|020|U|procedures (such as endoscopy) when it is necessary to relax the||
8306|021|U|smooth muscle of the stomach and intestines (gastrointestinal||
8306|022|U|tract). This medication is a belladonna alkaloid. It belongs to||
8306|023|U|the class of drugs known as antispasmodics. This injectable form||
8306|024|U|of hyoscine is used when the same drug cannot be taken by mouth||
8306|025|U|or when a very fast response is needed.||
8306|026|B|||
8306|027|H|HOW TO USE:  This medication is given by injection into a vein or||
8306|028|H|muscle or under the skin by a health care professional as||
8306|029|H|directed by your doctor. The dosage is based on your medical||
8306|030|H|condition and response to treatment.||
8306|031|H|   Tell your doctor if your condition lasts or gets worse.||
8306|032|B|||
8306|033|S|SIDE EFFECTS:  Dry mouth, nausea, decreased sweating, flushing,||
8306|034|S|blurred vision, constipation, dizziness, drowsiness, or||
8306|035|S|redness/burning/pain at the injection site may occur. If any of||
8306|036|S|these effects last or get worse, tell your doctor or pharmacist||
8306|037|S|promptly.||
8306|038|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
8306|039|S|chips, chew (sugarless) gum, drink water, or use a saliva||
8306|040|S|substitute.||
8306|041|S|   Remember that this medication has been prescribed because your||
8306|042|S|doctor has judged that the benefit to you is greater than the||
8306|043|S|risk of side effects. Many people using this medication do not||
8306|044|S|have serious side effects.||
8306|045|S|   Tell your doctor right away if you have any serious side||
8306|046|S|effects, including: shortness of breath, trouble urinating,||
8306|047|S|fast/irregular heartbeat, mental/mood changes (such as||
8306|048|S|confusion).||
8306|049|S|   This medication may increase the pressure inside the eyes of||
8306|050|S|people with a certain type of eye disease (narrow-angle glaucoma)||
8306|051|S|or those at risk for it. Get medical help right away if any of||
8306|052|S|these rare but very serious side effects occur: vision problems||
8306|053|S|(such as loss of vision), eye pain.||
8306|054|S|   A very serious allergic reaction to this drug is rare.||
8306|055|S|However, get medical help right away if you notice any symptoms||
8306|056|S|of a serious allergic reaction, including: rash, itching/swelling||
8306|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8306|058|S|breathing.||
8306|059|S|   This is not a complete list of possible side effects. If you||
8306|060|S|notice other effects not listed above, contact your doctor or||
8306|061|S|pharmacist.||
8306|062|S|   In the US -||
8306|063|S|   Call your doctor for medical advice about side effects. You||
8306|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8306|065|S|www.fda.gov/medwatch.||
8306|066|S|   In Canada - Call your doctor for medical advice about side||
8306|067|S|effects. You may report side effects to Health Canada at||
8306|068|S|1-866-234-2345.||
8306|069|B|||
8306|070|P|PRECAUTIONS:  Before using hyoscine, tell your doctor or||
8306|071|P|pharmacist if you are allergic to it; or to other belladonna||
8306|072|P|alkaloids (such as atropine, hyoscyamine); or if you have any||
8306|073|P|other allergies. This product may contain inactive ingredients,||
8306|074|P|which can cause allergic reactions or other problems. Talk to||
8306|075|P|your pharmacist for more details.||
8306|076|P|   Before using this medication, tell your doctor or pharmacist||
8306|077|P|your medical history, especially of: myasthenia gravis, glaucoma,||
8306|078|P|trouble urinating (for example, due to enlarged prostate),||
8306|079|P|certain heart problems (angina, fast/irregular heartbeat, heart||
8306|080|P|failure, mitral valve stenosis), other stomach/intestinal||
8306|081|P|problems (such as slow gut, blockage, megacolon, infection,||
8306|082|P|ulcerative colitis), high blood pressure, overactive thyroid||
8306|083|P|(hyperthyroidism), kidney disease, liver disease, heartburn||
8306|084|P|problems (such as acid reflux, hiatal hernia).||
8306|085|P|   This drug may make you dizzy or drowsy or blur your vision.||
8306|086|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8306|087|P|drowsy. Do not drive, use machinery, or do anything that needs||
8306|088|P|alertness or clear vision until you can do it safely. Limit||
8306|089|P|alcoholic beverages. Talk to your doctor if you are using||
8306|090|P|marijuana (cannabis).||
8306|091|P|   This drug may make you sweat less, making you more likely to||
8306|092|P|get heat stroke. Avoid doing things that may cause you to||
8306|093|P|overheat, such as hard work or exercise in hot weather, or using||
8306|094|P|hot tubs. When the weather is hot, drink a lot of fluids and||
8306|095|P|dress lightly. If you overheat, quickly look for a place to cool||
8306|096|P|down and rest. Get medical help right away if you have a fever||
8306|097|P|that does not go away, mental/mood changes, headache, or||
8306|098|P|dizziness.||
8306|099|P|   Older adults may be more sensitive to the side effects of this||
8306|100|P|drug, especially dizziness, drowsiness, dry mouth, trouble||
8306|101|P|urinating, or eye problems.||
8306|102|P|   During pregnancy, this medication should be used only when||
8306|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
8306|104|P|   This drug passes into breast milk. Consult your doctor before||
8306|105|P|breastfeeding.||
8306|106|B|||
8306|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8306|108|I|medications work or increase your risk for serious side effects.||
8306|109|I|This document does not contain all possible drug interactions.||
8306|110|I|Keep a list of all the products you use (including||
8306|111|I|prescription/nonprescription drugs and herbal products) and share||
8306|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
8306|113|I|the dosage of any medicines without your doctor's approval.||
8306|114|I|   Some products that may interact with this drug include:||
8306|115|I|pramlintide, potassium tablets/capsules.||
8306|116|I|   Tell your doctor or pharmacist if you are using other products||
8306|117|I|that cause drowsiness such as opioid pain or cough relievers||
8306|118|I|(such as codeine, hydrocodone), alcohol, marijuana (cannabis),||
8306|119|I|drugs for sleep or anxiety (such as alprazolam, lorazepam,||
8306|120|I|zolpidem), muscle relaxants (such as carisoprodol,||
8306|121|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8306|122|I|diphenhydramine).||
8306|123|I|   Check the labels on all your medicines (such as allergy or||
8306|124|I|cough-and-cold products) because they may contain ingredients||
8306|125|I|that cause drowsiness or cause your heart to beat faster. Ask||
8306|126|I|your pharmacist about using those products safely.||
8306|127|I|   This medication may interfere with certain lab tests (such as||
8306|128|I|gastric secretion test), possibly causing false test results.||
8306|129|I|Make sure lab personnel and all your doctors know you use this||
8306|130|I|drug.||
8306|131|B|||
8306|132|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8306|133|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8306|134|O|poison control center right away. US residents can call||
8306|135|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8306|136|O|Symptoms of overdose may include: extreme drowsiness, mental/mood||
8306|137|O|changes, fever, fast/irregular heartbeat, dry/hot/red skin,||
8306|138|O|trouble breathing, seizures.||
8306|139|B|||
8306|140|N|NOTES:  Not applicable.||
8306|141|B|||
8306|142|D|MISSED DOSE:  It is important to get each dose of this medication||
8306|143|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8306|144|D|right away for a new dosing schedule.||
8306|145|B|||
8306|146|R|STORAGE:  Not applicable. This medication is given in a clinic||
8306|147|R|and will not be stored at home.||
8306|148|B|||
8306|149|A|Information last revised October 2025.||
8306|150|A|Copyright(c) 2025 First Databank, Inc.||
8306|151|B|||
8309|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8309|002|Z|does NOT have all possible information about this product. This||
8309|003|Z|information does not assure that this product is safe, effective,||
8309|004|Z|or appropriate for you. This information is not individual||
8309|005|Z|medical advice and does not substitute for the advice of your||
8309|006|Z|health care professional. Always ask your health care||
8309|007|Z|professional for complete information about this product and your||
8309|008|Z|specific health needs.||
8309|009|B|||
8309|010|T|GLYBURIDE/METFORMIN - ORAL||
8309|011|F|(GLYE-bure-ide/met-FOR-min)||
8309|012|B|||
8309|013|C|COMMON BRAND NAME(S): Glucovance||
8309|014|B|||
8309|015|W|WARNING:  Rarely, too much metformin can build up in the body and||
8309|016|W|cause a serious (sometimes fatal) condition called lactic||
8309|017|W|acidosis. Lactic acidosis is more likely if you are an older||
8309|018|W|adult, if you have kidney or liver disease, dehydration, heart||
8309|019|W|failure, heavy alcohol use, if you have surgery, if you have||
8309|020|W|X-ray or scanning procedures that use iodinated contrast, or if||
8309|021|W|you are using certain drugs. For some conditions, your doctor may||
8309|022|W|tell you to stop taking this medication for a short time. Ask||
8309|023|W|your doctor or pharmacist for more details.||
8309|024|W|   Stop taking this medication and get medical help right away if||
8309|025|W|you have any symptoms of lactic acidosis, such as unusual||
8309|026|W|tiredness, dizziness, severe drowsiness, chills, blue/cold skin,||
8309|027|W|muscle pain, fast/difficult breathing, slow/irregular heartbeat,||
8309|028|W|or stomach pain with nausea/vomiting/diarrhea.||
8309|029|B|||
8309|030|U|USES:  This combination medication is used with a proper diet and||
8309|031|U|exercise program to control high blood sugar in people with type||
8309|032|U|2 diabetes. It may also be used with other diabetes medications.||
8309|033|U|   This product contains 2 medications. Glyburide belongs to the||
8309|034|U|class of drugs known as sulfonylureas. It lowers blood sugar by||
8309|035|U|causing the release of your body's natural insulin and by||
8309|036|U|decreasing the amount of sugar that your liver makes. Metformin||
8309|037|U|works by decreasing the amount of sugar that your liver makes and||
8309|038|U|that your stomach/intestines absorb. Both of these medications||
8309|039|U|work by helping to restore your body's proper response to the||
8309|040|U|insulin you naturally produce.||
8309|041|U|   Controlling high blood sugar helps prevent kidney damage,||
8309|042|U|blindness, nerve problems, loss of limbs, and sexual function||
8309|043|U|problems. Proper control of diabetes may also lessen your risk of||
8309|044|U|a heart attack or stroke.||
8309|045|B|||
8309|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8309|047|H|from your pharmacist before you start taking this medication and||
8309|048|H|each time you get a refill. If you have any questions, ask your||
8309|049|H|doctor or pharmacist.||
8309|050|H|   Take this medication by mouth with meals as directed by your||
8309|051|H|doctor, usually once or twice a day. Drink plenty of fluids while||
8309|052|H|taking this medication unless otherwise directed by your doctor.||
8309|053|H|   The dosage is based on your medical condition and response to||
8309|054|H|treatment. To reduce your risk of side effects (such as upset||
8309|055|H|stomach and low blood sugar), your doctor may direct you to start||
8309|056|H|this medication at a low dose and gradually increase your dose.||
8309|057|H|Your doctor will adjust your dose based on your blood sugar to||
8309|058|H|find the best dose for you. Follow your doctor's instructions||
8309|059|H|carefully.||
8309|060|H|   If you are also taking colesevelam, take glyburide/metformin||
8309|061|H|at least 4 hours before colesevelam.||
8309|062|H|   Use this medication regularly to get the most benefit from it.||
8309|063|H|To help you remember, take it at the same time(s) each day.||
8309|064|H|   It may take up to 2 weeks before you get the full benefit of||
8309|065|H|this drug. Tell your doctor if your condition does not get better||
8309|066|H|or if it gets worse (your blood sugar is too high or too low).||
8309|067|B|||
8309|068|S|SIDE EFFECTS:  See also Warning section.||
8309|069|S|   Nausea, stomach upset, diarrhea, or weight gain may occur. If||
8309|070|S|any of these effects last or get worse, tell your doctor or||
8309|071|S|pharmacist promptly. If stomach symptoms return later (after you||
8309|072|S|are on the same dose for several days or weeks), tell your doctor||
8309|073|S|right away. Stomach symptoms that occur after the first days of||
8309|074|S|your treatment may be a sign of lactic acidosis.||
8309|075|S|   Remember that this medication has been prescribed because your||
8309|076|S|doctor has judged that the benefit to you is greater than the||
8309|077|S|risk of side effects. Many people using this medication do not||
8309|078|S|have serious side effects.||
8309|079|S|   Tell your doctor right away if you have any serious side||
8309|080|S|effects, including: nausea that doesn't stop, easy||
8309|081|S|bleeding/bruising, signs of infection (such as sore throat that||
8309|082|S|doesn't go away, fever, chills), severe stomach/abdominal pain,||
8309|083|S|yellowing eyes/skin, dark urine.||
8309|084|S|   This medication can cause low blood sugar (hypoglycemia). This||
8309|085|S|may occur if you do not get enough calories from food or if you||
8309|086|S|do unusually heavy exercise. Symptoms of low blood sugar include||
8309|087|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
8309|088|S|dizziness, or tingling hands/feet. It is a good habit to carry||
8309|089|S|glucose tablets or gel to treat low blood sugar. If you don't||
8309|090|S|have these reliable forms of glucose, rapidly raise your blood||
8309|091|S|sugar by eating a quick source of sugar such as table sugar,||
8309|092|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
8309|093|S|doctor right away about the reaction and the use of this product.||
8309|094|S|To help prevent low blood sugar, eat meals on a regular schedule,||
8309|095|S|and do not skip meals. Check with your doctor or pharmacist to||
8309|096|S|find out what you should do if you miss a meal.||
8309|097|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
8309|098|S|thirst/urination. If these symptoms occur, tell your doctor right||
8309|099|S|away. Your doctor may need to adjust your diabetes medication,||
8309|100|S|exercise program, or diet.||
8309|101|S|   A very serious allergic reaction to this drug is rare.||
8309|102|S|However, get medical help right away if you notice any symptoms||
8309|103|S|of a serious allergic reaction, including: rash, itching/swelling||
8309|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8309|105|S|breathing.||
8309|106|S|   This is not a complete list of possible side effects. If you||
8309|107|S|notice other effects not listed above, contact your doctor or||
8309|108|S|pharmacist.||
8309|109|S|   In the US -||
8309|110|S|   Call your doctor for medical advice about side effects. You||
8309|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8309|112|S|www.fda.gov/medwatch.||
8309|113|S|   In Canada - Call your doctor for medical advice about side||
8309|114|S|effects. You may report side effects to Health Canada at||
8309|115|S|1-866-234-2345.||
8309|116|B|||
8309|117|P|PRECAUTIONS:  See also Warning section.||
8309|118|P|   Before taking this medication, tell your doctor or pharmacist||
8309|119|P|if you are allergic to glyburide or metformin; or if you have any||
8309|120|P|other allergies. This product may contain inactive ingredients,||
8309|121|P|which can cause allergic reactions or other problems. Talk to||
8309|122|P|your pharmacist for more details.||
8309|123|P|   Before using this medication, tell your doctor or pharmacist||
8309|124|P|your medical history, especially of: kidney disease, liver||
8309|125|P|disease, heart disease (such as heart failure, recent heart||
8309|126|P|attack), serious infection, dehydration, alcohol use, breathing||
8309|127|P|problems (such as obstructive lung disease, asthma), blood||
8309|128|P|problems (such as anemia, vitamin B12 deficiency), electrolyte||
8309|129|P|imbalance (hyponatremia), fertility problems (such as ovulation||
8309|130|P|problems), certain hormonal conditions (adrenal/pituitary||
8309|131|P|insufficiency, thyroid disease, syndrome of inappropriate||
8309|132|P|antidiuretic hormone-SIADH), a certain nervous system problem||
8309|133|P|(autonomic neuropathy).||
8309|134|P|   Before having surgery or any X-ray/scanning procedure using||
8309|135|P|iodinated contrast, tell your doctor or dentist about all the||
8309|136|P|products you use (including prescription drugs, nonprescription||
8309|137|P|drugs, and herbal products). You may need to stop this medication||
8309|138|P|for a short time for the surgery/procedure. Ask your doctor or||
8309|139|P|dentist for instructions before your surgery/procedure.||
8309|140|P|   You may experience blurred vision, dizziness, or drowsiness||
8309|141|P|due to extremely low or high blood sugar. Do not drive, use||
8309|142|P|machinery, or do anything that needs alertness or clear vision||
8309|143|P|until you can do it safely.||
8309|144|P|   Limit alcohol while taking this medication because it can||
8309|145|P|increase the risk of developing low blood sugar and lactic||
8309|146|P|acidosis. Rarely, alcohol can interact with glyburide and cause a||
8309|147|P|serious reaction (disulfiram-like reaction) with symptoms such as||
8309|148|P|facial flushing, nausea, vomiting, dizziness, or stomach pain.||
8309|149|P|Consult your doctor or pharmacist about using alcohol safely.||
8309|150|P|   It may be harder to control your blood sugar when your body is||
8309|151|P|stressed (such as due to fever, infection, injury, or surgery).||
8309|152|P|Consult your doctor because this may require a change in your||
8309|153|P|treatment plan, medications, or blood sugar testing.||
8309|154|P|   This medication may make you more sensitive to the sun. Limit||
8309|155|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8309|156|P|sunscreen and wear protective clothing when outdoors. Tell your||
8309|157|P|doctor right away if you get sunburned or have skin||
8309|158|P|blisters/redness.||
8309|159|P|   Older adults may be more sensitive to the side effects of this||
8309|160|P|drug, especially lactic acidosis or low blood sugar.||
8309|161|P|   This medication can cause changes in the menstrual cycle||
8309|162|P|(promote ovulation) and increase the risk of becoming pregnant.||
8309|163|P|Consult your doctor or pharmacist about the use of reliable birth||
8309|164|P|control while using this medication.||
8309|165|P|   During pregnancy, this medication should be used only when||
8309|166|P|clearly needed. Discuss the risks and benefits with your doctor.||
8309|167|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
8309|168|P|your doctor for managing your blood sugar while pregnant. Your||
8309|169|P|doctor may change your diabetes treatment during your pregnancy||
8309|170|P|(such as diet and medications including insulin).||
8309|171|P|   It is unknown if glyburide passes into breast milk. Metformin||
8309|172|P|passes into breast milk. Consult your doctor before||
8309|173|P|breastfeeding.||
8309|174|B|||
8309|175|I|DRUG INTERACTIONS:  See also How To Use section.||
8309|176|I|   Drug interactions may change how your medications work or||
8309|177|I|increase your risk for serious side effects. This document does||
8309|178|I|not contain all possible drug interactions. Keep a list of all||
8309|179|I|the products you use (including prescription/nonprescription||
8309|180|I|drugs and herbal products) and share it with your doctor and||
8309|181|I|pharmacist. Do not start, stop, or change the dosage of any||
8309|182|I|medicines without your doctor's approval.||
8309|183|I|   A product that may interact with this drug is: bosentan.||
8309|184|I|   Many drugs can affect your blood sugar, making it harder to||
8309|185|I|control. Before you start, stop, or change any medication, talk||
8309|186|I|with your doctor or pharmacist about how the medication may||
8309|187|I|affect your blood sugar. Check your blood sugar regularly as||
8309|188|I|directed and share the results with your doctor. Tell your doctor||
8309|189|I|right away if you have symptoms of high or low blood sugar. (See||
8309|190|I|also Side Effects section.) Your doctor may need to adjust your||
8309|191|I|diabetes medication, exercise program, or diet.||
8309|192|I|   Beta-blocker medications (including metoprolol, propranolol,||
8309|193|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
8309|194|I|heartbeat you would usually feel when your blood sugar falls too||
8309|195|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
8309|196|I|dizziness, hunger, or sweating are unaffected by these drugs.||
8309|197|B|||
8309|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8309|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8309|200|O|poison control center right away. US residents can call||
8309|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8309|202|O|Symptoms of overdose may include: rapid breathing, severe||
8309|203|O|drowsiness, slow/irregular heartbeat.||
8309|204|B|||
8309|205|N|NOTES:  Do not share this medication with others.||
8309|206|N|   Attend a diabetes education program to learn more about how to||
8309|207|N|manage your diabetes with medications, diet, exercise, and||
8309|208|N|regular medical exams.||
8309|209|N|   Learn the symptoms of high and low blood sugar and how to||
8309|210|N|treat low blood sugar. Check your blood sugar regularly as||
8309|211|N|directed.||
8309|212|N|   Lab and/or medical tests (such as kidney/liver function, blood||
8309|213|N|sugar, hemoglobin A1c, complete blood counts) should be done||
8309|214|N|before you start taking this medication and while you are taking||
8309|215|N|it. Keep all medical and lab appointments. Consult your doctor||
8309|216|N|for more details.||
8309|217|B|||
8309|218|D|MISSED DOSE:  If you miss a dose, take it with a meal as soon as||
8309|219|D|you remember. If it is near the time of the next dose, skip the||
8309|220|D|missed dose. Take your next dose at the regular time. Do not||
8309|221|D|double the dose to catch up.||
8309|222|B|||
8309|223|R|STORAGE:  Store at room temperature away from light and moisture.||
8309|224|R|Do not store in the bathroom. Keep all medications away from||
8309|225|R|children and pets.||
8309|226|R|   Do not flush medications down the toilet or pour them into a||
8309|227|R|drain unless instructed to do so. Properly discard this product||
8309|228|R|when it is expired or no longer needed. Consult your pharmacist||
8309|229|R|or local waste disposal company.||
8309|230|B|||
8309|231|M|MEDICAL ALERT:  Your condition can cause complications in a||
8309|232|M|medical emergency. For information about enrolling in MedicAlert,||
8309|233|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8309|234|B|||
8309|235|A|Information last revised November 2025.||
8309|236|A|Copyright(c) 2025 First Databank, Inc.||
8309|237|B|||
8310|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8310|002|Z|does NOT have all possible information about this product. This||
8310|003|Z|information does not assure that this product is safe, effective,||
8310|004|Z|or appropriate for you. This information is not individual||
8310|005|Z|medical advice and does not substitute for the advice of your||
8310|006|Z|health care professional. Always ask your health care||
8310|007|Z|professional for complete information about this product and your||
8310|008|Z|specific health needs.||
8310|009|B|||
8310|010|T|ALENDRONATE WEEKLY - ORAL||
8310|011|F|(a-LEN-droe-nate)||
8310|012|B|||
8310|013|C|COMMON BRAND NAME(S): Fosamax||
8310|014|B|||
8310|015|U|USES:  Alendronate is used to prevent and treat certain types of||
8310|016|U|bone loss (osteoporosis) in adults. Osteoporosis causes bones to||
8310|017|U|become thinner and break more easily. Your chance of developing||
8310|018|U|osteoporosis increases as you age, after menopause, or if you are||
8310|019|U|taking corticosteroid medications (such as prednisone) for a long||
8310|020|U|time.||
8310|021|U|   This medication works by slowing bone loss. This effect helps||
8310|022|U|maintain strong bones and reduce the risk of broken bones||
8310|023|U|(fractures). Alendronate belongs to a class of drugs called||
8310|024|U|bisphosphonates.||
8310|025|B|||
8310|026|H|HOW TO USE:  Read the Medication Guide provided by your||
8310|027|H|pharmacist before you start taking alendronate and each time you||
8310|028|H|get a refill. Follow the instructions very closely to make sure||
8310|029|H|your body absorbs as much drug as possible and to reduce the risk||
8310|030|H|of injury to your esophagus. If you have any questions, ask your||
8310|031|H|doctor or pharmacist.||
8310|032|H|   Take this medication by mouth as directed by your doctor,||
8310|033|H|usually once a week. Choose the day of the week that best fits||
8310|034|H|your schedule and take it on that day each week.||
8310|035|H|   Take this medication after getting up for the day and before||
8310|036|H|taking your first food, beverage, or other medication. Take it||
8310|037|H|with a full glass (6-8 ounces or 180-240 milliliters) of plain||
8310|038|H|water. Swallow the tablet whole. Do not chew or suck on it. Then||
8310|039|H|stay fully upright (sitting, standing, or walking) for at least||
8310|040|H|30 minutes and do not lie down until after your first food of the||
8310|041|H|day. Alendronate works only if taken on an empty stomach. Wait at||
8310|042|H|least 30 minutes (preferably 1 to 2 hours) after taking the||
8310|043|H|medication before you eat or drink anything other than plain||
8310|044|H|water.||
8310|045|H|   Do not take this medication at bedtime or before rising for||
8310|046|H|the day. It may not be absorbed and you may have side effects.||
8310|047|H|   Calcium or iron supplements, vitamins, antacids, coffee, tea,||
8310|048|H|soda, mineral water, juice with added calcium, and food can||
8310|049|H|decrease the absorption of alendronate. Do not take these for at||
8310|050|H|least 30 minutes (preferably 1 to 2 hours) after taking||
8310|051|H|alendronate.||
8310|052|H|   Take this medication regularly to get the most benefit from||
8310|053|H|it. To help you remember, take it on the same day each week. Mark||
8310|054|H|your calendar with a reminder. Talk to your doctor about the||
8310|055|H|risks and benefits of long-term use of this medication.||
8310|056|B|||
8310|057|S|SIDE EFFECTS:  Stomach pain, constipation, diarrhea, gas, or||
8310|058|S|nausea may occur. If any of these effects last or get worse, tell||
8310|059|S|your doctor or pharmacist promptly.||
8310|060|S|   Remember that this medication has been prescribed because your||
8310|061|S|doctor has judged that the benefit to you is greater than the||
8310|062|S|risk of side effects. Many people using this medication do not||
8310|063|S|have serious side effects.||
8310|064|S|   Tell your doctor right away if you have any serious side||
8310|065|S|effects, including: jaw/ear pain, swelling of||
8310|066|S|joints/hands/ankles/feet, increased or severe bone/joint/muscle||
8310|067|S|pain, new or unusual hip/thigh/groin pain, black/tarry stools,||
8310|068|S|vomit that looks like coffee grounds.||
8310|069|S|   This medication may rarely cause serious irritation and ulcers||
8310|070|S|of the esophagus. If you notice any of the following unlikely but||
8310|071|S|very serious side effects, stop taking alendronate and talk to||
8310|072|S|your doctor or pharmacist right away: new or worsening heartburn,||
8310|073|S|chest pain, pain or difficulty when swallowing.||
8310|074|S|   A very serious allergic reaction to this drug is rare.||
8310|075|S|However, get medical help right away if you notice any symptoms||
8310|076|S|of a serious allergic reaction, including: rash, itching/swelling||
8310|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8310|078|S|breathing.||
8310|079|S|   This is not a complete list of possible side effects. If you||
8310|080|S|notice other effects not listed above, contact your doctor or||
8310|081|S|pharmacist.||
8310|082|S|   In the US -||
8310|083|S|   Call your doctor for medical advice about side effects. You||
8310|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8310|085|S|www.fda.gov/medwatch.||
8310|086|S|   In Canada - Call your doctor for medical advice about side||
8310|087|S|effects. You may report side effects to Health Canada at||
8310|088|S|1-866-234-2345.||
8310|089|B|||
8310|090|P|PRECAUTIONS:  Before taking alendronate, tell your doctor or||
8310|091|P|pharmacist if you are allergic to it; or to other||
8310|092|P|bisphosphonates; or if you have any other allergies. This product||
8310|093|P|may contain inactive ingredients, which can cause allergic||
8310|094|P|reactions or other problems. Talk to your pharmacist for more||
8310|095|P|details.||
8310|096|P|   Before using this medication, tell your doctor or pharmacist||
8310|097|P|your medical history, especially of: disorders of the esophagus||
8310|098|P|(such as esophageal stricture or achalasia), trouble swallowing,||
8310|099|P|trouble standing or sitting upright for at least 30 minutes, low||
8310|100|P|calcium levels, kidney problems, stomach/intestinal disorders||
8310|101|P|(such as ulcers).||
8310|102|P|   Some people taking alendronate may have serious jawbone||
8310|103|P|problems. Your doctor should check your mouth before you start||
8310|104|P|this medication. Tell your dentist that you are taking this||
8310|105|P|medication before you have any dental work done. To help prevent||
8310|106|P|jawbone problems, have regular dental exams and learn how to keep||
8310|107|P|your teeth and gums healthy. If you have jaw pain, tell your||
8310|108|P|doctor and dentist right away.||
8310|109|P|   Before having any surgery (especially dental procedures), tell||
8310|110|P|your doctor and dentist about this medication and all other||
8310|111|P|products you use (including prescription drugs, nonprescription||
8310|112|P|drugs, and herbal products). Your doctor or dentist may tell you||
8310|113|P|to stop taking alendronate before your surgery. Follow all||
8310|114|P|instructions about stopping or starting this medication.||
8310|115|P|   This drug is not recommended for use in children. Studies have||
8310|116|P|shown that many children who took this drug had severe side||
8310|117|P|effects such as vomiting, fever, and flu-like symptoms.||
8310|118|P|   Tell your doctor if you are pregnant or plan to become||
8310|119|P|pregnant. Alendronate may stay in your body for many years. You||
8310|120|P|should not become pregnant while using alendronate. Discuss the||
8310|121|P|risks and benefits with your doctor.||
8310|122|P|   It is unknown if this medication passes into breast milk.||
8310|123|P|Consult your doctor before breastfeeding.||
8310|124|B|||
8310|125|I|DRUG INTERACTIONS:  See also How to Use section.||
8310|126|I|   Drug interactions may change how your medications work or||
8310|127|I|increase your risk for serious side effects. This document does||
8310|128|I|not contain all possible drug interactions. Keep a list of all||
8310|129|I|the products you use (including prescription/nonprescription||
8310|130|I|drugs and herbal products) and share it with your doctor and||
8310|131|I|pharmacist. Do not start, stop, or change the dosage of any||
8310|132|I|medicines without your doctor's approval.||
8310|133|B|||
8310|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8310|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8310|136|O|poison control center right away. US residents can call||
8310|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8310|138|O|Symptoms of overdose may include: severe stomach pain, painful||
8310|139|O|heartburn, pain in the esophagus (chest pain), muscle||
8310|140|O|weakness/cramps, mental/mood changes.||
8310|141|B|||
8310|142|N|NOTES:  Do not share this medication with others.||
8310|143|N|   Lifestyle changes that help promote healthy bones include||
8310|144|N|increasing weight-bearing exercise, stopping smoking, limiting||
8310|145|N|alcohol, and eating well-balanced meals that contain adequate||
8310|146|N|calcium and vitamin D. You may also need to take calcium and||
8310|147|N|vitamin D supplements. Consult your doctor for specific advice.||
8310|148|N|   Lab and/or medical tests (X-rays, height measurement, blood||
8310|149|N|mineral levels) should be done while you are taking this||
8310|150|N|medication. Keep all medical and lab appointments. Consult your||
8310|151|N|doctor for more details.||
8310|152|B|||
8310|153|D|MISSED DOSE:  If you miss a dose, take it the next morning after||
8310|154|D|you remember. Then go back to your weekly dosing schedule on your||
8310|155|D|usual day of the week. Do not take two doses on the same day.||
8310|156|B|||
8310|157|R|STORAGE:  Store at room temperature away from light and moisture.||
8310|158|R|Do not store in the bathroom. Keep all medications away from||
8310|159|R|children and pets.||
8310|160|R|   Do not flush medications down the toilet or pour them into a||
8310|161|R|drain unless instructed to do so. Properly discard this product||
8310|162|R|when it is expired or no longer needed. Consult your pharmacist||
8310|163|R|or local waste disposal company.||
8310|164|B|||
8310|165|A|Information last revised September 2025.||
8310|166|A|Copyright(c) 2025 First Databank, Inc.||
8310|167|B|||
8311|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8311|002|Z|does NOT have all possible information about this product. This||
8311|003|Z|information does not assure that this product is safe, effective,||
8311|004|Z|or appropriate for you. This information is not individual||
8311|005|Z|medical advice and does not substitute for the advice of your||
8311|006|Z|health care professional. Always ask your health care||
8311|007|Z|professional for complete information about this product and your||
8311|008|Z|specific health needs.||
8311|009|B|||
8311|010|T|GINSENG (Eleutherococcus and Panax sp.) - ORAL||
8311|011|B|||
8311|012|U|USES:  Ginseng has been used for improving overall health. It has||
8311|013|U|also been used to strengthen the immune system and help fight off||
8311|014|U|stress and disease. There are different types of ginseng. Asian||
8311|015|U|ginseng (from Chinese and Korean sources) has been used for||
8311|016|U|unclear thinking, diabetes, and male erectile dysfunction.||
8311|017|U|American ginseng has been used for diabetes and for reducing the||
8311|018|U|risk of the common cold and flu. Siberian ginseng has been used||
8311|019|U|for reducing the risk of colds and flu, and for reducing the||
8311|020|U|severity of herpes simplex virus type 2 infections.||
8311|021|U|   Do not give ginseng to infants because it may cause harm. This||
8311|022|U|product is not recommended for use in children.||
8311|023|U|   Some herbal/dietary supplement products have been found to||
8311|024|U|contain possibly harmful impurities/additives. Check with your||
8311|025|U|pharmacist for more details about the brand you use.||
8311|026|U|   The FDA has not reviewed this product for safety or||
8311|027|U|effectiveness. Consult your doctor or pharmacist for more||
8311|028|U|details.||
8311|029|B|||
8311|030|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
8311|031|H|directions on the product package. The dosage is based on the||
8311|032|H|condition the product is used for and the type of ginseng. If you||
8311|033|H|have any questions, ask your doctor or pharmacist.||
8311|034|H|   Since ginseng may cause trouble sleeping, do not take it near||
8311|035|H|bedtime.||
8311|036|H|   Ginseng should not be used for long periods. Asian ginseng||
8311|037|H|should not be used for more than 3 months at a time, and Siberian||
8311|038|H|ginseng should not be used for more than 2 months at a time.||
8311|039|H|American ginseng has been used for up to 1 month, although||
8311|040|H|certain extract products have been used for up to 4 months. Ask||
8311|041|H|your doctor or pharmacist for more details about your product and||
8311|042|H|how to use it safely.||
8311|043|H|   Caffeine can increase the side effects of this product. Avoid||
8311|044|H|drinking large amounts of beverages containing caffeine (coffee,||
8311|045|H|tea, colas), eating large amounts of chocolate, or taking||
8311|046|H|nonprescription products that contain caffeine.||
8311|047|H|   If your condition lasts or gets worse, or if you think you may||
8311|048|H|have a serious medical problem, get medical help right away.||
8311|049|B|||
8311|050|S|SIDE EFFECTS:  Trouble sleeping is the most common side effect.||
8311|051|S|Less common effects include headache, agitation, upset stomach,||
8311|052|S|menstrual problems (such as unusual vaginal bleeding), breast||
8311|053|S|pain, and dizziness. An increase or decrease in blood pressure||
8311|054|S|may also occur. Siberian ginseng may also cause drowsiness,||
8311|055|S|nervousness, or mood changes. If any of these effects last or get||
8311|056|S|worse, tell your doctor or pharmacist promptly.||
8311|057|S|   Tell your doctor right away if you have any serious side||
8311|058|S|effects, including: fast/pounding/irregular heartbeat.||
8311|059|S|   A very serious allergic reaction to this product is rare.||
8311|060|S|However, get medical help right away if you notice any symptoms||
8311|061|S|of a serious allergic reaction, including: rash, itching/swelling||
8311|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8311|063|S|breathing.||
8311|064|S|   This is not a complete list of possible side effects. If you||
8311|065|S|notice other effects not listed above, contact your doctor or||
8311|066|S|pharmacist.||
8311|067|S|   In the US -||
8311|068|S|   Call your doctor for medical advice about side effects. You||
8311|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8311|070|S|www.fda.gov/medwatch.||
8311|071|S|   In Canada - Call your doctor for medical advice about side||
8311|072|S|effects. You may report side effects to Health Canada at||
8311|073|S|1-866-234-2345.||
8311|074|B|||
8311|075|P|PRECAUTIONS:  Before taking ginseng, tell your doctor or||
8311|076|P|pharmacist if you are allergic to it; or to any other ingredients||
8311|077|P|listed on the product label; or if you have any other allergies.||
8311|078|P|This product may contain inactive ingredients, which can cause||
8311|079|P|allergic reactions or other problems. Talk to your pharmacist for||
8311|080|P|more details.||
8311|081|P|   People who are allergic to one type of ginseng should also||
8311|082|P|avoid taking other types.||
8311|083|P|   If you have any of the following health problems, consult your||
8311|084|P|doctor or pharmacist before using this product: high or low blood||
8311|085|P|pressure, heart problems (such as abnormal heart rhythm,||
8311|086|P|rheumatic heart disease), bleeding/clotting problems, a certain||
8311|087|P|mental/mood disorder (schizophrenia), overactive immune system||
8311|088|P|disorders (such as lupus, rheumatoid arthritis, multiple||
8311|089|P|sclerosis), conditions that are affected by estrogen (such as||
8311|090|P|endometriosis, uterine fibroids, cancer of the||
8311|091|P|breast/uterus/ovary).||
8311|092|P|   Ginseng may lower blood sugar levels too much, especially in||
8311|093|P|people with diabetes. Siberian ginseng may lower or raise blood||
8311|094|P|sugar levels. If you have diabetes, monitor your blood sugar more||
8311|095|P|carefully while using this product, and report any unusual||
8311|096|P|results or symptoms to your doctor. Your doctor may need to||
8311|097|P|adjust your diabetes medications.||
8311|098|P|   Liquid forms of this product may contain sugar and/or alcohol.||
8311|099|P|Caution is advised if you have diabetes, alcohol dependence, or||
8311|100|P|liver disease. Ask your doctor or pharmacist about using this||
8311|101|P|product safely.||
8311|102|P|   This product may make you dizzy or drowsy. Alcohol or||
8311|103|P|marijuana (cannabis) can make you more dizzy or drowsy. Do not||
8311|104|P|drive, use machinery, or do anything that needs alertness until||
8311|105|P|you can do it safely. Limit alcoholic beverages. Talk to your||
8311|106|P|doctor if you are using marijuana (cannabis).||
8311|107|P|   This product is not recommended for use during pregnancy.||
8311|108|P|Consult your doctor before using this product.||
8311|109|P|   It is unknown if this product passes into breast milk. Consult||
8311|110|P|your doctor before breastfeeding.||
8311|111|B|||
8311|112|I|DRUG INTERACTIONS:  See also How to Use section.||
8311|113|I|   Drug interactions may change how your medications work or||
8311|114|I|increase your risk for serious side effects. This document does||
8311|115|I|not contain all possible drug interactions. Keep a list of all||
8311|116|I|the products you use (including prescription/nonprescription||
8311|117|I|drugs and herbal products) and share it with your doctor and||
8311|118|I|pharmacist. Do not start, stop, or change the dosage of any||
8311|119|I|medicines without your doctor's approval.||
8311|120|I|   Some drugs that may interact with this product include:||
8311|121|I|fezolinetant, medications/products that may increase your risk of||
8311|122|I|bleeding (including "blood thinners" such as warfarin and||
8311|123|I|heparin, anti-platelet drugs such as clopidogrel, nonsteroidal||
8311|124|I|anti-inflammatory drugs-NSAIDs such as ibuprofen, herbal products||
8311|125|I|such as danshen/garlic/ginger), MAO inhibitors (isocarboxazid,||
8311|126|I|linezolid, metaxalone, methylene blue, moclobemide, phenelzine,||
8311|127|I|procarbazine, rasagiline, safinamide, selegiline,||
8311|128|I|tranylcypromine), drugs that weaken the immune system (including||
8311|129|I|corticosteroids such as prednisone, drugs to prevent organ||
8311|130|I|transplant rejection such as cyclosporine), other herbal products||
8311|131|I|(such as fenugreek, willow bark).||
8311|132|I|   Aspirin may also increase the risk of bleeding when used with||
8311|133|I|this product. If your doctor has prescribed low doses of aspirin||
8311|134|I|to prevent heart attack or stroke (usually 81-162 milligrams a||
8311|135|I|day), you should continue to take the aspirin. Consult your||
8311|136|I|doctor or pharmacist for more details.||
8311|137|I|   Check the labels on all your medicines (such as cough-and-cold||
8311|138|I|products, diet aids) because they may contain ingredients that||
8311|139|I|could increase the side effects of ginseng. Decongestants (such||
8311|140|I|as pseudoephedrine) and stimulants (such as caffeine, ephedra, ma||
8311|141|I|huang) may worsen trouble sleeping, fast heartbeat, and increased||
8311|142|I|blood pressure. Consult your doctor or pharmacist for more||
8311|143|I|details.||
8311|144|I|   If you are taking Siberian ginseng, tell your doctor or||
8311|145|I|pharmacist if you are taking other products that cause drowsiness||
8311|146|I|such as opioid pain or cough relievers (such as codeine,||
8311|147|I|hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or||
8311|148|I|anxiety (such as alprazolam, lorazepam, zolpidem), muscle||
8311|149|I|relaxants (such as carisoprodol, cyclobenzaprine), or||
8311|150|I|antihistamines (such as cetirizine, diphenhydramine).||
8311|151|B|||
8311|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8311|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8311|154|O|poison control center right away. US residents can call||
8311|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8311|156|B|||
8311|157|N|NOTES:  Keep all medical and lab appointments.||
8311|158|N|   Different types and quality of ginseng may have different||
8311|159|N|effects. Read the product label carefully and ask your doctor or||
8311|160|N|pharmacist for more information.||
8311|161|B|||
8311|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8311|163|D|remember. If it is near the time of the next dose, skip the||
8311|164|D|missed dose. Take your next dose at the regular time. Do not||
8311|165|D|double the dose to catch up.||
8311|166|B|||
8311|167|R|STORAGE:  Refer to storage information printed on the package. If||
8311|168|R|you have any questions about storage, ask your pharmacist. Keep||
8311|169|R|all medications and herbal products away from children and pets.||
8311|170|R|   Do not flush medications down the toilet or pour them into a||
8311|171|R|drain unless instructed to do so. Properly discard this product||
8311|172|R|when it is expired or no longer needed. Consult your pharmacist||
8311|173|R|or local waste disposal company.||
8311|174|B|||
8311|175|A|Information last revised October 2025.||
8311|176|A|Copyright(c) 2025 First Databank, Inc.||
8311|177|B|||
8312|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8312|002|Z|does NOT have all possible information about this product. This||
8312|003|Z|information does not assure that this product is safe, effective,||
8312|004|Z|or appropriate for you. This information is not individual||
8312|005|Z|medical advice and does not substitute for the advice of your||
8312|006|Z|health care professional. Always ask your health care||
8312|007|Z|professional for complete information about this product and your||
8312|008|Z|specific health needs.||
8312|009|B|||
8312|010|T|GARLIC (Allium sativum L.) - ORAL||
8312|011|B|||
8312|012|U|USES:  Garlic has been used for blood vessel disease||
8312|013|U|(atherosclerosis) and high blood pressure (hypertension). Consult||
8312|014|U|your doctor for more information if you have heart or blood||
8312|015|U|vessel disease or high blood pressure.||
8312|016|U|   Some herbal/dietary supplement products have been found to||
8312|017|U|contain possibly harmful impurities/additives. Check with your||
8312|018|U|pharmacist for more details about the brand you use.||
8312|019|U|   The FDA has not reviewed this product for safety or||
8312|020|U|effectiveness. Consult your doctor or pharmacist for more||
8312|021|U|details.||
8312|022|B|||
8312|023|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
8312|024|H|directions on the product package. If you have any questions, ask||
8312|025|H|your doctor or pharmacist.||
8312|026|H|   If your condition lasts or gets worse, or if you think you may||
8312|027|H|have a serious medical problem, get medical help right away.||
8312|028|B|||
8312|029|S|SIDE EFFECTS:  Breath and body odor, upset stomach, or heartburn||
8312|030|S|may occur. If any of these effects last or get worse, tell your||
8312|031|S|doctor or pharmacist promptly.||
8312|032|S|   Tell your doctor right away if you have any serious side||
8312|033|S|effects, including: easy or unusual bruising/bleeding.||
8312|034|S|   A very serious allergic reaction to this product is rare.||
8312|035|S|However, get medical help right away if you notice any symptoms||
8312|036|S|of a serious allergic reaction, including: rash, itching/swelling||
8312|037|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8312|038|S|breathing.||
8312|039|S|   This is not a complete list of possible side effects. If you||
8312|040|S|notice other effects not listed above, contact your doctor or||
8312|041|S|pharmacist.||
8312|042|S|   In the US -||
8312|043|S|   Call your doctor for medical advice about side effects. You||
8312|044|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8312|045|S|www.fda.gov/medwatch.||
8312|046|S|   In Canada - Call your doctor for medical advice about side||
8312|047|S|effects. You may report side effects to Health Canada at||
8312|048|S|1-866-234-2345.||
8312|049|B|||
8312|050|P|PRECAUTIONS:  Before taking garlic, tell your doctor or||
8312|051|P|pharmacist if you are allergic to it; or to any other ingredients||
8312|052|P|that may be listed on the product label; or if you have any other||
8312|053|P|allergies. This product may contain inactive ingredients (such as||
8312|054|P|soybean oil), which can cause allergic reactions or other||
8312|055|P|problems. Talk to your pharmacist for more details.||
8312|056|P|   If you have any of the following health problems, consult your||
8312|057|P|doctor or pharmacist before using this product: bleeding/clotting||
8312|058|P|problems, stomach/abdominal problems (such as gut infections,||
8312|059|P|inflammatory bowel disease).||
8312|060|P|   Before having surgery, tell your doctor or dentist about all||
8312|061|P|the products you use (including prescription drugs,||
8312|062|P|nonprescription drugs, and herbal products). Garlic may increase||
8312|063|P|the risk of bleeding problems.||
8312|064|P|   Limit alcohol because it can worsen the risk of stomach upset||
8312|065|P|and bleeding problems.||
8312|066|P|   Liquid forms of this product may contain sugar and/or alcohol.||
8312|067|P|Caution is advised if you have diabetes, alcohol dependence, or||
8312|068|P|liver disease. Ask your doctor or pharmacist about using this||
8312|069|P|product safely.||
8312|070|P|   This product is not recommended for use during pregnancy.||
8312|071|P|Consult your doctor before using this product.||
8312|072|P|   This product may pass into breast milk. Consult your doctor||
8312|073|P|before breastfeeding.||
8312|074|B|||
8312|075|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8312|076|I|medications work or increase your risk for serious side effects.||
8312|077|I|This document does not contain all possible drug interactions.||
8312|078|I|Keep a list of all the products you use (including||
8312|079|I|prescription/nonprescription drugs and herbal products) and share||
8312|080|I|it with your doctor and pharmacist. Do not start, stop, or change||
8312|081|I|the dosage of any medicines without your doctor's approval.||
8312|082|I|   Some drugs that may interact with this product include:||
8312|083|I|non-nucleoside reverse transcriptase inhibitors (NNRTIs such as||
8312|084|I|nevirapine, efavirenz), isoniazid, medications/herbal products||
8312|085|I|that may increase your risk of bleeding (including "blood||
8312|086|I|thinners" such as warfarin and heparin, anti-platelet drugs such||
8312|087|I|as clopidogrel, nonsteroidal anti-inflammatory drugs-NSAIDs such||
8312|088|I|as ibuprofen, herbals such as danshen/ginger/gingko).||
8312|089|I|   This product can speed up or slow down the removal of other||
8312|090|I|medications from your body, which may affect how they work.||
8312|091|I|Examples of affected drugs include acetaminophen, azole||
8312|092|I|antifungals (such as ketoconazole), chlorzoxazone, calcium||
8312|093|I|channel blockers (such as diltiazem), among others.||
8312|094|I|   Aspirin may also increase the risk of bleeding when used with||
8312|095|I|this product. If your doctor has prescribed low doses of aspirin||
8312|096|I|to prevent heart attack or stroke (usually 81-162 milligrams a||
8312|097|I|day), you should continue to take the aspirin. Consult your||
8312|098|I|doctor or pharmacist for more details.||
8312|099|I|   This product may decrease the effectiveness of hormonal birth||
8312|100|I|control such as pills, patch, or ring. This could cause||
8312|101|I|pregnancy. Discuss with your doctor or pharmacist if you should||
8312|102|I|use reliable backup birth control methods while using this||
8312|103|I|product. Also tell your doctor if you have any new spotting or||
8312|104|I|breakthrough bleeding, because these may be signs that your birth||
8312|105|I|control is not working well.||
8312|106|B|||
8312|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8312|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8312|109|O|poison control center right away. US residents can call||
8312|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8312|111|B|||
8312|112|N|NOTES:  Keep all medical and lab appointments.||
8312|113|B|||
8312|114|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8312|115|D|remember. If it is near the time of the next dose, skip the||
8312|116|D|missed dose. Take your next dose at the regular time. Do not||
8312|117|D|double the dose to catch up.||
8312|118|B|||
8312|119|R|STORAGE:  Refer to storage information printed on the package. If||
8312|120|R|you have any questions about storage, ask your pharmacist. Keep||
8312|121|R|all medications and herbal products away from children and pets.||
8312|122|R|   Do not flush medications down the toilet or pour them into a||
8312|123|R|drain unless instructed to do so. Properly discard this product||
8312|124|R|when it is expired or no longer needed. Consult your pharmacist||
8312|125|R|or local waste disposal company.||
8312|126|B|||
8312|127|A|Information last revised April 2025.||
8312|128|A|Copyright(c) 2025 First Databank, Inc.||
8312|129|B|||
8313|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8313|002|Z|does NOT have all possible information about this product. This||
8313|003|Z|information does not assure that this product is safe, effective,||
8313|004|Z|or appropriate for you. This information is not individual||
8313|005|Z|medical advice and does not substitute for the advice of your||
8313|006|Z|health care professional. Always ask your health care||
8313|007|Z|professional for complete information about this product and your||
8313|008|Z|specific health needs.||
8313|009|B|||
8313|010|T|GINKGO (Ginkgo biloba) - ORAL||
8313|011|B|||
8313|012|U|USES:  Ginkgo has been used for improving blood flow, for||
8313|013|U|improving memory/concentration due to certain brain problems||
8313|014|U|(such as Alzheimer's disease, dementia), and for relief of||
8313|015|U|premenstrual syndrome (PMS), eye problems, and dizziness.||
8313|016|U|   Look for ginkgo products that contain standardized gingko leaf||
8313|017|U|extracts. Avoid using products that contain fresh or roasted||
8313|018|U|gingko seeds. The seeds may contain a toxic chemical. Seizures||
8313|019|U|and death have occurred in people who ate as few as 10 seeds. The||
8313|020|U|risk is higher in children.||
8313|021|U|   Some herbal/diet supplement products have been found to||
8313|022|U|contain possibly harmful impurities/additives. Check with your||
8313|023|U|pharmacist for more details about the brand you use.||
8313|024|U|   The FDA has not reviewed this product for safety or||
8313|025|U|effectiveness. Consult your doctor or pharmacist for more||
8313|026|U|details.||
8313|027|B|||
8313|028|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
8313|029|H|directions on the product package. If you have any questions, ask||
8313|030|H|your doctor or pharmacist.||
8313|031|H|   Consult your doctor or pharmacist before using this product||
8313|032|H|for memory loss or brain problems. Your condition may require||
8313|033|H|medical attention.||
8313|034|H|   This herbal product should not be used for more than 3 months||
8313|035|H|at a time. Consult your doctor or pharmacist.||
8313|036|H|   If your condition lasts or gets worse, or if you think you may||
8313|037|H|have a serious medical problem, get medical help right away.||
8313|038|B|||
8313|039|S|SIDE EFFECTS:  Stomach upset, nausea, diarrhea, dizziness, or||
8313|040|S|headache may occur. If any of these effects last or get worse,||
8313|041|S|tell your doctor or pharmacist promptly.||
8313|042|S|   Get medical help right away if you have any very serious side||
8313|043|S|effects, including: easy bleeding/bruising, fainting, irregular||
8313|044|S|heartbeat, inability to move (paralysis), muscle weakness,||
8313|045|S|restlessness, seizures, trouble speaking, severe headache,||
8313|046|S|weakness on one side of the body, vision problems.||
8313|047|S|   A very serious allergic reaction to this product is rare.||
8313|048|S|However, get medical help right away if you notice any symptoms||
8313|049|S|of a serious allergic reaction, including: rash, itching/swelling||
8313|050|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8313|051|S|breathing.||
8313|052|S|   This is not a complete list of possible side effects. If you||
8313|053|S|notice other effects not listed above, contact your doctor or||
8313|054|S|pharmacist.||
8313|055|S|   In the US -||
8313|056|S|   Call your doctor for medical advice about side effects. You||
8313|057|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8313|058|S|www.fda.gov/medwatch.||
8313|059|S|   In Canada - Call your doctor for medical advice about side||
8313|060|S|effects. You may report side effects to Health Canada at||
8313|061|S|1-866-234-2345.||
8313|062|B|||
8313|063|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
8313|064|P|pharmacist if you are allergic to it; or if you have any other||
8313|065|P|allergies. This product may contain inactive ingredients, which||
8313|066|P|can cause allergic reactions or other problems. Talk to your||
8313|067|P|pharmacist for more details.||
8313|068|P|   If you have any of the following health problems, consult your||
8313|069|P|doctor or pharmacist before using this product: bleeding||
8313|070|P|problems, diabetes, seizures.||
8313|071|P|   Before having surgery, tell your doctor or dentist about all||
8313|072|P|the products you use (including prescription drugs,||
8313|073|P|nonprescription drugs, and herbal products). Ginkgo may decrease||
8313|074|P|the ability of blood to clot. Stop taking this product at least 2||
8313|075|P|weeks before your surgery unless otherwise directed by your||
8313|076|P|doctor. Ask your doctor when it is safe to start using this||
8313|077|P|product after your surgery or procedure.||
8313|078|P|   Liquid forms of this product may contain sugar and/or alcohol.||
8313|079|P|Caution is advised if you have diabetes, alcohol dependence, or||
8313|080|P|liver disease. Ask your doctor or pharmacist about using this||
8313|081|P|product safely.||
8313|082|P|   Ginkgo is not recommended for use during pregnancy. Consult||
8313|083|P|your doctor before using this product.||
8313|084|P|   It is unknown if this product passes into breast milk. Consult||
8313|085|P|your doctor before breastfeeding.||
8313|086|B|||
8313|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8313|088|I|medications work or increase your risk for serious side effects.||
8313|089|I|This document does not contain all possible drug interactions.||
8313|090|I|Keep a list of all the products you use (including||
8313|091|I|prescription/nonprescription drugs and herbal products) and share||
8313|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
8313|093|I|the dosage of any medicines without your doctor's approval.||
8313|094|I|   Some drugs that may interact with this product are:||
8313|095|I|anti-seizure medications (such as gabapentin, phenytoin),||
8313|096|I|nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen,||
8313|097|I|naproxen, piroxicam), omeprazole, trazodone, medications/herbal||
8313|098|I|products that may increase your risk of bleeding (including||
8313|099|I|"blood thinners" such as warfarin and heparin, anti-platelet||
8313|100|I|drugs such as clopidogrel, herbs such as danshen/garlic/ginger).||
8313|101|I|   Aspirin may also increase the risk of bleeding when used with||
8313|102|I|this product. If your doctor has prescribed low doses of aspirin||
8313|103|I|to prevent heart attack or stroke (usually 81-162 milligrams a||
8313|104|I|day), you should continue to take the aspirin. Consult your||
8313|105|I|doctor or pharmacist for more details.||
8313|106|B|||
8313|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8313|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8313|109|O|poison control center right away. US residents can call||
8313|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8313|111|O|Symptoms of overdose may include: difficulty breathing, seizures,||
8313|112|O|loss of consciousness.||
8313|113|B|||
8313|114|N|NOTES:  Keep all medical and lab test appointments.||
8313|115|B|||
8313|116|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8313|117|D|If it is near the time of the next dose, skip the missed dose.||
8313|118|D|Use your next dose at the regular time. Do not double the dose to||
8313|119|D|catch up.||
8313|120|B|||
8313|121|R|STORAGE:  Refer to storage information printed on the package. If||
8313|122|R|you have any questions about storage, ask your pharmacist. Keep||
8313|123|R|all medications and herbal products away from children and pets.||
8313|124|R|   Do not flush medications down the toilet or pour them into a||
8313|125|R|drain unless instructed to do so. Properly discard this product||
8313|126|R|when it is expired or no longer needed. Consult your pharmacist||
8313|127|R|or local waste disposal company.||
8313|128|B|||
8313|129|A|Information last revised April 2025.||
8313|130|A|Copyright(c) 2025 First Databank, Inc.||
8313|131|B|||
8314|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8314|002|Z|does NOT have all possible information about this product. This||
8314|003|Z|information does not assure that this product is safe, effective,||
8314|004|Z|or appropriate for you. This information is not individual||
8314|005|Z|medical advice and does not substitute for the advice of your||
8314|006|Z|health care professional. Always ask your health care||
8314|007|Z|professional for complete information about this product and your||
8314|008|Z|specific health needs.||
8314|009|B|||
8314|010|T|RED YEAST RICE (MONASCUS PURPUREUS) - ORAL||
8314|011|B|||
8314|012|U|USES:  Red yeast rice has been used for lowering cholesterol||
8314|013|U|levels.||
8314|014|U|   Some supplement products have been found to contain possibly||
8314|015|U|harmful impurities/additives. Check with your pharmacist for more||
8314|016|U|details regarding the particular brand you use.||
8314|017|U|   The FDA has not reviewed this product for safety or||
8314|018|U|effectiveness. Ask your doctor or pharmacist for more details.||
8314|019|B|||
8314|020|H|HOW TO USE:  Take this product by mouth with food. Follow all||
8314|021|H|directions on the product package, or if your doctor prescribed||
8314|022|H|this product, take as directed by your doctor. If you have any||
8314|023|H|questions, ask your doctor or pharmacist.||
8314|024|H|   Avoid eating grapefruit or drinking grapefruit juice while||
8314|025|H|using this product unless your doctor or pharmacist says you may||
8314|026|H|do so safely. Grapefruit can increase the chance of side effects||
8314|027|H|with this product. Ask your doctor or pharmacist for more||
8314|028|H|details.||
8314|029|H|   If your condition lasts or gets worse, or if you think you may||
8314|030|H|have a serious medical problem, get medical help right away.||
8314|031|B|||
8314|032|S|SIDE EFFECTS:  Abdominal/stomach pain may occur. If any of these||
8314|033|S|effects last or get worse, tell your doctor or pharmacist||
8314|034|S|promptly.||
8314|035|S|   Tell your doctor right away if you have any serious side||
8314|036|S|effects, including: muscle pain/tenderness/weakness (especially||
8314|037|S|with fever or unusual tiredness), signs of kidney problems (such||
8314|038|S|as change in the amount of urine), signs of liver problems (such||
8314|039|S|as nausea/vomiting that doesn't stop, severe stomach/abdominal||
8314|040|S|pain, yellowing eyes/skin, dark urine).||
8314|041|S|   A very serious allergic reaction to this product is rare.||
8314|042|S|However, get medical help right away if you notice any symptoms||
8314|043|S|of a serious allergic reaction, including: rash, itching/swelling||
8314|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8314|045|S|breathing.||
8314|046|S|   This is not a complete list of possible side effects. If you||
8314|047|S|notice other effects not listed above, contact your doctor or||
8314|048|S|pharmacist.||
8314|049|S|   In the US -||
8314|050|S|   Call your doctor for medical advice about side effects. You||
8314|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8314|052|S|www.fda.gov/medwatch.||
8314|053|S|   In Canada - Call your doctor for medical advice about side||
8314|054|S|effects. You may report side effects to Health Canada at||
8314|055|S|1-866-234-2345.||
8314|056|B|||
8314|057|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
8314|058|P|pharmacist if you are allergic to it; or if you have any other||
8314|059|P|allergies. This product may contain inactive ingredients, which||
8314|060|P|can cause allergic reactions or other problems. Talk to your||
8314|061|P|pharmacist for more details.||
8314|062|P|   If you have any of the following health problems, consult your||
8314|063|P|doctor or pharmacist before using this product: liver disease,||
8314|064|P|kidney disease, alcohol use.||
8314|065|P|   Before having surgery, tell your doctor or dentist about all||
8314|066|P|the products you use (including prescription drugs,||
8314|067|P|nonprescription drugs, and herbal products).||
8314|068|P|   Limit alcoholic beverages. Daily use of alcohol may increase||
8314|069|P|your risk for liver problems, especially when combined with this||
8314|070|P|product. Ask your doctor or pharmacist for more information.||
8314|071|P|   Red yeast rice must not be used during pregnancy. It may harm||
8314|072|P|an unborn baby. If you become pregnant or think you may be||
8314|073|P|pregnant, tell your doctor right away.||
8314|074|P|   It is unknown if this product passes into breast milk. Because||
8314|075|P|of the possible risk to the infant, breastfeeding is not||
8314|076|P|recommended while using this product. Consult your doctor before||
8314|077|P|breastfeeding.||
8314|078|B|||
8314|079|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8314|080|I|medications work or increase your risk for serious side effects.||
8314|081|I|This document does not contain all possible drug interactions.||
8314|082|I|Keep a list of all the products you use (including||
8314|083|I|prescription/nonprescription drugs and herbal products) and share||
8314|084|I|it with your doctor and pharmacist. Do not start, stop, or change||
8314|085|I|the dosage of any medicines without your doctor's approval.||
8314|086|I|   Some drugs that may interact with this product include: azole||
8314|087|I|antifungals (such as itraconazole, ketoconazole), "blood||
8314|088|I|thinners" (such as warfarin), macrolide antibiotics (such as||
8314|089|I|erythromycin, clarithromycin), nefazodone, ritonavir,||
8314|090|I|telithromycin.||
8314|091|I|   Some red yeast rice products may also contain a "statin"||
8314|092|I|cholesterol-lowering drug called lovastatin. Taking too much of a||
8314|093|I|statin can increase your risk of serious side effects (such as||
8314|094|I|muscle and liver problems). Since you may not know if your||
8314|095|I|product contains lovastatin, do not take any red yeast rice||
8314|096|I|products if you are also taking any statin drugs (such as||
8314|097|I|atorvastatin, lovastatin, simvastatin).||
8314|098|B|||
8314|099|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8314|100|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8314|101|O|poison control center right away. US residents can call||
8314|102|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8314|103|B|||
8314|104|N|NOTES:  Keep all medical and lab appointments.||
8314|105|N|   A low-cholesterol/low-fat diet and exercise are important||
8314|106|N|parts of controlling cholesterol levels and decreasing your risk||
8314|107|N|of heart disease. Consult your doctor for more details.||
8314|108|B|||
8314|109|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8314|110|D|remember. If it is near the time of the next dose, skip the||
8314|111|D|missed dose. Take your next dose at the regular time. Do not||
8314|112|D|double the dose to catch up.||
8314|113|B|||
8314|114|R|STORAGE:  Refer to storage information printed on the package. If||
8314|115|R|you have any questions about storage, ask your pharmacist. Keep||
8314|116|R|all medications and herbal products away from children and pets.||
8314|117|R|   Do not flush medications down the toilet or pour them into a||
8314|118|R|drain unless instructed to do so. Properly discard this product||
8314|119|R|when it is expired or no longer needed. Consult your pharmacist||
8314|120|R|or local waste disposal company.||
8314|121|B|||
8314|122|A|Information last revised May 2024.||
8314|123|A|Copyright(c) 2025 First Databank, Inc.||
8314|124|B|||
8316|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8316|002|Z|does NOT have all possible information about this product. This||
8316|003|Z|information does not assure that this product is safe, effective,||
8316|004|Z|or appropriate for you. This information is not individual||
8316|005|Z|medical advice and does not substitute for the advice of your||
8316|006|Z|health care professional. Always ask your health care||
8316|007|Z|professional for complete information about this product and your||
8316|008|Z|specific health needs.||
8316|009|B|||
8316|010|T|GRAPE SEED (Vitis vinifera, Vitis coignetiae) - ORAL||
8316|011|B|||
8316|012|U|USES:  Grape seed has been used for blood circulation problems||
8316|013|U|(venous insufficiency, edema) and certain eye problems (eye||
8316|014|U|strain). Grape seed has also been used as a source of||
8316|015|U|antioxidants and essential fatty acids to protect against heart||
8316|016|U|disease.||
8316|017|U|   Some herbal/diet supplement products have been found to||
8316|018|U|contain possibly harmful impurities/additives. Check with your||
8316|019|U|pharmacist for more details about the particular brand you use.||
8316|020|U|   The FDA has not reviewed this product for safety or||
8316|021|U|effectiveness. Consult your doctor or pharmacist for more||
8316|022|U|details.||
8316|023|B|||
8316|024|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
8316|025|H|directions on the product package. If you have any questions, ask||
8316|026|H|your doctor or pharmacist.||
8316|027|H|   Do not crush or chew extended-release tablets. Doing so can||
8316|028|H|release all of the drug at once, increasing the risk of side||
8316|029|H|effects. Swallow the whole tablet without crushing or chewing.||
8316|030|H|   This product may prevent the growth of Lactobacillus||
8316|031|H|acidophilus, a type of bacteria normally present in the gut that||
8316|032|H|is sometimes taken to maintain gut health. Do not take grape seed||
8316|033|H|at the same time as Lactobacillus products (such as live-culture||
8316|034|H|yogurt). Take these products 2 or more hours apart.||
8316|035|H|   If your condition lasts or gets worse, or if you think you may||
8316|036|H|have a serious medical problem, get medical help right away.||
8316|037|B|||
8316|038|S|SIDE EFFECTS:  Headache, abdominal pain, sore throat, nausea, and||
8316|039|S|diarrhea may occur. If any of these effects last or get worse,||
8316|040|S|tell your doctor or pharmacist promptly.||
8316|041|S|   A very serious allergic reaction to this product is rare.||
8316|042|S|However, get medical help right away if you notice any symptoms||
8316|043|S|of a serious allergic reaction, including: rash, itching/swelling||
8316|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8316|045|S|breathing.||
8316|046|S|   This is not a complete list of possible side effects. If you||
8316|047|S|notice other effects not listed above, contact your doctor or||
8316|048|S|pharmacist.||
8316|049|S|   In the US -||
8316|050|S|   Call your doctor for medical advice about side effects. You||
8316|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8316|052|S|www.fda.gov/medwatch.||
8316|053|S|   In Canada - Call your doctor for medical advice about side||
8316|054|S|effects. You may report side effects to Health Canada at||
8316|055|S|1-866-234-2345.||
8316|056|B|||
8316|057|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
8316|058|P|pharmacist if you are allergic to it; or if you have any other||
8316|059|P|allergies. This product may contain inactive ingredients, which||
8316|060|P|can cause allergic reactions or other problems. Talk to your||
8316|061|P|pharmacist for more details.||
8316|062|P|   If you have any health problems, consult your doctor or||
8316|063|P|pharmacist before using this product.||
8316|064|P|   Liquid forms of this product may contain sugar and/or alcohol.||
8316|065|P|Caution is advised if you have diabetes, alcohol dependence, or||
8316|066|P|liver disease. Ask your doctor or pharmacist about using this||
8316|067|P|product safely.||
8316|068|P|   During pregnancy, this product should be used only when||
8316|069|P|clearly needed. Discuss the risks and benefits with your doctor.||
8316|070|P|   It is unknown if this product passes into breast milk. Consult||
8316|071|P|your doctor before breastfeeding.||
8316|072|B|||
8316|073|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8316|074|I|medications work or increase your risk for serious side effects.||
8316|075|I|This document does not contain all possible drug interactions.||
8316|076|I|Keep a list of all the products you use (including||
8316|077|I|prescription/nonprescription drugs and herbal products) and share||
8316|078|I|it with your doctor and pharmacist. Do not start, stop, or change||
8316|079|I|the dosage of any medicines without your doctor's approval.||
8316|080|I|   A drug that may interact with this product is: phenacetin.||
8316|081|B|||
8316|082|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8316|083|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8316|084|O|poison control center right away. US residents can call||
8316|085|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8316|086|B|||
8316|087|N|NOTES:  Keep all medical and lab test appointments.||
8316|088|B|||
8316|089|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8316|090|D|If it is near the time of the next dose, skip the missed dose.||
8316|091|D|Use your next dose at the regular time. Do not double the dose to||
8316|092|D|catch up.||
8316|093|B|||
8316|094|R|STORAGE:  Refer to storage information printed on the package. If||
8316|095|R|you have any questions about storage, ask your pharmacist. Keep||
8316|096|R|all medications and herbal products away from children and pets.||
8316|097|R|   Do not flush medications down the toilet or pour them into a||
8316|098|R|drain unless instructed to do so. Properly discard this product||
8316|099|R|when it is expired or no longer needed. Consult your pharmacist||
8316|100|R|or local waste disposal company.||
8316|101|B|||
8316|102|A|Information last revised May 2024.||
8316|103|A|Copyright(c) 2025 First Databank, Inc.||
8316|104|B|||
8317|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8317|002|Z|does NOT have all possible information about this product. This||
8317|003|Z|information does not assure that this product is safe, effective,||
8317|004|Z|or appropriate for you. This information is not individual||
8317|005|Z|medical advice and does not substitute for the advice of your||
8317|006|Z|health care professional. Always ask your health care||
8317|007|Z|professional for complete information about this product and your||
8317|008|Z|specific health needs.||
8317|009|B|||
8317|010|T|LEVOFLOXACIN - INJECTION||
8317|011|F|(LEE-voe-FLOX-a-sin)||
8317|012|B|||
8317|013|C|COMMON BRAND NAME(S): Levaquin||
8317|014|B|||
8317|015|W|WARNING:  Quinolone antibiotics (including levofloxacin) may||
8317|016|W|cause serious and possibly permanent tendon damage (such as||
8317|017|W|tendonitis, tendon rupture), nerve problems in the arms and legs||
8317|018|W|(peripheral neuropathy), and nervous system problems. Get medical||
8317|019|W|help right away if you have any of the following symptoms:||
8317|020|W|pain/numbness/burning/tingling/weakness in your||
8317|021|W|arms/hands/legs/feet, changes in how you sense||
8317|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
8317|023|W|headache, vision changes, shaking (tremors), seizures,||
8317|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
8317|025|W|hallucinations, depression, rare thoughts of suicide).||
8317|026|W|   Tendon damage may occur during or after treatment with this||
8317|027|W|medication. Stop exercising, rest, and get medical help right||
8317|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
8317|029|W|risk for tendon problems is greater if you are over 60 years of||
8317|030|W|age, if you are taking corticosteroids (such as prednisone), or||
8317|031|W|if you have a kidney, heart, or lung transplant.||
8317|032|W|   This medication may make a certain muscle condition||
8317|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
8317|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
8317|035|W|unsteady walk) or trouble breathing.||
8317|036|W|   Discuss the risks and benefits with your doctor before using||
8317|037|W|this medication.||
8317|038|B|||
8317|039|U|USES:  This medication is used to treat a variety of bacterial||
8317|040|U|infections. Levofloxacin belongs to a class of drugs known as||
8317|041|U|quinolone antibiotics. It works by stopping the growth of||
8317|042|U|bacteria. Levofloxacin injection is used if you cannot take the||
8317|043|U|medication by mouth.||
8317|044|B|||
8317|045|H|HOW TO USE:  Read the Medication Guide provided by your||
8317|046|H|pharmacist before you start using levofloxacin and each time you||
8317|047|H|get a refill. If you have any questions, ask your doctor or||
8317|048|H|pharmacist.||
8317|049|H|   If you are using this medication at home, learn all||
8317|050|H|preparation and usage instructions from your health care||
8317|051|H|professional. Before using, check this product for particles or||
8317|052|H|discoloration. If either is present, do not use the liquid. Learn||
8317|053|H|how to store and discard medical supplies safely.||
8317|054|H|   This medication is given by injection into a vein as directed||
8317|055|H|by your doctor, usually once a day over at least 1 hour. The||
8317|056|H|dosage and length of treatment depend on your condition and||
8317|057|H|response to treatment. Children's dosage is also based on weight.||
8317|058|H|   Drink plenty of fluids while using this medication unless||
8317|059|H|otherwise directed by your doctor.||
8317|060|H|   For the best effect, use this antibiotic at evenly spaced||
8317|061|H|times. To help you remember, use this medication at the same time||
8317|062|H|every day.||
8317|063|H|   Continue to use this medication until the full prescribed||
8317|064|H|amount is finished, even if symptoms disappear after a few days.||
8317|065|H|Stopping the medication too early may result in a return of the||
8317|066|H|infection.||
8317|067|H|   Tell your doctor if your condition lasts or gets worse.||
8317|068|B|||
8317|069|S|SIDE EFFECTS:  See also Warning section.||
8317|070|S|   Pain/redness/swelling at the injection site, nausea, diarrhea,||
8317|071|S|headache, dizziness, lightheadedness, or trouble sleeping may||
8317|072|S|occur. If any of these effects last or get worse, tell your||
8317|073|S|doctor or pharmacist promptly.||
8317|074|S|   Remember that this medication has been prescribed because your||
8317|075|S|doctor has judged that the benefit to you is greater than the||
8317|076|S|risk of side effects. Many people using this medication do not||
8317|077|S|have serious side effects.||
8317|078|S|   Tell your doctor right away if you have any serious side||
8317|079|S|effects, including: unusual bruising/bleeding, signs of kidney||
8317|080|S|problems (such as change in the amount of urine), signs of liver||
8317|081|S|problems (such as nausea/vomiting that doesn't stop, loss of||
8317|082|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
8317|083|S|urine).||
8317|084|S|   Get medical help right away if you have any very serious side||
8317|085|S|effects, including: chest pain, severe dizziness, fainting,||
8317|086|S|fast/irregular heartbeat, signs of a tear/break in the main blood||
8317|087|S|vessel called the aorta (such as sudden/severe pain in the||
8317|088|S|stomach/chest/back, shortness of breath).||
8317|089|S|   This medication may rarely cause a severe intestinal condition||
8317|090|S|due to a bacteria called C. difficile. This condition may occur||
8317|091|S|during treatment or weeks to months after treatment has stopped.||
8317|092|S|Tell your doctor right away if you develop: diarrhea that doesn't||
8317|093|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
8317|094|S|stool.||
8317|095|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
8317|096|S|products because they may make symptoms worse.||
8317|097|S|   Use of this medication for prolonged or repeated periods may||
8317|098|S|result in oral thrush or a new yeast infection. Contact your||
8317|099|S|doctor if you notice white patches in your mouth, a change in||
8317|100|S|vaginal discharge, or other new symptoms.||
8317|101|S|   A very serious allergic reaction to this drug is rare.||
8317|102|S|However, get medical help right away if you notice any symptoms||
8317|103|S|of a serious allergic reaction, including: rash, itching/swelling||
8317|104|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8317|105|S|breathing.||
8317|106|S|   This is not a complete list of possible side effects. If you||
8317|107|S|notice other effects not listed above, contact your doctor or||
8317|108|S|pharmacist.||
8317|109|S|   In the US -||
8317|110|S|   Call your doctor for medical advice about side effects. You||
8317|111|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8317|112|S|www.fda.gov/medwatch.||
8317|113|S|   In Canada - Call your doctor for medical advice about side||
8317|114|S|effects. You may report side effects to Health Canada at||
8317|115|S|1-866-234-2345.||
8317|116|B|||
8317|117|P|PRECAUTIONS:  Before using levofloxacin, tell your doctor or||
8317|118|P|pharmacist if you are allergic to it; or to other quinolone||
8317|119|P|antibiotics (such as ciprofloxacin, moxifloxacin, ofloxacin); or||
8317|120|P|if you have any other allergies. This product may contain||
8317|121|P|inactive ingredients, which can cause allergic reactions or other||
8317|122|P|problems. Talk to your pharmacist for more details.||
8317|123|P|   Before using this medication, tell your doctor or pharmacist||
8317|124|P|your medical history, especially of: diabetes, joint/tendon||
8317|125|P|problems (such as tendonitis, bursitis), kidney disease,||
8317|126|P|mental/mood disorders (such as depression), a certain muscle||
8317|127|P|condition (myasthenia gravis), nerve problems (such as peripheral||
8317|128|P|neuropathy), seizure disorder, blood vessel problems (such as||
8317|129|P|aneurysm or blockage of the aorta or other blood vessels,||
8317|130|P|hardening of the arteries), high blood pressure, certain genetic||
8317|131|P|conditions (Marfan syndrome, Ehlers-Danlos syndrome).||
8317|132|P|   Levofloxacin may cause a condition that affects the heart||
8317|133|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8317|134|P|serious (rarely fatal) fast/irregular heartbeat and other||
8317|135|P|symptoms (such as severe dizziness, fainting) that need medical||
8317|136|P|attention right away.||
8317|137|P|   The risk of QT prolongation may be increased if you have||
8317|138|P|certain medical conditions or are taking other drugs that may||
8317|139|P|cause QT prolongation. Before using levofloxacin, tell your||
8317|140|P|doctor or pharmacist of all the drugs you take and if you have||
8317|141|P|any of the following conditions: certain heart problems (heart||
8317|142|P|failure, slow heartbeat, QT prolongation in the EKG), family||
8317|143|P|history of certain heart problems (QT prolongation in the EKG,||
8317|144|P|sudden cardiac death).||
8317|145|P|   Low levels of potassium or magnesium in the blood may also||
8317|146|P|increase your risk of QT prolongation. This risk may increase if||
8317|147|P|you use certain drugs (such as diuretics/"water pills") or if you||
8317|148|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8317|149|P|Talk to your doctor about using levofloxacin safely.||
8317|150|P|   This medication may rarely cause serious changes in blood||
8317|151|P|sugar, especially if you have diabetes. Check your blood sugar||
8317|152|P|regularly as directed and share the results with your doctor.||
8317|153|P|Watch for symptoms of high blood sugar, such as increased||
8317|154|P|thirst/urination. Also watch for symptoms of low blood sugar such||
8317|155|P|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
8317|156|P|vision, dizziness, or tingling hands/feet. It is a good habit to||
8317|157|P|carry glucose tablets or gel to treat low blood sugar. If you||
8317|158|P|don't have these reliable forms of glucose, rapidly raise your||
8317|159|P|blood sugar by eating a quick source of sugar such as table||
8317|160|P|sugar, honey, or candy, or by drinking fruit juice or non-diet||
8317|161|P|soda. Tell your doctor right away about the reaction and the use||
8317|162|P|of this product. To help prevent low blood sugar, eat meals on a||
8317|163|P|regular schedule, and do not skip meals. Your doctor may need to||
8317|164|P|switch you to another antibiotic or adjust your diabetes||
8317|165|P|medications if any reaction occurs.||
8317|166|P|   This drug may make you dizzy or lightheaded. Alcohol or||
8317|167|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
8317|168|P|machinery, or do anything that needs alertness until you can do||
8317|169|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8317|170|P|are using marijuana (cannabis).||
8317|171|P|   This medication may make you more sensitive to the sun. Limit||
8317|172|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8317|173|P|sunscreen and wear protective clothing when outdoors. Tell your||
8317|174|P|doctor right away if you get sunburned or have skin||
8317|175|P|blisters/redness.||
8317|176|P|   Levofloxacin may cause live bacterial vaccines (such as||
8317|177|P|typhoid vaccine) to not work well. Tell your health care||
8317|178|P|professional that you are using levofloxacin before having any||
8317|179|P|immunizations/vaccinations.||
8317|180|P|   Before having surgery, tell your doctor or dentist about all||
8317|181|P|the products you use (including prescription drugs,||
8317|182|P|nonprescription drugs, and herbal products).||
8317|183|P|   Children may be at greater risk for joint/tendon problems||
8317|184|P|while using this drug. Discuss the risks and benefits with the||
8317|185|P|doctor.||
8317|186|P|   Older adults may be at greater risk for tendon problems||
8317|187|P|(especially if they are also taking corticosteroids such as||
8317|188|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
8317|189|P|tear/break in the main blood vessel (aorta).||
8317|190|P|   During pregnancy, this medication should be used only when||
8317|191|P|clearly needed. Discuss the risks and benefits with your doctor.||
8317|192|P|   This drug passes into breast milk. Consult your doctor before||
8317|193|P|breastfeeding.||
8317|194|B|||
8317|195|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8317|196|I|medications work or increase your risk for serious side effects.||
8317|197|I|This document does not contain all possible drug interactions.||
8317|198|I|Keep a list of all the products you use (including||
8317|199|I|prescription/nonprescription drugs and herbal products) and share||
8317|200|I|it with your doctor and pharmacist. Do not start, stop, or change||
8317|201|I|the dosage of any medicines without your doctor's approval.||
8317|202|I|   Levofloxacin is very similar to ofloxacin. Do not use||
8317|203|I|medications containing ofloxacin while using levofloxacin.||
8317|204|I|   This medication may interfere with certain lab tests (such as||
8317|205|I|urine screening for opiates), possibly causing false test||
8317|206|I|results. Make sure lab personnel and all your doctors know you||
8317|207|I|use this drug.||
8317|208|B|||
8317|209|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8317|210|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8317|211|O|poison control center right away. US residents can call||
8317|212|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8317|213|O|Symptoms of overdose may include: severe dizziness.||
8317|214|B|||
8317|215|N|NOTES:  Lab tests (such as kidney function, complete blood count,||
8317|216|N|blood sugar, cultures) may be done before you start using this||
8317|217|N|medication and while you are using it. Keep all medical and lab||
8317|218|N|appointments.||
8317|219|B|||
8317|220|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
8317|221|D|right away for a new dosing schedule. Do not double the dose to||
8317|222|D|catch up.||
8317|223|B|||
8317|224|R|STORAGE:  Different brands of this medication have different||
8317|225|R|storage needs. Check the product package for instructions on how||
8317|226|R|to store your brand, or ask your pharmacist. Keep all medications||
8317|227|R|away from children and pets.||
8317|228|R|   Do not flush medications down the toilet or pour them into a||
8317|229|R|drain unless instructed to do so. Properly discard this product||
8317|230|R|when it is expired or no longer needed. Consult your pharmacist||
8317|231|R|or local waste disposal company.||
8317|232|B|||
8317|233|A|Information last revised December 2024.||
8317|234|A|Copyright(c) 2025 First Databank, Inc.||
8317|235|B|||
8326|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8326|002|Z|does NOT have all possible information about this product. This||
8326|003|Z|information does not assure that this product is safe, effective,||
8326|004|Z|or appropriate for you. This information is not individual||
8326|005|Z|medical advice and does not substitute for the advice of your||
8326|006|Z|health care professional. Always ask your health care||
8326|007|Z|professional for complete information about this product and your||
8326|008|Z|specific health needs.||
8326|009|B|||
8326|010|T|CASPOFUNGIN - INJECTION||
8326|011|F|(KAS-poe-FUN-jin)||
8326|012|B|||
8326|013|C|COMMON BRAND NAME(S): Cancidas||
8326|014|B|||
8326|015|U|USES:  Caspofungin is used to treat a variety of fungal||
8326|016|U|infections. Caspofungin belongs to a class of drugs known as||
8326|017|U|echinocandins. It works by stopping the growth of fungi.||
8326|018|B|||
8326|019|H|HOW TO USE:  This medication is given by injection into a vein as||
8326|020|H|directed by your doctor, usually once a day over 1 hour. The||
8326|021|H|dosage and length of treatment are based on your medical||
8326|022|H|condition, response to treatment, and other medications you may||
8326|023|H|be taking. Children's dosage is also based on body size. Be sure||
8326|024|H|to tell your doctor and pharmacist about all the products you use||
8326|025|H|(including prescription drugs, nonprescription drugs, and herbal||
8326|026|H|products).||
8326|027|H|   If you are using this medication at home, learn all||
8326|028|H|preparation and usage instructions from your health care||
8326|029|H|professional. Before using, check this product for particles or||
8326|030|H|discoloration. If either is present, do not use the liquid.||
8326|031|H|   Learn how to store and discard medical supplies safely.||
8326|032|H|   Infusion reactions may happen during the infusion of this||
8326|033|H|drug. Tell your doctor right away if you have any symptoms of||
8326|034|H|infusion reactions such as fever, chills, shortness of breath,||
8326|035|H|flushing, or dizziness.||
8326|036|H|   Continue to use this medication until the full prescribed||
8326|037|H|amount is finished, even if symptoms disappear after a few days.||
8326|038|H|Stopping the medication too early may result in a return of the||
8326|039|H|infection.||
8326|040|H|   Tell your doctor if your condition does not get better or if||
8326|041|H|it gets worse.||
8326|042|B|||
8326|043|S|SIDE EFFECTS:  See also How to Use section.||
8326|044|S|   Swelling/redness/irritation at the injection site,||
8326|045|S|nausea/vomiting, diarrhea, or headache may occur. If any of these||
8326|046|S|effects last or get worse, tell your doctor or pharmacist||
8326|047|S|promptly.||
8326|048|S|   Remember that this medication has been prescribed because your||
8326|049|S|doctor has judged that the benefit to you is greater than the||
8326|050|S|risk of side effects. Many people using this medication do not||
8326|051|S|have serious side effects.||
8326|052|S|   Tell your doctor right away if you have any serious side||
8326|053|S|effects, including: signs of liver disease (such as||
8326|054|S|nausea/vomiting that doesn't stop, loss of appetite, dark urine,||
8326|055|S|stomach/abdominal pain, yellowing eyes/skin), swelling||
8326|056|S|ankles/feet/hands, fast/irregular heartbeat, muscle cramps.||
8326|057|S|   A very serious allergic reaction to this drug is rare.||
8326|058|S|However, get medical help right away if you notice any symptoms||
8326|059|S|of a serious allergic reaction, including: rash, itching/swelling||
8326|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8326|061|S|breathing.||
8326|062|S|   This is not a complete list of possible side effects. If you||
8326|063|S|notice other effects not listed above, contact your doctor or||
8326|064|S|pharmacist.||
8326|065|S|   In the US -||
8326|066|S|   Call your doctor for medical advice about side effects. You||
8326|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8326|068|S|www.fda.gov/medwatch.||
8326|069|S|   In Canada - Call your doctor for medical advice about side||
8326|070|S|effects. You may report side effects to Health Canada at||
8326|071|S|1-866-234-2345.||
8326|072|B|||
8326|073|P|PRECAUTIONS:  Before using caspofungin, tell your doctor or||
8326|074|P|pharmacist if you are allergic to it; or to other echinocandin||
8326|075|P|antifungal drugs (such as anidulafungin, micafungin); or if you||
8326|076|P|have any other allergies. This product may contain inactive||
8326|077|P|ingredients, which can cause allergic reactions or other||
8326|078|P|problems. Talk to your pharmacist for more details.||
8326|079|P|   Before using this medication, tell your doctor or pharmacist||
8326|080|P|your medical history, especially of: liver disease.||
8326|081|P|   Before having surgery, tell your doctor or dentist about all||
8326|082|P|the products you use (including prescription drugs,||
8326|083|P|nonprescription drugs, and herbal products).||
8326|084|P|   During pregnancy, this medication should be used only when||
8326|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
8326|086|P|   It is unknown if this drug passes into breast milk. Consult||
8326|087|P|your doctor before breastfeeding.||
8326|088|B|||
8326|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8326|090|I|medications work or increase your risk for serious side effects.||
8326|091|I|This document does not contain all possible drug interactions.||
8326|092|I|Keep a list of all the products you use (including||
8326|093|I|prescription/nonprescription drugs and herbal products) and share||
8326|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
8326|095|I|the dosage of any medicines without your doctor's approval.||
8326|096|B|||
8326|097|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8326|098|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8326|099|O|poison control center right away. US residents can call||
8326|100|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8326|101|B|||
8326|102|N|NOTES:  Lab and/or medical tests (such as liver/kidney function,||
8326|103|N|potassium blood levels) should be done while you are using this||
8326|104|N|medication. Keep all medical and lab appointments. Consult your||
8326|105|N|doctor for more details.||
8326|106|B|||
8326|107|D|MISSED DOSE:  It is important to get each dose of this medication||
8326|108|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8326|109|D|right away for a new dosing schedule. Do not double the dose to||
8326|110|D|catch up.||
8326|111|B|||
8326|112|R|STORAGE:  Consult the product instructions and your pharmacist||
8326|113|R|for storage details. Keep all medications away from children and||
8326|114|R|pets.||
8326|115|R|   Do not flush medications down the toilet or pour them into a||
8326|116|R|drain unless instructed to do so. Properly discard this product||
8326|117|R|when it is expired or no longer needed. Consult your pharmacist||
8326|118|R|or local waste disposal company.||
8326|119|B|||
8326|120|A|Information last revised November 2024.||
8326|121|A|Copyright(c) 2025 First Databank, Inc.||
8326|122|B|||
8327|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8327|002|Z|does NOT have all possible information about this product. This||
8327|003|Z|information does not assure that this product is safe, effective,||
8327|004|Z|or appropriate for you. This information is not individual||
8327|005|Z|medical advice and does not substitute for the advice of your||
8327|006|Z|health care professional. Always ask your health care||
8327|007|Z|professional for complete information about this product and your||
8327|008|Z|specific health needs.||
8327|009|B|||
8327|010|T|EPIRUBICIN - INJECTION||
8327|011|F|(epp-ih-REWB-ih-sin)||
8327|012|B|||
8327|013|C|COMMON BRAND NAME(S): Ellence||
8327|014|B|||
8327|015|W|WARNING:  Epirubicin must be given only by injection slowly into||
8327|016|W|a vein. Do not inject into a muscle or under the skin. If this||
8327|017|W|medication accidentally leaks into the skin/muscle around the||
8327|018|W|injection site, it may cause severe damage. Tell your doctor||
8327|019|W|right away if you notice redness, pain, or swelling at or near||
8327|020|W|the injection site.||
8327|021|W|   This medication may rarely cause serious (rarely fatal) heart||
8327|022|W|problems (including heart failure). This may occur both during||
8327|023|W|treatment or months to years after treatment is completed. The||
8327|024|W|risk of heart problems is affected by your dose, medical history||
8327|025|W|(including previous heart disease, radiation treatment to the||
8327|026|W|chest area), and previous use of this and other drugs (including||
8327|027|W|doxorubicin). Tell your doctor right away if you notice symptoms||
8327|028|W|such as fast/slow/irregular heartbeat, shortness of breath,||
8327|029|W|swelling ankles/feet, unusual tiredness, or unusual/sudden weight||
8327|030|W|gain.||
8327|031|W|   Epirubicin may cause certain severe blood and bone marrow||
8327|032|W|disorders (low or abnormal red blood cells/white blood||
8327|033|W|cells/platelets). This can affect your body's ability to stop||
8327|034|W|bleeding or fight infection. Tell your doctor right away if you||
8327|035|W|develop unusual tiredness, easy bleeding/bruising, or signs of||
8327|036|W|infection (such as sore throat that doesn't go away, fever,||
8327|037|W|chills).||
8327|038|W|   Very rarely, people with cancer who are treated with this type||
8327|039|W|of medication have developed other cancers (such as secondary||
8327|040|W|leukemia). The risk may be increased when this medication is||
8327|041|W|given with certain anti-cancer drugs (especially in high doses)||
8327|042|W|or radiation treatment. Consult your doctor for more details.||
8327|043|B|||
8327|044|U|USES:  Epirubicin is used to treat breast cancer. It belongs to a||
8327|045|U|class of drugs known as anthracyclines and works by slowing or||
8327|046|U|stopping the growth of cancer cells.||
8327|047|B|||
8327|048|V|OTHER USES:  This section contains uses of this drug that are not||
8327|049|V|listed in the approved professional labeling for the drug but||
8327|050|V|that may be prescribed by your health care professional. Use this||
8327|051|V|drug for a condition that is listed in this section only if it||
8327|052|V|has been so prescribed by your health care professional.||
8327|053|V|   This drug may also be used for other cancers (such as bone||
8327|054|V|cancer).||
8327|055|B|||
8327|056|H|HOW TO USE:  This medication is given by injection into a vein by||
8327|057|H|a health care professional, as directed by your doctor. The||
8327|058|H|dosage is based on your medical condition, body size, and||
8327|059|H|response to treatment.||
8327|060|H|   If this medication touches your skin, immediately wash the||
8327|061|H|area well with plenty of water. You may also use soap and water||
8327|062|H|or a mixture of baking soda (sodium bicarbonate) in plenty of||
8327|063|H|water. If this medication gets in your eye, open the eyelids and||
8327|064|H|flush with water for 15 minutes, then get medical help right||
8327|065|H|away.||
8327|066|H|   Drink plenty of fluids while using this medication unless||
8327|067|H|otherwise directed by your doctor. Doing so helps decrease the||
8327|068|H|risk of certain side effects (such as increased uric acid).||
8327|069|B|||
8327|070|S|SIDE EFFECTS:  See also Warning section.||
8327|071|S|   Nausea, vomiting, diarrhea, abdominal pain, flushing, or||
8327|072|S|skin/nail color changes may occur. Nausea and vomiting can be||
8327|073|S|severe. In some cases, your doctor may prescribe medication to||
8327|074|S|prevent or relieve nausea and vomiting. Eating several small||
8327|075|S|meals, not eating before treatment, or limiting activity may help||
8327|076|S|lessen some of these effects. If these effects last or get worse,||
8327|077|S|tell your doctor or pharmacist promptly.||
8327|078|S|   This medication may cause your urine to turn a reddish color.||
8327|079|S|This is a normal, harmless effect of the drug that usually stops||
8327|080|S|within 2 days after each dose and should not be mistaken for||
8327|081|S|blood in your urine.||
8327|082|S|   Temporary hair loss is a common side effect. Normal hair||
8327|083|S|growth should return after treatment has ended.||
8327|084|S|   Remember that this medication has been prescribed because your||
8327|085|S|doctor has judged that the benefit to you is greater than the||
8327|086|S|risk of side effects. Many people using this medication do not||
8327|087|S|have serious side effects.||
8327|088|S|   Tell your doctor right away if you have any serious side||
8327|089|S|effects, including: menstrual changes (such as stopped periods),||
8327|090|S|unusual bleeding/bruising (such as small red spots on the skin,||
8327|091|S|black/bloody stools, bloody urine, vomit that looks like coffee||
8327|092|S|grounds).||
8327|093|S|   Pain or sores in the mouth and throat may occur. Brush your||
8327|094|S|teeth gently/carefully, avoid using mouthwash that contains||
8327|095|S|alcohol, and rinse your mouth often with cool water mixed with||
8327|096|S|baking soda or salt. It may also be best to eat soft, moist||
8327|097|S|foods.||
8327|098|S|   Severe nausea, vomiting, and diarrhea may rarely cause||
8327|099|S|dehydration. Contact your doctor promptly if you notice any||
8327|100|S|symptoms of dehydration such as unusual decreased urination,||
8327|101|S|unusual dry mouth/increased thirst, lack of tears,||
8327|102|S|dizziness/lightheadedness, or pale/wrinkled skin.||
8327|103|S|   Epirubicin sometimes causes side effects due to the rapid||
8327|104|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
8327|105|S|risk, your doctor may add a medication and tell you to drink||
8327|106|S|plenty of fluids. Tell your doctor right away if you have||
8327|107|S|symptoms such as: low back/side pain (flank pain), signs of||
8327|108|S|kidney problems (such as painful urination, pink/bloody urine,||
8327|109|S|change in the amount of urine), muscle spasms/weakness.||
8327|110|S|   Get medical help right away if you have any very serious side||
8327|111|S|effects, including: chest pain, coughing up blood, sudden||
8327|112|S|pain/swelling/redness usually in the leg.||
8327|113|S|   A very serious allergic reaction to this drug is rare.||
8327|114|S|However, get medical help right away if you notice any symptoms||
8327|115|S|of a serious allergic reaction, including: rash, itching/swelling||
8327|116|S|(especially of the face/tongue/throat), trouble breathing, severe||
8327|117|S|dizziness.||
8327|118|S|   This is not a complete list of possible side effects. If you||
8327|119|S|notice other effects not listed above, contact your doctor or||
8327|120|S|pharmacist.||
8327|121|S|   In the US -||
8327|122|S|   Call your doctor for medical advice about side effects. You||
8327|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8327|124|S|www.fda.gov/medwatch.||
8327|125|S|   In Canada - Call your doctor for medical advice about side||
8327|126|S|effects. You may report side effects to Health Canada at||
8327|127|S|1-866-234-2345.||
8327|128|B|||
8327|129|P|PRECAUTIONS:  Before using epirubicin, tell your doctor or||
8327|130|P|pharmacist if you are allergic to it; or to other anthracyclines||
8327|131|P|(such as doxorubicin); or to anthracenediones (such as||
8327|132|P|mitoxantrone); or if you have any other allergies. This product||
8327|133|P|may contain inactive ingredients, which can cause allergic||
8327|134|P|reactions or other problems. Talk to your pharmacist for more||
8327|135|P|details.||
8327|136|P|   Before using this medication, tell your doctor or pharmacist||
8327|137|P|your medical history, especially of: blood/bleeding disorders||
8327|138|P|(such as anemia, low blood cell counts), gout, heart disease||
8327|139|P|(such as heart failure, recent heart attack, fast/slow/irregular||
8327|140|P|heartbeat), kidney disease, liver disease, radiation treatment||
8327|141|P|(especially to chest area).||
8327|142|P|   Epirubicin can make you more likely to get infections or may||
8327|143|P|make current infections worse. Stay away from anyone who has an||
8327|144|P|infection that may easily spread (such as chickenpox, COVID-19,||
8327|145|P|measles, flu). Talk to your doctor if you have been exposed to an||
8327|146|P|infection or for more details.||
8327|147|P|   Tell your health care professional that you are using||
8327|148|P|epirubicin before having any immunizations/vaccinations. Avoid||
8327|149|P|contact with people who have recently received live vaccines||
8327|150|P|(such as flu vaccine inhaled through the nose).||
8327|151|P|   To lower your risk of getting cut, bruised, or injured, use||
8327|152|P|caution with sharp objects like razors and nail cutters, and||
8327|153|P|avoid activities such as contact sports.||
8327|154|P|   This medication may make you more sensitive to the sun. Limit||
8327|155|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
8327|156|P|sunscreen and wear protective clothing when outdoors. Tell your||
8327|157|P|doctor right away if you get sunburned or have skin||
8327|158|P|blisters/redness.||
8327|159|P|   Before having surgery, tell your doctor or dentist about all||
8327|160|P|the products you use (including prescription drugs,||
8327|161|P|nonprescription drugs, and herbal products).||
8327|162|P|   Older adults may be more sensitive to the side effects of this||
8327|163|P|drug.||
8327|164|P|   Children may be more sensitive to the side effects of this||
8327|165|P|drug, especially effects on the heart.||
8327|166|P|   This medication can affect menstruation in females and cause||
8327|167|P|premature menopause. Consult your doctor or pharmacist for||
8327|168|P|details.||
8327|169|P|   Tell your doctor if you are pregnant or plan to become||
8327|170|P|pregnant. You should not become pregnant while using epirubicin.||
8327|171|P|Epirubicin may harm an unborn baby. Your doctor should order a||
8327|172|P|pregnancy test before you start this medication. Women using this||
8327|173|P|medication should ask about reliable forms of birth control||
8327|174|P|during treatment and for 6 months after the last dose. Men using||
8327|175|P|this medication should ask about reliable forms of birth control||
8327|176|P|during treatment and for 3 months after the last dose. Men with||
8327|177|P|pregnant partners should use condoms during treatment and for at||
8327|178|P|least 7 days after the last dose. If you or your partner becomes||
8327|179|P|pregnant, talk to your doctor right away about the risks and||
8327|180|P|benefits of this medication.||
8327|181|P|   It is unknown if this drug passes into breast milk. Because of||
8327|182|P|the possible risk to the infant, breastfeeding is not recommended||
8327|183|P|while using this drug and for at least 7 days after the last||
8327|184|P|dose. Consult your doctor before breastfeeding.||
8327|185|B|||
8327|186|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8327|187|I|medications work or increase your risk for serious side effects.||
8327|188|I|This document does not contain all possible drug interactions.||
8327|189|I|Keep a list of all the products you use (including||
8327|190|I|prescription/nonprescription drugs and herbal products) and share||
8327|191|I|it with your doctor and pharmacist. Do not start, stop, or change||
8327|192|I|the dosage of any medicines without your doctor's approval.||
8327|193|I|   Some products that may interact with this drug include:||
8327|194|I|cimetidine, other drugs that may affect the heart (including||
8327|195|I|trastuzumab, anthracyclines such as doxorubicin).||
8327|196|B|||
8327|197|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8327|198|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8327|199|O|poison control center right away. US residents can call||
8327|200|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8327|201|B|||
8327|202|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
8327|203|N|liver/heart function) should be done before you start using this||
8327|204|N|medication and while you are using it. Keep all medical and lab||
8327|205|N|appointments. Consult your doctor for more details.||
8327|206|B|||
8327|207|D|MISSED DOSE:  It is important to get each dose of this medication||
8327|208|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8327|209|D|right away for a new dosing schedule.||
8327|210|B|||
8327|211|R|STORAGE:  Not applicable. This medication is given in a clinic||
8327|212|R|and will not be stored at home.||
8327|213|B|||
8327|214|M|MEDICAL ALERT:  Your condition can cause complications in a||
8327|215|M|medical emergency. For information about enrolling in MedicAlert,||
8327|216|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8327|217|B|||
8327|218|A|Information last revised October 2024.||
8327|219|A|Copyright(c) 2025 First Databank, Inc.||
8327|220|B|||
8330|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8330|002|Z|does NOT have all possible information about this product. This||
8330|003|Z|information does not assure that this product is safe, effective,||
8330|004|Z|or appropriate for you. This information is not individual||
8330|005|Z|medical advice and does not substitute for the advice of your||
8330|006|Z|health care professional. Always ask your health care||
8330|007|Z|professional for complete information about this product and your||
8330|008|Z|specific health needs.||
8330|009|B|||
8330|010|T|OSELTAMIVIR SUSPENSION - ORAL||
8330|011|F|(oss-el-TAM-eh-veer)||
8330|012|B|||
8330|013|C|COMMON BRAND NAME(S): Tamiflu||
8330|014|B|||
8330|015|U|USES:  Oseltamivir is used to treat symptoms caused by the flu||
8330|016|U|virus (influenza). It helps make the symptoms (such as stuffy||
8330|017|U|nose, cough, sore throat, fever/chills, aches, tiredness) less||
8330|018|U|severe and shortens the recovery time by 1-2 days.||
8330|019|U|   This medication may also be used to prevent the flu if you||
8330|020|U|have been exposed to someone who already has the flu (such as a||
8330|021|U|sick household member) or if there is a flu outbreak in the||
8330|022|U|community. Talk to your doctor for more details.||
8330|023|U|   This medication works by stopping the flu virus from growing.||
8330|024|U|It is not a substitute for the flu vaccine. (See also Notes||
8330|025|U|section.)||
8330|026|B|||
8330|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8330|028|H|from your pharmacist before you start taking this medicine. If||
8330|029|H|you have any questions, consult your doctor or pharmacist.||
8330|030|H|   Take this medication by mouth with or without food. You may||
8330|031|H|take it with food or milk to minimize stomach upset. Take this||
8330|032|H|medication as soon as flu symptoms appear or as soon as possible||
8330|033|H|after you have been exposed to the flu. Oseltamivir works best if||
8330|034|H|you start taking it within 2 days of either of these events.||
8330|035|H|   Shake the bottle well before each dose. Your pharmacist will||
8330|036|H|provide you with an oral dosing dispenser. Measure each dose||
8330|037|H|carefully using the device as instructed. Be careful not to||
8330|038|H|confuse the dose of oseltamivir in milligrams (mg) with the dose||
8330|039|H|in milliliters (ml). Your pharmacist should show you exactly how||
8330|040|H|much medication to use for each dose. Give the dose directly in||
8330|041|H|the mouth. Do not mix with other liquids. After each use, rinse||
8330|042|H|the dispenser with tap water and let it air dry. If you lose or||
8330|043|H|damage the dosing dispenser, consult your pharmacist on what oral||
8330|044|H|syringe you should use instead, and how to correctly measure the||
8330|045|H|dose.||
8330|046|H|   If you have the flu, take oseltamivir as directed by your||
8330|047|H|doctor, usually twice a day for 5 days.||
8330|048|H|   To prevent the flu, take oseltamivir as directed by your||
8330|049|H|doctor, usually once a day for at least 10 days. Follow your||
8330|050|H|doctor's instructions for how long to take this medicine.||
8330|051|H|   The dosage is based on your medical condition and response to||
8330|052|H|treatment. Children's dosage is also based on weight.||
8330|053|H|   For the best effect, take this medication at evenly spaced||
8330|054|H|times. To help you remember, take this medication at the same||
8330|055|H|time(s) every day. Continue to take this medication for the full||
8330|056|H|time prescribed, even if symptoms disappear after a few days.||
8330|057|H|Stopping the medication too early may result in a return of the||
8330|058|H|infection or failure to protect you from the flu.||
8330|059|H|   Tell your doctor if your condition lasts or gets worse or if||
8330|060|H|new symptoms appear.||
8330|061|B|||
8330|062|S|SIDE EFFECTS:  Nausea and vomiting may occur. If either of these||
8330|063|S|effects last or get worse, tell your doctor or pharmacist||
8330|064|S|promptly.||
8330|065|S|   Remember that this medication has been prescribed because your||
8330|066|S|doctor has judged that the benefit to you is greater than the||
8330|067|S|risk of side effects. Many people using this medication do not||
8330|068|S|have serious side effects.||
8330|069|S|   The flu itself or oseltamivir may rarely cause serious||
8330|070|S|mental/mood changes. This may be more likely in children. Tell||
8330|071|S|your doctor right away of any signs of unusual behavior,||
8330|072|S|including: confusion, agitation, self-injury.||
8330|073|S|   A very serious allergic reaction to this drug is rare.||
8330|074|S|However, get medical help right away if you notice any symptoms||
8330|075|S|of a serious allergic reaction, including: rash, itching/swelling||
8330|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8330|077|S|breathing.||
8330|078|S|   This is not a complete list of possible side effects. If you||
8330|079|S|notice other effects not listed above, contact your doctor or||
8330|080|S|pharmacist.||
8330|081|S|   In the US -||
8330|082|S|   Call your doctor for medical advice about side effects. You||
8330|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8330|084|S|www.fda.gov/medwatch.||
8330|085|S|   In Canada - Call your doctor for medical advice about side||
8330|086|S|effects. You may report side effects to Health Canada at||
8330|087|S|1-866-234-2345.||
8330|088|B|||
8330|089|P|PRECAUTIONS:  Before taking oseltamivir, tell your doctor or||
8330|090|P|pharmacist if you are allergic to it; or if you have any other||
8330|091|P|allergies. This product may contain inactive ingredients, which||
8330|092|P|can cause allergic reactions or other problems. Talk to your||
8330|093|P|pharmacist for more details.||
8330|094|P|   Before using this medication, tell your doctor or pharmacist||
8330|095|P|your medical history, especially of: kidney disease (including||
8330|096|P|dialysis treatment).||
8330|097|P|   The liquid form of this medication may contain sorbitol.||
8330|098|P|Sorbitol may cause upset stomach and diarrhea in people who have||
8330|099|P|problems with certain sugars (fructose intolerance). Your doctor||
8330|100|P|may need to order the capsule form of this medication if you||
8330|101|P|cannot tolerate sorbitol.||
8330|102|P|   Before having surgery, tell your doctor or dentist about all||
8330|103|P|the products you use (including prescription drugs,||
8330|104|P|nonprescription drugs, and herbal products).||
8330|105|P|   During pregnancy, this medication should be used only when||
8330|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
8330|107|P|   This medication passes into breast milk but is unlikely to||
8330|108|P|harm a nursing infant. Consult your doctor before breastfeeding.||
8330|109|B|||
8330|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8330|111|I|medications work or increase your risk for serious side effects.||
8330|112|I|This document does not contain all possible drug interactions.||
8330|113|I|Keep a list of all the products you use (including||
8330|114|I|prescription/nonprescription drugs and herbal products) and share||
8330|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
8330|116|I|the dosage of any medicines without your doctor's approval.||
8330|117|I|   Tell your doctor if you have received flu vaccine in the nose||
8330|118|I|within 2 weeks before treatment with this medication. This||
8330|119|I|medication may lower your protection from flu vaccine given in||
8330|120|I|the nose. Wait at least 2 days after ending treatment with this||
8330|121|I|medication before receiving flu vaccine given in the nose.||
8330|122|B|||
8330|123|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8330|124|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8330|125|O|poison control center right away. US residents can call||
8330|126|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8330|127|B|||
8330|128|N|NOTES:  Do not share this medication with others.||
8330|129|N|   This medication is not a substitute for the flu vaccine.||
8330|130|N|Consult your doctor about the risks and important benefits of||
8330|131|N|receiving a yearly flu shot to lower your chances of getting the||
8330|132|N|flu.||
8330|133|B|||
8330|134|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8330|135|D|remember. If it is within 2 hours of the next dose, skip the||
8330|136|D|missed dose. Take your next dose at the regular time. Do not||
8330|137|D|double the dose to catch up.||
8330|138|B|||
8330|139|R|STORAGE:  Store in the refrigerator. Do not freeze. Discard any||
8330|140|R|unused portion after 17 days. This medication may also be stored||
8330|141|R|at room temperature if needed. If the medication is stored at||
8330|142|R|room temperature, discard after 10 days. Keep all medications||
8330|143|R|away from children and pets.||
8330|144|R|   Do not flush medications down the toilet or pour them into a||
8330|145|R|drain unless instructed to do so. Properly discard this product||
8330|146|R|when it is expired or no longer needed. Consult your pharmacist||
8330|147|R|or local waste disposal company.||
8330|148|B|||
8330|149|A|Information last revised September 2024.||
8330|150|A|Copyright(c) 2025 First Databank, Inc.||
8330|151|B|||
8333|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8333|002|Z|does NOT have all possible information about this product. This||
8333|003|Z|information does not assure that this product is safe, effective,||
8333|004|Z|or appropriate for you. This information is not individual||
8333|005|Z|medical advice and does not substitute for the advice of your||
8333|006|Z|health care professional. Always ask your health care||
8333|007|Z|professional for complete information about this product and your||
8333|008|Z|specific health needs.||
8333|009|B|||
8333|010|T|HYDROCORTISONE SODIUM SUCCINATE - INJECTION||
8333|011|F|(HYE-droe-KOR-ti-sone SOE-dee-um SUX-i-nate)||
8333|012|B|||
8333|013|C|COMMON BRAND NAME(S): A-Hydrocort, Solu-Cortef||
8333|014|B|||
8333|015|U|USES:  This medication is used to treat various conditions such||
8333|016|U|as arthritis, severe allergies, blood diseases, breathing||
8333|017|U|problems, certain cancers, eye diseases, intestinal disorders,||
8333|018|U|and skin diseases. It weakens your immune system's response to||
8333|019|U|various diseases to reduce symptoms such as swelling and||
8333|020|U|allergic-type reactions. Hydrocortisone may also be used with||
8333|021|U|other medications to replace certain hormones if you have||
8333|022|U|decreased adrenal gland function or Addison's disease.||
8333|023|U|Hydrocortisone belongs to a class of drugs known as||
8333|024|U|corticosteroids.||
8333|025|U|   Hydrocortisone injection is used when a similar drug cannot be||
8333|026|U|taken by mouth or when a very fast treatment is needed for||
8333|027|U|patients with severe medical conditions. Talk to your doctor||
8333|028|U|about the risks and benefits of hydrocortisone, especially if it||
8333|029|U|is to be injected near your spine (epidural). Rare but serious||
8333|030|U|side effects may occur with epidural use.||
8333|031|B|||
8333|032|V|OTHER USES:  This section contains uses of this drug that are not||
8333|033|V|listed in the approved professional labeling for the drug but||
8333|034|V|that may be prescribed by your health care professional. Use this||
8333|035|V|drug for a condition that is listed in this section only if it||
8333|036|V|has been so prescribed by your health care professional.||
8333|037|V|   Hydrocortisone may also be used for COVID-19, but is only||
8333|038|V|effective in hospitalized patients who need supplemental oxygen||
8333|039|V|or a mechanical ventilator to breathe.||
8333|040|B|||
8333|041|H|HOW TO USE:  This medication is given by slow injection into a||
8333|042|H|vein or directly into a muscle, as directed by your doctor. The||
8333|043|H|dosage is based on your medical condition and response to||
8333|044|H|treatment.||
8333|045|H|   If you are using this medication at home, learn all||
8333|046|H|preparation and usage instructions from your health care||
8333|047|H|professional. Before using, check this product for particles or||
8333|048|H|discoloration. If either is present, do not use the liquid. Learn||
8333|049|H|how to store and discard medical supplies safely.||
8333|050|H|   Do not stop using this medication without consulting your||
8333|051|H|doctor. Some conditions may become worse when this drug is||
8333|052|H|suddenly stopped. Also, you may experience symptoms such as||
8333|053|H|weakness, weight loss, nausea, muscle pain, headache, tiredness,||
8333|054|H|dizziness. To prevent these symptoms while you are stopping||
8333|055|H|treatment with this drug, your doctor may reduce your dose||
8333|056|H|gradually. Consult your doctor or pharmacist for more details.||
8333|057|H|Report any new or worsening symptoms right away.||
8333|058|H|   Tell your doctor if you do not get better or if you get worse.||
8333|059|B|||
8333|060|S|SIDE EFFECTS:  Stomach upset, headache, dizziness, trouble||
8333|061|S|sleeping, appetite changes, menstrual period changes, acne, or||
8333|062|S|pain/redness/swelling at the injection site may occur. If any of||
8333|063|S|these effects last or get worse, tell your doctor or pharmacist||
8333|064|S|promptly.||
8333|065|S|   Remember that this medication has been prescribed because your||
8333|066|S|doctor has judged that the benefit to you is greater than the||
8333|067|S|risk of side effects. Many people using this medication do not||
8333|068|S|have serious side effects.||
8333|069|S|   This medication may raise your blood pressure. Check your||
8333|070|S|blood pressure regularly and tell your doctor if the results are||
8333|071|S|high.||
8333|072|S|   This medication may make your blood sugar rise, which can||
8333|073|S|cause or worsen diabetes. Tell your doctor right away if you have||
8333|074|S|symptoms of high blood sugar such as increased thirst/urination.||
8333|075|S|If you already have diabetes, check your blood sugar regularly as||
8333|076|S|directed and share the results with your doctor. Your doctor may||
8333|077|S|need to adjust your diabetes medication, exercise program, or||
8333|078|S|diet.||
8333|079|S|   This medication may lower your ability to fight infections.||
8333|080|S|This may make you more likely to get a serious (rarely fatal)||
8333|081|S|infection or make any infection you have worse. Tell your doctor||
8333|082|S|right away if you have any signs of infection (such as sore||
8333|083|S|throat that doesn't go away, fever, chills).||
8333|084|S|   Tell your doctor right away if you have any serious side||
8333|085|S|effects, such as: weakness, puffy face, muscle pain/cramps,||
8333|086|S|unusual weight gain, slow wound healing, thinning skin,||
8333|087|S|bone/joint pain, mental/mood changes (such as depression, mood||
8333|088|S|swings, agitation), easy bruising/bleeding, vision problems,||
8333|089|S|swelling ankles/feet/hands, fast/slow/irregular heartbeat,||
8333|090|S|unusual hair/skin growth, red/purple spots on the skin.||
8333|091|S|   Get medical help right away if you have any very serious side||
8333|092|S|effects, such as: symptoms of stomach/intestinal bleeding (such||
8333|093|S|as stomach/abdominal pain, black/tarry stools, vomit that looks||
8333|094|S|like coffee grounds), seizures.||
8333|095|S|   A very serious allergic reaction to this drug is rare.||
8333|096|S|However, get medical help right away if you notice any symptoms||
8333|097|S|of a serious allergic reaction, such as: rash, itching/swelling||
8333|098|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8333|099|S|breathing.||
8333|100|S|   This is not a complete list of possible side effects. If you||
8333|101|S|notice other effects not listed above, contact your doctor or||
8333|102|S|pharmacist.||
8333|103|S|   In the US -||
8333|104|S|   Call your doctor for medical advice about side effects. You||
8333|105|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8333|106|S|www.fda.gov/medwatch.||
8333|107|S|   In Canada - Call your doctor for medical advice about side||
8333|108|S|effects. You may report side effects to Health Canada at||
8333|109|S|1-866-234-2345.||
8333|110|B|||
8333|111|P|PRECAUTIONS:  Before using hydrocortisone, tell your doctor or||
8333|112|P|pharmacist if you are allergic to it; or if you have any other||
8333|113|P|allergies. This product may contain inactive ingredients, which||
8333|114|P|can cause allergic reactions or other problems. Talk to your||
8333|115|P|pharmacist for more details.||
8333|116|P|   Before using this medication, tell your doctor or pharmacist||
8333|117|P|your medical history, especially of: bleeding problems, blood||
8333|118|P|clots, bone loss (osteoporosis), diabetes, certain eye diseases||
8333|119|P|(such as cataracts, glaucoma, herpes infection of the eye), heart||
8333|120|P|problems (such as heart failure, recent heart attack), high blood||
8333|121|P|pressure, current/past infections (such as those caused by||
8333|122|P|fungus, herpes, tuberculosis, threadworm), kidney disease, liver||
8333|123|P|disease (such as hepatitis B), mental/mood conditions (such as||
8333|124|P|psychosis, anxiety, depression), stomach/intestinal problems||
8333|125|P|(such as diverticulitis, ulcer, ulcerative colitis), seizures,||
8333|126|P|thyroid problems, mineral imbalance (such as low levels of||
8333|127|P|potassium or calcium in the blood), a certain adrenal gland tumor||
8333|128|P|(pheochromocytoma).||
8333|129|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8333|130|P|can make you more dizzy. Do not drive, use machinery, or do||
8333|131|P|anything that needs alertness until you can do it safely. Talk to||
8333|132|P|your doctor if you are using marijuana (cannabis).||
8333|133|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
8333|134|P|while using this medicine may increase your risk for stomach||
8333|135|P|bleeding. Limit alcoholic beverages.||
8333|136|P|   Using corticosteroid medications for a long time can make it||
8333|137|P|more difficult for your body to respond to physical stress.||
8333|138|P|Before having surgery or emergency treatment, or if you get a||
8333|139|P|serious illness/injury, tell your doctor or dentist that you are||
8333|140|P|using this medication or have used this medication within the||
8333|141|P|past 12 months. Tell your doctor right away if you develop||
8333|142|P|unusual/extreme tiredness or weight loss. If you will be using||
8333|143|P|this medication for a long time, carry a warning card or medical||
8333|144|P|ID bracelet that identifies your use of this medication.||
8333|145|P|   This medication may mask signs of infection. It can make you||
8333|146|P|more likely to get infections or may make current infections||
8333|147|P|worse. Stay away from anyone who has an infection that may easily||
8333|148|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
8333|149|P|doctor if you have been exposed to an infection or for more||
8333|150|P|details.||
8333|151|P|   Tell your health care professional that you are using||
8333|152|P|hydrocortisone before having any immunizations, vaccinations, or||
8333|153|P|skin tests. Avoid contact with people who have recently received||
8333|154|P|live vaccines (such as flu vaccine inhaled through the nose).||
8333|155|P|   Older adults may be more sensitive to the side effects of this||
8333|156|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
8333|157|P|mental/mood changes (such as confusion).||
8333|158|P|   This medication may slow down a child's growth if used for a||
8333|159|P|long time. Consult the doctor or pharmacist for more details. See||
8333|160|P|the doctor regularly so your child's height and growth can be||
8333|161|P|checked.||
8333|162|P|   During pregnancy, this medication should be used only when||
8333|163|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
8333|164|P|risks and benefits with your doctor. Infants born to mothers who||
8333|165|P|use this medication for a long time may have hormone problems.||
8333|166|P|Tell your doctor right away if you notice symptoms such as||
8333|167|P|nausea/vomiting that doesn't stop, severe diarrhea, or weakness||
8333|168|P|in your newborn.||
8333|169|P|   This medication passes into breast milk but is unlikely to||
8333|170|P|harm a nursing infant. Consult your doctor before breastfeeding.||
8333|171|B|||
8333|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8333|173|I|medications work or increase your risk for serious side effects.||
8333|174|I|This document does not contain all possible drug interactions.||
8333|175|I|Keep a list of all the products you use (such as||
8333|176|I|prescription/nonprescription drugs and herbal products) and share||
8333|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
8333|178|I|the dosage of any medicines without your doctor's approval.||
8333|179|I|   Some products that may interact with this drug are:||
8333|180|I|aldesleukin, desmopressin, mifepristone, other drugs that can||
8333|181|I|cause bleeding/bruising (such as antiplatelet drugs like||
8333|182|I|clopidogrel, NSAIDs like ibuprofen/naproxen, "blood thinners"||
8333|183|I|like warfarin/dabigatran).||
8333|184|I|   Aspirin can increase the risk of bleeding when used with this||
8333|185|I|medication. However, if your doctor has told you to take low-dose||
8333|186|I|aspirin to prevent heart attack or stroke (usually 81-162||
8333|187|I|milligrams a day), you should keep taking the aspirin unless your||
8333|188|I|doctor tells you not to. Ask your doctor or pharmacist for more||
8333|189|I|details.||
8333|190|I|   This medication may interfere with certain lab tests (such as||
8333|191|I|skin tests), possibly causing false test results. Make sure lab||
8333|192|I|personnel and all your doctors know you use this drug.||
8333|193|B|||
8333|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8333|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8333|196|O|poison control center right away. US residents can call||
8333|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8333|198|B|||
8333|199|N|NOTES:  Do not share this medication with others.||
8333|200|N|   If you use this medication for a long time, lab and/or medical||
8333|201|N|tests (such as blood counts, blood sugar/mineral levels, blood||
8333|202|N|pressure, bone density tests, height/weight measurements, eye||
8333|203|N|exams, X-rays) should be done while you are using this||
8333|204|N|medication. Keep all medical and lab appointments. Consult your||
8333|205|N|doctor for more details.||
8333|206|N|   This medication may cause bone loss (osteoporosis) when used||
8333|207|N|for a long time. Lifestyle changes that may help reduce the risk||
8333|208|N|of bone problems include doing weight-bearing exercise, stopping||
8333|209|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
8333|210|N|D. Talk to your doctor for more details.||
8333|211|B|||
8333|212|D|MISSED DOSE:  It is important to get each dose of this medication||
8333|213|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8333|214|D|right away for a new dosing schedule. Do not double the dose to||
8333|215|D|catch up.||
8333|216|B|||
8333|217|R|STORAGE:  Store unmixed vials at room temperature away from||
8333|218|R|light. After mixing, use within time period indicated in product||
8333|219|R|instructions. Discard unused portion. Keep all medications away||
8333|220|R|from children and pets.||
8333|221|R|   Do not flush medications down the toilet or pour them into a||
8333|222|R|drain unless instructed to do so. Properly discard this product||
8333|223|R|when it is expired or no longer needed. Consult your pharmacist||
8333|224|R|or local waste disposal company.||
8333|225|B|||
8333|226|A|Information last revised September 2025.||
8333|227|A|Copyright(c) 2025 First Databank, Inc.||
8333|228|B|||
8336|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8336|002|Z|does NOT have all possible information about this product. This||
8336|003|Z|information does not assure that this product is safe, effective,||
8336|004|Z|or appropriate for you. This information is not individual||
8336|005|Z|medical advice and does not substitute for the advice of your||
8336|006|Z|health care professional. Always ask your health care||
8336|007|Z|professional for complete information about this product and your||
8336|008|Z|specific health needs.||
8336|009|B|||
8336|010|T|LIDOCAINE SOLUTION - MUCOUS MEMBRANE||
8336|011|F|(LYE-doe-kane)||
8336|012|B|||
8336|013|C|COMMON BRAND NAME(S): Xylocaine||
8336|014|B|||
8336|015|U|USES:  This medication is used to relieve pain and discomfort||
8336|016|U|caused by certain mouth, nose, and throat problems. It is also||
8336|017|U|used to numb the lining of the mouth, throat, or nose before||
8336|018|U|certain medical procedures. It helps prevent the urge to close||
8336|019|U|the throat (gag reflex), which might make the procedure more||
8336|020|U|difficult. Lidocaine belongs to a class of drugs known as local||
8336|021|U|anesthetics.||
8336|022|U|   This product should not be used to treat teething pain in||
8336|023|U|infants and young children due to an increased risk of serious||
8336|024|U|side effects. Talk to the doctor for more details and for other||
8336|025|U|ways to treat teething pain.||
8336|026|B|||
8336|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8336|028|H|from your pharmacist before you start using lidocaine and each||
8336|029|H|time you get a refill. If you have any questions, ask your doctor||
8336|030|H|or pharmacist.||
8336|031|H|   This medication is usually applied by a health care||
8336|032|H|professional as directed by your doctor right before your||
8336|033|H|procedure.||
8336|034|H|   This medication may be used as a spray by putting the solution||
8336|035|H|into a special spray bottle (atomizer) or nebulizer. It can also||
8336|036|H|be applied directly to the affected area with a sterile||
8336|037|H|applicator or swab. Throw away the applicator or swab after use.||
8336|038|H|   If you are using this medication at home, learn all||
8336|039|H|preparation and usage instructions from your health care||
8336|040|H|professional and the product package. Follow your doctor's||
8336|041|H|instructions carefully. Do not swallow or gargle the medication||
8336|042|H|unless directed to do so by your doctor.||
8336|043|H|   The dosage is based on your medical condition and response to||
8336|044|H|treatment. Children's dosage is also based on age and weight. Do||
8336|045|H|not increase your dose or use this drug more often or for longer||
8336|046|H|than prescribed. Doing so can increase your risk of serious side||
8336|047|H|effects.||
8336|048|H|   When this medication is used in the mouth or throat, numbness||
8336|049|H|may make swallowing difficult and increase your risk of||
8336|050|H|swallowing the wrong way or choking. Do not chew gum or eat for 1||
8336|051|H|hour after using this product and while your mouth or throat is||
8336|052|H|numb. It is especially important for children to not eat or chew||
8336|053|H|gum for at least 1 hour after using this product. Be careful not||
8336|054|H|to accidentally bite your tongue or mouth.||
8336|055|H|   Lidocaine starts to numb the affected area within 5 minutes||
8336|056|H|after application. If you are using this product before certain||
8336|057|H|procedures, tell your doctor if the area does not feel numb or||
8336|058|H|the numbness does not go away. If you are using this product to||
8336|059|H|relieve pain/discomfort, tell your doctor if your condition lasts||
8336|060|H|or gets worse.||
8336|061|B|||
8336|062|S|SIDE EFFECTS:  Mild nausea, stinging, swelling, or burning may||
8336|063|S|occur. If any of these effects last or get worse, tell your||
8336|064|S|doctor or pharmacist promptly.||
8336|065|S|   Remember that this medication has been prescribed because your||
8336|066|S|doctor has judged that the benefit to you is greater than the||
8336|067|S|risk of side effects. Many people using this medication do not||
8336|068|S|have serious side effects.||
8336|069|S|   This medication may cause very serious side effects if you are||
8336|070|S|using too much of it or are very sensitive to its effects. Stop||
8336|071|S|using this medication and get medical help right away if you have||
8336|072|S|any very serious side effects, including: dizziness, drowsiness,||
8336|073|S|slow/shallow breathing, mental/mood changes (such as confusion,||
8336|074|S|nervousness), shaking, seizures, vision changes (such as||
8336|075|S|double/blurred vision), ringing in the ears, fainting,||
8336|076|S|pale/bluish/gray skin, unusual tiredness, shortness of breath,||
8336|077|S|fast/slow/irregular heartbeat.||
8336|078|S|   A very serious allergic reaction to this drug is rare.||
8336|079|S|However, get medical help right away if you notice any symptoms||
8336|080|S|of a serious allergic reaction, including: rash, itching/swelling||
8336|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8336|082|S|breathing.||
8336|083|S|   This is not a complete list of possible side effects. If you||
8336|084|S|notice other effects not listed above, contact your doctor or||
8336|085|S|pharmacist.||
8336|086|S|   In the US -||
8336|087|S|   Call your doctor for medical advice about side effects. You||
8336|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8336|089|S|www.fda.gov/medwatch.||
8336|090|S|   In Canada - Call your doctor for medical advice about side||
8336|091|S|effects. You may report side effects to Health Canada at||
8336|092|S|1-866-234-2345.||
8336|093|B|||
8336|094|P|PRECAUTIONS:  Before using lidocaine, tell your doctor or||
8336|095|P|pharmacist if you are allergic to it; or to other anesthetics||
8336|096|P|(such as bupivacaine, prilocaine); or to PABA; or if you have any||
8336|097|P|other allergies. This product may contain inactive ingredients,||
8336|098|P|which can cause allergic reactions or other problems. Talk to||
8336|099|P|your pharmacist for more details.||
8336|100|P|   Before using this medication, tell your doctor or pharmacist||
8336|101|P|your medical history, especially of: cuts/sores/bleeding in the||
8336|102|P|area where this drug will be applied, heart problems (such as||
8336|103|P|slow/irregular heartbeat, heart block), kidney disease, liver||
8336|104|P|disease, a certain blood disorder (methemoglobinemia).||
8336|105|P|   This drug may make you dizzy or drowsy or cause vision||
8336|106|P|problems if you are using too much of it or are very sensitive to||
8336|107|P|its effects. See Side Effects section. Alcohol or marijuana||
8336|108|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8336|109|P|machinery, or do anything that needs alertness or clear vision||
8336|110|P|until you can do it safely. Limit alcoholic beverages. Talk to||
8336|111|P|your doctor if you are using marijuana (cannabis).||
8336|112|P|   Before having surgery, tell your doctor or dentist about all||
8336|113|P|the products you use (including prescription drugs,||
8336|114|P|nonprescription drugs, and herbal products).||
8336|115|P|   Children may be more sensitive to the side effects of this||
8336|116|P|drug, especially drowsiness and dizziness.||
8336|117|P|   During pregnancy, this medication should be used only when||
8336|118|P|clearly needed. Discuss the risks and benefits with your doctor.||
8336|119|P|   This medication passes into breast milk, but is unlikely to||
8336|120|P|harm a nursing infant. Consult your doctor before breastfeeding.||
8336|121|B|||
8336|122|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8336|123|I|medications work or increase your risk for serious side effects.||
8336|124|I|This document does not contain all possible drug interactions.||
8336|125|I|Keep a list of all the products you use (including||
8336|126|I|prescription/nonprescription drugs and herbal products) and share||
8336|127|I|it with your doctor and pharmacist. Do not start, stop, or change||
8336|128|I|the dosage of any medicines without your doctor's approval.||
8336|129|I|   Tell your doctor or pharmacist if you are using other||
8336|130|I|lidocaine products at the same time as this medication because||
8336|131|I|your risk of serious side effects may increase.||
8336|132|B|||
8336|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8336|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8336|135|O|poison control center right away. US residents can call||
8336|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8336|137|O|Symptoms of overdose may include: vision/hearing changes, severe||
8336|138|O|dizziness/drowsiness, fainting, loss of consciousness, shaking,||
8336|139|O|seizures, slow/irregular heartbeat, slow/shallow breathing.||
8336|140|B|||
8336|141|N|NOTES:  Do not share this medication with others.||
8336|142|N|   This medication has been prescribed for your current condition||
8336|143|N|only. Do not use it later for another condition unless your||
8336|144|N|doctor directs you to do so. A different medication may be||
8336|145|N|necessary in that case.||
8336|146|B|||
8336|147|D|MISSED DOSE:  Not applicable.||
8336|148|B|||
8336|149|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
8336|150|R|medications away from children and pets.||
8336|151|R|   Do not flush medications down the toilet or pour them into a||
8336|152|R|drain unless instructed to do so. Properly discard this product||
8336|153|R|when it is expired or no longer needed. Consult your pharmacist||
8336|154|R|or local waste disposal company.||
8336|155|B|||
8336|156|A|Information last revised January 2025.||
8336|157|A|Copyright(c) 2025 First Databank, Inc.||
8336|158|B|||
8338|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8338|002|Z|does NOT have all possible information about this product. This||
8338|003|Z|information does not assure that this product is safe, effective,||
8338|004|Z|or appropriate for you. This information is not individual||
8338|005|Z|medical advice and does not substitute for the advice of your||
8338|006|Z|health care professional. Always ask your health care||
8338|007|Z|professional for complete information about this product and your||
8338|008|Z|specific health needs.||
8338|009|B|||
8338|010|T|FULVESTRANT - INJECTION||
8338|011|F|(ful-VES-trant)||
8338|012|B|||
8338|013|C|COMMON BRAND NAME(S): Faslodex||
8338|014|B|||
8338|015|U|USES:  Fulvestrant is used to treat certain types of breast||
8338|016|U|cancer. Breast cancer cells need the hormone estrogen in order to||
8338|017|U|grow. Fulvestrant works by blocking the effect of estrogen,||
8338|018|U|slowing tumor cell growth.||
8338|019|B|||
8338|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8338|021|H|from your pharmacist before you start using fulvestrant and each||
8338|022|H|time you get a refill. If you have any questions, ask your doctor||
8338|023|H|or pharmacist.||
8338|024|H|   This medication is given by slow injection into the buttock||
8338|025|H|muscle by a health care professional. It is given as directed by||
8338|026|H|your doctor, usually every 2 weeks for the first 3 doses and then||
8338|027|H|monthly. The dosage is based on your medical condition.||
8338|028|B|||
8338|029|S|SIDE EFFECTS:  Pain/swelling/redness at the injection site,||
8338|030|S|nausea/vomiting, loss of appetite, constipation, diarrhea, upset||
8338|031|S|stomach, dizziness, tiredness, headache, hot flashes, or trouble||
8338|032|S|sleeping may occur. If any of these effects last or get worse,||
8338|033|S|tell your doctor or pharmacist promptly.||
8338|034|S|   Remember that this medication has been prescribed because your||
8338|035|S|doctor has judged that the benefit to you is greater than the||
8338|036|S|risk of side effects. Many people using this medication do not||
8338|037|S|have serious side effects.||
8338|038|S|   Tell your doctor right away if you have any serious side||
8338|039|S|effects, including: numbness/tingling of arms/legs, back/leg||
8338|040|S|pain, bone/joint pain, mental/mood changes (such as anxiety,||
8338|041|S|depression), shortness of breath, cough that doesn't go away,||
8338|042|S|burning/painful/frequent urination, unusual tiredness, signs of||
8338|043|S|infection (such as sore throat that doesn't go away, fever,||
8338|044|S|chills).||
8338|045|S|   A very serious allergic reaction to this drug is rare.||
8338|046|S|However, get medical help right away if you notice any symptoms||
8338|047|S|of a serious allergic reaction, including: rash, itching/swelling||
8338|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8338|049|S|breathing.||
8338|050|S|   This is not a complete list of possible side effects. If you||
8338|051|S|notice other effects not listed above, contact your doctor or||
8338|052|S|pharmacist.||
8338|053|S|   In the US -||
8338|054|S|   Call your doctor for medical advice about side effects. You||
8338|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8338|056|S|www.fda.gov/medwatch.||
8338|057|S|   In Canada - Call your doctor for medical advice about side||
8338|058|S|effects. You may report side effects to Health Canada at||
8338|059|S|1-866-234-2345.||
8338|060|B|||
8338|061|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
8338|062|P|pharmacist if you are allergic to it; or if you have any other||
8338|063|P|allergies. This product may contain inactive ingredients (such as||
8338|064|P|benzyl alcohol), which can cause allergic reactions or other||
8338|065|P|problems. Talk to your pharmacist for more details.||
8338|066|P|   Before using this medication, tell your doctor or pharmacist||
8338|067|P|your medical history, especially of: liver disease, bleeding||
8338|068|P|problems, low platelet counts (thrombocytopenia).||
8338|069|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8338|070|P|can make you more dizzy. Do not drive, use machinery, or do||
8338|071|P|anything that needs alertness until you can do it safely. Limit||
8338|072|P|alcoholic beverages. Talk to your doctor if you are using||
8338|073|P|marijuana (cannabis).||
8338|074|P|   Before having surgery, tell your doctor or dentist about all||
8338|075|P|the products you use (including prescription drugs,||
8338|076|P|nonprescription drugs, and herbal products).||
8338|077|P|   Tell your doctor if you are pregnant or plan to become||
8338|078|P|pregnant. You should not become pregnant while using fulvestrant.||
8338|079|P|Fulvestrant may harm an unborn baby. Your doctor should order a||
8338|080|P|pregnancy test within 7 days of starting this medication. Ask||
8338|081|P|about reliable forms of non-hormonal birth control (such as||
8338|082|P|condoms, diaphragm with spermicide) while using this medication||
8338|083|P|and for 1 year after the last dose. If you become pregnant, talk||
8338|084|P|to your doctor right away about the risks and benefits of this||
8338|085|P|medication.||
8338|086|P|   It is unknown if this drug passes into breast milk. Because of||
8338|087|P|the possible risk to the infant, breastfeeding is not recommended||
8338|088|P|while using this drug and for 1 year after the last dose. Consult||
8338|089|P|your doctor before breastfeeding.||
8338|090|B|||
8338|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8338|092|I|medications work or increase your risk for serious side effects.||
8338|093|I|This document does not contain all possible drug interactions.||
8338|094|I|Keep a list of all the products you use (including||
8338|095|I|prescription/nonprescription drugs and herbal products) and share||
8338|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
8338|097|I|the dosage of any medicines without your doctor's approval.||
8338|098|I|   This medication may interfere with certain lab tests (such as||
8338|099|I|estradiol levels), possibly causing false test results. Make sure||
8338|100|I|lab personnel and all your doctors know you use this drug.||
8338|101|B|||
8338|102|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8338|103|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8338|104|O|poison control center right away. US residents can call||
8338|105|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8338|106|B|||
8338|107|N|NOTES:  Lab and/or medical tests (such as liver function) should||
8338|108|N|be done while you are using this medication. Keep all medical and||
8338|109|N|lab appointments. Consult your doctor for more details.||
8338|110|B|||
8338|111|D|MISSED DOSE:  It is important to get each dose of this medication||
8338|112|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8338|113|D|right away for a new dosing schedule.||
8338|114|B|||
8338|115|R|STORAGE:  Not applicable. This medication is given in a clinic or||
8338|116|R|doctor's office and will not be stored at home.||
8338|117|R|   Do not flush medications down the toilet or pour them into a||
8338|118|R|drain unless instructed to do so. Properly discard this product||
8338|119|R|when it is expired or no longer needed. Consult your pharmacist||
8338|120|R|or local waste disposal company.||
8338|121|B|||
8338|122|A|Information last revised May 2024.||
8338|123|A|Copyright(c) 2025 First Databank, Inc.||
8338|124|B|||
8343|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8343|002|Z|does NOT have all possible information about this product. This||
8343|003|Z|information does not assure that this product is safe, effective,||
8343|004|Z|or appropriate for you. This information is not individual||
8343|005|Z|medical advice and does not substitute for the advice of your||
8343|006|Z|health care professional. Always ask your health care||
8343|007|Z|professional for complete information about this product and your||
8343|008|Z|specific health needs.||
8343|009|B|||
8343|010|T|SODIUM FERRIC GLUCONATE COMPLEX - INJECTION||
8343|011|F|(SOE-dee-um FER-ik GLOO-koe-nate)||
8343|012|B|||
8343|013|C|COMMON BRAND NAME(S): Ferrlecit||
8343|014|B|||
8343|015|U|USES:  This medication is used to treat "iron-poor" blood||
8343|016|U|(anemia) in people with long-term kidney disease and using a||
8343|017|U|certain class of drug (man-made form of erythropoietin). You may||
8343|018|U|need extra iron because of blood loss during kidney dialysis.||
8343|019|U|Your body may also need more iron to help erythropoietin make new||
8343|020|U|red blood cells.||
8343|021|U|   Iron is an important part of your red blood cells and is||
8343|022|U|needed to transport oxygen in the body. Many people with kidney||
8343|023|U|disease cannot get enough iron from food and require injections.||
8343|024|B|||
8343|025|H|HOW TO USE:  This medication is given by injection slowly into a||
8343|026|H|vein or into your dialysis line by a health care professional.||
8343|027|H|   Severe dizziness or fainting (hypotension) may occur while you||
8343|028|H|are receiving iron given by injection. This may be helped by||
8343|029|H|giving the medication more slowly or at a lower dose. Follow your||
8343|030|H|doctor's directions carefully.||
8343|031|H|   The dosage is based on your medical condition, response to||
8343|032|H|treatment, and lab tests.||
8343|033|H|   If you are using this medication at home, learn all||
8343|034|H|preparation and usage instructions from your health care||
8343|035|H|professional. Before using, check this product for particles or||
8343|036|H|discoloration. If either is present, do not use the liquid. Learn||
8343|037|H|how to store and discard medical supplies safely.||
8343|038|B|||
8343|039|S|SIDE EFFECTS:  Nausea, vomiting, flushing, headache, diarrhea,||
8343|040|S|cramps, or discomfort at the injection site may occur. If any of||
8343|041|S|these effects last or get worse, tell your doctor or pharmacist||
8343|042|S|promptly.||
8343|043|S|   Remember that this medication has been prescribed because your||
8343|044|S|doctor has judged that the benefit to you is greater than the||
8343|045|S|risk of side effects. Many people using this medication do not||
8343|046|S|have serious side effects.||
8343|047|S|   Tell your doctor right away if you have any serious side||
8343|048|S|effects, including: dizziness/lightheadedness, muscle pain||
8343|049|S|(especially in the lower back/buttocks/legs), tingling of||
8343|050|S|hands/feet, unusual weakness, chest pain.||
8343|051|S|   A very serious allergic reaction to this drug is rare.||
8343|052|S|However, get medical help right away if you notice any symptoms||
8343|053|S|of a serious allergic reaction, including: rash, itching/swelling||
8343|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8343|055|S|breathing.||
8343|056|S|   This is not a complete list of possible side effects. If you||
8343|057|S|notice other effects not listed above, contact your doctor or||
8343|058|S|pharmacist.||
8343|059|S|   In the US -||
8343|060|S|   Call your doctor for medical advice about side effects. You||
8343|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8343|062|S|www.fda.gov/medwatch.||
8343|063|S|   In Canada - Call your doctor for medical advice about side||
8343|064|S|effects. You may report side effects to Health Canada at||
8343|065|S|1-866-234-2345.||
8343|066|B|||
8343|067|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
8343|068|P|pharmacist if you are allergic to it; or if you have any other||
8343|069|P|allergies. This product may contain inactive ingredients, which||
8343|070|P|can cause allergic reactions or other problems. Talk to your||
8343|071|P|pharmacist for more details.||
8343|072|P|   Before using this medication, tell your doctor or pharmacist||
8343|073|P|your medical history, especially of: low blood pressure, certain||
8343|074|P|metabolic disorders (such as hemochromatosis, hemosiderosis),||
8343|075|P|previous reactions to other iron products given by injection.||
8343|076|P|   Before having surgery, tell your doctor or dentist about all||
8343|077|P|the products you use (including prescription drugs,||
8343|078|P|nonprescription drugs, and herbal products).||
8343|079|P|   Tell your doctor if you are pregnant before using this||
8343|080|P|medication.||
8343|081|P|   It is unknown if this medication passes into breast milk.||
8343|082|P|Consult your doctor before breastfeeding.||
8343|083|B|||
8343|084|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8343|085|I|medications work or increase your risk for serious side effects.||
8343|086|I|This document does not contain all possible drug interactions.||
8343|087|I|Keep a list of all the products you use (including||
8343|088|I|prescription/nonprescription drugs and herbal products) and share||
8343|089|I|it with your doctor and pharmacist. Do not start, stop, or change||
8343|090|I|the dosage of any medicines without your doctor's approval.||
8343|091|B|||
8343|092|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8343|093|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8343|094|O|poison control center right away. US residents can call||
8343|095|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8343|096|O|Symptoms of overdose may include: severe stomach pain, vomiting,||
8343|097|O|pale/bluish skin (especially the lips/fingers/toes), rapid||
8343|098|O|breathing.||
8343|099|B|||
8343|100|N|NOTES:  Lab tests (such as complete blood count, ferritin levels)||
8343|101|N|should be done while you are using this medication. Keep all||
8343|102|N|medical and lab appointments. Consult your doctor for more||
8343|103|N|details.||
8343|104|N|   Remember that it is best to get your vitamins and minerals||
8343|105|N|from food whenever possible. Maintain a well-balanced diet, and||
8343|106|N|follow any dietary guidelines as directed by your doctor. Foods||
8343|107|N|rich in iron include meats (especially liver), eggs, raisins,||
8343|108|N|figs, broccoli, brussels sprouts, beans, lentils, and||
8343|109|N|iron-fortified or enriched cereals.||
8343|110|B|||
8343|111|D|MISSED DOSE:  It is important to get each dose of this medication||
8343|112|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
8343|113|D|right away for a new dosing schedule. Do not double the dose to||
8343|114|D|catch up.||
8343|115|B|||
8343|116|R|STORAGE:  Consult the product instructions and your pharmacist||
8343|117|R|for storage details. Keep all medications away from children and||
8343|118|R|pets.||
8343|119|R|   Do not flush medications down the toilet or pour them into a||
8343|120|R|drain unless instructed to do so. Properly discard this product||
8343|121|R|when it is expired or no longer needed. Consult your pharmacist||
8343|122|R|or local waste disposal company.||
8343|123|B|||
8343|124|A|Information last revised November 2024.||
8343|125|A|Copyright(c) 2025 First Databank, Inc.||
8343|126|B|||
8347|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8347|002|Z|does NOT have all possible information about this product. This||
8347|003|Z|information does not assure that this product is safe, effective,||
8347|004|Z|or appropriate for you. This information is not individual||
8347|005|Z|medical advice and does not substitute for the advice of your||
8347|006|Z|health care professional. Always ask your health care||
8347|007|Z|professional for complete information about this product and your||
8347|008|Z|specific health needs.||
8347|009|B|||
8347|010|T|ZOLMITRIPTAN SPRAY - NASAL||
8347|011|F|(ZOLE-mi-TRIP-tan)||
8347|012|B|||
8347|013|C|COMMON BRAND NAME(S): Zomig||
8347|014|B|||
8347|015|U|USES:  Zolmitriptan is used to treat migraines. It helps to||
8347|016|U|relieve headache, pain, and other migraine symptoms (including||
8347|017|U|nausea, vomiting, sensitivity to light/sound). Prompt treatment||
8347|018|U|helps you return to your normal routine and may decrease your||
8347|019|U|need for other pain medications. Zolmitriptan belongs to a class||
8347|020|U|of drugs known as triptans. It affects a certain natural||
8347|021|U|substance (serotonin) that causes narrowing of blood vessels in||
8347|022|U|the brain. It may also relieve pain by affecting certain nerves||
8347|023|U|in the brain.||
8347|024|U|   Zolmitriptan does not prevent future migraines or lessen how||
8347|025|U|often you get migraine attacks.||
8347|026|B|||
8347|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8347|028|H|from your pharmacist before you start using zolmitriptan spray||
8347|029|H|and each time you get a refill. If you have any questions, ask||
8347|030|H|your doctor or pharmacist.||
8347|031|H|   Use this medication at the first sign of a migraine as||
8347|032|H|directed by your doctor, usually 1 spray into one nostril. Avoid||
8347|033|H|spraying into your eyes. Blow your nose gently before using this||
8347|034|H|medication. Remove the protective cap, and block one nostril by||
8347|035|H|pressing firmly on either side of your nose. Place the tip of the||
8347|036|H|spray device into the other nostril and breathe in gently as you||
8347|037|H|press the plunger. Keep your head tilted slightly back, remove||
8347|038|H|the tip from your nose, and breathe gently through your mouth for||
8347|039|H|5 to 10 seconds. Your nose may feel wet inside and you may notice||
8347|040|H|a slight taste after using the spray. This is normal.||
8347|041|H|   If there is no improvement in your symptoms, do not take more||
8347|042|H|doses of this medication before talking to your doctor. If your||
8347|043|H|symptoms are only partly relieved, or if your headache comes||
8347|044|H|back, you may use another dose at least two hours after the first||
8347|045|H|dose. Do not use more than 10 milligrams in a 24-hour period.||
8347|046|H|   The dosage is based on your medical condition, response to||
8347|047|H|treatment, and other medications you may be taking. Be sure to||
8347|048|H|tell your doctor about all the products you use, including||
8347|049|H|prescription drugs, nonprescription drugs, and herbal products.||
8347|050|H|   If you have a higher risk for heart problems (see||
8347|051|H|Precautions), your doctor may perform a heart exam before you||
8347|052|H|start taking zolmitriptan. He/she may also direct you to take||
8347|053|H|your first dose of this medication in the office/clinic to||
8347|054|H|monitor for serious side effects (such as chest pain). Talk to||
8347|055|H|your doctor for details.||
8347|056|H|   If you are using drugs for migraine attacks on 10 or more days||
8347|057|H|each month, the drugs may actually make your headaches worse||
8347|058|H|(medication overuse headache). Do not use medications more often||
8347|059|H|or for longer than directed. Tell your doctor if you need to use||
8347|060|H|this medication more often, or if the medication is not working||
8347|061|H|as well, or if your headaches get worse.||
8347|062|B|||
8347|063|S|SIDE EFFECTS:  Unusual taste, dry mouth, discomfort in the nose,||
8347|064|S|tingling/numbness, nausea, weakness, drowsiness, or dizziness may||
8347|065|S|occur. If any of these effects last or get worse, tell your||
8347|066|S|doctor or pharmacist promptly.||
8347|067|S|   Remember that this medication has been prescribed because your||
8347|068|S|doctor has judged that the benefit to you is greater than the||
8347|069|S|risk of side effects. Many people using this medication do not||
8347|070|S|have serious side effects.||
8347|071|S|   This medication may raise your blood pressure. Check your||
8347|072|S|blood pressure regularly and tell your doctor if the results are||
8347|073|S|high.||
8347|074|S|   Tell your doctor right away if you have any serious side||
8347|075|S|effects, including: blue fingers/toes/nails, cold hands/feet.||
8347|076|S|   Zolmitriptan can commonly cause chest/jaw/neck tightness,||
8347|077|S|pain, or pressure that is usually not serious. However, these||
8347|078|S|side effects are like symptoms of a heart attack, which may||
8347|079|S|include chest/jaw/left arm pain, shortness of breath, or unusual||
8347|080|S|sweating. Get medical help right away if these or other serious||
8347|081|S|side effects occur, including: fast/irregular heartbeat,||
8347|082|S|fainting, severe stomach/abdominal pain, bloody diarrhea, signs||
8347|083|S|of a stroke (such as weakness on one side of the body, trouble||
8347|084|S|speaking, sudden vision changes, confusion).||
8347|085|S|   This medication may increase serotonin and rarely cause a very||
8347|086|S|serious condition called serotonin syndrome/toxicity. The risk||
8347|087|S|increases if you are also taking other drugs that increase||
8347|088|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
8347|089|S|take (see Drug Interactions section). Get medical help right away||
8347|090|S|if you develop some of the following symptoms: fast heartbeat,||
8347|091|S|hallucinations, loss of coordination, severe dizziness, severe||
8347|092|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
8347|093|S|unusual agitation/restlessness.||
8347|094|S|   A very serious allergic reaction to this drug is rare.||
8347|095|S|However, get medical help right away if you notice any symptoms||
8347|096|S|of a serious allergic reaction, including: rash, itching/swelling||
8347|097|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8347|098|S|breathing.||
8347|099|S|   This is not a complete list of possible side effects. If you||
8347|100|S|notice other effects not listed above, contact your doctor or||
8347|101|S|pharmacist.||
8347|102|S|   In the US -||
8347|103|S|   Call your doctor for medical advice about side effects. You||
8347|104|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8347|105|S|www.fda.gov/medwatch.||
8347|106|S|   In Canada - Call your doctor for medical advice about side||
8347|107|S|effects. You may report side effects to Health Canada at||
8347|108|S|1-866-234-2345.||
8347|109|B|||
8347|110|P|PRECAUTIONS:  Before using zolmitriptan, tell your doctor or||
8347|111|P|pharmacist if you are allergic to it; or if you have any other||
8347|112|P|allergies. This product may contain inactive ingredients, which||
8347|113|P|can cause allergic reactions or other problems. Talk to your||
8347|114|P|pharmacist for more details.||
8347|115|P|   Before using this medication, tell your doctor or pharmacist||
8347|116|P|your medical history, especially of: blood circulation problems||
8347|117|P|(for example, in your legs, arms/hands, or stomach), certain||
8347|118|P|types of headaches (hemiplegic or basilar migraine), heart||
8347|119|P|problems (such as chest pain, irregular heartbeat, previous heart||
8347|120|P|attack), liver disease, seizure, stroke or "mini-stroke"||
8347|121|P|(transient ischemic attack).||
8347|122|P|   Certain conditions can increase your risk for heart problems.||
8347|123|P|Tell your doctor if you have any of these conditions, including:||
8347|124|P|high blood pressure, high cholesterol, diabetes, family history||
8347|125|P|of heart disease, overweight, smoker, postmenopausal (women), age||
8347|126|P|more than 40 years (men).||
8347|127|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8347|128|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8347|129|P|machinery, or do anything that needs alertness until you can do||
8347|130|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
8347|131|P|are using marijuana (cannabis).||
8347|132|P|   Before having surgery, tell your doctor or dentist about all||
8347|133|P|the products you use (including prescription drugs,||
8347|134|P|nonprescription drugs, and herbal products).||
8347|135|P|   The risk of heart disease, liver disease, and high blood||
8347|136|P|pressure increases with age. Older adults may be more sensitive||
8347|137|P|to the side effects of this drug, especially increased blood||
8347|138|P|pressure and heart problems.||
8347|139|P|   During pregnancy, this medication should be used only when||
8347|140|P|clearly needed. Discuss the risks and benefits with your doctor.||
8347|141|P|   It is unknown if this drug passes into breast milk. Consult||
8347|142|P|your doctor before breastfeeding.||
8347|143|B|||
8347|144|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8347|145|I|medications work or increase your risk for serious side effects.||
8347|146|I|This document does not contain all possible drug interactions.||
8347|147|I|Keep a list of all the products you use (including||
8347|148|I|prescription/nonprescription drugs and herbal products) and share||
8347|149|I|it with your doctor and pharmacist. Do not start, stop, or change||
8347|150|I|the dosage of any medicines without your doctor's approval.||
8347|151|I|   Taking MAO inhibitors with this medication may cause a serious||
8347|152|I|(possibly fatal) drug interaction. Do not take any MAO inhibitors||
8347|153|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
8347|154|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
8347|155|I|selegiline, tranylcypromine) during treatment with this||
8347|156|I|medication. Most MAO inhibitors should also not be taken for two||
8347|157|I|weeks before treatment with this medication. Ask your doctor when||
8347|158|I|to start or stop taking this medication.||
8347|159|I|   The risk of serotonin syndrome/toxicity increases if you are||
8347|160|I|also taking other drugs that increase serotonin. Examples include||
8347|161|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
8347|162|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
8347|163|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
8347|164|I|serotonin syndrome/toxicity may be more likely when you start or||
8347|165|I|increase the dose of these drugs.||
8347|166|I|   If you also take any ergotamine medication (such as||
8347|167|I|dihydroergotamine) or other "triptan" drugs (such as sumatriptan,||
8347|168|I|rizatriptan), you will need to separate your zolmitriptan dose||
8347|169|I|from your dose of these other medications to lessen the chance of||
8347|170|I|serious side effects. Ask your doctor how long you should wait||
8347|171|I|between your doses of these drugs.||
8347|172|B|||
8347|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8347|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8347|175|O|poison control center right away. US residents can call||
8347|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8347|177|B|||
8347|178|N|NOTES:  Do not share this medication with others.||
8347|179|N|   Certain foods, beverages, or food additives (such as red wine,||
8347|180|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
8347|181|N|patterns such as irregular eating/sleeping habits or stress may||
8347|182|N|bring on a migraine headache. Avoiding these "triggers" may help||
8347|183|N|lessen migraine attacks. Consult your doctor for more details.||
8347|184|N|   Lab and/or medical tests (such as blood pressure) may be done||
8347|185|N|while you are using this medication. Keep all medical and lab||
8347|186|N|appointments. Consult your doctor for more details.||
8347|187|B|||
8347|188|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
8347|189|B|||
8347|190|R|STORAGE:  Store at room temperature. Each spray device contains||
8347|191|R|one dose. Discard medication after using. Keep all medications||
8347|192|R|away from children and pets.||
8347|193|R|   Do not flush medications down the toilet or pour them into a||
8347|194|R|drain unless instructed to do so. Properly discard this product||
8347|195|R|when it is expired or no longer needed. Consult your pharmacist||
8347|196|R|or local waste disposal company.||
8347|197|B|||
8347|198|A|Information last revised January 2025.||
8347|199|A|Copyright(c) 2025 First Databank, Inc.||
8347|200|B|||
8352|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8352|002|Z|does NOT have all possible information about this product. This||
8352|003|Z|information does not assure that this product is safe, effective,||
8352|004|Z|or appropriate for you. This information is not individual||
8352|005|Z|medical advice and does not substitute for the advice of your||
8352|006|Z|health care professional. Always ask your health care||
8352|007|Z|professional for complete information about this product and your||
8352|008|Z|specific health needs.||
8352|009|B|||
8352|010|T|BUPRENORPHINE/NALOXONE - SUBLINGUAL||
8352|011|F|(BUE-pre-NOR-feen/nal-OX-one)||
8352|012|B|||
8352|013|C|COMMON BRAND NAME(S): Suboxone, Zubsolv||
8352|014|B|||
8352|015|U|USES:  This medication contains 2 medicines: buprenorphine and||
8352|016|U|naloxone. It is used to treat opioid use disorder. Buprenorphine||
8352|017|U|belongs to a class of drugs called mixed opioid||
8352|018|U|agonist-antagonists. Buprenorphine helps prevent withdrawal||
8352|019|U|symptoms caused by stopping other opioids.||
8352|020|U|   Naloxone is an opioid antagonist that blocks the effect of||
8352|021|U|opioids and can cause severe opioid withdrawal when injected. It||
8352|022|U|has little effect when taken by mouth or dissolved under the||
8352|023|U|tongue. It is combined with buprenorphine to prevent abuse and||
8352|024|U|misuse (injection) of this medication. This combination||
8352|025|U|medication is used as part of a complete treatment program for||
8352|026|U|opioid use disorder (such as compliance monitoring, counseling,||
8352|027|U|behavioral contract, lifestyle changes).||
8352|028|U|   Ask your doctor or pharmacist if you should have medication||
8352|029|U|available to treat opioid overdose (such as nalmefene, other||
8352|030|U|forms of naloxone). Teach your family or household members about||
8352|031|U|the signs of an opioid overdose and how to treat it.||
8352|032|B|||
8352|033|H|HOW TO USE:  Read the Medication Guide provided by your||
8352|034|H|pharmacist before you start taking buprenorphine/naloxone and||
8352|035|H|each time you get a refill. If you have any questions, ask your||
8352|036|H|doctor or pharmacist.||
8352|037|H|   There are different brands and forms of this medication||
8352|038|H|available. Because different products may contain different||
8352|039|H|amounts of buprenorphine and naloxone, do not change brands or||
8352|040|H|dosage forms without consulting your doctor or pharmacist.||
8352|041|H|   Use this medication during your treatment maintenance period||
8352|042|H|as directed by your doctor, usually once daily. Place the||
8352|043|H|medication under your tongue for 5 to 10 minutes and let it||
8352|044|H|dissolve completely. If you are prescribed more than one tablet||
8352|045|H|each day, you may place all of the tablets under your tongue at||
8352|046|H|once or place two tablets at a time under your tongue. Do not||
8352|047|H|swallow or chew this medication. It will not work as well.||
8352|048|H|   After the medication is fully dissolved, take a large sip of||
8352|049|H|water and swish gently around your teeth and gums, and then||
8352|050|H|swallow the water. This will help to prevent problems with your||
8352|051|H|teeth. Do not brush your teeth for at least one hour after using||
8352|052|H|this medication.||
8352|053|H|   For most patients, buprenorphine alone is usually used for the||
8352|054|H|first 2 days after you have stopped all other opioids. It is||
8352|055|H|usually given in your doctor's office. Your doctor will then||
8352|056|H|switch you to this combination buprenorphine/naloxone medication||
8352|057|H|for maintenance treatment. The combination with naloxone works||
8352|058|H|the same way as buprenorphine alone to prevent withdrawal||
8352|059|H|symptoms. For some patients, this combination product may be used||
8352|060|H|to start treatment (called induction). Follow your doctor's||
8352|061|H|directions carefully.||
8352|062|H|   The dosage is based on your medical condition and response to||
8352|063|H|treatment. Do not increase your dose, take the medication more||
8352|064|H|often, or take it for a longer time than prescribed. Properly||
8352|065|H|stop the medication when so directed.||
8352|066|H|   Use this medication regularly in order to get the most benefit||
8352|067|H|from it. To help you remember, use it at the same time each day.||
8352|068|H|   Buprenorphine/naloxone may cause withdrawal symptoms||
8352|069|H|especially if you use it soon after using opioids such as heroin,||
8352|070|H|morphine, or methadone. Follow your doctor's instructions for||
8352|071|H|your treatment plan.||
8352|072|H|   If you suddenly stop using this medication, you may have||
8352|073|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
8352|074|H|nose, nausea, sweating, muscle aches). To help prevent||
8352|075|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
8352|076|H|more likely if you have used this medication for a long time or||
8352|077|H|in high doses. Tell your doctor or pharmacist right away if you||
8352|078|H|have withdrawal.||
8352|079|H|   Do not inject ("shoot up") buprenorphine/naloxone or inhale it||
8352|080|H|through the nose ("snort"). Doing so is dangerous, and will||
8352|081|H|likely cause severe withdrawal symptoms (see Side Effects||
8352|082|H|section) due to the naloxone in this medication, especially if||
8352|083|H|you have been using opioids such as heroin, morphine or||
8352|084|H|methadone. Consult your doctor or pharmacist for more details.||
8352|085|H|   Tell your doctor right away if you experience any withdrawal||
8352|086|H|reactions.||
8352|087|B|||
8352|088|S|SIDE EFFECTS:  Drowsiness, dizziness, constipation, or headache||
8352|089|S|may occur. If any of these effects last or get worse, tell your||
8352|090|S|doctor or pharmacist right away.||
8352|091|S|   To prevent constipation, eat dietary fiber, drink enough||
8352|092|S|water, and exercise. You may also need to take a laxative. Ask||
8352|093|S|your pharmacist which type of laxative is right for you.||
8352|094|S|   To reduce the risk of dizziness and lightheadedness, get up||
8352|095|S|slowly when rising from a sitting or lying position.||
8352|096|S|   Remember that this medication has been prescribed because your||
8352|097|S|doctor has judged that the benefit to you is greater than the||
8352|098|S|risk of side effects. Many people using this medication do not||
8352|099|S|have serious side effects.||
8352|100|S|   Severe (possibly fatal) breathing problems can occur if this||
8352|101|S|medication is abused, injected, or mixed with other depressants||
8352|102|S|(such as alcohol, benzodiazepines including diazepam, other||
8352|103|S|opioids).||
8352|104|S|   Tell your doctor right away if you have any serious side||
8352|105|S|effects, including: interrupted breathing during sleep (sleep||
8352|106|S|apnea), mental/mood changes (such as agitation, confusion,||
8352|107|S|hallucinations), stomach/abdominal pain, tooth/gum pain, signs of||
8352|108|S|your adrenal glands not working well (such as unusual tiredness,||
8352|109|S|weight loss), trouble swallowing.||
8352|110|S|   Although this medication is used to prevent withdrawal||
8352|111|S|reactions, it may rarely cause opioid withdrawal symptoms,||
8352|112|S|including diarrhea, severe mental/mood changes (such as anxiety,||
8352|113|S|irritability, trouble sleeping), muscle stiffness or shakiness.||
8352|114|S|This is more likely when you first start treatment or if you have||
8352|115|S|been using long-acting opioids such as methadone. If such||
8352|116|S|symptoms occur, notify your doctor or pharmacist right away.||
8352|117|S|   Get medical help right away if you have any very serious side||
8352|118|S|effects, including: fainting, fast/irregular heartbeat, severe||
8352|119|S|dizziness, slow/shallow breathing, unusual drowsiness/difficulty||
8352|120|S|waking up.||
8352|121|S|   This drug may rarely cause serious liver disease. Get medical||
8352|122|S|help right away if you have any symptoms of liver damage,||
8352|123|S|including: nausea/vomiting that doesn't stop, dark urine, loss of||
8352|124|S|appetite, yellowing eyes/skin, severe stomach/abdominal pain.||
8352|125|S|   A very serious allergic reaction to this drug is rare.||
8352|126|S|However, get medical help right away if you notice any symptoms||
8352|127|S|of a serious allergic reaction, including: rash, itching/swelling||
8352|128|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8352|129|S|breathing.||
8352|130|S|   This is not a complete list of possible side effects. If you||
8352|131|S|notice other effects not listed above, contact your doctor or||
8352|132|S|pharmacist.||
8352|133|S|   In the US -||
8352|134|S|   Call your doctor for medical advice about side effects. You||
8352|135|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8352|136|S|www.fda.gov/medwatch.||
8352|137|S|   In Canada - Call your doctor for medical advice about side||
8352|138|S|effects. You may report side effects to Health Canada at||
8352|139|S|1-866-234-2345.||
8352|140|B|||
8352|141|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
8352|142|P|pharmacist if you are allergic to buprenorphine or naloxone; or||
8352|143|P|if you have any other allergies. This product may contain||
8352|144|P|inactive ingredients, which can cause allergic reactions or other||
8352|145|P|problems. Talk to your pharmacist for more details.||
8352|146|P|   Before using this medication, tell your doctor or pharmacist||
8352|147|P|your medical history, especially of: brain disorders (such as||
8352|148|P|head injury, tumor, seizures), breathing problems (such as||
8352|149|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
8352|150|P|liver disease, mental/mood disorders (such as confusion,||
8352|151|P|depression), stomach/intestinal problems (such as blockage,||
8352|152|P|constipation, diarrhea due to infection, paralytic ileus),||
8352|153|P|difficulty urinating (such as due to enlarged prostate).||
8352|154|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
8352|155|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
8352|156|P|machinery, or do anything that needs alertness until you can do||
8352|157|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
8352|158|P|are using marijuana (cannabis). Alcohol also increases your risk||
8352|159|P|for breathing problems.||
8352|160|P|   Buprenorphine may cause a condition that affects the heart||
8352|161|P|rhythm (QT prolongation). QT prolongation can rarely cause||
8352|162|P|serious (rarely fatal) fast/irregular heartbeat and other||
8352|163|P|symptoms (such as severe dizziness, fainting) that need medical||
8352|164|P|attention right away.||
8352|165|P|   The risk of QT prolongation may be increased if you have||
8352|166|P|certain medical conditions or are taking other drugs that may||
8352|167|P|cause QT prolongation. Before using buprenorphine, tell your||
8352|168|P|doctor or pharmacist of all the drugs you take and if you have||
8352|169|P|any of the following conditions: certain heart problems (heart||
8352|170|P|failure, slow heartbeat, QT prolongation in the EKG), family||
8352|171|P|history of certain heart problems (QT prolongation in the EKG,||
8352|172|P|sudden cardiac death).||
8352|173|P|   Low levels of potassium or magnesium in the blood may also||
8352|174|P|increase your risk of QT prolongation. This risk may increase if||
8352|175|P|you use certain drugs (such as diuretics/"water pills") or if you||
8352|176|P|have conditions such as severe sweating, diarrhea, or vomiting.||
8352|177|P|Talk to your doctor about using buprenorphine safely.||
8352|178|P|   This medicine may contain aspartame. If you have||
8352|179|P|phenylketonuria (PKU) or any other condition that requires you to||
8352|180|P|restrict your intake of aspartame (or phenylalanine), consult||
8352|181|P|your doctor or pharmacist about using this drug safely.||
8352|182|P|   Some people using this medication may have dental problems||
8352|183|P|(such as tooth decay/loss, cavities, infection). Schedule a visit||
8352|184|P|to the dentist soon after starting this medication and tell your||
8352|185|P|dentist that you are using this medication. To help prevent||
8352|186|P|dental problems, have regular dental exams and learn how to keep||
8352|187|P|your teeth and gums healthy. If you have tooth or gum pain, tell||
8352|188|P|your doctor and dentist right away.||
8352|189|P|   Before having surgery, tell your doctor or dentist about all||
8352|190|P|the products you use (including prescription drugs,||
8352|191|P|nonprescription drugs, and herbal products).||
8352|192|P|   Older adults may be more sensitive to the side effects of this||
8352|193|P|drug, especially slow/shallow breathing, drowsiness, and QT||
8352|194|P|prolongation (see above).||
8352|195|P|   Before using this medication, women of childbearing age should||
8352|196|P|talk with their doctor(s) about the risks and benefits. Tell your||
8352|197|P|doctor if you are pregnant or if you plan to become pregnant.||
8352|198|P|During pregnancy, this medication should be used only when||
8352|199|P|clearly needed. It may slightly increase the risk of birth||
8352|200|P|defects if used during the first two months of pregnancy. Also,||
8352|201|P|using it for a long time or in high doses near the expected||
8352|202|P|delivery date may harm the unborn baby. To lessen the risk, use||
8352|203|P|the smallest effective dose for the shortest possible time. Tell||
8352|204|P|the doctor right away if you notice any symptoms in your newborn||
8352|205|P|baby such as slow/shallow breathing, irritability,||
8352|206|P|abnormal/nonstop crying, vomiting, or diarrhea.||
8352|207|P|   Buprenorphine passes into breast milk. It is unknown if||
8352|208|P|naloxone passes into breast milk. This product may rarely have||
8352|209|P|undesirable effects on a nursing infant. Tell the doctor right||
8352|210|P|away if your baby develops unusual sleepiness, difficulty||
8352|211|P|feeding, or trouble breathing. Consult your doctor before||
8352|212|P|breastfeeding.||
8352|213|B|||
8352|214|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8352|215|I|medications work or increase your risk for serious side effects.||
8352|216|I|This document does not contain all possible drug interactions.||
8352|217|I|Keep a list of all the products you use (including||
8352|218|I|prescription/nonprescription drugs and herbal products) and share||
8352|219|I|it with your doctor and pharmacist. Do not start, stop, or change||
8352|220|I|the dosage of any medicines without your doctor's approval.||
8352|221|I|   Some products that may interact with this medication include:||
8352|222|I|certain pain medications (mixed opioid agonist-antagonists such||
8352|223|I|as butorphanol, nalbuphine, pentazocine), naltrexone,||
8352|224|I|samidorphan.||
8352|225|I|   The risk of serious side effects (such as slow/shallow||
8352|226|I|breathing, severe drowsiness/dizziness) may be increased if this||
8352|227|I|medication is used with other products that may also affect||
8352|228|I|breathing or cause drowsiness. Tell your doctor or pharmacist if||
8352|229|I|you are taking other products such as alcohol, marijuana||
8352|230|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
8352|231|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
8352|232|I|zolpidem), muscle relaxants (such as carisoprodol,||
8352|233|I|cyclobenzaprine), and other opioid pain relievers (such as||
8352|234|I|codeine, hydrocodone).||
8352|235|I|   Check the labels on all your medicines (such as allergy or||
8352|236|I|cough-and-cold products) because they may contain ingredients||
8352|237|I|that cause drowsiness. Ask your pharmacist about using those||
8352|238|I|products safely.||
8352|239|I|   Deaths have occurred when this medication has been misused by||
8352|240|I|injecting it ("shooting up"), especially when used in combination||
8352|241|I|with benzodiazepines (such as diazepam) or other depressants such||
8352|242|I|as alcohol or additional opioids.||
8352|243|B|||
8352|244|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8352|245|O|as passing out or trouble breathing, give them naloxone if||
8352|246|O|available, then call 911. If the person is awake and has no||
8352|247|O|symptoms, call a poison control center right away. US residents||
8352|248|O|can call 1-800-222-1222. Canada residents can call||
8352|249|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
8352|250|O|breathing, slow heartbeat, coma.||
8352|251|B|||
8352|252|N|NOTES:  Do not share this medication with others. Sharing it is||
8352|253|N|against the law.||
8352|254|N|   Tell all of your doctors that you use this medication and have||
8352|255|N|regularly used opioids, especially in cases of emergency||
8352|256|N|treatment.||
8352|257|N|   Lab and/or medical tests (such as liver function) should be||
8352|258|N|done while you are taking this medication. Keep all medical and||
8352|259|N|lab appointments. Consult your doctor for more details.||
8352|260|B|||
8352|261|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8352|262|D|remember. If it is near the time of the next dose, skip the||
8352|263|D|missed dose. Take your next dose at the regular time. Do not||
8352|264|D|double the dose to catch up.||
8352|265|B|||
8352|266|R|STORAGE:  Store at room temperature away from light and moisture.||
8352|267|R|Do not store in the bathroom. Keep all medications away from||
8352|268|R|children and pets.||
8352|269|R|   Do not flush medications down the toilet or pour them into a||
8352|270|R|drain unless instructed to do so. Properly discard this product||
8352|271|R|when it is expired or no longer needed. For more details, read||
8352|272|R|the Medication Guide, or consult your pharmacist or local waste||
8352|273|R|disposal company.||
8352|274|B|||
8352|275|A|Information last revised August 2025.||
8352|276|A|Copyright(c) 2025 First Databank, Inc.||
8352|277|B|||
8353|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8353|002|Z|does NOT have all possible information about this product. This||
8353|003|Z|information does not assure that this product is safe, effective,||
8353|004|Z|or appropriate for you. This information is not individual||
8353|005|Z|medical advice and does not substitute for the advice of your||
8353|006|Z|health care professional. Always ask your health care||
8353|007|Z|professional for complete information about this product and your||
8353|008|Z|specific health needs.||
8353|009|B|||
8353|010|T|PROPRANOLOL EXTENDED-RELEASE - ORAL||
8353|011|F|(pro-PRAN-oh-lol)||
8353|012|B|||
8353|013|C|COMMON BRAND NAME(S): Inderal XL, Innopran XL||
8353|014|B|||
8353|015|W|WARNING:  Do not stop using this drug without first consulting||
8353|016|W|your doctor. Your condition may become worse when the drug is||
8353|017|W|suddenly stopped, especially if you have chest pain (angina) or||
8353|018|W|heart disease (such as coronary artery disease, ischemic heart||
8353|019|W|disease, high blood pressure). If your doctor decides you should||
8353|020|W|no longer use this drug, you must gradually decrease your dose||
8353|021|W|according to your doctor's instructions.||
8353|022|W|   When gradually stopping this medication, it is recommended||
8353|023|W|that you temporarily limit physical activity to decrease strain||
8353|024|W|on the heart. Get medical help right away if you develop:||
8353|025|W|worsening chest pain, tightness/pressure in the chest, chest pain||
8353|026|W|spreading to the jaw/neck/arm, unusual sweating, trouble||
8353|027|W|breathing, or fast/irregular heartbeat.||
8353|028|B|||
8353|029|U|USES:  This medication is a beta blocker used to treat high blood||
8353|030|U|pressure. Lowering high blood pressure helps prevent strokes,||
8353|031|U|heart attacks and kidney problems.||
8353|032|U|   This drug works by blocking the action of certain natural||
8353|033|U|chemicals in your body (such as epinephrine) that affect the||
8353|034|U|heart and blood vessels. This results in a lowering of heart||
8353|035|U|rate, blood pressure, and strain on the heart.||
8353|036|B|||
8353|037|V|OTHER USES:  This section contains uses of this drug that are not||
8353|038|V|listed in the approved professional labeling for the drug but||
8353|039|V|that may be prescribed by your health care professional. Use this||
8353|040|V|drug for a condition that is listed in this section only if it||
8353|041|V|has been so prescribed by your health care professional.||
8353|042|V|   Propranolol has also been used for irregular heartbeats,||
8353|043|V|shaking (tremors), and to control symptoms of anxiety or||
8353|044|V|overactive thyroid (hyperthyroidism). It has been used after a||
8353|045|V|heart attack to improve survival.||
8353|046|V|   This drug may also be used to reduce the risk of chest pain||
8353|047|V|(angina) or migraine headaches. It should not be used to treat||
8353|048|V|chest pain or migraines when they occur. Use other medications||
8353|049|V|(such as nitroglycerin tablets placed under the tongue for chest||
8353|050|V|pain, sumatriptan for migraines) to relieve sudden attacks as||
8353|051|V|directed by your doctor. Consult your doctor or pharmacist for||
8353|052|V|details.||
8353|053|B|||
8353|054|H|HOW TO USE:  See also Warning section.||
8353|055|H|   Take this medication by mouth as directed by your doctor,||
8353|056|H|usually once daily at bedtime. Swallow the capsules whole. Do not||
8353|057|H|crush or chew the capsules. You may take this medication with or||
8353|058|H|without food, but it is important to choose one way and take this||
8353|059|H|medication the same way with every dose.||
8353|060|H|   The dosage is based on your medical condition and response to||
8353|061|H|treatment.||
8353|062|H|   Use this medication regularly to get the most benefit from it.||
8353|063|H|To help you remember, take it at the same time each day. Keep||
8353|064|H|taking this medication even if you feel well. Most people with||
8353|065|H|high blood pressure do not feel sick.||
8353|066|H|   It may take 1 to 2 weeks before you get the full benefit of||
8353|067|H|this drug.||
8353|068|H|   If you also take certain drugs to lower your cholesterol (bile||
8353|069|H|acid-binding resins such as cholestyramine or colestipol), take||
8353|070|H|propranolol at least 1 hour before or at least 4 hours after||
8353|071|H|these medications.||
8353|072|H|   Tell your doctor if your condition does not get better or if||
8353|073|H|it gets worse (your blood pressure readings remain high or||
8353|074|H|increase).||
8353|075|B|||
8353|076|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
8353|077|S|   Dizziness, lightheadedness, or tiredness may occur as your||
8353|078|S|body adjusts to the medication. Nausea/vomiting, stomach pain,||
8353|079|S|vision changes, trouble sleeping, and unusual dreams may also||
8353|080|S|occur. If any of these effects last or get worse, tell your||
8353|081|S|doctor or pharmacist promptly.||
8353|082|S|   To reduce the risk of dizziness and lightheadedness, get up||
8353|083|S|slowly when rising from a sitting or lying position.||
8353|084|S|   This drug may reduce blood flow to your hands and feet,||
8353|085|S|causing them to feel cold. Smoking may worsen this effect. Dress||
8353|086|S|warmly and avoid tobacco use.||
8353|087|S|   Remember that this medication has been prescribed because your||
8353|088|S|doctor has judged that the benefit to you is greater than the||
8353|089|S|risk of side effects. Many people using this medication do not||
8353|090|S|have serious side effects.||
8353|091|S|   Tell your doctor right away if you have any serious side||
8353|092|S|effects, including: blue fingers/toes, mental/mood changes (such||
8353|093|S|as depression), numbness/tingling of arms/legs, new or worsening||
8353|094|S|symptoms of heart failure (such as shortness of breath, swelling||
8353|095|S|ankles/feet, unusual tiredness, unusual/sudden weight gain), very||
8353|096|S|slow heartbeat, fainting, decreased sexual ability, increased||
8353|097|S|thirst/urination, easy bruising/bleeding, signs of infection||
8353|098|S|(such as sore throat that doesn't go away, fever, chills),||
8353|099|S|aching/swollen joints.||
8353|100|S|   A very serious allergic reaction to this drug is rare.||
8353|101|S|However, get medical help right away if you notice any symptoms||
8353|102|S|of a serious allergic reaction, including: rash, itching/swelling||
8353|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8353|104|S|breathing.||
8353|105|S|   This is not a complete list of possible side effects. If you||
8353|106|S|notice other effects not listed above, contact your doctor or||
8353|107|S|pharmacist.||
8353|108|S|   In the US -||
8353|109|S|   Call your doctor for medical advice about side effects. You||
8353|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8353|111|S|www.fda.gov/medwatch.||
8353|112|S|   In Canada - Call your doctor for medical advice about side||
8353|113|S|effects. You may report side effects to Health Canada at||
8353|114|S|1-866-234-2345.||
8353|115|B|||
8353|116|P|PRECAUTIONS:  Before taking propranolol, tell your doctor or||
8353|117|P|pharmacist if you are allergic to it; or if you have had a||
8353|118|P|serious reaction to other beta blockers (such as metoprolol); or||
8353|119|P|if you have any other allergies. This product may contain||
8353|120|P|inactive ingredients, which can cause allergic reactions or other||
8353|121|P|problems. Talk to your pharmacist for more details.||
8353|122|P|   Before using this medication, tell your doctor or pharmacist||
8353|123|P|your medical history, especially of: breathing problems (such as||
8353|124|P|asthma, bronchitis, emphysema), heart failure, certain types of||
8353|125|P|heart rhythm problems (sinus bradycardia, Wolff-Parkinson-White||
8353|126|P|syndrome, second- or third-degree atrioventricular block),||
8353|127|P|overactive thyroid (hyperthyroidism), kidney disease, liver||
8353|128|P|disease, blood circulation problems (such as Raynaud's disease),||
8353|129|P|a certain adrenal gland tumor (pheochromocytoma), mental/mood||
8353|130|P|disorders (such as depression), certain muscle/nerve disease||
8353|131|P|(myasthenia gravis), severe allergic reactions.||
8353|132|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8353|133|P|can make you more dizzy. Do not drive, use machinery, or do||
8353|134|P|anything that needs alertness until you can do it safely. Limit||
8353|135|P|alcoholic beverages. Talk to your doctor if you are using||
8353|136|P|marijuana (cannabis).||
8353|137|P|   Before having surgery, tell your doctor or dentist about all||
8353|138|P|the products you use (including prescription drugs,||
8353|139|P|nonprescription drugs, and herbal products).||
8353|140|P|   This product may prevent the fast/pounding heartbeat you would||
8353|141|P|usually feel when your blood sugar level falls too low||
8353|142|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
8353|143|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
8353|144|P|blood sugar level, such as dizziness and sweating, are not||
8353|145|P|affected by this drug.||
8353|146|P|   If you have diabetes, this product may make it harder to||
8353|147|P|control your blood sugar levels. Check your blood sugar levels||
8353|148|P|regularly as directed by your doctor. Tell your doctor right away||
8353|149|P|if you have symptoms of high blood sugar such as increased||
8353|150|P|thirst/urination. Your doctor may need to adjust your diabetes||
8353|151|P|medication, exercise program, or diet.||
8353|152|P|   Children may be at greater risk for low blood sugar||
8353|153|P|(hypoglycemia) while using this drug, especially if they are||
8353|154|P|vomiting or not eating regularly. To help prevent low blood||
8353|155|P|sugar, make sure children eat regularly. If your child cannot eat||
8353|156|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
8353|157|P|as sweating, shaking), tell the doctor right away.||
8353|158|P|   During pregnancy, this medication should be used only when||
8353|159|P|clearly needed. Infants exposed to this medication during||
8353|160|P|pregnancy may have low birth weight, low blood sugar, or slow||
8353|161|P|breathing/heartbeat. Discuss the risks and benefits with your||
8353|162|P|doctor.||
8353|163|P|   This drug passes into breast milk. Consult your doctor before||
8353|164|P|breastfeeding.||
8353|165|B|||
8353|166|I|DRUG INTERACTIONS:  See also How to Use section.||
8353|167|I|   Drug interactions may change how your medications work or||
8353|168|I|increase your risk for serious side effects. This document does||
8353|169|I|not contain all possible drug interactions. Keep a list of all||
8353|170|I|the products you use (including prescription/nonprescription||
8353|171|I|drugs and herbal products) and share it with your doctor and||
8353|172|I|pharmacist. Do not start, stop, or change the dosage of any||
8353|173|I|medicines without your doctor's approval.||
8353|174|I|   Some products that may interact with this drug are:||
8353|175|I|epinephrine, fingolimod.||
8353|176|I|   Other medications can affect the removal of propranolol from||
8353|177|I|your body, which may affect how propranolol works. Examples||
8353|178|I|include quinidine, rifamycins (such as rifabutin), among others.||
8353|179|I|   This medication can slow down the removal of other medications||
8353|180|I|from your body, which may affect how they work. Examples of||
8353|181|I|affected drugs include fezolinetant, propafenone, thioridazine,||
8353|182|I|among others.||
8353|183|I|   Some products have ingredients that could raise your heart||
8353|184|I|rate or blood pressure. Tell your pharmacist what products you||
8353|185|I|are using, and ask how to use them safely (especially||
8353|186|I|cough-and-cold products, diet aids, or NSAIDs such as||
8353|187|I|ibuprofen/naproxen).||
8353|188|I|   This medication may interfere with certain lab tests (such as||
8353|189|I|glaucoma screening test), possibly causing false test results.||
8353|190|I|Make sure lab personnel and all your doctors know you use this||
8353|191|I|drug.||
8353|192|B|||
8353|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8353|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8353|195|O|poison control center right away. US residents can call||
8353|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8353|197|O|Symptoms of overdose may include unusually slow heartbeat, severe||
8353|198|O|dizziness, slow or shallow breathing, weakness, or fainting.||
8353|199|B|||
8353|200|N|NOTES:  Do not share this medication with others. Lifestyle||
8353|201|N|changes such as stress reduction programs, exercise and dietary||
8353|202|N|changes may increase the effectiveness of this medicine. Talk to||
8353|203|N|your doctor or pharmacist about lifestyle changes that might||
8353|204|N|benefit you.||
8353|205|N|   Have your blood pressure and pulse checked regularly while||
8353|206|N|taking this medication. It may be best to learn how to monitor||
8353|207|N|your own blood pressure and pulse. Discuss this with your doctor.||
8353|208|B|||
8353|209|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8353|210|D|remember. If it is within 8 hours of the next dose, skip the||
8353|211|D|missed dose. Take your next dose at the regular time. Do not||
8353|212|D|double the dose to catch up.||
8353|213|B|||
8353|214|R|STORAGE:  Store at room temperature away from light and moisture.||
8353|215|R|Do not store in the bathroom. Keep all medications away from||
8353|216|R|children and pets.||
8353|217|R|   Do not flush medications down the toilet or pour them into a||
8353|218|R|drain unless instructed to do so. Properly discard this product||
8353|219|R|when it is expired or no longer needed. Consult your pharmacist||
8353|220|R|or local waste disposal company.||
8353|221|B|||
8353|222|M|MEDICAL ALERT:  Your condition can cause complications in a||
8353|223|M|medical emergency. For information about enrolling in MedicAlert,||
8353|224|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8353|225|B|||
8353|226|A|Information last revised May 2025.||
8353|227|A|Copyright(c) 2025 First Databank, Inc.||
8353|228|B|||
8367|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8367|002|Z|does NOT have all possible information about this product. This||
8367|003|Z|information does not assure that this product is safe, effective,||
8367|004|Z|or appropriate for you. This information is not individual||
8367|005|Z|medical advice and does not substitute for the advice of your||
8367|006|Z|health care professional. Always ask your health care||
8367|007|Z|professional for complete information about this product and your||
8367|008|Z|specific health needs.||
8367|009|B|||
8367|010|T|CLORAZEPATE - ORAL||
8367|011|F|(klor-AZ-e-pate)||
8367|012|B|||
8367|013|C|COMMON BRAND NAME(S): Tranxene||
8367|014|B|||
8367|015|W|WARNING:  Clorazepate has a risk for abuse and addiction, which||
8367|016|W|can lead to overdose and death. Taking this medication with||
8367|017|W|alcohol or other drugs that can cause drowsiness or breathing||
8367|018|W|problems (especially opioid medications such as codeine,||
8367|019|W|hydrocodone) may cause very serious side effects, including||
8367|020|W|death. To lower your risk, your doctor should have you take the||
8367|021|W|smallest dose of clorazepate that works, and take it for the||
8367|022|W|shortest possible time. Be sure you know how to take clorazepate||
8367|023|W|and what other drugs you should avoid taking with it. See also||
8367|024|W|Drug Interactions section. Get medical help right away if any of||
8367|025|W|these very serious side effects occur: slow/shallow breathing,||
8367|026|W|unusual lightheadedness, severe drowsiness/dizziness, difficulty||
8367|027|W|waking up.||
8367|028|W|   Suddenly stopping this medication may cause serious (possibly||
8367|029|W|fatal) withdrawal, especially if you have used it for a long time||
8367|030|W|or in high doses. To prevent withdrawal, your doctor may lower||
8367|031|W|your dose slowly. Tell your doctor or pharmacist right away if||
8367|032|W|you have any withdrawal symptoms such as headaches, trouble||
8367|033|W|sleeping, restlessness, hallucinations/confusion, depression,||
8367|034|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
8367|035|W|to months.||
8367|036|B|||
8367|037|U|USES:  Clorazepate is used to treat anxiety, acute alcohol||
8367|038|U|withdrawal, and seizures. This medication belongs to a class of||
8367|039|U|drugs called benzodiazepines which act on the brain and nerves||
8367|040|U|(central nervous system) to produce a calming effect. It works by||
8367|041|U|enhancing the effects of a certain natural chemical in the body||
8367|042|U|(GABA).||
8367|043|B|||
8367|044|H|HOW TO USE:  See also Warning section.||
8367|045|H|   Read the Medication Guide provided by your pharmacist before||
8367|046|H|you start taking clorazepate and each time you get a refill. If||
8367|047|H|you have any questions, ask your doctor or pharmacist.||
8367|048|H|   Take this medication by mouth as directed by your doctor. The||
8367|049|H|dosage is based on your age, medical condition, and response to||
8367|050|H|treatment.||
8367|051|H|   When this medication is used for a long time, it may not work||
8367|052|H|as well. Talk with your doctor if this medication stops working||
8367|053|H|well.||
8367|054|H|   Though it helps many people, this medication may sometimes||
8367|055|H|cause addiction. This risk may be higher if you have a substance||
8367|056|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
8367|057|H|Take this medication exactly as prescribed to lower the risk of||
8367|058|H|addiction. Ask your doctor or pharmacist for more details.||
8367|059|H|   Tell your doctor if your condition lasts or gets worse.||
8367|060|B|||
8367|061|S|SIDE EFFECTS:  See also Warning section.||
8367|062|S|   Drowsiness, dizziness, tiredness, dry mouth, upset stomach,||
8367|063|S|constipation, blurred vision, or headache may occur. If any of||
8367|064|S|these effects last or get worse, tell your doctor or pharmacist||
8367|065|S|promptly.||
8367|066|S|   Remember that this medication has been prescribed because your||
8367|067|S|doctor has judged that the benefit to you is greater than the||
8367|068|S|risk of side effects. Many people using this medication do not||
8367|069|S|have serious side effects.||
8367|070|S|   Tell your doctor right away if you have any serious side||
8367|071|S|effects, including: trouble speaking, clumsiness, trouble||
8367|072|S|walking, decreased/increased interest in sex, tremor, trouble||
8367|073|S|urinating, sleep disturbances, signs of liver disease (such as||
8367|074|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
8367|075|S|yellowing eyes/skin, dark urine), sore throat or fever that||
8367|076|S|doesn't go away.||
8367|077|S|   A small number of people who take anticonvulsants for any||
8367|078|S|condition (such as seizure, bipolar disorder, pain) may||
8367|079|S|experience depression, suicidal thoughts/attempts, or other||
8367|080|S|mental/mood problems. Tell your doctor right away if you or your||
8367|081|S|family/caregiver notice any unusual/sudden changes in your mood,||
8367|082|S|thoughts, or behavior including signs of depression, suicidal||
8367|083|S|thoughts/attempts, thoughts about harming yourself.||
8367|084|S|   A very serious allergic reaction to this drug is rare.||
8367|085|S|However, get medical help right away if you notice any symptoms||
8367|086|S|of a serious allergic reaction, including: rash, itching/swelling||
8367|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8367|088|S|breathing.||
8367|089|S|   This is not a complete list of possible side effects. If you||
8367|090|S|notice other effects not listed above, contact your doctor or||
8367|091|S|pharmacist.||
8367|092|S|   In the US -||
8367|093|S|   Call your doctor for medical advice about side effects. You||
8367|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8367|095|S|www.fda.gov/medwatch.||
8367|096|S|   In Canada - Call your doctor for medical advice about side||
8367|097|S|effects. You may report side effects to Health Canada at||
8367|098|S|1-866-234-2345.||
8367|099|B|||
8367|100|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
8367|101|P|pharmacist if you are allergic to it; or to other benzodiazepines||
8367|102|P|(such as diazepam, lorazepam); or if you have any other||
8367|103|P|allergies. This product may contain inactive ingredients, which||
8367|104|P|can cause allergic reactions or other problems. Talk to your||
8367|105|P|pharmacist for more details.||
8367|106|P|   Before using this medication, tell your doctor or pharmacist||
8367|107|P|your medical history, especially of: liver disease, kidney||
8367|108|P|disease, lung/breathing problems (such as COPD, sleep apnea),||
8367|109|P|drug or alcohol abuse.||
8367|110|P|   This drug may make you dizzy or drowsy or blur your vision.||
8367|111|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
8367|112|P|drowsy. Do not drive, use machinery, or do anything that needs||
8367|113|P|alertness or clear vision until you can do it safely. Avoid||
8367|114|P|alcoholic beverages. Talk to your doctor if you are using||
8367|115|P|marijuana (cannabis).||
8367|116|P|   Before having surgery, tell your doctor or dentist about all||
8367|117|P|the products you use (including prescription drugs,||
8367|118|P|nonprescription drugs, and herbal products).||
8367|119|P|   Older adults may be more sensitive to the side effects of this||
8367|120|P|drug, especially drowsiness, which can increase the risk of||
8367|121|P|falling.||
8367|122|P|   During pregnancy, this medication should be used only when||
8367|123|P|clearly needed. It may harm an unborn baby. Newborn babies of||
8367|124|P|mothers who use this medication late in pregnancy may have||
8367|125|P|symptoms such as slow/shallow breathing, nonstop crying, shaking,||
8367|126|P|or trouble feeding. However, since untreated seizures are a||
8367|127|P|serious condition that can harm both a pregnant woman and her||
8367|128|P|unborn baby, do not stop using this medication unless directed by||
8367|129|P|your doctor. If you are planning pregnancy, become pregnant, or||
8367|130|P|think you may be pregnant, talk to your doctor right away about||
8367|131|P|the risks and benefits of this medication.||
8367|132|P|   This drug passes into breast milk and may have undesirable||
8367|133|P|effects on a nursing infant. Consult your doctor before||
8367|134|P|breastfeeding.||
8367|135|B|||
8367|136|I|DRUG INTERACTIONS:  See also Warning section.||
8367|137|I|   Drug interactions may change how your medications work or||
8367|138|I|increase your risk for serious side effects. This document does||
8367|139|I|not contain all possible drug interactions. Keep a list of all||
8367|140|I|the products you use (including prescription/nonprescription||
8367|141|I|drugs and herbal products) and share it with your doctor and||
8367|142|I|pharmacist. Do not start, stop, or change the dosage of any||
8367|143|I|medicines without your doctor's approval.||
8367|144|I|   Some products that may interact with this drug include:||
8367|145|I|antacids, certain anti-depressants (such as fluoxetine,||
8367|146|I|fluvoxamine, nefazodone), cimetidine, clozapine, digoxin,||
8367|147|I|disulfiram, kava, orlistat, sodium oxybate.||
8367|148|I|   The risk of serious side effects (such as slow/shallow||
8367|149|I|breathing, severe drowsiness/dizziness) may be increased if this||
8367|150|I|medication is taken with other products that may also cause||
8367|151|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
8367|152|I|if you are taking other products such as opioid pain or cough||
8367|153|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
8367|154|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
8367|155|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
8367|156|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
8367|157|I|diphenhydramine).||
8367|158|I|   Check the labels on all your medicines (such as allergy or||
8367|159|I|cough-and-cold products) because they may contain ingredients||
8367|160|I|that cause drowsiness. Ask your pharmacist about using those||
8367|161|I|products safely.||
8367|162|I|   Cigarette smoking decreases blood levels of this medication.||
8367|163|I|Tell your doctor if you smoke or if you have recently stopped||
8367|164|I|smoking.||
8367|165|B|||
8367|166|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8367|167|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8367|168|O|poison control center right away. US residents can call||
8367|169|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8367|170|O|Symptoms of overdose may include: severe drowsiness,||
8367|171|O|slowed/reduced reflexes, slowed breathing, loss of consciousness.||
8367|172|B|||
8367|173|N|NOTES:  Do not share this medication with others. Sharing it is||
8367|174|N|against the law.||
8367|175|N|   If this drug is used for an extended period of time, lab||
8367|176|N|and/or medical tests (such as liver function, complete blood||
8367|177|N|count) may be done while you are taking this medication. Keep all||
8367|178|N|medical and lab appointments. Consult your doctor for more||
8367|179|N|details.||
8367|180|B|||
8367|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8367|182|D|remember. If it is near the time of the next dose, skip the||
8367|183|D|missed dose. Take your next dose at the regular time. Do not||
8367|184|D|double the dose to catch up.||
8367|185|B|||
8367|186|R|STORAGE:  Store at room temperature away from light and moisture.||
8367|187|R|Do not store in the bathroom. Keep all medications away from||
8367|188|R|children and pets.||
8367|189|R|   Do not flush medications down the toilet or pour them into a||
8367|190|R|drain unless instructed to do so. Properly discard this product||
8367|191|R|when it is expired or no longer needed. Consult your pharmacist||
8367|192|R|or local waste disposal company.||
8367|193|B|||
8367|194|M|MEDICAL ALERT:  Your condition can cause complications in a||
8367|195|M|medical emergency. For information about enrolling in MedicAlert,||
8367|196|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
8367|197|B|||
8367|198|A|Information last revised May 2024.||
8367|199|A|Copyright(c) 2025 First Databank, Inc.||
8367|200|B|||
8368|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8368|002|Z|does NOT have all possible information about this product. This||
8368|003|Z|information does not assure that this product is safe, effective,||
8368|004|Z|or appropriate for you. This information is not individual||
8368|005|Z|medical advice and does not substitute for the advice of your||
8368|006|Z|health care professional. Always ask your health care||
8368|007|Z|professional for complete information about this product and your||
8368|008|Z|specific health needs.||
8368|009|B|||
8368|010|T|KETOROLAC 0.4% SOLUTION - OPHTHALMIC||
8368|011|F|(KEE-toe-ROLE-ak)||
8368|012|B|||
8368|013|C|COMMON BRAND NAME(S): Acular LS||
8368|014|B|||
8368|015|U|USES:  This medication is used to relieve eye pain, burning, and||
8368|016|U|stinging following a certain type of corrective eye surgery||
8368|017|U|(corneal refractive surgery). Ketorolac belongs to a class of||
8368|018|U|drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It||
8368|019|U|works by blocking certain natural substances in your body to||
8368|020|U|reduce pain and swelling.||
8368|021|B|||
8368|022|H|HOW TO USE:  Use this medication in the affected eye(s) as||
8368|023|H|directed by your doctor, usually 4 times daily as needed.||
8368|024|H|   To apply eye drops, wash your hands first. To avoid||
8368|025|H|contamination, do not touch the dropper tip or let it touch your||
8368|026|H|eye or any other surface.||
8368|027|H|   This medication should not be used while wearing contact||
8368|028|H|lenses. Consult your doctor or pharmacist for details.||
8368|029|H|   Tilt your head back, look upward, and pull down the lower||
8368|030|H|eyelid to make a pouch. Hold the dropper directly over your eye||
8368|031|H|and place one drop into the pouch. Look downward and gently close||
8368|032|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
8368|033|H|your eye (near the nose) and apply gentle pressure. This will||
8368|034|H|prevent the medication from draining out. Try not to blink and do||
8368|035|H|not rub your eye. Repeat these steps for your other eye if so||
8368|036|H|directed.||
8368|037|H|   Do not rinse the dropper. Replace the dropper cap after each||
8368|038|H|use.||
8368|039|H|   If you are using another kind of eye medication (such as drops||
8368|040|H|or ointments), wait at least 5 minutes before applying other||
8368|041|H|medications. Use eye drops before eye ointments to allow the eye||
8368|042|H|drops to enter the eye.||
8368|043|H|   Wait several minutes for your vision to clear before driving||
8368|044|H|or operating machinery.||
8368|045|H|   This medication is usually used for up to 4 days after eye||
8368|046|H|surgery or as directed by your doctor. Do not apply this||
8368|047|H|medication more often than prescribed or keep using it for longer||
8368|048|H|than directed by your doctor. Prolonged use of ketorolac eye||
8368|049|H|drops (more than 2 weeks) may increase the risk of very serious||
8368|050|H|side effects of the eye.||
8368|051|H|   Tell your doctor if your condition lasts or gets worse.||
8368|052|B|||
8368|053|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
8368|054|S|eyes for 1-2 minutes when applied. Eye redness and headache may||
8368|055|S|also occur. If any of these effects last or get worse, tell your||
8368|056|S|doctor or pharmacist promptly.||
8368|057|S|   Remember that this medication has been prescribed because your||
8368|058|S|doctor has judged that the benefit to you is greater than the||
8368|059|S|risk of side effects. Many people using this medication do not||
8368|060|S|have serious side effects.||
8368|061|S|   Tell your doctor right away if you have any serious side||
8368|062|S|effects, including: eye pain/swelling/discharge, vision changes,||
8368|063|S|bleeding inside the eye.||
8368|064|S|   A very serious allergic reaction to this drug is rare.||
8368|065|S|However, get medical help right away if you notice any symptoms||
8368|066|S|of a serious allergic reaction, including: rash, itching/swelling||
8368|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8368|068|S|breathing.||
8368|069|S|   This is not a complete list of possible side effects. If you||
8368|070|S|notice other effects not listed above, contact your doctor or||
8368|071|S|pharmacist.||
8368|072|S|   In the US -||
8368|073|S|   Call your doctor for medical advice about side effects. You||
8368|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8368|075|S|www.fda.gov/medwatch.||
8368|076|S|   In Canada - Call your doctor for medical advice about side||
8368|077|S|effects. You may report side effects to Health Canada at||
8368|078|S|1-866-234-2345.||
8368|079|B|||
8368|080|P|PRECAUTIONS:  Before using ketorolac, tell your doctor or||
8368|081|P|pharmacist if you are allergic to it; or to aspirin, other NSAIDs||
8368|082|P|(such as ibuprofen, celecoxib); or if you have any other||
8368|083|P|allergies. This product may contain inactive ingredients (such as||
8368|084|P|preservatives like benzalkonium chloride), which can cause||
8368|085|P|allergic reactions or other problems. Talk to your pharmacist for||
8368|086|P|more details.||
8368|087|P|   Before using this medication, tell your doctor or pharmacist||
8368|088|P|your medical history, especially of: asthma (including a history||
8368|089|P|of worsening breathing after taking aspirin or other NSAIDs),||
8368|090|P|bleeding problems, previous eye surgery, other eye problems (such||
8368|091|P|as dry eye syndrome, corneal problems), diabetes, rheumatoid||
8368|092|P|arthritis, nasal polyps.||
8368|093|P|   After you apply this drug, your vision may become temporarily||
8368|094|P|blurred or unstable. Do not drive, use machinery, or do anything||
8368|095|P|that needs clear vision until you can do it safely.||
8368|096|P|   During pregnancy, this medication should be used only when||
8368|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
8368|098|P|   It is unknown if this drug passes into breast milk, but it is||
8368|099|P|unlikely to harm a nursing infant. Consult your doctor before||
8368|100|P|breastfeeding.||
8368|101|B|||
8368|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8368|103|I|medications work or increase your risk for serious side effects.||
8368|104|I|This document does not contain all possible drug interactions.||
8368|105|I|Keep a list of all the products you use (including||
8368|106|I|prescription/nonprescription drugs and herbal products) and share||
8368|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
8368|108|I|the dosage of any medicines without your doctor's approval.||
8368|109|I|   Some products that may interact with this drug are:||
8368|110|I|corticosteroid drugs (such as prednisone), other eye medications||
8368|111|I|(such as corticosteroid eye drops).||
8368|112|I|   This medication may increase the risk of bleeding when used||
8368|113|I|with other drugs that also may cause bleeding. Examples include||
8368|114|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
8368|115|I|dabigatran/enoxaparin/warfarin, among others.||
8368|116|I|   Check all prescription and nonprescription medicine labels||
8368|117|I|carefully since many medications contain pain relievers/fever||
8368|118|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These||
8368|119|I|drugs are similar to ketorolac and may increase your risk of side||
8368|120|I|effects if taken together. However, if your doctor has told you||
8368|121|I|to take low-dose aspirin to prevent heart attack or stroke||
8368|122|I|(usually 81-162 milligrams a day), you should keep taking the||
8368|123|I|aspirin unless your doctor tells you not to. Ask your doctor or||
8368|124|I|pharmacist for more details.||
8368|125|B|||
8368|126|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8368|127|O|has overdosed and has serious symptoms such as passing out or||
8368|128|O|trouble breathing, call 911. Otherwise, call a poison control||
8368|129|O|center right away. US residents can call 1-800-222-1222. Canada||
8368|130|O|residents can call 1-844-764-7669.||
8368|131|B|||
8368|132|N|NOTES:  Do not share this medication with others.||
8368|133|N|   This medication has been prescribed for your current condition||
8368|134|N|only. Do not use it later for another eye condition unless told||
8368|135|N|to do so by your doctor. A different medication may be necessary||
8368|136|N|in those cases.||
8368|137|B|||
8368|138|D|MISSED DOSE:  If you have been instructed to use this drug on a||
8368|139|D|regular schedule, use the missed dose as soon as you remember. If||
8368|140|D|it is near the time of the next dose, skip the missed dose. Use||
8368|141|D|your next dose at the regular time. Do not double the dose to||
8368|142|D|catch up.||
8368|143|B|||
8368|144|R|STORAGE:  Different brands of this medication have different||
8368|145|R|storage needs. Check the product package for instructions on how||
8368|146|R|to store your brand, or ask your pharmacist. Keep all medications||
8368|147|R|away from children and pets.||
8368|148|R|   Do not flush medications down the toilet or pour them into a||
8368|149|R|drain unless instructed to do so. Properly discard this product||
8368|150|R|when it is expired or no longer needed. Consult your pharmacist||
8368|151|R|or local waste disposal company.||
8368|152|B|||
8368|153|A|Information last revised November 2024.||
8368|154|A|Copyright(c) 2025 First Databank, Inc.||
8368|155|B|||
8372|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8372|002|Z|does NOT have all possible information about this product. This||
8372|003|Z|information does not assure that this product is safe, effective,||
8372|004|Z|or appropriate for you. This information is not individual||
8372|005|Z|medical advice and does not substitute for the advice of your||
8372|006|Z|health care professional. Always ask your health care||
8372|007|Z|professional for complete information about this product and your||
8372|008|Z|specific health needs.||
8372|009|B|||
8372|010|T|LOSARTAN - ORAL||
8372|011|F|(low-SAR-tan)||
8372|012|B|||
8372|013|C|COMMON BRAND NAME(S):  Cozaar, Arbli||
8372|014|B|||
8372|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
8372|016|W|unborn baby if used during pregnancy. It is important to prevent||
8372|017|W|pregnancy while taking this medication. Consult your doctor for||
8372|018|W|more details and to discuss the use of reliable forms of birth||
8372|019|W|control while taking this medication. If you are planning||
8372|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
8372|021|W|your doctor right away.||
8372|022|B|||
8372|023|U|USES:  Losartan is used to treat high blood pressure||
8372|024|U|(hypertension) and to help protect the kidneys from damage due to||
8372|025|U|diabetes. It is also used to lower the risk of strokes in||
8372|026|U|patients with high blood pressure and an enlarged heart. Lowering||
8372|027|U|high blood pressure helps prevent strokes, heart attacks, and||
8372|028|U|kidney problems. Losartan belongs to a class of drugs called||
8372|029|U|angiotensin receptor blockers (ARBs). It works by relaxing blood||
8372|030|U|vessels so that blood can flow more easily.||
8372|031|B|||
8372|032|V|OTHER USES:  This section contains uses of this drug that are not||
8372|033|V|listed in the approved professional labeling for the drug but||
8372|034|V|that may be prescribed by your health care professional. Use this||
8372|035|V|drug for a condition that is listed in this section only if it||
8372|036|V|has been so prescribed by your health care professional.||
8372|037|V|   This drug may also be used for heart failure. It may also be||
8372|038|V|used for kidney disease.||
8372|039|B|||
8372|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8372|041|H|from your pharmacist before you start taking losartan and each||
8372|042|H|time you get a refill. If you have any questions, ask your doctor||
8372|043|H|or pharmacist.||
8372|044|H|   Take this medication by mouth with or without food as directed||
8372|045|H|by your doctor, usually once daily. The dosage is based on your||
8372|046|H|medical condition and response to treatment.||
8372|047|H|   If you are using the liquid form of this medication, shake the||
8372|048|H|bottle well for at least 20 seconds before each dose. Carefully||
8372|049|H|measure the dose using a special measuring device/spoon. Do not||
8372|050|H|use a household spoon because you may not get the correct dose.||
8372|051|H|   Use this medication regularly to get the most benefit from it.||
8372|052|H|To help you remember, take it at the same time each day. Keep||
8372|053|H|taking this medication even if you feel well. Most people with||
8372|054|H|high blood pressure do not feel sick.||
8372|055|H|   Tell your doctor if your condition does not get better or if||
8372|056|H|it gets worse (for example, your blood pressure readings remain||
8372|057|H|high or increase).||
8372|058|B|||
8372|059|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
8372|060|S|body adjusts to the medication. If any of these effects last or||
8372|061|S|get worse, tell your doctor or pharmacist promptly.||
8372|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
8372|063|S|slowly when rising from a sitting or lying position.||
8372|064|S|   Remember that this medication has been prescribed because your||
8372|065|S|doctor has judged that the benefit to you is greater than the||
8372|066|S|risk of side effects. Many people using this medication do not||
8372|067|S|have serious side effects.||
8372|068|S|   Tell your doctor right away if you have any serious side||
8372|069|S|effects, including: fainting, symptoms of a high potassium blood||
8372|070|S|level (such as muscle weakness, slow/irregular heartbeat).||
8372|071|S|   Although losartan may be used to prevent kidney problems or||
8372|072|S|treat people who have kidney problems, it may also rarely cause||
8372|073|S|serious kidney problems or make them worse. Your doctor will||
8372|074|S|check your kidney function while you are taking losartan. Tell||
8372|075|S|your doctor right away if you have any signs of kidney problems||
8372|076|S|such as a change in the amount of urine.||
8372|077|S|   A very serious allergic reaction to this drug is rare.||
8372|078|S|However, get medical help right away if you notice any symptoms||
8372|079|S|of a serious allergic reaction, including: rash, itching/swelling||
8372|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8372|081|S|breathing.||
8372|082|S|   This is not a complete list of possible side effects. If you||
8372|083|S|notice other effects not listed above, contact your doctor or||
8372|084|S|pharmacist.||
8372|085|S|   In the US -||
8372|086|S|   Call your doctor for medical advice about side effects. You||
8372|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8372|088|S|www.fda.gov/medwatch.||
8372|089|S|   In Canada - Call your doctor for medical advice about side||
8372|090|S|effects. You may report side effects to Health Canada at||
8372|091|S|1-866-234-2345.||
8372|092|B|||
8372|093|P|PRECAUTIONS:  Before taking losartan, tell your doctor or||
8372|094|P|pharmacist if you are allergic to it; or if you have any other||
8372|095|P|allergies. This product may contain inactive ingredients, which||
8372|096|P|can cause allergic reactions or other problems. Talk to your||
8372|097|P|pharmacist for more details.||
8372|098|P|   Before using this medication, tell your doctor or pharmacist||
8372|099|P|your medical history, especially of: liver disease, dehydration,||
8372|100|P|high level of potassium in the blood.||
8372|101|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
8372|102|P|can make you more dizzy. Do not drive, use machinery, or do||
8372|103|P|anything that needs alertness until you can do it safely. Limit||
8372|104|P|alcoholic beverages. Talk to your doctor if you are using||
8372|105|P|marijuana (cannabis).||
8372|106|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
8372|107|P|and cause you to feel lightheaded. Tell your doctor if you have||
8372|108|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
8372|109|P|of fluids unless your doctor tells you not to.||
8372|110|P|   This medication may increase your potassium levels. Before||
8372|111|P|using potassium supplements or salt substitutes that contain||
8372|112|P|potassium, consult your doctor or pharmacist.||
8372|113|P|   Before having surgery, tell your doctor or dentist about all||
8372|114|P|the products you use (including prescription drugs,||
8372|115|P|nonprescription drugs, and herbal products).||
8372|116|P|   Tell your doctor if you are pregnant or plan to become||
8372|117|P|pregnant. You should not become pregnant while using losartan.||
8372|118|P|Losartan may harm an unborn baby. If you become pregnant, talk to||
8372|119|P|your doctor right away about the risks and benefits of this||
8372|120|P|medication. (See also Warning section.)||
8372|121|P|   It is unknown if this drug passes into breast milk. Consult||
8372|122|P|your doctor before breastfeeding.||
8372|123|B|||
8372|124|I|DRUG INTERACTIONS:  See also Precautions section.||
8372|125|I|   Drug interactions may change how your medications work or||
8372|126|I|increase your risk for serious side effects. This document does||
8372|127|I|not contain all possible drug interactions. Keep a list of all||
8372|128|I|the products you use (including prescription/nonprescription||
8372|129|I|drugs and herbal products) and share it with your doctor and||
8372|130|I|pharmacist. Do not start, stop, or change the dosage of any||
8372|131|I|medicines without your doctor's approval.||
8372|132|I|   Some products that may interact with this drug include:||
8372|133|I|aliskiren, lithium, drugs that may increase the level of||
8372|134|I|potassium in the blood (such as sparsentan, ACE inhibitors||
8372|135|I|including benazepril/lisinopril, birth control pills containing||
8372|136|I|drospirenone).||
8372|137|I|   Some products have ingredients that could raise your blood||
8372|138|I|pressure or worsen your heart failure. Tell your pharmacist what||
8372|139|I|products you are using, and ask how to use them safely||
8372|140|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
8372|141|I|ibuprofen/naproxen).||
8372|142|B|||
8372|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
8372|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
8372|145|O|poison control center right away. US residents can call||
8372|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
8372|147|O|Symptoms of overdose may include: severe dizziness, fainting.||
8372|148|B|||
8372|149|N|NOTES:  Do not share this medication with others.||
8372|150|N|   Lifestyle changes such as stress reduction programs, exercise,||
8372|151|N|and dietary changes may increase the effectiveness of this||
8372|152|N|medicine. Talk to your doctor or pharmacist about lifestyle||
8372|153|N|changes that might benefit you.||
8372|154|N|   Lab and/or medical tests (such as kidney function, potassium||
8372|155|N|levels) should be done while you are taking this medication. Keep||
8372|156|N|all medical and lab appointments. Consult your doctor for more||
8372|157|N|details.||
8372|158|N|   Check your blood pressure regularly while taking this||
8372|159|N|medication. Learn how to monitor your own blood pressure, and||
8372|160|N|share the results with your doctor.||
8372|161|B|||
8372|162|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
8372|163|D|remember. If it is near the time of the next dose, skip the||
8372|164|D|missed dose. Take your next dose at the regular time. Do not||
8372|165|D|double the dose to catch up.||
8372|166|B|||
8372|167|R|STORAGE:  Store tablets at room temperature away from light and||
8372|168|R|moisture. Do not store in the bathroom. Keep all medications away||
8372|169|R|from children and pets.||
8372|170|R|   Different brands of the liquid form of this medication have||
8372|171|R|different storage needs. Check the product package for||
8372|172|R|instructions on how to store your brand, or ask your pharmacist.||
8372|173|R|   Do not flush medications down the toilet or pour them into a||
8372|174|R|drain unless instructed to do so. Properly discard this product||
8372|175|R|when it is expired or no longer needed. Consult your pharmacist||
8372|176|R|or local waste disposal company.||
8372|177|B|||
8372|178|A|Information last revised April 2025.||
8372|179|A|Copyright(c) 2025 First Databank, Inc.||
8372|180|B|||
8378|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
8378|002|Z|does NOT have all possible information about this product. This||
8378|003|Z|information does not assure that this product is safe, effective,||
8378|004|Z|or appropriate for you. This information is not individual||
8378|005|Z|medical advice and does not substitute for the advice of your||
8378|006|Z|health care professional. Always ask your health care||
8378|007|Z|professional for complete information about this product and your||
8378|008|Z|specific health needs.||
8378|009|B|||
8378|010|T|ESTRADIOL GEL - TRANSDERMAL||
8378|011|F|(ES-tra-DYE-ol)||
8378|012|B|||
8378|013|C|COMMON BRAND NAME(S): Divigel||
8378|014|B|||
8378|015|W|WARNING:  Estrogens, either used alone or with another hormone||
8378|016|W|(progestin), have rarely caused very serious side effects.||
8378|017|W|Discuss the risks and benefits of hormone treatment with your||
8378|018|W|doctor. Estrogens should not be used to prevent heart disease or||
8378|019|W|dementia.||
8378|020|W|   Estrogens can increase the risk of cancer of the uterus||
8378|021|W|(endometrial cancer). Taking a progestin as directed by your||
8378|022|W|doctor can help decrease this risk. Tell your doctor right away||
8378|023|W|if you have any unusual vaginal bleeding.||
8378|024|W|   In postmenopausal women, estrogens, taken with or without a||
8378|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
8378|026|W|stroke, dementia, and serious blood clots. When used along with a||
8378|027|W|progestin, estrogens also increase the risk of heart disease||
8378|028|W|(such as heart attacks).||
8378|029|W|   The risk for serious side effects may depend on the dose of||
8378|030|W|estrogen and the length of time it is used. This medication||
8378|031|W|should be used at the lowest effective dose and for the shortest||
8378|032|W|amount of time. Discuss the use of this medication with your||
8378|033|W|doctor regularly (for example, every 3 to 6 months) to see if you||
8378|034|W|still need to use it. If you will be taking this medication||
8378|035|W|long-term, you should have regular complete physical exams (for||
8378|036|W|example, once a year) as directed by your doctor. See also Notes||
8378|037|W|section.||
8378|038|B|||
8378|039|U|USES:  This medication is a hormone (estrogen). It is absorbed||
8378|040|U|through the skin and enters into the bloodstream. It is used by||
8378|041|U|women to help reduce a certain symptom of menopause (hot||
8378|042|U|flashes). Symptoms of menopause are caused by the body making||
8378|043|U|less estrogen. If you are using estrogens to treat only vaginal||
8378|044|U|symptoms of menopause (such as vaginal dryness/burning/itching),||
8378|045|U|products applied directly inside the vagina should be considered||
8378|046|U|before medications that are taken by mouth, absorbed through the||
8378|047|U|skin, or injected.||
8378|048|B|||
8378|049|V|OTHER USES:  This section contains uses of this drug that are not||
8378|050|V|listed in the approved professional labeling for the drug but||
8378|051|V|that may be prescribed by your health care professional. Use this||
8378|052|V|drug for a condition that is listed in this section only if it||
8378|053|V|has been so prescribed by your health care professional.||
8378|054|V|   Certain estrogen products may also be prescribed for bone loss||
8378|055|V|(osteoporosis) in women after menopause. However, there are other||
8378|056|V|medications (such as raloxifene, bisphosphonates including||
8378|057|V|alendronate) that are also effective in preventing bone loss and||
8378|058|V|may be safer. These medications should be considered for use||
8378|059|V|before estrogen treatment.||
8378|060|B|||
8378|061|H|HOW TO USE:  Read the Patient Information Leaflet if available||
8378|062|H|from your pharmacist before you start using this medication and||
8378|063|H|each time you get a refill. Learn how to apply the gel correctly.||
8378|064|H|If you have any questions, ask your doctor or pharmacist.||
8378|065|H|   Apply the medication to clean, dry skin on the upper thigh||
8378|066|H|area as directed by your doctor, usually once daily. Switch||
8378|067|H|between the right and left thigh with each application. Avoid||
8378|068|H|applying this medication to broken, irritated skin. Do not apply||
8378|069|H|this medication to the breast, face, or in or around the vagina.||
8378|070|H|Do not let others apply this medication to your body.||
8378|071|H|   The dosage is based on your medical condition and response to||
8378|072|H|treatment. Do not increase your dose or use this medication more||
8378|073|H|often than prescribed.||
8378|074|H|   After applying this medication, wash your hands thoroughly||
8378|075|H|with soap and water to reduce the risk of accidentally spreading||
8378|076|H|it from your hands to other people. Wait a few minutes for the||
8378|077|H|application site to dry completely before dressing. Cover the||
8378|078|H|application site with clothing (such as shorts or pants) to||
8378|079|H|prevent others from touching the application area and being||
8378|080|H|exposed to the drug. Wait at least 1 hour before allowing others||
8378|081|H|to touch the skin where the medication was applied. If someone||
8378|082|H|accidentally touches the gel (or the application area within 1||
8378|083|H|hour), have them wash the area of contact on their body with soap||
8378|084|H|and water as soon as possible.||
8378|085|H|   To get the best effect, wait at least 1 hour before||
8378|086|H|showering/swimming to allow the drug to be absorbed through the||
8378|087|H|skin.||
8378|088|H|   Use this medication regularly to get the most benefit from it.||
8378|089|H|To help you remember, use it at the same time each day.||
8378|090|H|   Avoid getting this medication in the eyes. If this medication||
8378|091|H|gets in the eyes, rinse them right away with warm water. Tell||
8378|092|H|your doctor if you get any eye irritation.||
8378|093|H|   This medication is flammable until dry. Avoid smoking or being||
8378|094|H|near open flames while using the medication and until the||
8378|095|H|medication has dried.||
8378|096|H|   Tell your doctor if your condition does not get better or if||
8378|097|H|it gets worse.||
8378|098|B|||
8378|099|S|SIDE EFFECTS:  See also Warning section.||
8378|100|S|   Nausea/vomiting, bloating, breast tenderness, headache, or||
8378|101|S|weight changes may occur. If any of these effects last or get||
8378|102|S|worse, tell your doctor or pharmacist promptly.||
8378|103|S|   Remember that this medication has been prescribed because your||
8378|104|S|doctor has judged that the benefit to you is greater than the||
8378|105|S|risk of side effects. Many people using this medication do not||
8378|106|S|have serious side effects.||
8378|107|S|   Tell your doctor right away if you have any serious side||
8378|108|S|effects, including: nausea/vomiting that doesn't stop,||
8378|109|S|mental/mood changes (such as depression, memory loss), breast||
8378|110|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
8378|111|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
8378|112|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
8378|113|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
8378|114|S|increased thirst/urination.||
8378|115|S|   This medication may rarely cause serious (sometimes fatal)||
8378|116|S|problems from blood clots (such as heart attack, stroke, blood||
8378|117|S|clots in the lungs or legs). Get medical help right away if you||
8378|118|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
8378|119|S|headaches, weakness on one side of the body, confusion, trouble||
8378|120|S|speaking, sudden vision changes, pain/swelling/warmth in the||
8378|121|S|groin/calf, shortness of breath/rapid breathing, sudden||
8378|122|S|dizziness/fainting.||
8378|123|S|   A very serious allergic reaction to this product is rare.||
8378|124|S|However, get medical help right away if you notice any symptoms||
8378|125|S|of a serious allergic reaction, including: rash, itching/swelling||
8378|126|S|(especially of the face/tongue/throat), severe dizziness, trouble||
8378|127|S|breathing.||
8378|128|S|   This is not a complete list of possible side effects. If you||
8378|129|S|notice other effects not listed above, contact your doctor or||
8378|130|S|pharmacist.||
8378|131|S|   In the US -||
8378|132|S|   Call your doctor for medical advice about side effects. You||
8378|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
8378|134|S|www.fda.gov/medwatch.||
8378|135|S|   In Canada - Call your doctor for medical advice about side||
8378|136|S|effects. You may report side effects to Health Canada at||
8378|137|S|1-866-234-2345.||
8378|138|B|||
8378|139|P|PRECAUTIONS:  Before using estradiol, tell your doctor or||
8378|140|P|pharmacist if you are allergic to it; or if you have any other||
8378|141|P|allergies. This product may contain inactive ingredients, which||
8378|142|P|can cause allergic reactions or other problems. Talk to your||
8378|143|P|pharmacist for more details.||
8378|144|P|   Before using this medication, tell your doctor or pharmacist||
8378|145|P|your medical history, especially of: vaginal bleeding of unknown||
8378|146|P|cause, certain cancers (such as breast cancer, cancer of the||
8378|147|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
8378|148|P|heart attack), liver disease, kidney disease, family medical||
8378|149|P|history (especially breast lumps, cancer, blood clots), family or||
8378|150|P|personal history of a certain swelling disorder (angioedema),||
8378|151|P|blood clotting disorders (such as protein C or protein S||
8378|152|P|deficiency), high blood pressure, diabetes, high||
8378|153|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
8378|154|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
8378|155|P|calcium in the blood), a certain hormone problem||
8378|156|P|(hypoparathyroidism), uterus problems (such as fibroids,||
8378|157|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
8378|158|P|headaches, mental/mood disorders (such as dementia, depression),||
8378|159|P|a certain blood disorder (porphyria).||
8378|160|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
8378|161|P|further increases your risk of stroke, blood clots, high blood||
8378|162|P|pressure, and heart attack, especially in women older than 35.||
8378|163|P|   Tell your doctor if you just had or will be having surgery, or||
8378|164|P|if you will be confined to a chair or bed for a long time (such||
8378|165|P|as a long plane flight). These conditions increase your risk of||
8378|166|P|getting blood clots, especially if you are using an estrogen||
8378|167|P|product. You may need to stop this medication for a time or take||
8378|168|P|special precautions.||
8378|169|P|   This drug may cause blotchy, dark areas on your face and skin||
8378|170|P|(melasma). Sunlight may worsen this effect. Limit your time in||
8378|171|P|the sun. Avoid tanning booths and sunlamps. Wear protective||
8378|172|P|clothing when outdoors. Ask your doctor or pharmacist about using||
8378|173|P|sunscreen with this medication. Sunscreen may affect the||
8378|174|P|absorption of this medication if applied on the area of the skin||
8378|175|P|where the medication was applied.||
8378|176|P|   If you are nearsighted or wear contact lenses, you may develop||
8378|177|P|vision problems or trouble wearing your contact lenses. Contact||
8378|178|P|your eye doctor if these problems occur.||
8378|179|P|   This product is not meant for children. Children may be||
8378|180|P|accidentally exposed to this medication by touching someone on||
8378|181|P|the area where the medication was applied. If this occurs, the||
8378|182|P|child may have unwanted side effects. Children should avoid||
8378|183|P|contact with any unclothed area where the medication has been||
8378|184|P|applied. Tell the doctor right away if you notice unexpected||
8378|185|P|signs of puberty in a child such as an increase in breast or||
8378|186|P|nipple size. To decrease this risk, carefully follow all||
8378|187|P|directions for the proper use of this drug.||
8378|188|P|   This medication should not be used during pregnancy. If you||
8378|189|P|become pregnant or think you may be pregnant, tell your doctor||
8378|190|P|right away.||
8378|191|P|   This medication passes into breast milk. Consult your doctor||
8378|192|P|before breastfeeding.||
8378|193|B|||
8378|194|I|DRUG INTERACTIONS:  Drug interactions may change how your||
8378|195|I|medications work or increase your risk for serious side effects.||
8378|196|I|This document does not contain all possible drug interactions.||
8378|197|I|Keep a list of all the products you use (including||
8378|198|I|prescription/nonprescription drugs and herbal products) and share||
8378|199|I|it with your doctor and pharmacist. Do not start, stop, or change||
8378|200|I|the dosage of any medicines without your doctor's approval.||
8378|201|I|   Some products that may interact with this drug include:||
8378|202|I|aromatase inhibitors (such as anastrozole, exemestane,||
8378|203|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
8378|204|I|tamoxifen, toremifene, tranexamic acid.||
8378|205|I|   This medication may interfere with certain lab tests, possibly||
8378|206|I|causing false test results. Make sure lab personnel and all your||
8378|207|I|doctors know you use this drug.||
8378|208|B|||
8378|209|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
8378|210|O|has overdosed and has serious symptoms such as passing out or||
8378|211|O|trouble breathing, call 911. Otherwise, call a poison control||
8378|212|O|center right away. US residents can call 1-800-222-1222. Canada||
8378|213|O|residents can call 1-844-764-7669. Symptoms of overdose may||
8378|214|O|include: severe nausea/vomiting, unusual vaginal bleeding.||
8378|215|B|||
8378|216|N|NOTES:  Do not share this medication with others.||
8378|217|N|   Regular complete physical exams which include lab and/or||
8378|218|N|medical tests (such as blood pressure, breast exam/mammogram,||
8378|219|N|pelvic exam, Pap smear) should be done while you are using this||
8378|220|N|medication. Follow your doctor's instructions for examining your||
8378|221|N|breasts, and report any lumps right away. Keep all medical and||
8378|222|N|lab appointments. Consult your doctor for more details.||
8378|223|N|   Preventing or controlling high blood pressure, high||
8378|224|N|cholesterol, and diabetes can help to reduce your chances of||
8378|225|N|heart disease and stroke. Lifestyle changes that can help to||
8378|226|N|control or prevent these diseases include reducing stress, eating||
8378|227|N|a low fat/salt diet, losing weight if overweight, exercising||
8378|228|N|regularly, and stopping smoking. Keep your mind active with||
8378|229|N|mental exercises (such as reading, solving crossword puzzles) to||
8378|230|N|help prevent dementia. Talk to your doctor about lifestyle||
8378|231|N|changes that might benefit you.||
8378|232|N|   Lifestyle changes that may help reduce hot flashes include||
8378|233|N|stopping smoking, dressing lightly or in layers,||
8378|234|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
8378|235|N|reducing stress, and exercising regularly.||
8378|236|B|||
8378|237|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
8378|238|D|If it is within 12 hours of the next dose, skip the missed dose.||
8378|239|D|Use your next dose at the regular time. Do not double the dose to||
8378|240|D|catch up.||
8378|241|B|||
8378|242|R|STORAGE:  Store at room temperature away from heat. Do not store||
8378|243|R|near an open flame. Do not open the pouch until you are ready to||
8378|244|R|use the medication. Keep all medications away from children and||
8378|245|R|pets.||
8378|246|R|   Do not flush medications down the toilet or pour them into a||
8378|247|R|drain unless instructed to do so. Properly discard this product||
8378|248|R|when it is expired or no longer needed. Consult your pharmacist||
8378|249|R|or local waste disposal company.||
8378|250|B|||
8378|251|A|Information last revised July 2025.||
8378|252|A|Copyright(c) 2025 First Databank, Inc.||
8378|253|B|||
9002|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9002|002|Z|does NOT have all possible information about this product. This||
9002|003|Z|information does not assure that this product is safe, effective,||
9002|004|Z|or appropriate for you. This information is not individual||
9002|005|Z|medical advice and does not substitute for the advice of your||
9002|006|Z|health care professional. Always ask your health care||
9002|007|Z|professional for complete information about this product and your||
9002|008|Z|specific health needs.||
9002|009|B|||
9002|010|T|AMILORIDE - ORAL||
9002|011|F|(a-MIL-oh-ride)||
9002|012|B|||
9002|013|C|COMMON BRAND NAME(S): Midamor||
9002|014|B|||
9002|015|W|WARNING:  This medication can cause high potassium levels||
9002|016|W|(hyperkalemia). This effect is more likely to occur in older||
9002|017|W|adults and in patients with kidney disease, diabetes, or a||
9002|018|W|serious illness. Potassium levels must be closely monitored on a||
9002|019|W|regular basis while taking this medication. If not treated, very||
9002|020|W|high potassium levels can sometimes be fatal. Tell your doctor||
9002|021|W|right away if you develop any symptoms of high potassium levels,||
9002|022|W|including muscle weakness, slow/irregular heartbeat,||
9002|023|W|numb/tingling skin.||
9002|024|B|||
9002|025|U|USES:  Amiloride is used with other "water pills"/diuretics (such||
9002|026|U|as furosemide, thiazide diuretics like hydrochlorothiazide) to||
9002|027|U|treat high blood pressure (hypertension), heart failure, or extra||
9002|028|U|fluid in the body (edema). Amiloride also helps to treat or||
9002|029|U|prevent low blood potassium levels caused by the other diuretics.||
9002|030|U|Lowering high blood pressure helps prevent strokes, heart||
9002|031|U|attacks, and kidney problems.||
9002|032|U|   Amiloride is called a "water pill" (diuretic) and causes your||
9002|033|U|body to get rid of extra salt and water while also preventing the||
9002|034|U|kidneys from getting rid of too much potassium.||
9002|035|B|||
9002|036|H|HOW TO USE:  Take this medication by mouth with food as directed||
9002|037|H|by your doctor, usually once daily. The dosage is based on your||
9002|038|H|medical condition and response to treatment.||
9002|039|H|   If you take this drug too close to bedtime, you may need to||
9002|040|H|wake up to urinate. It is best to take this medication at least 4||
9002|041|H|hours before your bedtime. If you have any questions about how||
9002|042|H|and when to take this medication, ask your doctor or pharmacist.||
9002|043|H|   Use this medication regularly in order to get the most benefit||
9002|044|H|from it. To help you remember, take it at the same time each day.||
9002|045|H|Keep taking this medication even if you feel well. Most people||
9002|046|H|with high blood pressure do not feel sick.||
9002|047|H|   Tell your doctor if your condition does not get better or if||
9002|048|H|it gets worse (for example, your blood pressure readings remain||
9002|049|H|high or increase).||
9002|050|B|||
9002|051|S|SIDE EFFECTS:  See also Warning section.||
9002|052|S|   Headache, dizziness, nausea, vomiting, loss of appetite,||
9002|053|S|stomach/abdominal pain, gas, or diarrhea may occur. If any of||
9002|054|S|these effects last or get worse, tell your doctor or pharmacist||
9002|055|S|promptly.||
9002|056|S|   Remember that this medication has been prescribed because your||
9002|057|S|doctor has judged that the benefit to you is greater than the||
9002|058|S|risk of side effects. Many people using this medication do not||
9002|059|S|have serious side effects.||
9002|060|S|   When given with other diuretics, this medication may cause||
9002|061|S|dehydration and electrolyte imbalance. Tell your doctor right||
9002|062|S|away if you have any symptoms of dehydration or electrolyte||
9002|063|S|imbalance, including unusual dry mouth/thirst, muscle||
9002|064|S|cramps/weakness, slow/fast/irregular heartbeat, or confusion.||
9002|065|S|   Tell your doctor right away if you have any serious side||
9002|066|S|effects, including: fainting, signs of liver problems (such as||
9002|067|S|nausea/vomiting that doesn't stop, yellowing eyes/skin, dark||
9002|068|S|urine), signs of kidney problems (such as change in the amount of||
9002|069|S|urine).||
9002|070|S|   A very serious allergic reaction to this drug is rare.||
9002|071|S|However, get medical help right away if you notice any symptoms||
9002|072|S|of a serious allergic reaction, including: rash, itching/swelling||
9002|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9002|074|S|breathing.||
9002|075|S|   This is not a complete list of possible side effects. If you||
9002|076|S|notice other effects not listed above, contact your doctor or||
9002|077|S|pharmacist.||
9002|078|S|   In the US -||
9002|079|S|   Call your doctor for medical advice about side effects. You||
9002|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9002|081|S|www.fda.gov/medwatch.||
9002|082|S|   In Canada - Call your doctor for medical advice about side||
9002|083|S|effects. You may report side effects to Health Canada at||
9002|084|S|1-866-234-2345.||
9002|085|B|||
9002|086|P|PRECAUTIONS:  See Also Warning section.||
9002|087|P|   Before taking amiloride, tell your doctor or pharmacist if you||
9002|088|P|are allergic to it; or if you have any other allergies. This||
9002|089|P|product may contain inactive ingredients, which can cause||
9002|090|P|allergic reactions or other problems. Talk to your pharmacist for||
9002|091|P|more details.||
9002|092|P|   Before using this medication, tell your doctor or pharmacist||
9002|093|P|your medical history, especially of: untreated salt/mineral||
9002|094|P|imbalance (such as high potassium, low sodium level), kidney||
9002|095|P|disease, liver disease, diabetes, dehydration.||
9002|096|P|   Before having surgery, tell your doctor or dentist about all||
9002|097|P|the products you use (including prescription drugs,||
9002|098|P|nonprescription drugs, and herbal products).||
9002|099|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9002|100|P|can make you more dizzy. Do not drive, use machinery, or do||
9002|101|P|anything that needs alertness until you can do it safely. Limit||
9002|102|P|alcoholic beverages. Talk to your doctor if you are using||
9002|103|P|marijuana (cannabis).||
9002|104|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
9002|105|P|and cause you to feel lightheaded. Tell your doctor if you have||
9002|106|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
9002|107|P|of fluids unless your doctor tells you not to.||
9002|108|P|   This drug may increase the potassium levels in your blood.||
9002|109|P|Limit foods high in potassium such as bananas and orange juice.||
9002|110|P|Consult your doctor or pharmacist before using any products||
9002|111|P|containing potassium (such as potassium supplements, salt||
9002|112|P|substitutes).||
9002|113|P|   During pregnancy, this medication should be used only when||
9002|114|P|clearly needed. Discuss the risks and benefits with your doctor.||
9002|115|P|   It is unknown if this drug passes into breast milk. Consult||
9002|116|P|your doctor before breastfeeding.||
9002|117|B|||
9002|118|I|DRUG INTERACTIONS:  See also Precautions section.||
9002|119|I|   Drug interactions may change how your medications work or||
9002|120|I|increase your risk for serious side effects. This document does||
9002|121|I|not contain all possible drug interactions. Keep a list of all||
9002|122|I|the products you use (including prescription/nonprescription||
9002|123|I|drugs and herbal products) and share it with your doctor and||
9002|124|I|pharmacist. Do not start, stop, or change the dosage of any||
9002|125|I|medicines without your doctor's approval.||
9002|126|I|   Some products that may interact with this drug are: lithium,||
9002|127|I|sodium phosphate products, other products that may increase||
9002|128|I|potassium levels (such as eplerenone, tacrolimus, cyclosporine,||
9002|129|I|birth control pills containing drospirenone, potassium-sparing||
9002|130|I|diuretics like spironolactone/triamterene, ACE inhibitors like||
9002|131|I|benazepril/captopril, angiotensin receptor antagonists like||
9002|132|I|losartan/valsartan).||
9002|133|I|   Some products have ingredients that could raise your blood||
9002|134|I|pressure or worsen your heart failure. Tell your pharmacist what||
9002|135|I|products you are using, and ask how to use them safely||
9002|136|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
9002|137|I|ibuprofen/naproxen).||
9002|138|I|   This medication may interfere with certain lab tests (such as||
9002|139|I|glucose tolerance testing), possibly causing false test results.||
9002|140|I|Make sure lab personnel and all your doctors know you use this||
9002|141|I|drug.||
9002|142|B|||
9002|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9002|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9002|145|O|poison control center right away. US residents can call||
9002|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9002|147|O|Symptoms of overdose may include: severe dizziness, fainting,||
9002|148|O|slow/irregular heartbeat.||
9002|149|B|||
9002|150|N|NOTES:  Do not share this medication with others.||
9002|151|N|   Lifestyle changes such as stress reduction programs, exercise,||
9002|152|N|and dietary changes may increase the effectiveness of this||
9002|153|N|medicine. Talk to your doctor or pharmacist about lifestyle||
9002|154|N|changes that might benefit you.||
9002|155|N|   Lab and/or medical tests (including kidney function, blood||
9002|156|N|mineral levels such as potassium) should be done while you are||
9002|157|N|taking this medication. Keep all medical and lab appointments.||
9002|158|N|Consult your doctor for more details.||
9002|159|N|   Check your blood pressure regularly while taking this||
9002|160|N|medication, especially when you first start this drug or when||
9002|161|N|your dose is changed. Learn how to monitor your own blood||
9002|162|N|pressure at home, and share the results with your doctor.||
9002|163|B|||
9002|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9002|165|D|remember. If it is near the time of the next dose, skip the||
9002|166|D|missed dose. Take your next dose at the regular time. Do not||
9002|167|D|double the dose to catch up.||
9002|168|B|||
9002|169|R|STORAGE:  Store at room temperature away from light and moisture.||
9002|170|R|Protect from freezing. Do not store in the bathroom. Keep all||
9002|171|R|medications away from children and pets.||
9002|172|R|   Do not flush medications down the toilet or pour them into a||
9002|173|R|drain unless instructed to do so. Properly discard this product||
9002|174|R|when it is expired or no longer needed. Consult your pharmacist||
9002|175|R|or local waste disposal company.||
9002|176|B|||
9002|177|A|Information last revised May 2024.||
9002|178|A|Copyright(c) 2025 First Databank, Inc.||
9002|179|B|||
9003|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9003|002|Z|does NOT have all possible information about this product. This||
9003|003|Z|information does not assure that this product is safe, effective,||
9003|004|Z|or appropriate for you. This information is not individual||
9003|005|Z|medical advice and does not substitute for the advice of your||
9003|006|Z|health care professional. Always ask your health care||
9003|007|Z|professional for complete information about this product and your||
9003|008|Z|specific health needs.||
9003|009|B|||
9003|010|T|DIFLUNISAL - ORAL||
9003|011|F|(dye-FLEW-niss-all)||
9003|012|B|||
9003|013|C|COMMON BRAND NAME(S): Dolobid||
9003|014|B|||
9003|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
9003|016|W|diflunisal) may rarely increase the risk for a heart attack or||
9003|017|W|stroke. This effect can happen at any time while taking this drug||
9003|018|W|but is more likely if you take it for a long time. The risk may||
9003|019|W|be greater in older adults or if you have heart disease or||
9003|020|W|increased risk for heart disease (for example, due to smoking,||
9003|021|W|family history of heart disease, or conditions such as high blood||
9003|022|W|pressure or diabetes). Do not take this drug right before or||
9003|023|W|after heart bypass surgery (CABG).||
9003|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
9003|025|W|bleeding from the stomach or intestines. This effect can occur||
9003|026|W|without warning symptoms at any time while taking this drug.||
9003|027|W|Older adults may be at higher risk for this effect.||
9003|028|W|   Stop taking diflunisal and get medical help right away if you||
9003|029|W|notice any of these rare but serious side effects:||
9003|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
9003|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
9003|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
9003|033|W|side of the body, trouble speaking, sudden vision changes.||
9003|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
9003|035|W|of taking this drug.||
9003|036|B|||
9003|037|U|USES:  Diflunisal is used to relieve mild to moderate pain from||
9003|038|U|various conditions. It also reduces pain, swelling, and joint||
9003|039|U|stiffness caused by arthritis. Reducing these symptoms helps you||
9003|040|U|do more of your normal daily activities. This medication is known||
9003|041|U|as a nonsteroidal anti-inflammatory drug (NSAID).||
9003|042|U|   This medication is not recommended for use in children under||
9003|043|U|12 years of age.||
9003|044|B|||
9003|045|V|OTHER USES:  This section contains uses of this drug that are not||
9003|046|V|listed in the approved professional labeling for the drug but||
9003|047|V|that may be prescribed by your health care professional. Use this||
9003|048|V|drug for a condition that is listed in this section only if it||
9003|049|V|has been so prescribed by your health care professional.||
9003|050|V|   This drug may also be used for gout attacks.||
9003|051|B|||
9003|052|H|HOW TO USE:  Read the Medication Guide provided by your||
9003|053|H|pharmacist before you start using diflunisal and each time you||
9003|054|H|get a refill. If you have any questions, ask your doctor or||
9003|055|H|pharmacist.||
9003|056|H|   Take this medication by mouth with a full glass of water (8||
9003|057|H|ounces or 240 milliliters) unless your doctor directs you||
9003|058|H|otherwise. Do not lie down for at least 10 minutes after taking||
9003|059|H|this drug. Take this medication with food/milk or right after||
9003|060|H|meals to prevent stomach upset.||
9003|061|H|   Swallow this medication whole. Do not crush or chew the||
9003|062|H|tablets. Doing so may increase side effects.||
9003|063|H|   The dosage is based on your medical condition and response to||
9003|064|H|treatment. Do not take more than 1,500 milligrams per day. To||
9003|065|H|minimize side effect risks (such as stomach bleeding), use this||
9003|066|H|medication at the lowest effective dose for the shortest possible||
9003|067|H|length of time. Do not increase your dose or take it more often||
9003|068|H|than prescribed. For ongoing conditions such as arthritis, keep||
9003|069|H|taking it as directed by your doctor. Discuss the risks and||
9003|070|H|benefits with your doctor or pharmacist.||
9003|071|H|   In certain conditions (such as arthritis), it may take up to 2||
9003|072|H|weeks of regular use before the full benefits of this drug take||
9003|073|H|effect.||
9003|074|H|   If you are taking this drug on an "as needed" basis (not on a||
9003|075|H|regular schedule), remember that pain medications work best if||
9003|076|H|they are used as the first signs of pain occur. If you wait until||
9003|077|H|the pain has significantly worsened, the medicine may not work as||
9003|078|H|well.||
9003|079|H|   Tell your doctor if your condition gets worse.||
9003|080|B|||
9003|081|S|SIDE EFFECTS:  See also Warning section.||
9003|082|S|   Upset stomach, heartburn, headache, tiredness, drowsiness, or||
9003|083|S|dizziness may occur. If any of these effects last or get worse,||
9003|084|S|tell your doctor or pharmacist promptly.||
9003|085|S|   Remember that this medication has been prescribed because your||
9003|086|S|doctor has judged that the benefit to you is greater than the||
9003|087|S|risk of side effects. Many people using this medication do not||
9003|088|S|have serious side effects.||
9003|089|S|   Tell your doctor right away if you have any serious side||
9003|090|S|effects, including: vision changes, hearing changes (such as||
9003|091|S|ringing in the ears), mental/mood changes (such as confusion,||
9003|092|S|hallucinations), fast/pounding heartbeat, fainting,||
9003|093|S|difficult/painful swallowing, signs of kidney problems (such as||
9003|094|S|change in the amount of urine), easy bruising/bleeding, symptoms||
9003|095|S|of heart failure (such as swelling ankles/feet, unusual||
9003|096|S|tiredness, unusual/sudden weight gain).||
9003|097|S|   This drug may rarely cause serious (possibly fatal) liver||
9003|098|S|disease. Get medical help right away if you have any symptoms of||
9003|099|S|liver damage, including: nausea/vomiting that doesn't stop,||
9003|100|S|yellowing eyes/skin, dark urine, unusual/extreme tiredness,||
9003|101|S|stomach/abdominal pain.||
9003|102|S|   A very serious allergic reaction to this drug is rare.||
9003|103|S|However, get medical help right away if you notice any symptoms||
9003|104|S|of a serious allergic reaction, including: fever, swollen lymph||
9003|105|S|nodes, rash, itching/swelling (especially of the||
9003|106|S|face/tongue/throat), severe dizziness, trouble breathing.||
9003|107|S|   This is not a complete list of possible side effects. If you||
9003|108|S|notice other effects not listed above, contact your doctor or||
9003|109|S|pharmacist.||
9003|110|S|   In the US -||
9003|111|S|   Call your doctor for medical advice about side effects. You||
9003|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9003|113|S|www.fda.gov/medwatch.||
9003|114|S|   In Canada - Call your doctor for medical advice about side||
9003|115|S|effects. You may report side effects to Health Canada at||
9003|116|S|1-866-234-2345.||
9003|117|B|||
9003|118|P|PRECAUTIONS:  See also Warning section.||
9003|119|P|   Before taking diflunisal, tell your doctor or pharmacist if||
9003|120|P|you are allergic to it; or to aspirin or other salicylates (such||
9003|121|P|as choline salicylate), or other NSAIDs (such as ibuprofen,||
9003|122|P|naproxen, celecoxib); or if you have any other allergies. This||
9003|123|P|product may contain inactive ingredients, which can cause||
9003|124|P|allergic reactions or other problems. Talk to your pharmacist for||
9003|125|P|more details.||
9003|126|P|   Before using this medication, tell your doctor or pharmacist||
9003|127|P|your medical history, especially of: asthma (including a history||
9003|128|P|of worsening breathing after taking aspirin or other NSAIDs),||
9003|129|P|liver disease, diabetes, stomach/intestine/esophagus problems||
9003|130|P|(such as bleeding, ulcers), heart disease (such as history of||
9003|131|P|heart attack), stroke, high blood pressure, swelling (edema,||
9003|132|P|fluid retention), blood disorders (such as anemia), bleeding or||
9003|133|P|clotting problems, growths in the nose (nasal polyps).||
9003|134|P|   Kidney problems can sometimes occur with the use of NSAID||
9003|135|P|medications, including diflunisal. Problems are more likely to||
9003|136|P|occur if you are dehydrated, have heart failure or kidney||
9003|137|P|disease, are an older adult, or if you take certain medications||
9003|138|P|(see also Drug Interactions section). Drink plenty of fluids as||
9003|139|P|directed by your doctor to prevent dehydration and tell your||
9003|140|P|doctor right away if you have a change in the amount of urine.||
9003|141|P|   Before having surgery, tell your doctor or dentist about all||
9003|142|P|the products you use (including prescription drugs,||
9003|143|P|nonprescription drugs, and herbal products).||
9003|144|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9003|145|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9003|146|P|machinery, or do anything that needs alertness until you can do||
9003|147|P|it safely. Talk to your doctor if you are using marijuana||
9003|148|P|(cannabis).||
9003|149|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
9003|150|P|and tobacco may increase your risk for stomach bleeding,||
9003|151|P|especially when combined with this medicine. Limit alcohol and||
9003|152|P|stop smoking. Consult your doctor or pharmacist for more||
9003|153|P|information.||
9003|154|P|   Older adults may be more sensitive to the side effects of this||
9003|155|P|drug, especially stomach/intestinal bleeding and kidney problems.||
9003|156|P|   Since diflunisal is related to aspirin, children and teenagers||
9003|157|P|younger than 18 years should not take diflunisal if they have||
9003|158|P|chickenpox, influenza, or any undiagnosed illness without first||
9003|159|P|consulting a doctor about Reye's syndrome, a rare but serious||
9003|160|P|illness.||
9003|161|P|   Before using this medication, women of childbearing age should||
9003|162|P|talk with their doctor(s) about the benefits and risks. Tell your||
9003|163|P|doctor if you are pregnant or if you plan to become pregnant.||
9003|164|P|This medication may harm an unborn baby and cause problems with||
9003|165|P|normal labor/delivery. It is not recommended for use in pregnancy||
9003|166|P|from 20 weeks until delivery. If your doctor decides that you||
9003|167|P|need to use this medication between 20 and 30 weeks of pregnancy,||
9003|168|P|you should use the lowest effective dose for the shortest||
9003|169|P|possible time. You should not use this medication after 30 weeks||
9003|170|P|of pregnancy.||
9003|171|P|   This drug passes into breast milk. Breastfeeding is not||
9003|172|P|recommended while using this drug. Consult your doctor before||
9003|173|P|breastfeeding.||
9003|174|B|||
9003|175|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9003|176|I|medications work or increase your risk for serious side effects.||
9003|177|I|This document does not contain all possible drug interactions.||
9003|178|I|Keep a list of all the products you use (including||
9003|179|I|prescription/nonprescription drugs and herbal products) and share||
9003|180|I|it with your doctor and pharmacist. Do not start, stop, or change||
9003|181|I|the dosage of any medicines without your doctor's approval.||
9003|182|I|   Some products that may interact with this drug include:||
9003|183|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
9003|184|I|angiotensin II receptor blockers (such as losartan, valsartan),||
9003|185|I|antacids (regular use), cidofovir, corticosteroids (such as||
9003|186|I|prednisone), digoxin, live influenza vaccine, lithium,||
9003|187|I|methotrexate, pemetrexed, probenecid, "water pills" (diuretics||
9003|188|I|such as furosemide, hydrochlorothiazide, triamterene).||
9003|189|I|   This medication may increase the risk of bleeding when taken||
9003|190|I|with other drugs that also may cause bleeding. Examples include||
9003|191|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
9003|192|I|dabigatran/enoxaparin/warfarin, among others.||
9003|193|I|   Check all prescription and nonprescription medicine labels||
9003|194|I|carefully since many contain pain relievers/fever reducers||
9003|195|I|(NSAIDs such as aspirin, ibuprofen, indomethacin, ketorolac or||
9003|196|I|naproxen) which if taken together with diflunisal may increase||
9003|197|I|your risk for side effects. However, if your doctor has told you||
9003|198|I|to take low-dose aspirin to prevent heart attack or stroke||
9003|199|I|(usually 81-162 milligrams a day), you should keep taking the||
9003|200|I|aspirin unless your doctor tells you not to. Ask your doctor or||
9003|201|I|pharmacist for more details.||
9003|202|I|   This medication may interfere with certain lab tests, possibly||
9003|203|I|causing false test results. Make sure lab personnel and all your||
9003|204|I|doctors know you use this drug.||
9003|205|B|||
9003|206|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9003|207|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9003|208|O|poison control center right away. US residents can call||
9003|209|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9003|210|O|Symptoms of overdose may include severe stomach pain, vomit that||
9003|211|O|looks like coffee grounds, extreme drowsiness, fast breathing,||
9003|212|O|confusion, loss of consciousness.||
9003|213|B|||
9003|214|N|NOTES:  Do not share this medication with others.||
9003|215|N|   Lab and/or medical tests (such as complete blood count,||
9003|216|N|liver/kidney function) may be done while you are taking this||
9003|217|N|medication. Keep all medical and lab appointments. Consult your||
9003|218|N|doctor for more details.||
9003|219|N|   Non-drug treatment for arthritis that is approved by your||
9003|220|N|doctor (such as weight loss if needed, strengthening and||
9003|221|N|conditioning exercises) may help improve your flexibility, range||
9003|222|N|of motion, and joint function. Consult your doctor for specific||
9003|223|N|instructions.||
9003|224|B|||
9003|225|D|MISSED DOSE:  If you are prescribed this drug on a regular||
9003|226|D|schedule (not just "as needed") and you miss a dose, take it as||
9003|227|D|soon as you remember. If it is near the time of the next dose,||
9003|228|D|skip the missed dose. Take your next dose at the regular time. Do||
9003|229|D|not double the dose to catch up.||
9003|230|B|||
9003|231|R|STORAGE:  Store at room temperature away from light and moisture.||
9003|232|R|Do not store in the bathroom. Keep all medications away from||
9003|233|R|children and pets.||
9003|234|R|   Do not flush medications down the toilet or pour them into a||
9003|235|R|drain unless instructed to do so. Properly discard this product||
9003|236|R|when it is expired or no longer needed. Consult your pharmacist||
9003|237|R|or local waste disposal company.||
9003|238|B|||
9003|239|A|Information last revised November 2024.||
9003|240|A|Copyright(c) 2025 First Databank, Inc.||
9003|241|B|||
9005|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9005|002|Z|does NOT have all possible information about this product. This||
9005|003|Z|information does not assure that this product is safe, effective,||
9005|004|Z|or appropriate for you. This information is not individual||
9005|005|Z|medical advice and does not substitute for the advice of your||
9005|006|Z|health care professional. Always ask your health care||
9005|007|Z|professional for complete information about this product and your||
9005|008|Z|specific health needs.||
9005|009|B|||
9005|010|T|CARBAMAZEPINE EXTENDED-RELEASE - ORAL||
9005|011|F|(KAR-ba-MAZ-e-peen)||
9005|012|B|||
9005|013|C|COMMON BRAND NAME(S):  Tegretol XR, Carbatrol, Equetro||
9005|014|B|||
9005|015|W|WARNING:  Carbamazepine may rarely cause very serious (possibly||
9005|016|W|fatal) skin reactions. Some people in certain ethnic groups (such||
9005|017|W|as people of Asian/South Asian descent) are at greater risk. Your||
9005|018|W|doctor may order a blood test to measure your risk before you||
9005|019|W|start this medication. If the blood test shows you are at greater||
9005|020|W|risk, your doctor should discuss the risks and benefits of||
9005|021|W|carbamazepine and other treatment choices with you. Such skin||
9005|022|W|reactions have developed mostly within the first few months of||
9005|023|W|treatment. Get medical help right away if you develop any of the||
9005|024|W|following symptoms: skin rash/blisters/peeling, itching, or||
9005|025|W|swelling. Ask your doctor or pharmacist for more details.||
9005|026|W|   This drug has rarely caused very serious blood disorders||
9005|027|W|(aplastic anemia, agranulocytosis). Your doctor will monitor your||
9005|028|W|blood counts to minimize the chance of these side effects. Keep||
9005|029|W|all medical and lab appointments. Get medical help right away if||
9005|030|W|any of these rare but very serious side effects occur: signs of||
9005|031|W|infection (such as sore throat that doesn't go away, fever,||
9005|032|W|chills, swollen lymph nodes), unusual weakness/tiredness,||
9005|033|W|shortness of breath, or easy bleeding/bruising.||
9005|034|B|||
9005|035|U|USES:  Carbamazepine is used to prevent and control seizures.||
9005|036|U|This medication is known as an anticonvulsant or anti-epileptic||
9005|037|U|drug. It is also used to relieve certain types of nerve pain||
9005|038|U|(such as trigeminal neuralgia). This medication works by reducing||
9005|039|U|the spread of seizure activity in the brain and restoring the||
9005|040|U|normal balance of nerve activity.||
9005|041|U|   Some forms of this medication are also used to treat bipolar||
9005|042|U|disorder. Carbamazepine can help to decrease extreme changes in||
9005|043|U|mood and help you feel less agitated.||
9005|044|B|||
9005|045|H|HOW TO USE:  Read the Medication Guide provided by your||
9005|046|H|pharmacist before you start taking carbamazepine and each time||
9005|047|H|you get a refill. If you have any questions, ask your doctor or||
9005|048|H|pharmacist.||
9005|049|H|   If you are taking the extended-release tablets, take this||
9005|050|H|medication by mouth with food as directed by your doctor, usually||
9005|051|H|2 times a day. Do not crush or chew extended-release tablets.||
9005|052|H|Doing so can release all of the drug at once, increasing the risk||
9005|053|H|of side effects. Also, do not split the tablets unless they have||
9005|054|H|a score line and your doctor or pharmacist tells you to do so.||
9005|055|H|Swallow the whole or split tablet without crushing or chewing.||
9005|056|H|Inspect the tablets for chips and cracks. Do not take any damaged||
9005|057|H|tablets.||
9005|058|H|   If you are taking the extended-release capsules, take this||
9005|059|H|medication by mouth with or without food as directed by your||
9005|060|H|doctor, usually 2 times a day. Swallow the capsules whole. Do not||
9005|061|H|crush or chew the capsules.||
9005|062|H|   If you have trouble swallowing the capsules, you may open them||
9005|063|H|and sprinkle the contents onto a teaspoonful of applesauce or||
9005|064|H|other soft food. Swallow all of the drug/food mixture right away.||
9005|065|H|Do not chew the mixture or prepare a supply in advance.||
9005|066|H|   The dosage is based on your medical condition and response to||
9005|067|H|treatment. To reduce your risk of side effects, your doctor may||
9005|068|H|direct you to start this medication at a low dose and gradually||
9005|069|H|increase your dose. Follow your doctor's instructions carefully.||
9005|070|H|   Avoid eating grapefruit or drinking grapefruit juice while||
9005|071|H|using this medication unless your doctor or pharmacist says you||
9005|072|H|may do so safely. Grapefruit can increase the chance of side||
9005|073|H|effects with this medicine. Ask your doctor or pharmacist for||
9005|074|H|more details.||
9005|075|H|   Take this medication regularly to get the most benefit from||
9005|076|H|it. To help you remember, take it at the same times each day.||
9005|077|H|Keep taking this medication even if you feel well.||
9005|078|H|   Do not stop taking this medication without consulting your||
9005|079|H|doctor. Some conditions (such as seizures) may become worse when||
9005|080|H|this drug is suddenly stopped. Your dose may need to be gradually||
9005|081|H|decreased.||
9005|082|H|   Tell your doctor if your condition does not get better or if||
9005|083|H|it gets worse.||
9005|084|B|||
9005|085|S|SIDE EFFECTS:  See also Warning section.||
9005|086|S|   Nausea, vomiting, dizziness, drowsiness, constipation, dry||
9005|087|S|mouth, or unsteadiness may occur. If any of these effects last or||
9005|088|S|get worse, tell your doctor or pharmacist promptly.||
9005|089|S|   An empty tablet shell may appear in your stool. This effect is||
9005|090|S|harmless because your body has already absorbed the medication.||
9005|091|S|   Remember that this medication has been prescribed because your||
9005|092|S|doctor has judged that the benefit to you is greater than the||
9005|093|S|risk of side effects. Many people using this medication do not||
9005|094|S|have serious side effects.||
9005|095|S|   Tell your doctor right away if you have any serious side||
9005|096|S|effects, including: headaches that are severe or don't go away,||
9005|097|S|signs of liver problems (such as nausea/vomiting that doesn't||
9005|098|S|stop, loss of appetite, stomach/abdominal pain, yellowing||
9005|099|S|eyes/skin, dark urine), signs of kidney problems (such as change||
9005|100|S|in the amount of urine), mouth sores, fainting,||
9005|101|S|fast/slow/irregular heartbeat, unusual eye movements (nystagmus),||
9005|102|S|vision changes (such as blurred vision), joint pain, swelling of||
9005|103|S|the ankles/feet, pain/redness/swelling of the arms or legs,||
9005|104|S|numbness/tingling of the hands/feet, signs of low levels of||
9005|105|S|sodium in the blood (such as severe drowsiness, mental/mood||
9005|106|S|changes including confusion, seizures).||
9005|107|S|   A small number of people who take anticonvulsants for any||
9005|108|S|condition (such as seizure, bipolar disorder, pain) may||
9005|109|S|experience depression, suicidal thoughts/attempts, or other||
9005|110|S|mental/mood problems. Tell your doctor right away if you or your||
9005|111|S|family/caregiver notice any unusual/sudden changes in your mood,||
9005|112|S|thoughts, or behavior such as signs of depression, suicidal||
9005|113|S|thoughts/attempts, thoughts about harming yourself.||
9005|114|S|   A very serious allergic reaction to this drug is rare.||
9005|115|S|However, get medical help right away if you notice any symptoms||
9005|116|S|of a serious allergic reaction, including: rash, itching/swelling||
9005|117|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9005|118|S|breathing.||
9005|119|S|   This is not a complete list of possible side effects. If you||
9005|120|S|notice other effects not listed above, contact your doctor or||
9005|121|S|pharmacist.||
9005|122|S|   In the US -||
9005|123|S|   Call your doctor for medical advice about side effects. You||
9005|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9005|125|S|www.fda.gov/medwatch.||
9005|126|S|   In Canada - Call your doctor for medical advice about side||
9005|127|S|effects. You may report side effects to Health Canada at||
9005|128|S|1-866-234-2345.||
9005|129|B|||
9005|130|P|PRECAUTIONS:  Before taking carbamazepine, tell your doctor or||
9005|131|P|pharmacist if you are allergic to it; or to other anti-seizure||
9005|132|P|medications (such as fosphenytoin, oxcarbazepine, phenobarbital,||
9005|133|P|phenytoin, primidone) or to tricyclic antidepressants (such as||
9005|134|P|amitriptyline, desipramine); or if you have any other allergies.||
9005|135|P|This product may contain inactive ingredients, which can cause||
9005|136|P|allergic reactions or other problems. Talk to your pharmacist for||
9005|137|P|more details.||
9005|138|P|   Before using this medication, tell your doctor or pharmacist||
9005|139|P|your medical history, especially of: decreased bone marrow||
9005|140|P|function (bone marrow depression), blood disorders (such as||
9005|141|P|porphyria, anemia), glaucoma, heart disease (such as coronary||
9005|142|P|artery disease, heart failure, irregular heartbeat), kidney||
9005|143|P|disease, liver disease, mental/mood disorders (such as||
9005|144|P|depression), mineral imbalances (such as low levels of sodium or||
9005|145|P|calcium in the blood).||
9005|146|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9005|147|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9005|148|P|machinery, or do anything that needs alertness until you can do||
9005|149|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
9005|150|P|are using marijuana (cannabis).||
9005|151|P|   This medication may make you more sensitive to the sun. Limit||
9005|152|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9005|153|P|sunscreen and wear protective clothing when outdoors. Get medical||
9005|154|P|help right away if you get sunburned or have skin||
9005|155|P|blisters/redness.||
9005|156|P|   Before having surgery, tell your doctor or dentist about all||
9005|157|P|the products you use (including prescription drugs,||
9005|158|P|nonprescription drugs, and herbal products).||
9005|159|P|   Older adults may be more sensitive to the side effects of this||
9005|160|P|drug, especially confusion, unsteadiness, or irregular heartbeat.||
9005|161|P|Confusion and unsteadiness can increase the risk of falling.||
9005|162|P|Older adults may also be at greater risk of developing a type of||
9005|163|P|mineral imbalance (low levels of sodium in the blood), especially||
9005|164|P|if they are also taking "water pills" (diuretics).||
9005|165|P|   During pregnancy, this medication should be used only when||
9005|166|P|clearly needed. It may harm an unborn baby. However, since||
9005|167|P|untreated seizures or bipolar disorder are serious conditions||
9005|168|P|that can harm both a pregnant woman and her unborn baby, do not||
9005|169|P|stop taking this medication unless directed by your doctor. If||
9005|170|P|you are planning pregnancy, become pregnant, or think you may be||
9005|171|P|pregnant, discuss with your doctor right away the benefits and||
9005|172|P|risks of using this medication during pregnancy. If you are||
9005|173|P|pregnant, prenatal care that includes tests for birth defects is||
9005|174|P|recommended. Since birth control pills, patches, implants, and||
9005|175|P|injections may not work if used with this medication (see also||
9005|176|P|Drug Interactions section), discuss reliable forms of birth||
9005|177|P|control with your doctor.||
9005|178|P|   This medication passes into breast milk. Consult your doctor||
9005|179|P|before breastfeeding.||
9005|180|B|||
9005|181|I|DRUG INTERACTIONS:  See also How to Use section.||
9005|182|I|   Drug interactions may change how your medications work or||
9005|183|I|increase your risk for serious side effects. This document does||
9005|184|I|not contain all possible drug interactions. Keep a list of all||
9005|185|I|the products you use (including prescription/nonprescription||
9005|186|I|drugs and herbal products) and share it with your doctor and||
9005|187|I|pharmacist. Do not start, stop, or change the dosage of any||
9005|188|I|medicines without your doctor's approval.||
9005|189|I|   Some products that may interact with this drug are: certain||
9005|190|I|azole antifungals (isavuconazonium, voriconazole), orlistat.||
9005|191|I|   Taking MAO inhibitors with this medication may cause a serious||
9005|192|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9005|193|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9005|194|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9005|195|I|selegiline, tranylcypromine) during treatment with this||
9005|196|I|medication. Most MAO inhibitors should also not be taken for two||
9005|197|I|weeks before treatment with this medication. Ask your doctor when||
9005|198|I|to start or stop taking this medication.||
9005|199|I|   Other medications can affect the removal of carbamazepine from||
9005|200|I|your body, which may affect how carbamazepine works. Examples||
9005|201|I|include macrolide antibiotics (such as erythromycin), rifamycins||
9005|202|I|(such as rifabutin), St. John's wort, among others.||
9005|203|I|   Carbamazepine can speed up the removal of other drugs from||
9005|204|I|your body, which may affect how they work. Examples of affected||
9005|205|I|drugs include artemether/lumefantrine, certain drugs used to||
9005|206|I|prevent blood clots (anticoagulants such as apixaban,||
9005|207|I|rivaroxaban), certain calcium channel blockers (such as||
9005|208|I|nifedipine, nimodipine), nefazodone, nirmatrelvir, HIV NNRTIs||
9005|209|I|(such as efavirenz, etravirine, rilpivirine), praziquantel,||
9005|210|I|ranolazine, among others.||
9005|211|I|   This medication may decrease the effectiveness of hormonal||
9005|212|I|birth control such as pills, patch, or ring. This could cause||
9005|213|I|pregnancy. Discuss with your doctor or pharmacist if you should||
9005|214|I|use reliable backup birth control methods while taking this||
9005|215|I|medication. Also tell your doctor if you have any new spotting or||
9005|216|I|breakthrough bleeding, because these may be signs that your birth||
9005|217|I|control is not working well.||
9005|218|I|   Tell your doctor or pharmacist if you are taking other||
9005|219|I|products that cause drowsiness including alcohol, marijuana||
9005|220|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
9005|221|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
9005|222|I|zolpidem), muscle relaxants (such as carisoprodol,||
9005|223|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
9005|224|I|hydrocodone).||
9005|225|I|   Check the labels on all your medicines (such as allergy or||
9005|226|I|cough-and-cold products) because they may contain ingredients||
9005|227|I|that cause drowsiness. Ask your pharmacist about using those||
9005|228|I|products safely.||
9005|229|I|   This medication may interfere with certain lab tests (such as||
9005|230|I|thyroid function, some pregnancy tests), possibly causing false||
9005|231|I|test results. Make sure lab personnel and all your doctors know||
9005|232|I|you use this drug.||
9005|233|B|||
9005|234|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9005|235|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9005|236|O|poison control center right away. US residents can call||
9005|237|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9005|238|O|Symptoms of overdose may include: slowed breathing, loss of||
9005|239|O|consciousness, muscle twitching, uncontrolled movements, very||
9005|240|O|fast heartbeat.||
9005|241|B|||
9005|242|N|NOTES:  Do not share this medication with others.||
9005|243|N|   Lab and/or medical tests (such as complete blood count, blood||
9005|244|N|mineral levels, kidney/liver function, eye exams, carbamazepine||
9005|245|N|blood levels) should be done before you start taking this||
9005|246|N|medication and while you are taking it. Keep all medical and lab||
9005|247|N|appointments. Consult your doctor for more details.||
9005|248|B|||
9005|249|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9005|250|D|remember. If it is near the time of the next dose, skip the||
9005|251|D|missed dose. Take your next dose at the regular time. Do not||
9005|252|D|double the dose to catch up.||
9005|253|B|||
9005|254|R|STORAGE:  Store at room temperature away from light and moisture.||
9005|255|R|Do not store in the bathroom. Keep all medications away from||
9005|256|R|children and pets.||
9005|257|R|   Do not flush medications down the toilet or pour them into a||
9005|258|R|drain unless instructed to do so. Properly discard this product||
9005|259|R|when it is expired or no longer needed. Consult your pharmacist||
9005|260|R|or local waste disposal company.||
9005|261|B|||
9005|262|M|MEDICAL ALERT:  Your condition can cause complications in a||
9005|263|M|medical emergency. For information about enrolling in MedicAlert,||
9005|264|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9005|265|B|||
9005|266|A|Information last revised May 2025.||
9005|267|A|Copyright(c) 2025 First Databank, Inc.||
9005|268|B|||
9006|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9006|002|Z|does NOT have all possible information about this product. This||
9006|003|Z|information does not assure that this product is safe, effective,||
9006|004|Z|or appropriate for you. This information is not individual||
9006|005|Z|medical advice and does not substitute for the advice of your||
9006|006|Z|health care professional. Always ask your health care||
9006|007|Z|professional for complete information about this product and your||
9006|008|Z|specific health needs.||
9006|009|B|||
9006|010|T|CLIDINIUM/CHLORDIAZEPOXIDE - ORAL||
9006|011|F|(kli-DIN-ee-um/KLOR-dye-AZ-e-POX-ide)||
9006|012|B|||
9006|013|C|COMMON BRAND NAME(S): Librax||
9006|014|B|||
9006|015|W|WARNING:  Chlordiazepoxide has a risk for abuse and addiction,||
9006|016|W|which can lead to overdose and death. Taking this medication with||
9006|017|W|alcohol or other drugs that can cause drowsiness or breathing||
9006|018|W|problems (especially opioid medications such as codeine,||
9006|019|W|hydrocodone) may cause very serious side effects, including||
9006|020|W|death. To lower your risk, your doctor should have you take the||
9006|021|W|smallest dose of chlordiazepoxide that works, and take it for the||
9006|022|W|shortest possible time. Be sure you know how to take||
9006|023|W|chlordiazepoxide and what other drugs you should avoid taking||
9006|024|W|with it. See also Drug Interactions section. Get medical help||
9006|025|W|right away if any of these very serious side effects occur:||
9006|026|W|slow/shallow breathing, unusual lightheadedness, severe||
9006|027|W|drowsiness/dizziness, difficulty waking up.||
9006|028|W|   Suddenly stopping this medication may cause serious (possibly||
9006|029|W|fatal) withdrawal, especially if you have used it for a long time||
9006|030|W|or in high doses. To prevent withdrawal, your doctor may lower||
9006|031|W|your dose slowly. Tell your doctor or pharmacist right away if||
9006|032|W|you have any withdrawal symptoms such as headaches, trouble||
9006|033|W|sleeping, restlessness, hallucinations/confusion, depression,||
9006|034|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
9006|035|W|to months.||
9006|036|B|||
9006|037|U|USES:  This medication is a combination of 2 drugs, clidinium and||
9006|038|U|chlordiazepoxide. It is used along with other medications to help||
9006|039|U|treat stomach/intestinal disorders (such as ulcers, irritable||
9006|040|U|bowel syndrome, bowel infections). Clidinium helps to reduce the||
9006|041|U|symptoms of stomach and intestinal cramping. It works by slowing||
9006|042|U|the natural movements of the gut and by relaxing the muscles in||
9006|043|U|the stomach and intestines. Clidinium belongs to a class of drugs||
9006|044|U|known as anticholinergics/antispasmodics. Chlordiazepoxide helps||
9006|045|U|to reduce anxiety. It acts on the brain and nerves to produce a||
9006|046|U|calming effect. It belongs to a class of drugs known as||
9006|047|U|benzodiazepines.||
9006|048|B|||
9006|049|V|OTHER USES:  This section contains uses of this drug that are not||
9006|050|V|listed in the approved professional labeling for the drug but||
9006|051|V|that may be prescribed by your health care professional. Use this||
9006|052|V|drug for a condition that is listed in this section only if it||
9006|053|V|has been so prescribed by your health care professional.||
9006|054|V|   This drug may also be used to relieve the symptoms of||
9006|055|V|irritable bowel syndrome.||
9006|056|B|||
9006|057|H|HOW TO USE:  See also Warning section.||
9006|058|H|   Read the Medication Guide provided by your pharmacist before||
9006|059|H|you start taking clidinium/chlordiazepoxide and each time you get||
9006|060|H|a refill. If you have any questions, ask your doctor or||
9006|061|H|pharmacist.||
9006|062|H|   Take this medication by mouth as directed by your doctor,||
9006|063|H|usually 3 to 4 times a day (30 to 60 minutes before meals and at||
9006|064|H|bedtime).||
9006|065|H|   If you are taking an antacid, take it after meals and take||
9006|066|H|this medication before meals.||
9006|067|H|   The dosage is based on your age, medical condition, and||
9006|068|H|response to treatment. Older adults usually start with a lower||
9006|069|H|dose to decrease the risk of side effects.||
9006|070|H|   Do not increase your dose or take this drug more often without||
9006|071|H|your doctor's approval. Your condition will not improve any||
9006|072|H|faster and the risk of serious side effects may increase.||
9006|073|H|   When this medication is used for a long time, it may not work||
9006|074|H|as well. Your doctor may need to increase your dose or change||
9006|075|H|your medication. Talk with your doctor if this medication stops||
9006|076|H|working well.||
9006|077|H|   Though it helps many people, this medication may sometimes||
9006|078|H|cause addiction. This risk may be higher if you have a substance||
9006|079|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
9006|080|H|Take this medication exactly as prescribed to lower the risk of||
9006|081|H|addiction. Ask your doctor or pharmacist for more details.||
9006|082|H|   Tell your doctor if your condition lasts or gets worse.||
9006|083|B|||
9006|084|S|SIDE EFFECTS:  See also Warning section.||
9006|085|S|   Dizziness, drowsiness, weakness, blurred vision, dry eyes, dry||
9006|086|S|mouth, nausea, constipation, and abdominal bloating may occur. If||
9006|087|S|any of these effects last or get worse, tell your doctor or||
9006|088|S|pharmacist promptly.||
9006|089|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
9006|090|S|chips, chew (sugarless) gum, drink water, or use a saliva||
9006|091|S|substitute. To relieve dry eyes, consult your pharmacist for||
9006|092|S|artificial tears or other eye lubricants.||
9006|093|S|   To prevent constipation, eat dietary fiber, drink enough||
9006|094|S|water, and exercise. You may also need to take a laxative. Ask||
9006|095|S|your pharmacist which type of laxative is right for you.||
9006|096|S|   Remember that this medication has been prescribed because your||
9006|097|S|doctor has judged that the benefit to you is greater than the||
9006|098|S|risk of side effects. Many people using this medication do not||
9006|099|S|have serious side effects.||
9006|100|S|   Tell your doctor right away if you have any serious side||
9006|101|S|effects, including: decreased sweating, dry/hot/flushed skin,||
9006|102|S|fast/irregular heartbeat, loss of coordination, trouble speaking,||
9006|103|S|fainting, uncontrollable/unusual muscle movements, mental/mood||
9006|104|S|changes (such as confusion, agitation, unusual excitement,||
9006|105|S|depression, strange thoughts), difficulty urinating, decreased||
9006|106|S|sexual ability, signs of infection (such as sore throat that||
9006|107|S|doesn't go away, fever, chills), signs of liver problems (nausea||
9006|108|S|that doesn't stop, dark urine, vomiting, stomach/abdominal pain,||
9006|109|S|yellowing eyes/skin, unusual tiredness).||
9006|110|S|   Get medical help right away if you have any very serious side||
9006|111|S|effects, including: eye pain/swelling/redness, vision changes||
9006|112|S|(such as seeing rainbows around lights at night).||
9006|113|S|   A very serious allergic reaction to this drug is rare.||
9006|114|S|However, get medical help right away if you notice any symptoms||
9006|115|S|of a serious allergic reaction, including: rash, itching/swelling||
9006|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9006|117|S|breathing.||
9006|118|S|   This is not a complete list of possible side effects. If you||
9006|119|S|notice other effects not listed above, contact your doctor or||
9006|120|S|pharmacist.||
9006|121|S|   In the US -||
9006|122|S|   Call your doctor for medical advice about side effects. You||
9006|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9006|124|S|www.fda.gov/medwatch.||
9006|125|S|   In Canada - Call your doctor for medical advice about side||
9006|126|S|effects. You may report side effects to Health Canada at||
9006|127|S|1-866-234-2345.||
9006|128|B|||
9006|129|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9006|130|P|pharmacist if you are allergic to clidinium or chlordiazepoxide;||
9006|131|P|or to other benzodiazepines (such as diazepam, lorazepam); or if||
9006|132|P|you have any other allergies. This product may contain inactive||
9006|133|P|ingredients, which can cause allergic reactions or other||
9006|134|P|problems. Talk to your pharmacist for more details.||
9006|135|P|   Before using this medication, tell your doctor or pharmacist||
9006|136|P|your medical history, especially of: personal or family history||
9006|137|P|of glaucoma (angle-closure type), difficulty urinating (such as||
9006|138|P|due to an enlarged prostate), other stomach/intestinal problems||
9006|139|P|(such as slow gut, blockage, ulcerative colitis, infection,||
9006|140|P|little/no stomach acid, ileostomy/colostomy patients with||
9006|141|P|diarrhea), overactive thyroid, heart problems (such as coronary||
9006|142|P|artery disease, angina, heart failure, fast/irregular heartbeat,||
9006|143|P|heart problems due to severe bleeding), high blood pressure,||
9006|144|P|heartburn problems (such as acid reflux, hiatal hernia, esophagus||
9006|145|P|problems), a certain nervous system problem (autonomic||
9006|146|P|neuropathy), myasthenia gravis, liver problems, kidney problems,||
9006|147|P|breathing/lung problems, personal or family history of a||
9006|148|P|substance use disorder (such as overuse of or addiction to||
9006|149|P|drugs/alcohol), mental/mood conditions (such as depression,||
9006|150|P|thoughts of suicide, psychosis, schizophrenia), a certain blood||
9006|151|P|disorder (porphyria).||
9006|152|P|   This drug may make you dizzy or drowsy or blur your vision.||
9006|153|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9006|154|P|drowsy. Do not drive, use machinery, or do anything that needs||
9006|155|P|alertness or clear vision until you can do it safely. Avoid||
9006|156|P|alcoholic beverages. Talk to your doctor if you are using||
9006|157|P|marijuana (cannabis).||
9006|158|P|   This medication may make you sweat less, making you more||
9006|159|P|likely to get heat stroke. Avoid doing things that may cause you||
9006|160|P|to overheat, such as hard work or exercise in hot weather, or||
9006|161|P|using hot tubs. When the weather is hot, drink a lot of fluids||
9006|162|P|and dress lightly. If you overheat, quickly look for a place to||
9006|163|P|cool down and rest. Get medical help right away if you have a||
9006|164|P|fever that does not go away, mental/mood changes, headache, or||
9006|165|P|dizziness.||
9006|166|P|   Before having surgery, tell your doctor or dentist about all||
9006|167|P|the products you use (including prescription drugs,||
9006|168|P|nonprescription drugs, and herbal products).||
9006|169|P|   Older adults may be more sensitive to the side effects of this||
9006|170|P|drug, especially drowsiness, confusion, unusual excitement,||
9006|171|P|memory problems, constipation, urination problems, and||
9006|172|P|unsteadiness. Drowsiness, confusion, and unsteadiness can||
9006|173|P|increase the risk of falling.||
9006|174|P|   Tell your doctor if you are pregnant or plan to become||
9006|175|P|pregnant. You should not become pregnant while using||
9006|176|P|clidinium/chlordiazepoxide. This medication may harm an unborn||
9006|177|P|baby. Newborn babies of mothers who use this medication late in||
9006|178|P|pregnancy may have symptoms such as slow/shallow breathing,||
9006|179|P|nonstop crying, shaking, or trouble feeding. If you become||
9006|180|P|pregnant, talk to your doctor right away about the risks and||
9006|181|P|benefits of this medication.||
9006|182|P|   This medication passes into breast milk and may have||
9006|183|P|undesirable effects on a nursing infant. Consult your doctor||
9006|184|P|before breastfeeding.||
9006|185|B|||
9006|186|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
9006|187|I|   Drug interactions may change how your medications work or||
9006|188|I|increase your risk for serious side effects. This document does||
9006|189|I|not contain all possible drug interactions. Keep a list of all||
9006|190|I|the products you use (including prescription/nonprescription||
9006|191|I|drugs and herbal products) and share it with your doctor and||
9006|192|I|pharmacist. Do not start, stop, or change the dosage of any||
9006|193|I|medicines without your doctor's approval.||
9006|194|I|   Some products that may interact with this drug include:||
9006|195|I|potassium tablets/capsules, sodium oxybate, drugs that are||
9006|196|I|affected by slowed gut movement (such as pramlintide).||
9006|197|I|   This medication may affect the absorption of other products||
9006|198|I|such as certain azole anti-fungal drugs (ketoconazole,||
9006|199|I|itraconazole), slowly-dissolving forms of digoxin, among others.||
9006|200|I|If you are taking either ketoconazole or itraconazole, take it at||
9006|201|I|least 2 hours before this medication.||
9006|202|I|   Other medications can affect the removal of chlordiazepoxide||
9006|203|I|from your body, which may affect how this drug works. Examples||
9006|204|I|include cimetidine, disulfiram, among others.||
9006|205|I|   Cigarette smoking decreases blood levels of chlordiazepoxide.||
9006|206|I|Tell your doctor if you smoke or if you have recently stopped||
9006|207|I|smoking.||
9006|208|I|   The risk of serious side effects (such as slow/shallow||
9006|209|I|breathing, severe drowsiness/dizziness) may be increased if this||
9006|210|I|medication is taken with other products that may also cause||
9006|211|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
9006|212|I|if you are taking other products such as opioid pain or cough||
9006|213|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9006|214|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9006|215|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9006|216|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
9006|217|I|diphenhydramine).||
9006|218|I|   Check the labels on all your medicines (such as allergy or||
9006|219|I|cough-and-cold products, diet aids) because they may contain||
9006|220|I|ingredients that cause drowsiness or a fast heartbeat. Ask your||
9006|221|I|pharmacist about using those products safely.||
9006|222|I|   This medication may interfere with certain lab tests, possibly||
9006|223|I|causing false test results. Make sure lab personnel and all your||
9006|224|I|doctors know you use this drug.||
9006|225|B|||
9006|226|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9006|227|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9006|228|O|poison control center right away. US residents can call||
9006|229|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9006|230|O|Symptoms of overdose may include: severe drowsiness, hot/dry||
9006|231|O|skin, fever, severe dizziness, severe thirst, mental/mood changes||
9006|232|O|(such as confusion, unusual excitement), fast/irregular||
9006|233|O|heartbeat, muscle weakness, inability to move (paralysis), slowed||
9006|234|O|breathing, fainting, seizures.||
9006|235|B|||
9006|236|N|NOTES:  Do not share this medication with others.||
9006|237|N|   Management of digestive disorders may include lifestyle||
9006|238|N|changes such as stress reduction programs, exercise, stopping||
9006|239|N|smoking, and dietary changes, in addition to medication. Talk to||
9006|240|N|your doctor or pharmacist about lifestyle changes that might||
9006|241|N|benefit you.||
9006|242|N|   If this medication is used for a long time, lab and/or medical||
9006|243|N|tests (such as blood counts, liver function) may be done while||
9006|244|N|you are taking this medication. Keep all medical and lab||
9006|245|N|appointments. Consult your doctor for more details.||
9006|246|B|||
9006|247|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9006|248|D|remember. If it is near the time of the next dose, skip the||
9006|249|D|missed dose. Take your next dose at the regular time. Do not||
9006|250|D|double the dose to catch up.||
9006|251|B|||
9006|252|R|STORAGE:  Store at room temperature away from light and moisture.||
9006|253|R|Do not store in the bathroom. Keep all medications away from||
9006|254|R|children and pets.||
9006|255|R|   Do not flush medications down the toilet or pour them into a||
9006|256|R|drain unless instructed to do so. Properly discard this product||
9006|257|R|when it is expired or no longer needed. Consult your pharmacist||
9006|258|R|or local waste disposal company.||
9006|259|B|||
9006|260|A|Information last revised May 2025.||
9006|261|A|Copyright(c) 2025 First Databank, Inc.||
9006|262|B|||
9007|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9007|002|Z|does NOT have all possible information about this product. This||
9007|003|Z|information does not assure that this product is safe, effective,||
9007|004|Z|or appropriate for you. This information is not individual||
9007|005|Z|medical advice and does not substitute for the advice of your||
9007|006|Z|health care professional. Always ask your health care||
9007|007|Z|professional for complete information about this product and your||
9007|008|Z|specific health needs.||
9007|009|B|||
9007|010|T|DANAZOL - ORAL||
9007|011|F|(DAY-nuh-zole)||
9007|012|B|||
9007|013|C|COMMON BRAND NAME(S): Danocrine||
9007|014|B|||
9007|015|W|WARNING:  This medication must not be used during pregnancy. It||
9007|016|W|may harm an unborn baby. In women of childbearing age, this||
9007|017|W|medication should be started during their menstrual period. If||
9007|018|W|not, then they should have a negative pregnancy test before||
9007|019|W|starting this medication. It is important to prevent pregnancy||
9007|020|W|while using this medication. Consult your doctor for more details||
9007|021|W|and to discuss the use reliable forms of non-hormonal birth||
9007|022|W|control (such as condoms, diaphragm with spermicide) while using||
9007|023|W|this medication. If you become pregnant or think you may be||
9007|024|W|pregnant, tell your doctor right away.||
9007|025|W|   Danazol has rarely caused very serious (possibly fatal) blood||
9007|026|W|clots (such as stroke), liver disease, and increased pressure on||
9007|027|W|the brain (benign intracranial hypertension). Get medical help||
9007|028|W|right away if you have any symptoms of these side effects,||
9007|029|W|including nausea/vomiting that doesn't stop, headache that is||
9007|030|W|severe or doesn't go away, weakness on one side of the body,||
9007|031|W|trouble speaking, vision changes, severe stomach/abdominal pain,||
9007|032|W|dark urine, yellowing eyes/skin, mental/mood changes (such as||
9007|033|W|confusion).||
9007|034|B|||
9007|035|U|USES:  This medication is used in women to treat pelvic pain and||
9007|036|U|infertility due to a certain disorder (endometriosis) and also to||
9007|037|U|treat breast pain/tenderness/nodules due to a certain breast||
9007|038|U|condition (fibrocystic breast disease). It is also used in both||
9007|039|U|men and women to prevent swelling of the||
9007|040|U|abdomen/arms/legs/face/airway due to a certain congenital disease||
9007|041|U|(hereditary angioedema).||
9007|042|U|   Danazol is an androgen similar to testosterone. For the||
9007|043|U|treatment of endometriosis and fibrocystic breast disease, it||
9007|044|U|works by decreasing the amount of hormones made by the ovaries.||
9007|045|U|These hormones usually make the conditions worse. For the||
9007|046|U|treatment of angioedema, danazol helps to increase the amount of||
9007|047|U|a certain protein in your body's defense system (immune system).||
9007|048|B|||
9007|049|H|HOW TO USE:  Take this medication by mouth as directed by your||
9007|050|H|doctor, usually twice daily. You may take this medication with or||
9007|051|H|without food, but it is important to choose one way and take this||
9007|052|H|medication the same way with every dose.||
9007|053|H|   The dosage is based on your medical condition and response to||
9007|054|H|treatment.||
9007|055|H|   Use this medication regularly to get the most benefit from it.||
9007|056|H|To help you remember, take it at the same times each day.||
9007|057|H|   Tell your doctor if your condition does not get better or if||
9007|058|H|it gets worse.||
9007|059|B|||
9007|060|S|SIDE EFFECTS:  See also Warning section.||
9007|061|S|   Weight gain, acne, flushing, sweating, voice changes||
9007|062|S|(hoarseness, change in pitch), abnormal growth of body hair (in||
9007|063|S|women), vaginal dryness/irritation, or decreased breast size may||
9007|064|S|occur. If any of these effects last or get worse, tell your||
9007|065|S|doctor or pharmacist promptly.||
9007|066|S|   Remember that this medication has been prescribed because your||
9007|067|S|doctor has judged that the benefit to you is greater than the||
9007|068|S|risk of side effects. Many people using this medication do not||
9007|069|S|have serious side effects.||
9007|070|S|   Tell your doctor right away if you have any serious side||
9007|071|S|effects, including: swelling hands/ankles/feet, menstrual changes||
9007|072|S|(such as spotting, missed periods), mental/mood changes (such as||
9007|073|S|nervousness, mood swings).||
9007|074|S|   A very serious allergic reaction to this drug is rare.||
9007|075|S|However, get medical help right away if you notice any symptoms||
9007|076|S|of a serious allergic reaction, including: rash, itching/swelling||
9007|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9007|078|S|breathing.||
9007|079|S|   This is not a complete list of possible side effects. If you||
9007|080|S|notice other effects not listed above, contact your doctor or||
9007|081|S|pharmacist.||
9007|082|S|   In the US -||
9007|083|S|   Call your doctor for medical advice about side effects. You||
9007|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9007|085|S|www.fda.gov/medwatch.||
9007|086|S|   In Canada - Call your doctor for medical advice about side||
9007|087|S|effects. You may report side effects to Health Canada at||
9007|088|S|1-866-234-2345.||
9007|089|B|||
9007|090|P|PRECAUTIONS:  Before taking danazol, tell your doctor or||
9007|091|P|pharmacist if you are allergic to it; or if you have any other||
9007|092|P|allergies. This product may contain inactive ingredients, which||
9007|093|P|can cause allergic reactions or other problems. Talk to your||
9007|094|P|pharmacist for more details.||
9007|095|P|   Before using this medication, tell your doctor or pharmacist||
9007|096|P|your medical history, especially of: heart/blood vessel disease||
9007|097|P|(such as coronary artery disease, stroke), high blood pressure||
9007|098|P|(hypertension), diabetes, high cholesterol levels, breast cancer,||
9007|099|P|liver disease, kidney disease, seizures, migraine headaches,||
9007|100|P|unusual vaginal bleeding, certain blood disorders (porphyria,||
9007|101|P|polycythemia), prostate cancer.||
9007|102|P|   Before having surgery, tell your doctor or dentist about all||
9007|103|P|the products you use (including prescription drugs,||
9007|104|P|nonprescription drugs, and herbal products).||
9007|105|P|   This medication may affect the sperm. Consult your doctor for||
9007|106|P|more details.||
9007|107|P|   This medication must not be used during pregnancy. It may harm||
9007|108|P|the unborn baby. If you become pregnant or think you may be||
9007|109|P|pregnant, tell your doctor right away. (See also Warning||
9007|110|P|section.)||
9007|111|P|   It is unknown if this medication passes into breast milk.||
9007|112|P|Because of the possible risk to the infant, breastfeeding is not||
9007|113|P|recommended while using this medication. Consult your doctor||
9007|114|P|before breastfeeding.||
9007|115|B|||
9007|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9007|117|I|medications work or increase your risk for serious side effects.||
9007|118|I|This document does not contain all possible drug interactions.||
9007|119|I|Keep a list of all the products you use (including||
9007|120|I|prescription/nonprescription drugs and herbal products) and share||
9007|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
9007|122|I|the dosage of any medicines without your doctor's approval.||
9007|123|I|   Some products that may interact with this drug include: "blood||
9007|124|I|thinners" (such as warfarin), certain "statin" cholesterol||
9007|125|I|medications (lovastatin, simvastatin).||
9007|126|I|   This medication may interfere with certain lab tests (such as||
9007|127|I|testosterone levels), possibly causing false test results. Make||
9007|128|I|sure lab personnel and all your doctors know you use this drug.||
9007|129|B|||
9007|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9007|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9007|132|O|poison control center right away. US residents can call||
9007|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9007|134|O|Symptoms of overdose may include: yellowing eyes/skin, severe||
9007|135|O|stomach/abdominal pain, dark urine.||
9007|136|B|||
9007|137|N|NOTES:  Do not share this medication with others.||
9007|138|N|   Lab and/or medical tests (such as liver function, cholesterol||
9007|139|N|levels) should be done while you are taking this medication. Keep||
9007|140|N|all medical and lab appointments. Consult your doctor for more||
9007|141|N|details.||
9007|142|B|||
9007|143|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9007|144|D|remember. If it is near the time of the next dose, skip the||
9007|145|D|missed dose. Take your next dose at the regular time. Do not||
9007|146|D|double the dose to catch up.||
9007|147|B|||
9007|148|R|STORAGE:  Store at room temperature away from light and moisture.||
9007|149|R|Do not store in the bathroom. Keep all medications away from||
9007|150|R|children and pets.||
9007|151|R|   Do not flush medications down the toilet or pour them into a||
9007|152|R|drain unless instructed to do so. Properly discard this product||
9007|153|R|when it is expired or no longer needed. Consult your pharmacist||
9007|154|R|or local waste disposal company.||
9007|155|B|||
9007|156|A|Information last revised October 2024.||
9007|157|A|Copyright(c) 2025 First Databank, Inc.||
9007|158|B|||
9009|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9009|002|Z|does NOT have all possible information about this product. This||
9009|003|Z|information does not assure that this product is safe, effective,||
9009|004|Z|or appropriate for you. This information is not individual||
9009|005|Z|medical advice and does not substitute for the advice of your||
9009|006|Z|health care professional. Always ask your health care||
9009|007|Z|professional for complete information about this product and your||
9009|008|Z|specific health needs.||
9009|009|B|||
9009|010|T|ACETAMINOPHEN SUPPOSITORY - RECTAL||
9009|011|F|(a-SEET-a-MIN-oh-fen)||
9009|012|B|||
9009|013|C|COMMON BRAND NAME(S): Acephen, Feverall||
9009|014|B|||
9009|015|W|WARNING:  Taking too much acetaminophen may cause serious||
9009|016|W|(possibly fatal) liver disease. Adults should not take more than||
9009|017|W|4000 milligrams (4 grams) of acetaminophen a day. People with||
9009|018|W|liver problems and children should take less acetaminophen. Ask||
9009|019|W|your doctor or pharmacist how much acetaminophen is safe to take.||
9009|020|W|   Do not use with any other drug containing acetaminophen||
9009|021|W|without asking your doctor or pharmacist first. Acetaminophen is||
9009|022|W|in many nonprescription and prescription medications (such as||
9009|023|W|pain/fever drugs or cough-and-cold products). Check the labels on||
9009|024|W|all your medicines to see if they contain acetaminophen, and ask||
9009|025|W|your pharmacist if you are unsure.||
9009|026|W|   Get medical help right away if you take too much acetaminophen||
9009|027|W|(overdose), even if you feel well. Overdose symptoms may include||
9009|028|W|nausea, vomiting, loss of appetite, sweating, stomach/abdominal||
9009|029|W|pain, extreme tiredness, yellowing eyes/skin, and dark urine.||
9009|030|W|   Daily alcohol use, especially when combined with||
9009|031|W|acetaminophen, may damage your liver. Avoid alcohol.||
9009|032|B|||
9009|033|U|USES:  This drug is used to treat mild to moderate pain (from||
9009|034|U|headaches, menstrual periods, toothaches, backaches,||
9009|035|U|osteoarthritis, or cold/flu aches and pains) and to reduce fever.||
9009|036|B|||
9009|037|H|HOW TO USE:  See also Warning section.||
9009|038|H|   Use this product rectally as directed. Follow all directions||
9009|039|H|on the product package. If you have any questions, ask your||
9009|040|H|doctor or pharmacist.||
9009|041|H|   If you are giving acetaminophen to a child, be sure you use a||
9009|042|H|product that is meant for children. Use your child's age (or||
9009|043|H|weight) to find the right dose on the product package.||
9009|044|H|   First, unwrap 1 suppository. Lie down on your left side with||
9009|045|H|right knee bent. If giving to a child, the child may lie on the||
9009|046|H|side or flat on the back. Gently push the suppository into the||
9009|047|H|rectum with your finger. After inserting the suppository, if||
9009|048|H|necessary, hold the buttocks together for 30 to 60 seconds to||
9009|049|H|keep the suppository in place. Remain lying down for a few||
9009|050|H|minutes, and avoid having a bowel movement for an hour or longer||
9009|051|H|so the drug will be absorbed. The suppository is for rectal use||
9009|052|H|only.||
9009|053|H|   Pain medications work best if they are used as the first signs||
9009|054|H|of pain occur. If you wait until the symptoms have worsened, the||
9009|055|H|medication may not work as well.||
9009|056|H|   Do not use more than recommended. Do not use this medication||
9009|057|H|for fever for more than 3 days unless directed by your doctor.||
9009|058|H|For adults, do not use this product for pain for more than 10||
9009|059|H|days (5 days in children) unless directed by your doctor. If the||
9009|060|H|child has a sore throat (especially with high fever, headache, or||
9009|061|H|nausea/vomiting), consult the doctor promptly.||
9009|062|H|   Tell your doctor if your condition lasts or gets worse or if||
9009|063|H|you develop new symptoms. If you think you may have a serious||
9009|064|H|medical problem, get medical help right away.||
9009|065|B|||
9009|066|S|SIDE EFFECTS:  See also Warning section.||
9009|067|S|   This drug usually has no side effects. If you have any unusual||
9009|068|S|effects, contact your doctor or pharmacist promptly.||
9009|069|S|   If your doctor has directed you to use this medication,||
9009|070|S|remember that your doctor has judged that the benefit to you is||
9009|071|S|greater than the risk of side effects. Many people using this||
9009|072|S|medication do not have serious side effects.||
9009|073|S|   A very serious allergic reaction to this drug is rare.||
9009|074|S|However, get medical help right away if you notice any symptoms||
9009|075|S|of a serious allergic reaction, including: rash, itching/swelling||
9009|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9009|077|S|breathing.||
9009|078|S|   This is not a complete list of possible side effects. If you||
9009|079|S|notice other effects not listed above, contact your doctor or||
9009|080|S|pharmacist.||
9009|081|S|   In the US -||
9009|082|S|   Call your doctor for medical advice about side effects. You||
9009|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9009|084|S|www.fda.gov/medwatch.||
9009|085|S|   In Canada - Call your doctor for medical advice about side||
9009|086|S|effects. You may report side effects to Health Canada at||
9009|087|S|1-866-234-2345.||
9009|088|B|||
9009|089|P|PRECAUTIONS:  See also Warning section.||
9009|090|P|   Before using acetaminophen, tell your doctor or pharmacist if||
9009|091|P|you are allergic to it; or if you have any other allergies. This||
9009|092|P|product may contain inactive ingredients, which can cause||
9009|093|P|allergic reactions or other problems. Talk to your pharmacist for||
9009|094|P|more details.||
9009|095|P|   Before using this product, tell your doctor or pharmacist your||
9009|096|P|medical history, especially of: liver disease, regular use/abuse||
9009|097|P|of alcohol.||
9009|098|P|   Tell your doctor if you are pregnant before using this||
9009|099|P|medication.||
9009|100|P|   Acetaminophen passes into breast milk. Consult your doctor||
9009|101|P|before breastfeeding.||
9009|102|B|||
9009|103|I|DRUG INTERACTIONS:  See also Warning section.||
9009|104|I|   Drug interactions may change how your medications work or||
9009|105|I|increase your risk for serious side effects. This document does||
9009|106|I|not contain all possible drug interactions. Keep a list of all||
9009|107|I|the products you use (including prescription/nonprescription||
9009|108|I|drugs and herbal products) and share it with your doctor and||
9009|109|I|pharmacist. Do not start, stop, or change the dosage of any||
9009|110|I|medicines without your doctor's approval.||
9009|111|I|   Some products that may interact with this drug are:||
9009|112|I|ketoconazole, levoketoconazole.||
9009|113|I|   This medication may interfere with certain lab tests, possibly||
9009|114|I|causing false test results. Make sure lab personnel and all your||
9009|115|I|doctors know you use this drug.||
9009|116|B|||
9009|117|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9009|118|O|has overdosed and has serious symptoms such as passing out or||
9009|119|O|trouble breathing, call 911. Otherwise, call a poison control||
9009|120|O|center right away. US residents can call 1-800-222-1222. Canada||
9009|121|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9009|122|O|include: nausea, vomiting, loss of appetite, sweating,||
9009|123|O|stomach/abdominal pain, extreme tiredness, yellowing eyes/skin,||
9009|124|O|dark urine.||
9009|125|B|||
9009|126|N|NOTES:  Acetaminophen does not cause the stomach and intestinal||
9009|127|N|ulcers that NSAIDs such as aspirin, ibuprofen, and naproxen may||
9009|128|N|cause. However, acetaminophen does not reduce swelling||
9009|129|N|(inflammation) like the NSAIDs do. Consult your doctor for more||
9009|130|N|details and to see which medication might be right for you.||
9009|131|B|||
9009|132|D|MISSED DOSE:  If you are using this medication on a regular basis||
9009|133|D|and miss a dose, use it as soon as you remember. If it is near||
9009|134|D|the time of the next dose, skip the missed dose. Use your next||
9009|135|D|dose at the regular time. Do not double the dose to catch up.||
9009|136|B|||
9009|137|R|STORAGE:  Store at room temperature away from heat. Certain||
9009|138|R|brands may also be stored in the refrigerator. Do not freeze.||
9009|139|R|Check the product package for instructions on how to store your||
9009|140|R|brand, or ask your pharmacist. Keep all medications away from||
9009|141|R|children and pets.||
9009|142|R|   Do not flush medications down the toilet or pour them into a||
9009|143|R|drain unless instructed to do so. Properly discard this product||
9009|144|R|when it is expired or no longer needed. Consult your pharmacist||
9009|145|R|or local waste disposal company.||
9009|146|B|||
9009|147|A|Information last revised September 2024.||
9009|148|A|Copyright(c) 2025 First Databank, Inc.||
9009|149|B|||
9010|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9010|002|Z|does NOT have all possible information about this product. This||
9010|003|Z|information does not assure that this product is safe, effective,||
9010|004|Z|or appropriate for you. This information is not individual||
9010|005|Z|medical advice and does not substitute for the advice of your||
9010|006|Z|health care professional. Always ask your health care||
9010|007|Z|professional for complete information about this product and your||
9010|008|Z|specific health needs.||
9010|009|B|||
9010|010|T|AMLODIPINE - ORAL||
9010|011|F|(am-LOE-di-peen)||
9010|012|B|||
9010|013|C|COMMON BRAND NAME(S): Norvasc||
9010|014|B|||
9010|015|U|USES:  Amlodipine is used with or without other medications to||
9010|016|U|treat high blood pressure. Lowering high blood pressure helps||
9010|017|U|prevent strokes, heart attacks, and kidney problems. Amlodipine||
9010|018|U|belongs to a class of drugs known as calcium channel blockers. It||
9010|019|U|works by relaxing blood vessels so blood can flow more easily.||
9010|020|U|   Amlodipine is also used to prevent certain types of chest pain||
9010|021|U|(angina). It may help to increase your ability to exercise and||
9010|022|U|decrease the frequency of angina attacks. It should not be used||
9010|023|U|to treat attacks of chest pain when they occur. Use other||
9010|024|U|medications (such as sublingual nitroglycerin) to relieve attacks||
9010|025|U|of chest pain as directed by your doctor.||
9010|026|B|||
9010|027|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9010|028|H|from your pharmacist before you start taking amlodipine and each||
9010|029|H|time you get a refill. If you have any questions, ask your doctor||
9010|030|H|or pharmacist.||
9010|031|H|   Take this medication by mouth with or without food as directed||
9010|032|H|by your doctor, usually once daily.||
9010|033|H|   If you are using the liquid form of this medication, check the||
9010|034|H|manufacturer's information or ask your pharmacist for specific||
9010|035|H|directions. Some brands of the liquid form should be shaken||
9010|036|H|before use, while other brands do not need to be shaken before||
9010|037|H|use. Carefully measure the dose using a special measuring||
9010|038|H|device/spoon. Do not use a household spoon because you may not||
9010|039|H|get the correct dose||
9010|040|H|   The dosage is based on your medical condition and response to||
9010|041|H|treatment. Your doctor may gradually increase your dose. Follow||
9010|042|H|your doctor's instructions carefully.||
9010|043|H|   Use this medication regularly to get the most benefit from it.||
9010|044|H|To help you remember, take it at the same time each day. Keep||
9010|045|H|taking this medication even if you feel well. Most people with||
9010|046|H|high blood pressure do not feel sick.||
9010|047|H|   If used for angina, this medication must be taken regularly to||
9010|048|H|be effective. It should not be used to treat angina when it||
9010|049|H|occurs. Use other medications (such as sublingual nitroglycerin)||
9010|050|H|to relieve an angina attack as directed by your doctor. Consult||
9010|051|H|your doctor or pharmacist for details.||
9010|052|H|   Tell your doctor if your condition does not get better or if||
9010|053|H|it gets worse (for example, your blood pressure readings remain||
9010|054|H|high or increase, chest pain continues or worsens).||
9010|055|B|||
9010|056|S|SIDE EFFECTS:  Dizziness, lightheadedness, swelling ankles/feet,||
9010|057|S|or flushing may occur. If any of these effects last or get worse,||
9010|058|S|tell your doctor or pharmacist promptly.||
9010|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
9010|060|S|slowly when rising from a sitting or lying position.||
9010|061|S|   Remember that this medication has been prescribed because your||
9010|062|S|doctor has judged that the benefit to you is greater than the||
9010|063|S|risk of side effects. Many people using this medication do not||
9010|064|S|have serious side effects.||
9010|065|S|   Tell your doctor right away if you have any serious side||
9010|066|S|effects, including: fast/irregular/pounding heartbeat, fainting.||
9010|067|S|   Although this medication is effective in preventing chest pain||
9010|068|S|(angina), some people who already have severe heart disease may||
9010|069|S|rarely develop worsening chest pain or a heart attack after||
9010|070|S|starting this medication or increasing the dose. Get medical help||
9010|071|S|right away if you experience: worsening chest pain, symptoms of a||
9010|072|S|heart attack (such as chest/jaw/left arm pain, shortness of||
9010|073|S|breath, unusual sweating).||
9010|074|S|   A very serious allergic reaction to this drug is rare.||
9010|075|S|However, get medical help right away if you notice any symptoms||
9010|076|S|of a serious allergic reaction, including: rash, itching/swelling||
9010|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9010|078|S|breathing.||
9010|079|S|   This is not a complete list of possible side effects. If you||
9010|080|S|notice other effects not listed above, contact your doctor or||
9010|081|S|pharmacist.||
9010|082|S|   In the US -||
9010|083|S|   Call your doctor for medical advice about side effects. You||
9010|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9010|085|S|www.fda.gov/medwatch.||
9010|086|S|   In Canada - Call your doctor for medical advice about side||
9010|087|S|effects. You may report side effects to Health Canada at||
9010|088|S|1-866-234-2345.||
9010|089|B|||
9010|090|P|PRECAUTIONS:  Before taking amlodipine, tell your doctor or||
9010|091|P|pharmacist if you are allergic to it; or to other dihydropyridine||
9010|092|P|calcium channel blockers (such as nisoldipine, nifedipine) or if||
9010|093|P|you have any other allergies. This product may contain inactive||
9010|094|P|ingredients, which can cause allergic reactions or other||
9010|095|P|problems. Talk to your pharmacist for more details.||
9010|096|P|   Before using this medication, tell your doctor or pharmacist||
9010|097|P|your medical history, especially of: a certain structural heart||
9010|098|P|problem (aortic stenosis), very low blood pressure, liver||
9010|099|P|disease.||
9010|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9010|101|P|can make you more dizzy. Do not drive, use machinery, or do||
9010|102|P|anything that needs alertness until you can do it safely. Limit||
9010|103|P|alcoholic beverages. Talk to your doctor if you are using||
9010|104|P|marijuana (cannabis).||
9010|105|P|   Before having surgery, tell your doctor or dentist about all||
9010|106|P|the products you use (including prescription drugs,||
9010|107|P|nonprescription drugs, and herbal products).||
9010|108|P|   Older adults may be more sensitive to the effects of this||
9010|109|P|drug, especially dizziness.||
9010|110|P|   During pregnancy, this medication should be used only when||
9010|111|P|clearly needed. Discuss the risks and benefits with your doctor.||
9010|112|P|   This drug passes into breast milk. Consult your doctor before||
9010|113|P|breastfeeding.||
9010|114|B|||
9010|115|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9010|116|I|medications work or increase your risk for serious side effects.||
9010|117|I|This document does not contain all possible drug interactions.||
9010|118|I|Keep a list of all the products you use (including||
9010|119|I|prescription/nonprescription drugs and herbal products) and share||
9010|120|I|it with your doctor and pharmacist. Do not start, stop, or change||
9010|121|I|the dosage of any medicines without your doctor's approval.||
9010|122|I|   Some products have ingredients that could raise your blood||
9010|123|I|pressure. Tell your pharmacist what products you are using, and||
9010|124|I|ask how to use them safely (especially cough-and-cold products,||
9010|125|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
9010|126|B|||
9010|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9010|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9010|129|O|poison control center right away. US residents can call||
9010|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9010|131|O|Symptoms of overdose may include: fainting, severe dizziness.||
9010|132|B|||
9010|133|N|NOTES:  Do not share this medication with others.||
9010|134|N|   Lifestyle changes that may help this medication work better||
9010|135|N|include exercising, stopping smoking, reducing stress, and eating||
9010|136|N|a low-cholesterol/low-fat diet. Consult your doctor for more||
9010|137|N|details.||
9010|138|N|   Lab and/or medical tests (such as blood pressure) should be||
9010|139|N|done while you are taking this medication. Keep all medical and||
9010|140|N|lab appointments. Consult your doctor for more details.||
9010|141|N|   Check your blood pressure regularly while taking this||
9010|142|N|medication. Learn how to monitor your own blood pressure at home,||
9010|143|N|and share the results with your doctor.||
9010|144|B|||
9010|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9010|146|D|remember. If it is near the time of the next dose, skip the||
9010|147|D|missed dose. Take your next dose at the regular time. Do not||
9010|148|D|double the dose to catch up.||
9010|149|B|||
9010|150|R|STORAGE:  Store the tablets at room temperature away from light||
9010|151|R|and moisture. Do not store in the bathroom. Keep all medications||
9010|152|R|away from children and pets.||
9010|153|R|   Different brands of the liquid form of this medication have||
9010|154|R|different storage needs. Check the product package for||
9010|155|R|instructions on how to store your brand, or ask your pharmacist.||
9010|156|R|   Do not flush medications down the toilet or pour them into a||
9010|157|R|drain unless instructed to do so. Properly discard this product||
9010|158|R|when it is expired or no longer needed. Consult your pharmacist||
9010|159|R|or local waste disposal company.||
9010|160|B|||
9010|161|A|Information last revised May 2024.||
9010|162|A|Copyright(c) 2025 First Databank, Inc.||
9010|163|B|||
9012|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9012|002|Z|does NOT have all possible information about this product. This||
9012|003|Z|information does not assure that this product is safe, effective,||
9012|004|Z|or appropriate for you. This information is not individual||
9012|005|Z|medical advice and does not substitute for the advice of your||
9012|006|Z|health care professional. Always ask your health care||
9012|007|Z|professional for complete information about this product and your||
9012|008|Z|specific health needs.||
9012|009|B|||
9012|010|T|ANTIHISTAMINES/DECONGESTANTS - ORAL||
9012|011|B|||
9012|012|U|USES:  This combination medication is used to temporarily relieve||
9012|013|U|symptoms caused by the common cold, flu, allergies, or other||
9012|014|U|breathing illnesses (such as sinusitis, bronchitis).||
9012|015|U|Antihistamines help relieve watery eyes, itchy eyes/nose/throat,||
9012|016|U|runny nose, and sneezing. Decongestants help to relieve stuffy||
9012|017|U|nose and ear congestion symptoms.||
9012|018|U|   If you are self-treating with this medication, carefully read||
9012|019|U|the package instructions to be sure it is right for you before||
9012|020|U|you start using this product. Some products have similar brand||
9012|021|U|names but different active ingredients with different uses.||
9012|022|U|Taking the wrong product could harm you. Ask your pharmacist if||
9012|023|U|you have any questions about your product or its use.||
9012|024|U|   Cough-and-cold products have not been shown to be safe or||
9012|025|U|effective in children younger than 6 years. Do not use this||
9012|026|U|product to treat cold symptoms in children younger than 6 years||
9012|027|U|unless specifically directed by the doctor. Some products||
9012|028|U|(including some long-acting tablets/capsules) are not recommended||
9012|029|U|for use in children younger than 12 years. Ask your doctor or||
9012|030|U|pharmacist for more details about using your product safely. Do||
9012|031|U|not use this product to make a child sleepy.||
9012|032|U|   These products do not cure or shorten the length of the common||
9012|033|U|cold and may cause serious side effects. To decrease the risk for||
9012|034|U|serious side effects, carefully follow all dosage directions. Do||
9012|035|U|not give other cough-and-cold medication that might contain the||
9012|036|U|same or similar ingredients (see also Drug Interactions section).||
9012|037|U|Ask the doctor or pharmacist about other ways to relieve cough||
9012|038|U|and cold symptoms (such as drinking enough fluids, using a||
9012|039|U|humidifier or saline nose drops/spray).||
9012|040|B|||
9012|041|H|HOW TO USE:  Take this medication by mouth as directed by your||
9012|042|H|doctor. If you are self-treating, follow all directions on the||
9012|043|H|product package. If you have any questions, ask your doctor or||
9012|044|H|pharmacist.||
9012|045|H|   This medication may be taken with food if stomach upset||
9012|046|H|occurs. Drink plenty of fluids unless otherwise directed by your||
9012|047|H|doctor.||
9012|048|H|   If you are using the liquid form of this medication, carefully||
9012|049|H|measure the dose using a special measuring device/spoon. Do not||
9012|050|H|use a household spoon because you may not get the correct dose.||
9012|051|H|If your liquid form is a suspension, shake the bottle well before||
9012|052|H|each dose.||
9012|053|H|   Do not crush or chew extended-release tablets or capsules.||
9012|054|H|Doing so can release all of the drug at once, increasing the risk||
9012|055|H|of side effects. Also, do not split extended-release tablets||
9012|056|H|unless they have a score line and your doctor or pharmacist tells||
9012|057|H|you to do so. Swallow the whole or split tablet without crushing||
9012|058|H|or chewing.||
9012|059|H|   If you are using chewable tablets, chew each tablet thoroughly||
9012|060|H|before swallowing.||
9012|061|H|   If you are using a product made to dissolve in the mouth||
9012|062|H|(tablets/strips), dry your hands before handling the medication.||
9012|063|H|Place each dose on the tongue and allow to dissolve completely,||
9012|064|H|then swallow it with saliva or with water.||
9012|065|H|   The dosage is based on the product you are taking and your||
9012|066|H|age, medical condition, and response to treatment. Do not||
9012|067|H|increase your dose or take this medication more often than||
9012|068|H|directed without your doctor's approval. Improper use (abuse) of||
9012|069|H|this medication may result in serious harm (such as||
9012|070|H|hallucinations, seizure, death).||
9012|071|H|   If your doctor directs you to take this medication daily, take||
9012|072|H|it regularly to get the most benefit from it. To help you||
9012|073|H|remember, take it at the same time(s) each day.||
9012|074|H|   Tell your doctor if your condition lasts for more than 1 week,||
9012|075|H|if it gets worse, or if it occurs with a headache that doesn't go||
9012|076|H|away, fever, or rash. These may be symptoms of a serious medical||
9012|077|H|problem and should be checked by a doctor.||
9012|078|B|||
9012|079|S|SIDE EFFECTS:  Drowsiness, dizziness, dry mouth/nose/throat,||
9012|080|S|headache, upset stomach, constipation, or trouble sleeping may||
9012|081|S|occur. If any of these effects last or get worse, tell your||
9012|082|S|doctor or pharmacist promptly.||
9012|083|S|   If your doctor has directed you to use this product, remember||
9012|084|S|that your doctor has judged that the benefit to you is greater||
9012|085|S|than the risk of side effects. Many people using this product do||
9012|086|S|not have serious side effects.||
9012|087|S|   This medication may raise your blood pressure. Check your||
9012|088|S|blood pressure regularly and tell your doctor if the results are||
9012|089|S|high.||
9012|090|S|   Tell your doctor right away if you have any serious side||
9012|091|S|effects, including: mental/mood changes (such as confusion,||
9012|092|S|hallucinations), ringing in the ears, difficulty urinating,||
9012|093|S|vision changes (such as blurred/double vision).||
9012|094|S|   Get medical help right away if you have any very serious side||
9012|095|S|effects, including: fast/irregular heartbeat, seizure.||
9012|096|S|   A very serious allergic reaction to this drug is rare.||
9012|097|S|However, get medical help right away if you notice any symptoms||
9012|098|S|of a serious allergic reaction, including: rash, itching/swelling||
9012|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9012|100|S|breathing.||
9012|101|S|   This is not a complete list of possible side effects. If you||
9012|102|S|notice other effects not listed above, contact your doctor or||
9012|103|S|pharmacist.||
9012|104|S|   In the US -||
9012|105|S|   Call your doctor for medical advice about side effects. You||
9012|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9012|107|S|www.fda.gov/medwatch.||
9012|108|S|   In Canada - Call your doctor for medical advice about side||
9012|109|S|effects. You may report side effects to Health Canada at||
9012|110|S|1-866-234-2345.||
9012|111|B|||
9012|112|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
9012|113|P|pharmacist if you are allergic to any of its ingredients; or if||
9012|114|P|you have any other allergies. This product may contain inactive||
9012|115|P|ingredients, which can cause allergic reactions or other||
9012|116|P|problems. Talk to your pharmacist for more details.||
9012|117|P|   Before using this medication, tell your doctor or pharmacist||
9012|118|P|your medical history, especially of: breathing problems (such as||
9012|119|P|asthma, emphysema), diabetes, glaucoma, heart problems, high||
9012|120|P|blood pressure, kidney problems, liver disease, seizures,||
9012|121|P|stomach/intestinal problems (such as ulcers, blockage),||
9012|122|P|overactive thyroid (hyperthyroidism), difficulty urinating (such||
9012|123|P|as due to enlarged prostate).||
9012|124|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9012|125|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9012|126|P|machinery, or do anything that needs alertness until you can do||
9012|127|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9012|128|P|are using marijuana (cannabis).||
9012|129|P|   Liquid products, chewable tablets, or dissolving||
9012|130|P|tablets/strips may contain sugar or aspartame. Liquid products||
9012|131|P|may also contain alcohol. Caution is advised if you have||
9012|132|P|diabetes, alcohol dependence, liver disease, phenylketonuria||
9012|133|P|(PKU), or any other condition that requires you to limit/avoid||
9012|134|P|these substances in your diet. Ask your doctor or pharmacist||
9012|135|P|about using this product safely.||
9012|136|P|   Before having surgery, tell your doctor or dentist about all||
9012|137|P|the products you use (including prescription drugs,||
9012|138|P|nonprescription drugs, and herbal products).||
9012|139|P|   Children may be more sensitive to the side effects of this||
9012|140|P|product, especially excitation and agitation.||
9012|141|P|   Older adults may be more sensitive to the side effects of this||
9012|142|P|product, especially dizziness, drowsiness, confusion,||
9012|143|P|constipation, fast/irregular heartbeat, trouble sleeping, or||
9012|144|P|urination problems. Dizziness, drowsiness, trouble sleeping, and||
9012|145|P|confusion can increase the risk of falling.||
9012|146|P|   During pregnancy, this medication should be used only when||
9012|147|P|clearly needed. Discuss the risks and benefits with your doctor.||
9012|148|P|   This medication may pass into breast milk and the effect on a||
9012|149|P|nursing infant is unknown. Consult your doctor before||
9012|150|P|breastfeeding.||
9012|151|B|||
9012|152|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9012|153|I|medications work or increase your risk for serious side effects.||
9012|154|I|This document does not contain all possible drug interactions.||
9012|155|I|Keep a list of all the products you use (including||
9012|156|I|prescription/nonprescription drugs and herbal products) and share||
9012|157|I|it with your doctor and pharmacist. Do not start, stop, or change||
9012|158|I|the dosage of any medicines without your doctor's approval.||
9012|159|I|   Some products that may interact with this drug are:||
9012|160|I|antihistamines applied to the skin (such as diphenhydramine||
9012|161|I|cream, ointment, spray).||
9012|162|I|   Taking MAO inhibitors with this medication may cause a serious||
9012|163|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9012|164|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9012|165|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9012|166|I|selegiline, tranylcypromine) during treatment with this||
9012|167|I|medication. Most MAO inhibitors should also not be taken for two||
9012|168|I|weeks before treatment with this medication. Ask your doctor when||
9012|169|I|to start or stop taking this medication.||
9012|170|I|   Tell your doctor or pharmacist if you are taking other||
9012|171|I|products that cause drowsiness such as opioid pain or cough||
9012|172|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9012|173|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9012|174|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9012|175|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
9012|176|I|diphenhydramine).||
9012|177|I|   Check the labels on all your medicines (such as allergy or||
9012|178|I|cough-and-cold products) because they may contain ingredients||
9012|179|I|that cause drowsiness. Ask your pharmacist about using those||
9012|180|I|products safely.||
9012|181|I|   This medication may interfere with certain medical/lab tests||
9012|182|I|(such as brain scan for Parkinson's disease, urine drug screening||
9012|183|I|tests, allergy skin test), possibly causing false test results.||
9012|184|I|Make sure lab personnel and all your doctors know you use this||
9012|185|I|drug.||
9012|186|B|||
9012|187|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9012|188|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9012|189|O|poison control center right away. US residents can call||
9012|190|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9012|191|O|Symptoms of overdose may include: irregular heartbeat,||
9012|192|O|hallucinations, fainting, seizures.||
9012|193|B|||
9012|194|N|NOTES:  If your doctor has prescribed this medication, do not||
9012|195|N|share it with others.||
9012|196|N|   Keep all medical and lab appointments.||
9012|197|B|||
9012|198|D|MISSED DOSE:  If you are taking this product on a regular||
9012|199|D|schedule and miss a dose, take it as soon as you remember. If it||
9012|200|D|is near the time of the next dose, skip the missed dose. Take||
9012|201|D|your next dose at the regular time. Do not double the dose to||
9012|202|D|catch up.||
9012|203|B|||
9012|204|R|STORAGE:  Store at room temperature away from light and moisture.||
9012|205|R|Do not store in the bathroom. Do not freeze liquid forms of this||
9012|206|R|medication. Keep all medications away from children and pets.||
9012|207|R|   Do not flush medications down the toilet or pour them into a||
9012|208|R|drain unless instructed to do so. Properly discard this product||
9012|209|R|when it is expired or no longer needed. Consult your pharmacist||
9012|210|R|or local waste disposal company.||
9012|211|B|||
9012|212|A|Information last revised July 2025.||
9012|213|A|Copyright(c) 2025 First Databank, Inc.||
9012|214|B|||
9016|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9016|002|Z|does NOT have all possible information about this product. This||
9016|003|Z|information does not assure that this product is safe, effective,||
9016|004|Z|or appropriate for you. This information is not individual||
9016|005|Z|medical advice and does not substitute for the advice of your||
9016|006|Z|health care professional. Always ask your health care||
9016|007|Z|professional for complete information about this product and your||
9016|008|Z|specific health needs.||
9016|009|B|||
9016|010|T|CLINDAMYCIN - TOPICAL||
9016|011|F|(KLIN-da-MYE-sin)||
9016|012|B|||
9016|013|C|COMMON BRAND NAME(S): Cleocin T||
9016|014|B|||
9016|015|U|USES:  This medication is used to treat acne. It helps to||
9016|016|U|decrease the number of acne lesions. Clindamycin is an antibiotic||
9016|017|U|which works by stopping the growth of bacteria.||
9016|018|B|||
9016|019|H|HOW TO USE:  This medication is for use on the skin only. Clean||
9016|020|H|and dry the affected area first. Apply this medication to the||
9016|021|H|affected area as directed by your doctor, usually twice daily.||
9016|022|H|Some gel products should only be used once daily. If you have any||
9016|023|H|questions, ask your doctor or pharmacist.||
9016|024|H|   If you are using the lotion, shake the bottle well before||
9016|025|H|using.||
9016|026|H|   Wash your hands after each use.||
9016|027|H|   Avoid getting this medication into your eyes, nose, mouth, or||
9016|028|H|on any areas of broken skin. If this medication gets in those||
9016|029|H|areas, rinse well with plenty of cool water.||
9016|030|H|   This solution is flammable until dry. If you are using the||
9016|031|H|solution, avoid smoking or being near open flames while using the||
9016|032|H|medication and until it has dried.||
9016|033|H|   Use this medication regularly to get the most benefit from it.||
9016|034|H|To help you remember, use it at the same time(s) each day.||
9016|035|H|   Do not increase your dose or use this drug more often or for||
9016|036|H|longer than prescribed. Your condition will not improve any||
9016|037|H|faster, and your risk of side effects will increase.||
9016|038|H|   It may take 2 to 6 weeks for your condition to get better, and||
9016|039|H|up to 12 weeks before you get the full benefit of this drug.||
9016|040|H|   Tell your doctor if your condition does not get better or if||
9016|041|H|it gets worse.||
9016|042|B|||
9016|043|S|SIDE EFFECTS:  Burning, itching, dryness, redness, oily skin or||
9016|044|S|skin peeling at the application site may occur. If any of these||
9016|045|S|effects last or get worse, tell your doctor or pharmacist||
9016|046|S|promptly.||
9016|047|S|   Remember that this medication has been prescribed because your||
9016|048|S|doctor has judged that the benefit to you is greater than the||
9016|049|S|risk of side effects. Many people using this medication do not||
9016|050|S|have serious side effects.||
9016|051|S|   This medication may be absorbed into your bloodstream and very||
9016|052|S|rarely cause a severe intestinal condition due to a bacteria||
9016|053|S|called C. difficile. This condition may occur during treatment or||
9016|054|S|weeks to months after treatment has stopped. Tell your doctor||
9016|055|S|right away if you develop: diarrhea that doesn't stop, abdominal||
9016|056|S|or stomach pain/cramping, blood/mucus in your stool.||
9016|057|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9016|058|S|products because they may make symptoms worse.||
9016|059|S|   A very serious allergic reaction to this drug is rare.||
9016|060|S|However, get medical help right away if you notice any symptoms||
9016|061|S|of a serious allergic reaction, including: rash, itching/swelling||
9016|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9016|063|S|breathing.||
9016|064|S|   This is not a complete list of possible side effects. If you||
9016|065|S|notice other effects not listed above, contact your doctor or||
9016|066|S|pharmacist.||
9016|067|S|   In the US -||
9016|068|S|   Call your doctor for medical advice about side effects. You||
9016|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9016|070|S|www.fda.gov/medwatch.||
9016|071|S|   In Canada - Call your doctor for medical advice about side||
9016|072|S|effects. You may report side effects to Health Canada at||
9016|073|S|1-866-234-2345.||
9016|074|B|||
9016|075|P|PRECAUTIONS:  Before using clindamycin, tell your doctor or||
9016|076|P|pharmacist if you are allergic to it; or to lincomycin; or if you||
9016|077|P|have any other allergies. This product may contain inactive||
9016|078|P|ingredients, which can cause allergic reactions or other||
9016|079|P|problems. Talk to your pharmacist for more details.||
9016|080|P|   Before using this medication, tell your doctor or pharmacist||
9016|081|P|your medical history, especially of: allergic conditions (such as||
9016|082|P|asthma, hay fever, eczema), intestinal diseases (such as||
9016|083|P|ulcerative colitis, enteritis, C. difficile-associated diarrhea).||
9016|084|P|   Before having surgery, tell your doctor or dentist about all||
9016|085|P|the products you use (including prescription drugs,||
9016|086|P|nonprescription drugs, and herbal products).||
9016|087|P|   Tell your doctor if you are pregnant before using this||
9016|088|P|medication.||
9016|089|P|   It is unknown if this medication passes into breast milk.||
9016|090|P|Consult your doctor before breastfeeding.||
9016|091|B|||
9016|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9016|093|I|medications work or increase your risk for serious side effects.||
9016|094|I|This document does not contain all possible drug interactions.||
9016|095|I|Keep a list of all the products you use (including||
9016|096|I|prescription/nonprescription drugs and herbal products) and share||
9016|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
9016|098|I|the dosage of any medicines without your doctor's approval.||
9016|099|B|||
9016|100|O|OVERDOSE:  This medication may be harmful if swallowed. If||
9016|101|O|someone has overdosed and has serious symptoms such as passing||
9016|102|O|out or trouble breathing, call 911. Otherwise, call a poison||
9016|103|O|control center right away. US residents can call 1-800-222-1222.||
9016|104|O|Canada residents can call 1-844-764-7669.||
9016|105|B|||
9016|106|N|NOTES:  Do not share this medication with others.||
9016|107|B|||
9016|108|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9016|109|D|If it is near the time of the next dose, skip the missed dose.||
9016|110|D|Use your next dose at the regular time. Do not double the dose to||
9016|111|D|catch up.||
9016|112|B|||
9016|113|R|STORAGE:  Store at room temperature. The solution is flammable.||
9016|114|R|Keep it away from heat and open flame. Keep all medications away||
9016|115|R|from children and pets.||
9016|116|R|   Do not flush medications down the toilet or pour them into a||
9016|117|R|drain unless instructed to do so. Properly discard this product||
9016|118|R|when it is expired or no longer needed. Consult your pharmacist||
9016|119|R|or local waste disposal company.||
9016|120|B|||
9016|121|A|Information last revised November 2025.||
9016|122|A|Copyright(c) 2025 First Databank, Inc.||
9016|123|B|||
9018|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9018|002|Z|does NOT have all possible information about this product. This||
9018|003|Z|information does not assure that this product is safe, effective,||
9018|004|Z|or appropriate for you. This information is not individual||
9018|005|Z|medical advice and does not substitute for the advice of your||
9018|006|Z|health care professional. Always ask your health care||
9018|007|Z|professional for complete information about this product and your||
9018|008|Z|specific health needs.||
9018|009|B|||
9018|010|T|PENTAZOCINE/NALOXONE - ORAL||
9018|011|F|(pen-TAZZ-oh-seen/nal-OX-own)||
9018|012|B|||
9018|013|C|COMMON BRAND NAME(S): Talwin NX||
9018|014|B|||
9018|015|W|WARNING:  Pentazocine has a risk for abuse and addiction, which||
9018|016|W|can lead to overdose and death. Pentazocine may also cause||
9018|017|W|severe, possibly fatal, breathing problems. To lower your risk,||
9018|018|W|your doctor should have you take the smallest dose of pentazocine||
9018|019|W|that works, and take it for the shortest possible time. See also||
9018|020|W|How to Use section for more information about addiction.||
9018|021|W|   Ask your doctor or pharmacist if you should have medication||
9018|022|W|available to treat opioid overdose (such as nalmefene, other||
9018|023|W|forms of naloxone). Teach your family or household members about||
9018|024|W|the signs of an opioid overdose and how to treat it.||
9018|025|W|   The risk for severe breathing problems is higher when you||
9018|026|W|start this medication and after a dose increase, or if you take||
9018|027|W|the wrong dose/strength. Taking this medication with alcohol or||
9018|028|W|other drugs that can cause drowsiness or breathing problems may||
9018|029|W|cause very serious side effects, including death. Be sure you||
9018|030|W|know how to take this medication and what other drugs you should||
9018|031|W|avoid taking with it. See also Drug Interactions section. Get||
9018|032|W|medical help right away if any of these very serious side effects||
9018|033|W|occur: slow/shallow breathing, unusual lightheadedness, severe||
9018|034|W|drowsiness/dizziness, difficulty waking up.||
9018|035|W|   This medication should only be taken by mouth. Do not try to||
9018|036|W|dissolve and inject the tablets. Injecting this product, alone or||
9018|037|W|with other substances, may cause serious, possibly fatal, side||
9018|038|W|effects.||
9018|039|W|   Keep this medicine in a safe place to prevent theft, misuse,||
9018|040|W|or abuse. If someone accidentally swallows this drug, get medical||
9018|041|W|help right away.||
9018|042|W|   Before using this medication, women of childbearing age should||
9018|043|W|talk with their doctor(s) about the risks and benefits. Tell your||
9018|044|W|doctor if you are pregnant or if you plan to become pregnant.||
9018|045|W|During pregnancy, this medication should be used only when||
9018|046|W|clearly needed. It may slightly increase the risk of birth||
9018|047|W|defects if used during the first two months of pregnancy. Also,||
9018|048|W|using it for a long time or in high doses near the expected||
9018|049|W|delivery date may harm the unborn baby. To lessen the risk, take||
9018|050|W|the smallest effective dose for the shortest possible time.||
9018|051|W|Babies born to mothers who use this drug for a long time may||
9018|052|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
9018|053|W|doctor right away if you notice any symptoms in your newborn baby||
9018|054|W|such as crying that doesn't stop, slow/shallow breathing,||
9018|055|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
9018|056|W|difficulty gaining weight.||
9018|057|B|||
9018|058|U|USES:  This product is used to treat moderate to severe pain. It||
9018|059|U|contains 2 medications, pentazocine and naloxone. Pentazocine is||
9018|060|U|an opioid pain reliever. It acts on certain centers in the brain||
9018|061|U|to give you pain relief. Naloxone helps to prevent misuse of this||
9018|062|U|product. It blocks the effect of pentazocine and may cause||
9018|063|U|withdrawal reactions if this product is dissolved and injected.||
9018|064|U|Naloxone does not have any effect when taken by mouth.||
9018|065|B|||
9018|066|H|HOW TO USE:  Take this medication by mouth with or without food||
9018|067|H|as directed by your doctor, usually every 3 to 4 hours. If you||
9018|068|H|have nausea, it may help to take this drug with food. Consult||
9018|069|H|your doctor or pharmacist about other ways to decrease nausea||
9018|070|H|(such as lying down for 1 to 2 hours with as little head movement||
9018|071|H|as possible).||
9018|072|H|   The dosage is based on your medical condition and response to||
9018|073|H|treatment. Do not take more than 600 milligrams of pentazocine in||
9018|074|H|a 24-hour period. Do not increase your dose, take the medication||
9018|075|H|more often, or take it for a longer time than prescribed.||
9018|076|H|Properly stop the medication when so directed.||
9018|077|H|   Pain medications work best if they are used when the first||
9018|078|H|signs of pain occur. If you wait until the pain has worsened, the||
9018|079|H|medication may not work as well.||
9018|080|H|   If you have been regularly using other opioid pain medications||
9018|081|H|(for example, morphine, methadone), withdrawal reactions (such as||
9018|082|H|restlessness, watery eyes, widened pupils, sweating, runny nose)||
9018|083|H|may occur when you start this product. Consult with your doctor||
9018|084|H|or pharmacist for more details.||
9018|085|H|   Suddenly stopping this medication may cause withdrawal,||
9018|086|H|especially if you have used it for a long time or in high doses.||
9018|087|H|To prevent withdrawal, your doctor may lower your dose slowly.||
9018|088|H|Tell your doctor or pharmacist right away if you have any||
9018|089|H|withdrawal symptoms such as restlessness, mental/mood changes||
9018|090|H|(including anxiety, trouble sleeping, thoughts of suicide),||
9018|091|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
9018|092|H|aches, or sudden changes in behavior.||
9018|093|H|   When this medication is used for a long time, it may not work||
9018|094|H|as well. Talk with your doctor if this medication stops working||
9018|095|H|well.||
9018|096|H|   Though it helps many people, this medication may sometimes||
9018|097|H|cause addiction. This risk may be higher if you have a||
9018|098|H|mental/mood disorder or a substance use disorder (such as overuse||
9018|099|H|of or addiction to drugs/alcohol). Take this medication exactly||
9018|100|H|as prescribed to lower the risk of addiction. Ask your doctor or||
9018|101|H|pharmacist for more details.||
9018|102|H|   Tell your doctor if your pain does not get better or if it||
9018|103|H|gets worse, or if you have any new pain.||
9018|104|B|||
9018|105|S|SIDE EFFECTS:  See also Warning section.||
9018|106|S|   Nausea, vomiting, constipation, lightheadedness, dizziness,||
9018|107|S|drowsiness, increased sweating, headache, or dry mouth may occur.||
9018|108|S|If any of these effects last or get worse, tell your doctor or||
9018|109|S|pharmacist promptly.||
9018|110|S|   To prevent constipation, eat dietary fiber, drink enough||
9018|111|S|water, and exercise. You may also need to take a laxative. Ask||
9018|112|S|your pharmacist which type of laxative is right for you.||
9018|113|S|   To reduce the risk of dizziness and lightheadedness, get up||
9018|114|S|slowly when rising from a sitting or lying position.||
9018|115|S|   Remember that this medication has been prescribed because your||
9018|116|S|doctor has judged that the benefit to you is greater than the||
9018|117|S|risk of side effects. Many people using this medication do not||
9018|118|S|have serious side effects.||
9018|119|S|   Tell your doctor right away if you have any serious side||
9018|120|S|effects, including: interrupted breathing during sleep (sleep||
9018|121|S|apnea), mental/mood changes (such as agitation, hallucinations,||
9018|122|S|confusion), difficulty urinating, vision changes, fast heartbeat,||
9018|123|S|stomach/abdominal pain, signs of your adrenal glands not working||
9018|124|S|well (such as loss of appetite, unusual tiredness, weight loss),||
9018|125|S|trouble swallowing.||
9018|126|S|   Get medical help right away if you have any very serious side||
9018|127|S|effects, including: slow/shallow breathing, seizures, fainting,||
9018|128|S|severe drowsiness/difficulty waking up.||
9018|129|S|   A very serious allergic reaction to this drug is rare.||
9018|130|S|However, get medical help right away if you notice any symptoms||
9018|131|S|of a serious allergic reaction, including: rash, itching/swelling||
9018|132|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9018|133|S|breathing.||
9018|134|S|   This is not a complete list of possible side effects. If you||
9018|135|S|notice other effects not listed above, contact your doctor or||
9018|136|S|pharmacist.||
9018|137|S|   In the US -||
9018|138|S|   Call your doctor for medical advice about side effects. You||
9018|139|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9018|140|S|www.fda.gov/medwatch.||
9018|141|S|   In Canada - Call your doctor for medical advice about side||
9018|142|S|effects. You may report side effects to Health Canada at||
9018|143|S|1-866-234-2345.||
9018|144|B|||
9018|145|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
9018|146|P|pharmacist if you are allergic to pentazocine or naloxone; or if||
9018|147|P|you have any other allergies. This product may contain inactive||
9018|148|P|ingredients, which can cause allergic reactions or other||
9018|149|P|problems. Talk to your pharmacist for more details.||
9018|150|P|   Before using this medication, tell your doctor or pharmacist||
9018|151|P|your medical history, especially of: brain disorders (such as||
9018|152|P|seizures, head injury, tumor), breathing problems (such as||
9018|153|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
9018|154|P|gallbladder disease, heart problems (such as irregular heartbeat,||
9018|155|P|recent heart attack), kidney disease, liver disease, mental/mood||
9018|156|P|disorders (such as confusion, depression, thoughts of suicide),||
9018|157|P|personal or family history of a substance use disorder (such as||
9018|158|P|overuse of or addiction to drugs/alcohol), stomach/intestinal||
9018|159|P|problems (such as blockage, constipation, diarrhea due to||
9018|160|P|infection, paralytic ileus), disease of the pancreas||
9018|161|P|(pancreatitis), difficulty urinating (such as due to enlarged||
9018|162|P|prostate), certain blood disorder (porphyria).||
9018|163|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9018|164|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9018|165|P|machinery, or do anything that needs alertness until you can do||
9018|166|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
9018|167|P|are using marijuana (cannabis).||
9018|168|P|   Before having surgery, tell your doctor or dentist about all||
9018|169|P|the products you use (including prescription drugs,||
9018|170|P|nonprescription drugs, and herbal products).||
9018|171|P|   Older adults may be more sensitive to the side effects of this||
9018|172|P|drug, especially confusion, dizziness, drowsiness, and||
9018|173|P|slow/shallow breathing.||
9018|174|P|   During pregnancy, this medication should be used only when||
9018|175|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
9018|176|P|benefits with your doctor. (See also Warning section.)||
9018|177|P|   This drug may pass into breast milk and may have undesirable||
9018|178|P|effects on a nursing infant. Tell the doctor right away if your||
9018|179|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
9018|180|P|breathing. Consult your doctor before breastfeeding.||
9018|181|B|||
9018|182|I|DRUG INTERACTIONS:  See also Warning and How to Use sections.||
9018|183|I|   Drug interactions may change how your medications work or||
9018|184|I|increase your risk for serious side effects. This document does||
9018|185|I|not contain all possible drug interactions. Keep a list of all||
9018|186|I|the products you use (including prescription/nonprescription||
9018|187|I|drugs and herbal products) and share it with your doctor and||
9018|188|I|pharmacist. Do not start, stop, or change the dosage of any||
9018|189|I|medicines without your doctor's approval.||
9018|190|I|   Some products that may interact with this drug include:||
9018|191|I|fluoxetine, naltrexone, samidorphan.||
9018|192|I|   Taking MAO inhibitors with this medication may cause a serious||
9018|193|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9018|194|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9018|195|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9018|196|I|selegiline, tranylcypromine) during treatment with this||
9018|197|I|medication. Most MAO inhibitors should also not be taken for two||
9018|198|I|weeks before treatment with this medication. Ask your doctor when||
9018|199|I|to start or stop taking this medication.||
9018|200|I|   The risk of serious side effects (such as slow/shallow||
9018|201|I|breathing, severe drowsiness/dizziness) may be increased if this||
9018|202|I|medication is taken with other products that may also cause||
9018|203|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
9018|204|I|if you are taking other products such as other opioid pain or||
9018|205|I|cough relievers (such as codeine, hydrocodone), alcohol,||
9018|206|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
9018|207|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
9018|208|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
9018|209|I|cetirizine, diphenhydramine).||
9018|210|I|   Check the labels on all your medicines (such as allergy or||
9018|211|I|cough-and-cold products) because they may contain ingredients||
9018|212|I|that cause drowsiness. Ask your pharmacist about using those||
9018|213|I|products safely.||
9018|214|I|   Cigarette smoking decreases blood levels of this medication.||
9018|215|I|Tell your doctor if you smoke or if you have recently stopped||
9018|216|I|smoking.||
9018|217|I|   This medication may interfere with certain lab tests (such as||
9018|218|I|amylase/lipase levels), possibly causing false test results. Make||
9018|219|I|sure lab personnel and all your doctors know you use this drug.||
9018|220|B|||
9018|221|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9018|222|O|as passing out or trouble breathing, give them naloxone by itself||
9018|223|O|or nalmefene if available, then call 911. If the person is awake||
9018|224|O|and has no symptoms, call a poison control center right away. US||
9018|225|O|residents can call 1-800-222-1222. Canada residents can call||
9018|226|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
9018|227|O|breathing, severe drowsiness, severe dizziness, pinpoint pupils,||
9018|228|O|coma.||
9018|229|B|||
9018|230|N|NOTES:  Do not share this medication with others. Sharing it is||
9018|231|N|against the law.||
9018|232|N|   This medication has been prescribed for your current condition||
9018|233|N|only. Do not use it later for another condition unless told to do||
9018|234|N|so by your doctor. A different medication may be necessary in||
9018|235|N|that case.||
9018|236|B|||
9018|237|D|MISSED DOSE:  If you take this product regularly and miss a dose,||
9018|238|D|take it as soon as you remember. If it is near the time of the||
9018|239|D|next dose, skip the missed dose. Take your next dose at the||
9018|240|D|regular time. Do not double the dose to catch up.||
9018|241|B|||
9018|242|R|STORAGE:  Store at room temperature away from light and moisture.||
9018|243|R|Do not store in the bathroom. Keep all medications away from||
9018|244|R|children and pets.||
9018|245|R|   Do not flush medications down the toilet or pour them into a||
9018|246|R|drain unless instructed to do so. Properly discard this product||
9018|247|R|when it is expired or no longer needed. Consult your pharmacist||
9018|248|R|or local waste disposal company.||
9018|249|B|||
9018|250|A|Information last revised August 2025.||
9018|251|A|Copyright(c) 2025 First Databank, Inc.||
9018|252|B|||
9019|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9019|002|Z|does NOT have all possible information about this product. This||
9019|003|Z|information does not assure that this product is safe, effective,||
9019|004|Z|or appropriate for you. This information is not individual||
9019|005|Z|medical advice and does not substitute for the advice of your||
9019|006|Z|health care professional. Always ask your health care||
9019|007|Z|professional for complete information about this product and your||
9019|008|Z|specific health needs.||
9019|009|B|||
9019|010|T|VALPROATE SODIUM SYRUP - ORAL||
9019|011|F|(val-PRO-ate SO-dee-um)||
9019|012|B|||
9019|013|C|COMMON BRAND NAME(S): Depakene||
9019|014|B|||
9019|015|W|WARNING:  Rarely, this medication has caused serious (sometimes||
9019|016|W|fatal) liver problems, usually within the first 6 months of||
9019|017|W|starting treatment. Lab tests should be performed before you||
9019|018|W|start treatment and periodically during treatment, especially||
9019|019|W|within the first 6 months, to monitor this side effect.||
9019|020|W|   The risk of serious liver problems is increased in children||
9019|021|W|younger than 2 years, especially if they have an inherited||
9019|022|W|metabolic disorder, severe seizure disorder with mental||
9019|023|W|retardation, organic brain disease, or if they take more than one||
9019|024|W|seizure medication. Talk with the doctor about the risks and||
9019|025|W|benefits of using this medication in children younger than 2||
9019|026|W|years.||
9019|027|W|   Due to an increased risk for liver problems, people with||
9019|028|W|certain inherited metabolic disorders (such as||
9019|029|W|Alpers-Huttenlocher syndrome) should not use this medication.||
9019|030|W|Children younger than 2 years who might have these disorders||
9019|031|W|should not use this medication. Children older than 2 years who||
9019|032|W|might have these disorders should be closely monitored during||
9019|033|W|treatment with valproate sodium. Talk to your doctor for details.||
9019|034|W|   This medication has rarely caused severe (sometimes fatal)||
9019|035|W|disease of the pancreas (pancreatitis). This may occur at any||
9019|036|W|time during treatment and can quickly worsen.||
9019|037|W|   Tell your doctor right away if you develop symptoms of liver||
9019|038|W|problems or pancreatitis such as nausea/vomiting that doesn't||
9019|039|W|stop, unusual tiredness, weakness, swelling of the face,||
9019|040|W|stomach/abdominal pain, loss of appetite, dark urine, or||
9019|041|W|yellowing eyes/skin.||
9019|042|W|   Taking this medication during pregnancy can cause birth||
9019|043|W|defects, may lower your child's IQ, and may increase the risk of||
9019|044|W|your child having certain brain/mental disorders (such as autism,||
9019|045|W|attention deficit/hyperactivity disorder). Men and women using||
9019|046|W|this medication should discuss the risks and benefits of this||
9019|047|W|medication, other treatment options, and use of reliable forms of||
9019|048|W|birth control with their doctor. If you are planning pregnancy,||
9019|049|W|or if you or your partner becomes pregnant or may be pregnant,||
9019|050|W|immediately talk to your doctor. If you are taking valproate||
9019|051|W|sodium only to prevent migraine headaches, this medication must||
9019|052|W|not be used during pregnancy. If you are taking valproate sodium||
9019|053|W|to treat seizures or mental/mood problems (such as bipolar||
9019|054|W|disorder), do not stop taking this medication unless directed by||
9019|055|W|your doctor. Untreated seizures and mental/mood problems (such as||
9019|056|W|bipolar disorder) are serious conditions that can harm both a||
9019|057|W|pregnant woman and her unborn baby.||
9019|058|B|||
9019|059|U|USES:  This medication is used to treat seizure disorders,||
9019|060|U|mental/mood conditions (such as manic phase of bipolar disorder),||
9019|061|U|and to prevent migraine headaches. It works by restoring the||
9019|062|U|balance of certain natural substances (neurotransmitters) in the||
9019|063|U|brain.||
9019|064|B|||
9019|065|H|HOW TO USE:  Read the Medication Guide and, if available, the||
9019|066|H|Patient Information Leaflet provided by your pharmacist before||
9019|067|H|you start taking valproate sodium and each time you get a refill.||
9019|068|H|If you have any questions, ask your doctor or pharmacist.||
9019|069|H|   Take this medication by mouth as directed by your doctor. You||
9019|070|H|may take it with food if stomach upset occurs. Use a specially||
9019|071|H|marked device to measure the correct amount of medication.||
9019|072|H|Valproate sodium syrup should not be mixed with carbonated drinks||
9019|073|H|because it may irritate the mouth and throat.||
9019|074|H|   The dosage is based on your age, weight, medical condition,||
9019|075|H|response to treatment, and other medications you may be taking.||
9019|076|H|Be sure to tell your doctor and pharmacist about all the products||
9019|077|H|you use (including prescription drugs, nonprescription drugs, and||
9019|078|H|herbal products). Use this medication regularly in order to get||
9019|079|H|the most benefit from it. Remember to use it at the same time||
9019|080|H|each day to keep the amount of medication in your blood constant.||
9019|081|H|   If this medication is used for seizures, do not stop taking it||
9019|082|H|without consulting your doctor. Your condition may become worse||
9019|083|H|if the drug is suddenly stopped. Your dose may need to be||
9019|084|H|gradually decreased.||
9019|085|H|   This medication does not relieve acute migraine headaches.||
9019|086|H|Take other medications as directed by your doctor for acute||
9019|087|H|attacks.||
9019|088|H|   Tell your doctor if your condition does not get better.||
9019|089|B|||
9019|090|S|SIDE EFFECTS:  See also Warning section.||
9019|091|S|   Diarrhea, dizziness, drowsiness, hair loss, blurred/double||
9019|092|S|vision, change in menstrual periods, ringing in the ears,||
9019|093|S|shakiness (tremor), unsteadiness, weight changes may occur. If||
9019|094|S|any of these effects last or get worse, tell your doctor or||
9019|095|S|pharmacist promptly.||
9019|096|S|   Remember that this medication has been prescribed because your||
9019|097|S|doctor has judged that the benefit to you is greater than the||
9019|098|S|risk of side effects. Many people using this medication do not||
9019|099|S|have serious side effects.||
9019|100|S|   A small number of people who take anticonvulsants for any||
9019|101|S|condition (such as seizure, bipolar disorder, pain) may||
9019|102|S|experience depression, suicidal thoughts/attempts, or other||
9019|103|S|mental/mood problems. Tell your doctor right away if you or your||
9019|104|S|family/caregiver notice any unusual/sudden changes in your mood,||
9019|105|S|thoughts, or behavior including signs of depression, suicidal||
9019|106|S|thoughts/attempts, thoughts about harming yourself.||
9019|107|S|   Severe (sometimes fatal) brain disorder (encephalopathy) has||
9019|108|S|rarely occurred, particularly in patients with certain metabolic||
9019|109|S|disorders (urea cycle disorders). Tell your doctor right away if||
9019|110|S|you develop unexplained weakness, vomiting, or sudden mental/mood||
9019|111|S|changes (such as confusion).||
9019|112|S|   Get medical help right away if you have any very serious side||
9019|113|S|effects, including: chest pain, easy bruising/unexplained||
9019|114|S|bleeding, fast/slow/irregular heartbeat, swelling of hands/feet,||
9019|115|S|uncontrolled eye movement (nystagmus), feeling cold/shivering,||
9019|116|S|rapid breathing, loss of consciousness.||
9019|117|S|   A very serious allergic reaction to this drug is rare.||
9019|118|S|However, get medical help right away if you notice any symptoms||
9019|119|S|of a serious allergic reaction, including: fever, swollen lymph||
9019|120|S|nodes, rash, itching/swelling (especially of the||
9019|121|S|face/tongue/throat), severe dizziness, trouble breathing.||
9019|122|S|   This is not a complete list of possible side effects. If you||
9019|123|S|notice other effects not listed above, contact your doctor or||
9019|124|S|pharmacist.||
9019|125|S|   In the US -||
9019|126|S|   Call your doctor for medical advice about side effects. You||
9019|127|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9019|128|S|www.fda.gov/medwatch.||
9019|129|S|   In Canada - Call your doctor for medical advice about side||
9019|130|S|effects. You may report side effects to Health Canada at||
9019|131|S|1-866-234-2345.||
9019|132|B|||
9019|133|P|PRECAUTIONS:  See also Warning section.||
9019|134|P|   Before taking valproate sodium, tell your doctor or pharmacist||
9019|135|P|if you are allergic to it; or to valproic acid or divalproex||
9019|136|P|sodium; or if you have any other allergies. This product may||
9019|137|P|contain inactive ingredients, which can cause allergic reactions||
9019|138|P|or other problems. Talk to your pharmacist for more details.||
9019|139|P|   Before using this medication, tell your doctor or pharmacist||
9019|140|P|your medical history, especially of: liver disease, pancreatitis,||
9019|141|P|certain metabolic disorders (such as urea cycle disorders,||
9019|142|P|Alpers-Huttenlocher syndrome), alcohol abuse, bleeding problems,||
9019|143|P|brain disease (dementia), kidney disease, dehydration, poor||
9019|144|P|nutrition.||
9019|145|P|   To lower the chance of getting cut, bruised, or injured, use||
9019|146|P|caution with sharp objects like razors and nail cutters, and||
9019|147|P|avoid activities such as contact sports.||
9019|148|P|   Before having surgery, tell your doctor or dentist about all||
9019|149|P|the products you use (including prescription drugs,||
9019|150|P|nonprescription drugs, and herbal products).||
9019|151|P|   This drug may make you dizzy or drowsy or blur your vision.||
9019|152|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9019|153|P|drowsy. Do not drive, use machinery, or do anything that needs||
9019|154|P|alertness or clear vision until you can do it safely. Avoid||
9019|155|P|alcoholic beverages. Talk to your doctor if you are using||
9019|156|P|marijuana (cannabis).||
9019|157|P|   Children younger than 6 years may be at greater risk for liver||
9019|158|P|problems and pancreatitis.||
9019|159|P|   Older adults may be more sensitive to the side effects of this||
9019|160|P|drug, especially drowsiness, dizziness, unsteadiness, or tremor.||
9019|161|P|Drowsiness, dizziness, unsteadiness can increase the risk of||
9019|162|P|falling.||
9019|163|P|   Tell your doctor if you are pregnant or plan to become||
9019|164|P|pregnant. You should not become pregnant while using valproate||
9019|165|P|sodium. Valproate sodium may harm an unborn baby. If you become||
9019|166|P|pregnant, talk to your doctor right away about the risks and||
9019|167|P|benefits of this medication. See also Warning section.||
9019|168|P|   This medication passes into breast milk. Consult your doctor||
9019|169|P|before breastfeeding.||
9019|170|B|||
9019|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9019|172|I|medications work or increase your risk for serious side effects.||
9019|173|I|This document does not contain all possible drug interactions.||
9019|174|I|Keep a list of all the products you use (including||
9019|175|I|prescription/nonprescription drugs and herbal products) and share||
9019|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
9019|177|I|the dosage of any medicines without your doctor's approval.||
9019|178|I|   Some products that may interact with this drug include:||
9019|179|I|certain antidepressants (such as amitriptyline, nortriptyline,||
9019|180|I|phenelzine), certain antibiotics (carbapenems such as imipenem),||
9019|181|I|mefloquine, orlistat, other medications for seizure (such as||
9019|182|I|ethosuximide, lamotrigine, rufinamide, topiramate), vorinostat,||
9019|183|I|warfarin, zidovudine.||
9019|184|I|   Tell your doctor or pharmacist if you are taking other||
9019|185|I|products that cause drowsiness including alcohol, marijuana||
9019|186|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
9019|187|I|drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle||
9019|188|I|relaxants (such as carisoprodol, cyclobenzaprine), and opioid||
9019|189|I|pain relievers (such as codeine, hydrocodone).||
9019|190|I|   Check the labels on all your medicines (such as allergy or||
9019|191|I|cough-and-cold products) because they may contain ingredients||
9019|192|I|that cause drowsiness. Ask your pharmacist about using those||
9019|193|I|products safely.||
9019|194|I|   This drug may interfere with certain lab tests (such as urine||
9019|195|I|ketones). Make sure lab personnel and your doctors know you use||
9019|196|I|this medication.||
9019|197|B|||
9019|198|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9019|199|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9019|200|O|poison control center right away. US residents can call||
9019|201|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9019|202|O|Symptoms of overdose may include excessive drowsiness, coma,||
9019|203|O|irregular/slow heartbeat.||
9019|204|B|||
9019|205|N|NOTES:  Do not share this medication with others.||
9019|206|N|   Lab and/or medical tests (such as drug levels, liver function,||
9019|207|N|complete blood counts, clotting tests) should be done before you||
9019|208|N|start taking this medication and while you are taking it. Keep||
9019|209|N|all medical and lab appointments. Consult your doctor for more||
9019|210|N|details.||
9019|211|B|||
9019|212|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9019|213|D|If it is near the time of the next dose, skip the missed dose.||
9019|214|D|Use your next dose at the regular time. Do not double the dose to||
9019|215|D|catch up.||
9019|216|B|||
9019|217|R|STORAGE:  Store at room temperature away from light and moisture.||
9019|218|R|Do not store in the bathroom. Keep all medications away from||
9019|219|R|children and pets.||
9019|220|R|   Do not flush medications down the toilet or pour them into a||
9019|221|R|drain unless instructed to do so. Properly discard this product||
9019|222|R|when it is expired or no longer needed. Consult your pharmacist||
9019|223|R|or local waste disposal company.||
9019|224|B|||
9019|225|M|MEDICAL ALERT:  Your condition can cause complications in a||
9019|226|M|medical emergency. For information about enrolling in MedicAlert,||
9019|227|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9019|228|B|||
9019|229|A|Information last revised January 2025.||
9019|230|A|Copyright(c) 2025 First Databank, Inc.||
9019|231|B|||
9021|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9021|002|Z|does NOT have all possible information about this product. This||
9021|003|Z|information does not assure that this product is safe, effective,||
9021|004|Z|or appropriate for you. This information is not individual||
9021|005|Z|medical advice and does not substitute for the advice of your||
9021|006|Z|health care professional. Always ask your health care||
9021|007|Z|professional for complete information about this product and your||
9021|008|Z|specific health needs.||
9021|009|B|||
9021|010|T|FLUOCINOLONE (ECZEMA) OIL - TOPICAL||
9021|011|F|(FLOO-oh-SIN-oh-lone)||
9021|012|B|||
9021|013|C|COMMON BRAND NAME(S): Derma-Smoothe/FS||
9021|014|B|||
9021|015|U|USES:  This medication is used to treat eczema, a skin condition||
9021|016|U|which causes red, irritated, and itchy skin. Fluocinolone reduces||
9021|017|U|these symptoms. This medication is a low- to medium-strength||
9021|018|U|corticosteroid.||
9021|019|B|||
9021|020|H|HOW TO USE:  Shake well before each use. Use this medication on||
9021|021|H|the skin only. However, do not use it on the face, groin, or||
9021|022|H|underarms unless directed to do so by your doctor. Do not apply||
9021|023|H|this medication to the diaper area.||
9021|024|H|   Wash and dry your hands before using. Clean and dry the||
9021|025|H|affected area. Apply a thin film of medication to the affected||
9021|026|H|area and gently rub in as directed by your doctor, usually 3||
9021|027|H|times daily. Do not bandage, cover, or wrap the area unless||
9021|028|H|directed to do so by your doctor.||
9021|029|H|   After applying the medication, wash your hands unless you are||
9021|030|H|using this medication to treat the hands. Avoid getting this||
9021|031|H|medication in the eyes, nose, or mouth. If you get the medication||
9021|032|H|in these areas, rinse with plenty of water.||
9021|033|H|   Use this medication only for the condition for which it was||
9021|034|H|prescribed. Do not use it for longer than prescribed.||
9021|035|H|   Tell your doctor if your condition lasts or gets worse after 2||
9021|036|H|weeks.||
9021|037|B|||
9021|038|S|SIDE EFFECTS:  Stinging, burning, irritation, dryness, or redness||
9021|039|S|at the application site may occur. Acne, excessive hair growth,||
9021|040|S|small red bumps on the skin (folliculitis), skin||
9021|041|S|thinning/discoloration, or stretch marks may also occur. If any||
9021|042|S|of these effects last or get worse, tell your doctor or||
9021|043|S|pharmacist promptly.||
9021|044|S|   Remember that this medication has been prescribed because your||
9021|045|S|doctor has judged that the benefit to you is greater than the||
9021|046|S|risk of side effects. Many people using this medication do not||
9021|047|S|have serious side effects.||
9021|048|S|   Rarely, it is possible this medication will be absorbed from||
9021|049|S|the skin into the bloodstream. This can lead to side effects of||
9021|050|S|too much corticosteroid. These side effects are more likely in||
9021|051|S|children, and in people who use this medication for a long time||
9021|052|S|or over large areas of the skin. Tell your doctor right away if||
9021|053|S|any of the following side effects occur: unusual/extreme||
9021|054|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
9021|055|S|thirst/urination, vision problems.||
9021|056|S|   A very serious allergic reaction to this drug is rare.||
9021|057|S|However, get medical help right away if you notice any symptoms||
9021|058|S|of a serious allergic reaction, including: rash, itching/swelling||
9021|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9021|060|S|breathing.||
9021|061|S|   This is not a complete list of possible side effects. If you||
9021|062|S|notice other effects not listed above, contact your doctor or||
9021|063|S|pharmacist.||
9021|064|S|   In the US -||
9021|065|S|   Call your doctor for medical advice about side effects. You||
9021|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9021|067|S|www.fda.gov/medwatch.||
9021|068|S|   In Canada - Call your doctor for medical advice about side||
9021|069|S|effects. You may report side effects to Health Canada at||
9021|070|S|1-866-234-2345.||
9021|071|B|||
9021|072|P|PRECAUTIONS:  Before using fluocinolone, tell your doctor or||
9021|073|P|pharmacist if you are allergic to it; or to other corticosteroids||
9021|074|P|(such as hydrocortisone, prednisone); or if you have any other||
9021|075|P|allergies. This product may contain inactive ingredients (such as||
9021|076|P|peanut oil), which can cause allergic reactions or other||
9021|077|P|problems. Talk to your pharmacist for more details.||
9021|078|P|   Before using this medication, tell your doctor or pharmacist||
9021|079|P|your medical history.||
9021|080|P|   Do not use if there is an infection or sore in the area to be||
9021|081|P|treated. Skin infections can become worse when this medication is||
9021|082|P|used. Notify your doctor promptly if redness, swelling, or||
9021|083|P|irritation does not improve.||
9021|084|P|   Rarely, using corticosteroid medications for a long time or||
9021|085|P|over large areas of skin can make it more difficult for your body||
9021|086|P|to respond to physical stress. Before having surgery or emergency||
9021|087|P|treatment, or if you get a serious illness/injury, tell your||
9021|088|P|doctor or dentist that you are using this medication or have used||
9021|089|P|this medication within the past few months.||
9021|090|P|   Though it is unlikely, this medication may temporarily slow||
9021|091|P|down a child's growth if used for a long time. See the doctor||
9021|092|P|regularly so your child's height can be checked.||
9021|093|P|   During pregnancy, this medication should be used only when||
9021|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
9021|095|P|   It is unknown if this drug passes into breast milk when||
9021|096|P|applied to the skin. Similar medications pass into breast milk||
9021|097|P|when taken by mouth. Consult your doctor before breastfeeding.||
9021|098|B|||
9021|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9021|100|I|medications work or increase your risk for serious side effects.||
9021|101|I|This document does not contain all possible drug interactions.||
9021|102|I|Keep a list of all the products you use (including||
9021|103|I|prescription/nonprescription drugs and herbal products) and share||
9021|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
9021|105|I|the dosage of any medicines without your doctor's approval.||
9021|106|B|||
9021|107|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9021|108|O|has overdosed and has serious symptoms such as passing out or||
9021|109|O|trouble breathing, call 911. Otherwise, call a poison control||
9021|110|O|center right away. US residents can call 1-800-222-1222. Canada||
9021|111|O|residents can call 1-844-764-7669.||
9021|112|B|||
9021|113|N|NOTES:  Do not share this medication with others.||
9021|114|N|   Lab and/or medical tests (such as adrenal gland function) may||
9021|115|N|be done while you are using this medication, especially if you||
9021|116|N|use this drug for an extended period of time or apply it over||
9021|117|N|large areas of the body. Keep all medical and lab appointments.||
9021|118|N|Consult your doctor for more details.||
9021|119|B|||
9021|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9021|121|D|If it is near the time of the next dose, skip the missed dose.||
9021|122|D|Use your next dose at the regular time. Do not double the dose to||
9021|123|D|catch up.||
9021|124|B|||
9021|125|R|STORAGE:  Store at room temperature. Keep all medications away||
9021|126|R|from children and pets.||
9021|127|R|   Do not flush medications down the toilet or pour them into a||
9021|128|R|drain unless instructed to do so. Properly discard this product||
9021|129|R|when it is expired or no longer needed. Consult your pharmacist||
9021|130|R|or local waste disposal company.||
9021|131|B|||
9021|132|A|Information last revised May 2024.||
9021|133|A|Copyright(c) 2025 First Databank, Inc.||
9021|134|B|||
9024|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9024|002|Z|does NOT have all possible information about this product. This||
9024|003|Z|information does not assure that this product is safe, effective,||
9024|004|Z|or appropriate for you. This information is not individual||
9024|005|Z|medical advice and does not substitute for the advice of your||
9024|006|Z|health care professional. Always ask your health care||
9024|007|Z|professional for complete information about this product and your||
9024|008|Z|specific health needs.||
9024|009|B|||
9024|010|T|CLONIDINE - TRANSDERMAL||
9024|011|F|(KLON-i-deen)||
9024|012|B|||
9024|013|C|COMMON BRAND NAME(S): Catapres-TTS||
9024|014|B|||
9024|015|U|USES:  This medication is used alone or with other medications to||
9024|016|U|treat high blood pressure (hypertension). Lowering high blood||
9024|017|U|pressure helps prevent strokes, heart attacks, and kidney||
9024|018|U|problems. Clonidine belongs to a class of drugs (central alpha||
9024|019|U|agonists) that act in the brain to lower blood pressure. It works||
9024|020|U|by relaxing blood vessels so blood can flow more easily.||
9024|021|B|||
9024|022|V|OTHER USES:  This section contains uses of this drug that are not||
9024|023|V|listed in the approved professional labeling for the drug but||
9024|024|V|that may be prescribed by your health care professional. Use this||
9024|025|V|drug for a condition that is listed in this section only if it||
9024|026|V|has been so prescribed by your health care professional.||
9024|027|V|   This drug may also be used for attention deficit hyperactivity||
9024|028|V|disorder (ADHD), for hot flashes that occur with menopause, for||
9024|029|V|withdrawal symptoms from opioid drugs, and to help people quit||
9024|030|V|smoking.||
9024|031|B|||
9024|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9024|033|H|from your pharmacist before you start taking clonidine and each||
9024|034|H|time you get a refill. If you have any questions, ask your doctor||
9024|035|H|or pharmacist.||
9024|036|H|   Peel off the backing from the patch and apply the patch to a||
9024|037|H|clean, dry, and hairless area of the skin on the upper outer arm||
9024|038|H|or upper chest. Press the patch firmly in place for about 10||
9024|039|H|seconds to make sure it stays on. Do not apply the patch on oily,||
9024|040|H|broken, or irritated skin. Avoid applying the patch to areas of||
9024|041|H|the skin where it might be easily rubbed off (such as on skin||
9024|042|H|folds). Do not cut the patch or use the patch if it appears||
9024|043|H|broken, cut, or damaged. Use this medication as directed by your||
9024|044|H|doctor. The patch is usually worn for 1 week and then replaced.||
9024|045|H|Follow the dosing schedule carefully. Wash your hands after||
9024|046|H|handling the patch.||
9024|047|H|   The dosage is based on your medical condition and response to||
9024|048|H|treatment.||
9024|049|H|   When replacing your patch, make sure to apply the new patch to||
9024|050|H|a different area. Fold the old patch in half with the sticky side||
9024|051|H|together and throw away in the trash away from children and pets.||
9024|052|H|Do not flush the patch down the toilet.||
9024|053|H|   If the patch starts to loosen from the skin, you may apply the||
9024|054|H|"adhesive cover" over the patch so that it does not fall off||
9024|055|H|during the 1-week period. The "adhesive cover" does not contain||
9024|056|H|any medication. If the patch falls off or if you have mild||
9024|057|H|redness/itching/irritation around the application site, discard||
9024|058|H|the patch as directed and apply a new patch to a different area.||
9024|059|H|   Use this medication regularly to get the most benefit from it.||
9024|060|H|To help you remember, change the patch on the same day each week.||
9024|061|H|Mark your calendar with a reminder. Keep using this medication||
9024|062|H|even if you feel well. Most people with high blood pressure do||
9024|063|H|not feel sick.||
9024|064|H|   Do not stop using this medication without consulting your||
9024|065|H|doctor. You may experience symptoms such as nervousness,||
9024|066|H|agitation, shaking, and headache. A rapid rise in blood pressure||
9024|067|H|may also occur if the drug is suddenly stopped. The risk is||
9024|068|H|greater if you have used this drug for a long time or in high||
9024|069|H|doses, or if you are also taking a beta blocker (such as||
9024|070|H|atenolol). There have also been rare reports of severe, possibly||
9024|071|H|fatal reactions (such as stroke) from stopping this drug too||
9024|072|H|quickly. It is important that you do not run out of clonidine||
9024|073|H|patches or miss any doses. To prevent any reactions while you are||
9024|074|H|stopping treatment with this drug, your doctor may reduce your||
9024|075|H|dose gradually. Consult your doctor or pharmacist for more||
9024|076|H|details. Report any new or worsening symptoms right away.||
9024|077|H|   When used for a long time, this medication may not work as||
9024|078|H|well and may require different dosing or an additional||
9024|079|H|medication. Talk with your doctor if this medication stops||
9024|080|H|working well (such as your blood pressure readings remain high or||
9024|081|H|increase).||
9024|082|B|||
9024|083|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, dry mouth,||
9024|084|S|unusual tiredness, headache, or mild redness/itching/irritation||
9024|085|S|at the application site may occur. If any of these effects last||
9024|086|S|or get worse, tell your doctor or pharmacist promptly.||
9024|087|S|   To reduce the risk of dizziness and lightheadedness, get up||
9024|088|S|slowly when rising from a sitting or lying position.||
9024|089|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
9024|090|S|chips, chew (sugarless) gum, drink water, or use a saliva||
9024|091|S|substitute.||
9024|092|S|   Remember that this medication has been prescribed because your||
9024|093|S|doctor has judged that the benefit to you is greater than the||
9024|094|S|risk of side effects. Many people using this medication do not||
9024|095|S|have serious side effects.||
9024|096|S|   Tell your doctor right away if you have any serious side||
9024|097|S|effects, including: fainting, slow/irregular heartbeat,||
9024|098|S|mental/mood changes (such as irritability, depression).||
9024|099|S|   A very serious allergic reaction to this drug is rare.||
9024|100|S|However, get medical help right away if you notice any symptoms||
9024|101|S|of a serious allergic reaction, including: rash, itching/swelling||
9024|102|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9024|103|S|breathing.||
9024|104|S|   This is not a complete list of possible side effects. If you||
9024|105|S|notice other effects not listed above, contact your doctor or||
9024|106|S|pharmacist.||
9024|107|S|   In the US -||
9024|108|S|   Call your doctor for medical advice about side effects. You||
9024|109|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9024|110|S|www.fda.gov/medwatch.||
9024|111|S|   In Canada - Call your doctor for medical advice about side||
9024|112|S|effects. You may report side effects to Health Canada at||
9024|113|S|1-866-234-2345.||
9024|114|B|||
9024|115|P|PRECAUTIONS:  Before using clonidine, tell your doctor or||
9024|116|P|pharmacist if you are allergic to it; or if you have any other||
9024|117|P|allergies. This product may contain inactive ingredients, which||
9024|118|P|can cause allergic reactions or other problems. Talk to your||
9024|119|P|pharmacist for more details.||
9024|120|P|   Before using this medication, tell your doctor or pharmacist||
9024|121|P|your medical history, especially of: kidney disease, heart rhythm||
9024|122|P|problems (such as slow/irregular heartbeat, second- or||
9024|123|P|third-degree atrioventricular block).||
9024|124|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9024|125|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9024|126|P|machinery, or do anything that needs alertness until you can do||
9024|127|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
9024|128|P|are using marijuana (cannabis).||
9024|129|P|   Before having surgery, tell your doctor or dentist about all||
9024|130|P|the products you use (including prescription drugs,||
9024|131|P|nonprescription drugs, and herbal products).||
9024|132|P|   If you are going to have an MRI test or cardioversion, tell||
9024|133|P|health care personnel that you are using this patch. Some patches||
9024|134|P|may contain metals that can cause serious burns during an MRI or||
9024|135|P|cardioversion. Ask your doctor whether you will need to remove||
9024|136|P|your patch before the procedure and apply a new patch afterward,||
9024|137|P|and how to do so properly.||
9024|138|P|   Contact lens wearers may need to use wetting eye drops since||
9024|139|P|this medication can cause dry eyes.||
9024|140|P|   Older adults may be more sensitive to the side effects of this||
9024|141|P|product, especially dizziness, or drowsiness. These side effects||
9024|142|P|may increase the risk of falling.||
9024|143|P|   During pregnancy, this medication should be used only when||
9024|144|P|clearly needed. Discuss the risks and benefits with your doctor.||
9024|145|P|   This drug passes into breast milk and may have undesirable||
9024|146|P|effects on a nursing infant. Consult your doctor before||
9024|147|P|breastfeeding.||
9024|148|B|||
9024|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9024|150|I|medications work or increase your risk for serious side effects.||
9024|151|I|This document does not contain all possible drug interactions.||
9024|152|I|Keep a list of all the products you use (including||
9024|153|I|prescription/nonprescription drugs and herbal products) and share||
9024|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
9024|155|I|the dosage of any medicines without your doctor's approval.||
9024|156|I|   Tell your doctor or pharmacist if you are taking other||
9024|157|I|products that cause drowsiness including alcohol, marijuana||
9024|158|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
9024|159|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
9024|160|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
9024|161|I|codeine).||
9024|162|I|   Check the labels on all your medicines (such as allergy or||
9024|163|I|cough-and-cold products) because they may contain ingredients||
9024|164|I|that cause drowsiness. Ask your pharmacist about using those||
9024|165|I|products safely.||
9024|166|I|   Some products have ingredients that could raise your blood||
9024|167|I|pressure. Tell your pharmacist what products you are using, and||
9024|168|I|ask how to use them safely (especially cough-and-cold products,||
9024|169|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
9024|170|B|||
9024|171|O|OVERDOSE:  This medication patch may be harmful if chewed or||
9024|172|O|swallowed. If someone has overdosed, remove the patch if||
9024|173|O|possible. For serious symptoms such as passing out or trouble||
9024|174|O|breathing, call 911. Otherwise, call a poison control center||
9024|175|O|right away. US residents can call 1-800-222-1222. Canada||
9024|176|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9024|177|O|include: severe dizziness/drowsiness, fainting, slow/irregular||
9024|178|O|heartbeat, slow/shallow breathing, seizures.||
9024|179|B|||
9024|180|N|NOTES:  Do not share this medication with others.||
9024|181|N|   Lifestyle changes such as stress reduction programs, exercise,||
9024|182|N|and dietary changes may increase the effectiveness of this||
9024|183|N|medicine. Talk to your doctor or pharmacist about lifestyle||
9024|184|N|changes that might benefit you.||
9024|185|N|   Check your blood pressure and pulse (heart rate) regularly||
9024|186|N|while using this medication. Learn how to monitor your own blood||
9024|187|N|pressure and pulse at home, and share the results with your||
9024|188|N|doctor.||
9024|189|B|||
9024|190|D|MISSED DOSE:  If you forget to replace a patch at the scheduled||
9024|191|D|time, replace it as soon as you remember. Call your doctor right||
9024|192|D|away if you are late replacing a patch by 3 or more days.||
9024|193|B|||
9024|194|R|STORAGE:  Store at room temperature. Keep all medications away||
9024|195|R|from children and pets.||
9024|196|R|   Do not flush medications down the toilet or pour them into a||
9024|197|R|drain unless instructed to do so. Properly discard this product||
9024|198|R|when it is expired or no longer needed (see also How to Use||
9024|199|R|section).||
9024|200|B|||
9024|201|A|Information last revised January 2025.||
9024|202|A|Copyright(c) 2025 First Databank, Inc.||
9024|203|B|||
9025|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9025|002|Z|does NOT have all possible information about this product. This||
9025|003|Z|information does not assure that this product is safe, effective,||
9025|004|Z|or appropriate for you. This information is not individual||
9025|005|Z|medical advice and does not substitute for the advice of your||
9025|006|Z|health care professional. Always ask your health care||
9025|007|Z|professional for complete information about this product and your||
9025|008|Z|specific health needs.||
9025|009|B|||
9025|010|T|BISMUTH SUBSALICYLATE - ORAL||
9025|011|F|(BIZ-muth SUB-sa-LIS-i-late)||
9025|012|B|||
9025|013|C|COMMON BRAND NAME(S): Pepto-Bismol, Pink Bismuth||
9025|014|B|||
9025|015|U|USES:  This medication is used to treat occasional upset stomach,||
9025|016|U|heartburn, and nausea. It is also used to treat diarrhea and help||
9025|017|U|prevent travelers' diarrhea. It works by helping to slow the||
9025|018|U|growth of bacteria that might be causing the diarrhea. This||
9025|019|U|product should not be used to self-treat diarrhea if you also||
9025|020|U|have a fever or blood/mucus in the stools. These could be signs||
9025|021|U|of a serious health condition. Consult your doctor promptly for||
9025|022|U|proper evaluation and treatment if you have these symptoms.||
9025|023|U|   This medication is used under a doctor's direction with other||
9025|024|U|medication to treat stomach ulcers caused by a certain bacteria||
9025|025|U|(Helicobacter pylori). Do not use this medication to self-treat||
9025|026|U|ulcers. Bismuth subsalicylate is a salicylate. Salicylates can||
9025|027|U|cause serious bleeding problems when used alone in patients with||
9025|028|U|ulcers.||
9025|029|U|   Check the ingredients on the label even if you have used the||
9025|030|U|product before. The manufacturer may have changed the||
9025|031|U|ingredients. Also, products with similar names may contain||
9025|032|U|different ingredients meant for different purposes. Taking the||
9025|033|U|wrong product could harm you.||
9025|034|B|||
9025|035|H|HOW TO USE:  Take this medication by mouth, usually as needed, as||
9025|036|H|directed by the product package or as directed by your doctor.||
9025|037|H|The dosage is based on your age, medical condition, and response||
9025|038|H|to treatment. Do not increase your dose or take this drug more||
9025|039|H|often than directed. Do not take more of this medication than||
9025|040|H|recommended for your age. There are many brands and forms of||
9025|041|H|bismuth subsalicylate available. Read the dosing instructions||
9025|042|H|carefully for each product because the dosing directions may be||
9025|043|H|different between products.||
9025|044|H|   If you are using the chewable tablets, chew each tablet well||
9025|045|H|and swallow. If you are using the liquid form of this medication,||
9025|046|H|shake the bottle well before each dose. Measure the dose||
9025|047|H|carefully using a special measuring device/cup. Do not use a||
9025|048|H|household spoon because you may not get the correct dose.||
9025|049|H|   This medication may react with other medications (such as||
9025|050|H|tetracycline antibiotics, chloroquine), preventing them from||
9025|051|H|being fully absorbed by your body. Talk with your doctor or||
9025|052|H|pharmacist about how to schedule your medications to prevent this||
9025|053|H|problem.||
9025|054|H|   If your doctor has directed you to use this medication daily,||
9025|055|H|use it regularly to get the most benefit from it. To help you||
9025|056|H|remember, take it at the same time(s) each day.||
9025|057|H|   Tell your doctor if your condition lasts or gets worse. If you||
9025|058|H|are taking this medication for diarrhea, tell your doctor if your||
9025|059|H|diarrhea lasts more than 2 days.||
9025|060|B|||
9025|061|S|SIDE EFFECTS:  Side effects from this medication are rare. The||
9025|062|S|most common side effects are darkening of the stools and/or||
9025|063|S|tongue. These effects are harmless and will disappear when you||
9025|064|S|stop the medication.||
9025|065|S|   If your doctor has directed you to use this medication,||
9025|066|S|remember that your doctor has judged that the benefit to you is||
9025|067|S|greater than the risk of side effects. Many people using this||
9025|068|S|medication do not have serious side effects.||
9025|069|S|   Vomiting/diarrhea that doesn't stop may result in dehydration.||
9025|070|S|Contact your doctor promptly if you notice any symptoms of||
9025|071|S|dehydration, such as unusual decreased urination, unusual dry||
9025|072|S|mouth/thirst, fast heartbeat, or dizziness/lightheadedness||
9025|073|S|   Tell your doctor right away if you have any serious side||
9025|074|S|effects, including: ringing ears, hearing loss.||
9025|075|S|   This drug may rarely cause serious (rarely fatal) bleeding||
9025|076|S|from the stomach or intestines. If you notice any of the||
9025|077|S|following unlikely but serious side effects, stop taking this||
9025|078|S|medication and consult your doctor or pharmacist right away:||
9025|079|S|stomach/abdominal pain that doesn't go away, vomit that looks||
9025|080|S|like coffee grounds, black/tarry/bloody stools.||
9025|081|S|   A very serious allergic reaction to this drug is rare.||
9025|082|S|However, get medical help right away if you notice any symptoms||
9025|083|S|of a serious allergic reaction, including: rash, itching/swelling||
9025|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9025|085|S|breathing.||
9025|086|S|   This is not a complete list of possible side effects. If you||
9025|087|S|notice other effects not listed above, contact your doctor or||
9025|088|S|pharmacist.||
9025|089|S|   In the US -||
9025|090|S|   Call your doctor for medical advice about side effects. You||
9025|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9025|092|S|www.fda.gov/medwatch.||
9025|093|S|   In Canada - Call your doctor for medical advice about side||
9025|094|S|effects. You may report side effects to Health Canada at||
9025|095|S|1-866-234-2345.||
9025|096|B|||
9025|097|P|PRECAUTIONS:  See also Uses section.||
9025|098|P|   Before taking bismuth subsalicylate, tell your doctor or||
9025|099|P|pharmacist if you are allergic to it; or if you are allergic to||
9025|100|P|aspirin, to salicylates (such as salsalate), or to NSAIDs (such||
9025|101|P|as ibuprofen, naproxen, celecoxib); or if you have any other||
9025|102|P|allergies. This product may contain inactive ingredients, which||
9025|103|P|can cause allergic reactions or other problems. Talk to your||
9025|104|P|pharmacist for more details.||
9025|105|P|   Before using this medication, tell your doctor or pharmacist||
9025|106|P|your medical history, especially of: bleeding problems (such as||
9025|107|P|hemophilia), bloody/black/tarry stools, gout.||
9025|108|P|   This medication may contain aspartame. If you have||
9025|109|P|phenylketonuria (PKU) or any other condition that requires you to||
9025|110|P|restrict your intake of aspartame (or phenylalanine), consult||
9025|111|P|your doctor or pharmacist about using this medication safely.||
9025|112|P|   Before having surgery, tell your doctors or dentist about all||
9025|113|P|the products you use (including prescription drugs,||
9025|114|P|nonprescription drugs, and herbal products).||
9025|115|P|   This drug contains an aspirin-like product (salicylate).||
9025|116|P|Children and teenagers younger than 18 years should not take this||
9025|117|P|product if they have chickenpox, flu, or any undiagnosed illness||
9025|118|P|or if they have recently received a vaccine. In these cases,||
9025|119|P|taking aspirin or aspirin-like products increases the risk of||
9025|120|P|Reye's syndrome, a rare but serious illness.||
9025|121|P|   Tell your doctor if you are pregnant or if you plan to become||
9025|122|P|pregnant. This medication may harm an unborn baby and cause||
9025|123|P|problems with normal labor/delivery. It is not recommended for||
9025|124|P|use in pregnancy from 20 weeks until delivery. If your doctor||
9025|125|P|decides that you need to use this medication between 20 and 30||
9025|126|P|weeks of pregnancy, you should use the lowest effective dose for||
9025|127|P|the shortest possible time. You should not use this medication||
9025|128|P|after 30 weeks of pregnancy. Discuss the risks and benefits with||
9025|129|P|your doctor.||
9025|130|P|   It is unknown if this medication passes into breast milk.||
9025|131|P|However, similar drugs pass into breast milk and may have||
9025|132|P|undesirable effects on a nursing infant. Consult your doctor||
9025|133|P|before breastfeeding.||
9025|134|B|||
9025|135|I|DRUG INTERACTIONS:  See also How to Use section.||
9025|136|I|   Drug interactions may change how your medications work or||
9025|137|I|increase your risk for serious side effects. This document does||
9025|138|I|not contain all possible drug interactions. Keep a list of all||
9025|139|I|the products you use (including prescription/nonprescription||
9025|140|I|drugs and herbal products) and share it with your doctor and||
9025|141|I|pharmacist. Do not start, stop, or change the dosage of any||
9025|142|I|medicines without your doctor's approval.||
9025|143|I|   Some products that may interact with this drug are: valproic||
9025|144|I|acid, carbonic anhydrase inhibitors (such as acetazolamide),||
9025|145|I|corticosteroids (such as prednisone), dichlorphenamide,||
9025|146|I|methotrexate.||
9025|147|I|   This medication may increase the risk of bleeding when taken||
9025|148|I|with other drugs that also may cause bleeding. Examples include||
9025|149|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
9025|150|I|dabigatran/enoxaparin/warfarin, among others.||
9025|151|I|   Check all prescription and nonprescription medicine labels||
9025|152|I|carefully since many contain pain relievers/fever reducers||
9025|153|I|(NSAIDs such as aspirin, ibuprofen, or naproxen) that are similar||
9025|154|I|to this drug and, if taken together, may increase your risk for||
9025|155|I|side effects. However, if your doctor has told you to take||
9025|156|I|low-dose aspirin to prevent heart attack or stroke (usually||
9025|157|I|81-162 milligrams a day), you should keep taking the aspirin||
9025|158|I|unless your doctor tells you not to. Ask your doctor or||
9025|159|I|pharmacist for more details.||
9025|160|I|   This medication may interfere with certain medical/lab tests||
9025|161|I|(such as x-rays of the intestines using contrast dye), possibly||
9025|162|I|causing false test results. Make sure lab personnel and all your||
9025|163|I|doctors know you use this drug.||
9025|164|B|||
9025|165|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9025|166|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9025|167|O|poison control center right away. US residents can call||
9025|168|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9025|169|O|Symptoms of overdose may include: ringing ears, hearing loss.||
9025|170|B|||
9025|171|N|NOTES:  If your doctor prescribes this medication for you, do not||
9025|172|N|share it with others.||
9025|173|N|   If you are taking this medication for diarrhea, drink plenty||
9025|174|N|of water to decrease the risk of dehydration. Consult your doctor||
9025|175|N|or pharmacist for more details.||
9025|176|B|||
9025|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9025|178|D|remember. If it is near the time of the next dose, skip the||
9025|179|D|missed dose. Take your next dose at the regular time. Do not||
9025|180|D|double the dose to catch up.||
9025|181|B|||
9025|182|R|STORAGE:  Store at room temperature away from light and moisture.||
9025|183|R|Do not freeze. Do not store in the bathroom. Keep all medications||
9025|184|R|away from children and pets.||
9025|185|R|   Do not flush medications down the toilet or pour them into a||
9025|186|R|drain unless instructed to do so. Properly discard this product||
9025|187|R|when it is expired or no longer needed. Consult your pharmacist||
9025|188|R|or local waste disposal company.||
9025|189|B|||
9025|190|A|Information last revised May 2024.||
9025|191|A|Copyright(c) 2025 First Databank, Inc.||
9025|192|B|||
9026|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9026|002|Z|does NOT have all possible information about this product. This||
9026|003|Z|information does not assure that this product is safe, effective,||
9026|004|Z|or appropriate for you. This information is not individual||
9026|005|Z|medical advice and does not substitute for the advice of your||
9026|006|Z|health care professional. Always ask your health care||
9026|007|Z|professional for complete information about this product and your||
9026|008|Z|specific health needs.||
9026|009|B|||
9026|010|T|ERGOTAMINE/CAFFEINE - ORAL||
9026|011|F|(er-GOT-a-meen/KAF-een)||
9026|012|B|||
9026|013|C|COMMON BRAND NAME(S): Cafergot||
9026|014|B|||
9026|015|W|WARNING:  This medication has rarely caused a serious lack of||
9026|016|W|blood flow to the arms/hands, or to the feet, or to the brain,||
9026|017|W|which could cause a stroke. The risk is increased when this||
9026|018|W|medication is taken with other drugs that can affect the removal||
9026|019|W|of ergotamine from your body. Examples include mifepristone,||
9026|020|W|telithromycin, certain antidepressants (such as nefazodone),||
9026|021|W|azole antifungals (such as ketoconazole, itraconazole),||
9026|022|W|cobicistat, macrolide antibiotics (such as clarithromycin,||
9026|023|W|erythromycin, troleandomycin), HIV protease inhibitors (such as||
9026|024|W|nelfinavir, indinavir), ritonavir, SSRIs (such as fluoxetine,||
9026|025|W|paroxetine, fluvoxamine), among others.||
9026|026|B|||
9026|027|U|USES:  This combination medication is used to treat or prevent||
9026|028|U|certain types of headaches (vascular headaches including migraine||
9026|029|U|and cluster headaches). Headache pain can sometimes be caused by||
9026|030|U|widened blood vessels in the head. Ergotamine works by narrowing||
9026|031|U|these widened blood vessels. Caffeine increases the absorption of||
9026|032|U|ergotamine and also narrows widened blood vessels.||
9026|033|B|||
9026|034|H|HOW TO USE:  Take this medication by mouth with or without food||
9026|035|H|as directed by your doctor, usually 2 tablets at the first sign||
9026|036|H|of headache, followed by 1 tablet every half hour until the||
9026|037|H|headache is relieved. Do not take more than 6 tablets per||
9026|038|H|headache attack or 10 tablets in a 7-day period.||
9026|039|H|   If your doctor has prescribed this medication to help prevent||
9026|040|H|certain types of headaches (such as cluster headaches), take this||
9026|041|H|medication exactly as directed by your doctor, usually for||
9026|042|H|short-term treatment (2 to 3 weeks).||
9026|043|H|   The dosage is based on your medical condition and response to||
9026|044|H|treatment. This medication works best if it is taken at the first||
9026|045|H|sign of the headache. If you wait until the headache has||
9026|046|H|worsened, the medication may not work as well.||
9026|047|H|   If you have a higher risk for heart problems (see||
9026|048|H|Precautions), your doctor may perform a heart exam before you||
9026|049|H|start taking this medication. He/she may also direct you to take||
9026|050|H|your first dose of this medication in the office/clinic to||
9026|051|H|monitor for serious side effects (such as chest pain). Talk to||
9026|052|H|your doctor for details.||
9026|053|H|   This medication is usually taken only as needed. It is not||
9026|054|H|meant for long-term daily use.||
9026|055|H|   Though it helps many people, this medication may sometimes||
9026|056|H|cause addiction. This risk may be higher if you have a substance||
9026|057|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
9026|058|H|Take this medication exactly as prescribed to lower the risk of||
9026|059|H|addiction. Ask your doctor or pharmacist for more details.||
9026|060|H|   If you are using drugs for migraine attacks on 10 or more days||
9026|061|H|each month, the drugs may actually make your headaches worse||
9026|062|H|(medication overuse headache). Do not use medications more often||
9026|063|H|or for longer than directed. Tell your doctor if you need to use||
9026|064|H|this medication more often, or if the medication is not working||
9026|065|H|as well, or if your headaches get worse.||
9026|066|B|||
9026|067|S|SIDE EFFECTS:  Nausea, vomiting, upset stomach, restlessness,||
9026|068|S|trouble sleeping, or dizziness may occur. If any of these effects||
9026|069|S|last or get worse, tell your doctor or pharmacist promptly.||
9026|070|S|   Remember that this medication has been prescribed because your||
9026|071|S|doctor has judged that the benefit to you is greater than the||
9026|072|S|risk of side effects. Many people using this medication do not||
9026|073|S|have serious side effects.||
9026|074|S|   This medication may raise your blood pressure. Check your||
9026|075|S|blood pressure regularly and tell your doctor if the results are||
9026|076|S|high.||
9026|077|S|   Tell your doctor right away if you have any serious side||
9026|078|S|effects, including: slow/fast/irregular heartbeat,||
9026|079|S|numbness/tingling in fingers/toes, blue fingers/toes/nails, cold||
9026|080|S|hands/feet, muscle pain/weakness, severe stomach/abdominal pain,||
9026|081|S|lower back pain, signs of kidney problems (such as change in the||
9026|082|S|amount of urine).||
9026|083|S|   Get medical help right away if you have any very serious side||
9026|084|S|effects, including: chest/jaw/left arm pain, confusion, trouble||
9026|085|S|speaking, vision changes, weakness on one side of the body.||
9026|086|S|   A very serious allergic reaction to this drug is rare.||
9026|087|S|However, get medical help right away if you notice any symptoms||
9026|088|S|of a serious allergic reaction, including: rash, itching/swelling||
9026|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9026|090|S|breathing.||
9026|091|S|   This is not a complete list of possible side effects. If you||
9026|092|S|notice other effects not listed above, contact your doctor or||
9026|093|S|pharmacist.||
9026|094|S|   In the US -||
9026|095|S|   Call your doctor for medical advice about side effects. You||
9026|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9026|097|S|www.fda.gov/medwatch.||
9026|098|S|   In Canada - Call your doctor for medical advice about side||
9026|099|S|effects. You may report side effects to Health Canada at||
9026|100|S|1-866-234-2345.||
9026|101|B|||
9026|102|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9026|103|P|pharmacist if you are allergic to ergotamine or caffeine; or to||
9026|104|P|other ergot alkaloids (such as dihydroergotamine); or if you have||
9026|105|P|any other allergies. This product may contain inactive||
9026|106|P|ingredients (such as tartrazine found in some brands), which can||
9026|107|P|cause allergic reactions or other problems. Talk to your||
9026|108|P|pharmacist for more details.||
9026|109|P|   Before using this medication, tell your doctor or pharmacist||
9026|110|P|your medical history, especially of: blood circulation problems||
9026|111|P|(for example, in your legs, arms/hands, or stomach), certain||
9026|112|P|types of headaches (hemiplegic or basilar migraine), heart||
9026|113|P|problems (such as chest pain, irregular heartbeat, previous heart||
9026|114|P|attack), kidney disease, liver disease, personal or family||
9026|115|P|history of a substance use disorder (such as overuse of or||
9026|116|P|addiction to drugs/alcohol), stroke or "mini-stroke" (transient||
9026|117|P|ischemic attack).||
9026|118|P|   Certain conditions can increase your risk for heart problems.||
9026|119|P|Tell your doctor if you have any of these conditions, including:||
9026|120|P|high blood pressure, high cholesterol, diabetes, family history||
9026|121|P|of heart disease, overweight, postmenopausal (women), age more||
9026|122|P|than 40 years (men).||
9026|123|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9026|124|P|can make you more dizzy. Do not drive, use machinery, or do||
9026|125|P|anything that needs alertness until you can do it safely. Limit||
9026|126|P|alcoholic beverages. Talk to your doctor if you are using||
9026|127|P|marijuana (cannabis). Remember that alcohol may cause headaches.||
9026|128|P|   Using tobacco/nicotine products while using this medication||
9026|129|P|can increase the risk of serious side effects such as heart||
9026|130|P|problems and decreased blood flow to the brain/hands/feet. Do not||
9026|131|P|use tobacco while taking this medication. If you smoke, talk to||
9026|132|P|your doctor about how to stop smoking.||
9026|133|P|   Before having surgery or certain medical procedures (such as a||
9026|134|P|heart stress test or a procedure to restore a normal heart rhythm||
9026|135|P|if you have an unusually fast heartbeat), tell your doctor or||
9026|136|P|dentist that you use this medication and about all the products||
9026|137|P|you use (including prescription drugs, nonprescription drugs, and||
9026|138|P|herbal products).||
9026|139|P|   This medication must not be used during pregnancy. It may harm||
9026|140|P|an unborn baby. Discuss the use of reliable forms of birth||
9026|141|P|control (such as condoms, birth control pills) with your doctor.||
9026|142|P|If you become pregnant or think you may be pregnant, tell your||
9026|143|P|doctor right away.||
9026|144|P|   This drug passes into breast milk and may have undesirable||
9026|145|P|effects on a nursing infant. Consult your doctor before||
9026|146|P|breastfeeding.||
9026|147|B|||
9026|148|I|DRUG INTERACTIONS:  See also Warning section.||
9026|149|I|   Drug interactions may change how your medications work or||
9026|150|I|increase your risk for serious side effects. This document does||
9026|151|I|not contain all possible drug interactions. Keep a list of all||
9026|152|I|the products you use (including prescription/nonprescription||
9026|153|I|drugs and herbal products) and share it with your doctor and||
9026|154|I|pharmacist. Do not start, stop, or change the dosage of any||
9026|155|I|medicines without your doctor's approval.||
9026|156|I|   If you also take "triptan" migraine drugs (such as||
9026|157|I|sumatriptan, rizatriptan), you will need to separate your triptan||
9026|158|I|dose from your dose of this medication to lessen the chance of||
9026|159|I|serious side effects. Ask your doctor how long you should wait||
9026|160|I|between your doses of these drugs.||
9026|161|I|   Some products may contain caffeine or ingredients that could||
9026|162|I|raise your heart rate or blood pressure. Certain beverages (such||
9026|163|I|as coffee, colas, energy drinks) may also contain caffeine. Tell||
9026|164|I|your pharmacist what products you are using, and ask how to use||
9026|165|I|them safely (especially cough-and-cold products, bronchodilators,||
9026|166|I|stimulants, diet aids, or other headache medications).||
9026|167|I|   This medication may interfere with certain medical/lab tests||
9026|168|I|(such as dipyridamole-thallium imaging tests, urine||
9026|169|I|catecholamine/5-HIAA levels), possibly causing false test||
9026|170|I|results. Make sure lab personnel and all your doctors know you||
9026|171|I|use this drug.||
9026|172|B|||
9026|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9026|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9026|175|O|poison control center right away. US residents can call||
9026|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9026|177|O|Symptoms of overdose may include: nausea/vomiting,||
9026|178|O|numbness/tingling in the fingers/toes, chest pain, muscle||
9026|179|O|pain/weakness.||
9026|180|B|||
9026|181|N|NOTES:  Do not share this medication with others.||
9026|182|N|   Certain foods, beverages, or food additives (such as red wine,||
9026|183|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
9026|184|N|patterns such as irregular eating/sleeping habits or stress may||
9026|185|N|bring on a migraine headache. Avoiding these "triggers" may help||
9026|186|N|lessen migraine attacks. Consult your doctor for more details.||
9026|187|B|||
9026|188|D|MISSED DOSE:  Not applicable.||
9026|189|B|||
9026|190|R|STORAGE:  Store at room temperature away from light and moisture.||
9026|191|R|Do not store in the bathroom. Keep all medications away from||
9026|192|R|children and pets.||
9026|193|R|   Do not flush medications down the toilet or pour them into a||
9026|194|R|drain unless instructed to do so. Properly discard this product||
9026|195|R|when it is expired or no longer needed. Consult your pharmacist||
9026|196|R|or local waste disposal company.||
9026|197|B|||
9026|198|A|Information last revised May 2025.||
9026|199|A|Copyright(c) 2025 First Databank, Inc.||
9026|200|B|||
9027|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9027|002|Z|does NOT have all possible information about this product. This||
9027|003|Z|information does not assure that this product is safe, effective,||
9027|004|Z|or appropriate for you. This information is not individual||
9027|005|Z|medical advice and does not substitute for the advice of your||
9027|006|Z|health care professional. Always ask your health care||
9027|007|Z|professional for complete information about this product and your||
9027|008|Z|specific health needs.||
9027|009|B|||
9027|010|T|ESTRADIOL SEMIWEEKLY - TRANSDERMAL||
9027|011|F|(ES-tra-DYE-ol)||
9027|012|B|||
9027|013|C|COMMON BRAND NAME(S): Alora, Estraderm, Minivelle, Vivelle||
9027|014|B|||
9027|015|W|WARNING:  Estrogens, either used alone or with another hormone||
9027|016|W|(progestin), have rarely caused very serious side effects.||
9027|017|W|Discuss the risks and benefits of hormone treatment with your||
9027|018|W|doctor. Estrogens should not be used to prevent heart disease or||
9027|019|W|dementia.||
9027|020|W|   Estrogens can increase the risk of cancer of the uterus||
9027|021|W|(endometrial cancer). Taking a progestin as directed by your||
9027|022|W|doctor can help decrease this risk. Tell your doctor right away||
9027|023|W|if you have any unusual vaginal bleeding.||
9027|024|W|   In postmenopausal women, estrogens, taken with or without a||
9027|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
9027|026|W|stroke, dementia, and serious blood clots. When used along with a||
9027|027|W|progestin, estrogens also increase the risk of heart disease||
9027|028|W|(such as heart attacks).||
9027|029|W|   The risk for serious side effects may depend on the dose of||
9027|030|W|estrogen and the length of time it is used. This medication||
9027|031|W|should be used at the lowest effective dose and for the shortest||
9027|032|W|amount of time. Discuss the use of this medication with your||
9027|033|W|doctor and check with him/her regularly (for example, every 3 to||
9027|034|W|6 months) to see if you still need to use this medication. If you||
9027|035|W|will be using this medication long-term, you should have regular||
9027|036|W|complete physical exams (for example, once a year) as directed by||
9027|037|W|your doctor. See also Notes section.||
9027|038|B|||
9027|039|U|USES:  This medication is a hormone (estrogen). It is used by||
9027|040|U|women to help reduce symptoms of menopause (such as hot flashes,||
9027|041|U|vaginal dryness). These symptoms are caused by the body making||
9027|042|U|less estrogen. If you are using this medication to treat symptoms||
9027|043|U|only in and around the vagina, products applied directly inside||
9027|044|U|the vagina should be considered before medications that are taken||
9027|045|U|by mouth, absorbed through the skin, or injected. This medication||
9027|046|U|may also be used by women who are not able to produce enough||
9027|047|U|estrogen (for example, due to hypogonadism, primary ovarian||
9027|048|U|failure).||
9027|049|U|   Certain estrogen products may also be used by women after||
9027|050|U|menopause to prevent bone loss (osteoporosis). However, there are||
9027|051|U|other medications (such as raloxifene, bisphosphonates including||
9027|052|U|alendronate) that are also effective in preventing bone loss and||
9027|053|U|may be safer. These medications should be considered for use||
9027|054|U|before estrogen treatment.||
9027|055|B|||
9027|056|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9027|057|H|from your pharmacist before you start using this medication and||
9027|058|H|each time you get a refill. If you have any questions, ask your||
9027|059|H|doctor or pharmacist.||
9027|060|H|   Peel off the backing from the patch and apply the patch to a||
9027|061|H|clean, dry area of the body as directed. This patch should only||
9027|062|H|be applied to certain areas of the body. Different brands of||
9027|063|H|patches are applied to different areas of the body. If you have||
9027|064|H|any questions about where to apply the patch, ask your doctor or||
9027|065|H|pharmacist. Press the patch firmly in place for about 10 seconds||
9027|066|H|to make sure it stays on. Do not apply the patch on the breast or||
9027|067|H|on oily, broken, or irritated skin. Avoid applying the patch to||
9027|068|H|areas of the skin where it might be easily rubbed off (such as||
9027|069|H|the waistline). Use this medication as directed by your doctor.||
9027|070|H|The patch is usually replaced twice a week (every 3 to 4 days).||
9027|071|H|Follow the dosing schedule carefully.||
9027|072|H|   The dosage is based on your medical condition and response to||
9027|073|H|treatment.||
9027|074|H|   When replacing your patch, make sure to apply the new patch to||
9027|075|H|a different area. Wait at least 1 week before applying a patch to||
9027|076|H|the same area. Fold the old patch in half with the sticky side||
9027|077|H|together and throw away in the trash away from children and pets.||
9027|078|H|Do not flush the patch down the toilet.||
9027|079|H|   If a patch falls off, reapply it to a different area. If the||
9027|080|H|patch does not stick completely, then apply a new patch and wear||
9027|081|H|it for the rest of the scheduled period. Do not wear 2 patches at||
9027|082|H|the same time.||
9027|083|H|   Use this medication regularly to get the most benefit from it.||
9027|084|H|To help you remember, change the patch on the same days each||
9027|085|H|week. Mark your calendar with a reminder.||
9027|086|H|   Tell your doctor if your condition does not get better or if||
9027|087|H|it gets worse.||
9027|088|B|||
9027|089|S|SIDE EFFECTS:  See also Warning section.||
9027|090|S|   Skin redness/irritation at the application site,||
9027|091|S|nausea/vomiting, bloating, breast tenderness, headache, or weight||
9027|092|S|changes may occur. If any of these effects last or get worse,||
9027|093|S|tell your doctor or pharmacist promptly.||
9027|094|S|   Remember that this medication has been prescribed because your||
9027|095|S|doctor has judged that the benefit to you is greater than the||
9027|096|S|risk of side effects. Many people using this medication do not||
9027|097|S|have serious side effects.||
9027|098|S|   Tell your doctor right away if you have any serious side||
9027|099|S|effects, including: nausea/vomiting that doesn't stop,||
9027|100|S|mental/mood changes (such as depression, memory loss), breast||
9027|101|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
9027|102|S|bleeding, prolonged/recurrent bleeding), increased or new vaginal||
9027|103|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
9027|104|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
9027|105|S|increased thirst/urination.||
9027|106|S|   This medication may rarely cause serious (sometimes fatal)||
9027|107|S|problems from blood clots (such as heart attack, stroke, blood||
9027|108|S|clots in the lungs or legs). Get medical help right away if you||
9027|109|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
9027|110|S|headaches, weakness on one side of the body, confusion, trouble||
9027|111|S|speaking, sudden vision changes, pain/swelling/warmth in the||
9027|112|S|groin/calf, shortness of breath/rapid breathing, sudden||
9027|113|S|dizziness/fainting.||
9027|114|S|   A very serious allergic reaction to this product is rare.||
9027|115|S|However, get medical help right away if you notice any symptoms||
9027|116|S|of a serious allergic reaction, including: rash, itching/swelling||
9027|117|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9027|118|S|breathing.||
9027|119|S|   This is not a complete list of possible side effects. If you||
9027|120|S|notice other effects not listed above, contact your doctor or||
9027|121|S|pharmacist.||
9027|122|S|   In the US -||
9027|123|S|   Call your doctor for medical advice about side effects. You||
9027|124|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9027|125|S|www.fda.gov/medwatch.||
9027|126|S|   In Canada - Call your doctor for medical advice about side||
9027|127|S|effects. You may report side effects to Health Canada at||
9027|128|S|1-866-234-2345.||
9027|129|B|||
9027|130|P|PRECAUTIONS:  Before using estradiol, tell your doctor or||
9027|131|P|pharmacist if you are allergic to it; or if you have any other||
9027|132|P|allergies. This product may contain inactive ingredients, which||
9027|133|P|can cause allergic reactions or other problems. Talk to your||
9027|134|P|pharmacist for more details.||
9027|135|P|   Before using this medication, tell your doctor or pharmacist||
9027|136|P|your medical history, especially of: vaginal bleeding of unknown||
9027|137|P|cause, certain cancers (such as breast cancer, cancer of the||
9027|138|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
9027|139|P|heart attack), liver disease, kidney disease, family medical||
9027|140|P|history (especially breast lumps, cancer, blood clots), family or||
9027|141|P|personal history of a certain swelling disorder (angioedema),||
9027|142|P|blood clotting disorders (such as protein C or protein S||
9027|143|P|deficiency), high blood pressure, diabetes, high||
9027|144|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
9027|145|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
9027|146|P|calcium in the blood), a certain hormone problem||
9027|147|P|(hypoparathyroidism), uterus problems (such as fibroids,||
9027|148|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
9027|149|P|headaches, a certain blood disorder (porphyria), mental/mood||
9027|150|P|disorders (such as dementia, depression).||
9027|151|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
9027|152|P|further increases your risk of stroke, blood clots, high blood||
9027|153|P|pressure, and heart attack, especially in women older than 35.||
9027|154|P|   Tell your doctor if you just had or will be having surgery, or||
9027|155|P|if you will be confined to a chair or bed for a long time (such||
9027|156|P|as a long plane flight). These conditions increase your risk of||
9027|157|P|getting blood clots, especially if you are taking an estrogen||
9027|158|P|product. You may need to stop this medication for a time or take||
9027|159|P|special precautions.||
9027|160|P|   If you are going to have an MRI test, tell testing personnel||
9027|161|P|that you are using this patch. Some patches may contain metals||
9027|162|P|that can cause serious burns during an MRI. Ask your doctor||
9027|163|P|whether you will need to remove your patch before the test and||
9027|164|P|apply a new patch afterward, and how to do so properly.||
9027|165|P|   This medication may cause blotchy, dark areas on your face and||
9027|166|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
9027|167|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
9027|168|P|wear protective clothing when outdoors.||
9027|169|P|   If you are nearsighted or wear contact lenses, you may develop||
9027|170|P|vision problems or trouble wearing your contact lenses. Contact||
9027|171|P|your eye doctor if these problems occur.||
9027|172|P|   Children may be more sensitive to the side effects of this||
9027|173|P|drug. It may affect their growth/development. Discuss the||
9027|174|P|possible effects of this medication with the doctor, and monitor||
9027|175|P|your child's growth periodically.||
9027|176|P|   This medication should not be used during pregnancy. If you||
9027|177|P|become pregnant or think you may be pregnant, tell your doctor||
9027|178|P|right away.||
9027|179|P|   This medication passes into breast milk. Consult your doctor||
9027|180|P|before breastfeeding.||
9027|181|B|||
9027|182|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9027|183|I|medications work or increase your risk for serious side effects.||
9027|184|I|This document does not contain all possible drug interactions.||
9027|185|I|Keep a list of all the products you use (including||
9027|186|I|prescription/nonprescription drugs and herbal products) and share||
9027|187|I|it with your doctor and pharmacist. Do not start, stop, or change||
9027|188|I|the dosage of any medicines without your doctor's approval.||
9027|189|I|   Some products that may interact with this drug include:||
9027|190|I|aromatase inhibitors (such as anastrozole, exemestane,||
9027|191|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
9027|192|I|tamoxifen, toremifene, tranexamic acid.||
9027|193|I|   This medication may interfere with certain lab tests, possibly||
9027|194|I|causing false test results. Make sure lab personnel and all your||
9027|195|I|doctors know you use this drug.||
9027|196|B|||
9027|197|O|OVERDOSE:  This medication patch may be harmful if chewed or||
9027|198|O|swallowed. If someone has overdosed, remove the patch if||
9027|199|O|possible. For serious symptoms such as passing out or trouble||
9027|200|O|breathing, call 911. Otherwise, call a poison control center||
9027|201|O|right away. US residents can call 1-800-222-1222. Canada||
9027|202|O|residents can call 1-844-764-7669.||
9027|203|B|||
9027|204|N|NOTES:  Do not share this medication with others.||
9027|205|N|   Regular complete physical exams which include lab and/or||
9027|206|N|medical tests (such as blood pressure, breast exam/mammogram,||
9027|207|N|pelvic exam, Pap smear) should be done while you are using this||
9027|208|N|medication. Follow your doctor's instructions for examining your||
9027|209|N|breasts, and report any lumps right away. Keep all medical and||
9027|210|N|lab appointments. Consult your doctor for more details.||
9027|211|N|   Preventing or controlling high blood pressure, high||
9027|212|N|cholesterol, and diabetes can help to reduce your chances of||
9027|213|N|heart disease and stroke. Lifestyle changes that can help to||
9027|214|N|control or prevent these diseases include reducing stress, eating||
9027|215|N|a low fat/salt diet, losing weight if overweight, exercising||
9027|216|N|regularly, and stopping smoking. Keep your mind active with||
9027|217|N|mental exercises (such as reading, solving crossword puzzles) to||
9027|218|N|help prevent dementia. Talk to your doctor about lifestyle||
9027|219|N|changes that might benefit you.||
9027|220|N|   Lifestyle changes that may help reduce hot flashes include||
9027|221|N|stopping smoking, dressing lightly or in layers,||
9027|222|N|avoiding/limiting certain foods (spicy foods, caffeine, alcohol),||
9027|223|N|reducing stress, and exercising regularly.||
9027|224|N|   Lifestyle changes that help promote healthy bones include||
9027|225|N|increasing weight-bearing exercise, stopping smoking, limiting||
9027|226|N|alcohol, and eating well-balanced meals that contain adequate||
9027|227|N|calcium and vitamin D. Since you may also need to take calcium||
9027|228|N|and vitamin D supplements and make lifestyle changes, consult||
9027|229|N|your doctor for specific advice.||
9027|230|B|||
9027|231|D|MISSED DOSE:  If you forget to replace a patch at the scheduled||
9027|232|D|time, replace it as soon as you remember. Do not use more than||
9027|233|D|one patch at a time.||
9027|234|B|||
9027|235|R|STORAGE:  Store at room temperature. Do not remove the patch from||
9027|236|R|the pouch until ready for use. Keep all medications away from||
9027|237|R|children and pets.||
9027|238|R|   Do not flush medications down the toilet or pour them into a||
9027|239|R|drain unless instructed to do so. Properly discard this product||
9027|240|R|when it is expired or no longer needed (See How to Use section).||
9027|241|B|||
9027|242|A|Information last revised October 2024.||
9027|243|A|Copyright(c) 2025 First Databank, Inc.||
9027|244|B|||
9028|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9028|002|Z|does NOT have all possible information about this product. This||
9028|003|Z|information does not assure that this product is safe, effective,||
9028|004|Z|or appropriate for you. This information is not individual||
9028|005|Z|medical advice and does not substitute for the advice of your||
9028|006|Z|health care professional. Always ask your health care||
9028|007|Z|professional for complete information about this product and your||
9028|008|Z|specific health needs.||
9028|009|B|||
9028|010|T|PYRAZINAMIDE - ORAL||
9028|011|F|(pir-uh-ZIN-uh-mide)||
9028|012|B|||
9028|013|U|USES:  Pyrazinamide is used with other medications to treat||
9028|014|U|tuberculosis (TB). It is an antibiotic and works by stopping the||
9028|015|U|growth of bacteria.||
9028|016|U|   This antibiotic treats only bacterial infections. It will not||
9028|017|U|work for viral infections (such as common cold, flu). Using any||
9028|018|U|antibiotic when it is not needed can cause it to not work for||
9028|019|U|future infections.||
9028|020|B|||
9028|021|H|HOW TO USE:  Take this medication by mouth with or without food||
9028|022|H|as directed by your doctor, usually once daily or twice weekly.||
9028|023|H|   The dosage is based on your age, weight, medical condition,||
9028|024|H|and response to treatment.||
9028|025|H|   For the best effect, take this antibiotic at evenly spaced||
9028|026|H|times. If you are taking this medication daily, take it at the||
9028|027|H|same time each day. If you are taking this medication on a weekly||
9028|028|H|schedule, take it on the same days and time each week. Mark your||
9028|029|H|calendar with a reminder.||
9028|030|H|   Continue to take this medication (and other TB medications)||
9028|031|H|until the full prescribed amount is finished, even if symptoms||
9028|032|H|disappear. Stopping the medication too early or skipping doses||
9028|033|H|may result in a return of the infection and cause the infection||
9028|034|H|to be more difficult to treat (resistant).||
9028|035|H|   Tell your doctor if your condition lasts or gets worse.||
9028|036|B|||
9028|037|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, or mild||
9028|038|S|muscle/joint pain may occur. If any of these effects last or get||
9028|039|S|worse, tell your doctor or pharmacist promptly.||
9028|040|S|   Remember that this medication has been prescribed because your||
9028|041|S|doctor has judged that the benefit to you is greater than the||
9028|042|S|risk of side effects. Many people using this medication do not||
9028|043|S|have serious side effects.||
9028|044|S|   Tell your doctor right away if you have any serious side||
9028|045|S|effects, including: symptoms of liver disease (such as||
9028|046|S|nausea/vomiting that doesn't stop, unusual tiredness/weakness,||
9028|047|S|severe stomach/abdominal pain, yellowing eyes/skin, dark urine),||
9028|048|S|painful/swollen joints, signs of kidney problems (such as change||
9028|049|S|in the amount of urine), easy bleeding/bruising, fast heartbeat.||
9028|050|S|   A very serious allergic reaction to this drug is rare.||
9028|051|S|However, get medical help right away if you notice any symptoms||
9028|052|S|of a serious allergic reaction, including: fever that doesn't go||
9028|053|S|away, new or worsening lymph node swelling, rash,||
9028|054|S|itching/swelling (especially of the face/tongue/throat), severe||
9028|055|S|dizziness, trouble breathing.||
9028|056|S|   This is not a complete list of possible side effects. If you||
9028|057|S|notice other effects not listed above, contact your doctor or||
9028|058|S|pharmacist.||
9028|059|S|   In the US -||
9028|060|S|   Call your doctor for medical advice about side effects. You||
9028|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9028|062|S|www.fda.gov/medwatch.||
9028|063|S|   In Canada - Call your doctor for medical advice about side||
9028|064|S|effects. You may report side effects to Health Canada at||
9028|065|S|1-866-234-2345.||
9028|066|B|||
9028|067|P|PRECAUTIONS:  Before taking pyrazinamide, tell your doctor or||
9028|068|P|pharmacist if you are allergic to it; or if you have any other||
9028|069|P|allergies. This product may contain inactive ingredients, which||
9028|070|P|can cause allergic reactions or other problems. Talk to your||
9028|071|P|pharmacist for more details.||
9028|072|P|   Before using this medication, tell your doctor or pharmacist||
9028|073|P|your medical history, especially of: liver disease, kidney||
9028|074|P|disease, diabetes, gout, high uric acid level in the blood,||
9028|075|P|alcohol use.||
9028|076|P|   Before having surgery, tell your doctor or dentist about all||
9028|077|P|the products you use (including prescription drugs,||
9028|078|P|nonprescription drugs, and herbal products).||
9028|079|P|   Alcohol may increase the risk of liver disease. Avoid||
9028|080|P|alcoholic beverages while using this medication.||
9028|081|P|   Pyrazinamide may cause live bacterial vaccines (such as||
9028|082|P|typhoid vaccine) to not work well. Tell your health care||
9028|083|P|professional that you are using pyrazinamide before having any||
9028|084|P|immunizations/vaccinations.||
9028|085|P|   During pregnancy, this medication should be used only when||
9028|086|P|clearly needed. Discuss the risks and benefits with your doctor.||
9028|087|P|   This medication passes into breast milk. Consult your doctor||
9028|088|P|before breastfeeding.||
9028|089|B|||
9028|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9028|091|I|medications work or increase your risk for serious side effects.||
9028|092|I|This document does not contain all possible drug interactions.||
9028|093|I|Keep a list of all the products you use (including||
9028|094|I|prescription/nonprescription drugs and herbal products) and share||
9028|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
9028|096|I|the dosage of any medicines without your doctor's approval.||
9028|097|I|   This medication may interfere with certain lab tests (such as||
9028|098|I|urine ketone tests), possibly causing false test results. Make||
9028|099|I|sure lab personnel and all your doctors know you use this drug.||
9028|100|B|||
9028|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9028|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9028|103|O|poison control center right away. US residents can call||
9028|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9028|105|B|||
9028|106|N|NOTES:  Do not share this medication with others.||
9028|107|N|   Lab and/or medical tests (such as sputum test, kidney/liver||
9028|108|N|function, uric acid levels, complete blood count) should be done||
9028|109|N|while you are taking this medication. Keep all medical and lab||
9028|110|N|appointments. Consult your doctor for more details.||
9028|111|B|||
9028|112|D|MISSED DOSE:  It is important to take each dose of this||
9028|113|D|medication as scheduled. If you are taking this medication daily||
9028|114|D|and miss a dose, take it as soon as you remember. If it is near||
9028|115|D|the time of the next dose, skip the missed dose. Take your next||
9028|116|D|dose at the regular time. Do not double the dose to catch up.||
9028|117|D|   If you are taking this drug on a weekly schedule and miss a||
9028|118|D|dose, take it as soon as you remember. If you don't remember||
9028|119|D|until the next day or later, ask your doctor or pharmacist right||
9028|120|D|away for a new dosing schedule. Do not double the dose to catch||
9028|121|D|up.||
9028|122|B|||
9028|123|R|STORAGE:  Store at room temperature away from light and moisture.||
9028|124|R|Do not store in the bathroom. Keep all medications away from||
9028|125|R|children and pets.||
9028|126|R|   Do not flush medications down the toilet or pour them into a||
9028|127|R|drain unless instructed to do so. Properly discard this product||
9028|128|R|when it is expired or no longer needed. Consult your pharmacist||
9028|129|R|or local waste disposal company.||
9028|130|B|||
9028|131|A|Information last revised October 2024.||
9028|132|A|Copyright(c) 2025 First Databank, Inc.||
9028|133|B|||
9029|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9029|002|Z|does NOT have all possible information about this product. This||
9029|003|Z|information does not assure that this product is safe, effective,||
9029|004|Z|or appropriate for you. This information is not individual||
9029|005|Z|medical advice and does not substitute for the advice of your||
9029|006|Z|health care professional. Always ask your health care||
9029|007|Z|professional for complete information about this product and your||
9029|008|Z|specific health needs.||
9029|009|B|||
9029|010|T|METHSUXIMIDE - ORAL||
9029|011|F|(meth-SUX-eh-mide)||
9029|012|B|||
9029|013|C|COMMON BRAND NAME(S): Celontin||
9029|014|B|||
9029|015|U|USES:  This medication is used alone or with other medications to||
9029|016|U|prevent and control a certain type of seizure (absence or petit||
9029|017|U|mal seizure). It works by controlling the abnormal electrical||
9029|018|U|activity in the brain that occurs during a seizure.||
9029|019|B|||
9029|020|H|HOW TO USE:  Read the Medication Guide provided by your||
9029|021|H|pharmacist before you start taking this medication and each time||
9029|022|H|you get a refill. If you have any questions, ask your doctor or||
9029|023|H|pharmacist.||
9029|024|H|   Take this medication by mouth with or without food as directed||
9029|025|H|by your doctor, usually once or twice daily.||
9029|026|H|   Dosage is based on your medical condition and response to||
9029|027|H|treatment.||
9029|028|H|   It is very important to follow your doctor's dosing||
9029|029|H|instructions exactly. Your doctor will start you on a low dose||
9029|030|H|and slowly increase your dose. It may take several weeks or||
9029|031|H|months to reach the best dose for you and to get the full benefit||
9029|032|H|from this medication. Use this medication regularly in order to||
9029|033|H|get the most benefit from it. To help you remember, take it at||
9029|034|H|the same time(s) each day.||
9029|035|H|   Do not stop taking this medication without consulting your||
9029|036|H|doctor. Some conditions may become worse when the drug is||
9029|037|H|suddenly stopped. Your dose may need to be gradually decreased.||
9029|038|H|   Tell your doctor if your condition does not get better or if||
9029|039|H|it gets worse.||
9029|040|B|||
9029|041|S|SIDE EFFECTS:  Drowsiness, dizziness, stomach/abdominal pain,||
9029|042|S|loss of appetite, nausea, vomiting, weight loss, diarrhea,||
9029|043|S|headache, or loss of coordination may occur. If any of these||
9029|044|S|effects last or get worse, tell your doctor or pharmacist||
9029|045|S|promptly.||
9029|046|S|   Remember that this medication has been prescribed because your||
9029|047|S|doctor has judged that the benefit to you is greater than the||
9029|048|S|risk of side effects. Many people using this medication do not||
9029|049|S|have serious side effects.||
9029|050|S|   A small number of people who take anticonvulsants for any||
9029|051|S|condition (such as seizure, bipolar disorder, pain) may||
9029|052|S|experience depression, suicidal thoughts/attempts, or other||
9029|053|S|mental/mood problems. Tell your doctor right away if you or your||
9029|054|S|family/caregiver notice any unusual/sudden changes in your mood,||
9029|055|S|thoughts, or behavior including signs of depression, suicidal||
9029|056|S|thoughts/attempts, thoughts about harming yourself.||
9029|057|S|   Tell your doctor right away if you have any serious side||
9029|058|S|effects, including: signs of infection (such as sore throat that||
9029|059|S|doesn't go away, fever, chills), aching swollen joints, rash on||
9029|060|S|nose and cheeks, severe tiredness, easy bruising/bleeding, rapid||
9029|061|S|breathing.||
9029|062|S|   A very serious allergic reaction to this drug is rare.||
9029|063|S|However, get medical help right away if you notice any symptoms||
9029|064|S|of a serious allergic reaction, including: rash, itching/swelling||
9029|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9029|066|S|breathing.||
9029|067|S|   This is not a complete list of possible side effects. If you||
9029|068|S|notice other effects not listed above, contact your doctor or||
9029|069|S|pharmacist.||
9029|070|S|   In the US -||
9029|071|S|   Call your doctor for medical advice about side effects. You||
9029|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9029|073|S|www.fda.gov/medwatch.||
9029|074|S|   In Canada - Call your doctor for medical advice about side||
9029|075|S|effects. You may report side effects to Health Canada at||
9029|076|S|1-866-234-2345.||
9029|077|B|||
9029|078|P|PRECAUTIONS:  Before taking methsuximide, tell your doctor or||
9029|079|P|pharmacist if you are allergic to it; or to ethosuximide; or if||
9029|080|P|you have any other allergies. This product may contain inactive||
9029|081|P|ingredients, which can cause allergic reactions or other||
9029|082|P|problems. Talk to your pharmacist for more details.||
9029|083|P|   Before using this medication, tell your doctor or pharmacist||
9029|084|P|your medical history, especially of: liver problems, kidney||
9029|085|P|problems.||
9029|086|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9029|087|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9029|088|P|machinery, or do anything that needs alertness until you can do||
9029|089|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
9029|090|P|are using marijuana (cannabis).||
9029|091|P|   During pregnancy, this medication should be used only when||
9029|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
9029|093|P|   It is unknown if this medication passes into breast milk.||
9029|094|P|Consult your doctor before breastfeeding.||
9029|095|B|||
9029|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9029|097|I|medications work or increase your risk for serious side effects.||
9029|098|I|This document does not contain all possible drug interactions.||
9029|099|I|Keep a list of all the products you use (including||
9029|100|I|prescription/nonprescription drugs and herbal products) and share||
9029|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
9029|102|I|the dosage of any medicines without your doctor's approval.||
9029|103|I|   A product that may interact with this drug is: orlistat.||
9029|104|I|   Tell your doctor or pharmacist if you are taking other||
9029|105|I|products that cause drowsiness, including alcohol, marijuana||
9029|106|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
9029|107|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
9029|108|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
9029|109|I|codeine).||
9029|110|I|   Check the labels on all your medicines (such as allergy or||
9029|111|I|cough-and-cold products) because they may contain ingredients||
9029|112|I|that cause drowsiness. Ask your pharmacist about using those||
9029|113|I|products safely.||
9029|114|B|||
9029|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9029|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9029|117|O|poison control center right away. US residents can call||
9029|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9029|119|O|Symptoms of overdose may include: slow/shallow breathing, severe||
9029|120|O|drowsiness, loss of consciousness.||
9029|121|B|||
9029|122|N|NOTES:  Do not share this medication with others.||
9029|123|N|   Lab and/or medical tests (such as complete blood count,||
9029|124|N|kidney/liver function) should be done while you are taking this||
9029|125|N|medication. Keep all medical and lab appointments. Consult your||
9029|126|N|doctor for more details.||
9029|127|B|||
9029|128|D|MISSED DOSE:  It is important to take each dose at the scheduled||
9029|129|D|time. If you miss a dose, take it as soon as you remember. If it||
9029|130|D|is near the time of the next dose, skip the missed dose. Take||
9029|131|D|your next dose at the regular time. Do not double the dose to||
9029|132|D|catch up.||
9029|133|B|||
9029|134|R|STORAGE:  Store at room temperature away from light and moisture.||
9029|135|R|Do not store in the bathroom. Protect from heat sources such as a||
9029|136|R|closed car or steam pipes. Do not use capsules that appear only||
9029|137|R|partly full or in which the contents have melted. Keep all||
9029|138|R|medications away from children and pets.||
9029|139|R|   Do not flush medications down the toilet or pour them into a||
9029|140|R|drain unless instructed to do so. Properly discard this product||
9029|141|R|when it is expired or no longer needed. Consult your pharmacist||
9029|142|R|or local waste disposal company.||
9029|143|B|||
9029|144|M|MEDICAL ALERT:  Your condition can cause complications in a||
9029|145|M|medical emergency. For information about enrolling in MedicAlert,||
9029|146|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9029|147|B|||
9029|148|A|Information last revised May 2025.||
9029|149|A|Copyright(c) 2025 First Databank, Inc.||
9029|150|B|||
9030|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9030|002|Z|does NOT have all possible information about this product. This||
9030|003|Z|information does not assure that this product is safe, effective,||
9030|004|Z|or appropriate for you. This information is not individual||
9030|005|Z|medical advice and does not substitute for the advice of your||
9030|006|Z|health care professional. Always ask your health care||
9030|007|Z|professional for complete information about this product and your||
9030|008|Z|specific health needs.||
9030|009|B|||
9030|010|T|APRACLONIDINE SOLUTION 1% - OPHTHALMIC||
9030|011|F|(A-pra-KLON-i-deen)||
9030|012|B|||
9030|013|C|COMMON BRAND NAME(S): Iopidine||
9030|014|B|||
9030|015|U|USES:  This medication is used to treat or prevent high pressure||
9030|016|U|inside the eye that may occur during and after laser eye surgery.||
9030|017|U|Decreasing high pressure inside the eye may help to prevent||
9030|018|U|decreased vision or blindness in the eye treated by laser||
9030|019|U|surgery. Apraclonidine is thought to work by decreasing the||
9030|020|U|amount of fluid within the eye.||
9030|021|B|||
9030|022|H|HOW TO USE:  This medication is given as an eye drop, usually by||
9030|023|H|a health care professional. It should not be taken by mouth or||
9030|024|H|injected into the eye. For laser eye surgery, it is usually given||
9030|025|H|1 hour before laser treatment and repeated at the end of||
9030|026|H|treatment.||
9030|027|H|   To apply eye drops, wash your hands first. To avoid||
9030|028|H|contamination, be careful not to touch the dropper tip or let it||
9030|029|H|touch your eye or any other surface.||
9030|030|H|   Tilt your head back, look up, and pull down the lower eyelid||
9030|031|H|to make a pouch. Hold the dropper directly over your eye and||
9030|032|H|place 1 drop into the pouch. Release the eyelid and gently close||
9030|033|H|your eyes. Place one finger at the corner of your eye (near the||
9030|034|H|nose) and apply gentle pressure for 1 to 2 minutes. This will||
9030|035|H|prevent the medication from draining out. Try not to blink and do||
9030|036|H|not rub your eye.||
9030|037|H|   Remove extra solution around the eye with a tissue and wash||
9030|038|H|your hands to remove any medicine that may be on them.||
9030|039|H|   If you are using another kind of eye medication (such as drops||
9030|040|H|or ointments), wait at least 5 minutes before using the other||
9030|041|H|medication. Use eye drops before ointments to allow the eye drops||
9030|042|H|to enter the eye.||
9030|043|B|||
9030|044|S|SIDE EFFECTS:  Eye discomfort/redness/burning, blurred vision,||
9030|045|S|upset stomach, dizziness, or drowsiness may occur. Eye||
9030|046|S|itching/watering or eyelid swelling may be symptoms of an||
9030|047|S|allergic reaction of the eye. If any of these effects last or get||
9030|048|S|worse, tell your doctor or pharmacist promptly.||
9030|049|S|   Remember that this medication has been prescribed because your||
9030|050|S|doctor has judged that the benefit to you is greater than the||
9030|051|S|risk of side effects. Many people using this medication do not||
9030|052|S|have serious side effects.||
9030|053|S|   Tell your doctor right away if you have any serious side||
9030|054|S|effects, including: fainting, mental/mood changes (such as||
9030|055|S|depression), slow/irregular heartbeat.||
9030|056|S|   A very serious allergic reaction to this drug is rare.||
9030|057|S|However, get medical help right away if you notice any symptoms||
9030|058|S|of a serious allergic reaction, including: rash, itching/swelling||
9030|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9030|060|S|breathing.||
9030|061|S|   This is not a complete list of possible side effects. If you||
9030|062|S|notice other effects not listed above, contact your doctor or||
9030|063|S|pharmacist.||
9030|064|S|   In the US -||
9030|065|S|   Call your doctor for medical advice about side effects. You||
9030|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9030|067|S|www.fda.gov/medwatch.||
9030|068|S|   In Canada - Call your doctor for medical advice about side||
9030|069|S|effects. You may report side effects to Health Canada at||
9030|070|S|1-866-234-2345.||
9030|071|B|||
9030|072|P|PRECAUTIONS:  Before using apraclonidine, tell your doctor or||
9030|073|P|pharmacist if you are allergic to it; or to clonidine; or if you||
9030|074|P|have any other allergies. This product may contain inactive||
9030|075|P|ingredients, which can cause allergic reactions or other||
9030|076|P|problems. Talk to your pharmacist for more details.||
9030|077|P|   Before using this medication, tell your doctor or pharmacist||
9030|078|P|your medical history, especially of: blood vessel disease (such||
9030|079|P|as cerebrovascular disease, Raynaud's disease), high blood||
9030|080|P|pressure, heart problems (such as recent heart attack), kidney||
9030|081|P|disease, mental/mood disorders (such as depression), fainting||
9030|082|P|after emotional stress (vasovagal attack).||
9030|083|P|   After you apply this drug, your vision may become temporarily||
9030|084|P|blurred or unstable. This drug may also rarely make you dizzy or||
9030|085|P|drowsy. Alcohol or marijuana (cannabis) can make you more dizzy||
9030|086|P|or drowsy. Do not drive, use machinery, or do anything that needs||
9030|087|P|alertness or clear vision until you can do it safely. Limit||
9030|088|P|alcoholic beverages. Talk to your doctor if you are using||
9030|089|P|marijuana (cannabis).||
9030|090|P|   During pregnancy, this medication should be used only when||
9030|091|P|clearly needed. Discuss the risks and benefits with your doctor.||
9030|092|P|   It is unknown if this medication passes into breast milk.||
9030|093|P|Consult your doctor before breastfeeding.||
9030|094|B|||
9030|095|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9030|096|I|medications work or increase your risk for serious side effects.||
9030|097|I|This document does not contain all possible drug interactions.||
9030|098|I|Keep a list of all the products you use (including||
9030|099|I|prescription/nonprescription drugs and herbal products) and share||
9030|100|I|it with your doctor and pharmacist. Do not start, stop, or change||
9030|101|I|the dosage of any medicines without your doctor's approval.||
9030|102|I|   Taking MAO inhibitors with this medication may cause a serious||
9030|103|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9030|104|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9030|105|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9030|106|I|selegiline, tranylcypromine) during treatment with this||
9030|107|I|medication. Most MAO inhibitors should also not be taken for two||
9030|108|I|weeks before treatment with this medication. Ask your doctor when||
9030|109|I|to start or stop taking this medication.||
9030|110|I|   Tell your doctor or pharmacist if you are taking other||
9030|111|I|products that cause drowsiness including alcohol, marijuana||
9030|112|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
9030|113|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
9030|114|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
9030|115|I|codeine).||
9030|116|I|   Check the labels on all your medicines (such as cough-and-cold||
9030|117|I|products) because they may contain ingredients that may cause||
9030|118|I|drowsiness. Ask your pharmacist about using those products||
9030|119|I|safely.||
9030|120|B|||
9030|121|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9030|122|O|has overdosed and has serious symptoms such as passing out or||
9030|123|O|trouble breathing, call 911. Otherwise, call a poison control||
9030|124|O|center right away. US residents can call 1-800-222-1222. Canada||
9030|125|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9030|126|O|include: slow heartbeat, drowsiness, cold/clammy skin.||
9030|127|B|||
9030|128|N|NOTES:  Do not share this medication with others.||
9030|129|N|   Lab and/or medical tests (such as pulse, blood pressure, eye||
9030|130|N|exams) may be done while you are using this medication. Keep all||
9030|131|N|medical and lab appointments. Consult your doctor for more||
9030|132|N|details.||
9030|133|B|||
9030|134|D|MISSED DOSE:  Not applicable.||
9030|135|B|||
9030|136|R|STORAGE:  Store in the refrigerator or at room temperature away||
9030|137|R|from light. Do not freeze. Keep all medications away from||
9030|138|R|children and pets.||
9030|139|R|   Do not flush medications down the toilet or pour them into a||
9030|140|R|drain unless instructed to do so. Properly discard this product||
9030|141|R|when it is expired or no longer needed. Consult your pharmacist||
9030|142|R|or local waste disposal company.||
9030|143|B|||
9030|144|A|Information last revised May 2024.||
9030|145|A|Copyright(c) 2025 First Databank, Inc.||
9030|146|B|||
9033|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9033|002|Z|does NOT have all possible information about this product. This||
9033|003|Z|information does not assure that this product is safe, effective,||
9033|004|Z|or appropriate for you. This information is not individual||
9033|005|Z|medical advice and does not substitute for the advice of your||
9033|006|Z|health care professional. Always ask your health care||
9033|007|Z|professional for complete information about this product and your||
9033|008|Z|specific health needs.||
9033|009|B|||
9033|010|T|CIMETIDINE - ORAL||
9033|011|F|(sye-MET-uh-deen)||
9033|012|B|||
9033|013|C|COMMON BRAND NAME(S): Tagamet||
9033|014|B|||
9033|015|U|USES:  Cimetidine is used to treat ulcers of the stomach and||
9033|016|U|intestines and prevent them from coming back after they have||
9033|017|U|healed. This medication is also used to treat certain stomach and||
9033|018|U|throat (esophagus) problems caused by too much stomach acid (such||
9033|019|U|as Zollinger-Ellison syndrome, erosive esophagitis) or a backward||
9033|020|U|flow of stomach acid into the esophagus (acid reflux||
9033|021|U|disease/GERD). Decreasing extra stomach acid can help relieve||
9033|022|U|symptoms such as stomach pain, heartburn, difficulty swallowing,||
9033|023|U|cough, and trouble sleeping. It can also prevent serious acid||
9033|024|U|damage to your digestive system (such as ulcers, cancer of the||
9033|025|U|esophagus).||
9033|026|U|   Cimetidine belongs to a class of drugs commonly called H2||
9033|027|U|blockers. It works by reducing the amount of acid in your||
9033|028|U|stomach.||
9033|029|U|   This medication is also available without a prescription. It||
9033|030|U|is used to treat occasional heartburn caused by too much acid in||
9033|031|U|the stomach (also called acid indigestion or sour stomach). It is||
9033|032|U|also used to prevent heartburn and acid indigestion caused by||
9033|033|U|certain foods and beverages. If you are taking this medication||
9033|034|U|for self-treatment, it is important to read the manufacturer's||
9033|035|U|package instructions carefully so you know when to consult your||
9033|036|U|doctor or pharmacist. (See also Precautions.)||
9033|037|U|   Do not use this medication to treat children younger than 12||
9033|038|U|unless directed by the doctor.||
9033|039|B|||
9033|040|H|HOW TO USE:  Take this medication by mouth with or without food||
9033|041|H|as directed by your doctor.||
9033|042|H|   If you are using the liquid form of this medication, carefully||
9033|043|H|measure the dose using a special measuring device/spoon. Do not||
9033|044|H|use a household spoon because you may not get the correct dose.||
9033|045|H|   The dosage and length of treatment are based on your medical||
9033|046|H|condition and response to treatment. Follow your doctor's||
9033|047|H|instructions carefully. If you are also taking antacids to||
9033|048|H|relieve stomach pain as recommended by your doctor, separate them||
9033|049|H|from this medication by at least 1 hour.||
9033|050|H|   Take this medication regularly as prescribed in order to get||
9033|051|H|the most benefit from it. To help you remember, take it at the||
9033|052|H|same time(s) each day. Do not increase your dose or take it more||
9033|053|H|often than directed. Continue to take this medication for the||
9033|054|H|prescribed length of treatment even if you are feeling better.||
9033|055|H|Stopping treatment too early may delay the healing process.||
9033|056|H|   If you are using nonprescription cimetidine for self-treatment||
9033|057|H|of acid indigestion or heartburn, take 1 tablet by mouth with a||
9033|058|H|glass of water as needed. To prevent heartburn, take 1 tablet by||
9033|059|H|mouth with a glass of water right before or up to 30 minutes||
9033|060|H|before eating food or drinking beverages that cause heartburn. Do||
9033|061|H|not take more than 2 tablets in 24 hours unless directed by your||
9033|062|H|doctor. Do not take for more than 14 days in a row without||
9033|063|H|talking with your doctor.||
9033|064|H|   Tell your doctor if your symptoms do not get better or if they||
9033|065|H|get worse.||
9033|066|B|||
9033|067|S|SIDE EFFECTS:  Headache, dizziness, drowsiness, or diarrhea may||
9033|068|S|occur. If any of these effects last or get worse, tell your||
9033|069|S|doctor or pharmacist promptly.||
9033|070|S|   If your doctor has directed you to use this medication,||
9033|071|S|remember that your doctor has judged that the benefit to you is||
9033|072|S|greater than the risk of side effects. Many people using this||
9033|073|S|medication do not have serious side effects.||
9033|074|S|   Tell your doctor right away if you have any serious side||
9033|075|S|effects, including: mental/mood changes (such as agitation,||
9033|076|S|confusion, depression, hallucinations), trouble urinating,||
9033|077|S|muscle/joint pain, breast swelling/soreness in males, decreased||
9033|078|S|sexual ability (with very high doses of this medication), easy||
9033|079|S|bruising/bleeding, signs of infection (such as sore throat that||
9033|080|S|doesn't go away, fever, chills), fast/slow/irregular heartbeat,||
9033|081|S|unusual tiredness, signs of liver problems (such as||
9033|082|S|nausea/vomiting that doesn't stop, stomach/abdominal pain, dark||
9033|083|S|urine, yellowing eyes/skin), signs of kidney problems (such as||
9033|084|S|change in the amount of urine).||
9033|085|S|   A very serious allergic reaction to this drug is rare.||
9033|086|S|However, get medical help right away if you notice any symptoms||
9033|087|S|of a serious allergic reaction, including: rash, itching/swelling||
9033|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9033|089|S|breathing.||
9033|090|S|   This is not a complete list of possible side effects. If you||
9033|091|S|notice other effects not listed above, contact your doctor or||
9033|092|S|pharmacist.||
9033|093|S|   In the US -||
9033|094|S|   Call your doctor for medical advice about side effects. You||
9033|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9033|096|S|www.fda.gov/medwatch.||
9033|097|S|   In Canada - Call your doctor for medical advice about side||
9033|098|S|effects. You may report side effects to Health Canada at||
9033|099|S|1-866-234-2345.||
9033|100|B|||
9033|101|P|PRECAUTIONS:  Before taking cimetidine, tell your doctor or||
9033|102|P|pharmacist if you are allergic to it; or to other H2 blockers||
9033|103|P|(such as famotidine, nizatidine, ranitidine); or if you have any||
9033|104|P|other allergies. This product may contain inactive ingredients,||
9033|105|P|which can cause allergic reactions or other problems. Talk to||
9033|106|P|your pharmacist for more details.||
9033|107|P|   Before using this medication, tell your doctor or pharmacist||
9033|108|P|your medical history, especially of: immune system problems,||
9033|109|P|kidney problems, liver problems, certain lung diseases (chronic||
9033|110|P|obstructive pulmonary disease-COPD), diabetes, other stomach||
9033|111|P|problems (such as tumors).||
9033|112|P|   Some symptoms may actually be signs of a more serious||
9033|113|P|condition. Get medical help right away if you have: heartburn||
9033|114|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
9033|115|P|pain (especially with shortness of breath, unusual sweating),||
9033|116|P|unexplained weight loss.||
9033|117|P|   In addition, before you self-treat with this medication, get||
9033|118|P|medical help right away if you have any of these signs of a||
9033|119|P|serious condition: trouble/pain swallowing food, bloody vomit,||
9033|120|P|vomit that looks like coffee grounds, bloody/black stools,||
9033|121|P|heartburn for over 3 months, frequent chest pain, frequent||
9033|122|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
9033|123|P|pain.||
9033|124|P|   Liquid products may contain sugar and/or alcohol. Caution is||
9033|125|P|advised if you have diabetes, liver disease, or any other||
9033|126|P|condition that requires you to limit/avoid these substances in||
9033|127|P|your diet. Ask your doctor or pharmacist about using this product||
9033|128|P|safely.||
9033|129|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9033|130|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9033|131|P|machinery, or do anything that needs alertness until you can do||
9033|132|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9033|133|P|are using marijuana (cannabis).||
9033|134|P|   Before having surgery, tell your doctor or dentist about all||
9033|135|P|the products you use (including prescription drugs,||
9033|136|P|nonprescription drugs, and herbal products).||
9033|137|P|   Older adults may be more sensitive to the side effects of this||
9033|138|P|drug, especially confusion and lung infection (pneumonia).||
9033|139|P|Confusion can increase the risk of falling.||
9033|140|P|   During pregnancy, cimetidine should be used only when clearly||
9033|141|P|needed. Discuss the risks and benefits with your doctor.||
9033|142|P|   Cimetidine passes into breast milk. Consult your doctor before||
9033|143|P|breastfeeding.||
9033|144|B|||
9033|145|I|DRUG INTERACTIONS:  See also How to Use section.||
9033|146|I|   Drug interactions may change how your medications work or||
9033|147|I|increase your risk for serious side effects. This document does||
9033|148|I|not contain all possible drug interactions. Keep a list of all||
9033|149|I|the products you use (including prescription/nonprescription||
9033|150|I|drugs and herbal products) and share it with your doctor and||
9033|151|I|pharmacist. Do not start, stop, or change the dosage of any||
9033|152|I|medicines without your doctor's approval.||
9033|153|I|   Some products that may interact with this drug include:||
9033|154|I|dofetilide, epirubicin, artemether, clopidogrel, lumefantrine,||
9033|155|I|metformin, moclobemide, moricizine, quinidine, silver||
9033|156|I|sulfadiazine.||
9033|157|I|   This medication can slow down the removal of other medications||
9033|158|I|from your body, which may affect how they work. Examples of||
9033|159|I|affected drugs include fezolinetant, metoprolol, tacrine,||
9033|160|I|warfarin, zaleplon, calcium channel blockers (such as diltiazem),||
9033|161|I|tricyclic antidepressants (such as amitriptyline), theophylline,||
9033|162|I|among others.||
9033|163|I|   Since cimetidine reduces the amount of acid in your stomach,||
9033|164|I|it may also change the absorption of certain medications and||
9033|165|I|affect how they work. Some examples of affected drugs include||
9033|166|I|atazanavir, dasatinib, certain azole antifungals (such as||
9033|167|I|itraconazole, ketoconazole), levoketoconazole, pazopanib,||
9033|168|I|sparsentan, among others. Ask your doctor or pharmacist if any of||
9033|169|I|the medications you take are affected by cimetidine and how to||
9033|170|I|manage this interaction.||
9033|171|I|   Cigarette smoking can affect this medication. Tell your doctor||
9033|172|I|if you smoke and if you stop or start smoking while using this||
9033|173|I|medication.||
9033|174|I|   This medication and similar H2 blockers (such as famotidine,||
9033|175|I|nizatidine, ranitidine) are available both with and without a||
9033|176|I|prescription. Do not take them at the same time.||
9033|177|B|||
9033|178|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9033|179|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9033|180|O|poison control center right away. US residents can call||
9033|181|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9033|182|O|Symptoms of overdose may include mental/mood changes, trouble||
9033|183|O|speaking, difficulty awakening.||
9033|184|B|||
9033|185|N|NOTES:  Do not share this medication with others.||
9033|186|N|   Lifestyle changes such as stress reduction programs, stopping||
9033|187|N|smoking, limiting alcohol, and diet changes (such as avoiding||
9033|188|N|caffeine and spicy foods) may increase the effectiveness of this||
9033|189|N|medication. Talk to your doctor or pharmacist about lifestyle||
9033|190|N|changes that might benefit you.||
9033|191|N|   Lab and/or medical tests may be done while you are taking this||
9033|192|N|medication. Keep all medical and lab appointments. Consult your||
9033|193|N|doctor for more details.||
9033|194|B|||
9033|195|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9033|196|D|remember. If it is near the time of the next dose, skip the||
9033|197|D|missed dose. Take your next dose at the regular time. Do not||
9033|198|D|double the dose to catch up.||
9033|199|B|||
9033|200|R|STORAGE:  Store at room temperature away from light and moisture.||
9033|201|R|Do not store in the bathroom. Keep all medications away from||
9033|202|R|children and pets.||
9033|203|R|   Do not flush medications down the toilet or pour them into a||
9033|204|R|drain unless instructed to do so. Properly discard this product||
9033|205|R|when it is expired or no longer needed. Consult your pharmacist||
9033|206|R|or local waste disposal company.||
9033|207|B|||
9033|208|A|Information last revised May 2025.||
9033|209|A|Copyright(c) 2025 First Databank, Inc.||
9033|210|B|||
9034|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9034|002|Z|does NOT have all possible information about this product. This||
9034|003|Z|information does not assure that this product is safe, effective,||
9034|004|Z|or appropriate for you. This information is not individual||
9034|005|Z|medical advice and does not substitute for the advice of your||
9034|006|Z|health care professional. Always ask your health care||
9034|007|Z|professional for complete information about this product and your||
9034|008|Z|specific health needs.||
9034|009|B|||
9034|010|T|THIOTHIXENE - ORAL||
9034|011|F|(thigh-oh-THICKS-een)||
9034|012|B|||
9034|013|C|COMMON BRAND NAME(S): Navane||
9034|014|B|||
9034|015|W|WARNING:  There may be a slightly increased risk of serious,||
9034|016|W|possibly fatal side effects (such as heart failure,||
9034|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
9034|018|W|by older adults with dementia. This medication is not approved||
9034|019|W|for the treatment of dementia-related behavior problems. Discuss||
9034|020|W|the risks and benefits of this medication, as well as other||
9034|021|W|effective and possibly safer treatments for dementia-related||
9034|022|W|behavior problems, with the doctor.||
9034|023|B|||
9034|024|U|USES:  This medication is used to treat certain mental/mood||
9034|025|U|disorders (such as schizophrenia). Thiothixene belongs to a class||
9034|026|U|of drugs known as antipsychotics. It works by helping to restore||
9034|027|U|the balance of certain natural substances in the brain.||
9034|028|B|||
9034|029|H|HOW TO USE:  Take this medication by mouth with or without food||
9034|030|H|as directed by your doctor, usually 1 to 3 times daily.||
9034|031|H|   The dosage is based on your age, medical condition, and||
9034|032|H|response to treatment. To reduce your risk of side effects such||
9034|033|H|as drowsiness and shaking (tremor), your doctor may direct you to||
9034|034|H|start this medication at a low dose and gradually increase your||
9034|035|H|dose. Follow your doctor's directions carefully.||
9034|036|H|   Take this medication regularly in order to get the most||
9034|037|H|benefit from it. To help you remember, take it at the same||
9034|038|H|time(s) each day.||
9034|039|H|   Although you may notice some medication effects soon after||
9034|040|H|starting, for some conditions it may take 2 to 3 weeks before you||
9034|041|H|get the full benefit of this drug.||
9034|042|H|   Do not stop taking this medication without consulting your||
9034|043|H|doctor. Some conditions may become worse when this drug is||
9034|044|H|suddenly stopped. Also, you may experience symptoms such as||
9034|045|H|severe confusion and hallucinations. To prevent these symptoms||
9034|046|H|while you are stopping treatment with this drug, your doctor may||
9034|047|H|reduce your dose gradually. Consult your doctor or pharmacist for||
9034|048|H|more details. Report any new or worsening symptoms right away.||
9034|049|H|   Tell your doctor if your condition does not get better or if||
9034|050|H|it gets worse.||
9034|051|B|||
9034|052|S|SIDE EFFECTS:  See also Warning section.||
9034|053|S|   Drowsiness, dizziness, lightheadedness, dry mouth, blurred||
9034|054|S|vision, constipation, and trouble sleeping may occur. If any of||
9034|055|S|these effects last or get worse, tell your doctor or pharmacist||
9034|056|S|promptly.||
9034|057|S|   Dizziness and lightheadedness can increase the risk of||
9034|058|S|falling. Get up slowly when rising from a sitting or lying||
9034|059|S|position.||
9034|060|S|   Tell your doctor right away if any of these side effects||
9034|061|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
9034|062|S|mask-like expression of the face, drooling/trouble swallowing, or||
9034|063|S|shuffling walk. Your doctor may prescribe another medication to||
9034|064|S|decrease these side effects.||
9034|065|S|   Remember that this medication has been prescribed because your||
9034|066|S|doctor has judged that the benefit to you is greater than the||
9034|067|S|risk of side effects. Many people using this medication do not||
9034|068|S|have serious side effects.||
9034|069|S|   Tell your doctor right away if you have any serious side||
9034|070|S|effects, including: fainting, confusion, depression/suicidal||
9034|071|S|thoughts, difficulty urinating, easy bruising/bleeding, signs of||
9034|072|S|infection (such as sore throat that doesn't go away, fever,||
9034|073|S|chills), severe stomach/abdominal pain, seizures.||
9034|074|S|   This medication may cause a condition known as tardive||
9034|075|S|dyskinesia. In some cases, this condition may be permanent. Tell||
9034|076|S|your doctor right away if you develop any involuntary/repetitive||
9034|077|S|muscle movements such as lip smacking/puckering, tongue||
9034|078|S|thrusting, chewing, or finger/toe movements.||
9034|079|S|   In rare cases, thiothixene may increase your level of a||
9034|080|S|certain chemical made by the body (prolactin). For females, this||
9034|081|S|increase in prolactin may result in unwanted breast milk,||
9034|082|S|missed/stopped periods, or difficulty becoming pregnant. For||
9034|083|S|males, it may result in decreased sexual ability, inability to||
9034|084|S|produce sperm, or enlarged breasts. If you develop any of these||
9034|085|S|symptoms, tell your doctor right away.||
9034|086|S|   This medication may rarely cause a very serious condition||
9034|087|S|called neuroleptic malignant syndrome (NMS). Get medical help||
9034|088|S|right away if you have any of the following symptoms: fever,||
9034|089|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
9034|090|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
9034|091|S|signs of kidney problems (such as change in the amount of urine).||
9034|092|S|   A very serious allergic reaction to this drug is rare.||
9034|093|S|However, get medical help right away if you notice any symptoms||
9034|094|S|of a serious allergic reaction, including: rash, itching/swelling||
9034|095|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9034|096|S|breathing.||
9034|097|S|   This is not a complete list of possible side effects. If you||
9034|098|S|notice other effects not listed above, contact your doctor or||
9034|099|S|pharmacist.||
9034|100|S|   In the US -||
9034|101|S|   Call your doctor for medical advice about side effects. You||
9034|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9034|103|S|www.fda.gov/medwatch.||
9034|104|S|   In Canada - Call your doctor for medical advice about side||
9034|105|S|effects. You may report side effects to Health Canada at||
9034|106|S|1-866-234-2345.||
9034|107|B|||
9034|108|P|PRECAUTIONS:  See also Warning section.||
9034|109|P|   Before taking this medication, tell your doctor or pharmacist||
9034|110|P|if you are allergic to it; or if you have any other allergies.||
9034|111|P|This product may contain inactive ingredients, which can cause||
9034|112|P|allergic reactions or other problems. Talk to your pharmacist for||
9034|113|P|more details.||
9034|114|P|   Before using this medication, tell your doctor or pharmacist||
9034|115|P|your medical history, especially of: blood problems (such as low||
9034|116|P|red/white/platelet blood cell counts), a certain eye condition||
9034|117|P|(glaucoma), heart problems (such as fast/irregular heartbeat, low||
9034|118|P|blood pressure), liver disease, breast cancer, brain||
9034|119|P|disorder/tumor/injury, drug/alcohol/substance abuse, Parkinson's||
9034|120|P|disease, seizures, a certain severe reaction to other||
9034|121|P|antipsychotic-type medications (neuroleptic malignant||
9034|122|P|syndrome-NMS), slow movement of the gut/intestines (such as||
9034|123|P|chronic constipation, intestinal blockage), difficulty urinating||
9034|124|P|(such as due to prostate problems).||
9034|125|P|   This drug may make you dizzy or drowsy or blur your vision.||
9034|126|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9034|127|P|drowsy. Do not drive, use machinery, or do anything that needs||
9034|128|P|alertness or clear vision until you can do it safely. Avoid||
9034|129|P|alcoholic beverages. Talk to your doctor if you are using||
9034|130|P|marijuana (cannabis).||
9034|131|P|   This medication may make you more sensitive to the sun. Limit||
9034|132|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9034|133|P|sunscreen and wear protective clothing when outdoors. Tell your||
9034|134|P|doctor right away if you get sunburned or have skin||
9034|135|P|blisters/redness.||
9034|136|P|   Before having surgery or imaging procedures (such as certain||
9034|137|P|X-rays, CT scans) requiring the use of contrast dye (such as||
9034|138|P|metrizamide), tell your doctor or dentist that you are using this||
9034|139|P|medication and about all the products you use (including||
9034|140|P|prescription drugs, nonprescription drugs, and herbal products).||
9034|141|P|   This medication may make you sweat less, making you more||
9034|142|P|likely to get heat stroke. Avoid doing things that may cause you||
9034|143|P|to overheat, such as hard work or exercise in hot weather, or||
9034|144|P|using hot tubs. When the weather is hot, drink a lot of fluids||
9034|145|P|and dress lightly. If you overheat, quickly look for a place to||
9034|146|P|cool down and rest. Get medical help right away if you have a||
9034|147|P|fever that does not go away, mental/mood changes, headache, or||
9034|148|P|dizziness.||
9034|149|P|   Older adults may be more sensitive to the side effects of this||
9034|150|P|drug, especially dizziness, lightheadedness, drowsiness,||
9034|151|P|confusion, constipation, trouble urinating, muscle||
9034|152|P|spasm/stiffness, and uncontrolled movements (tardive dyskinesia).||
9034|153|P|Dizziness, lightheadedness, drowsiness, and confusion can||
9034|154|P|increase the risk of falling.||
9034|155|P|   During pregnancy, this medication should be used only when||
9034|156|P|clearly needed. Babies born to mothers who have used this drug||
9034|157|P|during the last 3 months of pregnancy may rarely develop symptoms||
9034|158|P|including muscle stiffness or shakiness, drowsiness,||
9034|159|P|feeding/breathing difficulties, or constant crying. If you notice||
9034|160|P|any of these symptoms in your newborn especially during their||
9034|161|P|first month, tell the doctor right away.||
9034|162|P|   Since untreated mental/mood problems (such as schizophrenia)||
9034|163|P|can be a serious condition, do not stop taking this medication||
9034|164|P|unless directed by your doctor. If you are planning pregnancy,||
9034|165|P|become pregnant, or think you may be pregnant, immediately||
9034|166|P|discuss with your doctor the benefits and risks of using this||
9034|167|P|medication during pregnancy.||
9034|168|P|   It is unknown if this medication passes into breast milk.||
9034|169|P|Consult your doctor before breastfeeding.||
9034|170|B|||
9034|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9034|172|I|medications work or increase your risk for serious side effects.||
9034|173|I|This document does not contain all possible drug interactions.||
9034|174|I|Keep a list of all the products you use (including||
9034|175|I|prescription/nonprescription drugs and herbal products) and share||
9034|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
9034|177|I|the dosage of any medicines without your doctor's approval.||
9034|178|I|   Some products that may interact with this drug include:||
9034|179|I|lithium, drugs that lower blood pressure (such as guanethidine,||
9034|180|I|alpha blockers like prazosin).||
9034|181|I|   Tell your doctor or pharmacist if you are taking other||
9034|182|I|products that cause drowsiness including alcohol, marijuana||
9034|183|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
9034|184|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
9034|185|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
9034|186|I|codeine).||
9034|187|I|   Check the labels on all your medicines (such as allergy or||
9034|188|I|cough-and-cold products) because they may contain ingredients||
9034|189|I|that cause drowsiness. Ask your pharmacist about using those||
9034|190|I|products safely.||
9034|191|B|||
9034|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9034|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9034|194|O|poison control center right away. US residents can call||
9034|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9034|196|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
9034|197|O|inability to wake up (coma).||
9034|198|B|||
9034|199|N|NOTES:  Do not share this medication with others.||
9034|200|N|   Lab and/or medical tests (such as complete blood count, eye||
9034|201|N|exams) should be done while you are taking this medication. Keep||
9034|202|N|all medical and lab appointments. Consult your doctor for more||
9034|203|N|details.||
9034|204|B|||
9034|205|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9034|206|D|remember. If it is near the time of the next dose, skip the||
9034|207|D|missed dose. Take your next dose at the regular time. Do not||
9034|208|D|double the dose to catch up.||
9034|209|B|||
9034|210|R|STORAGE:  Store at room temperature away from light and moisture.||
9034|211|R|Do not store in the bathroom. Keep all medications away from||
9034|212|R|children and pets.||
9034|213|R|   Do not flush medications down the toilet or pour them into a||
9034|214|R|drain unless instructed to do so. Properly discard this product||
9034|215|R|when it is expired or no longer needed. Consult your pharmacist||
9034|216|R|or local waste disposal company.||
9034|217|B|||
9034|218|A|Information last revised May 2025.||
9034|219|A|Copyright(c) 2025 First Databank, Inc.||
9034|220|B|||
9037|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9037|002|Z|does NOT have all possible information about this product. This||
9037|003|Z|information does not assure that this product is safe, effective,||
9037|004|Z|or appropriate for you. This information is not individual||
9037|005|Z|medical advice and does not substitute for the advice of your||
9037|006|Z|health care professional. Always ask your health care||
9037|007|Z|professional for complete information about this product and your||
9037|008|Z|specific health needs.||
9037|009|B|||
9037|010|T|INSULIN LISPRO - INJECTION||
9037|011|F|(IN-su-lin LIS-proe)||
9037|012|B|||
9037|013|C|COMMON BRAND NAME(S): Humalog||
9037|014|B|||
9037|015|U|USES:  Insulin lispro is used with a proper diet and exercise||
9037|016|U|program to control high blood sugar in people with diabetes.||
9037|017|U|Controlling high blood sugar helps prevent kidney damage,||
9037|018|U|blindness, nerve problems, loss of limbs, and sexual function||
9037|019|U|problems. Proper control of diabetes may also lessen your risk of||
9037|020|U|a heart attack or stroke.||
9037|021|U|   Insulin lispro is a man-made product that is similar to human||
9037|022|U|insulin. It replaces the insulin that your body would normally||
9037|023|U|make. Insulin lispro starts working faster and lasts for a||
9037|024|U|shorter time than regular insulin. It works by helping blood||
9037|025|U|sugar (glucose) get into cells so your body can use it for||
9037|026|U|energy. This medication is usually used with a medium- or||
9037|027|U|long-acting insulin product. Insulin lispro may also be used with||
9037|028|U|other oral diabetes medications (such as sulfonylureas like||
9037|029|U|glyburide or glipizide).||
9037|030|B|||
9037|031|H|HOW TO USE:  Read the Patient Information Leaflet and||
9037|032|H|Instructions for Use if available from your pharmacist before you||
9037|033|H|start using this medication and each time you get a refill. Ask||
9037|034|H|your health care professional how to prepare and use this||
9037|035|H|medication. If you have any questions, ask your doctor or||
9037|036|H|pharmacist.||
9037|037|H|   Inject this medication under the skin as directed by your||
9037|038|H|doctor, usually within 15 minutes before eating a meal or||
9037|039|H|immediately after a meal. Because this insulin is fast-acting,||
9037|040|H|not eating right after a dose of insulin may lead to low blood||
9037|041|H|sugar (hypoglycemia). Do not inject if you have low blood sugar.||
9037|042|H|The injection is given in the stomach area, the thigh, the||
9037|043|H|buttocks, or the back of the upper arm. Do not inject into a vein||
9037|044|H|or muscle because very low blood sugar may occur.||
9037|045|H|   The dosage is based on your medical condition and response to||
9037|046|H|treatment. Measure each dose very carefully because even small||
9037|047|H|changes in the amount of insulin may have a large effect on your||
9037|048|H|blood sugar.||
9037|049|H|   Before using, check this product for particles or||
9037|050|H|discoloration. If either is present, do not use the insulin.||
9037|051|H|Before injecting each dose, clean the skin you are going to||
9037|052|H|inject into (the injection site) with rubbing alcohol. Change the||
9037|053|H|injection site each time to lessen injury under the skin (for||
9037|054|H|example, pits/lumps or thickened skin). Do not inject into skin||
9037|055|H|that is red, swollen, itchy, or damaged. To lessen bruising, do||
9037|056|H|not rub the injection site after a shot. Do not inject cold||
9037|057|H|insulin because this can be painful. The insulin container you||
9037|058|H|are currently using can be kept at room temperature. Learn how to||
9037|059|H|store and discard medical supplies safely.||
9037|060|H|   Giving insulin lispro into a vein should only be done by a||
9037|061|H|health care professional. Very low blood sugar may result.||
9037|062|H|   If you are directed to inject this insulin with an infusion||
9037|063|H|pump, read the instruction manual and directions that come with||
9037|064|H|the infusion pump. If you have any questions, ask your health||
9037|065|H|care professional. Avoid exposing the pump or its tubing to||
9037|066|H|direct sunlight or other heat sources. Do not dilute insulin if||
9037|067|H|you are using an insulin pump.||
9037|068|H|   This product may be mixed only with certain other insulin||
9037|069|H|products such as NPH insulin. Always draw the insulin lispro into||
9037|070|H|the syringe first, then follow with the longer-acting insulin.||
9037|071|H|Never inject a mixture of different insulins into a vein. Consult||
9037|072|H|your health care professional about which products may be mixed,||
9037|073|H|the proper method for mixing insulin, and the proper way to||
9037|074|H|inject mixtures of insulin. Do not mix insulins if you are using||
9037|075|H|an insulin pump.||
9037|076|H|   Do not change brands or types of insulin without directions on||
9037|077|H|how to do so from your doctor.||
9037|078|H|   Do not share your pen device with another person, even if the||
9037|079|H|needle is changed. You may give other people a serious infection,||
9037|080|H|or get a serious infection from them.||
9037|081|H|   Use this medication regularly to get the most benefit from it.||
9037|082|H|To help you remember, use it at the same times each day.||
9037|083|H|   Tell your doctor if your condition does not get better or if||
9037|084|H|it gets worse (your blood sugar is too high or too low).||
9037|085|B|||
9037|086|S|SIDE EFFECTS:  Injection site reactions (such as pain, redness,||
9037|087|S|irritation) and weight gain may occur. If any of these effects||
9037|088|S|last or get worse, tell your doctor or pharmacist promptly.||
9037|089|S|   Remember that this medication has been prescribed because your||
9037|090|S|doctor has judged that the benefit to you is greater than the||
9037|091|S|risk of side effects. Many people using this medication do not||
9037|092|S|have serious side effects.||
9037|093|S|   Tell your doctor right away if you have any serious side||
9037|094|S|effects, including: signs of low potassium level in the blood||
9037|095|S|(such as muscle cramps, weakness, irregular heartbeat).||
9037|096|S|   This medication can cause low blood sugar (hypoglycemia). This||
9037|097|S|may occur if you do not get enough calories from food or if you||
9037|098|S|do unusually heavy exercise. Symptoms of low blood sugar include||
9037|099|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
9037|100|S|dizziness, or tingling hands/feet. It is a good habit to carry||
9037|101|S|glucose tablets or gel to treat low blood sugar. If you don't||
9037|102|S|have these reliable forms of glucose, rapidly raise your blood||
9037|103|S|sugar by eating a quick source of sugar such as table sugar,||
9037|104|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
9037|105|S|doctor right away about the reaction and the use of this product.||
9037|106|S|To help prevent low blood sugar, eat meals on a regular schedule,||
9037|107|S|and do not skip meals. Check with your doctor or pharmacist to||
9037|108|S|find out what you should do if you miss a meal.||
9037|109|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
9037|110|S|thirst/urination. If these symptoms occur, tell your doctor right||
9037|111|S|away. Your doctor may need to adjust your diabetes medication,||
9037|112|S|exercise program, or diet.||
9037|113|S|   A very serious allergic reaction to this drug is rare.||
9037|114|S|However, get medical help right away if you notice any symptoms||
9037|115|S|of a serious allergic reaction, including: rash, itching/swelling||
9037|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9037|117|S|breathing.||
9037|118|S|   This is not a complete list of possible side effects. If you||
9037|119|S|notice other effects not listed above, contact your doctor or||
9037|120|S|pharmacist.||
9037|121|S|   In the US -||
9037|122|S|   Call your doctor for medical advice about side effects. You||
9037|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9037|124|S|www.fda.gov/medwatch.||
9037|125|S|   In Canada - Call your doctor for medical advice about side||
9037|126|S|effects. You may report side effects to Health Canada at||
9037|127|S|1-866-234-2345.||
9037|128|B|||
9037|129|P|PRECAUTIONS:  Before using insulin lispro, tell your doctor or||
9037|130|P|pharmacist if you are allergic to it; or to other insulins (such||
9037|131|P|as insulin lispro-aabc); or if you have any other allergies. This||
9037|132|P|product may contain inactive ingredients, which can cause||
9037|133|P|allergic reactions or other problems. Talk to your pharmacist for||
9037|134|P|more details.||
9037|135|P|   Do not use this medication when you have low blood sugar||
9037|136|P|(hypoglycemia).||
9037|137|P|   Before using this medication, tell your doctor or pharmacist||
9037|138|P|your medical history, especially of: kidney disease, liver||
9037|139|P|disease, thyroid problems.||
9037|140|P|   You may experience blurred vision, dizziness, or drowsiness||
9037|141|P|due to extremely low or high blood sugar. Do not drive, use||
9037|142|P|machinery, or do anything that needs alertness or clear vision||
9037|143|P|until you can do it safely.||
9037|144|P|   Limit alcohol while using this medication because it can||
9037|145|P|increase your risk of developing low blood sugar.||
9037|146|P|   It may be harder to control your blood sugar when your body is||
9037|147|P|stressed (such as due to fever, infection, injury, or surgery).||
9037|148|P|Consult your doctor because this may require a change in your||
9037|149|P|treatment plan, medications, or blood sugar testing.||
9037|150|P|   Before having surgery, tell your doctor or dentist about all||
9037|151|P|the products you use (including prescription drugs,||
9037|152|P|nonprescription drugs, and herbal products).||
9037|153|P|   Check your blood sugar before and after exercise. You may need||
9037|154|P|a snack beforehand.||
9037|155|P|   If traveling across time zones, ask your doctor about how to||
9037|156|P|adjust your insulin schedule. Take extra insulin and supplies||
9037|157|P|with you.||
9037|158|P|   Older adults may be more sensitive to the side effects of this||
9037|159|P|drug, especially low blood sugar.||
9037|160|P|   Children may be more sensitive to the side effects of this||
9037|161|P|drug, especially low blood sugar.||
9037|162|P|   Tell your doctor right away if you are pregnant. Pregnancy may||
9037|163|P|cause or worsen diabetes. Discuss a plan with your doctor for||
9037|164|P|managing your blood sugar while pregnant. Your doctor may change||
9037|165|P|your diabetes treatment during your pregnancy (such as diet and||
9037|166|P|medications including insulin).||
9037|167|P|   This medication passes into breast milk, but is unlikely to||
9037|168|P|harm a nursing infant. Consult your doctor before breastfeeding.||
9037|169|P|Your insulin needs may change while breastfeeding.||
9037|170|B|||
9037|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9037|172|I|medications work or increase your risk for serious side effects.||
9037|173|I|This document does not contain all possible drug interactions.||
9037|174|I|Keep a list of all the products you use (including||
9037|175|I|prescription/nonprescription drugs and herbal products) and share||
9037|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
9037|177|I|the dosage of any medicines without your doctor's approval.||
9037|178|I|   Beta-blocker medications (such as metoprolol, propranolol,||
9037|179|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
9037|180|I|heartbeat you would usually feel when your blood sugar falls too||
9037|181|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
9037|182|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
9037|183|I|   Many drugs can affect your blood sugar levels, making it more||
9037|184|I|difficult to control your blood sugar. Before you start, stop, or||
9037|185|I|change any medication, talk with your doctor or pharmacist about||
9037|186|I|how the medication may affect your blood sugar. Check your blood||
9037|187|I|sugar regularly as directed by your doctor. Tell your doctor||
9037|188|I|about the results and of any symptoms of high or low blood sugar.||
9037|189|I|(See also Side Effects section.) Your doctor may need to adjust||
9037|190|I|your diabetes medication, exercise program, or diet.||
9037|191|I|   Insulin lispro is very similar to insulin lispro-aabc. Do not||
9037|192|I|use insulin lispro-aabc while using insulin lispro.||
9037|193|B|||
9037|194|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9037|195|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9037|196|O|poison control center right away. US residents can call||
9037|197|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9037|198|O|Symptoms of overdose may include: signs of low blood sugar such||
9037|199|O|as sweating, shakiness, loss of consciousness, fast heartbeat.||
9037|200|B|||
9037|201|N|NOTES:  Do not share this medication, needles, or syringes with||
9037|202|N|others.||
9037|203|N|   Attend a diabetes education program to learn more about how to||
9037|204|N|manage your diabetes with medications, diet, exercise, and||
9037|205|N|regular medical exams.||
9037|206|N|   Learn the symptoms of high and low blood sugar and how to||
9037|207|N|treat low blood sugar. Check your blood sugar regularly as||
9037|208|N|directed and share the results with your doctor.||
9037|209|N|   Lab and/or medical tests (such as liver/kidney function,||
9037|210|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
9037|211|N|should be done while you are taking this medication. Keep all||
9037|212|N|medical and lab appointments.||
9037|213|N|   Keep extra supplies of insulin, syringes, and needles on hand.||
9037|214|B|||
9037|215|D|MISSED DOSE:  It is very important to follow your insulin regimen||
9037|216|D|exactly. Ask your doctor ahead of time what you should do if you||
9037|217|D|miss a dose of insulin.||
9037|218|B|||
9037|219|R|STORAGE:  Store all unopened insulin products in the||
9037|220|R|refrigerator. Opened insulin lispro vials may be stored in the||
9037|221|R|refrigerator or at room temperature. Opened insulin lispro||
9037|222|R|cartridges and prefilled pens can only be stored at room||
9037|223|R|temperature and should not be refrigerated. Throw away all||
9037|224|R|insulin lispro in use after 28 days, even if there is insulin||
9037|225|R|left. Also throw away all insulin products after the expiration||
9037|226|R|date on the package. Do not freeze and do not use insulin that||
9037|227|R|has been frozen.||
9037|228|R|   If using this drug in an insulin pump, do not store this drug||
9037|229|R|in the pump for more than 7 days. Doing so may lead to||
9037|230|R|ineffective treatment and high blood sugar. Do not expose the||
9037|231|R|insulin in your pump to direct sunlight or temperatures above||
9037|232|R|98.6 degrees F (37 degrees C).||
9037|233|R|   Protect insulin from light and heat. Do not store in the||
9037|234|R|bathroom. Keep all medications away from children and pets.||
9037|235|R|   Do not flush medications down the toilet or pour them into a||
9037|236|R|drain unless instructed to do so. Properly discard this product||
9037|237|R|when it is expired or no longer needed. Consult your pharmacist||
9037|238|R|or local waste disposal company.||
9037|239|B|||
9037|240|M|MEDICAL ALERT:  Your condition can cause complications in a||
9037|241|M|medical emergency. For information about enrolling in MedicAlert,||
9037|242|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9037|243|B|||
9037|244|A|Information last revised April 2025.||
9037|245|A|Copyright(c) 2025 First Databank, Inc.||
9037|246|B|||
9038|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9038|002|Z|does NOT have all possible information about this product. This||
9038|003|Z|information does not assure that this product is safe, effective,||
9038|004|Z|or appropriate for you. This information is not individual||
9038|005|Z|medical advice and does not substitute for the advice of your||
9038|006|Z|health care professional. Always ask your health care||
9038|007|Z|professional for complete information about this product and your||
9038|008|Z|specific health needs.||
9038|009|B|||
9038|010|T|MULTIVITAMINS (INCLUDES PRENATAL VITAMINS) - ORAL||
9038|011|B|||
9038|012|W|WARNING:  If your brand of multivitamin contains iron, it is||
9038|013|W|important to keep this product out of reach of children.||
9038|014|W|Accidental overdose of iron-containing products is a leading||
9038|015|W|cause of fatal poisoning in children younger than 6 years. If||
9038|016|W|overdose does occur, get medical help right away or call a poison||
9038|017|W|control center.||
9038|018|B|||
9038|019|U|USES:  This medication is a multivitamin product used to treat or||
9038|020|U|prevent vitamin deficiency due to poor diet, certain illnesses,||
9038|021|U|or during pregnancy. Vitamins are important building blocks of||
9038|022|U|the body and help keep you in good health.||
9038|023|B|||
9038|024|H|HOW TO USE:  Take this medication by mouth, usually once daily or||
9038|025|H|as directed. Follow all directions on the product package, or||
9038|026|H|take as directed by your doctor. Do not take more than the||
9038|027|H|recommended dosage. If you have any questions, ask your doctor or||
9038|028|H|pharmacist.||
9038|029|H|   Take this medication regularly in order to get the most||
9038|030|H|benefit from it. To help you remember, take it at the same time||
9038|031|H|each day.||
9038|032|B|||
9038|033|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
9038|034|S|occur. These effects are usually temporary and may disappear as||
9038|035|S|your body adjusts to this medication. If any of these effects||
9038|036|S|last or get worse, tell your doctor or pharmacist promptly.||
9038|037|S|   If your doctor has prescribed this medication, remember that||
9038|038|S|your doctor has judged that the benefit to you is greater than||
9038|039|S|the risk of side effects. Many people using this medication do||
9038|040|S|not have serious side effects.||
9038|041|S|   A very serious allergic reaction to this drug is rare.||
9038|042|S|However, get medical help right away if you notice any symptoms||
9038|043|S|of a serious allergic reaction, including: rash, itching/swelling||
9038|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9038|045|S|breathing.||
9038|046|S|   This is not a complete list of possible side effects. If you||
9038|047|S|notice other effects not listed above, contact your doctor or||
9038|048|S|pharmacist.||
9038|049|S|   In the US -||
9038|050|S|   Call your doctor for medical advice about side effects. You||
9038|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9038|052|S|www.fda.gov/medwatch.||
9038|053|S|   In Canada - Call your doctor for medical advice about side||
9038|054|S|effects. You may report side effects to Health Canada at||
9038|055|S|1-866-234-2345.||
9038|056|B|||
9038|057|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
9038|058|P|pharmacist if you are allergic to any of its ingredients; or to||
9038|059|P|soy/peanut found in some brands; or if you have any other||
9038|060|P|allergies. This product may contain inactive ingredients, which||
9038|061|P|can cause allergic reactions or other problems. Talk to your||
9038|062|P|pharmacist for more details.||
9038|063|P|   Before taking this medication, tell your doctor or pharmacist||
9038|064|P|your medical history, especially of: use/abuse of alcohol, liver||
9038|065|P|problems, stomach/intestinal problems (such as ulcer, colitis).||
9038|066|P|   If your brand of multivitamin also contains folic acid, be||
9038|067|P|sure to tell your doctor or pharmacist if you have vitamin B12||
9038|068|P|deficiency (pernicious anemia) before taking it. Folic acid may||
9038|069|P|affect certain lab tests for vitamin B12 deficiency without||
9038|070|P|treating this anemia. Untreated vitamin B12 deficiency may result||
9038|071|P|in serious nerve problems (such as peripheral neuropathy).||
9038|072|P|Consult your doctor or pharmacist for details.||
9038|073|P|   Before having surgery, tell your doctor or dentist about all||
9038|074|P|the products you use (including prescription drugs,||
9038|075|P|nonprescription drugs, and herbal products).||
9038|076|P|   Tell your doctor if you are pregnant before using this||
9038|077|P|medication.||
9038|078|P|   This medication passes into breast milk. Consult your doctor||
9038|079|P|before breastfeeding.||
9038|080|B|||
9038|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9038|082|I|medications work or increase your risk for serious side effects.||
9038|083|I|This document does not contain all possible drug interactions.||
9038|084|I|Keep a list of all the products you use (including||
9038|085|I|prescription/nonprescription drugs and herbal products) and share||
9038|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
9038|087|I|the dosage of any medicines without your doctor's approval.||
9038|088|I|   If your brand of multivitamin also contains calcium, iron,||
9038|089|I|magnesium, or zinc, then it can decrease the absorption of||
9038|090|I|certain drugs, especially if you take them around the same time.||
9038|091|I|These drugs include bisphosphonates (such as alendronate),||
9038|092|I|levodopa, penicillamine, quinolone antibiotics (such as||
9038|093|I|ciprofloxacin, levofloxacin), tetracycline antibiotics (such as||
9038|094|I|doxycycline, minocycline), thyroid medications (such as||
9038|095|I|levothyroxine), among others. Ask your doctor or pharmacist how||
9038|096|I|long you should wait between doses of this product and your other||
9038|097|I|medications and to find a dosing schedule that works for all your||
9038|098|I|medications.||
9038|099|I|   This medication may interfere with certain lab tests, possibly||
9038|100|I|causing false test results. Make sure lab personnel and all your||
9038|101|I|doctors know you use this drug.||
9038|102|B|||
9038|103|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9038|104|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9038|105|O|poison control center right away. US residents can call||
9038|106|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9038|107|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
9038|108|O|diarrhea.||
9038|109|B|||
9038|110|N|NOTES:  Keep all medical and lab appointments.||
9038|111|N|   Some brands may also contain ingredients such as docusate. Ask||
9038|112|N|your doctor or pharmacist if you have questions about the||
9038|113|N|ingredients in your brand.||
9038|114|N|   This product is not a substitute for a proper diet. Remember||
9038|115|N|that it is best to get your vitamins from healthy foods. Maintain||
9038|116|N|a well-balanced diet and follow any dietary guidelines as||
9038|117|N|directed by your doctor.||
9038|118|B|||
9038|119|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9038|120|D|remember. If it is near the time of the next dose, skip the||
9038|121|D|missed dose. Take your next dose at the regular time. Do not||
9038|122|D|double the dose to catch up.||
9038|123|B|||
9038|124|R|STORAGE:  Store at room temperature away from light and moisture.||
9038|125|R|Do not store in the bathroom. Keep all medications away from||
9038|126|R|children and pets.||
9038|127|R|   Do not flush medications down the toilet or pour them into a||
9038|128|R|drain unless instructed to do so. Properly discard this product||
9038|129|R|when it is expired or no longer needed. Consult your pharmacist||
9038|130|R|or local waste disposal company.||
9038|131|B|||
9038|132|A|Information last revised October 2025.||
9038|133|A|Copyright(c) 2025 First Databank, Inc.||
9038|134|B|||
9039|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9039|002|Z|does NOT have all possible information about this product. This||
9039|003|Z|information does not assure that this product is safe, effective,||
9039|004|Z|or appropriate for you. This information is not individual||
9039|005|Z|medical advice and does not substitute for the advice of your||
9039|006|Z|health care professional. Always ask your health care||
9039|007|Z|professional for complete information about this product and your||
9039|008|Z|specific health needs.||
9039|009|B|||
9039|010|T|TRETINOIN - TOPICAL||
9039|011|F|(tret-ih-NO-in)||
9039|012|B|||
9039|013|C|COMMON BRAND NAME(S): Retin-A||
9039|014|B|||
9039|015|U|USES:  This medication is used to treat acne. It may decrease the||
9039|016|U|number and severity of acne pimples and promote quick healing of||
9039|017|U|pimples that do develop. Tretinoin belongs to a class of||
9039|018|U|medications called retinoids. It works by affecting the growth of||
9039|019|U|skin cells.||
9039|020|B|||
9039|021|V|OTHER USES:  This section contains uses of this drug that are not||
9039|022|V|listed in the approved professional labeling for the drug but||
9039|023|V|that may be prescribed by your health care professional. Use this||
9039|024|V|drug for a condition that is listed in this section only if it||
9039|025|V|has been so prescribed by your health care professional.||
9039|026|V|   Other forms of this medication are used to improve the||
9039|027|V|appearance of the skin and minimize fine wrinkles..||
9039|028|B|||
9039|029|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9039|030|H|from your pharmacist before you start using this medication and||
9039|031|H|each time you get a refill. If you have any questions, ask your||
9039|032|H|doctor or pharmacist||
9039|033|H|   Wash your hands before applying this medication. Gently clean||
9039|034|H|the affected skin with a mild or soapless cleanser and pat dry.||
9039|035|H|Use your fingertips to apply a small amount of medication (about||
9039|036|H|the size of a pea) in a thin layer as directed by your doctor,||
9039|037|H|usually once daily at bedtime. A gauze pad or cotton swab can be||
9039|038|H|used to apply the liquid. For some preparations, you should wait||
9039|039|H|20 to 30 minutes after cleaning your face before applying this||
9039|040|H|medication. Consult the label directions, the Patient Information||
9039|041|H|Leaflet, or your pharmacist if you have any questions.||
9039|042|H|   Use this medication on the skin only. Do not apply to the||
9039|043|H|inner lip area or inside the nose/mouth. Do not apply to cut,||
9039|044|H|scraped, sunburned, or eczema-affected skin.||
9039|045|H|   Avoid getting this medication in your eyes. If this medication||
9039|046|H|gets into your eyes, flush with large amounts of water. Call your||
9039|047|H|doctor if eye irritation develops. Wash your hands after using||
9039|048|H|the medication to avoid accidentally getting it in your eyes.||
9039|049|H|   During the first few weeks of using tretinoin, your acne might||
9039|050|H|appear worse because the medication is working on pimples forming||
9039|051|H|inside the skin. It may take up to 8-12 weeks to notice results||
9039|052|H|from this medication.||
9039|053|H|   Use it regularly in order to get the most benefit from it. To||
9039|054|H|help you remember, use it at the same time each day. Do not use a||
9039|055|H|larger amount or use it more often than recommended. Your skin||
9039|056|H|will not improve any faster, and it will increase the risk of||
9039|057|H|developing redness, peeling and pain.||
9039|058|H|   This medication is available in different strengths and forms||
9039|059|H|(such as gel, cream, solution). The best type of medication for||
9039|060|H|you to use will depend on the condition of your skin and your||
9039|061|H|response to treatment. Tell your doctor if your condition lasts||
9039|062|H|or gets worse.||
9039|063|B|||
9039|064|S|SIDE EFFECTS:  Warmth or stinging may occur right after applying||
9039|065|S|the medication. Skin redness, dryness, itching, scaling, mild||
9039|066|S|burning, or worsening of acne may occur during the first 2 to 4||
9039|067|S|weeks of using the medication. These effects usually decrease||
9039|068|S|with continued use. A daytime moisturizer may be helpful for very||
9039|069|S|dry skin (see Notes). If any of these effects last or get worse,||
9039|070|S|tell your doctor or pharmacist promptly.||
9039|071|S|   Remember that this medication has been prescribed because your||
9039|072|S|doctor has judged that the benefit to you is greater than the||
9039|073|S|risk of side effects. Many people using this medication do not||
9039|074|S|have serious side effects.||
9039|075|S|   Tell your doctor right away if you have any serious side||
9039|076|S|effects, including: blistering/crusting of the skin, severe||
9039|077|S|burning/swelling of the skin, skin discoloration.||
9039|078|S|   A very serious allergic reaction to this drug is rare.||
9039|079|S|However, get medical help right away if you notice any symptoms||
9039|080|S|of a serious allergic reaction, including: rash, itching/swelling||
9039|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9039|082|S|breathing.||
9039|083|S|   This is not a complete list of possible side effects. If you||
9039|084|S|notice other effects not listed above, contact your doctor or||
9039|085|S|pharmacist.||
9039|086|S|   In the US -||
9039|087|S|   Call your doctor for medical advice about side effects. You||
9039|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9039|089|S|www.fda.gov/medwatch.||
9039|090|S|   In Canada - Call your doctor for medical advice about side||
9039|091|S|effects. You may report side effects to Health Canada at||
9039|092|S|1-866-234-2345.||
9039|093|B|||
9039|094|P|PRECAUTIONS:  Before using tretinoin, tell your doctor or||
9039|095|P|pharmacist if you are allergic to it; or to vitamin A-related||
9039|096|P|drugs (other retinoids such as isotretinoin); or if you have any||
9039|097|P|other allergies. This product may contain inactive ingredients||
9039|098|P|(such as fish proteins), which can cause allergic reactions or||
9039|099|P|other problems. Talk to your pharmacist for more details.||
9039|100|P|   Before using this medication, tell your doctor or pharmacist||
9039|101|P|your medical history, especially of: eczema.||
9039|102|P|   This medication may make you more sensitive to the sun. Limit||
9039|103|P|your time in the sun. Avoid tanning booths and sunlamps. Weather||
9039|104|P|extremes such as wind or cold may also be irritating to the skin.||
9039|105|P|Use sunscreen daily and wear protective clothing when outdoors.||
9039|106|P|Tell your doctor right away if you get sunburned or have skin||
9039|107|P|blisters/redness. Wait until your skin has completely recovered||
9039|108|P|from a sunburn before using tretinoin.||
9039|109|P|   Avoid electrolysis, waxing and chemical depilatories for hair||
9039|110|P|removal on the treated areas while using this product.||
9039|111|P|   Before having surgery, tell your doctor or dentist about all||
9039|112|P|the products you use (including prescription drugs,||
9039|113|P|nonprescription drugs, and herbal products).||
9039|114|P|   During pregnancy, this medication should be used only when||
9039|115|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
9039|116|P|benefits with your doctor.||
9039|117|P|   It is unknown if this drug passes into breast milk. Consult||
9039|118|P|your doctor before breastfeeding.||
9039|119|B|||
9039|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9039|121|I|medications work or increase your risk for serious side effects.||
9039|122|I|This document does not contain all possible drug interactions.||
9039|123|I|Keep a list of all the products you use (including||
9039|124|I|prescription/nonprescription drugs and herbal products) and share||
9039|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
9039|126|I|the dosage of any medicines without your doctor's approval.||
9039|127|I|   Avoid using other skin products that are harsh, irritating, or||
9039|128|I|drying on the treated area. These products include hair perming||
9039|129|I|solutions, alcohol/lime/menthol-containing products (such as||
9039|130|I|astringents, toners, shaving lotion), medicated or abrasive soaps||
9039|131|I|or cleansers, soaps and cosmetics with a strong drying effect||
9039|132|I|(such as alpha hydroxy acids, glycolic acid), and products||
9039|133|I|containing sulfur, resorcinol, or salicylic acid.||
9039|134|I|   Benzoyl peroxide can be very irritating and may decrease the||
9039|135|I|effectiveness of tretinoin if the two products are applied at the||
9039|136|I|same time. Talk with your doctor or pharmacist about the safe use||
9039|137|I|of prescription and non-prescription benzoyl peroxide products.||
9039|138|B|||
9039|139|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9039|140|O|has overdosed and has serious symptoms such as passing out or||
9039|141|O|trouble breathing, call 911. Otherwise, call a poison control||
9039|142|O|center right away. US residents can call 1-800-222-1222. Canada||
9039|143|O|residents can call 1-844-764-7669.||
9039|144|B|||
9039|145|N|NOTES:  Do not share this medication with others.||
9039|146|N|   Cosmetics may be used, but clean skin thoroughly before||
9039|147|N|applying the medication.||
9039|148|N|   Some cosmetics and soaps may worsen your acne. Moisturizers||
9039|149|N|may be safe to use. When buying cosmetics, moisturizers or other||
9039|150|N|skin care products, check the label for "non-comedogenic" or||
9039|151|N|"non-acnegenic." These products are unlikely to worsen your acne.||
9039|152|N|Ask your doctor or pharmacist which products are safe to use.||
9039|153|N|Remember, acne is not caused by dirt. Cleaning your skin too||
9039|154|N|often or too vigorously can irritate your skin and worsen acne.||
9039|155|B|||
9039|156|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9039|157|D|If it is near the time of the next dose, skip the missed dose.||
9039|158|D|Use your next dose at the regular time. Do not double the dose to||
9039|159|D|catch up.||
9039|160|B|||
9039|161|R|STORAGE:  Store at room temperature. Keep all medications away||
9039|162|R|from children and pets.||
9039|163|R|   Do not flush medications down the toilet or pour them into a||
9039|164|R|drain unless instructed to do so. Properly discard this product||
9039|165|R|when it is expired or no longer needed. Consult your pharmacist||
9039|166|R|or local waste disposal company.||
9039|167|B|||
9039|168|A|Information last revised July 2025.||
9039|169|A|Copyright(c) 2025 First Databank, Inc.||
9039|170|B|||
9041|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9041|002|Z|does NOT have all possible information about this product. This||
9041|003|Z|information does not assure that this product is safe, effective,||
9041|004|Z|or appropriate for you. This information is not individual||
9041|005|Z|medical advice and does not substitute for the advice of your||
9041|006|Z|health care professional. Always ask your health care||
9041|007|Z|professional for complete information about this product and your||
9041|008|Z|specific health needs.||
9041|009|B|||
9041|010|T|AMANTADINE - ORAL||
9041|011|F|(a-MAN-ta-deen)||
9041|012|B|||
9041|013|C|COMMON BRAND NAME(S): Symmetrel||
9041|014|B|||
9041|015|U|USES:  Amantadine is used to treat Parkinson's disease, as well||
9041|016|U|as side effects caused by drugs (such as drug-induced||
9041|017|U|extrapyramidal symptoms), chemicals, and other medical||
9041|018|U|conditions. In these cases, this medication may help to improve||
9041|019|U|your range of motion and ability to exercise. For the treatment||
9041|020|U|of these conditions, amantadine is believed to work by restoring||
9041|021|U|the balance of natural chemicals (neurotransmitters) in the||
9041|022|U|brain.||
9041|023|U|   Amantadine is used to prevent or treat a certain type of flu||
9041|024|U|(influenza A). If you have been infected with the flu, this||
9041|025|U|medication may help make your symptoms less severe and shorten||
9041|026|U|the time it will take you to get better. Taking amantadine if you||
9041|027|U|have been or will be exposed to the flu may help to prevent you||
9041|028|U|from getting the flu. This medication is an antiviral that is||
9041|029|U|believed to work by stopping growth of the flu virus. This||
9041|030|U|medication is not a vaccine. To increase the chance that you will||
9041|031|U|not get the flu, it is important to get a flu shot once a year at||
9041|032|U|the beginning of every flu season, if possible.||
9041|033|U|   Based on the recommendation from the Centers for Disease||
9041|034|U|Control (CDC) in the US, amantadine should not be used to treat||
9041|035|U|or prevent influenza A because the current influenza A virus in||
9041|036|U|the United States and Canada is resistant to this medication. For||
9041|037|U|more details, talk to your doctor or pharmacist.||
9041|038|B|||
9041|039|H|HOW TO USE:  Take this medication by mouth with or without food||
9041|040|H|as directed by your doctor, usually once or twice daily. If you||
9041|041|H|are taking this medication twice a day and have trouble sleeping||
9041|042|H|after taking it, take the second dose several hours before||
9041|043|H|bedtime.||
9041|044|H|   If you are using the liquid form of this medication, carefully||
9041|045|H|measure the dose using a special measuring device/spoon. Do not||
9041|046|H|use a household spoon because you may not get the correct dose.||
9041|047|H|   The dosage is based on your medical condition and response to||
9041|048|H|treatment. Children's dosage is also based on weight. Do not take||
9041|049|H|more than prescribed by your doctor.||
9041|050|H|   This medication works best when the amount of medicine in your||
9041|051|H|body is kept at a constant level. Take this medication at evenly||
9041|052|H|spaced intervals throughout the day and night.||
9041|053|H|   If you are taking amantadine for a viral infection, begin||
9041|054|H|taking it as soon as possible. Continue to take this medication||
9041|055|H|until the full prescribed amount is finished, even if symptoms||
9041|056|H|disappear after a few days. Stopping the medication too early may||
9041|057|H|result in a return of the infection.||
9041|058|H|   In Parkinson's disease, the effects of the medication may not||
9041|059|H|be noticed for several weeks. Do not suddenly stop taking the||
9041|060|H|medication because symptoms or side effects may get worse. Your||
9041|061|H|doctor may want to reduce your dose gradually. This medication||
9041|062|H|may not work as well after it has been taken for several months.||
9041|063|H|Tell your doctor if this medication stops working well.||
9041|064|B|||
9041|065|S|SIDE EFFECTS:  Blurred vision, nausea, stomach upset, drowsiness,||
9041|066|S|dizziness, headache, dry mouth, constipation, nervousness, or||
9041|067|S|trouble sleeping may occur. If any of these effects last or get||
9041|068|S|worse, tell your doctor or pharmacist promptly.||
9041|069|S|   To reduce the risk of dizziness and lightheadedness, get up||
9041|070|S|slowly when rising from a sitting or lying position.||
9041|071|S|   Remember that this medication has been prescribed because your||
9041|072|S|doctor has judged that the benefit to you is greater than the||
9041|073|S|risk of side effects. Many people using this medication do not||
9041|074|S|have serious side effects.||
9041|075|S|   Tell your doctor right away if you have any serious side||
9041|076|S|effects, including: purplish-red blotchy spots on the skin,||
9041|077|S|swelling of the ankles/feet, difficulty urinating, vision changes||
9041|078|S|(such as vision loss), eye pain, shortness of breath, mental/mood||
9041|079|S|changes (such as depression, suicidal thoughts/attempts), muscle||
9041|080|S|stiffness, uncontrolled muscle movements, unusual sweating, fast||
9041|081|S|heartbeat, unexplained fever, unusual strong urges (such as||
9041|082|S|increased gambling, increased sexual urges).||
9041|083|S|   Get medical help right away if you have any very serious side||
9041|084|S|effects, including: seizures.||
9041|085|S|   Some people taking amantadine have fallen asleep suddenly||
9041|086|S|during their usual daily activities (such as talking on the||
9041|087|S|phone, driving). In some cases, sleep occurred without any||
9041|088|S|feelings of drowsiness beforehand. This sleep effect may occur||
9041|089|S|anytime during treatment with amantadine even if you have used||
9041|090|S|this medication for a long time. If you experience increased||
9041|091|S|sleepiness or fall asleep during the day, do not drive or take||
9041|092|S|part in other possibly dangerous activities until you have||
9041|093|S|discussed this effect with your doctor. Your risk of this sleep||
9041|094|S|effect is increased by using alcohol or other medications that||
9041|095|S|can make you drowsy. See also Precautions section.||
9041|096|S|   A very serious allergic reaction to this drug is rare.||
9041|097|S|However, get medical help right away if you notice any symptoms||
9041|098|S|of a serious allergic reaction, including: rash, itching/swelling||
9041|099|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9041|100|S|breathing.||
9041|101|S|   This is not a complete list of possible side effects. If you||
9041|102|S|notice other effects not listed above, contact your doctor or||
9041|103|S|pharmacist.||
9041|104|S|   In the US -||
9041|105|S|   Call your doctor for medical advice about side effects. You||
9041|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9041|107|S|www.fda.gov/medwatch.||
9041|108|S|   In Canada - Call your doctor for medical advice about side||
9041|109|S|effects. You may report side effects to Health Canada at||
9041|110|S|1-866-234-2345.||
9041|111|B|||
9041|112|P|PRECAUTIONS:  Before taking amantadine, tell your doctor or||
9041|113|P|pharmacist if you are allergic to it; or to rimantadine; or if||
9041|114|P|you have any other allergies. This product may contain inactive||
9041|115|P|ingredients, which can cause allergic reactions or other||
9041|116|P|problems. Talk to your pharmacist for more details.||
9041|117|P|   Before using this medication, tell your doctor or pharmacist||
9041|118|P|your medical history, especially of: glaucoma, swelling of||
9041|119|P|arms/legs (peripheral edema), heart problems (such as heart||
9041|120|P|failure), blood pressure problems (such as dizziness when||
9041|121|P|standing), kidney disease, liver disease, mental/mood conditions||
9041|122|P|(such as depression, psychosis), seizures, a certain skin||
9041|123|P|condition (eczematoid dermatitis).||
9041|124|P|   This drug may make you dizzy or drowsy or blur your vision.||
9041|125|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9041|126|P|drowsy. Do not drive, use machinery, or do anything that needs||
9041|127|P|alertness or clear vision until you can do it safely. Limit||
9041|128|P|alcoholic beverages. Talk to your doctor if you are using||
9041|129|P|marijuana (cannabis). See also Side Effects section.||
9041|130|P|   If you are taking this medication for Parkinson's disease, be||
9041|131|P|careful not to overdo physical activity as your condition||
9041|132|P|improves because this may increase your risk of falls. Consult||
9041|133|P|your doctor about a plan to gradually increase your physical||
9041|134|P|activity as symptoms improve.||
9041|135|P|   Older adults may be at a greater risk for side effects while||
9041|136|P|taking this drug.||
9041|137|P|   During pregnancy, this medication should be used only when||
9041|138|P|clearly needed. Discuss the risks and benefits with your doctor.||
9041|139|P|   This drug passes into breast milk and may have undesirable||
9041|140|P|effects on a nursing infant. Consult with your doctor before||
9041|141|P|breastfeeding.||
9041|142|B|||
9041|143|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9041|144|I|medications work or increase your risk for serious side effects.||
9041|145|I|This document does not contain all possible drug interactions.||
9041|146|I|Keep a list of all the products you use (including||
9041|147|I|prescription/nonprescription drugs and herbal products) and share||
9041|148|I|it with your doctor and pharmacist. Do not start, stop, or change||
9041|149|I|the dosage of any medicines without your doctor's approval.||
9041|150|I|   Amantadine may interfere with the effect of certain vaccines,||
9041|151|I|such as flu vaccine inhaled through the nose. However, you may||
9041|152|I|get a flu shot (flu vaccine given by injection) if recommended by||
9041|153|I|your doctor.||
9041|154|B|||
9041|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9041|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9041|157|O|poison control center right away. US residents can call||
9041|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9041|159|O|Symptoms of overdose may include fast/irregular heartbeats,||
9041|160|O|severe drowsiness, shortness of breath, change in the amount of||
9041|161|O|urine, mental/mood changes (such as anxiety, aggression,||
9041|162|O|confusion, hallucinations), seizures.||
9041|163|B|||
9041|164|N|NOTES:  Do not share this product with others.||
9041|165|B|||
9041|166|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9041|167|D|remember. If it is near the time of the next dose, skip the||
9041|168|D|missed dose. Take your next dose at the regular time. Do not||
9041|169|D|double the dose to catch up.||
9041|170|B|||
9041|171|R|STORAGE:  Store at room temperature away from light and moisture.||
9041|172|R|Do not store in the bathroom. Keep all medications away from||
9041|173|R|children and pets.||
9041|174|R|   Do not flush medications down the toilet or pour them into a||
9041|175|R|drain unless instructed to do so. Properly discard this product||
9041|176|R|when it is expired or no longer needed. Consult your pharmacist||
9041|177|R|or local waste disposal company.||
9041|178|B|||
9041|179|A|Information last revised July 2025.||
9041|180|A|Copyright(c) 2025 First Databank, Inc.||
9041|181|B|||
9043|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9043|002|Z|does NOT have all possible information about this product. This||
9043|003|Z|information does not assure that this product is safe, effective,||
9043|004|Z|or appropriate for you. This information is not individual||
9043|005|Z|medical advice and does not substitute for the advice of your||
9043|006|Z|health care professional. Always ask your health care||
9043|007|Z|professional for complete information about this product and your||
9043|008|Z|specific health needs.||
9043|009|B|||
9043|010|T|TORSEMIDE - ORAL||
9043|011|F|(TOR-seh-mide)||
9043|012|B|||
9043|013|C|COMMON BRAND NAME(S): Demadex, Soaanz||
9043|014|B|||
9043|015|U|USES:  Torsemide is used to reduce extra fluid in the body||
9043|016|U|(edema) caused by conditions such as heart failure, liver||
9043|017|U|disease, and kidney disease. This can lessen symptoms such as||
9043|018|U|shortness of breath and swelling in your arms, legs, and abdomen.||
9043|019|U|   This drug is also used to treat high blood pressure. Lowering||
9043|020|U|high blood pressure helps prevent strokes, heart attacks, and||
9043|021|U|kidney problems.||
9043|022|U|   Torsemide is a "water pill" (diuretic) that causes you to make||
9043|023|U|more urine. This helps your body get rid of extra water and salt.||
9043|024|B|||
9043|025|H|HOW TO USE:  Take this medication by mouth with or without food||
9043|026|H|as directed by your doctor, usually once daily. It is best to||
9043|027|H|avoid taking this medication within 4 hours of your bedtime to||
9043|028|H|prevent having to get up to urinate.||
9043|029|H|   The dosage is based on your medical condition and response to||
9043|030|H|treatment. Do not increase your dose or take it more often than||
9043|031|H|directed.||
9043|032|H|   Take this medication regularly to get the most benefit from||
9043|033|H|it. To help you remember, take it at the same time each day as||
9043|034|H|directed. Keep taking this medication even if you feel well. Most||
9043|035|H|people with high blood pressure do not feel sick. Generally, it||
9043|036|H|may take 4 to 6 weeks, and sometimes up to 12 weeks, before the||
9043|037|H|full blood pressure-lowering effect is seen. Do not stop taking||
9043|038|H|this medication without consulting your doctor.||
9043|039|H|   If you also take certain drugs to lower your cholesterol (bile||
9043|040|H|acid-binding resins such as cholestyramine or colestipol), take||
9043|041|H|torsemide at least 1 hour before or at least 4 to 6 hours after||
9043|042|H|these medications.||
9043|043|H|   Tell your doctor if your condition does not get better or if||
9043|044|H|it gets worse (for example, your blood pressure readings remain||
9043|045|H|high or increase).||
9043|046|B|||
9043|047|S|SIDE EFFECTS:  Dizziness or headache may occur as your body||
9043|048|S|adjusts to the medication. If either of these effects lasts or||
9043|049|S|gets worse, tell your doctor or pharmacist promptly.||
9043|050|S|   To reduce the risk of dizziness and lightheadedness, get up||
9043|051|S|slowly when rising from a sitting or lying position.||
9043|052|S|   Remember that this medication has been prescribed because your||
9043|053|S|doctor has judged that the benefit to you is greater than the||
9043|054|S|risk of side effects. Many people using this medication do not||
9043|055|S|have serious side effects.||
9043|056|S|   This medication may cause dehydration and electrolyte||
9043|057|S|imbalance. Tell your doctor right away if you have any symptoms||
9043|058|S|of dehydration or electrolyte imbalance, including unusual dry||
9043|059|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
9043|060|S|heartbeat, or confusion.||
9043|061|S|   Tell your doctor right away if you have any serious side||
9043|062|S|effects, including: fainting, signs of kidney problems (such as||
9043|063|S|change in the amount of urine),||
9043|064|S|numbness/tingling/pain/redness/swelling of the arms/legs, hearing||
9043|065|S|changes (such as ringing in the ears, temporary or permanent||
9043|066|S|decreased hearing/deafness).||
9043|067|S|   A very serious allergic reaction to this drug is rare.||
9043|068|S|However, get medical help right away if you notice any symptoms||
9043|069|S|of a serious allergic reaction, including: rash, itching/swelling||
9043|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9043|071|S|breathing.||
9043|072|S|   This is not a complete list of possible side effects. If you||
9043|073|S|notice other effects not listed above, contact your doctor or||
9043|074|S|pharmacist.||
9043|075|S|   In the US -||
9043|076|S|   Call your doctor for medical advice about side effects. You||
9043|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9043|078|S|www.fda.gov/medwatch.||
9043|079|S|   In Canada - Call your doctor for medical advice about side||
9043|080|S|effects. You may report side effects to Health Canada at||
9043|081|S|1-866-234-2345.||
9043|082|B|||
9043|083|P|PRECAUTIONS:  Before taking torsemide, tell your doctor or||
9043|084|P|pharmacist if you are allergic to it; or if you have any other||
9043|085|P|allergies. This product may contain inactive ingredients, which||
9043|086|P|can cause allergic reactions or other problems. Talk to your||
9043|087|P|pharmacist for more details.||
9043|088|P|   Before using this medication, tell your doctor or pharmacist||
9043|089|P|your medical history, especially of: kidney problems, liver||
9043|090|P|problems, inability to make urine, gout.||
9043|091|P|   If you have diabetes, torsemide may rarely affect your blood||
9043|092|P|sugar. Check your blood sugar regularly as directed and share the||
9043|093|P|results with your doctor. Your doctor may need to adjust your||
9043|094|P|diabetes medication, exercise program, or diet.||
9043|095|P|   Torsemide may reduce the potassium level in your blood. Your||
9043|096|P|doctor may instruct you to add potassium-rich foods to your diet||
9043|097|P|(such as bananas, orange juice) or prescribe potassium||
9043|098|P|supplements to prevent potassium loss. Ask your doctor for more||
9043|099|P|details.||
9043|100|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9043|101|P|can make you more dizzy. Do not drive, use machinery, or do||
9043|102|P|anything that needs alertness until you can do it safely. Limit||
9043|103|P|alcoholic beverages. Talk to your doctor if you are using||
9043|104|P|marijuana (cannabis).||
9043|105|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
9043|106|P|and cause you to feel lightheaded. Tell your doctor if you have||
9043|107|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
9043|108|P|of fluids unless your doctor tells you not to.||
9043|109|P|   Before having surgery, tell your doctor or dentist about all||
9043|110|P|the products you use (including prescription drugs,||
9043|111|P|nonprescription drugs, and herbal products).||
9043|112|P|   Older adults may be more sensitive to the effects of this||
9043|113|P|drug, especially dizziness and water/mineral loss.||
9043|114|P|   During pregnancy, this drug should be used only when clearly||
9043|115|P|needed. Discuss the risks and benefits with your doctor.||
9043|116|P|   It is unknown if this drug passes into breast milk. Consult||
9043|117|P|your doctor before breastfeeding.||
9043|118|B|||
9043|119|I|DRUG INTERACTIONS:  See also the How to Use section.||
9043|120|I|   Drug interactions may change how your medications work or||
9043|121|I|increase your risk for serious side effects. This document does||
9043|122|I|not contain all possible drug interactions. Keep a list of all||
9043|123|I|the products you use (including prescription/nonprescription||
9043|124|I|drugs and herbal products) and share it with your doctor and||
9043|125|I|pharmacist. Do not start, stop, or change the dosage of any||
9043|126|I|medicines without your doctor's approval.||
9043|127|I|   Some products that may interact with this drug include:||
9043|128|I|desmopressin, lithium.||
9043|129|I|   Some products have ingredients that could raise your blood||
9043|130|I|pressure or worsen your swelling. Tell your pharmacist what||
9043|131|I|products you are using, and ask how to use them safely||
9043|132|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
9043|133|I|ibuprofen/naproxen).||
9043|134|B|||
9043|135|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9043|136|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9043|137|O|poison control center right away. US residents can call||
9043|138|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9043|139|O|Symptoms of overdose may include: fainting, severe weakness, a||
9043|140|O|severe decrease in the amount of urine.||
9043|141|B|||
9043|142|N|NOTES:  Do not share this medication with others.||
9043|143|N|   Lifestyle changes that may help this medication work better||
9043|144|N|include exercising, stopping smoking, reducing stress, and||
9043|145|N|changing your diet. Consult your doctor for more details.||
9043|146|N|   Lab and/or medical tests (such as kidney function, blood||
9043|147|N|mineral levels such as potassium) should be done while you are||
9043|148|N|taking this medication. Keep all medical and lab appointments.||
9043|149|N|Consult your doctor for more details.||
9043|150|N|   Check your blood pressure regularly while taking this||
9043|151|N|medication. Learn how to monitor your own blood pressure at home,||
9043|152|N|and share the results with your doctor.||
9043|153|B|||
9043|154|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9043|155|D|remember. If it is near the time of the next dose, skip the||
9043|156|D|missed dose. Take your next dose at the regular time. Do not||
9043|157|D|double the dose to catch up.||
9043|158|B|||
9043|159|R|STORAGE:  Store at room temperature away from light and moisture.||
9043|160|R|Do not store in the bathroom. Keep all medications away from||
9043|161|R|children and pets.||
9043|162|R|   Do not flush medications down the toilet or pour them into a||
9043|163|R|drain unless instructed to do so. Properly discard this product||
9043|164|R|when it is expired or no longer needed. Consult your pharmacist||
9043|165|R|or local waste disposal company.||
9043|166|B|||
9043|167|A|Information last revised May 2024.||
9043|168|A|Copyright(c) 2025 First Databank, Inc.||
9043|169|B|||
9045|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9045|002|Z|does NOT have all possible information about this product. This||
9045|003|Z|information does not assure that this product is safe, effective,||
9045|004|Z|or appropriate for you. This information is not individual||
9045|005|Z|medical advice and does not substitute for the advice of your||
9045|006|Z|health care professional. Always ask your health care||
9045|007|Z|professional for complete information about this product and your||
9045|008|Z|specific health needs.||
9045|009|B|||
9045|010|T|MOCLOBEMIDE - ORAL||
9045|011|F|(mow-KLO-bem-ide)||
9045|012|B|||
9045|013|W|WARNING:  Antidepressant medications are used to treat a variety||
9045|014|W|of conditions, including depression and other mental/mood||
9045|015|W|disorders. These medications can help prevent suicidal||
9045|016|W|thoughts/attempts and provide other important benefits. However,||
9045|017|W|studies have shown that a small number of people (especially||
9045|018|W|people younger than 25) who take antidepressants for any||
9045|019|W|condition may experience worsening depression, other mental/mood||
9045|020|W|symptoms, or suicidal thoughts/attempts. It is very important to||
9045|021|W|talk with the doctor about the risks and benefits of||
9045|022|W|antidepressant medication (especially for people younger than||
9045|023|W|25), even if treatment is not for a mental/mood condition.||
9045|024|W|   Tell the doctor right away if you notice worsening||
9045|025|W|depression/other psychiatric conditions, unusual behavior changes||
9045|026|W|(including possible suicidal thoughts/attempts), or other||
9045|027|W|mental/mood changes (including new/worsening anxiety, panic||
9045|028|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
9045|029|W|impulsive actions, severe restlessness, very rapid speech). Be||
9045|030|W|especially watchful for these symptoms when a new antidepressant||
9045|031|W|is started or when the dose is changed.||
9045|032|B|||
9045|033|U|USES:  This medication is used to treat depression. Moclobemide||
9045|034|U|belongs to a class of drugs known as monoamine oxidase inhibitors||
9045|035|U|(MAO inhibitors). It works by helping to restore the balance of||
9045|036|U|certain natural substances in the brain.||
9045|037|B|||
9045|038|H|HOW TO USE:  Take this medication by mouth as directed by your||
9045|039|H|doctor, usually twice daily immediately after meals. The dosage||
9045|040|H|is based on your medical condition and response to treatment.||
9045|041|H|   To reduce your risk of side effects, your doctor may start you||
9045|042|H|at a low dose and gradually increase your dose. Once your||
9045|043|H|condition improves and you are better for a while, your doctor||
9045|044|H|may work with you to reduce your regular dose. Follow your||
9045|045|H|doctor's instructions carefully. Do not take more or less||
9045|046|H|medication or take it more often than prescribed. Your condition||
9045|047|H|will not improve any faster and your risk of side effects will||
9045|048|H|increase.||
9045|049|H|   Use this medication regularly in order to get the most benefit||
9045|050|H|from it. To help you remember, use it at the same times each day.||
9045|051|H|It may take several weeks for the full benefits of this||
9045|052|H|medication to be noticed. Do not stop taking this medication||
9045|053|H|without consulting your doctor.||
9045|054|H|   If you suddenly stop using this medication, you may have||
9045|055|H|withdrawal symptoms (such as restlessness, confusion,||
9045|056|H|hallucinations, headache, weakness, and diarrhea). To help||
9045|057|H|prevent withdrawal, your doctor may lower your dose slowly.||
9045|058|H|Withdrawal is more likely if you have used moclobemide for a long||
9045|059|H|time or in high doses. Tell your doctor or pharmacist right away||
9045|060|H|if you have withdrawal.||
9045|061|H|   Other MAO inhibitors (such as phenelzine, isocarboxazid) have||
9045|062|H|cause very serious (sometimes fatal) attacks of very high blood||
9045|063|H|pressure when taken with foods and beverages high in tyramine.||
9045|064|H|Depending on your medical history, your doctor may direct you to||
9045|065|H|limit your intake of tyramine while you are taking this medicine||
9045|066|H|and for 2 weeks after the last dose. Consult your doctor or||
9045|067|H|pharmacist for more details.||
9045|068|H|   Tell your doctor if your condition lasts or gets worse.||
9045|069|B|||
9045|070|S|SIDE EFFECTS:  See also Warning section.||
9045|071|S|   Dizziness, drowsiness, headache, constipation, dry mouth, loss||
9045|072|S|of appetite, or change in sexual ability/interest may occur. If||
9045|073|S|any of these effects last or get worse, tell your doctor or||
9045|074|S|pharmacist promptly.||
9045|075|S|   To reduce the risk of dizziness and lightheadedness, get up||
9045|076|S|slowly when rising from a sitting or lying position.||
9045|077|S|   Remember that this medication has been prescribed because your||
9045|078|S|doctor has judged that the benefit to you is greater than the||
9045|079|S|risk of side effects. Many people using this medication do not||
9045|080|S|have serious side effects.||
9045|081|S|   Tell your doctor right away if you have any serious side||
9045|082|S|effects, including: stomach pain, restlessness, shaking (tremor),||
9045|083|S|severe headache, fast/pounding/irregular/slow heartbeat,||
9045|084|S|seizures.||
9045|085|S|   Get medical help right away if you have any very serious side||
9045|086|S|effects, including: eye pain/swelling/redness, widened pupils,||
9045|087|S|vision changes (such as seeing rainbows around lights at night,||
9045|088|S|double/blurred vision).||
9045|089|S|   This medication may increase serotonin and rarely cause a very||
9045|090|S|serious condition called serotonin syndrome/toxicity. The risk||
9045|091|S|increases if you are also taking other drugs that increase||
9045|092|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
9045|093|S|take (see Drug Interactions section). Get medical help right away||
9045|094|S|if you develop some of the following symptoms: fast heartbeat,||
9045|095|S|hallucinations, loss of coordination, severe dizziness, severe||
9045|096|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
9045|097|S|unusual agitation/restlessness.||
9045|098|S|   A very serious allergic reaction to this drug is rare.||
9045|099|S|However, get medical help right away if you notice any symptoms||
9045|100|S|of a serious allergic reaction, including: rash, itching/swelling||
9045|101|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9045|102|S|breathing.||
9045|103|S|   This is not a complete list of possible side effects. If you||
9045|104|S|notice other effects not listed above, contact your doctor or||
9045|105|S|pharmacist.||
9045|106|S|   In the US -||
9045|107|S|   Call your doctor for medical advice about side effects. You||
9045|108|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9045|109|S|www.fda.gov/medwatch.||
9045|110|S|   In Canada - Call your doctor for medical advice about side||
9045|111|S|effects. You may report side effects to Health Canada at||
9045|112|S|1-866-234-2345.||
9045|113|B|||
9045|114|P|PRECAUTIONS:  Before taking moclobemide, tell your doctor or||
9045|115|P|pharmacist if you are allergic to it; or if you have any other||
9045|116|P|allergies. This product may contain inactive ingredients, which||
9045|117|P|can cause allergic reactions or other problems. Talk to your||
9045|118|P|pharmacist for more details.||
9045|119|P|   Before using this medication, tell your doctor or pharmacist||
9045|120|P|your medical history, especially of: a certain adrenal gland||
9045|121|P|tumor (pheochromocytoma), cerebrovascular disease (such as||
9045|122|P|stroke), high blood pressure, history of severe/frequent||
9045|123|P|headaches, liver problems, personal/family history of mental/mood||
9045|124|P|disorders (such as schizophrenia, bipolar disorder), heart||
9045|125|P|disease (such as heart failure, heart attack, coronary artery||
9045|126|P|disease), kidney disease, certain nervous system diseases||
9045|127|P|(Parkinson's disease, seizures), overactive thyroid||
9045|128|P|(hyperthyroidism), personal or family history of glaucoma||
9045|129|P|(angle-closure type).||
9045|130|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9045|131|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9045|132|P|machinery, or do anything that needs alertness until you can do||
9045|133|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
9045|134|P|are using marijuana (cannabis).||
9045|135|P|   Before having surgery or any procedures requiring use of||
9045|136|P|contrast dye (such as myelography), tell your doctor or dentist||
9045|137|P|about all the products you use (including prescription drugs,||
9045|138|P|nonprescription drugs, and herbal products). You may need to stop||
9045|139|P|taking this drug beforehand. Follow your doctor's instructions||
9045|140|P|carefully.||
9045|141|P|   In people with heart disease, this medication may prevent you||
9045|142|P|from feeling the chest pain you would normally experience during||
9045|143|P|a heart attack or with other heart problems (such as angina),||
9045|144|P|making it more difficult to know when you need emergency medical||
9045|145|P|attention. To reduce this risk, people with heart disease should||
9045|146|P|avoid strenuous exercise while taking this medication.||
9045|147|P|   If you have diabetes, moclobemide may lower your blood sugar.||
9045|148|P|Check your blood sugar regularly, and share the results with your||
9045|149|P|doctor. Tell your doctor right away if you have symptoms of low||
9045|150|P|blood sugar such as sudden sweating, shaking, fast heartbeat,||
9045|151|P|hunger, blurred vision, dizziness, or tingling hands/feet. Your||
9045|152|P|doctor may need to adjust your diabetes medication, exercise||
9045|153|P|program, or diet.||
9045|154|P|   Older adults may be more sensitive to the side effects of this||
9045|155|P|drug, especially the effects on blood pressure.||
9045|156|P|   During pregnancy, this medication should be used only when||
9045|157|P|clearly needed. Discuss the risks and benefits with your doctor.||
9045|158|P|   Since untreated mental/mood problems (such as depression) can||
9045|159|P|be a serious condition, do not stop taking this medication unless||
9045|160|P|directed by your doctor. If you are planning pregnancy, become||
9045|161|P|pregnant, or think you may be pregnant, immediately discuss with||
9045|162|P|your doctor the benefits and risks of using this medication||
9045|163|P|during pregnancy.||
9045|164|P|   This medication passes into breast milk. Breastfeeding is not||
9045|165|P|recommended while using this medication. Consult your doctor||
9045|166|P|before breastfeeding.||
9045|167|B|||
9045|168|I|DRUG INTERACTIONS:  See also How to Use section.||
9045|169|I|   Drug interactions may change how your medications work or||
9045|170|I|increase your risk for serious side effects. This document does||
9045|171|I|not contain all possible drug interactions. Keep a list of all||
9045|172|I|the products you use (including prescription/nonprescription||
9045|173|I|drugs and herbal products) and share it with your doctor and||
9045|174|I|pharmacist. Do not start, stop, or change the dosage of any||
9045|175|I|medicines without your doctor's approval.||
9045|176|I|   Some products that may interact with this drug include: other||
9045|177|I|antidepressants (including mirtazapine, nefazodone, TCAs such as||
9045|178|I|amitriptyline/nortriptyline), appetite suppressants (such as||
9045|179|I|diethylpropion), drugs for attention deficit disorder (such as||
9045|180|I|atomoxetine, methylphenidate), apraclonidine, bupropion,||
9045|181|I|buspirone, cyclobenzaprine, deutetrabenazine, dextromethorphan,||
9045|182|I|herbal products (such as ginseng, ephedra/ma huang), certain||
9045|183|I|drugs for high blood pressure (such as guanethidine, methyldopa),||
9045|184|I|other MAO inhibitors (isocarboxazid, linezolid, metaxalone,||
9045|185|I|methylene blue, phenelzine, procarbazine, rasagiline, safinamide,||
9045|186|I|selegiline, tranylcypromine), metoclopramide, certain opioid||
9045|187|I|medications (such as fentanyl, meperidine, methadone,||
9045|188|I|tapentadol), certain drugs for Parkinson's disease (such as||
9045|189|I|levodopa, entacapone, tolcapone), papaverine, street drugs (such||
9045|190|I|as LSD, mescaline), stimulants (such as amphetamines, cocaine,||
9045|191|I|ephedrine, epinephrine, phenylalanine), tetrabenazine, tramadol,||
9045|192|I|tyrosine, tryptophan, valbenazine.||
9045|193|I|   The risk of serotonin syndrome/toxicity increases if you are||
9045|194|I|also taking other drugs that increase serotonin. Examples include||
9045|195|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
9045|196|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
9045|197|I|SNRIs such as duloxetine/venlafaxine), maprotiline, trimipramine,||
9045|198|I|"triptan" migraine drugs (such as sumatriptan, rizatriptan),||
9045|199|I|among others. The risk of serotonin syndrome/toxicity may be more||
9045|200|I|likely when you start or increase the dose of these drugs.||
9045|201|I|   Tell your doctor or pharmacist if you are using any of these||
9045|202|I|medications before, during, or within 2 weeks after treatment||
9045|203|I|with moclobemide. Tell your doctor or pharmacist if you have||
9045|204|I|taken fluoxetine during at least 5 weeks before starting||
9045|205|I|moclobemide. Discuss with your doctor how much time to wait||
9045|206|I|between starting or stopping any of these drugs and taking||
9045|207|I|moclobemide.||
9045|208|I|   Other medications can affect the removal of moclobemide from||
9045|209|I|your body, which may affect how moclobemide works. Examples||
9045|210|I|include azole antifungals (such as itraconazole), cimetidine,||
9045|211|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
9045|212|I|rifabutin), ritonavir, St. John's wort, drugs used to treat||
9045|213|I|seizures (such as carbamazepine, phenytoin), among others.||
9045|214|I|   Tell your doctor or pharmacist if you are taking other||
9045|215|I|products that cause drowsiness such as opioid pain or cough||
9045|216|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9045|217|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9045|218|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9045|219|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
9045|220|I|diphenhydramine).||
9045|221|I|   Check the labels on all your medicines (such as allergy,||
9045|222|I|cough-and-cold products, diet pills) because they may contain||
9045|223|I|dextromethorphan, decongestants, stimulants, or ingredients that||
9045|224|I|may cause drowsiness. Ask your pharmacist about using those||
9045|225|I|products safely.||
9045|226|B|||
9045|227|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9045|228|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9045|229|O|poison control center right away. US residents can call||
9045|230|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9045|231|O|Symptoms of overdose may include: confusion, trouble speaking,||
9045|232|O|seizures.||
9045|233|B|||
9045|234|N|NOTES:  Do not share this medication with others.||
9045|235|N|   Lab and/or medical tests (such as blood pressure) should be||
9045|236|N|done while you are taking this medication. Keep all medical and||
9045|237|N|lab appointments. Consult your doctor for more details.||
9045|238|B|||
9045|239|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9045|240|D|remember. If it is near the time of the next dose, skip the||
9045|241|D|missed dose. Take your next dose at the regular time. Do not||
9045|242|D|double the dose to catch up.||
9045|243|B|||
9045|244|R|STORAGE:  Store at room temperature away from light and moisture.||
9045|245|R|Do not store in the bathroom. Keep all medications away from||
9045|246|R|children and pets.||
9045|247|R|   Do not flush medications down the toilet or pour them into a||
9045|248|R|drain unless instructed to do so. Properly discard this product||
9045|249|R|when it is expired or no longer needed. Consult your pharmacist||
9045|250|R|or local waste disposal company.||
9045|251|B|||
9045|252|M|MEDICAL ALERT:  Your condition can cause complications in a||
9045|253|M|medical emergency. For information about enrolling in MedicAlert,||
9045|254|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9045|255|B|||
9045|256|A|Information last revised July 2025.||
9045|257|A|Copyright(c) 2025 First Databank, Inc.||
9045|258|B|||
9046|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9046|002|Z|does NOT have all possible information about this product. This||
9046|003|Z|information does not assure that this product is safe, effective,||
9046|004|Z|or appropriate for you. This information is not individual||
9046|005|Z|medical advice and does not substitute for the advice of your||
9046|006|Z|health care professional. Always ask your health care||
9046|007|Z|professional for complete information about this product and your||
9046|008|Z|specific health needs.||
9046|009|B|||
9046|010|T|CYTARABINE - INJECTION||
9046|011|F|(sye-TAIR-uh-bean)||
9046|012|B|||
9046|013|C|COMMON BRAND NAME(S): Cytosar-U, Tarabine PFS||
9046|014|B|||
9046|015|W|WARNING:  This medication decreases bone marrow function, an||
9046|016|W|effect that may lead to a low number of blood cells such as red||
9046|017|W|cells, white cells, and platelets. This effect can cause anemia,||
9046|018|W|decrease your body's ability to fight an infection, or cause easy||
9046|019|W|bruising/bleeding. Tell your doctor right away if you develop any||
9046|020|W|of the following symptoms: unusual tiredness, pale skin, signs of||
9046|021|W|infection (such as sore throat that doesn't go away, fever,||
9046|022|W|chills), easy bruising/bleeding.||
9046|023|B|||
9046|024|U|USES:  Cytarabine is used to treat various types of cancer. It is||
9046|025|U|a chemotherapy drug that works by slowing or stopping cancer cell||
9046|026|U|growth.||
9046|027|B|||
9046|028|H|HOW TO USE:  This medication is usually given by injection into a||
9046|029|H|vein by a health care professional. It may also be given by other||
9046|030|H|methods of injection depending upon your medical condition. The||
9046|031|H|dosage is based on your medical condition, body size, and||
9046|032|H|response to treatment.||
9046|033|H|   Unless your doctor instructs you otherwise, drink plenty of||
9046|034|H|fluids while using this medication. This helps your kidneys||
9046|035|H|remove the drug from your body and may help you avoid some of the||
9046|036|H|side effects.||
9046|037|B|||
9046|038|S|SIDE EFFECTS:  See also Warning section.||
9046|039|S|   Nausea, vomiting, loss of appetite, diarrhea, headache,||
9046|040|S|dizziness, mouth sores, and pain/swelling/redness at the||
9046|041|S|injection site may occur. Nausea and vomiting can be severe. In||
9046|042|S|some cases, drug therapy may be needed to prevent or relieve||
9046|043|S|nausea and vomiting. Not eating before your treatment may help||
9046|044|S|relieve vomiting. Changes in diet such as eating several small||
9046|045|S|meals or limiting activity may help lessen some of these effects.||
9046|046|S|If any of these effects last or get worse, tell your doctor or||
9046|047|S|pharmacist promptly.||
9046|048|S|   Temporary hair loss may occur. Normal hair growth should||
9046|049|S|return after treatment has ended.||
9046|050|S|   Remember that this medication has been prescribed because your||
9046|051|S|doctor has judged that the benefit to you is greater than the||
9046|052|S|risk of side effects. Many people using this medication do not||
9046|053|S|have serious side effects.||
9046|054|S|   Tell your doctor right away if you have any serious side||
9046|055|S|effects, including: signs of liver problems (such as||
9046|056|S|nausea/vomiting that doesn't stop, stomach/abdominal pain, dark||
9046|057|S|urine, yellowing eyes/skin), muscle/bone pain, chest pain,||
9046|058|S|shortness of breath, eye redness/itching/pain, vision problems||
9046|059|S|(including blindness), painful/difficult swallowing, anal sores,||
9046|060|S|signs of kidney problems (such as change in the amount of urine),||
9046|061|S|painful/difficult urination, joint/side/back pain, numbness or||
9046|062|S|tingling of hands/feet, freckling, big toe pain, black/bloody||
9046|063|S|stools, vomit that looks like coffee grounds, mental/mood changes||
9046|064|S|(such as confusion, unusual drowsiness), enlarged abdomen, muscle||
9046|065|S|weakness, loss of coordination, inability to move (paralysis),||
9046|066|S|seizures.||
9046|067|S|   A very serious allergic reaction to this drug is rare.||
9046|068|S|However, get medical help right away if you notice any symptoms||
9046|069|S|of a serious allergic reaction, including: rash, itching/swelling||
9046|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9046|071|S|breathing.||
9046|072|S|   This is not a complete list of possible side effects. If you||
9046|073|S|notice other effects not listed above, contact your doctor or||
9046|074|S|pharmacist.||
9046|075|S|   In the US -||
9046|076|S|   Call your doctor for medical advice about side effects. You||
9046|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9046|078|S|www.fda.gov/medwatch.||
9046|079|S|   In Canada - Call your doctor for medical advice about side||
9046|080|S|effects. You may report side effects to Health Canada at||
9046|081|S|1-866-234-2345.||
9046|082|B|||
9046|083|P|PRECAUTIONS:  Before using cytarabine, tell your doctor or||
9046|084|P|pharmacist if you are allergic to it; or if you have any other||
9046|085|P|allergies. This product may contain inactive ingredients, which||
9046|086|P|can cause allergic reactions or other problems. Talk to your||
9046|087|P|pharmacist for more details.||
9046|088|P|   Before using this medication, tell your doctor or pharmacist||
9046|089|P|your medical history, especially of: decreased bone marrow||
9046|090|P|function/blood cell disorders (such as anemia, leukopenia,||
9046|091|P|thrombocytopenia), liver disease, kidney disease, gout.||
9046|092|P|   Cytarabine can make you more likely to get infections or may||
9046|093|P|make current infections worse. Stay away from anyone who has an||
9046|094|P|infection that may easily spread (such as chickenpox, COVID-19,||
9046|095|P|measles, flu). Talk to your doctor if you have been exposed to an||
9046|096|P|infection or for more details.||
9046|097|P|   Tell your health care professional that you are using||
9046|098|P|cytarabine before having any immunizations/vaccinations. Avoid||
9046|099|P|contact with people who have recently received live vaccines||
9046|100|P|(such as flu vaccine inhaled through the nose).||
9046|101|P|   To lower the chance of getting cut, bruised, or injured, use||
9046|102|P|caution with sharp objects like razors and nail cutters, and||
9046|103|P|avoid activities such as contact sports.||
9046|104|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9046|105|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9046|106|P|machinery, or do anything that needs alertness until you can do||
9046|107|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9046|108|P|are using marijuana (cannabis).||
9046|109|P|   Before having surgery, tell your doctor or dentist about all||
9046|110|P|the products you use (including prescription drugs,||
9046|111|P|nonprescription drugs, and herbal products).||
9046|112|P|   Tell your doctor if you are pregnant or plan to become||
9046|113|P|pregnant. You should not become pregnant while using cytarabine.||
9046|114|P|Cytarabine may harm an unborn baby, especially in the first 3||
9046|115|P|months of pregnancy. Ask about reliable forms of birth control||
9046|116|P|while using this medication. If you become pregnant, talk to your||
9046|117|P|doctor right away about the risks and benefits of this||
9046|118|P|medication.||
9046|119|P|   It is unknown if this drug passes into breast milk. Because of||
9046|120|P|the possible risk to the infant, breastfeeding is not recommended||
9046|121|P|while using this drug. Consult your doctor before breastfeeding.||
9046|122|B|||
9046|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9046|124|I|medications work or increase your risk for serious side effects.||
9046|125|I|This document does not contain all possible drug interactions.||
9046|126|I|Keep a list of all the products you use (including||
9046|127|I|prescription/nonprescription drugs and herbal products) and share||
9046|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
9046|129|I|the dosage of any medicines without your doctor's approval.||
9046|130|I|   Some products that may interact with this drug include:||
9046|131|I|digoxin, flucytosine, gentamicin.||
9046|132|B|||
9046|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9046|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9046|135|O|poison control center right away. US residents can call||
9046|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9046|137|O|Symptoms of overdose may include confusion, mental/mood changes.||
9046|138|B|||
9046|139|N|NOTES:  Lab and/or medical tests (such as complete blood counts,||
9046|140|N|liver/kidney function, uric acid levels) should be done while you||
9046|141|N|are using this medication. Keep all medical and lab appointments.||
9046|142|N|Consult your doctor for more details.||
9046|143|B|||
9046|144|D|MISSED DOSE:  It is important to get each dose of this medication||
9046|145|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9046|146|D|right away for a new dosing schedule.||
9046|147|B|||
9046|148|R|STORAGE:  Consult the product instructions and your pharmacist||
9046|149|R|for storage details. Keep all medications away from children and||
9046|150|R|pets.||
9046|151|R|   Do not flush medications down the toilet or pour them into a||
9046|152|R|drain unless instructed to do so. Properly discard this product||
9046|153|R|when it is expired or no longer needed. Consult your pharmacist||
9046|154|R|or local waste disposal company.||
9046|155|B|||
9046|156|M|MEDICAL ALERT:  Your condition can cause complications in a||
9046|157|M|medical emergency. For information about enrolling in MedicAlert,||
9046|158|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9046|159|B|||
9046|160|A|Information last revised May 2024.||
9046|161|A|Copyright(c) 2025 First Databank, Inc.||
9046|162|B|||
9047|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9047|002|Z|does NOT have all possible information about this product. This||
9047|003|Z|information does not assure that this product is safe, effective,||
9047|004|Z|or appropriate for you. This information is not individual||
9047|005|Z|medical advice and does not substitute for the advice of your||
9047|006|Z|health care professional. Always ask your health care||
9047|007|Z|professional for complete information about this product and your||
9047|008|Z|specific health needs.||
9047|009|B|||
9047|010|T|PERPHENAZINE/AMITRIPTYLINE - ORAL||
9047|011|F|(per-FEN-a-zeen/A-mi-TRIP-ti-leen)||
9047|012|B|||
9047|013|C|COMMON BRAND NAME(S): Etrafon, Triavil||
9047|014|B|||
9047|015|W|WARNING:  Antidepressant medications are used to treat a variety||
9047|016|W|of conditions, including depression and other mental/mood||
9047|017|W|disorders. These medications can help prevent suicidal||
9047|018|W|thoughts/attempts and provide other important benefits. However,||
9047|019|W|studies have shown that a small number of people (especially||
9047|020|W|people younger than 25) who take antidepressants for any||
9047|021|W|condition may experience worsening depression, other mental/mood||
9047|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
9047|023|W|talk with the doctor about the risks and benefits of||
9047|024|W|antidepressant medication (especially for people younger than||
9047|025|W|25), even if treatment is not for a mental/mood condition. Tell||
9047|026|W|the doctor right away if you notice worsening depression/other||
9047|027|W|psychiatric conditions, unusual behavior changes (including||
9047|028|W|possible suicidal thoughts/attempts), or other mental/mood||
9047|029|W|changes (including new/worsening anxiety, panic attacks, trouble||
9047|030|W|sleeping, irritability, hostile/angry feelings, impulsive||
9047|031|W|actions, severe restlessness, very rapid speech). Be especially||
9047|032|W|watchful for these symptoms when a new antidepressant is started||
9047|033|W|or when the dose is changed.||
9047|034|W|   There may be a slightly increased risk of serious, possibly||
9047|035|W|fatal side effects (such as stroke, heart failure, fast/irregular||
9047|036|W|heartbeat, pneumonia) when this medication is used by older||
9047|037|W|adults with dementia. This medication is not approved for the||
9047|038|W|treatment of dementia-related behavior problems. Discuss the||
9047|039|W|risks and benefits of this medication, as well as other effective||
9047|040|W|and possibly safer treatments for dementia-related behavior||
9047|041|W|problems, with the doctor.||
9047|042|B|||
9047|043|U|USES:  This combination medication is used to treat depression||
9047|044|U|occurring with other mental/mood disorders (such as anxiety,||
9047|045|U|agitation, schizophrenia). Perphenazine belongs to a class of||
9047|046|U|drugs known as antipsychotics. Amitriptyline belongs to a class||
9047|047|U|of drugs known as tricyclic antidepressants.||
9047|048|U|Perphenazine/amitriptyline works by helping to restore the||
9047|049|U|balance of certain natural substances in the brain.||
9047|050|B|||
9047|051|H|HOW TO USE:  Read the Medication Guide provided by your||
9047|052|H|pharmacist before you start using this medication and each time||
9047|053|H|you get a refill. If you have any questions, ask your doctor or||
9047|054|H|pharmacist.||
9047|055|H|   Take this medication by mouth with or without food as directed||
9047|056|H|by your doctor, usually 1 to 4 times daily. If you take it only||
9047|057|H|once a day, take it at bedtime to help reduce daytime sleepiness.||
9047|058|H|   The dosage is based on your medical condition and response to||
9047|059|H|treatment. Your doctor may direct you to take a low dose at||
9047|060|H|first, gradually increasing the dose to lower the chance of side||
9047|061|H|effects (such as drowsiness, dry mouth, muscle spasms). Follow||
9047|062|H|your doctor's directions carefully.||
9047|063|H|   Take this medication regularly to get the most benefit from||
9047|064|H|it. To help you remember, take it at the same time(s) each day.||
9047|065|H|Do not increase your dose or take this drug more often or for||
9047|066|H|longer than prescribed. Your condition will not improve any||
9047|067|H|faster, and your risk of side effects will increase.||
9047|068|H|   Do not stop taking this medication without consulting your||
9047|069|H|doctor. Your condition may become worse when the drug is suddenly||
9047|070|H|stopped. Muscle aches, headaches, and trouble sleeping may also||
9047|071|H|occur. To prevent these symptoms while you are stopping treatment||
9047|072|H|with this drug, your doctor may reduce your dose gradually.||
9047|073|H|Consult your doctor or pharmacist for more details. Report any||
9047|074|H|new or worsening symptoms right away.||
9047|075|H|   This medication may not work right away. You may see some||
9047|076|H|benefit within a week. However, it may take up to 4 weeks before||
9047|077|H|you see the full effect. Tell your doctor if your condition lasts||
9047|078|H|or gets worse (such as increased anxiety, your feelings of||
9047|079|H|sadness get worse, or you have thoughts of suicide).||
9047|080|B|||
9047|081|S|SIDE EFFECTS:  See also Warning section.||
9047|082|S|   Drowsiness, dizziness, lightheadedness, dry mouth, blurred||
9047|083|S|vision, constipation, tiredness, weight gain, or trouble||
9047|084|S|urinating may occur. If any of these effects last or get worse,||
9047|085|S|tell your doctor or pharmacist promptly.||
9047|086|S|   Dizziness and lightheadedness can increase the risk of||
9047|087|S|falling. Get up slowly when rising from a sitting or lying||
9047|088|S|position.||
9047|089|S|   To relieve dry mouth, suck on hard candy or ice chips, chew||
9047|090|S|gum, drink water, or use a saliva substitute.||
9047|091|S|   Tell your doctor right away if any of these side effects||
9047|092|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
9047|093|S|mask-like expression of the face, drooling/trouble swallowing, or||
9047|094|S|shuffling walk. Your doctor may prescribe another medication to||
9047|095|S|decrease these side effects.||
9047|096|S|   Remember that this medication has been prescribed because your||
9047|097|S|doctor has judged that the benefit to you is greater than the||
9047|098|S|risk of side effects. Many people using this medication do not||
9047|099|S|have serious side effects.||
9047|100|S|   Tell your doctor right away if you have any serious side||
9047|101|S|effects, including: nausea/vomiting that doesn't stop, heartburn||
9047|102|S|that doesn't go away, easy bleeding/bruising, signs of infection||
9047|103|S|(such as sore throat that doesn't go away, fever, chills),||
9047|104|S|stomach/abdominal pain, yellowing eyes/skin.||
9047|105|S|   Perphenazine may cause a condition known as tardive||
9047|106|S|dyskinesia. In some cases, this condition may be permanent. Tell||
9047|107|S|your doctor right away if you develop any uncontrollable||
9047|108|S|movements such as lip smacking, mouth puckering, tongue||
9047|109|S|thrusting, chewing, or unusual arm/leg movements.||
9047|110|S|   In rare cases, perphenazine may increase your level of a||
9047|111|S|certain substance made by the body (prolactin). For females, this||
9047|112|S|increase in prolactin may result in unwanted breast milk,||
9047|113|S|missed/stopped periods, or difficulty becoming pregnant. For||
9047|114|S|males, it may result in decreased sexual ability, inability to||
9047|115|S|produce sperm, or enlarged breasts. If you develop any of these||
9047|116|S|symptoms, tell your doctor right away.||
9047|117|S|   This medication may rarely cause a very serious condition||
9047|118|S|called neuroleptic malignant syndrome (NMS). Get medical help||
9047|119|S|right away if you have any of the following symptoms: fever,||
9047|120|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
9047|121|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
9047|122|S|signs of kidney problems (such as change in the amount of urine).||
9047|123|S|   Get medical help right away if you have any very serious side||
9047|124|S|effects, including: signs of stroke (such as weakness on one side||
9047|125|S|of the body, trouble speaking, confusion), eye||
9047|126|S|pain/swelling/redness, widened pupils, vision changes (such as||
9047|127|S|seeing rainbows around lights at night), chest/jaw/left arm pain,||
9047|128|S|fainting, black stools, vomit that looks like coffee grounds,||
9047|129|S|seizures.||
9047|130|S|   This medication may increase serotonin and rarely cause a very||
9047|131|S|serious condition called serotonin syndrome/toxicity. The risk||
9047|132|S|increases if you are also taking other drugs that increase||
9047|133|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
9047|134|S|take (see Drug Interactions section). Get medical help right away||
9047|135|S|if you develop some of the following symptoms: fast heartbeat,||
9047|136|S|hallucinations, loss of coordination, severe dizziness, severe||
9047|137|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
9047|138|S|unusual agitation/restlessness.||
9047|139|S|   A very serious allergic reaction to this drug is rare.||
9047|140|S|However, get medical help right away if you notice any symptoms||
9047|141|S|of a serious allergic reaction, including: rash, itching/swelling||
9047|142|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9047|143|S|breathing.||
9047|144|S|   This is not a complete list of possible side effects. If you||
9047|145|S|notice other effects not listed above, contact your doctor or||
9047|146|S|pharmacist.||
9047|147|S|   In the US -||
9047|148|S|   Call your doctor for medical advice about side effects. You||
9047|149|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9047|150|S|www.fda.gov/medwatch.||
9047|151|S|   In Canada - Call your doctor for medical advice about side||
9047|152|S|effects. You may report side effects to Health Canada at||
9047|153|S|1-866-234-2345.||
9047|154|B|||
9047|155|P|PRECAUTIONS:  See also Warning section.||
9047|156|P|   Before taking amitriptyline with perphenazine, tell your||
9047|157|P|doctor or pharmacist if you are allergic to it; or to other||
9047|158|P|tricyclic antidepressants (such as nortriptyline); or to other||
9047|159|P|phenothiazines (such as chlorpromazine, fluphenazine); or if you||
9047|160|P|have any other allergies. This product may contain inactive||
9047|161|P|ingredients, which can cause allergic reactions or other||
9047|162|P|problems. Talk to your pharmacist for more details.||
9047|163|P|   Before using this medication, tell your doctor or pharmacist||
9047|164|P|your medical history, especially of: bleeding problems, decreased||
9047|165|P|bone marrow function, breathing problems (such as asthma,||
9047|166|P|emphysema), liver problems, low blood pressure, recent heart||
9047|167|P|attack, breast cancer, problems urinating (such as due to||
9047|168|P|enlarged prostate), overactive thyroid (hyperthyroidism),||
9047|169|P|personal or family history of glaucoma (angle-closure type),||
9047|170|P|personal or family history of bipolar disorder, alcohol/substance||
9047|171|P|abuse, family history of suicide, seizures, diabetes, conditions||
9047|172|P|that may increase your risk of seizures (such as head injury,||
9047|173|P|drug/alcohol withdrawal), a certain severe reaction to other||
9047|174|P|medications (neuroleptic malignant syndrome), a certain adrenal||
9047|175|P|gland tumor (pheochromocytoma), restless legs syndrome,||
9047|176|P|Parkinson's disease.||
9047|177|P|   Perphenazine/amitriptyline may cause a condition that affects||
9047|178|P|the heart rhythm (QT prolongation). QT prolongation can rarely||
9047|179|P|cause serious (rarely fatal) fast/irregular heartbeat and other||
9047|180|P|symptoms (such as severe dizziness, fainting) that need medical||
9047|181|P|attention right away.||
9047|182|P|   The risk of QT prolongation may be increased if you have||
9047|183|P|certain medical conditions or are taking other drugs that may||
9047|184|P|cause QT prolongation. Before using perphenazine/amitriptyline,||
9047|185|P|tell your doctor or pharmacist of all the drugs you take and if||
9047|186|P|you have any of the following conditions: certain heart problems||
9047|187|P|(heart failure, slow heartbeat, QT prolongation in the EKG),||
9047|188|P|family history of certain heart problems (QT prolongation in the||
9047|189|P|EKG, sudden cardiac death).||
9047|190|P|   Low levels of potassium or magnesium in the blood may also||
9047|191|P|increase your risk of QT prolongation. This risk may increase if||
9047|192|P|you use certain drugs (such as diuretics/"water pills") or if you||
9047|193|P|have conditions such as severe sweating, diarrhea, vomiting, or||
9047|194|P|eating disorders (such as bulimia). Talk to your doctor about||
9047|195|P|using perphenazine/amitriptyline safely.||
9047|196|P|   This drug may make you dizzy or drowsy or blur your vision.||
9047|197|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9047|198|P|drowsy. Do not drive, use machinery, or do anything that needs||
9047|199|P|alertness or clear vision until you can do it safely. Avoid||
9047|200|P|alcoholic beverages. Talk to your doctor if you are using||
9047|201|P|marijuana (cannabis).||
9047|202|P|   Before having any surgery, procedure, or imaging (such as||
9047|203|P|X-ray, CT-scan), tell your doctor or dentist about this||
9047|204|P|medication and all the products you use (including prescription||
9047|205|P|drugs, nonprescription drugs, and herbal products).||
9047|206|P|   This medication may make you more sensitive to the sun. Limit||
9047|207|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9047|208|P|sunscreen and wear protective clothing when outdoors. Tell your||
9047|209|P|doctor right away if you get sunburned or have skin||
9047|210|P|blisters/redness.||
9047|211|P|   This medication may make you sweat less, making you more||
9047|212|P|likely to get heat stroke. Avoid doing things that may cause you||
9047|213|P|to overheat, such as hard work or exercise in hot weather, or||
9047|214|P|using hot tubs. When the weather is hot, drink a lot of fluids||
9047|215|P|and dress lightly. If you overheat, quickly look for a place to||
9047|216|P|cool down and rest. Get medical help right away if you have a||
9047|217|P|fever that does not go away, mental/mood changes, headache, or||
9047|218|P|dizziness.||
9047|219|P|   Avoid exposure to certain chemicals used in gardening (organic||
9047|220|P|phosphate insecticides). Get medical help right away if you are||
9047|221|P|exposed to garden chemicals and have an unusual headache, heavy||
9047|222|P|sweating, or difficulty breathing.||
9047|223|P|   If you have diabetes, this drug may increase your blood sugar.||
9047|224|P|Check your blood sugar regularly as directed and share the||
9047|225|P|results with your doctor. Tell your doctor right away if you have||
9047|226|P|symptoms such as increased thirst/urination. Your doctor may need||
9047|227|P|to adjust your diabetes medication, exercise program, or diet.||
9047|228|P|   Children may be more sensitive to the side effects of this||
9047|229|P|drug, especially uncontrolled movements.||
9047|230|P|   Older adults may be more sensitive to the side effects of this||
9047|231|P|drug, especially dizziness, lightheadedness, drowsiness,||
9047|232|P|confusion, bleeding, constipation, difficulty urinating,||
9047|233|P|uncontrolled movements, and QT prolongation (see above).||
9047|234|P|Dizziness, lightheadedness, drowsiness, and confusion can||
9047|235|P|increase the risk of falling. Older adults may also be more||
9047|236|P|likely to develop low sodium in the blood, especially if they are||
9047|237|P|taking "water pills" (diuretics).||
9047|238|P|   During pregnancy, this medication should be used only when||
9047|239|P|clearly needed. Babies born to mothers who have used this drug||
9047|240|P|during the last 3 months of pregnancy may rarely develop symptoms||
9047|241|P|including muscle stiffness or shakiness, drowsiness,||
9047|242|P|feeding/breathing difficulties, or constant crying. If you notice||
9047|243|P|any of these symptoms in your newborn especially during their||
9047|244|P|first month, tell the doctor right away.||
9047|245|P|   Since untreated mental/mood problems (such as depression,||
9047|246|P|schizophrenia) can be a serious condition, do not stop taking||
9047|247|P|this medication unless directed by your doctor. If you are||
9047|248|P|planning pregnancy, become pregnant, or think you may be||
9047|249|P|pregnant, immediately discuss with your doctor the benefits and||
9047|250|P|risks of using this medication during pregnancy.||
9047|251|P|   This medication passes into breast milk and may have||
9047|252|P|undesirable effects on a nursing infant. Consult your doctor||
9047|253|P|before breastfeeding.||
9047|254|B|||
9047|255|I|DRUG INTERACTIONS:  See also Precautions section.||
9047|256|I|   Drug interactions may change how your medications work or||
9047|257|I|increase your risk for serious side effects. This document does||
9047|258|I|not contain all possible drug interactions. Keep a list of all||
9047|259|I|the products you use (including prescription/nonprescription||
9047|260|I|drugs and herbal products) and share it with your doctor and||
9047|261|I|pharmacist. Do not start, stop, or change the dosage of any||
9047|262|I|medicines without your doctor's approval.||
9047|263|I|   Some products that may interact with this drug are: certain||
9047|264|I|antihypertensive medications (such as clonidine, guanabenz,||
9047|265|I|methyldopa), other drugs that can cause bleeding/bruising||
9047|266|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
9047|267|I|ibuprofen/naproxen, "blood thinners" such as||
9047|268|I|dabigatran/warfarin), disulfiram, lithium, thyroid supplements.||
9047|269|I|   Taking MAO inhibitors with this medication may cause a serious||
9047|270|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9047|271|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9047|272|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9047|273|I|selegiline, tranylcypromine) during treatment with this||
9047|274|I|medication. Most MAO inhibitors should also not be taken for two||
9047|275|I|weeks before and after treatment with this medication. Ask your||
9047|276|I|doctor when to start or stop taking this medication.||
9047|277|I|   The risk of serotonin syndrome/toxicity increases if you are||
9047|278|I|also taking other drugs that increase serotonin. Examples include||
9047|279|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
9047|280|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
9047|281|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
9047|282|I|serotonin syndrome/toxicity may be more likely when you start or||
9047|283|I|increase the dose of these drugs.||
9047|284|I|   Other medications can affect the removal of||
9047|285|I|perphenazine/amitriptyline from your body, which may affect how||
9047|286|I|this medication works. Examples include cimetidine, azole||
9047|287|I|antifungals (such as ketoconazole, itraconazole), drugs to treat||
9047|288|I|irregular heartbeat (such as amiodarone, flecainide, propafenone,||
9047|289|I|quinidine), macrolide antibiotics (such as erythromycin),||
9047|290|I|rifamycins (such as rifabutin), anti-HIV drugs (such as||
9047|291|I|fosamprenavir), ritonavir, among others.||
9047|292|I|   Tell your doctor or pharmacist if you are taking other||
9047|293|I|products that cause drowsiness such as opioid pain or cough||
9047|294|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9047|295|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9047|296|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9047|297|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
9047|298|I|diphenhydramine).||
9047|299|I|   Many drugs besides perphenazine/amitriptyline may affect the||
9047|300|I|heart rhythm (QT prolongation). Examples include amiodarone,||
9047|301|I|dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide||
9047|302|I|antibiotics (such as erythromycin), among others.||
9047|303|I|   Check the labels on all your medicines (such as allergy or||
9047|304|I|cough-and-cold products) because they may contain ingredients||
9047|305|I|that cause drowsiness. Ask your pharmacist about using those||
9047|306|I|products safely.||
9047|307|I|   Aspirin can increase the risk of bleeding when used with this||
9047|308|I|medication. However, if your doctor has told you to take low-dose||
9047|309|I|aspirin to prevent heart attack or stroke (usually 81-162||
9047|310|I|milligrams a day), you should keep taking the aspirin unless your||
9047|311|I|doctor tells you not to. Ask your doctor or pharmacist for more||
9047|312|I|details.||
9047|313|I|   Amitriptyline is very similar to nortriptyline. Do not use||
9047|314|I|medications containing nortriptyline while using amitriptyline.||
9047|315|B|||
9047|316|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9047|317|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9047|318|O|poison control center right away. US residents can call||
9047|319|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9047|320|O|Symptoms of overdose may include: extreme drowsiness,||
9047|321|O|hallucinations, fast/irregular heartbeat, fainting, slow/shallow||
9047|322|O|breathing, seizures.||
9047|323|B|||
9047|324|N|NOTES:  Do not share this medication with others.||
9047|325|N|   Lab and/or medical tests (such as complete blood count, liver||
9047|326|N|function, EKG) should be done while you are taking this||
9047|327|N|medication. Keep all medical and lab appointments. Consult your||
9047|328|N|doctor for more details.||
9047|329|B|||
9047|330|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9047|331|D|remember. If it is near the time of the next dose, skip the||
9047|332|D|missed dose. Take your next dose at the regular time. Do not||
9047|333|D|double the dose to catch up.||
9047|334|B|||
9047|335|R|STORAGE:  Store at room temperature away from light and moisture.||
9047|336|R|Do not store in the bathroom. Keep all medications away from||
9047|337|R|children and pets.||
9047|338|R|   Do not flush medications down the toilet or pour them into a||
9047|339|R|drain unless instructed to do so. Properly discard this product||
9047|340|R|when it is expired or no longer needed. Consult your pharmacist||
9047|341|R|or local waste disposal company.||
9047|342|B|||
9047|343|A|Information last revised October 2025.||
9047|344|A|Copyright(c) 2025 First Databank, Inc.||
9047|345|B|||
9048|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9048|002|Z|does NOT have all possible information about this product. This||
9048|003|Z|information does not assure that this product is safe, effective,||
9048|004|Z|or appropriate for you. This information is not individual||
9048|005|Z|medical advice and does not substitute for the advice of your||
9048|006|Z|health care professional. Always ask your health care||
9048|007|Z|professional for complete information about this product and your||
9048|008|Z|specific health needs.||
9048|009|B|||
9048|010|T|NITROGLYCERIN OINTMENT - TRANSDERMAL||
9048|011|F|(NYE-troe-GLIS-er-in)||
9048|012|B|||
9048|013|C|COMMON BRAND NAME(S): Nitro-Bid||
9048|014|B|||
9048|015|U|USES:  Nitroglycerin ointment is used to prevent chest pain||
9048|016|U|(angina) in people with a certain heart condition (coronary||
9048|017|U|artery disease). This medication belongs to a class of drugs||
9048|018|U|known as nitrates. Angina occurs when the heart muscle is not||
9048|019|U|getting enough blood. This drug works by relaxing and widening||
9048|020|U|blood vessels so blood can flow more easily to the heart.||
9048|021|U|   This medication will not relieve chest pain once it occurs. It||
9048|022|U|is also not intended to be used just before physical activities||
9048|023|U|(such as exercise, sexual activity) to prevent chest pain. Other||
9048|024|U|medications may be needed in these situations. Consult your||
9048|025|U|doctor for more details.||
9048|026|B|||
9048|027|H|HOW TO USE:  Read the Patient Information Leaflet available from||
9048|028|H|your pharmacist. Consult your doctor or pharmacist if you have||
9048|029|H|any questions.||
9048|030|H|   Apply this medication as directed by your doctor. Avoid||
9048|031|H|touching the ointment with your fingers. Carefully squeeze out||
9048|032|H|your dose onto a paper dose-measuring applicator. These||
9048|033|H|applicators are supplied with the medication. Place the paper||
9048|034|H|applicator with the ointment side down onto a dry, hairless area||
9048|035|H|of skin, usually on the chest. Do not rub the ointment into the||
9048|036|H|skin. Using the paper, lightly spread the ointment to cover an||
9048|037|H|area of a size directed by your doctor. Tape the paper applicator||
9048|038|H|into place and cover with plastic wrap to avoid staining your||
9048|039|H|clothing. Wash your hands after applying and removing the||
9048|040|H|medication.||
9048|041|H|   Remember to use a different area for each application. It is||
9048|042|H|important to apply this medication at the same times each day. Do||
9048|043|H|not change the dosing times unless directed by your doctor. The||
9048|044|H|dosage is based on your medical condition and response to||
9048|045|H|treatment. Remove the medication daily as directed by your||
9048|046|H|doctor.||
9048|047|H|   Use this medication regularly to get the most benefit from it.||
9048|048|H|Do not stop using this medication without consulting your doctor.||
9048|049|H|Some conditions may become worse when the drug is suddenly||
9048|050|H|stopped. Your dose may need to be gradually decreased.||
9048|051|H|   Although unlikely, when this medication is used for a long||
9048|052|H|time, it may not work as well and may require different dosing.||
9048|053|H|Tell your doctor if this medication stops working well (for||
9048|054|H|example, you have worsening chest pain or it occurs more often).||
9048|055|B|||
9048|056|S|SIDE EFFECTS:  Headache, dizziness, lightheadedness, nausea, and||
9048|057|S|flushing may occur. If any of these effects last or get worse,||
9048|058|S|tell your doctor or pharmacist promptly.||
9048|059|S|   Headache is often a sign that this medication is working. Your||
9048|060|S|doctor may recommend treating headaches with an over-the-counter||
9048|061|S|pain reliever (such as acetaminophen, aspirin). If the headaches||
9048|062|S|continue or become severe, tell your doctor promptly.||
9048|063|S|   To reduce the risk of dizziness and lightheadedness, get up||
9048|064|S|slowly when rising from a sitting or lying position.||
9048|065|S|   Remember that this medication has been prescribed because your||
9048|066|S|doctor has judged that the benefit to you is greater than the||
9048|067|S|risk of side effects. Many people using this medication do not||
9048|068|S|have serious side effects.||
9048|069|S|   Tell your doctor right away if you have any serious side||
9048|070|S|effects, including: fainting, fast/irregular/pounding heartbeat.||
9048|071|S|   A very serious allergic reaction to this drug is rare.||
9048|072|S|However, get medical help right away if you notice any symptoms||
9048|073|S|of a serious allergic reaction, including: rash, itching/swelling||
9048|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9048|075|S|breathing.||
9048|076|S|   This is not a complete list of possible side effects. If you||
9048|077|S|notice other effects not listed above, contact your doctor or||
9048|078|S|pharmacist.||
9048|079|S|   In the US -||
9048|080|S|   Call your doctor for medical advice about side effects. You||
9048|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9048|082|S|www.fda.gov/medwatch.||
9048|083|S|   In Canada - Call your doctor for medical advice about side||
9048|084|S|effects. You may report side effects to Health Canada at||
9048|085|S|1-866-234-2345.||
9048|086|B|||
9048|087|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
9048|088|P|pharmacist if you are allergic to it; or to similar drugs (such||
9048|089|P|as isosorbide mononitrate); or to nitrites; or if you have any||
9048|090|P|other allergies. This product may contain inactive ingredients,||
9048|091|P|which can cause allergic reactions or other problems. Talk to||
9048|092|P|your pharmacist for more details.||
9048|093|P|   Before using this medication, tell your doctor or pharmacist||
9048|094|P|your medical history, especially of: recent head injury, anemia,||
9048|095|P|low blood pressure, dehydration, other heart problems (such as||
9048|096|P|recent heart attack).||
9048|097|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9048|098|P|can make you more dizzy. Do not drive, use machinery, or do||
9048|099|P|anything that needs alertness until you can do it safely. Limit||
9048|100|P|alcoholic beverages. Talk to your doctor if you are using||
9048|101|P|marijuana (cannabis).||
9048|102|P|   Before having surgery, tell your doctor or dentist about all||
9048|103|P|the products you use (including prescription drugs,||
9048|104|P|nonprescription drugs, and herbal products).||
9048|105|P|   Older adults may be more sensitive to the side effects of this||
9048|106|P|medication, especially dizziness and lightheadedness which could||
9048|107|P|increase the risk of falls.||
9048|108|P|   During pregnancy, this medication should be used only when||
9048|109|P|clearly needed. Discuss the risks and benefits with your doctor.||
9048|110|P|   It is unknown if this medication passes into breast milk or if||
9048|111|P|it may harm a nursing infant. Consult your doctor before||
9048|112|P|breastfeeding.||
9048|113|B|||
9048|114|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9048|115|I|medications work or increase your risk for serious side effects.||
9048|116|I|This document does not contain all possible drug interactions.||
9048|117|I|Keep a list of all the products you use (including||
9048|118|I|prescription/nonprescription drugs and herbal products) and share||
9048|119|I|it with your doctor and pharmacist. Do not start, stop, or change||
9048|120|I|the dosage of any medicines without your doctor's approval.||
9048|121|I|   Some products that may interact with this drug include: drugs||
9048|122|I|used to treat erectile dysfunction-ED or pulmonary hypertension||
9048|123|I|(such as sildenafil, tadalafil), certain drugs to treat migraine||
9048|124|I|headaches (ergot alkaloids such as ergotamine), riociguat,||
9048|125|I|vericiguat.||
9048|126|I|   This medication may interfere with certain lab tests (such as||
9048|127|I|blood cholesterol levels), possibly causing false test results.||
9048|128|I|Make sure lab personnel and all your doctors know you use this||
9048|129|I|drug.||
9048|130|B|||
9048|131|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9048|132|O|has overdosed and has serious symptoms such as passing out or||
9048|133|O|trouble breathing, call 911. Otherwise, call a poison control||
9048|134|O|center right away. US residents can call 1-800-222-1222. Canada||
9048|135|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9048|136|O|include: slow heartbeat, vision changes, severe nausea/vomiting,||
9048|137|O|sweating, cold/clammy skin, bluish fingers/toes/lips.||
9048|138|B|||
9048|139|N|NOTES:  Do not share this medication with others.||
9048|140|N|   Lab and/or medical tests (such as blood pressure monitoring)||
9048|141|N|should be done while you are using this medication. Keep all||
9048|142|N|medical and lab appointments. Consult your doctor for more||
9048|143|N|details.||
9048|144|N|   Lifestyle changes such as dietary changes, exercise, and||
9048|145|N|stopping smoking may help this drug work better. Talk to your||
9048|146|N|doctor or pharmacist about lifestyle changes that might benefit||
9048|147|N|you.||
9048|148|B|||
9048|149|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
9048|150|D|remember. If it is near the time of the next dose, skip the||
9048|151|D|missed dose. Use your next dose at the regular time. Do not||
9048|152|D|double the dose to catch up.||
9048|153|B|||
9048|154|R|STORAGE:  Store at room temperature. Keep all medications away||
9048|155|R|from children and pets.||
9048|156|R|   Do not flush medications down the toilet or pour them into a||
9048|157|R|drain unless instructed to do so. Properly discard this product||
9048|158|R|when it is expired or no longer needed. Consult your pharmacist||
9048|159|R|or local waste disposal company.||
9048|160|B|||
9048|161|M|MEDICAL ALERT:  Your condition can cause complications in a||
9048|162|M|medical emergency. For information about enrolling in MedicAlert,||
9048|163|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9048|164|B|||
9048|165|A|Information last revised September 2024.||
9048|166|A|Copyright(c) 2025 First Databank, Inc.||
9048|167|B|||
9050|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9050|002|Z|does NOT have all possible information about this product. This||
9050|003|Z|information does not assure that this product is safe, effective,||
9050|004|Z|or appropriate for you. This information is not individual||
9050|005|Z|medical advice and does not substitute for the advice of your||
9050|006|Z|health care professional. Always ask your health care||
9050|007|Z|professional for complete information about this product and your||
9050|008|Z|specific health needs.||
9050|009|B|||
9050|010|T|PENICILLIN G - INJECTION||
9050|011|F|(pen-ih-SILL-in GEE)||
9050|012|B|||
9050|013|C|COMMON BRAND NAME(S): Pfizerpen||
9050|014|B|||
9050|015|U|USES:  This medication is used to treat a wide variety of||
9050|016|U|bacterial infections. It is also used to prevent infection of the||
9050|017|U|heart (bacterial endocarditis) in patients with certain heart||
9050|018|U|diseases who are having surgery. This medication is known as a||
9050|019|U|natural penicillin antibiotic. It works by stopping the growth of||
9050|020|U|bacteria.||
9050|021|B|||
9050|022|H|HOW TO USE:  Depending on your specific product, this medication||
9050|023|H|is given by injection into a vein or into a muscle. Use exactly||
9050|024|H|as directed by your doctor. The dosage is based on your medical||
9050|025|H|condition and response to treatment. Children's dosage is also||
9050|026|H|based on weight.||
9050|027|H|   If you are giving this medication to yourself at home, learn||
9050|028|H|all preparation and usage instructions from your health care||
9050|029|H|professional. Before using, check this product for particles or||
9050|030|H|discoloration. If either is present, do not use the liquid. Learn||
9050|031|H|how to store and discard medical supplies safely.||
9050|032|H|   Give aminoglycosides (such as gentamicin) separately from this||
9050|033|H|medication. Do not mix together in the same IV fluid.||
9050|034|H|   For the best effect, use this antibiotic at evenly spaced||
9050|035|H|times. To help you remember, use this medication at the same||
9050|036|H|time(s) every day.||
9050|037|H|   Continue to use this medication until the full prescribed||
9050|038|H|amount is finished, even if symptoms disappear after a few days.||
9050|039|H|Stopping the medication too early may result in a return of the||
9050|040|H|infection.||
9050|041|H|   Tell your doctor if your condition lasts or gets worse.||
9050|042|B|||
9050|043|S|SIDE EFFECTS:  Pain/redness/swelling at injection site may occur.||
9050|044|S|If any of these effects last or get worse, tell your doctor or||
9050|045|S|pharmacist promptly.||
9050|046|S|   Remember that this medication has been prescribed because your||
9050|047|S|doctor has judged that the benefit to you is greater than the||
9050|048|S|risk of side effects. Many people using this medication do not||
9050|049|S|have serious side effects.||
9050|050|S|   Tell your doctor right away if you have any serious side||
9050|051|S|effects, including: joint/muscle pain, muscle weakness, swelling||
9050|052|S|of ankles/feet, dark/cloudy urine, extreme tiredness,||
9050|053|S|fast/slow/irregular heartbeat, new signs of infection (such as||
9050|054|S|sore throat that doesn't go away, fever, chills), easy||
9050|055|S|bruising/bleeding, signs of kidney problems (such as change in||
9050|056|S|the amount of urine), numbness/tingling of arms/legs, seizures,||
9050|057|S|uncontrolled movements, confusion.||
9050|058|S|   If used to treat syphilis or other spirochetal infections||
9050|059|S|(such as Lyme disease), this medication may cause a condition||
9050|060|S|known as Jarisch-Herxheimer reaction. This condition may occur 1||
9050|061|S|to 2 hours after you receive the medication and can last up to 24||
9050|062|S|hours. Notify your doctor right away if you experience any of||
9050|063|S|these symptoms: fever/chills, muscle pain, worsening of skin||
9050|064|S|sores, fast heartbeat, fast breathing, dizziness, flushing.||
9050|065|S|   This medication may rarely cause a severe intestinal condition||
9050|066|S|due to a bacteria called C. difficile. This condition may occur||
9050|067|S|during treatment or weeks to months after treatment has stopped.||
9050|068|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9050|069|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9050|070|S|stool.||
9050|071|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9050|072|S|products because they may make symptoms worse.||
9050|073|S|   Use of this medication for prolonged or repeated periods may||
9050|074|S|result in oral thrush or a new vaginal yeast infection. Contact||
9050|075|S|your doctor if you notice white patches in your mouth, a change||
9050|076|S|in vaginal discharge, or other new symptoms.||
9050|077|S|   A very serious allergic reaction to this drug is rare.||
9050|078|S|However, get medical help right away if you notice any symptoms||
9050|079|S|of a serious allergic reaction, including: rash, itching/swelling||
9050|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9050|081|S|breathing.||
9050|082|S|   This is not a complete list of possible side effects. If you||
9050|083|S|notice other effects not listed above, contact your doctor or||
9050|084|S|pharmacist.||
9050|085|S|   In the US -||
9050|086|S|   Call your doctor for medical advice about side effects. You||
9050|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9050|088|S|www.fda.gov/medwatch.||
9050|089|S|   In Canada - Call your doctor for medical advice about side||
9050|090|S|effects. You may report side effects to Health Canada at||
9050|091|S|1-866-234-2345.||
9050|092|B|||
9050|093|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
9050|094|P|pharmacist if you are allergic to it; or to penicillin or||
9050|095|P|cephalosporin antibiotics; or if you have any other allergies.||
9050|096|P|This product may contain inactive ingredients (such as corn for||
9050|097|P|products containing dextrose), which can cause allergic reactions||
9050|098|P|or other problems. Talk to your pharmacist for more details.||
9050|099|P|   Before using this medication, tell your doctor or pharmacist||
9050|100|P|your medical history, especially of: asthma, kidney disease.||
9050|101|P|   Penicillin may cause live bacterial vaccines (such as typhoid||
9050|102|P|vaccine) to not work well. Tell your health care professional||
9050|103|P|that you are using penicillin before having any||
9050|104|P|immunizations/vaccinations.||
9050|105|P|   Certain products of this medication contain sodium. Consult||
9050|106|P|your doctor or pharmacist if you are on a salt-restricted diet or||
9050|107|P|if you have a condition that could be worsened by an increase in||
9050|108|P|salt intake (such as heart failure).||
9050|109|P|   Certain products of this medication contain potassium. Consult||
9050|110|P|your doctor or pharmacist if you are taking potassium||
9050|111|P|supplements, salt substitutes containing potassium, or||
9050|112|P|medications that can increase potassium (including ACE inhibitors||
9050|113|P|such as lisinopril), or if you have a high potassium level||
9050|114|P|(hyperkalemia).||
9050|115|P|   Older adults may be at greater risk for side effects while||
9050|116|P|using this drug.||
9050|117|P|   Newborns and infants may be at greater risk for side effects||
9050|118|P|while using this drug.||
9050|119|P|   During pregnancy, this medication should be used only when||
9050|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
9050|121|P|   This drug passes into breast milk. Consult your doctor before||
9050|122|P|breastfeeding.||
9050|123|B|||
9050|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9050|125|I|medications work or increase your risk for serious side effects.||
9050|126|I|This document does not contain all possible drug interactions.||
9050|127|I|Keep a list of all the products you use (including||
9050|128|I|prescription/nonprescription drugs and herbal products) and share||
9050|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
9050|130|I|the dosage of any medicines without your doctor's approval.||
9050|131|I|   A product that may interact with this drug is: methotrexate.||
9050|132|I|   This medication may interfere with certain lab tests (such as||
9050|133|I|certain urine glucose tests), possibly causing false test||
9050|134|I|results. Make sure lab personnel and all your doctors know you||
9050|135|I|use this drug.||
9050|136|B|||
9050|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9050|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9050|139|O|poison control center right away. US residents can call||
9050|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9050|141|O|Symptoms of overdose may include: seizures, confusion,||
9050|142|O|mental/mood changes (such as agitation).||
9050|143|B|||
9050|144|N|NOTES:  Lab and/or medical tests (such as kidney function,||
9050|145|N|complete blood count, potassium/sodium levels) may be done while||
9050|146|N|you are using this medication. Keep all medical and lab||
9050|147|N|appointments. Consult your doctor for more details.||
9050|148|B|||
9050|149|D|MISSED DOSE:  It is important to get each dose of this medication||
9050|150|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9050|151|D|right away for a new dosing schedule. Do not double the dose to||
9050|152|D|catch up.||
9050|153|B|||
9050|154|R|STORAGE:  Consult the product instructions and your pharmacist||
9050|155|R|for storage details. Keep all medications away from children and||
9050|156|R|pets.||
9050|157|R|   Do not flush medications down the toilet or pour them into a||
9050|158|R|drain unless instructed to do so. Properly discard this product||
9050|159|R|when it is expired or no longer needed. Consult your pharmacist||
9050|160|R|or local waste disposal company.||
9050|161|B|||
9050|162|A|Information last revised May 2025.||
9050|163|A|Copyright(c) 2025 First Databank, Inc.||
9050|164|B|||
9051|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9051|002|Z|does NOT have all possible information about this product. This||
9051|003|Z|information does not assure that this product is safe, effective,||
9051|004|Z|or appropriate for you. This information is not individual||
9051|005|Z|medical advice and does not substitute for the advice of your||
9051|006|Z|health care professional. Always ask your health care||
9051|007|Z|professional for complete information about this product and your||
9051|008|Z|specific health needs.||
9051|009|B|||
9051|010|T|SUMATRIPTAN - SUBCUTANEOUS INJECTION||
9051|011|F|(SOO-ma-TRIP-tan)||
9051|012|B|||
9051|013|C|COMMON BRAND NAME(S):  Imitrex, Alsuma||
9051|014|B|||
9051|015|U|USES:  Sumatriptan is used to treat migraines and cluster||
9051|016|U|headaches. It helps to relieve pain and other symptoms of||
9051|017|U|migraines/headaches including sensitivity to light or sound,||
9051|018|U|nausea, and vomiting. Prompt treatment allows you to get back to||
9051|019|U|your normal routine and may decrease your need for other pain||
9051|020|U|medications. It does not prevent future migraines/headaches or||
9051|021|U|reduce how often you may get a headache.||
9051|022|U|   Sumatriptan belongs to a group of drugs called triptans. It||
9051|023|U|affects a certain natural chemical (serotonin) that constricts||
9051|024|U|blood vessels in the brain. It may also block other pain pathways||
9051|025|U|in the brain.||
9051|026|B|||
9051|027|H|HOW TO USE:  Read the Patient Information Leaflet and||
9051|028|H|Instructions for Use if available from your pharmacist before you||
9051|029|H|start using sumatriptan and each time you get a refill. Ask your||
9051|030|H|health care professional how to prepare and use this medication.||
9051|031|H|If you have any questions, ask your doctor or pharmacist.||
9051|032|H|   Inject this medication under the skin as soon as symptoms of||
9051|033|H|your migraine/headache appear. The dosage is based on your||
9051|034|H|medical condition and response to treatment. Before injecting||
9051|035|H|each dose, clean the skin you are going to inject into (the||
9051|036|H|injection site) with rubbing alcohol. This medication should||
9051|037|H|never be injected into a vein or into a muscle. Also, never||
9051|038|H|inject this medication through clothing.||
9051|039|H|   If there is no improvement in your symptoms, do not use any||
9051|040|H|more doses of this medication before talking to your doctor. If||
9051|041|H|your symptoms are only partly relieved, or if your headache comes||
9051|042|H|back, you may use a second injection after one hour or as||
9051|043|H|directed by your doctor. Do not use more than 12 milligrams in a||
9051|044|H|24-hour period.||
9051|045|H|   If your symptoms are only partly relieved or your headache||
9051|046|H|returns, 2 hours after the injection you may switch to||
9051|047|H|sumatriptan taken by mouth instead of using a second injection.||
9051|048|H|After the initial injection you may take sumatriptan by mouth||
9051|049|H|every 2 hours if needed to a maximum of 100 milligrams of tablets||
9051|050|H|in a 24-hour period.||
9051|051|H|   If you have never taken this medication before and you have||
9051|052|H|risk factors for heart disease (see Precautions), you may need to||
9051|053|H|be monitored for rare but serious side effects (such as chest||
9051|054|H|pain) when you use the first dose. Your doctor may ask you to use||
9051|055|H|the first dose in the office.||
9051|056|H|   If you are using drugs for migraine attacks on 10 or more days||
9051|057|H|each month, the drugs may actually make your headaches worse||
9051|058|H|(medication overuse headache). Do not use medications more often||
9051|059|H|or for longer than directed. Tell your doctor if you need to use||
9051|060|H|this medication more often, or if the medication is not working||
9051|061|H|as well, or if your headaches get worse.||
9051|062|B|||
9051|063|S|SIDE EFFECTS:  Pain, swelling, bleeding, or bruising at the||
9051|064|S|injection site may occur. Flushing, sensations of||
9051|065|S|tingling/numbness/prickling/heat, weakness, drowsiness, or||
9051|066|S|dizziness may occur. If any of these effects last or get worse,||
9051|067|S|tell your doctor or pharmacist promptly.||
9051|068|S|   Remember that this medication has been prescribed because your||
9051|069|S|doctor has judged that the benefit to you is greater than the||
9051|070|S|risk of side effects. Many people using this medication do not||
9051|071|S|have serious side effects.||
9051|072|S|   This medication may raise your blood pressure. Check your||
9051|073|S|blood pressure regularly and tell your doctor if the results are||
9051|074|S|high.||
9051|075|S|   Sumatriptan can commonly cause chest/jaw/neck tightness, pain,||
9051|076|S|or pressure that is usually not serious. However, these side||
9051|077|S|effects are like symptoms of a heart attack, which may include||
9051|078|S|chest/jaw/left arm pain, shortness of breath, or unusual||
9051|079|S|sweating. Get medical help right away if these or other serious||
9051|080|S|side effects occur, including: fast/irregular heartbeat,||
9051|081|S|fainting, severe stomach/abdominal pain, bloody diarrhea, signs||
9051|082|S|of a stroke (such as weakness on one side of the body, trouble||
9051|083|S|speaking, sudden vision changes, confusion).||
9051|084|S|   Tell your doctor right away if you have any serious side||
9051|085|S|effects, including: blue fingers/toes/nails, cold sensation of||
9051|086|S|hands/feet, hearing changes, mental/mood changes, seizures.||
9051|087|S|   This medication may increase serotonin and rarely cause a very||
9051|088|S|serious condition called serotonin syndrome/toxicity. The risk||
9051|089|S|increases if you are also taking other drugs that increase||
9051|090|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
9051|091|S|take (see Drug Interactions section). Get medical help right away||
9051|092|S|if you develop some of the following symptoms: fast heartbeat,||
9051|093|S|hallucinations, loss of coordination, severe dizziness, severe||
9051|094|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
9051|095|S|unusual agitation/restlessness.||
9051|096|S|   A very serious allergic reaction to this drug is rare.||
9051|097|S|However, get medical help right away if you notice any symptoms||
9051|098|S|of a serious allergic reaction, including: rash, itching/swelling||
9051|099|S|(especially of the face/tongue/throat), dizziness, trouble||
9051|100|S|breathing.||
9051|101|S|   This is not a complete list of possible side effects. If you||
9051|102|S|notice other effects not listed above, contact your doctor or||
9051|103|S|pharmacist.||
9051|104|S|   In the US -||
9051|105|S|   Call your doctor for medical advice about side effects. You||
9051|106|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9051|107|S|www.fda.gov/medwatch.||
9051|108|S|   In Canada - Call your doctor for medical advice about side||
9051|109|S|effects. You may report side effects to Health Canada at||
9051|110|S|1-866-234-2345.||
9051|111|B|||
9051|112|P|PRECAUTIONS:  Before using sumatriptan, tell your doctor or||
9051|113|P|pharmacist if you are allergic to it; or to other triptan drugs||
9051|114|P|(such as zolmitriptan, rizatriptan); or if you have any other||
9051|115|P|allergies. This product may contain inactive ingredients (such as||
9051|116|P|latex found in some brands), which can cause allergic reactions||
9051|117|P|or other problems. Talk to your pharmacist for more details.||
9051|118|P|   Before using this medication, tell your doctor or pharmacist||
9051|119|P|your medical history, especially of: blood circulation problems||
9051|120|P|(for example, in your legs, arms/hands, or stomach), certain||
9051|121|P|types of headaches (hemiplegic or basilar migraine), heart||
9051|122|P|problems (such as chest pain, irregular heartbeat, previous heart||
9051|123|P|attack), liver disease, seizure, stroke or "mini-stroke"||
9051|124|P|(transient ischemic attack).||
9051|125|P|   Certain conditions can increase your risk for heart problems.||
9051|126|P|Tell your doctor if you have any of these conditions, including:||
9051|127|P|high blood pressure, high cholesterol, diabetes, family history||
9051|128|P|of heart disease, overweight, smoker, postmenopausal (women), age||
9051|129|P|more than 40 years (men).||
9051|130|P|   If you are at high risk for heart disease, your doctor may||
9051|131|P|want to check your heart before prescribing sumatriptan.||
9051|132|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9051|133|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9051|134|P|machinery, or do anything that needs alertness until you can do||
9051|135|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9051|136|P|are using marijuana (cannabis).||
9051|137|P|   Before having surgery, tell your doctor or dentist about all||
9051|138|P|the products you use (including prescription drugs,||
9051|139|P|nonprescription drugs, and herbal products).||
9051|140|P|   The risk of heart disease, liver disease, and high blood||
9051|141|P|pressure increases with age. Older adults may be more sensitive||
9051|142|P|to the side effects of this drug, especially increased blood||
9051|143|P|pressure and heart problems.||
9051|144|P|   During pregnancy, this medication should be used only when||
9051|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
9051|146|P|   This drug passes into breast milk in small amounts. Consult||
9051|147|P|your doctor before breastfeeding.||
9051|148|B|||
9051|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9051|150|I|medications work or increase your risk for serious side effects.||
9051|151|I|This document does not contain all possible drug interactions.||
9051|152|I|Keep a list of all the products you use (including||
9051|153|I|prescription/nonprescription drugs and herbal products) and share||
9051|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
9051|155|I|the dosage of any medicines without your doctor's approval.||
9051|156|I|   Taking MAO inhibitors with this medication may cause a serious||
9051|157|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9051|158|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9051|159|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9051|160|I|selegiline, tranylcypromine) during treatment with this||
9051|161|I|medication. Most MAO inhibitors should also not be taken for two||
9051|162|I|weeks before treatment with this medication. Ask your doctor when||
9051|163|I|to start or stop taking this medication.||
9051|164|I|   The risk of serotonin syndrome/toxicity increases if you are||
9051|165|I|also taking other drugs that increase serotonin. Examples include||
9051|166|I|street drugs such as MDMA/"ecstasy" St. John's wort, certain||
9051|167|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
9051|168|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
9051|169|I|serotonin syndrome/toxicity may be more likely when you start or||
9051|170|I|increase the dose of these drugs.||
9051|171|I|   If you also take any ergotamine medication (such as||
9051|172|I|dihydroergotamine) or any other "triptan" drugs (such as||
9051|173|I|zolmitriptan, rizatriptan), you will need to separate your||
9051|174|I|sumatriptan dose from your dose of these other medications in||
9051|175|I|order to lessen the chance of serious side effects. Ask your||
9051|176|I|doctor how long you should wait between your doses of these||
9051|177|I|drugs.||
9051|178|B|||
9051|179|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9051|180|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9051|181|O|poison control center right away. US residents can call||
9051|182|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9051|183|B|||
9051|184|N|NOTES:  Do not share this medication with others.||
9051|185|N|   Certain foods/beverages or food additives (such as red wine,||
9051|186|N|cheese, chocolate, monosodium glutamate) as well as some||
9051|187|N|lifestyle patterns (such as irregular eating/sleeping habits,||
9051|188|N|stress) may bring about a migraine headache. Avoiding these||
9051|189|N|"triggers" may help decrease the frequency of migraine headaches.||
9051|190|N|Consult your doctor for more details.||
9051|191|N|   Lab and/or medical tests (such as blood pressure) may be done||
9051|192|N|while you are using this medication. Keep all medical and lab||
9051|193|N|appointments. Consult your doctor for more details.||
9051|194|B|||
9051|195|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
9051|196|B|||
9051|197|R|STORAGE:  Different brands of this medication have different||
9051|198|R|storage needs. Check the product package for instructions on how||
9051|199|R|to store your brand, or ask your pharmacist. Keep all medications||
9051|200|R|away from children and pets.||
9051|201|R|   Do not flush medications down the toilet or pour them into a||
9051|202|R|drain unless instructed to do so. Properly discard this product||
9051|203|R|when it is expired or no longer needed. Consult your pharmacist||
9051|204|R|or local waste disposal company.||
9051|205|B|||
9051|206|A|Information last revised December 2024.||
9051|207|A|Copyright(c) 2025 First Databank, Inc.||
9051|208|B|||
9052|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9052|002|Z|does NOT have all possible information about this product. This||
9052|003|Z|information does not assure that this product is safe, effective,||
9052|004|Z|or appropriate for you. This information is not individual||
9052|005|Z|medical advice and does not substitute for the advice of your||
9052|006|Z|health care professional. Always ask your health care||
9052|007|Z|professional for complete information about this product and your||
9052|008|Z|specific health needs.||
9052|009|B|||
9052|010|T|CLOTRIMAZOLE - VAGINAL||
9052|011|F|(kloe-TRIM-a-zole)||
9052|012|B|||
9052|013|C|COMMON BRAND NAME(S): Femcare, Gyne-Lotrimin, Mycelex||
9052|014|B|||
9052|015|U|USES:  This medication is used to treat vaginal yeast infections.||
9052|016|U|Clotrimazole reduces vaginal burning, itching, and discharge that||
9052|017|U|may occur with this condition. This medication is an azole||
9052|018|U|antifungal. It works by stopping the growth of yeast (fungus)||
9052|019|U|that causes the infection. The vaginal product comes in 2 forms||
9052|020|U|(a vaginal cream or tablet). Some products come with a skin cream||
9052|021|U|to be applied to the area around the outside of the vagina.||
9052|022|U|   Ask your doctor before using this medication for||
9052|023|U|self-treatment if this is your first vaginal infection. This||
9052|024|U|medication only works for vaginal fungal infections. You may have||
9052|025|U|a different type of infection (such as bacterial vaginosis) and||
9052|026|U|may need a different medication.||
9052|027|U|   If you have fever, chills, flu-like symptoms,||
9052|028|U|stomach/abdominal pain, or a bad-smelling vaginal discharge, do||
9052|029|U|not use this medication. Contact your doctor right away because||
9052|030|U|these may be signs of a more serious infection.||
9052|031|B|||
9052|032|H|HOW TO USE:  If you are using the over-the-counter product to||
9052|033|H|self-treat, read all directions on the product package before||
9052|034|H|using this medication. If you have any questions, consult your||
9052|035|H|pharmacist. If your doctor has prescribed this medication, use it||
9052|036|H|as directed.||
9052|037|H|   Read the Patient Information Leaflet available with this||
9052|038|H|product. Consult your doctor or pharmacist if you have any||
9052|039|H|questions.||
9052|040|H|   This product is for vaginal use only. Wash your hands before||
9052|041|H|and after use. Avoid contact of this product with your eyes. If||
9052|042|H|it gets into your eyes, wash them right away with plenty of||
9052|043|H|water. Call your doctor if eye irritation lasts.||
9052|044|H|   The dosage is based on your medical condition and response to||
9052|045|H|treatment. Use the medication usually once daily at bedtime for 1||
9052|046|H|to 7 nights depending on the product used, or as directed by your||
9052|047|H|doctor.||
9052|048|H|   If using the vaginal cream, follow the package instructions on||
9052|049|H|how to fill/use the applicator with the cream. Lie on your back||
9052|050|H|with your knees toward your chest. Insert one applicator filled||
9052|051|H|with cream into the vagina as far as it will comfortably go.||
9052|052|H|Slowly press the plunger of the applicator in to apply the cream.||
9052|053|H|Make sure to insert the correct cream for use inside the vagina,||
9052|054|H|not the skin cream for use on the outer genital area (vulva).||
9052|055|H|   If using the vaginal tablet, you may use either the applicator||
9052|056|H|or your finger to insert the tablet. Unwrap the tablet before||
9052|057|H|use. Follow the package instructions on how to fill the||
9052|058|H|applicator with the vaginal tablet. Lie on your back with your||
9052|059|H|knees toward your chest. Insert the tablet or the applicator into||
9052|060|H|the vagina as far as it will comfortably go. Slowly press the||
9052|061|H|plunger of the applicator to release the tablet.||
9052|062|H|   If you have itching/burning around the outside of the vagina||
9052|063|H|(vulva), apply the skin cream to that area usually once or twice||
9052|064|H|a day for no more than 7 days. If you are using a product with||
9052|065|H|only the vaginal cream, you may apply a small amount of the||
9052|066|H|vaginal cream to the area.||
9052|067|H|   Continue to use this medication every day for the full time||
9052|068|H|prescribed, even if symptoms disappear after a few days or if||
9052|069|H|your menstrual period starts. Stopping the medication too soon||
9052|070|H|may allow the yeast infection to return.||
9052|071|H|   Do not use tampons, douches, spermicides or other vaginal||
9052|072|H|products while using this medication. Unscented sanitary napkins||
9052|073|H|may be used for your menstrual period or to protect your clothing||
9052|074|H|from leakage of the medication.||
9052|075|H|   Tell your doctor if your condition does not get better after 3||
9052|076|H|days or lasts more than 7 days, or if your infection returns||
9052|077|H|within 2 months. You may need a different or additional||
9052|078|H|medication to treat your condition.||
9052|079|B|||
9052|080|S|SIDE EFFECTS:  Vaginal/urethral burning/itching/pain, or lower||
9052|081|S|abdominal cramps may occur. If any of these effects last or get||
9052|082|S|worse, tell your doctor or pharmacist promptly.||
9052|083|S|   If your doctor has directed you to use this medication,||
9052|084|S|remember that your doctor has judged that the benefit to you is||
9052|085|S|greater than the risk of side effects. Many people using this||
9052|086|S|medication do not have serious side effects.||
9052|087|S|   A very serious allergic reaction to this drug is rare.||
9052|088|S|However, get medical help right away if you notice any symptoms||
9052|089|S|of a serious allergic reaction, including: rash, itching/swelling||
9052|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9052|091|S|breathing.||
9052|092|S|   This is not a complete list of possible side effects. If you||
9052|093|S|notice other effects not listed above, contact your doctor or||
9052|094|S|pharmacist.||
9052|095|S|   In the US -||
9052|096|S|   Call your doctor for medical advice about side effects. You||
9052|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9052|098|S|www.fda.gov/medwatch.||
9052|099|S|   In Canada - Call your doctor for medical advice about side||
9052|100|S|effects. You may report side effects to Health Canada at||
9052|101|S|1-866-234-2345.||
9052|102|B|||
9052|103|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
9052|104|P|pharmacist if you are allergic to it; or to other azole||
9052|105|P|antifungal agents (such as terconazole, fluconazole); or if you||
9052|106|P|have any other allergies. This product may contain inactive||
9052|107|P|ingredients, which can cause allergic reactions or other||
9052|108|P|problems. Talk to your pharmacist for more details.||
9052|109|P|   If you have any of the following health problems, consult your||
9052|110|P|doctor or pharmacist before using this medication: diabetes,||
9052|111|P|immune system problems (such as HIV-AIDS), frequent vaginal yeast||
9052|112|P|infections (more than 3 in 6 months or 4 in 1 year).||
9052|113|P|   Before having surgery, tell your doctor or dentist about all||
9052|114|P|the products you use (including prescription drugs,||
9052|115|P|nonprescription drugs, and herbal products).||
9052|116|P|   Ask your doctor whether you can have sexual intercourse while||
9052|117|P|using this product. This product may weaken rubber products (such||
9052|118|P|as latex condoms, diaphragms, cervical caps) and lead to failure.||
9052|119|P|This can result in pregnancy. Do not use these products during||
9052|120|P|treatment with this medication. Consult your doctor about other||
9052|121|P|forms of barrier protection/birth control (such as polyurethane||
9052|122|P|condoms) during this time.||
9052|123|P|   Do not use this medication for self-treatment if you are||
9052|124|P|pregnant. During pregnancy, this medication should be used only||
9052|125|P|when clearly needed. If you are pregnant, follow your doctor's||
9052|126|P|instructions on how to use the applicator to insert this||
9052|127|P|medication. Discuss the risks and benefits with your doctor.||
9052|128|P|   It is unknown if this drug passes into breast milk. Consult||
9052|129|P|your doctor before breastfeeding.||
9052|130|B|||
9052|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9052|132|I|medications work or increase your risk for serious side effects.||
9052|133|I|This document does not contain all possible drug interactions.||
9052|134|I|Keep a list of all the products you use (including||
9052|135|I|prescription/nonprescription drugs and herbal products) and share||
9052|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
9052|137|I|the dosage of any medicines without your doctor's approval.||
9052|138|B|||
9052|139|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9052|140|O|has overdosed and has serious symptoms such as passing out or||
9052|141|O|trouble breathing, call 911. Otherwise, call a poison control||
9052|142|O|center right away. US residents can call 1-800-222-1222. Canada||
9052|143|O|residents can call 1-844-764-7669.||
9052|144|B|||
9052|145|N|NOTES:  Do not share this medication with others.||
9052|146|N|   To help prevent vaginal yeast infections, dry the genital area||
9052|147|N|thoroughly after showering, bathing, or swimming. Avoid wearing||
9052|148|N|tight jeans, nylon underwear, pantyhose, a wet bathing suit, or||
9052|149|N|damp/sweaty exercise clothes for long periods. Wear cotton||
9052|150|N|underwear, and change your underwear daily.||
9052|151|N|   If your sexual partner experiences symptoms, they should||
9052|152|N|contact their doctor right away.||
9052|153|B|||
9052|154|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9052|155|D|If it is near the time of the next dose, skip the missed dose.||
9052|156|D|Use your next dose at the regular time. Do not double the dose to||
9052|157|D|catch up.||
9052|158|B|||
9052|159|R|STORAGE:  Store at room temperature. Keep all medications away||
9052|160|R|from children and pets.||
9052|161|R|   Do not flush medications down the toilet or pour them into a||
9052|162|R|drain unless instructed to do so. Properly discard this product||
9052|163|R|when it is expired or no longer needed. Consult your pharmacist||
9052|164|R|or local waste disposal company.||
9052|165|B|||
9052|166|A|Information last revised November 2025.||
9052|167|A|Copyright(c) 2025 First Databank, Inc.||
9052|168|B|||
9053|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9053|002|Z|does NOT have all possible information about this product. This||
9053|003|Z|information does not assure that this product is safe, effective,||
9053|004|Z|or appropriate for you. This information is not individual||
9053|005|Z|medical advice and does not substitute for the advice of your||
9053|006|Z|health care professional. Always ask your health care||
9053|007|Z|professional for complete information about this product and your||
9053|008|Z|specific health needs.||
9053|009|B|||
9053|010|T|PROMETHAZINE - ORAL||
9053|011|F|(proe-METH-a-zeen)||
9053|012|B|||
9053|013|C|COMMON BRAND NAME(S): Phenergan||
9053|014|B|||
9053|015|W|WARNING:  Children may be more sensitive to the side effects of||
9053|016|W|this drug. Promethazine should not be used by children younger||
9053|017|W|than 2 years because it may cause serious (possibly fatal)||
9053|018|W|slow/shallow breathing. Children who are directed to use this||
9053|019|W|medication should be on the lowest effective dose and avoid other||
9053|020|W|drugs that affect breathing. Get medical help right away if||
9053|021|W|slow/shallow breathing occurs.||
9053|022|W|   In children, drugs for nausea should only be used in cases of||
9053|023|W|prolonged vomiting of a known cause. Avoid use of promethazine in||
9053|024|W|children with liver disease (including possible Reye's syndrome).||
9053|025|B|||
9053|026|U|USES:  See also Warning section.||
9053|027|U|   Promethazine is used to prevent and treat nausea and vomiting||
9053|028|U|related to certain conditions (such as before/after surgery,||
9053|029|U|motion sickness). It is also used to treat allergy symptoms such||
9053|030|U|as rash, itching, and runny nose. It may be used to help you feel||
9053|031|U|sleepy/relaxed before and after surgery or to help certain opioid||
9053|032|U|pain relievers (such as meperidine) work better. It may also be||
9053|033|U|used for a short time to treat a runny nose due to the common||
9053|034|U|cold.||
9053|035|U|   Promethazine is an antihistamine and works by blocking a||
9053|036|U|certain natural substance (histamine) that your body makes during||
9053|037|U|an allergic reaction. Its other effects (such as anti-nausea,||
9053|038|U|calming, pain relief) may work by affecting other natural||
9053|039|U|substances (such as acetylcholine) and by acting directly on||
9053|040|U|certain parts of the brain.||
9053|041|U|   Cough-and-cold products have not been shown to be safe or||
9053|042|U|effective in children younger than 6 years. Do not use this||
9053|043|U|product to treat cold symptoms in children younger than 6 years||
9053|044|U|unless specifically directed by the doctor. Some products (such||
9053|045|U|as long-acting tablets/capsules) are not recommended for use in||
9053|046|U|children younger than 12 years. Ask your doctor or pharmacist for||
9053|047|U|more details about using your product safely.||
9053|048|U|   These products do not cure or shorten the length of the common||
9053|049|U|cold and may cause serious side effects. To decrease the risk for||
9053|050|U|serious side effects, carefully follow all dosage directions. Do||
9053|051|U|not give other cough-and-cold medication that might contain the||
9053|052|U|same or similar ingredients (see also Drug Interactions section).||
9053|053|U|Ask the doctor or pharmacist about other ways to relieve cough||
9053|054|U|and cold symptoms (such as drinking enough fluids, using a||
9053|055|U|humidifier or saline nose drops/spray).||
9053|056|B|||
9053|057|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9053|058|H|from your pharmacist before you start taking promethazine and||
9053|059|H|each time you get a refill. If you have any questions, ask your||
9053|060|H|doctor or pharmacist.||
9053|061|H|   Take this medication by mouth with or without food as directed||
9053|062|H|by your doctor, usually 2 to 4 times daily. For motion sickness,||
9053|063|H|the first dose of promethazine should be taken 30 to 60 minutes||
9053|064|H|before beginning travel. For allergies, this medication may be||
9053|065|H|taken once daily at bedtime to avoid being drowsy during the day.||
9053|066|H|When used before surgery, promethazine may be taken the night||
9053|067|H|before or just before the procedure and may be continued||
9053|068|H|afterwards as directed.||
9053|069|H|   If you are using the liquid form of this medication, carefully||
9053|070|H|measure the dose using a special measuring device/spoon. Do not||
9053|071|H|use a household spoon because you may not get the correct dose.||
9053|072|H|   The dosage is based on your age, medical condition, and||
9053|073|H|response to treatment. Children's dosage may also be based on||
9053|074|H|weight. Do not increase your dose or take this medication more||
9053|075|H|often than directed.||
9053|076|H|   Tell your doctor if your condition does not get better or if||
9053|077|H|it gets worse.||
9053|078|B|||
9053|079|S|SIDE EFFECTS:  Drowsiness, dizziness, constipation, blurred||
9053|080|S|vision, or dry mouth may occur. If any of these effects last or||
9053|081|S|get worse, tell your doctor.||
9053|082|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
9053|083|S|chips, chew (sugarless) gum, drink water, or use a saliva||
9053|084|S|substitute.||
9053|085|S|   Remember that this medication has been prescribed because your||
9053|086|S|doctor has judged that the benefit to you is greater than the||
9053|087|S|risk of side effects. Many people using this medication do not||
9053|088|S|have serious side effects.||
9053|089|S|   Tell your doctor right away if you have any serious side||
9053|090|S|effects, including: nausea/vomiting that doesn't stop, fainting,||
9053|091|S|slow heartbeat, mental/mood changes (such as hallucinations,||
9053|092|S|nervousness, irritability, restlessness, confusion),||
9053|093|S|unusual/uncontrolled movements (such as fixed upward stare, neck||
9053|094|S|twisting, tongue movements), shaking (tremor), difficulty||
9053|095|S|urinating, easy bleeding/bruising, signs of infection (such as||
9053|096|S|sore throat that doesn't go away, fever, chills), severe||
9053|097|S|stomach/abdominal pain, yellowing eyes/skin.||
9053|098|S|   Get medical help right away if you have any very serious side||
9053|099|S|effects, including: slow/shallow breathing, seizures.||
9053|100|S|   This medication may rarely cause a very serious condition||
9053|101|S|called neuroleptic malignant syndrome (NMS). Get medical help||
9053|102|S|right away if you have any of the following symptoms: fever,||
9053|103|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
9053|104|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
9053|105|S|signs of kidney problems (such as change in the amount of urine).||
9053|106|S|   A very serious allergic reaction to this drug is rare.||
9053|107|S|However, get medical help right away if you notice any symptoms||
9053|108|S|of a serious allergic reaction, including: rash, itching/swelling||
9053|109|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9053|110|S|breathing.||
9053|111|S|   This is not a complete list of possible side effects. If you||
9053|112|S|notice other effects not listed above, contact your doctor or||
9053|113|S|pharmacist.||
9053|114|S|   In the US -||
9053|115|S|   Call your doctor for medical advice about side effects. You||
9053|116|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9053|117|S|www.fda.gov/medwatch.||
9053|118|S|   In Canada - Call your doctor for medical advice about side||
9053|119|S|effects. You may report side effects to Health Canada at||
9053|120|S|1-866-234-2345.||
9053|121|B|||
9053|122|P|PRECAUTIONS:  See also Warning section.||
9053|123|P|   Before taking promethazine, tell your doctor or pharmacist if||
9053|124|P|you are allergic to it; or to any other phenothiazines (such as||
9053|125|P|prochlorperazine); or if you have any other allergies. This||
9053|126|P|product may contain inactive ingredients, which can cause||
9053|127|P|allergic reactions or other problems. Talk to your pharmacist for||
9053|128|P|more details.||
9053|129|P|   Before using this medication, tell your doctor or pharmacist||
9053|130|P|your medical history, especially of: breathing problems (such as||
9053|131|P|asthma, chronic obstructive pulmonary disease-COPD, sleep apnea),||
9053|132|P|blood/immune system problems (such as bone marrow depression),||
9053|133|P|high pressure in the eye (glaucoma), heart disease (such as||
9053|134|P|irregular heartbeat), high blood pressure, liver disease, certain||
9053|135|P|brain disorders (such as neuroleptic malignant syndrome, Reye's||
9053|136|P|syndrome, seizures), stomach/intestine problems (such as||
9053|137|P|blockage, ulcer), overactive thyroid (hyperthyroidism),||
9053|138|P|difficulty urinating (for example, due to enlarged prostate).||
9053|139|P|   This drug may make you dizzy or drowsy or blur your vision.||
9053|140|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9053|141|P|drowsy. Do not drive, use machinery, or do anything that needs||
9053|142|P|alertness or clear vision until you can do it safely. Avoid||
9053|143|P|alcoholic beverages. Talk to your doctor if you are using||
9053|144|P|marijuana (cannabis).||
9053|145|P|   Before having surgery, tell your doctor or dentist about all||
9053|146|P|the products you use (including prescription drugs,||
9053|147|P|nonprescription drugs, and herbal products).||
9053|148|P|   This medication may make you more sensitive to the sun. Limit||
9053|149|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9053|150|P|sunscreen and wear protective clothing when outdoors. Tell your||
9053|151|P|doctor right away if you get sunburned or have skin||
9053|152|P|blisters/redness.||
9053|153|P|   This medication may make you sweat less, making you more||
9053|154|P|likely to get heat stroke. Avoid doing things that may cause you||
9053|155|P|to overheat, such as hard work or exercise in hot weather, or||
9053|156|P|using hot tubs. When the weather is hot, drink a lot of fluids||
9053|157|P|and dress lightly. If you overheat, quickly look for a place to||
9053|158|P|cool down and rest. Get medical help right away if you have a||
9053|159|P|fever that does not go away, mental/mood changes, headache, or||
9053|160|P|dizziness.||
9053|161|P|   Liquid products may contain sugar and/or alcohol. Caution is||
9053|162|P|advised if you have diabetes, liver disease, or any other||
9053|163|P|condition that requires you to limit/avoid these substances in||
9053|164|P|your diet. Ask your doctor or pharmacist about using this product||
9053|165|P|safely.||
9053|166|P|   Children may be more sensitive to the side effects of this||
9053|167|P|drug, especially slowed breathing and uncontrolled movements (see||
9053|168|P|also Warning section). This drug can often cause excitement in||
9053|169|P|young children instead of drowsiness. Special care should be||
9053|170|P|taken when using this medication in children who have lost a lot||
9053|171|P|of fluid (dehydration), those who have a family history of sudden||
9053|172|P|infant death syndrome (SIDS), and those who are hard to wake up||
9053|173|P|from sleep.||
9053|174|P|   Older adults may be more sensitive to the side effects of this||
9053|175|P|drug, especially drowsiness, confusion, constipation, or trouble||
9053|176|P|urinating. Drowsiness and confusion can increase the risk of||
9053|177|P|falling.||
9053|178|P|   During pregnancy, this medication should be used only when||
9053|179|P|clearly needed. Discuss the risks and benefits with your doctor.||
9053|180|P|   It is unknown if promethazine passes into breast milk. Consult||
9053|181|P|your doctor before breastfeeding.||
9053|182|B|||
9053|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9053|184|I|medications work or increase your risk for serious side effects.||
9053|185|I|This document does not contain all possible drug interactions.||
9053|186|I|Keep a list of all the products you use (including||
9053|187|I|prescription/nonprescription drugs and herbal products) and share||
9053|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
9053|189|I|the dosage of any medicines without your doctor's approval.||
9053|190|I|   Some products that may interact with this drug include:||
9053|191|I|antihistamines applied to the skin (such as diphenhydramine||
9053|192|I|cream, ointment, spray), metoclopramide.||
9053|193|I|   The risk of serious side effects (such as slow/shallow||
9053|194|I|breathing, severe drowsiness/dizziness) may be increased if this||
9053|195|I|medication is taken with other products that may also cause||
9053|196|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
9053|197|I|if you are taking other products such as opioid pain or cough||
9053|198|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9053|199|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9053|200|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9053|201|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
9053|202|I|diphenhydramine).||
9053|203|I|   Check the labels on all your medicines (such as allergy or||
9053|204|I|cough-and-cold products) because they may contain ingredients||
9053|205|I|that cause drowsiness. Ask your pharmacist about using those||
9053|206|I|products safely.||
9053|207|I|   This medication may interfere with certain lab tests (such as||
9053|208|I|some pregnancy tests, glucose tolerance test, allergy skin||
9053|209|I|testing), possibly causing false test results. Make sure lab||
9053|210|I|personnel and all your doctors know you use this drug.||
9053|211|B|||
9053|212|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9053|213|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9053|214|O|poison control center right away. US residents can call||
9053|215|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9053|216|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
9053|217|O|fainting, slow/shallow breathing, seizures, muscle||
9053|218|O|stiffness/twitching, widened pupils. In children, mental/mood||
9053|219|O|changes (such as restlessness, irritability, hallucinations) may||
9053|220|O|occur before drowsiness.||
9053|221|B|||
9053|222|N|NOTES:  Do not share this medication with others.||
9053|223|B|||
9053|224|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9053|225|D|remember. If it is near the time of the next dose, skip the||
9053|226|D|missed dose. Take your next dose at the regular time. Do not||
9053|227|D|double the dose to catch up.||
9053|228|B|||
9053|229|R|STORAGE:  Store at room temperature away from light and moisture.||
9053|230|R|Do not store in the bathroom. Keep all medications away from||
9053|231|R|children and pets.||
9053|232|R|   Do not flush medications down the toilet or pour them into a||
9053|233|R|drain unless instructed to do so. Properly discard this product||
9053|234|R|when it is expired or no longer needed. Consult your pharmacist||
9053|235|R|or local waste disposal company.||
9053|236|B|||
9053|237|A|Information last revised October 2025.||
9053|238|A|Copyright(c) 2025 First Databank, Inc.||
9053|239|B|||
9055|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9055|002|Z|does NOT have all possible information about this product. This||
9055|003|Z|information does not assure that this product is safe, effective,||
9055|004|Z|or appropriate for you. This information is not individual||
9055|005|Z|medical advice and does not substitute for the advice of your||
9055|006|Z|health care professional. Always ask your health care||
9055|007|Z|professional for complete information about this product and your||
9055|008|Z|specific health needs.||
9055|009|B|||
9055|010|T|METRONIDAZOLE - INJECTION||
9055|011|F|(MET-roe-NID-a-zole)||
9055|012|B|||
9055|013|C|COMMON BRAND NAME(S): Flagyl, Metro||
9055|014|B|||
9055|015|U|USES:  Metronidazole is an antibiotic that is used to treat a||
9055|016|U|wide variety of infections. It may also be used to prevent||
9055|017|U|infection after bowel surgery. It works by stopping the growth of||
9055|018|U|certain bacteria and parasites.||
9055|019|B|||
9055|020|H|HOW TO USE:  This medication is given by injection into a vein as||
9055|021|H|directed by your doctor, usually 3 or 4 times a day. It is||
9055|022|H|injected slowly into a vein over 1 hour. The dosage is based on||
9055|023|H|your medical condition and response to treatment.||
9055|024|H|   If you are using this medication at home, learn all||
9055|025|H|preparation and usage instructions from your health care||
9055|026|H|professional. Before using, check this product for particles or||
9055|027|H|discoloration. If either is present, do not use the liquid. Learn||
9055|028|H|how to store and discard medical supplies safely.||
9055|029|H|   For the best effect, use this antibiotic at evenly spaced||
9055|030|H|times. To help you remember, use this medication at the same||
9055|031|H|time(s) every day.||
9055|032|H|   Continue to use this medication for the full time prescribed,||
9055|033|H|even if symptoms disappear after a few days. Stopping the||
9055|034|H|medication too early may result in a return of the infection.||
9055|035|H|   Tell your doctor if your condition lasts or gets worse.||
9055|036|B|||
9055|037|S|SIDE EFFECTS:  Dizziness, headache, stomach upset, nausea,||
9055|038|S|vomiting, loss of appetite, diarrhea, constipation, or metallic||
9055|039|S|taste in your mouth may occur. If any of these effects last or||
9055|040|S|get worse, tell your doctor or pharmacist promptly.||
9055|041|S|   This medication may cause your urine to turn darker in color.||
9055|042|S|This effect is harmless and will disappear when the medication is||
9055|043|S|stopped.||
9055|044|S|   Remember that this medication has been prescribed because your||
9055|045|S|doctor has judged that the benefit to you is greater than the||
9055|046|S|risk of side effects. Many people using this medication do not||
9055|047|S|have serious side effects.||
9055|048|S|   Tell your doctor right away if you have any serious side||
9055|049|S|effects, including: easy bruising/bleeding, stomach/abdominal||
9055|050|S|pain, painful urination.||
9055|051|S|   Get medical help right away if you have any very serious side||
9055|052|S|effects, including: unsteadiness, seizures, mental/mood changes||
9055|053|S|(such as confusion), trouble speaking, numbness/tingling of||
9055|054|S|arms/legs, eye pain, sudden vision changes, headache that is||
9055|055|S|severe or doesn't go away, stiff/painful neck.||
9055|056|S|   Use of this medication for prolonged or repeated periods may||
9055|057|S|result in oral thrush or a new yeast infection. Contact your||
9055|058|S|doctor if you notice white patches in your mouth, a change in||
9055|059|S|vaginal discharge, or other new symptoms.||
9055|060|S|   A very serious allergic reaction to this drug is rare.||
9055|061|S|However, get medical help right away if you notice any symptoms||
9055|062|S|of a serious allergic reaction, including: fever that doesn't go||
9055|063|S|away, new or worsening lymph node swelling, rash,||
9055|064|S|itching/swelling (especially of the face/tongue/throat), severe||
9055|065|S|dizziness, trouble breathing.||
9055|066|S|   This is not a complete list of possible side effects. If you||
9055|067|S|notice other effects not listed above, contact your doctor or||
9055|068|S|pharmacist.||
9055|069|S|   In the US -||
9055|070|S|   Call your doctor for medical advice about side effects. You||
9055|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9055|072|S|www.fda.gov/medwatch.||
9055|073|S|   In Canada - Call your doctor for medical advice about side||
9055|074|S|effects. You may report side effects to Health Canada at||
9055|075|S|1-866-234-2345.||
9055|076|B|||
9055|077|P|PRECAUTIONS:  Before using metronidazole, tell your doctor or||
9055|078|P|pharmacist if you are allergic to it; or to other antibiotics||
9055|079|P|(such as tinidazole); or if you have any other allergies. This||
9055|080|P|product may contain inactive ingredients, which can cause||
9055|081|P|allergic reactions or other problems. Talk to your pharmacist for||
9055|082|P|more details.||
9055|083|P|   Before using this medication, tell your doctor or pharmacist||
9055|084|P|your medical history, especially of: liver disease, kidney||
9055|085|P|disease, certain blood disorders (low blood cell counts),||
9055|086|P|swelling (edema), a certain rare genetic disorder (Cockayne||
9055|087|P|syndrome).||
9055|088|P|   Avoid alcoholic beverages and products containing propylene||
9055|089|P|glycol while taking this medication and for at least 3 days after||
9055|090|P|finishing this medicine because severe stomach upset/cramps,||
9055|091|P|nausea, vomiting, headache, and flushing may occur.||
9055|092|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9055|093|P|can make you more dizzy. Do not drive, use machinery, or do||
9055|094|P|anything that needs alertness until you can do it safely. Talk to||
9055|095|P|your doctor if you are using marijuana (cannabis).||
9055|096|P|   This medication contains sodium. Consult your doctor or||
9055|097|P|pharmacist if you are on a salt-restricted diet or if you have a||
9055|098|P|condition that could be worsened by an increase in salt intake||
9055|099|P|(such as heart failure, edema).||
9055|100|P|   Metronidazole may cause live bacterial vaccines (such as||
9055|101|P|typhoid vaccine) to not work well. Tell your health care||
9055|102|P|professional that you are using metronidazole before having any||
9055|103|P|immunizations/vaccinations.||
9055|104|P|   Before having surgery, tell your doctor or dentist about all||
9055|105|P|the products you use (including prescription drugs,||
9055|106|P|nonprescription drugs, and herbal products).||
9055|107|P|   During pregnancy, this medication should be used only when||
9055|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
9055|109|P|   This medication passes into breast milk. Consult your doctor||
9055|110|P|before breastfeeding.||
9055|111|B|||
9055|112|I|DRUG INTERACTIONS:  See also Precautions section.||
9055|113|I|   Drug interactions may change how your medications work or||
9055|114|I|increase your risk for serious side effects. This document does||
9055|115|I|not contain all possible drug interactions. Keep a list of all||
9055|116|I|the products you use (including prescription/nonprescription||
9055|117|I|drugs and herbal products) and share it with your doctor and||
9055|118|I|pharmacist. Do not start, stop, or change the dosage of any||
9055|119|I|medicines without your doctor's approval.||
9055|120|I|   Some products that may interact with this drug include:||
9055|121|I|alcohol-containing products (such as cough and cold syrups,||
9055|122|I|aftershave), products containing propylene glycol,||
9055|123|I|lopinavir/ritonavir solution, lithium.||
9055|124|I|   Do not use metronidazole if you are also taking disulfiram or||
9055|125|I|if you have taken disulfiram within the last 2 weeks.||
9055|126|I|   This medication may interfere with certain lab tests, possibly||
9055|127|I|causing false test results. Make sure lab personnel and all your||
9055|128|I|doctors know you use this drug.||
9055|129|B|||
9055|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9055|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9055|132|O|poison control center right away. US residents can call||
9055|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9055|134|O|Symptoms of overdose may include: nausea, vomiting, unsteadiness.||
9055|135|B|||
9055|136|N|NOTES:  If you are using this drug for a long time, lab tests||
9055|137|N|(such as blood cell counts) may be done while you are using this||
9055|138|N|medication. Keep all medical and lab appointments. Consult your||
9055|139|N|doctor for more details.||
9055|140|B|||
9055|141|D|MISSED DOSE:  It is important to get each dose of this medication||
9055|142|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9055|143|D|right away for a new dosing schedule. Do not double the dose to||
9055|144|D|catch up.||
9055|145|B|||
9055|146|R|STORAGE:  Consult the product instructions and your pharmacist||
9055|147|R|for storage details. Keep all medications away from children and||
9055|148|R|pets.||
9055|149|R|   Do not flush medications down the toilet or pour them into a||
9055|150|R|drain unless instructed to do so. Properly discard this product||
9055|151|R|when it is expired or no longer needed. Consult your pharmacist||
9055|152|R|or local waste disposal company.||
9055|153|B|||
9055|154|A|Information last revised December 2024.||
9055|155|A|Copyright(c) 2025 First Databank, Inc.||
9055|156|B|||
9056|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9056|002|Z|does NOT have all possible information about this product. This||
9056|003|Z|information does not assure that this product is safe, effective,||
9056|004|Z|or appropriate for you. This information is not individual||
9056|005|Z|medical advice and does not substitute for the advice of your||
9056|006|Z|health care professional. Always ask your health care||
9056|007|Z|professional for complete information about this product and your||
9056|008|Z|specific health needs.||
9056|009|B|||
9056|010|T|METHYLDOPA/HYDROCHLOROTHIAZIDE - ORAL||
9056|011|F|(METH-il-DOE-pa/HYE-droe-KLOR-oh-THYE-a-zide)||
9056|012|B|||
9056|013|C|COMMON BRAND NAME(S): Aldoril||
9056|014|B|||
9056|015|U|USES:  This medication is used to treat high blood pressure||
9056|016|U|(hypertension). Lowering high blood pressure helps prevent||
9056|017|U|strokes, heart attacks, and kidney problems. This product||
9056|018|U|contains 2 medications: methyldopa and hydrochlorothiazide.||
9056|019|U|Methyldopa works by relaxing blood vessels so blood can flow more||
9056|020|U|easily. Hydrochlorothiazide is a "water pill" (diuretic). It||
9056|021|U|increases the amount of urine you make, especially when you first||
9056|022|U|start the medication. It also helps to relax the blood vessels so||
9056|023|U|that blood can flow more easily.||
9056|024|U|   These medications are used together when 1 drug alone is not||
9056|025|U|controlling your blood pressure. Your doctor may direct you to||
9056|026|U|start taking the individual medications first, and then switch||
9056|027|U|you over to this combination product if this is the best dose||
9056|028|U|combination for you.||
9056|029|B|||
9056|030|H|HOW TO USE:  Take this medication by mouth with or without food||
9056|031|H|as directed by your doctor, usually 1 to 3 times daily. It is||
9056|032|H|best to avoid taking this medication within 4 hours of your||
9056|033|H|bedtime to avoid having to get up to urinate. Consult your doctor||
9056|034|H|or pharmacist if you have questions about your dosing schedule.||
9056|035|H|   The dosage is based on your medical condition and response to||
9056|036|H|treatment.||
9056|037|H|   Use this medication regularly in order to get the most benefit||
9056|038|H|from it. To help you remember, take it at the same time(s) each||
9056|039|H|day. Keep taking this medication even if you feel well. Most||
9056|040|H|people with high blood pressure do not feel sick.||
9056|041|H|   If you also take certain drugs to lower your cholesterol (bile||
9056|042|H|acid-binding resins such as cholestyramine or colestipol), take||
9056|043|H|this product at least 4 hours before or at least 4 to 6 hours||
9056|044|H|after these medications.||
9056|045|H|   When this medication is used for a long time, it may not work||
9056|046|H|as well. Talk with your doctor if this medication stops working||
9056|047|H|well (such as your blood pressure readings remain high or||
9056|048|H|increase).||
9056|049|H|   Tell your doctor if your condition does not get better or if||
9056|050|H|it gets worse (your blood pressure readings remain high or||
9056|051|H|increase).||
9056|052|B|||
9056|053|S|SIDE EFFECTS:  Dizziness, lightheadedness, drowsiness, headache,||
9056|054|S|stuffy nose, and weakness may occur as your body adjusts to the||
9056|055|S|medication. If any of these effects last or get worse, tell your||
9056|056|S|doctor or pharmacist promptly.||
9056|057|S|   To reduce the risk of dizziness and lightheadedness, get up||
9056|058|S|slowly when rising from a sitting or lying position.||
9056|059|S|   Remember that this medication has been prescribed because your||
9056|060|S|doctor has judged that the benefit to you is greater than the||
9056|061|S|risk of side effects. Many people using this medication do not||
9056|062|S|have serious side effects.||
9056|063|S|   This medication may cause dehydration and electrolyte||
9056|064|S|imbalance. Tell your doctor right away if you have any symptoms||
9056|065|S|of dehydration or electrolyte imbalance, including unusual dry||
9056|066|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
9056|067|S|heartbeat, or confusion.||
9056|068|S|   Tell your doctor right away if you have any serious side||
9056|069|S|effects, including: fainting, toe/joint pain, signs of kidney||
9056|070|S|problems (such as change in the amount of urine), muscle||
9056|071|S|spasms/uncontrolled muscle movements, missed/stopped periods,||
9056|072|S|decreased sexual desire/ability, increased breast size (in men),||
9056|073|S|mental/mood changes (such as depression), decrease in vision, eye||
9056|074|S|pain, symptoms of heart failure (such as shortness of breath,||
9056|075|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
9056|076|S|gain).||
9056|077|S|   Methyldopa has rarely caused very serious (rarely fatal) liver||
9056|078|S|disease or low red blood cell count (anemia). Tell your doctor||
9056|079|S|right away if you develop any symptoms of liver disease or||
9056|080|S|anemia, including: nausea/vomiting that doesn't stop, loss of||
9056|081|S|appetite, unusual tiredness, unexplained fever, dark urine,||
9056|082|S|severe stomach/abdominal pain, yellowing skin/eyes.||
9056|083|S|   A very serious allergic reaction to this drug is rare.||
9056|084|S|However, get medical help right away if you notice any symptoms||
9056|085|S|of a serious allergic reaction, including: rash, itching/swelling||
9056|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9056|087|S|breathing.||
9056|088|S|   This is not a complete list of possible side effects. If you||
9056|089|S|notice other effects not listed above, contact your doctor or||
9056|090|S|pharmacist.||
9056|091|S|   In the US -||
9056|092|S|   Call your doctor for medical advice about side effects. You||
9056|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9056|094|S|www.fda.gov/medwatch.||
9056|095|S|   In Canada - Call your doctor for medical advice about side||
9056|096|S|effects. You may report side effects to Health Canada at||
9056|097|S|1-866-234-2345.||
9056|098|B|||
9056|099|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
9056|100|P|pharmacist if you are allergic to methyldopa or||
9056|101|P|hydrochlorothiazide; or if you have any other allergies. This||
9056|102|P|product may contain inactive ingredients, which can cause||
9056|103|P|allergic reactions or other problems. Talk to your pharmacist for||
9056|104|P|more details.||
9056|105|P|   Before using this medication, tell your doctor or pharmacist||
9056|106|P|your medical history, especially of: kidney disease, liver||
9056|107|P|disease, heart failure, gout, lupus, untreated mineral imbalance||
9056|108|P|(such as low potassium), a certain adrenal gland tumor||
9056|109|P|(pheochromocytoma), low red blood count (anemia), a certain||
9056|110|P|genetic condition (glucose-6-phosphate dehydrogenase deficiency),||
9056|111|P|skin cancer.||
9056|112|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9056|113|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9056|114|P|machinery, or do anything that needs alertness until you can do||
9056|115|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9056|116|P|are using marijuana (cannabis).||
9056|117|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
9056|118|P|and cause you to feel lightheaded. Tell your doctor if you have||
9056|119|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
9056|120|P|of fluids unless your doctor tells you not to.||
9056|121|P|   Before having surgery, tell your doctor or dentist about all||
9056|122|P|the products you use (including prescription drugs,||
9056|123|P|nonprescription drugs, and herbal products).||
9056|124|P|   If you have diabetes, this product may affect your blood||
9056|125|P|sugar. Check your blood sugar regularly as directed and share the||
9056|126|P|results with your doctor. Tell your doctor right away if you have||
9056|127|P|symptoms of high blood sugar such as increased thirst/urination.||
9056|128|P|Your doctor may need to adjust your diabetes medication, exercise||
9056|129|P|program, or diet.||
9056|130|P|   This medication may reduce the potassium levels in your blood.||
9056|131|P|Ask your doctor about adding potassium to your diet. A potassium||
9056|132|P|supplement may be prescribed by your doctor.||
9056|133|P|   This medication may make you more sensitive to the sun. It may||
9056|134|P|also increase your risk for skin cancer, especially if you take||
9056|135|P|it for a long time. Limit your time in the sun. Avoid tanning||
9056|136|P|booths and sunlamps. Use sunscreen and wear protective clothing||
9056|137|P|when outdoors. Tell your doctor right away if you get sunburned,||
9056|138|P|have skin blisters/redness, or notice new or changed moles/skin||
9056|139|P|lesions.||
9056|140|P|   Older adults may be more sensitive to the side effects of this||
9056|141|P|medication, especially dizziness (more likely when standing up),||
9056|142|P|fainting, or depression. Dizziness and fainting can increase the||
9056|143|P|risk of falling.||
9056|144|P|   During pregnancy, this medication should be used only when||
9056|145|P|clearly needed. Discuss the risks and benefits with your doctor.||
9056|146|P|   This medication passes into breast milk but is unlikely to||
9056|147|P|harm a nursing infant. Consult your doctor before breastfeeding.||
9056|148|B|||
9056|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9056|150|I|medications work or increase your risk for serious side effects.||
9056|151|I|This document does not contain all possible drug interactions.||
9056|152|I|Keep a list of all the products you use (including||
9056|153|I|prescription/nonprescription drugs and herbal products) and share||
9056|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
9056|155|I|the dosage of any medicines without your doctor's approval.||
9056|156|I|   Some products that may interact with this drug include:||
9056|157|I|dofetilide, iron products (such as ferrous sulfate, ferrous||
9056|158|I|gluconate), lithium.||
9056|159|I|   Taking MAO inhibitors with this medication may cause a serious||
9056|160|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9056|161|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9056|162|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9056|163|I|selegiline, tranylcypromine) during treatment with this||
9056|164|I|medication. Most MAO inhibitors should also not be taken for two||
9056|165|I|weeks before treatment with this medication. Ask your doctor when||
9056|166|I|to start or stop taking this medication.||
9056|167|I|   Tell your doctor or pharmacist if you are taking other||
9056|168|I|products that cause drowsiness including alcohol, marijuana||
9056|169|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
9056|170|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
9056|171|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
9056|172|I|codeine).||
9056|173|I|   Check the labels on all your medicines (such as allergy or||
9056|174|I|cough-and-cold products) because they may contain ingredients||
9056|175|I|that cause drowsiness. Ask your pharmacist about using those||
9056|176|I|products safely.||
9056|177|I|   Some products have ingredients that could raise your blood||
9056|178|I|pressure. Tell your pharmacist what products you are using, and||
9056|179|I|ask how to use them safely (especially cough-and-cold products,||
9056|180|I|diet aids, or NSAIDs such as ibuprofen/naproxen).||
9056|181|I|   This medication may interfere with certain lab tests (such as||
9056|182|I|parathyroid test, protein-bound iodide test, urine catecholamine||
9056|183|I|test), possibly causing false test results. Make sure lab||
9056|184|I|personnel and all your doctors know you use this drug.||
9056|185|B|||
9056|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9056|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9056|188|O|poison control center right away. US residents can call||
9056|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9056|190|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
9056|191|O|fainting.||
9056|192|B|||
9056|193|N|NOTES:  Do not share this medication with others.||
9056|194|N|   Lab and/or medical tests (including hematocrit/hemoglobin,||
9056|195|N|complete blood count, Coombs test, kidney/liver function, blood||
9056|196|N|mineral levels such as potassium, skin exams, cholesterol levels)||
9056|197|N|should be done while you are taking this medication. Keep all||
9056|198|N|medical and lab appointments. Consult your doctor for more||
9056|199|N|details.||
9056|200|N|   Lifestyle changes that may help this medication work better||
9056|201|N|include stress reduction programs, exercise, and dietary changes.||
9056|202|N|Talk to your doctor or pharmacist about lifestyle changes that||
9056|203|N|might benefit you.||
9056|204|N|   Have your blood pressure checked regularly while taking this||
9056|205|N|medication. Learn how to monitor your own blood pressure at home,||
9056|206|N|and share the results with your doctor.||
9056|207|B|||
9056|208|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9056|209|D|remember. If it is near the time of the next dose, skip the||
9056|210|D|missed dose. Take your next dose at the regular time. Do not||
9056|211|D|double the dose to catch up.||
9056|212|B|||
9056|213|R|STORAGE:  Store at room temperature away from light and moisture.||
9056|214|R|Do not store in the bathroom. Keep all medications away from||
9056|215|R|children and pets.||
9056|216|R|   Do not flush medications down the toilet or pour them into a||
9056|217|R|drain unless instructed to do so. Properly discard this product||
9056|218|R|when it is expired or no longer needed. Consult your pharmacist||
9056|219|R|or local waste disposal company.||
9056|220|B|||
9056|221|A|Information last revised March 2025.||
9056|222|A|Copyright(c) 2025 First Databank, Inc.||
9056|223|B|||
9061|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9061|002|Z|does NOT have all possible information about this product. This||
9061|003|Z|information does not assure that this product is safe, effective,||
9061|004|Z|or appropriate for you. This information is not individual||
9061|005|Z|medical advice and does not substitute for the advice of your||
9061|006|Z|health care professional. Always ask your health care||
9061|007|Z|professional for complete information about this product and your||
9061|008|Z|specific health needs.||
9061|009|B|||
9061|010|T|GLIPIZIDE - ORAL||
9061|011|F|(GLIP-i-zide)||
9061|012|B|||
9061|013|C|COMMON BRAND NAME(S): Glucotrol||
9061|014|B|||
9061|015|U|USES:  Glipizide is used with a proper diet and exercise program||
9061|016|U|to control high blood sugar in people with type 2 diabetes. It||
9061|017|U|may also be used with other diabetes medications. Controlling||
9061|018|U|high blood sugar helps prevent kidney damage, blindness, nerve||
9061|019|U|problems, loss of limbs, and sexual function problems. Proper||
9061|020|U|control of diabetes may also lessen your risk of a heart attack||
9061|021|U|or stroke. Glipizide belongs to the class of drugs known as||
9061|022|U|sulfonylureas. It lowers blood sugar by causing the release of||
9061|023|U|your body's natural insulin.||
9061|024|B|||
9061|025|H|HOW TO USE:  Take this medication by mouth 30 minutes before||
9061|026|H|breakfast or the first meal of the day as directed by your||
9061|027|H|doctor, usually once daily. Some patients, especially those||
9061|028|H|taking higher doses, may be directed to take this drug twice a||
9061|029|H|day. The dosage is based on your medical condition and response||
9061|030|H|to treatment.||
9061|031|H|   To reduce your risk of side effects, your doctor may direct||
9061|032|H|you to start this medication at a low dose and gradually increase||
9061|033|H|your dose. Follow your doctor's instructions carefully.||
9061|034|H|   Colesevelam can decrease the absorption of glipizide. If you||
9061|035|H|are taking colesevelam, take glipizide at least 4 hours before||
9061|036|H|taking colesevelam.||
9061|037|H|   Use this medication regularly to get the most benefit from it.||
9061|038|H|To help you remember, take it at the same time(s) each day.||
9061|039|H|   Tell your doctor if your condition does not get better or if||
9061|040|H|it gets worse (your blood sugar is too high or too low).||
9061|041|B|||
9061|042|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, diarrhea,||
9061|043|S|constipation, upset stomach, headache, and weight gain may occur.||
9061|044|S|If any of these effects last or get worse, tell your doctor or||
9061|045|S|pharmacist promptly.||
9061|046|S|   Remember that this medication has been prescribed because your||
9061|047|S|doctor has judged that the benefit to you is greater than the||
9061|048|S|risk of side effects. Many people using this medication do not||
9061|049|S|have serious side effects.||
9061|050|S|   Tell your doctor right away if you have any serious side||
9061|051|S|effects, including: signs of infection (such as sore throat that||
9061|052|S|doesn't go away, fever, chills), easy bleeding/bruising, signs of||
9061|053|S|liver disease (such as stomach/abdominal pain, yellowing||
9061|054|S|eyes/skin, dark urine), unusual tiredness/weakness,||
9061|055|S|unusual/sudden weight gain, mental/mood changes, swelling||
9061|056|S|hands/feet, seizures.||
9061|057|S|   This medication can cause low blood sugar (hypoglycemia). This||
9061|058|S|may occur if you do not get enough calories from food or if you||
9061|059|S|do unusually heavy exercise. Symptoms of low blood sugar include||
9061|060|S|sudden sweating, shaking, fast heartbeat, hunger, blurred vision,||
9061|061|S|dizziness, or tingling hands/feet. It is a good habit to carry||
9061|062|S|glucose tablets or gel to treat low blood sugar. If you don't||
9061|063|S|have these reliable forms of glucose, rapidly raise your blood||
9061|064|S|sugar by eating a quick source of sugar such as table sugar,||
9061|065|S|honey, or candy, or drink fruit juice or non-diet soda. Tell your||
9061|066|S|doctor right away about the reaction and the use of this product.||
9061|067|S|To help prevent low blood sugar, eat meals on a regular schedule,||
9061|068|S|and do not skip meals. Check with your doctor or pharmacist to||
9061|069|S|find out what you should do if you miss a meal.||
9061|070|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
9061|071|S|thirst/urination. If these symptoms occur, tell your doctor right||
9061|072|S|away. Your doctor may need to adjust your diabetes medication,||
9061|073|S|exercise program, or diet.||
9061|074|S|   A very serious allergic reaction to this drug is rare.||
9061|075|S|However, get medical help right away if you notice any symptoms||
9061|076|S|of a serious allergic reaction, including: rash, itching/swelling||
9061|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9061|078|S|breathing.||
9061|079|S|   This is not a complete list of possible side effects. If you||
9061|080|S|notice other effects not listed above, contact your doctor or||
9061|081|S|pharmacist.||
9061|082|S|   In the US -||
9061|083|S|   Call your doctor for medical advice about side effects. You||
9061|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9061|085|S|www.fda.gov/medwatch.||
9061|086|S|   In Canada - Call your doctor for medical advice about side||
9061|087|S|effects. You may report side effects to Health Canada at||
9061|088|S|1-866-234-2345.||
9061|089|B|||
9061|090|P|PRECAUTIONS:  Before taking glipizide, tell your doctor or||
9061|091|P|pharmacist if you are allergic to it; or if you have any other||
9061|092|P|allergies. This product may contain inactive ingredients, which||
9061|093|P|can cause allergic reactions or other problems. Talk to your||
9061|094|P|pharmacist for more details.||
9061|095|P|   Before using this medication, tell your doctor or pharmacist||
9061|096|P|your medical history, especially of: liver disease, kidney||
9061|097|P|disease, thyroid disease, certain hormonal conditions||
9061|098|P|(adrenal/pituitary insufficiency, syndrome of inappropriate||
9061|099|P|secretion of antidiuretic hormone-SIADH), electrolyte imbalance||
9061|100|P|(hyponatremia).||
9061|101|P|   You may experience blurred vision, dizziness, or drowsiness||
9061|102|P|due to extremely low or high blood sugar. Do not drive, use||
9061|103|P|machinery, or do anything that needs alertness or clear vision||
9061|104|P|until you can do it safely.||
9061|105|P|   Limit alcohol while taking this medication because it can||
9061|106|P|increase your risk of developing low blood sugar. Alcohol can||
9061|107|P|rarely interact with glipizide and cause a serious reaction||
9061|108|P|(disulfiram-like reaction) with symptoms such as facial flushing,||
9061|109|P|nausea, vomiting, dizziness, or stomach pain. Consult your doctor||
9061|110|P|or pharmacist about the safe use of alcohol.||
9061|111|P|   It may be harder to control your blood sugar when your body is||
9061|112|P|stressed (such as due to fever, infection, injury, or surgery).||
9061|113|P|Consult your doctor because this may require a change in your||
9061|114|P|treatment plan, medications, or blood sugar testing.||
9061|115|P|   This medication may make you more sensitive to the sun. Limit||
9061|116|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9061|117|P|sunscreen and wear protective clothing when outdoors. Tell your||
9061|118|P|doctor right away if you get sunburned or have skin||
9061|119|P|blisters/redness.||
9061|120|P|   Before having surgery, tell your doctor or dentist about all||
9061|121|P|the products you use (including prescription drugs,||
9061|122|P|nonprescription drugs, and herbal products).||
9061|123|P|   Older adults may be more sensitive to the side effects of this||
9061|124|P|drug, especially low blood sugar.||
9061|125|P|   During pregnancy, this medication should be used only when||
9061|126|P|clearly needed. Discuss the risks and benefits with your doctor.||
9061|127|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
9061|128|P|your doctor for managing your blood sugar while pregnant. Your||
9061|129|P|doctor may change your diabetes treatment during your pregnancy||
9061|130|P|(such as diet and medications including insulin).||
9061|131|P|   It is unknown if this medication passes into breast milk.||
9061|132|P|However, similar drugs pass into breast milk. Consult your doctor||
9061|133|P|before breastfeeding.||
9061|134|B|||
9061|135|I|DRUG INTERACTIONS:  See also How to Use section.||
9061|136|I|   Drug interactions may change how your medications work or||
9061|137|I|increase your risk for serious side effects. This document does||
9061|138|I|not contain all possible drug interactions. Keep a list of all||
9061|139|I|the products you use (including prescription/nonprescription||
9061|140|I|drugs and herbal products) and share it with your doctor and||
9061|141|I|pharmacist. Do not start, stop, or change the dosage of any||
9061|142|I|medicines without your doctor's approval.||
9061|143|I|   Many drugs can affect your blood sugar, making it harder to||
9061|144|I|control. Before you start, stop, or change any medication, talk||
9061|145|I|with your doctor or pharmacist about how the medication may||
9061|146|I|affect your blood sugar. Check your blood sugar regularly as||
9061|147|I|directed and share the results with your doctor. Tell your doctor||
9061|148|I|right away if you have symptoms of high or low blood sugar. (See||
9061|149|I|also Side Effects section.) Your doctor may need to adjust your||
9061|150|I|diabetes medication, exercise program, or diet.||
9061|151|I|   Beta-blocker medications (including metoprolol, propranolol,||
9061|152|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
9061|153|I|heartbeat you would usually feel when your blood sugar falls too||
9061|154|I|low (hypoglycemia). Other symptoms of low blood sugar such as||
9061|155|I|dizziness, hunger, or sweating are unaffected by these drugs.||
9061|156|B|||
9061|157|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9061|158|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9061|159|O|poison control center right away. US residents can call||
9061|160|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9061|161|O|Symptoms of overdose may include: shakiness, fast heartbeat,||
9061|162|O|sweating, loss of consciousness.||
9061|163|B|||
9061|164|N|NOTES:  Do not share this medication with others.||
9061|165|N|   Attend a diabetes education program to learn more about how to||
9061|166|N|manage your diabetes with medications, diet, exercise, and||
9061|167|N|regular medical exams.||
9061|168|N|   Learn the symptoms of high and low blood sugar and how to||
9061|169|N|treat low blood sugar. Check your blood sugar regularly as||
9061|170|N|directed.||
9061|171|N|   Lab and/or medical tests (such as liver/kidney function,||
9061|172|N|fasting blood glucose, hemoglobin A1c, complete blood counts)||
9061|173|N|should be done while you are taking this medication. Keep all||
9061|174|N|medical and lab appointments. Consult your doctor for more||
9061|175|N|details.||
9061|176|B|||
9061|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9061|178|D|remember, 30 minutes before a meal. If it is near the time of the||
9061|179|D|next dose, skip the missed dose. Take your next dose at the||
9061|180|D|regular time. Do not double the dose to catch up.||
9061|181|B|||
9061|182|R|STORAGE:  Store at room temperature away from light and moisture.||
9061|183|R|Do not store in the bathroom. Keep all medications away from||
9061|184|R|children and pets.||
9061|185|R|   Do not flush medications down the toilet or pour them into a||
9061|186|R|drain unless instructed to do so. Properly discard this product||
9061|187|R|when it is expired or no longer needed. Consult your pharmacist||
9061|188|R|or local waste disposal company.||
9061|189|B|||
9061|190|M|MEDICAL ALERT:  Your condition can cause complications in a||
9061|191|M|medical emergency. For information about enrolling in MedicAlert,||
9061|192|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9061|193|B|||
9061|194|A|Information last revised November 2025.||
9061|195|A|Copyright(c) 2025 First Databank, Inc.||
9061|196|B|||
9063|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9063|002|Z|does NOT have all possible information about this product. This||
9063|003|Z|information does not assure that this product is safe, effective,||
9063|004|Z|or appropriate for you. This information is not individual||
9063|005|Z|medical advice and does not substitute for the advice of your||
9063|006|Z|health care professional. Always ask your health care||
9063|007|Z|professional for complete information about this product and your||
9063|008|Z|specific health needs.||
9063|009|B|||
9063|010|T|CROTAMITON - TOPICAL||
9063|011|F|(crow-TAM-it-un)||
9063|012|B|||
9063|013|C|COMMON BRAND NAME(S): Eurax||
9063|014|B|||
9063|015|U|USES:  This medication is used to treat scabies. Scabies is a||
9063|016|U|skin infection caused by mites that burrow into the skin.||
9063|017|U|Irritation from the mites leads to severe itching and small||
9063|018|U|bumps/blisters filled with fluid/pus. Crotamiton works by killing||
9063|019|U|the mites that cause scabies. It also helps relieve itching||
9063|020|U|related to scabies and other skin conditions. Crotamiton belongs||
9063|021|U|to two classes of drugs: scabicides and antipruritics.||
9063|022|B|||
9063|023|H|HOW TO USE:  This medication is for use on the skin only. Do not||
9063|024|H|take this medication by mouth. Avoid applying crotamiton on the||
9063|025|H|face, eyes, mouth, vagina, and any skin that is inflamed, raw, or||
9063|026|H|oozing fluid.||
9063|027|H|   If you are using the lotion, shake the bottle thoroughly||
9063|028|H|before use.||
9063|029|H|   To treat scabies, take a bath or shower before using this||
9063|030|H|medication. Remove scaly or crusted skin by rubbing gently. Then||
9063|031|H|dry with a towel. Massage a thin layer of the cream or lotion||
9063|032|H|into all skin from the chin down to the toes, including skin||
9063|033|H|folds/creases, between the fingers and toes, and on the soles of||
9063|034|H|the feet. Trim fingernails short and apply the medication under||
9063|035|H|the nails since the mites often live there. You may use a||
9063|036|H|toothbrush to apply the medication under the fingernails.||
9063|037|H|Immediately after use, wrap the toothbrush in paper and throw it||
9063|038|H|away. Do not use the same toothbrush in the mouth because it may||
9063|039|H|lead to poisoning.||
9063|040|H|   Apply the medication again after 24 hours. Change clothing,||
9063|041|H|towels, and bed sheets the next morning after each application.||
9063|042|H|Wash all clothing, towels, and bedding that have been used in the||
9063|043|H|3 days before treatment and after each application in hot water||
9063|044|H|and dry in a hot dryer (or dry-clean) to kill all the mites and||
9063|045|H|prevent them from returning. Items that cannot be washed or||
9063|046|H|dry-cleaned should be removed from contact with the body for at||
9063|047|H|least 72 hours.||
9063|048|H|   Take a bath 48 hours after the last application to remove the||
9063|049|H|medication from your skin.||
9063|050|H|   To treat other itching skin conditions besides scabies,||
9063|051|H|massage a thin layer gently into the affected areas until the||
9063|052|H|medication is completely absorbed. Repeat as needed, as directed||
9063|053|H|by your doctor, usually 2 to 3 times a day.||
9063|054|H|   After treating scabies, you may still have itching for several||
9063|055|H|weeks. Ask your doctor about other medications that may help to||
9063|056|H|soothe the itching. Tell your doctor if your condition lasts or||
9063|057|H|gets worse.||
9063|058|B|||
9063|059|S|SIDE EFFECTS:  Worsening skin irritation (such as itching,||
9063|060|S|redness) may occur. If any of these effects last or get worse,||
9063|061|S|stop using this medication and tell your doctor or pharmacist||
9063|062|S|promptly.||
9063|063|S|   Remember that this medication has been prescribed because your||
9063|064|S|doctor has judged that the benefit to you is greater than the||
9063|065|S|risk of side effects. Many people using this medication do not||
9063|066|S|have serious side effects.||
9063|067|S|   A very serious allergic reaction to this drug is rare.||
9063|068|S|However, get medical help right away if you notice any symptoms||
9063|069|S|of a serious allergic reaction, including: rash, itching/swelling||
9063|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9063|071|S|breathing.||
9063|072|S|   This is not a complete list of possible side effects. If you||
9063|073|S|notice other effects not listed above, contact your doctor or||
9063|074|S|pharmacist.||
9063|075|S|   In the US -||
9063|076|S|   Call your doctor for medical advice about side effects. You||
9063|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9063|078|S|www.fda.gov/medwatch.||
9063|079|S|   In Canada - Call your doctor for medical advice about side||
9063|080|S|effects. You may report side effects to Health Canada at||
9063|081|S|1-866-234-2345.||
9063|082|B|||
9063|083|P|PRECAUTIONS:  Before using crotamiton, tell your doctor or||
9063|084|P|pharmacist if you are allergic to it; or if you have any other||
9063|085|P|allergies. This product may contain inactive ingredients, which||
9063|086|P|can cause allergic reactions or other problems. Talk to your||
9063|087|P|pharmacist for more details.||
9063|088|P|   Before using this medication, tell your doctor or pharmacist||
9063|089|P|your medical history.||
9063|090|P|   Before having surgery, tell your doctor or dentist about all||
9063|091|P|the products you use (including prescription drugs,||
9063|092|P|nonprescription drugs, and herbal products).||
9063|093|P|   During pregnancy, this medication should be used only when||
9063|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
9063|095|P|   It is unknown if this drug passes into breast milk. Consult||
9063|096|P|your doctor before breastfeeding.||
9063|097|B|||
9063|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9063|099|I|medications work or increase your risk for serious side effects.||
9063|100|I|This document does not contain all possible drug interactions.||
9063|101|I|Keep a list of all the products you use (including||
9063|102|I|prescription/nonprescription drugs and herbal products) and share||
9063|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
9063|104|I|the dosage of any medicines without your doctor's approval.||
9063|105|B|||
9063|106|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9063|107|O|has overdosed and has serious symptoms such as passing out or||
9063|108|O|trouble breathing, call 911. Otherwise, call a poison control||
9063|109|O|center right away. US residents can call 1-800-222-1222. Canada||
9063|110|O|residents can call 1-844-764-7669. If this product is swallowed,||
9063|111|O|symptoms of overdose may include: irritation/burning feeling in||
9063|112|O|the mouth/throat, nausea, vomiting, stomach/abdominal pain.||
9063|113|B|||
9063|114|N|NOTES:  Do not share this medication with others.||
9063|115|N|   If you are being treated for scabies, ask your doctor if||
9063|116|N|people you spent much time with during the previous month (such||
9063|117|N|as household members, sexual partners) should also be checked and||
9063|118|N|treated for scabies.||
9063|119|N|   This medication has been prescribed for your current condition||
9063|120|N|only. Do not use it later for another infection unless your||
9063|121|N|doctor tells you to.||
9063|122|B|||
9063|123|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9063|124|D|If it is near the time of the next dose, skip the missed dose.||
9063|125|D|Use your next dose at the regular time. Do not double the dose to||
9063|126|D|catch up.||
9063|127|B|||
9063|128|R|STORAGE:  Store at room temperature. Keep all medications away||
9063|129|R|from children and pets.||
9063|130|R|   Do not flush medications down the toilet or pour them into a||
9063|131|R|drain unless instructed to do so. Properly discard this product||
9063|132|R|when it is expired or no longer needed. Consult your pharmacist||
9063|133|R|or local waste disposal company.||
9063|134|B|||
9063|135|A|Information last revised May 2024.||
9063|136|A|Copyright(c) 2025 First Databank, Inc.||
9063|137|B|||
9066|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9066|002|Z|does NOT have all possible information about this product. This||
9066|003|Z|information does not assure that this product is safe, effective,||
9066|004|Z|or appropriate for you. This information is not individual||
9066|005|Z|medical advice and does not substitute for the advice of your||
9066|006|Z|health care professional. Always ask your health care||
9066|007|Z|professional for complete information about this product and your||
9066|008|Z|specific health needs.||
9066|009|B|||
9066|010|T|HYDROCHLOROTHIAZIDE - ORAL||
9066|011|F|(HYE-droe-KLOR-oh-THYE-a-zide)||
9066|012|B|||
9066|013|C|COMMON BRAND NAME(S): Hydrodiuril, Inzirqo, Microzide||
9066|014|B|||
9066|015|U|USES:  This medication is used to treat high blood pressure.||
9066|016|U|Lowering high blood pressure helps prevent strokes, heart||
9066|017|U|attacks, and kidney problems. Hydrochlorothiazide belongs to a||
9066|018|U|class of drugs known as diuretics/"water pills." It works by||
9066|019|U|causing you to make more urine. This helps your body get rid of||
9066|020|U|extra salt and water.||
9066|021|U|   This medication also reduces extra fluid in the body (edema)||
9066|022|U|caused by conditions such as heart failure, liver disease, or||
9066|023|U|kidney disease. This can lessen symptoms such as shortness of||
9066|024|U|breath or swelling in your ankles or feet.||
9066|025|B|||
9066|026|H|HOW TO USE:  Take this medication by mouth as directed by your||
9066|027|H|doctor, usually once daily in the morning with or without food.||
9066|028|H|If you take this drug too close to bedtime, you may need to wake||
9066|029|H|up to urinate. It is best to take this medication at least 4||
9066|030|H|hours before your bedtime.||
9066|031|H|   If you are taking the liquid suspension form of this||
9066|032|H|medication, shake the bottle well before each dose. Carefully||
9066|033|H|measure the dose using a special measuring device. Do not use a||
9066|034|H|household spoon because you may not get the correct dose.||
9066|035|H|   The dosage is based on your medical condition and response to||
9066|036|H|treatment. Children's dosage is also based on weight and age.||
9066|037|H|   Use this medication regularly to get the most benefit from it.||
9066|038|H|To help you remember, take it at the same time each day. Keep||
9066|039|H|taking this medication even if you feel well. Most people with||
9066|040|H|high blood pressure do not feel sick.||
9066|041|H|   If you also take certain drugs to lower your cholesterol (bile||
9066|042|H|acid-binding resins such as cholestyramine or colestipol), take||
9066|043|H|hydrochlorothiazide at least 4 hours before or at least 4 to 6||
9066|044|H|hours after these medications.||
9066|045|H|   Tell your doctor if your condition does not get better or if||
9066|046|H|it gets worse (for example, your blood pressure readings remain||
9066|047|H|high or increase).||
9066|048|B|||
9066|049|S|SIDE EFFECTS:  Upset stomach, dizziness, or headache may occur as||
9066|050|S|your body adjusts to the medication. If any of these effects last||
9066|051|S|or get worse, tell your doctor or pharmacist promptly.||
9066|052|S|   To reduce the risk of dizziness and lightheadedness, get up||
9066|053|S|slowly when rising from a sitting or lying position.||
9066|054|S|   Remember that this medication has been prescribed because your||
9066|055|S|doctor has judged that the benefit to you is greater than the||
9066|056|S|risk of side effects. Many people using this medication do not||
9066|057|S|have serious side effects.||
9066|058|S|   This medication may cause dehydration and electrolyte||
9066|059|S|imbalance. Tell your doctor right away if you have any symptoms||
9066|060|S|of dehydration or electrolyte imbalance, including unusual dry||
9066|061|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
9066|062|S|heartbeat, or confusion.||
9066|063|S|   Tell your doctor right away if you have any serious side||
9066|064|S|effects, including: fainting, signs of kidney problems (such as||
9066|065|S|change in the amount of urine), decrease in vision, eye pain.||
9066|066|S|   A very serious allergic reaction to this drug is rare.||
9066|067|S|However, get medical help right away if you notice any symptoms||
9066|068|S|of a serious allergic reaction, including: rash, itching/swelling||
9066|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9066|070|S|breathing.||
9066|071|S|   This is not a complete list of possible side effects. If you||
9066|072|S|notice other effects not listed above, contact your doctor or||
9066|073|S|pharmacist.||
9066|074|S|   In the US -||
9066|075|S|   Call your doctor for medical advice about side effects. You||
9066|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9066|077|S|www.fda.gov/medwatch.||
9066|078|S|   In Canada - Call your doctor for medical advice about side||
9066|079|S|effects. You may report side effects to Health Canada at||
9066|080|S|1-866-234-2345.||
9066|081|B|||
9066|082|P|PRECAUTIONS:  Before taking hydrochlorothiazide, tell your doctor||
9066|083|P|or pharmacist if you are allergic to it; or if you have any other||
9066|084|P|allergies. This product may contain inactive ingredients (such as||
9066|085|P|sulfites found in some brands), which can cause allergic||
9066|086|P|reactions or other problems. Talk to your pharmacist for more||
9066|087|P|details.||
9066|088|P|   Before using this medication, tell your doctor or pharmacist||
9066|089|P|your medical history, especially of: diabetes, gout, kidney||
9066|090|P|disease, liver disease, lupus, skin cancer.||
9066|091|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9066|092|P|can make you more dizzy. Do not drive, use machinery, or do||
9066|093|P|anything that needs alertness until you can do it safely. Limit||
9066|094|P|alcoholic beverages. Talk to your doctor if you are using||
9066|095|P|marijuana (cannabis).||
9066|096|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
9066|097|P|and cause you to feel lightheaded. Tell your doctor if you have||
9066|098|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
9066|099|P|of fluids unless your doctor tells you not to.||
9066|100|P|   If you have diabetes, hydrochlorothiazide may affect your||
9066|101|P|blood sugar. Check your blood sugar regularly as directed by your||
9066|102|P|doctor. Your doctor may need to adjust your diabetes medication,||
9066|103|P|exercise program, or diet.||
9066|104|P|   This drug may decrease your potassium levels. Ask your doctor||
9066|105|P|about foods high in potassium (such as bananas, orange juice) or||
9066|106|P|about using a salt substitute containing potassium. A potassium||
9066|107|P|supplement may be prescribed by your doctor.||
9066|108|P|   This medication may make you more sensitive to the sun. It may||
9066|109|P|also increase your risk for skin cancer, especially if you take||
9066|110|P|it for a long time. Limit your time in the sun. Avoid tanning||
9066|111|P|booths and sunlamps. Use sunscreen and wear protective clothing||
9066|112|P|when outdoors. Tell your doctor right away if you get sunburned,||
9066|113|P|have skin blisters/redness, or notice new or changed moles/skin||
9066|114|P|lesions.||
9066|115|P|   Before having surgery, tell your doctor or dentist about all||
9066|116|P|the products you use (including prescription drugs,||
9066|117|P|nonprescription drugs, and herbal products).||
9066|118|P|   Older adults may be more sensitive to the effects of this||
9066|119|P|drug, especially dizziness.||
9066|120|P|   During pregnancy, this medication should be used only when||
9066|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
9066|122|P|   This drug passes into breast milk, but is unlikely to harm a||
9066|123|P|nursing infant. Consult your doctor before breastfeeding.||
9066|124|B|||
9066|125|I|DRUG INTERACTIONS:  See also How To Use section.||
9066|126|I|   Drug interactions may change how your medications work or||
9066|127|I|increase your risk for serious side effects. This document does||
9066|128|I|not contain all possible drug interactions. Keep a list of all||
9066|129|I|the products you use (including prescription/nonprescription||
9066|130|I|drugs and herbal products) and share it with your doctor and||
9066|131|I|pharmacist. Do not start, stop, or change the dosage of any||
9066|132|I|medicines without your doctor's approval.||
9066|133|I|   Some products that may interact with this drug include:||
9066|134|I|dofetilide, lithium.||
9066|135|I|   Some products have ingredients that could raise your blood||
9066|136|I|pressure or worsen your swelling. Tell your pharmacist what||
9066|137|I|products you are using, and ask how to use them safely||
9066|138|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
9066|139|I|ibuprofen/naproxen).||
9066|140|I|   This medication may interfere with certain lab tests (such as||
9066|141|I|parathyroid function), possibly causing false test results. Make||
9066|142|I|sure lab personnel and all your doctors know you use this drug.||
9066|143|B|||
9066|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9066|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9066|146|O|poison control center right away. US residents can call||
9066|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9066|148|O|Symptoms of overdose may include: severe dizziness, weakness,||
9066|149|O|fainting.||
9066|150|B|||
9066|151|N|NOTES:  Do not share this medication with others.||
9066|152|N|   Lifestyle changes that may help this medication work better||
9066|153|N|include exercising, stopping smoking, and eating a||
9066|154|N|low-cholesterol/low-fat diet. Consult your doctor for more||
9066|155|N|details.||
9066|156|N|   Lab and/or medical tests (such as potassium levels, kidney||
9066|157|N|function, skin exams, cholesterol levels) should be done while||
9066|158|N|you are taking this medication. Keep all medical and lab||
9066|159|N|appointments. Consult your doctor for more details.||
9066|160|N|   Check your blood pressure and pulse (heart rate) regularly||
9066|161|N|while taking this medication. Learn how to check your own blood||
9066|162|N|pressure and pulse at home, and share the results with your||
9066|163|N|doctor.||
9066|164|B|||
9066|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9066|166|D|remember. If it is near the time of the next dose, skip the||
9066|167|D|missed dose. Take your next dose at the regular time. Do not||
9066|168|D|double the dose to catch up.||
9066|169|B|||
9066|170|R|STORAGE:  Store at room temperature away from light and moisture.||
9066|171|R|Do not store in the bathroom. Do not freeze the suspension form||
9066|172|R|of this medication. Discard any unused suspension after 30 days.||
9066|173|R|Keep all medications away from children and pets.||
9066|174|R|   Do not flush medications down the toilet or pour them into a||
9066|175|R|drain unless instructed to do so. Properly discard this product||
9066|176|R|when it is expired or no longer needed. Consult your pharmacist||
9066|177|R|or local waste disposal company.||
9066|178|B|||
9066|179|A|Information last revised March 2025.||
9066|180|A|Copyright(c) 2025 First Databank, Inc.||
9066|181|B|||
9067|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9067|002|Z|does NOT have all possible information about this product. This||
9067|003|Z|information does not assure that this product is safe, effective,||
9067|004|Z|or appropriate for you. This information is not individual||
9067|005|Z|medical advice and does not substitute for the advice of your||
9067|006|Z|health care professional. Always ask your health care||
9067|007|Z|professional for complete information about this product and your||
9067|008|Z|specific health needs.||
9067|009|B|||
9067|010|T|SPIRONOLACTONE/HYDROCHLOROTHIAZIDE - ORAL||
9067|011|F|(SPY-row-no-lack-tone/HYE-droe-KLOR-oh-THYE-a-zide)||
9067|012|B|||
9067|013|C|COMMON BRAND NAME(S): Aldactazide||
9067|014|B|||
9067|015|U|USES:  This product is used to treat high blood pressure||
9067|016|U|(hypertension), heart failure, or extra fluid in the body||
9067|017|U|(edema). Lowering high blood pressure helps prevent strokes,||
9067|018|U|heart attacks, and kidney problems.||
9067|019|U|   This product contains two medications: spironolactone and||
9067|020|U|hydrochlorothiazide. Both medications are "water pills"||
9067|021|U|(diuretics) and cause your body to get rid of extra salt and||
9067|022|U|water. This effect helps to relax the blood vessels so that blood||
9067|023|U|can flow more easily and may increase the amount of urine you||
9067|024|U|make when you first start the product. Spironolactone also helps||
9067|025|U|to treat or prevent low blood potassium levels and block the||
9067|026|U|activity of a certain natural substance (aldosterone) that can||
9067|027|U|cause edema.||
9067|028|U|   Your doctor may direct you to start taking the individual||
9067|029|U|medications first, and then switch you over to this combination||
9067|030|U|product if this is the best dose combination for you.||
9067|031|B|||
9067|032|H|HOW TO USE:  Take this medication by mouth with or without food||
9067|033|H|as directed by your doctor, usually once or twice daily. The||
9067|034|H|dosage is based on your medical condition and response to||
9067|035|H|treatment.||
9067|036|H|   If you take this drug too close to bedtime, you may need to||
9067|037|H|wake up to urinate. It is best to take this medication at least 4||
9067|038|H|hours before your bedtime. If you have any questions about how||
9067|039|H|and when to take this medication, ask your doctor or pharmacist.||
9067|040|H|   Use this medication regularly in order to get the most benefit||
9067|041|H|from it. To help you remember, take it at the same time(s) each||
9067|042|H|day. Keep taking this medication even if you feel well. Most||
9067|043|H|people with high blood pressure do not feel sick.||
9067|044|H|   If you also take certain drugs to lower your cholesterol (bile||
9067|045|H|acid-binding resins such as cholestyramine or colestipol), take||
9067|046|H|this product at least 4 hours before or at least 4 to 6 hours||
9067|047|H|after these medications.||
9067|048|H|   Tell your doctor if your condition does not get better or if||
9067|049|H|it gets worse (for example, your blood pressure readings remain||
9067|050|H|high or increase).||
9067|051|B|||
9067|052|S|SIDE EFFECTS:  Dizziness, drowsiness, lightheadedness, loss of||
9067|053|S|appetite, or diarrhea may occur. If any of these effects last or||
9067|054|S|get worse, tell your doctor or pharmacist promptly.||
9067|055|S|   To reduce the risk of dizziness and lightheadedness, get up||
9067|056|S|slowly when rising from a sitting or lying position.||
9067|057|S|   Remember that this medication has been prescribed because your||
9067|058|S|doctor has judged that the benefit to you is greater than the||
9067|059|S|risk of side effects. Many people using this medication do not||
9067|060|S|have serious side effects.||
9067|061|S|   This product may cause dehydration and electrolyte imbalance.||
9067|062|S|Tell your doctor right away if you have any symptoms of||
9067|063|S|dehydration or electrolyte imbalance, including unusual dry||
9067|064|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
9067|065|S|heartbeat, or confusion.||
9067|066|S|   Tell your doctor right away if you have any serious side||
9067|067|S|effects, including: joint pain, breast pain, breast enlargement||
9067|068|S|in men (gynecomastia), easy bruising/bleeding, fainting, signs of||
9067|069|S|kidney problems (such as change in the amount of urine), signs of||
9067|070|S|liver problems (such as nausea/vomiting that doesn't stop, dark||
9067|071|S|urine, stomach/abdominal pain, yellowing eyes/skin), decrease in||
9067|072|S|vision, eye pain.||
9067|073|S|   A very serious allergic reaction to this drug is rare.||
9067|074|S|However, get medical help right away if you notice any symptoms||
9067|075|S|of a serious allergic reaction, including: rash, itching/swelling||
9067|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9067|077|S|breathing.||
9067|078|S|   This is not a complete list of possible side effects. If you||
9067|079|S|notice other effects not listed above, contact your doctor or||
9067|080|S|pharmacist.||
9067|081|S|   In the US -||
9067|082|S|   Call your doctor for medical advice about side effects. You||
9067|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9067|084|S|www.fda.gov/medwatch.||
9067|085|S|   In Canada - Call your doctor for medical advice about side||
9067|086|S|effects. You may report side effects to Health Canada at||
9067|087|S|1-866-234-2345.||
9067|088|B|||
9067|089|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
9067|090|P|pharmacist if you are allergic to either spironolactone or||
9067|091|P|hydrochlorothiazide; or if you have any other allergies. This||
9067|092|P|product may contain inactive ingredients, which can cause||
9067|093|P|allergic reactions or other problems. Talk to your pharmacist for||
9067|094|P|more details.||
9067|095|P|   Before using this medication, tell your doctor or pharmacist||
9067|096|P|your medical history, especially of: untreated salt/mineral||
9067|097|P|imbalance (such as high potassium, low sodium level), kidney||
9067|098|P|disease, liver disease, diabetes, dehydration, lupus, gout,||
9067|099|P|decreased adrenal gland function (Addison's disease), skin||
9067|100|P|cancer.||
9067|101|P|   Before having surgery, tell your doctor or dentist about all||
9067|102|P|the products you use (including prescription drugs,||
9067|103|P|nonprescription drugs, and herbal products).||
9067|104|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9067|105|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9067|106|P|machinery, or do anything that needs alertness until you can do||
9067|107|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9067|108|P|are using marijuana (cannabis).||
9067|109|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
9067|110|P|and cause you to feel lightheaded. Tell your doctor if you have||
9067|111|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
9067|112|P|of fluids unless your doctor tells you not to.||
9067|113|P|   This medication may make you more sensitive to the sun. It may||
9067|114|P|also increase your risk for skin cancer, especially if you take||
9067|115|P|it for a long time. Limit your time in the sun. Avoid tanning||
9067|116|P|booths and sunlamps. Use sunscreen and wear protective clothing||
9067|117|P|when outdoors. Tell your doctor right away if you get sunburned,||
9067|118|P|have skin blisters/redness, or notice new or changed moles/skin||
9067|119|P|lesions.||
9067|120|P|   If you have diabetes, this product may affect your blood||
9067|121|P|sugar. Check your blood sugar regularly as directed and share the||
9067|122|P|results with your doctor. Tell your doctor right away if you have||
9067|123|P|symptoms of high blood sugar such as increased thirst/urination.||
9067|124|P|Your doctor may need to adjust your diabetes medication, exercise||
9067|125|P|program, or diet.||
9067|126|P|   This product may affect the potassium levels in your blood.||
9067|127|P|Before using potassium supplements or salt substitutes that||
9067|128|P|contain potassium, consult your doctor or pharmacist.||
9067|129|P|   Older adults may be more sensitive to the side effects of this||
9067|130|P|drug, especially the effects on potassium, dizziness, or||
9067|131|P|lightheadedness. Dizziness and lightheadedness can increase the||
9067|132|P|risk of falling.||
9067|133|P|   During pregnancy, this medication should be used only when||
9067|134|P|clearly needed. Discuss the risks and benefits with your doctor.||
9067|135|P|   Spironolactone and hydrochlorothiazide both pass into breast||
9067|136|P|milk but are unlikely to harm a nursing infant. Consult your||
9067|137|P|doctor before breastfeeding.||
9067|138|B|||
9067|139|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
9067|140|I|   Drug interactions may change how your medications work or||
9067|141|I|increase your risk for serious side effects. This document does||
9067|142|I|not contain all possible drug interactions. Keep a list of all||
9067|143|I|the products you use (including prescription/nonprescription||
9067|144|I|drugs and herbal products) and share it with your doctor and||
9067|145|I|pharmacist. Do not start, stop, or change the dosage of any||
9067|146|I|medicines without your doctor's approval.||
9067|147|I|   Some products that may interact with this drug include:||
9067|148|I|dofetilide, lithium, other products that may affect potassium||
9067|149|I|levels (such as eplerenone, tacrolimus, cyclosporine, birth||
9067|150|I|control pills containing drospirenone, other diuretics like||
9067|151|I|amiloride/triamterene, ACE inhibitors like benazepril/captopril,||
9067|152|I|angiotensin receptor antagonists like losartan/valsartan).||
9067|153|I|   Some products have ingredients that could raise your blood||
9067|154|I|pressure or worsen your heart failure. Tell your pharmacist what||
9067|155|I|products you are using, and ask how to use them safely||
9067|156|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
9067|157|I|ibuprofen/naproxen).||
9067|158|I|   This medication may interfere with certain lab tests (such as||
9067|159|I|parathyroid test, protein-bound iodide test), possibly causing||
9067|160|I|false test results. Make sure lab personnel and all your doctors||
9067|161|I|know you use this drug.||
9067|162|B|||
9067|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9067|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9067|165|O|poison control center right away. US residents can call||
9067|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9067|167|O|Symptoms of overdose may include: severe dizziness, fainting,||
9067|168|O|confusion.||
9067|169|B|||
9067|170|N|NOTES:  Do not share this medication with others.||
9067|171|N|   Lifestyle changes such as stress reduction programs, exercise,||
9067|172|N|and dietary changes may increase the effectiveness of this||
9067|173|N|medicine. Talk to your doctor or pharmacist about lifestyle||
9067|174|N|changes that might benefit you.||
9067|175|N|   Lab and/or medical tests (including kidney function, blood||
9067|176|N|mineral levels such as potassium, skin exams, cholesterol levels)||
9067|177|N|should be done while you are taking this medication. Keep all||
9067|178|N|medical and lab appointments. Consult your doctor for more||
9067|179|N|details.||
9067|180|N|   Check your blood pressure regularly while taking this||
9067|181|N|medication, especially when you first start this drug or when||
9067|182|N|your dose is changed. Learn how to monitor your own blood||
9067|183|N|pressure at home, and share the results with your doctor.||
9067|184|B|||
9067|185|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9067|186|D|remember. If it is near the time of the next dose, skip the||
9067|187|D|missed dose. Take your next dose at the regular time. Do not||
9067|188|D|double the dose to catch up.||
9067|189|B|||
9067|190|R|STORAGE:  Store at room temperature away from light and moisture.||
9067|191|R|Do not store in the bathroom. Keep all medications away from||
9067|192|R|children and pets.||
9067|193|R|   Do not flush medications down the toilet or pour them into a||
9067|194|R|drain unless instructed to do so. Properly discard this product||
9067|195|R|when it is expired or no longer needed. Consult your pharmacist||
9067|196|R|or local waste disposal company.||
9067|197|B|||
9067|198|A|Information last revised March 2025.||
9067|199|A|Copyright(c) 2025 First Databank, Inc.||
9067|200|B|||
9069|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9069|002|Z|does NOT have all possible information about this product. This||
9069|003|Z|information does not assure that this product is safe, effective,||
9069|004|Z|or appropriate for you. This information is not individual||
9069|005|Z|medical advice and does not substitute for the advice of your||
9069|006|Z|health care professional. Always ask your health care||
9069|007|Z|professional for complete information about this product and your||
9069|008|Z|specific health needs.||
9069|009|B|||
9069|010|T|ACYCLOVIR - ORAL||
9069|011|F|(ay-SYE-kloe-vir)||
9069|012|B|||
9069|013|C|COMMON BRAND NAME(S): Zovirax||
9069|014|B|||
9069|015|U|USES:  Acyclovir is used to treat infections caused by certain||
9069|016|U|types of viruses. It treats cold sores around the mouth (caused||
9069|017|U|by herpes simplex), shingles (caused by herpes zoster), and||
9069|018|U|chickenpox.||
9069|019|U|   This medication is also used to treat outbreaks of genital||
9069|020|U|herpes. In people with frequent outbreaks, acyclovir is used to||
9069|021|U|help reduce the number of future episodes.||
9069|022|U|   Acyclovir is an antiviral drug. However, it is not a cure for||
9069|023|U|these infections. The viruses that cause these infections||
9069|024|U|continue to live in the body even between outbreaks. Acyclovir||
9069|025|U|decreases the severity and length of these outbreaks. It helps||
9069|026|U|the sores heal faster, keeps new sores from forming, and||
9069|027|U|decreases pain/itching. This medication may also help reduce how||
9069|028|U|long pain remains after the sores heal. In addition, in people||
9069|029|U|with a weakened immune system, acyclovir can decrease the risk of||
9069|030|U|the virus spreading to other parts of the body and causing||
9069|031|U|serious infections.||
9069|032|B|||
9069|033|H|HOW TO USE:  Take this medication by mouth with or without food||
9069|034|H|as directed by your doctor, usually 2 to 5 times a day. Drink||
9069|035|H|plenty of fluids while taking this medication unless your doctor||
9069|036|H|directs you otherwise.||
9069|037|H|   If you are using the liquid form of this medication, shake the||
9069|038|H|bottle well before each dose. Carefully measure the dose using a||
9069|039|H|special measuring device/spoon. Do not use a household spoon||
9069|040|H|because you may not get the correct dose.||
9069|041|H|   This medication works best when started at the first sign of||
9069|042|H|an outbreak, as directed by your doctor. It may not work as well||
9069|043|H|if you delay treatment.||
9069|044|H|   The dosage is based on your medical condition and response to||
9069|045|H|treatment. Children's dosage is also based on weight.||
9069|046|H|   This medication works best when the amount of drug in your||
9069|047|H|body is kept at a constant level. Take this drug at evenly spaced||
9069|048|H|intervals. To help you remember, take it at the same times each||
9069|049|H|day.||
9069|050|H|   Continue to take this medication until the full prescribed||
9069|051|H|amount is finished. Do not change your dose, skip any doses, or||
9069|052|H|stop this medication early without your doctor's approval.||
9069|053|H|   Tell your doctor if your condition lasts or gets worse.||
9069|054|B|||
9069|055|S|SIDE EFFECTS:  Nausea, diarrhea, headache, or vomiting may occur.||
9069|056|S|If any of these effects last or get worse, tell your doctor or||
9069|057|S|pharmacist promptly.||
9069|058|S|   Remember that this medication has been prescribed because your||
9069|059|S|doctor has judged that the benefit to you is greater than the||
9069|060|S|risk of side effects. Many people using this medication do not||
9069|061|S|have serious side effects.||
9069|062|S|   Tell your doctor right away if you have any serious side||
9069|063|S|effects, including: dizziness, drowsiness, signs of kidney||
9069|064|S|problems (such as a change in the amount of urine, unusual||
9069|065|S|back/side pain), mental/mood changes (such as agitation,||
9069|066|S|confusion, hallucinations), shaky/unsteady movement, unusual||
9069|067|S|tiredness, fast heartbeat, easy bruising/bleeding, new fever,||
9069|068|S|bloody/dark urine, severe stomach/abdominal pain, yellowing||
9069|069|S|eyes/skin.||
9069|070|S|   Get medical help right away if you have any very serious side||
9069|071|S|effects, including: sudden vision changes, trouble speaking, loss||
9069|072|S|of consciousness, seizures.||
9069|073|S|   A very serious allergic reaction to this drug is rare.||
9069|074|S|However, get medical help right away if you notice any symptoms||
9069|075|S|of a serious allergic reaction, including: fever that doesn't go||
9069|076|S|away, new or worsening lymph node swelling, rash,||
9069|077|S|itching/swelling (especially of the face/tongue/throat), severe||
9069|078|S|dizziness, trouble breathing.||
9069|079|S|   This is not a complete list of possible side effects. If you||
9069|080|S|notice other effects not listed above, contact your doctor or||
9069|081|S|pharmacist.||
9069|082|S|   In the US -||
9069|083|S|   Call your doctor for medical advice about side effects. You||
9069|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9069|085|S|www.fda.gov/medwatch.||
9069|086|S|   In Canada - Call your doctor for medical advice about side||
9069|087|S|effects. You may report side effects to Health Canada at||
9069|088|S|1-866-234-2345.||
9069|089|B|||
9069|090|P|PRECAUTIONS:  Before taking acyclovir, tell your doctor or||
9069|091|P|pharmacist if you are allergic to it; or to valacyclovir; or if||
9069|092|P|you have any other allergies. This product may contain inactive||
9069|093|P|ingredients, which can cause allergic reactions or other||
9069|094|P|problems. Talk to your pharmacist for more details.||
9069|095|P|   Before using this medication, tell your doctor or pharmacist||
9069|096|P|your medical history, especially of: kidney problems, immune||
9069|097|P|system problems.||
9069|098|P|   Before having surgery, tell your doctor or dentist about all||
9069|099|P|the products you use (including prescription drugs,||
9069|100|P|nonprescription drugs, and herbal products).||
9069|101|P|   Tell your health care professional that you are using||
9069|102|P|acyclovir before having any immunizations/vaccinations (such as||
9069|103|P|vaccines against the varicella virus).||
9069|104|P|   Older adults may be more sensitive to the side effects of the||
9069|105|P|drug, especially kidney problems (change in the amount of urine,||
9069|106|P|back/side pain), dizziness, drowsiness, and mental/mood changes||
9069|107|P|(such as confusion, hallucinations, loss of consciousness).||
9069|108|P|   Acyclovir does not protect against the spread of genital||
9069|109|P|herpes. To lower the chance of giving herpes to your partner, do||
9069|110|P|not have sexual contact during an outbreak or if you have||
9069|111|P|symptoms. You can spread genital herpes even if you do not have||
9069|112|P|symptoms. Always use an effective barrier method (latex or||
9069|113|P|polyurethane condoms/dental dams) during all sexual activity.||
9069|114|P|Consult your doctor or pharmacist for more details.||
9069|115|P|   During pregnancy, this medication should be used only when||
9069|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
9069|117|P|   This medication passes into breast milk, but is unlikely to||
9069|118|P|harm a nursing infant. Consult your doctor before breastfeeding.||
9069|119|B|||
9069|120|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9069|121|I|medications work or increase your risk for serious side effects.||
9069|122|I|This document does not contain all possible drug interactions.||
9069|123|I|Keep a list of all the products you use (including||
9069|124|I|prescription/nonprescription drugs and herbal products) and share||
9069|125|I|it with your doctor and pharmacist. Do not start, stop, or change||
9069|126|I|the dosage of any medicines without your doctor's approval.||
9069|127|I|   Some products that may interact with this drug include: other||
9069|128|I|drugs that may cause kidney problems (including nonsteroidal||
9069|129|I|anti-inflammatory drugs-NSAIDs such as ibuprofen, naproxen).||
9069|130|I|   Acyclovir is very similar to valacyclovir. Do not use||
9069|131|I|medications containing valacyclovir while using acyclovir.||
9069|132|B|||
9069|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9069|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9069|135|O|poison control center right away. US residents can call||
9069|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9069|137|O|Symptoms of overdose may include: change in the amount of urine,||
9069|138|O|extreme tiredness, agitation, loss of consciousness, seizures.||
9069|139|B|||
9069|140|N|NOTES:  Do not share this medication with others.||
9069|141|N|   This medication has been prescribed for your current condition||
9069|142|N|only. Do not use it later for another infection unless your||
9069|143|N|doctor tells you to.||
9069|144|B|||
9069|145|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9069|146|D|remember. If it is near the time of the next dose, skip the||
9069|147|D|missed dose. Take your next dose at the regular time. Do not||
9069|148|D|double the dose to catch up.||
9069|149|B|||
9069|150|R|STORAGE:  Store at room temperature away from light and moisture.||
9069|151|R|Do not store in the bathroom. Keep all medications away from||
9069|152|R|children and pets.||
9069|153|R|   Do not flush medications down the toilet or pour them into a||
9069|154|R|drain unless instructed to do so. Properly discard this product||
9069|155|R|when it is expired or no longer needed. Consult your pharmacist||
9069|156|R|or local waste disposal company.||
9069|157|B|||
9069|158|A|Information last revised November 2025.||
9069|159|A|Copyright(c) 2025 First Databank, Inc.||
9069|160|B|||
9070|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9070|002|Z|does NOT have all possible information about this product. This||
9070|003|Z|information does not assure that this product is safe, effective,||
9070|004|Z|or appropriate for you. This information is not individual||
9070|005|Z|medical advice and does not substitute for the advice of your||
9070|006|Z|health care professional. Always ask your health care||
9070|007|Z|professional for complete information about this product and your||
9070|008|Z|specific health needs.||
9070|009|B|||
9070|010|T|FLECAINIDE - ORAL||
9070|011|F|(fleck-UH-nide)||
9070|012|B|||
9070|013|C|COMMON BRAND NAME(S): Tambocor||
9070|014|B|||
9070|015|W|WARNING:  Though this medication often gives great benefits to||
9070|016|W|people with irregular heartbeat, it may rarely cause a serious||
9070|017|W|new irregular heartbeat. When starting treatment with this drug,||
9070|018|W|your doctor may recommend that you stay in the hospital for||
9070|019|W|proper monitoring. Flecainide should not be used to treat a||
9070|020|W|certain type of irregular heartbeat (persistent atrial||
9070|021|W|fibrillation/flutter). Talk with your doctor about the benefits||
9070|022|W|and risks of taking this medication for your condition.||
9070|023|B|||
9070|024|U|USES:  This medication is used to treat certain types of serious||
9070|025|U|(possibly fatal) irregular heartbeat (such as sustained||
9070|026|U|ventricular tachycardia and paroxysmal supraventricular||
9070|027|U|tachycardia). It is used to restore normal heart rhythm and||
9070|028|U|maintain a regular, steady heartbeat. It is also used to prevent||
9070|029|U|certain types of irregular heartbeat from returning (such as||
9070|030|U|atrial fibrillation). Flecainide is known as an anti-arrhythmic||
9070|031|U|drug. It works by blocking certain electrical signals in the||
9070|032|U|heart that can cause an irregular heartbeat. Treating an||
9070|033|U|irregular heartbeat can decrease the risk for blood clots, and||
9070|034|U|this effect can reduce your risk of heart attack or stroke.||
9070|035|U|   Older adults should discuss the risks and benefits of this||
9070|036|U|medication with their doctor or pharmacist, as well as other||
9070|037|U|effective and possibly safer treatments.||
9070|038|B|||
9070|039|H|HOW TO USE:  Take this medication by mouth with or without food||
9070|040|H|as directed by your doctor, usually twice daily.||
9070|041|H|   The dosage is based on your age, medical condition, response||
9070|042|H|to treatment, and other medications you may be taking. Be sure to||
9070|043|H|tell your doctor and pharmacist about all the products you use||
9070|044|H|(including prescription drugs, nonprescription drugs, and herbal||
9070|045|H|products).||
9070|046|H|   Use this medication regularly to get the most benefit from it.||
9070|047|H|To help you remember, take it at the same times each day.||
9070|048|H|   Tell your doctor if your condition does not get better or if||
9070|049|H|it gets worse.||
9070|050|B|||
9070|051|S|SIDE EFFECTS:  See also Warning section.||
9070|052|S|   Dizziness, vision problems (such as blurred vision, problems||
9070|053|S|focusing, seeing spots), headache, nausea, shaking, tiredness, or||
9070|054|S|weakness may occur. If any of these effects last or get worse,||
9070|055|S|tell your doctor or pharmacist promptly.||
9070|056|S|   Remember that this medication has been prescribed because your||
9070|057|S|doctor has judged that the benefit to you is greater than the||
9070|058|S|risk of side effects. Many people using this medication do not||
9070|059|S|have serious side effects.||
9070|060|S|   Tell your doctor right away if you have any serious side||
9070|061|S|effects, including: new or worsening symptoms of heart failure||
9070|062|S|(such as shortness of breath, swelling ankles/feet, unusual||
9070|063|S|tiredness, unusual/sudden weight gain).||
9070|064|S|   Get medical help right away if you have any very serious side||
9070|065|S|effects, including: faster/more irregular heartbeat, severe||
9070|066|S|dizziness, fainting.||
9070|067|S|   A very serious allergic reaction to this drug is rare.||
9070|068|S|However, get medical help right away if you notice any symptoms||
9070|069|S|of a serious allergic reaction, including: rash, itching/swelling||
9070|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9070|071|S|breathing.||
9070|072|S|   This is not a complete list of possible side effects. If you||
9070|073|S|notice other effects not listed above, contact your doctor or||
9070|074|S|pharmacist.||
9070|075|S|   In the US -||
9070|076|S|   Call your doctor for medical advice about side effects. You||
9070|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9070|078|S|www.fda.gov/medwatch.||
9070|079|S|   In Canada - Call your doctor for medical advice about side||
9070|080|S|effects. You may report side effects to Health Canada at||
9070|081|S|1-866-234-2345.||
9070|082|B|||
9070|083|P|PRECAUTIONS:  Before taking flecainide, tell your doctor or||
9070|084|P|pharmacist if you are allergic to it; or if you have any other||
9070|085|P|allergies. This product may contain inactive ingredients, which||
9070|086|P|can cause allergic reactions or other problems. Talk to your||
9070|087|P|pharmacist for more details.||
9070|088|P|   Before using this medication, tell your doctor or pharmacist||
9070|089|P|your medical history, especially of: kidney problems, liver||
9070|090|P|problems, other heart problems (such as previous heart attack,||
9070|091|P|heart pacemaker).||
9070|092|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9070|093|P|can make you more dizzy. Do not drive, use machinery, or do||
9070|094|P|anything that needs alertness until you can do it safely. Limit||
9070|095|P|alcoholic beverages. Talk to your doctor if you are using||
9070|096|P|marijuana (cannabis).||
9070|097|P|   Before having surgery, tell your doctor or dentist about all||
9070|098|P|the products you use (including prescription drugs,||
9070|099|P|nonprescription drugs, and herbal products).||
9070|100|P|   Flecainide may cause a condition that affects the heart rhythm||
9070|101|P|(QT prolongation). QT prolongation can rarely cause serious||
9070|102|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
9070|103|P|as severe dizziness, fainting) that need medical attention right||
9070|104|P|away.||
9070|105|P|   The risk of QT prolongation may be increased if you have||
9070|106|P|certain medical conditions or are taking other drugs that may||
9070|107|P|cause QT prolongation. Before using flecainide, tell your doctor||
9070|108|P|or pharmacist of all the drugs you take and if you have any of||
9070|109|P|the following conditions: certain heart problems (heart failure,||
9070|110|P|slow heartbeat, QT prolongation in the EKG), family history of||
9070|111|P|certain heart problems (QT prolongation in the EKG, sudden||
9070|112|P|cardiac death).||
9070|113|P|   Low levels of potassium or magnesium in the blood may also||
9070|114|P|increase your risk of QT prolongation. This risk may increase if||
9070|115|P|you use certain drugs (such as diuretics/"water pills") or if you||
9070|116|P|have conditions such as severe sweating, diarrhea, or vomiting.||
9070|117|P|Talk to your doctor about using flecainide safely.||
9070|118|P|   Older adults may be more sensitive to the side effects of this||
9070|119|P|drug, especially QT prolongation (see above).||
9070|120|P|   During pregnancy, this medication should be used only when||
9070|121|P|clearly needed. Discuss the risks and benefits with your doctor.||
9070|122|P|   This medication passes into breast milk. However, this drug is||
9070|123|P|unlikely to harm a nursing infant. Consult your doctor before||
9070|124|P|breastfeeding.||
9070|125|B|||
9070|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9070|127|I|medications work or increase your risk for serious side effects.||
9070|128|I|This document does not contain all possible drug interactions.||
9070|129|I|Keep a list of all the products you use (including||
9070|130|I|prescription/nonprescription drugs and herbal products) and share||
9070|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
9070|132|I|the dosage of any medicines without your doctor's approval.||
9070|133|I|   Many drugs besides flecainide may affect the heart rhythm (QT||
9070|134|I|prolongation), including amiodarone, dofetilide, pimozide,||
9070|135|I|procainamide, quinidine, sotalol, and macrolide antibiotics (such||
9070|136|I|as erythromycin), among others.||
9070|137|I|   Other medications can affect the removal of flecainide from||
9070|138|I|your body, which may affect how flecainide works. Examples||
9070|139|I|include cimetidine, fluconazole, certain HIV protease inhibitors||
9070|140|I|(such as tipranavir), ritonavir, anti-seizure drugs (such as||
9070|141|I|phenytoin, phenobarbital), among others.||
9070|142|B|||
9070|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9070|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9070|145|O|poison control center right away. US residents can call||
9070|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9070|147|O|Symptoms of overdose may include: severe nausea/vomiting,||
9070|148|O|seizures, very slow heartbeat, severe dizziness, fainting.||
9070|149|B|||
9070|150|N|NOTES:  Do not share this medication with others.||
9070|151|N|   Lab and/or medical tests (such as EKG) should be done while||
9070|152|N|you are taking this medication. Keep all medical and lab||
9070|153|N|appointments. Consult your doctor for more details.||
9070|154|B|||
9070|155|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9070|156|D|remember. If it is near the time of the next dose, skip the||
9070|157|D|missed dose. Take your next dose at the regular time. Do not||
9070|158|D|double the dose to catch up.||
9070|159|B|||
9070|160|R|STORAGE:  Store at room temperature away from light and moisture.||
9070|161|R|Do not store in the bathroom. Keep all medications away from||
9070|162|R|children and pets.||
9070|163|R|   Do not flush medications down the toilet or pour them into a||
9070|164|R|drain unless instructed to do so. Properly discard this product||
9070|165|R|when it is expired or no longer needed. Consult your pharmacist||
9070|166|R|or local waste disposal company.||
9070|167|B|||
9070|168|M|MEDICAL ALERT:  Your condition can cause complications in a||
9070|169|M|medical emergency. For information about enrolling in MedicAlert,||
9070|170|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9070|171|B|||
9070|172|A|Information last revised March 2025.||
9070|173|A|Copyright(c) 2025 First Databank, Inc.||
9070|174|B|||
9071|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9071|002|Z|does NOT have all possible information about this product. This||
9071|003|Z|information does not assure that this product is safe, effective,||
9071|004|Z|or appropriate for you. This information is not individual||
9071|005|Z|medical advice and does not substitute for the advice of your||
9071|006|Z|health care professional. Always ask your health care||
9071|007|Z|professional for complete information about this product and your||
9071|008|Z|specific health needs.||
9071|009|B|||
9071|010|T|SULFAMETHOXAZOLE/TRIMETHOPRIM- ORAL||
9071|011|F|(sull-fuh-meth-OX-uh-zole/try-METH-oh-prim)||
9071|012|B|||
9071|013|C|COMMON BRAND NAME(S): Bactrim, Septra||
9071|014|B|||
9071|015|U|USES:  This medication is a combination of two antibiotics:||
9071|016|U|sulfamethoxazole and trimethoprim. It is used to treat a wide||
9071|017|U|variety of bacterial infections (such as middle ear, urine,||
9071|018|U|respiratory, and intestinal infections). It is also used to||
9071|019|U|prevent and treat a certain type of pneumonia||
9071|020|U|(pneumocystis-type).||
9071|021|U|   This medication should not be used by children less than 2||
9071|022|U|months of age due to the risk of serious side effects.||
9071|023|U|   This medication treats only certain types of infections. It||
9071|024|U|will not work for viral infections (such as flu). Unnecessary use||
9071|025|U|or misuse of any antibiotic can lead to its decreased||
9071|026|U|effectiveness.||
9071|027|B|||
9071|028|H|HOW TO USE:  Take this medication by mouth with a full glass of||
9071|029|H|water (8 ounces / 240 milliliters) as directed by your doctor,.||
9071|030|H|If stomach upset occurs, take with food or milk. Drink plenty of||
9071|031|H|fluids while taking this medication to lower the unlikely risk of||
9071|032|H|kidney stones forming, unless your doctor advises you otherwise.||
9071|033|H|The dosage is based on your medical condition and response to||
9071|034|H|treatment.||
9071|035|H|   For the best effect, take this antibiotic at evenly spaced||
9071|036|H|times. To help you remember, take this medication at the same||
9071|037|H|time(s) every day.||
9071|038|H|   Continue to take this medication until the full prescribed||
9071|039|H|amount is finished, even if symptoms disappear after a few days.||
9071|040|H|Stopping the medication too early may result in a return of the||
9071|041|H|infection.||
9071|042|H|   Tell your doctor if your condition lasts or gets worse.||
9071|043|B|||
9071|044|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, and loss of appetite||
9071|045|S|may occur. If any of these effects last or get worse, tell your||
9071|046|S|doctor or pharmacist promptly.||
9071|047|S|   Remember that this medication has been prescribed because your||
9071|048|S|doctor has judged that the benefit to you is greater than the||
9071|049|S|risk of side effects. Many people using this medication do not||
9071|050|S|have serious side effects.||
9071|051|S|   Tell your doctor right away if you have any serious side||
9071|052|S|effects, including: muscle weakness, mental/mood changes, signs||
9071|053|S|of kidney problems (such as change in the amount of urine, blood||
9071|054|S|in the urine), extreme drowsiness, signs of low blood sugar (such||
9071|055|S|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
9071|056|S|vision, dizziness, or tingling hands/feet).||
9071|057|S|   Get medical help right away if you have any very serious side||
9071|058|S|effects, including: headache that doesn't go away, neck||
9071|059|S|stiffness, seizures, slow/irregular heartbeat.||
9071|060|S|   This medication may rarely cause a severe intestinal condition||
9071|061|S|due to a bacteria called C. difficile. This condition may occur||
9071|062|S|during treatment or weeks to months after treatment has stopped.||
9071|063|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9071|064|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9071|065|S|stool.||
9071|066|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9071|067|S|products because they may make symptoms worse.||
9071|068|S|   Use of this medication for prolonged or repeated periods may||
9071|069|S|result in oral thrush or a new yeast infection. Contact your||
9071|070|S|doctor if you notice white patches in your mouth, a change in||
9071|071|S|vaginal discharge, or other new symptoms.||
9071|072|S|   This medication may rarely cause serious (possibly fatal)||
9071|073|S|allergic reactions and other side effects such as a severe||
9071|074|S|peeling skin rash (such as Stevens-Johnson syndrome), blood||
9071|075|S|disorders (such as agranulocytosis, aplastic anemia), liver||
9071|076|S|damage, or lung injury. If you notice any of the following, get||
9071|077|S|medical help right away: sore throat or fever that doesn't go||
9071|078|S|away, cough that doesn't go away, nausea/vomiting that doesn't||
9071|079|S|stop, skin rash/blisters, itching/swelling (especially of the||
9071|080|S|face/tongue/throat), new or worsening lymph node swelling, severe||
9071|081|S|dizziness, paleness, chest pain, joint pain/aches, trouble||
9071|082|S|breathing, easy bleeding/bruising, yellowing eyes/skin, unusual||
9071|083|S|tiredness, dark urine.||
9071|084|S|   This is not a complete list of possible side effects. If you||
9071|085|S|notice other effects not listed above, contact your doctor or||
9071|086|S|pharmacist.||
9071|087|S|   In the US -||
9071|088|S|   Call your doctor for medical advice about side effects. You||
9071|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9071|090|S|www.fda.gov/medwatch.||
9071|091|S|   In Canada - Call your doctor for medical advice about side||
9071|092|S|effects. You may report side effects to Health Canada at||
9071|093|S|1-866-234-2345.||
9071|094|B|||
9071|095|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9071|096|P|pharmacist if you are allergic to sulfamethoxazole or||
9071|097|P|trimethoprim; or to sulfa medications; or if you have any other||
9071|098|P|allergies. This product may contain inactive ingredients, which||
9071|099|P|can cause allergic reactions or other problems. Talk to your||
9071|100|P|pharmacist for more details.||
9071|101|P|   Before using this medication, tell your doctor or pharmacist||
9071|102|P|your medical history, especially of: kidney disease, liver||
9071|103|P|disease, certain blood disorders (such as porphyria, anemia due||
9071|104|P|to folate vitamin deficiency), history of blood disorders caused||
9071|105|P|by trimethoprim or sulfa medications, vitamin deficiency (folate||
9071|106|P|or folic acid), severe allergies, asthma, decreased bone marrow||
9071|107|P|function (bone marrow suppression), a certain metabolic disorder||
9071|108|P|(G6PD deficiency), underactive thyroid, mineral imbalances (such||
9071|109|P|as high level of potassium or low level of sodium in the blood).||
9071|110|P|   This medication may cause live bacterial vaccines (such as||
9071|111|P|typhoid vaccine) to not work well. Tell your health care||
9071|112|P|professional that you are using this medication before having any||
9071|113|P|immunizations/vaccinations.||
9071|114|P|   Before having surgery, tell your doctor or dentist about all||
9071|115|P|the products you use (including prescription drugs,||
9071|116|P|nonprescription drugs, and herbal products).||
9071|117|P|   This medication may make you more sensitive to the sun. Limit||
9071|118|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9071|119|P|sunscreen and wear protective clothing when outdoors. Get medical||
9071|120|P|help right away if you get sunburned or have skin||
9071|121|P|blisters/redness.||
9071|122|P|   If you have diabetes, this product may affect your blood||
9071|123|P|sugar. Check your blood sugar regularly as directed and share the||
9071|124|P|results with your doctor. Tell your doctor right away if you have||
9071|125|P|symptoms of low blood sugar (see Side Effects section). Your||
9071|126|P|doctor may need to adjust your diabetes medication, exercise||
9071|127|P|program, or diet.||
9071|128|P|   Older adults may be more sensitive to the side effects of this||
9071|129|P|drug, especially skin reactions, blood disorders, easy||
9071|130|P|bleeding/bruising, and a high potassium blood level.||
9071|131|P|   Patients with AIDS may be more sensitive to the side effects||
9071|132|P|of this drug, especially skin reactions, fever, and blood||
9071|133|P|disorders.||
9071|134|P|   Tell your doctor if you are pregnant or plan to become||
9071|135|P|pregnant. You should not become pregnant while using||
9071|136|P|sulfamethoxazole/trimethoprim. This medication may harm an unborn||
9071|137|P|baby. If you become pregnant, talk to your doctor right away||
9071|138|P|about the risks and benefits of this medication.||
9071|139|P|   This drug passes into breast milk. This drug may have||
9071|140|P|undesirable effects on infants who are ill or premature or have||
9071|141|P|certain disorders (jaundice, high blood levels of bilirubin, G6PD||
9071|142|P|deficiency). Breastfeeding is not recommended for infants with||
9071|143|P|these conditions. Consult your doctor before breastfeeding.||
9071|144|B|||
9071|145|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9071|146|I|medications work or increase your risk for serious side effects.||
9071|147|I|This document does not contain all possible drug interactions.||
9071|148|I|Keep a list of all the products you use (including||
9071|149|I|prescription/nonprescription drugs and herbal products) and share||
9071|150|I|it with your doctor and pharmacist. Do not start, stop, or change||
9071|151|I|the dosage of any medicines without your doctor's approval.||
9071|152|I|   Some products that may interact with this drug include: "blood||
9071|153|I|thinners" (such as warfarin), dofetilide, methenamine,||
9071|154|I|methotrexate.||
9071|155|I|   This medication may interfere with certain lab tests, possibly||
9071|156|I|causing false test results. Make sure lab personnel and all your||
9071|157|I|doctors know you use this drug.||
9071|158|B|||
9071|159|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9071|160|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9071|161|O|poison control center right away. US residents can call||
9071|162|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9071|163|O|Symptoms of overdose may include: severe||
9071|164|O|nausea/vomiting/diarrhea, severe dizziness or drowsiness,||
9071|165|O|mental/mood changes.||
9071|166|B|||
9071|167|N|NOTES:  Do not share this medication with others.||
9071|168|N|   This medication has been prescribed for your current condition||
9071|169|N|only. Do not use it later for another infection unless your||
9071|170|N|doctor tells you to.||
9071|171|N|   If taking this medication for a long time, lab and/or medical||
9071|172|N|tests (such as complete blood count, kidney function, potassium||
9071|173|N|blood level, cultures) should be done while you are taking this||
9071|174|N|medication. Keep all medical and lab appointments. Consult your||
9071|175|N|doctor for more details.||
9071|176|B|||
9071|177|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9071|178|D|remember. If it is near the time of the next dose, skip the||
9071|179|D|missed dose. Take your next dose at the regular time. Do not||
9071|180|D|double the dose to catch up.||
9071|181|B|||
9071|182|R|STORAGE:  Store at room temperature away from light and moisture.||
9071|183|R|Do not store in the bathroom. Keep all medications away from||
9071|184|R|children and pets.||
9071|185|R|   Do not flush medications down the toilet or pour them into a||
9071|186|R|drain unless instructed to do so. Properly discard this product||
9071|187|R|when it is expired or no longer needed. Consult your pharmacist||
9071|188|R|or local waste disposal company.||
9071|189|B|||
9071|190|A|Information last revised May 2025.||
9071|191|A|Copyright(c) 2025 First Databank, Inc.||
9071|192|B|||
9073|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9073|002|Z|does NOT have all possible information about this product. This||
9073|003|Z|information does not assure that this product is safe, effective,||
9073|004|Z|or appropriate for you. This information is not individual||
9073|005|Z|medical advice and does not substitute for the advice of your||
9073|006|Z|health care professional. Always ask your health care||
9073|007|Z|professional for complete information about this product and your||
9073|008|Z|specific health needs.||
9073|009|B|||
9073|010|T|DOXYCYCLINE - INJECTION||
9073|011|F|(dox-ee-SYE-kleen)||
9073|012|B|||
9073|013|C|COMMON BRAND NAME(S): Vibramycin||
9073|014|B|||
9073|015|U|USES:  Doxycycline is used to treat a wide variety of bacterial||
9073|016|U|infections. This medication is known as a tetracycline||
9073|017|U|antibiotic. It works by stopping the growth of bacteria.||
9073|018|B|||
9073|019|V|OTHER USES:  This section contains uses of this drug that are not||
9073|020|V|listed in the approved professional labeling for the drug but||
9073|021|V|that may be prescribed by your health care professional. Use this||
9073|022|V|drug for a condition that is listed in this section only if it||
9073|023|V|has been so prescribed by your health care professional.||
9073|024|V|   This medication may also be used to control the build-up of||
9073|025|V|fluid around the lungs (pleural effusion) caused by tumors that||
9073|026|V|have spread to the lungs. For this condition, doxycycline is||
9073|027|V|placed in the space around the lungs through a chest tube.||
9073|028|B|||
9073|029|H|HOW TO USE:  This medication is given by injection into a vein as||
9073|030|H|directed by your doctor, usually once or twice daily. It should||
9073|031|H|be injected slowly over at least 1 hour (usual range is 1 to 4||
9073|032|H|hours). The dosage is based on your medical condition and||
9073|033|H|response to treatment. Children's dosage is also based on weight.||
9073|034|H|   If you are giving this medication to yourself at home, learn||
9073|035|H|all preparation and usage instructions from your health care||
9073|036|H|professional. Before using, check this product for particles or||
9073|037|H|discoloration. If either is present, do not use the liquid. Learn||
9073|038|H|how to store and discard medical supplies safely.||
9073|039|H|   For the best effect, use this antibiotic at evenly spaced||
9073|040|H|times. To help you remember, use this medication at the same||
9073|041|H|time(s) every day.||
9073|042|H|   Continue to use this medication for the full time prescribed,||
9073|043|H|even if symptoms disappear after a few days. Stopping the||
9073|044|H|medication too early may result in a return of the infection.||
9073|045|H|   Tell your doctor if your condition lasts or gets worse.||
9073|046|B|||
9073|047|S|SIDE EFFECTS:  Diarrhea, loss of appetite, nausea, vomiting,||
9073|048|S|headache, or rectal discomfort may occur. If any of these effects||
9073|049|S|last or get worse, tell your doctor or pharmacist promptly.||
9073|050|S|   Remember that this medication has been prescribed because your||
9073|051|S|doctor has judged that the benefit to you is greater than the||
9073|052|S|risk of side effects. Many people using this medication do not||
9073|053|S|have serious side effects.||
9073|054|S|   Tell your doctor right away if you have serious side effects||
9073|055|S|such as: nausea/vomiting that doesn't stop, signs of kidney||
9073|056|S|problems (such as change in the amount of urine), unusual||
9073|057|S|tiredness, redness/swelling/pain at the injection site, weakness,||
9073|058|S|hearing changes (such as ringing in the ears, decreased hearing),||
9073|059|S|stomach/abdominal pain.||
9073|060|S|   Tetracycline drugs such as doxycycline may rarely cause||
9073|061|S|increased pressure around the brain (intracranial||
9073|062|S|hypertension-IH). The risk of this side effect is greater for||
9073|063|S|women of childbearing age who are overweight or who have had IH||
9073|064|S|in the past. If IH develops, it usually goes away after||
9073|065|S|doxycycline is stopped; however, there is a chance of permanent||
9073|066|S|vision loss or blindness. Get medical help right away if you||
9073|067|S|have: nausea/vomiting that doesn't stop, headache that is severe||
9073|068|S|or doesn't stop, vision changes (such as blurred/double vision,||
9073|069|S|decreased vision, sudden blindness).||
9073|070|S|   This medication may rarely cause a severe intestinal condition||
9073|071|S|due to a bacteria called C. difficile. This condition may occur||
9073|072|S|during treatment or weeks to months after treatment has stopped.||
9073|073|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9073|074|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9073|075|S|stool.||
9073|076|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9073|077|S|products because they may make symptoms worse.||
9073|078|S|   Use of this medication for prolonged or repeated periods may||
9073|079|S|result in oral thrush or a new vaginal yeast infection. Contact||
9073|080|S|your doctor if you notice white patches in your mouth, a change||
9073|081|S|in vaginal discharge, or other new symptoms.||
9073|082|S|   A very serious allergic reaction to this drug is rare.||
9073|083|S|However, get medical help right away if you notice any symptoms||
9073|084|S|of a serious allergic reaction, including: fever that doesn't go||
9073|085|S|away, new or worsening lymph node swelling, rash,||
9073|086|S|itching/swelling (especially of the face/tongue/throat), severe||
9073|087|S|dizziness, trouble breathing.||
9073|088|S|   This is not a complete list of possible side effects. If you||
9073|089|S|notice other effects not listed above, contact your doctor or||
9073|090|S|pharmacist.||
9073|091|S|   In the US -||
9073|092|S|   Call your doctor for medical advice about side effects. You||
9073|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9073|094|S|www.fda.gov/medwatch.||
9073|095|S|   In Canada - Call your doctor for medical advice about side||
9073|096|S|effects. You may report side effects to Health Canada at||
9073|097|S|1-866-234-2345.||
9073|098|B|||
9073|099|P|PRECAUTIONS:  See also Side Effects section.||
9073|100|P|   Before using doxycycline, tell your doctor or pharmacist if||
9073|101|P|you are allergic to it; or to other tetracycline medication (such||
9073|102|P|as minocycline, tetracycline); or if you have any other||
9073|103|P|allergies. This product may contain inactive ingredients, which||
9073|104|P|can cause allergic reactions or other problems. Talk to your||
9073|105|P|pharmacist for more details.||
9073|106|P|   Before using this medication, tell your doctor or pharmacist||
9073|107|P|your medical history, especially of: liver disease, lupus.||
9073|108|P|   Doxycycline may cause live bacterial vaccines (such as typhoid||
9073|109|P|vaccine) to not work well. Tell your health care professional||
9073|110|P|that you are using doxycycline before having any||
9073|111|P|immunizations/vaccinations.||
9073|112|P|   This medication may make you more sensitive to the sun. Limit||
9073|113|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9073|114|P|sunscreen and wear protective clothing when outdoors. Tell your||
9073|115|P|doctor right away if you get sunburned or have skin||
9073|116|P|blisters/redness.||
9073|117|P|   Before having surgery, tell your doctor or dentist about all||
9073|118|P|the products you use (including prescription drugs,||
9073|119|P|nonprescription drugs, and herbal products).||
9073|120|P|   Children younger than 8 years may be more sensitive to the||
9073|121|P|side effects of doxycycline, especially tooth discoloration.||
9073|122|P|Tooth discoloration has also occurred in older children and young||
9073|123|P|adults. Discuss the risks and benefits of this medication with||
9073|124|P|the doctor.||
9073|125|P|   Tell your doctor if you are pregnant or plan to become||
9073|126|P|pregnant. You should not become pregnant while using doxycycline.||
9073|127|P|Doxycycline may harm an unborn baby. If you become pregnant, talk||
9073|128|P|to your doctor right away about the risks and benefits of this||
9073|129|P|medication.||
9073|130|P|   This medication passes into breast milk. Consult your doctor||
9073|131|P|before breastfeeding.||
9073|132|B|||
9073|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9073|134|I|medications work or increase your risk for serious side effects.||
9073|135|I|This document does not contain all possible drug interactions.||
9073|136|I|Keep a list of all the products you use (including||
9073|137|I|prescription/nonprescription drugs and herbal products) and share||
9073|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
9073|139|I|the dosage of any medicines without your doctor's approval.||
9073|140|I|   Some products that may interact with this drug include:||
9073|141|I|retinoid medications taken by mouth (such as acitretin,||
9073|142|I|isotretinoin).||
9073|143|I|   This medication may interfere with certain lab tests (such as||
9073|144|I|some urine tests for sugar), possibly causing false test results.||
9073|145|I|Make sure lab personnel and all your doctors know you use this||
9073|146|I|drug.||
9073|147|B|||
9073|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9073|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9073|150|O|poison control center right away. US residents can call||
9073|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9073|152|B|||
9073|153|N|NOTES:  If you are using this drug for a long time, lab and/or||
9073|154|N|medical tests (such as complete blood count, kidney/liver||
9073|155|N|function) should be done while you are using this medication.||
9073|156|N|Keep all medical and lab appointments. Consult your doctor for||
9073|157|N|more details.||
9073|158|B|||
9073|159|D|MISSED DOSE:  It is important to get each dose of this medication||
9073|160|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9073|161|D|right away for a new dosing schedule. Do not double the dose to||
9073|162|D|catch up.||
9073|163|B|||
9073|164|R|STORAGE:  Consult the product instructions and your pharmacist||
9073|165|R|for storage details. Keep all medications away from children and||
9073|166|R|pets.||
9073|167|R|   Do not flush medications down the toilet or pour them into a||
9073|168|R|drain unless instructed to do so. Properly discard this product||
9073|169|R|when it is expired or no longer needed. Consult your pharmacist||
9073|170|R|or local waste disposal company.||
9073|171|B|||
9073|172|A|Information last revised September 2025.||
9073|173|A|Copyright(c) 2025 First Databank, Inc.||
9073|174|B|||
9077|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9077|002|Z|does NOT have all possible information about this product. This||
9077|003|Z|information does not assure that this product is safe, effective,||
9077|004|Z|or appropriate for you. This information is not individual||
9077|005|Z|medical advice and does not substitute for the advice of your||
9077|006|Z|health care professional. Always ask your health care||
9077|007|Z|professional for complete information about this product and your||
9077|008|Z|specific health needs.||
9077|009|B|||
9077|010|T|NICOTINE PATCH - TRANSDERMAL||
9077|011|F|(NICK-oh-teen)||
9077|012|B|||
9077|013|C|COMMON BRAND NAME(S): Habitrol, Nicoderm CQ, Nicotrol||
9077|014|B|||
9077|015|U|USES:  This medication can help you quit smoking by replacing the||
9077|016|U|nicotine in cigarettes. The nicotine in tobacco is an important||
9077|017|U|part of cigarette addiction. When you stop smoking, your nicotine||
9077|018|U|levels drop quickly. This drop can cause withdrawal symptoms such||
9077|019|U|as craving tobacco, nervousness, irritability, headache, weight||
9077|020|U|gain, and difficulty concentrating.||
9077|021|U|   Stopping smoking is hard and your chance of success is best||
9077|022|U|when you are ready and have made a commitment to quit. Nicotine||
9077|023|U|replacement products are part of a total stop-smoking program||
9077|024|U|that includes behavior change, counseling, and support. Smoking||
9077|025|U|causes lung disease, cancer, and heart disease. Stopping smoking||
9077|026|U|is one of the most important things you can do to improve your||
9077|027|U|health and live longer.||
9077|028|B|||
9077|029|H|HOW TO USE:  If you are using the over-the-counter product, read||
9077|030|H|all directions on the product package before using this||
9077|031|H|medication. If your doctor has prescribed this medication, read||
9077|032|H|the Patient Information Leaflet if available from your pharmacist||
9077|033|H|before you start using this product and each time you get a||
9077|034|H|refill. Make sure you understand how to apply a new patch and||
9077|035|H|dispose of the used product. If you have any questions, ask your||
9077|036|H|doctor or pharmacist.||
9077|037|H|   Start this medication on your quit (smoking) day. The patch||
9077|038|H|should be applied to a clean, dry, non-hairy area on the trunk or||
9077|039|H|upper arm. Check the manufacturer's instruction sheet for||
9077|040|H|recommended areas to place the patch. If necessary, clip hair||
9077|041|H|from the site before applying the patch. Do not shave the area.||
9077|042|H|Remove the patch from the package, peel off the protective strip,||
9077|043|H|and immediately apply the patch to the skin. Press firmly for 10||
9077|044|H|to 20 seconds to make sure the patch stays in place. Be sure the||
9077|045|H|edges are held firmly to the skin. Wash your hands with plain||
9077|046|H|water after applying the patch. Do not use soap.||
9077|047|H|   The best dose for you is the dose that decreases the urge to||
9077|048|H|smoke without side effects from too much nicotine. If your doctor||
9077|049|H|has prescribed this medication, follow your doctor's orders||
9077|050|H|carefully. Your dose will need to be adjusted to your needs,||
9077|051|H|including smoking history and medical condition.||
9077|052|H|   Different brands of nicotine patches have different amounts of||
9077|053|H|nicotine and different instructions for how long to leave the||
9077|054|H|patch on the skin (such as for 24 hours or only while awake).||
9077|055|H|Consult your doctor or pharmacist about which brand of patch to||
9077|056|H|use. If you wake up craving cigarettes, the 24-hour patch may be||
9077|057|H|best. If the patch causes vivid dreams or interferes with sleep,||
9077|058|H|you may need to wear the patch only while awake (16 hours each||
9077|059|H|day).||
9077|060|H|   Do not apply the patch to red/cut/irritated skin or over other||
9077|061|H|skin products (such as makeup, lotions, powders). Do not use the||
9077|062|H|patch if the individual pouch is open or damaged or if the patch||
9077|063|H|is cut, torn, or damaged. Apply the patch to a different area on||
9077|064|H|your body each time to avoid irritation. Wait at least a week||
9077|065|H|before using the same application site. Apply a new patch if your||
9077|066|H|patch falls off.||
9077|067|H|   Do not wear a patch for more than 24 hours. Do not wear more||
9077|068|H|than 1 patch at a time. After removing each patch, fold it in||
9077|069|H|half so it sticks to itself, and discard in the trash away from||
9077|070|H|children and pets.||
9077|071|H|   Use a new patch each day, applying it at the same time each||
9077|072|H|day to help you remember, usually when you wake up. After several||
9077|073|H|weeks, you will gradually lower your dose (strength of patch)||
9077|074|H|until you no longer need nicotine replacement. It is important to||
9077|075|H|complete the treatment with this medication (8 to 10 weeks). If||
9077|076|H|after the treatment period, you still feel the need to use this||
9077|077|H|medication to prevent you from smoking, talk to your doctor.||
9077|078|H|   If you suddenly stop using this medication, you may have||
9077|079|H|withdrawal symptoms (such as tobacco cravings, nervousness,||
9077|080|H|irritability, headache). To help prevent withdrawal, your doctor||
9077|081|H|may lower your dose slowly. Withdrawal is more likely if you have||
9077|082|H|used nicotine for a long time or in high doses. Tell your doctor||
9077|083|H|or pharmacist right away if you have withdrawal.||
9077|084|H|   Tell your doctor if you have not been able to quit smoking||
9077|085|H|after using this product for 4 weeks. Some smokers are||
9077|086|H|unsuccessful the first time they try to quit. You may need to||
9077|087|H|stop using this product and try again later. Many people who||
9077|088|H|cannot quit the first time are successful the next time.||
9077|089|B|||
9077|090|S|SIDE EFFECTS:  Mild itching, redness, burning, and stinging at||
9077|091|S|the application site may occur. Stop using this product and tell||
9077|092|S|your doctor if redness caused by the patch does not go away after||
9077|093|S|4 days. Nausea, dizziness, flushing, heartburn, or headache may||
9077|094|S|also occur. Common nicotine withdrawal symptoms can occur when||
9077|095|S|you stop smoking and include dizziness, anxiety, depression, or||
9077|096|S|trouble sleeping, among others. If any of these withdrawal||
9077|097|S|symptoms or side effects last or get worse, tell your doctor or||
9077|098|S|pharmacist promptly.||
9077|099|S|   If your doctor has directed you to use this medication,||
9077|100|S|remember that your doctor has judged that the benefit to you is||
9077|101|S|greater than the risk of side effects. Many people using this||
9077|102|S|medication do not have serious side effects. Serious side effects||
9077|103|S|are more likely if you continue to smoke while using this||
9077|104|S|product.||
9077|105|S|   Stop using this medication and tell your doctor right away if||
9077|106|S|you have any serious side effects, including: mental/mood changes||
9077|107|S|(such as irritability, trouble sleeping, vivid dreams),||
9077|108|S|numbness/tingling in hands/feet, swelling hands/ankles/feet.||
9077|109|S|   Stop using this medication and get medical help right away if||
9077|110|S|you have any very serious side effects, including: chest pain,||
9077|111|S|confusion, severe headache, fast/irregular/pounding heartbeat,||
9077|112|S|trouble speaking, weakness on one side of the body.||
9077|113|S|   A very serious allergic reaction to this drug is rare.||
9077|114|S|However, get medical help right away if you notice any symptoms||
9077|115|S|of a serious allergic reaction, including: rash, itching/swelling||
9077|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9077|117|S|breathing.||
9077|118|S|   This is not a complete list of possible side effects. If you||
9077|119|S|notice other effects not listed above, contact your doctor or||
9077|120|S|pharmacist.||
9077|121|S|   In the US -||
9077|122|S|   Call your doctor for medical advice about side effects. You||
9077|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9077|124|S|www.fda.gov/medwatch.||
9077|125|S|   In Canada - Call your doctor for medical advice about side||
9077|126|S|effects. You may report side effects to Health Canada at||
9077|127|S|1-866-234-2345.||
9077|128|B|||
9077|129|P|PRECAUTIONS:  Before using this product, tell your doctor or||
9077|130|P|pharmacist if you are allergic to nicotine; or to adhesive tape;||
9077|131|P|or if you have any other allergies. This product may contain||
9077|132|P|inactive ingredients, which can cause allergic reactions or other||
9077|133|P|problems. Talk to your pharmacist for more details.||
9077|134|P|   Before using this medication, tell your doctor or pharmacist||
9077|135|P|your medical history, especially of: blood vessel disease (such||
9077|136|P|as Raynaud's disease, stroke), diabetes, heart disease (such as||
9077|137|P|chest pain, heart attack, irregular heartbeat), high blood||
9077|138|P|pressure, liver disease, kidney disease, esophagus problems (such||
9077|139|P|as esophagitis), stomach/intestinal sores (peptic ulcers), a||
9077|140|P|certain adrenal gland tumor (pheochromocytoma), overactive||
9077|141|P|thyroid (hyperthyroidism), seizures, skin problems (such as||
9077|142|P|eczema, contact dermatitis).||
9077|143|P|   Before having surgery, tell your doctor or dentist about all||
9077|144|P|the products you use (including prescription drugs,||
9077|145|P|nonprescription drugs, and herbal products).||
9077|146|P|   If you are going to have an MRI test, tell testing personnel||
9077|147|P|that you are using this patch. Some patches may contain metals||
9077|148|P|that can cause serious burns during an MRI. Ask your doctor||
9077|149|P|whether you will need to remove your patch before the test and||
9077|150|P|apply a new patch afterward, and how to do so properly.||
9077|151|P|   Strenuous exercise may raise your skin temperature and||
9077|152|P|increase the amount of nicotine absorbed through the skin. Talk||
9077|153|P|with your doctor about the effects of exercise on this||
9077|154|P|medication.||
9077|155|P|   Avoid exposing the skin under the patch to direct heat sources||
9077|156|P|such as heating pads, electric blankets, heat lamps, saunas, hot||
9077|157|P|tubs, heated water beds, or prolonged direct sunlight while||
9077|158|P|wearing your patch. Heat sources may cause more drug to be||
9077|159|P|released into your body, increasing the chance of side effects.||
9077|160|P|   Nicotine and smoking may harm an unborn baby. If you are||
9077|161|P|pregnant, try to stop smoking without using a nicotine||
9077|162|P|replacement product if possible. During pregnancy, this||
9077|163|P|medication should be used only when clearly needed. Discuss the||
9077|164|P|risks and benefits with your doctor.||
9077|165|P|   Nicotine from smoking and from this medication passes into||
9077|166|P|breast milk and could have undesirable effects on a nursing||
9077|167|P|infant. Smoking near an infant can also harm the infant. Consult||
9077|168|P|your doctor before breastfeeding.||
9077|169|B|||
9077|170|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9077|171|I|medications work or increase your risk for serious side effects.||
9077|172|I|This document does not contain all possible drug interactions.||
9077|173|I|Keep a list of all the products you use (including||
9077|174|I|prescription/nonprescription drugs and herbal products) and share||
9077|175|I|it with your doctor and pharmacist. Do not start, stop, or change||
9077|176|I|the dosage of any medicines without your doctor's approval.||
9077|177|I|   Stopping smoking can change the way the liver removes certain||
9077|178|I|drugs from the body (including acetaminophen, caffeine, insulin,||
9077|179|I|oxazepam, pentazocine, propoxyphene, propranolol, theophylline,||
9077|180|I|tricyclic antidepressants such as amitriptyline/imipramine,||
9077|181|I|"water pills"/diuretics such as furosemide). Tell all your||
9077|182|I|doctors and pharmacists that you are quitting smoking.||
9077|183|B|||
9077|184|O|OVERDOSE:  This medication patch may be harmful if chewed or||
9077|185|O|swallowed. If someone has overdosed, remove the patch if||
9077|186|O|possible. For serious symptoms such as passing out or trouble||
9077|187|O|breathing, call 911. Otherwise, call a poison control center||
9077|188|O|right away. US residents can call 1-800-222-1222. Canada||
9077|189|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9077|190|O|include: confusion, drooling, seizure, slow/shallow breathing,||
9077|191|O|hearing problems.||
9077|192|B|||
9077|193|N|NOTES:  If your doctor has prescribed this medication for you, do||
9077|194|N|not share it with others.||
9077|195|B|||
9077|196|D|MISSED DOSE:  If you forget to change your patch on time, change||
9077|197|D|it as soon as you remember. You can change your next patch 24||
9077|198|D|hours later or go back to your usual dosing schedule. Do not||
9077|199|D|double the dose to catch up.||
9077|200|B|||
9077|201|R|STORAGE:  Store at room temperature. Do not open the pouch until||
9077|202|R|you are ready to use the patch. Keep all medications away from||
9077|203|R|children and pets.||
9077|204|R|   Do not flush medications down the toilet or pour them into a||
9077|205|R|drain unless instructed to do so. Properly discard this product||
9077|206|R|when it is expired or no longer needed (See How to Use section).||
9077|207|B|||
9077|208|A|Information last revised August 2024.||
9077|209|A|Copyright(c) 2025 First Databank, Inc.||
9077|210|B|||
9078|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9078|002|Z|does NOT have all possible information about this product. This||
9078|003|Z|information does not assure that this product is safe, effective,||
9078|004|Z|or appropriate for you. This information is not individual||
9078|005|Z|medical advice and does not substitute for the advice of your||
9078|006|Z|health care professional. Always ask your health care||
9078|007|Z|professional for complete information about this product and your||
9078|008|Z|specific health needs.||
9078|009|B|||
9078|010|T|TRIAMTERENE/HYDROCHLOROTHIAZIDE - ORAL||
9078|011|F|(HYE-droe-KLOR-oh-THYE-a-zide/try-AM-ter-een)||
9078|012|B|||
9078|013|C|COMMON BRAND NAME(S): Dyazide, Maxzide||
9078|014|B|||
9078|015|W|WARNING:  This medication can raise your body's potassium levels.||
9078|016|W|The risk for this is higher for people with diabetes or kidney||
9078|017|W|disease, older adults, or during severe illness. High potassium||
9078|018|W|levels can cause serious (rarely fatal) side effects. Tell your||
9078|019|W|doctor right away if you have any of these serious side effects:||
9078|020|W|muscle weakness, slow/irregular heartbeat.||
9078|021|B|||
9078|022|U|USES:  This drug is used to treat high blood pressure. Lowering||
9078|023|U|high blood pressure helps prevent strokes, heart attacks, and||
9078|024|U|kidney problems. This medication is a combination of two "water||
9078|025|U|pills" (diuretics): triamterene and hydrochlorothiazide. This||
9078|026|U|combination is used by people who have developed or are at risk||
9078|027|U|for having low potassium levels on hydrochlorothiazide. It causes||
9078|028|U|you to make more urine, which helps your body get rid of extra||
9078|029|U|salt and water.||
9078|030|U|   This medication also reduces extra fluid in the body (edema)||
9078|031|U|caused by conditions such as heart failure, liver disease, or||
9078|032|U|kidney disease. This can lessen symptoms such as shortness of||
9078|033|U|breath or swelling in your ankles or feet.||
9078|034|B|||
9078|035|H|HOW TO USE:  Take this medication by mouth with or without food||
9078|036|H|as directed by your doctor, usually once daily in the morning. It||
9078|037|H|is best to avoid taking this medication within 4 hours of your||
9078|038|H|bedtime to prevent having to get up to urinate.||
9078|039|H|   If you also take certain drugs to lower your cholesterol (bile||
9078|040|H|acid-binding resins such as cholestyramine or colestipol), take||
9078|041|H|this product at least 4 hours before or at least 4 to 6 hours||
9078|042|H|after these medications.||
9078|043|H|   The dosage is based on your medical condition and response to||
9078|044|H|treatment.||
9078|045|H|   Use this medication regularly to get the most benefit from it.||
9078|046|H|To help you remember, take it at the same time each day. Keep||
9078|047|H|taking this medication even if you feel well. Most people with||
9078|048|H|high blood pressure do not feel sick.||
9078|049|H|   Tell your doctor if your condition does not get better or if||
9078|050|H|it gets worse (for example, your blood pressure readings remain||
9078|051|H|high or increase).||
9078|052|B|||
9078|053|S|SIDE EFFECTS:  See also Warning section.||
9078|054|S|   Dizziness, lightheadedness, headache, or upset stomach may||
9078|055|S|occur as your body adjusts to the medication. If any of these||
9078|056|S|effects last or get worse, tell your doctor or pharmacist||
9078|057|S|promptly.||
9078|058|S|   To reduce the risk of dizziness and lightheadedness, get up||
9078|059|S|slowly when rising from a sitting or lying position.||
9078|060|S|   Remember that this medication has been prescribed because your||
9078|061|S|doctor has judged that the benefit to you is greater than the||
9078|062|S|risk of side effects. Many people using this medication do not||
9078|063|S|have serious side effects.||
9078|064|S|   This product may cause dehydration and electrolyte imbalance.||
9078|065|S|Tell your doctor right away if you have any symptoms of||
9078|066|S|dehydration or electrolyte imbalance, including unusual dry||
9078|067|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
9078|068|S|heartbeat, or confusion.||
9078|069|S|   Tell your doctor right away if you have any serious side||
9078|070|S|effects, including: fainting, decrease in vision, eye pain, joint||
9078|071|S|pain (such as big toe pain), signs of kidney problems (such as||
9078|072|S|change in the amount of urine).||
9078|073|S|   A very serious allergic reaction to this drug is rare.||
9078|074|S|However, get medical help right away if you notice any symptoms||
9078|075|S|of a serious allergic reaction, including: rash, itching/swelling||
9078|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9078|077|S|breathing.||
9078|078|S|   This is not a complete list of possible side effects. If you||
9078|079|S|notice other effects not listed above, contact your doctor or||
9078|080|S|pharmacist.||
9078|081|S|   In the US -||
9078|082|S|   Call your doctor for medical advice about side effects. You||
9078|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9078|084|S|www.fda.gov/medwatch.||
9078|085|S|   In Canada - Call your doctor for medical advice about side||
9078|086|S|effects. You may report side effects to Health Canada at||
9078|087|S|1-866-234-2345.||
9078|088|B|||
9078|089|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9078|090|P|pharmacist if you are allergic to triamterene or||
9078|091|P|hydrochlorothiazide; or if you have any other allergies. This||
9078|092|P|product may contain inactive ingredients, which can cause||
9078|093|P|allergic reactions or other problems. Talk to your pharmacist for||
9078|094|P|more details.||
9078|095|P|   Before using this medication, tell your doctor or pharmacist||
9078|096|P|your medical history, especially of: diabetes, gout, high level||
9078|097|P|of potassium in the blood, kidney disease (including kidney||
9078|098|P|stones), liver disease, lupus, skin cancer.||
9078|099|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9078|100|P|can make you more dizzy. Do not drive, use machinery, or do||
9078|101|P|anything that needs alertness until you can do it safely. Limit||
9078|102|P|alcoholic beverages. Talk to your doctor if you are using||
9078|103|P|marijuana (cannabis).||
9078|104|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
9078|105|P|and cause you to feel lightheaded. Tell your doctor if you have||
9078|106|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
9078|107|P|of fluids unless your doctor tells you not to.||
9078|108|P|   If you have diabetes, this product may affect your blood||
9078|109|P|sugar. Check your blood sugar regularly as directed and share the||
9078|110|P|results with your doctor. Your doctor may need to adjust your||
9078|111|P|diabetes medication, exercise program, or diet.||
9078|112|P|   This medication may affect your potassium levels. Before using||
9078|113|P|potassium supplements or salt substitutes that contain potassium,||
9078|114|P|consult your doctor or pharmacist.||
9078|115|P|   This medication may make you more sensitive to the sun. It may||
9078|116|P|also increase your risk for skin cancer, especially if you take||
9078|117|P|it for a long time. Limit your time in the sun. Avoid tanning||
9078|118|P|booths and sunlamps. Use sunscreen and wear protective clothing||
9078|119|P|when outdoors. Tell your doctor right away if you get sunburned,||
9078|120|P|have skin blisters/redness, or notice new or changed moles/skin||
9078|121|P|lesions.||
9078|122|P|   Before having surgery, tell your doctor or dentist about all||
9078|123|P|the products you use (including prescription drugs,||
9078|124|P|nonprescription drugs, and herbal products).||
9078|125|P|   Older adults may be more sensitive to the effects of this||
9078|126|P|drug, especially dizziness, or high blood potassium levels.||
9078|127|P|   During pregnancy, this medication should be used only when||
9078|128|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
9078|129|P|benefits with your doctor.||
9078|130|P|   It is unknown if triamterene passes into breast milk.||
9078|131|P|Hydrochlorothiazide passes into breast milk, but is unlikely to||
9078|132|P|harm a nursing infant. Consult your doctor before breastfeeding.||
9078|133|B|||
9078|134|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
9078|135|I|   Drug interactions may change how your medications work or||
9078|136|I|increase your risk for serious side effects. This document does||
9078|137|I|not contain all possible drug interactions. Keep a list of all||
9078|138|I|the products you use (including prescription/nonprescription||
9078|139|I|drugs and herbal products) and share it with your doctor and||
9078|140|I|pharmacist. Do not start, stop, or change the dosage of any||
9078|141|I|medicines without your doctor's approval.||
9078|142|I|   Some products that may interact with this drug include:||
9078|143|I|dofetilide, lithium, other drugs that may increase potassium||
9078|144|I|levels (such as spironolactone, amiloride, cyclosporine).||
9078|145|I|   Some products have ingredients that could raise your blood||
9078|146|I|pressure or worsen your swelling. Tell your pharmacist what||
9078|147|I|products you are using, and ask how to use them safely||
9078|148|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
9078|149|I|ibuprofen/naproxen).||
9078|150|I|   This medication may interfere with certain lab tests (such as||
9078|151|I|parathyroid function), possibly causing false test results. Make||
9078|152|I|sure lab personnel and all your doctors know you use this drug.||
9078|153|B|||
9078|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9078|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9078|156|O|poison control center right away. US residents can call||
9078|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9078|158|O|Symptoms of overdose may include: severe dizziness, fainting.||
9078|159|B|||
9078|160|N|NOTES:  Do not share this medication with others.||
9078|161|N|   Lifestyle changes such as stress reduction programs, exercise,||
9078|162|N|and dietary changes may increase the effectiveness of this||
9078|163|N|medicine. Talk to your doctor or pharmacist about lifestyle||
9078|164|N|changes that might benefit you.||
9078|165|N|   Lab and/or medical tests (such as kidney function, potassium||
9078|166|N|levels, skin exams, cholesterol levels) should be done while you||
9078|167|N|are taking this medication. Keep all medical and lab||
9078|168|N|appointments. Consult your doctor for more details.||
9078|169|N|   Check your blood pressure regularly while taking this||
9078|170|N|medication. Learn how to monitor your own blood pressure, and||
9078|171|N|share the results with your doctor.||
9078|172|B|||
9078|173|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9078|174|D|remember. If it is near the time of the next dose, skip the||
9078|175|D|missed dose. Take your next dose at the regular time. Do not||
9078|176|D|double the dose to catch up.||
9078|177|B|||
9078|178|R|STORAGE:  Store at room temperature away from light and moisture.||
9078|179|R|Do not store in the bathroom. Keep all medications away from||
9078|180|R|children and pets.||
9078|181|R|   Do not flush medications down the toilet or pour them into a||
9078|182|R|drain unless instructed to do so. Properly discard this product||
9078|183|R|when it is expired or no longer needed. Consult your pharmacist||
9078|184|R|or local waste disposal company.||
9078|185|B|||
9078|186|A|Information last revised March 2025.||
9078|187|A|Copyright(c) 2025 First Databank, Inc.||
9078|188|B|||
9079|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9079|002|Z|does NOT have all possible information about this product. This||
9079|003|Z|information does not assure that this product is safe, effective,||
9079|004|Z|or appropriate for you. This information is not individual||
9079|005|Z|medical advice and does not substitute for the advice of your||
9079|006|Z|health care professional. Always ask your health care||
9079|007|Z|professional for complete information about this product and your||
9079|008|Z|specific health needs.||
9079|009|B|||
9079|010|T|BENZTROPINE - INJECTION||
9079|011|F|(BENZ-troe-peen)||
9079|012|B|||
9079|013|C|COMMON BRAND NAME(S): Cogentin||
9079|014|B|||
9079|015|U|USES:  Benztropine is used to treat symptoms of Parkinson's||
9079|016|U|disease or involuntary movements due to the side effects of||
9079|017|U|certain psychiatric drugs (antipsychotics such as||
9079|018|U|chlorpromazine/haloperidol). Benztropine belongs to a class of||
9079|019|U|medication called anticholinergics that work by blocking a||
9079|020|U|certain natural substance (acetylcholine). This helps decrease||
9079|021|U|muscle stiffness, sweating, and the production of saliva, and||
9079|022|U|helps improve walking ability in people with Parkinson's disease.||
9079|023|U|   Anticholinergics can stop severe muscle spasms of the back,||
9079|024|U|neck, and eyes that are sometimes caused by psychiatric drugs. It||
9079|025|U|can also decrease other side effects such as muscle||
9079|026|U|stiffness/rigidity (extrapyramidal signs-EPS). It is not helpful||
9079|027|U|in treating movement problems caused by tardive dyskinesia and||
9079|028|U|may worsen them. Benztropine should not be used by children||
9079|029|U|younger than 3 years.||
9079|030|B|||
9079|031|H|HOW TO USE:  If you are using this medication at home, learn all||
9079|032|H|preparation and usage instructions from your health care||
9079|033|H|professional.||
9079|034|H|   Before using, check this product for particles or||
9079|035|H|discoloration. If either is present, do not use the liquid.||
9079|036|H|   This medication is given by injection into a vein or into a||
9079|037|H|muscle, as directed by your doctor, usually 2 to 4 times a day or||
9079|038|H|as a single dose at bedtime.||
9079|039|H|   Learn how to store and discard medical supplies safely.||
9079|040|H|   To reduce your risk of side effects, your doctor may direct||
9079|041|H|you to start this medication at a low dose and gradually increase||
9079|042|H|your dose. Follow your doctor's instructions carefully. The||
9079|043|H|dosage is based on your medical condition, age, and response to||
9079|044|H|treatment.||
9079|045|H|   Use this medication regularly to get the most benefit from it.||
9079|046|H|To help you remember, use it at the same time(s) each day.||
9079|047|H|   If you are using this medication for side effects from another||
9079|048|H|medication, your doctor may instruct you to use it on a regular||
9079|049|H|schedule or only as needed. If you are using this medication for||
9079|050|H|Parkinson's disease, your doctor may change the dose of your||
9079|051|H|other medications (such as levodopa). Follow your doctor's||
9079|052|H|instructions closely.||
9079|053|H|   When this medication is used for a long time, it may not work||
9079|054|H|as well. Talk with your doctor if this medication stops working||
9079|055|H|well.||
9079|056|H|   Though it helps many people, this medication may sometimes||
9079|057|H|cause addiction. This risk may be higher if you have a substance||
9079|058|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
9079|059|H|Take this medication exactly as prescribed to lower the risk of||
9079|060|H|addiction. Ask your doctor or pharmacist for more details.||
9079|061|H|   Do not increase your dose, use it more often, or use it for a||
9079|062|H|longer time than prescribed. Properly stop the medication when so||
9079|063|H|directed. Some conditions may become worse when the drug is||
9079|064|H|suddenly stopped. Your dose may need to be gradually decreased.||
9079|065|H|   It may take 2-3 days before the benefit of this drug takes||
9079|066|H|effect. Tell your doctor if your condition lasts or gets worse.||
9079|067|B|||
9079|068|S|SIDE EFFECTS:  Drowsiness, dizziness, constipation, flushing,||
9079|069|S|nausea, nervousness, blurred vision, or dry mouth may occur as||
9079|070|S|your body adjusts to the medication. If any of these effects last||
9079|071|S|or get worse, tell your doctor or pharmacist promptly.||
9079|072|S|   To reduce the risk of dizziness and lightheadedness, get up||
9079|073|S|slowly when rising from a sitting or lying position.||
9079|074|S|   To relieve dry mouth, suck (sugarless) hard candy or ice||
9079|075|S|chips, chew (sugarless) gum, drink water, or use a saliva||
9079|076|S|substitute.||
9079|077|S|   Remember that this medication has been prescribed because your||
9079|078|S|doctor has judged that the benefit to you is greater than the||
9079|079|S|risk of side effects. Many people using this medication do not||
9079|080|S|have serious side effects.||
9079|081|S|   Tell your doctor right away if you have any serious side||
9079|082|S|effects, including: high fever, decreased sexual ability, severe||
9079|083|S|stomach/abdominal pain, difficult/painful swallowing, difficulty||
9079|084|S|urinating, weakness.||
9079|085|S|   Get medical help right away if you have any very serious side||
9079|086|S|effects, including: chest pain, severe dizziness/fainting,||
9079|087|S|fast/irregular/slow heartbeat, mental/mood changes (such as||
9079|088|S|confusion, hallucinations, memory problems), eye||
9079|089|S|pain/swelling/redness, vision changes (such as seeing rainbows||
9079|090|S|around lights at night).||
9079|091|S|   A very serious allergic reaction to this drug is rare.||
9079|092|S|However, get medical help right away if you notice any symptoms||
9079|093|S|of a serious allergic reaction, including: rash, itching/swelling||
9079|094|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9079|095|S|breathing.||
9079|096|S|   This is not a complete list of possible side effects. If you||
9079|097|S|notice other effects not listed above, contact your doctor or||
9079|098|S|pharmacist.||
9079|099|S|   In the US -||
9079|100|S|   Call your doctor for medical advice about side effects. You||
9079|101|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9079|102|S|www.fda.gov/medwatch.||
9079|103|S|   In Canada - Call your doctor for medical advice about side||
9079|104|S|effects. You may report side effects to Health Canada at||
9079|105|S|1-866-234-2345.||
9079|106|B|||
9079|107|P|PRECAUTIONS:  Before using benztropine, tell your doctor or||
9079|108|P|pharmacist if you are allergic to it; or if you have any other||
9079|109|P|allergies. This product may contain inactive ingredients, which||
9079|110|P|can cause allergic reactions or other problems. Talk to your||
9079|111|P|pharmacist for more details.||
9079|112|P|   Before using this medication, tell your doctor or pharmacist||
9079|113|P|your medical history, especially of: personal or family history||
9079|114|P|of glaucoma (angle-closure type), breathing problems (such as||
9079|115|P|asthma, emphysema), diarrhea caused by an infection, heart||
9079|116|P|problems (such as angina, heart attack, heart failure,||
9079|117|P|fast/irregular heartbeat), high/low blood pressure, intestinal||
9079|118|P|problems (such as chronic constipation, ileus, ulcerative||
9079|119|P|colitis, bowel obstruction), blockage of the||
9079|120|P|bladder/esophagus/stomach/intestines, kidney disease, liver||
9079|121|P|disease, mental/mood problems (such as anxiety, dementia,||
9079|122|P|psychosis), a certain muscle disease (myasthenia gravis), a||
9079|123|P|certain nerve disease (autonomic neuropathy), seizure, stomach||
9079|124|P|problems (such as acid reflux, hiatal hernia, ulcer), stroke,||
9079|125|P|overactive thyroid (hyperthyroidism), problems urinating (for||
9079|126|P|example, due to enlarged prostate, neurogenic bladder), personal||
9079|127|P|or family history of a substance use disorder (such as overuse of||
9079|128|P|or addiction to drugs/alcohol).||
9079|129|P|   This drug may make you dizzy or drowsy or blur your vision.||
9079|130|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9079|131|P|drowsy. Do not drive, use machinery, or do anything that needs||
9079|132|P|alertness or clear vision until you can do it safely. Avoid||
9079|133|P|alcoholic beverages. Talk to your doctor if you are using||
9079|134|P|marijuana (cannabis).||
9079|135|P|   This medication decreases saliva production, an effect that||
9079|136|P|can increase gum and tooth problems (such as cavities, gum||
9079|137|P|disease). Take special care with your dental hygiene (such as||
9079|138|P|brushing, flossing) and have regular dental check-ups.||
9079|139|P|   Benztropine may make you sweat less, making you more likely to||
9079|140|P|get heat stroke. Avoid doing things that may cause you to||
9079|141|P|overheat, such as hard work or exercise in hot weather, or using||
9079|142|P|hot tubs. When the weather is hot, drink a lot of fluids and||
9079|143|P|dress lightly. If you overheat, quickly look for a place to cool||
9079|144|P|down and rest. Get medical help right away if you have a fever||
9079|145|P|that does not go away, mental/mood changes, headache, or||
9079|146|P|dizziness.||
9079|147|P|   Older adults may be more sensitive to the side effects of this||
9079|148|P|drug, especially dizziness, drowsiness, heat stroke, memory||
9079|149|P|problems, difficulty urinating, and constipation. Dizziness and||
9079|150|P|drowsiness can increase the risk of falling.||
9079|151|P|   Children may be more sensitive to the side effects of this||
9079|152|P|drug, especially effects on heart rate.||
9079|153|P|   During pregnancy, this medication should be used only when||
9079|154|P|clearly needed. Discuss the risks and benefits with your doctor.||
9079|155|P|   It is unknown if this medication passes into breast milk.||
9079|156|P|Consult your doctor before breastfeeding.||
9079|157|B|||
9079|158|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9079|159|I|medications work or increase your risk for serious side effects.||
9079|160|I|This document does not contain all possible drug interactions.||
9079|161|I|Keep a list of all the products you use (including||
9079|162|I|prescription/nonprescription drugs and herbal products) and share||
9079|163|I|it with your doctor and pharmacist. Do not start, stop, or change||
9079|164|I|the dosage of any medicines without your doctor's approval.||
9079|165|I|   Some products that may interact with this drug are: potassium||
9079|166|I|tablets/capsules, pramlintide.||
9079|167|I|   Tell your doctor or pharmacist if you are taking other||
9079|168|I|products that cause drowsiness such as opioid pain or cough||
9079|169|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9079|170|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9079|171|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9079|172|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
9079|173|I|diphenhydramine).||
9079|174|I|   Check the labels on all your medicines (such as allergy or||
9079|175|I|cough-and-cold products) because they may contain ingredients||
9079|176|I|that cause drowsiness. Ask your pharmacist about using those||
9079|177|I|products safely.||
9079|178|I|   This medication may interfere with certain medical/lab tests||
9079|179|I|(including brain scan for Parkinson's disease), possibly causing||
9079|180|I|false test results. Make sure lab personnel and all your doctors||
9079|181|I|know you use this drug.||
9079|182|B|||
9079|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9079|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9079|185|O|poison control center right away. US residents can call||
9079|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9079|187|O|Symptoms of overdose may include: unusually fast/slow heartbeat,||
9079|188|O|slow/shallow breathing, unconsciousness, seizures, loss of||
9079|189|O|coordination, fever, hot/dry/flushed skin, widened pupils, change||
9079|190|O|in vision, change in the amount of urine, confusion,||
9079|191|O|hallucinations.||
9079|192|B|||
9079|193|N|NOTES:  Do not share this medication with others.||
9079|194|N|   Lab and/or medical tests (such as eye exams) should be done||
9079|195|N|while you are using this medication. Keep all medical and lab||
9079|196|N|appointments. Consult your doctor for more details.||
9079|197|B|||
9079|198|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9079|199|D|If it is near the time of the next dose, skip the missed dose.||
9079|200|D|Use your next dose at the regular time. Do not double the dose to||
9079|201|D|catch up.||
9079|202|B|||
9079|203|R|STORAGE:  Store at room temperature. Keep the medication in the||
9079|204|R|original carton to protect from light. Keep all medications away||
9079|205|R|from children and pets.||
9079|206|R|   Do not flush medications down the toilet or pour them into a||
9079|207|R|drain unless instructed to do so. Properly discard this product||
9079|208|R|when it is expired or no longer needed. Consult your pharmacist||
9079|209|R|or local waste disposal company.||
9079|210|B|||
9079|211|A|Information last revised October 2025.||
9079|212|A|Copyright(c) 2025 First Databank, Inc.||
9079|213|B|||
9080|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9080|002|Z|does NOT have all possible information about this product. This||
9080|003|Z|information does not assure that this product is safe, effective,||
9080|004|Z|or appropriate for you. This information is not individual||
9080|005|Z|medical advice and does not substitute for the advice of your||
9080|006|Z|health care professional. Always ask your health care||
9080|007|Z|professional for complete information about this product and your||
9080|008|Z|specific health needs.||
9080|009|B|||
9080|010|T|DEXTROAMPHETAMINE - ORAL||
9080|011|F|(DEX-troe-am-FET-a-meen)||
9080|012|B|||
9080|013|C|COMMON BRAND NAME(S): Dexedrine||
9080|014|B|||
9080|015|W|WARNING:  Misuse or abuse of amphetamines may cause serious||
9080|016|W|(possibly fatal) heart and blood pressure problems.||
9080|017|W|Amphetamine-type medications can be habit-forming. Use only as||
9080|018|W|directed. If you use this drug for a long time, you may become||
9080|019|W|dependent on it and may have withdrawal symptoms after stopping||
9080|020|W|the drug. Consult your doctor or pharmacist for more details.||
9080|021|W|(See also How to Use section).||
9080|022|B|||
9080|023|U|USES:  This medication is used to treat attention deficit||
9080|024|U|hyperactivity disorder - ADHD. It works by changing the amounts||
9080|025|U|of certain natural substances in the brain. Dextroamphetamine||
9080|026|U|belongs to a class of drugs known as stimulants. It can help||
9080|027|U|increase your ability to pay attention, stay focused on an||
9080|028|U|activity, and control behavior problems. It may also help you to||
9080|029|U|organize your tasks and improve listening skills.||
9080|030|U|   This medication is also used to treat a certain sleeping||
9080|031|U|disorder (narcolepsy) to help you stay awake during the day. It||
9080|032|U|should not be used to treat tiredness or to hold off sleep in||
9080|033|U|people who do not have a sleep disorder.||
9080|034|B|||
9080|035|H|HOW TO USE:  Read the Medication Guide and, if available, the||
9080|036|H|Patient Information Leaflet provided by your pharmacist before||
9080|037|H|you start taking dextroamphetamine and each time you get a||
9080|038|H|refill. If you have any questions, ask your doctor or pharmacist.||
9080|039|H|   Take this medication with or without food as directed by your||
9080|040|H|doctor, usually 1 to 3 times a day. The first dose is usually||
9080|041|H|taken when you wake up in the morning. If more doses are||
9080|042|H|prescribed, take them as directed by your doctor, usually 4-6||
9080|043|H|hours apart. Taking this medication late in the day may cause||
9080|044|H|trouble sleeping (insomnia).||
9080|045|H|   If you are using the liquid form of this medication, carefully||
9080|046|H|measure the dose using a special measuring device/spoon. Do not||
9080|047|H|use a household spoon because you may not get the correct dose.||
9080|048|H|   The dosage is based on your medical condition and response to||
9080|049|H|treatment. Your doctor may adjust your dose to find the dose that||
9080|050|H|is best for you. Follow your doctor's instructions carefully.||
9080|051|H|   Use this medication regularly to get the most benefit from it.||
9080|052|H|To help you remember, take it at the same time(s) each day.||
9080|053|H|   During treatment, your doctor may occasionally recommend||
9080|054|H|stopping the medication for a short time to see whether there are||
9080|055|H|any changes in your behavior and whether the medication is still||
9080|056|H|needed.||
9080|057|H|   If you suddenly stop using this medication, you may have||
9080|058|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
9080|059|H|mental/mood changes such as depression). To help prevent||
9080|060|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
9080|061|H|more likely if you have used dextroamphetamine for a long time or||
9080|062|H|in high doses. Tell your doctor or pharmacist right away if you||
9080|063|H|have withdrawal.||
9080|064|H|   Though it helps many people, this medication may sometimes||
9080|065|H|cause addiction. This risk may be higher if you have a substance||
9080|066|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
9080|067|H|Do not increase your dose, take it more often, or use it for a||
9080|068|H|longer time than prescribed. Properly stop the medication when so||
9080|069|H|directed.||
9080|070|H|   When this medication is used for a long time, it may not work||
9080|071|H|as well. Talk with your doctor if this medication stops working||
9080|072|H|well.||
9080|073|H|   Tell your doctor if your condition does not get better or if||
9080|074|H|it gets worse.||
9080|075|B|||
9080|076|S|SIDE EFFECTS:  Nausea, stomach upset, cramps, loss of appetite,||
9080|077|S|diarrhea, dry mouth, headache, nervousness, dizziness, trouble||
9080|078|S|sleeping, sweating, weight loss, irritability, and restlessness||
9080|079|S|may occur. If any of these effects last or get worse, tell your||
9080|080|S|doctor or pharmacist promptly.||
9080|081|S|   Remember that this medication has been prescribed because your||
9080|082|S|doctor has judged that the benefit to you is greater than the||
9080|083|S|risk of side effects. Many people using this medication do not||
9080|084|S|have serious side effects.||
9080|085|S|   This medication may raise your blood pressure. Check your||
9080|086|S|blood pressure regularly and tell your doctor if the results are||
9080|087|S|high.||
9080|088|S|   Tell your doctor right away if you have any serious side||
9080|089|S|effects, including: signs of blood flow problems in the fingers||
9080|090|S|or toes (such as coldness, numbness, pain, or skin color||
9080|091|S|changes), unusual wounds on the fingers or toes,||
9080|092|S|mental/mood/behavior changes (such as agitation, aggression, mood||
9080|093|S|swings, depression, hallucinations, abnormal thoughts/behavior,||
9080|094|S|thoughts of suicide), uncontrolled movements, muscle||
9080|095|S|twitching/shaking, outbursts of words/sounds, change in sexual||
9080|096|S|ability/interest, swelling ankles/feet, extreme tiredness,||
9080|097|S|significant unexplained weight loss, frequent/prolonged erections||
9080|098|S|(in males).||
9080|099|S|   Get medical help right away if you have any very serious side||
9080|100|S|effects, including: shortness of breath, chest/jaw/left arm pain,||
9080|101|S|severe headache, fainting, fast/pounding/irregular heartbeat,||
9080|102|S|seizures, weakness on one side of the body, trouble speaking,||
9080|103|S|confusion, blurred vision.||
9080|104|S|   This medication may increase serotonin and rarely cause a very||
9080|105|S|serious condition called serotonin syndrome/toxicity. The risk||
9080|106|S|increases if you are also taking other drugs that increase||
9080|107|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
9080|108|S|take (see Drug Interactions section). Get medical help right away||
9080|109|S|if you develop some of the following symptoms: fast heartbeat,||
9080|110|S|hallucinations, loss of coordination, severe dizziness, severe||
9080|111|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
9080|112|S|unusual agitation/restlessness.||
9080|113|S|   A very serious allergic reaction to this drug is rare.||
9080|114|S|However, get medical help right away if you notice any symptoms||
9080|115|S|of a serious allergic reaction, including: rash, itching/swelling||
9080|116|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9080|117|S|breathing.||
9080|118|S|   This is not a complete list of possible side effects. If you||
9080|119|S|notice other effects not listed above, contact your doctor or||
9080|120|S|pharmacist.||
9080|121|S|   In the US -||
9080|122|S|   Call your doctor for medical advice about side effects. You||
9080|123|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9080|124|S|www.fda.gov/medwatch.||
9080|125|S|   In Canada - Call your doctor for medical advice about side||
9080|126|S|effects. You may report side effects to Health Canada at||
9080|127|S|1-866-234-2345.||
9080|128|B|||
9080|129|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9080|130|P|pharmacist if you are allergic to it; or to other sympathomimetic||
9080|131|P|drugs (such as amphetamine or lisdexamfetamine); or if you have||
9080|132|P|any other allergies. This product may contain inactive||
9080|133|P|ingredients, which can cause allergic reactions or other||
9080|134|P|problems. Talk to your pharmacist for more details.||
9080|135|P|   Before using this medication, tell your doctor or pharmacist||
9080|136|P|your medical history, especially of: blood circulation problems||
9080|137|P|(such as Raynaud's disease), certain mental/mood conditions (such||
9080|138|P|as severe agitation, psychosis), personal/family history of||
9080|139|P|mental/mood disorders (such as bipolar disorder, depression,||
9080|140|P|psychotic disorder, suicidal thoughts), heart problems (including||
9080|141|P|irregular heartbeat/rhythm, coronary artery disease, heart||
9080|142|P|failure, cardiomyopathy, problems with the heart structure such||
9080|143|P|as valve problems), family history of heart problems (such as||
9080|144|P|sudden death/irregular heartbeat/rhythm), history of stroke, high||
9080|145|P|blood pressure, overactive thyroid (hyperthyroidism), a certain||
9080|146|P|eye problem (glaucoma), seizures, personal or family history of a||
9080|147|P|substance use disorder (such as overuse of or addiction to||
9080|148|P|drugs/alcohol), personal or family history of uncontrolled muscle||
9080|149|P|movements (such as Tourette's syndrome).||
9080|150|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9080|151|P|can make you more dizzy. Do not drive, use machinery, or do||
9080|152|P|anything that needs alertness until you can do it safely. Limit||
9080|153|P|alcoholic beverages. Talk to your doctor if you are using||
9080|154|P|marijuana (cannabis).||
9080|155|P|   Before having surgery, tell your doctor or dentist about all||
9080|156|P|the products you use (including prescription drugs,||
9080|157|P|nonprescription drugs, and herbal products).||
9080|158|P|   Children may be more sensitive to the side effects of this||
9080|159|P|drug, especially weight loss. This medication may slow down a||
9080|160|P|child's growth. The doctor may recommend temporarily stopping the||
9080|161|P|medication from time to time to reduce this risk. Monitor your||
9080|162|P|child's weight and height. Consult your doctor or pharmacist for||
9080|163|P|more details.||
9080|164|P|   Older adults may be more sensitive to the side effects of this||
9080|165|P|drug, especially chest pain, trouble sleeping, or weight loss.||
9080|166|P|   During pregnancy, this medication should be used only when||
9080|167|P|clearly needed. Discuss the risks and benefits with your doctor.||
9080|168|P|Infants born to mothers who are dependent on this medication may||
9080|169|P|be born too soon (premature) and have low birth weight. They may||
9080|170|P|also have withdrawal symptoms. Tell your doctor right away if you||
9080|171|P|notice possible mood changes, agitation, or unusual tiredness in||
9080|172|P|your newborn.||
9080|173|P|   This medication passes into breast milk and may have||
9080|174|P|undesirable effects on a nursing infant. Breastfeeding is not||
9080|175|P|recommended while using this medication. Consult your doctor||
9080|176|P|before breastfeeding.||
9080|177|B|||
9080|178|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9080|179|I|medications work or increase your risk for serious side effects.||
9080|180|I|This document does not contain all possible drug interactions.||
9080|181|I|Keep a list of all the products you use (including||
9080|182|I|prescription/nonprescription drugs and herbal products) and share||
9080|183|I|it with your doctor and pharmacist. Do not start, stop, or change||
9080|184|I|the dosage of any medicines without your doctor's approval.||
9080|185|I|   Taking MAO inhibitors with this medication may cause a serious||
9080|186|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9080|187|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9080|188|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9080|189|I|selegiline, tranylcypromine) during treatment with this||
9080|190|I|medication. Most MAO inhibitors should also not be taken for two||
9080|191|I|weeks before treatment with this medication. Ask your doctor when||
9080|192|I|to start or stop taking this medication.||
9080|193|I|   Some products have ingredients that could raise your heart||
9080|194|I|rate or blood pressure. Tell your pharmacist what products you||
9080|195|I|are using, and ask how to use them safely (especially||
9080|196|I|cough-and-cold products or diet aids).||
9080|197|I|   The risk of serotonin syndrome/toxicity increases if you are||
9080|198|I|also taking other drugs that increase serotonin. Examples include||
9080|199|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
9080|200|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
9080|201|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
9080|202|I|serotonin syndrome/toxicity may be more likely when you start or||
9080|203|I|increase the dose of these drugs.||
9080|204|I|   Dextroamphetamine is very similar to amphetamine or||
9080|205|I|lisdexamfetamine. Do not use medications containing amphetamine||
9080|206|I|or lisdexamfetamine while using dextroamphetamine.||
9080|207|I|   This medication may interfere with certain medical/lab tests||
9080|208|I|(such as blood and urine steroid levels, brain scan for||
9080|209|I|Parkinson's disease), possibly causing false test results. Make||
9080|210|I|sure lab personnel and all your doctors know you use this drug.||
9080|211|B|||
9080|212|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9080|213|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9080|214|O|poison control center right away. US residents can call||
9080|215|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9080|216|O|Symptoms of overdose may include: headache that is severe or||
9080|217|O|doesn't go away, severe mental/mood changes, seizures, severe||
9080|218|O|restlessness, fast breathing.||
9080|219|B|||
9080|220|N|NOTES:  Do not share this medication with others. Sharing it is||
9080|221|N|against the law.||
9080|222|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
9080|223|N|growth monitoring in children) may be done while you are taking||
9080|224|N|this medication. Keep all medical and lab appointments. Consult||
9080|225|N|your doctor for more details.||
9080|226|B|||
9080|227|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
9080|228|D|in the morning hours. If it is late in the afternoon or near the||
9080|229|D|time of the next dose, skip the missed dose. Take your next dose||
9080|230|D|at the regular time. Do not double the dose to catch up.||
9080|231|B|||
9080|232|R|STORAGE:  Store at room temperature away from light and moisture.||
9080|233|R|Do not store in the bathroom. Keep all medications away from||
9080|234|R|children and pets.||
9080|235|R|   Do not flush medications down the toilet or pour them into a||
9080|236|R|drain unless instructed to do so. Properly discard this product||
9080|237|R|when it is expired or no longer needed. Consult your pharmacist||
9080|238|R|or local waste disposal company.||
9080|239|B|||
9080|240|A|Information last revised November 2024.||
9080|241|A|Copyright(c) 2025 First Databank, Inc.||
9080|242|B|||
9083|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9083|002|Z|does NOT have all possible information about this product. This||
9083|003|Z|information does not assure that this product is safe, effective,||
9083|004|Z|or appropriate for you. This information is not individual||
9083|005|Z|medical advice and does not substitute for the advice of your||
9083|006|Z|health care professional. Always ask your health care||
9083|007|Z|professional for complete information about this product and your||
9083|008|Z|specific health needs.||
9083|009|B|||
9083|010|T|CROMOLYN - NASAL||
9083|011|F|(CROW-mow-lin)||
9083|012|B|||
9083|013|C|COMMON BRAND NAME(S): Nasalcrom||
9083|014|B|||
9083|015|U|USES:  This medication is used to prevent allergic symptoms in||
9083|016|U|the nose. It reduces stuffy/runny nose, mucus dripping into the||
9083|017|U|back of the throat, itching, and sneezing caused by seasonal||
9083|018|U|allergies (hay fever) and other allergens (such as dust mites,||
9083|019|U|pet dander). This medication is not an antihistamine and does not||
9083|020|U|provide immediate relief from allergic symptoms. It should be||
9083|021|U|used before contact with the allergen.||
9083|022|U|   Cromolyn is known as a mast cell stabilizer. It works by||
9083|023|U|preventing the release of certain natural substances (histamine,||
9083|024|U|SRS-A) made by the body that cause allergy symptoms.||
9083|025|U|   Do not use this medication to treat sinus infection, asthma,||
9083|026|U|or cold symptoms.||
9083|027|B|||
9083|028|H|HOW TO USE:  Follow all directions on the product package, or use||
9083|029|H|as directed by your doctor. If you have any questions, ask your||
9083|030|H|doctor or pharmacist.||
9083|031|H|   Use 1 spray in each nostril, usually every 4 to 6 hours (3 to||
9083|032|H|4 times a day) or as directed by your doctor. Do not use more||
9083|033|H|than 6 times a day. Use every day you are around allergens (such||
9083|034|H|as during pollen season).||
9083|035|H|   Gently blow your nose before using this drug. If nasal||
9083|036|H|passages are blocked, a nasal decongestant may be used first to||
9083|037|H|open the passages. Use your finger to close the nostril on the||
9083|038|H|side not receiving the medication. While keeping your head||
9083|039|H|upright, place the spray tip into the open nostril. Spray the||
9083|040|H|medication into the open nostril as you breathe in through your||
9083|041|H|nose. Sniff hard a few times to be sure the medication reaches||
9083|042|H|deep into the nose. Repeat these steps for the other nostril.||
9083|043|H|   Avoid spraying the medication into your eyes. Rinse the spray||
9083|044|H|tip with hot water or wipe with a clean tissue after each use.||
9083|045|H|Make sure that water does not get inside the container. Replace||
9083|046|H|cap after each use.||
9083|047|H|   This medication does not work right away. It must be used||
9083|048|H|regularly to be most effective. It may take 1 to 2 weeks of||
9083|049|H|regular use to get the full benefit. If your condition lasts or||
9083|050|H|gets worse after 2 weeks, or if you think you may have a serious||
9083|051|H|medical problem, stop using this medication and get medical help||
9083|052|H|right away. Talk with your doctor if you are still using this||
9083|053|H|medication after 12 weeks.||
9083|054|B|||
9083|055|S|SIDE EFFECTS:  This medication may cause brief stinging/sneezing||
9083|056|S|right after use. If these effects last or get worse, tell your||
9083|057|S|doctor promptly.||
9083|058|S|   If your doctor has directed you to use this medication,||
9083|059|S|remember that your doctor has judged that the benefit to you is||
9083|060|S|greater than the risk of side effects. Many people using this||
9083|061|S|medication do not have serious side effects.||
9083|062|S|   Stop using this medication and tell your doctor right away if||
9083|063|S|you have any serious side effects, including: frequent||
9083|064|S|nosebleeds, sores in the nose, wheezing/chest tightness.||
9083|065|S|   A very serious allergic reaction to this drug is rare.||
9083|066|S|However, get medical help right away if you notice any symptoms||
9083|067|S|of a serious allergic reaction, including: rash, itching/swelling||
9083|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9083|069|S|breathing.||
9083|070|S|   This is not a complete list of possible side effects. If you||
9083|071|S|notice other effects not listed above, contact your doctor or||
9083|072|S|pharmacist.||
9083|073|S|   In the US -||
9083|074|S|   Call your doctor for medical advice about side effects. You||
9083|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9083|076|S|www.fda.gov/medwatch.||
9083|077|S|   In Canada - Call your doctor for medical advice about side||
9083|078|S|effects. You may report side effects to Health Canada at||
9083|079|S|1-866-234-2345.||
9083|080|B|||
9083|081|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
9083|082|P|pharmacist if you are allergic to cromolyn; or if you have any||
9083|083|P|other allergies. This product may contain inactive ingredients||
9083|084|P|(such as preservatives like benzalkonium chloride), which can||
9083|085|P|cause allergic reactions or other problems. Talk to your||
9083|086|P|pharmacist for more details.||
9083|087|P|   If you have any of the following health problems, consult your||
9083|088|P|doctor or pharmacist before using this product: asthma, growths||
9083|089|P|in the nose (nasal polyps).||
9083|090|P|   If you are using this medication for self-treatment, tell your||
9083|091|P|doctor before using this medication if you have any of the||
9083|092|P|following symptoms: fever, yellow/green/discolored fluid from the||
9083|093|P|nose, sinus pain, wheezing.||
9083|094|P|   During pregnancy, this medication should be used only when||
9083|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
9083|096|P|   It is unknown if this drug passes into breast milk. Consult||
9083|097|P|your doctor before breastfeeding.||
9083|098|B|||
9083|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9083|100|I|medications work or increase your risk for serious side effects.||
9083|101|I|This document does not contain all possible drug interactions.||
9083|102|I|Keep a list of all the products you use (including||
9083|103|I|prescription/nonprescription drugs and herbal products) and share||
9083|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
9083|105|I|the dosage of any medicines without your doctor's approval.||
9083|106|B|||
9083|107|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9083|108|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9083|109|O|poison control center right away. US residents can call||
9083|110|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9083|111|B|||
9083|112|N|NOTES:  Do not share this medication with others. Doing so may||
9083|113|N|cause the spread of germs.||
9083|114|N|   Avoid allergens that may be the cause of your allergies. Some||
9083|115|N|common allergens include molds, pollen, grasses, weeds, dust||
9083|116|N|mites, and pet dander. This medication works better if started a||
9083|117|N|week before you expect to be exposed to allergens (such as a week||
9083|118|N|before your seasonal allergy symptoms usually start).||
9083|119|B|||
9083|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9083|121|D|If it is near the time of the next dose, skip the missed dose.||
9083|122|D|Use your next dose at the regular time. Do not double the dose to||
9083|123|D|catch up.||
9083|124|B|||
9083|125|R|STORAGE:  Store at room temperature away from light. Keep all||
9083|126|R|medications away from children and pets.||
9083|127|R|   Do not flush medications down the toilet or pour them into a||
9083|128|R|drain unless instructed to do so. Properly discard this product||
9083|129|R|when it is expired or no longer needed. Consult your pharmacist||
9083|130|R|or local waste disposal company.||
9083|131|B|||
9083|132|A|Information last revised January 2025.||
9083|133|A|Copyright(c) 2025 First Databank, Inc.||
9083|134|B|||
9092|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9092|002|Z|does NOT have all possible information about this product. This||
9092|003|Z|information does not assure that this product is safe, effective,||
9092|004|Z|or appropriate for you. This information is not individual||
9092|005|Z|medical advice and does not substitute for the advice of your||
9092|006|Z|health care professional. Always ask your health care||
9092|007|Z|professional for complete information about this product and your||
9092|008|Z|specific health needs.||
9092|009|B|||
9092|010|T|GEMFIBROZIL - ORAL||
9092|011|F|(jem-FYE-broh-zill)||
9092|012|B|||
9092|013|C|COMMON BRAND NAME(S): Lopid||
9092|014|B|||
9092|015|U|USES:  Gemfibrozil is used along with a proper diet to help lower||
9092|016|U|fats (triglycerides) and raise "good" cholesterol (HDL) in the||
9092|017|U|blood. It may also help to lower "bad" cholesterol (LDL).||
9092|018|U|Gemfibrozil belongs to a group of drugs known as "fibrates." It||
9092|019|U|works by decreasing the amount of fat produced by the liver.||
9092|020|U|Lowering triglycerides in people with very high triglyceride||
9092|021|U|blood levels may decrease the risk of pancreas disease||
9092|022|U|(pancreatitis). However, gemfibrozil might not lower your risk of||
9092|023|U|a heart attack or stroke. Talk to your doctor about the risk and||
9092|024|U|benefits of gemfibrozil.||
9092|025|U|   In addition to eating a proper diet (such as a||
9092|026|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
9092|027|U|help this medication work better include exercising, drinking||
9092|028|U|less alcohol, losing weight if overweight, and stopping smoking.||
9092|029|B|||
9092|030|H|HOW TO USE:  Take this medication by mouth as directed by your||
9092|031|H|doctor, usually twice a day (30 minutes before your morning and||
9092|032|H|evening meals).||
9092|033|H|   The dosage is based on your medical condition and response to||
9092|034|H|treatment.||
9092|035|H|   If you also take certain other drugs to lower your cholesterol||
9092|036|H|(bile acid-binding resins such as cholestyramine or colestipol),||
9092|037|H|take gemfibrozil at least 1 hour before or at least 4-6 hours||
9092|038|H|after taking these medications. These products can react with||
9092|039|H|gemfibrozil, preventing its full absorption.||
9092|040|H|   Take this medication regularly in order to get the most||
9092|041|H|benefit from it. Remember to take it at the same times each day.||
9092|042|H|Keep taking this medication even if you feel well. Most people||
9092|043|H|with high cholesterol/triglycerides do not feel sick.||
9092|044|H|   It is very important to continue to follow your doctor's||
9092|045|H|advice about diet and exercise. It may take up to 3 months before||
9092|046|H|you get the full benefit of this drug.||
9092|047|B|||
9092|048|S|SIDE EFFECTS:  Stomach upset, stomach/abdominal pain, or unusual||
9092|049|S|taste may occur. If any of these effects last or get worse, tell||
9092|050|S|your doctor or pharmacist promptly.||
9092|051|S|   Remember that this medication has been prescribed because your||
9092|052|S|doctor has judged that the benefit to you is greater than the||
9092|053|S|risk of side effects. Many people using this medication do not||
9092|054|S|have serious side effects.||
9092|055|S|   This medication may rarely cause gallstones and liver||
9092|056|S|problems. Tell your doctor right away if you notice any of these||
9092|057|S|serious side effects: nausea/vomiting that doesn't stop, severe||
9092|058|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
9092|059|S|   This drug may rarely cause muscle problems (which can rarely||
9092|060|S|lead to a very serious condition called rhabdomyolysis). Tell||
9092|061|S|your doctor right away if you develop any of these symptoms:||
9092|062|S|muscle pain/tenderness/weakness (especially with fever or unusual||
9092|063|S|tiredness), signs of kidney problems (such as change in the||
9092|064|S|amount of urine).||
9092|065|S|   Tell your doctor right away if you have any serious side||
9092|066|S|effects, including: signs of infection (such as sore throat that||
9092|067|S|doesn't go away, fever, chills), easy bruising/bleeding, unusual||
9092|068|S|tiredness, irregular heartbeat, numbness/tingling of arms/legs.||
9092|069|S|   A very serious allergic reaction to this drug is rare.||
9092|070|S|However, get medical help right away if you notice any symptoms||
9092|071|S|of a serious allergic reaction, including: rash, itching/swelling||
9092|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9092|073|S|breathing.||
9092|074|S|   This is not a complete list of possible side effects. If you||
9092|075|S|notice other effects not listed above, contact your doctor or||
9092|076|S|pharmacist.||
9092|077|S|   In the US -||
9092|078|S|   Call your doctor for medical advice about side effects. You||
9092|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9092|080|S|www.fda.gov/medwatch.||
9092|081|S|   In Canada - Call your doctor for medical advice about side||
9092|082|S|effects. You may report side effects to Health Canada at||
9092|083|S|1-866-234-2345.||
9092|084|B|||
9092|085|P|PRECAUTIONS:  Before taking gemfibrozil, tell your doctor or||
9092|086|P|pharmacist if you are allergic to it; or to other "fibrates"||
9092|087|P|(such as fenofibrate); or if you have any other allergies. This||
9092|088|P|product may contain inactive ingredients, which can cause||
9092|089|P|allergic reactions or other problems. Talk to your pharmacist for||
9092|090|P|more details.||
9092|091|P|   Before using this medication, tell your doctor or pharmacist||
9092|092|P|your medical history, especially of: liver disease (such as||
9092|093|P|biliary cholangitis, hepatitis), gallbladder disease, kidney||
9092|094|P|disease, alcohol use.||
9092|095|P|   Before having surgery, tell your doctor or dentist about all||
9092|096|P|the products you use (including prescription drugs,||
9092|097|P|nonprescription drugs, and herbal products).||
9092|098|P|   Older adults may be more sensitive to the side effects of this||
9092|099|P|drug, especially muscle problems.||
9092|100|P|   Tell your doctor if you are pregnant or plan to become||
9092|101|P|pregnant. You should not become pregnant while using gemfibrozil.||
9092|102|P|Gemfibrozil may harm an unborn baby. If you become pregnant, talk||
9092|103|P|to your doctor right away about the risks and benefits of this||
9092|104|P|medication.||
9092|105|P|   It is unknown if this medication passes into breast milk.||
9092|106|P|Because of the possible risk to the infant, breastfeeding is not||
9092|107|P|recommended while using this medication. Consult your doctor||
9092|108|P|before breastfeeding.||
9092|109|B|||
9092|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9092|111|I|medications work or increase your risk for serious side effects.||
9092|112|I|This document does not contain all possible drug interactions.||
9092|113|I|Keep a list of all the products you use (including||
9092|114|I|prescription/nonprescription drugs and herbal products) and share||
9092|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
9092|116|I|the dosage of any medicines without your doctor's approval.||
9092|117|I|   Some products that may interact with this drug include: "blood||
9092|118|I|thinners" (such as warfarin), colchicine, repaglinide, "statin"||
9092|119|I|drugs (such as atorvastatin, lovastatin, simvastatin).||
9092|120|I|   This medication can slow down the removal of other medications||
9092|121|I|from your body, which may affect how they work. Examples of||
9092|122|I|affected drugs include daprodustat, elagolix, iptacopan,||
9092|123|I|irinotecan, pioglitazone, resmetirom, selexipag, tovorafenib,||
9092|124|I|among others.||
9092|125|B|||
9092|126|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9092|127|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9092|128|O|poison control center right away. US residents can call||
9092|129|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9092|130|B|||
9092|131|N|NOTES:  Do not share this medication with others.||
9092|132|N|   Lab and/or medical tests (such as cholesterol/triglyceride||
9092|133|N|levels, kidney/liver function, complete blood count) should be||
9092|134|N|done while you are taking this medication. Keep all medical and||
9092|135|N|lab appointments. Consult your doctor for more details.||
9092|136|B|||
9092|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9092|138|D|remember. If it is near the time of the next dose, skip the||
9092|139|D|missed dose. Take your next dose at the regular time. Do not||
9092|140|D|double the dose to catch up.||
9092|141|B|||
9092|142|R|STORAGE:  Store at room temperature away from light and moisture.||
9092|143|R|Do not store in the bathroom. Keep all medications away from||
9092|144|R|children and pets.||
9092|145|R|   Do not flush medications down the toilet or pour them into a||
9092|146|R|drain unless instructed to do so. Properly discard this product||
9092|147|R|when it is expired or no longer needed. Consult your pharmacist||
9092|148|R|or local waste disposal company.||
9092|149|B|||
9092|150|A|Information last revised May 2025.||
9092|151|A|Copyright(c) 2025 First Databank, Inc.||
9092|152|B|||
9093|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9093|002|Z|does NOT have all possible information about this product. This||
9093|003|Z|information does not assure that this product is safe, effective,||
9093|004|Z|or appropriate for you. This information is not individual||
9093|005|Z|medical advice and does not substitute for the advice of your||
9093|006|Z|health care professional. Always ask your health care||
9093|007|Z|professional for complete information about this product and your||
9093|008|Z|specific health needs.||
9093|009|B|||
9093|010|T|NORFLOXACIN - ORAL||
9093|011|F|(nor-FLOX-a-sin)||
9093|012|B|||
9093|013|C|COMMON BRAND NAME(S): Noroxin||
9093|014|B|||
9093|015|W|WARNING:  Quinolone antibiotics (including norfloxacin) may cause||
9093|016|W|serious and possibly permanent tendon damage (such as tendonitis,||
9093|017|W|tendon rupture), nerve problems in the arms and legs (peripheral||
9093|018|W|neuropathy), and nervous system problems. Get medical help right||
9093|019|W|away if you have any of the following symptoms:||
9093|020|W|pain/numbness/burning/tingling/weakness in your||
9093|021|W|arms/hands/legs/feet, changes in how you sense||
9093|022|W|touch/pain/temperature/vibration/body position, severe/lasting||
9093|023|W|headache, vision changes, shaking (tremors), seizures,||
9093|024|W|mental/mood changes (such as agitation, anxiety, confusion,||
9093|025|W|hallucinations, depression, rare thoughts of suicide).||
9093|026|W|   Tendon damage may occur during or after treatment with this||
9093|027|W|medication. Stop exercising, rest, and get medical help right||
9093|028|W|away if you develop joint/muscle/tendon pain or swelling. Your||
9093|029|W|risk for tendon problems is greater if you are over 60 years of||
9093|030|W|age, if you are taking corticosteroids (such as prednisone), or||
9093|031|W|if you have a kidney, heart, or lung transplant.||
9093|032|W|   This medication may make a certain muscle condition||
9093|033|W|(myasthenia gravis) worse. Tell your doctor right away if you||
9093|034|W|have new or worsening muscle weakness (such as drooping eyelids,||
9093|035|W|unsteady walk) or trouble breathing.||
9093|036|W|   Discuss the risks and benefits with your doctor before using||
9093|037|W|this medication.||
9093|038|B|||
9093|039|U|USES:  Norfloxacin is used to treat a variety of bacterial||
9093|040|U|infections. This medication belongs to a class of drugs known as||
9093|041|U|quinolone antibiotics. It works by stopping the growth of||
9093|042|U|bacteria.||
9093|043|U|   This antibiotic treats only bacterial infections. It will not||
9093|044|U|work for viral infections (such as common cold, flu). Using any||
9093|045|U|antibiotic when it is not needed can cause it to not work for||
9093|046|U|future infections.||
9093|047|B|||
9093|048|H|HOW TO USE:  Read the Medication Guide provided by your||
9093|049|H|pharmacist before you start taking norfloxacin and each time you||
9093|050|H|get a refill. If you have any questions, ask your doctor or||
9093|051|H|pharmacist.||
9093|052|H|   Take this medication by mouth as directed by your doctor,||
9093|053|H|usually twice a day (every 12 hours) with a full glass of water||
9093|054|H|(8 ounces/240 milliliters). Do not have any food or dairy||
9093|055|H|products (such as milk/yogurt) within 2 hours before or 1 hour||
9093|056|H|after taking norfloxacin. Drink plenty of fluids while taking||
9093|057|H|this drug unless your doctor tells you otherwise. The dosage and||
9093|058|H|length of treatment are based on your medical condition and||
9093|059|H|response to treatment.||
9093|060|H|   Take this medication at least 2 hours before or 2 hours after||
9093|061|H|taking other products that may make it work less well. Examples||
9093|062|H|include quinapril, sucralfate, vitamins/minerals (including iron,||
9093|063|H|zinc), and products that contain magnesium, aluminum, or calcium||
9093|064|H|(such as antacids, juice with added calcium), among others. Ask||
9093|065|H|your pharmacist about all the products you take.||
9093|066|H|   Norfloxacin may increase and/or prolong the effects of||
9093|067|H|caffeine. Avoid drinking large amounts of beverages containing||
9093|068|H|caffeine (coffee, tea, colas), eating large amounts of chocolate,||
9093|069|H|or taking nonprescription products that contain caffeine.||
9093|070|H|   For the best effect, take this antibiotic at evenly spaced||
9093|071|H|times. To help you remember, take this medication at the same||
9093|072|H|times every day.||
9093|073|H|   Continue to take this medication until the full prescribed||
9093|074|H|amount is finished, even if symptoms disappear after a few days.||
9093|075|H|Stopping the medication too early may result in a return of the||
9093|076|H|infection.||
9093|077|H|   Tell your doctor if your condition lasts or gets worse.||
9093|078|B|||
9093|079|S|SIDE EFFECTS:  See also Warning section.||
9093|080|S|   Nausea, diarrhea, dizziness, headache, or trouble sleeping may||
9093|081|S|occur. If any of these effects last or get worse, tell your||
9093|082|S|doctor or pharmacist promptly.||
9093|083|S|   Remember that this medication has been prescribed because your||
9093|084|S|doctor has judged that the benefit to you is greater than the||
9093|085|S|risk of side effects. Many people using this medication do not||
9093|086|S|have serious side effects.||
9093|087|S|   Tell your doctor right away if you have any serious side||
9093|088|S|effects, including: unusual bruising/bleeding, signs of kidney||
9093|089|S|problems (such as change in the amount of urine), signs of liver||
9093|090|S|problems (such as nausea/vomiting that doesn't stop, loss of||
9093|091|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
9093|092|S|urine).||
9093|093|S|   Get medical help right away if you have any very serious side||
9093|094|S|effects, including: severe dizziness, fainting, fast/irregular||
9093|095|S|heartbeat, signs of a tear/break in the main blood vessel called||
9093|096|S|the aorta (such as sudden/severe pain in the stomach/chest/back,||
9093|097|S|shortness of breath).||
9093|098|S|   This medication may rarely cause a severe intestinal condition||
9093|099|S|due to a bacteria called C. difficile. This condition may occur||
9093|100|S|during treatment or weeks to months after treatment has stopped.||
9093|101|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9093|102|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9093|103|S|stool.||
9093|104|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9093|105|S|products because they may make symptoms worse.||
9093|106|S|   Use of this medication for prolonged or repeated periods may||
9093|107|S|result in oral thrush or a new yeast infection. Contact your||
9093|108|S|doctor if you notice white patches in your mouth, a change in||
9093|109|S|vaginal discharge, or other new symptoms.||
9093|110|S|   A very serious allergic reaction to this drug is rare.||
9093|111|S|However, get medical help right away if you notice any symptoms||
9093|112|S|of a serious allergic reaction, including: rash, itching/swelling||
9093|113|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9093|114|S|breathing.||
9093|115|S|   This is not a complete list of possible side effects. If you||
9093|116|S|notice other effects not listed above, contact your doctor or||
9093|117|S|pharmacist.||
9093|118|S|   In the US -||
9093|119|S|   Call your doctor for medical advice about side effects. You||
9093|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9093|121|S|www.fda.gov/medwatch.||
9093|122|S|   In Canada - Call your doctor for medical advice about side||
9093|123|S|effects. You may report side effects to Health Canada at||
9093|124|S|1-866-234-2345.||
9093|125|B|||
9093|126|P|PRECAUTIONS:  Before taking norfloxacin, tell your doctor or||
9093|127|P|pharmacist if you are allergic to it; or to other quinolone||
9093|128|P|antibiotics such as ciprofloxacin, gemifloxacin, levofloxacin; or||
9093|129|P|if you have any other allergies. This product may contain||
9093|130|P|inactive ingredients, which can cause allergic reactions or other||
9093|131|P|problems. Talk to your pharmacist for more details.||
9093|132|P|   Before using this medication, tell your doctor or pharmacist||
9093|133|P|your medical history, especially of: joint/tendon problems (such||
9093|134|P|as tendonitis, bursitis), kidney disease, mental/mood disorders||
9093|135|P|(such as depression), a certain muscle condition (myasthenia||
9093|136|P|gravis), nerve problems (such as peripheral neuropathy), seizure||
9093|137|P|disorder, blood vessel problems (such as aneurysm or blockage of||
9093|138|P|the aorta or other blood vessels, hardening of the arteries),||
9093|139|P|high blood pressure, certain genetic conditions (Marfan syndrome,||
9093|140|P|Ehlers-Danlos syndrome).||
9093|141|P|   Norfloxacin may cause a condition that affects the heart||
9093|142|P|rhythm (QT prolongation). QT prolongation can rarely cause||
9093|143|P|serious (rarely fatal) fast/irregular heartbeat and other||
9093|144|P|symptoms (such as severe dizziness, fainting) that need medical||
9093|145|P|attention right away.||
9093|146|P|   The risk of QT prolongation may be increased if you have||
9093|147|P|certain medical conditions or are taking other drugs that may||
9093|148|P|cause QT prolongation. Before using norfloxacin, tell your doctor||
9093|149|P|or pharmacist of all the drugs you take and if you have any of||
9093|150|P|the following conditions: certain heart problems (heart failure,||
9093|151|P|slow heartbeat, QT prolongation in the EKG), family history of||
9093|152|P|certain heart problems (QT prolongation in the EKG, sudden||
9093|153|P|cardiac death).||
9093|154|P|   Low levels of potassium or magnesium in the blood may also||
9093|155|P|increase your risk of QT prolongation. This risk may increase if||
9093|156|P|you use certain drugs (such as diuretics/"water pills") or if you||
9093|157|P|have conditions such as severe sweating, diarrhea, or vomiting.||
9093|158|P|Talk to your doctor about using norfloxacin safely.||
9093|159|P|   This medication may rarely cause serious changes in blood||
9093|160|P|sugar, especially if you have diabetes. Check your blood sugar||
9093|161|P|regularly as directed and share the results with your doctor.||
9093|162|P|Watch for symptoms of high blood sugar, such as increased||
9093|163|P|thirst/urination. Also watch for symptoms of low blood sugar such||
9093|164|P|as sudden sweating, shaking, fast heartbeat, hunger, blurred||
9093|165|P|vision, dizziness, or tingling hands/feet. It is a good habit to||
9093|166|P|carry glucose tablets or gel to treat low blood sugar. If you||
9093|167|P|don't have these reliable forms of glucose, rapidly raise your||
9093|168|P|blood sugar by eating a quick source of sugar such as table||
9093|169|P|sugar, honey, or candy, or by drinking fruit juice or non-diet||
9093|170|P|soda. Tell your doctor right away about the reaction and the use||
9093|171|P|of this product. To help prevent low blood sugar, eat meals on a||
9093|172|P|regular schedule, and do not skip meals. Your doctor may need to||
9093|173|P|switch you to another antibiotic or adjust your diabetes||
9093|174|P|medications if any reaction occurs.||
9093|175|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9093|176|P|can make you more dizzy. Do not drive, use machinery, or do||
9093|177|P|anything that needs alertness until you can do it safely. Limit||
9093|178|P|alcoholic beverages. Talk to your doctor if you are using||
9093|179|P|marijuana (cannabis).||
9093|180|P|   This medication may make you more sensitive to the sun. Limit||
9093|181|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9093|182|P|sunscreen and wear protective clothing when outdoors. Tell your||
9093|183|P|doctor right away if you get sunburned or have skin||
9093|184|P|blisters/redness.||
9093|185|P|   Norfloxacin may cause live bacterial vaccines (such as typhoid||
9093|186|P|vaccine) to not work well. Tell your health care professional||
9093|187|P|that you are using norfloxacin before having any||
9093|188|P|immunizations/vaccinations.||
9093|189|P|   Before having surgery, tell your doctor or dentist about all||
9093|190|P|the products you use (including prescription drugs,||
9093|191|P|nonprescription drugs, and herbal products).||
9093|192|P|   Children may be at greater risk for joint/tendon problems||
9093|193|P|while using this drug. Discuss the risks and benefits with the||
9093|194|P|doctor.||
9093|195|P|   Older adults may be at greater risk for tendon problems||
9093|196|P|(especially if they are also taking corticosteroids such as||
9093|197|P|prednisone or hydrocortisone), QT prolongation, and a sudden||
9093|198|P|tear/break in the main blood vessel (aorta).||
9093|199|P|   During pregnancy, this medication should be used only when||
9093|200|P|clearly needed. Discuss the risks and benefits with your doctor.||
9093|201|P|   It is unknown if this drug passes into breast milk. However,||
9093|202|P|similar drugs pass into breast milk. Consult your doctor before||
9093|203|P|breastfeeding.||
9093|204|B|||
9093|205|I|DRUG INTERACTIONS:  See also How to Use section.||
9093|206|I|   Drug interactions may change how your medications work or||
9093|207|I|increase your risk for serious side effects. This document does||
9093|208|I|not contain all possible drug interactions. Keep a list of all||
9093|209|I|the products you use (including prescription/nonprescription||
9093|210|I|drugs and herbal products) and share it with your doctor and||
9093|211|I|pharmacist. Do not start, stop, or change the dosage of any||
9093|212|I|medicines without your doctor's approval.||
9093|213|I|   Some products that may interact with this drug are:||
9093|214|I|fezolinetant, strontium.||
9093|215|B|||
9093|216|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9093|217|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9093|218|O|poison control center right away. US residents can call||
9093|219|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9093|220|B|||
9093|221|N|NOTES:  Do not share this medication with others.||
9093|222|N|   This medication has been prescribed for your current condition||
9093|223|N|only. Do not use it later for another infection unless your||
9093|224|N|doctor tells you to.||
9093|225|N|   Lab tests (such as kidney function, complete blood count,||
9093|226|N|blood sugar, cultures) may be done before you start taking this||
9093|227|N|medication and while you are taking it. Keep all medical and lab||
9093|228|N|appointments.||
9093|229|B|||
9093|230|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9093|231|D|remember. If it is near the time of the next dose, skip the||
9093|232|D|missed dose. Take your next dose at the regular time. Do not||
9093|233|D|double the dose to catch up.||
9093|234|B|||
9093|235|R|STORAGE:  Store at room temperature away from light and moisture.||
9093|236|R|Do not store in the bathroom. Keep all medications away from||
9093|237|R|children and pets.||
9093|238|R|   Do not flush medications down the toilet or pour them into a||
9093|239|R|drain unless instructed to do so. Properly discard this product||
9093|240|R|when it is expired or no longer needed. Consult your pharmacist||
9093|241|R|or local waste disposal company.||
9093|242|B|||
9093|243|A|Information last revised September 2025.||
9093|244|A|Copyright(c) 2025 First Databank, Inc.||
9093|245|B|||
9095|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9095|002|Z|does NOT have all possible information about this product. This||
9095|003|Z|information does not assure that this product is safe, effective,||
9095|004|Z|or appropriate for you. This information is not individual||
9095|005|Z|medical advice and does not substitute for the advice of your||
9095|006|Z|health care professional. Always ask your health care||
9095|007|Z|professional for complete information about this product and your||
9095|008|Z|specific health needs.||
9095|009|B|||
9095|010|T|PAROXETINE - ORAL||
9095|011|F|(pa-ROX-e-teen)||
9095|012|B|||
9095|013|C|COMMON BRAND NAME(S): Paxil||
9095|014|B|||
9095|015|W|WARNING:  Antidepressant medications are used to treat a variety||
9095|016|W|of conditions, including depression and other mental/mood||
9095|017|W|disorders. These medications can help prevent suicidal||
9095|018|W|thoughts/attempts and provide other important benefits. However,||
9095|019|W|studies have shown that a small number of people (especially||
9095|020|W|people younger than 25) who take antidepressants for any||
9095|021|W|condition may experience worsening depression, other mental/mood||
9095|022|W|symptoms, or suicidal thoughts/attempts. It is very important to||
9095|023|W|talk with the doctor about the risks and benefits of||
9095|024|W|antidepressant medication (especially for people younger than||
9095|025|W|25), even if treatment is not for a mental/mood condition.||
9095|026|W|   Tell the doctor right away if you notice worsening||
9095|027|W|depression/other psychiatric conditions, unusual behavior changes||
9095|028|W|(including possible suicidal thoughts/attempts), or other||
9095|029|W|mental/mood changes (including new/worsening anxiety, panic||
9095|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
9095|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
9095|032|W|especially watchful for these symptoms when a new antidepressant||
9095|033|W|is started or when the dose is changed.||
9095|034|B|||
9095|035|U|USES:  This medication is used to treat certain mental/mood||
9095|036|U|disorders (such as depression, panic attacks, obsessive||
9095|037|U|compulsive disorder, anxiety disorders, post-traumatic stress||
9095|038|U|disorder). Paroxetine belongs to a class of drugs known as||
9095|039|U|selective serotonin reuptake inhibitors (SSRIs). It works by||
9095|040|U|helping to restore the balance of a certain natural substance||
9095|041|U|(serotonin) in the brain.||
9095|042|B|||
9095|043|V|OTHER USES:  This section contains uses of this drug that are not||
9095|044|V|listed in the approved professional labeling for the drug but||
9095|045|V|that may be prescribed by your health care professional. Use this||
9095|046|V|drug for a condition that is listed in this section only if it||
9095|047|V|has been so prescribed by your health care professional.||
9095|048|V|   This drug may also be used for a severe form of premenstrual||
9095|049|V|syndrome (premenstrual dysphoric disorder), or for hot flashes||
9095|050|V|that occur with menopause.||
9095|051|B|||
9095|052|H|HOW TO USE:  Read the Medication Guide and, if available, the||
9095|053|H|Patient Information Leaflet provided by your pharmacist before||
9095|054|H|you start taking paroxetine and each time you get a refill. If||
9095|055|H|you have any questions, ask your doctor or pharmacist.||
9095|056|H|   Take this medication by mouth with or without food as directed||
9095|057|H|by your doctor, usually once daily in the morning. Taking this||
9095|058|H|medication with food may decrease nausea. If this medication||
9095|059|H|makes you sleepy during the day, then talk to your doctor about||
9095|060|H|taking it in the evening.||
9095|061|H|   The dosage is based on your medical condition, response to||
9095|062|H|treatment, age, and other medications you may be taking. Be sure||
9095|063|H|to tell your doctor and pharmacist about all the products you use||
9095|064|H|(including prescription drugs, nonprescription drugs, and herbal||
9095|065|H|products). To reduce your risk of side effects, your doctor may||
9095|066|H|start you at a low dose and gradually increase your dose. Follow||
9095|067|H|your doctor's instructions carefully. Do not increase your dose||
9095|068|H|or use this drug more often or for longer than prescribed. Your||
9095|069|H|condition will not improve any faster, and your risk of side||
9095|070|H|effects will increase. Take this medication regularly to get the||
9095|071|H|most benefit from it. To help you remember, take it at the same||
9095|072|H|time each day.||
9095|073|H|   If you are taking paroxetine for premenstrual problems, your||
9095|074|H|doctor may direct you to take it every day of the month or just||
9095|075|H|for the 2 weeks before your period through the first full day of||
9095|076|H|your period.||
9095|077|H|   Keep taking this medication even if you feel well. Do not stop||
9095|078|H|taking this medication without consulting your doctor. Some||
9095|079|H|conditions may become worse when this drug is suddenly stopped.||
9095|080|H|Also, you may experience symptoms such as mood swings, headache,||
9095|081|H|tiredness, sleep changes, and brief feelings similar to electric||
9095|082|H|shock. To prevent these symptoms while you are stopping treatment||
9095|083|H|with this drug, your doctor may reduce your dose gradually.||
9095|084|H|Consult your doctor or pharmacist for more details. Report any||
9095|085|H|new or worsening symptoms right away.||
9095|086|H|   It may take up to several weeks before you get the full||
9095|087|H|benefit of this drug.||
9095|088|H|   Tell your doctor if your condition does not get better or if||
9095|089|H|it gets worse.||
9095|090|B|||
9095|091|S|SIDE EFFECTS:  See also Warning section.||
9095|092|S|   Nausea, drowsiness, dizziness, trouble sleeping, loss of||
9095|093|S|appetite, weakness, dry mouth, sweating, blurred vision, and||
9095|094|S|yawning may occur. If any of these effects last or get worse,||
9095|095|S|tell your doctor or pharmacist promptly.||
9095|096|S|   Remember that this medication has been prescribed because your||
9095|097|S|doctor has judged that the benefit to you is greater than the||
9095|098|S|risk of side effects. Many people using this medication do not||
9095|099|S|have serious side effects.||
9095|100|S|   Tell your doctor right away if you have any serious side||
9095|101|S|effects, including: shaking (tremor), restlessness, inability to||
9095|102|S|keep still, decreased interest in sex, changes in sexual ability,||
9095|103|S|numbness/tingling, easy bleeding/bruising, fast/irregular||
9095|104|S|heartbeat, muscle weakness/spasm, seizures.||
9095|105|S|   Get medical help right away if you have any very serious side||
9095|106|S|effects, including: black stools, vomit that looks like coffee||
9095|107|S|grounds, eye pain/swelling/redness, widened pupils, vision||
9095|108|S|changes (such as seeing rainbows around lights at night).||
9095|109|S|   This medication may increase serotonin and rarely cause a very||
9095|110|S|serious condition called serotonin syndrome/toxicity. The risk||
9095|111|S|increases if you are also taking other drugs that increase||
9095|112|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
9095|113|S|take (see Drug Interactions section). Get medical help right away||
9095|114|S|if you develop some of the following symptoms fast heartbeat,||
9095|115|S|hallucinations, loss of coordination, severe dizziness, severe||
9095|116|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
9095|117|S|unusual agitation/restlessness.||
9095|118|S|   Rarely, males may have a painful or prolonged erection lasting||
9095|119|S|4 or more hours. If this occurs, stop using this drug and get||
9095|120|S|medical help right away, or permanent problems could occur.||
9095|121|S|   A very serious allergic reaction to this drug is rare.||
9095|122|S|However, get medical help right away if you notice any symptoms||
9095|123|S|of a serious allergic reaction, including: rash, itching/swelling||
9095|124|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9095|125|S|breathing.||
9095|126|S|   This is not a complete list of possible side effects. If you||
9095|127|S|notice other effects not listed above, contact your doctor or||
9095|128|S|pharmacist.||
9095|129|S|   In the US -||
9095|130|S|   Call your doctor for medical advice about side effects. You||
9095|131|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9095|132|S|www.fda.gov/medwatch.||
9095|133|S|   In Canada - Call your doctor for medical advice about side||
9095|134|S|effects. You may report side effects to Health Canada at||
9095|135|S|1-866-234-2345.||
9095|136|B|||
9095|137|P|PRECAUTIONS:  Before taking paroxetine, tell your doctor or||
9095|138|P|pharmacist if you are allergic to it; or if you have any other||
9095|139|P|allergies. This product may contain inactive ingredients, which||
9095|140|P|can cause allergic reactions or other problems. Talk to your||
9095|141|P|pharmacist for more details.||
9095|142|P|   Before using this medication, tell your doctor or pharmacist||
9095|143|P|your medical history, especially of: personal or family history||
9095|144|P|of bipolar/manic-depressive disorder, personal or family history||
9095|145|P|of suicide attempts, liver problems, kidney problems, seizures,||
9095|146|P|low sodium in the blood, bleeding problems, personal or family||
9095|147|P|history of glaucoma (angle-closure type).||
9095|148|P|   This drug may make you dizzy or drowsy or blur your vision.||
9095|149|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9095|150|P|drowsy. Do not drive, use machinery, or do anything that needs||
9095|151|P|alertness or clear vision until you can do it safely. Avoid||
9095|152|P|alcoholic beverages. Talk to your doctor if you are using||
9095|153|P|marijuana (cannabis).||
9095|154|P|   Before having surgery, tell your doctor or dentist about all||
9095|155|P|the products you use (including prescription drugs,||
9095|156|P|nonprescription drugs, and herbal products).||
9095|157|P|   Older adults may be more sensitive to the side effects of this||
9095|158|P|drug, especially bleeding or loss of coordination. Older adults||
9095|159|P|may also be more likely to develop a type of salt imbalance||
9095|160|P|(hyponatremia), especially if they are also taking "water pills"||
9095|161|P|(diuretics). Loss of coordination can increase the risk of||
9095|162|P|falling.||
9095|163|P|   Children may be more sensitive to the side effects of this||
9095|164|P|drug, especially loss of appetite and weight loss. Monitor weight||
9095|165|P|and height in children who are taking this drug.||
9095|166|P|   This medication is not recommended for use during pregnancy.||
9095|167|P|It may harm an unborn baby, and babies born to mothers who have||
9095|168|P|used it during the last 3 months of pregnancy may sometimes||
9095|169|P|develop withdrawal symptoms such as feeding/breathing||
9095|170|P|difficulties, seizures, muscle stiffness, or constant crying.||
9095|171|P|However, since untreated mental/mood problems (such as||
9095|172|P|depression, panic attack, obsessive-compulsive disorder, and||
9095|173|P|anxiety) can harm a pregnant woman and her unborn baby, do not||
9095|174|P|stop taking this medication unless directed by your doctor.||
9095|175|P|Instead, ask your doctor if a different medication would be right||
9095|176|P|for you. If you are planning pregnancy, become pregnant, or think||
9095|177|P|you may be pregnant, tell your doctor right away.||
9095|178|P|   This drug passes into breast milk. Consult your doctor before||
9095|179|P|breastfeeding.||
9095|180|B|||
9095|181|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9095|182|I|medications work or increase your risk for serious side effects.||
9095|183|I|This document does not contain all possible drug interactions.||
9095|184|I|Keep a list of all the products you use (including||
9095|185|I|prescription/nonprescription drugs and herbal products) and share||
9095|186|I|it with your doctor and pharmacist. Do not start, stop, or change||
9095|187|I|the dosage of any medicines without your doctor's approval.||
9095|188|I|   Some products that may interact with this drug are:||
9095|189|I|thioridazine, other drugs that can cause bleeding/bruising||
9095|190|I|(including antiplatelet drugs such as clopidogrel, NSAIDs such as||
9095|191|I|ibuprofen/naproxen, "blood thinners" such as||
9095|192|I|dabigatran/warfarin).||
9095|193|I|   Aspirin can increase the risk of bleeding when used with this||
9095|194|I|medication. However, if your doctor has told you to take low-dose||
9095|195|I|aspirin to prevent heart attack or stroke (usually 81-162||
9095|196|I|milligrams a day), you should keep taking the aspirin unless your||
9095|197|I|doctor tells you not to. Ask your doctor or pharmacist for more||
9095|198|I|details.||
9095|199|I|   This medication can slow down the removal of other medications||
9095|200|I|from your body, which may affect how they work. Examples of||
9095|201|I|affected drugs include atomoxetine, phenothiazines, pimozide,||
9095|202|I|risperidone, tamoxifen, tetrabenazine, antiarrhythmics such as||
9095|203|I|propafenone/flecainide, TCA antidepressants such as||
9095|204|I|desipramine/amitriptyline, among others.||
9095|205|I|   Taking MAO inhibitors with this medication may cause a serious||
9095|206|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9095|207|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9095|208|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9095|209|I|selegiline, tranylcypromine) during treatment with this||
9095|210|I|medication. Most MAO inhibitors should also not be taken for two||
9095|211|I|weeks before and after treatment with this medication. Ask your||
9095|212|I|doctor when to start or stop taking this medication.||
9095|213|I|   The risk of serotonin syndrome/toxicity increases if you are||
9095|214|I|also taking other drugs that increase serotonin. Examples include||
9095|215|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
9095|216|I|antidepressants (including other SSRIs such as||
9095|217|I|citalopram/fluoxetine, SNRIs such as duloxetine/venlafaxine),||
9095|218|I|tryptophan, among others. The risk of serotonin syndrome/toxicity||
9095|219|I|may be more likely when you start or increase the dose of these||
9095|220|I|drugs.||
9095|221|I|   Tell your doctor or pharmacist if you are taking other||
9095|222|I|products that cause drowsiness including alcohol, marijuana||
9095|223|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
9095|224|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
9095|225|I|zolpidem), muscle relaxants, and opioid pain relievers (such as||
9095|226|I|codeine).||
9095|227|I|   Check the labels on all your medicines (such as allergy or||
9095|228|I|cough-and-cold products) because they may contain ingredients||
9095|229|I|that cause drowsiness. Ask your pharmacist about using those||
9095|230|I|products safely.||
9095|231|I|   This medication may interfere with certain medical/lab tests||
9095|232|I|(such as brain scan for Parkinson's disease), possibly causing||
9095|233|I|false test results. Make sure lab personnel and all your doctors||
9095|234|I|know you use this drug.||
9095|235|B|||
9095|236|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9095|237|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9095|238|O|poison control center right away. US residents can call||
9095|239|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9095|240|O|Symptoms of overdose may include: irregular heartbeat, fainting,||
9095|241|O|severe dizziness, seizures.||
9095|242|B|||
9095|243|N|NOTES:  Do not share this medication with others.||
9095|244|N|   Keep all medical and lab appointments.||
9095|245|B|||
9095|246|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9095|247|D|remember. If it is near the time of the next dose, skip the||
9095|248|D|missed dose. Take your next dose at the regular time. Do not||
9095|249|D|double the dose to catch up.||
9095|250|B|||
9095|251|R|STORAGE:  Store at room temperature away from light and moisture.||
9095|252|R|Do not store in the bathroom. Keep all medications away from||
9095|253|R|children and pets.||
9095|254|R|   Do not flush medications down the toilet or pour them into a||
9095|255|R|drain unless instructed to do so. Properly discard this product||
9095|256|R|when it is expired or no longer needed. Consult your pharmacist||
9095|257|R|or local waste disposal company.||
9095|258|B|||
9095|259|A|Information last revised February 2025.||
9095|260|A|Copyright(c) 2025 First Databank, Inc.||
9095|261|B|||
9099|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9099|002|Z|does NOT have all possible information about this product. This||
9099|003|Z|information does not assure that this product is safe, effective,||
9099|004|Z|or appropriate for you. This information is not individual||
9099|005|Z|medical advice and does not substitute for the advice of your||
9099|006|Z|health care professional. Always ask your health care||
9099|007|Z|professional for complete information about this product and your||
9099|008|Z|specific health needs.||
9099|009|B|||
9099|010|T|HOMATROPINE HYDROBROMIDE SOLUTION - OPHTHALMIC||
9099|011|F|(hoe-MAT-roe-peen HYE-droe-BROE-mide)||
9099|012|B|||
9099|013|C|COMMON BRAND NAME(S): Isopto Homatropine||
9099|014|B|||
9099|015|U|USES:  This medication is used before eye examinations (such as||
9099|016|U|refraction), before and after certain eye surgeries, and to treat||
9099|017|U|certain eye conditions (such as uveitis). It belongs to a class||
9099|018|U|of drugs known as anticholinergics. Homatropine hydrobromide||
9099|019|U|works by widening (dilating) the pupil of the eye.||
9099|020|B|||
9099|021|H|HOW TO USE:  Use this medication in the affected eye(s) as||
9099|022|H|directed by your doctor, usually 2 to 3 times daily (up to every||
9099|023|H|3 to 4 hours).||
9099|024|H|   To apply eye drops, wash your hands first. To avoid||
9099|025|H|contamination, do not touch the dropper tip or let it touch your||
9099|026|H|eye or any other surface.||
9099|027|H|   If you are wearing contact lenses, remove them before using||
9099|028|H|eye drops. Wait at least 15 minutes before replacing your contact||
9099|029|H|lenses.||
9099|030|H|   Tilt your head back, look upward, and pull down the lower||
9099|031|H|eyelid to make a pouch. Hold the dropper directly over your eye||
9099|032|H|and place one drop into the pouch. Look downward and gently close||
9099|033|H|your eyes for 1-2 minutes. Place one finger at the corner of your||
9099|034|H|eye (near the nose) and apply gentle pressure for 2 to 3 minutes.||
9099|035|H|This will prevent the medication from draining out. Try not to||
9099|036|H|blink and do not rub your eye. Repeat these steps for your other||
9099|037|H|eye if so directed or if your dose is for more than 1 drop.||
9099|038|H|   Do not rinse the dropper. Replace the dropper cap after each||
9099|039|H|use. Do not use the solution if it turns brown or cloudy or if it||
9099|040|H|contains particles.||
9099|041|H|   If you are using another kind of eye medication (such as drops||
9099|042|H|or ointments), wait at least 5-10 minutes before applying other||
9099|043|H|medications. Use eye drops before eye ointments to allow the||
9099|044|H|drops to enter the eye.||
9099|045|H|   Wait several minutes for your vision to clear before driving||
9099|046|H|or operating machinery.||
9099|047|H|   If you are using this medication on a regular schedule, use it||
9099|048|H|regularly in order to get the most benefit from it. To help you||
9099|049|H|remember, use it at the same times each day. Keep using it for||
9099|050|H|the full time prescribed.||
9099|051|H|   Tell your doctor if your condition does not get better or if||
9099|052|H|it gets worse.||
9099|053|B|||
9099|054|S|SIDE EFFECTS:  Burning/stinging/redness of the eye, eye||
9099|055|S|irritation, or temporary blurred vision may occur. If any of||
9099|056|S|these effects last or get worse, notify your doctor or pharmacist||
9099|057|S|promptly.||
9099|058|S|   Remember that this medication has been prescribed because your||
9099|059|S|doctor has judged that the benefit to you is greater than the||
9099|060|S|risk of side effects. Many people using this medication do not||
9099|061|S|have serious side effects.||
9099|062|S|   Tell your doctor right away if you have any serious side||
9099|063|S|effects, including: extreme thirst, unusual dry mouth,||
9099|064|S|mental/mood changes (such as confusion, agitation),||
9099|065|S|fast/irregular heartbeat.||
9099|066|S|   Get medical help right away if you have any very serious side||
9099|067|S|effects, including: eye pain/swelling, vision changes (such as||
9099|068|S|seeing rainbows around lights at night).||
9099|069|S|   A very serious allergic reaction to this drug is rare.||
9099|070|S|However, get medical help right away if you notice any symptoms||
9099|071|S|of a serious allergic reaction, including: rash, itching/swelling||
9099|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9099|073|S|breathing.||
9099|074|S|   This is not a complete list of possible side effects. If you||
9099|075|S|notice other effects not listed above, contact your doctor or||
9099|076|S|pharmacist.||
9099|077|S|   In the US -||
9099|078|S|   Call your doctor for medical advice about side effects. You||
9099|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9099|080|S|www.fda.gov/medwatch.||
9099|081|S|   In Canada - Call your doctor for medical advice about side||
9099|082|S|effects. You may report side effects to Health Canada at||
9099|083|S|1-866-234-2345.||
9099|084|B|||
9099|085|P|PRECAUTIONS:  Before using homatropine hydrobromide, tell your||
9099|086|P|doctor or pharmacist if you are allergic to it; or to belladonna||
9099|087|P|alkaloids (such as atropine); or if you have any other allergies.||
9099|088|P|This product may contain inactive ingredients, which can cause||
9099|089|P|allergic reactions or other problems. Talk to your pharmacist for||
9099|090|P|more details.||
9099|091|P|   Before using this medication, tell your doctor or pharmacist||
9099|092|P|your medical history, especially of: personal or family history||
9099|093|P|of glaucoma (angle-closure type), other eye conditions (such as||
9099|094|P|keratoconus), Down syndrome, brain damage or spastic paralysis||
9099|095|P|(in children).||
9099|096|P|   After you apply this drug, your vision may become temporarily||
9099|097|P|blurred. Do not drive, use machinery, or do anything that needs||
9099|098|P|clear vision until you can do it safely.||
9099|099|P|   This medication may make your eyes more sensitive to light.||
9099|100|P|Protect your eyes in bright light. Use dark sunglasses when||
9099|101|P|outdoors.||
9099|102|P|   Older adults may be more sensitive to the side effects of this||
9099|103|P|drug.||
9099|104|P|   Infants or small children may be more sensitive to the side||
9099|105|P|effects of this drug. Do not allow this medication to get into||
9099|106|P|the child's mouth. Remember to wash your hands after each use.||
9099|107|P|   During pregnancy, this medication should be used only when||
9099|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
9099|109|P|   It is unknown if this drug passes into breast milk. Consult||
9099|110|P|your doctor before breastfeeding.||
9099|111|B|||
9099|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9099|113|I|medications work or increase your risk for serious side effects.||
9099|114|I|This document does not contain all possible drug interactions.||
9099|115|I|Keep a list of all the products you use (including||
9099|116|I|prescription/nonprescription drugs and herbal products) and share||
9099|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
9099|118|I|the dosage of any medicines without your doctor's approval.||
9099|119|B|||
9099|120|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9099|121|O|has overdosed and has serious symptoms such as passing out or||
9099|122|O|trouble breathing, call 911. Otherwise, call a poison control||
9099|123|O|center right away. US residents can call 1-800-222-1222. Canada||
9099|124|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9099|125|O|include: flushed/dry skin, blurred vision, fast/irregular||
9099|126|O|heartbeat, fever, mental/mood changes (such as hallucinations),||
9099|127|O|loss of coordination.||
9099|128|B|||
9099|129|N|NOTES:  Do not share this medication with others.||
9099|130|B|||
9099|131|D|MISSED DOSE:  If you are using this drug on a regular schedule||
9099|132|D|and miss a dose, use it as soon as you remember. If it is near||
9099|133|D|the time of the next dose, skip the missed dose. Use your next||
9099|134|D|dose at the regular time. Do not double the dose to catch up.||
9099|135|B|||
9099|136|R|STORAGE:  Store at room temperature away from light. Do not||
9099|137|R|freeze. Keep all medications away from children and pets.||
9099|138|R|   Do not flush medications down the toilet or pour them into a||
9099|139|R|drain unless instructed to do so. Properly discard this product||
9099|140|R|when it is expired or no longer needed. Consult your pharmacist||
9099|141|R|or local waste disposal company.||
9099|142|B|||
9099|143|A|Information last revised October 2024.||
9099|144|A|Copyright(c) 2025 First Databank, Inc.||
9099|145|B|||
9104|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9104|002|Z|does NOT have all possible information about this product. This||
9104|003|Z|information does not assure that this product is safe, effective,||
9104|004|Z|or appropriate for you. This information is not individual||
9104|005|Z|medical advice and does not substitute for the advice of your||
9104|006|Z|health care professional. Always ask your health care||
9104|007|Z|professional for complete information about this product and your||
9104|008|Z|specific health needs.||
9104|009|B|||
9104|010|T|METHAZOLAMIDE - ORAL||
9104|011|F|(METH-a-ZOL-a-mide)||
9104|012|B|||
9104|013|C|COMMON BRAND NAME(S): Neptazane||
9104|014|B|||
9104|015|U|USES:  This medication is used to treat high pressure inside the||
9104|016|U|eye due to certain types of glaucoma. Lowering high pressure||
9104|017|U|inside the eye helps to prevent blindness, vision loss, and nerve||
9104|018|U|damage. Methazolamide belongs to a class of drugs known as||
9104|019|U|carbonic anhydrase inhibitors. It works by decreasing the||
9104|020|U|production of fluid inside the eye.||
9104|021|B|||
9104|022|H|HOW TO USE:  Take this medication by mouth as directed by your||
9104|023|H|doctor, usually 2 or 3 times a day. This medication may be taken||
9104|024|H|with food if stomach upset occurs. To reduce your risk of certain||
9104|025|H|side effects (kidney stones), drink plenty of fluids unless||
9104|026|H|otherwise directed by your doctor.||
9104|027|H|   The dosage is based on your medical condition and response to||
9104|028|H|treatment.||
9104|029|H|   Use this medication regularly to get the most benefit from it.||
9104|030|H|To help you remember, take it at the same times each day. Keep||
9104|031|H|taking this medication even if you feel well. Most people with||
9104|032|H|glaucoma or high pressure in the eye(s) do not feel sick.||
9104|033|B|||
9104|034|S|SIDE EFFECTS:  Nausea, loss of appetite, change in taste,||
9104|035|S|vomiting, diarrhea, frequent urination, dizziness, drowsiness, or||
9104|036|S|tiredness may occur as your body adjusts to the medication. If||
9104|037|S|any of these effects last or get worse, tell your doctor or||
9104|038|S|pharmacist promptly.||
9104|039|S|   Remember that this medication has been prescribed because your||
9104|040|S|doctor has judged that the benefit to you is greater than the||
9104|041|S|risk of side effects. Many people using this medication do not||
9104|042|S|have serious side effects.||
9104|043|S|   Tell your doctor right away if you have any serious side||
9104|044|S|effects, including: signs of kidney stones (such as painful||
9104|045|S|urination, pink/bloody urine), signs of infection (such as sore||
9104|046|S|throat that doesn't go away, fever, chills), easy||
9104|047|S|bleeding/bruising, numbness or tingling of hands/feet, ringing in||
9104|048|S|the ears.||
9104|049|S|   Get medical help right away if you have any very serious side||
9104|050|S|effects, including: signs of liver problems (such as||
9104|051|S|nausea/vomiting that doesn't stop, loss of appetite,||
9104|052|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
9104|053|S|confusion, fast/pounding heartbeat, seizures.||
9104|054|S|   A very serious allergic reaction to this drug is rare.||
9104|055|S|However, get medical help right away if you notice any symptoms||
9104|056|S|of a serious allergic reaction, including: rash, itching/swelling||
9104|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9104|058|S|breathing.||
9104|059|S|   This is not a complete list of possible side effects. If you||
9104|060|S|notice other effects not listed above, contact your doctor or||
9104|061|S|pharmacist.||
9104|062|S|   In the US -||
9104|063|S|   Call your doctor for medical advice about side effects. You||
9104|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9104|065|S|www.fda.gov/medwatch.||
9104|066|S|   In Canada - Call your doctor for medical advice about side||
9104|067|S|effects. You may report side effects to Health Canada at||
9104|068|S|1-866-234-2345.||
9104|069|B|||
9104|070|P|PRECAUTIONS:  Before taking methazolamide, tell your doctor or||
9104|071|P|pharmacist if you are allergic to it; or if you have any other||
9104|072|P|allergies. This product may contain inactive ingredients, which||
9104|073|P|can cause allergic reactions or other problems. Talk to your||
9104|074|P|pharmacist for more details.||
9104|075|P|   Before using this medication, tell your doctor or pharmacist||
9104|076|P|your medical history, especially of: adrenal gland problems (such||
9104|077|P|as Addison's disease), liver disease (such as cirrhosis),||
9104|078|P|breathing problems (such as chronic obstructive pulmonary||
9104|079|P|disease-COPD, emphysema, lung infection), diabetes, gout, kidney||
9104|080|P|problems (such as history of kidney stones), untreated mineral||
9104|081|P|imbalance (such as low sodium/potassium, hyperchloremic||
9104|082|P|acidosis), overactive thyroid (hyperthyroidism).||
9104|083|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9104|084|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9104|085|P|machinery, or do anything that needs alertness until you can do||
9104|086|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9104|087|P|are using marijuana (cannabis).||
9104|088|P|   This medication may make you more sensitive to the sun. Limit||
9104|089|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9104|090|P|sunscreen and wear protective clothing when outdoors. Tell your||
9104|091|P|doctor right away if you get sunburned or have skin||
9104|092|P|blisters/redness.||
9104|093|P|   Before having surgery, tell your doctor or dentist about all||
9104|094|P|the products you use (such as prescription drugs, nonprescription||
9104|095|P|drugs, and herbal products).||
9104|096|P|   During pregnancy, this medication should be used only when||
9104|097|P|clearly needed. Discuss the risks and benefits with your doctor.||
9104|098|P|   It is unknown if this medication passes into breast milk.||
9104|099|P|Consult your doctor before breastfeeding.||
9104|100|B|||
9104|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9104|102|I|medications work or increase your risk for serious side effects.||
9104|103|I|This document does not contain all possible drug interactions.||
9104|104|I|Keep a list of all the products you use (such as||
9104|105|I|prescription/nonprescription drugs and herbal products) and share||
9104|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
9104|107|I|the dosage of any medicines without your doctor's approval.||
9104|108|I|   Some products that may interact with this drug are: memantine,||
9104|109|I|methenamine.||
9104|110|I|   Check the labels on all your medicines because they may||
9104|111|I|contain aspirin or aspirin-like drugs (salicylates), which can||
9104|112|I|cause serious side effects if taken in large doses with this||
9104|113|I|medication. However, if your doctor has told you to take low-dose||
9104|114|I|aspirin to prevent heart attack or stroke (usually 81-162||
9104|115|I|milligrams a day), you should keep taking the aspirin unless your||
9104|116|I|doctor tells you not to. Ask your doctor or pharmacist for more||
9104|117|I|details.||
9104|118|I|   This medication may interfere with certain lab tests, possibly||
9104|119|I|causing false test results. Make sure lab personnel and all your||
9104|120|I|doctors know you use this drug.||
9104|121|B|||
9104|122|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9104|123|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9104|124|O|poison control center right away. US residents can call||
9104|125|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9104|126|B|||
9104|127|N|NOTES:  Do not share this medication with others.||
9104|128|N|   Lab and/or medical tests (such as potassium level, complete||
9104|129|N|blood count, liver function) should be done while you are taking||
9104|130|N|this medication. Keep all medical and lab appointments. Consult||
9104|131|N|your doctor for more details.||
9104|132|B|||
9104|133|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9104|134|D|remember. If it is near the time of the next dose, skip the||
9104|135|D|missed dose. Take your next dose at the regular time. Do not||
9104|136|D|double the dose to catch up.||
9104|137|B|||
9104|138|R|STORAGE:  Store at room temperature away from light and moisture.||
9104|139|R|Do not store in the bathroom. Keep all medications away from||
9104|140|R|children and pets.||
9104|141|R|   Do not flush medications down the toilet or pour them into a||
9104|142|R|drain unless instructed to do so. Properly discard this product||
9104|143|R|when it is expired or no longer needed. Consult your pharmacist||
9104|144|R|or local waste disposal company.||
9104|145|B|||
9104|146|A|Information last revised May 2025.||
9104|147|A|Copyright(c) 2025 First Databank, Inc.||
9104|148|B|||
9105|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9105|002|Z|does NOT have all possible information about this product. This||
9105|003|Z|information does not assure that this product is safe, effective,||
9105|004|Z|or appropriate for you. This information is not individual||
9105|005|Z|medical advice and does not substitute for the advice of your||
9105|006|Z|health care professional. Always ask your health care||
9105|007|Z|professional for complete information about this product and your||
9105|008|Z|specific health needs.||
9105|009|B|||
9105|010|T|METHOCARBAMOL/ASPIRIN/CODEINE - ORAL||
9105|011|F|(meth-oh-KAR-ba-mol/AS-pir-in/KOE-deen)||
9105|012|B|||
9105|013|W|WARNING:  Codeine has a risk for abuse and addiction, which can||
9105|014|W|lead to overdose and death. Codeine may also cause severe,||
9105|015|W|possibly fatal, breathing problems. To lower your risk, your||
9105|016|W|doctor should have you take the smallest dose of codeine that||
9105|017|W|works, and take it for the shortest possible time. See also How||
9105|018|W|to Use section for more information about addiction.||
9105|019|W|   Ask your doctor or pharmacist if you should have medication||
9105|020|W|available to treat opioid overdose (such as naloxone, nalmefene).||
9105|021|W|Teach your family or household members about the signs of an||
9105|022|W|opioid overdose and how to treat it.||
9105|023|W|   The risk for severe breathing problems is higher when you||
9105|024|W|start this medication and after a dose increase, or if you take||
9105|025|W|the wrong dose/strength. Taking this medication with alcohol or||
9105|026|W|other drugs that can cause drowsiness or breathing problems may||
9105|027|W|cause very serious side effects, including death. Also, other||
9105|028|W|medications can affect the removal of codeine from your body,||
9105|029|W|which may affect how codeine works. Be sure you know how to take||
9105|030|W|this medication and what other drugs you should avoid taking with||
9105|031|W|it. See also Drug Interactions section. Get medical help right||
9105|032|W|away if any of these very serious side effects occur:||
9105|033|W|slow/shallow breathing, unusual lightheadedness, severe||
9105|034|W|drowsiness/dizziness, difficulty waking up.||
9105|035|W|   Keep this medicine in a safe place to prevent theft, misuse,||
9105|036|W|or abuse. If someone accidentally swallows this medication, get||
9105|037|W|medical help right away.||
9105|038|W|   Children younger than 18 years should not use products that||
9105|039|W|contain codeine. Some children are more sensitive to codeine and||
9105|040|W|have had very serious (rarely fatal) breathing problems such as||
9105|041|W|slow/shallow breathing (see also Side Effects section). The risk||
9105|042|W|is greater in children who are obese or have breathing problems,||
9105|043|W|or after certain surgeries (including tonsil/adenoid removal).||
9105|044|W|Talk with your doctor or pharmacist about the risks and benefits||
9105|045|W|of this medication.||
9105|046|B|||
9105|047|U|USES:  See also Warning section.||
9105|048|U|   This combination medication is used to treat muscle spasm with||
9105|049|U|moderate to severe pain. Methocarbamol helps to relax the||
9105|050|U|muscles. Aspirin helps to decrease the pain. Codeine is an opioid||
9105|051|U|pain reliever that works in the brain to change how your body||
9105|052|U|feels and responds to pain.||
9105|053|B|||
9105|054|H|HOW TO USE:  Take this medication by mouth with or without food||
9105|055|H|as directed by your doctor. Do not increase your dose or use this||
9105|056|H|drug more often or for longer than prescribed. Your condition||
9105|057|H|will not improve any faster, and your risk of side effects will||
9105|058|H|increase. Take this medication with a full glass of water (8||
9105|059|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
9105|060|H|Do not lie down for at least 10 minutes after taking this||
9105|061|H|medication. If you have stomach upset or nausea, it may help to||
9105|062|H|take this drug with food. Ask your doctor or pharmacist about||
9105|063|H|other ways to decrease nausea (such as lying down for 1 to 2||
9105|064|H|hours with as little head movement as possible).||
9105|065|H|   The dosage is based on your medical condition and response to||
9105|066|H|treatment. Use the smallest effective dose. Properly stop the||
9105|067|H|medication when so directed.||
9105|068|H|   Pain medications work best if they are used as the first signs||
9105|069|H|of pain occur. If you wait until the symptoms have worsened, the||
9105|070|H|medication may not work as well.||
9105|071|H|   If you suddenly stop using this medication, you may have||
9105|072|H|withdrawal symptoms (such as restlessness, watering eyes, runny||
9105|073|H|nose, nausea, sweating, muscle aches). To help prevent||
9105|074|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
9105|075|H|more likely if you have used this medication for a long time or||
9105|076|H|in high doses. Tell your doctor or pharmacist right away if you||
9105|077|H|have withdrawal.||
9105|078|H|   When this medication is used for a long time, it may not work||
9105|079|H|as well. Talk with your doctor if this medication stops working||
9105|080|H|well.||
9105|081|H|   Though it helps many people, this medication may sometimes||
9105|082|H|cause addiction. This risk may be higher if you have a||
9105|083|H|mental/mood disorder or a substance use disorder (such as overuse||
9105|084|H|of or addiction to drugs/alcohol). Take this medication exactly||
9105|085|H|as prescribed to lower the risk of addiction. Ask your doctor or||
9105|086|H|pharmacist for more details.||
9105|087|H|   Tell your doctor if your condition does not get better or if||
9105|088|H|it gets worse, or if you have any new pain.||
9105|089|B|||
9105|090|S|SIDE EFFECTS:  See also Warning section.||
9105|091|S|   Drowsiness, dizziness, lightheadedness, nausea/vomiting,||
9105|092|S|stomach upset, heartburn, blurred vision, or constipation may||
9105|093|S|occur. If any of these effects last or get worse, tell your||
9105|094|S|doctor or pharmacist promptly.||
9105|095|S|   To prevent constipation, eat dietary fiber, drink enough||
9105|096|S|water, and exercise. You may also need to take a laxative. Ask||
9105|097|S|your pharmacist which type of laxative is right for you.||
9105|098|S|   To reduce the risk of dizziness and lightheadedness, get up||
9105|099|S|slowly when rising from a sitting or lying position.||
9105|100|S|   Remember that this medication has been prescribed because your||
9105|101|S|doctor has judged that the benefit to you is greater than the||
9105|102|S|risk of side effects. Many people using this medication do not||
9105|103|S|have serious side effects.||
9105|104|S|   Tell your doctor right away if you have any serious side||
9105|105|S|effects, including: nausea/vomiting that doesn't stop, trouble||
9105|106|S|swallowing, easy bruising/bleeding, dark urine, yellowing||
9105|107|S|eyes/skin, hearing problems (such as ringing in the ears, hearing||
9105|108|S|loss), signs of kidney problems (such as change in the amount of||
9105|109|S|urine), fast/pounding heartbeat, interrupted breathing during||
9105|110|S|sleep (sleep apnea), mental/mood changes (such as forgetfulness),||
9105|111|S|difficulty urinating, signs of your adrenal glands not working||
9105|112|S|well (such as loss of appetite, unusual tiredness, weight loss).||
9105|113|S|   Get medical help right away if you have any very serious side||
9105|114|S|effects, including: fainting, seizures.||
9105|115|S|   Codeine is changed into a strong opioid drug (morphine) in||
9105|116|S|your body. In some people, this change happens faster and more||
9105|117|S|completely than usual, which increases the risk of very serious||
9105|118|S|side effects. Get medical help right away if you notice any of||
9105|119|S|the following: slow/shallow breathing, severe||
9105|120|S|drowsiness/difficulty waking up, confusion.||
9105|121|S|   This drug may rarely cause serious (rarely fatal) bleeding||
9105|122|S|from the stomach or intestines. If you notice any of the||
9105|123|S|following unlikely but serious side effects, stop taking this||
9105|124|S|medication and consult your doctor or pharmacist right away:||
9105|125|S|stomach/abdominal pain that doesn't go away, black stool, vomit||
9105|126|S|that looks like coffee grounds.||
9105|127|S|   A very serious allergic reaction to this drug is rare.||
9105|128|S|However, get medical help right away if you notice any symptoms||
9105|129|S|of a serious allergic reaction, including: fever, swollen lymph||
9105|130|S|nodes, rash, itching/swelling (especially of the||
9105|131|S|face/tongue/throat), severe dizziness, trouble breathing.||
9105|132|S|   This is not a complete list of possible side effects. If you||
9105|133|S|notice other effects not listed above, contact your doctor or||
9105|134|S|pharmacist.||
9105|135|S|   In the US -||
9105|136|S|   Call your doctor for medical advice about side effects. You||
9105|137|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9105|138|S|www.fda.gov/medwatch.||
9105|139|S|   In Canada - Call your doctor for medical advice about side||
9105|140|S|effects. You may report side effects to Health Canada at||
9105|141|S|1-866-234-2345.||
9105|142|B|||
9105|143|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9105|144|P|pharmacist if you are allergic to methocarbamol, aspirin, or||
9105|145|P|codeine; or to nonsteroidal anti-inflammatory drugs-NSAIDs (such||
9105|146|P|as ibuprofen); or to other salicylates (such as choline||
9105|147|P|salicylate); or to other opioid pain medications (such as||
9105|148|P|morphine); or if you have any other allergies. This product may||
9105|149|P|contain inactive ingredients, which can cause allergic reactions||
9105|150|P|or other problems. Talk to your pharmacist for more details.||
9105|151|P|   Before using this medication, tell your doctor or pharmacist||
9105|152|P|your medical history, especially of: asthma (including a history||
9105|153|P|of worsening breathing with runny/stuffy nose after taking||
9105|154|P|aspirin or other NSAIDs), growths in the nose (nasal polyps),||
9105|155|P|stomach/intestine/esophagus problems (such as ulcers, heartburn,||
9105|156|P|blockage, constipation, diarrhea due to infection, paralytic||
9105|157|P|ileus), brain disorders (such as head injury, tumor, seizures),||
9105|158|P|breathing problems (such as sleep apnea, chronic obstructive||
9105|159|P|pulmonary disease-COPD), kidney disease, liver disease,||
9105|160|P|bleeding/blood clotting disorders (such as hemophilia, von||
9105|161|P|Willebrand disease, thrombocytopenia), certain enzyme||
9105|162|P|deficiencies (such as pyruvate kinase, G6PD deficiency), gout,||
9105|163|P|mental/mood disorders (such as confusion, depression, thoughts of||
9105|164|P|suicide), personal or family history of a substance use disorder||
9105|165|P|(such as overuse of or addiction to drugs/alcohol), difficulty||
9105|166|P|urinating (such as due to enlarged prostate), gallbladder||
9105|167|P|disease, disease of the pancreas (pancreatitis), obesity.||
9105|168|P|   Before having surgery, tell your doctor or dentist about all||
9105|169|P|the products you use (including prescription drugs,||
9105|170|P|nonprescription drugs, and herbal products).||
9105|171|P|   This drug may make you dizzy or drowsy or blur your vision.||
9105|172|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9105|173|P|drowsy. Do not drive, use machinery, or do anything that needs||
9105|174|P|alertness or clear vision until you can do it safely. Avoid||
9105|175|P|alcoholic beverages. Talk to your doctor if you are using||
9105|176|P|marijuana (cannabis).||
9105|177|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
9105|178|P|and tobacco, especially when combined with this medicine, may||
9105|179|P|increase your risk for stomach bleeding. Avoid alcohol and stop||
9105|180|P|smoking. Consult your doctor or pharmacist for more information.||
9105|181|P|   This drug contains aspirin. Children and teenagers less than||
9105|182|P|18 years old should not take aspirin if they have chickenpox,||
9105|183|P|flu, or any undiagnosed illness or if they have recently received||
9105|184|P|a vaccine. In these cases, taking aspirin increases the risk of||
9105|185|P|Reye's syndrome, a rare but serious illness.||
9105|186|P|   Older adults may be more sensitive to the side effects of this||
9105|187|P|drug, especially stomach/intestinal bleeding and ulcers,||
9105|188|P|drowsiness, dizziness, confusion, or slow/shallow breathing.||
9105|189|P|Drowsiness, dizziness, and confusion can increase the risk of||
9105|190|P|falling.||
9105|191|P|   Before using this medication, women of childbearing age should||
9105|192|P|talk with their doctor(s) about the benefits and risks. Tell your||
9105|193|P|doctor if you are pregnant or if you plan to become pregnant.||
9105|194|P|This medication may harm an unborn baby and cause problems with||
9105|195|P|normal labor/delivery. It is not recommended for use in pregnancy||
9105|196|P|from 20 weeks until delivery. If your doctor decides that you||
9105|197|P|need to use this medication between 20 and 30 weeks of pregnancy,||
9105|198|P|you should use the lowest effective dose for the shortest||
9105|199|P|possible time. You should not use this medication after 30 weeks||
9105|200|P|of pregnancy.||
9105|201|P|   This product passes into breast milk and may have undesirable||
9105|202|P|effects on a nursing infant. Breastfeeding is not recommended||
9105|203|P|while using this product. Consult your doctor before||
9105|204|P|breastfeeding.||
9105|205|B|||
9105|206|I|DRUG INTERACTIONS:  See also Warning section.||
9105|207|I|   Drug interactions may change how your medications work or||
9105|208|I|increase your risk for serious side effects. This document does||
9105|209|I|not contain all possible drug interactions. Keep a list of all||
9105|210|I|the products you use (including prescription/nonprescription||
9105|211|I|drugs and herbal products) and share it with your doctor and||
9105|212|I|pharmacist. Do not start, stop, or change the dosage of any||
9105|213|I|medicines without your doctor's approval.||
9105|214|I|   Some products that may interact with this drug include:||
9105|215|I|certain pain medications (mixed opioid agonist-antagonists such||
9105|216|I|as butorphanol, nalbuphine, pentazocine), corticosteroids (such||
9105|217|I|as prednisone), mifepristone, naltrexone, samidorphan.||
9105|218|I|   This medication may increase the risk of bleeding when taken||
9105|219|I|with other drugs that also may cause bleeding. Examples include||
9105|220|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
9105|221|I|dabigatran/enoxaparin/warfarin, among others.||
9105|222|I|   Check all prescription and nonprescription medicine labels||
9105|223|I|carefully since many medications contain pain relievers/fever||
9105|224|I|reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac,||
9105|225|I|naproxen). These drugs are similar to this medication and may||
9105|226|I|increase your risk of side effects if taken together. Ask your||
9105|227|I|doctor or pharmacist for more details.||
9105|228|I|   The risk of serious side effects (such as slow/shallow||
9105|229|I|breathing, severe drowsiness/dizziness) may be increased if this||
9105|230|I|medication is taken with other products that may also cause||
9105|231|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
9105|232|I|if you are taking other products such as other opioid pain or||
9105|233|I|cough relievers (such as morphine, hydrocodone), alcohol,||
9105|234|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
9105|235|I|alprazolam, lorazepam, zolpidem), other muscle relaxants (such as||
9105|236|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
9105|237|I|cetirizine, diphenhydramine).||
9105|238|I|   Check the labels on all your medicines (such as allergy or||
9105|239|I|cough-and-cold products) because they may contain ingredients||
9105|240|I|that cause drowsiness. Ask your pharmacist about using those||
9105|241|I|products safely.||
9105|242|I|   Other medications can affect the removal of this product from||
9105|243|I|your body, which may affect how this product works. Examples||
9105|244|I|include azole antifungals (such as ketoconazole), bupropion,||
9105|245|I|fluoxetine, macrolide antibiotics (such as erythromycin),||
9105|246|I|paroxetine, quinidine, rifamycins (such as rifabutin, rifampin),||
9105|247|I|ritonavir, certain drugs used to treat seizures (such as||
9105|248|I|carbamazepine, phenytoin), among others.||
9105|249|I|   This medication may interfere with certain lab tests (such as||
9105|250|I|urine 5-HIAA/VMA urine screening test, amylase/lipase levels),||
9105|251|I|possibly causing false test results. Make sure lab personnel and||
9105|252|I|all your doctors know you use this drug.||
9105|253|B|||
9105|254|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9105|255|O|as passing out or trouble breathing, give them naloxone or||
9105|256|O|nalmefene if available, then call 911. If the person is awake and||
9105|257|O|has no symptoms, call a poison control center right away. US||
9105|258|O|residents can call 1-800-222-1222. Canada residents can call||
9105|259|O|1-844-764-7669. Symptoms of overdose may include: severe||
9105|260|O|drowsiness/dizziness, slow/shallow breathing, seizures, ringing||
9105|261|O|in the ears, coma.||
9105|262|B|||
9105|263|N|NOTES:  Do not share this medication with others. Sharing it is||
9105|264|N|against the law.||
9105|265|N|   This medication has been prescribed for your current condition||
9105|266|N|only. Do not use it later for another condition unless your||
9105|267|N|doctor directs you to do so. A different medication may be||
9105|268|N|necessary in that case.||
9105|269|B|||
9105|270|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9105|271|D|remember. If it is near the time of the next dose, skip the||
9105|272|D|missed dose. Take your next dose at the regular time. Do not||
9105|273|D|double the dose to catch up.||
9105|274|B|||
9105|275|R|STORAGE:  Store at room temperature away from light and moisture.||
9105|276|R|Do not store in the bathroom. Keep all medications away from||
9105|277|R|children and pets.||
9105|278|R|   Do not flush medications down the toilet or pour them into a||
9105|279|R|drain unless instructed to do so. Properly discard this product||
9105|280|R|when it is expired or no longer needed. Consult your pharmacist||
9105|281|R|or local waste disposal company.||
9105|282|B|||
9105|283|A|Information last revised August 2025.||
9105|284|A|Copyright(c) 2025 First Databank, Inc.||
9105|285|B|||
9106|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9106|002|Z|does NOT have all possible information about this product. This||
9106|003|Z|information does not assure that this product is safe, effective,||
9106|004|Z|or appropriate for you. This information is not individual||
9106|005|Z|medical advice and does not substitute for the advice of your||
9106|006|Z|health care professional. Always ask your health care||
9106|007|Z|professional for complete information about this product and your||
9106|008|Z|specific health needs.||
9106|009|B|||
9106|010|T|VITAMIN D - ORAL||
9106|011|B|||
9106|012|C|COMMON BRAND NAME(S): Calciferol, Drisdol||
9106|013|B|||
9106|014|U|USES:  Vitamin D (ergocalciferol-D2, cholecalciferol-D3,||
9106|015|U|alfacalcidol) is a fat-soluble vitamin that helps your body||
9106|016|U|absorb calcium and phosphorus. Having the right amount of vitamin||
9106|017|U|D, calcium, and phosphorus is important for building and keeping||
9106|018|U|strong bones. Vitamin D is used to treat and prevent bone||
9106|019|U|disorders (such as rickets, osteomalacia). Vitamin D is made by||
9106|020|U|the body when skin is exposed to sunlight. Sunscreen, protective||
9106|021|U|clothing, limited exposure to sunlight, dark skin, and age may||
9106|022|U|prevent getting enough vitamin D from the sun.||
9106|023|U|   Vitamin D with calcium is used to treat or prevent bone loss||
9106|024|U|(osteoporosis). Vitamin D is also used with other medications to||
9106|025|U|treat low levels of calcium or phosphate caused by certain||
9106|026|U|disorders (such as hypoparathyroidism, pseudohypoparathyroidism,||
9106|027|U|familial hypophosphatemia). It may be used in kidney disease to||
9106|028|U|keep calcium levels normal and allow normal bone growth. Vitamin||
9106|029|U|D drops (or other supplements) are given to breastfed infants||
9106|030|U|because breast milk usually has low levels of vitamin D.||
9106|031|B|||
9106|032|H|HOW TO USE:  Take vitamin D by mouth as directed. Vitamin D is||
9106|033|H|best absorbed when taken after a meal but may be taken with or||
9106|034|H|without food. Alfacalcidol is usually taken with food. Follow all||
9106|035|H|directions on the product package. If you have any questions, ask||
9106|036|H|your doctor or pharmacist.||
9106|037|H|   If your doctor has prescribed this medication, take as||
9106|038|H|directed by your doctor. Your dosage is based on your medical||
9106|039|H|condition, amount of sun exposure, diet, age, and response to||
9106|040|H|treatment.||
9106|041|H|   If you are using the liquid form of this medication, carefully||
9106|042|H|measure the dose using a special measuring device/spoon. Do not||
9106|043|H|use a household spoon because you may not get the correct dose.||
9106|044|H|   If you are taking the chewable tablet or wafers, chew the||
9106|045|H|medication thoroughly before swallowing. Do not swallow whole||
9106|046|H|wafers.||
9106|047|H|   If you are taking the rapidly-dissolving tablets, dry your||
9106|048|H|hands before handling the medication. Place each dose on the||
9106|049|H|tongue, allow it to dissolve completely, and then swallow it with||
9106|050|H|saliva or water. You do not need to take this medication with||
9106|051|H|water.||
9106|052|H|   Certain medications (bile acid sequestrants such as||
9106|053|H|cholestyramine/colestipol, mineral oil, orlistat) can decrease||
9106|054|H|the absorption of vitamin D. Take your doses of these medications||
9106|055|H|as far as possible from your doses of vitamin D (at least 2 hours||
9106|056|H|apart, longer if possible). It may be easiest to take vitamin D||
9106|057|H|at bedtime if you are also taking these other medications. Ask||
9106|058|H|your doctor or pharmacist how long you should wait between doses||
9106|059|H|and for help finding a dosing schedule that will work with all||
9106|060|H|your medications.||
9106|061|H|   Take this medication regularly to get the most benefit from||
9106|062|H|it. To help you remember, take it at the same time each day if||
9106|063|H|you are taking it once a day. If you are taking this medication||
9106|064|H|once a week, take it on the same day each week. Mark your||
9106|065|H|calendar with a reminder.||
9106|066|H|   If your doctor has recommended that you follow a special diet||
9106|067|H|(such as a diet high in calcium), it is very important to follow||
9106|068|H|the diet to get the most benefit from this medication and to||
9106|069|H|prevent serious side effects. Do not take other||
9106|070|H|supplements/vitamins unless ordered by your doctor.||
9106|071|H|   If you think you may have a serious medical problem, get||
9106|072|H|medical help right away.||
9106|073|B|||
9106|074|S|SIDE EFFECTS:  Vitamin D at normal doses usually has no side||
9106|075|S|effects. If you have any unusual effects, contact your doctor or||
9106|076|S|pharmacist promptly.||
9106|077|S|   If your doctor has directed you to use this medication,||
9106|078|S|remember that your doctor has judged that the benefit to you is||
9106|079|S|greater than the risk of side effects. Many people using this||
9106|080|S|medication do not have serious side effects.||
9106|081|S|   Too much vitamin D can cause harmful high calcium levels. Tell||
9106|082|S|your doctor right away if any of these signs of high vitamin||
9106|083|S|D/calcium levels occur: nausea/vomiting, constipation, loss of||
9106|084|S|appetite, increased thirst, increased urination, mental/mood||
9106|085|S|changes, unusual tiredness.||
9106|086|S|   A very serious allergic reaction to this drug is rare.||
9106|087|S|However, get medical help right away if you notice any symptoms||
9106|088|S|of a serious allergic reaction, including: rash, itching/swelling||
9106|089|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9106|090|S|breathing.||
9106|091|S|   This is not a complete list of possible side effects. If you||
9106|092|S|notice other effects not listed above, contact your doctor or||
9106|093|S|pharmacist.||
9106|094|S|   In the US -||
9106|095|S|   Call your doctor for medical advice about side effects. You||
9106|096|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9106|097|S|www.fda.gov/medwatch.||
9106|098|S|   In Canada - Call your doctor for medical advice about side||
9106|099|S|effects. You may report side effects to Health Canada at||
9106|100|S|1-866-234-2345.||
9106|101|B|||
9106|102|P|PRECAUTIONS:  Before taking vitamin D, tell your doctor or||
9106|103|P|pharmacist if you are allergic to it; or to other vitamin D||
9106|104|P|products (such as calcitriol); or if you have any other||
9106|105|P|allergies. This product may contain inactive ingredients (such as||
9106|106|P|peanut/soy found in some brands), which can cause allergic||
9106|107|P|reactions or other problems. Talk to your pharmacist for more||
9106|108|P|details.||
9106|109|P|   Before using this medication, tell your doctor or pharmacist||
9106|110|P|your medical history, especially of: high calcium/vitamin D||
9106|111|P|levels (hypercalcemia/hypervitaminosis D), difficulty absorbing||
9106|112|P|nutrition from food (malabsorption syndrome), kidney disease,||
9106|113|P|liver disease.||
9106|114|P|   Liquid products, chewable tablets, or dissolving tablets may||
9106|115|P|contain sugar and/or aspartame. Liquid products may also contain||
9106|116|P|alcohol. Caution is advised if you have diabetes, liver disease,||
9106|117|P|phenylketonuria (PKU), or any other condition that requires you||
9106|118|P|to limit/avoid these substances in your diet. Ask your doctor or||
9106|119|P|pharmacist about using this product safely.||
9106|120|P|   Before having surgery, tell your doctor or dentist about all||
9106|121|P|the products you use (including prescription drugs,||
9106|122|P|nonprescription drugs, and herbal products).||
9106|123|P|   During pregnancy, doses of vitamin D greater than the||
9106|124|P|recommended dietary allowance should be used only when clearly||
9106|125|P|needed. Discuss the risks and benefits with your doctor.||
9106|126|P|   This medication passes into breast milk. Consult your doctor||
9106|127|P|before breastfeeding.||
9106|128|B|||
9106|129|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9106|130|I|medications work or increase your risk for serious side effects.||
9106|131|I|This document does not contain all possible drug interactions.||
9106|132|I|Keep a list of all the products you use (including||
9106|133|I|prescription/nonprescription drugs and herbal products) and share||
9106|134|I|it with your doctor and pharmacist. Do not start, stop, or change||
9106|135|I|the dosage of any medicines without your doctor's approval.||
9106|136|I|   Some products that may interact with this drug include:||
9106|137|I|burosumab, phosphate binders.||
9106|138|I|   Check the labels on all your prescription and||
9106|139|I|nonprescription/herbal products (such as antacids, laxatives,||
9106|140|I|vitamins) because they may contain calcium, magnesium, phosphate,||
9106|141|I|or vitamin D. Ask your pharmacist about using those products||
9106|142|I|safely.||
9106|143|I|   Vitamin D is very similar to calcitriol. Do not use||
9106|144|I|medications containing calcitriol while using vitamin D.||
9106|145|I|   This vitamin may interfere with certain lab tests (such as||
9106|146|I|cholesterol tests), possibly causing false test results. Make||
9106|147|I|sure lab personnel and all your doctors know you use this||
9106|148|I|vitamin.||
9106|149|B|||
9106|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9106|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9106|152|O|poison control center right away. US residents can call||
9106|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9106|154|O|Symptoms of overdose may include: seizures, confusion, irregular||
9106|155|O|heartbeat.||
9106|156|B|||
9106|157|N|NOTES:  Lab and/or medical tests (such as||
9106|158|N|calcium/magnesium/phosphorus levels) should be done while you are||
9106|159|N|taking this medication. Keep all medical and lab appointments.||
9106|160|N|Consult your doctor for more details.||
9106|161|N|   Foods rich in vitamin D include: fortified dairy products,||
9106|162|N|eggs, sardines, cod liver oil, chicken livers, and fatty fish.||
9106|163|B|||
9106|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9106|165|D|remember. If it is near the time of the next dose, skip the||
9106|166|D|missed dose. Take your next dose at the regular time. Do not||
9106|167|D|double the dose to catch up.||
9106|168|B|||
9106|169|R|STORAGE:  Store vitamin D products (except alfacalcidol) at room||
9106|170|R|temperature away from light and moisture. Do not store in the||
9106|171|R|bathroom. Store alfacalcidol drops in the refrigerator. Do not||
9106|172|R|freeze. Keep all medications away from children and pets.||
9106|173|R|   Do not flush medications down the toilet or pour them into a||
9106|174|R|drain unless instructed to do so. Properly discard this product||
9106|175|R|when it is expired or no longer needed. Consult your pharmacist||
9106|176|R|or local waste disposal company.||
9106|177|B|||
9106|178|A|Information last revised July 2025.||
9106|179|A|Copyright(c) 2025 First Databank, Inc.||
9106|180|B|||
9108|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9108|002|Z|does NOT have all possible information about this product. This||
9108|003|Z|information does not assure that this product is safe, effective,||
9108|004|Z|or appropriate for you. This information is not individual||
9108|005|Z|medical advice and does not substitute for the advice of your||
9108|006|Z|health care professional. Always ask your health care||
9108|007|Z|professional for complete information about this product and your||
9108|008|Z|specific health needs.||
9108|009|B|||
9108|010|T|CYCLOSPORINE - ORAL||
9108|011|F|(SYE-kloe-SPOR-in)||
9108|012|B|||
9108|013|C|COMMON BRAND NAME(S): Sandimmune||
9108|014|B|||
9108|015|W|WARNING:  Cyclosporine lowers your ability to fight infections.||
9108|016|W|This may make you more likely to get a serious (rarely fatal)||
9108|017|W|infection or make any infection you have worse. This effect may||
9108|018|W|also increase your risk of getting certain types of cancer (such||
9108|019|W|as skin cancer, lymphoma). Tell your doctor right away if you||
9108|020|W|have any signs of infection or cancer such as sore throat that||
9108|021|W|doesn't go away, fever, chills, burning/frequent urination,||
9108|022|W|unusual skin changes, change in appearance or size of moles,||
9108|023|W|unusual weight loss, swollen lymph nodes, unusual lumps, night||
9108|024|W|sweats.||
9108|025|W|   Cyclosporine can also cause high blood pressure and kidney||
9108|026|W|problems. The risk of both problems increases with higher doses||
9108|027|W|and longer treatment with this drug. Your doctor will monitor||
9108|028|W|your blood pressure and kidney function while you take this||
9108|029|W|medication.||
9108|030|W|   Psoriasis patients who have had certain previous treatments||
9108|031|W|(such as coal tar, methotrexate, radiation treatment, light||
9108|032|W|treatment with PUVA/UVB) are at increased risk to develop skin||
9108|033|W|cancer. Talk to your doctor of the risks and benefits of this||
9108|034|W|medication.||
9108|035|W|   Different brands of this medication may deliver different||
9108|036|W|amounts of medication. Do not switch brands of cyclosporine||
9108|037|W|without your doctor's permission and directions.||
9108|038|B|||
9108|039|U|USES:  Cyclosporine is used to prevent organ rejection in people||
9108|040|U|who have received a liver, kidney, or heart transplant. It is||
9108|041|U|usually taken along with other medications to allow your new||
9108|042|U|organ to function normally. Cyclosporine belongs to a class of||
9108|043|U|drugs known as immunosuppressants. It works by weakening the||
9108|044|U|immune system to help your body accept the new organ as if it||
9108|045|U|were your own.||
9108|046|B|||
9108|047|V|OTHER USES:  This section contains uses of this drug that are not||
9108|048|V|listed in the approved professional labeling for the drug but||
9108|049|V|that may be prescribed by your health care professional. Use this||
9108|050|V|drug for a condition that is listed in this section only if it||
9108|051|V|has been so prescribed by your health care professional.||
9108|052|V|   This drug may also be used to reduce the risk of rejection in||
9108|053|V|other types of organ transplants (such as cornea, pancreas) or||
9108|054|V|bone marrow transplant. It may also be used for other conditions||
9108|055|V|that are affected by the body's immune system (such as Crohn's||
9108|056|V|disease, rheumatoid arthritis, plaque psoriasis).||
9108|057|B|||
9108|058|H|HOW TO USE:  Take this medication by mouth as directed by your||
9108|059|H|doctor, usually once daily. You may take this medication with or||
9108|060|H|without food, but it is important to choose one way and take this||
9108|061|H|medication the same way with every dose.||
9108|062|H|   The dosage is based on your weight, medical condition, lab||
9108|063|H|tests, and response to treatment.||
9108|064|H|   Avoid eating grapefruit or drinking grapefruit juice while||
9108|065|H|using this medication unless your doctor or pharmacist says you||
9108|066|H|may do so safely. Grapefruit can increase the chance of side||
9108|067|H|effects with this medicine. Ask your doctor or pharmacist for||
9108|068|H|more details.||
9108|069|H|   Use this medication regularly to get the most benefit from it.||
9108|070|H|To help you remember, take it at the same time each day.||
9108|071|B|||
9108|072|S|SIDE EFFECTS:  See also Warning section.||
9108|073|S|   Shaking, headache, dizziness, unusual growth of body hair,||
9108|074|S|nausea/vomiting, diarrhea, stomach upset, or flushing may occur.||
9108|075|S|If any of these effects last or get worse, tell your doctor or||
9108|076|S|pharmacist promptly.||
9108|077|S|   Unusual growth and swelling of the gums may occur. Brush your||
9108|078|S|teeth and floss daily to reduce this problem. See your dentist||
9108|079|S|regularly.||
9108|080|S|   Remember that this medication has been prescribed because your||
9108|081|S|doctor has judged that the benefit to you is greater than the||
9108|082|S|risk of side effects. Many people using this medication do not||
9108|083|S|have serious side effects.||
9108|084|S|   This medication may raise your blood pressure. Check your||
9108|085|S|blood pressure regularly and tell your doctor if the results are||
9108|086|S|high. Your doctor may control your blood pressure with||
9108|087|S|medication.||
9108|088|S|   Tell your doctor right away if you have any serious side||
9108|089|S|effects, including: signs of kidney problems (such as a change in||
9108|090|S|the amount of urine), signs of liver disease (such as||
9108|091|S|nausea/vomiting that doesn't stop, dark urine, yellowing||
9108|092|S|eyes/skin, stomach/abdominal pain), easy bruising/bleeding,||
9108|093|S|unusual tiredness, muscle weakness/spasms, slow/irregular||
9108|094|S|heartbeat, numb/tingling skin, severe leg pain.||
9108|095|S|   Get medical help right away if you have any very serious side||
9108|096|S|effects, including: mental/mood changes (such as confusion,||
9108|097|S|difficulty concentrating), vision changes, problems with speech,||
9108|098|S|clumsiness, loss of coordination, weakness on one side of the||
9108|099|S|body, chest pain, seizures.||
9108|100|S|   A very serious allergic reaction to this drug is rare.||
9108|101|S|However, get medical help right away if you notice any symptoms||
9108|102|S|of a serious allergic reaction, including: rash, itching/swelling||
9108|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9108|104|S|breathing.||
9108|105|S|   This is not a complete list of possible side effects. If you||
9108|106|S|notice other effects not listed above, contact your doctor or||
9108|107|S|pharmacist.||
9108|108|S|   In the US -||
9108|109|S|   Call your doctor for medical advice about side effects. You||
9108|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9108|111|S|www.fda.gov/medwatch.||
9108|112|S|   In Canada - Call your doctor for medical advice about side||
9108|113|S|effects. You may report side effects to Health Canada at||
9108|114|S|1-866-234-2345.||
9108|115|B|||
9108|116|P|PRECAUTIONS:  Before taking cyclosporine, tell your doctor or||
9108|117|P|pharmacist if you are allergic to it; or if you have any other||
9108|118|P|allergies. This product may contain inactive ingredients, which||
9108|119|P|can cause allergic reactions or other problems. Talk to your||
9108|120|P|pharmacist for more details.||
9108|121|P|   Before using this medication, tell your doctor or pharmacist||
9108|122|P|your medical history, especially of: kidney disease, liver||
9108|123|P|disease, high blood pressure, cancer, skin lesions of unknown||
9108|124|P|cause, radiation treatment (including light treatment with PUVA||
9108|125|P|or UVB), mineral imbalance (such as low level of magnesium or||
9108|126|P|high level of potassium), recent/current infections, high||
9108|127|P|cholesterol/triglycerides levels.||
9108|128|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9108|129|P|can make you more dizzy. Do not drive, use machinery, or do||
9108|130|P|anything that needs alertness until you can do it safely. Limit||
9108|131|P|alcoholic beverages. Talk to your doctor if you are using||
9108|132|P|marijuana (cannabis).||
9108|133|P|   This medication may contain alcohol. Caution is advised if you||
9108|134|P|are pregnant or breastfeeding or have liver disease, alcohol||
9108|135|P|dependence, or any other condition that requires you to||
9108|136|P|limit/avoid alcohol in your diet. Ask your doctor or pharmacist||
9108|137|P|about using this product safely.||
9108|138|P|   Cyclosporine can make you more likely to get infections or may||
9108|139|P|make current infections worse. Stay away from anyone who has an||
9108|140|P|infection that may easily spread (such as chickenpox, COVID-19,||
9108|141|P|measles, flu). Talk to your doctor if you have been exposed to an||
9108|142|P|infection or for more details.||
9108|143|P|   Tell your health care professional that you are using||
9108|144|P|cyclosporine before having any immunizations/vaccinations. Avoid||
9108|145|P|contact with people who have recently received live vaccines||
9108|146|P|(such as flu vaccine inhaled through the nose).||
9108|147|P|   This medication may increase your risk of developing skin||
9108|148|P|cancer. Limit your time in the sun. Avoid tanning booths and||
9108|149|P|sunlamps. Use sunscreen and wear protective clothing when||
9108|150|P|outdoors. Your doctor may direct you to avoid phototherapy while||
9108|151|P|you use this product. Ask your doctor for details.||
9108|152|P|   This product may increase your potassium levels. Before using||
9108|153|P|potassium supplements or salt substitutes that contain potassium,||
9108|154|P|consult your doctor or pharmacist.||
9108|155|P|   Before having surgery, tell your doctor or dentist about all||
9108|156|P|the products you use (including prescription drugs,||
9108|157|P|nonprescription drugs, and herbal products).||
9108|158|P|   Older adults may be at greater risk for kidney problems or||
9108|159|P|high blood pressure while using this drug.||
9108|160|P|   During pregnancy, this medication should be used only when||
9108|161|P|clearly needed. It may harm an unborn baby or cause other||
9108|162|P|problems with the baby such as being born too early (premature)||
9108|163|P|or having low birth weight. Discuss the risks and benefits with||
9108|164|P|your doctor.||
9108|165|P|   This medication passes into breast milk. Consult your doctor||
9108|166|P|before breastfeeding.||
9108|167|B|||
9108|168|I|DRUG INTERACTIONS:  See also How to Use section.||
9108|169|I|   Drug interactions may change how your medications work or||
9108|170|I|increase your risk for serious side effects. This document does||
9108|171|I|not contain all possible drug interactions. Keep a list of all||
9108|172|I|the products you use (including prescription/nonprescription||
9108|173|I|drugs and herbal products) and share it with your doctor and||
9108|174|I|pharmacist. Do not start, stop, or change the dosage of any||
9108|175|I|medicines without your doctor's approval.||
9108|176|I|   Some products that may interact with this drug include: coal||
9108|177|I|tar, orlistat, other drugs that weaken the immune system/increase||
9108|178|I|the risk of infection (such as natalizumab, rituximab,||
9108|179|I|tofacitinib), drugs that may increase potassium levels (such as||
9108|180|I|potassium supplements, certain diuretics/"water pills" including||
9108|181|I|amiloride, spironolactone), tacrolimus.||
9108|182|I|   Other medications can affect the removal of cyclosporine from||
9108|183|I|your body, which may affect how cyclosporine works. Examples||
9108|184|I|include bosentan, mifepristone, St. John's wort, ritonavir, among||
9108|185|I|others.||
9108|186|I|   This medication can slow down the removal of other medications||
9108|187|I|from your body, which may affect how they work. Examples of||
9108|188|I|affected drugs include aliskiren, dabigatran, dronedarone,||
9108|189|I|elagolix, resmetirom, certain statins (such as pitavastatin,||
9108|190|I|simvastatin), voxilaprevir, among others.||
9108|191|B|||
9108|192|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9108|193|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9108|194|O|poison control center right away. US residents can call||
9108|195|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9108|196|B|||
9108|197|N|NOTES:  Do not share this medication with others.||
9108|198|N|   Lab and/or medical tests (such as kidney/liver function, blood||
9108|199|N|pressure, blood mineral levels, cyclosporine blood levels,||
9108|200|N|complete blood count, uric acid levels, lipid levels, skin exam)||
9108|201|N|should be done while you are taking this medication. Keep all||
9108|202|N|medical and lab appointments. Consult your doctor for more||
9108|203|N|details.||
9108|204|N|   If you have had an organ transplant, it is recommended that||
9108|205|N|you attend a transplant education class or support group. Learn||
9108|206|N|the symptoms of organ rejection such as a feeling of being ill,||
9108|207|N|fever, pain around the transplanted organ, and signs of a failing||
9108|208|N|transplanted organ (a decrease in the amount of urine with kidney||
9108|209|N|transplant, yellowing of the skin/eyes with liver transplant,||
9108|210|N|shortness of breath/inability to exercise with heart transplant).||
9108|211|N|Get medical help right away if these symptoms of rejection occur.||
9108|212|B|||
9108|213|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9108|214|D|remember. If it is near the time of the next dose, skip the||
9108|215|D|missed dose. Take your next dose at the regular time. Do not||
9108|216|D|double the dose to catch up.||
9108|217|B|||
9108|218|R|STORAGE:  Store in the original blister pack at room temperature||
9108|219|R|away from heat and moisture. Do not store in the bathroom. Keep||
9108|220|R|all medications away from children and pets.||
9108|221|R|   Do not flush medications down the toilet or pour them into a||
9108|222|R|drain unless instructed to do so. Properly discard this product||
9108|223|R|when it is expired or no longer needed. Consult your pharmacist||
9108|224|R|or local waste disposal company.||
9108|225|B|||
9108|226|M|MEDICAL ALERT:  Your condition can cause complications in a||
9108|227|M|medical emergency. For information about enrolling in MedicAlert,||
9108|228|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9108|229|B|||
9108|230|A|Information last revised May 2025.||
9108|231|A|Copyright(c) 2025 First Databank, Inc.||
9108|232|B|||
9109|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9109|002|Z|does NOT have all possible information about this product. This||
9109|003|Z|information does not assure that this product is safe, effective,||
9109|004|Z|or appropriate for you. This information is not individual||
9109|005|Z|medical advice and does not substitute for the advice of your||
9109|006|Z|health care professional. Always ask your health care||
9109|007|Z|professional for complete information about this product and your||
9109|008|Z|specific health needs.||
9109|009|B|||
9109|010|T|DOCUSATE - ORAL||
9109|011|F|(DOCK-you-sate)||
9109|012|B|||
9109|013|C|COMMON BRAND NAME(S): Col-Rite, Colace, Correctol, Diocto,||
9109|014|C|Doc-Q-Lace, Docusoft, DSS, Silace, Surfak||
9109|015|B|||
9109|016|U|USES:  This medication is used to treat occasional constipation.||
9109|017|U|Some medications and conditions can make constipation more||
9109|018|U|likely. Stool softeners such as docusate are often the first||
9109|019|U|method used for preventing and treating this type of||
9109|020|U|constipation. Docusate is often used when straining to have a||
9109|021|U|bowel movement should be avoided (such as after a heart attack or||
9109|022|U|surgery).||
9109|023|U|   Docusate is a stool softener. It works by increasing the||
9109|024|U|amount of water the stool absorbs in the gut, making the stool||
9109|025|U|softer and easier to pass. Relief is usually seen in 1 to 3 days||
9109|026|U|with this medication.||
9109|027|U|   Check the ingredients on the label even if you have used the||
9109|028|U|product before. The manufacturer may have changed the||
9109|029|U|ingredients. Also, products with similar names may contain||
9109|030|U|different ingredients meant for different purposes. Taking the||
9109|031|U|wrong product could harm you.||
9109|032|B|||
9109|033|H|HOW TO USE:  If you are taking the over-the-counter product to||
9109|034|H|self-treat, read and follow all directions on the product package||
9109|035|H|before taking this medication. If you have any questions, consult||
9109|036|H|your pharmacist. If your doctor has prescribed this medication,||
9109|037|H|take it as directed.||
9109|038|H|   Take this medication by mouth, usually at bedtime with a full||
9109|039|H|glass (8 ounces or 240 milliliters) of water or juice, or as||
9109|040|H|directed by your doctor. The dosage is based on your medical||
9109|041|H|condition, age, and response to treatment.||
9109|042|H|   If you are using the liquid form of this medication, measure||
9109|043|H|the dose carefully using a special measuring device/spoon. Do not||
9109|044|H|use a household spoon because you may not get the correct dose.||
9109|045|H|If you are using the drops, measure the medication with the||
9109|046|H|dropper provided, or use a dose-measuring spoon or device to make||
9109|047|H|sure you have the correct dose. Mix the syrup, liquid or drops in||
9109|048|H|4 to 8 ounces of fruit juice, milk or infant formula to prevent||
9109|049|H|throat irritation and mask a bitter taste.||
9109|050|H|   Use this medication only when needed. Do not use this product||
9109|051|H|for more than 1 week unless directed by your doctor.||
9109|052|H|   Do not increase your dose or take this drug more often or for||
9109|053|H|longer than directed. Your condition will not improve any faster,||
9109|054|H|and your risk of side effects will increase.||
9109|055|H|   If your condition lasts or gets worse, or if you think you may||
9109|056|H|have a serious medical problem, get medical help right away.||
9109|057|B|||
9109|058|S|SIDE EFFECTS:  Stomach pain, diarrhea, or cramping may occur.||
9109|059|S|Irritated throat (with liquid or syrup forms) may also occur. If||
9109|060|S|any of these effects last or get worse, tell your doctor or||
9109|061|S|pharmacist promptly.||
9109|062|S|   If your doctor has directed you to use this medication,||
9109|063|S|remember that your doctor has judged that the benefit to you is||
9109|064|S|greater than the risk of side effects. Many people using this||
9109|065|S|medication do not have serious side effects.||
9109|066|S|   Tell your doctor right away if you have any serious side||
9109|067|S|effects, including: rectal bleeding.||
9109|068|S|   A very serious allergic reaction to this drug is rare.||
9109|069|S|However, get medical help right away if you notice any symptoms||
9109|070|S|of a serious allergic reaction, including: rash, itching/swelling||
9109|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9109|072|S|breathing.||
9109|073|S|   This is not a complete list of possible side effects. If you||
9109|074|S|notice other effects not listed above, contact your doctor or||
9109|075|S|pharmacist.||
9109|076|S|   In the US -||
9109|077|S|   Call your doctor for medical advice about side effects. You||
9109|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9109|079|S|www.fda.gov/medwatch.||
9109|080|S|   In Canada - Call your doctor for medical advice about side||
9109|081|S|effects. You may report side effects to Health Canada at||
9109|082|S|1-866-234-2345.||
9109|083|B|||
9109|084|P|PRECAUTIONS:  Before taking docusate, tell your doctor or||
9109|085|P|pharmacist if you are allergic to it or if you have any other||
9109|086|P|allergies. This product may contain inactive ingredients, which||
9109|087|P|can cause allergic reactions or other problems. Talk to your||
9109|088|P|pharmacist for more details.||
9109|089|P|   If you have any of the following health problems, consult your||
9109|090|P|doctor or pharmacist before using this medication: severe||
9109|091|P|abdominal pain, nausea, vomiting, sudden change in bowel habits||
9109|092|P|over the previous 2 weeks.||
9109|093|P|   Before having surgery, tell your doctor or dentist about all||
9109|094|P|the products you use (including prescription drugs,||
9109|095|P|nonprescription drugs, and herbal products).||
9109|096|P|   Tell your doctor if you are pregnant before using this||
9109|097|P|medication.||
9109|098|P|   It is unknown if this medication passes into breast milk.||
9109|099|P|Consult your doctor before breastfeeding.||
9109|100|B|||
9109|101|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9109|102|I|medications work or increase your risk for serious side effects.||
9109|103|I|This document does not contain all possible drug interactions.||
9109|104|I|Keep a list of all the products you use (including||
9109|105|I|prescription/nonprescription drugs and herbal products) and share||
9109|106|I|it with your doctor and pharmacist. Do not start, stop, or change||
9109|107|I|the dosage of any medicines without your doctor's approval.||
9109|108|I|   A product that may interact with this drug is: mineral oil.||
9109|109|B|||
9109|110|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9109|111|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9109|112|O|poison control center right away. US residents can call||
9109|113|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9109|114|B|||
9109|115|N|NOTES:  Do not share this medication with others.||
9109|116|N|   Keep all medical and lab appointments.||
9109|117|N|   To prevent constipation, eat dietary fiber, drink enough||
9109|118|N|water, and exercise. Use this medication for temporary relief of||
9109|119|N|constipation only. To prevent becoming dependent on laxatives, do||
9109|120|N|not take this medication for a long period of time.||
9109|121|B|||
9109|122|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9109|123|D|If it is near the time of the next dose, skip the missed dose.||
9109|124|D|Use your next dose at the regular time. Do not double the dose to||
9109|125|D|catch up.||
9109|126|B|||
9109|127|R|STORAGE:  Store at room temperature away from light and moisture.||
9109|128|R|Do not store in the bathroom. Keep all medications away from||
9109|129|R|children and pets.||
9109|130|R|   Do not flush medications down the toilet or pour them into a||
9109|131|R|drain unless instructed to do so. Properly discard this product||
9109|132|R|when it is expired or no longer needed. Consult your pharmacist||
9109|133|R|or local waste disposal company.||
9109|134|B|||
9109|135|A|Information last revised May 2024.||
9109|136|A|Copyright(c) 2025 First Databank, Inc.||
9109|137|B|||
9112|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9112|002|Z|does NOT have all possible information about this product. This||
9112|003|Z|information does not assure that this product is safe, effective,||
9112|004|Z|or appropriate for you. This information is not individual||
9112|005|Z|medical advice and does not substitute for the advice of your||
9112|006|Z|health care professional. Always ask your health care||
9112|007|Z|professional for complete information about this product and your||
9112|008|Z|specific health needs.||
9112|009|B|||
9112|010|T|DESMOPRESSIN 0.1 MG/ML SPRAY - NASAL (REFRIGERATE)||
9112|011|F|(dess-mow-PRESS-in)||
9112|012|B|||
9112|013|C|COMMON BRAND NAME(S): DDAVP||
9112|014|B|||
9112|015|W|WARNING:  Desmopressin can rarely cause a low level of sodium in||
9112|016|W|the blood (hyponatremia), which can be serious or even fatal.||
9112|017|W|Drinking too much liquid, using certain medications (such as||
9112|018|W|"water pills"/diuretics including furosemide, corticosteroids||
9112|019|W|such as prednisone), being 65 years or older, or having certain||
9112|020|W|medical conditions may increase the risk of low sodium in the||
9112|021|W|blood. Lab tests (such as urine tests, sodium blood levels) must||
9112|022|W|be done before you start using this medication and while you are||
9112|023|W|using it. Keep all medical and lab appointments.||
9112|024|W|   Tell your doctor right away if you develop symptoms of low||
9112|025|W|sodium in the blood, such as nausea, vomiting, headache, muscle||
9112|026|W|weakness/cramps, unusual tiredness, unusual drowsiness,||
9112|027|W|dizziness, restlessness, mental/mood changes including||
9112|028|W|confusion/irritability.||
9112|029|W|   Get medical help right away if you have any very serious side||
9112|030|W|effects, including seizure or trouble breathing.||
9112|031|B|||
9112|032|U|USES:  Desmopressin is used to control the amount of urine your||
9112|033|U|kidneys make. Normally, the amount of urine you make is||
9112|034|U|controlled by a certain substance in the body called vasopressin.||
9112|035|U|In people who have "water diabetes" (diabetes insipidus) or||
9112|036|U|certain kinds of head injury or brain surgery, the body does not||
9112|037|U|make enough vasopressin. Desmopressin is a man-made form of||
9112|038|U|vasopressin and is used to replace a low level of vasopressin.||
9112|039|U|This medication helps to control increased thirst and too much||
9112|040|U|urination due to these conditions, and helps prevent dehydration.||
9112|041|U|   Desmopressin products applied in the nose are no longer||
9112|042|U|indicated to control nighttime bedwetting in children because of||
9112|043|U|the increased risk of developing a serious side effect (a low||
9112|044|U|level of sodium in the blood).||
9112|045|B|||
9112|046|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9112|047|H|from your pharmacist and the patient instruction sheet that come||
9112|048|H|with this product before you start using desmopressin and each||
9112|049|H|time you get a refill. If you have any questions, consult your||
9112|050|H|doctor or pharmacist.||
9112|051|H|   Follow the instructions on how to properly prime the bottle if||
9112|052|H|you are using it for the first time or if you have not used it||
9112|053|H|for a week or more. Spray this medication in the nose, usually 1||
9112|054|H|to 3 times a day as directed by your doctor. If the dose is more||
9112|055|H|than 1 spray, spray half the dose in each nostril. For example,||
9112|056|H|if the dose is 2 sprays, give 1 spray in each nostril.||
9112|057|H|   Keep track of the number of sprays used from each container.||
9112|058|H|Discard the container after you have used the number of sprays||
9112|059|H|specified on the package.||
9112|060|H|   If a child is using this medication, a parent or other||
9112|061|H|responsible adult should supervise and help the child use this||
9112|062|H|medication properly.||
9112|063|H|   Limit drinking of water and other fluids while using this||
9112|064|H|medication, especially in children and older adults. Consult your||
9112|065|H|doctor for details. If you find that you are drinking more fluids||
9112|066|H|than directed, tell your doctor right away. Your treatment will||
9112|067|H|need to be adjusted.||
9112|068|H|   Dosage is based on your medical condition and response to||
9112|069|H|treatment. Do not use more desmopressin or use it more often than||
9112|070|H|prescribed.||
9112|071|H|   Use this medication regularly to get the most benefit from it.||
9112|072|H|To help you remember, use it at the same time(s) each day.||
9112|073|H|   Tell your doctor if your condition does not get better or if||
9112|074|H|this medication stops working well.||
9112|075|B|||
9112|076|S|SIDE EFFECTS:  See also Warning section.||
9112|077|S|   Headache, runny/stuffy nose, nausea, upset stomach, or||
9112|078|S|flushing of the face may occur. If any of these effects last or||
9112|079|S|get worse, tell your doctor or pharmacist promptly.||
9112|080|S|   Remember that this medication has been prescribed because your||
9112|081|S|doctor has judged that the benefit to you is greater than the||
9112|082|S|risk of side effects. Many people using this medication do not||
9112|083|S|have serious side effects.||
9112|084|S|   A very serious allergic reaction to this drug is rare.||
9112|085|S|However, get medical help right away if you notice any symptoms||
9112|086|S|of a serious allergic reaction, including: rash, itching/swelling||
9112|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9112|088|S|breathing.||
9112|089|S|   This is not a complete list of possible side effects. If you||
9112|090|S|notice other effects not listed above, contact your doctor or||
9112|091|S|pharmacist.||
9112|092|S|   In the US -||
9112|093|S|   Call your doctor for medical advice about side effects. You||
9112|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9112|095|S|www.fda.gov/medwatch.||
9112|096|S|   In Canada - Call your doctor for medical advice about side||
9112|097|S|effects. You may report side effects to Health Canada at||
9112|098|S|1-866-234-2345.||
9112|099|B|||
9112|100|P|PRECAUTIONS:  Before using desmopressin, tell your doctor or||
9112|101|P|pharmacist if you are allergic to it; or if you have any other||
9112|102|P|allergies. This product may contain inactive ingredients, which||
9112|103|P|can cause allergic reactions or other problems. Talk to your||
9112|104|P|pharmacist for more details.||
9112|105|P|   Before using this medication, tell your doctor or pharmacist||
9112|106|P|your medical history, especially of: kidney disease, high blood||
9112|107|P|pressure, heart problems (such as blocked blood vessels, heart||
9112|108|P|failure), conditions that may increase your risk of fluid/mineral||
9112|109|P|imbalance (such as cystic fibrosis), the urge to drink too much||
9112|110|P|water without being thirsty, a low level of sodium in the blood||
9112|111|P|(hyponatremia), bleeding/clotting problems.||
9112|112|P|   If you become dehydrated, your doctor will correct that||
9112|113|P|condition first before starting treatment with desmopressin.||
9112|114|P|   Limit alcohol because it can interfere with how well||
9112|115|P|desmopressin works.||
9112|116|P|   Changes inside the nose (such as scarring, swelling,||
9112|117|P|congestion, or blockage) may affect how well desmopressin is||
9112|118|P|absorbed. Tell your doctor if you have any of these changes||
9112|119|P|inside the nose because your doctor may need to adjust your||
9112|120|P|treatment.||
9112|121|P|   Tell the doctor right away if you develop any illness that can||
9112|122|P|cause water/mineral imbalance (including fever, diarrhea,||
9112|123|P|vomiting, infections such as the flu) or if you experience||
9112|124|P|conditions that require drinking more fluids (for example,||
9112|125|P|exposure to very hot weather, strenuous exercise, heavy||
9112|126|P|sweating). The doctor may need to stop or adjust desmopressin||
9112|127|P|treatment, especially in children and older adults.||
9112|128|P|   Children may be more sensitive to the side effects of this||
9112|129|P|drug, especially water/mineral imbalance and a low level of||
9112|130|P|sodium in the blood.||
9112|131|P|   Older adults may be at greater risk for water/mineral||
9112|132|P|imbalance and a low level of sodium in the blood while using this||
9112|133|P|drug.||
9112|134|P|   During pregnancy, this medication should be used only when||
9112|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
9112|136|P|   This medication passes into breast milk. Consult your doctor||
9112|137|P|before breastfeeding.||
9112|138|B|||
9112|139|I|DRUG INTERACTIONS:  See also Warning section.||
9112|140|I|   Drug interactions may change how your medications work or||
9112|141|I|increase your risk for serious side effects. This document does||
9112|142|I|not contain all possible drug interactions. Keep a list of all||
9112|143|I|the products you use (including prescription/nonprescription||
9112|144|I|drugs and herbal products) and share it with your doctor and||
9112|145|I|pharmacist. Do not start, stop, or change the dosage of any||
9112|146|I|medicines without your doctor's approval.||
9112|147|I|   Some products that may interact with this drug are:||
9112|148|I|corticosteroids that are taken by mouth or inhaled (such as||
9112|149|I|fluticasone, prednisone), tolvaptan, "water pills"/diuretics||
9112|150|I|(such as furosemide).||
9112|151|B|||
9112|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9112|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9112|154|O|poison control center right away. US residents can call||
9112|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9112|156|O|Symptoms of overdose may include: headache that is severe or||
9112|157|O|doesn't go away, confusion, drowsiness, sudden weight gain.||
9112|158|B|||
9112|159|N|NOTES:  Do not share this medication with others.||
9112|160|N|   Lab and/or medical tests (such as urine tests, sodium blood||
9112|161|N|level) may be done while you are using this medication. Keep all||
9112|162|N|medical and lab appointments. Consult your doctor for more||
9112|163|N|details.||
9112|164|B|||
9112|165|D|MISSED DOSE:  If you use 1 dose daily and miss a dose, use it as||
9112|166|D|soon as you remember. If you do not remember until the next day,||
9112|167|D|skip the missed dose. Use your next dose at the regular time. Do||
9112|168|D|not double the dose to catch up.||
9112|169|D|   If you use more than 1 dose daily and miss a dose, use it as||
9112|170|D|soon as you remember. If it is near the time of the next dose,||
9112|171|D|skip the missed dose. Use your next dose at the regular time. Do||
9112|172|D|not double the dose to catch up.||
9112|173|B|||
9112|174|R|STORAGE:  Store upright in the refrigerator. This medication may||
9112|175|R|also be stored at room temperature if needed. If the medication||
9112|176|R|is stored at room temperature, discard after 3 weeks. Keep all||
9112|177|R|medications away from children and pets.||
9112|178|R|   Do not flush medications down the toilet or pour them into a||
9112|179|R|drain unless instructed to do so. Properly discard this product||
9112|180|R|when it is expired or no longer needed. Consult your pharmacist||
9112|181|R|or local waste disposal company.||
9112|182|B|||
9112|183|A|Information last revised November 2024.||
9112|184|A|Copyright(c) 2025 First Databank, Inc.||
9112|185|B|||
9115|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9115|002|Z|does NOT have all possible information about this product. This||
9115|003|Z|information does not assure that this product is safe, effective,||
9115|004|Z|or appropriate for you. This information is not individual||
9115|005|Z|medical advice and does not substitute for the advice of your||
9115|006|Z|health care professional. Always ask your health care||
9115|007|Z|professional for complete information about this product and your||
9115|008|Z|specific health needs.||
9115|009|B|||
9115|010|T|NORGESTREL (CONTRACEPTIVE) - ORAL||
9115|011|F|(nor-JES-trel)||
9115|012|B|||
9115|013|C|COMMON BRAND NAME(S): Opill||
9115|014|B|||
9115|015|U|USES:  This medication is used to prevent pregnancy. It contains||
9115|016|U|the hormone norgestrel (a progestin). It works by making vaginal||
9115|017|U|fluid thicker to help prevent sperm from reaching an egg||
9115|018|U|(fertilization). It may also prevent the release of an egg||
9115|019|U|(ovulation) during some menstrual cycles.||
9115|020|U|   This medication is not an emergency contraceptive and will not||
9115|021|U|prevent pregnancy when used after unprotected sex. Using this||
9115|022|U|medication will not stop an existing pregnancy.||
9115|023|U|   This drug does not protect against sexually transmitted||
9115|024|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
9115|025|U|an effective barrier method (latex or polyurethane condom/dental||
9115|026|U|dams) during sexual activity will help to decrease your risk of||
9115|027|U|infection.||
9115|028|B|||
9115|029|H|HOW TO USE:  If you are using the over-the-counter product to||
9115|030|H|self-treat, read all directions on the product package before||
9115|031|H|using this medication. If you have any questions, consult your||
9115|032|H|pharmacist. If your doctor has prescribed this medication, use it||
9115|033|H|as directed.||
9115|034|H|   Take this medication by mouth with or without food, once||
9115|035|H|daily. Pick a time of day that is easy for you to remember, and||
9115|036|H|take your pill at the same time each day.||
9115|037|H|   It is very important to keep taking this medication exactly as||
9115|038|H|directed on the product package. Do not skip any doses. Pregnancy||
9115|039|H|is more likely if you miss pills, start a new pack late, or take||
9115|040|H|your pill at a different time of the day than usual.||
9115|041|H|   If you have vomiting or diarrhea within 4 hours after taking||
9115|042|H|your tablet, follow the directions in the product package for||
9115|043|H|what to do if you miss a dose and use a backup form of birth||
9115|044|H|control (such as condoms, spermicide) for 48 hours.||
9115|045|H|   Taking this medication after your evening meal or at bedtime||
9115|046|H|may help if you have stomach upset or nausea with the medication.||
9115|047|H|You may choose to take this medication at another time of day||
9115|048|H|that is easier for you to remember. No matter what dosing||
9115|049|H|schedule you use, it is very important that you take this||
9115|050|H|medication at the same time each day, 24 hours apart.||
9115|051|H|   Keep taking one tablet every day. After taking the last tablet||
9115|052|H|in your existing pack, start a new pack the next day. Your||
9115|053|H|periods may be early or late, shorter or longer, heavier or||
9115|054|H|lighter than normal. You may also have some spotting between||
9115|055|H|periods. Do not stop taking your pills if this happens.||
9115|056|H|   If this is the first time you are using this medication and||
9115|057|H|you are not switching from another form of hormonal birth control||
9115|058|H|(such as patch, other birth control pills), use a backup form of||
9115|059|H|non-hormonal birth control (such as condoms, spermicide) for the||
9115|060|H|first 48 hours to prevent pregnancy until the medication has||
9115|061|H|enough time to work.||
9115|062|H|   Ask your doctor or pharmacist for information about how to||
9115|063|H|switch from other forms of hormonal birth control (such as patch,||
9115|064|H|other birth control pills) to this product. If any information is||
9115|065|H|unclear, consult the package instructions or your doctor or||
9115|066|H|pharmacist.||
9115|067|B|||
9115|068|S|SIDE EFFECTS:  See also How to Use section.||
9115|069|S|   Nausea, vomiting, increased appetite, stomach||
9115|070|S|cramping/bloating, dizziness, or headache may occur. Vaginal||
9115|071|S|bleeding between periods (spotting) or missed/irregular periods||
9115|072|S|may occur, especially during the first few months of use. If any||
9115|073|S|of these effects last or get worse, tell your doctor or||
9115|074|S|pharmacist promptly. If you miss 2 periods in a row (or 1 period||
9115|075|S|if the pill has not been used properly), take a pregnancy test or||
9115|076|S|contact your doctor.||
9115|077|S|   If your doctor has directed you to use this medication,||
9115|078|S|remember that your doctor has judged that the benefit to you is||
9115|079|S|greater than the risk of side effects. Many people using this||
9115|080|S|medication do not have serious side effects.||
9115|081|S|   Tell your doctor right away if you have any serious side||
9115|082|S|effects, including: lumps in the breast, mental/mood changes||
9115|083|S|(such as new/worsening depression), unusual changes in vaginal||
9115|084|S|bleeding (such as continuous spotting, sudden heavy bleeding).||
9115|085|S|   Get medical help right away if you have any very serious side||
9115|086|S|effects, including: severe pain/discomfort in the abdomen/groin,||
9115|087|S|loss of appetite, yellowing eyes/skin, dark urine.||
9115|088|S|   A very serious allergic reaction to this drug is rare.||
9115|089|S|However, get medical help right away if you notice any symptoms||
9115|090|S|of a serious allergic reaction, including: rash, itching/swelling||
9115|091|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9115|092|S|breathing.||
9115|093|S|   This is not a complete list of possible side effects. If you||
9115|094|S|notice other effects not listed above, contact your doctor or||
9115|095|S|pharmacist.||
9115|096|S|   In the US -||
9115|097|S|   Call your doctor for medical advice about side effects. You||
9115|098|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9115|099|S|www.fda.gov/medwatch.||
9115|100|S|   In Canada - Call your doctor for medical advice about side||
9115|101|S|effects. You may report side effects to Health Canada at||
9115|102|S|1-866-234-2345.||
9115|103|B|||
9115|104|P|PRECAUTIONS:  Before taking norgestrel, tell your doctor or||
9115|105|P|pharmacist if you are allergic to it; or to other progestins||
9115|106|P|(such as norethindrone); or if you have any other allergies. This||
9115|107|P|product may contain inactive ingredients (such as tartrazine),||
9115|108|P|which can cause allergic reactions or other problems. Talk to||
9115|109|P|your pharmacist for more details.||
9115|110|P|   If you have any of the following health problems, consult your||
9115|111|P|doctor or pharmacist before using this medication: abnormal||
9115|112|P|breast exam, cancer (especially breast cancer), diabetes,||
9115|113|P|depression, severe headaches/migraines, history of yellowing||
9115|114|P|eyes/skin (jaundice) during pregnancy or while using hormonal||
9115|115|P|birth control (such as pills, patch), liver disease (including||
9115|116|P|tumors), unexplained vaginal bleeding.||
9115|117|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9115|118|P|can make you more dizzy. Do not drive, use machinery, or do||
9115|119|P|anything that needs alertness until you can do it safely. Limit||
9115|120|P|alcoholic beverages. Talk to your doctor if you are using||
9115|121|P|marijuana (cannabis).||
9115|122|P|   Before having surgery, tell your doctor or dentist about all||
9115|123|P|the products you use (including prescription drugs,||
9115|124|P|nonprescription drugs, and herbal products).||
9115|125|P|   This medication must not be used during pregnancy. If you||
9115|126|P|become pregnant or think you may be pregnant, tell your doctor||
9115|127|P|right away. If you have just given birth or had a pregnancy loss||
9115|128|P|or abortion after the first 3 months, talk with your doctor about||
9115|129|P|reliable forms of birth control, and find out when it is safe to||
9115|130|P|start using birth control, such as this medication.||
9115|131|P|   A small amount of this medication passes into breast milk but||
9115|132|P|is unlikely to harm a nursing infant. Consult your doctor before||
9115|133|P|breastfeeding.||
9115|134|B|||
9115|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9115|136|I|medications work or increase your risk for serious side effects.||
9115|137|I|This document does not contain all possible drug interactions.||
9115|138|I|Keep a list of all the products you use (including||
9115|139|I|prescription/nonprescription drugs and herbal products) and share||
9115|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
9115|141|I|the dosage of any medicines without your doctor's approval.||
9115|142|I|   Some products that may interact with this drug are: acitretin,||
9115|143|I|alitretinoin, isotretinoin, ulipristal.||
9115|144|I|   Some drugs may cause hormonal birth control to work less well||
9115|145|I|by decreasing the amount of birth control hormones in your body.||
9115|146|I|This effect can result in pregnancy. Examples include||
9115|147|I|griseofulvin, modafinil, rifamycins (such as rifampin,||
9115|148|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
9115|149|I|as barbiturates, carbamazepine, felbamate, phenytoin, primidone,||
9115|150|I|topiramate), HIV drugs (such as nelfinavir, nevirapine,||
9115|151|I|ritonavir), among others.||
9115|152|I|   Tell your doctor when you start any new drug, and discuss if||
9115|153|I|you should use reliable backup birth control. Also tell your||
9115|154|I|doctor if you have any new spotting or breakthrough bleeding,||
9115|155|I|because these may be signs that your birth control is not working||
9115|156|I|well.||
9115|157|I|   This medication may interfere with certain lab tests, possibly||
9115|158|I|causing false test results. Make sure lab personnel and all your||
9115|159|I|doctors know you use this drug.||
9115|160|B|||
9115|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9115|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9115|163|O|poison control center right away. US residents can call||
9115|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9115|165|O|Symptoms of overdose may include: severe nausea and vomiting,||
9115|166|O|sudden/unusual vaginal bleeding.||
9115|167|B|||
9115|168|N|NOTES:  Keep all medical and lab appointments.||
9115|169|B|||
9115|170|D|MISSED DOSE:  Refer to the product package information for advice||
9115|171|D|on missed doses. You may need to use backup birth control (such||
9115|172|D|as condoms, spermicide) to prevent pregnancy. Ask your doctor or||
9115|173|D|pharmacist if you have any questions.||
9115|174|D|   If you often forget to take your pills as directed, contact||
9115|175|D|your doctor to discuss switching to another form of birth||
9115|176|D|control.||
9115|177|B|||
9115|178|R|STORAGE:  Store at room temperature away from light and moisture.||
9115|179|R|Do not store in the bathroom. Keep all medications away from||
9115|180|R|children and pets.||
9115|181|R|   Do not flush medications down the toilet or pour them into a||
9115|182|R|drain unless instructed to do so. Properly discard this product||
9115|183|R|when it is expired or no longer needed. Consult your pharmacist||
9115|184|R|or local waste disposal company.||
9115|185|B|||
9115|186|A|Information last revised October 2025.||
9115|187|A|Copyright(c) 2025 First Databank, Inc.||
9115|188|B|||
9116|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9116|002|Z|does NOT have all possible information about this product. This||
9116|003|Z|information does not assure that this product is safe, effective,||
9116|004|Z|or appropriate for you. This information is not individual||
9116|005|Z|medical advice and does not substitute for the advice of your||
9116|006|Z|health care professional. Always ask your health care||
9116|007|Z|professional for complete information about this product and your||
9116|008|Z|specific health needs.||
9116|009|B|||
9116|010|T|METHYLTESTOSTERONE - ORAL||
9116|011|F|(METH-ill-tess-TOSS-ter-own)||
9116|012|B|||
9116|013|C|COMMON BRAND NAME(S): Android, Testred||
9116|014|B|||
9116|015|U|USES:  This medication is used in men who do not make enough of a||
9116|016|U|natural substance called testosterone. In males, testosterone is||
9116|017|U|responsible for many normal functions, including growth and||
9116|018|U|development of the genitals, muscles, and bones. It also helps||
9116|019|U|cause normal sexual development (puberty) in boys.||
9116|020|U|Methyltestosterone is similar to the natural testosterone||
9116|021|U|produced by your body. It belongs to a class of drugs known as||
9116|022|U|androgens. It works by affecting many body systems so that the||
9116|023|U|body can develop and function normally.||
9116|024|U|   Methyltestosterone may also be used in certain adolescent boys||
9116|025|U|to cause puberty in those with delayed puberty. It may also be||
9116|026|U|used to treat certain types of breast cancer in women.||
9116|027|B|||
9116|028|H|HOW TO USE:  Take this medication by mouth with or without food||
9116|029|H|as directed by your doctor, usually 1 to 4 times a day. The||
9116|030|H|dosage is based on your medical condition, testosterone blood||
9116|031|H|levels, and response to treatment.||
9116|032|H|   Use this medication regularly in order to get the most benefit||
9116|033|H|from it. To help you remember, take it at the same times each||
9116|034|H|day.||
9116|035|H|   Misuse or abuse of testosterone or testosterone-like products||
9116|036|H|can cause serious side effects such as heart disease (including||
9116|037|H|heart attack), stroke, liver disease, mental/mood problems,||
9116|038|H|abnormal drug-seeking behavior, or improper bone growth (in||
9116|039|H|adolescents). Do not increase your dose or use this drug more||
9116|040|H|often or for longer than prescribed. When testosterone is misused||
9116|041|H|or abused, you may have withdrawal symptoms (such as depression,||
9116|042|H|irritability, tiredness) when you suddenly stop using the drug.||
9116|043|H|These symptoms may last from weeks to months.||
9116|044|H|   Tell your doctor if your condition does not get better or if||
9116|045|H|it gets worse.||
9116|046|B|||
9116|047|S|SIDE EFFECTS:  Nausea, vomiting, headache, skin color changes,||
9116|048|S|increased/decreased sexual interest, oily skin, hair loss, and||
9116|049|S|acne may occur. If any of these effects last or get worse, tell||
9116|050|S|your doctor or pharmacist promptly.||
9116|051|S|   Remember that this medication has been prescribed because your||
9116|052|S|doctor has judged that the benefit to you is greater than the||
9116|053|S|risk of side effects. Many people using this medication do not||
9116|054|S|have serious side effects.||
9116|055|S|   This medication may raise your blood pressure. Check your||
9116|056|S|blood pressure regularly and tell your doctor if the results are||
9116|057|S|high. Your doctor may control your blood pressure with||
9116|058|S|medication.||
9116|059|S|   Tell your doctor right away if you have any serious side||
9116|060|S|effects, including: mental/mood changes (such as anxiety,||
9116|061|S|depression, increased anger), trouble sleeping/snoring, signs of||
9116|062|S|liver disease (such as nausea/vomiting that doesn't stop, loss of||
9116|063|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
9116|064|S|urine), hands/ankles/feet swelling, unusual tiredness,||
9116|065|S|fast/irregular heartbeat.||
9116|066|S|   Get medical help right away if you have any very serious side||
9116|067|S|effects, including: shortness of breath/rapid breathing,||
9116|068|S|chest/jaw/left arm pain, unusual sweating, confusion, sudden||
9116|069|S|dizziness/fainting, pain/swelling/warmth in the groin/calf,||
9116|070|S|sudden/severe headaches, trouble speaking, weakness on one side||
9116|071|S|of the body, sudden vision changes.||
9116|072|S|   If you are male, tell your doctor right away if you have any||
9116|073|S|serious side effects, including: trouble urinating, breast||
9116|074|S|swelling/tenderness, too frequent/prolonged erections.||
9116|075|S|   Rarely, males may have a painful or prolonged erection lasting||
9116|076|S|4 or more hours. If this occurs, stop using this drug and get||
9116|077|S|medical help right away, or permanent problems could occur.||
9116|078|S|   If you are female, tell your doctor right away if you have any||
9116|079|S|serious side effects, including: deepening of the voice,||
9116|080|S|hoarseness, unusual facial/body hair growth, enlarged clitoris,||
9116|081|S|irregular menstrual periods.||
9116|082|S|   A very serious allergic reaction to this drug is rare.||
9116|083|S|However, get medical help right away if you notice any symptoms||
9116|084|S|of a serious allergic reaction, including: rash, itching/swelling||
9116|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9116|086|S|breathing.||
9116|087|S|   This is not a complete list of possible side effects. If you||
9116|088|S|notice other effects not listed above, contact your doctor or||
9116|089|S|pharmacist.||
9116|090|S|   In the US -||
9116|091|S|   Call your doctor for medical advice about side effects. You||
9116|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9116|093|S|www.fda.gov/medwatch.||
9116|094|S|   In Canada - Call your doctor for medical advice about side||
9116|095|S|effects. You may report side effects to Health Canada at||
9116|096|S|1-866-234-2345.||
9116|097|B|||
9116|098|P|PRECAUTIONS:  Before using methyltestosterone, tell your doctor||
9116|099|P|or pharmacist if you are allergic to it; or if you have any other||
9116|100|P|allergies. This product may contain inactive ingredients, which||
9116|101|P|can cause allergic reactions or other problems. Talk to your||
9116|102|P|pharmacist for more details.||
9116|103|P|   Before using this medication, tell your doctor or pharmacist||
9116|104|P|your medical history, especially of: cancer (such as breast||
9116|105|P|cancer in men, prostate cancer), blood clots (such as in the leg,||
9116|106|P|lungs), heart disease (such as heart failure, chest pain, heart||
9116|107|P|attack), stroke, liver problems, kidney problems, certain mineral||
9116|108|P|imbalance (high calcium blood level), high cholesterol, high||
9116|109|P|blood pressure, enlarged prostate, breathing problems (such as||
9116|110|P|sleep apnea, chronic obstructive pulmonary disease-COPD),||
9116|111|P|diabetes.||
9116|112|P|   If you have diabetes, this product may lower your blood sugar.||
9116|113|P|Check your blood sugar regularly as directed and share the||
9116|114|P|results with your doctor. Tell your doctor right away if you have||
9116|115|P|symptoms of low blood sugar, such as sudden sweating, shaking,||
9116|116|P|fast heartbeat, hunger, blurred vision, dizziness, or tingling||
9116|117|P|hands/feet. Your doctor may need to adjust your diabetes||
9116|118|P|medication, exercise program, or diet.||
9116|119|P|   Before having surgery, tell your doctor or dentist about all||
9116|120|P|the products you use (including prescription drugs,||
9116|121|P|nonprescription drugs, and herbal products).||
9116|122|P|   Older adults may be more sensitive to the side effects of this||
9116|123|P|drug, especially prostate/liver problems, swelling of arms/legs.||
9116|124|P|   Children may be more sensitive to the side effects of this||
9116|125|P|drug. In children, it may affect bone growth. Monitor your||
9116|126|P|child's height periodically.||
9116|127|P|   This medication can affect fertility in males. Ask your doctor||
9116|128|P|for more details.||
9116|129|P|   This medication must not be used during pregnancy. It may harm||
9116|130|P|an unborn baby. Discuss the use of reliable forms of birth||
9116|131|P|control (such as condoms, birth control pills) with your doctor.||
9116|132|P|If you become pregnant or think you may be pregnant, tell your||
9116|133|P|doctor right away.||
9116|134|P|   It is unknown if this drug passes into breast milk. Because of||
9116|135|P|the possible risk to the infant, breastfeeding is not recommended||
9116|136|P|while using this drug. Consult your doctor before breastfeeding.||
9116|137|B|||
9116|138|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9116|139|I|medications work or increase your risk for serious side effects.||
9116|140|I|This document does not contain all possible drug interactions.||
9116|141|I|Keep a list of all the products you use (including||
9116|142|I|prescription/nonprescription drugs and herbal products) and share||
9116|143|I|it with your doctor and pharmacist. Do not start, stop, or change||
9116|144|I|the dosage of any medicines without your doctor's approval.||
9116|145|I|   Some products that may interact with this drug include: "blood||
9116|146|I|thinners" (such as warfarin).||
9116|147|I|   This medication may interfere with certain lab tests (such as||
9116|148|I|thyroid function tests), possibly causing false test results.||
9116|149|I|Make sure lab personnel and all your doctors know you use this||
9116|150|I|drug.||
9116|151|B|||
9116|152|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9116|153|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9116|154|O|poison control center right away. US residents can call||
9116|155|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9116|156|B|||
9116|157|N|NOTES:  Do not share this medication with others. Sharing it is||
9116|158|N|against the law.||
9116|159|N|   Lab and/or medical tests (such as blood testosterone levels,||
9116|160|N|red blood cell counts, liver function, blood cholesterol levels,||
9116|161|N|PSA test) should be done while you are taking this medication.||
9116|162|N|Keep all medical and lab appointments. Consult your doctor for||
9116|163|N|more details.||
9116|164|B|||
9116|165|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9116|166|D|remember. If it is near the time of the next dose, skip the||
9116|167|D|missed dose. Take your next dose at the regular time. Do not||
9116|168|D|double the dose to catch up.||
9116|169|B|||
9116|170|R|STORAGE:  Store at room temperature away from light and moisture.||
9116|171|R|Do not store in the bathroom. Keep all medications away from||
9116|172|R|children and pets.||
9116|173|R|   Do not flush medications down the toilet or pour them into a||
9116|174|R|drain unless instructed to do so. Properly discard this product||
9116|175|R|when it is expired or no longer needed. Consult your pharmacist||
9116|176|R|or local waste disposal company.||
9116|177|B|||
9116|178|A|Information last revised March 2025.||
9116|179|A|Copyright(c) 2025 First Databank, Inc.||
9116|180|B|||
9117|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9117|002|Z|does NOT have all possible information about this product. This||
9117|003|Z|information does not assure that this product is safe, effective,||
9117|004|Z|or appropriate for you. This information is not individual||
9117|005|Z|medical advice and does not substitute for the advice of your||
9117|006|Z|health care professional. Always ask your health care||
9117|007|Z|professional for complete information about this product and your||
9117|008|Z|specific health needs.||
9117|009|B|||
9117|010|T|LEUCOVORIN - ORAL||
9117|011|F|(lew-ko-VORE-in)||
9117|012|B|||
9117|013|U|USES:  This medication is used to treat or prevent serious blood||
9117|014|U|cell disorders (such as thrombocytopenia, neutropenia, anemia)||
9117|015|U|caused by certain drugs (folic acid antagonists such as||
9117|016|U|methotrexate, trimethoprim, pyrimethamine).||
9117|017|B|||
9117|018|H|HOW TO USE:  Take this medication by mouth with or without food||
9117|019|H|as directed by your doctor, usually every 6 hours or once daily.||
9117|020|H|   The dosage is based on your medical condition and response to||
9117|021|H|treatment.||
9117|022|H|   Use this medication regularly to get the most benefit from it.||
9117|023|H|To help you remember, take it at the same time(s) each day.||
9117|024|H|   Tell your doctor if you are unable to take this medication||
9117|025|H|because of nausea/vomiting. You may need to be switched to the||
9117|026|H|injection form of this medication.||
9117|027|B|||
9117|028|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
9117|029|S|because your doctor has judged that the benefit to you is greater||
9117|030|S|than the risk of side effects. Many people using this medication||
9117|031|S|do not have serious side effects.||
9117|032|S|   A very serious allergic reaction to this drug is rare.||
9117|033|S|However, get medical help right away if you notice any symptoms||
9117|034|S|of a serious allergic reaction, including: rash, itching/swelling||
9117|035|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9117|036|S|breathing.||
9117|037|S|   This is not a complete list of possible side effects. If you||
9117|038|S|notice other effects not listed above, contact your doctor or||
9117|039|S|pharmacist.||
9117|040|S|   In the US -||
9117|041|S|   Call your doctor for medical advice about side effects. You||
9117|042|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9117|043|S|www.fda.gov/medwatch.||
9117|044|S|   In Canada - Call your doctor for medical advice about side||
9117|045|S|effects. You may report side effects to Health Canada at||
9117|046|S|1-866-234-2345.||
9117|047|B|||
9117|048|P|PRECAUTIONS:  Before taking leucovorin, tell your doctor or||
9117|049|P|pharmacist if you are allergic to it; or to levoleucovorin; or to||
9117|050|P|folic acid or folinic acid; or if you have any other allergies.||
9117|051|P|This product may contain inactive ingredients, which can cause||
9117|052|P|allergic reactions or other problems. Talk to your pharmacist for||
9117|053|P|more details.||
9117|054|P|   Before using this medication, tell your doctor or pharmacist||
9117|055|P|your medical history, especially of: certain anemias (due to||
9117|056|P|vitamin B12 deficiency).||
9117|057|P|   Before having surgery, tell your doctor or dentist about all||
9117|058|P|the products you use (including prescription drugs,||
9117|059|P|nonprescription drugs, and herbal products).||
9117|060|P|   During pregnancy, this medication should be used only when||
9117|061|P|clearly needed. Discuss the risks and benefits with your doctor.||
9117|062|P|   It is unknown if this medication passes into breast milk.||
9117|063|P|Consult your doctor before breastfeeding.||
9117|064|B|||
9117|065|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9117|066|I|medications work or increase your risk for serious side effects.||
9117|067|I|This document does not contain all possible drug interactions.||
9117|068|I|Keep a list of all the products you use (including||
9117|069|I|prescription/nonprescription drugs and herbal products) and share||
9117|070|I|it with your doctor and pharmacist. Do not start, stop, or change||
9117|071|I|the dosage of any medicines without your doctor's approval.||
9117|072|I|   Leucovorin is very similar to levoleucovorin. Do not use||
9117|073|I|medications containing levoleucovorin while using leucovorin.||
9117|074|B|||
9117|075|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9117|076|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9117|077|O|poison control center right away. US residents can call||
9117|078|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9117|079|B|||
9117|080|N|NOTES:  Do not share this medication with others.||
9117|081|N|   Lab and/or medical tests (such as kidney function, complete||
9117|082|N|blood count, folic acid antagonist blood levels) should be done||
9117|083|N|while you are taking this medication. Keep all medical and lab||
9117|084|N|appointments. Consult your doctor for more details.||
9117|085|B|||
9117|086|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9117|087|D|remember. If it is near the time of the next dose, skip the||
9117|088|D|missed dose. Take your next dose at the regular time. Do not||
9117|089|D|double the dose to catch up.||
9117|090|B|||
9117|091|R|STORAGE:  Store at room temperature away from light and moisture.||
9117|092|R|Do not store in the bathroom. Keep all medications away from||
9117|093|R|children and pets.||
9117|094|R|   Do not flush medications down the toilet or pour them into a||
9117|095|R|drain unless instructed to do so. Properly discard this product||
9117|096|R|when it is expired or no longer needed. Consult your pharmacist||
9117|097|R|or local waste disposal company.||
9117|098|B|||
9117|099|A|Information last revised May 2024.||
9117|100|A|Copyright(c) 2025 First Databank, Inc.||
9117|101|B|||
9119|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9119|002|Z|does NOT have all possible information about this product. This||
9119|003|Z|information does not assure that this product is safe, effective,||
9119|004|Z|or appropriate for you. This information is not individual||
9119|005|Z|medical advice and does not substitute for the advice of your||
9119|006|Z|health care professional. Always ask your health care||
9119|007|Z|professional for complete information about this product and your||
9119|008|Z|specific health needs.||
9119|009|B|||
9119|010|T|PRAZIQUANTEL - ORAL||
9119|011|F|(prazz-ih-KWAN-tull)||
9119|012|B|||
9119|013|C|COMMON BRAND NAME(S): Biltricide||
9119|014|B|||
9119|015|U|USES:  This medication is used to treat infections of certain||
9119|016|U|parasites (such as Schistosoma and liver flukes). Curing||
9119|017|U|parasitic infections helps to improve your health and quality of||
9119|018|U|life. Praziquantel belongs to a class of drugs known as||
9119|019|U|anthelmintics. It works by killing the parasites. It also||
9119|020|U|paralyzes the parasites, causing them to release their hold on||
9119|021|U|the blood vessel walls so the body can remove them naturally.||
9119|022|B|||
9119|023|V|OTHER USES:  This section contains uses of this drug that are not||
9119|024|V|listed in the approved professional labeling for the drug but||
9119|025|V|that may be prescribed by your health care professional. Use this||
9119|026|V|drug for a condition that is listed in this section only if it||
9119|027|V|has been so prescribed by your health care professional.||
9119|028|V|   This drug may also be used for other parasite infections (such||
9119|029|V|as tapeworms, intestinal and lung flukes).||
9119|030|B|||
9119|031|H|HOW TO USE:  Take this medication by mouth with a meal as||
9119|032|H|directed by your doctor, usually 3 times a day (4 to 6 hours||
9119|033|H|apart) for 1 day. Quickly swallow the tablets or tablet segments||
9119|034|H|with a full glass of water (8 ounces or 240 milliliters). Do not||
9119|035|H|chew or suck the tablets because the bitter taste of praziquantel||
9119|036|H|may cause gagging or vomiting. Your doctor may direct you to take||
9119|037|H|this medication fewer than 3 times a day or to take it for longer||
9119|038|H|than 1 day. Follow your doctor's directions exactly.||
9119|039|H|   If you have trouble swallowing the tablets or tablet segments,||
9119|040|H|you may crush the medication and mix it in soft foods or liquids.||
9119|041|H|Take the mixture within 1 hour of mixing.||
9119|042|H|   The dosage is based on your medical condition, weight, and||
9119|043|H|response to treatment. Tablets are scored with lines. You may||
9119|044|H|need to break the tablet to get the correct dose. Ask your||
9119|045|H|pharmacist for directions on breaking the tablet to get the right||
9119|046|H|dose for you.||
9119|047|H|   Avoid eating grapefruit or drinking grapefruit juice while||
9119|048|H|using this medication unless your doctor or pharmacist says you||
9119|049|H|may do so safely. Grapefruit can increase the chance of side||
9119|050|H|effects with this medicine. Ask your doctor or pharmacist for||
9119|051|H|more details.||
9119|052|H|   Your symptoms may become worse when you start taking||
9119|053|H|praziquantel. Tell your doctor if your condition lasts or gets||
9119|054|H|worse.||
9119|055|B|||
9119|056|S|SIDE EFFECTS:  Headache, dizziness, stomach pain, nausea,||
9119|057|S|tiredness, weakness, joint/muscle pain, loss of appetite,||
9119|058|S|vomiting, and sweating may occur. These side effects are usually||
9119|059|S|mild and temporary and may be symptoms of your parasite infection||
9119|060|S|and/or the dying parasites. If any of these effects last or get||
9119|061|S|worse, tell your doctor or pharmacist promptly.||
9119|062|S|   Remember that this medication has been prescribed because your||
9119|063|S|doctor has judged that the benefit to you is greater than the||
9119|064|S|risk of side effects. Many people using this medication do not||
9119|065|S|have serious side effects.||
9119|066|S|   Tell your doctor right away if you have any serious side||
9119|067|S|effects, including: bloody diarrhea, fever, irregular/slow||
9119|068|S|heartbeat, seizures.||
9119|069|S|   A very serious allergic reaction to this drug is rare.||
9119|070|S|However, get medical help right away if you notice any symptoms||
9119|071|S|of a serious allergic reaction, including: rash, itching/swelling||
9119|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9119|073|S|breathing.||
9119|074|S|   This is not a complete list of possible side effects. If you||
9119|075|S|notice other effects not listed above, contact your doctor or||
9119|076|S|pharmacist.||
9119|077|S|   In the US -||
9119|078|S|   Call your doctor for medical advice about side effects. You||
9119|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9119|080|S|www.fda.gov/medwatch.||
9119|081|S|   In Canada - Call your doctor for medical advice about side||
9119|082|S|effects. You may report side effects to Health Canada at||
9119|083|S|1-866-234-2345.||
9119|084|B|||
9119|085|P|PRECAUTIONS:  Before taking praziquantel, tell your doctor or||
9119|086|P|pharmacist if you are allergic to it; or if you have any other||
9119|087|P|allergies. This product may contain inactive ingredients, which||
9119|088|P|can cause allergic reactions or other problems. Talk to your||
9119|089|P|pharmacist for more details.||
9119|090|P|   Before using this medication, tell your doctor or pharmacist||
9119|091|P|your medical history, especially of: liver disease, heart disease||
9119|092|P|(irregular heart rhythm), parasitic eye infection (ocular||
9119|093|P|cysticercosis), parasitic brain infection (cerebral||
9119|094|P|cysticercosis), seizures.||
9119|095|P|   This drug may make you dizzy during treatment until the day||
9119|096|P|after treatment. Alcohol or marijuana (cannabis) can make you||
9119|097|P|more dizzy. Do not drive, use machinery, or do anything that||
9119|098|P|needs alertness until you can do it safely. Limit alcoholic||
9119|099|P|beverages. Talk to your doctor if you are using marijuana||
9119|100|P|(cannabis).||
9119|101|P|   Before having surgery, tell your doctor or dentist about all||
9119|102|P|the products you use (such as prescription drugs, nonprescription||
9119|103|P|drugs, and herbal products).||
9119|104|P|   During pregnancy, this medication should be used only when||
9119|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
9119|106|P|   This drug passes into breast milk. Consult your doctor before||
9119|107|P|breastfeeding.||
9119|108|B|||
9119|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9119|110|I|medications work or increase your risk for serious side effects.||
9119|111|I|This document does not contain all possible drug interactions.||
9119|112|I|Keep a list of all the products you use (including||
9119|113|I|prescription/nonprescription drugs and herbal products) and share||
9119|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
9119|115|I|the dosage of any medicines without your doctor's approval.||
9119|116|I|   Other medications can affect the removal of praziquantel from||
9119|117|I|your body, which may affect how praziquantel works. Examples||
9119|118|I|include azole antifungals (such as itraconazole, ketoconazole),||
9119|119|I|chloroquine, cimetidine, dexamethasone, efavirenz, macrolide||
9119|120|I|antibiotics (such as erythromycin), rifamycins (such as||
9119|121|I|rifampin), St. John's wort, some drugs used to treat seizures||
9119|122|I|(such as carbamazepine, phenytoin, phenobarbital, primidone),||
9119|123|I|among others.||
9119|124|B|||
9119|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9119|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9119|127|O|poison control center right away. US residents can call||
9119|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9119|129|B|||
9119|130|N|NOTES:  Do not share this medication with others.||
9119|131|N|   Lab and/or medical tests (such as examination of urine/stool,||
9119|132|N|biopsy of infected tissue) should be done while you are taking||
9119|133|N|this medication. If you have a heart condition, you may need||
9119|134|N|additional monitoring. Keep all medical and lab appointments.||
9119|135|N|Consult your doctor for more details.||
9119|136|B|||
9119|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9119|138|D|remember. If it is near the time of the next dose, skip the||
9119|139|D|missed dose. Take your next dose at the regular time. Do not||
9119|140|D|double the dose to catch up.||
9119|141|B|||
9119|142|R|STORAGE:  Store at room temperature away from light and moisture.||
9119|143|R|Do not store in the bathroom. Keep all medications away from||
9119|144|R|children and pets.||
9119|145|R|   Do not flush medications down the toilet or pour them into a||
9119|146|R|drain unless instructed to do so. Properly discard this product||
9119|147|R|when it is expired or no longer needed. Consult your pharmacist||
9119|148|R|or local waste disposal company.||
9119|149|B|||
9119|150|A|Information last revised November 2024.||
9119|151|A|Copyright(c) 2025 First Databank, Inc.||
9119|152|B|||
9120|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9120|002|Z|does NOT have all possible information about this product. This||
9120|003|Z|information does not assure that this product is safe, effective,||
9120|004|Z|or appropriate for you. This information is not individual||
9120|005|Z|medical advice and does not substitute for the advice of your||
9120|006|Z|health care professional. Always ask your health care||
9120|007|Z|professional for complete information about this product and your||
9120|008|Z|specific health needs.||
9120|009|B|||
9120|010|T|NORETHINDRONE - ORAL||
9120|011|F|(nor-ETH-in-drone)||
9120|012|B|||
9120|013|C|COMMON BRAND NAME(S): Aygestin||
9120|014|B|||
9120|015|U|USES:  This medication is used to treat women with abnormal||
9120|016|U|bleeding from the uterus. It is also used to treat women who have||
9120|017|U|stopped having menstrual periods for several months (amenorrhea)||
9120|018|U|but who are not pregnant or going through menopause. In addition,||
9120|019|U|this medication is used to treat a condition (endometriosis) in||
9120|020|U|which tissue that normally lines the inside of the uterus is||
9120|021|U|found outside the uterus in the abdomen/pelvic area, causing||
9120|022|U|painful/irregular periods. Norethindrone is a type of hormone||
9120|023|U|(progestin). It is like the hormone progesterone that your body||
9120|024|U|makes naturally. This medication works by stopping the normal||
9120|025|U|growth of the uterus lining during the menstrual cycle and||
9120|026|U|signaling hormone changes in the uterus to restore normal||
9120|027|U|menstrual periods.||
9120|028|U|   This medication must not be used to test for pregnancy.||
9120|029|U|   Progestins are not effective in preventing miscarriages.||
9120|030|B|||
9120|031|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9120|032|H|from your pharmacist before you start using this drug and each||
9120|033|H|time you get a refill. If you have any questions, ask your doctor||
9120|034|H|or pharmacist.||
9120|035|H|   Take this medication by mouth as prescribed by your doctor.||
9120|036|H|You may take it with food or after a meal to prevent stomach||
9120|037|H|upset. Follow the dosing schedule carefully. Ask your doctor if||
9120|038|H|you have any questions. The dosage is based on your medical||
9120|039|H|condition and response to treatment.||
9120|040|H|   For the treatment of stopped menstrual periods and abnormal||
9120|041|H|bleeding from the uterus, take this drug as directed by your||
9120|042|H|doctor, usually once daily for 5 to 10 days during the second||
9120|043|H|half of the planned menstrual cycle. Withdrawal bleeding usually||
9120|044|H|occurs within 3 to 7 days after you stop taking the medication.||
9120|045|H|   Tell your doctor if your condition lasts or gets worse.||
9120|046|B|||
9120|047|S|SIDE EFFECTS:  Nausea, vomiting, headache, dizziness, mood||
9120|048|S|swings, trouble sleeping, weight gain/loss, acne, breast||
9120|049|S|swelling/tenderness, change in sexual interest, unwanted hair||
9120|050|S|growth, or hair loss may occur. If any of these effects last or||
9120|051|S|get worse, tell your doctor or pharmacist promptly.||
9120|052|S|   Remember that this medication has been prescribed because your||
9120|053|S|doctor has judged that the benefit to you is greater than the||
9120|054|S|risk of side effects. Many people using this medication do not||
9120|055|S|have serious side effects.||
9120|056|S|   Tell your doctor right away if you have any serious side||
9120|057|S|effects, including: changes in vaginal bleeding (such as||
9120|058|S|spotting, breakthrough bleeding, changes in menstrual flow, no||
9120|059|S|menstrual bleeding), change in vaginal discharge, depression,||
9120|060|S|swelling of the hands/feet, frequent/burning/painful urination,||
9120|061|S|yellowing eyes/skin, dark patches on the skin or face (melasma).||
9120|062|S|   This medication, especially if used along with an estrogen||
9120|063|S|product, may rarely cause very serious (possibly fatal) problems||
9120|064|S|from blood clots (such as heart attack, stroke, blood clots in||
9120|065|S|the lungs, legs, or eyes). Get medical help right away if you||
9120|066|S|have: chest/jaw/left arm pain, weakness on one side of the body,||
9120|067|S|trouble speaking, sudden vision changes, confusion, sudden/severe||
9120|068|S|headaches, sudden dizziness/fainting, shortness of breath/rapid||
9120|069|S|breathing, pain/swelling/warmth in the groin/calf, unusual||
9120|070|S|sweating.||
9120|071|S|   A very serious allergic reaction to this drug is rare.||
9120|072|S|However, get medical help right away if you notice any symptoms||
9120|073|S|of a serious allergic reaction, including: rash, itching/swelling||
9120|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9120|075|S|breathing.||
9120|076|S|   This is not a complete list of possible side effects. If you||
9120|077|S|notice other effects not listed above, contact your doctor or||
9120|078|S|pharmacist.||
9120|079|S|   In the US -||
9120|080|S|   Call your doctor for medical advice about side effects. You||
9120|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9120|082|S|www.fda.gov/medwatch.||
9120|083|S|   In Canada - Call your doctor for medical advice about side||
9120|084|S|effects. You may report side effects to Health Canada at||
9120|085|S|1-866-234-2345.||
9120|086|B|||
9120|087|P|PRECAUTIONS:  Before taking norethindrone, tell your doctor or||
9120|088|P|pharmacist if you are allergic to it; or if you have any other||
9120|089|P|allergies. This product may contain inactive ingredients, which||
9120|090|P|can cause allergic reactions or other problems. Talk to your||
9120|091|P|pharmacist for more details.||
9120|092|P|   Before using this medication, tell your doctor or pharmacist||
9120|093|P|your medical history, especially of: vaginal bleeding of unknown||
9120|094|P|cause, bleeding in the brain, a loss of pregnancy with some||
9120|095|P|tissue remaining in the uterus ("missed abortion"), family||
9120|096|P|medical history (especially breast lumps/cancer or blood clots),||
9120|097|P|obesity, heart disease (such as heart attacks, coronary artery||
9120|098|P|disease, heart failure), high blood pressure, cancer (especially||
9120|099|P|endometrial or breast cancer), blood clots, lupus, seizures,||
9120|100|P|migraine headaches, asthma, liver disease, kidney problems, high||
9120|101|P|blood levels of cholesterol/fats, depression, diabetes, strokes,||
9120|102|P|smoking.||
9120|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9120|104|P|can make you more dizzy. Do not drive, use machinery, or do||
9120|105|P|anything that needs alertness until you can do it safely. Limit||
9120|106|P|alcoholic beverages. Talk to your doctor if you are using||
9120|107|P|marijuana (cannabis).||
9120|108|P|   Before having surgery, tell your doctor or dentist about all||
9120|109|P|the products you use (including prescription drugs,||
9120|110|P|nonprescription drugs, and herbal products).||
9120|111|P|   This medication may cause blotchy, dark areas on your face and||
9120|112|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
9120|113|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
9120|114|P|wear protective clothing when outdoors.||
9120|115|P|   This medication should not be used during pregnancy. If you||
9120|116|P|become pregnant or think you may be pregnant, tell your doctor||
9120|117|P|right away.||
9120|118|P|   This drug passes into breast milk. Consult your doctor before||
9120|119|P|breastfeeding.||
9120|120|B|||
9120|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9120|122|I|medications work or increase your risk for serious side effects.||
9120|123|I|This document does not contain all possible drug interactions.||
9120|124|I|Keep a list of all the products you use (including||
9120|125|I|prescription/nonprescription drugs and herbal products) and share||
9120|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
9120|127|I|the dosage of any medicines without your doctor's approval.||
9120|128|I|   Other medications can affect the removal of norethindrone from||
9120|129|I|your body, which may affect how norethindrone works. Examples||
9120|130|I|include azole antifungals (such as itraconazole), rifamycins||
9120|131|I|(such as rifampin, rifabutin), St. John's wort, drugs used to||
9120|132|I|treat seizures (such as carbamazepine, phenytoin), among others.||
9120|133|I|   This medication may interfere with certain lab tests, possibly||
9120|134|I|causing false test results. Make sure lab personnel and all your||
9120|135|I|doctors know you use this drug.||
9120|136|B|||
9120|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9120|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9120|139|O|poison control center right away. US residents can call||
9120|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9120|141|O|Symptoms of overdose may include severe nausea and vomiting.||
9120|142|B|||
9120|143|N|NOTES:  Do not share this medication with others.||
9120|144|N|   Regular complete physical exams which include lab and/or||
9120|145|N|medical tests (such as blood pressure, breast exam, pelvic exam,||
9120|146|N|Pap smear) should be done while you are taking this medication.||
9120|147|N|Follow your doctor's instructions for examining your breasts, and||
9120|148|N|report any lumps right away. Keep all medical and lab||
9120|149|N|appointments. Consult your doctor for more details.||
9120|150|B|||
9120|151|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9120|152|D|remember. If it is near the time of the next dose, skip the||
9120|153|D|missed dose. Take your next dose at the regular time. Do not||
9120|154|D|double the dose to catch up.||
9120|155|B|||
9120|156|R|STORAGE:  Store at room temperature away from light and moisture.||
9120|157|R|Do not store in the bathroom. Keep all medications away from||
9120|158|R|children and pets.||
9120|159|R|   Do not flush medications down the toilet or pour them into a||
9120|160|R|drain unless instructed to do so. Properly discard this product||
9120|161|R|when it is expired or no longer needed. Consult your pharmacist||
9120|162|R|or local waste disposal company.||
9120|163|B|||
9120|164|A|Information last revised July 2024.||
9120|165|A|Copyright(c) 2025 First Databank, Inc.||
9120|166|B|||
9121|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9121|002|Z|does NOT have all possible information about this product. This||
9121|003|Z|information does not assure that this product is safe, effective,||
9121|004|Z|or appropriate for you. This information is not individual||
9121|005|Z|medical advice and does not substitute for the advice of your||
9121|006|Z|health care professional. Always ask your health care||
9121|007|Z|professional for complete information about this product and your||
9121|008|Z|specific health needs.||
9121|009|B|||
9121|010|T|FOSFOMYCIN - ORAL||
9121|011|F|(FOS-foe-MYE-sin troe-METH-a-meen)||
9121|012|B|||
9121|013|C|COMMON BRAND NAME(S): Monurol||
9121|014|B|||
9121|015|U|USES:  This medication is an antibiotic used to treat bladder||
9121|016|U|infections (such as acute cystitis or lower urinary tract||
9121|017|U|infections) in women. It works by stopping the growth of||
9121|018|U|bacteria. This antibiotic treats only bacterial infections. It||
9121|019|U|will not work for viral infections (such as common cold, flu).||
9121|020|U|Using any antibiotic when it is not needed can cause it to not||
9121|021|U|work for future infections.||
9121|022|U|   Fosfomycin should not be used to treat infections outside the||
9121|023|U|bladder (such as kidney infections).||
9121|024|B|||
9121|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9121|026|H|from your pharmacist before you start taking fosfomycin. If you||
9121|027|H|have any questions, ask your doctor or pharmacist.||
9121|028|H|   Take this medication by mouth as directed by your doctor,||
9121|029|H|usually 1 packet (sachet) as a single dose. Mix this drug with||
9121|030|H|water before taking it. Pour the contents of 1 packet (sachet)||
9121|031|H|into a half glass (4 ounces or 120 milliliters) of cold water and||
9121|032|H|stir to dissolve. Do not use warm or hot water. Drink all of the||
9121|033|H|mixture right away.||
9121|034|H|   Your symptoms should get better within 2 to 3 days. Tell your||
9121|035|H|doctor if you do not get better after 3 days or if you get worse.||
9121|036|B|||
9121|037|S|SIDE EFFECTS:  Diarrhea, nausea, headache, vaginal discomfort, or||
9121|038|S|dizziness may occur. If any of these effects last or get worse,||
9121|039|S|tell your doctor or pharmacist promptly.||
9121|040|S|   Remember that this medication has been prescribed because your||
9121|041|S|doctor has judged that the benefit to you is greater than the||
9121|042|S|risk of side effects. Many people using this medication do not||
9121|043|S|have serious side effects.||
9121|044|S|   Tell your doctor right away if you have any serious side||
9121|045|S|effects, including: vision changes, unusual weakness.||
9121|046|S|   This medication may rarely cause a severe intestinal condition||
9121|047|S|due to a bacteria called C. difficile. This condition may occur||
9121|048|S|during treatment or weeks to months after treatment has stopped.||
9121|049|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9121|050|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9121|051|S|stool.||
9121|052|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9121|053|S|products because they may make symptoms worse.||
9121|054|S|   A very serious allergic reaction to this drug is rare.||
9121|055|S|However, get medical help right away if you notice any symptoms||
9121|056|S|of a serious allergic reaction, including: rash, itching/swelling||
9121|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9121|058|S|breathing.||
9121|059|S|   This is not a complete list of possible side effects. If you||
9121|060|S|notice other effects not listed above, contact your doctor or||
9121|061|S|pharmacist.||
9121|062|S|   In the US -||
9121|063|S|   Call your doctor for medical advice about side effects. You||
9121|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9121|065|S|www.fda.gov/medwatch.||
9121|066|S|   In Canada - Call your doctor for medical advice about side||
9121|067|S|effects. You may report side effects to Health Canada at||
9121|068|S|1-866-234-2345.||
9121|069|B|||
9121|070|P|PRECAUTIONS:  Before taking fosfomycin, tell your doctor or||
9121|071|P|pharmacist if you are allergic to it; or if you have any other||
9121|072|P|allergies. This product may contain inactive ingredients, which||
9121|073|P|can cause allergic reactions or other problems. Talk to your||
9121|074|P|pharmacist for more details.||
9121|075|P|   Before using this medication, tell your doctor or pharmacist||
9121|076|P|your medical history, especially of: kidney disease.||
9121|077|P|   If you develop symptoms of a kidney infection (such as pain in||
9121|078|P|your side or lower back area, fever, chills), contact your doctor||
9121|079|P|right away. Your doctor may change your treatment.||
9121|080|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9121|081|P|can make you more dizzy. Do not drive, use machinery, or do||
9121|082|P|anything that needs alertness until you can do it safely. Limit||
9121|083|P|alcoholic beverages. Talk to your doctor if you are using||
9121|084|P|marijuana (cannabis).||
9121|085|P|   This product may contain sugar and/or aspartame. Caution is||
9121|086|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
9121|087|P|condition that requires you to limit/avoid these substances in||
9121|088|P|your diet. Ask your doctor or pharmacist about using this product||
9121|089|P|safely.||
9121|090|P|   Fosfomycin may cause live bacterial vaccines (such as typhoid||
9121|091|P|vaccine) to not work well. Tell your health care professional||
9121|092|P|that you are using fosfomycin before having any||
9121|093|P|immunizations/vaccinations.||
9121|094|P|   Before having surgery, tell your doctor or dentist about all||
9121|095|P|the products you use (including prescription drugs,||
9121|096|P|nonprescription drugs, and herbal products).||
9121|097|P|   During pregnancy, this medication should be used only when||
9121|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
9121|099|P|   This drug passes into breast milk in small amounts, but is||
9121|100|P|unlikely to harm a nursing infant. Consult your doctor before||
9121|101|P|breastfeeding.||
9121|102|B|||
9121|103|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9121|104|I|medications work or increase your risk for serious side effects.||
9121|105|I|This document does not contain all possible drug interactions.||
9121|106|I|Keep a list of all the products you use (including||
9121|107|I|prescription/nonprescription drugs and herbal products) and share||
9121|108|I|it with your doctor and pharmacist. Do not start, stop, or change||
9121|109|I|the dosage of any medicines without your doctor's approval.||
9121|110|I|   A product that may interact with this drug is: metoclopramide.||
9121|111|B|||
9121|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9121|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9121|114|O|poison control center right away. US residents can call||
9121|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9121|116|O|Symptoms of overdose may include: hearing loss, metallic taste.||
9121|117|B|||
9121|118|N|NOTES:  Do not share this medication with others.||
9121|119|N|   This medication has been prescribed for your current condition||
9121|120|N|only. Do not use it later for another infection unless your||
9121|121|N|doctor tells you to.||
9121|122|N|   Lab and/or medical tests (such as urine culture) may be done||
9121|123|N|while you are taking this medication. Keep all medical and lab||
9121|124|N|appointments.||
9121|125|B|||
9121|126|D|MISSED DOSE:  Not applicable.||
9121|127|B|||
9121|128|R|STORAGE:  Store at room temperature away from light and moisture.||
9121|129|R|Do not store in the bathroom. Keep all medications away from||
9121|130|R|children and pets.||
9121|131|R|   Do not flush medications down the toilet or pour them into a||
9121|132|R|drain unless instructed to do so. Properly discard this product||
9121|133|R|when it is expired or no longer needed. Consult your pharmacist||
9121|134|R|or local waste disposal company.||
9121|135|B|||
9121|136|A|Information last revised August 2025.||
9121|137|A|Copyright(c) 2025 First Databank, Inc.||
9121|138|B|||
9122|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9122|002|Z|does NOT have all possible information about this product. This||
9122|003|Z|information does not assure that this product is safe, effective,||
9122|004|Z|or appropriate for you. This information is not individual||
9122|005|Z|medical advice and does not substitute for the advice of your||
9122|006|Z|health care professional. Always ask your health care||
9122|007|Z|professional for complete information about this product and your||
9122|008|Z|specific health needs.||
9122|009|B|||
9122|010|T|IODINE, STRONG - ORAL||
9122|011|F|(EYE-oh-dine)||
9122|012|B|||
9122|013|U|USES:  This medication contains iodine and potassium iodide. It||
9122|014|U|is used along with antithyroid medicines to prepare the thyroid||
9122|015|U|gland for surgical removal and to treat certain overactive||
9122|016|U|thyroid conditions (hyperthyroidism, thyroid storm). It works by||
9122|017|U|shrinking the size of the thyroid gland and by decreasing the||
9122|018|U|amount of thyroid hormones the body makes.||
9122|019|U|   This medication may also be used to protect the thyroid gland||
9122|020|U|after radioactive iodine treatment or in a radiation exposure||
9122|021|U|emergency. In such cases, this product blocks the thyroid gland||
9122|022|U|from absorbing radioactive iodine, protecting it from damage and||
9122|023|U|reducing the risk of thyroid cancer. In a radiation exposure||
9122|024|U|emergency, use this medication along with other emergency||
9122|025|U|measures that will be recommended to you by public health and||
9122|026|U|safety officials (such as finding safe shelter, evacuation,||
9122|027|U|controlling food supply).||
9122|028|U|   This medication may also be used for other conditions as||
9122|029|U|determined by your doctor (such as treatment of iodine||
9122|030|U|deficiency).||
9122|031|B|||
9122|032|H|HOW TO USE:  Take this medication by mouth as directed. Use the||
9122|033|H|dropper that comes with the bottle to measure the correct dose.||
9122|034|H|To improve the taste, mix the dose in a full glass (8 ounces or||
9122|035|H|240 milliliters) of water, milk, formula, or juice before taking.||
9122|036|H|To decrease stomach upset, take this medication after meals or||
9122|037|H|with food.||
9122|038|H|   Dosage is based on your medical condition and response to||
9122|039|H|treatment. Do not increase your dose, take it more often, or take||
9122|040|H|it for longer than prescribed or recommended because of the||
9122|041|H|increased risk of side effects.||
9122|042|H|   In a radiation emergency, take this drug only when public||
9122|043|H|health and safety officials tell you to do so. Start treatment as||
9122|044|H|soon as possible for the best protection. The length of treatment||
9122|045|H|will be determined by public health and safety officials.||
9122|046|H|   If so directed, use this medication regularly to get the most||
9122|047|H|benefit from it. To help you remember, take it at the same||
9122|048|H|time(s) each day.||
9122|049|H|   Tell your doctor if your condition lasts or gets worse.||
9122|050|B|||
9122|051|S|SIDE EFFECTS:  Nausea, vomiting, stomach ache, diarrhea, metallic||
9122|052|S|taste in the mouth, fever, headache, runny nose, sneezing, or||
9122|053|S|acne may occur. If any of these effects last or get worse, tell||
9122|054|S|your doctor or pharmacist promptly.||
9122|055|S|   Remember that this medication has been prescribed because your||
9122|056|S|doctor has judged that the benefit to you is greater than the||
9122|057|S|risk of side effects. Many people using this medication do not||
9122|058|S|have serious side effects.||
9122|059|S|   Tell your doctor right away if you have any serious side||
9122|060|S|effects, including: burning mouth/throat, sore teeth/gums,||
9122|061|S|swelling inside the mouth, increased saliva, eye||
9122|062|S|irritation/swollen eyelids, severe headache, swelling of the||
9122|063|S|front of the neck/throat (goiter), signs of decreased thyroid||
9122|064|S|gland function (such as weight gain, cold intolerance,||
9122|065|S|slow/irregular heartbeat, constipation, unusual tiredness),||
9122|066|S|confusion, numbness/tingling/pain/weakness of the hands/feet.||
9122|067|S|   Get medical help right away if you have any very serious side||
9122|068|S|effects, including: chest pain, black stools, vomit that looks||
9122|069|S|like coffee grounds, bloody diarrhea.||
9122|070|S|   A very serious allergic reaction to this drug is rare.||
9122|071|S|However, get medical help right away if you notice any symptoms||
9122|072|S|of a serious allergic reaction, including: rash, itching/swelling||
9122|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9122|074|S|breathing, fever with joint pain.||
9122|075|S|   This is not a complete list of possible side effects. If you||
9122|076|S|notice other effects not listed above, contact your doctor or||
9122|077|S|pharmacist.||
9122|078|S|   In the US -||
9122|079|S|   Call your doctor for medical advice about side effects. You||
9122|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9122|081|S|www.fda.gov/medwatch.||
9122|082|S|   In Canada - Call your doctor for medical advice about side||
9122|083|S|effects. You may report side effects to Health Canada at||
9122|084|S|1-866-234-2345.||
9122|085|B|||
9122|086|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9122|087|P|pharmacist if you are allergic to iodine or potassium iodide; or||
9122|088|P|if you have any other allergies. This product may contain||
9122|089|P|inactive ingredients, which can cause allergic reactions or other||
9122|090|P|problems. Talk to your pharmacist for more details.||
9122|091|P|   Before using this medication, tell your doctor or pharmacist||
9122|092|P|your medical history, especially of: bronchitis, a certain type||
9122|093|P|of skin condition (dermatitis herpetiformis), a certain type of||
9122|094|P|blood vessel disease (hypocomplementemic vasculitis), any thyroid||
9122|095|P|problems (if you are taking this medication for non-thyroid||
9122|096|P|conditions), heart disease, tuberculosis, high level of potassium||
9122|097|P|in the blood, kidney disease, Addison's disease, a certain muscle||
9122|098|P|disorder (myotonia congenita).||
9122|099|P|   Caution is advised when this drug is given to newborn babies||
9122|100|P|younger than 1 month old. Repeated dosing increases the risk of||
9122|101|P|blocking thyroid function, possibly affecting the newborn's brain||
9122|102|P|development. Discuss the risks and benefits with the doctor.||
9122|103|P|Treated babies should be given thyroid function tests.||
9122|104|P|   During pregnancy, this medication should be used only when||
9122|105|P|clearly needed. Repeated dosing increases the risk of blocking||
9122|106|P|thyroid function in the unborn baby, possibly causing harm.||
9122|107|P|Discuss the risks and benefits with your doctor.||
9122|108|P|   This drug passes into breast milk and may have undesirable||
9122|109|P|effects on a nursing infant. Consult your doctor before||
9122|110|P|breastfeeding.||
9122|111|B|||
9122|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9122|113|I|medications work or increase your risk for serious side effects.||
9122|114|I|This document does not contain all possible drug interactions.||
9122|115|I|Keep a list of all the products you use (including||
9122|116|I|prescription/nonprescription drugs and herbal products) and share||
9122|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
9122|118|I|the dosage of any medicines without your doctor's approval.||
9122|119|I|   Some products that may interact with this drug are: ACE||
9122|120|I|inhibitors (such as captopril, lisinopril), angiotensin receptor||
9122|121|I|blockers (ARBs such as losartan, valsartan), certain "water||
9122|122|I|pills" (potassium-sparing diuretics such as amiloride,||
9122|123|I|spironolactone, triamterene), drospirenone, eplerenone, lithium,||
9122|124|I|drugs that contain potassium (including supplements such as||
9122|125|I|potassium chloride).||
9122|126|B|||
9122|127|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9122|128|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9122|129|O|poison control center right away. US residents can call||
9122|130|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9122|131|O|Symptoms of overdose may include: stomach pain, nausea/vomiting,||
9122|132|O|severe diarrhea, trouble breathing, weakness.||
9122|133|B|||
9122|134|N|NOTES:  Do not share this medication with others.||
9122|135|N|   Lab and/or medical tests (such as thyroid function) should be||
9122|136|N|done while you are taking this medication. Keep all medical and||
9122|137|N|lab appointments. Consult your doctor for more details.||
9122|138|B|||
9122|139|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9122|140|D|remember. If it is near the time of the next dose, skip the||
9122|141|D|missed dose. Take your next dose at the regular time. Do not||
9122|142|D|double the dose to catch up.||
9122|143|B|||
9122|144|R|STORAGE:  Store at room temperature away from light. Do not||
9122|145|R|freeze. Keep all medications away from children and pets.||
9122|146|R|   Do not flush medications down the toilet or pour them into a||
9122|147|R|drain unless instructed to do so. Properly discard this product||
9122|148|R|when it is expired or no longer needed. Consult your pharmacist||
9122|149|R|or local waste disposal company.||
9122|150|B|||
9122|151|A|Information last revised September 2024.||
9122|152|A|Copyright(c) 2025 First Databank, Inc.||
9122|153|B|||
9123|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9123|002|Z|does NOT have all possible information about this product. This||
9123|003|Z|information does not assure that this product is safe, effective,||
9123|004|Z|or appropriate for you. This information is not individual||
9123|005|Z|medical advice and does not substitute for the advice of your||
9123|006|Z|health care professional. Always ask your health care||
9123|007|Z|professional for complete information about this product and your||
9123|008|Z|specific health needs.||
9123|009|B|||
9123|010|T|ALUMINUM HYDROXIDE SUSPENSION - ORAL||
9123|011|F|(a-LOO-mi-num hye-DROX-ide)||
9123|012|B|||
9123|013|C|COMMON BRAND NAME(S): Alternagel, Amphojel||
9123|014|B|||
9123|015|U|USES:  This medication is used to treat the symptoms of too much||
9123|016|U|stomach acid such as stomach upset, heartburn, and acid||
9123|017|U|indigestion. Aluminum hydroxide is an antacid that works quickly||
9123|018|U|to lower the acid in the stomach. Liquid antacids usually work||
9123|019|U|faster/better than tablets or capsules.||
9123|020|U|   This medication works only on existing acid in the stomach. It||
9123|021|U|does not prevent acid production. It may be used alone or with||
9123|022|U|other medications that lower acid production (including H2||
9123|023|U|blockers such as cimetidine/ranitidine and proton pump inhibitors||
9123|024|U|such as omeprazole).||
9123|025|B|||
9123|026|V|OTHER USES:  This section contains uses of this drug that are not||
9123|027|V|listed in the approved labeling for the drug but that may be||
9123|028|V|prescribed by your health care professional. Use this drug for a||
9123|029|V|condition that is listed in this section only if it has been so||
9123|030|V|prescribed by your health care professional.||
9123|031|V|   Aluminum hydroxide is also used to lower phosphate levels in||
9123|032|V|certain kidney conditions (usually in capsule form).||
9123|033|B|||
9123|034|H|HOW TO USE:  Take this medication by mouth between meals and at||
9123|035|H|bedtime. Follow all the directions on the product package or use||
9123|036|H|as directed by your doctor. If you have any questions, ask your||
9123|037|H|doctor or pharmacist.||
9123|038|H|   Shake the bottle well before each dose. Refrigerating the||
9123|039|H|suspension may improve the flavor. Do not freeze. This medication||
9123|040|H|works best if taken without other fluids. You can mix your dose||
9123|041|H|with a little water if needed.||
9123|042|H|   If your acid problems last or get worse after you have used||
9123|043|H|this product for 1 week, or if you think you have a serious||
9123|044|H|medical problem, get medical help right away. If you are using||
9123|045|H|this medication regularly on a daily basis for more than 2 weeks,||
9123|046|H|you may have a medical problem that needs different treatment.||
9123|047|H|Ask your doctor if this is the right medication for you.||
9123|048|B|||
9123|049|S|SIDE EFFECTS:  Constipation may occur. This could lead to other||
9123|050|S|problems such as hemorrhoids and bowel obstruction. If||
9123|051|S|constipation lasts or gets worse, tell your doctor or pharmacist||
9123|052|S|promptly.||
9123|053|S|   To minimize constipation, drink plenty of fluids and exercise.||
9123|054|S|Using an antacid that contains magnesium along with this product||
9123|055|S|can help prevent constipation. Stool softeners may also be||
9123|056|S|helpful. Ask your doctor or pharmacist about other antacids,||
9123|057|S|stool softeners and laxatives.||
9123|058|S|   If your doctor has directed you to use this medication,||
9123|059|S|remember that your doctor has judged that the benefit to you is||
9123|060|S|greater than the risk of side effects. Many people using this||
9123|061|S|medication do not have serious side effects.||
9123|062|S|   Aluminum-containing antacids bind to phosphate, an important||
9123|063|S|body chemical, in the gut. This can cause low phosphate levels if||
9123|064|S|your kidneys are normal, especially if you use large doses for a||
9123|065|S|long time. Tell your doctor right away if you have any of the||
9123|066|S|following symptoms of low phosphate: loss of appetite, unusual||
9123|067|S|tiredness, muscle weakness.||
9123|068|S|   Get medical help right away if you have any very serious side||
9123|069|S|effects, including: mental/mood changes (such as confusion, deep||
9123|070|S|sleep), pain with urination.||
9123|071|S|   A very serious allergic reaction to this drug is rare.||
9123|072|S|However, get medical help right away if you notice any symptoms||
9123|073|S|of a serious allergic reaction, including: rash, itching/swelling||
9123|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9123|075|S|breathing.||
9123|076|S|   This is not a complete list of possible side effects. If you||
9123|077|S|notice other effects not listed above, contact your doctor or||
9123|078|S|pharmacist.||
9123|079|S|   In the US -||
9123|080|S|   Call your doctor for medical advice about side effects. You||
9123|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9123|082|S|www.fda.gov/medwatch.||
9123|083|S|   In Canada - Call your doctor for medical advice about side||
9123|084|S|effects. You may report side effects to Health Canada at||
9123|085|S|1-866-234-2345.||
9123|086|B|||
9123|087|P|PRECAUTIONS:  Before taking aluminum hydroxide, tell your doctor||
9123|088|P|or pharmacist if you are allergic to it; or if you have any other||
9123|089|P|allergies. This product may contain inactive ingredients, which||
9123|090|P|can cause allergic reactions or other problems. Talk to your||
9123|091|P|pharmacist for more details.||
9123|092|P|   If you have any of the following health problems, consult your||
9123|093|P|doctor or pharmacist before using this product: frequent alcohol||
9123|094|P|use, dehydration/fluid restriction, problems with constipation,||
9123|095|P|kidney problems (including kidney stones).||
9123|096|P|   Before having surgery, tell your doctor or dentist about all||
9123|097|P|the products you use (including prescription drugs,||
9123|098|P|nonprescription drugs, and herbal products).||
9123|099|P|   During pregnancy, this medication should be used only when||
9123|100|P|clearly needed. Discuss the risks and benefits with your doctor.||
9123|101|P|   This medication may pass into breast milk. Consult your doctor||
9123|102|P|before breastfeeding.||
9123|103|B|||
9123|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9123|105|I|medications work or increase your risk for serious side effects.||
9123|106|I|This document does not contain all possible drug interactions.||
9123|107|I|Keep a list of all the products you use (including||
9123|108|I|prescription/nonprescription drugs and herbal products) and share||
9123|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
9123|110|I|the dosage of any medicines without your doctor's approval.||
9123|111|I|   Antacids can interfere with the absorption of many other||
9123|112|I|drugs. Be sure to check with your pharmacist before taking||
9123|113|I|antacids with any other medication.||
9123|114|B|||
9123|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9123|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9123|117|O|poison control center right away. US residents can call||
9123|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9123|119|B|||
9123|120|N|NOTES:  Keep all medical and lab appointments.||
9123|121|N|   Lifestyle changes such as stress reduction programs, stopping||
9123|122|N|smoking, limiting alcohol, and diet changes (such as avoiding||
9123|123|N|caffeine, fatty foods, certain spices) may increase the||
9123|124|N|effectiveness of this medication. Talk to your doctor or||
9123|125|N|pharmacist about lifestyle changes that might benefit you.||
9123|126|B|||
9123|127|D|MISSED DOSE:  If you are taking this product on a regular||
9123|128|D|schedule and miss a dose, take it as soon as you remember. If it||
9123|129|D|is near the time of the next dose, skip the missed dose. Take||
9123|130|D|your next dose at the regular time. Do not double the dose to||
9123|131|D|catch up.||
9123|132|B|||
9123|133|R|STORAGE:  Store at room temperature. This product may be stored||
9123|134|R|in the refrigerator to improve taste. Do not freeze. Keep all||
9123|135|R|medications away from children and pets.||
9123|136|R|   Do not flush medications down the toilet or pour them into a||
9123|137|R|drain unless instructed to do so. Properly discard this product||
9123|138|R|when it is expired or no longer needed. Consult your pharmacist||
9123|139|R|or local waste disposal company.||
9123|140|B|||
9123|141|A|Information last revised October 2025.||
9123|142|A|Copyright(c) 2025 First Databank, Inc.||
9123|143|B|||
9124|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9124|002|Z|does NOT have all possible information about this product. This||
9124|003|Z|information does not assure that this product is safe, effective,||
9124|004|Z|or appropriate for you. This information is not individual||
9124|005|Z|medical advice and does not substitute for the advice of your||
9124|006|Z|health care professional. Always ask your health care||
9124|007|Z|professional for complete information about this product and your||
9124|008|Z|specific health needs.||
9124|009|B|||
9124|010|T|MINOXIDIL - TOPICAL||
9124|011|F|(min-OX-id-ill)||
9124|012|B|||
9124|013|C|COMMON BRAND NAME(S): Rogaine||
9124|014|B|||
9124|015|U|USES:  Minoxidil solution and foam are used to help hair growth||
9124|016|U|in the treatment of male pattern baldness. It is not used for||
9124|017|U|baldness at the front of the scalp or receding hairline in men.||
9124|018|U|The foam and 2 percent minoxidil solution is also used to help||
9124|019|U|hair growth in women with thinning hair.||
9124|020|U|   Minoxidil belongs to a class of drugs known as vasodilators.||
9124|021|U|It is not known how minoxidil causes hair growth. This medication||
9124|022|U|is not used for sudden/patchy hair loss, unexplained hair loss||
9124|023|U|(for example, if you have no family history of hair loss), or||
9124|024|U|hair loss after giving birth.||
9124|025|U|   Do not use this product if you are 18 years old or younger.||
9124|026|B|||
9124|027|H|HOW TO USE:  Read and follow all directions on the product||
9124|028|H|package before using this product. If you have any questions, ask||
9124|029|H|your doctor or pharmacist.||
9124|030|H|   Clean and dry the scalp area before applying the medication.||
9124|031|H|You may apply this product to damp hair. To use the solution,||
9124|032|H|fill the applicator with 1 milliliter of medication (to the 1||
9124|033|H|milliliter line), or use 20 drops. Part your hair in the area of||
9124|034|H|thinning and apply the solution evenly to the affected area of||
9124|035|H|the scalp. Gently rub in. Allow the solution to dry completely||
9124|036|H|before using other styling products (such as gels, mousse) or||
9124|037|H|before going to bed.||
9124|038|H|   To use the foam, rinse your hands in cold water and dry well.||
9124|039|H|Apply about 1/2 capful of foam to the scalp and rub in gently.||
9124|040|H|Allow the foam to dry completely before styling or going to bed.||
9124|041|H|   If scalp irritation is a problem, you may need to avoid using||
9124|042|H|minoxidil on the same days that you have your hair colored or||
9124|043|H|chemically treated (for example, permed).||
9124|044|H|   Do not use on other parts of the body unless directed by your||
9124|045|H|doctor. Do not use on skin that is red, painful, irritated,||
9124|046|H|scraped, cut, or infected. Wash hands thoroughly after||
9124|047|H|application. Avoid getting the medication in your eyes. If this||
9124|048|H|occurs, rinse your eyes with large amounts of cool water.||
9124|049|H|   Do not use this medication more often, apply more of it than||
9124|050|H|as directed, or apply it to an irritated or sunburned scalp.||
9124|051|H|Doing so can cause the drug to be absorbed into your body and||
9124|052|H|result in serious side effects. This product may contain alcohol||
9124|053|H|and can be irritating and drying to the scalp. Ask your doctor or||
9124|054|H|pharmacist how to use this product safely.||
9124|055|H|   It takes time for hair to regrow. Most people need to use this||
9124|056|H|medication regularly for 4 months to see benefit. This medication||
9124|057|H|must be used continuously to maintain hair growth. Tell your||
9124|058|H|doctor if your condition does not get better or if it gets worse||
9124|059|H|after using this medication for 4 to 6 months. If you think you||
9124|060|H|may have a serious medical problem, get medical help right away.||
9124|061|B|||
9124|062|S|SIDE EFFECTS:  Burning, stinging, or redness at the application||
9124|063|S|site may occur. If any of these effects last or get worse, tell||
9124|064|S|your doctor or pharmacist promptly.||
9124|065|S|   If your doctor has directed you to use this medication,||
9124|066|S|remember that your doctor has judged that the benefit to you is||
9124|067|S|greater than the risk of side effects. Many people using this||
9124|068|S|medication do not have serious side effects.||
9124|069|S|   Rarely, this medication can be absorbed through the skin and||
9124|070|S|cause side effects. Stop using this medication and tell your||
9124|071|S|doctor right away if you have any serious side effects,||
9124|072|S|including: unwanted facial/body hair, dizziness, fast/irregular||
9124|073|S|heartbeat, fainting, chest pain, swelling of hands/feet, unusual||
9124|074|S|weight gain, tiredness, difficulty breathing especially when||
9124|075|S|lying down.||
9124|076|S|   A very serious allergic reaction to this drug is rare.||
9124|077|S|However, get medical help right away if you notice any symptoms||
9124|078|S|of a serious allergic reaction, including: rash, itching/swelling||
9124|079|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9124|080|S|breathing.||
9124|081|S|   This is not a complete list of possible side effects. If you||
9124|082|S|notice other effects not listed above, contact your doctor or||
9124|083|S|pharmacist.||
9124|084|S|   In the US -||
9124|085|S|   Call your doctor for medical advice about side effects. You||
9124|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9124|087|S|www.fda.gov/medwatch.||
9124|088|S|   In Canada - Call your doctor for medical advice about side||
9124|089|S|effects. You may report side effects to Health Canada at||
9124|090|S|1-866-234-2345.||
9124|091|B|||
9124|092|P|PRECAUTIONS:  Before using minoxidil, tell your doctor or||
9124|093|P|pharmacist if you are allergic to it; or if you have any other||
9124|094|P|allergies. This product may contain inactive ingredients, which||
9124|095|P|can cause allergic reactions or other problems. Talk to your||
9124|096|P|pharmacist for more details.||
9124|097|P|   If you have any of the following health problems, consult your||
9124|098|P|doctor or pharmacist before using this product: diseases of the||
9124|099|P|scalp (such as eczema, infection, cuts), heart problems (such as||
9124|100|P|chest pain, heart attack, heart failure), kidney disease, liver||
9124|101|P|disease.||
9124|102|P|   During pregnancy, this product should be used only when||
9124|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
9124|104|P|   It is unknown if this drug passes into breast milk. Consult||
9124|105|P|your doctor before breastfeeding.||
9124|106|B|||
9124|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9124|108|I|medications work or increase your risk for serious side effects.||
9124|109|I|This document does not contain all possible drug interactions.||
9124|110|I|Keep a list of all the products you use (including||
9124|111|I|prescription/nonprescription drugs and herbal products) and share||
9124|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
9124|113|I|the dosage of any medicines without your doctor's approval.||
9124|114|I|   Some products that may interact with this drug include: drugs||
9124|115|I|for high blood pressure (such as guanethidine), drugs that||
9124|116|I|interact with alcohol (such as disulfiram, metronidazole).||
9124|117|B|||
9124|118|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9124|119|O|has overdosed and has serious symptoms such as passing out or||
9124|120|O|trouble breathing, call 911. Otherwise, call a poison control||
9124|121|O|center right away. US residents can call 1-800-222-1222. Canada||
9124|122|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9124|123|O|include: dizziness, drowsiness, fainting, flushing.||
9124|124|B|||
9124|125|N|NOTES:  Keep all medical and lab appointments.||
9124|126|B|||
9124|127|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Use your||
9124|128|D|next dose at the regular time. Do not double the dose to catch||
9124|129|D|up.||
9124|130|B|||
9124|131|R|STORAGE:  Store at room temperature. This product is flammable.||
9124|132|R|Keep it away from heat and open flame. Keep all medications away||
9124|133|R|from children and pets.||
9124|134|R|   Do not flush medications down the toilet or pour them into a||
9124|135|R|drain unless instructed to do so. Properly discard this product||
9124|136|R|when it is expired or no longer needed. Consult your pharmacist||
9124|137|R|or local waste disposal company.||
9124|138|B|||
9124|139|A|Information last revised July 2025.||
9124|140|A|Copyright(c) 2025 First Databank, Inc.||
9124|141|B|||
9125|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9125|002|Z|does NOT have all possible information about this product. This||
9125|003|Z|information does not assure that this product is safe, effective,||
9125|004|Z|or appropriate for you. This information is not individual||
9125|005|Z|medical advice and does not substitute for the advice of your||
9125|006|Z|health care professional. Always ask your health care||
9125|007|Z|professional for complete information about this product and your||
9125|008|Z|specific health needs.||
9125|009|B|||
9125|010|T|BACITRACIN - TOPICAL||
9125|011|F|(BAS-i-TRAY-sin)||
9125|012|B|||
9125|013|C|COMMON BRAND NAME(S): Baciguent||
9125|014|B|||
9125|015|U|USES:  This medication is used to prevent minor skin infections||
9125|016|U|caused by small cuts, scrapes, or burns. Bacitracin works by||
9125|017|U|stopping the growth of certain bacteria. It belongs to a class of||
9125|018|U|drugs known as antibiotics.||
9125|019|U|   This antibiotic only prevents bacterial infections. It will||
9125|020|U|not work for virus or fungus infections. Unnecessary use or||
9125|021|U|overuse of any antibiotic can lead to its decreased||
9125|022|U|effectiveness.||
9125|023|U|   Do not use this product over large areas of the body. Do not||
9125|024|U|use it for serious skin infections. Ask your doctor first before||
9125|025|U|using this product for serious skin injuries (such as deep or||
9125|026|U|puncture wounds, animal bites, serious burns). A different||
9125|027|U|treatment may be necessary for these types of conditions. Consult||
9125|028|U|your doctor for more information.||
9125|029|U|   If you are self-treating with this medication, it is important||
9125|030|U|to read the package instructions carefully before you start using||
9125|031|U|this product to be sure it is right for you. (See also||
9125|032|U|Precautions section.)||
9125|033|B|||
9125|034|H|HOW TO USE:  This medication is for use on the skin only. If you||
9125|035|H|are self-treating, follow all directions on the product package.||
9125|036|H|If you have any questions, ask your doctor or pharmacist.||
9125|037|H|   Wash your hands before using. Clean and dry the affected area.||
9125|038|H|Then gently apply a small amount of medication (no more than can||
9125|039|H|fit on your finger tip) in a thin layer, usually 1 to 3 times a||
9125|040|H|day or as directed by your doctor. If you are using the spray||
9125|041|H|form, shake the bottle well before each use. You may cover the||
9125|042|H|area with a sterile bandage. Wash your hands after use.||
9125|043|H|   Avoid getting this medication in your eyes, nose, or mouth. If||
9125|044|H|this occurs, wipe off the medication and rinse thoroughly with||
9125|045|H|water.||
9125|046|H|   Use this medication regularly to get the most benefit from it.||
9125|047|H|To help you remember, use it at the same time(s) each day. Do not||
9125|048|H|apply large amounts of this medication, use it more often, or use||
9125|049|H|it for longer than directed. Your condition will not improve any||
9125|050|H|faster, and your risk of side effects may increase. Do not use||
9125|051|H|this product for longer than 1 week unless directed by your||
9125|052|H|doctor.||
9125|053|H|   Stop using this medication and tell your doctor right away if||
9125|054|H|your condition lasts after a few days, or if it gets worse, or if||
9125|055|H|you develop a rash or an allergic reaction. (See Side Effects||
9125|056|H|Section.) If you think you may have a serious medical problem,||
9125|057|H|medical help right away.||
9125|058|B|||
9125|059|S|SIDE EFFECTS:  This medication usually has no side effects. If||
9125|060|S|you have any unusual effects, contact your doctor or pharmacist||
9125|061|S|promptly.||
9125|062|S|   If your doctor has directed you to use this medication,||
9125|063|S|remember that your doctor has judged that the benefit to you is||
9125|064|S|greater than the risk of side effects. Many people using this||
9125|065|S|medication do not have serious side effects.||
9125|066|S|   Rarely, use of this medication for prolonged or repeated||
9125|067|S|periods may result in other types of skin infections (such as||
9125|068|S|fungal or other bacterial infections). Contact your doctor if you||
9125|069|S|notice any unusual skin symptoms or if your condition does not||
9125|070|S|improve.||
9125|071|S|   A very serious allergic reaction to this drug is rare.||
9125|072|S|However, get medical help right away if you notice any symptoms||
9125|073|S|of a serious allergic reaction, including: rash, itching/swelling||
9125|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9125|075|S|breathing.||
9125|076|S|   This is not a complete list of possible side effects. If you||
9125|077|S|notice other effects not listed above, contact your doctor or||
9125|078|S|pharmacist.||
9125|079|S|   In the US -||
9125|080|S|   Call your doctor for medical advice about side effects. You||
9125|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9125|082|S|www.fda.gov/medwatch.||
9125|083|S|   In Canada - Call your doctor for medical advice about side||
9125|084|S|effects. You may report side effects to Health Canada at||
9125|085|S|1-866-234-2345.||
9125|086|B|||
9125|087|P|PRECAUTIONS:  Before using bacitracin, tell your doctor or||
9125|088|P|pharmacist if you are allergic to it; or to neomycin; or if you||
9125|089|P|have any other allergies. This product may contain inactive||
9125|090|P|ingredients, which can cause allergic reactions or other||
9125|091|P|problems. Talk to your pharmacist for more details.||
9125|092|P|   Before using this medication, tell your doctor or pharmacist||
9125|093|P|your medical history.||
9125|094|P|   Before having surgery, tell your doctor or dentist about all||
9125|095|P|the products you use (including prescription drugs,||
9125|096|P|nonprescription drugs, and herbal products).||
9125|097|P|   During pregnancy, this medication should be used only when||
9125|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
9125|099|P|   It is unknown if this medication passes into breast milk.||
9125|100|P|Consult your doctor before breastfeeding.||
9125|101|B|||
9125|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9125|103|I|medications work or increase your risk for serious side effects.||
9125|104|I|This document does not contain all possible drug interactions.||
9125|105|I|Keep a list of all the products you use (including||
9125|106|I|prescription/nonprescription drugs and herbal products) and share||
9125|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
9125|108|I|the dosage of any medicines without your doctor's approval.||
9125|109|B|||
9125|110|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9125|111|O|has overdosed and has serious symptoms such as passing out or||
9125|112|O|trouble breathing, call 911. Otherwise, call a poison control||
9125|113|O|center right away. US residents can call 1-800-222-1222. Canada||
9125|114|O|residents can call 1-844-764-7669.||
9125|115|B|||
9125|116|N|NOTES:  Keep all medical and lab appointments.||
9125|117|B|||
9125|118|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9125|119|D|If it is near the time of the next dose, skip the missed dose.||
9125|120|D|Use your next dose at the regular time. Do not double the dose to||
9125|121|D|catch up.||
9125|122|B|||
9125|123|R|STORAGE:  Store at room temperature. Different forms of this||
9125|124|R|medication may have different storage requirements. Read the||
9125|125|R|package labeling or ask your pharmacist for the storage||
9125|126|R|requirements for the product you are using. Keep all medications||
9125|127|R|away from children and pets.||
9125|128|R|   Do not flush medications down the toilet or pour them into a||
9125|129|R|drain unless instructed to do so. Properly discard this product||
9125|130|R|when it is expired or no longer needed. Consult your pharmacist||
9125|131|R|or local waste disposal company.||
9125|132|B|||
9125|133|A|Information last revised May 2024.||
9125|134|A|Copyright(c) 2025 First Databank, Inc.||
9125|135|B|||
9126|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9126|002|Z|does NOT have all possible information about this product. This||
9126|003|Z|information does not assure that this product is safe, effective,||
9126|004|Z|or appropriate for you. This information is not individual||
9126|005|Z|medical advice and does not substitute for the advice of your||
9126|006|Z|health care professional. Always ask your health care||
9126|007|Z|professional for complete information about this product and your||
9126|008|Z|specific health needs.||
9126|009|B|||
9126|010|T|NIACIN EXTENDED-RELEASE - ORAL||
9126|011|F|(NYE-a-sin)||
9126|012|B|||
9126|013|C|COMMON BRAND NAME(S): Niaspan||
9126|014|B|||
9126|015|U|USES:  Niacin is used with a proper diet and exercise program to||
9126|016|U|help lower "bad" cholesterol and fats (LDL, triglycerides) and||
9126|017|U|raise "good" cholesterol (HDL) in the blood. It is generally used||
9126|018|U|after non-drug treatments have not been fully successful at||
9126|019|U|lowering cholesterol. Niacin is also known as vitamin B-3||
9126|020|U|(nicotinic acid), one of the B-complex vitamins. It may be used||
9126|021|U|with or without other medications. Lowering "bad"||
9126|022|U|cholesterol/triglycerides and raising "good" cholesterol helps||
9126|023|U|prevent strokes and heart attacks. Lowering fats may also help||
9126|024|U|reduce the risk of pancreas problems (pancreatitis) in people at||
9126|025|U|risk.||
9126|026|U|   In addition to eating a proper diet (such as a||
9126|027|U|low-cholesterol/low-fat diet), other lifestyle changes that may||
9126|028|U|help this medication work better include exercising, losing||
9126|029|U|weight if overweight, and stopping smoking. Consult your doctor||
9126|030|U|for more details.||
9126|031|B|||
9126|032|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9126|033|H|from your pharmacist before you start taking niacin and each time||
9126|034|H|you get a refill. If you have any questions, ask your doctor or||
9126|035|H|pharmacist.||
9126|036|H|   Take this medication by mouth with a low-fat meal or snack as||
9126|037|H|directed by your doctor, usually at bedtime. Taking niacin on an||
9126|038|H|empty stomach increases side effects (such as flushing, upset||
9126|039|H|stomach). Swallow the tablets whole. Do not crush or chew the||
9126|040|H|tablets. Doing so can release all of the drug at once, increasing||
9126|041|H|the risk of side effects.||
9126|042|H|   Niacin is available in different formulations (such as||
9126|043|H|immediate and sustained release). Do not switch between||
9126|044|H|strengths, brands, or forms of niacin. Severe liver problems may||
9126|045|H|occur.||
9126|046|H|   The dosage is based on your medical condition and response to||
9126|047|H|treatment. To reduce your risk of side effects, your doctor may||
9126|048|H|direct you to start this medication at a low dose and gradually||
9126|049|H|increase your dose. Your dose will need to be increased slowly,||
9126|050|H|even if you are already taking niacin and are being switched from||
9126|051|H|another niacin product (such as immediate-release tablets) to||
9126|052|H|this product. Follow your doctor's instructions carefully.||
9126|053|H|   If you also take certain other drugs to lower your cholesterol||
9126|054|H|(bile acid-binding resins such as cholestyramine or colestipol),||
9126|055|H|take niacin at least 4-6 hours before or after taking these||
9126|056|H|medications. These products can react with niacin, preventing its||
9126|057|H|full absorption. Continue to take other medications to lower your||
9126|058|H|cholesterol as directed by your doctor.||
9126|059|H|   To lessen the chance of side effects such as flushing, avoid||
9126|060|H|alcohol, hot beverages, and eating spicy foods near the time you||
9126|061|H|take niacin. Taking a plain (non-enteric coated, 325 milligram)||
9126|062|H|aspirin or a nonsteroidal anti-inflammatory drug (such as||
9126|063|H|ibuprofen, 200 milligrams) 30 minutes before taking niacin may||
9126|064|H|help prevent flushing. Ask your doctor if this treatment is right||
9126|065|H|for you.||
9126|066|H|   Use this medication regularly to get the most benefit from it.||
9126|067|H|To help you remember, take it at the same time each day. Keep||
9126|068|H|taking this medication even if you feel well. Most people with||
9126|069|H|high cholesterol do not feel sick.||
9126|070|H|   Do not stop taking this medication without consulting your||
9126|071|H|doctor. If you stop taking niacin, you may need to return to your||
9126|072|H|original dose and gradually increase it again. Ask your doctor or||
9126|073|H|pharmacist for instructions on restarting your dose if you have||
9126|074|H|not taken your medication for an extended period (more than 7||
9126|075|H|days).||
9126|076|H|   It is very important to continue to follow your doctor's||
9126|077|H|advice about diet and exercise.||
9126|078|B|||
9126|079|S|SIDE EFFECTS:  Flushing of the face and neck along with warmth,||
9126|080|S|headache, itching, burning, sweating, chills, or tingling may||
9126|081|S|occur within 2-4 hours of taking this medication. Flushing may||
9126|082|S|last for a few hours after use. These effects should improve or||
9126|083|S|go away as your body adjusts to the medication. Dizziness,||
9126|084|S|stomach upset, heartburn, nausea, vomiting, and diarrhea may also||
9126|085|S|occur. If any of these effects last or get worse, tell your||
9126|086|S|doctor or pharmacist promptly.||
9126|087|S|   To reduce the risk of dizziness and lightheadedness, get up||
9126|088|S|slowly when rising from a sitting or lying position. This is very||
9126|089|S|important if you are also taking medications to lower your blood||
9126|090|S|pressure.||
9126|091|S|   Remember that this medication has been prescribed because your||
9126|092|S|doctor has judged that the benefit to you is greater than the||
9126|093|S|risk of side effects. Many people using this medication do not||
9126|094|S|have serious side effects.||
9126|095|S|   Tell your doctor right away if you have any serious side||
9126|096|S|effects, including: nausea/vomiting that doesn't stop,||
9126|097|S|fast/irregular heartbeat, severe headache (migraine), unusual||
9126|098|S|joint pain, swelling of legs/arms, vision problems, severe||
9126|099|S|stomach/abdominal pain, black stools, easy bruising/bleeding,||
9126|100|S|unexplained muscle pain/tenderness/weakness, signs of kidney||
9126|101|S|problems (such as change in the amount of urine), dark urine,||
9126|102|S|vomit that looks like coffee grounds, yellowing eyes/skin.||
9126|103|S|   A very serious allergic reaction to this drug is rare.||
9126|104|S|However, get medical help right away if you notice any symptoms||
9126|105|S|of a serious allergic reaction, including: rash, itching/swelling||
9126|106|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9126|107|S|breathing.||
9126|108|S|   This is not a complete list of possible side effects. If you||
9126|109|S|notice other effects not listed above, contact your doctor or||
9126|110|S|pharmacist.||
9126|111|S|   In the US -||
9126|112|S|   Call your doctor for medical advice about side effects. You||
9126|113|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9126|114|S|www.fda.gov/medwatch.||
9126|115|S|   In Canada - Call your doctor for medical advice about side||
9126|116|S|effects. You may report side effects to Health Canada at||
9126|117|S|1-866-234-2345.||
9126|118|B|||
9126|119|P|PRECAUTIONS:  Before taking niacin, tell your doctor or||
9126|120|P|pharmacist if you are allergic to it; or if you have any other||
9126|121|P|allergies. This product may contain inactive ingredients, which||
9126|122|P|can cause allergic reactions or other problems. Talk to your||
9126|123|P|pharmacist for more details.||
9126|124|P|   Before using this medication, tell your doctor or pharmacist||
9126|125|P|your medical history, especially of: very low blood pressure,||
9126|126|P|alcohol use, bleeding problems (such as low platelets), diabetes,||
9126|127|P|gallbladder disease, glaucoma, gout, heart disease (such as||
9126|128|P|recent heart attack, unstable angina), kidney disease, liver||
9126|129|P|disease/increase in liver enzymes, untreated mineral imbalance||
9126|130|P|(low phosphate levels), stomach/intestinal ulcers, underactive||
9126|131|P|thyroid (hypothyroidism).||
9126|132|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9126|133|P|can make you more dizzy. Do not drive, use machinery, or do||
9126|134|P|anything that needs alertness until you can do it safely. Limit||
9126|135|P|alcoholic beverages. Talk to your doctor if you are using||
9126|136|P|marijuana (cannabis).||
9126|137|P|   Before having surgery, tell your doctor or dentist about all||
9126|138|P|the products you use (including prescription drugs,||
9126|139|P|nonprescription drugs, and herbal products).||
9126|140|P|   This medication may rarely make your blood sugar rise, which||
9126|141|P|can cause or worsen diabetes. If you already have diabetes, check||
9126|142|P|your blood sugar regularly as directed and share the results with||
9126|143|P|your doctor. Tell your doctor right away if you have symptoms of||
9126|144|P|high blood sugar such as increased thirst/urination. Your doctor||
9126|145|P|may need to adjust your diabetes medication, exercise program, or||
9126|146|P|diet.||
9126|147|P|   During pregnancy, this medication should be used only when||
9126|148|P|clearly needed. Discuss the risks and benefits with your doctor.||
9126|149|P|   This medication passes into breast milk. Consult your doctor||
9126|150|P|before breastfeeding.||
9126|151|B|||
9126|152|I|DRUG INTERACTIONS:  See also How to Use section.||
9126|153|I|   Drug interactions may change how your medications work or||
9126|154|I|increase your risk for serious side effects. This document does||
9126|155|I|not contain all possible drug interactions. Keep a list of all||
9126|156|I|the products you use (including prescription/nonprescription||
9126|157|I|drugs and herbal products) and share it with your doctor and||
9126|158|I|pharmacist. Do not start, stop, or change the dosage of any||
9126|159|I|medicines without your doctor's approval.||
9126|160|I|   Check all prescription and nonprescription medicine labels||
9126|161|I|carefully since vitamins/dietary supplements may also contain||
9126|162|I|niacin or nicotinamide. These may increase your risk of side||
9126|163|I|effects if taken together. Ask your doctor or pharmacist for more||
9126|164|I|details.||
9126|165|I|   This medication may interfere with certain lab tests||
9126|166|I|(including urine or blood catecholamines, copper-based urine||
9126|167|I|glucose tests), possibly causing false test results. Make sure||
9126|168|I|lab personnel and all your doctors know you use this drug.||
9126|169|B|||
9126|170|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9126|171|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9126|172|O|poison control center right away. US residents can call||
9126|173|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9126|174|B|||
9126|175|N|NOTES:  Do not share this medication with others.||
9126|176|N|   Lab tests (such as blood lipids, blood sugar, liver function)||
9126|177|N|should be done while you are taking this medication. Keep all||
9126|178|N|medical and lab appointments.||
9126|179|B|||
9126|180|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9126|181|D|remember. If it is near the time of the next dose, skip the||
9126|182|D|missed dose. Take your next dose at the regular time. Do not||
9126|183|D|double the dose to catch up.||
9126|184|B|||
9126|185|R|STORAGE:  Store at room temperature away from light and moisture.||
9126|186|R|Do not store in the bathroom. Keep all medications away from||
9126|187|R|children and pets.||
9126|188|R|   Do not flush medications down the toilet or pour them into a||
9126|189|R|drain unless instructed to do so. Properly discard this product||
9126|190|R|when it is expired or no longer needed. Consult your pharmacist||
9126|191|R|or local waste disposal company.||
9126|192|B|||
9126|193|A|Information last revised May 2024.||
9126|194|A|Copyright(c) 2025 First Databank, Inc.||
9126|195|B|||
9128|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9128|002|Z|does NOT have all possible information about this product. This||
9128|003|Z|information does not assure that this product is safe, effective,||
9128|004|Z|or appropriate for you. This information is not individual||
9128|005|Z|medical advice and does not substitute for the advice of your||
9128|006|Z|health care professional. Always ask your health care||
9128|007|Z|professional for complete information about this product and your||
9128|008|Z|specific health needs.||
9128|009|B|||
9128|010|T|MEFLOQUINE - ORAL||
9128|011|F|(MEFF-low-kwin)||
9128|012|B|||
9128|013|C|COMMON BRAND NAME(S): Lariam||
9128|014|B|||
9128|015|W|WARNING:  Mefloquine may cause mental/mood or nervous system||
9128|016|W|problems. Tell your doctor right away if you have any of these||
9128|017|W|serious side effects, including: mental/mood changes (such as||
9128|018|W|anxiety, depression, restlessness, confusion, hallucinations,||
9128|019|W|suicidal thoughts/attempts), ringing in the ears, dizziness,||
9128|020|W|lightheadedness, loss of balance, or trouble sleeping. These side||
9128|021|W|effects may continue to occur even after stopping mefloquine and||
9128|022|W|certain side effects (such as dizziness, ringing in the ears,||
9128|023|W|loss of balance) may become permanent. This medication should not||
9128|024|W|be used to prevent malaria in people who have mental/mood||
9128|025|W|disorders (such as depression, schizophrenia).||
9128|026|B|||
9128|027|U|USES:  This medication is used to treat and prevent malaria.||
9128|028|B|||
9128|029|H|HOW TO USE:  Read the Medication Guide provided by your||
9128|030|H|pharmacist before you start taking mefloquine and each time you||
9128|031|H|get a refill. If you have any questions, ask your doctor or||
9128|032|H|pharmacist. Carry the information wallet card with you at all||
9128|033|H|times.||
9128|034|H|   Take this medication by mouth as directed by your doctor. Take||
9128|035|H|it with food or milk to prevent stomach upset. Do not take the||
9128|036|H|medication on an empty stomach. Take each dose of this medication||
9128|037|H|with a full glass (8 ounces or 240 milliliters) of water. If you||
9128|038|H|have trouble swallowing the medication, the tablet may be crushed||
9128|039|H|and placed in a small amount of water, milk, or other beverage.||
9128|040|H|   Children's dosage is based on weight. Early vomiting may occur||
9128|041|H|in children after taking mefloquine. If vomiting occurs in your||
9128|042|H|child after taking this medication, call the doctor right away to||
9128|043|H|see if your child needs to take another dose of the medication.||
9128|044|H|If vomiting continues, check with your doctor for a different||
9128|045|H|medication to use in place of mefloquine.||
9128|046|H|   When using this medication to prevent malaria, it is usually||
9128|047|H|taken once a week. The first dose of this medication should be||
9128|048|H|taken one week before travel, or as directed by your doctor.||
9128|049|H|   Take this medication as prescribed for the full course of||
9128|050|H|treatment. It is important that you do not miss any doses and||
9128|051|H|that you take the drug on a regularly scheduled basis. Remember||
9128|052|H|to take it on the same day each week.||
9128|053|H|   Upon returning from the malaria area, you should keep taking||
9128|054|H|this medication for 4 more weeks. If you are unable to finish||
9128|055|H|this course of mefloquine, contact your doctor.||
9128|056|H|   If this medication is being used for prevention of malaria, it||
9128|057|H|is important to understand that it is still possible to contract||
9128|058|H|the disease. Tell your doctor right away if you develop a fever.||
9128|059|H|Malaria is best treated if treatment is started early.||
9128|060|B|||
9128|061|S|SIDE EFFECTS:  See also Warning section.||
9128|062|S|   Stomach upset/pain, loss of appetite, nausea/vomiting,||
9128|063|S|headache, muscle pain, or diarrhea may occur. If any of these||
9128|064|S|effects last or get worse, tell your doctor promptly.||
9128|065|S|   Remember that this medication has been prescribed because your||
9128|066|S|doctor has judged that the benefit to you is greater than the||
9128|067|S|risk of side effects. Many people using this medication do not||
9128|068|S|have serious side effects.||
9128|069|S|   Tell your doctor right away if you have any serious side||
9128|070|S|effects, including: loss of coordination, numbness/tingling/pain||
9128|071|S|of hands or feet, vision changes, unusual tiredness, signs of||
9128|072|S|liver disease (such as nausea/vomiting that doesn't stop, dark||
9128|073|S|urine, yellowing eyes/skin).||
9128|074|S|   Get medical help right away if you have any very serious side||
9128|075|S|effects, including: fast/slow/irregular heartbeat, fainting,||
9128|076|S|seizures.||
9128|077|S|   A very serious allergic reaction to this drug is rare.||
9128|078|S|However, get medical help right away if you notice any symptoms||
9128|079|S|of a serious allergic reaction, including: rash, itching/swelling||
9128|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9128|081|S|breathing.||
9128|082|S|   This is not a complete list of possible side effects. If you||
9128|083|S|notice other effects not listed above, contact your doctor or||
9128|084|S|pharmacist.||
9128|085|S|   In the US -||
9128|086|S|   Call your doctor for medical advice about side effects. You||
9128|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9128|088|S|www.fda.gov/medwatch.||
9128|089|S|   In Canada - Call your doctor for medical advice about side||
9128|090|S|effects. You may report side effects to Health Canada at||
9128|091|S|1-866-234-2345.||
9128|092|B|||
9128|093|P|PRECAUTIONS:  Before taking mefloquine, tell your doctor or||
9128|094|P|pharmacist if you are allergic to it; or to quinine or quinidine;||
9128|095|P|or if you have any other allergies. This product may contain||
9128|096|P|inactive ingredients, which can cause allergic reactions or other||
9128|097|P|problems. Talk to your pharmacist for more details.||
9128|098|P|   Before using this medication, tell your doctor or pharmacist||
9128|099|P|your medical history, especially of: mental/mood disorders (such||
9128|100|P|as depression, anxiety, schizophrenia), seizures, heart problems,||
9128|101|P|liver disorder.||
9128|102|P|   This drug may make you dizzy or lose your balance. Alcohol or||
9128|103|P|marijuana (cannabis) can make you more dizzy. Do not drive, use||
9128|104|P|machinery, or do anything that needs alertness until you can do||
9128|105|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9128|106|P|are using marijuana (cannabis).||
9128|107|P|   Before having surgery, tell your doctor or dentist about all||
9128|108|P|the products you use (including prescription drugs,||
9128|109|P|nonprescription drugs, and herbal products).||
9128|110|P|   Mefloquine may cause live bacterial vaccines (such as typhoid||
9128|111|P|vaccine) not to work well. Tell your health care professional||
9128|112|P|that you are using mefloquine before having any||
9128|113|P|immunizations/vaccinations.||
9128|114|P|   During pregnancy, this medication should be used only when||
9128|115|P|clearly needed. Discuss the risks and benefits with your doctor.||
9128|116|P|   This drug passes into breast milk. Consult your doctor before||
9128|117|P|breastfeeding.||
9128|118|B|||
9128|119|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9128|120|I|medications work or increase your risk for serious side effects.||
9128|121|I|This document does not contain all possible drug interactions.||
9128|122|I|Keep a list of all the products you use (including||
9128|123|I|prescription/nonprescription drugs and herbal products) and share||
9128|124|I|it with your doctor and pharmacist. Do not start, stop, or change||
9128|125|I|the dosage of any medicines without your doctor's approval.||
9128|126|I|   Some products that may interact with this drug include:||
9128|127|I|artemether-lumefantrine, chloroquine, hydroxychloroquine,||
9128|128|I|ketoconazole, quinidine, quinine, drugs for seizures (such as||
9128|129|I|phenytoin, valproic acid), ziprasidone.||
9128|130|I|   Do not take ketoconazole for 15 weeks after your last dose of||
9128|131|I|mefloquine.||
9128|132|I|   Other medications can affect the removal of mefloquine from||
9128|133|I|your body, which may affect how mefloquine works. Examples||
9128|134|I|include rifamycins (such as rifabutin), azole antifungals (such||
9128|135|I|as itraconazole), among others.||
9128|136|B|||
9128|137|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9128|138|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9128|139|O|poison control center right away. US residents can call||
9128|140|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9128|141|B|||
9128|142|N|NOTES:  Do not share this medication with others.||
9128|143|N|   It is important to wear protective clothing, insect repellent,||
9128|144|N|and use bednets when trying to prevent malaria.||
9128|145|N|   If you are taking this medication for a long time, lab and/or||
9128|146|N|medical tests (such as eye exams, liver function) should be done||
9128|147|N|while you are taking this medication. Keep all medical and lab||
9128|148|N|appointments. Consult your doctor for more details.||
9128|149|B|||
9128|150|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9128|151|D|remember. If it is near the time of the next dose, skip the||
9128|152|D|missed dose. Take your next dose at the regular time. Do not||
9128|153|D|double the dose to catch up.||
9128|154|B|||
9128|155|R|STORAGE:  Store at room temperature away from light and moisture.||
9128|156|R|Do not store in bathroom. Keep all medications away from children||
9128|157|R|and pets.||
9128|158|R|   Do not flush medications down the toilet or pour them into a||
9128|159|R|drain unless instructed to do so. Properly discard this product||
9128|160|R|when it is expired or no longer needed. Consult your pharmacist||
9128|161|R|or local waste disposal company.||
9128|162|B|||
9128|163|A|Information last revised May 2025.||
9128|164|A|Copyright(c) 2025 First Databank, Inc.||
9128|165|B|||
9130|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9130|002|Z|does NOT have all possible information about this product. This||
9130|003|Z|information does not assure that this product is safe, effective,||
9130|004|Z|or appropriate for you. This information is not individual||
9130|005|Z|medical advice and does not substitute for the advice of your||
9130|006|Z|health care professional. Always ask your health care||
9130|007|Z|professional for complete information about this product and your||
9130|008|Z|specific health needs.||
9130|009|B|||
9130|010|T|MAFENIDE CREAM - TOPICAL||
9130|011|F|(MAF-en-ide AS-e-tate)||
9130|012|B|||
9130|013|C|COMMON BRAND NAME(S): Sulfamylon||
9130|014|B|||
9130|015|U|USES:  This medication is used alone or with other medications to||
9130|016|U|help prevent and treat wound infections in patients with severe||
9130|017|U|burns. Mafenide is a drug applied to the skin that belongs to a||
9130|018|U|class of drugs known as sulfa antibiotics. It works by killing||
9130|019|U|bacteria that may infect an open wound. Killing bacteria helps to||
9130|020|U|promote wound healing and to decrease the risk of the bacteria||
9130|021|U|spreading to surrounding skin or to the blood, thereby helping to||
9130|022|U|prevent a serious blood infection (sepsis).||
9130|023|B|||
9130|024|H|HOW TO USE:  Wash hands before and after using this medication.||
9130|025|H|Use this medication on the skin only. After cleaning the affected||
9130|026|H|area, wear a clean pair of medical gloves (such as latex, vinyl)||
9130|027|H|and apply this medication to the wound as directed by your||
9130|028|H|doctor, usually once or twice daily. The layer of cream should be||
9130|029|H|about one-sixteenth of an inch (1 to 2 millimeters) thick. The||
9130|030|H|wound should be covered with this medication at all times.||
9130|031|H|Bandages do not need to be used to cover the wound. If some of||
9130|032|H|the cream rubs off the wound, re-apply it right away. Length of||
9130|033|H|treatment is based on your medical condition and response to||
9130|034|H|treatment.||
9130|035|H|   Do not stop using this medication until told to do so by your||
9130|036|H|doctor.||
9130|037|H|   If possible, bathe at least once a day to help remove the dead||
9130|038|H|skin from the wound to allow healing to occur. Be sure to||
9130|039|H|re-apply this medication after bathing.||
9130|040|H|   Use this medication regularly in order to get the most benefit||
9130|041|H|from it. To help you remember, use it at the same time(s) each||
9130|042|H|day.||
9130|043|H|   Tell your doctor if your condition lasts or gets worse or if||
9130|044|H|you notice increasing redness/tenderness of the skin around the||
9130|045|H|wound.||
9130|046|B|||
9130|047|S|SIDE EFFECTS:  Pain, burning, or redness may occur. If any of||
9130|048|S|these effects last or get worse, tell your doctor or pharmacist||
9130|049|S|promptly.||
9130|050|S|   Remember that this medication has been prescribed because your||
9130|051|S|doctor has judged that the benefit to you is greater than the||
9130|052|S|risk of side effects. Many people using this medication do not||
9130|053|S|have serious side effects.||
9130|054|S|   Tell your doctor right away if you have any serious side||
9130|055|S|effects, including: blisters, bleeding, fast breathing, nausea,||
9130|056|S|vomiting, diarrhea, headache, change in alertness, shaking||
9130|057|S|(tremors), seizures, weakness, dark urine, stomach/abdominal||
9130|058|S|pain, arm/leg/back pain, fast heartbeat.||
9130|059|S|   A very serious allergic reaction to this drug is rare.||
9130|060|S|However, get medical help right away if you notice any symptoms||
9130|061|S|of a serious allergic reaction, including: rash, itching/swelling||
9130|062|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9130|063|S|breathing.||
9130|064|S|   This is not a complete list of possible side effects. If you||
9130|065|S|notice other effects not listed above, contact your doctor or||
9130|066|S|pharmacist.||
9130|067|S|   In the US -||
9130|068|S|   Call your doctor for medical advice about side effects. You||
9130|069|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9130|070|S|www.fda.gov/medwatch.||
9130|071|S|   In Canada - Call your doctor for medical advice about side||
9130|072|S|effects. You may report side effects to Health Canada at||
9130|073|S|1-866-234-2345.||
9130|074|B|||
9130|075|P|PRECAUTIONS:  Before using mafenide, tell your doctor or||
9130|076|P|pharmacist if you are allergic to it; or if you have any other||
9130|077|P|allergies. This product may contain inactive ingredients||
9130|078|P|(including preservatives such as parabens, sulfites), which can||
9130|079|P|cause allergic reactions or other problems. Talk to your||
9130|080|P|pharmacist for more details.||
9130|081|P|   Before using this medication, tell your doctor or pharmacist||
9130|082|P|your medical history, especially of: lung problems (such as||
9130|083|P|asthma), kidney disease, metabolism problems (such as||
9130|084|P|glucose-6-phosphate dehydrogenase deficiency-G6PD), blood||
9130|085|P|disorders.||
9130|086|P|   During pregnancy, this medication should be used only when||
9130|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
9130|088|P|   It is unknown if this drug passes into breast milk. Consult||
9130|089|P|your doctor before breastfeeding.||
9130|090|B|||
9130|091|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9130|092|I|medications work or increase your risk for serious side effects.||
9130|093|I|This document does not contain all possible drug interactions.||
9130|094|I|Keep a list of all the products you use (including||
9130|095|I|prescription/nonprescription drugs and herbal products) and share||
9130|096|I|it with your doctor and pharmacist. Do not start, stop, or change||
9130|097|I|the dosage of any medicines without your doctor's approval.||
9130|098|B|||
9130|099|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9130|100|O|has overdosed and has serious symptoms such as passing out or||
9130|101|O|trouble breathing, call 911. Otherwise, call a poison control||
9130|102|O|center right away. US residents can call 1-800-222-1222. Canada||
9130|103|O|residents can call 1-844-764-7669. Symptoms following swallowing||
9130|104|O|may include: diarrhea.||
9130|105|B|||
9130|106|N|NOTES:  Do not share this medication with others.||
9130|107|N|   This medication has been prescribed for your current condition||
9130|108|N|only. Do not use it later on other wounds unless told to do so by||
9130|109|N|your doctor. A different medication may be necessary in that||
9130|110|N|case.||
9130|111|N|   Lab and/or medical tests (such as wound cultures, acid-base||
9130|112|N|balance, complete blood counts) should be done while you are||
9130|113|N|using this medication. Keep all medical and lab appointments.||
9130|114|N|Consult your doctor for more details.||
9130|115|B|||
9130|116|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9130|117|D|If it is near the time of the next dose, skip the missed dose.||
9130|118|D|Use your next dose at the regular time. Do not double the dose to||
9130|119|D|catch up.||
9130|120|B|||
9130|121|R|STORAGE:  Store at room temperature. Keep all medications away||
9130|122|R|from children and pets.||
9130|123|R|   Do not flush medications down the toilet or pour them into a||
9130|124|R|drain unless instructed to do so. Properly discard this product||
9130|125|R|when it is expired or no longer needed. Consult your pharmacist||
9130|126|R|or local waste disposal company.||
9130|127|B|||
9130|128|A|Information last revised May 2024.||
9130|129|A|Copyright(c) 2025 First Databank, Inc.||
9130|130|B|||
9131|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9131|002|Z|does NOT have all possible information about this product. This||
9131|003|Z|information does not assure that this product is safe, effective,||
9131|004|Z|or appropriate for you. This information is not individual||
9131|005|Z|medical advice and does not substitute for the advice of your||
9131|006|Z|health care professional. Always ask your health care||
9131|007|Z|professional for complete information about this product and your||
9131|008|Z|specific health needs.||
9131|009|B|||
9131|010|T|THIAMINE - INJECTION||
9131|011|F|(THIGH-uh-min)||
9131|012|B|||
9131|013|U|USES:  This medication is used to treat or prevent a lack of||
9131|014|U|thiamine (deficiency) when the form taken by mouth cannot be used||
9131|015|U|or would not work as well as the injection. Thiamine is a B||
9131|016|U|vitamin that helps your body to use carbohydrates for energy. It||
9131|017|U|is also important for normal function of your heart, muscles, and||
9131|018|U|nervous system. Most people get enough thiamine in their diet,||
9131|019|U|but certain health conditions (such as alcoholism, poor||
9131|020|U|nutrition, pregnancy, stomach/intestinal diseases) can cause a||
9131|021|U|deficiency in thiamine. Serious thiamine deficiency can lead to||
9131|022|U|nerve damage, heart failure, and mental/mood conditions (such as||
9131|023|U|confusion, psychosis).||
9131|024|B|||
9131|025|H|HOW TO USE:  This medication is given by injection into a muscle||
9131|026|H|or vein as directed by your doctor. The dosage is based on your||
9131|027|H|medical condition and response to treatment.||
9131|028|H|   If you are giving this medication to yourself at home, learn||
9131|029|H|all preparation and usage instructions from your health care||
9131|030|H|professional. Before using, check this product for particles or||
9131|031|H|discoloration. If either is present, do not use the liquid. Learn||
9131|032|H|how to store and discard medical supplies safely.||
9131|033|B|||
9131|034|S|SIDE EFFECTS:  Pain/redness/soreness at the injection site may||
9131|035|S|occur. This medication may also rarely cause nausea,||
9131|036|S|restlessness, feelings of warmth, sweating, or weakness. If any||
9131|037|S|of these effects last or get worse, tell your doctor or||
9131|038|S|pharmacist promptly.||
9131|039|S|   Remember that this medication has been prescribed because your||
9131|040|S|doctor has judged that the benefit to you is greater than the||
9131|041|S|risk of side effects. Many people using this medication do not||
9131|042|S|have serious side effects.||
9131|043|S|   Tell your doctor right away if you have any serious side||
9131|044|S|effects, including: bluish lips/skin/nails, dark/tarry stools.||
9131|045|S|   A very serious allergic reaction to this drug is rare.||
9131|046|S|However, get medical help right away if you notice any symptoms||
9131|047|S|of a serious allergic reaction, including: rash, itching/swelling||
9131|048|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9131|049|S|breathing.||
9131|050|S|   This is not a complete list of possible side effects. If you||
9131|051|S|notice other effects not listed above, contact your doctor or||
9131|052|S|pharmacist.||
9131|053|S|   In the US -||
9131|054|S|   Call your doctor for medical advice about side effects. You||
9131|055|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9131|056|S|www.fda.gov/medwatch.||
9131|057|S|   In Canada - Call your doctor for medical advice about side||
9131|058|S|effects. You may report side effects to Health Canada at||
9131|059|S|1-866-234-2345.||
9131|060|B|||
9131|061|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
9131|062|P|pharmacist if you have had any previous reaction to thiamine; or||
9131|063|P|if you have any other allergies. Your doctor may recommend that||
9131|064|P|you receive a smaller test dose before starting your regular||
9131|065|P|dose. This product may contain inactive ingredients, which can||
9131|066|P|cause allergic reactions or other problems. Talk to your||
9131|067|P|pharmacist for more details.||
9131|068|P|   Before using this medication, tell your doctor or pharmacist||
9131|069|P|your medical history.||
9131|070|P|   This product may contain aluminum, which can rarely build up||
9131|071|P|to dangerous levels in the body. The risk may be increased if||
9131|072|P|this product is used for an extended time, especially in people||
9131|073|P|with kidney disease. Tell your doctor right away if you notice||
9131|074|P|any symptoms of too much aluminum in the body such as muscle||
9131|075|P|weakness, bone pain, or mental changes.||
9131|076|P|   Before having surgery, tell your doctor or dentist about all||
9131|077|P|the products you use (including prescription drugs,||
9131|078|P|nonprescription drugs, and herbal products).||
9131|079|P|   This medication has not been shown to increase risk to an||
9131|080|P|unborn baby when given during pregnancy. Although this medication||
9131|081|P|is unlikely to harm an unborn baby, tell your doctor if you are||
9131|082|P|pregnant before using this medication.||
9131|083|P|   It is unknown if this medication passes into breast milk.||
9131|084|P|Consult your doctor before breastfeeding.||
9131|085|B|||
9131|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9131|087|I|medications work or increase your risk for serious side effects.||
9131|088|I|This document does not contain all possible drug interactions.||
9131|089|I|Keep a list of all the products you use (including||
9131|090|I|prescription/nonprescription drugs and herbal products) and share||
9131|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
9131|092|I|the dosage of any medicines without your doctor's approval.||
9131|093|I|   This medication may interfere with certain lab tests (such as||
9131|094|I|uric acid), possibly causing false test results. Make sure lab||
9131|095|I|personnel and all your doctors know you use this drug.||
9131|096|B|||
9131|097|O|OVERDOSE:  Overdose with this medication is unlikely. However, if||
9131|098|O|someone has overdosed and has serious symptoms such as passing||
9131|099|O|out or trouble breathing, call 911. Otherwise, call a poison||
9131|100|O|control center right away. US residents can call 1-800-222-1222.||
9131|101|O|Canada residents can call 1-844-764-7669.||
9131|102|B|||
9131|103|N|NOTES:  Do not share this medication with others.||
9131|104|N|   This product is not a substitute for a proper diet. Remember||
9131|105|N|that it is best to get your vitamins from healthy foods. Thiamine||
9131|106|N|is commonly found in foods such as enriched bread/cereal/pasta,||
9131|107|N|whole grains (especially wheat germ), lean meats (especially||
9131|108|N|pork), fish, dried beans, peas, and soybeans.||
9131|109|B|||
9131|110|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9131|111|D|If it is near the time of the next dose, skip the missed dose.||
9131|112|D|Use your next dose at the regular time. Do not double the dose to||
9131|113|D|catch up.||
9131|114|B|||
9131|115|R|STORAGE:  Store at room temperature away from light. Do not||
9131|116|R|freeze. Consult your product instructions or pharmacist on when||
9131|117|R|to discard opened containers. Keep all medications away from||
9131|118|R|children and pets.||
9131|119|R|   Do not flush medications down the toilet or pour them into a||
9131|120|R|drain unless instructed to do so. Properly discard this product||
9131|121|R|when it is expired or no longer needed. Consult your pharmacist||
9131|122|R|or local waste disposal company.||
9131|123|B|||
9131|124|A|Information last revised November 2024.||
9131|125|A|Copyright(c) 2025 First Databank, Inc.||
9131|126|B|||
9132|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9132|002|Z|does NOT have all possible information about this product. This||
9132|003|Z|information does not assure that this product is safe, effective,||
9132|004|Z|or appropriate for you. This information is not individual||
9132|005|Z|medical advice and does not substitute for the advice of your||
9132|006|Z|health care professional. Always ask your health care||
9132|007|Z|professional for complete information about this product and your||
9132|008|Z|specific health needs.||
9132|009|B|||
9132|010|T|ONDANSETRON - INJECTION||
9132|011|F|(on-DANS-eh-tron)||
9132|012|B|||
9132|013|C|COMMON BRAND NAME(S): Zofran||
9132|014|B|||
9132|015|U|USES:  This medication is used alone or with other medications to||
9132|016|U|prevent nausea and vomiting caused by cancer chemotherapy. It is||
9132|017|U|also used to prevent and treat nausea and vomiting after surgery.||
9132|018|U|It works by blocking one of the body's natural substances||
9132|019|U|(serotonin) that causes vomiting.||
9132|020|B|||
9132|021|H|HOW TO USE:  To prevent nausea from chemotherapy, ondansetron is||
9132|022|H|given by injection into a vein as directed by your doctor,||
9132|023|H|usually over 15 minutes. This drug is usually started 30 minutes||
9132|024|H|before your chemotherapy treatment begins. Do not give this||
9132|025|H|medication any faster than recommended or take more than the||
9132|026|H|recommended dose because this may increase the chance of serious||
9132|027|H|side effects such as blurred vision or slowed/irregular||
9132|028|H|heartbeat. The usual maximum single dose is 16 milligrams. Older||
9132|029|H|adults are usually prescribed a lower dose to decrease the risk||
9132|030|H|of side effects. Depending on the type of chemotherapy treatment||
9132|031|H|you are receiving, a second and third dose may be given 4 and 8||
9132|032|H|hours after your first dose. You may also be switched to a||
9132|033|H|medication you can take by mouth.||
9132|034|H|   Your doctor may direct you to continue this medication for 1||
9132|035|H|or 2 days after your chemotherapy treatment. If you are using||
9132|036|H|this medication on a prescribed schedule, use it regularly to get||
9132|037|H|the most benefit from it. To help you remember, use it at the||
9132|038|H|same times each day. Use this medication exactly as directed. Do||
9132|039|H|not use more medication or use it more often than prescribed. Ask||
9132|040|H|your doctor or pharmacist if you have questions.||
9132|041|H|   If you are using this medication at home, learn all||
9132|042|H|preparation and usage instructions from your health care||
9132|043|H|professional. Vials may sometimes have particles near the top of||
9132|044|H|the vial. If particles are present, shake the vial to try to||
9132|045|H|dissolve the particles. Before using, check this product for||
9132|046|H|particles or discoloration. If either is present, do not use the||
9132|047|H|liquid. Learn how to store and discard medical supplies safely.||
9132|048|H|   To prevent or treat nausea after surgery, a single dose of||
9132|049|H|ondansetron is given by injection into a muscle or into a vein||
9132|050|H|shortly before the start of surgery, during surgery, or after||
9132|051|H|surgery by a health care professional.||
9132|052|H|   The dosage is based on your weight, medical condition, age,||
9132|053|H|and response to treatment.||
9132|054|H|   Tell your doctor if your condition does not get better or if||
9132|055|H|it gets worse.||
9132|056|B|||
9132|057|S|SIDE EFFECTS:  Headache, fever, lightheadedness, dizziness,||
9132|058|S|drowsiness, tiredness, constipation, or redness/pain/burning at||
9132|059|S|the injection site may occur. If these effects last or get worse,||
9132|060|S|tell your doctor promptly.||
9132|061|S|   Remember that this medication has been prescribed because your||
9132|062|S|doctor has judged that the benefit to you is greater than the||
9132|063|S|risk of side effects. Many people using this medication do not||
9132|064|S|have serious side effects.||
9132|065|S|   Tell your doctor right away if you have any serious side||
9132|066|S|effects, including: stomach pain, muscle stiffness/spasm, vision||
9132|067|S|changes (such as temporary loss of vision, blurred vision,||
9132|068|S|uncontrollable eye movements).||
9132|069|S|   Get medical help right away if you have any very serious side||
9132|070|S|effects, including: chest pain, slow/fast/irregular heartbeat,||
9132|071|S|severe dizziness, fainting.||
9132|072|S|   This medication may increase serotonin and rarely cause a very||
9132|073|S|serious condition called serotonin syndrome/toxicity. The risk||
9132|074|S|increases if you are also taking other drugs that increase||
9132|075|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
9132|076|S|take (see Drug Interactions section). Get medical help right away||
9132|077|S|if you develop some of the following symptoms: fast heartbeat,||
9132|078|S|hallucinations, loss of coordination, severe dizziness, severe||
9132|079|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
9132|080|S|unusual agitation/restlessness.||
9132|081|S|   A very serious allergic reaction to this drug is rare.||
9132|082|S|However, get medical help right away if you notice any symptoms||
9132|083|S|of a serious allergic reaction, including: rash, itching/swelling||
9132|084|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9132|085|S|breathing.||
9132|086|S|   This is not a complete list of possible side effects. If you||
9132|087|S|notice other effects not listed above, contact your doctor or||
9132|088|S|pharmacist.||
9132|089|S|   In the US -||
9132|090|S|   Call your doctor for medical advice about side effects. You||
9132|091|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9132|092|S|www.fda.gov/medwatch.||
9132|093|S|   In Canada - Call your doctor for medical advice about side||
9132|094|S|effects. You may report side effects to Health Canada at||
9132|095|S|1-866-234-2345.||
9132|096|B|||
9132|097|P|PRECAUTIONS:  Before using ondansetron, tell your doctor or||
9132|098|P|pharmacist if you are allergic to it; or to other serotonin||
9132|099|P|blockers (such as granisetron); or if you have any other||
9132|100|P|allergies. This product may contain inactive ingredients, which||
9132|101|P|can cause allergic reactions or other problems. Talk to your||
9132|102|P|pharmacist for more details.||
9132|103|P|   Before using this medication, tell your doctor or pharmacist||
9132|104|P|your medical history, especially of: irregular heartbeat, liver||
9132|105|P|disease, stomach/intestinal problems (such as recent abdominal||
9132|106|P|surgery, ileus, swelling).||
9132|107|P|   Ondansetron may cause a condition that affects the heart||
9132|108|P|rhythm (QT prolongation). QT prolongation can rarely cause||
9132|109|P|serious (rarely fatal) fast/irregular heartbeat and other||
9132|110|P|symptoms (such as severe dizziness, fainting) that need medical||
9132|111|P|attention right away.||
9132|112|P|   The risk of QT prolongation may be increased if you have||
9132|113|P|certain medical conditions or are taking other drugs that may||
9132|114|P|cause QT prolongation. Before using ondansetron, tell your doctor||
9132|115|P|or pharmacist of all the drugs you take and if you have any of||
9132|116|P|the following conditions: certain heart problems (heart failure,||
9132|117|P|slow heartbeat, QT prolongation in the EKG), family history of||
9132|118|P|certain heart problems (QT prolongation in the EKG, sudden||
9132|119|P|cardiac death).||
9132|120|P|   Low levels of potassium or magnesium in the blood may also||
9132|121|P|increase your risk of QT prolongation. This risk may increase if||
9132|122|P|you use certain drugs (such as diuretics/"water pills") or if you||
9132|123|P|have conditions such as severe sweating, diarrhea, or vomiting.||
9132|124|P|Talk to your doctor about using ondansetron safely.||
9132|125|P|   This drug may make you dizzy or drowsy or blur your vision.||
9132|126|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9132|127|P|drowsy. Do not drive, use machinery, or do anything that needs||
9132|128|P|alertness or clear vision until you can do it safely. Limit||
9132|129|P|alcoholic beverages. Talk to your doctor if you are using||
9132|130|P|marijuana (cannabis).||
9132|131|P|   Infants younger than 5 months may be more sensitive to the||
9132|132|P|effects of this drug, especially diarrhea.||
9132|133|P|   Older adults may be more sensitive to the side effects of this||
9132|134|P|drug, especially QT prolongation (see also How To Use section).||
9132|135|P|   During pregnancy, this medication should be used only when||
9132|136|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
9132|137|P|benefits with your doctor.||
9132|138|P|   This medication passes into breast milk. Consult your doctor||
9132|139|P|before breastfeeding.||
9132|140|B|||
9132|141|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9132|142|I|medications work or increase your risk for serious side effects.||
9132|143|I|This document does not contain all possible drug interactions.||
9132|144|I|Keep a list of all the products you use (including||
9132|145|I|prescription/nonprescription drugs and herbal products) and share||
9132|146|I|it with your doctor and pharmacist. Do not start, stop, or change||
9132|147|I|the dosage of any medicines without your doctor's approval.||
9132|148|I|   Some products that may interact with this drug include:||
9132|149|I|apomorphine, tramadol.||
9132|150|I|   The risk of serotonin syndrome/toxicity increases if you are||
9132|151|I|also taking other drugs that increase serotonin. Examples include||
9132|152|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
9132|153|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
9132|154|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
9132|155|I|serotonin syndrome/toxicity may be more likely when you start or||
9132|156|I|increase the dose of these drugs.||
9132|157|B|||
9132|158|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9132|159|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9132|160|O|poison control center right away. US residents can call||
9132|161|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9132|162|O|Symptoms of overdose may include: change in vision, severe||
9132|163|O|dizziness, irregular heartbeat.||
9132|164|B|||
9132|165|N|NOTES:  Lab and/or medical tests (such as EKG) should be done||
9132|166|N|while you are using this medication. Keep all medical and lab||
9132|167|N|appointments. Consult your doctor for more details.||
9132|168|B|||
9132|169|D|MISSED DOSE:  It is important that the dose be given before||
9132|170|D|cancer chemotherapy as directed. If you miss a dose, ask your||
9132|171|D|doctor or pharmacist for a new dose schedule. If you are using||
9132|172|D|this medication on a regular schedule and you miss a dose, use it||
9132|173|D|as soon as you remember. If it is near the time of the next dose,||
9132|174|D|skip the missed dose. Use your next dose at the regular time. Do||
9132|175|D|not double the dose to catch up.||
9132|176|B|||
9132|177|R|STORAGE:  Consult the product instructions and your pharmacist||
9132|178|R|for storage details. Keep all medications away from children and||
9132|179|R|pets.||
9132|180|R|   Do not flush medications down the toilet or pour them into a||
9132|181|R|drain unless instructed to do so. Properly discard this product||
9132|182|R|when it is expired or no longer needed. Consult your pharmacist||
9132|183|R|or local waste disposal company.||
9132|184|B|||
9132|185|A|Information last revised June 2025.||
9132|186|A|Copyright(c) 2025 First Databank, Inc.||
9132|187|B|||
9133|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9133|002|Z|does NOT have all possible information about this product. This||
9133|003|Z|information does not assure that this product is safe, effective,||
9133|004|Z|or appropriate for you. This information is not individual||
9133|005|Z|medical advice and does not substitute for the advice of your||
9133|006|Z|health care professional. Always ask your health care||
9133|007|Z|professional for complete information about this product and your||
9133|008|Z|specific health needs.||
9133|009|B|||
9133|010|T|PROCARBAZINE - ORAL||
9133|011|F|(proe-KAR-ba-zeen)||
9133|012|B|||
9133|013|C|COMMON BRAND NAME(S): Matulane||
9133|014|B|||
9133|015|U|USES:  This medication is used to treat Hodgkin's disease (also||
9133|016|U|known as Hodgkin's lymphoma). Procarbazine belongs to a class of||
9133|017|U|drugs known as alkylating agents. It works by slowing or stopping||
9133|018|U|the growth of cancer cells.||
9133|019|B|||
9133|020|V|OTHER USES:  This section contains uses of this drug that are not||
9133|021|V|listed in the approved professional labeling for the drug but||
9133|022|V|that may be prescribed by your health care professional. Use this||
9133|023|V|drug for a condition that is listed in this section only if it||
9133|024|V|has been so prescribed by your health care professional.||
9133|025|V|   This drug may also be used for other types of cancer (such as||
9133|026|V|brain tumor).||
9133|027|B|||
9133|028|H|HOW TO USE:  See also Precautions and Drug Interactions sections.||
9133|029|H|   Read the Patient Information Leaflet if available from your||
9133|030|H|pharmacist before you start taking procarbazine and each time you||
9133|031|H|get a refill. If you have any questions, ask your doctor or||
9133|032|H|pharmacist.||
9133|033|H|   Take this medication as directed by your doctor, usually once||
9133|034|H|or twice daily. It is usually taken for a 2-week period, then||
9133|035|H|stopped for a time and repeated. This is called a treatment||
9133|036|H|cycle. Do not chew or crush the capsules before swallowing. To||
9133|037|H|reduce your risk of side effects, your doctor may direct you to||
9133|038|H|start this medication at a low dose and gradually increase your||
9133|039|H|dose. Follow your doctor's instructions carefully.||
9133|040|H|   The dosage is based on your medical condition, response to||
9133|041|H|treatment, age, body size, and other medications you may be||
9133|042|H|taking. Be sure to tell your doctor and pharmacist about all the||
9133|043|H|products you use (including prescription drugs, nonprescription||
9133|044|H|drugs, and herbal products).||
9133|045|H|   Use this medication regularly to get the most benefit from it.||
9133|046|H|To help you remember, take it at the same time(s) each day.||
9133|047|H|   To prevent a very serious high blood pressure reaction, it is||
9133|048|H|very important that you follow a special diet recommended by your||
9133|049|H|doctor or dietician to limit your intake of tyramine while you||
9133|050|H|are taking this medicine. Avoid foods and beverages that are high||
9133|051|H|in tyramine, including aged cheeses, dried/aged meats and||
9133|052|H|sausages (such as salami, liverwurst), preserved fish (such as||
9133|053|H|pickled herring), products that contain large amounts of yeast||
9133|054|H|(such as bouillon cubes, powdered soup/gravy, homemade or||
9133|055|H|sourdough bread), fermented foods (such as sauerkraut, kim chee),||
9133|056|H|most soybean products (such as soy sauce, tofu), broad/fava||
9133|057|H|beans, red wine, sherry, tap beers, and vermouth. Consult your||
9133|058|H|doctor or dietician for more details and a complete list of other||
9133|059|H|foods that contain tyramine which you should limit or avoid.||
9133|060|H|   Do not stop taking this medication, even if you have nausea.||
9133|061|H|If you vomit soon after taking a dose, contact your doctor right||
9133|062|H|away for instructions.||
9133|063|B|||
9133|064|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, constipation,||
9133|065|S|dry mouth, difficulty swallowing, drowsiness, dizziness,||
9133|066|S|headache, trouble sleeping, muscle/joint pain, or darkening of||
9133|067|S|the skin may occur. Nausea and vomiting can be severe. In some||
9133|068|S|cases, your doctor may prescribe medication to prevent or relieve||
9133|069|S|nausea and vomiting. Eating several small meals, not eating||
9133|070|S|before treatment, or limiting activity may help lessen some of||
9133|071|S|these effects. If any of these effects last or get worse, tell||
9133|072|S|your doctor or pharmacist promptly.||
9133|073|S|   Temporary hair loss may occur. Normal hair growth should||
9133|074|S|return after treatment has ended.||
9133|075|S|   People using this medication may have serious side effects.||
9133|076|S|However, you have been prescribed this drug because your doctor||
9133|077|S|has judged that the benefit to you is greater than the risk of||
9133|078|S|side effects. Careful monitoring by your doctor may decrease your||
9133|079|S|risk.||
9133|080|S|   Tell your doctor right away if you have any serious side||
9133|081|S|effects, including: unusual bleeding/bruising, diarrhea,||
9133|082|S|tingling/numbness of hands/feet, mental/mood changes (such as||
9133|083|S|confusion, depression), mouth/lip sores.||
9133|084|S|   This medication may lower your ability to fight infections.||
9133|085|S|This may make you more likely to get a serious (rarely fatal)||
9133|086|S|infection or make any infection you have worse. Tell your doctor||
9133|087|S|right away if you have any signs of infection (such as sore||
9133|088|S|throat that doesn't go away, fever, chills).||
9133|089|S|   Get medical help right away if you have any very serious side||
9133|090|S|effects, such as: seizure.||
9133|091|S|   This drug may rarely cause an attack of extremely high blood||
9133|092|S|pressure (hypertensive crisis), which may be fatal. Many drug and||
9133|093|S|food interactions can increase this risk (see How to Use and Drug||
9133|094|S|Interactions sections). Get medical help right away if any of||
9133|095|S|these serious side effects occur: severe headache,||
9133|096|S|fast/slow/irregular/pounding heartbeat, chest pain, neck||
9133|097|S|stiffness/soreness, severe nausea/vomiting, sweating/clammy skin||
9133|098|S|(sometimes with fever), widened pupils, vision changes (such as||
9133|099|S|double/blurred vision), sudden sensitivity to light||
9133|100|S|(photophobia).||
9133|101|S|   This medication may increase serotonin and rarely cause a very||
9133|102|S|serious condition called serotonin syndrome/toxicity. The risk||
9133|103|S|increases if you are also taking other drugs that increase||
9133|104|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
9133|105|S|take (see Drug Interactions section). Get medical help right away||
9133|106|S|if you develop some of the following symptoms: fast heartbeat,||
9133|107|S|hallucinations, loss of coordination, severe dizziness, severe||
9133|108|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
9133|109|S|unusual agitation/restlessness.||
9133|110|S|   Very rarely, people with cancer who are treated with this type||
9133|111|S|of medication have developed other cancers (such as leukemia).||
9133|112|S|Your risk is greater if you have had certain types of||
9133|113|S|chemotherapy or radiation treatment. Talk with your doctor for||
9133|114|S|more details.||
9133|115|S|   A very serious allergic reaction to this drug is rare.||
9133|116|S|However, get medical help right away if you notice any symptoms||
9133|117|S|of a serious allergic reaction, such as: rash, itching/swelling||
9133|118|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9133|119|S|breathing.||
9133|120|S|   This is not a complete list of possible side effects. If you||
9133|121|S|notice other effects not listed above, contact your doctor or||
9133|122|S|pharmacist.||
9133|123|S|   In the US -||
9133|124|S|   Call your doctor for medical advice about side effects. You||
9133|125|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9133|126|S|www.fda.gov/medwatch.||
9133|127|S|   In Canada - Call your doctor for medical advice about side||
9133|128|S|effects. You may report side effects to Health Canada at||
9133|129|S|1-866-234-2345.||
9133|130|B|||
9133|131|P|PRECAUTIONS:  Before taking procarbazine, tell your doctor or||
9133|132|P|pharmacist if you are allergic to it; or if you have any other||
9133|133|P|allergies. This product may contain inactive ingredients, which||
9133|134|P|can cause allergic reactions or other problems. Talk to your||
9133|135|P|pharmacist for more details.||
9133|136|P|   Before using this medication, tell your doctor or pharmacist||
9133|137|P|your medical history, especially of: bleeding/blood problems,||
9133|138|P|current/recent/returning infection, kidney disease, liver||
9133|139|P|disease, radiation treatment.||
9133|140|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9133|141|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9133|142|P|machinery, or do anything that needs alertness until you can do||
9133|143|P|it safely. Talk to your doctor if you are using marijuana||
9133|144|P|(cannabis).||
9133|145|P|   Avoid alcoholic drinks and products while taking this||
9133|146|P|medication because severe stomach upset/cramps, nausea, vomiting,||
9133|147|P|headache, and flushing may occur.||
9133|148|P|   Avoid smoking while using this medication. Smoking increases||
9133|149|P|the risk of developing lung cancer while using this drug. Talk to||
9133|150|P|your doctor or pharmacist for more details.||
9133|151|P|   This medication may make you more sensitive to the sun. Limit||
9133|152|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9133|153|P|sunscreen and wear protective clothing when outdoors. Tell your||
9133|154|P|doctor right away if you get sunburned or have skin||
9133|155|P|blisters/redness.||
9133|156|P|   Procarbazine can make you more likely to get infections or may||
9133|157|P|make current infections worse. Stay away from anyone who has an||
9133|158|P|infection that may easily spread (such as chickenpox, COVID-19,||
9133|159|P|measles, flu). Talk to your doctor if you have been exposed to an||
9133|160|P|infection or for more details.||
9133|161|P|   Tell your health care professional that you are using||
9133|162|P|procarbazine before having any immunizations/vaccinations. Avoid||
9133|163|P|contact with people who have recently received live vaccines||
9133|164|P|(such as flu vaccine inhaled through the nose).||
9133|165|P|   To lower the chance of getting cut, bruised, or injured, use||
9133|166|P|caution with sharp objects like razors and nail cutters, and||
9133|167|P|avoid activities such as contact sports.||
9133|168|P|   Before having surgery, tell your doctor or dentist about all||
9133|169|P|the products you use (including prescription drugs,||
9133|170|P|nonprescription drugs, and herbal products).||
9133|171|P|   Children may be more sensitive to the side effects of this||
9133|172|P|drug, especially shaking (tremors), loss of consciousness, or||
9133|173|P|seizures.||
9133|174|P|   Tell your doctor if you are pregnant or plan to become||
9133|175|P|pregnant. You should not become pregnant while using||
9133|176|P|procarbazine. Procarbazine may harm an unborn baby. Ask about||
9133|177|P|reliable forms of birth control while using this medication. If||
9133|178|P|you become pregnant, talk to your doctor right away about the||
9133|179|P|risks and benefits of this medication.||
9133|180|P|   It is unknown if this drug passes into breast milk. Because of||
9133|181|P|the possible risk to the infant, breastfeeding is not recommended||
9133|182|P|while using this drug. Consult your doctor before breastfeeding.||
9133|183|B|||
9133|184|I|DRUG INTERACTIONS:  See also How to Use section.||
9133|185|I|   Drug interactions may change how your medications work or||
9133|186|I|increase your risk for serious side effects. This document does||
9133|187|I|not contain all possible drug interactions. Keep a list of all||
9133|188|I|the products you use (including prescription/nonprescription||
9133|189|I|drugs and herbal products) and share it with your doctor and||
9133|190|I|pharmacist. Do not start, stop, or change the dosage of any||
9133|191|I|medicines without your doctor's approval.||
9133|192|I|   Some products that may interact with this drug are: diet||
9133|193|I|pills/appetite suppressants (such as diethylpropion), drugs for||
9133|194|I|attention deficit hyperactivity-ADHD (such as atomoxetine,||
9133|195|I|methylphenidate), apraclonidine, bupropion, buspirone,||
9133|196|I|carbamazepine, cyclobenzaprine, deutetrabenazine,||
9133|197|I|dextromethorphan, methyldopa, metoclopramide, tetrabenazine,||
9133|198|I|valbenazine, certain opioid medications (such as meperidine,||
9133|199|I|methadone, tapentadol), certain supplements (such as tryptophan,||
9133|200|I|tyramine), certain "triptans" used to treat migraine headaches||
9133|201|I|(such as rizatriptan, sumatriptan), certain drugs for Parkinson's||
9133|202|I|disease (entacapone, levodopa, tolcapone).||
9133|203|I|   The risk of serotonin syndrome/toxicity increases if you are||
9133|204|I|also taking other drugs that increase serotonin. Examples include||
9133|205|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
9133|206|I|antidepressants (including maprotiline, mirtazapine, SSRIs such||
9133|207|I|as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine,||
9133|208|I|tricyclics such as amitriptyline/doxepin), among others. The risk||
9133|209|I|of serotonin syndrome/toxicity may be more likely when you start||
9133|210|I|or increase the dose of these drugs.||
9133|211|I|   Some products can interact with procarbazine if you take them||
9133|212|I|together, or even if you take them weeks before or after taking||
9133|213|I|procarbazine. Tell your doctor or pharmacist if you take anything||
9133|214|I|in the list of products that may interact with this drug, or any||
9133|215|I|of the products that increase serotonin, within 2 weeks before or||
9133|216|I|after taking procarbazine. Also tell them if you have taken||
9133|217|I|fluoxetine within 5 weeks before starting procarbazine. Ask your||
9133|218|I|doctor how much time to wait between starting or stopping any of||
9133|219|I|these drugs and starting procarbazine.||
9133|220|I|   Taking other MAO inhibitors with this medication may cause a||
9133|221|I|serious (possibly fatal) drug interaction. Do not take any other||
9133|222|I|MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene||
9133|223|I|blue, moclobemide, phenelzine, rasagiline, safinamide,||
9133|224|I|selegiline, tranylcypromine) during treatment with this||
9133|225|I|medication. Most MAO inhibitors should also not be taken for two||
9133|226|I|weeks before and after treatment with this medication. Ask your||
9133|227|I|doctor when to start or stop taking this medication.||
9133|228|I|   Before using procarbazine, report the use of drugs that may||
9133|229|I|increase the risk of extremely high blood pressure (hypertensive||
9133|230|I|crisis) when combined with procarbazine, including herbal||
9133|231|I|products (such as ephedra/ma huang), allergy and cough-and-cold||
9133|232|I|products (including dextromethorphan, decongestants such as||
9133|233|I|phenylephrine/pseudoephedrine), and stimulants (such as||
9133|234|I|amphetamines, ephedrine, epinephrine, phenylalanine).||
9133|235|I|Procarbazine should not be used with any of these medications.||
9133|236|I|Talk to your doctor or pharmacist for more details.||
9133|237|I|   Tell your doctor or pharmacist if you are taking other||
9133|238|I|products that cause drowsiness including alcohol, marijuana||
9133|239|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
9133|240|I|drugs for sleep or anxiety (such as alprazolam, diazepam,||
9133|241|I|zolpidem), muscle relaxants (such as carisoprodol,||
9133|242|I|cyclobenzaprine), and opioid pain relievers (such as codeine,||
9133|243|I|hydrocodone).||
9133|244|I|   Check the labels on all your medicines (such as allergy or||
9133|245|I|cough-and-cold products) because they may contain ingredients||
9133|246|I|that cause drowsiness.||
9133|247|B|||
9133|248|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9133|249|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9133|250|O|poison control center right away. US residents can call||
9133|251|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9133|252|B|||
9133|253|N|NOTES:  Do not share this medication with others.||
9133|254|N|   Lab and/or medical tests (such as complete blood counts,||
9133|255|N|kidney/liver/lung function) should be done before you start||
9133|256|N|taking this medication and while you are taking it. Keep all||
9133|257|N|medical and lab appointments.||
9133|258|B|||
9133|259|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9133|260|D|remember. If it is near the time of the next dose, skip the||
9133|261|D|missed dose. Take your next dose at the regular time. Do not||
9133|262|D|double the dose to catch up.||
9133|263|B|||
9133|264|R|STORAGE:  Store at room temperature away from light and moisture.||
9133|265|R|Do not store in the bathroom. Keep all medications away from||
9133|266|R|children and pets.||
9133|267|R|   Do not flush medications down the toilet or pour them into a||
9133|268|R|drain unless instructed to do so. Properly discard this product||
9133|269|R|when it is expired or no longer needed. Consult your pharmacist||
9133|270|R|or local waste disposal company.||
9133|271|B|||
9133|272|M|MEDICAL ALERT:  Your condition can cause complications in a||
9133|273|M|medical emergency. For information about enrolling in MedicAlert,||
9133|274|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9133|275|B|||
9133|276|A|Information last revised July 2025.||
9133|277|A|Copyright(c) 2025 First Databank, Inc.||
9133|278|B|||
9134|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9134|002|Z|does NOT have all possible information about this product. This||
9134|003|Z|information does not assure that this product is safe, effective,||
9134|004|Z|or appropriate for you. This information is not individual||
9134|005|Z|medical advice and does not substitute for the advice of your||
9134|006|Z|health care professional. Always ask your health care||
9134|007|Z|professional for complete information about this product and your||
9134|008|Z|specific health needs.||
9134|009|B|||
9134|010|T|DACTINOMYCIN - INJECTION||
9134|011|F|(dack-tin-oh-MY-sin)||
9134|012|B|||
9134|013|C|COMMON BRAND NAME(S): Cosmegen||
9134|014|B|||
9134|015|U|USES:  Dactinomycin is used to treat cancer. It works by slowing||
9134|016|U|or stopping the growth of cancer cells.||
9134|017|B|||
9134|018|H|HOW TO USE:  This medication is given by injection into a vein||
9134|019|H|over 10 to 15 minutes by a health care professional as directed||
9134|020|H|by your doctor, usually once daily for 1 to 5 days. If this||
9134|021|H|medication accidentally leaks into surrounding tissue when being||
9134|022|H|given, the skin and/or muscle may be severely damaged. Tell your||
9134|023|H|doctor or nurse right away if you have pain, burning, redness,||
9134|024|H|blistering, or irritation at the injection site.||
9134|025|H|   Dosage is based on your medical condition, weight, body size,||
9134|026|H|and response to treatment. Your doctor will order lab tests to||
9134|027|H|make sure you can receive your next dose. Keep all medical/lab||
9134|028|H|appointments.||
9134|029|H|   Since this drug can be absorbed through the skin and lungs,||
9134|030|H|women who are pregnant or who may become pregnant should not||
9134|031|H|handle this medication or breathe the dust from the powder.||
9134|032|B|||
9134|033|S|SIDE EFFECTS:  See also How to Use section.||
9134|034|S|   Nausea, vomiting, or diarrhea may occur. Nausea and vomiting||
9134|035|S|can be severe. In some cases, your doctor may prescribe||
9134|036|S|medication to prevent or relieve nausea and vomiting. Eating||
9134|037|S|several small meals, not eating before treatment, or limiting||
9134|038|S|activity may help lessen some of these effects. If these effects||
9134|039|S|last or get worse, tell your doctor or pharmacist promptly.||
9134|040|S|   Temporary hair loss is another common side effect. Normal hair||
9134|041|S|growth should return after treatment has ended.||
9134|042|S|   Many people using this medication may have serious side||
9134|043|S|effects. However, you have been prescribed this drug because your||
9134|044|S|doctor has judged that the benefit to you is greater than the||
9134|045|S|risk of side effects. Careful monitoring by your doctor may||
9134|046|S|decrease your risk. Serious side effects may not happen until||
9134|047|S|days to weeks after your treatment.||
9134|048|S|   Pain/sores in the mouth and throat may occur. Brush your teeth||
9134|049|S|gently/carefully, avoid using mouthwash that contains alcohol,||
9134|050|S|and rinse your mouth often with cool water mixed with baking soda||
9134|051|S|or salt. It may also be best to eat soft, moist foods. Tell your||
9134|052|S|doctor right away if these effects last or get worse or if you||
9134|053|S|have trouble swallowing.||
9134|054|S|   Tell your doctor right away if you have any serious side||
9134|055|S|effects, including: unusual weight gain, signs of liver problems||
9134|056|S|(nausea/vomiting that doesn't stop, loss of appetite,||
9134|057|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), signs||
9134|058|S|of kidney problems (such as change in the amount of urine,||
9134|059|S|painful/difficult urination, red/pinkish urine).||
9134|060|S|   This medication decreases bone marrow function, an effect that||
9134|061|S|may lead to a low number of blood cells such as red cells, white||
9134|062|S|cells, and platelets. This effect can cause anemia, decrease your||
9134|063|S|body's ability to fight an infection, or cause easy||
9134|064|S|bruising/bleeding. Tell your doctor right away if you develop any||
9134|065|S|of the following unlikely symptoms: unusual tiredness, pale skin,||
9134|066|S|signs of infection (such as sore throat that doesn't go away,||
9134|067|S|fever, chills), easy bruising/bleeding.||
9134|068|S|   Dactinomycin may increase the risk of other cancers (such as||
9134|069|S|leukemia). Consult your doctor for more details.||
9134|070|S|   When dactinomycin is given after radiation treatment, it can||
9134|071|S|sometimes cause a serious skin reaction that looks likes a severe||
9134|072|S|sunburn (radiation recall). The reaction usually develops within||
9134|073|S|days to months after treatment on the skin area previously||
9134|074|S|treated with radiation. Throat problems can also be part of||
9134|075|S|radiation recall with dactinomycin. Tell your doctor right away||
9134|076|S|if you develop skin redness/tenderness/swelling/peeling/blisters||
9134|077|S|or painful/difficult swallowing. If you develop a skin reaction,||
9134|078|S|avoid prolonged sun exposure, tanning booths, and sunlamps. Use a||
9134|079|S|sunscreen and wear protective clothing when outdoors.||
9134|080|S|   A very serious allergic reaction to this drug is rare.||
9134|081|S|However, get medical help right away if you notice any symptoms||
9134|082|S|of a serious allergic reaction, including: rash, itching/swelling||
9134|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9134|084|S|breathing.||
9134|085|S|   This is not a complete list of possible side effects. If you||
9134|086|S|notice other effects not listed above, contact your doctor or||
9134|087|S|pharmacist.||
9134|088|S|   In the US -||
9134|089|S|   Call your doctor for medical advice about side effects. You||
9134|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9134|091|S|www.fda.gov/medwatch.||
9134|092|S|   In Canada - Call your doctor for medical advice about side||
9134|093|S|effects. You may report side effects to Health Canada at||
9134|094|S|1-866-234-2345.||
9134|095|B|||
9134|096|P|PRECAUTIONS:  Before using dactinomycin, tell your doctor or||
9134|097|P|pharmacist if you are allergic to it; or if you have any other||
9134|098|P|allergies. This product may contain inactive ingredients, which||
9134|099|P|can cause allergic reactions or other problems. Talk to your||
9134|100|P|pharmacist for more details.||
9134|101|P|   Before using this medication, tell your doctor or pharmacist||
9134|102|P|your medical history, especially of: current/recent infection||
9134|103|P|(such as herpes, chickenpox), liver problems, kidney problems,||
9134|104|P|blood disorders (such as anemia, clotting problems), previous||
9134|105|P|chemotherapy/radiation treatment.||
9134|106|P|   Do not have immunizations/vaccinations without the consent of||
9134|107|P|your doctor, and avoid contact with people who have recently||
9134|108|P|received oral polio vaccine or flu vaccine inhaled through the||
9134|109|P|nose.||
9134|110|P|   Dactinomycin can make you more likely to get infections or may||
9134|111|P|make current infections worse. Stay away from anyone who has an||
9134|112|P|infection that may easily spread (such as chickenpox, COVID-19,||
9134|113|P|measles, flu). Talk to your doctor if you have been exposed to an||
9134|114|P|infection or for more details.||
9134|115|P|   To lower your chance of getting cut, bruised, or injured, use||
9134|116|P|caution with sharp objects like razors and nail cutters, and||
9134|117|P|avoid activities such as contact sports.||
9134|118|P|   Before having surgery, tell your doctor or dentist about all||
9134|119|P|the products you use (including prescription drugs,||
9134|120|P|nonprescription drugs, and herbal products).||
9134|121|P|   Tell your doctor if you are pregnant or plan to become||
9134|122|P|pregnant. You should not become pregnant while using||
9134|123|P|dactinomycin. Dactinomycin may harm an unborn baby. Women using||
9134|124|P|this medication should ask about reliable forms of birth control||
9134|125|P|during treatment and for 6 months after the last dose. Men using||
9134|126|P|this medication should ask about reliable forms of birth control||
9134|127|P|during treatment and for 3 months after the last dose. If you or||
9134|128|P|your partner becomes pregnant, talk to your doctor right away||
9134|129|P|about the risks and benefits of this medication.||
9134|130|P|   It is unknown if this medication passes into breast milk.||
9134|131|P|Because of the possible risk to the infant, breastfeeding is not||
9134|132|P|recommended while using this medication and for 14 days after the||
9134|133|P|last dose. Consult your doctor before breastfeeding.||
9134|134|B|||
9134|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9134|136|I|medications work or increase your risk for serious side effects.||
9134|137|I|This document does not contain all possible drug interactions.||
9134|138|I|Keep a list of all the products you use (including||
9134|139|I|prescription/nonprescription drugs and herbal products) and share||
9134|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
9134|141|I|the dosage of any medicines without your doctor's approval.||
9134|142|I|   This medication may interfere with certain lab tests (such as||
9134|143|I|antibiotic drug levels), possibly causing false test results.||
9134|144|I|Make sure lab personnel and all your doctors know you use this||
9134|145|I|drug.||
9134|146|B|||
9134|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9134|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9134|149|O|poison control center right away. US residents can call||
9134|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9134|151|B|||
9134|152|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
9134|153|N|liver/kidney function) should be done while you are using this||
9134|154|N|medication. Keep all medical and lab appointments. Consult your||
9134|155|N|doctor for more details.||
9134|156|B|||
9134|157|D|MISSED DOSE:  It is important to get each dose of this medication||
9134|158|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9134|159|D|right away for a new dosing schedule.||
9134|160|B|||
9134|161|R|STORAGE:  Not applicable. This medication is given in a clinic||
9134|162|R|and will not be stored at home.||
9134|163|B|||
9134|164|M|MEDICAL ALERT:  Your condition can cause complications in a||
9134|165|M|medical emergency. For information about enrolling in MedicAlert,||
9134|166|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9134|167|B|||
9134|168|A|Information last revised May 2024.||
9134|169|A|Copyright(c) 2025 First Databank, Inc.||
9134|170|B|||
9135|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9135|002|Z|does NOT have all possible information about this product. This||
9135|003|Z|information does not assure that this product is safe, effective,||
9135|004|Z|or appropriate for you. This information is not individual||
9135|005|Z|medical advice and does not substitute for the advice of your||
9135|006|Z|health care professional. Always ask your health care||
9135|007|Z|professional for complete information about this product and your||
9135|008|Z|specific health needs.||
9135|009|B|||
9135|010|T|CHLORAMBUCIL - ORAL||
9135|011|F|(klor-AM-bue-sil)||
9135|012|B|||
9135|013|C|COMMON BRAND NAME(S): Leukeran||
9135|014|B|||
9135|015|W|WARNING:  Although chlorambucil is used to treat cancer, it may||
9135|016|W|rarely increase your risk of developing other cancers. Also,||
9135|017|W|chlorambucil may lower your ability to fight infections. This may||
9135|018|W|make you more likely to get a serious (rarely fatal) infection or||
9135|019|W|make any infection you have worse. Tell your doctor right away if||
9135|020|W|you develop unusual growths or lumps, swollen lymph nodes, signs||
9135|021|W|of infection (such as sore throat that doesn't go away, fever,||
9135|022|W|chills), easy bruising/bleeding, or unusual tiredness.||
9135|023|W|   Taking chlorambucil during pregnancy may increase the risk of||
9135|024|W|birth defects. Also, it may make it harder for men or women to||
9135|025|W|have a child (decreased fertility) after treatment.||
9135|026|W|   Talk with your doctor about the risks and benefits of||
9135|027|W|treatment with this medication.||
9135|028|B|||
9135|029|U|USES:  This medication is used to treat certain types of cancer||
9135|030|U|(such as leukemia, lymphoma). Chlorambucil belongs to a class of||
9135|031|U|drugs known as alkylating agents. It works by slowing or stopping||
9135|032|U|the growth of cancer cells.||
9135|033|B|||
9135|034|V|OTHER USES:  This section contains uses of this drug that are not||
9135|035|V|listed in the approved professional labeling for the drug but||
9135|036|V|that may be prescribed by your health care professional. Use this||
9135|037|V|drug for a condition that is listed in this section only if it||
9135|038|V|has been so prescribed by your health care professional.||
9135|039|V|   This drug may also be used for certain blood disorders or||
9135|040|V|certain types of kidney disease.||
9135|041|B|||
9135|042|H|HOW TO USE:  Take this medication by mouth as directed by your||
9135|043|H|doctor, usually once daily. Unless otherwise directed by your||
9135|044|H|doctor, drink plenty of fluids to help prevent side effects.||
9135|045|H|   The dosage is based on your medical condition, weight, and||
9135|046|H|response to treatment. Do not increase your dose or take this||
9135|047|H|medication more often than directed. Your condition will not||
9135|048|H|improve any faster and your risk of side effects will increase.||
9135|049|H|   Since this drug can be absorbed through the skin and lungs and||
9135|050|H|may harm an unborn baby, women who are pregnant or who may become||
9135|051|H|pregnant should not handle this medication or breathe the dust||
9135|052|H|from the tablets.||
9135|053|B|||
9135|054|S|SIDE EFFECTS:  See also Warning section.||
9135|055|S|   Rarely, nausea, vomiting, stomach upset, or diarrhea may||
9135|056|S|occur. In some cases, your doctor may prescribe medication to||
9135|057|S|prevent or relieve nausea and vomiting. Eating several small||
9135|058|S|meals, not eating before treatment, or limiting activity may help||
9135|059|S|lessen some of these effects. If any of these effects last or get||
9135|060|S|worse, tell your doctor or pharmacist promptly.||
9135|061|S|   Remember that this medication has been prescribed because your||
9135|062|S|doctor has judged that the benefit to you is greater than the||
9135|063|S|risk of side effects. Many people using this medication do not||
9135|064|S|have serious side effects.||
9135|065|S|   Tell your doctor right away if you have any serious side||
9135|066|S|effects, such as: easy bleeding/bruising, mouth sores,||
9135|067|S|shaking/tremors, muscle problems (such as twitching, stiffness,||
9135|068|S|weakness), numbness/tingling of the hands or feet, mental/mood||
9135|069|S|changes (such as confusion, hallucinations), signs of liver||
9135|070|S|problems (such as nausea/vomiting that doesn't stop, loss of||
9135|071|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
9135|072|S|urine), stopped menstrual periods (women).||
9135|073|S|   Get medical help right away if you have any very serious side||
9135|074|S|effects, such as: seizures.||
9135|075|S|   A very serious allergic reaction to this drug is rare.||
9135|076|S|However, get medical help right away if you notice any symptoms||
9135|077|S|of a serious allergic reaction, such as: rash, itching/swelling||
9135|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9135|079|S|breathing.||
9135|080|S|   This is not a complete list of possible side effects. If you||
9135|081|S|notice other effects not listed above, contact your doctor or||
9135|082|S|pharmacist.||
9135|083|S|   In the US -||
9135|084|S|   Call your doctor for medical advice about side effects. You||
9135|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9135|086|S|www.fda.gov/medwatch.||
9135|087|S|   In Canada - Call your doctor for medical advice about side||
9135|088|S|effects. You may report side effects to Health Canada at||
9135|089|S|1-866-234-2345.||
9135|090|B|||
9135|091|P|PRECAUTIONS:  Before taking chlorambucil, tell your doctor or||
9135|092|P|pharmacist if you are allergic to it; or to other alkylating||
9135|093|P|agents (such as busulfan, cyclophosphamide); or if you have any||
9135|094|P|other allergies. This product may contain inactive ingredients,||
9135|095|P|which can cause allergic reactions or other problems. Talk to||
9135|096|P|your pharmacist for more details.||
9135|097|P|   Before using this medication, tell your doctor or pharmacist||
9135|098|P|your medical history, especially of: gout, bleeding/blood||
9135|099|P|problems, liver disease.||
9135|100|P|   Chlorambucil can make you more likely to get infections or may||
9135|101|P|make current infections worse. Stay away from anyone who has an||
9135|102|P|infection that may easily spread (such as chickenpox, COVID-19,||
9135|103|P|measles, flu). Talk to your doctor if you have been exposed to an||
9135|104|P|infection or for more details.||
9135|105|P|   Tell your health care professional that you are using||
9135|106|P|chlorambucil before having any immunizations/vaccinations. Avoid||
9135|107|P|contact with people who have recently received live vaccines||
9135|108|P|(such as flu vaccine inhaled through the nose).||
9135|109|P|   To lower the chance of getting cut, bruised, or injured, use||
9135|110|P|caution with sharp objects like razors and nail cutters, and||
9135|111|P|avoid activities such as contact sports.||
9135|112|P|   Before having surgery, tell your doctor or dentist about all||
9135|113|P|the products you use (such as prescription drugs, nonprescription||
9135|114|P|drugs, and herbal products).||
9135|115|P|   Children may be more sensitive to the side effects of this||
9135|116|P|drug, especially infertility later in life or seizures.||
9135|117|P|   Tell your doctor if you are pregnant or plan to become||
9135|118|P|pregnant. You should not become pregnant while using||
9135|119|P|chlorambucil. Chlorambucil may harm an unborn baby. If you become||
9135|120|P|pregnant, talk to your doctor right away about the risks and||
9135|121|P|benefits of this medication.||
9135|122|P|   Since this drug can be absorbed through the skin and lungs and||
9135|123|P|may harm an unborn baby, women who are pregnant or who may become||
9135|124|P|pregnant should not handle this medication or breathe the dust||
9135|125|P|from the tablets.||
9135|126|P|   It is unknown if this drug passes into breast milk. Because of||
9135|127|P|the possible risk to the infant, breastfeeding is not recommended||
9135|128|P|while using this drug. Consult your doctor before breastfeeding.||
9135|129|B|||
9135|130|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9135|131|I|medications work or increase your risk for serious side effects.||
9135|132|I|This document does not contain all possible drug interactions.||
9135|133|I|Keep a list of all the products you use (such as||
9135|134|I|prescription/nonprescription drugs and herbal products) and share||
9135|135|I|it with your doctor and pharmacist. Do not start, stop, or change||
9135|136|I|the dosage of any medicines without your doctor's approval.||
9135|137|B|||
9135|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9135|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9135|140|O|poison control center right away. US residents can call||
9135|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9135|142|O|Symptoms of overdose may include: seizures.||
9135|143|B|||
9135|144|N|NOTES:  Do not share this medication with others.||
9135|145|N|   Lab and/or medical tests (such as complete blood counts, uric||
9135|146|N|acid levels) should be done while you are taking this medication.||
9135|147|N|Keep all medical and lab appointments.||
9135|148|B|||
9135|149|D|MISSED DOSE:  It is important to take each dose of this||
9135|150|D|medication as scheduled. If you miss a dose, ask your doctor or||
9135|151|D|pharmacist right away for a new dosing schedule. Do not double||
9135|152|D|the dose to catch up.||
9135|153|B|||
9135|154|R|STORAGE:  Store in the refrigerator away from light and moisture.||
9135|155|R|Do not freeze. Keep all medications away from children and pets.||
9135|156|R|   Do not flush medications down the toilet or pour them into a||
9135|157|R|drain unless instructed to do so. Properly discard this product||
9135|158|R|when it is expired or no longer needed. Consult your pharmacist||
9135|159|R|or local waste disposal company.||
9135|160|B|||
9135|161|M|MEDICAL ALERT:  Your condition can cause complications in a||
9135|162|M|medical emergency. For information about enrolling in MedicAlert,||
9135|163|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9135|164|B|||
9135|165|A|Information last revised May 2025.||
9135|166|A|Copyright(c) 2025 First Databank, Inc.||
9135|167|B|||
9136|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9136|002|Z|does NOT have all possible information about this product. This||
9136|003|Z|information does not assure that this product is safe, effective,||
9136|004|Z|or appropriate for you. This information is not individual||
9136|005|Z|medical advice and does not substitute for the advice of your||
9136|006|Z|health care professional. Always ask your health care||
9136|007|Z|professional for complete information about this product and your||
9136|008|Z|specific health needs.||
9136|009|B|||
9136|010|T|TAMOXIFEN - ORAL||
9136|011|F|(ta-MOX-ih-fen)||
9136|012|B|||
9136|013|C|COMMON BRAND NAME(S): Nolvadex, Soltamox||
9136|014|B|||
9136|015|W|WARNING:  Tamoxifen has rarely caused very serious (possibly||
9136|016|W|fatal) strokes, blood clots in the lungs/legs, and cancer of the||
9136|017|W|uterus. If you are taking tamoxifen to reduce the risk of breast||
9136|018|W|cancer, or if your cancer is limited to the milk ducts (ductal||
9136|019|W|carcinoma in situ-DCIS), then discuss the benefits and risks of||
9136|020|W|taking this medication with your doctor. However, if you are||
9136|021|W|taking tamoxifen to treat breast cancer, then the benefits of||
9136|022|W|taking tamoxifen are greater than the risks of side effects.||
9136|023|W|   Get medical help right away if you develop symptoms of a||
9136|024|W|stroke or blood clots in the lungs/legs, such as weakness on one||
9136|025|W|side of the body, trouble speaking, sudden vision changes,||
9136|026|W|confusion, shortness of breath, chest pain, or calf||
9136|027|W|pain/swelling.||
9136|028|W|   Tell your doctor right away if you develop symptoms of cancer||
9136|029|W|of the uterus, such as unusual changes in your monthly period||
9136|030|W|(such as the amount or timing of bleeding), unusual vaginal||
9136|031|W|discharge, or pain/pressure below your "belly button" (navel).||
9136|032|B|||
9136|033|U|USES:  Tamoxifen is used to treat breast cancer. It is also used||
9136|034|U|to reduce the chances of breast cancer in high-risk patients.||
9136|035|U|   This medication can block the growth of breast cancer. It||
9136|036|U|works by interfering with the effects of estrogen in the breast||
9136|037|U|tissue.||
9136|038|B|||
9136|039|H|HOW TO USE:  Read the Medication Guide provided by your||
9136|040|H|pharmacist before you start using tamoxifen and each time you get||
9136|041|H|a refill. If you have any questions, consult your doctor or||
9136|042|H|pharmacist.||
9136|043|H|   Take this medication by mouth with or without food as directed||
9136|044|H|by your doctor, usually once or twice daily for 5 years. Daily||
9136|045|H|dosages greater than 20 milligrams are usually divided in half||
9136|046|H|and taken twice a day, in the morning and evening, or as directed||
9136|047|H|by your doctor. If you are using the liquid, measure the dose||
9136|048|H|carefully using a special measuring device/spoon. Do not use a||
9136|049|H|household spoon because you may not get the correct dose.||
9136|050|H|   Dosage is based on your medical condition and response to||
9136|051|H|treatment. The duration of treatment to prevent cancer from||
9136|052|H|returning may be between 5 to 10 years, depending on your medical||
9136|053|H|condition and response to treatment.||
9136|054|H|   Use this medication regularly to get the most benefit from it.||
9136|055|H|To help you remember, take it at the same time(s) each day.||
9136|056|H|   If you have breast cancer that has spread to other parts of||
9136|057|H|the body, you may experience increased bone/cancer pain and/or||
9136|058|H|disease flare-up as you start taking tamoxifen. In some cases,||
9136|059|H|this may be a sign of a good response to the medication. Symptoms||
9136|060|H|include increased bone pain, increased tumor size, or even new||
9136|061|H|tumors. These symptoms usually disappear quickly. Always tell||
9136|062|H|your doctor right away about these symptoms.||
9136|063|H|   Since this drug can be absorbed through the skin and lungs,||
9136|064|H|women who are pregnant or who may become pregnant should not||
9136|065|H|handle this medication or breathe the dust from the tablets. (See||
9136|066|H|also Precautions section.)||
9136|067|H|   Tell your doctor right away if your condition gets worse (such||
9136|068|H|as you get new breast lumps).||
9136|069|B|||
9136|070|S|SIDE EFFECTS:  See also Warning section.||
9136|071|S|   Hot flashes, nausea, leg cramps, muscle aches, hair thinning,||
9136|072|S|headache, and numb/tingling skin may occur. A loss of sexual||
9136|073|S|ability/interest may occur in men. If these effects last or get||
9136|074|S|worse, tell your doctor promptly.||
9136|075|S|   Remember that this medication has been prescribed because your||
9136|076|S|doctor has judged that the benefit to you is greater than the||
9136|077|S|risk of side effects. Many people using this medication do not||
9136|078|S|have serious side effects.||
9136|079|S|   Tell your doctor right away if you have any serious side||
9136|080|S|effects, including: vision changes (such as blurred vision), eye||
9136|081|S|pain, easy bruising/bleeding, mental/mood changes, swelling of||
9136|082|S|ankles/feet, unusual tiredness, signs of infection (such as sore||
9136|083|S|throat that doesn't go away, fever, chills), signs of liver||
9136|084|S|disease (such as nausea/vomiting that doesn't stop, loss of||
9136|085|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
9136|086|S|urine).||
9136|087|S|   A very serious allergic reaction to this drug is rare.||
9136|088|S|However, get medical help right away if you notice any symptoms||
9136|089|S|of a serious allergic reaction, including: rash, itching/swelling||
9136|090|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9136|091|S|breathing.||
9136|092|S|   This is not a complete list of possible side effects. If you||
9136|093|S|notice other effects not listed above, contact your doctor or||
9136|094|S|pharmacist.||
9136|095|S|   In the US -||
9136|096|S|   Call your doctor for medical advice about side effects. You||
9136|097|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9136|098|S|www.fda.gov/medwatch.||
9136|099|S|   In Canada - Call your doctor for medical advice about side||
9136|100|S|effects. You may report side effects to Health Canada at||
9136|101|S|1-866-234-2345.||
9136|102|B|||
9136|103|P|PRECAUTIONS:  Before taking tamoxifen, tell your doctor or||
9136|104|P|pharmacist if you are allergic to it; or if you have any other||
9136|105|P|allergies. This product may contain inactive ingredients, which||
9136|106|P|can cause allergic reactions or other problems. Talk to your||
9136|107|P|pharmacist for more details.||
9136|108|P|   Before using this medication, tell your doctor or pharmacist||
9136|109|P|your medical history, especially of: blood clots (such as deep||
9136|110|P|vein thrombosis, pulmonary embolism, stroke), certain heart||
9136|111|P|problems (fast/slow/irregular heartbeat, QT prolongation in the||
9136|112|P|EKG), high cholesterol/triglycerides, limited or no ability to||
9136|113|P|walk (immobility), diabetes, high blood pressure, smoking,||
9136|114|P|cataracts, liver disease.||
9136|115|P|   Before having surgery (especially breast reconstruction), tell||
9136|116|P|your doctor or dentist about all the products you use (including||
9136|117|P|prescription drugs, nonprescription drugs, and herbal products).||
9136|118|P|   Tell your doctor if you are pregnant or plan to become||
9136|119|P|pregnant. You should not become pregnant while using tamoxifen.||
9136|120|P|Tamoxifen may harm an unborn baby. Women using this medication||
9136|121|P|should ask about reliable non-hormonal forms of birth control||
9136|122|P|(such as condoms, diaphragms with spermicide) during treatment||
9136|123|P|and for 2 months after the last dose. Men using this medication||
9136|124|P|should ask about reliable forms of birth control during treatment||
9136|125|P|and for 6 months after the last dose. If you or your partner||
9136|126|P|becomes pregnant, talk to your doctor right away about the risks||
9136|127|P|and benefits of this medication.||
9136|128|P|   It is unknown if this medication passes into breast milk.||
9136|129|P|Because of the possible risk to the infant, breastfeeding is not||
9136|130|P|recommended while using this medication and for 3 months after||
9136|131|P|the last dose. Consult your doctor before breastfeeding.||
9136|132|B|||
9136|133|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9136|134|I|medications work or increase your risk for serious side effects.||
9136|135|I|This document does not contain all possible drug interactions.||
9136|136|I|Keep a list of all the products you use (including||
9136|137|I|prescription/nonprescription drugs and herbal products) and share||
9136|138|I|it with your doctor and pharmacist. Do not start, stop, or change||
9136|139|I|the dosage of any medicines without your doctor's approval.||
9136|140|I|   Some products that may interact with this drug are:||
9136|141|I|anastrozole, "blood thinners" (such as warfarin), estrogens,||
9136|142|I|letrozole, hormonal forms of birth control (such as birth control||
9136|143|I|pills, patches, implants), ribociclib.||
9136|144|I|   Other medications can affect the removal of tamoxifen from||
9136|145|I|your body, which may affect how tamoxifen works. Examples include||
9136|146|I|butalbital, cimetidine, mitotane, rifamycins (such as rifampin),||
9136|147|I|secobarbital, SSRI antidepressants (such as fluoxetine,||
9136|148|I|paroxetine), St. John's wort, drugs used to treat seizures (such||
9136|149|I|as carbamazepine, phenobarbital, phenytoin, primidone), among||
9136|150|I|others.||
9136|151|I|   This medication may interfere with certain lab tests (such as||
9136|152|I|thyroid tests), possibly causing false test results. Make sure||
9136|153|I|lab personnel and all your doctors know you use this drug.||
9136|154|B|||
9136|155|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9136|156|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9136|157|O|poison control center right away. US residents can call||
9136|158|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9136|159|O|Symptoms of overdose may include: shaking, unsteady walking,||
9136|160|O|fainting, or fast/irregular heartbeat.||
9136|161|B|||
9136|162|N|NOTES:  Do not share this medication with others.||
9136|163|N|   Lab and/or medical tests (such as complete blood count,||
9136|164|N|liver/heart function, pelvic exams, mammogram, eye exams) should||
9136|165|N|be done while you are taking this medication. Keep all medical||
9136|166|N|and lab appointments. Consult your doctor for more details.||
9136|167|B|||
9136|168|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9136|169|D|remember. If it is near the time of the next dose, skip the||
9136|170|D|missed dose. Take your next dose at the regular time. Do not||
9136|171|D|double the dose to catch up.||
9136|172|B|||
9136|173|R|STORAGE:  Store at room temperature away from light and moisture.||
9136|174|R|Do not store in the bathroom. If you are using the liquid, do not||
9136|175|R|refrigerate or freeze it. Once the liquid bottle is opened, the||
9136|176|R|medication expires after 3 months. Keep all medications away from||
9136|177|R|children and pets.||
9136|178|R|   Do not flush medications down the toilet or pour them into a||
9136|179|R|drain unless instructed to do so. Properly discard this product||
9136|180|R|when it is expired or no longer needed. Consult your pharmacist||
9136|181|R|or local waste disposal company.||
9136|182|B|||
9136|183|A|Information last revised May 2025.||
9136|184|A|Copyright(c) 2025 First Databank, Inc.||
9136|185|B|||
9137|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9137|002|Z|does NOT have all possible information about this product. This||
9137|003|Z|information does not assure that this product is safe, effective,||
9137|004|Z|or appropriate for you. This information is not individual||
9137|005|Z|medical advice and does not substitute for the advice of your||
9137|006|Z|health care professional. Always ask your health care||
9137|007|Z|professional for complete information about this product and your||
9137|008|Z|specific health needs.||
9137|009|B|||
9137|010|T|VINCRISTINE - INJECTION||
9137|011|F|(vin-CRISS-teen)||
9137|012|B|||
9137|013|C|COMMON BRAND NAME(S): Oncovin||
9137|014|B|||
9137|015|W|WARNING:  This drug is to be given by injection only into a vein.||
9137|016|W|It must not be injected into the spine or into other areas of the||
9137|017|W|body since fatal reactions have occurred.||
9137|018|W|   If vincristine leaks out of the vein into the surrounding||
9137|019|W|area, it may cause serious skin and tissue damage. Tell your||
9137|020|W|health care professional right away if you experience pain,||
9137|021|W|irritation, redness, or swelling at the injection site. Prompt||
9137|022|W|treatment of the leakage will help reduce discomfort and possible||
9137|023|W|skin damage.||
9137|024|W|   Vincristine injection is different than vincristine liposomal||
9137|025|W|injection. The two drugs have different dosage recommendations.||
9137|026|B|||
9137|027|U|USES:  Vincristine is used to treat various types of cancer. It||
9137|028|U|is a cancer chemotherapy drug that is usually used with other||
9137|029|U|chemotherapy drugs to slow or stop cancer cell growth.||
9137|030|B|||
9137|031|H|HOW TO USE:  See also Warning section.||
9137|032|H|   This medication is given by injection only into a vein by a||
9137|033|H|health care professional. It is given on a schedule as directed||
9137|034|H|by your doctor, usually once a week. The dosage is based on your||
9137|035|H|medical condition, body size, and response to treatment.||
9137|036|H|Children's dosage may also be based on weight.||
9137|037|H|   Unless your doctor instructs you otherwise, drink plenty of||
9137|038|H|fluids while using this medication. This helps to reduce some of||
9137|039|H|the side effects to the kidneys.||
9137|040|B|||
9137|041|S|SIDE EFFECTS:  See also Warning section.||
9137|042|S|   Nausea, vomiting, weight loss, diarrhea, mouth sores,||
9137|043|S|dizziness, or headache may occur. If any of these effects last or||
9137|044|S|get worse, tell your doctor or pharmacist promptly.||
9137|045|S|   This medication can also cause constipation, which in some||
9137|046|S|cases may become serious. Consult your doctor or pharmacist about||
9137|047|S|how you can prevent constipation (such as eating a diet high in||
9137|048|S|fiber, drinking enough water). Ask about regularly using a stool||
9137|049|S|softener such as docusate, avoiding bulk-forming laxatives, and||
9137|050|S|choosing a stimulant laxative. Tell your doctor or pharmacist||
9137|051|S|promptly if you develop constipation, stomach/abdominal pain, or||
9137|052|S|bloating.||
9137|053|S|   Temporary hair loss may occur. Normal hair growth should||
9137|054|S|return after treatment has ended.||
9137|055|S|   People using this medication may have serious side effects.||
9137|056|S|However, you have been prescribed this drug because your doctor||
9137|057|S|has judged that the benefit to you is greater than the risk of||
9137|058|S|side effects. Careful monitoring by your doctor may decrease your||
9137|059|S|risk.||
9137|060|S|   This medication may lower your ability to fight infections.||
9137|061|S|This may make you more likely to get a serious (rarely fatal)||
9137|062|S|infection or make any infection you have worse. Tell your doctor||
9137|063|S|right away if you have any signs of infection (such as sore||
9137|064|S|throat that doesn't go away, fever, chills).||
9137|065|S|   This medication commonly affects the nerves and muscles in||
9137|066|S|your body. Most of these side effects go away after this||
9137|067|S|medication is stopped, however some effects may last for a long||
9137|068|S|time. Tell your doctor right away if you have any of the||
9137|069|S|following: painful/difficult urination, decreased urination, pain||
9137|070|S|(including in the joints, back, muscles),||
9137|071|S|numbness/tingling/burning/pain of the feet/hands, weakness,||
9137|072|S|difficulty walking, loss of coordination/balance, inability to||
9137|073|S|move your muscles (including the muscles of your face and other||
9137|074|S|parts of your body), drooping eyelids, hoarseness, trouble||
9137|075|S|speaking.||
9137|076|S|   Tell your doctor right away if you have any serious side||
9137|077|S|effects, including: vision/hearing changes, mental/mood changes||
9137|078|S|(such as depression, hallucinations, confusion), easy||
9137|079|S|bleeding/bruising, severe tiredness.||
9137|080|S|   Get medical help right away if you have any very serious side||
9137|081|S|effects, including: seizures, chest/jaw/left arm pain, signs of||
9137|082|S|liver problems (such as nausea that doesn't stop, dark urine,||
9137|083|S|vomiting, stomach/abdominal pain, yellowing eyes/skin).||
9137|084|S|   Trouble breathing may rarely occur with vincristine treatment,||
9137|085|S|especially when it is given with another chemotherapy drug,||
9137|086|S|mitomycin-C. Patients with lung problems may be more sensitive to||
9137|087|S|this side effect. Long-term treatment of this side effect may be||
9137|088|S|required if it worsens. This effect may occur within minutes to||
9137|089|S|several hours after vincristine is given and up to 2 weeks after||
9137|090|S|the dose of mitomycin-C. Get medical help right away if you have||
9137|091|S|shortness of breath or coughing. If you have this reaction, you||
9137|092|S|should not receive vincristine again.||
9137|093|S|   A very serious allergic reaction to this drug is rare.||
9137|094|S|However, get medical help right away if you notice any symptoms||
9137|095|S|of a serious allergic reaction, including: rash, itching/swelling||
9137|096|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9137|097|S|breathing.||
9137|098|S|   This is not a complete list of possible side effects. If you||
9137|099|S|notice other effects not listed above, contact your doctor or||
9137|100|S|pharmacist.||
9137|101|S|   In the US -||
9137|102|S|   Call your doctor for medical advice about side effects. You||
9137|103|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9137|104|S|www.fda.gov/medwatch.||
9137|105|S|   In Canada - Call your doctor for medical advice about side||
9137|106|S|effects. You may report side effects to Health Canada at||
9137|107|S|1-866-234-2345.||
9137|108|B|||
9137|109|P|PRECAUTIONS:  Before using vincristine, tell your doctor or||
9137|110|P|pharmacist if you are allergic to it or to vincristine liposomal;||
9137|111|P|or if you have any other allergies. This product may contain||
9137|112|P|inactive ingredients, which can cause allergic reactions or other||
9137|113|P|problems. Talk to your pharmacist for more details.||
9137|114|P|   Before using this medication, tell your doctor or pharmacist||
9137|115|P|your medical history, especially of: nerve/muscle problems (such||
9137|116|P|as numbness/tingling/pain due to neuropathy, demyelinating||
9137|117|P|conditions including Charcot-Marie-Tooth syndrome), liver||
9137|118|P|disease, radiation treatment to the liver, decreased bone marrow||
9137|119|P|function, blood disorders, current infection.||
9137|120|P|   This medication can make you more likely to get infections or||
9137|121|P|may make current infections worse. Stay away from anyone who has||
9137|122|P|an infection that may easily spread (such as chickenpox,||
9137|123|P|COVID-19, measles, flu). Talk to your doctor if you have been||
9137|124|P|exposed to an infection or for more details.||
9137|125|P|   Tell your health care professional that you are using||
9137|126|P|vincristine before having any immunizations/vaccinations. Avoid||
9137|127|P|contact with people who have recently received live vaccines||
9137|128|P|(such as flu vaccine inhaled through the nose).||
9137|129|P|   To lower the chance of getting cut, bruised, or injured, use||
9137|130|P|caution with sharp objects like razors and nail cutters, and||
9137|131|P|avoid activities such as contact sports.||
9137|132|P|   This drug may make you dizzy or tired or cause numbness in||
9137|133|P|your hands/feet. Alcohol or marijuana (cannabis) can make you||
9137|134|P|more dizzy or tired. Do not drive, use machinery, or do anything||
9137|135|P|that needs alertness until you can do it safely. Limit alcoholic||
9137|136|P|beverages. Talk to your doctor if you are using marijuana||
9137|137|P|(cannabis).||
9137|138|P|   Before having surgery, tell your doctor or dentist about all||
9137|139|P|the products you use (including prescription drugs,||
9137|140|P|nonprescription drugs, and herbal products).||
9137|141|P|   Children may be more sensitive to the effects of this drug,||
9137|142|P|especially slowed movement of the gut that may cause vomiting and||
9137|143|P|constipation.||
9137|144|P|   This medication may reduce fertility in men and women. Consult||
9137|145|P|your doctor for more details.||
9137|146|P|   Tell your doctor if you are pregnant or plan to become||
9137|147|P|pregnant. You should not become pregnant while using vincristine.||
9137|148|P|Vincristine may harm an unborn baby. Ask about reliable forms of||
9137|149|P|birth control while using this medication. If you become||
9137|150|P|pregnant, talk to your doctor right away about the risks and||
9137|151|P|benefits of this medication.||
9137|152|P|   It is unknown if this drug passes into breast milk. Because of||
9137|153|P|the possible risk to the infant, breastfeeding is not recommended||
9137|154|P|while using this drug. Consult your doctor before breastfeeding.||
9137|155|B|||
9137|156|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9137|157|I|medications work or increase your risk for serious side effects.||
9137|158|I|This document does not contain all possible drug interactions.||
9137|159|I|Keep a list of all the products you use (including||
9137|160|I|prescription/nonprescription drugs and herbal products) and share||
9137|161|I|it with your doctor and pharmacist. Do not start, stop, or change||
9137|162|I|the dosage of any medicines without your doctor's approval.||
9137|163|I|   Some products that may interact with this drug include:||
9137|164|I|digoxin, phenytoin, drugs that may cause nerve damage to the ear||
9137|165|I|(such as chemotherapy drugs that contain platinum).||
9137|166|I|   Other medications can affect the removal of vincristine from||
9137|167|I|your body, which may affect how vincristine works. Examples||
9137|168|I|include azole antifungals (such as itraconazole), macrolide||
9137|169|I|antibiotics (such as erythromycin), rifamycins (such as||
9137|170|I|rifabutin), St. John's wort, drugs used to treat seizures (such||
9137|171|I|as carbamazepine), among others.||
9137|172|B|||
9137|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9137|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9137|175|O|poison control center right away. US residents can call||
9137|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9137|177|B|||
9137|178|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
9137|179|N|uric acid blood levels) should be done while you are using this||
9137|180|N|medication. Keep all medical and lab appointments. Consult your||
9137|181|N|doctor for more details.||
9137|182|B|||
9137|183|D|MISSED DOSE:  It is important to get each dose of this medication||
9137|184|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9137|185|D|right away for a new dosing schedule.||
9137|186|B|||
9137|187|R|STORAGE:  Not applicable. This medication is given in a hospital||
9137|188|R|or clinic or doctor's office and will not be stored at home.||
9137|189|B|||
9137|190|M|MEDICAL ALERT:  Your condition can cause complications in a||
9137|191|M|medical emergency. For information about enrolling in MedicAlert,||
9137|192|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9137|193|B|||
9137|194|A|Information last revised May 2025.||
9137|195|A|Copyright(c) 2025 First Databank, Inc.||
9137|196|B|||
9139|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9139|002|Z|does NOT have all possible information about this product. This||
9139|003|Z|information does not assure that this product is safe, effective,||
9139|004|Z|or appropriate for you. This information is not individual||
9139|005|Z|medical advice and does not substitute for the advice of your||
9139|006|Z|health care professional. Always ask your health care||
9139|007|Z|professional for complete information about this product and your||
9139|008|Z|specific health needs.||
9139|009|B|||
9139|010|T|CALCIUM SUPPLEMENT/VITAMIN D - ORAL||
9139|011|B|||
9139|012|U|USES:  This combination medication is used to prevent or treat||
9139|013|U|low blood calcium levels in people who do not get enough calcium||
9139|014|U|from their diets. It may be used to treat conditions caused by||
9139|015|U|low calcium levels such as bone loss (osteoporosis), weak bones||
9139|016|U|(osteomalacia/rickets), decreased activity of the parathyroid||
9139|017|U|gland (hypoparathyroidism), and a certain muscle disease (latent||
9139|018|U|tetany). It may also be used in certain patients to make sure||
9139|019|U|they are getting enough calcium (including women who are||
9139|020|U|pregnant, nursing, or postmenopausal, people taking certain||
9139|021|U|medications such as phenytoin, phenobarbital, or prednisone).||
9139|022|U|   Calcium plays a very important role in the body. It is||
9139|023|U|necessary for normal functioning of nerves, cells, muscle, and||
9139|024|U|bone. If there is not enough calcium in the blood, then the body||
9139|025|U|will take calcium from bones, thereby weakening bones. Vitamin D||
9139|026|U|helps your body absorb calcium and phosphorus. Having the right||
9139|027|U|amounts of vitamin D, calcium, and phosphorus is important for||
9139|028|U|building and keeping strong bones.||
9139|029|B|||
9139|030|H|HOW TO USE:  Take this medication by mouth with food. If your||
9139|031|H|product contains calcium citrate, then it may be taken with or||
9139|032|H|without food. Follow all directions on the product package, or||
9139|033|H|take as directed by your doctor. For best absorption, if your||
9139|034|H|total daily dose is more than 600 milligrams, then divide your||
9139|035|H|dose and space it throughout the day. If you have any questions,||
9139|036|H|ask your doctor or pharmacist.||
9139|037|H|   If you are using the liquid form of this medication, carefully||
9139|038|H|measure the dose using a special measuring device/spoon. Do not||
9139|039|H|use a household spoon because you may not get the correct dose.||
9139|040|H|   If you are taking the chewable form of this medication, chew||
9139|041|H|thoroughly before swallowing. If you are taking capsules, swallow||
9139|042|H|each capsule whole.||
9139|043|H|   Do not crush or chew extended-release tablets. Doing so can||
9139|044|H|release all of the drug at once, increasing the risk of side||
9139|045|H|effects. Swallow the whole tablet without crushing or chewing.||
9139|046|H|   Use this medication regularly to get the most benefit from it.||
9139|047|H|To help you remember, take it at the same time(s) each day.||
9139|048|H|   If your doctor has recommended that you follow a special diet,||
9139|049|H|it is very important to follow the diet to get the most benefit||
9139|050|H|from this medication and to prevent serious side effects. Do not||
9139|051|H|take other supplements/vitamins unless ordered by your doctor.||
9139|052|H|   Calcium supplements come in different forms that contain||
9139|053|H|different amounts of calcium/vitamin D. Ask your doctor or||
9139|054|H|pharmacist to help select the best product for you.||
9139|055|H|   If you think you may have a serious medical problem, get||
9139|056|H|medical help right away.||
9139|057|B|||
9139|058|S|SIDE EFFECTS:  Constipation or stomach upset may occur. If any of||
9139|059|S|these effects last or get worse, tell your doctor or pharmacist||
9139|060|S|promptly.||
9139|061|S|   If your doctor has directed you to use this medication,||
9139|062|S|remember that your doctor has judged that the benefit to you is||
9139|063|S|greater than the risk of side effects. Many people using this||
9139|064|S|medication do not have serious side effects.||
9139|065|S|   Tell your doctor right away if you have any serious side||
9139|066|S|effects, including: nausea/vomiting, loss of appetite, unusual||
9139|067|S|weight loss, mental/mood changes, signs of kidney problems (such||
9139|068|S|as change in the amount of urine), bone/muscle pain, headache,||
9139|069|S|increased thirst, increased urination, weakness, tiredness,||
9139|070|S|fast/pounding heartbeat.||
9139|071|S|   A very serious allergic reaction to this drug is rare.||
9139|072|S|However, get medical help right away if you notice any symptoms||
9139|073|S|of a serious allergic reaction, including: rash, itching/swelling||
9139|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9139|075|S|breathing.||
9139|076|S|   This is not a complete list of possible side effects. If you||
9139|077|S|notice other effects not listed above, contact your doctor or||
9139|078|S|pharmacist.||
9139|079|S|   In the US -||
9139|080|S|   Call your doctor for medical advice about side effects. You||
9139|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9139|082|S|www.fda.gov/medwatch.||
9139|083|S|   In Canada - Call your doctor for medical advice about side||
9139|084|S|effects. You may report side effects to Health Canada at||
9139|085|S|1-866-234-2345.||
9139|086|B|||
9139|087|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9139|088|P|pharmacist if you are allergic to it; or to other vitamin D||
9139|089|P|products (such as calcitriol); or if you have any other||
9139|090|P|allergies. This product may contain inactive ingredients, which||
9139|091|P|can cause allergic reactions or other problems. Talk to your||
9139|092|P|pharmacist for more details.||
9139|093|P|   Before using this medication, tell your doctor or pharmacist||
9139|094|P|your medical history, especially of: high calcium/vitamin D||
9139|095|P|levels (hypercalcemia/hypervitaminosis D), difficulty absorbing||
9139|096|P|nutrition from food (malabsorption syndrome), heart/blood vessel||
9139|097|P|disease, kidney disease (including kidney stones), certain immune||
9139|098|P|system disorder (sarcoidosis), liver disease, certain bowel||
9139|099|P|diseases (Crohn's disease, Whipple's disease), little or no||
9139|100|P|stomach acid (achlorhydria), low levels of bile, untreated||
9139|101|P|phosphate imbalance.||
9139|102|P|   Chewable tablets may contain sugar or aspartame. Caution is||
9139|103|P|advised if you have diabetes, phenylketonuria (PKU), or any other||
9139|104|P|condition that requires you to limit/avoid these substances in||
9139|105|P|your diet. Ask your doctor or pharmacist about using this product||
9139|106|P|safely.||
9139|107|P|   Before having surgery, tell your doctor or dentist about all||
9139|108|P|the products you use (including prescription drugs,||
9139|109|P|nonprescription drugs, and herbal products).||
9139|110|P|   Tell your doctor if you are pregnant before using this||
9139|111|P|medication. During pregnancy, doses of vitamin D greater than the||
9139|112|P|recommended dietary allowance should be used only when clearly||
9139|113|P|needed. Discuss the risks and benefits with your doctor.||
9139|114|P|   This medication passes into breast milk. Consult your doctor||
9139|115|P|before breastfeeding.||
9139|116|B|||
9139|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9139|118|I|medications work or increase your risk for serious side effects.||
9139|119|I|This document does not contain all possible drug interactions.||
9139|120|I|Keep a list of all the products you use (including||
9139|121|I|prescription/nonprescription drugs and herbal products) and share||
9139|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
9139|123|I|the dosage of any medicines without your doctor's approval.||
9139|124|I|   This product can decrease the absorption of certain drugs,||
9139|125|I|especially if you take them around the same time. These drugs||
9139|126|I|include bisphosphonates (such as alendronate), penicillamine,||
9139|127|I|quinolone antibiotics (such as ciprofloxacin, levofloxacin),||
9139|128|I|tetracycline antibiotics (such as doxycycline, minocycline),||
9139|129|I|thyroid medications (such as levothyroxine), among others. Also,||
9139|130|I|certain medications can decrease the absorption of vitamin D||
9139|131|I|(bile acid sequestrants such as cholestyramine/colestipol,||
9139|132|I|mineral oil, orlistat). Ask your doctor or pharmacist how long||
9139|133|I|you should wait between doses of this product and your other||
9139|134|I|medications and to find a dosing schedule that works for all your||
9139|135|I|medications.||
9139|136|I|   Check the labels on all your prescription and||
9139|137|I|nonprescription/herbal products (such as antacids, laxatives,||
9139|138|I|vitamins) because they may contain calcium, phosphate, or vitamin||
9139|139|I|D. Ask your pharmacist about using those products safely.||
9139|140|I|   Vitamin D is very similar to calcitriol. Do not use||
9139|141|I|medications containing calcitriol while using vitamin D.||
9139|142|I|   This product may interfere with certain lab tests (such as||
9139|143|I|cholesterol tests), possibly causing false test results. Make||
9139|144|I|sure lab personnel and all your doctors know you use this||
9139|145|I|product.||
9139|146|B|||
9139|147|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9139|148|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9139|149|O|poison control center right away. US residents can call||
9139|150|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9139|151|O|Symptoms of overdose may include: nausea/vomiting, loss of||
9139|152|O|appetite, mental/mood changes, headache, drowsiness, weakness,||
9139|153|O|tiredness.||
9139|154|B|||
9139|155|N|NOTES:  Lab and/or medical tests (such as calcium levels) should||
9139|156|N|be done while you are taking this medication. Keep all medical||
9139|157|N|and lab appointments. Consult your doctor for more details.||
9139|158|N|   Foods rich in vitamin D include: fortified dairy products,||
9139|159|N|eggs, sardines, cod liver oil, chicken livers, and fatty fish.||
9139|160|N|Vitamin D is also made by the body as a result of exposure to the||
9139|161|N|sun.||
9139|162|N|   Foods rich in calcium include: dairy products (such as milk,||
9139|163|N|yogurt, cheese, ice cream), dark-green leafy vegetables (such as||
9139|164|N|broccoli, spinach, bok choy), and calcium-fortified foods (such||
9139|165|N|as orange juice).||
9139|166|N|   You can decrease the risk of bone disease by being physically||
9139|167|N|active, not smoking, and avoiding the use of alcohol/caffeine.||
9139|168|B|||
9139|169|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9139|170|D|remember. If it is near the time of the next dose, skip the||
9139|171|D|missed dose. Take your next dose at the regular time. Do not||
9139|172|D|double the dose to catch up.||
9139|173|B|||
9139|174|R|STORAGE:  Store at room temperature away from light and moisture.||
9139|175|R|Do not store in the bathroom. Keep all medications away from||
9139|176|R|children and pets.||
9139|177|R|   Do not flush medications down the toilet or pour them into a||
9139|178|R|drain unless instructed to do so. Properly discard this product||
9139|179|R|when it is expired or no longer needed. Consult your pharmacist||
9139|180|R|or local waste disposal company.||
9139|181|B|||
9139|182|A|Information last revised October 2025.||
9139|183|A|Copyright(c) 2025 First Databank, Inc.||
9139|184|B|||
9141|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9141|002|Z|does NOT have all possible information about this product. This||
9141|003|Z|information does not assure that this product is safe, effective,||
9141|004|Z|or appropriate for you. This information is not individual||
9141|005|Z|medical advice and does not substitute for the advice of your||
9141|006|Z|health care professional. Always ask your health care||
9141|007|Z|professional for complete information about this product and your||
9141|008|Z|specific health needs.||
9141|009|B|||
9141|010|T|TOBRAMYCIN - INJECTION||
9141|011|F|(TOE-bra-MYE-sin)||
9141|012|B|||
9141|013|C|COMMON BRAND NAME(S): Nebcin||
9141|014|B|||
9141|015|W|WARNING:  This medication can cause serious kidney problems and||
9141|016|W|nerve damage, resulting in permanent hearing loss (including||
9141|017|W|deafness or decreased hearing) and balance problems. The risk is||
9141|018|W|increased if you are older, already have kidney disease, or if||
9141|019|W|you have a severe loss of body water (dehydration). Your risk is||
9141|020|W|also increased if you receive high doses, or with longer use of||
9141|021|W|this medication.||
9141|022|W|   Tell your doctor right away if you notice ringing/roaring||
9141|023|W|sounds in the ears, hearing loss, dizziness, or an unusual||
9141|024|W|decrease in the amount of your urine.||
9141|025|W|   Careful monitoring by your doctor will reduce the risk of||
9141|026|W|these side effects. Monitoring may include hearing, kidney,||
9141|027|W|urine, and drug blood level tests.||
9141|028|W|   Avoid other medications that may increase your risk for these||
9141|029|W|serious side effects if taken together with tobramycin. See also||
9141|030|W|Drug Interactions section.||
9141|031|B|||
9141|032|U|USES:  This medication is used to prevent or treat a wide variety||
9141|033|U|of bacterial infections. Tobramycin belongs to a class of drugs||
9141|034|U|known as aminoglycoside antibiotics. It works by stopping the||
9141|035|U|growth of bacteria.||
9141|036|B|||
9141|037|H|HOW TO USE:  This medication is given by injection into a vein or||
9141|038|H|muscle as directed by your doctor, usually every 8 hours. The||
9141|039|H|dosage is based on your medical condition, weight, lab tests, and||
9141|040|H|response to treatment.||
9141|041|H|   If you are giving this medication to yourself at home, learn||
9141|042|H|all preparation and usage instructions from your health care||
9141|043|H|professional. Before using, check this product for particles or||
9141|044|H|discoloration. If either is present, do not use the liquid. Learn||
9141|045|H|how to store and discard medical supplies safely.||
9141|046|H|   For the best effect, use this antibiotic at evenly spaced||
9141|047|H|times. To help you remember, use this medication at the same||
9141|048|H|time(s) every day.||
9141|049|H|   Continue to use this medication until the full prescribed||
9141|050|H|amount is finished, even if symptoms disappear after a few days.||
9141|051|H|Stopping the medication too early may result in a return of the||
9141|052|H|infection.||
9141|053|H|   Tell your doctor if your condition lasts or gets worse.||
9141|054|B|||
9141|055|S|SIDE EFFECTS:  See also Warning section.||
9141|056|S|   Nausea, vomiting, stomach upset, or loss of appetite may||
9141|057|S|occur. Pain/irritation/redness at the injection site may rarely||
9141|058|S|occur. If any of these effects last or get worse, tell your||
9141|059|S|doctor or pharmacist promptly.||
9141|060|S|   Remember that this medication has been prescribed because your||
9141|061|S|doctor has judged that the benefit to you is greater than the||
9141|062|S|risk of side effects. Many people using this medication do not||
9141|063|S|have serious side effects.||
9141|064|S|   Tell your doctor right away if you have any serious side||
9141|065|S|effects, including: numbness/tingling, muscle twitching or||
9141|066|S|weakness, seizure.||
9141|067|S|   This medication may rarely cause a severe intestinal condition||
9141|068|S|due to a bacteria called C. difficile. This condition may occur||
9141|069|S|during treatment or weeks to months after treatment has stopped.||
9141|070|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9141|071|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9141|072|S|stool.||
9141|073|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9141|074|S|products because they may make symptoms worse.||
9141|075|S|   Use of this medication for prolonged or repeated periods may||
9141|076|S|result in oral thrush or a new yeast infection. Contact your||
9141|077|S|doctor if you notice white patches in your mouth, a change in||
9141|078|S|vaginal discharge, or other new symptoms.||
9141|079|S|   A very serious allergic reaction to this drug is rare.||
9141|080|S|However, get medical help right away if you notice any symptoms||
9141|081|S|of a serious allergic reaction, including: rash, itching/swelling||
9141|082|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9141|083|S|breathing.||
9141|084|S|   This is not a complete list of possible side effects. If you||
9141|085|S|notice other effects not listed above, contact your doctor or||
9141|086|S|pharmacist.||
9141|087|S|   In the US -||
9141|088|S|   Call your doctor for medical advice about side effects. You||
9141|089|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9141|090|S|www.fda.gov/medwatch.||
9141|091|S|   In Canada - Call your doctor for medical advice about side||
9141|092|S|effects. You may report side effects to Health Canada at||
9141|093|S|1-866-234-2345.||
9141|094|B|||
9141|095|P|PRECAUTIONS:  Before using tobramycin, tell your doctor or||
9141|096|P|pharmacist if you are allergic to it; or to other aminoglycoside||
9141|097|P|antibiotics (such as gentamicin); or if you have any other||
9141|098|P|allergies. This product may contain inactive ingredients (such as||
9141|099|P|sulfites), which can cause allergic reactions or other problems.||
9141|100|P|Talk to your pharmacist for more details.||
9141|101|P|   Before using this medication, tell your doctor or pharmacist||
9141|102|P|your medical history, especially of: cystic fibrosis, hearing||
9141|103|P|problems (including deafness, decreased hearing), kidney||
9141|104|P|problems, low blood minerals (including potassium, magnesium,||
9141|105|P|calcium), myasthenia gravis, Parkinson's disease.||
9141|106|P|   Tobramycin may cause live bacterial vaccines (such as typhoid||
9141|107|P|vaccine) to not work well. Tell your health care professional||
9141|108|P|that you are using tobramycin before having any||
9141|109|P|immunizations/vaccinations.||
9141|110|P|   Before having surgery, tell your doctor or dentist about all||
9141|111|P|the products you use (including prescription drugs,||
9141|112|P|nonprescription drugs, and herbal products).||
9141|113|P|   Older adults may be more sensitive to the effects of this||
9141|114|P|drug, especially kidney damage.||
9141|115|P|   This medication is not recommended for use during pregnancy.||
9141|116|P|Although there have been reports of harm in babies born to women||
9141|117|P|using similar drugs, the risk for harm may not be the same with||
9141|118|P|this drug. Discuss the risks and benefits with your doctor.||
9141|119|P|   This drug passes into breast milk in very small amounts.||
9141|120|P|However, many doctors consider breastfeeding safe while using||
9141|121|P|this medication. Consult your doctor before breastfeeding.||
9141|122|B|||
9141|123|I|DRUG INTERACTIONS:  See also Warning section.||
9141|124|I|   Drug interactions may change how your medications work or||
9141|125|I|increase your risk for serious side effects. This document does||
9141|126|I|not contain all possible drug interactions. Keep a list of all||
9141|127|I|the products you use (including prescription/nonprescription||
9141|128|I|drugs and herbal products) and share it with your doctor and||
9141|129|I|pharmacist. Do not start, stop, or change the dosage of any||
9141|130|I|medicines without your doctor's approval.||
9141|131|I|   Other medications that may affect the kidneys or hearing may||
9141|132|I|increase the risk of kidney damage or hearing loss if taken with||
9141|133|I|tobramycin. Some affected drugs include: amikacin, amphotericin||
9141|134|I|B, cidofovir, cisplatin, polymyxin B, cephalosporins such as||
9141|135|I|cephaloridine, nonsteroidal anti-inflammatory drugs (NSAIDs) such||
9141|136|I|as ibuprofen, among others.||
9141|137|B|||
9141|138|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9141|139|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9141|140|O|poison control center right away. US residents can call||
9141|141|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9141|142|B|||
9141|143|N|NOTES:  Lab and/or medical tests (such as kidney function, levels||
9141|144|N|of drug in your blood) may be done while you are using this||
9141|145|N|medication. Keep all medical and lab appointments. Consult your||
9141|146|N|doctor for more details.||
9141|147|B|||
9141|148|D|MISSED DOSE:  It is important to get each dose of this medication||
9141|149|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9141|150|D|right away for a new dosing schedule. Do not double the dose to||
9141|151|D|catch up.||
9141|152|B|||
9141|153|R|STORAGE:  Consult the product instructions and your pharmacist||
9141|154|R|for storage details. Keep all medications away from children and||
9141|155|R|pets.||
9141|156|R|   Do not flush medications down the toilet or pour them into a||
9141|157|R|drain unless instructed to do so. Properly discard this product||
9141|158|R|when it is expired or no longer needed. Consult your pharmacist||
9141|159|R|or local waste disposal company.||
9141|160|B|||
9141|161|A|Information last revised November 2024.||
9141|162|A|Copyright(c) 2025 First Databank, Inc.||
9141|163|B|||
9143|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9143|002|Z|does NOT have all possible information about this product. This||
9143|003|Z|information does not assure that this product is safe, effective,||
9143|004|Z|or appropriate for you. This information is not individual||
9143|005|Z|medical advice and does not substitute for the advice of your||
9143|006|Z|health care professional. Always ask your health care||
9143|007|Z|professional for complete information about this product and your||
9143|008|Z|specific health needs.||
9143|009|B|||
9143|010|T|LANSOPRAZOLE DELAYED-RELEASE CAPSULE - ORAL||
9143|011|F|(lan-SO-pruh-zole)||
9143|012|B|||
9143|013|C|COMMON BRAND NAME(S): Prevacid||
9143|014|B|||
9143|015|U|USES:  Lansoprazole is used to treat certain stomach and||
9143|016|U|esophagus problems (such as acid reflux, ulcers). It works by||
9143|017|U|decreasing the amount of acid your stomach makes. It relieves||
9143|018|U|symptoms such as heartburn, difficulty swallowing, and cough.||
9143|019|U|This medication helps heal acid damage to the stomach and||
9143|020|U|esophagus, helps prevent ulcers, and may help prevent cancer of||
9143|021|U|the esophagus. Lansoprazole belongs to a class of drugs known as||
9143|022|U|proton pump inhibitors (PPIs).||
9143|023|U|   If you are self-treating with this medication,||
9143|024|U|over-the-counter lansoprazole products are used to treat frequent||
9143|025|U|heartburn (occurring 2 or more days a week). Since it may take 1||
9143|026|U|to 4 days to have full effect, these products do not relieve||
9143|027|U|heartburn right away.||
9143|028|U|   For over-the-counter products, carefully read the package||
9143|029|U|instructions to make sure the product is right for you. Check the||
9143|030|U|ingredients on the label even if you have used the product||
9143|031|U|before. The manufacturer may have changed the ingredients. Also,||
9143|032|U|products with similar brand names may contain different||
9143|033|U|ingredients meant for different purposes. Taking the wrong||
9143|034|U|product could harm you.||
9143|035|U|   Lansoprazole is not recommended for use in children younger||
9143|036|U|than 1 year due to an increased risk of serious side effects. Ask||
9143|037|U|the doctor or pharmacist for details.||
9143|038|B|||
9143|039|H|HOW TO USE:  Read the Medication Guide and, if available, the||
9143|040|H|Patient Information Leaflet provided by your pharmacist before||
9143|041|H|you start taking lansoprazole and each time you get a refill. If||
9143|042|H|you have any questions, ask your doctor or pharmacist.||
9143|043|H|   Take this medication by mouth before a meal as directed by||
9143|044|H|your doctor, usually once daily. If you are self-treating, follow||
9143|045|H|all directions on the product package. The dosage and length of||
9143|046|H|treatment are based on your medical condition and response to||
9143|047|H|treatment. Children's dosage is also based on age and weight. Do||
9143|048|H|not increase your dose or take this drug more often than||
9143|049|H|directed. If you have any questions, ask your doctor or||
9143|050|H|pharmacist.||
9143|051|H|   Do not crush or chew the capsules. Swallow the medication||
9143|052|H|whole. If you have trouble swallowing the capsule, you may open||
9143|053|H|the capsule and sprinkle its contents on a spoonful of soft food||
9143|054|H|(such as applesauce, cottage cheese, yogurt) and swallow the||
9143|055|H|mixture right away without chewing it. Or you may empty the||
9143|056|H|capsule's contents into a small amount (2 ounces or 60||
9143|057|H|milliliters) of juice, stir, and drink the mixture right away||
9143|058|H|without chewing it. Then rinse the glass with more juice and||
9143|059|H|drink to make sure you have taken the entire dose. Do not prepare||
9143|060|H|the mixture ahead of time for later use. Doing so may destroy the||
9143|061|H|drug.||
9143|062|H|   If you are giving this medication through a tube into the||
9143|063|H|stomach (nasogastric tube), ask your health care professional for||
9143|064|H|detailed instructions on how to properly mix and give it.||
9143|065|H|   If needed, antacids may be taken along with this medication.||
9143|066|H|If you are also taking sucralfate, take lansoprazole at least 30||
9143|067|H|minutes before sucralfate.||
9143|068|H|   Use this medication regularly to get the most benefit from it.||
9143|069|H|To help you remember, take it at the same time each day. Continue||
9143|070|H|to take this medication for the prescribed length of treatment||
9143|071|H|even if you are feeling better. If you are self-treating with the||
9143|072|H|over-the-counter product, do not take it for more than 14 days||
9143|073|H|unless directed by your doctor.||
9143|074|H|   Tell your doctor if your condition lasts or gets worse. If you||
9143|075|H|are self-treating, tell your doctor if your heartburn lasts after||
9143|076|H|14 days or if you need to use this medication more than once||
9143|077|H|every 4 months. The risk of side effects goes up over time. Ask||
9143|078|H|your doctor how long you should take this medication. If you||
9143|079|H|think you may have a serious medical problem, get medical help||
9143|080|H|right away.||
9143|081|B|||
9143|082|S|SIDE EFFECTS:  Diarrhea, abdominal pain, or headache may occur.||
9143|083|S|If any of these effects last or get worse, tell your doctor or||
9143|084|S|pharmacist promptly.||
9143|085|S|   If your doctor has directed you to use this product, remember||
9143|086|S|that your doctor has judged that the benefit to you is greater||
9143|087|S|than the risk of side effects. Many people using this medication||
9143|088|S|do not have serious side effects.||
9143|089|S|   Tell your doctor right away if you have any serious side||
9143|090|S|effects, including: symptoms of a low magnesium blood level (such||
9143|091|S|as muscle spasms, irregular heartbeat, seizures), signs of lupus||
9143|092|S|(such as rash on nose and cheeks, new or worsening joint pain),||
9143|093|S|signs of kidney problems (such as change in the amount of urine,||
9143|094|S|pink/bloody urine).||
9143|095|S|   This medication may rarely cause a severe intestinal condition||
9143|096|S|due to a bacteria called C. difficile. This condition may occur||
9143|097|S|during treatment or weeks to months after treatment has stopped.||
9143|098|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9143|099|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9143|100|S|stool.||
9143|101|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9143|102|S|products because they may make symptoms worse.||
9143|103|S|   Rarely, proton pump inhibitors (such as lansoprazole) have||
9143|104|S|caused vitamin B-12 deficiency. The risk is increased if they are||
9143|105|S|taken every day for a long time (3 years or longer). Tell your||
9143|106|S|doctor right away if you develop symptoms of vitamin B-12||
9143|107|S|deficiency (such as unusual weakness, sore tongue, or||
9143|108|S|numbness/tingling of the hands/feet).||
9143|109|S|   A very serious allergic reaction to this drug is rare.||
9143|110|S|However, get medical help right away if you notice any symptoms||
9143|111|S|of a serious allergic reaction, including: fever, swollen lymph||
9143|112|S|nodes, rash, itching/swelling (especially of the||
9143|113|S|face/tongue/throat), severe dizziness, trouble breathing.||
9143|114|S|   This is not a complete list of possible side effects. If you||
9143|115|S|notice other effects not listed above, contact your doctor or||
9143|116|S|pharmacist.||
9143|117|S|   In the US -||
9143|118|S|   Call your doctor for medical advice about side effects. You||
9143|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9143|120|S|www.fda.gov/medwatch.||
9143|121|S|   In Canada - Call your doctor for medical advice about side||
9143|122|S|effects. You may report side effects to Health Canada at||
9143|123|S|1-866-234-2345.||
9143|124|B|||
9143|125|P|PRECAUTIONS:  Before taking lansoprazole, tell your doctor or||
9143|126|P|pharmacist if you are allergic to it; or to similar drugs (such||
9143|127|P|as dexlansoprazole, omeprazole, pantoprazole); or if you have any||
9143|128|P|other allergies. This product may contain inactive ingredients,||
9143|129|P|which can cause allergic reactions or other problems. Talk to||
9143|130|P|your pharmacist for more details.||
9143|131|P|   Before using this medication, tell your doctor or pharmacist||
9143|132|P|your medical history, especially of: liver disease, lupus.||
9143|133|P|   Some symptoms may actually be signs of a more serious||
9143|134|P|condition. Get medical help right away if you have: heartburn||
9143|135|P|with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder||
9143|136|P|pain (especially with shortness of breath, unusual sweating),||
9143|137|P|unexplained weight loss.||
9143|138|P|   In addition, before you self-treat with this medication, get||
9143|139|P|medical help right away if you have any of these signs of a||
9143|140|P|serious condition: trouble/pain swallowing food, bloody vomit,||
9143|141|P|vomit that looks like coffee grounds, bloody/black stools,||
9143|142|P|heartburn for over 3 months, frequent chest pain, frequent||
9143|143|P|wheezing (especially with heartburn), nausea/vomiting, stomach||
9143|144|P|pain.||
9143|145|P|   Before having surgery, tell your doctor or dentist about all||
9143|146|P|the products you use (including prescription drugs,||
9143|147|P|nonprescription drugs, and herbal products).||
9143|148|P|   Proton pump inhibitors (such as lansoprazole) may increase||
9143|149|P|your risk for bone fractures, especially with longer use, higher||
9143|150|P|doses, and in older adults. Talk with your doctor or pharmacist||
9143|151|P|about ways to prevent bone loss/fracture, such as by taking||
9143|152|P|calcium (such as calcium citrate) and vitamin D supplements.||
9143|153|P|   Older adults may be more sensitive to the side effects of this||
9143|154|P|drug, especially bone loss and fractures (see above), and C.||
9143|155|P|difficile infection (see Side Effects section).||
9143|156|P|   During pregnancy, this medication should be used only when||
9143|157|P|clearly needed. Discuss the risks and benefits with your doctor.||
9143|158|P|   It is unknown if this medication passes into breast milk.||
9143|159|P|However, similar drugs pass into breast milk. The effects on a||
9143|160|P|nursing infant are unknown. Consult your doctor before||
9143|161|P|breastfeeding.||
9143|162|B|||
9143|163|I|DRUG INTERACTIONS:  See also How to Use section.||
9143|164|I|   Drug interactions may change how your medications work or||
9143|165|I|increase your risk for serious side effects. This document does||
9143|166|I|not contain all possible drug interactions. Keep a list of all||
9143|167|I|the products you use (including prescription/nonprescription||
9143|168|I|drugs and herbal products) and share it with your doctor and||
9143|169|I|pharmacist. Do not start, stop, or change the dosage of any||
9143|170|I|medicines without your doctor's approval.||
9143|171|I|   A product that may interact with this drug is: methotrexate||
9143|172|I|(especially high-dose treatment).||
9143|173|I|   Some products need stomach acid so that the body can absorb||
9143|174|I|them properly. Lansoprazole decreases stomach acid, so it may||
9143|175|I|change how well these products work. Some affected products||
9143|176|I|include ampicillin, atazanavir, erlotinib, levoketoconazole,||
9143|177|I|nelfinavir, pazopanib, rilpivirine, sparsentan, certain azole||
9143|178|I|antifungals (itraconazole, ketoconazole, posaconazole), among||
9143|179|I|others.||
9143|180|I|   Lansoprazole is very similar to dexlansoprazole. Do not use||
9143|181|I|medications containing dexlansoprazole while using lansoprazole.||
9143|182|I|   This medication may interfere with certain lab tests, possibly||
9143|183|I|causing false test results. Make sure lab personnel and all your||
9143|184|I|doctors know you use this drug.||
9143|185|B|||
9143|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9143|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9143|188|O|poison control center right away. US residents can call||
9143|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9143|190|B|||
9143|191|N|NOTES:  If your doctor has prescribed this medication for you, do||
9143|192|N|not share it with others.||
9143|193|N|   If your doctor instructs you to use this medication regularly||
9143|194|N|for a long time, lab and/or medical tests (such as a magnesium||
9143|195|N|blood test, vitamin B-12 levels) may be done while you are taking||
9143|196|N|this medication. Keep all medical and lab appointments. Consult||
9143|197|N|your doctor for more details.||
9143|198|B|||
9143|199|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9143|200|D|remember. If it is near the time of the next dose, skip the||
9143|201|D|missed dose. Take your next dose at the regular time. Do not||
9143|202|D|double the dose to catch up.||
9143|203|B|||
9143|204|R|STORAGE:  Store at room temperature away from light and moisture.||
9143|205|R|Do not store in the bathroom. Keep all medications away from||
9143|206|R|children and pets.||
9143|207|R|   Do not flush medications down the toilet or pour them into a||
9143|208|R|drain unless instructed to do so. Properly discard this product||
9143|209|R|when it is expired or no longer needed. Consult your pharmacist||
9143|210|R|or local waste disposal company.||
9143|211|B|||
9143|212|A|Information last revised June 2024.||
9143|213|A|Copyright(c) 2025 First Databank, Inc.||
9143|214|B|||
9151|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9151|002|Z|does NOT have all possible information about this product. This||
9151|003|Z|information does not assure that this product is safe, effective,||
9151|004|Z|or appropriate for you. This information is not individual||
9151|005|Z|medical advice and does not substitute for the advice of your||
9151|006|Z|health care professional. Always ask your health care||
9151|007|Z|professional for complete information about this product and your||
9151|008|Z|specific health needs.||
9151|009|B|||
9151|010|T|MEROPENEM - INJECTION||
9151|011|F|(MER-oh-PEN-em)||
9151|012|B|||
9151|013|C|COMMON BRAND NAME(S): Merrem||
9151|014|B|||
9151|015|U|USES:  Meropenem is used to treat a wide variety of bacterial||
9151|016|U|infections. This medication is known as a carbapenem-type||
9151|017|U|antibiotic. It works by stopping the growth of bacteria.||
9151|018|B|||
9151|019|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9151|020|H|from your pharmacist before you start using meropenem and each||
9151|021|H|time you get a refill. If you have any questions, ask your doctor||
9151|022|H|or pharmacist.||
9151|023|H|   This medication is given by injection into a vein as directed||
9151|024|H|by your doctor, usually every 8 hours.||
9151|025|H|   If you are using this medication at home, learn all||
9151|026|H|preparation and usage instructions from your health care||
9151|027|H|professional. Before using, check this product for particles or||
9151|028|H|discoloration. If either is present, do not use the liquid. Learn||
9151|029|H|how to store and discard medical supplies safely.||
9151|030|H|   The dosage is based on your medical condition and response to||
9151|031|H|treatment. Children's dosage is also based on age and weight.||
9151|032|H|   For the best effect, use this antibiotic at evenly spaced||
9151|033|H|times. To help you remember, use this medication at the same||
9151|034|H|time(s) every day.||
9151|035|H|   Continue to use this medication until the full prescribed||
9151|036|H|treatment period is finished, even if symptoms disappear after a||
9151|037|H|few days. Stopping the medication too early may result in a||
9151|038|H|return of the infection.||
9151|039|H|   Tell your doctor if your condition lasts or gets worse.||
9151|040|B|||
9151|041|S|SIDE EFFECTS:  Swelling, redness, pain, or soreness at the||
9151|042|S|injection site may occur. Upset stomach, headache, nausea,||
9151|043|S|vomiting, constipation, or diarrhea may also occur. If any of||
9151|044|S|these effects last or get worse, tell your doctor or pharmacist||
9151|045|S|promptly.||
9151|046|S|   Remember that this medication has been prescribed because your||
9151|047|S|doctor has judged that the benefit to you is greater than the||
9151|048|S|risk of side effects. Many people using this medication do not||
9151|049|S|have serious side effects.||
9151|050|S|   Tell your doctor right away if you have any serious side||
9151|051|S|effects, including: easy bruising/bleeding, hearing changes (such||
9151|052|S|as decreased hearing, ringing in the ears), mental/mood changes||
9151|053|S|(such as confusion), numb/tingling skin, swelling ankles/feet,||
9151|054|S|unusual weight gain, unusual tiredness, muscle||
9151|055|S|pain/tenderness/weakness, signs of kidney problems (such as||
9151|056|S|change in the amount of urine).||
9151|057|S|   Get medical help right away if you have any very serious side||
9151|058|S|effects, including: seizures, unusual weakness.||
9151|059|S|   This medication may rarely cause a severe intestinal condition||
9151|060|S|due to a bacteria called C. difficile. This condition may occur||
9151|061|S|during treatment or weeks to months after treatment has stopped.||
9151|062|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9151|063|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9151|064|S|stool.||
9151|065|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9151|066|S|products because they may make symptoms worse.||
9151|067|S|   Use of this medication for prolonged or repeated periods may||
9151|068|S|result in oral thrush or a new yeast infection. Contact your||
9151|069|S|doctor if you notice white patches in your mouth, a change in||
9151|070|S|vaginal discharge, or other new symptoms.||
9151|071|S|   A very serious allergic reaction to this drug is rare.||
9151|072|S|However, get medical help right away if you notice any symptoms||
9151|073|S|of a serious allergic reaction, including: fever that doesn't go||
9151|074|S|away, new or worsening lymph node swelling, rash,||
9151|075|S|itching/swelling (especially of the face/tongue/throat), severe||
9151|076|S|dizziness, trouble breathing.||
9151|077|S|   This is not a complete list of possible side effects. If you||
9151|078|S|notice other effects not listed above, contact your doctor or||
9151|079|S|pharmacist.||
9151|080|S|   In the US -||
9151|081|S|   Call your doctor for medical advice about side effects. You||
9151|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9151|083|S|www.fda.gov/medwatch.||
9151|084|S|   In Canada - Call your doctor for medical advice about side||
9151|085|S|effects. You may report side effects to Health Canada at||
9151|086|S|1-866-234-2345.||
9151|087|B|||
9151|088|P|PRECAUTIONS:  Before using meropenem, tell your doctor or||
9151|089|P|pharmacist if you are allergic to it; or to other carbapenems||
9151|090|P|(such as imipenem); or to penicillins or cephalosporins; or if||
9151|091|P|you have any other allergies. This product may contain inactive||
9151|092|P|ingredients, which can cause allergic reactions or other||
9151|093|P|problems. Talk to your pharmacist for more details.||
9151|094|P|   Before using this medication, tell your doctor or pharmacist||
9151|095|P|your medical history, especially of: brain disorders (such as||
9151|096|P|seizures, head injury, tumor), kidney disease, stomach/intestinal||
9151|097|P|diseases (such as colitis).||
9151|098|P|   This drug may rarely cause headaches, numb/tingling skin, or||
9151|099|P|seizures. Do not drive, use machinery, or do anything that needs||
9151|100|P|alertness or clear vision until you can do it safely.||
9151|101|P|   Some forms of this medication have sodium. Consult your doctor||
9151|102|P|or pharmacist if you are on a salt-restricted diet or if you have||
9151|103|P|a condition that could get worse if you have more salt (such as||
9151|104|P|heart failure).||
9151|105|P|   Meropenem may cause live bacterial vaccines (such as typhoid||
9151|106|P|vaccine) to not work well. Tell your health care professional||
9151|107|P|that you are using meropenem before having any||
9151|108|P|immunizations/vaccinations.||
9151|109|P|   Before having surgery, tell your doctor or dentist about all||
9151|110|P|the products you use (including prescription drugs,||
9151|111|P|nonprescription drugs, and herbal products).||
9151|112|P|   Tell your doctor if you are pregnant before using this||
9151|113|P|medication.||
9151|114|P|   This medication passes into breast milk. Consult your doctor||
9151|115|P|before breastfeeding.||
9151|116|B|||
9151|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9151|118|I|medications work or increase your risk for serious side effects.||
9151|119|I|This document does not contain all possible drug interactions.||
9151|120|I|Keep a list of all the products you use (including||
9151|121|I|prescription/nonprescription drugs and herbal products) and share||
9151|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
9151|123|I|the dosage of any medicines without your doctor's approval.||
9151|124|I|   Some products that may interact with this drug include:||
9151|125|I|valproic acid and related drugs (such as divalproex sodium,||
9151|126|I|sodium valproate).||
9151|127|B|||
9151|128|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9151|129|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9151|130|O|poison control center right away. US residents can call||
9151|131|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9151|132|B|||
9151|133|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
9151|134|N|kidney function) may be done while you are using this medication.||
9151|135|N|Keep all medical and lab appointments. Consult your doctor for||
9151|136|N|more details.||
9151|137|B|||
9151|138|D|MISSED DOSE:  It is important to get each dose of this medication||
9151|139|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9151|140|D|right away for a new dosing schedule. Do not double the dose to||
9151|141|D|catch up.||
9151|142|B|||
9151|143|R|STORAGE:  Consult the product instructions and your pharmacist||
9151|144|R|for storage details. Keep all medications away from children and||
9151|145|R|pets.||
9151|146|R|   Do not flush medications down the toilet or pour them into a||
9151|147|R|drain unless instructed to do so. Properly discard this product||
9151|148|R|when it is expired or no longer needed. Consult your pharmacist||
9151|149|R|or local waste disposal company.||
9151|150|B|||
9151|151|A|Information last revised April 2025.||
9151|152|A|Copyright(c) 2025 First Databank, Inc.||
9151|153|B|||
9152|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9152|002|Z|does NOT have all possible information about this product. This||
9152|003|Z|information does not assure that this product is safe, effective,||
9152|004|Z|or appropriate for you. This information is not individual||
9152|005|Z|medical advice and does not substitute for the advice of your||
9152|006|Z|health care professional. Always ask your health care||
9152|007|Z|professional for complete information about this product and your||
9152|008|Z|specific health needs.||
9152|009|B|||
9152|010|T|FLAVOXATE - ORAL||
9152|011|F|(flay-VOX-ate)||
9152|012|B|||
9152|013|C|COMMON BRAND NAME(S): Urispas||
9152|014|B|||
9152|015|U|USES:  This medication is used to treat certain bladder/urinary||
9152|016|U|tract symptoms. Flavoxate is a smooth-muscle relaxant. It works||
9152|017|U|by relaxing the muscles in the bladder. Flavoxate helps to reduce||
9152|018|U|leaking of urine, feelings of needing to urinate right away,||
9152|019|U|frequent trips to the bathroom, and bladder pain. This medication||
9152|020|U|does not treat the cause of your bladder symptoms (such as||
9152|021|U|urinary tract/bladder/prostate infection or inflammation).||
9152|022|B|||
9152|023|H|HOW TO USE:  Take this medication by mouth as directed by your||
9152|024|H|doctor, usually 3 to 4 times a day. Take with food if stomach||
9152|025|H|upset occurs.||
9152|026|H|   The dosage is based on your medical condition and response to||
9152|027|H|treatment. Your doctor may lower your dose after your symptoms||
9152|028|H|have improved. The length of treatment depends on the cause of||
9152|029|H|the problem.||
9152|030|H|   Do not increase your dose or take this medication more often||
9152|031|H|without your doctor's approval. Your condition will not improve||
9152|032|H|any faster, and the risk of side effects may be increased.||
9152|033|H|   Tell your doctor if your condition lasts or gets worse.||
9152|034|B|||
9152|035|S|SIDE EFFECTS:  Nausea, vomiting, dry mouth, headache, drowsiness,||
9152|036|S|dizziness, blurred vision, and nervousness may occur. If any of||
9152|037|S|these effects last or get worse, tell your doctor or pharmacist||
9152|038|S|promptly.||
9152|039|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
9152|040|S|chips, chew (sugarless) gum, drink water, or use a saliva||
9152|041|S|substitute.||
9152|042|S|   To prevent constipation, eat dietary fiber, drink enough||
9152|043|S|water, and exercise. You may also need to take a laxative. Ask||
9152|044|S|your pharmacist which type of laxative is right for you.||
9152|045|S|   Remember that this medication has been prescribed because your||
9152|046|S|doctor has judged that the benefit to you is greater than the||
9152|047|S|risk of side effects. Many people using this medication do not||
9152|048|S|have serious side effects.||
9152|049|S|   Tell your doctor right away if you have any serious side||
9152|050|S|effects, including: nausea/vomiting/constipation that doesn't go||
9152|051|S|away, mental/mood changes (such as confusion), eye pain, chest||
9152|052|S|pain, fast/pounding heartbeat, signs of infection (such as sore||
9152|053|S|throat that doesn't go away, fever, chills), difficult/painful||
9152|054|S|urination.||
9152|055|S|   A very serious allergic reaction to this drug is rare.||
9152|056|S|However, get medical help right away if you notice any symptoms||
9152|057|S|of a serious allergic reaction, including: rash, itching/swelling||
9152|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9152|059|S|breathing.||
9152|060|S|   This is not a complete list of possible side effects. If you||
9152|061|S|notice other effects not listed above, contact your doctor or||
9152|062|S|pharmacist.||
9152|063|S|   In the US -||
9152|064|S|   Call your doctor for medical advice about side effects. You||
9152|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9152|066|S|www.fda.gov/medwatch.||
9152|067|S|   In Canada - Call your doctor for medical advice about side||
9152|068|S|effects. You may report side effects to Health Canada at||
9152|069|S|1-866-234-2345.||
9152|070|B|||
9152|071|P|PRECAUTIONS:  Before taking flavoxate, tell your doctor or||
9152|072|P|pharmacist if you are allergic to it; or if you have any other||
9152|073|P|allergies. This product may contain inactive ingredients, which||
9152|074|P|can cause allergic reactions or other problems. Talk to your||
9152|075|P|pharmacist for more details.||
9152|076|P|   Before using this medication, tell your doctor or pharmacist||
9152|077|P|your medical history, especially of: stomach/intestinal problems||
9152|078|P|(such as blockage, bleeding, ileus, infection, acid-reflux||
9152|079|P|disease, chronic constipation, ulcerative colitis), heart||
9152|080|P|problems (such as fast/irregular heartbeat, heart failure), a||
9152|081|P|certain eye condition (glaucoma), kidney problems, a certain||
9152|082|P|muscle disease (myasthenia gravis), difficulty urinating (for||
9152|083|P|example, due to enlarged prostate), overactive thyroid||
9152|084|P|(hyperthyroidism).||
9152|085|P|   This drug may make you dizzy or drowsy or blur your vision.||
9152|086|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9152|087|P|drowsy. Do not drive, use machinery, or do anything that needs||
9152|088|P|alertness or clear vision until you can do it safely. Limit||
9152|089|P|alcoholic beverages. Talk to your doctor if you are using||
9152|090|P|marijuana (cannabis).||
9152|091|P|   This medication may make you sweat less, making you more||
9152|092|P|likely to get heat stroke. Avoid doing things that may cause you||
9152|093|P|to overheat, such as hard work or exercise in hot weather, or||
9152|094|P|using hot tubs. When the weather is hot, drink a lot of fluids||
9152|095|P|and dress lightly. If you overheat, quickly look for a place to||
9152|096|P|cool down and rest. Get medical help right away if you have a||
9152|097|P|fever that does not go away, mental/mood changes, headache, or||
9152|098|P|dizziness.||
9152|099|P|   Older adults may be more sensitive to the side effects of this||
9152|100|P|drug, especially dizziness (more likely when standing up),||
9152|101|P|drowsiness, constipation, trouble urinating, or confusion.||
9152|102|P|Dizziness, drowsiness, and confusion can increase the risk of||
9152|103|P|falling.||
9152|104|P|   During pregnancy, this medication should be used only when||
9152|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
9152|106|P|   It is unknown if this drug passes into breast milk. Consult||
9152|107|P|your doctor before breastfeeding.||
9152|108|B|||
9152|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9152|110|I|medications work or increase your risk for serious side effects.||
9152|111|I|This document does not contain all possible drug interactions.||
9152|112|I|Keep a list of all the products you use (including||
9152|113|I|prescription/nonprescription drugs and herbal products) and share||
9152|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
9152|115|I|the dosage of any medicines without your doctor's approval.||
9152|116|I|   Some products that may interact with this drug are: potassium||
9152|117|I|tablets/capsules, pramlintide.||
9152|118|I|   Tell your doctor or pharmacist if you are taking other||
9152|119|I|products that cause drowsiness such as opioid pain or cough||
9152|120|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9152|121|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9152|122|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9152|123|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
9152|124|I|diphenhydramine).||
9152|125|I|   Check the labels on all your medicines (such as allergy or||
9152|126|I|cough-and-cold products) because they may contain ingredients||
9152|127|I|that cause drowsiness. Ask your pharmacist about using those||
9152|128|I|products safely.||
9152|129|B|||
9152|130|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9152|131|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9152|132|O|poison control center right away. US residents can call||
9152|133|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9152|134|O|Symptoms of overdose may include: slow/shallow breathing,||
9152|135|O|hallucination, seizures, loss of consciousness.||
9152|136|B|||
9152|137|N|NOTES:  Do not share this medication with others.||
9152|138|N|   This medication has been prescribed for your current condition||
9152|139|N|only. Do not use it later for another condition unless told to do||
9152|140|N|so by your doctor. A different medication may be necessary in||
9152|141|N|that case.||
9152|142|N|   This medication may relieve the symptoms of a bladder||
9152|143|N|infection, urinary tract infection (UTI), or prostate infection.||
9152|144|N|However, it does not treat an infection. An antibiotic may be||
9152|145|N|needed if you have an infection.||
9152|146|B|||
9152|147|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9152|148|D|remember. If it is near the time of the next dose, skip the||
9152|149|D|missed dose. Take your next dose at the regular time. Do not||
9152|150|D|double the dose to catch up.||
9152|151|B|||
9152|152|R|STORAGE:  Store at room temperature away from light and moisture.||
9152|153|R|Do not store in the bathroom. Keep all medications away from||
9152|154|R|children and pets.||
9152|155|R|   Do not flush medications down the toilet or pour them into a||
9152|156|R|drain unless instructed to do so. Properly discard this product||
9152|157|R|when it is expired or no longer needed. Consult your pharmacist||
9152|158|R|or local waste disposal company.||
9152|159|B|||
9152|160|A|Information last revised October 2025.||
9152|161|A|Copyright(c) 2025 First Databank, Inc.||
9152|162|B|||
9153|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9153|002|Z|does NOT have all possible information about this product. This||
9153|003|Z|information does not assure that this product is safe, effective,||
9153|004|Z|or appropriate for you. This information is not individual||
9153|005|Z|medical advice and does not substitute for the advice of your||
9153|006|Z|health care professional. Always ask your health care||
9153|007|Z|professional for complete information about this product and your||
9153|008|Z|specific health needs.||
9153|009|B|||
9153|010|T|PENTAMIDINE ISETHIONATE - INJECTION||
9153|011|F|(pen-TAM-ih-deen eye-seh-THIGH-oh-nate)||
9153|012|B|||
9153|013|C|COMMON BRAND NAME(S): Pentam 300||
9153|014|B|||
9153|015|U|USES:  Pentamidine is used to treat a serious lung infection||
9153|016|U|(Pneumocystis pneumonia-PCP) in people with immune system||
9153|017|U|problems, including people with acquired immunodeficiency||
9153|018|U|syndrome (AIDS). Pentamidine belongs to a class of drugs known as||
9153|019|U|antiprotozoals. It works by killing the organism that causes the||
9153|020|U|infection.||
9153|021|B|||
9153|022|V|OTHER USES:  This section contains uses of this drug that are not||
9153|023|V|listed in the approved professional labeling for the drug but||
9153|024|V|that may be prescribed by your health care professional. Use this||
9153|025|V|drug for a condition that is listed in this section only if it||
9153|026|V|has been so prescribed by your health care professional.||
9153|027|V|   This drug may also be used for certain parasite infections||
9153|028|V|(such as leishmaniasis, trypanosomiasis, babesiosis).||
9153|029|B|||
9153|030|H|HOW TO USE:  This medication is given by injection into a vein or||
9153|031|H|muscle as directed by your doctor, usually once a day. If it is||
9153|032|H|given by injection into a vein, it is slowly injected over 1 to 2||
9153|033|H|hours. Tell your doctor right away if you notice leakage,||
9153|034|H|redness, or pain during an injection into your vein. If this||
9153|035|H|medication is given by injection into a muscle, it is usually||
9153|036|H|injected into the buttock/hip area.||
9153|037|H|   The dosage is based on your medical condition, weight, and||
9153|038|H|response to treatment.||
9153|039|H|   If you are giving this medication to yourself at home, learn||
9153|040|H|all preparation and usage instructions from your health care||
9153|041|H|professional. Before using, check this product for particles or||
9153|042|H|discoloration. If either is present, do not use the liquid. Learn||
9153|043|H|how to store and discard medical supplies safely.||
9153|044|H|   Tell your doctor if your condition does not get better or if||
9153|045|H|it gets worse.||
9153|046|B|||
9153|047|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, unusual||
9153|048|S|taste/dryness in the mouth, dizziness, diarrhea, or||
9153|049|S|redness/pain/leakage at the injection site may occur. If any of||
9153|050|S|these effects last or get worse, tell your doctor or pharmacist||
9153|051|S|promptly.||
9153|052|S|   People using this medication may have serious side effects.||
9153|053|S|However, you have been prescribed this drug because your doctor||
9153|054|S|has judged that the benefit to you is greater than the risk of||
9153|055|S|side effects. Careful monitoring by your doctor may decrease your||
9153|056|S|risk.||
9153|057|S|   Tell your doctor right away if you have any serious side||
9153|058|S|effects, including: easy bruising/bleeding, mental/mood changes||
9153|059|S|(such as confusion, hallucinations), signs of kidney problems||
9153|060|S|(such as change in the amount of urine), signs of anemia (such as||
9153|061|S|severe tiredness, pale skin, bluish skin/nails), signs of low||
9153|062|S|blood sugar (such as sudden sweating, shaking, hunger), signs of||
9153|063|S|another infection (such as sore throat that doesn't go away,||
9153|064|S|increased fever, chills), abdominal pain, signs of high blood||
9153|065|S|sugar (such as unusual increase in thirst or urination).||
9153|066|S|   Get medical help right away if you have any very serious side||
9153|067|S|effects, including: fast/irregular heartbeat, severe dizziness,||
9153|068|S|fainting.||
9153|069|S|   A very serious allergic reaction to this drug is rare.||
9153|070|S|However, get medical help right away if you notice any symptoms||
9153|071|S|of a serious allergic reaction, including: rash, itching/swelling||
9153|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9153|073|S|breathing.||
9153|074|S|   This is not a complete list of possible side effects. If you||
9153|075|S|notice other effects not listed above, contact your doctor or||
9153|076|S|pharmacist.||
9153|077|S|   In the US -||
9153|078|S|   Call your doctor for medical advice about side effects. You||
9153|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9153|080|S|www.fda.gov/medwatch.||
9153|081|S|   In Canada - Call your doctor for medical advice about side||
9153|082|S|effects. You may report side effects to Health Canada at||
9153|083|S|1-866-234-2345.||
9153|084|B|||
9153|085|P|PRECAUTIONS:  Before using pentamidine, tell your doctor or||
9153|086|P|pharmacist if you are allergic to it; or if you have any other||
9153|087|P|allergies. This product may contain inactive ingredients, which||
9153|088|P|can cause allergic reactions or other problems. Talk to your||
9153|089|P|pharmacist for more details.||
9153|090|P|   Before using this medication, tell your doctor or pharmacist||
9153|091|P|your medical history, especially of: bleeding/blood disorders,||
9153|092|P|heart problems, high or low blood pressure, diabetes, kidney||
9153|093|P|disease, liver problems, pancreatitis.||
9153|094|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9153|095|P|can make you more dizzy. Do not drive, use machinery, or do||
9153|096|P|anything that needs alertness until you can do it safely. Limit||
9153|097|P|alcoholic beverages. Talk to your doctor if you are using||
9153|098|P|marijuana (cannabis).||
9153|099|P|   Pentamidine may cause a condition that affects the heart||
9153|100|P|rhythm (QT prolongation). QT prolongation can rarely cause||
9153|101|P|serious (rarely fatal) fast/irregular heartbeat and other||
9153|102|P|symptoms (such as severe dizziness, fainting) that need medical||
9153|103|P|attention right away.||
9153|104|P|   The risk of QT prolongation may be increased if you have||
9153|105|P|certain medical conditions or are taking other drugs that may||
9153|106|P|cause QT prolongation. Before using pentamidine, tell your doctor||
9153|107|P|or pharmacist of all the drugs you take and if you have any of||
9153|108|P|the following conditions: certain heart problems (heart failure,||
9153|109|P|slow heartbeat, QT prolongation in the EKG), family history of||
9153|110|P|certain heart problems (QT prolongation in the EKG, sudden||
9153|111|P|cardiac death).||
9153|112|P|   Low levels of potassium or magnesium in the blood may also||
9153|113|P|increase your risk of QT prolongation. This risk may increase if||
9153|114|P|you use certain drugs (such as diuretics/"water pills") or if you||
9153|115|P|have conditions such as severe sweating, diarrhea, or vomiting.||
9153|116|P|Talk to your doctor about using pentamidine safely.||
9153|117|P|   Before having surgery, tell your doctor or dentist about all||
9153|118|P|the products you use (including prescription drugs,||
9153|119|P|nonprescription drugs, and herbal products).||
9153|120|P|   Older adults may be more sensitive to the side effects of this||
9153|121|P|drug, especially QT prolongation (see above).||
9153|122|P|   During pregnancy, this medication should be used only when||
9153|123|P|clearly needed. Discuss the risks and benefits with your doctor.||
9153|124|P|   It is unknown if this medication passes into breast milk.||
9153|125|P|Consult your doctor before breastfeeding.||
9153|126|B|||
9153|127|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9153|128|I|medications work or increase your risk for serious side effects.||
9153|129|I|This document does not contain all possible drug interactions.||
9153|130|I|Keep a list of all the products you use (including||
9153|131|I|prescription/nonprescription drugs and herbal products) and share||
9153|132|I|it with your doctor and pharmacist. Do not start, stop, or change||
9153|133|I|the dosage of any medicines without your doctor's approval.||
9153|134|I|   Many drugs besides pentamidine may affect the heart rhythm (QT||
9153|135|I|prolongation), including amiodarone, dofetilide, pimozide,||
9153|136|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
9153|137|I|erythromycin), among others.||
9153|138|B|||
9153|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9153|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9153|141|O|poison control center right away. US residents can call||
9153|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9153|143|B|||
9153|144|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
9153|145|N|blood pressure, blood sugar, complete blood counts, EKGs) should||
9153|146|N|be done before you start using this medication, while you are||
9153|147|N|using it, and after your treatment. Keep all medical and lab||
9153|148|N|appointments. Consult your doctor for more details.||
9153|149|B|||
9153|150|D|MISSED DOSE:  It is important to get each dose of this medication||
9153|151|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9153|152|D|right away for a new dosing schedule. Do not double the dose to||
9153|153|D|catch up.||
9153|154|B|||
9153|155|R|STORAGE:  Consult the product instructions and your pharmacist||
9153|156|R|for storage details. Keep all medications away from children and||
9153|157|R|pets.||
9153|158|R|   Do not flush medications down the toilet or pour them into a||
9153|159|R|drain unless instructed to do so. Properly discard this product||
9153|160|R|when it is expired or no longer needed. Consult your pharmacist||
9153|161|R|or local waste disposal company.||
9153|162|B|||
9153|163|A|Information last revised November 2024.||
9153|164|A|Copyright(c) 2025 First Databank, Inc.||
9153|165|B|||
9154|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9154|002|Z|does NOT have all possible information about this product. This||
9154|003|Z|information does not assure that this product is safe, effective,||
9154|004|Z|or appropriate for you. This information is not individual||
9154|005|Z|medical advice and does not substitute for the advice of your||
9154|006|Z|health care professional. Always ask your health care||
9154|007|Z|professional for complete information about this product and your||
9154|008|Z|specific health needs.||
9154|009|B|||
9154|010|T|VANCOMYCIN - ORAL||
9154|011|F|(VAN-koe-MYE-sin)||
9154|012|B|||
9154|013|C|COMMON BRAND NAME(S): Vancocin||
9154|014|B|||
9154|015|U|USES:  Vancomycin is used to treat a certain intestinal condition||
9154|016|U|(colitis) that may rarely happen after treatment with||
9154|017|U|antibiotics. This condition causes diarrhea and stomach/abdominal||
9154|018|U|discomfort or pain. When vancomycin is taken by mouth, it stays||
9154|019|U|in the intestines to stop the growth of bacteria that cause these||
9154|020|U|symptoms.||
9154|021|U|   This antibiotic treats only bacterial infection in the||
9154|022|U|intestines. It will not work for bacterial infections in any||
9154|023|U|other part of the body or for viral infections (such as common||
9154|024|U|cold, flu). Using any antibiotic when it is not needed can cause||
9154|025|U|it to not work for future infections.||
9154|026|B|||
9154|027|H|HOW TO USE:  Take this medication by mouth as directed by your||
9154|028|H|doctor, usually every 6 to 8 hours. The dosage is based on your||
9154|029|H|medical condition and response to treatment. Children's dosage is||
9154|030|H|also based on weight.||
9154|031|H|   If you are also taking certain bile acid-binding cholesterol||
9154|032|H|medication (such as cholestyramine, colestipol), take it at least||
9154|033|H|3 to 4 hours after taking vancomycin. Taking them together will||
9154|034|H|make vancomycin work less well. Ask your pharmacist if you have||
9154|035|H|questions.||
9154|036|H|   For the best effect, take this antibiotic at evenly spaced||
9154|037|H|times. To help you remember, take this medication at the same||
9154|038|H|times every day.||
9154|039|H|   Continue to take this medication until the full prescribed||
9154|040|H|amount is finished, even if symptoms disappear after a few days.||
9154|041|H|Stopping the medication too early may result in a return of the||
9154|042|H|infection.||
9154|043|H|   Tell your doctor if your condition lasts or gets worse.||
9154|044|B|||
9154|045|S|SIDE EFFECTS:  Nausea or stomach upset may occur. If either of||
9154|046|S|these effects lasts or gets worse, tell your doctor or pharmacist||
9154|047|S|promptly.||
9154|048|S|   Remember that this medication has been prescribed because your||
9154|049|S|doctor has judged that the benefit to you is greater than the||
9154|050|S|risk of side effects. Many people using this medication do not||
9154|051|S|have serious side effects.||
9154|052|S|   Tell your doctor right away if you have any serious side||
9154|053|S|effects, including: dizziness, hearing problems (such as ringing||
9154|054|S|in the ears, hearing loss), easy bruising/bleeding, signs of||
9154|055|S|kidney problems (such as change in the amount of urine).||
9154|056|S|   A very serious allergic reaction to this drug is rare.||
9154|057|S|However, get medical help right away if you notice any symptoms||
9154|058|S|of a serious allergic reaction, including: fever that doesn't go||
9154|059|S|away, new or worsening lymph node swelling, rash,||
9154|060|S|itching/swelling (especially of the face/tongue/throat), severe||
9154|061|S|dizziness, trouble breathing.||
9154|062|S|   This is not a complete list of possible side effects. If you||
9154|063|S|notice other effects not listed above, contact your doctor or||
9154|064|S|pharmacist.||
9154|065|S|   In the US -||
9154|066|S|   Call your doctor for medical advice about side effects. You||
9154|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9154|068|S|www.fda.gov/medwatch.||
9154|069|S|   In Canada - Call your doctor for medical advice about side||
9154|070|S|effects. You may report side effects to Health Canada at||
9154|071|S|1-866-234-2345.||
9154|072|B|||
9154|073|P|PRECAUTIONS:  Before taking vancomycin, tell your doctor or||
9154|074|P|pharmacist if you are allergic to it; or if you have any other||
9154|075|P|allergies. This product may contain inactive ingredients, which||
9154|076|P|can cause allergic reactions or other problems. Talk to your||
9154|077|P|pharmacist for more details.||
9154|078|P|   Before using this medication, tell your doctor or pharmacist||
9154|079|P|your medical history, especially of: kidney disease, hearing||
9154|080|P|problems, other stomach/intestinal problems.||
9154|081|P|   Before having surgery, tell your doctor or dentist about all||
9154|082|P|the products you use (including prescription drugs,||
9154|083|P|nonprescription drugs, and herbal products).||
9154|084|P|   Older adults may be at greater risk for kidney problems or||
9154|085|P|hearing loss while using this drug.||
9154|086|P|   During pregnancy, this medication should be used only when||
9154|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
9154|088|P|   It is unknown if this form of vancomycin passes into breast||
9154|089|P|milk. Consult your doctor before breastfeeding.||
9154|090|B|||
9154|091|I|DRUG INTERACTIONS:  (See also How to Use section.)||
9154|092|I|   Drug interactions may change how your medications work or||
9154|093|I|increase your risk for serious side effects. This document does||
9154|094|I|not contain all possible drug interactions. Keep a list of all||
9154|095|I|the products you use (including prescription/nonprescription||
9154|096|I|drugs and herbal products) and share it with your doctor and||
9154|097|I|pharmacist. Do not start, stop, or change the dosage of any||
9154|098|I|medicines without your doctor's approval.||
9154|099|B|||
9154|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9154|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9154|102|O|poison control center right away. US residents can call||
9154|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9154|104|B|||
9154|105|N|NOTES:  Do not share this medication with others.||
9154|106|N|   This medication has been prescribed for your current condition||
9154|107|N|only. Do not use it later for another infection unless your||
9154|108|N|doctor tells you to.||
9154|109|N|   Lab and/or medical tests (such as stool samples, kidney||
9154|110|N|function, blood counts) should be done while you are taking this||
9154|111|N|medication. Keep all medical and lab appointments.||
9154|112|B|||
9154|113|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9154|114|D|remember. If it is near the time of the next dose, skip the||
9154|115|D|missed dose. Take your next dose at the regular time. Do not||
9154|116|D|double the dose to catch up.||
9154|117|B|||
9154|118|R|STORAGE:  Store at room temperature away from heat and light. Do||
9154|119|R|not store in the bathroom. Keep all medications away from||
9154|120|R|children and pets.||
9154|121|R|   Do not flush medications down the toilet or pour them into a||
9154|122|R|drain unless instructed to do so. Properly discard this product||
9154|123|R|when it is expired or no longer needed. Consult your pharmacist||
9154|124|R|or local waste disposal company.||
9154|125|B|||
9154|126|A|Information last revised August 2024.||
9154|127|A|Copyright(c) 2025 First Databank, Inc.||
9154|128|B|||
9155|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9155|002|Z|does NOT have all possible information about this product. This||
9155|003|Z|information does not assure that this product is safe, effective,||
9155|004|Z|or appropriate for you. This information is not individual||
9155|005|Z|medical advice and does not substitute for the advice of your||
9155|006|Z|health care professional. Always ask your health care||
9155|007|Z|professional for complete information about this product and your||
9155|008|Z|specific health needs.||
9155|009|B|||
9155|010|T|BUPROPION SUSTAINED-RELEASE (SMOKING DETERRENT) - ORAL||
9155|011|F|(bue-PROE-pee-on)||
9155|012|B|||
9155|013|C|COMMON BRAND NAME(S): Zyban||
9155|014|B|||
9155|015|W|WARNING:  Bupropion is an antidepressant used to treat a variety||
9155|016|W|of conditions, including depression, other mental/mood disorders,||
9155|017|W|and smoking cessation. Antidepressants can help prevent suicidal||
9155|018|W|thoughts/attempts and provide other important benefits. However,||
9155|019|W|studies have shown that a small number of people (especially||
9155|020|W|people younger than 25) who take antidepressants for any||
9155|021|W|condition may experience new or worsening depression, other||
9155|022|W|mental/mood symptoms, or suicidal thoughts/attempts. It is very||
9155|023|W|important to talk with the doctor about the risks and benefits of||
9155|024|W|antidepressant medication, even if treatment is not for a||
9155|025|W|mental/mood condition.||
9155|026|W|   Tell the doctor right away if you notice new or worsening||
9155|027|W|depression/other psychiatric conditions, unusual behavior changes||
9155|028|W|(including possible suicidal thoughts/attempts), or other||
9155|029|W|mental/mood changes (including new/worsening anxiety, panic||
9155|030|W|attacks, trouble sleeping, irritability, hostile/angry feelings,||
9155|031|W|impulsive actions, severe restlessness, very rapid speech). Be||
9155|032|W|especially watchful for these symptoms when a new antidepressant||
9155|033|W|is started or when the dose is changed.||
9155|034|W|   If you are using bupropion to quit smoking, stop taking||
9155|035|W|bupropion and contact your doctor right away if you experience||
9155|036|W|any of the symptoms listed above. Tell your doctor right away if||
9155|037|W|you have any of these symptoms after stopping treatment.||
9155|038|B|||
9155|039|U|USES:  This medication is used in combination with a stop-smoking||
9155|040|U|program (such as a support group, counseling) to help you quit||
9155|041|U|smoking. Bupropion can decrease your nicotine withdrawal symptoms||
9155|042|U|(such as irritability, anxiety, restlessness) and your urge to||
9155|043|U|smoke. Quitting smoking decreases your risk of heart and lung||
9155|044|U|disease, as well as cancer.||
9155|045|U|   This medication belongs to a class of medications known as||
9155|046|U|antidepressants. It is not known exactly how bupropion works to||
9155|047|U|reduce smoking urges. It may work by restoring the balance of||
9155|048|U|certain natural substances (dopamine, norepinephrine) in the||
9155|049|U|brain.||
9155|050|U|   Discuss the risks and benefits of this medication, as well as||
9155|051|U|other ways to quit smoking (such as nicotine replacement||
9155|052|U|treatment), with your doctor.||
9155|053|B|||
9155|054|V|OTHER USES:  This section contains uses of this drug that are not||
9155|055|V|listed in the approved professional labeling for the drug but||
9155|056|V|that may be prescribed by your health care professional. Use this||
9155|057|V|drug for a condition that is listed in this section only if it||
9155|058|V|has been so prescribed by your health care professional.||
9155|059|V|   This drug may also be used for binge eating disorder (BED) or||
9155|060|V|mental/mood disorders (such as depression, attention deficit||
9155|061|V|hyperactivity disorder-ADHD, seasonal affective disorder,||
9155|062|V|depressive phase of bipolar disorder).||
9155|063|B|||
9155|064|H|HOW TO USE:  Read the Medication Guide and, if available, the||
9155|065|H|Patient Information Leaflet provided by your pharmacist before||
9155|066|H|you start using bupropion and each time you get a refill. If you||
9155|067|H|have any questions, ask your doctor or pharmacist.||
9155|068|H|   Take this medication by mouth with or without food as directed||
9155|069|H|by your doctor, usually twice daily. If stomach upset occurs,||
9155|070|H|take with food. It is important to take your doses at least 8||
9155|071|H|hours apart or as directed by your doctor to decrease your risk||
9155|072|H|of seizure.||
9155|073|H|   You may have trouble sleeping when you start taking this drug.||
9155|074|H|Do not take your evening dose too close to bedtime.||
9155|075|H|   Swallow the tablets whole. Do not crush or chew the tablets.||
9155|076|H|Doing so can release all of the drug at once, increasing the risk||
9155|077|H|of side effects.||
9155|078|H|   The dosage is based on your medical condition and response to||
9155|079|H|treatment. Your dose may be slowly increased to limit side||
9155|080|H|effects. Do not take more or less medication or take it more||
9155|081|H|often than prescribed. Taking more than the recommended dose of||
9155|082|H|bupropion may increase your risk of having a seizure.||
9155|083|H|   It is recommended that you do not try to quit smoking until||
9155|084|H|you have been taking bupropion for 1 week so that the drug can||
9155|085|H|reach a high enough level in your blood. Set a date for quitting,||
9155|086|H|and stop smoking sometime in the second week of taking the drug.||
9155|087|H|   If necessary, this medication may be combined with nicotine||
9155|088|H|patches or gum to help you quit smoking. Ask your doctor for more||
9155|089|H|information. The combination of nicotine and this medication may||
9155|090|H|increase your blood pressure. Your doctor may need to monitor||
9155|091|H|your blood pressure closely. Do not smoke at any time if using||
9155|092|H|any nicotine products with this drug. Too much nicotine can cause||
9155|093|H|serious side effects.||
9155|094|H|   Use this medication regularly in order to get the most benefit||
9155|095|H|from it. To help you remember, use it at the same times each day.||
9155|096|H|   Tell your doctor if you are not able to stop smoking after 7||
9155|097|H|to 12 weeks on this medication.||
9155|098|B|||
9155|099|S|SIDE EFFECTS:  See also Warning section.||
9155|100|S|   Dry mouth and trouble sleeping may occur as your body gets||
9155|101|S|used to the drug. Dizziness, drowsiness, nausea, diarrhea,||
9155|102|S|tiredness, constipation, blurred vision, increased sweating,||
9155|103|S|strange taste in mouth, or stomach pain may also occur. If any of||
9155|104|S|these effects last or get worse, tell your doctor or pharmacist||
9155|105|S|promptly.||
9155|106|S|   Remember that this medication has been prescribed because your||
9155|107|S|doctor has judged that the benefit to you is greater than the||
9155|108|S|risk of side effects. Many people using this medication do not||
9155|109|S|have serious side effects.||
9155|110|S|   This medication may raise your blood pressure. Check your||
9155|111|S|blood pressure regularly and tell your doctor if the results are||
9155|112|S|high.||
9155|113|S|   Tell your doctor right away if you have any serious side||
9155|114|S|effects, including: chest pain, fainting, fast/pounding||
9155|115|S|heartbeat, irregular heartbeat, mental/mood changes (such as||
9155|116|S|anxiety, agitation, confusion, memory loss), muscle aches,||
9155|117|S|ringing in the ears, severe headache, uncontrolled movements||
9155|118|S|(tremor), unusual weight loss or gain, muscle||
9155|119|S|pain/tenderness/weakness.||
9155|120|S|   Get medical help right away if you have any very serious side||
9155|121|S|effects, including: eye pain/swelling/redness, widened pupils,||
9155|122|S|vision changes (such as seeing rainbows around lights at night),||
9155|123|S|seizure.||
9155|124|S|   A very serious allergic reaction to this drug is rare.||
9155|125|S|However, get medical help right away if you notice any symptoms||
9155|126|S|of a serious allergic reaction, including: rash, itching/swelling||
9155|127|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9155|128|S|breathing.||
9155|129|S|   An empty tablet shell may appear in your stool. This is||
9155|130|S|harmless.||
9155|131|S|   This is not a complete list of possible side effects. If you||
9155|132|S|notice other effects not listed above, contact your doctor or||
9155|133|S|pharmacist.||
9155|134|S|   In the US -||
9155|135|S|   Call your doctor for medical advice about side effects. You||
9155|136|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9155|137|S|www.fda.gov/medwatch.||
9155|138|S|   In Canada - Call your doctor for medical advice about side||
9155|139|S|effects. You may report side effects to Health Canada at||
9155|140|S|1-866-234-2345.||
9155|141|B|||
9155|142|P|PRECAUTIONS:  Before taking bupropion, tell your doctor or||
9155|143|P|pharmacist if you are allergic to it; or if you have any other||
9155|144|P|allergies. This product may contain inactive ingredients, which||
9155|145|P|can cause allergic reactions or other problems. Talk to your||
9155|146|P|pharmacist for more details.||
9155|147|P|   Before using this medication, tell your doctor or pharmacist||
9155|148|P|your medical history, especially of: seizures or conditions that||
9155|149|P|increase your risk of seizures (including brain/head injury,||
9155|150|P|brain tumors, arteriovenous malformation, eating disorders such||
9155|151|P|as bulimia/anorexia nervosa), alcohol/drug dependence, diabetes,||
9155|152|P|heart disease (such as heart failure, recent heart attack), high||
9155|153|P|blood pressure, kidney problems, liver problems (such as||
9155|154|P|cirrhosis), mental/mood disorders (such as bipolar disorder,||
9155|155|P|thoughts of suicide), personal or family history of glaucoma||
9155|156|P|(angle-closure type).||
9155|157|P|   This medication should not be used if you are suddenly||
9155|158|P|stopping regular use of sedatives (including benzodiazepines such||
9155|159|P|as lorazepam), drugs used to treat seizures, or alcohol. Doing so||
9155|160|P|may increase your risk of seizures.||
9155|161|P|   This drug may make you dizzy or drowsy or blur your vision.||
9155|162|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9155|163|P|drowsy. Do not drive, use machinery, or do anything that needs||
9155|164|P|alertness or clear vision until you can do it safely. Avoid||
9155|165|P|alcoholic beverages. Talk to your doctor if you are using||
9155|166|P|marijuana (cannabis). Alcohol may also increase your risk of||
9155|167|P|seizures.||
9155|168|P|   Before having surgery, tell your doctor or dentist about all||
9155|169|P|the products you use (including prescription drugs,||
9155|170|P|nonprescription drugs, and herbal products).||
9155|171|P|   Older adults may be more sensitive to the side effects of this||
9155|172|P|drug, especially dizziness and memory loss. Dizziness can||
9155|173|P|increase the risk of falling.||
9155|174|P|   During pregnancy, this medication should be used only when||
9155|175|P|clearly needed. Behavioral therapy and stop-smoking education is||
9155|176|P|preferred for pregnant women who desire to stop smoking. Discuss||
9155|177|P|the risks and benefits with your doctor.||
9155|178|P|   This drug passes into breast milk and may have undesirable||
9155|179|P|effects on a nursing infant. Consult your doctor before||
9155|180|P|breastfeeding.||
9155|181|B|||
9155|182|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9155|183|I|medications work or increase your risk for serious side effects.||
9155|184|I|This document does not contain all possible drug interactions.||
9155|185|I|Keep a list of all the products you use (including||
9155|186|I|prescription/nonprescription drugs and herbal products) and share||
9155|187|I|it with your doctor and pharmacist. Do not start, stop, or change||
9155|188|I|the dosage of any medicines without your doctor's approval.||
9155|189|I|   Some products that may interact with this drug include:||
9155|190|I|codeine, pimozide, tamoxifen, thioridazine.||
9155|191|I|   Taking MAO inhibitors with this medication may cause a serious||
9155|192|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9155|193|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9155|194|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9155|195|I|selegiline, tranylcypromine) during treatment with this||
9155|196|I|medication. Most MAO inhibitors should also not be taken for two||
9155|197|I|weeks before and after treatment with this medication. Ask your||
9155|198|I|doctor when to start or stop taking this medication.||
9155|199|I|   This medication may interfere with certain medical/lab tests||
9155|200|I|(such as brain scan for Parkinson's disease, urine screening for||
9155|201|I|amphetamines), possibly causing false test results. Make sure lab||
9155|202|I|personnel and all your doctors know you use this drug.||
9155|203|B|||
9155|204|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9155|205|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9155|206|O|poison control center right away. US residents can call||
9155|207|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9155|208|O|Symptoms of overdose may include: seizures, severe confusion,||
9155|209|O|hallucinations, rapid heart rate, and loss of consciousness.||
9155|210|B|||
9155|211|N|NOTES:  Do not share this medication with others.||
9155|212|N|   Lab and/or medical tests (such as blood pressure monitoring,||
9155|213|N|liver function) may be done while you are taking this medication.||
9155|214|N|Keep all medical and lab appointments. Consult your doctor for||
9155|215|N|more details.||
9155|216|B|||
9155|217|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
9155|218|D|next dose at the regular time. Do not double the dose to catch||
9155|219|D|up.||
9155|220|B|||
9155|221|R|STORAGE:  Store at room temperature away from light and moisture.||
9155|222|R|Bupropion tablets may have a strange odor. This is normal, and||
9155|223|R|the medication is still safe to use. Do not store in the||
9155|224|R|bathroom. Keep all medications away from children and pets.||
9155|225|R|   Do not flush medications down the toilet or pour them into a||
9155|226|R|drain unless instructed to do so. Properly discard this product||
9155|227|R|when it is expired or no longer needed. Consult your pharmacist||
9155|228|R|or local waste disposal company.||
9155|229|B|||
9155|230|A|Information last revised May 2024.||
9155|231|A|Copyright(c) 2025 First Databank, Inc.||
9155|232|B|||
9157|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9157|002|Z|does NOT have all possible information about this product. This||
9157|003|Z|information does not assure that this product is safe, effective,||
9157|004|Z|or appropriate for you. This information is not individual||
9157|005|Z|medical advice and does not substitute for the advice of your||
9157|006|Z|health care professional. Always ask your health care||
9157|007|Z|professional for complete information about this product and your||
9157|008|Z|specific health needs.||
9157|009|B|||
9157|010|T|BCG - INTRAVESICAL||
9157|011|B|||
9157|012|C|COMMON BRAND NAME(S): Theracys||
9157|013|B|||
9157|014|W|WARNING:  This medication contains live bacteria that have been||
9157|015|W|weakened to decrease the chances of causing an illness. However,||
9157|016|W|this medication has rarely caused very serious, possibly fatal||
9157|017|W|infections. Tell your doctor right away if you develop any signs||
9157|018|W|of infection (such as fever that doesn't go away, chills).||
9157|019|B|||
9157|020|U|USES:  This medication is used to treat or prevent certain types||
9157|021|U|of bladder cancer. This medication works by causing the body's||
9157|022|U|defense system (immune system) to become more active.||
9157|023|U|   This form of the medication is not used to prevent||
9157|024|U|tuberculosis.||
9157|025|B|||
9157|026|H|HOW TO USE:  This medication is given into the bladder through a||
9157|027|H|tube (catheter) by a health care professional as directed by your||
9157|028|H|doctor. This medication is usually given weekly for the first 6||
9157|029|H|weeks and then less often thereafter as directed by your doctor.||
9157|030|H|   Do not drink any fluids for 4 hours before treatment. The||
9157|031|H|medication is left in the bladder for up to 2 hours and then||
9157|032|H|released by urinating. Follow your doctor's instructions||
9157|033|H|carefully. There may be some burning pain when you first urinate.||
9157|034|H|Since the urine contains live bacteria that may infect you or||
9157|035|H|others, you must sit down to urinate for 6 hours after treatment||
9157|036|H|to avoid splashing of the urine. After each time you urinate||
9157|037|H|during this 6-hour period, pour household bleach (about the same||
9157|038|H|amount of bleach as the amount of urine) into the toilet, then||
9157|039|H|wait 15 minutes before flushing. Always wash your hands||
9157|040|H|afterward. Talk to your doctor about other important things you||
9157|041|H|must do to prevent infection.||
9157|042|H|   Drink plenty of fluids after your first urination unless||
9157|043|H|otherwise directed by your doctor. Doing so helps clear the||
9157|044|H|medication from your body.||
9157|045|B|||
9157|046|S|SIDE EFFECTS:  See also Warning section.||
9157|047|S|   Nausea, vomiting, loss of appetite, or diarrhea may occur. If||
9157|048|S|any of these effects last or get worse, tell your doctor or||
9157|049|S|pharmacist promptly.||
9157|050|S|   Remember that this medication has been prescribed because your||
9157|051|S|doctor has judged that the benefit to you is greater than the||
9157|052|S|risk of side effects. Many people using this medication do not||
9157|053|S|have serious side effects.||
9157|054|S|   Tell your doctor right away if you have any serious side||
9157|055|S|effects, including: signs of bladder irritation (such as||
9157|056|S|difficult/painful/frequent/bloody urination), muscle/joint pain,||
9157|057|S|pain/swelling of the testes, unusual tiredness, fast/pounding||
9157|058|S|heartbeat, shortness of breath, vision changes,||
9157|059|S|redness/swelling/pain in the eye, eye sensitivity to light,||
9157|060|S|severe stomach/abdominal pain, yellowing skin/eyes.||
9157|061|S|   A very serious allergic reaction to this drug is rare.||
9157|062|S|However, get medical help right away if you notice any symptoms||
9157|063|S|of a serious allergic reaction, including: rash, itching/swelling||
9157|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9157|065|S|breathing.||
9157|066|S|   This is not a complete list of possible side effects. If you||
9157|067|S|notice other effects not listed above, contact your doctor or||
9157|068|S|pharmacist.||
9157|069|S|   In the US -||
9157|070|S|   Call your doctor for medical advice about side effects. You||
9157|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9157|072|S|www.fda.gov/medwatch.||
9157|073|S|   In Canada - Call your doctor for medical advice about side||
9157|074|S|effects. You may report side effects to Health Canada at||
9157|075|S|1-866-234-2345.||
9157|076|B|||
9157|077|P|PRECAUTIONS:  Before receiving this medication, tell your doctor||
9157|078|P|or pharmacist if you are allergic to it; or if you have any other||
9157|079|P|allergies. This product may contain inactive ingredients (such as||
9157|080|P|latex), which can cause allergic reactions or other problems.||
9157|081|P|Talk to your pharmacist for more details.||
9157|082|P|   Before using this medication, tell your doctor or pharmacist||
9157|083|P|your medical history, especially of: immune system problems||
9157|084|P|(including HIV, certain cancers such as leukemia/lymphoma),||
9157|085|P|radiation treatment, current infection/fever (such as bladder||
9157|086|P|infection, active tuberculosis), certain blood vessel disease||
9157|087|P|(aneurysm), injury/procedure in the bladder within the last 7||
9157|088|P|days (such as catheterization, biopsy, signs of bloody urine),||
9157|089|P|man-made medical devices/parts in the body (such as pacemakers,||
9157|090|P|artificial joints, arterial grafts).||
9157|091|P|   During pregnancy, this medication should be used only when||
9157|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
9157|093|P|It is recommended that women receiving this medication avoid||
9157|094|P|pregnancy. Discuss the use of reliable forms of birth control||
9157|095|P|(such as condoms, birth control pills) with your doctor. If you||
9157|096|P|become pregnant or think you may be pregnant, tell your doctor||
9157|097|P|right away.||
9157|098|P|   It is unknown if this drug passes into breast milk. Because of||
9157|099|P|the possible risk to the infant, breastfeeding is not recommended||
9157|100|P|while using this drug. Consult your doctor before breastfeeding.||
9157|101|B|||
9157|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9157|103|I|medications work or increase your risk for serious side effects.||
9157|104|I|This document does not contain all possible drug interactions.||
9157|105|I|Keep a list of all the products you use (including||
9157|106|I|prescription/nonprescription drugs and herbal products) and share||
9157|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
9157|108|I|the dosage of any medicines without your doctor's approval.||
9157|109|I|   Some products that may interact with this drug are:||
9157|110|I|antibiotics (including isoniazid, rifampin, penicillins such as||
9157|111|I|amoxicillin, macrolides such as erythromycin), drugs that weaken||
9157|112|I|the immune system (including abatacept, corticosteroids such as||
9157|113|I|prednisone, cancer chemotherapy), mefloquine.||
9157|114|I|   This medication may interfere with the tuberculosis (TB) skin||
9157|115|I|test, possibly causing false test results. If a skin test is||
9157|116|I|needed, it is recommended that patients finish it before||
9157|117|I|treatment.||
9157|118|B|||
9157|119|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9157|120|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9157|121|O|poison control center right away. US residents can call||
9157|122|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9157|123|B|||
9157|124|N|NOTES:  Keep all medical and lab appointments.||
9157|125|B|||
9157|126|D|MISSED DOSE:  It is important to get each dose of this medication||
9157|127|D|as scheduled. If you miss a dose, ask your doctor right away for||
9157|128|D|a new dosing schedule.||
9157|129|B|||
9157|130|R|STORAGE:  Not applicable. This medication is given in a hospital||
9157|131|R|or clinic and will not be stored at home.||
9157|132|B|||
9157|133|A|Information last revised May 2025.||
9157|134|A|Copyright(c) 2025 First Databank, Inc.||
9157|135|B|||
9159|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9159|002|Z|does NOT have all possible information about this product. This||
9159|003|Z|information does not assure that this product is safe, effective,||
9159|004|Z|or appropriate for you. This information is not individual||
9159|005|Z|medical advice and does not substitute for the advice of your||
9159|006|Z|health care professional. Always ask your health care||
9159|007|Z|professional for complete information about this product and your||
9159|008|Z|specific health needs.||
9159|009|B|||
9159|010|T|ANAGRELIDE - ORAL||
9159|011|F|(an-AG-re-lide)||
9159|012|B|||
9159|013|C|COMMON BRAND NAME(S): Agrylin||
9159|014|B|||
9159|015|U|USES:  Anagrelide is used to treat a certain blood disorder||
9159|016|U|(thrombocythemia), which is caused by your bone marrow making too||
9159|017|U|many platelets. Platelets are a blood cell that the body uses to||
9159|018|U|form blood clots. Too many platelets can cause problems with your||
9159|019|U|circulation, including unwanted blood clots and bleeding||
9159|020|U|problems. This drug reduces the number of platelets in the||
9159|021|U|bloodstream by blocking their production.||
9159|022|B|||
9159|023|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9159|024|H|from your pharmacist before you start taking anagrelide and each||
9159|025|H|time you get a refill. If you have any questions, ask your doctor||
9159|026|H|or pharmacist.||
9159|027|H|   Take this medication by mouth with or without food as directed||
9159|028|H|by your doctor, usually 2 or 4 times a day. Children or people||
9159|029|H|with liver problems may start out by taking only 1 dose each day.||
9159|030|H|Your doctor will adjust your dose, usually once a week, to find||
9159|031|H|the best dose for you that keeps your blood counts closer to||
9159|032|H|normal. The dosage is based on your medical condition and||
9159|033|H|response to treatment.||
9159|034|H|   Use this medication regularly in order to get the most benefit||
9159|035|H|from it. To help you remember, take it at the same times each||
9159|036|H|day. Keep taking this medication even if you feel well. People||
9159|037|H|with high platelets may not feel sick. Do not stop taking this||
9159|038|H|medication without consulting your doctor. Stopping anagrelide||
9159|039|H|will cause your platelets to go back up.||
9159|040|H|   Your doctor will check your blood counts regularly to monitor||
9159|041|H|your progress and adjust your dose.||
9159|042|B|||
9159|043|S|SIDE EFFECTS:  Headache, diarrhea, weakness, nausea, gas, loss of||
9159|044|S|appetite, and dizziness may occur. If any of these effects last||
9159|045|S|or get worse, tell your doctor or pharmacist promptly.||
9159|046|S|   To reduce the risk of dizziness and lightheadedness, get up||
9159|047|S|slowly when rising from a sitting or lying position.||
9159|048|S|   Remember that this medication has been prescribed because your||
9159|049|S|doctor has judged that the benefit to you is greater than the||
9159|050|S|risk of side effects. Many people using this medication do not||
9159|051|S|have serious side effects.||
9159|052|S|   Tell your doctor right away if you have any serious side||
9159|053|S|effects, including: unusual bleeding/bruising, black stools,||
9159|054|S|swelling of the ankles/feet, rapid/difficult breathing,||
9159|055|S|stomach/abdominal pain, unusual tiredness, signs of kidney||
9159|056|S|problems (such as change in the amount of urine, pink/bloody||
9159|057|S|urine), vomit that looks like coffee grounds.||
9159|058|S|   Get medical help right away if you have any very serious side||
9159|059|S|effects, including: chest/jaw/left arm pain, confusion/mental||
9159|060|S|changes, severe dizziness, fainting, fast/irregular/pounding||
9159|061|S|heartbeat, seizures, trouble speaking, vision changes, weakness||
9159|062|S|on one side of the body.||
9159|063|S|   A very serious allergic reaction to this drug is rare.||
9159|064|S|However, get medical help right away if you notice any symptoms||
9159|065|S|of a serious allergic reaction, including: rash, itching/swelling||
9159|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9159|067|S|breathing.||
9159|068|S|   This is not a complete list of possible side effects. If you||
9159|069|S|notice other effects not listed above, contact your doctor or||
9159|070|S|pharmacist.||
9159|071|S|   In the US -||
9159|072|S|   Call your doctor for medical advice about side effects. You||
9159|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9159|074|S|www.fda.gov/medwatch.||
9159|075|S|   In Canada - Call your doctor for medical advice about side||
9159|076|S|effects. You may report side effects to Health Canada at||
9159|077|S|1-866-234-2345.||
9159|078|B|||
9159|079|P|PRECAUTIONS:  Before taking anagrelide, tell your doctor or||
9159|080|P|pharmacist if you are allergic to it; or if you have any other||
9159|081|P|allergies. This product may contain inactive ingredients, which||
9159|082|P|can cause allergic reactions or other problems. Talk to your||
9159|083|P|pharmacist for more details.||
9159|084|P|   Before using this medication, tell your doctor or pharmacist||
9159|085|P|your medical history, especially of: heart problems (such as||
9159|086|P|heart attack, irregular heartbeat), lung problems, kidney||
9159|087|P|problems, liver problems.||
9159|088|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9159|089|P|can make you more dizzy. Do not drive, use machinery, or do||
9159|090|P|anything that needs alertness until you can do it safely. Limit||
9159|091|P|alcoholic beverages. Talk to your doctor if you are using||
9159|092|P|marijuana (cannabis).||
9159|093|P|   Anagrelide may cause a condition that affects the heart rhythm||
9159|094|P|(QT prolongation). QT prolongation can rarely cause serious||
9159|095|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
9159|096|P|as severe dizziness, fainting) that need medical attention right||
9159|097|P|away.||
9159|098|P|   The risk of QT prolongation may be increased if you have||
9159|099|P|certain medical conditions or are taking other drugs that may||
9159|100|P|cause QT prolongation. Before using anagrelide, tell your doctor||
9159|101|P|or pharmacist of all the drugs you take and if you have any of||
9159|102|P|the following conditions: certain heart problems (heart failure,||
9159|103|P|slow heartbeat, QT prolongation in the EKG), family history of||
9159|104|P|certain heart problems (QT prolongation in the EKG, sudden||
9159|105|P|cardiac death).||
9159|106|P|   Low levels of potassium or magnesium in the blood may also||
9159|107|P|increase your risk of QT prolongation. This risk may increase if||
9159|108|P|you use certain drugs (such as diuretics/"water pills") or if you||
9159|109|P|have conditions such as severe sweating, diarrhea, or vomiting.||
9159|110|P|Talk to your doctor about using anagrelide safely.||
9159|111|P|   Before having surgery, tell your doctor or dentist about all||
9159|112|P|the products you use (including prescription drugs,||
9159|113|P|nonprescription drugs, and herbal products).||
9159|114|P|   Older adults may be more sensitive to the side effects of this||
9159|115|P|drug, especially QT prolongation (see above).||
9159|116|P|   During pregnancy, this medication should be used only when||
9159|117|P|clearly needed. Discuss the risks and benefits with your doctor.||
9159|118|P|   It is unknown if this medication passes into breast milk.||
9159|119|P|Because of the possible risk to the infant, breastfeeding is not||
9159|120|P|recommended while using this medication and for 1 week after the||
9159|121|P|last dose. Consult your doctor before breastfeeding.||
9159|122|B|||
9159|123|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9159|124|I|medications work or increase your risk for serious side effects.||
9159|125|I|This document does not contain all possible drug interactions.||
9159|126|I|Keep a list of all the products you use (including||
9159|127|I|prescription/nonprescription drugs and herbal products) and share||
9159|128|I|it with your doctor and pharmacist. Do not start, stop, or change||
9159|129|I|the dosage of any medicines without your doctor's approval.||
9159|130|I|   Some products that may interact with this drug include: other||
9159|131|I|drugs that can cause bleeding/bruising (including antiplatelet||
9159|132|I|drugs such as clopidogrel, "blood thinners" such as||
9159|133|I|warfarin/enoxaparin), sucralfate.||
9159|134|I|   Aspirin can increase the risk of bleeding when used with this||
9159|135|I|medication. However, if your doctor has told you to take low-dose||
9159|136|I|aspirin to prevent blood clots, heart attack, or stroke (usually||
9159|137|I|81-162 milligrams a day), you should keep taking the aspirin||
9159|138|I|unless your doctor tells you not to. Ask your doctor or||
9159|139|I|pharmacist for more details.||
9159|140|I|   Many drugs besides anagrelide may affect the heart rhythm (QT||
9159|141|I|prolongation), including amiodarone, chloroquine, clarithromycin,||
9159|142|I|disopyramide, haloperidol, methadone, moxifloxacin, pimozide,||
9159|143|I|procainamide, among others.||
9159|144|B|||
9159|145|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9159|146|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9159|147|O|poison control center right away. US residents can call||
9159|148|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9159|149|O|Symptoms of overdose may include: unusual bleeding/bruising, fast||
9159|150|O|heartbeat, vomiting.||
9159|151|B|||
9159|152|N|NOTES:  Do not share this medication with others.||
9159|153|N|   Lab and/or medical tests (such as heart exam, EKG, complete||
9159|154|N|blood counts, kidney/liver function) should be done before you||
9159|155|N|start taking this medication and while you are taking it. Keep||
9159|156|N|all medical and lab appointments. Consult your doctor for more||
9159|157|N|details.||
9159|158|B|||
9159|159|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9159|160|D|remember. If it is near the time of the next dose, skip the||
9159|161|D|missed dose. Take your next dose at the regular time. Do not||
9159|162|D|double the dose to catch up.||
9159|163|B|||
9159|164|R|STORAGE:  Store at room temperature away from light and moisture.||
9159|165|R|Keep all medications away from children and pets.||
9159|166|R|   Do not flush medications down the toilet or pour them into a||
9159|167|R|drain unless instructed to do so. Properly discard this product||
9159|168|R|when it is expired or no longer needed. Consult your pharmacist||
9159|169|R|or local waste disposal company.||
9159|170|B|||
9159|171|M|MEDICAL ALERT:  Your condition can cause complications in a||
9159|172|M|medical emergency. For information about enrolling in MedicAlert,||
9159|173|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9159|174|B|||
9159|175|A|Information last revised May 2024.||
9159|176|A|Copyright(c) 2025 First Databank, Inc.||
9159|177|B|||
9162|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9162|002|Z|does NOT have all possible information about this product. This||
9162|003|Z|information does not assure that this product is safe, effective,||
9162|004|Z|or appropriate for you. This information is not individual||
9162|005|Z|medical advice and does not substitute for the advice of your||
9162|006|Z|health care professional. Always ask your health care||
9162|007|Z|professional for complete information about this product and your||
9162|008|Z|specific health needs.||
9162|009|B|||
9162|010|T|TRIPTORELIN 1 MONTH (3.75 MG) - INJECTION||
9162|011|F|(trip-toe-REL-in)||
9162|012|B|||
9162|013|C|COMMON BRAND NAME(S): Trelstar Depot||
9162|014|B|||
9162|015|U|USES:  Triptorelin is used to treat advanced prostate cancer. It||
9162|016|U|is not a cure. Most types of prostate cancer need the hormone||
9162|017|U|testosterone to grow and spread. Triptorelin works by reducing||
9162|018|U|the amount of testosterone that the body makes. This effect helps||
9162|019|U|slow or stop the growth of cancer cells and helps relieve||
9162|020|U|symptoms such as painful/difficult urination. This medication is||
9162|021|U|similar to a natural substance made by the body (luteinizing||
9162|022|U|hormone releasing hormone-LHRH). Talk to your doctor about the||
9162|023|U|risks and benefits of treatment.||
9162|024|B|||
9162|025|V|OTHER USES:  This section contains uses of this drug that are not||
9162|026|V|listed in the approved professional labeling for the drug but||
9162|027|V|that may be prescribed by your health care professional. Use this||
9162|028|V|drug for a condition that is listed in this section only if it||
9162|029|V|has been so prescribed by your health care professional.||
9162|030|V|   This drug may also be used for a certain disorder of the||
9162|031|V|uterus (endometriosis). Triptorelin may also be used to stop||
9162|032|V|early puberty in children.||
9162|033|B|||
9162|034|H|HOW TO USE:  This medication is given as an injection into the||
9162|035|H|muscle of your buttocks by a health care professional. It is||
9162|036|H|given as directed by your doctor, usually once every month (4||
9162|037|H|weeks).||
9162|038|H|   Follow the dosing schedule carefully to get the most benefit||
9162|039|H|from this drug. To help you remember, mark your calendar with a||
9162|040|H|reminder.||
9162|041|H|   During the first few weeks of treatment, your testosterone||
9162|042|H|level will actually increase before it decreases. This is a||
9162|043|H|normal response by your body to this drug. This effect may result||
9162|044|H|in new or worsening symptoms for the first few weeks. If you have||
9162|045|H|prostate cancer that has spread to the spine or that has caused||
9162|046|H|urinary blockage, you may require closer monitoring by your||
9162|047|H|doctor, especially when you first start treatment. Tell your||
9162|048|H|doctor right away if you experience any of the following serious||
9162|049|H|side effects: bone pain, numbness/tingling/weakness of the||
9162|050|H|arms/legs, blood in the urine, painful/difficult urination.||
9162|051|H|   Tell your doctor if your condition does not get better or if||
9162|052|H|it gets worse.||
9162|053|B|||
9162|054|S|SIDE EFFECTS:  See also the How to Use section.||
9162|055|S|   Hot flashes (flushing), decreased sexual interest/ability,||
9162|056|S|shrinking of the testicles, and breast tenderness/swelling may||
9162|057|S|occur as a result of lowered testosterone levels. Dizziness and||
9162|058|S|headache may also occur with this drug. If any of these effects||
9162|059|S|bother you, tell your doctor or pharmacist promptly.||
9162|060|S|   Remember that this medication has been prescribed because your||
9162|061|S|doctor has judged that the benefit to you is greater than the||
9162|062|S|risk of side effects. Many people using this medication do not||
9162|063|S|have serious side effects.||
9162|064|S|   Tell your doctor right away if you have any serious side||
9162|065|S|effects, including: bone/joint/unusual pain, easily broken bones,||
9162|066|S|swelling of the ankles/feet, unusual weakness, inability to move||
9162|067|S|(paralysis), increased thirst, increased urination, mental/mood||
9162|068|S|changes (such as depression), signs of liver disease (such as||
9162|069|S|nausea/vomiting that doesn't stop, loss of appetite,||
9162|070|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
9162|071|S|   Get medical help right away if you have any very serious side||
9162|072|S|effects, including: chest/jaw/left arm pain, fast/irregular||
9162|073|S|heartbeat, severe dizziness, fainting, weakness on one side of||
9162|074|S|the body, trouble speaking, seizures.||
9162|075|S|   A very serious allergic reaction to this drug is rare.||
9162|076|S|However, get medical help right away if you notice any symptoms||
9162|077|S|of a serious allergic reaction, including: fever, swollen lymph||
9162|078|S|nodes, rash, itching/swelling (especially of the||
9162|079|S|face/tongue/throat), severe dizziness, trouble breathing.||
9162|080|S|   This is not a complete list of possible side effects. If you||
9162|081|S|notice other effects not listed above, contact your doctor or||
9162|082|S|pharmacist.||
9162|083|S|   In the US -||
9162|084|S|   Call your doctor for medical advice about side effects. You||
9162|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9162|086|S|www.fda.gov/medwatch.||
9162|087|S|   In Canada - Call your doctor for medical advice about side||
9162|088|S|effects. You may report side effects to Health Canada at||
9162|089|S|1-866-234-2345.||
9162|090|B|||
9162|091|P|PRECAUTIONS:  Before using triptorelin, tell your doctor or||
9162|092|P|pharmacist if you are allergic to it; or to other LHRH-type drugs||
9162|093|P|(such as leuprolide); or if you have any other allergies. This||
9162|094|P|product may contain inactive ingredients, which can cause||
9162|095|P|allergic reactions or other problems. Talk to your pharmacist for||
9162|096|P|more details.||
9162|097|P|   Before using this medication, tell your doctor or pharmacist||
9162|098|P|your medical history, especially of: kidney disease, liver||
9162|099|P|disease, personal or family history of weak/broken bones||
9162|100|P|(osteoporosis), diabetes, heart disease (such as heart attack),||
9162|101|P|stroke, high cholesterol, mental/mood problems (such as||
9162|102|P|depression), seizures.||
9162|103|P|   Triptorelin may cause a condition that affects the heart||
9162|104|P|rhythm (QT prolongation). QT prolongation can rarely cause||
9162|105|P|serious (rarely fatal) fast/irregular heartbeat and other||
9162|106|P|symptoms (such as severe dizziness, fainting) that need medical||
9162|107|P|attention right away.||
9162|108|P|   The risk of QT prolongation may be increased if you have||
9162|109|P|certain medical conditions or are taking other drugs that may||
9162|110|P|cause QT prolongation. Before using triptorelin, tell your doctor||
9162|111|P|or pharmacist of all the drugs you take and if you have any of||
9162|112|P|the following conditions: certain heart problems (heart failure,||
9162|113|P|slow heartbeat, QT prolongation in the EKG), family history of||
9162|114|P|certain heart problems (QT prolongation in the EKG, sudden||
9162|115|P|cardiac death).||
9162|116|P|   Low levels of potassium or magnesium in the blood may also||
9162|117|P|increase your risk of QT prolongation. This risk may increase if||
9162|118|P|you use certain drugs (such as diuretics/"water pills") or if you||
9162|119|P|have conditions such as severe sweating, diarrhea, or vomiting.||
9162|120|P|Talk to your doctor about using triptorelin safely.||
9162|121|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9162|122|P|can make you more dizzy. Do not drive, use machinery, or do||
9162|123|P|anything that needs alertness until you can do it safely. Limit||
9162|124|P|alcoholic beverages. Talk to your doctor if you are using||
9162|125|P|marijuana (cannabis).||
9162|126|P|   Older adults may be more sensitive to the side effects of this||
9162|127|P|drug, especially QT prolongation (see above).||
9162|128|P|   Females: Triptorelin is not usually used by women. It must not||
9162|129|P|be used by pregnant women because it may harm an unborn baby. If||
9162|130|P|you become pregnant or think you may be pregnant, tell your||
9162|131|P|doctor right away. Breastfeeding is also not recommended during||
9162|132|P|triptorelin treatment. Consult your doctor for more details and||
9162|133|P|before breastfeeding, and to discuss reliable forms of birth||
9162|134|P|control.||
9162|135|B|||
9162|136|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9162|137|I|medications work or increase your risk for serious side effects.||
9162|138|I|This document does not contain all possible drug interactions.||
9162|139|I|Keep a list of all the products you use (including||
9162|140|I|prescription/nonprescription drugs and herbal products) and share||
9162|141|I|it with your doctor and pharmacist. Do not start, stop, or change||
9162|142|I|the dosage of any medicines without your doctor's approval.||
9162|143|B|||
9162|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9162|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9162|146|O|poison control center right away. US residents can call||
9162|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9162|148|B|||
9162|149|N|NOTES:  Lab and/or medical tests (such as testosterone blood||
9162|150|N|levels, PSA blood tests, blood glucose, cholesterol/triglyceride||
9162|151|N|levels) should be done while you are using this medication. Keep||
9162|152|N|all medical and lab appointments. Consult your doctor for more||
9162|153|N|details.||
9162|154|B|||
9162|155|D|MISSED DOSE:  It is important to get each dose of this medication||
9162|156|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9162|157|D|right away for a new dosing schedule.||
9162|158|B|||
9162|159|R|STORAGE:  Not applicable. This medication is given in a doctor's||
9162|160|R|office and will not be stored at home.||
9162|161|B|||
9162|162|A|Information last revised September 2025.||
9162|163|A|Copyright(c) 2025 First Databank, Inc.||
9162|164|B|||
9167|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9167|002|Z|does NOT have all possible information about this product. This||
9167|003|Z|information does not assure that this product is safe, effective,||
9167|004|Z|or appropriate for you. This information is not individual||
9167|005|Z|medical advice and does not substitute for the advice of your||
9167|006|Z|health care professional. Always ask your health care||
9167|007|Z|professional for complete information about this product and your||
9167|008|Z|specific health needs.||
9167|009|B|||
9167|010|T|FINASTERIDE (HAIR GROWTH) - ORAL||
9167|011|F|(fin-AST-er-ide)||
9167|012|B|||
9167|013|C|COMMON BRAND NAME(S): Propecia||
9167|014|B|||
9167|015|U|USES:  This medication is used to treat male pattern baldness||
9167|016|U|(androgenetic alopecia) at the crown and in the middle of the||
9167|017|U|scalp. It should be used by adult men only.||
9167|018|U|   This medication works by decreasing the amount of a natural||
9167|019|U|body hormone (DHT). Decreasing the amount of DHT leads to||
9167|020|U|increased hair regrowth and slower hair loss. Hair growth on||
9167|021|U|other parts of the body is not affected by finasteride.||
9167|022|U|   Women and children should not use this medication.||
9167|023|B|||
9167|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9167|025|H|from your pharmacist before you start taking finasteride and each||
9167|026|H|time you get a refill. If you have any questions, ask your doctor||
9167|027|H|or pharmacist.||
9167|028|H|   Take this medication by mouth with or without food as directed||
9167|029|H|by your doctor, usually once a day.||
9167|030|H|   Since this drug can be absorbed through the skin and lungs and||
9167|031|H|may harm an unborn baby, women who are pregnant or who may become||
9167|032|H|pregnant should not handle this medication or breathe the dust||
9167|033|H|from the tablets. It may cause abnormal sex organ development in||
9167|034|H|an unborn male infant.||
9167|035|H|   Use this medication regularly to get the most benefit from it.||
9167|036|H|Remember to use it at the same time each day. It may take up to 3||
9167|037|H|months to notice a benefit.||
9167|038|H|   You must continue to take this medication to maintain your||
9167|039|H|hair growth. When you stop taking finasteride, any gain in hair||
9167|040|H|quantity is generally lost within 12 months.||
9167|041|H|   Tell your doctor if your condition does not get better or if||
9167|042|H|it gets worse.||
9167|043|B|||
9167|044|S|SIDE EFFECTS:  Decreased sexual ability/desire may occur. In some||
9167|045|S|men, this medication can decrease the amount of semen released||
9167|046|S|during sex. This is harmless, but has continued in some men even||
9167|047|S|after stopping treatment. If any of these effects last or get||
9167|048|S|worse, tell your doctor or pharmacist promptly.||
9167|049|S|   Remember that this medication has been prescribed because your||
9167|050|S|doctor has judged that the benefit to you is greater than the||
9167|051|S|risk of side effects. Many people using this medication do not||
9167|052|S|have serious side effects.||
9167|053|S|   Tell your doctor right away if you have any serious side||
9167|054|S|effects, including: lump in the breast, nipple discharge, breast||
9167|055|S|enlargement/tenderness/pain, pain in the testicles, inability to||
9167|056|S|urinate.||
9167|057|S|   A very serious allergic reaction to this drug is rare.||
9167|058|S|However, get medical help right away if you notice any symptoms||
9167|059|S|of a serious allergic reaction, including: rash, itching/swelling||
9167|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9167|061|S|breathing.||
9167|062|S|   This is not a complete list of possible side effects. If you||
9167|063|S|notice other effects not listed above, contact your doctor or||
9167|064|S|pharmacist.||
9167|065|S|   In the US -||
9167|066|S|   Call your doctor for medical advice about side effects. You||
9167|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9167|068|S|www.fda.gov/medwatch.||
9167|069|S|   In Canada - Call your doctor for medical advice about side||
9167|070|S|effects. You may report side effects to Health Canada at||
9167|071|S|1-866-234-2345.||
9167|072|B|||
9167|073|P|PRECAUTIONS:  Before taking finasteride, tell your doctor or||
9167|074|P|pharmacist if you are allergic to it; or if you have any other||
9167|075|P|allergies. This product may contain inactive ingredients, which||
9167|076|P|can cause allergic reactions or other problems. Talk to your||
9167|077|P|pharmacist for more details.||
9167|078|P|   Before using this medication, tell your doctor or pharmacist||
9167|079|P|your medical history, especially of: liver disease, prostate||
9167|080|P|cancer, infections, urinary problems.||
9167|081|P|   Before having surgery, tell your doctor or dentist about all||
9167|082|P|the products you use (including prescription drugs,||
9167|083|P|nonprescription drugs, and herbal products).||
9167|084|P|   This medication should not be used in women, especially during||
9167|085|P|pregnancy or breastfeeding. It may harm an unborn or||
9167|086|P|breastfeeding baby. Consult your doctor if you have any questions||
9167|087|P|about this medication.||
9167|088|B|||
9167|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9167|090|I|medications work or increase your risk for serious side effects.||
9167|091|I|This document does not contain all possible drug interactions.||
9167|092|I|Keep a list of all the products you use (including||
9167|093|I|prescription/nonprescription drugs and herbal products) and share||
9167|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
9167|095|I|the dosage of any medicines without your doctor's approval.||
9167|096|I|   This medication may interfere with certain lab tests (such as||
9167|097|I|PSA levels), possibly causing false test results. Make sure lab||
9167|098|I|personnel and all your doctors know you use this drug.||
9167|099|B|||
9167|100|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9167|101|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9167|102|O|poison control center right away. US residents can call||
9167|103|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9167|104|B|||
9167|105|N|NOTES:  Do not share this drug with others.||
9167|106|N|   Follow your doctor's instructions for examining your breasts||
9167|107|N|and testicles, and report any lumps right away.||
9167|108|B|||
9167|109|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9167|110|D|remember. If it is near the time of the next dose, skip the||
9167|111|D|missed dose. Take your next dose at the regular time. Do not||
9167|112|D|double the dose to catch up.||
9167|113|B|||
9167|114|R|STORAGE:  Store at room temperature away from light and moisture.||
9167|115|R|Do not store in the bathroom. Keep all medications away from||
9167|116|R|children and pets.||
9167|117|R|   Do not flush medications down the toilet or pour them into a||
9167|118|R|drain unless instructed to do so. Properly discard this product||
9167|119|R|when it is expired or no longer needed. Consult your pharmacist||
9167|120|R|or local waste disposal company.||
9167|121|B|||
9167|122|A|Information last revised August 2025.||
9167|123|A|Copyright(c) 2025 First Databank, Inc.||
9167|124|B|||
9168|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9168|002|Z|does NOT have all possible information about this product. This||
9168|003|Z|information does not assure that this product is safe, effective,||
9168|004|Z|or appropriate for you. This information is not individual||
9168|005|Z|medical advice and does not substitute for the advice of your||
9168|006|Z|health care professional. Always ask your health care||
9168|007|Z|professional for complete information about this product and your||
9168|008|Z|specific health needs.||
9168|009|B|||
9168|010|T|PROPRANOLOL - ORAL||
9168|011|F|(pro-PRAN-oh-lol)||
9168|012|B|||
9168|013|C|COMMON BRAND NAME(S): Inderal||
9168|014|B|||
9168|015|W|WARNING:  Do not stop using this drug without first consulting||
9168|016|W|your doctor. Your condition may become worse when the drug is||
9168|017|W|suddenly stopped, especially if you have chest pain (angina) or||
9168|018|W|heart disease (such as coronary artery disease, ischemic heart||
9168|019|W|disease, high blood pressure). If your doctor decides you should||
9168|020|W|no longer use this drug, you must gradually decrease your dose||
9168|021|W|according to your doctor's instructions.||
9168|022|W|   When gradually stopping this medication, it is recommended||
9168|023|W|that you temporarily limit physical activity to decrease strain||
9168|024|W|on the heart. Get medical help right away if you develop:||
9168|025|W|worsening chest pain, tightness/pressure in the chest, chest pain||
9168|026|W|spreading to the jaw/neck/arm, unusual sweating, trouble||
9168|027|W|breathing, or fast/irregular heartbeat.||
9168|028|B|||
9168|029|U|USES:  This medication is a beta blocker used to treat high blood||
9168|030|U|pressure, irregular heartbeats, shaking (tremors), and other||
9168|031|U|conditions. It is used after a heart attack to improve the chance||
9168|032|U|of survival. It is also used to prevent migraine headaches and||
9168|033|U|chest pain (angina). Lowering high blood pressure helps prevent||
9168|034|U|strokes, heart attacks, and kidney problems. Preventing chest||
9168|035|U|pain can help improve your ability to exercise.||
9168|036|U|   This drug works by blocking the action of certain natural||
9168|037|U|chemicals in your body (such as epinephrine) that affect the||
9168|038|U|heart and blood vessels. This effect reduces heart rate, blood||
9168|039|U|pressure, and strain on the heart.||
9168|040|B|||
9168|041|V|OTHER USES:  This section contains uses of this drug that are not||
9168|042|V|listed in the approved professional labeling for the drug but||
9168|043|V|that may be prescribed by your health care professional. Use this||
9168|044|V|drug for a condition that is listed in this section only if it||
9168|045|V|has been so prescribed by your health care professional.||
9168|046|V|   This medication has also been used to control symptoms of||
9168|047|V|anxiety or overactive thyroid (hyperthyroidism).||
9168|048|B|||
9168|049|H|HOW TO USE:  See also Warning section.||
9168|050|H|   Take this medication by mouth as directed by your doctor,||
9168|051|H|usually 2 to 4 times daily. Take this medication before meals||
9168|052|H|(and at bedtime if taking 4 times daily). Measure the liquid||
9168|053|H|medication with a medication-measuring spoon or device. Do not||
9168|054|H|use a household spoon because you may not get the correct dose.||
9168|055|H|   The dosage is based on your medical condition and response to||
9168|056|H|treatment.||
9168|057|H|   Use this medication regularly to get the most benefit from it.||
9168|058|H|To help you remember, take it at the same times each day. Keep||
9168|059|H|taking this medication even if you feel well.||
9168|060|H|   This medication is used to help prevent chest pain or||
9168|061|H|migraines. It should not be used to treat chest pain or migraines||
9168|062|H|when they occur. Use other medications (such as nitroglycerin||
9168|063|H|tablets placed under the tongue for chest pain, sumatriptan for||
9168|064|H|migraines) to relieve sudden attacks as directed by your doctor.||
9168|065|H|Consult your doctor or pharmacist for details.||
9168|066|H|   If you also take certain drugs to lower your cholesterol (bile||
9168|067|H|acid-binding resins such as cholestyramine or colestipol), take||
9168|068|H|propranolol at least 1 hour before or at least 4 hours after||
9168|069|H|these medications.||
9168|070|H|   For the treatment of high blood pressure, it may take 1 to 2||
9168|071|H|weeks before you get the full benefit of this drug.||
9168|072|H|   Tell your doctor if your condition does not get better or if||
9168|073|H|it gets worse (for example, your blood pressure readings remain||
9168|074|H|high or increase, your chest pain or migraines occur more often).||
9168|075|B|||
9168|076|S|SIDE EFFECTS:  See also Warning and Precautions sections.||
9168|077|S|   Dizziness, lightheadedness, or tiredness may occur as your||
9168|078|S|body adjusts to the medication. Nausea/vomiting, stomach pain,||
9168|079|S|vision changes, trouble sleeping, and unusual dreams may also||
9168|080|S|occur. If any of these effects last or get worse, tell your||
9168|081|S|doctor or pharmacist promptly.||
9168|082|S|   To reduce the risk of dizziness and lightheadedness, get up||
9168|083|S|slowly when rising from a sitting or lying position.||
9168|084|S|   This drug may reduce blood flow to your hands and feet,||
9168|085|S|causing them to feel cold. Smoking may worsen this effect. Dress||
9168|086|S|warmly and avoid tobacco use.||
9168|087|S|   Remember that this medication has been prescribed because your||
9168|088|S|doctor has judged that the benefit to you is greater than the||
9168|089|S|risk of side effects. Many people using this medication do not||
9168|090|S|have serious side effects.||
9168|091|S|   Tell your doctor right away if you have any serious side||
9168|092|S|effects, including: blue fingers/toes, mental/mood changes (such||
9168|093|S|as depression), numbness/tingling of arms/legs, new or worsening||
9168|094|S|symptoms of heart failure (such as shortness of breath, swelling||
9168|095|S|ankles/feet, unusual tiredness, unusual/sudden weight gain), very||
9168|096|S|slow heartbeat, fainting, decreased sexual ability, increased||
9168|097|S|thirst/urination, easy bruising/bleeding, signs of infection||
9168|098|S|(such as sore throat that doesn't go away, fever, chills),||
9168|099|S|aching/swollen joints.||
9168|100|S|   A very serious allergic reaction to this drug is rare.||
9168|101|S|However, get medical help right away if you notice any symptoms||
9168|102|S|of a serious allergic reaction, including: rash, itching/swelling||
9168|103|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9168|104|S|breathing.||
9168|105|S|   This is not a complete list of possible side effects. If you||
9168|106|S|notice other effects not listed above, contact your doctor or||
9168|107|S|pharmacist.||
9168|108|S|   In the US -||
9168|109|S|   Call your doctor for medical advice about side effects. You||
9168|110|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9168|111|S|www.fda.gov/medwatch.||
9168|112|S|   In Canada - Call your doctor for medical advice about side||
9168|113|S|effects. You may report side effects to Health Canada at||
9168|114|S|1-866-234-2345.||
9168|115|B|||
9168|116|P|PRECAUTIONS:  Before taking propranolol, tell your doctor or||
9168|117|P|pharmacist if you are allergic to it; or if you have had a||
9168|118|P|serious reaction to other beta blockers (such as metoprolol); or||
9168|119|P|if you have any other allergies. This product may contain||
9168|120|P|inactive ingredients, which can cause allergic reactions or other||
9168|121|P|problems. Talk to your pharmacist for more details.||
9168|122|P|   Before using this medication, tell your doctor or pharmacist||
9168|123|P|your medical history, especially of: breathing problems (such as||
9168|124|P|asthma, bronchitis, emphysema), heart failure, certain types of||
9168|125|P|heart rhythm problems (sinus bradycardia, Wolff-Parkinson-White||
9168|126|P|syndrome, second- or third-degree atrioventricular block),||
9168|127|P|overactive thyroid (hyperthyroidism), kidney disease, liver||
9168|128|P|disease, blood circulation problems (such as Raynaud's disease),||
9168|129|P|a certain adrenal gland tumor (pheochromocytoma), mental/mood||
9168|130|P|disorders (such as depression), certain muscle/nerve disease||
9168|131|P|(myasthenia gravis), severe allergic reactions.||
9168|132|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9168|133|P|can make you more dizzy. Do not drive, use machinery, or do||
9168|134|P|anything that needs alertness until you can do it safely. Limit||
9168|135|P|alcoholic beverages. Talk to your doctor if you are using||
9168|136|P|marijuana (cannabis).||
9168|137|P|   Liquid forms of this medication may contain alcohol. Caution||
9168|138|P|is advised if you have alcohol dependence or liver disease. Ask||
9168|139|P|your doctor or pharmacist about using this product safely.||
9168|140|P|   Before having surgery, tell your doctor or dentist about all||
9168|141|P|the products you use (including prescription drugs,||
9168|142|P|nonprescription drugs, and herbal products).||
9168|143|P|   This product may prevent the fast/pounding heartbeat you would||
9168|144|P|usually feel when your blood sugar level falls too low||
9168|145|P|(hypoglycemia). The risk is higher if you have diabetes, or are||
9168|146|P|vomiting, fasting, or not eating regularly. Other symptoms of low||
9168|147|P|blood sugar level, such as dizziness and sweating, are not||
9168|148|P|affected by this drug.||
9168|149|P|   If you have diabetes, this product may make it harder to||
9168|150|P|control your blood sugar levels. Check your blood sugar levels||
9168|151|P|regularly as directed by your doctor. Tell your doctor right away||
9168|152|P|if you have symptoms of high blood sugar such as increased||
9168|153|P|thirst/urination. Your doctor may need to adjust your diabetes||
9168|154|P|medication, exercise program, or diet.||
9168|155|P|   Children may be at greater risk for low blood sugar||
9168|156|P|(hypoglycemia) while using this drug, especially if they are||
9168|157|P|vomiting or not eating regularly. To help prevent low blood||
9168|158|P|sugar, make sure children eat regularly. If your child cannot eat||
9168|159|P|regularly, is vomiting, or has symptoms of low blood sugar (such||
9168|160|P|as sweating, shaking), tell the doctor right away.||
9168|161|P|   During pregnancy, this medication should be used only when||
9168|162|P|clearly needed. Infants exposed to this medication during||
9168|163|P|pregnancy may have low birth weight, low blood sugar, or slow||
9168|164|P|breathing/heartbeat. Discuss the risks and benefits with your||
9168|165|P|doctor.||
9168|166|P|   This drug passes into breast milk. Consult your doctor before||
9168|167|P|breastfeeding.||
9168|168|B|||
9168|169|I|DRUG INTERACTIONS:  See also How to Use section.||
9168|170|I|   Drug interactions may change how your medications work or||
9168|171|I|increase your risk for serious side effects. This document does||
9168|172|I|not contain all possible drug interactions. Keep a list of all||
9168|173|I|the products you use (including prescription/nonprescription||
9168|174|I|drugs and herbal products) and share it with your doctor and||
9168|175|I|pharmacist. Do not start, stop, or change the dosage of any||
9168|176|I|medicines without your doctor's approval.||
9168|177|I|   Some products that may interact with this drug are:||
9168|178|I|epinephrine, fingolimod.||
9168|179|I|   Other medications can affect the removal of propranolol from||
9168|180|I|your body, which may affect how propranolol works. Examples||
9168|181|I|include quinidine, rifamycins (such as rifabutin), among others.||
9168|182|I|   This medication can slow down the removal of other medications||
9168|183|I|from your body, which may affect how they work. Examples of||
9168|184|I|affected drugs include fezolinetant, propafenone, thioridazine,||
9168|185|I|among others.||
9168|186|I|   Some products have ingredients that could raise your heart||
9168|187|I|rate or blood pressure. Tell your pharmacist what products you||
9168|188|I|are using, and ask how to use them safely (especially||
9168|189|I|cough-and-cold products, diet aids, or NSAIDs such as||
9168|190|I|ibuprofen/naproxen).||
9168|191|I|   This medication may interfere with certain lab tests (such as||
9168|192|I|glaucoma screening test), possibly causing false test results.||
9168|193|I|Make sure lab personnel and all your doctors know you use this||
9168|194|I|drug.||
9168|195|B|||
9168|196|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9168|197|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9168|198|O|poison control center right away. US residents can call||
9168|199|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9168|200|O|Symptoms of overdose may include: very slow heartbeat, severe||
9168|201|O|dizziness, fainting.||
9168|202|B|||
9168|203|N|NOTES:  Do not share this medication with others.||
9168|204|N|   Lifestyle changes such as stress reduction programs, exercise,||
9168|205|N|and dietary changes may increase the effectiveness of this||
9168|206|N|medicine. Talk to your doctor or pharmacist about lifestyle||
9168|207|N|changes that might benefit you.||
9168|208|N|   Have your blood pressure and pulse (heart rate) checked||
9168|209|N|regularly while taking this medication. Learn how to monitor your||
9168|210|N|own blood pressure and pulse at home, and share the results with||
9168|211|N|your doctor.||
9168|212|B|||
9168|213|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9168|214|D|remember. If it is near the time of the next dose, skip the||
9168|215|D|missed dose. Take your next dose at the regular time. Do not||
9168|216|D|double the dose to catch up.||
9168|217|B|||
9168|218|R|STORAGE:  Store at room temperature away from light and moisture.||
9168|219|R|Do not store in the bathroom. Keep all medications away from||
9168|220|R|children and pets.||
9168|221|R|   Do not flush medications down the toilet or pour them into a||
9168|222|R|drain unless instructed to do so. Properly discard this product||
9168|223|R|when it is expired or no longer needed. Consult your pharmacist||
9168|224|R|or local waste disposal company.||
9168|225|B|||
9168|226|M|MEDICAL ALERT:  Your condition can cause complications in a||
9168|227|M|medical emergency. For information about enrolling in MedicAlert,||
9168|228|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9168|229|B|||
9168|230|A|Information last revised May 2025.||
9168|231|A|Copyright(c) 2025 First Databank, Inc.||
9168|232|B|||
9170|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9170|002|Z|does NOT have all possible information about this product. This||
9170|003|Z|information does not assure that this product is safe, effective,||
9170|004|Z|or appropriate for you. This information is not individual||
9170|005|Z|medical advice and does not substitute for the advice of your||
9170|006|Z|health care professional. Always ask your health care||
9170|007|Z|professional for complete information about this product and your||
9170|008|Z|specific health needs.||
9170|009|B|||
9170|010|T|LIDOCAINE - TOPICAL||
9170|011|F|(LYE-doe-kane)||
9170|012|B|||
9170|013|C|COMMON BRAND NAME(S): Lidamantle, Xylocaine||
9170|014|B|||
9170|015|U|USES:  This medication is used on the skin to stop itching and||
9170|016|U|pain from certain skin conditions (such as scrapes, minor burns,||
9170|017|U|eczema, insect bites) and to treat minor discomfort and itching||
9170|018|U|caused by hemorrhoids and certain other problems of the||
9170|019|U|genital/anal area (such as anal fissures, itching around the||
9170|020|U|vagina/rectum). Some forms of this medication are also used to||
9170|021|U|decrease discomfort or pain during certain medical||
9170|022|U|procedures/exams (such as sigmoidoscopy, cystoscopy). Lidocaine||
9170|023|U|is a local anesthetic that works by causing temporary||
9170|024|U|numbness/loss of feeling in the skin and mucous membranes.||
9170|025|B|||
9170|026|H|HOW TO USE:  If you are using the over-the-counter product to||
9170|027|H|self-treat, read and follow all directions on the product package||
9170|028|H|before using this medication. If you have any questions, consult||
9170|029|H|your pharmacist. If your doctor has prescribed this medication,||
9170|030|H|use it as directed.||
9170|031|H|   Before use on the skin, clean and dry the affected area as||
9170|032|H|directed. Apply a thin layer of medication to the affected area||
9170|033|H|of skin, usually 2 to 3 times a day or as directed.||
9170|034|H|   If you are using the spray, shake the canister well before||
9170|035|H|using. While holding the canister 3-5 inches (8-13 centimeters)||
9170|036|H|from the affected area, spray until wet. If the affected area is||
9170|037|H|on the face, spray the medication onto your hand and apply to the||
9170|038|H|face. Do not spray near your eyes, nose, or mouth.||
9170|039|H|   If you are using the foam, shake the canister well before||
9170|040|H|using. Spray the foam onto your hand and apply to the affected||
9170|041|H|area.||
9170|042|H|   Do not use on large areas of the body, cover the area with||
9170|043|H|waterproof bandages or plastic, or apply heat unless directed to||
9170|044|H|do so by your doctor. These may increase the risk of serious side||
9170|045|H|effects.||
9170|046|H|   Wash hands immediately after use unless you are treating an||
9170|047|H|area on the hands. Avoid getting the product in eyes, nose, or||
9170|048|H|ears. If the medication gets in these areas, rinse the area||
9170|049|H|immediately with clean water.||
9170|050|H|   The dosage is based on your medical condition and response to||
9170|051|H|treatment. Do not use more of this product, use it more often, or||
9170|052|H|keep using it longer than directed. If there is an infection or||
9170|053|H|sore in the area to be treated, do not use this medication||
9170|054|H|without consulting your doctor first.||
9170|055|H|   If your condition lasts or gets worse, or if you think you may||
9170|056|H|have a serious medical problem, get medical help right away.||
9170|057|B|||
9170|058|S|SIDE EFFECTS:  Temporary redness, stinging, and a little bit of||
9170|059|S|swelling may occur at the application site. If these effects last||
9170|060|S|or get worse, tell your doctor right away.||
9170|061|S|   If your doctor has directed you to use this medication,||
9170|062|S|remember that your doctor has judged that the benefit to you is||
9170|063|S|greater than the risk of side effects. Many people using this||
9170|064|S|medication do not have serious side effects.||
9170|065|S|   Get medical help right away if you have any very serious side||
9170|066|S|effects, including: slow/shallow breathing, seizures,||
9170|067|S|pale/bluish/gray skin, unusual tiredness, shortness of breath,||
9170|068|S|fast/slow/irregular heartbeat.||
9170|069|S|   A very serious allergic reaction to this drug is rare.||
9170|070|S|However, get medical help right away if you notice any symptoms||
9170|071|S|of a serious allergic reaction, including: new/worsening rash,||
9170|072|S|new or worsening itching/swelling (especially of the||
9170|073|S|face/tongue/throat), severe dizziness, trouble breathing.||
9170|074|S|   This is not a complete list of possible side effects. If you||
9170|075|S|notice any other effects not listed above, contact your doctor or||
9170|076|S|pharmacist.||
9170|077|S|   In the US -||
9170|078|S|   Call your doctor for medical advice about side effects. You||
9170|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9170|080|S|www.fda.gov/medwatch.||
9170|081|S|   In Canada - Call your doctor for medical advice about side||
9170|082|S|effects. You may report side effects to Health Canada at||
9170|083|S|1-866-234-2345.||
9170|084|B|||
9170|085|P|PRECAUTIONS:  Before using lidocaine, tell your doctor or||
9170|086|P|pharmacist if you are allergic to it; or to other amide type||
9170|087|P|anesthetics (such as bupivacaine, prilocaine); or if you have any||
9170|088|P|other allergies. This product may contain inactive ingredients,||
9170|089|P|which can cause allergic reactions or other problems. Talk to||
9170|090|P|your pharmacist for more details.||
9170|091|P|   Before using this medication, tell your doctor or pharmacist||
9170|092|P|your medical history, especially of: broken skin/infection in the||
9170|093|P|area where lidocaine is to be used, heart disease, liver disease,||
9170|094|P|a certain blood disorder (methemoglobinemia).||
9170|095|P|   If you are going to have an MRI test, tell testing personnel||
9170|096|P|that you are using this product. Some brands of this medication||
9170|097|P|may contain metals that can cause serious burns during an MRI and||
9170|098|P|should not be used before MRI imaging. Ask your doctor or||
9170|099|P|pharmacist for questions about your particular brand.||
9170|100|P|   Before having surgery, tell your doctor or dentist about all||
9170|101|P|the products you use (including prescription drugs,||
9170|102|P|nonprescription drugs, and herbal products).||
9170|103|P|   Children may be more sensitive to the side effects of this||
9170|104|P|drug.||
9170|105|P|   During pregnancy, this medication should be used only when||
9170|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
9170|107|P|   This medication passes into breast milk, but is unlikely to||
9170|108|P|harm a nursing infant. Consult your doctor before breastfeeding.||
9170|109|B|||
9170|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9170|111|I|medications work or increase your risk for serious side effects.||
9170|112|I|This document does not contain all possible drug interactions.||
9170|113|I|Keep a list of all the products you use (including||
9170|114|I|prescription/nonprescription drugs and herbal products) and share||
9170|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
9170|116|I|the dosage of any medicines without your doctor's approval.||
9170|117|B|||
9170|118|O|OVERDOSE:  This medicine may be harmful if inhaled or swallowed.||
9170|119|O|If someone has overdosed and has serious symptoms such as passing||
9170|120|O|out or trouble breathing, call 911. Otherwise, call a poison||
9170|121|O|control center right away. US residents can call 1-800-222-1222.||
9170|122|O|Canada residents can call 1-844-764-7669. Symptoms of overdose||
9170|123|O|may include: drowsiness, irregular heartbeat, seizures.||
9170|124|B|||
9170|125|N|NOTES:  Keep all medical and lab appointments.||
9170|126|B|||
9170|127|D|MISSED DOSE:  If you are using this product on a regular schedule||
9170|128|D|and miss a dose, use it as soon as you remember. If it is near||
9170|129|D|the time of the next dose, skip the missed dose. Use your next||
9170|130|D|dose at the regular time. Do not double the dose to catch up.||
9170|131|B|||
9170|132|R|STORAGE:  Store at room temperature. Do not freeze. Do not store||
9170|133|R|the gel or the foam or spray canisters near high heat, and do not||
9170|134|R|store or use it near open flame. Because the foam or spray||
9170|135|R|canisters are under pressure, do not puncture or burn the||
9170|136|R|container. Keep all medications away from children and pets.||
9170|137|R|   Do not flush medications down the toilet or pour them into a||
9170|138|R|drain unless instructed to do so. Properly discard this product||
9170|139|R|when it is expired or no longer needed. Consult your pharmacist||
9170|140|R|or local waste disposal company.||
9170|141|B|||
9170|142|A|Information last revised February 2025.||
9170|143|A|Copyright(c) 2025 First Databank, Inc.||
9170|144|B|||
9172|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9172|002|Z|does NOT have all possible information about this product. This||
9172|003|Z|information does not assure that this product is safe, effective,||
9172|004|Z|or appropriate for you. This information is not individual||
9172|005|Z|medical advice and does not substitute for the advice of your||
9172|006|Z|health care professional. Always ask your health care||
9172|007|Z|professional for complete information about this product and your||
9172|008|Z|specific health needs.||
9172|009|B|||
9172|010|T|PROMETHAZINE/PHENYLEPHRINE - ORAL||
9172|011|F|(pro-METH-uh-zeen/fen-ill-EFF-rin)||
9172|012|B|||
9172|013|C|COMMON BRAND NAME(S): Phenergan VC||
9172|014|B|||
9172|015|W|WARNING:  Cough-and-cold products have not been shown to be safe||
9172|016|W|or effective in children younger than 6 years. Do not use this||
9172|017|W|product to treat cold symptoms in children younger than 6 years||
9172|018|W|unless specifically directed by the doctor. Some products||
9172|019|W|(including some long-acting tablets/capsules) are not recommended||
9172|020|W|for use in children younger than 12 years. Do not use this||
9172|021|W|product to make a child sleepy.||
9172|022|W|   This product is not recommended for use in children younger||
9172|023|W|than 2 years since it might cause serious (possibly fatal)||
9172|024|W|slow/shallow breathing. In children 2 years and older, carefully||
9172|025|W|follow the doctor's directions to use the lowest effective dose.||
9172|026|W|Do not give more often than prescribed. Talk to the doctor or||
9172|027|W|pharmacist before giving other cough-and-cold medication that||
9172|028|W|might contain the same or similar ingredients that might also||
9172|029|W|affect breathing. Get immediate medical help if you notice||
9172|030|W|unusual slow/shallow breathing.||
9172|031|B|||
9172|032|U|USES:  See also Warning section.||
9172|033|U|   This combination medication is used to temporarily relieve||
9172|034|U|symptoms caused by the common cold or allergies. Promethazine is||
9172|035|U|an antihistamine that relieves watery eyes, itchy||
9172|036|U|eyes/nose/throat, runny nose, and sneezing. Phenylephrine is a||
9172|037|U|decongestant that helps relieve stuffy nose and ear congestion||
9172|038|U|symptoms.||
9172|039|U|   Cough-and-cold products do not cure or shorten the length of||
9172|040|U|the common cold and may cause serious side effects if not used||
9172|041|U|properly. Ask your doctor or pharmacist about other ways to||
9172|042|U|relieve cough and cold symptoms (such as drinking enough fluids,||
9172|043|U|using a humidifier or saline nose drops/spray).||
9172|044|B|||
9172|045|H|HOW TO USE:  Take this medication by mouth with or without food||
9172|046|H|as directed by your doctor, usually every 4 to 6 hours as needed.||
9172|047|H|This medication may be taken with food if stomach upset occurs.||
9172|048|H|Drink plenty of fluids when you use this medication unless||
9172|049|H|otherwise directed by your doctor.||
9172|050|H|   Carefully measure the dose using a special measuring||
9172|051|H|device/spoon. Do not use a household spoon because you may not||
9172|052|H|get the correct dose.||
9172|053|H|   Tell your doctor if your condition lasts for more than 1 week,||
9172|054|H|if it gets worse, or if it occurs with a headache that doesn't go||
9172|055|H|away, fever, or rash. These may be symptoms of a serious medical||
9172|056|H|problem and should be checked by a doctor.||
9172|057|B|||
9172|058|S|SIDE EFFECTS:  Drowsiness, dizziness, headache, upset stomach,||
9172|059|S|nausea, constipation, or dry mouth may occur. If any of these||
9172|060|S|effects last or get worse, tell your doctor or pharmacist||
9172|061|S|promptly.||
9172|062|S|   Remember that this medication has been prescribed because your||
9172|063|S|doctor has judged that the benefit to you is greater than the||
9172|064|S|risk of side effects. Many people using this medication do not||
9172|065|S|have serious side effects.||
9172|066|S|   This medication may raise your blood pressure. Check your||
9172|067|S|blood pressure regularly and tell your doctor if the results are||
9172|068|S|high.||
9172|069|S|   Tell your doctor right away if you have any serious side||
9172|070|S|effects, including: mental/mood changes (such as confusion,||
9172|071|S|hallucinations), ringing in the ears, shaking (tremors),||
9172|072|S|difficulty urinating, vision changes (such as blurred/double||
9172|073|S|vision), easy bruising/bleeding, uncontrolled behaviors/movements||
9172|074|S|(such as fixed upward stare, neck twisting, tongue movements).||
9172|075|S|   Get medical help right away if you have any very serious side||
9172|076|S|effects, including: slow/shallow breathing, seizure.||
9172|077|S|   This medication may rarely cause a very serious condition||
9172|078|S|called neuroleptic malignant syndrome (NMS). Get medical help||
9172|079|S|right away if you have any of the following symptoms: fever,||
9172|080|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
9172|081|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
9172|082|S|signs of kidney problems (such as change in the amount of urine).||
9172|083|S|   A very serious allergic reaction to this drug is rare.||
9172|084|S|However, get medical help right away if you notice any symptoms||
9172|085|S|of a serious allergic reaction, including: rash, itching/swelling||
9172|086|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9172|087|S|breathing.||
9172|088|S|   This is not a complete list of possible side effects. If you||
9172|089|S|notice other effects not listed above, contact your doctor or||
9172|090|S|pharmacist.||
9172|091|S|   In the US -||
9172|092|S|   Call your doctor for medical advice about side effects. You||
9172|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9172|094|S|www.fda.gov/medwatch.||
9172|095|S|   In Canada - Call your doctor for medical advice about side||
9172|096|S|effects. You may report side effects to Health Canada at||
9172|097|S|1-866-234-2345.||
9172|098|B|||
9172|099|P|PRECAUTIONS:  See also Warning section.||
9172|100|P|   Before taking this medication, tell your doctor or pharmacist||
9172|101|P|if you are allergic to promethazine or phenylephrine; or if you||
9172|102|P|have any other allergies. This product may contain inactive||
9172|103|P|ingredients, which can cause allergic reactions or other||
9172|104|P|problems. Talk to your pharmacist for more details.||
9172|105|P|   Before using this medication, tell your doctor or pharmacist||
9172|106|P|your medical history, especially of: blood/immune system problems||
9172|107|P|(such as bone marrow depression), breathing problems (such as||
9172|108|P|asthma, emphysema, sleep apnea), diabetes, glaucoma, heart||
9172|109|P|problems (such as angina, irregular heartbeat), high blood||
9172|110|P|pressure, liver problems, seizure, stomach/bowel problems (such||
9172|111|P|as ulcer, blockage), overactive thyroid (hyperthyroidism),||
9172|112|P|difficulty urinating (such as due to enlarged prostate).||
9172|113|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9172|114|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9172|115|P|machinery, or do anything that needs alertness until you can do||
9172|116|P|it safely. Children should be supervised to avoid injury during||
9172|117|P|bicycle riding or other possibly hazardous activities. Limit||
9172|118|P|alcoholic beverages. Talk to your doctor if you are using||
9172|119|P|marijuana (cannabis).||
9172|120|P|   This medication may make you more sensitive to the sun. Limit||
9172|121|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9172|122|P|sunscreen and wear protective clothing when outdoors. Tell your||
9172|123|P|doctor right away if you get sunburned or have skin||
9172|124|P|blisters/redness.||
9172|125|P|   Liquid forms of this medication may contain sugar, alcohol, or||
9172|126|P|aspartame. Caution is advised if you have diabetes, alcohol||
9172|127|P|dependence, liver disease, phenylketonuria (PKU), or any other||
9172|128|P|condition that requires you to limit/avoid these substances in||
9172|129|P|your diet. Ask your doctor or pharmacist about using this product||
9172|130|P|safely.||
9172|131|P|   Before having surgery, tell your doctor or dentist about all||
9172|132|P|the products you use (including prescription drugs,||
9172|133|P|nonprescription drugs, and herbal products).||
9172|134|P|   Children may be more sensitive to the side effects of this||
9172|135|P|drug, especially slowed breathing and uncontrolled movements (See||
9172|136|P|also Warning section). Young children may become excited/agitated||
9172|137|P|instead of drowsy.||
9172|138|P|   Older adults may be more sensitive to the effects of the drug,||
9172|139|P|especially dizziness, drowsiness, confusion, constipation,||
9172|140|P|trouble urinating, trouble sleeping, or fast/irregular heartbeat.||
9172|141|P|Dizziness, drowsiness, and confusion can increase the risk of||
9172|142|P|falling.||
9172|143|P|   During pregnancy, this medication should be used only if||
9172|144|P|clearly needed. Discuss the risks and benefits with your doctor.||
9172|145|P|   It is unknown if promethazine passes into breast milk.||
9172|146|P|Phenylephrine passes into breast milk. Consult your doctor before||
9172|147|P|breastfeeding.||
9172|148|B|||
9172|149|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9172|150|I|medications work or increase your risk for serious side effects.||
9172|151|I|This document does not contain all possible drug interactions.||
9172|152|I|Keep a list of all the products you use (including||
9172|153|I|prescription/nonprescription drugs and herbal products) and share||
9172|154|I|it with your doctor and pharmacist. Do not start, stop, or change||
9172|155|I|the dosage of any medicines without your doctor's approval.||
9172|156|I|   Some products that may interact with this drug include:||
9172|157|I|antihistamines applied to the skin (such as diphenhydramine||
9172|158|I|cream, ointment, spray), cabergoline, metoclopramide, pergolide.||
9172|159|I|   Taking MAO inhibitors with this medication may cause a serious||
9172|160|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9172|161|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9172|162|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9172|163|I|selegiline, tranylcypromine) during treatment with this||
9172|164|I|medication. Most MAO inhibitors should also not be taken for two||
9172|165|I|weeks before treatment with this medication. Ask your doctor when||
9172|166|I|to start or stop taking this medication.||
9172|167|I|   The risk of serious side effects (such as slow/shallow||
9172|168|I|breathing, severe drowsiness/dizziness) may be increased if this||
9172|169|I|medication is taken with other products that may also cause||
9172|170|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
9172|171|I|if you are taking other products such as opioid pain or cough||
9172|172|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9172|173|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9172|174|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9172|175|I|cyclobenzaprine), or other antihistamines (such as cetirizine,||
9172|176|I|diphenhydramine).||
9172|177|I|   Check the labels on all your medicines (such as allergy or||
9172|178|I|cough-and-cold products) because they may contain ingredients||
9172|179|I|that cause drowsiness. Ask your pharmacist about using those||
9172|180|I|products safely.||
9172|181|I|   This medication may interfere with certain lab tests (such as||
9172|182|I|some pregnancy tests, blood sugar tests, allergy skin test),||
9172|183|I|possibly causing false test results. Make sure lab personnel and||
9172|184|I|all your doctors know you use this drug.||
9172|185|B|||
9172|186|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9172|187|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9172|188|O|poison control center right away. US residents can call||
9172|189|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9172|190|O|Symptoms of overdose may include: confusion, slowed breathing,||
9172|191|O|seizure.||
9172|192|B|||
9172|193|N|NOTES:  Do not share this medication with others.||
9172|194|B|||
9172|195|D|MISSED DOSE:  If you are taking this medication on a regular||
9172|196|D|schedule and miss a dose, take it as soon as you remember. If it||
9172|197|D|is near the time of the next dose, skip the missed dose. Take||
9172|198|D|your next dose at the regular time. Do not double the dose to||
9172|199|D|catch up.||
9172|200|B|||
9172|201|R|STORAGE:  Store at room temperature away from light and moisture.||
9172|202|R|Do not store in the bathroom. Keep all medications away from||
9172|203|R|children and pets.||
9172|204|R|   Do not flush medications down the toilet or pour them into a||
9172|205|R|drain unless instructed to do so. Properly discard this product||
9172|206|R|when it is expired or no longer needed. Consult your pharmacist||
9172|207|R|or local waste disposal company.||
9172|208|B|||
9172|209|A|Information last revised July 2025.||
9172|210|A|Copyright(c) 2025 First Databank, Inc.||
9172|211|B|||
9173|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9173|002|Z|does NOT have all possible information about this product. This||
9173|003|Z|information does not assure that this product is safe, effective,||
9173|004|Z|or appropriate for you. This information is not individual||
9173|005|Z|medical advice and does not substitute for the advice of your||
9173|006|Z|health care professional. Always ask your health care||
9173|007|Z|professional for complete information about this product and your||
9173|008|Z|specific health needs.||
9173|009|B|||
9173|010|T|NAPHAZOLINE - OPHTHALMIC||
9173|011|F|(nah-FAZZ-oh-leen)||
9173|012|B|||
9173|013|C|COMMON BRAND NAME(S): Albalon, Naphcon, Vasocon||
9173|014|B|||
9173|015|U|USES:  Naphazoline is a decongestant used to relieve redness,||
9173|016|U|puffiness, and itchy/watering eyes due to colds, allergies, or||
9173|017|U|eye irritations (smog, swimming, or wearing contact lenses). It||
9173|018|U|is known as a sympathomimetic (alpha receptor agonist) that works||
9173|019|U|in the eye to decrease congestion.||
9173|020|U|   Some brands of naphazoline eye drops also contain other||
9173|021|U|ingredients. Lubricants (such as glycerin, hypromellose, or||
9173|022|U|polyethylene glycol 300) help protect the eyes from more||
9173|023|U|irritation. Zinc sulfate, an astringent, helps reduce redness and||
9173|024|U|irritation.||
9173|025|B|||
9173|026|H|HOW TO USE:  Follow all directions on the product package. If||
9173|027|H|your doctor has prescribed this medication, use this medication||
9173|028|H|in the affected eye(s) as directed by your doctor. If you have||
9173|029|H|any questions, ask your doctor or pharmacist.||
9173|030|H|   To apply eye drops, wash your hands first. To avoid||
9173|031|H|contamination, do not touch the dropper tip or let it touch your||
9173|032|H|eye or any other surface.||
9173|033|H|   Remove contact lenses before applying the eye drops. Wait at||
9173|034|H|least 10 minutes after using this medication before inserting||
9173|035|H|contact lenses.||
9173|036|H|   Before using, check this product for cloudiness or||
9173|037|H|discoloration. If either is present, do not use the liquid.||
9173|038|H|   Tilt your head back, look upward, and pull down the lower||
9173|039|H|eyelid to make a pouch. Hold the dropper directly over the eye||
9173|040|H|and place 1 drop into the pouch. Look downward and gently close||
9173|041|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
9173|042|H|the eye near the nose and apply gentle pressure. This will||
9173|043|H|prevent the medication from draining away from the eye. Try not||
9173|044|H|to blink and do not rub the eye. Repeat these steps if your dose||
9173|045|H|is for more than 1 drop and for the other eye if so directed.||
9173|046|H|   Do not rinse the dropper. Replace the dropper cap tightly||
9173|047|H|after each use.||
9173|048|H|   If you are using another kind of eye medication (such as drops||
9173|049|H|or ointments), wait at least 5 minutes before applying other||
9173|050|H|medications. Use eye drops before eye ointments to allow the eye||
9173|051|H|drops to enter the eye.||
9173|052|H|   Wait several minutes for your vision to clear before driving||
9173|053|H|or operating machinery.||
9173|054|H|   Overuse of this type of medication may result in increased eye||
9173|055|H|redness (rebound hyperemia). Tell your doctor if this occurs or||
9173|056|H|if your condition lasts or gets worse after 48 hours. If you||
9173|057|H|develop eye pain/vision changes or think you may have a serious||
9173|058|H|medical problem, get medical help right away.||
9173|059|B|||
9173|060|S|SIDE EFFECTS:  Stinging, redness, widened pupils, or blurred||
9173|061|S|vision may occur. If any of these effects last or get worse, tell||
9173|062|S|your doctor or pharmacist promptly.||
9173|063|S|   If your doctor has directed you to use this medication,||
9173|064|S|remember that your doctor has judged that the benefit to you is||
9173|065|S|greater than the risk of side effects. Many people using this||
9173|066|S|medication do not have serious side effects.||
9173|067|S|   Tell your doctor right away if you have any serious side||
9173|068|S|effects, including: eye pain, other vision problems, worsening||
9173|069|S|redness/itching/swelling in or around the eyes, dizziness,||
9173|070|S|nausea, sweating, drowsiness, weakness, nervousness, headache,||
9173|071|S|decrease in body temperature, irregular heartbeat.||
9173|072|S|   A very serious allergic reaction to this drug is rare.||
9173|073|S|However, get medical help right away if you notice any symptoms||
9173|074|S|of a serious allergic reaction, including: rash, itching/swelling||
9173|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9173|076|S|breathing.||
9173|077|S|   This is not a complete list of possible side effects. If you||
9173|078|S|notice other effects not listed above, contact your doctor or||
9173|079|S|pharmacist.||
9173|080|S|   In the US -||
9173|081|S|   Call your doctor for medical advice about side effects. You||
9173|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9173|083|S|www.fda.gov/medwatch.||
9173|084|S|   In Canada - Call your doctor for medical advice about side||
9173|085|S|effects. You may report side effects to Health Canada at||
9173|086|S|1-866-234-2345.||
9173|087|B|||
9173|088|P|PRECAUTIONS:  Before using naphazoline, tell your doctor or||
9173|089|P|pharmacist if you are allergic to it; or if you have any other||
9173|090|P|allergies. This product may contain inactive ingredients (such as||
9173|091|P|preservatives like benzalkonium chloride), which can cause||
9173|092|P|allergic reactions or other problems. Talk to your pharmacist for||
9173|093|P|more details.||
9173|094|P|   Before using this medication, tell your doctor or pharmacist||
9173|095|P|your medical history, especially of: heart problems (such as high||
9173|096|P|blood pressure), glaucoma, diabetes, eye infection/injury,||
9173|097|P|overactive thyroid (hyperthyroidism).||
9173|098|P|   After you apply this drug, your vision may become temporarily||
9173|099|P|blurred. This drug may also rarely make you dizzy or drowsy.||
9173|100|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9173|101|P|drowsy. Do not drive, use machinery, or do anything that needs||
9173|102|P|alertness or clear vision until you can do it safely. Limit||
9173|103|P|alcoholic beverages. Talk to your doctor if you are using||
9173|104|P|marijuana (cannabis).||
9173|105|P|   During pregnancy, this medication should be used only when||
9173|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
9173|107|P|   It is unknown if this drug passes into breast milk. Consult||
9173|108|P|your doctor before breastfeeding.||
9173|109|B|||
9173|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9173|111|I|medications work or increase your risk for serious side effects.||
9173|112|I|This document does not contain all possible drug interactions.||
9173|113|I|Keep a list of all the products you use (including||
9173|114|I|prescription/nonprescription drugs and herbal products) and share||
9173|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
9173|116|I|the dosage of any medicines without your doctor's approval.||
9173|117|B|||
9173|118|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9173|119|O|has overdosed and has serious symptoms such as passing out or||
9173|120|O|trouble breathing, call 911. Otherwise, call a poison control||
9173|121|O|center right away. US residents can call 1-800-222-1222. Canada||
9173|122|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9173|123|O|include: drowsiness, decreased body temperature.||
9173|124|B|||
9173|125|N|NOTES:  If your symptoms are due to allergies, avoid allergens||
9173|126|N|that may be the cause of your symptoms. Some common causes of||
9173|127|N|allergies include pollen, grasses, weeds, dust mites, and pet||
9173|128|N|dander.||
9173|129|N|   Keep all medical and lab appointments.||
9173|130|N|   If this medication has been prescribed for you, use it for||
9173|131|N|your current condition only. Do not use it later for another||
9173|132|N|condition unless directed to do so by your doctor. A different||
9173|133|N|medication may be necessary in that case.||
9173|134|B|||
9173|135|D|MISSED DOSE:  If your doctor has directed you to use this||
9173|136|D|medication on a regular schedule and you miss a dose, use it as||
9173|137|D|soon as you remember. If it is near the time of the next dose,||
9173|138|D|skip the missed dose. Use your next dose at the regular time. Do||
9173|139|D|not double the dose to catch up.||
9173|140|B|||
9173|141|R|STORAGE:  Store at room temperature away from light. Discard if||
9173|142|R|drops become discolored or cloudy. Keep all medications away from||
9173|143|R|children and pets.||
9173|144|R|   Do not flush medications down the toilet or pour them into a||
9173|145|R|drain unless instructed to do so. Properly discard this product||
9173|146|R|when it is expired or no longer needed. Consult your pharmacist||
9173|147|R|or local waste disposal company.||
9173|148|B|||
9173|149|A|Information last revised November 2024.||
9173|150|A|Copyright(c) 2025 First Databank, Inc.||
9173|151|B|||
9174|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9174|002|Z|does NOT have all possible information about this product. This||
9174|003|Z|information does not assure that this product is safe, effective,||
9174|004|Z|or appropriate for you. This information is not individual||
9174|005|Z|medical advice and does not substitute for the advice of your||
9174|006|Z|health care professional. Always ask your health care||
9174|007|Z|professional for complete information about this product and your||
9174|008|Z|specific health needs.||
9174|009|B|||
9174|010|T|CALCITONIN SALMON - INJECTION||
9174|011|F|(KAL-si-TOE-nin)||
9174|012|B|||
9174|013|C|COMMON BRAND NAME(S): Calcimar, Miacalcin||
9174|014|B|||
9174|015|U|USES:  This medication is used to treat certain bone problems||
9174|016|U|(such as Paget's disease, postmenopausal osteoporosis) and to||
9174|017|U|reduce high blood levels of calcium. Calcitonin is a man-made||
9174|018|U|hormone that works by slowing bone loss and maintaining normal||
9174|019|U|calcium levels in the blood. It may also help to reduce bone pain||
9174|020|U|in people who have Paget's disease.||
9174|021|B|||
9174|022|H|HOW TO USE:  Inject this medication under the skin or into a||
9174|023|H|muscle as directed by your doctor. If you are using more than 2||
9174|024|H|milliliters of the medication at a time, it is recommended that||
9174|025|H|you inject the medication into a muscle.||
9174|026|H|   The dosage is based on your medical condition and response to||
9174|027|H|treatment. For the treatment of high calcium, the dosage is also||
9174|028|H|based on weight. It is recommended to use this medication at the||
9174|029|H|lowest effective dose and for the shortest amount of time to||
9174|030|H|treat your condition. Patients treated long-term with this||
9174|031|H|medication have shown a rare risk of developing cancer. Discuss||
9174|032|H|with your doctor the benefits and risks of long term treatment||
9174|033|H|with this medication.||
9174|034|H|   Learn all preparation and usage instructions from your health||
9174|035|H|care professional. Before using, check this product for particles||
9174|036|H|or discoloration. If either is present, do not use the liquid.||
9174|037|H|Before injecting each dose, clean the skin you are going to||
9174|038|H|inject into (the injection site) with rubbing alcohol. Change the||
9174|039|H|injection site each time to lessen injury under the skin. Learn||
9174|040|H|how to store and discard medical supplies safely.||
9174|041|H|   Use this medication regularly to get the most benefit from it.||
9174|042|H|To help you remember, use it at the same time(s) each day. If you||
9174|043|H|are using this medication on a schedule other than every day||
9174|044|H|(such as every other day), it may help to mark your calendar with||
9174|045|H|a reminder.||
9174|046|H|   Tell your doctor if your condition lasts or gets worse.||
9174|047|B|||
9174|048|S|SIDE EFFECTS:  (See also How to Use section).||
9174|049|S|   Nausea, abdominal pain, diarrhea, vomiting, or flushing may||
9174|050|S|occur. Using this medication at bedtime may help to decrease||
9174|051|S|these side effects. Swelling/redness at injection site, a salty||
9174|052|S|taste in mouth, increased urination, or loss of appetite may also||
9174|053|S|occur. If any of these effects last or get worse, tell your||
9174|054|S|doctor or pharmacist promptly.||
9174|055|S|   Remember that this medication has been prescribed because your||
9174|056|S|doctor has judged that the benefit to you is greater than the||
9174|057|S|risk of side effects. Many people using this medication do not||
9174|058|S|have serious side effects.||
9174|059|S|   Tell your doctor right away if you have any serious side||
9174|060|S|effects, including: eye pain, swelling ankles/feet, muscle||
9174|061|S|cramps/spasms, numbness/tingling of the arms/legs.||
9174|062|S|   Get medical help right away if you have any very serious side||
9174|063|S|effects, including: seizures.||
9174|064|S|   A very serious allergic reaction to this drug is rare.||
9174|065|S|However, get medical help right away if you notice any symptoms||
9174|066|S|of a serious allergic reaction, including: rash, itching/swelling||
9174|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9174|068|S|breathing.||
9174|069|S|   This is not a complete list of possible side effects. If you||
9174|070|S|notice other effects not listed above, contact your doctor or||
9174|071|S|pharmacist.||
9174|072|S|   In the US -||
9174|073|S|   Call your doctor for medical advice about side effects. You||
9174|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9174|075|S|www.fda.gov/medwatch.||
9174|076|S|   In Canada - Call your doctor for medical advice about side||
9174|077|S|effects. You may report side effects to Health Canada at||
9174|078|S|1-866-234-2345.||
9174|079|B|||
9174|080|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
9174|081|P|pharmacist if you are allergic to it; or if you have any other||
9174|082|P|allergies. This product may contain inactive ingredients, which||
9174|083|P|can cause allergic reactions or other problems. Talk to your||
9174|084|P|pharmacist for more details.||
9174|085|P|   Before using this medication, tell your doctor or pharmacist||
9174|086|P|your medical history, especially of: low level of calcium in the||
9174|087|P|blood.||
9174|088|P|   Before having surgery, tell your doctor or dentist about all||
9174|089|P|the products you use (including prescription drugs,||
9174|090|P|nonprescription drugs, and herbal products).||
9174|091|P|   During pregnancy, this medication should be used only when||
9174|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
9174|093|P|   It is unknown if this drug passes into breast milk. Consult||
9174|094|P|your doctor before breastfeeding.||
9174|095|B|||
9174|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9174|097|I|medications work or increase your risk for serious side effects.||
9174|098|I|This document does not contain all possible drug interactions.||
9174|099|I|Keep a list of all the products you use (including||
9174|100|I|prescription/nonprescription drugs and herbal products) and share||
9174|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
9174|102|I|the dosage of any medicines without your doctor's approval.||
9174|103|I|   A product that may interact with this drug is: lithium.||
9174|104|B|||
9174|105|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9174|106|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9174|107|O|poison control center right away. US residents can call||
9174|108|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9174|109|O|Symptoms of overdose may include: nausea, vomiting.||
9174|110|B|||
9174|111|N|NOTES:  Do not share this medication with others.||
9174|112|N|   Lifestyle changes that help promote healthy bones include||
9174|113|N|increasing weight-bearing exercise, stopping smoking, limiting||
9174|114|N|alcohol, and eating well-balanced meals that contain adequate||
9174|115|N|calcium and vitamin D. Since you may also need to take calcium||
9174|116|N|and vitamin D supplements and make lifestyle changes, consult||
9174|117|N|your doctor for specific advice.||
9174|118|N|   Lab and/or medical tests (such as urine sediment, bone mineral||
9174|119|N|density, calcium levels) may be done while you are using this||
9174|120|N|medication. Keep all medical and lab appointments. Consult your||
9174|121|N|doctor for more details.||
9174|122|B|||
9174|123|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9174|124|D|If it is near the time of the next dose, skip the missed dose.||
9174|125|D|Use your next dose at the regular time. Do not double the dose to||
9174|126|D|catch up.||
9174|127|B|||
9174|128|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep all||
9174|129|R|medications away from children and pets.||
9174|130|R|   Do not flush medications down the toilet or pour them into a||
9174|131|R|drain unless instructed to do so. Properly discard this product||
9174|132|R|when it is expired or no longer needed. Consult your pharmacist||
9174|133|R|or local waste disposal company.||
9174|134|B|||
9174|135|A|Information last revised October 2024.||
9174|136|A|Copyright(c) 2025 First Databank, Inc.||
9174|137|B|||
9177|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9177|002|Z|does NOT have all possible information about this product. This||
9177|003|Z|information does not assure that this product is safe, effective,||
9177|004|Z|or appropriate for you. This information is not individual||
9177|005|Z|medical advice and does not substitute for the advice of your||
9177|006|Z|health care professional. Always ask your health care||
9177|007|Z|professional for complete information about this product and your||
9177|008|Z|specific health needs.||
9177|009|B|||
9177|010|T|LEVOCARNITINE - ORAL||
9177|011|F|(lee-voh-KAR-nih-teen)||
9177|012|B|||
9177|013|C|COMMON BRAND NAME(S): Carnitor||
9177|014|B|||
9177|015|U|USES:  This medication is a diet supplement used to prevent and||
9177|016|U|treat low blood levels of carnitine. Carnitine is a substance||
9177|017|U|made in the body from meat and dairy products. It helps the body||
9177|018|U|use certain chemicals (long-chain fatty acids) for energy and to||
9177|019|U|keep you in good health. Low blood levels of carnitine may occur||
9177|020|U|in people whose bodies cannot properly use carnitine from their||
9177|021|U|diets, people on dialysis due to serious kidney disease, and||
9177|022|U|people being treated with certain drugs (such as valproic acid,||
9177|023|U|zidovudine). Carnitine levels that are too low can cause liver,||
9177|024|U|heart, and muscle problems.||
9177|025|U|   Carnitine comes in 2 forms, this medication (levocarnitine)||
9177|026|U|and D-carnitine. An over-the-counter product called vitamin Bt||
9177|027|U|contains a mixture of levocarnitine and D-carnitine. Vitamin Bt||
9177|028|U|should not be used to treat serious carnitine deficiency since it||
9177|029|U|can interfere with the body's use of levocarnitine. Do not use||
9177|030|U|levocarnitine to treat serious carnitine deficiency unless||
9177|031|U|prescribed by your doctor.||
9177|032|U|   The form of levocarnitine taken by mouth is not recommended||
9177|033|U|for treating people on dialysis due to serious kidney disease.||
9177|034|U|The injectable form should be used for this treatment. Consult||
9177|035|U|your doctor for details.||
9177|036|U|   Some supplement products have been found to contain possibly||
9177|037|U|harmful impurities/additives. Check with your pharmacist for more||
9177|038|U|details about the brand you use.||
9177|039|U|   The FDA has not reviewed this product for safety or||
9177|040|U|effectiveness. Consult your doctor or pharmacist for more||
9177|041|U|details.||
9177|042|B|||
9177|043|H|HOW TO USE:  If you are taking the over-the-counter product, read||
9177|044|H|all directions on the product package before taking this||
9177|045|H|medication. If you have any questions, consult your pharmacist.||
9177|046|H|If your doctor has prescribed this medication, take it as||
9177|047|H|directed.||
9177|048|H|   This medication is best taken with or just after meals to||
9177|049|H|lessen stomach upset. If you are taking more than 1 dose a day,||
9177|050|H|take the doses at evenly spaced times throughout the day (usually||
9177|051|H|at least 3 to 4 hours apart).||
9177|052|H|   If you are taking the liquid form, use a medication-measuring||
9177|053|H|device to carefully measure the prescribed dose. Do not use a||
9177|054|H|household spoon. The liquid form may be taken alone or mixed in a||
9177|055|H|drink or other liquid food. To prevent stomach upset, drink your||
9177|056|H|dose slowly or mix the liquid form with more fluids or liquid||
9177|057|H|food.||
9177|058|H|   Chewable forms of this medication should be chewed thoroughly||
9177|059|H|before swallowing.||
9177|060|H|   The dosage is based on your medical condition and response to||
9177|061|H|treatment. Do not increase your dose or take this medication more||
9177|062|H|often than recommended by your doctor or the package instructions||
9177|063|H|without your doctor's approval. Take this medication regularly in||
9177|064|H|order to get the most benefit from it. To help you remember, take||
9177|065|H|it at the same time(s) each day.||
9177|066|H|   If your condition lasts or gets worse, or if you think you may||
9177|067|H|have a serious medical problem, get medical help right away.||
9177|068|B|||
9177|069|S|SIDE EFFECTS:  Upset stomach, nausea, vomiting, diarrhea,||
9177|070|S|headache, muscle pain/weakness, swelling of hands/lower||
9177|071|S|legs/feet, tingling skin, or body odor ("fishy" smell) may occur.||
9177|072|S|If any of these effects last or get worse, tell your doctor or||
9177|073|S|pharmacist promptly.||
9177|074|S|   If your doctor has prescribed this medication, remember that||
9177|075|S|your doctor has judged that the benefit to you is greater than||
9177|076|S|the risk of side effects. Many people using this medication do||
9177|077|S|not have serious side effects.||
9177|078|S|   Get medical help right away if you have any very serious side||
9177|079|S|effects, including: seizure.||
9177|080|S|   A very serious allergic reaction to this drug is rare.||
9177|081|S|However, get medical help right away if you notice any symptoms||
9177|082|S|of a serious allergic reaction, including: rash, itching/swelling||
9177|083|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9177|084|S|breathing.||
9177|085|S|   This is not a complete list of possible side effects. If you||
9177|086|S|notice other effects not listed above, contact your doctor or||
9177|087|S|pharmacist.||
9177|088|S|   In the US -||
9177|089|S|   Call your doctor for medical advice about side effects. You||
9177|090|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9177|091|S|www.fda.gov/medwatch.||
9177|092|S|   In Canada - Call your doctor for medical advice about side||
9177|093|S|effects. You may report side effects to Health Canada at||
9177|094|S|1-866-234-2345.||
9177|095|B|||
9177|096|P|PRECAUTIONS:  Before taking levocarnitine, tell your doctor or||
9177|097|P|pharmacist if you are allergic to it; or if you have any other||
9177|098|P|allergies. This product may contain inactive ingredients (such as||
9177|099|P|peanut/soy), which can cause allergic reactions or other||
9177|100|P|problems. Talk to your pharmacist for more details.||
9177|101|P|   Before using this medication, tell your doctor or pharmacist||
9177|102|P|your medical history, especially of: kidney disease, seizures.||
9177|103|P|   Liquid preparations of this product may contain sugar and/or||
9177|104|P|alcohol. Caution is advised if you have diabetes, alcohol||
9177|105|P|dependence, or liver disease. Ask your doctor or pharmacist about||
9177|106|P|using this product safely.||
9177|107|P|   During pregnancy, this medication should be used only when||
9177|108|P|clearly needed. Discuss the risks and benefits with your doctor.||
9177|109|P|   It is unknown if this drug passes into breast milk. Consult||
9177|110|P|your doctor before breastfeeding.||
9177|111|B|||
9177|112|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9177|113|I|medications work or increase your risk for serious side effects.||
9177|114|I|This document does not contain all possible drug interactions.||
9177|115|I|Keep a list of all the products you use (including||
9177|116|I|prescription/nonprescription drugs and herbal products) and share||
9177|117|I|it with your doctor and pharmacist. Do not start, stop, or change||
9177|118|I|the dosage of any medicines without your doctor's approval.||
9177|119|B|||
9177|120|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9177|121|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9177|122|O|poison control center right away. US residents can call||
9177|123|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9177|124|B|||
9177|125|N|NOTES:  If your doctor has prescribed this medication, do not||
9177|126|N|share it with others.||
9177|127|N|   Do not change brands or dosage forms of levocarnitine without||
9177|128|N|first checking with your doctor or pharmacist. Different products||
9177|129|N|may not work in the same way.||
9177|130|N|   Lab and/or medical tests (such as serum carnitine levels) may||
9177|131|N|be done while you are taking this medication. Keep all medical||
9177|132|N|and lab appointments. Consult your doctor for more details.||
9177|133|B|||
9177|134|D|MISSED DOSE:  If you are taking this medication on a regular||
9177|135|D|schedule and miss a dose, take it as soon as you remember. If it||
9177|136|D|is near the time of the next dose, skip the missed dose. Take||
9177|137|D|your next dose at the regular time. Do not double the dose to||
9177|138|D|catch up.||
9177|139|B|||
9177|140|R|STORAGE:  Store at room temperature away from light and moisture.||
9177|141|R|Do not store in the bathroom. Do not freeze liquid forms of this||
9177|142|R|medication. Keep all medications away from children and pets.||
9177|143|R|   Do not flush medications down the toilet or pour them into a||
9177|144|R|drain unless instructed to do so. Properly discard this product||
9177|145|R|when it is expired or no longer needed. Consult your pharmacist||
9177|146|R|or local waste disposal company.||
9177|147|B|||
9177|148|A|Information last revised January 2025.||
9177|149|A|Copyright(c) 2025 First Databank, Inc.||
9177|150|B|||
9179|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9179|002|Z|does NOT have all possible information about this product. This||
9179|003|Z|information does not assure that this product is safe, effective,||
9179|004|Z|or appropriate for you. This information is not individual||
9179|005|Z|medical advice and does not substitute for the advice of your||
9179|006|Z|health care professional. Always ask your health care||
9179|007|Z|professional for complete information about this product and your||
9179|008|Z|specific health needs.||
9179|009|B|||
9179|010|T|OXICONAZOLE NITRATE - TOPICAL||
9179|011|F|(ox-ee-CON-uh-zole NYE-trate)||
9179|012|B|||
9179|013|C|COMMON BRAND NAME(S): Oxistat||
9179|014|B|||
9179|015|U|USES:  Oxiconazole is used to treat skin infections such as||
9179|016|U|athlete's foot, jock itch and ringworm. This medication is also||
9179|017|U|used to treat a skin condition known as pityriasis (tinea||
9179|018|U|versicolor), a fungal infection that causes a lightening or||
9179|019|U|darkening of the skin of the neck, chest, arms, or legs.||
9179|020|U|Oxiconazole is an azole antifungal that works by preventing the||
9179|021|U|growth of fungus.||
9179|022|B|||
9179|023|H|HOW TO USE:  Use this medication on the skin only. Clean and||
9179|024|H|thoroughly dry the area to be treated. Apply this medication to||
9179|025|H|the affected skin as directed by your doctor, usually once or||
9179|026|H|twice a day. The dosage and length of treatment depends on the||
9179|027|H|type of infection being treated. Do not apply this more often||
9179|028|H|than prescribed. Your condition will not clear faster, but side||
9179|029|H|effects may be increased.||
9179|030|H|   Apply enough cream or lotion to cover the affected area and||
9179|031|H|some of the surrounding skin. If using the lotion, shake the||
9179|032|H|bottle well just before applying. Use cotton balls or a soft||
9179|033|H|cloth to apply the lotion. After applying this medication, wash||
9179|034|H|your hands. Do not wrap, cover or bandage the area unless||
9179|035|H|directed to do so by your doctor.||
9179|036|H|   Do not apply this medication in the eyes, nose, mouth, or||
9179|037|H|vagina.||
9179|038|H|   Use this medication regularly in order to get the most benefit||
9179|039|H|from it. Remember to use it at the same time(s) each day.||
9179|040|H|   Continue to use this medication until the full prescribed||
9179|041|H|amount is finished, even if symptoms disappear after a few days.||
9179|042|H|Stopping the medication too early may result in a return of the||
9179|043|H|infection.||
9179|044|H|   Tell your doctor if your condition lasts after 2 to 4 weeks of||
9179|045|H|treatment or gets worse at any time.||
9179|046|B|||
9179|047|S|SIDE EFFECTS:  Burning, stinging, swelling, irritation, redness,||
9179|048|S|pimple-like bumps, tenderness, or flaking of the treated skin may||
9179|049|S|occur. If any of these effects last or get worse, tell your||
9179|050|S|doctor or pharmacist promptly.||
9179|051|S|   Remember that this medication has been prescribed because your||
9179|052|S|doctor has judged that the benefit to you is greater than the||
9179|053|S|risk of side effects. Many people using this medication do not||
9179|054|S|have serious side effects.||
9179|055|S|   Tell your doctor right away if you have any serious side||
9179|056|S|effects, including: blistering, oozing, open sores.||
9179|057|S|   A very serious allergic reaction to this drug is rare.||
9179|058|S|However, get medical help right away if you notice any symptoms||
9179|059|S|of a serious allergic reaction, including: rash, itching/swelling||
9179|060|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9179|061|S|breathing.||
9179|062|S|   This is not a complete list of possible side effects. If you||
9179|063|S|notice other effects not listed above, contact your doctor or||
9179|064|S|pharmacist.||
9179|065|S|   In the US -||
9179|066|S|   Call your doctor for medical advice about side effects. You||
9179|067|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9179|068|S|www.fda.gov/medwatch.||
9179|069|S|   In Canada - Call your doctor for medical advice about side||
9179|070|S|effects. You may report side effects to Health Canada at||
9179|071|S|1-866-234-2345.||
9179|072|B|||
9179|073|P|PRECAUTIONS:  Before using oxiconazole, tell your doctor or||
9179|074|P|pharmacist if you are allergic to it; or to other azole||
9179|075|P|antifungals such as clotrimazole, ketoconazole, or miconazole; or||
9179|076|P|if you have any other allergies. This product may contain||
9179|077|P|inactive ingredients, which can cause allergic reactions or other||
9179|078|P|problems. Talk to your pharmacist for more details.||
9179|079|P|   Before using this medication, tell your doctor or pharmacist||
9179|080|P|your medical history.||
9179|081|P|   Before having surgery, tell your doctor or dentist about all||
9179|082|P|the products you use (including prescription drugs,||
9179|083|P|nonprescription drugs, and herbal products).||
9179|084|P|   During pregnancy, this medication should be used only when||
9179|085|P|clearly needed. Discuss the risks and benefits with your doctor.||
9179|086|P|   This medication passes into breast milk. Consult your doctor||
9179|087|P|before breastfeeding.||
9179|088|B|||
9179|089|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9179|090|I|medications work or increase your risk for serious side effects.||
9179|091|I|This document does not contain all possible drug interactions.||
9179|092|I|Keep a list of all the products you use (including||
9179|093|I|prescription/nonprescription drugs and herbal products) and share||
9179|094|I|it with your doctor and pharmacist. Do not start, stop, or change||
9179|095|I|the dosage of any medicines without your doctor's approval.||
9179|096|B|||
9179|097|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9179|098|O|has overdosed and has serious symptoms such as passing out or||
9179|099|O|trouble breathing, call 911. Otherwise, call a poison control||
9179|100|O|center right away. US residents can call 1-800-222-1222. Canada||
9179|101|O|residents can call 1-844-764-7669.||
9179|102|B|||
9179|103|N|NOTES:  Do not share this medication with others.||
9179|104|N|   This medication has been prescribed for your current condition||
9179|105|N|only. Do not use it later for another infection unless your||
9179|106|N|doctor tells you to.||
9179|107|N|   When treating pityriasis, this medication may not cause an||
9179|108|N|immediate return to normal skin color. It may take several months||
9179|109|N|after treatment is completed for your natural skin color to||
9179|110|N|return.||
9179|111|B|||
9179|112|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9179|113|D|If it is near the time of the next dose, skip the missed dose.||
9179|114|D|Use your next dose at the regular time. Do not double the dose to||
9179|115|D|catch up.||
9179|116|B|||
9179|117|R|STORAGE:  Store at room temperature. Keep all medications away||
9179|118|R|from children and pets.||
9179|119|R|   Do not flush medications down the toilet or pour them into a||
9179|120|R|drain unless instructed to do so. Properly discard this product||
9179|121|R|when it is expired or no longer needed. Consult your pharmacist||
9179|122|R|or local waste disposal company.||
9179|123|B|||
9179|124|A|Information last revised May 2024.||
9179|125|A|Copyright(c) 2025 First Databank, Inc.||
9179|126|B|||
9181|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9181|002|Z|does NOT have all possible information about this product. This||
9181|003|Z|information does not assure that this product is safe, effective,||
9181|004|Z|or appropriate for you. This information is not individual||
9181|005|Z|medical advice and does not substitute for the advice of your||
9181|006|Z|health care professional. Always ask your health care||
9181|007|Z|professional for complete information about this product and your||
9181|008|Z|specific health needs.||
9181|009|B|||
9181|010|T|ERYTHROMYCIN/BENZOYL PEROXIDE - TOPICAL||
9181|011|F|(eh-rith-row-MY-sin/BEN-zoh-ill per-OX-ide)||
9181|012|B|||
9181|013|C|COMMON BRAND NAME(S): Benzamycin||
9181|014|B|||
9181|015|U|USES:  This product is used to treat moderate acne. It helps to||
9181|016|U|reduce the number of pimples. This medication is a combination of||
9181|017|U|2 drugs. Erythromycin works by stopping the growth of||
9181|018|U|acne-causing bacteria. It belongs to a class of drugs known as||
9181|019|U|macrolide antibiotics. Benzoyl peroxide also kills acne-causing||
9181|020|U|bacteria and causes the top layer of skin to dry and peel off so||
9181|021|U|that new skin can form. This product also contains alcohol which||
9181|022|U|helps to dry extra oils from the skin.||
9181|023|B|||
9181|024|H|HOW TO USE:  Read the Instructions for Use if available from your||
9181|025|H|pharmacist before you start using this product and each time you||
9181|026|H|get a refill. If you have any questions, ask your doctor or||
9181|027|H|pharmacist.||
9181|028|H|   This medication is for use only on the skin. Before applying,||
9181|029|H|wash the affected areas thoroughly, rinse with warm water, then||
9181|030|H|gently pat dry. Apply a thin layer of this medication as directed||
9181|031|H|by your doctor, usually twice daily (in the morning and in the||
9181|032|H|evening).||
9181|033|H|   Wash your hands after using medication. Avoid getting this||
9181|034|H|medication in your eyes or inside your nose, mouth, or other||
9181|035|H|mucous membranes. If this occurs, rinse thoroughly with water. Do||
9181|036|H|not mix or apply medication near an open flame.||
9181|037|H|   Benzoyl peroxide may bleach hair or colored fabrics (such as||
9181|038|H|clothing, bedding, towels). Use caution when applying this||
9181|039|H|medication near the hairline.||
9181|040|H|   Use this medication regularly to get the most benefit from it.||
9181|041|H|To help you remember, use it at the same times each day. Do not||
9181|042|H|apply large amounts of this medication, use it more often, or use||
9181|043|H|it for longer than prescribed. Your condition will not improve||
9181|044|H|any faster, and your risk of side effects may increase.||
9181|045|H|   Acne usually improves after a few weeks of treatment. However,||
9181|046|H|it may take 2 to 3 months of continued use to notice the full||
9181|047|H|benefit of this product. Tell your doctor if your condition does||
9181|048|H|not get better or if it gets worse.||
9181|049|B|||
9181|050|S|SIDE EFFECTS:  Mild dryness and mild peeling of the top layer of||
9181|051|S|skin is expected. Skin irritation, itching, burning, or redness||
9181|052|S|may occur, especially at the start of treatment as your body||
9181|053|S|adjusts to the medication. Eye irritation and skin discoloration||
9181|054|S|may also occur. If any of these effects last or get worse, stop||
9181|055|S|using this product and tell your doctor or pharmacist promptly.||
9181|056|S|   Remember that this medication has been prescribed because your||
9181|057|S|doctor has judged that the benefit to you is greater than the||
9181|058|S|risk of side effects. Many people using this medication do not||
9181|059|S|have serious side effects.||
9181|060|S|   Rarely, use of this medication for prolonged or repeated||
9181|061|S|periods may result in other types of skin infections (such as||
9181|062|S|fungal infections). Contact your doctor if you notice any unusual||
9181|063|S|skin symptoms or if your condition does not improve.||
9181|064|S|   A very serious allergic reaction to this drug is rare.||
9181|065|S|However, get medical help right away if you notice any symptoms||
9181|066|S|of a serious allergic reaction, including: rash, itching/swelling||
9181|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9181|068|S|breathing.||
9181|069|S|   This is not a complete list of possible side effects. If you||
9181|070|S|notice other effects not listed above, contact your doctor or||
9181|071|S|pharmacist.||
9181|072|S|   In the US -||
9181|073|S|   Call your doctor for medical advice about side effects. You||
9181|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9181|075|S|www.fda.gov/medwatch.||
9181|076|S|   In Canada - Call your doctor for medical advice about side||
9181|077|S|effects. You may report side effects to Health Canada at||
9181|078|S|1-866-234-2345.||
9181|079|B|||
9181|080|P|PRECAUTIONS:  Before using this product, tell your doctor or||
9181|081|P|pharmacist if you are allergic to erythromycin or benzoyl||
9181|082|P|peroxide; or to other macrolide antibiotics (such as||
9181|083|P|azithromycin, clarithromycin); or if you have any other||
9181|084|P|allergies. This product may contain inactive ingredients, which||
9181|085|P|can cause allergic reactions or other problems. Talk to your||
9181|086|P|pharmacist for more details.||
9181|087|P|   Before using this medication, tell your doctor or pharmacist||
9181|088|P|your medical history.||
9181|089|P|   This medication may make you more sensitive to the sun. Limit||
9181|090|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9181|091|P|sunscreen and wear protective clothing when outdoors. Tell your||
9181|092|P|doctor right away if you get sunburned or have skin||
9181|093|P|blisters/redness.||
9181|094|P|   Before having surgery, tell your doctor or dentist about all||
9181|095|P|the products you use (including prescription drugs,||
9181|096|P|nonprescription drugs, and herbal products).||
9181|097|P|   During pregnancy, this medication should be used only when||
9181|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
9181|099|P|   It is unknown if this drug passes into breast milk. Consult||
9181|100|P|your doctor before breastfeeding.||
9181|101|B|||
9181|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9181|103|I|medications work or increase your risk for serious side effects.||
9181|104|I|This document does not contain all possible drug interactions.||
9181|105|I|Keep a list of all the products you use (including||
9181|106|I|prescription/nonprescription drugs and herbal products) and share||
9181|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
9181|108|I|the dosage of any medicines without your doctor's approval.||
9181|109|I|   A product that may interact with this drug is: dapsone used on||
9181|110|I|the skin.||
9181|111|I|   Other skin products (such as cosmetics, medicated soaps,||
9181|112|I|after-shave lotions, products containing alcohol) and other acne||
9181|113|I|skin treatments may increase skin irritation, dryness, and||
9181|114|I|peeling when used with erythromycin/benzoyl peroxide. Ask your||
9181|115|I|doctor or pharmacist about what products are best for you, what||
9181|116|I|products to avoid, and ways you can reduce skin irritation.||
9181|117|B|||
9181|118|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9181|119|O|has overdosed and has serious symptoms such as passing out or||
9181|120|O|trouble breathing, call 911. Otherwise, call a poison control||
9181|121|O|center right away. US residents can call 1-800-222-1222. Canada||
9181|122|O|residents can call 1-844-764-7669.||
9181|123|B|||
9181|124|N|NOTES:  Do not share this medication with others.||
9181|125|N|   For best results, this medication is often used as part of a||
9181|126|N|total skin care program. Follow your doctor's recommendations.||
9181|127|B|||
9181|128|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9181|129|D|If it is near the time of the next dose, skip the missed dose.||
9181|130|D|Use your next dose at the regular time. Do not double the dose to||
9181|131|D|catch up.||
9181|132|B|||
9181|133|R|STORAGE:  Store in the refrigerator. Do not freeze. This||
9181|134|R|medication is flammable. Keep it away from heat and open flame.||
9181|135|R|This medication expires 3 months after it was prepared by the||
9181|136|R|pharmacy. Keep all medications away from children and pets.||
9181|137|R|   Do not flush medications down the toilet or pour them into a||
9181|138|R|drain unless instructed to do so. Properly discard this product||
9181|139|R|when it is expired or no longer needed. Consult your pharmacist||
9181|140|R|or local waste disposal company.||
9181|141|B|||
9181|142|A|Information last revised November 2024.||
9181|143|A|Copyright(c) 2025 First Databank, Inc.||
9181|144|B|||
9185|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9185|002|Z|does NOT have all possible information about this product. This||
9185|003|Z|information does not assure that this product is safe, effective,||
9185|004|Z|or appropriate for you. This information is not individual||
9185|005|Z|medical advice and does not substitute for the advice of your||
9185|006|Z|health care professional. Always ask your health care||
9185|007|Z|professional for complete information about this product and your||
9185|008|Z|specific health needs.||
9185|009|B|||
9185|010|T|FLUTICASONE - TOPICAL||
9185|011|F|(floo-TIK-a-sone)||
9185|012|B|||
9185|013|C|COMMON BRAND NAME(S): Cutivate||
9185|014|B|||
9185|015|U|USES:  This medication is used to treat a variety of skin||
9185|016|U|conditions (such as eczema, psoriasis, rash). Fluticasone reduces||
9185|017|U|swelling (inflammation), itching, and redness. This medication is||
9185|018|U|a medium-strength corticosteroid. It is available in several||
9185|019|U|forms, including cream, ointment, and lotion. Your doctor will||
9185|020|U|choose the type of product based on your skin condition and the||
9185|021|U|area of your body to be treated.||
9185|022|U|   Fluticasone ointment is not recommended for use by children||
9185|023|U|because of the risk of serious side effects.||
9185|024|B|||
9185|025|H|HOW TO USE:  Use this medication on the skin only. However, do||
9185|026|H|not use it on the face, groin, or underarms, or for diaper rash,||
9185|027|H|unless directed to do so by your doctor.||
9185|028|H|   Wash and dry your hands before using. Clean and dry the||
9185|029|H|affected area. Apply a thin film of medication to the affected||
9185|030|H|area and gently rub in as directed by your doctor, usually once||
9185|031|H|or twice daily. Do not bandage, cover, or wrap the area unless||
9185|032|H|directed to do so by your doctor.||
9185|033|H|   Wash your hands after each use, unless you are using this||
9185|034|H|medication to treat the hands. Avoid getting this medication in||
9185|035|H|your eyes because it may worsen or cause glaucoma. Also avoid||
9185|036|H|getting it in your nose or mouth. If medication gets in these||
9185|037|H|areas, rinse with plenty of water.||
9185|038|H|   Use this medication only for the condition prescribed. Do not||
9185|039|H|apply large amounts of this medication, use it more often, or use||
9185|040|H|it for longer than prescribed. Your condition will not improve||
9185|041|H|any faster, and your risk of side effects may increase.||
9185|042|H|   Tell your doctor if your condition does not get better in 2||
9185|043|H|weeks or if it gets worse.||
9185|044|B|||
9185|045|S|SIDE EFFECTS:  Burning, itching, stinging, or dryness may occur||
9185|046|S|when you apply this medication, but usually only lasts a short||
9185|047|S|time. If any of these effects last or get worse, tell your doctor||
9185|048|S|or pharmacist promptly.||
9185|049|S|   Remember that this medication has been prescribed because your||
9185|050|S|doctor has judged that the benefit to you is greater than the||
9185|051|S|risk of side effects. Many people using this medication do not||
9185|052|S|have serious side effects.||
9185|053|S|   Tell your doctor right away if you have any serious side||
9185|054|S|effects, including: stretch marks, skin thinning/discoloration,||
9185|055|S|acne, excessive hair growth, small red bumps on the skin||
9185|056|S|(folliculitis).||
9185|057|S|   Rarely, it is possible this medication will be absorbed from||
9185|058|S|the skin into the bloodstream. This can lead to side effects of||
9185|059|S|too much corticosteroid. These side effects are more likely in||
9185|060|S|children, and in people who use this medication for a long time||
9185|061|S|or over large areas of the skin. Tell your doctor right away if||
9185|062|S|any of the following side effects occur: unusual/extreme||
9185|063|S|tiredness, weight loss, headache, swelling ankles/feet, increased||
9185|064|S|thirst/urination, vision problems.||
9185|065|S|   A very serious allergic reaction to this drug is rare.||
9185|066|S|However, get medical help right away if you notice any symptoms||
9185|067|S|of a serious allergic reaction, including: rash, itching/swelling||
9185|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9185|069|S|breathing.||
9185|070|S|   This is not a complete list of possible side effects. If you||
9185|071|S|notice other effects not listed above, contact your doctor or||
9185|072|S|pharmacist.||
9185|073|S|   In the US -||
9185|074|S|   Call your doctor for medical advice about side effects. You||
9185|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9185|076|S|www.fda.gov/medwatch.||
9185|077|S|   In Canada - Call your doctor for medical advice about side||
9185|078|S|effects. You may report side effects to Health Canada at||
9185|079|S|1-866-234-2345.||
9185|080|B|||
9185|081|P|PRECAUTIONS:  Before using fluticasone, tell your doctor or||
9185|082|P|pharmacist if you are allergic to it; or if you have any other||
9185|083|P|allergies. This product may contain inactive ingredients (such as||
9185|084|P|formaldehyde), which can cause allergic reactions or other||
9185|085|P|problems. Talk to your pharmacist for more details.||
9185|086|P|   Before using this medication, tell your doctor or pharmacist||
9185|087|P|your medical history, especially of: poor blood circulation,||
9185|088|P|diabetes, immune system problems.||
9185|089|P|   Corticosteroids can make skin infections worse and more||
9185|090|P|difficult to treat. Tell your doctor if you have a skin infection||
9185|091|P|or if your condition does not improve.||
9185|092|P|   Rarely, using corticosteroid medications for a long time or||
9185|093|P|over large areas of skin can make it more difficult for your body||
9185|094|P|to respond to physical stress. Before having surgery or emergency||
9185|095|P|treatment, or if you get a serious illness/injury, tell your||
9185|096|P|doctor or dentist that you are using this medication or have used||
9185|097|P|this medication within the past few months.||
9185|098|P|   Though it is unlikely, this medication may temporarily slow||
9185|099|P|down a child's growth if used for a long time. See the doctor||
9185|100|P|regularly so your child's height can be checked.||
9185|101|P|   During pregnancy, this medication should be used only when||
9185|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
9185|103|P|   It is unknown if this medication passes into breast milk.||
9185|104|P|Consult your doctor before breastfeeding.||
9185|105|B|||
9185|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9185|107|I|medications work or increase your risk for serious side effects.||
9185|108|I|This document does not contain all possible drug interactions.||
9185|109|I|Keep a list of all the products you use (including||
9185|110|I|prescription/nonprescription drugs and herbal products) and share||
9185|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
9185|112|I|the dosage of any medicines without your doctor's approval.||
9185|113|B|||
9185|114|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9185|115|O|has overdosed and has serious symptoms such as passing out or||
9185|116|O|trouble breathing, call 911. Otherwise, call a poison control||
9185|117|O|center right away. US residents can call 1-800-222-1222. Canada||
9185|118|O|residents can call 1-844-764-7669.||
9185|119|B|||
9185|120|N|NOTES:  Do not share this medication with others.||
9185|121|N|   This medication has been prescribed for your current condition||
9185|122|N|only. Do not use it later for other skin problems unless told to||
9185|123|N|do so by your doctor. A different medication may be necessary in||
9185|124|N|those cases.||
9185|125|N|   Lab and/or medical tests (such as adrenal gland function) may||
9185|126|N|be done while you are using this medication, especially if you||
9185|127|N|use this drug for a long time or apply it over large areas of the||
9185|128|N|body. Keep all medical and lab appointments. Consult your doctor||
9185|129|N|for more details.||
9185|130|B|||
9185|131|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9185|132|D|If it is near the time of the next dose, skip the missed dose.||
9185|133|D|Use your next dose at the regular time. Do not double the dose to||
9185|134|D|catch up.||
9185|135|B|||
9185|136|R|STORAGE:  Different brands of this medication have different||
9185|137|R|storage needs. Check the product package for instructions on how||
9185|138|R|to store your brand, or ask your pharmacist. Keep all medications||
9185|139|R|away from children and pets.||
9185|140|R|   Do not flush medications down the toilet or pour them into a||
9185|141|R|drain unless instructed to do so. Properly discard this product||
9185|142|R|when it is expired or no longer needed. Consult your pharmacist||
9185|143|R|or local waste disposal company.||
9185|144|B|||
9185|145|A|Information last revised November 2024.||
9185|146|A|Copyright(c) 2025 First Databank, Inc.||
9185|147|B|||
9186|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9186|002|Z|does NOT have all possible information about this product. This||
9186|003|Z|information does not assure that this product is safe, effective,||
9186|004|Z|or appropriate for you. This information is not individual||
9186|005|Z|medical advice and does not substitute for the advice of your||
9186|006|Z|health care professional. Always ask your health care||
9186|007|Z|professional for complete information about this product and your||
9186|008|Z|specific health needs.||
9186|009|B|||
9186|010|T|KETOROLAC 0.5% SOLUTION - OPHTHALMIC||
9186|011|F|(KEE-toe-ROLE-ak)||
9186|012|B|||
9186|013|C|COMMON BRAND NAME(S): Acular||
9186|014|B|||
9186|015|U|USES:  This medication is used to temporarily relieve itching||
9186|016|U|eyes caused by seasonal allergies. It is also used to prevent and||
9186|017|U|treat eye swelling due to a certain type of eye surgery (cataract||
9186|018|U|removal). Ketorolac belongs to a class of drugs known as||
9186|019|U|nonsteroidal anti-inflammatory drugs (NSAIDs). It works by||
9186|020|U|blocking certain natural substances in your body to reduce pain||
9186|021|U|and swelling.||
9186|022|B|||
9186|023|H|HOW TO USE:  Use this medication to the affected eye(s) as||
9186|024|H|directed by your doctor, usually 4 times daily.||
9186|025|H|   To apply eye drops, wash your hands first. To avoid||
9186|026|H|contamination, do not touch the dropper tip or let it touch your||
9186|027|H|eye or any other surface.||
9186|028|H|   This medication should not be used while wearing contact||
9186|029|H|lenses. Consult your doctor or pharmacist for details.||
9186|030|H|   Tilt your head back, look upward, and pull down the lower||
9186|031|H|eyelid to make a pouch. Hold the dropper directly over your eye||
9186|032|H|and place one drop into the pouch. Look downward and gently close||
9186|033|H|your eyes for 1 to 2 minutes. Place one finger at the corner of||
9186|034|H|your eye (near the nose) and apply gentle pressure. This will||
9186|035|H|prevent the medication from draining out. Try not to blink and do||
9186|036|H|not rub your eye. Repeat these steps for your other eye if so||
9186|037|H|directed.||
9186|038|H|   Do not rinse the dropper. Replace the dropper cap after each||
9186|039|H|use.||
9186|040|H|   If you are using another kind of eye medication (such as drops||
9186|041|H|or ointments), wait at least 5 minutes before applying other||
9186|042|H|medications. Use eye drops before eye ointments to allow the eye||
9186|043|H|drops to enter the eye.||
9186|044|H|   Wait several minutes for your vision to clear before driving||
9186|045|H|or operating machinery.||
9186|046|H|   Do not apply this medication more often than prescribed or||
9186|047|H|keep using it for longer than directed by your doctor. This||
9186|048|H|medication is usually for short-term use (2 weeks or less) unless||
9186|049|H|otherwise directed by your doctor. Use of ketorolac eye drops for||
9186|050|H|longer than prescribed may increase the risk of very serious side||
9186|051|H|effects of the eye.||
9186|052|H|   Tell your doctor if your condition lasts or gets worse.||
9186|053|B|||
9186|054|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
9186|055|S|eyes for 1-2 minutes when applied. Eye redness and headache may||
9186|056|S|also occur. If any of these effects last or get worse, tell your||
9186|057|S|doctor or pharmacist promptly.||
9186|058|S|   Remember that this medication has been prescribed because your||
9186|059|S|doctor has judged that the benefit to you is greater than the||
9186|060|S|risk of side effects. Many people using this medication do not||
9186|061|S|have serious side effects.||
9186|062|S|   Tell your doctor right away if you have any serious side||
9186|063|S|effects, including: eye pain/swelling/discharge, vision changes,||
9186|064|S|bleeding inside the eye.||
9186|065|S|   A very serious allergic reaction to this drug is rare.||
9186|066|S|However, get medical help right away if you notice any symptoms||
9186|067|S|of a serious allergic reaction, including: rash, itching/swelling||
9186|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9186|069|S|breathing.||
9186|070|S|   This is not a complete list of possible side effects. If you||
9186|071|S|notice other effects not listed above, contact your doctor or||
9186|072|S|pharmacist.||
9186|073|S|   In the US -||
9186|074|S|   Call your doctor for medical advice about side effects. You||
9186|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9186|076|S|www.fda.gov/medwatch.||
9186|077|S|   In Canada - Call your doctor for medical advice about side||
9186|078|S|effects. You may report side effects to Health Canada at||
9186|079|S|1-866-234-2345.||
9186|080|B|||
9186|081|P|PRECAUTIONS:  Before using ketorolac, tell your doctor or||
9186|082|P|pharmacist if you are allergic to it; or to aspirin, other NSAIDs||
9186|083|P|(such as ibuprofen, celecoxib); or if you have any other||
9186|084|P|allergies. This product may contain inactive ingredients (such as||
9186|085|P|preservatives like benzalkonium chloride), which can cause||
9186|086|P|allergic reactions or other problems. Talk to your pharmacist for||
9186|087|P|more details.||
9186|088|P|   Before using this medication, tell your doctor or pharmacist||
9186|089|P|your medical history, especially of: asthma (including a history||
9186|090|P|of worsening breathing after taking aspirin or other NSAIDs),||
9186|091|P|bleeding problems, previous eye surgery, other eye problems (such||
9186|092|P|as dry eye syndrome, corneal problems), diabetes, rheumatoid||
9186|093|P|arthritis, nasal polyps.||
9186|094|P|   After you apply this drug, your vision may become temporarily||
9186|095|P|blurred or unstable. Do not drive, use machinery, or do anything||
9186|096|P|that needs clear vision until you can do it safely.||
9186|097|P|   Before having surgery, tell your doctor or dentist about all||
9186|098|P|the products you use (including prescription drugs,||
9186|099|P|nonprescription drugs, and herbal products).||
9186|100|P|   During pregnancy, this medication should be used only when||
9186|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
9186|102|P|   It is unknown if this drug passes into breast milk, but it is||
9186|103|P|unlikely to harm a nursing infant. Consult your doctor before||
9186|104|P|breastfeeding.||
9186|105|B|||
9186|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9186|107|I|medications work or increase your risk for serious side effects.||
9186|108|I|This document does not contain all possible drug interactions.||
9186|109|I|Keep a list of all the products you use (including||
9186|110|I|prescription/nonprescription drugs and herbal products) and share||
9186|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
9186|112|I|the dosage of any medicines without your doctor's approval.||
9186|113|I|   Some products that may interact with this drug are:||
9186|114|I|corticosteroid drugs (such as prednisone), other eye medications||
9186|115|I|(such as corticosteroid eye drops).||
9186|116|I|   This medication may increase the risk of bleeding when used||
9186|117|I|with other drugs that also may cause bleeding. Examples include||
9186|118|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
9186|119|I|dabigatran/enoxaparin/warfarin, among others.||
9186|120|I|   Check all prescription and nonprescription medicine labels||
9186|121|I|carefully since many medications contain pain relievers/fever||
9186|122|I|reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These||
9186|123|I|drugs are similar to ketorolac and may increase your risk of side||
9186|124|I|effects if taken together. However, if your doctor has told you||
9186|125|I|to take low-dose aspirin to prevent heart attack or stroke||
9186|126|I|(usually 81-162 milligrams a day), you should keep taking the||
9186|127|I|aspirin unless your doctor tells you not to. Ask your doctor or||
9186|128|I|pharmacist for more details.||
9186|129|B|||
9186|130|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9186|131|O|has overdosed and has serious symptoms such as passing out or||
9186|132|O|trouble breathing, call 911. Otherwise, call a poison control||
9186|133|O|center right away. US residents can call 1-800-222-1222. Canada||
9186|134|O|residents can call 1-844-764-7669.||
9186|135|B|||
9186|136|N|NOTES:  Do not share this medication with others.||
9186|137|N|   This medication has been prescribed for your current condition||
9186|138|N|only. Do not use it later for another eye condition unless told||
9186|139|N|to do so by your doctor. A different medication may be necessary||
9186|140|N|in those cases.||
9186|141|N|   If you suffer from allergies, try to minimize exposure to||
9186|142|N|pollen and other irritants. Use of cold compresses over the eyes||
9186|143|N|and lubricating eye drops can also help relieve symptoms. Ask||
9186|144|N|your doctor or pharmacist for more information.||
9186|145|B|||
9186|146|D|MISSED DOSE:  If you have been instructed to use this drug on a||
9186|147|D|regular schedule, use the missed dose as soon as you remember. If||
9186|148|D|it is near the time of the next dose, skip the missed dose. Use||
9186|149|D|your next dose at the regular time. Do not double the dose to||
9186|150|D|catch up.||
9186|151|B|||
9186|152|R|STORAGE:  Store at room temperature away from light. Discard this||
9186|153|R|medication if the solution changes color, becomes cloudy, or||
9186|154|R|develops particles. Keep all medications away from children and||
9186|155|R|pets.||
9186|156|R|   Do not flush medications down the toilet or pour them into a||
9186|157|R|drain unless instructed to do so. Properly discard this product||
9186|158|R|when it is expired or no longer needed. Consult your pharmacist||
9186|159|R|or local waste disposal company.||
9186|160|B|||
9186|161|A|Information last revised May 2024.||
9186|162|A|Copyright(c) 2025 First Databank, Inc.||
9186|163|B|||
9187|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9187|002|Z|does NOT have all possible information about this product. This||
9187|003|Z|information does not assure that this product is safe, effective,||
9187|004|Z|or appropriate for you. This information is not individual||
9187|005|Z|medical advice and does not substitute for the advice of your||
9187|006|Z|health care professional. Always ask your health care||
9187|007|Z|professional for complete information about this product and your||
9187|008|Z|specific health needs.||
9187|009|B|||
9187|010|T|TIOPRONIN - ORAL||
9187|011|F|(tie-oh-PRO-nin)||
9187|012|B|||
9187|013|C|COMMON BRAND NAME(S): Thiola||
9187|014|B|||
9187|015|U|USES:  This medication is used to prevent kidney stones in people||
9187|016|U|with a certain inherited disorder (cystinuria). Cystinuria occurs||
9187|017|U|when there is too much of a certain natural substance (the amino||
9187|018|U|acid cystine) in the urine, leading to formation of kidney||
9187|019|U|stones. Tiopronin works by making cystine more dissolvable in the||
9187|020|U|urine.||
9187|021|U|   This medication should be used in combination with other||
9187|022|U|methods to prevent kidney stones (such as drinking plenty of||
9187|023|U|water, taking alkali treatment, following a special diet).||
9187|024|B|||
9187|025|H|HOW TO USE:  Take this medication by mouth 1 hour before or 2||
9187|026|H|hours after meals as directed by your doctor, usually 3 times||
9187|027|H|daily.||
9187|028|H|   Continue to drink plenty of water and to take the alkali||
9187|029|H|medication as directed by your doctor. Closely follow the diet||
9187|030|H|recommended by your doctor.||
9187|031|H|   The dosage is based on your medical condition, lab tests, and||
9187|032|H|response to treatment. Children's dosage may be based on weight.||
9187|033|H|   Use this medication regularly to get the most benefit from it.||
9187|034|H|To help you remember, take it at the same times each day.||
9187|035|H|   Do not increase your dose or use this drug more often or for||
9187|036|H|longer than prescribed. Your condition will not improve any||
9187|037|H|faster, and your risk of side effects will increase.||
9187|038|H|   Tell your doctor if your condition gets worse.||
9187|039|B|||
9187|040|S|SIDE EFFECTS:  Nausea, diarrhea, or decreased sense of||
9187|041|S|taste/smell may occur. If any of these effects last or get worse,||
9187|042|S|tell your doctor or pharmacist promptly.||
9187|043|S|   Remember that this medication has been prescribed because your||
9187|044|S|doctor has judged that the benefit to you is greater than the||
9187|045|S|risk of side effects. Many people using this medication do not||
9187|046|S|have serious side effects.||
9187|047|S|   Tell your doctor right away if you have any serious side||
9187|048|S|effects, including: muscle/joint pain, swollen lymph nodes, loss||
9187|049|S|of appetite, tiredness, signs of kidney problems (such as change||
9187|050|S|in the amount of urine, painful urination, cloudy/bloody/frothy||
9187|051|S|urine), muscle weakness.||
9187|052|S|   A very serious allergic reaction to this drug is rare.||
9187|053|S|However, get medical help right away if you notice any symptoms||
9187|054|S|of a serious allergic reaction, including: rash, itching/swelling||
9187|055|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9187|056|S|breathing.||
9187|057|S|   This is not a complete list of possible side effects. If you||
9187|058|S|notice other effects not listed above, contact your doctor or||
9187|059|S|pharmacist.||
9187|060|S|   In the US -||
9187|061|S|   Call your doctor for medical advice about side effects. You||
9187|062|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9187|063|S|www.fda.gov/medwatch.||
9187|064|S|   In Canada - Call your doctor for medical advice about side||
9187|065|S|effects. You may report side effects to Health Canada at||
9187|066|S|1-866-234-2345.||
9187|067|B|||
9187|068|P|PRECAUTIONS:  Before taking tiopronin, tell your doctor or||
9187|069|P|pharmacist if you are allergic to it; or if you have any other||
9187|070|P|allergies. This product may contain inactive ingredients, which||
9187|071|P|can cause allergic reactions or other problems. Talk to your||
9187|072|P|pharmacist for more details.||
9187|073|P|   Before using this medication, tell your doctor or pharmacist||
9187|074|P|your medical history, especially of: liver disease, kidney||
9187|075|P|disease.||
9187|076|P|   Before having surgery, tell your doctor or dentist about all||
9187|077|P|the products you use (including prescription drugs,||
9187|078|P|nonprescription drugs, and herbal products).||
9187|079|P|   During pregnancy, this medication should be used only when||
9187|080|P|clearly needed. Discuss the risks and benefits with your doctor.||
9187|081|P|   It is unknown if this medication passes into breast milk.||
9187|082|P|Because of possible risk to the infant, breastfeeding is not||
9187|083|P|recommended while using this medication. Consult your doctor||
9187|084|P|before breastfeeding.||
9187|085|B|||
9187|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9187|087|I|medications work or increase your risk for serious side effects.||
9187|088|I|This document does not contain all possible drug interactions.||
9187|089|I|Keep a list of all the products you use (including||
9187|090|I|prescription/nonprescription drugs and herbal products) and share||
9187|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
9187|092|I|the dosage of any medicines without your doctor's approval.||
9187|093|B|||
9187|094|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9187|095|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9187|096|O|poison control center right away. US residents can call||
9187|097|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9187|098|B|||
9187|099|N|NOTES:  Do not share this medication with others.||
9187|100|N|   Lab and/or medical tests (such as urine cystine levels, urine||
9187|101|N|tests) should be done while you are taking this medication. Keep||
9187|102|N|all medical and lab appointments. Consult your doctor for more||
9187|103|N|details.||
9187|104|B|||
9187|105|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9187|106|D|remember. If it is near the time of the next dose, skip the||
9187|107|D|missed dose. Take your next dose at the regular time. Do not||
9187|108|D|double the dose to catch up.||
9187|109|B|||
9187|110|R|STORAGE:  Store at room temperature away from light and moisture.||
9187|111|R|Do not store in the bathroom. Keep all medications away from||
9187|112|R|children and pets.||
9187|113|R|   Do not flush medications down the toilet or pour them into a||
9187|114|R|drain unless instructed to do so. Properly discard this product||
9187|115|R|when it is expired or no longer needed. Consult your pharmacist||
9187|116|R|or local waste disposal company.||
9187|117|B|||
9187|118|A|Information last revised August 2024.||
9187|119|A|Copyright(c) 2025 First Databank, Inc.||
9187|120|B|||
9190|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9190|002|Z|does NOT have all possible information about this product. This||
9190|003|Z|information does not assure that this product is safe, effective,||
9190|004|Z|or appropriate for you. This information is not individual||
9190|005|Z|medical advice and does not substitute for the advice of your||
9190|006|Z|health care professional. Always ask your health care||
9190|007|Z|professional for complete information about this product and your||
9190|008|Z|specific health needs.||
9190|009|B|||
9190|010|T|NALOXONE - INJECTION||
9190|011|F|(nal-OX-one)||
9190|012|B|||
9190|013|U|USES:  Naloxone is used for the emergency treatment of known or||
9190|014|U|suspected opioid overdose. Serious opioid overdose symptoms may||
9190|015|U|include unusual sleepiness, unusual difficulty waking up, or||
9190|016|U|breathing problems (ranging from slow/shallow breathing to no||
9190|017|U|breathing). Other symptoms of overdose may include very small||
9190|018|U|"pinpoint" pupils, slow heartbeat, or low blood pressure. If||
9190|019|U|someone has serious overdose symptoms but you are not sure if the||
9190|020|U|symptoms are due to opioid overdose, give naloxone right away||
9190|021|U|anyway, since lasting slow/shallow breathing may cause permanent||
9190|022|U|damage to the brain or death. Since symptoms of opioid overdose||
9190|023|U|may return after treatment, be sure to get medical help right||
9190|024|U|away after giving the first dose of naloxone.||
9190|025|U|   Naloxone belongs to a class of drugs known as opioid||
9190|026|U|antagonists. It works by blocking the effects of the opioid in||
9190|027|U|the brain.||
9190|028|B|||
9190|029|H|HOW TO USE:  Read the Instructions for Use if available from your||
9190|030|H|pharmacist before you start using naloxone and each time you get||
9190|031|H|a refill. Ask your health care professional how to prepare and||
9190|032|H|use this medication. If you have any questions, ask your doctor||
9190|033|H|or pharmacist.||
9190|034|H|   Inject this medication into a muscle or under the skin as||
9190|035|H|directed by your doctor. It may also be given by injection into a||
9190|036|H|vein by a health care professional. The dosage is based on your||
9190|037|H|medical condition and response to treatment. Children's dosage is||
9190|038|H|also based on weight.||
9190|039|H|   If you are using this medication at home, learn all||
9190|040|H|preparation and usage instructions from your health care||
9190|041|H|professional and the product package. Before using, check this||
9190|042|H|product for particles or discoloration. If either is present, do||
9190|043|H|not use the liquid. Learn how to store and discard medical||
9190|044|H|supplies safely. Close family and household members should know||
9190|045|H|the symptoms of an opioid overdose and be instructed on how to||
9190|046|H|give naloxone if needed. Opioid overdose should be treated right||
9190|047|H|away to prevent serious effects (such as brain damage). See also||
9190|048|H|Uses section.||
9190|049|H|   The effects of this medication are rapid but not long-lasting.||
9190|050|H|After giving naloxone, get medical help right away, even if the||
9190|051|H|person wakes up. If symptoms return after giving an injection,||
9190|052|H|give another naloxone injection every 2 to 3 minutes. Continue to||
9190|053|H|closely watch the person until emergency help is received. Tell||
9190|054|H|the healthcare professional that you have given an injection of||
9190|055|H|naloxone.||
9190|056|B|||
9190|057|S|SIDE EFFECTS:  Remember that this medication has been prescribed||
9190|058|S|because your doctor has judged that the benefit to you is greater||
9190|059|S|than the risk of side effects. Many people using this medication||
9190|060|S|do not have serious side effects.||
9190|061|S|   In someone who has been using an opioid regularly, withdrawal||
9190|062|S|symptoms can happen suddenly after receiving this medication.||
9190|063|S|Withdrawal symptoms may include body aches, fever, sweating,||
9190|064|S|watering eyes, runny nose, sneezing, goose bumps, yawning,||
9190|065|S|weakness, shivering/trembling, nervousness, restlessness,||
9190|066|S|diarrhea, nausea/vomiting, stomach cramps, increased blood||
9190|067|S|pressure, fast heartbeat. In babies younger than 4 weeks who have||
9190|068|S|been receiving an opioid regularly, sudden opioid withdrawal may||
9190|069|S|be life-threatening if not treated the right way. Symptoms in||
9190|070|S|babies may include seizures, crying more than usual, and muscle||
9190|071|S|twitching/spasms.||
9190|072|S|   A very serious allergic reaction to this drug is rare.||
9190|073|S|However, get medical help right away if you notice any symptoms||
9190|074|S|of a serious allergic reaction, including: rash, itching/swelling||
9190|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9190|076|S|breathing.||
9190|077|S|   This is not a complete list of possible side effects. If you||
9190|078|S|notice other effects not listed above, contact your doctor or||
9190|079|S|pharmacist.||
9190|080|S|   In the US -||
9190|081|S|   Call your doctor for medical advice about side effects. You||
9190|082|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9190|083|S|www.fda.gov/medwatch.||
9190|084|S|   In Canada - Call your doctor for medical advice about side||
9190|085|S|effects. You may report side effects to Health Canada at||
9190|086|S|1-866-234-2345.||
9190|087|B|||
9190|088|P|PRECAUTIONS:  Before using naloxone, tell your doctor or||
9190|089|P|pharmacist if you are allergic to it; or if you have any other||
9190|090|P|allergies. This product may contain inactive ingredients, which||
9190|091|P|can cause allergic reactions or other problems. Talk to your||
9190|092|P|pharmacist for more details.||
9190|093|P|   Before using this medication, tell your doctor or pharmacist||
9190|094|P|your medical history, especially of: heart problems (such as||
9190|095|P|irregular heartbeat, previous heart attack).||
9190|096|P|   Before having surgery, tell your doctor or dentist about all||
9190|097|P|the products you use (including prescription drugs,||
9190|098|P|nonprescription drugs, and herbal products).||
9190|099|P|   Since untreated opioid overdose can harm both a pregnant woman||
9190|100|P|and her unborn baby, this medication may be used during||
9190|101|P|pregnancy. However, naloxone may cause opioid withdrawal in your||
9190|102|P|unborn baby. Tell your doctor right away that you used this||
9190|103|P|medication, so you and your unborn baby can be monitored. Ask||
9190|104|P|your doctor for details.||
9190|105|P|   It is unknown if this medication passes into breast milk.||
9190|106|P|However, it is unlikely to harm a nursing infant. Consult your||
9190|107|P|doctor before breastfeeding.||
9190|108|B|||
9190|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9190|110|I|medications work or increase your risk for serious side effects.||
9190|111|I|This document does not contain all possible drug interactions.||
9190|112|I|Keep a list of all the products you use (including||
9190|113|I|prescription/nonprescription drugs and herbal products) and share||
9190|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
9190|115|I|the dosage of any medicines without your doctor's approval.||
9190|116|B|||
9190|117|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9190|118|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9190|119|O|poison control center right away. US residents can call||
9190|120|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9190|121|B|||
9190|122|N|NOTES:  Ask your doctor or pharmacist about ways to prevent||
9190|123|N|opioid overdose. Teach your close family or household members the||
9190|124|N|signs and symptoms of an opioid overdose and tell them where you||
9190|125|N|keep this medication.||
9190|126|B|||
9190|127|D|MISSED DOSE:  Not applicable.||
9190|128|B|||
9190|129|R|STORAGE:  Store at room temperature. Keep the medication in the||
9190|130|R|original carton to protect from light. Keep all medications away||
9190|131|R|from children and pets.||
9190|132|R|   Do not flush medications down the toilet or pour them into a||
9190|133|R|drain unless instructed to do so. Properly discard this product||
9190|134|R|when it is expired or no longer needed. Consult your pharmacist||
9190|135|R|or local waste disposal company.||
9190|136|B|||
9190|137|A|Information last revised September 2025.||
9190|138|A|Copyright(c) 2025 First Databank, Inc.||
9190|139|B|||
9193|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9193|002|Z|does NOT have all possible information about this product. This||
9193|003|Z|information does not assure that this product is safe, effective,||
9193|004|Z|or appropriate for you. This information is not individual||
9193|005|Z|medical advice and does not substitute for the advice of your||
9193|006|Z|health care professional. Always ask your health care||
9193|007|Z|professional for complete information about this product and your||
9193|008|Z|specific health needs.||
9193|009|B|||
9193|010|T|PODOFILOX SOLUTION - TOPICAL||
9193|011|F|(poh-DOFF-ih-lox)||
9193|012|B|||
9193|013|C|COMMON BRAND NAME(S): Condylox||
9193|014|B|||
9193|015|U|USES:  Podofilox solution is used to treat warts on the outside||
9193|016|U|of the genitals. It stops the growth of the wart and the wart||
9193|017|U|eventually falls off. Podofilox belongs to a group of drugs||
9193|018|U|called antimitotics.||
9193|019|B|||
9193|020|V|OTHER USES:  This section contains uses of this drug that are not||
9193|021|V|listed in the approved professional labeling for the drug but||
9193|022|V|that may be prescribed by your health care professional. Use this||
9193|023|V|drug for a condition that is listed in this section only if it||
9193|024|V|has been so prescribed by your health care professional.||
9193|025|V|   This drug may also be used for a skin infection called||
9193|026|V|molluscum contagiosum.||
9193|027|B|||
9193|028|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9193|029|H|from your pharmacist before you start using podofilox solution||
9193|030|H|and each time you get a refill. If you have any questions, ask||
9193|031|H|your doctor or pharmacist.||
9193|032|H|   This medication is for use on the skin only. Only apply this||
9193|033|H|medication to the genital warts that your doctor has identified||
9193|034|H|for you. Do not use this medication on warts around the anus or||
9193|035|H|on the mucous membranes (such as in the urethra, rectum, and||
9193|036|H|vagina), inside your body, or on any other skin growths.||
9193|037|H|   Use this medication usually twice daily (once in the morning||
9193|038|H|and once in the evening, every 12 hours), for 3 days in a row,||
9193|039|H|followed by no treatment for the next 4 days. If the warts do not||
9193|040|H|go away, you may repeat this 7-day cycle up to a total of 4||
9193|041|H|treatment weeks in a row. Follow your doctor's directions||
9193|042|H|exactly.||
9193|043|H|   First wash the area to be treated with soap and water, and dry||
9193|044|H|thoroughly. Use an applicator that comes with this product, dip||
9193|045|H|it into the solution just enough to wet it, but not so much that||
9193|046|H|solution is dripping from the tip. Apply this medication only to||
9193|047|H|the warts your doctor has directed you to treat. Do not apply it||
9193|048|H|to the area surrounding the warts. It may help to use a hand||
9193|049|H|mirror.||
9193|050|H|   For warts within skin folds, pull the skin fold open and apply||
9193|051|H|the medication. Let the medication dry before allowing the skin||
9193|052|H|folds around the warts to return to their normal position.||
9193|053|H|   Only use the applicator once. Do not dip it into the solution||
9193|054|H|again. Throw it away in a safe place after use. Wash your hands||
9193|055|H|with soap and water after each application.||
9193|056|H|   Do not cover the treated area with bandages or other||
9193|057|H|waterproof dressings. Covering the area with cotton gauze, or||
9193|058|H|cotton underwear for the genital area, is permitted.||
9193|059|H|   Use this medication regularly to get the most benefit from it.||
9193|060|H|To help you remember, mark your calendar with a reminder.||
9193|061|H|   Avoid getting this medication in the eyes/nose/mouth, on||
9193|062|H|healthy skin, or on other areas as mentioned above. If the||
9193|063|H|medication gets on healthy skin, wipe it off right away and wash||
9193|064|H|the area thoroughly with soap and water and rinse off. If the||
9193|065|H|medication gets in your eyes, nose, or mouth, flush the area with||
9193|066|H|plenty of water for 15 minutes and contact your doctor.||
9193|067|H|   Do not apply a large amount of this medication or apply it to||
9193|068|H|a large area. Ask your doctor or pharmacist for details. Do not||
9193|069|H|use it more often or for longer than prescribed. Your condition||
9193|070|H|will not improve any faster, and your risk of side effects will||
9193|071|H|increase.||
9193|072|H|   Tell your doctor if your condition lasts after 4 weeks of||
9193|073|H|treatment, or if it gets worse, or if new growths appear during||
9193|074|H|treatment. Genital warts often return after treatment.||
9193|075|B|||
9193|076|S|SIDE EFFECTS:  Redness, itching, burning, and pain may occur in||
9193|077|S|the treated area. If any of these effects last or get worse, or||
9193|078|S|if you have bleeding, severe swelling, or severe pain, wash the||
9193|079|S|medication off with soap and water. Stop using this medication||
9193|080|S|and tell your doctor or pharmacist promptly.||
9193|081|S|   Remember that this medication has been prescribed because your||
9193|082|S|doctor has judged that the benefit to you is greater than the||
9193|083|S|risk of side effects. Many people using this medication do not||
9193|084|S|have serious side effects.||
9193|085|S|   A very serious allergic reaction to this drug is rare.||
9193|086|S|However, get medical help right away if you notice any symptoms||
9193|087|S|of a serious allergic reaction, including: rash, itching/swelling||
9193|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9193|089|S|breathing.||
9193|090|S|   This is not a complete list of possible side effects. If you||
9193|091|S|notice other effects not listed above, contact your doctor or||
9193|092|S|pharmacist.||
9193|093|S|   In the US -||
9193|094|S|   Call your doctor for medical advice about side effects. You||
9193|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9193|096|S|www.fda.gov/medwatch.||
9193|097|S|   In Canada - Call your doctor for medical advice about side||
9193|098|S|effects. You may report side effects to Health Canada at||
9193|099|S|1-866-234-2345.||
9193|100|B|||
9193|101|P|PRECAUTIONS:  Before using podofilox, tell your doctor or||
9193|102|P|pharmacist if you are allergic to it; or if you have any other||
9193|103|P|allergies. This product may contain inactive ingredients, which||
9193|104|P|can cause allergic reactions or other problems. Talk to your||
9193|105|P|pharmacist for more details.||
9193|106|P|   Before using this medication, tell your doctor or pharmacist||
9193|107|P|your medical history.||
9193|108|P|   This medication is not a cure for genital warts. These warts||
9193|109|P|are caused by a virus called human papillomavirus (HPV).||
9193|110|P|Podofilox does not destroy the virus. It only helps to remove the||
9193|111|P|warts, but new warts may form or old warts may return, during and||
9193|112|P|after treatment.||
9193|113|P|   Do not have sexual intercourse on the days you have applied||
9193|114|P|this medication.||
9193|115|P|   Genital warts are spread by sexual contact. Condoms (such as||
9193|116|P|latex or polyurethane types) may help prevent the spread of||
9193|117|P|genital warts to your partner. Consult your doctor or pharmacist||
9193|118|P|for more details.||
9193|119|P|   This medication must not be used during pregnancy. It may harm||
9193|120|P|an unborn baby. Discuss the use of reliable forms of birth||
9193|121|P|control with your doctor. If you become pregnant or think you may||
9193|122|P|be pregnant, tell your doctor right away.||
9193|123|P|   It is unknown if this drug passes into breast milk. Consult||
9193|124|P|your doctor before breastfeeding.||
9193|125|B|||
9193|126|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9193|127|I|medications work or increase your risk for serious side effects.||
9193|128|I|This document does not contain all possible drug interactions.||
9193|129|I|Keep a list of all the products you use (including||
9193|130|I|prescription/nonprescription drugs and herbal products) and share||
9193|131|I|it with your doctor and pharmacist. Do not start, stop, or change||
9193|132|I|the dosage of any medicines without your doctor's approval.||
9193|133|B|||
9193|134|O|OVERDOSE:  This product may be harmful if swallowed. If too much||
9193|135|O|of this medication is applied to the skin, wash it off with||
9193|136|O|plenty of soap and water. If someone has overdosed and has||
9193|137|O|serious symptoms such as passing out or trouble breathing, call||
9193|138|O|911. Otherwise, call a poison control center right away. US||
9193|139|O|residents can call 1-800-222-1222. Canada residents can call||
9193|140|O|1-844-764-7669. Symptoms of overdose may include: nausea,||
9193|141|O|vomiting, diarrhea, trouble breathing, seizures.||
9193|142|B|||
9193|143|N|NOTES:  Do not share this medication with others.||
9193|144|N|   Keep all medical appointments.||
9193|145|B|||
9193|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9193|147|D|If it is near the time of the next dose, skip the missed dose.||
9193|148|D|Use your next dose at the regular time. Do not double the dose to||
9193|149|D|catch up.||
9193|150|B|||
9193|151|R|STORAGE:  Store at room temperature away from high heat and open||
9193|152|R|flame. Do not freeze. Keep all medications away from children and||
9193|153|R|pets.||
9193|154|R|   Do not flush medications down the toilet or pour them into a||
9193|155|R|drain unless instructed to do so. Properly discard this product||
9193|156|R|when it is expired or no longer needed. Consult your pharmacist||
9193|157|R|or local waste disposal company.||
9193|158|B|||
9193|159|A|Information last revised October 2024.||
9193|160|A|Copyright(c) 2025 First Databank, Inc.||
9193|161|B|||
9198|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9198|002|Z|does NOT have all possible information about this product. This||
9198|003|Z|information does not assure that this product is safe, effective,||
9198|004|Z|or appropriate for you. This information is not individual||
9198|005|Z|medical advice and does not substitute for the advice of your||
9198|006|Z|health care professional. Always ask your health care||
9198|007|Z|professional for complete information about this product and your||
9198|008|Z|specific health needs.||
9198|009|B|||
9198|010|T|HYDROQUINONE - TOPICAL||
9198|011|F|(hi-dro-KWIN-own)||
9198|012|B|||
9198|013|C|COMMON BRAND NAME(S): Eldoquin, Epiquin Micro, Lustra, Melanex||
9198|014|B|||
9198|015|U|USES:  Hydroquinone is used to lighten the dark patches of skin||
9198|016|U|(also called hyperpigmentation, melasma, "liver spots," "age||
9198|017|U|spots," freckles) caused by pregnancy, birth control pills,||
9198|018|U|hormone medicine, or injury to the skin.||
9198|019|U|   This medicine works by blocking the process in the skin that||
9198|020|U|leads to discoloration.||
9198|021|B|||
9198|022|H|HOW TO USE:  Follow all directions on the product package, or use||
9198|023|H|as directed by your doctor. Before using, apply a small amount of||
9198|024|H|this medicine to an area of unbroken skin, and check the area||
9198|025|H|within 24 hours for any serious side effects. If the test area is||
9198|026|H|itching, red, puffy, or blistering, do not use this product and||
9198|027|H|contact your doctor. If there is just mild redness, then||
9198|028|H|treatment with this product may begin.||
9198|029|H|   Apply this medication to the affected areas of skin, usually||
9198|030|H|twice daily or as directed by your doctor. This medication is for||
9198|031|H|use on the skin only. If it is used incorrectly, unwanted skin||
9198|032|H|lightening may occur. Avoid getting this product in your eyes or||
9198|033|H|on the inside of your nose or mouth. If you do get this||
9198|034|H|medication in those areas, flush with plenty of water.||
9198|035|H|   This medication may make the treated areas of skin more||
9198|036|H|sensitive to the sun. Avoid prolonged sun exposure, tanning||
9198|037|H|booths, and sunlamps. Use a sunscreen and wear protective||
9198|038|H|clothing on the treated areas of skin when outdoors.||
9198|039|H|   Use this medication regularly to get the most benefit from it.||
9198|040|H|To help you remember, use it at the same times each day.||
9198|041|H|   Tell your doctor if your condition lasts or gets worse after 2||
9198|042|H|months.||
9198|043|B|||
9198|044|S|SIDE EFFECTS:  See also How to Use.||
9198|045|S|   Mild burning, stinging, redness, and dryness may occur. If any||
9198|046|S|of these effects last or get worse, tell your doctor or||
9198|047|S|pharmacist promptly.||
9198|048|S|   If your doctor has prescribed this medication, remember that||
9198|049|S|your doctor has judged that the benefit to you is greater than||
9198|050|S|the risk of side effects. Many people using this medication do||
9198|051|S|not have serious side effects.||
9198|052|S|   Stop using hydroquinone and tell your doctor right away if you||
9198|053|S|have any serious side effects, including: blistering, skin||
9198|054|S|cracking, blue-black darkening of the skin.||
9198|055|S|   A very serious allergic reaction to this drug is rare.||
9198|056|S|However, get medical help right away if you notice any symptoms||
9198|057|S|of a serious allergic reaction, including: rash, itching/swelling||
9198|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9198|059|S|breathing.||
9198|060|S|   This is not a complete list of possible side effects. If you||
9198|061|S|notice other effects not listed above, contact your doctor or||
9198|062|S|pharmacist.||
9198|063|S|   In the US -||
9198|064|S|   Call your doctor for medical advice about side effects. You||
9198|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9198|066|S|www.fda.gov/medwatch.||
9198|067|S|   In Canada - Call your doctor for medical advice about side||
9198|068|S|effects. You may report side effects to Health Canada at||
9198|069|S|1-866-234-2345.||
9198|070|B|||
9198|071|P|PRECAUTIONS:  Before using hydroquinone, tell your doctor or||
9198|072|P|pharmacist if you are allergic to it; or if you have any other||
9198|073|P|allergies. This product may contain inactive ingredients (such as||
9198|074|P|sulfites), which can cause allergic reactions or other problems.||
9198|075|P|Talk to your pharmacist for more details.||
9198|076|P|   Before using this medication, tell your doctor or pharmacist||
9198|077|P|your medical history, especially of: asthma, other skin||
9198|078|P|conditions (such as eczema, psoriasis).||
9198|079|P|   Before having surgery, tell your doctor or dentist about all||
9198|080|P|the products you use (including prescription drugs,||
9198|081|P|nonprescription drugs, and herbal products).||
9198|082|P|   During pregnancy, this medication should be used only when||
9198|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
9198|084|P|   It is unknown if this drug passes into breast milk. Consult||
9198|085|P|your doctor before breastfeeding.||
9198|086|B|||
9198|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9198|088|I|medications work or increase your risk for serious side effects.||
9198|089|I|This document does not contain all possible drug interactions.||
9198|090|I|Keep a list of all the products you use (including||
9198|091|I|prescription/nonprescription drugs and herbal products) and share||
9198|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
9198|093|I|the dosage of any medicines without your doctor's approval.||
9198|094|B|||
9198|095|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9198|096|O|has overdosed and has serious symptoms such as passing out or||
9198|097|O|trouble breathing, call 911. Otherwise, call a poison control||
9198|098|O|center right away. US residents can call 1-800-222-1222. Canada||
9198|099|O|residents can call 1-844-764-7669. Symptoms after swallowing may||
9198|100|O|include: shaking (tremors), seizures.||
9198|101|B|||
9198|102|N|NOTES:  Do not share this medication with others.||
9198|103|N|   This medication has been prescribed for your current condition||
9198|104|N|only. Do not use it later for another skin problem unless told to||
9198|105|N|do so by your doctor. A different medication may be necessary in||
9198|106|N|that case.||
9198|107|B|||
9198|108|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9198|109|D|If it is near the time of the next dose, skip the missed dose.||
9198|110|D|Use your next dose at the regular time. Do not double the dose to||
9198|111|D|catch up.||
9198|112|B|||
9198|113|R|STORAGE:  Store at room temperature. Keep all medications away||
9198|114|R|from children and pets.||
9198|115|R|   Do not flush medications down the toilet or pour them into a||
9198|116|R|drain unless instructed to do so. Properly discard this product||
9198|117|R|when it is expired or no longer needed. Consult your pharmacist||
9198|118|R|or local waste disposal company.||
9198|119|B|||
9198|120|A|Information last revised May 2024.||
9198|121|A|Copyright(c) 2025 First Databank, Inc.||
9198|122|B|||
9199|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9199|002|Z|does NOT have all possible information about this product. This||
9199|003|Z|information does not assure that this product is safe, effective,||
9199|004|Z|or appropriate for you. This information is not individual||
9199|005|Z|medical advice and does not substitute for the advice of your||
9199|006|Z|health care professional. Always ask your health care||
9199|007|Z|professional for complete information about this product and your||
9199|008|Z|specific health needs.||
9199|009|B|||
9199|010|T|TRANEXAMIC ACID 500 MILLIGRAM TABLET - ORAL||
9199|011|F|(TRAN-ex-AM-ik AS-id)||
9199|012|B|||
9199|013|C|COMMON BRAND NAME(S): Cyklokapron||
9199|014|B|||
9199|015|U|USES:  This medication is used short-term in people with a||
9199|016|U|certain type of bleeding disorder (hemophilia) to prevent and||
9199|017|U|reduce bleeding from having a tooth pulled (extraction). It is||
9199|018|U|also used in people with other high-risk bleeding conditions to||
9199|019|U|control bleeding at such times as after surgery or an injury,||
9199|020|U|during heavy nosebleeds, or during heavy menstrual bleeding.||
9199|021|U|   Tranexamic acid works by helping the blood clot normally to||
9199|022|U|prevent and stop prolonged bleeding. It belongs to a class of||
9199|023|U|drugs known as anti-fibrinolytics.||
9199|024|B|||
9199|025|H|HOW TO USE:  Take this medication by mouth as directed by your||
9199|026|H|doctor, usually 2 to 4 times daily.||
9199|027|H|   The dosage and length of treatment is based on your medical||
9199|028|H|condition and response to treatment. The dosage is also based on||
9199|029|H|your weight. Do not increase your dose, take it more often, or||
9199|030|H|take it for a longer time than prescribed.||
9199|031|H|   Take this medication regularly to get the most benefit from||
9199|032|H|it. To help you remember, take it at the same times each day.||
9199|033|H|   Tell your doctor if your condition lasts or gets worse.||
9199|034|B|||
9199|035|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, or dizziness may||
9199|036|S|occur. If any of these effects last or get worse, tell your||
9199|037|S|doctor or pharmacist promptly.||
9199|038|S|   Remember that this medication has been prescribed because your||
9199|039|S|doctor has judged that the benefit to you is greater than the||
9199|040|S|risk of side effects. Many people using this medication do not||
9199|041|S|have serious side effects.||
9199|042|S|   Tell your doctor right away if you have any serious side||
9199|043|S|effects, including: eye/eyelid problems.||
9199|044|S|   This medication may rarely cause serious problems from blood||
9199|045|S|clots. Get medical help right away if you have: shortness of||
9199|046|S|breath/rapid breathing, chest/jaw/left arm pain, unusual||
9199|047|S|sweating, confusion, sudden dizziness/fainting,||
9199|048|S|pain/swelling/warmth in the groin/calf, sudden/severe headaches,||
9199|049|S|trouble speaking, weakness on one side of the body, sudden vision||
9199|050|S|changes.||
9199|051|S|   A very serious allergic reaction to this drug is rare.||
9199|052|S|However, get medical help right away if you notice any symptoms||
9199|053|S|of a serious allergic reaction, including: rash, itching/swelling||
9199|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9199|055|S|breathing.||
9199|056|S|   This is not a complete list of possible side effects. If you||
9199|057|S|notice other effects not listed above, contact your doctor or||
9199|058|S|pharmacist.||
9199|059|S|   In the US -||
9199|060|S|   Call your doctor for medical advice about side effects. You||
9199|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9199|062|S|www.fda.gov/medwatch.||
9199|063|S|   In Canada - Call your doctor for medical advice about side||
9199|064|S|effects. You may report side effects to Health Canada at||
9199|065|S|1-866-234-2345.||
9199|066|B|||
9199|067|P|PRECAUTIONS:  Before taking tranexamic acid, tell your doctor or||
9199|068|P|pharmacist if you are allergic to it; or if you have any other||
9199|069|P|allergies. This product may contain inactive ingredients, which||
9199|070|P|can cause allergic reactions or other problems. Talk to your||
9199|071|P|pharmacist for more details.||
9199|072|P|   Before using this medication, tell your doctor or pharmacist||
9199|073|P|your medical history, especially of: blood clots (such as in the||
9199|074|P|legs, lungs, brain, eye), bleeding in the brain (subarachnoid||
9199|075|P|hemorrhage), color vision problems, a certain serious blood||
9199|076|P|clotting problem (disseminated intravascular coagulation-DIC),||
9199|077|P|kidney problems (including blood in the urine), irregular||
9199|078|P|menstrual bleeding of unknown cause.||
9199|079|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9199|080|P|can make you more dizzy. Do not drive, use machinery, or do||
9199|081|P|anything that needs alertness until you can do it safely. Limit||
9199|082|P|alcoholic beverages. Talk to your doctor if you are using||
9199|083|P|marijuana (cannabis).||
9199|084|P|   Before having surgery, tell your doctor or dentist about all||
9199|085|P|the products you use (including prescription drugs,||
9199|086|P|nonprescription drugs, and herbal products).||
9199|087|P|   During pregnancy, this medication should be used only when||
9199|088|P|clearly needed. Discuss the risks and benefits with your doctor.||
9199|089|P|   This drug passes into breast milk. Consult your doctor before||
9199|090|P|breastfeeding.||
9199|091|B|||
9199|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9199|093|I|medications work or increase your risk for serious side effects.||
9199|094|I|This document does not contain all possible drug interactions.||
9199|095|I|Keep a list of all the products you use (including||
9199|096|I|prescription/nonprescription drugs and herbal products) and share||
9199|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
9199|098|I|the dosage of any medicines without your doctor's approval.||
9199|099|I|   Some products that may interact with this drug include: "blood||
9199|100|I|thinners" (anticoagulants such as warfarin, heparin), drugs that||
9199|101|I|prevent bleeding (including factor IX complex, anti-inhibitor||
9199|102|I|coagulant concentrates), estrogens, hormonal birth control (such||
9199|103|I|as pills, patch, ring), tibolone.||
9199|104|I|   Check all prescription and nonprescription medicine labels||
9199|105|I|carefully since many medications contain pain relievers/fever||
9199|106|I|reducers (NSAIDs such as aspirin, ibuprofen, naproxen) that may||
9199|107|I|increase your risk of bleeding. However, if your doctor has told||
9199|108|I|you to take low-dose aspirin to prevent heart attack or stroke||
9199|109|I|(usually 81-162 milligrams a day), you should keep taking the||
9199|110|I|aspirin unless your doctor tells you not to. Ask your doctor or||
9199|111|I|pharmacist for more details.||
9199|112|B|||
9199|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9199|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9199|115|O|poison control center right away. US residents can call||
9199|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9199|117|O|Symptoms of overdose may include: severe dizziness, vomiting.||
9199|118|B|||
9199|119|N|NOTES:  Do not share this medication with others.||
9199|120|N|   Lab and/or medical tests (such as eye exams) should be done||
9199|121|N|while you are taking this medication. Keep all medical and lab||
9199|122|N|appointments. Consult your doctor for more details.||
9199|123|B|||
9199|124|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9199|125|D|remember. If it is near the time of the next dose, skip the||
9199|126|D|missed dose. Take your next dose at the regular time. Do not||
9199|127|D|double the dose to catch up.||
9199|128|B|||
9199|129|R|STORAGE:  Store at room temperature away from light and moisture.||
9199|130|R|Do not store in the bathroom. Keep all medications away from||
9199|131|R|children and pets.||
9199|132|R|   Do not flush medications down the toilet or pour them into a||
9199|133|R|drain unless instructed to do so. Properly discard this product||
9199|134|R|when it is expired or no longer needed. Consult your pharmacist||
9199|135|R|or local waste disposal company.||
9199|136|B|||
9199|137|M|MEDICAL ALERT:  Your condition can cause complications in a||
9199|138|M|medical emergency. For information about enrolling in MedicAlert,||
9199|139|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9199|140|B|||
9199|141|A|Information last revised August 2024.||
9199|142|A|Copyright(c) 2025 First Databank, Inc.||
9199|143|B|||
9207|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9207|002|Z|does NOT have all possible information about this product. This||
9207|003|Z|information does not assure that this product is safe, effective,||
9207|004|Z|or appropriate for you. This information is not individual||
9207|005|Z|medical advice and does not substitute for the advice of your||
9207|006|Z|health care professional. Always ask your health care||
9207|007|Z|professional for complete information about this product and your||
9207|008|Z|specific health needs.||
9207|009|B|||
9207|010|T|FLUNARIZINE - ORAL||
9207|011|F|(flew-NAIR-eh-zeen)||
9207|012|B|||
9207|013|U|USES:  This medication is used to prevent migraine headaches.||
9207|014|U|Flunarizine is usually used when other treatments have not||
9207|015|U|worked. It helps to reduce how often you get migraine attacks and||
9207|016|U|may help lessen the severity of an attack. This medication||
9207|017|U|belongs to the class of drugs known as calcium channel blockers.||
9207|018|U|   Flunarizine is not effective in treating a sudden migraine||
9207|019|U|attack. Consult your doctor about other medications you should||
9207|020|U|take to treat a sudden migraine attack.||
9207|021|B|||
9207|022|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9207|023|H|from your pharmacist before you start using flunarizine and each||
9207|024|H|time you get a refill. If you have any questions, ask your doctor||
9207|025|H|or pharmacist.||
9207|026|H|   Take this medication by mouth as directed by your doctor,||
9207|027|H|usually once daily in the evening before bedtime. Do not increase||
9207|028|H|your dose, take it more often, or take it for longer than||
9207|029|H|prescribed.||
9207|030|H|   Take this medication regularly to get the most benefit from||
9207|031|H|it. To help you remember, take it at the same time each day.||
9207|032|H|   It may take up to 6 to 8 weeks of continued treatment before||
9207|033|H|the full benefit of this medication takes effect. Tell your||
9207|034|H|doctor if your condition lasts or gets worse.||
9207|035|B|||
9207|036|S|SIDE EFFECTS:  Drowsiness or tiredness may occur as your body||
9207|037|S|adjusts to the medication. Increase in appetite, weight gain,||
9207|038|S|nausea, heartburn, dry mouth, or anxiety may also occur. Although||
9207|039|S|uncommon, unusual breast milk production may also occur. If any||
9207|040|S|of these effects last or get worse, tell your doctor or||
9207|041|S|pharmacist promptly.||
9207|042|S|   Remember that this medication has been prescribed because your||
9207|043|S|doctor has judged that the benefit to you is greater than the||
9207|044|S|risk of side effects. Many people using this medication do not||
9207|045|S|have serious side effects.||
9207|046|S|   Tell your doctor right away if you have any serious side||
9207|047|S|effects, including: depression, increasing tiredness, movement||
9207|048|S|problems (such as slowed movement, stiffness, restlessness,||
9207|049|S|shaking, unusual/uncontrolled movements especially of the||
9207|050|S|face/arms/legs).||
9207|051|S|   A very serious allergic reaction to this drug is rare.||
9207|052|S|However, get medical help right away if you notice any symptoms||
9207|053|S|of a serious allergic reaction, including: rash, itching/swelling||
9207|054|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9207|055|S|breathing.||
9207|056|S|   This is not a complete list of possible side effects. If you||
9207|057|S|notice other effects not listed above, contact your doctor or||
9207|058|S|pharmacist.||
9207|059|S|   In the US -||
9207|060|S|   Call your doctor for medical advice about side effects. You||
9207|061|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9207|062|S|www.fda.gov/medwatch.||
9207|063|S|   In Canada - Call your doctor for medical advice about side||
9207|064|S|effects. You may report side effects to Health Canada at||
9207|065|S|1-866-234-2345.||
9207|066|B|||
9207|067|P|PRECAUTIONS:  Before taking flunarizine, tell your doctor or||
9207|068|P|pharmacist if you are allergic to it; or if you have any other||
9207|069|P|allergies. This product may contain inactive ingredients, which||
9207|070|P|can cause allergic reactions or other problems. Talk to your||
9207|071|P|pharmacist for more details.||
9207|072|P|   Before using this medication, tell your doctor or pharmacist||
9207|073|P|your medical history, especially of: depression, Parkinson's||
9207|074|P|disease, a certain type of movement disorder (extrapyramidal||
9207|075|P|syndrome), liver disease.||
9207|076|P|   This drug may make you drowsy. Alcohol or marijuana (cannabis)||
9207|077|P|can make you more drowsy. Do not drive, use machinery, or do||
9207|078|P|anything that needs alertness until you can do it safely. Limit||
9207|079|P|alcoholic beverages. Talk to your doctor if you are using||
9207|080|P|marijuana (cannabis).||
9207|081|P|   Before having surgery, tell your doctor or dentist about all||
9207|082|P|the products you use (including prescription drugs,||
9207|083|P|nonprescription drugs, and herbal products).||
9207|084|P|   Older adults may be more sensitive to the side effects of this||
9207|085|P|drug, especially movement problems and shaking.||
9207|086|P|   During pregnancy, this medication should be used only when||
9207|087|P|clearly needed. Discuss the risks and benefits with your doctor.||
9207|088|P|   It is unknown if this drug passes into breast milk.||
9207|089|P|Breastfeeding is not recommended while using this drug. Consult||
9207|090|P|your doctor before breastfeeding.||
9207|091|B|||
9207|092|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9207|093|I|medications work or increase your risk for serious side effects.||
9207|094|I|This document does not contain all possible drug interactions.||
9207|095|I|Keep a list of all the products you use (including||
9207|096|I|prescription/nonprescription drugs and herbal products) and share||
9207|097|I|it with your doctor and pharmacist. Do not start, stop, or change||
9207|098|I|the dosage of any medicines without your doctor's approval.||
9207|099|I|   Some products that may interact with this drug are:||
9207|100|I|anti-seizure medications (such as carbamazepine, phenytoin,||
9207|101|I|phenobarbital).||
9207|102|I|   Tell your doctor or pharmacist if you are taking other||
9207|103|I|products that cause drowsiness such as opioid pain or cough||
9207|104|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9207|105|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9207|106|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9207|107|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
9207|108|I|diphenhydramine).||
9207|109|I|   Check the labels on all your medicines (such as allergy or||
9207|110|I|cough-and-cold products) because they may contain ingredients||
9207|111|I|that cause drowsiness. Ask your pharmacist about using those||
9207|112|I|products safely.||
9207|113|B|||
9207|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9207|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9207|116|O|poison control center right away. US residents can call||
9207|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9207|118|O|Symptoms of overdose may include: severe drowsiness, weakness,||
9207|119|O|agitation, confusion, fast heartbeat.||
9207|120|B|||
9207|121|N|NOTES:  Do not share this medication with others.||
9207|122|B|||
9207|123|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9207|124|D|remember. If it is near the time of the next dose, skip the||
9207|125|D|missed dose. Take your next dose at the regular time. Do not||
9207|126|D|double the dose to catch up.||
9207|127|B|||
9207|128|R|STORAGE:  Store at room temperature away from light and moisture.||
9207|129|R|Do not store in the bathroom. Keep all medications away from||
9207|130|R|children and pets.||
9207|131|R|   Do not flush medications down the toilet or pour them into a||
9207|132|R|drain unless instructed to do so. Properly discard this product||
9207|133|R|when it is expired or no longer needed. Consult your pharmacist||
9207|134|R|or local waste disposal company.||
9207|135|B|||
9207|136|A|Information last revised May 2024.||
9207|137|A|Copyright(c) 2025 First Databank, Inc.||
9207|138|B|||
9209|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9209|002|Z|does NOT have all possible information about this product. This||
9209|003|Z|information does not assure that this product is safe, effective,||
9209|004|Z|or appropriate for you. This information is not individual||
9209|005|Z|medical advice and does not substitute for the advice of your||
9209|006|Z|health care professional. Always ask your health care||
9209|007|Z|professional for complete information about this product and your||
9209|008|Z|specific health needs.||
9209|009|B|||
9209|010|T|DORNASE ALFA SOLUTION - INHALATION||
9209|011|F|(DOOR-naze AL-fa)||
9209|012|B|||
9209|013|C|COMMON BRAND NAME(S): Pulmozyme||
9209|014|B|||
9209|015|U|USES:  This medication is used to improve breathing and reduce||
9209|016|U|the risk of lung infections in people with cystic fibrosis. It is||
9209|017|U|used along with other treatments for this disease (such as chest||
9209|018|U|physical therapy, medications, nutritional supplements). Dornase||
9209|019|U|alfa is the same as a substance (DNase I enzyme) that is||
9209|020|U|naturally produced by the body. It works in the airways by||
9209|021|U|decreasing stickiness/thickness of mucus so that it can be||
9209|022|U|cleared from the lungs more easily.||
9209|023|B|||
9209|024|H|HOW TO USE:  Read the Instructions for Use if available from your||
9209|025|H|pharmacist before you start using dornase alfa and each time you||
9209|026|H|get a refill. If you have any questions, ask your doctor or||
9209|027|H|pharmacist.||
9209|028|H|   This medication is inhaled into the lungs using special||
9209|029|H|breathing equipment as directed by your doctor, usually once or||
9209|030|H|twice daily. A health care professional will show you the proper||
9209|031|H|way to prepare the medication and use the equipment. If you are||
9209|032|H|unclear about any of the instructions, ask your health care||
9209|033|H|professional.||
9209|034|H|   The dosage is based on your medical condition and response to||
9209|035|H|treatment. Do not increase your dose or take this medication more||
9209|036|H|often than prescribed. Your condition will not improve faster and||
9209|037|H|the risk for side effects may be increased.||
9209|038|H|   Use this medication regularly to get the most benefit from it.||
9209|039|H|To help you remember, use it at the same time(s) each day.||
9209|040|B|||
9209|041|S|SIDE EFFECTS:  Sore/dry throat and hoarseness may occur. Eye||
9209|042|S|redness/irritation may also rarely occur. If any of these effects||
9209|043|S|last or get worse, tell your doctor or pharmacist promptly.||
9209|044|S|   Remember that this medication has been prescribed because your||
9209|045|S|doctor has judged that the benefit to you is greater than the||
9209|046|S|risk of side effects. Many people using this medication do not||
9209|047|S|have serious side effects.||
9209|048|S|   Tell your doctor right away if you have any serious side||
9209|049|S|effects, including: chest pain.||
9209|050|S|   A very serious allergic reaction to this drug is rare.||
9209|051|S|However, get medical help right away if you notice any symptoms||
9209|052|S|of a serious allergic reaction, including: rash, itching/swelling||
9209|053|S|(especially of the face/tongue/throat), severe dizziness, unusual||
9209|054|S|trouble breathing.||
9209|055|S|   This is not a complete list of possible side effects. If you||
9209|056|S|notice other effects not listed above, contact your doctor or||
9209|057|S|pharmacist.||
9209|058|S|   In the US -||
9209|059|S|   Call your doctor for medical advice about side effects. You||
9209|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9209|061|S|www.fda.gov/medwatch.||
9209|062|S|   In Canada - Call your doctor for medical advice about side||
9209|063|S|effects. You may report side effects to Health Canada at||
9209|064|S|1-866-234-2345.||
9209|065|B|||
9209|066|P|PRECAUTIONS:  Before using dornase alfa, tell your doctor or||
9209|067|P|pharmacist if you are allergic to it; or if you have any other||
9209|068|P|allergies. This product may contain inactive ingredients, which||
9209|069|P|can cause allergic reactions or other problems. Talk to your||
9209|070|P|pharmacist for more details.||
9209|071|P|   Before using this medication, tell your doctor or pharmacist||
9209|072|P|your medical history.||
9209|073|P|   Tell your doctor if you are pregnant before using this||
9209|074|P|medication.||
9209|075|P|   It is unknown if this medication passes into breast milk.||
9209|076|P|Consult your doctor before breastfeeding.||
9209|077|B|||
9209|078|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9209|079|I|medications work or increase your risk for serious side effects.||
9209|080|I|This document does not contain all possible drug interactions.||
9209|081|I|Keep a list of all the products you use (including||
9209|082|I|prescription/nonprescription drugs and herbal products) and share||
9209|083|I|it with your doctor and pharmacist. Do not start, stop, or change||
9209|084|I|the dosage of any medicines without your doctor's approval.||
9209|085|B|||
9209|086|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9209|087|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9209|088|O|poison control center right away. US residents can call||
9209|089|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9209|090|B|||
9209|091|N|NOTES:  Do not share this medication with others.||
9209|092|B|||
9209|093|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9209|094|D|If it is near the time of the next dose, skip the missed dose.||
9209|095|D|Use your next dose at the regular time. Do not double the dose to||
9209|096|D|catch up.||
9209|097|B|||
9209|098|R|STORAGE:  Store in the refrigerator away from light and heat. Do||
9209|099|R|not freeze. Keep all medications away from children and pets.||
9209|100|R|   Do not flush medications down the toilet or pour them into a||
9209|101|R|drain unless instructed to do so. Properly discard this product||
9209|102|R|when it is expired or no longer needed. Consult your pharmacist||
9209|103|R|or local waste disposal company.||
9209|104|B|||
9209|105|A|Information last revised May 2024.||
9209|106|A|Copyright(c) 2025 First Databank, Inc.||
9209|107|B|||
9211|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9211|002|Z|does NOT have all possible information about this product. This||
9211|003|Z|information does not assure that this product is safe, effective,||
9211|004|Z|or appropriate for you. This information is not individual||
9211|005|Z|medical advice and does not substitute for the advice of your||
9211|006|Z|health care professional. Always ask your health care||
9211|007|Z|professional for complete information about this product and your||
9211|008|Z|specific health needs.||
9211|009|B|||
9211|010|T|SARGRAMOSTIM - INJECTION||
9211|011|F|(SAR-gra-MOE-stim)||
9211|012|B|||
9211|013|C|COMMON BRAND NAME(S): Leukine||
9211|014|B|||
9211|015|U|USES:  Sargramostim is a man-made version of a certain natural||
9211|016|U|substance made in your body. It is used to help your body make||
9211|017|U|more white blood cells. White blood cells are important to help||
9211|018|U|you fight off infections. Sargramostim is given to people whose||
9211|019|U|ability to make white blood cells is reduced (for instance, due||
9211|020|U|to chemotherapy or exposure to large amounts of radiation). It is||
9211|021|U|also used in certain treatment procedures (such as bone||
9211|022|U|marrow/stem cell transplant).||
9211|023|B|||
9211|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9211|025|H|from your pharmacist before you start using sargramostim and each||
9211|026|H|time you get a refill. If you have any questions, ask your doctor||
9211|027|H|or pharmacist.||
9211|028|H|   This medication is given by injection under the skin or into a||
9211|029|H|vein as directed by your doctor, usually once a day. The dosage||
9211|030|H|is based on your medical condition, body size, lab tests, and||
9211|031|H|response to treatment.||
9211|032|H|   If you are receiving this medication into a vein, infusion||
9211|033|H|reactions may happen during the infusion of this drug. These||
9211|034|H|reactions usually occur with the first dose of each treatment||
9211|035|H|period. Tell your doctor right away if you have any symptoms of||
9211|036|H|infusion reactions such as flushing, shortness of breath,||
9211|037|H|dizziness, fainting, or fast heartbeat.||
9211|038|H|   If you are injecting this medication under the skin and using||
9211|039|H|it at home, learn all preparation and usage instructions from||
9211|040|H|your health care professional and the product package. Do not||
9211|041|H|shake the medication. Before using, check this product for||
9211|042|H|particles or discoloration. If either is present, do not use the||
9211|043|H|liquid. Before injecting each dose, clean the skin you are going||
9211|044|H|to inject into (the injection site) with rubbing alcohol. Change||
9211|045|H|the injection site each time to lessen injury under the skin. Do||
9211|046|H|not inject into skin that is bruised, tender, red, hard, or that||
9211|047|H|has scars or stretch marks. To lessen bruising, do not rub the||
9211|048|H|injection site after a shot. Learn how to store and discard||
9211|049|H|medical supplies safely.||
9211|050|H|   Use this medication regularly in order to get the most benefit||
9211|051|H|from it. To help you remember, use it at the same time each day.||
9211|052|H|   If you are receiving cancer chemotherapy or radiation||
9211|053|H|treatment, you should not use this medication within 24 hours||
9211|054|H|before or 24 hours after chemotherapy or radiation treatment. Ask||
9211|055|H|your doctor for specific directions about when to use this||
9211|056|H|medication.||
9211|057|B|||
9211|058|S|SIDE EFFECTS:  See also How to Use section.||
9211|059|S|   Aching or pain in the bones and muscles or headache may occur.||
9211|060|S|Taking a non-aspirin pain reliever such as acetaminophen may help||
9211|061|S|relieve pain. Ask your doctor or pharmacist for more details.||
9211|062|S|Redness, swelling, itching, or bruising at the injection site may||
9211|063|S|also occur. If any of these effects last or get worse, tell your||
9211|064|S|doctor or pharmacist promptly.||
9211|065|S|   Remember that this medication has been prescribed because your||
9211|066|S|doctor has judged that the benefit to you is greater than the||
9211|067|S|risk of side effects. Many people using this medication do not||
9211|068|S|have serious side effects.||
9211|069|S|   Tell your doctor right away if you have any serious side||
9211|070|S|effects, including: fast/irregular heartbeat, chest pain, sudden||
9211|071|S|weight gain, swelling ankles/feet/hands, shortness of breath,||
9211|072|S|black/bloody stools, stomach/abdominal pain, vomit that is bloody||
9211|073|S|or looks like coffee grounds, vision problems.||
9211|074|S|   A very serious allergic reaction to this drug is rare.||
9211|075|S|However, get medical help right away if you notice any symptoms||
9211|076|S|of a serious allergic reaction, including: rash, itching/swelling||
9211|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9211|078|S|breathing.||
9211|079|S|   This is not a complete list of possible side effects. If you||
9211|080|S|notice other effects not listed above, contact your doctor or||
9211|081|S|pharmacist.||
9211|082|S|   In the US -||
9211|083|S|   Call your doctor for medical advice about side effects. You||
9211|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9211|085|S|www.fda.gov/medwatch.||
9211|086|S|   In Canada - Call your doctor for medical advice about side||
9211|087|S|effects. You may report side effects to Health Canada at||
9211|088|S|1-866-234-2345.||
9211|089|B|||
9211|090|P|PRECAUTIONS:  Before using sargramostim, tell your doctor or||
9211|091|P|pharmacist if you are allergic to it; or to yeast; or if you have||
9211|092|P|any other allergies. This product may contain inactive||
9211|093|P|ingredients (such as benzyl alcohol), which can cause allergic||
9211|094|P|reactions or other problems. Talk to your pharmacist for more||
9211|095|P|details.||
9211|096|P|   Before using this medication, tell your doctor or pharmacist||
9211|097|P|your medical history, especially of: lung disease, heart problems||
9211|098|P|(such as heart failure, irregular heartbeat), liver disease,||
9211|099|P|kidney disease, swelling (edema).||
9211|100|P|   Before having surgery, tell your doctor or dentist about all||
9211|101|P|the products you use (including prescription drugs,||
9211|102|P|nonprescription drugs, and herbal products).||
9211|103|P|   During pregnancy, this medication should be used only when||
9211|104|P|clearly needed. Discuss the risks and benefits with your doctor.||
9211|105|P|   It is unknown if this drug passes into breast milk. Consult||
9211|106|P|your doctor before breastfeeding.||
9211|107|B|||
9211|108|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9211|109|I|medications work or increase your risk for serious side effects.||
9211|110|I|This document does not contain all possible drug interactions.||
9211|111|I|Keep a list of all the products you use (including||
9211|112|I|prescription/nonprescription drugs and herbal products) and share||
9211|113|I|it with your doctor and pharmacist. Do not start, stop, or change||
9211|114|I|the dosage of any medicines without your doctor's approval.||
9211|115|B|||
9211|116|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9211|117|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9211|118|O|poison control center right away. US residents can call||
9211|119|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9211|120|B|||
9211|121|N|NOTES:  Do not share this medication with others.||
9211|122|N|   Lab and/or medical tests (such as complete blood count,||
9211|123|N|kidney/liver function) should be done while you are using this||
9211|124|N|medication. Keep all medical and lab appointments. Consult your||
9211|125|N|doctor for more details.||
9211|126|B|||
9211|127|D|MISSED DOSE:  It is important to get each dose of this medication||
9211|128|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9211|129|D|right away for a new dosing schedule. Do not double the dose to||
9211|130|D|catch up.||
9211|131|B|||
9211|132|R|STORAGE:  Store in the refrigerator. Do not freeze or shake. Keep||
9211|133|R|the medication in the original package to protect from light.||
9211|134|R|After mixing, use within time period noted in the product||
9211|135|R|instructions or consult your pharmacist. Keep all medications||
9211|136|R|away from children and pets.||
9211|137|R|   Do not flush medications down the toilet or pour them into a||
9211|138|R|drain unless instructed to do so. Properly discard this product||
9211|139|R|when it is expired or no longer needed. Consult your pharmacist||
9211|140|R|or local waste disposal company.||
9211|141|B|||
9211|142|A|Information last revised October 2024.||
9211|143|A|Copyright(c) 2025 First Databank, Inc.||
9211|144|B|||
9213|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9213|002|Z|does NOT have all possible information about this product. This||
9213|003|Z|information does not assure that this product is safe, effective,||
9213|004|Z|or appropriate for you. This information is not individual||
9213|005|Z|medical advice and does not substitute for the advice of your||
9213|006|Z|health care professional. Always ask your health care||
9213|007|Z|professional for complete information about this product and your||
9213|008|Z|specific health needs.||
9213|009|B|||
9213|010|T|EYE LUBRICANT - OPHTHALMIC||
9213|011|B|||
9213|012|U|USES:  This medication is used to relieve dry, irritated eyes.||
9213|013|U|Common causes for dry eyes include wind, sun, heating/air||
9213|014|U|conditioning, computer use/reading, and certain medications.||
9213|015|U|   This product may contain 1 or more of the following||
9213|016|U|ingredients: carboxymethylcellulose, dextran, glycerin,||
9213|017|U|hypromellose, polyethylene glycol 400 (PEG 400), polysorbate,||
9213|018|U|polyvinyl alcohol, povidone, or propylene glycol, among others.||
9213|019|U|   Eye lubricants keep the eye moist, help to protect the eye||
9213|020|U|from injury and infection, and decrease symptoms of dry eyes such||
9213|021|U|as burning, itching, and feeling as if something is in the eye.||
9213|022|B|||
9213|023|H|HOW TO USE:  Follow all directions on the product package. If||
9213|024|H|your doctor has prescribed this medication, use this medication||
9213|025|H|in the affected eye(s) as directed by your doctor. If you have||
9213|026|H|any questions, ask your doctor or pharmacist.||
9213|027|H|   Do not use a solution that has changed color or is cloudy.||
9213|028|H|Certain brands (containing glycerin with polysorbates, among||
9213|029|H|other ingredients) may have a milky appearance. This is okay as||
9213|030|H|long as the solution does not change color. Some eye drops need||
9213|031|H|to be shaken before use. Check the label to see if you should||
9213|032|H|shake your product before using.||
9213|033|H|   To apply eye ointment/drops/gels: Wash hands first. To avoid||
9213|034|H|contamination, do not touch the dropper tip or the tube tip of||
9213|035|H|the ointment or let it touch your eye or any other surface.||
9213|036|H|Always replace the cap tightly after each use. Tilt your head||
9213|037|H|back, look up, and pull down the lower eyelid to make a pouch.||
9213|038|H|For drops/gels, place the dropper directly over the eye and||
9213|039|H|squeeze out 1 or 2 drops as needed. Look down and gently close||
9213|040|H|your eye for 1 or 2 minutes. Place one finger at the corner of||
9213|041|H|the eye near the nose and apply gentle pressure. This will||
9213|042|H|prevent the medication from draining away from the eye. For an||
9213|043|H|ointment, hold the tube directly over the eye and gently squeeze||
9213|044|H|a small strip (one-fourth of an inch or roughly 6 millimeters) of||
9213|045|H|ointment into the pouch. Release the eyelid, close the eye, and||
9213|046|H|slowly roll your eye in all directions to spread the medication.||
9213|047|H|Blot away any extra ointment from around the eye with a clean||
9213|048|H|tissue.||
9213|049|H|   If you are also using another kind of eye medication (such as||
9213|050|H|drops or ointments), wait at least 5 minutes before applying||
9213|051|H|other medications. Use eye drops before eye ointments to allow||
9213|052|H|the eye drops to enter the eye.||
9213|053|H|   Wait several minutes for your vision to clear before driving||
9213|054|H|or operating machinery.||
9213|055|H|   If you wear contact lenses, remove them before using most||
9213|056|H|kinds of eye lubricants. Ask your doctor or pharmacist when you||
9213|057|H|may replace your contact lenses. There are a few types of eye||
9213|058|H|lubricants (some that contain polysorbates) that can be used||
9213|059|H|while wearing contact lenses. Check the package to see if you can||
9213|060|H|wear your contact lenses while using your product.||
9213|061|H|   Tell your doctor if your condition lasts or gets worse after 3||
9213|062|H|days.||
9213|063|B|||
9213|064|S|SIDE EFFECTS:  Vision may be temporarily blurred when this||
9213|065|S|product is first used. Also, minor burning/stinging/irritation||
9213|066|S|may temporarily occur. If any of these effects last or get worse,||
9213|067|S|tell your doctor or pharmacist promptly.||
9213|068|S|   If your doctor has directed you to use this medication,||
9213|069|S|remember that your doctor has judged that the benefit to you is||
9213|070|S|greater than the risk of side effects. Many people using this||
9213|071|S|medication do not have serious side effects.||
9213|072|S|   Tell your doctor right away if you have any serious side||
9213|073|S|effects, including: eye pain, change in vision, continued eye||
9213|074|S|redness/irritation.||
9213|075|S|   A very serious allergic reaction to this drug is rare.||
9213|076|S|However, get medical help right away if you notice any symptoms||
9213|077|S|of a serious allergic reaction, including: rash, itching/swelling||
9213|078|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9213|079|S|breathing.||
9213|080|S|   This is not a complete list of possible side effects. If you||
9213|081|S|notice other effects not listed above, contact your doctor or||
9213|082|S|pharmacist.||
9213|083|S|   In the US -||
9213|084|S|   Call your doctor for medical advice about side effects. You||
9213|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9213|086|S|www.fda.gov/medwatch.||
9213|087|S|   In Canada - Call your doctor for medical advice about side||
9213|088|S|effects. You may report side effects to Health Canada at||
9213|089|S|1-866-234-2345.||
9213|090|B|||
9213|091|P|PRECAUTIONS:  Before using this product, tell your doctor or||
9213|092|P|pharmacist if you are allergic to it; or if you have any other||
9213|093|P|allergies. This product may contain inactive ingredients, which||
9213|094|P|can cause allergic reactions or other problems. Talk to your||
9213|095|P|pharmacist for more details.||
9213|096|P|   If you have any health problems, consult your doctor or||
9213|097|P|pharmacist before using this product.||
9213|098|P|   After you apply this product, your vision may become||
9213|099|P|temporarily blurred. Do not drive, use machinery, or do anything||
9213|100|P|that needs clear vision until you can do it safely.||
9213|101|B|||
9213|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9213|103|I|medications work or increase your risk for serious side effects.||
9213|104|I|This document does not contain all possible drug interactions.||
9213|105|I|Keep a list of all the products you use (including||
9213|106|I|prescription/nonprescription drugs and herbal products) and share||
9213|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
9213|108|I|the dosage of any medicines without your doctor's approval.||
9213|109|B|||
9213|110|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9213|111|O|has overdosed and has serious symptoms such as passing out or||
9213|112|O|trouble breathing, call 911. Otherwise, call a poison control||
9213|113|O|center right away. US residents can call 1-800-222-1222. Canada||
9213|114|O|residents can call 1-844-764-7669.||
9213|115|B|||
9213|116|N|NOTES:  Some products contain preservatives that may damage||
9213|117|N|contact lenses or cause irritation in persons with allergies. For||
9213|118|N|more information, check your product package or talk with your||
9213|119|N|health care professional.||
9213|120|B|||
9213|121|D|MISSED DOSE:  This medication is usually used only as needed.||
9213|122|B|||
9213|123|R|STORAGE:  Refer to storage information printed on the package. If||
9213|124|R|you have any questions about storage, ask your pharmacist. Keep||
9213|125|R|all medications away from children and pets.||
9213|126|R|   Do not flush medications down the toilet or pour them into a||
9213|127|R|drain unless instructed to do so. Properly discard this product||
9213|128|R|when it is expired or no longer needed. Consult your pharmacist||
9213|129|R|or local waste disposal company.||
9213|130|B|||
9213|131|A|Information last revised September 2024.||
9213|132|A|Copyright(c) 2025 First Databank, Inc.||
9213|133|B|||
9214|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9214|002|Z|does NOT have all possible information about this product. This||
9214|003|Z|information does not assure that this product is safe, effective,||
9214|004|Z|or appropriate for you. This information is not individual||
9214|005|Z|medical advice and does not substitute for the advice of your||
9214|006|Z|health care professional. Always ask your health care||
9214|007|Z|professional for complete information about this product and your||
9214|008|Z|specific health needs.||
9214|009|B|||
9214|010|T|DECONGESTANT SPRAY - NASAL||
9214|011|B|||
9214|012|U|USES:  This medication is used for temporary relief of congestion||
9214|013|U|in the nose caused by various conditions including the common||
9214|014|U|cold, sinusitis, hay fever, and allergies. It works by narrowing||
9214|015|U|the blood vessels in the nose area, reducing swelling and||
9214|016|U|congestion.||
9214|017|B|||
9214|018|V|OTHER USES:  This section contains uses of this drug that are not||
9214|019|V|listed in the approved professional labeling for the drug but||
9214|020|V|that may be prescribed by your health care professional. Use this||
9214|021|V|drug for a condition that is listed in this section only if it||
9214|022|V|has been so prescribed by your health care professional.||
9214|023|V|   This drug may also be used to relieve "plugged ears" and to||
9214|024|V|reduce swelling in the nose before certain surgery or procedures.||
9214|025|B|||
9214|026|H|HOW TO USE:  Use this medication in the nose as directed. Follow||
9214|027|H|all directions on the product package, or use as directed by your||
9214|028|H|doctor. If you have any questions, ask your doctor or pharmacist.||
9214|029|H|   Gently blow your nose before using this drug. Use your finger||
9214|030|H|to close the nostril on the side not receiving the medication.||
9214|031|H|While keeping your head upright, place the spray tip into the||
9214|032|H|open nostril. Spray the medication into the open nostril as you||
9214|033|H|breathe in through your nose. Sniff hard a few times to be sure||
9214|034|H|the medication reaches deep into the nose. Repeat these steps for||
9214|035|H|the other nostril if needed.||
9214|036|H|   Avoid spraying the medication into your eyes or onto the||
9214|037|H|middle of the inside of your nose (nasal septum).||
9214|038|H|   Rinse the spray tip with hot water or wipe with a clean tissue||
9214|039|H|after each use. Make sure that water does not get inside the||
9214|040|H|container. Replace cap after each use.||
9214|041|H|   This medication provides only temporary relief. Do not use||
9214|042|H|more often, use more sprays, or use longer than directed because||
9214|043|H|doing so may increase the risk of side effects. Also, do not use||
9214|044|H|this medication for more than 3 days or it may cause a condition||
9214|045|H|called rebound congestion. Symptoms of rebound congestion include||
9214|046|H|long-term redness and swelling inside the nose and increased||
9214|047|H|runny nose. If this occurs, stop using this medication and||
9214|048|H|consult your doctor or pharmacist.||
9214|049|H|   Tell your doctor if your condition gets worse or lasts after 3||
9214|050|H|days.||
9214|051|B|||
9214|052|S|SIDE EFFECTS:  Temporary burning, stinging, dryness in the nose,||
9214|053|S|runny nose, and sneezing may occur. If any of these effects last||
9214|054|S|or get worse, tell your doctor or pharmacist promptly.||
9214|055|S|   If your doctor has prescribed this medication, remember that||
9214|056|S|your doctor has judged that the benefit to you is greater than||
9214|057|S|the risk of side effects. Many people using this medication do||
9214|058|S|not have serious side effects.||
9214|059|S|   This medication may raise your blood pressure. Check your||
9214|060|S|blood pressure regularly and tell your doctor if the results are||
9214|061|S|high.||
9214|062|S|   Tell your doctor right away if you have any serious side||
9214|063|S|effects, including: slow/fast/pounding heartbeat, dizziness,||
9214|064|S|nausea, headache, mental/mood changes, trouble sleeping, shaking||
9214|065|S|(tremors), unusual sweating, unusual weakness.||
9214|066|S|   A very serious allergic reaction to this drug is rare.||
9214|067|S|However, get medical help right away if you notice any symptoms||
9214|068|S|of a serious allergic reaction, including: rash, itching/swelling||
9214|069|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9214|070|S|breathing.||
9214|071|S|   This is not a complete list of possible side effects. If you||
9214|072|S|notice other effects not listed above, contact your doctor or||
9214|073|S|pharmacist.||
9214|074|S|   In the US -||
9214|075|S|   Call your doctor for medical advice about side effects. You||
9214|076|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9214|077|S|www.fda.gov/medwatch.||
9214|078|S|   In Canada - Call your doctor for medical advice about side||
9214|079|S|effects. You may report side effects to Health Canada at||
9214|080|S|1-866-234-2345.||
9214|081|B|||
9214|082|P|PRECAUTIONS:  Before using this nasal decongestant, tell your||
9214|083|P|doctor or pharmacist if you are allergic to it; or to other||
9214|084|P|sympathomimetics (such as pseudoephedrine); or if you have any||
9214|085|P|other allergies. This product may contain inactive ingredients,||
9214|086|P|which can cause allergic reactions or other problems. Talk to||
9214|087|P|your pharmacist for more details.||
9214|088|P|   If you have any of the following health problems, consult your||
9214|089|P|doctor or pharmacist before using this product: heart/blood||
9214|090|P|vessel disease, overactive thyroid (hyperthyroidism), diabetes,||
9214|091|P|high blood pressure, difficulty urinating (due to enlarged||
9214|092|P|prostate).||
9214|093|P|   Before having surgery, tell your doctor or dentist about all||
9214|094|P|the products you use (including prescription drugs,||
9214|095|P|nonprescription drugs, and herbal products).||
9214|096|P|   Children may be more sensitive to the side effects of this||
9214|097|P|drug. Check the product package or consult with your doctor or||
9214|098|P|pharmacist about whether this nasal spray can be used by||
9214|099|P|children.||
9214|100|P|   During pregnancy, this medication should be used only when||
9214|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
9214|102|P|   It is unknown if this drug passes into breast milk. Consult||
9214|103|P|your doctor before breastfeeding.||
9214|104|B|||
9214|105|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9214|106|I|medications work or increase your risk for serious side effects.||
9214|107|I|This document does not contain all possible drug interactions.||
9214|108|I|Keep a list of all the products you use (including||
9214|109|I|prescription/nonprescription drugs and herbal products) and share||
9214|110|I|it with your doctor and pharmacist. Do not start, stop, or change||
9214|111|I|the dosage of any medicines without your doctor's approval.||
9214|112|I|   Taking MAO inhibitors with this medication may cause a serious||
9214|113|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9214|114|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9214|115|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9214|116|I|selegiline, tranylcypromine) during treatment with this||
9214|117|I|medication. Most MAO inhibitors should also not be taken for two||
9214|118|I|weeks before treatment with this medication. Ask your doctor when||
9214|119|I|to start or stop taking this medication.||
9214|120|B|||
9214|121|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9214|122|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9214|123|O|poison control center right away. US residents can call||
9214|124|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9214|125|O|Symptoms of overdose may include: drowsiness, slow heartbeat,||
9214|126|O|dizziness, fainting.||
9214|127|B|||
9214|128|N|NOTES:  Do not share this medication with others. Use of this||
9214|129|N|container by more than one person may spread infection.||
9214|130|N|   There are various nasal decongestants available, many without||
9214|131|N|a prescription. Talk with your doctor or pharmacist about which||
9214|132|N|product is best for you.||
9214|133|B|||
9214|134|D|MISSED DOSE:  Not applicable.||
9214|135|B|||
9214|136|R|STORAGE:  Refer to storage information printed on the package.||
9214|137|R|Protect from heat and light. Keep all medications away from||
9214|138|R|children and pets.||
9214|139|R|   Do not flush medications down the toilet or pour them into a||
9214|140|R|drain unless instructed to do so. Properly discard this product||
9214|141|R|when it is expired or no longer needed. Consult your pharmacist||
9214|142|R|or local waste disposal company.||
9214|143|B|||
9214|144|A|Information last revised July 2025.||
9214|145|A|Copyright(c) 2025 First Databank, Inc.||
9214|146|B|||
9215|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9215|002|Z|does NOT have all possible information about this product. This||
9215|003|Z|information does not assure that this product is safe, effective,||
9215|004|Z|or appropriate for you. This information is not individual||
9215|005|Z|medical advice and does not substitute for the advice of your||
9215|006|Z|health care professional. Always ask your health care||
9215|007|Z|professional for complete information about this product and your||
9215|008|Z|specific health needs.||
9215|009|B|||
9215|010|T|SODIUM CHLORIDE OINTMENT - OPHTHALMIC||
9215|011|F|(SO-dee-um KLOR-ide)||
9215|012|B|||
9215|013|C|COMMON BRAND NAME(S): Muro-128, Sochlor||
9215|014|B|||
9215|015|U|USES:  This product is used to reduce swelling of the surface of||
9215|016|U|the eye (cornea) in certain eye conditions. Decreasing swelling||
9215|017|U|of the cornea may lessen eye discomfort or irritation caused by||
9215|018|U|the swelling. This product works by drawing fluid out of the||
9215|019|U|cornea to reduce swelling.||
9215|020|B|||
9215|021|H|HOW TO USE:  Follow all directions on the product package. If||
9215|022|H|your doctor has prescribed this medication, use this medication||
9215|023|H|in the affected eye(s) as directed by your doctor. If you have||
9215|024|H|any questions, ask your doctor or pharmacist.||
9215|025|H|   If you are wearing contact lenses, remove them before using||
9215|026|H|eye ointments. Wait at least 15 minutes before replacing your||
9215|027|H|contact lenses.||
9215|028|H|   To apply eye ointment, wash your hands first. To avoid||
9215|029|H|contamination, do not touch the tube tip or let it touch your eye||
9215|030|H|or any other surface. Rolling the ointment tube in your hands for||
9215|031|H|a minute will make the ointment flow easier. Tilt your head back,||
9215|032|H|look upward, and gently pull down the lower eyelid to make a||
9215|033|H|pouch. Place a 1/4-inch (0.6-centimeter) strip of ointment into||
9215|034|H|the pouch. Gently close the eye and roll the eyeball in all||
9215|035|H|directions to spread the medication. Try not to blink and do not||
9215|036|H|rub the eye.||
9215|037|H|   Repeat these steps for your other eye if so directed. Wipe the||
9215|038|H|tip of the ointment tube with a clean tissue to remove extra||
9215|039|H|medication before recapping it.||
9215|040|H|   If you are using another kind of eye medication (such as drops||
9215|041|H|or ointments), wait at least 5 to 10 minutes before applying||
9215|042|H|other medications. Use eye drops before eye ointments to allow||
9215|043|H|the drops to enter the eye.||
9215|044|H|   Wait several minutes for your vision to clear before driving||
9215|045|H|or operating machinery.||
9215|046|H|   This product is recommended for use under a doctor's||
9215|047|H|direction. If your condition gets worse, if it lasts for more||
9215|048|H|than 3 days, or if you think you may have a serious medical||
9215|049|H|problem, get medical help right away.||
9215|050|B|||
9215|051|S|SIDE EFFECTS:  Eye discomfort, burning, redness, or temporary||
9215|052|S|blurred vision may occur. If any of these effects last or get||
9215|053|S|worse, tell your doctor or pharmacist promptly.||
9215|054|S|   If your doctor has prescribed this medication, remember that||
9215|055|S|your doctor has judged that the benefit to you is greater than||
9215|056|S|the risk of side effects. Many people using this medication do||
9215|057|S|not have serious side effects.||
9215|058|S|   Tell your doctor right away if you have any serious side||
9215|059|S|effects, including: eye pain, vision changes.||
9215|060|S|   A very serious allergic reaction to this drug is rare.||
9215|061|S|However, get medical help right away if you notice any symptoms||
9215|062|S|of a serious allergic reaction, including: rash, itching/swelling||
9215|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9215|064|S|breathing.||
9215|065|S|   This is not a complete list of possible side effects. If you||
9215|066|S|notice other effects not listed above, contact your doctor or||
9215|067|S|pharmacist.||
9215|068|S|   In the US -||
9215|069|S|   Call your doctor for medical advice about side effects. You||
9215|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9215|071|S|www.fda.gov/medwatch.||
9215|072|S|   In Canada - Call your doctor for medical advice about side||
9215|073|S|effects. You may report side effects to Health Canada at||
9215|074|S|1-866-234-2345.||
9215|075|B|||
9215|076|P|PRECAUTIONS:  Before using sodium chloride eye ointment, tell||
9215|077|P|your doctor or pharmacist if you are allergic to it; or if you||
9215|078|P|have any other allergies. This product may contain inactive||
9215|079|P|ingredients, which can cause allergic reactions or other||
9215|080|P|problems. Talk to your pharmacist for more details.||
9215|081|P|   Before using this product, tell your doctor or pharmacist your||
9215|082|P|medical history, especially of: other eye problems.||
9215|083|P|   After you apply this product, your vision may become||
9215|084|P|temporarily blurred. Do not drive, use machinery, or do anything||
9215|085|P|that needs clear vision until you can do it safely.||
9215|086|P|   This product is safe to use during pregnancy.||
9215|087|P|   It is unknown if this drug passes into breast milk. Consult||
9215|088|P|your doctor before breastfeeding.||
9215|089|B|||
9215|090|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9215|091|I|medications work or increase your risk for serious side effects.||
9215|092|I|This document does not contain all possible drug interactions.||
9215|093|I|Keep a list of all the products you use (including||
9215|094|I|prescription/nonprescription drugs and herbal products) and share||
9215|095|I|it with your doctor and pharmacist. Do not start, stop, or change||
9215|096|I|the dosage of any medicines without your doctor's approval.||
9215|097|B|||
9215|098|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9215|099|O|has overdosed and has serious symptoms such as passing out or||
9215|100|O|trouble breathing, call 911. Otherwise, call a poison control||
9215|101|O|center right away. US residents can call 1-800-222-1222. Canada||
9215|102|O|residents can call 1-844-764-7669.||
9215|103|B|||
9215|104|N|NOTES:  If your doctor has prescribed this medication for you, do||
9215|105|N|not share it with others.||
9215|106|N|   Keep all medical and lab appointments.||
9215|107|B|||
9215|108|D|MISSED DOSE:  If you are using this product on a regular schedule||
9215|109|D|and miss a dose, use it as soon as you remember. If it is near||
9215|110|D|the time of the next dose, skip the missed dose. Use your next||
9215|111|D|dose at the regular time. Do not double the dose to catch up.||
9215|112|B|||
9215|113|R|STORAGE:  Refer to storage information printed on the package.||
9215|114|R|Unless otherwise directed, store at room temperature. Do not||
9215|115|R|freeze. If you have any questions about storage, ask your||
9215|116|R|pharmacist. Keep all medications away from children and pets.||
9215|117|R|   Do not flush medications down the toilet or pour them into a||
9215|118|R|drain unless instructed to do so. Properly discard this product||
9215|119|R|when it is expired or no longer needed. Consult your pharmacist||
9215|120|R|or local waste disposal company.||
9215|121|B|||
9215|122|A|Information last revised May 2024.||
9215|123|A|Copyright(c) 2025 First Databank, Inc.||
9215|124|B|||
9218|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9218|002|Z|does NOT have all possible information about this product. This||
9218|003|Z|information does not assure that this product is safe, effective,||
9218|004|Z|or appropriate for you. This information is not individual||
9218|005|Z|medical advice and does not substitute for the advice of your||
9218|006|Z|health care professional. Always ask your health care||
9218|007|Z|professional for complete information about this product and your||
9218|008|Z|specific health needs.||
9218|009|B|||
9218|010|T|DONEPEZIL - ORAL||
9218|011|F|(doh-NEP-eh-zil)||
9218|012|B|||
9218|013|C|COMMON BRAND NAME(S): Aricept||
9218|014|B|||
9218|015|U|USES:  Donepezil is used to treat confusion (dementia) related to||
9218|016|U|Alzheimer's disease. It does not cure Alzheimer's disease, but it||
9218|017|U|may improve memory, awareness, and the ability to function. This||
9218|018|U|medication is an enzyme blocker that works by restoring the||
9218|019|U|balance of natural substances (neurotransmitters) in the brain.||
9218|020|B|||
9218|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9218|022|H|from your pharmacist before you start taking donepezil and each||
9218|023|H|time you get a refill. If you have any questions, ask your doctor||
9218|024|H|or pharmacist.||
9218|025|H|   Take this medication by mouth with or without food as directed||
9218|026|H|by your doctor, usually once daily just before bedtime. If you||
9218|027|H|experience sleep problems (insomnia), talk to your doctor about||
9218|028|H|switching to a morning dose.||
9218|029|H|   If you are taking the 23-milligram strength tablets, swallow||
9218|030|H|them whole. Do not split, crush, or chew these tablets. Doing so||
9218|031|H|can increase the risk of side effects.||
9218|032|H|   Dosage is based on your medical condition and response to||
9218|033|H|treatment. To reduce your risk of side effects (such as nausea||
9218|034|H|and diarrhea), your doctor will start this medication at a low||
9218|035|H|dose and gradually increase your dose over weeks to months.||
9218|036|H|Follow your doctor's instructions carefully. Do not increase your||
9218|037|H|dose or use this drug more often than prescribed.||
9218|038|H|   If you do not take donepezil for 7 or more days in row, talk||
9218|039|H|with your doctor before starting again. You may need to start at||
9218|040|H|a lower dose to decrease the risk of side effects.||
9218|041|H|   Use this medication regularly in order to get the most benefit||
9218|042|H|from it. To help you remember, take it at the same time each day.||
9218|043|H|Do not stop taking it unless your doctor instructs you to do so.||
9218|044|H|It may take a several weeks before you get the full benefit of||
9218|045|H|this drug.||
9218|046|H|   Tell your doctor if your condition gets worse.||
9218|047|B|||
9218|048|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, loss of||
9218|049|S|appetite/weight loss, dizziness, drowsiness, weakness, trouble||
9218|050|S|sleeping, shakiness (tremor), or muscle cramps may occur as your||
9218|051|S|body adjusts to the drug. These effects usually last 1-3 weeks||
9218|052|S|and then lessen. If any of these effects last or get worse, tell||
9218|053|S|your doctor or pharmacist promptly.||
9218|054|S|   Remember that this medication has been prescribed because your||
9218|055|S|doctor has judged that the benefit to you is greater than the||
9218|056|S|risk of side effects. Many people using this medication do not||
9218|057|S|have serious side effects.||
9218|058|S|   Tell your doctor right away if you have any serious side||
9218|059|S|effects, including: trouble urinating, severe stomach/abdominal||
9218|060|S|pain, black stools, vomit that looks like coffee grounds,||
9218|061|S|seizures.||
9218|062|S|   Get medical help right away if you have any very serious side||
9218|063|S|effects, including: slow/fast/irregular heartbeat, severe||
9218|064|S|dizziness, fainting.||
9218|065|S|   A very serious allergic reaction to this drug is rare.||
9218|066|S|However, get medical help right away if you notice any symptoms||
9218|067|S|of a serious allergic reaction, including: rash, itching/swelling||
9218|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9218|069|S|breathing.||
9218|070|S|   This is not a complete list of possible side effects. If you||
9218|071|S|notice other effects not listed above, contact your doctor or||
9218|072|S|pharmacist.||
9218|073|S|   In the US -||
9218|074|S|   Call your doctor for medical advice about side effects. You||
9218|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9218|076|S|www.fda.gov/medwatch.||
9218|077|S|   In Canada - Call your doctor for medical advice about side||
9218|078|S|effects. You may report side effects to Health Canada at||
9218|079|S|1-866-234-2345.||
9218|080|B|||
9218|081|P|PRECAUTIONS:  Before taking donepezil, tell your doctor or||
9218|082|P|pharmacist if you are allergic to it; or if you have any other||
9218|083|P|allergies. This product may contain inactive ingredients, which||
9218|084|P|can cause allergic reactions or other problems. Talk to your||
9218|085|P|pharmacist for more details.||
9218|086|P|   Before using this medication, tell your doctor or pharmacist||
9218|087|P|your medical history, especially of: breathing problems (such as||
9218|088|P|asthma, chronic obstructive pulmonary disease), fainting,||
9218|089|P|seizures, stomach/intestinal disease (such as ulcers, bleeding),||
9218|090|P|trouble urinating (such as enlarged prostate).||
9218|091|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9218|092|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9218|093|P|machinery, or do anything that needs alertness until you can do||
9218|094|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9218|095|P|are using marijuana (cannabis).||
9218|096|P|   Donepezil may cause a condition that affects the heart rhythm||
9218|097|P|(QT prolongation). QT prolongation can rarely cause serious||
9218|098|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
9218|099|P|as severe dizziness, fainting) that need medical attention right||
9218|100|P|away.||
9218|101|P|   The risk of QT prolongation may be increased if you have||
9218|102|P|certain medical conditions or are taking other drugs that may||
9218|103|P|cause QT prolongation. Before using donepezil, tell your doctor||
9218|104|P|or pharmacist of all the drugs you take and if you have any of||
9218|105|P|the following conditions: certain heart problems (heart failure,||
9218|106|P|slow heartbeat, QT prolongation in the EKG), family history of||
9218|107|P|certain heart problems (QT prolongation in the EKG, sudden||
9218|108|P|cardiac death).||
9218|109|P|   Low levels of potassium or magnesium in the blood may also||
9218|110|P|increase your risk of QT prolongation. This risk may increase if||
9218|111|P|you use certain drugs (such as diuretics/"water pills") or if you||
9218|112|P|have conditions such as severe sweating, diarrhea, or vomiting.||
9218|113|P|Talk to your doctor about using donepezil safely.||
9218|114|P|   Before having surgery, tell your doctor or dentist about all||
9218|115|P|the products you use (including prescription drugs,||
9218|116|P|nonprescription drugs, and herbal products).||
9218|117|P|   Older adults may be more sensitive to the side effects of this||
9218|118|P|drug, especially QT prolongation (see above).||
9218|119|P|   During pregnancy, this medication should be used only when||
9218|120|P|clearly needed. Discuss the risks and benefits with your doctor.||
9218|121|P|   It is unknown if this drug passes into breast milk. Consult||
9218|122|P|your doctor before breastfeeding.||
9218|123|B|||
9218|124|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9218|125|I|medications work or increase your risk for serious side effects.||
9218|126|I|This document does not contain all possible drug interactions.||
9218|127|I|Keep a list of all the products you use (including||
9218|128|I|prescription/nonprescription drugs and herbal products) and share||
9218|129|I|it with your doctor and pharmacist. Do not start, stop, or change||
9218|130|I|the dosage of any medicines without your doctor's approval.||
9218|131|I|   Some products that may interact with this drug include:||
9218|132|I|aspirin/non-steroidal anti-inflammatory drugs (NSAIDs, such as||
9218|133|I|ibuprofen, naproxen).||
9218|134|I|   Check all prescription and nonprescription medicine labels||
9218|135|I|carefully since many medications contain pain relievers/fever||
9218|136|I|reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that if||
9218|137|I|taken together with donepezil may increase your risk for||
9218|138|I|stomach/intestinal bleeding. However, if your doctor has told you||
9218|139|I|to take low-dose aspirin to prevent heart attack or stroke||
9218|140|I|(usually 81-162 milligrams a day), you should keep taking the||
9218|141|I|aspirin unless your doctor tells you not to. Ask your doctor or||
9218|142|I|pharmacist for more details.||
9218|143|B|||
9218|144|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9218|145|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9218|146|O|poison control center right away. US residents can call||
9218|147|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9218|148|O|Symptoms of overdose may include nausea/vomiting that is severe||
9218|149|O|or doesn't stop, excessive sweating, very slow heartbeat, slow or||
9218|150|O|shallow breathing, seizures.||
9218|151|B|||
9218|152|N|NOTES:  Do not share this medication with others.||
9218|153|N|   Lab and/or medical tests (such as weight) should be done while||
9218|154|N|you are taking this medication. Keep all medical and lab||
9218|155|N|appointments. Consult your doctor for more details.||
9218|156|B|||
9218|157|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
9218|158|D|next dose at the regular time. Do not double the dose to catch||
9218|159|D|up.||
9218|160|B|||
9218|161|R|STORAGE:  Store at room temperature away from light and moisture.||
9218|162|R|Do not store in the bathroom. Keep all medications away from||
9218|163|R|children and pets.||
9218|164|R|   Do not flush medications down the toilet or pour them into a||
9218|165|R|drain unless instructed to do so. Properly discard this product||
9218|166|R|when it is expired or no longer needed. Consult your pharmacist||
9218|167|R|or local waste disposal company.||
9218|168|B|||
9218|169|A|Information last revised February 2025.||
9218|170|A|Copyright(c) 2025 First Databank, Inc.||
9218|171|B|||
9221|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9221|002|Z|does NOT have all possible information about this product. This||
9221|003|Z|information does not assure that this product is safe, effective,||
9221|004|Z|or appropriate for you. This information is not individual||
9221|005|Z|medical advice and does not substitute for the advice of your||
9221|006|Z|health care professional. Always ask your health care||
9221|007|Z|professional for complete information about this product and your||
9221|008|Z|specific health needs.||
9221|009|B|||
9221|010|T|POTASSIUM ACID PHOSPHATE - ORAL||
9221|011|F|(poh-TASS-ee-um ACID FOSS-fate)||
9221|012|B|||
9221|013|C|COMMON BRAND NAME(S): K-Phos Original||
9221|014|B|||
9221|015|U|USES:  This medication helps control the amount of calcium in the||
9221|016|U|body and urine. It works by making the urine more acidic.||
9221|017|U|   It is used to prevent calcium kidney stones. It is also used||
9221|018|U|to decrease the amount of ammonia in urine, thereby reducing odor||
9221|019|U|and skin irritation caused by high-ammonia urine. This medication||
9221|020|U|is also given to help certain antibiotics for bladder infections||
9221|021|U|(such as methenamine) work better.||
9221|022|B|||
9221|023|V|OTHER USES:  This section contains uses of this drug that are not||
9221|024|V|listed in the approved professional labeling for the drug but||
9221|025|V|that may be prescribed by your health care professional. Use this||
9221|026|V|drug for a condition that is listed in this section only if it||
9221|027|V|has been so prescribed by your health care professional.||
9221|028|V|   This drug may also be used in people who cannot get enough||
9221|029|V|phosphorus from their diets. Phosphorus is a natural body mineral||
9221|030|V|that is very important for building and maintaining bone.||
9221|031|B|||
9221|032|H|HOW TO USE:  Take this medication by mouth as directed by your||
9221|033|H|doctor, usually 4 times a day with meals and at bedtime. Allow||
9221|034|H|the tablet(s) to dissolve in a full glass (8 ounces or 240||
9221|035|H|milliliters) of water for 3 to 5 minutes. Do not use any liquid||
9221|036|H|other than plain water. If any medication remains undissolved,||
9221|037|H|crush the pieces in the water and stir well. After the medication||
9221|038|H|has completely dissolved, stir and drink the mixture.||
9221|039|H|   Take this medication regularly in order to get the most||
9221|040|H|benefit from it. To help you remember, take it at the same times||
9221|041|H|each day.||
9221|042|H|   The dosage is based on your medical condition and response to||
9221|043|H|treatment.||
9221|044|H|   Take this medication 2-3 hours before or after taking any||
9221|045|H|products containing magnesium, aluminum, or calcium. Some||
9221|046|H|examples include quinapril, vitamins/minerals, and antacids.||
9221|047|H|Dairy products (such as milk, yogurt), juice with added calcium,||
9221|048|H|sucralfate, bismuth subsalicylate, iron, and zinc are also||
9221|049|H|included. These products bind with phosphate, preventing its full||
9221|050|H|absorption.||
9221|051|H|   Take this medication as prescribed. Do not increase your dose||
9221|052|H|or take this more often without your doctor's approval.||
9221|053|B|||
9221|054|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, dizziness, or headache||
9221|055|S|may occur. If any of these effects last or get worse, tell your||
9221|056|S|doctor or pharmacist promptly.||
9221|057|S|   Remember that this medication has been prescribed because your||
9221|058|S|doctor has judged that the benefit to you is greater than the||
9221|059|S|risk of side effects. Many people using this medication do not||
9221|060|S|have serious side effects.||
9221|061|S|   When this medication is first started, there is a chance an||
9221|062|S|old kidney stone will be passed.||
9221|063|S|   Tell your doctor right away if you have any serious side||
9221|064|S|effects, including: bone/joint aches, muscle cramps, stomach||
9221|065|S|pain, confusion, fast/irregular heartbeat, unusual weakness,||
9221|066|S|tingling/numbness of the hands/feet, signs of kidney problems||
9221|067|S|(such as change in the amount of urine).||
9221|068|S|   A very serious allergic reaction to this drug is rare.||
9221|069|S|However, get medical help right away if you notice any symptoms||
9221|070|S|of a serious allergic reaction, including: rash, itching/swelling||
9221|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9221|072|S|breathing.||
9221|073|S|   This is not a complete list of possible side effects. If you||
9221|074|S|notice other effects not listed above, contact your doctor or||
9221|075|S|pharmacist.||
9221|076|S|   In the US -||
9221|077|S|   Call your doctor for medical advice about side effects. You||
9221|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9221|079|S|www.fda.gov/medwatch.||
9221|080|S|   In Canada - Call your doctor for medical advice about side||
9221|081|S|effects. You may report side effects to Health Canada at||
9221|082|S|1-866-234-2345.||
9221|083|B|||
9221|084|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9221|085|P|pharmacist if you are allergic to it; or if you have any other||
9221|086|P|allergies. This product may contain inactive ingredients, which||
9221|087|P|can cause allergic reactions or other problems. Talk to your||
9221|088|P|pharmacist for more details.||
9221|089|P|   Before using this medication, tell your doctor or pharmacist||
9221|090|P|your medical history, especially of: high phosphate/potassium||
9221|091|P|levels, adrenal gland problems (such as Addison's disease), bone||
9221|092|P|problems (such as osteomalacia, rickets), heart disease (such as||
9221|093|P|heart failure, irregular heartbeat), high blood pressure, a||
9221|094|P|certain hormone problem (hypoparathyroidism), kidney disease||
9221|095|P|(including kidney stones), liver disease, certain muscle problem||
9221|096|P|(myotonia congenita), pancreatitis, dehydration, severe||
9221|097|P|burns/wounds.||
9221|098|P|   Before having surgery, tell your doctor or dentist about all||
9221|099|P|the products you use (including prescription drugs,||
9221|100|P|nonprescription drugs, and herbal products).||
9221|101|P|   During pregnancy, this medication should be used only when||
9221|102|P|clearly needed. Discuss the risks and benefits with your doctor.||
9221|103|P|   It is unknown if this drug passes into breast milk. Consult||
9221|104|P|your doctor before breastfeeding.||
9221|105|B|||
9221|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9221|107|I|medications work or increase your risk for serious side effects.||
9221|108|I|This document does not contain all possible drug interactions.||
9221|109|I|Keep a list of all the products you use (including||
9221|110|I|prescription/nonprescription drugs and herbal products) and share||
9221|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
9221|112|I|the dosage of any medicines without your doctor's approval.||
9221|113|I|   Some products that may interact with this drug include:||
9221|114|I|aspirin, burosumab, digoxin, eplerenone, certain high blood||
9221|115|I|pressure drugs (including ACE inhibitors such as lisinopril, ARBs||
9221|116|I|such as valsartan), potassium supplements/salt substitutes,||
9221|117|I|vitamin products (such as vitamin D, calcium), certain "water||
9221|118|I|pills" (including potassium-sparing diuretics such as||
9221|119|I|amiloride/spironolactone/triamterene).||
9221|120|I|   If your doctor has told you to take low-dose aspirin to||
9221|121|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
9221|122|I|you should keep taking the aspirin unless your doctor tells you||
9221|123|I|not to. Ask your doctor or pharmacist for more details.||
9221|124|B|||
9221|125|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9221|126|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9221|127|O|poison control center right away. US residents can call||
9221|128|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9221|129|O|Symptoms of overdose may include: severe diarrhea, muscle spasms.||
9221|130|B|||
9221|131|N|NOTES:  Do not share this medication with others.||
9221|132|N|   Lab and/or medical tests (such as calcium/phosphorus/potassium||
9221|133|N|levels, kidney function) should be done while you are taking this||
9221|134|N|medication. Keep all medical and lab appointments. Consult your||
9221|135|N|doctor for more details.||
9221|136|B|||
9221|137|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9221|138|D|remember. If it is near the time of the next dose, skip the||
9221|139|D|missed dose. Take your next dose at the regular time. Do not||
9221|140|D|double the dose to catch up.||
9221|141|B|||
9221|142|R|STORAGE:  Store at room temperature away from heat, light, and||
9221|143|R|moisture. Do not store in the bathroom. Keep all medications away||
9221|144|R|from children and pets.||
9221|145|R|   Do not flush medications down the toilet or pour them into a||
9221|146|R|drain unless instructed to do so. Properly discard this product||
9221|147|R|when it is expired or no longer needed. Consult your pharmacist||
9221|148|R|or local waste disposal company.||
9221|149|B|||
9221|150|A|Information last revised September 2025.||
9221|151|A|Copyright(c) 2025 First Databank, Inc.||
9221|152|B|||
9223|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9223|002|Z|does NOT have all possible information about this product. This||
9223|003|Z|information does not assure that this product is safe, effective,||
9223|004|Z|or appropriate for you. This information is not individual||
9223|005|Z|medical advice and does not substitute for the advice of your||
9223|006|Z|health care professional. Always ask your health care||
9223|007|Z|professional for complete information about this product and your||
9223|008|Z|specific health needs.||
9223|009|B|||
9223|010|T|ERYTHROMYCIN LACTOBIONATE - INTRAVENOUS||
9223|011|F|(eh-rith-row-MY-sin lack-toe-BYE-oh-nate)||
9223|012|B|||
9223|013|C|COMMON BRAND NAME(S): Erythrocin||
9223|014|B|||
9223|015|U|USES:  Erythromycin is used to treat a wide variety of bacterial||
9223|016|U|infections. It may also be used to prevent certain bacterial||
9223|017|U|infections. Erythromycin is known as a macrolide antibiotic. It||
9223|018|U|works by stopping the growth of bacteria.||
9223|019|B|||
9223|020|H|HOW TO USE:  This medication is usually given by injection into a||
9223|021|H|vein as directed by your doctor, usually every 6 hours. It should||
9223|022|H|be injected slowly over 20 to 60 minutes. Erythromycin may also||
9223|023|H|be given continuously.||
9223|024|H|   You should use this injectable medication only until you are||
9223|025|H|able to take an antibiotic by mouth or until your treatment is||
9223|026|H|finished. The dosage and length of treatment are based on your||
9223|027|H|medical condition, weight, and response to treatment.||
9223|028|H|   If you are using this medication at home, learn all||
9223|029|H|preparation and usage instructions from your health care||
9223|030|H|professional. Before using, check this product for particles or||
9223|031|H|discoloration. If either is present, do not use the liquid. Learn||
9223|032|H|how to store and discard medical supplies safely.||
9223|033|H|   For the best effect, use this antibiotic at evenly spaced||
9223|034|H|times. To help you remember, use this medication at the same||
9223|035|H|time(s) every day.||
9223|036|H|   If you are using this medication to treat an infection,||
9223|037|H|continue to use this medication until the full prescribed amount||
9223|038|H|is finished, even if symptoms disappear after a few days.||
9223|039|H|Stopping the medication too early may result in a return of the||
9223|040|H|infection. Tell your doctor if your condition lasts or gets||
9223|041|H|worse.||
9223|042|H|   If you are using this medication to prevent certain bacterial||
9223|043|H|infections, use it exactly as directed by your doctor. Do not||
9223|044|H|stop using the medication without your doctor's approval.||
9223|045|B|||
9223|046|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea/loose stools, stomach||
9223|047|S|pain, or pain/redness at the injection site may occur. If any of||
9223|048|S|these effects last or get worse, tell your doctor or pharmacist||
9223|049|S|promptly.||
9223|050|S|   Remember that this medication has been prescribed because your||
9223|051|S|doctor has judged that the benefit to you is greater than the||
9223|052|S|risk of side effects. Many people using this medication do not||
9223|053|S|have serious side effects.||
9223|054|S|   Tell your doctor right away if you have any serious side||
9223|055|S|effects, including: nausea/vomiting that doesn't stop, hearing||
9223|056|S|changes (such as ringing in the ears, hearing loss), severe||
9223|057|S|abdominal/stomach pain, unusual weakness/tiredness, dark urine,||
9223|058|S|yellowing skin/eyes, muscle weakness.||
9223|059|S|   Get medical help right away if you have any very serious side||
9223|060|S|effects, including: severe dizziness, fainting, fast/irregular||
9223|061|S|heartbeat.||
9223|062|S|   This medication may rarely cause a severe intestinal condition||
9223|063|S|due to a bacteria called C. difficile. This condition may occur||
9223|064|S|during treatment or weeks to months after treatment has stopped.||
9223|065|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9223|066|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9223|067|S|stool.||
9223|068|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9223|069|S|products because they may make symptoms worse.||
9223|070|S|   Use of this medication for prolonged or repeated periods may||
9223|071|S|result in oral thrush or a new vaginal yeast infection. Contact||
9223|072|S|your doctor if you notice white patches/sores in your mouth, a||
9223|073|S|change in vaginal discharge, or other new symptoms.||
9223|074|S|   A very serious allergic reaction to this drug is rare.||
9223|075|S|However, get medical help right away if you notice any symptoms||
9223|076|S|of a serious allergic reaction, including: rash, itching/swelling||
9223|077|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9223|078|S|breathing.||
9223|079|S|   This is not a complete list of possible side effects. If you||
9223|080|S|notice other effects not listed above, contact your doctor or||
9223|081|S|pharmacist.||
9223|082|S|   In the US -||
9223|083|S|   Call your doctor for medical advice about side effects. You||
9223|084|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9223|085|S|www.fda.gov/medwatch.||
9223|086|S|   In Canada - Call your doctor for medical advice about side||
9223|087|S|effects. You may report side effects to Health Canada at||
9223|088|S|1-866-234-2345.||
9223|089|B|||
9223|090|P|PRECAUTIONS:  Before using erythromycin, tell your doctor or||
9223|091|P|pharmacist if you are allergic to it; or to any other||
9223|092|P|macrolide/ketolide antibiotics (such as clarithromycin,||
9223|093|P|azithromycin); or if you have any other allergies. This product||
9223|094|P|may contain inactive ingredients, which can cause allergic||
9223|095|P|reactions or other problems. Talk to your pharmacist for more||
9223|096|P|details.||
9223|097|P|   Before using this medication, tell your doctor or pharmacist||
9223|098|P|your medical history, especially of: kidney disease, liver||
9223|099|P|disease, a certain type of muscle disease (myasthenia gravis).||
9223|100|P|   Erythromycin may cause live bacterial vaccines (such as||
9223|101|P|typhoid vaccine) to not work well. Tell your health care||
9223|102|P|professional that you are using erythromycin before having any||
9223|103|P|immunizations/vaccinations.||
9223|104|P|   Erythromycin may cause a condition that affects the heart||
9223|105|P|rhythm (QT prolongation). QT prolongation can rarely cause||
9223|106|P|serious (rarely fatal) fast/irregular heartbeat and other||
9223|107|P|symptoms (such as severe dizziness, fainting) that need medical||
9223|108|P|attention right away.||
9223|109|P|   The risk of QT prolongation may be increased if you have||
9223|110|P|certain medical conditions or are taking other drugs that may||
9223|111|P|cause QT prolongation. Before using erythromycin, tell your||
9223|112|P|doctor or pharmacist of all the drugs you take and if you have||
9223|113|P|any of the following conditions: certain heart problems (heart||
9223|114|P|failure, slow heartbeat, QT prolongation in the EKG), family||
9223|115|P|history of certain heart problems (QT prolongation in the EKG,||
9223|116|P|sudden cardiac death).||
9223|117|P|   Low levels of potassium or magnesium in the blood may also||
9223|118|P|increase your risk of QT prolongation. This risk may increase if||
9223|119|P|you use certain drugs (such as diuretics/"water pills") or if you||
9223|120|P|have conditions such as severe sweating, diarrhea, or vomiting.||
9223|121|P|Talk to your doctor about using erythromycin safely.||
9223|122|P|   Before having surgery, tell your doctor or dentist about all||
9223|123|P|the products you use (including prescription drugs,||
9223|124|P|nonprescription drugs, and herbal products).||
9223|125|P|   Babies may be at higher risk for a certain serious stomach||
9223|126|P|problem. Contact your child's doctor right away if your child||
9223|127|P|vomits or becomes irritable with feeding.||
9223|128|P|   Older adults may be more sensitive to the side effects of this||
9223|129|P|drug, especially hearing loss and QT prolongation (see above).||
9223|130|P|   During pregnancy, this medication should be used only when||
9223|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
9223|132|P|   This medication passes into breast milk. Consult your doctor||
9223|133|P|before breastfeeding.||
9223|134|B|||
9223|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9223|136|I|medications work or increase your risk for serious side effects.||
9223|137|I|This document does not contain all possible drug interactions.||
9223|138|I|Keep a list of all the products you use (including||
9223|139|I|prescription/nonprescription drugs and herbal products) and share||
9223|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
9223|141|I|the dosage of any medicines without your doctor's approval.||
9223|142|I|   A product that may interact with this drug is: digoxin.||
9223|143|I|   Many drugs besides erythromycin may affect the heart rhythm||
9223|144|I|(QT prolongation), including amiodarone, dofetilide, pimozide,||
9223|145|I|procainamide, propafenone, quinidine, sotalol, among others.||
9223|146|I|   Other medications can affect the removal of erythromycin from||
9223|147|I|your body, which may affect how erythromycin works. Examples||
9223|148|I|include azole antifungals (such as itraconazole, ketoconazole),||
9223|149|I|certain calcium channel blockers (such as diltiazem, verapamil),||
9223|150|I|certain drugs for seizures (such as carbamazepine, phenytoin,||
9223|151|I|valproate), among others.||
9223|152|I|   This medication can slow down the removal of other medications||
9223|153|I|from your body, which may affect how they work. Examples include||
9223|154|I|bromocriptine, certain benzodiazepines (alprazolam, midazolam,||
9223|155|I|triazolam), colchicine, eletriptan, certain drugs to treat||
9223|156|I|erectile dysfunction-ED or pulmonary hypertension (such as||
9223|157|I|sildenafil, tadalafil), ergot alkaloids (such as ergotamine,||
9223|158|I|dihydroergotamine), certain "statin" drugs (such as lovastatin,||
9223|159|I|simvastatin), vinblastine, among others.||
9223|160|I|   This medication may interfere with certain lab tests (such as||
9223|161|I|urine tests), possibly causing false test results. Make sure lab||
9223|162|I|personnel and all your doctors know you use this drug.||
9223|163|B|||
9223|164|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9223|165|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9223|166|O|poison control center right away. US residents can call||
9223|167|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9223|168|B|||
9223|169|N|NOTES:  Lab and/or medical tests may be done while you are using||
9223|170|N|this medication. Keep all medical and lab appointments. Consult||
9223|171|N|your doctor for more details.||
9223|172|B|||
9223|173|D|MISSED DOSE:  It is important to get each dose of this medication||
9223|174|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9223|175|D|right away for a new dosing schedule. Do not double the dose to||
9223|176|D|catch up.||
9223|177|B|||
9223|178|R|STORAGE:  Consult the product instructions and your pharmacist||
9223|179|R|for storage details. Keep all medications away from children and||
9223|180|R|pets.||
9223|181|R|   Do not flush medications down the toilet or pour them into a||
9223|182|R|drain unless instructed to do so. Properly discard this product||
9223|183|R|when it is expired or no longer needed. Consult your pharmacist||
9223|184|R|or local waste disposal company.||
9223|185|B|||
9223|186|A|Information last revised February 2025.||
9223|187|A|Copyright(c) 2025 First Databank, Inc.||
9223|188|B|||
9224|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9224|002|Z|does NOT have all possible information about this product. This||
9224|003|Z|information does not assure that this product is safe, effective,||
9224|004|Z|or appropriate for you. This information is not individual||
9224|005|Z|medical advice and does not substitute for the advice of your||
9224|006|Z|health care professional. Always ask your health care||
9224|007|Z|professional for complete information about this product and your||
9224|008|Z|specific health needs.||
9224|009|B|||
9224|010|T|CHLORPROMAZINE - INJECTION||
9224|011|F|(klor-PROE-ma-zeen)||
9224|012|B|||
9224|013|W|WARNING:  There may be a slightly increased risk of serious,||
9224|014|W|possibly fatal side effects (such as heart failure,||
9224|015|W|fast/irregular heartbeat, pneumonia) when this medication is used||
9224|016|W|by older adults with dementia. This medication is not approved||
9224|017|W|for the treatment of dementia-related behavior problems. Discuss||
9224|018|W|the risks and benefits of this medication, as well as other||
9224|019|W|effective and possibly safer treatments for dementia-related||
9224|020|W|behavior problems, with the doctor.||
9224|021|B|||
9224|022|U|USES:  This medication is used to treat certain mental/mood||
9224|023|U|disorders (such as schizophrenia, psychotic disorders, manic||
9224|024|U|phase of bipolar disorder, severe behavioral problems in||
9224|025|U|children). Chlorpromazine belongs to a class of drugs known as||
9224|026|U|antipsychotics. It works by helping to restore the balance of||
9224|027|U|certain natural substances in the brain.||
9224|028|U|   Chlorpromazine is also used to control nausea/vomiting,||
9224|029|U|relieve prolonged hiccups, relieve restlessness/anxiety before||
9224|030|U|surgery, treat a certain liver problem (porphyria), and help||
9224|031|U|treat tetanus.||
9224|032|B|||
9224|033|H|HOW TO USE:  This medication is usually given as an injection||
9224|034|H|into the muscle of your buttocks by a health care professional.||
9224|035|H|For some uses (such as tetanus, surgery, prolonged hiccups),||
9224|036|H|chlorpromazine may be given by injection into a vein. You should||
9224|037|H|remain lying down for at least 30 minutes after each injection.||
9224|038|H|   The dosage is based on your medical condition, body weight,||
9224|039|H|and response to treatment.||
9224|040|H|   Tell your doctor if your condition lasts or gets worse.||
9224|041|B|||
9224|042|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, dry mouth,||
9224|043|S|blurred vision, tiredness, nausea, constipation, weight gain, or||
9224|044|S|trouble sleeping may occur. If any of these effects last or get||
9224|045|S|worse, tell your doctor or pharmacist promptly.||
9224|046|S|   Dizziness and lightheadedness can increase the risk of||
9224|047|S|falling. Get up slowly when rising from a sitting or lying||
9224|048|S|position.||
9224|049|S|   Tell your doctor right away if any of these side effects||
9224|050|S|occur: muscle spasm/stiffness, shaking (tremor), restlessness,||
9224|051|S|mask-like expression of the face, drooling/trouble swallowing, or||
9224|052|S|shuffling walk. Your doctor may prescribe another medication to||
9224|053|S|decrease these side effects.||
9224|054|S|   Remember that this medication has been prescribed because your||
9224|055|S|doctor has judged that the benefit to you is greater than the||
9224|056|S|risk of side effects. Many people using this medication do not||
9224|057|S|have serious side effects.||
9224|058|S|   Tell your doctor right away if you have any serious side||
9224|059|S|effects, including: skin discoloration, eye/vision changes, signs||
9224|060|S|of liver disease (such as nausea/vomiting that doesn't stop, loss||
9224|061|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
9224|062|S|urine), signs of infection (such as sore throat that doesn't go||
9224|063|S|away, chills), easy bruising/bleeding, mental/mood changes (such||
9224|064|S|as worsening psychosis, unresponsive/catatonic state).||
9224|065|S|   Rarely, this medication may cause face/muscle twitching and||
9224|066|S|uncontrollable movements (tardive dyskinesia). In some cases,||
9224|067|S|this condition may be permanent. Tell your doctor right away if||
9224|068|S|you develop any uncontrollable movements such as lip smacking,||
9224|069|S|mouth puckering, tongue thrusting, chewing, or unusual arm/leg||
9224|070|S|movements.||
9224|071|S|   In rare cases, chlorpromazine may increase your level of a||
9224|072|S|certain chemical made by the body (prolactin). For females, this||
9224|073|S|increase in prolactin may result in unwanted breast milk,||
9224|074|S|missed/stopped periods, or difficulty becoming pregnant. For||
9224|075|S|males, it may result in decreased sexual ability, inability to||
9224|076|S|produce sperm, or enlarged breasts. If you develop any of these||
9224|077|S|symptoms, tell your doctor right away.||
9224|078|S|   Rarely, males may have a painful or prolonged erection lasting||
9224|079|S|4 or more hours. If this occurs, stop using this drug and get||
9224|080|S|medical help right away, or permanent problems could occur.||
9224|081|S|   Get medical help right away if you have any very serious side||
9224|082|S|effects, including: severe dizziness, fainting, slow/shallow||
9224|083|S|breathing.||
9224|084|S|   This medication may rarely cause a very serious condition||
9224|085|S|called neuroleptic malignant syndrome (NMS). Get medical help||
9224|086|S|right away if you have any of the following symptoms: fever,||
9224|087|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
9224|088|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
9224|089|S|signs of kidney problems (such as change in the amount of urine).||
9224|090|S|   A very serious allergic reaction to this drug is rare.||
9224|091|S|However, get medical help right away if you notice any symptoms||
9224|092|S|of a serious allergic reaction, including: rash, itching/swelling||
9224|093|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9224|094|S|breathing.||
9224|095|S|   This is not a complete list of possible side effects. If you||
9224|096|S|notice other effects not listed above, contact your doctor or||
9224|097|S|pharmacist.||
9224|098|S|   In the US -||
9224|099|S|   Call your doctor for medical advice about side effects. You||
9224|100|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9224|101|S|www.fda.gov/medwatch.||
9224|102|S|   In Canada - Call your doctor for medical advice about side||
9224|103|S|effects. You may report side effects to Health Canada at||
9224|104|S|1-866-234-2345.||
9224|105|B|||
9224|106|P|PRECAUTIONS:  See also Warning section.||
9224|107|P|   Before using chlorpromazine, tell your doctor or pharmacist if||
9224|108|P|you are allergic to it; or to other phenothiazine drugs (such as||
9224|109|P|perphenazine, thioridazine); or if you have any other allergies.||
9224|110|P|This product may contain inactive ingredients (such as sodium||
9224|111|P|metabisulfite), which can cause allergic reactions or other||
9224|112|P|problems. Talk to your pharmacist for more details.||
9224|113|P|   Before using this medication, tell your doctor or pharmacist||
9224|114|P|your medical history, especially of: liver problems, kidney||
9224|115|P|problems, heart problems (such as angina, heart attack,||
9224|116|P|fast/irregular heartbeat), low blood pressure, glaucoma,||
9224|117|P|seizures, enlarged prostate, breathing problems (such as severe||
9224|118|P|asthma, emphysema, lung infections), blood or blood clotting||
9224|119|P|problems (such as low white blood cell count, low platelets,||
9224|120|P|anemia, hemophilia), a certain adrenal gland tumor||
9224|121|P|(pheochromocytoma), drug/alcohol/substance use disorder,||
9224|122|P|Parkinson's disease.||
9224|123|P|   Chlorpromazine may cause a condition that affects the heart||
9224|124|P|rhythm (QT prolongation). QT prolongation can rarely cause||
9224|125|P|serious (rarely fatal) fast/irregular heartbeat and other||
9224|126|P|symptoms (such as severe dizziness, fainting) that need medical||
9224|127|P|attention right away.||
9224|128|P|   The risk of QT prolongation may be increased if you have||
9224|129|P|certain medical conditions or are taking other drugs that may||
9224|130|P|cause QT prolongation. Before using chlorpromazine, tell your||
9224|131|P|doctor or pharmacist of all the drugs you take and if you have||
9224|132|P|any of the following conditions: certain heart problems (heart||
9224|133|P|failure, slow heartbeat, QT prolongation in the EKG), family||
9224|134|P|history of certain heart problems (QT prolongation in the EKG,||
9224|135|P|sudden cardiac death).||
9224|136|P|   Low levels of potassium or magnesium in the blood may also||
9224|137|P|increase your risk of QT prolongation. This risk may increase if||
9224|138|P|you use certain drugs (such as diuretics/"water pills") or if you||
9224|139|P|have conditions such as severe sweating, diarrhea, or vomiting.||
9224|140|P|Talk to your doctor about using chlorpromazine safely.||
9224|141|P|   This drug may make you dizzy or drowsy or cause blurred||
9224|142|P|vision. Alcohol or marijuana (cannabis) can make you more dizzy||
9224|143|P|or drowsy. Do not drive, use machinery, or do anything that needs||
9224|144|P|alertness or clear vision until you can do it safely. Avoid||
9224|145|P|alcoholic beverages. Talk to your doctor if you are using||
9224|146|P|marijuana (cannabis).||
9224|147|P|   Before having surgery or imaging procedures (such as certain||
9224|148|P|X-rays, CT scans) requiring the use of contrast dye (such as||
9224|149|P|metrizamide), tell your doctor or dentist that you are using this||
9224|150|P|medication and about all the products you use (including||
9224|151|P|prescription drugs, nonprescription drugs, and herbal products).||
9224|152|P|   This medication may make you more sensitive to the sun. Limit||
9224|153|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9224|154|P|sunscreen and wear protective clothing when outdoors. Tell your||
9224|155|P|doctor right away if you get sunburned or have skin||
9224|156|P|blisters/redness.||
9224|157|P|   This medication may make you sweat less, making you more||
9224|158|P|likely to get heat stroke. Avoid doing things that may cause you||
9224|159|P|to overheat, such as hard work or exercise in hot weather, or||
9224|160|P|using hot tubs. When the weather is hot, drink a lot of fluids||
9224|161|P|and dress lightly. If you overheat, quickly look for a place to||
9224|162|P|cool down and rest. Get medical help right away if you have a||
9224|163|P|fever that does not go away, mental/mood changes, headache, or||
9224|164|P|dizziness.||
9224|165|P|   Children may be more sensitive to the side effects of this||
9224|166|P|drug, especially uncontrolled movements and slow/shallow||
9224|167|P|breathing. They may be at greater risk when they are sick (such||
9224|168|P|as having viral infection, dehydration).||
9224|169|P|   Older adults may be more sensitive to the side effects of this||
9224|170|P|drug, especially dizziness, lightheadedness, drowsiness,||
9224|171|P|uncontrollable movements, constipation, difficulty urinating,||
9224|172|P|blurred vision, and QT prolongation (see above). Drowsiness,||
9224|173|P|dizziness, and lightheadedness can increase the risk of falling.||
9224|174|P|   During pregnancy, this medication should be used only when||
9224|175|P|clearly needed. Avoid use of chlorpromazine near the due date||
9224|176|P|because it may cause low blood pressure in the mother. Also,||
9224|177|P|babies born to mothers who have used this drug during the last 3||
9224|178|P|months of pregnancy may rarely develop symptoms such as muscle||
9224|179|P|stiffness or shakiness, drowsiness, feeding/breathing||
9224|180|P|difficulties, or constant crying. If you notice any of these||
9224|181|P|symptoms in your newborn, especially during their first month,||
9224|182|P|tell the doctor right away.||
9224|183|P|   Since untreated mental/mood problems (such as schizophrenia,||
9224|184|P|psychotic disorders, bipolar disorder) can be a serious||
9224|185|P|condition, do not stop using this medication unless directed by||
9224|186|P|your doctor. If you are planning pregnancy, become pregnant, or||
9224|187|P|think you may be pregnant, discuss with your doctor right away||
9224|188|P|the benefits and risks of using this medication during pregnancy.||
9224|189|P|   This medication passes into breast milk and may have||
9224|190|P|undesirable effects on a nursing infant. Consult your doctor||
9224|191|P|before breastfeeding.||
9224|192|B|||
9224|193|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9224|194|I|medications work or increase your risk for serious side effects.||
9224|195|I|This document does not contain all possible drug interactions.||
9224|196|I|Keep a list of all the products you use (including||
9224|197|I|prescription/nonprescription drugs and herbal products) and share||
9224|198|I|it with your doctor and pharmacist. Do not start, stop, or change||
9224|199|I|the dosage of any medicines without your doctor's approval.||
9224|200|I|   Some products that may interact with this drug are: lithium,||
9224|201|I|tretinoin.||
9224|202|I|   Many drugs besides chlorpromazine may affect the heart rhythm||
9224|203|I|(QT prolongation), such as amiodarone, dofetilide, pimozide,||
9224|204|I|procainamide, quinidine, sotalol, macrolide antibiotics (such as||
9224|205|I|erythromycin), among others.||
9224|206|I|   The risk of serious side effects (such as slow/shallow||
9224|207|I|breathing, severe drowsiness/dizziness) may be increased if this||
9224|208|I|medication is used with other products that may also cause||
9224|209|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
9224|210|I|if you are taking other products such as opioid pain or cough||
9224|211|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9224|212|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9224|213|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9224|214|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
9224|215|I|diphenhydramine).||
9224|216|I|   Check the labels on all your medicines (such as allergy or||
9224|217|I|cough-and-cold products) because they may contain ingredients||
9224|218|I|that cause drowsiness. Ask your pharmacist about using those||
9224|219|I|products safely.||
9224|220|I|   This medication may interfere with certain lab tests (such as||
9224|221|I|certain pregnancy tests, phenylketonuria tests), possibly causing||
9224|222|I|false test results. Make sure lab personnel and all your doctors||
9224|223|I|know you use this drug.||
9224|224|B|||
9224|225|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9224|226|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9224|227|O|poison control center right away. US residents can call||
9224|228|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9224|229|O|Symptoms of overdose may include: severe drowsiness/deep sleep,||
9224|230|O|loss of consciousness, agitation, restlessness, seizures,||
9224|231|O|irregular heartbeat.||
9224|232|B|||
9224|233|N|NOTES:  Lab and/or medical tests (such as liver function,||
9224|234|N|complete blood counts, eye exams) should be done while you are||
9224|235|N|using this medication. Keep all medical and lab appointments.||
9224|236|N|Consult your doctor for more details.||
9224|237|B|||
9224|238|D|MISSED DOSE:  It is important to get each dose of this medication||
9224|239|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9224|240|D|right away for a new dosing schedule. Do not double the dose to||
9224|241|D|catch up.||
9224|242|B|||
9224|243|R|STORAGE:  Not applicable. This medication is given in a hospital||
9224|244|R|or clinic or doctor's office and will not be stored at home.||
9224|245|B|||
9224|246|A|Information last revised May 2025.||
9224|247|A|Copyright(c) 2025 First Databank, Inc.||
9224|248|B|||
9225|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9225|002|Z|does NOT have all possible information about this product. This||
9225|003|Z|information does not assure that this product is safe, effective,||
9225|004|Z|or appropriate for you. This information is not individual||
9225|005|Z|medical advice and does not substitute for the advice of your||
9225|006|Z|health care professional. Always ask your health care||
9225|007|Z|professional for complete information about this product and your||
9225|008|Z|specific health needs.||
9225|009|B|||
9225|010|T|DILTIAZEM EXTENDED-RELEASE TABLET IN CAPSULE - ORAL||
9225|011|F|(dill-TIE-uh-zem)||
9225|012|B|||
9225|013|C|COMMON BRAND NAME(S): Dilacor XR||
9225|014|B|||
9225|015|U|USES:  Diltiazem is used to treat high blood pressure||
9225|016|U|(hypertension) and prevent chest pain (angina). Lowering high||
9225|017|U|blood pressure helps prevent strokes, heart attacks, and kidney||
9225|018|U|problems. When used regularly, diltiazem can decrease the number||
9225|019|U|and severity of episodes of chest pain from angina. It may help||
9225|020|U|increase your ability to exercise.||
9225|021|U|   Diltiazem is called a calcium channel blocker. It works by||
9225|022|U|relaxing blood vessels in the body and heart so blood can flow||
9225|023|U|more easily. Diltiazem also lowers your heart rate. These effects||
9225|024|U|help the heart work less hard and lower blood pressure.||
9225|025|B|||
9225|026|V|OTHER USES:  This section contains uses of this drug that are not||
9225|027|V|listed in the approved professional labeling for the drug but||
9225|028|V|that may be prescribed by your health care professional. Use this||
9225|029|V|drug for a condition that is listed in this section only if it||
9225|030|V|has been so prescribed by your health care professional.||
9225|031|V|   Diltiazem may also be used to control your heart rate if you||
9225|032|V|have a fast/irregular heartbeat (such as atrial fibrillation).||
9225|033|B|||
9225|034|H|HOW TO USE:  Take this medication by mouth without food as||
9225|035|H|directed by your doctor, usually once daily before breakfast.||
9225|036|H|Swallow the capsules whole. Do not crush or chew the capsules.||
9225|037|H|Doing so can release all of the drug at once and may increase||
9225|038|H|your risk of side effects.||
9225|039|H|   Your doctor may gradually increase your dose. Follow your||
9225|040|H|doctor's instructions carefully. The dosage is based on your||
9225|041|H|medical condition, response to treatment, and other medications||
9225|042|H|you may be taking. Be sure to tell your doctor and pharmacist||
9225|043|H|about all the products you use (including prescription drugs,||
9225|044|H|nonprescription drugs, and herbal products).||
9225|045|H|   Use this medication regularly to get the most benefit from it.||
9225|046|H|To help you remember, use it at the same time each day. Keep||
9225|047|H|taking this medication even if you feel well. Most people with||
9225|048|H|high blood pressure do not feel sick. For the treatment of high||
9225|049|H|blood pressure, it may take 2 weeks before you get the full||
9225|050|H|benefit of this drug.||
9225|051|H|   This medication must be taken regularly to prevent angina. It||
9225|052|H|should not be used to treat angina when it occurs. Use other||
9225|053|H|medications (such as nitroglycerin placed under the tongue) to||
9225|054|H|relieve an angina attack as directed by your doctor. Consult your||
9225|055|H|doctor or pharmacist for details.||
9225|056|H|   Tell your doctor if your condition does not get better or if||
9225|057|H|it gets worse (for example, your blood pressure readings remain||
9225|058|H|high or increase, your chest pain worsens).||
9225|059|B|||
9225|060|S|SIDE EFFECTS:  Dizziness, lightheadedness, weakness, nausea,||
9225|061|S|flushing, constipation, and headache may occur. If any of these||
9225|062|S|effects last or get worse, tell your doctor or pharmacist||
9225|063|S|promptly.||
9225|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
9225|065|S|slowly when rising from a sitting or lying position.||
9225|066|S|   Remember that this medication has been prescribed because your||
9225|067|S|doctor has judged that the benefit to you is greater than the||
9225|068|S|risk of side effects. Many people using this medication do not||
9225|069|S|have serious side effects.||
9225|070|S|   Tell your doctor right away if you have any serious side||
9225|071|S|effects, including: nausea/vomiting that doesn't stop, fainting,||
9225|072|S|new or worsening symptoms of heart failure (such as shortness of||
9225|073|S|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
9225|074|S|weight gain), slow/irregular/pounding/fast heartbeat, mental/mood||
9225|075|S|changes (such as depression, agitation), unusual dreams, severe||
9225|076|S|stomach/abdominal pain, severe constipation, dark urine,||
9225|077|S|yellowing eyes/skin.||
9225|078|S|   A very serious allergic reaction to this drug is rare.||
9225|079|S|However, get medical help right away if you notice any symptoms||
9225|080|S|of a serious allergic reaction, including: rash, itching/swelling||
9225|081|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9225|082|S|breathing.||
9225|083|S|   This is not a complete list of possible side effects. If you||
9225|084|S|notice other effects not listed above, contact your doctor or||
9225|085|S|pharmacist.||
9225|086|S|   In the US -||
9225|087|S|   Call your doctor for medical advice about side effects. You||
9225|088|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9225|089|S|www.fda.gov/medwatch.||
9225|090|S|   In Canada - Call your doctor for medical advice about side||
9225|091|S|effects. You may report side effects to Health Canada at||
9225|092|S|1-866-234-2345.||
9225|093|B|||
9225|094|P|PRECAUTIONS:  Before taking diltiazem, tell your doctor or||
9225|095|P|pharmacist if you are allergic to it; or if you have any other||
9225|096|P|allergies. This product may contain inactive ingredients, which||
9225|097|P|can cause allergic reactions or other problems. Talk to your||
9225|098|P|pharmacist for more details.||
9225|099|P|   Before using this medication, tell your doctor or pharmacist||
9225|100|P|your medical history, especially of: certain types of heart||
9225|101|P|rhythm problems (such as sick sinus syndrome/atrioventricular||
9225|102|P|block), liver disease, kidney disease, heart failure, narrowing||
9225|103|P|of any part of the stomach/intestines.||
9225|104|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9225|105|P|can make you more dizzy. Do not drive, use machinery, or do||
9225|106|P|anything that needs alertness until you can do it safely. Limit||
9225|107|P|alcoholic beverages. Talk to your doctor if you are using||
9225|108|P|marijuana (cannabis).||
9225|109|P|   Before having surgery, tell your doctor or dentist about all||
9225|110|P|the products you use (including prescription drugs,||
9225|111|P|nonprescription drugs, and herbal products).||
9225|112|P|   Older adults may be more sensitive to the side effects of this||
9225|113|P|drug, especially dizziness, constipation, or swelling||
9225|114|P|ankles/feet.||
9225|115|P|   During pregnancy, this medication should be used only when||
9225|116|P|clearly needed. Discuss the risks and benefits with your doctor.||
9225|117|P|   This drug passes into breast milk and may have undesirable||
9225|118|P|effects on a nursing infant. Consult your doctor before||
9225|119|P|breastfeeding.||
9225|120|B|||
9225|121|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9225|122|I|medications work or increase your risk for serious side effects.||
9225|123|I|This document does not contain all possible drug interactions.||
9225|124|I|Keep a list of all the products you use (including||
9225|125|I|prescription/nonprescription drugs and herbal products) and share||
9225|126|I|it with your doctor and pharmacist. Do not start, stop, or change||
9225|127|I|the dosage of any medicines without your doctor's approval.||
9225|128|I|   Some products that may interact with this drug include:||
9225|129|I|digoxin, fingolimod, labetalol.||
9225|130|I|   Other medications can affect the removal of diltiazem from||
9225|131|I|your body, which may affect how this medication works. Examples||
9225|132|I|include azole antifungals (such as ketoconazole), cimetidine,||
9225|133|I|macrolide antibiotics (such as erythromycin), rifamycins (such as||
9225|134|I|rifabutin, rifampin), St. John's wort, among others.||
9225|135|I|   This medication can slow down the removal of other medications||
9225|136|I|from your body, which may affect how they work. Examples of||
9225|137|I|affected drugs include aprepitant/fosaprepitant, buspirone,||
9225|138|I|colchicine, elacestrant, flibanserin, ivabradine, lomitapide,||
9225|139|I|certain benzodiazepines (triazolam, midazolam), among others.||
9225|140|I|   Some products have ingredients that could raise your heart||
9225|141|I|rate or blood pressure. Tell your pharmacist what products you||
9225|142|I|are using, and ask how to use them safely (especially||
9225|143|I|cough-and-cold products, diet aids, or NSAIDs such as||
9225|144|I|ibuprofen/naproxen).||
9225|145|B|||
9225|146|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9225|147|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9225|148|O|poison control center right away. US residents can call||
9225|149|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9225|150|B|||
9225|151|N|NOTES:  Do not share this medication with others. Lifestyle||
9225|152|N|changes such as stress reduction programs, exercise, and dietary||
9225|153|N|changes may increase the effectiveness of this medicine. Talk to||
9225|154|N|your doctor or pharmacist about lifestyle changes that might||
9225|155|N|benefit you.||
9225|156|N|   Lab and/or medical tests (such as kidney/liver function,||
9225|157|N|pulse, blood pressure, EKG) may be done while you are taking this||
9225|158|N|medication. Keep all medical and lab appointments. Consult your||
9225|159|N|doctor for more details.||
9225|160|N|   There are different brands and types of this medication||
9225|161|N|available. Many do not have the same effects. Do not change||
9225|162|N|brands or types without consulting your doctor or pharmacist.||
9225|163|N|   Have your blood pressure checked regularly while taking this||
9225|164|N|medication. Learn how to monitor your own blood pressure at home,||
9225|165|N|and share the results with your doctor.||
9225|166|B|||
9225|167|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9225|168|D|remember. If it is near the time of the next dose, skip the||
9225|169|D|missed dose. Take your next dose at the regular time. Do not||
9225|170|D|double the dose to catch up.||
9225|171|B|||
9225|172|R|STORAGE:  Store at room temperature away from light and moisture.||
9225|173|R|Do not store in the bathroom. Keep all medication away from||
9225|174|R|children and pets.||
9225|175|R|   Do not flush medications down the toilet or pour them into a||
9225|176|R|drain unless instructed to do so. Properly discard this product||
9225|177|R|when it is expired or no longer needed. Consult your pharmacist||
9225|178|R|or local waste disposal company.||
9225|179|B|||
9225|180|M|MEDICAL ALERT:  Your condition can cause complications in a||
9225|181|M|medical emergency. For information about enrolling in MedicAlert,||
9225|182|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9225|183|B|||
9225|184|A|Information last revised March 2025.||
9225|185|A|Copyright(c) 2025 First Databank, Inc.||
9225|186|B|||
9227|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9227|002|Z|does NOT have all possible information about this product. This||
9227|003|Z|information does not assure that this product is safe, effective,||
9227|004|Z|or appropriate for you. This information is not individual||
9227|005|Z|medical advice and does not substitute for the advice of your||
9227|006|Z|health care professional. Always ask your health care||
9227|007|Z|professional for complete information about this product and your||
9227|008|Z|specific health needs.||
9227|009|B|||
9227|010|T|CITRIC ACID/POTASSIUM-SODIUM CITRATES - ORAL||
9227|011|F|(SIT-rick AS-id/poh-TASS-ee-um, SO-dee-um SIT-rates)||
9227|012|B|||
9227|013|C|COMMON BRAND NAME(S): Cytra-3, Polycitra||
9227|014|B|||
9227|015|U|USES:  This medication is used to make the urine less acidic.||
9227|016|U|Urine that is less acidic helps the kidneys get rid of uric acid,||
9227|017|U|helping to prevent gout and certain types of kidney stones||
9227|018|U|(urate). This medication can also prevent and treat certain||
9227|019|U|metabolic problems (acidosis) caused by kidney disease.||
9227|020|U|   Citric acid and citrate salts (which contain potassium and||
9227|021|U|sodium) belong to a class of drugs known as urinary alkalinizers.||
9227|022|U|Because some conditions require you to limit your intake of||
9227|023|U|potassium and sodium, your doctor's choice of product may depend||
9227|024|U|on how much potassium and sodium you can take.||
9227|025|B|||
9227|026|H|HOW TO USE:  Take this medication by mouth as directed by your||
9227|027|H|doctor, usually 4 times a day. To help prevent diarrhea, take||
9227|028|H|each dose after a meal. To prevent stomach upset, mix your||
9227|029|H|prescribed dose of medication in a full glass (4 to 8 ounces or||
9227|030|H|120 to 240 milliliters) of cold water or juice just before||
9227|031|H|taking, or take as directed by your doctor. Drink the entire||
9227|032|H|mixture slowly. If you still have stomach upset, mixing your dose||
9227|033|H|in a larger amount of liquid may help unless your doctor directs||
9227|034|H|you otherwise. Ask your doctor or pharmacist for further||
9227|035|H|instructions.||
9227|036|H|   Dosage is based on your medical condition and response to||
9227|037|H|treatment. Carefully measure the dose using a special measuring||
9227|038|H|device/spoon. Do not use a household spoon because you may not||
9227|039|H|get the correct dose.||
9227|040|H|   The liquid form of this medication must be mixed with at least||
9227|041|H|4 ounces (120 milliliters) of water or juice before taking.||
9227|042|H|   Refrigerating the mixture before drinking may improve the||
9227|043|H|taste. Drink more water or juice after taking this medication||
9227|044|H|unless otherwise directed by your doctor.||
9227|045|H|   Take this medication as prescribed. Do not increase your dose||
9227|046|H|or take this more often without your doctor's approval. Use this||
9227|047|H|medication regularly to get the most benefit from it. To help you||
9227|048|H|remember, take it at the same times each day.||
9227|049|H|   While taking this medication, you may need to test the pH||
9227|050|H|(acidity) of your urine using special paper. The pH will help||
9227|051|H|determine the proper dose. Consult your doctor or pharmacist for||
9227|052|H|more information.||
9227|053|B|||
9227|054|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, and stomach pain may||
9227|055|S|occur. Mixing the medication with water or juice, taking it after||
9227|056|S|meals, and drinking more fluids will help prevent these side||
9227|057|S|effects. If any of these effects last or get worse, tell your||
9227|058|S|doctor or pharmacist promptly.||
9227|059|S|   Remember that this medication has been prescribed because your||
9227|060|S|doctor has judged that the benefit to you is greater than the||
9227|061|S|risk of side effects. Many people using this medication do not||
9227|062|S|have serious side effects.||
9227|063|S|   Tell your doctor right away if you have any serious side||
9227|064|S|effects, including: severe stomach/abdominal pain, swelling of||
9227|065|S|the hands/ankles/feet, tingling/numbness of the hands/feet,||
9227|066|S|weakness, fast/slow/irregular heartbeat, mental/mood changes||
9227|067|S|(such as confusion, restlessness), muscle spasms, seizures,||
9227|068|S|bloody/black/tarry stools, vomit that looks like coffee grounds.||
9227|069|S|   A very serious allergic reaction to this drug is rare.||
9227|070|S|However, get medical help right away if you notice any symptoms||
9227|071|S|of a serious allergic reaction, including: rash, itching/swelling||
9227|072|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9227|073|S|breathing.||
9227|074|S|   This is not a complete list of possible side effects. If you||
9227|075|S|notice other effects not listed above, contact your doctor or||
9227|076|S|pharmacist.||
9227|077|S|   In the US -||
9227|078|S|   Call your doctor for medical advice about side effects. You||
9227|079|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9227|080|S|www.fda.gov/medwatch.||
9227|081|S|   In Canada - Call your doctor for medical advice about side||
9227|082|S|effects. You may report side effects to Health Canada at||
9227|083|S|1-866-234-2345.||
9227|084|B|||
9227|085|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9227|086|P|pharmacist if you are allergic to it; or if you have any other||
9227|087|P|allergies. This product may contain inactive ingredients, which||
9227|088|P|can cause allergic reactions or other problems. Talk to your||
9227|089|P|pharmacist for more details.||
9227|090|P|   Before using this medication, tell your doctor or pharmacist||
9227|091|P|your medical history, especially of: underactive adrenal gland||
9227|092|P|(Addison's disease), heart disease (such as recent heart attack,||
9227|093|P|heart failure, irregular heartbeat), kidney disease,||
9227|094|P|sodium/potassium-restricted diet, mineral imbalance (such as high||
9227|095|P|sodium/potassium or low calcium levels), dehydration, extra fluid||
9227|096|P|in the body (such as swelling of arms/legs, fluid in the lungs),||
9227|097|P|high blood pressure, stomach/gut problems (such as peptic ulcers,||
9227|098|P|irritable bowel).||
9227|099|P|   Liquid forms of this product may contain sugar. Caution is||
9227|100|P|advised if you have diabetes. Ask your doctor or pharmacist about||
9227|101|P|using this product safely.||
9227|102|P|   Because this medication contains salt (sodium), tell your||
9227|103|P|doctor if you are on a salt-restricted diet.||
9227|104|P|   During pregnancy, this medication should be used only when||
9227|105|P|clearly needed. Discuss the risks and benefits with your doctor.||
9227|106|P|   It is unknown if this drug passes into breast milk. Consult||
9227|107|P|your doctor before breastfeeding.||
9227|108|B|||
9227|109|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9227|110|I|medications work or increase your risk for serious side effects.||
9227|111|I|This document does not contain all possible drug interactions.||
9227|112|I|Keep a list of all the products you use (including||
9227|113|I|prescription/nonprescription drugs and herbal products) and share||
9227|114|I|it with your doctor and pharmacist. Do not start, stop, or change||
9227|115|I|the dosage of any medicines without your doctor's approval.||
9227|116|I|   Some products that may interact with this drug are: antacids||
9227|117|I|that contain aluminum, aspirin and other salicylates (such as||
9227|118|I|salsalate), certain blood pressure medications (including ACE||
9227|119|I|inhibitors such as lisinopril, angiotensin blockers such as||
9227|120|I|losartan), drospirenone, eplerenone, certain heart medications||
9227|121|I|(such as quinidine, digoxin), lithium, potassium supplements,||
9227|122|I|certain "water pills" (potassium-sparing diuretics such as||
9227|123|I|amiloride, spironolactone, triamterene).||
9227|124|I|   If your doctor has told you to take low-dose aspirin to||
9227|125|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
9227|126|I|you should keep taking the aspirin unless your doctor tells you||
9227|127|I|not to. Ask your doctor or pharmacist for more details.||
9227|128|B|||
9227|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9227|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9227|131|O|poison control center right away. US residents can call||
9227|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9227|133|O|Symptoms of overdose may include: slow heartbeat, muscle spasms,||
9227|134|O|seizures.||
9227|135|B|||
9227|136|N|NOTES:  Do not share this medication with others.||
9227|137|N|   Lab and/or medical tests (such as potassium/sodium levels)||
9227|138|N|should be done while you are taking this medication. Keep all||
9227|139|N|medical and lab appointments. Consult your doctor for more||
9227|140|N|details.||
9227|141|B|||
9227|142|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9227|143|D|remember. If it is near the time of the next dose, skip the||
9227|144|D|missed dose. Take your next dose at the regular time. Do not||
9227|145|D|double the dose to catch up.||
9227|146|B|||
9227|147|R|STORAGE:  Store at room temperature away from heat, light, and||
9227|148|R|moisture. Do not freeze. Do not store in the bathroom. Keep all||
9227|149|R|medications away from children and pets.||
9227|150|R|   Do not flush medications down the toilet or pour them into a||
9227|151|R|drain unless instructed to do so. Properly discard this product||
9227|152|R|when it is expired or no longer needed. Consult your pharmacist||
9227|153|R|or local waste disposal company.||
9227|154|B|||
9227|155|A|Information last revised May 2024.||
9227|156|A|Copyright(c) 2025 First Databank, Inc.||
9227|157|B|||
9228|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9228|002|Z|does NOT have all possible information about this product. This||
9228|003|Z|information does not assure that this product is safe, effective,||
9228|004|Z|or appropriate for you. This information is not individual||
9228|005|Z|medical advice and does not substitute for the advice of your||
9228|006|Z|health care professional. Always ask your health care||
9228|007|Z|professional for complete information about this product and your||
9228|008|Z|specific health needs.||
9228|009|B|||
9228|010|T|SOMATROPIN - INJECTION||
9228|011|F|(so-mah-TROW-pin)||
9228|012|B|||
9228|013|C|COMMON BRAND NAME(S): Genotropin, Humatrope, Norditropin,||
9228|014|C|Nutropin, Saizen, Serostim, Zorbtive||
9228|015|B|||
9228|016|U|USES:  Various brands of this medication are used for the||
9228|017|U|treatment of one of the following medical conditions: growth||
9228|018|U|failure, growth hormone deficiency, intestinal disorder (short||
9228|019|U|bowel syndrome) or HIV-related weight loss or wasting.||
9228|020|U|   Somatropin is also used to increase height in children with||
9228|021|U|certain disorders (such as Noonan syndrome, Turner syndrome,||
9228|022|U|idiopathic short stature).||
9228|023|B|||
9228|024|H|HOW TO USE:  Read the Patient Information Leaflet and||
9228|025|H|Instructions for Use if available from your pharmacist before you||
9228|026|H|start using this medication and each time you get a refill. Ask||
9228|027|H|your health care professional how to prepare and use this||
9228|028|H|medication. If you have any questions, ask your doctor or||
9228|029|H|pharmacist.||
9228|030|H|   Inject this medication under the skin as directed by your||
9228|031|H|doctor. Some brands may also be injected into the muscle. Follow||
9228|032|H|your doctor's instructions carefully. The dosage is based on your||
9228|033|H|age, weight, medical condition and response to treatment.||
9228|034|H|   Do not shake the medication. Before using, check this product||
9228|035|H|for particles or discoloration. If either is present, do not use||
9228|036|H|the liquid. Before injecting each dose, clean the skin you are||
9228|037|H|going to inject into (the injection site) with rubbing alcohol.||
9228|038|H|Change the injection site each time to lessen injury under the||
9228|039|H|skin. To lessen bruising, do not rub the injection site after a||
9228|040|H|shot. Learn how to store and discard medical supplies safely.||
9228|041|H|   If you are using a pen device, do not share your pen device||
9228|042|H|with another person, even if the needle is changed. You may give||
9228|043|H|other people a serious infection, or get a serious infection from||
9228|044|H|them.||
9228|045|H|   If this medicine is used for short bowel syndrome, consult||
9228|046|H|your doctor if a special diet (high carbohydrate/low-fat) or the||
9228|047|H|use of nutritional supplements may be helpful.||
9228|048|H|   If this medicine is used for weight loss/muscle wasting, it||
9228|049|H|may take up to 2 weeks to notice the effects of the drug. Do not||
9228|050|H|use more of this medication than prescribed or use it more often||
9228|051|H|since the risk of side effects will be increased.||
9228|052|B|||
9228|053|S|SIDE EFFECTS:  Headache, nausea, vomiting, tiredness, muscle||
9228|054|S|pain, or weakness may occur. If any of these effects last or get||
9228|055|S|worse, tell your doctor or pharmacist promptly.||
9228|056|S|   Remember that this medication has been prescribed because your||
9228|057|S|doctor has judged that the benefit to you is greater than the||
9228|058|S|risk of side effects. Many people using this medication do not||
9228|059|S|have serious side effects.||
9228|060|S|   Tell your doctor right away if you have any serious side||
9228|061|S|effects, including: nausea/vomiting that doesn't stop,||
9228|062|S|development of a limp, unusual tiredness, unusual/unexplained||
9228|063|S|weight gain, cold intolerance, fast/slow heartbeat, ear||
9228|064|S|pain/itching, hearing problems, joint/hip/knee pain,||
9228|065|S|numbness/tingling, unusual increase in thirst or urination,||
9228|066|S|swelling hands/ankles/feet, change in the appearance or size of||
9228|067|S|any mole, severe stomach/abdominal pain.||
9228|068|S|   Get medical help right away if you have any very serious side||
9228|069|S|effects, including: vision problems/changes, seizure, severe||
9228|070|S|headache.||
9228|071|S|   Rare (possibly fatal) lung/breathing problems may be caused by||
9228|072|S|this medication in children with Prader-Willi syndrome. Those at||
9228|073|S|higher risk include males, severely overweight children, or those||
9228|074|S|with serious lung/breathing problems ( such as sleep apnea, lung||
9228|075|S|infections, lung disease). Children should be checked for certain||
9228|076|S|breathing problems (upper airway obstruction) before and during||
9228|077|S|treatment. Heavy snoring or irregular breathing during sleep||
9228|078|S|(sleep apnea) are signs of airway obstruction. Tell the doctor||
9228|079|S|right away if these signs occur. Also report any signs of lung||
9228|080|S|infection, such as fever, cough, or trouble breathing.||
9228|081|S|   Somatropin may increase your risk of getting a tumor or||
9228|082|S|cancer. Discuss the details and the risks and benefits of this||
9228|083|S|medication with your doctor.||
9228|084|S|   A very serious allergic reaction to this drug is rare.||
9228|085|S|However, get medical help right away if you notice any symptoms||
9228|086|S|of a serious allergic reaction, including: rash, itching/severe||
9228|087|S|swelling (especially of the face/tongue/throat), dizziness,||
9228|088|S|trouble breathing.||
9228|089|S|   This is not a complete list of possible side effects. If you||
9228|090|S|notice other effects not listed above, contact your doctor or||
9228|091|S|pharmacist.||
9228|092|S|   In the US -||
9228|093|S|   Call your doctor for medical advice about side effects. You||
9228|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9228|095|S|www.fda.gov/medwatch.||
9228|096|S|   In Canada - Call your doctor for medical advice about side||
9228|097|S|effects. You may report side effects to Health Canada at||
9228|098|S|1-866-234-2345.||
9228|099|B|||
9228|100|P|PRECAUTIONS:  See also Side Effects section.||
9228|101|P|   Before using somatropin, tell your doctor or pharmacist if you||
9228|102|P|are allergic to it; or to lonapegsomatropin; or if you have any||
9228|103|P|other allergies. This product may contain inactive ingredients||
9228|104|P|(such as benzyl alcohol or metacresol found in some brands),||
9228|105|P|which can cause allergic reactions or other problems. Talk to||
9228|106|P|your pharmacist for more details.||
9228|107|P|   Before using this medication, tell your doctor or pharmacist||
9228|108|P|your medical history, especially of: adrenal gland problems, eye||
9228|109|P|problems (such as diabetic retinopathy), recent major||
9228|110|P|surgery/injury, breathing problems, diabetes or family history of||
9228|111|P|diabetes, obesity, kidney disease, cancer/tumor (especially of||
9228|112|P|the head/neck), thyroid problems, back problems (scoliosis).||
9228|113|P|   If you have diabetes, this drug may increase your blood sugar.||
9228|114|P|Check your blood sugar regularly as directed and share the||
9228|115|P|results with your doctor. Tell your doctor right away if you have||
9228|116|P|symptoms of high blood sugar such as increased thirst/urination.||
9228|117|P|Your doctor may need to adjust your diabetes medication, exercise||
9228|118|P|program, or diet.||
9228|119|P|   When this medication is given to newborns, mix with sterile||
9228|120|P|water for injection that does not contain a preservative. A||
9228|121|P|preservative (benzyl alcohol) which may be found in the liquid||
9228|122|P|used to mix this product can rarely cause serious problems||
9228|123|P|(sometimes death), if given by injection to an infant during the||
9228|124|P|first months of life. The risk is greater with lower birth weight||
9228|125|P|infants and is greater with increased amounts of benzyl alcohol.||
9228|126|P|Symptoms include sudden gasping, low blood pressure, or a very||
9228|127|P|slow heartbeat. Report these symptoms to the doctor right away||
9228|128|P|should they occur.||
9228|129|P|   Before having surgery, tell your doctor or dentist about all||
9228|130|P|the products you use (including prescription drugs,||
9228|131|P|nonprescription drugs, and herbal products).||
9228|132|P|   Older adults may be more sensitive to the side effects of this||
9228|133|P|drug, especially effects on blood sugar, or swelling ankles/feet.||
9228|134|P|   During pregnancy, this medication should be used only when||
9228|135|P|clearly needed. Discuss the risks and benefits with your doctor.||
9228|136|P|   It is unknown if this drug passes into breast milk. Consult||
9228|137|P|your doctor before breastfeeding.||
9228|138|B|||
9228|139|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9228|140|I|medications work or increase your risk for serious side effects.||
9228|141|I|This document does not contain all possible drug interactions.||
9228|142|I|Keep a list of all the products you use (including||
9228|143|I|prescription/nonprescription drugs and herbal products) and share||
9228|144|I|it with your doctor and pharmacist. Do not start, stop, or change||
9228|145|I|the dosage of any medicines without your doctor's approval.||
9228|146|I|   Somatropin is very similar to lonapegsomatropin. Do not use||
9228|147|I|medications containing lonapegsomatropin while using somatropin.||
9228|148|B|||
9228|149|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9228|150|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9228|151|O|poison control center right away. US residents can call||
9228|152|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9228|153|O|Symptoms of overdose may include: severe headache, severe||
9228|154|O|nausea/vomiting, signs of low blood sugar (such as sudden||
9228|155|O|sweating, shaking, confusion), ongoing swelling of the hands and||
9228|156|O|feet.||
9228|157|B|||
9228|158|N|NOTES:  Do not share this medication with others.||
9228|159|N|   Lab and/or medical tests (such as eye exams, thyroid function,||
9228|160|N|glucose levels, growth hormone antibody levels) will be done||
9228|161|N|while you are using this medication. Keep all medical and lab||
9228|162|N|appointments. Consult your doctor for more details.||
9228|163|B|||
9228|164|D|MISSED DOSE:  It is important to get each dose of this medication||
9228|165|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9228|166|D|right away for a new dosing schedule. Do not double the dose to||
9228|167|D|catch up.||
9228|168|B|||
9228|169|R|STORAGE:  Consult the product instructions and your pharmacist||
9228|170|R|for storage details. Keep all medications away from children and||
9228|171|R|pets.||
9228|172|R|   Do not flush medications down the toilet or pour them into a||
9228|173|R|drain unless instructed to do so. Properly discard this product||
9228|174|R|when it is expired or no longer needed. Consult your pharmacist||
9228|175|R|or local waste disposal company.||
9228|176|B|||
9228|177|A|Information last revised October 2024.||
9228|178|A|Copyright(c) 2025 First Databank, Inc.||
9228|179|B|||
9230|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9230|002|Z|does NOT have all possible information about this product. This||
9230|003|Z|information does not assure that this product is safe, effective,||
9230|004|Z|or appropriate for you. This information is not individual||
9230|005|Z|medical advice and does not substitute for the advice of your||
9230|006|Z|health care professional. Always ask your health care||
9230|007|Z|professional for complete information about this product and your||
9230|008|Z|specific health needs.||
9230|009|B|||
9230|010|T|TAZAROTENE - TOPICAL||
9230|011|F|(taz-AR-oh-teen)||
9230|012|B|||
9230|013|C|COMMON BRAND NAME(S): Arazlo, Fabior, Tazorac||
9230|014|B|||
9230|015|U|USES:  This medication is used to treat certain skin conditions,||
9230|016|U|including psoriasis and acne. Different brands, dosage forms, and||
9230|017|U|strengths are approved for different uses, so be sure to check||
9230|018|U|the uses for your brand, dosage form, and strength of this||
9230|019|U|medication. Tazarotene is a retinoid product related to Vitamin||
9230|020|U|A. It is thought to work by affecting skin cell growth. For the||
9230|021|U|best effect, this medication should be used with a total skin||
9230|022|U|care program.||
9230|023|B|||
9230|024|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9230|025|H|from your pharmacist before you start using tazarotene and each||
9230|026|H|time you get a refill. If you have any questions, ask your doctor||
9230|027|H|or pharmacist.||
9230|028|H|   This medication is for use on the skin only. Wash and dry your||
9230|029|H|hands before applying the medication. Apply this medication to||
9230|030|H|the skin as directed by your doctor, usually once daily at||
9230|031|H|bedtime. Wash your hands after applying, unless you are treating||
9230|032|H|your hands for psoriasis. If this medication accidentally gets on||
9230|033|H|areas you do not need to treat, wash it off to help prevent skin||
9230|034|H|irritation. Do not apply this medication to skin that is cut,||
9230|035|H|scraped, sunburned, or affected by certain other skin conditions||
9230|036|H|(eczema, seborrheic dermatitis). Avoid getting this medication in||
9230|037|H|your eyes, mouth, or on your eyelids or lips. If this happens,||
9230|038|H|rinse right away with plenty of cool water.||
9230|039|H|   If you are using a product that is for treating psoriasis,||
9230|040|H|apply a thin film to cover only the psoriatic plaques. If a bath||
9230|041|H|or shower is taken before application, make sure skin is dry||
9230|042|H|before applying. If a moisturizer is used, apply it at least an||
9230|043|H|hour before applying this medication.||
9230|044|H|   If you are using a product that is for treating acne, wash and||
9230|045|H|dry the affected area(s). After skin is dry, apply a thin film to||
9230|046|H|acne. If you are using the lotion to treat acne on the face, dot||
9230|047|H|onto the chin, cheeks, nose, and forehead, then gently rub over||
9230|048|H|the entire face. Use enough to cover all of the affected area(s).||
9230|049|H|If you are also using other acne medication (such as benzoyl||
9230|050|H|peroxide) on your skin, apply one product in the morning and one||
9230|051|H|product in the evening to separate the application times. If a||
9230|052|H|moisturizer is used, make sure to allow skin to dry before||
9230|053|H|applying either the moisturizer or tazarotene.||
9230|054|H|   If you are using the foam, shake the can before each use. The||
9230|055|H|foam is flammable until dry. Avoid smoking or being near open||
9230|056|H|flames while using the medication and until the medication has||
9230|057|H|dried.||
9230|058|H|   Do not cover, bandage, or wrap the affected area(s). Do not||
9230|059|H|apply this medication to normal, healthy skin.||
9230|060|H|   Use this medication regularly to get the most benefit from it.||
9230|061|H|To help you remember, use it at the same time each day.||
9230|062|H|   Do not use large amounts or apply this medication more often||
9230|063|H|than directed, or use it for longer than prescribed. Your||
9230|064|H|condition will not improve faster, and your risk of side effects||
9230|065|H|will increase.||
9230|066|H|   Since this drug is absorbed through the skin and may harm an||
9230|067|H|unborn baby, women who are pregnant or who may become pregnant||
9230|068|H|should not handle this medication.||
9230|069|H|   Tell your doctor if your condition does not get better or if||
9230|070|H|it gets worse.||
9230|071|B|||
9230|072|S|SIDE EFFECTS:  Itching, redness, irritation, burning/stinging,||
9230|073|S|scaling, dry skin, or pain at the application site may occur. If||
9230|074|S|any of these effects last or get worse, tell your doctor or||
9230|075|S|pharmacist promptly.||
9230|076|S|   Remember that this medication has been prescribed because your||
9230|077|S|doctor has judged that the benefit to you is greater than the||
9230|078|S|risk of side effects. Many people using this medication do not||
9230|079|S|have serious side effects.||
9230|080|S|   Tell your doctor right away if you have any serious side||
9230|081|S|effects, including: severe redness/irritation/peeling.||
9230|082|S|   A very serious allergic reaction to this drug is rare.||
9230|083|S|However, get medical help right away if you notice any symptoms||
9230|084|S|of a serious allergic reaction, including: rash, itching/swelling||
9230|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9230|086|S|breathing.||
9230|087|S|   This is not a complete list of possible side effects. If you||
9230|088|S|notice other effects not listed above, contact your doctor or||
9230|089|S|pharmacist.||
9230|090|S|   In the US -||
9230|091|S|   Call your doctor for medical advice about side effects. You||
9230|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9230|093|S|www.fda.gov/medwatch.||
9230|094|S|   In Canada - Call your doctor for medical advice about side||
9230|095|S|effects. You may report side effects to Health Canada at||
9230|096|S|1-866-234-2345.||
9230|097|B|||
9230|098|P|PRECAUTIONS:  Before using tazarotene, tell your doctor or||
9230|099|P|pharmacist if you are allergic to it; or to vitamin A-related||
9230|100|P|drugs (other retinoids such as isotretinoin); or if you have any||
9230|101|P|other allergies. This product may contain inactive ingredients,||
9230|102|P|which can cause allergic reactions or other problems. Talk to||
9230|103|P|your pharmacist for more details.||
9230|104|P|   Before using this medication, tell your doctor or pharmacist||
9230|105|P|your medical history, especially of: other skin conditions (such||
9230|106|P|as eczema, seborrheic dermatitis, sunburn, sun sensitivity).||
9230|107|P|   This medication may make you more sensitive to the sun. Limit||
9230|108|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9230|109|P|sunscreen daily and wear protective clothing when outdoors. Tell||
9230|110|P|your doctor right away if you get sunburned or have skin||
9230|111|P|blisters/redness. Wait until your skin has completely recovered||
9230|112|P|from a sunburn before using this medication. Wind or cold weather||
9230|113|P|may also be irritating to the skin while using this medication.||
9230|114|P|   Avoid electrolysis, waxing, and chemical depilatories for hair||
9230|115|P|removal on the treated areas while using this product.||
9230|116|P|   Before having surgery, tell your doctor or dentist about all||
9230|117|P|the products you use (including prescription drugs,||
9230|118|P|nonprescription drugs, and herbal products).||
9230|119|P|   This medication must not be used during pregnancy. It may harm||
9230|120|P|an unborn baby. Your doctor may order a pregnancy test within 2||
9230|121|P|weeks before starting this medication. This medication should be||
9230|122|P|started during a normal menstrual period. Discuss the use of||
9230|123|P|reliable forms of birth control (such as condoms, birth control||
9230|124|P|pills) with your doctor. If you become pregnant or think you may||
9230|125|P|be pregnant, tell your doctor right away.||
9230|126|P|   Since this drug is absorbed through the skin and may harm an||
9230|127|P|unborn baby, women who are pregnant or who may become pregnant||
9230|128|P|should not handle this medication.||
9230|129|P|   It is unknown if this drug passes into breast milk. Consult||
9230|130|P|your doctor before breastfeeding.||
9230|131|B|||
9230|132|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9230|133|I|medications work or increase your risk for serious side effects.||
9230|134|I|This document does not contain all possible drug interactions.||
9230|135|I|Keep a list of all the products you use (including||
9230|136|I|prescription/nonprescription drugs and herbal products) and share||
9230|137|I|it with your doctor and pharmacist. Do not start, stop, or change||
9230|138|I|the dosage of any medicines without your doctor's approval.||
9230|139|I|   Some products that may interact with this drug are: vitamin A||
9230|140|I|products, hair perming solutions, other skin products with strong||
9230|141|I|drying effects, skin products containing alcohol/lime/spice (such||
9230|142|I|as shaving lotions, astringents such as calamine lotion,||
9230|143|I|perfume), soaps/shampoos/cleansers that are medicated/abrasive.||
9230|144|B|||
9230|145|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9230|146|O|has overdosed and has serious symptoms such as passing out or||
9230|147|O|trouble breathing, call 911. Otherwise, call a poison control||
9230|148|O|center right away. US residents can call 1-800-222-1222. Canada||
9230|149|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9230|150|O|include: severe redness/irritation/peeling.||
9230|151|B|||
9230|152|N|NOTES:  Do not share this medication with others.||
9230|153|B|||
9230|154|D|MISSED DOSE:  If you miss a dose, apply it as soon as you||
9230|155|D|remember. If it is near the time of the next dose, skip the||
9230|156|D|missed dose. Apply your next dose at the regular time. Do not||
9230|157|D|apply extra medicine to make up for the missed dose.||
9230|158|B|||
9230|159|R|STORAGE:  Different brands of this medication have different||
9230|160|R|storage needs. Check the product package for instructions on how||
9230|161|R|to store your brand, or ask your pharmacist. Keep all medications||
9230|162|R|away from children and pets.||
9230|163|R|   Do not flush medications down the toilet or pour them into a||
9230|164|R|drain unless instructed to do so. Properly discard this product||
9230|165|R|when it is expired or no longer needed. Consult your pharmacist||
9230|166|R|or local waste disposal company.||
9230|167|B|||
9230|168|A|Information last revised July 2025.||
9230|169|A|Copyright(c) 2025 First Databank, Inc.||
9230|170|B|||
9233|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9233|002|Z|does NOT have all possible information about this product. This||
9233|003|Z|information does not assure that this product is safe, effective,||
9233|004|Z|or appropriate for you. This information is not individual||
9233|005|Z|medical advice and does not substitute for the advice of your||
9233|006|Z|health care professional. Always ask your health care||
9233|007|Z|professional for complete information about this product and your||
9233|008|Z|specific health needs.||
9233|009|B|||
9233|010|T|OCTREOTIDE DEPOT SUSPENSION - INJECTION||
9233|011|F|(ok-TREE-oh-tide)||
9233|012|B|||
9233|013|C|COMMON BRAND NAME(S): Sandostatin LAR||
9233|014|B|||
9233|015|U|USES:  This medication is a long-acting form of octreotide.||
9233|016|U|Octreotide is used to treat severe watery diarrhea and sudden||
9233|017|U|reddening of the face and neck caused by certain types of tumors||
9233|018|U|(such as carcinoid tumors, vasoactive intestinal peptide tumors)||
9233|019|U|that are found usually in the intestines and pancreas. The||
9233|020|U|symptoms occur when these tumors make too much of certain natural||
9233|021|U|substances (hormones). This medication works by blocking the||
9233|022|U|production of these hormones. By decreasing watery diarrhea,||
9233|023|U|octreotide helps to reduce the loss of body fluids and minerals.||
9233|024|U|   Octreotide is also used to treat a certain condition||
9233|025|U|(acromegaly) that occurs when the body makes too much of a||
9233|026|U|certain natural substance called growth hormone. Treating||
9233|027|U|acromegaly helps reduce the risk of serious problems such as||
9233|028|U|diabetes and heart disease. Octreotide works by decreasing how||
9233|029|U|much growth hormone your body makes.||
9233|030|U|   This drug is not a cure for these conditions. This medication||
9233|031|U|is usually used with other treatment (such as surgery, radiation,||
9233|032|U|other drugs).||
9233|033|B|||
9233|034|H|HOW TO USE:  You must respond well to the short-acting form of||
9233|035|H|octreotide before switching to this medication. Consult your||
9233|036|H|doctor or pharmacist.||
9233|037|H|   This medication is given by injection into your buttock muscle||
9233|038|H|as directed by your doctor, usually once every 4 weeks. The||
9233|039|H|dosage is based on your medical condition and response to||
9233|040|H|treatment.||
9233|041|H|   To reduce irritation, change the location of the injection||
9233|042|H|site in the buttocks with each dose. Avoid giving this medication||
9233|043|H|into the muscles of the arm. Doing so causes more pain and||
9233|044|H|irritation.||
9233|045|H|   If you are using this medication at home, learn all||
9233|046|H|preparation and usage instructions from your health care||
9233|047|H|professional. Take this medication out of the refrigerator 30 to||
9233|048|H|60 minutes before mixing. Before using, check this product for||
9233|049|H|particles or discoloration. If either is present, do not use the||
9233|050|H|liquid. Learn how to store and discard medical supplies safely.||
9233|051|H|   Use this medication regularly to get the most benefit from it.||
9233|052|H|To help you remember, mark your calendar with a reminder.||
9233|053|H|   Tell your doctor if your condition does not get better or if||
9233|054|H|it gets worse.||
9233|055|B|||
9233|056|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, stomach upset, gas,||
9233|057|S|bloating, dizziness, or headache may occur. Pain and irritation||
9233|058|S|at the injection site may also occur. If any of these effects||
9233|059|S|last or get worse, tell your doctor or pharmacist promptly.||
9233|060|S|   Remember that this medication has been prescribed because your||
9233|061|S|doctor has judged that the benefit to you is greater than the||
9233|062|S|risk of side effects. Many people using this medication do not||
9233|063|S|have serious side effects.||
9233|064|S|   Tell your doctor right away if you have any serious side||
9233|065|S|effects, including: signs of gallbladder/liver problems (such as||
9233|066|S|fever, nausea/vomiting that doesn't stop, loss of appetite,||
9233|067|S|stomach/abdominal pain, yellowing eyes/skin, dark urine,||
9233|068|S|unexplained pain in the back/right shoulder), signs of||
9233|069|S|underactive thyroid (such as unexplained weight gain, cold||
9233|070|S|intolerance, severe constipation, unusual tiredness,||
9233|071|S|growth/lump/swelling on the front of the neck),||
9233|072|S|slow/fast/irregular heartbeat, weight loss, change in stool||
9233|073|S|color.||
9233|074|S|   This medication may cause changes in blood sugar, especially||
9233|075|S|if you have diabetes. Symptoms of high blood sugar include||
9233|076|S|increased thirst and urination. Symptoms of low blood sugar||
9233|077|S|include sudden sweating, shaking, fast heartbeat, hunger, blurred||
9233|078|S|vision, dizziness, or tingling hands/feet. Tell your doctor right||
9233|079|S|away if you experience symptoms of high or low blood sugar while||
9233|080|S|using this medication. If you already have diabetes, check your||
9233|081|S|blood sugar regularly as directed and share the results with your||
9233|082|S|doctor. Your doctor may need to adjust your diabetes medication,||
9233|083|S|exercise program, or diet.||
9233|084|S|   A very serious allergic reaction to this drug is rare.||
9233|085|S|However, get medical help right away if you notice any symptoms||
9233|086|S|of a serious allergic reaction, including: rash, itching/swelling||
9233|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9233|088|S|breathing.||
9233|089|S|   This is not a complete list of possible side effects. If you||
9233|090|S|notice other effects not listed above, contact your doctor or||
9233|091|S|pharmacist.||
9233|092|S|   In the US -||
9233|093|S|   Call your doctor for medical advice about side effects. You||
9233|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9233|095|S|www.fda.gov/medwatch.||
9233|096|S|   In Canada - Call your doctor for medical advice about side||
9233|097|S|effects. You may report side effects to Health Canada at||
9233|098|S|1-866-234-2345.||
9233|099|B|||
9233|100|P|PRECAUTIONS:  Before using octreotide, tell your doctor or||
9233|101|P|pharmacist if you are allergic to it; or if you have any other||
9233|102|P|allergies. This product may contain inactive ingredients, which||
9233|103|P|can cause allergic reactions or other problems. Talk to your||
9233|104|P|pharmacist for more details.||
9233|105|P|   Before using this medication, tell your doctor or pharmacist||
9233|106|P|your medical history, especially of: kidney disease, liver||
9233|107|P|disease, diabetes, thyroid problems, gallbladder problems (such||
9233|108|P|as gallstones), heart problems (such as heart failure), nutrition||
9233|109|P|problems (such as decreased fat absorption, vitamin B12||
9233|110|P|deficiency).||
9233|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9233|112|P|can make you more dizzy. Do not drive, use machinery, or do||
9233|113|P|anything that needs alertness until you can do it safely. Limit||
9233|114|P|alcoholic beverages. Talk to your doctor if you are using||
9233|115|P|marijuana (cannabis).||
9233|116|P|   Before having surgery, tell your doctor or dentist about all||
9233|117|P|the products you use (including prescription drugs,||
9233|118|P|nonprescription drugs, and herbal products).||
9233|119|P|   If used for a long time (such as longer than 1 year), this||
9233|120|P|medication may slow a child's growth rate. However, the growth||
9233|121|P|rate catches up after treatment with the drug is stopped. Consult||
9233|122|P|your doctor for more information.||
9233|123|P|   Treatment with this medication may improve fertility in women||
9233|124|P|and may lead to unintended pregnancy. Ask your doctor for more||
9233|125|P|details.||
9233|126|P|   During pregnancy, this medication should be used only when||
9233|127|P|clearly needed. Discuss the risks and benefits with your doctor.||
9233|128|P|   It is unknown if this medication passes into breast milk.||
9233|129|P|Consult your doctor before breastfeeding.||
9233|130|B|||
9233|131|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9233|132|I|medications work or increase your risk for serious side effects.||
9233|133|I|This document does not contain all possible drug interactions.||
9233|134|I|Keep a list of all the products you use (including||
9233|135|I|prescription/nonprescription drugs and herbal products) and share||
9233|136|I|it with your doctor and pharmacist. Do not start, stop, or change||
9233|137|I|the dosage of any medicines without your doctor's approval.||
9233|138|B|||
9233|139|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9233|140|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9233|141|O|poison control center right away. US residents can call||
9233|142|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9233|143|B|||
9233|144|N|NOTES:  Do not share this medication with others.||
9233|145|N|   Lab and/or medical tests (such as blood sugar, thyroid||
9233|146|N|function, hormone levels, vitamin B12 levels) should be done||
9233|147|N|before you start using this medication and while you are using||
9233|148|N|it. Keep all medical and lab appointments. Consult your doctor||
9233|149|N|for more details.||
9233|150|B|||
9233|151|D|MISSED DOSE:  It is important to get each dose of this medication||
9233|152|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9233|153|D|right away for a new dosing schedule. Do not double the dose to||
9233|154|D|catch up.||
9233|155|B|||
9233|156|R|STORAGE:  Store in the refrigerator away from light. Do not||
9233|157|R|freeze. Discard any unused portion of the vial or syringe. Keep||
9233|158|R|all medications away from children and pets.||
9233|159|R|   Do not flush medications down the toilet or pour them into a||
9233|160|R|drain unless instructed to do so. Properly discard this product||
9233|161|R|when it is expired or no longer needed. Consult your pharmacist||
9233|162|R|or local waste disposal company.||
9233|163|B|||
9233|164|A|Information last revised October 2025.||
9233|165|A|Copyright(c) 2025 First Databank, Inc.||
9233|166|B|||
9234|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9234|002|Z|does NOT have all possible information about this product. This||
9234|003|Z|information does not assure that this product is safe, effective,||
9234|004|Z|or appropriate for you. This information is not individual||
9234|005|Z|medical advice and does not substitute for the advice of your||
9234|006|Z|health care professional. Always ask your health care||
9234|007|Z|professional for complete information about this product and your||
9234|008|Z|specific health needs.||
9234|009|B|||
9234|010|T|DIAZOXIDE - ORAL||
9234|011|F|(dye-uh-ZOX-ide)||
9234|012|B|||
9234|013|C|COMMON BRAND NAME(S): Proglycem||
9234|014|B|||
9234|015|U|USES:  This medication is used to treat very low blood sugar||
9234|016|U|(hypoglycemia). Certain conditions (such as tumor on the||
9234|017|U|pancreas, cancer, leucine sensitivity) can cause the release of||
9234|018|U|too much insulin. Insulin is a natural substance that lowers||
9234|019|U|blood sugar. This drug works by preventing insulin release from||
9234|020|U|the pancreas, helping to return the blood sugar to normal levels.||
9234|021|U|Diazoxide is a thiazide drug, but has no diuretic ("water pill")||
9234|022|U|effects like other thiazides.||
9234|023|U|   Diazoxide should not be used to treat low blood sugar from||
9234|024|U|poor nutrition/diet (functional hypoglycemia).||
9234|025|B|||
9234|026|V|OTHER USES:  This section contains uses of this drug that are not||
9234|027|V|listed in the approved professional labeling for the drug but||
9234|028|V|that may be prescribed by your health care professional. Use this||
9234|029|V|drug for a condition that is listed in this section only if it||
9234|030|V|has been so prescribed by your health care professional.||
9234|031|V|   Diazoxide is also available in a different form||
9234|032|V|(extended-release tablet) to treat extreme hunger, non-stop||
9234|033|V|thoughts about food, and non-stop need to eat that cannot be||
9234|034|V|satisfied with food (hyperphagia) in people with a certain||
9234|035|V|genetic disorder (Prader-Willi syndrome). Do not take this||
9234|036|V|medication with any other product that contains diazoxide.||
9234|037|B|||
9234|038|H|HOW TO USE:  Take this medication by mouth as directed by your||
9234|039|H|doctor, usually 2 to 3 times daily (every 8 to 12 hours). Your||
9234|040|H|doctor may direct you to follow a special diet for your||
9234|041|H|condition. Consult your doctor, pharmacist, or dietician for more||
9234|042|H|details.||
9234|043|H|   Do not switch between the capsule and suspension form of this||
9234|044|H|medication without talking with your doctor first. Your dose may||
9234|045|H|need to be adjusted. If you are using the suspension, shake the||
9234|046|H|bottle well before each dose. Carefully measure the dose using a||
9234|047|H|special measuring device/spoon. Do not use a household spoon||
9234|048|H|because you may not get the correct dose. If the suspension has||
9234|049|H|turned a dark color, do not use and discard it.||
9234|050|H|   The dosage is based on your weight, medical condition, and||
9234|051|H|response to treatment. You will need to check your blood sugar||
9234|052|H|and check your urine for sugar and ketones regularly as directed||
9234|053|H|and share the results with your doctor. Your doctor will adjust||
9234|054|H|the dose based on these tests. Your doctor may change your dose||
9234|055|H|often when you first start taking the drug to find the best dose||
9234|056|H|for you. Follow your doctor's directions carefully.||
9234|057|H|   Use this medication regularly to get the most benefit from it.||
9234|058|H|To help you remember, take it at the same times each day.||
9234|059|H|   Tell your doctor if your condition lasts or gets worse after 2||
9234|060|H|to 3 weeks.||
9234|061|B|||
9234|062|S|SIDE EFFECTS:  Nausea, loss of appetite, stomach upset, and||
9234|063|S|changes in sense of taste may occur. If any of these effects last||
9234|064|S|or get worse, tell your doctor or pharmacist promptly.||
9234|065|S|   Unusual growth of body hair, especially on the||
9234|066|S|forehead/back/arms/legs, may occur. This is usually not permanent||
9234|067|S|and will go away when the drug is stopped.||
9234|068|S|   Remember that this medication has been prescribed because your||
9234|069|S|doctor has judged that the benefit to you is greater than the||
9234|070|S|risk of side effects. Many people using this medication do not||
9234|071|S|have serious side effects.||
9234|072|S|   This medication can cause your body to hold onto salt and||
9234|073|S|water which may lead to serious heart problems. Tell your doctor||
9234|074|S|right away if any of these serious side effects happen to you:||
9234|075|S|swelling of arms/legs/hands/feet, unexplained weight gain,||
9234|076|S|shortness of breath, unusual tiredness.||
9234|077|S|   This medication may cause your blood sugar to become too high.||
9234|078|S|Checking your blood sugar and urine for sugar/ketones regularly||
9234|079|S|and telling your doctor the results will help prevent this side||
9234|080|S|effect. High blood sugar can be very serious and worsen quickly.||
9234|081|S|Tell your doctor right away if any of these signs of very high||
9234|082|S|blood sugar occur: frequent urination, unusual thirst,||
9234|083|S|nausea/vomiting that doesn't go away, abdominal pain, fruity||
9234|084|S|breath odor, deep/rapid breathing, unusual weight loss, unusual||
9234|085|S|weakness/tiredness.||
9234|086|S|   Tell your doctor right away if you have any serious side||
9234|087|S|effects, including: easy bruising/bleeding, fainting,||
9234|088|S|fast/pounding heartbeat.||
9234|089|S|   A very serious allergic reaction to this drug is rare.||
9234|090|S|However, get medical help right away if you notice any symptoms||
9234|091|S|of a serious allergic reaction, including: rash, itching/swelling||
9234|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9234|093|S|breathing.||
9234|094|S|   This is not a complete list of possible side effects. If you||
9234|095|S|notice other effects not listed above, contact your doctor or||
9234|096|S|pharmacist.||
9234|097|S|   In the US -||
9234|098|S|   Call your doctor for medical advice about side effects. You||
9234|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9234|100|S|www.fda.gov/medwatch.||
9234|101|S|   In Canada - Call your doctor for medical advice about side||
9234|102|S|effects. You may report side effects to Health Canada at||
9234|103|S|1-866-234-2345.||
9234|104|B|||
9234|105|P|PRECAUTIONS:  Before taking diazoxide, tell your doctor or||
9234|106|P|pharmacist if you are allergic to it; or to other thiazides (such||
9234|107|P|as hydrochlorothiazide); or if you have any other allergies. This||
9234|108|P|product may contain inactive ingredients, which can cause||
9234|109|P|allergic reactions or other problems. Talk to your pharmacist for||
9234|110|P|more details.||
9234|111|P|   Before using this medication, tell your doctor or pharmacist||
9234|112|P|your medical history, especially of: low blood minerals (low||
9234|113|P|potassium blood levels), diabetes, heart disease (such as heart||
9234|114|P|failure, past heart attack), kidney disease, gout, liver disease.||
9234|115|P|   The suspension (liquid) form of this medication contains||
9234|116|P|alcohol. Caution is advised if you have diabetes, liver disease,||
9234|117|P|or any other condition that requires you to limit/avoid alcohol||
9234|118|P|in your diet. Ask your doctor or pharmacist about using this||
9234|119|P|product safely.||
9234|120|P|   This medication may raise your blood sugar too high under||
9234|121|P|certain conditions. For example, your body may need more insulin||
9234|122|P|while you are under stress due to infection, surgery, or injury.||
9234|123|P|Certain medications (such as corticosteroids like||
9234|124|P|hydrocortisone/prednisone, hormones such as birth control pills)||
9234|125|P|may raise your blood sugar. Your dose may need to be adjusted.||
9234|126|P|Consult your doctor for more details. Tell your doctor right away||
9234|127|P|if any signs of high blood sugar occur (see Side Effects||
9234|128|P|section).||
9234|129|P|   Before having surgery, tell your doctor or dentist about all||
9234|130|P|the products you use (including prescription drugs,||
9234|131|P|nonprescription drugs, and herbal products).||
9234|132|P|   During pregnancy, this medication should be used only when||
9234|133|P|clearly needed. Discuss the risks and benefits with your doctor.||
9234|134|P|   This medication passes into breast milk. Consult your doctor||
9234|135|P|before breastfeeding.||
9234|136|B|||
9234|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9234|138|I|medications work or increase your risk for serious side effects.||
9234|139|I|This document does not contain all possible drug interactions.||
9234|140|I|Keep a list of all the products you use (including||
9234|141|I|prescription/nonprescription drugs and herbal products) and share||
9234|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
9234|143|I|the dosage of any medicines without your doctor's approval.||
9234|144|I|   This medication may interfere with certain lab tests (such as||
9234|145|I|a glucagon test), possibly causing false test results. Make sure||
9234|146|I|lab personnel and all your doctors know you use this drug.||
9234|147|B|||
9234|148|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9234|149|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9234|150|O|poison control center right away. US residents can call||
9234|151|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9234|152|O|Symptoms of overdose may include: frequent urination, unusual||
9234|153|O|thirst, fruity breath odor.||
9234|154|B|||
9234|155|N|NOTES:  Do not share this medication with others.||
9234|156|N|   For best results, this medication should be used along with a||
9234|157|N|doctor-approved diet plan. Consult your doctor for more details.||
9234|158|N|   Lab and/or medical tests (such as blood sugar, urine||
9234|159|N|sugar/ketones, kidney function, complete blood count,||
9234|160|N|potassium/uric acid levels) should be done while you are taking||
9234|161|N|this medication. Keep all medical and lab appointments. Consult||
9234|162|N|your doctor for more details.||
9234|163|B|||
9234|164|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9234|165|D|remember. If it is near the time of the next dose, skip the||
9234|166|D|missed dose. Take your next dose at the regular time. Do not||
9234|167|D|double the dose to catch up.||
9234|168|B|||
9234|169|R|STORAGE:  Store at room temperature away from light and moisture.||
9234|170|R|Do not store in the bathroom. Keep all medications away from||
9234|171|R|children and pets.||
9234|172|R|   Do not flush medications down the toilet or pour them into a||
9234|173|R|drain unless instructed to do so. Properly discard this product||
9234|174|R|when it is expired or no longer needed. Consult your pharmacist||
9234|175|R|or local waste disposal company.||
9234|176|B|||
9234|177|A|Information last revised July 2025.||
9234|178|A|Copyright(c) 2025 First Databank, Inc.||
9234|179|B|||
9237|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9237|002|Z|does NOT have all possible information about this product. This||
9237|003|Z|information does not assure that this product is safe, effective,||
9237|004|Z|or appropriate for you. This information is not individual||
9237|005|Z|medical advice and does not substitute for the advice of your||
9237|006|Z|health care professional. Always ask your health care||
9237|007|Z|professional for complete information about this product and your||
9237|008|Z|specific health needs.||
9237|009|B|||
9237|010|T|CEVIMELINE - ORAL||
9237|011|F|(seh-VIMM-eh-leen)||
9237|012|B|||
9237|013|C|COMMON BRAND NAME(S): Evoxac||
9237|014|B|||
9237|015|U|USES:  This medication is used to treat symptoms of dry mouth due||
9237|016|U|to a certain immune disease (Sjogren's syndrome). Cevimeline||
9237|017|U|belongs to a class of drugs known as cholinergic agonists. It||
9237|018|U|works by stimulating certain nerves to increase the amount of||
9237|019|U|saliva you produce, making it easier and more comfortable to||
9237|020|U|speak and swallow.||
9237|021|B|||
9237|022|H|HOW TO USE:  Take this medication by mouth with or without food||
9237|023|H|as directed by your doctor, usually 3 times daily.||
9237|024|H|   Dosage is based on your medical condition and response to||
9237|025|H|treatment.||
9237|026|H|   Use this medication regularly to get the most benefit from it.||
9237|027|H|To help you remember, take it at the same times each day.||
9237|028|H|   You may continue to drink water or use saliva substitutes as||
9237|029|H|needed for moisture in your mouth.||
9237|030|H|   You may start to feel some benefit in 1 to 2 weeks. However,||
9237|031|H|it may take up to 6 weeks to feel the full benefit. Tell your||
9237|032|H|doctor if your condition lasts or gets worse.||
9237|033|B|||
9237|034|S|SIDE EFFECTS:  Sweating, nausea, runny nose, flushing, frequent||
9237|035|S|urge to urinate, dizziness, weakness, diarrhea, and blurred||
9237|036|S|vision may occur. If any of these effects last or get worse, tell||
9237|037|S|your doctor or pharmacist promptly.||
9237|038|S|   This medication may cause an increase in tears. This can be||
9237|039|S|helpful if you have dry eyes. Tell your doctor if runny eyes||
9237|040|S|become a problem.||
9237|041|S|   Remember that this medication has been prescribed because your||
9237|042|S|doctor has judged that the benefit to you is greater than the||
9237|043|S|risk of side effects. Many people using this medication do not||
9237|044|S|have serious side effects.||
9237|045|S|   Tell your doctor right away if you have any serious side||
9237|046|S|effects, including: slow/fast/irregular heartbeat, shakiness||
9237|047|S|(tremor), fainting, lung problems (such as increased||
9237|048|S|wheezing/cough/phlegm), mental/mood changes (such as confusion,||
9237|049|S|agitation), severe stomach/abdominal pain.||
9237|050|S|   A very serious allergic reaction to this drug is rare.||
9237|051|S|However, get medical help right away if you notice any symptoms||
9237|052|S|of a serious allergic reaction, including: rash, itching/swelling||
9237|053|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9237|054|S|breathing.||
9237|055|S|   This is not a complete list of possible side effects. If you||
9237|056|S|notice other effects not listed above, contact your doctor or||
9237|057|S|pharmacist.||
9237|058|S|   In the US -||
9237|059|S|   Call your doctor for medical advice about side effects. You||
9237|060|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9237|061|S|www.fda.gov/medwatch.||
9237|062|S|   In Canada - Call your doctor for medical advice about side||
9237|063|S|effects. You may report side effects to Health Canada at||
9237|064|S|1-866-234-2345.||
9237|065|B|||
9237|066|P|PRECAUTIONS:  Before taking cevimeline, tell your doctor or||
9237|067|P|pharmacist if you are allergic to it; or if you have any other||
9237|068|P|allergies. This product may contain inactive ingredients, which||
9237|069|P|can cause allergic reactions or other problems. Talk to your||
9237|070|P|pharmacist for more details.||
9237|071|P|   Before using this medication, tell your doctor or pharmacist||
9237|072|P|your medical history, especially of: breathing problems (such as||
9237|073|P|asthma, chronic bronchitis, chronic obstructive pulmonary||
9237|074|P|disease-COPD), certain eye conditions (such as night blindness,||
9237|075|P|acute iritis, narrow-angle glaucoma), heart disease (such as||
9237|076|P|chest pain, heart failure, heart attack, slow heartbeat), low or||
9237|077|P|high blood pressure, liver problems, gallbladder disease (such as||
9237|078|P|gallstones), kidney stones, mental/mood disorders (such as||
9237|079|P|depression, psychoses, thinking/understanding problems like||
9237|080|P|dementia, Alzheimer's), stomach problems (such as chronic||
9237|081|P|heartburn, ulcer).||
9237|082|P|   This drug may make you dizzy or cause vision problems,||
9237|083|P|especially at night. Alcohol or marijuana (cannabis) can make you||
9237|084|P|more dizzy. Do not drive, use machinery, or do anything that||
9237|085|P|needs alertness or clear vision, especially at night, until you||
9237|086|P|can do it safely. Limit alcoholic beverages. Talk to your doctor||
9237|087|P|if you are using marijuana (cannabis).||
9237|088|P|   If cevimeline makes you sweat heavily, drink plenty of fluids||
9237|089|P|so that you do not become dehydrated. If you are unable to drink||
9237|090|P|enough fluids, talk with your doctor right away.||
9237|091|P|   Before having surgery, tell your doctor or dentist about all||
9237|092|P|the products you use (including prescription drugs,||
9237|093|P|nonprescription drugs, and herbal products).||
9237|094|P|   During pregnancy, this medication should be used only when||
9237|095|P|clearly needed. Discuss the risks and benefits with your doctor.||
9237|096|P|   It is unknown if this drug passes into breast milk. Consult||
9237|097|P|your doctor before breastfeeding.||
9237|098|B|||
9237|099|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9237|100|I|medications work or increase your risk for serious side effects.||
9237|101|I|This document does not contain all possible drug interactions.||
9237|102|I|Keep a list of all the products you use (including||
9237|103|I|prescription/nonprescription drugs and herbal products) and share||
9237|104|I|it with your doctor and pharmacist. Do not start, stop, or change||
9237|105|I|the dosage of any medicines without your doctor's approval.||
9237|106|I|   Some products that may interact with this drug include: beta||
9237|107|I|blockers (such as metoprolol, atenolol).||
9237|108|I|   Other medications can affect the removal of cevimeline from||
9237|109|I|your body, which may affect how cevimeline works. Examples||
9237|110|I|include cimetidine, amiodarone, ritonavir, fluoxetine, among||
9237|111|I|others.||
9237|112|B|||
9237|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9237|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9237|115|O|poison control center right away. US residents can call||
9237|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9237|117|O|Symptoms of overdose may include: extreme sweating, shakiness,||
9237|118|O|slowed/irregular heartbeat, severe breathing problems, confusion,||
9237|119|O|fainting, stomach/abdominal cramping.||
9237|120|B|||
9237|121|N|NOTES:  Do not share this medication with others.||
9237|122|B|||
9237|123|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9237|124|D|remember. If it is near the time of the next dose, skip the||
9237|125|D|missed dose. Take your next dose at the regular time. Do not||
9237|126|D|double the dose to catch up.||
9237|127|B|||
9237|128|R|STORAGE:  Store at room temperature away from light and moisture.||
9237|129|R|Do not store in the bathroom. Keep all medications away from||
9237|130|R|children and pets.||
9237|131|R|   Do not flush medications down the toilet or pour them into a||
9237|132|R|drain unless instructed to do so. Properly discard this product||
9237|133|R|when it is expired or no longer needed. Consult your pharmacist||
9237|134|R|or local waste disposal company.||
9237|135|B|||
9237|136|A|Information last revised May 2024.||
9237|137|A|Copyright(c) 2025 First Databank, Inc.||
9237|138|B|||
9244|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9244|002|Z|does NOT have all possible information about this product. This||
9244|003|Z|information does not assure that this product is safe, effective,||
9244|004|Z|or appropriate for you. This information is not individual||
9244|005|Z|medical advice and does not substitute for the advice of your||
9244|006|Z|health care professional. Always ask your health care||
9244|007|Z|professional for complete information about this product and your||
9244|008|Z|specific health needs.||
9244|009|B|||
9244|010|T|DIAZEPAM - INJECTION||
9244|011|F|(dye-AZ-e-pam)||
9244|012|B|||
9244|013|C|COMMON BRAND NAME(S): Valium||
9244|014|B|||
9244|015|W|WARNING:  Diazepam has a risk for abuse and addiction, which can||
9244|016|W|lead to overdose and death. Using this medication with alcohol or||
9244|017|W|other drugs that can cause drowsiness or breathing problems||
9244|018|W|(especially opioid medications such as codeine, hydrocodone) may||
9244|019|W|cause very serious side effects, including death. To lower your||
9244|020|W|risk, your doctor should have you use the smallest dose of||
9244|021|W|diazepam that works, and use it for the shortest possible time.||
9244|022|W|Be sure you know how to use diazepam and what other drugs you||
9244|023|W|should avoid taking with it. See also Drug Interactions section.||
9244|024|W|Get medical help right away if any of these very serious side||
9244|025|W|effects occur: slow/shallow breathing, unusual lightheadedness,||
9244|026|W|severe drowsiness/dizziness, difficulty waking up.||
9244|027|W|   Suddenly stopping this medication may cause serious (possibly||
9244|028|W|fatal) withdrawal, especially if you have used it for a long time||
9244|029|W|or in high doses. To prevent withdrawal, your doctor may lower||
9244|030|W|your dose slowly. Tell your doctor or pharmacist right away if||
9244|031|W|you have any withdrawal symptoms such as headaches, trouble||
9244|032|W|sleeping, restlessness, hallucinations/confusion, depression,||
9244|033|W|nausea, or seizures. Withdrawal symptoms may sometimes last weeks||
9244|034|W|to months.||
9244|035|B|||
9244|036|U|USES:  Diazepam is used to treat anxiety, muscle spasms, and||
9244|037|U|alcohol withdrawal. The injection form is used when prompt relief||
9244|038|U|is desired or when the medication cannot be taken by mouth.||
9244|039|U|   This medication is also used for the short-term treatment of||
9244|040|U|serious seizures that do not stop (status epilepticus). It is not||
9244|041|U|for ongoing daily use to prevent seizures.||
9244|042|U|   Diazepam is also used before a surgery or procedure to cause||
9244|043|U|drowsiness, decrease anxiety, and to help the patient forget what||
9244|044|U|happened during the surgery/procedure.||
9244|045|U|   This medication works by calming the brain and nerves.||
9244|046|U|Diazepam belongs to a class of drugs known as benzodiazepines.||
9244|047|B|||
9244|048|H|HOW TO USE:  See also Warning section.||
9244|049|H|   This medication is given by injection into a vein or deep into||
9244|050|H|a muscle as directed by your doctor. You should be closely||
9244|051|H|monitored for several hours after receiving this medication.||
9244|052|H|   If you are using this medication at home, learn all||
9244|053|H|preparation and usage instructions from your health care||
9244|054|H|professional. Before using, check this product for particles or||
9244|055|H|discoloration. If either is present, do not use the liquid. Learn||
9244|056|H|how to store and discard medical supplies safely.||
9244|057|H|   The dosage is based on your medical condition, age, and||
9244|058|H|response to treatment. Giving the medication too fast into a vein||
9244|059|H|can cause serious side effects. If giving this medication into a||
9244|060|H|vein, inject it slowly into a large vein. Do not inject this||
9244|061|H|medication into an artery or into the skin.||
9244|062|H|   When this medication is used for a long time, it may not work||
9244|063|H|as well. Talk with your doctor if this medication stops working||
9244|064|H|well.||
9244|065|H|   Though it helps many people, this medication may sometimes||
9244|066|H|cause addiction. This risk may be higher if you have a substance||
9244|067|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
9244|068|H|Take this medication exactly as prescribed to lower the risk of||
9244|069|H|addiction. Ask your doctor or pharmacist for more details.||
9244|070|B|||
9244|071|S|SIDE EFFECTS:  See also Warning section.||
9244|072|S|   Drowsiness, dizziness, blurred vision, unsteadiness, or||
9244|073|S|pain/burning/redness at the injection site may occur. If any of||
9244|074|S|these effects last or get worse, tell your doctor or pharmacist||
9244|075|S|promptly.||
9244|076|S|   Remember that this medication has been prescribed because your||
9244|077|S|doctor has judged that the benefit to you is greater than the||
9244|078|S|risk of side effects. Many people using this medication do not||
9244|079|S|have serious side effects.||
9244|080|S|   Tell your doctor right away if you have any serious side||
9244|081|S|effects, including: mental/mood changes (such as memory problems,||
9244|082|S|agitation, hallucinations, confusion, restlessness, depression),||
9244|083|S|trouble speaking, trouble walking, muscle weakness, shaking||
9244|084|S|(tremors), trouble urinating, yellowing eyes/skin, signs of||
9244|085|S|infection (such as sore throat that doesn't go away, fever,||
9244|086|S|chills), fainting, slow/fast/irregular heartbeat.||
9244|087|S|   Get medical help right away if you have any very serious side||
9244|088|S|effects, including: slow/shallow breathing, chest pain.||
9244|089|S|   A very serious allergic reaction to this drug is rare.||
9244|090|S|However, get medical help right away if you notice any symptoms||
9244|091|S|of a serious allergic reaction, including: rash, itching/swelling||
9244|092|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9244|093|S|breathing.||
9244|094|S|   This is not a complete list of possible side effects. If you||
9244|095|S|notice other effects not listed above, contact your doctor or||
9244|096|S|pharmacist.||
9244|097|S|   In the US -||
9244|098|S|   Call your doctor for medical advice about side effects. You||
9244|099|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9244|100|S|www.fda.gov/medwatch.||
9244|101|S|   In Canada - Call your doctor for medical advice about side||
9244|102|S|effects. You may report side effects to Health Canada at||
9244|103|S|1-866-234-2345.||
9244|104|B|||
9244|105|P|PRECAUTIONS:  Before using diazepam, tell your doctor or||
9244|106|P|pharmacist if you are allergic to it; or to other benzodiazepines||
9244|107|P|(such as oxazepam, temazepam); or if you have any other||
9244|108|P|allergies. This product may contain inactive ingredients, which||
9244|109|P|can cause allergic reactions or other problems. Talk to your||
9244|110|P|pharmacist for more details.||
9244|111|P|   Before using this medication, tell your doctor or pharmacist||
9244|112|P|your medical history, especially of: a certain muscle disease||
9244|113|P|(myasthenia gravis), lung/breathing problems (such as COPD, sleep||
9244|114|P|apnea), mental/mood disorders (such as depression, thoughts of||
9244|115|P|suicide, psychosis), personal or family history of a substance||
9244|116|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
9244|117|P|glaucoma, heart disease, liver disease, kidney disease, brain||
9244|118|P|problems that could affect breathing (such as decreased||
9244|119|P|consciousness, head injury).||
9244|120|P|   This drug may make you dizzy or drowsy or blur your vision.||
9244|121|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9244|122|P|drowsy. Do not drive, use machinery, or do anything that needs||
9244|123|P|alertness or clear vision until you can do it safely. Avoid||
9244|124|P|alcoholic beverages. Talk to your doctor if you are using||
9244|125|P|marijuana (cannabis).||
9244|126|P|   For some children, instead of having a calming effect,||
9244|127|P|diazepam may have the opposite effect, causing mental/mood||
9244|128|P|changes (such as agitation, hallucinations, restlessness).||
9244|129|P|   Older adults may be more sensitive to the side effects of this||
9244|130|P|drug, especially drowsiness and loss of coordination. These side||
9244|131|P|effects can increase the risk of falling. For some older adults,||
9244|132|P|instead of having a calming effect, diazepam may have the||
9244|133|P|opposite effect, causing mental/mood changes (such as agitation,||
9244|134|P|hallucinations, restlessness).||
9244|135|P|   Tell your doctor if you are pregnant or plan to become||
9244|136|P|pregnant. You should not become pregnant while using diazepam.||
9244|137|P|Diazepam may harm an unborn baby. Newborn babies of mothers who||
9244|138|P|receive this medication late in pregnancy may have symptoms such||
9244|139|P|as slow/shallow breathing, nonstop crying, shaking, or trouble||
9244|140|P|feeding. If you become pregnant, talk to your doctor right away||
9244|141|P|about the risks and benefits of this medication.||
9244|142|P|   This medication passes into breast milk and may have||
9244|143|P|undesirable effects on a nursing infant. Breastfeeding is not||
9244|144|P|recommended while using this medication. Consult your doctor||
9244|145|P|before breastfeeding.||
9244|146|B|||
9244|147|I|DRUG INTERACTIONS:  See also Warning section.||
9244|148|I|   Drug interactions may change how your medications work or||
9244|149|I|increase your risk for serious side effects. This document does||
9244|150|I|not contain all possible drug interactions. Keep a list of all||
9244|151|I|the products you use (including prescription/nonprescription||
9244|152|I|drugs and herbal products) and share it with your doctor and||
9244|153|I|pharmacist. Do not start, stop, or change the dosage of any||
9244|154|I|medicines without your doctor's approval.||
9244|155|I|   Some products that may interact with this drug include:||
9244|156|I|clozapine, fluvoxamine, orlistat, sodium oxybate.||
9244|157|I|   The risk of serious side effects (such as slow/shallow||
9244|158|I|breathing, severe drowsiness/dizziness) may be increased if this||
9244|159|I|medication is used with other products that may also cause||
9244|160|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
9244|161|I|if you are taking other products such as opioid pain or cough||
9244|162|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9244|163|I|(cannabis), other drugs for sleep or anxiety (such as alprazolam,||
9244|164|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9244|165|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
9244|166|I|diphenhydramine).||
9244|167|I|   Check the labels on all your medicines (such as allergy or||
9244|168|I|cough-and-cold products) because they may contain ingredients||
9244|169|I|that cause drowsiness. Ask your pharmacist about using those||
9244|170|I|products safely.||
9244|171|B|||
9244|172|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9244|173|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9244|174|O|poison control center right away. US residents can call||
9244|175|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9244|176|O|Symptoms of overdose may include: severe drowsiness, slow||
9244|177|O|reflexes, slow/shallow breathing, fainting, loss of||
9244|178|O|consciousness.||
9244|179|B|||
9244|180|N|NOTES:  Do not share this medication with others. Sharing it is||
9244|181|N|against the law.||
9244|182|B|||
9244|183|D|MISSED DOSE:  Not applicable. This medication is not usually||
9244|184|D|given on a regular schedule.||
9244|185|B|||
9244|186|R|STORAGE:  Store at room temperature away from light. Keep all||
9244|187|R|medications away from children and pets.||
9244|188|R|   Do not flush medications down the toilet or pour them into a||
9244|189|R|drain unless instructed to do so. Properly discard this product||
9244|190|R|when it is expired or no longer needed. Consult your pharmacist||
9244|191|R|or local waste disposal company.||
9244|192|B|||
9244|193|A|Information last revised December 2024.||
9244|194|A|Copyright(c) 2025 First Databank, Inc.||
9244|195|B|||
9251|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9251|002|Z|does NOT have all possible information about this product. This||
9251|003|Z|information does not assure that this product is safe, effective,||
9251|004|Z|or appropriate for you. This information is not individual||
9251|005|Z|medical advice and does not substitute for the advice of your||
9251|006|Z|health care professional. Always ask your health care||
9251|007|Z|professional for complete information about this product and your||
9251|008|Z|specific health needs.||
9251|009|B|||
9251|010|T|OLMESARTAN/HYDROCHLOROTHIAZIDE - ORAL||
9251|011|F|(OL-me-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)||
9251|012|B|||
9251|013|C|COMMON BRAND NAME(S): Benicar HCT||
9251|014|B|||
9251|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
9251|016|W|unborn baby if used during pregnancy. It is important to prevent||
9251|017|W|pregnancy while taking this medication. Consult your doctor for||
9251|018|W|more details and to discuss the use of reliable forms of birth||
9251|019|W|control while taking this medication. If you are planning||
9251|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
9251|021|W|your doctor right away.||
9251|022|B|||
9251|023|U|USES:  This drug is used to treat high blood pressure||
9251|024|U|(hypertension). Lowering high blood pressure helps prevent||
9251|025|U|strokes, heart attacks, and kidney problems. This product||
9251|026|U|contains two medications: olmesartan and hydrochlorothiazide.||
9251|027|U|Olmesartan is an angiotensin receptor blocker (ARB) and works by||
9251|028|U|relaxing blood vessels so that blood can flow more easily.||
9251|029|U|Hydrochlorothiazide is a "water pill" (diuretic) that causes you||
9251|030|U|to make more urine, which helps your body get rid of extra salt||
9251|031|U|and water.||
9251|032|B|||
9251|033|V|OTHER USES:  This section contains uses of this drug that are not||
9251|034|V|listed in the approved professional labeling for the drug but||
9251|035|V|that may be prescribed by your health care professional. Use this||
9251|036|V|drug for a condition that is listed in this section only if it||
9251|037|V|has been so prescribed by your health care professional.||
9251|038|V|   This drug may also be used for heart failure.||
9251|039|B|||
9251|040|H|HOW TO USE:  Take this medication by mouth with or without food||
9251|041|H|as directed by your doctor, usually once daily. If this||
9251|042|H|medication causes you to urinate more often, it is best to take||
9251|043|H|it at least 4 hours before your bedtime to prevent having to get||
9251|044|H|up to urinate.||
9251|045|H|   If you also take certain drugs to lower your cholesterol (bile||
9251|046|H|acid-binding resins such as cholestyramine, colesevelam or||
9251|047|H|colestipol), take this product at least 4 hours before or at||
9251|048|H|least 4 to 6 hours after these medications.||
9251|049|H|   The dosage is based on your medical condition and response to||
9251|050|H|treatment.||
9251|051|H|   Use this medication regularly to get the most benefit from it.||
9251|052|H|To help you remember, take it at the same time each day. Keep||
9251|053|H|taking this medication even if you feel well. Most people with||
9251|054|H|high blood pressure do not feel sick.||
9251|055|H|   Tell your doctor if your condition does not get better or if||
9251|056|H|it gets worse (your blood pressure readings remain high or||
9251|057|H|increase).||
9251|058|B|||
9251|059|S|SIDE EFFECTS:  Dizziness or lightheadedness may occur as your||
9251|060|S|body adjusts to the medication. If any of these effects last or||
9251|061|S|get worse, tell your doctor or pharmacist promptly.||
9251|062|S|   To reduce the risk of dizziness and lightheadedness, get up||
9251|063|S|slowly when rising from a sitting or lying position.||
9251|064|S|   Remember that this medication has been prescribed because your||
9251|065|S|doctor has judged that the benefit to you is greater than the||
9251|066|S|risk of side effects. Many people using this medication do not||
9251|067|S|have serious side effects.||
9251|068|S|   This product may cause dehydration and electrolyte imbalance.||
9251|069|S|Tell your doctor right away if you have any symptoms of||
9251|070|S|dehydration or electrolyte imbalance, including unusual dry||
9251|071|S|mouth/thirst, muscle cramps/weakness, slow/fast/irregular||
9251|072|S|heartbeat, or confusion.||
9251|073|S|   Tell your doctor right away if you have any serious side||
9251|074|S|effects, including: diarrhea that doesn't stop, fainting,||
9251|075|S|decrease in vision, eye pain, signs of kidney problems (such as||
9251|076|S|change in the amount of urine).||
9251|077|S|   A very serious allergic reaction to this drug is rare.||
9251|078|S|However, get medical help right away if you notice any symptoms||
9251|079|S|of a serious allergic reaction, including: rash, itching/swelling||
9251|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9251|081|S|breathing.||
9251|082|S|   This is not a complete list of possible side effects. If you||
9251|083|S|notice other effects not listed above, contact your doctor or||
9251|084|S|pharmacist.||
9251|085|S|   In the US -||
9251|086|S|   Call your doctor for medical advice about side effects. You||
9251|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9251|088|S|www.fda.gov/medwatch.||
9251|089|S|   In Canada - Call your doctor for medical advice about side||
9251|090|S|effects. You may report side effects to Health Canada at||
9251|091|S|1-866-234-2345.||
9251|092|B|||
9251|093|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9251|094|P|pharmacist if you are allergic to olmesartan or||
9251|095|P|hydrochlorothiazide; or if you have any other allergies. This||
9251|096|P|product may contain inactive ingredients, which can cause||
9251|097|P|allergic reactions or other problems. Talk to your pharmacist for||
9251|098|P|more details.||
9251|099|P|   Before using this medication, tell your doctor or pharmacist||
9251|100|P|your medical history, especially of: gout, kidney disease, liver||
9251|101|P|disease, lupus, dehydration, high level of potassium in the||
9251|102|P|blood, skin cancer.||
9251|103|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9251|104|P|can make you more dizzy. Do not drive, use machinery, or do||
9251|105|P|anything that needs alertness until you can do it safely. Limit||
9251|106|P|alcoholic beverages. Talk to your doctor if you are using||
9251|107|P|marijuana (cannabis).||
9251|108|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
9251|109|P|and cause you to feel lightheaded. Tell your doctor if you have||
9251|110|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
9251|111|P|of fluids unless your doctor tells you not to.||
9251|112|P|   If you have diabetes, this product may affect your blood||
9251|113|P|sugar. Check your blood sugar regularly as directed and share the||
9251|114|P|results with your doctor. Your doctor may need to adjust your||
9251|115|P|diabetes medication, exercise program, or diet.||
9251|116|P|   This medication may make you more sensitive to the sun. It may||
9251|117|P|also increase your risk for skin cancer, especially if you take||
9251|118|P|it for a long time. Limit your time in the sun. Avoid tanning||
9251|119|P|booths and sunlamps. Use sunscreen and wear protective clothing||
9251|120|P|when outdoors. Tell your doctor right away if you get sunburned,||
9251|121|P|have skin blisters/redness, or notice new or changed moles/skin||
9251|122|P|lesions.||
9251|123|P|   This product may affect your potassium levels. Before using||
9251|124|P|potassium supplements or salt substitutes that contain potassium,||
9251|125|P|consult your doctor or pharmacist.||
9251|126|P|   Before having surgery, tell your doctor or dentist about all||
9251|127|P|the products you use (including prescription drugs,||
9251|128|P|nonprescription drugs, and herbal products).||
9251|129|P|   Older adults may be more sensitive to the side effects of this||
9251|130|P|drug, especially dizziness and change in the amount of urine||
9251|131|P|(kidney problems).||
9251|132|P|   Tell your doctor if you are pregnant or plan to become||
9251|133|P|pregnant. You should not become pregnant while using this||
9251|134|P|product. Olmesartan may harm an unborn baby. If you become||
9251|135|P|pregnant, talk to your doctor right away about the risks and||
9251|136|P|benefits of this medication. (See also Warning section.)||
9251|137|P|   It is unknown if olmesartan passes into breast milk.||
9251|138|P|Hydrochlorothiazide passes into breast milk, but is unlikely to||
9251|139|P|harm a nursing infant. Consult your doctor before breastfeeding.||
9251|140|B|||
9251|141|I|DRUG INTERACTIONS:  See also How to Use and Precautions sections.||
9251|142|I|   Drug interactions may change how your medications work or||
9251|143|I|increase your risk for serious side effects. This document does||
9251|144|I|not contain all possible drug interactions. Keep a list of all||
9251|145|I|the products you use (including prescription/nonprescription||
9251|146|I|drugs and herbal products) and share it with your doctor and||
9251|147|I|pharmacist. Do not start, stop, or change the dosage of any||
9251|148|I|medicines without your doctor's approval.||
9251|149|I|   Some products that may interact with this drug include:||
9251|150|I|aliskiren, dofetilide, lithium, drugs that may increase the level||
9251|151|I|of potassium in the blood (such as sparsentan, ACE inhibitors||
9251|152|I|including benazepril/lisinopril, birth control pills containing||
9251|153|I|drospirenone).||
9251|154|I|   Some products have ingredients that could raise your blood||
9251|155|I|pressure or worsen your heart failure. Tell your pharmacist what||
9251|156|I|products you are using, and ask how to use them safely||
9251|157|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
9251|158|I|ibuprofen/naproxen).||
9251|159|I|   This medication may interfere with certain lab tests (such as||
9251|160|I|parathyroid function), possibly causing false test results. Make||
9251|161|I|sure lab personnel and all your doctors know you use this drug.||
9251|162|B|||
9251|163|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9251|164|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9251|165|O|poison control center right away. US residents can call||
9251|166|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9251|167|O|Symptoms of overdose may include: severe dizziness, fainting.||
9251|168|B|||
9251|169|N|NOTES:  Do not share this medication with others.||
9251|170|N|   Lifestyle changes such as stress reduction programs, exercise,||
9251|171|N|and dietary changes may increase the effectiveness of this||
9251|172|N|medicine. Talk to your doctor or pharmacist about lifestyle||
9251|173|N|changes that might benefit you.||
9251|174|N|   Lab and/or medical tests (such as kidney function, potassium||
9251|175|N|levels, skin exams, cholesterol levels) should be done while you||
9251|176|N|are taking this medication. Keep all medical and lab||
9251|177|N|appointments. Consult your doctor for more details.||
9251|178|N|   Check your blood pressure regularly while taking this||
9251|179|N|medication. Learn how to monitor your own blood pressure, and||
9251|180|N|share the results with your doctor.||
9251|181|B|||
9251|182|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9251|183|D|remember. If it is near the time of the next dose, skip the||
9251|184|D|missed dose. Take your next dose at the regular time. Do not||
9251|185|D|double the dose to catch up.||
9251|186|B|||
9251|187|R|STORAGE:  Store at room temperature away from light and moisture.||
9251|188|R|Do not store in the bathroom. Keep all medications away from||
9251|189|R|children and pets.||
9251|190|R|   Do not flush medications down the toilet or pour them into a||
9251|191|R|drain unless instructed to do so. Properly discard this product||
9251|192|R|when it is expired or no longer needed. Consult your pharmacist||
9251|193|R|or local waste disposal company.||
9251|194|B|||
9251|195|A|Information last revised March 2025.||
9251|196|A|Copyright(c) 2025 First Databank, Inc.||
9251|197|B|||
9252|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9252|002|Z|does NOT have all possible information about this product. This||
9252|003|Z|information does not assure that this product is safe, effective,||
9252|004|Z|or appropriate for you. This information is not individual||
9252|005|Z|medical advice and does not substitute for the advice of your||
9252|006|Z|health care professional. Always ask your health care||
9252|007|Z|professional for complete information about this product and your||
9252|008|Z|specific health needs.||
9252|009|B|||
9252|010|T|LIDOCAINE SPRAY - MUCOUS MEMBRANE||
9252|011|F|(LYE-doe-kane)||
9252|012|B|||
9252|013|C|COMMON BRAND NAME(S): Xylocaine||
9252|014|B|||
9252|015|U|USES:  Lidocaine spray is used to numb the lining of the mouth,||
9252|016|U|throat, or nose before certain medical/dental procedures. It also||
9252|017|U|helps prevent the urge to close the throat (gag reflex), which||
9252|018|U|might make the procedure more difficult. Lidocaine belongs to a||
9252|019|U|class of drugs known as local anesthetics.||
9252|020|B|||
9252|021|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9252|022|H|from your pharmacist before you start using lidocaine and each||
9252|023|H|time you get a refill. If you have any questions, ask your doctor||
9252|024|H|or pharmacist.||
9252|025|H|   This medication is usually sprayed in the mouth by a health||
9252|026|H|care professional as directed by your doctor right before your||
9252|027|H|procedure.||
9252|028|H|   The dosage is based on your medical condition and response to||
9252|029|H|treatment. Children's dosage is also based on age and weight.||
9252|030|H|   Numbness may make swallowing difficult and increase your risk||
9252|031|H|of swallowing the wrong way or choking. Do not chew gum or eat||
9252|032|H|for 1 hour after using this product and while your mouth or||
9252|033|H|throat is numb. It is especially important for children to not||
9252|034|H|eat or chew gum for at least 1 hour after their procedures. Be||
9252|035|H|careful not to accidentally bite your tongue or mouth.||
9252|036|H|   Lidocaine starts to numb the affected area within 5 minutes||
9252|037|H|after application. Tell your doctor if the area does not feel||
9252|038|H|numb or the numbness does not go away.||
9252|039|B|||
9252|040|S|SIDE EFFECTS:  Mild nausea, stinging, swelling, or burning may||
9252|041|S|occur. If any of these effects last or get worse, tell your||
9252|042|S|doctor or pharmacist promptly.||
9252|043|S|   Remember that this medication has been prescribed because your||
9252|044|S|doctor has judged that the benefit to you is greater than the||
9252|045|S|risk of side effects. Many people using this medication do not||
9252|046|S|have serious side effects.||
9252|047|S|   This medication may cause very serious side effects if you are||
9252|048|S|using too much of it or are very sensitive to its effects. Stop||
9252|049|S|using this medication and get medical help right away if you have||
9252|050|S|any very serious side effects, including: dizziness, drowsiness,||
9252|051|S|slow/shallow breathing, mental/mood changes (such as confusion,||
9252|052|S|nervousness), shaking, seizures, vision changes (such as||
9252|053|S|double/blurred vision), ringing in the ears, fainting,||
9252|054|S|pale/bluish/gray skin, unusual tiredness, shortness of breath,||
9252|055|S|fast/slow/irregular heartbeat.||
9252|056|S|   A very serious allergic reaction to this drug is rare.||
9252|057|S|However, get medical help right away if you notice any symptoms||
9252|058|S|of a serious allergic reaction, including: rash, itching/swelling||
9252|059|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9252|060|S|breathing.||
9252|061|S|   This is not a complete list of possible side effects. If you||
9252|062|S|notice other effects not listed above, contact your doctor or||
9252|063|S|pharmacist.||
9252|064|S|   In the US -||
9252|065|S|   Call your doctor for medical advice about side effects. You||
9252|066|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9252|067|S|www.fda.gov/medwatch.||
9252|068|S|   In Canada - Call your doctor for medical advice about side||
9252|069|S|effects. You may report side effects to Health Canada at||
9252|070|S|1-866-234-2345.||
9252|071|B|||
9252|072|P|PRECAUTIONS:  Before using lidocaine, tell your doctor or||
9252|073|P|pharmacist if you are allergic to it; or to other anesthetics||
9252|074|P|(such as bupivacaine, prilocaine); or to PABA; or if you have any||
9252|075|P|other allergies. This product may contain inactive ingredients,||
9252|076|P|which can cause allergic reactions or other problems. Talk to||
9252|077|P|your pharmacist for more details.||
9252|078|P|   Before using this medication, tell your doctor or pharmacist||
9252|079|P|your medical history, especially of: cuts/sores/bleeding in the||
9252|080|P|area to be applied, heart problems (such as slow/irregular||
9252|081|P|heartbeat, heart block), kidney disease, liver disease, a certain||
9252|082|P|blood disorder (methemoglobinemia).||
9252|083|P|   This drug may make you dizzy or drowsy or cause vision||
9252|084|P|problems if you are using too much of it or are very sensitive to||
9252|085|P|its effects. See Side Effects section. Alcohol or marijuana||
9252|086|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9252|087|P|machinery, or do anything that needs alertness or clear vision||
9252|088|P|until you can do it safely. Limit alcoholic beverages. Talk to||
9252|089|P|your doctor if you are using marijuana (cannabis).||
9252|090|P|   Before having surgery, tell your doctor or dentist about all||
9252|091|P|the products you use (including prescription drugs,||
9252|092|P|nonprescription drugs, and herbal products).||
9252|093|P|   Children may be more sensitive to the side effects of this||
9252|094|P|drug, especially dizziness and drowsiness.||
9252|095|P|   During pregnancy, this medication should be used only when||
9252|096|P|clearly needed. Discuss the risks and benefits with your doctor.||
9252|097|P|   This medication passes into breast milk, but is unlikely to||
9252|098|P|harm a nursing infant. Consult your doctor before breastfeeding.||
9252|099|B|||
9252|100|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9252|101|I|medications work or increase your risk for serious side effects.||
9252|102|I|This document does not contain all possible drug interactions.||
9252|103|I|Keep a list of all the products you use (including||
9252|104|I|prescription/nonprescription drugs and herbal products) and share||
9252|105|I|it with your doctor and pharmacist. Do not start, stop, or change||
9252|106|I|the dosage of any medicines without your doctor's approval.||
9252|107|I|   Tell your doctor or pharmacist if you are using other||
9252|108|I|lidocaine products at the same time as this medication because||
9252|109|I|your risk of serious side effects may increase.||
9252|110|B|||
9252|111|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9252|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9252|113|O|poison control center right away. US residents can call||
9252|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9252|115|O|Symptoms of overdose may include: vision/hearing changes, severe||
9252|116|O|dizziness/drowsiness, fainting, loss of consciousness, shaking,||
9252|117|O|seizures, slow/irregular heartbeat, slow/shallow breathing.||
9252|118|B|||
9252|119|N|NOTES:  Do not share this medication with others.||
9252|120|B|||
9252|121|D|MISSED DOSE:  Not applicable.||
9252|122|B|||
9252|123|R|STORAGE:  Store at room temperature away from light. Do not||
9252|124|R|freeze. Keep all medications away from children and pets.||
9252|125|R|   Do not flush medications down the toilet or pour them into a||
9252|126|R|drain unless instructed to do so. Properly discard this product||
9252|127|R|when it is expired or no longer needed. Consult your pharmacist||
9252|128|R|or local waste disposal company.||
9252|129|B|||
9252|130|A|Information last revised January 2025.||
9252|131|A|Copyright(c) 2025 First Databank, Inc.||
9252|132|B|||
9253|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9253|002|Z|does NOT have all possible information about this product. This||
9253|003|Z|information does not assure that this product is safe, effective,||
9253|004|Z|or appropriate for you. This information is not individual||
9253|005|Z|medical advice and does not substitute for the advice of your||
9253|006|Z|health care professional. Always ask your health care||
9253|007|Z|professional for complete information about this product and your||
9253|008|Z|specific health needs.||
9253|009|B|||
9253|010|T|HYDROCORTISONE/BENZOYL PEROXIDE - TOPICAL||
9253|011|F|(HYE-droe-KOR-ti-sone/BEN-zoh-ill per-OX-ide)||
9253|012|B|||
9253|013|C|COMMON BRAND NAME(S): Vanoxide-HC||
9253|014|B|||
9253|015|U|USES:  This product is used to treat acne and oily skin. The||
9253|016|U|product contains two ingredients, hydrocortisone and benzoyl||
9253|017|U|peroxide. Hydrocortisone is a corticosteroid that acts to||
9253|018|U|decrease the skin swelling that can occur with acne. Benzoyl||
9253|019|U|peroxide works by reducing the amount of acne-causing bacteria.||
9253|020|U|It also helps to heal pimples by causing the skin to dry and||
9253|021|U|peel.||
9253|022|B|||
9253|023|H|HOW TO USE:  Shake the container well before each use. Wash your||
9253|024|H|hands before and after using this medication. Apply this||
9253|025|H|medication to the areas of your skin affected by acne as directed||
9253|026|H|by your doctor, usually 1 to 3 times a day. Before applying each||
9253|027|H|dose, gently wash the affected area with a mild cleanser, and||
9253|028|H|then pat dry. Apply a small amount of medicine to the affected||
9253|029|H|area and rub in gently.||
9253|030|H|   Do not bandage, cover, or wrap the area unless directed to do||
9253|031|H|so by your doctor.||
9253|032|H|   The dosage is based on your medical condition and response to||
9253|033|H|treatment. Your acne may become worse before it improves. It may||
9253|034|H|take 3 weeks of use to notice improvement in acne. It may take 8||
9253|035|H|to 12 weeks before full benefit takes effect.||
9253|036|H|   Do not use large amounts of this medication or apply it more||
9253|037|H|often than directed. Doing so will not clear acne faster and may||
9253|038|H|increase side effects.||
9253|039|H|   Avoid getting this medication into your eyes, inside your nose||
9253|040|H|or mouth, or on any areas of broken skin since it may cause||
9253|041|H|irritation. If this occurs, flush the area with plenty of water.||
9253|042|H|Benzoyl peroxide may bleach hair or fabrics. Use carefully, and||
9253|043|H|avoid contact with hair, clothing, and furnishings.||
9253|044|H|   Use this medication regularly in order to get the most benefit||
9253|045|H|from it. To help you remember, use it at the same time(s) each||
9253|046|H|day.||
9253|047|H|   Tell your doctor if your condition lasts or gets worse.||
9253|048|B|||
9253|049|S|SIDE EFFECTS:  Skin reactions such as peeling, itching,||
9253|050|S|irritation, and redness may occur, especially at the start of||
9253|051|S|treatment. You may need to apply smaller amounts of the drug or||
9253|052|S|use it less often. Consult your doctor or pharmacist for more||
9253|053|S|details. Less common side effects include skin||
9253|054|S|thinning/discoloration, small red bumps on the skin||
9253|055|S|(folliculitis), or stretch marks. If any of these effects last or||
9253|056|S|get worse, tell your doctor or pharmacist promptly.||
9253|057|S|   Remember that this medication has been prescribed because your||
9253|058|S|doctor has judged that the benefit to you is greater than the||
9253|059|S|risk of side effects. Many people using this medication do not||
9253|060|S|have serious side effects.||
9253|061|S|   A very serious allergic reaction to this drug is rare.||
9253|062|S|However, get medical help right away if you notice any symptoms||
9253|063|S|of a serious allergic reaction, including: rash, itching/swelling||
9253|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9253|065|S|breathing.||
9253|066|S|   This is not a complete list of possible side effects. If you||
9253|067|S|notice other effects not listed above, contact your doctor or||
9253|068|S|pharmacist.||
9253|069|S|   In the US -||
9253|070|S|   Call your doctor for medical advice about side effects. You||
9253|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9253|072|S|www.fda.gov/medwatch.||
9253|073|S|   In Canada - Call your doctor for medical advice about side||
9253|074|S|effects. You may report side effects to Health Canada at||
9253|075|S|1-866-234-2345.||
9253|076|B|||
9253|077|P|PRECAUTIONS:  Before using this product, tell your doctor or||
9253|078|P|pharmacist if you are allergic to benzoyl peroxide or||
9253|079|P|hydrocortisone; or to other corticosteroids (such as prednisone,||
9253|080|P|triamcinolone); or if you have any other allergies. This product||
9253|081|P|may contain inactive ingredients (such as paraben preservatives),||
9253|082|P|which can cause allergic reactions or other problems. Talk to||
9253|083|P|your pharmacist for more details.||
9253|084|P|   Before using this medication, tell your doctor or pharmacist||
9253|085|P|your medical history, especially of: skin infections (especially||
9253|086|P|viral infections like varicella).||
9253|087|P|   Do not use this medication in an area where there is an||
9253|088|P|infection or sore. If you apply the medication to an infected||
9253|089|P|area, the infection may become worse. Tell your doctor promptly||
9253|090|P|if redness, swelling, or irritation does not improve.||
9253|091|P|   Children may be more sensitive to the effects of too much||
9253|092|P|corticosteroid medication. Consult your doctor for more details.||
9253|093|P|   During pregnancy, this medication should be used only when||
9253|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
9253|095|P|   It is unknown if this drug passes into breast milk. Consult||
9253|096|P|your doctor before breastfeeding.||
9253|097|B|||
9253|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9253|099|I|medications work or increase your risk for serious side effects.||
9253|100|I|This document does not contain all possible drug interactions.||
9253|101|I|Keep a list of all the products you use (including||
9253|102|I|prescription/nonprescription drugs and herbal products) and share||
9253|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
9253|104|I|the dosage of any medicines without your doctor's approval.||
9253|105|I|   A product that may interact with this drug is: dapsone used on||
9253|106|I|the skin.||
9253|107|B|||
9253|108|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9253|109|O|has overdosed and has serious symptoms such as passing out or||
9253|110|O|trouble breathing, call 911. Otherwise, call a poison control||
9253|111|O|center right away. US residents can call 1-800-222-1222. Canada||
9253|112|O|residents can call 1-844-764-7669.||
9253|113|B|||
9253|114|N|NOTES:  Apply this medication cautiously and wash hands after||
9253|115|N|use. This medication may bleach or stain hair or colored||
9253|116|N|clothing/fabrics.||
9253|117|N|   Tell all your doctors you use (or have used) this medication.||
9253|118|N|   Do not share this medication with others.||
9253|119|B|||
9253|120|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9253|121|D|If it is near the time of the next dose, skip the missed dose.||
9253|122|D|Use your next dose at the regular time. Do not double the dose to||
9253|123|D|catch up.||
9253|124|B|||
9253|125|R|STORAGE:  Store at room temperature. Do not freeze. Keep all||
9253|126|R|medications away from children and pets.||
9253|127|R|   Do not flush medications down the toilet or pour them into a||
9253|128|R|drain unless instructed to do so. Properly discard this product||
9253|129|R|when it is expired or no longer needed. Consult your pharmacist||
9253|130|R|or local waste disposal company.||
9253|131|B|||
9253|132|A|Information last revised May 2024.||
9253|133|A|Copyright(c) 2025 First Databank, Inc.||
9253|134|B|||
9254|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9254|002|Z|does NOT have all possible information about this product. This||
9254|003|Z|information does not assure that this product is safe, effective,||
9254|004|Z|or appropriate for you. This information is not individual||
9254|005|Z|medical advice and does not substitute for the advice of your||
9254|006|Z|health care professional. Always ask your health care||
9254|007|Z|professional for complete information about this product and your||
9254|008|Z|specific health needs.||
9254|009|B|||
9254|010|T|PAROMOMYCIN - ORAL||
9254|011|F|(PAIR-oh-mow-MY-sin)||
9254|012|B|||
9254|013|C|COMMON BRAND NAME(S): Humatin||
9254|014|B|||
9254|015|U|USES:  This medication is used to treat a certain parasite||
9254|016|U|infection of the intestines (amebiasis). This medication is known||
9254|017|U|as an aminoglycoside antibiotic. It works by stopping the growth||
9254|018|U|of parasites in the intestines. This medication is poorly||
9254|019|U|absorbed into the blood so it will not work for infections||
9254|020|U|outside of the intestines.||
9254|021|U|   Paromomycin may also be used along with a special diet to||
9254|022|U|treat a certain serious brain problem (hepatic encephalopathy).||
9254|023|U|This condition occurs in people with liver disease and is caused||
9254|024|U|by too much of a certain natural substance (ammonia) in the body.||
9254|025|U|Normally the liver gets rid of the ammonia. Paromomycin helps to||
9254|026|U|treat hepatic encephalopathy by stopping the growth of certain||
9254|027|U|bacteria in your intestines that make ammonia.||
9254|028|U|   This antibiotic treats only parasitic and bacterial||
9254|029|U|infections. It will not work for viral infections (such as common||
9254|030|U|cold, flu). Unnecessary use or misuse of any antibiotic can lead||
9254|031|U|to its decreased effectiveness.||
9254|032|B|||
9254|033|V|OTHER USES:  This section contains uses of this drug that are not||
9254|034|V|listed in the approved professional labeling for the drug but||
9254|035|V|that may be prescribed by your health care professional. Use this||
9254|036|V|drug for a condition that is listed in this section only if it||
9254|037|V|has been so prescribed by your health care professional.||
9254|038|V|   This drug may also be used for other intestinal infections||
9254|039|V|(such as tapeworm infections, giardiasis).||
9254|040|B|||
9254|041|H|HOW TO USE:  Take this medication by mouth with meals as directed||
9254|042|H|by your doctor, usually 3 times daily (every 8 hours).||
9254|043|H|   The dosage is based on your weight, medical condition, and||
9254|044|H|response to treatment.||
9254|045|H|   For the best effect, take this antibiotic at evenly spaced||
9254|046|H|times. To help you remember, take this medication at the same||
9254|047|H|time(s) every day.||
9254|048|H|   Continue to take this medication until the full prescribed||
9254|049|H|amount is finished, even if symptoms disappear after a few days.||
9254|050|H|Stopping the medication too early may result in a return of the||
9254|051|H|infection.||
9254|052|H|   Tell your doctor if your condition lasts or gets worse.||
9254|053|B|||
9254|054|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, abdominal||
9254|055|S|cramps, diarrhea, and heartburn may occur. If any of these||
9254|056|S|effects last or get worse, tell your doctor or pharmacist||
9254|057|S|promptly.||
9254|058|S|   Remember that this medication has been prescribed because your||
9254|059|S|doctor has judged that the benefit to you is greater than the||
9254|060|S|risk of side effects. Many people using this medication do not||
9254|061|S|have serious side effects.||
9254|062|S|   Tell your doctor right away if you have any serious side||
9254|063|S|effects, including: oily stools, ringing/roaring sounds in the||
9254|064|S|ears, hearing loss, dizziness, numb/tingling skin, headache,||
9254|065|S|seizures, muscle weakness.||
9254|066|S|   Use of this medication for prolonged or repeated periods may||
9254|067|S|result in oral thrush or a new vaginal yeast infection. Contact||
9254|068|S|your doctor if you notice white patches in your mouth, a change||
9254|069|S|in vaginal discharge, or other new symptoms.||
9254|070|S|   A very serious allergic reaction to this drug is rare.||
9254|071|S|However, get medical help right away if you notice any symptoms||
9254|072|S|of a serious allergic reaction, including: rash, itching/swelling||
9254|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9254|074|S|breathing.||
9254|075|S|   This is not a complete list of possible side effects. If you||
9254|076|S|notice other effects not listed above, contact your doctor or||
9254|077|S|pharmacist.||
9254|078|S|   In the US -||
9254|079|S|   Call your doctor for medical advice about side effects. You||
9254|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9254|081|S|www.fda.gov/medwatch.||
9254|082|S|   In Canada - Call your doctor for medical advice about side||
9254|083|S|effects. You may report side effects to Health Canada at||
9254|084|S|1-866-234-2345.||
9254|085|B|||
9254|086|P|PRECAUTIONS:  Before taking paromomycin, tell your doctor or||
9254|087|P|pharmacist if you are allergic to it; or to other aminoglycoside||
9254|088|P|antibiotics (such as gentamicin, tobramycin); or if you have any||
9254|089|P|other allergies. This product may contain inactive ingredients,||
9254|090|P|which can cause allergic reactions or other problems. Talk to||
9254|091|P|your pharmacist for more details.||
9254|092|P|   Before using this medication, tell your doctor or pharmacist||
9254|093|P|your medical history, especially of: intestinal problems (such as||
9254|094|P|blockage, ulcers).||
9254|095|P|   Paromomycin may cause live bacterial vaccines (such as typhoid||
9254|096|P|vaccine) to not work well. Tell your health care professional||
9254|097|P|that you are using paromomycin before having any||
9254|098|P|immunizations/vaccinations.||
9254|099|P|   Before having surgery, tell your doctor or dentist about all||
9254|100|P|the products you use (including prescription drugs,||
9254|101|P|nonprescription drugs, and herbal products).||
9254|102|P|   During pregnancy, this medication should be used only when||
9254|103|P|clearly needed. Discuss the risks and benefits with your doctor.||
9254|104|P|   It is unknown if this medication passes into breast milk.||
9254|105|P|Consult your doctor before breastfeeding.||
9254|106|B|||
9254|107|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9254|108|I|medications work or increase your risk for serious side effects.||
9254|109|I|This document does not contain all possible drug interactions.||
9254|110|I|Keep a list of all the products you use (including||
9254|111|I|prescription/nonprescription drugs and herbal products) and share||
9254|112|I|it with your doctor and pharmacist. Do not start, stop, or change||
9254|113|I|the dosage of any medicines without your doctor's approval.||
9254|114|B|||
9254|115|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9254|116|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9254|117|O|poison control center right away. US residents can call||
9254|118|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9254|119|B|||
9254|120|N|NOTES:  Do not share this medication with others.||
9254|121|N|   This medication has been prescribed for your current condition||
9254|122|N|only. Do not use it later for another infection unless your||
9254|123|N|doctor tells you to.||
9254|124|B|||
9254|125|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9254|126|D|remember. If it is near the time of the next dose, skip the||
9254|127|D|missed dose. Take your next dose at the regular time. Do not||
9254|128|D|double the dose to catch up.||
9254|129|B|||
9254|130|R|STORAGE:  Store at room temperature away from light and moisture.||
9254|131|R|Do not store in the bathroom. Keep all medications away from||
9254|132|R|children and pets.||
9254|133|R|   Do not flush medications down the toilet or pour them into a||
9254|134|R|drain unless instructed to do so. Properly discard this product||
9254|135|R|when it is expired or no longer needed. Consult your pharmacist||
9254|136|R|or local waste disposal company.||
9254|137|B|||
9254|138|A|Information last revised May 2024.||
9254|139|A|Copyright(c) 2025 First Databank, Inc.||
9254|140|B|||
9259|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9259|002|Z|does NOT have all possible information about this product. This||
9259|003|Z|information does not assure that this product is safe, effective,||
9259|004|Z|or appropriate for you. This information is not individual||
9259|005|Z|medical advice and does not substitute for the advice of your||
9259|006|Z|health care professional. Always ask your health care||
9259|007|Z|professional for complete information about this product and your||
9259|008|Z|specific health needs.||
9259|009|B|||
9259|010|T|PHENYLEPHRINE HEMORRHOIDAL OINTMENT - RECTAL||
9259|011|F|(FEN-il-EF-rin)||
9259|012|B|||
9259|013|C|COMMON BRAND NAME(S): Formulation R, Hemorrhoidal, Preparation H||
9259|014|B|||
9259|015|U|USES:  This medication is used to temporarily relieve swelling,||
9259|016|U|burning, pain, and itching caused by hemorrhoids. It contains||
9259|017|U|phenylephrine, which belongs to a class of drugs known as||
9259|018|U|sympathomimetic amines. It works by temporarily narrowing the||
9259|019|U|blood vessels in the area. This effect decreases swelling and||
9259|020|U|discomfort.||
9259|021|U|   Some products may also contain substances (such as cocoa||
9259|022|U|butter, hard fat, mineral oil, shark liver oil) that form a||
9259|023|U|protective barrier to prevent too much irritating contact with||
9259|024|U|stool.||
9259|025|U|   Do not use this product in children 12 years or younger||
9259|026|U|without talking with the doctor.||
9259|027|B|||
9259|028|H|HOW TO USE:  Follow all directions on the product package. If you||
9259|029|H|have any questions, ask your doctor or pharmacist.||
9259|030|H|   Use this product up to 4 times daily, usually in the morning||
9259|031|H|and bedtime, or after each bowel movement or as directed by your||
9259|032|H|doctor||
9259|033|H|   Before use, clean the area with mild soap and water, rinse||
9259|034|H|well, and pat dry.||
9259|035|H|   Remove the protective cover from the applicator tip, attach||
9259|036|H|the applicator tip to the medication tube, and place a small||
9259|037|H|amount of ointment on the applicator tip. Gently insert the||
9259|038|H|applicator tip into the rectum and squeeze the tube to apply a||
9259|039|H|small amount of this medication. Also apply some medication to||
9259|040|H|the outside of the anus.||
9259|041|H|   After each use, clean the applicator tip well and replace the||
9259|042|H|protective cover.||
9259|043|H|   The dosage is based on your medical condition and response to||
9259|044|H|treatment. Do not use more often or for a longer time than||
9259|045|H|recommended.||
9259|046|H|   Tell your doctor if your symptoms do not get better within 7||
9259|047|H|days or if bleeding/worsening pain occurs. If you think you may||
9259|048|H|have a serious medical problem, get medical help right away.||
9259|049|B|||
9259|050|S|SIDE EFFECTS:  This medication does not usually have bothersome||
9259|051|S|side effects when used as directed. Mild pain/stinging may occur||
9259|052|S|if the rectal tissue is raw or bleeding. If any of these effects||
9259|053|S|last or get worse, tell your doctor or pharmacist promptly.||
9259|054|S|   If your doctor has directed you to use this medication,||
9259|055|S|remember that your doctor has judged that the benefit to you is||
9259|056|S|greater than the risk of side effects. Many people using this||
9259|057|S|medication do not have serious side effects.||
9259|058|S|   Stop using this medication and tell your doctor right away if||
9259|059|S|you have any serious side effects, including: fast/irregular||
9259|060|S|heartbeat, pounding headache, nervousness, shakiness (tremor),||
9259|061|S|trouble sleeping.||
9259|062|S|   A very serious allergic reaction to this drug is rare.||
9259|063|S|However, get medical help right away if you notice any symptoms||
9259|064|S|of a serious allergic reaction, including: rash, itching/swelling||
9259|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9259|066|S|breathing.||
9259|067|S|   This is not a complete list of possible side effects. If you||
9259|068|S|notice other effects not listed above, contact your doctor or||
9259|069|S|pharmacist.||
9259|070|S|   In the US -||
9259|071|S|   Call your doctor for medical advice about side effects. You||
9259|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9259|073|S|www.fda.gov/medwatch.||
9259|074|S|   In Canada - Call your doctor for medical advice about side||
9259|075|S|effects. You may report side effects to Health Canada at||
9259|076|S|1-866-234-2345.||
9259|077|B|||
9259|078|P|PRECAUTIONS:  Before using this product, tell your doctor or||
9259|079|P|pharmacist if you are allergic to it; or to any of its||
9259|080|P|ingredients; or if you have any other allergies. This product may||
9259|081|P|contain inactive ingredients, which can cause allergic reactions||
9259|082|P|or other problems. Talk to your pharmacist for more details.||
9259|083|P|   If you have any of the following health problems, consult your||
9259|084|P|doctor or pharmacist before using this product: diabetes, heart||
9259|085|P|problems (such as chest pain, heart attack), high blood pressure,||
9259|086|P|overactive thyroid (hyperthyroidism), difficult urination due to||
9259|087|P|blockage (for example, due to an enlarged prostate).||
9259|088|P|   Before having surgery, tell your doctor or dentist about all||
9259|089|P|the products you use (including prescription drugs,||
9259|090|P|nonprescription drugs, and herbal products).||
9259|091|P|   During pregnancy, this medication should be used only when||
9259|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
9259|093|P|   It is unknown if this drug passes into breast milk. Consult||
9259|094|P|your doctor before breastfeeding.||
9259|095|B|||
9259|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9259|097|I|medications work or increase your risk for serious side effects.||
9259|098|I|This document does not contain all possible drug interactions.||
9259|099|I|Keep a list of all the products you use (including||
9259|100|I|prescription/nonprescription drugs and herbal products) and share||
9259|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
9259|102|I|the dosage of any medicines without your doctor's approval.||
9259|103|B|||
9259|104|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9259|105|O|has overdosed and has serious symptoms such as passing out or||
9259|106|O|trouble breathing, call 911. Otherwise, call a poison control||
9259|107|O|center right away. US residents can call 1-800-222-1222. Canada||
9259|108|O|residents can call 1-844-764-7669.||
9259|109|B|||
9259|110|N|NOTES:  To maintain normal bowel function and reduce the risk of||
9259|111|N|hemorrhoids, eat a proper diet high in fiber, drink 6 to 8||
9259|112|N|glasses of water each day, and exercise regularly.||
9259|113|B|||
9259|114|D|MISSED DOSE:  If you are using this product on a regular schedule||
9259|115|D|and miss a dose, use it as soon as you remember. If it is near||
9259|116|D|the time of the next dose, skip the missed dose. Use your next||
9259|117|D|dose at the regular time. Do not double the dose to catch up.||
9259|118|B|||
9259|119|R|STORAGE:  Store at room temperature. Different brands of this||
9259|120|R|medication may have different storage needs. Check the product||
9259|121|R|package for instructions on how to store your brand, or ask your||
9259|122|R|pharmacist. Keep all medications away from children and pets.||
9259|123|R|   Do not flush medications down the toilet or pour them into a||
9259|124|R|drain unless instructed to do so. Properly discard this product||
9259|125|R|when it is expired or no longer needed. Consult your pharmacist||
9259|126|R|or local waste disposal company.||
9259|127|B|||
9259|128|A|Information last revised June 2025.||
9259|129|A|Copyright(c) 2025 First Databank, Inc.||
9259|130|B|||
9262|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9262|002|Z|does NOT have all possible information about this product. This||
9262|003|Z|information does not assure that this product is safe, effective,||
9262|004|Z|or appropriate for you. This information is not individual||
9262|005|Z|medical advice and does not substitute for the advice of your||
9262|006|Z|health care professional. Always ask your health care||
9262|007|Z|professional for complete information about this product and your||
9262|008|Z|specific health needs.||
9262|009|B|||
9262|010|T|AMPHOTERICIN/LIPID COMPLEX - INJECTION||
9262|011|F|(AM-foe-TER-i-sin/LIP-id)||
9262|012|B|||
9262|013|C|COMMON BRAND NAME(S): Abelcet, Ambisome, Amphotec||
9262|014|B|||
9262|015|U|USES:  This medication is used to treat a variety of serious||
9262|016|U|fungal infections. It is often used in patients who cannot||
9262|017|U|tolerate or who do not respond to the regular amphotericin||
9262|018|U|treatment. It works by stopping the growth of fungi.||
9262|019|B|||
9262|020|H|HOW TO USE:  This medication is usually given by injection into a||
9262|021|H|vein as directed by your doctor, usually once a day. It should be||
9262|022|H|injected slowly over 2 hours. The dosage is based on your medical||
9262|023|H|condition, weight, and response to treatment.||
9262|024|H|   If you are giving this medication to yourself at home, learn||
9262|025|H|all preparation and usage instructions from your health care||
9262|026|H|professional. Before using, check this product for particles or||
9262|027|H|discoloration. If either is present, do not use the liquid. Learn||
9262|028|H|how to store and discard medical supplies safely.||
9262|029|H|   Infusion reactions may happen during the infusion of this||
9262|030|H|drug. Your doctor may prescribe other medications (including||
9262|031|H|acetaminophen, diphenhydramine, corticosteroids such as||
9262|032|H|hydrocortisone) before each treatment to help prevent these side||
9262|033|H|effects. Tell your doctor right away if you have any symptoms of||
9262|034|H|infusion reactions such as fever, shaking, chills, flushing, loss||
9262|035|H|of appetite, dizziness, nausea, vomiting, headache, shortness of||
9262|036|H|breath, or fast breathing. Your doctor may give you other||
9262|037|H|medications to help with these side effects.||
9262|038|H|   It may be necessary to continue this medication for several||
9262|039|H|weeks to several months in order to treat certain infections.||
9262|040|H|Stopping the medication too early may result in a return of the||
9262|041|H|infection.||
9262|042|H|   Tell your doctor if your condition lasts or gets worse.||
9262|043|B|||
9262|044|S|SIDE EFFECTS:  See also How to Use section.||
9262|045|S|   Remember that this medication has been prescribed because your||
9262|046|S|doctor has judged that the benefit to you is greater than the||
9262|047|S|risk of side effects. Many people using this medication do not||
9262|048|S|have serious side effects.||
9262|049|S|   Tell your doctor right away if you have any serious side||
9262|050|S|effects, including: swelling/pain at injection site, muscle/joint||
9262|051|S|pain, unusual tiredness, weakness, muscle cramping, signs of||
9262|052|S|kidney problems (such as change in the amount of urine, painful||
9262|053|S|urination), numbness/tingling of arms/legs, vision changes,||
9262|054|S|hearing changes (such as ringing in the ears), signs of liver||
9262|055|S|problems (such as dark urine, stomach/abdominal pain, yellowing||
9262|056|S|eyes/skin), swelling ankles/feet, fast/slow/irregular heartbeat,||
9262|057|S|cold sweats, blue lips, easy bruising/bleeding, other signs of||
9262|058|S|infection (such as sore throat that doesn't go away, fever,||
9262|059|S|chills), mental/mood changes, seizures, black stools, vomit that||
9262|060|S|looks like coffee grounds.||
9262|061|S|   A very serious allergic reaction to this drug is rare.||
9262|062|S|However, get medical help right away if you notice any symptoms||
9262|063|S|of a serious allergic reaction, including: rash, itching/swelling||
9262|064|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9262|065|S|breathing.||
9262|066|S|   This is not a complete list of possible side effects. If you||
9262|067|S|notice other effects not listed above, contact your doctor or||
9262|068|S|pharmacist.||
9262|069|S|   In the US -||
9262|070|S|   Call your doctor for medical advice about side effects. You||
9262|071|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9262|072|S|www.fda.gov/medwatch.||
9262|073|S|   In Canada - Call your doctor for medical advice about side||
9262|074|S|effects. You may report side effects to Health Canada at||
9262|075|S|1-866-234-2345.||
9262|076|B|||
9262|077|P|PRECAUTIONS:  Before using amphotericin/lipid complex, tell your||
9262|078|P|doctor or pharmacist if you are allergic to it; or if you have||
9262|079|P|any other allergies. This product may contain inactive||
9262|080|P|ingredients, which can cause allergic reactions or other||
9262|081|P|problems. Talk to your pharmacist for more details.||
9262|082|P|   Before using this medication, tell your doctor or pharmacist||
9262|083|P|your medical history, especially of: white blood cell (leukocyte)||
9262|084|P|transfusions, heart disease (such as irregular heartbeat, heart||
9262|085|P|failure), liver disease, kidney disease.||
9262|086|P|   Before having surgery, tell your doctor or dentist about all||
9262|087|P|the products you use (including prescription drugs,||
9262|088|P|nonprescription drugs, and herbal products).||
9262|089|P|   During pregnancy, this medication should be used only when||
9262|090|P|clearly needed. Discuss the risks and benefits with your doctor.||
9262|091|P|   It is unknown if this drug passes into breast milk. Consult||
9262|092|P|your doctor before breastfeeding.||
9262|093|B|||
9262|094|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9262|095|I|medications work or increase your risk for serious side effects.||
9262|096|I|This document does not contain all possible drug interactions.||
9262|097|I|Keep a list of all the products you use (including||
9262|098|I|prescription/nonprescription drugs and herbal products) and share||
9262|099|I|it with your doctor and pharmacist. Do not start, stop, or change||
9262|100|I|the dosage of any medicines without your doctor's approval.||
9262|101|I|   Some products that may interact with this drug include:||
9262|102|I|anti-cancer drugs (such as mechlorethamine, nitrogen mustard),||
9262|103|I|azole antifungals (such as ketoconazole, itraconazole),||
9262|104|I|cidofovir, digoxin, flucytosine, medications that affect the||
9262|105|I|kidneys (including pentamidine, tacrolimus, aminoglycosides such||
9262|106|I|as gentamicin), muscle relaxants (such as tubocurarine),||
9262|107|I|zidovudine.||
9262|108|I|   This medication may interfere with certain lab tests (such as||
9262|109|I|a phosphate levels), possibly causing false test results. Make||
9262|110|I|sure lab personnel and all your doctors know you use this drug.||
9262|111|B|||
9262|112|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9262|113|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9262|114|O|poison control center right away. US residents can call||
9262|115|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9262|116|B|||
9262|117|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
9262|118|N|potassium/magnesium levels, complete blood counts) should be done||
9262|119|N|while you are using this medication. Keep all medical and lab||
9262|120|N|appointments. Consult your doctor for more details.||
9262|121|B|||
9262|122|D|MISSED DOSE:  It is important to get each dose of this medication||
9262|123|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9262|124|D|right away for a new dosing schedule. Do not double the dose to||
9262|125|D|catch up.||
9262|126|B|||
9262|127|R|STORAGE:  Consult the product instructions and your pharmacist||
9262|128|R|for storage details. Keep all medications away from children and||
9262|129|R|pets.||
9262|130|R|   Do not flush medications down the toilet or pour them into a||
9262|131|R|drain unless instructed to do so. Properly discard this product||
9262|132|R|when it is expired or no longer needed. Consult your pharmacist||
9262|133|R|or local waste disposal company.||
9262|134|B|||
9262|135|A|Information last revised May 2025.||
9262|136|A|Copyright(c) 2025 First Databank, Inc.||
9262|137|B|||
9272|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9272|002|Z|does NOT have all possible information about this product. This||
9272|003|Z|information does not assure that this product is safe, effective,||
9272|004|Z|or appropriate for you. This information is not individual||
9272|005|Z|medical advice and does not substitute for the advice of your||
9272|006|Z|health care professional. Always ask your health care||
9272|007|Z|professional for complete information about this product and your||
9272|008|Z|specific health needs.||
9272|009|B|||
9272|010|T|CAPECITABINE - ORAL||
9272|011|F|(KAP-e-SYE-ta-been)||
9272|012|B|||
9272|013|C|COMMON BRAND NAME(S): Xeloda||
9272|014|B|||
9272|015|W|WARNING:  People with a certain enzyme deficiency||
9272|016|W|(dihydropyrimidine dehydrogenase - DPD) are at a higher risk of||
9272|017|W|serious side effects that may sometimes lead to death (see also||
9272|018|W|Side Effects section). To measure your risk, your doctor may||
9272|019|W|order a genetic test before you start this medication unless you||
9272|020|W|need treatment right away. If you have any questions, ask your||
9272|021|W|doctor or pharmacist.||
9272|022|W|   People taking capecitabine along with certain "blood thinners"||
9272|023|W|(anticoagulants such as warfarin) may have a higher chance of||
9272|024|W|serious, rarely fatal bleeding. Bleeding has occurred during||
9272|025|W|treatment and as long as one month after stopping capecitabine.||
9272|026|W|If you are using an anticoagulant, blood lab tests (INR/PT) will||
9272|027|W|be closely checked. Tell your doctor right away if you have any||
9272|028|W|signs of bleeding or bruising (such as bloody/black/tarry||
9272|029|W|stools).||
9272|030|B|||
9272|031|U|USES:  Capecitabine is used to treat certain types of cancer||
9272|032|U|(such as breast, colon, rectal, stomach, esophageal, pancreatic||
9272|033|U|cancer). It works by slowing or stopping the growth of cancer||
9272|034|U|cells.||
9272|035|B|||
9272|036|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9272|037|H|from your pharmacist before you start taking capecitabine and||
9272|038|H|each time you get a refill. If you have any questions, ask your||
9272|039|H|doctor or pharmacist.||
9272|040|H|   Take this medication by mouth as directed by your doctor,||
9272|041|H|usually twice daily (about 12 hours apart). Your doctor may||
9272|042|H|direct you to take this medication in a treatment cycle.||
9272|043|H|Carefully follow your doctor's instructions.||
9272|044|H|   Swallow the tablets whole with water within 30 minutes after a||
9272|045|H|meal. Do not crush, chew, or split the tablets. If you have||
9272|046|H|trouble swallowing the tablets whole, ask your health care||
9272|047|H|professional for advice.||
9272|048|H|   The dosage is based on your medical condition, body size, and||
9272|049|H|response to treatment. Do not increase your dose or use this drug||
9272|050|H|more often or for longer than prescribed. Your condition will not||
9272|051|H|improve any faster, and your risk of side effects will increase.||
9272|052|H|   If you vomit after taking a dose, do not take another dose at||
9272|053|H|that time. Take your next dose at the regular time.||
9272|054|H|   Since this drug can be absorbed through the skin and lungs and||
9272|055|H|may harm an unborn baby, women who are pregnant or who may become||
9272|056|H|pregnant should not handle this medication or breathe the dust||
9272|057|H|from the tablets.||
9272|058|B|||
9272|059|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, constipation,||
9272|060|S|tiredness, weakness, headache, dizziness, trouble sleeping, or||
9272|061|S|changes in taste may occur. Nausea and vomiting can be severe. In||
9272|062|S|some cases, your doctor may prescribe medication to prevent or||
9272|063|S|relieve nausea and vomiting. Eating several small meals, not||
9272|064|S|eating before treatment, or limiting activity may help lessen||
9272|065|S|some of these effects. If any of these effects last or get worse,||
9272|066|S|tell your doctor or pharmacist promptly.||
9272|067|S|   Diarrhea is a common side effect of this medication. Drink||
9272|068|S|plenty of fluids unless directed otherwise. Your doctor may also||
9272|069|S|prescribe medication (such as loperamide) to help lessen||
9272|070|S|diarrhea. Vomiting or diarrhea that doesn't stop may result in||
9272|071|S|dehydration. Contact your doctor promptly if you notice any||
9272|072|S|symptoms of dehydration, such as unusual decreased urination,||
9272|073|S|unusual dry mouth/thirst, or dizziness/lightheadedness.||
9272|074|S|   Temporary hair loss may occur. Normal hair growth should||
9272|075|S|return after treatment has ended. Also, temporary nail changes||
9272|076|S|may occur.||
9272|077|S|   People using this medication may have serious side effects.||
9272|078|S|However, you have been prescribed this drug because your doctor||
9272|079|S|has judged that the benefit to you is greater than the risk of||
9272|080|S|side effects. Careful monitoring by your doctor may decrease your||
9272|081|S|risk.||
9272|082|S|   Tell your doctor right away if you have any serious side||
9272|083|S|effects, including: severe nausea/vomiting (vomiting 2 or more||
9272|084|S|times per day, unable to eat or keep food/fluids in your||
9272|085|S|stomach), painful redness/swelling/sores in mouth or on your||
9272|086|S|tongue, easy bruising/bleeding, mental/mood changes (such as||
9272|087|S|depression), unusual tiredness, swelling of the ankles/feet,||
9272|088|S|vision changes, signs of kidney problems (such as change in the||
9272|089|S|amount of urine), yellowing eyes/skin, dark urine.||
9272|090|S|   Capecitabine may make you develop a skin problem called||
9272|091|S|hand-foot syndrome. To help prevent this, protect your hands and||
9272|092|S|feet from heat or increased pressure. Avoid activities such as||
9272|093|S|using hot dishwater, taking tub baths, jogging, long walks, or||
9272|094|S|using garden or household tools such as screwdrivers. Symptoms||
9272|095|S|may include pain, swelling, redness, blisters, or numbness of the||
9272|096|S|hands/feet. Your doctor may prescribe medication (such as balm)||
9272|097|S|to help with symptoms. If symptoms affect your usual activities,||
9272|098|S|get medical help right away.||
9272|099|S|   This medication may lower your ability to fight infections.||
9272|100|S|This may make you more likely to get a serious (rarely fatal)||
9272|101|S|infection or make any infection you have worse. Tell your doctor||
9272|102|S|right away if you have any signs of infections (such as sore||
9272|103|S|throat that doesn't go away, fever, chills).||
9272|104|S|   Get medical help right away if you have any very serious side||
9272|105|S|effects, including: chest/jaw/left arm pain, unusual sweating,||
9272|106|S|fainting, slow/fast/irregular heartbeat.||
9272|107|S|   A very serious allergic reaction to this drug is rare.||
9272|108|S|However, get medical help right away if you notice any symptoms||
9272|109|S|of a serious allergic reaction, such as: rash/blisters/peeling,||
9272|110|S|itching/swelling (especially of the face/tongue/throat), severe||
9272|111|S|dizziness, trouble breathing.||
9272|112|S|   This is not a complete list of possible side effects. If you||
9272|113|S|notice other side effects not listed above, contact your doctor||
9272|114|S|or pharmacist.||
9272|115|S|   In the US -||
9272|116|S|   Call your doctor for medical advice about side effects. You||
9272|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9272|118|S|www.fda.gov/medwatch.||
9272|119|S|   In Canada - Call your doctor for medical advice about side||
9272|120|S|effects. You may report side effects to Health Canada at||
9272|121|S|1-866-234-2345.||
9272|122|B|||
9272|123|P|PRECAUTIONS:  See also Warning section.||
9272|124|P|   Before taking capecitabine, tell your doctor or pharmacist if||
9272|125|P|you are allergic to it; or to 5-fluorouracil; or if you have any||
9272|126|P|other allergies. This product may contain inactive ingredients,||
9272|127|P|which can cause allergic reactions or other problems. Talk to||
9272|128|P|your pharmacist for more details.||
9272|129|P|   Before using this medication, tell your doctor or pharmacist||
9272|130|P|your medical history, especially of: blood disorders (such as||
9272|131|P|bone marrow suppression), heart problems (such as heart failure,||
9272|132|P|coronary artery disease), kidney disease, liver problems.||
9272|133|P|   Capecitabine can make you more likely to get infections or may||
9272|134|P|make current infections worse. Stay away from anyone who has an||
9272|135|P|infection that may easily spread (such as chickenpox, COVID-19,||
9272|136|P|measles, flu). Talk to your doctor if you have been exposed to an||
9272|137|P|infection or for more details.||
9272|138|P|   Tell your health care professional that you are using||
9272|139|P|capecitabine before having any immunizations/vaccinations. Avoid||
9272|140|P|contact with people who have recently received live vaccines||
9272|141|P|(such as flu vaccine inhaled through the nose).||
9272|142|P|   To lower the chance of getting cut, bruised, or injured, use||
9272|143|P|caution with sharp objects like razors and nail cutters, and||
9272|144|P|avoid activities such as contact sports.||
9272|145|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9272|146|P|can make you more dizzy. Do not drive, use machinery, or do||
9272|147|P|anything that needs alertness until you can do it safely. Limit||
9272|148|P|alcoholic beverages. Talk to your doctor if you are using||
9272|149|P|marijuana (cannabis).||
9272|150|P|   Before having surgery, tell your doctor or dentist about all||
9272|151|P|the products you use (including prescription drugs,||
9272|152|P|nonprescription drugs, and herbal products).||
9272|153|P|   Older adults may be more sensitive to the side effects of this||
9272|154|P|medication, especially nausea, vomiting, diarrhea, and hand-foot||
9272|155|P|syndrome.||
9272|156|P|   Tell your doctor if you are pregnant or plan to become||
9272|157|P|pregnant. You should not become pregnant while using||
9272|158|P|capecitabine. Capecitabine may harm an unborn baby. Your doctor||
9272|159|P|should order a pregnancy test before you start this medication.||
9272|160|P|Women using this medication should ask about reliable forms of||
9272|161|P|birth control during treatment and for 6 months after the last||
9272|162|P|dose. Men using this medication should ask about reliable forms||
9272|163|P|of birth control during treatment and for 3 months after the last||
9272|164|P|dose. If you or your partner becomes pregnant, talk to your||
9272|165|P|doctor right away about the risks and benefits of this||
9272|166|P|medication.||
9272|167|P|   Since this drug can be absorbed through the skin and lungs and||
9272|168|P|may harm an unborn baby, women who are pregnant or who may become||
9272|169|P|pregnant should not handle this medication or breathe the dust||
9272|170|P|from the tablets.||
9272|171|P|   It is unknown if this drug passes into breast milk. Because of||
9272|172|P|the possible risk to the infant, breastfeeding is not recommended||
9272|173|P|while using this drug and for 1 week after the last dose. Consult||
9272|174|P|your doctor before breastfeeding.||
9272|175|B|||
9272|176|I|DRUG INTERACTIONS:  See also Warning section.||
9272|177|I|   Drug interactions may change how your medications work or||
9272|178|I|increase your risk for serious side effects. This document does||
9272|179|I|not contain all possible drug interactions. Keep a list of all||
9272|180|I|the products you use (such as prescription/nonprescription drugs||
9272|181|I|and herbal products) and share it with your doctor and||
9272|182|I|pharmacist. Do not start, stop, or change the dosage of any||
9272|183|I|medicines without your doctor's approval.||
9272|184|I|   A product that may interact with this drug is: allopurinol.||
9272|185|I|   Capecitabine is very similar to fluorouracil. Do not use||
9272|186|I|medications containing fluorouracil while using capecitabine.||
9272|187|B|||
9272|188|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9272|189|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9272|190|O|poison control center right away. US residents can call||
9272|191|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9272|192|B|||
9272|193|N|NOTES:  Do not share this medication with others.||
9272|194|N|   Lab and/or medical tests (such as bilirubin, complete blood||
9272|195|N|counts, kidney/liver function, genetic testing) may be done||
9272|196|N|before you start using this medication and while you are using||
9272|197|N|it. Keep all medical and lab appointments.||
9272|198|B|||
9272|199|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
9272|200|D|next dose at the regular time and check with your doctor. Do not||
9272|201|D|double the dose to catch up.||
9272|202|B|||
9272|203|R|STORAGE:  Store at room temperature away from light and moisture.||
9272|204|R|Do not store in the bathroom. Keep all medications away from||
9272|205|R|children and pets.||
9272|206|R|   Do not flush medications down the toilet or pour them into a||
9272|207|R|drain unless instructed to do so. Properly discard this product||
9272|208|R|when it is expired or no longer needed. Consult your pharmacist||
9272|209|R|or local waste disposal company.||
9272|210|B|||
9272|211|M|MEDICAL ALERT:  Your condition can cause complications in a||
9272|212|M|medical emergency. For information about enrolling in MedicAlert,||
9272|213|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9272|214|B|||
9272|215|A|Information last revised October 2025.||
9272|216|A|Copyright(c) 2025 First Databank, Inc.||
9272|217|B|||
9273|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9273|002|Z|does NOT have all possible information about this product. This||
9273|003|Z|information does not assure that this product is safe, effective,||
9273|004|Z|or appropriate for you. This information is not individual||
9273|005|Z|medical advice and does not substitute for the advice of your||
9273|006|Z|health care professional. Always ask your health care||
9273|007|Z|professional for complete information about this product and your||
9273|008|Z|specific health needs.||
9273|009|B|||
9273|010|T|BICALUTAMIDE - ORAL||
9273|011|F|(BYE-ka-LOO-ta-mide)||
9273|012|B|||
9273|013|C|COMMON BRAND NAME(S): Casodex||
9273|014|B|||
9273|015|U|USES:  Bicalutamide is used to treat prostate cancer. This||
9273|016|U|medication works by blocking the action of hormones in the||
9273|017|U|prostate, slowing the growth of cancer cells.||
9273|018|U|   This medication should not be used in women and children.||
9273|019|B|||
9273|020|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9273|021|H|from your pharmacist before you start taking bicalutamide and||
9273|022|H|each time you get a refill. If you have any questions, ask your||
9273|023|H|doctor or pharmacist.||
9273|024|H|   Take this medication by mouth with or without food as directed||
9273|025|H|by your doctor, usually once a day.||
9273|026|H|   Use this medication regularly to get the most benefit from it.||
9273|027|H|To help you remember, take it at the same time each day.||
9273|028|H|   Do not increase your dose or use this drug more often or for||
9273|029|H|longer than prescribed. Your condition will not improve any||
9273|030|H|faster, and your risk of serious side effects will increase.||
9273|031|H|   Since this drug can be absorbed through the skin and lungs and||
9273|032|H|may harm an unborn baby, women who are pregnant or who may become||
9273|033|H|pregnant should not handle this medication or breathe the dust||
9273|034|H|from the tablets.||
9273|035|B|||
9273|036|S|SIDE EFFECTS:  Hot flashes, breast swelling/tenderness/pain,||
9273|037|S|nausea, vomiting, constipation, diarrhea, stomach upset, weight||
9273|038|S|changes, headache, trouble sleeping, drowsiness, or dizziness may||
9273|039|S|occur. If any of these effects last or get worse, tell your||
9273|040|S|doctor or pharmacist promptly.||
9273|041|S|   Remember that this medication has been prescribed because your||
9273|042|S|doctor has judged that the benefit to you is greater than the||
9273|043|S|risk of side effects. Many people using this medication do not||
9273|044|S|have serious side effects.||
9273|045|S|   Tell your doctor right away if you have any serious side||
9273|046|S|effects, including: increased thirst/urination, decreased sexual||
9273|047|S|ability/desire, mental/mood changes (such as anxiety,||
9273|048|S|depression), swelling hands/ankles/feet, shortness of breath,||
9273|049|S|increased coughing, numb/tingling skin, bone/joint pain, unusual||
9273|050|S|tiredness, muscle weakness, painful/bloody urination, signs of||
9273|051|S|infection (such as sore throat that doesn't go away, fever,||
9273|052|S|chills).||
9273|053|S|   Get medical help right away if you have any very serious side||
9273|054|S|effects, including: chest/jaw/left arm pain.||
9273|055|S|   This medication may rarely cause serious (possibly fatal)||
9273|056|S|liver disease. Get medical help right away if any of these side||
9273|057|S|effects occur: nausea/vomiting that doesn't stop, loss of||
9273|058|S|appetite, yellowing eyes/skin, stomach/abdominal pain, dark||
9273|059|S|urine.||
9273|060|S|   A very serious allergic reaction to this drug is rare.||
9273|061|S|However, get medical help right away if you notice any symptoms||
9273|062|S|of a serious allergic reaction, including: rash, itching/swelling||
9273|063|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9273|064|S|breathing.||
9273|065|S|   This is not a complete list of possible side effects. If you||
9273|066|S|notice other effects not listed above, contact your doctor or||
9273|067|S|pharmacist.||
9273|068|S|   In the US -||
9273|069|S|   Call your doctor for medical advice about side effects. You||
9273|070|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9273|071|S|www.fda.gov/medwatch.||
9273|072|S|   In Canada - Call your doctor for medical advice about side||
9273|073|S|effects. You may report side effects to Health Canada at||
9273|074|S|1-866-234-2345.||
9273|075|B|||
9273|076|P|PRECAUTIONS:  Before taking bicalutamide, tell your doctor or||
9273|077|P|pharmacist if you are allergic to it; or if you have any other||
9273|078|P|allergies. This product may contain inactive ingredients, which||
9273|079|P|can cause allergic reactions or other problems. Talk to your||
9273|080|P|pharmacist for more details.||
9273|081|P|   Before using this medication, tell your doctor or pharmacist||
9273|082|P|your medical history, especially of: liver disease, diabetes,||
9273|083|P|heart disease.||
9273|084|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9273|085|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9273|086|P|machinery, or do anything that needs alertness until you can do||
9273|087|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9273|088|P|are using marijuana (cannabis).||
9273|089|P|   This medication may make you more sensitive to the sun. Limit||
9273|090|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9273|091|P|sunscreen and wear protective clothing when outdoors. Tell your||
9273|092|P|doctor right away if you get sunburned or have skin||
9273|093|P|blisters/redness.||
9273|094|P|   Before having surgery, tell your doctor or dentist about all||
9273|095|P|the products you use (including prescription drugs,||
9273|096|P|nonprescription drugs, and herbal products).||
9273|097|P|   This medication should not be used in women, especially during||
9273|098|P|pregnancy or breastfeeding. It may harm an unborn or||
9273|099|P|breastfeeding baby. Consult your doctor for more details. Male||
9273|100|P|patients and their female partners should use reliable forms of||
9273|101|P|birth control during and for 130 days after treatment with||
9273|102|P|bicalutamide since this medication may damage sperm.||
9273|103|B|||
9273|104|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9273|105|I|medications work or increase your risk for serious side effects.||
9273|106|I|This document does not contain all possible drug interactions.||
9273|107|I|Keep a list of all the products you use (including||
9273|108|I|prescription/nonprescription drugs and herbal products) and share||
9273|109|I|it with your doctor and pharmacist. Do not start, stop, or change||
9273|110|I|the dosage of any medicines without your doctor's approval.||
9273|111|I|   Some products that may interact with this drug are: certain||
9273|112|I|"blood thinners" (such as warfarin).||
9273|113|B|||
9273|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9273|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9273|116|O|poison control center right away. US residents can call||
9273|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9273|118|B|||
9273|119|N|NOTES:  Do not share this medication with others.||
9273|120|N|   Lab and/or medical tests (such as PSA levels, liver function,||
9273|121|N|blood sugar, complete blood count) should be done while you are||
9273|122|N|taking this medication. Keep all medical and lab appointments.||
9273|123|N|Consult your doctor for more details.||
9273|124|B|||
9273|125|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
9273|126|D|next dose at the regular time. Do not double the dose to catch||
9273|127|D|up.||
9273|128|B|||
9273|129|R|STORAGE:  Store at room temperature away from light and moisture.||
9273|130|R|Do not store in the bathroom. Keep all medications away from||
9273|131|R|children and pets.||
9273|132|R|   Do not flush medications down the toilet or pour them into a||
9273|133|R|drain unless instructed to do so. Properly discard this product||
9273|134|R|when it is expired or no longer needed. Consult your pharmacist||
9273|135|R|or local waste disposal company.||
9273|136|B|||
9273|137|A|Information last revised May 2024.||
9273|138|A|Copyright(c) 2025 First Databank, Inc.||
9273|139|B|||
9274|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9274|002|Z|does NOT have all possible information about this product. This||
9274|003|Z|information does not assure that this product is safe, effective,||
9274|004|Z|or appropriate for you. This information is not individual||
9274|005|Z|medical advice and does not substitute for the advice of your||
9274|006|Z|health care professional. Always ask your health care||
9274|007|Z|professional for complete information about this product and your||
9274|008|Z|specific health needs.||
9274|009|B|||
9274|010|T|OLANZAPINE - ORAL||
9274|011|F|(oh-LAN-za-peen)||
9274|012|B|||
9274|013|C|COMMON BRAND NAME(S): Zyprexa||
9274|014|B|||
9274|015|W|WARNING:  There may be a slightly increased risk of serious,||
9274|016|W|possibly fatal side effects (such as stroke, heart failure,||
9274|017|W|fast/irregular heartbeat, pneumonia) when this medication is used||
9274|018|W|by older adults with dementia. This medication is not approved||
9274|019|W|for the treatment of dementia-related behavior problems. Discuss||
9274|020|W|the risks and benefits of this medication, as well as other||
9274|021|W|effective and possibly safer treatments for dementia-related||
9274|022|W|behavior problems, with the doctor.||
9274|023|W|   If you are using olanzapine in combination with other||
9274|024|W|medication to treat depression, also carefully read the drug||
9274|025|W|information for the other medication.||
9274|026|B|||
9274|027|U|USES:  This medication is used to treat certain mental/mood||
9274|028|U|disorders (such as schizophrenia, bipolar disorder). It may also||
9274|029|U|be used in combination with other medication to treat depression.||
9274|030|U|Olanzapine belongs to a class of drugs known as atypical||
9274|031|U|antipsychotics. It works by helping to restore the balance of||
9274|032|U|certain natural substances in the brain.||
9274|033|U|   Talk to the doctor about the risks and benefits of treatment||
9274|034|U|(especially when used by teenagers). See also Precautions||
9274|035|U|section.||
9274|036|B|||
9274|037|V|OTHER USES:  This section contains uses of this drug that are not||
9274|038|V|listed in the approved professional labeling for the drug but||
9274|039|V|that may be prescribed by your health care professional. Use this||
9274|040|V|drug for a condition that is listed in this section only if it||
9274|041|V|has been so prescribed by your health care professional.||
9274|042|V|   This drug may also be used to reduce the risk of nausea and||
9274|043|V|vomiting caused by cancer drug treatment (chemotherapy).||
9274|044|B|||
9274|045|H|HOW TO USE:  Read the Medication Guide provided by your||
9274|046|H|pharmacist before you start taking olanzapine and each time you||
9274|047|H|get a refill. If you have any questions, ask your doctor or||
9274|048|H|pharmacist.||
9274|049|H|   Take this medication by mouth with or without food as directed||
9274|050|H|by your doctor, usually once daily.||
9274|051|H|   The dosage is based on your medical condition and response to||
9274|052|H|treatment. To reduce your risk of side effects, your doctor may||
9274|053|H|direct you to start this medication at a low dose and gradually||
9274|054|H|increase your dose. Follow your doctor's instructions carefully.||
9274|055|H|   Take this medication regularly to get the most benefit from||
9274|056|H|it. To help you remember, take it at the same time each day. Keep||
9274|057|H|taking this medication even if you feel well. Do not stop taking||
9274|058|H|this medication without consulting your doctor.||
9274|059|H|   Tell your doctor if your condition lasts or gets worse.||
9274|060|B|||
9274|061|S|SIDE EFFECTS:  Drowsiness, dizziness, lightheadedness, stomach||
9274|062|S|upset, dry mouth, constipation, increased appetite, or weight||
9274|063|S|gain may occur. If any of these effects last or get worse, tell||
9274|064|S|your doctor or pharmacist promptly.||
9274|065|S|   Dizziness and lightheadedness can increase the risk of||
9274|066|S|falling. Get up slowly when rising from a sitting or lying||
9274|067|S|position.||
9274|068|S|   Remember that this medication has been prescribed because your||
9274|069|S|doctor has judged that the benefit to you is greater than the||
9274|070|S|risk of side effects. Many people using this medication do not||
9274|071|S|have serious side effects.||
9274|072|S|   Tell your doctor right away if you have any serious side||
9274|073|S|effects, including: difficulty swallowing, shaking (tremor), slow||
9274|074|S|heartbeat, fainting, mental/mood changes (such as confusion,||
9274|075|S|restlessness), numbness/tingling of arms/legs, yellowing||
9274|076|S|eyes/skin, severe stomach/abdominal pain, trouble urinating,||
9274|077|S|interrupted breathing during sleep.||
9274|078|S|   This drug may rarely make your blood sugar rise, which can||
9274|079|S|cause or worsen diabetes. Tell your doctor right away if you have||
9274|080|S|symptoms of high blood sugar such as increased thirst/urination.||
9274|081|S|If you already have diabetes, check your blood sugar regularly as||
9274|082|S|directed and share the results with your doctor. Your doctor may||
9274|083|S|need to adjust your diabetes medication, exercise program, or||
9274|084|S|diet.||
9274|085|S|   This drug may also cause significant weight gain and a rise in||
9274|086|S|your blood cholesterol (or triglyceride) levels, especially in||
9274|087|S|teenagers. These effects, along with diabetes, may increase your||
9274|088|S|risk for developing heart disease. Discuss the risks and benefits||
9274|089|S|of treatment with your doctor. (See also Notes section.)||
9274|090|S|   Olanzapine may rarely cause a condition known as tardive||
9274|091|S|dyskinesia. In some cases, this condition may be permanent. Tell||
9274|092|S|your doctor right away if you develop any unusual/uncontrolled||
9274|093|S|movements (especially of the face, lips, mouth, tongue, arms or||
9274|094|S|legs).||
9274|095|S|   This medication may increase a certain natural substance||
9274|096|S|(prolactin) made by your body. For females, this increase in||
9274|097|S|prolactin may result in unwanted breast milk, missed/stopped||
9274|098|S|periods, or difficulty becoming pregnant. For males, it may||
9274|099|S|result in decreased sexual ability, inability to produce sperm,||
9274|100|S|or enlarged breasts. If you develop any of these symptoms, tell||
9274|101|S|your doctor right away.||
9274|102|S|   Get medical help right away if you have any very serious side||
9274|103|S|effects, including: seizures.||
9274|104|S|   This medication may rarely cause a very serious condition||
9274|105|S|called neuroleptic malignant syndrome (NMS). Get medical help||
9274|106|S|right away if you have any of the following symptoms: fever,||
9274|107|S|muscle stiffness/pain/tenderness/weakness, severe tiredness,||
9274|108|S|severe confusion, sweating, fast/irregular heartbeat, dark urine,||
9274|109|S|signs of kidney problems (such as change in the amount of urine).||
9274|110|S|   A very serious allergic reaction to this drug is rare.||
9274|111|S|However, get medical help right away if you notice any symptoms||
9274|112|S|of a serious allergic reaction, including: fever, swollen lymph||
9274|113|S|nodes, rash, itching/swelling (especially of the||
9274|114|S|face/tongue/throat), severe dizziness, trouble breathing.||
9274|115|S|   This is not a complete list of possible side effects. If you||
9274|116|S|notice other effects not listed above, contact your doctor or||
9274|117|S|pharmacist.||
9274|118|S|   In the US -||
9274|119|S|   Call your doctor for medical advice about side effects. You||
9274|120|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9274|121|S|www.fda.gov/medwatch.||
9274|122|S|   In Canada - Call your doctor for medical advice about side||
9274|123|S|effects. You may report side effects to Health Canada at||
9274|124|S|1-866-234-2345.||
9274|125|B|||
9274|126|P|PRECAUTIONS:  Before taking olanzapine, tell your doctor or||
9274|127|P|pharmacist if you are allergic to it; or if you have any other||
9274|128|P|allergies. This product may contain inactive ingredients, which||
9274|129|P|can cause allergic reactions or other problems. Talk to your||
9274|130|P|pharmacist for more details.||
9274|131|P|   Before using this medication, tell your doctor or pharmacist||
9274|132|P|your medical history, especially of: liver problems, seizures,||
9274|133|P|difficulty swallowing, low white blood cell count, dementia,||
9274|134|P|difficulty urinating (for example, due to enlarged prostate),||
9274|135|P|glaucoma (narrow angle), stomach/intestinal problems (such as||
9274|136|P|blockage, chronic constipation, paralytic ileus), smoking,||
9274|137|P|personal or family history of diabetes, heart disease, high||
9274|138|P|cholesterol/triglyceride levels, breathing trouble during sleep||
9274|139|P|(sleep apnea).||
9274|140|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9274|141|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9274|142|P|machinery, or do anything that needs alertness until you can do||
9274|143|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
9274|144|P|are using marijuana (cannabis).||
9274|145|P|   Before having surgery, tell your doctor or dentist about all||
9274|146|P|the products you use (including prescription drugs,||
9274|147|P|nonprescription drugs, and herbal products).||
9274|148|P|   This medication may make you sweat less, making you more||
9274|149|P|likely to get heat stroke. Avoid doing things that may cause you||
9274|150|P|to overheat, such as hard work or exercise in hot weather, or||
9274|151|P|using hot tubs. When the weather is hot, drink a lot of fluids||
9274|152|P|and dress lightly. If you overheat, quickly look for a place to||
9274|153|P|cool down and rest. Get medical help right away if you have a||
9274|154|P|fever that does not go away, mental/mood changes, headache, or||
9274|155|P|dizziness.||
9274|156|P|   Teenagers may be more sensitive to the side effects of this||
9274|157|P|drug, especially weight gain, and also increased amounts of||
9274|158|P|cholesterol, triglycerides, and prolactin. See also Side Effects||
9274|159|P|section for more details.||
9274|160|P|   Older adults may be more sensitive to the side effects of this||
9274|161|P|drug, especially drowsiness, constipation, trouble urinating,||
9274|162|P|confusion, dizziness, and lightheadedness. Drowsiness, confusion,||
9274|163|P|dizziness, and lightheadedness can increase the risk of falling.||
9274|164|P|   During pregnancy, this medication should be used only when||
9274|165|P|clearly needed. Babies born to mothers who have used this drug||
9274|166|P|during the last 3 months of pregnancy may rarely develop symptoms||
9274|167|P|including muscle stiffness or shakiness, drowsiness,||
9274|168|P|feeding/breathing difficulties, or constant crying. If you notice||
9274|169|P|any of these symptoms in your newborn especially during their||
9274|170|P|first month, tell the doctor right away.||
9274|171|P|   Since untreated mental/mood problems (such as schizophrenia,||
9274|172|P|bipolar disorder, depression) can be a serious condition, do not||
9274|173|P|stop taking this medication unless directed by your doctor. If||
9274|174|P|you are planning pregnancy, become pregnant, or think you may be||
9274|175|P|pregnant, immediately discuss with your doctor the benefits and||
9274|176|P|risks of using this medication during pregnancy.||
9274|177|P|   This drug passes into breast milk and may have undesirable||
9274|178|P|effects on a nursing infant. Tell the doctor right away if your||
9274|179|P|baby develops symptoms such as muscle stiffness or shakiness,||
9274|180|P|unusual sleepiness, or difficulty feeding. Consult your doctor||
9274|181|P|before breastfeeding.||
9274|182|B|||
9274|183|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9274|184|I|medications work or increase your risk for serious side effects.||
9274|185|I|This document does not contain all possible drug interactions.||
9274|186|I|Keep a list of all the products you use (including||
9274|187|I|prescription/nonprescription drugs and herbal products) and share||
9274|188|I|it with your doctor and pharmacist. Do not start, stop, or change||
9274|189|I|the dosage of any medicines without your doctor's approval.||
9274|190|I|   A product that may interact with this drug is: metoclopramide.||
9274|191|I|   Tell your doctor or pharmacist if you are taking other||
9274|192|I|products that cause drowsiness such as opioid pain or cough||
9274|193|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9274|194|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9274|195|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9274|196|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
9274|197|I|diphenhydramine).||
9274|198|I|   Check the labels on all your medicines (such as allergy or||
9274|199|I|cough-and-cold products) because they may contain ingredients||
9274|200|I|that cause drowsiness. Ask your pharmacist about using those||
9274|201|I|products safely.||
9274|202|B|||
9274|203|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9274|204|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9274|205|O|poison control center right away. US residents can call||
9274|206|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9274|207|O|Symptoms of overdose may include: severe drowsiness/dizziness,||
9274|208|O|fast/irregular heartbeat, unusual/uncontrolled movements,||
9274|209|O|seizures.||
9274|210|B|||
9274|211|N|NOTES:  Do not share this medication with others.||
9274|212|N|   Lab and/or medical tests (such as blood sugar, weight, blood||
9274|213|N|pressure, blood cholesterol/triglyceride levels, liver function)||
9274|214|N|should be done while you are taking this medication. Keep all||
9274|215|N|medical and lab appointments. Consult your doctor for more||
9274|216|N|details.||
9274|217|B|||
9274|218|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9274|219|D|remember. If it is near the time of the next dose, skip the||
9274|220|D|missed dose. Take your next dose at the regular time. Do not||
9274|221|D|double the dose to catch up.||
9274|222|B|||
9274|223|R|STORAGE:  Store at room temperature away from light and moisture.||
9274|224|R|Do not store in the bathroom. Keep all medications away from||
9274|225|R|children and pets.||
9274|226|R|   Do not flush medications down the toilet or pour them into a||
9274|227|R|drain unless instructed to do so. Properly discard this product||
9274|228|R|when it is expired or no longer needed. Consult your pharmacist||
9274|229|R|or local waste disposal company.||
9274|230|B|||
9274|231|A|Information last revised May 2024.||
9274|232|A|Copyright(c) 2025 First Databank, Inc.||
9274|233|B|||
9275|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9275|002|Z|does NOT have all possible information about this product. This||
9275|003|Z|information does not assure that this product is safe, effective,||
9275|004|Z|or appropriate for you. This information is not individual||
9275|005|Z|medical advice and does not substitute for the advice of your||
9275|006|Z|health care professional. Always ask your health care||
9275|007|Z|professional for complete information about this product and your||
9275|008|Z|specific health needs.||
9275|009|B|||
9275|010|T|NEOMYCIN/BACITRACIN/POLYMYXIN - TOPICAL||
9275|011|F|(nee-oh-MY-sin/paw-lee-MIX-in/bass-eh-TRAY-sin)||
9275|012|B|||
9275|013|C|COMMON BRAND NAME(S): Mycitracin, Neosporin, Triple Antibiotic||
9275|014|B|||
9275|015|U|USES:  This medication is used to prevent and treat minor skin||
9275|016|U|infections caused by small cuts, scrapes, or burns. It is||
9275|017|U|available without a prescription for self-medication.||
9275|018|U|   Do not use this product over large areas of the body. Ask your||
9275|019|U|doctor first before using this product for serious skin injuries||
9275|020|U|or infections (such as deep cuts, puncture wounds, animal bites,||
9275|021|U|serious burns). A different treatment may be necessary for these||
9275|022|U|types of conditions.||
9275|023|U|   This product contains neomycin, bacitracin, and polymyxin,||
9275|024|U|antibiotics that work by stopping the growth of bacteria. This||
9275|025|U|medication prevents/treats only bacterial skin infections. It||
9275|026|U|will not work for other types of skin infections (such as||
9275|027|U|infections caused by fungi, viruses). Unnecessary use or misuse||
9275|028|U|of any antibiotic can lead to its decreased effectiveness.||
9275|029|B|||
9275|030|H|HOW TO USE:  This medication is for use on the skin only. Follow||
9275|031|H|all directions on the product package or use as directed by your||
9275|032|H|doctor. If you have any questions, ask your doctor or pharmacist.||
9275|033|H|   Clean and dry the affected skin area. If you are using the||
9275|034|H|ointment, wash your hands first. Then apply a small amount of||
9275|035|H|medication (no more than can fit on your finger tip) in a thin||
9275|036|H|layer on the skin and rub in gently, usually 1 to 3 times a day.||
9275|037|H|Wash your hands after applying the ointment. If you are using the||
9275|038|H|spray, shake the container well before using, then spray a small||
9275|039|H|amount on the affected area as directed, usually 1 to 3 times a||
9275|040|H|day. You may cover small treatment areas with a sterile bandage.||
9275|041|H|   Do not use large amounts of this medication or apply this more||
9275|042|H|often or for a longer period than directed. Your condition will||
9275|043|H|not clear faster, but the risk of side effects may be increased.||
9275|044|H|Do not use this product for longer than 1 week unless directed by||
9275|045|H|your doctor. Do not use this medication on irritated skin in a||
9275|046|H|child's diaper area unless directed by the doctor. After applying||
9275|047|H|the medication to the diaper area, do not use tight-fitting||
9275|048|H|diapers or plastic pants.||
9275|049|H|   Avoid getting this medication in your eyes or inside the nose||
9275|050|H|or mouth. If this occurs, wipe off the medication and rinse||
9275|051|H|thoroughly with water.||
9275|052|H|   Use this medication regularly in order to get the most benefit||
9275|053|H|from it. To help you remember, use it at the same time(s) each||
9275|054|H|day.||
9275|055|H|   Tell your doctor if your condition does not get better after a||
9275|056|H|few days or if it gets worse. If you think you may have a serious||
9275|057|H|medical problem, get medical help right away.||
9275|058|B|||
9275|059|S|SIDE EFFECTS:  This product usually has no side effects. If you||
9275|060|S|have any unusual effects, contact your doctor or pharmacist||
9275|061|S|promptly.||
9275|062|S|   If your doctor has directed you to use this medication,||
9275|063|S|remember that your doctor has judged that the benefit to you is||
9275|064|S|greater than the risk of side effects. Many people using this||
9275|065|S|medication do not have serious side effects.||
9275|066|S|   Rarely, use of this medication may result in other types of||
9275|067|S|skin infections (such as fungal or other bacterial infections).||
9275|068|S|Contact your doctor if you notice any unusual skin symptoms or if||
9275|069|S|your condition does not improve.||
9275|070|S|   A very serious allergic reaction to this product is rare.||
9275|071|S|However, get medical help right away if you notice any symptoms||
9275|072|S|of a serious allergic reaction, including: rash, itching/swelling||
9275|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9275|074|S|breathing.||
9275|075|S|   This is not a complete list of possible side effects. If you||
9275|076|S|notice other effects not listed above, contact your doctor or||
9275|077|S|pharmacist.||
9275|078|S|   In the US -||
9275|079|S|   Call your doctor for medical advice about side effects. You||
9275|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9275|081|S|www.fda.gov/medwatch.||
9275|082|S|   In Canada - Call your doctor for medical advice about side||
9275|083|S|effects. You may report side effects to Health Canada at||
9275|084|S|1-866-234-2345.||
9275|085|B|||
9275|086|P|PRECAUTIONS:  Before using this product, tell your doctor or||
9275|087|P|pharmacist if you are allergic to neomycin, bacitracin, or||
9275|088|P|polymyxin; or to aminoglycoside antibiotics (such as gentamicin,||
9275|089|P|tobramycin); or if you have any other allergies. This product may||
9275|090|P|contain inactive ingredients, which can cause allergic reactions||
9275|091|P|or other problems. Talk to your pharmacist for more details.||
9275|092|P|   During pregnancy, this medication should be used only when||
9275|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
9275|094|P|   It is unknown if the medications in this product pass into||
9275|095|P|breast milk. Consult your doctor before breastfeeding.||
9275|096|B|||
9275|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9275|098|I|medications work or increase your risk for serious side effects.||
9275|099|I|This document does not contain all possible drug interactions.||
9275|100|I|Keep a list of all the products you use (including||
9275|101|I|prescription/nonprescription drugs and herbal products) and share||
9275|102|I|it with your health care professional. Do not start, stop, or||
9275|103|I|change the dosage of any medicines without your doctor's||
9275|104|I|approval.||
9275|105|B|||
9275|106|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9275|107|O|has overdosed and has serious symptoms such as passing out or||
9275|108|O|trouble breathing, call 911. Otherwise, call a poison control||
9275|109|O|center right away. US residents can call 1-800-222-1222. Canada||
9275|110|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9275|111|O|include: hearing problems, change in the amount of urine.||
9275|112|B|||
9275|113|N|NOTES:  Keep all medical and lab appointments.||
9275|114|B|||
9275|115|D|MISSED DOSE:  If you miss a dose, apply the medication as soon as||
9275|116|D|you remember. If it is near the time of the next dose, skip the||
9275|117|D|missed dose. Use your next dose at the regular time. Do not||
9275|118|D|double the dose to catch up.||
9275|119|B|||
9275|120|R|STORAGE:  Store at room temperature. Keep all medications away||
9275|121|R|from children and pets.||
9275|122|R|   Do not flush medications down the toilet or pour them into a||
9275|123|R|drain unless instructed to do so. Properly discard this product||
9275|124|R|when it is expired or no longer needed. Consult your pharmacist||
9275|125|R|or local waste disposal company.||
9275|126|B|||
9275|127|A|Information last revised February 2025.||
9275|128|A|Copyright(c) 2025 First Databank, Inc.||
9275|129|B|||
9277|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9277|002|Z|does NOT have all possible information about this product. This||
9277|003|Z|information does not assure that this product is safe, effective,||
9277|004|Z|or appropriate for you. This information is not individual||
9277|005|Z|medical advice and does not substitute for the advice of your||
9277|006|Z|health care professional. Always ask your health care||
9277|007|Z|professional for complete information about this product and your||
9277|008|Z|specific health needs.||
9277|009|B|||
9277|010|T|ZILEUTON - ORAL||
9277|011|F|(zye-LOO-ton)||
9277|012|B|||
9277|013|C|COMMON BRAND NAME(S): Zyflo||
9277|014|B|||
9277|015|U|USES:  Zileuton is used to control and prevent symptoms (such as||
9277|016|U|wheezing and shortness of breath) caused by asthma. Controlling||
9277|017|U|symptoms of asthma helps you maintain your normal activities and||
9277|018|U|cuts down on time lost from work or school.||
9277|019|U|   This medication must be used regularly to be effective. It||
9277|020|U|does not work right away and should not be used to relieve sudden||
9277|021|U|asthma attacks. If an asthma attack occurs, use your quick-relief||
9277|022|U|inhaler (such as albuterol, salbutamol) as prescribed.||
9277|023|U|   This drug is not recommended for use in children younger than||
9277|024|U|12 years due to possible risk of liver problems.||
9277|025|B|||
9277|026|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9277|027|H|from your pharmacist before you start taking zileuton and each||
9277|028|H|time you get a refill. If you have any questions, ask your doctor||
9277|029|H|or pharmacist.||
9277|030|H|   Take this medication by mouth with or without food as directed||
9277|031|H|by your doctor, usually 4 times daily.||
9277|032|H|   Use this medication regularly to get the most benefit from it.||
9277|033|H|To help you remember, take it at the same times each day. Keep||
9277|034|H|taking this medication even if you feel well. Do not increase||
9277|035|H|your dose, use this drug more often, or stop using it without||
9277|036|H|first consulting your doctor.||
9277|037|H|   Get medical help right away if your asthma symptoms worsen or||
9277|038|H|if you are using your quick-relief inhaler more than usual or||
9277|039|H|more often than prescribed.||
9277|040|B|||
9277|041|S|SIDE EFFECTS:  Stomach upset or abdominal pain may occur. If||
9277|042|S|either of these effects lasts or gets worse, tell your doctor or||
9277|043|S|pharmacist promptly.||
9277|044|S|   Remember that this medication has been prescribed because your||
9277|045|S|doctor has judged that the benefit to you is greater than the||
9277|046|S|risk of side effects. Many people using this medication do not||
9277|047|S|have serious side effects.||
9277|048|S|   Tell your doctor right away if you have any serious side||
9277|049|S|effects, including: symptoms of liver disease (such as||
9277|050|S|nausea/vomiting that doesn't stop, loss of appetite,||
9277|051|S|stomach/abdominal pain, yellowing eyes/skin, dark urine),||
9277|052|S|mental/mood changes (such as trouble sleeping, agitation,||
9277|053|S|hallucinations, depression, thoughts of suicide).||
9277|054|S|   A very serious allergic reaction to this drug is rare.||
9277|055|S|However, get medical help right away if you notice any symptoms||
9277|056|S|of a serious allergic reaction, including: rash, itching/swelling||
9277|057|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9277|058|S|breathing.||
9277|059|S|   This is not a complete list of possible side effects. If you||
9277|060|S|notice other effects not listed above, contact your doctor or||
9277|061|S|pharmacist.||
9277|062|S|   In the US -||
9277|063|S|   Call your doctor for medical advice about side effects. You||
9277|064|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9277|065|S|www.fda.gov/medwatch.||
9277|066|S|   In Canada - Call your doctor for medical advice about side||
9277|067|S|effects. You may report side effects to Health Canada at||
9277|068|S|1-866-234-2345.||
9277|069|B|||
9277|070|P|PRECAUTIONS:  Before taking zileuton, tell your doctor or||
9277|071|P|pharmacist if you are allergic to it; or if you have any other||
9277|072|P|allergies. This product may contain inactive ingredients, which||
9277|073|P|can cause allergic reactions or other problems. Talk to your||
9277|074|P|pharmacist for more details.||
9277|075|P|   Before using this medication, tell your doctor or pharmacist||
9277|076|P|your medical history, especially of: liver disease, alcohol use.||
9277|077|P|   Before having surgery, tell your doctor or dentist about all||
9277|078|P|the products you use (including prescription drugs,||
9277|079|P|nonprescription drugs, and herbal products).||
9277|080|P|   Older women may be at greater risk for liver problems while||
9277|081|P|using this drug.||
9277|082|P|   During pregnancy, this medication should be used only when||
9277|083|P|clearly needed. Discuss the risks and benefits with your doctor.||
9277|084|P|   It is unknown if this medication passes into breast milk.||
9277|085|P|Consult your doctor before breastfeeding.||
9277|086|B|||
9277|087|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9277|088|I|medications work or increase your risk for serious side effects.||
9277|089|I|This document does not contain all possible drug interactions.||
9277|090|I|Keep a list of all the products you use (including||
9277|091|I|prescription/nonprescription drugs and herbal products) and share||
9277|092|I|it with your doctor and pharmacist. Do not start, stop, or change||
9277|093|I|the dosage of any medicines without your doctor's approval.||
9277|094|I|   This medication can slow down the removal of other medications||
9277|095|I|from your body, which may affect how they work. Examples of||
9277|096|I|affected drugs include fezolinetant, pimozide, among others.||
9277|097|B|||
9277|098|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9277|099|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9277|100|O|poison control center right away. US residents can call||
9277|101|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9277|102|B|||
9277|103|N|NOTES:  Do not share this medication with others.||
9277|104|N|   Lab and/or medical tests (such as liver/lung function) should||
9277|105|N|be done while you are taking this medication. Keep all medical||
9277|106|N|and lab appointments. Consult your doctor for more details.||
9277|107|N|   Avoid substances that can worsen breathing problems by causing||
9277|108|N|irritation or allergic reaction, such as smoke, pollen, pet||
9277|109|N|dander, dust, and mold.||
9277|110|B|||
9277|111|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9277|112|D|remember. If it is near the time of the next dose, skip the||
9277|113|D|missed dose. Take your next dose at the regular time. Do not||
9277|114|D|double the dose to catch up.||
9277|115|B|||
9277|116|R|STORAGE:  Store at room temperature away from light and moisture.||
9277|117|R|Do not store in the bathroom. Keep all medications away from||
9277|118|R|children and pets.||
9277|119|R|   Do not flush medications down the toilet or pour them into a||
9277|120|R|drain unless instructed to do so. Properly discard this product||
9277|121|R|when it is expired or no longer needed. Consult your pharmacist||
9277|122|R|or local waste disposal company.||
9277|123|B|||
9277|124|M|MEDICAL ALERT:  Your condition can cause complications in a||
9277|125|M|medical emergency. For information about enrolling in MedicAlert,||
9277|126|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9277|127|B|||
9277|128|A|Information last revised May 2024.||
9277|129|A|Copyright(c) 2025 First Databank, Inc.||
9277|130|B|||
9280|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9280|002|Z|does NOT have all possible information about this product. This||
9280|003|Z|information does not assure that this product is safe, effective,||
9280|004|Z|or appropriate for you. This information is not individual||
9280|005|Z|medical advice and does not substitute for the advice of your||
9280|006|Z|health care professional. Always ask your health care||
9280|007|Z|professional for complete information about this product and your||
9280|008|Z|specific health needs.||
9280|009|B|||
9280|010|T|MULTIVITAMINS W/IRON (INCLUDES PRENATAL) TIME RELEASE - ORAL||
9280|011|B|||
9280|012|W|WARNING:  Accidental overdose of iron-containing products is a||
9280|013|W|leading cause of fatal poisoning in children younger than 6||
9280|014|W|years. Keep this product out of reach of children. If overdose||
9280|015|W|does occur, get medical help right away or call a poison control||
9280|016|W|center.||
9280|017|B|||
9280|018|U|USES:  This medication is a multivitamin and iron product used to||
9280|019|U|treat or prevent vitamin deficiency due to poor diet, certain||
9280|020|U|illnesses, or during pregnancy. Vitamins and iron are important||
9280|021|U|building blocks of the body and help keep you in good health.||
9280|022|B|||
9280|023|H|HOW TO USE:  Take this medication by mouth, usually once daily or||
9280|024|H|as directed. Follow all directions on the product package, or||
9280|025|H|take as directed by your doctor. Do not take more than the||
9280|026|H|recommended dosage. If you have any questions, ask your doctor or||
9280|027|H|pharmacist.||
9280|028|H|   Do not crush or chew this medication. Doing so can release all||
9280|029|H|of the drug at once, increasing the risk of side effects. Also,||
9280|030|H|do not split the tablets unless they have a score line and your||
9280|031|H|doctor or pharmacist tells you to do so. Swallow the whole or||
9280|032|H|split tablet without crushing or chewing.||
9280|033|H|   This medication is best taken on an empty stomach 1 hour||
9280|034|H|before or 2 hours after meals. Take with a full glass of water (8||
9280|035|H|ounces or 240 milliliters) unless your doctor directs you||
9280|036|H|otherwise. If stomach upset occurs, you may take this medication||
9280|037|H|with food. Avoid taking antacids, dairy products, tea, or coffee||
9280|038|H|within 2 hours before or after this medication because they will||
9280|039|H|decrease its effectiveness. Do not lie down for at least 10||
9280|040|H|minutes after taking this medication.||
9280|041|H|   Take this medication regularly in order to get the most||
9280|042|H|benefit from it. To help you remember, take it at the same time||
9280|043|H|each day.||
9280|044|B|||
9280|045|S|SIDE EFFECTS:  Constipation, diarrhea, or upset stomach may||
9280|046|S|occur. These effects are usually temporary and may disappear as||
9280|047|S|your body adjusts to this medication. If any of these effects||
9280|048|S|last or get worse, tell your doctor or pharmacist promptly.||
9280|049|S|   Iron may cause your stools to turn black, an effect that is||
9280|050|S|not harmful.||
9280|051|S|   If your doctor has prescribed this medication, remember that||
9280|052|S|your doctor has judged that the benefit to you is greater than||
9280|053|S|the risk of side effects. Many people using this medication do||
9280|054|S|not have serious side effects.||
9280|055|S|   A very serious allergic reaction to this drug is rare.||
9280|056|S|However, get medical help right away if you notice any symptoms||
9280|057|S|of a serious allergic reaction, including: rash, itching/swelling||
9280|058|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9280|059|S|breathing.||
9280|060|S|   This is not a complete list of possible side effects. If you||
9280|061|S|notice other effects not listed above, contact your doctor or||
9280|062|S|pharmacist.||
9280|063|S|   In the US -||
9280|064|S|   Call your doctor for medical advice about side effects. You||
9280|065|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9280|066|S|www.fda.gov/medwatch.||
9280|067|S|   In Canada - Call your doctor for medical advice about side||
9280|068|S|effects. You may report side effects to Health Canada at||
9280|069|S|1-866-234-2345.||
9280|070|B|||
9280|071|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
9280|072|P|pharmacist if you are allergic to any of its ingredients; or if||
9280|073|P|you have any other allergies. This product may contain inactive||
9280|074|P|ingredients, which can cause allergic reactions or other||
9280|075|P|problems. Talk to your pharmacist for more details.||
9280|076|P|   Before taking this medication, tell your doctor or pharmacist||
9280|077|P|your medical history, especially of: iron overload disorder (such||
9280|078|P|as hemochromatosis, hemosiderosis), use/abuse of alcohol, liver||
9280|079|P|problems, stomach/intestinal problems (such as ulcer, colitis).||
9280|080|P|   If your brand of multivitamin also contains folic acid, be||
9280|081|P|sure to tell your doctor or pharmacist if you have vitamin B12||
9280|082|P|deficiency (pernicious anemia) before taking it. Folic acid may||
9280|083|P|affect certain lab tests for vitamin B12 deficiency without||
9280|084|P|treating this anemia. Untreated vitamin B12 deficiency may result||
9280|085|P|in serious nerve problems (such as peripheral neuropathy).||
9280|086|P|Consult your doctor or pharmacist for details.||
9280|087|P|   Before having surgery, tell your doctor or dentist about all||
9280|088|P|the products you use (including prescription drugs,||
9280|089|P|nonprescription drugs, and herbal products).||
9280|090|P|   Tell your doctor if you are pregnant before using this||
9280|091|P|medication.||
9280|092|P|   This medication passes into breast milk. Consult your doctor||
9280|093|P|before breastfeeding.||
9280|094|B|||
9280|095|I|DRUG INTERACTIONS:  See also How To Use section.||
9280|096|I|   Drug interactions may change how your medications work or||
9280|097|I|increase your risk for serious side effects. This document does||
9280|098|I|not contain all possible drug interactions. Keep a list of all||
9280|099|I|the products you use (including prescription/nonprescription||
9280|100|I|drugs and herbal products) and share it with your doctor and||
9280|101|I|pharmacist. Do not start, stop, or change the dosage of any||
9280|102|I|medicines without your doctor's approval.||
9280|103|I|   This product can decrease the absorption of certain drugs,||
9280|104|I|especially if you take them around the same time. These drugs||
9280|105|I|include bisphosphonates (such as alendronate), levodopa,||
9280|106|I|penicillamine, quinolone antibiotics (such as ciprofloxacin,||
9280|107|I|levofloxacin), tetracycline antibiotics (such as doxycycline,||
9280|108|I|minocycline), thyroid medications (such as levothyroxine), among||
9280|109|I|others. Ask your doctor or pharmacist how long you should wait||
9280|110|I|between doses of this product and your other medications and to||
9280|111|I|find a dosing schedule that works for all your medications.||
9280|112|B|||
9280|113|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9280|114|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9280|115|O|poison control center right away. US residents can call||
9280|116|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9280|117|O|Symptoms of overdose may include: stomach pain, nausea, vomiting,||
9280|118|O|diarrhea.||
9280|119|B|||
9280|120|N|NOTES:  If your doctor has prescribed this medication, do not||
9280|121|N|share it with others.||
9280|122|N|   Keep all medical and lab appointments.||
9280|123|N|   Some brands may also contain ingredients such as docusate. Ask||
9280|124|N|your doctor or pharmacist if you have questions about the||
9280|125|N|ingredients in your brand.||
9280|126|N|   This product is not a substitute for a proper diet. Remember||
9280|127|N|that it is best to get your vitamins and minerals from healthy||
9280|128|N|foods. Maintain a well-balanced diet and follow any dietary||
9280|129|N|guidelines as directed by your doctor.||
9280|130|B|||
9280|131|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9280|132|D|remember. If it is near the time of the next dose, skip the||
9280|133|D|missed dose. Take your next dose at the regular time. Do not||
9280|134|D|double the dose to catch up.||
9280|135|B|||
9280|136|R|STORAGE:  Store at room temperature away from light and moisture.||
9280|137|R|Do not store in the bathroom. Keep all medications away from||
9280|138|R|children and pets.||
9280|139|R|   Do not flush medications down the toilet or pour them into a||
9280|140|R|drain unless instructed to do so. Properly discard this product||
9280|141|R|when it is expired or no longer needed. Consult your pharmacist||
9280|142|R|or local waste disposal company.||
9280|143|B|||
9280|144|A|Information last revised October 2025.||
9280|145|A|Copyright(c) 2025 First Databank, Inc.||
9280|146|B|||
9281|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9281|002|Z|does NOT have all possible information about this product. This||
9281|003|Z|information does not assure that this product is safe, effective,||
9281|004|Z|or appropriate for you. This information is not individual||
9281|005|Z|medical advice and does not substitute for the advice of your||
9281|006|Z|health care professional. Always ask your health care||
9281|007|Z|professional for complete information about this product and your||
9281|008|Z|specific health needs.||
9281|009|B|||
9281|010|T|PERINDOPRIL - ORAL||
9281|011|F|(per-IN-doh-prill)||
9281|012|B|||
9281|013|C|COMMON BRAND NAME(S): Aceon||
9281|014|B|||
9281|015|W|WARNING:  Perindopril can cause serious (possibly fatal) harm to||
9281|016|W|an unborn baby if used during pregnancy. It is important to||
9281|017|W|prevent pregnancy while taking this medication. Consult your||
9281|018|W|doctor for more details and to discuss the use of reliable forms||
9281|019|W|of birth control while taking this medication. If you are||
9281|020|W|planning pregnancy, become pregnant, or think you may be||
9281|021|W|pregnant, tell your doctor right away.||
9281|022|B|||
9281|023|U|USES:  Perindopril is used to treat high blood pressure. Lowering||
9281|024|U|high blood pressure helps prevent strokes, heart attacks, and||
9281|025|U|kidney problems. This medication is also used to prevent heart||
9281|026|U|attacks in people with a certain type of heart disease (stable||
9281|027|U|coronary artery disease). Perindopril belongs to a class of drugs||
9281|028|U|known as ACE inhibitors. It works by relaxing blood vessels so||
9281|029|U|blood can flow more easily.||
9281|030|B|||
9281|031|V|OTHER USES:  This section contains uses of this drug that are not||
9281|032|V|listed in the approved professional labeling for the drug but||
9281|033|V|that may be prescribed by your health care professional. Use this||
9281|034|V|drug for a condition that is listed in this section only if it||
9281|035|V|has been so prescribed by your health care professional.||
9281|036|V|   This drug may also be used for heart failure. It may also be||
9281|037|V|used for kidney disease and to help protect the kidneys from harm||
9281|038|V|due to diabetes.||
9281|039|B|||
9281|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9281|041|H|from your pharmacist before you start taking perindopril and each||
9281|042|H|time you get a refill. If you have any questions, ask your doctor||
9281|043|H|or pharmacist.||
9281|044|H|   Take this medication by mouth as directed by your doctor,||
9281|045|H|usually once or twice daily. The dosage is based on your medical||
9281|046|H|condition and response to treatment.||
9281|047|H|   To reduce your risk of side effects, your doctor may direct||
9281|048|H|you to start this medication at a low dose and gradually increase||
9281|049|H|your dose. Follow your doctor's instructions carefully.||
9281|050|H|   Take this medication regularly to get the most benefit from||
9281|051|H|it. To help you remember, take it at the same time(s) each day.||
9281|052|H|Keep taking this medication even if you feel well. Most people||
9281|053|H|with high blood pressure do not feel sick.||
9281|054|H|   It may take several weeks before you get the full benefit of||
9281|055|H|this drug.||
9281|056|H|   Tell your doctor if your condition does not get better or if||
9281|057|H|it gets worse (for example, your blood pressure readings remain||
9281|058|H|high or increase).||
9281|059|B|||
9281|060|S|SIDE EFFECTS:  Dizziness, lightheadedness, or tiredness may occur||
9281|061|S|as your body adjusts to the medication. Dry cough may also occur.||
9281|062|S|If any of these effects last or get worse, tell your doctor or||
9281|063|S|pharmacist promptly.||
9281|064|S|   To reduce the risk of dizziness and lightheadedness, get up||
9281|065|S|slowly when rising from a sitting or lying position.||
9281|066|S|   Remember that this medication has been prescribed because your||
9281|067|S|doctor has judged that the benefit to you is greater than the||
9281|068|S|risk of side effects. Many people using this medication do not||
9281|069|S|have serious side effects.||
9281|070|S|   Tell your doctor right away if you have any serious side||
9281|071|S|effects, including: symptoms of a high potassium blood level||
9281|072|S|(such as muscle weakness, slow/irregular heartbeat), fainting.||
9281|073|S|   Although perindopril may be used to prevent kidney problems or||
9281|074|S|treat people who have kidney problems, it may also rarely cause||
9281|075|S|kidney problems or make them worse. Your doctor will check your||
9281|076|S|kidney function while you are taking this medication. Tell your||
9281|077|S|doctor right away if you have any signs of kidney problems such||
9281|078|S|as a change in the amount of urine.||
9281|079|S|   This drug may rarely cause serious (possibly fatal) liver||
9281|080|S|problems. Get medical help right away if you have any symptoms of||
9281|081|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
9281|082|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
9281|083|S|urine.||
9281|084|S|   A very serious allergic reaction to this drug is rare.||
9281|085|S|However, get medical help right away if you notice any symptoms||
9281|086|S|of a serious allergic reaction, including: rash, itching/swelling||
9281|087|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9281|088|S|breathing.||
9281|089|S|   This is not a complete list of possible side effects. If you||
9281|090|S|notice other effects not listed above, contact your doctor or||
9281|091|S|pharmacist.||
9281|092|S|   In the US -||
9281|093|S|   Call your doctor for medical advice about side effects. You||
9281|094|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9281|095|S|www.fda.gov/medwatch.||
9281|096|S|   In Canada - Call your doctor for medical advice about side||
9281|097|S|effects. You may report side effects to Health Canada at||
9281|098|S|1-866-234-2345.||
9281|099|B|||
9281|100|P|PRECAUTIONS:  Before taking perindopril, tell your doctor or||
9281|101|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
9281|102|P|(such as captopril, lisinopril); or if you have any other||
9281|103|P|allergies. This product may contain inactive ingredients, which||
9281|104|P|can cause allergic reactions or other problems. Talk to your||
9281|105|P|pharmacist for more details.||
9281|106|P|   Before using this medication, tell your doctor or pharmacist||
9281|107|P|your medical history, especially of: history of an allergic||
9281|108|P|reaction which included swelling of the face/lips/tongue/throat||
9281|109|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
9281|110|P|dialysis), high level of potassium in the blood, liver disease.||
9281|111|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9281|112|P|can make you more dizzy. Do not drive, use machinery, or do||
9281|113|P|anything that needs alertness until you can do it safely. Limit||
9281|114|P|alcoholic beverages. Talk to your doctor if you are using||
9281|115|P|marijuana (cannabis).||
9281|116|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
9281|117|P|and cause you to feel lightheaded. Tell your doctor if you have||
9281|118|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
9281|119|P|of fluids unless your doctor tells you not to.||
9281|120|P|   This medication may increase your potassium levels. Before||
9281|121|P|using potassium supplements or salt substitutes that contain||
9281|122|P|potassium, consult your doctor or pharmacist.||
9281|123|P|   Before having surgery, tell your doctor or dentist about all||
9281|124|P|the products you use (including prescription drugs,||
9281|125|P|nonprescription drugs, and herbal products).||
9281|126|P|   Older adults may be more sensitive to the side effects of this||
9281|127|P|drug, especially dizziness, high potassium levels, and rash.||
9281|128|P|   Tell your doctor if you are pregnant or plan to become||
9281|129|P|pregnant. You should not become pregnant while using perindopril.||
9281|130|P|Perindopril may harm an unborn baby. If you become pregnant, talk||
9281|131|P|to your doctor right away about the risks and benefits of this||
9281|132|P|medication. (See also Warning section.)||
9281|133|P|   It is unknown if perindopril passes into breast milk. Consult||
9281|134|P|your doctor before breastfeeding.||
9281|135|B|||
9281|136|I|DRUG INTERACTIONS:  See also Precautions section.||
9281|137|I|   Drug interactions may change how your medications work or||
9281|138|I|increase your risk for serious side effects. This document does||
9281|139|I|not contain all possible drug interactions. Keep a list of all||
9281|140|I|the products you use (including prescription/nonprescription||
9281|141|I|drugs and herbal products) and share it with your doctor and||
9281|142|I|pharmacist. Do not start, stop, or change the dosage of any||
9281|143|I|medicines without your doctor's approval.||
9281|144|I|   Some products that may interact with this drug include:||
9281|145|I|aliskiren, gold injections, lithium, sacubitril, certain drugs||
9281|146|I|that weaken the immune system/increase the risk of infection||
9281|147|I|(such as everolimus, sirolimus), drugs that may increase the||
9281|148|I|level of potassium in the blood (such as ARBs including||
9281|149|I|losartan/valsartan, birth control pills containing drospirenone).||
9281|150|I|   Some products have ingredients that could raise your blood||
9281|151|I|pressure or worsen your heart failure. Tell your pharmacist what||
9281|152|I|products you are using, and ask how to use them safely||
9281|153|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
9281|154|I|ibuprofen/naproxen).||
9281|155|I|   A very serious reaction may occur if you are getting||
9281|156|I|injections for bee/wasp sting allergy (desensitization) and are||
9281|157|I|also taking perindopril. Make sure all your doctors know which||
9281|158|I|medicines you are using.||
9281|159|B|||
9281|160|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9281|161|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9281|162|O|poison control center right away. US residents can call||
9281|163|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9281|164|O|Symptoms of overdose may include severe dizziness, weakness,||
9281|165|O|fainting.||
9281|166|B|||
9281|167|N|NOTES:  Do not share this medication with others.||
9281|168|N|   Lifestyle changes that may help this medication work better||
9281|169|N|include exercising, stopping smoking, and eating a||
9281|170|N|low-cholesterol/low-fat diet. Consult your doctor for more||
9281|171|N|details.||
9281|172|N|   Lab and/or medical tests (such as kidney function, potassium||
9281|173|N|levels) should be done while you are taking this medication. Keep||
9281|174|N|all medical and lab appointments. Consult your doctor for more||
9281|175|N|details.||
9281|176|N|   Check your blood pressure and pulse (heart rate) regularly||
9281|177|N|while taking this medication. Learn how to check your own blood||
9281|178|N|pressure and pulse at home, and share the results with your||
9281|179|N|doctor.||
9281|180|B|||
9281|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9281|182|D|remember. If it is near the time of the next dose, skip the||
9281|183|D|missed dose. Take your next dose at the regular time. Do not||
9281|184|D|double the dose to catch up.||
9281|185|B|||
9281|186|R|STORAGE:  Store at room temperature away from light and moisture.||
9281|187|R|Do not store in the bathroom. Keep all medications away from||
9281|188|R|children and pets.||
9281|189|R|   Do not flush medications down the toilet or pour them into a||
9281|190|R|drain unless instructed to do so. Properly discard this product||
9281|191|R|when it is expired or no longer needed. Consult your pharmacist||
9281|192|R|or local waste disposal company.||
9281|193|B|||
9281|194|A|Information last revised May 2024.||
9281|195|A|Copyright(c) 2025 First Databank, Inc.||
9281|196|B|||
9288|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9288|002|Z|does NOT have all possible information about this product. This||
9288|003|Z|information does not assure that this product is safe, effective,||
9288|004|Z|or appropriate for you. This information is not individual||
9288|005|Z|medical advice and does not substitute for the advice of your||
9288|006|Z|health care professional. Always ask your health care||
9288|007|Z|professional for complete information about this product and your||
9288|008|Z|specific health needs.||
9288|009|B|||
9288|010|T|CYANOCOBALAMIN - NASAL||
9288|011|F|(SYE-an-oh-koe-BAL-a-min)||
9288|012|B|||
9288|013|C|COMMON BRAND NAME(S): Nascobal||
9288|014|B|||
9288|015|U|USES:  Cyanocobalamin is a man-made form of vitamin B12 used to||
9288|016|U|treat low levels (deficiency) of this vitamin. Vitamin B12 helps||
9288|017|U|your body use fat and carbohydrates for energy and make new||
9288|018|U|protein. It is also important for normal blood, cells, and||
9288|019|U|nerves. Most people get enough vitamin B12 in their diet, but a||
9288|020|U|deficiency may occur in certain health conditions (such as poor||
9288|021|U|nutrition, pregnancy, stomach/intestinal problems, infection,||
9288|022|U|cancer). Serious vitamin B12 deficiency may result in anemia,||
9288|023|U|stomach problems, and nerve damage.||
9288|024|B|||
9288|025|H|HOW TO USE:  Read the Patient Information Leaflet provided by||
9288|026|H|your pharmacist before you start using this medication and each||
9288|027|H|time you get a refill. Follow the illustrated directions for the||
9288|028|H|proper use of this medication. If you have any questions, ask||
9288|029|H|your doctor or pharmacist.||
9288|030|H|   Gently blow your nose before using this drug. If your product||
9288|031|H|needs to be primed, follow the instructions on how to properly||
9288|032|H|prime the bottle.||
9288|033|H|   Use this medication in the nose as directed by your doctor,||
9288|034|H|usually once weekly. Hot food or drinks may produce mucus that||
9288|035|H|can wash away this medication. Avoid hot food or drinks for 1||
9288|036|H|hour before or after using this medication.||
9288|037|H|   For products that contain more than 1 dose, keep track of the||
9288|038|H|number of doses you use from each pump.||
9288|039|H|   The dosage is based on your medical condition and response to||
9288|040|H|treatment. Do not increase, decrease, or stop this medication||
9288|041|H|without your doctor's approval. Use this medication regularly to||
9288|042|H|get the most benefit from it. To help you remember, use it on the||
9288|043|H|same day each week. Mark your calendar with a reminder.||
9288|044|B|||
9288|045|S|SIDE EFFECTS:  Headache, nausea, or runny nose may occur. If any||
9288|046|S|of these effects last or get worse, tell your doctor or||
9288|047|S|pharmacist promptly.||
9288|048|S|   Remember that this medication has been prescribed because your||
9288|049|S|doctor has judged that the benefit to you is greater than the||
9288|050|S|risk of side effects. Many people using this medication do not||
9288|051|S|have serious side effects.||
9288|052|S|   This medication may cause low potassium levels in the blood||
9288|053|S|(hypokalemia). Tell your doctor right away if any of these||
9288|054|S|serious side effects occur: muscle cramps, weakness, irregular||
9288|055|S|heartbeat.||
9288|056|S|   People who have a rare blood disorder (polycythemia vera) may||
9288|057|S|rarely have symptoms related to this disorder while taking||
9288|058|S|cyanocobalamin. Get medical help right away if any of these very||
9288|059|S|serious symptoms occur: chest pain (especially with shortness of||
9288|060|S|breath), weakness on one side of the body, sudden vision changes,||
9288|061|S|trouble speaking.||
9288|062|S|   A very serious allergic reaction to this drug is rare.||
9288|063|S|However, get medical help right away if you notice any symptoms||
9288|064|S|of a serious allergic reaction, including: rash, itching/swelling||
9288|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9288|066|S|breathing.||
9288|067|S|   This is not a complete list of possible side effects. If you||
9288|068|S|notice other effects not listed above, contact your doctor or||
9288|069|S|pharmacist.||
9288|070|S|   In the US -||
9288|071|S|   Call your doctor for medical advice about side effects. You||
9288|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9288|073|S|www.fda.gov/medwatch.||
9288|074|S|   In Canada - Call your doctor for medical advice about side||
9288|075|S|effects. You may report side effects to Health Canada at||
9288|076|S|1-866-234-2345.||
9288|077|B|||
9288|078|P|PRECAUTIONS:  Before using cyanocobalamin, tell your doctor or||
9288|079|P|pharmacist if you are allergic to it; or to cobalt; or if you||
9288|080|P|have any other allergies. Your doctor may recommend that you||
9288|081|P|receive a smaller test dose before starting your regular dose.||
9288|082|P|This product may contain inactive ingredients, which can cause||
9288|083|P|allergic reactions or other problems. Talk to your pharmacist for||
9288|084|P|more details.||
9288|085|P|   Before using this medication, tell your doctor or pharmacist||
9288|086|P|your medical history, especially of: low potassium blood levels||
9288|087|P|(hypokalemia), gout, a certain blood disorder (polycythemia||
9288|088|P|vera), a certain eye disease (Leber's disease), other||
9288|089|P|vitamin/mineral deficiencies (especially folic acid and iron).||
9288|090|P|   Tell your doctor if you develop a stuffy or runny nose (such||
9288|091|P|as due to a common cold or allergies) while using this||
9288|092|P|medication. You may need to use another form of vitamin B12 when||
9288|093|P|these symptoms are present.||
9288|094|P|   Before having surgery, tell your doctor or dentist about all||
9288|095|P|the products you use (including prescription drugs,||
9288|096|P|nonprescription drugs, and herbal products).||
9288|097|P|   During pregnancy, this medication should be used only when||
9288|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
9288|099|P|   Based on information from related drugs, this medication may||
9288|100|P|pass into breast milk. Consult your doctor before breastfeeding.||
9288|101|B|||
9288|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9288|103|I|medications work or increase your risk for serious side effects.||
9288|104|I|This document does not contain all possible drug interactions.||
9288|105|I|Keep a list of all the products you use (including||
9288|106|I|prescription/nonprescription drugs and herbal products) and share||
9288|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
9288|108|I|the dosage of any medicines without your doctor's approval.||
9288|109|B|||
9288|110|O|OVERDOSE:  Overdose with this medication is very unlikely.||
9288|111|O|However, if someone has overdosed and has serious symptoms such||
9288|112|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9288|113|O|poison control center right away. US residents can call||
9288|114|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9288|115|B|||
9288|116|N|NOTES:  Do not share this medication with others.||
9288|117|N|   Lab and/or medical tests (such as blood potassium levels,||
9288|118|N|complete blood count, hematocrit, vitamin B12 levels) should be||
9288|119|N|done while you are using this medication. Keep all medical and||
9288|120|N|lab appointments. Consult your doctor for more details.||
9288|121|N|   This product is not a substitute for a proper diet. Remember||
9288|122|N|that it is best to get your vitamins from healthy foods. Vitamin||
9288|123|N|B12 is commonly found in many foods from animals, especially||
9288|124|N|liver, kidney, fish and shellfish, meat, and dairy foods.||
9288|125|B|||
9288|126|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9288|127|D|If it is near the time of the next dose, skip the missed dose.||
9288|128|D|Use your next dose at the regular time. Do not double the dose to||
9288|129|D|catch up.||
9288|130|B|||
9288|131|R|STORAGE:  Store the pump upright at room temperature away from||
9288|132|R|light. Do not freeze. Discard the pump after you have used the||
9288|133|R|labeled number of doses on the product package. Keep all||
9288|134|R|medications away from children and pets.||
9288|135|R|   Do not flush medications down the toilet or pour them into a||
9288|136|R|drain unless instructed to do so. Properly discard this product||
9288|137|R|when it is expired or no longer needed. Consult your pharmacist||
9288|138|R|or local waste disposal company.||
9288|139|B|||
9288|140|A|Information last revised January 2025.||
9288|141|A|Copyright(c) 2025 First Databank, Inc.||
9288|142|B|||
9289|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9289|002|Z|does NOT have all possible information about this product. This||
9289|003|Z|information does not assure that this product is safe, effective,||
9289|004|Z|or appropriate for you. This information is not individual||
9289|005|Z|medical advice and does not substitute for the advice of your||
9289|006|Z|health care professional. Always ask your health care||
9289|007|Z|professional for complete information about this product and your||
9289|008|Z|specific health needs.||
9289|009|B|||
9289|010|T|CELECOXIB - ORAL||
9289|011|F|(SEL-e-KOX-ib)||
9289|012|B|||
9289|013|C|COMMON BRAND NAME(S): Celebrex||
9289|014|B|||
9289|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
9289|016|W|celecoxib) may rarely increase the risk of a heart attack or||
9289|017|W|stroke. This effect can happen at any time while taking this drug||
9289|018|W|but is more likely if you take it for a long time. The risk may||
9289|019|W|be greater in older adults or if you have heart disease or||
9289|020|W|increased risk for heart disease (for example, due to smoking,||
9289|021|W|family history of heart disease, or conditions such as high blood||
9289|022|W|pressure or diabetes). Do not take this drug right before or||
9289|023|W|after heart bypass surgery (CABG).||
9289|024|W|   Also, this drug may rarely cause serious (rarely fatal)||
9289|025|W|bleeding from the stomach or intestines. This effect can occur||
9289|026|W|without warning symptoms at any time while taking this drug.||
9289|027|W|Older adults may be at higher risk for this effect. (See also||
9289|028|W|Precautions and Drug Interactions sections.)||
9289|029|W|   Stop taking celecoxib and get medical help right away if you||
9289|030|W|notice any of the following rare but serious side effects:||
9289|031|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
9289|032|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
9289|033|W|shortness of breath, unusual sweating, confusion, weakness on one||
9289|034|W|side of the body, trouble speaking, sudden vision changes.||
9289|035|W|   Talk with your doctor or pharmacist about the risks and||
9289|036|W|benefits of treatment with this medication.||
9289|037|B|||
9289|038|U|USES:  See also Warning section.||
9289|039|U|   This medication is used to treat arthritis, acute pain, and||
9289|040|U|menstrual pain and discomfort. Celecoxib is a nonsteroidal||
9289|041|U|anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor.||
9289|042|U|It works by blocking your body's production of certain natural||
9289|043|U|substances that cause inflammation. This effect helps to decrease||
9289|044|U|swelling, pain, or fever.||
9289|045|U|   If you are treating a chronic condition such as arthritis, ask||
9289|046|U|your doctor about non-drug treatments and/or using other||
9289|047|U|medications to treat your pain.||
9289|048|B|||
9289|049|V|OTHER USES:  This section contains uses of this drug that are not||
9289|050|V|listed in the approved professional labeling for the drug but||
9289|051|V|that may be prescribed by your health care professional. Use this||
9289|052|V|drug for a condition that is listed in this section only if it||
9289|053|V|has been so prescribed by your health care professional.||
9289|054|V|   This drug may also be used for gout attacks.||
9289|055|B|||
9289|056|H|HOW TO USE:  Read the Medication Guide provided by your||
9289|057|H|pharmacist before you start using celecoxib and each time you get||
9289|058|H|a refill. If you have any questions, ask your doctor or||
9289|059|H|pharmacist.||
9289|060|H|   Take this medication by mouth as directed by your doctor,||
9289|061|H|usually once or twice daily. To decrease the chance of stomach||
9289|062|H|upset, this drug is best taken with food. Take this medication||
9289|063|H|with a full glass of water (8 ounces or 240 milliliters) unless||
9289|064|H|your doctor directs you otherwise. Do not lie down for at least||
9289|065|H|10 minutes after taking this medication.||
9289|066|H|   The dosage is based on your medical condition and response to||
9289|067|H|treatment. To reduce your risk of stomach bleeding and other side||
9289|068|H|effects, take this medication at the lowest effective dose for||
9289|069|H|the shortest possible time. Do not increase your dose or take||
9289|070|H|this drug more often or for longer than prescribed. For ongoing||
9289|071|H|conditions such as arthritis, keep taking this medication as||
9289|072|H|directed. Discuss the risks and benefits with your doctor or||
9289|073|H|pharmacist.||
9289|074|H|   For certain conditions (such as arthritis), it may take up to||
9289|075|H|two weeks of taking this drug regularly before you get the full||
9289|076|H|benefit.||
9289|077|H|   If you are taking this drug on an "as needed" basis (not on a||
9289|078|H|regular schedule), remember that pain medications work best if||
9289|079|H|they are used as the first signs of pain occur. If you wait until||
9289|080|H|the pain has worsened, the medication may not work as well.||
9289|081|H|   Tell your doctor if your condition lasts or gets worse.||
9289|082|B|||
9289|083|S|SIDE EFFECTS:  See also Warning section.||
9289|084|S|   Upset stomach or gas may occur. If either of these effects||
9289|085|S|lasts or gets worse, tell your doctor or pharmacist promptly.||
9289|086|S|   Remember that this medication has been prescribed because your||
9289|087|S|doctor has judged that the benefit to you is greater than the||
9289|088|S|risk of side effects. Many people using this medication do not||
9289|089|S|have serious side effects.||
9289|090|S|   This medication may raise your blood pressure. Check your||
9289|091|S|blood pressure regularly and tell your doctor if the results are||
9289|092|S|high.||
9289|093|S|   Tell your doctor right away if you have any serious side||
9289|094|S|effects, including: pain/swelling/warmth in the groin/calf, signs||
9289|095|S|of kidney problems (such as change in the amount of urine),||
9289|096|S|difficult/painful swallowing, symptoms of heart failure (such as||
9289|097|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
9289|098|S|gain).||
9289|099|S|   This drug may rarely cause serious (possibly fatal) liver||
9289|100|S|disease. Get medical help right away if you have any symptoms of||
9289|101|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
9289|102|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
9289|103|S|urine.||
9289|104|S|   A very serious allergic reaction to this drug is rare.||
9289|105|S|However, get medical help right away if you notice any symptoms||
9289|106|S|of a serious allergic reaction, including: fever, swollen lymph||
9289|107|S|nodes, rash, itching/swelling (especially of the||
9289|108|S|face/tongue/throat), severe dizziness, trouble breathing.||
9289|109|S|   This is not a complete list of possible side effects. If you||
9289|110|S|notice other effects not listed above, contact your doctor or||
9289|111|S|pharmacist.||
9289|112|S|   In the US -||
9289|113|S|   Call your doctor for medical advice about side effects. You||
9289|114|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9289|115|S|www.fda.gov/medwatch.||
9289|116|S|   In Canada - Call your doctor for medical advice about side||
9289|117|S|effects. You may report side effects to Health Canada at||
9289|118|S|1-866-234-2345.||
9289|119|B|||
9289|120|P|PRECAUTIONS:  See also Warning section.||
9289|121|P|   Before taking celecoxib, tell your doctor or pharmacist if you||
9289|122|P|are allergic to it; or to aspirin, or other NSAIDs (such as||
9289|123|P|ibuprofen, naproxen); or if you have any other allergies. This||
9289|124|P|product may contain inactive ingredients, which can cause||
9289|125|P|allergic reactions or other problems. Talk to your pharmacist for||
9289|126|P|more details.||
9289|127|P|   Before using this medication, tell your doctor or pharmacist||
9289|128|P|your medical history, especially of: asthma (including a history||
9289|129|P|of worsening breathing after taking aspirin or other NSAIDs),||
9289|130|P|bleeding/clotting problems, blood disorders (such as anemia),||
9289|131|P|growths in the nose (nasal polyps), heart disease (such as||
9289|132|P|previous heart attack), high blood pressure, liver disease,||
9289|133|P|stroke, swelling (edema, fluid retention),||
9289|134|P|stomach/intestine/esophagus problems (such as bleeding, ulcers,||
9289|135|P|recurring heartburn).||
9289|136|P|   Kidney problems can sometimes occur with the use of NSAID||
9289|137|P|medications, including celecoxib. Problems are more likely to||
9289|138|P|occur if you are dehydrated, have heart failure or kidney||
9289|139|P|disease, are an older adult, or if you take certain medications||
9289|140|P|(see also Drug Interactions section). Drink plenty of fluids as||
9289|141|P|directed by your doctor to prevent dehydration and tell your||
9289|142|P|doctor right away if you have a change in the amount of urine.||
9289|143|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
9289|144|P|and tobacco, especially when combined with this medicine, may||
9289|145|P|increase your risk for stomach bleeding. Limit alcohol and||
9289|146|P|smoking. Consult your doctor or pharmacist for more information.||
9289|147|P|   Before having surgery, tell your doctor or dentist about all||
9289|148|P|the products you use (including prescription drugs,||
9289|149|P|nonprescription drugs, and herbal products).||
9289|150|P|   Older adults may be at greater risk for stomach/intestinal||
9289|151|P|bleeding, kidney problems, heart attack, and stroke while using||
9289|152|P|this drug.||
9289|153|P|   Children with a certain type of arthritis (systemic onset||
9289|154|P|juvenile rheumatoid arthritis) may be at greater risk for a very||
9289|155|P|serious bleeding/clotting problem (disseminated intravascular||
9289|156|P|coagulation) while using this drug. Get medical help right away||
9289|157|P|if your child develops sudden bleeding/bruising or bluish skin in||
9289|158|P|the fingers/toes.||
9289|159|P|   Before using this medication, women of childbearing age should||
9289|160|P|talk with their doctor(s) about the benefits and risks. Tell your||
9289|161|P|doctor if you are pregnant or if you plan to become pregnant.||
9289|162|P|This medication may harm an unborn baby and cause problems with||
9289|163|P|normal labor/delivery. It is not recommended for use in pregnancy||
9289|164|P|from 20 weeks until delivery. If your doctor decides that you||
9289|165|P|need to use this medication between 20 and 30 weeks of pregnancy,||
9289|166|P|you should use the lowest effective dose for the shortest||
9289|167|P|possible time. You should not use this medication after 30 weeks||
9289|168|P|of pregnancy.||
9289|169|P|   This medication passes into breast milk. Consult your doctor||
9289|170|P|before breastfeeding.||
9289|171|B|||
9289|172|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9289|173|I|medications work or increase your risk for serious side effects.||
9289|174|I|This document does not contain all possible drug interactions.||
9289|175|I|Keep a list of all the products you use (including||
9289|176|I|prescription/nonprescription drugs and herbal products) and share||
9289|177|I|it with your doctor and pharmacist. Do not start, stop, or change||
9289|178|I|the dosage of any medicines without your doctor's approval.||
9289|179|I|   Some products that may interact with this drug include:||
9289|180|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
9289|181|I|angiotensin II receptor blockers (such as valsartan, losartan),||
9289|182|I|cidofovir, corticosteroids (such as dexamethasone, prednisone),||
9289|183|I|lithium, methotrexate, "water pills" (diuretics such as||
9289|184|I|furosemide).||
9289|185|I|   This medication may increase the risk of bleeding when taken||
9289|186|I|with other drugs that also may cause bleeding. Examples include||
9289|187|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
9289|188|I|dabigatran/enoxaparin/warfarin, among others.||
9289|189|I|   Check all prescription and nonprescription medicine labels||
9289|190|I|carefully since many medications contain pain relievers/fever||
9289|191|I|reducers (aspirin, NSAIDs such as naproxen, ibuprofen,||
9289|192|I|ketorolac). These drugs are similar to celecoxib and may increase||
9289|193|I|your risk of side effects if taken together. However, if your||
9289|194|I|doctor has told you to take low-dose aspirin to prevent heart||
9289|195|I|attack or stroke (usually 81-162 milligrams a day), you should||
9289|196|I|keep taking the aspirin unless your doctor tells you not to. Ask||
9289|197|I|your doctor or pharmacist for more details.||
9289|198|B|||
9289|199|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9289|200|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9289|201|O|poison control center right away. US residents can call||
9289|202|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9289|203|O|Symptoms of overdose may include: severe stomach pain,||
9289|204|O|slow/shallow breathing, or loss of consciousness.||
9289|205|B|||
9289|206|N|NOTES:  Do not share this medication with others.||
9289|207|N|   Lab and/or medical tests (such as blood pressure, complete||
9289|208|N|blood count, liver/kidney function) may be done while you are||
9289|209|N|taking this medication. Keep all medical and lab appointments.||
9289|210|N|Consult your doctor for more details.||
9289|211|N|   Lifestyle changes (such as weight loss if needed,||
9289|212|N|strengthening/conditioning exercises) may help improve your||
9289|213|N|flexibility and joint function. Consult your doctor for specific||
9289|214|N|instructions.||
9289|215|B|||
9289|216|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9289|217|D|remember. If it is near the time of the next dose, skip the||
9289|218|D|missed dose. Take your next dose at the regular time. Do not||
9289|219|D|double the dose to catch up.||
9289|220|B|||
9289|221|R|STORAGE:  Store at room temperature away from light and moisture.||
9289|222|R|Do not store in the bathroom. Keep all medications away from||
9289|223|R|children and pets.||
9289|224|R|   Do not flush medications down the toilet or pour them into a||
9289|225|R|drain unless instructed to do so. Properly discard this product||
9289|226|R|when it is expired or no longer needed. Consult your pharmacist||
9289|227|R|or local waste disposal company.||
9289|228|B|||
9289|229|A|Information last revised October 2025.||
9289|230|A|Copyright(c) 2025 First Databank, Inc.||
9289|231|B|||
9294|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9294|002|Z|does NOT have all possible information about this product. This||
9294|003|Z|information does not assure that this product is safe, effective,||
9294|004|Z|or appropriate for you. This information is not individual||
9294|005|Z|medical advice and does not substitute for the advice of your||
9294|006|Z|health care professional. Always ask your health care||
9294|007|Z|professional for complete information about this product and your||
9294|008|Z|specific health needs.||
9294|009|B|||
9294|010|T|EFAVIRENZ - ORAL||
9294|011|F|(eh-FAV-er-enz)||
9294|012|B|||
9294|013|C|COMMON BRAND NAME(S): Sustiva||
9294|014|B|||
9294|015|U|USES:  This drug is used with other HIV medications to help||
9294|016|U|control HIV infection. It helps to decrease the amount of HIV in||
9294|017|U|your body so your immune system can work better. This lowers your||
9294|018|U|chance of getting HIV complications (such as new infections,||
9294|019|U|cancer) and improves your quality of life. Efavirenz belongs to a||
9294|020|U|class of drugs known as non-nucleoside reverse transcriptase||
9294|021|U|inhibitors (NNRTIs).||
9294|022|U|   Efavirenz is not a cure for HIV infection. To decrease your||
9294|023|U|risk of spreading HIV disease to others, continue to take all HIV||
9294|024|U|medications exactly as prescribed by your doctor. Use an||
9294|025|U|effective barrier method (latex or polyurethane condoms/dental||
9294|026|U|dams) during sexual activity as directed by your doctor. Do not||
9294|027|U|share personal items (such as needles/syringes, toothbrushes, and||
9294|028|U|razors) that may have contacted blood or other body fluids.||
9294|029|U|Consult your doctor or pharmacist for more details.||
9294|030|B|||
9294|031|V|OTHER USES:  This section contains uses of this drug that are not||
9294|032|V|listed in the approved professional labeling for the drug but||
9294|033|V|that may be prescribed by your health care professional. Use this||
9294|034|V|drug for a condition that is listed in this section only if it||
9294|035|V|has been so prescribed by your health care professional.||
9294|036|V|   This product may also be used to lessen the risk of HIV||
9294|037|V|infection after contact with the virus (for example, due to a||
9294|038|V|needle stick). Ask your doctor for more details.||
9294|039|B|||
9294|040|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9294|041|H|from your pharmacist before you start taking efavirenz and each||
9294|042|H|time you get a refill. If you have any questions, ask your doctor||
9294|043|H|or pharmacist.||
9294|044|H|   Take this medication by mouth on an empty stomach as directed||
9294|045|H|by your doctor, usually once daily at bedtime. Taking efavirenz||
9294|046|H|with food increases the blood level of this medication, which may||
9294|047|H|increase your risk of certain side effects. See Side Effects||
9294|048|H|section.||
9294|049|H|   Swallow this medication whole with water. If you have||
9294|050|H|difficulty swallowing the capsule, it may be opened and the||
9294|051|H|contents mixed gently in a small amount (1 to 2 teaspoons) of||
9294|052|H|soft food such as applesauce, grape jelly, or yogurt. After||
9294|053|H|taking the mixed medication, add 2 more teaspoons of food to the||
9294|054|H|empty mixing container. Swallow the remaining mixture to make||
9294|055|H|sure that you get the entire dose. Swallow within 30 minutes of||
9294|056|H|mixing. Do not eat any food for 2 hours after taking this||
9294|057|H|medication. For babies who cannot eat solid foods, the contents||
9294|058|H|may be mixed in 2 teaspoons of infant formula and drawn up into||
9294|059|H|an oral syringe to be given to the baby. (See Patient Information||
9294|060|H|Leaflet.)||
9294|061|H|   The dosage is based on your medical condition, response to||
9294|062|H|treatment, and other medications you may be taking. Children's||
9294|063|H|dosage is also based on weight. Be sure to tell your doctor and||
9294|064|H|pharmacist about all the products you use (including prescription||
9294|065|H|drugs, nonprescription drugs, and herbal products).||
9294|066|H|   It is very important to keep taking this medication (and other||
9294|067|H|HIV medications) exactly as prescribed by your doctor. Do not||
9294|068|H|skip any doses. Do not increase your dose, take this drug more||
9294|069|H|often than prescribed, or stop taking it (or other HIV medicines)||
9294|070|H|even for a short time unless directed to do so by your doctor.||
9294|071|H|Skipping or changing your dose without approval from your doctor||
9294|072|H|may cause the amount of virus to increase, make the infection||
9294|073|H|more difficult to treat (resistant), or worsen side effects.||
9294|074|H|   For the best effect, take this medication at evenly spaced||
9294|075|H|times. To help you remember, take this medication at the same||
9294|076|H|time every day.||
9294|077|B|||
9294|078|S|SIDE EFFECTS:  Dizziness, trouble sleeping, drowsiness, unusual||
9294|079|S|dreams, and trouble concentrating may often occur. These side||
9294|080|S|effects may begin 1-2 days after starting this medication and||
9294|081|S|usually go away in 2-4 weeks. They are also reduced by taking||
9294|082|S|efavirenz on an empty stomach at bedtime. Avoid alcohol and||
9294|083|S|street drugs while taking efavirenz. They may worsen these side||
9294|084|S|effects.||
9294|085|S|   Tiredness, headache, nausea, vomiting, and diarrhea may also||
9294|086|S|occur.||
9294|087|S|   If any of these effects last or get worse, tell your doctor or||
9294|088|S|pharmacist promptly.||
9294|089|S|   Remember that this medication has been prescribed because your||
9294|090|S|doctor has judged that the benefit to you is greater than the||
9294|091|S|risk of side effects. Many people using this medication do not||
9294|092|S|have serious side effects.||
9294|093|S|   As your immune system gets stronger, it can begin to fight off||
9294|094|S|infections you already had, possibly causing disease symptoms to||
9294|095|S|come back. You could also have symptoms if your immune system||
9294|096|S|becomes overactive. This reaction may happen at any time (soon||
9294|097|S|after starting HIV treatment or many months later). Tell your||
9294|098|S|doctor right away if you have any serious symptoms, including:||
9294|099|S|unexplained weight loss, severe tiredness, muscle aches/weakness||
9294|100|S|that doesn't go away, headaches that are severe or don't go away,||
9294|101|S|joint pain, numbness/tingling of the hands/feet/arms/legs, vision||
9294|102|S|changes, signs of infection (such as sore throat that doesn't go||
9294|103|S|away, fever, chills, swollen lymph nodes, non-healing skin||
9294|104|S|sores), signs of an overactive thyroid (such as irritability,||
9294|105|S|nervousness, heat intolerance, fast/pounding/irregular||
9294|106|S|heartbeat).||
9294|107|S|   Tell your doctor right away if you have any serious side||
9294|108|S|effects, including: signs of liver problems (such as||
9294|109|S|nausea/vomiting that doesn't stop, stomach/abdominal pain, severe||
9294|110|S|tiredness, yellowing eyes/skin, dark urine), mental/mood changes||
9294|111|S|(such as depression, rare thoughts of suicide, nervousness, angry||
9294|112|S|behavior, hallucinations, confusion), loss of coordination.||
9294|113|S|   Changes in body fat may occur while you are taking this||
9294|114|S|medication (such as increased fat in the upper back and stomach||
9294|115|S|areas, decreased fat in the arms and legs). The cause and||
9294|116|S|long-term effects of these changes are unknown. Discuss the risks||
9294|117|S|and benefits of treatment with your doctor, as well as the||
9294|118|S|possible use of exercise to reduce this side effect.||
9294|119|S|   Get medical help right away if you have any very serious side||
9294|120|S|effects, including: fast/irregular heartbeat, severe dizziness,||
9294|121|S|fainting.||
9294|122|S|   Efavirenz can commonly cause a rash that is usually not||
9294|123|S|serious. In adults, a rash may occur in the first 2 weeks after||
9294|124|S|starting treatment and if it is not serious, it will usually||
9294|125|S|resolve in 4 weeks. In children, a rash may occur in the first 4||
9294|126|S|weeks after starting treatment. However, you may not be able to||
9294|127|S|tell it apart from a rare rash that could be a sign of a severe||
9294|128|S|reaction. Get medical help right away if you develop any rash.||
9294|129|S|   A very serious allergic reaction to this drug is rare.||
9294|130|S|However, get medical help right away if you notice any symptoms||
9294|131|S|of a serious allergic reaction, including: rash, blisters,||
9294|132|S|peeling skin, fever, itching/swelling (especially of the||
9294|133|S|face/tongue/throat), severe dizziness, trouble breathing.||
9294|134|S|   This is not a complete list of possible side effects. If you||
9294|135|S|notice other effects not listed above, contact your doctor or||
9294|136|S|pharmacist.||
9294|137|S|   In the US -||
9294|138|S|   Call your doctor for medical advice about side effects. You||
9294|139|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9294|140|S|www.fda.gov/medwatch.||
9294|141|S|   In Canada - Call your doctor for medical advice about side||
9294|142|S|effects. You may report side effects to Health Canada at||
9294|143|S|1-866-234-2345.||
9294|144|B|||
9294|145|P|PRECAUTIONS:  Before taking efavirenz, tell your doctor or||
9294|146|P|pharmacist if you are allergic to it; or if you have any other||
9294|147|P|allergies. This product may contain inactive ingredients, which||
9294|148|P|can cause allergic reactions or other problems. Talk to your||
9294|149|P|pharmacist for more details.||
9294|150|P|   Before using this medication, tell your doctor or pharmacist||
9294|151|P|your medical history, especially of: mental/mood conditions (such||
9294|152|P|as depression, thoughts of suicide, psychosis), liver problems||
9294|153|P|(such as hepatitis B or C, cirrhosis), drug/substance/alcohol||
9294|154|P|abuse, seizures, high cholesterol/triglyceride levels.||
9294|155|P|   Efavirenz may cause a condition that affects the heart rhythm||
9294|156|P|(QT prolongation). QT prolongation can rarely cause serious||
9294|157|P|(rarely fatal) fast/irregular heartbeat and other symptoms (such||
9294|158|P|as severe dizziness, fainting) that need medical attention right||
9294|159|P|away.||
9294|160|P|   The risk of QT prolongation may be increased if you have||
9294|161|P|certain medical conditions or are taking other drugs that may||
9294|162|P|cause QT prolongation. Before using efavirenz, tell your doctor||
9294|163|P|or pharmacist of all the drugs you take and if you have any of||
9294|164|P|the following conditions: certain heart problems (heart failure,||
9294|165|P|slow heartbeat, QT prolongation in the EKG), family history of||
9294|166|P|certain heart problems (QT prolongation in the EKG, sudden||
9294|167|P|cardiac death).||
9294|168|P|   Low levels of potassium or magnesium in the blood may also||
9294|169|P|increase your risk of QT prolongation. This risk may increase if||
9294|170|P|you use certain drugs (such as diuretics "water pills") or if you||
9294|171|P|have conditions such as severe sweating, diarrhea, or vomiting.||
9294|172|P|Talk to your doctor about using efavirenz safely.||
9294|173|P|   This drug may make you dizzy or drowsy or cause trouble||
9294|174|P|concentrating. Alcohol or marijuana (cannabis) can worsen these||
9294|175|P|effects. Do not drive, use machinery, or do anything that needs||
9294|176|P|alertness until you can do it safely. Avoid alcoholic beverages.||
9294|177|P|Talk to your doctor if you are using marijuana (cannabis).||
9294|178|P|   Before having surgery, tell your doctor or dentist about all||
9294|179|P|the products you use (including prescription drugs,||
9294|180|P|nonprescription drugs, and herbal products).||
9294|181|P|   A rash may be more common and serious in children taking||
9294|182|P|efavirenz. Report any rash right away. The doctor may prescribe||
9294|183|P|an antihistamine for your child to take before efavirenz is||
9294|184|P|started. Consult the doctor for more information.||
9294|185|P|   Older adults may be more sensitive to the side effects of this||
9294|186|P|drug, especially QT prolongation (see above).||
9294|187|P|   During pregnancy, this medication should be used only when||
9294|188|P|clearly needed. Treatment can lower the risk of passing HIV||
9294|189|P|infection to your baby, and efavirenz may be part of that||
9294|190|P|treatment. Discuss the risks and benefits with your doctor.||
9294|191|P|   This medication passes into breast milk. Because breast milk||
9294|192|P|may transmit HIV, consult your doctor before breastfeeding.||
9294|193|B|||
9294|194|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9294|195|I|medications work or increase your risk for serious side effects.||
9294|196|I|This document does not contain all possible drug interactions.||
9294|197|I|Keep a list of all the products you use (including||
9294|198|I|prescription/nonprescription drugs and herbal products) and share||
9294|199|I|it with your doctor and pharmacist. Do not start, stop, or change||
9294|200|I|the dosage of any medicines without your doctor's approval.||
9294|201|I|   A product that may interact with this drug is: orlistat.||
9294|202|I|   Do not take this medication with other products that contain||
9294|203|I|efavirenz unless specifically directed by your doctor.||
9294|204|I|   Other medications can affect the removal of efavirenz from||
9294|205|I|your body, which may affect how efavirenz works. Examples include||
9294|206|I|some drugs used to treat seizures (such as carbamazepine,||
9294|207|I|phenobarbital, phenytoin), among others.||
9294|208|I|   Efavirenz can speed up the removal of many other medications||
9294|209|I|from your body, which may affect how they work. Examples of||
9294|210|I|affected drugs include atovaquone/proguanil, azole antifungals||
9294|211|I|(such as itraconazole, ketoconazole), bedaquiline, cobicistat,||
9294|212|I|elbasvir/grazoprevir, macrolide antibiotics (such as||
9294|213|I|clarithromycin), methadone, rifabutin, sertraline, some||
9294|214|I|cholesterol-lowering statins (such as atorvastatin, pravastatin,||
9294|215|I|simvastatin), warfarin, among others.||
9294|216|I|   Some other drugs to treat HIV infection (such as elvitegravir,||
9294|217|I|other NNRTIs including etravirine/nevirapine/rilpivirine) may||
9294|218|I|also interact with efavirenz. If you are taking atazanavir with||
9294|219|I|this medication, you may need to also take another medication||
9294|220|I|(ritonavir). Consult your doctor or pharmacist for more details.||
9294|221|I|   This medication may decrease the effectiveness of hormonal||
9294|222|I|birth control such as pills, patch, or ring. This could cause||
9294|223|I|pregnancy. Discuss with your doctor or pharmacist if you should||
9294|224|I|use reliable backup birth control methods while using this||
9294|225|I|medication. Also tell your doctor if you have any new spotting or||
9294|226|I|breakthrough bleeding, because these may be signs that your birth||
9294|227|I|control is not working well.||
9294|228|I|   Tell your doctor or pharmacist if you are taking other||
9294|229|I|products that cause drowsiness including alcohol, marijuana||
9294|230|I|(cannabis), antihistamines (such as cetirizine, diphenhydramine),||
9294|231|I|drugs for sleep or anxiety (such as diazepam, zolpidem), muscle||
9294|232|I|relaxants, and opioid pain relievers (such as codeine).||
9294|233|I|   Check the labels on all your medicines (such as allergy or||
9294|234|I|cough-and-cold products) because they may contain ingredients||
9294|235|I|that cause drowsiness. Ask your pharmacist about using those||
9294|236|I|products safely.||
9294|237|I|   This medication may interfere with certain lab tests (such as||
9294|238|I|urine cannabinoid tests), possibly causing false test results.||
9294|239|I|Make sure lab personnel and all your doctors know you use this||
9294|240|I|drug.||
9294|241|B|||
9294|242|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9294|243|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9294|244|O|poison control center right away. US residents can call||
9294|245|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9294|246|B|||
9294|247|N|NOTES:  Do not share this medication with others.||
9294|248|N|   Lab and/or medical tests (such as liver tests, viral load,||
9294|249|N|T-cell counts, cholesterol and triglyceride levels) should be||
9294|250|N|done before you start taking this medication and while you are||
9294|251|N|taking it. Keep all medical and lab appointments. Consult your||
9294|252|N|doctor for more details.||
9294|253|B|||
9294|254|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9294|255|D|remember. If it is near the time of the next dose, skip the||
9294|256|D|missed dose. Take your next dose at the regular time. Do not||
9294|257|D|double the dose to catch up.||
9294|258|B|||
9294|259|R|STORAGE:  Store at room temperature away from light and moisture.||
9294|260|R|Do not store in the bathroom. Keep all medications away from||
9294|261|R|children and pets.||
9294|262|R|   Do not flush medications down the toilet or pour them into a||
9294|263|R|drain unless instructed to do so. Properly discard this product||
9294|264|R|when it is expired or no longer needed. Consult your pharmacist||
9294|265|R|or local waste disposal company.||
9294|266|B|||
9294|267|A|Information last revised April 2025.||
9294|268|A|Copyright(c) 2025 First Databank, Inc.||
9294|269|B|||
9295|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9295|002|Z|does NOT have all possible information about this product. This||
9295|003|Z|information does not assure that this product is safe, effective,||
9295|004|Z|or appropriate for you. This information is not individual||
9295|005|Z|medical advice and does not substitute for the advice of your||
9295|006|Z|health care professional. Always ask your health care||
9295|007|Z|professional for complete information about this product and your||
9295|008|Z|specific health needs.||
9295|009|B|||
9295|010|T|AMOXICILLIN CHEWABLE TABLET - ORAL||
9295|011|F|(a-MOX-i-SIL-in)||
9295|012|B|||
9295|013|C|COMMON BRAND NAME(S): Amoxil||
9295|014|B|||
9295|015|U|USES:  Amoxicillin is used to treat a wide variety of bacterial||
9295|016|U|infections. This medication is a penicillin-type antibiotic. It||
9295|017|U|works by stopping the growth of bacteria.||
9295|018|U|   This antibiotic treats only bacterial infections. It will not||
9295|019|U|work for viral infections (such as common cold, flu). Using any||
9295|020|U|antibiotic when it is not needed can cause it to not work for||
9295|021|U|future infections.||
9295|022|U|   Amoxicillin is also used with other medications to treat||
9295|023|U|stomach/intestinal ulcers caused by the bacteria H. pylori and to||
9295|024|U|prevent the ulcers from returning.||
9295|025|B|||
9295|026|H|HOW TO USE:  Chew the tablets thoroughly and swallow, followed by||
9295|027|H|a full glass of water (8 ounces or 240 milliliters). Take this||
9295|028|H|medication with or without food as directed by your doctor,||
9295|029|H|usually every 8 or 12 hours. The dosage is based on your medical||
9295|030|H|condition and response to treatment.||
9295|031|H|   Drink plenty of fluids while using this medication unless your||
9295|032|H|doctor tells you otherwise.||
9295|033|H|   For the best effect, take this antibiotic at evenly spaced||
9295|034|H|times. To help you remember, take this medication at the same||
9295|035|H|time(s) every day.||
9295|036|H|   Continue to take this medication until the full prescribed||
9295|037|H|amount is finished, even if symptoms disappear after a few days.||
9295|038|H|Stopping the medication too early may result in a return of the||
9295|039|H|infection.||
9295|040|H|   Tell your doctor if your condition lasts or gets worse.||
9295|041|B|||
9295|042|S|SIDE EFFECTS:  Nausea, vomiting, or diarrhea may occur. If any of||
9295|043|S|these effects last or get worse, tell your doctor or pharmacist||
9295|044|S|promptly.||
9295|045|S|   This medicine may cause temporary staining of the teeth.||
9295|046|S|Proper brushing will usually remove any stains and may prevent||
9295|047|S|them from occurring.||
9295|048|S|   Remember that this medication has been prescribed because your||
9295|049|S|doctor has judged that the benefit to you is greater than the||
9295|050|S|risk of side effects. Many people using this medication do not||
9295|051|S|have serious side effects.||
9295|052|S|   Use of this medication for prolonged or repeated periods may||
9295|053|S|result in oral thrush or a new vaginal yeast infection (oral or||
9295|054|S|vaginal fungal infection). Contact your doctor if you notice||
9295|055|S|white patches in your mouth, a change in vaginal discharge or||
9295|056|S|other new symptoms.||
9295|057|S|   Tell your doctor right away if you have any serious side||
9295|058|S|effects, including: signs of liver disease (such as||
9295|059|S|nausea/vomiting that doesn't stop, loss of appetite,||
9295|060|S|stomach/abdominal pain, yellowing eyes/skin, dark urine), easy||
9295|061|S|bruising or bleeding.||
9295|062|S|   This medication may rarely cause a severe intestinal condition||
9295|063|S|due to a bacteria called C. difficile. This condition may occur||
9295|064|S|during treatment or weeks to months after treatment has stopped.||
9295|065|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9295|066|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9295|067|S|stool.||
9295|068|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9295|069|S|products because they may make symptoms worse.||
9295|070|S|   A very serious allergic reaction to this drug is rare.||
9295|071|S|However, get medical help right away if you notice any symptoms||
9295|072|S|of a serious allergic reaction, including: fever that doesn't go||
9295|073|S|away, new or worsening lymph node swelling, rash,||
9295|074|S|itching/swelling (especially of the face/tongue/throat), severe||
9295|075|S|dizziness, trouble breathing.||
9295|076|S|   Amoxicillin can commonly cause a mild rash that is usually not||
9295|077|S|serious. However, you may not be able to tell it apart from a||
9295|078|S|rare rash that could be a sign of a severe allergic reaction. Get||
9295|079|S|medical help right away if you develop any rash.||
9295|080|S|   This is not a complete list of possible side effects. If you||
9295|081|S|notice other effects not listed above, contact your doctor or||
9295|082|S|pharmacist.||
9295|083|S|   In the US -||
9295|084|S|   Call your doctor for medical advice about side effects. You||
9295|085|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9295|086|S|www.fda.gov/medwatch.||
9295|087|S|   In Canada - Call your doctor for medical advice about side||
9295|088|S|effects. You may report side effects to Health Canada at||
9295|089|S|1-866-234-2345.||
9295|090|B|||
9295|091|P|PRECAUTIONS:  Before taking amoxicillin, tell your doctor or||
9295|092|P|pharmacist if you are allergic to it; or to penicillin or||
9295|093|P|cephalosporin antibiotics; or if you have any other allergies.||
9295|094|P|This product may contain inactive ingredients, which can cause||
9295|095|P|allergic reactions or other problems. Talk to your pharmacist for||
9295|096|P|more details.||
9295|097|P|   Before using this medication, tell your doctor or pharmacist||
9295|098|P|your medical history, especially of: kidney disease, a certain||
9295|099|P|type of viral infection (infectious mononucleosis).||
9295|100|P|   This medication may contain aspartame. If you have||
9295|101|P|phenylketonuria (PKU) or any other condition that requires you to||
9295|102|P|limit/avoid aspartame (or phenylalanine) in your diet, ask your||
9295|103|P|doctor or pharmacist about using this medication safely.||
9295|104|P|   Amoxicillin may cause live bacterial vaccines (such as typhoid||
9295|105|P|vaccine) to not work well. Tell your health care professional||
9295|106|P|that you are using amoxicillin before having any||
9295|107|P|immunizations/vaccinations.||
9295|108|P|   Before having surgery, tell your doctor or dentist about all||
9295|109|P|the products you use (including prescription drugs,||
9295|110|P|nonprescription drugs, and herbal products).||
9295|111|P|   During pregnancy, this medication should be used only when||
9295|112|P|clearly needed. Discuss the risks and benefits with your doctor.||
9295|113|P|   Amoxicillin passes into breast milk. Consult your doctor||
9295|114|P|before breastfeeding.||
9295|115|B|||
9295|116|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9295|117|I|medications work or increase your risk for serious side effects.||
9295|118|I|This document does not contain all possible drug interactions.||
9295|119|I|Keep a list of all the products you use (including||
9295|120|I|prescription/nonprescription drugs and herbal products) and share||
9295|121|I|it with your doctor and pharmacist. Do not start, stop, or change||
9295|122|I|the dosage of any medicines without your doctor's approval.||
9295|123|I|   A product that may interact with this drug is: methotrexate.||
9295|124|I|   This medication may interfere with certain lab tests (such as||
9295|125|I|certain diabetic urine tests), possibly causing false test||
9295|126|I|results. Make sure lab personnel and all your doctors know you||
9295|127|I|use this drug.||
9295|128|B|||
9295|129|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9295|130|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9295|131|O|poison control center right away. US residents can call||
9295|132|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9295|133|O|Symptoms of overdose may include: diarrhea that doesn't stop,||
9295|134|O|severe vomiting, a severe decrease in the amount of urine, or||
9295|135|O|seizures.||
9295|136|B|||
9295|137|N|NOTES:  Do not share this medication with others.||
9295|138|N|   This medication has been prescribed for your current condition||
9295|139|N|only. Do not use it later for another infection unless your||
9295|140|N|doctor tells you to.||
9295|141|N|   With prolonged treatment, lab and/or medical tests (such as||
9295|142|N|kidney/liver function, complete blood counts) may be done while||
9295|143|N|you are taking this medication. Keep all medical and lab||
9295|144|N|appointments. Consult your doctor for more details.||
9295|145|B|||
9295|146|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9295|147|D|If it is near the time of the next dose, skip the missed dose.||
9295|148|D|Use your next dose at the regular time. Do not double the dose to||
9295|149|D|catch up.||
9295|150|B|||
9295|151|R|STORAGE:  Store at room temperature away from light and moisture.||
9295|152|R|Do not store in the bathroom. Keep all medications away from||
9295|153|R|children and pets.||
9295|154|R|   Do not flush medications down the toilet or pour them into a||
9295|155|R|drain unless instructed to do so. Properly discard this product||
9295|156|R|when it is expired or no longer needed. Consult your pharmacist||
9295|157|R|or local waste disposal company.||
9295|158|B|||
9295|159|A|Information last revised May 2024.||
9295|160|A|Copyright(c) 2025 First Databank, Inc.||
9295|161|B|||
9297|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9297|002|Z|does NOT have all possible information about this product. This||
9297|003|Z|information does not assure that this product is safe, effective,||
9297|004|Z|or appropriate for you. This information is not individual||
9297|005|Z|medical advice and does not substitute for the advice of your||
9297|006|Z|health care professional. Always ask your health care||
9297|007|Z|professional for complete information about this product and your||
9297|008|Z|specific health needs.||
9297|009|B|||
9297|010|T|VARDENAFIL - ORAL||
9297|011|F|(var-DEN-a-fil)||
9297|012|B|||
9297|013|C|COMMON BRAND NAME(S): Levitra||
9297|014|B|||
9297|015|U|USES:  Vardenafil is used to treat male sexual function problems||
9297|016|U|(impotence or erectile dysfunction-ED). In combination with||
9297|017|U|sexual stimulation, vardenafil works by increasing blood flow to||
9297|018|U|the penis to help a man get and keep an erection.||
9297|019|U|   This drug does not protect against sexually transmitted||
9297|020|U|diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Using||
9297|021|U|an effective barrier method (latex or polyurethane condom/dental||
9297|022|U|dams) during sexual activity will help to decrease your risk of||
9297|023|U|infection.||
9297|024|B|||
9297|025|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9297|026|H|from your pharmacist before you start taking vardenafil and each||
9297|027|H|time you get a refill. If you have any questions, ask your doctor||
9297|028|H|or pharmacist.||
9297|029|H|   Take this medication by mouth as directed by your doctor,||
9297|030|H|usually as needed. Take vardenafil, with or without food, about 1||
9297|031|H|hour before sexual activity. Do not take more than once daily.||
9297|032|H|Doses should be taken at least 24 hours apart.||
9297|033|H|   The dosage is based on your medical condition, response to||
9297|034|H|treatment, and other medications you may be taking. Be sure to||
9297|035|H|tell your doctor and pharmacist about all the products you use||
9297|036|H|(including prescription drugs, nonprescription drugs, and herbal||
9297|037|H|products).||
9297|038|H|   Avoid eating grapefruit or drinking grapefruit juice while||
9297|039|H|using this medication unless your doctor or pharmacist says you||
9297|040|H|may do so safely. Grapefruit can increase the chance of side||
9297|041|H|effects with this medicine. Ask your doctor or pharmacist for||
9297|042|H|more details.||
9297|043|H|   Tell your doctor if your condition does not get better.||
9297|044|B|||
9297|045|S|SIDE EFFECTS:  Headache, flushing, stuffy/runny nose, or||
9297|046|S|dizziness may occur. Vision changes such as increased sensitivity||
9297|047|S|to light, blurred vision, or trouble telling blue and green||
9297|048|S|colors apart may also occur. If any of these effects last or get||
9297|049|S|worse, tell your doctor or pharmacist promptly.||
9297|050|S|   To reduce the risk of dizziness and lightheadedness, get up||
9297|051|S|slowly when rising from a sitting or lying position.||
9297|052|S|   Remember that this medication has been prescribed because your||
9297|053|S|doctor has judged that the benefit to you is greater than the||
9297|054|S|risk of side effects. Many people using this medication do not||
9297|055|S|have serious side effects.||
9297|056|S|   Sexual activity may put extra strain on your heart, especially||
9297|057|S|if you have heart problems. If you have heart problems and||
9297|058|S|experience any of these serious side effects while having sex,||
9297|059|S|stop and get medical help right away: severe dizziness, fainting,||
9297|060|S|chest/jaw/left arm pain, nausea.||
9297|061|S|   Rarely, sudden decreased vision, including permanent||
9297|062|S|blindness, in one or both eyes (NAION) may occur. If this serious||
9297|063|S|problem occurs, stop taking vardenafil and get medical help right||
9297|064|S|away. You have a slightly greater chance of developing NAION if||
9297|065|S|you have heart disease, diabetes, high cholesterol, certain other||
9297|066|S|eye problems ("crowded disk"), high blood pressure, if you are||
9297|067|S|over 50, or if you smoke.||
9297|068|S|   Rarely, a sudden decrease or loss of hearing, sometimes with||
9297|069|S|ringing in the ears and dizziness, may occur. Stop taking||
9297|070|S|vardenafil and get medical help right away if these effects||
9297|071|S|occur.||
9297|072|S|   In the rare event you have a painful or prolonged erection||
9297|073|S|lasting 4 or more hours, stop using this drug and get medical||
9297|074|S|help right away, or permanent problems could occur.||
9297|075|S|   Get medical help right away if you have any very serious side||
9297|076|S|effects, including: seizures, temporary memory loss.||
9297|077|S|   A very serious allergic reaction to this drug is rare.||
9297|078|S|However, get medical help right away if you notice any symptoms||
9297|079|S|of a serious allergic reaction, including: rash, itching/swelling||
9297|080|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9297|081|S|breathing.||
9297|082|S|   This is not a complete list of possible side effects. If you||
9297|083|S|notice other effects not listed above, contact your doctor or||
9297|084|S|pharmacist.||
9297|085|S|   In the US -||
9297|086|S|   Call your doctor for medical advice about side effects. You||
9297|087|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9297|088|S|www.fda.gov/medwatch.||
9297|089|S|   In Canada - Call your doctor for medical advice about side||
9297|090|S|effects. You may report side effects to Health Canada at||
9297|091|S|1-866-234-2345.||
9297|092|B|||
9297|093|P|PRECAUTIONS:  Before taking vardenafil, tell your doctor or||
9297|094|P|pharmacist if you are allergic to it; or if you have any other||
9297|095|P|allergies. This product may contain inactive ingredients, which||
9297|096|P|can cause allergic reactions or other problems. Talk to your||
9297|097|P|pharmacist for more details.||
9297|098|P|   Before using this medication, tell your doctor or pharmacist||
9297|099|P|your medical history, especially of: heart problems (such as||
9297|100|P|heart attack or life-threatening irregular heartbeat in the past||
9297|101|P|6 months, chest pain/angina, heart failure), stroke in the past 6||
9297|102|P|months, kidney disease (dialysis), liver disease, high or low||
9297|103|P|blood pressure, dehydration, penis conditions (such as||
9297|104|P|angulation, fibrosis/scarring, Peyronie's disease), history of||
9297|105|P|painful/prolonged erection (priapism), conditions that may||
9297|106|P|increase the risk of priapism (such as sickle cell anemia,||
9297|107|P|leukemia, multiple myeloma), eye problems (such as retinitis||
9297|108|P|pigmentosa, sudden decreased vision, NAION), bleeding disorders,||
9297|109|P|active stomach ulcers.||
9297|110|P|   This drug may make you dizzy or cause vision changes. Alcohol||
9297|111|P|or marijuana (cannabis) can make you more dizzy. Do not drive,||
9297|112|P|use machinery, or do anything that needs alertness or clear||
9297|113|P|vision until you can do it safely. Limit alcoholic beverages.||
9297|114|P|Talk to your doctor if you are using marijuana (cannabis).||
9297|115|P|   Before having surgery, tell your doctor or dentist about all||
9297|116|P|the products you use (including prescription drugs,||
9297|117|P|nonprescription drugs, and herbal products).||
9297|118|P|   This medication is not usually used in women. It is unlikely||
9297|119|P|to be used during pregnancy or breastfeeding. Consult your doctor||
9297|120|P|if you have any questions about this medication.||
9297|121|B|||
9297|122|I|DRUG INTERACTIONS:  See also How to Use section.||
9297|123|I|   Drug interactions may change how your medications work or||
9297|124|I|increase your risk for serious side effects. This document does||
9297|125|I|not contain all possible drug interactions. Keep a list of all||
9297|126|I|the products you use (including prescription/nonprescription||
9297|127|I|drugs and herbal products) and share it with your doctor and||
9297|128|I|pharmacist. Do not start, stop, or change the dosage of any||
9297|129|I|medicines without your doctor's approval.||
9297|130|I|   Some products that may interact with this drug are: riociguat,||
9297|131|I|vericiguat.||
9297|132|I|   Vardenafil can cause a serious drop in your blood pressure||
9297|133|I|when used with nitrates, which can lead to dizziness, fainting,||
9297|134|I|and rarely heart attack or stroke. Do not use vardenafil with any||
9297|135|I|of the following: certain drugs used to treat chest pain/angina||
9297|136|I|(nitrates such as nitroglycerin, isosorbide), recreational drugs||
9297|137|I|called "poppers" containing amyl or butyl nitrite.||
9297|138|I|   If you are also taking an alpha blocker medication (such as||
9297|139|I|doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high||
9297|140|I|blood pressure, your blood pressure may get too low which can||
9297|141|I|lead to dizziness or fainting. Your doctor may start treatment||
9297|142|I|with a lower dose of vardenafil to minimize your risk of low||
9297|143|I|blood pressure.||
9297|144|I|   Other medications can affect the removal of vardenafil from||
9297|145|I|your body, which may affect how vardenafil works. Examples||
9297|146|I|include azole antifungals (such as itraconazole, ketoconazole),||
9297|147|I|macrolide antibiotics (such as clarithromycin, erythromycin),||
9297|148|I|ritonavir, among others.||
9297|149|I|   Do not take this medication with any other product that||
9297|150|I|contains vardenafil or other similar medications used to treat||
9297|151|I|erectile dysfunction-ED or pulmonary hypertension (such as||
9297|152|I|sildenafil, tadalafil).||
9297|153|B|||
9297|154|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9297|155|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9297|156|O|poison control center right away. US residents can call||
9297|157|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9297|158|O|Symptoms of overdose may include: back/muscle pain, abnormal||
9297|159|O|vision.||
9297|160|B|||
9297|161|N|NOTES:  Do not share this medication with others.||
9297|162|B|||
9297|163|D|MISSED DOSE:  Not applicable.||
9297|164|B|||
9297|165|R|STORAGE:  Store at room temperature away from light and moisture.||
9297|166|R|Do not store in the bathroom. Keep all medications away from||
9297|167|R|children and pets.||
9297|168|R|   Do not flush medications down the toilet or pour them into a||
9297|169|R|drain unless instructed to do so. Properly discard this product||
9297|170|R|when it is expired or no longer needed. Consult your pharmacist||
9297|171|R|or local waste disposal company.||
9297|172|B|||
9297|173|A|Information last revised October 2025.||
9297|174|A|Copyright(c) 2025 First Databank, Inc.||
9297|175|B|||
9299|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9299|002|Z|does NOT have all possible information about this product. This||
9299|003|Z|information does not assure that this product is safe, effective,||
9299|004|Z|or appropriate for you. This information is not individual||
9299|005|Z|medical advice and does not substitute for the advice of your||
9299|006|Z|health care professional. Always ask your health care||
9299|007|Z|professional for complete information about this product and your||
9299|008|Z|specific health needs.||
9299|009|B|||
9299|010|T|ADALIMUMAB - INJECTION||
9299|011|F|(AY-da-LIM-ue-mab)||
9299|012|B|||
9299|013|C|COMMON BRAND NAME(S): Abrilada, Amjevita, Cyltezo, Hadlima,||
9299|014|C|Hulio, Humira, Hyrimoz, Idacio, Simlandi, Yuflyma, Yusimry||
9299|015|B|||
9299|016|W|WARNING:  This medication can decrease your body's ability to||
9299|017|W|fight an infection. This effect can lead to very serious||
9299|018|W|(possibly fatal) infections (such as fungal infections, bacterial||
9299|019|W|infections including tuberculosis). Tell your doctor your medical||
9299|020|W|history, especially of past/recent/current infections. You should||
9299|021|W|also tell your doctor if you have lived or traveled in areas||
9299|022|W|where certain fungal infections (such as coccidioidomycosis,||
9299|023|W|histoplasmosis) are common or if you have been near someone with||
9299|024|W|tuberculosis. Areas where these types of fungal infections are||
9299|025|W|commonly found include the Ohio and Mississippi River valleys and||
9299|026|W|the southwestern United States. Tell your doctor right away if||
9299|027|W|you develop signs of infection (see Side Effects section).||
9299|028|W|   Your doctor will test you for tuberculosis (TB) infection||
9299|029|W|before and during treatment with this drug. If you are diagnosed||
9299|030|W|with TB, your doctor will first prescribe treatment for this to||
9299|031|W|prevent a serious TB infection while using adalimumab.||
9299|032|W|   Though it is very unlikely to happen, there is a risk||
9299|033|W|(especially in children/teens/young adults) of developing cancer||
9299|034|W|(such as lymphoma, skin cancer) due to this medication or due to||
9299|035|W|your medical condition. Discuss the risks and benefits of||
9299|036|W|treatment with your doctor. Tell your doctor right away if you||
9299|037|W|develop symptoms such as a fever that doesn't go away, unusual||
9299|038|W|lumps/growths, swollen lymph nodes, unexplained weight loss, or||
9299|039|W|night sweats.||
9299|040|B|||
9299|041|U|USES:  Adalimumab is used to reduce pain and swelling due to||
9299|042|U|certain types of arthritis (such as rheumatoid, psoriatic,||
9299|043|U|juvenile idiopathic, ankylosing spondylitis). This medication is||
9299|044|U|also used to treat certain skin disorders (such as plaque-type||
9299|045|U|psoriasis, hidradenitis suppurativa). It works by blocking a||
9299|046|U|protein (tumor necrosis factor or TNF) found in the body's immune||
9299|047|U|system that causes joint swelling and damage in arthritis as well||
9299|048|U|as red scaly patches in psoriasis. Adalimumab belongs to a class||
9299|049|U|of drugs known as TNF blockers. By reducing joint swelling, this||
9299|050|U|medication helps to reduce further joint damage and preserve||
9299|051|U|joint function.||
9299|052|U|   Adalimumab is also used to treat certain bowel conditions||
9299|053|U|(Crohn's disease, ulcerative colitis) and a certain eye disease||
9299|054|U|(uveitis).||
9299|055|U|   This monograph is about the following adalimumab products:||
9299|056|U|adalimumab, adalimumab-aacf, adalimumab-aaty, adalimumab-adaz,||
9299|057|U|adalimumab-adbm, adalimumab-afzb, adalimumab-aqvh,||
9299|058|U|adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp, and||
9299|059|U|adalimumab-ryvk.||
9299|060|B|||
9299|061|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
9299|062|H|provided by your pharmacist before you start using adalimumab and||
9299|063|H|each time you get a refill. Ask your health care professional how||
9299|064|H|to prepare and use this medication. If you have any questions,||
9299|065|H|ask your doctor or pharmacist.||
9299|066|H|   Inject this medication under the skin as directed by your||
9299|067|H|doctor, usually every other week or once a week in some cases.||
9299|068|H|The injection is given in the thigh or abdomen. The dosage is||
9299|069|H|based on your medical condition and response to treatment.||
9299|070|H|Children's dosage is also based on weight. If you are using this||
9299|071|H|medication to treat psoriasis, hidradenitis suppurativa, Crohn's||
9299|072|H|disease, ulcerative colitis, or uveitis, your doctor may||
9299|073|H|prescribe a different schedule/higher dose at the start of your||
9299|074|H|treatment. Carefully follow your doctor's directions for using||
9299|075|H|this medication.||
9299|076|H|   Take the medication out of the refrigerator 15 to 30 minutes||
9299|077|H|before you inject it to allow it to reach room temperature. Do||
9299|078|H|not warm up this medication any other way (for example, do not||
9299|079|H|heat in the microwave or place it in hot water). Before using,||
9299|080|H|check this product for particles or discoloration. If either is||
9299|081|H|present, do not use the liquid. Before injecting each dose, clean||
9299|082|H|the skin you are going to inject into (the injection site) with||
9299|083|H|rubbing alcohol. Change the injection site each time to lessen||
9299|084|H|injury under the skin. New injections should be given at least 1||
9299|085|H|inch (2.5 centimeters) from an old site. Do not inject into skin||
9299|086|H|that is sore, bruised, red, or hard. To lessen bruising, do not||
9299|087|H|rub the injection site after a shot. Learn how to store and||
9299|088|H|discard medical supplies safely.||
9299|089|H|   Use this medication regularly to get the most benefit from it.||
9299|090|H|To help you remember, mark your calendar with a reminder. Do not||
9299|091|H|increase your dose or use this drug more often or for longer than||
9299|092|H|prescribed.||
9299|093|H|   Tell your doctor if your condition lasts or gets worse.||
9299|094|B|||
9299|095|S|SIDE EFFECTS:  See also Warning section.||
9299|096|S|   Redness, itching, pain, or swelling at the injection site may||
9299|097|S|occur. If any of these effects last or get worse, tell your||
9299|098|S|doctor or pharmacist promptly.||
9299|099|S|   Remember that this medication has been prescribed because your||
9299|100|S|doctor has judged that the benefit to you is greater than the||
9299|101|S|risk of side effects. Many people using this medication do not||
9299|102|S|have serious side effects.||
9299|103|S|   Tell your doctor right away if you develop signs of infection||
9299|104|S|while using this drug, such as: sore throat that doesn't go away,||
9299|105|S|cough, fever, chills, night sweats, trouble breathing,||
9299|106|S|painful/frequent urination, unusual vaginal discharge, white||
9299|107|S|patches in the mouth (oral thrush).||
9299|108|S|   Tell your doctor right away if you have any serious side||
9299|109|S|effects, including: fast/irregular/pounding heartbeat, new or||
9299|110|S|worsening symptoms of heart failure (such as shortness of breath,||
9299|111|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
9299|112|S|gain), blood in the stools, mental/mood changes, severe headache,||
9299|113|S|easy bruising/bleeding, leg pain/swelling, numbness or tingling||
9299|114|S|of the arms/hands/legs/feet, unsteadiness, unexplained muscle||
9299|115|S|weakness, difficulty with speaking/chewing/swallowing/facial||
9299|116|S|movements, vision changes, joint pain, butterfly-shaped rash on||
9299|117|S|the nose and cheeks.||
9299|118|S|   Adalimumab may rarely cause serious (possibly fatal) liver||
9299|119|S|disease in people exposed to hepatitis B virus. Your doctor may||
9299|120|S|order blood tests and watch for symptoms during treatment and for||
9299|121|S|several months after your last treatment. Get medical help right||
9299|122|S|away if you have any symptoms of liver damage, including:||
9299|123|S|nausea/vomiting that doesn't stop, loss of appetite,||
9299|124|S|stomach/abdominal pain, yellowing eyes/skin, dark urine.||
9299|125|S|   Get medical help right away if you have any very serious side||
9299|126|S|effects, including: seizures, chest pain.||
9299|127|S|   A very serious allergic reaction to this drug is rare.||
9299|128|S|However, get medical help right away if you notice any symptoms||
9299|129|S|of a serious allergic reaction, including: rash, itching/swelling||
9299|130|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9299|131|S|breathing.||
9299|132|S|   This is not a complete list of possible side effects. If you||
9299|133|S|notice other effects not listed above, contact your doctor or||
9299|134|S|pharmacist.||
9299|135|S|   In the US -||
9299|136|S|   Call your doctor for medical advice about side effects. You||
9299|137|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9299|138|S|www.fda.gov/medwatch.||
9299|139|S|   In Canada - Call your doctor for medical advice about side||
9299|140|S|effects. You may report side effects to Health Canada at||
9299|141|S|1-866-234-2345.||
9299|142|B|||
9299|143|P|PRECAUTIONS:  See also Warning section.||
9299|144|P|   Before using adalimumab, tell your doctor or pharmacist if you||
9299|145|P|are allergic to it; or to any adalimumab products; or if you have||
9299|146|P|any other allergies. This product may contain inactive||
9299|147|P|ingredients (such as natural rubber/latex), which can cause||
9299|148|P|allergic reactions or other problems. Talk to your pharmacist for||
9299|149|P|more details.||
9299|150|P|   Before using this medication, tell your doctor or pharmacist||
9299|151|P|your medical history, especially of: current/recent/repeated||
9299|152|P|infections (such as hepatitis B, TB infection, histoplasmosis),||
9299|153|P|blood/bone marrow problems (such as low red/white blood cells and||
9299|154|P|platelets), seizures, certain brain/nerve disorders (such as||
9299|155|P|multiple sclerosis, Guillain-Barre syndrome), cancer, heart||
9299|156|P|disease (especially heart failure), lupus.||
9299|157|P|   Adalimumab can make you more likely to get infections or may||
9299|158|P|make current infections worse. Stay away from anyone who has an||
9299|159|P|infection that may easily spread (such as chickenpox, COVID-19,||
9299|160|P|measles, flu). Talk to your doctor if you have been exposed to an||
9299|161|P|infection or for more details.||
9299|162|P|   Tell your health care professional that you are using||
9299|163|P|adalimumab before having any immunizations/vaccinations. Avoid||
9299|164|P|contact with people who have recently received live vaccines||
9299|165|P|(such as flu vaccine inhaled through the nose).||
9299|166|P|   To lower the chance of getting cut, bruised, or injured, use||
9299|167|P|caution with sharp objects like razors and nail cutters, and||
9299|168|P|avoid activities such as contact sports.||
9299|169|P|   Before having surgery, tell your doctor or dentist about all||
9299|170|P|the products you use (including prescription drugs,||
9299|171|P|nonprescription drugs, and herbal products).||
9299|172|P|   Older adults may be at greater risk for infections and cancer||
9299|173|P|while using this drug.||
9299|174|P|   During pregnancy, this medication should be used only when||
9299|175|P|clearly needed. Discuss the risks and benefits with your doctor.||
9299|176|P|Mothers who have used this medication during pregnancy should ask||
9299|177|P|a doctor about immunizations/vaccinations for their newborn||
9299|178|P|babies.||
9299|179|P|   This medication passes into breast milk. Consult your doctor||
9299|180|P|before breastfeeding.||
9299|181|B|||
9299|182|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9299|183|I|medications work or increase your risk for serious side effects.||
9299|184|I|This document does not contain all possible drug interactions.||
9299|185|I|Keep a list of all the products you use (including||
9299|186|I|prescription/nonprescription drugs and herbal products) and share||
9299|187|I|it with your doctor and pharmacist. Do not start, stop, or change||
9299|188|I|the dosage of any medicines without your doctor's approval.||
9299|189|I|   Some products that may interact with this drug include: other||
9299|190|I|TNF blockers (such as etanercept, infliximab), other drugs that||
9299|191|I|weaken the immune system (such as abatacept, anakinra).||
9299|192|B|||
9299|193|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9299|194|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9299|195|O|poison control center right away. US residents can call||
9299|196|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9299|197|B|||
9299|198|N|NOTES:  Do not share this medication with others.||
9299|199|N|   Lab and/or medical tests (such as complete blood count, liver||
9299|200|N|function) should be done while you are using this medication.||
9299|201|N|Keep all medical and lab appointments. Consult your doctor for||
9299|202|N|more details.||
9299|203|B|||
9299|204|D|MISSED DOSE:  If you miss a dose, ask your doctor or pharmacist||
9299|205|D|right away for a new dosing schedule. Do not double the dose to||
9299|206|D|catch up.||
9299|207|B|||
9299|208|R|STORAGE:  Store in the refrigerator. Do not freeze. Keep the||
9299|209|R|medication in the original container to protect from light. Some||
9299|210|R|brands of this medication may also be stored at room temperature||
9299|211|R|if needed. Ask your pharmacist or read the product package to see||
9299|212|R|if your medication can be stored at room temperature and for how||
9299|213|R|long. Discard any unused portion of the medication. Keep all||
9299|214|R|medications away from children and pets.||
9299|215|R|   Do not flush medications down the toilet or pour them into a||
9299|216|R|drain unless instructed to do so. Properly discard this product||
9299|217|R|when it is expired or no longer needed. Consult your pharmacist||
9299|218|R|or local waste disposal company.||
9299|219|B|||
9299|220|M|MEDICAL ALERT:  Your condition can cause complications in a||
9299|221|M|medical emergency. For information about enrolling in MedicAlert,||
9299|222|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9299|223|B|||
9299|224|A|Information last revised November 2025.||
9299|225|A|Copyright(c) 2025 First Databank, Inc.||
9299|226|B|||
9300|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9300|002|Z|does NOT have all possible information about this product. This||
9300|003|Z|information does not assure that this product is safe, effective,||
9300|004|Z|or appropriate for you. This information is not individual||
9300|005|Z|medical advice and does not substitute for the advice of your||
9300|006|Z|health care professional. Always ask your health care||
9300|007|Z|professional for complete information about this product and your||
9300|008|Z|specific health needs.||
9300|009|B|||
9300|010|T|ESTRADIOL RING - VAGINAL||
9300|011|F|(ES-tra-DYE-ol)||
9300|012|B|||
9300|013|C|COMMON BRAND NAME(S): Estring||
9300|014|B|||
9300|015|W|WARNING:  Estrogens, either used alone or with another hormone||
9300|016|W|(progestin), have rarely caused very serious side effects.||
9300|017|W|Discuss the risks and benefits of hormone treatment with your||
9300|018|W|doctor. Estrogens should not be used to prevent heart disease or||
9300|019|W|dementia.||
9300|020|W|   Estrogens can increase the risk of cancer of the uterus||
9300|021|W|(endometrial cancer). Taking a progestin as directed by your||
9300|022|W|doctor can help decrease this risk. Tell your doctor right away||
9300|023|W|if you have any unusual vaginal bleeding.||
9300|024|W|   In postmenopausal women, estrogens, taken with or without a||
9300|025|W|progestin, increase the risk of cancer of the breast/ovaries,||
9300|026|W|stroke, dementia, and serious blood clots. When used along with a||
9300|027|W|progestin, estrogens also increase the risk of heart disease||
9300|028|W|(such as heart attacks).||
9300|029|W|   The risk for serious side effects may depend on the dose of||
9300|030|W|estrogen and the length of time it is used. This medication||
9300|031|W|should be used at the lowest effective dose and for the shortest||
9300|032|W|amount of time. Discuss the use of this medication with your||
9300|033|W|doctor and check with him/her regularly (for example, every 3 to||
9300|034|W|6 months) to see if you still need to take this medication. If||
9300|035|W|you will be taking this medication long-term, you should have||
9300|036|W|regular complete physical exams (for example, once a year) as||
9300|037|W|directed by your doctor. See also Notes section.||
9300|038|B|||
9300|039|U|USES:  This medication is a hormone (estrogen). It is used by||
9300|040|U|women to help reduce vaginal and urinary symptoms of menopause||
9300|041|U|(such as vaginal dryness/burning/itching, painful urination,||
9300|042|U|frequent urges to urinate). These symptoms are caused by the body||
9300|043|U|making less estrogen. When treating only vaginal symptoms of||
9300|044|U|menopause, products applied directly inside the vagina (such as||
9300|045|U|this medication) should be used first. Estrogens that are taken||
9300|046|U|by mouth, absorbed through the skin, or injected may have greater||
9300|047|U|risks of side effects due to more estrogen being absorbed.||
9300|048|B|||
9300|049|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9300|050|H|from your pharmacist before you start using this medication and||
9300|051|H|each time you get a refill. Learn how to use this medication||
9300|052|H|properly. If you have any questions, ask your doctor or||
9300|053|H|pharmacist.||
9300|054|H|   Wash and dry your hands before handling the ring. Insert the||
9300|055|H|ring high into the vagina as directed. The ring is usually left||
9300|056|H|in place for 90 days and then removed and replaced with a new||
9300|057|H|ring if treatment is to be continued. Do not leave a ring in||
9300|058|H|place for longer than 90 days. Follow the dosing schedule||
9300|059|H|carefully.||
9300|060|H|   If the ring is put in properly, you should not be able to feel||
9300|061|H|it and it will not interfere with sexual intercourse. If you are||
9300|062|H|able to feel the ring or feel slight discomfort from the ring, it||
9300|063|H|may mean that the ring is not high enough. Gently push the ring||
9300|064|H|higher with your finger.||
9300|065|H|   If the ring falls out of the vagina, rinse the ring with||
9300|066|H|lukewarm water and put it back into the vagina. Contact your||
9300|067|H|doctor if the ring falls out often.||
9300|068|H|   The ring is removed by hooking your finger through the ring||
9300|069|H|and gently pulling it out. Contact your doctor if you have||
9300|070|H|trouble removing the ring. Discard the used ring in the trash. Do||
9300|071|H|not flush it down the toilet.||
9300|072|H|   It may take 2 to 3 weeks before you get the full benefit of||
9300|073|H|this medication. Tell your doctor if your condition does not get||
9300|074|H|better or if it gets worse.||
9300|075|B|||
9300|076|S|SIDE EFFECTS:  See also Warning section.||
9300|077|S|   Nausea/vomiting, bloating, increased vaginal discharge, breast||
9300|078|S|tenderness, headache, or weight changes may occur. If any of||
9300|079|S|these effects last or get worse, tell your doctor or pharmacist||
9300|080|S|promptly.||
9300|081|S|   Remember that this medication has been prescribed because your||
9300|082|S|doctor has judged that the benefit to you is greater than the||
9300|083|S|risk of side effects. Many people using this medication do not||
9300|084|S|have serious side effects.||
9300|085|S|   Tell your doctor right away if you have any serious side||
9300|086|S|effects, including: nausea/vomiting that doesn't stop,||
9300|087|S|mental/mood changes (such as depression, memory loss), breast||
9300|088|S|lumps, unusual vaginal bleeding (such as spotting, breakthrough||
9300|089|S|bleeding, prolonged/recurrent bleeding), unusual vaginal||
9300|090|S|irritation/itching/odor/discharge, severe stomach/abdominal pain,||
9300|091|S|yellowing eyes/skin, dark urine, swelling hands/ankles/feet,||
9300|092|S|increased thirst/urination.||
9300|093|S|   This medication may rarely cause serious (sometimes fatal)||
9300|094|S|problems from blood clots (such as heart attack, stroke, blood||
9300|095|S|clots in the lungs or legs). Get medical help right away if you||
9300|096|S|have: chest/jaw/left arm pain, unusual sweating, sudden/severe||
9300|097|S|headaches, weakness on one side of the body, confusion, trouble||
9300|098|S|speaking, sudden vision changes, pain/swelling/warmth in the||
9300|099|S|groin/calf, shortness of breath/rapid breathing, sudden||
9300|100|S|dizziness/fainting.||
9300|101|S|   Vaginal rings have rarely caused a very serious (possibly||
9300|102|S|fatal) bacterial infection (toxic shock syndrome-TSS). Remove||
9300|103|S|this product and get medical help right away if you have any||
9300|104|S|symptoms of toxic shock syndrome, including: high fever, sudden||
9300|105|S|dizziness/fainting, unusual muscle pain, sunburn-like rash,||
9300|106|S|diarrhea.||
9300|107|S|   A very serious allergic reaction to this product is rare.||
9300|108|S|However, get medical help right away if you notice any symptoms||
9300|109|S|of a serious allergic reaction, including: rash, itching/swelling||
9300|110|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9300|111|S|breathing.||
9300|112|S|   This is not a complete list of possible side effects. If you||
9300|113|S|notice other effects not listed above, contact your doctor or||
9300|114|S|pharmacist.||
9300|115|S|   In the US -||
9300|116|S|   Call your doctor for medical advice about side effects. You||
9300|117|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9300|118|S|www.fda.gov/medwatch.||
9300|119|S|   In Canada - Call your doctor for medical advice about side||
9300|120|S|effects. You may report side effects to Health Canada at||
9300|121|S|1-866-234-2345.||
9300|122|B|||
9300|123|P|PRECAUTIONS:  Before using estradiol, tell your doctor or||
9300|124|P|pharmacist if you are allergic to it; or if you have any other||
9300|125|P|allergies. This product may contain inactive ingredients, which||
9300|126|P|can cause allergic reactions or other problems. Talk to your||
9300|127|P|pharmacist for more details.||
9300|128|P|   Before using this medication, tell your doctor or pharmacist||
9300|129|P|your medical history, especially of: vaginal bleeding of unknown||
9300|130|P|cause, certain cancers (such as breast cancer, cancer of the||
9300|131|P|uterus/ovaries), blood clots, stroke, heart disease (such as||
9300|132|P|heart attack), liver disease, kidney disease, family medical||
9300|133|P|history (especially breast lumps, cancer, blood clots), family or||
9300|134|P|personal history of a certain swelling disorder (angioedema),||
9300|135|P|blood clotting disorders (such as protein C or protein S||
9300|136|P|deficiency), high blood pressure, diabetes, high||
9300|137|P|cholesterol/triglyceride levels, obesity, lupus, underactive||
9300|138|P|thyroid (hypothyroidism), mineral imbalance (low or high level of||
9300|139|P|calcium in the blood), a certain hormone problem||
9300|140|P|(hypoparathyroidism), uterus problems (such as fibroids,||
9300|141|P|endometriosis), gallbladder disease, asthma, seizures, migraine||
9300|142|P|headaches, mental/mood disorders (such as dementia, depression),||
9300|143|P|a certain blood disorder (porphyria), frequent vaginal||
9300|144|P|infections.||
9300|145|P|   Do not smoke or use tobacco. Estrogens combined with smoking||
9300|146|P|further increases your risk of stroke, blood clots, high blood||
9300|147|P|pressure, and heart attack, especially in women older than 35.||
9300|148|P|   Tell your doctor if you just had or will be having surgery, or||
9300|149|P|if you will be confined to a chair or bed for a long time (such||
9300|150|P|as a long plane flight). These conditions increase your risk of||
9300|151|P|getting blood clots, especially if you are using an estrogen||
9300|152|P|product. You may need to stop this medication for a time or take||
9300|153|P|special precautions.||
9300|154|P|   This medication may cause blotchy, dark areas on your face and||
9300|155|P|skin (melasma). Sunlight may worsen this effect. Limit your time||
9300|156|P|in the sun. Avoid tanning booths and sunlamps. Use sunscreen and||
9300|157|P|wear protective clothing when outdoors.||
9300|158|P|   If you are nearsighted or wear contact lenses, you may develop||
9300|159|P|vision problems or trouble wearing your contact lenses. Contact||
9300|160|P|your eye doctor if these problems occur.||
9300|161|P|   If you get a vaginal infection while using this ring, it is||
9300|162|P|recommended that you remove the ring and resume treatment only||
9300|163|P|after the infection has been treated. Consult your doctor or||
9300|164|P|pharmacist for more information.||
9300|165|P|   This medication should not be used during pregnancy. If you||
9300|166|P|become pregnant or think you may be pregnant, tell your doctor||
9300|167|P|right away.||
9300|168|P|   This medication passes into breast milk. Consult your doctor||
9300|169|P|before breastfeeding.||
9300|170|B|||
9300|171|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9300|172|I|medications work or increase your risk for serious side effects.||
9300|173|I|This document does not contain all possible drug interactions.||
9300|174|I|Keep a list of all the products you use (including||
9300|175|I|prescription/nonprescription drugs and herbal products) and share||
9300|176|I|it with your doctor and pharmacist. Do not start, stop, or change||
9300|177|I|the dosage of any medicines without your doctor's approval.||
9300|178|I|   Some products that may interact with this drug include:||
9300|179|I|aromatase inhibitors (such as anastrozole, exemestane,||
9300|180|I|letrozole), fezolinetant, fulvestrant, ospemifene, raloxifene,||
9300|181|I|tamoxifen, toremifene, tranexamic acid.||
9300|182|I|   This medication may interfere with certain lab tests, possibly||
9300|183|I|causing false test results. Make sure lab personnel and all your||
9300|184|I|doctors know you use this drug.||
9300|185|B|||
9300|186|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9300|187|O|has overdosed and has serious symptoms such as passing out or||
9300|188|O|trouble breathing, call 911. Otherwise, call a poison control||
9300|189|O|center right away. US residents can call 1-800-222-1222. Canada||
9300|190|O|residents can call 1-844-764-7669. Symptoms of overdose may||
9300|191|O|include: severe nausea/vomiting, unusual vaginal bleeding.||
9300|192|B|||
9300|193|N|NOTES:  Do not share this medication with others.||
9300|194|N|   Regular complete physical exams which include lab and/or||
9300|195|N|medical tests (such as blood pressure, breast exam/mammogram,||
9300|196|N|pelvic exam, Pap smear) should be done while you are using this||
9300|197|N|medication. Follow your doctor's instructions for examining your||
9300|198|N|breasts, and report any lumps right away. Keep all medical and||
9300|199|N|lab appointments. Consult your doctor for more details.||
9300|200|N|   Preventing or controlling high blood pressure, high||
9300|201|N|cholesterol, and diabetes can help to reduce your chances of||
9300|202|N|heart disease and stroke. Lifestyle changes that can help to||
9300|203|N|control or prevent these diseases include reducing stress, eating||
9300|204|N|a low fat/salt diet, losing weight if overweight, exercising||
9300|205|N|regularly, and stopping smoking. Keep your mind active with||
9300|206|N|mental exercises (such as reading, solving crossword puzzles) to||
9300|207|N|help prevent dementia. Talk to your doctor about lifestyle||
9300|208|N|changes that might benefit you.||
9300|209|B|||
9300|210|D|MISSED DOSE:  Not applicable. However, if you have not inserted a||
9300|211|D|new ring after 90 days, ask your doctor or pharmacist right away||
9300|212|D|for a new dosing schedule.||
9300|213|B|||
9300|214|R|STORAGE:  Store at room temperature. Do not remove the ring from||
9300|215|R|the pouch until ready for use. Keep all medications away from||
9300|216|R|children and pets.||
9300|217|R|   Do not flush medications down the toilet or pour them into a||
9300|218|R|drain unless instructed to do so. Properly discard this product||
9300|219|R|when it is expired or no longer needed. Consult your pharmacist||
9300|220|R|or local waste disposal company.||
9300|221|B|||
9300|222|A|Information last revised November 2024.||
9300|223|A|Copyright(c) 2025 First Databank, Inc.||
9300|224|B|||
9301|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9301|002|Z|does NOT have all possible information about this product. This||
9301|003|Z|information does not assure that this product is safe, effective,||
9301|004|Z|or appropriate for you. This information is not individual||
9301|005|Z|medical advice and does not substitute for the advice of your||
9301|006|Z|health care professional. Always ask your health care||
9301|007|Z|professional for complete information about this product and your||
9301|008|Z|specific health needs.||
9301|009|B|||
9301|010|T|SIROLIMUS SOLUTION - ORAL||
9301|011|F|(sir-OH-li-mus)||
9301|012|B|||
9301|013|C|COMMON BRAND NAME(S): Rapamune||
9301|014|B|||
9301|015|W|WARNING:  Sirolimus lowers the body's ability to fight an||
9301|016|W|infection/disease (immunosuppression). This may increase your||
9301|017|W|risk of developing an infection or certain types of cancer (such||
9301|018|W|as skin cancer, lymphoma). To reduce the risk of these serious||
9301|019|W|side effects, take this medication at the lowest effective dose||
9301|020|W|as directed by your doctor. Keep all medical and lab||
9301|021|W|appointments.||
9301|022|W|   Tell your doctor right away if you develop any of the||
9301|023|W|following: unusual skin changes, change in the appearance/size of||
9301|024|W|moles, unusual growths/lumps, swollen lymph nodes, night sweats,||
9301|025|W|unexplained weight loss, signs of infection (such as sore throat||
9301|026|W|that doesn't go away, fever, chills).||
9301|027|W|   Sirolimus is not recommended for the prevention of rejection||
9301|028|W|of liver or lung transplants because it has rarely caused very||
9301|029|W|serious (possibly fatal) liver/lung problems in those cases.||
9301|030|B|||
9301|031|U|USES:  Sirolimus is used with other medications to prevent||
9301|032|U|rejection of a kidney transplant. This medication belongs to a||
9301|033|U|class of drugs known as immunosuppressants. It works by weakening||
9301|034|U|your body's defense system (immune system) to help your body||
9301|035|U|accept the new organ as if it were your own.||
9301|036|U|   Sirolimus may also be used to treat a certain lung disease||
9301|037|U|(lymphangioleiomyomatosis-LAM).||
9301|038|B|||
9301|039|V|OTHER USES:  This section contains uses of this drug that are not||
9301|040|V|listed in the approved professional labeling for the drug but||
9301|041|V|that may be prescribed by your health care professional. Use this||
9301|042|V|drug for a condition that is listed in this section only if it||
9301|043|V|has been so prescribed by your health care professional.||
9301|044|V|   This drug may also be used to reduce the risk of rejection of||
9301|045|V|a heart transplant.||
9301|046|B|||
9301|047|H|HOW TO USE:  Read the Medication Guide and Instructions for Use||
9301|048|H|provided by your pharmacist before you start taking sirolimus and||
9301|049|H|each time you get a refill. If you have any questions, ask your||
9301|050|H|doctor or pharmacist.||
9301|051|H|   Take this medication by mouth as directed by your doctor,||
9301|052|H|usually once daily. If you have nausea or an upset stomach, you||
9301|053|H|may take this medication with food. However, it is important to||
9301|054|H|choose one way (with food or without food) and take this||
9301|055|H|medication the same way with every dose.||
9301|056|H|   Carefully measure the dose using the amber oral dose syringe||
9301|057|H|provided. Do not use a household spoon because you may not get||
9301|058|H|the correct dose. Mix the measured dose with at least 2 ounces||
9301|059|H|(one-fourth cup/60 milliliters) of water or orange juice in a||
9301|060|H|plastic or glass container. Do not mix with any other liquids.||
9301|061|H|Stir well and drink all of the mixture right away. Refill the||
9301|062|H|container with at least 4 more ounces (one-half cup/120||
9301|063|H|milliliters) of water or orange juice, stir well, and drink it||
9301|064|H|right away. Do not prepare a supply in advance.||
9301|065|H|   The oral dose syringe should only be used once and thrown||
9301|066|H|away. Use a new syringe for each dose.||
9301|067|H|   The dosage is based on your weight, medical condition, lab||
9301|068|H|tests, and response to treatment.||
9301|069|H|   Take this medication regularly to get the most benefit from||
9301|070|H|it. To help you remember, take it at the same time each day.||
9301|071|H|   Do not increase your dose or take this medication more often||
9301|072|H|than prescribed. Your condition will not improve any faster, and||
9301|073|H|your risk of side effects will increase. Also, do not stop taking||
9301|074|H|this medication without consulting your doctor.||
9301|075|H|   If you are also taking cyclosporine, take sirolimus 4 hours||
9301|076|H|after your cyclosporine dose. Consult your pharmacist for more||
9301|077|H|information.||
9301|078|H|   Avoid eating grapefruit or drinking grapefruit juice while||
9301|079|H|using this medication unless your doctor or pharmacist says you||
9301|080|H|may do so safely. Grapefruit can increase the chance of side||
9301|081|H|effects with this medicine. Ask your doctor or pharmacist for||
9301|082|H|more details.||
9301|083|H|   If you are taking this medication to treat LAM, tell your||
9301|084|H|doctor if your condition gets worse.||
9301|085|B|||
9301|086|S|SIDE EFFECTS:  See also Warning section.||
9301|087|S|   Diarrhea, joint pain, shaking, acne, or trouble sleeping may||
9301|088|S|occur. If any of these effects last or get worse, tell your||
9301|089|S|doctor or pharmacist promptly.||
9301|090|S|   Remember that this medication has been prescribed because your||
9301|091|S|doctor has judged that the benefit to you is greater than the||
9301|092|S|risk of side effects. Many people using this medication do not||
9301|093|S|have serious side effects.||
9301|094|S|   Tell your doctor right away if you have any serious side||
9301|095|S|effects, including: nausea/vomiting that doesn't stop, yellowing||
9301|096|S|eyes/skin, dark urine, muscle pain/cramps, bone pain, increased||
9301|097|S|thirst/hunger, frequent urination, hearing problems (such as||
9301|098|S|hearing loss, ringing in the ears), unusual tiredness,||
9301|099|S|fast/slow/irregular heartbeat, easy bruising/bleeding,||
9301|100|S|mental/mood changes, swelling ankles/feet, severe headache,||
9301|101|S|dizziness, stomach/abdominal pain, missed/heavy/painful periods,||
9301|102|S|signs of kidney problems (such as change in the amount of urine,||
9301|103|S|frothy urine), pain/redness/swelling of arms or legs, swelling||
9301|104|S|abdomen.||
9301|105|S|   Get medical help right away if you have any very serious side||
9301|106|S|effects, including: chest pain, shortness of breath.||
9301|107|S|   This medication may increase your risk of getting a rare but||
9301|108|S|very serious (possibly fatal) brain infection (progressive||
9301|109|S|multifocal leukoencephalopathy-PML). Get medical help right away||
9301|110|S|if you have any of these side effects: clumsiness, loss of||
9301|111|S|coordination/balance, weakness, sudden change in your thinking||
9301|112|S|(such as confusion, difficulty concentrating, memory loss),||
9301|113|S|difficulty talking/walking, seizure, vision changes.||
9301|114|S|   Sirolimus may slow wound healing after surgery. Tell your||
9301|115|S|doctor right away if you have signs that your surgery wound is||
9301|116|S|not healing well (such as redness, swelling, pain). The risk of||
9301|117|S|poor wound healing is higher if you are obese.||
9301|118|S|   Sirolimus may cause your cholesterol/triglycerides to||
9301|119|S|increase. You may be required to have your||
9301|120|S|cholesterol/triglycerides checked periodically and/or take||
9301|121|S|another medication to control your cholesterol/triglycerides.||
9301|122|S|   Sirolimus can commonly cause a rash that is usually not||
9301|123|S|serious. However, you may not be able to tell it apart from a||
9301|124|S|rare rash that could be a sign of a severe reaction. Get medical||
9301|125|S|help right away if you develop any rash.||
9301|126|S|   A very serious allergic reaction to this drug is rare.||
9301|127|S|However, get medical help right away if you notice any symptoms||
9301|128|S|of a serious allergic reaction, including: rash, itching/swelling||
9301|129|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9301|130|S|breathing.||
9301|131|S|   This is not a complete list of possible side effects. If you||
9301|132|S|notice other effects not listed above, contact your doctor or||
9301|133|S|pharmacist.||
9301|134|S|   In the US -||
9301|135|S|   Call your doctor for medical advice about side effects. You||
9301|136|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9301|137|S|www.fda.gov/medwatch.||
9301|138|S|   In Canada - Call your doctor for medical advice about side||
9301|139|S|effects. You may report side effects to Health Canada at||
9301|140|S|1-866-234-2345.||
9301|141|B|||
9301|142|P|PRECAUTIONS:  Before taking sirolimus, tell your doctor or||
9301|143|P|pharmacist if you are allergic to it; or to temsirolimus; or if||
9301|144|P|you have any other allergies. This product may contain inactive||
9301|145|P|ingredients, which can cause allergic reactions or other||
9301|146|P|problems. Talk to your pharmacist for more details.||
9301|147|P|   Before using this medication, tell your doctor or pharmacist||
9301|148|P|your medical history, especially of: liver disease, high||
9301|149|P|cholesterol/triglyceride levels, cancer, any recent/current||
9301|150|P|infections.||
9301|151|P|   Sirolimus can make you more likely to get infections or may||
9301|152|P|make current infections worse. Stay away from anyone who has an||
9301|153|P|infection that may easily spread (such as chickenpox, COVID-19,||
9301|154|P|measles, flu). Talk to your doctor if you have been exposed to an||
9301|155|P|infection or for more details.||
9301|156|P|   Tell your health care professional that you are using||
9301|157|P|sirolimus before having any immunizations/vaccinations. Avoid||
9301|158|P|contact with people who have recently received live vaccines||
9301|159|P|(such as flu vaccine inhaled through the nose).||
9301|160|P|   This medication may increase your risk of developing skin||
9301|161|P|cancer. Limit your time in the sun. Avoid tanning booths and||
9301|162|P|sunlamps. Use sunscreen and wear protective clothing when||
9301|163|P|outdoors.||
9301|164|P|   Before having surgery, tell your doctor or dentist about all||
9301|165|P|the products you use (including prescription drugs,||
9301|166|P|nonprescription drugs, and herbal products).||
9301|167|P|   This medication can affect fertility in males. Ask your doctor||
9301|168|P|for more details.||
9301|169|P|   Tell your doctor if you are pregnant or plan to become||
9301|170|P|pregnant. You should not become pregnant while using sirolimus.||
9301|171|P|Sirolimus may harm an unborn baby. Ask about reliable forms of||
9301|172|P|birth control while using this medication and for 12 weeks after||
9301|173|P|the last dose. If you become pregnant, talk to your doctor right||
9301|174|P|away about the risks and benefits of this medication.||
9301|175|P|   This medication may pass into breast milk and may have||
9301|176|P|undesirable effects on a nursing infant. Breastfeeding is not||
9301|177|P|recommended while using this medication. Consult your doctor||
9301|178|P|before breastfeeding.||
9301|179|B|||
9301|180|I|DRUG INTERACTIONS:  See also How to Use section.||
9301|181|I|   Drug interactions may change how your medications work or||
9301|182|I|increase your risk for serious side effects. This document does||
9301|183|I|not contain all possible drug interactions. Keep a list of all||
9301|184|I|the products you use (including prescription/nonprescription||
9301|185|I|drugs and herbal products) and share it with your doctor and||
9301|186|I|pharmacist. Do not start, stop, or change the dosage of any||
9301|187|I|medicines without your doctor's approval.||
9301|188|I|   Some products that may interact with this drug include: ACE||
9301|189|I|inhibitors (such as benazepril, lisinopril), other drugs that||
9301|190|I|weaken the immune system/increase the risk of infection (such as||
9301|191|I|natalizumab, rituximab, tacrolimus).||
9301|192|I|   Other medications can affect the removal of sirolimus from||
9301|193|I|your body, which may affect how sirolimus works. Examples include||
9301|194|I|azole antifungals (such as itraconazole, ketoconazole,||
9301|195|I|voriconazole), enzalutamide, macrolide antibiotics (such as||
9301|196|I|clarithromycin, erythromycin), mifepristone, rifamycins (such as||
9301|197|I|rifampin, rifabutin), ritonavir, St. John's wort, among others.||
9301|198|I|   Sirolimus is very similar to temsirolimus. Do not use||
9301|199|I|medications containing temsirolimus while using sirolimus.||
9301|200|B|||
9301|201|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9301|202|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9301|203|O|poison control center right away. US residents can call||
9301|204|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9301|205|B|||
9301|206|N|NOTES:  Lab and/or medical tests (such as kidney/liver function,||
9301|207|N|cholesterol/triglyceride levels, urine tests for protein,||
9301|208|N|sirolimus trough level) will be done while you are taking this||
9301|209|N|medication. Keep all medical and lab appointments. Consult your||
9301|210|N|doctor for more details.||
9301|211|N|   If you had an organ transplant, attend a transplant education||
9301|212|N|class or support group to learn more about the signs of organ||
9301|213|N|rejection such as a feeling of being ill, fever, or||
9301|214|N|tenderness/pain around the transplanted organ. Tell your doctor||
9301|215|N|right away if you notice any of these signs.||
9301|216|B|||
9301|217|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9301|218|D|remember. If it is near the time of the next dose, skip the||
9301|219|D|missed dose. Take your next dose at the regular time. Do not||
9301|220|D|double the dose to catch up.||
9301|221|B|||
9301|222|R|STORAGE:  Store upright in the refrigerator away from light. Do||
9301|223|R|not freeze. This medication may also be stored at room||
9301|224|R|temperature if needed. Check the product package for how long||
9301|225|R|your brand can be stored at room temperature or ask your||
9301|226|R|pharmacist. Once the bottle is opened, this medication expires||
9301|227|R|after 30 days. If the medication is stored in the oral syringe||
9301|228|R|with the cap on, then the medication should be used within 24||
9301|229|R|hours. Keep all medications away from children and pets.||
9301|230|R|   When refrigerated, the medication in the bottle may develop a||
9301|231|R|slight haze. If this haze occurs, allow the medication to stand||
9301|232|R|at room temperature and shake gently until the haze disappears.||
9301|233|R|The haze does not affect the quality of the drug.||
9301|234|R|   Do not flush medications down the toilet or pour them into a||
9301|235|R|drain unless instructed to do so. Properly discard this product||
9301|236|R|when it is expired or no longer needed. Consult your pharmacist||
9301|237|R|or local waste disposal company.||
9301|238|B|||
9301|239|M|MEDICAL ALERT:  Your condition can cause complications in a||
9301|240|M|medical emergency. For information about enrolling in MedicAlert,||
9301|241|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9301|242|B|||
9301|243|A|Information last revised May 2025.||
9301|244|A|Copyright(c) 2025 First Databank, Inc.||
9301|245|B|||
9302|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9302|002|Z|does NOT have all possible information about this product. This||
9302|003|Z|information does not assure that this product is safe, effective,||
9302|004|Z|or appropriate for you. This information is not individual||
9302|005|Z|medical advice and does not substitute for the advice of your||
9302|006|Z|health care professional. Always ask your health care||
9302|007|Z|professional for complete information about this product and your||
9302|008|Z|specific health needs.||
9302|009|B|||
9302|010|T|SEVELAMER - ORAL||
9302|011|F|(seh-VELL-uh-mer)||
9302|012|B|||
9302|013|C|COMMON BRAND NAME(S): Renagel, Renvela||
9302|014|B|||
9302|015|U|USES:  Sevelamer is used to lower high blood phosphorus||
9302|016|U|(phosphate) levels in patients who are on dialysis due to severe||
9302|017|U|kidney disease. Dialysis removes some phosphate from your blood,||
9302|018|U|but it is difficult to remove enough to keep your phosphate||
9302|019|U|levels balanced. Decreasing blood phosphate levels can help keep||
9302|020|U|your bones strong, prevent unsafe buildup of minerals in your||
9302|021|U|body, and possibly decrease the risk of heart disease and strokes||
9302|022|U|that can result from high phosphate levels. Sevelamer works by||
9302|023|U|holding onto phosphate from the diet so that it can pass out of||
9302|024|U|your body.||
9302|025|B|||
9302|026|H|HOW TO USE:  Take this medication by mouth as directed by your||
9302|027|H|doctor, usually 3 times daily with meals. Swallow the tablet||
9302|028|H|whole. Do not crush, chew, or split the tablet. The dosage is||
9302|029|H|based on your medical condition, any other medications you take||
9302|030|H|to lower your phosphate levels, and your response to treatment.||
9302|031|H|Children's dosage is also based on body size.||
9302|032|H|   If you are taking the powder form of this medication, check||
9302|033|H|the manufacturer package directions for mixing with water,||
9302|034|H|beverage, or food and taking it within 30 minutes. Follow the||
9302|035|H|directions for the proper amount of water to use for your dose.||
9302|036|H|Stir the mixture well and drink all of it. If the powder settles||
9302|037|H|to the bottom of the cup, stir again right before drinking. You||
9302|038|H|may also mix the powder with a small amount of food or beverage||
9302|039|H|to take as part of a meal. If mixing with food or beverage, do||
9302|040|H|not heat the powder or add to heated foods or liquids.||
9302|041|H|   Take this medication regularly in order to get the most||
9302|042|H|benefit from it. Remember to take it 3 times a day with meals, or||
9302|043|H|on the schedule given to you by your doctor.||
9302|044|B|||
9302|045|S|SIDE EFFECTS:  Headache, diarrhea, stomach upset, nausea,||
9302|046|S|vomiting, cough, gas, or constipation may occur. If any of these||
9302|047|S|effects last or get worse, tell your doctor or pharmacist||
9302|048|S|promptly.||
9302|049|S|   Remember that this medication has been prescribed because your||
9302|050|S|doctor has judged that the benefit to you is greater than the||
9302|051|S|risk of side effects. Many people using this medication do not||
9302|052|S|have serious side effects.||
9302|053|S|   Tell your doctor right away if you have any serious side||
9302|054|S|effects, including: problems with your dialysis access site,||
9302|055|S|severe constipation/inability to have a bowel movement, signs of||
9302|056|S|stomach/intestinal bleeding or ulcers (such as black/bloody||
9302|057|S|stools, vomit that looks like coffee grounds, stomach/abdominal||
9302|058|S|pain, dizziness).||
9302|059|S|   Get medical help right away if you have any very serious side||
9302|060|S|effects, including: trouble breathing, chest pain,||
9302|061|S|pain/redness/swelling in the lower legs.||
9302|062|S|   A very serious allergic reaction to this drug is rare.||
9302|063|S|However, get medical help right away if you notice any symptoms||
9302|064|S|of a serious allergic reaction, including: rash, itching/swelling||
9302|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9302|066|S|breathing.||
9302|067|S|   This is not a complete list of possible side effects. If you||
9302|068|S|notice other effects not listed above, contact your doctor or||
9302|069|S|pharmacist.||
9302|070|S|   In the US -||
9302|071|S|   Call your doctor for medical advice about side effects. You||
9302|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9302|073|S|www.fda.gov/medwatch.||
9302|074|S|   In Canada - Call your doctor for medical advice about side||
9302|075|S|effects. You may report side effects to Health Canada at||
9302|076|S|1-866-234-2345.||
9302|077|B|||
9302|078|P|PRECAUTIONS:  Before taking sevelamer, tell your doctor or||
9302|079|P|pharmacist if you are allergic to it; or if you have any other||
9302|080|P|allergies. This product may contain inactive ingredients, which||
9302|081|P|can cause allergic reactions or other problems. Talk to your||
9302|082|P|pharmacist for more details.||
9302|083|P|   Before using this medication, tell your doctor or pharmacist||
9302|084|P|your medical history, especially of: low blood phosphorus levels,||
9302|085|P|stomach/intestinal problems (such as blockage, colitis,||
9302|086|P|constipation, ulcers), stomach/intestinal surgeries, swallowing||
9302|087|P|problems (dysphagia).||
9302|088|P|   Before having surgery, tell your doctor or dentist about all||
9302|089|P|the products you use (including prescription drugs,||
9302|090|P|nonprescription drugs, and herbal products).||
9302|091|P|   During pregnancy, this medication should be used only when||
9302|092|P|clearly needed. Discuss the risks and benefits with your doctor.||
9302|093|P|   It is unknown if this medication passes into breast milk.||
9302|094|P|Consult your doctor before breastfeeding.||
9302|095|B|||
9302|096|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9302|097|I|medications work or increase your risk for serious side effects.||
9302|098|I|This document does not contain all possible drug interactions.||
9302|099|I|Keep a list of all the products you use (including||
9302|100|I|prescription/nonprescription drugs and herbal products) and share||
9302|101|I|it with your doctor and pharmacist. Do not start, stop, or change||
9302|102|I|the dosage of any medicines without your doctor's approval.||
9302|103|I|   Sevelamer may interfere with the effectiveness of some drugs||
9302|104|I|(including ciprofloxacin, mycophenolate, thyroid medications such||
9302|105|I|as levothyroxine, among others) by making it more difficult for||
9302|106|I|them to be absorbed by the stomach. Ask your pharmacist about the||
9302|107|I|best times to take your other medications.||
9302|108|B|||
9302|109|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9302|110|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9302|111|O|poison control center right away. US residents can call||
9302|112|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9302|113|B|||
9302|114|N|NOTES:  Your doctor may direct you to follow a special diet to||
9302|115|N|help lower your blood phosphate levels. Follow the diet closely.||
9302|116|N|   Do not share this medication with others.||
9302|117|N|   Lab and/or medical tests (such as blood phosphate, calcium,||
9302|118|N|bicarbonate and chloride levels) should be done while you are||
9302|119|N|taking this medication. Keep all medical and lab appointments.||
9302|120|N|Consult your doctor for more details.||
9302|121|B|||
9302|122|D|MISSED DOSE:  If you miss a dose, skip the missed dose unless you||
9302|123|D|have just eaten. If it is near the time of the next dose, skip||
9302|124|D|the missed dose. Take your next dose at the regular time. Do not||
9302|125|D|double the dose to catch up.||
9302|126|B|||
9302|127|R|STORAGE:  Store at room temperature away from light and moisture.||
9302|128|R|Do not store in the bathroom. Keep all medications away from||
9302|129|R|children and pets.||
9302|130|R|   Do not flush medications down the toilet or pour them into a||
9302|131|R|drain unless instructed to do so. Properly discard this product||
9302|132|R|when it is expired or no longer needed. Consult your pharmacist||
9302|133|R|or local waste disposal company.||
9302|134|B|||
9302|135|A|Information last revised August 2024.||
9302|136|A|Copyright(c) 2025 First Databank, Inc.||
9302|137|B|||
9306|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9306|002|Z|does NOT have all possible information about this product. This||
9306|003|Z|information does not assure that this product is safe, effective,||
9306|004|Z|or appropriate for you. This information is not individual||
9306|005|Z|medical advice and does not substitute for the advice of your||
9306|006|Z|health care professional. Always ask your health care||
9306|007|Z|professional for complete information about this product and your||
9306|008|Z|specific health needs.||
9306|009|B|||
9306|010|T|HYOSCYAMINE DISINTEGRATING TABLET - ORAL||
9306|011|F|(hi-oh-SYE-uh-meen)||
9306|012|B|||
9306|013|C|COMMON BRAND NAME(S): Nulev||
9306|014|B|||
9306|015|U|USES:  Hyoscyamine is used to treat a variety of||
9306|016|U|stomach/intestinal problems such as cramps and irritable bowel||
9306|017|U|syndrome. It is also used to treat other conditions such as||
9306|018|U|bladder and bowel control problems, cramping pain caused by||
9306|019|U|kidney stones and gallstones, and Parkinson's disease. In||
9306|020|U|addition, it is used to decrease side effects of certain||
9306|021|U|medications (drugs used to treat myasthenia gravis) and||
9306|022|U|insecticides.||
9306|023|U|   This medication works by decreasing acid production in the||
9306|024|U|stomach, slowing down the natural movements of the gut, and||
9306|025|U|relaxing muscles in many organs (such as the stomach, intestines,||
9306|026|U|bladder, kidney, gallbladder). Hyoscyamine also lessens the||
9306|027|U|amount of certain body fluids (such as saliva, sweat). This||
9306|028|U|medication belongs to a class of drugs known as||
9306|029|U|anticholinergics/antispasmodics.||
9306|030|B|||
9306|031|H|HOW TO USE:  Place this medication on your tongue. Let it quickly||
9306|032|H|dissolve and then swallow. You may take this medication with or||
9306|033|H|without water.||
9306|034|H|   The dosage is based on your medical condition and response to||
9306|035|H|treatment. Do not increase your dose or take it more often than||
9306|036|H|prescribed without consulting your doctor. Adults and children 12||
9306|037|H|years and older should not take more than 1.5 milligrams in 24||
9306|038|H|hours. Children aged 2 to 12 years should not take more than 0.75||
9306|039|H|milligrams in 24 hours. Ask your doctor or pharmacist for more||
9306|040|H|information.||
9306|041|H|   Antacids lower the absorption of hyoscyamine. If you use||
9306|042|H|antacids, take them after meals and take hyoscyamine before||
9306|043|H|meals; or take antacids at least 1 hour after taking hyoscyamine.||
9306|044|H|   Drink plenty of fluids while taking this medication unless||
9306|045|H|your doctor directs you otherwise.||
9306|046|H|   Tell your doctor if your condition lasts or gets worse.||
9306|047|B|||
9306|048|S|SIDE EFFECTS:  Dizziness, drowsiness, blurred vision, dry mouth,||
9306|049|S|headache, trouble sleeping, constipation, flushing, dry skin, and||
9306|050|S|decreased sweating may occur. If any of these effects last or get||
9306|051|S|worse, tell your doctor or pharmacist promptly.||
9306|052|S|   To relieve dry mouth, suck on (sugarless) hard candy or ice||
9306|053|S|chips, chew (sugarless) gum, drink water or use a saliva||
9306|054|S|substitute.||
9306|055|S|   Remember that this medication has been prescribed because your||
9306|056|S|doctor has judged that the benefit to you is greater than the||
9306|057|S|risk of side effects. Many people using this medication do not||
9306|058|S|have serious side effects.||
9306|059|S|   Tell your doctor right away if you have any serious side||
9306|060|S|effects, including: mental/mood changes (such as confusion,||
9306|061|S|unusual excitement), fast/irregular heartbeat, difficulty||
9306|062|S|urinating, decreased sexual ability, loss of coordination,||
9306|063|S|trouble speaking, vomiting.||
9306|064|S|   Get medical help right away if you have any very serious side||
9306|065|S|effects, including: eye pain/swelling/redness, vision changes||
9306|066|S|(such as seeing rainbows around lights at night).||
9306|067|S|   A very serious allergic reaction to this drug is rare.||
9306|068|S|However, get medical help right away if you notice any symptoms||
9306|069|S|of a serious allergic reaction, including: rash, itching/swelling||
9306|070|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9306|071|S|breathing.||
9306|072|S|   This is not a complete list of possible side effects. If you||
9306|073|S|notice other effects not listed above, contact your doctor or||
9306|074|S|pharmacist.||
9306|075|S|   In the US -||
9306|076|S|   Call your doctor for medical advice about side effects. You||
9306|077|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9306|078|S|www.fda.gov/medwatch.||
9306|079|S|   In Canada - Call your doctor for medical advice about side||
9306|080|S|effects. You may report side effects to Health Canada at||
9306|081|S|1-866-234-2345.||
9306|082|B|||
9306|083|P|PRECAUTIONS:  Before taking hyoscyamine, tell your doctor or||
9306|084|P|pharmacist if you are allergic to it; or to atropine; or if you||
9306|085|P|have any other allergies. This product may contain inactive||
9306|086|P|ingredients, which can cause allergic reactions or other||
9306|087|P|problems. Talk to your pharmacist for more details.||
9306|088|P|   Before using this medication, tell your doctor or pharmacist||
9306|089|P|your medical history, especially of: enlarged prostate, urinary||
9306|090|P|blockage problems, certain stomach/intestinal problems (such as||
9306|091|P|slow gut, blockage, severe ulcerative colitis, infection),||
9306|092|P|personal or family history of glaucoma (angle-closure type),||
9306|093|P|overactive thyroid, heart problems (such as coronary heart||
9306|094|P|disease, heart failure, fast heartbeat, arrhythmias), high blood||
9306|095|P|pressure, kidney disease, heartburn problems (acid reflux, hiatal||
9306|096|P|hernia), certain nervous system problem (autonomic neuropathy),||
9306|097|P|myasthenia gravis.||
9306|098|P|   Contact lens wearers may need to use wetting eye drops since||
9306|099|P|this medication can cause dry eyes.||
9306|100|P|   This medicine may contain aspartame. If you have||
9306|101|P|phenylketonuria (PKU) or any other condition where you must||
9306|102|P|restrict your intake of aspartame (or phenylalanine), consult||
9306|103|P|your doctor or pharmacist regarding the safe use of this||
9306|104|P|medicine.||
9306|105|P|   This drug may make you dizzy or drowsy or blur your vision.||
9306|106|P|Alcohol or marijuana (cannabis) can make you more dizzy or||
9306|107|P|drowsy. Do not drive, use machinery, or do anything that needs||
9306|108|P|alertness or clear vision until you can do it safely. Limit||
9306|109|P|alcoholic beverages. Talk to your doctor if you are using||
9306|110|P|marijuana (cannabis).||
9306|111|P|   Before having surgery, tell your doctor or dentist about all||
9306|112|P|the products you use (including prescription drugs,||
9306|113|P|nonprescription drugs, and herbal products).||
9306|114|P|   This drug may make you sweat less, making you more likely to||
9306|115|P|get heat stroke. Avoid doing things that may cause you to||
9306|116|P|overheat, such as hard work or exercise in hot weather, or using||
9306|117|P|hot tubs. When the weather is hot, drink a lot of fluids and||
9306|118|P|dress lightly. If you overheat, quickly look for a place to cool||
9306|119|P|down and rest. Get medical help right away if you have a fever||
9306|120|P|that does not go away, mental/mood changes, headache, or||
9306|121|P|dizziness.||
9306|122|P|   Older adults may be more sensitive to the side effects of this||
9306|123|P|drug, especially confusion, drowsiness, unusual excitement,||
9306|124|P|constipation, and difficulty urinating. Confusion and drowsiness||
9306|125|P|can increase the risk of falling.||
9306|126|P|   Children may be more sensitive to the side effects of this||
9306|127|P|drug.||
9306|128|P|   During pregnancy, hyoscyamine should be used only when clearly||
9306|129|P|needed. Discuss the risks and benefits with your doctor.||
9306|130|P|   This drug passes into breast milk. Consult your doctor before||
9306|131|P|breastfeeding.||
9306|132|B|||
9306|133|I|DRUG INTERACTIONS:  See also How to Use section.||
9306|134|I|   Drug interactions may change how your medications work or||
9306|135|I|increase your risk for serious side effects. This document does||
9306|136|I|not contain all possible drug interactions. Keep a list of all||
9306|137|I|the products you use (including prescription/nonprescription||
9306|138|I|drugs and herbal products) and share it with your doctor and||
9306|139|I|pharmacist. Do not start, stop, or change the dosage of any||
9306|140|I|medicines without your doctor's approval.||
9306|141|I|   Some products that may interact with this drug are: certain||
9306|142|I|azole anti-fungal drugs (ketoconazole, itraconazole),||
9306|143|I|bisphosphonate drugs (such as alendronate, risedronate),||
9306|144|I|corticosteroids (such as prednisone), digoxin (slow-dissolving||
9306|145|I|tablets), potassium tablets/capsules, pramlintide.||
9306|146|I|   Tell your doctor or pharmacist if you are taking other||
9306|147|I|products that cause drowsiness such as opioid pain or cough||
9306|148|I|relievers (such as codeine, hydrocodone), alcohol, marijuana||
9306|149|I|(cannabis), drugs for sleep or anxiety (such as alprazolam,||
9306|150|I|lorazepam, zolpidem), muscle relaxants (such as carisoprodol,||
9306|151|I|cyclobenzaprine), or antihistamines (such as cetirizine,||
9306|152|I|diphenhydramine).||
9306|153|I|   Check the labels on all your medicines (such as allergy or||
9306|154|I|cough-and-cold products) because they may contain ingredients||
9306|155|I|that cause drowsiness. Ask your pharmacist about using those||
9306|156|I|products safely.||
9306|157|I|   This medication may interfere with certain lab tests, possibly||
9306|158|I|causing false test results. Make sure lab personnel and all your||
9306|159|I|doctors know you use this drug.||
9306|160|B|||
9306|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9306|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9306|163|O|poison control center right away. US residents can call||
9306|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9306|165|O|Symptoms of overdose may include hot/dry skin, fever, unusual||
9306|166|O|excitement, fast/irregular heartbeat, seizures.||
9306|167|B|||
9306|168|N|NOTES:  Do not share this medication with others.||
9306|169|N|   Management of digestive disorders may include lifestyle||
9306|170|N|changes such as stress reduction programs, exercise, stopping||
9306|171|N|smoking, and dietary changes to increase the effectiveness of||
9306|172|N|this medicine. Talk to your doctor or pharmacist about lifestyle||
9306|173|N|changes that might benefit you.||
9306|174|B|||
9306|175|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9306|176|D|remember. If it is near the time of the next dose, skip the||
9306|177|D|missed dose. Take your next dose at the regular time. Do not||
9306|178|D|double the dose to catch up.||
9306|179|B|||
9306|180|R|STORAGE:  Store at room temperature away from light and moisture.||
9306|181|R|Do not store in the bathroom. Keep all medications away from||
9306|182|R|children and pets.||
9306|183|R|   Do not flush medications down the toilet or pour them into a||
9306|184|R|drain unless instructed to do so. Properly discard this product||
9306|185|R|when it is expired or no longer needed. Consult your pharmacist||
9306|186|R|or local waste disposal company.||
9306|187|B|||
9306|188|A|Information last revised October 2025.||
9306|189|A|Copyright(c) 2025 First Databank, Inc.||
9306|190|B|||
9309|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9309|002|Z|does NOT have all possible information about this product. This||
9309|003|Z|information does not assure that this product is safe, effective,||
9309|004|Z|or appropriate for you. This information is not individual||
9309|005|Z|medical advice and does not substitute for the advice of your||
9309|006|Z|health care professional. Always ask your health care||
9309|007|Z|professional for complete information about this product and your||
9309|008|Z|specific health needs.||
9309|009|B|||
9309|010|T|PIOGLITAZONE - ORAL||
9309|011|F|(PYE-oh-GLI-ta-zone)||
9309|012|B|||
9309|013|C|COMMON BRAND NAME(S): Actos||
9309|014|B|||
9309|015|W|WARNING:  Pioglitazone may rarely cause or worsen a certain heart||
9309|016|W|problem (heart failure). Tell your doctor right away if you||
9309|017|W|notice any symptoms of heart failure, including: shortness of||
9309|018|W|breath, swelling ankles/feet, unusual tiredness, unusual/sudden||
9309|019|W|weight gain.||
9309|020|W|   This medication is not recommended for people with certain||
9309|021|W|types of heart failure. Before using this medication, tell your||
9309|022|W|doctor if you have heart failure.||
9309|023|B|||
9309|024|U|USES:  Pioglitazone is a diabetes drug (thiazolidinedione-type,||
9309|025|U|also called "glitazones") used along with a proper diet and||
9309|026|U|exercise program to control high blood sugar in patients with||
9309|027|U|type 2 diabetes. It works by helping to restore your body's||
9309|028|U|proper response to insulin, thereby lowering your blood sugar.||
9309|029|U|   Controlling high blood sugar helps prevent kidney damage,||
9309|030|U|blindness, nerve problems, loss of limbs, and sexual function||
9309|031|U|problems. Proper control of diabetes may also lessen your risk of||
9309|032|U|a heart attack or stroke.||
9309|033|U|   Pioglitazone is used either alone or in combination with other||
9309|034|U|diabetes medications (such as metformin or a sulfonylurea such as||
9309|035|U|glyburide).||
9309|036|U|   Talk to your doctor about the risks and benefits of||
9309|037|U|pioglitazone.||
9309|038|B|||
9309|039|H|HOW TO USE:  Read the Medication Guide provided by your||
9309|040|H|pharmacist before you start using pioglitazone and each time you||
9309|041|H|get a refill. If you have any questions, ask your doctor or||
9309|042|H|pharmacist.||
9309|043|H|   Take this medication by mouth with or without food as directed||
9309|044|H|by your doctor, usually once daily. The dosage is based on your||
9309|045|H|medical condition, response to treatment, and other medications||
9309|046|H|you may be taking. Be sure to tell your doctor and pharmacist||
9309|047|H|about all the products you use (including prescription drugs,||
9309|048|H|nonprescription drugs, and herbal products).||
9309|049|H|   Take this medication regularly in order to get the most||
9309|050|H|benefit from it. To help you remember, take it at the same time||
9309|051|H|each day.||
9309|052|H|   It may take up to 2 to 3 months before the full benefit of||
9309|053|H|this drug takes effect. Tell your doctor if your condition does||
9309|054|H|not get better or if it gets worse (your blood sugar is too high||
9309|055|H|or too low).||
9309|056|B|||
9309|057|S|SIDE EFFECTS:  See also Warning section.||
9309|058|S|   Sore throat, muscle pain, weight gain, or tooth problems may||
9309|059|S|occur. If any of these effects last or get worse, tell your||
9309|060|S|doctor or pharmacist promptly.||
9309|061|S|   Remember that this medication has been prescribed because your||
9309|062|S|doctor has judged that the benefit to you is greater than the||
9309|063|S|risk of side effects. Many people using this medication do not||
9309|064|S|have serious side effects.||
9309|065|S|   Tell your doctor right away if you have any serious side||
9309|066|S|effects, including: new/worsening vision problems (such as||
9309|067|S|blurred vision), bone fracture, reddish-colored urine, urgent||
9309|068|S|need to urinate, pain while urinating, signs of liver disease||
9309|069|S|(such as nausea/vomiting that doesn't stop, dark urine, yellowing||
9309|070|S|eyes/skin, stomach/abdominal pain).||
9309|071|S|   Pioglitazone does not usually cause low blood sugar||
9309|072|S|(hypoglycemia). Low blood sugar may occur if this drug is||
9309|073|S|prescribed with other diabetes medications, or if you do not get||
9309|074|S|enough calories from food, or if you do unusually heavy exercise.||
9309|075|S|Talk with your doctor or pharmacist about whether the dose of||
9309|076|S|your other diabetes medication(s) needs to be lowered. Symptoms||
9309|077|S|of low blood sugar include sudden sweating, shaking, fast||
9309|078|S|heartbeat, hunger, blurred vision, dizziness, or tingling||
9309|079|S|hands/feet. It is a good habit to carry glucose tablets or gel to||
9309|080|S|treat low blood sugar. If you don't have these reliable forms of||
9309|081|S|glucose, rapidly raise your blood sugar by eating a quick source||
9309|082|S|of sugar such as table sugar, honey, or candy, or drink fruit||
9309|083|S|juice or non-diet soda. Tell your doctor right away about the||
9309|084|S|reaction and the use of this product. To help prevent low blood||
9309|085|S|sugar, eat meals on a regular schedule, and do not skip meals.||
9309|086|S|Check with your doctor or pharmacist to find out what you should||
9309|087|S|do if you miss a meal.||
9309|088|S|   Symptoms of high blood sugar (hyperglycemia) include increased||
9309|089|S|thirst/urination. If these symptoms occur, tell your doctor right||
9309|090|S|away. Your doctor may need to adjust your diabetes medication,||
9309|091|S|exercise program, or diet.||
9309|092|S|   A very serious allergic reaction to this drug is rare.||
9309|093|S|However, get medical help right away if you notice any symptoms||
9309|094|S|of a serious allergic reaction, including: rash, itching/swelling||
9309|095|S|(especially of the face/tongue/throat), dizziness, trouble||
9309|096|S|breathing.||
9309|097|S|   This is not a complete list of possible side effects. If you||
9309|098|S|notice other effects not listed above, contact your doctor or||
9309|099|S|pharmacist.||
9309|100|S|   In the US -||
9309|101|S|   Call your doctor for medical advice about side effects. You||
9309|102|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9309|103|S|www.fda.gov/medwatch.||
9309|104|S|   In Canada - Call your doctor for medical advice about side||
9309|105|S|effects. You may report side effects to Health Canada at||
9309|106|S|1-866-234-2345.||
9309|107|B|||
9309|108|P|PRECAUTIONS:  Before taking pioglitazone, tell your doctor or||
9309|109|P|pharmacist if you are allergic to it; or if you have any other||
9309|110|P|allergies. This product may contain inactive ingredients, which||
9309|111|P|can cause allergic reactions or other problems. Talk to your||
9309|112|P|pharmacist for more details.||
9309|113|P|   Before using this medication, tell your doctor or pharmacist||
9309|114|P|your medical history, especially of: heart disease (such as heart||
9309|115|P|failure, chest pain), liver disease, fluid in your lungs,||
9309|116|P|swelling (edema), anemia, a certain eye problem (macular edema),||
9309|117|P|bladder cancer.||
9309|118|P|   You may experience blurred vision, dizziness, or drowsiness||
9309|119|P|due to extremely low or high blood sugar. Do not drive, use||
9309|120|P|machinery, or do anything that needs alertness or clear vision||
9309|121|P|until you can do it safely.||
9309|122|P|   Limit alcohol while taking this medication because it can||
9309|123|P|increase the risk of developing low blood sugar.||
9309|124|P|   It may be harder to control your blood sugar when your body is||
9309|125|P|stressed (such as due to fever, infection, injury, or surgery).||
9309|126|P|Consult your doctor because increased stress may require a change||
9309|127|P|in your treatment plan, medications, or blood sugar testing.||
9309|128|P|   Before having surgery, tell your doctor or dentist about all||
9309|129|P|the products you use (including prescription drugs,||
9309|130|P|nonprescription drugs, and herbal products).||
9309|131|P|   Pioglitazone may increase the risk of bone fracture in women||
9309|132|P|(usually in the upper arm, hand, or foot). See also Notes||
9309|133|P|section.||
9309|134|P|   Pioglitazone can cause changes in the menstrual cycle (promote||
9309|135|P|ovulation) and increase the risk of becoming pregnant. Consult||
9309|136|P|your doctor or pharmacist about the use of reliable birth control||
9309|137|P|while using this medication.||
9309|138|P|   During pregnancy, this medication should be used only when||
9309|139|P|clearly needed. Discuss the risks and benefits with your doctor.||
9309|140|P|   Pregnancy may cause or worsen diabetes. Discuss a plan with||
9309|141|P|your doctor for managing your blood sugar while pregnant. Your||
9309|142|P|doctor may change your diabetes treatment during your pregnancy||
9309|143|P|(such as diet and medications including insulin).||
9309|144|P|   It is unknown if this drug passes into breast milk. Consult||
9309|145|P|your doctor before breastfeeding.||
9309|146|B|||
9309|147|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9309|148|I|medications work or increase your risk for serious side effects.||
9309|149|I|This document does not contain all possible drug interactions.||
9309|150|I|Keep a list of all the products you use (including||
9309|151|I|prescription/nonprescription drugs and herbal products) and share||
9309|152|I|it with your doctor and pharmacist. Do not start, stop, or change||
9309|153|I|the dosage of any medicines without your doctor's approval.||
9309|154|I|   Beta-blocker medications (such as metoprolol, propranolol,||
9309|155|I|glaucoma eye drops such as timolol) may prevent the fast/pounding||
9309|156|I|heartbeat you would usually feel when your blood sugar falls too||
9309|157|I|low (hypoglycemia). Other symptoms of low blood sugar, such as||
9309|158|I|dizziness, hunger, or sweating, are unaffected by these drugs.||
9309|159|I|   Many drugs can affect your blood sugar, making it harder to||
9309|160|I|control. Before you start, stop, or change any medication, talk||
9309|161|I|with your doctor or pharmacist about how the medication may||
9309|162|I|affect your blood sugar. Check your blood sugar regularly as||
9309|163|I|directed and share the results with your doctor. Tell your doctor||
9309|164|I|right away if you have symptoms of high or low blood sugar. (See||
9309|165|I|also Side Effects section.) Your doctor may need to adjust your||
9309|166|I|diabetes medication, exercise program, or diet.||
9309|167|B|||
9309|168|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9309|169|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9309|170|O|poison control center right away. US residents can call||
9309|171|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9309|172|B|||
9309|173|N|NOTES:  Do not share this medication with others.||
9309|174|N|   Attend a diabetes education program to learn more about how to||
9309|175|N|manage your diabetes with medications, diet, exercise, and||
9309|176|N|regular medical exams.||
9309|177|N|   Learn the symptoms of high and low blood sugar and how to||
9309|178|N|treat low blood sugar. Check your blood sugar regularly as||
9309|179|N|directed and share the results with your doctor.||
9309|180|N|   Lifestyle changes that help promote healthy bones include||
9309|181|N|increasing weight-bearing exercise, eating well-balanced meals||
9309|182|N|containing adequate calcium and vitamin D, stopping smoking, and||
9309|183|N|limiting alcohol. Consult your doctor to see if you need to take||
9309|184|N|calcium/vitamin D supplements and discuss lifestyle changes that||
9309|185|N|might benefit you.||
9309|186|N|   Lab and/or medical tests (such as liver function, blood||
9309|187|N|glucose, hemoglobin A1c, complete blood counts, eye exams) should||
9309|188|N|be done while you are taking this medication. Keep all medical||
9309|189|N|and lab appointments.||
9309|190|B|||
9309|191|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9309|192|D|If it is near the time of the next dose, skip the missed dose.||
9309|193|D|Use your next dose at the regular time. Do not double the dose to||
9309|194|D|catch up.||
9309|195|B|||
9309|196|R|STORAGE:  Store at room temperature away from light and moisture.||
9309|197|R|Do not store in the bathroom. Keep all medications away from||
9309|198|R|children and pets.||
9309|199|R|   Do not flush medications down the toilet or pour them into a||
9309|200|R|drain unless instructed to do so. Properly discard this product||
9309|201|R|when it is expired or no longer needed. Consult your pharmacist||
9309|202|R|or local waste disposal company.||
9309|203|B|||
9309|204|M|MEDICAL ALERT:  Your condition can cause complications in a||
9309|205|M|medical emergency. For information about enrolling in MedicAlert,||
9309|206|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9309|207|B|||
9309|208|A|Information last revised November 2025.||
9309|209|A|Copyright(c) 2025 First Databank, Inc.||
9309|210|B|||
9310|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9310|002|Z|does NOT have all possible information about this product. This||
9310|003|Z|information does not assure that this product is safe, effective,||
9310|004|Z|or appropriate for you. This information is not individual||
9310|005|Z|medical advice and does not substitute for the advice of your||
9310|006|Z|health care professional. Always ask your health care||
9310|007|Z|professional for complete information about this product and your||
9310|008|Z|specific health needs.||
9310|009|B|||
9310|010|T|ALENDRONATE 40 MG - ORAL||
9310|011|F|(a-LEN-droe-nate)||
9310|012|B|||
9310|013|C|COMMON BRAND NAME(S): Fosamax||
9310|014|B|||
9310|015|U|USES:  Alendronate is used to treat a certain type of bone||
9310|016|U|disease called Paget's disease. This disease weakens and deforms||
9310|017|U|bones. Alendronate works by slowing bone loss, helping to keep||
9310|018|U|your bones strong and less likely to break. It also helps reduce||
9310|019|U|bone pain from this disease. This medication belongs to a class||
9310|020|U|of drugs called bisphosphonates.||
9310|021|B|||
9310|022|V|OTHER USES:  This section contains uses of this drug that are not||
9310|023|V|listed in the approved professional labeling for the drug but||
9310|024|V|that may be prescribed by your health care professional. Use this||
9310|025|V|drug for a condition that is listed in this section only if it||
9310|026|V|has been so prescribed by your health care professional.||
9310|027|V|   This drug may also be used for bone loss (osteoporosis) in||
9310|028|V|adults. Osteoporosis causes bones to become thinner and break||
9310|029|V|more easily. Your chance of getting osteoporosis goes up as you||
9310|030|V|age, after menopause, or if you are taking corticosteroid||
9310|031|V|medications (such as prednisone) for a long time.||
9310|032|B|||
9310|033|H|HOW TO USE:  Read the Medication Guide provided by your||
9310|034|H|pharmacist before you start taking alendronate and each time you||
9310|035|H|get a refill. Follow the instructions very closely to make sure||
9310|036|H|your body absorbs as much drug as possible and to reduce the risk||
9310|037|H|of injury to your esophagus. If you have any questions, ask your||
9310|038|H|doctor or pharmacist.||
9310|039|H|   Take this medication by mouth as directed by your doctor,||
9310|040|H|usually once a day. Take this medication after getting up for the||
9310|041|H|day and before taking your first food, beverage, or other||
9310|042|H|medication. Take it with a full glass (6-8 ounces or 180-240||
9310|043|H|milliliters) of plain water. Swallow the tablet whole. Do not||
9310|044|H|chew or suck on it. Then stay fully upright (sitting, standing,||
9310|045|H|or walking) for at least 30 minutes and do not lie down until||
9310|046|H|after your first food of the day. Alendronate works only if taken||
9310|047|H|on an empty stomach. Wait at least 30 minutes (preferably 1 to 2||
9310|048|H|hours) after taking the medication before you eat or drink||
9310|049|H|anything other than plain water.||
9310|050|H|   Do not take this medication at bedtime or before rising for||
9310|051|H|the day. It may not be absorbed and you may have side effects.||
9310|052|H|   Calcium or iron supplements, vitamins, antacids, coffee, tea,||
9310|053|H|soda, mineral water, juice with added calcium, and food can||
9310|054|H|decrease the absorption of alendronate. Do not take these for at||
9310|055|H|least 30 minutes (preferably 1 to 2 hours) after taking||
9310|056|H|alendronate.||
9310|057|H|   Take this medication regularly to get the most benefit from||
9310|058|H|it. For the treatment of Paget's disease, remember to take it at||
9310|059|H|the same time each morning, usually for 6 months.||
9310|060|H|   This drug may also be prescribed once weekly for osteoporosis.||
9310|061|H|Check your prescription label carefully, and ask your doctor or||
9310|062|H|pharmacist if you are not sure how to take this medication. Talk||
9310|063|H|to your doctor about the risks and benefits of long-term use of||
9310|064|H|this medication.||
9310|065|B|||
9310|066|S|SIDE EFFECTS:  Stomach pain, constipation, diarrhea, gas, or||
9310|067|S|nausea may occur. If any of these effects last or get worse, tell||
9310|068|S|your doctor or pharmacist promptly.||
9310|069|S|   Remember that this medication has been prescribed because your||
9310|070|S|doctor has judged that the benefit to you is greater than the||
9310|071|S|risk of side effects. Many people using this medication do not||
9310|072|S|have serious side effects.||
9310|073|S|   Tell your doctor right away if you have any serious side||
9310|074|S|effects, including: jaw/ear pain, swelling of||
9310|075|S|joints/hands/ankles/feet, increased or severe bone/joint/muscle||
9310|076|S|pain, new or unusual hip/thigh/groin pain, black/tarry stools,||
9310|077|S|vomit that looks like coffee grounds.||
9310|078|S|   This medication may rarely cause serious irritation and ulcers||
9310|079|S|of the esophagus. If you notice any of the following unlikely but||
9310|080|S|very serious side effects, stop taking alendronate and talk to||
9310|081|S|your doctor or pharmacist right away: new or worsening heartburn,||
9310|082|S|chest pain, pain or difficulty when swallowing.||
9310|083|S|   A very serious allergic reaction to this drug is rare.||
9310|084|S|However, get medical help right away if you notice any symptoms||
9310|085|S|of a serious allergic reaction, including: rash, itching/swelling||
9310|086|S|(especially of the face/tongue/throat), dizziness, trouble||
9310|087|S|breathing.||
9310|088|S|   This is not a complete list of possible side effects. If you||
9310|089|S|notice other effects not listed above, contact your doctor or||
9310|090|S|pharmacist.||
9310|091|S|   In the US -||
9310|092|S|   Call your doctor for medical advice about side effects. You||
9310|093|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9310|094|S|www.fda.gov/medwatch.||
9310|095|S|   In Canada - Call your doctor for medical advice about side||
9310|096|S|effects. You may report side effects to Health Canada at||
9310|097|S|1-866-234-2345.||
9310|098|B|||
9310|099|P|PRECAUTIONS:  Before taking alendronate, tell your doctor or||
9310|100|P|pharmacist if you are allergic to it; or to other||
9310|101|P|bisphosphonates; or if you have any other allergies. This product||
9310|102|P|may contain inactive ingredients, which can cause allergic||
9310|103|P|reactions or other problems. Talk to your pharmacist for more||
9310|104|P|details.||
9310|105|P|   Before using this medication, tell your doctor or pharmacist||
9310|106|P|your medical history, especially of: disorders of the esophagus||
9310|107|P|(such as esophageal stricture or achalasia), trouble swallowing,||
9310|108|P|trouble standing or sitting upright for at least 30 minutes, low||
9310|109|P|calcium levels, kidney problems, stomach/intestinal disorders||
9310|110|P|(such as ulcers).||
9310|111|P|   Some people taking alendronate may have serious jawbone||
9310|112|P|problems. Your doctor should check your mouth before you start||
9310|113|P|this medication. Tell your dentist that you are taking this||
9310|114|P|medication before you have any dental work done. To help prevent||
9310|115|P|jawbone problems, have regular dental exams and learn how to keep||
9310|116|P|your teeth and gums healthy. If you have jaw pain, tell your||
9310|117|P|doctor and dentist right away.||
9310|118|P|   Before having any surgery (especially dental procedures), tell||
9310|119|P|your doctor and dentist about this medication and all other||
9310|120|P|products you use (including prescription drugs, nonprescription||
9310|121|P|drugs, and herbal products). Your doctor or dentist may tell you||
9310|122|P|to stop taking alendronate before your surgery. Follow all||
9310|123|P|instructions about stopping or starting this medication.||
9310|124|P|   This drug is not recommended for use in children. Studies have||
9310|125|P|shown that many children who took this drug had severe side||
9310|126|P|effects such as vomiting, fever, and flu-like symptoms.||
9310|127|P|   Tell your doctor if you are pregnant or plan to become||
9310|128|P|pregnant. Alendronate may stay in your body for many years. You||
9310|129|P|should not become pregnant while using alendronate. Discuss the||
9310|130|P|risks and benefits with your doctor.||
9310|131|P|   It is unknown if this medication passes into breast milk.||
9310|132|P|Consult your doctor before breastfeeding.||
9310|133|B|||
9310|134|I|DRUG INTERACTIONS:  See also How to Use section.||
9310|135|I|   Drug interactions may change how your medications work or||
9310|136|I|increase your risk for serious side effects. This document does||
9310|137|I|not contain all possible drug interactions. Keep a list of all||
9310|138|I|the products you use (including prescription/nonprescription||
9310|139|I|drugs and herbal products) and share it with your doctor and||
9310|140|I|pharmacist. Do not start, stop, or change the dosage of any||
9310|141|I|medicines without your doctor's approval.||
9310|142|B|||
9310|143|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9310|144|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9310|145|O|poison control center right away. US residents can call||
9310|146|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9310|147|O|Symptoms of overdose may include: severe stomach pain, painful||
9310|148|O|heartburn, pain in the esophagus (chest pain), muscle||
9310|149|O|weakness/cramps, mental/mood changes.||
9310|150|B|||
9310|151|N|NOTES:  Do not share this medication with others.||
9310|152|N|   Lifestyle changes that help promote healthy bones include||
9310|153|N|increasing weight-bearing exercise, stopping smoking, limiting||
9310|154|N|alcohol, and eating well-balanced meals that contain adequate||
9310|155|N|calcium and vitamin D. You may also need to take calcium and||
9310|156|N|vitamin D supplements. Consult your doctor for specific advice.||
9310|157|N|   Lab and/or medical tests (X-rays, height measurement, blood||
9310|158|N|mineral levels) should be done while you are taking this||
9310|159|N|medication. Keep all medical and lab appointments. Consult your||
9310|160|N|doctor for more details.||
9310|161|B|||
9310|162|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
9310|163|D|next dose at the regular time the following day. Do not take two||
9310|164|D|doses on the same day.||
9310|165|B|||
9310|166|R|STORAGE:  Store at room temperature away from light and moisture.||
9310|167|R|Do not store in the bathroom. Keep all medications away from||
9310|168|R|children and pets.||
9310|169|R|   Do not flush medications down the toilet or pour them into a||
9310|170|R|drain unless instructed to do so. Properly discard this product||
9310|171|R|when it is expired or no longer needed. Consult your pharmacist||
9310|172|R|or local waste disposal company.||
9310|173|B|||
9310|174|A|Information last revised September 2025.||
9310|175|A|Copyright(c) 2025 First Databank, Inc.||
9310|176|B|||
9311|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9311|002|Z|does NOT have all possible information about this product. This||
9311|003|Z|information does not assure that this product is safe, effective,||
9311|004|Z|or appropriate for you. This information is not individual||
9311|005|Z|medical advice and does not substitute for the advice of your||
9311|006|Z|health care professional. Always ask your health care||
9311|007|Z|professional for complete information about this product and your||
9311|008|Z|specific health needs.||
9311|009|B|||
9311|010|T|GINGER (Zingiber officinale) - ORAL||
9311|011|B|||
9311|012|U|USES:  Ginger has been used for stomach upset, motion sickness,||
9311|013|U|nausea, and vomiting.||
9311|014|U|   Some herbal/diet supplement products have been found to||
9311|015|U|contain possibly harmful impurities/additives. Check with your||
9311|016|U|pharmacist for more details about the particular brand you use.||
9311|017|U|   The FDA has not reviewed this product for safety or||
9311|018|U|effectiveness. Consult your doctor or pharmacist for more||
9311|019|U|details.||
9311|020|B|||
9311|021|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
9311|022|H|directions on the product package. If you have any questions, ask||
9311|023|H|your doctor or pharmacist.||
9311|024|H|   If your condition lasts or gets worse, or if you think you may||
9311|025|H|have a serious medical problem, get medical help right away.||
9311|026|B|||
9311|027|S|SIDE EFFECTS:  Burning feeling in mouth/throat, abdominal pain,||
9311|028|S|diarrhea, or heartburn may occur. If any of these effects last or||
9311|029|S|get worse, tell your doctor or pharmacist promptly.||
9311|030|S|   Tell your doctor right away if you have any serious side||
9311|031|S|effects, including: unusual bleeding/bruising, unusual||
9311|032|S|drowsiness, irregular heartbeat.||
9311|033|S|   A very serious allergic reaction to this product is rare.||
9311|034|S|However, get medical help right away if you notice any symptoms||
9311|035|S|of a serious allergic reaction, including: rash, itching/swelling||
9311|036|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9311|037|S|breathing.||
9311|038|S|   This is not a complete list of possible side effects. If you||
9311|039|S|notice other effects not listed above, contact your doctor or||
9311|040|S|pharmacist.||
9311|041|S|   In the US -||
9311|042|S|   Call your doctor for medical advice about side effects. You||
9311|043|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9311|044|S|www.fda.gov/medwatch.||
9311|045|S|   In Canada - Call your doctor for medical advice about side||
9311|046|S|effects. You may report side effects to Health Canada at||
9311|047|S|1-866-234-2345.||
9311|048|B|||
9311|049|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
9311|050|P|pharmacist if you are allergic to it; or if you have any other||
9311|051|P|allergies. This product may contain inactive ingredients, which||
9311|052|P|can cause allergic reactions or other problems. Talk to your||
9311|053|P|pharmacist for more details.||
9311|054|P|   If you have any of the following health problems, consult your||
9311|055|P|doctor or pharmacist before using this product: bleeding||
9311|056|P|problems, diabetes, gallstones, heart problems.||
9311|057|P|   This product might contain aristolochic acid, which can cause||
9311|058|P|serious problems in the kidneys or urinary system (such as renal||
9311|059|P|fibrosis, urinary tract cancer). Symptoms include a change in the||
9311|060|P|amount of urine or blood in the urine. Consult your pharmacist||
9311|061|P|for more details about the contents of this ginger product.||
9311|062|P|   Liquid products or chewable tablets may contain sugar and/or||
9311|063|P|aspartame. Liquid products may also contain alcohol. Caution is||
9311|064|P|advised if you have diabetes, liver disease, phenylketonuria||
9311|065|P|(PKU), or any other condition that requires you to limit/avoid||
9311|066|P|these substances in your diet. Ask your doctor or pharmacist||
9311|067|P|about using this product safely.||
9311|068|P|   Before having surgery, tell your doctor or dentist about all||
9311|069|P|the products you use (including prescription drugs,||
9311|070|P|nonprescription drugs, and herbal products).||
9311|071|P|   During pregnancy, this product should be used only when||
9311|072|P|clearly needed. Discuss the risks and benefits with your doctor.||
9311|073|P|   It is unknown if this product passes into breast milk. Consult||
9311|074|P|your doctor before breastfeeding.||
9311|075|B|||
9311|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9311|077|I|medications work or increase your risk for serious side effects.||
9311|078|I|This document does not contain all possible drug interactions.||
9311|079|I|Keep a list of all the products you use (including||
9311|080|I|prescription/nonprescription drugs and herbal products) and share||
9311|081|I|it with your doctor and pharmacist. Do not start, stop, or change||
9311|082|I|the dosage of any medicines without your doctor's approval.||
9311|083|I|   Some drugs that may interact with this product are:||
9311|084|I|medications/herbal products that may increase your risk of||
9311|085|I|bleeding (including "blood thinners" such as warfarin and||
9311|086|I|heparin, anti-platelet drugs such as clopidogrel, herbs such as||
9311|087|I|danshen/garlic).||
9311|088|I|   Aspirin may also increase the risk of bleeding when used with||
9311|089|I|this product. If your doctor has prescribed low doses of aspirin||
9311|090|I|to prevent heart attack or stroke (usually 81-162 milligrams a||
9311|091|I|day), you should continue to take the aspirin. Consult your||
9311|092|I|doctor or pharmacist for more details.||
9311|093|B|||
9311|094|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9311|095|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9311|096|O|poison control center right away. US residents can call||
9311|097|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9311|098|B|||
9311|099|N|NOTES:  Keep all medical and lab appointments.||
9311|100|B|||
9311|101|D|MISSED DOSE:  If you are taking this product on a regular||
9311|102|D|schedule and miss a dose, take it as soon as you remember. If it||
9311|103|D|is near the time of the next dose, skip the missed dose. Take||
9311|104|D|your next dose at the regular time. Do not double the dose to||
9311|105|D|catch up.||
9311|106|B|||
9311|107|R|STORAGE:  Refer to storage information printed on the package. If||
9311|108|R|you have any questions about storage, ask your pharmacist. Keep||
9311|109|R|all medications and herbal products away from children and pets.||
9311|110|R|   Do not flush medications down the toilet or pour them into a||
9311|111|R|drain unless instructed to do so. Properly discard this product||
9311|112|R|when it is expired or no longer needed. Consult your pharmacist||
9311|113|R|or local waste disposal company.||
9311|114|B|||
9311|115|A|Information last revised April 2025.||
9311|116|A|Copyright(c) 2025 First Databank, Inc.||
9311|117|B|||
9312|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9312|002|Z|does NOT have all possible information about this product. This||
9312|003|Z|information does not assure that this product is safe, effective,||
9312|004|Z|or appropriate for you. This information is not individual||
9312|005|Z|medical advice and does not substitute for the advice of your||
9312|006|Z|health care professional. Always ask your health care||
9312|007|Z|professional for complete information about this product and your||
9312|008|Z|specific health needs.||
9312|009|B|||
9312|010|T|SAW PALMETTO (Serenoa repens) - ORAL||
9312|011|B|||
9312|012|U|USES:  Saw palmetto has been used in men for urination problems||
9312|013|U|(such as decreased urine flow, nighttime/frequent urination) due||
9312|014|U|to an enlarged prostate gland (benign prostatic hyperplasia-BPH).||
9312|015|U|   Some herbal/diet supplement products have been found to||
9312|016|U|contain possibly harmful impurities/additives. Check with your||
9312|017|U|pharmacist for more details about the brand you use.||
9312|018|U|   The FDA has not reviewed this product for safety or||
9312|019|U|effectiveness. Consult your doctor or pharmacist for more||
9312|020|U|details.||
9312|021|B|||
9312|022|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
9312|023|H|directions on the product package. If you have any questions, ask||
9312|024|H|your doctor or pharmacist.||
9312|025|H|   If your condition lasts or gets worse, or if you think you may||
9312|026|H|have a serious medical problem, get medical help right away.||
9312|027|B|||
9312|028|S|SIDE EFFECTS:  Nausea, diarrhea, dizziness, or headache may||
9312|029|S|occur. If any of these effects last or get worse, tell your||
9312|030|S|doctor or pharmacist promptly.||
9312|031|S|   Tell your doctor right away if you have any serious side||
9312|032|S|effects, including: easy bleeding/bruising, decreased sexual||
9312|033|S|ability, severe nausea/vomiting, severe abdominal/stomach pain,||
9312|034|S|unusual tiredness, dark urine, yellowing eyes/skin.||
9312|035|S|   A very serious allergic reaction to this product is rare.||
9312|036|S|However, get medical help right away if you notice any symptoms||
9312|037|S|of a serious allergic reaction, including: rash, itching/swelling||
9312|038|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9312|039|S|breathing.||
9312|040|S|   This is not a complete list of possible side effects. If you||
9312|041|S|notice other effects not listed above, contact your doctor or||
9312|042|S|pharmacist.||
9312|043|S|   In the US -||
9312|044|S|   Call your doctor for medical advice about side effects. You||
9312|045|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9312|046|S|www.fda.gov/medwatch.||
9312|047|S|   In Canada - Call your doctor for medical advice about side||
9312|048|S|effects. You may report side effects to Health Canada at||
9312|049|S|1-866-234-2345.||
9312|050|B|||
9312|051|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
9312|052|P|pharmacist if you are allergic to it; or if you have any other||
9312|053|P|allergies. This product may contain inactive ingredients, which||
9312|054|P|can cause allergic reactions or other problems. Talk to your||
9312|055|P|pharmacist for more details.||
9312|056|P|   If you have any of the following health problems, consult your||
9312|057|P|doctor or pharmacist before using this product: bleeding||
9312|058|P|problems.||
9312|059|P|   Before having surgery, tell your doctor or dentist about all||
9312|060|P|the products you use (including prescription drugs,||
9312|061|P|nonprescription drugs, and herbal products). Saw palmetto may||
9312|062|P|decrease the ability of blood to clot. Stop taking this product||
9312|063|P|at least 2 weeks before your surgery unless otherwise directed by||
9312|064|P|your doctor. Ask your doctor when it is safe to start using this||
9312|065|P|product after your surgery.||
9312|066|P|   Liquid forms of this product may contain sugar and/or alcohol.||
9312|067|P|Caution is advised if you have diabetes, alcohol dependence, or||
9312|068|P|liver disease. Ask your doctor or pharmacist about using this||
9312|069|P|product safely.||
9312|070|P|   Saw palmetto is not recommended for use during pregnancy.||
9312|071|P|Consult your doctor before using this product.||
9312|072|P|   It is unknown if this product passes into breast milk, but it||
9312|073|P|may have undesirable effects on a nursing infant. Consult your||
9312|074|P|doctor before breastfeeding.||
9312|075|B|||
9312|076|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9312|077|I|medications work or increase your risk for serious side effects.||
9312|078|I|This document does not contain all possible drug interactions.||
9312|079|I|Keep a list of all the products you use (including||
9312|080|I|prescription/nonprescription drugs and herbal products) and share||
9312|081|I|it with your doctor and pharmacist. Do not start, stop, or change||
9312|082|I|the dosage of any medicines without your doctor's approval.||
9312|083|I|   Some drugs that may interact with this product include:||
9312|084|I|estrogens, medications/herbal products that may increase your||
9312|085|I|risk of bleeding (including "blood thinners" such as warfarin and||
9312|086|I|heparin, anti-platelet drugs such as clopidogrel, herbs such as||
9312|087|I|danshen/garlic/ginger/ginkgo).||
9312|088|I|   Aspirin may also increase the risk of bleeding when used with||
9312|089|I|this product. If your doctor has prescribed low doses of aspirin||
9312|090|I|to prevent heart attack or stroke (usually 81-162 milligrams a||
9312|091|I|day), you should continue to take the aspirin. Consult your||
9312|092|I|doctor or pharmacist for more details.||
9312|093|B|||
9312|094|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9312|095|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9312|096|O|poison control center right away. US residents can call||
9312|097|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9312|098|B|||
9312|099|N|NOTES:  Keep all medical and lab test appointments.||
9312|100|B|||
9312|101|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9312|102|D|If it is near the time of the next dose, skip the missed dose.||
9312|103|D|Use your next dose at the regular time. Do not double the dose to||
9312|104|D|catch up.||
9312|105|B|||
9312|106|R|STORAGE:  Refer to storage information printed on the package. If||
9312|107|R|you have any questions about storage, ask your pharmacist. Keep||
9312|108|R|all medications and herbal products away from children and pets.||
9312|109|R|   Do not flush medications down the toilet or pour them into a||
9312|110|R|drain unless instructed to do so. Properly discard this product||
9312|111|R|when it is expired or no longer needed. Consult your pharmacist||
9312|112|R|or local waste disposal company.||
9312|113|B|||
9312|114|A|Information last revised April 2025.||
9312|115|A|Copyright(c) 2025 First Databank, Inc.||
9312|116|B|||
9315|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9315|002|Z|does NOT have all possible information about this product. This||
9315|003|Z|information does not assure that this product is safe, effective,||
9315|004|Z|or appropriate for you. This information is not individual||
9315|005|Z|medical advice and does not substitute for the advice of your||
9315|006|Z|health care professional. Always ask your health care||
9315|007|Z|professional for complete information about this product and your||
9315|008|Z|specific health needs.||
9315|009|B|||
9315|010|T|BILBERRY FRUIT (Myrtilli fructus) - ORAL||
9315|011|B|||
9315|012|U|USES:  Bilberry fruit has been used for diarrhea, for soothing||
9315|013|U|the mouth and throat, and for improving vision.||
9315|014|U|   Some herbal/dietary supplement products have been found to||
9315|015|U|contain possibly harmful impurities/additives. Check with your||
9315|016|U|pharmacist for more details about the brand you use.||
9315|017|U|   The FDA has not reviewed this product for safety or||
9315|018|U|effectiveness. Consult your doctor or pharmacist for more||
9315|019|U|details.||
9315|020|B|||
9315|021|H|HOW TO USE:  Take this product by mouth as directed. Follow all||
9315|022|H|directions on the product package. If you have any questions, ask||
9315|023|H|your doctor or pharmacist.||
9315|024|H|   Consult your doctor if you are using this product for diarrhea||
9315|025|H|and your diarrhea last more than 3 to 4 days.||
9315|026|H|   If your condition lasts or gets worse, or if you think you may||
9315|027|H|have a serious medical problem, get medical help right away.||
9315|028|B|||
9315|029|S|SIDE EFFECTS:  A very serious allergic reaction to this product||
9315|030|S|is rare. However, get medical help right away if you notice any||
9315|031|S|symptoms of a serious allergic reaction, including: rash,||
9315|032|S|itching/swelling (especially of the face/tongue/throat), severe||
9315|033|S|dizziness, trouble breathing.||
9315|034|S|   This is not a complete list of possible side effects. If you||
9315|035|S|notice other effects not listed above, contact your doctor or||
9315|036|S|pharmacist.||
9315|037|S|   In the US -||
9315|038|S|   Call your doctor for medical advice about side effects. You||
9315|039|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9315|040|S|www.fda.gov/medwatch.||
9315|041|S|   In Canada - Call your doctor for medical advice about side||
9315|042|S|effects. You may report side effects to Health Canada at||
9315|043|S|1-866-234-2345.||
9315|044|B|||
9315|045|P|PRECAUTIONS:  Before taking bilberry, tell your doctor or||
9315|046|P|pharmacist if you are allergic to it; or if you have any other||
9315|047|P|allergies. This product may contain inactive ingredients, which||
9315|048|P|can cause allergic reactions or other problems. Talk to your||
9315|049|P|pharmacist for more details.||
9315|050|P|   Liquid forms of this product may contain sugar and/or alcohol.||
9315|051|P|Caution is advised if you have diabetes, alcohol dependence, or||
9315|052|P|liver disease. Ask your doctor or pharmacist about using this||
9315|053|P|product safely.||
9315|054|P|   During pregnancy, this product should be used only when||
9315|055|P|clearly needed. Discuss the risks and benefits with your doctor.||
9315|056|P|   It is unknown if this product passes into breast milk. Consult||
9315|057|P|your doctor before breastfeeding.||
9315|058|B|||
9315|059|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9315|060|I|medications work or increase your risk for serious side effects.||
9315|061|I|This document does not contain all possible drug interactions.||
9315|062|I|Keep a list of all the products you use (including||
9315|063|I|prescription/nonprescription drugs and herbal products) and share||
9315|064|I|it with your doctor and pharmacist. Do not start, stop, or change||
9315|065|I|the dosage of any medicines without your doctor's approval.||
9315|066|B|||
9315|067|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9315|068|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9315|069|O|poison control center right away. US residents can call||
9315|070|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9315|071|B|||
9315|072|N|NOTES:  Keep all medical and lab test appointments.||
9315|073|B|||
9315|074|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9315|075|D|If it is near the time of the next dose, skip the missed dose.||
9315|076|D|Use your next dose at the regular time. Do not double the dose to||
9315|077|D|catch up.||
9315|078|B|||
9315|079|R|STORAGE:  Refer to storage information printed on the package. If||
9315|080|R|you have any questions about storage, ask your pharmacist. Keep||
9315|081|R|all medications and herbal products away from children and pets.||
9315|082|R|   Do not flush medications down the toilet or pour them into a||
9315|083|R|drain unless instructed to do so. Properly discard this product||
9315|084|R|when it is expired or no longer needed. Consult your pharmacist||
9315|085|R|or local waste disposal company.||
9315|086|B|||
9315|087|A|Information last revised May 2024.||
9315|088|A|Copyright(c) 2025 First Databank, Inc.||
9315|089|B|||
9316|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9316|002|Z|does NOT have all possible information about this product. This||
9316|003|Z|information does not assure that this product is safe, effective,||
9316|004|Z|or appropriate for you. This information is not individual||
9316|005|Z|medical advice and does not substitute for the advice of your||
9316|006|Z|health care professional. Always ask your health care||
9316|007|Z|professional for complete information about this product and your||
9316|008|Z|specific health needs.||
9316|009|B|||
9316|010|T|FLAXSEED (Linum usitatissimum) - ORAL||
9316|011|B|||
9316|012|U|USES:  Flaxseed has been used for constipation. It has also been||
9316|013|U|used for controlling levels of cholesterol and blood sugar in the||
9316|014|U|body.||
9316|015|U|   Some herbal/diet supplement products have been found to||
9316|016|U|contain possibly harmful impurities/additives. Check with your||
9316|017|U|pharmacist for more details about your brand.||
9316|018|U|   The FDA has not reviewed this product for safety or||
9316|019|U|effectiveness. Consult your doctor or pharmacist for more||
9316|020|U|details.||
9316|021|B|||
9316|022|H|HOW TO USE:  Take this product by mouth as directed. Flaxseed may||
9316|023|H|change the way your body absorbs other medicines taken by mouth.||
9316|024|H|Take flaxseed at least 1 to 2 hours before or after the time(s)||
9316|025|H|you usually take other medicines.||
9316|026|H|   Follow all directions on the product package. If you have any||
9316|027|H|questions, ask your doctor or pharmacist.||
9316|028|H|   If you are using the liquid form of this medication, shake the||
9316|029|H|bottle well before each dose. Carefully measure the dose using a||
9316|030|H|special measuring device/spoon. Do not use a household spoon||
9316|031|H|because you may not get the correct dose.||
9316|032|H|   Drink plenty of water while using this product.||
9316|033|H|   Do not use this product for constipation for more than 7 days||
9316|034|H|unless directed by your doctor. Do not use this product if you||
9316|035|H|have had bowel problems for longer than 2 weeks or if there is||
9316|036|H|blood in your stool. Consult your doctor or pharmacist.||
9316|037|H|   If your condition lasts or gets worse, or if you think you may||
9316|038|H|have a serious medical problem, get medical help right away.||
9316|039|B|||
9316|040|S|SIDE EFFECTS:  Nausea, bloating, gas, heartburn, or diarrhea may||
9316|041|S|occur. If any of these effects last or get worse, tell your||
9316|042|S|doctor or pharmacist promptly.||
9316|043|S|   Tell your doctor right away if you have any serious side||
9316|044|S|effects, including: severe stomach pain, failure to have a bowel||
9316|045|S|movement after taking this product.||
9316|046|S|   A very serious allergic reaction to this product is rare.||
9316|047|S|However, get medical help right away if you notice any symptoms||
9316|048|S|of a serious allergic reaction, including: rash, itching/swelling||
9316|049|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9316|050|S|breathing.||
9316|051|S|   This is not a complete list of possible side effects. If you||
9316|052|S|notice other effects not listed above, contact your doctor or||
9316|053|S|pharmacist.||
9316|054|S|   In the US -||
9316|055|S|   Call your doctor for medical advice about side effects. You||
9316|056|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9316|057|S|www.fda.gov/medwatch.||
9316|058|S|   In Canada - Call your doctor for medical advice about side||
9316|059|S|effects. You may report side effects to Health Canada at||
9316|060|S|1-866-234-2345.||
9316|061|B|||
9316|062|P|PRECAUTIONS:  Before taking this product, tell your doctor or||
9316|063|P|pharmacist if you are allergic to it; or if you have any other||
9316|064|P|allergies. This product may contain inactive ingredients, which||
9316|065|P|can cause allergic reactions or other problems. Talk to your||
9316|066|P|pharmacist for more details.||
9316|067|P|   If you have any of the following health problems, consult your||
9316|068|P|doctor before using this product: trouble swallowing (for||
9316|069|P|example, due to esophageal stricture), stomach/intestinal||
9316|070|P|problems (including blockage, diarrhea, irritable bowel syndrome,||
9316|071|P|diverticulitis, inflammatory bowel disease such as Crohn's||
9316|072|P|disease or ulcerative colitis), certain types of cancers (breast,||
9316|073|P|ovary, uterus), problems of the uterus (such as endometriosis,||
9316|074|P|fibroids), bleeding problems, high blood fat levels||
9316|075|P|(triglycerides).||
9316|076|P|   Liquid forms of this product may contain sugar and/or alcohol.||
9316|077|P|Caution is advised if you have diabetes, alcohol dependence, or||
9316|078|P|liver disease. Ask your doctor or pharmacist about using this||
9316|079|P|product safely.||
9316|080|P|   Flaxseed has been used at normal doses in pregnancy. High||
9316|081|P|doses are not recommended for use during pregnancy. Consult your||
9316|082|P|doctor before using this product.||
9316|083|P|   It is unknown if this product passes into breast milk. Consult||
9316|084|P|your doctor before breastfeeding.||
9316|085|B|||
9316|086|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9316|087|I|medications work or increase your risk for serious side effects.||
9316|088|I|This document does not contain all possible drug interactions.||
9316|089|I|Keep a list of all the products you use (including||
9316|090|I|prescription/nonprescription drugs and herbal products) and share||
9316|091|I|it with your doctor and pharmacist. Do not start, stop, or change||
9316|092|I|the dosage of any medicines without your doctor's approval.||
9316|093|I|   Some drugs that may interact with this product include: drugs||
9316|094|I|for diabetes (including metformin, sulfonylureas such as||
9316|095|I|glipizide, glitazones such as pioglitazone), medications/other||
9316|096|I|herbal products that may increase your risk of bleeding||
9316|097|I|(including "blood thinners" such as warfarin and heparin,||
9316|098|I|anti-platelet drugs such as clopidogrel, herbs such as||
9316|099|I|danshen/garlic/ginger/ginkgo).||
9316|100|B|||
9316|101|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9316|102|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9316|103|O|poison control center right away. US residents can call||
9316|104|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9316|105|B|||
9316|106|N|NOTES:  Eating properly, drinking more fluids, and regular||
9316|107|N|exercising regularly may help prevent constipation. Consult your||
9316|108|N|doctor or pharmacist.||
9316|109|N|   Keep all medical and lab test appointments.||
9316|110|B|||
9316|111|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9316|112|D|If it is near the time of the next dose, skip the missed dose.||
9316|113|D|Use your next dose at the regular time. Do not double the dose to||
9316|114|D|catch up.||
9316|115|B|||
9316|116|R|STORAGE:  Refer to storage information printed on the package. If||
9316|117|R|you have any questions about storage, ask your pharmacist. Keep||
9316|118|R|all medications and herbal products away from children and pets.||
9316|119|R|   Do not flush medications down the toilet or pour them into a||
9316|120|R|drain unless instructed to do so. Properly discard this product||
9316|121|R|when it is expired or no longer needed. Consult your pharmacist||
9316|122|R|or local waste disposal company.||
9316|123|B|||
9316|124|A|Information last revised April 2025.||
9316|125|A|Copyright(c) 2025 First Databank, Inc.||
9316|126|B|||
9319|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9319|002|Z|does NOT have all possible information about this product. This||
9319|003|Z|information does not assure that this product is safe, effective,||
9319|004|Z|or appropriate for you. This information is not individual||
9319|005|Z|medical advice and does not substitute for the advice of your||
9319|006|Z|health care professional. Always ask your health care||
9319|007|Z|professional for complete information about this product and your||
9319|008|Z|specific health needs.||
9319|009|B|||
9319|010|T|TEGASEROD - ORAL||
9319|011|F|(TEG-a-SER-od)||
9319|012|B|||
9319|013|C|COMMON BRAND NAME(S): Zelnorm||
9319|014|B|||
9319|015|U|USES:  This medication is used by women to treat a certain||
9319|016|U|stomach/intestinal disorder (irritable bowel syndrome with||
9319|017|U|constipation, or IBS-C). Tegaserod works by speeding up the||
9319|018|U|motion in your gut. This effect shortens the time stool remains||
9319|019|U|in the bowel, and helps lessen symptoms such as belly pain and||
9319|020|U|constipation.||
9319|021|U|   This medication has not been shown to work in men with IBS.||
9319|022|B|||
9319|023|H|HOW TO USE:  Read the Medication Guide provided by your||
9319|024|H|pharmacist before you start taking tegaserod and each time you||
9319|025|H|get a refill. If you have any questions, ask your doctor or||
9319|026|H|pharmacist.||
9319|027|H|   Take this medication by mouth as directed by your doctor,||
9319|028|H|usually twice daily, at least 30 minutes before a meal. The||
9319|029|H|dosage is based on your medical condition and response to||
9319|030|H|treatment.||
9319|031|H|   Use this medication regularly to get the most benefit from it.||
9319|032|H|To help you remember, take it at the same times each day.||
9319|033|H|   Tell your doctor if your condition does not get better or if||
9319|034|H|it gets worse.||
9319|035|B|||
9319|036|S|SIDE EFFECTS:  Headache, stomach/abdominal pain, nausea, gas, or||
9319|037|S|dizziness may occur. If any of these effects last or get worse,||
9319|038|S|tell your doctor or pharmacist promptly.||
9319|039|S|   Remember that this medication has been prescribed because your||
9319|040|S|doctor has judged that the benefit to you is greater than the||
9319|041|S|risk of side effects. Many people using this medication do not||
9319|042|S|have serious side effects.||
9319|043|S|   Diarrhea commonly occurs during the first week of treatment,||
9319|044|S|but usually gets better as your body adjusts to this medication.||
9319|045|S|Diarrhea that doesn't stop may result in dehydration. Contact||
9319|046|S|your doctor promptly if you notice any symptoms of dehydration,||
9319|047|S|such as unusual decreased urination, unusual dry mouth/thirst,||
9319|048|S|fast heartbeat, or dizziness/lightheadedness.||
9319|049|S|   This medication may rarely cause damage to the intestines due||
9319|050|S|to decreased blood flow to the intestines (ischemic colitis).||
9319|051|S|Stop taking this medication and tell your doctor right away if||
9319|052|S|you develop symptoms such as bleeding from your rectum, blood in||
9319|053|S|your stools, or new/worsening abdominal pain.||
9319|054|S|   This medication may increase the risk of suicidal thoughts and||
9319|055|S|behavior. Tell your doctor right away if you or your||
9319|056|S|family/caregiver notice any unusual/sudden changes in your mood,||
9319|057|S|thoughts, or behavior such as signs of depression, suicidal||
9319|058|S|thoughts/attempts, or thoughts about harming yourself.||
9319|059|S|   Get medical help right away if you have any very serious side||
9319|060|S|effects, including: chest/jaw/left arm pain, shortness of breath,||
9319|061|S|unusual sweating, weakness on one side of the body, trouble||
9319|062|S|speaking, sudden vision changes, confusion.||
9319|063|S|   A very serious allergic reaction to this drug is rare.||
9319|064|S|However, get medical help right away if you notice any symptoms||
9319|065|S|of a serious allergic reaction, including: rash, itching/swelling||
9319|066|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9319|067|S|breathing.||
9319|068|S|   This is not a complete list of possible side effects. If you||
9319|069|S|notice other effects not listed above, contact your doctor or||
9319|070|S|pharmacist.||
9319|071|S|   In the US -||
9319|072|S|   Call your doctor for medical advice about side effects. You||
9319|073|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9319|074|S|www.fda.gov/medwatch.||
9319|075|S|   In Canada - Call your doctor for medical advice about side||
9319|076|S|effects. You may report side effects to Health Canada at||
9319|077|S|1-866-234-2345.||
9319|078|B|||
9319|079|P|PRECAUTIONS:  Before taking tegaserod, tell your doctor or||
9319|080|P|pharmacist if you are allergic to it; or if you have any other||
9319|081|P|allergies. This product may contain inactive ingredients, which||
9319|082|P|can cause allergic reactions or other problems. Talk to your||
9319|083|P|pharmacist for more details.||
9319|084|P|   Before using this medication, tell your doctor or pharmacist||
9319|085|P|your medical history, especially of: heart problems (such as||
9319|086|P|previous heart attack, angina), increased risk for heart disease||
9319|087|P|(such as high cholesterol, high blood pressure, smoking,||
9319|088|P|diabetes), kidney disease, liver problems, stroke, mental/mood||
9319|089|P|problems (such as anxiety, depression, thoughts of suicide),||
9319|090|P|other stomach/abdominal problems (such as blockage, gallbladder||
9319|091|P|problems, ischemic colitis).||
9319|092|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9319|093|P|can make you more dizzy. Do not drive, use machinery, or do||
9319|094|P|anything that needs alertness until you can do it safely. Limit||
9319|095|P|alcoholic beverages. Talk to your doctor if you are using||
9319|096|P|marijuana (cannabis).||
9319|097|P|   Before having surgery, tell your doctor or dentist about all||
9319|098|P|the products you use (including prescription drugs,||
9319|099|P|nonprescription drugs, and herbal products).||
9319|100|P|   During pregnancy, this medication should be used only when||
9319|101|P|clearly needed. Discuss the risks and benefits with your doctor.||
9319|102|P|   It is unknown if this drug passes into breast milk.||
9319|103|P|Breastfeeding is not recommended while using this drug. Consult||
9319|104|P|your doctor before breastfeeding.||
9319|105|B|||
9319|106|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9319|107|I|medications work or increase your risk for serious side effects.||
9319|108|I|This document does not contain all possible drug interactions.||
9319|109|I|Keep a list of all the products you use (including||
9319|110|I|prescription/nonprescription drugs and herbal products) and share||
9319|111|I|it with your doctor and pharmacist. Do not start, stop, or change||
9319|112|I|the dosage of any medicines without your doctor's approval.||
9319|113|B|||
9319|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9319|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9319|116|O|poison control center right away. US residents can call||
9319|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9319|118|B|||
9319|119|N|NOTES:  Do not share this medication with others.||
9319|120|B|||
9319|121|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9319|122|D|remember. If it is near the time of the next dose, skip the||
9319|123|D|missed dose. Take your next dose at the regular time. Do not||
9319|124|D|double the dose to catch up.||
9319|125|B|||
9319|126|R|STORAGE:  Store at room temperature away from light and moisture.||
9319|127|R|Do not store in the bathroom. Keep all medications away from||
9319|128|R|children and pets.||
9319|129|R|   Do not flush medications down the toilet or pour them into a||
9319|130|R|drain unless instructed to do so. Properly discard this product||
9319|131|R|when it is expired or no longer needed. Consult your pharmacist||
9319|132|R|or local waste disposal company.||
9319|133|B|||
9319|134|A|Information last revised May 2024.||
9319|135|A|Copyright(c) 2025 First Databank, Inc.||
9319|136|B|||
9323|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9323|002|Z|does NOT have all possible information about this product. This||
9323|003|Z|information does not assure that this product is safe, effective,||
9323|004|Z|or appropriate for you. This information is not individual||
9323|005|Z|medical advice and does not substitute for the advice of your||
9323|006|Z|health care professional. Always ask your health care||
9323|007|Z|professional for complete information about this product and your||
9323|008|Z|specific health needs.||
9323|009|B|||
9323|010|T|DEXTROAMPHETAMINE/AMPHETAMINE EXTENDED-RELEASE - ORAL||
9323|011|F|(DEX-troe-am-FET-a-meen/am-FET-a-meen)||
9323|012|B|||
9323|013|C|COMMON BRAND NAME(S): Adderall XR||
9323|014|B|||
9323|015|W|WARNING:  Misuse or abuse of amphetamines may cause serious||
9323|016|W|(possibly fatal) heart and blood pressure problems.||
9323|017|W|Amphetamine-type medications can be habit-forming. Use only as||
9323|018|W|directed. If you use this drug for a long time, you may become||
9323|019|W|dependent on it and may have withdrawal symptoms after stopping||
9323|020|W|the drug. Consult your doctor or pharmacist for more details.||
9323|021|W|(See also How to Use section).||
9323|022|B|||
9323|023|U|USES:  This combination medication is used to treat attention||
9323|024|U|deficit hyperactivity disorder - ADHD. It works by changing the||
9323|025|U|amounts of certain natural substances in the brain.||
9323|026|U|Amphetamine/dextroamphetamine belongs to a class of drugs known||
9323|027|U|as stimulants. It can help increase your ability to pay||
9323|028|U|attention, stay focused on an activity, and control behavior||
9323|029|U|problems. It may also help you to organize your tasks and improve||
9323|030|U|listening skills.||
9323|031|B|||
9323|032|V|OTHER USES:  This section contains uses of this drug that are not||
9323|033|V|listed in the approved professional labeling for the drug but||
9323|034|V|that may be prescribed by your health care professional. Use this||
9323|035|V|drug for a condition that is listed in this section only if it||
9323|036|V|has been so prescribed by your health care professional.||
9323|037|V|   This drug may also be used for a certain sleeping disorder||
9323|038|V|(narcolepsy). It should not be used to treat tiredness or to hold||
9323|039|V|off sleep in people who do not have a sleep disorder.||
9323|040|B|||
9323|041|H|HOW TO USE:  Read the Medication Guide and, if available, the||
9323|042|H|Patient Information Leaflet provided by your pharmacist before||
9323|043|H|you start taking amphetamine/dextroamphetamine and each time you||
9323|044|H|get a refill. If you have any questions, ask your doctor or||
9323|045|H|pharmacist.||
9323|046|H|   Take this medication by mouth with or without food as directed||
9323|047|H|by your doctor, usually once daily in the morning. You may take||
9323|048|H|this medication with or without food, but it is important to||
9323|049|H|choose one way and take this medication the same way with every||
9323|050|H|dose. Taking this medication after noon may cause trouble||
9323|051|H|sleeping (insomnia).||
9323|052|H|   Swallow the capsules whole. Do not crush or chew the capsules.||
9323|053|H|Doing so can release all of the drug at once, increasing the risk||
9323|054|H|of side effects. If you have difficulty swallowing this||
9323|055|H|medication whole, you may sprinkle the entire contents of a||
9323|056|H|capsule on a small amount of applesauce just before taking.||
9323|057|H|Swallow the mixture right away. Do not chew the mixture, and do||
9323|058|H|not save it for future use. Drink a glass of liquid after each||
9323|059|H|dose.||
9323|060|H|   The dosage is based on your medical condition and response to||
9323|061|H|treatment. Your doctor may adjust your dose to find the dose that||
9323|062|H|is best for you. Follow your doctor's instructions carefully.||
9323|063|H|   Use this medication regularly to get the most benefit from it.||
9323|064|H|To help you remember, take it at the same time each day.||
9323|065|H|   During treatment, your doctor may occasionally recommend||
9323|066|H|stopping the medication for a short time to see whether there are||
9323|067|H|any changes in your behavior and whether the medication is still||
9323|068|H|needed.||
9323|069|H|   If you suddenly stop using this medication, you may have||
9323|070|H|withdrawal symptoms (such as severe tiredness, sleep problems,||
9323|071|H|mental/mood changes such as depression). To help prevent||
9323|072|H|withdrawal, your doctor may lower your dose slowly. Withdrawal is||
9323|073|H|more likely if you have used this medication for a long time or||
9323|074|H|in high doses. Tell your doctor or pharmacist right away if you||
9323|075|H|have withdrawal.||
9323|076|H|   When this medication is used for a long time, it may not work||
9323|077|H|as well. Talk with your doctor if this medication stops working||
9323|078|H|well.||
9323|079|H|   Though it helps many people, this medication may sometimes||
9323|080|H|cause addiction. This risk may be higher if you have a substance||
9323|081|H|use disorder (such as overuse of or addiction to drugs/alcohol).||
9323|082|H|Do not increase your dose, take it more often, or use it for a||
9323|083|H|longer time than prescribed. Properly stop the medication when so||
9323|084|H|directed.||
9323|085|H|   Tell your doctor if your condition does not get better or if||
9323|086|H|it gets worse.||
9323|087|B|||
9323|088|S|SIDE EFFECTS:  Loss of appetite, weight loss, dry mouth, stomach||
9323|089|S|upset/pain, nausea/vomiting, dizziness, headache, diarrhea,||
9323|090|S|fever, nervousness, and trouble sleeping may occur. If any of||
9323|091|S|these effects last or get worse, tell your doctor promptly.||
9323|092|S|   Remember that this medication has been prescribed because your||
9323|093|S|doctor has judged that the benefit to you is greater than the||
9323|094|S|risk of side effects. Many people using this medication do not||
9323|095|S|have serious side effects.||
9323|096|S|   This medication may raise your blood pressure. Check your||
9323|097|S|blood pressure regularly and tell your doctor if the results are||
9323|098|S|high.||
9323|099|S|   Tell your doctor right away if you have any serious side||
9323|100|S|effects, including: signs of blood flow problems in the fingers||
9323|101|S|or toes (such as coldness, numbness, pain, or skin color||
9323|102|S|changes), unusual wounds on the fingers or toes,||
9323|103|S|mental/mood/behavior changes (such as agitation, aggression, mood||
9323|104|S|swings, depression, abnormal thoughts, thoughts of suicide),||
9323|105|S|uncontrolled movements, continuous chewing movements/teeth||
9323|106|S|grinding, outbursts of words/sounds, change in sexual||
9323|107|S|ability/desire, frequent/prolonged erections (in males).||
9323|108|S|   Get medical help right away if you have any very serious side||
9323|109|S|effects, including: shortness of breath, chest/jaw/left arm pain,||
9323|110|S|fainting, severe headache, fast/pounding/irregular heartbeat,||
9323|111|S|seizures, weakness on one side of the body, trouble speaking,||
9323|112|S|confusion, swelling ankles/feet, extreme tiredness, blurred||
9323|113|S|vision.||
9323|114|S|   This medication may increase serotonin and rarely cause a very||
9323|115|S|serious condition called serotonin syndrome/toxicity. The risk||
9323|116|S|increases if you are also taking other drugs that increase||
9323|117|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
9323|118|S|take (see Drug Interactions section). Get medical help right away||
9323|119|S|if you develop some of the following symptoms: fast heartbeat,||
9323|120|S|hallucinations, loss of coordination, severe dizziness, severe||
9323|121|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
9323|122|S|unusual agitation/restlessness.||
9323|123|S|   A very serious allergic reaction to this drug is rare.||
9323|124|S|However, get medical help right away if you notice any symptoms||
9323|125|S|of a serious allergic reaction, including: rash, itching/swelling||
9323|126|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9323|127|S|breathing.||
9323|128|S|   This is not a complete list of possible side effects. If you||
9323|129|S|notice other effects not listed above, contact your doctor or||
9323|130|S|pharmacist.||
9323|131|S|   In the US -||
9323|132|S|   Call your doctor for medical advice about side effects. You||
9323|133|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9323|134|S|www.fda.gov/medwatch.||
9323|135|S|   In Canada - Call your doctor for medical advice about side||
9323|136|S|effects. You may report side effects to Health Canada at||
9323|137|S|1-866-234-2345.||
9323|138|B|||
9323|139|P|PRECAUTIONS:  Before taking this medication, tell your doctor or||
9323|140|P|pharmacist if you are allergic to it; or to other sympathomimetic||
9323|141|P|drugs (such as lisdexamfetamine); or if you have any other||
9323|142|P|allergies. This product may contain inactive ingredients, which||
9323|143|P|can cause allergic reactions or other problems. Talk to your||
9323|144|P|pharmacist for more details.||
9323|145|P|   Before using this medication, tell your doctor or pharmacist||
9323|146|P|your medical history, especially of: blood circulation problems||
9323|147|P|(such as Raynaud's disease), certain mental/mood conditions (such||
9323|148|P|as agitation, psychosis), personal/family history of mental/mood||
9323|149|P|disorders (such as bipolar disorder, depression, psychotic||
9323|150|P|disorder, suicidal thoughts), heart problems (including irregular||
9323|151|P|heartbeat/rhythm, coronary artery disease, heart failure,||
9323|152|P|cardiomyopathy, problems with the heart structure such as valve||
9323|153|P|problems), family history of heart problems (such as sudden||
9323|154|P|death/irregular heartbeat/rhythm), history of stroke, high blood||
9323|155|P|pressure, overactive thyroid (hyperthyroidism), a certain eye||
9323|156|P|problem (glaucoma), seizures, personal or family history of a||
9323|157|P|substance use disorder (such as overuse of or addiction to||
9323|158|P|drugs/alcohol), personal or family history of uncontrolled muscle||
9323|159|P|movements (such as Tourette's syndrome), kidney disease, liver||
9323|160|P|disease.||
9323|161|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9323|162|P|can make you more dizzy. Do not drive, use machinery, or do||
9323|163|P|anything that needs alertness until you can do it safely. Limit||
9323|164|P|alcoholic beverages. Talk to your doctor if you are using||
9323|165|P|marijuana (cannabis).||
9323|166|P|   Before having surgery, tell your doctor or dentist about all||
9323|167|P|the products you use (including prescription drugs,||
9323|168|P|nonprescription drugs, and herbal products).||
9323|169|P|   Children (especially those younger than 6) may be more||
9323|170|P|sensitive to the side effects of this drug, especially weight||
9323|171|P|loss. This medication may slow down a child's growth. The doctor||
9323|172|P|may recommend temporarily stopping the medication from time to||
9323|173|P|time to reduce this risk. Monitor your child's weight and height.||
9323|174|P|Consult your doctor or pharmacist for more details.||
9323|175|P|   Older adults may be more sensitive to the side effects of this||
9323|176|P|drug, especially chest pain, trouble sleeping, or weight loss.||
9323|177|P|   During pregnancy, this medication should be used only when||
9323|178|P|clearly needed. Discuss the risks and benefits with your doctor.||
9323|179|P|Infants born to mothers who are dependent on this medication may||
9323|180|P|be born too soon (premature) and have low birth weight. They may||
9323|181|P|also have withdrawal symptoms. Tell your doctor right away if you||
9323|182|P|notice possible mood changes, agitation, or unusual tiredness in||
9323|183|P|your newborn.||
9323|184|P|   This medication passes into breast milk and may have||
9323|185|P|undesirable effects on a nursing infant. Breastfeeding is not||
9323|186|P|recommended while using this medication. Consult your doctor||
9323|187|P|before breastfeeding.||
9323|188|B|||
9323|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9323|190|I|medications work or increase your risk for serious side effects.||
9323|191|I|This document does not contain all possible drug interactions.||
9323|192|I|Keep a list of all the products you use (including||
9323|193|I|prescription/nonprescription drugs and herbal products) and share||
9323|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
9323|195|I|the dosage of any medicines without your doctor's approval.||
9323|196|I|   Taking MAO inhibitors with this medication may cause a serious||
9323|197|I|(possibly fatal) drug interaction. Avoid taking MAO inhibitors||
9323|198|I|(isocarboxazid, linezolid, metaxalone, methylene blue,||
9323|199|I|moclobemide, phenelzine, procarbazine, rasagiline, safinamide,||
9323|200|I|selegiline, tranylcypromine) during treatment with this||
9323|201|I|medication. Most MAO inhibitors should also not be taken for two||
9323|202|I|weeks before treatment with this medication. Ask your doctor when||
9323|203|I|to start or stop taking this medication.||
9323|204|I|   Some products have ingredients that could raise your heart||
9323|205|I|rate or blood pressure. Tell your pharmacist what products you||
9323|206|I|are using, and ask how to use them safely (especially||
9323|207|I|cough-and-cold products or diet aids).||
9323|208|I|   The risk of serotonin syndrome/toxicity increases if you are||
9323|209|I|also taking other drugs that increase serotonin. Examples include||
9323|210|I|street drugs such as MDMA/ "ecstasy," St. John's wort, certain||
9323|211|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
9323|212|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
9323|213|I|serotonin syndrome/toxicity may be more likely when you start or||
9323|214|I|increase the dose of these drugs.||
9323|215|I|   Dextroamphetamine is very similar to lisdexamfetamine. Do not||
9323|216|I|use medications containing lisdexamfetamine while using||
9323|217|I|dextroamphetamine.||
9323|218|I|   This medication may interfere with certain medical/lab tests||
9323|219|I|(such as blood and urine steroid levels, brain scan for||
9323|220|I|Parkinson's disease), possibly causing false test results. Make||
9323|221|I|sure lab personnel and all your doctors know you use this drug.||
9323|222|B|||
9323|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9323|224|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9323|225|O|poison control center right away. US residents can call||
9323|226|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9323|227|O|Symptoms of overdose may include: headache that is severe or||
9323|228|O|doesn't go away, severe mental/mood changes, seizures, severe||
9323|229|O|restlessness, fast breathing.||
9323|230|B|||
9323|231|N|NOTES:  Do not change brands or dosage forms of this medication||
9323|232|N|without consulting your doctor or pharmacist. Not all forms of||
9323|233|N|this medication work the same way.||
9323|234|N|   Do not share this medication with others. Sharing it is||
9323|235|N|against the law.||
9323|236|N|   Lab and/or medical tests (such as blood pressure, heart rate,||
9323|237|N|growth monitoring in children) may be done while you are taking||
9323|238|N|this medication. Keep all medical and lab appointments. Consult||
9323|239|N|your doctor for more details.||
9323|240|B|||
9323|241|D|MISSED DOSE:  If you miss a dose, take it as soon as you remember||
9323|242|D|in the morning hours. If it is after noon or near the time of the||
9323|243|D|next dose, skip the missed dose. Take your next dose at the||
9323|244|D|regular time. Do not double the dose to catch up.||
9323|245|B|||
9323|246|R|STORAGE:  Store at room temperature away from light and moisture.||
9323|247|R|Do not store in the bathroom. Keep all medications away from||
9323|248|R|children and pets.||
9323|249|R|   Do not flush medications down the toilet or pour them into a||
9323|250|R|drain unless instructed to do so. Properly discard this product||
9323|251|R|when it is expired or no longer needed. Consult your pharmacist||
9323|252|R|or local waste disposal company.||
9323|253|B|||
9323|254|A|Information last revised July 2025.||
9323|255|A|Copyright(c) 2025 First Databank, Inc.||
9323|256|B|||
9324|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9324|002|Z|does NOT have all possible information about this product. This||
9324|003|Z|information does not assure that this product is safe, effective,||
9324|004|Z|or appropriate for you. This information is not individual||
9324|005|Z|medical advice and does not substitute for the advice of your||
9324|006|Z|health care professional. Always ask your health care||
9324|007|Z|professional for complete information about this product and your||
9324|008|Z|specific health needs.||
9324|009|B|||
9324|010|T|AZELASTINE DROPS - OPHTHALMIC||
9324|011|F|(AY-ze-LAS-teen)||
9324|012|B|||
9324|013|C|COMMON BRAND NAME(S): Optivar||
9324|014|B|||
9324|015|U|USES:  This medication is used to treat itching eyes caused by||
9324|016|U|allergies (allergic conjunctivitis). Azelastine belongs to a||
9324|017|U|class of drugs known as antihistamines. It works by blocking||
9324|018|U|certain natural substances called histamines that are responsible||
9324|019|U|for allergic symptoms.||
9324|020|U|   Do not use this medication to treat redness and irritation due||
9324|021|U|to wearing contact lenses.||
9324|022|B|||
9324|023|H|HOW TO USE:  Use this medication in the affected eye(s) as||
9324|024|H|directed by your doctor, usually twice daily.||
9324|025|H|   To apply eye drops, wash hands first. To avoid contamination,||
9324|026|H|do not touch the dropper tip or let it touch your eye or any||
9324|027|H|other surface.||
9324|028|H|   If you are wearing contact lenses, remove them before using||
9324|029|H|eye drops. Wait at least 10 minutes before replacing your contact||
9324|030|H|lenses. Tilt your head back, look upward, and pull down the lower||
9324|031|H|eyelid to make a pouch. Hold the dropper directly over your eye||
9324|032|H|and place one drop into the pouch. Look downward, gently close||
9324|033|H|your eyes, and place one finger at the corner of your eye (near||
9324|034|H|the nose). Apply gentle pressure for 1 to 2 minutes before||
9324|035|H|opening your eyes. This will prevent the medication from draining||
9324|036|H|out. Try not to blink or rub your eye. Repeat these steps if your||
9324|037|H|dose is for more than one drop. If directed to use this||
9324|038|H|medication in both eyes, repeat these steps for your other eye.||
9324|039|H|Do not rinse the dropper. Replace the dropper cap after each use.||
9324|040|H|   If you are using another kind of eye medication (such as drops||
9324|041|H|or ointments), wait at least 5 minutes before applying other||
9324|042|H|medications. Use eye drops before eye ointments to allow the||
9324|043|H|drops to enter the eye.||
9324|044|H|   Wait several minutes for your vision to clear before driving||
9324|045|H|or operating machinery.||
9324|046|H|   Use this medication regularly to get the most benefit from it.||
9324|047|H|To help you remember, use it at the same times each day.||
9324|048|H|   Do not increase your dose or use this drug more often or for||
9324|049|H|longer than prescribed. Your condition will not improve any||
9324|050|H|faster, and your risk of side effects will increase.||
9324|051|H|   Tell your doctor if you do not get better or if you get worse.||
9324|052|B|||
9324|053|S|SIDE EFFECTS:  This medication may temporarily sting or burn your||
9324|054|S|eyes for a minute or two after use. Temporary blurred vision,||
9324|055|S|headache, or a bitter taste in your mouth may also occur. If any||
9324|056|S|of these effects last or get worse, tell your doctor or||
9324|057|S|pharmacist promptly.||
9324|058|S|   Remember that this medication has been prescribed because your||
9324|059|S|doctor has judged that the benefit to you is greater than the||
9324|060|S|risk of side effects. Many people using this medication do not||
9324|061|S|have serious side effects.||
9324|062|S|   Tell your doctor right away if you have any serious side||
9324|063|S|effects, including: eye pain.||
9324|064|S|   A very serious allergic reaction to this drug is rare.||
9324|065|S|However, get medical help right away if you notice any symptoms||
9324|066|S|of a serious allergic reaction, including: rash, itching/swelling||
9324|067|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9324|068|S|breathing.||
9324|069|S|   This is not a complete list of possible side effects. If you||
9324|070|S|notice other effects not listed above, contact your doctor or||
9324|071|S|pharmacist.||
9324|072|S|   In the US -||
9324|073|S|   Call your doctor for medical advice about side effects. You||
9324|074|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9324|075|S|www.fda.gov/medwatch.||
9324|076|S|   In Canada - Call your doctor for medical advice about side||
9324|077|S|effects. You may report side effects to Health Canada at||
9324|078|S|1-866-234-2345.||
9324|079|B|||
9324|080|P|PRECAUTIONS:  Before using azelastine, tell your doctor or||
9324|081|P|pharmacist if you are allergic to it; or if you have any other||
9324|082|P|allergies. This product may contain inactive ingredients, which||
9324|083|P|can cause allergic reactions or other problems. Talk to your||
9324|084|P|pharmacist for more details.||
9324|085|P|   Before using this medication, tell your doctor or pharmacist||
9324|086|P|your medical history.||
9324|087|P|   After you apply this drug, your vision may become temporarily||
9324|088|P|blurred. Do not drive, use machinery, or do anything that needs||
9324|089|P|clear vision until you can do it safely.||
9324|090|P|   Before having surgery, tell your doctor or dentist about all||
9324|091|P|the products you use (including prescription drugs,||
9324|092|P|nonprescription drugs, and herbal products).||
9324|093|P|   During pregnancy, this medication should be used only when||
9324|094|P|clearly needed. Discuss the risks and benefits with your doctor.||
9324|095|P|   It is unknown if this drug passes into breast milk. Consult||
9324|096|P|your doctor before breastfeeding.||
9324|097|B|||
9324|098|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9324|099|I|medications work or increase your risk for serious side effects.||
9324|100|I|This document does not contain all possible drug interactions.||
9324|101|I|Keep a list of all the products you use (including||
9324|102|I|prescription/nonprescription drugs and herbal products) and share||
9324|103|I|it with your doctor and pharmacist. Do not start, stop, or change||
9324|104|I|the dosage of any medicines without your doctor's approval.||
9324|105|B|||
9324|106|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9324|107|O|has overdosed and has serious symptoms such as passing out or||
9324|108|O|trouble breathing, call 911. Otherwise, call a poison control||
9324|109|O|center right away. US residents can call 1-800-222-1222. Canada||
9324|110|O|residents can call 1-844-764-7669.||
9324|111|B|||
9324|112|N|NOTES:  Do not share this medication with others.||
9324|113|N|   Ask your doctor for ways to reduce your exposure to substances||
9324|114|N|(such as pollen, pet dander, dust mites, mold, smoke) that can||
9324|115|N|worsen allergy symptoms.||
9324|116|B|||
9324|117|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9324|118|D|If it is near the time of the next dose, skip the missed dose.||
9324|119|D|Use your next dose at the regular time. Do not double the dose to||
9324|120|D|catch up.||
9324|121|B|||
9324|122|R|STORAGE:  Different brands of this medication have different||
9324|123|R|storage needs. Check the product package for instructions on how||
9324|124|R|to store your brand, or ask your pharmacist. Keep the bottle||
9324|125|R|upright. Keep all medications away from children and pets.||
9324|126|R|   Do not flush medications down the toilet or pour them into a||
9324|127|R|drain unless instructed to do so. Properly discard this product||
9324|128|R|when it is expired or no longer needed. Consult your pharmacist||
9324|129|R|or local waste disposal company.||
9324|130|B|||
9324|131|A|Information last revised September 2024.||
9324|132|A|Copyright(c) 2025 First Databank, Inc.||
9324|133|B|||
9327|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9327|002|Z|does NOT have all possible information about this product. This||
9327|003|Z|information does not assure that this product is safe, effective,||
9327|004|Z|or appropriate for you. This information is not individual||
9327|005|Z|medical advice and does not substitute for the advice of your||
9327|006|Z|health care professional. Always ask your health care||
9327|007|Z|professional for complete information about this product and your||
9327|008|Z|specific health needs.||
9327|009|B|||
9327|010|T|RITUXIMAB - INJECTION||
9327|011|F|(ri-TUX-i-mab)||
9327|012|B|||
9327|013|C|COMMON BRAND NAME(S): Riabni, Rituxan, Ruxience, Truxima||
9327|014|B|||
9327|015|W|WARNING:  Rituximab may rarely cause serious (sometimes fatal)||
9327|016|W|side effects including severe breathing problems or heart||
9327|017|W|problems (such as heart attack, irregular heartbeat). If these||
9327|018|W|serious side effects occur, they usually happen during the first||
9327|019|W|treatment with rituximab. Your doctor will carefully watch you||
9327|020|W|during treatment and may stop or slow down your treatment if you||
9327|021|W|have any signs of a reaction. Get medical help right away if you||
9327|022|W|have trouble breathing, itching, swelling (especially of the||
9327|023|W|throat/lips), dizziness, fast/slow/irregular heartbeat, or chest||
9327|024|W|pain.||
9327|025|W|   Rarely, people using this medication have had serious||
9327|026|W|(sometimes fatal) skin reactions (such as Stevens-Johnson||
9327|027|W|syndrome). Get medical help right away if you develop any rash,||
9327|028|W|blisters, peeling skin, or sores on your skin, lips, or in your||
9327|029|W|mouth.||
9327|030|W|   This medication may increase your risk of getting a rare but||
9327|031|W|very serious (possibly fatal) brain infection (progressive||
9327|032|W|multifocal leukoencephalopathy-PML). Get medical help right away||
9327|033|W|if you have any of these side effects: clumsiness, loss of||
9327|034|W|coordination/balance, weakness, sudden change in your thinking||
9327|035|W|(such as confusion, difficulty concentrating, memory loss),||
9327|036|W|difficulty talking/walking, seizure, vision changes.||
9327|037|W|   Rituximab may cause serious (possibly fatal) liver disease in||
9327|038|W|people who have a current or past infection with hepatitis B.||
9327|039|W|This may occur during treatment or up to 2 years after treatment||
9327|040|W|is finished. Before starting this medication, tell your doctor if||
9327|041|W|you have ever had hepatitis B. Your doctor should order a test to||
9327|042|W|see if you have the hepatitis B infection before starting||
9327|043|W|treatment. Tell your doctor right away if you have symptoms of||
9327|044|W|liver disease, such as nausea/vomiting that doesn't stop, loss of||
9327|045|W|appetite, stomach/abdominal pain, yellowing eyes/skin, or dark||
9327|046|W|urine.||
9327|047|B|||
9327|048|U|USES:  Rituximab is used to treat certain types of cancer (such||
9327|049|U|as non-Hodgkin's lymphoma, chronic lymphocytic leukemia). It||
9327|050|U|works by slowing or stopping the growth of cancer cells.||
9327|051|U|   Some brands of rituximab are also used to treat rheumatoid||
9327|052|U|arthritis and can decrease joint pain and swelling. This drug is||
9327|053|U|also used to treat certain types of blood vessel disease (such as||
9327|054|U|granulomatosis with polyangiitis, microscopic polyangiitis) and||
9327|055|U|can decrease the swelling of the blood vessels. Rituximab is also||
9327|056|U|used to treat a certain skin condition (pemphigus vulgaris). It||
9327|057|U|helps to reduce the number of skin lesions.||
9327|058|U|   This monograph is about the following rituximab products:||
9327|059|U|rituximab, rituximab-abbs, rituximab-arrx, and rituximab-pvvr.||
9327|060|B|||
9327|061|H|HOW TO USE:  Read the Medication Guide provided by your||
9327|062|H|pharmacist before you start using rituximab and each time you get||
9327|063|H|a refill. If you have any questions, ask your doctor or||
9327|064|H|pharmacist.||
9327|065|H|   Your doctor should prescribe other medications (such as||
9327|066|H|acetaminophen, an antihistamine, methylprednisolone) for you to||
9327|067|H|take before each treatment to help reduce side effects, such as||
9327|068|H|fever and chills. Carefully follow your doctor's instructions.||
9327|069|H|   This medication is given by slow injection into a vein by a||
9327|070|H|health care professional as directed by your doctor. The dosage||
9327|071|H|and treatment schedule are based on your medical condition, body||
9327|072|H|size, and response to treatment.||
9327|073|B|||
9327|074|S|SIDE EFFECTS:  See also Warning section.||
9327|075|S|   Nausea, vomiting, headache, dizziness, joint/muscle pain,||
9327|076|S|weakness, or flushing may occur. If any of these effects last or||
9327|077|S|get worse, tell your doctor or pharmacist promptly.||
9327|078|S|   People using this medication may have serious side effects.||
9327|079|S|However, you have been prescribed this drug because your doctor||
9327|080|S|has judged that the benefit to you is greater than the risk of||
9327|081|S|side effects. Careful monitoring by your doctor may decrease your||
9327|082|S|risk.||
9327|083|S|   Tell your doctor right away if you have any serious side||
9327|084|S|effects, including: signs of stomach/intestinal blockage (such as||
9327|085|S|vomiting that doesn't stop, stomach/abdominal pain), swelling||
9327|086|S|hands/ankles/feet, increased thirst/urination, numbness/tingling||
9327|087|S|of arms/legs.||
9327|088|S|   Rituximab sometimes causes side effects due to the rapid||
9327|089|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
9327|090|S|risk, your doctor may add a medication and tell you to drink||
9327|091|S|plenty of fluids. Tell your doctor right away if you have||
9327|092|S|symptoms such as: low back/side pain (flank pain), signs of||
9327|093|S|kidney problems (such as painful urination, pink/bloody urine,||
9327|094|S|change in the amount of urine), muscle spasms/weakness.||
9327|095|S|   This medication can decrease blood cells, which can cause||
9327|096|S|anemia, decrease your body's ability to fight an infection, or||
9327|097|S|cause easy bruising/bleeding. Tell your doctor right away if you||
9327|098|S|develop any of the following symptoms: easy bleeding/bruising,||
9327|099|S|black/tarry stools, vomit that looks like coffee grounds, signs||
9327|100|S|of an infection (such as sore throat that doesn't go away, fever,||
9327|101|S|chills), unusual tiredness, pale skin.||
9327|102|S|   A very serious allergic reaction to this drug is rare.||
9327|103|S|However, get medical help right away if you notice any symptoms||
9327|104|S|of a serious allergic reaction, including: rash, itching/swelling||
9327|105|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9327|106|S|breathing.||
9327|107|S|   This is not a complete list of possible side effects. If you||
9327|108|S|notice other effects not listed above, contact your doctor or||
9327|109|S|pharmacist.||
9327|110|S|   In the US -||
9327|111|S|   Call your doctor for medical advice about side effects. You||
9327|112|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9327|113|S|www.fda.gov/medwatch.||
9327|114|S|   In Canada - Call your doctor for medical advice about side||
9327|115|S|effects. You may report side effects to Health Canada at||
9327|116|S|1-866-234-2345.||
9327|117|B|||
9327|118|P|PRECAUTIONS:  Before using rituximab, tell your doctor or||
9327|119|P|pharmacist if you are allergic to it; or to any rituximab||
9327|120|P|products; or if you have any other allergies. This product may||
9327|121|P|contain inactive ingredients, which can cause allergic reactions||
9327|122|P|or other problems. Talk to your pharmacist for more details.||
9327|123|P|   Before using this medication, tell your doctor or pharmacist||
9327|124|P|your medical history, especially of: lung disease, heart problems||
9327|125|P|(such as irregular heartbeat, previous heart attack),||
9327|126|P|bleeding/blood disorders, current/recent infections.||
9327|127|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9327|128|P|can make you more dizzy. Do not drive, use machinery, or do||
9327|129|P|anything that needs alertness until you can do it safely. Limit||
9327|130|P|alcoholic beverages. Talk to your doctor if you are using||
9327|131|P|marijuana (cannabis).||
9327|132|P|   Before having surgery, tell your doctor or dentist about all||
9327|133|P|the products you use (including prescription drugs,||
9327|134|P|nonprescription drugs, and herbal products).||
9327|135|P|   Rituximab can make you more likely to get infections or may||
9327|136|P|make current infections worse. Stay away from anyone who has an||
9327|137|P|infection that may easily spread (such as chickenpox, COVID-19,||
9327|138|P|measles, flu). Talk to your doctor if you have been exposed to an||
9327|139|P|infection or for more details.||
9327|140|P|   Tell your health care professional that you are using||
9327|141|P|rituximab before having any immunizations/vaccinations. Avoid||
9327|142|P|contact with people who have recently received live vaccines||
9327|143|P|(such as flu vaccine inhaled through the nose).||
9327|144|P|   To lower the chance of getting cut, bruised, or injured, use||
9327|145|P|caution with sharp objects like razors and nail cutters, and||
9327|146|P|avoid activities such as contact sports.||
9327|147|P|   Older adults may be at greater risk for heart problems (such||
9327|148|P|as irregular heartbeat) or lung problems while using this drug.||
9327|149|P|   Tell your doctor if you are pregnant or plan to become||
9327|150|P|pregnant. You should not become pregnant while using rituximab.||
9327|151|P|Rituximab may harm an unborn baby. Your doctor should order a||
9327|152|P|pregnancy test before you start this medication. Ask about||
9327|153|P|reliable forms of birth control while using this medication and||
9327|154|P|for 1 year after the last dose. If you become pregnant, talk to||
9327|155|P|your doctor right away about the risks and benefits of this||
9327|156|P|medication.||
9327|157|P|   This drug passes into breast milk. Because of the possible||
9327|158|P|risk to the infant, breastfeeding is not recommended while using||
9327|159|P|this drug and for at least 6 months after the last dose. Consult||
9327|160|P|your doctor before breastfeeding.||
9327|161|B|||
9327|162|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9327|163|I|medications work or increase your risk for serious side effects.||
9327|164|I|This document does not contain all possible drug interactions.||
9327|165|I|Keep a list of all the products you use (including||
9327|166|I|prescription/nonprescription drugs and herbal products) and share||
9327|167|I|it with your doctor and pharmacist. Do not start, stop, or change||
9327|168|I|the dosage of any medicines without your doctor's approval.||
9327|169|I|   Some products that may interact with this drug are: other||
9327|170|I|drugs that weaken the immune system/increase the risk of||
9327|171|I|infection (such as tofacitinib, natalizumab, fingolimod).||
9327|172|B|||
9327|173|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9327|174|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9327|175|O|poison control center right away. US residents can call||
9327|176|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9327|177|B|||
9327|178|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
9327|179|N|hepatitis B virus, kidney/liver function) should be done before||
9327|180|N|you start using this medication and while you are using it. Keep||
9327|181|N|all medical and lab appointments.||
9327|182|B|||
9327|183|D|MISSED DOSE:  It is important to get each dose of this medication||
9327|184|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9327|185|D|right away for a new dosing schedule.||
9327|186|B|||
9327|187|R|STORAGE:  Not applicable. This medication is given in a hospital||
9327|188|R|or clinic or doctor's office and will not be stored at home.||
9327|189|R|   Do not flush medications down the toilet or pour them into a||
9327|190|R|drain unless instructed to do so. Properly discard this product||
9327|191|R|when it is expired or no longer needed. Consult your pharmacist||
9327|192|R|or local waste disposal company.||
9327|193|B|||
9327|194|M|MEDICAL ALERT:  Your condition can cause complications in a||
9327|195|M|medical emergency. For information about enrolling in MedicAlert,||
9327|196|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9327|197|B|||
9327|198|A|Information last revised March 2025.||
9327|199|A|Copyright(c) 2025 First Databank, Inc.||
9327|200|B|||
9330|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9330|002|Z|does NOT have all possible information about this product. This||
9330|003|Z|information does not assure that this product is safe, effective,||
9330|004|Z|or appropriate for you. This information is not individual||
9330|005|Z|medical advice and does not substitute for the advice of your||
9330|006|Z|health care professional. Always ask your health care||
9330|007|Z|professional for complete information about this product and your||
9330|008|Z|specific health needs.||
9330|009|B|||
9330|010|T|LAMIVUDINE-HBV - ORAL||
9330|011|F|(la-MIV-ue-deen)||
9330|012|B|||
9330|013|C|COMMON BRAND NAME(S): Epivir HBV||
9330|014|B|||
9330|015|W|WARNING:  HIV counseling and testing should be offered to all||
9330|016|W|patients both before and during treatment with lamivudine-HBV.||
9330|017|W|Lamivudine-HBV contains a lower dose of the drug lamivudine,||
9330|018|W|which is used to treat HIV infection as well as hepatitis B. Use||
9330|019|W|of lamivudine-HBV in patients with unknown or untreated HIV||
9330|020|W|infection could result in new types of HIV virus that are more||
9330|021|W|difficult to treat (drug-resistant).||
9330|022|W|   Severe worsening of hepatitis has occurred when this||
9330|023|W|medication is stopped. Liver and blood testing should continue||
9330|024|W|for several months after lamivudine-HBV is stopped. Consult your||
9330|025|W|doctor or pharmacist for more information.||
9330|026|B|||
9330|027|U|USES:  Lamivudine-HBV is used to treat hepatitis B infection. It||
9330|028|U|is not a cure for hepatitis B and does not prevent the passing of||
9330|029|U|hepatitis B to others. This medication is a nucleoside reverse||
9330|030|U|transcriptase inhibitor (NRTI) that works by slowing the growth||
9330|031|U|of the virus, thereby decreasing liver damage caused by the||
9330|032|U|virus.||
9330|033|B|||
9330|034|H|HOW TO USE:  Read the Patient Information Leaflet if available||
9330|035|H|from your pharmacist before you start using lamivudine-HBV and||
9330|036|H|each time you get a refill. If you have any questions, ask your||
9330|037|H|doctor or pharmacist.||
9330|038|H|   Take lamivudine-HBV by mouth with or without food as directed||
9330|039|H|by your doctor, usually once a day. The dosage is based on your||
9330|040|H|medical condition and response to treatment.||
9330|041|H|   Use this medicine regularly in order to get the most benefit||
9330|042|H|from it. This medication works best when the amount of drug in||
9330|043|H|your body is kept at a constant level. Remember to use it at the||
9330|044|H|same time each day. Do not skip any doses.||
9330|045|H|   Do not stop taking this medication without consulting your||
9330|046|H|doctor. Worsening of your condition, decreased response to||
9330|047|H|medication, or development of drug-resistant types of the virus||
9330|048|H|may occur during or after treatment. Promptly report any new||
9330|049|H|symptoms that occur during or after treatment to your doctor.||
9330|050|B|||
9330|051|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, dizziness, headache,||
9330|052|S|tiredness, or infections of the ear/nose/throat may occur. If any||
9330|053|S|of these effects last or get worse, tell your doctor or||
9330|054|S|pharmacist promptly.||
9330|055|S|   Remember that this medication has been prescribed because your||
9330|056|S|doctor has judged that the benefit to you is greater than the||
9330|057|S|risk of side effects. Many people using this medication do not||
9330|058|S|have serious side effects.||
9330|059|S|   Rarely, lamivudine-HBV has caused severe (sometimes fatal)||
9330|060|S|liver problems and a buildup of lactic acid in the blood (lactic||
9330|061|S|acidosis). These serious side effects may occur more often in||
9330|062|S|women and obese patients. Get medical help right away if you have||
9330|063|S|any very serious side effects, including: symptoms of liver||
9330|064|S|problems (such as nausea/vomiting that doesn't stop, loss of||
9330|065|S|appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
9330|066|S|urine), symptoms of lactic acidosis (such as deep/rapid||
9330|067|S|breathing, drowsiness, nausea/vomiting).||
9330|068|S|   Tell your doctor right away if you have any serious side||
9330|069|S|effects, including: mental/mood changes, muscle/joint pain,||
9330|070|S|tingling/numbness in hands or feet.||
9330|071|S|   A very serious allergic reaction to this drug is rare.||
9330|072|S|However, get medical help right away if you notice any symptoms||
9330|073|S|of a serious allergic reaction, including: rash, itching/swelling||
9330|074|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9330|075|S|breathing.||
9330|076|S|   This is not a complete list of possible side effects. If you||
9330|077|S|notice other effects not listed above, contact your doctor or||
9330|078|S|pharmacist.||
9330|079|S|   In the US -||
9330|080|S|   Call your doctor for medical advice about side effects. You||
9330|081|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9330|082|S|www.fda.gov/medwatch.||
9330|083|S|   In Canada - Call your doctor for medical advice about side||
9330|084|S|effects. You may report side effects to Health Canada at||
9330|085|S|1-866-234-2345.||
9330|086|B|||
9330|087|P|PRECAUTIONS:  Before taking lamivudine-HBV, tell your doctor or||
9330|088|P|pharmacist if you are allergic to it; or if you have any other||
9330|089|P|allergies. This product may contain inactive ingredients, which||
9330|090|P|can cause allergic reactions or other problems. Talk to your||
9330|091|P|pharmacist for more details.||
9330|092|P|   Before using lamivudine-HBV, tell your doctor or pharmacist||
9330|093|P|your medical history, especially of: pancreatitis, HIV infection,||
9330|094|P|kidney disease, blood disorders, liver disease.||
9330|095|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9330|096|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9330|097|P|machinery, or do anything that needs alertness until you can do||
9330|098|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
9330|099|P|are using marijuana (cannabis).||
9330|100|P|   Liquid preparations of lamivudine-HBV contain sugar (sucrose).||
9330|101|P|If you are a diabetic using the liquid form of this drug, closer||
9330|102|P|monitoring of your blood sugar is recommended as you begin using||
9330|103|P|this drug. Talk with your doctor or pharmacist for more details.||
9330|104|P|   Before having surgery, tell your doctor or dentist about all||
9330|105|P|the products you use (including prescription drugs,||
9330|106|P|nonprescription drugs, and herbal products).||
9330|107|P|   Children may be more sensitive to the side effects of this||
9330|108|P|drug, especially the increased risk of pancreatitis.||
9330|109|P|   During pregnancy, this medication should be used only when||
9330|110|P|clearly needed. Discuss the risks and benefits with your doctor.||
9330|111|P|This medication has not been shown to prevent the passing of||
9330|112|P|hepatitis B from the mother to the newborn. Consult your doctor||
9330|113|P|for more information.||
9330|114|P|   This medication passes into breast milk. Consult your doctor||
9330|115|P|before breastfeeding.||
9330|116|B|||
9330|117|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9330|118|I|medications work or increase your risk for serious side effects.||
9330|119|I|This document does not contain all possible drug interactions.||
9330|120|I|Keep a list of all the products you use (including||
9330|121|I|prescription/nonprescription drugs and herbal products) and share||
9330|122|I|it with your doctor and pharmacist. Do not start, stop, or change||
9330|123|I|the dosage of any medicines without your doctor's approval.||
9330|124|I|   A product that may interact with this drug is: sorbitol.||
9330|125|I|   Do not take this medication with other products (including||
9330|126|I|those that treat HIV infection) that contain lamivudine.||
9330|127|I|   Emtricitabine is similar to lamivudine and should not be taken||
9330|128|I|with this medication.||
9330|129|I|   This medication may interfere with certain lab tests (such as||
9330|130|I|liver function tests), possibly causing false test results. Make||
9330|131|I|sure lab personnel and all your doctors know you use this drug.||
9330|132|B|||
9330|133|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9330|134|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9330|135|O|poison control center right away. US residents can call||
9330|136|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9330|137|B|||
9330|138|N|NOTES:  To avoid spreading hepatitis B to others, always use an||
9330|139|N|effective barrier method (such as latex condoms/dental dams)||
9330|140|N|during sexual activity. Consult your doctor or pharmacist for||
9330|141|N|more details.||
9330|142|N|   Do not share this medication with others.||
9330|143|N|   Lab and/or medical tests (such as liver function, complete||
9330|144|N|blood counts, hepatitis B virus DNA levels) should be done while||
9330|145|N|you are taking this medication. Keep all medical and lab||
9330|146|N|appointments. Consult your doctor for more details.||
9330|147|N|   Different brands of this drug have different amounts of active||
9330|148|N|drug. Do not switch brands of this medication without first||
9330|149|N|checking with your doctor. If you have an HIV infection, you||
9330|150|N|should be taking the higher-strength dosage. Consult your doctor||
9330|151|N|or pharmacist for more details.||
9330|152|B|||
9330|153|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9330|154|D|remember. If it is near the time of the next dose, skip the||
9330|155|D|missed dose. Take your next dose at the regular time. Do not||
9330|156|D|double the dose to catch up.||
9330|157|B|||
9330|158|R|STORAGE:  Different brands of this medication have different||
9330|159|R|storage needs. Check the product package for instructions on how||
9330|160|R|to store your brand, or ask your pharmacist. Keep all medications||
9330|161|R|away from children and pets.||
9330|162|R|   Do not flush medications down the toilet or pour them into a||
9330|163|R|drain unless instructed to do so. Properly discard this product||
9330|164|R|when it is expired or no longer needed. Consult your pharmacist||
9330|165|R|or local waste disposal company.||
9330|166|B|||
9330|167|A|Information last revised January 2025.||
9330|168|A|Copyright(c) 2025 First Databank, Inc.||
9330|169|B|||
9336|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9336|002|Z|does NOT have all possible information about this product. This||
9336|003|Z|information does not assure that this product is safe, effective,||
9336|004|Z|or appropriate for you. This information is not individual||
9336|005|Z|medical advice and does not substitute for the advice of your||
9336|006|Z|health care professional. Always ask your health care||
9336|007|Z|professional for complete information about this product and your||
9336|008|Z|specific health needs.||
9336|009|B|||
9336|010|T|HYDROCORTISONE/LIDOCAINE - TOPICAL||
9336|011|F|(HYE-droe-KOR-ti-sone/LIE-doh-cane)||
9336|012|B|||
9336|013|C|COMMON BRAND NAME(S): Lida Mantle HC||
9336|014|B|||
9336|015|U|USES:  This combination medication is used to treat irritation,||
9336|016|U|soreness, and itchiness from certain skin conditions (such as||
9336|017|U|scrapes, minor burns, eczema, insect bites). It can also be used||
9336|018|U|to treat minor discomfort and itching caused by hemorrhoids and||
9336|019|U|other problems of the anal area (such as anal fissures). This||
9336|020|U|medication contains lidocaine, an anesthetic that works to||
9336|021|U|decrease pain by temporarily numbing the area. This product also||
9336|022|U|contains hydrocortisone, a corticosteroid that reduces redness,||
9336|023|U|itching, and swelling.||
9336|024|B|||
9336|025|H|HOW TO USE:  Wash your hands before applying the medication.||
9336|026|H|Clean and dry the area to be treated.||
9336|027|H|   Apply a thin layer of medication to the affected area of skin||
9336|028|H|as directed by your doctor, usually 2 or 3 times daily. If you||
9336|029|H|are using the medicated pads, use each pad only once and discard||
9336|030|H|the pad after one use. Do not save used pads for later.||
9336|031|H|   To apply this medication to the outside of the anus, apply a||
9336|032|H|small amount to the affected area and rub in gently. Do not apply||
9336|033|H|this medication inside the anus.||
9336|034|H|   The dosage is based on your medical condition and response to||
9336|035|H|treatment. Use this medication regularly in order to get the most||
9336|036|H|benefit from it. To help you remember, use it at the same times||
9336|037|H|each day.||
9336|038|H|   Do not use on large areas of the body, apply heat or cover the||
9336|039|H|area with waterproof bandages or plastic unless directed to do so||
9336|040|H|by your doctor.||
9336|041|H|   Wash hands immediately after use unless you are treating an||
9336|042|H|area on the hands. Avoid getting the product in your eyes, nose,||
9336|043|H|ears, or mouth. If the medication gets in these areas, rinse the||
9336|044|H|area immediately with clean water.||
9336|045|H|   Do not use more of this product, use it more often, or keep||
9336|046|H|using it longer than prescribed by your doctor. If you have been||
9336|047|H|using this medication for a long time or in high doses, do not||
9336|048|H|suddenly stop using it without your doctor's approval. Some||
9336|049|H|conditions may become worse when this drug is suddenly stopped.||
9336|050|H|Your dose may need to be gradually decreased.||
9336|051|H|   Tell your doctor if your condition does not get better or if||
9336|052|H|it gets worse after 1 to 2 weeks.||
9336|053|B|||
9336|054|S|SIDE EFFECTS:  Redness, swelling, or temporary numbness at the||
9336|055|S|treated area may occur. If any of these effects last or get||
9336|056|S|worse, tell your doctor.||
9336|057|S|   Remember that this medication has been prescribed because your||
9336|058|S|doctor has judged that the benefit to you is greater than the||
9336|059|S|risk of side effects. Many people using this medication do not||
9336|060|S|have serious side effects.||
9336|061|S|   Tell your doctor right away if you have any serious side||
9336|062|S|effects, including: change in skin appearance (such as color,||
9336|063|S|stretch marks, thinning skin), skin redness/tenderness/pus, signs||
9336|064|S|of infection (such as sore throat that doesn't go away, fever,||
9336|065|S|chills).||
9336|066|S|   Get medical help right away if you have any very serious side||
9336|067|S|effects, including: slow/shallow breathing, seizures,||
9336|068|S|pale/bluish/gray skin, unusual tiredness, shortness of breath,||
9336|069|S|fast/slow/irregular heartbeat.||
9336|070|S|   A very serious allergic reaction to this drug is rare.||
9336|071|S|However, get medical help right away if you notice any symptoms||
9336|072|S|of a serious allergic reaction, including: rash, itching/swelling||
9336|073|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9336|074|S|breathing.||
9336|075|S|   This is not a complete list of possible side effects. If you||
9336|076|S|notice any other effects not listed above, contact your doctor or||
9336|077|S|pharmacist.||
9336|078|S|   In the US -||
9336|079|S|   Call your doctor for medical advice about side effects. You||
9336|080|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9336|081|S|www.fda.gov/medwatch.||
9336|082|S|   In Canada - Call your doctor for medical advice about side||
9336|083|S|effects. You may report side effects to Health Canada at||
9336|084|S|1-866-234-2345.||
9336|085|B|||
9336|086|P|PRECAUTIONS:  Before using this product, tell your doctor or||
9336|087|P|pharmacist if you are allergic to lidocaine; or to other amide||
9336|088|P|anesthetics (such as bupivacaine, prilocaine); or to||
9336|089|P|hydrocortisone; or if you have any other allergies. This product||
9336|090|P|may contain inactive ingredients, which can cause allergic||
9336|091|P|reactions or other problems. Talk to your pharmacist for more||
9336|092|P|details.||
9336|093|P|   Before using this medication, tell your doctor or pharmacist||
9336|094|P|your medical history, especially of: diabetes, eye problems,||
9336|095|P|current/recent infections (such as tuberculosis, chickenpox,||
9336|096|P|herpes), skin sores/infections (such as fungal infections), liver||
9336|097|P|disease, stomach/intestinal problems, a certain blood disorder||
9336|098|P|(methemoglobinemia).||
9336|099|P|   If there is an infection or sore in the area to be treated, do||
9336|100|P|not use this medication without consulting your doctor first.||
9336|101|P|   Children may be more sensitive to the effects of too much||
9336|102|P|corticosteroid medication. Consult your doctor for more details.||
9336|103|P|   During pregnancy, this medication should be used only when||
9336|104|P|clearly needed. It should not be used for long periods of time or||
9336|105|P|in large amounts. Discuss the risks and benefits with your||
9336|106|P|doctor.||
9336|107|P|   Lidocaine passes into breast milk. It is unknown if||
9336|108|P|hydrocortisone passes into breast milk. Consult your doctor||
9336|109|P|before breastfeeding.||
9336|110|B|||
9336|111|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9336|112|I|medications work or increase your risk for serious side effects.||
9336|113|I|This document does not contain all possible drug interactions.||
9336|114|I|Keep a list of all the products you use (including||
9336|115|I|prescription/nonprescription drugs and herbal products) and share||
9336|116|I|it with your doctor and pharmacist. Do not start, stop, or change||
9336|117|I|the dosage of any medicines without your doctor's approval.||
9336|118|B|||
9336|119|O|OVERDOSE:  This medicine may be harmful if swallowed. If someone||
9336|120|O|has overdosed and has serious symptoms such as passing out or||
9336|121|O|trouble breathing, call 911. Otherwise, call a poison control||
9336|122|O|center right away. US residents can call 1-800-222-1222. Canada||
9336|123|O|residents can call 1-844-764-7669.||
9336|124|B|||
9336|125|N|NOTES:  This medication has been prescribed for your current||
9336|126|N|condition only. Do not use it later for another condition unless||
9336|127|N|told to do so by your doctor. A different medication may be||
9336|128|N|necessary in that case.||
9336|129|B|||
9336|130|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember||
9336|131|D|unless it is almost time for the next dose. In that case, skip||
9336|132|D|the missed dose. Use your next dose at the regular time. Do not||
9336|133|D|double the dose to catch up.||
9336|134|B|||
9336|135|R|STORAGE:  Store at room temperature. Do not refrigerate. Keep all||
9336|136|R|medications away from children and pets.||
9336|137|R|   Do not flush medications down the toilet or pour them into a||
9336|138|R|drain unless instructed to do so. Properly discard this product||
9336|139|R|when it is expired or no longer needed. Consult your pharmacist||
9336|140|R|or local waste disposal company.||
9336|141|B|||
9336|142|A|Information last revised May 2025.||
9336|143|A|Copyright(c) 2025 First Databank, Inc.||
9336|144|B|||
9341|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9341|002|Z|does NOT have all possible information about this product. This||
9341|003|Z|information does not assure that this product is safe, effective,||
9341|004|Z|or appropriate for you. This information is not individual||
9341|005|Z|medical advice and does not substitute for the advice of your||
9341|006|Z|health care professional. Always ask your health care||
9341|007|Z|professional for complete information about this product and your||
9341|008|Z|specific health needs.||
9341|009|B|||
9341|010|T|ALEMTUZUMAB (MULTIPLE SCLEROSIS) - INJECTION||
9341|011|F|(AL-em-TOOZ-oo-mab)||
9341|012|B|||
9341|013|C|COMMON BRAND NAME(S): Lemtrada||
9341|014|B|||
9341|015|W|WARNING:  This medication may cause very serious (rarely fatal)||
9341|016|W|blood disorders (low number of blood cells such as red cells,||
9341|017|W|white cells, and platelets). This effect can cause anemia,||
9341|018|W|decrease your body's ability to fight an infection, or cause easy||
9341|019|W|bruising/bleeding. Tell your doctor right away if you develop any||
9341|020|W|of the following symptoms: signs of infection (such as sore||
9341|021|W|throat that doesn't go away, fever, chills, swollen lymph nodes),||
9341|022|W|easy bruising/bleeding, coughing up blood, shortness of breath,||
9341|023|W|unusual tiredness, fast/pounding heartbeat.||
9341|024|W|   This medication may also cause very serious kidney problems.||
9341|025|W|Tell your doctor right away if you notice symptoms such as change||
9341|026|W|in the amount of urine, painful urination, pink/bloody urine, or||
9341|027|W|swelling ankles/feet.||
9341|028|W|   Serious (rarely fatal) infusion reactions may happen during||
9341|029|W|the infusion of this drug and for 24 hours or more afterward.||
9341|030|W|Your doctor will prescribe other medications (such as||
9341|031|W|acetaminophen, diphenhydramine, corticosteroids) before each||
9341|032|W|treatment to help prevent these side effects. Tell your doctor||
9341|033|W|right away if you have any symptoms of infusion reactions such as||
9341|034|W|headache, fever, chills, flushing, mild rash/itching, nausea,||
9341|035|W|vomiting, shortness of breath, tiredness, or dizziness. Your||
9341|036|W|doctor may give you other medications to help with these side||
9341|037|W|effects.||
9341|038|W|   This medication may also cause a stroke, or tears in the blood||
9341|039|W|vessels in the head and neck, especially within the first 3 days||
9341|040|W|after receiving treatment. Get medical help right away if you||
9341|041|W|notice symptoms such as weakness on one side of the body,||
9341|042|W|drooping of the face, neck pain, sudden severe headache, trouble||
9341|043|W|speaking, sudden vision changes, or confusion.||
9341|044|W|   This medication may increase your risk of developing certain||
9341|045|W|types of cancer (such as thyroid, skin, blood). Tell your doctor||
9341|046|W|right away if you notice symptoms such as unusual growth or lump||
9341|047|W|in the neck, difficulty swallowing, unusual/lasting hoarseness,||
9341|048|W|unusual skin changes, change in appearance or size of moles.||
9341|049|W|   Your doctor will monitor you closely to decrease the risk of||
9341|050|W|these serious side effects.||
9341|051|W|   To receive alemtuzumab in the United States, you must||
9341|052|W|understand, agree to, and carefully follow the requirements of||
9341|053|W|the REMS Program for this medication. If you live in Canada or||
9341|054|W|any other country, consult your doctor and pharmacist for your||
9341|055|W|country's regulations.||
9341|056|B|||
9341|057|U|USES:  Alemtuzumab is used to treat multiple sclerosis (MS). It||
9341|058|U|is not a cure for MS but it is thought to help by preventing||
9341|059|U|immune system cells (lymphocytes) from attacking the nerves in||
9341|060|U|your brain and spinal cord. It helps decrease the number of||
9341|061|U|relapses and may prevent or delay disability.||
9341|062|B|||
9341|063|H|HOW TO USE:  Read the Medication Guide, Patient Safety||
9341|064|H|Information Card, and, if available, the Patient Information||
9341|065|H|Leaflet provided by your pharmacist before you start using||
9341|066|H|alemtuzumab and each time you receive treatment with this drug.||
9341|067|H|Carry the Patient Safety Information Card with you at all times.||
9341|068|H|If you have any questions, ask your doctor or pharmacist.||
9341|069|H|   This medication is given by injection into a vein over at||
9341|070|H|least 4 hours by a health care professional. It should be given||
9341|071|H|over 2 treatment courses. The first treatment course is usually||
9341|072|H|given daily for 5 days while the second treatment course is||
9341|073|H|usually given daily for 3 days. The treatment courses should be||
9341|074|H|separated by 12 months. Additional treatment courses of 3 days||
9341|075|H|may be given if needed, but should be separated by at least 12||
9341|076|H|months from the previous treatment.||
9341|077|H|   Before you receive this medication, your doctor will direct||
9341|078|H|you to take other medications (such as acetaminophen,||
9341|079|H|diphenhydramine, corticosteroids, antiviral medication) to help||
9341|080|H|prevent side effects and infection. Use these additional||
9341|081|H|medications exactly as prescribed by your doctor.||
9341|082|B|||
9341|083|S|SIDE EFFECTS:  See also Warning section.||
9341|084|S|   Diarrhea, stomach/abdominal pain, cough, trouble sleeping, or||
9341|085|S|mouth sores may occur. If any of these effects last or get worse,||
9341|086|S|tell your doctor or pharmacist promptly.||
9341|087|S|   People using this medication may have serious side effects.||
9341|088|S|However, you have been prescribed this drug because your doctor||
9341|089|S|has judged that the benefit to you is greater than the risk of||
9341|090|S|side effects. Careful monitoring by your doctor may decrease your||
9341|091|S|risk.||
9341|092|S|   Tell your doctor right away if you have any serious side||
9341|093|S|effects, including: diarrhea with blood/mucus, mental/mood||
9341|094|S|changes (such as depression, anxiety), muscle/bone/back pain,||
9341|095|S|joint pain/stiffness, signs of thyroid disease (such as unusual||
9341|096|S|weight changes, increased sweating, constipation, feeling cold,||
9341|097|S|fast/slow/irregular heartbeat), signs of liver disease (such as||
9341|098|S|nausea/vomiting that doesn't stop, loss of appetite, severe||
9341|099|S|stomach/abdominal pain, yellowing eyes/skin, dark urine).||
9341|100|S|   This medication may increase your risk of getting a rare but||
9341|101|S|very serious (possibly fatal) brain infection (progressive||
9341|102|S|multifocal leukoencephalopathy-PML). Get medical help right away||
9341|103|S|if you have any of these side effects: clumsiness, loss of||
9341|104|S|coordination/balance, weakness, sudden change in your thinking||
9341|105|S|(such as confusion, difficulty concentrating, memory loss),||
9341|106|S|difficulty talking/walking, seizure, vision changes.||
9341|107|S|   Get medical help right away if you have any very serious side||
9341|108|S|effects, including: fainting, chest/jaw/left arm pain.||
9341|109|S|   A very serious allergic reaction to this drug is rare.||
9341|110|S|However, get medical help right away if you notice any symptoms||
9341|111|S|of a serious allergic reaction, including: rash, itching/swelling||
9341|112|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9341|113|S|breathing.||
9341|114|S|   This is not a complete list of possible side effects. If you||
9341|115|S|notice other effects not listed above, contact your doctor or||
9341|116|S|pharmacist.||
9341|117|S|   In the US -||
9341|118|S|   Call your doctor for medical advice about side effects. You||
9341|119|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9341|120|S|www.fda.gov/medwatch.||
9341|121|S|   In Canada - Call your doctor for medical advice about side||
9341|122|S|effects. You may report side effects to Health Canada at||
9341|123|S|1-866-234-2345.||
9341|124|B|||
9341|125|P|PRECAUTIONS:  Before receiving alemtuzumab, tell your doctor or||
9341|126|P|pharmacist if you are allergic to it; or if you have any other||
9341|127|P|allergies. This product may contain inactive ingredients, which||
9341|128|P|can cause allergic reactions or other problems. Talk to your||
9341|129|P|pharmacist for more details.||
9341|130|P|   Before using this medication, tell your doctor or pharmacist||
9341|131|P|your medical history, especially of: immune system problems (such||
9341|132|P|as HIV), recent/current infections (such as tuberculosis),||
9341|133|P|bleeding/blood problems, high blood pressure, stroke, cancer,||
9341|134|P|kidney problems, heart problems, blood vessel problems (such as||
9341|135|P|tears in arteries), thyroid problems.||
9341|136|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9341|137|P|can make you more dizzy. Do not drive, use machinery, or do||
9341|138|P|anything that needs alertness until you can do it safely. Limit||
9341|139|P|alcoholic beverages. Talk to your doctor if you are using||
9341|140|P|marijuana (cannabis).||
9341|141|P|   Before having surgery, tell your doctor or dentist about all||
9341|142|P|the products you use (including prescription drugs,||
9341|143|P|nonprescription drugs, and herbal products).||
9341|144|P|   Before receiving a blood transfusion, tell your doctor that||
9341|145|P|you are using this medication.||
9341|146|P|   Tell your doctor your vaccine history and ask if you need to||
9341|147|P|get any vaccines before starting treatment with this medication.||
9341|148|P|Your doctor may direct you to have any required vaccines at least||
9341|149|P|6 weeks before starting this medication. Tell your health care||
9341|150|P|professional that you are using alemtuzumab before having any||
9341|151|P|immunizations/vaccinations. Avoid contact with people who have||
9341|152|P|recently received live vaccines (such as flu vaccine inhaled||
9341|153|P|through the nose).||
9341|154|P|   Wash your hands well to prevent the spread of infections.||
9341|155|P|   This medication also increases your risk of getting a very||
9341|156|P|serious infection caused by a bacteria called listeria. During||
9341|157|P|treatment and for some time after treatment with this medication,||
9341|158|P|either avoid food that may contain listeria (such as deli meat,||
9341|159|P|unpasteurized milk and cheese products, soft cheeses, undercooked||
9341|160|P|meat/seafood/poultry), or make sure you heat it well. Ask your||
9341|161|P|doctor for more details.||
9341|162|P|   To lower the chance of getting cut, bruised, or injured, use||
9341|163|P|caution with sharp objects like razors and nail cutters, and||
9341|164|P|avoid activities such as contact sports.||
9341|165|P|   Tell your doctor if you are pregnant or plan to become||
9341|166|P|pregnant. You should not become pregnant while using alemtuzumab.||
9341|167|P|Alemtuzumab may harm an unborn baby. Your doctor should order a||
9341|168|P|pregnancy test before you start this medication. Ask about||
9341|169|P|reliable forms of birth control while using this medication and||
9341|170|P|for 4 months after the last dose. If you become pregnant, talk to||
9341|171|P|your doctor right away about the risks and benefits of this||
9341|172|P|medication.||
9341|173|P|   It is unknown if this drug passes into breast milk. Because of||
9341|174|P|the possible risk to the infant, breastfeeding is not recommended||
9341|175|P|while using this drug and for at least 4 months after the last||
9341|176|P|dose. Consult your doctor before breastfeeding.||
9341|177|B|||
9341|178|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9341|179|I|medications work or increase your risk for serious side effects.||
9341|180|I|This document does not contain all possible drug interactions.||
9341|181|I|Keep a list of all the products you use (including||
9341|182|I|prescription/nonprescription drugs and herbal products) and share||
9341|183|I|it with your doctor and pharmacist. Do not start, stop, or change||
9341|184|I|the dosage of any medicines without your doctor's approval.||
9341|185|I|   Some products that may interact with this drug are: other||
9341|186|I|drugs that weaken the immune system/increase the risk of||
9341|187|I|infection (such as natalizumab, rituximab).||
9341|188|B|||
9341|189|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9341|190|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9341|191|O|poison control center right away. US residents can call||
9341|192|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9341|193|B|||
9341|194|N|NOTES:  Lab and/or medical tests (such as complete blood count,||
9341|195|N|EKG, kidney/liver/thyroid function, skin exams, tuberculosis||
9341|196|N|testing, urine tests) should be done before treatment, while you||
9341|197|N|are receiving this medication, and for some time after treatment||
9341|198|N|is completed. Keep all medical and lab appointments. Consult your||
9341|199|N|doctor for more details.||
9341|200|B|||
9341|201|D|MISSED DOSE:  It is important to get each dose of this medication||
9341|202|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9341|203|D|right away for a new dosing schedule.||
9341|204|B|||
9341|205|R|STORAGE:  Not applicable. This medication is given in a hospital||
9341|206|R|or clinic and will not be stored at home.||
9341|207|B|||
9341|208|M|MEDICAL ALERT:  Your condition can cause complications in a||
9341|209|M|medical emergency. For information about enrolling in MedicAlert,||
9341|210|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9341|211|B|||
9341|212|A|Information last revised May 2025.||
9341|213|A|Copyright(c) 2025 First Databank, Inc.||
9341|214|B|||
9342|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9342|002|Z|does NOT have all possible information about this product. This||
9342|003|Z|information does not assure that this product is safe, effective,||
9342|004|Z|or appropriate for you. This information is not individual||
9342|005|Z|medical advice and does not substitute for the advice of your||
9342|006|Z|health care professional. Always ask your health care||
9342|007|Z|professional for complete information about this product and your||
9342|008|Z|specific health needs.||
9342|009|B|||
9342|010|T|SORBITOL - ORAL, RECTAL||
9342|011|F|(SOR-bi-tole)||
9342|012|B|||
9342|013|U|USES:  This medication is used as a laxative to treat occasional||
9342|014|U|episodes of constipation.||
9342|015|U|   Depending on the brand, this product may be taken by mouth||
9342|016|U|and/or given rectally. Some products may only be given rectally.||
9342|017|U|Be sure to check the label on your product for how to take your||
9342|018|U|specific product.||
9342|019|B|||
9342|020|H|HOW TO USE:  If you are taking this medication by mouth, follow||
9342|021|H|your doctor's directions.||
9342|022|H|   If you are using this medication rectally, properly mix an||
9342|023|H|enema as directed by the product package or as directed by your||
9342|024|H|doctor.||
9342|025|H|   Do not use for longer than one week and do not take with||
9342|026|H|additional laxatives or stool softeners unless directed by your||
9342|027|H|doctor. Tell your doctor right away if your constipation is not||
9342|028|H|relieved after using this medication for one week.||
9342|029|H|   Laxatives should only be used temporarily until normal bowel||
9342|030|H|habits return. Prolonged use can lead to laxative dependence.||
9342|031|H|   If your condition lasts or gets worse, or if you think you may||
9342|032|H|have a serious medical problem, get medical help right away.||
9342|033|B|||
9342|034|S|SIDE EFFECTS:  Nausea, gas, diarrhea, stomach cramps or anal||
9342|035|S|irritation may occur. If any of these effects last or get worse,||
9342|036|S|tell your doctor or pharmacist promptly.||
9342|037|S|   If your doctor has directed you to use this medication,||
9342|038|S|remember that your doctor has judged that the benefit to you is||
9342|039|S|greater than the risk of side effects. Many people using this||
9342|040|S|medication do not have serious side effects.||
9342|041|S|   Tell your doctor right away if you have any serious side||
9342|042|S|effects, including: rectal bleeding, black stools, vomiting,||
9342|043|S|weakness, dizziness.||
9342|044|S|   A very serious allergic reaction to this drug is rare.||
9342|045|S|However, get medical help right away if you notice any symptoms||
9342|046|S|of a serious allergic reaction, including: rash, itching/swelling||
9342|047|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9342|048|S|breathing.||
9342|049|S|   This is not a complete list of possible side effects. If you||
9342|050|S|notice other effects not listed above, contact your doctor or||
9342|051|S|pharmacist.||
9342|052|S|   In the US -||
9342|053|S|   Call your doctor for medical advice about side effects. You||
9342|054|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9342|055|S|www.fda.gov/medwatch.||
9342|056|S|   In Canada - Call your doctor for medical advice about side||
9342|057|S|effects. You may report side effects to Health Canada at||
9342|058|S|1-866-234-2345.||
9342|059|B|||
9342|060|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
9342|061|P|pharmacist if you are allergic to it; or if you have any other||
9342|062|P|allergies. This product may contain inactive ingredients, which||
9342|063|P|can cause allergic reactions or other problems. Talk to your||
9342|064|P|pharmacist for more details.||
9342|065|P|   Before using this medication, tell your doctor or pharmacist||
9342|066|P|your medical history, especially of: undiagnosed stomach pain,||
9342|067|P|nausea/vomiting, rectal bleeding, a sudden change in bowel habits||
9342|068|P|lasting over 2 weeks.||
9342|069|P|   Before having surgery, tell your doctor or dentist about all||
9342|070|P|the products you use (including prescription drugs,||
9342|071|P|nonprescription drugs, and herbal products).||
9342|072|P|   Older adults may be more sensitive to the side effects of this||
9342|073|P|drug.||
9342|074|P|   Children may be more sensitive to the side effects of this||
9342|075|P|drug.||
9342|076|P|   During pregnancy, this medication should be used only when||
9342|077|P|clearly needed. Discuss the risks and benefits with your doctor.||
9342|078|P|   It is unknown if this drug passes into breast milk. Consult||
9342|079|P|your doctor before breastfeeding.||
9342|080|B|||
9342|081|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9342|082|I|medications work or increase your risk for serious side effects.||
9342|083|I|This document does not contain all possible drug interactions.||
9342|084|I|Keep a list of all the products you use (including||
9342|085|I|prescription/nonprescription drugs and herbal products) and share||
9342|086|I|it with your doctor and pharmacist. Do not start, stop, or change||
9342|087|I|the dosage of any medicines without your doctor's approval.||
9342|088|I|   Some products that may interact with this drug are:||
9342|089|I|lamivudine, sodium polystyrene sulfonate.||
9342|090|B|||
9342|091|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9342|092|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9342|093|O|poison control center right away. US residents can call||
9342|094|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9342|095|O|Symptoms of overdose may include: stomach cramps, diarrhea.||
9342|096|B|||
9342|097|N|NOTES:  Do not share this medication with others.||
9342|098|N|   Consult your doctor for a plan that is right for you to||
9342|099|N|prevent constipation. The plan may include drinking more fluids,||
9342|100|N|increasing bulk or fiber in your diet, and regular exercise.||
9342|101|B|||
9342|102|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9342|103|D|If it is near the time of the next dose, skip the missed dose.||
9342|104|D|Use your next dose at the regular time. Do not double the dose to||
9342|105|D|catch up.||
9342|106|B|||
9342|107|R|STORAGE:  Store at room temperature away from light. Keep all||
9342|108|R|medications away from children and pets.||
9342|109|R|   Do not flush medications down the toilet or pour them into a||
9342|110|R|drain unless instructed to do so. Properly discard this product||
9342|111|R|when it is expired or no longer needed. Consult your pharmacist||
9342|112|R|or local waste disposal company.||
9342|113|B|||
9342|114|A|Information last revised March 2025.||
9342|115|A|Copyright(c) 2025 First Databank, Inc.||
9342|116|B|||
9343|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9343|002|Z|does NOT have all possible information about this product. This||
9343|003|Z|information does not assure that this product is safe, effective,||
9343|004|Z|or appropriate for you. This information is not individual||
9343|005|Z|medical advice and does not substitute for the advice of your||
9343|006|Z|health care professional. Always ask your health care||
9343|007|Z|professional for complete information about this product and your||
9343|008|Z|specific health needs.||
9343|009|B|||
9343|010|T|CALCITRIOL - INJECTION||
9343|011|F|(KAL-si-TRYE-ol)||
9343|012|B|||
9343|013|C|COMMON BRAND NAME(S): Calcijex||
9343|014|B|||
9343|015|U|USES:  Calcitriol is a man-made active form of vitamin D (vitamin||
9343|016|U|D3). Vitamin D is a vitamin stored in the body that is needed for||
9343|017|U|building and keeping strong bones. Calcitriol is used to treat or||
9343|018|U|prevent certain problems that can happen with long-term kidney||
9343|019|U|dialysis, such as low levels of calcium or high levels of||
9343|020|U|parathyroid hormone. Calcitriol is usually used along with a||
9343|021|U|certain diet, supplements, and sometimes other medications.||
9343|022|U|   Most people get enough vitamin D from exposure to the sun and||
9343|023|U|from fortified food products (such as dairy products, vitamins).||
9343|024|U|Before regular vitamin D can be used by the body, it needs to be||
9343|025|U|changed to the active form by the liver and kidneys. People with||
9343|026|U|kidney disease cannot make enough of the active form of vitamin||
9343|027|U|D. This medication works by affecting parathyroid hormone (PTH)||
9343|028|U|levels and increasing blood calcium levels.||
9343|029|B|||
9343|030|H|HOW TO USE:  This medication is given by injection into a vein as||
9343|031|H|directed by your doctor, usually 3 times a week (every other day)||
9343|032|H|or during dialysis. The dosage is based on your condition and||
9343|033|H|response to treatment. Your doctor will do blood tests to find||
9343|034|H|the best dose for you.||
9343|035|H|   If you are giving this medication to yourself at home, learn||
9343|036|H|all preparation and usage instructions from your health care||
9343|037|H|professional. Before using, check this product for particles or||
9343|038|H|discoloration. If either is present, do not use the liquid. Learn||
9343|039|H|how to store and discard medical supplies safely.||
9343|040|H|   It is very important to follow the diet recommended by your||
9343|041|H|doctor to get the most benefit from this medication and to||
9343|042|H|prevent serious side effects. Do not take other||
9343|043|H|supplements/vitamins (such as calcium, vitamin D) unless directed||
9343|044|H|by your doctor.||
9343|045|B|||
9343|046|S|SIDE EFFECTS:  Nausea, headache, constipation, or pain/discomfort||
9343|047|S|at the injection site may occur. If any of these effects last or||
9343|048|S|get worse, tell your doctor promptly.||
9343|049|S|   Remember that this medication has been prescribed because your||
9343|050|S|doctor has judged that the benefit to you is greater than the||
9343|051|S|risk of side effects. Many people using this medication do not||
9343|052|S|have serious side effects.||
9343|053|S|   Tell your doctor right away if you have any serious side||
9343|054|S|effects, including: back/bone/joint/muscle pain, dry mouth,||
9343|055|S|metallic taste, vomiting, sleepiness, weakness, loss of appetite,||
9343|056|S|dizziness, eye pain/redness/sensitivity to light, fever,||
9343|057|S|fast/slow/irregular heartbeat, decreased interest in sex,||
9343|058|S|mental/mood changes (such as confusion), stomach/abdominal pain,||
9343|059|S|swelling of the ankles/feet/hands (edema), increased thirst,||
9343|060|S|signs of kidney problems (such as change in the amount of urine),||
9343|061|S|weight loss.||
9343|062|S|   A very serious allergic reaction to this drug is rare.||
9343|063|S|However, get medical help right away if you notice any symptoms||
9343|064|S|of a serious allergic reaction, including: rash, itching/swelling||
9343|065|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9343|066|S|breathing.||
9343|067|S|   This is not a complete list of possible side effects. If you||
9343|068|S|notice other effects not listed above, contact your doctor or||
9343|069|S|pharmacist.||
9343|070|S|   In the US -||
9343|071|S|   Call your doctor for medical advice about side effects. You||
9343|072|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9343|073|S|www.fda.gov/medwatch.||
9343|074|S|   In Canada - Call your doctor for medical advice about side||
9343|075|S|effects. You may report side effects to Health Canada at||
9343|076|S|1-866-234-2345.||
9343|077|B|||
9343|078|P|PRECAUTIONS:  Before using calcitriol, tell your doctor or||
9343|079|P|pharmacist if you are allergic to it; or to other vitamin D||
9343|080|P|products; or if you have any other allergies. This product may||
9343|081|P|contain inactive ingredients, which can cause allergic reactions||
9343|082|P|or other problems. Talk to your pharmacist for more details.||
9343|083|P|   Before using this medication, tell your doctor or pharmacist||
9343|084|P|your medical history, especially of: high calcium levels||
9343|085|P|(hypercalcemia), heart problems (such as irregular heartbeat,||
9343|086|P|coronary artery disease), kidney disease (such as kidney stones).||
9343|087|P|   Notify your doctor beforehand if you will be having surgery or||
9343|088|P|will be confined to a chair/bed (immobile) for a long time. Being||
9343|089|P|immobile for long periods increases your risk of side effects.||
9343|090|P|   Be sure to drink plenty of fluids unless otherwise directed by||
9343|091|P|your doctor.||
9343|092|P|   During pregnancy, this medication should be used only when||
9343|093|P|clearly needed. Discuss the risks and benefits with your doctor.||
9343|094|P|   It is unknown if this drug passes into breast milk. Consult||
9343|095|P|your doctor before breastfeeding.||
9343|096|B|||
9343|097|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9343|098|I|medications work or increase your risk for serious side effects.||
9343|099|I|This document does not contain all possible drug interactions.||
9343|100|I|Keep a list of all the products you use (including||
9343|101|I|prescription/nonprescription drugs and herbal products) and share||
9343|102|I|it with your doctor and pharmacist. Do not start, stop, or change||
9343|103|I|the dosage of any medicines without your doctor's approval.||
9343|104|I|   Some products that may interact with this drug include:||
9343|105|I|burosumab, cardiac glycosides (such as digoxin, digitalis),||
9343|106|I|magnesium-containing medications (such as antacids, milk of||
9343|107|I|magnesia), phosphate binders, vitamins/nutritional supplements||
9343|108|I|(especially calcium and vitamin D).||
9343|109|I|   Check the labels on all your prescription and||
9343|110|I|nonprescription/herbal products (such as antacids, laxatives,||
9343|111|I|vitamins) because they may contain calcium, magnesium, phosphate,||
9343|112|I|and vitamin D. Ask your pharmacist about using those products||
9343|113|I|safely.||
9343|114|I|   Calcitriol is very similar to other forms of vitamin D. Do not||
9343|115|I|use medications containing other forms of vitamin D while using||
9343|116|I|calcitriol.||
9343|117|B|||
9343|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9343|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9343|120|O|poison control center right away. US residents can call||
9343|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9343|122|O|Symptoms of overdose may include: irregular heartbeat, severe||
9343|123|O|stomach pain, unusually deep sleep.||
9343|124|B|||
9343|125|N|NOTES:  Lab and/or medical tests (such as calcium, magnesium,||
9343|126|N|phosphorus, parathyroid levels) should be done while you are||
9343|127|N|using this medication. Keep all medical and lab appointments.||
9343|128|N|Consult your doctor for more details.||
9343|129|N|   It is important to closely follow your doctor's diet orders||
9343|130|N|while taking this medication. Foods rich in vitamin D include:||
9343|131|N|fortified dairy products, eggs, sardines, cod liver oil, chicken||
9343|132|N|livers, and freshwater fish. Vitamin D is also obtained from||
9343|133|N|short periods of exposure to the sun. Calcium supplements may be||
9343|134|N|recommended in addition to this medication. The usual||
9343|135|N|recommendation for calcium is 600-1200 milligrams per day.||
9343|136|N|Discuss this with your doctor. Do not take supplements unless||
9343|137|N|directed by your doctor.||
9343|138|B|||
9343|139|D|MISSED DOSE:  It is important to get each dose of this medication||
9343|140|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9343|141|D|right away for a new dosing schedule. Do not double the dose to||
9343|142|D|catch up.||
9343|143|B|||
9343|144|R|STORAGE:  Store at room temperature away from light. Keep all||
9343|145|R|medications away from children and pets.||
9343|146|R|   Do not flush medications down the toilet or pour them into a||
9343|147|R|drain unless instructed to do so. Properly discard this product||
9343|148|R|when it is expired or no longer needed. Consult your pharmacist||
9343|149|R|or local waste disposal company.||
9343|150|B|||
9343|151|A|Information last revised December 2024.||
9343|152|A|Copyright(c) 2025 First Databank, Inc.||
9343|153|B|||
9347|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9347|002|Z|does NOT have all possible information about this product. This||
9347|003|Z|information does not assure that this product is safe, effective,||
9347|004|Z|or appropriate for you. This information is not individual||
9347|005|Z|medical advice and does not substitute for the advice of your||
9347|006|Z|health care professional. Always ask your health care||
9347|007|Z|professional for complete information about this product and your||
9347|008|Z|specific health needs.||
9347|009|B|||
9347|010|T|ELETRIPTAN - ORAL||
9347|011|F|(EL-e-TRIP-tan)||
9347|012|B|||
9347|013|C|COMMON BRAND NAME(S): Relpax||
9347|014|B|||
9347|015|U|USES:  Eletriptan is used to treat migraines. It helps to relieve||
9347|016|U|headache, pain, and other migraine symptoms (including nausea,||
9347|017|U|vomiting, sensitivity to light/sound). Prompt treatment helps you||
9347|018|U|return to your normal routine and may decrease your need for||
9347|019|U|other pain medications. Eletriptan belongs to a class of drugs||
9347|020|U|known as triptans. It affects a certain natural substance||
9347|021|U|(serotonin) that causes narrowing of blood vessels in the brain.||
9347|022|U|It may also relieve pain by affecting certain nerves in the||
9347|023|U|brain.||
9347|024|U|   Eletriptan does not prevent future migraines or lessen how||
9347|025|U|often you get migraine attacks.||
9347|026|B|||
9347|027|H|HOW TO USE:  Read the Patient Information Leaflet available from||
9347|028|H|your pharmacist before you start using eletriptan and each time||
9347|029|H|you get a refill. If you have any questions, ask your doctor or||
9347|030|H|pharmacist.||
9347|031|H|   Take this medication by mouth with or without food as directed||
9347|032|H|by your doctor, at the first sign of a migraine. The dosage is||
9347|033|H|based on your medical condition and response to treatment. If||
9347|034|H|there is no improvement in your symptoms, do not take more doses||
9347|035|H|of this medication before talking to your doctor. If your||
9347|036|H|symptoms are only partly relieved, or if your headache comes||
9347|037|H|back, you may take another dose two hours after the first dose.||
9347|038|H|For the US product, do not take more than 80 milligrams in a||
9347|039|H|24-hour period. For the Canadian product, the manufacturer||
9347|040|H|recommends a maximum of 40 milligrams in a 24-hour period.||
9347|041|H|   If you have a higher risk for heart problems (see||
9347|042|H|Precautions), your doctor may perform a heart exam before you||
9347|043|H|start taking eletriptan. He/she may also direct you to take your||
9347|044|H|first dose of this medication in the office/clinic to monitor for||
9347|045|H|serious side effects (such as chest pain). Talk to your doctor||
9347|046|H|for details.||
9347|047|H|   If you are using drugs for migraine attacks on 10 or more days||
9347|048|H|each month, the drugs may actually make your headaches worse||
9347|049|H|(medication overuse headache). Do not use medications more often||
9347|050|H|or for longer than directed. Tell your doctor if you need to use||
9347|051|H|this medication more often, or if the medication is not working||
9347|052|H|as well, or if your headaches get worse.||
9347|053|B|||
9347|054|S|SIDE EFFECTS:  Nausea, feelings of tingling/numbness, weakness,||
9347|055|S|tiredness, drowsiness, or dizziness may occur. If any of these||
9347|056|S|effects last or get worse, tell your doctor or pharmacist||
9347|057|S|promptly.||
9347|058|S|   Remember that this medication has been prescribed because your||
9347|059|S|doctor has judged that the benefit to you is greater than the||
9347|060|S|risk of side effects. Many people using this medication do not||
9347|061|S|have serious side effects.||
9347|062|S|   This medication may raise your blood pressure. Check your||
9347|063|S|blood pressure regularly and tell your doctor if the results are||
9347|064|S|high.||
9347|065|S|   Tell your doctor right away if you have any serious side||
9347|066|S|effects, including: blue fingers/toes/nails, cold hands/feet.||
9347|067|S|   Eletriptan can commonly cause chest/jaw/neck tightness, pain,||
9347|068|S|or pressure that is usually not serious. However, these side||
9347|069|S|effects are like symptoms of a heart attack, which may include||
9347|070|S|chest/jaw/left arm pain, shortness of breath, or unusual||
9347|071|S|sweating. Get medical help right away if these or other serious||
9347|072|S|side effects occur, including: fast/irregular heartbeat,||
9347|073|S|fainting, severe stomach/abdominal pain, bloody diarrhea, signs||
9347|074|S|of a stroke (such as weakness on one side of the body, trouble||
9347|075|S|speaking, sudden vision changes, confusion).||
9347|076|S|   This medication may increase serotonin and rarely cause a very||
9347|077|S|serious condition called serotonin syndrome/toxicity. The risk||
9347|078|S|increases if you are also taking other drugs that increase||
9347|079|S|serotonin, so tell your doctor or pharmacist of all the drugs you||
9347|080|S|take (see Drug Interactions section). Get medical help right away||
9347|081|S|if you develop some of the following symptoms: fast heartbeat,||
9347|082|S|hallucinations, loss of coordination, severe dizziness, severe||
9347|083|S|nausea/vomiting/diarrhea, twitching muscles, unexplained fever,||
9347|084|S|unusual agitation/restlessness.||
9347|085|S|   A very serious allergic reaction to this drug is rare.||
9347|086|S|However, get medical help right away if you notice any symptoms||
9347|087|S|of a serious allergic reaction, including: rash, itching/swelling||
9347|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9347|089|S|breathing.||
9347|090|S|   This is not a complete list of possible side effects. If you||
9347|091|S|notice other effects not listed above, contact your doctor or||
9347|092|S|pharmacist.||
9347|093|S|   In the US -||
9347|094|S|   Call your doctor for medical advice about side effects. You||
9347|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9347|096|S|www.fda.gov/medwatch.||
9347|097|S|   In Canada - Call your doctor for medical advice about side||
9347|098|S|effects. You may report side effects to Health Canada at||
9347|099|S|1-866-234-2345.||
9347|100|B|||
9347|101|P|PRECAUTIONS:  Before taking eletriptan, tell your doctor or||
9347|102|P|pharmacist if you are allergic to it; or if you have any other||
9347|103|P|allergies. This product may contain inactive ingredients, which||
9347|104|P|can cause allergic reactions or other problems. Talk to your||
9347|105|P|pharmacist for more details.||
9347|106|P|   Before using this medication, tell your doctor or pharmacist||
9347|107|P|your medical history, especially of: blood circulation problems||
9347|108|P|(for example, in your legs, arms/hands, or stomach), certain||
9347|109|P|types of headaches (hemiplegic or basilar migraine), heart||
9347|110|P|problems (such as chest pain, irregular heartbeat, previous heart||
9347|111|P|attack), liver disease, seizure, stroke or "mini-stroke"||
9347|112|P|(transient ischemic attack).||
9347|113|P|   Certain conditions can increase your risk for heart problems.||
9347|114|P|Tell your doctor if you have any of these conditions, including:||
9347|115|P|high blood pressure, high cholesterol, diabetes, family history||
9347|116|P|of heart disease, overweight, smoker, postmenopausal (women), age||
9347|117|P|more than 40 years (men).||
9347|118|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9347|119|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9347|120|P|machinery, or do anything that needs alertness until you can do||
9347|121|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9347|122|P|are using marijuana (cannabis).||
9347|123|P|   Before having surgery, tell your doctor or dentist about all||
9347|124|P|the products you use (including prescription drugs,||
9347|125|P|nonprescription drugs, and herbal products).||
9347|126|P|   The risk of heart disease and high blood pressure increases||
9347|127|P|with age. Older adults may be more sensitive to the side effects||
9347|128|P|of this drug, especially increased blood pressure and heart||
9347|129|P|problems.||
9347|130|P|   During pregnancy, this medication should be used only when||
9347|131|P|clearly needed. Discuss the risks and benefits with your doctor.||
9347|132|P|   This drug passes into breast milk. Consult your doctor before||
9347|133|P|breastfeeding.||
9347|134|B|||
9347|135|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9347|136|I|medications work or increase your risk for serious side effects.||
9347|137|I|This document does not contain all possible drug interactions.||
9347|138|I|Keep a list of all the products you use (including||
9347|139|I|prescription/nonprescription drugs and herbal products) and share||
9347|140|I|it with your doctor and pharmacist. Do not start, stop, or change||
9347|141|I|the dosage of any medicines without your doctor's approval.||
9347|142|I|   Avoid taking certain medications that can affect the removal||
9347|143|I|of eletriptan from your body within 72 hours of taking||
9347|144|I|eletriptan. Examples include cobicistat, nefazodone, ribociclib,||
9347|145|I|ritonavir, azole antifungals (such as ketoconazole,||
9347|146|I|itraconazole), macrolide antibiotics (such as clarithromycin,||
9347|147|I|erythromycin), HIV protease inhibitors (such as nelfinavir),||
9347|148|I|among others.||
9347|149|I|   If you also take any ergotamine medication (such as||
9347|150|I|dihydroergotamine) or other "triptan" drugs (such as sumatriptan,||
9347|151|I|rizatriptan), separate your eletriptan dose at least 24 hours||
9347|152|I|apart from your dose of these other medications to lessen the||
9347|153|I|chance of serious side effects.||
9347|154|I|   The risk of serotonin syndrome/toxicity increases if you are||
9347|155|I|also taking other drugs that increase serotonin. Examples include||
9347|156|I|street drugs such as MDMA/"ecstasy," St. John's wort, certain||
9347|157|I|antidepressants (including SSRIs such as fluoxetine/paroxetine,||
9347|158|I|SNRIs such as duloxetine/venlafaxine), among others. The risk of||
9347|159|I|serotonin syndrome/toxicity may be more likely when you start or||
9347|160|I|increase the dose of these drugs.||
9347|161|B|||
9347|162|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9347|163|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9347|164|O|poison control center right away. US residents can call||
9347|165|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9347|166|B|||
9347|167|N|NOTES:  Do not share this medication with others.||
9347|168|N|   Certain foods, beverages, or food additives (such as red wine,||
9347|169|N|cheese, chocolate, monosodium glutamate) as well as lifestyle||
9347|170|N|patterns such as irregular eating/sleeping habits or stress may||
9347|171|N|bring on a migraine headache. Avoiding these "triggers" may help||
9347|172|N|lessen migraine attacks. Consult your doctor for more details.||
9347|173|N|   Lab and/or medical tests (such as blood pressure) may be done||
9347|174|N|while you are taking this medication. Keep all medical and lab||
9347|175|N|appointments. Consult your doctor for more details.||
9347|176|B|||
9347|177|D|MISSED DOSE:  Not applicable. (See How to Use section.)||
9347|178|B|||
9347|179|R|STORAGE:  Store at room temperature away from light and moisture.||
9347|180|R|Do not store in the bathroom. Keep all medications away from||
9347|181|R|children and pets.||
9347|182|R|   Do not flush medications down the toilet or pour them into a||
9347|183|R|drain unless instructed to do so. Properly discard this product||
9347|184|R|when it is expired or no longer needed. Consult your pharmacist||
9347|185|R|or local waste disposal company.||
9347|186|B|||
9347|187|A|Information last revised May 2024.||
9347|188|A|Copyright(c) 2025 First Databank, Inc.||
9347|189|B|||
9352|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9352|002|Z|does NOT have all possible information about this product. This||
9352|003|Z|information does not assure that this product is safe, effective,||
9352|004|Z|or appropriate for you. This information is not individual||
9352|005|Z|medical advice and does not substitute for the advice of your||
9352|006|Z|health care professional. Always ask your health care||
9352|007|Z|professional for complete information about this product and your||
9352|008|Z|specific health needs.||
9352|009|B|||
9352|010|T|MORPHINE EXTENDED-RELEASE CAPSULE - ORAL||
9352|011|F|(MORE-feen)||
9352|012|B|||
9352|013|C|COMMON BRAND NAME(S): Avinza||
9352|014|B|||
9352|015|W|WARNING:  Morphine has a risk for abuse and addiction, which can||
9352|016|W|lead to overdose and death. Morphine may also cause severe,||
9352|017|W|possibly fatal, breathing problems. To lower your risk, your||
9352|018|W|doctor should have you take the smallest dose of morphine that||
9352|019|W|works, and take it for the shortest possible time. See also How||
9352|020|W|to Use section for more information about addiction.||
9352|021|W|   Ask your doctor or pharmacist if you should have medication||
9352|022|W|available to treat opioid overdose (such as naloxone, nalmefene).||
9352|023|W|Teach your family or household members about the signs of an||
9352|024|W|opioid overdose and how to treat it.||
9352|025|W|   The risk for severe breathing problems is higher when you||
9352|026|W|start this medication and after a dose increase, or if you take||
9352|027|W|the wrong dose/strength. Taking this medication with alcohol or||
9352|028|W|other drugs that can cause drowsiness or breathing problems may||
9352|029|W|cause very serious side effects, including death. Be sure you||
9352|030|W|know how to take morphine and what other drugs you should avoid||
9352|031|W|taking with it. See also Drug Interactions section. Get medical||
9352|032|W|help right away if any of these very serious side effects occur:||
9352|033|W|slow/shallow breathing, unusual lightheadedness, severe||
9352|034|W|drowsiness/dizziness, difficulty waking up.||
9352|035|W|   Do not crush, chew, or dissolve this medication or the||
9352|036|W|contents of the capsules. Also, do not drink alcohol or use any||
9352|037|W|product that contains alcohol while taking this medication.||
9352|038|W|Drinking alcohol with this medication or taking crushed, chewed,||
9352|039|W|or dissolved forms of extended-release morphine could cause a||
9352|040|W|fatal overdose.||
9352|041|W|   Keep this medicine in a safe place to prevent theft, misuse,||
9352|042|W|or abuse. If someone accidentally swallows this drug, get medical||
9352|043|W|help right away.||
9352|044|W|   Before using this medication, women of childbearing age should||
9352|045|W|talk with their doctor(s) about the risks and benefits. Tell your||
9352|046|W|doctor if you are pregnant or if you plan to become pregnant.||
9352|047|W|During pregnancy, this medication should be used only when||
9352|048|W|clearly needed. It may slightly increase the risk of birth||
9352|049|W|defects if used during the first two months of pregnancy. Also,||
9352|050|W|using it for a long time or in high doses near the expected||
9352|051|W|delivery date may harm the unborn baby. To lessen the risk, take||
9352|052|W|the smallest effective dose for the shortest possible time.||
9352|053|W|Babies born to mothers who use this drug for a long time may||
9352|054|W|develop severe (possibly fatal) withdrawal symptoms. Tell the||
9352|055|W|doctor right away if you notice any symptoms in your newborn baby||
9352|056|W|such as crying that doesn't stop, slow/shallow breathing,||
9352|057|W|irritability, shaking, vomiting, diarrhea, poor feeding, or||
9352|058|W|difficulty gaining weight.||
9352|059|B|||
9352|060|U|USES:  This medication is used to help relieve severe ongoing||
9352|061|U|pain (such as due to cancer). Morphine belongs to a class of||
9352|062|U|drugs known as opioid analgesics. It works in the brain to change||
9352|063|U|how your body feels and responds to pain.||
9352|064|U|   The higher strengths of this drug (90 and 120 milligrams per||
9352|065|U|capsule) should be used only if you have been regularly taking||
9352|066|U|moderate to large amounts of an opioid pain medication. These||
9352|067|U|strengths may cause overdose (even death) if taken by a person||
9352|068|U|who has not been regularly taking opioids.||
9352|069|U|   Do not use the extended-release form of morphine to relieve||
9352|070|U|pain that is mild or that will go away in a few days. This||
9352|071|U|medication is not for occasional ("as needed") use.||
9352|072|B|||
9352|073|H|HOW TO USE:  See also Warning section.||
9352|074|H|   Read the Medication Guide provided by your pharmacist before||
9352|075|H|you start using morphine and each time you get a refill. If you||
9352|076|H|have any questions, consult your doctor or pharmacist.||
9352|077|H|   Take this medication on a regular schedule as directed by your||
9352|078|H|doctor, not as needed for sudden (breakthrough) pain. Take this||
9352|079|H|drug with or without food, usually once daily (every 24 hours).||
9352|080|H|If you have nausea, it may help to take this drug with food. Ask||
9352|081|H|your doctor or pharmacist about other ways to decrease nausea||
9352|082|H|(such as lying down for 1 to 2 hours with as little head movement||
9352|083|H|as possible).||
9352|084|H|   Swallow the capsules whole. Adults who have trouble swallowing||
9352|085|H|the capsule may open the capsule and carefully sprinkle its||
9352|086|H|contents on a spoonful of soft, cool applesauce. Swallow all of||
9352|087|H|the drug/food mixture right away without chewing. Then rinse your||
9352|088|H|mouth and swallow the rinse liquid to make sure that you have||
9352|089|H|swallowed all of the dose. Do not chew the mixture or prepare a||
9352|090|H|supply in advance. Do not give this medication to a child this||
9352|091|H|way, since they might chew the mixture and overdose. For children||
9352|092|H|who have trouble swallowing the capsule, ask the doctor about||
9352|093|H|using a different form of morphine instead.||
9352|094|H|   Because of the risk for overdose, do not give this medication||
9352|095|H|down a feeding tube.||
9352|096|H|   The dosage is based on your medical condition and response to||
9352|097|H|treatment. Do not increase your dose, take the medication more||
9352|098|H|often, or take it for a longer time than prescribed. Properly||
9352|099|H|stop the medication when so directed.||
9352|100|H|   The maximum recommended dose of this medication is 1600||
9352|101|H|milligrams per 24-hour period. Taking more than the maximum dose||
9352|102|H|might increase the risk of damage to your kidneys from an||
9352|103|H|ingredient in this medication (fumaric acid).||
9352|104|H|   Before you start taking this medication, ask your doctor or||
9352|105|H|pharmacist if you should stop or change how you use your other||
9352|106|H|opioid medication(s). Other pain relievers (such as||
9352|107|H|acetaminophen, ibuprofen) may also be prescribed. Ask your doctor||
9352|108|H|or pharmacist about using morphine safely with other drugs.||
9352|109|H|   Suddenly stopping this medication may cause withdrawal,||
9352|110|H|especially if you have used it for a long time or in high doses.||
9352|111|H|To prevent withdrawal, your doctor may lower your dose slowly.||
9352|112|H|Tell your doctor or pharmacist right away if you have any||
9352|113|H|withdrawal symptoms such as restlessness, mental/mood changes||
9352|114|H|(including anxiety, trouble sleeping, thoughts of suicide),||
9352|115|H|watering eyes, runny nose, nausea, diarrhea, sweating, muscle||
9352|116|H|aches, or sudden changes in behavior.||
9352|117|H|   When this medication is used for a long time, it may not work||
9352|118|H|as well. Talk with your doctor if this medication stops working||
9352|119|H|well.||
9352|120|H|   Though it helps many people, this medication may sometimes||
9352|121|H|cause addiction. This risk may be higher if you have a||
9352|122|H|mental/mood disorder or a substance use disorder (such as overuse||
9352|123|H|of or addiction to drugs/alcohol). Take this medication exactly||
9352|124|H|as prescribed to lower the risk of addiction. Ask your doctor or||
9352|125|H|pharmacist for more details.||
9352|126|H|   Tell your doctor if your pain does not get better or if it||
9352|127|H|gets worse, or if you have any new pain.||
9352|128|B|||
9352|129|S|SIDE EFFECTS:  See also Warning section.||
9352|130|S|   Nausea, vomiting, constipation, lightheadedness, dizziness, or||
9352|131|S|drowsiness may occur. Some of these side effects may decrease||
9352|132|S|after you have been using this medication for a while. If any of||
9352|133|S|these effects last or get worse, tell your doctor or pharmacist||
9352|134|S|promptly.||
9352|135|S|   To prevent constipation, eat dietary fiber, drink enough||
9352|136|S|water, and exercise. You may also need to take a laxative. Ask||
9352|137|S|your pharmacist which type of laxative is right for you.||
9352|138|S|   To reduce the risk of dizziness and lightheadedness, get up||
9352|139|S|slowly when rising from a sitting or lying position.||
9352|140|S|   Remember that this medication has been prescribed because your||
9352|141|S|doctor has judged that the benefit to you is greater than the||
9352|142|S|risk of side effects. Many people using this medication do not||
9352|143|S|have serious side effects.||
9352|144|S|   Tell your doctor right away if you have any serious side||
9352|145|S|effects, including: interrupted breathing during sleep (sleep||
9352|146|S|apnea), mental/mood changes (such as agitation, confusion,||
9352|147|S|hallucinations), severe stomach/abdominal pain, difficulty||
9352|148|S|urinating, signs of your adrenal glands not working well (such as||
9352|149|S|loss of appetite, unusual tiredness, weight loss), trouble||
9352|150|S|swallowing.||
9352|151|S|   Get medical help right away if you have any very serious side||
9352|152|S|effects, including: fainting, seizure, slow/shallow breathing,||
9352|153|S|severe drowsiness/difficulty waking up.||
9352|154|S|   A very serious allergic reaction to this drug is rare.||
9352|155|S|However, get medical help right away if you notice any symptoms||
9352|156|S|of a serious allergic reaction, including: rash, itching/swelling||
9352|157|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9352|158|S|breathing.||
9352|159|S|   This is not a complete list of possible side effects. If you||
9352|160|S|notice other effects not listed above, contact your doctor or||
9352|161|S|pharmacist.||
9352|162|S|   In the US -||
9352|163|S|   Call your doctor for medical advice about side effects. You||
9352|164|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9352|165|S|www.fda.gov/medwatch.||
9352|166|S|   In Canada - Call your doctor for medical advice about side||
9352|167|S|effects. You may report side effects to Health Canada at||
9352|168|S|1-866-234-2345.||
9352|169|B|||
9352|170|P|PRECAUTIONS:  Before taking morphine, tell your doctor or||
9352|171|P|pharmacist if you are allergic to it; or to other opioid pain||
9352|172|P|medications (such as codeine); or if you have any other||
9352|173|P|allergies. This product may contain inactive ingredients, which||
9352|174|P|can cause allergic reactions or other problems. Talk to your||
9352|175|P|pharmacist for more details.||
9352|176|P|   Before using this medication, tell your doctor or pharmacist||
9352|177|P|your medical history, especially of: brain disorders (such as||
9352|178|P|head injury, tumor, seizures), breathing problems (such as||
9352|179|P|asthma, sleep apnea, chronic obstructive pulmonary disease-COPD),||
9352|180|P|kidney disease, liver disease, mental/mood disorders (such as||
9352|181|P|confusion, depression), personal or family history of a substance||
9352|182|P|use disorder (such as overuse of or addiction to drugs/alcohol),||
9352|183|P|stomach/intestinal problems (such as blockage, constipation,||
9352|184|P|diarrhea due to infection, paralytic ileus), difficulty urinating||
9352|185|P|(such as due to enlarged prostate), disease of the pancreas||
9352|186|P|(pancreatitis), gallbladder disease.||
9352|187|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9352|188|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9352|189|P|machinery, or do anything that needs alertness until you can do||
9352|190|P|it safely. Avoid alcoholic beverages. Talk to your doctor if you||
9352|191|P|are using marijuana (cannabis).||
9352|192|P|   Before having surgery, tell your doctor or dentist about all||
9352|193|P|the products you use (including prescription drugs,||
9352|194|P|nonprescription drugs, and herbal products).||
9352|195|P|   Older adults may be more sensitive to the side effects of this||
9352|196|P|drug, especially confusion, dizziness, drowsiness, and||
9352|197|P|slow/shallow breathing.||
9352|198|P|   During pregnancy, this medication should be used only when||
9352|199|P|clearly needed. It may harm an unborn baby. Discuss the risks and||
9352|200|P|benefits with your doctor. (See also Warning section.)||
9352|201|P|   This drug passes into breast milk and may have undesirable||
9352|202|P|effects on a nursing infant. Tell the doctor right away if your||
9352|203|P|baby develops unusual sleepiness, difficulty feeding, or trouble||
9352|204|P|breathing. Consult your doctor before breastfeeding.||
9352|205|B|||
9352|206|I|DRUG INTERACTIONS:  See also Warning section.||
9352|207|I|   Drug interactions may change how your medications work or||
9352|208|I|increase your risk for serious side effects. This document does||
9352|209|I|not contain all possible drug interactions. Keep a list of all||
9352|210|I|the products you use (including prescription/nonprescription||
9352|211|I|drugs and herbal products) and share it with your doctor and||
9352|212|I|pharmacist. Do not start, stop, or change the dosage of any||
9352|213|I|medicines without your doctor's approval.||
9352|214|I|   Some products that may interact with this drug include:||
9352|215|I|certain pain medications (mixed opioid agonist-antagonists such||
9352|216|I|as butorphanol, nalbuphine, pentazocine), naltrexone, products||
9352|217|I|that contain alcohol (such as cough-and-cold syrups),||
9352|218|I|samidorphan.||
9352|219|I|   The risk of serious side effects (such as slow/shallow||
9352|220|I|breathing, severe drowsiness/dizziness) may be increased if this||
9352|221|I|medication is taken with other products that may also cause||
9352|222|I|drowsiness or breathing problems. Tell your doctor or pharmacist||
9352|223|I|if you are taking other products such as other opioid pain or||
9352|224|I|cough relievers (such as codeine, hydrocodone), alcohol,||
9352|225|I|marijuana (cannabis), drugs for sleep or anxiety (such as||
9352|226|I|alprazolam, lorazepam, zolpidem), muscle relaxants (such as||
9352|227|I|carisoprodol, cyclobenzaprine), or antihistamines (such as||
9352|228|I|cetirizine, diphenhydramine).||
9352|229|I|   Check the labels on all your medicines (such as allergy or||
9352|230|I|cough-and-cold products) because they may contain ingredients||
9352|231|I|that cause drowsiness. Ask your pharmacist about using those||
9352|232|I|products safely.||
9352|233|I|   This medication may interfere with certain lab tests (such as||
9352|234|I|amylase/lipase levels), possibly causing false test results. Make||
9352|235|I|sure lab personnel and all your doctors know you use this drug.||
9352|236|B|||
9352|237|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9352|238|O|as passing out or trouble breathing, give them naloxone or||
9352|239|O|nalmefene if available, then call 911. If the person is awake and||
9352|240|O|has no symptoms, call a poison control center right away. US||
9352|241|O|residents can call 1-800-222-1222. Canada residents can call||
9352|242|O|1-844-764-7669. Symptoms of overdose may include: slow/shallow||
9352|243|O|breathing, slow heartbeat, coma.||
9352|244|B|||
9352|245|N|NOTES:  Do not share this medication with others. Sharing it is||
9352|246|N|against the law.||
9352|247|N|   This medication has been prescribed for your current condition||
9352|248|N|only. Do not use it later for another condition unless told to do||
9352|249|N|so by your doctor. A different medication may be necessary in||
9352|250|N|that case.||
9352|251|B|||
9352|252|D|MISSED DOSE:  If you miss a dose, skip the missed dose. Take your||
9352|253|D|next dose at the regular time. Do not double the dose to catch||
9352|254|D|up.||
9352|255|B|||
9352|256|R|STORAGE:  Store at room temperature away from light and moisture.||
9352|257|R|Do not store in the bathroom. Keep all medications away from||
9352|258|R|children and pets. See also Warning section.||
9352|259|R|   Do not flush medications down the toilet or pour them into a||
9352|260|R|drain unless instructed to do so. Properly discard this product||
9352|261|R|when it is expired or no longer needed. For more details, read||
9352|262|R|the Medication Guide, or consult your pharmacist or local waste||
9352|263|R|disposal company.||
9352|264|B|||
9352|265|A|Information last revised August 2025.||
9352|266|A|Copyright(c) 2025 First Databank, Inc.||
9352|267|B|||
9357|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9357|002|Z|does NOT have all possible information about this product. This||
9357|003|Z|information does not assure that this product is safe, effective,||
9357|004|Z|or appropriate for you. This information is not individual||
9357|005|Z|medical advice and does not substitute for the advice of your||
9357|006|Z|health care professional. Always ask your health care||
9357|007|Z|professional for complete information about this product and your||
9357|008|Z|specific health needs.||
9357|009|B|||
9357|010|T|PROPYLENE GLYCOL/POLYETHYLENE GLYCOL SPRAY - NASAL||
9357|011|F|(PROE-pi-leen glycol/pol-ee-ETH-ih-lean glycol)||
9357|012|B|||
9357|013|C|COMMON BRAND NAME(S): Rhinaris||
9357|014|B|||
9357|015|U|USES:  This product is used to treat dryness and irritation||
9357|016|U|inside the nose (nasal passages) caused by dry room air,||
9357|017|U|medications, allergies, colds, or other conditions. This product||
9357|018|U|helps add moisture inside the nose to dissolve and soften thick||
9357|019|U|or crusty mucus, making it easier to remove the mucus. This helps||
9357|020|U|to prevent nosebleeds, relieve a stuffy nose, and make breathing||
9357|021|U|easier.||
9357|022|U|   This product contains moisturizers in a gentle purified salt||
9357|023|U|solution (also called saline or sodium chloride solution). It||
9357|024|U|does not contain any medication.||
9357|025|B|||
9357|026|H|HOW TO USE:  Spray this product into each nostril, usually every||
9357|027|H|4 hours or as needed. Follow all directions on the product||
9357|028|H|package. If you have any questions, ask your doctor or||
9357|029|H|pharmacist.||
9357|030|H|   If your condition lasts or gets worse, or if you think you may||
9357|031|H|have a serious medical problem, get medical help right away.||
9357|032|B|||
9357|033|S|SIDE EFFECTS:  Side effects usually do not occur with use of this||
9357|034|S|product. However, if the inside of your nose is very dry and||
9357|035|S|irritated, mild stinging may occur. If this effect lasts or gets||
9357|036|S|worse, tell your doctor or pharmacist promptly.||
9357|037|S|   If your doctor has directed you to use this medication,||
9357|038|S|remember that your doctor has judged that the benefit to you is||
9357|039|S|greater than the risk of side effects. Many people using this||
9357|040|S|medication do not have serious side effects.||
9357|041|S|   A very serious allergic reaction to this drug is rare.||
9357|042|S|However, get medical help right away if you notice any symptoms||
9357|043|S|of a serious allergic reaction, including: rash, itching/swelling||
9357|044|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9357|045|S|breathing.||
9357|046|S|   This is not a complete list of possible side effects. If you||
9357|047|S|notice other effects not listed above, contact your doctor or||
9357|048|S|pharmacist.||
9357|049|S|   In the US -||
9357|050|S|   Call your doctor for medical advice about side effects. You||
9357|051|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9357|052|S|www.fda.gov/medwatch.||
9357|053|S|   In Canada - Call your doctor for medical advice about side||
9357|054|S|effects. You may report side effects to Health Canada at||
9357|055|S|1-866-234-2345.||
9357|056|B|||
9357|057|P|PRECAUTIONS:  Before using this product, tell your doctor or||
9357|058|P|pharmacist if you are allergic to any of its ingredients; or if||
9357|059|P|you have any other allergies. This product may contain inactive||
9357|060|P|ingredients, which can cause allergic reactions or other||
9357|061|P|problems. Talk to your pharmacist for more details.||
9357|062|P|   This product is safe to use during pregnancy.||
9357|063|P|   This product is safe to use if you are breastfeeding.||
9357|064|B|||
9357|065|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9357|066|I|medications work or increase your risk for serious side effects.||
9357|067|I|This document does not contain all possible drug interactions.||
9357|068|I|Keep a list of all the products you use (including||
9357|069|I|prescription/nonprescription drugs and herbal products) and share||
9357|070|I|it with your doctor and pharmacist. Do not start, stop, or change||
9357|071|I|the dosage of any medicines without your doctor's approval.||
9357|072|B|||
9357|073|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9357|074|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9357|075|O|poison control center right away. US residents can call||
9357|076|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9357|077|B|||
9357|078|N|NOTES:  Do not share this product with others. Doing so may||
9357|079|N|increase the risk of infection.||
9357|080|B|||
9357|081|D|MISSED DOSE:  Not applicable.||
9357|082|B|||
9357|083|R|STORAGE:  Refer to storage information printed on the package. If||
9357|084|R|you have any questions about storage, ask your pharmacist. Keep||
9357|085|R|all medications away from children and pets.||
9357|086|R|   Do not flush medications down the toilet or pour them into a||
9357|087|R|drain unless instructed to do so. Properly discard this product||
9357|088|R|when it is expired or no longer needed. Consult your pharmacist||
9357|089|R|or local waste disposal company.||
9357|090|B|||
9357|091|A|Information last revised September 2024.||
9357|092|A|Copyright(c) 2025 First Databank, Inc.||
9357|093|B|||
9358|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9358|002|Z|does NOT have all possible information about this product. This||
9358|003|Z|information does not assure that this product is safe, effective,||
9358|004|Z|or appropriate for you. This information is not individual||
9358|005|Z|medical advice and does not substitute for the advice of your||
9358|006|Z|health care professional. Always ask your health care||
9358|007|Z|professional for complete information about this product and your||
9358|008|Z|specific health needs.||
9358|009|B|||
9358|010|T|TREPROSTINIL - INJECTION||
9358|011|F|(tre-PROS-ti-nil)||
9358|012|B|||
9358|013|C|COMMON BRAND NAME(S): Remodulin||
9358|014|B|||
9358|015|U|USES:  This medication is used to treat a type of high blood||
9358|016|U|pressure in the lungs (pulmonary arterial hypertension).||
9358|017|U|Treprostinil helps to improve symptoms such as shortness of||
9358|018|U|breath and tiredness. It works by relaxing and widening the blood||
9358|019|U|vessels (arteries) in the lungs and other parts of the body so||
9358|020|U|that blood can flow more easily. This medication belongs to a||
9358|021|U|class of drugs known as vasodilators.||
9358|022|B|||
9358|023|H|HOW TO USE:  When you first start using this medication, it must||
9358|024|H|be given by a health care professional in a hospital or clinic.||
9358|025|H|This medication is given as a continuous injection, usually under||
9358|026|H|the skin using an infusion pump. If you cannot receive the drug||
9358|027|H|under the skin, it may be mixed with an IV solution and given||
9358|028|H|into a vein using an infusion pump. The dosage is based on your||
9358|029|H|medical condition, weight, and response to treatment. Your doctor||
9358|030|H|may direct you to use other medications in addition to||
9358|031|H|treprostinil to treat your condition and to prevent problems. Use||
9358|032|H|all prescribed medications exactly as directed.||
9358|033|H|   Your health care professional will prepare and mix the||
9358|034|H|solution for you according to the manufacturer's instructions. If||
9358|035|H|you are using this medication at home, learn all preparation and||
9358|036|H|usage instructions from your health care professional. Before||
9358|037|H|using, check this product for particles or discoloration. If||
9358|038|H|either is present, do not use the liquid, and contact your health||
9358|039|H|care professional right away. Learn how to store and discard||
9358|040|H|medical supplies safely.||
9358|041|H|   Do not suddenly decrease the dose or suddenly stop using this||
9358|042|H|medication because doing either may lead to serious (rarely||
9358|043|H|fatal) worsening of your condition. If you must stop this||
9358|044|H|medication, gradually reduce the dose as directed by your doctor.||
9358|045|H|Consult your doctor right away if your infusion is interrupted or||
9358|046|H|if you develop worsening trouble breathing, dizziness, or||
9358|047|H|weakness. To avoid interruptions in drug treatment, you should||
9358|048|H|have a backup infusion pump and infusion sets available in case||
9358|049|H|your equipment fails. Consult your health care professional for||
9358|050|H|more information.||
9358|051|H|   Tell your doctor if your condition does not get better or if||
9358|052|H|it gets worse.||
9358|053|B|||
9358|054|S|SIDE EFFECTS:  Nausea, vomiting, diarrhea, headache, dizziness,||
9358|055|S|jaw pain, flushing, loss of appetite, weakness, abdominal pain,||
9358|056|S|and redness/swelling/pain at the injection site may occur. If any||
9358|057|S|of these effects last or get worse, tell your doctor or||
9358|058|S|pharmacist promptly.||
9358|059|S|   To reduce the risk of dizziness and lightheadedness, get up||
9358|060|S|slowly when rising from a sitting or lying position.||
9358|061|S|   Remember that this medication has been prescribed because your||
9358|062|S|doctor has judged that the benefit to you is greater than the||
9358|063|S|risk of side effects. Many people using this medication do not||
9358|064|S|have serious side effects.||
9358|065|S|   Tell your doctor right away if you have any serious side||
9358|066|S|effects, including: new/worsening swelling of the arms/legs,||
9358|067|S|mental/mood changes (such as restlessness, nervousness), unusual||
9358|068|S|bleeding/bruising.||
9358|069|S|   To avoid infection, follow your health care professional's||
9358|070|S|instructions for proper handling of this medication. Tell your||
9358|071|S|doctor right away if you develop any signs of infection (such as||
9358|072|S|fever, chills).||
9358|073|S|   A very serious allergic reaction to this drug is rare.||
9358|074|S|However, get medical help right away if you notice any symptoms||
9358|075|S|of a serious allergic reaction, including: rash, itching/swelling||
9358|076|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9358|077|S|breathing.||
9358|078|S|   This is not a complete list of possible side effects. If you||
9358|079|S|notice other effects not listed above, contact your doctor or||
9358|080|S|pharmacist.||
9358|081|S|   In the US -||
9358|082|S|   Call your doctor for medical advice about side effects. You||
9358|083|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9358|084|S|www.fda.gov/medwatch.||
9358|085|S|   In Canada - Call your doctor for medical advice about side||
9358|086|S|effects. You may report side effects to Health Canada at||
9358|087|S|1-866-234-2345.||
9358|088|B|||
9358|089|P|PRECAUTIONS:  Before using treprostinil, tell your doctor or||
9358|090|P|pharmacist if you are allergic to it; or if you have any other||
9358|091|P|allergies. This product may contain inactive ingredients, which||
9358|092|P|can cause allergic reactions or other problems. Talk to your||
9358|093|P|pharmacist for more details.||
9358|094|P|   Before using this medication, tell your doctor or pharmacist||
9358|095|P|your medical history, especially of: liver problems, bleeding||
9358|096|P|problems.||
9358|097|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9358|098|P|can make you more dizzy. Do not drive, use machinery, or do||
9358|099|P|anything that needs alertness until you can do it safely. Limit||
9358|100|P|alcoholic beverages. Talk to your doctor if you are using||
9358|101|P|marijuana (cannabis).||
9358|102|P|   Before having surgery, tell your doctor or dentist about all||
9358|103|P|the products you use (including prescription drugs,||
9358|104|P|nonprescription drugs, and herbal products).||
9358|105|P|   During pregnancy, this medication should be used only when||
9358|106|P|clearly needed. Discuss the risks and benefits with your doctor.||
9358|107|P|   This medication passes into breast milk. Consult your doctor||
9358|108|P|before breastfeeding.||
9358|109|B|||
9358|110|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9358|111|I|medications work or increase your risk for serious side effects.||
9358|112|I|This document does not contain all possible drug interactions.||
9358|113|I|Keep a list of all the products you use (including||
9358|114|I|prescription/nonprescription drugs and herbal products) and share||
9358|115|I|it with your doctor and pharmacist. Do not start, stop, or change||
9358|116|I|the dosage of any medicines without your doctor's approval.||
9358|117|B|||
9358|118|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9358|119|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9358|120|O|poison control center right away. US residents can call||
9358|121|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9358|122|O|Symptoms of overdose may include: severe dizziness, fainting.||
9358|123|B|||
9358|124|N|NOTES:  Do not share this medication with others.||
9358|125|N|   Lab and/or medical tests (such as blood pressure) may be done||
9358|126|N|while you are using this medication. Keep all medical and lab||
9358|127|N|appointments. Consult your doctor for more details.||
9358|128|B|||
9358|129|D|MISSED DOSE:  This drug is to be given continuously as an||
9358|130|D|infusion. If your infusion is interrupted, contact your doctor or||
9358|131|D|pharmacist right away.||
9358|132|B|||
9358|133|R|STORAGE:  Store unopened vials at room temperature. Consult your||
9358|134|R|pharmacist for details about the storage of opened vials and||
9358|135|R|prepared solutions. Keep all medications away from children and||
9358|136|R|pets.||
9358|137|R|   Do not flush medications down the toilet or pour them into a||
9358|138|R|drain unless instructed to do so. Properly discard this product||
9358|139|R|when it is expired or no longer needed. Consult your pharmacist||
9358|140|R|or local waste disposal company.||
9358|141|B|||
9358|142|M|MEDICAL ALERT:  Your condition can cause complications in a||
9358|143|M|medical emergency. For information about enrolling in MedicAlert,||
9358|144|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9358|145|B|||
9358|146|A|Information last revised August 2025.||
9358|147|A|Copyright(c) 2025 First Databank, Inc.||
9358|148|B|||
9368|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9368|002|Z|does NOT have all possible information about this product. This||
9368|003|Z|information does not assure that this product is safe, effective,||
9368|004|Z|or appropriate for you. This information is not individual||
9368|005|Z|medical advice and does not substitute for the advice of your||
9368|006|Z|health care professional. Always ask your health care||
9368|007|Z|professional for complete information about this product and your||
9368|008|Z|specific health needs.||
9368|009|B|||
9368|010|T|IBUPROFEN - ORAL||
9368|011|F|(EYE-bue-PROE-fen)||
9368|012|B|||
9368|013|C|COMMON BRAND NAME(S):  Motrin, Advil, Nuprin||
9368|014|B|||
9368|015|W|WARNING:  Nonsteroidal anti-inflammatory drugs (including||
9368|016|W|ibuprofen) may rarely increase the risk for a heart attack or||
9368|017|W|stroke. This effect can happen at any time while taking this drug||
9368|018|W|but is more likely if you take it for a long time. The risk may||
9368|019|W|be greater in older adults or if you have heart disease or||
9368|020|W|increased risk for heart disease (for example, due to smoking,||
9368|021|W|family history of heart disease, or conditions such as high blood||
9368|022|W|pressure or diabetes). Do not take this drug right before or||
9368|023|W|after heart bypass surgery (CABG).||
9368|024|W|   This drug may rarely cause serious (rarely fatal) bleeding||
9368|025|W|from the stomach or intestines. This effect can occur without||
9368|026|W|warning at any time while taking this drug. Older adults may be||
9368|027|W|at higher risk for this effect.||
9368|028|W|   Stop taking ibuprofen and get medical help right away if you||
9368|029|W|notice any of these rare but serious side effects:||
9368|030|W|stomach/abdominal pain that doesn't go away, black/tarry stools,||
9368|031|W|vomit that looks like coffee grounds, chest/jaw/left arm pain,||
9368|032|W|shortness of breath, unusual sweating, confusion, weakness on one||
9368|033|W|side of the body, trouble speaking, sudden vision changes.||
9368|034|W|   Talk to your doctor or pharmacist about the benefits and risks||
9368|035|W|of taking this drug.||
9368|036|B|||
9368|037|U|USES:  Ibuprofen is used to relieve pain from various conditions||
9368|038|U|such as headache, dental pain, menstrual cramps, muscle aches, or||
9368|039|U|arthritis. It is also used to reduce fever and to relieve minor||
9368|040|U|aches and pain due to the common cold or flu. Ibuprofen is a||
9368|041|U|nonsteroidal anti-inflammatory drug (NSAID). It works by blocking||
9368|042|U|your body's production of certain natural substances that cause||
9368|043|U|inflammation. This effect helps to decrease swelling, pain, or||
9368|044|U|fever.||
9368|045|U|   If you are treating a chronic condition such as arthritis, ask||
9368|046|U|your doctor about non-drug treatments and/or using other||
9368|047|U|medications to treat your pain. See also Warning section.||
9368|048|U|   Check the ingredients on the label even if you have used the||
9368|049|U|product before. The manufacturer may have changed the||
9368|050|U|ingredients. Also, products with similar names may contain||
9368|051|U|different ingredients meant for different purposes. Taking the||
9368|052|U|wrong product could harm you.||
9368|053|B|||
9368|054|V|OTHER USES:  This section contains uses of this drug that are not||
9368|055|V|listed in the approved professional labeling for the drug but||
9368|056|V|that may be prescribed by your health care professional. Use this||
9368|057|V|drug for a condition that is listed in this section only if it||
9368|058|V|has been so prescribed by your health care professional.||
9368|059|V|   This drug may also be used for gout attacks.||
9368|060|B|||
9368|061|H|HOW TO USE:  If you are taking the over-the-counter product, read||
9368|062|H|all directions on the product package before taking this||
9368|063|H|medication. If your doctor has prescribed this medication, read||
9368|064|H|the Medication Guide provided by your pharmacist before you start||
9368|065|H|taking ibuprofen and each time you get a refill. If you have any||
9368|066|H|questions, ask your doctor or pharmacist.||
9368|067|H|   Take this medication by mouth, usually every 4 to 6 hours with||
9368|068|H|a full glass of water (8 ounces/240 milliliters) unless your||
9368|069|H|doctor directs you otherwise. Do not lie down for at least 10||
9368|070|H|minutes after taking this drug. If you have stomach upset while||
9368|071|H|taking this medication, take it with food, milk, or an antacid.||
9368|072|H|   The dosage is based on your medical condition and response to||
9368|073|H|treatment. To reduce your risk of stomach bleeding and other side||
9368|074|H|effects, take this medication at the lowest effective dose for||
9368|075|H|the shortest possible time. Do not increase your dose or take||
9368|076|H|this drug more often than directed by your doctor or the package||
9368|077|H|label. For ongoing conditions such as arthritis, keep taking this||
9368|078|H|medication as directed by your doctor.||
9368|079|H|   Children's dosage is based on weight. Read the package||
9368|080|H|directions to find the proper dose for your child's weight.||
9368|081|H|Consult the pharmacist or doctor if you have questions or if you||
9368|082|H|need help choosing a nonprescription product.||
9368|083|H|   For certain conditions (such as arthritis), it may take up to||
9368|084|H|two weeks of taking this drug regularly until you get the full||
9368|085|H|benefit.||
9368|086|H|   If you are taking this drug "as needed" (not on a regular||
9368|087|H|schedule), remember that pain medications work best if they are||
9368|088|H|used as the first signs of pain occur. If you wait until the pain||
9368|089|H|has worsened, the medication may not work as well.||
9368|090|H|   Tell your doctor if your condition lasts or gets worse or if||
9368|091|H|you have a fever that lasts for more than 3 days. If you think||
9368|092|H|you may have a serious medical problem, get medical help right||
9368|093|H|away.||
9368|094|B|||
9368|095|S|SIDE EFFECTS:  See also Warning section.||
9368|096|S|   Upset stomach, nausea, vomiting, headache, diarrhea,||
9368|097|S|constipation, dizziness, or drowsiness may occur. If any of these||
9368|098|S|effects last or get worse, tell your doctor or pharmacist||
9368|099|S|promptly.||
9368|100|S|   If your doctor has prescribed this medication, remember that||
9368|101|S|your doctor has judged that the benefit to you is greater than||
9368|102|S|the risk of side effects. Many people using this medication do||
9368|103|S|not have serious side effects.||
9368|104|S|   This medication may raise your blood pressure. Check your||
9368|105|S|blood pressure regularly and tell your doctor if the results are||
9368|106|S|high.||
9368|107|S|   Tell your doctor right away if you have any serious side||
9368|108|S|effects, including: easy bruising/bleeding, hearing changes (such||
9368|109|S|as ringing in the ears), mental/mood changes, unexplained stiff||
9368|110|S|neck, signs of kidney problems (such as change in the amount of||
9368|111|S|urine), vision changes, symptoms of heart failure (such as||
9368|112|S|swelling ankles/feet, unusual tiredness, unusual/sudden weight||
9368|113|S|gain).||
9368|114|S|   This drug may rarely cause serious (possibly fatal) liver||
9368|115|S|disease. Get medical help right away if you have any symptoms of||
9368|116|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
9368|117|S|of appetite, dark urine, stomach/abdominal pain, yellowing||
9368|118|S|eyes/skin.||
9368|119|S|   A very serious allergic reaction to this drug is rare.||
9368|120|S|However, get medical help right away if you notice any symptoms||
9368|121|S|of a serious allergic reaction, including: fever, swollen lymph||
9368|122|S|nodes, rash, itching/swelling (especially of the||
9368|123|S|face/tongue/throat), severe dizziness, trouble breathing.||
9368|124|S|   This is not a complete list of possible side effects. If you||
9368|125|S|notice other effects not listed above, contact your doctor or||
9368|126|S|pharmacist.||
9368|127|S|   In the US -||
9368|128|S|   Call your doctor for medical advice about side effects. You||
9368|129|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9368|130|S|www.fda.gov/medwatch.||
9368|131|S|   In Canada - Call your doctor for medical advice about side||
9368|132|S|effects. You may report side effects to Health Canada at||
9368|133|S|1-866-234-2345.||
9368|134|B|||
9368|135|P|PRECAUTIONS:  Before taking ibuprofen, tell your doctor or||
9368|136|P|pharmacist if you are allergic to it; or to aspirin or other||
9368|137|P|NSAIDs (such as naproxen, celecoxib); or if you have any other||
9368|138|P|allergies. This product may contain inactive ingredients, which||
9368|139|P|can cause allergic reactions or other problems. Talk to your||
9368|140|P|pharmacist for more details.||
9368|141|P|   Before taking this medication, tell your doctor or pharmacist||
9368|142|P|your medical history, especially of: asthma (including a history||
9368|143|P|of worsening breathing after taking aspirin or other NSAIDs),||
9368|144|P|blood disorders (such as anemia, bleeding/clotting problems),||
9368|145|P|growths in the nose (nasal polyps), heart disease (such as||
9368|146|P|previous heart attack), high blood pressure, liver disease,||
9368|147|P|stroke, throat/stomach/intestinal problems (such as bleeding,||
9368|148|P|heartburn, ulcers).||
9368|149|P|   Kidney problems can sometimes occur with the use of NSAID||
9368|150|P|medications, including ibuprofen. Problems are more likely to||
9368|151|P|occur if you are dehydrated, have heart failure or kidney||
9368|152|P|disease, are an older adult, or if you take certain medications||
9368|153|P|(see also Drug Interactions section). Drink plenty of fluids as||
9368|154|P|directed by your doctor to prevent dehydration and tell your||
9368|155|P|doctor right away if you have a change in the amount of urine.||
9368|156|P|   This drug may make you dizzy or drowsy. Alcohol or marijuana||
9368|157|P|(cannabis) can make you more dizzy or drowsy. Do not drive, use||
9368|158|P|machinery, or do anything that needs alertness until you can do||
9368|159|P|it safely. Limit alcoholic beverages. Talk to your doctor if you||
9368|160|P|are using marijuana (cannabis).||
9368|161|P|   This medicine may cause stomach bleeding. Daily use of alcohol||
9368|162|P|and tobacco, especially when combined with this medicine, may||
9368|163|P|increase your risk for stomach bleeding. Limit alcohol and stop||
9368|164|P|smoking. Consult your doctor or pharmacist for more information.||
9368|165|P|   This medication may make you more sensitive to the sun. Limit||
9368|166|P|your time in the sun. Avoid tanning booths and sunlamps. Use||
9368|167|P|sunscreen and wear protective clothing when outdoors. Tell your||
9368|168|P|doctor right away if you get sunburned or have skin||
9368|169|P|blisters/redness.||
9368|170|P|   Before having surgery, tell your doctor or dentist about all||
9368|171|P|the products you use (including prescription drugs,||
9368|172|P|nonprescription drugs, and herbal products).||
9368|173|P|   Older adults may be at greater risk for stomach/intestinal||
9368|174|P|bleeding, kidney problems, heart attack, and stroke while using||
9368|175|P|this drug.||
9368|176|P|   Before using this medication, women of childbearing age should||
9368|177|P|talk with their doctor(s) about the benefits and risks. Tell your||
9368|178|P|doctor if you are pregnant or if you plan to become pregnant.||
9368|179|P|This medication may harm an unborn baby and cause problems with||
9368|180|P|normal labor/delivery. It is not recommended for use in pregnancy||
9368|181|P|from 20 weeks until delivery. If your doctor decides that you||
9368|182|P|need to use this medication between 20 and 30 weeks of pregnancy,||
9368|183|P|you should use the lowest effective dose for the shortest||
9368|184|P|possible time. You should not use this medication after 30 weeks||
9368|185|P|of pregnancy.||
9368|186|P|   This medication passes into breast milk, but is unlikely to||
9368|187|P|harm a nursing infant. Consult your doctor before breastfeeding.||
9368|188|B|||
9368|189|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9368|190|I|medications work or increase your risk for serious side effects.||
9368|191|I|This document does not contain all possible drug interactions.||
9368|192|I|Keep a list of all the products you use (including||
9368|193|I|prescription/nonprescription drugs and herbal products) and share||
9368|194|I|it with your doctor and pharmacist. Do not start, stop, or change||
9368|195|I|the dosage of any medicines without your doctor's approval.||
9368|196|I|   Some products that may interact with this drug include:||
9368|197|I|aliskiren, ACE inhibitors (such as captopril, lisinopril),||
9368|198|I|angiotensin II receptor blockers (such as losartan, valsartan),||
9368|199|I|cidofovir, corticosteroids (such as prednisone), lithium, "water||
9368|200|I|pills" (diuretics such as furosemide).||
9368|201|I|   This medication may increase the risk of bleeding when taken||
9368|202|I|with other drugs that also may cause bleeding. Examples include||
9368|203|I|anti-platelet drugs such as clopidogrel, "blood thinners" such as||
9368|204|I|dabigatran/enoxaparin/warfarin, among others.||
9368|205|I|   Check all prescription and nonprescription medicine labels||
9368|206|I|carefully since many medications contain pain relievers/fever||
9368|207|I|reducers (including aspirin, NSAIDs such as celecoxib, ketorolac,||
9368|208|I|or naproxen). These drugs are similar to ibuprofen and may||
9368|209|I|increase your risk of side effects if taken together. However, if||
9368|210|I|your doctor has told you to take low-dose aspirin to prevent||
9368|211|I|heart attack or stroke (usually 81-162 milligrams a day), you||
9368|212|I|should keep taking the aspirin unless your doctor tells you not||
9368|213|I|to. Daily use of ibuprofen may decrease aspirin's ability to||
9368|214|I|prevent heart attack/stroke. Talk to your doctor about using a||
9368|215|I|different medication (such as acetaminophen) to treat pain/fever.||
9368|216|I|If you must take ibuprofen, talk to your doctor about taking||
9368|217|I|immediate-release aspirin (not enteric-coated/EC) while taking||
9368|218|I|ibuprofen. Take ibuprofen at least 8 hours before or at least 2||
9368|219|I|hours after your aspirin dose. Do not increase your daily dose of||
9368|220|I|aspirin or change the way you take aspirin/other medications||
9368|221|I|without your doctor's approval.||
9368|222|B|||
9368|223|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9368|224|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9368|225|O|poison control center right away. US residents can call||
9368|226|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9368|227|O|Symptoms of overdose may include: severe stomach pain, trouble||
9368|228|O|breathing, extreme drowsiness.||
9368|229|B|||
9368|230|N|NOTES:  If your doctor has prescribed this medication, do not||
9368|231|N|share it with others.||
9368|232|N|   Lab and/or medical tests (such as blood pressure, kidney||
9368|233|N|function) may be done while you are taking this medication. Keep||
9368|234|N|all medical and lab appointments. Consult your doctor for more||
9368|235|N|details.||
9368|236|B|||
9368|237|D|MISSED DOSE:  If you are taking this drug on a regular schedule||
9368|238|D|(not just "as needed") and you miss a dose, take it as soon as||
9368|239|D|you remember. If it is near the time of the next dose, skip the||
9368|240|D|missed dose. Take your next dose at the regular time. Do not||
9368|241|D|double the dose to catch up.||
9368|242|B|||
9368|243|R|STORAGE:  Store at room temperature away from light and moisture.||
9368|244|R|Do not store in the bathroom. Keep all medications away from||
9368|245|R|children and pets.||
9368|246|R|   Do not flush medications down the toilet or pour them into a||
9368|247|R|drain unless instructed to do so. Properly discard this product||
9368|248|R|when it is expired or no longer needed. Consult your pharmacist||
9368|249|R|or local waste disposal company.||
9368|250|B|||
9368|251|A|Information last revised November 2024.||
9368|252|A|Copyright(c) 2025 First Databank, Inc.||
9368|253|B|||
9369|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9369|002|Z|does NOT have all possible information about this product. This||
9369|003|Z|information does not assure that this product is safe, effective,||
9369|004|Z|or appropriate for you. This information is not individual||
9369|005|Z|medical advice and does not substitute for the advice of your||
9369|006|Z|health care professional. Always ask your health care||
9369|007|Z|professional for complete information about this product and your||
9369|008|Z|specific health needs.||
9369|009|B|||
9369|010|T|BORTEZOMIB - INJECTION||
9369|011|F|(bor-TEZ-oh-mib)||
9369|012|B|||
9369|013|C|COMMON BRAND NAME(S): Boruzu, Velcade||
9369|014|B|||
9369|015|U|USES:  This medication is used to treat certain types of cancer||
9369|016|U|(such as multiple myeloma, mantle cell lymphoma). It works by||
9369|017|U|slowing or stopping the growth of cancer cells.||
9369|018|B|||
9369|019|H|HOW TO USE:  This medication is given by injection into a vein or||
9369|020|H|under the skin by a health care professional. If you are||
9369|021|H|receiving this medication under the skin, make sure that the||
9369|022|H|injection site is changed each time to lessen injury under the||
9369|023|H|skin. Your doctor may direct you to receive this medication in a||
9369|024|H|treatment cycle (for example, only on certain days each month).||
9369|025|H|Carefully follow your doctor's instructions. The dosage is based||
9369|026|H|on your body size, medical condition, lab tests, and response to||
9369|027|H|treatment.||
9369|028|H|   To prevent dehydration, it is important to drink plenty of||
9369|029|H|fluids while you are being treated with this drug. Consult your||
9369|030|H|doctor or pharmacist if you have any questions.||
9369|031|B|||
9369|032|S|SIDE EFFECTS:  Dizziness, lightheadedness, nausea, vomiting, loss||
9369|033|S|of appetite, diarrhea, constipation, tiredness, weakness, or||
9369|034|S|pain/redness at the injection site may occur. Nausea, vomiting,||
9369|035|S|and diarrhea can be severe. In some cases, your doctor may||
9369|036|S|prescribe medication to prevent or relieve nausea, vomiting, and||
9369|037|S|diarrhea. If any of these effects last or get worse, tell your||
9369|038|S|doctor or pharmacist promptly.||
9369|039|S|   To reduce the risk of dizziness and lightheadedness, get up||
9369|040|S|slowly when rising from a sitting or lying position.||
9369|041|S|   People using this medication may have serious side effects.||
9369|042|S|However, you have been prescribed this drug because your doctor||
9369|043|S|has judged that the benefit to you is greater than the risk of||
9369|044|S|side effects. Careful monitoring by your doctor may decrease your||
9369|045|S|risk.||
9369|046|S|   Bortezomib sometimes causes side effects due to the rapid||
9369|047|S|destruction of cancer cells (tumor lysis syndrome). To lower your||
9369|048|S|risk, your doctor may add a medication and tell you to drink||
9369|049|S|plenty of fluids. Tell your doctor right away if you have||
9369|050|S|symptoms such as: low back/side pain (flank pain), signs of||
9369|051|S|kidney problems (such as painful urination, pink/bloody urine,||
9369|052|S|change in the amount of urine), muscle spasms/weakness.||
9369|053|S|   Tell your doctor right away if you have any serious side||
9369|054|S|effects, including: tingling/numbness/pain/burning feeling of||
9369|055|S|arms/legs, severe headache, mental/mood changes (such as||
9369|056|S|confusion), signs of liver disease (such as nausea/vomiting that||
9369|057|S|doesn't stop, loss of appetite, stomach/abdominal pain, yellowing||
9369|058|S|eyes/skin, dark urine), symptoms of heart failure (such as||
9369|059|S|shortness of breath, swelling ankles/feet, unusual tiredness,||
9369|060|S|unusual/sudden weight gain).||
9369|061|S|   Get medical help right away if you have any very serious side||
9369|062|S|effects, including: chest pain, vision changes, seizures,||
9369|063|S|weakness on one side of the body, trouble speaking, fainting,||
9369|064|S|small red/purple/brown spots on your skin.||
9369|065|S|   This medication can decrease blood cells, which can cause||
9369|066|S|anemia, decrease your body's ability to fight an infection, or||
9369|067|S|cause easy bruising/bleeding. Tell your doctor right away if you||
9369|068|S|develop any of the following symptoms: easy bleeding/bruising,||
9369|069|S|black/tarry stools, vomit that looks like coffee grounds, signs||
9369|070|S|of an infection (such as sore throat that doesn't go away, fever,||
9369|071|S|chills), unusual tiredness, pale skin.||
9369|072|S|   A very serious allergic reaction to this drug is rare.||
9369|073|S|However, get medical help right away if you notice any symptoms||
9369|074|S|of a serious allergic reaction, including: rash, itching/swelling||
9369|075|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9369|076|S|breathing.||
9369|077|S|   Bortezomib can commonly cause a rash that is usually not||
9369|078|S|serious. However, you may not be able to tell it apart from a||
9369|079|S|rare rash that could be a sign of a severe reaction. Get medical||
9369|080|S|help right away if you develop any rash.||
9369|081|S|   This is not a complete list of possible side effects. If you||
9369|082|S|notice other effects not listed above, contact your doctor or||
9369|083|S|pharmacist.||
9369|084|S|   In the US -||
9369|085|S|   Call your doctor for medical advice about side effects. You||
9369|086|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9369|087|S|www.fda.gov/medwatch.||
9369|088|S|   In Canada - Call your doctor for medical advice about side||
9369|089|S|effects. You may report side effects to Health Canada at||
9369|090|S|1-866-234-2345.||
9369|091|B|||
9369|092|P|PRECAUTIONS:  Before using this medication, tell your doctor or||
9369|093|P|pharmacist if you are allergic to it; or if you have any other||
9369|094|P|allergies. This product may contain inactive ingredients (such as||
9369|095|P|boron, mannitol), which can cause allergic reactions or other||
9369|096|P|problems. Talk to your pharmacist for more details.||
9369|097|P|   Before using this medication, tell your doctor or pharmacist||
9369|098|P|your medical history, especially of: nerve problems (such as||
9369|099|P|peripheral neuropathy), liver disease, kidney disease,||
9369|100|P|dehydration, heart disease (such as heart failure),||
9369|101|P|bleeding/blood disorders, current/recent infections, diabetes.||
9369|102|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9369|103|P|can make you more dizzy. Do not drive, use machinery, or do||
9369|104|P|anything that needs alertness until you can do it safely. Limit||
9369|105|P|alcoholic beverages. Talk to your doctor if you are using||
9369|106|P|marijuana (cannabis).||
9369|107|P|   Before having surgery, tell your doctor or dentist about all||
9369|108|P|the products you use (including prescription drugs,||
9369|109|P|nonprescription drugs, and herbal products).||
9369|110|P|   Bortezomib can make you more likely to get infections or may||
9369|111|P|make current infections worse. Stay away from anyone who has an||
9369|112|P|infection that may easily spread (such as chickenpox, COVID-19,||
9369|113|P|measles, flu). Talk to your doctor if you have been exposed to an||
9369|114|P|infection or for more details.||
9369|115|P|   Tell your health care professional that you are using||
9369|116|P|bortezomib before having any immunizations/vaccinations. Avoid||
9369|117|P|contact with people who have recently received live vaccines||
9369|118|P|(such as flu vaccine inhaled through the nose).||
9369|119|P|   To lower the chance of getting cut, bruised, or injured, use||
9369|120|P|caution with sharp objects like razors and nail cutters, and||
9369|121|P|avoid activities such as contact sports.||
9369|122|P|   Tell your doctor if you are pregnant or plan to become||
9369|123|P|pregnant. You should not become pregnant while using bortezomib.||
9369|124|P|Bortezomib may harm an unborn baby. Your doctor should order a||
9369|125|P|pregnancy test before you start this medication. Women using this||
9369|126|P|medication should ask about reliable forms of birth control||
9369|127|P|during treatment and for 7 months after the last dose. Men using||
9369|128|P|this medication should ask about reliable forms of birth control||
9369|129|P|during treatment and for 4 months after the last dose. If you or||
9369|130|P|your partner becomes pregnant, talk to your doctor right away||
9369|131|P|about the risks and benefits of this medication.||
9369|132|P|   It is unknown if this drug passes into breast milk. Because of||
9369|133|P|the possible risk to the infant, breastfeeding is not recommended||
9369|134|P|while using this drug and for 2 months after the last dose.||
9369|135|P|Consult your doctor before breastfeeding.||
9369|136|B|||
9369|137|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9369|138|I|medications work or increase your risk for serious side effects.||
9369|139|I|This document does not contain all possible drug interactions.||
9369|140|I|Keep a list of all the products you use (including||
9369|141|I|prescription/nonprescription drugs and herbal products) and share||
9369|142|I|it with your doctor and pharmacist. Do not start, stop, or change||
9369|143|I|the dosage of any medicines without your doctor's approval.||
9369|144|I|   Other medications can affect the removal of bortezomib from||
9369|145|I|your body, which may affect how bortezomib works. Examples||
9369|146|I|include rifamycins (such as rifabutin), St. John's wort, drugs||
9369|147|I|used to treat seizures (such as carbamazepine, phenytoin), among||
9369|148|I|others.||
9369|149|B|||
9369|150|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9369|151|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9369|152|O|poison control center right away. US residents can call||
9369|153|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9369|154|O|Symptoms of overdose may include: severe dizziness, fainting, or||
9369|155|O|easy bleeding/bruising.||
9369|156|B|||
9369|157|N|NOTES:  Lab and/or medical tests (such as complete blood count)||
9369|158|N|should be done while you are using this medication. Keep all||
9369|159|N|medical and lab appointments. Consult your doctor for more||
9369|160|N|details.||
9369|161|B|||
9369|162|D|MISSED DOSE:  It is important to get each dose of this medication||
9369|163|D|as scheduled. If you miss a dose, ask your doctor or pharmacist||
9369|164|D|right away for a new dosing schedule.||
9369|165|B|||
9369|166|R|STORAGE:  Not applicable. This medication is given in a clinic||
9369|167|R|and will not be stored at home.||
9369|168|B|||
9369|169|M|MEDICAL ALERT:  Your condition can cause complications in a||
9369|170|M|medical emergency. For information about enrolling in MedicAlert,||
9369|171|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9369|172|B|||
9369|173|A|Information last revised May 2024.||
9369|174|A|Copyright(c) 2025 First Databank, Inc.||
9369|175|B|||
9371|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9371|002|Z|does NOT have all possible information about this product. This||
9371|003|Z|information does not assure that this product is safe, effective,||
9371|004|Z|or appropriate for you. This information is not individual||
9371|005|Z|medical advice and does not substitute for the advice of your||
9371|006|Z|health care professional. Always ask your health care||
9371|007|Z|professional for complete information about this product and your||
9371|008|Z|specific health needs.||
9371|009|B|||
9371|010|T|LISINOPRIL - ORAL||
9371|011|F|(lyse-IN-oh-pril)||
9371|012|B|||
9371|013|C|COMMON BRAND NAME(S): Prinivil, Zestril||
9371|014|B|||
9371|015|W|WARNING:  This medication can cause serious (possibly fatal) harm||
9371|016|W|to an unborn baby if used during pregnancy. It is important to||
9371|017|W|prevent pregnancy while taking this medication. Consult your||
9371|018|W|doctor for more details and to discuss the use of reliable forms||
9371|019|W|of birth control while taking this medication. If you are||
9371|020|W|planning pregnancy, become pregnant, or think you may be||
9371|021|W|pregnant, tell your doctor right away.||
9371|022|B|||
9371|023|U|USES:  Lisinopril is used to treat high blood pressure. Lowering||
9371|024|U|high blood pressure helps prevent strokes, heart attacks, and||
9371|025|U|kidney problems. It is also used to treat heart failure and to||
9371|026|U|improve survival after a heart attack.||
9371|027|U|   Lisinopril belongs to a class of drugs known as ACE||
9371|028|U|inhibitors. It works by relaxing blood vessels so blood can flow||
9371|029|U|more easily.||
9371|030|B|||
9371|031|V|OTHER USES:  This section contains uses of this drug that are not||
9371|032|V|listed in the approved professional labeling for the drug but||
9371|033|V|that may be prescribed by your health care professional. Use this||
9371|034|V|drug for a condition that is listed in this section only if it||
9371|035|V|has been so prescribed by your health care professional.||
9371|036|V|   This medication may also be used for kidney disease and to||
9371|037|V|help protect the kidneys from harm due to diabetes.||
9371|038|B|||
9371|039|H|HOW TO USE:  Take this medication by mouth with or without food||
9371|040|H|as directed by your doctor, usually once daily.||
9371|041|H|   If you are using the suspension form of this medication, shake||
9371|042|H|the bottle well before each dose. Carefully measure the dose||
9371|043|H|using a special measuring device/spoon. Do not use a household||
9371|044|H|spoon because you may not get the correct dose.||
9371|045|H|   The dosage is based on your medical condition and response to||
9371|046|H|treatment. Children's dosage is also based on weight.||
9371|047|H|   To reduce your risk of side effects, your doctor may direct||
9371|048|H|you to start this medication at a low dose and gradually increase||
9371|049|H|your dose. Follow your doctor's instructions carefully.||
9371|050|H|   Use this medication regularly to get the most benefit from it.||
9371|051|H|To help you remember, take it at the same time each day. Keep||
9371|052|H|taking this medication even if you feel well. Most people with||
9371|053|H|high blood pressure do not feel sick.||
9371|054|H|   For the treatment of high blood pressure, it may take 2 to 4||
9371|055|H|weeks before you get the full benefit of this medication. For the||
9371|056|H|treatment of heart failure, it may take weeks to months before||
9371|057|H|you get the full benefit of this medication. Tell your doctor if||
9371|058|H|your condition does not get better or if it gets worse (for||
9371|059|H|example, your blood pressure readings remain high or increase).||
9371|060|B|||
9371|061|S|SIDE EFFECTS:  Dizziness, lightheadedness, tiredness, or headache||
9371|062|S|may occur as your body adjusts to the medication. Dry cough may||
9371|063|S|also occur. If any of these effects last or get worse, tell your||
9371|064|S|doctor or pharmacist promptly.||
9371|065|S|   To reduce the risk of dizziness and lightheadedness, get up||
9371|066|S|slowly when rising from a sitting or lying position.||
9371|067|S|   Remember that this medication has been prescribed because your||
9371|068|S|doctor has judged that the benefit to you is greater than the||
9371|069|S|risk of side effects. Many people using this medication do not||
9371|070|S|have serious side effects.||
9371|071|S|   Tell your doctor right away if you have any serious side||
9371|072|S|effects, including: fainting, symptoms of a high potassium blood||
9371|073|S|level (such as muscle weakness, slow/irregular heartbeat).||
9371|074|S|   Although lisinopril may be used to prevent kidney problems or||
9371|075|S|treat people who have kidney problems, it may also rarely cause||
9371|076|S|serious kidney problems or make them worse. Your doctor will||
9371|077|S|check your kidney function while you are taking lisinopril. Tell||
9371|078|S|your doctor right away if you have any signs of kidney problems||
9371|079|S|such as a change in the amount of urine.||
9371|080|S|   This drug may rarely cause serious (possibly fatal) liver||
9371|081|S|problems. Get medical help right away if you have any symptoms of||
9371|082|S|liver damage, including: nausea/vomiting that doesn't stop, loss||
9371|083|S|of appetite, stomach/abdominal pain, yellowing eyes/skin, dark||
9371|084|S|urine.||
9371|085|S|   A very serious allergic reaction to this drug is rare.||
9371|086|S|However, get medical help right away if you notice any symptoms||
9371|087|S|of a serious allergic reaction, including: rash, itching/swelling||
9371|088|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9371|089|S|breathing.||
9371|090|S|   This is not a complete list of possible side effects. If you||
9371|091|S|notice other effects not listed above, contact your doctor or||
9371|092|S|pharmacist.||
9371|093|S|   In the US -||
9371|094|S|   Call your doctor for medical advice about side effects. You||
9371|095|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9371|096|S|www.fda.gov/medwatch.||
9371|097|S|   In Canada - Call your doctor for medical advice about side||
9371|098|S|effects. You may report side effects to Health Canada at||
9371|099|S|1-866-234-2345.||
9371|100|B|||
9371|101|P|PRECAUTIONS:  Before taking lisinopril, tell your doctor or||
9371|102|P|pharmacist if you are allergic to it; or to other ACE inhibitors||
9371|103|P|(such as benazepril); or if you have any other allergies. This||
9371|104|P|product may contain inactive ingredients, which can cause||
9371|105|P|allergic reactions or other problems. Talk to your pharmacist for||
9371|106|P|more details.||
9371|107|P|   Before using this medication, tell your doctor or pharmacist||
9371|108|P|your medical history, especially of: history of an allergic||
9371|109|P|reaction which included swelling of the face/lips/tongue/throat||
9371|110|P|(angioedema), blood filtering procedures (such as LDL apheresis,||
9371|111|P|dialysis), high level of potassium in the blood.||
9371|112|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9371|113|P|can make you more dizzy. Do not drive, use machinery, or do||
9371|114|P|anything that needs alertness until you can do it safely. Limit||
9371|115|P|alcoholic beverages. Talk to your doctor if you are using||
9371|116|P|marijuana (cannabis).||
9371|117|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
9371|118|P|and cause you to feel lightheaded. Tell your doctor if you have||
9371|119|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
9371|120|P|of fluids unless your doctor tells you not to.||
9371|121|P|   Before having surgery, tell your doctor or dentist about all||
9371|122|P|the products you use (including prescription drugs,||
9371|123|P|nonprescription drugs, and herbal products).||
9371|124|P|   This product may increase your potassium levels. Before using||
9371|125|P|potassium supplements or salt substitutes that contain potassium,||
9371|126|P|consult your doctor or pharmacist.||
9371|127|P|   Older adults may be more sensitive to the side effects of this||
9371|128|P|drug, especially dizziness and increases in potassium level.||
9371|129|P|   Tell your doctor if you are pregnant or plan to become||
9371|130|P|pregnant. You should not become pregnant while using lisinopril.||
9371|131|P|Lisinopril may harm an unborn baby. If you become pregnant, talk||
9371|132|P|to your doctor right away about the risks and benefits of this||
9371|133|P|medication. (See also Warning section.)||
9371|134|P|   It is unknown if this medication passes into breast milk.||
9371|135|P|Consult your doctor before breastfeeding.||
9371|136|B|||
9371|137|I|DRUG INTERACTIONS:  See also Precautions section.||
9371|138|I|   Drug interactions may change how your medications work or||
9371|139|I|increase your risk for serious side effects. This document does||
9371|140|I|not contain all possible drug interactions. Keep a list of all||
9371|141|I|the products you use (including prescription/nonprescription||
9371|142|I|drugs and herbal products) and share it with your doctor and||
9371|143|I|pharmacist. Do not start, stop, or change the dosage of any||
9371|144|I|medicines without your doctor's approval.||
9371|145|I|   Some products that may interact with this drug are: aliskiren,||
9371|146|I|certain drugs that weaken the immune system/increase the risk of||
9371|147|I|infection (such as everolimus, sirolimus), lithium, drugs that||
9371|148|I|may increase the level of potassium in the blood (such as ARBs||
9371|149|I|including losartan/valsartan, birth control pills containing||
9371|150|I|drospirenone), sacubitril.||
9371|151|I|   Some products have ingredients that could raise your blood||
9371|152|I|pressure or worsen your heart failure. Tell your pharmacist what||
9371|153|I|products you are using, and ask how to use them safely||
9371|154|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
9371|155|I|ibuprofen/naproxen).||
9371|156|I|   A very serious reaction may occur if you are getting||
9371|157|I|injections for bee/wasp sting allergy (desensitization) and are||
9371|158|I|also taking lisinopril. Make sure all your doctors know which||
9371|159|I|medicines you are using.||
9371|160|B|||
9371|161|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9371|162|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9371|163|O|poison control center right away. US residents can call||
9371|164|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9371|165|O|Symptoms of overdose may include: severe dizziness, fainting.||
9371|166|B|||
9371|167|N|NOTES:  Do not share this medication with others.||
9371|168|N|   Lifestyle changes that may help this medication work better||
9371|169|N|include exercising, stopping smoking, and eating a||
9371|170|N|low-cholesterol/low-fat diet. Consult your doctor for more||
9371|171|N|details.||
9371|172|N|   Lab and/or medical tests (such as kidney function, potassium||
9371|173|N|levels) should be done while you are taking this medication. Keep||
9371|174|N|all medical and lab appointments. Consult your doctor for more||
9371|175|N|details.||
9371|176|N|   Check your blood pressure and pulse (heart rate) regularly||
9371|177|N|while taking this medication. Learn how to check your own blood||
9371|178|N|pressure and pulse at home, and share the results with your||
9371|179|N|doctor.||
9371|180|B|||
9371|181|D|MISSED DOSE:  If you miss a dose, take it as soon as you||
9371|182|D|remember. If it is near the time of the next dose, skip the||
9371|183|D|missed dose. Take your next dose at the regular time. Do not||
9371|184|D|double the dose to catch up.||
9371|185|B|||
9371|186|R|STORAGE:  Store the tablets and suspension at room temperature||
9371|187|R|away from light and moisture. Do not store in the bathroom.||
9371|188|R|Discard any unused suspension after 4 weeks. Keep all medications||
9371|189|R|away from children and pets.||
9371|190|R|   Do not flush medications down the toilet or pour them into a||
9371|191|R|drain unless instructed to do so. Properly discard this product||
9371|192|R|when it is expired or no longer needed. Consult your pharmacist||
9371|193|R|or local waste disposal company.||
9371|194|B|||
9371|195|A|Information last revised August 2024.||
9371|196|A|Copyright(c) 2025 First Databank, Inc.||
9371|197|B|||
9372|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9372|002|Z|does NOT have all possible information about this product. This||
9372|003|Z|information does not assure that this product is safe, effective,||
9372|004|Z|or appropriate for you. This information is not individual||
9372|005|Z|medical advice and does not substitute for the advice of your||
9372|006|Z|health care professional. Always ask your health care||
9372|007|Z|professional for complete information about this product and your||
9372|008|Z|specific health needs.||
9372|009|B|||
9372|010|T|IRBESARTAN - ORAL||
9372|011|F|(ir-be-SAR-tan)||
9372|012|B|||
9372|013|C|COMMON BRAND NAME(S): Avapro||
9372|014|B|||
9372|015|W|WARNING:  This drug can cause serious (possibly fatal) harm to an||
9372|016|W|unborn baby if used during pregnancy. It is important to prevent||
9372|017|W|pregnancy while taking this medication. Consult your doctor for||
9372|018|W|more details and to discuss the use of reliable forms of birth||
9372|019|W|control while taking this medication. If you are planning||
9372|020|W|pregnancy, become pregnant, or think you may be pregnant, contact||
9372|021|W|your doctor right away.||
9372|022|B|||
9372|023|U|USES:  Irbesartan is used to treat high blood pressure||
9372|024|U|(hypertension) and to help protect the kidneys from damage due to||
9372|025|U|diabetes. Lowering high blood pressure helps prevent strokes,||
9372|026|U|heart attacks, and kidney problems. Irbesartan belongs to a class||
9372|027|U|of drugs called angiotensin receptor blockers (ARBs). It works by||
9372|028|U|relaxing blood vessels so that blood can flow more easily.||
9372|029|B|||
9372|030|V|OTHER USES:  This section contains uses of this drug that are not||
9372|031|V|listed in the approved professional labeling for the drug but||
9372|032|V|that may be prescribed by your health care professional. Use this||
9372|033|V|drug for a condition that is listed in this section only if it||
9372|034|V|has been so prescribed by your health care professional.||
9372|035|V|   This drug may also be used for heart failure. It may also be||
9372|036|V|used for kidney disease.||
9372|037|B|||
9372|038|H|HOW TO USE:  Take this medication by mouth with or without food||
9372|039|H|as directed by your doctor, usually once daily. The dosage is||
9372|040|H|based on your medical condition and response to treatment.||
9372|041|H|   Use this medication regularly to get the most benefit from it.||
9372|042|H|To help you remember, take it at the same time each day. Keep||
9372|043|H|taking this medication even if you feel well. Most people with||
9372|044|H|high blood pressure do not feel sick.||
9372|045|H|   Tell your doctor if your condition does not get better or if||
9372|046|H|it gets worse (for example, your blood pressure readings remain||
9372|047|H|high or increase).||
9372|048|B|||
9372|049|S|SIDE EFFECTS:  Dizziness, lightheadedness, or upset stomach may||
9372|050|S|occur as your body adjusts to the medication. If any of these||
9372|051|S|effects last or get worse, tell your doctor or pharmacist||
9372|052|S|promptly.||
9372|053|S|   To reduce the risk of dizziness and lightheadedness, get up||
9372|054|S|slowly when rising from a sitting or lying position.||
9372|055|S|   Remember that this medication has been prescribed because your||
9372|056|S|doctor has judged that the benefit to you is greater than the||
9372|057|S|risk of side effects. Many people using this medication do not||
9372|058|S|have serious side effects.||
9372|059|S|   Tell your doctor right away if you have any serious side||
9372|060|S|effects, including: fainting, symptoms of a high potassium blood||
9372|061|S|level (such as muscle weakness, slow/irregular heartbeat).||
9372|062|S|   Although irbesartan may be used to prevent kidney problems or||
9372|063|S|treat people who have kidney problems, it may also rarely cause||
9372|064|S|serious kidney problems or make them worse. Your doctor will||
9372|065|S|check your kidney function while you are taking irbesartan. Tell||
9372|066|S|your doctor right away if you have any signs of kidney problems||
9372|067|S|such as a change in the amount of urine.||
9372|068|S|   A very serious allergic reaction to this drug is rare.||
9372|069|S|However, get medical help right away if you notice any symptoms||
9372|070|S|of a serious allergic reaction, including: rash, itching/swelling||
9372|071|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9372|072|S|breathing.||
9372|073|S|   This is not a complete list of possible side effects. If you||
9372|074|S|notice other effects not listed above, contact your doctor or||
9372|075|S|pharmacist.||
9372|076|S|   In the US -||
9372|077|S|   Call your doctor for medical advice about side effects. You||
9372|078|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9372|079|S|www.fda.gov/medwatch.||
9372|080|S|   In Canada - Call your doctor for medical advice about side||
9372|081|S|effects. You may report side effects to Health Canada at||
9372|082|S|1-866-234-2345.||
9372|083|B|||
9372|084|P|PRECAUTIONS:  Before taking irbesartan, tell your doctor or||
9372|085|P|pharmacist if you are allergic to it; or if you have any other||
9372|086|P|allergies. This product may contain inactive ingredients, which||
9372|087|P|can cause allergic reactions or other problems. Talk to your||
9372|088|P|pharmacist for more details.||
9372|089|P|   Before using this medication, tell your doctor or pharmacist||
9372|090|P|your medical history, especially of: liver disease, dehydration,||
9372|091|P|high level of potassium in the blood.||
9372|092|P|   This drug may make you dizzy. Alcohol or marijuana (cannabis)||
9372|093|P|can make you more dizzy. Do not drive, use machinery, or do||
9372|094|P|anything that needs alertness until you can do it safely. Limit||
9372|095|P|alcoholic beverages. Talk to your doctor if you are using||
9372|096|P|marijuana (cannabis).||
9372|097|P|   Severe sweating, diarrhea, or vomiting may cause dehydration||
9372|098|P|and cause you to feel lightheaded. Tell your doctor if you have||
9372|099|P|severe diarrhea or vomiting. To prevent dehydration, drink plenty||
9372|100|P|of fluids unless your doctor tells you not to.||
9372|101|P|   This medication may increase your potassium levels. Before||
9372|102|P|using potassium supplements or salt substitutes that contain||
9372|103|P|potassium, consult your doctor or pharmacist.||
9372|104|P|   Before having surgery, tell your doctor or dentist about all||
9372|105|P|the products you use (including prescription drugs,||
9372|106|P|nonprescription drugs, and herbal products).||
9372|107|P|   Tell your doctor if you are pregnant or plan to become||
9372|108|P|pregnant. You should not become pregnant while using irbesartan.||
9372|109|P|Irbesartan may harm an unborn baby. If you become pregnant, talk||
9372|110|P|to your doctor right away about the risks and benefits of this||
9372|111|P|medication. (See also Warning section.)||
9372|112|P|   It is unknown if this drug passes into breast milk. Consult||
9372|113|P|your doctor before breastfeeding.||
9372|114|B|||
9372|115|I|DRUG INTERACTIONS:  See also Precautions section.||
9372|116|I|   Drug interactions may change how your medications work or||
9372|117|I|increase your risk for serious side effects. This document does||
9372|118|I|not contain all possible drug interactions. Keep a list of all||
9372|119|I|the products you use (including prescription/nonprescription||
9372|120|I|drugs and herbal products) and share it with your doctor and||
9372|121|I|pharmacist. Do not start, stop, or change the dosage of any||
9372|122|I|medicines without your doctor's approval.||
9372|123|I|   Some products that may interact with this drug include:||
9372|124|I|aliskiren, lithium, drugs that may increase the level of||
9372|125|I|potassium in the blood (such as sparsentan, ACE inhibitors||
9372|126|I|including benazepril/lisinopril, birth control pills containing||
9372|127|I|drospirenone).||
9372|128|I|   Some products have ingredients that could raise your blood||
9372|129|I|pressure or worsen your heart failure. Tell your pharmacist what||
9372|130|I|products you are using, and ask how to use them safely||
9372|131|I|(especially cough-and-cold products, diet aids, or NSAIDs such as||
9372|132|I|ibuprofen/naproxen).||
9372|133|B|||
9372|134|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9372|135|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9372|136|O|poison control center right away. US residents can call||
9372|137|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9372|138|O|Symptoms of overdose may include: severe dizziness, fainting.||
9372|139|B|||
9372|140|N|NOTES:  Do not share this medication with others.||
9372|141|N|   Lifestyle changes such as stress reduction programs, exercise,||
9372|142|N|and dietary changes may increase the effectiveness of this||
9372|143|N|medicine. Talk to your doctor or pharmacist about lifestyle||
9372|144|N|changes that might benefit you.||
9372|145|N|   Lab and/or medical tests (such as kidney function, potassium||
9372|146|N|levels) should be done while you are taking this medication. Keep||
9372|147|N|all medical and lab appointments. Consult your doctor for more||
9372|148|N|details.||
9372|149|N|   Check your blood pressure regularly while taking this||
9372|150|N|medication. Learn how to monitor your own blood pressure, and||
9372|151|N|share the results with your doctor.||
9372|152|B|||
9372|153|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9372|154|D|If it is near the time of the next dose, skip the missed dose.||
9372|155|D|Use your next dose at the regular time. Do not double the dose to||
9372|156|D|catch up.||
9372|157|B|||
9372|158|R|STORAGE:  Store at room temperature away from light and moisture.||
9372|159|R|Do not store in the bathroom. Keep all medications away from||
9372|160|R|children and pets.||
9372|161|R|   Do not flush medications down the toilet or pour them into a||
9372|162|R|drain unless instructed to do so. Properly discard this product||
9372|163|R|when it is expired or no longer needed. Consult your pharmacist||
9372|164|R|or local waste disposal company.||
9372|165|B|||
9372|166|A|Information last revised May 2024.||
9372|167|A|Copyright(c) 2025 First Databank, Inc.||
9372|168|B|||
9383|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9383|002|Z|does NOT have all possible information about this product. This||
9383|003|Z|information does not assure that this product is safe, effective,||
9383|004|Z|or appropriate for you. This information is not individual||
9383|005|Z|medical advice and does not substitute for the advice of your||
9383|006|Z|health care professional. Always ask your health care||
9383|007|Z|professional for complete information about this product and your||
9383|008|Z|specific health needs.||
9383|009|B|||
9383|010|T|PREDNISONE - ORAL||
9383|011|F|(PRED-ni-sone)||
9383|012|B|||
9383|013|C|COMMON BRAND NAME(S): Deltasone||
9383|014|B|||
9383|015|U|USES:  Prednisone is used to treat conditions such as arthritis,||
9383|016|U|blood disorders, breathing problems, severe allergies, skin||
9383|017|U|diseases, cancer, eye problems, and immune system disorders.||
9383|018|U|Prednisone belongs to a class of drugs known as corticosteroids.||
9383|019|U|It decreases your immune system's response to various diseases to||
9383|020|U|reduce symptoms such as swelling and allergic-type reactions.||
9383|021|B|||
9383|022|V|OTHER USES:  This section contains uses of this drug that are not||
9383|023|V|listed in the approved professional labeling for the drug but||
9383|024|V|that may be prescribed by your health care professional. Use this||
9383|025|V|drug for a condition that is listed in this section only if it||
9383|026|V|has been so prescribed by your health care professional.||
9383|027|V|   Prednisone may also be used for COVID-19, but is only||
9383|028|V|effective in hospitalized patients who need supplemental oxygen||
9383|029|V|or a mechanical ventilator to breathe.||
9383|030|B|||
9383|031|H|HOW TO USE:  Take this medication by mouth, with food or milk to||
9383|032|H|prevent stomach upset, as directed by your doctor. Take the||
9383|033|H|tablet form of this medication with a full glass of water (8||
9383|034|H|ounces/240 milliliters) unless your doctor directs you otherwise.||
9383|035|H|If you are using the liquid form of this medication, carefully||
9383|036|H|measure the dose using a special measuring device/spoon. Do not||
9383|037|H|use a household spoon because you may not get the correct dose.||
9383|038|H|If you are prescribed only one dose per day, take it in the||
9383|039|H|morning before 9 A.M.||
9383|040|H|   Take this medication exactly as directed by your doctor.||
9383|041|H|Follow the dosing schedule carefully. The dosage and length of||
9383|042|H|treatment are based on your medical condition and response to||
9383|043|H|treatment. If you are taking this medication on a different||
9383|044|H|schedule than a daily one (such as every other day), it may help||
9383|045|H|to mark your calendar with a reminder.||
9383|046|H|   Do not stop taking this medication without consulting your||
9383|047|H|doctor. Some conditions may become worse when this drug is||
9383|048|H|suddenly stopped. Also, you may experience symptoms such as||
9383|049|H|weakness, weight loss, nausea, muscle pain, headache, tiredness,||
9383|050|H|dizziness. To prevent these symptoms while you are stopping||
9383|051|H|treatment with this drug, your doctor may reduce your dose||
9383|052|H|gradually. Consult your doctor or pharmacist for more details.||
9383|053|H|Report any new or worsening symptoms right away.||
9383|054|H|   Tell your doctor if your condition lasts or gets worse.||
9383|055|B|||
9383|056|S|SIDE EFFECTS:  Nausea, vomiting, loss of appetite, heartburn,||
9383|057|S|trouble sleeping, increased sweating, or acne may occur. If any||
9383|058|S|of these effects last or get worse, tell your doctor or||
9383|059|S|pharmacist promptly.||
9383|060|S|   Remember that this medication has been prescribed because your||
9383|061|S|doctor has judged that the benefit to you is greater than the||
9383|062|S|risk of side effects. Many people using this medication do not||
9383|063|S|have serious side effects.||
9383|064|S|   Tell your doctor right away if you have any serious side||
9383|065|S|effects, including: muscle pain/cramps, irregular heartbeat,||
9383|066|S|weakness, swelling hands/ankles/feet, unusual weight gain, signs||
9383|067|S|of infection (such as sore throat that doesn't go away, fever,||
9383|068|S|chills), vision problems (such as blurred vision), symptoms of||
9383|069|S|stomach/intestinal bleeding (such as stomach/abdominal pain,||
9383|070|S|black/tarry stools, vomit that looks like coffee grounds),||
9383|071|S|mental/mood changes (such as depression, mood swings, agitation),||
9383|072|S|slow wound healing, thinning skin, bone pain, menstrual period||
9383|073|S|changes, puffy face, seizures, easy bruising/bleeding, red/purple||
9383|074|S|spots on the skin.||
9383|075|S|   This medication may rarely make your blood sugar rise, which||
9383|076|S|can cause or worsen diabetes. Tell your doctor right away if you||
9383|077|S|have symptoms of high blood sugar such as increased||
9383|078|S|thirst/urination. If you already have diabetes, check your blood||
9383|079|S|sugar regularly as directed and share the results with your||
9383|080|S|doctor. Your doctor may need to adjust your diabetes medication,||
9383|081|S|exercise program, or diet.||
9383|082|S|   A very serious allergic reaction to this product is rare.||
9383|083|S|However, get medical help right away if you notice any symptoms||
9383|084|S|of a serious allergic reaction, including: rash, itching/swelling||
9383|085|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9383|086|S|breathing.||
9383|087|S|   This is not a complete list of possible side effects. If you||
9383|088|S|notice other effects not listed above, contact your doctor or||
9383|089|S|pharmacist.||
9383|090|S|   In the US -||
9383|091|S|   Call your doctor for medical advice about side effects. You||
9383|092|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9383|093|S|www.fda.gov/medwatch.||
9383|094|S|   In Canada - Call your doctor for medical advice about side||
9383|095|S|effects. You may report side effects to Health Canada at||
9383|096|S|1-866-234-2345.||
9383|097|B|||
9383|098|P|PRECAUTIONS:  Before taking prednisone, tell your doctor or||
9383|099|P|pharmacist if you are allergic to it; or if you have any other||
9383|100|P|allergies. This product may contain inactive ingredients, which||
9383|101|P|can cause allergic reactions or other problems. Talk to your||
9383|102|P|pharmacist for more details.||
9383|103|P|   Before using this medication, tell your doctor or pharmacist||
9383|104|P|your medical history, especially of: current/past infections||
9383|105|P|(such as fungal infections, tuberculosis, herpes), heart problems||
9383|106|P|(such as heart failure, recent heart attack), high blood||
9383|107|P|pressure, thyroid problems, kidney disease, liver disease (such||
9383|108|P|as hepatitis B), stomach/intestinal problems (such as ulcer,||
9383|109|P|diverticulitis), bone loss (osteoporosis), mental/mood disorders||
9383|110|P|(such as psychosis, anxiety, depression), eye diseases (such as||
9383|111|P|cataracts, glaucoma), diabetes, mineral imbalance (such as low||
9383|112|P|level of potassium/calcium in the blood), seizures, blood clots,||
9383|113|P|bleeding problems, a certain adrenal gland tumor||
9383|114|P|(pheochromocytoma).||
9383|115|P|   Using corticosteroid medications for a long time can make it||
9383|116|P|more difficult for your body to respond to physical stress.||
9383|117|P|Before having surgery or emergency treatment, or if you get a||
9383|118|P|serious illness/injury, tell your doctor or dentist that you are||
9383|119|P|using this medication or have used this medication within the||
9383|120|P|past 12 months. Tell your doctor right away if you develop||
9383|121|P|unusual/extreme tiredness or weight loss. If you will be using||
9383|122|P|this medication for a long time, carry a warning card or medical||
9383|123|P|ID bracelet that identifies your use of this medication.||
9383|124|P|   Before having surgery, tell your doctor or dentist about all||
9383|125|P|the products you use (including prescription drugs,||
9383|126|P|nonprescription drugs, and herbal products).||
9383|127|P|   This medication may mask signs of infection. It can make you||
9383|128|P|more likely to get infections or may make current infections||
9383|129|P|worse. Stay away from anyone who has an infection that may easily||
9383|130|P|spread (such as chickenpox, COVID-19, measles, flu). Talk to your||
9383|131|P|doctor if you have been exposed to an infection or for more||
9383|132|P|details.||
9383|133|P|   The liquid form of this medication may contain sugar and/or||
9383|134|P|alcohol. Caution is advised if you have diabetes, liver disease,||
9383|135|P|or any other condition that requires you to limit/avoid these||
9383|136|P|substances in your diet. Ask your doctor or pharmacist about||
9383|137|P|using this product safely.||
9383|138|P|   Tell your health care professional that you are using||
9383|139|P|prednisone before having any immunizations/vaccinations. Avoid||
9383|140|P|contact with people who have recently received live vaccines||
9383|141|P|(such as flu vaccine inhaled through the nose).||
9383|142|P|   This medication may cause stomach bleeding. Daily use of||
9383|143|P|alcohol while using this medication may increase your risk for||
9383|144|P|stomach bleeding. Limit alcoholic beverages. Consult your doctor||
9383|145|P|or pharmacist for more information.||
9383|146|P|   Older adults may be more sensitive to the side effects of this||
9383|147|P|drug, especially bone loss/pain, stomach/intestinal bleeding, and||
9383|148|P|mental/mood changes (such as confusion).||
9383|149|P|   This medication may slow down a child's growth if used for a||
9383|150|P|long time. Consult the doctor or pharmacist for more details. See||
9383|151|P|the doctor regularly so your child's height and growth can be||
9383|152|P|checked.||
9383|153|P|   During pregnancy, this medication should be used only when||
9383|154|P|clearly needed. It may rarely harm an unborn baby. Discuss the||
9383|155|P|risks and benefits with your doctor. Infants born to mothers who||
9383|156|P|have been using this medication for an extended period of time||
9383|157|P|may have hormone problems. Tell your doctor right away if you||
9383|158|P|notice symptoms such as nausea/vomiting that doesn't stop, severe||
9383|159|P|diarrhea, or weakness in your newborn.||
9383|160|P|   This medication passes into breast milk but is unlikely to||
9383|161|P|harm a nursing infant. Consult your doctor before breastfeeding.||
9383|162|B|||
9383|163|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9383|164|I|medications work or increase your risk for serious side effects.||
9383|165|I|This document does not contain all possible drug interactions.||
9383|166|I|Keep a list of all the products you use (including||
9383|167|I|prescription/nonprescription drugs and herbal products) and share||
9383|168|I|it with your doctor and pharmacist. Do not start, stop, or change||
9383|169|I|the dosage of any medicines without your doctor's approval.||
9383|170|I|   Some products that may interact with this drug include:||
9383|171|I|aldesleukin, desmopressin, mifepristone, drugs that can cause||
9383|172|I|bleeding/bruising (including antiplatelet drugs such as||
9383|173|I|clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs||
9383|174|I|such as aspirin/celecoxib/ibuprofen).||
9383|175|I|   If your doctor has told you to take low-dose aspirin to||
9383|176|I|prevent heart attack or stroke (usually 81-162 milligrams a day),||
9383|177|I|you should keep taking the aspirin unless your doctor tells you||
9383|178|I|not to. Ask your doctor or pharmacist for more details.||
9383|179|I|   This medication may interfere with certain lab tests (such as||
9383|180|I|skin tests), possibly causing false test results. Make sure lab||
9383|181|I|personnel and all your doctors know you use this drug.||
9383|182|B|||
9383|183|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9383|184|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9383|185|O|poison control center right away. US residents can call||
9383|186|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9383|187|B|||
9383|188|N|NOTES:  Do not share this medication with others.||
9383|189|N|   If this medication is used for a long time, lab and/or medical||
9383|190|N|tests (such as blood mineral levels, blood glucose, complete||
9383|191|N|blood count, height/weight measurements, bone density tests,||
9383|192|N|blood pressure, eye exams) should be done while you are taking||
9383|193|N|this medication. Keep all medical and lab appointments. Consult||
9383|194|N|your doctor for more details||
9383|195|N|   This medication may cause bone loss (osteoporosis) when used||
9383|196|N|for a long time. Lifestyle changes that may help reduce the risk||
9383|197|N|of bone problems include doing weight-bearing exercise, stopping||
9383|198|N|smoking, limiting alcohol, and getting enough calcium and vitamin||
9383|199|N|D. Talk to your doctor for more details.||
9383|200|B|||
9383|201|D|MISSED DOSE:  If you are taking this medication daily and miss a||
9383|202|D|dose, take it as soon as you remember. If it is near the time of||
9383|203|D|the next dose, skip the missed dose. Take your next dose at the||
9383|204|D|regular time. Do not double the dose to catch up.||
9383|205|D|   If you are taking this medication on a different schedule than||
9383|206|D|a daily one (such as every other day), ask your doctor ahead of||
9383|207|D|time about what you should do if you miss a dose.||
9383|208|B|||
9383|209|R|STORAGE:  Store at room temperature away from light and moisture.||
9383|210|R|Do not store in the bathroom. Keep all medications away from||
9383|211|R|children and pets.||
9383|212|R|   Do not flush medications down the toilet or pour them into a||
9383|213|R|drain unless instructed to do so. Properly discard this product||
9383|214|R|when it is expired or no longer needed. Consult your pharmacist||
9383|215|R|or local waste disposal company.||
9383|216|B|||
9383|217|M|MEDICAL ALERT:  Your condition can cause complications in a||
9383|218|M|medical emergency. For information about enrolling in MedicAlert,||
9383|219|M|call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).||
9383|220|B|||
9383|221|A|Information last revised September 2025.||
9383|222|A|Copyright(c) 2025 First Databank, Inc.||
9383|223|B|||
9385|001|Z|IMPORTANT: HOW TO USE THIS INFORMATION:  This is a summary and||
9385|002|Z|does NOT have all possible information about this product. This||
9385|003|Z|information does not assure that this product is safe, effective,||
9385|004|Z|or appropriate for you. This information is not individual||
9385|005|Z|medical advice and does not substitute for the advice of your||
9385|006|Z|health care professional. Always ask your health care||
9385|007|Z|professional for complete information about this product and your||
9385|008|Z|specific health needs.||
9385|009|B|||
9385|010|T|CEFACLOR SUSPENSION - ORAL||
9385|011|F|(SEFF-uh-klor)||
9385|012|B|||
9385|013|C|COMMON BRAND NAME(S): Ceclor||
9385|014|B|||
9385|015|U|USES:  This medication is a cephalosporin-type antibiotic used to||
9385|016|U|treat a wide variety of bacterial infections (such as middle ear,||
9385|017|U|skin, urine and respiratory tract infections). It works by||
9385|018|U|stopping the growth of bacteria.||
9385|019|U|   This antibiotic only treats bacterial infections. It will not||
9385|020|U|work for viral infections (such as common cold, flu). Unnecessary||
9385|021|U|use or overuse of any antibiotic can lead to its decreased||
9385|022|U|effectiveness.||
9385|023|B|||
9385|024|H|HOW TO USE:  Shake the bottle well before each dose. Take this||
9385|025|H|medication by mouth with or without food as directed by your||
9385|026|H|doctor, usually every 8 or 12 hours. You may take this medicine||
9385|027|H|with food if stomach upset occurs.||
9385|028|H|   For the best effect, take this antibiotic at evenly spaced||
9385|029|H|times. To help you remember, take this medication at the same||
9385|030|H|time(s) every day.||
9385|031|H|   Continue to take this medication until the full prescribed||
9385|032|H|amount is finished, even if symptoms disappear after a few days.||
9385|033|H|Stopping the medication too early may result in a return of the||
9385|034|H|infection.||
9385|035|H|   Tell your doctor if your condition lasts or gets worse.||
9385|036|B|||
9385|037|S|SIDE EFFECTS:  Stomach upset, headache, nausea, vomiting, or||
9385|038|S|diarrhea may occur. If any of these effects last or get worse,||
9385|039|S|tell your doctor or pharmacist promptly.||
9385|040|S|   Remember that this medication has been prescribed because your||
9385|041|S|doctor has judged that the benefit to you is greater than the||
9385|042|S|risk of side effects. Many people using this medication do not||
9385|043|S|have serious side effects.||
9385|044|S|   Tell your doctor right away if you have any serious side||
9385|045|S|effects, including: signs of liver problems (such as||
9385|046|S|nausea/vomiting that doesn't stop, stomach/abdominal pain,||
9385|047|S|yellowing eyes/skin, dark urine), unusual joint pain, new signs||
9385|048|S|of infection (such as sore throat that doesn't go away, fever,||
9385|049|S|chills), easy bruising/bleeding, signs of kidney problems (such||
9385|050|S|as change in the amount of urine), mental/mood changes (such as||
9385|051|S|confusion).||
9385|052|S|   This medication may rarely cause a severe intestinal condition||
9385|053|S|due to a bacteria called C. difficile. This condition may occur||
9385|054|S|during treatment or weeks to months after treatment has stopped.||
9385|055|S|Tell your doctor right away if you develop: diarrhea that doesn't||
9385|056|S|stop, abdominal or stomach pain/cramping, blood/mucus in your||
9385|057|S|stool.||
9385|058|S|   If you have these symptoms, do not use anti-diarrhea or opioid||
9385|059|S|products because they may make symptoms worse.||
9385|060|S|   Use of this medication for prolonged or repeated periods may||
9385|061|S|result in oral thrush or a new vaginal yeast infection (oral or||
9385|062|S|vaginal fungal infection). Contact your doctor if you notice||
9385|063|S|white patches in your mouth, a change in vaginal discharge or||
9385|064|S|other new symptoms.||
9385|065|S|   A very serious allergic reaction to this drug is rare.||
9385|066|S|However, get medical help right away if you notice any symptoms||
9385|067|S|of a serious allergic reaction, including: rash, itching/swelling||
9385|068|S|(especially of the face/tongue/throat), severe dizziness, trouble||
9385|069|S|breathing.||
9385|070|S|   This is not a complete list of possible side effects. If you||
9385|071|S|notice other effects not listed above, contact your doctor or||
9385|072|S|pharmacist.||
9385|073|S|   In the US -||
9385|074|S|   Call your doctor for medical advice about side effects. You||
9385|075|S|may report side effects to FDA at 1-800-FDA-1088 or at||
9385|076|S|www.fda.gov/medwatch.||
9385|077|S|   In Canada - Call your doctor for medical advice about side||
9385|078|S|effects. You may report side effects to Health Canada at||
9385|079|S|1-866-234-2345.||
9385|080|B|||
9385|081|P|PRECAUTIONS:  Before taking cefaclor, tell your doctor or||
9385|082|P|pharmacist if you are allergic to it; or to penicillins or other||
9385|083|P|cephalosporins; or if you have any other allergies. This product||
9385|084|P|may contain inactive ingredients, which can cause allergic||
9385|085|P|reactions or other problems. Talk to your pharmacist for more||
9385|086|P|details.||
9385|087|P|   Before using this medication, tell your doctor or pharmacist||
9385|088|P|your medical history, especially of: kidney disease, intestinal||
9385|089|P|disease (colitis).||
9385|090|P|   Cefaclor may cause live bacterial vaccines (such as typhoid||
9385|091|P|vaccine) to not work well. Tell your health care professional||
9385|092|P|that you are using cefaclor before having any||
9385|093|P|immunizations/vaccinations.||
9385|094|P|   Before having surgery, tell your doctor or dentist about all||
9385|095|P|the products you use (including prescription drugs,||
9385|096|P|nonprescription drugs, and herbal products).||
9385|097|P|   During pregnancy, this medication should be used only when||
9385|098|P|clearly needed. Discuss the risks and benefits with your doctor.||
9385|099|P|   This medication passes into breast milk. Consult your doctor||
9385|100|P|before breastfeeding.||
9385|101|B|||
9385|102|I|DRUG INTERACTIONS:  Drug interactions may change how your||
9385|103|I|medications work or increase your risk for serious side effects.||
9385|104|I|This document does not contain all possible drug interactions.||
9385|105|I|Keep a list of all the products you use (including||
9385|106|I|prescription/nonprescription drugs and herbal products) and share||
9385|107|I|it with your doctor and pharmacist. Do not start, stop, or change||
9385|108|I|the dosage of any medicines without your doctor's approval.||
9385|109|I|   This medication may interfere with certain lab tests (such as||
9385|110|I|certain diabetic urine tests), possibly causing false test||
9385|111|I|results. Make sure lab personnel and all your doctors know you||
9385|112|I|use this drug.||
9385|113|B|||
9385|114|O|OVERDOSE:  If someone has overdosed and has serious symptoms such||
9385|115|O|as passing out or trouble breathing, call 911. Otherwise, call a||
9385|116|O|poison control center right away. US residents can call||
9385|117|O|1-800-222-1222. Canada residents can call 1-844-764-7669.||
9385|118|O|Symptoms of overdose may include severe vomiting, seizures.||
9385|119|B|||
9385|120|N|NOTES:  Do not share this medication with others.||
9385|121|N|   This medication has been prescribed for your current condition||
9385|122|N|only. Do not use it later for another infection unless your||
9385|123|N|doctor tells you to.||
9385|124|B|||
9385|125|D|MISSED DOSE:  If you miss a dose, use it as soon as you remember.||
9385|126|D|If it is near the time of the next dose, skip the missed dose.||
9385|127|D|Use your next dose at the regular time. Do not double the dose to||
9385|128|D|catch up.||
9385|129|B|||
9385|130|R|STORAGE:  Store in the refrigerator. Do not freeze. Discard any||
9385|131|R|unused portion after 14 days. Keep all medications away from||
9385|132|R|children and pets.||
9385|133|R|   Do not flush medications down the toilet or pour them into a||
9385|134|R|drain unless instructed to do so. Properly discard this product||
9385|135|R|when it is expired or no longer needed. Consult your pharmacist||
9385|136|R|or local waste disposal company.||
9385|137|B|||
9385|138|A|Information last revised May 2025.||
9385|139|A|Copyright(c) 2025 First Databank, Inc.||
9385|140|B|||
